CELEX: 51985PC0474
Language: en
Date: 1985-09-19
Title: 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

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,                              Whereas decisions should now be taken on the har-
                                                                      monization of the conditions governing the colouring of
Having regard to the Treaty establishing the European                 foodstuffs in the case of Brown FK, Red 2G,
Economic Community, and in particular Article 100                     carrageenan (E 407) and gum arabic (E 414);
thereof,
                                                                      Whereas the authorization of colouring matters should
Having regard to the proposal from the Commission,                    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
Having regard        to   the    opinion   of  the   European
                                                                      protection of public health the criteria of purity for the
Parliament,
                                                                      colouring matters authorized at Communtiy level should
                                                                      be revised;
Having regard to the opinion of the Economic and
Social Committee,
                                                                      Whereas this revision incorporates a re-examination of
                                                                      the nomenclature used to identify colouring matters in
Whereas the Council Directive of 23 October 1962 on                   the Directive,
the approximation of the rules of the Member States
concerning the colouring matters authorized for use in
foodstuffs intended for human consumption ('), as last                HAS ADOPTED THIS DIRECTIVE:
amended by Directive 81/20/EEC (2), lays down in
Annex II lists of colouring matters and substances used
                                                                                                 Article 1
for diluting and dissolving colouring matters which may
be authorized at national level by the Member States;                 The Directive of 23 October 1962 is hereby amended as
                                                                      follows:
Whereas, having regard to the most recent scientific and
toxicological information on these substances, with the               1. The following substances are added to the list in
exception of Yellow 2G it is possible to authorize the use               Article 6:
of substances in the said Annex II within the
Community; whereas, also, this information makes it                       'ethyl acetate, diethyl ether, glycerol monoacetate,
possible to introduce into the Directive the colouring                   glycerol diacetate, isopropyl alcohol, propane-1,2,-
matter Allura Red AC;                                                    diol, acetic acid, sodium hydroxide, ammonium
                                                                          hydroxide and, exclusively for the colouring matters
                                                                          listed under number E 160 and E 161 in Annex I,
Whereas, in the light of present-day requirements
                                                                          carrageenan and gum arabic'.
regarding the safety in use of colouring matters, Yellow
2G should no longer be permitted for use in foodstuffs;
                                                                      2. Article 8 is replaced by the following:
Whereas the prohibition so required should be given                        Article 8
effect under conditions which ensure the protection of
public health while avoiding as far as possible disruption               Member States shall take all measures necessary to
of a technological and economic nature;                                  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
C) OJ No 115, 11. 11. 1962, p. 2645/62.                                  in Annex I, satisfy the general and specific criteria laid
O O J N o L 4 3 , 14.2. 1981, p. 11.                                     down in Annex III.'
 ---pagebreak--- 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                                                 Article 2
   following:
                                                                            The marketing of foods containing Yellow 2G shall be
   '— the methods of analysis needed to verify that the                     prohibited as from [date: 18 months after notification].
        general and specific criteria of purity laid down in
        Annex III are satisfied, where these are not
        already specified in the relevant purity criteria                                                Article 3
        referred to in Annex III, and the modifications,                    Member States shall bring into force the laws, regu-
        where necessary, to methods specified in the                        lations and administrative provisions necessary to comply
        purity criteria in question'.                                       with this Directive not later than 12 months after
4. Annex I is replaced in accordance with Annex 1                           notification and shall forthwith inform the Commission
   hereto.                                                                  thereof.
5. Annex II is deleted.
                                                                                                         Article 4
6. Annex III is replaced in accordance with Annex 2
   hereto.                                                                  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.
