# 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Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division (iv): In particular, the information provided for the micro-organism, together with other relevant information, and that provided for one or more preparations containing it, shall be sufficient to:

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

decide whether, or not, the micro-organism can be approved,
specify appropriate conditions or restrictions to be associated with any approval,
permit an evaluation of short- and long-term risks for non-target species — populations, communities, and processes — as appropriate,
classify the micro-organism as to biological hazard,
specify the precautions necessary for the protection of non-target species, and
specify the pictograms (once introduced), signal words, and relevant hazard and precautionary statements for the protection of the environment, to be mentioned on packaging (containers).

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/B/division/8/division/1/division/iv (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-8/division-1/division-iv
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.