Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (repealed)

[F1 C. DECISION-MAKING U.K.

1. General principles U.K.

1. Where appropriate, Member States shall impose conditions or restrictions with the authorizations they grant. The nature and severity of these measures must be selected on the basis of, and be appropriate to, the nature and extent of the expected advantages and the risks likely to arise. U.K.

2. Member States shall ensure that, where necessary, decisions taken with respect to the granting of authorizations take account of the agricultural, plant health or environmental (including climatic) conditions in the areas of envisaged use. Such considerations may result in specific conditions and restrictions of use, and, where necessary, in authorization being granted for some but not other areas within the Member State in question. U.K.

3. Member States shall ensure that the authorized amounts, in terms of rates and number of applications, are the minimum necessary to achieve the desired effect even where higher amounts would not result in unacceptable risks to human or animal health or to the environment. The authorized amounts must be differentiated according to, and be appropriate to, the agricultural, plant health or environmental (including climatic) conditions in the various areas for which an authorization is granted. However, the rates and the number of applications may not give rise to undesirable effects such as the development of resistance. U.K.

4. Member States shall ensure that decisions respect the principles of integrated control if the product is intended to be used in conditions where these principles are relied on. U.K.

5. Since the evaluation is to be based on data concerning a limited number of representative species, Member States shall ensure that use of plant protection products does not have any long-term repercussions for the abundance and diversity of non-target species. U.K.

6. Before issuing an authorization, Member States shall ensure that the label of the product: U.K.

• 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) (1) and in Article 16 (g) and (h) of Directive 91/414/EEC.

7. Before issuing authorizations, Member States shall: U.K.

(a)

ensure that the proposed packaging is in accordance with the provisions of Directive 78/631/EEC;

(b)

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.

8. No authorization shall be granted unless all the requirements referred to in Section 2 are satisfied. However: U.K.

(a)

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;

(b)

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;

(c)

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.

9. Where an authorization has been granted according to the requirements provided for in this Annex, Member States may, by virtue of Article 4 (6): U.K.

(a)

define, where possible, preferably in close co-operation with the applicant, measures to improve the performance of the plant protection product, and/or

(b)

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.

2. Specific principles U.K.

The specific principles shall apply without prejudice to the general principles referred to in Section 1.

2.1. Efficacy U.K.

2.1.1. Where the proposed uses include recommendations for the control of or protection against organisms which are not considered to be harmful on the basis of experience acquired or scientific evidence under normal agricultural, plant health and environmental (including climatic) conditions in the areas of proposed use or where the other intended effects are not considered to be beneficial under those conditions, no authorization shall be granted for those uses. U.K.

2.1.2. The level, consistency and duration of control or protection or other intended effects must be similar to those resulting from the use of suitable reference products. If no suitable reference product exists, the plant protection product must be shown to give a defined benefit in terms of the level, consistency and duration of control or protection or other intended effects under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use. U.K.

2.1.3. Where relevant, yield response when the product is used and reduction of loss in storage must be quantitatively and/or qualitatively similar to those resulting from the use of suitable reference products. If no suitable reference product exists, the plant protection product must be shown to give a consistent and defined quantitative and/or qualitative benefit in terms of yield response and reduction of loss in storage under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use. U.K.

2.1.4. Conclusions as to the performance of the preparation must be valid for all areas of the Member State in which it is to be authorized, and must hold for all conditions under which its use is proposed, except where the proposed label specifies that the preparation is intended for use in certain specified circumstances (e.g. light infestations, particular soil types or particular growing conditions). U.K.

2.1.5. Where proposed label claims include requirements for use of the preparation with other specified plant protection products or adjuvants as a tank mix, the mixture must achieve the desired effect and comply with the principles referred to in points 2.1.1 to 2.1.4. U.K.

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.

2.2. Absence of unacceptable effects on plants or plant products U.K.

2.2.1. There must be no relevant phytotoxic effects on treated plants or plant products except where the proposed label indicates appropriate limitations of use. U.K.

2.2.2. There must be no reduction of yield at harvest due to phytotoxic effects below that which could be obtained without the use of the plant protection product, unless this reduction is compensated for by other advantages such as an enhancement of the quality of the treated plants or plant products. U.K.

2.2.3. There must be no unacceptable adverse effects on the quality of treated plants or plant products, except in the case of adverse effects on processing where proposed label claims specify that the preparation should not be applied to crops to be used for processing purposes. U.K.

2.2.4. There must be no unacceptable adverse effects on treated plants or plant products used for propagation or reproduction, such as effects on viability, germination, sprouting, rooting and establishment, except where proposed label claims specify that the preparation should not be applied to plants or plant products to be used for propagation or reproduction. U.K.

