Common position for a Regulation on the traceability and labelling of GMOs food and feed products produced from GMOs - Draft Statement of the Council's Reasons

March 12, 2003

Brussels, 11 Mar 2003

Full text of Document 15798/02


1. General

The main issues of the Regulation are requirements for traceability and labelling of products that consist of or contain GMOs (Article 4), and provisions for traceability of products that are produced from GMOs but do not contain GMOs themselves (Article 5). In this respect, as well as with regard to the scope of the Regulation, the Council fully accepts the Commission proposal.

Exemptions from the traceability and labelling scheme shall be allowed for the adventitious or technically unavoidable presence of traces of GMOs (Articles 4(7), 4(8) and 5(4)). The thresholds for these exemptions are introduced in this Regulation by way of reference to the respective Articles of the Regulation on genetically modified food and feed (as discussed in parallel with this Regulation), where the threshold level has been set at 0,9% and can be lowered via a regulatory committee procedure, as well as by way of reference to Directive 2001/18/EC . While the exemptions generally cover only GMOs that have been authorised in the EU, the adventitious or technically unavoidable presence of such GMOs that have not been authorised but have benefited from a favourable risk evaluation will be permitted below a threshold level of 0,5%, or lower as set by a regulatory committee procedure, for a transitional period of three years.

The Council has tightened the Commission proposal with regard to the information that has to accompany bulk shipments of products containing mixtures of GMOs (Article 4(3)) by allowing only for "...a list of the unique identifiers for all those GMOs that have been used to constitute the mixture", instead of "... unique codes for the GMOs that the product may contain" as originally proposed by the Commission.

Complementary to this provision, the Council has introduced a review clause (Article 12) in order to call on the Commission
- to present a report after the first experiences with the provision of Article 4(3) have been gained in practice and
- where appropriate, to make proposals for changes to the Regulation.

While the Regulation generally covers all stages of placing on the market of the products, the Council has filled a gap by introducing that inspection and control measures can also target the holding of a product.

The Commission has accepted the common position agreed by the Council.

2. European Parliament Amendments

In its plenary vote on 3 July 2002, the EP adopted 30 amendments to the proposal. While 15 of these amendments could not be accepted by the Council, another 15 have been incorporated either verbatim, in part or in spirit into the common position.

(a) The 15 amendments that have been incorporated can be grouped as follows:

5 amendments accepted verbatim:

Amendment 9 has been incorporated in the definition of "Genetically modified organism" in Article 3.

Amendment 10 has been incorporated in the definition of "Operator" in Article 3.

Amendment 11 has been taken on board in the definition of "Food" in Article 3.

Amendment 13: "to the ultimate user" has been deleted from the definition of "Pre-packaged" in Article 3.

Amendment 14: an improved provision for labelling as proposed in this amendment has been incorporated in Article 4(6).

10 amendments accepted in part or in spirit:

Amendment 2: the reference to the precautionary principle has been incorporated in Recital 3, and Article 1 now refers to appropriate risk management measures.

Amendment 6: several aspects of this long amendment have been taken up in Article 1 (reference to health) and Recital 3 (references to the precautionary principle, to the protection of human and animal health, and to the protection of ecosystems).

Other issues mentioned in the amendment are not regarded as appropriate for consideration in the Regulation.

Amendment 12 has been, in principle, incorporated in the definition of "Placing on the market" in Article 3 by way of referring to Article 2(4) of Directive 2001/18/EC . However, for reasons of consistency, the Council gives priority to definitions, in the event that they exist, in the specific Community legislation under which the relevant product has been authorised.

Amendment 24: the spirit of this amendment has been taken on board by clarifying the exemption in Article 6 through the addition of the sentence "This Article does not apply to the first stage of placing on the market of a product or to primary manufacture or re-packing of a product.", as contained in the amended Commission proposal.

Amendment : with regard to "good segregation practice", the Council has agreed upon a declaration in connection with the Regulation on genetically modified food and feed. The declaration was added to the minutes of the Agriculture/Fisheries Council of 28/29 November 2002 and reads as follows:


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