Comments on the ‘Guidance on the environmental risk assessment of GM plants’ and on the ‘Scientific opinion on the assessment of potential impacts of GM plants on NTOs’

The European Commission intends to develop a legally binding text that can serve as the basis for applicants of GM authorizations, for Member States and for EFSA when assessing the environmental risk of genetically modified (GM) plants. The guidance document on the environmental risk assessment (ERA) of GM plants that was recently published by EFSA, serves as the basis for this document. COGEM has been asked by the Dutch Ministry of Infrastructure and the Environment to advise on the recently published guidance document. Given the time available and the complex nature of the document, COGEM has focused on major concerns.

The guidance document gives a broad overview of all aspects of the ERA and describes different angles that can be used in the ERA. It offers insight in the considerations on the different aspects of the ERA and lists various scientific views on these aspects. However, a consequence of the broadness of the guidance document is that its use as a guidance document is limited. It does not offer protocols or specification of the objectives which have to be fulfilled at each stage of the risk assessment. Therefore, the present document does not meet the qualifications needed for a binding guideline. An adapted version of the document is excellently suited as a background document or reference for the ERA of GM plants, but should not be transformed into a legally binding provision.

Documents that are focused on providing guidance for specific categories of GM plants, e.g. herbicide tolerance, insect resistance or changed metabolic pathways are more suited as guidance documents. Therefore, COGEM proposes the development of legally binding guidance documents that are more precise and apply to specific categories of GM plants.

In addition, COGEM would like to emphasize that the task of identifying protection goals and setting ‘limits of concern’ should not be left to the applicant. Protection goals depend on policy goals and should therefore be identified in a political process. The identification of protection goals and the translation of these protection goals in assessment endpoints and setting the ‘limits of concern’ should be done by the competent authorities.