1.1. The objective of the principles developed in this Annex is to ensure a high level of protection of human and animal (species normally fed and kept by humans or food-producing animals) health and the environment in evaluations and decisions by Member States with regard to authorisation of plant protection products, implementing the requirements of Article 29(1)(e) in conjunction with Article 4(3) and Article 29(1)(f), (g) and (h) of Regulation (EC) No 1107/2009. For the purpose of this Annex, the following definitions apply:

1.2. In evaluating applications for granting authorisations Member States shall:

1.3. Where, in the specific principles on evaluation, reference is made to the data of the Annex to Regulation (EU) No 283/2013 this shall be understood as being the data referred to in point 1.2(b) of this Annex.

1.4. Where the data and information provided are sufficient to permit completion of the evaluation for one of the proposed uses, Member States shall evaluate applications and make a decision for the proposed use.

1.5. During the process of evaluation and decision-making, Member States 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 technically complete dossier that allows for a proper evaluation, 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 compliance with the requirements of this Annex and more generally with the provisions of Regulation (EC) No 1107/2009.

1.6. During the process of evaluation and decision-making, Member States shall base their assessment on scientific principles, preferably recognised at international level, and this process shall be made with the benefit of expert advice.

1.7. Member States shall take into account those guidance documents applicable at the date of the submission of the application for the authorisation.

2.1. Having regard to current scientific and technical knowledge, Member States shall evaluate the information referred to in point 1.2, and in particular:

2.2. Member States shall evaluate the quality and the methodology of tests, especially where there are no standardised test methods, as well as the following characteristics of the methods described, when available:

2.3. In interpreting the results of evaluations, Member States shall take into consideration and report 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.

2.4. In accordance with Article 29 of Regulation (EC) No 1107/2009, Member States shall ensure that evaluations carried out have regard to the proposed practical conditions of use and, in particular, to the purpose of use, the application dose, the application method, frequency and timing of applications, and the nature and composition of the plant protection product.

2.5. In the evaluation, Member States shall consider the agricultural, plant health or environmental (including climatic) conditions in the areas of use.

2.6. Where specific principles in Section 1 of Part A or Section 1 of Part B (as applicable) provide for the use of calculation models in the evaluation of a plant protection product, those models shall:

2.7. Where metabolites are referred to in the specific principles, only those that are relevant for the proposed criterion shall be taken into consideration. For Part A this concerns also degradation or reaction products. For Part B this concerns what is defined as ‘metabolites of concern’.

3.1. Where appropriate, Member States shall impose conditions or restrictions on the authorisations they grant. The nature and severity of these conditions or restrictions shall be selected on the basis of, and be appropriate to, the nature and extent of the expected advantages and the risks likely to arise.

3.2. Member States shall ensure that decisions taken to grant authorisations take account of the agricultural, plant health or environmental (including climatic) conditions in the areas of envisaged use. Such considerations may result in specific conditions and restrictions on use, and in authorisation being granted for some but not other areas within the Member State in question.

3.3. Member States shall ensure that the authorised application rates and number of applications, are the minimum necessary to achieve the desired effect even where higher rates would not result in unacceptable risks to human or animal health or to the environment. The authorised rates shall be differentiated in accordance with, and be appropriate to, the agricultural, plant health or environmental (including climatic) conditions in the various areas for which an authorisation is granted. However, the application rates and the number of applications may not give rise to undesirable effects such as the development of resistance in the target organism.

3.4. Member States shall ensure that decisions taken to grant authorisations consider integrated pest management as set out in Directive 2009/128/EC. In particular, Member States shall ensure that a warning phrase is indicated on the label in case negative effects are expected on beneficial organisms that are deliberately released as part of integrated pest management strategies.

3.5. Since the evaluation is to be based on data concerning a limited number of representative non-target species, Member States shall ensure that use of plant protection products does not have any long-term repercussions for the abundance and diversity of non-target species.

3.6. Before issuing an authorisation, Member States shall ensure that the label of the plant protection product:

3.7. Before issuing authorisations, Member States shall:

3.8. No authorisation shall be granted unless all the requirements referred to in Section 2 of Part A or Section 2 of Part B (as applicable) are satisfied. However:

3.9. Where an authorisation has been granted in accordance with the requirements provided for in this Annex, Member States may, by virtue of Article 44 of Regulation (EC) No 1107/2009:

3.10. Member States shall ensure, as far as it is practically possible, that for all active substances contained in plant protection products that are considered for an authorisation, the applicant has taken into account all available relevant knowledge and information in scientific literature at the time of submission of the dossier on the plant protection product.

1.1.1. Where the proposed use concerns the control of or protection against an organism, Member States shall evaluate the possibility that this organism could be harmful under the agricultural, plant health and environmental (including climatic) conditions in the area of the proposed use.

1.1.2. Where the proposed use concerns an effect other than the control of or protection against an organism, Member States shall evaluate whether significant damage, loss or inconvenience could occur under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use if the plant protection product were not used.

1.1.3. Member States shall evaluate the efficacy data on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013 having regard to the degree of control or the extent of the effect desired and having regard to the relevant experimental conditions such as:

1.1.4. Member States shall evaluate the performance of the plant protection product in a range of agricultural, plant health and environmental (including climatic) conditions likely to be encountered in practice in the area of proposed use and in particular:

1.1.5. Where the 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 1.1.1 to 1.1.4 in relation to the information supplied for the tank mix.

