Directive 2003/114/EC of the European Parliament and of the Council of 22 December 2003 amending Directive 95/2/EC on food additives other than colours and sweeteners

Directive 2003/114/EC of the European Parliament and of the Council
of 22 December 2003
amending Directive 95/2/EC on food additives other than colours and sweeteners
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION
,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee(1),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),
Whereas:
(1) Food additives may be approved for use in foodstuffs only if they comply with Annex II to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption(3).
(2) Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners(4) lays down a list of food additives that may be used in the Community and the conditions for their use.
(3) There have been technical developments in the field of food additives since the adoption of Directive 95/2/EC. That Directive should be adapted to take account of those developments.
(4) Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production(5) provides for the adoption of a list of additives necessary for the storage and use of flavourings, and the adoption of any special conditions for the use of such additives that may be necessary for the protection of public health and to ensure fair trade.
(5) It is desirable to incorporate into Directive 95/2/EC those measures on additives necessary for the storage and use of flavourings, in order to contribute to transparency and consistency of Community legislation, and to facilitate compliance with Community legislation on food additives by food manufacturers, especially by small and medium-sized enterprises. In addition, according to Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(6), flavourings fall within the definition of "food".
(6) While the use of additives which are necessary to ensure the safety and quality of flavourings and to facilitate their storage and use should be authorised, the levels of additives present in such flavourings should be the minimum required to achieve the intended purpose. In addition, consumers should be guaranteed correct, adequate and non-misleading information on the use of additives.
(7) The presence of an additive in a foodstuff, due to the use of a flavouring, is generally low and the additive does not have a technological function in the foodstuff. However, if under certain circumstances the additive does have a technological function in the compound foodstuff, it should be considered as an additive of the compound foodstuff and not as an additive of the flavouring, and the relevant rules relating to the additive in the particular foodstuff should apply, including the labelling rules laid down in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs(7).
(8) In accordance with Directive 88/388/EEC, food manufacturers should be informed about the concentrations of all additives in flavourings in order to enable them to comply with Community legislation. That Directive also requires quantitative labelling of each component subject to a quantitative limitation in a foodstuff. A quantitative limitation is expressed either numerically or by the "quantum satis" principle.
(9) In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of ensuring market unity and a high level of consumer protection to lay down rules on the use of additives in flavourings. This Directive does not go beyond what is necessary in order to achieve the objectives pursued in accordance with the third paragraph of Article 5 of the Treaty.
(10) In accordance with a request from a Member State and the opinion of the Scientific Committee on Food, established by Commission Decision 97/579/EC of 23 July 1997 setting up Scientific Committees in the field of consumer health and food safety(8), hydrogenated poly-1-decene, which was authorised at national level under Directive 89/107/EEC, should be authorised at Community level.
(11) Biphenyl (E 230), orthophenyl phenol (E 231) and sodium orthophenyl phenol (E 232) are listed as preservatives in and on citrus fruits in Directive 95/2/EC. However, they fall under the definition of "plant protection products" in Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(9). Therefore, they should no longer come within the scope of Directive 95/2/EC. The Member States and the Commission should take all possible steps to ensure that there is no legal vacuum with regard to these substances. Authorisation to place on the market these substances as plant protection products should be dealt with as swiftly as possible.
(12) On 4 April 2003, the Scientific Committee on Food stated that the temporary acceptable daily intake for E 214 to E 219 p-hydroxybenzoic acid alkyl esters and their sodium salts should be withdrawn if no further data are submitted in respect of intake and toxicity.
(13) Directive 95/2/EC should therefore be amended accordingly.
(14) Council Directive 67/427/EEC of 27 June 1967 on the use of certain preservatives for the surface treatment of citrus fruit and on the control measures to be used for the qualitative and quantitative analysis of preservatives in and on citrus fruit(10) lays down the control measures on preservatives in and on citrus fruits. Since those preservatives are no longer authorised for use in citrus fruits by Directive 95/2/EC, it is necessary to repeal Directive 67/427/EEC.
(15) The Scientific Committee on Food has been consulted on the adoption of provisions that may have an effect upon public health, pursuant to Article 6 of Directive 89/107/EEC,