Commission Directive 95/45/EC of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs (Text with EEA relevance) (repealed)
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THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption(1), as last amended by Directive 94/34/EC(2), and in particular Article 3 (3) (a) thereof,
After consulting the Scientific Committee for Food,
Whereas it is necessary to establish purity criteria for all colours mentioned in European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs(3);
Whereas it is necessary to revise the purity criteria for colours mentioned in the Council Directive of 23 October 1962 on the approximation of the rules of the Member States concerning the colouring matters authorized for use in foodstuffs intended for human consumption(4), as last amended by Directive 85/7/EEC(5);
Whereas it is necessary to take into account the specifications and analytical techniques for colours as set out in the Codex Alimentarius and the Joint FAO/WHO Expert Committee on Food Additives (JECFA);
Whereas food additives, prepared by production methods or starting materials significantly different from those included in the evaluation of the Scientific Committee for Food, or different from those mentioned in this Directive, shall be submitted for evaluation by the Scientific Committee for Food for the purposes of a full evaluation with emphasis on the purity criteria;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,
HAS ADOPTED THIS DIRECTIVE:
The purity criteria referred to in Article 3 (3) (a) of Directive 89/107/EEC for colours mentioned in Directive 94/36/EC are set out in the Annex hereto.
Article 8 and Annex III to the Directive of 23 October 1962 are hereby deleted.
1.Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1996. They shall immediately inform the Commission thereof.
When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
2.Products put on the market or labelled before 1 July 1996 which do not comply with this Directive may, however, be marketed until stocks are exhausted.
This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Communities.
This Directive is addressed to the Member States.
| 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 sulfate 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. |
| HCI insoluble matter | Not more than 0,5 % |
| Ether extractable matter | Not more than 0,2 % (under neutral conditions) |
| Specific purity criteria for the corresponding colours are applicable. |
| E 101 (i) RIBOFLAVIN | ||
| Synonyms | Lactoflavin | |
| Class | Isoalloxazine | |
| Einecs | 201-507-1 | |
| Chemical names | 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 | |
 at ca 444 nm in aqueous solution | ||
| Description | Yellow to orange-yellow crystalline powder, with slight odour | |
| Identification | ||
|---|---|---|
| A. 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 | ||
| [X1Maximum in water at ca 444 nm] | ||
| B. Specific rotation |  and -140° in a 0,05 N sodium hydroxide solution | |
| Purity | ||
| Loss on drying | Not more than 1,5 % after drying at 105 °C for 4 hrs | |
| Sulfated 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 10 mg/kg | |
| Mercury | Not more than 1 mg/kg | |
| Cadmium | Not more than 1 mg/kg | |
| Heavy metals (as Pb) | Not more than 40 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 | |
| Class | Isoalloxazine | |
| Einecs | 204-988-6 | |
| Chemical names | 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 | 541,36 | |
| Assay | Content not less than 95 % total colouring matters calculated as C17H20N4NaO9P.2H2O | |
 at ca 375 nm in aqueous solution | ||
| Description | Yellow to orange crystalline hygroscopic powder, with slight odour and a bitter taste | |
| Identification | ||
|---|---|---|
| A. 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 | ||
| [X1Maximum in water at ca 444 nm] | ||
| B. Specific rotation |  and +42° in a 5 molar HCI solution | |
| Purity | ||
| Loss on drying | Not more than 8 % (100 °C, 5 hrs in vacuum over P2O5) for the dihydrate form | |
| Sulfated 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 10 mg/kg | |
| Mercury | Not more than 1 mg/kg | |
| Cadmium | Not more than 1 mg/kg | |
| Heavy metals (as Pb) | Not more than 40 mg/kg | |
| [F1E 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 sulfate as the principal uncoloured components. | |
| Sunset Yellow FCF is described as the sodium salt. The calcium and the potassium salt are also permitted. | ||
| Class | Monoazo | |
| Colour Index No | 15985 | |
| EINECS | 220-491-7 | |
| Chemical names | Disodium 2-hydroxy-1-(4-sulfonatophenylazo)naphthalene-6-sulfonate | |
