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
(a) ensure that the dossier supplied is in accordance with the requirements of the Annex to Commission Regulation (EU) No 545/2011 See page 67 of this Official Journal. ensure that the data submitted 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 544/2011 See page 1 of this Official Journal. (c) take into consideration other relevant technical or scientific information they can reasonably possess with regard to the performance of the plant protection product or to the potentially adverse effects of the plant protection product, its components or its residues.
(a) assess the performance in terms of efficacy and phytotoxicity of the plant protection product for each use for which authorisation is sought; and (b) identify the hazard arising, assess their significance and make a judgment as to the likely risks to humans, animals or the environment.
make a best possible estimation of all relevant processes involved taking into account realistic parameters and assumptions, be submitted to an analysis as referred to in B, point 1.4, be reliably validated with measurements carried out under circumstances relevant for the use of the model, be relevant to the conditions in the area of use.
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 545/2011; (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 544/2011, 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 544/2011 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 545/2011, 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 544/2011 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 545/2011, including where appropriate dermal absorption studies; (iv) other relevant information as provided for in the Annex to Regulation (EU) No 545/2011 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 544/2011 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 545/2011, 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 545/2011 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 post-harvest 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 545/2011 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 545/2011 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 544/2011 and the results of the evaluation thereof; (iv) the realistic possibilities of extrapolating data from one crop to another.
2.5.1.1. Member States shall evaluate the possibility of the plant protection product reaching the soil under the proposed conditions of use; if this possibility exists they shall estimate the rate and the route of degradation in the soil, the mobility in the soil and the change in the total concentration (extractable and non-extractable Non-extractable residues (sometimes referred to as "bound" or "non-extracted" residues) in plants and soils are defined as chemical species originating from pesticides used in accordance with good agricultural practice that cannot be extracted by methods which do not significantly change the chemical nature of these residues. These non-extractable residues are not considered to include fragments through metabolic pathways leading to natural products. This evaluation shall take into consideration the following information: (i) the specific information on fate and behaviour in soil as provided for in the Annex to Regulation (EU) No 544/2011 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 545/2011, 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.
2.5.1.2. Member States shall evaluate the possibility of the plant protection product reaching the groundwater under the proposed conditions of use; if this possibility exists, they shall estimate, using a suitable calculation model validated at EU level, the concentration of the active substance and of relevant metabolites, degradation and reaction products that could be expected in the groundwater in the area of envisaged use after use of the plant protection product in accordance with the proposed conditions of use. As long as there is no validated EU calculation model, Member States shall base their evaluation especially on the results of mobility and persistence in soil studies as provided for in the Annex to Regulation (EU) No 544/2011 and Regulation (EU) No 545/2011. This evaluation shall also take into consideration the following information: (i) the specific information on fate and behaviour in soil and water as provided for in the Annex to Regulation (EU) No 544/2011 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 545/2011, 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.
2.5.1.3. Member States shall evaluate the possibility of the plant protection product reaching surface water under the proposed conditions of use; if this possibility exists they shall estimate, using a suitable calculation model validated at EU level, the short-term and long-term predicted concentration of the active substance and of metabolites, degradation and reaction products that could be expected in the surface water in the area of envisaged use after use of the plant protection product in accordance with the proposed conditions of use. If there is no validated EU calculation model, Member States shall base their evaluation especially on the results of mobility and persistence in soil studies and the information on run-off and drift as provided for in the Annex to Regulation (EU) No 544/2011 and to Regulation (EU) No 545/2011. This evaluation shall also take into consideration the following information: (i) the specific information on fate and behaviour in soil and water as provided for in the Annex to Regulation (EU) No 544/2011 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 545/2011, 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 in 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.
2.5.1.4. Member States shall evaluate the possibility of the plant protection product being dissipated in the air under the proposed conditions of use; if this possibility exists they shall make the best possible estimation, using where appropriate a suitable, validated calculation model, of the concentration of the active substance and of relevant metabolites, degradation and reaction products that could be expected in the air after use of the plant protection product in accordance with the proposed conditions of use. This evaluation shall take into consideration the following information: (i) the specific information on fate and behaviour in soil, water and air as provided for in the Annex to Regulation (EU) No 544/2011 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 545/2011, including the information on distribution and dissipation in air.
2.5.1.5. Member States shall evaluate the procedures for destruction or decontamination of the plant protection product and its packaging.
