Avis juridique important

Commission Directive 95/36/EC of 14 July 1995 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market Official Journal L 172 , 22/07/1995 P. 0008 - 0020

COMMISSION DIRECTIVE 95/36/EC of 14 July 1995 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), as last amended by Commission Directive 95/35/EC (2), and in particular Article 18 (2) thereof, Whereas Annexes II and III to Directive 91/414/EEC provide the requirements for the dossier to be submitted by applicants respectively for the inclusion of an active substance in Annex I and for the authorization of a plant protection product; Whereas it is necessary to indicate, in Annexes II and III to Directive 91/414/EEC, to the applicants as precisely as possible any details on the required information, such as the circumstances, conditions and technical protocols under which certain data have to be generated; whereas these provisions should be introduced as soon as available in order to permit applicants to use them in the preparation of their files; Whereas it is possible to introduce now more precision with regard to the data requirements concerning fate and behaviour in the environment of the active substance provided for in Annex II, Part A, Section 7; Whereas it is also possible to introduce now more precision with regard to the data requirements concerning fate and behaviour in the environment of the plant protection product provided for in Section 9 of Part A of Annex III, Part A, Section 9; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, HAS ADOPTED THIS DIRECTIVE: Article 1 Directive 91/414/EEC is amended as follows: 1. in Part A of Annex II, the section headed '7. Fate and behaviour in the environment` is replaced by Annex I hereto; 2. in Part A of Annex III, the section headed '9. Fate and behaviour in the environment` is replaced by Annex II hereto. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply, not later than 30 April 1996, with the provisions of this Directive. They shall immediately inform the Commission thereof. When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States. Article 3 This Directive shall enter into force on 1 July 1995. Article 4 This Directive is addressed to the Member States. Done at Brussels, 14 July 1995. For the Commission Ritt BJERREGAARD Member of the Commission ANNEX I '7. FATE AND BEHAVIOUR IN THE ENVIRONMENT Introduction (i) The information provided, taken together with that for one or more preparations containing the active substance, must be sufficient to pemit an assessment of the fate and behaviour of the active substance in the environment, and of the non-target species likely to be at risk from exposure to the active substance, its metabolites, degradation and reaction products, where they are of toxicological or environmental significance. (ii) In particular, the information provided for the active substance, together with other relevant information, and that provided for one or more preparations containing it, should be sufficient to: - decide whether, or not, the active substance can be included in Annex I, - specify appropriate conditions or restrictions to be associated with any inclusion in Annex I, - classify the active substance as to hazard; - specify the hazard symbols, the indications of danger, and relevant risk and safety phrases for the protection of the environment, which are to be included on packaging (containers), - predict the disribution, fate, and behaviour in the environment of the active substance and relevant metabolites, degradation and reaction products as well as the times courses involved, - identify non-target species and populations for which hazards a rise because of potential exposure, and - identify measures necesary to minimize contamination of the environment and impact on non-target species. (iii) A detailed description (specification) of the material used, as provided for under Section 1, point 11 must be provided. Where testing is done using active substance the material used should be of that specification that will be used in the manufacture of preparations to be authorized except where radio-labelled material is used. Where studies are conducted using active substance produced in the laboratory or in a pilot plant production system, the studies must be repeated using active substance as manufactured, unless it can be justified that the test material used is essentially the same for the purposes of environmental testing and assessment. (iv) Where radio-labelled test material is used, radio-labels should be positioned at sites (one or more as necessary), to facilitate elucidation of metabolic and degradative pathways and to facilitate investigation of the distribution of the active substance and of its metabolite, reaction and degradation products in the environment. (v) It may be necessary to conduct separate studies for metabolites, degradation or reaction products, where these products can constitute a relevant risk to non-target organisms or to the quality of water, soil and air and where their effects cannot be evaluated by the available results relating to the active substance. Before such studies are performed the information from the Sections 5 and 6 has to be taken into account. (vi) Where relevant, tests should be designed and data analysed using appropriate statistical methods. Full details of the statistical anaylsis should be reported (e.g. all point estimates should be given with confidence intervals, exact p-values should be given rather than stating significant/non significant). 7.1. Fate and behaviour in soil All relevant information on the type and the properties of the soil used in the studies, including pH, organic carbon content, cation exchange capacity, particle size distribution and water holding capacity, particle size distribution and water holding capacity at pF=0 and pF=2,5 has to be reported in accordance with relevant ISO or other international standards. The microbial biomass of soils used for laboratory degradation studies must be determined just prior to the commencement and at the end of the study. It is recommended to use as much as possible the same soils throughout all laboratory soil studies. The soils used for degradation or mobility studies must be selected such that they are representative of the range of soils typical of the various Community regions where use exists or is anticipated, and be such that: - they cover a range of organic carbon content, particle size distribution and pH values; and - where on the basis of other information, degradation or mobility are expected to be pH dependent (e.g. solubility and hydrolysis rate - paragraphs 2.7 and 2.8), they cover the following pH ranges: - 4,5 to 5,5 - 6 to 7, and - 8 (approximately). Soils used must, wherever possible, be freshly sampled. If use of stored soils is unavoidable, storage should be properly carried out for a limited time under defined and reported conditions. Soils stored for longer periods of time can only be used for adsorption/desorption studies. The soil chosen to begin studying should not have extreme characteristics with respect to parameters such as particle size distribution, organic carbon content and pH. Soils should be collected and handled in accordance with ISO 10381-6 (Soil quality - Sampling - Guidance on the collection, handling and storage of soil for the assessment of microbial processes in the laboratory). Any deviations must be reported and justified. Field studies should be carried out in conditions as close to normal agricultural practice as possible on a range of soil types and climatic conditions representative of the area(s) of use. Weather conditions shall be reported in cases where field studies are conducted. 