| Chemical formula | C 16 H 10 N 2 Na 2 O 7 S 2 | |
| Molecular weight | 452,37 | |
| Assay | Content not less than 85 % total colouring matters calculated as the sodium salt | |
 555 at ca 485 nm in aqueous solution at pH 7 | ||
| Description | Orange-red powder or granules | |
| Identification | ||
|---|---|---|
A. Spectrometry | Maximum in water at ca 485 nm at pH 7 | |
B. Orange solution in water | ||
| 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] | |
| E 120 COCHINEAL, CARMINIC ACID, CARMINES | ||
| Definition | Carmines and carminic acid are obtained from aqueous, aqueous alcoholic or alcoholic extracts from Cochineal, with 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. | ||
| Class | Anthraquinone | |
| Colour Index No | 75470 | |
| Einecs | Cochineal: 215-680-6; carminic acid: 215-023-3; carmines: 215-724-4 | |
| Chemical names | 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 | ||
| Purity | ||
| 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 | |
| Heavy metals (as Pb) | Not more than 40 mg/kg | |
| 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 natural 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 neutralized 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. | ||
| Class | Porphyrin | |
| Colour Index No | 75815 | |
| Einecs | ||
| Chemical names | The major colouring principles in their acid forms are
| |
| 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. | |
 at ca 405 nm in aqueous phosphate buffer at pH 7,5 | ||
 at ca 630 nm in aqueous phosphate buffer at pH 7,5 | ||
| Description | Dark green to blue/black powder | |
| Identification | ||
|---|---|---|
| [X1Spectrometry | Maximum in aqueous phosphate buffer at pH 7,5 at ca 405 nm and at ca 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 10 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 | |
| E 150a PLAIN CARAMEL | ||
| a Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm. | ||
| 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 caramelization, acids, alkalis and salts may be employed, with the exception of ammonium compounds and sulphites. | |
| Einecs | 232-435-9 | |
| Description | Dark brown to black liquids or solids | |
| Purity | ||
|---|---|---|
| Colour bound by DEAE cellulose | Not more than 50 % | |
| Colour bound by phosphoryl cellulose | Not more than 50 % | |
| Colour intensitya | 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 | |
| Heavy metals (as Pb) | Not more than 25 mg/kg | |
| E 150b CAUSTIC SULPHITE CARAMEL | ||
| a Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm. | ||
| b Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units. | ||
| 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. | |
| Einecs | 232-435-9 | |
| Description | Dark brown to black liquids or solids | |
| Purity | ||
|---|---|---|
| Colour bound by DEAE cellulose | More than 50 % | |
| Colour intensitya | 0,05—0,13 | |
| Total nitrogen | Not more than 0,3 %b | |
| Sulphur dioxide | Not more than 0,2 %b | |
| Total sulphur | 0,3—3,5 %b | |
| 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 | |
| Heavy metals (as Pb) | Not more than 25 mg/kg | |
| E 150c AMMONIA CARAMEL | ||
| a Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm. | ||
| b Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units. | ||
| 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. | |
| Einecs | 232-435-9 | |
| Description | Dark brown to black liquids or solids | |
| Purity | ||
|---|---|---|
| Colour bound by DEAE cellulose | Not more than 50 % | |
| Colour bound by phosphoryl cellulose | More than 50 % | |
| Colour intensitya | 0,08—0,36 | |
| Ammoniacal nitrogen | Not more than 0,3 %b | |
| 4-methylimidazole | Not more than 250 mg/kgb | |
| 2-acetyl-4-tetrahydroxy-butylimidazole | Not more than 10 mg/kgb | |
| Total sulphur | Not more than 0,2 %b | |
| Total nitrogen | 0,7—3,3 %b | |
| 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 | |
| Heavy metals (as Pb) | Not more than 25 mg/kg | |
| E 150d SULPHITE AMMONIA CARAMEL | ||
| a Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm. | ||
| b Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units. | ||
| c Absorbance ratio of alcohol precipitate is defined as the absorbance of the precipitate at 280 nm divided by the absorbance at 560 nm (1 cm cell). | ||
| 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). | |
| Einecs | 232-435-9 | |
| Description | Dark brown to black liquids or solids | |
| Purity | ||
|---|---|---|
| Colour bound by DEAE cellulose | More than 50 % | |
| Colour intensitya | 0,10—0,60 | |
| Ammoniacal nitrogen | Not more than 0,6 %b | |
