No C 278/4 Official Journal of the European Communities 30.10. 85 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Directive amending for the eighth time the 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 
COM(85) 474 final 
(Submitted by the Commission to the Council on 30 September 1985) 
(85/C 278/04) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100 
thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European 
Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas 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 ('), as last 
amended by Directive 81/20/EEC (2), lays down in 
Annex II lists of colouring matters and substances used 
for diluting and dissolving colouring matters which may 
be authorized at national level by the Member States; 
Whereas, having regard to the most recent scientific and 
toxicological information on these substances, with the 
exception of Yellow 2G it is possible to authorize the use 
of substances in the said Annex II within the 
Community; whereas, also, this information makes it 
possible to introduce into the Directive the colouring 
matter Allura Red AC; 
Whereas, in the light of present-day requirements 
regarding the safety in use of colouring matters, Yellow 
2G should no longer be permitted for use in foodstuffs; 
Whereas the prohibition so required should be given 
effect under conditions which ensure the protection of 
public health while avoiding as far as possible disruption 
of a technological and economic nature; 
C) OJ No 115, 11. 11. 1962, p. 2645/62. 
O OJNoL43, 14.2. 1981, p. 11. Whereas decisions should now be taken on the har­
monization of the conditions governing the colouring of 
foodstuffs in the case of Brown FK, Red 2G, 
carrageenan (E 407) and gum arabic (E 414); 
Whereas the authorization of colouring matters should 
be associated with the laying down of criteria of purity 
which these colouring matters should satisfy; whereas, in 
the light of scientific research, it is desirable that for the 
protection of public health the criteria of purity for the 
colouring matters authorized at Communtiy level should 
be revised; 
Whereas this revision incorporates a re-examination of 
the nomenclature used to identify colouring matters in 
the Directive, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
The Directive of 23 October 1962 is hereby amended as 
follows: 
1. The following substances are added to the list in 
Article 6: 
'ethyl acetate, diethyl ether, glycerol monoacetate, 
glycerol diacetate, isopropyl alcohol, propane-1,2,-
diol, acetic acid, sodium hydroxide, ammonium 
hydroxide and, exclusively for the colouring matters 
listed under number E 160 and E 161 in Annex I, 
carrageenan and gum arabic'. 
2. Article 8 is replaced by the following: 
Article 8 
Member States shall take all measures necessary to 
ensure that the colouring matters listed in Annex I 
and the products listed in Article 6, where these are 
used to dilute or dissolve the colouring matters listed 
in Annex I, satisfy the general and specific criteria laid 
down in Annex III.' 
30.10. 85 Official Journal of the European Communities No C 278/5 
3. The first indent of Article 11 (2) is replaced by the 
following: 
'— the methods of analysis needed to verify that the 
general and specific criteria of purity laid down in 
Annex III are satisfied, where these are not 
already specified in the relevant purity criteria 
referred to in Annex III, and the modifications, 
where necessary, to methods specified in the 
purity criteria in question'. 
4. Annex I is replaced in accordance with Annex 1 
hereto. 
5. Annex II is deleted. 
6. Annex III is replaced in accordance with Annex 2 
hereto. Article 2 
The marketing of foods containing Yellow 2G shall be 
prohibited as from [date: 18 months after notification]. 
Article 3 
Member States shall bring into force the laws, regu­
lations and administrative provisions necessary to comply 
with this Directive not later than 12 months after 
notification and shall forthwith inform the Commission 
thereof. 
Article 4 
This Directive is addressed to the Member States. 
ANNEX I 
'ANNEX 1 
The colouring matters referred to in Article 1 of this Directive are listed in the three sections below. 
Aluminium lakes prepared from these colouring matters are also authorized. 
The chemical name given is usually that of the sodium derivative of the colouring matter. The free acid 
form of the dye and its potassium and calcium salt may be present, although for the purposes of calculating 
the limits in the purity criteria these are calculated as the equivalent sodium derivative. 