7.1.1. Route and rate of degradation 7.1.1.1. Route of degradation Aim of the tests The data and information provided, together with other relevant data and information, should be sufficient to: - identify, where feasable, the relative importance of the types of process involved (balance between chemical and biological degradation), - identify the individual components present which at any time account for more than 10 % of the amount of active substance added, including, where feasible, non-extractable residues, - identify where possible also individual components present which account for less than 10 % of the amount of active substance added, - establish the relative proportions of the components present (mass balance), and - permit the soil residue of concern and to which non-target species are or may be exposed, to be defined. Where a reference is made to non-extractable residues these 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. 7.1.1.1.1. Aerobic degradation Circumstances in which required The degradation pathway or pathways must always be reported except where the nature and manner of use of preparations containing the active substance, preclude soil contamination such as uses on stored products or wound healing treatments for trees. Test conditions The degradation pathway or pathways must be reported for one soil. Results obtained must be presented in the form of schematic drawings showing the pathways involved, and in the form of balance sheets which show the distribution of radio-label as a function of time, as between: - active substance, - CO2, - volatile compounds other than CO2, - individual identified transformation products, - extractable substances not identified, and - non-extractable residues in soil. The investigation of degradation pathways must include all feasible steps to characterise and quantify non-extractable residues formed after 100 days when exceeding 70 % of the applied dose of the active substance. The techniques and methodologies applied are best selected on a case-by-case basis. A justification must be provided where the compounds involved are not characterized. The duration of the study is normally 120 days, except where after a shorter period the levels of non-extractable residues and CO2 are such that they can be extrapolated in a reliable way to 100 days. Test guideline Setac - Procedures for assessing the environmental fate and ecotoxicity of pesticides (1). 7.1.1.1.2. Supplementary studies - Anaerobic degradation Circumstances in which required An anaerobic degradation study must be reported unless it can be justified that exposure of the plant protection products containing the active substance to anaerobic conditions is unlikely to occur. Test conditions and test guideline The same provisions as provided for under the corresponding paragraph of point 7.1.1.1.1 apply. - Soil photolysis Circumstances in which required A soil photolysis study must be reported unless it can be justified that deposition of the active substance at the soil surface is unlikely to occur. Test guideline Setac - Procedures for assessing the Environmental fate and ecotoxicity of pesticides. 7.1.1.2. Rate of degradation 7.1.1.2.1. Laboratory studies Aim of the tests The soil degradation studies should provide best possible estimates of the time taken for degradation of 50 % and 90 % (DT50lab and DT90lab), of the active substance, and of relevant metabolites, degradation and reaction products under laboratory conditions. - Aerobic degradation Circumstances in which required The rate of degradation in soil must always be reported, except where the nature and manner of use of plant protection products containing the active substance preclude soil contamination such as uses on stored products or wound healing treatments for trees. Test conditions The rate of aerobic degradation of the active substance in three soil types additional to that referred to in paragraph 7.1.1.1.1. must be reported. In order to investigate the influence of temperature on degradation, one additional study at 10 °C has to be performed on one of the soils used for the investigation of degradation at 20 °C until a validated Community calculation model for the extrapolation of degradation rates at low temperatures is available. The duration of the study is normally 120 days except if more than 90 % of the active substance is degraded before that period expires. Similar studies for three soil types must be reported for all relevant metabolites, degradation and reaction products which occur in soil and which at any time during the studies account for more than 10 % of the amount of active substance added, except where their DT50 values were able to be determined from the results of the degradation studies with the active substance. Test guideline Setac - Procedures for assessing the environmental fate and ecotoxicity of pesticides. - Anaerobic degradation Circumstances in which required The rate of anaerobic degradation of the active substance must be reported where an anaerobic study has to be performed according to point 7.1.1.1.2. Test conditions The rate of anaerobic degradation of the active substance must be carried out in the soil used in the anaerobic study performed according to point 7.1.1.1.2. The duration of the study is normally 120 days except if more than 90 % of the active substance is degraded before that period expires. Similar studies for one soil must be reported for all relevant metobolites, degradation and reaction products which occur in soil and which at any time during the studies account for more than 10 % of the amount of active substance added, except where their DT50 values were able to be determined from the results of the degradation studies with the active substance. Test guideline Setac - Procedures for assessing the environmental fate and ecotoxicity of pesticides. 7.1.1.2.2. Field studies - Soil dissipation studies Aim of the test The soil dissipation studies should provide estimates of the time taken for dissipation of 50 % and 90 % (DT50f and DT90f), of the active substance under field conditions. Where relevant, information on relevant metabolites, degradation and reaction products must be reported. Circumstances in which required Where plant protection products containing the active substance are intended to be used in cold climatic conditions, the tests have to be conducted where DT50lab, determined at 10 °C and at a moisture content of the soil related to a pF value of 2 to 2,5 (suction pressure) is greater than 90 days. Test conditions Individual studies on a range of representative soils (normally four different types) must be continued until > 90 % of the amount applied have dissipated. The maximum duration of the studies is 24 months. Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides. - Soil residue studies Aim of the test Soil residue studies should provide estimates of the soil residue levels at harvest or at time of cowing or planting succeeding crops. Circumstances in which required Soil residue studies must be reported where DT50lab is greater than one-third of the period between the application and harvest and where absorption by the succeeding crop is possible, except where soil residues at sowing or planting of a succeeding crop can be reliably estimated from the data of the soil dissipation studies or where it can be justified that these residues can not be phytotoxic to or leave unacceptable residues in rotational crops. Test conditions Individual studies must be continued until harvest or time of sowing or planting succeeding crops, unless > 90 % of the amount applied have dissipated. Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides. - Soil accumulation studies Aim of the tests The tests should provide sufficient data to evaluate the possibility of accumulation of residues of the active substance and of relevant metabolites, degradation and reaction products. Circumstances in which required Where on the basis of soil dissipation studies it is established that DT90f > one year and where repeated application is envisaged, whether in the same growing season or in succeeding years, the possibility of accumulation of residues in soil and the level at which a plateau concentration is achieved must be investigated except where reliable information can be provided by a model calculation or another appropriate assessment. Test conditions Long term field studies must be done on two relevant soils and involve multiple applications. Before performing these studies the applicant shall seek the agreement of the competent authorities on the type of study to be performed. 7.1.2. Adsorption and desorption Aim of the test The data and information provided, together with other relevant data and information, should be sufficient to establish the absorption coefficient of the active substance and of relevant metabolites, degradation and reaction products. Circumstances in which required The studies must always be reported except where the nature and manner of use of preparations containing the active substance, preclude soil contamination such as uses on stored products or wound healing trees. Testo conditions Studies on the active substance must be reported for four soil types. Similar studies, for at least three soil types, must be reported for all relevant metabolites, degradation and reaction products which in soil degradation studies account at any time for more than 10 % of the amount of active substance added. Test guideline OECD method 106 7.1.3. Mobility in the soil 7.1.3.1. Column leaching studies Aim of the test The test should provide sufficient data to evaluate the mobility and leaching potential of the active substance and if possible of relevant metabolities, degradation and reaction products. Circumstances in which required Studies in four soils must be carried out where in the absorption and desorption studies provided for under point 7.1.2 it is not possible to obtain reliable absorption coefficient values. Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides. 7.1.3.2. Aged residue column leaching Aim of the test The test should provide sufficient data to estimate the mobility and leaching potential of relevant metabolites, degradation and reaction products. Circumstances in which required The studies must be performed except: - where the nature and manner of use of preparations containing the active substance, preclude soil contamination such as uses on stored products or wound healing treatments for trees, or - where a separate study for the metabolite, degradation or reaction product in accordance to point 7.1.2 or 7.1.3.1 was performed. Test conditions The period(s) of ageing should be determined from inspection of the degradation patterns of active substance and metabolites to ensure that a relevant spectrum of metabolites is present at the time of leaching. Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides. 7.1.3.3. Lysimeter studies or field leaching studies Aim of the tests The test should provide data on: - the mobility in soil, - the potential for leaching to ground water, - The potential distribution in soil. Circumstances in which requried Expert judgement will be necessary to decide whether lysimeter studies or field leaching studies should be carried out, taking into account the results of degradation and other mobility studies and the predicted environmental concentrations in groundwater (PECGW), calculated in accordance with the provisions of Annex III, Section 9. The type and conditions of the study to be conducted should be discussed with the competent authorities. Test conditions Great care is necessary in design of both experimental installations and individual studies, to ensure that results obtained can be used for assessment purposes. Studies should cover the realistic worst case situation, taking into account the soil type, climatic conditions, the application rate and the frequency and period of application. Water percolating from soil columns must be analyzed at suitable intervals, while residues in plant material must be determined at harvest. Residues in the soil profile in at least five layers must be determined on termination of experimental work. Intermediate sampling must be avoided, since removal of plants (except for harvesting according to normal agricultural practice) and soil cross influences the leaching process. Precipitation, soil and air temperatures have to be recorded at regular intervals (at least on a weekly base). - Lysimeter studies Test conditions The minimal depth of the lysimeters should be 100 cm; their maximal depth should be 130 cm. The soil cross must be undisturbed. Soil temperatures must be similar to those pertaining in the field. Where necessary, supplementary irrigation must be provided to ensure optimal plant growth and to ensure that the quantity of infiltration water is similar to that in the regions for which authorization is sought. When during the study the soil has to be disturbed for agricultural reasons it must not be disturbed deeper than 25 cm. - Field leaching studies Test conditions Information on the groundwater table in the experimental fields must be submitted. If soil cracking is observed during the study this must be fully described. Great attention should be given to the number and the location of water collection devices. The placement of these devices in the soil should not result in preferential flow paths. Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides. 7.2. Fate and behaviour in water and air Aim of the tests The information and data provided , taken together with that provided for one or more preparations containing the active substance, and other relevant information, should be sufficient to establish, or permit estimation of: - persistence in water systems (bottom sediment and water, including suspended particles), - the extent to which water, sediment organisms and air are at risk, - potential for contamination of surface water and groundwater. 7.2.1. Route and rate of degradation in aquatic systemes (as far as not covered by point 2.9) Aim of the tests The data and information provided, together with other relevant data and information, should be sufficient to: - identify the relative importance of the types of processes involved (balance between chemical and biological degradation), - where possible, identify the individual components present, - establish the relative proportions of the components present and their distribution as between water, including suspended particles, and sediment, and - permit the residue of concern and to which non-target species are or may be exposed, to be defined. 