(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 544/2011 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 545/2011, 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 544/2011 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 545/2011 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 544/2011 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 545/2011, 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 544/2011 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 545/2011 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 544/2011 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, DT50 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 545/2011, 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 544/2011 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 545/2011, 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.
2.6.1. for formulation analysis: the nature and quantity of the active substance(s) in the plant protection product and, where appropriate, any toxicologically, ecotoxicologically or environmentally significant impurities and co-formulants. This evaluation shall take into consideration the following information: (i) the data on analytical methods as provided for in the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof; (ii) the data on analytical methods as provided for in the Annex to Regulation (EU) No 545/2011 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.
2.6.2. for residue analysis: the residues of the active substance, metabolites, breakdown or reaction products resulting from authorised uses of the plant protection product and which are of toxicological, ecotoxicological or environmental significance. This evaluation shall take into consideration the following information: (i) the data on analytical methods as provided for in the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof; (ii) the data on analytical methods as provided for in the Annex to Regulation (EU) No 545/2011 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 the development and use of FAO and WHO specifications for plant protection products".
(i) the data on the physical and chemical properties of the active substance as provided for in the Annex to Regulation (EU) No 544/2011 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 545/2011.
fulfils the requirements setting out in the Commission Regulation (EU) 547/2011 See page 176 of this Official Journal. also contains the information on protection of users required by EU legislation on worker protection, specifies in particular the conditions or restrictions under which the plant protection product may or may not be used as referred to in points 1.1, 1.2, 1.3, 1.4 and 1.5 above.
(a) ensure that the proposed packaging is in accordance with the provisions of Directive 1999/45/EC; (b) ensure that: the procedures for destruction of the plant protection product, the procedures for neutralisation of the adverse effects of the product if it is accidentally dispersed, and the procedures for the decontamination and destruction of the packaging,
are in accordance with the relevant regulatory provisions.
(a) when one or more of the specific decision-making requirements referred to in points 2.1, 2.2, 2.3 or 2.7 are not fully satisfied, authorisations shall be granted only where the advantages of the use of the plant protection product under the proposed conditions of use outweigh the possible adverse effects of its use. Any restrictions on use of the 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 must not compromise proper use of the 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 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 given a time limit in which to develop and submit analytical methods that are in accordance with those criteria. The authorisation shall be reviewed on expiry of the time limit accorded to the applicant; (c) where the reproducibility of the submitted analytical methods referred to in point 2.6 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.
(a) define, where possible, preferably in close cooperation with the applicant, measures to improve the performance 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.
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. DT90 > 1 year and DT50 > 3 months), or during 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 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,
2.6.1. for formulation analysis: the method must be able to determine and to identify the active substance(s) and where appropriate any toxicologically, ecotoxicologically or environmentally significant impurities and co-formulants; 2.6.2. for residue analysis: (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 LMR × 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 formulation more 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".
(a) ensure that dossiers on microbial plant protection products supplied are in accordance with the requirements of part B of the Annex to Regulation (EU) No 545/2011, at the latest at the time of finalisation of the evaluation for the purpose of decision-making, without prejudice, where relevant, to Articles 33, 34 and 59 of Regulation (EC) No 1107/2009, ensure that the data submitted 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 referred to in part B of the Annex to Regulation (EU) No 544/2011, concerning the active substance consisting of micro-organisms (including viruses) in the plant protection product, submitted for the purpose of approval of the micro-organism concerned as active substances under Regulation (EC) No 1107/2009, and the results of the evaluation of those data, without prejudice, where relevant, to Article 33(3) and Articles 34 and 59 of Regulation (EC) No 1107/2009; (c) take into consideration other relevant technical or scientific information they can reasonably possess with regard to the performance of the plant protection product or to the potentially adverse effects of the plant protection product, its components or its metabolites/toxins.
antibiotics, which refer to substances produced by or derived from micro-organisms, and anticoccidials, which refer to substances that are active against coccidia, single cell protozoan parasites.
(a) toxicity studies; (b) biological properties of the micro-organism; (c) relationship to known plant, animal or human pathogens; (d) mode of action; (e) analytical methods.
(a) identify the hazards arising, assess their significance and make a judgement as to the likely risks to humans, animals or the environment; and (b) assess the performance in terms of efficacy and phytotoxicity/pathogenicity of the plant protection product for each use for which authorisation is sought.
