Traceability and Labelling of Genetically Modified Organisms (GMOs) (Extract from Report on the Environment Council)

Brussels, 10 Dec 2002

Public deliberation

The Council reached a political agreement on a proposal for a Regulation of the European Parliament and of the Council concerning the traceability and labelling of GMOs and of food and feed products produced from GMOs. The Luxembourg, the Netherlands, the United Kingdom and the Danish delegations were unable to join this agreement. In accordance with the co-decision procedure, once the Council's common position is formally adopted at a forthcoming session, it will be sent to the European Parliament for a second reading.

This Regulation amends certain aspects of Directive 2001/18/EC on the deliberate release into the environment of GMOs. It aims to establish a framework for the traceability of products consisting of or containing GMOs, and food and feed derived from GMOs, with the objective of facilitating accurate labelling, monitoring of the effects on the environment and, where appropriate, on human health. The Regulation is aimed also at facilitating the implementation of appropriate risk management measures including, if necessary, withdrawal of products from the market.

The Council's political agreement provides for :

- traceability of GMO mixtures as or in products to be used directly as food or feed, as well as for processing:

operators may replace written information with a declaration of use accompanied by a list of the unique identifiers for all those GMOs that have been used to constitute the mixture;

- a special review clause:

no later than two years from the date of entry into force of the proposed regulation, the Commission shall forward to the European Parliament and to the Council a report on its implementation, in particular with regard to the traceability of mixtures, and where appropriate, make a proposal;

- exemptions from traceability and labelling:

the provisions of the proposed regulation do not apply to adventitious or technically unavoidable traces of authorised GMOs in products intended for processing for non-food/feed purposes, in a proportion no higher than 0.9%.

The proposed traceability system contains the following general elements:

- the establishment by the Commission of a system to identify GMOs via the assignment of a ifunique identifierln (e.g. numeric or alphanumeric code); this ihunique identifierlc will allow the retrieval of information concerning traits, characteristics and transformation processes of individual GMOs;

- systems and procedures to identify the operators to whom and from whom products are made available;

- the transmission by operators of information concerning the identity of a specific product;

- the retention of information by operators for a period of five years;

- a co-ordinated approach to inspections and controls.

Following the political agreement reached at the Agriculture and Fisheries Council on 28 November 2002 concerning a proposal for a regulation of the European Parliament and of the Council on genetically modified food and feed, the following thresholds will also apply in the context of this regulation:

- a 0,5 % threshold limit for adventitious traces of GMOs that are unauthorised but have nevertheless been assessed as being risk-free;

- a 0,9 % minimum threshold regarding the scope of application for labelling rules below which products can be exempted from labelling requirements.

The text agreed on at the Environment Council covers the overall chain of production and the commercial transactions that take place among different operators as regards traceability and labelling of GMOs. The compromise found recently at the Agriculture and Fisheries Council on a parallel proposal for a regulation on genetically modified food and feed concerns primarily products that are to be delivered as such to the final consumer.