EC Regulation No. 231/2012 PDF

22.3.

2012

EN

Official Journal of the European Union
L 83/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION REGULATION (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council
(Text with EEA relevance) THE EUROPEAN COMMISSION, (4)
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Articles 14 and 30(4) thereof, and Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (2), and in particular Article 7(5) thereof, Whereas:
(1)
The European Food Safety Authority (hereinafter the Authority) expressed its opinion on the safety of basic methacrylate copolymer (6) as a glazing agent. That food additive has subsequently been authorised on the basis of specific uses and has been allocated the number E 1205. Therefore specifications should be adopted for that food additive. Food colours ethyl ester of beta-apo-8'-carotenic acid (E 160 f), and brown FK (E 154), as well as the aluminium containing carrier bentonite (E 558) are not used any more according to information submitted by food manu facturers. Therefore, current specifications for those food additives should not be taken over to this Regulation. On 10 February 2010 the Authority expressed an opinion on the safety of sucrose esters of fatty acids (E 473) prepared from vinyl esters of fatty acids (7). Current specifications should be adapted accordingly in particular by reducing maximum limits for impurities of safety concern. Specific purity criteria currently applicable should be adapted by reducing maximum limits for individual heavy metals of interest where feasible and where the JECFA limits are lower than those currently in force. Pursuant to that approach maximum limits for the contaminant 4-methylimidazole in ammonia caramel (E 150 c), sulphated ash in beta-carotene (E 160 a (i)), and magnesium and alkali salts in calcium carbonate (E 170), should be lowered. That approach should be departed from only for additives trisodium citrate (E 331 (iii)) (lead content), carrageenan (E 407) and
(5)
Specifications relating to origin, purity criteria and any other necessary information should be adopted for food additives listed in the Union lists in Annex II and III to Regulation (EC) No 1333/2008. To that end, specifications previously developed for food additives in Commission Directive 2008/128/EC of 22 December 2008 laying down specific purity criteria concerning colours for use in foodstuffs (3), Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (4) and Commission Directive 2008/60/EC of 17 June 2008 laying down specific purity criteria concerning sweeteners for use in food stuffs (5) should be updated and taken over to this Regu lation. As a consequence, those Directives should be repealed. It is necessary to take into account the specifications and analytical techniques as set out in the Codex Alimentarius drafted by the Joint FAO/WHO Expert Committee on Food Additives (hereafter JECFA).
OJ OJ OJ OJ OJ L L L L L 354, 31.12.2008, p. 16. 354, 31.12.2008, p. 1. 6, 10.1.2009, p. 20. 253, 20.9.2008, p. 1. 158, 18.6.2008, p. 17.
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(1 ) (2 ) (3 ) (4 ) (5 )
(6) EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the use of Basic Methacrylate Copolymer as a food additive on request from the European Commission. EFSA Journal 2010; 8(2):1513. (7) EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the safety of sucrose esters of fatty acids prepared from vinyl esters of fatty acids and on the extension of use of sucrose esters of fatty acids in flavourings on request from the European Commission. EFSA Journal 2010; 8(3):1512.
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processed euchema seaweed (E407 a) (cadmium content), as manufacturers have declared that compliance with stricter Union provisions, reflecting JECFA limits, would not be technically feasible. The contribution to the total intake of those two contaminants (lead and cadmium) in those three individual food additives is not considered to be significant. On the contrary for phosphates (E 338-E 341 and E 450-E 452) new significantly lower values, compared to the ones indicated by JECFA, should be established due to new developments of the manufac turing processes, by taking into account the recent recommendations of the Authority on a reduction of the intake of arsenic, especially in the inorganic form (1). In addition, a new provision on arsenic for glutamic acid (E 620) should be introduced for safety reasons. The total balance of those adaptations benefits the consumers as maximum limits for heavy metals are becoming stricter in general and in most of the food additives. Detailed information on the production process and starting materials of a food additive should be included in the specifications to facilitate any future decision pursuant to Article 12 of Regulation (EC) No 1333/2008.
in (E (E (E
carageenan (E 407) and processed euchema seaweed 407 a), for particular microbiological criteria in agar 406) and for Salmonella spp. content in mannitol 421 (ii)) manufactured by fermentation.
(13)
The use of propan-2-ol (isopropanol, isopropyl alcohol) should be allowed for manufacturing the additives curcumin (E 100) and paprika extract (E 160 c), in line with JECFA specifications, as this particular use has been considered safe by the Authority (3). The use of ethanol in replacement of propan-2-ol in the manufacturing of gellan gum (E 418) should be permitted where the final product still complies with all other specifications and ethanol is considered to be of less safety concern.
(14)
The percentage of the colouring principle in cochineal, carminic acid, carmines (E 120) should be specified, as maximum limits are to apply to quantities of that principle.
(8)
Specifications should not make reference to organoleptic tests related to the taste as it cannot be expected by the control authorities to take the risk to taste a chemical substance.
(15)
The numbering system for subcategories of carotenes (E 160 a) should be updated in order to bring it in line with the Codex Alimentarius numbering system.
(16) (9)
Specifications should not make reference to classes as there is no added value in this reference.
(17)
The solid form of lactic acid (E 270) should also be included in the specifications, as it can now be manu factured in the solid form and there is no safety concern.
(10)
Specifications should not make reference to the general parameter Heavy metals as this parameter does not relate with toxicity, but rather with a generic analytical method. Parameters related to individual heavy metals are toxicity related and are included in the specifications.
The current temperature value in loss on drying for monosodium citrate (E 331 (i)), anhydrous form should be adjusted as under the currently listed conditions the substance decomposes. Drying conditions for trisodium citrate (E 331 (iii)) should also be adjusted to improve the reproducibility of the method.
(11)
Some food additives are currently listed under various names (carboxy methyl cellulose (E 466), cross-linked sodium carboxymethylcellulose (E 468), enzymatically hydrolised carboxymethylcellulose (E 469) and beeswax, white and yellow (E 901)) in various provisions of Directive 95/2/EC of the European Parliament and of the Council (2). Therefore the specifications established by this Regulation should refer to those various names.
(18)
The current specific absorption value for alphatocopherol (E 307) should be corrected and the sublimation point for sorbic acid (E 200) should be replaced by a solubility test as the former is not relevant. The specification of bacterial sources for the manufacturing of nisin (E 234) and natamycin (E 235) should be updated according to the current taxonomic nomenclature.
(12)
Current provisions on Polycyclic Aromatic Hydrocarbons (PAHs) are too generic and not relevant to safety and should be replaced by maximum limits for individual PAHs of concern for food additives vegetable carbon (E 153) and microcrystalline wax (E 905). Similar maximum limits should be established for formaldehyde
(19)
As new innovative manufacturing techniques resulting in less contaminated food additives are now available, the presence of aluminium in food additives should be restricted. In order to enhance legal certainty and nondiscrimination it is appropriate to provide the manufac turers of food additives with a transitional period to adapt gradually to those restrictions.
(1) EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on Arsenic in Food. EFSA Journal 2009; 7(10):1351. (2) OJ L 61, 18.3.1995, p. 1.
(3) EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the re-evaluation of curcumin (E 100) as a food additive. EFSA Journal 2010; 8(9):1679.
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Maximum limits for aluminium should be established for food additives where relevant, and particularly for calcium phosphates (E 341 (i)-(iii)) intended to be used in food for infants and young children (1), according to the relevant opinion of Scientific Committee on Food expressed on 7 June 1996 (2). In this framework a maximum limit for aluminum in calcium citrate (E 333) should also be established. The maximum limits for aluminium in calcium phos phates (E 341 (i)-(iii)), disodium diphosphate (E 450 (i)) and calcium dihydrogen diphosphate (E 450 (vii)) should be in accordance with the opinion of the Authority of 22 May 2008 (3). Current limits should be reduced, where this is technically feasible, and where the contribution to the total aluminium intake is significant. In this framework aluminium lakes of individual food colours should be authorised only if technically needed. Provisions on maximum limits for aluminium in dicalcium phosphate (E 341 (ii)), tricalcium phosphate (E 341 (iii)) and calcium dihydrogen diphosphate (E 450 (vii)) should not cause any disruption of the market, due to a possible lack of supplies. According to Commission Regulation (EU) No 258/2010 of 25 March 2010 imposing special conditions on the imports of guar gum originating in or consigned from India due to contamination risks by pentachlorophenol and dioxins (4), maximum limits should be set for the contaminant pentachlorophenol in guar gum (E 412). According to recital 48 of Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (5) Member States are requested to examine other foodstuffs than the ones included in that Regulation for the occurrence of contaminant 3-MCPD in order to consider the need to set maximum levels for that substance. French authorities have submitted data on high concentrations of 3-MCPD in the food additive glycerol (E 422) and the average use level of this food additive in various food categories. Maximum limits for 3-MCPD in this particular food additive should be set in order to avoid contamination of the final food at a higher than permissible level, taking into account the dilution factor. Due to the development of analytical methods certain current specifications should be updated. The current
limit value not detectable is linked to the evolution of analytical methodologies and should be replaced by a specific number for additives acid esters of mono- and diglycerides (E 472 a-f), polyglycerol esters of fatty acids (E 475) and propane-1,2-diol esters of fatty acids (E 477).
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Specifications relating to the manufacturing procedure should be updated for citric acid esters of mono- and diglycerides of fatty acids (E 472 c), as the use of alkaline bases is replaced today by the use of their milder acting salts.
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The current criterion free fatty acids for additives citric acid esters of mono- and diglycerides of fatty acids (E 472 c) and mono- and diacetyltartaric acid esters of mono- and diglycerides of fatty acids (E 472 e) is not appropriate. It should be replaced by the criterion acid value as the latter expresses better the titrimetric esti mation of the free acidic groups. This is in accordance with the 71st report on food additives from JECFA (6) where such change was adopted for mono- and diace tyltartaric acid esters of mono- and diglycerides of fatty acids (E 472 e).
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The current erroneous description of additive magnesium oxide (E 530) should be corrected according to information submitted by the manufacturers, in order to bring it in line with the Pharmacopoeia Europea (7). The current maximum value for the reducing matter in additive gluconic acid (E 574) should also be updated as this limit is not technically feasible. For the estimation of the water content of xylitol (E 967) the current method based on loss on drying, should be replaced by a more appropriate method.
(29)
Some current specifications for additive candelilla wax (E 902) should not be taken over to this Regulation since they are erratic. For calcium dihydrogen diphosphate (E 450 (vii)) the current entry concerning P2O5 content should be corrected.
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In the current entry assay for thaumatin (E 957) a calcu lation factor should be corrected. That factor is to be used in the Kjeldahl method for the estimation of the total content of the substance based on the measurement of nitrogen. The calculation factor should be updated according to the relevant published literature for thaumatin (E 957).
(1) As defined in Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (codified version), OJ L 339, 6.12.2006, p. 16. (2) Opinion on Additives in nutrient preparations for use in infant formulae, follow-on formulae and weaning foods. Reports of the Scientific Committee on food (40th Series), p. 13-30, (1997). (3) Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Food Contact Materials on a request from European Commission on Safety of aluminium from dietary intake. EFSA Journal (2008) 754, 1-34. (4) OJ L 80, 26.3.2010, p. 28. (5) OJ L 364, 20.12.2006, p. 5.
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The Authority evaluated the safety of steviol glycosides, as a sweetener and expressed its opinion of 10 March 2010 (8). The use of steviol glycosides, which have been
(6) WHO Technical Report Series, No 956, 2010. (7) EP 7.0 volume 2, p. 2415-2416. (8) EFSA Panel on Food Additives and Nutrient Sources (ANS); Scientific Opinion on the safety of steviol glycosides for the proposed uses as a food additive. EFSA Journal (2010); 8(4):1537.
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allocated number E 960, has subsequently been permitted on the basis of well defined conditions of use. Therefore specifications should be adopted for this food additive.
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The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,
Due to a taxonomic change, current specifications for source materials (yeasts) used in the manufacturing of erythritol (E 968) should be updated. For quillaia extract (E 999) the current specification relating to the pH range should be adjusted in order to bring it in line with JECFA. The combination of citric acid and phosphoric acid (which are currently both individually authorised for use in the manufacturing of additive polydextrose (E 1200)), should be allowed, where the final product still complies with the purity specifications, as it improves yields and results to more controllable reaction kinetics. There is no safety concern involved in such amendment. Unlike for small molecules, the molecular mass of a polymer is not one unique value. A given polymer may have a distribution of molecules with different masses. The distribution may depend on the way the polymer is produced. Polymer physical properties and behaviors are related to the mass and to the distribution of molecules with a certain mass in the mixture. A group of mathematical models describe the mixture in different ways in order to clarify the distribution of molecules in the mixture. Among the different models available, it is recommended in scientific literature to use the weight average molecular weight (Mw) to describe polymers. The specifications for polyvinylpyrrolidone (E 1201) should be adjusted accordingly. The criterion Distillation range referred to in current specifications for propane-1,2 diol (E 1520) leads to contradictory conclusions compared to results from the assay. That criterion should therefore be corrected and renamed into Distillation test.
HAS ADOPTED THIS REGULATION:
Article 1
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Specifications for food additives Specifications for food additives including colours and sweeteners listed in Annex II and III to Regulation (EC) No 1333/2008 are laid down in the Annex to this Regulation. Article 2 Repeals Directives 2008/60/EC, 2008/84/EC and 2008/128/EC are repealed with effect from 1 December 2012. Article 3 Transitional measures Foodstuffs containing food additives that have been lawfully placed on the market before 1 December 2012, but do not comply with this Regulation, may continue to be marketed until stocks are exhausted. Article 4 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. It shall apply from 1 December 2012.
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However, the specifications laid down in the Annex for additives steviol glycosides (E 960) and basic methacrylate copolymer (E 1205) shall apply from the date of entry into force of this Regulation.
This Regulation shall be binding in its entirety and directly applicable in the Member States.
Done at Brussels, 9 March 2012. For the Commission The President

