Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market Text with EEA relevance
Modified by
- Commission Regulation (EU) 2015/1475of 27 August 2015amending Regulation (EU) No 284/2013 as regards the transitional measures applying to procedures concerning plant protection products(Text with EEA relevance), 32015R1475, August 28, 2015
(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) decide whether, or not, the plant protection product is to be authorised; (b) specify conditions or restrictions to be associated with any authorisation; (c) permit an evaluation of short and long-term risks for non-target species, populations, communities and processes; (d) identify relevant first aid measures as well as appropriate diagnostic and therapeutic measures to be followed in the event of poisoning in humans; (e) permit a risk assessment of acute and chronic consumer exposure, including, where relevant, a cumulative risk assessment deriving from exposure to more than one active substance; (f) permit an estimation of acute and chronic exposure to operators, workers, residents and bystanders including, where relevant, the cumulative exposure to more than one active substance; (g) permit an evaluation to be made as to the nature and extent of the risks for humans, animals (species normally fed and kept by humans or food producing animals) and of the risks for other non-target vertebrate species; (h) predict the distribution, fate, and behaviour in the environment, as well as the time courses involved; (i) identify non-target species and populations for which hazards arise because of potential exposure; (j) permit an assessment of the impact of the plant protection product on non target species; (k) identify measures necessary to minimise contamination of the environment and impact on non-target species; (l) classify the plant protection product as to hazard in accordance with Regulation (EC) No 1272/2008.
(a) they have at their disposal sufficient scientific and technical staff having the necessary education, training, technical knowledge and experience for their assigned functions; (b) they have at their disposal suitable equipment required for correct performance of the tests and measurements which they claim to be competent to carry out; that equipment is properly maintained and calibrated, where appropriate, before being put into service and thereafter according to an established programme; (c) they have at their disposal appropriate experimental fields and, where necessary glasshouses, growth cabinets or storage rooms; the environment in which the tests are undertaken shall not invalidate their results or adversely effect the required accuracy of measurement; (d) they make available to all relevant personnel operating procedures and protocols used for the trials; (e) they make available, where requested by the competent authority, prior to the commencement of a test, information on its location and on the tested plant protection products; (f) they ensure that the quality of the work performed is appropriate to its type, range, volume and intended purpose; (g) they maintain records of all observations, calculations and derived data and calibrations records and final test report as long as the product concerned is authorised in a Member State.
report to the relevant national authority all information necessary to demonstrate that they can satisfy the requirements provided for in point 3.2, permit at any time the inspections, which each Member State shall regularly organise on its territory in order to verify the compliance with point 3.2.
3.4.1. For active substances consisting of micro-organisms or viruses, tests and analyses performed to obtain data on their 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 specified at points 3.2 and 3.3. 3.4.2. 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.
the content of the technical active substances (based on the specified minimum purity) and the declared content of pure active substances and, where relevant, the corresponding content of the variant (such as salts and esters) of the active substances, the content of safeners, synergists and co-formulants, the maximum content of relevant impurities, where appropriate.
for solids, aerosols, volatile liquids (maximum boiling point 50 °C) or viscous liquids (lower limit 1 Pa s at 20 °C), as % w/w and g/kg, for other liquids/gel formulations, as % w/w and g/l, for gases, as % v/v and % w/w.
(a) adhesive (sticker); (b) antifoaming agent; (c) antifreeze; (d) binder; (e) buffer; (f) carrier; (g) deodorant; (h) dispersing agent; (i) dye; (j) emetic; (k) emulsifier; (l) fertiliser; (m) preservative; (n) odourant; (o) perfume; (p) propellant; (q) repellent; (r) solvent; (s) stabiliser; (t) thickener; (u) wetting agent; (v) miscellaneous (shall be specified by the applicant).
