# 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 (Text with EEA relevance), Division C: Information required about the method development and the method optimisation:

Extent: E+W+S+N.I.

1..primer pairs tested (in the case of a PCR-based test): justification shall be given of how and why the proposed primer pair has been selected;
2..stability testing: experimental results from testing the method with different varieties shall be provided;
3..specificity: the applicant shall submit the full sequence of the insert(s), together with the base pairs of the host flanking sequences needed to establish an event-specific detection method. The RL shall enter these data in a molecular database. By running homology searches, the RL will thus be in a position to assess the specificity of the proposed method.

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Source: https://www.legislation.gov.uk/eur/2004/641/annex/I/division/3/division/C (the official version)
Page: https://openlegislation.uk/eu-regulation-2004-641/annex-I/division-3/division-C
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.