1.2.1. Member States 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.

1.2.2. 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, Member States shall evaluate the degree of adverse effects on subsequent crops. This evaluation shall be carried out as specified in point 1.2.1.

1.2.3. 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 1.1.1 shall be carried out in relation to the information supplied for the tank mix.

1.4.1. Impact on human or animal health arising from the plant protection product

1.4.1.1. Member States shall evaluate operator exposure to the active substance and/or to toxicologically relevant compounds in the plant protection product likely to occur under the proposed conditions of use (including in particular dose, application method and climatic conditions) using by preference realistic data on exposure and, if such data are not available, a suitable, validated calculation model.

1.4.1.2. Member States shall examine information relating to the nature and characteristics of the packaging proposed with particular reference to the following aspects:

1.4.1.3. Member States shall examine the nature and characteristics of the protective clothing and equipment proposed with particular reference to the following aspects:

1.4.1.4. Member States shall evaluate the possibility of exposure of other humans (bystanders or workers exposed after the application of the plant protection product) or animals to the active substance and/or to other toxicologically relevant compounds in the plant protection product under the proposed conditions of use.

1.4.2. Impact on human and animal health arising from residues

1.4.2.1. Member States shall evaluate the specific information on toxicology as provided for in the Annex to Regulation (EU) No 283/2013 and in particular:

1.4.2.2. Prior to evaluating the residue levels in the reported trials or in products of animal origin Member States shall examine the following information:

1.4.2.3. On the basis of suitable statistical models Member States shall evaluate the residue levels observed in the reported trials. This evaluation shall be made for each proposed use and shall take into consideration:

1.4.2.4. Member States shall evaluate the residue levels observed in products of animal origin, taking into consideration the information provided for in Section 8 of Part A of the Annex to Regulation (EU) No 284/2013 and residues resulting from other uses.

1.4.2.5. Member States shall estimate the potential exposure of consumers through diet and, where relevant, other ways of exposure, using a suitable calculation model. This evaluation shall take account, where relevant, of other sources of information such as other authorised uses of plant protection products containing the same active substance or which give rise to the same residues.

1.4.2.6. Member States shall, where relevant, estimate the exposure of animals, taking into account the residue levels observed in treated plants or plant products intended to be fed to animals.

1.5.1. Fate and distribution in the environment

1.5.1.1. Member States shall evaluate the possibility of the plant protection product reaching the soil under the proposed conditions of use; if this possibility exists they shall estimate the rate and the route of degradation in the soil, the mobility in the soil and the change in the total concentration (extractable and non-extractable ( 5 )) of the active substance and of relevant metabolites, degradation and reaction products that could be expected in the soil in the area of envisaged use after use of the plant protection product in accordance with the proposed conditions of use.

1.5.1.2. Member States shall evaluate the possibility of the plant protection product reaching the groundwater under the proposed conditions of use; if this possibility exists, they shall estimate, using a suitable calculation model validated at EU level, the concentration of the active substance and of relevant metabolites, degradation and reaction products that could be expected in the groundwater in the area of envisaged use after use of the plant protection product in accordance with the proposed conditions of use.

1.5.1.3. Member States shall evaluate the possibility of the plant protection product reaching surface water under the proposed conditions of use; if this possibility exists they shall estimate, using a suitable calculation model validated at EU level, the short-term and long-term predicted concentration of the active substance and of metabolites, degradation and reaction products that could be expected in the surface water in the area of envisaged use after use of the plant protection product in accordance with the proposed conditions of use.

1.5.1.4. Member States shall evaluate the possibility of the plant protection product being dissipated in the air under the proposed conditions of use; if this possibility exists they shall make the best possible estimation, using where appropriate a suitable, validated calculation model, of the concentration of the active substance and of relevant metabolites, degradation and reaction products that could be expected in the air after use of the plant protection product in accordance with the proposed conditions of use.

1.5.1.5. Member States shall evaluate the procedures for destruction or decontamination of the plant protection product and its packaging.

1.5.2. Impact on non-target species

1.5.2.1. Member States shall evaluate the possibility of exposure of birds and other terrestrial vertebrates to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the extent of the short-term and long-term risk to be expected for these organisms, including their reproduction, after use of the plant protection product in accordance with the proposed conditions of use.

1.5.2.2. Member States shall evaluate the possibility of exposure of aquatic organisms to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the degree of short-term and long-term risk to be expected for aquatic organisms after use of the plant protection product in accordance with the proposed conditions of use.

1.5.2.3. Member States shall evaluate the possibility of exposure of honeybees to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the short-term and long-term risk to be expected for honeybees after use of the plant protection product in accordance with the proposed conditions of use.

1.5.2.4. Member States shall evaluate the possibility of exposure of beneficial arthropods other than honeybees to the plant protection product under the proposed conditions of use; if this possibility exists they shall assess the lethal and sublethal effects on these organisms to be expected and the reduction in their activity after use of the plant protection product in accordance with the proposed conditions of use.

