2012R0231 — EN — 19.06.2013 — 003.001

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►B 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) (OJ L 083, 22.3.2012, p.1)

Amended by:









▼B

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, 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) 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. (2) 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 foodstuffs ( 5 ) should be updated and taken over to this Regulation. As a consequence, those Directives should be repealed. (3) 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). (4) 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. (5) 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 manufacturers. Therefore, current specifications for those food additives should not be taken over to this Regulation. (6) 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. (7) 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 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 manufacturing processes, by taking into account the recent recommendations of the Authority on a reduction of the intake of arsenic, especially in the inorganic form ( 8 ). 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. (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. (9) Specifications should not make reference to classes as there is no added value in this reference. (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. (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 ( 9 ). Therefore the specifications established by this Regulation should refer to those various names. (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 in carageenan (E 407) and processed euchema seaweed (E 407 a), for particular microbiological criteria in agar (E 406) and for Salmonella spp. content in mannitol (E 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 ( 10 ). 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. (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) The solid form of lactic acid (E 270) should also be included in the specifications, as it can now be manufactured in the solid form and there is no safety concern. (17) 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. (18) The current specific absorption value for alpha-tocopherol (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. (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 non-discrimination it is appropriate to provide the manufacturers of food additives with a transitional period to adapt gradually to those restrictions. (20) 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 ( 11 ), according to the relevant opinion of Scientific Committee on Food expressed on 7 June 1996 ( 12 ). In this framework a maximum limit for aluminum in calcium citrate (E 333) should also be established. (21) The maximum limits for aluminium in calcium phosphates (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 ( 13 ). 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. (22) 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. (23) 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 ( 14 ), maximum limits should be set for the contaminant pentachlorophenol in guar gum (E 412). (24) According to recital 48 of Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs ( 15 ) 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. (25) 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). (26) 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. (27) 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 estimation of the free acidic groups. This is in accordance with the 71st report on food additives from JECFA ( 16 ) where such change was adopted for mono- and diacetyltartaric acid esters of mono- and diglycerides of fatty acids (E 472 e). (28) 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 ( 17 ). 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. (30) In the current entry ‘assay’ for thaumatin (E 957) a calculation 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). (31) The Authority evaluated the safety of steviol glycosides, as a sweetener and expressed its opinion of 10 March 2010 ( 18 ). The use of steviol glycosides, which have been 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. (32) Due to a taxonomic change, current specifications for source materials (yeasts) used in the manufacturing of erythritol (E 968) should be updated. (33) 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. (34) 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. (35) 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. (36) 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’. (37) 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, Whereas: HAS ADOPTED THIS REGULATION:







Article 1

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.

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.









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. HCl insoluble matter Not more than 0,5 % ΝaΟΗ insoluble matter Νot more than 0,5 %, for Ε 127 erythrosine only Ether extractable matter Not more than 0,2 % (under neutral conditions) Specific purity criteria for the corresponding colours are applicable.

E 100 CURCUMIN







Synonyms CI Natural Yellow 3; Turmeric Yellow; Diferoyl Methane Definition Curcumin is obtained by solvent extraction of turmeric i.e. the ground rhizomes of strains of Curcuma longa L. In order to obtain a concentrated 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: ethylacetate, acetone, carbon dioxide, dichloromethane, n-butanol, methanol, ethanol, hexane, propan-2-ol. Colour Index No 75300 Einecs 207-280-5 Chemical name 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-1,6-diene-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 I. 368,39 II. 338,39 III. 308,39 Assay Content not less than 90 % total colouring matters 1 607 at ca. 426 nm in ethanol Description Orange-yellow crystalline powder Identification Spectrometry Maximum in ethanol at ca. 426 nm Melting range 179 °C-182 °C Purity Solvent residues Ethylacetate Not more than 50 mg/kg, singly or in combination Acetone n-butanol Methanol Ethanol Hexane Propan-2-ol Dichloromethane: not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 101 (i) RIBOFLAVIN







Synonyms Lactoflavin; Definition Colour Index No Einecs 201-507-1 Chemical name 7,8-Dimethyl-10-(D-ribo-2,3,4,5-tetrahydroxypentyl)benzo(g)pteridine-2,4(3H,10H)-dione; 7,8-dimethyl-10-(1′-D-ribityl)isoalloxazine Chemical formula C17H20N4O6 Molecular weight 376,37 Assay Content not less than 98 % on the anhydrous basis 328 at ca. 444 nm in aqueous solution Description Yellow to orange-yellow crystalline powder, with slight odour Identification Spectrometry The ratio A375/A267 is between 0,31 and 0,33 in aqueous solution The ratio A444/A267 is between 0,36 and 0,39 Maximum in water at ca. 375 nm Specific rotation [α]D 20 between – 115° and – 140° in a 0,05 N sodium hydroxide solution Purity Loss on drying Not more than 1,5 % (105 °C, 4 hours) Sulphated ash Not more than 0,1 % Primary aromatic amines Not more than 100 mg/kg (calculated as aniline) Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

E 101 (ii) RIBOFLAVIN-5′-PHOSPHATE







Synonyms Riboflavin-5′-phosphate sodium Definition These specifications apply to riboflavin 5′-phosphate together with minor amounts of free riboflavin and riboflavin diphosphate. Colour Index No Einecs 204-988-6 Chemical name Monosodium(2R,3R,4S)-5-(3′)10′-dihydro-7′,8′-dimethyl-2′,4′-dioxo-10′-benzo[γ]pteridinyl)-2,3,4-trihydroxypentyl phosphate; monosodium salt of 5′-monophosphate ester of riboflavin Chemical formula For the dihydrate form: C17H20N4NaO9P · 2H2O For the anhydrous form: C17H20N4NaO9P Molecular weight 514,36 Assay Content not less than 95 % total colouring matters calculated as C17H20N4NaO9P.2H2O 250 at ca. 375 nm in aqueous solution Description Yellow to orange crystalline hygroscopic powder, with slight odour Identification Spectrometry The ratio A375/A267 is between 0,30 and 0,34 in aqueous solution The ratio A444/A267 is between 0,35 and 0,40 Maximum in water at ca. 375 nm Specific rotation [α]D 20 between + 38° and + 42° in a 5 molar HCl solution Purity Loss on drying Not more than 8 % (100 °C, 5 hours in vacuum over P2O5) for the dihydrate form Sulphated ash Not more than 25 % Inorganic phosphate Not more than 1,0 % (calculated as PO4 on the anhydrous basis) Subsidiary colouring matters Riboflavin (free): Not more than 6 % Riboflavine diphosphate: Not more than 6 % Primary aromatic amines Not more than 70 mg/kg (calculated as aniline) Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

