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Document 32012R0231

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 83, 22.3.2012, p. 1–295 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

This document has been published in a special edition(s) (HR)

Legal status of the document In force: This act has been changed. Current consolidated version: 27/10/2024

ELI: http://data.europa.eu/eli/reg/2012/231/oj

22.3.2012   

EN

Official Journal of the European Union

L 83/1


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 As a consequence, those Directives should be repealed.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,

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.

Done at Brussels, 9 March 2012.

For the Commission

The President

José Manuel BARROSO


(1)   OJ L 354, 31.12.2008, p. 16.

(2)   OJ L 354, 31.12.2008, p. 1.

(3)   OJ L 6, 10.1.2009, p. 20.

(4)   OJ L 253, 20.9.2008, p. 1.

(5)   OJ L 158, 18.6.2008, p. 17.

(6)  EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the use of Basic Methacrylate Copolymer as a food additive on request from the European Commission. EFSA Journal 2010; 8(2):1513.

(7)  EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the safety of sucrose esters of fatty acids prepared from vinyl esters of fatty acids and on the extension of use of sucrose esters of fatty acids in flavourings on request from the European Commission. EFSA Journal 2010; 8(3):1512.

(8)  EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on Arsenic in Food. EFSA Journal 2009; 7(10):1351.

(9)   OJ L 61, 18.3.1995, p. 1.

(10)  EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the re-evaluation of curcumin (E 100) as a food additive. EFSA Journal 2010; 8(9):1679.

(11)  As defined in Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (codified version), OJ L 339, 6.12.2006, p. 16.

(12)  Opinion on Additives in nutrient preparations for use in infant formulae, follow-on formulae and weaning foods. Reports of the Scientific Committee on food (40th Series), p. 13-30, (1997).

(13)  Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Food Contact Materials on a request from European Commission on Safety of aluminium from dietary intake. EFSA Journal (2008) 754, 1-34.

(14)   OJ L 80, 26.3.2010, p. 28.

(15)   OJ L 364, 20.12.2006, p. 5.

(16)  WHO Technical Report Series, No 956, 2010.

(17)  EP 7.0 volume 2, p. 2415-2416.

(18)  EFSA Panel on Food Additives and Nutrient Sources (ANS); Scientific Opinion on the safety of steviol glycosides for the proposed uses as a food additive. EFSA Journal (2010); 8(4):1537.


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

Formula
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

Formula
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

Formula
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

Formula
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

Formula
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

Formula
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

Formula
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

Formula
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

Formula
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.

Formula
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

Formula
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

Formula
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

Formula
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 %

Formula
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

Formula
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 %

Formula
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.

Formula
700 at ca. 405 nm in aqueous solution at pH 9

Formula
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 %.

Formula
540 at ca. 422 nm in chloroform

Formula
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.

Formula
565 at ca. 405 nm in aqueous phosphate buffer at pH 7,5

Formula
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

Formula
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

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 (2)

0,05-0,13

Total nitrogen

Not more than 0,3 % (3)

Sulphur dioxide

Not more than 0,2 % (3)

Total sulphur

0,3-3,5 % (3)

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

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 (4)

0,08-0,36

Ammoniacal nitrogen

Not more than 0,3 % (5)

4-methylimidazole

Not more than 200 mg/kg (5)

2-acetyl-4-tetrahydroxy-butylimidazole

Not more than 10 mg/kg (5)

Total sulphur

Not more than 0,2 % (5)

Total nitrogen

0,7-3,3 % (5)

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

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 (6)

0,10-0,60

Ammoniacal nitrogen

Not more than 0,6 % (7)

Sulphur dioxide

Not more than 0,2 % (7)

4-methylimidazole

Not more than 250 mg/kg (7)

Total nitrogen

0,3-1,7 % (7)

Total sulphur

0,8-2,5 % (7)

Nitrogen/sulphur ratio of alcohol precipitate

0,7-2,7

Absorbance ratio of alcohol precipitate (8)

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

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

Formula
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.

