Committee on Petitions 20.03.2009
NOTICE TO MEMBERS
Subject: Petition 0813/2008 by Mr. John Brian (British), on alleged breaches of the general principles governing the activity of the European Food Safety Agency (EFSA) in connection with the examination of the applications for Genetically Modified foods
1. Summary of petition The petitioner alleges that, in carrying out its activity, the European Food Safety Agency (EFSA) would have failed to protect the interests of the European citizens, to guarantee consumer protection and to provide independent scientific advice. The petitioner argues that in examining the applications for Genetically Modified food or crops, EFSA would base its assessment on data provided by the applicants, which would be selective and biased. The petitioner also criticizes the non-transparent way in which EFSA assesses the files and considers that data in such application should be put to public scrutiny. The petitioner asks the European Parliament to have EFSA enforce the highest standards of scientific ethics in its Genetically Modified Organisms (GMO) Panel and in examining GMO applications.
2. Admissibility Declared admissible on 24 October 2008. Information requested from Commission under Rule 192(4).
3. Commission reply, received on 20 March 2009.
The European Food Safety Authority (EFSA) as established by Regulation (EC) No. 178/2002 is a scientific body, independent from the Union Institutions (1) with the main mission to provide scientific advice for the Community's legislation and policies in all fields that have a direct or indirect impact on food and feed safety.
The legislation establishing EFSA provides for a Scientific Committee and ten Scientific Panels which are responsible for providing scientific opinions in the various specialised areas relating to the remit of EFSA, one of which is the GMO Panel. Their members are independent experts, identified following a public call for expression of interest and nominated by EFSA’s Management Board. Internal rules and guidance on declarations of interests, the establishment of Scientific Committee and Panels and implementing measures on transparency and confidentiality requirements and on declarations of interests are published on the EFSA website. The Scientific Panels may involve ad hoc experts in expert working groups who contribute to the preparatory work of the Panels and are covered by the same internal rules as the Panel members.
Members of the scientific panels and ad hoc experts are obliged to complete an annual declaration of interests mentioning possible interests which could impact on the work of the panel. These declarations are published on the EFSA website. Similarly, the declarations of interests for members of working group are also published. In addition, for each meeting, experts are required to declare any interest which may constitute a conflict of interest with respect to the agenda of the meeting. This is reported in the minutes of the meeting which are again published on the website. Due to the fact that all scientists involved in the Scientific Committee and Panels have various interests in the respect of their area of work, it is necessary to differentiate between interests and conflict of interest.
The EFSA GMO Panel evaluates the studies submitted by the applicants. The environmental risk assessment takes place in accordance with the thorough criteria established by the principles of Annex II of Directive 2001/18/EC. The study types to be submitted are defined on the basis of the provisions of Directive 2001/18/EC and Regulation 1829/2003 which require a detailed set of information (2) to be provided in accordance with the published EFSA guidance documents for the risk assessment of GMOs. In the context of its evaluation, the Authority is also entitled to request supplementary data and it may always ask to be assisted by a food assessment body of a Member State. Moreover the EFSA GMO Panel always checks the quality of the tests which in principle must be performed by accredited laboratories respecting Good Laboratory Practice protocols and using internationally recognised OECD standards. Against this background the duration of the studies needed to assess the safety of a product is defined on a case by case basis.
It is also worth mentioning that EFSA's evaluation of studies submitted by applicants reflects normal practice for the risk assessment of authorisation dossiers. This is not only the case for other areas covered by EFSA but is the practice for agencies responsible for the assessment of authorisation dossiers in other areas, such as, the European Medicines Agency (EMEA) and also reflects the situation internationally. Furthermore, it should also be recognised that EFSA's opinions on GMOs are not restricted to the provided data alone, such as applicant dossiers, but also takes into account studies carried out by independent researchers and published in peer review scientific journals. These are systematically identified and referenced in each scientific opinion.
The results of the EFSA assessment, together with other relevant factors, are taken into account in the subsequent risk management decision, proposed by the Commission and taken under a regulatory procedure ensuring close co-operation between the Commission and the Member States.
It must be stressed that these steps are taken with full transparency and active involvement of not only the competent national authority of Member States (3) but also the public at large. Directive 2001/18/EC and Regulation (EC) No 1829/2003 both provide for a public access to the information and data received during the authorisation process and offer the public the possibility to forward comments to the Commission further to the risk assessment and before the adoption of the authorisation decision.
In conclusion, the Commission considers the protection of human and animal health and the environment as a top priority and is committed to ensure that genetically modified seed, food and feed are authorised only when they do not have adverse effects on human health, animal health or the environment. In this context the Commission is confident in the work carried out by EFSA, a judgment which has been shared even recently by the vast majority of Member States and the European Parliament. The Commission will continue to fulfil its responsibilities in the implementation of this framework which is probably the strictest in the world and which we constantly monitor for possible improvements.
(1) 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
(2) See Annex III of Directive 2001/18/EC outlining information required in the notification
(3) See Articles 6(4)/18(4) of Regulation(EC) No 1829/2003