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Title and reference
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)
Special edition in Croatian: Chapter 13 Volume 037 P. 3 - 297

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

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 As a consequence, those Directives should be repealed.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

Formula1 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

Formula1 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

Formula2 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

Formula1 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

Formula1 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)

Formula2 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

Formula2 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)

Formula2 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 %

Formula2 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

Formula2 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

Formula2 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

Formula2 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 %

Formula1 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

Molecular weight

Anhydrous:

126,04

Heptahydrate:

252,16

Assay

Anhydrous:

Not less than 95 % of Na2SO3 and not less than 48 % of SO2

Heptahydrate:

Not less than 48 % of Na2SO3 and not less than 24 % of SO2

Description

White crystalline powder or colourless crystals

Identification

Test for sulphite

Passes test

Test for sodium

Passes test

pH

8,5-11,5 (anhydrous: 10 % solution; heptahydrate: 20 % solution)

Purity

Thiosulphate

Not more than 0,1 % based on the SO2 content

Iron

Not more than 10 mg/kg based on the SO2 content

Selenium

Not more than 5 mg/kg based on the SO2 content

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 222 SODIUM BISULPHITE

Synonyms

 

Definition

Einecs

231-921-4

Chemical name

Sodium bisulphite; Sodium hydrogen sulphite

Chemical formula

NaHSO3 in aqueous solution

Molecular weight

104,06

Assay

Content not less than 32 % w/w NaHSO3

Description

A clear, colourless to yellow solution

Identification

Test for sulphite

Passes test

Test for sodium

Passes test

pH

2,5-5,5 (10 % aqueous solution)

Purity

Iron

Not more than 10 mg/kg of Na2SO3 based on the SO2 content

Selenium

Not more than 5 mg/kg based on the SO2 content

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 223 SODIUM METABISULPHITE

Synonyms

Pyrosulphite; Sodium pyrosulphite

Definition

Einecs

231-673-0

Chemical name

Sodium disulphite; Disodium pentaoxodisulphate

Chemical formula

Na2S2O5

Molecular weight

190,11

Assay

Content not less than 95 % Na2S2O5 and not less than 64 % of SO2

Description

White crystals or crystalline powder

Identification

Test for sulphite

Passes test

Test for sodium

Passes test

pH

4,0-5,5 (10 % aqueous solution)

Purity

Thiosulphate

Not more than 0,1 % based on the SO2 content

Iron

Not more than 10 mg/kg based on the SO2 content

Selenium

Not more than 5 mg/kg based on the SO2 content

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 224 POTASSIUM METABISULPHITE

Synonyms

Potassium pyrosulphite

Definition

Einecs

240-795-3

Chemical name

Potassium disulphite; Potassium pentaoxo disulphate

Chemical formula

K2S2O5

Molecular weight

222,33

Assay

Content not less than 90 % K2S2O5 and not less than 51,8 % of SO2, the remainder being composed almost entirely of potassium sulphate

Description

Colourless crystals or white crystalline powder

Identification

Test for sulphite

Passes test

Test for potassium

Passes test

Purity

Thiosulphate

Not more than 0,1 % based on the SO2 content

Iron

Not more than 10 mg/kg based on the SO2 content

Selenium

Not more than 5 mg/kg based on the SO2 content

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 226 CALCIUM SULPHITE

Synonyms

 

Definition

Einecs

218-235-4

Chemical name

Calcium sulphite

Chemical formula

CaSO3·2H2O

Molecular weight

156,17

Assay

Content not less than 95 % of CaSO3·2H2O and not less than 39 % of SO2

Description

White crystals or white crystalline powder

Identification

Test for sulphite

Passes test

Test for calcium

Passes test

Purity

Iron

Not more than 10 mg/kg based on the SO2 content

Selenium

Not more than 5 mg/kg based on the SO2 content

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 227 CALCIUM BISULPHITE

Synonyms

 

Definition

Einecs

237-423-7

Chemical name

Calcium bisulphite; Calcium hydrogen sulphite

Chemical formula

Ca(HSO3)2

Molecular weight

202,22

Assay

6 to 8 % (w/v) of sulphur dioxide and 2,5 to 3,5 % (w/v) of calcium dioxide corresponding to 10 to 14 % (w/v) of calcium bisulphite [Ca(HSO3)2]

Description

Clear greenish-yellow aqueous solution having a distinct odour of sulphur dioxide

Identification

Test for sulphite

Passes test

Test for calcium

Passes test

Purity

Iron

Not more than 10 mg/kg based on the SO2 content

Selenium

Not more than 5 mg/kg based on the SO2 content

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 228 POTASSIUM BISULPHITE

Synonyms

 

Definition

Einecs

231-870-1

Chemical name

Potassium bisulphite; Potassium hydrogen sulphite

Chemical formula

KHSO3 in aqueous solution

Molecular weight

120,17

Assay

Content not less than 280 g KHSO3 per litre (or 150 g SO2 per litre)

Description

Clear colourless aqueous solution

Identification

Test for sulphite

Passes test

Test for potassium

Passes test

Purity

Iron

Not more than 10 mg/kg based on the SO2 content

Selenium

Not more than 5 mg/kg based on the SO2 content

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 234 NISIN

Synonyms

 

Definition

Nisin consists of several closely related polypeptides produced by strains of Lactococcus lactis subsp. lactis

Einecs

215-807-5

Chemical name

 

Chemical formula

C143H230N42O37S7

Molecular weight

3 354,12

Assay

Nisin concentrate contains not less than 900 units per mg in a mixture of non-fat milk solids and a minimum sodium chloride content of 50 %

Description

White powder

Identification

 

Purity

Loss on drying

Not more than 3 % (102 °C to 103 °C, to constant weight)

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

E 235 NATAMYCIN

Synonyms

Pimaricin

Definition

Natamycin is a fungicide of the polyene macrolide group, and is produced by strains of Streptomyces natalensis and other relevant species

Einecs

231-683-5

Chemical name

A stereoisomer of 22-(3-Amino-3,6-dideoxy-β-D- mannopyranosyloxy)-1,3,26-trihydroxy-12-methyl-10-oxo-6,11,28-trioxatricyclo[22.3.1.05,7]octacosa-8,14,16,18,20-pentaene-25-carboxylic acid.

