Textual Amendments
assess the performance in terms of efficacy and phytotoxicity of the plant protection product for each use for which authorization is sought; and
identify the harzards arising, assess their significance and make a judgment as to the likely risks to humans, animals or the environment.
The first evaluation made shall be based on the best available data or estimates reflecting the realistic conditions of use of the plant protection product.
This should be followed by a repeat evaluation, taking account of potential uncertainties in the critical data and of a range of use conditions that are likely to occur and resulting in a realistic worst-case approach, to determine whether it is possible that the initial evaluation could have been significantly different.
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.
Member States shall, for the evaluation of the data and information submitted in support of applications, and without prejudice to the general principles of Section 1, implement the following principles.
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.
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;
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.
Where no suitable reference product exists, Member States shall evaluate the performance of the plant protection product to determine whether there is a consistent and defined benefit under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use.
Where the product label includes recommendations for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix, Member States shall evaluate the appropriateness of the mix and of its conditions of use.
This evaluation will take into consideration the following information:
the efficacy data provided for in Annex III;
other relevant information on the plant protection product such as nature of the preparation, dose, method of application, number and timing of applications;
all relevant information on the active substance as provided for in Annex II, including mode of action, vapour pressure, volatility and water solubility;
This evaluation will include:
the nature, frequency, level and duration of observed phytotoxic effects and the agricultural, plant health and environmental (including climatic) conditions that affect them;
the differences between main cultivars with regard to their sensitivity to phytotoxic effects;
the part of the treated crop or plant products where phytotoxic effects are observed;
the adverse impact on the yield of the treated crop or plant products in terms of quantity and/or quality;
the adverse impact on treated plants or plant products to be used for propagation, in terms of viability, germination, sprouting, rooting and establishment;
where volatile products are concerned, the adverse impact on adjacent crops.
Where the proposed use of the plant protection product aims to have an effect on vertebrates, Member States shall evaluate the mechanism by which this effect is obtained and the observed effects on the behaviour and health of the target animals; when the intended effect is to kill the target animal they shall evaluate the time necessary to obtain the death of the animal and the conditions under which death occurs.
This evaluation will take into consideration the following information:
all relevant information as provided for in Annex II and the results of the evaluation thereof, including the toxicological and metabolism studies;
all relevant information on the plant protection product as provided for in Annex III, including toxicological studies and efficacy data.
This evaluation will take into consideration the following information:
the toxicological and metabolism studies as provided for in Annex II 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;
other relevant information on the active substances such as physical and chemical properties;
the toxicological studies provided for in Annex III, including where appropriate dermal absorption studies;
other relevant information as provided for in Annex III 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;
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.
This evaluation will take into consideration the following information:
the toxicological and metabolism studies on the active substance as provided for in Annex II and the results of the evaluation thereof, including the acceptable operator exposure level;
the toxicological studies provided for in Annex III, including where appropriate dermal absorption studies;
other relevant information on the plant protection product as provided for in Annex III 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 Annex III 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.
the proposed conditions of use of the plant protection product;
the specific information on residues in or on treated plants, plant products, food and feed as provided for in Annex III and the distribution of residues between edible and non-edible parts;
the specific information on residues in or on treated plants, plant products, food and feed as provided for in Annex II and the results of the evaluation thereof;
the realistic possibilities of extrapolating data from one crop to another.
In the evaluation of the fate and distribution of the plant protection product in the environment, Member States shall have regard to all aspects of the environment, including biota, and in particular to the following:
This evaluation will take into consideration the following information:
the specific information on fate and behaviour in soil as provided for in Annex II and the results of the evaluation thereof;
other relevant information on the active substance such as:
molecular weight,
solubility in water,
octanol/water partition coefficient,
vapour pressure,
volatilization rate,
dissociation constant,
photodegradation rate and identity of breakdown products,
hydrolysis rate in relation to pH and identity of breakdown products;
all information on the plant protection product as provided for in Annex III, including the information on distribution and dissipation in soil;
where relevant, other authorized uses of plant protection products in the area of proposed use containing the same active substance or which give rise to the same residues.
As long as there is no validated Community calculation model, Member States shall base their evaluation especially on the results of mobility and persistance in soil studies as provided for in Annexes II and III.
This evaluation will also take into consideration the following information:
the specific information on fate and behaviour in soil and water as provided for in Annex II and the results of the evaluation thereof;
other relevant information on the active substance such as:
molecular weight,
solubility in water,
octanol/water partition coefficient,
vapour pressure,
volatilization rate,
hydrolysis rate in relation to pH and identity of breakdown products,
dissociation constant;
all information on the plant protection product as provided for in Annex III, including the information on distribution and dissipation in soil and water;
where relevant, other authorized uses of plant protection products in the area of envisaged use containing the same active substance or which give rise to the same residues;
where relevant, data on dissipation including transformation and sorption in the saturated zone;
where relevant, data on the procedures for drinking water abstraction and treatment in the area of envisaged use;
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.
If there is no validated Community 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 Annexes II and III.
