Statement of the Council's Reasons on the common position for a Regulation concerning the traceability and labelling of genetically modified organisms and of food and feed products produced from them

March 31, 2003

Brussels, 28 Mar 2003

Full text of Document 15798/1/02 Addendum 01 Revision 01



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


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