Chemical formula

C33H47O13N

Molecular weight

665,74

Assay

Content not less than 95 % on the dried basis

Description

White to creamy-white crystalline powder

Identification

Colour reactions

On adding a few crystals of natamycin on a spot plate, to a drop of:

 

concentrated hydrochloric acid, a blue colour develops,

 

concentrated phosphoric acid, a green colour develops,which changes into pale red after a few minutes

Spectrometry

A 0,0005 % w/v solution in 1 % methanolic acetic acid solution has absorption maxima at about 290 nm, 303 nm and 318 nm, a shoulder at about 280 nm and exhibits minima at about 250 nm, 295,5 nm and 311 nm

pH

5,5-7,5 (1 % w/v solution in previously neutralised mixture of 20 parts dimethylformamide and 80 parts of water)

Specific rotation

[α]D 20 + 250° to + 295° (a 1 % w/v solution in glacial acetic acid, at 20 °C and calculated with reference to the dried material)

Purity

Loss on drying

Not more than 8 % (over P2O5, in vacuum at 60 °C to constant weight)

Sulphated ash

Not more than 0,5 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

Microbiological criteria

Total plate count

Not more than 100 colonies per gram

E 239 HEXAMETHYLENE TETRAMINE

Synonyms

Hexamine; Methenamine

Definition

Einecs

202-905-8

Chemical name

1,3,5,7-Tetraazatricyclo [3.3.1.13,7]-decane, hexamethylenetetramine

Chemical formula

C6H12N4

Molecular weight

140,19

Assay

Content not less than 99 % on the anhydrous basis

Description

Colourless or white crystalline powder

Identification

Test for formaldehyde

Passes test

Test for ammonia

Passes test

Sublimation point:

Approximately 260 °C

Purity

Loss on drying

Not more than 0,5 % (at 105 °C in vacuum over P2O5 for 2 hours)

Sulphated ash

Not more than 0,05 %

Sulphates

Not more than 0,005 % expressed as SO4

Chlorides

Not more than 0,005 % expressed as Cl

Ammonium salts

Not detectable

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 242 DIMETHYL DICARBONATE

Synonyms

DMDC; Dimethyl pyrocarbonate

Definition

Einecs

224-859-8

Chemical name

Dimethyl dicarbonate; Pyrocarbonic acid dimethyl ester

Chemical formula

C4H6O5

Molecular weight

134,09

Assay

Content not less than 99,8 %

Description

Colourless liquid, decomposes in aqueous solution. It is corrosive to skin and eyes and toxic by inhalation and ingestion

Identification

Decomposition

After dilution positive tests for CO2 and methanol

Melting point

17 °C

Boiling point

172 °C with decomposition

Density 20 °C

Approximately 1,25 g/cm3

Infrared absorption spectrum

Maxima at 1 156 and 1 832 cm-1

Purity

Dimethyl carbonate

Not more than 0,2 %

Chlorine, total

Not more than 3 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 249 POTASSIUM NITRITE

Synonyms

 

Definition

Einecs

231-832-4

Chemical name

Potassium nitrite

Chemical formula

KNO2

Molecular weight

85,11

Assay

Content not less than 95 % on the anhydrous basis (14)

Description

White or slightly yellow, deliquescent granules

Identification

Test for nitrite

Passes test

Test for potassium

Passes test

pH

6,0-9,0 (5 % solution)

Purity

Loss on drying

Not more than 3 % (4 hours, over silica gel)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 250 SODIUM NITRITE

Synonyms

 

Definition

Einecs

231-555-9

Chemical name

Sodium nitrite

Chemical formula

NaNO2

Molecular weight

69,00

Assay

Content not less than 97 % on the anhydrous basis (15)

Description

White crystalline powder or yellowish lumps

Identification

Test for nitrite

Passes test

Test for sodium

Passes test

Purity

Loss on drying

Not more than 0,25 % (4 hours, over silica gel)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 251 SODIUM NITRATE

(i)   SOLID SODIUM NITRATE

Synonyms

Chile saltpetre; Cubic or soda nitre

Definition

Einecs

231-554-3

Chemical name

Sodium nitrate

Chemical formula

NaNO3

Molecular weight

85,00

Assay

Content not less than 99 % on the anhydrous basis

Description

White crystalline, slightly hygroscopic powder

Identification

Test for nitrate

Passes test

Test for sodium

Passes test

pH

5,5-8,3 (5 % solution)

Purity

Loss on drying

Not more than 2 % (105 °C, 4 hours)

Nitrites

Not more than 30 mg/kg expressed as NaNO2

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

(ii)

LIQUID SODIUM NITRATE

Synonyms

 

Definition

Liquid sodium nitrate is an aqueous solution of sodium nitrate as the direct result of the chemical reaction between sodium hydroxide and nitric acid in stoechiometric amounts, without subsequent crystallisation. Standardised forms prepared from liquid sodium nitrate meeting these specifications may contain nitric acid in excessive amounts, if clearly stated or labelled.

Einecs

231-554-3

Chemical name

Sodium nitrate

Chemical formula

NaNO3

Molecular weight

85,00

Assay

Content between 33,5 % and 40,0 % of NaNO3

Description

Clear colourless liquid

Identification

Test for nitrate

Passes test

Test for sodium

Passes test

pH

1,5-3,5

Purity

Free nitric acid

Not more than 0,01 %

Nitrites

Not more than 10 mg/kg expressed as NaNO2

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 0,3 mg/kg

This specification refers to a 35 % aqueous solution.

