Commission Directive 2008/128/EC of 22 December 2008 laying down specific purity criteria concerning colours for use in foodstuffs (Codified version) (Text with EEA relevance)
2008/128/EC • 32008L0128
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10.1.2009
EN
Official Journal of the European Union
L 6/20
COMMISSION DIRECTIVE 2008/128/EC
of 22 December 2008
laying down specific purity criteria concerning colours for use in foodstuffs
(Codified version)
(Text with EEA relevance)
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), and in particular Article 3(3)(a) thereof,
Whereas:
(1)
Commission Directive 95/45/EC of 26 July 1995 laying down specific criteria concerning colours for use in foodstuffs (2) has been substantially amended several times (3). In the interests of clarity and rationality the said Directive should be codified.
(2)
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 (4).
(3)
It is necessary to take into account the specifications and analytical techniques for colours as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
(4)
Food additives prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food or different from those mentioned in this Directive should be submitted for safety evaluation by the European Food Safety Authority with emphasis on the purity criteria.
(5)
The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health.
(6)
This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B,
HAS ADOPTED THIS DIRECTIVE:
Article 1
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 Annex I hereto.
Article 2
Directive 95/45/EC, as amended by the Directives listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.
Article 3
This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 22 December 2008.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 40, 11.2.1989, p. 27.
(2) OJ L 226, 22.9.1995, p. 1.
(3) See Annex II, Part A.
(4) OJ L 237, 10.9.1994, p. 13.
ANNEX I
A. GENERAL SPECIFICATIONS FOR ALUMINIUM LAKES OF COLOURS
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.
HCl 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.
B. SPECIFIC CRITERIA OF PURITY
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 natural strains of Curcuma longa L. In order to obtain a concentrated curcumin powder, the extract is purified by crystallisation. 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 occuring in turmeric may be present.
Only the following solvents may be used in the extraction: ethylacetate, acetone, carbon dioxide, dichloromethane, n-butanol, methanol, ethanol, hexane.
Class
Dicinnamoylmethane
Colour Index No
75300
Einecs
207-280-5
Chemical names
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
E1 cm 1 %1 607 at ca 426 nm in ethanol
Description
Orange-yellow crystalline powder
Identification
A.
Spectrometry
Maximum in ethanol at ca 426 nm
B.
Melting Range
179 °C-182 °C
Purity
Solvent residues
Ethylacetate
Acetone
n-butanol
Methanol
Ethanol
Hexane
Not more than 50 mg/kg, singly or in combination
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
Heavy metals (as Pb)
Not more than 40 mg/kg
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
E1 cm 1 % 328 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
The ratio A444/A267 is between 0,36 and 0,39
in aqueous solution
Maximum in water at ca 444 nm
B.
Specific rotation
[α]D20 between – 115° 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
E1 cm 1 % 250 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
The ratio A444/A267 is between 0,35 and 0,40
in aqueous solution
Maximum in water at ca 444 nm
B.
Specific rotation
[α]D20 between + 38° and + 42° in a 5 molar HCl 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
E 102 TARTRAZINE
Synonyms
CI Food Yellow 4
Definition
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 sulfate as the principal uncoloured components.
Tartrazine is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class
Monoazo
Colour Index No
19140
Einecs
217-699-5
Chemical names
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
E1 cm 1 % 530 at ca 426 nm in aqueous solution
Description
Light orange powder or granules
Identification
A.
Spectrometry
Maximum in water at ca 426 nm
B.
Yellow solution in water
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
4-aminobenzene-1-sulfonic acid
5-oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid
4,4′-diazoaminodi(benzene sulfonic acid)
Tetrahydroxysuccinic acid
Total not more than 0,5 %
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 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 104 QUINOLINE YELLOW
Synonyms
CI Food Yellow 13
Definition
Quinoline Yellow is prepared by sulfonating 2-(2-quinolyl) indan-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 sulfate as the principal uncoloured components.
Quinoline Yellow is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class
Chinophthalone
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
E1 cm 1 % 865 (principal component) at ca 411 nm in aqueous acetic acid solution
Description
Yellow powder or granules
Identification
A.
Spectrometry
Maximum in aqueous acetic acid solution of pH 5 at ca 411 nm
B.