EEC No Common name Colour index number (') and name, or chemical description 
(1) Colouring 
E 100 
E 101 
E 102 
E 104 
E 110 
E 120 
E 122 
E 123 
E 124 
E 127 
E 129 
E 131 
E 132 
E 133 
E 140 
E 141 matters for both mass and surface colouring 
Curcumin 
(i) Riboflavin 
(ii) Riboflavin-5'-phosphate 
Tartrazine 
Quinoline yellow 
Sunset yellow FCF 
Orange yellow S 
Cochineal/Carminic acid/Carmines 
Azorubine 
Carmoisine 
Amaranth 
Ponceau 4R 
Cochineal red A 
Erythrosine 
Allura red AC 
Patent blue V 
Indigotine 
Indigo carmine 
Brilliant blue FCF 
Chlorophylls and chlorophyllins 
(i) chlorophylls 
(ii) chlorophyllins 
Copper complexes of chlorophylls and 
chlorophyllins 
(i) copper complexes of chlorophylls 
(ii) copper complexes of chlorophyllins 75300 (Natural yellow 3) 
19140 (Food yellow 4) 
47005 (Food yellow 13) 
15985 (Food yellow 3) 
75470 (Natural red 4) 
14720 (Food red 3) 
16185 (Food red 9) 
16255 (Food red 7) 
45430 (Food red 14) 
16035 (Food red 17) 
42051 (Food blue 5) 
73015 (Food blue 1) 
42090 (Food blue 2) 
75810 (Natural green 3) 
75815 (Natural green 5) 
75815 (Natural green 5) 
No C 278/6 Official Journal of the European Communities 30.10.85 
EEC No 
E142 
E150a 
E 150 b 
E 150 c 
E 150 d 
E 151 
E 153 
E 155 
E 160 a 
E 160 b 
E160c 
E 160 d 
E 160 e 
E 160 f 
E 161 
E 161 b 
E 161 c 
E 161 d 
E 161 e 
E 161 f 
E 161 g 
E 162 
E 163 
E 171 
E 172 Common name 
Green S 
Plain (spirit) caramel 
Caustic sulphite caramel 
Ammonia caramel 
Sulphite ammonia caramel 
Brilliant black PN, Black PN 
Vegetable carbon 
Brown HT 
(i) Mixed carotenes 
(ii) Beta-carotene 
Annatto extracts 
Paprika extract 
(deleted) 
Beta-apo-8'-carotenal (C 30) 
Ethyl ester of Beta-apo-8'-carotenic acid 
(C30) 
Xanthophylls 
(deleted) 
(deleted) 
(deleted) 
(deleted) 
(deleted) 
Canthaxanthin 
Beetroot red 
Anthocyanins 
Titanium dioxide 
Iron oxides and hydroxides Colour index number (') and name, 
or chemical description 
44090 (Food green 4) 
Caramel (2) prepared by the controlled heat 
treatment of carbohydrates with or without 
the presence of alkali or acid 
Caramel prepared by the controlled heat 
treatment or carbohydrates with sulphite-
containing compounds 
Caramel prepared by the controlled heat 
treatment of carbohydrates with ammonia 
Caramel prepared by the controlled heat 
treatment of carbohydrates with ammonium 
and sulphite-containing compounds 
28440 (Food black 1) 
20285 (Food brown 3) 
75130 (Food orange 5) 
40800 (Food orange 5) 
75120 (Natural orange 4) 
40820 (Food orange 6) 
40825 (Food orange 7) 
Prepared by physical means from natural 
foods 
40850 (Food orange 8) 
Prepared by physical means from edible 
fruits and vegetables 
77891 (Pigment white 6) 
77491, 77492, 77499 (Pigment yellow 42 and 
43, Pigment red 101 and 102, Pigment black 
11) 
(2) Colouring matters for surface colouring only 
E 170 
E 173 
E 174 
E 175 Calcium carbonate 
Aluminium 
Silver 
Gold 77220 
77000 (Pigment metal 1) 
(3) Colouring 
E 128 
E 154 
E 180 matters for certain uses only 
Red2G 
(not for use in foodstuffs subject to high 
temperature during processing, nor in 
products of high acidity) 
Brown FK 
(for cured fish only) 
Lithol Rubine BK 
(for cheese rind only) 18050 (Food red 10) 
15851:1 
(Pigment red 57:1) 
(') Colour index figures are taken from the 3rd edition 1982, volumes 1-7, 1315. Also amendments 37-40 (125), 41-44 
(127-50), 45-48 (130), 49-52 (132-50), 53-56 (135). 
(2) The term "caramel" relates to products of a more or less intense brown colour which are intended for colouring. It 
does not correspond to the sugary aromatic product obtained from heating sugar and which is used for flavouring 
food (e.g. confectionery, pastry).' 
30.10. 85 Official Journal of the European Communities No C 278/7 
ANNEX III 
'ANNEX 2 
CRITERIA OF PURITY 
A. GENERAL CRITERIA OF PURITY 
1. Colouring matters and substances for diluting or dissolving colouring matters 
They shall not contain a toxicologically dangerous amount of any element. 
Arsenic (total): not more than 3 mg/kg. 
Lead (total): not more than 10 mg/kg. 
Mercury (total): not more than 1 mg/kg. 