7.2.1.1. Hydrolytic degradation Circumstances in which required The test must always be performed for relevant metabolites, degradation and reaction products which account at any time for more than 10 % of the amount of active substance added unless sufficient information on their degradation is available from the test performed in accordance with point 2.9.1. Test conditions and test guideline The same provisions as provided under the corresponding paragraphs of point 2.9.1 apply. 7.2.1.2. Photochemical degradation Circumstances in which required The test must always be performed for relevant metabolites, degradation and reaction products which account at any time for more than 10 % of the amount of active substance added unless sufficient information on their degradation is available from the test performed in accordance with points 2.9.2 and 2.9.3. Test conditions and test guideline The same provisions as provided under the corresponding paragraphs of points 2.9.2 and 2.9.3 apply. 7.2.1.3. Biological degradation 7.2.1.3.1. "Ready biodegradability" Circumstances in which required The test must always be performed unless it is not required under the provisions of Annex VI to Directive 67/548/EEC for the classification of the active substance. Test guideline EEC method C4. 7.2.1.3.2. Water/sediment study Circumstances in which required The test must be reported unless it can be justified that contamination of surface water will not occur. Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides. 7.2.1.4. Degradation in the saturated zone Circumstances in which required Transformation rates in the saturated zone of active substances and of relevant metabolites, degradation and reaction products can provide useful information on the fate of these substances in the groundwater. Test conditions Expert judgement is required to decide whether this information is necessary. Before performing these studies the applicant shall seek the agreement of the competent authorities on the type of study to be performed. 7.2.2. Route and rate of degradation in air (as far as not covered by point 2.10) Guidance under development. 7.3. Definition of the residue In the light of the chemical composition of residues occurring in soil, water or air, resulting from use, or proposed use, of a plant protection product containing the active substance a proposal for the definition of the residue must be submitted, taking account of both the levels found and their toxicological and environmental significance. 7.4. Monitoring data Available monitoring data concerning fate and behaviour of the active substance and relevant metabolites, degradation and reaction products must be reported.` (1) ANNEX II '9. FATE AND BEHAVIOUR IN THE ENVIRONMENT Introduction (i) The information provided, taken together with that for the active substance as provided for in Annex II, must be sufficient to permit an assessment of the fate and behaviour of the plant protection product in the environment, and of the non-target species likely to be at risk from exposure to it. (ii) In particular, the information provided for the plant protection product, together with other relevant information, and that provided for the active substance, should be sufficient to: - specify the hazard symbols, the indications of danger, and relevant risk and safety phrases for the protection of the environment, which are to be included on packaging (containers), - predict the distribution, fate, and behaviour in the environment as well as the time courses involved, - identify non-target species and populations for which hazards arise because of potential exposure, and - identify measures necessary to minimize contamination of the environment and impact on non-target species. (iii) Where radio-labelled test material is used, the provisions of Annex II, Chapter 7, introduction, point (iv) apply. (iv) Where relevant tests should be designed and data analysed using appropriate statistical methods. Full details of the statistical analysis should be reported (e.g. all point estimates should be given with confidence intervals, exact p-values should be given rather than stating significant/non significant). (v) Predicted environmental concentrations in soil (PECS), water (PECSW and PECGW) and air (PECA). Justified estimates must be made of the expected concentrations of the active substance and relevant metabolites, degradation and reaction products, in soil, groundwater, surface water and air, following use as proposed or already occurring. In addition a realistic worst-case estimation must be made. For the purposes of the estimation of such concentrations the following definitions apply: - Predicted environmental concentration in soil (PECS) The level of residues in the top layer of the soil and to which non-target soil organisms may be exposed (acute and chronic exposure). - Predicted environmental concentration in surface water (PECSW) The level of residues, in surface water to which non-target aquatic organisms may be exposed (acute and chronic exposure). - Predicted environmental concentration in groundwater (PECGW) The level of residues in groundwater. - Predicted environmental concentration in air (PECA) The level of residues in air, to which man, animals and other non-target organisms may be exposed (acute and chronic exposure). For the estimation of these concentrations all relevant information on the plant protection product and on the active substance must be taken into account. A useful approach for these estimations is provided in the EPPO schemes for environmental risk assessment (1). Where relevant the parameters provided for in this section should be used. When models are used for estimation of predicted environmental concentrations they must: - make a best-possible estimation of all relevant processes involved taking into account realistic parameters and assumptions, - where possible be reliably validated with measurements carried out under circumstances relevant for the use of the model, - be relevant to the conditions in the area of use. The information provided must, where relevant, include that referred to in Annex II, Part A, point 7: and 9.1 Fate and behaviour in soil Where appropriate, the same provisions relating to the information to be provided on the soil used and on its selection apply as provided for under Annex II, point 7.1. 9.1.1. Rate of degradation in soil 9.1.1.1. Laboratory studies Aim of the test The soil degradation studies should provide best possible estimates of the time taken for degradation of 50 and 90 % (DT50lab and DT90lab) of the active substance under laboratory conditions. Circumstances in which required The persistence and behaviour of plant protection products in soil must be investigated unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance to the requirements of Annex II, point 7.1.1.2. This extrapolation is, for example, not possible for slow release formulations. Test conditions The rate of aerobic and/or anaerobic degradation in soil must be reported. The duration of the study is normally 120 days except if more than 90 % of the active substance is degraded before that period expires. Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides. 9.1.1.2. Field studies - Soil dissipation studies Aim of the test The soil dissipation studies should provide best-possible estimates of the time taken for dissipation of 50 and 90 % (DT50f and DT90f), of the active substance under field conditions. Where relevant, information on relevant metabolites, degradation and reaction products must be collected. Circumstances in which required The dissipation and behaviour of plant protection products in soil must be investigated unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance to the requirements of Annex II, point 7.1.1.2. This extrapolation is, for example, not possible for slow-release formulations. Test conditions and test guideline The same provisions as provided under the corresponding paragraph of Annex II, point 7.1.1.2.2. apply. - Soil residue studies Aim of the test Soil residue studies should provide estimates of the soil residue levels at harvest or at time of sowing or planting succeeding crops. Circumstances in which required Soil residue studies must be reported unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance with the requirements of Annex II, point 7.1.1.2.2. This extrapolation is, for example, not possible for slow-release formulations. Test conditions The same provisions as provided under the corresponding paragraph of Annex II, point 7.1.1.2.2. apply. Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides. - Soil accumulation studies Aim of the tests The tests should provide sufficient data to evaluate the possibility of accumulation of residues of the active substance and of relevant metabolites, degradation and reaction products. Circumstances in which required Soil accumulation studies must be reported unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance with the requirements of Annex II, point 7.1.1.2.2. This extrapolation is, for example, not possible for slow-release formulations. Test conditions The same provisions as provided under the corresponding paragraph of Annex II, point 7.1.1.2.2. apply. Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides. 9.1.2. Mobility in the soil Aim of the test The test should provide sufficient data to evaluate the mobility and leaching potential of the active substance and relevant metabolites, degradation and reaction products. 9.1.2.1. Laboratory studies Circumstances in which required The mobility of plant protection products in soil must be investigated unless it is possible to extrapolate from data obtained in accordance with the requirements of Annex II, points 7.1.2 and 7.1.3.1. This extrapolation is, for example, not possible for slow-release formulations. Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides. 9.1.2.2. Lysimeter studies or field leaching studies Aim of the tests The test should provide data on: - the mobility of the plant protection product in soil, - the potential for leaching to ground water, - the potential distribution in soils. Circumstances in which required Expert judgement will be necessary to decide whether field leaching studies or lysimeter studies should be carried out, taking into account the results of degradation and mobility studies and the calculated PECs. The type of study to be conducted should be discussed with the competent authorities. These studies must be performed unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance with the requirements of Annex II, point 7.1.3. This extrapolation is, for example, not possible for slow release formulations. Test conditions The same provisions as provided for under the corresponding paragraph of Annex II, point 7.1.3.3 apply. 9.1.3. Estimation of expected concentrations in soil PECs estimations must relate both to a single application at the highest rate of application for which authorization is sought, and to the maximum number and highest rates of application for which authorization is sought, for each relevant soil tested, and are expressed in terms of mg of active substance and of relevant metabolites, degradation and reaction products per kg of soil. The factors to be considered in making PECs estimations relate to direct and indirect application to soil, drift, run off, and leaching and include processes such as volatilization, adsorption, hydrolysis, photolysis, aerobic and anaerobic degradation. For the purposes of PECs calculations, the bulk density of soils can be assumed to be 1,5 g/cm3 dry weight, while the depth of the soil layer is assumed to be 5 cm for applications at the soil surface and 20 cm when incorporation in the soil is involved. Where ground cover is present at time of application, it is to be assumed that 50 % (minimum) of the applied dose reaches the soil surface unless actual experimental data give more specific information. Initial, short-term and long-term PECs calculations (time weighted averages) must be provided: - initial: immediately after application, - short-term: 24 hours, 2 days and 4 days after last application, - long-term: 7, 28, 50 and 100 days after last application, where relevant. 9.2. Fate and behaviour in water 9.2.1. Estimation of concentrations in groundwater The groundwater contamination routes have to be defined taking into account relevant agricultural, plant health, and environmental (including climatic) conditions. Suitable estimations (calculations) of predicted environmental concentration in groundwater PECGW, of active substance and relevant metabolites, degradation and reaction products, must be submitted. PEC estimations must relate to the maximum number and highest rates of application, for which authorization is sought. Expert judgment is required to decide if additional field tests could provide useful information. Before performing these studies the applicant shall seek the agreement of the competent authorities on the type of study to be performed. 9.2.2. Impact on water treatment procedures In cases where this information is necessary in the framework of a conditional authorization as meant in Annex VI, Part C, point 2.5.1.2 (b), the information provided should permit to establish or to estimate effectiveness of water treatment procedures (drinking water and sewage treatment), and impact on such procedures. Before performing any studies the applicant shall seek the agreement of the competent authorities on the type of information to be provided. 9.2.3. Estimation of concentrations in surface water The surface water contamination routes have to be defined taking into account relevant agricultural, plant health, and environmental (including climatic) conditions. Suitable estimations (calculations) of predicted environmental concentration in surface water PECsw, of active substance and relevant metabolites, degradation and reaction products, must be submitted. PEC estimations must relate to the maximum number and highest rates of application, for which authorization is sought, and be relevant to lakes, ponds, rivers, canals, streams, irrigation/drainage canals and drains. The factors to be considered in making PECsw estimations relate to direct application to water, drift, run-off, discharge via drains and atmospheric deposition, and include processes such as volatilization, adsorption, advection, hydrolysis, photolysis, biodegradation, sedimentation and re-suspension. Initial, short-term and long-term PECsw calculations relevant to static and slow moving water bodies (time weighted averages) must be provided: - initial: immediately after application, - short-term: 24 hours, 2 days and 4 days after last application, - long-term: 7, 14, 21, 28, and 42 days after last application, where relevant. Expert judgment is required to decide if additional field tests could provide useful information. Before performing these studies the applicant shall seek the agreement of the competent authorities on the type of study to be performed. 9.3. Fate and behaviour in air Guidance under development.`