1.5.2.5. Member States shall evaluate the possibility of exposure of earthworms and other non-target soil macro-organisms to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the degree of short-term and long-term risk to be expected to these organisms after use of the plant protection product in accordance with the proposed conditions of use.

1.5.2.6. Member States shall, where the evaluation carried out under point 1.5.1.1 does not exclude the possibility of the plant protection product reaching the soil under the proposed conditions of use, evaluate the impact on microbial activity such as the impact on nitrogen and carbon mineralisation processes in the soil after use of the plant protection product in accordance with the proposed conditions of use.

1.6.1. for formulation analysis:

1.6.2. for residue analysis:

1.7.1. Member States shall evaluate the actual active substance content of the plant protection product and its stability during storage.

1.7.2. Member States shall evaluate the physical and chemical properties of the plant protection product and in particular:

1.7.3. Where proposed label claims include requirements or recommendations for use of the plant protection product with other plant protection products or adjuvants as a tank mix, the physical and chemical compatibility of the products in the mixture must be evaluated.

2.1.1. Where the proposed uses include recommendations for the control of or protection against organisms which are not considered to be harmful on the basis of experience acquired or scientific evidence under normal agricultural, plant health and environmental (including climatic) conditions in the areas of proposed use or where the other intended effects are not considered to be beneficial under those conditions, no authorisation shall be granted for those uses.

2.1.2. The level, consistency and duration of control or protection or other intended effects must be similar to those resulting from the use of suitable reference products. If no suitable reference product exists, the plant protection product must be shown to give a defined benefit in terms of the level, consistency and duration of control or protection or other intended effects under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use.

2.1.3. Where relevant, yield response when the product is used and reduction of loss in storage must be quantitatively and/or qualitatively similar to those resulting from the use of suitable reference products. If no suitable reference product exists, the plant protection product must be shown to give a consistent and defined quantitative and/or qualitative benefit in terms of yield response and reduction of loss in storage under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use.

2.1.4. Conclusions as to the performance of the preparation must be valid for all areas of the Member State in which it is to be authorised, and must hold for all conditions under which its use is proposed, except where the proposed label specifies that the preparation is intended for use in certain specified circumstances (e.g. light infestations, particular soil types or particular growing conditions).

2.1.5. 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 2.1.1 to 2.1.4.

2.2.1. There must be no relevant phytotoxic effects on treated plants or plant products except where the proposed label indicates appropriate limitations of use.

2.2.2. There must be no reduction of yield at harvest due to phytotoxic effects below that which could be obtained without the use of the plant protection product, unless this reduction is compensated for by other advantages such as an enhancement of the quality of the treated plants or plant products.

2.2.3. There must be no unacceptable adverse effects on the quality of treated plants or plant products, except in the case of adverse effects on processing where proposed label claims specify that the preparation must not be applied to crops to be used for processing purposes.

2.2.4. There must be no unacceptable adverse effects on treated plants or plant products used for propagation or reproduction, such as effects on viability, germination, sprouting, rooting and establishment, except where proposed label claims specify that the preparation should not be applied to plants or plant products to be used for propagation or reproduction.

2.2.5. There must be no unacceptable impact on succeeding crops, except where proposed label claims specify that particular crops, which would be affected, must not be grown following the treated crop.

2.2.6. There must be no unacceptable impact on adjacent crops, except where proposed label claims specify that the preparation should not be applied when particular sensitive adjacent crops are present.

2.2.7. Where proposed label claims include requirements for use of the preparation with other plant protection products or adjuvants, as a tank mix, the mixture must comply with the principles referred to in points 2.2.1 to 2.2.6.

2.2.8. The proposed instructions for cleaning the application equipment must be both practical and effective so that they can be applied with ease to ensure the removal of residual traces of the plant protection product which could subsequently cause damage.

2.4.1. Impact on human or animal health arising from the plant protection product

2.4.1.1. No authorisation shall be granted if the extent of operator exposure in handling and using the plant protection product under the proposed conditions of use, including dose and application method, exceeds the AOEL.

2.4.1.2. Where the proposed conditions of use require use of items of protective clothing and equipment, no authorisation shall be granted unless those items are effective and in accordance with the relevant EU provisions and are readily obtainable by the user and unless it is feasible to use them under the circumstances of use of the plant protection product, taking into account climatic conditions in particular.

2.4.1.3. Plant protection products which because of particular properties or if mishandled or misused could lead to a high degree of risk must be subject to particular restrictions such as restrictions on the size of packaging, formulation type, distribution, use or manner of use.

2.4.1.4. Waiting and re-entry safety periods or other precautions must be such that the exposure of bystanders or workers exposed after the application of the plant protection product does not exceed the AOEL levels established for the active substance or toxicologically relevant compound(s) in the plant protection product nor any limit values established for those compounds in accordance with the EU provisions referred to in point 2.4.1.1.

2.4.1.5. Waiting and re-entry safety periods or other precautions must be established in such a way that no adverse impact on animals occurs.

2.4.1.6. Waiting and re-entry periods or other precautions to ensure that the AOEL levels and limit values are respected must be realistic; if necessary special precautionary measures must be prescribed.