(a) acaricide; (b) bactericide; (c) fungicide; (d) herbicide; (e) insecticide; (f) molluscicide; (g) nematicide; (h) plant growth regulator; (i) repellent; (j) rodenticide; (k) semio-chemicals; (l) talpicide; (m) viricide; (n) other (shall be specified by the applicant).
the flowability of granular plant protection products, the pourability of suspensions, and the dustability of dustable powders following accelerated storage according to point 2.7.
(a) field use, such as agriculture, horticulture, forestry and viticulture, protected crops, amenity, weed control on non-cultivated areas; (b) home gardening; (c) house plants; (d) plant products storage practice; (e) 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 inhibitors; (h) other (shall be specified by the applicant).
effects achieved for example sprout suppression, retardation of ripening, reduction in stem length, enhanced fertilisation, types of harmful organisms controlled, plants or plant products to be protected.
g, kg, mL or L per ha, kg or L per m 3 ,g, kg, mL or L per tonne.
g, kg, mL or L per 100 m 2 , org, kg, mL or L per m 3 .
g or mL per L, or g or mL per kg.
(a) pre-harvest interval (in days) for each relevant crop; (b) re-entry period (in days) for livestock, to areas to be grazed; (c) re-entry period (in hours or days) for humans to crops, buildings or spaces treated; (d) withholding period (in days) for animal feeding stuffs and for post-harvest uses; (e) waiting period (in days), between application and handling treated products; (f) waiting period (in days), between last application and sowing or planting succeeding crops.
(a) containment of spillages; (b) decontamination of areas, vehicles and buildings; (c) disposal of damaged packaging, absorbents and other materials; (d) protection of emergency workers and residents, including bystanders; (e) first aid measures.
(a) analytical standards of the purified active substance and of the plant protection product; (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) active substance and/or variant in the plant protection product; (b) relevant impurities identified in the technical material or which may be formed during manufacture of the plant protection product or from degradation of the plant protection product during storage; (c) relevant co-formulants or components of co-formulants, where required by the national competent authorities.
(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 resulting from the physical and chemical properties tests.
in or on plants, plant products, processed food commodities, food and feed of plant and animal origin, in body fluids and tissues, in soil, in water, in air, unless the applicant shows that exposure of operators, workers, residents or bystanders is negligible.
(a) the toxicity of the plant protection product; (b) toxicity of the plant protection product relative to the active substance; (c) the time course and characteristics of the effect with full details of behavioural changes and possible gross pathological findings at post-mortem; (d) where possible the mode of toxic action; and (e) the relative hazard associated with the different routes of exposure.
(a) is a gas or liquified gas; (b) is a smoke generating plant protection product or fumigant; (c) is used with fogging/misting equipment; (d) is a vapour releasing plant protection product; (e) is supplied in an aerosol dispenser; (f) is in a form of a powder or granules containing a significant proportion of particles of diameter < 50 μm (> 1 % on a weight basis); (g) is to be applied from aircraft in cases where inhalation exposure is relevant; (h) contains an active substance with a vapour pressure > 1 × 10 –2 Pa and is to be used in enclosed spaces such as warehouses or glasshouses;(i) is to be 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 BCOP, ICE, IRE, HET-CAM), and where negative results are obtained;(3) the assessment of eye irritation using an available, in vitro test method validated for plant protection products for identification of non-irritants or irritants, and when not available;(4) an initial in vivo eye irritation study using one animal, and where no adverse effects are noted;(5) confirmatory testing using one or two additional animals.
(a) operators are people who are involved in activities relating to the application of a plant protection product, such as mixing, loading, application, or relating to cleaning and maintenance of equipment containing a plant protection product; operators may be professionals or amateurs; (b) workers are people who, as part of their employment, enter an area that has previously been treated with a plant protection product or who handle a crop that has been treated with a plant protection product; (c) bystanders are people who casually are located within or directly adjacent to an area where application of a plant protection product is in process or has taken place, but not for the purpose of working on the treated area or with the treated commodity; (d) residents are people who live, work or attend any institution near to areas that are treated with plant protection products, but not for the purpose of working on the treated area or with the treated commodity.
