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 Text with EEA relevance
Modified by
- Commission Regulation (EU) No 1136/2014of 24 October 2014amending Regulation (EU) No 283/2013 as regards the transitional measures applying to procedures concerning plant protection products(Text with EEA relevance), 32014R1136, October 28, 2014
(a) procedures concerning the approval of an active substance or an amendment to the approval of such a substance pursuant to Article 13 of Regulation (EC) No 1107/2009 for which the dossiers provided for in Article 8(1) and (2) thereof have been submitted by 31 December 2013 ;(b) procedures concerning the renewal of approval of an active substance pursuant to Article 20 of Regulation (EC) No 1107/2009 for which the supplementary dossiers referred to in Article 9 of Commission Regulation (EU) No 1141/2010 OJ L 322, 8.12.2010, p. 10 .31 December 2013 .
(a) it is not necessary owing to the nature of the product or its proposed uses, or it is not scientifically necessary; (b) it is technically not possible to supply.
(a) permit an assessment of the risks for humans, associated with handling and use of plant protection products containing the active substance; (b) permit an assessment of the risks for human and animal health, arising from residues of the active substance and its metabolites, impurities, breakdown and reaction products remaining in water, air, food and feed; (c) predict the distribution, fate and behaviour in the environment of the active substance and metabolites, breakdown and reaction products, where they are of toxicological or environmental significance, as well as the time courses involved; (d) permit an assessment of the impact on non-target species (flora and fauna), including the impact on their behaviour, which are likely to be exposed to the active substance, its metabolites, breakdown and reaction products, where they are of toxicological or environmental significance. Impact can result from single, prolonged or repeated exposure and can be direct or indirect, reversible or irreversible; (e) evaluate the impact on biodiversity and the ecosystem; (f) identify non-target species and populations for which hazards arise because of potential exposure; (g) permit an evaluation of short and long-term risks for non-target species, populations, communities and processes; (h) classify the active substance as to hazard in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council OJ L 353, 31.12.2008, p. 1 .(i) specify the pictograms, the signal words, and relevant hazard and precautionary statements for the protection of man, non-target species and the environment, which are to be used for labelling purposes; (j) establish, where relevant, an acceptable daily intake (ADI) level for humans; (k) establish acceptable operator exposure levels (AOEL); (l) establish, where relevant, an acute reference dose, (ARfD) for humans; (m) identify relevant first aid measures as well as appropriate diagnostic and therapeutic measures to be followed in the event of poisoning in humans; (n) establish the isomeric composition and the possible metabolic conversion of the isomers, when relevant; (o) establish residues definitions appropriate for risk assessment; (p) establish residues definitions appropriate for monitoring and enforcement purposes; (q) permit a risk assessment of consumer exposure, including, where relevant, a cumulative risk assessment deriving from exposure to more than one active substance; (r) permit an estimation of the exposure to operators, workers, residents and bystanders including, where relevant, the cumulative exposure to more than one active substance; (s) establish maximum residue levels and concentration/dilution factors in accordance with Regulation (EC) No 396/2005 of the European Parliament and of the Council OJ L 70, 16.3.2005, p. 1 .(t) permit an evaluation to be made as to the nature and extent of the risks for man, animals (species normally fed and kept by humans or food producing animals) and of the risks for other non-target vertebrate species; (u) identify measures necessary to minimise contamination of the environment and impact on non-target species; (v) decide whether or not the active substance has to be considered as persistent organic pollutant (POP), persistent, bio accumulative and toxic (PBT) or very persistent and very bio accumulative (vPvB) in accordance with the criteria laid down in Annex II to Regulation (EC) No 1107/2009; (w) decide whether or not the active substance has to be considered as a candidate for substitution in accordance with the criteria laid down in Annex II to Regulation (EC) No 1107/2009; (x) decide whether or not the active substance has to be considered as a low-risk active substance in accordance with the criteria laid down in Annex II to Regulation (EC) No 1107/2009; (y) decide whether, or not, the active substance is to be approved; (z) specify conditions or restrictions to be associated with any approval.