Yellow solution in water
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
2-methylquinoline-sulfonic acid
Phthalic acid
2,6-dimethyl quinoline
2,6-dimethyl quinoline sulfonic acid
Total not more than 0,5 %
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 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 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
C16H10N2Na2O7S2
Molecular weight
452,37
Assay
Content not less than 85 % total colouring matters calculated as the sodium salt
E1 cm 1 % 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
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)
Total not more than 0,5 %
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, 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.
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 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 sulfate as the principal uncoloured components.
Azorubine is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class
Monoazo
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
E1 cm 1 % 510 at ca 516 nm in aqueous solution
Description
Red to maroon powder or granules
Identification
A.
Spectrometry
Maximum in water at ca 516 nm
B.
Red solution in water
Purity
Water insoluble matter
Not more than 0,2 %
Subsidiary colouring matters
Not more than 2,0 %
Organic compounds other than colouring matters:
4-aminonaphthalene-1-sulfonic acid
4-hydroxynaphthalene-1-sulfonic acid
Total not more than 0,5 %
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 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 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 sulfate as the principal uncoloured components.
Amaranth is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class
Monoazo
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
E1 cm 1 % 440 at ca 520 nm in aqueous solution
Description
Reddish-brown powder or granules
Identification
A.
Spectrometry
Maximum in water at ca 520 nm
B.
Red solution in water
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
3-hydroxynaphthalene-2,7-disulfonic acid
6-hydroxynaphthalene-2-sulfonic acid
7-hydroxynaphthalene-1,3-disulfonic acid
7-hydroxynaphthalene-1,3-6-trisulfonic acid
Total not more than 0,5 %
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 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 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 sulfate as the principal uncoloured components.
Ponceau 4R is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class
Monoazo
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.
E1 cm 1 % 430 at ca 505 nm in aqueous solution
Description
Reddish powder or granules
Identification
A.
Spectrometry
Maximum in water at ca 505 nm
B.
Red solution in water
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
7-hydroxynaphthalene-1,3-disulfonic acid
3-hydroxynaphthalene-2,7-disulfonic acid
6-hydroxynaphthalene-2-sulfonic acid
7-hydroxynaphthalene-1,3-6-trisulfonic acid
Total not more than 0,5 %
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 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 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 sulfate as the principal uncoloured components.
Erythrosine is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class
Xanthen
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
E1 cm 1 %1 100 at ca 526 nm in aqueous solution at pH 7
Description
Red powder or granules.
Identification
A.
Spectrometry
Maximum in water at ca 526 nm at pH 7
B.
Red solution in water
Purity
Inorganic iodides calculated as sodium iodide
Not more than 0,1 %
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-diodobenzoyl) 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 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
Aluminium Lakes
The hydrochloric acid insoluble matter method is not applicable. It is replaced by a sodium hydroxide insoluble matter, at not more than 0,5 %, for this colour only.
E 128 RED 2G
Synonyms
CI Food Red 10, Azogeranine
Definition
Red 2G consists essentially of disodium 8-acetamido-1-hydroxy-2-phenylazonaphthalene-3,6-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.
Red 2G is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class
Monoazo
Colour Index No
18050
Einecs
223-098-9
Chemical name
Disodium 8-acetamido-1-hydroxy-2-phenylazo-naphthalene-3,6-disulfonate
Chemical formula
C18H13N3Na2O8S2
Molecular weight
509,43
Assay
Content not less than 80 % total colouring matters, calculated as the sodium salt
E1 cm 1 % 620 at ca 532 nm in aqueous solution
Description
Red powder or granules
Identification
A.
Spectrometry
Maximum in water at ca 532 nm
B.
Red solution in water
Purity
Water insoluble matter
Not more than 0,2 %
Subsidiary colouring matters
Not more than 2,0 %
Organic compounds other than colouring matters:
5-acetamido-4-hydroxynaphthalene-2,7-disulfonic acid
5-amino-4-hydroxynaphthalene-2,7-disulfonic acid
Total not more than 0,5 %
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 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 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 sulfate as the principal uncoloured components.
Allura Red AC is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class
Monoazo
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
E1 cm 1 % 540 at ca 504 nm in aqueous solution at pH 7
Description
Dark red powder or granules
Identification
A.
Spectrometry
Maximum in water at ca 504 nm
B.
Red solution in water
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 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 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 sulfate and/or calcium sulfate as the principal uncoloured components.
