# Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance), Division 5.8.1: Toxicity studies of metabolites

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 shall be made on a case by case basis.
Where as a result of metabolism or other processes, metabolites from plants or in animal products, soil, groundwater, open air differ from those in animals used for the toxicology studies or are detected in low proportions in animals, further testing shall be carried out on a case by case basis, taking into account the amount of metabolite and the chemical structure of the metabolite compared to the parent.

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Source: https://www.legislation.gov.uk/eur/2013/283/annex/section/5/division/5.8/division/5.8.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-283/annex/section-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.