3.2.1. For active substances consisting of micro-organisms or viruses, tests and analyses done to obtain data on the properties and safety with respect to other aspects than human health, may be conducted by official or officially recognised testing facilities or organisations which satisfy at least the requirements under points 3.2 and 3.3 of the introduction of the Annex to Commission Regulation (EU) No 284/2013 See page 85 of his Official Journal. 3.2.2. For tests and analyses made to obtain data for minor crops required under points 6.3 and 6.5.2 of Part A: the field phase may have been conducted by official or officially recognised testing facilities or organisations which satisfy at least the requirements as laid down in points 3.2 and 3.3 of the introduction of the Annex to Regulation (EU) No 284/2013; the analytical phase, if not done in accordance with the GLP requirements, shall be conducted by laboratories accredited for the relevant method in accordance with the European standard EN ISO/IEC 17025 "General requirements for the competence of testing and calibration laboratories".
3.2.3. Studies conducted before the application of this Regulation, although not fully compliant with GLP requirements or with current test methods, may be integrated into the assessment, when accepted by the competent authorities as scientifically valid, thereby removing the need for repeating animal tests, especially for carcinogenicity and reprotoxicity studies. This derogation applies to studies on all vertebrate species.
(a) chemical name in accordance with IUPAC and CA nomenclature; (b) ISO common name or proposed common name if available; (c) CAS number, EC number; (d) molecular and structural formula; (e) molar mass; (f) minimum and maximum content in g/kg; and (g) function (for example stabiliser).
(a) chemical name in accordance with IUPAC and CA nomenclature; (b) ISO common name or proposed common name, if available; (c) CAS number, EC number; (d) molecular and structural formula; (e) molar mass; and (f) maximum content in g/kg.
(a) chemical name in accordance with IUPAC and CA nomenclature; (b) ISO common name or proposed common name if available; (c) CAS number, EC number; (d) molecular and structural formula; (e) molar mass; and (f) maximum content in g/kg.
(a) Aliphatic hydrocarbon: preferably heptane (b) Aromatic hydrocarbon: preferably toluene (c) Halogenated hydrocarbon: preferably dichloromethane (d) Alcohol: preferably methanol or isopropyl alcohol (e) Ketone: preferably acetone (f) Ester: preferably ethyl acetate.
(a) acaricide; (b) bactericide; (c) fungicide; (d) herbicide; (e) insecticide; (f) molluscicide; (g) nematicide; (h) plant growth regulator; (i) repellent; (j) rodenticide; (k) semio-chemical; (l) talpicide; (m) viricide; (n) other (shall be specified by the applicant).
(a) contact action; (b) stomach action; (c) inhalation action; (d) fungitoxic action; (e) fungistatic action; (f) desiccant; (g) reproduction inhibitor; (h) other (shall be specified by the applicant).
(a) field use, such as agriculture, horticulture, forestry and viticulture; (b) protected crops; (c) amenity; (d) weed control on non-cultivated areas; (e) home gardening; (f) house plants; (g) plant products storage practice; (h) other (shall be specified by applicant).
(a) chemical name in accordance with IUPAC and CA nomenclature; (b) ISO common name or proposed common name; (c) CAS-number EC number; (d) molecular and structural formula; and (e) molar mass.
the processes, mechanisms and reactions involved, kinetic and other data concerning the rate of conversion and if known the rate limiting step, environmental and other factors effecting the rate and extent of conversion.
(a) analytical standards of the purified active substance; (b) samples of the active substance as manufactured; (c) analytical standards of relevant metabolites and all other components included in all monitoring residue definitions; (d) samples of reference substances for the relevant impurities.
