Brussels, 22 July 2003
European legislative framework for GMOs is now in place
The Council of Ministers today 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. 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.
Environment Commissioner Margot Wallström said: "I welcome today's final adoption by Council of the new legislation on labelling and traceability of GMOs, which completes the EU's legislation on GMOs. It will reinforce our international credibility and will certainly help in building public confidence in new technologies.. By ensuring that GMOs can be traced at all stages in the production and marketing chain, we provide a robust safeguard system and the foundation for a comprehensive labelling system. In this way, we address the most critical concerns of the public regarding the environmental and health effects of GMOs and enable consumers to chose."
Health and Consumer Protection Commissioner David Byrne said: “I am very pleased that the European legislative framework for GMOs is now complete. European consumers can now have confidence that any GM food or feed marketed in Europe has been subject to the most rigorous pre-marketing assessment in the world.: Consumers will also have a clear choice of products to buy as GM food will now be clearly labelled. For the first time farmers will see labels on GM-feed. Europe will now have a comprehensive and transparent system of authorisation and labelling that can only enhance business and consumer confidence.”
Traceability provides the means to track the movement of GM products through the production and distribution chains. Traceability for certain products has existed for many years. However, specific traceability requirements for products that contain GMOs or are derived from GMOs do not currently exist.
Traceability will also facilitate monitoring of any effects on the environment, accurate labelling and the control of labelling claims. It additionally would enable products to be withdrawn from the market if any unexpected adverse effects were to arise. 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.
The draft law will add to the current rules the labelling of:
Already today, retailers have to label food consisting of or containing GMOs. This also includes food produced from GMOs if traces of DNA or protein from the genetic modification is detectable in the final product (such as flour produced from genetically modified maize.
However, these labelling provisions do not cover some foods or food ingredients, such as highly refined soya or maize oil produced from GM-soya or GM-maize. 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 of organism)”.
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
Minute traces of GMOs in conventional food and feed could arise during cultivation, harvest, transport and processing. Whether we like it or not this has become a reality. This is something that is not particular to GMOs. In the production of food, feed and seed, it is practically impossible to achieve products that are 100% pure.
With this background, the EU's objective is to ensure legal certainty and establish certain thresholds above which conventional food and feed have to be labelled as consisting of or containing or being produced from a GMO.
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%.
GMOs scientifically assessed in the EU to be safe
Under current 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.
Clear rules are set out in the EU for the assessment and authorisation of GMOs and GM-food but responsibilities are shared between Member States and the Community. The 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. On the basis of this opinion, the Commission will draft a proposal for granting or refusing authorisation. The proposal will as it is currently the case be approved through qualified majority by the Member States within a Regulatory Committee. Products authorised shall be entered into a public register of GM-food and feed. The authorisation should be granted for a period of 10 years, subject where appropriate to a post-market monitoring plan. Authorisations are renewable for 10-year periods.
The simplified procedure for putting on the market GM-foods which are considered to be substantially equivalent to existing foods will be abandoned.
Current GM-products will remain eligible for marketing. Operators will however be obliged to provide detection methods to the Commission within six months of entry into force of the new law. The Regulation also establishes the Joint Research Centre (JRC) of the Commission as new Community Reference Laboratory which will have the main task of validating detection methods. The JRC will continue to work with the “European Network of GMO laboratories”.
Existing GM-products shall also be entered into the public register and the time limit of 10 years from the day when the concerned product was first placed on the market equally applies to them.
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 legislation will enter into force 20 days after publication in the Official Journal of the European Union. Operators have to comply with the new previsions on labelling within 6 months after the date of publication.