ANNEXUNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF PLANT PROTECTION PRODUCTS, AS PROVIDED FOR IN F1ARTICLE 29(6)(a) OF REGULATION (EC) No 1107/2009

Annotations:

PART IUniform principles for evaluation and authorisation of chemical plant protection products

B.EVALUATION

2.Specific principles

2.2.Absence of unacceptable effects on plants or plant products

2.2.1.

F3Competent 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.

  1. (a)

    This evaluation shall take into consideration the following information:

    1. (i)

      the efficacy data provided for in the Annex to Regulation (EU) No 545/2011;

    2. (ii)

      other relevant information on the plant protection product such as nature of the preparation, dose, method of application, number and timing of applications;

    3. (iii)

      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.

  2. (b)

    This evaluation shall include:

    1. (i)

      the nature, frequency, level and duration of observed phytotoxic effects and the agricultural, plant health and environmental (including climatic) conditions that affect them;

    2. (ii)

      the differences between main cultivars with regard to their sensitivity to phytotoxic effects;

    3. (iii)

      the part of the treated crop or plant products where phytotoxic effects are observed;

    4. (iv)

      the adverse impact on the yield of the treated crop or plant products in terms of quantity and/or quality;

    5. (v)

      the adverse impact on treated plants or plant products to be used for propagation, in terms of viability, germination, sprouting, rooting and establishment;

    6. (vi)

      where volatile products are concerned, the adverse impact on adjacent crops.

2.2.2.

Where the available data indicate that the active substance or significant metabolites, degradation and reaction products persist in soils and/or in or on plant substances in significant quantities after use of the plant protection product in accordance with the proposed conditions of use, F2competent authorities shall evaluate the degree of adverse effects on subsequent crops. This evaluation shall be carried out as specified in point 2.2.1.

2.2.3.

Where the product label includes requirements for use of the plant protection product with other plant protection products or with adjuvants as a tank mix, the evaluation as specified in point 2.1.1 shall be carried out in relation to the information supplied for the tank mix.