Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products Text with EEA relevance
Modified by
- Commission Regulation (EU) 2018/676of 3 May 2018correcting Commission Regulation (EU) No 546/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products(Text with EEA relevance), 32018R0676, May 4, 2018
- Commission Regulation (EU) 2022/1441of 31 August 2022amending Regulation (EU) No 546/2011 as regards specific uniform principles for evaluation and authorisation of plant protection products containing micro-organisms(Text with EEA relevance)Corrigendum to Commission Regulation (EU) 2022/1441 of 31 August 2022 amending Regulation (EU) No 546/2011 as regards specific uniform principles for evaluation and authorisation of plant protection products containing micro-organisms(Official Journal of the European Union L 227 of 1 September 2022), 32022R144132022R1441R(01), September 1, 2022
Corrected by
- Corrigendum to Commission Regulation (EU) 2022/1441 of 31 August 2022 amending Regulation (EU) No 546/2011 as regards specific uniform principles for evaluation and authorisation of plant protection products containing micro-organisms, 32022R1441R(01), November 24, 2022
(1) "efficacy" means a measure concerning the overall effect of the application of a plant protection product on the agricultural system in which it is used (i.e. which includes positive effects of treatment in performing the desired plant protection activity and negative effects such as development of resistance, phytotoxicity or reduction of qualitative or quantitative yield);(2) "relevant impurity" means a chemical impurity that is of concern for human health, animal health or the environment;(3) "storage stability" means the capacity of a plant protection product to maintain the initial properties and the specified content during the storage period under established storage conditions.
(a) ensure that dossiers supplied are in accordance with the requirements of the Annex to Commission Regulation (EU) No 284/2013 Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 93, 3.4.2013, p. 85 ).ensure that the data submitted by the applicant are acceptable in terms of quantity, quality, consistency and reliability and sufficient to permit a proper evaluation of the dossier, evaluate, where relevant, justifications submitted by the applicant for not supplying certain data;
(b) take into account the data concerning the active substance in the plant protection product of the Annex to Commission Regulation (EU) No 283/2013 Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 93, 3.4.2013, p. 1 ).(c) take into consideration other relevant technical or scientific information with regard to the efficacy of the plant protection product or to the potentially adverse effects of the plant protection product its components or its residues, where relevant.
(a) identify the risks arising, assess their significance and the expected exposure, and make a judgement as to the likely risks to humans, animals or the environment; (b) assess efficacy in terms of effectiveness (including possible development of resistance or cross-resistance of the target organism(s)) and adverse effects (including phytotoxicity/pathogenicity) on crops (including treated crops, succeeding crops and adjacent crops) of the plant protection product for each use for which authorisation is sought.
(a) make a best possible estimation in an appropriate way of all relevant processes involved taking into account realistic parameters and assumptions; (b) be submitted to an evaluation as referred to in point 2.3; (c) be reliably validated with measurements carried out under circumstances relevant for the use of the model; (d) be relevant to the conditions in the area of use; (e) in cases the models have not been validated, be supported with details indicating how the model calculates estimates provided, and explanations of all the inputs to the model and details of how they have been derived.
(a) fulfils the requirements setting out in Regulation (EU) No 547/2011; (b) also contains the information on protection of operators, workers, bystanders and residents required by EU legislation on worker protection; (c) specifies in particular the conditions or restrictions under which the plant protection product may or may not be used as referred to in points 3.1 to 3.5 of this general introduction.
(a) ensure that the proposed packaging is in accordance with the provisions of Regulation (EC) No 1272/2008; (b) ensure that the following procedures are in accordance with the relevant regulatory provisions: the procedures for destruction of the plant protection product, the procedures for neutralisation of any adverse effects of the plant protection product if it is accidentally dispersed, and the procedures for the decontamination and destruction of the packaging.
(a) when one or more of the specific decision-making requirements referred to in points 2.1, 2.2, 2.3 or 2.7 of Part A, or point 2.3 of Part B, respectively, are not 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 aforementioned requirements must be mentioned on the label, and non-compliance with the requirements referred to in point 2.7 of Part A (if Part A applies) shall not compromise proper use of the plant protection product. These advantages can be in terms of: advantages for and compatibility with integrated control measures or organic farming, facilitating strategies to minimise the risk of development of resistance, the need for a greater diversity of types of active substances or biochemical modes of action, e.g. for use in strategies to avoid accelerated breakdown in the soil, reduced risk for operators and consumers, reduced contamination of the environment and reduced impact on non-target species.
(b) where the criteria referred to in point 2.6 of Part A or point 2.4 of Part B, respectively, are not fully satisfied because of limitations in current analytical science and technology, authorisation shall be granted for a limited period if the methods submitted prove adequate for the purposes intended. In this case, the applicant shall be required to develop and submit analytical methods that are in accordance with those criteria by a specific deadline. The authorisation shall be reviewed on expiry of that deadline; (c) where the reproducibility of the submitted analytical methods referred to in point 2.6 of Part A or point 2.4 of Part B, respectively has only been verified in two laboratories, an authorisation shall be granted for 1 year to permit the applicant to demonstrate the reproducibility of those methods in accordance with agreed criteria in at least a third laboratory.
(a) define, where possible, preferably in close cooperation with the applicant, measures to improve the efficacy of the plant protection product; and/or (b) define, where possible, in close cooperation with the applicant, measures to reduce further the exposure that could occur during and after use of the plant protection product.
the choice of the crop or cultivar, the agricultural and environmental (including climatic) conditions, the presence and density of the harmful organism, the development stage of crop and organism, the amount of the plant protection product used, if required on the label, the amount of adjuvant added, the frequency and timing of the applications, the type of application equipment.
(i) the level, consistency and duration of the effect sought in relation to the dose in comparison with a suitable reference product or products and an untreated control; (ii) where relevant, effect on yield or reduction of loss in storage, in terms of quantity and/or quality, in comparison with a suitable reference product or products and an untreated control.
(a) This evaluation shall take into consideration the following information: (i) the efficacy data provided for in the Annex to Regulation (EU) No 284/2013; (ii) other relevant information on the plant protection product such as nature of the preparation, dose, method of application, number and timing of applications; (iii) all relevant information on the active substance as provided for in of the Annex to Regulation (EU) No 283/2013, including mode of action, vapour pressure, volatility and water solubility.
(b) This evaluation shall include: (i) the nature, frequency, level and duration of observed phytotoxic effects and the agricultural, plant health and environmental (including climatic) conditions that affect them; (ii) the differences between main cultivars with regard to their sensitivity to phytotoxic effects; (iii) the part of the treated crop or plant products where phytotoxic effects are observed; (iv) the adverse impact on the yield of the treated crop or plant products in terms of quantity and/or quality; (v) the adverse impact on treated plants or plant products to be used for propagation, in terms of viability, germination, sprouting, rooting and establishment; (vi) where volatile products are concerned, the adverse impact on adjacent crops.
(i) all relevant information as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof, including the toxicological and metabolism studies; (ii) all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013, including toxicological studies and efficacy data.
(a) This evaluation shall take into consideration the following information: (i) the toxicological and metabolism studies as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof including the acceptable operator exposure level (AOEL). The acceptable operator exposure level is the maximum amount of active substance to which the operator may be exposed without any adverse health effects. The AOEL is expressed as milligrams of the chemical per kilogram body weight of the operator. The AOEL is based on the highest level at which no adverse effect is observed in tests in the most sensitive relevant animal species or, if appropriate data are available, in humans; (ii) other relevant information on the active substances such as physical and chemical properties; (iii) the toxicological studies provided for in the Annex to Regulation (EU) No 284/2013, including where appropriate dermal absorption studies; (iv) other relevant information as provided for in the Annex to Regulation (EU) No 284/2013 such as: composition of the preparation, nature of the preparation, size, design and type of packaging, field of use and nature of crop or target, method of application including handling, loading and mixing of product, exposure reduction measures recommended, protective clothing recommendations, maximum application rate, minimum spray application volume stated on the label, number and timing of applications.
(b) This evaluation shall be made for each type of application method and application equipment proposed for use of the plant protection product as well as for the different types and sizes of containers to be used, taking account of mixing, loading operations, application of the plant protection product and cleaning and routine maintenance of application equipment.
the type of packaging, its dimensions and capacity, the size of the opening, the type of closure, its strength, leakproofness and resistance to normal transport and handling, its resistance to and compatibility with the contents.
obtainability and suitability, ease of wearing taking into account physical stress and climatic conditions.
(i) the toxicological and metabolism studies on the active substance as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof, including the acceptable operator exposure level; (ii) the toxicological studies provided for in the Annex to Regulation (EU) No 284/2013, including where appropriate dermal absorption studies; (iii) other relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013 such as: re-entry periods, necessary waiting periods or other precautions to protect humans and animals, method of application, in particular spraying, maximum application rate, maximum spray application volume, composition of the preparation, excess remaining on plants and plant products after treatment, further activities whereby workers are exposed.
the determination of an acceptable daily intake (ADI), the identification of metabolites, degradation and reaction products in treated plants or plant products, behaviour of residues of the active substance and its metabolites from the time of application until harvest, or in the case of postharvest uses, until outloading of stored plant products.
data on the proposed good agricultural practice, including data on application as provided for in the Annex to Regulation (EU) No 284/2013 and proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses, nature of the preparation, analytical methods and the residue definition.
(i) the proposed conditions of use of the plant protection product; (ii) the specific information on residues in or on treated plants, plant products, food and feed as provided for in the Annex to Regulation (EU) No 284/2013 and the distribution of residues between edible and non-edible parts; (iii) the specific information on residues in or on treated plants, plant products, food and feed as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (iv) the realistic possibilities of extrapolating data from one crop to another.
(i) the specific information on fate and behaviour in soil as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: molecular weight, solubility in water, octanol/water partition coefficient, vapour pressure, volatilisation rate, dissociation constant, photodegradation rate and identity of breakdown products, hydrolysis rate in relation to pH and identity of breakdown products.
(iii) all information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013, including the information on distribution and dissipation in soil; (iv) where relevant, other authorised uses of plant protection products in the area of proposed use containing the same active substance or which give rise to the same residues.
(i) the specific information on fate and behaviour in soil and water as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: molecular weight, solubility in water, octanol/water partition coefficient, vapour pressure, volatilisation rate, hydrolysis rate in relation to pH and identity of breakdown products, dissociation constant;
(iii) all information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013, including the information on distribution and dissipation in soil and water; (iv) where relevant, other authorised uses of plant protection products in the area of envisaged use containing the same active substance or which give rise to the same residues; (v) where relevant, data on dissipation including transformation and sorption in the saturated zone; (vi) where relevant, data on the procedures for drinking water abstraction and treatment in the area of envisaged use; (vii) where relevant, monitoring data on the presence or absence of the active substance and relevant metabolites, degradation or reaction products in groundwater as a result of previous use of plant protection products containing the same active substance or which give rise to the same residues; such monitoring data shall be interpreted in a consistent scientific way.
(i) the specific information on fate and behaviour in soil and water as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: molecular weight, solubility in water, octanol/water partition coefficient, vapour pressure, volatilisation rate, hydrolysis rate in relation to pH and identity of breakdown products, dissociation constant;
(iii) all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013, including the information on distribution and dissipation in soil and water; (iv) possible routes of exposure: drift, run-off, overspray, discharge via drains, leaching, deposit from the atmosphere;
(v) where relevant, other authorised uses of plant protection products in the area of envisaged use containing the same active substance or which give rise to the same residues; (vi) where relevant, data on the procedures for drinking water abstraction and treatment in the area of envisaged use.