(a) the AOEL established in the context of approval of the active substance may be exceeded; (b) the Limit Values established for the active substance and toxicologically relevant compounds of the plant protection product in accordance with Directive 98/24/EC and Directive 2004/37/EC may be exceeded.
(a) the AOEL established in the context of approval of the active substance may be exceeded; (b) the Limit Values established for the active substance and toxicologically relevant compounds of the plant protection product in accordance with Directive 98/24/EC and Directive 2004/37/EC may be exceeded.
(a) the registration number in accordance with Article 20(3) of Regulation (EC) No 1907/2006); (b) the study summaries included in the technical dossier submitted in accordance with Article 10(a)(vi) of Regulation (EC) No 1907/2006; and (c) the safety data sheet referred to in Article 31 of Regulation (EC) No 1907/2006.
which account for more than 10 % of the amount of active substance added, which account for more than 5 % of the amount of active substance added, in at least two sequential measurements, for whose individual components (> 5 %) the maximum of formation is not yet reached at the end of the study, in soil, surface in soil, groundwater, surface water, sediment and air, following use as proposed or already occurring.
make a best-possible estimation of all relevant processes involved taking into account realistic parameters and assumptions, where possible 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 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) 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.
(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.
deposition of dust containing plant protection products by drift during sowing, indirect exposure of surface water via a sewage treatment plant (STP) after application of a plant protection product in storage rooms, and amenity use.
(a) the acute toxicity of the plant protection product cannot be predicted on the basis of the data for the active substance; or (b) the intended use includes direct application on water; (c) extrapolation on the basis of available data for a similar plant protection product is not possible.
(a) food storage in enclosed spaces; (b) non-systemic plant protection products 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.
the plant protection product contains more than one active substance, the toxicity of a plant protection product cannot be reliably predicted to be either the same or lower than the active substance tested, in accordance with the requirements set out in points 8.3.1 and 8.3.2 of Part A of the Annex to Regulation (EU) No 283/2013.
possible risks from the plant protection product for bee survival and behaviour, and impact on bees resulting from feeding on contaminated honey dew or flowers.
effects are observed in the honeybee brood feeding test (see point 8.3.1.3 of Part A of the Annex to Regulation (EU) No 283/2013), or there are indications for indirect effects such as delayed action, effects on juvenile stages, or modification of bee behaviour or other effects such as prolonged residual effects.
(a) food storage in enclosed spaces that preclude exposure; (b) wound sealing and healing treatments; (c) enclosed spaces with rodenticidal baits.
the plant protection product contains more than one active substance, the toxicity of a plant protection product cannot be reliably predicted to be either the same or lower than the active substance tested, in accordance with the requirements set out in point 8.3.2 of Part A of the Annex to Regulation (EU) No 283/2013.
(a) food storage in enclosed spaces that preclude exposure; (b) wound sealing and healing treatments; (c) enclosed spaces with rodenticidal baits.
the plant protection product contains more than one active substance, the toxicity of a plant protection product cannot be reliably predicted to be either the same or lower than the active substance tested in accordance with point 8.4.2 of Part A of the Annex to Regulation (EU) No 283/2013.
pictograms, signal words, hazard statements, and precautionary statements.
the content of the micro-organism(s) in the plant protection product and the content of the micro-organism in the material used for manufacturing of plant protection products. These must include the maximum, minimum and nominal content of the viable and non-viable material, the content of co-formulants, the content of other components (such as by-products, condensates, culture medium, etc.) and contaminating micro-organisms, derived from production process.
adhesive (sticker), antifoaming agent, antifreeze, binder, buffer, carrier, deodorant, dispersing agent, dye, emetic, emulsifier, fertiliser, odorant, perfume, preservative, propellant, repellent, safener, solvent, stabiliser, synergist, thickener, wetting agent miscellaneous (specify).
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).