E 102 TARTRAZINE







Synonyms CI Food Yellow 4 Definition 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-(4sulphophenyl)-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-sulfonatophenylazo)-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 19140 Einecs 217-699-5 Chemical name Trisodium-5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate Chemical formula C16H9N4Na3O9S2 Molecular weight 534,37 Assay Content not less than 85 % total colouring matters calculated as the sodium salt 530 at ca. 426 nm in aqueous solution Description Light orange powder or granules Appearance of the aqueous solution Yellow Identification Spectrometry Maximum in water at ca. 426 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 1,0 % Organic compounds other than colouring matters: 4-hydrazinobenzene sulfonic acid Total not more than 0,5 % 4-aminobenzene-1-sulfonic acid 5-oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid 4,4′-diazoaminodi(benzene sulfonic acid) Tetrahydroxysuccinic acid Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 104 QUINOLINE YELLOW







Synonyms CI Food Yellow 13 Definition Quinoline Yellow is prepared by sulfonating 2-(2-quinolyl) indan-1,3-dione or a mixture containing about two thirds 2-(2-quinolyl)indane-1,3-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 47005 Einecs 305-897-5 Chemical name The disodium salts of the disulfonates of 2-(2-quinolyl) indan-1,3-dione (principal component) Chemical formula C18H9N Na2O8S2 (principal component) Molecular weight 477,38 (principal component) Assay 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-1,3-dione-disulfonates — not more than 15 % shall be sodium 2-(2-quinolyl) indan-1,3-dione-monosulfonates — not more than 7,0 % shall be trisodium 2-(2-quinolyl) indan-1,3-dione-trisulfonate 865 (principal component) at ca. 411 nm in aqueous acetic acid solution Description Yellow powder or granules Appearance of the aqueous solution Yellow Identification Spectrometry Maximum in aqueous acetic acid solution of pH 5 at ca. 411 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 4,0 % Organic compounds other than colouring matters: 2-methylquinoline Total not more than 0,5 % 2-methylquinoline-sulfonic acid Phthalic acid 2,6-dimethyl quinoline 2,6-dimethyl quinoline sulfonic acid 2-(2-quinolyl)indan-1,3-dione Not more than 4 mg/kg Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 110 SUNSET YELLOW FCF







Synonyms CI Food Yellow 3; Orange Yellow S Definition Sunset Yellow FCF consists essentially of disodium 2-hydroxy-1-(4-sulfonatophenylazo) 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 15985 Einecs 220-491-7 Chemical name Disodium 2-hydroxy-1-(4-sulfonatophenylazo)naphthalene-6-sulfonate Chemical formula C16H10N2Na2O7S2 Molecular weight 452,37 Assay Content not less than 85 % total colouring matters calculated as the sodium salt 555 at ca. 485 nm in aqueous solution at pH 7 Description Orange-red powder or granules Appearance of the aqueous solution Orange Identification Spectrometry Maximum in water at ca. 485 nm at pH 7 Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 5,0 % 1-(Phenylazo)-2-naphthalenol (Sudan I) Not more than 0,5 mg/kg Organic compounds other than colouring matters: 4-aminobenzene-1-sulfonic acid Total not more than 0,5 % 3-hydroxynaphthalene-2,7-disulfonic acid 6-hydroxynaphthalene-2-sulfonic acid 7-hydroxynaphthalene-1,3-disulfonic acid 4,4′-diazoaminodi(benzene sulfonic acid) 6,6′-oxydi(naphthalene-2-sulfonic acid) Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 120 COCHINEAL, CARMINIC ACID, CARMINES







Synonyms CI Natural Red 4 Definition 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. 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 75470 Einecs Cochineal: 215-680-6; carminic acid: 215-023-3; carmines: 215-724-4 Chemical name 7-β-D-glucopyranosyl-3,5,6,8-tetrahydroxy-1-methyl-9,10-dioxoanthracene-2-carboxylic acid (carminic acid); carmine is the hydrated aluminium chelate of this acid Chemical formula C22H20O13 (carminic acid) Molecular weight 492,39 (carminic acid) Assay Content not less than 2,0 % carminic acid in the extracts containing carminic acid; not less than 50 % carminic acid in the chelates. Description Red to dark red, friable, solid or powder. Cochineal extract is generally a dark red liquid but can also be dried as a powder. Identification Spectrometry Maximum in aqueous ammonia solution at ca. 518 nm Maximum in dilute hydrochloric solution at ca. 494 nm for carminic acid 139 at peak around 494 nm in dilute hydrochloric acid for carminic acid Purity Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 122 AZORUBINE, CARMOISINE







Synonyms CI Food Red 3 Definition Azorubine consists essentially of disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) 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 Einecs 222-657-4 Chemical name Disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate Chemical formula C20H12N2Na2O7S2 Molecular weight 502,44 Assay Content not less than 85 % total colouring matters, calculated as the sodium salt 510 at ca. 516 nm in aqueous solution Description Red to maroon powder or granules Appearance of the aqueous solution Red Identification Spectrometry Maximum in water at ca. 516 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 1 % Organic compounds other than colouring matters: 4-aminonaphthalene-1-sulfonic acid Total not more than 0,5 % 4-hydroxynaphthalene-1-sulfonic acid Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 123 AMARANTH







Synonyms CI Food Red 9 Definition Amaranth consists essentially of trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) 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-2,7-naphthalenedisulphonic acid. Amaranth is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No 16185 Einecs 213-022-2 Chemical name Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonate Chemical formula C20H11N2Na3O10S3 Molecular weight 604,48 Assay Content not less than 85 % total colouring matters, calculated as the sodium salt 440 at ca. 520 nm in aqueous solution Description Reddish-brown powder or granules Appearance of the aqueous solution Red Identification Spectrometry Maximum in water at ca. 520 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 3,0 % Organic compounds other than colouring matters: 4-aminonaphthalene-1-sulfonic acid Total not more than 0,5 % 3-hydroxynaphthalene-2,7-disulfonic acid 6-hydroxynaphthalene-2-sulfonic acid 7-hydroxynaphthalene-1,3-disulfonic acid 7-hydroxynaphthalene-1,3-6-trisulfonic acid Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 124 PONCEAU 4R, COCHINEAL RED A