Formula
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)

Formula
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 (9), 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

Formula
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

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)

Formula
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 %

Formula
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:

Formula

2 870 at ca. 502 nm in chloroform

Norbixin:

Formula

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:

Formula

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:

Formula

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

Formula
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)

Formula
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

Formula
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

Formula
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

Formula
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

Formula
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)

Formula

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 %

Formula
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

Formula

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

Formula
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 0,5 ml should be required

Readily carbonisable substances

A cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC (10), 0,3 ml of ferric chloride TSC (11), 0,1 ml of copper sulphate TSC (12) and 4,4 ml of water

Polycyclic acids

On fractional acidification of a neutralised solution of benzoic acid, the first precipitate must not have a different melting point from that of the benzoic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 211 SODIUM BENZOATE

Synonyms

 

Definition

Einecs

208-534-8

Chemical name

Sodium benzoate; Sodium salt of benzenecarboxylic acid; Sodium salt of phenylcarboxylic acid

Chemical formula

C7H5O2Na

Molecular weight

144,11

Assay

Not less than 99 % of C7H5O2Na, after drying at 105 °C for four hours

Description

A white, almost odourless, crystalline powder or granules

Identification

Solubility

Freely soluble in water, sparingly soluble in ethanol

Melting range for benzoic acid

Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 °C to 123,5 °C, after drying in a sulphuric acid desiccator

Test for benzoate

Passes test

Test for sodium

Passes test

Purity

Loss on drying

Not more than 1,5 % (105 °C, 4 hours)

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 0,5 ml should be required

Polycyclic acids

On fractional acidification of a (neutralised) solution of sodium benzoate, the first precipitate must not have a different melting range from that of benzoic acid

Chlorinated organic compounds

Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid

Acidity or alkalinity

Neutralisation of 1 g of sodium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 212 POTASSIUM BENZOATE

Synonyms

 

Definition

Einecs

209-481-3

Chemical name

Potassium benzoate; Potassium salt of benzenecarboxylic acid; Potassium salt of phenylcarboxylic acid

Chemical formula

C7H5KO2·3H2O

Molecular weight

214,27

Assay

Content not less than 99 % C7H5KO2 after drying at 105 °C to constant weight

Description

White crystalline powder

Identification

Melting range for benzoic acid

Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator

Test for benzoate

Passes test

Test for potassium

Passes test

Purity

Loss on drying

Not more than 26,5 % (105 °C, 4 hours)

Chlorinated organic compounds

Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid

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 0,5 ml should be required

Readily carbonisable substances

A cold solution of 0,5 g of benzoic acid in 5 ml 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water

Polycyclic acids

On fractional acidification of a (neutralised) solution of potassium benzoate, the first precipitate must not have a different melting range from that of benzoic acid

Acidity or alkalinity

Neutralisation of 1 g of potassium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 213 CALCIUM BENZOATE

Synonyms

Monocalcium benzoate

Definition

Einecs

218-235-4

Chemical name

Calcium benzoate; Calcium dibenzoate

Chemical formula

Anhydrous:

C14H10O4Ca

Monohydrate:

C14H10O4Ca·H2O

Trihydrate:

C14H10O4Ca·3H2O

Molecular weight

Anhydrous:

282,31

Monohydrate:

300,32

Trihydrate:

336,36

Assay

Content not less than 99 % after drying at 105 °C

Description

White or colourless crystals, or white powder

Identification

Melting range for benzoic acid

Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator

Test for benzoate

Passes test

Test for calcium

Passes test

Purity

Loss on drying

Not more than 17,5 % (105 °C, to constant weight)

Water insoluble matter

Not more than 0,3 %

Chlorinated organic compounds

Not more than 0,06 % expressed as chloride, corresponding to 0,25 % 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 0,5 ml should be required

Readily carbonisable substances

Cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water

Polycyclic acids

On fractional acidification of a (neutralised) solution of calcium benzoate, the first precipitate must not be a different melting range from that of benzoic acid

Acidity or alkalinity

Neutralisation of 1 g of calcium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl

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 214 ETHYL p-HYDROXYBENZOATE

Synonyms

Ethylparaben; Ethyl p-oxybenzoate

Definition

Einecs

204-399-4

Chemical name

Ethyl-p-hydroxybenzoate; Ethyl ester of p-hydroxybenzoic acid

Chemical formula

C9H10O3

Molecular weight

166,8

Assay

Content not less than 99,5 % after drying for two hours at 80 °C

Description

Almost odourless, small, colourless crystals or a white, crystalline powder

Identification

Melting range

115-118 °C

Test for p-hydroxybenzoate

Melting range of p-hydroxybenzoic acid isolated by acidification and not recrystallised: 213 °C to 217 °C, after vacuum drying in a sulphuric acid desiccator