E 252 POTASSIUM NITRATE

Synonyms

Chile saltpetre; Cubic or soda nitre

Definition

Einecs

231-818-8

Chemical name

Potassium nitrate

Chemical formula

KNO3

Molecular weight

101,11

Assay

Content not less than 99 % on the anhydrous basis

Description

White crystalline powder or transparent prisms having a cooling, saline, pungent taste

Identification

Test for nitrate

Passes test

Test for potassium

Passes test

pH

4,5-8,5 (5 % solution)

Purity

Loss on drying

Not more than 1 % (105 °C, 4 hours)

Nitrites

Not more than 20 mg/kg expressed as KNO2

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 260 ACETIC ACID

Synonyms

 

Definition

Einecs

200-580-7

Chemical name

Acetic acid; Ethanoic acid

Chemical formula

C2H4O2

Molecular weight

60,05

Assay

Content not less than 99,8 %

Description

Clear, colourless liquid having a pungent, characteristic odour

Identification

Boiling point

118 °C at 760 mm pressure (of mercury)

Specific gravity

About 1,049

Test for acetate

A one in three solution gives positive tests for acetate

Solidification point

Not lower than 14,5 °C

Purity

Non-volatile residue

Not more than 100 mg/kg

Formic acid, formates and other oxidisable substances

Not more than 1 000 mg/kg expressed as formic acid

Readily oxidisable substances

Dilute 2 ml of the sample in a glass-stoppered container with 10 ml of water and add 0,1 ml of 0,1 N potassium permanganate. The pink colour does not change to brown within 30 minutes

Arsenic

Not more than 1 mg/kg

Lead

Not more than 0,5 mg/kg

Mercury

Not more than 1 mg/kg

E 261 POTASSIUM ACETATE

Synonyms

 

Definition

Einecs

204-822-2

Chemical name

Potassium acetate

Chemical formula

C2H3O2K

Molecular weight

98,14

Assay

Content not less than 99 % on the anhydrous basis

Description

Colourless, deliquescent crystals or a white crystalline powder, odourless or with a faint acetic odour

Identification

pH

7,5-9,0 (5 % aqueous solution)

Test for acetate

Passes test

Test for potassium

Passes test

Purity

Loss on drying

Not more than 8 % (150 °C, 2 hours)

Formic acid, formates and other oxidisable substances

Not more than 1 000 mg/kg expressed as formic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 262 (i) SODIUM ACETATE

Synonyms

 

Definition

Einecs

204-823-8

Chemical name

Sodium acetate

Chemical formula

C2H3NaO2·nH2O (n = 0 or 3)

Molecular weight

Anhydrous:

82,03

Trihydrate:

136,08

Assay

Content (for both of anhydrous and trihydrate form) not less than 98,5 % on the anhydrous basis

Description

Anhydrous:

White, odourless, granular, hygroscopic powder

Trihydrate:

Colourless, transparent crystals or a granular crystalline powder, odourless or with a faint, acetic odour. Effloresces in warm, dry air

Identification

pH

8,0-9,5 (1 % aqueous solution)

Test for acetate

Passes test

Test for sodium

Passes test

Purity

Loss on drying

Anhydrous:

Not more than 2 % (120 °C, 4 hours)

Trihydrate:

Between 36 and 42 % (120 °C, 4 hours)

Formic acid, formates and other oxidisable substances

Not more than 1 000 mg/kg expressed as formic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 262 (ii) SODIUM DIACETATE

Synonyms

 

Definition

Sodium diacetate is a molecular compound of sodium acetate and acetic acid

Einecs

204-814-9

Chemical name

Sodium hydrogen diacetate

Chemical formula

C4H7NaO4·nH2O (n = 0 or 3)

Molecular weight

142,09 (anhydrous)

Assay

Content 39 to 41 % of free acetic acid and 58 to 60 % of sodium acetate

Description

White, hygroscopic crystalline solid with an acetic odour

Identification

pH

4,5-5,0 (10 % aqueous solution)

Test for acetate

Passes test

Test for sodium

Passes test

Purity

Water content

Not more than 2 % (Karl Fischer method)

Formic acid, formates and other oxidisable substances

Not more than 1 000 mg/kg expressed as formic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 263 CALCIUM ACETATE

Synonyms

 

Definition

Einecs

200-540-9

Chemical name

Calcium acetate

Chemical formula

Anhydrous:

C4H6O4Ca

Monohydrate:

C4H6O4Ca·H2O

Molecular weight

Anhydrous:

158,17

Monohydrate:

176,18

Assay

Content not less than 98 % on the anhydrous basis

Description

Anhydrous calcium acetate is a white, hygroscopic, bulky, crystalline solid with a slightly bitter taste. A slight odour of acetic acid may be present. The monohydrate may be needles, granules or powder

Identification

pH

6,0-9,0 (10 % aqueous solution)

Test for acetate

Passes test

Test for calcium

Passes test

Purity

Loss on drying

Not more than 11 % (155 °C to constant weight, for the monohydrate)

Water insoluble matter

Not more than 0,3 %

Formic acid, formates and other oxidisable substances

Not more than 1 000 mg/kg expressed as formic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 270 LACTIC ACID

Synonyms

 

Definition

Consists of a mixture of lactic acid (C3H6O3) and lactic acid lactate (C6H10O5). It is obtained by the lactic fermentation of sugars or is prepared synthetically.

Lactic acid is hygroscopic and when concentrated by boiling, it condenses to form lactic acid lactate, which on dilution and heating hydrolyses to lactic acid.

