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European Union: Evaluation of Legislation on GMOs

(Nov. 16, 2011) On October 28, 2011, the European Commission released the findings of two independent evaluations of the European Union's general legal framework on genetically modified organisms (GMOs). GMOs are defined under EU law as those plants or animals that have acquired a new property after artificial modification of their genetic features. Food and food for animal feed that contain GMOs are referred to as genetically modified food and feed, respectively. The evaluations were conducted at the request of the European Commission in order to assess the effectiveness and efficiency of the EU legal regime, review its implementation by the EU Member States, and examine the recent initiatives undertaken by the Commission in the field of cultivation of GMOs. (Press Release, IP/11/1285, European Commission, GMOs: EU's Legislation on the Right Track, Evaluation Reports Conclude (Oct. 28, 2011).)

The evaluations were published as two voluminous reports, composed of 238 and 137 pages, respectively. The first report assessed the two basic legal instruments governing GMOs: Directive 2001/18/EC on the deliberate release into the environment of GMOs, and Regulation No. 1820/2003, which establishes procedures for the authorization, supervision, and labeling of GMOs. Under EU rules, a GMO may be released into the environment or placed in the market provided that three conditions are met: a) an application is filed; b) a risk assessment on the possible adverse effects on human health and the environment is completed; and c) prior authorization is obtained. The authorization is not granted unless it can be shown that the particular GMO does not have adverse effects on human and animal health and the environment. (Id.)

The second report focused on the Commission's 2010 adoption of a package of measures on GMO cultivation, which includes a recommendation on the co-existence of genetically modified and non-genetically modified plants and a regulation addressing the issue of low-level presence of unauthorized GMOs in feed products imported into the EU. (Id.)

Both reports, based on extensive consultation with stakeholders and pertinent national authorities, concluded that, in general, the existing EU rules enjoy broad support across the EU and meet their salient objectives — to protect the environment and human and animal health and to ensure the smooth functioning of the internal market. They did note, however, that “the authorisation system could be more efficient, GMO cultivation would benefit from more flexibility and the risk assessment process from further harmonisation.” As far the new initiatives adopted by the Commission are concerned, they are “heading in the right direction.” (Id.)

The Commission announced that it will come up with a proposal dealing with more precise requirements for the submission of authorization applications for imported products for food and feed use. It will also revise the guidelines on environmental risk assessment to ensure that they are more specific and contain sufficient detail. Finally, the Commission intends to make the monitoring of the implementation of food safety and GMO legislation by EU Members and companies a priority. (Id.)