# 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Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division 5.8.1: Toxicity studies of metabolites as referred to in the introduction, point (vii)

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

Supplementary studies, where they relate to substances other than the active substance, are not a routine requirement.
Decisions as to the need for supplementary studies must be made on a case by case basis.

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/A/division/5/division/5.8/division/5.8.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-5/division-5.8/division-5.8.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.