Proposal for a Council Directive establishing Annex VI to Directive 91/414/EEC concerning the placing of plant protection products on the market
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 10. 06. 1997 COM(97) 284 final Proposal for a COUNCIL DIRECTIVE establishing Annex VI to Directive 91/414/EEC concerning the placing of plant protection products on the market (presented by the Commission) EXPLANATORY MEMORANDUM 1. Background Council Directive 94/43/EC1 of 27 July 1994 established Annex VI to Council Directive 91/414/EEC2 of 15 July 1991 concerning the placing-of plant protection products on the market. Annex VI contains the uniform principles to be used by Member States when authorising plant protection products containing active substances included in Annex I of Directive 91/414/EEC. On 18 June 1996 the European Court of Justice annulled Directive 94/43/EC following action by the Parliament against the Council on the basis that it modified the scope of the basic Directive 91/414/EEC without following the legislative procedure prescribed by the Treaty, which calls for Parliament to be consulted (case C-303/94). The Court found that Directive 94/43/EC modified the scope of the basic directive by: - establishing uniform principles that did not cover all the requirements provided in Article 4 of the basic directive. Specifically Article 4 requires that plant protection products must have no unacceptable influence on the environment including inter refers only to groundwater intended for the production of drinking water and not all groundwater. alia groundwater whilst Directive 94/43/EC 1 OJ No L227, 1. 9. 1994, p. 31 2 OJ No L230, 19. 8. 1991, p. l - allowing the issue of conditional authorizations for plant protection products whose foreseeable concentrations in groundwater intended for the production of drinking water exceeds the maximum permissable concentration laid down in a reference measure (in this case Council Directive 80/778/EEC3 of 15 July 1980 relating to the quality of water intended for human consumption). The need to re-establish uniform principles is urgent given that the first active substances could be included in Annex I during Spring 1997. Without uniform principles some of the main provisions of Directive 91/414/EEC, including the high level of protection of human and animal health and the environment required and the mutual recognition of authorizations between Member States, cannot be operated. 2. Aim and provisions of the proposal The current proposal intends to establish a new text for Annex VI to Directive 91/414/EEC. In this proposal the provisions relating to groundwater are amended and further restricted as it was these provisions which were contested by Parliament and found by the Court not to satisfy the basic provisions of Article 4 of Directive 91/414/EEC. The other provisions have not been changed as they were not contested, were agreed in Council only very recently and no elements arose indicating that they would not satisfy the requirements of the basic directive. The following specific changes are proposed and further explained in more detail : 2. 1. EVALUATION The proposed amendments in section B, Evaluation, 2. Specific principles, paragraph 2. 5. 1. 2: ensure that the evaluation covers now all groundwater, and not only groundwater intended for drinking water production. clarify the use of monitoring data, pending the adoption of more precise provisions in the framework of the new water Directives under preparation. 2. 2. DECISION MAKING The following regime is proposed in section c, Decision making, 2. Specific principles, paragraph 2. 5. 1. 2 : 3 OJ No L229, 30. 8. 1980, p. 11. for all plant protection products, containing either new or existing active substances the following requirement is applied : no authorization may be granted if, as a result of the use of the plant protection product under the conditions of use (i. e. the conditions of use that are proposed to be applied after the authorization will have been granted), the expected concentration in groundwater exceeds the lower of the two following limit proposed values : (i) the maximum concentration laid down in Directive 80/778/EEC related to the quality of water intended for human consumption (the so called "drinking water directive"). This standard has been taken for the reason that it is precise and that it is considered as a high level quality standard, and at this time no such precise standard is provided for in the Community legislation for groundwater itself ; (ii) a maximum concentration which is based on the toxicological and, where appropriate, ecotoxicological information examined by the Commission and the Member States when the active substance is included in Annex I : this maximum concentration is either laid down explicitly by the Commission when the active substance is included in Annex I, or when such concentration has not been laid down explicitly by the Commission, it is the concentration extrapolated from the ADI (acceptable daily intake) on the basis that 10 % of the daily intake is taking place via the drinking water. The ADI is established during the examination of the above mentioned toxicological information, before the active substance is included in Annex I. The expected concentrations in groundwater are estimated by using the models referred to in part B. It is however acknowledged that the models currently used do not always enable a precise estimation and due to the included safety factors may overestimate the concentrations effectively found. Therefore the provisions also provide for the possibility that authorizations can be granted when it is scientifically demonstrated, for example with field experiments or appropriate monitoring data, that the lower of the above mentioned limit values is not exceeded under relevant field conditions. Monitoring data should be '-. "" -'-ted and interpreted in a consistent scientific way. m ey should normally cover a sufficient period of time (not exceeding one year) to take into account possible fluctuations. Monitoring rules and procedures to be followed will be those laid down in existing Directives concerning the protection of water. In the cases where particular concerns arise specific action should be considered. In that case the provisions of Directive 91/414/EEC apply which means that such information has to be sent to all Member States and the Commission who has to refer such information to the Standing Committee on Plant Health. active substances in situations The regime also applies for plant protection products containing certain existing where, due to use of the product or other products containing that active substance in the past under previous national regulatory requirements, in practice the lower of the limit values mentioned under 2. 2. a. (i) and (ii) is already exceeded in groundwater at least in certain areas or regions of the Member State concerned. This situation is also covered by the proposed text under C 2. 5. 1. 2: an authorization may only be granted for such products, if the new proposed conditions of use are restricted in such a way that the use under such conditions will not lead to exceedance of the lower of the limit values mentioned under 2. 2 (i) and 2. 