The potassium salt is also permitted.
Class
Triarylmethane
Colour Index No
42051
Einecs
222-573-8
Chemical names
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: C27H31N2O7S2Ca
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
E1 cm 1 %2 000 at ca 638 nm in aqueous solution at pH 5
Description
Dark-blue powder or granules
Identification
A.
Spectrometry
Maximum in water at 638 nm at pH 5
B.
Blue solution in water
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
3-hydroxy benzoic acid
3-hydroxy-4-sulfobenzoic acid
N,N-diethylamino benzene sulfonic acid
Total not more than 0,5 %
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 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 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 sulfate as the principal uncoloured components.
Indigotine is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class
Indigoid
Colour Index No
73015
Einecs
212-728-8
Chemical names
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 %
E1 cm 1 % 480 at ca 610 nm in aqueous solution
Description
Dark-blue powder or granules
Identification
A.
Spectrometry
Maximum in water at ca 610 nm
B.
Blue solution in water
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
5-sulfoanthranilic acid
Anthranilic acid
Total not more than 0,5 %
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 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 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 sulfate as the principal uncoloured components.
Brilliant Blue FCF is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class
Triarylmethane
Colour Index No
42090
Einecs
223-339-8
Chemical names
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
E1 cm 1 %1 630 at ca 630 nm in aqueous solution
Description
Reddish-blue powder or granules
Identification
A.
Spectrometry
Maximum in water at ca 630 nm
B.
Blue solution in water
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 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 140 (i) CHLOROPHYLLS
Synonyms
CI Natural Green 3, Magnesium Chlorophyll, Magnesium Phaeophytin
Definition
Chlorophylls are obtained by solvent extraction of natural strains of edible plant material, grass, lucerne and nettle. During the subsequent removal of solvent, the naturally present co-ordinated 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.
Class
Porphyrin
Colour Index No
75810
Einecs
Chlorophylls: 215-800-7, chlorophyll a: 207-536-6, Chlorophyll b: 208-272-4
Chemical names
The major colouring principles are:
Phytyl (132 R,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, (Pheophytin a), or as the magnesium complex (Chlorophyll a)
Phytyl (132 R,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 %
E1 cm 1 % 700 at ca 409 nm in chloroform
Description
Waxy solid ranging in colour from olive green to dark green depending on the content of co-ordinated magnesium
Identification
Spectrometry
Maximum in chloroform at ca 409 nm
Purity
Solvent residues
Acetone
Methyl Ethyl ketone
Methanol
Ethanol
Propan-2-ol
Hexane
Not more than 50 mg/kg, singly or in combination
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
Heavy metals (as Pb)
Not more than 40 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 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. 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
287-483-3
Chemical names
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.
E1 cm 1 % 700 at ca 405 nm in aqueous solution at pH 9
E1 cm 1 % 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
Methyl ethyl ketone
Methanol
Ethanol
Propan-2-ol
Hexane
Not more than 50 mg/kg, singly or in combination
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
Heavy metals (as Pb)
Not more than 40 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 natural 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.
Class
Porphyrin
Colour Index No
75815
Einecs
Copper chlorophyll a: 239-830-5; copper chlorophyll b: 246-020-5
Chemical names
[Phytyl (132 R,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 (132 R,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 %.
E1 cm 1 % 540 at ca 422 nm in chloroform
E1 cm 1 % 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
Methyl ethyl ketone
Methanol
Ethanol
Propan-2-ol
Hexane
Not more than 50 mg/kg, singly or in combination
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 phaeophytins
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:
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.
E1 cm 1 % 565 at ca 405 nm in aqueous phosphate buffer at pH 7,5
E1 cm 1 % 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 ca 630 nm
Purity
Solvent residues
Acetone
Methyl ethyl ketone
Methanol
Ethanol
Propan-2-ol
Hexane
Not more than 50 mg/kg, singly or in combination
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 142 GREEN S
Synonyms
CI Food Green 4, Brilliant Green BS
Definition
Green S consists essentially of sodium N-[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.
Class
Triarylmethane
Colour Index No
44090
Einecs
221-409-2
Chemical names
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
E1 cm 1 %1 720 at ca 632 nm in aqueous solution
Description
Dark blue or dark green powder or granules
Identification
A.