Synonyms CI Food Red 7; New Coccine Definition Ponceau 4R consists essentially of trisodium 2-hydroxy-1-(4-sulfonato-1-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-6,8- disulphonic 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 16255 Einecs 220-036-2 Chemical name Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate Chemical formula C20H11N2Na3O10S3 Molecular weight 604,48 Assay Content not less than 80 % total colouring matters, calculated as the sodium salt. 430 at ca. 505 nm in aqueous solution Description Reddish powder or granules Appearance of the aqueous solution Red Identification Spectrometry Maximum in water at ca. 505 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 1,0 % Organic compounds other than colouring matters: 4-aminonaphthalene-1-sulfonic acid Total not more than 0,5 % 7-hydroxynaphthalene-1,3-disulfonic acid 3-hydroxynaphthalene-2,7-disulfonic acid 6-hydroxynaphthalene-2-sulfonic acid 7-hydroxynaphthalene-1,3-6-trisulfonic acid Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 127 ERYTHROSINE







Synonyms CI Food Red 14 Definition Erythrosine consists essentially of disodium 2-(2,4,5,7-tetraiodo-3-oxido-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 45430 Einecs 240-474-8 Chemical name Disodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl)benzoate monohydrate Chemical formula C20H6I4Na2O5 H2O Molecular weight 897,88 Assay Content not less than 87 % total colouring matters, calculated as the anhydrous sodium salt 1 100 at ca. 526 nm in aqueous solution at pH 7 Description Red powder or granules. Appearance of the aqueous solution Red Identification Spectrometry Maximum in water at ca. 526 nm at pH 7 Purity Inorganic iodides Not more than 0,1 % (calculated as sodium iodide) Water insoluble matter Not more than 0,2 % Subsidiary colouring matters (except fluorescein) Not more than 4,0 % Fluorescein Not more than 20 mg/kg Organic compounds other than colouring matters: Tri-iodoresorcinol Not more than 0,2 % 2-(2,4-dihydroxy-3,5-diiodobenzoyl) benzoic acid Not more than 0,2 % Ether extractable matter From a solution of pH from 7 through 8, not more than 0,2 % Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium Lakes of this colour may be used.

E 129 ALLURA RED AC







Synonyms CI Food Red 17 Definition Allura Red AC consists essentially of disodium 2-hydroxy-1-(2-methoxy-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-2-toluenesulphonic 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 16035 Einecs 247-368-0 Chemical name Disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonatophenylazo) naphthalene-6-sulfonate Chemical formula C18H14N2Na2O8S2 Molecular weight 496,42 Assay Content not less than 85 % total colouring matters, calculated as the sodium salt 540 at ca. 504 nm in aqueous solution at pH 7 Description Dark red powder or granules Appearance of the aqueous solution Red Identification Spectrometry Maximum in water at ca. 504 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 3,0 % Organic compounds other than colouring matters: 6-hydroxy-2-naphthalene sulfonic acid, sodium salt Not more than 0,3 % 4-amino-5-methoxy-2-methylbenezene sulfonic acid Not more than 0,2 % 6,6-oxybis (2-naphthalene sulfonic acid) disodium salt Not more than 1,0 % Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter From a solution of pH 7, not more than 0,2 % Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 131 PATENT BLUE V







Synonyms CI Food Blue 5 Definition Patent Blue V consists essentially of the calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene)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 42051 Einecs 222-573-8 Chemical name The calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene) 2,5-cyclohexadien-1-ylidene] diethyl-ammonium hydroxide inner salt Chemical formula Calcium compound: C27H31N2O7S2Ca1/2 Sodium compound: C27H31N2O7S2Na Molecular weight Calcium compound: 579,72 Sodium compound: 582,67 Assay Content not less than 85 % total colouring matters, calculated as the sodium salt 2 000 at ca. 638 nm in aqueous solution at pH 5 Description Dark blue powder or granules Appearance of the aqueous solution Blue Identification Spectrometry Maximum in water at 638 nm at pH 5 Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 2,0 % Organic compounds other than colouring matters: 3-hydroxy benzaldehyde Total not more than 0,5 % 3-hydroxy benzoic acid 3-hydroxy-4-sulfobenzoic acid N,N-diethylamino benzene sulfonic acid Leuco base Not more than 4,0 % Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter From a solution of pH 5 not more than 0,2 % Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 132 INDIGOTINE, INDIGO CARMINE







Synonyms CI Food Blue 1 Definition Indigotine consists essentially of a mixture of disodium 3,3′dioxo-2,2′-bi-indolylidene-5,5′-disulfonate, and disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. 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 accomplished by heating indigo (or indigo paste) in the presence of sulphuric acid. The dye is isolated and subjected to purification procedures. Colour Index No 73015 Einecs 212-728-8 Chemical name Disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,5′-disulfonate Chemical formula C16H8N2Na2O8S2 Molecular weight 466,36 Assay 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 % 480 at ca. 610 nm in aqueous solution Description Dark-blue powder or granules Appearance of the aqueous solution Blue Identification Spectrometry Maximum in water at ca. 610 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Excluding disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate: not more than 1,0 % Organic compounds other than colouring matters: Isatin-5-sulfonic acid Total not more than 0,5 % 5-sulfoanthranilic acid Anthranilic acid Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 133 BRILLIANT BLUE FCF







Synonyms CI Food Blue 2 Definition Brilliant Blue FCF consists essentially of disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(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 42090 Einecs 223-339-8 Chemical name Disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate Chemical formula C37H34N2Na2O9S3 Molecular weight 792,84 Assay Content not less than 85 % total colouring matters, calculated as the sodium salt 1 630 at ca. 630 nm in aqueous solution Description Reddish-blue powder or granules Appearance of the aqueous solution Blue Identification Spectrometry Maximum in water at ca. 630 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 6,0 % Organic compounds other than colouring matters: Sum of 2-, 3- and 4-formyl benzene sulfonic acids Not more than 1,5 % 3-((ethyl)(4-sulfophenyl) amino) methyl benzene sulfonic acid Not more than 0,3 % Leuco base Not more than 5,0 % Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % at pH 7 Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 140 (i) CHLOROPHYLLS







Synonyms CI Natural Green 3; Magnesium Chlorophyll; Magnesium Phaeophytin Definition 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. Colour Index No 75810 Einecs Chlorophylls: 215-800-7, chlorophyll a: 207-536-6, Chlorophyll b: 208-272-4 Chemical name The major colouring principles are: Phytyl (132R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-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-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[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 Assay Content of total combined Chlorophylls and their magnesium complexes is not less than 10 % 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 Maximum in chloroform at ca. 409 nm Purity Solvent residues Acetone Not more than 50 mg/kg, singly or in combination Methyl Ethyl ketone Methanol Ethanol Propan-2-ol Hexane Dichloromethane: Not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