Heavy metals (total): not more than 40 mg/kg. 
2. Aluminium lakes of colouring matters 
Definition: 
Aluminium lakes are prepared by reacting colouring matter complying with the purity criteria set out in 
the appropriate specification monograph with alumina under aqueous conditions. The alumina is usually 
freshly prepared undried material made by reacting aluminium sulphate or chloride with sodium 
carbonate or bicarbonate or ammonia. Following lake formation, the product is filtered, washed with 
water, and dried. 
Water soluble chloride and sulphate 
(calculated as sodium salts): not more than 2 %. 
HCL insoluble matter: not more than 0,5 %. 
Ether extractable matter: not more than 0,2 %. 
Arsenic (total): not more than 3 mg/kg. 
Lead (total): not more than 10 mg/kg. 
Mercury (total): not more than 1 mg/kg. 
Heavy metals (total): not more than 40 mg/kg. 
B. SPECIFIC CRITERIA OF PURITY 
E 100 Curcumin 
Chemical description: 
Curcumin consists essentially of the pure colouring principle (l,7-bis(4 hydrox-3-methoxyphenyl)hepta-l,6 
diene-3,5-dione). 
Curcumin is obtained by solvent extraction of turmeric, which consists of the ground rhizomes of Curcuma 
longa L. It may contain other compounds such as di-desmethoxy derivatives. 
Solvents used are: methanol, hexane, and acetone. 
Content: 
The concentrated curcumin contains not less than 90 % of total curcumins by absorption at 425 nm in 
ethanol. 
Colour intensity: 
E .„r =1 607 in ethanol, 1 cm-layer, for pure curcumin. 
425 nm ' r 
Solvent residues: 
Methanol: 1 
Hexane: > not more than 50 mg/kg singly or in combination. 
Acetone: 
No C 278/8 Official Journal of the European Communities 30.10.85 
E 101 (i) Riboflavin 
Riboflavin shall comply with the monograph for riboflavin contained in FAO Food and Nutrition Paper 
No 31/1, p. 123 
The substance shall also comply with the following: 
Primary aromatic amines: 
Not more than 100 mg/kg calculated as aniline. 
E 101 (ii) Riboflavin-5'-phosphate 
Riboflavin-5'-phosphate shall comply with the monograph for riboflavin-5'-phosphate sodium contained in 
FAO Food and Nutrition Paper No 31/1, p. 127, with the following exception: 
Assay (content): 
not less than 70 % and not more than 75 % of total (free and esterified) riboflavin calculated as riboflavin 
determined by fluorescence. 
The substance shall also comply with the following: 
Chemical description: 
Riboflavin-5'-phosphate consists mainly of the monosodium salt of the 5'-monophosphate ester of riboflavin 
dihydrate. 
Primary aromatic amines (calculated as aniline): 
not more than 70 mg/kg. 
ph of a 1 % weight/volume solution: 
not less than 5,0 and not more than 6,5. 
E 102 Tartrazine 
Tartrazine shall comply with the monograph for Tartrazine contained in FAO Food and Nutrition Paper 
No 31/1, p. 133. 
E 104 Quinoline yellow 
Quinoline yellow shall comply with the monograph for Quinoline yellow contained in FAO Food and 
Nutrition Paper No 31/1, p. 117, with the following exceptions: 
Limit figure for subsidiary colouring matters should read: 
"not more than 1 °/o" 2-(2-quinolyl)indan-l,3 dione and 2-(2-(6-methylquinolyl))indan-l,3-dione: not 
more than 4 mg/kg. 
E 110 Sunset yellow S 
Sunset yellow S shall comply with the monograph for Sunset yellow FCF contained in FAO Food and 
Nutrition Paper No 31 /1, p. 131. 
E 120 Cochineal/Carminic acid/Carmines 
Carmines of cochineal shall comply with the monograph for Carmines contained in FAO Food and 
Nutrition Paper No 25, p. 60; Cochineal and Carminic acid shall comply with the monograph for 
Cochineal and Carminic acid contained in FAO Food and Nutrition Paper No 31/1, p. 63. 
E 122 Azorubine 
Azorubine shall comply with the monograph for Azorubine contained in FAO Food and Nutrition Paper 
No 31/1, p. 21. 
E 123 Amaranth 
Amaranth shall comply with the monograph for Amaranth contained in FAO Food and Nutrition Paper 
No 31/1, p. 9. 
30.10. 85 ' Official Journal of the European Communities No C 278/9 
E 124 Ponceau 4R 
Ponceau 4R shall comply with the monograph for Ponceau 4R contained in FAO Food and Nutrition 
Paper No 31/1, p. 115, with the following exceptions: 
Assay (content): 
not less than 70 % total colouring matters. 