COMMISSION DIRECTIVE 95/36/EC of 14 July 1995 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), as last amended by Commission Directive 95/35/EC (2), and in particular Article 18 (2) thereof,

Whereas Annexes II and III to Directive 91/414/EEC provide the requirements for the dossier to be submitted by applicants respectively for the inclusion of an active substance in Annex I and for the authorization of a plant protection product;

Whereas it is necessary to indicate, in Annexes II and III to Directive 91/414/EEC, to the applicants as precisely as possible any details on the required information, such as the circumstances, conditions and technical protocols under which certain data have to be generated; whereas these provisions should be introduced as soon as available in order to permit applicants to use them in the preparation of their files;

Whereas it is possible to introduce now more precision with regard to the data requirements concerning fate and behaviour in the environment of the active substance provided for in Annex II, Part A, Section 7;

Whereas it is also possible to introduce now more precision with regard to the data requirements concerning fate and behaviour in the environment of the plant protection product provided for in Section 9 of Part A of Annex III, Part A, Section 9;

Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 91/414/EEC is amended as follows:

1. in Part A of Annex II, the section headed '7. Fate and behaviour in the environment` is replaced by Annex I hereto;

2. in Part A of Annex III, the section headed '9. Fate and behaviour in the environment` is replaced by Annex II hereto.

Article 2

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply, not later than 30 April 1996, with the provisions of this Directive. They shall immediately inform the Commission thereof.

When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States.

Article 3

This Directive shall enter into force on 1 July 1995.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 14 July 1995.

For the Commission Ritt BJERREGAARD Member of the Commission

ANNEX I

'7. FATE AND BEHAVIOUR IN THE ENVIRONMENT Introduction (i) The information provided, taken together with that for one or more preparations containing the active substance, must be sufficient to pemit an assessment of the fate and behaviour of the active substance in the environment, and of the non-target species likely to be at risk from exposure to the active substance, its metabolites, degradation and reaction products, where they are of toxicological or environmental significance.

(ii) In particular, the information provided for the active substance, together with other relevant information, and that provided for one or more preparations containing it, should be sufficient to:

- decide whether, or not, the active substance can be included in Annex I,

- specify appropriate conditions or restrictions to be associated with any inclusion in Annex I,

- classify the active substance as to hazard;

- specify the hazard symbols, the indications of danger, and relevant risk and safety phrases for the protection of the environment, which are to be included on packaging (containers),

- predict the disribution, fate, and behaviour in the environment of the active substance and relevant metabolites, degradation and reaction products as well as the times courses involved,

- identify non-target species and populations for which hazards a rise because of potential exposure, and - identify measures necesary to minimize contamination of the environment and impact on non-target species.

(iii) A detailed description (specification) of the material used, as provided for under Section 1, point 11 must be provided. Where testing is done using active substance the material used should be of that specification that will be used in the manufacture of preparations to be authorized except where radio-labelled material is used.

Where studies are conducted using active substance produced in the laboratory or in a pilot plant production system, the studies must be repeated using active substance as manufactured, unless it can be justified that the test material used is essentially the same for the purposes of environmental testing and assessment.

(iv) Where radio-labelled test material is used, radio-labels should be positioned at sites (one or more as necessary), to facilitate elucidation of metabolic and degradative pathways and to facilitate investigation of the distribution of the active substance and of its metabolite, reaction and degradation products in the environment.

(v) It may be necessary to conduct separate studies for metabolites, degradation or reaction products, where these products can constitute a relevant risk to non-target organisms or to the quality of water, soil and air and where their effects cannot be evaluated by the available results relating to the active substance. Before such studies are performed the information from the Sections 5 and 6 has to be taken into account.

(vi) Where relevant, tests should be designed and data analysed using appropriate statistical methods.

Full details of the statistical anaylsis should be reported (e.g. all point estimates should be given with confidence intervals, exact p-values should be given rather than stating significant/non significant).

7.1. Fate and behaviour in soil All relevant information on the type and the properties of the soil used in the studies, including pH, organic carbon content, cation exchange capacity, particle size distribution and water holding capacity, particle size distribution and water holding capacity at pF=0 and pF=2,5 has to be reported in accordance with relevant ISO or other international standards.

The microbial biomass of soils used for laboratory degradation studies must be determined just prior to the commencement and at the end of the study.

It is recommended to use as much as possible the same soils throughout all laboratory soil studies.

The soils used for degradation or mobility studies must be selected such that they are representative of the range of soils typical of the various Community regions where use exists or is anticipated, and be such that:

- they cover a range of organic carbon content, particle size distribution and pH values; and - where on the basis of other information, degradation or mobility are expected to be pH dependent (e.g. solubility and hydrolysis rate - paragraphs 2.7 and 2.8), they cover the following pH ranges:

- 4,5 to 5,5 - 6 to 7, and - 8 (approximately).

Soils used must, wherever possible, be freshly sampled. If use of stored soils is unavoidable, storage should be properly carried out for a limited time under defined and reported conditions. Soils stored for longer periods of time can only be used for adsorption/desorption studies.

The soil chosen to begin studying should not have extreme characteristics with respect to parameters such as particle size distribution, organic carbon content and pH.

Soils should be collected and handled in accordance with ISO 10381-6 (Soil quality - Sampling - Guidance on the collection, handling and storage of soil for the assessment of microbial processes in the laboratory). Any deviations must be reported and justified.

