# 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: Effects on and exposure of non-target organisms

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

Information on the ecology of the micro-organism and effects on the environment shall be assessed as well as possible exposure levels and the effects of its relevant metabolites/toxins. An overall assessment of the environmental risks that the plant protection product may cause, taking into account the normal levels of exposure to micro-organisms both in the environment as well as in the body of organisms, is necessary.
Competent authorities shall evaluate the possibility of exposure of non-target organisms under the proposed conditions of use and if this possibility exists they shall evaluate the risks arising for the non-target organisms concerned.
Where applicable, an assessment of infectivity and pathogenicity is necessary, unless it can be justified that non-target organisms shall not be exposed.
To assess the possibility of exposure the following information shall also be taken into consideration:
(a)the survival of the micro-organism in the respective compartment;
(b)its ecological niche;
(c)the natural background level of the micro-organism, where it is indigenous;
(d)information on fate and behaviour in the various parts of the environment;
(e)where relevant, other authorised uses of the plant protection product in the area of envisaged use containing the same active substance or which give rise to the same residues.

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