2 (ii) above, without taking into account the already existing concentrations in groundwater. Therefore, the already existing concentrations in groundwater resulting from previous use will not as such prevent these plant protection products from an authorization under this Directive. 3. Evaluation of the proposal in the light of the principle of subsidiarity. 3. 1. What are the objectives of the proposed action? The proposed action establishes Annex VI to Council Directive 91/414/EEC concerning the placing of plant protection products on the market. 3. 2. Does the envisaged action belong to an exclusive Community competence or is the competence shared between the Member States and the Community? The proposed action belongs to an exclusive Community competence. 3. 3. What is the Community dimension of the problem? Whenever Member States grant authorizations for plant protection products, containing an active substance included in Annex I to the directive, they must use the uniform principles established in Annex VI of Directive 91/414/EEC to ensure harmonised decision making between Member States. Without such harmonised decision making fundamental parts of Directive 91/414/EEC such as mutual recognition of authorizations between Member States cannot operate. Member States may be required to use Annex VI as early as Spring 1997 when it is expected that the first active substances will be included in Annex I. 3. 4. What is the most efficient solution in the light of the possibilities of. the Community and the Member States? The most efficient solution is to establish Annex VI of Directive 91/414/EEC as soon as possible and as matter of urgency. 3. 5. What is the added value of the envisaged action, and what are the consequences of non action? Action is required to ensure the full operation of Directive 91/414/EEC. Non action would prevent the operation of the most important provisions of Directive 91/414/EEC. 3. 6. What are the means for Community action? The proposed directive to establish Annex VI of Directive 91/414/EEC. 3. 7. Is harmonisation necessary or is it possible to adopt a framework directive containing general principles leaving the application to the Member States? The harmonization is necessary and must be as precise as possible. 4. Financial implications The proposal is expected to have a negligible impact on the Community budget. 5. Impact on industry, including SMEs See separate evaluation. COUNCIL DIRECTIVE / /EC of establishing Annex VI to Directive 91/414/EEC concerning the placing of plant protection products on tr on products on the market THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91 /414/EECf1) of 1 5 July 1991 concerning the placing of plant protection products on the market, and in particular Article 18(1) thereof, Having regard to the proposal from the Commission, Whereas by the judgement of the European Court of Justice of 18 June 1996(2) Council Directive 94/43/EC(3) of 27 July 1 9 9 4, establishing Annex VI to Directive 91/414/EEC, was annulled; Whereas Annex VI to Directive 91/414/EEC lays down uniform principles aiming to ensure that the Member States, in deciding on authorizations for plant protection products, apply the requirements of Article 4(1 )(b), (c), (d) and (e) of that Directive in an equivalent manner and at the high level of protection of human and animal health and the environment sought by the Directive; Whereas it is therefore necessary to lay down detailed principles concerning the evaluation of information on plant protection products supplied by applicants and the decision to be made on authorization on the basis of the results of that evaluation; Whereas such principles have to be laid down for each of the different requirements provided for in Article 4 (1) (b), (c), (d) and (e); Whereas, initially, it is possible to lay down at this stage uniform principles for chemical plant protection products only; whereas therefore it remains for the uniform principles for products containing micro-organisms to be laid down in accordance w i th the same procedure as provided for in Article 18(1) of the Directive 91/414/EEC; whereas such approach is in line w i th Directive 91/414/EEC, and in particular article 23 (2) thereof; Whereas in particular for all plant protection products a high level of protection for all groundwater must be satisfied under the conditions of use which will be laid d o wn in the authorization; whereas therefore it must be provided that plant protection products may only be authorized w h en it is adequately demonstrated that their use in accordance w i th the conditions to be laid d o wn in the authorization will not lead to concentrations of the active substance or of relevant metabolites, d e g r ^ d M ^" ~r reaction products in groundwater which C) OJ No L 2 3 0, 1 9. 8. 1 9 9 1, p. 1. Directive as last amended by Directive 96/68/EC (OJ No L 2 7 7, 3 0. 1 0. 1 9 9 6, p. 25). (2) Case C - 3 0 3 / 94 (3) OJ No L 2 2 7, 1. 9. 1994, p. 3 1. exceed the lower of the limit values for groundwater referred to in this Directive; whereas this applies as well for plant protection products containing active substances, already on the market t wo years after notification of Directive 91/414/EEC, which means that for such products an authorization can only be granted where it is adequately demonstrated that, under the new conditions of use which will be laid down in the authorization, the expected concentrations resulting exclusively from the new use will not exceed the lower of the limit values referred to in this Directive; Whereas the provisions of this Directive concerning the protection of water, including the provisions related to monitoring, are without prejudice to Member States' obligations under the Directives concerning the protection of water, and in particular Directives 75/440/EEC (4), 80/68/EEC (5) and 80/778/EEC (6); Whereas a review of the abovementioned Directives is in progress, and where necessary wil have to be followed by an adaptation of the present Directive; Whereas a short implementation period is justified given that in the light of the decision of the European Court of Justice of 18 June 1996 only those provisions concerning groundwater have been reviewed; HAS ADOPTED THIS DIRECTIVE: Article 1 Annex VI to Directive 91/414/EEC is hereby established as set out in the Annex to this Directive. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply w i th this Directive not later than 1 October 1 9 9 7. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid d o wn by the Member States. Article 3 This Directive shall enter into force on the date of its publication in the Official Journal of the European Communities. (4) 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 (OJ No L 194, 2 5. 7. 1 9 7 5. p. 2 6. Directive as last amended by Directive 91/692/EEC (OJ No L 3 7 7, 3 1. 1 2. 1 9 9 1, p. 4 8 ). (5) Council Directive 80/68/EEC of 17 December 1 9 79 on the protection of groundwater against pollution caused by certain dangerous substances (OJ No L 2 0, 2 6. 1. 1 9 8 0, p. 43). Directive as last amended by Directive 91/692/EEC (OJ No L 3 7 7, 3 1. 1 2. 9 1, p. 4 8 ). (6) Council Directive 80/778/EEC of 15 July 1 9 80 relating to the quality of water intended for human consumption (OJ No L 2 2 9, 3 0. 8. 