# Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division: Circumstances in which required

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

When any result of an in vivo study in somatic cells is positive, in vivo testing for germ cell effects may be justified. The necessity for conducting these tests will have to be considered on a case-by-case basis, taking into account other relevant information available including use and expected exposure. Suitable tests would need to examine interaction with DNA (such as the dominant lethal assay), to look at the potential for inherited effects and possibly make a quantitative assessment of heritable effects. It is recognised that in view of their complexity, the use of quantitative studies would require strong justification.

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/B/division/5/division/3/division/5.5/division/2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-5/division-3/division-5.5/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.