# 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Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division (iv): Any relevant metabolites (i.e. of concern for human health and/or the environment) formed by the test organism under any relevant environmental conditions shall be characterised. If relevant metabolites are present in or produced by the micro-organism, data as outlined under Section 7 of Part A of this Annex may be required, if all of the following conditions are met:

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

the relevant metabolite is stable outside the micro-organism, see point 2.8, and
a toxic effect of the relevant metabolite is independent of the presence of the micro-organism, and
the relevant metabolite is expected to occur in the environment in concentrations considerably higher than under natural conditions.

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/B/division/7/division/1/division/iv (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-7/division-1/division-iv
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.