# 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 demonstrate that the method(s) fulfils the following requirements:

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

1..The method(s) shall be specific to the transformation event (hereafter referred to as ‘event-specific’) and thus shall only be functional with the genetically modified organism or genetically modified based product considered and shall not be functional if applied to other transformation events already authorised; otherwise the method cannot be applied for unequivocal detection/identification/quantification. This shall be demonstrated with a selection of non-target transgenic authorised transformation events and conventional counterparts. This testing shall include closely related transformation events.
2..The method(s) shall be applicable to samples of the food or feed, to the control samples and to the certified reference material.
3..The applicant shall take into consideration the following documents for the development of the detection method:
(a)Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — General requirements and definitions: ISO 24276;
(b)Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Nucleic acid extraction: ISO 21571;
(c)Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Quantitative nucleic acid based methods: ISO 21570;
(d)Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Qualitative nucleic acid based methods: draft European standard ISO 21569.
4..The method shall also take into consideration the more detailed requirements set out in the common criteria set by the reference laboratory... for minimum performance requirements for analytical methods for GMO testing. These criteria are part of the guidance provided by the reference laboratory.

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