# 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 3.2.1: Molecular characterisation

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

Evaluation of the characteristics and previous use of the donor and the recipient plant shall be a key element to identify the need for specific analyses, such as the occurrence of specific toxins, or allergens in the unmodified recipient plant which may be unintentionally increased as result of the genetic modification.
Transformation protocols, molecular characterisation strategies and the specificity and sensitivity of the methods used shall be discussed by the applicant in relation to the intentional and possibly unintentional insertion and expression of gene sequences.
Where sequence analysis has identified a potential hazard, the applicant shall demonstrate how approaches like bioinformatic analysis, compositional/agronomical analysis and possibly animal feeding trials with the whole genetically modified food and feed contribute to the safety assessment. The value of the results obtained shall be evaluated in the light of the available knowledge on the structure and function of genomic databases of the crop species in question or related species.
In cases of GM plants containing stacked transformation events, the additional risks possibly arising from the combined effects of the stacked genes shall be evaluated.

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Source: https://www.legislation.gov.uk/eur/2013/503/annex/II/division/II/division/3/division/3.2/division/3.2.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-503/annex-II/division-II/division-3/division-3.2/division-3.2.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.