1 9 8 0, p. 11). Directive as last amended by Directive 91/692/EEC (OJ No L 3 7 7, 3 1. 1 2. 1 9 9 1, p. 4 8 ). This Directive is addressed to the Member States. Article 4 Done at Brussels, For the Council, The Presidentt 8 "ANNEX VI ANNEX UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORIZATION OF PLANT PROTECTION PRODUCTS CONTENTS A. INTRODUCTION B. EVALUATION 1. 2. 2. 1. 2. 2. 2. 3. 2. 4. 2. 5. 2. 6. 2. 7. General principles Specific principles Efficacy Absence of unacceptable effects on plants or plant products Impact on vertebrates to be controlled Impact on human or animal health Influence on the environment Analytical methods Physical and chemical properties DECISION-MAKING 1. 2. 2. 1. 2. 2. 2. 3. 2. 4. 2. 5. 2. 6. 2. 7. General principles Specific principles Efficacy Absence of unacceptable effects on plants or plant products Impact on vertebrates to be controlled Impact on human or animal health Influence on the environment Analytical methods Physical and chemical properties INTRODUCTION 1. The principles developed in this Annex aim to ensure that evaluations and decisions w i th regard to authorization of plant protection products, provided they are chemical preparations, result in the implementation of the requirements of Article 4(1 )(b), (c), (d) and (e) of this Directive by all the Member States at the high level of protection of human and animal health and the environment. 2. In evaluating applications and granting authorizations Member States shall: (a) - ensure that the dossier supplied is in accordance w i th 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; (b) 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; (c) take into consideration other relevant technical or scientific information they can reasonably possess w i th 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. 10 3. Where in the specific principles on evaluation reference is made to Annex II data, this shall be understood as being the data referred to in point 2(b). 4. Where the data and information provided are sufficient to permit completion of the evaluation for one of the proposed uses, applications must be evaluated and a decision made for the proposed use. Taking account of justifications provided and w i th 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. 5. During the process of evaluation and decision-making, Member States shall cooperate w i th the applicants in order to resolve any questions on the dossier quickly or to identify at an early stage any additional studies necessary for a proper evaluation of the dossier, or to amend any proposed conditions for the use of the plant protection product or to modify its nature or its composition in order to ensure full satisfaction of the requirements of this Annex or of this Directive. Member States shall normally 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. 6. The judgments made by the competent authorities of the Member States during the evaluation and decision-making process must be based on scientific principles, preferably recognized at international level (for example, by the EPPO), and be made w i th the benefit of expert advice. 1 1 B. EVALUATION 1. General principles 1. Having regard to current scientific and technical knowledge, Member States shall evaluate the information referred to in Part A, point 2, and in particular: (a) assess the performance in terms of efficacy and phytotoxicity of the plant protection product for each use for which authorization is sought, and (b) identify the hazards arising, assess their significance and make a judgment as to the likely risks to humans, animals or the environment. 2. In accordance w i th the terms of Article 4 of this Directive, which inter alia specifies that Member States shall have regard to all normal conditions under which the plant protection product may be used, and to the consequences of its use, Member States shall ensure that evaluations carried out have regard to the proposed practical conditions of use and in particular to the purpose of use, the dose, the manner, frequency and timing of applications, and the nature and composition of the preparation. Whenever possible Member States shall also take into account the principles of integrated control. 3. In the evaluation of applications submitted, Member States shall have regard to the agricultural, plant health or environmental (including climatic) conditions in the areas of use. 4. In interpreting the results of evaluations, Member States shall take into consideration possible elements of uncertainty in the information obtained during the evaluation, in order to ensure that the chances of failing to detect adverse effects or of under-estimating their importance are reduced to a minimum. The decision-making process shall be examined to identify critical decision points or items of data for which uncertainties could lead to a false classification of risk. 12 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. 5. Where specific principles of Section 2 provide for the use of calculation models in the evaluation of a plant protection product, those models shall: - 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 w i th measurements carried out under circumstances relevant for the use of the model; - be relevant to the conditions in the area of use. 6. Where metabolites, degradation or reaction products are referred to in the specific principles, only those that are relevant for the proposed criterion shall be taken into consideration. 13 2. Specific principles 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. 2. 1. Efficacy 2. 1. 1. Where the proposed use concerns the control of or protection against an organism, Member States shall evaluate the possibility that this organism could be harmful under the agricultural, plant health and environmental (including climatic) conditions in the area of the proposed use. 2. 1. 2. Where the proposed use concerns an effect other than the control of or protection against an organism, Member States shall evaluate whether significant damage, loss or inconvenience could occur under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use if the plant protection product were not used. 2. 1. 3. Member States shall evaluate the efficacy data on the plant protection product as provided for in Annex III having regard to the degree of control or the extent of the effect desired and having regard to the relevant experimental conditions such as: - the choice of the crop or cultivar; - the agricultural and environmental (including climatic) conditions; 14 - 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. 2. 1. 4. Member States shall evaluate the performance of the plant protection product in a range of agricultural, plant health and environmental (including climatic) conditions likely to be encountered in practice in the area of proposed use and in particular : (i) the level, consistency and duration of the effect sought in relation to the dose in comparison w i th a suitable reference product or products and an untreated control; (ii) where relevant, effect on yield or reduction of loss in storage, in terms of quantity and/or quality, in comparison w i th 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. 15 2. 1. 