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22 September 2009

EFSA holds two-day conference to debate GMO risk assessment

The European Food Safety Authority (EFSA) held a two-day conference on GMO risk assessment for human and animal health and the environment in Brussels on 14-15 September 2009, bringing together risk assessors from EU Member States, risk managers, and representatives from stakeholders including industry, consumer and environmental groups from the EU and beyond.

Opening the conference, EFSA Executive Director Catherine Geslain-Lanéelle reaffirmed EFSA’s role as a provider of independent scientific advice on GMOs. “EFSA is neither pro-GMO nor anti-GMO,” she said. She acknowledged that there exists a significant divergence of opinion among various actors in the field of GMOs in the EU and low social acceptability. It was important that the conference clarified EFSA’s role in the risk assessment of GMOs. “We are here not only to inform but also to listen and learn. We want to get as wide a range of views and experiences as possible,” she said. The Commission’s Director-General for Health and Consumers DG Robert Madelin welcomed the conference and said scientists can help regulators make better decisions. He said the EU needed to continue to open up the risk assessment process to integrate public concerns and imbed it in a global context.

Day 1: Assessing the risks for human and animal health and the environment

On the first day, experts from EFSA’s GMO Panel and the GMO Unit presented the EU legal framework for GMOs and some of EFSA’s updated guidelines on the risk assessment of GM plants, which are developed in the context of mandates from the European Commission and to reflect the latest scientific state of the art. Specific and detailed guidelines ensure greater clarity for applicants regarding data requirements.

Howard Davies from the GMO Panel, presenting EFSA guidance related to food and feed safety, stressed that this was defined in close consultation with Member States and stakeholders. EFSA participated in several consultation meetings and held a public consultation on the guidance before adoption. The updated guidance is currently being discussed by the European Commission (EC) and Member States in view of adoption as an annex to an EC regulation. It has been developed to include more detailed data requirements from applicants, for example, concerning field trials, as highlighted by Claudia Paoletti from the GMO Unit.

The environmental risk assessment (ERA) of GM plants is a complex area where science is evolving and EFSA’s guidelines in this field are currently being updated to take into account latest scientific developments. GMO Panel experts Salvatore Arpaia and Jeremy Sweet presented two of the main topics related to the new ERA guidelines: the assessment of effects on non-target organisms and the assessment of long-term environmental impacts. Andreas Heissenberger of Austria’s Environment Agency presented Austria’s scientific view on environmental risk assessment (ERA). He concluded that while Austria endorses EFSA’s case-by-case approach, it believes the ERA is based on insufficient data and he provided a detailed view on how it could be improved. EFSA will consider inputs from the EC, Member States and stakeholders when finalising its updated guidelines.

The aim of the new guidelines is to strengthen and streamline GMO risk assessment processes, contributing to increase their efficiency and transparency. EFSA’s risk assessment is only one part of the EU regulatory framework on GMOs, as highlighted by Chantal Bruetschy, Head of the Commission’s Unit of Biotechnology, Pesticides and Health, who explained the legal provisions on Post Market Environmental Monitoring, as well as its relation with the risk assessment carried out by EFSA and also with the initial environmental risk assessment carried out by Member States.

Day 2: The impact of GM crop cultivation on the environment

The second day began with presentations from the Organisation for Economic Cooperation and Development (OECD) and the Joint Research Centre of the European Commission (JRC). EFSA works in close liaison with the scientific community and international bodies in the field of GMO risk assessment. Peter Kearns from the OECD illustrated risk assessment from a global perspective and presented the work of the OECD Working Group on Biosafety.

Emilio Rodriguez Cerezo from the JRC focused on the impact of GM crops presenting an analysis of the experiences in the cultivation of Bt maize during the past 10 years in Spain and showed figures from various Spanish regions on reduced use of insecticides and yield increase. Similar experiences of farmers on GM cultivation were shared by Esther Esteban Rodrigo of Spain’s Ministry of Environment, Rural and Marine Affairs. Spain has practical experience in GM crop cultivation and is a Member State working closely with EFSA in environmental risk assessment of GMO applications.

Representatives from stakeholder organisations were also invited to the conference to present their views. Helen Holder from Friends of the Earth recognised that there had been improvements in EFSA’s risk assessment work, but reported some outstanding concerns of her organisation regarding environmental risk assessment and expressed criticism of some of EFSA’s scientific opinions on GMOs. EFSA is holding one of its regular meetings with NGOs on October 2 this year for further dialogue on a number of specific GMO issues.

Presenting the views of EU farmers, Copa-Cogeca’s Director of Commodities and Trade, Arnaud Petit, said farmers wanted to keep the option of choosing between GM, conventional or organic farming. The biotechnology industry, represented by Willy De Greef of Europabio, European Association for Bioindustries, asked for the existing experiences of the safe use of GM crops to be better taken into consideration in EU risk assessment and called for a clearer distinction between risk research and risk assessment.

Closing the conference, the Commission’s Director-General for the Environment, Karl Falkenberg, said the Commission valued the work that EFSA carries out as the body providing scientific advice to support its decision making.
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