Einecs

200-018-0

Chemical name

Lactic acid; 2-Hydroxypropionic acid; 1-Hydroxyethane-1-carboxylic acid

Chemical formula

C3H6O3

Molecular weight

90,08

Assay

Content not less than 76 %

Description

Colourless or yellowish, nearly odourless, syrupy liquid to solid

Identification

Test for lactate

Passes test

Purity

Sulphated ash

Not more than 0,1 %

Chloride

Not more than 0,2 %

Sulphate

Not more than 0,25 %

Iron

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

Note: This specification refers to a 80 % aqueous solution; for weaker aqueous solutions, calculate values corresponding to their lactic acid content

E 280 PROPIONIC ACID

Synonyms

 

Definition

Einecs

201-176-3

Chemical name

Propionic acid; Propanoic acid

Chemical formula

C3H6O2

Molecular weight

74,08

Assay

Content not less than 99,5 %

Description

Colourless or slightly yellowish, oily liquid with a slightly pungent odour

Identification

Melting point

– 22 °C

Distillation range

138,5 °C to 142,5 °C

Purity

Non-volatile residue

Not more than 0,01 % when dried at 140 °C to constant weight

Aldehydes

Not more than 0,1 % expressed as formaldehyde

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 281 SODIUM PROPIONATE

Synonyms

 

Definition

Einecs

205-290-4

Chemical name

Sodium propionate; Sodium propanoate

Chemical formula

C3H5O2Na

Molecular weight

96,06

Assay

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

Description

White crystalline hygroscopic powder, or a fine white powder

Identification

Test for propionate

Passes test

Test for sodium

Passes test

pH

7,5-10,5 (10 % aqueous solution)

Purity

Loss on drying

Not more than 4 % (105 °C, 2 hours)

Water insoluble matter

Not more than 0,1 %

Iron

Not more than 50 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 282 CALCIUM PROPIONATE

Synonyms

 

Definition

Einecs

223-795-8

Chemical name

Calcium propionate

Chemical formula

C6H10O4Ca

Molecular weight

186,22

Assay

Content not less than 99 %, after drying for two hours at 105 °C

Description

White crystalline powder

Identification

Test for propionate

Passes test

Test for calcium

Passes test

pH

6,0-9,0 (10 % aqueous solution)

Purity

Loss on drying

Not more than 4 % (105 °C, 2 hours)

Water insoluble matter

Not more than 0,3 %

Iron

Not more than 50 mg/kg

Fluoride

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

E 283 POTASSIUM PROPIONATE

Synonyms

 

Definition

Einecs

206-323-5

Chemical name

Potassium propionate; Potassium propanoate

Chemical formula

C3H5KO2

Molecular weight

112,17

Assay

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

Description

White crystalline powder

Identification

Test for propionate

Passes test

Test for potassium

Passes test

Purity

Loss on drying

Not more than 4 % (105 °C, 2 hours)

Water insoluble matter

Not more than 0,1 %

Iron

Not more than 30 mg/kg

Fluoride

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

E 284 BORIC ACID

Synonyms

Boracic acid; Orthoboric acid; Borofax

Definition

Einecs

233-139-2

Chemical name

 

Chemical formula

H3BO3

Molecular weight

61,84

Assay

Content not less than 99,5 %

Description

Colourless, odourless, transparent crystals or white granules or powder; slightly unctuous to the touch; occurs in nature as the mineral sassolite

Identification

Melting point

At approximately 171 °C

Burning test

Burns with a nice green flame

pH

3,8-4,8 (3,3 % aqueous solution)

Purity

Peroxides

No colour develops with added KI-solution

Arsenic

Not more than 1 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 285 SODIUM TETRABORATE (BORAX)

Synonyms

Sodium borate

Definition

Einecs

215-540-4

Chemical name

Sodium tetraborate; Sodium biborate; Sodium pyroborate; Anhydrous tetraborate

Chemical formula

Na2B4O7

Na2B4O7·10H2O

Molecular weight

201,27

Assay

 

Description

Powder or glass-like plates becoming opaque on exposure to air; slowly soluble in water

Identification

Melting range

Between 171 °C and 175 °C with decomposition

Purity

Peroxides

No colour develops with added KI-solution

Arsenic

Not more than 1 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 290 CARBON DIOXIDE

Synonyms

Carbonic acid gas; Dry ice (solid form); Carbonic anhydride

Definition

Einecs

204-696-9

Chemical name

Carbon dioxide

Chemical formula

CO2

Molecular weight

44,01

Assay

Content not less than 99 % v/v on the gaseous basis

Description

A colourless gas under normal environmental conditions with a slight pungent odour. Commercial carbon dioxide is shipped and handled as a liquid in pressurised cylinders or bulk storage systems, or in compressed solid blocks of ‘dry ice’. Solid (dry ice) forms usually contain added substances, such as propylene glycol or mineral oil, as binders

Identification

Precipitate formation

When a stream of the sample is passed through a solution of barium hydroxide, a white precipitate is produced which dissolves with effervescence in dilute acetic acid

Purity

Acidity

915 ml of gas bubbled through 50 ml of freshly boiled water must not render the latter more acid to methylorange than is 50 ml freshly boiled water to which has been added 1 ml of hydrochloric acid (0,01 N)

Reducing substances, hydrogen phosphide and sulphide

915 ml of gas bubbled through 25 ml of ammoniacal silver nitrate reagent to which has been added 3 ml of ammonia must not cause clouding or blackening of this solution

Carbon monoxide

Not more than 10 μl/l

Oil content

Not more than 5 mg/kg

E 296 MALIC ACID

Synonyms

Pomalous acid

Definition

Einecs

230-022-8, 210-514-9, 202-601-5

Chemical name

hydroxybutanedioic acid; hydroxysuccinic acid

Chemical formula

C4H6O5

Molecular weight

134,09

Assay

Content not less than 99,0 %

Description

White or nearly white crystalline powder or granules

Identification

Melting range

127-132 °C

Test for malate

Passes test

Purity

Sulphated ash

Not more than 0,1 %

Fumaric acid

Not more than 1,0 %

Maleic acid

Not more than 0,05 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 297 FUMARIC ACID

Synonyms

 

Definition

Einecs

203-743-0

Chemical name

trans-Butenedioic acid; trans-1,2-Ethylene-dicarboxylic acid

Chemical formula

C4H4O4

Molecular weight

116,07

Assay

Content not less than 99,0 % on the anhydrous basis

Description

White crystalline powder or granules

Identification

Melting range

286-302 °C (closed capillary, rapid heating)

