# 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Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division (iii): A detailed description (specification) of the material used, as provided for under point 1.11 must be provided. Where testing is done using active substance the material used shall be of that specification that will be used in the manufacture of preparations to be authorised except where radio-labelled material is used.

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

Where studies are conducted using active substance produced in the laboratory or in a pilot plant production system, the studies must be repeated using active substance as manufactured, unless it can be justified that the test material used is essentially the same for the purposes of environmental testing and assessment.

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