F1ANNEX VI
F1PART IIUNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF PLANT PROTECTION PRODUCTS CONTAINING MICRO-ORGANISMS
F1A.INTRODUCTION
F11.
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F12.In evaluating applications for granting authorisations Member States shall:
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F13.
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F14.Where the data and information provided are sufficient to permit completion of the evaluation for one of the proposed uses, applications must be evaluated and a decision made for the proposed use.
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F15.During the process of evaluation and decision-making, the Member State shall cooperate with the applicants in order to resolve any questions on the dossier quickly or to identify at an early stage any additional studies necessary for a proper evaluation of the dossier, or to amend any proposed conditions for the use of the plant protection product or to modify its nature or its composition in order to ensure full satisfaction of the requirements of this Annex or of this Directive.
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F16.
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F17.
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F18.
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F19.
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F110.Definitions and explanations of microbiological terms
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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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F1C.DECISION-MAKING
F11.General principles
F11.1.
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F11.2.
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F11.3.
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F11.4.
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F11.5.
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F11.6.Before issuing an authorisation, Member States shall ensure that the label of the plant protection product:
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F11.7.Before issuing authorisations, Member States shall:
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F11.8.No authorisation shall be granted unless all the requirements referred to in point 2 are satisfied. However, when one or more of the specific decision-making requirements referred to in point 2.4 are not fully satisfied, authorisations shall be granted only where the advantages of the use of the plant protection product under the proposed conditions of use outweigh the possible adverse effects of its use. Any restrictions on use of the plant protection product relating to non-compliance with some of the requirements referred to in point 2.4 must be mentioned on the label. These advantages can be in terms of:
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F11.9.Where an authorisation has been granted according to the requirements provided for in this Annex, Member States may, by virtue of Article 4(6):
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F11.10.
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F11.11.
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F11.12.
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F11.13.
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F11.14.
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F12.Specific principles
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F12.1.Identity
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F12.2.Biological and technical properties
F12.2.1.
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F12.2.2.
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F12.3.Further information
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F12.4.Efficacy
F12.4.1.Performance
F12.4.1.1.
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F12.4.1.2.
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F12.4.1.3.
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F12.4.1.4.
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F12.4.1.5.Where proposed label claims include requirements for use of the preparation with other specified plant protection products or adjuvants as a tank mix, the mixture must achieve the desired effect and comply with the principles referred to in points 2.4.1.1 to 2.4.1.4.
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F12.4.1.6.
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F12.4.1.7.
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F12.4.2.Absence of unacceptable effects on plants and plant products
F12.4.2.1.
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F12.4.2.2.
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F12.4.2.3.
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F12.4.2.4.
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F12.4.2.5.
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F12.4.2.6.
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F12.4.2.7.
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F12.4.2.8.
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F12.5.Identification/detection and quantification methods
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F12.5.1.
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F12.5.2.No authorisation shall be granted unless there are adequate methods for post-registration control and monitoring of viable and/or non-viable residues. Methods must be available for analysis of:
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F12.6.Impact on human and animal health
F12.6.1.Effects on human and animal health arising from the plant protection product
F12.6.1.1.
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F12.6.1.2.No authorisation shall be granted if the micro-organism and/or the plant protection product containing the micro-organism might, under the recommended conditions of use, including a realistic worst case scenario, colonise or cause adverse effects in humans or animals.
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F12.6.1.3.All micro-organisms should be regarded as potential sensitisers, unless it is established by means of relevant information that there is no risk of sensitisation, taking into account immuno-compromised and other sensitive individuals. Authorisations granted shall therefore specify that protective clothing and suitable gloves be worn and that the plant protection product containing the micro-organism should not be inhaled. Moreover, the proposed conditions of use may require use of additional items of protective clothing and equipment.
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F12.6.1.4.
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F12.6.1.5.
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F12.6.1.6.
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F12.6.1.7.
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F12.6.1.8.
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F12.6.1.9.
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F12.6.2.Effects on human and animal health arising from residues
F12.6.2.1.
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F12.6.2.2.
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F12.7.Fate and behaviour in the environment
F12.7.1.
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F12.7.2.
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F12.7.3.No authorisation shall be granted if the contamination of groundwater expected as a result of the use of a plant protection product under the proposed conditions of use contravenes or exceeds whichever of the following is the lower:
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F12.7.4.No authorisation shall be granted if the contamination of surface water expected as a result of the use of a plant protection product under the proposed conditions of use:
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F12.7.5.
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F12.7.6.
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F12.7.7.
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F12.8.Effects on non-target organisms
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F12.8.1.Where there is a possibility of birds and other non-target terrestrial vertebrates being exposed, no authorisation shall be granted if:
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F12.8.2.Where there is a possibility of aquatic organisms being exposed, no authorisation shall be granted if:
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F12.8.3.Where there is a possibility of bees being exposed, no authorisation shall be granted:
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F12.8.4.Where there is a possibility of arthropods other than bees being exposed, no authorisation shall be granted if:
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F12.8.5.
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F12.8.6.
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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.