PURPOSE : to provide a framework for the traceability of products consisting of or containing genetically modified organisms (GMOs), and food and feed produced from GMOs, with the objectives of facilitating accurate labelling, monitoring the effects on the environment and, where appropriate, on health, and the implementation of the appropriate risk management measures including, if necessary, withdrawal of products.
LEGISLATIVE ACT : Regulation 1830/2003/EC of the European Parliament and of the Council concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC.
CONTENT : the Council formally adopted two European Commission proposals on genetically modified organisms (GMOs) which establish a clear EU system to trace and label GMOs and to regulate the placing on the market and labelling of food and feed products derived from GMOs (refer to COD/2001/0173).
It should be noted that Luxembourg, the United Kingdom and the Danish delegations voted against this Regulation.
This new legislation will consolidate a trustworthy and safe approach to GMOs, GM food and GM feed. It will ensure full traceability of GMOs throughout the chain from farm to table and will provide consumers with comprehensive information by labelling all food and feed consisting of, containing or produced from a GMO.
The new Regulation calls for a Commission report to be submitted to the Council and the Parliament on the outcome of the Regulation's implementation in the Member States, for the standardisation of procedures that allow the holding of information on GMOs, for the publication of the Commission's technical guidance on sampling and testing, as well as for the setting up of a Central Register at Community level containing all available information and reference material for at least those GMOs authorised in the Community.
- Traceability : the new Regulation on traceability and labelling will require business operators when using or handling GM products to transmit and retain information at each stage of the placing on the market. Information concerning the presence of GMOs in products must be transmitted throughout the commercial chain and must be retained for five years. The industry will therefore have to ensure that systems are in place to identify to whom and from whom GM products are made available. Transmission and storage of information will reduce the need for sampling and testing of products. To facilitate a co-ordinated approach for inspection and control by Member State, the Commission will develop technical guidance on sampling and testing methods prior to the application of this Regulation.
- Labelling : in addition to the current rules the labelling of all foods produced from GMOs irrespective of whether there is DNA or protein of GM origin in the final product is included.
- GM-food : the Regulation The new law will extend the current labelling requirements to also cover such food (soya or maize oil produced from GM-soya or GM-maize) and food ingredients produced from GMOs (biscuits with maize oil produced from GM-maize). and to allow consumers to exercise their freedom of choice. The label has to indicate "This product contains genetically modified organisms" or "... produced from genetically modified (name oforganism)".
- GM-feed : the Regulation also introduces for the first time comprehensive labelling requirements of GM-feed based on the same principle as for GM food. Currently there are no labelling requirements in place for feed produced from GMOs. The Regulation will require labelling of, for example, GM-soy meal and any compound feed that includes in its composition the GM-soya meal. It will also require labelling of corn gluten feed produced from GM maize.
- Threshold for labelling : under current legislation the presence of GM material in conventional food does not have to be labelled if it is below 1% and if it can be shown to be adventitious and technically unavoidable. The Parliament confirmed today a threshold of no higher than 0,9%. Equally, under present legislation, there is no tolerance threshold for the adventitious presence of GM material in food or feed which has not yet been authorised but which has received a favourable EU scientific risk assessment. The Parliament has endorsed today a 0,5% threshold for the adventitious or technically unavoidable presence of such GM material, provided that the operator can demonstrate that its presence was technically unavoidable. Above this threshold the product will not be allowed on the market. This provision will expire after 3 years.
- Authorisation procedure : this Regulation establishes a "one door one key" procedure for the scientific assessment and authorisation of GMOs and GM food and feed resulting in a centralised, clear and transparent EU procedure where an operator is able to file a single application. The Regulation provides that GMOs that could be used as food or feed must be authorised for both uses or not at all. The scientific risk assessment will be carried out by the European Food Safety Authority. Its opinion will be made available to the public and the public will have the possibility to make comments. Products authorised shall be entered into a public register of GM-food and feed.
- Co-existence : measures to ensure that the production of organic and conventional crops can co-exist with GM-crops were introduced into the draft Regulation on GM Food and Feed during the second reading of the Parliament. In this context, Member States will be allowed to take appropriate measure to avoid the unintended presence of GMOs in other products. The Commission will bring forward a Recommendation to Member States providing a framework to put this into practice.
The United Kingdom and the Netherlands delegations have made a public statement on the provisions of the Regulation.
ENTRY INTO FORCE : 07/11/2003.