Comments on the EFSA draft guidance for environmental risk analysis of GM plants

Recently, the EFSA GMO Panel published a draft guidance document for the environmental risk assessment of genetically modified plants for public consultation of the European member states and stakeholders. The document ‘Guidance on the environmental risk assessment of genetically modified plants’ provides the most recent guidance document for the Environmental Risk Assessment (ERA) of genetically modified (GM) plants submitted within the framework of Regulation (EC) No. 1829/2003 on GM food and feed or under Directive 2001/18/EC on the deliberate release into the environment of GMOs. EFSA states that the document aims to provide guidance to applicants as well as risk assessors for assessing potential effects of GM plants on the environment and the rationale for data requirements in order to complete a comprehensive ERA of GM plants.

COGEM welcomes the initiative of the EFSA to renew its guidance and considers this an important step towards harmonization of risk analysis in the EU. COGEM appreciates the extensive amount of effort that is being made to realize this document and acknowledges the difficulties in the task to draw up a guideline which has to cover all aspects of the ERA. However, after assessing the guidance document, COGEM is of the opinion that the document is inadequate in providing clear criteria and methods for the ERA. A series of important discussion points remains unanswered. Given the short time available for commenting on the guidance document, COGEM has focused on major concerns.