| Sulphur dioxide | Not more than 0,2 %b | |
| 4-methylimidazole | Not more than 250 mg/kgb | |
| Total nitrogen | 0,3—1,7 %b | |
| Total sulphur | 0,8—2,5 %b | |
| Nitrogen/sulphur ratio of alcohol precipitate | 0,7—2,7 | |
| Absorbance ratio of alcohol precipitatec | 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 | |
| Heavy metals (as Pb) | Not more than 25 mg/kg | |
| E 153 VEGETABLE CARBON | ||
| Synonyms | Vegetable black | |
| Definition | Vegetable carbon is produced by the carbonization of vegetable material such as wood, cellulose residues, peat and coconut and other shells. The raw material is carbonized at high temperatures. 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 | 215-609-9 | |
| Chemical names | Carbon | |
| Chemical formula | C | |
| Molecular weight | 12,01 | |
| Assay | Content not less than 95 % of carbon calculated on an anhydrous and ash-free basis | |
| Description | Black powder, odourless and tasteless | |
| Identification | ||
|---|---|---|
| A. Solubility | Insoluble in water and organic solvents | |
| B. 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 10 mg/kg | |
| Mercury | Not more than 1 mg/kg | |
| Cadmium | Not more than 1 mg/kg | |
| Heavy metals (as Pb) | Not more than 40 mg/kg | |
| Polyaromatic hydrocarbons | The extract obtained by extraction of 1 g of the product with 10 g pure cyclohexane in a continuous extraction apparatus shall be colourless, and the fluorescence of the extract in ultraviolet light shall not be more intense than that of a solution of 0,100 mg of quinine sulfate in 1000 ml of 0,01 M sulphuric acid. | |
| Loss on drying | Not more than 12 % (120 °C, 4 hrs) | |
| 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 154 BROWN FK | ||
| Synonyms | CI Food Brown 1 | |
| Definition | Brown FK consists essentially of a mixture of: I sodium 4-(2,4-diaminophenylazo) benzenesulfonate II sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate III disodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate) IV disodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate) V disodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate) VI trisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate) and subsidiary colouring matters together with water, sodium chloride and/or sodium sulfate as the principal uncoloured components. | |
| Brown FK is described as the sodium salt. The calcium and the potassium salt are also permitted. | ||
| Class | Azo (a mixture of mono-, bis- and trisazo colours) | |
| Einecs | ||
| Chemical names | A mixture of: I sodium 4-(2,4-diaminophenylazo) benzenesulfonate II sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate III disodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate) IV disodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate) V disodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate) VI trisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate) | |
| Chemical formula | I C12H11N4NaO3S II C13H13N4NaO3S III C18H14N6Na2O6S2 IV C18H14N6Na2O6S2 V C19H16N6Na2O6S2 VI C24H17N8Na3O9S3 | |
| Molecular weight | I 314,30 II 328,33 III 520,46 IV 520,46 V 534,47 VI 726,59 | |
| Assay | Content not less than 70 % total colouring matters | |
| Of the total colouring matters present the proportions of the components shall not exceed: I 26 % II 17 % III 17 % IV 16 % V 20 % VI 16 % | ||
| Description | Red-brown powder or granules | |
| Identification | ||
|---|---|---|
| Orange to reddish solution | ||
| Purity | ||
| Water insoluble matter | Not more than 0,2 % | |
| Subsidiary colouring matters | Not more than 3,5 % | |
| Organic compounds other than colouring matters: | ||
| 4-aminobenzene-1-sulfonic acid | Not more than 0,7 % | |
| m-phenylenediamine and 4-methyl-m-phenylenediamine | Not more than 0,35 % | |
| Unsulfonated primary aromatic amines other than m-phenylene diamine and 4-methyl-m-phenylene diamine | Not more than 0,007 % (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 10 mg/kg | |
| Mercury | Not more than 1 mg/kg | |
| Cadmium | Not more than 1 mg/kg | |
| Heavy metals (as Pb) | Not more than 40 mg/kg | |
| [F2E 160 a (i) MIXED CAROTENES | ||
| a Benzene not more than 0,05 % v/v. | ||
| 1. Plant carotenes | ||
|---|---|---|
| Synonyms | CI Food Orange 5 | |
| Definition | Mixed carotenes are obtained by solvent extraction of natural 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 a , dichloromethane and carbon dioxide. | |
| Class | Carotenoid | |
| Colour index No | 75130 | |
| EINECS | 230-636-6 | |
| Chemical formula | Beta-carotene: C 40 H 56 | |
| 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 vegetable oils: not less than 0,2 % in edible fats | |