Spectrometry
Maximum in water at ca 632 nm
B.
Blue or green solution in water
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 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 150a PLAIN 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 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 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
Heavy metals (as Pb)
Not more than 25 mg/kg
E 150b CAUSTIC SULPHITE CARAMEL
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 intensity (1)
0,05-0,13
Total nitrogen
Not more than 0,3 % (2)
Sulphur dioxide
Not more than 0,2 % (2)
Total sulphur
0,3-3,5 % (2)
Sulphur bound by DEAE cellulose
More than 40 %
Absorbance ratio of colour bound by DEAE cellulose
19-34
Absorbance ratio
(A 280/560)
Greater than 50
Arsenic
Not more than 1 mg/kg
Lead
Not more than 2 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 25 mg/kg
E 150c AMMONIA CARAMEL
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 intensity (1)
0,08-0,36
Ammoniacal nitrogen
Not more than 0,3 % (2)
4-methylimidazole
Not more than 250 mg/kg (2)
2-acetyl-4-tetrahydroxy-butylimidazole
Not more than 10 mg/kg (2)
Total sulphur
Not more than 0,2 % (2)
Total nitrogen
0,7-3,3 % (2)
Absorbance ratio of colour bound by phosphoryl cellulose
13-35
Arsenic
Not more than 1 mg/kg
Lead
Not more than 2 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 25 mg/kg
E 150d SULPHITE AMMONIA CARAMEL
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 intensity (1)
0,10-0,60
Ammoniacal nitrogen
Not more than 0,6 % (2)
Sulphur dioxide
Not more than 0,2 % (2)
4-methylimidazole
Not more than 250 mg/kg (2)
Total nitrogen
0,3-1,7 % (2)
Total sulphur
0,8-2,5 % (2)
Nitrogen/sulphur ratio of alcohol precipitate
0,7-2,7
Absorbance ratio of alcohol precipitate (3)
8-14
Absorbance ratio (A 280/560)
Not more than 50
Arsenic
Not more than 1 mg/kg
Lead
Not more than 2 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 25 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 sulfate as the principal uncoloured components.
Brilliant Black BN is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class
Bisazo
Colour Index No
28440
Einecs
219-746-5
Chemical names
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
E1 cm 1 % 530 at ca 570 nm in solution
Description
Black powder or granules
Identification
A.
Spectrometry
Maximum in water at ca 570 nm
B.
Black-bluish solution in water
Purity
Water insoluble matter
Not more than 0,2 %
Subsidiary colouring matters
Not more than 10 % (expressed on the dye content)
Organic compounds other than colouring matters:
4-acetamido-5-hydroxynaphthalene-1,7-disulfonic acid
4-amino-5-hydroxynaphthalene-1,7-disulfonic acid
8-aminonaphthalene-2-sulfonic acid
4,4′-diazoaminodi-(benzenesulfonic acid)
Total not more than 0,8 %
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 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 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 carbonised 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 1 000 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
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 sulfate as the principal uncoloured components.
Brown HT is described as the sodium salt. The calcium and potassium salt are also permitted.
Class
Bisazo
Colour Index No
20285
Einecs
224-924-0
Chemical names
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.
E1 cm 1 % 403 at ca 460 nm in aqueous solution at pH 7
Description
Reddish-brown powder or granules
Identification
A.
Spectrometry
Maximum in water of pH 7 at ca 460 nm
B.
Brown solution in water
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 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 160a (i) MIXED CAROTENES
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 (4), dichloromethane and carbon dioxide.
Class
Carotenoid
Colour Index No
75130
Einecs
230-636-6
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.
E1 cm 1 %2 500 at approximately 440 nm to 457 nm in cyclohexane
Identification
Spectrometry
Maximum in cyclohexane at 440 nm to 457 nm and 470 nm to 486 nm
Purity
Solvent residues
Acetone
Methyl ethyl ketone
Methanol
Propan-2-ol
Hexane
Ethanol
Not more than 50 mg/kg, singly or in combination
Dichloromethane: Not more than 10 mg/kg
Lead
Not more than 5 mg/kg
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: C40H56
Molecular weight
Beta-Carotene: 536,88
Assay
Content of carotenes (calculated as beta-carotene) is not less than 20 %
E1 cm 1 %2 500 at approximately by 440 nm to 457 nm in cyclohexane
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 5 mg/kg
E 160a (ii) BETA-CAROTENE
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.