Loss on drying at 135 °C: 
not more than 30 %. 
Chloride and sulphate (calculated as sodium salts): 
not more than 30 %. 
E 127 Erythrosine 
Erythrosine shall comply with the monograph for Erythrosine contained in FAO Food and Nutrition Paper 
No 31/1, p. 71. 
E 128 Red 2G 
Red 2G shall comply with the monograph for Red 2G in FAO Food and Nutrition Paper No 31/1, p. 121. 
El 29 AlluraredAC 
Allura red AC shall comply with the monograph for Allura red AC contained in FAO Food and Nutrition 
Paper No 31/1, p. 3. 
E131 Patent blue V 
Patent blue V shall comply with the monograph for Patent blue V contained in FAO Food and Nutrition 
Paper No 31/1, p. 111. 
E 132 Indigotine 
Indigotine shall comply with the monograph for Indigotine contained in FAO Food and Nutrition Paper 
No 31/1, p. 95. 
E 133 Brilliant blue FCF 
Brilliant blue FCF shall comply with the monograph for Brilliant blue FCF in FAO Food and Nutrition 
Paper No 31/1, p. 31. 
E 140 Chlorophylls and chlorophyllins 
(i) Chlorophylls 
(ii) Chlorophyllins 
(i) Chlorophylls shall comply with the monograph for chlorophylls in FAO Food and Nutrition Paper No 
31/1, p. 57, with the following exceptions: 
Content (assay): 
not less than 10 % of total phaeophytins and complexes of phaeophytins determined and calculated as 
phaeophytin a, which may be in solution in any type of edible vegetable oil. 
No C 278/10 Official Journal of the European Communities 30.10.85 
1 % E « at 409 nm = not less than 70 (in CHCh). 1 cm *" 
Definition: 
Chlorophylls are obtained by solvent extraction of chlorophyll from grass, nettles, lucerne or other edible 
plants, followed by removal of the solvent with or without subsequent removal of magnesium from the 
complexes. Only the following solvents may be used: 
acetone, ethanol, light petroleum, methyl ethyl ketone and dichloromethane. Chlorophylls may also 
contain other pigments and other substances such as oils, fats and waxes derived from the source material. 
Description: 
Waxy solids, ranging from olive green to dark green. 
The materials shall also comply with the following: 
Solvent residues: 
acetone 
ethanol 
light petroleum 
methanol 
methyl ethyl ketone 
dichloromethane 
propan-2-ol Not more than 50 mg/kg singly or in combination. 
Ionic copper (as Cu): Not more than 50 mg/kg related to 10 % total phaeophytins. 
(ii) Chlorophyllins 
Chemical description: 
Chlorophyllins are obtained by the saponification of chlorophyll obtained by solvent extraction from grass, 
lucerne, other edible plants, e.g. nettle, with or without the addition of copper. 
The major colouring principles are normally disodium, dipotassium or sodium potassium 3-(10-car-
boxylato-4-ethyl-l,3,5,8-tetramethyl'9-oxo-2-vinylphorbin-7-yl) propionate (chlorophyllin a) and diso­
dium, dipotassium or sodium potassium 3-(10-carboxylato-4-ethyl-3-formyl-l,5,8-trimethyl-9-oxo-2-
vinylphorbin-7-yl) propionate (chlorophyllin b), present either as such or in the form of the magnesium or 
copper complexes, although monosodium and/or monopotassium salts may also be present, depending on 
the degree of hydrolysis, and in some products the isocyclic ring may be cleaved with the resultant 
production of tribasic sodium, potassium or sodium potassium salts. Chlorophyllins also contain other 
pigments, which in coppered products may be present as the copper derivatives, and other substances such 
as the sodium or potassium salts of fatty acids, derived directly or indirectly from the source material. 
Solvents used are the following: acetone, chloroform, dichloromethane, ethanol, light petroleum, methyl 
ethyl ketone, methanol and propanol-2-ol. 
E 141 Copper complexes of chlorophylls and chlorophyllins 
(i) Copper chlorophylls, formed by the replacement of all or part of the magnesium of uncoppered 
chlorophylls by copper, shall comply with the purity criteria for chlorophylls, with the following 
exceptions: 
Content (assay): 
1 % E . at 422 nm = not less than 54 (in CHCI3). 
Free ionic copper (as Cu): 
not more than 200 mg/kg. 
Total copper: 
not more than 8 000 mg/kg related to 10 % total phaetophytines. 