E 140 (ii) CHLOROPHYLLINS







Synonyms CI Natural Green 5; Sodium Chlorophyllin; Potassium Chlorophyllin Definition 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 Einecs 287-483-3 Chemical name The major colouring principles in their acid forms are: — 3-(10-carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin a) — and — 3-(10-carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-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. 700 at ca. 405 nm in aqueous solution at pH 9 140 at ca. 653 nm in aqueous solution at pH 9 Description Dark green to blue/black powder Identification Spectrometry Maximum in aqueous phosphate buffer at pH 9 at ca. 405 nm and at ca. 653 nm Purity Solvent residues Acetone Not more than 50 mg/kg, singly or in combination Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane Dichloromethane: not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

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-2,7,12,18-tetramethyl-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-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[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 %. 540 at ca. 422 nm in chloroform 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 Purity Solvent residues Acetone Not more than 50 mg/kg, singly or in combination Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane Dichloromethane: not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Copper ions Not more than 200 mg/kg Total copper Not more than 8,0 % of the total copper phaeophytins

Aluminium lakes of this colour may be used.

E 141 (ii) COPPER COMPLEXES OF CHLOROPHYLLINS







Synonyms Sodium Copper Chlorophyllin; Potassium Copper Chlorophyllin; CI Natural Green 5 Definition 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 75815 Einecs Chemical name The major colouring principles in their acid forms are 3-(10-Carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate, copper complex (Copper chlorophyllin a) and 3-(10-Carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl) propionate, copper complex (Copper chlorophyllin b) 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. 565 at ca. 405 nm in aqueous phosphate buffer at pH 7,5 145 at ca. 630 nm in aqueous phosphate buffer at pH 7,5 Description Dark green to blue/black powder Identification Spectrometry Maximum in aqueous phosphate buffer at pH 7,5 at ca. 405 nm and at 630 nm Purity Solvent residues Acetone Not more than 50 mg/kg, singly or in combination Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane Dichloromethane: not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Copper ions Not more than 200 mg/kg Total copper Not more than 8,0 % of the total copper chlorophyllins

Aluminium lakes of this colour may be used.

E 142 GREEN S







Synonyms CI Food Green 4, Brilliant Green BS Definition Green S consists essentially of sodium N-[4-[[4-(dimethylamino)phenyl] 2-hydroxy-3,6-disulfo-1-naphthalenyl)methylene]-2,5-cyclohexadien-1-ylidene]-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 44090 Einecs 221-409-2 Chemical name Sodium N-[4-[[4-(dimethylamino)phenyl](2-hydroxy-3,6-disulfo-1-naphthalenyl)-methylene]2,5-cyclohexadien-1-ylidene]-N-methylmethanaminium; Sodium 5-[4-dimethylamino-α-(4-dimethyliminocyclohexa-2,5-dienylidene) benzyl]-6-hydroxy-7-sulfonato-naphthalene-2-sulfonate (alternative chemical name). Chemical formula C27H25N2NaO7S2 Molecular weight 576,63 Assay Content not less than 80 % total colouring matters calculated as the sodium salt 1 720 at ca. 632 nm in aqueous solution Description Dark blue or dark green powder or granules Appearance of the aqueous solution Blue or green Identification Spectrometry Maximum in water at ca. 632 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 1,0 % Organic compounds other than colouring matters: 4,4′-bis(dimethylamino)-benzhydryl alcohol Not more than 0,1 % 4,4′-bis(dimethylamino)-benzophenone Not more than 0,1 % 3-hydroxynaphthalene-2,7-disulfonic acid Not more than 0,2 % Leuco base Not more than 5,0 % Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 150a PLAIN CARAMEL







Synonyms Caustic caramel Definition Plain 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). To promote caramelisation, acids, alkalis and salts may be employed, with the exception of ammonium compounds and sulphites. Colour Index No Einecs 232-435-9 Chemical name Chemical formula Molecular weight Assay Description Dark brown to black liquids or solids Identification Purity Colour bound by DEAE cellulose Not more than 50 % Colour bound by phosphoryl cellulose Not more than 50 % Colour intensity (1) 0,01-0,12 Total nitrogen Not more than 0,1 % Total sulphur Not more than 0,2 % Arsenic Not more than 1 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg (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.

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 (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite and sodium bisulphite); no ammonium compounds are used. Colour Index No Einecs 232-435-9 Chemical name Chemical formula Molecular weight Assay Description Dark brown to black liquids or solids Identification Purity Colour bound by DEAE cellulose More than 50 % Colour intensity (1) 0,05-0,13 Total nitrogen Not more than 0,3 % (2) Sulphur dioxide Not more than 0,2 % (2) Total sulphur 0,3-3,5 % (2) Sulphur bound by DEAE cellulose More than 40 % Absorbance ratio of colour bound by DEAE cellulose 19-34 Absorbance ratio (A 280/560) Greater than 50 Arsenic Not more than 1 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg (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.

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 232-435-9 Chemical name Chemical formula Molecular weight Assay Description Dark brown to black liquids or solids Identification Purity Colour bound by DEAE cellulose Not more than 50 % Colour bound by phosphoryl cellulose More than 50 % Colour intensity (1) 0,08-0,36 Ammoniacal nitrogen Not more than 0,3 % (2) 4-methylimidazole Not more than 200 mg/kg (2) 2-acetyl-4-tetrahydroxy-butylimidazole Not more than 10 mg/kg (2) Total sulphur Not more than 0,2 % (2) Total nitrogen 0,7-3,3 % (2) Absorbance ratio of colour bound by phosphoryl cellulose 13-35 Arsenic Not more than 1 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg (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.

E 150d SULPHITE AMMONIA CARAMEL







Synonyms Definition Sulphite 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 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 232-435-9 Chemical name Chemical formula Molecular weight Assay Description Dark brown to black liquids or solids Identification Purity Colour bound by DEAE cellulose More than 50 % Colour intensity (1) 0,10-0,60 Ammoniacal nitrogen Not more than 0,6 % (2) Sulphur dioxide Not more than 0,2 % (2) 4-methylimidazole Not more than 250 mg/kg (2) Total nitrogen 0,3-1,7 % (2) Total sulphur 0,8-2,5 % (2) Nitrogen/sulphur ratio of alcohol precipitate 0,7-2,7 Absorbance ratio of alcohol precipitate (3) 8-14 Absorbance ratio (A 280/560) Not more than 50 Arsenic Not more than 1 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg (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. (3) 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).

