EFSA concludes guidance document for the risk assessment of genetically modified plants and derived food and feed

Following fruitful collaboration and consultation with stakeholders, the Scientific Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) has concluded and published its guidance document for the risk assessment of genetically modified (GM) plants and derived food and feed. The guidance document is the result of a request submitted to EFSA by the European Commission for comprehensive guidance to applicants wishing to introduce GMOs or derived products to the EU market in accordance with the Regulation on GM food and feed*. This guidance document was compiled by the GMO Panel, together with some members of other EFSA Scientific Panels and ad hoc experts.

Before any GMO or derived product can be placed on the EU market, it is required to pass an approval system in which its safety vis-à-vis humans, animals and the environment is thoroughly assessed. In line with the provisions of the Regulation on GM food and feed, the European Commission asked EFSA to develop and publish a detailed guidance document to assist applicants in the preparation and presentation of applications for the authorisation of GM food and/or feed.

Upholding its commitment to involve stakeholders in the risk assessment process, the guidance document has substantially benefited from comments received during a 4-week period of public consultation as well as feedback received during a stakeholder consultation held in May 2004**. It provides detailed guidance for the preparation and presentation of applications within the framework of the Regulation on GM food and feed, and of Directive 2001/18/EC*** on the deliberate release into the environment of GMOs. This document therefore covers the full risk assessment of GM plants and derived food and feed. Issues related to risk management of GMOs (traceability, labelling, co-existence) are outside the remit of the GMO Panel. The Panel will regularly review this guidance in the light of experience gained, technological progress and scientific developments.

Notes to the Editor

  Timeline for the preparation of the guidance document
27 October 2003 Question submitted by European Commission
7 April 2004 Publication of draft guidance document on the EFSA website
9 May 2004 Deadline for interested parties to submit written comments through online consultation process.
25 May 2004 Stakeholder Consultation meeting
24 September 2004 Adoption of Guidance Document by GMO Panel
15 October 2004 Advance copy sent to participants of 25 May stakeholder meeting
8 November 2004 Final editing of Guidance Document

For applications submitted within the framework of Regulation (EC) 1829/2003, the list and summaries of the applications are published on the EFSA website

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