(ii) Copper complexes of chlorophyllins 
Chemical description: 
Chlorophyllins are obtained by the saponification of chlorophyll exctracts obtained by solvent extraction 
from grass, nettle, lucerne, other edible plants with the addition of copper. 
The major colouring principles are normally disodium, dipotassium or sodium potassium 3-(10-car-
boxylato-4-ethyl-l,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl) propionate (chlorophyllin a) and diso-
30.10.85 Official Journal of the European Communities No C 278/11 
dium, dipotassium or sodium potassium 3-(10-carboxylato-4-ethyl-3-formyl-l,5,8-trimethyl-9-oxo-2-
vinylphorbin-7-yl) propionate (chlorophyllin b), present in the form of copper complexes, although 
monosodium and/or monopotassium salts may also be present, depending on the degree of hydrolysis, and 
in some products the isocyclic ring may be cleaved with the resultant production of tribasic sodium, 
potassium or sodium potassium salts. Chlorophyllins also contain other pigments which may be present as -
the copper derivatives, and other substances such as the sodium or potassium salts of fatty acids, derived 
directly or indirectly from the source material. 
Solvents used are the following: acetone, dichloromethane, ethanol, light petroleum, methyl ethyl ketone, 
methanol and propanol-2-ol. 
Free ionic copper (as Cu): 
not more than 200 mg/kg. 
Total copper: 
not more than 8 000 mg/kg. 
E 142 Green S 
Green S shall comply with the monograph for Green S contained in FAO Food and Nutrition Paper No 
31/1, p. 91. 
E 150 Caramel 
Description: 
Caramel colours are dark brown to black liquids or solids, having an odour of burnt sugar and a pleasant, 
somewhat bitter taste. They are 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, 
food-grade acids, alkalis and salts may be employed. 
The following sulphite compounds are also used in the preparation of caustic sulphite caramel (E 150 b) 
and sulphite ammonia caramel (E 150 d): sulphurous acid and potassium, sodium and ammonium sulphites 
and bisulphites. 
The following ammonium compounds are also used in the preparation of ammonia caramel (E 150 c) and 
sulphite ammonia caramel (E 150 d): ammonium hydroxide, carbonate, bicarbonate phosphate and 
sulphate and, for E 150 d, ammonium sulphite and bisulphite. 
Specific requirements for individual caramels 
(i) E 150 a 
Colour bound by DEAE cellulose: 
not more than 50 %. 
Colour bound by phosphoryl cellulose: 
not more than 50 %. 
Colour intensity ('): 
0,01 to 0,14. 
Total nitrogen: 
not more than 0,1 % (*). 
Total sulphur: 
not more than 0,2 % (*). 
(ii) E 150 b 
Colour bound by DEAE cellulose: 
more than 50 %. 
Colour intensity: 
0,05 to 0,13. 
Total nitrogen: 
not more than 0,3 % (*). 
(') Colour intensity is defined as the absorbance of a 0 to 1 % (w/v) solution of caramel colour solids in 
water in a 1 cm cell at 610 nm. 
(*) Expressed on equivalent colour basis. 
No C 278/12 Official Journal of the European Communities 30.10.85 
Sulphur dioxide: 
not more than 0,2 % (?). 
Total sulphur: 
1,0 to 3,5 % (»). 
Sulphur hound by DEAE cellulose ('): 
more than 40 %. 
Absorbance ratio of colour bound by DEAE cellulose (2): 
19 to 34. 
Absorbance ratio (A 280/560): 
greater than 50. 
(iii) E 150 c 
Colour bound by DEAE cellulose: 
more than 50 %. 
Colour bound by phosphoryl cellulose: 
more than 50 °/o. 
Colour intensity: 
0,08 to 0,36. 
Ammoniacal nitrogen: 
not more than 0,3 % (*). 
4-methylimidazole: 
not more than 250 mg/kg (*). 
2-acetyl-4-tetrahydroxy-butylimidazole: 
not more than 25 mg/kg (*). 
Total sulphur: 
not more than 0,2 % (*). 
Total nitrogen: 
0,7 to 3,3 % (*). 
Absorbance ratio of colour bound by phosphoryl cellulose (J): 
13 to 35. 
(iv) El50d 
Colour bound by DEAE cellulose: 
more than 50 %. 
Colour intensity: 
0,10 to 0,60. 
Ammoniacal nitrogen: 
not more than 0,6 % (*). 
Sulphur dioxide: 
not more than 0,2 % (*). 
(*) Expressed on equivalent colour basis. 
(*) Sulphur bound by DEAE cellulose is defined as the percentage of decrease in total sulphur content 
after treatment with DEAE cellulose. 
