# 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 2.8.2

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

Where there is a possibility of aquatic organisms being exposed, no authorisation shall be granted if:
(a)the micro-organism is pathogenic to aquatic organisms;
(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 100 in case of acute toxicity (EC50) to daphnia and fish and 10 for long-term/chronic toxicity to algae (EC50), daphnia (NOEC) and fish (NOEC), unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on the viability of exposed species occurs — 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/2.8.2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-546/annex/part-II/division-C/division-2/division-2.8/division-2.8.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.