(i) the specific information on fate and behaviour in soil, water and air as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: vapour pressure, solubility in water, hydrolysis rate in relation to pH and identity of breakdown products, photochemical degradation in water and air and identity of breakdown products, octanol/water partition coefficient;
(iii) all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013, including the information on distribution and dissipation in air.
(a) This evaluation shall take into consideration the following information: (i) the specific information relating to toxicological studies on mammals and to the effects on birds and other non-target terrestrial vertebrates, including effects on reproduction, and other relevant information concerning the active substance as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013, including the information on effects on birds and other non-target terrestrial vertebrates; (iii) where relevant, other authorised uses of plant protection products in the area of envisaged use containing the same active substance or which give rise to the same residues.
(b) This evaluation shall include: (i) the fate and distribution, including persistence and bioconcentration, of the active substance and of relevant metabolites, breakdown and reaction products in the various parts of the environment after application of the plant protection product; (ii) the estimated exposure of the species likely to be exposed at the time of application or during the period that residues are present, taking into account all relevant routes of exposure such as ingestion of the formulated product or treated food, predation on invertebrates, feeding on vertebrate prey, contact by overspraying or with treated vegetation; (iii) a calculation of the acute, short-term and, where necessary, long-term toxicity/exposure ratio. The toxicity/exposure ratios are defined as respectively the quotient of LD 50 , LC50 or non-observable effects of concentration (NOEC) expressed on an active substance basis and the estimated exposure expressed in mg/kg body weight.
(a) This evaluation shall take into consideration the following information: (i) the specific information relating to the effects on aquatic organisms as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: solubility in water, octanol/water partition coefficient, vapour pressure, volatilisation rate, KOC, biodegradation in aquatic systems and in particular the ready biodegradability, photodegradation rate and identity of breakdown products, hydrolysis rate in relation to pH and identity of breakdown products.
(iii) all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013 and in particular the effects on aquatic organisms; (iv) where relevant, other authorised uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues.
(b) This evaluation shall include: (i) the fate and distribution of residues of the active substance and of relevant metabolites, breakdown and reaction products in water, sediment or fish; (ii) a calculation of the acute toxicity/exposure ratio for fish and Daphnia. This ratio is defined as the quotient of respectively acute LC 50 or EC50 and the predicted short-term environmental concentration;(iii) a calculation of the algal growth inhibition/exposure ratio for algae. This ratio is defined as the quotient of the EC 50 and the predicted short-term environmental concentration;(iv) a calculation of the long-term toxicity/exposure ratio for fish and Daphnia. The long-term toxicity/exposure ratio is defined as the quotient of the NOEC and the predicted long-term environmental concentration; (v) where relevant, the bioconcentration in fish and possible exposure of predators of fish, including humans; (vi) if the plant protection product is to be applied directly to surface water, the effect on the change of surface water quality, such as pH or dissolved oxygen content.
(a) This evaluation shall take into consideration the following information: (i) the specific information on toxicity to honeybees as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: solubility in water, octanol/water partition coefficient, vapour pressure, photodegradation rate and identity of breakdown products, mode of action (e. g. insect growth regulating activity);
(iii) all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013, including the toxicity to honeybees; (iv) where relevant, other authorised uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues.
(b) This evaluation shall include: (i) the ratio between the maximum application rate expressed in grams of active substance per hectare and the contact and oral LD 50 expressed in μg of active substance per bee (hazard quotients) and where necessary the persistence of residues on or, where relevant, in the treated plants;(ii) where relevant, the effects on honeybee larvae, honeybee behaviour, colony survival and development after use of the plant protection product in accordance with the proposed conditions of use.
(i) the specific information on toxicity to honeybees and other beneficial arthropods as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: solubility in water, octanol/water partition coefficient, vapour pressure, photodegradation rate and identity of breakdown products, mode of action (e. g. insect growth regulating activity);
(iii) all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013 such as: effects on beneficial arthropods other than bees, toxicity to honeybees, available data from biological primary screening, maximum application rate, maximum number and timetable of applications;
(iv) where relevant, other authorised uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues.
(a) This evaluation shall take into consideration the following information: (i) the specific information relating to the toxicity of the active substance to earthworms and to other non-target soil macro-organisms as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: solubility in water, octanol/water partition coefficient, Kd for adsorption, vapour pressure, hydrolysis rate in relation to pH and identity of breakdown products, photodegradation rate and identity of breakdown products, DT 50 and DT90 for degradation in the soil.
(iii) all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013, including the effects on earthworms and other non-target soil macro-organisms; (iv) where relevant, other authorised uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues.
(b) This evaluation shall include: (i) the lethal and sublethal effects; (ii) the predicted initial and long-term environmental concentration; (iii) a calculation of the acute toxicity/exposure ratio (defined as the quotient of LC 50 and predicted initial environmental concentration) and of the long-term toxicity/exposure ratio (defined as the quotient of the NOEC and predicted long-term environmental concentration);(iv) where relevant, the bioconcentration and persistence of residues in earthworms.
(i) all relevant information on the active substance, including the specific information relating to the effects of non-target soil micro-organisms as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013, including the effects on non-target soil micro-organisms; (iii) where relevant, other authorised uses of plant protection products in the area of proposed use, containing the same active substance or which give rise to the same residues; (iv) all available information from biological primary screening.
(i) the data on analytical methods as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) the data on analytical methods as provided for in the Annex to Regulation (EU) No 284/2013 and in particular: the specificity and linearity of the proposed methods, the importance of interferences, the precision of the proposed methods (intralaboratory repeatability and interlaboratory reproducibility);
(iii) the limit of detection and determination of the proposed methods for impurities.
(i) the data on analytical methods as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) the data on analytical methods as provided for in the Annex to Regulation (EU) No 284/2013 and in particular: the specificity of the proposed methods, the precision of the proposed methods (intralaboratory repeatability and interlaboratory reproducibility), the recovery rate of the proposed methods at appropriate concentrations;
(iii) the limit of detection of the proposed methods; (iv) the limit of determination of the proposed methods.
where a suitable FAO (Food and Agriculture Organisation of the United Nations) specification exists, the physical and chemical properties addressed in that specification, where no suitable FAO specification exists, all the relevant physical and chemical properties for the formulation as referred to in the "Manual on development and use of FAO and WHO specifications for pesticides".
(i) the data on the physical and chemical properties of the active substance as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) the data on the physical and chemical properties of the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013.
death is synchronous with the extinction of consciousness, or death occurs immediately, or vital functions are reduced gradually without signs of obvious suffering.
(i) acute toxicity category 1 and 2 for any route of uptake, provided the ATE (acute toxicity estimate) of the product does not exceed 25 mg/kg bw for the oral route of uptake or 0,25 mg/l/4h for the inhalation of dust, mist or fume; (ii) STOT (single exposure), category 1 (oral), provided their classification is due to the presence of classified substances showing significant non-lethal toxic effects at guidance values below 25 mg/kg bw; (iii) STOT (single exposure), category 1 (dermal), provided their classification is due to the presence of classified substances showing significant non-lethal toxic effects at guidance values below 50 mg/kg bw; (iv) STOT (single exposure), category 1 (inhalation of gas/vapour), provided their classification is due to the presence of classified substances showing significant non-lethal toxic effects at guidance values below 0,5 mg/l/4h; (v) STOT (single exposure), category 1 (inhalation of dust/mist/fume), provided their classification is due to the presence of classified substances showing significant non-lethal toxic effects at guidance values below 0,25 mg/l/4h.
during tests in the field, persist in soil for more than 1 year (i.e. DT 90 > 1 year and DT50 > 3 months), orduring laboratory tests, form non-extractable residues in amounts exceeding 70 % of the initial dose after 100 days with a mineralisation rate of less than 5 % in 100 days,
(i) the maximum permissible concentration laid down by Council Directive 98/83/EC Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, p. 32 ).(ii) the maximum concentration laid down when approving the active substance in accordance with Regulation (EC) No 1107/2009, on the basis of appropriate data, in particular toxicological data, or, where that concentration has not been laid down, the concentration corresponding to one tenth of the ADI laid down when the active substance was approved in accordance with Regulation (EC) No 1107/2009,
exceeds, where the surface water in or from the area of envisaged use is intended for the abstraction of drinking water, concentrations above which compliance with drinking water quality established in accordance with Directive 2000/60/EC of the European Parliament and of the Council Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1 ).has an impact deemed unacceptable on non-target species, including animals, in accordance with the relevant requirements provided for in point 2.5.2.
the acute and short-term toxicity/exposure ratio for birds and other non-target terrestrial vertebrates is less than 10 on the basis of LD 50 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 no unacceptable impact occurs after use of the plant protection product in accordance with the proposed conditions of use,the bioconcentration factor (BCF, related to fat tissue) is greater than 1, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable effects occur — directly or indirectly — after use of the plant protection product in accordance with the proposed conditions of use.
the toxicity/exposure ratio for fish and Daphnia is less than 100 for acute exposure and less than 10 for long-term exposure, or the algal growth inhibition/exposure ratio is less than 10, or the maximum bioconcentration factor (BCF) is greater than 1000 for plant protection products containing active substances which are readily biodegradable or greater than 100 for those which are not readily biodegradable,
(i) the method must be able to determine and confirm residues of toxicological, ecotoxicological or environmental significance; (ii) the mean recovery rates should be between 70 % and 110 % with a relative standard deviation of ≤ 20 %; (iii) the repeatability must be less than the following values for residues in foodstuffs: Residue level mg/kg Difference mg/kg Difference in % 0,01 0,005 50 0,1 0,025 25 1 0,125 12,5 > 1 12,5 Intermediate values shall be determined by interpolation from a log-log graph; (iv) the reproducibility must be less than the following values for residues in foodstuffs: Residue level mg/kg Difference mg/kg Difference in % 0,01 0,01 100 0,1 0,05 50 1 0,25 25 > 1 25 Intermediate values are determined by interpolation from a log-log graph; (v) in the case of residue analysis in treated plants, plant products, foodstuffs, feedingstuffs or products of animal origin, except where the MRL or the proposed MRL is at the limit of determination, the sensitivity of the methods proposed must satisfy the following criteria: Limit of determination in relation to the proposed provisional or EU MRL: MRL (mg/kg) limit of determination (mg/kg) > 0,5 0,1 0,5 –0,05 0,1 –0,02 < 0,05 MRL × 0,5
(a) Chemical properties: Throughout the shelf-life period, the difference between the stated and the actual content of the active substance in the plant protection product must not exceed the following values: Declared content in g/kg or g/l at 20 °C Tolerance up to 25 ± 15 % homogeneous formulation± 25 % non-homogeneous formulationmore than 25 up to 100 ± 10 %more than 100 up to 250 ± 6 %more than 250 up to 500 ± 5 %more than 500 ± 25 g/kg or ±25 g/l(b) Physical properties: The plant protection product must fulfil the physical criteria (including storage stability) specified for the relevant formulation type in the "Manual on the development and use of FAO and WHO specifications for plant protection products".