Jos Manuel BARROSO
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ANNEX Note: Ethylene oxide may not be used for sterilising purposes in food additives Aluminium lakes for use in colours only where explicitly stated. Definition: Aluminium lakes are prepared by reacting colours complying with the purity criteria set out in the appropriate specification monograph with alumina under aqueous conditions. The alumina is usually freshly prepared undried material made by reacting aluminium sulphate or chloride with sodium or calcium carbonate or bicarbonate or ammonia. Following lake formation, the product is filtered, washed with water and dried. Unreacted alumina may also be present in the finished product. Not more than 0,5 % ot more than 0,5 %, for 127 erythrosine only Not more than 0,2 % (under neutral conditions) Specific purity criteria for the corresponding colours are applicable.
HCl insoluble matter a insoluble matter Ether extractable matter
E 100 CURCUMIN Synonyms Definition CI Natural Yellow 3; Turmeric Yellow; Diferoyl Methane Curcumin is obtained by solvent extraction of turmeric i.e. the ground rhizomes of strains of Curcuma longa L. In order to obtain a concen trated curcumin powder, the extract is purified by crystallization. The product consists essentially of curcumins; i.e. the colouring principle (1,7-bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-dien-3,5-dione) and its two desmethoxy derivatives in varying proportions. Minor amounts of oils and resins naturally occurring in turmeric may be present. Curcumin is also used as the aluminium lake; the aluminium content is less than 30 %. Only the following solvents may be used in the extraction: ethy lacetate, acetone, carbon dioxide, dichloromethane, n-butanol, methanol, ethanol, hexane, propan-2-ol. Colour Index No Einecs Chemical name 75300 207-280-5 I 1,7-Bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-diene-3,5-dione
II 1-(4-Hydroxyphenyl)-7-(4-hydroxy-3-methoxy-phenyl-)hepta-1,6diene-3,5-dione III 1,7-Bis(4-hydroxyphenyl)hepta-1,6-diene-3,5-dione Chemical formula I C21H20O6
II C20H18O5 III C19H16O4 Molecular weight Assay I. 368,39 II. 338,39 III. 308,39
Content not less than 90 % total colouring matters E1% 1cm 1 607 at ca. 426 nm in ethanol
Description
Orange-yellow crystalline powder
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Identification Spectrometry Melting range Purity Solvent residues Ethylacetate Acetone n-butanol Methanol Ethanol Hexane Propan-2-ol 9 > > > > > > > > > > > > > > > > > > > > > > > > > > = Maximum in ethanol at ca. 426 nm 179 C-182 C
Dichloromethane: not more than 10 mg/kg Arsenic Lead Mercury Cadmium Aluminium lakes of this colour may be used. Not more than 3 mg/kg Not more than 10 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
Not more than 50 mg/kg, singly or in combination > > > > > > > > > > > > > > > > > > > > > > > > > > ;
E 101 (i) RIBOFLAVIN Synonyms Definition Colour Index No Einecs Chemical name 201-507-1 7,8-Dimethyl-10-(D-ribo-2,3,4,5-tetrahydroxypentyl)benzo(g)pteridine2,4(3H,10H)-dione; 7,8-dimethyl-10-(1-D-ribityl)isoalloxazine C17H20N4O6 376,37 Content not less than 98 % on the anhydrous basis E1% 1cm 328 at ca. 444 nm in aqueous solution Description Yellow to orange-yellow crystalline powder, with slight odour Lactoflavin;
Chemical formula Molecular weight Assay
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Identification Spectrometry The ratio A375/A267 is between 0,31 and 0,33 The ratio A444/A267 is between 0,36 and 0,39 Maximum in water at ca. 375 nm Specific rotation 9 > > > > > = > > > > > ;
in aqueous solution
[]D20 between 115 and 140 in a 0,05 N sodium hydroxide solution
Purity Loss on drying Sulphated ash Primary aromatic amines Arsenic Lead Mercury Cadmium Not more than 1,5 % (105 C, 4 hours) Not more than 0,1 % Not more than 100 mg/kg (calculated as aniline) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 101 (ii) RIBOFLAVIN-5-PHOSPHATE Synonyms Definition Riboflavin-5-phosphate sodium These specifications apply to riboflavin 5-phosphate together with minor amounts of free riboflavin and riboflavin diphosphate.
Colour Index No Einecs Chemical name 204-988-6 Monosodium(2R,3R,4S)-5-(3)10-dihydro-7,8-dimethyl-2,4-dioxo10-benzo[]pteridinyl)-2,3,4-trihydroxypentyl phosphate; mono sodium salt of 5-monophosphate ester of riboflavin For the dihydrate form: C17H20N4NaO9P 2H2O For the anhydrous form: C17H20N4NaO9P Molecular weight Assay 514,36 Content not less than 95 % total colouring matters calculated as C17H20N4NaO9P.2H2O E1% 1cm 250 at ca. 375 nm in aqueous solution
Chemical formula
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Description Identification Spectrometry
Yellow to orange crystalline hygroscopic powder, with slight odour
The ratio A375/A267 is between 0,30 and 0,34 The ratio A444/A267 is between 0,35 and 0,40 Maximum in water at ca. 375 nm
9 > > > > > = > > > > > ;
in aqueous solution
Specific rotation Purity Loss on drying
[]D20 between + 38 and + 42 in a 5 molar HCl solution
Not more than 8 % (100 C, 5 hours in vacuum over P2O5) for the dihydrate form Not more than 25 % Not more than 1,0 % (calculated as PO4 on the anhydrous basis) Riboflavin (free): Not more than 6 % Riboflavine diphosphate: Not more than 6 %
Sulphated ash Inorganic phosphate Subsidiary colouring matters
Primary aromatic amines Arsenic Lead Mercury Cadmium
Not more than 70 mg/kg (calculated as aniline) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 102 TARTRAZINE Synonyms Definition CI Food Yellow 4 Tartrazine is prepared from 4-amino-benzenesulphonic acid, which is diazotized using hydrochloric acid and sodium nitrite. The diazo compound is then coupled with 4,5-dihydro-5-oxo-1-(4sulphop henyl)-1H-pyrazole-3-carboxylic acid or with the methyl ester, the ethyl ester, or a salt of this carboxylic acid. The resulting dye is purified and isolated as the sodium salt. Tartrazine consists essentially of trisodium 5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatopheny lazo)-H-pyrazole-3-carboxylate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Tartrazine is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No Einecs Chemical name 19140 217-699-5 Trisodium-5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)H-pyrazole-3-carboxylate
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C16H9N4Na3O9S2 534,37 Content not less than 85 % total colouring matters calculated as the sodium salt E1% 1cm 530 at ca. 426 nm in aqueous solution
Description Appearance of the aqueous solution Identification Spectrometry Purity Water insoluble matter Subsidiary colouring matters Organic compounds colouring matters: other than
Light orange powder or granules Yellow
Maximum in water at ca. 426 nm
Not more than 0,2 % Not more than 1,0 %
4-hydrazinobenzene acid
sulfonic
4-aminobenzene-1-sulfonic acid 5-oxo-1-(4-sulfophenyl)-2-pyra zoline-3-carboxylic acid 4,4-diazoaminodi(benzene sulfonic acid) Tetrahydroxysuccinic acid Unsulfonated primary aromatic amines Ether extractable matter Arsenic Lead Mercury Cadmium Aluminium lakes of this colour may be used.
9 > > > > > > > > > > > > > > > > > > > > > > > > > = > > > > > > > > > > > > > > > > > > > > > > > > > ;
Total not more than 0,5 %
Not more than 0,01 % (calculated as aniline) Not more than 0,2 % under neutral conditions
Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
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E 104 QUINOLINE YELLOW Synonyms Definition CI Food Yellow 13 Quinoline Yellow is prepared by sulfonating 2-(2-quinolyl) indan-1,3dione or a mixture containing about two thirds 2-(2-quinolyl)indane1,3-dione and one third 2-(2-(6-methylquinolyl))indane-1,3-dione. Quinoline Yellow consists essentially of sodium salts of a mixture of disulfonates (principally), monosulfonates and trisulfonates of the above compound and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Quinoline Yellow is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No Einecs Chemical name 47005 305-897-5 The disodium salts of the disulfonates of 2-(2-quinolyl) indan-1,3-dione (principal component) C18H9N Na2O8S2 (principal component) 477,38 (principal component) Content not less than 70 % total colouring matters calculated as the sodium salt Quinoline Yellow shall have the following composition: Of the total colouring matters present: not less than 80 % shall be disodium 2-(2-quinolyl) indan-1,3dione-disulfonates not more than 15 % shall be sodium 2-(2-quinolyl) indan-1,3dione-monosulfonates not more than 7,0 % shall be trisodium 2-(2-quinolyl) indan-1,3dione-trisulfonate E1% 1cm 865 (principal component) at ca. 411 nm in aqueous acetic acid solution Description Appearance of the aqueous solution Identification Spectrometry Purity Water insoluble matter Subsidiary colouring matters Organic compounds colouring matters: other than Not more than 0,2 % Not more than 4,0 % Maximum in aqueous acetic acid solution of pH 5 at ca. 411 nm Yellow powder or granules Yellow
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9 > > > > > > > > > > > > > > > > > = > > > > > > > > > > > > > > > > > ;
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2-methylquinoline 2-methylquinoline-sulfonic acid Phthalic acid 2,6-dimethyl quinoline 2,6-dimethyl quinoline sulfonic acid 2-(2-quinolyl)indan-1,3-dione Unsulfonated primary aromatic amines Ether extractable matter Arsenic Lead Mercury Cadmium Aluminium lakes of this colour may be used.
Not more than 4 mg/kg Not more than 0,01 % (calculated as aniline) Not more than 0,2 % under neutral conditions Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 110 SUNSET YELLOW FCF Synonyms Definition CI Food Yellow 3; Orange Yellow S Sunset Yellow FCF consists essentially of disodium 2-hydroxy-1-(4sulfonatophenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Sunset Yellow FCF is manufactured by diazotizing 4-aminobenzenesulphonic acid using hydrochloric acid and sodium nitrite or sulphuric acid and sodium nitrite. The diazo compound is coupled with 6-hydroxy-2-naphthalene-sulphonic acid. The dye is isolated as the sodium salt and dried. Sunset Yellow FCF is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No Einecs Chemical name Chemical formula Molecular weight Assay 15985 220-491-7 Disodium 2-hydroxy-1-(4-sulfonatophenylazo)naphthalene-6-sulfonate C16H10N2Na2O7S2 452,37 Content not less than 85 % total colouring matters calculated as the sodium salt E1% 1cm 555 at ca. 485 nm in aqueous solution at pH 7 Description Appearance of the aqueous solution Orange-red powder or granules Orange
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Identification Spectrometry Purity Water insoluble matter Subsidiary colouring matters 1-(Phenylazo)-2-naphthalenol (Sudan I) Organic compounds colouring matters: other than 9 > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > = > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > ; Not more than 0,2 % Not more than 5,0 % Not more than 0,5 mg/kg Maximum in water at ca. 485 nm at pH 7
4-aminobenzene-1-sulfonic acid 3-hydroxynaphthalene-2,7disulfonic acid 6-hydroxynaphthalene-2-sulfonic acid 7-hydroxynaphthalene-1,3disulfonic acid 4,4-diazoaminodi(benzene sulfonic acid) 6,6-oxydi(naphthalene-2sulfonic acid) Unsulfonated primary aromatic amines Ether extractable matter Arsenic Lead Mercury Cadmium Aluminium lakes of this colour may be used.
E 120 COCHINEAL, CARMINIC ACID, CARMINES Synonyms Definition CI Natural Red 4 Carmines and carminic acid are obtained from aqueous, aqueous alcoholic or alcoholic extracts from Cochineal, which consists of the dried bodies of the female insect Dactylopius coccus Costa. The colouring principle is carminic acid. Aluminium lakes of carminic acid (carmines) can be formed in which aluminium and carminic acid are thought to be present in the molar ratio 1:2.
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In commercial products the colouring principle is present in association with ammonium, calcium, potassium or sodium cations, singly or in combination, and these cations may also be present in excess. Commercial products may also contain proteinaceous material derived from the source insect, and may also contain free carminate or a small residue of unbound aluminium cations. Colour Index No Einecs Chemical name 75470 Cochineal: 215-680-6; carminic acid: 215-023-3; carmines: 215-724-4 7--D-glucopyranosyl-3,5,6,8-tetrahydroxy-1-methyl-9,10-dioxoan thracene-2-carboxylic acid (carminic acid); carmine is the hydrated aluminium chelate of this acid C22H20O13 (carminic acid) 492,39 (carminic acid) Content not less than 2,0 % carminic acid in the extracts containing carminic acid; not less than 50 % carminic acid in the chelates. Red to dark red, friable, solid or powder. Cochineal extract is generally a dark red liquid but can also be dried as a powder.
Description
Identification Spectrometry Maximum in aqueous ammonia solution at ca. 518 nm Maximum in dilute hydrochloric solution at ca. 494 nm for carminic acid E1% 1cm 139 at peak around 494 nm in dilute hydrochloric acid for carminic acid Purity Arsenic Lead Mercury Cadmium Aluminium lakes of this colour may be used. Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 122 AZORUBINE, CARMOISINE Synonyms Definition CI Food Red 3 Azorubine consists essentially of disodium 4-hydroxy-3-(4-sulfonato-1naphthylazo) naphthalene-1-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Azorubine is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No 14720
L 83/14
EN
22.3.2012
Einecs Chemical name
222-657-4 Disodium sulfonate 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-
C20H12N2Na2O7S2 502,44 Content not less than 85 % total colouring matters, calculated as the sodium salt E1% 1cm 510 at ca. 516 nm in aqueous solution
Red to maroon powder or granules Red
Maximum in water at ca. 516 nm
Not more than 0,2 % Not more than 1 %
4-aminonaphthalene-1-sulfonic acid 4-hydroxynaphthalene-1-sulfonic acid Unsulfonated primary aromatic amines Ether extractable matter Arsenic Lead Mercury Cadmium Aluminium lakes of this colour may be used.
9 > > > > = > > > > > ;
E 123 AMARANTH Synonyms Definition CI Food Red 9 Amaranth consists essentially of trisodium 2-hydroxy-1-(4-sulfonato-1naphthylazo) naphthalene-3,6-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Amaranth is manufactured by coupling 4-amino-1-naphthalenesulphonic acid with 3-hydroxy-2,7naphthalenedisulphonic acid.
22.3.2012
EN
L 83/15
Amaranth is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No Einecs Chemical name 16185 213-022-2 Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6disulfonate C20H11N2Na3O10S3 604,48 Content not less than 85 % total colouring matters, calculated as the sodium salt E1% 1cm 440 at ca. 520 nm in aqueous solution Description Appearance of the aqueous solution Identification Spectrometry Purity Water insoluble matter Subsidiary colouring matters Organic compounds colouring matters: other than 9 > > > > > > > > > > > > > > > > > > > > > > > > = > > > > > > > > > > > > > > > > > > > > > > > > ; Not more than 0,2 % Not more than 3,0 % Maximum in water at ca. 520 nm Reddish-brown powder or granules Red
4-aminonaphthalene-1-sulfonic acid 3-hydroxynaphthalene-2,7disulfonic acid 6-hydroxynaphthalene-2-sulfonic acid 7-hydroxynaphthalene-1,3disulfonic acid 7-hydroxynaphthalene-1,3-6trisulfonic acid Unsulfonated primary aromatic amines Ether extractable matter Arsenic Lead Mercury Cadmium Aluminium lakes of this colour may be used.
L 83/16
EN
22.3.2012
E 124 PONCEAU 4R, COCHINEAL RED A Synonyms Definition CI Food Red 7; New Coccine Ponceau 4R consists essentially of trisodium 2-hydroxy-1-(4-sulfonato1-naphthylazo) naphthalene-6,8-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Ponceau 4R is manufactured by coupling diazotized naphthionic acid to G acid (2-naphthol-6,8disulphonic acid) and converting the coupling product to the trisodium salt. Ponceau 4R is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No Einecs Chemical name 16255 220-036-2 Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8disulfonate C20H11N2Na3O10S3 604,48 Content not less than 80 % total colouring matters, calculated as the sodium salt. E1% 1cm 430 at ca. 505 nm in aqueous solution Description Appearance of the aqueous solution Identification Spectrometry Purity Water insoluble matter Subsidiary colouring matters Organic compounds colouring matters: other than 9 > > > > > > > > > > > > > > > > > > > > > > > > = > > > > > > > > > > > > > > > > > > > > > > > > ; Not more than 0,2 % Not more than 1,0 % Maximum in water at ca. 505 nm Reddish powder or granules Red
4-aminonaphthalene-1-sulfonic acid 7-hydroxynaphthalene-1,3disulfonic acid 3-hydroxynaphthalene-2,7disulfonic acid 6-hydroxynaphthalene-2-sulfonic acid 7-hydroxynaphthalene-1,3-6trisulfonic acid Unsulfonated primary aromatic amines
Not more than 0,01 % (calculated as aniline)
22.3.2012
EN
L 83/17
Ether extractable matter Arsenic Lead Mercury Cadmium Aluminium lakes of this colour may be used.
Not more than 0,2 % under neutral conditions Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 127 ERYTHROSINE Synonyms Definition CI Food Red 14 Erythrosine consists essentially of disodium 2-(2,4,5,7-tetraiodo-3oxido-6-oxoxanthen-9-yl) benzoate monohydrate and subsidiary colouring matters together with water, sodium chloride and/or sodium sulphate as the principal uncoloured components. Erythrosine is manufactured by iodination of fluorescein, the condensation product of resorcinol and phthalic anhydride Erythrosine is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No Einecs Chemical name 45430 240-474-8 Disodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl)benzoate monohydrate C20H6I4Na2O5 H2O 897,88 Content not less than 87 % total colouring matters, calculated as the anhydrous sodium salt E1% 1cm 1 100 at ca. 526 nm in aqueous solution at pH 7 Description Appearance of the aqueous solution Identification Spectrometry Purity Inorganic iodides Water insoluble matter Subsidiary colouring matters (except fluorescein) Fluorescein Not more than 0,1 % (calculated as sodium iodide) Not more than 0,2 % Not more than 4,0 % Maximum in water at ca. 526 nm at pH 7 Red powder or granules. Red
Not more than 20 mg/kg
L 83/18
EN
22.3.2012
Organic compounds colouring matters: Tri-iodoresorcinol
other
than
2-(2,4-dihydroxy-3,5-diiodo benzoyl) benzoic acid Ether extractable matter Arsenic Lead Mercury Cadmium Aluminium Lakes of this colour may be used.
From a solution of pH from 7 through 8, not more than 0,2 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 129 ALLURA RED AC Synonyms Definition CI Food Red 17 Allura Red AC consists essentially of disodium 2-hydroxy-1-(2methoxy-5-methyl-4-sulfonato-phenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Allura Red AC is manufactured by coupling diazotized 5-amino-4-methoxy-2toluenesulphonic acid with 6-hydroxy-2-naphthalene sulphonic acid Allura Red AC is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No Einecs Chemical name 16035 247-368-0 Disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonatophenylazo) naphthalene-6-sulfonate C18H14N2Na2O8S2 496,42 Content not less than 85 % total colouring matters, calculated as the sodium salt E1% 1cm 540 at ca. 504 nm in aqueous solution at pH 7 Description Appearance of the aqueous solution Identification Spectrometry Maximum in water at ca. 504 nm Dark red powder or granules Red
22.3.2012
EN
L 83/19
Purity Water insoluble matter Subsidiary colouring matters Organic compounds colouring matters: other than Not more than 0,2 % Not more than 3,0 %
6-hydroxy-2-naphthalene sulfonic acid, sodium salt 4-amino-5-methoxy-2-methyl benezene sulfonic acid 6,6-oxybis (2-naphthalene sulfonic acid) disodium salt Unsulfonated primary aromatic amines Ether extractable matter Arsenic Lead Mercury Cadmium Aluminium lakes of this colour may be used.
Not more than 0,3 %
Not more than 0,2 %
Not more than 1,0 %
Not more than 0,01 % (calculated as aniline) From a solution of pH 7, not more than 0,2 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 131 PATENT BLUE V Synonyms Definition CI Food Blue 5 Patent Blue V consists essentially of the calcium or sodium compound of [4-(-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methyl idene)2,5-cyclohexadien-1-ylidene] diethylammonium hydroxide inner salt and subsidiary colouring matters together with sodium chloride and/or sodium sulphate and/or calcium sulphate as the principal uncoloured components. The potassium salt is also permitted. Colour Index No Einecs Chemical name 42051 222-573-8 The calcium or sodium compound of [4-(-(4-diethylaminophenyl)-5hydroxy-2,4-disulfophenyl-methylidene) 2,5-cyclohexadien-1-ylidene] diethyl-ammonium hydroxide inner salt Calcium compound: C27H31N2O7S2Ca1/2 Sodium compound: C27H31N2O7S2Na Molecular weight Calcium compound: 579,72 Sodium compound: 582,67
Chemical formula
L 83/20
EN
22.3.2012
Assay
Content not less than 85 % total colouring matters, calculated as the sodium salt E1% 1cm 2 000 at ca. 638 nm in aqueous solution at pH 5
Dark blue powder or granules Blue
Maximum in water at 638 nm at pH 5
3-hydroxy benzaldehyde 3-hydroxy benzoic acid 3-hydroxy-4-sulfobenzoic acid N,N-diethylamino benzene sulfonic acid Leuco base Unsulfonated primary aromatic amines Ether extractable matter Arsenic Lead Mercury Cadmium Aluminium lakes of this colour may be used.
9 > > > > > > > > > > > > > = > > > > > > > > > > > > > ;
Not more than 4,0 % Not more than 0,01 % (calculated as aniline) From a solution of pH 5 not more than 0,2 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 132 INDIGOTINE, INDIGO CARMINE Synonyms Definition CI Food Blue 1 Indigotine consists essentially of a mixture of disodium 3,3dioxo-2,2bi-indolylidene-5,5-disulfonate, and disodium 3,3-dioxo-2,2-bi-indo lylidene-5,7-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.
22.3.2012
EN
L 83/21
Indigotine is described as the sodium salt. The calcium and the potassium salt are also permitted. Indigo carmine is obtained by sulphonation of indigo. This is accom plished by heating indigo (or indigo paste) in the presence of sulphuric acid. The dye is isolated and subjected to purification procedures. Colour Index No Einecs Chemical name Chemical formula Molecular weight Assay 73015 212-728-8 Disodium 3,3-dioxo-2,2-bi-indolylidene-5,5-disulfonate C16H8N2Na2O8S2 466,36 Content not less than 85 % total colouring matters, calculated as the sodium salt; disodium 3,3-dioxo-2,2-bi-indolylidene-5,7-disulfonate: not more than 18 % E1% 1cm 480 at ca. 610 nm in aqueous solution Description Appearance of the aqueous solution Identification Spectrometry Purity Water insoluble matter Subsidiary colouring matters Not more than 0,2 % Excluding disodium 3,3-dioxo-2,2-bi-indolylidene-5,7-disulfonate: not more than 1,0 % than 9 > > > > > > > = > > > > > > > ; Maximum in water at ca. 610 nm Dark-blue powder or granules Blue
Organic compounds colouring matters:
other
Isatin-5-sulfonic acid 5-sulfoanthranilic acid Anthranilic acid Unsulfonated primary aromatic amines Ether extractable matter Arsenic Lead
Not more than 3 mg/kg Not more than 2 mg/kg
L 83/22
EN
22.3.2012
Mercury Cadmium Aluminium lakes of this colour may be used.
E 133 BRILLIANT BLUE FCF Synonyms Definition CI Food Blue 2 Brilliant Blue FCF consists essentially of disodium -(4-(N-ethyl-3sulfonatobenzylamino) phenyl)--(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate and its isomers and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Brilliant Blue FCF is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No Einecs Chemical name 42090 223-339-8 Disodium -(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)--(4-N-ethyl3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2sulfonate C37H34N2Na2O9S3 792,84 Content not less than 85 % total colouring matters, calculated as the sodium salt E1% 1cm 1 630 at ca. 630 nm in aqueous solution Description Appearance of the aqueous solution Identification Spectrometry Purity Water insoluble matter Subsidiary colouring matters Organic compounds colouring matters: other than Not more than 0,2 % Not more than 6,0 % Maximum in water at ca. 630 nm Reddish-blue powder or granules Blue
Sum of 2-, 3- and 4-formyl benzene sulfonic acids 3-((ethyl)(4-sulfophenyl) amino) methyl benzene sulfonic acid Leuco base
Not more than 1,5 %
Not more than 0,3 %
Not more than 5,0 %
22.3.2012
EN
L 83/23
Unsulfonated primary aromatic amines Ether extractable matter Arsenic Lead Mercury Cadmium Aluminium lakes of this colour may be used.
Not more than 0,01 % (calculated as aniline) Not more than 0,2 % at pH 7 Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 140 (i) CHLOROPHYLLS Synonyms Definition CI Natural Green 3; Magnesium Chlorophyll; Magnesium Phaeophytin Chlorophylls are obtained by solvent extraction of strains of edible plant material, grass, lucerne and nettle. During the subsequent removal of solvent, the naturally present coordinated magnesium may be wholly or partly removed from the chlorophylls to give the corresponding phaeophytins. The principal colouring matters are the phaeophytins and magnesium chlorophylls. The extracted product, from which the solvent has been removed, contains other pigments such as carotenoids as well as oils, fats and waxes derived from the source material. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane. 75810 Chlorophylls: 215-800-7, chlorophyll a: 207-536-6, Chlorophyll b: 208-272-4 The major colouring principles are: Phytyl (132R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18tetramethyl-13-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta [at]porphyrin-17-yl)propionate, (Phaeophytin a), or as the magnesium complex (Chlorophyll a) Phytyl (132R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl2,12,18-trimethyl-13-oxo-3-vinyl-131-132-17,18-tetrahydrocyclo penta[at]-porphyrin-17-yl)propionate, (Pheophytin b), or as the magnesium complex (Chlorophyll b) Chemical formula Chlorophyll a (magnesium complex): C55H72MgN4O5 Chlorophyll a: C55H74N4O5 Chlorophyll b (magnesium complex): C55H70MgN4O6 Chlorophyll b: C55H72N4O6 Molecular weight Chlorophyll a (magnesium complex): 893,51 Chlorophyll a: 871,22 Chlorophyll b (magnesium complex): 907,49 Chlorophyll b: 885,20
Colour Index No Einecs
Chemical name
L 83/24
EN
22.3.2012
Assay
Content of total combined Chlorophylls and their magnesium complexes is not less than 10 % E1% 1cm 700 at ca. 409 nm in chloroform
Description
Waxy solid ranging in colour from olive green to dark green depending on the content of coordinated magnesium
Identification Spectrometry Purity Solvent residues Acetone Methyl Ethyl ketone Methanol Ethanol Propan-2-ol Hexane Dichloromethane: Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg 9 > > > > > > > > > > > > > > > > > > > > > > > > > = Maximum in chloroform at ca. 409 nm
Not more than 50 mg/kg, singly or in combination > > > > > > > > > > > > > > > > > > > > > > > > > ;
E 140 (ii) CHLOROPHYLLINS Synonyms Definition CI Natural Green 5; Sodium Chlorophyllin; Potassium Chlorophyllin The alkali salts of chlorophyllins are obtained by the saponification of a solvent extract of strains of edible plant material, grass, lucerne and nettle. The saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. The acid groups are neutralised to form the salts of potassium and/or sodium. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane. Colour Index No 75815
22.3.2012
EN
L 83/25
287-483-3 The major colouring principles in their acid forms are: 3-(10-carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinyl phorbin-7-yl)propionate (chlorophyllin a) and 3-(10-carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinyl phorbin-7-yl)propionate (chlorophyllin b) Depending on the degree of hydrolysis the cyclopentenyl ring may be cleaved with the resultant production of a third carboxyl function. Magnesium complexes may also be present.
Chemical formula
Chlorophyllin a (acid form): C34H34N4O5 Chlorophyllin b (acid form): C34H32N4O6
Molecular weight
Chlorophyllin a: 578,68 Chlorophyllin b: 592,66 Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved.
Assay
Content of total chlorophyllins is not less than 95 % of the sample dried at ca. 100 C for 1 hour. E1% 1cm 700 at ca. 405 nm in aqueous solution at pH 9 E1% 1cm 140 at ca. 653 nm in aqueous solution at pH 9
Dark green to blue/black powder
Maximum in aqueous phosphate buffer at pH 9 at ca. 405 nm and at ca. 653 nm
Purity Solvent residues Acetone Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane Dichloromethane: Arsenic Lead Not more than 3 mg/kg Not more than 10 mg/kg 9 > > > > > > > > > > > > > > > > > > > > > > > =
not more than 10 mg/kg
Not more than 50 mg/kg, singly or in combination > > > > > > > > > > > > > > > > > > > > > > > ;
L 83/26
EN
22.3.2012
Mercury
Cadmium
E 141 (i) COPPER COMPLEXES OF CHLOROPHYLLS Synonyms CI Natural Green 3; Copper Chlorophyll; Copper Phaeophytin
Definition
Copper chlorophylls are obtained by addition of a salt of copper to the substance obtained by solvent extraction of strains of edible plant material, grass, lucerne, and nettle. The product, from which the solvent has been removed, contains other pigments such as carotenoids as well as fats and waxes derived from the source material. The principal colouring matters are the copper phaeophytins. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.
Colour Index No
75810
Einecs
Copper chlorophyll a: 239-830-5; copper chlorophyll b: 246-020-5
Chemical name
[Phytyl (132R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18tetramethyl-13-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]porphyrin-17-yl)propionate] copper (II) (Copper Chlorophyll a) [Phytyl (132R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl2,12,18-trimethyl-13-oxo-3-vinyl-131-132-17,18-tetrahydrocyclo penta[at]-porphyrin-17-yl)propionate] copper (II) (Copper chlorophyll b)
Chemical formula
Copper chlorophyll a: C55H72Cu N4O5 Copper chlorophyll b: C55H70Cu N4O6
Molecular weight
Copper chlorophyll a: 932,75 Copper chlorophyll b: 946,73
Assay
Content of total copper chlorophylls is not less than 10 %. E1% 1cm 540 at ca. 422 nm in chloroform E1% 1cm 300 at ca. 652 nm in chloroform
Description
Waxy solid ranging in colour from blue green to dark green depending on the source material
Identification
Spectrometry
Maximum in chloroform at ca. 422 nm and at ca. 652 nm
22.3.2012
EN
L 83/27
Purity Solvent residues Acetone Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane Dichloromethane: Arsenic Lead Mercury Cadmium Copper ions Total copper Aluminium lakes of this colour may be used. Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 200 mg/kg Not more than 8,0 % of the total copper phaeophytins 9 > > > > > > > > > > > > > > > > > > > > > > =
Not more than 50 mg/kg, singly or in combination > > > > > > > > > > > > > > > > > > > > > > ;
E 141 (ii) COPPER COMPLEXES OF CHLOROPHYLLINS Synonyms Sodium Copper Chlorophyllin; Potassium Copper Chlorophyllin; CI Natural Green 5 The alkali salts of copper chlorophyllins are obtained by the addition of copper to the product obtained by the saponification of a solvent extraction of strains of edible plant material, grass, lucerne, and nettle; the saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. After addition of copper to the purified chlorophyllins, the acid groups are neutralised to form the salts of potassium and/or sodium. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide methanol, ethanol, propan-2-ol and hexane. Colour Index No Einecs Chemical name The major colouring principles in their acid forms are 3-(10Carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7yl)propionate, copper complex (Copper chlorophyllin a) and 3-(10Carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7yl) propionate, copper complex (Copper chlorophyllin b) 75815
Definition
L 83/28
EN
22.3.2012
Chemical formula
Copper chlorophyllin a (acid form): C34H32Cu N4O5 Copper chlorophyllin b (acid form): C34H30Cu N4O6
Molecular weight
Copper chlorophyllin a: 640,20 Copper chlorophyllin b: 654,18 Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved.
Assay
Content of total copper chlorophyllins is not less than 95 % of the sample dried at 100 C for 1 h. E1% 1cm 565 at ca. 405 nm in aqueous phosphate buffer at pH 7,5 E1% 1cm 145 at ca. 630 nm in aqueous phosphate buffer at pH 7,5
Dark green to blue/black powder
Maximum in aqueous phosphate buffer at pH 7,5 at ca. 405 nm and at 630 nm
Purity Solvent residues Acetone Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane Dichloromethane: Arsenic Lead Mercury Cadmium Copper ions Total copper Aluminium lakes of this colour may be used. Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 200 mg/kg Not more than 8,0 % of the total copper chlorophyllins 9 > > > > > > > > > > > > > > > > > > > > > > > > > =
22.3.2012
EN
L 83/29
E 142 GREEN S Synonyms Definition CI Food Green 4, Brilliant Green BS Green S consists essentially of sodium N-[4-[[4-(dimethylamino)phenyl] 2-hydroxy-3,6-disulfo-1-naphthalenyl)methylene]-2,5-cyclohexadien-1ylidene]-N-methylmethanaminium and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured compounds. Green S is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No Einecs Chemical name 44090 221-409-2 Sodium N-[4-[[4-(dimethylamino)phenyl](2-hydroxy-3,6-disulfo-1naphthalenyl)-methylene]2,5-cyclohexadien-1-ylidene]-N-methylmetha naminium; Sodium 5-[4-dimethylamino--(4-dimethyliminocyclohexa2,5-dienylidene) benzyl]-6-hydroxy-7-sulfonato-naphthalene-2sulfonate (alternative chemical name). C27H25N2NaO7S2 576,63 Content not less than 80 % total colouring matters calculated as the sodium salt E1% 1cm 1 720 at ca. 632 nm in aqueous solution Description Appearance of the aqueous solution Identification Spectrometry Purity Water insoluble matter Subsidiary colouring matters Organic compounds colouring matters: other than Not more than 0,2 % Not more than 1,0 % Maximum in water at ca. 632 nm Dark blue or dark green powder or granules Blue or green
4,4-bis(dimethylamino)-benz hydryl alcohol 4,4-bis(dimethylamino)-benzop henone 3-hydroxynaphthalene-2,7disulfonic acid Leuco base
Not more than 0,1 %
Not more than 0,1 %
Not more than 0,2 %
Not more than 5,0 %
L 83/30
EN
22.3.2012
Unsulfonated primary aromatic amines Ether extractable matter Arsenic Lead Mercury Cadmium Aluminium lakes of this colour may be used.
Not more than 0,01 % (calculated as aniline) Not more than 0,2 % under neutral conditions Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 150a PLAIN CARAMEL Synonyms Definition Caustic caramel Plain caramel is prepared by the controlled heat treatment of carbohy drates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose). To promote caramelisation, acids, alkalis and salts may be employed, with the exception of ammonium compounds and sulphites.
Colour Index No Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Purity Colour bound by DEAE cellulose Colour bound by phosphoryl cellulose Colour intensity (1) Total nitrogen _____________
(1) Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm.
232-435-9
Dark brown to black liquids or solids
Not more than 50 % Not more than 50 % 0,01-0,12 Not more than 0,1 %
22.3.2012
EN
L 83/31
Total sulphur Arsenic Lead Mercury Cadmium
Not more than 0,2 % Not more than 1 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 150b CAUSTIC SULPHITE CARAMEL Synonyms Definition Caustic sulphite caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of sulphite compounds (sul phurous acid, potassium sulphite, potassium bisulphite, sodium sulphite and sodium bisulphite); no ammonium compounds are used.
Colour Index No Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Purity Colour bound by DEAE cellulose Colour intensity (1) Total nitrogen Sulphur dioxide Total sulphur _____________
(1) Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm. (2) Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units.
232-435-9
More than 50 % 0,05-0,13 Not more than 0,3 % (2) Not more than 0,2 % (2) 0,3-3,5 % (2)
L 83/32
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22.3.2012
Sulphur bound by DEAE cellulose Absorbance ratio of colour bound by DEAE cellulose Absorbance ratio (A Arsenic Lead Mercury Cadmium
280/560)
More than 40 % 19-34
Greater than 50 Not more than 1 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 150c AMMONIA CARAMEL Synonyms Definition Ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of ammonium compounds (ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate and ammonium phosphate); no sulphite compounds are used.
Colour Index No Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Purity Colour bound by DEAE cellulose Colour bound by phosphoryl cellulose Colour intensity (1) Ammoniacal nitrogen _____________
232-435-9
Not more than 50 % More than 50 % 0,08-0,36 Not more than 0,3 % (2)
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4-methylimidazole 2-acetyl-4-tetrahydroxy-butylimidazole Total sulphur Total nitrogen Absorbance ratio of colour bound by phosphoryl cellulose Arsenic Lead Mercury Cadmium
Not more than 200 mg/kg (2) Not more than 10 mg/kg (2) Not more than 0,2 % (2) 0,7-3,3 % (2) 13-35
E 150d SULPHITE AMMONIA CARAMEL Synonyms Definition Sulphite ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive swee teners which are the monomers glucose and fructose and/or polymers thereof (e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis in the presence of both sulphite and ammonium compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite, sodium bisulphite, ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate, ammonium phosphate, ammonium sulphate, ammonium sulphite and ammonium hydrogen sulphite).
Colour Index No Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Purity Colour bound by DEAE cellulose Colour intensity (1) Ammoniacal nitrogen _____________
232-435-9
More than 50 % 0,10-0,60 Not more than 0,6 % (2)
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Sulphur dioxide 4-methylimidazole Total nitrogen Total sulphur Nitrogen/sulphur precipitate ratio of alcohol
Not more than 0,2 % (2) Not more than 250 mg/kg (2) 0,3-1,7 % (2) 0,8-2,5 % (2) 0,7-2,7
Absorbance ratio of alcohol precipi tate (1) Absorbance ratio (A Arsenic Lead Mercury Cadmium
280/560)
8-14
Not more than 50 Not more than 1 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 151 BRILLIANT BLACK BN, BLACK PN Synonyms Definition CI Food Black 1 Brilliant Black BN consists essentially of tetrasodium-4-acetamido-5hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naph thalene-1,7-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Brilliant Black BN is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No Einecs Chemical name 28440 219-746-5 Tetrasodium 4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatop henylazo)-1-naphthylazo] naphthalene-1,7-disulfonate C28H17N5Na4O14S4 867,69 Content not less than 80 % total colouring matters calculated as the sodium salt E1% 1cm 530 at ca. 570 nm in solution Description Appearance of the aqueous solution _____________
(1) Absorbance ratio of alcohol precipitate is defined as the absorbance of the precipitate at 280 nm divided by the absorbance at 560 nm (1 cm cell). (2) Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units.
Black powder or granules Black-bluish
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Identification Spectrometry Purity Water insoluble matter Subsidiary colouring matters Organic compounds colouring matters: other than 9 > > > > > > > > > > > > > > > > > > = > > > > > > > > > > > > > > > > > > ; Not more than 0,2 % Not more than 4 % (expressed on the dye content) Maximum in water at ca. 570 nm
4-acetamido-5-hydroxynaph thalene-1,7-disulfonic acid 4-amino-5-hydroxynaphthalene1,7-disulfonic acid 8-aminonaphthalene-2-sulfonic acid 4,4-diazoaminodi-(benzene sulfonic acid) Unsulfonated primary aromatic amines Ether extractable matter Arsenic Lead Mercury Cadmium Aluminium lakes of this colour may be used.
E 153 VEGETABLE CARBON Synonyms Definition Vegetable black Vegetable activated carbon is produced by the carbonisation of vegetable material such as wood, cellulose residues, peat and coconut and other shells. The activated carbon thus produced is milled by a roller mill and the resulting highly activated powdered carbon is treated by a cyclone. The fine fractio40800n from the cyclone is purified by hydrochloric acid washing, neutralised and then dried. The resulting product is what is known traditionally as vegetable black. Products with a higher colouring power are produced from the fine fraction by a further cyclone treatment or by extra milling, followed by acid washing, neutralising and drying. It consists essentially of finely divided carbon. It may contain minor amounts of nitrogen, hydrogen and oxygen. Some moisture may be absorbed on the product after manu facture. 77266 231-153-3
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Chemical name Chemical formula Atomic weight Assay
Carbon C 12,01 Content not less than 95 % of carbon calculated on an anhydrous and ash-free basis Not more than 12 % (120 C 4 h) Black, odourless powder
Loss on drying Description Identification Solubility Burning Purity Ash (Total) Arsenic Lead Mercury Cadmium Polycyclic aromatic hydrocarbons
Insoluble in water and organic solvents When heated to redness it burns slowly without a flame
Not more than 4,0 % (ignition temperature: 625 C) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Benzo(a)pyrene less than 50 g/kg in the extract obtained by extraction of 1 g of the product with 10 g pure cyclohexane in a continuous extraction. The filtrate obtained by boiling 2 g of the sample with 20 ml N sodium hydroxide and filtering shall be colourless
Alkali soluble matter
E 155 BROWN HT Synonyms Definition CI Food Brown 3 Brown HT consists essentially of disodium 4,4-(2,4-dihydroxy-5hydroxymethyl-1,3-phenylene bisazo) di (naphthalene-1-sulfonate) and subsidiary colouring matters together with sodium chloride and/or sulphate as the principal uncoloured components. Brown HT is described as the sodium salt. The calcium and potassium salt are also permitted. Colour Index No Einecs Chemical name 20285 224-924-0 Disodium 4,4-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo)di (naphthalene-1-sulfonate)
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C27H18N4Na2O9S2 652,57 Content not less than 70 % total colouring matters calculated as the sodium salt. E1% 1cm 403 at ca. 460 nm in aqueous solution at pH 7
Reddish-brown powder or granules Brown
Maximum in water of pH 7 at ca. 460 nm
Not more than 0,2 % Not more than 10 % (TLC method)
4-aminonaphthalene- 1-sulfonic acid Unsulfonated primary aromatic amines Ether extractable matter Arsenic Lead Mercury Cadmium Aluminium lakes of this colour may be used.
Not more than 0,7 %
Not more than 0,01 % (calculated as aniline)
Not more than 0,2 % in a solution of pH 7 Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 160 a (i) BETA-CAROTENE Synonyms Definition CI Food Orange 5 These specifications apply predominantly to all trans isomer of betacarotene together with minor amounts of other carotenoids. Diluted and stabilised preparations may have different trans-cis isomer ratios. 40800 230-636-6 Beta-carotene; beta, beta-carotene
Colour Index No Einecs Chemical name
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C40H56 536,88 Not less than 96 % total colouring matters (expressed as beta-carotene) E1% 1cm 2 500 at approximately by 440 nm to 457 nm in cyclohexane
Description Identification Spectrometry Purity Sulphated ash Subsidiary colouring matters
Red to brownish-red crystals or crystalline powder
Maximum in cyclohexane at 453 nm to 456 nm
Not more than 0,1 % Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters Not more than 2 mg/kg
Lead
E 160 a (ii) PLANT CAROTENES Synonyms Definition CI Food Orange 5 Plant carotenes are obtained by solvent extraction of strains of edible plants, carrots, vegetable oils, grass, alfalfa (lucerne) and nettle. The main colouring principle consists of carotenoids of which betacarotene accounts for the major part. Alpha, gamma-carotene and other pigments may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material. Only the following solvents may be used in the extraction: acetone, methyl ethyl ketone, methanol, ethanol, propan-2-ol, hexane (1), dichloromethane and carbon dioxide. Colour Index No Einecs Chemical name Chemical formula Molecular weight Assay Beta-carotene: C40H56 Beta-carotene: 536,88 Content of carotenes (calculated as beta-carotene) is not less than 5 %. For products obtained by extraction of vegetables oils: not less than 0,2 % in edible fats E1% 1cm 2 500 at approximately 440 nm to 457 nm in cyclohexane _____________
(1) Benzene not more than 0,05 % v/v.
75130 230-636-6
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Description Identification Spectrometry Maximum in cyclohexane at 440 nm to 457 nm and 470 nm to 486 nm
Purity Solvent residues Acetone Methyl ethyl ketone Methanol Propan-2-ol Hexane Ethanol Dichloromethane Lead Not more than 2 mg/kg 9 > > > > > > > > > > > > > > > > > > > > =
Not more than 50 mg/kg, singly or in combination > > > > > > > > > > > > > > > > > > > > ;
E 160 a (iii) BETA-CAROTENE FROM Blakeslea trispora Synonyms Definition CI Food Orange 5 Obtained by a fermentation process using a mixed culture of the two sexual mating types (+) and () of strains of the fungus Blakeslea trispora. The beta-carotene is extracted from the biomass with ethyl acetate or isobutyl acetate followed by propan-2-ol and crystallised. The crystallised product consists mainly of trans beta-carotene. Because of the natural process approximately 3 % of the product consists of mixed carotenoids, which is specific for the product. 40800 230-636-6 Beta-carotene; beta, beta-carotene C40H56 536,88 Not less than 96 % total colouring matters (expressed as betacarotene) E1% 1cm 2 500 at approximately 440 nm to 457 nm in cyclohexane Description Red, brownish-red or purple-violet crystals or crystalline powder (colour varies according to extraction solvent used and conditions of crystallisation)
Colour Index No Einecs Chemical name Chemical formula Molecular weight Assay
Identification Spectrometry Maximum in cyclohexane at 453 nm to 456 nm
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Purity Solvent residues Ethyl acetate Ethanol 9 > =
Isobutyl acetate: Not more than 1,0 % Propan-2-ol: Not more than 0,1 % Sulphated ash Subsidiary colouring matters Not more than 0,2 %
Not more than 0,8 %, singly or in combination > ;
Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters Not more than 2 mg/kg
Lead Microbiological criteria Moulds Yeasts Salmonella spp. Escherichia coli
Not more than 100 colonies per gram Not more than 100 colonies per gram Absent in 25 g Absent in 5 g
E 160 a (iv) ALGAL CAROTENES Synonyms Definition CI Food Orange 5 Mixed carotenes may also be produced from strains of the algae Duna liella salina, grown in large saline lakes located in Whyalla, South Australia. Beta-carotene is extracted using an essential oil. The prep aration is a 20 to 30 % suspension in edible oil. The ratio of trans-cis isomers is in the range of 50/50 to 71/29. The main colouring principle consists of carotenoids of which betacarotene accounts for the major part. Alpha-carotene, lutein, zeax anthin and beta-cryptoxanthin may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material. Colour Index No Einecs Chemical name Chemical formula Molecular weight Assay Beta-Carotene: C40H56 Beta-Carotene: 536,88 Content of carotenes (calculated as beta-carotene) is not less than 20 % E1% 1cm 2 500 at approximately by 440 nm to 457 nm in cyclohexane 75130
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Description Identification Spectrometry Maximum in cyclohexane at 440 nm to 457 nm and 474 nm to 486 nm
Purity Natural tocopherols in edible oil Lead Not more than 0,3 % Not more than 2 mg/kg
E 160 b ANNATTO, BIXIN, NORBIXIN (i) SOLVENT-EXTRACTED BIXIN AND NORBIXIN Synonyms Definition CI Natural Orange 4 Bixin is prepared by the extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with one or more of the following solvents: acetone, methanol, hexane or dichloromethane, carbon dioxide followed by the removal of the solvent. Norbixin is prepared by hydrolysis by aqueous alkali of the extracted bixin. Bixin and norbixin may contain other materials extracted from the annatto seed. The bixin powder contains several coloured components, the major single one being bixin, which may be present in both cis- and transforms. Thermal degradation products of bixin may also be present. The norbixin powder contains the hydrolysis product of bixin, in the form of the sodium or potassium salts as the major colouring prin ciple. Both cis- and trans-forms may be present. Colour Index No Einecs 75120 Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7 8 6-Methylhydrogen-9-cis-6,6> > > > > < diapocarotene-6,6-dioate > > > > 6-Methylhydrogen-9-trans> : 6,6-diapocarotene-6,6-dioate
Chemical name Bixin:
Norbixin:
8 9cis-6,6-Diapocarotene-6,6> > > > > < dioic acid > > > > 9-trans-6,6-Diapocarotene> : 6,6-dioic acid C25H30O4 C24H28O4
Chemical formula
Bixin: Norbixin:
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Molecular weight
Bixin: Norbixin:
394,51 380,48
Assay
Content of bixin powders not less than 75 % total carotenoids calculated as bixin. Content of norbixin powders not less than 25 % total carotenoids calculated as norbixin Bixin: E1% 1cm 2 870 at ca. 502 nm in chloroform E1% 1cm 2 870 at ca. 482 nm in KOH solution
Norbixin:
Reddish-brown powder, suspension or solution
Bixin:
maximum in chloroform at ca. 502 nm maximum in dilute solution at ca. 482 nm KOH
Norbixin:
Purity Solvent residues Acetone Methanol Hexane Dichloromethane: Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg 9 > > > > > > > =
not more than 50 mg/kg, singly or in combination > > > > > > > ;
(ii) ALKALI EXTRACTED ANNATTO Synonyms Definition CI Natural Orange 4 Water soluble annatto is prepared by extraction with aqueous alkali (sodium or potassium hydroxide) of the outer coating of the seeds of the annatto tree (Bixa orellana L.) Water soluble annatto contains norbixin, the hydrolysis product of bixin, in the form of the sodium or potassium salts, as the major colouring principle. Both cis- and trans- forms may be present.
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75120 Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7 8 6-Methylhydrogen-9-trans> > > > < 6,6-diapocarotene-6,6-dioate 8 9cis-6,6-Diapocarotene-6,6> > > > < dioic acid
> > > 6-Methylhydrogen-9-trans> : 6,6-diapocarotene-6,6-dioate
Norbixin:
Chemical formula
Bixin: Norbixin:
> > > 6-Methylhydrogen-9-trans> : 6,6-diapocarotene-6,6-dioate C25H30O4 C24H28O4 394,51 380,48
Molecular weight
Bixin: Norbixin:
Assay
Contains not less than 0,1 % of total carotenoids expressed as norbixin Norbixin: E1% 1cm 2 870 at ca. 482 nm in KOH solution
Bixin:
Norbixin:
Purity Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
(iii) OIL EXTRACTED ANNATTO Synonyms Definition CI Natural Orange 4 Annatto extracts in oil, as solution or suspension, are prepared by extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with edible vegetable oil. Annatto extract in oil contains several coloured components, the major single one being bixin, which may be present in both cis- and trans-forms. Thermal degradation products of bixin may also be present.
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75120 Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7 8 6-Methylhydrogen-9-cis-6,6> > > > < diapocarotene-6,6-dioate 8 9cis-6,6-Diapocarotene-6,6> > > > < dioic acid > > > 9-trans-6,6-Diapocarotene> : 6,6-dioic acid C25H30O4 C24H28O4 394,51 380,48 > > > 6-Methylhydrogen-9-trans> : 6,6-diapocarotene-6,6-dioate
Norbixin:
Chemical formula
Bixin: Norbixin:
Molecular weight
Bixin: Norbixin:
Assay
Contains not less than 0,1 % of total carotenoids expressed as bixin Bixin: E1% 1cm 2 870 at ca. 502 nm in chloroform
Bixin:
Norbixin:
Purity Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 160 c PAPRIKA EXTRACT, CAPSANTHIN, CAPSORUBIN Synonyms Definition Paprika Oleoresin Paprika extract is obtained by solvent extraction of the strains of paprika, which consists of the ground fruits pods, with or without seeds, of Capsicum annuum L., and contains the major colouring prin ciples of this spice. The major colouring principles are capsanthin and capsorubin. A wide variety of other coloured compounds is known to be present.
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Only the following solvents may be used in the extraction: methanol, ethanol, acetone, hexane, dichloromethane, ethyl acetate, propan-2-ol and carbon dioxide. Colour Index No Einecs Chemical name Capsanthin: 207-364-1, capsorubin: 207-425-2 Capsanthin: (3R, 3S, 5R)-3,3-dihydroxy-,-carotene-6-one Capsorubin: (3S, 3S, 5R, 5R)-3,3-dihydroxy-,-carotene-6,6-dione Chemical formula Capsanthin: Capsorubin: Molecular weight Capsanthin: Capsorubin: Assay C40H56O3 C40H56O4 584,85 600,85
Paprika extract: content not less than 7,0 % carotenoids Capsanthin/capsorubin: not less than 30 % of total carotenoids E1% 1cm 2 100 at ca. 462 nm in acetone
Description Identification Spectrometry Colour reaction
Dark-red viscous liquid
Maximum in acetone at ca. 462 nm A deep blue colour is produced by adding one drop of sulphuric acid to one drop of sample in 2-3 drops of chloroform
Purity Solvent residues Ethyl acetate Methanol Ethanol Acetone Hexane Propan-2-ol Dichloromethane: Capsaicin Not more than 250 mg/kg 9 > > > > > > > > > > > > > > > > > > > > > > > > > =
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Arsenic Lead Mercury Cadmium
E 160 d LYCOPENE (i) SYNTHETIC LYCOPENE Synonyms Definition Lycopene from chemical synthesis Synthetic lycopene is a mixture of geometric isomeres of lycopenes and is produced by the Wittig condensation of synthetic intermediates commonly used in the production of other carotenoids used in food. Synthetic lycopene consists predominantly of all-trans-lycopene together with 5-cis-lycopene and minor quantities of other isomers. Commercial lycopene preparations intended for use in food are formulated as suspensions in edible oils or water-dispersible or water-soluble powder. 75125 207-949-1 ,-carotene, all-trans-lycopene, (all-E)-lycopene, (all-E)2,6,10,14,19,23,27,31-octamethyl2,6,8,10,12,14,16,18,20,22,24,26,30-dotriacontatridecaene C40H56 536,85 Not less than 96 % total lycopenes (not less than 70 % all-translycopene) E1% 1cm at 465-475 nm in hexane (for 100 % pure all-trans-lycopene) is 3 450 Description Identification Spectrophotometry A solution in hexane shows an absorption maximum at approximately 470 nm The colour of the solution of the sample in acetone disappears after successive additions of a 5 % solution of sodium nitrite and 1N sulphuric acid Insoluble in water, freely soluble in chloroform 1% solution in Is clear and has intensive red-orange colour Red crystalline powder
Test for carotenoids
Solubility Properties of chloroform
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Purity Loss on drying Apo-12-lycopenal Triphenyl phosphine oxide Solvent residues Not more than 0,5 % (40 C, 4 h at 20 mm Hg) Not more than 0,15 % Not more than 0,01 % Methanol not more than 200 mg/kg, Hexane, Propan-2-ol: Not more than 10 mg/kg each. Dichloromethane: Not more than 10 mg/kg (in commercial prep arations only) Lead Not more than 1 mg/kg
(ii) LYCOPENE FROM RED TOMATOES Synonyms Definition Natural Yellow 27 Lycopene is obtained by solvent extraction of red tomatoes (Lyco persicon esculentum L.) with subsequent removal of the solvent. Only the following solvent may be used: carbon dioxide, ethyl acetate, acetone, propan-2-ol, methanol, ethanol and hexane. The major colouring principle of tomatoes is lycopene; minor amounts of other carotenoid pigments may be present. Besides the colour pigments the product may contain oil, fats, waxes and flavour components naturally occurring in tomatoes. 75125 207-949-1 ,-carotene, all-trans-lycopene, (all-E)-lycopene, (all-E)2,6,10,14,19,23,27,31-octamethyl2,6,8,10,12,14,16,18,20,22,24,26,30-dotriacontatridecaene C40H56 536,85 E1% 1cm at 465-475 nm in hexane (for 100 % pure all-trans-lycopene) is 3 450. Content not less than 5 % total colouring matters Description Identification Spectrophotometry Maximum in hexane at ca. 472 nm Dark red viscous liquid
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Purity Solvent residues Propan-2-ol Hexane Acetone Ethanol Methanol Ethylacetate Sulphated ash Mercury Cadmium Arsenic Lead Not more than 1 % Not more than 1 mg/kg Not more than 1 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg 9 > > > > > > > > > > > > > > > > > > > > > > =
Not more than 50 mg/kg, singly or in combination > > > > > > > > > > > > > > > > > > > > > > > ;
(iii) LYCOPENE FROM BLAKESLEA TRISPORA Synonyms Definition Natural Yellow 27 Lycopene from Blakeslea trispora is extracted from the fungal biomass and purified by crystallisation and filtration. It consists predominantly of all-trans-lycopene. It also contains minor quantities of other carote noids. Propan-2-ol and isobutyl acetate are the only solvents used in the manufacture. Commercial lycopene preparations intended for use in food are formulated as suspensions in edible oils or water-dispersible or water-soluble powder. 75125 207-949-1 ,-carotene, all-trans-lycopene, (all-E)-lycopene, ((all-E)2,6,10,14,19,23,27,31-octamethyl2,6,8,10,12,14,16,18,20,22,24,26,30-dotriacontatridecaene C40H56 536,85 Not less than 95 % total lycopenes and not less than 90 % all-translycopene of all colouring matters E1% 1cm at 465-475 nm in hexane (for 100 % pure all-trans-lycopene) is 3 450 Description Red crystalline powder
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Identification Spectrophotometry A solution in hexane shows an absorption maximum at approximately 470 nm The colour of the solution of the sample in acetone disappears after successive additions of a 5 % solution of sodium nitrite and 1N sulphuric acid Insoluble in water, freely soluble in chloroform 1% solution in Is clear and has intensive red-orange colour
Test of carotenoids
Solubility Properties of chloroform Purity Loss on drying Other carotenoids Solvent residues
Not more than 0,5 % (40 C, 4 h at 20 mm Hg) Not more than 5 % Propan-2-ol: not more than 0,1 % Isobutyl acetate: not more than 1,0 % Dichloromethane: not more than 10 mg/kg (in commercial prep arations only)
Sulphated ash Lead
Not more than 0,3 % Not more than 1 mg/kg
E 160 e BETA-APO-8-CAROTENAL (C30) Synonyms Definition CI Food Orange 6 These specifications apply predominantly to the all-trans isomer of apo-8-carotenal together with minor amounts of other carotenoids. Diluted and stabilised forms are prepared from -apo-8-carotenal meeting these specifications and include solutions or suspensions of -apo-8carotenal in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios. 40820 214-171-6 -Apo-8-carotenal; trans--Apo-8carotene-aldehyde C30H40O 416,65 Not less than 96 % of total colouring matters E1% 1cm 2 640 at 460-462 nm in cyclohexane Description Dark violet crystals with metallic lustre or crystalline powder
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Identification Spectrometry Purity Sulphated ash Subsidiary colouring matters Not more than 0,1 % Carotenoids other than -apo-8-carotenal: not more than 3,0 % of total colouring matters Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Maximum in cyclohexane at 460-462 nm
E 161 b LUTEIN Synonyms Definition Mixed Carotenoids; Xanthophylls Lutein is obtained by solvent extraction of the strains of edible fruits and plants, grass, lucerne (alfalfa) and Tagetes erecta. The main colouring principle consists of carotenoids of which lutein and its fatty acid esters account for the major part. Variable amounts of carotenes will also be present. Lutein may contain fats, oils and waxes naturally occurring in the plant material. Only the following solvents may be used for the extraction: methanol, ethanol, propan-2-ol, hexane, acetone, methyl ethyl ketone and carbon dioxide Colour Index No Einecs Chemical name Chemical formula Molecular weight Assay 204-840-0 3,3-dihydroxy-d-carotene C40H56O2 568,88 Content of total colouring matter not less than 4 % calculated as lutein E1% 1cm 2 550 at ca. 445 nm in chloroform/ethanol (10 + 90) or in hexane/ethanol/acetone (80 + 10 + 10) Description Identification Spectrometry Maximum in chloroform/ethanol (1:9) at ca. 445 nm Dark, yellowish brown liquid
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Purity Solvent residues Acetone Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 3 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg 9 > > > > > > > > > > > > > > > > > > > > > > =
Not more than 50 mg/kg, singly or in combination > > > > > > > > > > > > > > > > > > > > > > ;
E 161g CANTHAXANTHIN Synonyms Definition CI Food Orange 8 These specifications apply to predominantly all-trans isomers of canthaxanthin together with minor amounts of other carotenoids. Diluted and stabilised forms are prepared from canthaxanthin meeting these specifications and include solutions or suspensions of canthaxanthin in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios. 40850 208-187-2 -Carotene-4,4-dione; canthaxanthin; 4,4-dioxo--carotene C40H52O2 564,86 Not less than 96 % of total colouring matters (expressed as canthax anthin) 8 at ca. 485 nm in chloroform > > > > > > > > < at 468-472 nm in cyclohexane > > > > > > > at 464-467 nm in petroleum > : ether
E1% 1cm 2 200
Description
Deep violet crystals or crystalline powder
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Identification Spectrometry Maximum in chloroform at ca. 485 nm Maximum in cyclohexane at 468-472 nm Maximum in petroleum ether at 464-467 nm Purity Sulphated ash Subsidiary colouring matters Not more than 0,1 % Carotenoids other than canthaxanthin: not more than 5,0 % of total colouring matters Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 162 BEETROOT RED, BETANIN Synonyms Definition Beet Red Beet red is obtained from the roots of strains of red beets (Beta vulgaris L. var. rubra) by pressing crushed beet as press juice or by aqueous extraction of shredded beet roots and subsequent enrichment in the active principle. The colour is composed of different pigments all belonging to the class betalaine. The main colouring principle consists of betacyanins (red) of which betanin accounts for 75-95 %. Minor amounts of betaxanthin (yellow) and degradation products of betalaines (light brown) may be present. Besides the colour pigments the juice or extract consists of sugars, salts, and/or proteins naturally occurring in red beets. The solution may be concentrated and some products may be refined in order to remove most of the sugars, salts and proteins. Colour Index No Einecs Chemical name 231-628-5 (S-(R,R)-4-(2-(2-Carboxy-5(-D-glucopyranosyloxy)-2,3-dihydro-6hydroxy-1H-indol-1-yl)ethenyl)-2,3-dihydro-2,6-pyridine-dicarboxylic acid; 1-(2-(2,6-dicarboxy-1,2,3,4-tetrahydro-4-pyridylidene)ethylidene)5--D-glucopyranosyloxy)-6-hydroxyindolium-2-carboxylate Betanin: C24H26N2O13 550,48 Content of red colour (expressed as betanine) is not less than 0,4 % E1% 1cm 1 120 at ca. 535 nm in aqueous solution at pH 5 Description Red or dark red liquid, paste, powder or solid
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Identification Spectrometry Purity Nitrate Not more than 2 g nitrate anion/g of red colour (as calculated from assay). Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Maximum in water of pH 5 at ca. 535 nm
E 163 ANTHOCYANINS Synonyms Definition Anthocyanins are obtained by maceration or extraction with sulphited water, acidified water, carbon dioxide, methanol or ethanol from the strains of vegetables and edible fruits, with subsequent concentration and/or purification if necessary. The resulting product can be trans formed into powder by an industrial drying process. Anthocyanins contain common components of the source material, namely antho cyanine, organic acids, tannins, sugars, minerals etc., but not necessarily in the same proportions as found in the source material. Ethanol may naturally be present as a result of the maceration process. The colouring principle is anthocyanin. Products are marketed according to their colour strength as determined by the assay. Colour content is not expressed using quantitative units.
Colour Index No Einecs 208-438-6 (cyanidin); 205-125-6 (peonidin); 208-437-0 (del phinidin); 211-403-8 (malvidin); 205-127-7 (pelargonidin); 215-849-4 (petunidin) 3,3,4,5,7-Pentahydroxy-flavylium chloride (cyanidin) 3,4,5,7-Tetrahydroxy-3-methoxyflavylium chloride (peonidin) 3,4,5,7-Tetrahydroxy-3,5-dimethoxyflavylium chloride (malvidin) 3,5,7-Trihydroxy-2-(3,4,5,trihydroxyphenyl)-1-benzopyrylium chloride (delphinidin) 3,34,5,7-Pentahydroxy-5-methoxyflavylium chloride (petunidin) 3,5,7-Trihydroxy-2-(4-hydroxyphenyl)-1-benzopyrilium chloride (pel argonidin) Chemical formula Cyanidin: C15H11O6Cl Peonidin: C16H13O6Cl Malvidin: C17H15O7Cl Delphinidin: C15H11O7Cl
Chemical name
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Petunidin: C16H13O7Cl Pelargonidin: C15H11O5Cl Molecular weight Cyanidin: 322,6 Peonidin: 336,7 Malvidin: 366,7 Delphinidin: 340,6 Petunidin: 352,7 Pelargonidin: 306,7 Assay Description E1% 1cm 300 for the pure pigment at 515-535 nm at pH 3,0 Purplish-red liquid, powder or paste, having a slight characteristic odour
Identification Spectrometry Maximum in methanol with 0,01 % conc. HCl Cyanidin: 535 nm Peonidin: 532 nm Malvidin: 542 nm Delphinidin: 546 nm Petunidin: 543 nm Pelargonidin: 530 nm Purity Solvent residues Methanol Ethanol Sulfur dioxide Arsenic Lead Mercury Cadmium Aluminium lakes of this colour may be used. Not more than 50 mg/kg Not more than 200 mg/kg
Not more than 1 000 mg/kg per percent pigment Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 170 CALCIUM CARBONATE Synonyms Definition CI Pigment White 18; Chalk Calcium carbonate is the product obtained from ground limestone or by the precipitation of calcium ions with carbonate ions.
