# Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (Text with EEA relevance), Division 3.2.2.5: Reproduction toxicity studies (including prenatal developmental toxicity)

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

To identify possible impairment of male or female reproductive function or harmful effects on progeny resulting from the administration of the active substance, studies of reproductive function must be carried out by:
(1)two generation reproduction toxicity study; and
(2)prenatal developmental toxicity study (teratogenicity study).
For new trials validated alternative methods reducing the use of animals can be used.

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Source: https://www.legislation.gov.uk/eur/2008/429/annex/II/division/3/division/3.2/division/3.2.2/division/3.2.2.5 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-429/annex-II/division-3/division-3.2/division-3.2.2/division-3.2.2.5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.