(a) pure active substance in the active substance as manufactured and specified in the dossier submitted in support of approval under Regulation (EC) No 1107/2009; (b) significant and relevant impurities and additives (such as stabilisers) in the active substance as manufactured.
the accuracy of the methods shall be determined on at least two representative samples at levels appropriate to the batch data and material specification. The mean and the relative standard deviation of the recoveries shall be reported, the experimental determination of the limit of quantification (LOQ) shall not be required. However, it shall be demonstrated that the methods are sufficiently precise to analyse significant impurities at levels appropriate to the material specification and relevant impurities at a concentration equivalent to at least 20 % less than the specification limit.
(a) in soil, water, sediment, air and any additional matrices used in support of environmental fate studies; (b) in soil, water and any additional matrices used in support of efficacy studies; (c) in feed, body fluids and tissues, air and any additional matrices used in support of toxicology studies; (d) in body fluids, air and any additional matrices used in support of operator, worker, resident and bystander exposure studies; (e) in or on plants, plant products, processed food commodities, food of plant and animal origin, feed and any additional matrices used in support of residues studies; (f) in soil, water, sediment, feed and any additional matrices used in support of ecotoxicology studies; (g) in water, buffer solutions, organic solvents and any additional matrices used in the physical and chemical properties tests.
(a) the determination of all components included in the monitoring residue definition as submitted in accordance with the provisions of point 6.7.1 in order to enable Member States to determine compliance with established maximum residue levels (MRLs); they shall cover residues in or on food and feed of plant and animal origin; (b) the determination of all components included for monitoring purposes in the residue definitions for soil and water as submitted in accordance with the provisions of point 7.4.2; (c) the analysis in air of the active substance and relevant breakdown products formed during or after application, unless the applicant shows that exposure of operators, workers, residents or bystanders is negligible; (d) the analysis in body fluids and tissues for active substances and relevant metabolites.
(a) to relate the achieved exposure in toxicity studies to toxicological findings and contribute to the assessment of the relevance of these findings to human health, with a particular regard to vulnerable groups; (b) to support the design of a toxicity study (choice of species, treatment regimen, selection of dose levels) with respect to kinetics and metabolism; (c) to provide information which, in relation to the findings of toxicity studies, contributes to the design of supplementary toxicity studies as outlined in point 5.8.2; (d) to compare the metabolism of rats with the metabolism in livestock as outlined in point 6.2.4.
(a) a single oral dose (low and high dose levels); (b) an intravenous dose preferably or, if available, a single oral dose with assessment of biliary excretion (low dose level); and (c) a repeated dose.
(a) an evaluation of the rate and extent of oral absorption including maximum plasma concentration (C max ), AUC, Tmax and other appropriate parameters, such as bioavailability;(b) the potential for bioaccumulation; (c) plasma half-lives; (d) the distribution in major organs and tissues; (e) information on the distribution in blood cells; (f) the chemical structure and the quantification of metabolites in biological fluids and tissues; (g) the different metabolic pathways; (h) the route and time course of excretion of active substance and metabolites; (i) investigations whether and to what extent enterohepatic circulation takes place.
(a) the toxicity of the active substance; (b) the time course and characteristics of the effects with full details of behavioural changes, clinical signs, where evident, and possible gross pathological findings at post-mortem; (c) the possible need to consider establishing acute reference doses (such as ARfD, aAOEL aAOEL, abbreviation for "Acute AOEL". (d) where possible mode of toxic action; (e) the relative hazard associated with the different routes of exposure.
the active substance has a vapour pressure > 1 × 10 –2 Pa at 20 °C;the active substance is a powder containing a significant proportion of particles of a diameter < 50 μm ( > 1 % on weight basis); the active substance is included in products that are powders or are applied by spraying.
(1) the assessment of dermal corrosivity using a validated in vitro test method;(2) the assessment of dermal irritation using a validated in vitro test method (such as human reconstituted skin models);(3) an initial in vivo dermal irritation study using one animal, and where no adverse effects are noted;(4) confirmatory testing using one or two additional animals.