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77220 Calcium carbonate: 207-439-9 Limestone: 215-279-6
Chemical name Chemical formula Molecular weight Assay Description Identification Solubility
Calcium carbonate CaCO3 100,1 Content not less than 98 % on the anhydrous basis White crystalline or amorphous, odourless and tasteless powder
Practically insoluble in water and in alcohol. Dissolves with effer vescence in diluted acetic acid, in diluted hydrochloric acid and in diluted nitric acid, and the resulting solutions, after boiling, give positive tests for calcium.
Purity Loss on drying Acid-insoluble substances Magnesium and alkali salts Fluoride Antimony (as Sb) Copper (as Cu) Chromium (as Cr) Zinc (as Zn) Barium (as Ba) Arsenic Lead Cadmium Not more than 2,0 % (200 C, 4 hours) Not more than 0,2 % Not more than 1 % Not more than 50 mg/kg 9 > > > > > > > > > > > > > > > > > > > = > > > > > > > > > > > > > > > > > > > ;
Not more than 100 mg/kg, singly or in combination
Not more than 3 mg/kg Not more than 3 mg/kg Not more than 1 mg/kg
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E 171 TITANIUM DIOXIDE Synonyms Definition CI Pigment White 6 Titanium dioxide consists essentially of pure anatase and/or rutile titanium dioxide which may be coated with small amounts of alumina and/or silica to improve the technological properties of the product. The anatase grades of pigmentary titanium dioxide can only be made by the sulphate process which creates a large amount of sulphuric acid as a by-product. The rutile grades of titanium dioxide are typically made by the chloride process. Certain rutile grades of titanium dioxide are produced using mica (also known as potassium aluminum silicate) as a template to form the basic platelet structure. The surface of the mica is coated with titanium dioxide using a specialised patented process. Rutile titanium dioxide, platelet form is manufactured by subjecting titanium dioxide (rutile) coated mica nacreous pigment to an extractive dissolution in acid followed by an extractive dissolution in alkali. All of the mica is removed during this process and the resulting product is a platelet form of rutile titanium dioxide. Colour Index No Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Insoluble in water and organic solvents. Dissolves slowly in hydro fluoric acid and in hot concentrated sulphuric acid. 77891 236-675-5 Titanium dioxide TiO2 79,88 Content not less than 99 % on an alumina and silica-free basis White to slightly coloured powder
Purity Loss on drying Loss on ignition Aluminium dioxide oxide and/or silicon Not more than 0,5 % (105 C, 3 hours) Not more than 1,0 % on a volatile matter free basis (800 C) Total not more than 2,0 %
Matter soluble in 0,5 N HCl
Not more than 0,5 % on an alumina and silica-free basis and, in addition, for products containing alumina and/or silica, not more than 1,5 % on the basis of the product as sold. Not more than 0,5 % Not more than 1 mg/kg after an extraction with 0,5 N HCl.
Water soluble matter Cadmium
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Antimony Arsenic Lead Mercury
Not more than 2 mg/kg after an extraction with 0,5 N HCl. Not more than 1 mg/kg after an extraction with 0,5 N HCl. Not more than 10 mg/kg after an extraction with 0,5 N HCl. Not more than 1 mg/kg after an extraction with 0,5 N HCl.
E 172 IRON OXIDES AND IRON HYDROXIDES Synonyms Iron Oxide Yellow: CI Pigment Yellow 42 and 43 Iron Oxide Red: CI Pigment Red 101 and 102 Iron Oxide Black: CI Pigment Black 11 Definition Iron oxides and iron hydroxides are produced synthetically and consist essentially of anhydrous and/or hydrated iron oxides. The range of hues includes yellows, reds, browns and blacks. Food quality iron oxides are primarily distinguished from technical grades by the comparatively low levels of contamination by other metals. This is achieved by the selection and control of the source of the iron and/or by the extent of chemical purification during the manufac turing process. Iron Oxide Yellow: Iron Oxide Red: Iron Oxide Black: Einecs Iron Oxide Yellow: Iron Oxide Red: Iron Oxide Black: Chemical name 77492 77491 77499 257-098-5 215-168-2 235-442-5
Colour Index No
Iron Oxide Yellow: hydrated ferric oxide, hydrated iron (III) oxide Iron Oxide Red: anhydrous ferric oxide, anhydrous iron (III) oxide Iron Oxide Black: ferroso ferric oxide, iron (II, III) oxide
Chemical formula
Iron Oxide Yellow: Iron Oxide Red: Iron Oxide Black:
FeO(OH) H2O Fe2O3 FeO.Fe2O3 FeO(OH) Fe2O3 FeO.Fe2O3
Molecular weight
88,85: 159,70: 231,55:
Assay
Yellow not less than 60 %, red and black not less than 68 % total iron, expressed as iron Powder; yellow, red, brown or black in hue
Description
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Identification Solubility Insoluble in water and in organic solvents Soluble in concentrated mineral acids Purity Water soluble matter Arsenic Cadmium Chromium Copper Lead Mercury Nickel Zinc Not more than 1,0 % Not more than 3 mg/kg Not more than 1 mg/kg Not more than 100 mg/kg Not more than 50 mg/kg Not more than 10 mg/kg Not more than 1 mg/kg Not more than 200 mg/kg Not more than 100 mg/kg 9 > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > = > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > ;
By total dissolution
E 173 ALUMINIUM Synonyms Definition CI Pigment Metal Aluminium powder is composed of finely divided particles of aluminium. The grinding may or may not be carried out in the presence of edible vegetable oils and/or food additive quality fatty acids. It is free from admixture with substances other than edible vegetable oils and/or food additive quality fatty acids. 77000 231-072-3 Aluminium Al 26,98 Not less than 99 % calculated as Al on an oil-free basis A silvery-grey powder or tiny sheets
Colour Index No Einecs Chemical name Chemical formula Atomic weight Assay Description Identification Solubility
Insoluble in water and in organic solvents. Soluble in dilute hydro chloric acid. A sample dissolved in dilute hydrochloric acid passes test
Test for aluminium
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Purity Loss on drying Arsenic Lead Mercury Cadmium Not more than 0,5 % (105 C, to constant weight) Not more than 3 mg/kg Not more than 10 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 174 SILVER Synonyms Definition Colour Index No Einecs Chemical name Chemical formula Atomic weight Assay Description Identification Purity 77820 231-131-3 Silver Ag 107,87 Content not less than 99,5 % Ag Silver-coloured powder or tiny sheets Argentum
E 175 GOLD Synonyms Definition Colour Index No Einecs Chemical name Chemical formula Atomic weight Assay 77480 231-165-9 Gold Au 197,0 Content not less than 90 % Au Pigment Metal 3; Aurum
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Description Identification Purity Silver Copper
Gold-coloured powder or tiny sheets
Not more than 7 % Not more than 4 %
9 > = > ;
After complete dissolution
E 180 LITHOLRUBINE BK Synonyms Definition CI Pigment Red 57; Rubinpigment; Carmine 6B Lithol Rubine BK consists essentially of calcium 3-hydroxy-4-(4-methyl2-sulfonatophenylazo)-2-naphthalenecarboxylate and subsidiary colouring matters together with water, calcium chloride and/or calcium sulphate as the principal uncoloured components. 15850:1 226-109-5 Calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalenecarboxylate C18H12CaN2O6S 424,45 Content not less than 90 % total colouring matters E1% 1cm 200 at ca. 442 nm in dimethylformamide Description Identification Spectrometry Purity Subsidiary colouring matters Organic compounds colouring matters: other than Not more than 0,5 % Maximum in dimethylformamide at ca. 442 nm Red powder
2-Amino-5-methylbenzene sulfonic acid, calcium salt 3-hydroxy-2-naphthalenecar boxylic acid, calcium salt Unsulfonated primary aromatic amines Ether extractable matter Arsenic
Not more than 0,2 %
Not more than 0,4 %
Not more than 0,01 % (expressed as aniline) From a solution of pH 7, not more than 0,2 % Not more than 3 mg/kg
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Lead Mercury Cadmium Aluminium lakes of this colour may be used.
E 200 SORBIC ACID Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description 203-768-7 Sorbic acid; trans, trans-2,4-Hexadienoic acid C6H8O2 112,12 Content not less than 99 % on the anhydrous basis Colourless needles or white free flowing powder, having a slight char acteristic odour and showing no change in colour after heating for 90 minutes at 105 C
Identification Melting range Between 133 C and 135 C, after vacuum drying for four hours in a sulphuric acid desiccator A propan-2-ol solution (1 in 4 000 000) shows absorbance maximum at 254 2 nm Passes test Slightly soluble in water, soluble in ethanol.
Spectrometry
Test for double bonds Solubility Purity Water content Sulphated ash Aldehydes Arsenic Lead Mercury
Not more than 0,5 % (Karl Fischer method) Not more than 0,2 % Not more than 0,1 % (as formaldehyde) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
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E 202 POTASSIUM SORBATE Synonyms Definition Einecs Chemical name 246-376-1 Potassium sorbate; Potassium (E,E)-2,4-hexadienoate; Potassium salt of trans, trans 2,4-hexadienoic acid C6H7O2K 150,22 Content not less than 99 % on the dried basis White crystalline powder showing no change in colour after heating for 90 minutes at 105 C
Chemical formula Molecular weight Assay Description
Identification Melting range for sorbic acid Melting range of sorbic acid isolated by acidification and not recrystallised 133 C to 135 C after vacuum drying in a sulphuric acid desiccator Passes test Passes test
Test for potassium Test for double bonds Purity Loss on drying Acidity or alkalinity Aldehydes Arsenic Lead Mercury
Not more than 1,0 % (105 C, 3 hours) Not more than about 1,0 % (as sorbic acid or K2CO3) Not more than 0,1 %, calculated as formaldehyde Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 203 CALCIUM SORBATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 231-321-6 Calcium sorbate; Calcium salts of trans, trans-2,4-hexadienoic acid C12H14O4Ca 262,32 Content not less than 98 % on the dried basis
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Description
Fine white crystalline powder not showing any change in colour after heating at 105 C for 90 minutes
Identification Melting range for sorbic acid Melting range of sorbic acid isolated by acidification and not recrystallised 133 C to 135 C after vacuum drying in a sulphuric acid desiccator Passes test Passes test
Test for calcium Test for double bonds Purity Loss on drying
Not more than 2,0 %, determined by vacuum drying for four hours in a sulphuric acid desiccator Not more than 0,1 % (as formaldehyde) Not more than 10 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
Aldehydes Fluoride Arsenic Lead Mercury
E 210 BENZOIC ACID Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Melting range Sublimation test Test for benzoate pH 121,5 C -123,5 C Passes test Passes test About 4 (solution in water) 200-618-2 Benzoic acid; Benzenecarboxylic acid; Phenylcarboxylic acid C7H6O2 122,12 Content not less than 99,5 % on the anhydrous basis White crystalline powder
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Purity Loss on drying Sulphated ash Chlorinated organic compounds Not more than 0,5 % (3 hours, over sulphuric acid) Not more than 0,05 % Not more than 0,07 % expressed as chloride corresponding to 0,3 % expressed as monochlorobenzoic acid Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required A cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC (1), 0,3 ml of ferric chloride TSC (2), 0,1 ml of copper sulphate TSC (3) and 4,4 ml of water On fractional acidification of a neutralised solution of benzoic acid, the first precipitate must not have a different melting point from that of the benzoic acid Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
Readily oxidisable substances
Readily carbonisable substances
Polycyclic acids
Arsenic Lead Mercury
E 211 SODIUM BENZOATE Synonyms Definition Einecs Chemical name 208-534-8 Sodium benzoate; Sodium salt of benzenecarboxylic acid; Sodium salt of phenylcarboxylic acid
_____________
(1) Cobalt chloride TSC: dissolve approximately 65 g of cobalt chloride CoCl26H2O in a sufficient quantity of a mixture of 25 ml hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place exactly 5 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 5 ml of 3 % hydrogen peroxide, then 15 ml of a 20 % solution of sodium hydroxide. Boil for 10 minutes, allow to cool, add 2 g of potassium iodide and 20 ml of 25 % sulphuric acid. After the precipitate is completely dissolved, titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS. 1 ml of sodium thiosulphate (0,1 N) corresponds to 23,80 mg of CoCl26H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 59,5 mg of CoCl26H2O per ml. (2) Ferric chloride TSC: dissolve approximately 55 g of ferric chloride in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 15 ml of water and 3 g of potassium iodide; leave the mixture to stand for 15 minutes. Dilute with 100 ml of water then titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS. 1 ml of sodium thiosulphate (0,1 N) corresponds to 27,03 mg of FeCl36H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water to give a solution containing 45,0 mg of FeCl36H2O per ml. (3) Copper sulphate TSC: dissolve approximate by 65 g of copper sulphate CuSO45H2O in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 40 ml of water, 4 ml of acetic acid and 3 g of potassium iodide. Titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS (*). 1 ml of sodium thiosulphate (0,1 N) corresponds to 24,97 mg of CuSO45H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 62,4 mg of CuSO45H2O per ml. (*) Starch TS: triturate 0,5 g starch (potato starch, maize starch or soluable starch) with 5 ml of water; to the resulting paste add a sufficient quantity of water to give a total volume of 100 ml, stirring all the time. Boil for a few minutes, allow to cool, filter. The starch must be freshly prepared.
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Chemical formula Molecular weight Assay Description Identification Solubility Melting range for benzoic acid
C7H5O2Na 144,11 Not less than 99 % of C7H5O2Na, after drying at 105 C for four hours A white, almost odourless, crystalline powder or granules
Freely soluble in water, sparingly soluble in ethanol Melting range of benzoic acid isolated by acidification and not recryst allised 121,5 C to 123,5 C, after drying in a sulphuric acid desiccator Passes test Passes test
Test for benzoate Test for sodium Purity Loss on drying Readily oxidisable substances
Not more than 1,5 % (105 C, 4 hours) Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required On fractional acidification of a (neutralised) solution of sodium benzoate, the first precipitate must not have a different melting range from that of benzoic acid Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid Neutralisation of 1 g of sodium benzoate, in the presence of phenolph thalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
Polycyclic acids
Chlorinated organic compounds
Acidity or alkalinity
E 212 POTASSIUM BENZOATE Synonyms Definition Einecs Chemical name 209-481-3 Potassium benzoate; Potassium salt of benzenecarboxylic acid; Potassium salt of phenylcarboxylic acid
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Chemical formula
C7H5KO23H2O
Molecular weight
214,27
Assay
Content not less than 99 % C7H5KO2 after drying at 105 C to constant weight
Description
White crystalline powder
Identification
Melting range for benzoic acid
Melting range of benzoic acid isolated by acidification and not recryst allised 121,5 C to 123,5 C, after vacuum drying in a sulphuric acid desiccator
Test for benzoate
Passes test
Test for potassium
Passes test
Purity
Loss on drying
Not more than 26,5 % (105 C, 4 hours)
Chlorinated organic compounds
Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid
Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
A cold solution of 0,5 g of benzoic acid in 5 ml 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water
Polycyclic acids
On fractional acidification of a (neutralised) solution of potassium benzoate, the first precipitate must not have a different melting range from that of benzoic acid
Neutralisation of 1 g of potassium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
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E 213 CALCIUM BENZOATE Synonyms Definition Einecs Chemical name Chemical formula 218-235-4 Calcium benzoate; Calcium dibenzoate Anhydrous: Monohydrate: Trihydrate: Molecular weight Anhydrous: Monohydrate: Trihydrate: Assay Description Identification Melting range for benzoic acid Melting range of benzoic acid isolated by acidification and not recryst allised 121,5 C to 123,5 C, after vacuum drying in a sulphuric acid desiccator Passes test Passes test C14H10O4Ca C14H10O4CaH2O C14H10O4Ca3H2O 282,31 300,32 336,36 Monocalcium benzoate
Content not less than 99 % after drying at 105 C White or colourless crystals, or white powder
Test for benzoate Test for calcium Purity Loss on drying Water insoluble matter Chlorinated organic compounds
Not more than 17,5 % (105 C, to constant weight) Not more than 0,3 % Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
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Cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water On fractional acidification of a (neutralised) solution of calcium benzoate, the first precipitate must not be a different melting range from that of benzoic acid Neutralisation of 1 g of calcium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl Not more than 10 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
Polycyclic acids
Fluoride Arsenic Lead Mercury
E 214 ETHYL p-HYDROXYBENZOATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description 204-399-4 Ethyl-p-hydroxybenzoate; Ethyl ester of p-hydroxybenzoic acid C9H10O3 166,8 Content not less than 99,5 % after drying for two hours at 80 C Almost odourless, small, colourless crystals or a white, crystalline powder Ethylparaben; Ethyl p-oxybenzoate
Identification Melting range Test for p-hydroxybenzoate 115-118 C Melting range of p-hydroxybenzoic acid isolated by acidification and not recrystallised: 213 C to 217 C, after vacuum drying in a sulphuric acid desiccator Passes test
Test for alcohol Purity Loss on drying Sulphated ash
Not more than 0,5 % (80 C, 2 hours) Not more than 0,05 %
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p-Hydroxybenzoic acid and salicylic acid Arsenic Lead Mercury
Not more than 0,35 % expressed as p-hydroxybenzoic acid
E 215 SODIUM ETHYL p-HYDROXYBENZOATE Synonyms Definition Einecs Chemical name 252-487-6 Sodium ethyl p-hydroxybenzoate; Sodium compound of the ethyl ester of p-hydroxybenzoic acid C9H9O3Na 188,8 Content of ethylester of p-hydroxybenzoic acid not less than 83 % on the anhydrous basis White, crystalline hygroscopic powder
Description Identification Melting range Test for p-hydroxybenzoate
115 C to 118 C, after vacuum drying in a sulphuric acid desiccator Melting range of p-hydroxybenzoic acid derived from the sample is 213 C to 217 C Passes test 9,9-10,3 (0,1 % aqueous solution)
Test for sodium pH Purity Loss on drying Sulphated ash p-Hydroxybenzoic acid and salicylic acid Arsenic Lead Mercury
Not more than 5 %, (by vacuum drying in a sulphuric acid desiccator) 37 to 39 % Not more than 0,35 % expressed as p-hydroxybenzoic acid
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E 218 METHYL p-HYDROXYBENZOATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Melting range Test for p-hydroxybenzoate 125 C - 128 C Melting range of p-hydroxybenzoic acid derived from the sample is 213 C to 217 C after drying for two hours at 80 C 243-171-5 Methyl p-hydroxybenzoate; Methyl ester of p-hydroxybenzoic acid C8H8O3 152,15 Content not less than 99 % after drying for two hours at 80 C Almost odourless, small colourless crystals or white crystalline powder Methylparaben; Methyl-p-oxybenzoate
Purity Loss on drying Sulphated ash p-Hydroxybenzoic acid and salicylic acid Arsenic Lead Mercury Not more than 0,5 % (80 C, 2 hours) Not more than 0,05 % Not more than 0,35 % expressed as p-hydroxybenzoic acid
E 219 SODIUM METHYL p-HYDROXYBENZOATE Synonyms Definition Einecs Chemical name Sodium methyl p-hydroxybenzoate; Sodium compound of the methylester of p-hydroxybenzoic acid C8H7O3Na 174,15 Content not less than 99,5 % on the anhydrous basis
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Description Identification Melting range
White, hygroscopic powder
The white precipitate formed by acidifying with hydrochloric acid a 10 % (w/v) aqueous solution of the sodium derivative of methyl phydroxybenzoate (using litmus paper as indicator) shall, when washed with water and dried at 80 C for two hours, have a melting range of 125 C to 128 C Passes test 9,7-10,3 (0,1 % solution in carbon dioxide free water)
Test for sodium pH Purity Water content Sulphated ash p-Hydroxybenzoic acid and salicylic acid Arsenic Lead Mercury
Not more than 5 % (Karl Fischer method) 40 % to 44,5 % on the anhydrous basis Not more than 0,35 % expressed as p-hydroxybenzoic acid
E 220 SULPHUR DIOXIDE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for sulphurous substances Purity Water content Non-volatile residue Not more than 0,05 % (Karl Fischer method) Not more than 0,01 % Passes test 231-195-2 Sulphur dioxide; Sulphurous acid anhydride SO2 64,07 Content not less than 99 % Colourless, non-flammable gas with strong pungent suffocating odour
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Sulphur trioxide Selenium Other gases not normally present in the air Arsenic Lead Mercury
Not more than 0,1 % Not more than 10 mg/kg No trace
E 221 SODIUM SULPHITE Synonyms Definition Einecs Chemical name Chemical formula 231-821-4 Sodium sulphite (anhydrous or heptahydrate) Anhydrous: Heptahydrate: Molecular weight Anhydrous: Heptahydrate: Assay Anhydrous: Na2SO3 Na2SO37H2O 126,04 252,16 Not less than 95 % of Na2SO3 and not less than 48 % of SO2 Not less than 48 % of Na2SO3 and not less than 24 % of SO2
Heptahydrate:
Description Identification Test for sulphite Test for sodium pH Purity Thiosulphate Iron Selenium
White crystalline powder or colourless crystals
Passes test Passes test 8,5-11,5 (anhydrous: 10 % solution; heptahydrate: 20 % solution)
Not more than 0,1 % based on the SO2 content Not more than 10 mg/kg based on the SO2 content Not more than 5 mg/kg based on the SO2 content
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E 222 SODIUM BISULPHITE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for sulphite Test for sodium pH Purity Iron Selenium Arsenic Lead Mercury Not more than 10 mg/kg of Na2SO3 based on the SO2 content Not more than 5 mg/kg based on the SO2 content Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Passes test Passes test 2,5-5,5 (10 % aqueous solution) 231-921-4 Sodium bisulphite; Sodium hydrogen sulphite NaHSO3 in aqueous solution 104,06 Content not less than 32 % w/w NaHSO3 A clear, colourless to yellow solution
E 223 SODIUM METABISULPHITE Synonyms Definition Einecs Chemical name 231-673-0 Sodium disulphite; Disodium pentaoxodisulphate Pyrosulphite; Sodium pyrosulphite
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Chemical formula Molecular weight Assay Description Identification Test for sulphite Test for sodium pH Purity Thiosulphate Iron Selenium Arsenic Lead Mercury
Na2S2O5 190,11 Content not less than 95 % Na2S2O5 and not less than 64 % of SO2 White crystals or crystalline powder
Passes test Passes test 4,0-5,5 (10 % aqueous solution)
Not more than 0,1 % based on the SO2 content Not more than 10 mg/kg based on the SO2 content Not more than 5 mg/kg based on the SO2 content Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 224 POTASSIUM METABISULPHITE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 240-795-3 Potassium disulphite; Potassium pentaoxo disulphate K2S2O5 222,33 Content not less than 90 % K2S2O5 and not less than 51,8 % of SO2, the remainder being composed almost entirely of potassium sulphate Colourless crystals or white crystalline powder Potassium pyrosulphite
Description Identification Test for sulphite Test for potassium
Passes test Passes test
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Purity Thiosulphate Iron Selenium Arsenic Lead Mercury Not more than 0,1 % based on the SO2 content Not more than 10 mg/kg based on the SO2 content Not more than 5 mg/kg based on the SO2 content Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 226 CALCIUM SULPHITE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 218-235-4 Calcium sulphite CaSO32H2O 156,17 Content not less than 95 % of CaSO32H2O and not less than 39 % of SO2 White crystals or white crystalline powder
Description Identification Test for sulphite Test for calcium Purity Iron Selenium Arsenic Lead Mercury
Not more than 10 mg/kg based on the SO2 content Not more than 5 mg/kg based on the SO2 content Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 227 CALCIUM BISULPHITE Synonyms Definition Einecs 237-423-7
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Chemical name Chemical formula Molecular weight Assay
Calcium bisulphite; Calcium hydrogen sulphite Ca(HSO3)2 202,22 6 to 8 % (w/v) of sulphur dioxide and 2,5 to 3,5 % (w/v) of calcium dioxide corresponding to 10 to 14 % (w/v) of calcium bisulphite [Ca(HSO3)2] Clear greenish-yellow aqueous solution having a distinct odour of sulphur dioxide
Description
Identification Test for sulphite Test for calcium Purity Iron Selenium Arsenic Lead Mercury Not more than 10 mg/kg based on the SO2 content Not more than 5 mg/kg based on the SO2 content Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Passes test Passes test
E 228 POTASSIUM BISULPHITE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for sulphite Test for potassium Purity Iron Selenium Not more than 10 mg/kg based on the SO2 content Not more than 5 mg/kg based on the SO2 content Passes test Passes test 231-870-1 Potassium bisulphite; Potassium hydrogen sulphite KHSO3 in aqueous solution 120,17 Content not less than 280 g KHSO3 per litre (or 150 g SO2 per litre) Clear colourless aqueous solution
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E 234 NISIN Synonyms Definition Nisin consists of several closely related polypeptides produced by strains of Lactococcus lactis subsp. lactis 215-807-5
Einecs Chemical name Chemical formula Molecular weight Assay
C143H230N42O37S7 3 354,12 Nisin concentrate contains not less than 900 units per mg in a mixture of non-fat milk solids and a minimum sodium chloride content of 50 % White powder
Description Identification Purity Loss on drying Arsenic Lead Mercury
Not more than 3 % (102 C to 103 C, to constant weight) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 235 NATAMYCIN Synonyms Definition Pimaricin Natamycin is a fungicide of the polyene macrolide group, and is produced by strains of Streptomyces natalensis and other relevant species 231-683-5 A stereoisomer of 22-(3-Amino-3,6-dideoxy--Dmannopyranosyloxy)-1,3,26-trihydroxy-12-methyl-10-oxo-6,11,28trioxatricyclo[22.3.1.05,7]octacosa-8,14,16,18,20-pentaene-25carboxylic acid. C33H47O13N 665,74 Content not less than 95 % on the dried basis
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Description Identification Colour reactions
White to creamy-white crystalline powder
On adding a few crystals of natamycin on a spot plate, to a drop of: concentrated hydrochloric acid, a blue colour develops, concentrated phosphoric acid, a green colour develops,which changes into pale red after a few minutes
Spectrometry
A 0,0005 % w/v solution in 1 % methanolic acetic acid solution has absorption maxima at about 290 nm, 303 nm and 318 nm, a shoulder at about 280 nm and exhibits minima at about 250 nm, 295,5 nm and 311 nm 5,5-7,5 (1 % w/v solution in previously neutralised mixture of 20 parts dimethylformamide and 80 parts of water) []D20 + 250 to + 295 (a 1 % w/v solution in glacial acetic acid, at 20 C and calculated with reference to the dried material)
pH
Specific rotation
Purity Loss on drying Sulphated ash Arsenic Lead Mercury Microbiological criteria Total plate count Not more than 100 colonies per gram Not more than 8 % (over P2O5, in vacuum at 60 C to constant weight) Not more than 0,5 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 239 HEXAMETHYLENE TETRAMINE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for formaldehyde Passes test 202-905-8 1,3,5,7-Tetraazatricyclo [3.3.1.13,7]-decane, hexamethylenetetramine C6H12N4 140,19 Content not less than 99 % on the anhydrous basis Colourless or white crystalline powder Hexamine; Methenamine
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Test for ammonia Sublimation point: Purity Loss on drying Sulphated ash Sulphates Chlorides Ammonium salts Arsenic Lead Mercury
Passes test Approximately 260 C
Not more than 0,5 % (at 105 C in vacuum over P2O5 for 2 hours) Not more than 0,05 % Not more than 0,005 % expressed as SO4 Not more than 0,005 % expressed as Cl Not detectable Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 242 DIMETHYL DICARBONATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description 224-859-8 Dimethyl dicarbonate; Pyrocarbonic acid dimethyl ester C4H6O5 134,09 Content not less than 99,8 % Colourless liquid, decomposes in aqueous solution. It is corrosive to skin and eyes and toxic by inhalation and ingestion DMDC; Dimethyl pyrocarbonate
Identification Decomposition Melting point Boiling point Density 20 C Infrared absorption spectrum After dilution positive tests for CO2 and methanol 17 C 172 C with decomposition Approximately 1,25 g/cm3 Maxima at 1 156 and 1 832 cm-1
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Purity Dimethyl carbonate Chlorine, total Arsenic Lead Mercury Not more than 0,2 % Not more than 3 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 249 POTASSIUM NITRITE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for nitrite Test for potassium pH Purity Loss on drying Arsenic Lead Mercury Not more than 3 % (4 hours, over silica gel) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Passes test Passes test 6,0-9,0 (5 % solution) 231-832-4 Potassium nitrite KNO2 85,11 Content not less than 95 % on the anhydrous basis (1) White or slightly yellow, deliquescent granules
E 250 SODIUM NITRITE Synonyms Definition Einecs Chemical name Chemical formula _____________
(1) May only be sold in a mixture with salt or a salt substitute.
231-555-9 Sodium nitrite NaNO2
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Molecular weight Assay Description Identification Test for nitrite Test for sodium Purity Loss on drying Arsenic Lead Mercury
69,00 Content not less than 97 % on the anhydrous basis (1) White crystalline powder or yellowish lumps
Not more than 0,25 % (4 hours, over silica gel) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 251 SODIUM NITRATE (i) SOLID SODIUM NITRATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for nitrate Test for sodium pH Purity Loss on drying Nitrites Arsenic Lead Mercury Not more than 2 % (105 C, 4 hours) Not more than 30 mg/kg expressed as NaNO2 Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Passes test Passes test 5,5-8,3 (5 % solution) 231-554-3 Sodium nitrate NaNO3 85,00 Content not less than 99 % on the anhydrous basis White crystalline, slightly hygroscopic powder Chile saltpetre; Cubic or soda nitre
(1) May only be sold in a mixture with salt or a salt substitute.
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(ii) LIQUID SODIUM NITRATE Synonyms Definition Liquid sodium nitrate is an aqueous solution of sodium nitrate as the direct result of the chemical reaction between sodium hydroxide and nitric acid in stoechiometric amounts, without subsequent crystalli sation. Standardised forms prepared from liquid sodium nitrate meeting these specifications may contain nitric acid in excessive amounts, if clearly stated or labelled. 231-554-3 Sodium nitrate NaNO3 85,00 Content between 33,5 % and 40,0 % of NaNO3 Clear colourless liquid
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for nitrate Test for sodium pH Purity Free nitric acid Nitrites Arsenic Lead Mercury
Passes test Passes test 1,5-3,5
Not more than 0,01 % Not more than 10 mg/kg expressed as NaNO2 Not more than 1 mg/kg Not more than 1 mg/kg Not more than 0,3 mg/kg
This specification refers to a 35 % aqueous solution.
E 252 POTASSIUM NITRATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for nitrate Test for potassium pH Passes test Passes test 4,5-8,5 (5 % solution) 231-818-8 Potassium nitrate KNO3 101,11 Content not less than 99 % on the anhydrous basis White crystalline powder or transparent prisms having a cooling, saline, pungent taste Chile saltpetre; Cubic or soda nitre
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Purity Loss on drying Nitrites Arsenic Lead Mercury Not more than 1 % (105 C, 4 hours) Not more than 20 mg/kg expressed as KNO2 Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 260 ACETIC ACID Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Boiling point Specific gravity Test for acetate Solidification point Purity Non-volatile residue Formic acid, formates oxidisable substances and other Not more than 100 mg/kg Not more than 1 000 mg/kg expressed as formic acid Dilute 2 ml of the sample in a glass-stoppered container with 10 ml of water and add 0,1 ml of 0,1 N potassium permanganate. The pink colour does not change to brown within 30 minutes Not more than 1 mg/kg Not more than 0,5 mg/kg Not more than 1 mg/kg 118 C at 760 mm pressure (of mercury) About 1,049 A one in three solution gives positive tests for acetate Not lower than 14,5 C 200-580-7 Acetic acid; Ethanoic acid C2H4O2 60,05 Content not less than 99,8 % Clear, colourless liquid having a pungent, characteristic odour
E 261 POTASSIUM ACETATE Synonyms Definition Einecs Chemical name 204-822-2 Potassium acetate
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C2H3O2K 98,14 Content not less than 99 % on the anhydrous basis Colourless, deliquescent crystals or a white crystalline powder, odourless or with a faint acetic odour
Identification pH Test for acetate Test for potassium Purity Loss on drying Formic acid, formates oxidisable substances Arsenic Lead Mercury and other Not more than 8 % (150 C, 2 hours) Not more than 1 000 mg/kg expressed as formic acid 7,5-9,0 (5 % aqueous solution) Passes test Passes test
E 262 (i) SODIUM ACETATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight 204-823-8 Sodium acetate C2H3NaO2nH2O (n = 0 or 3) Anhydrous: Trihydrate: Assay 82,03 136,08
Content (for both of anhydrous and trihydrate form) not less than 98,5 % on the anhydrous basis Anhydrous: White, odourless, granular, hygroscopic powder Colourless, transparent crystals or a granular crystalline powder, odourless or with a faint, acetic odour. Effloresces in warm, dry air
Description
Trihydrate:
Identification pH Test for acetate 8,0-9,5 (1 % aqueous solution) Passes test
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Test for sodium Purity Loss on drying
Passes test
Anhydrous: Trihydrate:
Not more than 2 % (120 C, 4 hours) Between 36 and 42 % (120 C, 4 hours)
Formic acid, formates oxidisable substances Arsenic Lead Mercury
and
other
Not more than 1 000 mg/kg expressed as formic acid Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 262 (ii) SODIUM DIACETATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification pH Test for acetate Test for sodium Purity Water content Formic acid, formates oxidisable substances Arsenic Lead Mercury and other Not more than 2 % (Karl Fischer method) Not more than 1 000 mg/kg expressed as formic acid Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg 4,5-5,0 (10 % aqueous solution) Passes test Passes test Sodium diacetate is a molecular compound of sodium acetate and acetic acid 204-814-9 Sodium hydrogen diacetate C4H7NaO4nH2O (n = 0 or 3) 142,09 (anhydrous) Content 39 to 41 % of free acetic acid and 58 to 60 % of sodium acetate White, hygroscopic crystalline solid with an acetic odour
E 263 CALCIUM ACETATE Synonyms Definition Einecs Chemical name 200-540-9 Calcium acetate
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Chemical formula
Anhydrous: Monohydrate:
C4H6O4Ca C4H6O4CaH2O 158,17 176,18
Molecular weight
Anhydrous: Monohydrate:
Assay Description
Content not less than 98 % on the anhydrous basis Anhydrous calcium acetate is a white, hygroscopic, bulky, crystalline solid with a slightly bitter taste. A slight odour of acetic acid may be present. The monohydrate may be needles, granules or powder
Identification pH Test for acetate Test for calcium Purity Loss on drying Water insoluble matter Formic acid, formates oxidisable substances Arsenic Lead Mercury and other Not more than 11 % (155 C to constant weight, for the monohy drate) Not more than 0,3 % Not more than 1 000 mg/kg expressed as formic acid Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg 6,0-9,0 (10 % aqueous solution) Passes test Passes test
E 270 LACTIC ACID Synonyms Definition Consists of a mixture of lactic acid (C3H6O3) and lactic acid lactate (C6H10O5). It is obtained by the lactic fermentation of sugars or is prepared synthetically. Lactic acid is hygroscopic and when concentrated by boiling, it condenses to form lactic acid lactate, which on dilution and heating hydrolyses to lactic acid. Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for lactate Purity Sulphated ash Chloride Not more than 0,1 % Not more than 0,2 % Passes test 200-018-0 Lactic acid; 2-Hydroxypropionic acid; 1-Hydroxyethane-1-carboxylic acid C3H6O3 90,08 Content not less than 76 % Colourless or yellowish, nearly odourless, syrupy liquid to solid
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Sulphate Iron Arsenic Lead Mercury
Note: This specification refers to a 80 % aqueous solution; for weaker aqueous solutions, calculate values corresponding to their lactic acid content
E 280 PROPIONIC ACID Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Melting point Distillation range Purity Non-volatile residue Aldehydes Arsenic Lead Mercury Not more than 0,01 % when dried at 140 C to constant weight Not more than 0,1 % expressed as formaldehyde Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg 22 C 138,5 C to 142,5 C 201-176-3 Propionic acid; Propanoic acid C3H6O2 74,08 Content not less than 99,5 % Colourless or slightly yellowish, oily liquid with a slightly pungent odour
E 281 SODIUM PROPIONATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 205-290-4 Sodium propionate; Sodium propanoate C3H5O2Na 96,06 Content not less than 99 % after drying for two hours at 105 C
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Description Identification Test for propionate Test for sodium pH Purity Loss on drying Water insoluble matter Iron Arsenic Lead Mercury
White crystalline hygroscopic powder, or a fine white powder
Passes test Passes test 7,5-10,5 (10 % aqueous solution)
Not more than 4 % (105 C, 2 hours) Not more than 0,1 % Not more than 50 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg
E 282 CALCIUM PROPIONATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for propionate Test for calcium pH Purity Loss on drying Water insoluble matter Iron Fluoride Arsenic Lead Mercury Not more than 4 % (105 C, 2 hours) Not more than 0,3 % Not more than 50 mg/kg Not more than 10 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Passes test Passes test 6,0-9,0 (10 % aqueous solution) 223-795-8 Calcium propionate C6H10O4Ca 186,22 Content not less than 99 %, after drying for two hours at 105 C White crystalline powder
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E 283 POTASSIUM PROPIONATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for propionate Test for potassium Purity Loss on drying Water insoluble matter Iron Fluoride Arsenic Lead Mercury Not more than 4 % (105 C, 2 hours) Not more than 0,1 % Not more than 30 mg/kg Not more than 10 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Passes test Passes test 206-323-5 Potassium propionate; Potassium propanoate C3H5KO2 112,17 Content not less than 99 % after drying for two hours at 105 C White crystalline powder
E 284 BORIC ACID Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Melting point Burning test pH Purity Peroxides Arsenic No colour develops with added KI-solution Not more than 1 mg/kg At approximately 171 C Burns with a nice green flame 3,8-4,8 (3,3 % aqueous solution) H3BO3 61,84 Content not less than 99,5 % Colourless, odourless, transparent crystals or white granules or powder; slightly unctuous to the touch; occurs in nature as the mineral sassolite 233-139-2 Boracic acid; Orthoboric acid; Borofax
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Lead Mercury
E 285 SODIUM TETRABORATE (BORAX) Synonyms Definition Einecs Chemical name Chemical formula 215-540-4 Sodium tetraborate; Sodium biborate; Sodium pyroborate; Anhydrous tetraborate Na2B4O7 Na2B4O710H2O Molecular weight Assay Description Identification Melting range Purity Peroxides Arsenic Lead Mercury No colour develops with added KI-solution Not more than 1 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Between 171 C and 175 C with decomposition Powder or glass-like plates becoming opaque on exposure to air; slowly soluble in water 201,27 Sodium borate
E 290 CARBON DIOXIDE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description 204-696-9 Carbon dioxide CO2 44,01 Content not less than 99 % v/v on the gaseous basis A colourless gas under normal environmental conditions with a slight pungent odour. Commercial carbon dioxide is shipped and handled as a liquid in pressurised cylinders or bulk storage systems, or in compressed solid blocks of dry ice. Solid (dry ice) forms usually contain added substances, such as propylene glycol or mineral oil, as binders Carbonic acid gas; Dry ice (solid form); Carbonic anhydride
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Identification Precipitate formation When a stream of the sample is passed through a solution of barium hydroxide, a white precipitate is produced which dissolves with effer vescence in dilute acetic acid
Purity Acidity 915 ml of gas bubbled through 50 ml of freshly boiled water must not render the latter more acid to methylorange than is 50 ml freshly boiled water to which has been added 1 ml of hydrochloric acid (0,01 N) hydrogen 915 ml of gas bubbled through 25 ml of ammoniacal silver nitrate reagent to which has been added 3 ml of ammonia must not cause clouding or blackening of this solution Not more than 10 l/l Not more than 5 mg/kg
Reducing substances, phosphide and sulphide Carbon monoxide Oil content
E 296 MALIC ACID Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Melting range Test for malate Purity Sulphated ash Fumaric acid Maleic acid Arsenic Lead Mercury Not more than 0,1 % Not more than 1,0 % Not more than 0,05 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg 127-132 C Passes test 230-022-8, 210-514-9, 202-601-5 hydroxybutanedioic acid; hydroxysuccinic acid C4H6O5 134,09 Content not less than 99,0 % White or nearly white crystalline powder or granules Pomalous acid
E 297 FUMARIC ACID Synonyms Definition Einecs Chemical name 203-743-0 trans-Butenedioic acid; trans-1,2-Ethylene-dicarboxylic acid
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Chemical formula Molecular weight Assay Description Identification Melting range Test for double bonds Test for 1,2-dicarboxylic acid pH Purity Loss on drying Sulphated ash Maleic acid Arsenic Lead Mercury
C4H4O4 116,07 Content not less than 99,0 % on the anhydrous basis White crystalline powder or granules
286-302 C (closed capillary, rapid heating) Passes test Passes test 3,0-3,2 (0,05 % solution at 25 C)
Not more than 0,5 % (120 C, 4 hours) Not more than 0,1 % Not more than 0,1 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 300 ASCORBIC ACID, L-ASCORBIC ACID Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Melting range Identification Test for ascorbic acid pH Specific rotation Purity Loss on drying Sulphated ash Not more than 0,4 % (in vacuum over sulphuric acid, 24 hours) Not more than 0,1 % Passes test Between 2,4 and 2,8 (2 % aqueous solution) []D20 between + 20,5 and + 21,5 (10 % w/v aqueous solution) 200-066-2 L-ascorbic acid; Ascorbic acid; 2,3-Didehydro-L-threo-hexono-1,4lactone; 3-Keto-L-gulofuranolactone C6H8O6 176,13 contains not less than 99 % of C6H8O6 after drying in a vacuum desiccator over sulphuric acid for 24 hours, White to pale yellow, odourless crystalline powder Between 189 C and 193 C with decomposition L-xylo-Ascorbic acid; L(+)- Ascorbic acid
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E 301 SODIUM ASCORBATE Synonyms Definition Einecs Chemical name 205-126-1 Sodium ascorbate; Sodium L-ascorbate; 2,3-Didehydro-L-threo-hexono1,4-lactone sodium enolate; 3-Keto-L-gulofurano-lactone sodium enolate C6H7O6Na 198,11 Sodium ascorbate, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H7O6Na White or almost white, odourless crystalline powder which darkens on exposure to light Sodium L-ascorbate; L-Ascorbic acid monosodium salt
Chemical formula Molecular weight Assay Description Identification Test for ascorbate Test for sodium pH Specific rotation Purity Loss on drying Arsenic Lead Mercury
Passes test Passes test Between 6,5 and 8,0 (10 % aqueous solution) []D20 between + 103 and + 106 (10 % w/v aqueous solution)
Not more than 0,25 % (in vacuum over sulphuric acid, 24 hours) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 302 CALCIUM ASCORBATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 227-261-5 Calcium ascorbate dihydrate; Calcium salt of 2,3-didehydro-L-threohexono-1,4-lactone dihydrate C12H14O12Ca2H2O 426,35 Content not less than 98 % on a volatile matter-free basis Calcium ascorbate dihydrate
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Description Identification Test for ascorbate Test for calcium pH Specific rotation Purity Fluoride Volatile matter
White to slightly pale greyish-yellow odourless crystalline powder
Passes test Passes test Between 6,0 and 7,5 (10 % aqueous solution) []D20 between + 95 and + 97 (5 % w/v aqueous solution)
Not more than 10 mg/kg (expressed as fluorine) Not more than 0,3 % determined by drying at room temperature for 24 hours in a desiccator containing sulphuric acid or phosphorus pentoxide Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 304 (i) ASCORBYL PALMITATE Synonyms Definition Einecs Chemical name 205-305-4 Ascorbyl palmitate; L-ascorbyl hexono-1,4-lactone-6-palmitate; actone C22H38O7 414,55 Content not less than 98 % on the dried basis White or yellowish-white powder with a citrus-like odour palmitate; 2,3-didehydro-L-threo6-palmitoyl-3-keto-L-gulofuranol L-ascorbyl palmitate
Chemical formula Molecular weight Assay Description Identification Melting range Specific rotation Purity Loss on drying Sulphated ash Arsenic Lead Mercury
Between 107 C and 117 C []D20 between + 21 and + 24 (5 % w/v in methanol solution)
Not more than 2,0 % (vacuum oven, 56-60 C, 1 hour) Not more than 0,1 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
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E 304 (ii) ASCORBYL STEARATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Melting point Purity Loss on drying Sulphated ash Arsenic Lead Mercury Not more than 2,0 % (vacuum oven, 56-60 C, 1 hour) Not more than 0,1 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg About 116 C 246-944-9 Ascorbyl stearate; L-ascorbyl stearate; 2,3-didehydro-L-threo-hexono1,4-lactone-6-stearate; 6-stearoyl-3-keto-L-gulofuranolactone C24H42O7 442,6 Content not less than 98 % White or yellowish, white powder with a citrus-like odour
E 306 TOCOPHEROL-RICH EXTRACT Synonyms Definition Product obtained by the vacuum steam distillation of edible vegetable oil products, comprising concentrated tocopherols and tocotrienols Contains tocopherols such as d--, d--, d-- and d--tocopherols Einecs Chemical name Chemical formula Molecular weight Assay Description 430,71 (d--tocopherol) Content not less than 34 % of total tocopherols Brownish red to red, clear, viscous oil having a mild, characteristic odour and taste. May show a slight separation of wax-like constituents in microcrystalline form
Identification By suitable gas liquid chromatographic method Specific rotation Solubility Purity Sulphated ash Not more than 0,1 % []D20 not less than + 20 Insoluble in water. Soluble in ethanol. Miscible in ether
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E 307 ALPHA-TOCOPHEROL Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Spectrophotometry Specific rotation Purity Refractive index Specific absorption in ethanol [n]D20 1,503-1,507 E1% 1cm (292 nm) 71-76 (0,01 g in 200 ml of absolute ethanol) Sulphated ash Lead Not more than 0,1 % Not more than 2 mg/kg Insoluble in water, freely soluble in ethanol, miscible in ether In absolute ethanol the maximum absorption is about 292 nm []D25 0 0,05 (1 in 10 solution in chloroform) 233-466-0 DL-5,7,8-Trimethyltocol; DL-2,5,7,8-tetramethyl-2-(4,8,12-trimethyl tridecyl)-6-chromanol C29H50O2 430,71 Content not less than 96 % Slightly yellow to amber, nearly odourless, clear, viscous oil which oxidises and darkens on exposure to air or light dl--Tocopherol; (all rac)--Tocopherol
E 308 GAMMA-TOCOPHEROL Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Spectrometry Maximum absorptions in absolute ethanol at about 298 nm and 257 nm 231-523-4 2,7,8-trimethyl-2-(4,8,12-trimethyltridecyl)-6-chromanol C28H48O2 416,69 Content not less than 97 % Clear, viscous, pale yellow oil which oxidises and darkens on exposure to air or light dl--Tocopherol
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L 83/97
Purity Specific absorption in ethanol E1% 1cm (298 nm) between 91 and 97 E1% 1cm (257 nm) between 5,0 and 8,0 Refractive index Sulphated ash Arsenic Lead Mercury [n]D20 1,503-1,507 Not more than 0,1 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 309 DELTA-TOCOPHEROL Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Spectrometry Purity Specific absorption E1% 1cm in ethanol E1% 1cm (298 nm) between 89 and 95 E1% 1cm (257 nm) between 3,0 and 6,0 Refractive index Sulphated ash Arsenic Lead Mercury [n]D20 1,500-1,504 Not more than 0,1 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Maximum absorptions in absolute ethanol at about 298 nm and 257 nm 204-299-0 2,8-dimethyl-2-(4,8,12-trimethyltridecyl)-6-chromanol C27H46O2 402,7 Content not less than 97 % Clear, viscous, pale yellowish or orange oil which oxidises and darkens on exposure to air or light
E 310 PROPYL GALLATE Synonyms Definition Einecs Chemical name 204-498-2 Propyl gallate; Propyl ester of gallic acid; n-propyl ester of 3,4,5-trihy droxybenzoic acid
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Chemical formula Molecular weight Assay Description Identification Solubility Melting range Purity Loss on drying Sulphated ash Free acid Chlorinated organic compound Specific absorption in ethanol Arsenic Lead Mercury
C10H12O5 212,20 Content not less than 98 % on the anhydrous basis White to creamy-white, crystalline, odourless solid
Slightly soluble in water, freely soluble in ethanol, ether and propane1,2-diol Between 146 C and 150 C after drying at 110 C for four hours
Not more than 0,5% (110 C, 4 hours) Not more than 0,1 % Not more than 0,5 % (as gallic acid) Not more than 100 mg/kg (as C1) E1% 1cm (275 nm) not less than 485 and not more than 520 Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 311 OCTYL GALLATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Melting range Purity Loss on drying Sulphated ash Free acid Chlorinated organic compound Specific absorption in ethanol Not more than 0,5 % (90 C, 6 hours) Not more than 0,05 % Not more than 0,5 % (as gallic acid) Not more than 100 mg/kg (as C1) E1% 1cm (275 nm) not less than 375 and not more than 390 Insoluble in water, freely soluble in ethanol, ether and propane-1,2-diol Between 99 C and 102 C after drying at 90 C for six hours 213-853-0 Octyl gallate; Octyl ester of gallic acid; n-octyl ester of 3,4,5-trihydroxy benzoic acid C15H22O5 282,34 Content not less than 98 % after drying at 90 C for six hours White to creamy-white odourless solid
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L 83/99
E 312 DODECYL GALLATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Melting range Purity Loss on drying Sulphated ash Free acid Chlorinated organic compound Specific absorption in ethanol Arsenic Lead Mercury Not more than 0,5 % (90 C, 6 hours) Not more than 0,05 % Not more than 0,5 % (as gallic acid) Not more than 100 mg/kg (as Cl) E1% 1cm (275 nm) not less than 300 and not more than 325 Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Insoluble in water, freely soluble in ethanol and ether Between 95 C and 98 C after drying at 90 C for six hours 214-620-6 Dodecyl gallate; n-dodecyl (or lauryl) ester of 3,4,5-trihydroxybenzoic acid; Dodecyl ester of gallic acid C19H30O5 338,45 Content not less than 98 % after drying at 90 C for six hours White or creamy-white odourless solid Lauryl gallate
E 315 ERYTHORBIC ACID Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description 201-928-0 D-Erythro-hex-2-enoic acid -lactone; Isoascorbic acid; D-Isoascorbic acid C6H8O6 176,13 Content not less than 98 % on the anhydrous basis White to slightly yellow crystalline solid which darkens gradually on exposure to light Isoascorbic acid; D-Araboascorbic acid
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Identification Melting range Test for ascorbic acid/colour reaction Specific rotation Purity Loss on drying Sulphated ash Oxalate Not more than 0,4 % after drying under (reduced pressure on silica gel, 3 hours) Not more than 0,3 % To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear Not more than 2 mg/kg About 164 C to 172 C with decomposition Passes test []D25 10 % (w/v) aqueous solution between 16,5 to 18,0
Lead
E 316 SODIUM ERYTHORBATE Synonyms Definition Einecs Chemical name 228-973-9 Sodium isoascorbate; Sodium D-isoascorbic acid; Sodium salt of 2,3didehydro-D-erythro-hexono-1,4-lactone; 3-keto-D-gulofurano-lactone sodium enolate monohydrate C6H7O6NaH2O 216,13 Content not less than 98 % after drying in a vacuum desiccator over sulphuric acid for 24 hours expressed on the monohydrate basis White crystalline solid Sodium isoascorbate
Chemical formula Molecular weight Assay Description Identification Solubility Test for ascorbic acid/colour reaction Test for sodium pH Specific rotation Purity Loss on drying Oxalate
Freely soluble in water, very slightly soluble in ethanol Passes test Passes test 5,5 to 8,0 (10 % aqueous solution) []D25 10 % (w/v) aqueous solution between + 95 and + 98
Not more than 0,25 % after drying (in vacuum over sulphuric acid, 24 hours) To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear. Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
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L 83/101
E 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ) Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Melting point Phenolics Practically insoluble in water; soluble in ethanol Not less than 126,5 C Dissolve about 5 mg of the sample in 10 ml of methanol and add 10,5 ml of dimethylamine solution (1 in 4). A red to pink colour is produced 217-752-2 Tert-butyl-1,4-benzenediol; 2-(1,1-Dimethylethyl)-1,4-benzenediol C10H14O2 166,22 Content not less than 99 % of C10H14O2 White crystalline solid having a characteristic odour TBHQ
Purity Tertiary-Butyl-p-benzoquinone 2,5-Di-tertiary-butyl hydroquinone Hydroxyquinone Toluene Lead Not more than 0,2 % Not more than 0,2 % Not more than 0,1 % Not more than 25 mg/kg Not more than 2 mg/kg
E 320 BUTYLATED HYDROXYANISOLE (BHA) Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Melting range Colour reaction Insoluble in water, freely soluble in ethanol Between 48 C and 63 C Passes test for phenol groups 246-563-8 3-Tertiary-butyl-4-hydroxyanisole; A mixture of 2-tertiary-butyl-4hydroxyanisole and 3-tertiary-butyl-4-hydroxyanisole C11H16O2 180,25 Content not less than 98,5 % of C11H16O2 and not less than 85 % of 3-tertiary-butyl-4-hydroxyanisole isomer White or slightly yellow flakes or waxy solid with a slight aromatic smell BHA
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Purity Sulphated ash Phenolic impurities Specific absorption Not more than 0,05 % after calcination at 800 25 C Not more than 0,5 % E1% 1cm (290 nm) not less than 190 and not more than 210 E1% 1cm (228 nm) not less than 326 and not more than 345 Arsenic Lead Mercury Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 321 BUTYLATED HYDROXYTOLUENE (BHT) Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description 204-881-4 2,6-Ditertiary-butyl-p-cresol; 4-Methyl-2,6-ditertiarybutylphenol C15H24O 220,36 Content not less than 99 % White, crystalline or flaked solid, odourless or having a characteristic faint aromatic odour BHT
Identification Solubility Insoluble in water and propane- 1,2-diol Freely soluble in ethanol Melting point Spectrometry At 70 C The absorption in the range 230 to 320 nm of a 2 cm layer of a 1 in 100 000 solution in dehydrated ethanol exhibits a maximum only at 278 nm
Purity Sulphated ash Phenolic impurities Specific absorption in ethanol Arsenic Lead Mercury Not more than 0,005 % Not more than 0,5 % E1% 1cm (278 nm) not less than 81 and not more than 88 Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
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L 83/103
E 322 LECITHINS Synonyms Definition Phosphatides; Phospholipids Lecithins are mixtures or fractions of phosphatides obtained by physical procedures from animal or vegetable foodstuffs; they also include hydrolysed products obtained through the use of harmless and appro priate enzymes. The final product must not show any signs of residual enzyme activity The lecithins may be slightly bleached in aqueous medium by means of hydrogen peroxide. This oxidation must not chemically modify the lecithin phosphatides Einecs Chemical name Chemical formula Molecular weight Assay Lecithins: not less than 60,0 % of substances insoluble in acetone Hydrolysed lecithins: not less than 56,0 % of substances insoluble in acetone Description Lecithins: brown liquid or viscous semi-liquid or powder Hydrolysed lecithins: light brown to brown viscous liquid or paste Identification Test for choline Test for phosphorus Test for fatty acids Test for hydrolysed lecithin Passes test Passes test Passes test To a 800 ml beaker add 500 ml of water (30-35 C). Then slowly add 50 ml of the sample with constant stirring. Hydrolysed lecithin will form a homogeneous emulsion. Non-hydrolysed lecithin will form a distinct mass of about 50 g 232-307-2
Purity Loss on drying Toluene-insoluble matter Acid value Not more than 2,0 % (105 C, 1 hour) Not more than 0,3 % Lecithins: not more than 35 mg of potassium hydroxide per gram Hydrolysed lecithins: not more than 45 mg of potassium hydroxide per gram Peroxide value Arsenic Lead Mercury Equal to or less than 10 Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 325 SODIUM LACTATE Synonyms Definition Einecs Chemical name 200-772-0 Sodium lactate; Sodium 2-hydroxypropanoate
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Chemical formula Molecular weight Assay Description Identification Test for lactate Test for potassium pH Purity Acidity Arsenic Lead Mercury Reducing substances
C3H5NaO3 112,06 (anhydrous) Content not less than 57 % and not more than 66 % Colourless, transparent, liquid. Odourless, or with a slight, characteristic odour
Passes test Passes test 6,5 to 7,5 (20 % aqueous solution)
Not more than 0,5 % after drying expressed as lactic acid Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg No reduction of Fehling's solution
Note: This specification refers to a 60 % aqueous solution
E 326 POTASSIUM LACTATE Synonyms Definition Einecs Cheminal name Chemical formula Molecular weight Assay Description Identification Ignition Colour reaction Ignite potassium lactate solution to an ash. The ash is alkaline, and an effervescence occurs when acid is added Overlay 2 ml of potassium lactate solution on 5 ml of a 1 in 100 solution of catechol in sulphuric acid. A deep red colour is produced at the zone of contact Passes test Passes test 213-631-3 Potassium lactate; Potassium 2-hydroxypropanoate C3H5O3K 128,17 (anhydrous) Content not less than 57 % and not more than 66 % Slightly viscous, almost odourless clear liquid. Odourless, or with a slight, characteristic odour
Test for potassium Test for lactate Purity Arsenic Lead
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L 83/105
Mercury Acidity
Not more than 1 mg/kg Dissolve 1 g of potassium lactate solution in 20 ml of water, add 3 drops of phenolphthalein TS and titrate with 0,1 N sodium hydroxide. Not more than 0,2 ml should be required No reduction of Fehling's solution
Reducing substances
E 327 CALCIUM LACTATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for lactate Test for calcium Solubility pH Purity Loss on drying anhydrous: not more than 3,0 % (120 C, 4 hours) with 1 molecule of water: not more than 8,0 % (120 C, 4 hours) with 3 molecules of water: not more than 20,0 % (120 C, 4 hours) with 4,5 molecules of water: not more than 27,0 % (120 C, 4 hours) Acidity Fluoride Arsenic Lead Mercury Reducing substances Not more than 0,5 % of the dry matter expressed as lactic acid Not more than 30 mg/kg (expressed as fluorine) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg No reduction of Fehling's solution Passes test Passes test Soluble in water and practically insoluble in ethanol Between 6,0 and 8,0 (5 % solution) 212-406-7 Calcium dilactate; Calcium dilactate hydrate; 2-Hydroxypropanoic acid calcium salt (C3H5O2)2 CanH2O (n = 0 - 5) 218,22 (anhydrous) Content not less than 98 % on the anhydrous basis Almost odourless, white crystalline powder or granules
E 330 CITRIC ACID Synonyms Definition Citric acid is produced from lemon or pineapple juice, by fermentation of carbohydrate solutions or other suitable media using Candida spp. or non-toxicogenic strains of Aspergillus niger
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Einecs Chemical name Chemical formula
201-069-1 Citric acid; 2-Hydroxy-1,2,3-propanetricarboxylic acid; -Hydroxytri carballylic acid (a) C6H8O7 (anhydrous) (b) C6H8O7H2O (monohydrate)
Molecular weight
(a) 192,13 (anhydrous) (b) 210,15 (monohydrate)
Assay
Citric acid may be anhydrous or it may contain 1 molecule of water. Citric acid contains not less than 99,5 % of C6H8O7, calculated on the anhydrous basis Citric acid is a white or colourless, odourless, crystalline solid, having a strongly acid taste. The monohydrate effloresces in dry air
Description Identification Solubility Purity Water content
Very soluble in water; freely soluble in ethanol; soluble in ether
Anhydrous citric acid contains not more than 0,5 % water; citric acid monohydrate contains not more than 8,8 % water (Karl Fischer method) Not more than 0,05 % after calcination at 800 25 C Not more than 1 mg/kg Not more than 0,5 mg/kg Not more than 1 mg/kg Not more than 100 mg/kg, expressed as oxalic acid, after drying Heat 1 g of powdered sample with 10 ml of 98 % minimum sulphuric acid in a water bath at 90 C in the dark for one hour. Not more than a pale brown colour should be produced (Matching Fluid K)
Sulphated ash Arsenic Lead Mercury Oxalates Readily carbonisable substances
E 331 (i) MONOSODIUM CITRATE Synonyms Definition Einecs Chemical name Chemical formula 242-734-6 Monosodium citrate; Monosodium salt of 2-hydroxy-1,2,3-propanetri carboxylic acid (a) C6H7O7Na (anhydrous) (b) C6H7O7NaH2O (monohydrate) Molecular weight (a) 214,11 (anhydrous) (b) 232,23 (monohydrate) Assay Description Content not less than 99 % on the anhydrous basis Crystalline white powder or colourless crystals Monobasic sodium citrate
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L 83/107
Identification Test for citrate Test for sodium pH Purity Loss on drying anhydrous: not more than 1,0 % (140 C, 0,5 hour) monohydrate: not more than 8,8 % (180 C, 4 hours) Oxalates Arsenic Lead Mercury Not more than 100 mg/kg expressed as oxalic acid, after drying Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Passes test Passes test Between 3,5 and 3,8 (1 % aqueous solution)
E 331 (ii) DISODIUM CITRATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for citrate Test for sodium pH Purity Loss on drying Oxalates Arsenic Lead Mercury Not more than 13,0 % (180 C, 4 hours) Not more than 100 mg/kg expressed as oxalic acid, after drying Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Passes test Passes test Between 4,9 and 5,2 (1 % aqueous solution) 205-623-3 Disodium citrate; Disodium salt of 2-hydroxy-1,2,3-propanetricar boxylic acid; Disodium salt of citric acid with 1,5 molecules of water C6H6O7Na21,5H2O 263,11 Content not less than 99 % on the anhydrous basis Crystalline white powder or colourless crystals Dibasic sodium citrate
E 331 (iii) TRISODIUM CITRATE Synonyms Definition Einecs 200-675-3 Tribasic sodium citrate
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Chemical name
Trisodium citrate; Trisodium salt of 2-hydroxy-1,2,3-propanetricar boxylic acid; Trisodium salt of citric acid, in anhydrous, dihydrate or pentahydrate form Anhydrous: C6H5O7Na3 Hydrated: C6H5O7Na3nH2O (n = 2 or 5)
Chemical formula
Molecular weight
258,07 (anhydrous) 294,10 (hydrated n = 2) 348,16 (hydrated n = 5)
Assay Description Identification Test for citrate Test for sodium pH Purity Loss of drying
Not less than 99 % on the anhydrous basis Crystalline white powder or colourless crystals
Passes test Passes test Between 7,5 and 9,0 (5 % aqueous solution)
Anhydrous: not more than 1,0 % (180 C, 18 hours) Dihydrate: 10,0 to 13,0 % (180 C, 18 hours) Pentahydrate: not more than 30,3 % (180 C, 4 hours)
Oxalates Arsenic Lead Mercury
