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- Point in Time (01/06/2005)
- Original (As adopted by EU)
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ensure that the dossier supplied is in accordance with the requirements of Annex III, at the latest at the time of finalization of the evaluation for the purpose of decision-making, without prejudice, where relevant, to the provisions of Article 13 (1) (a), (4) and (6) of this Directive,
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;
take into account the Annex II data concerning the active substance in the plant protection product, submitted for the purpose of inclusion of the active substance concerned in Annex I, and the results of the evaluation of those data, without prejudice, where relevant, to the provisions of Article 13 (1) (b), (2), (3) and (6) of this Directive;
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.
Taking account of justifications provided and with the benefit of any subsequent clarifications, Member States shall reject applications for which the data gaps are such that it is not possible to finalize the evaluation and to make a reliable decision for at least one of the proposed uses.
Member States shall ITALICly come to a reasoned decision within 12 months of receiving a technically complete dossier. A technically complete dossier is one that satisfies all the requirements of Annex III.
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.
fulfils the requirements of Article 16 of this Directive,
also contains the information on protection of users required by Community 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, 2, 3, 4 and 5 above.
The authorization shall mention the particulars indicated in Article 6 (2) (g) and (h), (3) and (4) of Council Directive 78/631/EEC of 26 June 1978 on the approximation of the laws of the Member States relating to the classification, packaging and labelling of dangerous preparations (pesticides) (2) and in Article 16 (g) and (h) of Directive 91/414/EEC.
ensure that the proposed packaging is in accordance with the provisions of Directive 78/631/EEC;
ensure that:
the procedures for destruction of the plant protection product,
the procedures for neutralization of the adverse effects of the product if it is accidentally dispersed, and
the procedures for the decontamination and destruction of the packagings,
are in accordance with the relevant regulatory provisions.
when one or more of the specific decision-making requirements referred to in Part C, points 2.1, 2.2, 2.3 or 2.7, are not fully satisfied, authorizations shall be granted only where the advantages of the use of the plant protection product under the proposed conditions of use outweight 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 minimize 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;
where the criteria referred to in Part C, point 2.6, are not fully satisfied because of limitations in current analytical science and technology, authorization 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 the criteria referred to above. The authorization will be reviewed on expiry of the time limit accorded to the applicant;
where the reproducibility of the submitted analytical methods referred to in Part C, point 2.6, has only been verified in two laboratories, an authorization shall be granted for one year to permit the applicant to demonstrate the reproducibility of those methods in accordance with agreed criteria.
define, where possible, preferably in close co-operation with the applicant, measures to improve the performance of the plant protection product, and/or
define, where possible, in close co-operation with the applicant, measures to reduce further the exposure that could occur during and after use of the plant protection product.
Member States shall inform applicants of any measures identified under (a) or (b) and shall invite applicants to provide any supplementary data and information necessary to demonstrate peformance or potential risks arising under the changed conditions.
The specific principles shall apply without prejudice to the general principles referred to in Section 1.
Where proposed label claims include recommendations for use of the preparation with specified plant protection products or adjuvants as a tank mix, Member States shall not accept the recommendations unless they are justified.
An authorization for a plant protection product intended to eliminate vertebrates shall be granted only when:
death is synchronous with the extinction of consciousness, or
death occurs immediately, or
vital functions are reduced gradually without signs of obvious suffering.
For repellant products, the intended effect shall be obtained without unnecessary suffering and pain for the target animals.
Moreover, the conditions of the authorization shall be in compliance with the limit value established for the active substance and/or toxicologically relevant compound(s) of the product in accordance with Council Directive 80/1107/EEC of 27 November 1980 on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work (3) and in accordance with Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work (sixth special directive within the meaning of Article 16 (2) of Directive 89/39/EEC) (4) .
Taking into account all registered uses, the proposed use cannot be authorized if the best possible estimate of dietary exposure exceeds the ADI.
during tests in the field, persist in soil for more than one year (i.e. DT 90 > 1 year and DT 50 > 3 months), or
during laboratory tests, form non-extractable residues in amounts exceeding 70 % of the initial dose after 100 days with a mineralization rate of less than 5 % in 100 days,
unless it is scientifically demonstrated that under field conditions there is no accumulation in soil at such levels that unacceptable residues in succeeding crops occur and/or that unacceptable phytotoxic effects on succeeding crops occur and/or that there is an unacceptable impact on the environment, according to the relevant requirements provided for in points 2.5.1.2, 2.5.1.3, 2.5.1.4 and 2.5.2.
the maximum permissible concentration laid down by Council Directive 80/778/EEC (6) of 15 July 1980 relating to the quality of water intended for human consumption, or
the maximum concentration laid down by the Commission when including the active substance in Annex I, 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 included in Annex I
unless it is scientifically demonstrated that under relevant field conditions the lower concentration is not exceeded.
exceeds, where the surface water in or from the area of envisaged use is intended for the abstraction of drinking water, the values fixed by Council Directive 75/440/EEC of 16 June 1975 concerning the quality required of surface water intended for the abstraction of drinking water in the Member States (7) , or
has an impact deemed unacceptable on non-target species, including animals, according to the relevant requirements provided for in point 2.5.2.
The proposed instructions for use of the plant protection product, including procedures for cleaning application equipment, must be such that the likelihood of accidental contamination of surface water is reduced to a minimum.
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 according to 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 according to 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 1 000 for plant protection products containing active substances which are readily biodegradable or greater than 100 for those which are not readily biodegradable,
unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on the viability of exposed species (predators) occurs — directly or indirectly — after use of the plant protection product according to the proposed conditions of use.
The methods proposed must reflect the state of the art. The following criteria must be met in order to permit validation of the analytical methods proposed for post-registration control and monitoring purposes:
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;
the method must be able to determine and confirm residues of toxicological, ecotoxicological or environmental significance;
the mean recovery rates should be between 70 % and 110 % with a relative standard deviation of ≤ 20 %;
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 are determined by interpolation from a log-log graph;
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;
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 Community 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 |
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 o 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 |
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 specifications for plant protection products ’ .
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.
OJ L 206, 29. 7. 1978, p. 13 . Directive as last amended by Directive 92/32/EEC ( OJ L 154, 5. 6. 1992, p. 1 ).
OJ L 327, 3. 12. 1980, p. 8 . Directive as last amended by Directive 88/642/EEC ( OJ L 356, 24. 12. 1988, p. 74 ).
OJ L 196, 26. 7. 1990, p. 1 . Directive as amended by Directive 97/42/EC ( OJ L 179, 8. 7. 1997, p. 4 ).
A Community MRL will mean an MRL established pursuant to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables a , Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals a , Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin a , Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal orgin a , Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables a or Council Directive 91/132/EEC of 4 March 1991 amending Directive 74/63/EEC on undesirable substances and products in feedingstuffs a .
OJ L 229, 30. 8. 1980, p. 11 . Directive as last amended by Directive 91/692/EEC ( OJ L 377, 31. 12. 1991, p. 48 ).
OJ No L 194, 25. 7. 1975, p. 34 . Directive as last amended by Directive 91/692/EEC ( OJ No L 377, 31. 12. 1991, p. 48 ).]
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