Field studies should be carried out in conditions as close to normal agricultural practice as possible on a range of soil types and climatic conditions representative of the area(s) of use. Weather conditions shall be reported in cases where field studies are conducted.

7.1.1. Route and rate of degradation 7.1.1.1. Route of degradation Aim of the tests The data and information provided, together with other relevant data and information, should be sufficient to:

- identify, where feasable, the relative importance of the types of process involved (balance between chemical and biological degradation),

- identify the individual components present which at any time account for more than 10 % of the amount of active substance added, including, where feasible, non-extractable residues,

- identify where possible also individual components present which account for less than 10 % of the amount of active substance added,

- establish the relative proportions of the components present (mass balance), and - permit the soil residue of concern and to which non-target species are or may be exposed, to be defined.

Where a reference is made to non-extractable residues these 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.

7.1.1.1.1. Aerobic degradation Circumstances in which required The degradation pathway or pathways must always be reported except where the nature and manner of use of preparations containing the active substance, preclude soil contamination such as uses on stored products or wound healing treatments for trees.

Test conditions The degradation pathway or pathways must be reported for one soil.

Results obtained must be presented in the form of schematic drawings showing the pathways involved, and in the form of balance sheets which show the distribution of radio-label as a function of time, as between:

- active substance,

- CO2,

- volatile compounds other than CO2,

- individual identified transformation products,

- extractable substances not identified, and - non-extractable residues in soil.

The investigation of degradation pathways must include all feasible steps to characterise and quantify non-extractable residues formed after 100 days when exceeding 70 % of the applied dose of the active substance. The techniques and methodologies applied are best selected on a case-by-case basis. A justification must be provided where the compounds involved are not characterized.

The duration of the study is normally 120 days, except where after a shorter period the levels of non-extractable residues and CO2 are such that they can be extrapolated in a reliable way to 100 days.

Test guideline Setac - Procedures for assessing the environmental fate and ecotoxicity of pesticides (1).

7.1.1.1.2. Supplementary studies - Anaerobic degradation Circumstances in which required An anaerobic degradation study must be reported unless it can be justified that exposure of the plant protection products containing the active substance to anaerobic conditions is unlikely to occur.

Test conditions and test guideline The same provisions as provided for under the corresponding paragraph of point 7.1.1.1.1 apply.

- Soil photolysis Circumstances in which required A soil photolysis study must be reported unless it can be justified that deposition of the active substance at the soil surface is unlikely to occur.

Test guideline Setac - Procedures for assessing the Environmental fate and ecotoxicity of pesticides.

7.1.1.2. Rate of degradation 7.1.1.2.1. Laboratory studies Aim of the tests The soil degradation studies should provide best possible estimates of the time taken for degradation of 50 % and 90 % (DT50lab and DT90lab), of the active substance, and of relevant metabolites, degradation and reaction products under laboratory conditions.

- Aerobic degradation Circumstances in which required The rate of degradation in soil must always be reported, except where the nature and manner of use of plant protection products containing the active substance preclude soil contamination such as uses on stored products or wound healing treatments for trees.

Test conditions The rate of aerobic degradation of the active substance in three soil types additional to that referred to in paragraph 7.1.1.1.1. must be reported.

In order to investigate the influence of temperature on degradation, one additional study at 10 °C has to be performed on one of the soils used for the investigation of degradation at 20 °C until a validated Community calculation model for the extrapolation of degradation rates at low temperatures is available.

The duration of the study is normally 120 days except if more than 90 % of the active substance is degraded before that period expires.

Similar studies for three soil types must be reported for all relevant metabolites, degradation and reaction products which occur in soil and which at any time during the studies account for more than 10 % of the amount of active substance added, except where their DT50 values were able to be determined from the results of the degradation studies with the active substance.

Test guideline Setac - Procedures for assessing the environmental fate and ecotoxicity of pesticides.

- Anaerobic degradation Circumstances in which required The rate of anaerobic degradation of the active substance must be reported where an anaerobic study has to be performed according to point 7.1.1.1.2.

Test conditions The rate of anaerobic degradation of the active substance must be carried out in the soil used in the anaerobic study performed according to point 7.1.1.1.2.

The duration of the study is normally 120 days except if more than 90 % of the active substance is degraded before that period expires.

Similar studies for one soil must be reported for all relevant metobolites, degradation and reaction products which occur in soil and which at any time during the studies account for more than 10 % of the amount of active substance added, except where their DT50 values were able to be determined from the results of the degradation studies with the active substance.

Test guideline Setac - Procedures for assessing the environmental fate and ecotoxicity of pesticides.

7.1.1.2.2. Field studies - Soil dissipation studies Aim of the test The soil dissipation studies should provide estimates of the time taken for dissipation of 50 % and 90 % (DT50f and DT90f), of the active substance under field conditions. Where relevant, information on relevant metabolites, degradation and reaction products must be reported.

Circumstances in which required Where plant protection products containing the active substance are intended to be used in cold climatic conditions, the tests have to be conducted where DT50lab, determined at 10 °C and at a moisture content of the soil related to a pF value of 2 to 2,5 (suction pressure) is greater than 90 days.

Test conditions Individual studies on a range of representative soils (normally four different types) must be continued until > 90 % of the amount applied have dissipated. The maximum duration of the studies is 24 months.

Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides.

- Soil residue studies Aim of the test Soil residue studies should provide estimates of the soil residue levels at harvest or at time of cowing or planting succeeding crops.

