# 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 E: The applicant shall provide a complete and detailed description of the method.

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

The following points shall be clearly addressed by the applicant:
1..Scientific basis: the applicant shall provide an overview of the principles of how the method works. This overview shall include references to relevant scientific publications.
2..Scope of the method: the applicant shall indicate the matrix(es) (for example, processed food, raw materials), the type of samples and the percentage range to which the method may be applied.
3..Operational characteristics of the method: the required equipment for the application of the method shall be specified, with regard to the analysis as such and the sample preparation. Further information of any specific aspects crucial for the application of the method shall also be included.
4..Protocol: the applicant shall provide a complete optimised protocol of the method. The protocol shall present all the details as required to transfer and apply the method independently in other laboratories.
5..A prediction model (or a similar tool) needed to interpret results and to make inferences shall be described in full details. Instructions for the correct application of the model shall be provided by the applicant.
6..Breeding schemes that are to be applied for the production of genetically modified food and feed and their impact on the interpretation of results shall be provided by the applicant.

---
Source: https://www.legislation.gov.uk/eur/2013/503/annex/III/division/3/division/3.1/division/E (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-503/annex-III/division-3/division-3.1/division-E
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.