# 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 1.2.1.3: Source of nucleic acid(s) used for transformation, size and intended function of each constituent fragment of the region intended for insertion

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

The applicant shall provide information on the donor organism(s) and on the nucleic acid(s) sequence(s) intended to be inserted in order to determine whether the nature of the donor organism(s) or the nucleic acid sequence(s) may trigger any safety issue.
Information regarding the function of the nucleic acid region(s) intended for insertion shall comprise the following elements:
(a)the complete sequence of the nucleic acid(s) intended to be inserted, including information on any deliberate alteration(s) to the corresponding sequence(s) in the donor organism(s);
(b)the history of safe use of the gene product(s) arising from the regions intended for insertion;
(c)data on the possible relationship of the gene products with known toxins, anti-nutrients and allergens.
Information regarding each donor organism shall comprise:
taxonomic classification;
history of use regarding food and feed safety.

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Source: https://www.legislation.gov.uk/eur/2013/503/annex/II/division/II/division/1/division/1.2/division/1.2.1/division/1.2.1.3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-503/annex-II/division-II/division-1/division-1.2/division-1.2.1/division-1.2.1.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.