EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 94/36/EC
of 30 June 1994
on  colours for use in foodstuffs
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE  EUROPEAN UNION
,
Having regard to the Treaty establishing the European Community, and in particular Article 100a  thereof,
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 (2) thereof,
Having regard to the proposal from the Commission (2),
Having regard to the opinion of the Economic and Social Committee (3),
Acting in accordance with the procedure referred to in Article 189b of the Treaty (4),
Whereas differences between national laws relating to the conditions of use of colours in food  hinder the free movement of foodstuffs; whereas this may create conditions of unfair competition;
Whereas the prime consideration for any rules on these food additives and their conditions of use  should be the need to protect and inform the consumer;
Whereas a food additive may only be used when there is evidence that it is technologically  necessary and that its use is not harmful to health;
Whereas colours are used to restore original appearance of food whose colour has been affected by  processing, storage, packaging and distribution, whereby visual acceptability may have been  impaired;
Whereas colours are used to make food more visually appealing and help identify flavours normally  associated with particular foods and to give colour to food otherwise colourless;
Whereas it is necessary to include certain colours intended for health marking of meat under the  responsibility of the official veterinarian pursuant to the requirements of Directive 91/497/EEC  (5), in particular Chapter XI of Annex I thereto;
Whereas only those colours authorized by this Directive should be used for the decoration of eggs  or for the stamping of eggs as provided in Regulation (EEC) No 1274/91 (6);
Whereas colours are used to reinforce colours already present in food;
Whereas it is generally recognized that unprocessed foodstuffs and certain other basic foodstuffs  should be free from food additives;
Whereas, having reagard to the most recent scientific and toxicological information on additives,  some of these are to be permitted only for certain foodstuffs and under certain conditions of use;
Whereas it is necessary to lay down strict rules for the use of additives in food for infants and  young children;
Whereas the Scientific Committee for Food has been consulted for those substances not yet being the  subject of a Community provision;
Whereas it is desirable that when a decision is taken on whether a particular foodstuff belongs to  a certain category of foods, the consultation of the Standing Committee for Food procedure be  followed;
Whereas this Directive replaces partially 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 (7);
Whereas the modification of existing purity criteria on colouring matters and new specification for  those where no purity criteria exist, will be proposed in accordance with the procedure of Article  11 of Directive 89/107/EEC;
Whereas, in order to protect consumers, the Community should promote research into the possible  effects (including those of a cumulative and synergic nature) on human health of colours used in  foodstuffs, with special reference to those whose harmlessness is in doubt,
1. This Directive is a specific directive forming a part of the  comprehensive directive within the meaning of Article 3 of Directive 89/107/EEC.
2. For the purposes of this Directive, 'colours' are substances which add or restore colour in a  food, and include natural constituents of foodstuffs and natural sources which are normally not  consumed as foodstuffs as such and not normally used as characteristic ingredients of food.
Preparations obtained from foodstuffs and other natural source materials obtained by physical  and/or chemical extraction resulting in a selective extraction of the pigments relative to the  nutritive or aromatic constituents are colours within the meaning of this Directive.
3. However, the following substances shall not be considered colours for the purposes of this  Directive:
- foodstuffs, whether dried or in concentrated form and flavourings incorporated during the  manufacturing of compound foodstuffs, because of their aromatic, sapid or nutritive properties  together with a secondary colouring effect, such as paprika, turmeric and saffron,
- colours used for the colouring of the inedible external parts of foodstuffs, such as cheese  coatings and sausage casings.
1. Only the substances listed in Annex I may be used as colours in foodstuffs.
2. Colours may be used only in the foodstuffs listed in Annexes III, IV and V and under the  conditions specified therein; colours may be used in those same foodstuffs when they are intended  for particular uses in accordance with Directive 89/398/EEC (1).
3. Colours may not be used in the foodstuffs listed in Annex II except where specifically provided  for in Annex III, IV or V.
4. Colours permitted for certain uses only are listed in Annex IV.
5. Colours permitted in general in foodstuffs and the conditions of use therefor are listed in  Annex V.
6. The maximum levels indicated in the Annexes:
- relate to ready-to-eat foodstuffs prepared according to the instructions for use,
- refer to the quantities of colouring principle contained in the colouring preparation.
7. In the Annexes to this Directive 'quantum satis' means that no maximum level is specified.  However, colouring matters shall be used according to good manufacturing practice at a level not  higher than is necessary to achieve the intended purpose and provided that they do not mislead the  consumer.