(1) the use of an in vitro dermal irritation/corrosion test to predict eye irritation/corrosion;(2) the performance of a validated or accepted in vitro eye irritation study to identify severe eye irritants/corrosives (such as Bovine Corneal Opacity and Permeability (BCOP) assay, Isolated Chicken Eye (ICE) assay, Isolated Rabbit Eye (IRE) assay, Hen's Egg Test - Chorio-Allantoic Membrane assay (HET-CAM)), and where negative results are obtained, the assessment of eye irritation using anin vitro test method for identification of non-irritants or irritants, and where not available;(3) an initial in vivo eye irritation study using one animal, and where no adverse effects are noted;(4) confirmatory testing using one or two additional animals.
(a) the relationship between dose and adverse effects; (b) toxicity of the active substance including where possible the No Observed Adverse Effect Level (NOAEL); (c) target organs, where relevant (including immune, nervous and endocrine systems); (d) the time course and characteristics of adverse effects with full details of behavioural changes and possible pathological findings at post-mortem; (e) specific adverse effects and pathological changes produced; (f) where relevant the persistence and reversibility of certain adverse effects observed, following discontinuation of dosing; (g) where possible, the mode of toxic action; (h) the relative hazard associated with the different routes of exposure; (i) relevant critical endpoints at appropriate time points for setting reference values, where necessary.
predict genotoxic potential, identify genotoxic carcinogens at an early stage, elucidate the mechanism of action of some carcinogens.
identify adverse effects resulting from long-term exposure to the active substance, identify target organs, where relevant, establish the dose-response relationship, establish the NOAEL and, if necessary, other appropriate reference points.
(a) to identify carcinogenic effects resulting from long-term exposure to the active substance; (b) to establish the species, sex, and organ specificity of tumours induced; (c) to establish the dose-response relationship; (d) where possible, to identify the maximum dose eliciting no carcinogenic effect; (e) where possible, to determine the mode of action and human relevance of any identified carcinogenic response.
(a) identification of species and strain, name of the supplier, and specific colony identification, if the supplier has more than one geographical location; (b) name of the laboratory and the dates when the study was performed; (c) description of the general conditions under which animals were maintained, including the type or brand of diet and, where possible, the amount consumed; (d) approximate age, in days, and weight of the control animals at the beginning of the study and at the time of killing or death; (e) description of the control group mortality pattern observed during or at the end of the study, and other pertinent observations (such as diseases, infections); (f) name of the laboratory and the examining scientists responsible for gathering and interpreting the pathological data from the study; (g) a statement of the nature of the tumours that may have been combined to produce any of the incidence data.
Impairment of male and female reproductive functions or capacity, for example from effects on oestrus cycle, sexual behaviour, any aspect of spermatogenesis or oogenesis, or hormonal activity or physiological response which would interfere with the capacity to fertilise, fertilisation itself or development of the fertilised ovum up to and including implantation. Harmful effects on the progeny, for example any effect interfering with normal development, both before and after birth. This includes morphological malformations such as anogenital distance, nipple retention, and functional disturbances (such as reproductive and neurological effects).
(a) identification of species and strain, name of the supplier, and specific colony identification, if the supplier has more than one geographical location; (b) name of the laboratory and the dates when the study was performed; (c) description of the general conditions under which animals were maintained, including the type or brand of diet and, where possible, the amount consumed; (d) approximate age, in days, and weight of the control animals at the beginning of the study and at the time of killing or death; (e) description of the control group mortality pattern observed during or at the end of the study, and other pertinent observations (such as diseases, infections); (f) name of the laboratory and the examining scientists responsible for gathering and interpreting the pathological data from the study.
(a) to identify direct and indirect effects on reproduction resulting from exposure to the active substance; (b) to identify any non-reproductive adverse effects occurring at lower doses than in short-term and chronic toxicity testing; (c) to establish the NOAELs for parental toxicity, reproductive outcome and pup development.