5. Where the product label includes requirements for use of the plant protection product w i th other plant protection products and/or w i th adjuvants as a tank mix, Member States shall make the evaluations referred to in points 2. 1. 1 to 2. 1. 4 in relation to the information supplied for the tank mix. Where the product label includes recommendations for use of the plant protection product w i th other plant protection products and/or w i th adjuvants as a tank mix, Member States shall evaluate the appropriateness of the mix and of its conditions of use. 2. 2. Absence of unacceptable effects on plants or plant products 2. 2. 1. Member States shall evaluate the degree of adverse effects on the treated crop after use of the plant protection product according to the proposed conditions of use in comparison, where relevant, w i th a suitable reference product or products, where they exist, and/or an untreated control. (a) This evaluation will take into consideration the following information: (t) the efficacy data provided for in Annex III; (ii) other relevant information on the plant protection product such as nature of the preparation, dose, method of application, number and timing of applications; (iii) all relevant information on the active substance as provided for in Annex II, including mode of action, vapour pressure, volatility and water solubility. 16 (b) This evaluation will include: (i) the nature, frequency, level and duration of observed phytotoxic effects and the agricultural, plant health and environmental (including climatic) conditions that affect these; (ii) the differences between main cultivars w i th regard to their sensitivity to phytotoxic effects; (iii) the part of the treated crop or plant products where phytotoxic effects are observed; (iv) the adverse impact on the yield of the treated crop or plant products in terms of quantity and/or quality; (v) the adverse impact on treated plants or plant products to be used for propagation, in terms of viability, germination, sprouting, rooting and establishment; (vi) where volatile products are concerned, the adverse impact on adjacent crops. 2. 2. 2. Where the available data indicate that the active substance or significant metabolites, degradation and reaction products persist in soils and/or in or on plant substances in significant quantities after use of the plant protection product according to the proposed conditions of use, Member States shall evaluate the degree of adverse effects on subsequent crops. This evaluation will be carried out as specified in point 2. 2. 1. 17 2. 2. 3. Where the product label includes requirements for use of the plant protection product w i th other plant protection products or w i th adjuvants as a tank mix, the evaluation as specified in point 2. 2. 1 will be carried out in relation to the information supplied for the tank mix. 2. 3. Impact on vertebrates to be controlled 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 : (i) all relevant information as provided for in Annex II and the results of the evaluation thereof, including the toxicological and metabolism studies; (ii) all relevant information on the plant protection product as provided for in Annex III, including toxicological studies and efficacy data. 2. 4. Impact on human or animal health 18 2. 4. 1. Arising from the plant protection product 2. 4. 1. 1. Member States shall evaluate operator exposure to the active substance and/or to toxicologically relevant compounds in the plant protection product likely to occur under the proposed conditions of use (including in particular dose, application method and climatic conditions) using by preference realistic data on exposure and, if such data are not available, a suitable, validated calculation model. (a) This evaluation will take into consideration the following information : (i) 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; (ii) other relevant information on the active substances such as physical and chemical properties; (iii) the toxicological studies provided for in Annex III, including where appropriate dermal absorption studies; 19 (iv) 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. (b) 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. 20 2. 4. 1. 2. Member States shall examine information relating to the nature and characteristics of the packaging proposed w i th particular reference to the following aspects: 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 w i th the contents. 2. 4. 1. 3. Member States shall examine the nature and characteristics of the protective clothing and equipment proposed w i th particular reference to the following aspects: obtainability and suitability; ease of wearing taking into account physical stress and climatic conditions. 2. 4. 1. 4. Member States shall evaluate the possibility of exposure of other humans (bystanders or workers exposed after the application of the plant protection product) or animals to the active substance and/or to other toxicologically relevant compounds in the plant protection product under the proposed conditions of use. 21 This evaluation will take into consideration the following information : (i) 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; (ii) the toxicological studies provided for in Annex III, including where appropriate dermal absorption studies; (iii) 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. 22 2. 4. 2. Arising from residues 2. 4. 2. 1. Member States shall evaluate the specific information on toxicology as provided for in Annex II and in particular: 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. 2. 4. 2. 2. Prior to evaluating the residue levels in the reported trials or in products of animal origin Member States shall examine the following information: data on the proposed good agricultural practice, including data on application as provided for in Annex ill 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. 23 2. 4. 2. 3. On the basis of suitable statistical models Member States shall evaluate the residue levels observed in the reported trials. This evaluation shall be made for each proposed use and shall take into consideration: (i) the proposed conditions of use of the plant protection product; (ii) 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; (iii) the specific information on residues in or on treated plants, plant products, food and feed as provided for in Annex II and t he results of the evaluation thereof; (iv) the realistic possibilities of extrapolating data from one crop to another. 2. 4. 2. 4. Member States shall evaluate the residue levels observed in products of animal origin, taking into consideration the information provided for in Annex III, Part A, point 8. 4 and residues resulting from other uses. 2. 4. 2. 5. Member States shall estimate the potential exposure of consumers through diet and, where relevant, other ways of exposure, using a suitable calculation model. This evaluation will take account, where relevant, of other sources of information such as other authorized uses of plant protection products containing the same active substance or which give rise to the same residues. 24 2. 4. 2. 6. Member States shall, where relevant, estimate the exposure of animals, taking into account the residue levels observed in treated plants or plant products intended to be fed to animals. 2. 5. Influence on the environment 2. 