(1) "strain" means a genetic variant of an organism in its taxonomic level (species) that is made up of the descendants of a single isolation in pure culture from the original matrix (e.g. the environment) and usually is made up of a succession of cultures ultimately derived from an initial single colony;(2) "Microbial Pest Control Agent as manufactured" ("MPCA as manufactured") means the outcome of the manufacturing process of the micro-organism(s) intended to be used as active substance in plant protection products, consisting of the micro-organism(s) and any additives, metabolites (including metabolites of concern), chemical impurities (including relevant impurities), contaminating micro-organisms (including relevant contaminating micro-organisms) and the spent medium/rest fraction resulting from the manufacturing process or, in case of a continuous manufacturing processes where a strict separation between the manufacturing of the micro-organism(s) and the production process of the plant protection product is not possible, a non-isolated intermediate;(3) "relevant contaminating micro-organism" means a pathogenic/infective micro-organism unintentionally present in the MPCA as manufactured;(4) "spent medium/rest fraction" means the fraction of the MPCA as manufactured consisting of remaining or transformed starting materials, and excluding the micro-organism(s) that is the active substance, metabolites of concern, additives, relevant contaminating micro-organisms, and relevant impurities;(5) "starting material" means substances used in the manufacturing process of the MPCA as manufactured as substrate and/or buffering agent;(6) "ecological niche" means an ecological function and actual physical spaces occupied by a particular species within the community or ecosystem;(7) "host range" means the range of different biological host-species that can be infected by a microbial species or strain;(8) "infectivity" means the ability of a micro-organism to cause an infection;(9) "infection" means the non-opportunistic introduction or entry of a micro-organism into a susceptible host, where the micro-organism is able to reproduce to form new infective units and persist in the host, whether or not it causes pathological effects or disease;(10) "pathogenicity" means the non-opportunistic ability of a micro-organism to inflict injury and damage to the host upon infection;(11) "non-opportunistic" means a condition under which a micro-organism exerts an infection or inflicts injury or damage when the host is not weakened by a predisposing factor (e.g. immune system impaired by an unrelated cause);(12) "opportunistic infection" means an infection occurring in a host weakened by a predisposing factor (e.g. immune system impaired by an unrelated cause);(13) "virulence" means the degree of pathogenicity that a pathogenic micro-organism is able to exert in the host;(14) "metabolite of concern" means a metabolite produced by the micro-organism under assessment, with known toxicity or known relevant antimicrobial activity, which is present in the MPCA as manufactured at levels that may present a risk to human health, animal health or the environment, and/or for which it cannot be adequately justified thatin-situ production of the metabolite is not relevant for the risk assessment;(15) "background level of a metabolite" means a level of a metabolite that is likely to occur in relevant European environments (including also sources different than those of plant protection) and/or in food and feed (e.g. edible plant parts), when the micro-organisms are in conditions to grow, reproduce and to produce such metabolite in presence of a host or availability of carbon and nutrient sources, under consideration of high host densities and nutrients;(16) " means the production of a metabolite by the micro-organism after application of the plant protection product containing that micro-organism;in-situ production"(17) "antibiosis" means a relationship between two or more species in which one species is actively harmed (as by the production of toxins by the harming species);(18) "antimicrobial resistance" ("AMR") means the intrinsic or acquired ability of a micro-organism to multiply in the presence of an antimicrobial agent at concentrations which are relevant for therapeutic measures in human or veterinary medicine, making that substance therapeutically ineffective;(19) "antimicrobial agent" means any antibacterial, antiviral, antifungal, anthelmintic or antiprotozoal agent that is a substance of natural, semi-synthetic, or synthetic origin that atin vivo concentrations kills or inhibits the growth of micro-organisms by interacting with a specific target;(20) "acquired antimicrobial resistance" means a non-intrinsic and acquired novel resistance enabling a micro-organism to survive or multiply in the presence of an antimicrobial agent at concentrations higher than that which inhibits wild type strains of the same species;(21) "intrinsic antimicrobial resistance" means all inherent properties of a microbial species that limit the action of antimicrobial agents thereby allowing it to survive and multiply in presence of the antimicrobial agents at concentrations that are relevant for their therapeutic uses. Inherent properties of micro-organisms are considered not transferable and can include structural characteristics such as lack of drug targets, the impermeability of cellular envelopes, activity of multidrug efflux pumps, or metabolic enzymes. An antimicrobial resistance gene is considered intrinsic if it is located on a chromosome in the absence of mobile genetic element and shared by the majority of wild type strains of the same species;(22) "relevant antimicrobial activity" means the antimicrobial activity caused by relevant antimicrobial agents;(23) "relevant antimicrobial agents" means all antimicrobial agents important for therapeutic use in humans or animals, as described in the latest available versions at the time of submission of the dossier:in a list adopted by means of Commission Regulation (EU) 2021/1760 Commission Delegated Regulation (EU) 2021/1760 of 26 May 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council by establishing the criteria for the designation of antimicrobials to be reserved for the treatment of certain infections in humans (OJ L 353, 6.10.2021, p. 1 ).Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7. 1.2019, p.43 ).by the World Health Organisation https://www.who.int/publications/i/item/9789241515528.
micro-organisms are living organisms capable of replication that may be naturally present in high numbers in the environment, and the specific micro-organism under assessment may already be occurring in relevant European environments at a relevant taxonomic level, the biological properties and the mode of action of a micro-organism are the first and crucial step in the evaluation process, because they define which are the relevant aspects and elements on which the evaluation should focus, and also which aspects are not relevant for a robust informed decision making, extensive information on the micro-organism under assessment (at the relevant taxonomic level) may be available in the public domain (e.g. history of use, peer-reviewed scientific literature). Best use of this information shall be made. Where applicable, regulatory experimental studies may be needed to determine the specific properties of the micro-organism under evaluation.
(a) invertebrate pathogenicity; (b) parasitisation; (c) competition for the ecological niche (e.g. nutrients, habitats); (d) endophytic growth; (e) interference with the virulence of a pathogenic target organism; (f) induction of plant defence; (g) antibiosis.
(a) the choice of the crop or cultivar; (b) the agricultural and environmental (including climatic) conditions (if necessary for a specific use such data/information shall also be given for the time before and after application); (c) the presence and density of the target organism; (d) the development stage of crop and target organism; (e) the application rate of the plant protection product; (f) if required on the label, the application rate of adjuvant to be added; (g) the frequency and timing of the applications; (h) the type of application equipment to be used; (i) the need for any special cleaning measures for the application equipment before and after use.
(a) the level, consistency and duration of the effect sought in relation to the proposed dose; (b) the comparison of the proposed dose with a suitable reference product or products, where they exist, and an untreated control; (c) where relevant, the effect on yield or reduction of loss in storage, in terms of quantity and/or quality, in comparison with a suitable reference product or products, where they exist, and an untreated control; (d) the risk of occurrence and development of resistance or cross-resistance in populations of target organism.
(a) This evaluation shall take into consideration the following information: (i) efficacy data; (ii) other relevant information on the plant protection product such as nature of the plant protection product, dose, method of application, number and timing of applications, incompatibility with other crop treatments; (iii) all relevant information on the micro-organism, including biological properties e.g. mode of action, survival, host range specificity.
(b) This evaluation shall include: (i) the nature, frequency, level and duration of observed phytotoxic/phytopathogenic effects and the agricultural, plant health and environmental (including climatic) conditions that affect them; (ii) differences between main cultivars with regard to their sensitivity to phytotoxic/phytopathogenic effects; (iii) the part of the treated crop or plant products where phytotoxic/phytopathogenic effects are observed; (iv) adverse impact on the yield of the treated crop or plant products in terms of quantity and/or quality, and on transformation processes; (v) adverse impact on treated plants or plant products to be used for propagation, in terms of viability, germination, sprouting, rooting and establishment; (vi) where micro-organisms are disseminated, in particular for weed control, any adverse impact on adjacent crops.
(a) all relevant information as provided for under Part B of the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof, including the toxicological studies; (b) all relevant information on the plant protection product as provided for under Part B of the Annex to Regulation (EU) No 284/2013, including toxicological studies and efficacy data.
infectivity and pathogenicity; toxicity of metabolites of concern, safeners, synergists, and relevant impurities; relevant antimicrobial activity of metabolites present in the plant protection product; susceptibility to relevant antimicrobial agents to ensure the availability of sufficient treatment options in case of an opportunistic infection.
(a) the available information on infectivity and pathogenicity (e.g. based on biological properties, peer-reviewed literature, animal studies performed by the applicant) as provided for in Part B of the Annex to Regulation (EU) No 283/2013. For micro-organisms, infectivity and pathogenicity tests on animals may not always be suitable for extrapolation to humans due to differences between humans and test animals (e.g. immune system, microbiome). Micro-organisms might have a narrow host range, hence it cannot always be assumed that a micro-organism that does cause disease in the animals tested has the same result in humans, and vice-versa. Information available and provided by the applicant, as required in points 2.1, 2.3, 2.4, 2.6 and 5.1 of Part B of the Annex to Regulation (EU) No 283/2013, and/or retrieved from any other reliable sources (e.g. Qualified Presumption of Safety, peer-reviewed literature) may provide robust and reliable scientific indication on infectivity and pathogenicity of the micro-organism. Where an applicant provides a summary of information already available on infectivity and pathogenicity of the micro-organism, as described in point 5.2 of Part B of the Annex to Regulation (EU) No 283/2013, Member States shall assess such scientific evidence provided by the applicant using a weight of evidence approach, in order to evaluate whether the possible non-submission of certain studies required in points 5.3.1 and 5.4 of Part B of the Annex to Regulation (EU) No 283/2013 is justified. The evaluation shall take into consideration the following principles: to avoid unnecessary animal testing, in a first instance infectivity and pathogenicity shall be assessed on the basis of existing information as provided for under point 5.2 of Part B of the Annex to Regulation (EU) No 283/2013; infectivity and pathogenicity studies described in point 5.3.1 of Part B of the Annex to Regulation (EU) No 283/2013 may be necessary; further specific studies may be required, as indicated in point 5.4 of Part B of the Annex to Regulation (EU) No 283/2013. For instance, if there are indications of infectivity, or any adverse effects, further testing shall be conducted, taking into account the exposure scenario and an observation period suitable for the micro-organisms, to allow observing a clearance in the host. The choice of appropriate timing of the observational period may be based on available information such as biological properties of the micro-organism or other relevant available information.
The evaluation of available information and possible animal studies performed by the applicant, shall take into consideration the ability of the micro-organism to infect, persist or grow in the mammalian host, and its ability to cause effects or reactions in the host. Parameters that indicate the absence of ability to persist and multiply in the host, and the absence of ability to produce adverse effects in a host, include clearance from the body, if relevant. Replication temperatures may be different from mammalian body temperature, possibly indicating low likelihood of persistence and multiplication in the host. However, temperature adaptation may occur, and this parameter alone shall not be considered sufficient to conclude on persistence and multiplication of the micro-organism in the host. Evaluation based on relevant parameters of study results and available information shall lead to an assessment of the possible effects of occupational exposure. (b) the available information on toxicity (e.g. based on biological properties, peer-reviewed literature, animal studies performed by the applicant) as described in points 2.8 and 5.5 of Part B of the Annex to Regulation (EU) No 283/2013, and Section 7 of Part B of the Annex to Regulation (EU) No 284/2013. Information available on toxicity, such as from published literature, medical information, Integrated Approach to Testing and Assessment (IATA), results of CLP calculation rules in accordance with Regulation (EC) No 1272/2008, or bridging data from similar plant protection products, may provide robust and reliable scientific indication on the toxicity of relevant chemical substances contained in the plant protection product, and be used for classification and labelling. Where an applicant provides information available on human and animal toxicity of (chemical substances present in) the plant protection product (including in vitro andex vivo data), Member States shall assess such scientific evidence provided by the applicant using a weight of evidence approach, in order to evaluate whether the possible non-submission of certain studies required in points 7.3.1 to 7.3.6 of Part B of the Annex to Regulation (EU) No 284/2013 is justified. The evaluation shall take into consideration the following principles:to avoid unnecessary animal testing, in a first instance toxicity shall be assessed on the basis of existing information as provided for in point 7.2 of Part B of the Annex to Regulation (EU) No 284/2013; toxicity studies may be necessary; further specific studies may be required taking into consideration the intended use, according to the provisions of points 2.8 and 5.5 of Part B of the Annex to Regulation (EU) No 283/2013, and of points 7.4 and 7.7 of Part B of the Annex to Regulation (EU) No 284/2013.