Not more than 100 mg/kg expressed as oxalic acid, after drying Not more than 1 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 332 (i) MONOPOTASSIUM CITRATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for citrate Test for potassium pH Passes test Passes test Between 3,5 and 3,8 (1 % aqueous solution) 212-753-4 Monopotassium citrate; Monopotassium salt of 2-hydroxy-1,2,3propanetricarboxylic acid; Anhydrous monopotassium salt of citric acid C6H7O7K 230,21 Content not less than 99 % on the anhydrous basis White, hygroscopic, granular powder or transparent crystals Monobasic potassium citrate
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L 83/109
Purity Loss on drying Oxalates Arsenic Lead Mercury Not more than 1,0 % (180 C, 4 hours) Not more than 100 mg/kg expressed as oxalic acid, after drying Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 332 (ii) TRIPOTASSIUM CITRATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for citrate Test for potassium pH Purity Loss on drying Oxalates Arsenic Lead Mercury Not more than 6,0 % (180 C, 4 hours) Not more than 100 mg/kg (expressed as oxalic acid, after drying) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Passes test Passes test Between 7,5 and 9,0 (5 % aqueous solution) 212-755-5 Tripotassium citrate; Tripotassium salt of 2-hydroxy-1,2,3-propanetri carboxylic acid; Monohydrated tripotassium salt of citric acid C6H5O7K3H2O 324,42 Content not less than 99 % on the anhydrous basis White, hygroscopic, granular powder or transparent crystals Tribasic potassium citrate
E 333 (i) MONOCALCIUM CITRATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Monocalcium citrate; Monocalcium salt of 2-hydroxy-1,2,3-propanetri carboxylic acid; Monohydrate monocalcium salt of citric acid (C6H7O7)2CaH2O 440,32 Content not less than 97,5 % on the anhydrous basis Monobasic calcium citrate
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Description Identification Test for citrate Test for calcium pH Purity Loss on drying Oxalates Fluoride Arsenic Lead Mercury Aluminium
Fine white powder
Passes test Passes test Between 3,2 and 3,5 (1 % aqueous solution)
Not more than 7,0 % (180 C, 4 hours) Not more than 100 mg/kg (expressed as oxalic acid, after drying) Not more than 30 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 30 mg/kg (only if added to food for infants and young children) Not more than 200 mg/kg (for all uses except food for infants and young children)
Carbonates
Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles
E 333 (ii) DICALCIUM CITRATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for citrate Test for calcium Purity Loss on drying Oxalates Fluoride Arsenic Lead Mercury Not more than 20,0 % (180 C, 4 hours) Not more than 100 mg/kg (expressed as oxalic acid, after drying) Not more than 30 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Passes test Passes test Dicalcium citrate; Dicalcium salt of 2-hydroxy-1,2,3-propanetricar boxylic acid; Trihydrated dicalcium salt of citric acid (C6H7O7)2Ca23H2O 530,42 Not less than 97,5 % on the anhydrous basis Fine white powder Dibasic calcium citrate
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L 83/111
Aluminium
Not more than 30 mg/kg (only if added to food for infants and young children) Not more than 200 mg/kg (for all uses except food for infants and young children)
Carbonates
Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles
E 333 (iii) TRICALCIUM CITRATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for citrate Test for calcium Purity Loss on drying Oxalates Fluoride Arsenic Lead Mercury Aluminium Not more than 14,0 % (180 C, 4 hours) Not more than 100 mg/kg (expressed as oxalic acid, after drying) Not more than 30 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 30 mg/kg (only if added to food for infants and young children) Not more than 200 mg/kg (for all uses except food for infants and young children) Carbonates Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles Passes test Passes test 212-391-7 Tricalcium citrate; Tricalcium salt of 2-hydroxy-1,2,3-propanetricar boxylic acid; Tetrahydrated tricalcium salt of citric acid (C6H6O7)2Ca34H2O 570,51 Not less than 97,5 % on the anhydrous basis Fine white powder Tribasic calcium citrate
E 334 L(+)-TARTARIC ACID, TARTARIC ACID Synonyms Definition Einecs 201-766-0
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Chemical name Chemical formula Molecular weight Assay Description Identification Melting range Test for tartrate Specific rotation Purity Loss on drying Sulphated ash Lead Mercury Oxalates
L-tartaric acid; L-2,3-dihydroxybutanedioic acid; d-,-dihydroxy succinic acid C4H6O6 150,09 Content not less than 99,5 % on the anhydrous basis Colourless or translucent crystalline solid or white crystalline powder
Between 168 C and 170 C Passes test []D20 between + 11,5 and + 13,5 (20 % w/v aqueous solution)
Not more than 0,5 % (over P2O5, 3 hours) Not more than 1 000 mg/kg (after calcination at 800 25 C) Not more than 2 mg/kg Not more than 1 mg/kg Not more than 100 mg/kg expressed as oxalic acid, after drying
E 335 (i) MONOSODIUM TARTRATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for tartrate Test for sodium Purity Loss on drying Oxalates Arsenic Lead Mercury Not more than 10,0 % (105 C, 4 hours) Not more than 100 mg/kg (expressed as oxalic acid, after drying) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Passes test Passes test Monosodium salt of L-2,3-dihydroxybutanedioic acid; Monohydrated monosodium salt of L-(+)-tartaric acid C4H5O6NaH2O 194,05 Content not less than 99 % on the anhydrous basis Transparent colourless crystals Monosodium salt of L-(+)-tartaric acid
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E 335 (ii) DISODIUM TARTRATE Synonyms Definition Einecs Chemical name 212-773-3 Disodium L-tartrate; Disodium (+)-tartrate; Disodium salt of (+)-2,3dihydroxybutanedioic acid; Dihydrated disodium salt of L-(+)-tartaric acid C4H4O6Na22H2O 230,8 Content not less than 99 % on the anhydrous basis Transparent, colourless crystals
Chemical formula Molecular weight Assay Description Identification Test for tartrate Test for sodium Solubility pH Purity Loss on drying Oxalates Arsenic Lead Mercury
Passes test Passes test 1 gram is insoluble in 3 ml of water. Insoluble in ethanol Between 7,0 and 7,5 (1 % aqueous solution)
Not more than 17,0 % (150 C, 4 hours) Not more than 100 mg/kg (expressed as oxalic acid, after drying) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 336 (i) MONOPOTASSIUM TARTRATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for tartrate Test for potassium Melting point pH Passes test Passes test 230 C 3,4 (1 % aqueous solution) Anhydrous monopotassium salt of L-(+)-tartaric acid; Monopotassium salt of L-2,3-dihydroxybutanedioic acid C4H5O6K 188,16 Content not less than 98 % on the anhydrous basis White crystalline or granulated powder Monobasic potassium tartrate
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Purity Loss on drying Oxalates Arsenic Lead Mercury Not more than 1,0 % (105 C, 4 hours) Not more than 100 mg/kg (expressed as oxalic acid, after drying) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 336 (ii) DIPOTASSIUM TARTRATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for tartrate Test for potassium pH Purity Loss on drying Oxalates Arsenic Lead Mercury Not more than 4,0 % (150 C, 4 hours) Not more than 100 mg/kg (expressed as oxalic acid, after drying) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Passes test Passes test Between 7,0 and 9,0 (1 % aqueous solution) 213-067-8 Dipotassium salt of L-2,3-dihydroxybutanedioic acid; Dipotassium salt with half a molecule of water of L-(+)-tartaric acid C4H4O6K2H2O 235,2 Content not less than 99 % on the anhydrous basis White crystalline or granulated powder Dibasic potassium tartrate
E 337 POTASSIUM SODIUM TARTRATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 206-156-8 Potassium sodium salt of L-2,3-dihydroxybutanedioic acid; Potassium sodium L-(+)-tartrate C4H4O6KNa4H2O 282,23 Content not less than 99 % on the anhydrous basis Potassium sodium L-(+)-tartrate; Rochelle salt; Seignette salt
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L 83/115
Description Identification Test for tartrate Test for potassium Test for sodium Solubility Melting range pH Purity Loss on drying Oxalates Arsenic Lead Mercury
Colourless crystals or white crystalline powder
Passes test Passes test Passes test 1 gram is soluble in 1 ml of water, insoluble in ethanol 70-80 C Between 6,5 and 8,5 (1 % aqueous solution)
Not more than 26,0 % and not less than 21,0 % (150 C, 3 hours) Not more than 100 mg/kg (expressed as oxalic acid, after drying) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 338 PHOSPHORIC ACID Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 231-633-2 Phosphoric acid H3PO4 98,00 Content not less than 67,0 % and not more than 85,7 %. Phosphoric acid is commercially available as an aqueous solution at variable concentrations. Clear, colourless, viscous liquid Orthophosphoric acid; Monophosphoric acid
Description Identification Test for acid Test for phosphate Purity Volatile acids Chlorides Nitrates Sulphates Fluoride Arsenic
Not more than 10 mg/kg (as acetic acid) Not more than 200 mg/kg (expressed as chlorine) Not more than 5 mg/kg (as NaNO3) Not more than 1 500 mg/kg (as CaSO4) Not more than 10 mg/kg (expressed as fluorine) Not more than 1 mg/kg
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Cadmium Lead Mercury
E 339 (i) MONOSODIUM PHOSPHATE Synonyms Monosodium monophosphate; Acid monosodium monophosphate; Monosodium orthophosphate; Monobasic sodium phosphate; Sodium dihydrogen monophosphate
Definition Einecs Chemical name Chemical formula 231-449-2 Sodium dihydrogen monophosphate Anhydrous: NaH2PO4 Monohydrate: NaH2PO4 H2O Dihydrate: NaH2PO4 2H2O Molecular weight Anhydrous: 119,98 Monohydrate: 138,00 Dihydrate: 156,01 Assay After drying at 60 C for one hour and then at 105 C for four hours, contains not less than 97 % of NaH2PO4 P2O5 content between 58,0 % and 60,0 % on the anhydrous basis Description Identification Test for sodium Test for phosphate Solubility pH Purity Loss on drying The anhydrous salt loses not more than 2,0 %, the monohydrate not more than 15,0 %, the dihydrate not more than 25 % (60 C, 1 hour then 105 C, 4 hours) Not more than 0,2 % on the anhydrous basis Not more than 10 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Passes test Passes test Freely soluble in water. Insoluble in ethanol or ether Between 4,1 and 5,0 (1 % solution) A white odourless, slightly deliquescent powder, crystals or granules
Water insoluble matter Fluoride Arsenic Cadmium Lead Mercury
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E 339 (ii) DISODIUM PHOSPHATE Synonyms Definition Einecs Chemical name Chemical formula 231-448-7 Disodium hydrogen monophosphate; Disodium hydrogen orthophos phate Anhydrous:Na2HPO4 Hydrate: Na2HPO4 nH2O (n = 2, 7 or 12) Molecular weight Assay 141,98 (anhydrous) After drying at 40 C for three hours and subsequently at 105 C for five hours, contains not less than 98 % of Na2HPO4 P2O5 content between 49 % and 51 % on the anhydrous basis Description Anhydrous disodium hydrogen phosphate is a white, hygroscopic, odourless powder. Hydrated forms available include the dihydrate: a white crystalline, odourless solid; the heptahydrate: white, odourless, efflorescent crystals or granular powder; and the dodecahydrate: white, efflorescent, odourless powder or crystals Disodium monophosphate; Secondary sodium phosphate; Disodium orthophosphate;
Identification Test for sodium Test for phosphate Solubility pH Purity Loss on drying The anhydrous salt loses not more than 5,0 %, the dihydrate not more than 22,0 %, the heptahydrate not more than 50,0 %, the dodecahydrate not more than 61,0 % (40 C, 3 hours then 105 C, 5 hours) Not more than 0,2 % on the anhydrous basis Not more than 10 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Passes test Passes test Freely soluble in water. Insoluble in ethanol Between 8,4 and 9,6 (1 % solution)
E 339 (iii) TRISODIUM PHOSPHATE Synonyms Definition Sodium phosphate; Tribasic sodium phosphate; Trisodium orthophos phate Trisodium phosphate is obtained from aqueous solutions and cryst allises in the anhydrous form and with 1/2, 1, 6, 8 or 12 H2O. The dodecahydrate always crystallises from aqueous solutions with an excess of sodium hydroxide. It contains molecule of NaOH
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231-509-8 Trisodium monophosphate; Trisodium phosphate; Trisodium ortho phosphate Anhydrous: Na3PO4 Hydrated: Na3PO4 nH2O (n = 1/2, 1, 6, 8, or 12)
Molecular weight Assay
163,94 (anhydrous) Sodium phosphate anhydrous and the hydrated forms, with the exception of the dodecahydrate, contain not less than 97,0 % of Na3PO4 calculated on the dried basis. Sodium phosphate dodecahydrate contains not less than 92,0 % of Na3PO4 calculated on the ignited basis P2O5 content between 40,5 % and 43,5 % on the anhydrous basis
Description Identification Test for sodium Test for phosphate Solubility pH Purity Loss on ignition
White odourless crystals, granules or crystalline powder
Passes test Passes test Freely soluble in water. Insoluble in ethanol Between 11,5 and 12,5 (1 % solution)
When dried at 120 C for two hours and then ignited at about 800 C for 30 minutes, the losses in weight are as follows: anhydrous not more than 2,0 %, monohydrate not more than 11,0 %, dodecahydrate: between 45,0 % and 58,0 % Not more than 0,2 % on the anhydrous basis Not more than 10 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 340 (i) MONOPOTASSIUM PHOSPHATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 231-913-4 Potassium dihydrogen phosphate; Monopotassium dihydrogen ortho phosphate; Monopotassium dihydrogen monophosphate KH2PO4 136,09 Content not less than 98,0 % after drying at 105 C for four hours P2O5 content between 51,0 % and 53,0 % on the anhydrous basis Monobasic potassium phosphate; Monopotassium monophosphate; Mono potassium orthophosphate
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Description Identification Test for potassium Test for phosphate Solubility pH Purity Loss on drying Water insoluble matter Fluoride Arsenic Cadmium Lead Mercury
Odourless, colourless crystals or white granular or crystalline powder
Passes test Passes test Freely soluble in water. Insoluble in ethanol Between 4,2 and 4,8 (1 % solution)
Not more than 2,0 % (105 C, 4 hours) Not more than 0,2 % on the anhydrous basis Not more than 10 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 340 (ii) DIPOTASSIUM PHOSPHATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 231-834-5 Dipotassium hydrogen monophosphate; Dipotassium hydrogen phos phate; Dipotassium hydrogen orthophosphate K2HPO4 174,18 Content not less than 98 % after drying at 105 C for four hours P2O5 content between 40,3 % and 41,5 % on the anhydrous basis Description Identification Test for potassium Test for phosphate Solubility pH Purity Loss on drying Water insoluble matter Fluoride Not more than 2,0 % (105 C, 4 hours) Not more than 0,2 % (on the anhydrous basis) Not more than 10 mg/kg (expressed as fluorine) Passes test Passes test Freely soluble in water. Insoluble in ethanol Between 8,7 and 9,4 (1 % solution) Colourless or white granular powder, crystals or masses; deliquescent substance, hygroscopic Dipotassium monophosphate; Secondary potassium phosphate; Dipot assium orthophosphate; Dibasic potassium phosphate
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E 340 (iii) TRIPOTASSIUM PHOSPHATE Synonyms Definition Einecs Chemical name Chemical formula 231-907-1 Tripotassium monophosphate; Tripotassium phosphate; Tripotassium orthophosphate Anhydrous: K3PO4 Hydrated: K3PO4 nH2O (n = 1 or 3) Molecular weight Assay 212,27 (anhydrous) Content not less than 97 % calculated on the ignited basis P2O5 content between 30,5 % and 34,0 % on the ignited basis Description Identification Test for potassium Test for phosphate Solubility pH Purity Loss on ignition Anhydrous: not more than 3,0 %; hydrated: not more than 23,0 % (determined by drying at 105 C for one hour and then ignite at about 800 C 25 C for 30 minutes) Not more than 0,2 % (on the anhydrous basis) Not more than 10 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Passes test Passes test Freely soluble in water. Insoluble in ethanol Between 11,5 and 12,3 (1 % solution) Colourless or white, odourless hygroscopic crystals or granules. Hydrated forms available include the monohydrate and trihydrate Tribasic potassium phosphate; Tripotassium orthophosphate
E 341 (i) MONOCALCIUM PHOSPHATE Synonyms Definition Einecs 231-837-1 Monobasic calcium phosphate; Monocalcium orthophosphate
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Chemical name Chemical formula
Calcium dihydrogen phosphate Anhydrous: Ca(H2PO4)2 Monohydrate: Ca(H2PO4)2 H2O
Molecular weight
234,05 (anhydrous) 252,08 (monohydrate)
Assay
Content not less than 95 % on the dried basis P2O5 content between 55,5 % and 61,1 % on the anhydrous basis
Description Identification Test for calcium Test for phosphate CaO content
Granular powder or white, deliquescent crystals or granules
Passes test Passes test Between 23,0 % and 27,5 % (anhydrous) Between 19,0 % and 24,8 % (monohydrate)
Purity Loss on drying Anhydrous: not more than 14 % (105 C, 4 hours) Monohydrate: not more than 17,5 % (105 C, 4 hours) Loss on ignition Anhydrous: not more than 17,5 % (after ignition at 800 C 25 C for 30 minutes) Monohydrate: not more than 25,0 % (determined by drying at 105 C for one hour, then ignite at 800 C 25 C for 30 minutes) Fluoride Arsenic Cadmium Lead Mercury Aluminium Not more than 30 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 70 mg/kg (only if added to food for infants and young children) Not more than 200 mg/kg (for all uses except food for infants and young children)
E 341 (ii) DICALCIUM PHOSPHATE Synonyms Definition Einecs Chemical name Chemical formula 231-826-1 Calcium monohydrogen phosphate; Calcium hydrogen orthophosphate; Secondary calcium phosphate Anhydrous: CaHPO4 Dihydrate: CaHPO4 2H2O Dibasic calcium phosphate; Dicalcium orthophosphate
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Molecular weight
136,06 (anhydrous) 172,09 (dihydrate)
Assay
Dicalcium phosphate, after drying at 200 C for three hours, contains not less than 98 % and not more than the equivalent of 102 % of CaHPO4 P2O5 content between 50,0 % and 52,5 % on the anhydrous basis
Description Identification Test for calcium Test for phosphate Solubility Purity Loss on ignition
White crystals or granules, granular powder or powder
Passes test Passes test Sparingly soluble in water. Insoluble in ethanol
Not more than 8,5 % (anhydrous), or 26,5 % (dihydrate) after ignition at 800 C 25 C for 30 minutes Not more than 50 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 100 mg/kg for the anhydrous form and not more than 80 mg/kg for the dihydrated form (only if added to food for infants and young children) Not more than 600 mg/kg for the anhydrous form and not more than 500 mg/kg for the dihydrated form (for all uses except food for infants and young children). This applies until 31 March 2015. Not more than 200 mg/kg for the anhydrous form and the dihydrated form (for all uses except food for infants and young children). This applies from 1 April 2015.
Fluoride Arsenic Cadmium Lead Mercury Aluminium
E 341 (iii) TRICALCIUM PHOSPHATE Synonyms Calcium phosphate, tribasic; Calcium orthophosphate; Pentacalcium hydroxy monophosphate; Calcium hydroxyapatite Tricalcium phosphate consists of a variable mixture of calcium phos phates obtained from neutralisation of phosphoric acid with calcium hydroxide and having the approximate composition of 10CaO3P2O5 H2O 235-330-6 (Pentacalcium hydroxy monophosphate) 231-840-8 (Calcium orthophosphate) Chemical name Chemical formula Molecular weight Pentacalcium hydroxy monophosphate; Tricalcium monophosphate Ca5(PO4)3 OH or Ca3(PO4)2 502 or 310
Definition
Einecs
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Assay
Content not less than 90 % calculated on the ignited basis P2O5 content between 38,5 % and 48,0 % on the anhydrous basis
Description Identification Test for calcium Test for phosphate Solubility Purity Loss on ignition Fluoride Arsenic Cadmium Lead Mercury Aluminium
A white, odourless powder which is stable in air
Passes test Passes test Practically insoluble in water; insoluble in ethanol, soluble in dilute hydrochloric and nitric acid
Not more than 8 % after ignition at 800 C 25 C for 0,5 hour Not more than 50 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 150 mg/kg (only if added to food for infants and young children) Not more than 500 mg/kg (for all uses except food for infants and young children). This applies until 31 March 2015 Not more than 200 mg/kg (for all uses except food for infants and young children). This applies from 1 April 2015.
E 343 (i) MONOMAGNESIUM PHOSPHATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for magnesium Test for phosphate MgO content Passes test Passes test Not less than 21,5 % after ignition or at an anhydrous basis (105 C, 4 hours) 236-004-6 Monomagnesiumdihydrogenmonophosphate Mg(H2PO4)2 nH2O (where n = 0 to 4) 218,30 (anhydrous) Not less than 51,0 % after ignition calculated as P2O5 at the ignited basis (800 C 25 C for 30 minutes) White, odourless, crystalline powder, slightly soluble in water Magnesiumdihydrogenphosphate; Magnesiumphosphate, monobasic; Monomagnesium orthophosphate
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Purity Fluoride Arsenic Lead Cadmium Mercury Not more than 10 mg/kg (as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 343 (ii) DIMAGNESIUM PHOSPHATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for magnesium Test for phosphate MgO content Purity Fluoride Arsenic Lead Cadmium Mercury Not more than 10 mg/kg (as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Passes test Passes test Not less than 33,0 % calculated on the anhydrous basis (105 C, 4 hours) 231-823-5 Dimagnesiummonohydrogenmonophosphate MgHPO4 nH2O (where n = 0-3) 120,30 (anhydrous) Not less than 96 % after ignition (800 C 25 C for 30 minutes) White, odourless, crystalline powder, slightly soluble in water Magnesiumhydrogenphosphate; Magnesiumphosphate, dibasic; Dimagnesium orthophosphate; Secondary magnesiumphosphate
E 350 (i) SODIUM MALATE Synonyms Definition Einecs Chemical name Chemical formula Disodium DL-malate; disodium salt of hydroxybutanedioic acid Hemihydrate: C4H4Na2O5 H2O Trihydrate: C4H4Na2O5 3H2O Sodium salt of malic acid
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Molecular weight
Hemihydrate: 187,05 Trihydrate: 232,10
Assay Description Identification Test for 1,2-dicarboxylic acid Test for sodium Azo dye formation Solubility Purity Loss on drying
Content not less than 98,0 % on the anhydrous basis White crystalline powder or lumps
Passes test Passes test Positive Freely soluble in water
Hemihydrate: Not more than 7,0 % (130 C, 4 hours) Trihydrate: 20,5-23,5 % (130 C, 4 hours)
Alkalinity Fumaric acid Maleic acid Arsenic Lead Mercury
Not more than 0,2 % as Na2CO3 Not more than 1,0 % Not more than 0,05 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 350 (ii) SODIUM HYDROGEN MALATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for 1,2-dicarboxylic acid Test for sodium Azo dye formation Purity Loss on drying Maleic acid Fumaric acid Not more than 2,0 % (110 C, 3 hours) Not more than 0,05 % Not more than 1,0 % Passes test Passes test Positive Monosodium DL-malate; monosodium 2-DL-hydroxy succinate C4H5NaO5 156,07 Content not less than 99,0 % on the anhydrous basis White powder Monosodium salt of DL-malic acid
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E 351 POTASSIUM MALATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for 1,2-dicarboxylic acid Test for potassium Azo dye formation Purity Alkalinity Fumaric acid Maleic acid Arsenic Lead Mercury Not more than 0,2 % as K2CO3 Not more than 1,0 % Not more than 0,05 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Passes test Passes test Positive Dipotassium DL-malate; dipotassium salt of hydroxybutanedioic acid C4H4K2O5 210,27 Content not less than 59,5 % Colourless or almost colourless aqueous solution Potassium salt of malic acid
E 352 (i) CALCIUM MALATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for malate Test 1,2-dicarboxylic acid Passes test Passes test Calcium DL-malate; calcium--hydroxysuccinate; calcium salt of hydro xybutanedioic acid C4H5CaO5 172,14 Content not less than 97,5 % on the anhydrous basis White powder Calcium salt of malic acid
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Test for calcium Azo dye formation Solubility Purity Loss on drying Alkalinity Maleic acid Fumaric acid Fluoride Arsenic Lead Mercury
Passes test Positive Slightly soluble in water
Not more than 2 % (100 C, 3 hours) Not more than 0,2 % as CaCO3 Not more than 0,05 % Not more than 1,0 % Not more than 30 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 352 (ii) CALCIUM HYDROGEN MALATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for 1,2-dicarboxylic acid Test for calcium Azo dye formation Purity Loss on drying Maleic acid Fumaric acid Fluoride Arsenic Lead Mercury Not more than 2,0 % (110 C, 3 hours) Not more than 0,05 % Not more than 1,0 % Not more than 30 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Passes test Passes test Positive Content not less than 97,5 % on the anhydrous basis White powder Monocalcium DL-malate; monocalcium 2-DL-hydroxysuccinate (C4H5O5)2Ca Monocalcium salt of DL-malic acid
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E 353 METATARTARIC ACID Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Identification test Very soluble in water and ethanol Place a sample of 1 to 10 mg of this substance in a test tube with 2 ml of concentrated sulphuric acid and 2 drops of sulpho-resorcinol reagent. When heated to 150 C, an intense violet coloration appears Not less than 99,5 % Crystalline or powder form with a white or yellowish colour. Very deliquescent with a faint odour of caramel Metatartaric acid C4H6O6 Ditartaric acid
Purity Arsenic Lead Mercury Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 354 CALCIUM TARTRATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Slightly soluble in water. Solubility approximately 0,01 g/100 ml water (20 C). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids []D20 + 7,0 to + 7,4 (0,1 % in a 1N HCl solution) Between 6,0 and 9,0 (5 % slurry) Calcium L(+)-2,3-dihydroxybutanedioate di-hydrate C4H4CaO6 2H2O 224,18 Not less than 98,0 % Fine crystalline powder with a white or off-white colour L-Calcium tartrate
Specific rotation pH Purity Sulphates Arsenic Lead Mercury
Not more than 1 g/kg (as H2SO4) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
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E 355 ADIPIC ACID Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Melting range Solubility Purity Water Sulphated ash Arsenic Lead Mercury Not more than 0,2 % (Karl Fischer method) Not more than 20 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg 151,5-154,0 C Slightly soluble in water. Freely soluble in ethanol 204-673-3 Hexanedioic acid; 1,4-butanedicarboxylic acid C6H10O4 146,14 Content not less than 99,6 % White odourless crystals or crystalline powder
E 356 SODIUM ADIPATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Melting range Solubility Test for sodium Purity Water content Arsenic Lead Mercury Not more than 3 % (Karl Fischer) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg 151-152 C (for adipic acid) Approximately 50 g/100 ml water (20 C) Passes test 231-293-5 Sodium adipate C6H8Na2O4 190,11 Content not less than 99,0 % (on anhydrous basis) White odourless crystals or crystalline powder
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E 357 POTASSIUM ADIPATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Melting range Solubility Test for potassium Purity Water Arsenic Lead Mercury Not more than 3 % (Karl Fischer) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg 151-152 C (for adipic acid) Approximately 60 g/100 ml water (20 C) Passes test 242-838-1 Potassium adipate C6H8K2O4 222,32 Content not less than 99,0 % (on anhydrous basis) White odourless crystals or crystalline powder
E 363 SUCCINIC ACID Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Melting range Purity Residue on ignition Arsenic Lead Mercury Not more than 0,025 % (800 C, 15 min) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg 185,0-190,0 C 203-740-4 Butanedioic acid C4H6O4 118,09 Content no less than 99,0 % Colourless or white, odourless crystals
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E 380 TRIAMMONIUM CITRATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for ammonium Test for citrate Solubility Purity Oxalate Arsenic Lead Mercury Not more than 0,04 % (as oxalic acid) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Passes test Passes test Freely soluble in water 222-394-5 Triammonium salt of 2-hydroxypropan-1,2,3-tricarboxylic acid C6H17N3O7 243,22 Content not less than 97,0 % White to off-white crystals or powder Tribasic ammonium citrate
E 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATE Synonyms Definition Einecs Chemical name 200-529-9 N,N-1,2-Ethanediylbis [N-(carboxymethyl)-glycinate] [(4-)-O,O,ON,ON] calciate(2)-disodium; Calcium disodium ethylenediaminetetra acetate; Calcium disodium (ethylenedinitrilo)tetra acetate C10H12O8CaN2Na22H2O 410,31 Content not less than 97 % on the anhydrous basis White, odourless crystalline granules or white to nearly white powder, slightly hygroscopic Calcium disodium EDTA; Calcium disodium edetate
Chemical formula Molecular weight Assay Description Identification Test for sodium Test for calcium Chelating activity to metal ions pH Purity Water content
Passes test Passes test Positive Between 6,5 and 7,5 (1 % solution)
5 to 13 % (Karl Fischer method)
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E 392 EXTRACTS OF ROSEMARY Synonyms Definition Extract of rosemary leaf (antioxidant) Extracts of rosemary contain several components, which have been proven to exert antioxidative functions. These components belong mainly to the classes of phenolic acids, flavonoids, diterpenoids. Besides the antioxidant compounds, the extracts can also contain triterpenes and organic solvent extractable material specifically defined in the following specification. 283-291-9 Rosemary extract (Rosmarinus officinalis) Rosemary leaf extract antioxidant is prepared by extraction of the leaves of Rosmarinus officinalis using a food approved solvent system. Extracts may then be deodorised and decolourised. Extracts may be standardised.
Einecs Chemical name Description
Identification Reference antioxidative compounds: phenolic diterpenes Reference key volatiles Density Solubility Purity Loss of drying Arsenic Lead <5% Not more than 3 mg/kg Not more than 2 mg/kg Carnosic acid (C20H28O4) and Carnosol (C20H26O4) (which comprise not less than 90 % of the total phenolic diterpenes) Borneol, Bornyl Acetate, Camphor, 1,8-Cineol, Verbenone > 0,25 g/ml Insoluble in water
1 Extracts of rosemary produced from dried rosemary leaves by acetone extraction. Description Extracts of rosemary are produced from dried rosemary leaves by acetone extraction, filtration, purification and solvent evaporation, followed by drying and sieving to obtain a fine powder or a liquid.
Identification Content of compounds reference antioxidative 10 % w/w, expressed as the total of carnosic acid and carnosol (Total % w/w of carnosic acid and carnosol) 15 (% w/w of reference key volatiles)* (* as a percentage of total volatiles in the extract, measured by Gas Chromatography Mass Spectrometry Detection, GC-MSD) Purity Residual solvents Acetone: Not more than 500 mg/kg
Antioxidant/Volatiles Ratio
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2 Extracts of rosemary prepared by extraction of dried rosemary leaves by means of supercritical carbon dioxide. Description Extracts of rosemary produced from dried rosemary leaves extracted by means of supercritical carbon dioxide with a small amount of ethanol as entrainer.
Identification Content of compounds reference antioxidative 13 % w/w, expressed as the total of carnosic acid and carnosol
(Total % w/w of carnosic acid and carnosol) 15 (% w/w of reference key volatiles)* (* as a percentage of total volatiles in the extract, measured by Gas Chromatography Mass Spectrometry Detection, GC-MSD)
Purity Residual solvents Ethanol: not more than 2 %
3 Extracts of rosemary prepared from a deodorised ethanolic extract of rosemary. Description Extracts of rosemary which are prepared from a deodorised ethanolic extract of rosemary. The extracts may be further purified, for example by treatment with active carbon and/or molecular distillation. The extracts may be suspended in suitable and approved carriers or spray dried.
Purity Residual solvents Ethanol: not more than 500 mg/kg
4 Extracts of rosemary decolourised and deodorised, obtained by a two-step extraction using hexane and ethanol. Description Extracts of rosemary which are prepared from a deodorised ethanolic extract of rosemary, undergone a hexane extraction. The extract may be further purified, for example by treatment with active carbon and/or molecular distillation. They may be suspended in suitable and approved carriers or spray dried.
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Purity Residual solvents Hexane: not more than 25 mg/kg Ethanol: not more than 500 mg/kg
E 400 ALGINIC ACID Synonyms Definition Linear glycuronoglycan consisting mainly of -(1-4) linked D-mannuronic and -(1-4) linked L-guluronic acid units in pyranose ring form. Hydrophilic colloidal carbohydrate extracted by the use of dilute alkali from strains of various species of brown seaweeds (Phaeo phyceae) 232-680-1
(C6H8O6)n 10 000-600 000 (typical average) Alginic acid yields, on the anhydrous basis, not less than 20 % and not more than 23 % of carbon dioxide (CO2), equivalent to not less than 91 % and not more than 104,5 % of alginic acid (C6H8O6)n (calculted on equivalent weight basis of 200) Alginic acid occurs in filamentous, grainy, granular and powdered forms. It is a white to yellowish brown and nearly odourless
Description
Identification Solubility Insoluble in water and organic solvents, slowly soluble in solutions of sodium carbonate, sodium hydroxide and trisodium phosphate To a 0,5 % solution of the sample in 1 M sodium hydroxide solution add one fifth of its volume of a 2,5 % solution of calcium chloride. A voluminous, gelatinous precipitate is formed. This test distinguishes alginic acid from acacia gum, sodium carboxymethyl cellulose, carboxy methyl starch, carrageenan, gelatin, gum ghatti, karaya gum, locust bean gum, methyl cellulose and tragacanth gum. To a 0,5 % solution of the sample in 1 M sodium hydroxide solution add one half of its volume of a saturated solution of ammonium sulphate. No precipitate is formed. This test distinguishes alginic acid from agar, sodium carboxymethyl cellulose, carrageenan, de-esterified pectin, gelatin, locust bean gum, methyl cellulose and starch. Dissolve as completely as possible 0,01 g of the sample by shaking with 0,15 ml of 0,1 N sodium hydroxide and add 1 ml of acid ferric sulphate solution. Within 5 minutes a cherry-red colour develops that finally becomes deep purple. Between 2,0 and 3,5 (3 % suspension)
Calcium chloride precipitation test
Ammonium sulphate precipitation test
Colour reaction
pH
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Purity Loss on drying Sulphated ash Sodium hydroxide insoluble matter Formaldehyde Arsenic Lead Mercury Cadmium Microbiological criteria Total plate count Yeast and moulds Escherichia coli Salmonella spp. Not more than 5 000 colonies per gram Not more than 500 colonies per gram Absent in 5 g Absent in 10 g (1 M solution) Not more than 15 % (105 C, 4 hours) Not more than 8 % on the anhydrous basis Not more than 2 % on the anhydrous basis Not more than 50 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 401 SODIUM ALGINATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Sodium salt of alginic acid (C6H7NaO6)n 10 000-600 000 (typical average) Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 90,8 % and not more than 106,0 % of sodium alginate (calculated on equivalent weight basis of 222) Nearly odourless, white to yellowish fibrous or granular powder
Description Identification Test for sodium Test for alginic acid Purity Loss on drying Water insoluble matter Formaldehyde Arsenic Lead
Not more than 15 % (105 C, 4 hours) Not more than 2 % on the anhydrous basis Not more than 50 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg
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Mercury Cadmium Microbiological criteria Total plate count Yeast and moulds Escherichia coli Salmonella spp.
Not more than 5 000 colonies per gram Not more than 500 colonies per gram Absent in 5 g Absent in 10 g
E 402 POTASSIUM ALGINATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Potassium salt of alginic acid (C6H7KO6)n 10 000-600 000 (typical average) Yields, on the anhydrous basis, not less than 16,5 % and not more than 19,5 % of carbon dioxide corresponding to not less than 89,2 % and not more than 105,5 % of potassium alginate (calculated on an equivalent weight basis of 238) Nearly odourless, white to yellowish fibrous or granular powder
Description Identification Test for potassium Test for alginic acid Purity Loss on drying Water insoluble matter Formaldehyde Arsenic Lead Mercury Cadmium Microbiological criteria Total plate count Yeast and moulds Escherichia coli Salmonella spp.
Not more than 15 % (105 C, 4 hours) Not more than 2 % on the anhydrous basis Not more than 50 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
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E 403 AMMONIUM ALGINATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Ammonium salt of alginic acid (C6H11NO6)n 10 000-600 000 (typical average) Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 88,7 % and not more than 103,6 % ammonium alginate (calculated on an equivalent weight basis of 217) White to yellowish fibrous or granular powder
Description Identification Test for ammonium Test for alginic acid Purity Loss on drying Sulphated ash Water insoluble matter Formaldehyde Arsenic Lead Mercury Cadmium Microbiological criteria Total plate count Yeast and moulds Escherichia coli Salmonella spp.
Not more than 15 % (105 C, 4 hours) Not more than 7 % on the dried basis Not more than 2 % on the anhydrous basis Not more than 50 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 404 CALCIUM ALGINATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Calcium salt of alginic acid (C6H7Ca1/2O6)n 10 000-600 000 (typical average) Yields, on the anhydrous basis, not less than 18 % and not more than 21 % carbon dioxide corresponding to not less than 89,6 % and not more than 104,5 % of calcium alginate (calculated on an equivalent weight basis of 219) Calcium salt of alginate
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Description Identification Test for calcium Test for alginic acid Purity Loss on drying Formaldehyde Arsenic Lead Mercury Cadmium Microbiological criteria Total plate count Yeast and moulds Escherichia coli Salmonella spp.
Nearly odourless, white to yellowish fibrous or granular powder
Not more than 15,0 % (105 C, 4 hours) Not more than 50 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 405 PROPANE-1,2-DIOL ALGINATE Synonyms Definition Einecs Chemical name 1,2-Propanediol ester of alginic acid; varies in composition according to its degree of esterification and the percentage of free and neutralised carboxyl groups in the molecule (C9H14O7)n (esterified) 10 000-600 000 (typical average) Yields, on the anhydrous basis, not less than 16 % and not more than 20 % of carbon dioxide (CO2) Nearly odourless, white to yellowish brown fibrous or granular powder Hydroxypropyl alginate; 1,2-Propanediol ester of alginic acid; Propylene glycol alginate
Chemical formula Molecular weight Assay Description Identification Test for 1,2-propanediol Test for alginic acid Purity Loss on drying Total propane-1,2-diol content Free propane-1,2-diol content Water insoluble matter
Passes test (after hydrolysis) Passes test (after hydrolysis)
Not more than 20 % (105 C, 4 hours) Not less than 15 % and not more than 45 % Not more than 15 % Not more than 2 % on the anhydrous basis
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L 83/139
Formaldehyde Arsenic Lead Mercury Cadmium Microbiological criteria Total plate count Yeast and moulds Escherichia coli Salmonella spp.
Not more than 50 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 406 AGAR Synonyms Definition Gelose; Kanten, Bengal, Ceylon, Chinese or Japanese isinglass; Layor Carang Agar is a hydrophilic colloidal polysaccharide consisting mainly of galactose units with a regular alternation of L and D isomeric forms. These hexoses are alternately linked with alpha-1,3 and beta-1,4 bonds in the copolymer. On about every tenth D-galactopyranose unit one of the hydroxyl groups is esterified with sulphuric acid which is neutralised by calcium, magnesium, potassium or sodium. It is extracted from certain strains of marine algae of the families Gelidiaceae and Gracilariaceae and relevant red algae of the class Rhodophyceae 232-658-1
Einecs Chemical name Chemical formula Molecular weight Assay Description
The threshold gel concentration should not be higher than 0,25 % Agar is odourless or has a slight characteristic odour. Unground agar usually occurs in bundles consisting of thin, membranous, agglutinated strips, or in cut, flaked or granulated forms. It may be light yellowishorange, yellowish-grey to pale yellow, or colourless. It is tough when damp, brittle when dry. Powdered agar is white to yellowish-white or pale yellow. When examined in water under a microscope, agar powder appears more transparent. In chloral hydrate solution, the powdered agar appears more transparent than in water, more or less granular, striated, angular and occasionally contains frustules of diatoms. Gel strength may be standardised by the addition of dextrose and maltod extrines or sucrose
Identification Solubility Purity Loss on drying Ash Acid-insoluble ash (insoluble in approximately 3N Hydrochloric acid) Not more than 22 % (105 C, 5 hours) Not more than 6,5 % on the anhydrous basis determined at 550 C Not more than 0,5 % determined at 550 C on the anhydrous basis Insoluble in cold water; soluble in boiling water
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Insoluble matter (after stirring for 10 minutes in hot water) Starch
Not more than 1,0 %
Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. No blue colour is produced Dissolve about 1 g of agar in 100 ml of boiling water and allow to cool of about 50 C. To 5 ml of the solution add 5 ml of trinitrophenol solution (1 g of anhydrous trinitrophenol/100 ml of hot water). No turbidity appears within 10 minutes Place 5 g to agar in a 100 ml graduated cylinder, fill to the mark with water, mix and allow to stand at about 25 C for 24 hours. Pour the contents of the cylinder through moistened glass wool, allowing the water to drain into a second 100 ml graduated cylinder. Not more than 75 ml of water is obtained Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
Gelatin and other proteins
Water absorption
Arsenic Lead Mercury Cadmium Microbiological criteria Total plate count Yeast and moulds Escherichia coli Salmonella spp.
E 407 CARRAGEENAN Synonyms Products of commerce are sold under different names such as: Irish moss gelose; Eucheuman (from Eucheuma spp.); Iridophycan (from Iridaea spp.); Hypnean (from Hypnea spp.); Furcellaran or Danish agar (from Furcellaria fastigiata); Carrageenan (from Chondrus and Gigartina spp.) Definition Carrageenan is obtained by extraction with water or dilute aqueous alkali of strains of seaweeds of Gigartinaceae, Solieriaceae, Hypneaceae and Furcellariaceae, families of the class Rhodophyceae (red seaweeds). Carrageenan consists chiefly of the potassium, sodium, magnesium and calcium sulphate esters of galactose and 3,6-anhydrogalactose poly sacharide. These hexoses are alternately linked -1,3 and -1,4 in the copolymer. The prevalent polysaccharides in carrageenan are designated as kappa, iota, lambda depending on the number of sulphate by repeating unit (i.e. 1,2,3 sulphate). Between kappa and iota there is a continuum of intermediate compositions differing in number of sulphates per repeat units between 1 and 2. During the process, no organic precipitant shall be used other than methanol, ethanol and propan-2-ol. The wording carrageenan is reserved for the non hydrolysed or otherwise chemically degraded polymer. Formaldehyde may be present as an adventitious impurity up to a maximum of 5 mg/kg.
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L 83/141
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for galactose Test for anhydrogalactose Test for sulphate Solubility Purity Solvent residues Viscosity Loss on drying Sulphates Ash Acid-insoluble ash Acid-insoluble matter Low molecular weight carrageenan (Molecular weight fraction below 50 kDa) Arsenic Lead Mercury Cadmium Microbiological criteria Total plate count Yeast and moulds Escherichia coli Salmonella spp.
232-524-2 Sulphate esters of polygalactose
Yellowish to colourless, coarse to fine powder which is practically odourless
Passes test Passes test Passes test Soluble in hot water; insoluble in alcohol for a 1,5 % dilution
Not more than 0,1 % of methanol, ethanol, propan-2-ol, singly or in combination Not less than 5 mPa.s (1,5 % solution at 75 C) Not more than 12 % (105 C, 4 hours) Not less than 15 % and not more than 40 % on the dried basis (as SO4) Not less than 15 % and not more than 40 % determined on the dried basis at 550 C Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid) Not more than 2 % on the dried basis (insoluble in 1 % v/v sulphuric acid) Not more than 5 %
E 407a PROCESSED EUCHEUMA SEAWEED Synonyms PES (acronym for processed eucheuma seaweed). The PES obtained from Euchema cottonii is generally called kappa PES and the PES from Euchema spinosum iota PES.
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Definition
Processed eucheuma seaweed is obtained by aqueous alkaline (KOH) treatment at high temperature of the strains of seaweeds Eucheuma cottonii and Eucheuma spinosum, of the class Rhodophyceae (red seaweeds) followed by fresh water washing to remove impurities and drying to obtain the product. Further purification may be achieved by washing with an alcohol. The alcohols authorised are restricted to methanol, ethanol or propan-2-ol. The product consists chiefly of the potassium, sodium, magnesium and calcium sulphate esters of galactose and 3,6-anhydrogalactose polysaccharide. Up to 15 % algal cellulose is also present in the product. The wording processed eucheuma seaweed is reserved to the non hydrolysed or otherwise chemically degraded polymer. Formaldehyde may be present up to a maximum of 5 mg/kg. Tan to yellowish, coarse to fine powder which is practically odourless
Description Identification Test for galactose Test for anhydrogalactose Test for sulphate Solubility Purity Solvent residues Viscosity Loss on drying Sulphate Ash Acid-insoluble ash Acid-insoluble matter Low molecular weight carrageenan (Molecular weight fraction below 50 kDa) Arsenic Lead Mercury Cadmium Microbiological criteria Total plate count Yeast and moulds Escherichia coli Salmonella spp.
Passes test Passes test Passes test Forms cloudy viscous suspensions in water. Insoluble in ethanol for a 1,5 % solution.
Not more than 0,1 % of methanol, ethanol, propan-2-ol, singly or in combination Not less than 5 mPa.s (1,5 % solution at 75 C) Not more than 12 % (105 C, 4 hours) Not less than 15 % and not more than 40 % on the dried basis (as SO4) Not less than 15 % and not more than 40 % determined on the dried basis at 550 C Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid) Not less than 8 % and not more than 15 % on the dried basis (insoluble in 1 % v/v sulphuric acid) Not more than 5 %
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L 83/143
E 410 LOCUST BEAN GUM Synonyms Definition Carob bean gum; Algaroba gum Locust bean gum is the ground endosperm of the seeds of the strains of carob tree, Cerationia siliqua (L.) Taub. (family Leguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide, composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan 232-541-5
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for galactose Test for mannose Microscopic examination
50 000-3 000 000 Galactomannan content not less than 75 % White to yellowish-white, nearly odourless powder
Passes test Passes test Place some ground sample in an aqueous solution containing 0,5 % iodine and 1 % potassium iodide on a glass slide and examine under microscope. Locust bean gum contains long stretched tubiform cells, separated or slightly interspaced. Their brown contents are much less regularly formed than in guar gum. Guar gum shows close groups of round to pear shaped cells. Their contents are yellow to brown Soluble in hot water, insoluble in ethanol
Solubility Purity Loss on drying Ash Protein (N 6,25) Acid-insoluble matter Starch
Not more than 15 % (105 C, 5 hours) Not more than 1,2 % determined at 800 C Not more than 7 % Not more than 4 % Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. No blue colour is produced Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 %, single or in combination
Arsenic Lead Mercury Cadmium Ethanol and propan-2-ol
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E 412 GUAR GUM Synonyms Definition Gum cyamopsis; Guar flour Guar gum is the ground endosperm of the seeds of strains of the guar plant, Cyamopsis tetragonolobus (L.) Taub. (family Leguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan. The gum may be partially hydrolysed by either heat treatment, mild acid or alcaline oxidative treatment for viscosity adjust ment. 232-536-0
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for galactose Test for mannose Solubility Purity Loss on drying Ash Acid-insoluble matter Protein Starch
50 000-8 000 000 Galactomannan content not less than 75 % A white to yellowish-white, nearly odourless powder
Passes test Passes test Soluble in cold water
Not more than 15 % (105 C, 5 hours) Not more than 5,5 % determined at 800 C Not more than 7 % Not more than 10 % (factor N x 6,25) Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. (No blue colour is produced) Not more than 0,7 meq active oxygen/kg sample Not more than 1 mg/kg Not more than 0,01 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
Organic peroxides Furfural Pentachlorophenol Arsenic Lead Mercury Cadmium
E 413 TRAGACANTH Synonyms Definition Tragacanth gum; Tragant Tragacanth is a dried exudation obtained from the stems and branches of strains of Astragalus gummifer Labillardiere and other Asiatic species of Astragalus (family Leguminosae). It consists mainly of high molecular weight polysaccharides (galactoarabans and acidic polysaccharides) which, on hydrolysis, yield galacturonic acid, galactose, arabinose, xylose and fucose. Small amounts of rhamnose and of glucose (derived from traces of starch and/or cellulose) may also be present
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232-252-5
Approximately 800 000
Unground Tragacanth gum occurs as flattened, lamellated, straight or curved fragments or as spirally twisted pieces 0,5-2,5 mm thick and up to 3 cm in length. It is white to pale yellow in colour but some pieces may have a red tinge. The pieces are horny in texture, with a short fracture. It is odourless and solutions have an insipid mucilaginous taste. Powdered tragacanth is white to pale yellow or pinkish brown (pale tan) in colour
Identification Solubility 1 g of the sample in 50 ml of water swells to form a smooth, stiff, opalescent mucilage; insoluble in ethanol and does not swell in 60 % (w/v) aqueous ethanol
Purity Test for Karaya gum Negative. Boil 1 g with 20 ml of water until a mucilage is formed. Add 5 ml of hydrochloric acid and again boil the mixture for five minutes. No permanent pink or red colour develops Not more than 16 % (105 C, 5 hours) Not more than 4 % Not more than 0,5 % Not more than 2 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
Loss on drying Total ash Acid insoluble ash Acid insoluble matter Arsenic Lead Mercury Cadmium Microbiological criteria Salmonella spp. Escherichia coli
Absent in 10 g Absent in 5 g
E 414 ACACIA GUM Synonyms Definition Gum arabic Acacia gum is a dried exudation obtained from the stems and branches of strains of Acacia senegal (L) Willdenow or closely related species of Acacia (family Leguminosae). It consists mainly of high molecular weight polysaccharides and their calcium, magnesium and potassium salts, which on hydrolysis yield arabinose, galactose, rhamnose and glucuronic acid 232-519-5
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Molecular weight Assay Description
Approximately 350 000
Unground acacia gum occurs as white or yellowish-white spheroidal tears of varying sizes or as angular fragments and is sometimes mixed with darker fragments. It is also available in the form of white to yellowish-white flakes, granules, powder or spray-dried material.
Identification Solubility Purity Loss on drying Total ash Acid insoluble ash Acid insoluble matter Starch or dextrin Tannin Not more than 17 % (105 C, 5 hours) for granular and not more than 10 % (105 C, 4 hours) for spray-dried material Not more than 4 % Not more than 0,5 % Not more than 1 % Boil a 1 in 50 solution of the gum and cool. To 5 ml add 1 drop of iodine solution. No bluish or reddish colours are produced To 10 ml of a 1 in 50 solution add about 0,1 ml of ferric chloride solution (9 g FeCl3.6H2O made up to 100 ml with water). No blackish colouration or blackish precipitate is formed Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Mannose, xylose and galacturonic acid are absent (determined by chro matography) 1 g dissolves in 2 ml of cold water forming a solution which flows readily and is acid to litmus, insoluble in ethanol
Arsenic Lead Mercury Cadmium Hydrolysis products Microbiological criteria Salmonella spp. Escherichia coli
Absent in 10 g Absent in 5 g
E 415 XANTHAN GUM Synonyms Definition Xanthan gum is a high molecular weight polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with strains of Xant homonas campestris, purified by recovery with ethanol or propan-2-ol, dried and milled. It contains D-glucose and D-mannose as the dominant hexose units, along with D-glucuronic acid and pyruvic acid, and is prepared as the sodium, potassium or calcium salt. Its solutions are neutral 234-394-2
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Molecular weight Assay Description Identification Solubility Purity Loss on drying Total ash Pyruvic acid Nitrogen Ethanol and propan-2-ol Lead Microbiological criteria Total plate count Yeast and moulds Escherichia coli Salmonella spp. Xanthomonas campestris
Approximately 1 000 000 Yields, on dried basis, not less than 4,2 % and not more than 5 % of CO2 corresponding to between 91 % and 108 % of xanthan gum Cream-coloured powder
Soluble in water. Insoluble in ethanol
Not more than 15 % (105 C, 2,5 hours) Not more than 16 % on the anhydrous basis determined at 650 C after drying at 105 C for four hours Not less than 1,5 % Not more than 1,5 % Not more than 500 mg/kg singly or in combination Not more than 2 mg/kg
Not more than 5 000 colonies per gram Not more than 300 colonies per gram Absent in 5 g Absent in 10 g Viable cells absent in 1 g
E 416 KARAYA-GUM Synonyms Definition Katilo; Kadaya; Gum sterculia; Sterculia; Karaya, gum karaya; Kullo; Kuterra Karaya gum is a dried exudation from the stems and branches of strains of: Sterculia urens Roxburgh and other species of Sterculia (family Sterculiaceae) or from Cochlospermum gossypium A.P. De Candolle or other species of Cochlospermum (family Bixaceae). It consists mainly of high molecular weight acetylated polysaccharides, which on hydrolysis yield galactose, rhamnose, and galacturonic acid, together with minor amounts of glucuronic acid 232-539-4
Karaya gum occurs in tears of variable size and in broken irregular pieces having a characteristic semi-crystalline appearance. It is pale yellow to pinkish brown in colour, translucent and horny. Powdered karaya gum is a pale grey to pinkish brown. The gum has a distinctive odour of acetic acid
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Identification Solubility Swelling in ethanol solution Purity Loss on drying Total ash Acid insoluble ash Acid insoluble matter Volatile acid Starch Arsenic Lead Mercury Cadmium Microbiological criteria Salmonella spp. Escherichia coli Absent in 10 g Absent in 5 g Not more than 20 % (105 C, 5 hours) Not more than 8 % Not more than 1 % Not more than 3 % Not less than 10 % (as acetic acid) Not detectable Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Insoluble in ethanol Karaya gum swells in 60 % ethanol distinguishing it from other gums
E 417 TARA GUM Definition Tara gum is obtained by grinding the endosperm of the seeds of strains of Caesalpinia spinosa (family Leguminosae). It consists chiefly of poly saccharides of high molecular weight composed mainly of galactom annans. The principal component consists of a linear chain of (1-4)-D-mannopyranose units with -D-galactopyranose units attached by (16) linkages. The ratio of mannose to galactose in tara gum is 3:1. (In locust bean gum this ratio is 4:1 and in guar gum 2:1) 254-409-6
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Gel formation Purity Loss on drying Ash Acid insoluble matter
A white to white-yellow odourless powder
Soluble in water, insoluble in ethanol To an aqueous solution of the sample add small amounts of sodium borate. A gel is formed
Not more than 15 % Not more than 1,5 % Not more than 2 %
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Protein Starch Arsenic Lead Mercury Cadmium
Not more than 3,5 % (factor N x 5,7) Not detectable Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 418 GELLAN GUM Synonyms Definition Gellan gum is a high molecular weight polysaccharide gum produced by a pure culture fermentation of a carbohydrate by strains of Pseu domonas elodea, purified by recovery with propan-2-ol or ethanol, dried, and milled. The high molecular weight polysaccharide is principally composed of a tetrasaccharide repeating unit of one rhamnose, one glucuronic acid, and two glucoses, and substituted with acyl (glyceryl and acetyl) groups as the O-glycosidically linked esters. The glucuronic acid is neutralised to a mixed potassium, sodium, calcium, and magnesium salt 275-117-5
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility
Approximately 500 000 Yields, on the dried basis, not less than 3,3 % and not more than 6,8 % of CO2 An off-white powder
Soluble in water, forming a viscous solution. Insoluble in ethanol
Purity Loss on drying Nitrogen Propan-2-ol Arsenic Lead Mercury Cadmium Microbiological criteria Total plate count Yeast and moulds Escherichia coli Salmonella spp. Not more than 10 000 colonies per gram Not more than 400 colonies per gram Negative in 5 g Negative in 10 g Not more than 15 % after drying (105 C, 2,5 hours) Not more than 3 % Not more than 750 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
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E 420 (i) SORBITOL Synonyms Definition D-glucitol; D-sorbitol Sorbitol is obtained by hydrogenation of D-glucose. It is mainly composed of D-sorbitol. According to the level of D-glucose, the part of the products which is not D-sorbitol is composed of related substances such as mannitol, iditol, maltitol. 200-061-5 D-glucitol C6H14O6 182,2 Content not less than 97 % of total glycitols and not less than 91 % of D-sorbitol on dry weight basis (glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where n is an integer). White hygroscopic powder, crystalline powder, flakes or granules. The solution is clear.
Description Appearance of the aqueous solution: Identification Solubility Melting range Sorbitol monobenzylidene derivative
Very soluble in water, slightly soluble in ethanol 88 to 102 C To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot, cool the filtrate, filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 C
Purity Water content Sulphated ash Reducing sugars Total sugars Chlorides Sulphates Nickel Arsenic Lead Not more than 1,5 % (Karl Fischer method) Not more than 0,1 % (expressed on dry weight basis) Not more than 0,3 % (expressed as glucose on dry weight basis) Not more than 1 % (expressed as glucose on dry weight basis) Not more than 50 mg/kg (expressed on dry weight basis) Not more than 100 mg/kg (expressed on dry weight basis) Not more than 2 mg/kg (expressed on dry weight basis) Not more than 3 mg/kg (expressed on dry weight basis) Not more than 1 mg/kg (expressed on dry weight basis)
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L 83/151
E 420 (ii) SORBITOL SYRUP Synonyms Definition D-glucitol syrup Sorbitol syrup formed by hydrogenation of glucose syrup is composed of D-sorbitol, D-mannitol and hydrogenated saccharides. The part of the product which is not D-sorbitol is composed mainly of hydrogenated oligosaccharides formed by the hydrogenation of glucose syrup used as raw material (in which case the syrup is non-crystallising) or mannitol. Minor quantities of glycitols where n 4 may be present (glycitols are compounds with the structural formula CH2OH-(CHOH)nCH2OH, where n is an integer) Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Sorbitol monobenzylidene derivative Miscible with water, with glycerol, and with propane-1,2-diol To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot. Cool the filtrate filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 C Content not less than 69 % total solids and not less than 50 % of D-sorbitol on the anhydrous basis Clear and colourless aqueous solution 270-337-8
Purity Water content Sulphated ash Reducing sugars Chlorides Sulphates Nickel Arsenic Lead Not more than 31 % (Karl Fischer method) Not more than 0,1 % (on dry weight basis) Not more than 0,3 % (expressed as glucose on dry weight basis) Not more than 50 mg/kg (on dry weight basis) Not more than 100 mg/kg (on dry weight basis) Not more than 2 mg/kg (on dry weight basis) Not more than 3 mg/kg (on dry weight basis) Not more than 1 mg/kg (on dry weight basis)
E 421 MANNITOL (i) MANNITOL Synonyms Definition D-mannitol The product contains min. 96 % mannitol. The part of the product which is not mannitol is mainly composed of sorbitol (2 % max), maltitol (2 % max) and isomalt (1,1 GPM (1-O-alpha-D-Glucopy ranosyl-D-mannitol dehydrate): 2 % max and 1,6 GPS (6-O-alpha-DGlucopyranosyl-D-Sorbitol): 2 % max). Unspecified impurities shall not represent more than 0,1 % of each. Manufactured by catalytic hydrogenation of carbohydrate solutions containing glucose and/or fructose
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Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Melting range Infrared absorption spectrometry Specific rotation pH
200-711-8 D-mannitol C6H14O6 182,2 Content not less than 96,0 % D-mannitol and not more than 102 % on the dried basis White, odourless, crystalline powder
Soluble in water, very slightly soluble in ethanol, practically insoluble in ether Between 164 and 169 C Comparison with a reference standard e.g. EP or USP []D20 + 23 to + 25 (borate solution) Between 5 and 8. Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH
Purity Water content Reducing sugars Total sugars Sulphated ash Chlorides Sulphate Nickel Lead Not more than 0,5 % (Karl Fischer method) Not more than 0,3 % (as glucose) Not more than 1 % (expressed as glucose) Not more than 0,1 % Not more than 70 mg/kg Not more than 100 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
(ii) MANNITOL MANUFACTURED BY FERMENTATION Synonyms Definition D-mannitol Manufactured by discontinuous fermentation under aerobic conditions using a conventional strain of the yeast Zygosaccharomyces rouxii. The part of the product which is not mannitol is mainly composed of sorbitol, maltitol and isomalt. 200-711-8 D-mannitol C6H14O6 182,2 Not less than 99 % on the dried basis White, odourless crystalline powder
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L 83/153
Identification Solubility Melting range Infrared absorption spectrometry Specific rotation pH Soluble in water, very slightly soluble in ethanol, practically insoluble in ether Between 164 and 169 C Comparison with a reference standard e.g. EP or USP []D20 + 23 to + 25 (borate solution) Between 5 and 8 Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH Purity Arabitol Water content Reducing sugars Total sugars Sulphated ash Chlorides Sulphate Lead Microbiological criteria Aerobic mesophilic bacteria Coliforms Salmonella spp. Escherichia coli Staphylococcus aureus Pseudomonas aeruginosa Moulds Yeasts Not more than 1 000 colonies per gram Absent in 10 g Absent in 25 g Absent in 10 g Absent in 10 g Absent in 10 g Not more than 100 colonies per gram Not more than 100 colonies per gram Not more than 0,3 % Not more than 0,5 % (Karl Fischer method) Not more than 0,3 % (expressed as glucose) Not more than 1 % (as glucose) Not more than 0,1 % Not more than 70 mg/kg Not more than 100 mg/kg Not more than 1 mg/kg
E 422 GLYCEROL Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description 200-289-5 1,2,3-propanetriol; Glycerol; Trihydroxypropane C3H8O3 92,10 Content not less than 98 % of glycerol on the anhydrous basis Clear, colourless hygroscopic syrupy liquid with not more than a slight characteristic odour, which is neither harsh nor disagreeable Glycerin; Glycerine
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Identification Acrolein formation on heating Heat a few drops of the sample in a test tube with about 0,5 g of potassium bisulphate. The characteristic pungent vapours of acrolein are evolved Not less than 1,257 [n]D20 between 1,471 and 1,474
Specific gravity (25 C/25 C) Refractive index Purity Water content Sulphated ash Butanetriols Acrolein, glucose compounds and ammonium