5. 1. Fate and distribution in the environment 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: 2. 5. 1. 1. Member States shall evaluate the possibility of the plant protection product reaching the soil under the proposed conditions of use; if this possibility exists they shall estimate the rate and the route of degradation in the soil, the mobility in the soil and the change in the total concentration (extractable and non-extractable f ) of the active substance and of relevant metabolites, degradation and reaction products that could be expected in the soil in the area of envisaged use after use of the plant protection product according to the proposed conditions of use. This evaluation will take into consideration the following information: (i) the specific information on fate and behaviour in soil as provided for in Annex II and the results of the evaluation thereof; (*) Non-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. 25 (ii) 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; (iii)* all information on the plant protection product as provided for in Annex III, including the information on distribution and dissipation in soil; (iv) 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. 26 2. 5. 1. 2. Member States shall evaluate the possibility of the plant protection product reaching the groundwater under the proposed conditions of use; if this possibility exists, they shall estimate, using a suitable calculation model validated at Community level, the concentration of the active substance and of relevant metabolites, degradation and reaction products that could be expected in the groundwater in the area of envisaged use after use of the plant protection product according to the proposed conditions of use. As long as there is no validated Community calculation model, Member States shall base their evaluation especially on the results of mobility and persistence in soil studies as provided for in Annexes II and III. This evaluation will also take into consideration the following information: (i) the specific information on fate and behaviour in soil and water as provided for in Annex II and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: molecular weight; solubility in water; octanol/water partition coefficient; 27 vapour pressure; volatilization rate; hydrolysis rate in relation to pH and identity of breakdown products; dissociation constant; (iii) all information on the plant protection product as provided for in Annex III, including the information on distribution and dissipation in soil and water; (iv) 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; (v) where relevant, data on dissipation including transformation and sorption in the saturated zone; (vi) where relevant, data on the procedures for drinking water abstraction and treatment in the area of envisaged use; (vii) where relevant, monitoring data on the presence or absence of the active : jc5tanc3 and rsievar. t ,~staboiites, ciegraaaiion 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. 28 2. 5. 1. 3. Member States shall evaluate the possibility of the plant protection product reaching surface water under the proposed conditions of use; if this possibility exists they shall estimate, using a suitable calculation model validated at Community level, the short-term and long-term predicted concentration of the active substance and of metabolites, degradation and reaction products that could be expected in the surface water in the area of envisaged use after use of the plant protection product according to the proposed conditions of use. 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: (i) the specific information on fate and behaviour in soil and water as provided for in Annex II and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: molecular weight; solubility in water; octanol/water partition coefficient; 29 vapour pressure; volatilization rate; hydrolysis rate in relation to pH and identity of breakdown products; dissociation constant; (iii) 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; (iv) possible routes of exposure: drift; run-off; overspray; discharge via drains; leaching; deposit in the atmosphere; (v) 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; 30 (vi) where relevant, data on the procedures for drinking water abstraction and treatment in the area of envisaged use. 2. 5. 1. 4. Member States shall evaluate the possibility of the plant protection product being dissipated in the air under the proposed conditions of use; if this possibility exists they shall make the best possible estimation, using where appropriate a suitable, validated calculation model, of the concentration of the active substance and of relevant metabolites, degradation and reaction products that could be expected in the air after use of the plant protection product according to the proposed conditions of use. This evaluation will take into consideration the following information: (i) 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; (ii) 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; 31 (iii) all relevant information on the plant protection product as provided for in Annex III,, including the information on distribution and dissipation in air. 2. 5. 1. 5. Member States shall evaluate the procedures for destruction or decontamination of the plant protection product and its packaging. 2. 5. 2. Impact on non-target species When calculating toxicity/exposure ratios Member States shall take into consideration toxicity to the most sensitive relevant organism used in the tests. 2. 5. 2. 1. Member States shall evaluate the possibility of exposure of birds and other terrestrial vertebrates to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the extent of the short-term and long-term risk to be expected for these organisms, including their reproduction, after use of the plant protection product according to the proposed conditions of use. (a) This evaluation will take into consideration the following information: (i) 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; (ii) 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; 32 (iii) 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. (b) This evaluation will include: (i) 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; (ii) 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, prédation on invertebrates, feeding on vertebrate prey, contact by overspraying or w i th treated vegetation; (iii) 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 LD50, LC50 or NOEC expressed on an active substance basis and the estimated exposure expressed in mg/kg body weight. 2. 5. 2. 