The evaluation of available information and possible animal studies performed by the applicant, shall take into consideration the ability of metabolites of concern, safeners, synergists, and relevant impurities to cause adverse effects on humans or animals. Evaluation based on relevant parameters of the tests shall lead to an assessment of the possible effects of non-dietary exposure, taking into account the intensity and duration of exposure under the proposed conditions of use. (c) other relevant information provided for under Part B of the Annex to Regulation (EU) No 284/2013, such as: composition of the plant protection product, nature of the plant protection product, size, design and type of packaging.
(a) on the basis of the information referred to in point 1.5.1.2 the following overall end-points shall be established for single or repeated operator, worker, bystanders and residents exposure following the intended use, as regards: observed or expected infectivity and pathogenicity of the micro-organism(s) in the plant protection product, observed or expected adverse toxicological effects of the plant protection product due to metabolites of concern safeners, synergists, and/or relevant impurities.
(b) the evaluation of the exposure of the operator shall be made for each type of application method and application equipment proposed for the use of the plant protection product as well as for the different types and sizes of packaging containers to be used, taking into account mixing, loading operations, application of the plant protection product and cleaning and routine maintenance of application equipment. Where relevant, other authorised uses of the plant protection product in the area of envisaged use, concerning the same active substance or which give rise to the same residues, shall also be taken into account. (c) the possibility of adverse effects in humans shall be assessed with regard to measured or estimated levels of human exposure as compared to the tested dose levels, as provided for under Section 7 of Part B of the Annex to Regulation (EU) No 284/2013. This risk assessment shall include consideration of e.g. mode of action, physical and chemical properties of the micro-organism and other components in the plant protection product, such as metabolites of concern, safeners, synergists and relevant impurities. (d) other relevant information provided for under Part B of the Annex to Regulation (EU) No 284/2013, such as: field of use and nature of the crop or target, method of application including handling, mixing and loading of the plant protection product, exposure reduction measures recommended, protective clothing recommendations, maximum application rate, cleaning and routine maintenance of application equipment, , taking into account also seed treatment and good occupational practice, recommendation to be followed after application, such as re-entry period and working duration, minimum (spray) application volume stated on the label, number and timing of applications, including intervals between applications, re-entry periods, necessary waiting periods or other precautions to protect humans and animals, dried residues of the plant protection products on plants and plant products after treatment, taking into account the capacity of the micro-organism to grow in situ , and the influence of factors such as temperature, UV light, pH and the presence of certain substances,further information on exposure (e.g. operator/worker/bystander/resident exposure study, further activities whereby workers are exposed).
(a) the type of packaging; (b) its dimensions and capacity; (c) the size of the opening; (d) the type of closure; (e) its strength, leak proofness and resistance to normal transport and handling; (f) its resistance to and compatibility with the contents.
(a) obtainability and suitability; (b) effectiveness; (c) ease of wearing taking into account physical stress and climatic conditions; (d) resistance to and compatibility with the plant protection product.
the intended use, including data on application and proposed pre-harvest intervals for envisaged uses or withholding periods or storage periods in the case of post-harvest uses; analytical methods as provided for under point 5.2 of Part B of the Annex to Regulation (EU) No 284/2013; the specific information on residues in/on treated plants, plant products, food and feed as provided for in Section 8 of Part B of the Annex to Regulation (EU) No 284/2013; realistic possibilities for extrapolating data from one crop to another.
non-target organisms (concerning the exposure to the micro-organism and to the metabolites of concern); humans via the environment (concerning the exposure to the metabolites of concern).
the data on the proposed good agricultural practice, including data on application; nature of the plant protection product; analytical methods, as provided for under point 4.2 of Part B of the Annex to Regulation (EU) No 283/2013, and under point 5.2 of Part B of the Annex to Regulation (EU) No 284/2013; the specific information on occurrence of the micro-organism, e.g. possible increase of microbial density in the relevant environmental compartment compared to the occurrence at the relevant highest taxonomic level in European environments, as provided for under point 7.1 of Part B of the Annex to Regulation (EU) No 283/2013, and, where relevant, Section 9 of Part B of the Annex to Regulation (EU) No 284/2013; data extrapolated from one crop to another, if considered realistic by Member States; in addition, for micro-organisms not occurring in the relevant European environments at the relevant highest taxonomic level, and which are known to be pathogenic either for plants or for other organisms, the exposure of non-target organisms through colonised host organisms shall be evaluated taking into account also the information on the population density of the micro-organism in host organisms, and the exposure of non-target organisms to colonised host organisms.
the data on the proposed good agricultural practice, including data on application; nature of the plant protection product; analytical methods, as provided for under point 4.2 of Part B of the Annex to Regulation (EU) No 283/2013, and under point 5.2 of Part B of the Annex to Regulation (EU) No 284/2013; the specific information on environmental fate and behaviour of the metabolite of concern present in the plant protection product, as provided for under point 7.2 of Part B of the Annex to Regulation (EU) No 283/2013, and, if relevant, Section 9 of Part B of the Annex to Regulation (EU) No 284/2013; if available and if submitted by the applicant to perform a qualitative exposure assessment as provided for under point 7.2.2 of Part B of the Annex to Regulation (EU) No 283/2013, on background level of the same metabolite of concern in the relevant environmental compartments; realistic possibilities of extrapolating data from one crop to another.
(a) conditions of use; (b) information on fate and behaviour as provided in Section 9 of Part B of the Annex to Regulation (EU) No 284/2013.
(a) Member States shall evaluate the risks to terrestrial vertebrates due to the micro-organism and its potential to infect and multiply in the host, taking into account the following information on the micro-organism: mode of action; other biological properties; studies on mammalian infectivity and pathogenicity; studies on avian infectivity and pathogenicity; other relevant information on terrestrial vertebrate infectivity and pathogenicity.
(b) Member States shall evaluate the risk to terrestrial vertebrates due to toxic effects of the plant protection product in accordance with relevant provisions referred to in point 1.5.2.1 of Part A.
(a) Member States shall evaluate the risks to aquatic organisms due to the micro-organism and its potential to infect and multiply the host, taking into account the following information on the micro-organism: its mode of action; other biological properties; studies on infectivity and pathogenicity to aquatic organisms and/or other existing relevant information.
(b) Member States shall evaluate the risk to aquatic organisms due to toxic effects of the plant protection product in accordance with relevant provisions referred to in point 1.5.2.2 of Part A.
(a) Member States shall evaluate the risks to bees due to the micro-organism and its potential to infect and multiply the host, taking into account the following information on the micro-organism: its mode of action; other biological properties; studies on infectivity and pathogenicity to bees and/or other existing relevant information.
(b) Member States shall evaluate the risk to bees due to toxic effects of the plant protection product, in accordance with relevant provisions referred to in point 1.5.2.3 of Part A.
(a) Member States shall evaluate the risks to arthropods other than bees due to the micro-organism and its potential to infect and multiply the host, taking into account the following information on the micro-organism: its mode of action; other biological properties; studies on infectivity and pathogenicity to honeybees and other arthropods and/or other existing relevant information.
(b) Member States shall evaluate the risk to arthropods other than bees due to toxic effects of the plant protection product in accordance with relevant provisions referred to in point 1.5.2.4 of Part A.
(a) Member States shall evaluate the risks to meso- and macroorganisms in soil due to the micro-organism and its potential to infect and multiply the host, taking into account the following information on the micro-organism: its mode of action; other biological properties; studies on infectivity and pathogenicity to meso- and macro-organisms and/or other existing relevant information.
(b) Member States shall evaluate the risk to meso- and macro-organisms in soil due to toxic effects of the plant protection product in accordance with relevant provisions referred to in point 1.5.2.5 of part A.
(a) Member States shall evaluate the risks to terrestrial plants due to the micro-organism and its potential to infect and multiply the host, taking into account the following information on the micro-organism: its mode of action; other biological properties; studies on infectivity and pathogenicity to terrestrial plants; relatedness to known plant-pathogens.
(b) Member States shall evaluate the risk to terrestrial plants due to toxic effects of the plant protection product.
the evaluation conducted in accordance with Directive 2001/18/EC as well as the relevant decision taken by the Member States has been provided by the applicant in the dossier, and an authorisation is granted in accordance with Part C of Directive 2001/18/EC under which that organism can be released into the environment, or placed on the market in a plant protection product.
recommendations for the control of or protection against target organisms, or any other effects, which are not considered to cause adverse effects on crops, plants, or plant products; or, effects which are not considered to be beneficial under those conditions.
(a) plants, plant products, foodstuffs of plant and animal origin and feeding stuffs if relevant residues occur. Residues are considered relevant if a MRL or a waiting or re-entry safety period or other such precaution is required; (b) soil, water, air and/or body fluids and tissues, in those compartments where toxicologically, ecotoxicologically or environmentally relevant residues occur.
effective and in accordance with Regulation (EU) 2016/425 of the European Parliament and of the Council Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51 ).readily obtainable by the user, feasibly usable under the claimed conditions of use of the plant protection product, taking into account climatic conditions in particular.
the surface water in or from the area of envisaged use is intended for the abstraction of drinking water; and this contamination exceeds the parameters or values established in accordance with Directive 2000/60/EC.
(i) the maximum permissible concentration laid down by Council Directive 98/83/EC Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, p. 32 ).(ii) the maximum concentration laid down when approving the active substance in accordance with Regulation (EC) No 1107/2009, based on appropriate data, in particular toxicological data, or, where that concentration has not been laid down, the concentration corresponding to one tenth of the ADI laid down when the active substance was approved Where the ADI is not available for a metabolite of concern, the default value of 0.1 μg/l applies.
(a) if the micro-organism is pathogenic to terrestrial vertebrates, (b) in case of toxic effects of the plant protection product, if the acute and short-term toxicity/exposure ratio for terrestrial vertebrates is less than 10 on the basis of LD 50 (acute dietary risk assessment) 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 no unacceptable impact occurs, directly or indirectly, after use of the plant protection product in accordance with the proposed conditions of use.
(a) if the micro-organism is pathogenic to aquatic organisms, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on aquatic organism populations would occur after use of the plant protection product in accordance with the proposed conditions of use; or (b) in case of toxic effects of the plant protection product if the: toxicity/exposure ratio for fish and Daphnia is less than 100 for acute exposure and less than 10 for long-term exposure, or algal growth inhibition/exposure ratio is less than 10,
unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on exposed species occurs, directly or indirectly, after use of the plant protection product in accordance with the proposed conditions of use.
(a) if the micro-organism is pathogenic to bees under the proposed conditions of use, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact is expected to occur to the populations of bees after use of the plant protection product in accordance with the proposed conditions of use; or (b) in case of toxic effects of the plant protection product, as defined in the decision-making principles of point 2.5.2.3 of Part A.
(a) if the micro-organism is pathogenic to arthropods other than bees, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact is expected to occur to the populations of arthropods other than bees after use of the plant protection product in accordance with the proposed conditions of use; or (b) in case of toxic effects of the plant protection product, as defined in the decision-making principles of point 2.5.2.4 of Part A, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on arthropods other than bees 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.