Test for double bonds

Passes test

Test for 1,2-dicarboxylic acid

Passes test

pH

3,0-3,2 (0,05 % solution at 25 °C)

Purity

Loss on drying

Not more than 0,5 % (120 °C, 4 hours)

Sulphated ash

Not more than 0,1 %

Maleic acid

Not more than 0,1 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 300 ASCORBIC ACID, L-ASCORBIC ACID

Synonyms

L-xylo-Ascorbic acid; L(+)- Ascorbic acid

Definition

Einecs

200-066-2

Chemical name

L-ascorbic acid; Ascorbic acid; 2,3-Didehydro-L-threo-hexono-1,4-lactone; 3-Keto-L-gulofuranolactone

Chemical formula

C6H8O6

Molecular weight

176,13

Assay

contains not less than 99 % of C6H8O6 after drying in a vacuum desiccator over sulphuric acid for 24 hours,

Description

White to pale yellow, odourless crystalline powder

Melting range

Between 189 °C and 193 °C with decomposition

Identification

Test for ascorbic acid

Passes test

pH

Between 2,4 and 2,8 (2 % aqueous solution)

Specific rotation

[α]D 20 between + 20,5° and + 21,5° (10 % w/v aqueous solution)

Purity

Loss on drying

Not more than 0,4 % (in vacuum over sulphuric acid, 24 hours)

Sulphated ash

Not more than 0,1 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 301 SODIUM ASCORBATE

Synonyms

Sodium L-ascorbate; L-Ascorbic acid monosodium salt

Definition

Einecs

205-126-1

Chemical name

Sodium ascorbate; Sodium L-ascorbate; 2,3-Didehydro-L-threo-hexono-1,4-lactone sodium enolate; 3-Keto-L-gulofurano-lactone sodium enolate

Chemical formula

C6H7O6Na

Molecular weight

198,11

Assay

Sodium ascorbate, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H7O6Na

Description

White or almost white, odourless crystalline powder which darkens on exposure to light

Identification

Test for ascorbate

Passes test

Test for sodium

Passes test

pH

Between 6,5 and 8,0 (10 % aqueous solution)

Specific rotation

[α]D 20 between + 103° and + 106° (10 % w/v aqueous solution)

Purity

Loss on drying

Not more than 0,25 % (in vacuum over sulphuric acid, 24 hours)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 302 CALCIUM ASCORBATE

Synonyms

Calcium ascorbate dihydrate

Definition

Einecs

227-261-5

Chemical name

Calcium ascorbate dihydrate; Calcium salt of 2,3-didehydro-L-threo-hexono-1,4-lactone dihydrate

Chemical formula

C12H14O12Ca·2H2O

Molecular weight

426,35

Assay

Content not less than 98 % on a volatile matter-free basis

Description

White to slightly pale greyish-yellow odourless crystalline powder

Identification

Test for ascorbate

Passes test

Test for calcium

Passes test

pH

Between 6,0 and 7,5 (10 % aqueous solution)

Specific rotation

[α]D 20 between + 95° and + 97° (5 % w/v aqueous solution)

Purity

Fluoride

Not more than 10 mg/kg (expressed as fluorine)

Volatile matter

Not more than 0,3 % determined by drying at room temperature for 24 hours in a desiccator containing sulphuric acid or phosphorus pentoxide

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 304 (i) ASCORBYL PALMITATE

Synonyms

L-ascorbyl palmitate

Definition

Einecs

205-305-4

Chemical name

Ascorbyl palmitate; L-ascorbyl palmitate; 2,3-didehydro-L-threo-hexono-1,4-lactone-6-palmitate; 6-palmitoyl-3-keto-L-gulofuranolactone

Chemical formula

C22H38O7

Molecular weight

414,55

Assay

Content not less than 98 % on the dried basis

Description

White or yellowish-white powder with a citrus-like odour

Identification

Melting range

Between 107 °C and 117 °C

Specific rotation

[α]D 20 between + 21° and + 24° (5 % w/v in methanol solution)

Purity

Loss on drying

Not more than 2,0 % (vacuum oven, 56-60 °C, 1 hour)

Sulphated ash

Not more than 0,1 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 304 (ii) ASCORBYL STEARATE

Synonyms

 

Definition

Einecs

246-944-9

Chemical name

Ascorbyl stearate; L-ascorbyl stearate; 2,3-didehydro-L-threo-hexono-1,4-lactone-6-stearate; 6-stearoyl-3-keto-L-gulofuranolactone

Chemical formula

C24H42O7

Molecular weight

442,6

Assay

Content not less than 98 %

Description

White or yellowish, white powder with a citrus-like odour

Identification

Melting point

About 116 °C

Purity

Loss on drying

Not more than 2,0 % (vacuum oven, 56-60 °C, 1 hour)

Sulphated ash

Not more than 0,1 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 306 TOCOPHEROL-RICH EXTRACT

Synonyms

 

Definition

Product obtained by the vacuum steam distillation of edible vegetable oil products, comprising concentrated tocopherols and tocotrienols

Contains tocopherols such as d-α-, d-β-, d-γ- and d-δ-tocopherols

Einecs

 

Chemical name

 

Chemical formula

 

Molecular weight

430,71 (d-α-tocopherol)

Assay

Content not less than 34 % of total tocopherols

Description

Brownish red to red, clear, viscous oil having a mild, characteristic odour and taste. May show a slight separation of wax-like constituents in microcrystalline form

Identification

By suitable gas liquid chromatographic method

 

Specific rotation

[α]D 20 not less than + 20°

Solubility

Insoluble in water. Soluble in ethanol. Miscible in ether

Purity

Sulphated ash

Not more than 0,1 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 307 ALPHA-TOCOPHEROL

Synonyms

dl-α-Tocopherol; (all rac)-α-Tocopherol

Definition

Einecs

233-466-0

Chemical name

DL-5,7,8-Trimethyltocol; DL-2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol

Chemical formula

C29H50O2

Molecular weight

430,71

Assay

Content not less than 96 %

Description

Slightly yellow to amber, nearly odourless, clear, viscous oil which oxidises and darkens on exposure to air or light

