Scientific report of EFSA prepared by the GMO Unit on Public Consultation on the Updated Guidance Document of the Scientific Panel on Genetically Modified Organisms (GMO) for the risk assessment of genetically modified plants and derived food and feed.
Question number: EFSA-Q-2009-00500Background
On 22 May 2008, the EFSA Scientific Panel on Genetically Modified Organisms (GMO) adopted the draft updated version of its Guidance Document for the risk assessment of genetically modified plants and derived food and feed ( See Annex A: Updated Guidance Document for the Risk Assessment of Genetically Modified Plants and derived food and feed), in the light of several years of experience in the risk assessment of GMO applications and of the outcome of the Panels’ self-tasking activities. In line with EFSA’s policy on openness and transparency, and in order to allow the scientific community and stakeholders to comment on its work, EFSA consulted the public on this document. On 21 July 2008 the draft updated guidance document was published for public consultation until the 21 of September 2008.
The updated guidance document formed the basis for the establishment of a legal framework for EFSA’s GMO assessment by the European Commission (EC) and the Member States. In the frame of enhancing that process, the comments received during EFSA’s public consultation were forwarded to the EC. EFSA committed to publish an evaluation report on the comments received.
A draft working document for the establishment of this legal framework was prepared by the EC based on the updated guidance of the GMO Panel, on comments of stakeholders and Member States which were provided during the public consultation of EFSA as well as further discussions. EFSA was formally consulted on this document by the Commission on 23 February 2009 and adopted the document with proposed modifications (see Annex B: Answer from EFSA to the consultation of DG SANCO on Rules for applicants for the preparation and presentation of applications to be submitted under Regulation (EC) No 1829/2003 on GM food and feed) [1].
Comments received
At the deadline of its public consultation EFSA had received 357 submissions, from 19 interested parties (non-governmental organisations, industry organisations and national assessment bodies and competent authorities). EFSA has taken into account and answered all comments provided in the electronic template in a summarized form in its Scientific Report on “Public Consultation on the Updated Guidance Document of the Scientific Panel on Genetically Modified Organisms (GMO) for the risk assessment of genetically modified plants and derived food and feed”. The list of the comments received can be found – without reference to individual submitters – as Annex C of this report.
- Report of EFSA on public consultation_GMO guidance.pdf (0.2Mb)
- Annex A (1.3Mb)
- Annex B (0.4Mb)
- Annex C (0.8Mb)