2. Member States shall evaluate the possibility of exposure of aquatic organisms to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the degree of short-term and long-term risk to be expected for aquatic organisms after use of the plant protection product according to the proposed conditions of use. 33 [a) This evaluation will take into consideration the following information: (i) the specific information relating to the effects on aquatic organisms as provided for in Annex II and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: - solubility in water; - octanol/water partition coefficient; - vapour pressure; - volatilization rate; - KOC; - biodégradation 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; 34 (iii) all relevant information on the plant protection product as provided for in Annex III and in particular the effects on aquatic organisms; (iv) 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. (b) This evaluation will include: (i) the fate and distribution of residues of the active substance and of relevant metabolites, breakdown and reaction products in water, sediment or fish; (ii) a calculation of the acute toxicity/exposure ratio for fish and Daphnia. This ratio is defined as the quotient of respectively acute LC50 or EC50 and the predicted short-term environmental concentration; (iii) a calculation of the algal growth inhibition/exposure ratio for algae. This ratio is defined as the quotient of the EC50 and the predicted short-term environmental concentration; (iv) 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; (v) where relevant, the bioconcentration in fish and possible exposure of predators of fish, including humans; 35 (vi) 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. 2. 5. 2. 3. Member States shall evaluate the possibility of exposure of honeybees to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the short-term and long-term risk to be expected for honeybees after use of the plant protection product according to the proposed conditions of use. (a) This evaluation will take into consideration the following information: (i) the specific information on toxicity to honeybees as provided for in Annex II and the results of the evaluation thereof; (ii) 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); 36 (iii) all relevant information on the plant protection product as provided for in Annex III, including the toxicity to honeybees; (iv) 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. (b) This evaluation will include: (i) the ratio between the maximum application rate expressed in grammes of active substance per hectare and the contact and oral LD50 expressed in /;g of active substance per bee (hazard quotients) and where necessary the persistence of residues on or, where relevant, in the treated plants; (ii) 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. • • 2. 5. 2. 4. Member States shall evaluate the possibility of exposure of beneficial arthropods other than honeybees to the plant protection product under the proposed conditions of use; if this possibility exists they will assess the lethal and sublethal effects on these organisms to be expected and the reduction in their activity after use of the plant protection product according to the proposed conditions of use. 37 This evaluation will take into consideration the following information: (i) the specific information on toxicity to honeybees and other beneficial arthropods as provided for in Annex II and the results of the evaluation thereof; (ii) 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); (iii) 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; 38 maximum application rate; maximum number and timetable of applications. (iv) 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. 2. 5. 2. 5. Member States shall evaluate the possibility of exposure of earthworms and other non-target soil macro-organisms to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the degree of short-term and long-term risk to be expected to these organisms after use of the plant protection product according to the proposed conditions of use. (a) This evaluation will take into consideration the following information : (i) 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; (ii) other relevant information on the active substance such as: - solubility in water; - octanol/water partition coefficient; 39 - Kd for adsorption; - vapour pressure; - hydrolysis rate in relation to pH and identity of breakdown products; - photodegradatior* rate and identity of breakdown products; - DT50 and DT90 for degradation in the soil; (iii) 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; (iv) 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. (b) This evaluation will include: (i) the lethal and sublethal effects; (ii) the predicted initial and long-term environmental concentration; 40 (iii) a calculation of the acute toxicity/exposure ratio (defined as the quotient of LC50 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); (iv) where relevant, the bioconcentration and persistence of residues in earthworms. 2. 5. 2. 6. Member States shall, where the evaluation carried out under Part B, point 2. 5. 1. 1, does not exclude the possibility of the plant protection product reaching the soil under the proposed conditions of use, evaluate the impact on microbial activity such as the impact on nitrogen and carbon mineralization processes in the soil after use of the plant protection product according to the proposed conditions of use. This evaluation will take into consideration the following information: (i) all relevant information on the active substance,including the specific information relating to the effects on non-target soil micro-organisms as provided for in Annex II and the results of the evaluation thereof; (ii) all relevant information on the plant protection product as provided for in Annex ill, including the effects on non-target soil micro-organisms; (iii) 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. (iv) all available information from biological primary screening. 41 2. 6. Analytical methods Member States shall evaluate the analytical methods proposed for post-registration control and monitoring purposes, to determine: 2. 6. 1. for formulation analysis: 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: (i) the data on analytical methods as provided for in Annex II and the results of the evaluation thereof; (ii) 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); (iii) the limit of detection and determination of the proposed methods for impurities; 42 2. 6. 2. for residue analysis: the residues of the active substance, metabolites, breakdown or reaction products resulting from authorized uses of the plant protection product and w h i ch are of toxicological, ecotoxicological or environmental significance. This evaluation will take into consideration the following information: (i) the data on analytical methods as provided for in Annex II and the results of the evaluation thereof; (ii) 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; (iii) the limit of detection of the proposed methods; (iv) the limit of determination of the proposed methods. 43 2. 7. Physical and chemical properties 2. 7. 1. Member States shall evaluate the actual active substance content of the plant protection product and its stability during storage. 2. 7. 2. Member States shall-evaluate the physical and chemical properties of the plant protection product and in particular: 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: (i) 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; (ii) the data on the physical and chemical properties of the plant protection product as provided for in Annex III. 2. 7. 3. Where proposed label claims include requirements or recommendations for use of the plant protection product with other plant protection products or adjuvants as a tank mix, the physical and chemical compatibility of the products in the mixture must be evaluated. 