(a) if the micro-organism is pathogenic to meso- and macro-organisms in soil, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on soil meso- and macro-organism populations occurs after use of the plant protection product in accordance with the proposed conditions of use; or (b) in the case of toxic effects of the plant protection product, if the acute toxicity/exposure ratio for meso- and macro-organisms in soil 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 no unacceptable impact on soil meso- and macro-organism populations occur after use of the plant protection product in accordance with the proposed conditions of use.
(1) "efficacy" means a measure concerning the overall effect of the application of a plant protection product on the agricultural system in which it is used (i.e. which includes positive effects of treatment in performing the desired plant protection activity and negative effects such as development of resistance, phytotoxicity or reduction of qualitative or quantitative yield);(2) "relevant impurity" means a chemical impurity that is of concern for human health, animal health or the environment;(3) "storage stability" means the capacity of a plant protection product to maintain the initial properties and the specified content during the storage period under established storage conditions.
(a) ensure that dossiers supplied are in accordance with the requirements of the Annex to Commission Regulation (EU) No 284/2013 Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 93, 3.4.2013, p. 85 ).ensure that the data submitted by the applicant are acceptable in terms of quantity, quality, consistency and reliability and sufficient to permit a proper evaluation of the dossier, evaluate, where relevant, justifications submitted by the applicant for not supplying certain data;
(b) take into account the data concerning the active substance in the plant protection product of the Annex to Commission Regulation (EU) No 283/2013 Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 93, 3.4.2013, p. 1 ).(c) take into consideration other relevant technical or scientific information with regard to the efficacy of the plant protection product or to the potentially adverse effects of the plant protection product its components or its residues, where relevant.
(a) identify the risks arising, assess their significance and the expected exposure, and make a judgement as to the likely risks to humans, animals or the environment; (b) assess efficacy in terms of effectiveness (including possible development of resistance or cross-resistance of the target organism(s)) and adverse effects (including phytotoxicity/pathogenicity) on crops (including treated crops, succeeding crops and adjacent crops) of the plant protection product for each use for which authorisation is sought.
(a) make a best possible estimation in an appropriate way of all relevant processes involved taking into account realistic parameters and assumptions; (b) be submitted to an evaluation as referred to in point 2.3; (c) be reliably validated with measurements carried out under circumstances relevant for the use of the model; (d) be relevant to the conditions in the area of use; (e) in cases the models have not been validated, be supported with details indicating how the model calculates estimates provided, and explanations of all the inputs to the model and details of how they have been derived.
(a) fulfils the requirements setting out in Regulation (EU) No 547/2011; (b) also contains the information on protection of operators, workers, bystanders and residents required by EU legislation on worker protection; (c) specifies in particular the conditions or restrictions under which the plant protection product may or may not be used as referred to in points 3.1 to 3.5 of this general introduction.
(a) ensure that the proposed packaging is in accordance with the provisions of Regulation (EC) No 1272/2008; (b) ensure that the following procedures are in accordance with the relevant regulatory provisions: the procedures for destruction of the plant protection product, the procedures for neutralisation of any adverse effects of the plant protection product if it is accidentally dispersed, and the procedures for the decontamination and destruction of the packaging.
(a) when one or more of the specific decision-making requirements referred to in points 2.1, 2.2, 2.3 or 2.7 of Part A, or point 2.3 of Part B, respectively, are not 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 aforementioned requirements must be mentioned on the label, and non-compliance with the requirements referred to in point 2.7 of Part A (if Part A applies) shall not compromise proper use of the plant protection product. These advantages can be in terms of: advantages for and compatibility with integrated control measures or organic farming, facilitating strategies to minimise the risk of development of resistance, the need for a greater diversity of types of active substances or biochemical modes of action, e.g. for use in strategies to avoid accelerated breakdown in the soil, reduced risk for operators and consumers, reduced contamination of the environment and reduced impact on non-target species.
(b) where the criteria referred to in point 2.6 of Part A or point 2.4 of Part B, respectively, are not fully satisfied because of limitations in current analytical science and technology, authorisation shall be granted for a limited period if the methods submitted prove adequate for the purposes intended. In this case, the applicant shall be required to develop and submit analytical methods that are in accordance with those criteria by a specific deadline. The authorisation shall be reviewed on expiry of that deadline; (c) where the reproducibility of the submitted analytical methods referred to in point 2.6 of Part A or point 2.4 of Part B, respectively has only been verified in two laboratories, an authorisation shall be granted for 1 year to permit the applicant to demonstrate the reproducibility of those methods in accordance with agreed criteria in at least a third laboratory.
(a) define, where possible, preferably in close cooperation with the applicant, measures to improve the efficacy of the plant protection product; and/or (b) define, where possible, in close cooperation with the applicant, measures to reduce further the exposure that could occur during and after use of the plant protection product.
the choice of the crop or cultivar, the agricultural and environmental (including climatic) conditions, the presence and density of the harmful organism, the development stage of crop and organism, the amount of the plant protection product used, if required on the label, the amount of adjuvant added, the frequency and timing of the applications, the type of application equipment.
(i) the level, consistency and duration of the effect sought in relation to the dose in comparison with a suitable reference product or products and an untreated control; (ii) where relevant, effect on yield or reduction of loss in storage, in terms of quantity and/or quality, in comparison with a suitable reference product or products and an untreated control.
(a) This evaluation shall take into consideration the following information: (i) the efficacy data provided for in the Annex to Regulation (EU) No 284/2013; (ii) other relevant information on the plant protection product such as nature of the preparation, dose, method of application, number and timing of applications; (iii) all relevant information on the active substance as provided for in of the Annex to Regulation (EU) No 283/2013, including mode of action, vapour pressure, volatility and water solubility.
(b) This evaluation shall include: (i) the nature, frequency, level and duration of observed phytotoxic effects and the agricultural, plant health and environmental (including climatic) conditions that affect them; (ii) the differences between main cultivars with regard to their sensitivity to phytotoxic effects; (iii) the part of the treated crop or plant products where phytotoxic effects are observed; (iv) the adverse impact on the yield of the treated crop or plant products in terms of quantity and/or quality; (v) the adverse impact on treated plants or plant products to be used for propagation, in terms of viability, germination, sprouting, rooting and establishment; (vi) where volatile products are concerned, the adverse impact on adjacent crops.
(i) all relevant information as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof, including the toxicological and metabolism studies; (ii) all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013, including toxicological studies and efficacy data.
(a) This evaluation shall take into consideration the following information: (i) the toxicological and metabolism studies as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof including the acceptable operator exposure level (AOEL). The acceptable operator exposure level is the maximum amount of active substance to which the operator may be exposed without any adverse health effects. The AOEL is expressed as milligrams of the chemical per kilogram body weight of the operator. The AOEL is based on the highest level at which no adverse effect is observed in tests in the most sensitive relevant animal species or, if appropriate data are available, in humans; (ii) other relevant information on the active substances such as physical and chemical properties; (iii) the toxicological studies provided for in the Annex to Regulation (EU) No 284/2013, including where appropriate dermal absorption studies; (iv) other relevant information as provided for in the Annex to Regulation (EU) No 284/2013 such as: composition of the preparation, nature of the preparation, size, design and type of packaging, field of use and nature of crop or target, method of application including handling, loading and mixing of product, exposure reduction measures recommended, protective clothing recommendations, maximum application rate, minimum spray application volume stated on the label, number and timing of applications.
(b) This evaluation shall be made for each type of application method and application equipment proposed for use of the plant protection product as well as for the different types and sizes of containers to be used, taking account of mixing, loading operations, application of the plant protection product and cleaning and routine maintenance of application equipment.
the type of packaging, its dimensions and capacity, the size of the opening, the type of closure, its strength, leakproofness and resistance to normal transport and handling, its resistance to and compatibility with the contents.
obtainability and suitability, ease of wearing taking into account physical stress and climatic conditions.
(i) the toxicological and metabolism studies on the active substance as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof, including the acceptable operator exposure level; (ii) the toxicological studies provided for in the Annex to Regulation (EU) No 284/2013, including where appropriate dermal absorption studies; (iii) other relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013 such as: re-entry periods, necessary waiting periods or other precautions to protect humans and animals, method of application, in particular spraying, maximum application rate, maximum spray application volume, composition of the preparation, excess remaining on plants and plant products after treatment, further activities whereby workers are exposed.
the determination of an acceptable daily intake (ADI), the identification of metabolites, degradation and reaction products in treated plants or plant products, behaviour of residues of the active substance and its metabolites from the time of application until harvest, or in the case of postharvest uses, until outloading of stored plant products.
data on the proposed good agricultural practice, including data on application as provided for in the Annex to Regulation (EU) No 284/2013 and proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses, nature of the preparation, analytical methods and the residue definition.
(i) the proposed conditions of use of the plant protection product; (ii) the specific information on residues in or on treated plants, plant products, food and feed as provided for in the Annex to Regulation (EU) No 284/2013 and the distribution of residues between edible and non-edible parts; (iii) the specific information on residues in or on treated plants, plant products, food and feed as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (iv) the realistic possibilities of extrapolating data from one crop to another.
(i) the specific information on fate and behaviour in soil as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: molecular weight, solubility in water, octanol/water partition coefficient, vapour pressure, volatilisation rate, dissociation constant, photodegradation rate and identity of breakdown products, hydrolysis rate in relation to pH and identity of breakdown products.
(iii) all information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013, including the information on distribution and dissipation in soil; (iv) where relevant, other authorised uses of plant protection products in the area of proposed use containing the same active substance or which give rise to the same residues.
(i) the specific information on fate and behaviour in soil and water as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: molecular weight, solubility in water, octanol/water partition coefficient, vapour pressure, volatilisation rate, hydrolysis rate in relation to pH and identity of breakdown products, dissociation constant;
(iii) all information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013, including the information on distribution and dissipation in soil and water; (iv) where relevant, other authorised uses of plant protection products in the area of envisaged use containing the same active substance or which give rise to the same residues; (v) where relevant, data on dissipation including transformation and sorption in the saturated zone; (vi) where relevant, data on the procedures for drinking water abstraction and treatment in the area of envisaged use; (vii) where relevant, monitoring data on the presence or absence of the active substance and relevant metabolites, degradation or reaction products in groundwater as a result of previous use of plant protection products containing the same active substance or which give rise to the same residues; such monitoring data shall be interpreted in a consistent scientific way.
(i) the specific information on fate and behaviour in soil and water as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: molecular weight, solubility in water, octanol/water partition coefficient, vapour pressure, volatilisation rate, hydrolysis rate in relation to pH and identity of breakdown products, dissociation constant;
(iii) all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013, including the information on distribution and dissipation in soil and water; (iv) possible routes of exposure: drift, run-off, overspray, discharge via drains, leaching, deposit from the atmosphere;
(v) where relevant, other authorised uses of plant protection products in the area of envisaged use containing the same active substance or which give rise to the same residues; (vi) where relevant, data on the procedures for drinking water abstraction and treatment in the area of envisaged use.
(i) the specific information on fate and behaviour in soil, water and air as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: vapour pressure, solubility in water, hydrolysis rate in relation to pH and identity of breakdown products, photochemical degradation in water and air and identity of breakdown products, octanol/water partition coefficient;
(iii) all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013, including the information on distribution and dissipation in air.
(a) This evaluation shall take into consideration the following information: (i) the specific information relating to toxicological studies on mammals and to the effects on birds and other non-target terrestrial vertebrates, including effects on reproduction, and other relevant information concerning the active substance as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013, including the information on effects on birds and other non-target terrestrial vertebrates; (iii) where relevant, other authorised uses of plant protection products in the area of envisaged use containing the same active substance or which give rise to the same residues.