Class
Carotenoid
Colour Index No
40800
Einecs
230-636-6
Chemical names
Beta-carotene, beta, beta-carotene
Chemical formula
C40H56
Molecular weight
536,88
Assay
Not less than 96 % total colouring matters (expressed as beta-carotene)
E1 cm 1 %2 500 at approximately by 440 nm to 457 nm in cyclohexane
Description
Red to brownish-red crystals or crystalline powder
Identification
Spectrometry
Maximum in cyclohexane at 453 nm to 456 nm
Purity
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
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
C40H56
Molecular weight
536,88
Assay
Not less than 96 % total colouring matters (expressed as beta-carotene)
E1 cm 1 %2 500 at approximately 440 nm to 457 nm in cyclohexane
Description
Red, brownish-red or purple-violet crystals or crystalline powder (colour varies according to extraction solvent used and conditions of crystallisation)
Identification
Spectrometry
Maximum in cyclohexane at 453 nm to 456 nm
Purity
Solvent residues
Ethyl acetate
Ethanol
Not more than 0,8 %, singly or in combination
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 160b ANNATTO, BIXIN, NORBIXIN
Synonyms
CI Natural Orange 4
Definition
Class
Carotenoid
Colour Index No
75120
Einecs
Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7
Chemical names
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
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
Solvent extracted bixin and norbixin
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.
Assay
Content of bixin powders not less than 75 % total carotenoids calculated as bixin.
Content of norbixin powders not less than 25 % total carotenoids calculated as norbixin
Bixin
:
E1 cm 1 %2 870 at ca 502 nm in chloroform
Norbixin
:
E1 cm 1 %2 870 at ca 482 nm in KOH solution
Purity
Solvent residues
Acetone
Methanol
Hexane
not more than 50 mg/kg, singly or in combination
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
Heavy metals (as Pb)
Not more than 40 mg/kg
Alkali extracted annatto
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.
Assay
Contains not less than 0,1 % of total carotenoids expressed as norbixin
Norbixin
:
E1 cm 1 %2 870 at ca 482 nm in KOH solution
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
Oil extracted annatto
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 transforms. Thermal degradation products of bixin may also be present.
Assay
Contains not less than 0,1 % of total carotenoids expressed as bixin
Bixin
:
E1 cm 1 %2 870 at ca 502 nm in chloroform
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 160c PAPRIKA EXTRACT, CAPSANTHIN, CAPSORUBIN
Synonyms
Paprika Oleoresin
Definition
Paprika extract is obtained by solvent extraction of the natural 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 and carbon dioxide.
Class
Carotenoid
Einecs
Capsanthin: 207-364-1, capsorubin: 207-425-2
Chemical names
Capsanthin: (3R, 3′S, 5′R)-3,3′-dihydroxy-β,k-carotene-6-one
Capsorubin: (3S, 3′S, 5R, 5R′)-3,3′-dihydroxy-k,k-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
E1 cm 1 %2 100 at ca 462 nm in acetone
Description
Dark-red viscous liquid
Identification
A.
Spectrometry
Maximum in acetone at ca 462 nm
B.
Colour reaction
A deep blue colour is produced by adding one drop of sulfuric acid to one drop of sample in 2-3 drops of chloroform
Purity
Solvent residues
Ethyl acetate
Methanol
Ethanol
Acetone
Hexane
Not more than 50 mg/kg, singly or in combination
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 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 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, ψ,ψ-carotene
Chemical formula
C40H56
Molecular weight
536,85
Assay
Content not less than 5 % total colouring matters
E1 cm 1 %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
Methanol
Ethanol
Acetone
Hexane
Propan-2-ol
Not more than 50 mg/kg, singly or in combination
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
E1 cm 1 %2 640 at ca 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
Heavy 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
Carotenoid
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
E1 cm 1 %2 550 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
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 161b LUTEIN
Synonyms
Mixed Carotenoids, Xanthophylls
Definition
Lutein is obtained by solvent extraction of the natural 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, dichloromethane and carbon dioxide
Class
Carotenoid
Einecs
204-840-0
Chemical names
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
E1 cm 1 %2 550 at ca 445 nm in chloroform/ethanol (10 + 90) or in hexane/ethanol/acetone (80 + 10 + 10)
Description
Dark, yellowish brown liquid
Identification
Spectrometry
Maximum in chloroform/ethanol (10 + 90) at ca 445 nm
Purity
Solvent residues
Acetone
Methyl ethyl ketone
Methanol
Ethanol
Propan-2-ol
Hexane
Not more than 50 mg/kg, singly or in combination
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
Heavy metals (as Pb)
Not more than 40 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 stabilized 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.