2.2.5. There must be no unacceptable impact on succeeding crops, except where proposed label claims specify that particular crops, which would be affected, should not be grown following the treated crop. U.K.

2.2.6. There must be no unacceptable impact on adjacent crops, except where proposed label claims specify that the preparation should not be applied when particular sensitive adjacent crops are present. U.K.

2.2.7. Where proposed label claims include requirements for use of the preparation with other plant protection products or adjuvants, as a tank mix, the mixture must comply with the principles referred to in points 2.2.1 to 2.2.6. U.K.

2.2.8. The proposed instructions for cleaning the application equipment must be both practical and effective so that they can be applied with ease so as to ensure the removal of residual traces of the plant protection product which could subsequently cause damage. U.K.

2.3. Impact on vertebrates to be controlled U.K.

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.

2.4. Impact on human or animal health U.K.

2.4.1. arising from the plant protection product U.K.

2.4.1.1. No authorization shall be granted if the extent of operator exposure in handling and using the plant protection product under the proposed conditions of use, including dose and application method, exceeds the AOEL. U.K.

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 (2) 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) (3) .

2.4.1.2. Where the proposed conditions of use require use of items of protective clothing and equipment, no authorization shall be granted unless those items are effective and in accordance with the relevant Community provisions and are readily obtainable by the user and unless it is feasible to use them under the circumstances of use of the plant protection product, taking into account climatic conditions in particular. U.K.

2.4.1.3. Plant protection products which because of particular properties or if mishandled or misused could lead to a high degree of risk must be subject to particular restrictions such as restrictions on the size of packaging, formulation type, distribution, use or manner of use. Moreover, plant protection products which are classified as very toxic may not be authorized for use by non-professional users. U.K.

2.4.1.4. Waiting and re-entry safety periods or other precautions must be such that the exposure of bystanders or workers exposed after the application of the plant protection product does not exceed the AOEL levels established for the active substance or toxicologically relevant compound(s) in the plant protection product nor any limit values established for those compounds in accordance with the Community provisions referred to in point 2.4.1.1. U.K.

2.4.1.5. Waiting and re-entry safety periods or other precautions must be established in such a way that no adverse impact on animals occurs. U.K.

2.4.1.6. Waiting and re-entry periods or other precautions to ensure that the AOEL levels and limit values are respected must be realistic; if necessary special precautionary measures must be prescribed. U.K.

2.4.2. arising from residues U.K.

2.4.2.1. Authorizations must ensure that residues occurring reflect the minimum quantities of the plant protection product necessary to achieve adequate control corresponding to good agricultural practice, applied in such a manner (including pre-harvest intervals or withholding periods or storage periods) that the residues at harvest, slaughter or after storage, as appropriate, are reduced to a minimum. U.K.

2.4.2.2. Where no Community maximum residue limit (MRL) (4) or provisional MRL (at national or at Community level) exists, Member States shall establish a provisional MRL in accordance with Article 4 (1) (f) of this Directive; conclusions as to the levels fixed must be valid for all circumstances which could influence the residue levels in the crop such as timing of application, application rate and frequency or manner of use. U.K.

2.4.2.3. Where the new circumstances under which the plant protection product is to be used do not correspond to those under which a provisional MRL (at national or at Community level) was established previously, Member States shall not grant an authorization for the plant protection product unless the applicant can provide evidence that its recommended use will not exceed that MRL or unless a new provisional MRL has been established by the Member State or the Commission in accordance with Article 4 (1) (f) of this Directive. U.K.

2.4.2.4. Where a Community MRL exists Member States shall not grant an authorization for the plant protection product unless the applicant can provide evidence that its recommended use will not exceed that MRL, or unless a new Community MRL has been established in accordance with the procedure provided for in the relevant Community legislation. U.K.

2.4.2.5. In the cases referred to in points 2.4.2.2 and 2.4.2.3, each application for an authorization must be accompanied by a risk assessment taking into account worst-case potential exposure of consumers in the Member State concerned on the basis of good agricultural practice. U.K.

Taking into account all registered uses, the proposed use cannot be authorized if the best possible estimate of dietary exposure exceeds the ADI.

2.4.2.6. Where the nature of residues is affected during processing, a separate risk assessment may need to be carried out under the conditions provided for in point 2.4.2.5. U.K.

2.4.2.7. Where the treated plants or plant products are intended to be fed to animals, residues occurring shall not have an adverse effect on animal health. U.K.