2.4.2. Impact on human or animal health arising from residues

2.4.2.1. Authorisations must ensure that residues occurring reflect the minimum quantities of the plant protection product necessary to achieve adequate control corresponding to good agricultural practice, applied in such a manner (including pre-harvest intervals or withholding periods or storage periods) that the residues at harvest, slaughter or after storage, as appropriate, are reduced to a minimum.

2.4.2.2. Where the new circumstances under which the plant protection product is to be used do not correspond to those under which a MRL (maximum residue limit) was established previously, Member States shall not grant an authorisation for the plant protection product unless the applicant can provide evidence that its recommended use shall not exceed the MRL established under Regulation (EC) No 396/2005 of the European Parliament and of the Council ( 8 ).

2.4.2.3. Where a MRL exists Member States shall not grant an authorisation for the plant protection product unless the applicant can provide evidence that its recommended use shall not exceed that MRL, or unless a new MRL has been established under Regulation (EC) No 396/2005.

2.4.2.4. In the cases referred to in points 2.4.2.2, each application for an authorisation must be accompanied by a risk assessment taking into account worst-case potential exposure of consumers in the Member State concerned on the basis of good agricultural practice.

2.4.2.5. Where the nature of residues is affected during processing, a separate risk assessment may need to be carried out under the conditions provided for in point 2.4.2.4.

2.4.2.6. Where the treated plants or plant products are intended to be fed to animals, residues occurring shall not have an adverse effect on animal health.

2.5.1. Fate and distribution in the environment

2.5.1.1. No authorisation shall be granted if the active substance and, where they are of significance from the toxicological, ecotoxicological or environmental point of view, metabolites and breakdown or reaction products, after use of the plant protection product under the proposed conditions of use:

2.5.1.2. No authorisation shall be granted if the concentration of the active substance or of relevant metabolites, degradation or reaction products in groundwater, may be expected to exceed, as a result of use of the plant protection product under the proposed conditions of use, the lower of the following limit values:

2.5.1.3. No authorisation shall be granted if the concentration of the active substance or of relevant metabolites, breakdown or reaction products to be expected after use of the plant protection product under the proposed conditions of use in surface water:

2.5.1.4. No authorisation shall be granted if the airborne concentration of the active substance under the proposed conditions of use is such that either the AOEL or the limit values for operators, bystanders or workers as referred to in point 2.4.1 are exceeded.

2.5.2. Impact on non-target species

2.5.2.1. Where there is a possibility of birds and other non-target terrestrial vertebrates being exposed, no authorisation shall be granted if:

2.5.2.2. Where there is a possibility of aquatic organisms being exposed, no authorisation shall be granted if:

2.5.2.3. Where there is a possibility of honeybees being exposed, no authorisation shall be granted if the hazard quotients for oral or contact exposure of honeybees are greater than 50, unless it is clearly established through an appropriate risk assessment that under field conditions there are no unacceptable effects on honeybee larvae, honeybee behaviour, or colony survival and development after use of the plant protection product in accordance with the proposed conditions of use.

2.5.2.4. Where there is a possibility of beneficial arthropods other than honeybees being exposed, no authorisation shall be granted if more than 30 % of the test organisms are affected in lethal or sublethal laboratory tests conducted at the maximum proposed application rate, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on those organisms after use of the plant protection product in accordance with the proposed conditions of use. Any claims for selectivity and proposals for use in integrated pest management systems shall be substantiated by appropriate data.

2.5.2.5. Where there is a possibility of earthworms being exposed, no authorisation shall be granted if the acute toxicity/exposure ratio for earthworms is less than 10 or the long-term toxicity/exposure ratio is less than 5, unless it is clearly established through an appropriate risk assessment that under field conditions earthworm populations are not at risk after use of the plant protection product in accordance with the proposed conditions of use.

2.5.2.6. Where there is a possibility of non-target soil micro-organisms being exposed, no authorisation shall be granted if the nitrogen or carbon mineralisation processes in laboratory studies are affected by more than 25 % after 100 days, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on microbial activity after use of the plant protection product in accordance with the proposed conditions of use, taking account of the ability of micro-organisms to multiply.

2.6.1. for formulation analysis:

2.6.2. for residue analysis:

2.7.1 Where an appropriate FAO specification exists, that specification must be met.

2.7.2. Where no appropriate FAO specification exists, the physical and chemical properties of the product must meet the following requirements

2.7.3. Where the proposed label claims include requirements or recommendations for use of the preparation with other plant protection products or adjuvants as a tank mix and/or where the proposed label includes indications on the compatibility of the preparation with other plant protection products as a tank mix, those products or adjuvants must be physically and chemically compatible in the tank mix.

1.1.1. Identity of the micro-organism contained in the plant protection product

1.1.2. Quality control of the production of the micro-organism contained in the plant protection product

1.1.3. Identity of the plant protection product

1.1.4. Quality control of the plant protection product

1.2.1. Biological properties of the micro-organism in the plant protection product

1.2.1.1. Member States shall evaluate information on the origin, occurrence and history of use of the micro-organism contained the plant protection product, giving particular relevance to both the location from which the strain was isolated, and the geographical distribution of the micro-organism at the relevant highest taxonomic level in relevant European environments.

1.2.1.2. Member States shall evaluate information on the ecology and the life cycle of the micro-organism, taking also into consideration the population densities of the micro-organism in relation to host densities as provided for in point 2.3 of Part B of the Annex to Regulation (EU) No 283/2013. In particular, for bacteriophages, the lysogenic and lytic properties of the virus shall be evaluated.