Not more than 5 % (Karl Fischer method) Not more than 0,01 % determined at 800 25 C Not more than 0,2 % Heat a mixture of 5 ml of glycerol and 5 ml of potassium hydroxide solution (1 in 10) at 60 C for five minutes. It neither becomes yellow nor emits an odour of ammonia Not more than 0,1 % calculated as butyric acid Not more than 30 mg/kg (as chlorine) Not more than 0,1 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
Fatty acids and esters Chlorinated compounds 3-Monochloropropane-1,2-diol (3-MCPD) Arsenic Lead Mercury Cadmium
E 425 (i) KONJAC GUM Synonyms Definition Konjac gum is a water-soluble hydrocolloid obtained from the Konjac flour by aqueous extraction. Konjac flour is the unpurified raw product from the root of the perennial plant Amorphophallus konjac. The main component of Konjac gum is the water-soluble high-molecular-weight polysaccharide glucomannan, which consists of D-mannose and Dglucose units at a molar ratio of 1,6:1,0, connected by (1-4)-glycosidic bonds. Shorter side chains are attached through (1-3)-glycosidic bonds, and acetyl groups occur at random at a ratio of about 1 group per 9 to 19 sugar units
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Dispersible in hot or cold water forming a highly viscous solution with a pH between 4,0 and 7,0 The main component, glucomannan, has an average molecular weight of 200 000 to 2 000 000 Not less than 75 % carbohydrate A white to cream to light tan powder
22.3.2012
EN
L 83/155
Gel formation Formation of heat-stable gel
Add 5 ml of a 4 % sodium borate solution to a 1 % solution of the sample in a test tube, and shake vigorously. A gel forms Prepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture in a water bath to 85 C, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed
Purity Loss on drying Starch Protein Viscosity (1 % solution) Ether-soluble material Total ash Arsenic Lead Microbiological criteria Salmonella spp. Escherichia coli Absent in 12,5 g Absent in 5 g Not more than 12 % (105 C, 5 hours) Not more than 3 % Not more than 3 % (factor N 5,7) Not less than 3 kgm 1s 1 at 25 C Not more than 0,1 % Not more than 5,0 % (800 C, 3 to 4 hours) Not more than 3 mg/kg Not more than 2 mg/kg
E 425 (ii) KONJAC GLUCOMANNAN Synonyms Definition Konjac glucomannan is a water-soluble hydrocolloid obtained from Konjac flour by washing with water-containing ethanol. Konjac flour is the unpurified raw product from the tuber of the perennial plant Amorphophallus konjac. The main component is the water-soluble highmolecular-weight polysaccharide glucomannan, which consists of Dmannose and D-glucose units at a molar ratio of 1,6:1,0, connected by (1-4)-glycosidic bonds with a branch at about each 50th or 60th unit. About each 19th sugar residue is acetylated
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Dispersible in hot or cold water forming a highly viscous solution with a pH between 5,0 and 7,0. Solubility is increased by heat and mech anical agitation 500 000 to 2 000 000 Total dietary fibre: not less than 95 % on a dry weight basis White to slightly brownish fine particle size, free flowing and odourless powder
L 83/156
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22.3.2012
Formation of heat-stable gel
Prepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture in a water bath to 85 C, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed
Purity Loss on drying Starch Viscosity (1 % solution) Protein Not more than 8 % (105 C, 3 hours) Not more than 1 % Not less than 20 kgm 1s 1 at 25 C Not more than 1,5 % (N 5,7) Determine nitrogen by Kjeldahl method. The percentage of nitrogen in the sample multiplied by 5,7 gives the percent of protein in the sample Ether-soluble material Sulphite (as SO2) Chloride 50 % Alcohol-soluble material Total ash Lead Microbiological criteria Salmonella spp. Escherichia coli Absent in 12,5 g Absent in 5 g Not more than 0,5 % Not more than 4 mg/kg Not more than 0,02 % Not more than 2,0 % Not more than 2,0 % (800 C, 3 to 4 hours) Not more than 1 mg/kg
E 426 SOYBEAN HEMICELLULOSE Synonyms Definition Soybean Hemicellulose is a refined water-soluble polysaccharide obtained from strain soybean fibre by hot water extraction. No organic precipitant shall be used other than ethanol
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility pH Purity Loss on drying Not more than 7 % (105 C, 4 hours) Soluble in hot and cold water without gel formation 5,5 1,5 (1% solution) Not less than 74 % carbohydrate Free flowing white or yellowish white powder Water soluble soybean polysaccharides; Water soluble soybean fibre
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L 83/157
Protein Viscosity Total ash Arsenic Ethanol Lead Mercury Cadmium Microbiological criteria Total plate count Yeast and moulds Escherichia coli
Not more than 14 % Not more than 200 mPa.s (10 % solution) Not more than 9,5 % (600 C, 4 hours) Not more than 2 mg/kg Not more than 2% Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
Not more than 3 000 colonies per gram Not more than 100 colonies per gram Absent in 10 g
E 427 CASSIA GUM Synonyms Definition Cassia gum is the ground purified endosperm of the seeds of Cassia tora and Cassia obtusifoli (Leguminosae) containing less than 0,05 % of Cassia occidentalis. It consists mainly of high molecular weight polysaccharides composed primarily of a linear chain of 1,4--D-mannopyranose units linked with 1,6--D-galactopyranose units. The ratio of mannose to galactose is about 5:1. In the manufacture the seeds are dehusked and degermed by thermal mechanical treatment followed by milling and screening of the endosperm. The ground endosperm is further purified by extraction with propan-2-ol. Assay Description Identification Solubility Insoluble in ethanol. Disperses well in cold water forming a colloidal solution. To an aqueous dispersion of the sample add sufficient sodium borate test solution (TS) to raise the pH to above 9; a gel is formed. Weigh 1,5 g of the sample and 1,5 g of xanthan gum and blend them. Add this blend (with rapid stirring) into 300 ml water at 80 C in a 400 ml beaker. Stir until the mixture is dissolved and continue stirring for an extra 30 min after dissolution (maintain the temperature above 60 C during the stirring process). Discontinue stirring and allow the mixture to cool at room temperature for at least 2 h. A firm, viscoelastic gel forms after the temperature drops below 40 C, but no such gel forms in a 1 % control solution of cassia gum or xanthan gum alone prepared in a similar manner. Viscosity Less than 500 mPa.s (25 C, 2h, 1 % solution) corresponding to an average molecular weight of 200 000-300 000 Da Not less than 75 % of Galactomannan Pale yellow to off-white, odourless powder
Gel formation with borate
Gel formation with xanthan gum
L 83/158
EN
22.3.2012
Purity Acid insoluble matter pH Crude fat Protein Total ash Loss on drying Total anthraquinones Solvent residues Lead Microbiological criteria Total plate count Yeast and moulds Salmonella spp. Escherichia coli Not more than 5 000 colony forming units per gram Not more than 100 colony forming units per gram Absent in 25 g Absent in 1 g Not more than 2,0 % 5,5-8 (1 % aqueous solution) Not more than 1 % Not more than 7 % Not more than 1,2 % Not more than 12 % (5h, 105 C) Not more than 0,5 mg/kg(detection limit) Not more than 750 mg/kg Propan-2-ol Not more than 1 mg/kg
E 431 POLYOXYETHYLENE (40) STEARATE Synonyms Definition Polyoxyl (40) stearate; Polyoxyethylene (40) monostearate A mixture of the mono- and diesters of edible commercial stearic acid and mixed polyoxyethylene diols (having an average polymer length of about 40 oxyethylene units) together with free polyol
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Congealing range Infrared absorption spectrum Purity Water content Acid value Saponification value Hydroxyl value Not more than 3 % (Karl Fischer method) Not more than 1 Not less than 25 and not more than 35 Not less than 27 and not more than 40 Soluble in water, ethanol, methanol and ethyl acetate. Insoluble in mineral oil 39-44 C Characteristic of a partial fatty acid ester of a polyoxyethylated polyol Content not less than 97,5 % on the anhydrous basis Cream-coloured flakes or waxy solid at 25 C with a faint odour
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L 83/159
1,4-Dioxane Ethylene oxide Ethylene glycols (mono- and di-) Arsenic Lead Mercury Cadmium
Not more than 5 mg/kg Not more than 0,2 mg/kg Not more than 0,25 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 432 POLYOXYETHYLENE SORBITAN MONOLAURATE (POLYSORBATE 20) Synonyms Definition Polysorbate 20; Polyoxyethylene (20) sorbitan monolaurate A mixture of the partial esters of sorbitol and its mono- and dianhy drides with edible commercial lauric acid and condensed with approxi mately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Einecs Chemical name Chemical formula Molecular weight Assay Content not less than 70 % of oxyethylene groups, equivalent to not less than 97,3 % of polyoxyethylene (20) sorbitan monolaurate on the anhydrous basis A lemon to amber-coloured oily liquid at 25 C with a faint char acteristic odour
Description Identification Solubility Infrared absorption spectrum Purity Water content Acid value Saponification value Hydroxyl value 1,4-dioxane Ethylene oxide Ethylene glycols (mono- and di-) Arsenic Lead Mercury Cadmium
Soluble in water, ethanol, methanol, ethyl acetate and dioxane. Insoluble in mineral oil and petroleum ether Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Not more than 3 % (Karl Fischer method) Not more than 2 Not less than 40 and not more than 50 Not less than 96 and not more than 108 Not more than 5 mg/kg Not more than 0,2 mg/kg Not more than 0,25 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
L 83/160
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22.3.2012
E 433 POLYOXYETHYLENE SORBITAN MONOOLEATE (POLYSORBATE 80) Synonyms Definition Polysorbate 80; Polyoxyethylene (20) sorbitan monooleate A mixture of the partial esters of sorbitol and its mono- and dianhy drides with edible commercial oleic acid and condensed with approxi mately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Einecs Chemical name Chemical formula Molecular weight Assay Content not less than 65 % of oxyethylene groups, equivalent to not less than 96,5 % of polyoxyethylene (20) sorbitan monooleate on the anhydrous basis A lemon to amber-coloured oily liquid at 25 C with a faint char acteristic odour
Description
Identification Solubility Soluble in water, ethanol, methanol, ethyl acetate and toluene. Insoluble in mineral oil and petroleum ether Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Infrared absorption spectrum Purity Water content Acid value Saponification value Hydroxyl value 1,4-dioxane Ethylene oxide Ethylene glycols (mono- and di-) Arsenic Lead Mercury Cadmium
E 434 POLYOXYETHYLENE SORBITAN MONOPALMITATE (POLYSORBATE 40) Synonyms Definition Polysorbate 40; Polyoxyethylene (20) sorbitan monopalmitate A mixture of the partial esters of sorbitol and its mono- and dianhy drides with edible commercial palmitic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
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L 83/161
Einecs Chemical name Chemical formula Molecular weight Assay Content not less than 66 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monopalmitate on the anhydrous basis A lemon to orange-coloured oily liquid or semi-gel at 25 C with a faint characteristic odour
Soluble in water, ethanol, methanol, ethyl acetate and acetone. Insoluble in mineral oil Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
E 435 POLYOXYETHYLENE SORBITAN MONOSTEARATE (POLYSORBATE 60) Synonyms Definition Polysorbate 60; Polyoxyethylene (20) sorbitan monostearate A mixture of the partial esters of sorbitol and its mono- and dianhy drides with edible commercial stearic acid and condensed with approxi mately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Einecs Chemical name Chemical formula Molecular weight Assay Content not less than 65 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monostearate on the anhydrous basis
L 83/162
EN
22.3.2012
A lemon to orange-coloured oily liquid or semi-gel at 25 C with a faint characteristic odour
Soluble in water, ethyl acetate and toluene. Insoluble in mineral oil and vegetable oils Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
E 436 POLYOXYETHYLENE SORBITAN TRISTEARATE (POLYSORBATE 65) Synonyms Definition Polysorbate 65; Polyoxyethylene (20) sorbitan tristearate A mixture of the partial esters of sorbitol and its mono- and dianhy drides with edible commercial stearic acid and condensed with approxi mately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Einecs Chemical name Chemical formula Molecular weight Assay Content not less than 46 % of oxyethylene groups, equivalent to not less than 96 % of polyoxyethylene (20) sorbitan tristearate on the anhydrous basis A tan-coloured, waxy solid at 25 C with a faint characteristic odour
Description Identification Solubility Congealing range Infrared absorption spectrum
Dispersible in water. Soluble in mineral oil, vegetal oils, petroleum ether, acetone, ether, dioxane, ethanol and methanol 29-33 C Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
22.3.2012
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L 83/163
Purity Water content Acid value Saponification value Hydroxyl value 1,4-dioxane Ethylene oxide Ethylene glycols (mono- and di-) Arsenic Lead Mercury Cadmium Not more than 3 % (Karl Fischer method) Not more than 2 Not less than 88 and not more than 98 Not less than 40 and not more than 60 Not more than 5 mg/kg Not more than 0,2 mg/kg Not more than 0,25 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 440 (i) PECTIN Synonyms Definition Pectin consists mainly of the partial methyl esters of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of strains of appropriate edible plant material, usually citrus fruits or apples. No organic precipitant shall be used other than methanol, ethanol and propan-2-ol 232-553-0
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Purity Loss on drying Acid insoluble ash Sulphur dioxide Nitrogen content Total insolubles Solvent residues
Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol White, light yellow, light grey or light brown powder
Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol
Not more than 12 % (105 C, 2 hours) Not more than 1 % (insoluble in approximately 3N hydrochloric acid) Not more than 50 mg/kg on the anhydrous basis Not more than 1,0 % after washing with acid and ethanol Not more than 3 % Not more than 1 % of free methanol, ethanol and propan-2-ol, singly or in combination, on the volatile matter-free basis
L 83/164
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22.3.2012
E 440 (ii) AMIDATED PECTIN Synonyms Definition Amidated pectin consists mainly of the partial methyl esters and amides of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of appropriate strains of edible plant material, usually citrus fruits or apples and treatment with ammonia under alkaline conditions. No organic precipitant shall be used other than methanol, ethanol and propan-2-ol
Einecs Chemical name Chemical formula Molecular weight Assay Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol White, light yellow, light greyish or light brownish powder
Description Identification Solubility
Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol
Purity Loss on drying Acid-insoluble ash Degree of amidation Sulphur dioxide residue Nitrogen content Total insolubles: Solvent residues Not more than 12 % (105 C, 2 hours) Not more than 1 % (insoluble in approximately 3N hydrochloric acid) Not more than 25 % of total carboxyl groups Not more than 50 mg/kg on the anhydrous basis Not more than 2,5 % after washing with acid and ethanol Not more than 3 % Not more than 1 % of methanol, ethanol and propan-2-ol, singly or in combination, on a volatile matter-free basis Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
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L 83/165
E 442 AMMONIUM PHOSPHATIDES Synonyms Definition Ammonium salts of phosphatidic acid; Mixed ammonium salts of phoshorylated glycerides A mixture of the ammonium compounds of phosphatidic acids derived from edible fat and oil. One or two or three glyceride moieties may be attached to phosphorus. Moreover, two phosphorus esters may be linked together as phosphatidyl phosphatides
Einecs Chemical name Chemical formula Molecular weight Assay The phosphorus content is not less than 3 % and not more than 3,4 % by weight; the ammonium content is not less than 1,2 % and not more than 1,5 % (calculated as N) Unctuous semi-solid to oily solid
Description Identification Solubility Test for glycerol Test fatty acids Test for phosphate Purity Petroleum ether insoluble matter Arsenic Lead Mercury Cadmium
Soluble in fats. Insoluble in water. Partially soluble in ethanol and in acetone Passes test Passes test Passes test
E 444 SUCROSE ACETATE ISOBUTYRATE Synonyms Definition SAIB Sucrose acetate isobutyrate is a mixture of the reaction products formed by the esterification of food grade sucrose with acetic acid anhydride and isobutyric anhydride, followed by distillation. The mixture contains all possible combinations of esters in which the molar ratio of acetate to butyrate is about 2:6 204-771-6 Sucrose diacetate hexaisobutyrate C40H62O19 832-856 (approximate), C40H62O19: 846,9 Content not less than 98,8 % and not more than 101,9 % of C40H62O19 A pale straw-coloured liquid, clear and free of sediment and having a bland odour
L 83/166
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22.3.2012
Identification Solubility Refractive index Specific gravity Purity Triacetin Acid value Saponification value Arsenic Lead Mercury Cadmium Not more than 0,1 % Not more than 0,2 Not less than 524 and not more than 540 Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Insoluble in water. Soluble in most organic solvents [n]D40: 1,4492-1,4504 [d]25D: 1,141-1,151
E 445 GLYCEROL ESTERS OF WOOD ROSIN Synonyms Definition Ester gum A complex mixture of tri- and diglycerol esters of resin acids from wood rosin. The rosin is obtained by the solvent extraction of aged pine stumps followed by a liquid-liquid solvent refining process. Excluded from these specifications are substances derived from gum rosin, and exudate of living pine trees, and substances derived from tall oil rosin, a by-product of kraft (paper) pulp processing. The final product is composed of approximately 90 % resin acids and 10 % neutrals (non-acidic compounds). The resin acid fraction is a complex mixture of isomeric diterpenoid monocarboxylic acids having the empirical molecular formula of C20H30O2, chiefly abietic acid. The substance is purified by steam stripping or by countercurrent steam distillation
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Infrared absorption spectrum Purity Specific gravity of solution Ring and ball softening range Acid value Hydroxyl value Arsenic [d]2025 not less than 0,935 when determined in a 50 % solution in d-limonene (97 %, boiling point 175,5-176 C, d204: 0,84) Between 82 C and 90 C Not less than 3 and not more than 9 Not less than 15 and not more than 45 Not more than 3 mg/kg Insoluble in water, soluble in acetone Characteristic of the compound Hard, yellow to pale amber-coloured solid
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L 83/167
Lead Mercury Cadmium Test for absence of tall oil rosin (sulphur test)
Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg When sulphur-containing organic compounds are heated in the presence of sodium formate, the sulphur is converted to hydrogen sulphide which can readily be detected by the use of lead acetate paper. A positive test indicates the use of tall oil rosin instead of wood rosin
E 450 (i) DISODIUM DIPHOSPHATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 231-835-0 Disodium dihydrogen diphosphate Na2H2P2O7 221,94 Content not less than 95 % of disodium diphosphate P2O5 content not less than 63,0 % and not more than 64,5 % Description Identification Test for sodium Test for phosphate Solubility pH Purity Loss on drying Water insoluble matter Fluoride Arsenic Cadmium Lead Mercury Aluminium Not more than 0,5 % (105 C, 4 hours) Not more than 1 % Not more than 10 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 200 mg/kg Passes test Passes test Soluble in water Between 3,7 and 5,0 (1 % solution) White powder or grains Disodium dihydrogen diphosphate; Disodium dihydrogen pyrophos phate; Sodium acid pyrophosphate; Disodium pyrophosphate
E 450 (ii) TRISODIUM DIPHOSPHATE Synonyms Definition Einecs 238-735-6 Trisodium pyrophosphate; Trisodium monohydrogen diphosphate; Trisodium monohydrogen pyrophosphate; Trisodium diphosphate
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Chemical name Chemical formula Monohydrate: Na3HP2O7 H2O Anhydrous: Na3HP2O7 Molecular weight Monohydrate: 261,95 Anhydrous: 243,93 Assay Content not less than 95 % on the dried basis P2O5 content not less than 57 % and not more than 59 % Description Identification Test for sodium Test for phosphate Solubility pH Purity Loss on ignition Not more than 4,5 % on the anhydrous compound (450-550 C). Not more than 11,5 % on the monohydrate basis Loss on drying Not more than 0,5 % (105 C, 4 hours) for anhydrous Not more than 1,0 % (105 C, 4 hours) for monohdyrate Water insoluble matter Fluoride Arsenic Cadmium Lead Mercury Not more than 0,2 % Not more than 10 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Passes test Passes test Soluble in water Between 6,7 and 7,5 (1 % solution) White powder or grains, occurs anhydrous or as a monohydrate
E 450 (iii) TETRASODIUM DIPHOSPHATE Synonyms Definition Einecs Chemical name Chemical formula 231-767-1 Tetrasodium diphosphate Anhydrous: Na4P2O7 Decahydrate: Na4P2O7 10H2O Molecular weight Anhydrous: 265,94 Decahydrate: 446,09 Assay Content not less than 95 % of Na4P2O7 on the ignited basis P2O5 content not less than 52,5 % and not more than 54,0 % Description Colourless or white crystals, or a white crystalline or granular powder. The decahydrate effloresces slightly in dry air Tetrasodium pyrophosphate; Tetrasodium disphosphate; Tetrasodium phosphate
22.3.2012
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L 83/169
Identification Test for sodium Test for phosphate Solubility pH Purity Loss on ignition Not more than 0,5 % for the anhydrous salt, not less than 38 % and not more than 42 % for the decahydrate (105 C, 4 hours then 550 C, 30 minutes) Not more than 0,2 % Not more than 10 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1mg/kg Not more than 1 mg/kg Passes test Passes test Soluble in water. Insoluble in ethanol Between 9,8 and 10,8 (1 % solution)
E 450 (v) TETRAPOTASSIUM DIPHOSPHATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 230-785-7 Tetrapotassium diphosphate K4P2O7 330,34 (anhydrous) Content not less than 95 % (800 C for 0,5 hours) P2O5 content not less than 42,0 % and not more than 43,7 % on the anhydrous basis Description Identification Test for potassium Test for phosphate Solubility pH Purity Loss on ignition Water insoluble matter Fluoride Arsenic Cadmium Lead Mercury Not more than 2 % (105 C, 4 hours then 550 C, 30 minutes) Not more than 0,2 % Not more than 10 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Passes test Passes test Soluble in water, insoluble in ethanol Between 10,0 and 10,8 (1 % solution) Colourless crystals or white, very hygroscopic powder Tetrapotassium pyrophosphate
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E 450 (vi) DICALCIUM DIPHOSPHATE Synonyms Definition Einecs Chemical name 232-221-5 Dicalcium diphosphate Dicalcium pyrophosphate Chemical formula Molecular weight Assay Ca2P2O7 254,12 Content not less than 96 % P2O5 content not less than 55 % and not more than 56 % Description Identification Test for calcium Test for phosphate Solubility pH Purity Loss on ignition Fluoride Arsenic Cadmium Lead Mercury Not more than 1,5 % (800 C 25 C, 30 minutes Not more than 50 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Passes test Passes test Insoluble in water. Soluble in dilute hydrochloric and nitric acids Between 5,5 and 7,0 (10 % suspension in water) A fine, white, odourless powder Calcium pyrophosphate
E 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 238-933-2 Calcium dihydrogen diphosphate CaH2P2O7 215,97 Content not less than 90 % on the anhydrous basis P2O5 content not less than 61 % and not more than 66 % Description Identification Test for calcium Test for phosphate Passes test Passes test White crystals or powder Acid calcium pyrophosphate; Monocalcium dihydrogen pyrophosphate
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L 83/171
Purity Acid-insoluble matter Fluoride Arsenic Cadmium Lead Mercury Aluminium Not more than 0,4 % Not more than 30 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 800 mg/kg. This applies until 31 March 2015. Not more than 200 mg/kg. This applies from 1 April 2015.
E 451 (i) PENTASODIUM TRIPHOSPHATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 231-838-7 Pentasodium triphosphate Na5O10P3 nH2O (n = 0 or 6) 367,86 Content not less than 85,0 % (anhydrous) or 65,0 % (hexahydrate) P2O5 content not less than 56 % and not more than 59 % (anhydrous) or not less than 43 % and not more than 45 % (hexahydrate) Description Identification Solubility Test for sodium Test for phosphate pH Purity Loss on drying Anhydrous: Not more than 0,7 % (105 C, 1 hour) Hexahydrate: Not more than 23,5 % (60 C, 1 hour, then 105 C, 4 hours) Water insoluble matter Higher polyphosphates Fluoride Arsenic Cadmium Lead Mercury Not more than 0,1 % Not more than 1 % Not more than 10 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Freely soluble in water. Insoluble in ethanol Passes test Passes test Between 9,1 and 10,2 (1 % solution) White, slightly hygroscopic granules or powder Pentasodium tripolyphosphate; Sodium tripolyphosphate
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E 451 (ii) PENTAPOTASSIUM TRIPHOSPHATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 237-574-9 Pentapotassium triphosphate; Pentapotassium tripolyphosphate K5O10P3 448,42 Content not less than 85 % on the anhydrous basis P2O5 content not less than 46,5 % and not more than 48 % Description Identification Solubility Test for potassium Test for phosphate pH Purity Loss on ignition Water insoluble matter Fluoride Arsenic Cadmium Lead Mercury Not more than 0,4 % (105 C, 4 hours, then 550 C, 30 minutes) Not more than 2 % Not more than 10 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Very soluble in water Passes test Passes test Between 9,2 and 10,5 (1 % solution) White, very hygroscopic powder or granules Pentapotassium tripolyphosphate; Potassium triphosphate; Potassium tripolyphosphate
E 452 (i) SODIUM POLYPHOSPHATE I. SOLUBLE POLYPHOSPHATE Synonyms Sodium hexametaphosphate; Sodium tetrapolyphosphate; Graham's salt; Sodium polyphosphates, glassy; Sodium polymetaphosphate; Sodium metaphosphate Soluble sodium polyphosphates are obtained by fusion and subsequent chilling of sodium orthophosphates. These compounds are a class consisting of several amorphous, water-soluble polyphosphates composed of linear chains of metaphosphate units, (NaPO3)x where x 2, terminated by Na2PO4 groups. These substances are usually identified by their Na2O/P2O5 ratio or their P2O5 content. The Na2O/P2O5 ratios vary from about 1,3 for sodium tetrapolyphosphate, where x = approximately 4; to about 1,1 for Graham's salt, commonly called sodium hexametaphosphate, where x = 13 to 18; and to about 1,0 for the higher molecular weight sodium polyphosphates, where x = 20 to 100 or more. The pH of their solutions varies from 3,0 to 9,0 272-808-3 Sodium polyphosphate
Definition
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EN
L 83/173
Chemical formula
Heterogenous mixtures of sodium salts of linear condensed polyphos phoric acids of general formula H(n + 2)PnO(3n + 1) where n is not less than 2 (102)n P2O5 content not less than 60 % and not more than 71 % on the ignited basis Colourless or white, transparent platelets, granules, or powders
Molecular weight Assay Description Identification Solubility Test for sodium Test for phosphate pH Purity Loss on ignition Water insoluble matter Fluoride Arsenic Cadmium Lead Mercury
Very soluble in water Passes test Passes test Between 3,0 and 9,0 (1 % solution)
Not more than 1 % Not more than 0,1 % Not more than 10 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
II. INSOLUBLE POLYPHOSPHATE Synonyms Definition Insoluble sodium metaphosphate; Maddrell's salt; Insoluble sodium polyphosphate; IMP Insoluble sodium metaphosphate is a high molecular weight sodium polyphosphate composed of two long metaphosphate chains (NaPO3)x that spiral in opposite directions about a common axis. The Na2O/P2O5 ratio is about 1,0. The pH of 1 in 3 suspension in water is about 6,5 272-808-3 Sodium polyphosphate Heterogenous mixtures of sodium salts of linear condensed polyphos phoric acids of general formula H(n + 2)PnO(3n + 1) where n is not less than 2 (102)n P2O5 content not less than 68,7 % and not more than 70,0 % White crystalline powder
Molecular weight Assay Description Identification Solubility Test for sodium Test for phosphate pH
Insoluble in water, soluble in mineral acids and in solutions of potassium and ammonium (but not sodium) chlorides Passes test Passes test About 6,5 (1 in 3 suspension in water)
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Purity Fluoride Arsenic Cadmium Lead Mercury Not more than 10 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 452 (ii) POTASSIUM POLYPHOSPHATE Synonyms Definition Einecs Chemical name Chemical formula 232-212-6 Potassium polyphosphate (KPO3)n Heterogenous mixtures of potassium salts of linear condensed poly phosphoric acids of general formula H(n + 2)PnO(3n + 1) where n is not less than 2 Molecular weight Assay Description Identification Solubility Test for potassium Test for phosphate pH Purity Loss on ignition Cyclic phosphate Fluoride Arsenic Cadmium Lead Mercury Not more than 2 % (105 C, 4 hours then 550 C, 30 minutes) Not more than 8 % on P2O5 content Not more than 10 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg 1 g dissolves in 100 ml of a 1 in 25 solution of sodium acetate Passes test Passes test Not more than 7,8 (1 % suspension) (118)n P2O5 content not less than 53,5 % and not more than 61,5 % on the ignited basis Fine white powder or crystals or colourless glassy platelets Potassium metaphosphate; Potassium polymetaphosphate; Kurrol salt
E 452(iii) SODIUM CALCIUM POLYPHOSPHATE Synonyms Definition Einecs Chemical name 233-782-9 Sodium calcium polyphosphate Sodium calcium polyphosphate, glassy
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Chemical formula Molecular weight Assay Description Identification pH CaO content Purity Fluoride Arsenic Lead Cadmium Mercury
(NaPO3)n CaO where n is typically 5
P2O5 content not less than 61 % and not more than 69 % on the ignited basis White glassy crystals, spheres
Approximately 5 to 7 (1 % m/m slurry) 7 % - 15 % m/m
E 452 (iv) CALCIUM POLYPHOSPHATE Synonyms Definition Einecs Chemical name Chemical formula 236-769-6 Calcium polyphosphate (CaP2O6)n Heterogenous mixtures of calcium salts of condensed polyphosphoric acids of general formula H(n + 2)PnO(n + 1) where n is not less than 2 Molecular weight Assay Description Identification Solubility Test for calcium Test for phosphate CaO content Purity Loss on ignition Cyclic phosphate Fluoride Arsenic Cadmium Lead Mercury Not more than 2 % (105 C, 4 hours then 550 C, 30 minutes) Not more than 8 % (on P2O5 content) Not more than 30 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Usually sparingly soluble in water. Soluble in acid medium Passes test Passes test 27 to 29,5 % (198)n P2O5 content not less than 71 % and not more than 73 % on the ignited basis Odourless, colourless crystals or white powder Calcium metaphosphate; Calcium polymetaphosphate
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E 459 BETA-CYCLODEXTRIN Synonyms Definition Beta-cyclodextrin is a non-reducing cyclic saccharide consisting of seven -1,4-linked D-glucopyranosyl units. The product is manu factured by the action of the enzyme cycloglycosyltransferase (CGTase) obtained from Bacillus circulans, Paenibacillus macerans or recombinant Bacillus licheniformis strain SJ1608 on partially hydrolysed starch 231-493-2 Cycloheptaamylose (C6H10O5)7 1 135 Content not less than 98,0 % of (C6H10O5)7 on an anhydrous basis Virtually odourless white or almost white crystalline solid Clear and colourless
Einecs Chemical name Chemical formula Molecular weight Assay Description Appearance of the aqueous solution Identification Solubility Specific rotation pH value: Purity Water content Other cyclodextrins Solvent residues Sulphated ash Arsenic Lead
Sparingly soluble in water; freely soluble in hot water; slightly soluble in ethanol []D25 + 160 to + 164 (1 % solution) 5,0-8,0 (1 % solution)
Not more than 14 % (Karl Fischer method) Not more than 2 % on an anhydrous basis Not more than 1 mg/kg of each of toluene and trichloroethylene Not more than 0,1 % Not more than 1 mg/kg Not more than 1 mg/kg
E 460 (i) MICROCRYSTALLINE CELLULOSE Synonyms Definition Cellulose gel Microcrystalline cellulose is purified, partially depolymerised cellulose prepared by treating alpha-cellulose, obtained as a pulp from strains of fibrous plant material, with mineral acids. The degree of polymerisation is typically less than 400 232-674-9 Cellulose (C6H10O5)n About 36 000 Not less than 97 % calculated as cellulose on the anhydrous basis Not less than 5 m (not more than 10 % of particles of less than 5 m) A fine white or almost white odourless powder
Einecs Chemical name Chemical formula Molecular weight Assay Particle size Description
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Identification Solubility Colour reaction Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution To 1 mg of the sample, add 1 ml of phosphoric acid and heat on a water bath for 30 minutes. Add 4 ml of a 1 in 4 solution of pyro catechol in phosphoric acid and heat for 30 minutes. A red colour is produced To be identified Mix 30 g of the sample with 270 ml of water in a high-speed (12 000 rpm) power blender for 5 minutes. The resultant mixture will be either a free-following suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a 100-ml graduated cylinder and allow to stand for 1 hour. The solids settles and a supernatant liquid appears The pH of the supernatant liquid is between 5,0 and 7,5 (10 % suspension in water)
Infrared absorption spectroscopy Suspension test
pH Purity Loss on drying Water soluble matter Sulphated ash Starch
Not more than 7 % (105 C, 3 hours) Not more than 0,24 % Not more than 0,5 % (800 25 C) Not detectable To 20 ml of the dispersion obtained in Identification, suspension test, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced
Carboxyl groups Arsenic Lead Mercury Cadmium
Not more than 1 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 460 (ii) POWDERED CELLULOSE Definition Purified, mechanically disintegrated cellulose prepared by processing alpha-cellulose obtained as a pulp from strains of fibrous plant materials 232-674-9 Cellulose; Linear polymer of 1:4 linked glucose residues (C6H10O5)n (162)n (n is predominantly 1 000 and greater) Content not less than 92 % Not less than 5 m (not more than 10 % of particles of less than 5 m) A white, odourless powder
Einecs Chemical name Chemical formula Molecular weight Assay Particle size Description Identification Solubility
Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution
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Suspension test
Mix 30 g of the sample with 270 ml of water in a high-speed (12 000 rpm) power blender for 5 minutes. The resultant mixture will be either a free-flowing suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a 100-ml graduated cylinder and allow to stand for 1 hour. The solids settles and a supernatant liquid appears The pH of the supernatant liquid is between 5,0 and 7,5 (10 % suspension in water)
pH
Purity Loss on drying Water soluble matter Sulphated ash Starch Not more than 7 % (105 C, 3 hours) Not more than 1,0 % Not more than 0,3 % (800 25 C) Not detectable To 20 ml of the dispersion obtained in Identification, suspension test, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 461 METHYL CELLULOSE Synonyms Definition Cellulose methyl ether Methyl cellulose is cellulose obtained directly from strains of fibrous plant material and partially etherified with methyl groups
Einecs Chemical name Chemical formula Methyl ether of cellulose The polymers contain substituted anhydroglucose units with the following general formula: C6H7O2(OR1)(OR2)(OR3) where R1, R2, R3 each may be one of the following: H CH3 or CH2CH3 Molecular weight Assay From about 20 000 to 380 000 Content not less than 25 % and not more than 33 % of methoxyl groups (-OCH3) and not more than 5 % of hydroxyethoxyl groups (-OCH2CH2OH) Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Description
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Identification Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Insoluble in ethanol, ether and chloroform. Soluble in glacial acetic acid pH Purity Loss on drying Sulphated ash Arsenic Lead Mercury Cadmium Not more than 10 % (105 C, 3 hours) Not more than 1,5 % (800 25 C) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not less than 5,0 and not more than 8,0 (1 % colloidal solution)
E 462 ETHYL CELLULOSE Synonyms Definition Cellulose ethyl ether Ethyl cellulose is cellulose obtained directly from fibrous plant material and partially etherified with ethyl groups
Einecs Chemical name Chemical formula Ethyl ether of cellulose The polymers contain substituted anhydroglucose units with the following general formula: C6H7O2(OR1)(OR2) where R1 and R2 may be any of the following: H CH2CH3 Molecular weight Assay Content not less than 44 % and not more than 50 % of ethoxyl groups (-OC2H5) on the dried basis (equivalent to not more than 2,6 ethoxyl groups per anhydroglucose unit) Slightly hygroscopic white to off-white, odourless and tasteless powder
Description Identification Solubility
Practically insoluble in water, in glycerol and in propane-1,2-diol but soluble in varying proportions in certain organic solvents depending upon the ethoxyl content. Ethyl cellulose containing less than 46 to 48 % of ethoxyl groups is freely soluble in tetrahydrofuran, in methyl acetate, in chloroform and in aromatic hydrocarbon ethanol mixtures. Ethyl cellulose containing 46 to 48 % or more of ethoxyl groups is freely soluble in ethanol, in methanol, in toluene, in chloroform and in ethyl acetate
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Film forming test
Dissolve 5 g of the sample in 95 g of an 80:20 (w/w) mixture of toluene ethanol. A clear, stable, slightly yellow solution is formed. Pour a few ml of the solution onto a glass plate and allow the solvent to evaporate. A thick, tough, continuous, clear film remains. The film is flammable Neutral to litmus (1 % colloidal solution)
pH Purity Loss on drying Sulphated ash Arsenic Lead Mercury Cadmium
Not more than 3 % (105 C, 2 hours) Not more than 0,4 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 463 HYDROXYPROPYL CELLULOSE Synonyms Definition Cellulose hydroxypropyl ether Hydroxypropylcellulose is cellulose obtained directly from strains of fibrous plant material and partially etherified with hydroxypropyl groups
Einecs Chemical name Chemical formula Hydroxypropyl ether of cellulose The polymers contain substituted anhydroglucose units with the following general formula: C6H7O2(OR1)(OR2)(OR3), where R1, R2, R3 each may be one of the following: H CH2CHOHCH3 CH2CHO(CH2CHOHCH3)CH3 CH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3 Molecular weight Assay From about 30 000 to 1 000 000 Content not more than 80,5 % of hydroxypropoxyl groups (-OCH2CHOHCH3) equivalent to not more than 4,6 hydroxypropyl groups per anhydroglucose unit on the anhydrous basis Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Description
Identification Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether Determine the substituents by gas chromotography Not less than 5,0 and not more than 8,0 (1 % colloidal solution)
Gas chromatography pH
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Purity Loss on drying Sulphated ash Propylene chlorohydrins Arsenic Lead Mercury Cadmium Not more than 10 % (105 C, 3 hours) Not more than 0,5 % determined at 800 25 C Not more than 0,1 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 464 HYDROXYPROPYL METHYL CELLULOSE Synonyms Definition Hydroxypropyl methyl cellulose is cellulose obtained directly from strains of fibrous plant material and partially etherified with methyl groups and containing a small degree of hydroxypropyl substitution
Einecs Chemical name Chemical formula 2-Hydroxypropyl ether of methylcellulose The polymers contain substituted anhydroglucose units with the following general formula: C6H7O2(OR1)(OR2)(OR3), where R1, R2, R3 each may be one of the following: H CH3 CH2CHOHCH3 CH2CHO (CH2CHOHCH3) CH3 CH2CHO[CH2CHO (CH2CHOHCH3) CH3]CH3 Molecular weight Assay From about 13 000 to 200 000 Content not less than 19 % and not more than 30 % methoxyl groups (-OCH3) and not less than 3 % and not more than 12 % hydroxy propoxyl groups (-OCH2CHOHCH3), on the anhydrous basis Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Description
Identification Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Insoluble in ethanol Determine the substituents by gas chromatography Not less than 5,0 and not more than 8,0 (1 % colloidal solution)
Gas chromatography pH Purity Loss on drying
Not more than 10 % (105 C, 3 hours)
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Sulphated ash
Not more than 1,5 % for products with viscosities of 50 mPa.s or above Not more than 3 % for products with viscosities below 50 mPa.s
Propylene chlorohydrins Arsenic Lead Mercury Cadmium
Not more than 0,1 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 465 ETHYL METHYL CELLULOSE Synonyms Definition Methylethylcellulose Ethyl methyl cellulose is cellulose obtained directly from strains of fibrous plant material and partially etherified with methyl and ethyl groups
Einecs Chemical name Chemical formula Ethyl methyl ether of cellulose The polymers contain substituted anhydroglucose units with the following general formula: C6H7O2(OR1)(OR2)(OR3), where R1, R2, R3 each may be one of the following: H CH3 CH2CH3 Molecular weight Assay From about 30 000 to 40 000 Content on the anhydrous basis not less than 3,5 % and not more than 6,5 % of methoxyl groups (-OCH3) and not less than 14,5 % and not more than 19 % of ethoxyl groups (-OCH2CH3), and not less than 13,2 % and not more than 19,6 % of total alkoxyl groups, calculated as methoxyl Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Description
Identification Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether Not less than 5,0 and not more than 8,0 (1 % colloidal solution)
pH Purity Loss on drying
Not more than 15 % for the fibrous form, and not more than 10 % for the powdered form (105 C to constant weight)
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Sulphated ash Arsenic Lead Mercury Cadmium
E 466 SODIUM CARBOXY METHYL CELLULOSE, CARBOXY METHYL CELLULOSE, CELLULOSE GUM Synonyms Definition CMC; NaCMC; Sodium CMC; Carboxy methyl cellulose is the partial sodium salt of a carboxymethyl ether of cellulose, the cellulose being obtained directly from strains of fibrous plant material
Einecs Chemical name Chemical formula Sodium salt of the carboxymethyl ether of cellulose The polymers contain substituted anhydroglucose units with the following general formula: C6H7O2(OR1)(OR2)(OR3), where R1, R2, R3 each may be one of the following: H CH2COONa CH2COOH Molecular weight Higher than approximately 17 000 (degree of polymerisation approxi mately 100) Content on the anhydrous basis not less than 99,5 % Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Assay Description
Identification Solubility Foam test Yields a viscous colloidal solution with water. Insoluble in ethanol A 0,1 % solution of the sample is shaken vigorously. No layer of foam appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers) To 5 ml of a 0,5 % solution of the sample, add 5 ml of 5 % solution of copper sulphate or of aluminium sulphate. A precipitate appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers and from gelatine, locust bean gum and tragacanth) Add 0,5 g powdered carboxy methyl cellulose sodium to 50 ml of water, while stirring to produce an uniform dispersion. Continue the stirring until a clear solution is produced, and use the solution for the following test:
Precipitate formation
Colour reaction
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To 1 mg of the sample, diluted with an equal volume of water, in a small test tube, add 5 drops of 1-naphthol solution. Incline the test tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface pH Purity Degree of substitution Loss on drying Arsenic Lead Mercury Cadmium Total glycolate Sodium Not less than 0,2 and not more than 1,5 carboxymethyl groups (-CH2COOH) per anhydroglucose unit Not more than 12 % (105 C to constant weight) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 0,4 %, calculated as sodium glycolate on the anhydrous basis Not more than 12,4 % on the anhydrous basis Not less than 5,0 and not more than 8,5 (1 % colloidal solution)
E 468 CROSS-LINKED SODIUM CARBOXYMETHYLCELLULOSE, CROSS-LINKED CELLULOSE GUM Synonyms Definition Einecs Chemical name Chemical formula Sodium salt of the cross-linked carboxymethyl ether cellulose The polymers containing substituted anhydroglucose units with the general formula: C6H7O2(OR1)(OR2)(OR3) where R1, R2 and R3 may be any of the following: H CH2COONa CH2COOH Molecular weight Assay Description Identification Precipitate formation Shake 1 g with 100 ml of a solution containing 4 mg/kg methylene blue and allow to settle. The substance to be examined absorbs the methylene blue and settles as a blue, fibrous mass Shake 1 g with 50 ml of water. Transfer 1 ml of the mixture to a test tube, add 1 ml water and 0,05 ml of freshly prepared 40 g/l solution of alpha-naphthol in methanol. Incline the test tube and add carefully 2 ml of sulphuric acid down the side so that it forms a lower layer. A reddish-violet colour develops at the interface Passes test Not less than 5,0 and not more than 7,0 (1 % solution) Slightly hygroscopic, white to off white, odourless powder Cross-linked carboxymethyl cellulose; Cross-linked CMC; Cross-linked sodium CMC; Cross-linked sodium carboxymethyl cellulose is the sodium salt of thermally cross-linked partly O-carboxymethylated cellulose
Colour reaction
Test for sodium pH
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Purity Loss on drying Water soluble matter Degree of substitution Not more than 6 % (105 C, 3 hours) Not more than 10 % Not less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit Not more than 12,4 % on anhydrous basis Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
Sodium content Arsenic Lead Cadmium Mercury
E 469 ENZYMATICALLY HYDROLYSED CARBOXYMETHYLCELLULOSE, ENZYMATICALLY HYDROLISED CELLULOSE GUM Synonyms Definition Sodium carboxymethyl cellulose, enzymatically hydrolysed Enzymatically hydrolysed carboxymethylcellulose is obtained from carboxymethylcellulose by enzymatic digestion with a cellulase produced by Trichoderma longibrachiatum (formerly T. reesei)
Einecs Chemical name Chemical formula Carboxymethyl cellulose, sodium, partially enzymatically hydrolysed Sodium salts of polymers containing substituted anhydroglucose units with the general formula: [C6H7O2(OH)x(OCH2COONa)y]n where n is the degree of polymerisation x = 1,50 to 2,80 y = 0,2 to 1,50 x + y = 3,0 (y = degree of substitution) Molecular weight 178,14 where y = 0,20 282,18 where y = 1,50 Macromolecules: Not less than 800 (n about 4) Assay Not less than 99,5 %, including mono- and disaccharides, on the dried basis
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Description
White or slightly yellowish or greyish, odourless, slightly hygroscopic granular or fibrous powder
Identification Solubility Foam test Soluble in water, insoluble in ethanol Vigorously shake a 0,1 % solution of the sample. No layer of foam appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from alginates and natural gums To 5 ml of a 0,5 % solution of the sample add 5 ml of a 5 % solution of copper or aluminium sulphate. A precipitate appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from gelatine, carob bean gum and tragacanth gum Add 0,5 g of the powdered sample to 50 ml of water, while stirring to produce a uniform dispersion. Continue the stirring until a clear solution is produced. Dilute 1 ml of the solution with 1 ml of water in a small test tube. Add 5 drops of 1-naphthol TS. Incline the tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface Not less than 2 500 kgm 1s 1 at 25 C corresponding to an average molecule weight of 5 000 Da Not less than 6,0 and not more than 8,5 (1 % colloidal solution)
Precipitate formation
Colour reaction
Viscosity (60 % solids)
pH Purity Loss on drying Degree of substitution
Not more than 12 % (105 C to constant weight) Not less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit on the dried basis Not more than 0,5 % singly or in combination Passes test. No change in viscosity of test solution occurs, which indicates hydrolysis of the sodium carboxymethyl cellulose Not more than 3 mg/kg
Sodium chloride and sodium glycolate Residual enzyme activity
Lead
E 470a SODIUM, POTASSIUM AND CALCIUM SALTS OF FATTY ACIDS Synonyms Definition Sodium, potassium and calcium salts of fatty acids occurring in food oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids.
Einecs Chemical name Chemical formula Molecular weight Assay Content on the anhydrous basis not less than 95 % (105 C till a constant weight)
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Description Identification Solubility Test for cations Test for fatty acids Purity Sodium Potassium Calcium Unsaponifiable matter Free fatty acids Arsenic Lead Mercury Cadmium Free alkali Matter insoluble in alcohol
White or creamy white light powders, flakes or semi-solids
Sodium and potassium salts: soluble in water and ethanol. Calcium salts: insoluble in water, ethanol and ether Passes test Passes test
Not less than 9 % and not more than 14 % expressed as Na2O Not less than 13 % and not more than 21,5 % expressed as K2O Not less than 8,5 % and not more than 13 % expressed as CaO Not more than 2 % Not more than 3 % estimated as oleic acid Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 0,1 % expressed as NaOH Not more than 0,2 % (sodium and potassium salts only)
E 470b MAGNESIUM SALTS OF FATTY ACIDS Synonyms Definition Magnesium salts of fatty acids occurring in foods oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Test for magnesium Test for fatty acids Purity Magnesium Free alkali Unsaponifiable matter Free fatty acids Not less than 6,5 % and not more than 11 % expressed as MgO Not more than 0,1 % expressed as MgO Not more than 2 % Not more than 3 % estimated as oleic acid Insoluble in water, partially soluble in ethanol and ether Passes test Passes test Content on the anhydrous basis not less than 95 % (105 C till a constant weight) White or creamy-white light powders, flakes or semi-solids
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E 471 MONO- AND DIGLYCERIDES OF FATTY ACIDS Synonyms Glyceryl monostearate; Glyceryl monopalmitate; Glyceryl monooleate, etc.; Monostearin; Monopalmitin; Monoolein, etc.; GMS (for glyceryl monostearate) Mono- and diglycerides of fatty acids consist of mixtures of glycerol mono-, di- and triesters of fatty acids occurring in food oils and fats. They may contain small amounts of free fatty acids and glycerol
Definition
Einecs Chemical name Chemical formula Molecular weight Assay Description Content of mono- and diesters: not less than 70 % The product varies from a pale yellow to pale brown oily liquid to a white or slightly off-white hard waxy solid. The solids may be in the form of flakes, powders or small beads
Identification Infrared absorption spectrum Test for glycerol Test for fatty acids Solubility Purity Water content Acid value Free glycerol Polyglycerols Arsenic Lead Mercury Cadmium Total glycerol Sulphated ash Not more than 2 % (Karl Fischer method) Not more than 6 Not more than 7 % Not more than 4 % diglycerol and not more than 1 % higher polyglycerols both based on total glycerol content Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not less than 16 % and not more than 33 % Not more than 0,5 % determined at 800 25 C Characteristic of a partial fatty acid ester of a polyol Passes test Passes test Insoluble in water, soluble in ethanol and toluene at 50 C
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
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E 472 a ACETIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS Synonyms Acetic acid esters of mono- and diglycerides; Acetoglycerides; Acetylated mono- and diglycerides; Acetic and fatty acid esters of glycerol Esters of glycerol with acetic and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free acetic acid and free glycerides
Definition
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for glycerol Test for fatty acids Test for acetic acid Solubility Purity Acids other than acetic and fatty acids Free glycerol Arsenic Lead Mercury Cadmium Total acetic acid Free fatty acids (and acetic acid) Total glycerol Sulphated ash Less than 1 % Not more than 2 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not less than 9 % and not more than 32 % Not more than 3 % estimated as oleic acid Not less than 14 % and not more than 31 % Not more than 0,5 % determined at 800 25 C Passes test Passes test Passes test Insoluble in water. Soluble in ethanol Clear, mobile liquids to solids, from white to pale yellow in colour
E 472 b LACTIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS Synonyms Definition Lactic acid esters of mono- and diglycerides; Lactoglycerides; Monoand diglycerides of fatty acids esterified with lactic acid Esters of glycerol with lactic acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free lactic acid and free glycerides Clear, mobile liquids to waxy solids of variable consistency, from white to pale yellow in colour
Description
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Identification Test for glycerol, Test for fatty acids Test for lactic acid Solubility Purity Acids other than lactic and fatty acids Free glycerol Arsenic Lead Mercury Cadmium Total lactic acid Free fatty acids (and lactic acid) Total glycerol Sulphated ash Less than 1 % Not more than 2 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not less than 13 % and not more than 45 % Not more than 3 % estimated as oleic acid Not less than 13 % and not more than 30 % Not more than 0,5 % (800 25 C) Passes test Passes test Passes test Insoluble in cold water but dispersible in hot water
E 472 c CITRIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS Synonyms Definition Citrem; Citric acid esters of mono- and diglycerides; Citroglycerides; Mono- and diglycerides of fatty acids esterified with citric acid Esters of glycerol with citric acid and fatty acids occurring in food oils and fats. They may contain small amounts of free glycerol, free fatty acids, free citric acid and free glycerides. They may be partially or wholly neutralised with sodium, potassium or calcium salts suitable for the purpose and authorised as food additives according to this Regulation.
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for glycerol Test for fatty acids Test for citric acid Solubility Passes test Passes test Passes test Insoluble in cold water, dispersible in hot water, soluble in oils and fats, insoluble in cold ethanol Yellowish or light brown liquids to waxy solids or semi-solids
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Purity Acids other than citric and fatty acids Free glycerol Total glycerol Total citric acid Sulphated ash Less than 1 % Not more than 2 % Not less than 8 % and not more than 33 % Not less than 13 % and not more than 50 % Non-neutralised products: not more than 0,5 % (800 25 C) Partially or wholly neutralised products: not more than 10 % (800 25 C) Lead Acid value Not more than 2 mg/kg Not more than 130
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however, these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
E 472 d TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS Synonyms Definition Tartaric acid esters of mono- and diglycerides; Mono- and diglycerides of fatty acids esterified with tartaric acid Esters of glycerol with tartaric acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric acid and free glycerides
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for glycerol Test for fatty acids Test for tartaric acid Purity Acids other than tartaric and fatty acids Free glycerol Total glycerol Arsenic Lead Mercury Cadmium Total tartaric acid Less than 1,0 % Not more than 2 % Not less than 12 % and not more than 29 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not less than 15 % and not more than 50 % Passes test Passes test Passes test Sticky viscous yellowish liquids to hard yellow waxes
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Free fatty acids Sulphated ash
Not more than 3 % estimated as oleic acid Not more than 0,5 % (800 25 C)
E 472 e MONO- AND DIACETYLTARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS Synonyms Diacetyltartaric acid esters of mono- and diglycerides; Mono-and diglycerides of fatty acids esterified with mono- and diacetyltartaric acid; Diacetyltartaric and fatty acid esters of glycerol Mixed esters of glycerol with mono- and diacetyltartaric acids (obtained from tartaric acid) and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and acetic acids and their combinations, and free glycerides. Contains also tartaric and acetic esters of fatty acids
Definition
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for glycerol Test for fatty acids Test for tartaric acid Test for acetic acid Purity Acids other than acetic, tartaric and fatty acids Free glycerol Total glycerol Sulphated ash Arsenic Lead Mercury Cadmium Total tartaric acid Total acetic acid Acid value Less than 1 % Not more than 2 % Not less than 11 % and not more than 28 % Not more than 0,5 % determined at 800 25 C Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not less than 10 % and not more than 40 % Not less than 8 % and not more than 32 % Not less than 40 and not more than 130 Passes test Passes test Passes test Passes test Sticky viscous liquids through a fat-like consistency to yellow waxes which hydrolyse in moist air to liberate acetic acid
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E 472 f MIXED ACETIC AND TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS Synonyms Mono- and diglycerides of fatty acids esterified with acetic acid and tartaric acid Esters of glycerol with acetic and tartaric acids and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and acetic acids, and free glycerides. May contain mono- and diacetyltartaric esters of mono- and diglycerides of fatty acids
Definition
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for glycerol Test for fatty acids Test for tartaric acid Test for acetic acid Purity Acids other than acetic, tartaric and fatty acids Free glycerol Total glycerol Sulphated ash Arsenic Lead Mercury Cadmium Total acetic acid Total tartaric acid Free fatty acids Less than 1,0 % Passes test Passes test Passes test Passes test Sticky liquids to solids, from white to pale-yellow in colour
Not more than 2 % Not less than 12 % and not more than 27 % Not more than 0,5 % (800 25 C) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not less than 10 % and not more than 20 % Not less than 20 % and not more than 40 % Not more than 3 % estimated as oleic acid
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E 473 SUCROSE ESTERS OF FATTY ACIDS Synonyms Definition Sucroesters; Sugar esters Essentially the mono-, di- and triesters of sucrose with fatty acids occurring in food fats and oils. They may be prepared from sucrose and the methyl, ethyl and vinyl esters of food fatty acids (including lauric acid) or by extraction from sucroglycerides. No organic solvent other than dimethylsulphoxide, dimethylformamide, ethyl acetate, propan-2-ol, 2-methyl-1-propanol, propylene glycol, methyl ethyl ketone and supercritical carbondioxide may be used for their prep aration. p-methoxy phenol can be used as a stabiliser during the manu facturing procedure.
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for sugar Test for fatty acids Solubility Purity Sulphated ash Free sugar Free fatty acids p-methoxy-phenol Acetaldehyde Arsenic Lead Mercury Cadmium Methanol Dimethylsulphoxide Dimethylformamide 2-methyl-1-propanol Ethyl acetate Propan-2-ol Propylene glycol Methyl ethyl ketone Not more than 2 % (800 25 C) Not more than 5 % Not more than 3 % estimated as oleic acid Not more than 100 g/kg Not more than 50 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 10 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 10 mg/kg 9 > > > > = Not more than 350 mg/kg, singly or in combination > > > > ; Not more than 10 mg/kg Passes test Passes test Sparingly soluble in water, soluble in ethanol Content not less than 80 % Stiff gels, soft solids or white to slightly greyish-white powders
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E 474 SUCROGLYCERIDES Synonyms Definition Sugar glycerides Sucroglycerides are produced by reacting sucrose with an edible fat or oil to produce a mixture of essentially mono-, di- and triesters of sucrose and fatty acids (including lauric acid) together with residual mono-, di- and triglycerides from fat or oil. No organic solvents shall be used in their preparation other than cyclohexane, dimethyl formamide, ethyl acetate, 2-methyl-1-propanol and propan-2-ol
Einecs Chemical name Chemical formula Molecular weight Assay Content not less than 40 % and not more than 60 % of sucrose fatty acid esters Soft solid masses, stiff gels or white to off-white powders
Description Identification Test for sugar Test for fatty acids Solubility Purity Sulphated ash Free sugar Free fatty acids Arsenic Lead Mercury Cadmium Methanol Dimethylformamide 2-Methyl-1-propanol Cyclohexane Ethyl acetate Propan-2-ol
Passes test Passes test Insoluble in cold water, soluble in ethanol
Not more than 2 % (800 25 C) Not more than 5 % Not more than 3 % (estimated as oleic acid) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 10 mg/kg Not more than 1 mg/kg 9 > = > ; 9 > = > ;
Not more than 10 mg/kg, single or in combination
Not more than 350 mg/kg, single or in combination
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E 475 POLYGLYCEROL ESTERS OF FATTY ACIDS Synonyms Definition Polyglycerol fatty acid esters; Polyglycerin esters of fatty acid esters Polyglycerol esters of fatty acids are produced by the esterification of polyglycerol with food fats and oils or with fatty acids occurring in foods fats and oils. The polyglycerol moiety is predominantly di-, triand tetraglycerol and contains not more than 10 % of polyglycerols equal to or higher than heptaglycerol
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for glycerol, Test for polyglycerols Test for fatty acids Solubility Purity Sulphated ash Acids other than fatty acids Free fatty acids Total glycerol and polyglycerol Free glycerol and polyglycerol Arsenic Lead Mercury Cadmium Not more than 0,5 % (800 25 C) Less than 1 % Not more than 6 % estimated as oleic acid Not less than 18 % and not more than 60 % Not more than 7 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Passes test Passes test Passes test The esters range from very hydrophilic to very lipophilic, but as a class tend to be dispersible in water and soluble in organic solvents and oils Content of total fatty acid ester not less than 90 % Light yellow to amber, oily to very viscous liquids; light tan to medium brown, plastic or soft solids; and light tan to brown, hard, waxy solids
E 476 POLYGLYCEROL POLYRICINOLEATE Synonyms Glycerol esters of condensed castor oil fatty acids; Polyglycerol esters of polycondensed fatty acids from castor oil; Polyglycerol esters of inter esterified ricinoleic acid; PGPR Polyglycerol polyricinoleate is prepared by the esterification of poly glycerol with condensed castor oil fatty acids
Definition
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Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Test for glycerol Test for polyglycerol Test for ricinoleic acid Refractive index Purity Polyglycerols The polyglycerol moiety shall be composed of not less than 75 % of di-, tri- and tetraglycerols and shall contain not more than 10 % of polyglycerols equal to or higher than heptaglycerol Not less than 80 and not more than 100 Not more than 6 Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Insoluble in water and in ethanol; soluble in ether, hydrocarbons and halogenated hydrocarbons Passes test Passes test Passes test [n]D65 between 1,4630 and 1,4665 Clear, highly viscous liquid
Hydroxyl value Acid value Arsenic Lead Mercury Cadmium
E 477 PROPANE-1,2-DIOL ESTERS OF FATTY ACIDS Synonyms Definition Propylene glycol esters of fatty acids Consists of mixtures of propane-1,2-diol mono- and diesters of fatty acids occurring in food fats and oils. The alcohol moiety is exclusively propane-1,2-diol together with dimer and traces of trimer. Organic acids other than food fatty acids are absent
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for propylene glycol Test for fatty acids Passes test Passes test Content of total fatty acid ester not less than 85 % Clear liquids or waxy white flakes, beads or solids having a bland odour
