# Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (Text with EEA relevance), Division 2.8.1

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

Where there is a possibility of birds and other non-target terrestrial vertebrates being exposed, no authorisation shall be granted if:
(a)the micro-organism is pathogenic to birds and other non-target terrestrial vertebrates;
(b)in case of toxic effects due to components in the plant protection product, such as relevant metabolites/toxins, the toxicity/exposure ratio is less than 10 on the basis of the acute LD50 value or the long-term toxicity/exposure ratio is less than 5, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable effects occur — directly or indirectly — after use of the plant protection product in accordance with the proposed conditions of use.

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Source: https://www.legislation.gov.uk/eur/2011/546/annex/part/II/division/C/division/2/division/2.8/division/2.8.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-546/annex/part-II/division-C/division-2/division-2.8/division-2.8.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.