                                                                                        Colour index number (') and name,
                 EEC No                          Common name                                 or chemical description
              (1) Colouring matters for both mass and surface colouring
              E 100            Curcumin                                          75300 (Natural yellow 3)
              E 101             (i) Riboflavin
                               (ii) Riboflavin-5'-phosphate
              E 102            Tartrazine                                        19140 (Food yellow 4)
              E 104            Quinoline yellow                                  47005 (Food yellow 13)
              E 110            Sunset yellow FCF                                 15985 (Food yellow 3)
                               Orange yellow S
              E 120            Cochineal/Carminic acid/Carmines                  75470 (Natural red 4)
              E 122            Azorubine                                         14720 (Food red 3)
                               Carmoisine
              E 123            Amaranth                                          16185 (Food red 9)
              E 124            Ponceau 4R                                        16255 (Food red 7)
                               Cochineal red A
              E 127            Erythrosine                                       45430 (Food   red 14)
              E 129            Allura red AC                                     16035 (Food   red 17)
              E 131            Patent blue V                                     42051 (Food   blue 5)
              E 132            Indigotine                                        73015 (Food   blue 1)
                               Indigo carmine
              E 133            Brilliant blue FCF                                42090 (Food blue 2)
              E 140            Chlorophylls and chlorophyllins                   75810 (Natural green 3)
                                                                                 75815 (Natural green 5)
                                (i) chlorophylls
                               (ii) chlorophyllins
              E 141            Copper complexes of chlorophylls and              75815 (Natural green 5)
                               chlorophyllins
                                (i) copper complexes of chlorophylls
                               (ii) copper complexes of chlorophyllins
 ---pagebreak--- No C 278/6                                  Official Journal of the European Communities                                          30.10.85
               EEC No                           Common name                             Colour index number (') and name,
                                                                                             or chemical description
           E142               Green S                                           44090 (Food green 4)
           E150a              Plain (spirit) caramel                            Caramel (2) prepared by the controlled heat
                                                                                treatment of carbohydrates with or without
                                                                                the presence of alkali or acid
           E 150 b            Caustic sulphite caramel                          Caramel prepared by the controlled heat
                                                                                treatment or carbohydrates with sulphite-
                                                                                containing compounds
           E 150 c            Ammonia caramel                                   Caramel prepared by the controlled heat
                                                                                treatment of carbohydrates with ammonia
           E 150 d            Sulphite ammonia caramel                          Caramel prepared by the controlled heat
                                                                                treatment of carbohydrates with ammonium
                                                                                and sulphite-containing compounds
           E 151              Brilliant black PN, Black PN                      28440 (Food black 1)
           E 153             Vegetable carbon
           E 155              Brown H T                                         20285 (Food brown 3)
           E 160 a             (i) Mixed carotenes                              75130 (Food orange 5)
                              (ii) Beta-carotene                                40800 (Food orange 5)
           E 160 b           Annatto extracts                                   75120 (Natural orange 4)
           E160c              Paprika extract
           E 160 d            (deleted)
           E 160 e            Beta-apo-8'-carotenal (C 30)                      40820 (Food orange 6)
           E 160 f            Ethyl ester of Beta-apo-8'-carotenic acid         40825 (Food orange 7)
                              (C30)
           E 161              Xanthophylls                                      Prepared by physical means from natural
                                                                                foods
           E 161 b            (deleted)
           E 161 c            (deleted)
           E 161 d            (deleted)
           E 161 e            (deleted)
           E 161 f            (deleted)
           E 161 g            Canthaxanthin                                     40850 (Food orange 8)
           E 162              Beetroot red
           E 163             Anthocyanins                                       Prepared by physical means from           edible
                                                                                fruits and vegetables
           E 171             Titanium dioxide                                   77891 (Pigment white 6)
           E 172              Iron oxides and hydroxides                        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              Calcium carbonate                                 77220
           E 173             Aluminium                                          77000 (Pigment metal 1)
           E 174              Silver
           E 175              Gold
           (3) Colouring matters for certain uses only
           E 128              Red2G                                             18050 (Food red 10)
                              (not for use in foodstuffs subject to high
                             temperature during processing, nor in
                             products of high acidity)
           E 154             Brown FK
                              (for cured fish only)
           E 180             Lithol Rubine BK                                   15851:1
                             (for cheese rind only)                             (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).'
 ---pagebreak--- 3 0 . 1 0 . 85                              Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s           N o C 278/7
                                                                    ANNEX III
                                                                      'ANNEX 2
                                                           CRITERIA O F 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.
                                                                        r
                  425 nm                                    '
               Solvent residues:
               Methanol:     1
               Hexane:        >   not more than 50 mg/kg singly or in combination.