1.2.1.3. Member States shall evaluate information on the mode of action on the target organisms for the plant protection product to identify potential risks and function of the active substance that is a micro-organism according to the proposed conditions of use. In particular, Member States shall evaluate the role of possible infectivity, pathogenicity, toxicity and relevant antimicrobial activity in the mode of action against the target organism. If applicable, factors that enhance the pathogenicity/virulence of a micro-organism and environmental factors affecting a pathogenic mode of action shall be described.

1.2.1.4. Member States shall evaluate data provided on the host range of the micro-organism, taking into account any available information on the relationship of the micro-organism to known pathogens to humans, animals, plants and other non-target species, at the most appropriate taxonomic level.

1.2.1.5. Member States shall evaluate information on growth requirements, by defining limiting factors e.g. UV light, humidity, pH, temperatures and other relevant agro-environmental conditions influencing the growth of the micro-organism.

1.2.1.6. Member States shall evaluate the genetic stability of a micro-organism that is a non-virulent variant of a plant pathogen virus, taking into consideration the likelihood of the micro-organisms to regain virulence, and the risk that could be caused by this occurrence.

1.2.1.7. In order to determine whether the micro-organism produces metabolites of concern, Member States shall take into account the information on production, toxicity and exposure concerning metabolites as provided for in points 2.8, 6.1, 6.2, 5.5, 7.2 and 8.8 of Part B of the Annex to Regulation (EU) No 283/2013.

1.2.1.8. For bacteria, Member States shall evaluate information on phenotypical resistance to relevant antimicrobial agents. Member States shall evaluate, taking into consideration that resistance genes in bacteria can be horizontally transmitted, and that this may potentially interfere with the effectiveness of relevant antimicrobial agents, information on the presence and transferability of genes coding for resistance to such antimicrobial agents.

1.2.2. Physical, chemical and technical properties of the plant protection product

1.2.2.1. Member States shall evaluate shelf-life and storage stability of the plant protection product, taking into account the packaging, optimal (recommended) storage temperature, and light conditions. Possible changes in composition due to growth or decline of the micro-organism or of relevant contaminating micro-organisms, or the production of metabolites of concern during storage, etc., shall be considered.

1.2.2.2. 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, unless a suitable FAO specification exists, all relevant physical and chemical properties of the plant protection product.

1.2.2.3. Where the proposed label includes requirements or recommendations for use of the plant protection product in combination with other plant protection products or adjuvants as a tank mix, Member states shall evaluate whether the plant protection product is physically and chemically compatible with those other plant protection products or adjuvants in the tank mix.

1.3.1. Where the proposed use concerns the control of or protection against an organism, Member States shall evaluate if the target organism could be a danger to plant health under the agricultural and environmental (including climatic) conditions in the area of the proposed use.

1.3.2. Member States shall evaluate whether significant damage to plants or plant products or loss in yields could occur under the agricultural and environmental (including climatic) conditions in the area of proposed use, if the plant protection product was not used.

1.3.3. Member States shall evaluate the efficacy data provided for in Part B of the Annex to Regulation (EU) No 284/2013 for the plant protection product, having regard to the degree of control or the extent of the effect desired and to relevant experimental conditions such as:

1.3.4. Member States shall evaluate the efficacy 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 evaluation shall include the compatibility with integrated pest management. In particular, consideration shall be paid to:

1.3.5. Member States shall evaluate possible occurrence of adverse effects and their degree, 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.

1.3.6. Where the proposed label of the plant protection product includes recommendations or requirements for the use of the plant protection product with other plant protection products and/or adjuvants as a tank mix, Member States shall make the evaluations referred to in points 1.3.3 to 1.3.5 with regard to the information supplied for the tank mix, and shall evaluate the appropriateness of the mix and of its conditions of use.

1.3.7. Member States shall evaluate potential effects (e.g. antagonism, fungicidal effects) on the activity of the micro-organism after mixing or spraying in sequence (or employing other relevant types of applications) with other plant protection products in accordance with the instructions proposed by the applicant on the label.

1.3.8. Where the available data indicate that the micro-organism has adverse effects on plants, or that metabolites of concern that have adverse effects on plants can persist in soil, and/or persist in/on plants in significant quantities after use of the plant protection product in accordance with the proposed conditions of use, Member States shall evaluate the degree of adverse effects on succeeding crops, taking into consideration the relevant information provided for under point 6.6 of Part B of the Annex to Regulation (EU) No 284/2013.

1.3.9. Member States shall evaluate potential negative effects of the micro-organism on beneficial organisms, either deliberately released, or as part of other practices (e.g. conservation biological control), taking into consideration the relevant information provided for under point 6.7 of Part B of the Annex to Regulation (EU) No 284/2013.

1.3.10. 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.

1.3.11. If there is evidence of development of resistance of the target organism towards the plant protection product requiring a resistance management strategy, the Member State shall evaluate if the submitted resistance management strategy, required according to point 6.4 of Part B of the Annex to Regulation (EU) No 284/2013, addresses this adequately and sufficiently.

