Amended proposed regulation on genetically modified food and feed

Brussels, 10 Oct 2002

Amended proposal for a
Regulation of the European Parliament and of the Council on Genetically Modified Food and Feed
(presented by the Commission pursuant to Article 250 (2) of the EC-Treaty) Full Text

EXPLANATORY MEMORANDUM

1. BACKGROUND

­ Adoption of the proposal by the Commission on 25 July 2001 and transmission to the Parliament and the Council on 30 July 2001 ( COM(2001) 425 final ­ 2001/0173(COD)), on the basis of Articles 37, 95 and 152 (4) (b) of the EC-Treaty.

­ Opinion of the Committee of the Regions adopted on 16 May 2002.

­ Opinion of the Economic and Social Committee adopted on 30 May 2002.

­ Opinion of the European Parliament at first reading adopted on 3 July 2002.

2. OBJECTIVE OF THE COMMISSION PROPOSAL

The objective of the proposal is to provide the basis for ensuring a high level of protection of human life and health, animal health, environment and consumers' interest in relation to genetically modified food and feed, whilst ensuring the effective functioning of the internal market.

The proposal lays down centralised Community procedures for the assessment, authorisation and supervision of genetically modified food and feed, as well as labelling requirements for these products.

3. COMMISSION POSITION ON THE 111 AMENDMENTS ADOPTED BY THE PARLIAMENT

3.1. Amendments accepted by the Commission

The Commission can accept amendments 13, 16, 17, 18, 19, 31, 70, 78, 110, 115, 119, 123, 124, 145, 146 and 147, as these amendments improve or bring clarification to the Commission's initial proposal.

Amendment 13 makes explicit reference in Article 1 of the proposal to the precautionary principle, which is taken into account by the regime provided for by the proposal.

Amendment 16 aims at splitting the definition of "genetically modified food" from "genetically modified feed", which is consistent with the structure of the text of the proposal.

Amendments 17 and 18 refer to the definition of "genetically modified organisms for food and feed use" and suppress the reference to the exemption of genetically modified organisms not covered by the scope of Directive 2001/18/EC . This is accepted by the Commission because such exemption should rather be included in the definition of "genetically modified organism" (see also amendment 9 on the "Traceability and Labelling" proposal). For the sake of legal consistency, the exclusion provided for in Article 3 (1) of Directive 2001/18/EC , which refers to specific techniques of genetic modification, has to be taken into account in the present proposal.

Amendment 19 clarifies the wording of the definition of "control sample" in order to make a clear distinction between positive and negative control samples.

Amendments 31 and 78 require that the summary of the dossier submitted by the applicant be presented in a standardised form, which will make the handling and the access to the application easier. This is also in line with Directive 2001/18/EC .

Amendment 70 clarifies how the labelling of genetically modified food without pre- packaging has to be made in order to offer a better information to the consumer. It also adds reference to small pre-packagings, as the particularity of these items should be taken into account.

Amendments 110, 145, 146 and 147 suppress the mention of "but not containing a genetically modified organism" within the labelling requirements of food and feed produced from genetically modified organisms. This brings clarification to the labelling and suppresses unnecessary and possibly misleading information on the label.

Amendment 115 makes legally clear in Article 29 of the proposal that the Authority has the obligation - and not only the possibility - to examine whether the application for authorisation should be submitted both as food and feed.

Amendment 119 aims at deleting the proposed amendment to Article 12 (1) of Regulation (EC) No 258/97 , in order to maintain the possible application of the emergency clause of this Regulation to non-genetically modified novel foods in case of danger to the environment. It cannot be excluded indeed that new production processes could have effects on the environment.

Amendment 123 imposes a time limit of twelve months from the date of application of the proposed Regulation to the transitional measure laid down in Article 45 (2) of the proposal, so that the labelling requirements would fully apply to all genetically modified food and feed after this time limit.

Amendment 124 provides for the publication of the report on the implementation of the proposed Regulation and of any accompanying proposal. It is appropriate to refer explicitly to the public availability of these documents in Article 46 (1) of the proposal.

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Brussels, 08.10.2002 COM(2002) 559