# 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Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division (vii)

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

It may be necessary to conduct separate studies for relevant metabolites (especially toxins), where these products can constitute a relevant risk to non-target organisms and where their effects cannot be evaluated by the available results relating to the micro-organism. Before such studies are performed, the applicant shall seek agreement of the competent authorities on whether such studies need to be performed and, if so, the type of study to be conducted. The information from Sections 5, 6 and 7 has to be taken into account.

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/B/division/8/division/1/division/vii (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-8/division-1/division-vii
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.