(b) This evaluation shall include: (i) the fate and distribution, including persistence and bioconcentration, of the active substance and of relevant metabolites, breakdown and reaction products in the various parts of the environment after application of the plant protection product; (ii) the estimated exposure of the species likely to be exposed at the time of application or during the period that residues are present, taking into account all relevant routes of exposure such as ingestion of the formulated product or treated food, predation on invertebrates, feeding on vertebrate prey, contact by overspraying or with treated vegetation; (iii) a calculation of the acute, short-term and, where necessary, long-term toxicity/exposure ratio. The toxicity/exposure ratios are defined as respectively the quotient of LD 50 , LC50 or non-observable effects of concentration (NOEC) expressed on an active substance basis and the estimated exposure expressed in mg/kg body weight.
(a) This evaluation shall take into consideration the following information: (i) the specific information relating to the effects on aquatic organisms as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: solubility in water, octanol/water partition coefficient, vapour pressure, volatilisation rate, KOC, biodegradation in aquatic systems and in particular the ready biodegradability, photodegradation rate and identity of breakdown products, hydrolysis rate in relation to pH and identity of breakdown products.
(iii) all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013 and in particular the effects on aquatic organisms; (iv) where relevant, other authorised uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues.
(b) This evaluation shall include: (i) the fate and distribution of residues of the active substance and of relevant metabolites, breakdown and reaction products in water, sediment or fish; (ii) a calculation of the acute toxicity/exposure ratio for fish and Daphnia. This ratio is defined as the quotient of respectively acute LC 50 or EC50 and the predicted short-term environmental concentration;(iii) a calculation of the algal growth inhibition/exposure ratio for algae. This ratio is defined as the quotient of the EC 50 and the predicted short-term environmental concentration;(iv) a calculation of the long-term toxicity/exposure ratio for fish and Daphnia. The long-term toxicity/exposure ratio is defined as the quotient of the NOEC and the predicted long-term environmental concentration; (v) where relevant, the bioconcentration in fish and possible exposure of predators of fish, including humans; (vi) if the plant protection product is to be applied directly to surface water, the effect on the change of surface water quality, such as pH or dissolved oxygen content.
(a) This evaluation shall take into consideration the following information: (i) the specific information on toxicity to honeybees as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: solubility in water, octanol/water partition coefficient, vapour pressure, photodegradation rate and identity of breakdown products, mode of action (e. g. insect growth regulating activity);
(iii) all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013, including the toxicity to honeybees; (iv) where relevant, other authorised uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues.
(b) This evaluation shall include: (i) the ratio between the maximum application rate expressed in grams of active substance per hectare and the contact and oral LD 50 expressed in μg of active substance per bee (hazard quotients) and where necessary the persistence of residues on or, where relevant, in the treated plants;(ii) where relevant, the effects on honeybee larvae, honeybee behaviour, colony survival and development after use of the plant protection product in accordance with the proposed conditions of use.
(i) the specific information on toxicity to honeybees and other beneficial arthropods as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: solubility in water, octanol/water partition coefficient, vapour pressure, photodegradation rate and identity of breakdown products, mode of action (e. g. insect growth regulating activity);
(iii) all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013 such as: effects on beneficial arthropods other than bees, toxicity to honeybees, available data from biological primary screening, maximum application rate, maximum number and timetable of applications;
(iv) where relevant, other authorised uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues.
(a) This evaluation shall take into consideration the following information: (i) the specific information relating to the toxicity of the active substance to earthworms and to other non-target soil macro-organisms as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: solubility in water, octanol/water partition coefficient, Kd for adsorption, vapour pressure, hydrolysis rate in relation to pH and identity of breakdown products, photodegradation rate and identity of breakdown products, DT 50 and DT90 for degradation in the soil.
(iii) all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013, including the effects on earthworms and other non-target soil macro-organisms; (iv) where relevant, other authorised uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues.
(b) This evaluation shall include: (i) the lethal and sublethal effects; (ii) the predicted initial and long-term environmental concentration; (iii) a calculation of the acute toxicity/exposure ratio (defined as the quotient of LC 50 and predicted initial environmental concentration) and of the long-term toxicity/exposure ratio (defined as the quotient of the NOEC and predicted long-term environmental concentration);(iv) where relevant, the bioconcentration and persistence of residues in earthworms.
(i) all relevant information on the active substance, including the specific information relating to the effects of non-target soil micro-organisms as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013, including the effects on non-target soil micro-organisms; (iii) where relevant, other authorised uses of plant protection products in the area of proposed use, containing the same active substance or which give rise to the same residues; (iv) all available information from biological primary screening.
(i) the data on analytical methods as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) the data on analytical methods as provided for in the Annex to Regulation (EU) No 284/2013 and in particular: the specificity and linearity of the proposed methods, the importance of interferences, the precision of the proposed methods (intralaboratory repeatability and interlaboratory reproducibility);
(iii) the limit of detection and determination of the proposed methods for impurities.
(i) the data on analytical methods as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) the data on analytical methods as provided for in the Annex to Regulation (EU) No 284/2013 and in particular: the specificity of the proposed methods, the precision of the proposed methods (intralaboratory repeatability and interlaboratory reproducibility), the recovery rate of the proposed methods at appropriate concentrations;
(iii) the limit of detection of the proposed methods; (iv) the limit of determination of the proposed methods.
where a suitable FAO (Food and Agriculture Organisation of the United Nations) specification exists, the physical and chemical properties addressed in that specification, where no suitable FAO specification exists, all the relevant physical and chemical properties for the formulation as referred to in the "Manual on development and use of FAO and WHO specifications for pesticides".
(i) the data on the physical and chemical properties of the active substance as provided for in the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof; (ii) the data on the physical and chemical properties of the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013.
death is synchronous with the extinction of consciousness, or death occurs immediately, or vital functions are reduced gradually without signs of obvious suffering.
(i) acute toxicity category 1 and 2 for any route of uptake, provided the ATE (acute toxicity estimate) of the product does not exceed 25 mg/kg bw for the oral route of uptake or 0,25 mg/l/4h for the inhalation of dust, mist or fume; (ii) STOT (single exposure), category 1 (oral), provided their classification is due to the presence of classified substances showing significant non-lethal toxic effects at guidance values below 25 mg/kg bw; (iii) STOT (single exposure), category 1 (dermal), provided their classification is due to the presence of classified substances showing significant non-lethal toxic effects at guidance values below 50 mg/kg bw; (iv) STOT (single exposure), category 1 (inhalation of gas/vapour), provided their classification is due to the presence of classified substances showing significant non-lethal toxic effects at guidance values below 0,5 mg/l/4h; (v) STOT (single exposure), category 1 (inhalation of dust/mist/fume), provided their classification is due to the presence of classified substances showing significant non-lethal toxic effects at guidance values below 0,25 mg/l/4h.
during tests in the field, persist in soil for more than 1 year (i.e. DT 90 > 1 year and DT50 > 3 months), orduring laboratory tests, form non-extractable residues in amounts exceeding 70 % of the initial dose after 100 days with a mineralisation rate of less than 5 % in 100 days,
(i) the maximum permissible concentration laid down by Council Directive 98/83/EC Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, p. 32 ).(ii) the maximum concentration laid down when approving the active substance in accordance with Regulation (EC) No 1107/2009, on the basis of appropriate data, in particular toxicological data, or, where that concentration has not been laid down, the concentration corresponding to one tenth of the ADI laid down when the active substance was approved in accordance with Regulation (EC) No 1107/2009,
exceeds, where the surface water in or from the area of envisaged use is intended for the abstraction of drinking water, concentrations above which compliance with drinking water quality established in accordance with Directive 2000/60/EC of the European Parliament and of the Council Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1 ).has an impact deemed unacceptable on non-target species, including animals, in accordance with the relevant requirements provided for in point 2.5.2.
the acute and short-term toxicity/exposure ratio for birds and other non-target terrestrial vertebrates is less than 10 on the basis of LD 50 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 no unacceptable impact occurs after use of the plant protection product in accordance with the proposed conditions of use,the bioconcentration factor (BCF, related to fat tissue) is greater than 1, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable effects occur — directly or indirectly — after use of the plant protection product in accordance with the proposed conditions of use.
the toxicity/exposure ratio for fish and Daphnia is less than 100 for acute exposure and less than 10 for long-term exposure, or the algal growth inhibition/exposure ratio is less than 10, or the maximum bioconcentration factor (BCF) is greater than 1000 for plant protection products containing active substances which are readily biodegradable or greater than 100 for those which are not readily biodegradable,
(i) the method must be able to determine and confirm residues of toxicological, ecotoxicological or environmental significance; (ii) the mean recovery rates should be between 70 % and 110 % with a relative standard deviation of ≤ 20 %; (iii) the repeatability must be less than the following values for residues in foodstuffs: Residue level mg/kg Difference mg/kg Difference in % 0,01 0,005 50 0,1 0,025 25 1 0,125 12,5 > 1 12,5 Intermediate values shall be determined by interpolation from a log-log graph; (iv) the reproducibility must be less than the following values for residues in foodstuffs: Residue level mg/kg Difference mg/kg Difference in % 0,01 0,01 100 0,1 0,05 50 1 0,25 25 > 1 25 Intermediate values are determined by interpolation from a log-log graph; (v) in the case of residue analysis in treated plants, plant products, foodstuffs, feedingstuffs or products of animal origin, except where the MRL or the proposed MRL is at the limit of determination, the sensitivity of the methods proposed must satisfy the following criteria: Limit of determination in relation to the proposed provisional or EU MRL: MRL (mg/kg) limit of determination (mg/kg) > 0,5 0,1 0,5 –0,05 0,1 –0,02 < 0,05 MRL × 0,5
(a) Chemical properties: Throughout the shelf-life period, the difference between the stated and the actual content of the active substance in the plant protection product must not exceed the following values: Declared content in g/kg or g/l at 20 °C Tolerance up to 25 ± 15 % homogeneous formulation± 25 % non-homogeneous formulationmore than 25 up to 100 ± 10 %more than 100 up to 250 ± 6 %more than 250 up to 500 ± 5 %more than 500 ± 25 g/kg or ±25 g/l(b) Physical properties: The plant protection product must fulfil the physical criteria (including storage stability) specified for the relevant formulation type in the "Manual on the development and use of FAO and WHO specifications for plant protection products".
(1) "strain" means a genetic variant of an organism in its taxonomic level (species) that is made up of the descendants of a single isolation in pure culture from the original matrix (e.g. the environment) and usually is made up of a succession of cultures ultimately derived from an initial single colony;(2) "Microbial Pest Control Agent as manufactured" ("MPCA as manufactured") means the outcome of the manufacturing process of the micro-organism(s) intended to be used as active substance in plant protection products, consisting of the micro-organism(s) and any additives, metabolites (including metabolites of concern), chemical impurities (including relevant impurities), contaminating micro-organisms (including relevant contaminating micro-organisms) and the spent medium/rest fraction resulting from the manufacturing process or, in case of a continuous manufacturing processes where a strict separation between the manufacturing of the micro-organism(s) and the production process of the plant protection product is not possible, a non-isolated intermediate;(3) "relevant contaminating micro-organism" means a pathogenic/infective micro-organism unintentionally present in the MPCA as manufactured;(4) "spent medium/rest fraction" means the fraction of the MPCA as manufactured consisting of remaining or transformed starting materials, and excluding the micro-organism(s) that is the active substance, metabolites of concern, additives, relevant contaminating micro-organisms, and relevant impurities;(5) "starting material" means substances used in the manufacturing process of the MPCA as manufactured as substrate and/or buffering agent;(6) "ecological niche" means an ecological function and actual physical spaces occupied by a particular species within the community or ecosystem;(7) "host range" means the range of different biological host-species that can be infected by a microbial species or strain;(8) "infectivity" means the ability of a micro-organism to cause an infection;(9) "infection" means the non-opportunistic introduction or entry of a micro-organism into a susceptible host, where the micro-organism is able to reproduce to form new infective units and persist in the host, whether or not it causes pathological effects or disease;(10) "pathogenicity" means the non-opportunistic ability of a micro-organism to inflict injury and damage to the host upon infection;(11) "non-opportunistic" means a condition under which a micro-organism exerts an infection or inflicts injury or damage when the host is not weakened by a predisposing factor (e.g. immune system impaired by an unrelated cause);(12) "opportunistic infection" means an infection occurring in a host weakened by a predisposing factor (e.g. immune system impaired by an unrelated cause);(13) "virulence" means the degree of pathogenicity that a pathogenic micro-organism is able to exert in the host;(14) "metabolite of concern" means a metabolite produced by the micro-organism under assessment, with known toxicity or known relevant antimicrobial activity, which is present in the MPCA as manufactured at levels that may present a risk to human health, animal health or the environment, and/or for which it cannot be adequately justified thatin-situ production of the metabolite is not relevant for the risk assessment;(15) "background level of a metabolite" means a level of a metabolite that is likely to occur in relevant European environments (including also sources different than those of plant protection) and/or in food and feed (e.g. edible plant parts), when the micro-organisms are in conditions to grow, reproduce and to produce such metabolite in presence of a host or availability of carbon and nutrient sources, under consideration of high host densities and nutrients;(16) " means the production of a metabolite by the micro-organism after application of the plant protection product containing that micro-organism;in-situ production"(17) "antibiosis" means a relationship between two or more species in which one species is actively harmed (as by the production of toxins by the harming species);(18) "antimicrobial resistance" ("AMR") means the intrinsic or acquired ability of a micro-organism to multiply in the presence of an antimicrobial agent at concentrations which are relevant for therapeutic measures in human or veterinary medicine, making that substance therapeutically ineffective;(19) "antimicrobial agent" means any antibacterial, antiviral, antifungal, anthelmintic or antiprotozoal agent that is a substance of natural, semi-synthetic, or synthetic origin that atin vivo concentrations kills or inhibits the growth of micro-organisms by interacting with a specific target;(20) "acquired antimicrobial resistance" means a non-intrinsic and acquired novel resistance enabling a micro-organism to survive or multiply in the presence of an antimicrobial agent at concentrations higher than that which inhibits wild type strains of the same species;(21) "intrinsic antimicrobial resistance" means all inherent properties of a microbial species that limit the action of antimicrobial agents thereby allowing it to survive and multiply in presence of the antimicrobial agents at concentrations that are relevant for their therapeutic uses. Inherent properties of micro-organisms are considered not transferable and can include structural characteristics such as lack of drug targets, the impermeability of cellular envelopes, activity of multidrug efflux pumps, or metabolic enzymes. An antimicrobial resistance gene is considered intrinsic if it is located on a chromosome in the absence of mobile genetic element and shared by the majority of wild type strains of the same species;(22) "relevant antimicrobial activity" means the antimicrobial activity caused by relevant antimicrobial agents;(23) "relevant antimicrobial agents" means all antimicrobial agents important for therapeutic use in humans or animals, as described in the latest available versions at the time of submission of the dossier:in a list adopted by means of Commission Regulation (EU) 2021/1760 Commission Delegated Regulation (EU) 2021/1760 of 26 May 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council by establishing the criteria for the designation of antimicrobials to be reserved for the treatment of certain infections in humans (OJ L 353, 6.10.2021, p. 1 ).Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7. 1.2019, p.43 ).by the World Health Organisation https://www.who.int/publications/i/item/9789241515528.
micro-organisms are living organisms capable of replication that may be naturally present in high numbers in the environment, and the specific micro-organism under assessment may already be occurring in relevant European environments at a relevant taxonomic level, the biological properties and the mode of action of a micro-organism are the first and crucial step in the evaluation process, because they define which are the relevant aspects and elements on which the evaluation should focus, and also which aspects are not relevant for a robust informed decision making, extensive information on the micro-organism under assessment (at the relevant taxonomic level) may be available in the public domain (e.g. history of use, peer-reviewed scientific literature). Best use of this information shall be made. Where applicable, regulatory experimental studies may be needed to determine the specific properties of the micro-organism under evaluation.
(a) invertebrate pathogenicity; (b) parasitisation; (c) competition for the ecological niche (e.g. nutrients, habitats); (d) endophytic growth; (e) interference with the virulence of a pathogenic target organism; (f) induction of plant defence; (g) antibiosis.
(a) the choice of the crop or cultivar; (b) the agricultural and environmental (including climatic) conditions (if necessary for a specific use such data/information shall also be given for the time before and after application); (c) the presence and density of the target organism; (d) the development stage of crop and target organism; (e) the application rate of the plant protection product; (f) if required on the label, the application rate of adjuvant to be added; (g) the frequency and timing of the applications; (h) the type of application equipment to be used; (i) the need for any special cleaning measures for the application equipment before and after use.
(a) the level, consistency and duration of the effect sought in relation to the proposed dose; (b) the comparison of the proposed dose with a suitable reference product or products, where they exist, and an untreated control; (c) where relevant, the effect on yield or reduction of loss in storage, in terms of quantity and/or quality, in comparison with a suitable reference product or products, where they exist, and an untreated control; (d) the risk of occurrence and development of resistance or cross-resistance in populations of target organism.
(a) This evaluation shall take into consideration the following information: (i) efficacy data; (ii) other relevant information on the plant protection product such as nature of the plant protection product, dose, method of application, number and timing of applications, incompatibility with other crop treatments; (iii) all relevant information on the micro-organism, including biological properties e.g. mode of action, survival, host range specificity.
(b) This evaluation shall include: (i) the nature, frequency, level and duration of observed phytotoxic/phytopathogenic effects and the agricultural, plant health and environmental (including climatic) conditions that affect them; (ii) differences between main cultivars with regard to their sensitivity to phytotoxic/phytopathogenic effects; (iii) the part of the treated crop or plant products where phytotoxic/phytopathogenic effects are observed; (iv) adverse impact on the yield of the treated crop or plant products in terms of quantity and/or quality, and on transformation processes; (v) adverse impact on treated plants or plant products to be used for propagation, in terms of viability, germination, sprouting, rooting and establishment; (vi) where micro-organisms are disseminated, in particular for weed control, any adverse impact on adjacent crops.
(a) all relevant information as provided for under Part B of the Annex to Regulation (EU) No 283/2013 and the results of the evaluation thereof, including the toxicological studies; (b) all relevant information on the plant protection product as provided for under Part B of the Annex to Regulation (EU) No 284/2013, including toxicological studies and efficacy data.
infectivity and pathogenicity; toxicity of metabolites of concern, safeners, synergists, and relevant impurities; relevant antimicrobial activity of metabolites present in the plant protection product; susceptibility to relevant antimicrobial agents to ensure the availability of sufficient treatment options in case of an opportunistic infection.
(a) the available information on infectivity and pathogenicity (e.g. based on biological properties, peer-reviewed literature, animal studies performed by the applicant) as provided for in Part B of the Annex to Regulation (EU) No 283/2013. For micro-organisms, infectivity and pathogenicity tests on animals may not always be suitable for extrapolation to humans due to differences between humans and test animals (e.g. immune system, microbiome). Micro-organisms might have a narrow host range, hence it cannot always be assumed that a micro-organism that does cause disease in the animals tested has the same result in humans, and vice-versa. Information available and provided by the applicant, as required in points 2.1, 2.3, 2.4, 2.6 and 5.1 of Part B of the Annex to Regulation (EU) No 283/2013, and/or retrieved from any other reliable sources (e.g. Qualified Presumption of Safety, peer-reviewed literature) may provide robust and reliable scientific indication on infectivity and pathogenicity of the micro-organism. Where an applicant provides a summary of information already available on infectivity and pathogenicity of the micro-organism, as described in point 5.2 of Part B of the Annex to Regulation (EU) No 283/2013, Member States shall assess such scientific evidence provided by the applicant using a weight of evidence approach, in order to evaluate whether the possible non-submission of certain studies required in points 5.3.1 and 5.4 of Part B of the Annex to Regulation (EU) No 283/2013 is justified. The evaluation shall take into consideration the following principles: to avoid unnecessary animal testing, in a first instance infectivity and pathogenicity shall be assessed on the basis of existing information as provided for under point 5.2 of Part B of the Annex to Regulation (EU) No 283/2013; infectivity and pathogenicity studies described in point 5.3.1 of Part B of the Annex to Regulation (EU) No 283/2013 may be necessary; further specific studies may be required, as indicated in point 5.4 of Part B of the Annex to Regulation (EU) No 283/2013. For instance, if there are indications of infectivity, or any adverse effects, further testing shall be conducted, taking into account the exposure scenario and an observation period suitable for the micro-organisms, to allow observing a clearance in the host. The choice of appropriate timing of the observational period may be based on available information such as biological properties of the micro-organism or other relevant available information.
The evaluation of available information and possible animal studies performed by the applicant, shall take into consideration the ability of the micro-organism to infect, persist or grow in the mammalian host, and its ability to cause effects or reactions in the host. Parameters that indicate the absence of ability to persist and multiply in the host, and the absence of ability to produce adverse effects in a host, include clearance from the body, if relevant. Replication temperatures may be different from mammalian body temperature, possibly indicating low likelihood of persistence and multiplication in the host. However, temperature adaptation may occur, and this parameter alone shall not be considered sufficient to conclude on persistence and multiplication of the micro-organism in the host. Evaluation based on relevant parameters of study results and available information shall lead to an assessment of the possible effects of occupational exposure. (b) the available information on toxicity (e.g. based on biological properties, peer-reviewed literature, animal studies performed by the applicant) as described in points 2.8 and 5.5 of Part B of the Annex to Regulation (EU) No 283/2013, and Section 7 of Part B of the Annex to Regulation (EU) No 284/2013. Information available on toxicity, such as from published literature, medical information, Integrated Approach to Testing and Assessment (IATA), results of CLP calculation rules in accordance with Regulation (EC) No 1272/2008, or bridging data from similar plant protection products, may provide robust and reliable scientific indication on the toxicity of relevant chemical substances contained in the plant protection product, and be used for classification and labelling. Where an applicant provides information available on human and animal toxicity of (chemical substances present in) the plant protection product (including in vitro andex vivo data), Member States shall assess such scientific evidence provided by the applicant using a weight of evidence approach, in order to evaluate whether the possible non-submission of certain studies required in points 7.3.1 to 7.3.6 of Part B of the Annex to Regulation (EU) No 284/2013 is justified. The evaluation shall take into consideration the following principles:to avoid unnecessary animal testing, in a first instance toxicity shall be assessed on the basis of existing information as provided for in point 7.2 of Part B of the Annex to Regulation (EU) No 284/2013; toxicity studies may be necessary; further specific studies may be required taking into consideration the intended use, according to the provisions of points 2.8 and 5.5 of Part B of the Annex to Regulation (EU) No 283/2013, and of points 7.4 and 7.7 of Part B of the Annex to Regulation (EU) No 284/2013.