Test for alcohol

Passes test

Purity

Loss on drying

Not more than 0,5 % (80 °C, 2 hours)

Sulphated ash

Not more than 0,05 %

p-Hydroxybenzoic acid and salicylic acid

Not more than 0,35 % expressed as p-hydroxybenzoic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 215 SODIUM ETHYL p-HYDROXYBENZOATE

Synonyms

 

Definition

Einecs

252-487-6

Chemical name

Sodium ethyl p-hydroxybenzoate; Sodium compound of the ethyl ester of p-hydroxybenzoic acid

Chemical formula

C9H9O3Na

Molecular weight

188,8

Assay

Content of ethylester of p-hydroxybenzoic acid not less than 83 % on the anhydrous basis

Description

White, crystalline hygroscopic powder

Identification

Melting range

115 °C to 118 °C, after vacuum drying in a sulphuric acid desiccator

Test for p-hydroxybenzoate

Melting range of p-hydroxybenzoic acid derived from the sample is 213 °C to 217 °C

Test for sodium

Passes test

pH

9,9-10,3 (0,1 % aqueous solution)

Purity

Loss on drying

Not more than 5 %, (by vacuum drying in a sulphuric acid desiccator)

Sulphated ash

37 to 39 %

p-Hydroxybenzoic acid and salicylic acid

Not more than 0,35 % expressed as p-hydroxybenzoic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 218 METHYL p-HYDROXYBENZOATE

Synonyms

Methylparaben; Methyl-p-oxybenzoate

Definition

Einecs

243-171-5

Chemical name

Methyl p-hydroxybenzoate; Methyl ester of p-hydroxybenzoic acid

Chemical formula

C8H8O3

Molecular weight

152,15

Assay

Content not less than 99 % after drying for two hours at 80 °C

Description

Almost odourless, small colourless crystals or white crystalline powder

Identification

Melting range

125 °C - 128 °C

Test for p-hydroxybenzoate

Melting range of p-hydroxybenzoic acid derived from the sample is 213 °C to 217 °C after drying for two hours at 80 °C

Purity

Loss on drying

Not more than 0,5 % (80 °C, 2 hours)

Sulphated ash

Not more than 0,05 %

p-Hydroxybenzoic acid and salicylic acid

Not more than 0,35 % expressed as p-hydroxybenzoic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 219 SODIUM METHYL p-HYDROXYBENZOATE

Synonyms

 

Definition

Einecs

 

Chemical name

Sodium methyl p-hydroxybenzoate; Sodium compound of the methylester of p-hydroxybenzoic acid

Chemical formula

C8H7O3Na

Molecular weight

174,15

Assay

Content not less than 99,5 % on the anhydrous basis

Description

White, hygroscopic powder

Identification

Melting range

The white precipitate formed by acidifying with hydrochloric acid a 10 % (w/v) aqueous solution of the sodium derivative of methyl p-hydroxybenzoate (using litmus paper as indicator) shall, when washed with water and dried at 80 °C for two hours, have a melting range of 125 °C to 128 °C

Test for sodium

Passes test

pH

9,7-10,3 (0,1 % solution in carbon dioxide free water)

Purity

Water content

Not more than 5 % (Karl Fischer method)

Sulphated ash

40 % to 44,5 % on the anhydrous basis

p-Hydroxybenzoic acid and salicylic acid

Not more than 0,35 % expressed as p-hydroxybenzoic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 220 SULPHUR DIOXIDE

Synonyms

 

Definition

Einecs

231-195-2

Chemical name

Sulphur dioxide; Sulphurous acid anhydride

Chemical formula

SO2

Molecular weight

64,07

Assay

Content not less than 99 %

Description

Colourless, non-flammable gas with strong pungent suffocating odour

Identification

Test for sulphurous substances

Passes test

Purity

Water content

Not more than 0,05 % (Karl Fischer method)

Non-volatile residue

Not more than 0,01 %

Sulphur trioxide

Not more than 0,1 %

Selenium

Not more than 10 mg/kg

Other gases not normally present in the air

No trace

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 221 SODIUM SULPHITE

Synonyms

 

Definition

Einecs

231-821-4

Chemical name

Sodium sulphite (anhydrous or heptahydrate)

Chemical formula

Anhydrous:

Na2SO3

Heptahydrate:

Na2SO37H2O