# 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), Article 4: Requirements for the performance of studies for applications submitted under Articles 5(3) and 17(3)

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

1. Toxicological studies shall be conducted in facilities which comply with the:
(a) requirements of Directive 2004/10/EC; or
(b) ‘OECD Principles on Good Laboratory Practice’ (GLP), if carried out outside Great Britain.
The applicant shall provide evidence to demonstrate such compliance.
2. Studies, other than toxicological studies, shall:
(a) comply with the principles of Good Laboratory Practice (GLP) laid down in Directive 2004/10/EC; or
(b) be conducted by organisations accredited under the relevant ISO standard.
3. Information on the study protocols and the results obtained from the studies referred to in paragraphs 1 and 2 shall be comprehensive and include the raw data in an electronic format, suitable for carrying out statistical or other analysis.

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Source: https://www.legislation.gov.uk/eur/2013/503/article/4 (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-503/article-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.