(a) make a best possible estimation of all relevant processes involved taking into account realistic parameters and assumptions; (b) be submitted to an evaluation as referred to in point 1.3; (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) 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) depending on the conditions (e.g. availability of substrates for growth and metabolism) micro-organisms can switch on or off the expression of given phenotypic traits; (b) the microbial strains most adapted to the environment can survive and multiply better than the non-adapted strains. Adapted strains have a selective advantage and can form the majority within a population after a number of generations; (c) the relatively rapid multiplication of micro-organisms leads to a higher frequency of mutations. If a mutation is promoting survival in the environment, the mutant strain can become dominant; (d) the properties of viruses, in particular, can change rapidly, including their virulence.
(a) antibiosis; (b) induction of plant resistance; (c) interference with the virulence of a pathogenic target organism; (d) endophytic growth; (e) root colonisation; (f) competition of ecological niche (e.g. nutrients, habitats); (g) parasitisation; (h) invertebrate pathogenicity.
(a) The ability of a micro-organism to be pathogenic for non-target organisms (humans, animals, and other non-target organisms) must be assessed. Any relationship to known plant, animal or human pathogens that are species of the genus of the active and/or contaminating micro-organisms must be assessed. (b) Pathogenicity as well as virulence is strongly related to the host-species (e.g. determined by body temperature, physiological environment) and to the host conditions (e.g. health condition, immune status). For example, multiplication in humans depends upon the ability of the micro-organism to grow at the body temperature of the host. Some micro-organisms can only grow and be metabolically active at temperatures far below or above human body temperature, and therefore can not be pathogenic for humans. However, the route of entry of the micro-organism into the host (oral, inhalation, skin/wound) can also be the critical factor. For example, a microbial species may cause a disease following entry via skin damage, but not via the oral route.
(a) where a suitable Food and Agriculture Organisation of the United Nations (FAO) specification exists, the physical and chemical properties addressed in that specification; (b) where no suitable FAO specification exists, all relevant physical and chemical properties for the formulation referred to in the Manual on the development and use of FAO and World Health Organisation (WHO) specifications for pesticides.
(a) the choice of the crop or cultivar; (b) the agricultural and environmental (including climatic) conditions (if necessary for acceptable efficacy such data/information should also be given for the time before and after application); (c) the presence and density of the harmful organism; (d) the development stage of crop and organism; (e) the amount of the microbial plant protection product used; (f) if required on the label, the amount of adjuvant added; (g) the frequency and timing of the applications; (h) the type of application equipment; (i) the need for any special cleaning measures for the application equipment.
(a) the level, consistency and duration of the effect sought in relation to the dose in comparison with a suitable reference product or products, where they exist, and an untreated control; (b) 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.
(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 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; (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, the adverse impact on adjacent crops.
(a) all relevant information as provided for in part B of the annex to Regulation (EU) No 545/2011 and the results of the evaluation thereof, including the toxicological studies; (b) all relevant information on the plant protection product as provided for in part B of the Annex to Regulation (EU) No 545/2011, including toxicological studies and efficacy data.
(a) the specificity and linearity of the proposed methods; (b) the precision (repeatability) of the proposed methods; (c) the importance of interferences; (d) the accuracy of the proposed methods at appropriate concentrations; (e) the limit of quantification of the proposed methods.
(a) the specificity of the proposed methods; (b) the precision (repeatability) of the proposed methods; (c) the importance of interferences; (d) the quantifiability of the proposed methods.
(a) the specificity and linearity of the proposed methods; (b) the precision (repeatability) of the proposed methods; (c) the reproducibility (independent laboratory validation) of the proposed methods; (d) the importance of interferences; (e) the accuracy of the proposed methods at appropriate concentrations; (f) the limit of quantification of the proposed methods.
(a) the specificity of the proposed methods; (b) the precision (repeatability) of the proposed methods; (c) the importance of interferences; (d) the quantifiability of the proposed methods.