(a) to identify direct and indirect effects on embryonic and foetal development resulting from exposure to the active substance; (b) to identify any maternal toxicity; (c) to establish the relationship between observed responses and dose in both dam and offspring; (d) to establish NOAELs for maternal toxicity and pup development; (e) to provide additional information on adverse effects in pregnant as compared with non-pregnant females; (f) to provide additional information on any enhancement of general toxic effects of pregnant animals.
(a) studies on absorption, distribution, excretion and metabolism, in a second species; (b) studies on the immunotoxicological potential; (c) a targeted single dose study to derive appropriate acute reference values (ARfD, aAOEL); (d) studies on other routes of administration; (e) studies on the carcinogenic potential; (f) studies on mixture effects.
to elucidate the mode/mechanism of action, to provide sufficient evidence for relevant adverse effects.
the type, level and duration of exposure, or ingestion, and varying time periods between exposure, or ingestion, and commencement of treatment.
(a) to provide an estimate of total terminal residues in the relevant portion of crops at harvest following treatment as proposed; (b) to identify the major components of the total terminal residue; (c) to indicate the distribution of residues between relevant crops parts; (d) to quantify the major components of the residue and to show the efficiency of extraction procedures for these components; (e) to characterise and quantify conjugated and bound residues; (f) to indicate the components to be analysed for in residue quantification studies (crop residue studies).
(a) to provide an estimate of total terminal residues in edible animal products; (b) to identify the major components of the total terminal residue in edible animal products; (c) to indicate the distribution of residues between relevant edible animal products; (d) to provide evidence whether or not a residue should be classified as fat soluble; (e) to quantify the total residue in certain animal products (milk or eggs) and excreta; (f) to quantify the major components of the residue and to show the efficiency of extraction procedures for these components; (g) to characterise and quantify conjugated and bound residues; (h) to indicate the components to be analysed for in residue quantification studies (livestock feeding studies); (i) to generate data from which a decision on the need for feeding studies on food producing animals can be made.
(a) fruit (code F); (b) root crops (code R); (c) leafy crops (code L); (d) cereal/grass crops (code C/G); (e) pulses and oilseeds (code P/O); (f) miscellaneous.
(a) the site of uptake (for example via leaves or roots); (b) the formation of metabolites and breakdown products; (c) the distribution of residues between relevant parts of the crop at harvest (with particular emphasis on food and feed); (d) the metabolic pathways.
to quantify the highest likely residue levels of all components of the different residue definitions in treated crops, at harvest or outloading from store, in accordance with the proposed GAP, and to determine, where appropriate, the decline rate of plant protection product residues in plants.
substances with a water solubility < 0,01 mg/L; only simple physical operations, not involving a change in temperature of the commodity are carried out, such as washing, trimming or pressing; or the distribution of residues between pulp and inedible peel is the only effect of processing.
to determine the quantitative distribution of residues between inedible peel and pulp, to estimate peeling factors, and to allow a more realistic estimation of dietary intake of residues.
to determine the quantitative distribution of residues in the various processed commodities used as food or feed, to estimate processing factors, and to allow a more realistic estimation of dietary intake of residues.
(a) the dietary burden of a processed product in the human (such as apples) or animal diet (such as apple pomace); (b) the level of residue in the plant or plant product to be processed (normally ≥ 0,1 mg/kg); (c) the physical and chemical properties of the active substance and its relevant metabolites (such as fat-solubility in case of oil seed processing); and (d) the possibility that breakdown products of toxicological significance may occur after processing of the plant or plant product.
(a) to provide an estimate of the total terminal residues in the relevant portion of crops at harvest of rotational crops following treatment of the preceding crop as proposed; (b) to identify the major components of the total terminal residue; (c) to indicate the distribution of residues between relevant crop parts; (d) to quantify the major components of the residue; (e) to indicate additional components to be analysed for in residue quantification studies (field crop rotation studies); (f) to decide on restrictions in crop rotation; and (g) to decide on the necessity of field residue trials in rotational crops (limited field studies).