Class
Carotinoid
Colour Index No
40850
Einecs
208-187-2
Chemical names
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)
E1 cm 1 %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
Sulfated 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 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 162 BEETROOT RED, BETANIN
Synonyms
Beet Red
Definition
Beet red is obtained from the roots of natural 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.
Class
Betalaine
Einecs
231-628-5
Chemical names
(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 %
E1 cm 1 %1 120 at ca 535 nm in aqueous solution at pH 5
Description
Red or dark red liquid, paste, powder or solid
Identification
Spectrometry
Maximum in water of pH 5 at ca 535 nm
Purity
Nitrate
Not more than 2 g nitrate anion/g of red colour (as calculated from assay).
Arsenic
Not more than 3 mg/kg
Lead
Not more than 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 163 ANTHOCYANINS
Definition
Anthocyanins are obtained by extraction with sulphited water, acidified water, carbon dioxide, methanol or ethanol from the natural strains of vegetables and edible fruits. 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.
Class
Anthocyanin
Einecs
208-438-6 (cyanidin); 205-125-6 (peonidin); 208-437-0 (delphinidin); 211-403-8 (malvidin); 205-127-7 (pelargonidin)
Chemical names
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
E1 cm 1 % 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
Ethanol
Not more than 50 mg/kg, singly or in combination
Sulfur dioxide
Not more than 1 000 mg/kg per percent pigment
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 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)
Copper (as Cu)
Chromium (as Cr)
Zinc (as Zn)
Barium (as Ba)
Not more than 100 mg/kg, singly or in combination
Arsenic
Not more than 3 mg/kg
Lead
Not more than 10 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.
Class
Inorganic
Colour Index No
77891
Einecs
236-675-5
Chemical names
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 sulfuric 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
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
Zink
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 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.
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)·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 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 7,0 %
After complete dissolution
Copper
Not more than 4,0 %
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 sulfate as the principal uncoloured components.
Class
Monoazo
Colour Index No
15850:1
Einecs
226-109-5
Chemical names
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
E1 cm 1 % 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 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
(1) Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm.
(2) Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units.
(3) Absorbance ratio of alcohol precipitate is defined as the absorbance of the precipitate at 280 nm divided by the absorbance at 560 nm (1 cm cell).
(4) Benzene not more than 0,05 % v/v.
ANNEX II
PART A
Repealed Directive with list of its successive amendments
(referred to in Article 2)
Commission Directive 95/45/EC
(OJ L 226, 22.9.1995, p. 1)
Commission Directive 1999/75/EC
(OJ L 206, 5.8.1999, p. 19)
Commission Directive 2001/50/EC
(OJ L 190, 12.7.2001, p. 14)
Commission Directive 2004/47/EC
(OJ L 113, 20.4.2004, p. 24)
Commission Directive 2006/33/EC
(OJ L 82, 21.3.2006, p. 10)
PART B
List of time-limits for transposition into national law
(referred to in Article 2)
Directive
Time-limit for transposition
95/45/EC
1 July 1996 (1)
1999/75/EC
1 July 2000
2001/50/EC
29 June 2002
2004/47/EC
1 April 2005 (2)
2006/33/EC
10 April 2007
(1) According to Article 2(2) of Directive 95/45/EC, products put on the market or labelled before 1 July 1996 which do not comply with that Directive may, however, be marketed until stocks are exhausted.
(2) According to Article 3 of Directive 2004/47/EC, products on the market or labelled before 1 April 2005 which do not comply with that Directive may be marketed until stocks are exhausted.
ANNEX III
Correlation table
Directive 95/45/EC
This Directive
Article 1, first paragraph
Article 1
Article 1, second paragraph
—
Article 2
—
—
Article 2
Article 3
Article 3
Article 4
Article 4
Annex
Annex I
—
Annex II
—
Annex III