E 151 BRILLIANT BLACK BN, BLACK PN







Synonyms CI Food Black 1 Definition Brilliant Black BN consists essentially of tetrasodium-4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-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 28440 Einecs 219-746-5 Chemical name Tetrasodium 4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonate Chemical formula C28H17N5Na4O14S4 Molecular weight 867,69 Assay Content not less than 80 % total colouring matters calculated as the sodium salt 530 at ca. 570 nm in solution Description Black powder or granules Appearance of the aqueous solution Black-bluish Identification Spectrometry Maximum in water at ca. 570 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 4 % (expressed on the dye content) Organic compounds other than colouring matters: 4-acetamido-5-hydroxynaphthalene-1,7-disulfonic acid Total not more than 0,8 % 4-amino-5-hydroxynaphthalene-1,7-disulfonic acid 8-aminonaphthalene-2-sulfonic acid 4,4′-diazoaminodi-(benzenesulfonic acid) Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 153 VEGETABLE CARBON







Synonyms Vegetable black Definition 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 manufacture. Colour Index No 77266 Einecs 231-153-3 Chemical name Carbon Chemical formula C Atomic weight 12,01 Assay Content not less than 95 % of carbon calculated on an anhydrous and ash-free basis Loss on drying Not more than 12 % (120 °C 4 h) Description Black, odourless powder Identification Solubility Insoluble in water and organic solvents Burning When heated to redness it burns slowly without a flame Purity Ash (Total) Not more than 4,0 % (ignition temperature: 625 °C) Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Polycyclic aromatic hydrocarbons Benzo(a)pyrene less than 50 μg/kg in the extract obtained by extraction of 1 g of the product with 10 g pure cyclohexane in a continuous extraction. Alkali soluble matter The filtrate obtained by boiling 2 g of the sample with 20 ml N sodium hydroxide and filtering shall be colourless

E 155 BROWN HT







Synonyms CI Food Brown 3 Definition Brown HT consists essentially of disodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-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 20285 Einecs 224-924-0 Chemical name Disodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo)di (naphthalene-1-sulfonate) Chemical formula C27H18N4Na2O9S2 Molecular weight 652,57 Assay Content not less than 70 % total colouring matters calculated as the sodium salt. 403 at ca. 460 nm in aqueous solution at pH 7 Description Reddish-brown powder or granules Appearance of the aqueous solution Brown Identification Spectrometry Maximum in water of pH 7 at ca. 460 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 10 % (TLC method) Organic compounds other than colouring matters: 4-aminonaphthalene- 1-sulfonic acid Not more than 0,7 % Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % in a solution of pH 7 Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 160 a (i) BETA-CAROTENE







Synonyms CI Food Orange 5 Definition These specifications apply predominantly to all trans isomer of beta-carotene together with minor amounts of other carotenoids. Diluted and stabilised preparations may have different trans-cis isomer ratios. Colour Index No 40800 Einecs 230-636-6 Chemical name Beta-carotene; beta, beta-carotene Chemical formula C40H56 Molecular weight 536,88 Assay Not less than 96 % total colouring matters (expressed as beta-carotene) 2 500 at approximately by 440 nm to 457 nm in cyclohexane Description Red to brownish-red crystals or crystalline powder Identification Spectrometry Maximum in cyclohexane at 453 nm to 456 nm Purity Sulphated ash Not more than 0,1 % Subsidiary colouring matters Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters Lead Not more than 2 mg/kg

E 160 a (ii) PLANT CAROTENES







Synonyms CI Food Orange 5 Definition 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 beta-carotene 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 75130 Einecs 230-636-6 Chemical name Chemical formula Beta-carotene: C40H56 Molecular weight Beta-carotene: 536,88 Assay 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 2 500 at approximately 440 nm to 457 nm in cyclohexane Description Identification Spectrometry Maximum in cyclohexane at 440 nm to 457 nm and 470 nm to 486 nm Purity Solvent residues Acetone Not more than 50 mg/kg, singly or in combination Methyl ethyl ketone Methanol Propan-2-ol Hexane Ethanol Dichloromethane Not more than 10 mg/kg Lead Not more than 2 mg/kg (1) Benzene not more than 0,05 % v/v.

E 160 a (iii) BETA-CAROTENE FROM Blakeslea trispora







Synonyms CI Food Orange 5 Definition 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. Colour Index No 40800 Einecs 230-636-6 Chemical name Beta-carotene; beta, beta-carotene Chemical formula C40H56 Molecular weight 536,88 Assay Not less than 96 % total colouring matters (expressed as beta-carotene) 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) Identification Spectrometry Maximum in cyclohexane at 453 nm to 456 nm Purity Solvent residues Ethyl acetate Not more than 0,8 %, singly or in combination Ethanol Isobutyl acetate: Not more than 1,0 % Propan-2-ol: Not more than 0,1 % Sulphated ash Not more than 0,2 % Subsidiary colouring matters Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters Lead Not more than 2 mg/kg Microbiological criteria Moulds Not more than 100 colonies per gram Yeasts Not more than 100 colonies per gram Salmonella spp. Absent in 25 g Escherichia coli Absent in 5 g

E 160 a (iv) ALGAL CAROTENES







Synonyms CI Food Orange 5 Definition Mixed carotenes may also be produced from strains of the algae Dunaliella salina, grown in large saline lakes located in Whyalla, South Australia. Beta-carotene is extracted using an essential oil. The preparation 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 beta-carotene accounts for the major part. Alpha-carotene, lutein, zeaxanthin 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 75130 Einecs Chemical name Chemical formula Beta-Carotene: C40H56 Molecular weight Beta-Carotene: 536,88 Assay Content of carotenes (calculated as beta-carotene) is not less than 20 % 2 500 at approximately by 440 nm to 457 nm in cyclohexane Description Identification Spectrometry Maximum in cyclohexane at 440 nm to 457 nm and 474 nm to 486 nm Purity Natural tocopherols in edible oil Not more than 0,3 % Lead Not more than 2 mg/kg