(a) to permit an evaluation of the magnitude of residues in rotational crops; (b) to decide on restrictions in crop rotation; (c) to provide information for assessing the overall significance of the residues for dietary risk assessment; and (d) to decide on the necessity of MRLs for rotational crops.
no metabolism studies on rotational crops are to be performed, or metabolism studies on rotational crops show that no residues of concern are to be expected in rotational crops.
the toxicological significance of the compounds, the amounts likely to be present, and the analytical methods proposed for post-approval control and monitoring purposes.
they shall cover a range of organic carbon content, particle size distribution and pH (preferably CaCl2) values, andwhere on the basis of other information, degradation or mobility are expected to be pH dependent, for example solubility and hydrolysis rate (see points 2.7 and 2.8), they shall cover approximately the following pH (preferably CaCl2) ranges: 5 to 6, 6 to 7 and 7 to 8.
(a) identify, if possible, the relative importance of the types of processes involved (balance between chemical and biological degradation); (b) identify the individual components present which at any time account for more than 10 % of the amount of active substance added, including, if possible, non-extractable residues; (c) identify, if possible, the individual components which in at least two sequential measurements, account for more than 5 % of the amount of active substance added; (d) identify, if possible, the individual components (> 5 %) for which at the end of the study the maximum of formation is not yet reached; (e) identify or characterise, if possible, other individual components present; (f) establish the relative proportions of the components present (mass balance); and (g) permit the soil residue of concern to which non-target species are or may be exposed, to be defined.
(a) active substance; (b) CO 2 ;(c) volatile compounds other than CO 2 ;(d) individual identified transformation products referred to in point 7.1.1; (e) extractable substances not identified; and (f) non-extractable residues in soil.
(a) they account for more than 10 % of the amount of active substance added at any time during the studies; (b) they account for more than 5 % of the amount of active substance added in at least two sequential measurements; (c) the maximum of formation is not reached at the end of the study but accounts for at least 5 % of the active substance at the final measurement; (d) all metabolites found in lysimeter studies at annual average concentrations exceed 0.1 μg/L in the leachate.
(a) at any time during the studies account for more than 10 % of the amount of active substance added; (b) in at least two sequential measurements account for more than 5 % of the amount of active substance added, if feasible; (c) at the end of the study the maximum of formation is not yet reached but accounts for at least 5 % of the active substance at the final measurement, if feasible.
(a) DegT50 lab for active substance, DegT50lab or DisT50lab for metabolites, breakdown and reaction products, in one or more soils determined at 20 °C and at a moisture content of the soil related to a pF value of 2 (suction pressure) is greater than 60 days; or(b) DegT90 lab for active substance, DegT90lab or DisT90lab for metabolites, breakdown and reaction products, in one or more soils determined at 20 °C and at a moisture content of the soil related to a pF value of 2 (suction pressure) is greater than 200 days.
(a) DegT50 lab for active substance, DegT50lab or DisT50lab for metabolites, breakdown and reaction products, determined at 10 °C and at a moisture content of the soil related to a pF value of 2 (suction pressure) is greater than 90 days; or(b) DegT90 lab for active substance, DegT90lab or DisT90lab for metabolites, breakdown and reaction products, in one or more soils, determined at 10 °C and at a moisture content of the soil related to a pF value of 2 (suction pressure) is greater than 300 days.
(a) they account for more than 10 % of the amount of active substance added, at any time during the studies; (b) they account for more than 5 % of the amount of active substance added in at least two sequential measurements; (c) the maximum of formation is not reached at the end of the study but accounts for at least 5 % of the active substance at the final measurement; (d) all metabolites found in lysimeter studies at annual average concentrations exceeding 0,1 μg/L in the leachate.
the mobility in soil, the potential for leaching to ground water, the potential distribution in soil.
the mobility in soil, the potential for leaching to ground water, the potential distribution in soil.