               Acetone:
 ---pagebreak--- N o C 278/8                                Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s           30.10.85
            E 101 (i) Riboflavin
            Riboflavin shall comply with the monograph for riboflavin contained in FAO Food and Nutrition Paper
            No 3 1 / 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 N o 3 1 / 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 3 1 / 1 , p. 133.
            E 104 Quinoline yellow
            Quinoline yellow shall comply with the monograph for Quinoline yellow contained in FAO Food and
            Nutrition Paper N o 3 1 / 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 N o 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 3 1 / 1 , p. 63.
            E 122 Azorubine
            Azorubine shall comply with the monograph for Azorubine contained in FAO Food and Nutrition Paper
            No 3 1 / 1 , p. 21.
            E 123 Amaranth
            Amaranth shall comply with the monograph for Amaranth contained in FAO Food and Nutrition Paper
            N o 3 1 / 1 , p. 9.
 ---pagebreak--- 3 0 . 1 0 . 85        '                       Official J o u r n a l of the E u r o p e a n Communities               N o 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 3 1 / 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 3 1 / 1 , p. 71.
               E 128 Red 2G
               Red 2G shall comply with the monograph for Red 2G in FAO Food and Nutrition Paper N o 31/1, p. 121.
               E l 29 A l l u r a r e d A C
               Allura red AC shall comply with the monograph for Allura red AC contained in FAO Food and Nutrition
               Paper N o 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 3 1 / 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 N o
                    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.
 ---pagebreak--- N o C 278/10                               Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s           30.10.85
                 1 %
             E «       at 409 nm = not less than 70 (in C H C h ) .
                 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                              Not more than 50 mg/kg singly or in combination.
             methyl ethyl ketone
             dichloromethane
            propan-2-ol
             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-
 ---pagebreak--- 30.10.85                                Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s        N o 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 N o
         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). T o 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.
 ---pagebreak--- 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) E l 5 0 d
             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).
 ---pagebreak--- 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 P N
         Brilliant black PN shall comply with the monograph for Brilliant black P N contained in FAO Food and
         Nutrition Paper No 3 1 / 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 3 1 / 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).
 ---pagebreak--- N o C 278/14                                Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                30. 10. 85
               (i)  26%
              (ii)  17%
             (iii)  26%
                                 (TLC)
             (iv)   16%
              (v)   20 %
             (vi)   16%
             Subsidiary dyes:
             not more than 3,5 % (TLC).
             Organic compounds other than colouring matters:
             Unsulphonated primary aromatic amines other than
                                                                                                  not more than 0,0070 %.
             m-phenylene diamine and 4-methyl-m-phenylene diamine
             Sulphanilic acid                                                                     not more than 0,7 % (HPLC).
             m-phenylene diamine and 4-methyl-m-phenylene diamine                                 not more than 0,35 % (HPLC).
              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 H T
             Brown H T shall comply with the monograph for Brown H T contained in FAO Food and Nutrition Paper
             No 3 1 / 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 3 1 / 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.
 ---pagebreak--- 3 0 . 1 0 . 85                                Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s           N o 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
                                                                                J      for pure norbixin.
                   482 nm
               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,
                                                         J               1 cm-layer for pure norbixin.
                   482 nm
               (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   J     for pure
                                                                           r   bixin.
                   502 nm
               E 160 c Paprika extract
               Paprika extract shall comply with the monograph for Paprika oleoresin contained in FAO Food and
               Nutrition Paper No 3 1 / 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.
 ---pagebreak--- N o C 278/16                               Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s       3 0 . 1 0 . 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 3 1 / 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.
 ---pagebreak--- 3 0 . 1 0 . 85                                  Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s        N o C 278/17
                Content:
               not less than 1 % total colouring matters.
               Residual solvents:
               Hexane                    \
               Light petroleum          )   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 N o
               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 3 1 / 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 p H 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 C a C 0 3 on a volatile matter free basis
 ---pagebreak--- 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)
           Antimony (as Sb)
           Copper (as Cu)
           Chromium (as Cr)           not more than 100 mg/kg singly or in combination.
           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 3 1 / 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.'