2.5. Influence on the environment U.K.

2.5.1. Fate and distribution in the environment U.K.

2.5.1.1. No authorization shall be granted if the active substance and, where they are of significance from the toxicological, ecotoxicological or environmental point of view, metabolites and breakdown or reaction products, after use of the plant protection product under the proposed conditions of use: U.K.

• 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.

2.5.1.2. No authorization shall be granted if the concentration of the active substance or of relevant metabolites, degradation or reaction products in groundwater, may be expected to exceed, as a result of use of the plant protection product under the proposed conditions of use, the lower of the following limit values: U.K.

(i)

the maximum permissible concentration laid down by Council Directive 80/778/EEC (5) of 15 July 1980 relating to the quality of water intended for human consumption, or

(ii)

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.

2.5.1.3. No authorization shall be granted if the concentration of the active substance or of relevant metabolites, breakdown or reaction products to be expected after use of the plant protection product under the proposed conditions of use in surface water: U.K.

• 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 (6) , 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.

2.5.1.4. No authorization shall be granted if the airborne concentration of the active substance under the proposed conditions of use is such that either the AOEL or the limit values for operators, bystanders or workers as referred to in Part C, point 2.4.1, are exceeded. U.K.

2.5.2. Impact on non-target species U.K.

2.5.2.1. Where there is a possibility of birds and other non-target terrestrial vertebrates being exposed, no authorization shall be granted if: U.K.

• 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.

2.5.2.2. Where there is a possibility of aquatic organisms being exposed, no authorization shall be granted if: U.K.

• 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.

2.5.2.3. Where there is a possibility of honeybees being exposed, no authorization shall be granted if the hazard quotients for oral or contact exposure of honeybees are greater than 50, unless it is clearly established through an appropriate risk assessment that under field conditions there are no unacceptable effects on honeybee larvae, honeybee behaviour, or colony survival and development after use of the plant protection product according to the proposed conditions of use. U.K.

2.5.2.4. Where there is a possibility of beneficial arthropods other than honeybees being exposed, no authorization shall be granted if more than 30 % of the test organisms are affected in lethal or sublethal laboratory tests conducted at the maximum proposed application rate, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on those organisms after use of the plant protection product according to the proposed conditions of use. Any claims for selectivity and proposals for use in integrated pest management systems shall be substantiated by appropriate data. U.K.

2.5.2.5. Where there is a possibility of earthworms being exposed, no authorization shall be granted if the acute toxicity/exposure ratio for earthworms is less than 10 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 earthworm populations are not at risk after use of the plant protection product according to the proposed conditions of use. U.K.

2.5.2.6. Where there is a possibility of non-target soil micro-organisms being exposed, no authorization shall be granted if the nitrogen or carbon mineralization processes in laboratory studies are affected by more than 25 % after 100 days, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on microbial activity after use of the plant protection product according to the proposed conditions of use, taking account of the ability of micro-organisms to multiply. U.K.

2.6. Analytical methods U.K.

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:

2.6.1. for formulation analysis: U.K.

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;

2.6.2. for residue analysis: U.K.

(i)

the method must be able to determine and confirm residues of toxicological, ecotoxicological or environmental significance;

(ii)

the mean recovery rates should be between 70 % and 110 % with a relative standard deviation of ≤ 20 %;

(iii)

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;

(iv)

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;

(v)

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

2.7. Physical and chemical properties U.K.

2.7.1. Where an appropriate FAO specification exists, that specification must be met. U.K.

2.7.2. Where no appropriate FAO specification exists, the physical and chemical properties of the product must meet the following requirements U.K.

(a)

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

(b)

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 ’ .

2.7.3. Where the proposed label claims include requirements or recommendations for use of the preparation with other plant protection products or adjuvants as a tank mix and/or where the proposed label includes indications on the compatibility of the preparation with other plant protection products as a tank mix, those products or adjuvants must be physically and chemically compatible in the tank mix.] U.K.

Textual Amendments

F1 Substituted by Council Directive 97/57/EC of 22 September 1997 establishing Annex VI to Directive 91/414/EEC concerning the placing of plant protection products on the market.

(1)

[F1 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 ).

(2)

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 ).

(3)

OJ L 196, 26. 7. 1990, p. 1 . Directive as amended by Directive 97/42/EC ( OJ L 179, 8. 7. 1997, p. 4 ).

(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 .

(5)

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 ).

(6)

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 ).]

Textual Amendments

F1 Substituted by Council Directive 97/57/EC of 22 September 1997 establishing Annex VI to Directive 91/414/EEC concerning the placing of plant protection products on the market.