(a) persistence in water systems (bottom sediment and water, including suspended particles); (b) the extent to which water and sediment organisms are at risk; (c) potential for contamination of surface water and groundwater.
(a) identify the relative importance of the types of processes involved (balance between chemical and biological degradation); (b) where possible, identify the individual components present; (c) establish the relative proportions of the components present and their distribution as between water, including suspended particles, and sediment; and (d) permit the residue of concern to which non-target species are or may be exposed, to be defined.
(a) identify individual components present, which at any time account for more than 10 % of the amount of active substance added, including, where possible, non-extractable residues; (b) identify individual components present, which account for more than 5 % of the amount of active substance added in at least two sequential measurements, where possible; (c) identify individual components (> 5 %) for which at the end of the study the maximum of formation is not yet reached, where possible; (d) identify or characterise, where possible, other individual components; (e) establish, where relevant, the relative proportions of the components (mass balance); and (f) permit, where relevant, the sediment residue of concern and to which non-target species are or may be exposed, to be defined.
(a) active substance; (b) CO 2 ;(c) volatile compounds other than CO 2 ; and(d) individual identified transformation products.
(a) identify individual components present which at any time account for more than 10 % of the amount of active substance added, including, where possible, non-extractable residues; (b) identify individual components present which account for more than 5 % of the amount of active substance added in at least two sequential measurements, where possible; (c) identify individual components (> 5 %) for which at the end of the study the maximum of formation is not yet reached, where possible; (d) identify or characterise, where possible, also other individual components present; (e) establish the relative proportions of the components (mass balance); and (f) define the sediment residue of concern, to which non-target species are or may be exposed.
(a) active substance; (b) CO 2 ;(c) volatile compounds other than CO 2 ;(d) individual identified transformation products; (e) extractable substances not identified; and (f) non-extractable residues in sediment.
global warming potential (GWP); ozone depleting potential (OPD); photochemical ozone creation potential (POCP); accumulation in the troposphere; acidification potential (AP); eutrophication potential (EP).
the log Pow is greater than 3 (see point 2.7) or there are other indications of bioconcentration, and the substance is considered stable, that is to say there is less than 90 % loss of the original substance over 24 hours via hydrolysis (see point 7.2.1.1).
(a) food storage in enclosed spaces; (b) non-systemic preparations for application to soil, except granules; (c) non-systemic dipping treatments for transplanted crops and bulbs; (d) wound sealing and healing treatments; (e) non systemic rodenticidal baits; (f) use in greenhouses without bees as pollinators.
food storage in enclosed spaces that preclude exposure, wound sealing and healing treatments, enclosed spaces with rodenticidal baits.
(a) food storage in enclosed spaces that preclude exposure; (b) wound sealing and healing treatments; (c) enclosed spaces with rodenticidal baits.
pictograms, signal words, hazard statements, and precautionary statements.
is indigenous or non-indigenous at the species level to the intended area of application, is a wild type, is a spontaneous or induced mutant, has been modified, using techniques described in Part 2 of Annex IA and in Annex IB to Directive 2001/18/EC OJ L 106, 17.4.2001, p. 1 .
control of bacteria, control of fungi, control of insects, control of mites, control of molluscs, control of nematodes, control of weeds, other (must be specified).
field use, such as agriculture, horticulture, forestry, and viticulture, protected crops (e.g. in greenhouses), amenity, weed control on non-cultivated areas, home gardening, house plants, stored products, other (specify).
| Impurities, metabolites, relevant metabolites, residues | As defined in Regulation (EC) No 1107/2009 |
|---|---|
| Relevant impurities | Impurities, as defined above, that are of concern for human or animal health and/or the environment |
(i) samples of the micro-organism as manufactured; (ii) analytical standards of relevant metabolites (especially toxins) and all other components included in the residue definition; (iii) if available, samples of reference substances for the relevant impurities.