Identification

Solubility

Insoluble in water, freely soluble in ethanol, miscible in ether

Spectrophotometry

In absolute ethanol the maximum absorption is about 292 nm

Specific rotation

[α]D 25 0° ± 0,05° (1 in 10 solution in chloroform)

Purity

Refractive index

[n]D 20 1,503-1,507

Specific absorption in ethanol

Formula (292 nm) 71-76

(0,01 g in 200 ml of absolute ethanol)

Sulphated ash

Not more than 0,1 %

Lead

Not more than 2 mg/kg

E 308 GAMMA-TOCOPHEROL

Synonyms

dl-γ-Tocopherol

Definition

Einecs

231-523-4

Chemical name

2,7,8-trimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol

Chemical formula

C28H48O2

Molecular weight

416,69

Assay

Content not less than 97 %

Description

Clear, viscous, pale yellow oil which oxidises and darkens on exposure to air or light

Identification

Spectrometry

Maximum absorptions in absolute ethanol at about 298 nm and 257 nm

Purity

Specific absorption in ethanol

Formula (298 nm) between 91 and 97

Formula (257 nm) between 5,0 and 8,0

Refractive index

[n]D 20 1,503-1,507

Sulphated ash

Not more than 0,1 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 309 DELTA-TOCOPHEROL

Synonyms

 

Definition

Einecs

204-299-0

Chemical name

2,8-dimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol

Chemical formula

C27H46O2

Molecular weight

402,7

Assay

Content not less than 97 %

Description

Clear, viscous, pale yellowish or orange oil which oxidises and darkens on exposure to air or light

Identification

Spectrometry

Maximum absorptions in absolute ethanol at about 298 nm and 257 nm

Purity

Specific absorption

Formula

in ethanol

Formula (298 nm) between 89 and 95

Formula (257 nm) between 3,0 and 6,0

Refractive index

[n]D 20 1,500-1,504

Sulphated ash

Not more than 0,1 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 310 PROPYL GALLATE

Synonyms

 

Definition

Einecs

204-498-2

Chemical name

Propyl gallate; Propyl ester of gallic acid; n-propyl ester of 3,4,5-trihydroxybenzoic acid

Chemical formula

C10H12O5

Molecular weight

212,20

Assay

Content not less than 98 % on the anhydrous basis

Description

White to creamy-white, crystalline, odourless solid

Identification

Solubility

Slightly soluble in water, freely soluble in ethanol, ether and propane-1,2-diol

Melting range

Between 146 °C and 150 °C after drying at 110 °C for four hours

Purity

Loss on drying

Not more than 0,5% (110 °C, 4 hours)

Sulphated ash

Not more than 0,1 %

Free acid

Not more than 0,5 % (as gallic acid)

Chlorinated organic compound

Not more than 100 mg/kg (as C1)

Specific absorption in ethanol

Formula

(275 nm) not less than 485 and not more than 520

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 311 OCTYL GALLATE

Synonyms

 

Definition

Einecs

213-853-0

Chemical name

Octyl gallate; Octyl ester of gallic acid; n-octyl ester of 3,4,5-trihydroxybenzoic acid

Chemical formula

C15H22O5

Molecular weight

282,34

Assay

Content not less than 98 % after drying at 90 °C for six hours

Description

White to creamy-white odourless solid

Identification

Solubility

Insoluble in water, freely soluble in ethanol, ether and propane-1,2-diol

Melting range

Between 99 °C and 102 °C after drying at 90 °C for six hours

Purity

Loss on drying

Not more than 0,5 % (90 °C, 6 hours)

Sulphated ash

Not more than 0,05 %

Free acid

Not more than 0,5 % (as gallic acid)

Chlorinated organic compound

Not more than 100 mg/kg (as C1)

Specific absorption in ethanol

Formula

(275 nm) not less than 375 and not more than 390

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 312 DODECYL GALLATE

Synonyms

Lauryl gallate

Definition

Einecs

214-620-6

Chemical name

Dodecyl gallate; n-dodecyl (or lauryl) ester of 3,4,5-trihydroxybenzoic acid; Dodecyl ester of gallic acid

Chemical formula

C19H30O5

Molecular weight

338,45

Assay

Content not less than 98 % after drying at 90 °C for six hours

Description

White or creamy-white odourless solid

Identification

Solubility

Insoluble in water, freely soluble in ethanol and ether

Melting range

Between 95 °C and 98 °C after drying at 90 °C for six hours

Purity

Loss on drying

Not more than 0,5 % (90 °C, 6 hours)

Sulphated ash

Not more than 0,05 %

Free acid

Not more than 0,5 % (as gallic acid)

Chlorinated organic compound

Not more than 100 mg/kg (as Cl)

Specific absorption in ethanol

Formula

(275 nm) not less than 300 and not more than 325

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 315 ERYTHORBIC ACID

Synonyms

Isoascorbic acid; D-Araboascorbic acid

Definition

Einecs

201-928-0

Chemical name

D-Erythro-hex-2-enoic acid γ-lactone; Isoascorbic acid; D-Isoascorbic acid

Chemical formula

C6H8O6

Molecular weight

176,13

Assay

Content not less than 98 % on the anhydrous basis

Description

White to slightly yellow crystalline solid which darkens gradually on exposure to light

Identification

Melting range

About 164 °C to 172 °C with decomposition

Test for ascorbic acid/colour reaction

Passes test

Specific rotation

[α]D 25 10 % (w/v) aqueous solution between – 16,5° to – 18,0°

Purity

Loss on drying

Not more than 0,4 % after drying under (reduced pressure on silica gel, 3 hours)

Sulphated ash

Not more than 0,3 %

Oxalate

To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear

Lead

Not more than 2 mg/kg

E 316 SODIUM ERYTHORBATE

Synonyms

Sodium isoascorbate

Definition

Einecs

228-973-9

Chemical name

Sodium isoascorbate; Sodium D-isoascorbic acid; Sodium salt of 2,3-didehydro-D-erythro-hexono-1,4-lactone; 3-keto-D-gulofurano-lactone sodium enolate monohydrate

Chemical formula

C6H7O6Na·H2O

Molecular weight

216,13

Assay

Content not less than 98 % after drying in a vacuum desiccator over sulphuric acid for 24 hours expressed on the monohydrate basis

Description

White crystalline solid

Identification

Solubility

Freely soluble in water, very slightly soluble in ethanol

Test for ascorbic acid/colour reaction

Passes test

Test for sodium

Passes test

pH

5,5 to 8,0 (10 % aqueous solution)

Specific rotation

[α]D 25 10 % (w/v) aqueous solution between + 95° and + 98°

Purity

Loss on drying

Not more than 0,25 % after drying (in vacuum over sulphuric acid, 24 hours)

Oxalate

To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear.

