# Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 (Text with EEA relevance), Division C: The applicant shall provide the following information about the method development and the method optimisation:

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

1..primer pairs tested and probe, if appropriate, including a justification as to how and why the proposed primer pair has been selected;
2..stability testing, which shall be established through the submission of experimental results from testing the method with different plant varieties;
3..specificity, which shall be established through the submission of the full sequence of the insert(s) in a standardised electronic format, together with the base pairs of the host flanking sequences so as to enable the reference laboratory to assess the specificity of the proposed method by running homology searches in a molecular database;
4..precision, the relative repeatability standard deviation shall be less than or equal to 25 % related to mass fraction over the whole dynamic range of the method.

---
Source: https://www.legislation.gov.uk/eur/2013/503/annex/III/division/3/division/3.2/division/C (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-503/annex-III/division-3/division-3.2/division-C
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