1.4.1. Analytical methods for the plant protection product

1.4.1.1. Analytical methods for micro-organisms

1.4.1.2. Analytical methods for metabolites of concern, relevant impurities, additives, co-formulants, safeners and synergist

1.4.2. Analytical methods for the determination of residues and density of the micro-organism

1.4.2.1. Density of the micro-organism

1.4.2.2. Residues of metabolites of concern

1.5.1. Effects on human or animal health arising from the plant protection product

1.5.1.1. Availability of sufficient treatment options against the micro-organism contained in the plant protection product shall be evaluated.

1.5.1.2. Member States shall evaluate infectivity and pathogenicity of the micro-organism and toxicity of metabolites of concern and relevant impurities. This evaluation shall take into consideration the following information:

1.5.1.3. Member States shall evaluate the effects to human and animal health related to non-dietary exposure of operators, workers, bystanders and residents to the micro-organism which is contained in the plant protection product, and the components which may be toxicologically relevant (e.g. metabolites of concern, relevant impurities), and which are likely to occur under the proposed conditions of use (including, in particular, dose, application method and climatic conditions). Realistic data on exposure levels to the plant protection product shall be used. If such data is not available, a suitable, and if possible validated, calculation model for plant protection products containing a micro-organism shall be employed. This evaluation shall take into consideration the following aspects:

1.5.1.4. Member States shall evaluate information relating to the nature and characteristics of the packaging proposed, in particular the following aspects:

1.5.1.5. Member States shall evaluate the nature and characteristics of the protective clothing and equipment proposed, in particular the following aspects:

1.5.1.6. Micro-organisms approved as active substances of plant protection product are not expected to be infective for humans. However, in order to ensure the availability of sufficient therapeutic measures in the event of opportunistic infections, Member States shall, where relevant based on biological properties of the micro-organism, evaluate the susceptibility of the micro-organism (except viruses) to antimicrobial agents.

1.5.2. Effects on human or animal health arising from residues of metabolites of concern

1.5.2.1. Member States shall evaluate the potential residue levels of metabolites of concern for which a hazard was identified to human or animal health in points 2.8 and 5.5 of Part B of Annex to Regulation (EU) No 283/2013. This evaluation shall be performed for each proposed use and shall take into account the following information:

1.5.2.2. Member States shall, where relevant, estimate the exposure of animals to residues of metabolites of concern, taking into account the residue levels estimated or measured in treated plants or plant products intended to be fed to animals.

1.5.2.3. Member States shall, where relevant, evaluate the residues of metabolites of concern estimated or measured in products of animal origin and their toxicity, taking into consideration the information provided for under points 2.8 and 5.5 and Section 6 of Part B of the Annex to Regulation (EU) No 283/2013.

1.5.2.4. Member States shall, where relevant, estimate the potential exposure of consumers to metabolites of concern through diet via the products of animal origin mentioned in point 1.5.2.3, using a suitable calculation model. This evaluation shall take account, where relevant, of other sources of the same metabolite of concern for which either maximum residue levels had been set in accordance with Regulation (EC) No 396/2005 (in case of authorised uses of the micro-organism producing it in biocidal or veterinary products), or maximum tolerances have been set in accordance with Regulation (EEC) No 315/93, where relevant.

1.5.2.5. Member States shall assess data on density of micro-organisms on edible parts of treated crops, if those are provided to support the estimation of residues of metabolites of concern produced in-situ. Data on density of micro-organisms on edible parts of treated crops is required only in few circumstances, as provided for in point 6.1 of Part B of Annex to Regulation (EU) No 283/2013, since micro-organisms which are infective or pathogenic to humans or other vertebrate animals will not be eligible for approval, and non-pathogenic micro-organisms are not expected to cause adverse effects to consumers, apart from possible production of metabolites of concern to be assessed in accordance with the points 1.5.2.1 to 1.5.2.4. Absence of viable micro-organisms on edible parts excludes the risk of in-situ production of metabolites of concern.

1.6.1. Environmental occurrence of the micro-organism

1.6.2. Environmental fate and behaviour of the metabolites of concern

1.7.1. Member States shall evaluate the risks to terrestrial vertebrates after the use of the plant protection product in accordance with the proposed conditions of use and taking into account the evaluation criteria provided for in point 1.6.

1.7.2. Member States shall evaluate the risks to aquatic organisms after the use of the plant protection product in accordance with the proposed conditions of use and taking into account the evaluation criteria provided for in point 1.6.

1.7.3. Member States shall evaluate the risks to bees after the use of the plant protection product in accordance with the proposed conditions of use and taking into account the evaluation criteria provided for in point 1.6.

1.7.4. Member States shall evaluate the risks to non-target arthropods other than bees after the use of the plant protection product in accordance with the proposed conditions of use and taking into account the evaluation criteria provided for in point 1.6. Member States shall pay particular attention to the risks to beneficial organisms deliberately released for biocontrol purposes.

1.7.5. Member States shall evaluate the risks to non-target meso- and macro-organisms in soil after the use of the plant protection product in accordance with the proposed conditions of use and taking into account the evaluation criteria provided for in point 1.6.

1.7.6. Member States shall evaluate the risks to non-target terrestrial plants after the use of the plant protection product in accordance with the proposed conditions of use and taking into account the evaluation criteria provided for in point 1.6.