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ)

Synonyms

TBHQ

Definition

Einecs

217-752-2

Chemical name

Tert-butyl-1,4-benzenediol; 2-(1,1-Dimethylethyl)-1,4-benzenediol

Chemical formula

C10H14O2

Molecular weight

166,22

Assay

Content not less than 99 % of C10H14O2

Description

White crystalline solid having a characteristic odour

Identification

Solubility

Practically insoluble in water; soluble in ethanol

Melting point

Not less than 126,5 °C

Phenolics

Dissolve about 5 mg of the sample in 10 ml of methanol and add 10,5 ml of dimethylamine solution (1 in 4). A red to pink colour is produced

Purity

Tertiary-Butyl-p-benzoquinone

Not more than 0,2 %

2,5-Di-tertiary-butyl hydroquinone

Not more than 0,2 %

Hydroxyquinone

Not more than 0,1 %

Toluene

Not more than 25 mg/kg

Lead

Not more than 2 mg/kg

E 320 BUTYLATED HYDROXYANISOLE (BHA)

Synonyms

BHA

Definition

Einecs

246-563-8

Chemical name

3-Tertiary-butyl-4-hydroxyanisole; A mixture of 2-tertiary-butyl-4-hydroxyanisole and 3-tertiary-butyl-4-hydroxyanisole

Chemical formula

C11H16O2

Molecular weight

180,25

Assay

Content not less than 98,5 % of C11H16O2 and not less than 85 % of 3-tertiary-butyl-4-hydroxyanisole isomer

Description

White or slightly yellow flakes or waxy solid with a slight aromatic smell

Identification

Solubility

Insoluble in water, freely soluble in ethanol

Melting range

Between 48 °C and 63 °C

Colour reaction

Passes test for phenol groups

Purity

Sulphated ash

Not more than 0,05 % after calcination at 800 ± 25 °C

Phenolic impurities

Not more than 0,5 %

Specific absorption

Formula (290 nm) not less than 190 and not more than 210

Formula (228 nm) not less than 326 and not more than 345

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 321 BUTYLATED HYDROXYTOLUENE (BHT)

Synonyms

BHT

Definition

Einecs

204-881-4

Chemical name

2,6-Ditertiary-butyl-p-cresol; 4-Methyl-2,6-ditertiarybutylphenol

Chemical formula

C15H24O

Molecular weight

220,36

Assay

Content not less than 99 %

Description

White, crystalline or flaked solid, odourless or having a characteristic faint aromatic odour

Identification

Solubility

Insoluble in water and propane- 1,2-diol

Freely soluble in ethanol

Melting point

At 70 °C

Spectrometry

The absorption in the range 230 to 320 nm of a 2 cm layer of a 1 in 100 000 solution in dehydrated ethanol exhibits a maximum only at 278 nm

Purity

Sulphated ash

Not more than 0,005 %

Phenolic impurities

Not more than 0,5 %

Specific absorption in ethanol

Formula

(278 nm) not less than 81 and not more than 88

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 322 LECITHINS

Synonyms

Phosphatides; Phospholipids

Definition

Lecithins are mixtures or fractions of phosphatides obtained by physical procedures from animal or vegetable foodstuffs; they also include hydrolysed products obtained through the use of harmless and appropriate enzymes. The final product must not show any signs of residual enzyme activity

The lecithins may be slightly bleached in aqueous medium by means of hydrogen peroxide. This oxidation must not chemically modify the lecithin phosphatides

Einecs

232-307-2

Chemical name

 

Chemical formula

 

Molecular weight

 

Assay

Lecithins: not less than 60,0 % of substances insoluble in acetone

Hydrolysed lecithins: not less than 56,0 % of substances insoluble in acetone

Description

Lecithins: brown liquid or viscous semi-liquid or powder

Hydrolysed lecithins: light brown to brown viscous liquid or paste

Identification

Test for choline

Passes test

Test for phosphorus

Passes test

Test for fatty acids

Passes test

Test for hydrolysed lecithin

To a 800 ml beaker add 500 ml of water (30-35 °C). Then slowly add 50 ml of the sample with constant stirring. Hydrolysed lecithin will form a homogeneous emulsion. Non-hydrolysed lecithin will form a distinct mass of about 50 g

Purity

Loss on drying

Not more than 2,0 % (105 °C, 1 hour)

Toluene-insoluble matter

Not more than 0,3 %

Acid value

Lecithins: not more than 35 mg of potassium hydroxide per gram

Hydrolysed lecithins: not more than 45 mg of potassium hydroxide per gram

Peroxide value

Equal to or less than 10

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

E 325 SODIUM LACTATE

Synonyms

 

Definition

Einecs

200-772-0

Chemical name

Sodium lactate; Sodium 2-hydroxypropanoate

Chemical formula

C3H5NaO3

Molecular weight

112,06 (anhydrous)

Assay

Content not less than 57 % and not more than 66 %

Description

Colourless, transparent, liquid. Odourless, or with a slight, characteristic odour

Identification

Test for lactate

Passes test

Test for potassium

Passes test

pH

6,5 to 7,5 (20 % aqueous solution)

