Genetically Modified Organisms: Authorisation Procedures for New GMOS (link)

May 27, 2005

Brussels, 26 May 2005

Full text of Document 9253/05
Suite of documents 9253/05

Under the procedures established pursuant to Regulation (EC) No 1829/2003 for assessing the health and environmental risks posed by a genetically modified product, the European Food Safety Authority's specialist scientific group responsible for considering marketing applications (the GMO panel) gives its opinion after examining the scientific documentation supplied by the applicant. The EFSA thus does not conduct any scientific tests to ascertain whether new genetically modified products are safe to use; it merely examines the scientific data supplied by applicants.

It should be pointed out that a similar procedure applies for GMO marketing applications submitted under Directive 2001/18/EC , where the Member State receiving an application has to form its judgment on the basis of trial data supplied by the applicant.

Mention should be made here of the step already taken by one Member State, as regards molecular characterisation of products, in commissioning a public laboratory to verify applicants' data by means of testing.

In our view, the EFSA should itself be able to perform the analysis required for independent assessment of the safety of products for which marketing authorisation is sought, either by making its own checks on data supplied or, if necessary, by having further investigations carried out.


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