(2) Absorbance ratio of colour bound by DEAE cellulose is defined as the absorbance of the colour bound 
by DEAE cellulose at 280 nm divided by the absorbance at 560 nm (1 cm cell). 
(3) Absorbance ratio of colour bound by phosphoryl cellulose is defined as the absorbance of the colour 
bound by phosphoryl cellulose at 280 nm divided by the absorbance at 560 nm 1 cm cell). 
30.10.85 Official Journal of the European Communities No C 278/13 
4-methylimidazole : 
not more than 250 mg/kg (*).• 
Total nitrogen: 
0,3 to 1,7 % (*). 
Total sulphur: 
0,8 to 2,5 % (»). 
Nitrogen/sulphur ratio of alcohol precipitate: 
0,7 to 2,7. 
Absorbance ratio of alcohol precipitate (2): 
8 to 14. 
Absorbance ratio (A 280/560): 
not more than 50. 
E 151 Brilliant black PN 
Brilliant black PN shall comply with the monograph for Brilliant black PN contained in FAO Food and 
Nutrition Paper No 31/1, p. 27, with the following exceptions: 
Assay (content): 
not less than 70 % total colouring matters. 
Loss on drying at 135 °C: 
not more than 30 %. 
Chloride and sulphate (calculated as sodium salts): 
not more than 30 %. 
E 153 Vegetable carbon 
Vegetable carbon shall comply with the monograph for Carbon blacks contained in FAO Food and 
Nutrition Paper No 31/1, p. 43. 
E 154 Brown FK 
Chemical description: 
Brown FK consists essentially of a mixture of: 
(i) sodium 4-(2,4-diaminophenylazo)benzenesulphonate 
(ii) sodium 4-(4,6-diamino-m-tolylazo)benzenesulphonate 
(iii) disodium 4,4'-(4,6-diamino-1,3-phenylenebisazo)di(benzenesulphonate) 
(iv) disodium 4,4'-(2,4-diamino-l,3-phenylenebisazo)di(benzenesulphonate) 
(v) disodium 4,4'-(2,4-diamino-5-methyl-l,3-phenylenebisazo)di(benzenesulphonate) 
(vi) trisodium 4,4',4"-(2,4-diaminobenzene-l,3,5-trisazo)tri(benzenesulphonate) 
and subsidiary colouring matters, together with sodium chloride and/or sodium sulphate as the principal 
uncoloured components. 
Assay (content): 
not less than 70 % of a mixture of (i), (ii), (iii), (iv), (v) and (vi), and subsidiary colouring matters. 
Furthermore, the proportions of the various components of the colours shall not exceed: 
(*) Expressed on equivalent colour basis. 
(') 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). 
No C 278/14 Official Journal of the European Communities 30. 10. 85 
(i) 26% 
(ii) 17% 
(iii) 26% 
(iv) 16% 
(v) 20 % 
(vi) 16% (TLC) 
not more than 0,0070 %. 
not more than 0,7 % (HPLC). 
not more than 0,35 % (HPLC). Subsidiary dyes: 
not more than 3,5 % (TLC). 
Organic compounds other than colouring matters: 
Unsulphonated primary aromatic amines other than 
m-phenylene diamine and 4-methyl-m-phenylene diamine 
Sulphanilic acid 
m-phenylene diamine and 4-methyl-m-phenylene diamine 
Water insoluble matter: 
not more than 0,2 %. 
Matter extractable by diethyl ether: 
not more than 0,2 % from an aqueous solution. 
Loss on drying at 135 °C: 
not more than 30 %. 
Chloride and sulphate (calculated as sodium salts): 
not more than 30 %. 
E 155 Brown HT 
Brown HT shall comply with the monograph for Brown HT contained in FAO Food and Nutrition Paper 
No 31/1, p. 35. 
E 160 a (i) Mixed carotenes 
Definition: 
Mixed carotenes are obtained by hexane extraction of edible vegetables with subsequent removal of the 
solvent. The main colouring principle is beta-carotene, but alpha- and gamma-carotene may be present. 
Mixed carotenes also contain other pigments and other substances such as oils, fats and waxes derived 
from the source material. It is necessary to add an edible oil (e.g. peanut oil, corn oil, palm oil) 
immediately after the extraction to stabilize the product. Because the maximum solubility of carotenes in 
oil is about 1 %, concentrated carotenes are oil suspensions and not solutions. Carotenes are insoluble in 
water and soluble in hexane, oils and fats. 
Content: 
Oil suspensions: not less than 5 % expressed as beta-carotene. 
Oil solutions: not less than 0,2 % expressed as beta-carotene. 