44 C. DECISION-MAKING 1. General principles 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. 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. 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. 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. 45 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. 6. Before issuing an authorization, Member States shall ensure that the label of the product: 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) C) and in Article 16(g) and (h) of Directive 91/414/EEC. 7. Before issuing authorizations, Member States shall: (a) ensure that the proposed packaging is in accordance with the provisions of Directive 78/631/EEC; [1) OJ No L 206, 29. 7. 1978, p. 13. Directive as last amended by Directive 92/32/EEC (OJ No L 154, 5. 6. 1992, p. 1). 46 (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; the procedures for the decontamination and destruction of the packagings, are in accordance w i th the relevant regulatory provisions. 8. No authorization shall be granted unless all the requirements referred to in Section 2 are satisfied. However: (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 outweigh the possible adverse effects of its use. Any restrictions on use of the product relating to non-compliance w i th some of the aforementioned requirements must be mentioned on the label, and non-compliance w i th 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 w i th integrated control measures or organic farming; 47 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 w i th 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 t wo laboratories, an authorization shall be granted for one year to permit the applicant to demonstrate the reproducibility of those methods in accordance w i th 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): (a) define, where possible, preferably in close co-operation w i th the applicant, measures to improve the performance of the plant protection product, and/or 48 (b) define, where possible, in close co-operation w i th 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 performance or potential risks arising under the changed conditions. 2. Specific principles The specific principles shall apply without prejudice to the general principles referred to in Section 1. 2. 1. Efficacy 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. 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. 49 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. 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). 2. 1. 5. Where proposed label claims include requirements for use of the preparation w i th other specified plant protection products or adjuvants as a tank mix, the mixture must achieve the desired effect and comply w i th the principles referred to in points 2. 1. 1 to 2. 1. 4. Where proposed label claims include recommendations for use of the preparation w i th other 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 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. 50 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. 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. 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. 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. 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. 2. 2. 7. Where proposed label claims include requirements for use of the preparation w i th other plant protection products or adjuvants, as a tank mix, the mixture must comply w i th the principles referred to in points 2. 2. 1 to 2. 2. 6. 51 2. 2. 8. The proposed instructions for cleaning the application equipment must be both practical and effective so that they can be applied w i th ease so as to ensure the removal of residual traces of the plant protection product which could subsequently cause damage. 2. 3. Impact on vertebrates to be controlled An authorization for a plant protection product intended to eliminate vertebrates shall be granted only w h e n: death is synchronous w i th 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 2. 4. 1. Arising from the plant protection product 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 acceptable operator exposure level (AOEL). 52 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/EECof 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 (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. 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. (2) OJ No L 327, 3. 12. 1980, p. 8. Directive as last amended by Directive 88/642/EEC (OJ No L 356, 24. 12. 1988,p. 74). (3) O J N o L 1 9 6 , 2 6. 7. 1990, p. 1. 53 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 w i th the Community provisions referred to in point 2. 4. 1. 1. 2. 4. 1. 5. Waiting and re-entry safety periods or other precautions must be established in such a w ay that no adverse impact on animals occurs. 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. 2. 4. 2. Arising from residues 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. 54 2. 4. 2. 2. Where no Community MRL ( * *) 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. (**) 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 O, Council Directive 86/362/EEC of 24 July 1 9 86 on the fixing of maximum levels for pesticide residues in and on cereals (b), 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 (c), Council Regulation (EEC) No 2 3 7 7 / 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 origin (d), 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 (•) or Council Directive 91/132/EEC of 4 March 1991 amending Directive 74/63/EEC on undesirable substances and products in feedingstuffs (f). (a) OJ No L 340, 9. 1 2. 1976, p. 26. Directive as last amended by Directive 96/32/EC (0J No L144; 18. 6. 1996, p. 12). OJ No L 2 2 1, 7. 8. 1 9 8 6, p. 3 7. Directive as last amended by Directive 96/33/EC (OJ No L 1 4 4, 1 8. 6. 1 9 9 6, p. 35). O J N o L 2 2 1, 7. 8. 1 9 8 6, p. 4 3. Directive as last amended by Directive 96/33/EC (OJ No L 1 4 4, 1 8. 6. 1 9 9 6, p. 35). OJ No L 2 2 4, 18. 8. 1 9 9 0, p. 1. Regulation as last amended by Commission Regulation (EEC) No 9 5 5 / 94 (OJ No L 108, 2 9. 4. 1 9 9 4 , p. 8). OJ No L 3 5 0, 14. 1 2. 1 9 9 0, p. 7 1. Directive as amended by Directive 96/32/EC (OJ No L 144, 1 8. 6. 1 9 9 6, p. 12). OJ No L 6 6, 13. 3. 1 9 9 1, p. 16. (b) (c) (d) (a) (f) 55 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 w i th Article 4(1 )(f) of this Directive. 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 w i th the procedures provided for in the relevant Community legislation. 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. Taking into account all registered uses, the proposed use cannot be authorized if the best possible estimate of dietary exposure exceeds the acceptable daily intake (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. 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. 56 2. 5. Influence on the environment 2. 5. 1. Fate and distribution in the environment 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: during tests in the field, persist in soil for more than one year (i. e. D T9 0> 1 year and D T5 0>3 months), or during laboratory tests, form not extractable residues in amounts exceeding 7 0% of the initial dose after 100 days w i th 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. 