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National Node of the BCH
Law, Regulation or Guideline
Record information and status
Record ID
5623
Status
Published
Date of creation
2004-05-24 10:22 UTC (Guy.VAN-DEN-EEDE@ec.europa.eu)
Date of last update
2010-05-10 14:49 UTC (Guy.VAN-DEN-EEDE@ec.europa.eu)
Date of publication
2010-05-10 14:49 UTC (Guy.VAN-DEN-EEDE@ec.europa.eu)

General Information
Country
  • European Union
Jurisdiction
  • European Union
Title of document
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
Legislative details
Type of document
  • National Law
Subject areas
  • Competent National Authorities and National Focal Points
  • Confidential Information
  • Handling, transport, packaging and identification
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for processing
  • Public awareness and participation
  • Risk assessment and management
Types of LMOs addressed
  • All types of organisms
Brief description of the document including objective and scope:
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.
Date of entry into force
2004-04-07
Document details
Document text
EN
regulation ec-641-2004.pdf (145 KB)
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
Regulatory contact information
Contact person
European Commission - Health and Food Safety Directorate General SANTE
Rue Belliard, B232
Brussels
Belgium, 1040
Phone:+32 2 2962362
Fax:+32 2 2964736
Email:chantal.bruetschy@ec.europa.eu
Url:European Commission - Health and Food Safety Directorate General SANTE
European Commission Joint Research Centre (JRC)
Retieseweg 111
Geel
Belgium, 2440
Phone:+32 14 571722
Email:hendrik.emons@ec.europa.eu
Url:European Commission Joint Research Centre (JRC)
Additional 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
Other relevant website address or attached documents