# 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 2.4.5

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

Competent authorities shall evaluate the degree of adverse effects on the treated crop after use of the plant protection product in accordance with the proposed conditions of use in comparison, where relevant, with a suitable reference product or products, where they exist, and/or an untreated control.
(a)This evaluation shall take into consideration the following information:
(i)efficacy data;
(ii)other relevant information on the plant protection product such as nature of the plant protection product, dose, method of application, number and timing of applications, incompatibility with other crop treatments;
(iii)all relevant information on the micro-organism, including biological properties e.g. mode of action, survival, host specificity.
(b)This evaluation shall include:
(i)the nature, frequency, level and duration of observed phytotoxic/phytopathogenic effects and the agricultural, plant health and environmental (including climatic) conditions that affect them;
(ii)differences between main cultivars with regard to their sensitivity to phytotoxic/phytopathogenic effects;
(iii)the part of the treated crop or plant products where phytotoxic/phytopathogenic effects are observed;
(iv)adverse impact on the yield of the treated crop or plant products in terms of quantity and/or quality;
(v)adverse impact on treated plants or plant products to be used for propagation, in terms of viability, germination, sprouting, rooting and establishment;
(vi)where micro-organisms are disseminated, the adverse impact on adjacent crops.

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Source: https://www.legislation.gov.uk/eur/2011/546/annex/part/II/division/B/division/2/division/2.4/division/2.4.5 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-546/annex/part-II/division-B/division-2/division-2.4/division-2.4.5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.