The evaluation of available information and possible animal studies performed by the applicant, shall take into consideration the ability of metabolites of concern, safeners, synergists, and relevant impurities to cause adverse effects on humans or animals. Evaluation based on relevant parameters of the tests shall lead to an assessment of the possible effects of non-dietary exposure, taking into account the intensity and duration of exposure under the proposed conditions of use. (c) other relevant information provided for under Part B of the Annex to Regulation (EU) No 284/2013, such as: composition of the plant protection product, nature of the plant protection product, size, design and type of packaging.
(a) on the basis of the information referred to in point 1.5.1.2 the following overall end-points shall be established for single or repeated operator, worker, bystanders and residents exposure following the intended use, as regards: observed or expected infectivity and pathogenicity of the micro-organism(s) in the plant protection product, observed or expected adverse toxicological effects of the plant protection product due to metabolites of concern safeners, synergists, and/or relevant impurities.
(b) the evaluation of the exposure of the operator shall be made for each type of application method and application equipment proposed for the use of the plant protection product as well as for the different types and sizes of packaging containers to be used, taking into account mixing, loading operations, application of the plant protection product and cleaning and routine maintenance of application equipment. Where relevant, other authorised uses of the plant protection product in the area of envisaged use, concerning the same active substance or which give rise to the same residues, shall also be taken into account. (c) the possibility of adverse effects in humans shall be assessed with regard to measured or estimated levels of human exposure as compared to the tested dose levels, as provided for under Section 7 of Part B of the Annex to Regulation (EU) No 284/2013. This risk assessment shall include consideration of e.g. mode of action, physical and chemical properties of the micro-organism and other components in the plant protection product, such as metabolites of concern, safeners, synergists and relevant impurities. (d) other relevant information provided for under Part B of the Annex to Regulation (EU) No 284/2013, such as: field of use and nature of the crop or target, method of application including handling, mixing and loading of the plant protection product, exposure reduction measures recommended, protective clothing recommendations, maximum application rate, cleaning and routine maintenance of application equipment, , taking into account also seed treatment and good occupational practice, recommendation to be followed after application, such as re-entry period and working duration, minimum (spray) application volume stated on the label, number and timing of applications, including intervals between applications, re-entry periods, necessary waiting periods or other precautions to protect humans and animals, dried residues of the plant protection products on plants and plant products after treatment, taking into account the capacity of the micro-organism to grow in situ , and the influence of factors such as temperature, UV light, pH and the presence of certain substances,further information on exposure (e.g. operator/worker/bystander/resident exposure study, further activities whereby workers are exposed).
(a) the type of packaging; (b) its dimensions and capacity; (c) the size of the opening; (d) the type of closure; (e) its strength, leak proofness and resistance to normal transport and handling; (f) its resistance to and compatibility with the contents.
(a) obtainability and suitability; (b) effectiveness; (c) ease of wearing taking into account physical stress and climatic conditions; (d) resistance to and compatibility with the plant protection product.
the intended use, including data on application and proposed pre-harvest intervals for envisaged uses or withholding periods or storage periods in the case of post-harvest uses; analytical methods as provided for under point 5.2 of Part B of the Annex to Regulation (EU) No 284/2013; the specific information on residues in/on treated plants, plant products, food and feed as provided for in Section 8 of Part B of the Annex to Regulation (EU) No 284/2013; realistic possibilities for extrapolating data from one crop to another.
non-target organisms (concerning the exposure to the micro-organism and to the metabolites of concern); humans via the environment (concerning the exposure to the metabolites of concern).
the data on the proposed good agricultural practice, including data on application; nature of the plant protection product; analytical methods, as provided for under point 4.2 of Part B of the Annex to Regulation (EU) No 283/2013, and under point 5.2 of Part B of the Annex to Regulation (EU) No 284/2013; the specific information on occurrence of the micro-organism, e.g. possible increase of microbial density in the relevant environmental compartment compared to the occurrence at the relevant highest taxonomic level in European environments, as provided for under point 7.1 of Part B of the Annex to Regulation (EU) No 283/2013, and, where relevant, Section 9 of Part B of the Annex to Regulation (EU) No 284/2013; data extrapolated from one crop to another, if considered realistic by Member States; in addition, for micro-organisms not occurring in the relevant European environments at the relevant highest taxonomic level, and which are known to be pathogenic either for plants or for other organisms, the exposure of non-target organisms through colonised host organisms shall be evaluated taking into account also the information on the population density of the micro-organism in host organisms, and the exposure of non-target organisms to colonised host organisms.
the data on the proposed good agricultural practice, including data on application; nature of the plant protection product; analytical methods, as provided for under point 4.2 of Part B of the Annex to Regulation (EU) No 283/2013, and under point 5.2 of Part B of the Annex to Regulation (EU) No 284/2013; the specific information on environmental fate and behaviour of the metabolite of concern present in the plant protection product, as provided for under point 7.2 of Part B of the Annex to Regulation (EU) No 283/2013, and, if relevant, Section 9 of Part B of the Annex to Regulation (EU) No 284/2013; if available and if submitted by the applicant to perform a qualitative exposure assessment as provided for under point 7.2.2 of Part B of the Annex to Regulation (EU) No 283/2013, on background level of the same metabolite of concern in the relevant environmental compartments; realistic possibilities of extrapolating data from one crop to another.
(a) conditions of use; (b) information on fate and behaviour as provided in Section 9 of Part B of the Annex to Regulation (EU) No 284/2013.
(a) Member States shall evaluate the risks to terrestrial vertebrates due to the micro-organism and its potential to infect and multiply in the host, taking into account the following information on the micro-organism: mode of action; other biological properties; studies on mammalian infectivity and pathogenicity; studies on avian infectivity and pathogenicity; other relevant information on terrestrial vertebrate infectivity and pathogenicity.
(b) Member States shall evaluate the risk to terrestrial vertebrates due to toxic effects of the plant protection product in accordance with relevant provisions referred to in point 1.5.2.1 of Part A.
(a) Member States shall evaluate the risks to aquatic organisms due to the micro-organism and its potential to infect and multiply the host, taking into account the following information on the micro-organism: its mode of action; other biological properties; studies on infectivity and pathogenicity to aquatic organisms and/or other existing relevant information.
(b) Member States shall evaluate the risk to aquatic organisms due to toxic effects of the plant protection product in accordance with relevant provisions referred to in point 1.5.2.2 of Part A.
(a) Member States shall evaluate the risks to bees due to the micro-organism and its potential to infect and multiply the host, taking into account the following information on the micro-organism: its mode of action; other biological properties; studies on infectivity and pathogenicity to bees and/or other existing relevant information.
(b) Member States shall evaluate the risk to bees due to toxic effects of the plant protection product, in accordance with relevant provisions referred to in point 1.5.2.3 of Part A.
(a) Member States shall evaluate the risks to arthropods other than bees due to the micro-organism and its potential to infect and multiply the host, taking into account the following information on the micro-organism: its mode of action; other biological properties; studies on infectivity and pathogenicity to honeybees and other arthropods and/or other existing relevant information.
(b) Member States shall evaluate the risk to arthropods other than bees due to toxic effects of the plant protection product in accordance with relevant provisions referred to in point 1.5.2.4 of Part A.
(a) Member States shall evaluate the risks to meso- and macroorganisms in soil due to the micro-organism and its potential to infect and multiply the host, taking into account the following information on the micro-organism: its mode of action; other biological properties; studies on infectivity and pathogenicity to meso- and macro-organisms and/or other existing relevant information.
(b) Member States shall evaluate the risk to meso- and macro-organisms in soil due to toxic effects of the plant protection product in accordance with relevant provisions referred to in point 1.5.2.5 of part A.
(a) Member States shall evaluate the risks to terrestrial plants due to the micro-organism and its potential to infect and multiply the host, taking into account the following information on the micro-organism: its mode of action; other biological properties; studies on infectivity and pathogenicity to terrestrial plants; relatedness to known plant-pathogens.
(b) Member States shall evaluate the risk to terrestrial plants due to toxic effects of the plant protection product.
the evaluation conducted in accordance with Directive 2001/18/EC as well as the relevant decision taken by the Member States has been provided by the applicant in the dossier, and an authorisation is granted in accordance with Part C of Directive 2001/18/EC under which that organism can be released into the environment, or placed on the market in a plant protection product.
recommendations for the control of or protection against target organisms, or any other effects, which are not considered to cause adverse effects on crops, plants, or plant products; or, effects which are not considered to be beneficial under those conditions.
(a) plants, plant products, foodstuffs of plant and animal origin and feeding stuffs if relevant residues occur. Residues are considered relevant if a MRL or a waiting or re-entry safety period or other such precaution is required; (b) soil, water, air and/or body fluids and tissues, in those compartments where toxicologically, ecotoxicologically or environmentally relevant residues occur.
effective and in accordance with Regulation (EU) 2016/425 of the European Parliament and of the Council Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51 ).readily obtainable by the user, feasibly usable under the claimed conditions of use of the plant protection product, taking into account climatic conditions in particular.
the surface water in or from the area of envisaged use is intended for the abstraction of drinking water; and this contamination exceeds the parameters or values established in accordance with Directive 2000/60/EC.
(i) the maximum permissible concentration laid down by Council Directive 98/83/EC Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, p. 32 ).(ii) the maximum concentration laid down when approving the active substance in accordance with Regulation (EC) No 1107/2009, based on appropriate data, in particular toxicological data, or, where that concentration has not been laid down, the concentration corresponding to one tenth of the ADI laid down when the active substance was approved Where the ADI is not available for a metabolite of concern, the default value of 0.1 μg/l applies.
(a) if the micro-organism is pathogenic to terrestrial vertebrates, (b) in case of toxic effects of the plant protection product, if the acute and short-term toxicity/exposure ratio for terrestrial vertebrates is less than 10 on the basis of LD 50 (acute dietary risk assessment) 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 no unacceptable impact occurs, directly or indirectly, after use of the plant protection product in accordance with the proposed conditions of use.
(a) if the micro-organism is pathogenic to aquatic organisms, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on aquatic organism populations would occur after use of the plant protection product in accordance with the proposed conditions of use; or (b) in case of toxic effects of the plant protection product if the: toxicity/exposure ratio for fish and Daphnia is less than 100 for acute exposure and less than 10 for long-term exposure, or algal growth inhibition/exposure ratio is less than 10,
unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on exposed species occurs, directly or indirectly, after use of the plant protection product in accordance with the proposed conditions of use.
(a) if the micro-organism is pathogenic to bees under the proposed conditions of use, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact is expected to occur to the populations of bees after use of the plant protection product in accordance with the proposed conditions of use; or (b) in case of toxic effects of the plant protection product, as defined in the decision-making principles of point 2.5.2.3 of Part A.
(a) if the micro-organism is pathogenic to arthropods other than bees, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact is expected to occur to the populations of arthropods other than bees after use of the plant protection product in accordance with the proposed conditions of use; or (b) in case of toxic effects of the plant protection product, as defined in the decision-making principles of point 2.5.2.4 of Part A, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on arthropods other than bees 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.
(a) if the micro-organism is pathogenic to meso- and macro-organisms in soil, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on soil meso- and macro-organism populations occurs after use of the plant protection product in accordance with the proposed conditions of use; or (b) in the case of toxic effects of the plant protection product, if the acute toxicity/exposure ratio for meso- and macro-organisms in soil 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 no unacceptable impact on soil meso- and macro-organism populations occur after use of the plant protection product in accordance with the proposed conditions of use.