Commission Regulation (EC) No 1565/2000 of 18 July 2000 laying down the measures necessary for the adoption of an evaluation programme in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council (Text with EEA relevance)

• Published date: 19 July 2000
• Subject Matter: Foodstuffs,Consumer protection
• Official Gazette Publication: Official Journal of the European Communities, L 180, 19 July 2000

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32000R1565

Commission Regulation (EC) No 1565/2000 of 18 July 2000 laying down the measures necessary for the adoption of an evaluation programme in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council (Text with EEA relevance)

Official Journal L 180 , 19/07/2000 P. 0008 - 0016

Commission Regulation (EC) No 1565/2000

of 18 July 2000

laying down the measures necessary for the adoption of an evaluation programme in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 2232/96 of the European Parliament and of the Council of 28 October 1996 laying down a Community procedure for flavouring substances used or intended for use in or on foodstuffs(1) and in particular Article 4 thereof,

Whereas:

(1) Commission Decision 1999/217/EC(2) adopted a register of flavouring substances used in or on foodstuffs drawn up in application of Regulation (EC) No 2232/96.

(2) Regulation (EC) No 2232/96 lays down in its Annex the general criteria for the use of flavouring substances. It covers, in particular, that they present no risk to the health of the consumer and that their use does not mislead the consumer.

(3) In order to check that the flavouring substances contained in the register comply with the general use criteria, Article 4(1) of Regulation (EC) No 2232/96 provides that a programme for the evaluation of these flavouring substances is to be carried out. According to Article 4(3) substances have to be deleted from the register, where, following evaluation, it is clear that they do not comply with the general use criteria.

(4) As the first step of the evaluation programme the substances of the register should receive FL-numbers according to their chemical characteristics and should be distributed in groups of structurally related compounds which are expected to show some metabolic and biological behaviour in common.

(5) In the light of the large number of flavouring substances in the register and the deadline set by the Regulation by which a list of authorised flavouring substances shall be adopted, the evaluation programme should not waste scientific resources and, therefore, make use of safety assessments already performed by the Committee of Experts on Flavouring Substances of the Council of Europe (CEFS), the Scientific Committee on Food of the European Commission (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

(6) The Scientific Committee on Food has been consulted, addressing especially the question whether results of evaluations of other scientific committees can be accepted. In its conclusion expressed on 2 December 1999, the SCF was of the opinion that, subject to certain exceptions, flavourings considered acceptable at the current estimated intake by JECFA comply with the general use criteria and could be included in the list of authorised substances without undergoing a separate SCF evaluation for the time being. Likewise, the SCF concluded that flavourings previously evaluated by the SCF and CEFS as being safe, need not be re-evaluated as the criteria previously used are stringent enough to consider the substances to be safe in current use.

(7) The Scientific Committee on Food further considered that for the remaining flavouring substances, unnecessary duplication of work could be avoided by dividing different groups of substances between JECFA and the SCF for evaluation.

(8) Article 4(2) of Regulation (EC) No 2232/96 provides that the person responsible for placing the substances on the market shall forward the data necessary for the evaluation to the Commission. Information about the substances on purity, chemical specification, natural occurrence in food, total amount added to foods and results of toxicological and metabolic studies are considered to be essential for the evaluation. In order to enable a constant evaluation over the whole period the information should be presented as soon as possible and be available well in advance of the evaluation of a particular substance. The information should be updated as soon as new data are available.

(9) If the data provided on chemical identity of a substance and the amount added to foods or the toxicological and metabolic studies on a substance or on closely related substances appear to be insufficient, further data may be requested. Following the initial exposure assessment which should be based on the total amounts added to foods more refined usage data might become necessary for the evaluation of certain substances.

(10) In order to enable the completion of the evaluation programme within five years, deadlines for the submission of information have to be set as well as minimal numbers of substances to be evaluated within a given time period.

(11) Where the necessary information is not provided, so that the evaluation of a flavouring substance cannot be undertaken, that substance may not be included in the definitive list of flavouring substances referred to in Article 5 of Regulation (EC) No 2232/96.

(12) The register contains about 2800 substances. Following the opinion of the SCF, it can be concluded that about 800 substances need not be re-evaluated for the time being. Based on the assumption...