(a) due to the ability of micro-organisms to replicate, there is a clear difference between chemicals and micro-organisms used as plant protection products. Hazards arising are not necessarily of the same nature as those presented by chemicals, especially in relation to the capacity of micro-organisms to persist and multiply in different environments; (b) the pathogenicity of the micro-organism to humans and non-target animals, the infectiveness of the micro-organism, the ability of the micro-organism to colonise, the toxicity of metabolites/toxins as well as the toxicity of the residual growth medium, contaminants and co-formulants, are important endpoints in assessing adverse effects arising from the plant protection product; (c) colonisation, infectiveness and toxicity comprise a complex set of interactions between micro-organisms and hosts and these endpoints may not be resolved easily as independent endpoints; (d) in combining these endpoints, the most important aspects of the micro-organism that must be assessed are: ability to persist and multiply in a host (indicative of colonisation or infectivity), ability to produce non-adverse or adverse effects in a host, indicative of infectivity, pathogenicity, and/or toxicity;
(e) moreover, the complexity of the biological issues shall be taken into account in evaluating the hazards and risks presented by use of these plant protection products for human and animals. An assessment of pathogenicity and infectiveness is necessary even if the potential of exposure is deemed low; (f) for risk assessment purposes the acute toxicity studies used shall, where available, include at least two doses (e.g. one very high dose and one corresponding to the expected exposure under practical conditions).
(a) This evaluation shall take into consideration the following information: (i) the medical data and the toxicity, infectivity and pathogenicity studies as provided for in part B of the Annex to Regulation (EU) No 544/2011, and the results of the evaluation thereof. Tier 1 tests shall permit an evaluation to be made of a micro-organism with respect to its ability to persist or grow in the host and its ability to cause effects/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 non-adverse or adverse effects in a host, include fast and complete clearance from the body, no activation of the immune system, no histopathological changes, and for replication temperatures far below or far above mammalian body temperatures. These parameters can in some cases be assessed using acute studies and existing human data, and sometimes can only be assessed using repeated dose studies. Evaluation based on relevant parameters of Tier 1 tests shall lead to an assessment of the possible effects of occupational exposure, taking into account the intensity and duration of exposure including exposure due to repeated use during practical use. The toxicity of certain metabolites/toxins can only be assessed, if it has been demonstrated that the test animals are actually exposed to these metabolites/toxins; (ii) other relevant information on the micro-organism, the metabolites/toxins, residual growth medium, contaminants and co-formulants in the plant protection product, such as their biological, physical and chemical properties (e.g. survival of the micro-organism at the body temperature of humans and animals, ecological niche, behaviour of the micro-organism and/or metabolites/toxins during application); (iii) the toxicological studies provided for in part B of the Annex to Regulation (EU) No 545/2011; (iv) other relevant information provided for in part B of the Annex to Regulation (EU) No 545/2011 such as: composition of the preparation, nature of the preparation, size, design and type of packaging, field of use and nature of the crop or target, method of application including handling, loading and mixing of the plant protection 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) On the basis of the information refereed to in (a) the following overall end-points should be established for single or repeated operator exposure following the intended use: persistence or growth of the micro-organism in the host, adverse effects observed, observed or expected effects of contaminants (including contaminating micro-organisms), observed or expected effects of relevant metabolites/toxins.
If there are indications of colonisation in the host and/or if any adverse effects, indicative of toxicity/infectivity are observed, taking into account the exposure scenario (i.e. acute or repeated exposure), further testing is indicated. (c) 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 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 containing the same active substance or which give rise to the same residues may also be taken into account. It shall be taken into account that if replication of the micro-organism is expected, exposure assessment could be highly speculative. (d) The absence or presence of the potential for colonisation or the possibility of effects in operators at the tested dose levels as provided for in part B of the Annex to Regulation (EU) No 544/2011 and in part B of the Annex to Regulation (EU) No 545/2011 shall be assessed with regard to measured or estimated levels of human exposure. This risk assessment, preferably quantitative, shall include consideration of e.g. mode of action, biological, physical and chemical properties of the micro-organism and other substances in the formulation.
(a) the type of packaging; (b) its dimensions and capacity; (c) the size of the opening; (d) the type of closure; (e) its strength, leakproofness 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.
(a) the medical data and the toxicity, infectivity and pathogenicity studies provided for in part B of the Annex to Regulation (EU) No 544/2011, and the results of the evaluation thereof. Tier 1 tests shall permit an evaluation to be made of a micro-organism with respect to its ability to persist or grow in the host and its ability to cause effects/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 non-adverse or adverse effects in a host, include rapid and complete clearance from the body, no activation of the immune system, no histopathological changes, and inability to replicate at mammalian body temperatures. These parameters can in some cases be assessed using acute studies and existing human data, and sometimes can only be assessed using repeated dose studies. Evaluation based on relevant parameters of Tier 1 tests shall lead to an assessment of the possible effects of occupational exposure, taking into account the intensity and duration of exposure, including exposure due to repeated use during practical use. The toxicity of certain metabolites/toxins can only be assessed, if it has been demonstrated that the test animals are actually exposed to these metabolites/toxins; (b) other relevant information on the micro-organism, the metabolites/toxins, residual growth medium, contaminants and co-formulants in the plant protection product, such as their biological, physical and chemical properties (e.g. survival of the micro-organism at the body temperature of humans and animals, ecological niche, behaviour of the micro-organism and/or metabolites/toxins during application); (c) the toxicological studies provided for in part B of the Annex to Regulation (EU) No 545/2011; (d) other relevant information on the plant protection product as provided for in part B of the Annex to Regulation (EU) No 545/2011, 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, minimum spray application volume, composition of the preparation, excess remaining on plants and plant products after treatment, taking into account the influence of factors such as temperature, UV light, pH and the presence of certain substances, further activities whereby workers are exposed.