The suspensibility of water dispersible products (e.g. wettable powders, water dispersible granules, suspension concentrates) must be determined and reported in accordance with CIPAC Method MT 15, MT 161 or MT 168 as appropriate. The spontaneity of dispersion of water dispersible products (e.g. suspension concentrates and water dispersible granules) must be determined and reported in accordance with CIPAC Methods MT 160 or MT 174 as appropriate.
field use, such as agriculture, horticulture, forestry and viticulture, protected crops (e.g. in glasshouses), amenity, weed control on non-cultivated areas, home gardening, house plants, stored products, other (specify).
pre-harvest interval (in days) for each relevant crop, re-entry period (in days) for livestock, to areas to be grazed, re-entry period (in hours or days) for man to crops, buildings or spaces treated, withholding period (in days) for animal feedingstuffs, waiting period (in days), between application and handling treated products.
containment of spillages, decontamination of areas, vehicles and buildings, disposal of damaged packaging, adsorbents and other materials, protection of emergency workers and bystanders, first aid measures.
| Impurities, metabolites, relevant metabolites, residues | As defined in Article 3 of 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 preparation; (ii) samples of the micro-organism as manufactured; (iii) analytical standards of the pure micro-organism; (iv) analytical standards of relevant metabolites and all other components included in the residue definition; (v) if available, samples of reference substances for the relevant impurities.
Methods, which must be described in full, must be provided for the identification and the determination of the content of the micro-organism in the preparation. In the case of a preparation containing more than one micro-organism, methods capable of identifying and determining the content of each one should be provided. Methods to establish regular control of the final product (preparation) in order to show that it does not contain other organisms than the indicated ones and to establish its uniformity. Methods to identify any contaminating micro-organisms of the preparation. Methods used to determine the storage stability and shelf life of the preparation must be provided.
the nature of the products or its use is such that a risk of occurrence of taint or odour might be expected, or other products based on the same or a closely similar active ingredient have been shown to present a risk of occurrence of taint or odour.
the nature of the plant protection product or it use could have an adverse influence on other quality aspects (for example in the case of use of plant growth regulators close to the harvest), or other products based on the same or a closely similar active ingredient have been shown to have an adverse influence on the quality.
there are indications that the use of the plant protection product could have an influence on the processes involved (for example in the case of use of plant growth regulators or fungicides close to the harvest), or other products based on the same or a closely similar active ingredient have been shown to have an adverse influence on these processes or its products.
(i) for seeds — viability, germination and vigour; (ii) for cuttings — rooting and growth rates; (iii) for runners — establishment and growth rates; (iv) for tubers — sprouting and normal growth.
the toxicity of the plant protection product, toxicity of the plant protection product relative to the micro-organism, the time course and characteristics of the effect with full details of behavioural changes and possible gross pathological findings at post-mortem, where possible the mode of toxic action, and the relative hazard associated with the different routes of exposure.
is used with fogging equipment, is an aerosol, is a powder containing a significant proportion of particles of diameter < 50 micrometre (> 1 % on a weight basis), is to be applied from aircraft in cases where inhalation exposure is relevant, is to be applied in a manner which generates a significant proportion of particles or droplets of diameter < 50 micrometre (> 1 % on a weight basis), contains a volatile component at greater than 10 %.
(a) the registration number as referred to in Article 20(3) of Regulation (EC) No 1907/2006 OJ L 396, 30.12.2006, p. 1 .(b) the study summaries included in the technical dossier as referred to in Article 10(a)(vi) of Regulation (EC) No 1907/2006, and (c) the safety data sheet as referred to in Article 31 of Regulation (EC) No 1907/2006.
specify the hazard symbols, the indications of danger, and relevant risk and safety phrases or the pictograms, signal words, relevant hazard and precautionary statements, for the protection of the environment, to be mentioned on packaging (containers), permit an evaluation of the short- and long-term risks for non-target species — populations, communities, and processes as appropriate, permit an evaluation whether special precautions are necessary for the protection of non-target species.
prediction of distribution and fate in the environment, and the time courses involved, identification of non-target species and populations at risk, and prediction of the extent of 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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