| Identification | ||
| A. 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 5 mg/kg | |
| 2. Algal carotenes | ||
| Synonyms | CI Food Orange 5 | |
| Definition | Mixed carotenes may also be produced from natural 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. | |
| Class | Carotenoid | |
| Colour index No | 75130 | |
| Chemical formula | Beta-carotene: C 40 H 56 | |
| Molecular weight | Beta-carotene: 536,88 | |
| Assay | Content of carotenes (calculated as beta-carotene) is not less than 20 %. | |
| Identification | ||
| A. 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 5 mg/kg | |
| E 160 a (ii) BETA-CAROTENE | ||
| 1. Beta-carotene | ||
|---|---|---|
| Synonyms | CI Food Orange 5 | |
| Definition | These specifications apply predominantly to all trans isomers of beta-carotene together with minor amounts of other carotenoids. Diluted and stabilised preparations may have different trans-cis isomer ratios. | |
| Class | Carotenoid | |
| Colour index No | 40800 | |
| EINECS | 230-636-6 | |
| Chemical names | Beta-carotene, beta,beta-carotene | |
| Chemical formula | C 40 H 56 | |
| Molecular weight | 536,88 | |
| Assay | Not less than 96 % total colouring matters (expressed as beta-carotene) | |
| Description | Red to brownish-red crystals or crystalline powder | |
| Identification | ||
| A. Spectrometry | Maximum in cyclohexane at 453 to 456 nm | |
| Purity | ||
| Sulfated 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 | |
| 2. 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 natural strains of the fungus Blakeslea trispora . The beta-carotene is extracted from the biomass with ethyl acetate, or isobutyl acetate followed by isopropyl alcohol, 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. | |
| Class | Carotenoid | |
| Colour index No | 40800 | |
| EINECS | 230-636-6 | |
| Chemical names | Beta-carotene, beta,beta-carotene | |
| Chemical formula | C 40 H 56 | |
| Molecular weight | 536,88 | |
| Assay | Not less than 96 % total colouring matters (expressed as beta-carotene) | |
| Description | Red, brownish-red or purple-violet crystals or crystalline powder (colour varies according to extraction solvent used and conditions of crystallisation) | |
| Identification | ||
| A. 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 % | ||
| Isopropyl alcohol: Not more than 0,1 % | ||
| Sulfated 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 | |
| Mycotoxins: | ||
| Aflatoxin B1 | Absent | |
| Trichothecene (T2) | Absent | |
| Ochratoxin | Absent | |
| Zearalenone | Absent | |
| Microbiology: | ||
| Moulds | Not more than 100/g | |
| Yeasts | Not more than 100/g | |
| Salmonella | Absent in 25 g | |
| Escherichia coli | Absent in 5 g] | |
| E 160d LYCOPENE | ||
| Synonyms | Natural Yellow 27 | |
| Definition | Lycopene is obtained by solvent extraction of the natural strains of red tomatoes (Lycopersicon esculentum L.) with subsequent removal of the solvent. Only the following solvents may be used: dichloromethane, carbon dioxide, ethyl acetate, acetone, propan-2-ol, methanol, ethanol, hexane. The major colouring principle of tomatoes is lycopene, minor amounts of other carotenoid pigments may be present. Beside the other colour pigments the product may contain oils, fats, waxes, and flavour components naturally occurring in tomatoes. | |
| Class | Carotenoid | |
| Colour Index No | 75125 | |
| Chemical names | Lycopene, Lycopene, ψ,ψ-carotene | |
| Chemical formula | C40H56 | |
| Molecular weight | 536,85 | |
| [X1Assay | Not less than 5 % of total colouring matters E1 % 1 cm 3 450 at ca 472 nm in hexane] | |
| Description | Dark red viscous liquid | |
| Identification | ||
|---|---|---|
| Spectrometry | Maximum in hexane at ca 472 nm | |
| 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 | |
| Sulfated ash | Not more than 0,1 % | |
| 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 | |
| Heavy metals (as Pb) | Not more than 40 mg/kg | |
| E 160e BETA-APO-8′-CAROTENAL (C30) | ||
| Synonyms | CI Food Orange 6 | |
| Definition | These specifications apply to predominantly all trans isomer of β-apo-8′-carotenal together with minor amounts of other carotenoids. Diluted and stabilized 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. | |
| Class | Carotinoid | |
| Colour Index No | 40820 | |
| Einecs | 214-171-6 | |
| Chemical names | 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 | |
 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 | ||
| Sulfated 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 10 mg/kg | |
| Mercury | Not more than 1 mg/kg | |
| Cadmium | Not more than 1 mg/kg | |
