FOREIGN AGRICULTURAL SERVICE
EU Policy |
Labeling & Traceability |
Authorization procedure | Co-existence
Since May 2004, only 9 biotech products have been authorized for marketing in the EU. "Authorized for marketing" means that the product is reviewed and approved for sale for a specific use or uses. For all 9 products, the European Commission recommended that the Member States authorize the marketing of these products based on the positive risk assessment issued by the European Food Safety Authority (EFSA). Despite EFSA's positive assessments, the Member States failed to reach a qualified majority for or against approval. The Commission then asked the Council of Ministers to come to a decision but after three months the Council also deferred and sent the matter back to the Commission. The Commission then authorized the marketing of the biotech products. Click here for more information on the EU decision-making procedure.
The breakdown in the EU's approval process for biotech products has blocked most U.S. exports of corn and hinders trade in other products. Over 47 applications, as of 10/03/07, are in the pipeline still waiting approval. Biotechnology continues to be more of a political than a scientific issue in Europe and the prospects for improvement remain dim. Several products have been under review for more than six years, as compared to an average six to nine-month process in Canada, Japan and the United States. Many food processors and exporters have either reformulated or sought out non-biotech sources in response to the implementation of mandatory traceability and labeling requirements put in place in April 2004.
Austria, Denmark, France, Germany, Greece and Luxembourg have imposed marketing bans on some biotechnology products despite existing EU approvals and positive risk assessments from the EU’s scientific committee. In June 2005, the Commission’s proposal to overturn these bans was voted down by the Environment Council. On May 13, 2003, the U.S., Argentina and Canada initiated WTO consultations with the EU regarding this de facto moratorium on biotech product approvals.
Statement on EU-Biotech Dispute (U.S. Trade Representative - Feb. 4, 2008)
Labeling and Traceability of Genetically Modified Food and Feed
On April 18, 2004, the EU implemented the regulations on “Genetically Modified Food and Feed” (European Parliament and Council Regulation 1829/2003) and “Traceability and Labeling of Genetically Modified Organisms and the Traceability of Food and Feed Products produced from Genetically Modified Organisms” (European Parliament and Council Regulation 1830/2003). These regulations introduce an EU system to trace GMOs, set out labeling rules for GM food and feed, and establish an authorization procedure for GMOs in food and feed and their deliberate release into the environment. Both regulations have two-year review clauses, which require the Commission to report on their implementation and make recommendations for changes, if appropriate. Recommended changes must be approved by the Council and the European Parliament. Commission Regulation 641/2004 lays down implementing rules for the authorization of GM food and feed under European Parliament and Council Regulation 1829/2003. It clarifies what information and data have to be provided to support applications for the authorization of new GM food and feed and the notification of existing products.
Under the new rules for traceability, business operators must transmit and retain information about products that contain or are produced from GMOs at each stage of the placing on the market. Information concerning the presence of GMOs must be transmitted throughout the commercial chain and must be retained for five years. The regulation covers all products, incl. food and feed, containing or derived from GMOs that received an EU authorization, e.g. GM seeds, GM grain, tomato paste and ketchup derived from a GM tomato or starch, oil or flour produced from a GM maize.
On January 14, 2004, the European Commission published Commission Regulation 65/2004 establishing a system for the development and assignment of unique identifiers for GMOs. A unique identifier is assigned to each GMO as a means of indicating its presence and reflecting the specific transformation event covered by the consent or authorization for placing that GMO on the market.
All foods and feed produced from GMOs, including products that no longer contain detectable traces of GMOs must be labeled. The allowable adventitious presence level for EU-approved varieties of GMOs for use in food and feed, is set at 0.9 percent. Above this level, all products must be labeled. Operators must demonstrate that the presence of GM material was adventitious or technically unavoidable. The provision that allowed an adventitious presence level of 0.5 percent for GM varieties, which are not yet formally approved but which have received a positive EU risk assessment, expired in April 2007.
The regulation does not require
labeling of products that are not food ingredients, such as processing
aids. Meat, milk or eggs obtained from animals fed with GM feed or treated
with GM medicinal products do not require GM labeling. For more information
on the labeling of processed products see
GAIN report E47044.
Technology providers can file an application for the authorization of agricultural biotech products under two regulations. Under Regulation 1829/2003, a company can file a single application for the biotech event and all its uses (knows as the "one door, one key" principle). The company submits the application to the competent authority of the Member State where the product will first be marketed. Within 14 days, the Member State must forward the application to EFSA for review. The review conducted applies to all EU Member States.
Alternatively, a company can file an application under Directive 2001/18/EC
for the purpose of marketing a biotech event for cultivation, importation
and processing into different products. While the procedure under this
Directive resembles that of Regulation 1829/2003, there are some
differences. The competent authorities of the Member State in which
the application is submitted perform an assessment. Should they issue
a negative assessment, the applicant's only option is to submit the file in
another Member State. However, if the Member State does issue a
favorable assessment, then the results are shared with the Commission and
all other Member States who may approve the event for marketing within the
EU or raise objections. Should objections be raised, then the
Commission will ask EFSA to conduct a study. From this point on, the
approval procedure resembles that of Regulation 1829/2003.
Austria, Denmark and Italy have taken the lead in pressing the Commission to adopt an EU-wide regulation for the co-existence of biotech crops and conventional and organic agriculture. Along with Germany, each of those countries has drafted co-existence laws that are extremely restrictive in terms of what farmers of biotech crops are required to do. Faced with such challenges, farmers will likely not run the risk of planting biotech crops. Moreover, certain aspects of these laws would appear to violate the internal market rules of the EU which guarantees "free circulation", and is reiterated in Article 22 of Directive 2001/18/EC.
Commission Report: "Communication from the Commission to the Council and
the European Parliament: Report on the implementation of national measures
on the co-existence of genetically modified crops with conventional and
organic farming" (March 9, 2006)