Spectral characteristics: 
Maximum absorption at 450 nm in hexane and at 455 nm in cyclohexane. 
Solvent Residue: 
T . , - 1 not more than 25 mg/kg, singly or in combination. 
E 160 a (ii) Beta-carotene 
Beta-carotene shall comply with the monograph for Beta-carotene-synthetic contained in FAO Food and 
Nutrition Paper No 31/1, p. 47. 
The substance shall also comply with the following: 
Volatile matter: 
not more than 0,1 % (60 °C; in vacuum). 
Phosphorus (as P): 
not more than 20 mg/kg. 
30.10. 85 Official Journal of the European Communities No C 278/15 
E 160 (b) Annatto extracts 
(i) Solvent extracted bixin and norbixin 
Chemical description: 
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 organic solvents: acetone, hexane, or methanol followed by the removal 
of the solvent. 
Norbixin is prepared by hydrolysis by aqueous alkali of the extracted bixin. 
Norbixin and bixin may contain other materials extracted from the annatto seed. 
Content: 
Bixin/Norbixin powders contain not less than 95 % total carotenoids calculated as bixin/norbixin. 
The bixin powder contains several coloured components, the major single one being bixin, which may be 
present in both cis- and trans-forms. Thermal degradation products of bixin may also be present. 
The norbixin powder contains the hydrolysis product of bixin, in the form of the sodium or potassium salts 
as the major colouring principle. Both cis- and trans-forms may be present. 
Colour intensity: 
1 % E Crt„ = 2 870 in chloroform, 1 cm-layer for pure bixin. 502 nm 
1 % . E .„_ =2 870 in 0,1 N sodium hydroxide, 1 cm-layer for pure norbixin. 482 nm / J 
Residual solvents: 
not more than 50 mg/kg singly or in combination. 
(ii) Alkali extracted annatto 
Chemical description: 
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.). 
Content: 
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. Water soluble 
annatto contains not less than 0,1 % of total carotenoids expressed as norbixin. 
Colour intensity: 
1 % E .„„ =2 870 in 0,1 N sodium hydroxide, 1 cm-layer for pure norbixin. 482 nm J 
(iii) Oil extracted annatto 
Chemical description: 
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 food-grade vegetable oil. 
Content: 
Annatto extract in oil contains several coloured components, the major single one being bixin, which may 
be present in both cis- and trans-forms. Thermal degradation products of bixin may also be present. 
Annatto extract in oil contains not less than 0,1 % of total carotenoids expressed as bixin. 
Colour intensity: 
1 % E c_„ = 2 870 in chloroform, 1 cm-layer for pure bixin. 502 nm J r 
E 160 c Paprika extract 
Paprika extract shall comply with the monograph for Paprika oleoresin contained in FAO Food and 
Nutrition Paper No 31/1, p. 105, with the following exceptions: 
Definition (chemical description): 
Paprika extract is obtained by solvent extraction of paprika, which consists of the ground fruits pods, with 
or without the seeds, of Capsicum annuum L., and contains the major colouring principles of this spice. The 
major colouring principles of paprika extracts are capsanthin and capsorubin. A wide variety of other 
coloured compounds is known to be present. The main flavouring component is capsaicin. 
No C 278/16 Official Journal of the European Communities 30.10. 85 
Only the following solvents may be used in the extraction: 
acetone, 
dichloromethane, 
ethanol, 
light petroleum, 
trichloroethylene. 
Residual solvents: 
Dichloromethane "\ not more than 30 mg/kg singly or in 
Trichloroethylene J combination. 
Other permitted extraction solvents (acetone, "\ not more than 50 mg/kg singly or in 
ethyl alcohol, light petroleum) J combination. 
The substance shall also comply with the following: 
Assay (content): 
Total carotenoids: 
not less than 9,5 %. 
Capsanthin and Capsorubin: 
not less than 75 % of total carotenoids. 
Capsaicin: 
not more than 0,5 %. 
Loss on drying at 135 °C: 
not more than 0,02 %. 
Unsaponifiable matter: 
not more than 14 %. 
Total fatty acids: 
not less than 75 %. 
E 160 e Beta-apo-8'-carotenal (C 30) 
Beta-apo-8'-carotenal shall comply with the monograph for Beta-apo-8'-carotenal in FAO Food and 
Nutrition Paper No 31/1, p. 13. 
The substance shall also comply with the following: 
Volatile matter: 
not more than 0,1 % (60 °C vacuum). 
Phosphorus (as P): 
not more than 20 mg/kg. 