2.1.1. For each authorisation granted the Member States shall ensure that the active substance concerned has been approved in accordance with Regulation (EC) No 1107/2009.

2.1.2. For each authorisation granted the Member States shall set the specification as regards the composition of the plant protection product. The minimum and maximum content of the micro-organism that is the active substance contained in the plant protection product shall be defined. The content of metabolites of concern, relevant impurities, co-formulants, safeners and synergists in the plant protection product, and relevant contaminating micro-organisms derived from the production process shall to the extent possible be defined. Member States shall verify, based on the information provided in the dossier, that quality assurance on the manufacturing process allows levels of metabolites of concern, relevant impurities, and relevant contaminating micro-organisms to be controlled to an acceptable level.

2.1.3. No authorisation shall be granted unless the manufacturing processes of the MPCA as manufactured and the plant protection product ensure that the production of MPCA as manufactured and plant protection product is of consistent quality, as set out in the specification set out in point 2.1.2.

2.1.4. In accordance with Article 48 of Regulation (EC) No 1107/2009 and Directive 2001/18/EC of the European Parliament and of the Council ( 15 ), where the micro-organism has been genetically modified no authorisation shall be granted unless:

2.1.5. Member States shall ensure that adequate quality control measures are applied to ensure the identity of the micro-organism and of the other components of the plant protection product.

2.2.1. No authorisation shall be granted for a plant protection product containing a micro-organism, if the micro-organism that is the active substance is a non-virulent variant of a plant pathogen virus, and the likelihood of regaining virulence and causing adverse effects in target and non-target plants through mutation, after application under the proposed conditions of use (including possible risk mitigation measures), is not negligible.

2.3.1. Efficacy

2.3.1.1. No authorisation shall be granted where, on the basis of experience acquired or scientific evidence under normal agricultural, plant health and environmental (including climatic) conditions, the proposed uses include:

2.3.1.2. No authorisation shall be granted when the proposed minimum dose, or a range of minimum doses, necessary to achieve sufficient efficacy against a target pest or any other relevant benefit across the proposed use, i.e. the minimum effective dose, is not justified based on available information or efficacy trials.

2.3.1.3. The level, consistency and duration of control or protection or other intended effects shall be at least higher than those observed in the untreated control, and if possible similar to a suitable reference product. Where relevant, yield response when the plant protection product is used, or reduction of loss in storage, shall be quantitatively and/or qualitatively at least higher than those observed for the untreated control, and if possible similar to a suitable reference product. The plant protection product shall be shown to give a defined benefit under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use.

2.3.1.4. Conclusions as to the efficacy of the plant protection product shall be valid for all areas and conditions in which it is to be authorised.

2.3.1.5. Where the proposed label includes recommendations or requirements for use of the plant protection product with other specified plant protection products and/or adjuvants in a tank mix, spray sequences, or employing other relevant types of applications, or any other recommendations (e.g. weather conditions, soil conditions, irrigation application), Member States shall not accept the recommendations or requirements unless they are justified, if applicable, by supporting information and comply with the principles referred to in points 2.3.1.1 to 2.3.1.4.

2.3.1.6. Where negative interactions are expected between the plant protection product containing the micro-organism(s) and other plant protection products, which the label requires to use in tank mix, spray sequences, or employing other relevant types of applications, or other common practices (e.g. conservation biological control), affecting the efficacy of one or the others, Member States shall set appropriate conditions in the authorisation of the plant protection product containing the micro-organism(s), and they shall ensure that a warning labelling phrase is indicating such negative interaction.

2.3.2. Absence of unacceptable effects on plants and plant products

2.3.2.1. There shall be no relevant phytotoxic or pathogenic effects on treated plants or plant products, except where the proposed label indicates appropriate limitations of use.

2.3.2.2. There shall be no reduction of yield at harvest below that which could be obtained without the use of the plant protection product, unless this reduction is compensated for by other advantages beside the plant protection action, such as an enhancement of the quality of the treated plants or plant products.

2.3.2.3. There shall be no unacceptable adverse effects on the quality of treated plants or plant products, except in the case of adverse effects on food and feed transformation processes (e.g. wine making, brewing, bread making, or silage productions as feed) where proposed label specifies that the plant protection product shall not be applied to crops to be used in transformation processes.

2.3.2.4. There shall be no unacceptable adverse effects on treated plants or plant products used for propagation or reproduction, such as effects on viability, germination, sprouting, rooting and establishment, except where proposed label specifies that the plant protection product shall not be applied to plants or plant products to be used for propagation or reproduction.

2.3.2.5. There shall be no unacceptable impact on succeeding crops, except where proposed label specifies that particular crops, which would be affected, shall not be grown following the treated crop.

2.3.2.6. There shall be no unacceptable impact on adjacent crops, except where proposed label specifies that the plant protection product should not be applied when particular sensitive adjacent crops are present.

2.3.2.7. Where the proposed label of the plant protection product includes recommendations or requirements for the use with other plant protection products and/or adjuvants as a tank mix, the same criteria referred to in points 2.3.2.1 to 2.3.2.6 apply in relation to the information supplied for the tank mix.