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Purity Sulphated ash Acids other than fatty acids Free fatty acids Total propane-1,2-diol Free propane-1,2-diol Dimer and trimer of propylene glycol Arsenic Lead Mercury Cadmium Not more than 0,5 % (800 25 C) Less than 1 % Not more than 6 % estimated as oleic acid Not less than 11 % and not more than 31 % Not more than 5 % Not more than 0,5 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 479 b THERMALLY OXIDISED SOYA BEAN OIL INTERACTED WITH MONO- AND DIGLYCERIDES OF FATTY ACIDS Synonyms Definition TOSOM Thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids is a complex mixture of esters of glycerol and fatty acids found in edible fat and fatty acids from thermally oxidised soya bean oil. It is produced by interaction and deodorisation under vacuum at 130 C of 10 % of thermally oxidised soya bean oil and 90 % mono- and diglycerides of food fatty acids. Soya bean oil is exclusively made from strains of soya beans
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Purity Melting range Free fatty acids Free glycerol Total fatty acids Total glycerol 55-65 C Not more than 1,5 % estimated as oleic acid Not more than 2 % 83-90 % 16-22 % Insoluble in water. Soluble in hot oil or fat Pale yellow to light brown a waxy or solid consistency
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Fatty acid methyl esters, not forming adduct with urea Fatty acids, insoluble in petroleum ether Peroxide value Epoxides Arsenic Lead Mercury Cadmium
Not more than 9 % of total fatty acid methyl esters Not more than 2 % of total fatty acids Not more than 3 Not more than 0,03 % oxirane oxygen Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 481 SODIUM STEAROYL-2-LACTYLATE Synonyms Definition Sodium stearoyl lactylate; Sodium stearoyl lactate A mixture of the sodium salts of stearoyl lactylic acids and its polymers and minor amounts of sodium salts of other related acids, manu factured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used 246-929-7 Sodium di-2-stearoyl lactate Sodium di(2-stearoyloxy)propionate Chemical formula Molecular weight Assay Description Identification Test for sodium Test for fatty acids Test for lactic acid Solubility Purity Sodium Ester value Acid value Total lactic acid Arsenic Lead Mercury Cadmium Not less than 2,5 % and not more than 5 % Not less than 90 and not more than 190 Not less than 60 and not more than 130 Not less than 15 % and not more than 40 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Passes test Passes test Passes test Insoluble in water. Soluble in ethanol White or slightly yellowish powder or brittle solid with a characteristic odour C21H39O4Na; C19H35O4Na (major components)
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E 482 CALCIUM STEAROYL-2-LACTYLATE Synonyms Definition Calcium stearoyl lactate A mixture of the calcium salts of stearoyl lactylic acids and its polymers and minor amounts of calcium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used 227-335-7 Calcium di-2-stearoyl lactate Calcium di(2-stearoyloxy)propionate Chemical formula Molecular weight Assay Description Identification Test for calcium Test for fatty acids Test for lactid acid Solubility Purity Calcium Ester value Total lactic acid Acid value Arsenic Lead Mercury Cadmium Not less than 1 % and not more than 5,2 % Not less than 125 and not more than 190 Not less than 15 % and not more than 40 % Not less than 50 and not more than 130 Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Passes test Passes test Passes test Slightly soluble in hot water White or slightly yellowish powder or brittle solid with a characteristic odour C42H78O8Ca; C38H70O8Ca, C40H74O8Ca (major components)
E 483 STEARYL TARTRATE Synonyms Definition Stearyl palmityl tartrate Product of the esterification of tartaric acid with commercial stearyl alcohol, which consists essentially of stearyl and palmityl alcohols. It consists mainly of diester, with minor amounts of monoester and of unchanged starting materials
Einecs Chemical name Distearyl tartrate Dipalmityl tartrate Stearylpalmityl tartrate
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Chemical formula
C40H78O6 (Distearyl tartrate) C36H70O6 (Dipalmityl tartrate) C38H74O6 (Stearylpalmityl tartrate)
Molecular weight
655 (Distearyl tartrate) 599 (Dipalmityl tartrate) 627 (Stearylpalmityl tartrate)
Assay Description Identification Test for tartrate Melting range Purity Hydroxyl value Acid value Total tartaric acid Sulphated ash Arsenic Lead Mercury Cadmium Unsaponifiable matter Iodine value
Content of total ester not less than 90 % corresponding to an ester value of not less than 163 and not more than 180 Cream-coloured unctuous solid (at 25 C)
Passes test Between 67 C and 77 C. After saponification the saturated long chain fatty alcohols have a melting range of 49 C to 55 C
Not less than 200 and not more than 220 Not more than 5,6 Not less than 18 % and not more than 35 % Not more than 0,5 % (800 25 C) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not less than 77 % and not more than 83 % Not more than 4 (Wijs method)
E 491 SORBITAN MONOSTEARATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters Light, cream- to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid 215-664-9
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Identification Solubility Soluble at temperatures above its melting point in toluene, dioxane, carbon tetrachloride, ether, methanol, ethanol and aniline; insoluble in petroleum ether and acetone; insoluble in cold water but dispersible in warm water; soluble with haze at temperatures above 50 C in mineral oil and ethyl acetate 50-52 C Characteristic of a partial fatty acid ester of a polyol
Congealing range Infrared absorption spectrum Purity Water content Sulphated ash Acid value Saponification value Hydroxyl value Arsenic Lead Mercury Cadmium
Not more than 2 % (Karl Fischer method) Not more than 0,5 % Not more than 10 Not less than 147 and not more than 157 Not less than 235 and not more than 260 Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 492 SORBITAN TRISTEARATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Slightly soluble in toluene, ether, carbon tetrachloride and ethyl acetate; dispersible in petroleum ether, mineral oil, vegetable oils, acetone and dioxane; insoluble in water, methanol and ethanol 47-50 C Characteristic of a partial fatty acid ester of a polyol Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters Light, cream- to tan-coloured beads or flakes or hard, waxy solid with a slight odour A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid 247-891-4
Congealing range Infrared absorption spectrum Purity Water content Sulphated ash
Not more than 2 % (Karl Fischer method) Not more than 0,5 %
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Acid value Saponification value Hydroxyl value Arsenic Lead Mercury Cadmium
Not more than 15 Not less than 176 and not more than 188 Not less than 66 and not more than 80 Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 493 SORBITAN MONOLAURATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Infrared absorption spectrum Purity Water content Sulphated ash Acid value Saponification value Hydroxyl value Arsenic Lead Mercury Cadmium Not more than 2 % (Karl Fischer method) Not more than 0,5 % Not more than 7 Not less than 155 and not more than 170 Not less than 330 and not more than 358 Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Dispersible in hot and cold water Characteristic of a partial fatty acid ester of a polyol Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters Amber-coloured oily viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight odour A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial lauric acid 215-663-3
E 494 SORBITAN MONOOLEATE Synonyms Definition A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial oleic acid. Major constituent is 1,4-sorbitan mono oleate. Other constituents include isosorbide monooleate, sorbitan dioleate and sorbitan trioleate
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Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility
215-665-4
Content not less than 95 % of a mixture of sorbitol, sorbitan and isosorbide esters Amber-coloured viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour
Soluble at temperatures above its melting point in ethanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water, dispersible in warm water The residue of oleic acid, obtained from the saponification of the sorbitan monooleate in assay, has a iodine value between 80 and 100
Iodine value Purity Water content Sulphated ash Acid value Saponification value Hydroxyl value Arsenic Lead Mercury Cadmium
Not more than 2 % (Karl Fischer method) Not more than 0,5 % Not more than 8 Not less than 145 and not more than 160 Not less than 193 and not more than 210 Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 495 SORBITAN MONOPALMITATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Soluble at temperatures above its melting point in ethanol, methanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water but dispersible in warm water Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters Light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour Sorbitan palmitate A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial palmitic acid 247-568-8
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Congealing range Infrared absorption spectrum Purity Water content Sulphate ash Acid value Saponification value Hydroxyl value Arsenic Lead Mercury Cadmium
45-47 C Characteristic of a partial fatty acid ester of polyol
Not more than 2 % (Karl Fischer method) Not more than 0,5 % Not more than 7,5 Not less than 140 and not more than 150 Not less than 270 and not more than 305 Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 500 (i) SODIUM CARBONATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description 207-838-8 Sodium carbonate Na2CO3 nH2O (n = 0, 1 or 10) 106,00 (anhydrous) Content not less than 99 % of Na2CO3 on the anhydrous basis Colourless crystals or white, granular or crystalline powder The anhydrous form is hygroscopic, the decahydrate efflorescent Identification Test for sodium Test for carbonate Solubility Purity Loss on drying Not more than 2 % (anhydrous), 15 % (monohydrate) or 55 %-65 % (decahydrate) (70 C raising gradually to 300 C, to constant weight) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Passes test Passes test Freely soluble in water. Insoluble in ethanol Soda ash
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E 500 (ii) SODIUM HYDROGEN CARBONATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for sodium Test for carbonate pH Solubility Purity Loss on drying Ammonium salts Arsenic Lead Mercury Not more than 0,25 % (over silica gel, 4 hours) No odour of ammonia detectable after heating Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Passes test Passes test Between 8,0 and 8,6 (1 % solution) Soluble in water. Insoluble in ethanol 205-633-8 Sodium hydrogen carbonate NaHCO3 84,01 Content not less than 99 % on the anhydrous basis Colourless or white crystalline masses or crystalline powder Sodium bicarbonate; sodium acid carbonate; Bicarbonate of soda; Baking soda
E 500 (iii) SODIUM SESQUICARBONATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for sodium Test for carbonate Solubility Passes test Passes test Freely soluble in water 208-580-9 Sodium monohydrogen dicarbonate Na2CO3 NaHCO3 2H2O 226,03 Content between 35,0 % and 38,6 % of NaHCO3 and between 46,4 % and 50,0 % of Na2CO3 White flakes, crystals or crystalline powder
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Purity Sodium chloride Iron Arsenic Lead Mercury Not more than 0,5 % Not more than 20 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 501 (i) POTASSIUM CARBONATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description 209-529-3 Potassium carbonate K2CO3 nH2O (n = 0 or 1,5) 138,21 (anhydrous) Content not less than 99,0 % on the anhydrous basis White, very deliquescent powder. The hydrate occurs as small, white, translucent crystals or granules Identification Test for potassium Test for carbonate Solubility Purity Loss on drying Arsenic Lead Mercury Not more than 5 % (anhydrous) or 18 % (hydrate) (180 C, 4 hours) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Passes test Passes test Very soluble in water. Insoluble in ethanol
E 501 (ii) POTASSIUM HYDROGEN CARBONATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 206-059-0 Potassium hydrogen carbonate KHCO3 100,11 Content not less than 99,0 % and not more than 101,0 % KHCO3 on the anhydrous basis Potassium bicarbonate; Acid potassium carbonate
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Description Identification Test for potassium Test for carbonate Solubility Purity Loss on drying Arsenic Lead Mercury
Colourless crystals or white powder or granules
Passes test Passes test Freely soluble in water. Insoluble in ethanol
Not more than 0,25 % (over silica gel, 4 hours) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 503 (i) AMMONIUM CARBONATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Ammonium carbonate consists of ammonium carbamate, ammonium carbonate and ammonium hydrogen carbonate in varying proportions 233-786-0 Ammonium carbonate CH6N2O2, CH8N2O3 and CH5NO3 Ammonium carbamate 78,06; ammonium ammonium hydrogen carbonate 79,06 carbonate 98,73;
Content not less than 30,0 % and not more than 34,0 % of NH3 White powder or hard, white or translucent masses or crystals. Becomes opaque on exposure to air and is finally converted into white porous lumps or powder (of ammonium bicarbonate) due to loss of ammonia and carbon dioxide
Identification Test for ammonium Test for carbonate pH Solubility Purity Non-volatile matter Chlorides Sulphate Arsenic Lead Mercury Not more than 500 mg/kg Not more than 30 mg/kg Not more than 30 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Passes test Passes test About 8,6 (5 % solution) Soluble in water
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E 503 (ii) AMMONIUM HYDROGEN CARBONATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for ammonium Test for carbonate pH Solubility Purity Non-volatile matter Chlorides Sulphate Arsenic Lead Mercury Not more than 500 mg/kg Not more than 30 mg/kg Not more than 30 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Passes test Passes test About 8,0 (5 % solution) Freely soluble in water. Insoluble in ethanol 213-911-5 Ammonium hydrogen carbonate CH5NO3 79,06 Content not less than 99,0 % White crystals or crystalline powder Ammonium bicarbonate
E 504 (i) MAGNESIUM CARBONATE Synonyms Definition Einecs Chemical name Chemical formula Assay Description Identification Test for magnesium Test for carbonate Solubility Passes test Passes test Practically insoluble both in water or ethanol Hydromagnesite Magnesium carbonate is a basic hydrated or a monohydrated magnesium carbonate or a mixture of the two. 208-915-9 Magnesium carbonate MgCO3 nH2O Not less than 24 % and not more than 26,4 % of Mg Odourless, light, white friable masses or as a bulky white powder
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Purity Acid insoluble matter Water soluble matter Calcium Arsenic Lead Mercury Not more than 0,05 % Not more than 1,0 % Not more than 0,4 % Not more than 4 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 504 (ii) MAGNESIUM HYDROXIDE CARBONATE Synonyms Magnesium hydrogen carbonate; Magnesium subcarbonate (light or heavy); Hydrated basic magnesium carbonate; Magnesium carbonate hydroxide
Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for magnesium Test for carbonate Solubility Purity Acid insoluble matter Water soluble matter Calcium Arsenic Lead Mercury Not more than 0,05 % Not more than 1,0 % Not more than 1,0 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Passes test Passes test Practically insoluble in water. Insoluble in ethanol 235-192-7 Magnesium carbonate hydroxide hydrated 4MgCO3Mg(OH)2 5H2O 485 Mg content not less than 40,0 % and not more than 45,0 % calculated as MgO Light, white friable mass or bulky white powder
E 507 HYDROCHLORIC ACID Synonyms Definition Einecs Chemical name Chemical formula Molecular weight 231-595-7 Hydrochloric acid HCl 36,46 Hydrogen chloride; Muriatic acid
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Assay Description Identification Test for acid Test for chloride Solubility Purity Total organic compounds
Hydrochloric acid is commercially available in varying concentrations. Concentrated hydrochloric acid contains not less than 35,0 % HCl Clear, colourless or slightly yellowish, corrosive liquid having a pungent odour
Passes test Passes test Soluble in water and in ethanol
Total organic compounds (non-fluorine containing): not more than 5 mg/kg Benzene: not more than 0,05 mg/kg Fluorinated compounds (total): not more than 25 mg/kg
Non-volatile matter Reducing substances Oxidising substances Sulphate Iron Arsenic Lead Mercury
Not more than 0,5 % Not more than 70 mg/kg (as SO2) Not more than 30 mg/kg (as Cl2) Not more than 0,5 % Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 508 POTASSIUM CHLORIDE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description 231-211-8 Potassium chloride KCl 74,56 Content not less than 99 % on the dried basis Colourless, elongated, prismatic or cubital crystals or white granular powder. Odourless Sylvine; Sylvite
Identification Solubility Test for potassium Test for chloride Freely soluble in water. Insoluble in ethanol Passes test Passes test
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Purity Loss on drying Test for sodium Arsenic Lead Mercury Cadmium Not more than 1 % (105 C, 2 hours) Negative Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 509 CALCIUM CHLORIDE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for calcium Test for chloride Solubility Purity Magnesium and alkali salts Fluoride Arsenic Lead Mercury Not more than 5 % on the dried basis (calculated as sulphates) Not more than 40 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Passes test Passes test Soluble in water and in ethanol 233-140-8 Calcium chloride CaCl2 nH2O (n = 0,2 or 6) 110,99 (anhydrous), 147,02 (dihydrate), 219,08 (hexahydrate) Content not less than 93,0 % on the anhydrous basis White, odourless, hygroscopic powder or deliquescent crystals
E 511 MAGNESIUM CHLORIDE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 232-094-6 Magnesium chloride MgCl2 6H2O 203,30 Content not less than 99,0 %
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Description Identification Test for magnesium Test for chloride Solubility Purity Ammonium Arsenic Lead Mercury
Colourless, odourless, very deliquescent flakes or crystals
Passes test Passes test Very soluble in water, freely soluble in ethanol
E 512 STANNOUS CHLORIDE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description 231-868-0 Stannous chloride dihydrate SnCl2 2H2O 225,63 Content not less than 98,0 % Colourless or white crystals May have a slight odour of hydrochloric acid Identification Test for tin (II) Test for chloride Solubility Passes test Passes test Water: soluble in less than its own weight of water, but it forms an insoluble basic salt with excess water Ethanol: soluble Purity Sulphate Arsenic Mercury Lead Not more than 30 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 2 mg/kg Tin chloride; Tin dichloride
E 513 SULPHURIC ACID Synonyms Definition Einecs Chemical name 231-639-5 Sulphuric acid Oil of vitriol; Dihydrogen sulphate
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Chemical formula Molecular weight Assay Description Identification Test for acid Test for sulphate Solubility Purity Ash Reducing matter Nitrate Chloride Iron Selenium Arsenic Lead Mercury
H2SO4 98,07 Sulphuric acid is commercially available in varying concentrations. The concentrated form contains not less than 96,0 % Clear, colourless or slightly brown, very corrosive oily liquid
Passes test Passes test Miscible with water, with generation of much heat, also with ethanol
Not more than 0,02 % Not more than 40 mg/kg (as SO2) Not more than 10 mg/kg (on H2SO4 basis) Not more than 50 mg/kg Not more than 20 mg/kg Not more than 20 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 514 (i) SODIUM SULPHATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Sodium sulphate Na2SO4 nH2O (n = 0 or 10) 142,04 (anhydrous) 322,04 (decahydrate) Assay Description Content not less than 99,0 % on the anhydrous basis Colourless crystals or a fine, white, crystalline powder The decahydrate is efflorescent Identification Test for sodium Test for sulphate pH Passes test Passes test Neutral or slightly alkaline to litmus paper (5 % solution)
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L 83/215
Purity Loss on drying Selenium Arsenic Lead Mercury Not more than 1,0 % (anhydrous) or not more than 57 % (decahydrate) at 130 C Not more than 30 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 514 (ii) SODIUM HYDROGEN SULPHATE Synonyms Definition Chemical name Chemical formula Molecular weight Assay Description Identification Test for sodium Test for sulphate pH Purity Loss on drying Water insoluble matter Selenium Arsenic Lead Mercury Not more than 0,8 % Not more than 0,05 % Not more than 30 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Passes test Passes test Solutions are strongly acidic Sodium hydrogen sulphate NaHSO4 120,06 Content not less than 95,2 % White, odourless crystals or granules Acid sodium sulphate; Sodium bisulphate; Nitre cake
E 515 (i) POTASSIUM SULPHATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Potassium sulphate K2SO4 174,25 Content not less than 99,0 %
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Description Identification Test for potassium Test for sulphate pH Solubility Purity Selenium Arsenic Lead Mercury
Colourless or white crystals or crystalline powder
Passes test Passes test Between 5,5 and 8,5 (5 % solution) Freely soluble in water, insoluble in ethanol
E 515 (ii) POTASSIUM HYDROGEN SULPHATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Melting point Test for potassium Solubility Purity Selenium Arsenic Lead Mercury Not more than 30 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg 197 C Passes test Freely soluble in water, insoluble in ethanol Potassium hydrogen sulphate KHSO4 136,17 Content not less than 99 % White deliquescent crystals, pieces or granules Potassium bisulphate; Potassium acid sulphate
E 516 CALCIUM SULPHATE Synonyms Definition Einecs Chemical name 231-900-3 Calcium sulphate Gypsum; Selenite; Anhydrite
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Chemical formula Molecular weight Assay Description Identification Test for calcium Test for sulphate Solubility Purity Loss on drying
CaSO4 nH2O (n = 0 or 2) 136,14 (anhydrous), 172,18 (dihydrate) Content not less than 99,0 % on the anhydrous basis Fine, white to slightly yellowish-white odourless powder
Passes test Passes test Slightly soluble in water, insoluble in ethanol
Anhydrous: not more than 1,5 % (250 C, constant weight) Dihydrate: not more than 23 % (250 C, constant weight)
Fluoride Selenium Arsenic Lead Mercury
E 517 AMMONIUM SULPHATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for ammonium Test for sulphate Solubility Purity Loss on ignition Selenium Lead Not more than 0,25 % Not more than 30 mg/kg Not more than 3 mg/kg Passes test Passes test Freely soluble in water, insoluble in ethanol 231-984-1 Ammonium sulphate (NH4)2SO4 132,14 Content not less than 99,0 % and not more than 100,5 % White powder, shining plates or crystalline fragments
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E 520 ALUMINIUM SULPHATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for aluminium Test for sulphate pH Solubility Purity Loss on ignition Alkalies and alkaline earths Selenium Fluoride Arsenic Lead Mercury Not more than 5 % (500 C, 3 hours) Not more than 0,4 % Not more than 30 mg/kg Not more than 30 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Passes test Passes test 2,9 or above (5 % solution) Freely soluble in water, insoluble in ethanol Aluminium sulphate Al2(SO4)3 342,13 Content not less than 99,5 % on the ignited basis White powder, shining plates or crystalline fragments Alum
E 521 ALUMINIUM SODIUM SULPHATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for aluminium Test for sodium Passes test Passes test 233-277-3 Aluminium sodium sulphate AlNa(SO4)2 nH2O (n = 0 or 12) 242,09 (anhydrous) Content on the anhydrous basis not less than 96,5 % (anhydrous) and 99,5 % (dodecahydrate) Transparent crystals or white crystalline powder Soda alum; Sodium alum
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L 83/219
Test for sulphate Solubility Purity Loss on drying
Passes test Dodecahydrate is freely soluble in water. The anhydrous form is slowly soluble in water. Both forms are insoluble in ethanol
Anhydrous form: not more than 10,0 % (220 C, 16 hours) Dodecahydrate: not more than 47,2 % (50-55 C, 1 hour then 200 C, 16 hours)
Ammonium salts Selenium Fluoride Arsenic Lead Mercury
No odour of ammonia detectable after heating Not more than 30 mg/kg Not more than 30 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg
E 522 ALUMINIUM POTASSIUM SULPHATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for aluminium Test for potassium Test for sulphate pH Solubility Purity Ammonium salts Selenium Fluoride Arsenic Lead Mercury No odour of ammonia detectable after heating Not more than 30 mg/kg Not more than 30 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Passes test Passes test Passes test Between 3,0 and 4,0 (10 % solution) Freely soluble in water, insoluble in ethanol 233-141-3 Aluminium potassium sulphate dodecahydrate AlK(SO4)2 12 H2O 474,38 Content not less than 99,5 % Large, transparent crystals or white crystalline powder Potassium alum; Potash alum
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E 523 ALUMINIUM AMMONIUM SULPHATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for aluminium Test for ammonium Test for sulphate Solubility Purity Alkali metals and alkaline earths Selenium Fluoride Arsenic Lead Mercury Not more than 0,5 % Not more than 30 mg/kg Not more than 30 mg/kg Not more than 3 mg/kg Not more than 3 mg/kg Not more than 1 mg/kg Passes test Passes test Passes test Freely soluble in water, soluble in ethanol 232-055-3 Aluminium ammonium sulphate AlNH4(SO4)2 12 H2O 453,32 Content not less than 99,5 % Large, colourless crystals or white powder Ammonium alum
E 524 SODIUM HYDROXIDE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 215-185-5 Sodium hydroxide NaOH 40,0 Content of solid forms not less than 98,0 % of total alkali (as NaOH). Content of solutions accordingly, based on the stated or labelled percentage of NaOH White or nearly white pellets, flakes, sticks, fused masses or other forms. Solutions are clear or slightly turbid, colourless or slightly coloured, strongly caustic and hygroscopic and when exposed to the air they absorb carbon dioxide, forming sodium carbonate Caustic soda; Lye
Description
Identification Test for sodium pH Solubility Passes test Strongly alkaline (1 % solution) Very soluble in water. Freely soluble in ethanol
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Purity Water insoluble and organic matter Carbonate Arsenic Lead Mercury A 5 % solution is completely clear and colourless to slightly coloured Not more than 0,5 % (as Na2CO3) Not more than 3 mg/kg Not more than 0,5 mg/kg Not more than 1 mg/kg
E 525 POTASSIUM HYDROXIDE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for potassium pH Solubility Purity Water insoluble matter Carbonate Arsenic Lead Mercury A 5 % solution is completely clear and colourless Not more than 3,5 % (as K2CO3) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Passes test Strongly alkaline (1 % solution) Very soluble in water. Freely soluble in ethanol 215-181-3 Potassium hydroxide KOH 56,11 Content not less than 85,0 % of alkali calculated as KOH White or nearly white pellets, flakes, sticks, fused masses or other forms Caustic potash
E 526 CALCIUM HYDROXIDE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 215-137-3 Calcium hydroxide Ca(OH)2 74,09 Content not less than 92,0 % Slaked lime; Hydrated lime
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Description Identification Test for alkali Test for calcium Solubility Purity Acid insoluble ash Magnesium and alkali salts Barium Fluoride Arsenic Lead
White powder
Passes test Passes test Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol
Not more than 1,0 % Not more than 2,7 % Not more than 300 mg/kg Not more than 50 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg
E 527 AMMONIUM HYDROXIDE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for ammonia Purity Non-volatile matter Arsenic Lead Not more than 0,02 % Not more than 3 mg/kg Not more than 2 mg/kg Passes test Ammonium hydroxide NH4OH 35,05 Content not less than 27 % of NH3 Clear, colourless solution, having an exceedingly pungent, characteristic odour Aqua ammonia; Strong ammonia solution
E 528 MAGNESIUM HYDROXIDE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Magnesium hydroxide Mg(OH)2 58,32 Content not less than 95,0 % on the anhydrous basis
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L 83/223
Description Identification Test for magnesium Test for alkali Solubility Purity Loss on drying Loss on ignition Calcium oxide Arsenic Lead
Odourless, white bulky powder
Passes test Passes test Practically insoluble in water and in ethanol
Not more than 2,0 % (105 C, 2 hours) Not more than 33 % (800 C to constant weight) Not more than 1,5 % Not more than 3 mg/kg Not more than 2 mg/kg
E 529 CALCIUM OXIDE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for alkali Test for calcium Reaction with water Solubility Purity Loss on ignition Acid insoluble matter Barium Magnesium and alkali salts Fluoride Arsenic Lead Not more than 10,0 % (ca. 800 C to constant weight) Not more than 1,0 % Not more than 300 mg/kg Not more than 3,6 % Not more than 50 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Passes test Passes test Heat is generated on moistening the sample with water Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol 215-138-9 Calcium oxide CaO 56,08 Content not less than 95,0 % on the ignited basis Odourless, hard, white or greyish white masses of granules, or white to greyish powder Burnt lime
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E 530 MAGNESIUM OXIDE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description 215-171-9 Magnesium oxide MgO 40,31 Content not less than 98,0 % on the ignited basis A very bulky, white powder known as light magnesium oxide or a relative dense, white powder known as heavy magnesium oxide. 5 g of light magnesium oxide occupy a volume of at least 33 ml, while 5 g of heavy magnesium oxide occupy a volume of not more than 20 ml
Identification Test for alkali Test for magnesium Solubility Purity Loss on ignition Calcium oxide Arsenic Lead Not more than 5,0 % (ca. 800 C to constant weight) Not more than 1,5 % Not more than 3 mg/kg Not more than 2 mg/kg Passes test Passes test Practically insoluble in water. Insoluble in ethanol
E 535 SODIUM FERROCYANIDE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for sodium Test for ferrocyanide Purity Free moisture Water insoluble matter Chloride Not more than 1,0 % Not more than 0,03 % Not more than 0,2 % Passes test Passes test 237-081-9 Sodium ferrocyanide Na4Fe(CN)6 10 H2O 484,1 Content not less than 99,0 % Yellow crystals or crystalline powder Yellow prussiate of soda; Sodium hexacyanoferrate
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Sulphate Free cyanide Ferricyanide Lead
Not more than 0,1 % Not detectable Not detectable Not more than 5 mg/kg
E 536 POTASSIUM FERROCYANIDE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for potassium Test for ferrocyanide Purity Free moisture Water insoluble matter Chloride Sulphate Free cyanide Ferricyanide Lead Not more than 1,0 % Not more than 0,03 % Not more than 0,2 % Not more than 0,1 % Not detectable Not detectable Not more than 5 mg/kg Passes test Passes test 237-722-2 Potassium ferrocyanide K4Fe(CN)6 3 H2O 422,4 Content not less than 99,0 % Lemon yellow crystals Yellow prussiate of potash; Potassium hexacyanoferrate
E 538 CALCIUM FERROCYANIDE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for calcium Test for ferrocyanide Passes test Passes test 215-476-7 Calcium ferrocyanide Ca2Fe(CN)6 12H2O 508,3 Content not less than 99,0 % Yellow crystals or crystalline powder Yellow prussiate of lime; Calcium hexacyanoferrate
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Purity Free moisture Water insoluble matter Chloride Sulphate Free cyanide Ferricyanide Lead Not more than 1,0 % Not more than 0,03 % Not more than 0,2 % Not more than 0,1 % Not detectable Not detectable Not more than 5 mg/kg
E 541 SODIUM ALUMINIUM PHOSPHATE, ACIDIC Synonyms Definition Einecs Chemical name Chemical formula 232-090-4 Sodium trialuminium tetradecahydrogen octaphosphate tetrahydrate (A); Trisodium dialuminium pentadecahydrogen octaphosphate (B) NaAl3H14(PO4)8 4H2O (A) Na3Al2H15(PO4)8 (B) Molecular weight 949,88 (A) 897,82 (B) Assay Description Identification Test for sodium Test for aluminium Test for phosphate pH Solubility Purity Loss on ignition 19,5-21,0 % (A) (750-800 C, 2 hours) 15-16 % (B) (750-800 C, 2 hours) Fluoride Arsenic Lead Cadmium Mercury Not more than 25 mg/kg Not more than 3 mg/kg Not more than 4 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Passes test Passes test Passes test Acid to litmus Insoluble in water. Soluble in hydrochloric acid Content not less than 95,0 % (both forms) White odourless powder SALP
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E 551 SILICON DIOXIDE Synonyms Definition Silica; Silicium dioxide Silicon dioxide is an amorphous substance, which is produced synthetically by either a vapour-phase hydrolysis process, yielding fumed silica, or by a wet process, yielding precipitated silica, silica gel, or hydrous silica. Fumed silica is produced in essentially an anhydrous state, whereas the wet-process products are obtained as hydrates or contain surface absorbed water 231-545-4 Silicon dioxide (SiO2)n 60,08 (SiO2) Content after ignition not less than 99,0 % (fumed silica) or 94,0 % (hydrated forms) White, fluffy powder or granules. Hygroscopic
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for silica Purity Loss on drying
Positive
Not more than 2,5 % (fumed silica, 105 C, 2 hours) Not more than 8,0 % (precipitated silica and silica gel, 105 C, 2 hours) Not more than 70 % (hydrous silica, 105 C, 2 hours)
Loss on ignition
Not more than 2,5 % after drying (1 000 C, fumed silica) Not more than 8,5 % after drying (1 000 C, hydrated forms)
Soluble ionisable salts Arsenic Lead Mercury
Not more than 5,0 % (as Na2SO4) Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg
E 552 CALCIUM SILICATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Content on the anhydrous basis: as SiO2 not less than 50 % and not more than 95 % as CaO not less than 3 % and not more than 35 % Description White to off-white free-flowing powder that remains so after absorbing relatively large amounts of water or other liquids Calcium silicate is a hydrous or anhydrous silicate with varying proportions of CaO and SiO2. The product should be free of asbestos. 215-710-8 Calcium silicate
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Identification Test for silicate Test for calcium Gel formation Purity Loss on drying Loss on ignition Sodium Fluoride Arsenic Lead Mercury Not more than 10 % (105 C, 2 hours) Not less than 5 % and not more than 14 % (1 000 C, constant weight) Not more than 3 % Not more than 50 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Passes test Passes test Forms a gel with mineral acids
E 553a (i) MAGNESIUM SILICATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for magnesium Test for silicate pH Purity Loss on drying Loss on ignition Water soluble salts Free alkali Fluoride Arsenic Lead Mercury Not more than 15 % (105 C, 2 hours) Not more than 15 % after drying (1 000 C, 20 min) Not more than 3 % Not more than 1 % (as NaOH) Not more than 10 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Passes test Passes test Between 7,0 and 10,8 (10 % slurry) Content not less than 15 % of MgO and not less than 67 % of SiO2 on the ignited basis Very fine, white, odourless powder, free from grittiness Magnesium silicate is a synthetic compound of which the molar ratio of magnesium oxide to silicon dioxide is approximately 2:5
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E 553a (ii) MAGNESIUM TRISILICATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for magnesium Test for silicate pH Purity Loss on ignition Water soluble salts Free alkali Fluoride Arsenic Lead Mercury Not less than 17 % and not more than 34 % (1 000 C) Not more than 2 % Not more than 1 % (as NaOH) Not more than 10 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Passes test Passes test Between 6,3 and 9,5 (5 % slurry) Content not less than 29,0 % of MgO and not less than 65,0 % of SiO2 both on the ignited basis Fine, white powder, free from grittiness 239-076-7 Magnesium trisilicate Mg2Si3O8 nH2O (approximate composition)
E 553b TALC Synonyms Definition Talcum Naturally occurring form of hydrous magnesium silicate containing varying proportions of such associated minerals as alpha-quartz, calcite, chlorite, dolomite, magnesite, and phlogopite. The product should be free of asbestos. 238-877-9 Magnesium hydrogen metasilicate Mg3(Si4O10)(OH)2 379,22
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Infrared absorption spectrum X-ray diffraction Solubility
Light, homogeneous, white or almost white powder, greasy to the touch
Characteristic peaks at 3 677, 1 018 and 669 cm-1 Peaks at 9,34/4,66/3,12 Insoluble in water and ethanol
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Purity Loss on drying Acid soluble matter Water soluble matter Acid-soluble iron Arsenic Lead Not more than 0,5 % (105 C, 1 hour) Not more than 6 % Not more than 0,2 % Not detectable Not more than 10 mg/kg Not more than 2 mg/kg
E 554 SODIUM ALUMINIUM SILICATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Content on the anhydrous basis: as SiO2 not less than 66,0 % and not more than 88,0 % as Al2O3 not less than 5,0 % and not more than 15,0 % Description Identification Test for sodium Test for aluminium Test for silicate pH Purity Loss on drying Loss on ignition Sodium Arsenic Lead Mercury Not more than 8,0 % (105 C, 2 hours) Not less than 5,0 % and not more than 11,0 % on the anhydrous basis (1 000 C to constant weight) Not less than 5 % and not more than 8,5 % (as Na2O) on the anhydrous basis Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Passes test Passes test Passes test Between 6,5 and 11,5 (5 % slurry) Fine white amorphous powder or beads Sodium aluminium silicate Sodium silicoaluminate; Sodium aluminosilicate; Aluminium sodium silicate
E 555 POTASSIUM ALUMINIUM SILICATE Synonyms Definition Mica Natural mica consists of mainly potassium aluminium silicate (musco vite)
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Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Purity Loss on drying Antimony Zinc Barium Chromium Copper Nickel Arsenic Mercury Cadmium Lead
310-127-6 Potassium aluminium silicate KAl2[AlSi3O10](OH)2 398 Content not less than 98 % Light grey to white crystalline platelets or powder
Insoluble in water, diluted acids and alkali and organic solvents
Not more than 0,5 % (105 C, 2 hours) Not more than 20 mg/kg Not more than 25 mg/kg Not more than 25 mg/kg Not more than 100 mg/kg Not more than 25 mg/kg Not more than 50 mg/kg Not more than 3 mg/kg Not more than 1 mg/kg Not more than 2 mg/kg Not more than 5 mg/kg
E 556 CALCIUM ALUMINIUM SILICATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Content on the anhydrous basis: as SiO2 not less than 44,0 % and not more than 50,0 % as Al2O3 not less than 3,0 % and not more than 5,0 % as CaO not less than 32,0 % and not more than 38,0 % Description Identification Test for calcium Test for aluminium Test for silicate Passes test Passes test Passes test Fine white, free-flowing powder Calcium aluminium silicate Calcium aluminosilicate; Calcium silicoaluminate; Aluminium calcium silicate
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Purity Loss on drying Loss on ignition Fluoride Arsenic Lead Mercury Not more than 10,0 % (105 C, 2 hours) Not less than 14,0 % and not more than 18,0 on the anhydrous basis (1 000 C, constant weight) Not more than 50 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg
E 559 ALUMINIUM SILICATE (KAOLIN) Synonyms Definition Kaolin, light or heavy Aluminium silicate hydrous (kaolin) is a purified white plastic clay composed of kaolinite, potassium aluminium silicate, feldspar and quartz. Processing should not include calcination. The raw kaolinitic clay used in the production of aluminium silicate shall have a level of dioxin which does not make it injurious to health or unfit for human consumption. The product should be free of asbestos 215-286-4 (kaolinite)
Al2Si2O5(OH)4 (kaolinite) 264 Content not less than 90 % (sum of silica and alumina, after ignition) Silica (SiO2) Alumina (Al2O3) Between 45 % and 55 % Between 30 % and 39 %
Description
Fine, white or greyish white, unctuous powder. Kaolin is made up of loose aggregations of randomly oriented stacks of kaolinite flakes or of individual hexagonal flakes
Identification Test for alumina Test for silicate X-ray diffraction Infrared absorption spectrum Purity Loss on ignition Water soluble matter Acid soluble matter Iron Potassium oxide (K2O) Carbon Arsenic Between 10 and 14 % (1 000 C, constant weight) Not more than 0,3 % Not more than 2 % Not more than 5 % Not more than 5 % Not more than 0,5 % Not more than 3 mg/kg Passes test Passes test Characteristic peaks at 7,18/3,58/2,38/1,78 Peaks at 3 700 and 3 620 cm-1
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Lead Mercury
E 570 FATTY ACIDS Synonyms Definition Linear fatty acids, caprylic acid (C8), capric acid (C10), lauric acid (C12), myristic acid (C14), palmitic acid (C16), stearic acid (C18), oleic acid (C18:1)
Einecs Chemical name Octanoic acid (C8); decanoic acid (C10); dodecanoic acid (C12); tetra decanoic acid (C14); hexadecanoic acid (C16); octadecanoic acid (C18); 9-octadecenoic acid (C18:1)
Chemical formula Molecular weight Assay Description Identification Identification test Purity Residue on ignition Unsaponifiable matter Water content Arsenic Lead Mercury Not more than 0,1 % Not more than 1,5 % Not more than 0,2 % (Karl Fischer method) Not more than 3 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Individual fatty acids can be identified by acid value, iodine value, gas chromatography Not less than 98 % by chromatography A colourless liquid or white solid obtained from oils and fats
E 574 GLUCONIC ACID Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Formation of phenylhydrazine derivative Positive. Compound formed melts between 196 C and 202 C with decomposition Gluconic acid C6H12O7 (gluconic acid) 196,2 Content not less than 49,0 % (as gluconic acid) Colourless to light yellow, clear syrupy liquid D-gluconic acid; Dextronic acid Gluconic acid is an aqueous solution of gluconic acid and gluconodelta-lactone
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Purity Residue on ignition Reducing matter Chloride Sulphate Sulphite Arsenic Lead Mercury Not more than 1,0 % 550 C +/ 20 C till disappearance of organic residues (black spots). Not more than 2,0 % (as D-glucose) Not more than 350 mg/kg Not more than 240 mg/kg Not more than 20 mg/kg Not more than 3 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 575 GLUCONO-DELTA-LACTONE Synonyms Definition Gluconolactone; GDL; D-Gluconic acid delta-lactone; Delta-gluconol actone Glucono-delta-lactone is the cyclic 1,5-intramolecular ester of D-gluconic acid. In aqueous media it is hydrolysed to an equilibrium mixture of D-gluconic acid (55 % - 66 %) and the delta- and gammalactones 202-016-5 D-Glucono-1,5-lactone C6H10O6 178,14 Content not less than 99,0 % on the anhydrous basis Fine, white, nearly odourless, crystalline powder
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Formation of phenylhydrazine derivative of gluconic acid Solubility Purity Water content Reducing substances Lead
Positive. Compound formed melts between 196 C and 202 C with decomposition Freely soluble in water. Sparingly soluble in ethanol
Not more than 0,2 % (Karl Fischer method) Not more than 0,5 % (as D-glucose) Not more than 1 mg/kg
E 576 SODIUM GLUCONATE Synonyms Definition Einecs Chemical name Sodium salt of D-gluconic acid Manufactured by fermentation or chemical catalytic oxidation 208-407-7 Sodium D-gluconate
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Chemical formula Molecular weight Assay Description Identification Test for sodium Test for gluconate Solubility pH Purity Reducing matter Lead
C6H11NaO7 (anhydrous) 218,14 Content not less than 99,0 % White to tan, granular to fine, crystalline powder
Passes test Passes test Very soluble in water. Sparingly soluble in ethanol Between 6,5 and 7,5 (10 % solution)
Not more than 1,0 % (as D-glucose) Not more than 1 mg/kg
E 577 POTASSIUM GLUCONATE Synonyms Definition Einecs Chemical name Chemical formula 206-074-2 Potassium D-gluconate C6H11KO7 (anhydrous) C6H11KO7 H2O (monohydrate) Molecular weight 234,25 (anhydrous) 252,26 (monohydrate) Assay Description Identification Test for potassium Test for gluconate pH Purity Loss on drying Anhydrous: not more than 3,0 % (105 C, 4 hours, vacuum) Monohydrate: not less than 6 % and not more than 7,5 % (105 C, 4 hours, vacuum) Reducing substances Lead Not more than 1,0 % (as D-glucose) Not more than 2 mg/kg Passes test Passes test Between 7,0 and 8,3 (10 % solution) Content not less than 97,0 % and not more than 103,0 % on dried basis Odourless, free flowing white to yellowish white, crystalline powder or granules Potassium salt of D-gluconic acid
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E 578 CALCIUM GLUCONATE Synonyms Definition Einecs Chemical name Chemical formula 206-075-8 Calcium di-D-gluconate C12H22CaO14 (anhydrous) C12H22CaO14 H2O (monohydrate) Molecular weight 430,38 (anhydrous form) 448,39 (monohydrate) Assay anhydrous: Content not less than 98 % and not more than 102 % on the dried basis monohydrate: not less than 98 % and not more than 102 % on the as is basis. Description Identification Test for calcium Test for gluconate Solubility pH Purity Loss on drying Not more than 3,0 % (105 C, 16 hours) (anhydrous) Not more than 2,0 % (105 C, 16 hours) (monohydrate) Reducing substances Lead Not more than 1,0 % (as D-glucose) Not more than 2 mg/kg Passes test Passes test Soluble in water, insoluble in ethanol Between 6,0 and 8,0 (5 % solution) Odourless, white crystalline granules or powder, stable in air Calcium salt of D-gluconic acid
E 579 FERROUS GLUCONATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Test for ferrous ion Formation of phenylhy-drazine derivative of gluconic acid pH Soluble with slight heating in water. Practically insoluble in ethanol Passes test Positive Between 4 and 5,5 (10 % solution) 206-076-3 Ferrous di-D-gluconate dihydrate; Iron(II) di-gluconate dihydrate C12H22FeO142H2O 482,17 Content not less than 95 % on the dried basis Pale greenish-yellow to yellowish-grey powder or granules, which may have a faint odour of burnt sugar
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Purity Loss on drying Oxalic acid Iron (Fe III) Arsenic Lead Mercury Cadmium Reducing substances Not more than 10 % (105 C, 16 hours) Not detectable Not more than 2 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 0,5 % expressed as glucose
E 585 FERROUS LACTATE Synonyms Iron(II) lactate; Iron(II) 2-hydroxy propanoate; Propanoic acid, 2-hydroxy-iron(2 +) salt (2:1) Definition Einecs Chemical name Chemical formula Molecular weight 227-608-0 Ferrous 2-hydroxy propanoate C6H10FeO6 nH2O (n = 2 or 3) 270,02 (dihydrate) 288,03 (trihydrate) Assay Description Identification Solubility Test for ferrous ion Test for lactate pH Purity Loss on drying Iron (Fe III) Arsenic Lead Mercury Cadmium Not more than 18 % (100 C, under vacuum, approximately 700 mm Hg) Not more than 0,6 % Not more than 3 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Soluble in water. Practically insoluble in ethanol Passes test Passes test Between 4 and 6 (2 % solution) Content not less than 96 % on the dried basis Greenish-white crystals or light green powder having a characteristic smell
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E 586 4-HEXYLRESORCINOL Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Nitric acid test Bromine test Purity Melting range Acidity Sulphated ash Resorcinol and other phenols 62 to 67 C Not more than 0,05 % Not more than 0,1 % Shake about 1 g of the sample with 50 ml of water for a few minutes, filter, and to the filtrate add 3 drops of ferric chloride TS. No red or blue colour is produced Not more than 2 mg/kg Not more than 2 mg/kg Not more than 3 mg/kg Freely soluble in ether and acetone; very slightly soluble in water To 1 ml of a saturated solution of the sample, add 1 ml of nitric acid. A light red colour appears To 1 ml of saturated solution of the sample, add 1 ml of bromine TS. A yellow, flocculent precipitate dissolves producing a yellow solution 205-257-4 4-Hexylresorcinol C12H18O2 197,24 Not less than 98 % on the dried basis (4 hours at room temperature) White powder 4-Hexyl-1,3-benzenediol; Hexylresorcinol
Nickel Lead Mercury
E 620 GLUTAMIC ACID Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Solubility 200-293-7 L-Glutamic acid; L-2-amino-pentanedioic acid C5H9NO4 147,13 Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis Sparingly soluble in water; practically insoluble in ethanol or ether L-Glutamic acid; L--Aminoglutaric acid
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Description Identification Test for glutamic acid (by thin layer chromatography) Specific rotation
White crystals or crystalline powder
Passes test []D20 between + 31,5 and + 32,2 (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
pH Purity Loss on drying Sulphated ash Chloride Pyrrolidone carboxylic acid Arsenic Lead
Between 3,0 and 3,5 (saturated solution)
Not more than 0,2 % (80 C, 3 hours) Not more than 0,2 % Not more than 0,2 % Not more than 0,2 % Not more than 2,5 mg/kg Not more than 1 mg/kg
E 621 MONOSODIUM GLUTAMATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Solubility Description Identification Test for sodium Test for glutamic acid (by thin-layer chromatography) Specific rotation Passes test Passes test []D20 between + 24,8 and + 25,3 (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube) pH Purity Loss on drying Chloride Pyrrolidone carboxylic acid Lead Not more than 0,5 % (98 C, 5 hours) Not more than 0,2 % Not more than 0,2 % Not more than 1 mg/kg Between 6,7 and 7,2 (5 % solution) 205-538-1 Monosodium L-glutamate monohydrate C5H8NaNO4 H2O 187,13 Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis Freely soluble in water; practically insoluble in ethanol or ether White, practically odourless crystals or crystalline powder Sodium glutamate; MSG
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E 622 MONOPOTASSIUM GLUTAMATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Solubility Description Identification Test for potassium Test for glutamic acid (by thin-layer chromatography) Specific rotation Passes test Passes test []D20 between + 22,5 and + 24,0 (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube) pH Purity Loss on drying Chloride Pyrrolidone carboxylic acid Lead Not more than 0,2 % (80 C, 5 hours) Not more than 0,2 % Not more than 0,2 % Not more than 1 mg/kg Between 6,7 and 7,3 (2 % solution) 243-094-0 Monopotassium L-glutamate monohydrate C5H8KNO4 H2O 203,24 Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis Freely soluble in water; practically insoluble in ethanol or ether White, practically odourless crystals or crystalline powder Potassium glutamate; MPG
E 623 CALCIUM DIGLUTAMATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Solubility Description Identification Test for calcium Test for glutamic acid (by thin-layer chromatography) Passes test Passes test 242-905-5 Monocalcium di-L-glutamate C10H16CaN2O8 nH2O (n = 0, 1, 2 or 4) 332,32 (anhydrous) Content not less than 98,0 % and not more than 102,0 % on the anhydrous basis Freely soluble in water; practically insoluble in ethanol or ether White, practically odourless crystals or crystalline powder Calcium glutamate
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Specific rotation Purity Water content Chloride Pyrrolidone carboxylic acid Lead
[]D20 between + 27,4 and + 29,2 (for calcium diglutamate with n = 4) (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
Not more than 19,0 % (for calcium diglutamate with n = 4) (Karl Fischer) Not more than 0,2 % Not more than 0,2 % Not more than 1 mg/kg
E 624 MONOAMMONIUM GLUTAMATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Solubility Description Identification Test for ammonium Test for glutamic acid (by thin-layer chromatography) Specific rotation Passes test Passes test []D20 between + 25,4 and + 26,4 (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube) pH Purity Loss on drying Sulphated ash Pyrrolidone carboxylic acid Lead Not more than 0,5 % (50 C, 4 hours) Not more than 0,1 % Not more than 0,2 % Not more than 1 mg/kg Between 6,0 and 7,0 (5 % solution) 231-447-1 Monoammonium L-glutamate monohydrate C5H12N2O4 H2O 182,18 Content not less than 99,0 % and not more 101,0 % on the anhydrous basis Freely soluble in water; practically insoluble in ethanol or ether White, practically odourless crystals or crystalline powder Ammonium glutamate
E 625 MAGNESIUM DIGLUTAMATE Synonyms Definition Einecs Chemical name 242-413-0 Monomagnesium di-L-glutamate tetrahydrate Magnesium glutamate
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Chemical formula Molecular weight Assay Solubility Description Identification Test for magnesium Test for glutamic acid (by thin-layer chromatography) Specific rotation
C10H16MgN2O8 4H2O 388,62 Content not less than 95,0 % and not more than 105,0 % on the anhydrous basis Very soluble in water; practically insoluble in ethanol or ether Odourless, white or off-white crystals or powder
Passes test Passes test []D20 between + 23,8 and + 24,4 (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
pH Purity Water content Chloride Pyrrolidone carboxylic acid Lead
Between 6,4 and 7,5 (10 % solution)
Not more than 24 % (Karl Fischer) Not more than 0,2 % Not more than 0,2 % Not more than 1 mg/kg
E 626 GUANYLIC ACID Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Solubility Description Identification Test for ribose Test for organic phosphate pH Spectrometry Purity Loss on drying Other nucleotides Lead Not more than 1,5 % (120 C, 4 hours) Not detectable by thin-layer chromatography Not more than 1 mg/kg Passes test Passes test Between 1,5 and 2,5 (0,25 % solution) Maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm 201-598-8 Guanosine-5'-monophosphoric acid C10H14N5O8P 363,22 Content not less than 97,0 % on the anhydrous basis Slightly soluble in water, practically insoluble in ethanol Odourless, colourless or white crystals or white crystalline powder 5'-Guanylic acid
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E 627 DISODIUM GUANYLATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Solubility Description Identification Test for ribose Test for organic phosphate Test for sodium pH Spectrometry Purity Loss on drying Other nucleotides Lead Not more than 25 % (120 C, 4 hours) Not detectable by thin-layer chromatography Not more than 1 mg/kg Passes test Passes test Passes test Between 7,0 and 8,5 (5 % solution) maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm 221-849-5 Disodium guanosine-5'-monophosphate C10H12N5Na2O8P nH2O (n = ca. 7) 407,19 (anhydrous) Content not less than 97,0 % on the anhydrous basis Soluble in water, sparingly soluble in ethanol, practically insoluble in ether Odourless, colourless or white crystals or white crystalline powder Sodium guanylate; Sodium 5'-guanylate
E 628 DIPOTASSIUM GUANYLATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Solubility Description Identification Test for ribose Test for organic phosphate Test for potassium pH Spectrometry Passes test Passes test Passes test Between 7,0 and 8,5 (5 % solution) Maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm 226-914-1 Dipotassium guanosine-5'-monophosphate C10H12K2N5O8P 439,40 Content not less than 97,0 % on the anhydrous basis Freely soluble in water, practically insoluble in ethanol Odourless, colourless or white crystals or white crystalline powder Potassium guanylate; Potassium 5'-guanylate
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Purity Loss on drying Other nucleotides Lead Not more than 5 % (120 C, 4 hours) Not detectable by thin-layer chromatography Not more than 1 mg/kg
E 629 CALCIUM GUANYLATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Solubility Description Identification Test for ribose Test for organic phosphate Test for calcium pH Spectrometry Purity Loss on drying Other nucleotides Lead Not more than 23,0 % (120 C, 4 hours) Not detectable by thin-layer chromatography Not more than 1 mg/kg Passes test Passes test Passes test Between 7,0 and 8,0 (0,05 % solution) Maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm Calcium guanosine-5'-monophosphate C10H12CaN5O8P nH2O 401,20 (anhydrous) Content not less than 97,0 % on the anhydrous basis Sparingly soluble in water Odourless, white or off-white crystals or powder Calcium 5'-guanylate
E 630 INOSINIC ACID Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Solubility Description 205-045-1 Inosine-5'-monophosphoric acid C10H13N4O8P 348,21 Content not less than 97,0 % on the anhydrous basis Freely soluble in water, slightly soluble in ethanol Odourless, colourless or white crystals or powder 5'-Inosinic acid
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Identification Test for ribose Test for organic phosphate pH Spectrometry Purity Loss on drying Other nucleotides Lead Not more than 3,0 % (120 C, 4 hours) Not detectable by thin-layer chromatography Not more than 1 mg/kg Passes test Passes test Between 1,0 and 2,0 (5 % solution) Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
E 631 DISODIUM INOSINATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Solubility Description Identification Test for ribose Test for organic phosphate Test for sodium pH Spectrometry Purity Water content Other nucleotides Lead Not more than 28,5 % (Karl Fischer) Not detectable by thin-layer chromatography Not more than 1 mg/kg Passes test Passes test Passes test Between 7,0 and 8,5 Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm 225-146-4 Disodium inosine-5'-monophosphate C10H11N4Na2O8P H2O 392,17 (anhydrous) Content not less than 97,0 % on the anhydrous basis Soluble in water, sparingly soluble in ethanol, practically insoluble in ether Odourless, colourless or white crystals or powder Sodium inosinate; Sodium 5'-inosinate
E 632 DIPOTASSIUM INOSINATE Synonyms Definition Einecs Chemical name 243-652-3 Dipotassium inosine-5'-monophosphate Potassium inosinate; Potassium 5'-inosinate
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Chemical formula Molecular weight Assay Solubility Description Identification Test for ribose Test for organic phosphate Test for potassium pH Spectrometry Purity Water content Other nucleotides Lead
C10H11K2N4O8P 424,39 Content not less than 97,0 % on the anhydrous basis Freely soluble in water; practically insoluble in ethanol Odourless, colourless or white crystals or powder
Passes test Passes test Passes test Between 7,0 and 8,5 (5 % solution) Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
Not more than 10,0 % (Karl Fischer) Not detectable by thin-layer chromatography Not more than 1 mg/kg
E 633 CALCIUM INOSINATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Solubility Description Identification Test for ribose Test for organic phosphate Test for calcium pH Spectrometry Purity Water content Other nucleotides Lead Not more than 23,0 % (Karl Fischer) Not detectable by thin-layer chromatography Not more than 1 mg/kg Passes test Passes test Passes test Between 7,0 and 8,0 (0,05 % solution) Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm Calcium inosine-5'-monophosphate C10H11CaN4O8P nH2O 386,19 (anhydrous) Content not less than 97,0 % on the anhydrous basis Sparingly soluble in water Odourless, colourless or white crystals or powder Calcium 5'-inosinate
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E 634 CALCIUM 5'-RIBONUCLEOTIDE Synonyms Definition Einecs Chemical name Chemical formula Calcium 5-ribonucleotide is essentially a mixture of calcium inosine5-monophosphate and calcium guanosine-5-monophosphate C10H11N4CaO8P nH2O C10H12N5CaO8P nH2O Molecular weight Assay Content of both major components not less than 97,0 %, and of each component not less than 47,0 % and not more than 53 %, in every case on the anhydrous basis Sparingly soluble in water Odourless, white or nearly white crystals or powder
Solubility Description Identification Test for ribose Test for organic phosphate Test for calcium pH Purity Water content Other nucleotides Lead
Passes test Passes test Passes test Between 7,0 and 8,0 (0,05 % solution)
Not more than 23,0 % (Karl Fischer) Not detectable by thin-layer chromatography Not more than 1 mg/kg
E 635 DISODIUM 5'-RIBONUCLEOTIDE Synonyms Definition Einecs Chemical name Chemical formula Disodium 5'-ribonucleotide is essentially a mixture of disodium inosine-5'-monophosphate and disodium guanosine-5'-monophosphate C10H11N4O8P nH2O C10H12N5Na2O8P nH2O Molecular weight Assay Content of both major components not less than 97,0 %, and of each component not less than 47,0 % and not more than 53 %, in every case on the anhydrous basis Soluble in water, sparingly soluble in ethanol practically insoluble in ether Odourless, white or nearly white crystals or powder Sodium 5'-ribonucleotide
Solubility Description
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Identification Test for ribose Test for organic phosphate Test for sodium pH Purity Water content Other nucleotides Lead Not more than 26,0 % (Karl Fischer) Not detectable by thin-layer chromatography Not more than 1 mg/kg Passes test Passes test Passes test Between 7,0 and 8,5 (5 % solution)
E 640 GLYCINE AND ITS SODIUM SALT (i) GLYCINE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for amino acid Purity Loss on drying Residue on ignition Arsenic Lead Mercury Not more than 0,2 % (105 C, 3 hours) Not more than 0,1 % Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Passes test 200-272-2 Aminoacetic acid C2H5NO2 75,07 Content not less than 98,5 % on the anhydrous basis White crystals or crystalline powder Aminoacetic acid; Glycocoll
(ii) SODIUM GLYCINATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 227-842-3 Sodium glycinate C2H5NO2 Na 98 Content not less than 98,5 % on the anhydrous basis
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Description Identification Test for amino acid Test for sodium Purity Loss on drying Residue on ignition Arsenic Lead Mercury
White crystals or crystalline powder
Not more than 0,2 % (105 C, 3 hours) Not more than 0,1 % Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg
E 650 ZINC ACETATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for acetate Test for zinc pH Purity Water insoluble matter Chlorides Sulphates Alkalines and alkaline earths Organic volatile impurities Iron Arsenic Lead Cadmium Not more than 0,005 % Not more than 50 mg/kg Not more than 100 mg/kg Not more than 0,2 % Passes test Not more than 50 mg/kg Not more than 3 mg/kg Not more than 20 mg/kg Not more than 5 mg/kg Passes test Passes test Between 6,0 and 8,0 (5 % solution) Zinc acetate dihydrate C4H6O4 Zn 2H2O 219,51 Content not less than 98 % and not more than 102 % of C4H6O4 Zn 2H2O Colourless crystals or fine, off-white powder Acetic acid, zinc salt, dihydrate
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E 900 DIMETHYL POLYSILOXANE Synonyms Definition Polydimethyl siloxane; Silicone fluid; Silicone oil; Dimethyl silicone Dimethylpolysiloxane is a mixture of fully methylated linear siloxane polymers containing repeating units of the formula (CH3)2 SiO and stabilised with trimethylsiloxy end-blocking units of the formula (CH3)3 SiO
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Specific gravity (25 C/25 C) Refractive index Infrared absorption spectrum Between 0,964 and 0,977 [n]D25 between 1,400 and 1,405 The infrared absorption spectrum of a liquid film of the sample between two sodium chloride plates exhibits relative maxima at the same wavelengths as those of a similar preparation of Dimethylpoly siloxane Reference Standard Content of total silicon not less than 37,3 % and not more than 38,5 % Clear, colourless, viscous liquid Siloxanes and silicones, di-methyl (CH3)3-Si-[O-Si(CH3)2]n-O-Si(CH3)3
Purity Loss on drying Viscosity Arsenic Lead Mercury Not more than 0,5 % (150 C, 4h) Not less than 1,00 10 4 m2s 1 at 25 C Not more than 3 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 901 BEESWAX, WHITE AND YELLOW Synonyms Definition White wax; Yellow wax Yellow bees wax is the wax obtained by melting the walls of the honeycomb made by the honey bee, Apis mellifera L., with hot water and removing foreign matter White beeswax is obtained by bleaching yellow beeswax Einecs Chemical name Chemical formula Molecular weight Assay Description Yellowish white (white form) or yellowish to greyish brown (yellow form) pieces or plates with a fine-grained and non-crystalline fracture, having an agreeable, honey-like odour 232-383-7