E 160 f Ethyl ester of Beta-apo-8'-carotenoic acid (C 30) 
Ethyl ester of Beta-apo-8'-carotenoic acid (C 30) shall comply with the monograph for Beta-apo-8'-
carotenoic acid ethyl ester in FAO Food and Nutrition Paper No 31/1, p. 17. 
The substance shall also comply with the following: 
Volatile matter: 
not more than 0,1 % (60 °C vacuum). 
Phosphorus (as P): 
not more than 20 mg/kg. 
E 161 Xanthophylls 
Chemical description: 
Xanthophylls are prepared by physical means and are defined as the 3-hydroxy- and 3,3'-dihydroxy-deri-
vatives of alpha-, beta-, and gamma-carotenes, their naturally occurring mono- and di-epoxides, 
neoxanthin, neochrome and the fatty acid esters of these compounds present in natural food. 
Xanthophylls are obtained by hexane extraction of the food and subsequent removal of the solvent. After 
removal of the solvent, the product may be mixed with edible vegetable oils. Xanthophylls may contain 
other substances, such as oils, fats and waxes derived from the source material. 
30.10. 85 Official Journal of the European Communities No C 278/17 
Content: 
not less than 1 % total colouring matters. 
Residual solvents: 
not more than 50 mg/kg, singly or in combination. 
E 161 g Canthaxanthin 
Canthaxanthin shall comply with the monograph for Canthaxanthin in FAO Food and Nutrition Paper No 
31/1, p. 39. 
The substance shall also comply with the following: 
Volatile matter: 
not more than 0,1 % (60 °C vacuum) 
Phosphorus (as P): 
not more than 20 mg/kg 
E 162 Beetroot red 
Beetroot red shall comply with the monograph for Beetroot red in FAO Food and Nutrition Paper No 
31/1, p. 23, with the following exceptions: 
Content (assay) (calculated as betanin): 
not less than 1,2 % betanin (in liquid or powder forms). 
Beetroot red shall also comply with the following: 
Nitrate (as sodium nitrate): 
not more than 25 mg/kg product (in liquid or solid forms). 
E 163 Anthocyanins 
Anthocyanins shall comply with the monograph for Grape skin extract in FAO Food and Nutrition Paper 
No 31/1, p. 87, with the following exceptions: 
Definition: 
Anthocyanins are obtained by extraction with water, methanol or ethanol from vegetables or edible fruits. 
Anthocyanins contain the common components of the source material, namely anthocyanine, tartaric acid, 
tannins, sugars, minerals, etc., but not necessarily in the same proportion as found in the source material. 
During the extraction process, food-grade acid or aqueous solution of sulphite may be added as pH regu­
lating agent and stabilizer. During the process, most of the extracted sugars are fermented to alcohol. The 
extract may be concentrated by vacuum evaporation during which the alcohol is removed. 
Sulphur dioxide: 
not more than 1 000 mg/kg (liquid extracts; 10 baume), 
not more than 5 000 mg/kg (dried extracts). 
The material shall also comply with the following: 
Residual solvents (methanol, ethanol): 
not more than 50 mg/kg singly or in combination. 
E 170 Calcium carbonate 
Description: 
White crystalline or amorphous powder 
Content: 
not less than 97 % of CaC03 on a volatile matter free basis Hexane \ 
Light petroleum ) 
No C 278/18 Official Journal of the European Communities 30.10.85 
Volatile matter: 
not more than 1 % (determine by drying to constant weight at 105 °C) 
not more than 100 mg/kg singly or in combination. Antimony (as Sb) 
Copper (as Cu) 
Chromium (as Cr) 
Zinc (as Zn) 
Barium (as Ba) 
E 171 Titanium dioxide 
Titanium dioxide shall comply with the monograph for Titanium dioxide in FAO Food and Nutrition 
Paper No 31/1, p. 135. 
E 172 Iron oxides and hydroxides 
Iron oxides and hydroxides shall comply with the monograph for Iron oxides in FAO Food and Nutrition 
Paper No 31/1, p. 99. 
The materials shall also comply with the following: 
Loss on ignition: 
not more than 15 %. 
E 173 Aluminium 
Aluminium shall comply with the monograph for Aluminium powder in FAO Food and Nutrition Paper 
No 31/1, p. 7, with the following exception: 
Lead: 
not more than 10 mg/kg. 
E 174 Silver 
Content: 
not less than 99,5 % calculated as Ag. 
E175 Gold 
Content: 
not less than 99,5 % calculated as Au. 
E180 Lithol rubine BK 
Lithol rubine BK shall comply with the monograph for Lithol rubine BK in FAO Food and Nutrition 
Paper No 31/1, p. 101.'