# 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Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division (ii): For all micro-organisms that are subject to application all available relevant knowledge and information in literature should be provided.

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

The most important and informative information is obtained by the characterisation and identification of a micro-organism. Such information is found in Sections 1 to 3 (identity, biological properties and further information) which form the basis for an assessment of human health and environmental effects.
Newly generated data from conventional toxicological and/or pathological experiments on laboratory animals are normally required unless the applicant can justify, on the basis of the previous information, that the use of the micro-organism, under the proposed conditions of use, does not have any harmful effects on human and animal health or on groundwater or any unacceptable influence on the environment.

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