| [X1Heavy metals (as Pb) | Not more than 40 mg/kg] | |
| E 160f ETHYL ESTER OF BETA-APO-8′-CAROTENOIC ACID (C30) | ||
| Synonyms | CI Food Orange 7, β-apo-8′-carotenoic ester | |
| Definition | These specifications apply to predominantly all trans isomer of β-apo-8′-carotenoic acid ethyl ester together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from β-apo-8′-carotenoic acid ethyl ester meeting these specifications and include solutions or suspensions of β-apo-8′-carotenoic acid ethyl ester in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios. | |
| Class | Carotinoid | |
| Colour Index No | 40825 | |
| Einecs | 214-173-7 | |
| Chemical names | β-Apo-8′-carotenoic acid ethyl ester, ethyl 8′-apo-β-caroten-8′-oate | |
| Chemical formula | C32H44O2 | |
| Molecular weight | 460,70 | |
| Assay | Not less than 96 % of total colouring matters | |
 at ca 449 nm in cyclohexane | ||
| Description | Red to violet-red crystals or crystalline powder | |
| Identification | ||
|---|---|---|
| Spectrometry | Maximum in cyclohexane at ca 449 nm | |
| Purity | ||
| Sulfated ash | Not more than 0,1 % | |
| Subsidiary colouring matters | Carotenoids other than β-apo-8′-carotenoic acid ethyl ester: not more than 3,0 % of total colouring matters Not more than 3,0 % der Farbstoffe insgesamt | |
| 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 | |
| [X1Heavy metals (as Pb) | Not more than 40 mg/kg.] | |
| 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. | |
| Class | Inorganic | |
| Colour Index No | 77220 | |
| Einecs | Calcium carbonate : 207-439-9 Limestone : 215-279-6 | |
| Chemical names | 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 1,5 % | |
| 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 10 mg/kg | |
| Cadmium | Not more than 1 mg/kg | |
| [F1E 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. | |
| Class | Inorganic | |
| Colour Index No | 77891 | |
| EINECS | 236-675-5 | |
| Chemical names | Titanium dioxide | |
| Chemical formula | TiO 2 | |
| 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 sulfuric acid. | |
| Purity | ||
| Loss on Drying | Not more than 0,5 % (105 o C, 3 hours) | |
| Loss on Ignition | Not more than 1,0 % on a volatile matter free basis (800 o C) | |
| Aluminum 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 | |
| Antimony | Not more than 50 mg/kg by total dissolution | |
| Arsenic | Not more than 3 mg/kg by total dissolution | |
| Lead | Not more than 10 mg/kg by total dissolution | |
| Mercury | Not more than 1 mg/kg by total dissolution | |
| Zinc | Not more than 50 mg/kg by total dissolution.] | |
| 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 si achieved by the selection and control of the source of the iron and/or by the extent of chemical purification during the manufacturing process. | |
| Class | Inorganic | |
| 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 names | 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).xH2O 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 5 mg/kg | |
| Barium | Not more than 50 mg/kg | |
| Cadmium | Not more than 5 mg/kg | |
| Chromium | Not more than 100 mg/kg | |
| Copper | Not more than 50 mg/kg | |
| Lead | Not more than 20 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, Al | |
| 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 names | 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. The resulting solution gives positive tests for aluminium. | |
| 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 | |
| Heavy metals (as Pb) | Not more than 40 mg/kg | |
| E 174 SILVER | ||
| Synonyms | Argentum, Ag | |
| Class | Inorganic | |
| Colour Index No | 77820 | |
| Einecs | 231-131-3 | |
| Chemical names | Silver | |
| Chemical formula | Ag | |
| Atomic weight | 107,87 | |
| Assay | Content not less than 99,5 % Ag | |
| Description | Silver-coloured powder or tiny sheets | |
| E 175 GOLD | ||
| Synonyms | Pigment Metal 3, Aurum, Au | |
| Class | Inorganic | |
| Colour Index No | 77480 | |
| Einecs | 231-165-9 | |
| Chemical names | Gold | |
| Chemical formula | Au | |
| Atomic weight | 197,0 | |
| Assay | Content not less than 90 % Au | |
| Description | Gold-coloured powder or tiny sheets | |
| Purity | ||
|---|---|---|
| Silver | Not more than 7 % | After complete dissolution |
| Copper | Not more than 4 % | |
Editorial Information
X1 Substituted by Corrigendum to Commission Directive 95/45/EC of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs (Official Journal of the European Communities L 226 of 22 September 1995).
Textual Amendments
OJ No 115,11.11.1962, p.2645/62.
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