F1ANNEX VI
F1PART IIUNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF PLANT PROTECTION PRODUCTS CONTAINING MICRO-ORGANISMS
F1B.EVALUATION
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F11.General principles
F11.1.Having regard to current scientific and technical knowledge, Member States shall evaluate the information provided in accordance with the requirements of Annex IIB and IIIB and in particular:
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F11.2.The quality/methodology of tests, where there are no standardised test methods, must be evaluated and the following characteristics, when available, of the methods described must be assessed:
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F11.3.In interpreting the results of evaluations, Member States shall take into consideration possible elements of uncertainty in the information obtained during the evaluation, in order to ensure that the chances of failing to detect adverse effects or of underestimating their importance are reduced to a minimum. The decision-making process shall be examined to identify critical decision points or items of data for which uncertainties could lead to a false classification of risk.
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F11.4.
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F11.5.
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F11.6.
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F11.7.Where specific principles in Section 2 provide for the use of calculation models in the evaluation of a plant protection product, those models shall:
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F11.8.
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F12.Specific principles
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F12.1.Identity
F12.1.1.Identity of the micro-organism in the plant protection product
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F12.1.2.Identity of the plant protection product
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F12.2.Biological, physical, chemical, and technical properties
F12.2.1.Biological properties of the micro-organism in the plant protection product
F12.2.1.1.
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F12.2.1.2.The ability of micro-organisms to adapt to the environment must be evaluated. In particular, Member States must take account of the following principles:
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F12.2.1.3.The mode of action of the micro-organism should be evaluated in as much detail as appropriate. The possible role of metabolites/toxins for the mode of action should be evaluated and when identified, the minimal effective concentration for each active metabolite/toxin should be established. Information on mode of action can be a very valuable tool in identifying potential risks. Aspects to be considered in the evaluation, are:
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F12.2.1.4.In order to evaluate possible effects on non-target organisms, information on the micro-organism's host specificity must be evaluated, taking into account the characteristics and properties described in (a) and (b).
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F12.2.1.5.
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F12.2.2.Physical, chemical and technical properties of the plant protection product
F12.2.2.1.
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F12.2.2.2.
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F12.2.2.3.Member States shall evaluate the physical and chemical properties of the plant protection product and the retention of these characteristics after storage and take into consideration:
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F12.2.2.4.
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F12.3.Further information
F12.3.1.Quality control of the production of the micro-organism in the plant protection product
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F12.3.2.Quality control of the plant protection product
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F12.4.Efficacy
F12.4.1.
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F12.4.2.
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F12.4.3.Member States shall evaluate the efficacy data provided for in Annex IIIB on the plant protection product having regard to the degree of control or the extent of the effect desired and having regard to relevant experimental conditions such as:
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F12.4.4.Member States shall evaluate the performance of the plant protection product under the range of agricultural, plant health and environmental (including climatic) conditions likely to be encountered in practice in the area of proposed use. The effect on integrated control must be included in the evaluation. In particular, consideration should be paid to:
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F12.4.5.Member States shall evaluate the degree of adverse effects on the treated crop after use of the plant protection product according to the proposed conditions of use in comparison, where relevant, with a suitable reference product or products, where they exist, and/or an untreated control.
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F12.4.6.Where the plant protection product label includes requirements for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix, Member States shall make the evaluations referred to in points 2.4.3 to 2.4.5 in relation to the information supplied for the tank mix.
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F12.4.7.
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F12.4.8.Where the proposed use of a plant protection product is intended to have an effect on vertebrates, Member States shall evaluate the mechanism by which this effect is obtained and the observed effects on the behaviour and health of the target animals. When the intended effect is to kill the target animal they shall evaluate the time necessary to obtain the death of the animal and the conditions under which death occurs.