the stage of development of the micro-organism at which non-viable residues are produced, the development stages/life cycle of the micro-organism under typical environmental conditions; in particular, attention shall be paid to the assessment of the likelihood of survival and multiplication of the micro-organism in or on crops, food or feed, and, as a consequence, the likelihood of the production of non-viable residues, the stability of relevant non-viable residues (including the effects of factors such as temperature, UV light, pH and the presence of certain substances), any experimental study showing whether or not relevant non-viable residues are translocated in plants, data concerning the proposed good agricultural practice (including number and timing of applications, maximum application rate and minimum spray application volume, proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses) and additional data on application as provided for in part B of the Annex to Regulation (EU) No 545/2011, where relevant, other authorised uses of plant protection products in the area of envisaged use, i.e. containing the same residues, and the natural occurrence of non-viable residues on edible plant parts as a consequence of naturally occurring micro-organisms.
analytical methods for the non-viable residues, the growth curves of the micro-organism under optimal conditions, the production/formation of non-viable residues at relevant moments (e.g. at the anticipated harvest time).
the likelihood of survival, the persistence and multiplication of the micro-organism in or on crops, food or feed. The various development stages/life cycle of the micro-organism shall be addressed, information concerning its ecological niche, information on fate and behaviour in the various parts of the environment, the natural occurrence of the micro-organism (and/or a related micro-organism), data concerning the proposed good agricultural practice (including number and timing of applications, maximum application rate and minimum spray application volume, proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods in the case of post-harvest uses) and additional data on application as provided for in part B of the Annex to Regulation (EU) No 545/2011, where relevant, other authorised uses of plant protection products in the area of envisaged use, i.e. containing the same micro-organism or which result in the same residues.
the medical data and toxicity, infectivity and pathogenicity studies provided for in part B of the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof, the development stages/life cycle of the micro-organism under typical environmental conditions (e.g. in or on the treated crop), the mode of action of the micro-organism, the biological properties of the micro-organism (e.g. host specificity).
analytical methods for the viable residues, the growth curves of the micro-organism under optimal conditions, the possibilities of extrapolating data from one crop to another.
(a) the biological properties of the micro-organism; (b) the survival of the micro-organism in the environment; (c) its ecological niche; (d) the natural background level of the micro-organism, where it is indigenous; (e) information on fate and behaviour in the various parts of the environment; (f) where relevant, information on potential interference with analytical systems used for the control of the quality of drinking water as provided for in Council Directive 98/83/EC OJ L 330, 5.12.1998, p. 32 .(g) where relevant, other authorised uses of plant protection products in the area of envisaged use, e.g. containing the same active substance or which gives rise to the same residues.
(a) the biological properties of the micro-organism; (b) the survival of the micro-organism in the environment; (c) its ecological niche; (d) the natural background level of the micro-organism, where it is indigenous; (e) information on fate and behaviour in the various parts of the environment; (f) where relevant, other authorised uses of plant protection products in the area of envisaged use, e.g. containing the same active substance or which gives rise to the same residues.
(a) the survival of the micro-organism in the respective compartment; (b) its ecological niche; (c) the natural background level of the micro-organism, where it is indigenous; (d) information on fate and behaviour in the various parts of the environment; (e) where relevant, other authorised uses of the plant protection product in the area of envisaged use containing the same active substance or which give rise to the same residues.
(a) its mode of action; (b) other biological properties; (c) studies on mammalian toxicity, pathogenicity and infectivity; (d) studies on avian toxicity, pathogenicity and infectivity.
(a) studies on mammalian toxicity; (b) studies on avian toxicity; (c) information on fate and behaviour in the various parts of the environment.
