4) Further Commission reply, received on 1 September 2009.
The petition
The petitioner seeks to cast doubt on the activities of the European Food Safety Authority (EFSA), especially with regard to genetically modified organisms (GMO's).
The Commission's observations
The Commission considers the protection of health and the environment as a top priority and is committed to ensuring that genetically modified (GM) seed, food and feed are authorised only when they are not likely to have adverse effects on human health, animal health or the environment.
To achieve this objective the EU has in place a strict legislative framework on genetically modified organisms. This legislation, and particularly Regulation (EC) No. 1829/2003[1] and Directive 2001/18/ EC[2] of the European Parliament and the Council, foresee the safety of the product as the first requirement for its placing on the market. More specifically any genetically modified organism, before being placed on the market within the Community, has to undergo a safety assessment of high standards. This risk assessment is performed by the European Food Safety Authority (EFSA), a scientific agency independent of the Commission and established by Regulation (EC) No. 178/2002[3] of the European Parliament and the Council. A specific EFSA GMO Panel, a body composed of renowned scientists chosen for their competence in the relevant fields is responsible for the evaluation. The Panel is assisted by ad hoc experts and its work is based on internationally agreed methods. Concerning the basis of this risk assessment, the EU GMO legislation, Directive 2001/18/EC and Regulation (EC) No 1829/2003 of the European Parliament and Council are clear that applicants are obliged to provide studies, including independent peer-reviewed studies to demonstrate that the GMOs do not have adverse effects on human or animal health or the environment. Annex II of the Directive establishes very detailed principles for the conduct of the environmental risk assessment[4], while Annex III sets out a thorough list of information that is required for all notifications.
These requirements are further expanded in the detailed EFSA guidance document on genetically modified organisms for the risk assessment of genetically modified plants and derived food and feed. Test methods used have either to be fully justified or be those described by OECD or the European Commission and the studies have to be carried out according to the principles of Good Laboratory Practice (GLP). The petitioner does not say that the system is flawed but that some science submitted by applicant is so. In this context, it is also worth mentioning that the Commission is finalising a proposal for a Regulation that will further specify the requirements for applications submitted under Regulation (EC) No 1829/2003 and notably requirements regarding the information to be provided with regard to food and feed safety assessment. This proposal is based on an update of the EFSA guidance mentioned above as well as on intensive discussions that took place with Member States. Stakeholders have also been consulted. In accordance with the provisions of Regulation (EC) No 1829/2003, EFSA has recently been consulted on the outcome of this process and the reaction of EFSA is published on its website.
The Decision-making procedure as foreseen both in Directive 2001/18/EC and Regulation (EC) No 1829/2003 provides for extensive public access to the information and data received during the authorisation process and offers the public the possibility to comment on the application in the light of the risk assessment and before the adoption of the authorisation decision. Before submitting a proposal for authorisation, the Commission takes into consideration these comments of the public. Comments from the public may concern not only strictly scientific aspects related to the product but also other relevant factors, including some of the considerations raised in the petition. All this information is available on the websites of the Directorates- General for Health and Consumers and for the Environment.
Public disclosure of GMO dossiers is subject to the confidentiality and data protection provisions of the above-mentioned legislation. The evaluation of the confidential nature of the dossier is conducted by the Commission by means of an ad hoc decision on the basis of the said legislation and EFSA has to respect the Commission decision.
The procedure does not block independent research as is apparent by the considerable non-proprietary literature cited by EFSA in its opinions on GMOs. Neither the European Commission nor EFSA have any influence on how companies award contracts for carrying out independent research, a situation similar to other areas of endeavour.
[1] See Articles 6(4)/18(4) of Regulation(EC) No 1829/2003 [1] Regulation (EC) No 182/2003 of the European Parliament and of the Council of 22 Septemeber 2003 on genetically modified food and feed, OJ L 268, 18.10.2003 [2] Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, OJ L 106, 17.4.2001 [3] Regulation (EC) No 178/2002 of the Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, OJ L 31, 1.2.2002 [4] Complemented by Decision 2002/623/EC