57 2. 5. 1. 2 (a) 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: (i) the maximum permissible concentration laid d o wn by Council Directive 80/778/EEC(4) of 15 July 1980 relating to the quality of water intended for human consumption, or (ii) the maximum concentration laid d o wn 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 d o w n, the concentration corresponding to one tenth of the ADI laid d o wn 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: 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 1 6 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. (4) OJ No L 2 2 9, 3 0. 8. 1 9 8 0, p. 1 1. Directive as last amended by Directive 91 /692/EEC (OJ No L 3 7 7, 3 1. 1 2. 1 9 9 1, p. 4 8 ). (5) OJ No L 1 9 4, 2 5. 7. 1 9 7 5, p. 3 4. Directive as last amended by Directive 91/692/EEC (OJ No L 3 7 7, 3 1. 1 2. 1 9 9 1, p. 48). 58 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. 59 2. 5. 2. Impact on non-target species 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: the acute and short-term toxicity/exposure ratio for birds and other non- target terrestrial vertebrates is less than 10 on the basis of LD50 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: 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 0 00 for plant protection products containing active substances w h i ch are readily biodegradable or greater than 100 for those which are not readily biodegradable, 60 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. 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. 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. 61 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 2 5% 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. 2. 6. Analytical methods 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: 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: (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 7 0% and 1 1 0% w i th a relative standard deviation of <_ 2 0 %; 62 (iii) the repeatability must be less than the following values for residues in foodstuffs: Residue level Difference mg/kg mg/kg Difference in % 0,01 0,1 1 >1 0,005 0,025 0,125 50 25 12,5 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 Difference mg/kg mg/kg Difference in % 0,01 0,1 1 >1 0,01 0,05 0,25 100 50 25 25 Intermediate values are determined by interpolation from a log-log graph; 63 (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 0,5 - 0 , 05 < 0,05 0,1 0,1 - 0,02 MRL x 0 , 5. 2. 7. Physical and chemical properties 2. 7. 1. Where an appropriate FAO specification exists, that specification must be met. 2. 7. 2. Where no appropriate FAO specification exists, the physical and chemical properties of the product must meet the following requirements: (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: 64 Declared content in g/kg or g/l at 20°C Tolerance up to 25 ± 1 5% homogeneous formulation ± 2 5% non-homogeneous formulation more than 25 up to 100 more than 100 up to 2 50 more than 2 50 up to 5 00 ± 1 0% ± 6% ± 5% more than 5 00 ± 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. " 65 IMPACT ASSESSMENT FORM THE IMPACT OF THE PROPOSAL ON BUSINESS with special reference to small and medium sized enterprises Title of proposal: Proposal for a Council Directive to establish Annex VI of Council directive 91/414/EEC concerning the placing of plant protection products on the market The proposal 1. Taking account of the principle of subsidiarity, why is Comunity legislation necessary in this area and what are it main aims? Council Directive 91/414/EEC provides in article 18 par. 1 that uniform principles for the evaluation and decision making on plant protection products have to be established as Annex VI to the Directive. The uniform principles aim to ensure that all Member States will apply the requirements of the Directive in an equivalent manner and at the high level of protection of human and animal health and of the environment saught by the Directive. The impact on business: 2. Who will be affected by the proposal? which sectors of business which sizes of business (what is the concentration of small and medium sized firms) are there particular geographical areas of the Community where these business Cc are found? All companies applying for the authorisation of plant protection products will have to ensure that their products meet the criteria established in the uniform principles. 3. What will business have to do to comply with the proposal? Companies will have to meet the data requirements set already in Annexes II and III of the Directive in order to demonstrate that under the proposed conditions of use the plant protection product to be authorized meets the requirements of the Directive. 4. What economic effects is the proposal likely to have? on employment on investment and the creation of new business on the competitive position of business The proposal, and in particular the provisions concerning the protection of groundwater, will have an impact on industry, including agriculture. Authorizations of certain plant protection products already on the market in certain Member States, may have to be withdrawn or restricted, so that the use of some products with an interesting use pattern for agriculture may disappear or be restricted because they are not considered to be acceptable any more according to the criteria established in the current proposal. Certain new products with interesting use characteristics may for the same reasons not reach the EC market. This may in particular affect EC industry and agriculture in their competitivity with third countries where less stringent requirements apply. However Council Directive 91/414/EEC requires a high level of protection of human and animal health and the environment. This proposal for uniform principles has to make this requirement operational with the consequence that the E. U. will take a lead position towards a sustainable use of plant protection products in its territory. O Does the proposal contain measures to take account of the specific situation of small and medium sized firms (reduced or different requirements etc. )? There are no specific provisions for small and medium sized firms. Consultation List the organisation which have been consulted about the proposal and outline their main views. European Crop Protection Association (ECPA) and European Crop Care Association (ECCA) contest the scientific basis for the very strict critérium applied for groundwater (0,1/xg/l) propose that time-weighted avarages for the concentrations in groundwater be used and that the weaknesses of model calculations are taken into account; want a derogation for compounds which present unequivocal advances in protection of human health and the environment but which do occasionally not meet the groundwater requirement COPA and COGECA supports in general the approach of DG VI to progress the proposal for new uniform principles as rapidly as possible supports ECPA concerning the approach for the protection of groundwater (see comments of ECPA above). £? ISSN 0254-1475 COM(97) 284 final DOCUMENTS EN 05 10 15 Catalogue number : CB-CO-97-274-EN-C ISBN 92-78-21143-5 Office for Official Publications of the European Communities L-2985 Luxembourg £9