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Identification Melting range Specific gravity Solubility Purity Acid value Saponification value Peroxide value Glycerol and other polyols Ceresin, paraffins and certain other waxes Not less than 17 and not more than 24 87-104 Not more than 5 Not more than 0,5 % (as glycerol) Transfer 3,0 g of the sample to a 100 ml round-bottomed flask, add 30 ml of a 4% w/v solution of potassium hydroxide in aldehyde-free ethanol and boil gently under a reflux condenser for 2 h. Remove the condenser and immediately insert a thermometer. Place the flask in water at 80 C and allow to cool, swirling the solution continuously. No precipitate is formed before the temperature reaches 65 C, although the solution may be opalescent. Boil 1 g of the sample for 30 min with 35 ml of a 1 in 7 solution of sodium hydroxide, maintaining the volume by the occasional addition of water, and cool the mixture. The wax separates and the liquid remains clear. Filter the cold mixture and acidify the filtrate with hydro chloric acid. No precipitate is formed. Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Between 62 C and 65 C About 0,96 Insoluble in water, sparingly soluble in alcohol, very soluble in chloroform and ether
Fats, Japan wax, rosin and soaps
E 902 CANDELILLA WAX Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Specific gravity Melting range Solubility About 0,98 Between 68,5 C and 72,5 C Insoluble in water, soluble in chloroform and toluene Hard, yellowish brown, opaque to translucent wax Candelilla wax is a purified wax obtained from the leaves of the candelilla plant, Euphorbia antisyphilitica 232-347-0
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Purity Acid value Saponification value Arsenic Lead Mercury Not less than 12 and not more than 22 Not less than 43 and not more than 65 Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 903 CARNAUBA WAX Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Specific gravity Melting range Solubility Purity Sulphated ash Acid value Ester value Unsaponifiable matter Arsenic Lead Mercury Not more than 0,25 % Not less than 2 and not more than 7 Not less than 71 and not more than 88 Not less than 50 % and not more than 55 % Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg About 0,997 Between 82 C and 86 C Insoluble in water, partly soluble in boiling ethanol, soluble in chloroform and diethyl ether Light brown to pale yellow powder or flakes or hard and brittle solid with a resinous fracture Carnauba wax is a purified wax obtained from the leaf buds and leaves of the Brazilian Mart wax palm, Copernicia cerifera 232-399-4
E 904 SHELLAC Synonyms Definition Einecs Chemical name Bleached shellac; White shellac Shellac is the purified and bleached lac, the resinous secretion of the insect Laccifer (Tachardia) lacca Kerr (Fam. Coccidae) 232-549-9
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Chemical formula Molecular weight Assay Description Bleached shellac off-white, amorphous, granular resin Wax-free bleached shellac light yellow, amorphous, granular resin Identification Solubility Acid value Purity Loss on drying Rosin Wax Not more than 6,0 % (40 C, over silica gel, 15 hours) Absent Bleached shellac: not more than 5,5 % Wax-free bleached shellac: not more than 0,2 % Lead Not more than 2 mg/kg Insoluble in water; freely (though very slowly) soluble in alcohol; slightly soluble in acetone Between 60 and 89
E 905 MICROCRYSTALLINE WAX Synonyms Definition Description Identification Solubility Refractive index Insoluble in water, very slightly soluble in ethanol [n]D100 1,434-1,448 Alternative [n]D1201,426-1,440 Purity Molecular weight Viscosity Average not less than 500 Not less than 1,1 10 5 m2s 1at 100 C Alternative: Not less than 0,8 10 5 m2s 1at 120 C, if solid at 100 C Residue on ignition Carbon number at 5 % distillation point Colour Sulphur Arsenic Lead Polycyclic aromatic compounds Not more than 0,1 % Not more than 5 % of molecules with carbon number less than 25 Passes test Not more than 0,4 wt % Not more than 3 mg/kg Not more than 3 mg/kg Benzo(a)pyrene no more than 50 g/kg Petroleum wax; Hydrocarbon wax; Fischer-Tropsch wax; Synthetic wax; Synthetic paraffin Refined mixtures of solid, saturated hydrocarbons, obtained from petroleum or synthetic feedstocks White to amber, odourless wax
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E 907 HYDROGENATED POLY-1-DECENE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay C10nH20n+2 where n = 3-6 560 (average) Not less than 98,5 % of hydrogenated poly-1-decene, having the following oligomer distribution: C30: 13-37 % C40: 35-70 % C50: 9-25 % C60: 1-7 % Description Identification Solubility Burning Viscosity Purity Compounds with carbon number less than 30 Readily carbonisable substances Not more than 1,5 % After 10 minutes shaking in a boiling water bath, a tube of sulphuric acid with a 5 g sample of hydrogenated poly-1-decene is not darker than a very slight straw colour Not more than 1 mg/kg Not more than 1 mg/kg Insoluble in water; slightly soluble in ethanol; soluble in toluene Burns with a bright flame and a paraffin-like characteristic smell Between 5,7 10 6 and 6,1 10 6 m2s 1 at 100 C Hydrogenated polydec-1-ene; Hydrogenated poly-alpha-olefin
Nickel Lead
E 912 MONTAN ACID ESTERS Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Density Drop point Between 0,98 and 1,05 (20 C) Greater than 77 C Almost white to yellowish flakes, powder, granules or pellets Montan acid esters Montan acids and/or esters with ethylene glycol and/or 1,3-butanediol and/or glycerol
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Purity Acid value Glycerol Other polyols Other wax types Arsenic Chromium Lead Not more than 40 Not more than 1 % (by gas chromatography) Not more than 1 % (by gas chromatography) Not detectable (by differential scanning calorimetry and/or infrared spectroscopy) Not more than 2 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg
E 914 OXIDISED POLYETHYLENE WAX Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Density Drop point Purity Acid value Viscosity Other wax types Oxygen Chromium Lead Not more than 70 Not less than 8,1 10 5 m2s 1 at 120 C Not detectable (by differential scanning calorimetry and/or infrared spectroscopy) Not more than 9,5 % Not more than 5 mg/kg Not more than 2 mg/kg Between 0,92 and 1,05 (20 C) Greater than 95 C Almost white flakes, powder, granules or pellets Oxidised polyethylene Polar reaction products from mild oxidation of polyethylene
E 920 L-CYSTEINE Synonyms Definition Einecs Chemical name Chemical formula C3H7NO2S HCl nH2O (where n = 0 or 1) L-cysteine hydrochloride or hydrochloride monohydrate. Human hair may not be used as a source for this substance 200-157-7 (anhydrous)
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Molecular weight Assay Description Identification Solubility Melting range Specific rotation
157,62 (anhydrous) Content not less than 98,0 % and not more than 101,5 % on the anhydrous basis White powder or colourless crystals
Freely soluble in water and in ethanol Anhydrous form melts at about 175 C []D20: between + 5,0 and + 8,0 or []D25: between + 4,9 and 7,9
Purity Loss on drying Between 8,0 % and 12,0 % Not more than 2,0 % (anhydrous form) Residue on ignition Ammonium-ion Arsenic Lead Not more than 0,1 % Not more than 200 mg/kg Not more than 1,5 mg/kg Not more than 5 mg/kg
E 927b CARBAMIDE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Very soluble in water Soluble in ethanol Precipitation with nitric acid Colour reaction Melting range Purity Loss on drying Sulphated ash Ethanol-insoluble matter Alkalinity Ammonium-ion Not more than 1,0 % (105 C, 1 hour) Not more than 0,1 % Not more than 0,04 % Passes test Not more than 500 mg/kg To pass the test a white, crystalline precipitate is formed To pass the test a reddish-violet colour is produced 132 C to 135 C CH4N2O 60,06 Content not less than 99,0 % on the anhydrous basis Colourless to white, prismatic, crystalline powder or small, white pellets 200-315-5 Urea
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Biuret Arsenic Lead
Not more than 0,1 % Not more than 3 mg/kg Not more than 2 mg/kg
E 938 ARGON Synonyms Definition Einecs Chemical name Chemical formula Atomic weight Assay Description Identification Purity Water content Methane and other hydrocarbons Not more than 0,05 % Not more than 100 l/l (calculated as methane) 231-147-0 Argon Ar 40 Not less than 99 % Colourless, odourless, non-flammable gas
E 939 HELIUM Synonyms Definition Einecs Chemical name Chemical formula Atomic weight Assay Description Identification Purity Water content Methane and other hydrocarbons Not more than 0,05 % Not more than 100 l/l (calculated as methane) 231-168-5 Helium He 4 Not less than 99 % Colourless, odourless, non-flammable gas
E 941 NITROGEN Synonyms Definition Einecs Chemical name 231-783-9 Nitrogen
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Chemical formula Molecular weight Assay Description Identification Purity Water content Carbon monoxide Methane and other hydrocarbons Nitrogen dioxide and nitrogen oxide Oxygen
N2 28 Not less than 99 % Colourless, odourless, non-flammable gas
Not more than 0,05 % Not more than 10 l/l Not more than 100 l/l (calculated as methane) Not more than 10 l/l Not more than 1 %
E 942 NITROUS OXIDE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Purity Water content Carbon monoxide Nitrogen dioxide and nitrogen oxide Not more than 0,05 % Not more than 30 l/l Not more than 10 l/l 233-032-0 Nitrous oxide N2O 44 Not less than 99 % Colourless, non-flammable gas, sweetish odour
E 943a BUTANE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Butane CH3CH2CH2CH3 58,12 Content not less than 96 % Colourless gas or liquid with mild, characteristic odour n-Butane
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Identification Vapour pressure Purity Methane Ethane Propane Isobutane 1,3-butadiene Moisture Not more than 0,15 % v/v Not more than 0,5 % v/v Not more than 1,5 % v/v Not more than 3,0 % v/v Not more than 0,1 % v/v Not more than 0,005 % 108,935 kPa at 20 C
E 943b ISOBUTANE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Vapour pressure Purity Methane Ethane Propane n-Butane 1,3-butadiene Moisture Not more than 0,15 % v/v Not more than 0,5 % v/v Not more than 2,0 % v/v Not more than 4,0 % v/v Not more than 0,1 % v/v Not more than 0,005 % 205,465 kPa at 20 C 2-methyl propane (CH3)2CH CH3 58,12 Content not less than 94 % Colourless gas or liquid with mild, characteristic odour 2-Methyl propane
E 944 PROPANE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Propane CH3CH2CH3 44,09 Content not less than 95 %
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Description Identification Vapour pressure Purity Methane Ethane Isobutane n-Butane 1,3-butadiene Moisture
Colourless gas or liquid with mild, characteristic odour
732,910 kPa at 20 C
Not more than 0,15 % v/v Not more than 1,5 % v/v Not more than 2,0 % v/v Not more than 1,0 % v/v Not more than 0,1 % v/v Not more than 0,005 %
E 948 OXYGEN Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Purity Water content Methane and other hydrocarbons Not more than 0,05 % Not more than 100 l/l (calculated as methane) 231-956-9 Oxygen O2 32 Not less than 99 % Colourless, odourless, non-flammable gas
E 949 HYDROGEN Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification 215-605-7 Hydrogen H2 2 Content not less than 99,9 % Colourless, odourless, highly flammable gas
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Purity Water content Oxygen Nitrogen Not more than 0,005 % v/v Not more than 0,001 % v/v Not more than 0,07 % v/v
E 950 ACESULFAME K Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Ultraviolet absorption Test for potassium Precipitation test Very soluble in water, very slightly soluble in ethanol Maximum 227 2 nm for a solution of 10 mg in 1 000 ml of water Passes test (test the residue obtained by igniting 2 g of the sample) Add a few drops of a 10 % solution of sodium cobaltnitrite to a solution of 0,2 g of the sample in 2 ml of acetic acid and 2 ml of water. A yellow precipitate is produced 259-715-3 6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt C4H4KNO4S 201,24 Content not less than 99 % of C4H4KNO4S on the anhydrous basis Odourless, white, crystalline powder. Approximately 200 times as sweet as sucrose Acesulfame potassium; Potassium salt of 3,4-dihydro-6-methyl-1,2,3oxathiazin-4-one-2,2-dioxide
Purity Loss on drying Organic impurities Fluoride Lead Mercury Not more than 1 % (105 C, 2 hours) Passes test for 20 mg/kg of UV active components Not more than 3 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg
E 951 ASPARTAME Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 245-261-3 N-L--Aspartyl-L-phenylalanine-1-methyl ester, 3-amino-N-(-carbome thoxy-phenethyl)-succinamic acid-N-methyl ester C14H18N2O5 294,31 Not less than 98 % and not more than 102 % of C14H18N2O5 on the anhydrous basis Aspartyl phenylalanine methyl ester
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Description Identification Solubility pH Specific rotation
White, odourless, crystalline powder having a sweet taste. Approxi mately 200 times as sweet as sucrose
Slightly soluble in water and in ethanol Between 4,5 and 6,0 (1 in 125 solution) []D20: + 14,5 to + 16,5 Determine in a 4 in 100/15 N formic acid solution within 30 minutes after preparation of the sample solution
Purity Loss on drying Sulphated ash Transmittance Not more than 4,5 % (105 C, 4 hours) Not more than 0,2 % (expressed on dry weight basis) The transmittance of a 1 % solution in 2N hydrochloric acid, determined in a 1-cm cell at 430 nm with a suitable spectrophoto meter, using 2N hydrochloric acid as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022 Not more than 3 mg/kg (expressed on dry weight basis) Not more than 1 mg/kg (expressed on dry weight basis) Not more than 1,5 % (expressed on dry weight basis)
Arsenic Lead 5-Benzyl-3,6-dioxo-2-piperazineacetic acid
E 952 CYCLAMIC ACID AND ITS Na AND Ca SALTS (i) CYCLAMIC ACID Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 202-898-1 Cyclohexanesulphamic acid; cyclohexylaminosulphonic acid C6H13NO3S 179,24 Cyclohexylsulphamic acid contains not less than 98 % and not more than the equivalent of 102 % of C6H13NO3S, calculated on the anhydrous basis A practically colourless, white crystalline powder. Approximately 40 times as sweet as sucrose Cyclohexylsulphamic acid; Cyclamate
Description Identification Solubility Precipitation test
Soluble in water and in ethanol Acidify a 2 % solution with hydrochloric acid, add 1 ml of an approxi mately molar solution of barium chloride in water and filter if any haze or precipitate forms. To the clear solution add 1 ml of a 10 % solution of sodium nitrite. A white precipitate forms.
Purity Loss on drying Selenium Lead Not more than 1 % (105 C, 1 hour) Not more than 30 mg/kg (expressed as selenium on dry weight basis) Not more than 1 mg/kg (expressed on dry weight basis)
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Arsenic Cyclohexylamine Dicyclohexylamine Aniline
Not more than 3 mg/kg (expressed on dry weight basis) Not more than 10 mg/kg (expressed on dry weight basis) Not more than 1 mg/kg (expressed on dry weight basis) Not more than 1 mg/kg (expressed on dry weight basis)
(ii) SODIUM CYCLAMATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight 205-348-9 Sodium cyclohexanesulphamate, sodium cyclohexylsulphamate C6H12NNaO3S and the dihydrate form C6H12NNaO3S2H2O 201,22 calculated on the anhydrous form 237,22 calculated on the hydrated form Assay Not less than 98 % and not more than 102 % on the dried basis Dihydrate form: not less than 84 % on the dried basis Description Identification Solubility Purity Loss on drying Not more than 1 % (105 C, 1 hour) Not more than 15,2 % (105 C, 2 hours) for the dihydrate form Selenium Arsenic Lead Cyclohexylamine Dicyclohexylamine Aniline Not more than 30 mg/kg (expressed as selenium on dry weight basis) Not more than 3 mg/kg (expressed on dry weight basis) Not more than 1 mg/kg (expressed on dry weight basis) Not more than 10 mg/kg (expressed on dry weight basis) Not more than 1 mg/kg (expressed on dry weight basis) Not more than 1 mg/kg (expressed on dry weight basis) Soluble in water, practically insoluble in ethanol White, odourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose Cyclamate; Sodium salt of cyclamic acid
(iii) CALCIUM CYCLAMATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay 205-349-4 Calcium cyclohexanesulphamate, calcium cyclohexylsulphamate C12H24CaN2O6S2 2H2O 432,57 Not less than 98 % and not more than 101 % on the dried basis Cyclamate; Calcium salt of cyclamic acid
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Description Identification Solubility Purity Loss on drying
White, colourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose
Soluble in water, sparingly soluble in ethanol
Not more than 1 % (105 C, 1 hour) Not more than 8,5 % (140 C, 4 hours) for the dihydrate form
Selenium Arsenic Lead Cyclohexylamine Dicyclohexylamine Aniline
Not more than 30 mg/kg (expressed as selenium on dry weight basis) Not more than 3 mg/kg (expressed on dry weight basis) Not more than 1 mg/kg (expressed on dry weight basis) Not more than 10 mg/kg (expressed on dry weight basis) Not more than 1 mg/kg (expressed on dry weight basis) Not more than 1 mg/kg (expressed on dry weight basis)
E 953 ISOMALT Synonyms Definition Einecs Chemical name Isomalt is a mixture of hydrogenated mono- and disaccharides whose principal components are the disaccharides: 6-O--D-Glucopyranosyl-D-sorbitol (1,6-GPS) and 1-O--D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM) Chemical formula 6-O--D-Glucopyranosyl-D-sorbitol: C12H24O11 1-O--D-Glucopyranosyl-D-mannitol dihydrate: C12H24O11.2H2O Molecular weight 6-O--D-Glucopyranosyl-D-sorbitol: 344,3 1-O--D-Glucopyranosyl-D-mannitol dihydrate: 380,3 Assay Content not less than 98 % of hydrogenated mono- and disaccharides and not less than 86 % of the mixture of 6-O--D-Glucopyranosyl-Dsorbitol and 1-O--D-Glucopyranosyl-D-mannitol dihydrate determined on the anhydrous basis. Odourless, white, slightly hygroscopic, crystalline mass. Hydrogenated isomaltulose. Manufactured by enzymatic conversion of sucrose with nonviable cells of Protaminobacter rubrum followed by catalytic hydrogenation
Description Identification Solubility HPLC test
Soluble in water, very slightly soluble in ethanol. Comparison with an appropriate reference standard of Isomalt shows that the 2 principal peaks in the chromatogram of the test solution are similar in retention time to the 2 principal peaks in the chromatogram obtained with the reference solution.
Purity Water content Sulphated ash Not more than 7 % (Karl Fischer Method) Not more than 0,05 % (expressed on dry weight basis)
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D-Mannitol D-Sorbitol Reducing sugars Nickel Arsenic Lead
Not more than 3 % Not more than 6 % Not more than 0,3 % (expressed as glucose on dry weight basis) Not more than 2 mg/kg (expressed on dry weight basis) Not more than 3 mg/kg (expressed on dry weight basis) Not more than 1 mg/kg (expressed on dry weight basis)
E 954 SACCHARIN AND ITS Na. K AND Ca SALTS (i) SACCHARIN Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description 201-321-0 3-Oxo-2,3dihydrobenzo(d)isothiazol-1,1-dioxide C7H5NO3S 183,18 Not less than 99 % and not more than 101 % of C7H5NO3S on the anhydrous basis White crystals or a white crystalline powder, odourless or with a faint, aromatic odour. Approximately between 300 and 500 times as sweet as sucrose
Identification Solubility Purity Loss on drying Melting range Sulphated ash Benzoic and salicylic acid Not more than 1 % (105 C, 2 hours) 226 to 230 C Not more than 0,2 % (expressed on dry weight basis) To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears Not more than 10 mg/kg (expressed on dry weight basis) Not more than 10 mg/kg (expressed on dry weight basis) Not more than 25 mg/kg (expressed on dry weight basis) Absent Not more than 3 mg/kg (expressed on dry weight basis) Not more than 30 mg/kg (expressed on dry weight basis) Not more than 1 mg/kg (expressed on dry weight basis) Slightly soluble in water, soluble in basic solutions, sparingly soluble in ethanol
o-Toluenesulphonamide p-Toluenesulphonamide Benzoic acid p-sulphonamide Readily carbonisable substances Arsenic Selenium Lead
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(ii) SODIUM SACCHARIN Synonyms Definition Einecs Chemical name 204-886-1 Sodium o-benzosulphimide; sodium salt of 2,3-dihydro-3-oxobenziso sulphonazole; oxobenzisosulphonazole; 1,2-benzisothiazolin-3-one-1, 1-dioxide sodium salt dihydrate C7H4NNaO3S2H2O 241,19 Not less than 99 % and not more than 101 % of C7H4NNaO3S on the anhydrous basis White crystals or a white crystalline efflorescent powder, odourless or with a faint odour. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions Saccharin; Sodium salt of saccharin
Identification Solubility Purity Loss on drying Benzoic and salicylic acid Not more than 15 % (120 C, 4 hours) To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears Not more than 10 mg/kg (expressed on dry weight basis) Not more than 10 mg/kg (expressed on dry weight basis) Not more than 25 mg/kg (expressed on dry weight basis) Absent Not more than 3 mg/kg (expressed on dry weight basis) Not more than 30 mg/kg (expressed on dry weight basis) Not more than 1 mg/kg (expressed on dry weight basis) Freely soluble in water, sparingly soluble in ethanol
(iii) CALCIUM SACCHARIN Synonyms Definition Chemical name Calcium o-benzosulphimide; calcium salt of 2,3-dihydro-3-oxobenziso sulphonazole; 1,2-benzisothiazolin-3-one-1,1-dioxide calcium salt hydrate (2:7) 229-349-9 C14H8CaN2O6S23H2O 467,48 Not less than 95 % of C14H8CaN2O6S2 on the anhydrous basis White crystals or a white crystalline powder, odourless or with a faint odour. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions Saccharin; Calcium salt of saccharin
Einecs Chemical formula Molecular weight Assay Description
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Identification Solubility Purity Loss on drying Benzoic and salicylic acid Not more than 13,5 % (120 C, 4 hours) To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears Not more than 10 mg/kg expressed (on dry weight basis) Not more than 10 mg/kg expressed (on dry weight basis) Not more than 25 mg/kg expressed (on dry weight basis) Absent Not more than 3 mg/kg (expressed on dry weight basis) Not more than 30 mg/kg (expressed on dry weight basis) Not more than 1 mg/kg (expressed on dry weight basis) Freely soluble in water, soluble in ethanol
(iv) POTASSIUM SACCHARIN Synonyms Definition Einecs Chemical name Potassium o-benzosulphimide; potassium salt of 2,3-dihydro-3-oxoben zisosulphonazole; potassium salt of 1,2-benzisothiazolin-3-one-1,1dioxide monohydrate C7H4KNO3SH2O 239,77 Not less than 99 % and not more than 101 % of C7H4KNO3S on the anhydrous basis White crystals or a white crystalline powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose Saccharin; Potassium salt of saccharin
Identification Solubility Purity Loss on drying Benzoic and salicylic acid Not more than 8 % (120 C, 4 hours) To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears Not more than 10 mg/kg (expressed on dry weight basis) Not more than 10 mg/kg (expressed on dry weight basis) Not more than 25 mg/kg (expressed on dry weight basis) Absent Freely soluble in water, sparingly soluble in ethanol
o-Toluenesulphonamide p-Toluenesulphonamide Benzoic acid p-sulphonamide Readily carbonisable substances
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Arsenic Selenium Lead
Not more than 3 mg/kg (expressed on dry weight basis) Not more than 30 mg/kg (expressed on dry weight basis) Not more than 1 mg/kg (expressed on dry weight basis)
E 955 SUCRALOSE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Freely soluble in water, methanol and ethanol Slightly soluble in ethyl acetate Infrared absorption spectrum The infrared spectrum of a potassium bromide dispersion of the sample exhibits relative maxima at similar wave numbers as those shown in the reference spectrum obtained using a sucralose reference standard. The main spot in the test solution has the same Rf value as that of the main spot of standard solution A referred to in the test for other chlorinated disaccharides. This standard solution is obtained by dissolving 1,0g of sucralose reference standard in 10 ml of methanol. []D20 + 84,0 to + 87,5 calculated on the anhydrous basis (10 % w/v solution) 259-952-2 1,6-Dichloro-1,6-dideoxy--D-fructofuranosyl-4-chloro-4-deoxy--Dgalactopyranoside C12H19Cl3O8 397,64 Content not less than 98 % and not more than 102 % C12H19Cl3O8 calculated on an anhydrous basis. White to off-white, practically odourless, crystalline powder. 4,1,6-Trichlorogalactosucrose
Thin layer chromatography
Specific rotation Purity Water content Sulphated ash Other chlorinated disaccharides Chlorinated monosaccharides Triphenylphosphine oxide Methanol Lead
Not more than 2,0 % (Karl Fischer method) Not more than 0,7 % Not more than 0,5 % Not more than 0,1 % Not more than 150 mg/kg Not more than 0,1 % Not more than 1 mg/kg
E 957 THAUMATIN Synonyms Definition Einecs 258-822-2
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Chemical name
Thaumatin is obtained by aqueous extraction (pH 2,5 to 4) of the arils of the fruit of strains of Thaumatococcus daniellii (Benth) and consists essentially of the proteins thaumatin I and thaumatin II together with minor amounts of plant constituents derived from the source material Polypeptide of 207 amino acids Thaumatin I 22209 Thaumatin II 22293
Chemical formula Molecular weight
Assay Description Identification Solubility Purity Loss on drying Carbohydrates Sulphated ash Aluminium Arsenic Lead Microbiological criteria Total aerobic microbial count Escherichia coli
Not less than 15,1 % nitrogen on the dried basis equivalent to not less than 93 % proteins (N 6,2) Odourless, cream-coloured powder. Approximately 2 000 to 3 000 times as sweet as sucrose
Very soluble in water, insoluble in acetone
Not more than 9 % (105 C to constant weight) Not more than 3 % (expressed on dry weight basis) Not more than 2 % (expressed on dry weight basis) Not more than 100 mg/kg (expressed on dry weight basis) Not more than 3 mg/kg (expressed on dry weight basis) Not more than 3 mg/kg (expressed on dry weight basis)
Not more than 1 000 colonies per gram Absent in 1 g
E 959 NEOHESPERIDINE DIHYDROCHALCONE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Ultraviolet absorption maximum Freely soluble in hot water, very slightly soluble in cold water, prac tically insoluble in ether and benzene 282 to 283 nm for a solution of 2 mg in 100 ml methanol Neohesperidin dihydrochalcone; NHDC; Hesperetin dihydrochalcone4--neohesperidoside; Neohesperidin DC It is obtained by catalytic hydrogenation of neohesperidin 243-978-6 2-O--L-rhamnopyranosyl-4--D-glucopyranosyl hesperetin dihydro chalcone. C28H36O15 612,6 Content not less than 96 % on the dried basis Off-white, odourless, crystalline powder. Approximately between 1 000 and 1 800 times as sweet as sucrose
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Neu's test
Dissolve about 10 mg of neohesperidine DC in 1 ml methanol, add 1 ml of a 1 % 2-aminoethyl diphenyl borate methanolic solution. A bright yellow colour is produced
Purity Loss on drying Sulphated ash Arsenic Lead Not more than 11 % (105 C, 3 hours) Not more than 0,2 % (expressed on dry weight basis) Not more than 3 mg/kg expressed on dry weight basis Not more than 2 mg/kg (expressed on dry weight basis)
E 960 STEVIOL GLYCOSIDES Synonyms Definition The manufacturing process comprises two main phases: the first involving water extraction of the leaves of the Stevia rebaudiana Bertoni plant and preliminary purification of the extract by employing ion exchange chromatography to yield a steviol glycoside primary extract, and the second involving recrystallisation of the steviol glycosides from methanol or aqueous ethanol resulting in a final product consisting mainly (at least 75 %) of stevioside and/or rebaudioside A. The additive may contain residues of ion-exchange resins used in the manufacturing process. Several other related steviol glycosides that may be generated as a result of the production process, but do not occur naturally in the Stevia rebaudiana plant have been identified in small amounts (0,10 to 0,37 % w/w). Chemical name Stevioside: 13-[(2-O--D-glucopyranosyl--D-glucopyranosyl)oxy] kaur-16-en-18-oic acid, -D-glucopyranosyl ester Rebaudioside A: 13-[(2-O--D-glucopyranosyl-3-O--Dglucopyranosyl--D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, -Dglucopyranosyl ester Chemical formula Trivial name Steviol Stevioside Rebaudioside A Rebaudioside C Dulcoside A Rubusoside Steviolbioside Rebaudioside B Rebaudioside D Rebaudioside E Rebaudioside F Molecular weight and CAS No Trivial name Stevioside Formula C20H30O3 C38H60O18 C44H70O23 C44H70O22 C38H60O17 C32H50O13 C32H50O13 C38H60O18 C50H80O28 C44H70O23 C43H68O22 CAS Number 57817-89-7 Conversion factor 1,00 0,40 0,33 0,34 0,40 0,50 0,50 0,40 0,29 0,33 0,34 Molecular weight 804,87
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Rebaudioside A Assay Description Identification Solubility Stevioside and rebaudioside A
58543-16-1
967,01
Not less than 95 % stevioside, rebaudiosides A, B, C, D, E and F, steviolbioside, rubusoside and dulcoside on the dried basis. White to light yellow powder, approximately between 200 and 300 times sweeter than sucrose
Freely soluble to slightly soluble in water The main peak in the chromatogram obtained following the procedure in Method of Assay corresponds to either stevioside or rebaudioside A Between 4,5 and 7,0 (1 in 100 solution)
pH Purity Total ash Loss on drying Residual solvents
Not more than 1 % Not more than 6 % (105 C, 2h) Not more than 200 mg/kg methanol Not more than 5 000 mg/kg ethanol
Arsenic Lead
E 961 NEOTAME Synonyms N-[N-(3,3-dimethylbutyl)-L--aspartyl]-L-phenylalanine 1-methyl ester; N(3,3-dimethylbutyl)-L-aspartyl-L-phenylalanine methyl ester. Definition Neotame is manufactured by reaction under hydrogen pressure of aspartame with 3,3,-dimethylbutyraldehyde in methanol in presence of a palladium/carbon catalyst. It is isolated and purified by filtration, where diatomaceous earth may be used. After solvent removal via distillation, neotame is washed with water, isolated by centrifugation and finally vacuum dried. 165450-17-9 N-[N-(3,3-dimethylbutyl)-L--aspartyl]-L-phenylalanine 1-methyl ester C20H30N2O5 378,47 white to off-white powder Not less than 97,0 % on the dried basis
CAS Nr. Chemical name Chemical formula Molecular weight Description Assay Identification Solubility Purity Water content pH Melting range
4,75 % (w/w) at 60 C in water, soluble in ethanol and ethyl acetate
Not more than 5 % (Karl Fischer, sample size 25 5mg) 5,0-7,0 (0,5 % aqueous solution) 81 C to 84 C
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N-[(3,3-dimethylbutyl)-L--aspartyl]-Lphenylalanine Lead
Not more than 1,5 % Not more than 1 mg/kg
E 962 SALT OF ASPARTAME-ACESULFAME Synonyms Definition Aspartame-acesulfame; Aspartame-acesulfame salt The salt is prepared by heating an approximately 2:1 ratio (w/w) of aspartame and acesulfame K in solution at acidic pH and allowing crystallisation to occur. The potassium and moisture are eliminated. The product is more stable than aspartame alone.
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Transmittance Sparingly soluble water; slightly soluble in ethanol The transmittance of a 1 % solution in water determined in a 1 cm cell at 430 nm with a suitable spectrophotometer using water as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022. []D20 + 14,5 to + 16,5 Determine at a concentration of 6,2 g in 100 ml formic acid (15N) within 30 min of preparation of the solution. Divide the calculated specific rotation by 0,646 to correct for the aspartame content of the salt of aspartame-acesulfame Purity Loss on drying 5-Benzyl-3,6-dioxo-2-piperazineacetic acid Lead Not more than 0,5 % (105 C, 4 hours) Not more than 0,5 % Not more than 1 mg/kg 6-Methyl-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide salt of L-phenyl alanyl-2-methyl-L--aspartic acid C18H23O9N3S 457,46 63,0 % to 66,0 % aspartame (dry basis) and 34,0 % to 37,0 % acesulfame (acid form on a dry basis) A white, odourless, crystalline powder
Specific rotation
E 965 (i) MALTITOL Synonyms Definition D-Maltitol; Hydrogenated maltose Maltitol is obtained by hydrogenation of D-maltose. It is mainly composed of D-maltitol. It may contain small amounts of sorbitol and related polyhydric alcohols. 209-567-0 ()-D-Glucopyranosyl-1,4-D-glucitol C12H24O11 344,3
Einecs Chemical name Chemical formula Molecular weight
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Assay Description Identification Solubility Melting range Specific rotation Purity Appearance of the aqueous solution Water content Sulphated ash Reducing sugars Chlorides Sulphates Nickel Arsenic Lead
Content not less than 98 % D-maltitol C12H24O11 on the anhydrous basis White crystalline powder
Very soluble in water, slightly soluble in ethanol 148 to 151 C []D20 + 105,5 to + 108,5 (5 % w/v solution)
The solution is clear and colourless Not more than 1 % (Karl Fischer method) Not more than 0,1 % (expressed on an anhydrous basis) Not more than 0,1 % (expressed as glucose on an anhydrous basis) Not more than 50 mg/kg (expressed on anhydrous basis) Not more than 100 mg/kg (expressed on anhydrous basis) Not more than 2 mg/kg (expressed on anhydrous basis) Not more than 3 mg/kg (expressed on anhydrous basis) Not more than 1 mg/kg (expressed on anhydrous basis)
E 965 (ii) MALTITOL SYRUP Synonyms Definition Hydrogenated high-maltose-glucose syrup; Hydrogenated glucose syrup; Maltitol liquid A mixture consisting of mainly maltitol with sorbitol and hydrogenated oligo- and polysaccharides. It is manufactured by the catalytic hydroge nation of high maltose-content glucose syrup or by the hydrogenation of its individual components followed by blending. The article of commerce is supplied both as a syrup and as a solid product.
Einecs Chemical name Chemical formula Molecular weight Assay Content not less than 99 % of total hydrogenated saccharides on the anhydrous basis and not less than 50 % of maltitol on the anhydrous basis Colourless and odourless, clear viscous liquids or white crystalline masses
Description Identification Solubility HPLC test
Very soluble in water, slightly soluble in ethanol Comparison with an appropriate reference standard of Maltitol shows that the principle peak in the chromatogram of the test solution is similar in retention time to the principal peak in the chromatogram obtained with the reference solution (ISO 10504:1998).
Purity Appearance of the aqueous solution The solution is clear and colourless
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Water content Reducing sugars Sulphated ash Chlorides Sulphate Nickel Lead
Not more than 31 % (Karl Fischer method) Not more than 0,3 % (expressed as glucose on an anhydrous basis) Not more than 0,1 % Not more than 50 mg/kg Not more than 100 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg
E 966 LACTITOL Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Lactit; Lactositol; Lactobiosit Lactitol is manufactured via catalytic hydrogenation of lactose 209-566-5 4-O--D-Galactopyranosyl-D-glucitol C12H24O11 344,3 Not less than 95 % on the dry weight basis Crystalline powder or colourless solution. Crystalline products occur in anhydrous, monohydrate and dihydrate forms. Nickel is used as a catalyst.
Identification Solubility Specific rotation Purity Water content Other polyols Reducing sugars Chlorides Sulphates Sulphated ash Nickel Arsenic Lead Crystalline products; not more than 10,5 % (Karl Fischer method) Not more than 2,5 % (on the anhydrous basis) Not more than 0,2 % (expressed as glucose on dry weight basis) Not more than 100 mg/kg (expressed on dry weight basis) Not more than 200 mg/kg (expressed on dry weight basis) Not more than 0,1 % (expressed on dry weight basis) Not more than 2 mg/kg (expressed on dry weight basis) Not more than 3 mg/kg (expressed on dry weight basis Not more than 1 mg/kg (expressed on dry weight basis) Very soluble in water []D20 = + 13 to + 16 calculated on the anhydrous basis (10 % w/v aqueous solution)
E 967 XYLITOL Synonyms Definition Xylitol Xylitol is mainly composed of D-xylitol. The part which is not D-xylitol is composed of related substances such as L-arabinitol, galactitol, mannitol, sorbitol
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Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Melting range pH Infrared absorption spectroscopy Purity Water content Sulphated ash Reducing sugars Other polyhydric alcohols Nickel Arsenic Lead Chlorides Sulphates
201-788-0 D-xylitol C5H12O5 152,2 Not less than 98,5 % as xylitol on the anhydrous basis White, crystalline powder, practically odourless.
Very soluble in water, sparingly soluble in ethanol 92 to 96 C 5 to 7 (10 % w/v aqueous solution) Comparison with a reference standard e.g. EP or USP.
Not more than 1% (Karl-Fischer method) Not more than 0,1 % (expressed on dry weight basis) Not more than 0,2 % (expressed as glucose on dry weight basis) Not more than 1 % (expressed on dry weight basis) Not more than 2 mg/kg (expressed on dry weight basis) Not more than 3 mg/kg (expressed on dry weight basis) Not more than 1 mg/kg (expressed on dry weight basis) Not more than 100 mg/kg (expressed on dry weight basis) Not more than 200 mg/kg (expressed on dry weight basis)
E 968 ERYTHRITOL Synonyms Definition Meso-erythritol; Tetrahydroxybutane; Erythrite Obtained by fermentation of carbohydrate source by safe and suitable food grade osmophilic yeasts such as Moniliella pollinis or Moniliella megachilensis, followed by purification and drying 205-737-3 1,2,3,4-Butanetetrol C4H10O4 122,12 Not less than 99 % after drying White, odourless, non-hygroscopic, heat-stable crystals with a sweetness of approximately 60-80 % that of sucrose.
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Melting range
Freely soluble in water, slightly soluble in ethanol, insoluble in diethyl ether. 119-123 C
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Purity Loss on drying Sulphated ash Reducing substances Ribitol and glycerol Lead Not more than 0,2 % (70 C, 6 hours, in a vacuum desiccator) Not more than 0,1 % Not more than 0,3 % expressed as D-glucose Not more than 0,1 % Not more than 0,5 mg/kg
E 999 QUILLAIA EXTRACT Synonyms Definition Soapbark extract; Quillay bark extract; Panama bark extract; Quillai extract; Murillo bark extract; China bark extract Quillaia extract is obtained by aqueous extraction of Quillaia saponaria Molina, or other Quillaia species, trees of the family Rosaceae. It contains a number of triterpenoid saponins consisting of glycosides of quillaic acid. Some sugars including glucose, galactose, arabinose, xylose, and rhamnose are also present, along with tannin, calcium oxalate and other minor components
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification pH Purity Water content Arsenic Lead Mercury Not more than 6,0 % (Karl Fischer method) (powder form only) Not more than 2 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Between 3,7 and 5,5 (4 % solution) Quillaia extract in the powder form is light brown with a pink tinge. It is also available as an aqueous solution
E 1103 INVERTASE Synonyms Definition Einecs Enzyme Commission No Systematic name Chemical name Chemical formula Invertase is produced from Saccharomyces cerevisiae 232-615-7 EC 3.2.1.26 -D-Fructofuranoside fructohydrolase
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Molecular weight Assay Description Identification Purity Arsenic Lead Cadmium Microbiological criteria Total bacterial count Salmonella spp. Coliforms Escherichia coli Not more than 50 000 colonies per gram Absent in 25 g Not more than 30 colonies per gram Absent in 25 g Not more than 3 mg/kg Not more than 5 mg/kg Not more than 0,5 mg/kg
E 1105 LYSOZYME Synonyms Definition Lysozyme hydrochloride; Muramidase Lysozyme is a linear polypeptide obtained from hens' egg whites consisting of 129 amino acids. It possesses enzymatic activity in its ability to hydrolyse the (1-4) linkages between N-acetylmuramic acid and N-acetylglucosamine in the outer membranes of bacterial species, in particular gram-positive organisms. Is usually obtained as the hydro chloride 232-620-4 EC 3.2.1.17
Einecs Enzyme Commission No Chemical name Chemical formula Molecular weight Assay Description Identification Isoelectric point pH Spectrophotometry Purity Water content Residue on ignition Nitrogen Arsenic Lead Mercury
About 14 000 Content not less than 950 mg/g on the anhydrous basis White, odourless powder having a slightly sweet taste
10,7 Between 3,0 and 3,6 (2 % aqueous solution) Absorption maximum of an aqueous solution (25 mg/100 ml) at 281 nm, a minimum at 252 nm
Not more than 6,0 % (Karl Fischer method) (powder form only) Not more than 1,5 % Not less than 16,8 % and not more than 17,8 % Not more than 1 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg
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Microbiological criteria Total bacterial count Salmonella spp. Staphylococcus aureus Escherichia coli Not more than 5 104 colonies per gram Absent in 25 g Absent in 1 g Absent in 1 g
E 1200 POLYDEXTROSE Synonyms Definition Modified polydextroses Randomly bonded glucose polymers with some sorbitol end-groups, and with citric acid or phosphoric acid residues attached to the polymers by mono or diester bonds. They are obtained by melting and condensation of the ingredients and consist of approximately 90 parts D-glucose, 10 parts sorbitol and 1 part citric acid and/or 0,1 part phosphoric acid. The 1,6-glucosidic linkage predominates in the polymers but other linkages are present. The products contain small quantities of free glucose, sorbitol, levoglucosan (1,6-anhydro-Dglucose) and citric acid and may be neutralised with any food grade base and/or decolourised and deionised for further purification. The products may also be partially hydrogenated with Raney nickel catalyst to reduce residual glucose. Polydextrose-N is neutralised poly dextrose
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for sugar Test for reducing sugar pH Passes test Passes test Between 2,5 and 7,0 for polydextrose (10 % solution) Between 5,0 and 6,0 for polydextrose-N (10 % solution) Purity Water content Sulphated ash Not more than 4,0 % (Karl Fischer method) Not more than 0,3 % (polydextrose) Not more than 2,0 % (polydextrose N) Nickel 1,6-Anhydro-D-glucose Glucose and sorbitol Molecular weight limit Not more than 2 mg/kg for hydrogenated polydextroses Not more than 4,0 % on the ash-free and the dried basis Not more than 6,0 % combined on the ash-free and the dried basis; glucose and sorbitol are determined separately Negative test for polymers of molecular weight greater than 22 000 Content not less than 90 % of polymer on the ash free and anhydrous basis White to light tan-coloured solid. Polydextroses dissolve in water to give a clear, colourless to straw coloured solution
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5-Hydroxy-methylfurfural
Not more than 0,1 % (polydextrose) Not more than 0,05 % (polydextrose-N)
Lead
Not more than 0,5 mg/kg
E 1201 POLYVINYLPYRROLIDONE Synonyms Definition Einecs Chemical name Chemical formula Average molecular weight Assay Description Identification Solubility pH Purity Water content Total ash Aldehyde Free-N-vinylpyrrolidone Hydrazine Lead Not more than 5 % (Karl Fischer) Not more than 0,1 % Not more than 500 mg/kg (as acetaldehyde) Not more than 10 mg/kg Not more than 1 mg/kg Not more than 2 mg/kg Soluble in water and in ethanol. Insoluble in ether Between 3,0 and 7,0 (5 % solution) Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene] (C6H9NO)n Not less than 25 000 Content not less than 11,5 % and not more than 12,8 % of nitrogen (N) on the anhydrous basis White or nearly white powder Povidone; PVP; Soluble polyvinylpyrrolidone
E 1202 POLYVINYLPOLYPYRROLIDONE Synonyms Definition Crospovidone; Cross-linked polyvidone; Insoluble polyvinylpyrrolidone Polyvinylpolypyrrolidone is a poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene], cross linked in a random fashion. It is produced by the polymerisation of N-vinyl-2-pyrrolidone in the presence of either caustic catalyst or N, N'-divinyl-imidazolidone. Due to its insolubility in all common solvents the molecular weight range is not amenable to analytical determination
Einecs Chemical name Chemical formula Molecular weight Assay Content not less than 11 % and not more than 12,8 % nitrogen (N) on the anhydrous basis Polyvinylpyrrolidone; poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene] (C6H9NO)n
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Description Identification Solubility pH Purity Water content Sulphated ash Water-soluble matter Free-N-vinylpyrrolidone Free-N,N'-divinyl-imidazolidone Lead
A white hygroscopic powder with a faint, non-objectionable odour
Insoluble in water, ethanol and ether Between 5,0 and 8,0 (1 % suspension in water)
Not more than 6 % (Karl Fischer) Not more than 0,4 % Not more than 1 % Not more than 10 mg/kg Not more than 2 mg/kg Not more than 2 mg/kg
E 1203 POLYVINYL ALCOHOL Synonyms Definition Vinyl alcohol polymer, PVOH Polyvinyl alcohol is a synthetic resin prepared by the polymerisation of vinyl acetate, followed by partial hydrolysis of the ester in the presence of an alkaline catalyst. The physical characteristics of the product depend on the degree of polymerisation and the degree of hydrolysis. Ethenol homopolymer (C2H3OR)n where R = H or COCH3 Odourless, tasteless, translucent, white or cream-coloured granular powder
Chemical name Chemical formula Description Identification Solubility Precipitation reaction
Soluble in water; sparingly soluble in ethanol Dissolve 0,25 g of the sample in 5 ml of water with warming and let the solution cool to room temperature. The addition of 10 ml of ethanol to this solution leads to a white, turbid or flocculent precipi tate. Dissolve 0,01 g of the sample in 100 ml of water with warming and let the solution cool to room temperature. A blue colour is produced when adding (to 5 ml solution) one drop of iodine test solution (TS) and a few drops of boric acid solution Dissolve 0,5 g of the sample in 10 ml of water with warming and let the solution cool to room temperature. A dark red to blue colour is produced after adding one drop of iodine TS to 5 ml of solution.
Colour reaction
Viscosity Purity Water insoluble matter Ester value Degree of hydrolysis Acid value
4,8 to 5,8 mPa.s (4 % solution at 20 C) corresponding to an average molecular weight of 26 000-30 000 Da
Not more than 0,1 % Between 125 and 153 mg KOH/g 86,5 to 89,0% Not more than 3,0
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Solvent residues pH Loss on drying Residue in ignition Lead
Not more than 1,0 % Methanol, 1,0 % Methyl acetate 5,0 to 6,5 (4 % solution) Not more than 5,0 % (105 C, 3 hours) Not more than 1,0 % Not more than 2 mg/kg
E 1204 PULLULAN Synonyms Definition Linear, neutral glucan consisting mainly of maltotriose units connected by -1,6 glycosidic bonds. It is produced by fermentation from a foodgrade hydrolysed starch using a non-toxin-producing strain of Aureo basidium pullulans. After completion of the fermentation, the fungal cells are removed by microfiltration, the filtrate is heat-sterilised and pigments and other impurities are removed by adsorption and ion exchange chromatography 232-945-1
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility pH Precipitation with polyethylene glycol 600 Depolymerisation with pullulanase
(C6H10O5)n
Not less than 90 % of glucan on the dried basis White to off-white odourless powder
Soluble in water, practically insoluble in ethanol 5,0 to 7,0 (10 % solution) Add 2 ml of polyethylene glycol 600 to 10 ml of a 2 % aqueous solution of pullulan. A white precipitate is formed Prepare two test tubes each with 10 ml of a 10 % pullulan solution. Add 0,1 ml pullulanase solution having activity 10 units/g to one test tube, and 0,1 ml water to the other. After incubation at about 25 C for 20 minutes, the viscosity of the pullulanase-treated solution is visibly lower than that of the untreated solution 100 to 180 mm2/s (10 % w/w aqueous solution at 30 C)
Viscosity Purity Loss on drying Mono-, di- and oligosaccharides Lead Microbiological criteria Yeast and moulds Coliforms Salmonella spp.
Not more than 6 % (90 C, pressure not more than 50 mm Hg, 6 hours) Not more than 10 % expressed as glucose Not more than 1 mg/kg
Not more than 100 colonies per gram Absent in 25 g Absent in 25 g
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E 1205 BASIC METHACRYLATE COPOLYMER Synonyms Basic butylated methacrylate copolymer; amino methacrylate copolymer; aminoalkyl methacrylate copolymer E; butyl methacrylate, dimethylaminoethyl methacrylate, methyl methacrylate polymer; butyl methacrylate, methyl methacrylate, dimethylaminoethyl methacrylate polymer Basic methacrylate copolymer is manufactured by thermic controlled polymerisation of the monomers methyl methacrylate, butyl metha crylate and dimethylaminoethyl methacrylate, dissolved in propan-2ol) by using a free radical donor initiator system. An alkyl mercaptane is used as chain modifying agent. The solid polymer is milled (first milling step) and extruded and granulated under vacuum to remove residual volatile components. The granules resulting are commercialised as such or undergo a second milling step (micronisation). Poly(butyl methacrylate-co-(2-dimethylaminoethyl)methacrylate-comethyl methacrylate) 1:2:1 Poly[(CH2:C(CH3)CO2(CH2)2N(CH3)2)-co-(CH2:C(CH3)CO2CH3)-co(CH2:C(CH3)CO2(CH2)3CH3)] Approximately 47 000 g/mol
Definition
Chemical name Chemical formula Weight average molecular weight estimated by gel permeation chroma tography Particle size of powder (when used forms a film) Assay
< 50 m more than 50 % < 0,1 m 5,1-5,5 % 20,8-25,5 % dimethylaminoethyl (DMAE) groups on dry substance
(according to Ph. Eur. 2.2.20 potentio metric titration) Description Identification Infrared absorption spectroscopy Viscosity of a 12,5 % solution in 60:40 (w/w/) propan-2-ol to acetone Refractive index Solubility To be identified 3-6 mPa.s [n]D20 1,380-1,385 1 g dissolves in 7 g Methanol, Ethanol, propan-2-ol, dichloromethane, aqueous Hydrochloric acid 1N. Not soluble in petroleum ether. Purity Loss of drying Alkali value Sulphated ash Residual monomers Not more than 2,0 % (105 C, 3H) 162-198 mg KOH/g of dried substance Not more than 0,1 % Butylmethacrylate < 1 000 mg/kg Methyl methacrylate < 1 000 mg/kg Dimethylaminoethyl methacrylate < 1 000 mg/kg Solvent residues propan-2-ol < 0,5 % Butanol < 0,5 % Methanol < 0,1 % Granules are colourless to yellow tinged, the powder is white
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Arsenic Lead Mercury Copper
E 1404 OXIDISED STARCH Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Microscopic observation Iodine staining Purity Loss on drying Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches Carboxyl groups Sulphur dioxide Not more than 1,1 % (on an anhydrous basis) Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis) Arsenic Lead Mercury Not more than 1 mg/kg Not more than 2 mg/kg (on an anhydrous basis) Not more than 0,1 mg/kg Passes test (if not pregelatinised) Passes test (dark blue to light red colour) White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles Oxidised starch is starch treated with sodium hypochlorite
E 1410 MONOSTARCH PHOSPHATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Monostarch phosphate is starch esterified with ortho-phosphoric acid, or sodium or potassium ortho-phosphate or sodium tripolyphosphate
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Assay Description Identification Microscopic observation Iodine staining Purity Loss on drying Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches Residual phosphate Not more than 0,5 % (as P) for wheat or potato starch (on an anhydrous basis) Not more than 0,4 % (as P) for other starches (on an anhydrous basis) Sulphur dioxide Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis) Arsenic Lead Mercury Not more than 1 mg/kg Not more than 2 mg/kg (on an anhydrous basis) Not more than 0,1 mg/kg Passes test (if not pregelatinised) Passes test (dark blue to light red colour) White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
E 1412 DISTARCH PHOSPHATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Microscopic observation Iodine staining Purity Loss on drying Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches Passes test (if not pregelatinised) Passes test (dark blue to light red colour) White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles Distarch phosphate is starch cross-linked with sodium trimeta phosphate or phosphorus oxychloride
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Residual phosphate
Not more than 0,5 % (as P) for wheat or potato starch (on an anhydrous basis) Not more than 0,4 % (as P) for other starches (on an anhydrous basis)
Sulphur dioxide
Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
Not more than 1 mg/kg Not more than 2 mg/kg (on an anhydrous basis) Not more than 0,1 mg/kg
E 1413 PHOSPHATED DISTARCH PHOSPHATE Synonyms Definition Phosphated distarch phosphate is starch having undergone a combination of treatments as described for monostarch phosphate and for distarch phosphate
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Microscopic observation Iodine staining Purity Loss on drying Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches Residual phosphate Not more than 0,5 % (as P) for wheat or potato starch (on an anhydrous basis) Not more than 0,4 % (as P) for other starches (on an anhydrous basis) Sulphur dioxide Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis) Arsenic Lead Mercury Not more than 1 mg/kg Not more than 2 mg/kg (on an anhydrous basis) Not more than 0,1 mg/kg Passes test (if not pregelatinised) Passes test (dark blue to light red colour) White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
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E 1414 ACETYLATED DISTARCH PHOSPHATE Synonyms Definition Acetylated distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and esterified by acetic anhydride or vinyl acetate
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Microscopic observation Iodine staining Purity Loss on drying Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches Acetyl groups Residual phosphate Not more than 2,5 % (on an anhydrous basis) Not more than 0,14 % (as P) for wheat or potato starch (on an anhydrous basis) Not more than 0,04 % (as P) for other starches (on an anhydrous basis) Vinyl acetate Sulphur dioxide Not more than 0,1 mg/kg (on an anhydrous basis) Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis) Arsenic Lead Mercury Not more than 1 mg/kg Not more than 2 mg/kg (on an anhydrous basis) Not more than 0,1 mg/kg Passes test (if not pregelatinised) Passes test (dark blue to light red colour) White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
E 1420 ACETYLATED STARCH Synonyms Definition Einecs Chemical name Chemical formula Starch acetate Acetylated starch is starch esterified with acetic anhydride or vinyl acetate
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Molecular weight Assay Description Identification Microscopic observation Iodine staining Purity Loss on drying Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches Acetyl groups Vinyl acetate Sulphur dioxide Not more than 2,5 % (on an anhydrous basis) Not more than 0,1 mg/kg (on an anhydrous basis) Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis) Arsenic Lead Mercury Not more than 1 mg/kg Not more than 2 mg/kg (on an anhydrous basis) Not more than 0,1 mg/kg Passes test (if not pregelatinised) Passes test (dark blue to light red colour) White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
E 1422 ACETYLATED DISTARCH ADIPATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Microscopic observation Iodine staining Purity Loss on drying Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches Acetyl groups Adipate groups Not more than 2,5 % (on an anhydrous basis) Not more than 0,135 % (on an anhydrous basis) Passes test (if not pregelatinised) Passes test (dark blue to light red colour) White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles Acetylated distarch adipate is starch cross-linked with adipic anhydride and esterified with acetic anhydride
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Sulphur dioxide
E 1440 HYDROXYPROPYL STARCH Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Microscopic observation Iodine staining Purity Loss on drying Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches Hydroxypropyl groups Propylene chlorohydrin Sulphur dioxide Not more than 7,0 % (on an anhydrous basis) Not more than 1 mg/kg (on an anhydrous basis) Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis) Arsenic Lead Mercury Not more than 1 mg/kg Not more than 2 mg/kg (on an anhydrous basis) Not more than 0,1 mg/kg Passes test (if not pregelatinised) Passes test (dark blue to light red colour) White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles Hydroxypropyl starch is starch etherified with propylene oxide
E 1442 HYDROXYPROPYL DISTARCH PHOSPHATE Synonyms Definition Hydroxypropyl distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and etherified with propylene oxide
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Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Microscopic observation Iodine staining Purity Loss on drying Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches Hydroxypropyl groups Residual phosphate Not more than 7,0 % (on an anhydrous basis) Not more than 0,14 % (as P) for wheat or potato starch (on an anhydrous basis) Not more than 0,04 % (as P) for other starches (on an anhydrous basis) Propylene chlorohydrin Sulphur dioxide Not more than 1 mg/kg (on an anhydrous basis) Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis) Arsenic Lead Mercury Not more than 1 mg/kg Not more than 2 mg/kg (on an anhydrous basis) Not more than 0,1 mg/kg Passes test (if not pregelatinised) Passes test (dark blue to light red colour) White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
E 1450 STARCH SODIUM OCTENYL SUCCINATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles SSOS Starch sodium octenyl succinate is starch esterified with octenylsuccinic anhydride
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Identification Microscopic observation Iodine staining Purity Loss on drying Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches Octenylsuccinyl groups Octenylsuccinic acid residue Sulphur dioxide Not more than 3 % (on an anhydrous basis) Not more than 0,3 % (on an anhydrous basis) Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis) Arsenic Lead Mercury Not more than 1 mg/kg Not more than 2 mg/kg (on an anhydrous basis) Not more than 0,1 mg/kg Passes test (if not pregelatinised) Passes test (dark blue to light red colour)
E 1451 ACETYLATED OXIDISED STARCH Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Microscopic observation Iodine staining Purity Loss on drying Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches Carboxyl groups Acetyl groups Not more than 1,3 % (on an anhydrous basis) Not more than 2,5 % (on an anhydrous basis) Passes test (if not pregelatinised) Passes test (dark blue to light red colour) White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles Acetylated oxidised starch is starch treated with sodium hypochlorite followed by esterification with acetic anhydride
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Sulphur dioxide
E 1452 STARCH ALUMINIUM OCTENYL SUCCINATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Microscopic observation Iodine staining Purity Loss on drying Octenylsuccinyl groups Octenylsuccinic acid residue Sulphur dioxide Not more than 21,0 % Not more than 3 % (on an anhydrous basis) Not more than 0,3 % (on an anhydrous basis) Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for the other modified starches, unless otherwise specified (on an anhydrous basis) Arsenic Lead Mercury Aluminium Not more than 1 mg/kg Not more than 2 mg/kg (on an anhydrous basis) Not more than 0,1 mg/kg Not more than 0,3 % (on an anhydrous basis) Passes test (if not pregelatinised) Passes test (dark blue to light red colour) White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles Starch aluminium octenyl succinate is starch esterified with octe nylsuccinic anhydride and treated with aluminium sulphate
E 1505 TRIETHYL CITRATE Synonyms Definition Einecs 201-070-7 Ethyl citrate
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Chemical name Chemical formula Molecular weight Assay Description Identification Specific gravity (25 C/25 C) Refractive index Purity Water content Acidity Arsenic Lead
Triethyl-2-hydroxypropan-1,2,3-tricarboxylate C12H20O7 276,29 Content not less than 99,0 % Odourless, practically colourless, oily liquid
1,135-1,139 [n]D20: 1,439-1,441
Not more than 0,25 % (Karl Fischer method) Not more than 0,02 % (as citric acid) Not more than 3 mg/kg Not more than 2 mg/kg
E 1517 GLYCERYL DIACETATE Synonyms Definition Diacetin Glyceryl diacetate consist predominantly of a mixture of the 1, 2- and 1,3-diacetates of glycerol, with minor amounts of the mono- and triesters
Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Test for glycerol Test for acetate Specific gravity (20 C/20 C) Boiling range Purity Total ash Acidity Arsenic Lead Not more than 0,02 % Not more than 0,4 % (as acetic acid) Not more than 3 mg/kg Not more than 2 mg/kg Soluble in water. Miscible with ethanol Passes test Passes test 1,175-1,195 Between 259 and 261 C Glyceryl diacetate; 1, 2, 3-propanetriol diacetate C7H12O5 176,17 Not less than 94,0 % Clear, colourless, hygroscopic, somewhat oily liquid with a slight, fatty odour
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E 1518 GLYCERYL TRIACETATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Test for acetate Test for glycerol Refractive index Specific gravity (25 C/25 C) Boiling range Purity Water content Sulphated ash Arsenic Lead Not more than 0,2 % (Karl Fischer method) Not more than 0,02 % (as citric acid) Not more than 3 mg/kg Not more than 2 mg/kg Passes test Passes test [n]D25 between 1,429 and 1,431 Between 1,154 and 1,158 Between 258 and 270 C 203-051-9 Glyceryl triacetate C9H14O6 218,21 Content not less than 98,0 % Colourless, somewhat oily liquid having a slightly fatty odour Triacetin
E 1519 BENZYL ALCOHOL Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Refractive index Specific gravity (25 C/25 C) Test for peroxides Distillation range Soluble in water, ethanol and ether [n]D20 1,538-1,541 1,042-1,047 Passes test Not less than 95 % v/v distils between 202 and 208 C Benzyl alcohol; Phenylmethanol C7H8O 108,14 Not less than 98,0 % Colourless, clear liquid with a faint, aromatic odour Phenylcarbinol; Phenylmethyl hydroxytoluene alcohol; Benzenemethanol; Alpha-
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Purity Acid value Aldehydes Lead Not more than 0,5 Not more than 0,2 % v/v (as benzaldehyde) Not more than 2 mg/kg
E 1520 PROPANE-1,2-DIOL Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description Identification Solubility Specific gravity (20 C/20 C) Refractive index Purity Distillation test Sulphated ash Water content Lead 99,5% of the product distils between 185-189 C. The remaining 0,5% consists mainly of dimers and traces of trimers from propylene glycol. Not more than 0,07 % Not more than 1,0 % (Karl Fischer method) Not more than 2 mg/kg Soluble in water, ethanol and acetone 1,035-1,040 [n]D20: 1,431-1,433 200-338-0 1,2-dihydroxypropane C3H8O2 76,10 Content not less than 99,5 % on the anhydrous basis Clear, colourless, hygroscopic, viscous liquid Propylene glycol
E 1521 POLYETHYLENE GLYCOL Synonyms Definition Chemical name Chemical formula Average molecular weight Assay PEG; Macrogol; Polyethylene oxide Addition polymers of ethylene oxide and water usually designated by a number roughly corresponding to the molecular weight. alpha-Hydro-omega-hydroxypoly (oxy-1,2-ethanediol) (C2H4O)n H2O (n = number of ethylene oxide units corresponding to a molecular weight of 6 000, about 140) 380 to 9 000 Da PEG 400: Not less than 95 % and not more than 105 % PEG 3000: Not less than 90 % and not more than 110 % PEG 3350: Not less than 90 % and not more than 110 % PEG 4000: Not less than 90 % and not more than 110 % PEG 6000:Not less than 90 % and not more than 110 % PEG 8000: Not less than 87,5 % and not more than 112,5 %
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Description
PEG 400 is a clear, viscous, colourless or almost colourless hygroscopic liquid PEG 3000, PEG 3350, PEG 4000, PEG 6000 and PEG 8000 are white or almost white solids with a waxy or paraffin-like appearance
Identification Melting range PEG 400: 4-8 C PEG 3000: 50-56 C PEG 3350: 53-57 C PEG 4000: 53-59 C PEG 6000:55-61 C PEG 8000: 55-62 C Viscosity PEG 400: 105 to 130 mPa.s at 20 C PEG 3000: 75 to 100 mPa.s at 20 C PEG 3350: 83 to 120 mPa.s at 20 C PEG 4000: 110 to 170 mPa.s at 20 C PEG 6000: 200 to 270 mPa.s at 20 C PEG 8000: 260 to 510 mPa.s at 20 C For polyethylene glycols having a average molecular weight greater than 400, the viscosity is determined on a 50 per cent m/m solution of the candidate substance in water Solubility PEG 400 is miscible with water, very soluble in acetone, in alcohol and in methylene chloride, practically insoluble in fatty oils and in mineral oils PEG 3000 and PEG 3350: very soluble in water and in methylene chloride, very slightly soluble in alcohol, practically insoluble in fatty oils and in mineral oils PEG 4000, PEG 6000 and PEG 8000: very soluble in water and in methylene chloride, practically insoluble in alcohol and in fatty oils and in mineral oils. Purity Hydroxyl value PEG 400: 264-300 PEG 3000: 34-42 PEG 3350: 30-38 PEG 4000: 25-32 PEG 6000: 16-22 PEG 8000: 12-16 Sulphated ash 1,4-Dioxane Ethylene oxide Ethylene glycol and diethylene glycol Lead Not more than 0,2 % Not more than 10 mg/kg Not more than 0,2 mg/kg Total not more than 0,25 % w/w individually or in combination Not more than 1 mg/kg