2.3.2.8. The proposed instructions for cleaning the application equipment shall be both practical and effective so that they can be applied with ease so as to ensure the removal of residual traces of the plant protection product which could subsequently cause damage.

2.4.1. No authorisation shall be granted unless there is an adequate method of sufficient quality to identify and quantify the micro-organism in appropriate microbial unit, and any other components of the plant protection product, such as metabolites of concern, relevant impurities and co-formulants, which are relevant for human and animal health and/or the environment. For a plant protection product containing more than one micro-organism as active substance, the recommended methods should be capable of identifying and determining the content of each micro-organism independently of the others.

2.4.2. No authorisation shall be granted unless there is an adequate method for control and monitoring to identify and quantify residues of metabolites of concern for which MRL have been set. These methods shall involve the use of commonly available reagents and equipment. Methods shall be available for analysis of:

2.5.1. Effects on human and animal health arising from the plant protection product

2.5.1.1. No authorisation shall be granted if it is concluded that the micro-organism is infective or causes unacceptable adverse health effects in humans or animals under the recommended conditions of use, including in a realistic worst case exposure scenario.

2.5.1.2. No authorisation shall be granted if, where relevant based on biological properties of the micro-organism, there are no sufficient treatment options which are effective against the micro-organism.

2.5.1.3. No authorisation shall be granted if the plant protection product has unacceptable toxic effects on humans or animals under the proposed conditions of use, including in a realistic worst-case exposure scenario.

2.5.1.4. All micro-organisms shall be regarded as potential sensitisers until a test method is validated and unless it is established by means of relevant information that there is no risk of sensitisation. Authorisations granted shall therefore specify, as a non-specific risk mitigation measure, that personal protective equipment (e.g. masks) shall be worn, taking into account the conditions of use, and that the exposure via inhalation to the plant protection product containing a micro-organism shall be minimised. In addition, the proposed conditions of use may require that specific risk mitigation measures are applied as envisaged by Article 6 of Regulation (EC) No 1107/2009.

2.5.1.5. Plant protection products which, because of particular properties, or which, if mishandled or misused, could lead to unacceptable risk, shall be subject to particular restrictions such as restrictions on the size of packaging, preparation type, distribution, use or manner of use. In addition, plant protection products, which are classified as very toxic, shall not be authorised for use by non-professional users.

2.5.1.6. Waiting and re-entry safety periods or other precautions shall be established in such a way that no infection of or other adverse effects on bystanders, workers, or residents or animals exposed after application of the plant protection product are expected.

2.5.1.7. Waiting and re-entry periods or other precautions to ensure that no infection or adverse effects are expected shall be realistic; if necessary, special precautionary measures shall be prescribed.

2.5.1.8. The conditions of authorisation shall be in compliance with Council Directives 98/24/EC ( 17 ) and 89/656/EEC ( 18 ), and Directives 2000/54/EC ( 19 ) and 2004/37/EC of the European Parliament and of the Council. The experimental data and information relevant to the recognition of the symptoms of infection and on the effectiveness of first aid and therapeutic measures provided shall be considered.

2.5.2. Effects on human and animal health arising from residues

2.5.2.1. No authorisation shall be granted unless there is sufficient information for plant protection products containing an active substance that is a micro-organism, to decide that there is no harmful effect on human or animal health arising from exposure to the micro-organism and metabolites of concern remaining in or on plants or plant products.

2.5.2.2. No authorisation shall be granted where the treated plants or plant products are intended to be fed to animals and residues occurring have adverse effect on animal health.

2.6.1. No authorisation shall be granted if, as a result of the use of the plant protection product under the proposed conditions, a contamination of surface water is expected by metabolites of concern, and:

2.6.2 No authorisation shall be granted unless the proposed instruction for use of the plant protection product, including procedures for cleaning application equipment, are clearly described, and reduce to the minimum the likelihood of accidental contamination of surface water.

2.6.3. No authorisation shall be granted if, as a result of the use of the plant protection product under the proposed conditions, contamination of groundwater is expected by metabolites of concern, and this contamination exceeds the lower of the following limit values:

2.7.1. Where there is a possibility of terrestrial vertebrates being exposed according to the consideration done under point 1.6, no authorisation shall be granted:

2.7.2. Where there is a possibility of aquatic organisms being exposed according to the consideration done under point 1.6, no authorisation shall be granted:

2.7.3. Where the possibility of bees to be exposed cannot be excluded according to the consideration done under point 1.6, no authorisation shall be granted:

2.7.4. Where there is a possibility of arthropods other than bees being exposed according to the consideration done under point 1.6, no authorisation shall be granted:

2.7.5. Where the micro-organism was not isolated from the soil and there is a possibility of meso- and macro-organisms in soil being exposed according to the consideration done under point 1.6, no authorisation shall be granted:

2.7.6. If the micro-organism has an herbicidal mode of action or it is closely related to a known plant pathogen, and there is a possibility of terrestrial plants being exposed to the micro-organism according to the consideration done under point 1.6, no authorisation shall be granted if the micro-organism is pathogenic to, or the plant protection product has toxic effects on, terrestrial plants. This criterion applies unless it is clearly established through an appropriate risk assessment that, under field conditions, no unacceptable impact on non-target terrestrial plant populations occurs after use of the plant protection product in accordance with the proposed conditions of use.