# 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Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division (iv): In certain specified instances, tests must be conducted using purified active substance of stated specification. In such cases the principles of the method(s) of purification must be reported. The purity of such test material, which must be as high as can be achieved using the best available technology, must be reported. A reasoned justification must be provided in cases where the degree of purity achieved is less than 980 g/kg.

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

Such justification must demonstrate that all technically feasible and reasonable possibilities for the production of the pure active substance have been exhausted.

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/A/division/2/division/iv (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-iv
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.