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Version Superseded: 01/08/2011
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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 (1) 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) (2) .
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 (4) 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 (5) , 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
[F1 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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