Purity

Acidity

Not more than 0,5 % after drying expressed as lactic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

Reducing substances

No reduction of Fehling's solution

Note: This specification refers to a 60 % aqueous solution

E 326 POTASSIUM LACTATE

Synonyms

 

Definition

Einecs

213-631-3

Cheminal name

Potassium lactate; Potassium 2-hydroxypropanoate

Chemical formula

C3H5O3K

Molecular weight

128,17 (anhydrous)

Assay

Content not less than 57 % and not more than 66 %

Description

Slightly viscous, almost odourless clear liquid. Odourless, or with a slight, characteristic odour

Identification

Ignition

Ignite potassium lactate solution to an ash. The ash is alkaline, and an effervescence occurs when acid is added

Colour reaction

Overlay 2 ml of potassium lactate solution on 5 ml of a 1 in 100 solution of catechol in sulphuric acid. A deep red colour is produced at the zone of contact

Test for potassium

Passes test

Test for lactate

Passes test

Purity

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

Acidity

Dissolve 1 g of potassium lactate solution in 20 ml of water, add 3 drops of phenolphthalein TS and titrate with 0,1 N sodium hydroxide. Not more than 0,2 ml should be required

Reducing substances

No reduction of Fehling's solution

Note: This specification refers to a 60 % aqueous solution

E 327 CALCIUM LACTATE

Synonyms

 

Definition

Einecs

212-406-7

Chemical name

Calcium dilactate; Calcium dilactate hydrate; 2-Hydroxypropanoic acid calcium salt

Chemical formula

(C3H5O2)2 Ca·nH2O (n = 0 - 5)

Molecular weight

218,22 (anhydrous)

Assay

Content not less than 98 % on the anhydrous basis

Description

Almost odourless, white crystalline powder or granules

Identification

Test for lactate

Passes test

Test for calcium

Passes test

Solubility

Soluble in water and practically insoluble in ethanol

pH

Between 6,0 and 8,0 (5 % solution)

Purity

Loss on drying

anhydrous: not more than 3,0 % (120 °C, 4 hours)

with 1 molecule of water: not more than 8,0 % (120 °C, 4 hours)

with 3 molecules of water: not more than 20,0 % (120 °C, 4 hours)

with 4,5 molecules of water: not more than 27,0 % (120 °C, 4 hours)

Acidity

Not more than 0,5 % of the dry matter expressed as lactic acid

Fluoride

Not more than 30 mg/kg (expressed as fluorine)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

Reducing substances

No reduction of Fehling's solution

E 330 CITRIC ACID

Synonyms

 

Definition

Citric acid is produced from lemon or pineapple juice, by fermentation of carbohydrate solutions or other suitable media using Candida spp. or non-toxicogenic strains of Aspergillus niger

Einecs

201-069-1

Chemical name

Citric acid; 2-Hydroxy-1,2,3-propanetricarboxylic acid; β-Hydroxytricarballylic acid

Chemical formula

(a)

C6H8O7 (anhydrous)

(b)

C6H8O7·H2O (monohydrate)

Molecular weight

(a)

192,13 (anhydrous)

(b)

210,15 (monohydrate)

Assay

Citric acid may be anhydrous or it may contain 1 molecule of water. Citric acid contains not less than 99,5 % of C6H8O7, calculated on the anhydrous basis

Description

Citric acid is a white or colourless, odourless, crystalline solid, having a strongly acid taste. The monohydrate effloresces in dry air

Identification

Solubility

Very soluble in water; freely soluble in ethanol; soluble in ether

Purity

Water content

Anhydrous citric acid contains not more than 0,5 % water; citric acid monohydrate contains not more than 8,8 % water (Karl Fischer method)

Sulphated ash

Not more than 0,05 % after calcination at 800 ± 25 °C

Arsenic

Not more than 1 mg/kg

Lead

Not more than 0,5 mg/kg

Mercury

Not more than 1 mg/kg

Oxalates

Not more than 100 mg/kg, expressed as oxalic acid, after drying

Readily carbonisable substances

Heat 1 g of powdered sample with 10 ml of 98 % minimum sulphuric acid in a water bath at 90 °C in the dark for one hour. Not more than a pale brown colour should be produced (Matching Fluid K)

E 331 (i) MONOSODIUM CITRATE

Synonyms

Monobasic sodium citrate

Definition

Einecs

242-734-6

Chemical name

Monosodium citrate; Monosodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

Chemical formula

(a)

C6H7O7Na (anhydrous)

(b)

C6H7O7Na·H2O (monohydrate)

Molecular weight

(a)

214,11 (anhydrous)

(b)

232,23 (monohydrate)

Assay

Content not less than 99 % on the anhydrous basis

Description

Crystalline white powder or colourless crystals

Identification

Test for citrate

Passes test

Test for sodium

Passes test

pH

Between 3,5 and 3,8 (1 % aqueous solution)

Purity

Loss on drying

anhydrous: not more than 1,0 % (140 °C, 0,5 hour)

monohydrate: not more than 8,8 % (180 °C, 4 hours)

Oxalates

Not more than 100 mg/kg expressed as oxalic acid, after drying

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

E 331 (ii) DISODIUM CITRATE

Synonyms

Dibasic sodium citrate

Definition

Einecs

205-623-3

Chemical name

Disodium citrate; Disodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid; Disodium salt of citric acid with 1,5 molecules of water

Chemical formula

C6H6O7Na2·1,5H2O

Molecular weight

263,11

Assay

Content not less than 99 % on the anhydrous basis

Description

Crystalline white powder or colourless crystals

Identification

Test for citrate

Passes test

Test for sodium

Passes test

pH

Between 4,9 and 5,2 (1 % aqueous solution)

Purity

Loss on drying

Not more than 13,0 % (180 °C, 4 hours)

Oxalates

Not more than 100 mg/kg expressed as oxalic acid, after drying

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

E 331 (iii) TRISODIUM CITRATE

Synonyms

Tribasic sodium citrate

Definition