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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)
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This evaluation shall take into consideration the following information:
the efficacy data provided for in the Annex to Regulation (EU) No 545/2011;
other relevant information on the plant protection product such as nature of the preparation, dose, method of application, number and timing of applications;
all relevant information on the active substance as provided for in of the Annex to Regulation (EU) No 544/2011, including mode of action, vapour pressure, volatility and water solubility.
This evaluation shall include:
the nature, frequency, level and duration of observed phytotoxic effects and the agricultural, plant health and environmental (including climatic) conditions that affect them;
the differences between main cultivars with regard to their sensitivity to phytotoxic effects;
the part of the treated crop or plant products where phytotoxic effects are observed;
the adverse impact on the yield of the treated crop or plant products in terms of quantity and/or quality;
the adverse impact on treated plants or plant products to be used for propagation, in terms of viability, germination, sprouting, rooting and establishment;
where volatile products are concerned, the adverse impact on adjacent crops.
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