(a) its mode of action; (b) other biological properties; (c) studies on toxicity, pathogenicity and infectivity.
(a) studies on toxicity to aquatic organisms; (b) information on fate and behaviour in the various parts of the environment.
(a) its mode of action; (b) other biological properties; (c) studies on toxicity, pathogenicity and infectivity.
(a) studies on toxicity to bees; (b) information on fate and behaviour in the various parts of the environment.
(a) its mode of action; (b) other biological properties; (c) studies on toxicity, pathogenicity and infectivity to honeybees and other arthropods.
(a) studies on toxicity to arthropods; (b) information on fate and behaviour in the various parts of the environment; (c) available data from biological primary screening.
(a) its mode of action; (b) other biological properties; (c) studies on earthworm toxicity, pathogenicity and infectivity.
(a) studies on earthworm toxicity; (b) information on fate and behaviour in the various parts of the environment.
(a) its mode of action; (b) other biological properties.
(a) information on fate and behaviour in the various parts of the environment; (b) all available information from biological primary screening.
(a) fulfils the requirements setting out in Regulation (EU) No 547/2011; (b) also contains the information on protection of users 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 1.1 to 1.5; (d) and that the authorisation shall mention the particulars indicated in Annexes II and III to Regulation (EU) 547/2011 and Article 10(1.2), (2.4), (2.5) and (2.6) of Directive 1999/45/EC.
(a) ensure that the proposed packaging is in accordance with the provisions of Directive 1999/45/EC; (b) ensure that: 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,
are in accordance with the relevant regulatory provisions.
(a) advantages for and compatibility with integrated control measures or organic farming; (b) facilitating strategies to minimise the risk of development of resistance; (c) reduced risk for operators and consumers; (d) reduced contamination of the environment and reduced impact on non-target species.
(a) define, where possible, preferably in close cooperation with the applicant, measures to improve the performance 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.
(a) plants, plant products, foodstuffs of plant and animal origin and feedingstuffs if toxicologically relevant residues occur. Residues are considered relevant if a maximum residue level (MRL) or a waiting or re-entry safety period or other such precaution is required; (b) soil, water, air and/or body tissues if toxicologically, ecotoxicologically or environmentally relevant residues occur.
(a) the parameters or maximum permissible concentrations laid down by Directive 98/83/EC; or (b) the parameters or maximum permissible concentrations laid down for components in the plant protection product such as relevant metabolites/toxins in accordance with Directive 2000/60/EC; or (c) the parameters for the micro-organism or the maximum concentration laid down for components in the plant protection product such as relevant metabolites/toxins when approving the micro-organism 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 1/10 of the acceptable daily intake (ADI) laid down when the micro-organism was approved in accordance with Regulation (EC) No 1107/2009,
(a) exceeds, where the surface water in or from the area of envisaged use is intended for the extraction of drinking water, concentrations above which compliance with drinking water quality established in accordance with Directive 2000/60/EC is compromised; or (b) exceeds the parameters or values for components in the plant protection product, such as relevant metabolites/toxins, established in accordance with Directive 2000/60/EC; or (c) has an impact deemed unacceptable on non-target species, including animals, in accordance with the relevant requirements provided for in point 2.8.
(a) the micro-organism is pathogenic to birds and other non-target terrestrial vertebrates; (b) in case of toxic effects due to components in the plant protection product, such as relevant metabolites/toxins, the toxicity/exposure ratio is less than 10 on the basis of the acute LD 50 value 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 effects occur — directly or indirectly — after use of the plant protection product in accordance with the proposed conditions of use.
(a) the micro-organism is pathogenic to aquatic organisms; (b) in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, the toxicity/exposure ratio is less than 100 in case of acute toxicity (EC 50 ) to daphnia and fish and 10 for long-term/chronic toxicity to algae (EC50 ), daphnia (NOEC) and fish (NOEC), unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on the viability of 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; (b) in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, the hazard quotients for oral or contact exposure of honeybees are greater than 50, unless it is clearly established through an appropriate risk assessment that under field conditions there are no unacceptable effects on honeybee larvae, honeybee behaviour, or colony survival and development after use of the plant protection product in accordance with the proposed conditions of use.
(a) the micro-organism is pathogenic to arthropods other than bees; (b) in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on those organisms after use of the plant protection product in accordance with the proposed conditions of use. Any claims for selectivity and proposals for use in integrated pest management systems shall be substantiated by appropriate data.
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