European Union | BCH-LAW-EU-5623 | Biosafety Law, Regulation, Guidelines and Agreements | Biosafety Clearing-House

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Biosafety Law, Regulation, Guidelines and Agreements (LAW)

published: 24 May 2004 last updated: 10 May 2010
Amendment
No
General information
Commission Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation
EN
Legislative details
Law
Regional / Multilateral
  • Europe - European Union member states
Regulation (EC) No 641/2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 provides further details on the applications for authorisation of GM food and feed, including the method(s) of detection, sampling and event specific identification of the transformation event, as provided for in articles 5(3) and 17(3) of Regulation (EC) No 1829/2003.

In particular Annex I of Regulation (EC) No 641/2004 on "method validation" provides detailed technical provisions on the type of information on detection methods that shall be provided by the applicant and that is needed to verify the preconditions for the fitness of the method. This includes information about the method as such and about the method testing carried out by the applicant.

Annex I of Regulation (EC) No 641/2004 also confirms that the validation process will be carried out by the CRL according to internationally accepted technical provisions. All guidance documents referred to in this Annex or produced by the Community Reference Laboratory (CRL) are to be made available by the CRL.
EN
07 Apr 2004
Regulatory contact information
Additional Information
EU validated detection methods for GM food/feed applications submitted under Regulation (EC) No 1829/2003 are available at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm
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