EU Regulations

The European Commission terminated the preparation of regulations for the biotechnological sector in 2003. This was in accordance with what was established by the White Book 2000. This sector is directly connected to more general regulations on food safety in the community, whose basic procedures are described in Regulation no. 178/2002. The Regulation “sets out principles and general requirements on food safety, establishes the European Food Safety Authority and fixes procedures in the field of food safety”.

Community regulations were completed by (EC) Regulation no. 1829/2003 of the European Parliament and of the Council on “genetically modified foods and animal feed” and by (EC) Regulation no. 1830/2003 of the European Parliament and of the Council on "traceability and labelling of genetically modified organisms and traceability of foods and animal feed obtained from genetically modified organisms which also contains an amendment to Directive 2001/18/EC". These regulations have been added to previously existing community regulations, such as Directive 2001/18/EC of the European Parliament and of the Council on "Deliberate emission of genetically modified organisms in the environment which annuls Directive 90/220/EC", which provides to authorize procedures for experimental purposes and the distribution of transgenic cultures.

Currently, whoever wishes to distribute a GMO, or products obtained from GMOs, on the market for human and/or animal consumption can place an authorization request through the relevant national authorities of a member state in accordance with Reg. no.1829. Unlike what occurred with requests presented in accordance with Directive 2001/18/EC, the relevant national authorities inform the European Food Safety Authority (EFSA), which was established with EC Regulation no.178/2002. They provide it with all the documentation. The EFSA is obliged to immediately inform the European Commission and other member states about the request, providing them with all the relevant documentation. A summary of the notified request is published on the EFSA web site. The EFSA also provides the European Commission and member states with its scientific and technical opinion on the request and on it the decision for the authorization will be based.

The implementation of Regulation no. 1829 has raised some perplexity from several member states due to its clear overlapping with Directive 2001/18/EC. In particular, for GMOs it would have been logical that the regulation concerning the food and animal feed sector would only deal with such products. The European Commission, instead, proposed to include also the environmental release of GMOs destined to become food or animal feed either directly or indirectly. GMOs should have been regulated by Directive 2001/18/EC, while the Regulation should only have dealt with GMO by-products, composed and/or containing food GMOs.

In the legal framework that authorizes GMO distribution on the market, the Regulation’s positive contribution is that it provides a more careful attention towards the safety of these products. Among the information required is a specific analysis (supported by adequate scientific data) to prove a substantial equivalence of the food’s features with respect to the traditional product. This is “taking into account the accepted limits and the natural variations of such features” (art. 5, paragraph 3f)). It is worth remembering that although it was amended through the annulment of some articles, Regulation no. 258/97 on “New products and new food ingredients” is still in force. In particular, the notification procedure on genetically modified organisms based on the principle of substantial equivalence has been abandoned to embrace the new approach of Regulation no.1829/2003. This is related to an evaluation process that guarantees clarity, transparency and a harmonized authorization system.

To make the sector’s regulation framework more complete, in 2003 the EU Commission issued Recommendation no. 2003/556/CE containing “Guidelines for the development of national strategies and improved practices to guarantee coexistence between conventional agriculture, agriculture using biological methods and genetically modified cultures”. In addition, in 2004 two regulations were issued. The first is Reg. (EC) no. 65/2004 of the Commission which “establishes a system for defining and assigning single indicators for GMOs” and the second is Reg. (EC) no. 641/2004 of the Commission which contains “implementation standards of Reg. (EC) 1829/2003 for new GMO food and animal feed authorization requests; notification of preexistents and accidental presence of GM material, whose risk need to be favourably evaluated”.