This evaluation will also take into consideration the following information:
the specific information on fate and behaviour in soil and water as provided for in Annex II and the results of the evaluation thereof;
other relevant information on the active substance such as:
molecular weight,
solubility in water,
octanol/water partition coefficient,
vapour pressure,
volatilization rate,
hydrolysis rate in relation to pH and identity of breakdown products,
dissociation constant;
all relevant information on the plant protection product as provided for in Annex III, including the information on distribution and dissipation in soil and water;
possible routes of exposure:
drift,
run-off,
overspray,
discharge via drains,
leaching,
deposit in the atmosphere;
where relevant, other authorized uses of plant protection products in the area of envisaged use containing the same active substance or which give rise to the same residues;
where relevant, data on the procedures for drinking water abstraction and treatment in the area of envisaged use.
This evaluation will take into consideration the following information:
the specific information on fate and behaviour in soil, water and air as provided for in Annex II and the results of the evaluation thereof;
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;
all relevant information on the plant protection product as provided for in Annex III, including the information on distribution and dissipation in air.
When calculating toxicity/exposure ratios Member States shall take into consideration toxicity to the most sensitive relevant organism used in the tests.
This evaluation will take into consideration the following information:
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 Annex II and the results of the evaluation thereof;
all relevant information on the plant protection product as provided for in Annex III, including the information on effects on birds and other non-target terrestrial vertebrates;
where relevant, other authorized uses of plant protection products in the area of envisaged use containing the same active substance or which give rise to the same residues;
This evaluation will include:
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;
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;
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 , LC 50 or non-observable effects of concentration (NOEC) expressed on an active substance basis and the estimated exposure expressed in mg/kg body weight.
This evaluation will take into consideration the following information:
the specific information relating to the effects on aquatic organisms as provided for in Annex II and the results of the evaluation thereof;
other relevant information on the active substance such as:
solubility in water,
octanol/water partition coefficient,
vapour pressure,
volatilization 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;
all relevant information on the plant protection product as provided for in Annex III and in particular the effects on aquatic organisms;
where relevant, other authorized uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues;
This evaluation will include:
the fate and distribution of residues of the active substance and of relevant metabolites, breakdown and reaction products in water, sediment or fish;
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 EC 50 and the predicted short-term environmental concentration;
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;
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;
where relevant, the bioconcentration in fish and possible exposure of predators of fish, including humans;
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.
This evaluation will take into consideration the following information:
the specific information on toxicity to honeybees as provided for in Annex II and the results of the evaluation thereof;
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);
all relevant information on the plant protection product as provided for in Annex III, including the toxicity to honeybees;
where relevant, other authorized uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues;
This evaluation will include:
the ratio between the maximum application rate expressed in grammes 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;
where relevant, the effects on honeybee larvae, honeybee behaviour, colony survival and development after use of the plant protection product according to the proposed conditions of use.
This evaluation will take into consideration the following information:
the specific information on toxicity to honeybees and other beneficial arthropods as provided for in Annex II and the results of the evaluation thereof;
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);
all relevant information on the plant protection product as provided for in Annex III 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;
where relevant, other authorized uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues.
This evaluation will take into consideration the following information:
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 Annex II and the results of the evaluation thereof;
other relevant information on the active substance such as:
solubility in water,
octanol/water partition coefficient,
Kd for adsorption,
vapour pressure,
hydrolysis rate in relation to pH and identity of breakdown products,
photodegradation rate and identity of breakdown products,
DT 50 and DT 90 for degradation in the soil;
all relevant information on the plant protection product as provided for in Annex III, including the effects on earthworms and other non-target soil macro-organisms;
where relevant, other authorized uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues;
This evaluation will include:
the lethal and sublethal effects,
the predicted initial and long-term environmental concentration,
a calculation of the actue 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),
where relevant, the bioconcentration and persistence of residues in earthworms.
This evaluation will take into consideration the following information:
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 Annex II and the results of the evaluation thereof;
all relevant information on the plant protection product as provided for in Annex III, including the effects on non-target soil micro-organisms;
where relevant, other authorized uses of plant protection products in the area of proposed use, containing the same active substance or which give rise to the same residues;
all available information from biological primary screening.
Member States shall evaluate the analytical methods proposed for post-registration control and monitoring purposes, to determine:
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 will take into consideration the following information:
the data on analytical methods as provided for in Annex II and the results of the evaluation thereof;
the data on analytical methods as provided for in Annex III and in particular:
the specificity and linearity of the proposed methods,
the importance of interferences,
the precision of the proposed methods (intra-laboratory repeatability and inter-laboratory reproducibility);
the limit of detection and determination of the proposed methods for impurities.
the residues of the active substance, metabolites, breakdown or reaction products resulting from authorized uses of the plant protection product and which are of toxicological, ecotoxicological or environmental significance.
This evaluation will take into consideration the following information:
the data on analytical methods as provided for in Annex II and the results of the evaluation thereof;
the data on analytical methods as provided for in Annex III and in particular:
the specificity of the proposed methods,
the precision of the proposed methods (intra-laboratory repeatability and inter-laboratory reproducibility),
the recovery rate of the proposed methods at appropriate concentrations;
the limit of detection of the proposed methods;
the limit of determination of the proposed methods.
where a suitable FAO 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 specifications for plant protection products ’ .
This evaluation will take into consideration the following information:
the data on the physical and chemical properties of the active substance as provided for in Annex II and the results of the evaluation thereof;
the data on the physical and chemical properties of the plant protection product as provided for in Annex III.
Textual Amendments
[F1Non-extractable residues (sometimes referred to as ‘ bound ’ or ‘ non-extracted ’ residues) in plants and soils are defined as chemical species originating from pesticides used according to 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.]