E 160 b ANNATTO, BIXIN, NORBIXIN

(i) SOLVENT-EXTRACTED BIXIN AND NORBIXIN







Synonyms CI Natural Orange 4 Definition 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 trans- forms. 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 principle. Both cis- and trans-forms may be present. Colour Index No 75120 Einecs Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7 Chemical name Bixin: 6′-Methylhydrogen-9′-cis-6,6′-diapocarotene-6,6′-dioate 6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate Norbixin: 9′cis-6,6′-Diapocarotene-6,6′-dioic acid 9′-trans-6,6′-Diapocarotene-6,6′-dioic acid Chemical formula Bixin: C25H30O4 Norbixin: C24H28O4 Molecular weight Bixin: 394,51 Norbixin: 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: 2 870 at ca. 502 nm in chloroform Norbixin: 2 870 at ca. 482 nm in KOH solution Description Reddish-brown powder, suspension or solution Identification Spectrometry Bixin: maximum in chloroform at ca. 502 nm Norbixin: maximum in dilute KOH solution at ca. 482 nm Purity Solvent residues Acetone not more than 50 mg/kg, singly or in combination Methanol Hexane Dichloromethane: not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

(ii) ALKALI EXTRACTED ANNATTO







Synonyms CI Natural Orange 4 Definition 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. Colour Index No 75120 Einecs Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7 Chemical name Bixin: 6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate 6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate Norbixin: 9′cis-6,6′-Diapocarotene-6,6′-dioic acid 6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate Chemical formula Bixin: C25H30O4 Norbixin: C24H28O4 Molecular weight Bixin: 394,51 Norbixin: 380,48 Assay Contains not less than 0,1 % of total carotenoids expressed as norbixin Norbixin: 2 870 at ca. 482 nm in KOH solution Description Reddish-brown powder, suspension or solution Identification Spectrometry Bixin: maximum in chloroform at ca. 502 nm Norbixin: maximum in dilute KOH solution at ca. 482 nm Purity Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

(iii) OIL EXTRACTED ANNATTO







Synonyms CI Natural Orange 4 Definition 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. Colour Index No 75120 Einecs Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7 Chemical name Bixin: 6′-Methylhydrogen-9′-cis-6,6′-diapocarotene-6,6′-dioate 6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate Norbixin: 9′cis-6,6′-Diapocarotene-6,6′-dioic acid 9′-trans-6,6′-Diapocarotene-6,6′-dioic acid Chemical formula Bixin: C25H30O4 Norbixin: C24H28O4 Molecular weight Bixin: 394,51 Norbixin: 380,48 Assay Contains not less than 0,1 % of total carotenoids expressed as bixin Bixin: 2 870 at ca. 502 nm in chloroform Description Reddish-brown powder, suspension or solution Identification Spectrometry Bixin: maximum in chloroform at ca. 502 nm Norbixin: maximum in dilute KOH solution at ca. 482 nm Purity Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

E 160 c PAPRIKA EXTRACT, CAPSANTHIN, CAPSORUBIN







Synonyms Paprika Oleoresin Definition 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 principles of this spice. The major colouring principles are capsanthin and capsorubin. A wide variety of other coloured compounds is known to be present. 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 Capsanthin: 207-364-1, capsorubin: 207-425-2 Chemical name Capsanthin: (3R, 3′S, 5′R)-3,3′-dihydroxy-β,κ-carotene-6-one Capsorubin: (3S, 3′S, 5R, 5R′)-3,3′-dihydroxy-κ,κ-carotene-6,6′-dione Chemical formula Capsanthin: C40H56O3 Capsorubin: C40H56O4 Molecular weight Capsanthin: 584,85 Capsorubin: 600,85 Assay Paprika extract: content not less than 7,0 % carotenoids Capsanthin/capsorubin: not less than 30 % of total carotenoids 2 100 at ca. 462 nm in acetone Description Dark-red viscous liquid Identification Spectrometry Maximum in acetone at ca. 462 nm Colour reaction 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 Not more than 50 mg/kg, singly or in combination Methanol Ethanol Acetone Hexane Propan-2-ol Dichloromethane: not more than 10 mg/kg Capsaicin Not more than 250 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

E 160 d LYCOPENE

(i) SYNTHETIC LYCOPENE







Synonyms Lycopene from chemical synthesis Definition 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. Colour Index No 75125 Einecs 207-949-1 Chemical name ψ,ψ-carotene, all-trans-lycopene, (all-E)-lycopene, (all-E)-2,6,10,14,19,23,27,31-octamethyl-2,6,8,10,12,14,16,18,20,22,24,26,30-dotriacontatridecaene Chemical formula C40H56 Molecular weight 536,85 Assay Not less than 96 % total lycopenes (not less than 70 % all-trans-lycopene) at 465-475 nm in hexane (for 100 % pure all- trans -lycopene) is 3 450 Description Red crystalline powder Identification Spectrophotometry A solution in hexane shows an absorption maximum at approximately 470 nm Test for carotenoids 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 Solubility Insoluble in water, freely soluble in chloroform Properties of 1 % solution in chloroform Is clear and has intensive red-orange colour Purity Loss on drying Not more than 0,5 % (40 °C, 4 h at 20 mm Hg) Apo-12’-lycopenal Not more than 0,15 % Triphenyl phosphine oxide Not more than 0,01 % Solvent residues 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 preparations only) Lead Not more than 1 mg/kg

(ii) LYCOPENE FROM RED TOMATOES







Synonyms Natural Yellow 27 Definition Lycopene is obtained by solvent extraction of red tomatoes (Lycopersicon 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. Colour Index No 75125 Einecs 207-949-1 Chemical name Ψ,Ψ-carotene, all-trans-lycopene, (all-E)-lycopene, (all-E)-2,6,10,14,19,23,27,31-octamethyl-2,6,8,10,12,14,16,18,20,22,24,26,30-dotriacontatridecaene Chemical formula C40H56 Molecular weight 536,85 Assay at 465-475 nm in hexane (for 100 % pure all- trans -lycopene) is 3 450. Content not less than 5 % total colouring matters Description Dark red viscous liquid Identification Spectrophotometry Maximum in hexane at ca. 472 nm Purity Solvent residues Propan-2-ol Not more than 50 mg/kg, singly or in combination Hexane Acetone Ethanol Methanol Ethylacetate Sulphated ash Not more than 1 % Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg

(iii) LYCOPENE FROM BLAKESLEA TRISPORA







Synonyms Natural Yellow 27 Definition 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 carotenoids. 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. Colour Index No 75125 Einecs 207-949-1 Chemical name Ψ,Ψ-carotene, all-trans-lycopene, (all-E)-lycopene, ((all-E)-2,6,10,14,19,23,27,31-octamethyl-2,6,8,10,12,14,16,18,20,22,24,26,30-dotriacontatridecaene Chemical formula C40H56 Molecular weight 536,85 Assay Not less than 95 % total lycopenes and not less than 90 % all-trans-lycopene of all colouring matters at 465-475 nm in hexane (for 100 % pure all- trans -lycopene) is 3 450 Description Red crystalline powder Identification Spectrophotometry A solution in hexane shows an absorption maximum at approximately 470 nm Test of carotenoids 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 Solubility Insoluble in water, freely soluble in chloroform Properties of 1 % solution in chloroform Is clear and has intensive red-orange colour Purity Loss on drying Not more than 0,5 % (40 °C, 4 h at 20 mm Hg) Other carotenoids Not more than 5 % Solvent residues Propan-2-ol: not more than 0,1 % Isobutyl acetate: not more than 1,0 % Dichloromethane: not more than 10 mg/kg (in commercial preparations only) Sulphated ash Not more than 0,3 % Lead Not more than 1 mg/kg

E 160 e BETA-APO-8′-CAROTENAL (C30)







Synonyms CI Food Orange 6 Definition These specifications apply predominantly to the all-trans isomer of β-apo-8′-carotenal together with minor amounts of other carotenoids. Diluted and stabilised forms are prepared from β-apo-8′-carotenal meeting these specifications and include solutions or suspensions of ß-apo-8′carotenal in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios. Colour Index No 40820 Einecs 214-171-6 Chemical name β-Apo-8′-carotenal; trans-β-Apo-8′carotene-aldehyde Chemical formula C30H40O Molecular weight 416,65 Assay Not less than 96 % of total colouring matters 2 640 at 460-462 nm in cyclohexane Description Dark violet crystals with metallic lustre or crystalline powder Identification Spectrometry Maximum in cyclohexane at 460-462 nm Purity Sulphated ash Not more than 0,1 % Subsidiary colouring matters Carotenoids other than β-apo-8′-carotenal: not more than 3,0 % of total colouring matters Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

E 161 b LUTEIN







Synonyms Mixed Carotenoids; Xanthophylls Definition 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 204-840-0 Chemical name 3,3′-dihydroxy-d-carotene Chemical formula C40H56O2 Molecular weight 568,88 Assay Content of total colouring matter not less than 4 % calculated as lutein 2 550 at ca. 445 nm in chloroform/ethanol (10 + 90) or in hexane/ethanol/acetone (80 + 10 + 10) Description Dark, yellowish brown liquid Identification Spectrometry Maximum in chloroform/ethanol (1:9) at ca. 445 nm Purity Solvent residues Acetone Not more than 50 mg/kg, singly or in combination Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane Arsenic Not more than 3 mg/kg Lead Not more than 3 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

E 161g CANTHAXANTHIN







Synonyms CI Food Orange 8 Definition 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. Colour Index No 40850 Einecs 208-187-2 Chemical name β-Carotene-4,4′-dione; canthaxanthin; 4,4′-dioxo-β-carotene Chemical formula C40H52O2 Molecular weight 564,86 Assay Not less than 96 % of total colouring matters (expressed as canthaxanthin) 2 200 at ca. 485 nm in chloroform at 468-472 nm in cyclohexane at 464-467 nm in petroleum ether Description Deep violet crystals or crystalline powder 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 Not more than 0,1 % Subsidiary colouring matters Carotenoids other than canthaxanthin: not more than 5,0 % of total colouring matters Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

E 162 BEETROOT RED, BETANIN







Synonyms Beet Red Definition 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 231-628-5 Chemical name (S-(R′,R′)-4-(2-(2-Carboxy-5(β-D-glucopyranosyloxy)-2,3-dihydro-6-hydroxy-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-β-D-glucopyranosyloxy)-6-hydroxyindolium-2-carboxylate Chemical formula Betanin: C24H26N2O13 Molecular weight 550,48 Assay Content of red colour (expressed as betanine) is not less than 0,4 % 1 120 at ca. 535 nm in aqueous solution at pH 5 Description Red or dark red liquid, paste, powder or solid Identification Spectrometry Maximum in water of pH 5 at ca. 535 nm Purity Nitrate Not more than 2 g nitrate anion/g of red colour (as calculated from assay). Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

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 transformed into powder by an industrial drying process. Anthocyanins contain common components of the source material, namely anthocyanine, 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 (delphinidin); 211-403-8 (malvidin); 205-127-7 (pelargonidin); 215-849-4 (petunidin) Chemical name 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) 3,3′4′,5,7-Pentahydroxy-5′-methoxyflavylium chloride (petunidin) 3,5,7-Trihydroxy-2-(4-hydroxyphenyl)-1-benzopyrilium chloride (pelargonidin) Chemical formula Cyanidin: C15H11O6Cl Peonidin: C16H13O6Cl Malvidin: C17H15O7Cl Delphinidin: C15H11O7Cl 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 300 for the pure pigment at 515-535 nm at pH 3,0 Description 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 Not more than 50 mg/kg Ethanol Not more than 200 mg/kg Sulfur dioxide Not more than 1 000 mg/kg per percent pigment Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 170 CALCIUM CARBONATE







Synonyms CI Pigment White 18; Chalk Definition Calcium carbonate is the product obtained from ground limestone or by the precipitation of calcium ions with carbonate ions. Colour Index No 77220 Einecs Calcium carbonate: 207-439-9 Limestone: 215-279-6 Chemical name Calcium carbonate Chemical formula CaCO3 Molecular weight 100,1 Assay Content not less than 98 % on the anhydrous basis Description White crystalline or amorphous, odourless and tasteless powder Identification Solubility Practically insoluble in water and in alcohol. Dissolves with effervescence 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 Not more than 2,0 % (200 °C, 4 hours) Acid-insoluble substances Not more than 0,2 % Magnesium and alkali salts Not more than 1 % Fluoride Not more than 50 mg/kg Antimony (as Sb) Not more than 100 mg/kg, singly or in combination Copper (as Cu) Chromium (as Cr) Zinc (as Zn) Barium (as Ba) Arsenic Not more than 3 mg/kg Lead Not more than 3 mg/kg Cadmium Not more than 1 mg/kg