EC Regulation No. 231/2012 PDF

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22.3.

Official Journal of the European Union

Official Journal of the European Union

Official Journal of the European Union

Official Journal of the European Union

HAS ADOPTED THIS REGULATION:

Done at Brussels, 9 March 2012. For the Commission The President

Official Journal of the European Union

HCl insoluble matter a insoluble matter Ether extractable matter

II 1-(4-Hydroxyphenyl)-7-(4-hydroxy-3-methoxy-phenyl-)hepta-1,6diene-3,5-dione III 1,7-Bis(4-hydroxyphenyl)hepta-1,6-diene-3,5-dione Chemical formula I C21H20O6

Orange-yellow crystalline powder

Official Journal of the European Union

Chemical formula Molecular weight Assay

Official Journal of the European Union

[]D20 between 115 and 140 in a 0,05 N sodium hydroxide solution

Official Journal of the European Union

Description Identification Spectrometry

Yellow to orange crystalline hygroscopic powder, with slight odour

Specific rotation Purity Loss on drying

[]D20 between + 38 and + 42 in a 5 molar HCl solution

Sulphated ash Inorganic phosphate Subsidiary colouring matters

Primary aromatic amines Arsenic Lead Mercury Cadmium

Official Journal of the European Union

Chemical formula Molecular weight Assay

Light orange powder or granules Yellow

Maximum in water at ca. 426 nm

Not more than 0,2 % Not more than 1,0 %

Total not more than 0,5 %

Official Journal of the European Union

Chemical formula Molecular weight Assay

Official Journal of the European Union

Total not more than 0,5 %

Official Journal of the European Union

Total not more than 0,5 %

Official Journal of the European Union

Chemical formula Molecular weight Assay

Official Journal of the European Union

Einecs Chemical name

222-657-4 Disodium sulfonate 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-

Chemical formula Molecular weight Assay

Red to maroon powder or granules Red

Maximum in water at ca. 516 nm

Not more than 0,2 % Not more than 1 %

9 > > > > = > > > > > ;

Total not more than 0,5 %

Official Journal of the European Union

Chemical formula Molecular weight Assay

Total not more than 0,5 %

Official Journal of the European Union

Chemical formula Molecular weight Assay

Total not more than 0,5 %

Not more than 0,01 % (calculated as aniline)

Official Journal of the European Union

Chemical formula Molecular weight Assay

Not more than 20 mg/kg

Official Journal of the European Union

Organic compounds colouring matters: Tri-iodoresorcinol

Not more than 0,2 % Not more than 0,2 %

Chemical formula Molecular weight Assay