8. For the purpose of health marking as provided in Directive 91/497/EEC and other marking required  on meat products, only E 155 Brown HT, E 133 Brilliant Blue FCF or E 129 Allura Red AC or an  appropriate mixture of E 133 Brilliant Blue FCF and E 129 Allura Red AC may be used.
9. Only those colours mentioned in Annex I may be used for the decorative colouring of eggshells or  for the stamping of eggshells as provided in Regulation (EEC) No 1274/91.
10. Only those colours listed in Annex I, except E 123, E 127, E 128, E 154, E 160b, E 161g, E 173  and E 180, may be sold directly to consumers.
11. Within the meaning of this Directive 'unprocessed' means not having undergone any treatment  resulting in a substantial change in the original state of the foodstuffs. However, they may have  been for example divided, parted, servered, boned, minced, skinned, pared, peeled, ground, cut,  cleaned, trimmed, deep-frozen, frozen, chilled, milled or husked, packed or unpacked.
Without prejudice to other Community provisions, the presence of a colour in a  foodstuff is permissible:
- in a compound foodstuff other than one mentioned in Annex II to the extent that the colour is  permitted in one of the ingredients of the compound foodstuff,
or
- if the foodstuff is destined to be used solely in the preparation of a compound foodstuff and  to such an extent that the compound foodstuff conforms to the provisions of this Directive.
It may be decided by the procedure laid down in Article 5, whether a particular  foodstuff belongs to a category of foods mentioned in the Annexes, and whether substances are  colours in the meaning of Article 1.
1. Where the procedure laid down in this Article is to be followed, the Commission  shall be assisted by the Standing Committee on Foodstuffs, set up pursuant to Decision 69/414/EEC  (1), hereinafter referred to as 'the Committee'.
2. The chairman shall refer the matter to the Committee either on his own initiative or at the  request of the representative of a Member State.
3. The representative of the Commission shall submit to the Committee a draft of the measures to be  taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman  may lay down according to the urgency of the matter. The opinion shall be delivered by the majority  laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required  to adopt on a proposal from the Commission. The votes of the representatives of the Member States  within the Committee shall be weighted in the manner set down in that Article. The chairman shall  not vote.
4. (a) The Commission shall adopt the measures envisaged if they are in accordance with the  Committee's opinion.
(b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no  opinion is delivered, the Commission shall without delay submit to the Council a proposal relating  to the measures to be taken. The Council shall act by a qualified majority.
If, on the expiry of three months from the date of referral to the Council, the Council has not  acted, the proposed measures shall be adopted by the Commission.
Member States shall, within three years of the adoption of this Directive, establish  systems to monitor the consumption and use of colours and report their findings to the Commission.
The Commission shall report to the European Parliament within five years of the adoption of the  Directive on changes which have taken place in the colours market, the levels of use and  consumption.
In accordance with the general criteria of point 4 of Annex II to Directive 89/107/EEC, within five  years from the adoption of this Directive, the Commission shall review the conditions of use  mentioned in this Directive, and propose modifications where necessary.
Articles 1 to 7, Article 8 (1), second indent and (2), and Articles 9 to 15 of the  Directive of 23 October 1962 on colouring matters in foodstuffs are hereby repealed.
References to the repealed provisions shall be construed as references to the corresponding  provisions of this Directive.
The Commission shall, to coincide with the date of entry into force of this Directive,  launch a campaign, in conjunction with the European Parliament, national ministries, the food and  retail industries and consumer bodies, to inform consumers about the evaluation and authorization  procedures for permitted colours, and the meaning of the 'E' number system.
1. Member States shall bring into force the laws, regulations and administrative  provisions necessary to comply with this Directive not later than 31 December 1995 in order to:
- allow, not later than 31 December 1995, trade in and use of products conforming to this  Directive,
- prohibit, not later than 30 June 1996, trade in and use of products not conforming to this  Directive; products put on the market or labelled before that date which do not comply with this  Directive may, however, be marketed until stocks are exhausted.
They shall at once inform the Commission thereof.
2. When Member States adopt the measures referred to in paragraph 1, they shall contain a reference  to this Directive or shall be accompanied by such reference on the occasion of their official  publication. The methods of making such reference shall be laid down by Member States.
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This Directive shall enter into force on the day of its publication in the Official  Journal of the European Communities.
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This Directive is addressed to the Member States.