# 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Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division (iv): Where testing is done, a detailed description (specification) of the material used and its impurities, in accordance with point 1.4, must be provided. The material used shall be of that specification that will be used in the manufacture of preparations to be authorised.

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

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

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/B/division/n1/division/iv (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-n1/division-iv
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.