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F12.5.Identification/detection and quantification methods
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F12.5.1.Analytical methods for the plant protection product
F12.5.1.1.Non-viable components
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F12.5.1.2.Viable components
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F12.5.2.Analytical methods for the determination of residues
F12.5.2.1.Non-viable residues
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F12.5.2.2.Viable residues
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F12.6.Impact on human or animal health
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F12.6.1.Effects on human or animal health arising from the plant protection product
F12.6.1.1.Member States shall evaluate operator exposure to the micro-organism, and/or to toxicologically relevant compounds in the plant protection product (e.g. their metabolites/toxins, residual growth medium, contaminants and co-formulants), likely to occur under the proposed conditions of use (including in particular dose, application method and climatic conditions). Realistic data on exposure levels must be used and, if such data are not available, a suitable, validated calculation model. When available, a European harmonised generic exposure database for plant protection products should be used.
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F12.6.1.2.Member States shall examine information relating to the nature and characteristics of the packaging proposed with particular reference to the following aspects:
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F12.6.1.3.Member States shall examine the nature and characteristics of the protective clothing and equipment proposed with particular reference to the following aspects:
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F12.6.1.4.Member States shall evaluate the possibility of exposure of other humans (workers exposed after the application of the plant protection product, such as re-entering workers, or bystanders) or animals to the micro-organism and/or to other toxicologically relevant compounds in the plant protection product under the proposed conditions of use. This evaluation will take into consideration the following information:
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F12.6.2.Effects on human or animal health arising from residues
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F12.6.2.1.Non-viable residues
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F12.6.2.2.Viable residues
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F12.7.Fate and behaviour in the environment
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F12.7.1.Member States shall evaluate the possibility of contamination of ground water, surface water and drinking water under the proposed conditions of use of the plant protection product.
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F12.7.2.Member States shall evaluate the risk for the aquatic compartment where the possibility of the exposure of aquatic organisms has been established. A micro-organism may give rise to risks because of its potential through multiplication to establish itself in the environment and can therefore have a long-lasting or permanent impact on microbial communities or their predators.
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F12.7.3.
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F12.7.4.Member States shall evaluate the possibility of exposure of organisms in the terrestrial compartment to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the risks arising for the terrestrial compartment. A micro-organism may give rise to risks because of its potential through multiplication to establish itself in the environment and can therefore have a long-lasting or permanent impact on microbial communities or their predators.
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F12.8.Effects on and exposure of non-target organisms
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F12.8.1.Member States shall evaluate the possibility of exposure of and effects on terrestrial wildlife (non-domestic birds, mammals and other terrestrial vertebrates).
F12.8.1.1.A micro-organism may give rise to risks because of its potential to infect and multiply in avian and mammalian host systems. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:
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F12.8.1.2.A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects, the following information should be taken into consideration:
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F12.8.2.Member States shall evaluate the possibility of exposure of and effects on aquatic organisms.
F12.8.2.1.A micro-organism may give rise to risks because of its potential to infect and multiply in aquatic organisms. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:
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F12.8.2.2.A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration:
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F12.8.3.Member States shall evaluate the possibility of exposure of and effects on bees.
F12.8.3.1.A micro-organism may give rise to risks because of its potential to infect and multiply in bees. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:
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F12.8.3.2.A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration:
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F12.8.4.Member States shall evaluate the possibility of exposure of and effects on arthropods other than bees.
F12.8.4.1.A micro-organism may give rise to risks because of its potential to infect and multiply in arthropods other than bees. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:
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F12.8.4.2.A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration:
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F12.8.5.Member States shall evaluate the possibility of exposure of and effects on earthworms.
F12.8.5.1.A micro-organism may give rise to risks because of its potential to infect and multiply in earthworms. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:
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F12.8.5.2.A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration:
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F12.8.6.Member States shall evaluate the possibility of exposure of and effects on soil micro-organisms.
F12.8.6.1.A micro-organism may give rise to risks because of its potential to interfere with nitrogen and carbon mineralisation in the soil. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:
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F12.8.6.2.
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F12.8.6.3.A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration:
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F12.9.Conclusions and proposals
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Repealed by Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC.