Implement the biotech crop authorization process

 In 2001, the European Commission published a report based on 81 research projects funded by the Commission (€ 70 million) over 15 years. The report found that biotech crops did not have “any new risks to human health or the environment beyond the usual uncertainties of conventional plant breeding.  Indeed, the use of more precise technology and the greater regulatory scrutiny probably make them even safer than conventional plants and foods6 ”.
 
Despite the scientific findings, in 2004 the European Commission acknowledged that as far as agricultural biotechnology is concerned: “…Europe’s position is declining as a consequence of the political inertia caused by the polarised and increasingly heated debate between opponents and advocates…7” As a consequence of this political inertia, the stringent system for authorizing new biotech crops in the EU is not working as intended.
 
In spite of the fact that companies are complying with regulatory requirements and that the body responsible for scientific assessment, the European Food Safety Authority (EFSA), has issued a number of positive opinions on product safety, no product has yet been approved in the EU for cultivation since the new regulatory framework was adopted in 2001. In addition, approvals of products for use in animal feed and food also face undue delays in spite of positive opinions on safety from EFSA.
 
The approval process is not working properly for three main reasons:
 
 1. The safety assessment part of the approval process managed by the EFSA GMO Panel is functioning very slowly.
 
 2. The European Commission Directorates responsible for managing the approval process are not submitting proposals for decisions to the Regulatory (Member State) Committees within the times prescribed by the regulations.
 
 3. Member State representatives at the Regulatory Committee and Council levels are not following EFSA opinions on product safety.
 
Suggested solutions
  
 1. As a matter of priority, the EFSA GMO Panel should focus its capacity on applications for product approvals, and deliver opinions in timeframes consistent with those prescribed in the regulations. Ad hoc self-tasking activities should be reduced until the backlog of applications is removed.  Additional resources should be provided to EFSA to manage the increasing number of  applications.
 
 2. The European Commission should propose draft approval decisions to Member States according to their regulatory obligations with respect to legally binding timelines.
 
 3. Member States should act in a manner consistent with their EU and International obligations, and demonstrate confidence in the regulatory process they established by making decisions on the basis of EFSA’s scientific opinions.
 
 4. The European Commission should ensure that, for biotech products authorized in the EU, Member States do not restrict farmers’ access to such products through the use of arbitrary and illegal bans or through the adoption of discriminatory national or local coexistence rules.

6 European Commission, “Future Challenges for Life Sciences Research”, European Group of Life Sciences (EGLS), Sep 2004
7 European Commission-sponsored research on the safety of Genetically Modified organisms – a review of results, http://ec.europa.eu/research/quality-of-life/gmo/
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