E 171 TITANIUM DIOXIDE







Synonyms CI Pigment White 6 Definition 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 77891 Einecs 236-675-5 Chemical name Titanium dioxide Chemical formula TiO2 Molecular weight 79,88 Assay Content not less than 99 % on an alumina and silica-free basis Description White to slightly coloured powder Identification Solubility Insoluble in water and organic solvents. Dissolves slowly in hydrofluoric acid and in hot concentrated sulphuric acid. Purity Loss on drying Not more than 0,5 % (105 °C, 3 hours) Loss on ignition Not more than 1,0 % on a volatile matter free basis (800 °C) Aluminium oxide and/or silicon dioxide 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. Water soluble matter Not more than 0,5 % Cadmium Not more than 1 mg/kg after an extraction with 0,5 N HCl. Antimony Not more than 2 mg/kg after an extraction with 0,5 N HCl. Arsenic Not more than 1 mg/kg after an extraction with 0,5 N HCl. Lead Not more than 10 mg/kg after an extraction with 0,5 N HCl. Mercury 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 manufacturing process. Colour Index No Iron Oxide Yellow: 77492 Iron Oxide Red: 77491 Iron Oxide Black: 77499 Einecs Iron Oxide Yellow: 257-098-5 Iron Oxide Red: 215-168-2 Iron Oxide Black: 235-442-5 Chemical name 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: FeO(OH) · H2O Iron Oxide Red: Fe2O3 Iron Oxide Black: FeO.Fe2O3 Molecular weight 88,85: FeO(OH) 159,70: Fe2O3 231,55: FeO.Fe2O3 Assay Yellow not less than 60 %, red and black not less than 68 % total iron, expressed as iron Description Powder; yellow, red, brown or black in hue Identification Solubility Insoluble in water and in organic solvents Soluble in concentrated mineral acids Purity Water soluble matter Not more than 1,0 % By total dissolution Arsenic Not more than 3 mg/kg Cadmium Not more than 1 mg/kg Chromium Not more than 100 mg/kg Copper Not more than 50 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/kg Nickel Not more than 200 mg/kg Zinc Not more than 100 mg/kg

E 173 ALUMINIUM







Synonyms CI Pigment Metal Definition 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. Colour Index No 77000 Einecs 231-072-3 Chemical name Aluminium Chemical formula Al Atomic weight 26,98 Assay Not less than 99 % calculated as Al on an oil-free basis Description A silvery-grey powder or tiny sheets Identification Solubility Insoluble in water and in organic solvents. Soluble in dilute hydrochloric acid. Test for aluminium A sample dissolved in dilute hydrochloric acid passes test Purity Loss on drying Not more than 0,5 % (105 °C, to constant weight) Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

E 174 SILVER







Synonyms Argentum Definition Colour Index No 77820 Einecs 231-131-3 Chemical name Silver Chemical formula Ag Atomic weight 107,87 Assay Content not less than 99,5 % Ag Description Silver-coloured powder or tiny sheets Identification Purity

E 175 GOLD







Synonyms Pigment Metal 3; Aurum Definition Colour Index No 77480 Einecs 231-165-9 Chemical name Gold Chemical formula Au Atomic weight 197,0 Assay Content not less than 90 % Au Description Gold-coloured powder or tiny sheets Identification Purity Silver Not more than 7 % After complete dissolution Copper Not more than 4 %

E 180 LITHOLRUBINE BK







Synonyms CI Pigment Red 57; Rubinpigment; Carmine 6B Definition Lithol Rubine BK consists essentially of calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalenecarboxylate and subsidiary colouring matters together with water, calcium chloride and/or calcium sulphate as the principal uncoloured components. Colour Index No 15850:1 Einecs 226-109-5 Chemical name Calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalene-carboxylate Chemical formula C18H12CaN2O6S Molecular weight 424,45 Assay Content not less than 90 % total colouring matters 200 at ca. 442 nm in dimethylformamide Description Red powder Identification Spectrometry Maximum in dimethylformamide at ca. 442 nm Purity Subsidiary colouring matters Not more than 0,5 % Organic compounds other than colouring matters: 2-Amino-5-methylbenzenesulfonic acid, calcium salt Not more than 0,2 % 3-hydroxy-2-naphthalenecarboxylic acid, calcium salt Not more than 0,4 % Unsulfonated primary aromatic amines Not more than 0,01 % (expressed as aniline) Ether extractable matter From a solution of pH 7, not more than 0,2 % Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 200 SORBIC ACID







Synonyms Definition Einecs 203-768-7 Chemical name Sorbic acid; trans, trans-2,4-Hexadienoic acid Chemical formula C6H8O2 Molecular weight 112,12 Assay Content not less than 99 % on the anhydrous basis Description Colourless needles or white free flowing powder, having a slight characteristic 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 Spectrometry A propan-2-ol solution (1 in 4 000 000) shows absorbance maximum at 254 ± 2 nm Test for double bonds Passes test Solubility Slightly soluble in water, soluble in ethanol. Purity Water content Not more than 0,5 % (Karl Fischer method) Sulphated ash Not more than 0,2 % Aldehydes Not more than 0,1 % (as formaldehyde) Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg

E 202 POTASSIUM SORBATE







Synonyms Definition Einecs 246-376-1 Chemical name Potassium sorbate; Potassium (E,E)-2,4-hexadienoate; Potassium salt of trans, trans 2,4-hexadienoic acid Chemical formula C6H7O2K Molecular weight 150,22 Assay Content not less than 99 % on the dried basis Description White crystalline powder showing no change in colour after heating for 90 minutes at 105 °C 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 Test for potassium Passes test Test for double bonds Passes test Purity Loss on drying Not more than 1,0 % (105 °C, 3 hours) Acidity or alkalinity Not more than about 1,0 % (as sorbic acid or K2CO3) Aldehydes Not more than 0,1 %, calculated as formaldehyde Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg

E 203 CALCIUM SORBATE







Synonyms Definition Einecs 231-321-6 Chemical name Calcium sorbate; Calcium salts of trans, trans-2,4-hexadienoic acid Chemical formula C12H14O4Ca Molecular weight 262,32 Assay Content not less than 98 % on the dried basis 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 Test for calcium Passes test Test for double bonds Passes test Purity Loss on drying Not more than 2,0 %, determined by vacuum drying for four hours in a sulphuric acid desiccator Aldehydes Not more than 0,1 % (as formaldehyde) Fluoride Not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg

E 210 BENZOIC ACID







Synonyms Definition Einecs 200-618-2 Chemical name Benzoic acid; Benzenecarboxylic acid; Phenylcarboxylic acid Chemical formula C7H6O2 Molecular weight 122,12 Assay Content not less than 99,5 % on the anhydrous basis Description White crystalline powder Identification Melting range 121,5 °C -123,5 °C Sublimation test Passes test Test for benzoate Passes test pH About 4 (solution in water) Purity Loss on drying Not more than 0,5 % (3 hours, over sulphuric acid) Sulphated ash Not more than 0,05 % Chlorinated organic compounds Not more than 0,07 % expressed as chloride corresponding to 0,3 % expressed as monochlorobenzoic acid Readily oxidisable substances 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