Commission Decision

of 23 January 2002

amending Commission Decision 1999/217/EC as regards the register of flavouring substances used in or on foodstuffs

(notified under document number C(2002) 88)

(Text with EEA relevance)

(2002/113/EC)

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 3(2) thereof,

Whereas:

(1) Pursuant to Article 3(2) of Regulation (EC) No 2232/96, the Commission through its Decision 1999/217/EC(2), as amended by Decision 2000/489/EC(3), adopted a register of flavouring substances used in or on foodstuffs.

(2) According to 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(4), new numbers, so called "FL numbers", should be attributed to each flavouring substance. In addition, all flavouring substances of the register should be subdivided into groups of related substances according to the list of groups as laid down in that Regulation. This information should be available to the persons placing the substance on the market so that they can fulfil their obligations according to Regulation (EC) No 1565/2000. The register of flavouring substances should therefore provide the new FL numbers and group numbers.

(3) Parts 1, 2, and 3 of the Register annexed to Decision 1999/217/EC, as amended by Decision 2000/489/EC, should be combined into one part, part A, and the substances should be listed according to their FL numbers. Part 4 of the Register should be replaced by the text in part B of the Register annexed to this Decision.

(4) Scrutiny of the flavouring substances notified by Member States and laid down in Decision 1999/217/EC revealed a number of inconsistencies in the chemical numbers, names, synonyms and systematic names and identified a number of cases where the same substances appeared under different chemical names in the register. These inconsistencies should be corrected. Where for those inconsistencies for which no final conclusion could be reached at this stage, at least the fact of a possible inconsistency should be mentioned.

(5) For a number of substances of Decision 1999/217/EC, including confidentially notified substances, certain Member States have withdrawn their respective notifications. These substances should be deleted from the register. Likewise, Member States have notified new substances which in accordance with Article 5(2) of Regulation (EC) No 2232/96 should be included in the evaluation programme and need therefore to be incorporated into the register.

(6) According to Article 4(3) of Regulation (EC) No 2232/96, a substance shall be deleted from the register if it is apparent, following the evaluation, that a flavouring substance does not comply with the general use criteria given in the Annex of the said Regulation. The Scientific Committee on Food concluded in its opinions expressed on 26 September 2001 that 4-Allyl-1,2-dimethoxybenzene (methyleugenol) and 1-Allyl-4-methoxybenzene (estragole) are genotoxic. These substances should therefore be deleted from the register.

(7) Decision 1999/217/EC should therefore be amended accordingly.

(8) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee for Foodstuffs,

HAS ADOPTED THIS DECISION:

Article 1

The Register annexed to Decision 1999/217/EC is replaced by the text in the Annex to this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 23 January 2002

For the Commission

David Byrne

Member of the Commission

(1) OJ L 299, 23.11.1996, p. 1.

(2) OJ L 84, 27.3.1999, p. 1.

(3) OJ L 197, 3.8.2000, p. 53.

(4) OJ L 180, 19.7.2000, p. 8.

ANNEX

"Register of flavouring substances notified by the Member States pursuant to Article 3(1) of Regulation (EC) No 2232/96 of the European Parliament and the Council of 28 October 1996 laying down a Community procedure for flavouring substances used or intended for use in or on foodstuffs

The register of chemically defined flavouring substances has been divided into two distinct parts. Part A lists the substances according to their FL numbers. Part B lists those substances for which confidentiality has been requested by a Member State in order to protect the intellectual property rights of the manufacturer.

In part A, CAS(1), Einecs(2), CoE(3) and FEMA(4) numbers are indicated, where available.

A number in the column "comments" refers to one of the following remarks:

1. Substance which, apart from its flavouring properties, is used for other purposes on or in foodstuffs, and, therefore, may be subject to additional legal provisions.

2. Substance the use of which is subject to restrictive or prohibitive measures in certain Member States.

3. Substance to be given priority in the evaluation programme laid down in Regulation (EC) No 1565/2000.

4. Substance on which additional information is to be submitted.

5. Name, synonyms, systematic names, CAS, Einecs, CoE or FEMA number might contain inconsistencies.

A specific question raised concerned the treatment of salts and other derived compounds from a "generic" substance. Certain substances had been notified with a high degree of precision. Other substances are lacking this detailed identification. On a number of acids or bases, no specific guidance is given on the actual covering of their derived salts. It is provisionally presumed, but only for the purpose of this register, that ammonium, sodium, potassium and calcium salts, as well as chlorides, carbonates and sulphates, are covered by the "generic" substance, providing they have flavouring properties. However, final acceptance will depend of the results of the evaluation, which in these cases should verify carefully the accuracy of such assimilation.

PART A

FLAVOURING SUBSTANCES

(ordered by FL numbers)

>TABLE>

PART B

FLAVOURING SUBSTANCES NOTIFIED IN APPLICATION OF ARTICLE 3(2) OF REGULATION (EC) Nο 2232/96, FOR WHICH THE PROTECTION OF THE INTELLECTUAL PROPERTY RIGHTS OF THE MANUFACTURER HAS BEEN REQUESTED

>TABLE>

(1) Chemical Abstracts Service.

(2) European Inventory of Existing Chemical Substances.

(3) Council of Europe.

(4) Flavour and Extract Manufacturers' Association of the US."