Methods for the identification of the micro-organism. Methods for providing information on possible variability of seed stock/active micro-organism. Methods to differentiate a mutant of the micro-organism from the parent wild strain. Methods for the establishment of purity of seed stock from which batches are produced and methods to control that purity. Methods to determine the content of the micro-organism in the manufactured material used for the production of formulated products and methods to show that contaminating micro-organisms are controlled to an acceptable level. Methods for the determination of relevant impurities in the manufactured material. Methods to control the absence and to quantify (with appropriate limits of determination) the possible presence of any human and mammalian pathogens. Methods to determine storage stability, shelf-life of the micro-organism, if appropriate.
the active micro-organism(s), relevant metabolites (especially toxins),
permit a decision to be made as to whether, or not, the micro-organism can be approved, specify appropriate conditions or restrictions to be associated with any approval, specify risk and safety phrases (once introduced) for the protection of man, animals and the environment to be included on packaging (containers), identify relevant first aid measures as well as appropriate diagnostic and therapeutic measures to be followed in the event of infection or another adverse effect in man.
the toxicity, pathogenicity and infectiveness of the micro-organism, the time course and characteristics of the effects with full details of behavioural changes and possible gross pathological findings at post-mortem, where possible mode of toxic action, the relative hazards associated with the different routes of exposure, and blood analyses throughout the studies in order to evaluate the clearance of the micro-organism.
the prediction of genotoxic potential, the early identification of genotoxic carcinogens, the elucidation of the mechanism of action of some carcinogens.
the relationship between dose and adverse effects, toxicity of the micro-organism including where necessary the NOAEL for toxins, target organs, where relevant, the time course and characteristics of the effects with full details of behavioural changes and possible gross pathological findings at post-mortem, specific toxic effects and pathological changes produced, where relevant the persistence and reversibility of certain toxic effects observed, following discontinuation of dosing, where possible, the mode of toxic action, and the relative hazard associated with the different routes of exposure.
permit a decision to be made as to whether or not the micro-organism can be approved, specify appropriate conditions or restrictions to be associated with any approval where relevant, set maximum residue levels, preharvest intervals to protect consumers and waiting periods, to protect workers handling the treated crops and products.
decide whether, or not, the micro-organism can be approved, specify appropriate conditions or restrictions to be associated with any approval, specify the pictograms (once introduced), signal words, and relevant hazard and precautionary statements for the protection of the environment, which are to be included on packaging (containers), predict the distribution, fate, and behaviour in the environment of the micro-organism and its metabolites as well as the time courses involved, identify measures necessary to minimise contamination of the environment and impact on non-target species.
the relevant metabolite is stable outside the micro-organism, see point 2.8, and a toxic effect of the relevant metabolite is independent of the presence of the micro-organism, and the relevant metabolite is expected to occur in the environment in concentrations considerably higher than under natural conditions.
competitiveness under the environmental conditions prevailing at and after the intended use, and population dynamics in seasonally or regionally extreme climates (particularly hot summer, cold winter and rainfall) and to agricultural practices applied after intended use.
decide whether, or not, the micro-organism can be approved, specify appropriate conditions or restrictions to be associated with any approval, permit an evaluation of short- and long-term risks for non-target species — populations, communities, and processes — as appropriate, classify the micro-organism as to biological hazard, specify the precautions necessary for the protection of non-target species, and specify the pictograms (once introduced), signal words, and relevant hazard and precautionary statements for the protection of the environment, to be mentioned on packaging (containers).
distribution and fate in the environment, and the time courses involved, identification of non-target species and populations at risk, and the extent of their potential exposure, identification of precautions necessary to avoid or minimise contamination of the environment, and for the protection of non-target species.
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