# 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 1.4.4.2: Animal studies with respect to reproductive and developmental toxicity testing

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

When information required in Sections 1.4.1, 1.4.2 and 1.4.3 on the genetically modified food and feed suggest the potential for reproductive, developmental or chronic toxicity or in case of indications of adverse effects from the 90-day feeding study in rodents (such as functional and/or histological modifications of nervous, endocrine, reproductive or immunological tissues/organs), appropriate testing shall be performed. Protocols for reproductive, developmental and chronic toxicity testing (see Table 1 of Section 1.7) may be adapted for the purposes of testing the whole genetically modified food and feed.
Given that the 90-day feeding study in rodents is only designed to detect effects on adult reproductive organ weights and histopathology and that it does not detect other effects on reproduction or development, testing of the whole food and feed beyond a 90-day rodent feeding study shall be conducted where hazards in this respect have been identified.

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Source: https://www.legislation.gov.uk/eur/2013/503/annex/II/division/II/division/1/division/1.4/division/1.4.4/division/1.4.4.2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-503/annex-II/division-II/division-1/division-1.4/division-1.4.4/division-1.4.4.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.