Circumstances in which required Soil residue studies must be reported where DT50lab is greater than one-third of the period between the application and harvest and where absorption by the succeeding crop is possible, except where soil residues at sowing or planting of a succeeding crop can be reliably estimated from the data of the soil dissipation studies or where it can be justified that these residues can not be phytotoxic to or leave unacceptable residues in rotational crops.

Test conditions Individual studies must be continued until harvest or time of sowing or planting succeeding crops, unless > 90 % of the amount applied have dissipated.

Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides.

- Soil accumulation studies Aim of the tests The tests should provide sufficient data to evaluate the possibility of accumulation of residues of the active substance and of relevant metabolites, degradation and reaction products.

Circumstances in which required Where on the basis of soil dissipation studies it is established that DT90f > one year and where repeated application is envisaged, whether in the same growing season or in succeeding years, the possibility of accumulation of residues in soil and the level at which a plateau concentration is achieved must be investigated except where reliable information can be provided by a model calculation or another appropriate assessment.

Test conditions Long term field studies must be done on two relevant soils and involve multiple applications.

Before performing these studies the applicant shall seek the agreement of the competent authorities on the type of study to be performed.

7.1.2. Adsorption and desorption Aim of the test The data and information provided, together with other relevant data and information, should be sufficient to establish the absorption coefficient of the active substance and of relevant metabolites, degradation and reaction products.

Circumstances in which required The studies must always be reported except where the nature and manner of use of preparations containing the active substance, preclude soil contamination such as uses on stored products or wound healing trees.

Testo conditions Studies on the active substance must be reported for four soil types.

Similar studies, for at least three soil types, must be reported for all relevant metabolites, degradation and reaction products which in soil degradation studies account at any time for more than 10 % of the amount of active substance added.

Test guideline OECD method 106 7.1.3. Mobility in the soil 7.1.3.1. Column leaching studies Aim of the test The test should provide sufficient data to evaluate the mobility and leaching potential of the active substance and if possible of relevant metabolities, degradation and reaction products.

Circumstances in which required Studies in four soils must be carried out where in the absorption and desorption studies provided for under point 7.1.2 it is not possible to obtain reliable absorption coefficient values.

Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides.

7.1.3.2. Aged residue column leaching Aim of the test The test should provide sufficient data to estimate the mobility and leaching potential of relevant metabolites, degradation and reaction products.

Circumstances in which required The studies must be performed except:

- where the nature and manner of use of preparations containing the active substance, preclude soil contamination such as uses on stored products or wound healing treatments for trees, or - where a separate study for the metabolite, degradation or reaction product in accordance to point 7.1.2 or 7.1.3.1 was performed.

Test conditions The period(s) of ageing should be determined from inspection of the degradation patterns of active substance and metabolites to ensure that a relevant spectrum of metabolites is present at the time of leaching.

Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides.

7.1.3.3. Lysimeter studies or field leaching studies Aim of the tests The test should provide data on:

- the mobility in soil,

- the potential for leaching to ground water,

- The potential distribution in soil.

Circumstances in which requried Expert judgement will be necessary to decide whether lysimeter studies or field leaching studies should be carried out, taking into account the results of degradation and other mobility studies and the predicted environmental concentrations in groundwater (PECGW), calculated in accordance with the provisions of Annex III, Section 9. The type and conditions of the study to be conducted should be discussed with the competent authorities.

Test conditions Great care is necessary in design of both experimental installations and individual studies, to ensure that results obtained can be used for assessment purposes. Studies should cover the realistic worst case situation, taking into account the soil type, climatic conditions, the application rate and the frequency and period of application.

Water percolating from soil columns must be analyzed at suitable intervals, while residues in plant material must be determined at harvest. Residues in the soil profile in at least five layers must be determined on termination of experimental work. Intermediate sampling must be avoided, since removal of plants (except for harvesting according to normal agricultural practice) and soil cross influences the leaching process.

Precipitation, soil and air temperatures have to be recorded at regular intervals (at least on a weekly base).

- Lysimeter studies Test conditions The minimal depth of the lysimeters should be 100 cm; their maximal depth should be 130 cm. The soil cross must be undisturbed. Soil temperatures must be similar to those pertaining in the field. Where necessary, supplementary irrigation must be provided to ensure optimal plant growth and to ensure that the quantity of infiltration water is similar to that in the regions for which authorization is sought. When during the study the soil has to be disturbed for agricultural reasons it must not be disturbed deeper than 25 cm.

- Field leaching studies Test conditions Information on the groundwater table in the experimental fields must be submitted. If soil cracking is observed during the study this must be fully described.

Great attention should be given to the number and the location of water collection devices. The placement of these devices in the soil should not result in preferential flow paths.

Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides.

7.2. Fate and behaviour in water and air Aim of the tests The information and data provided , taken together with that provided for one or more preparations containing the active substance, and other relevant information, should be sufficient to establish, or permit estimation of:

- persistence in water systems (bottom sediment and water, including suspended particles),

- the extent to which water, sediment organisms and air are at risk,

- potential for contamination of surface water and groundwater.

7.2.1. Route and rate of degradation in aquatic systemes (as far as not covered by point 2.9) Aim of the tests The data and information provided, together with other relevant data and information, should be sufficient to:

- identify the relative importance of the types of processes involved (balance between chemical and biological degradation),

- where possible, identify the individual components present,

- establish the relative proportions of the components present and their distribution as between water, including suspended particles, and sediment, and - permit the residue of concern and to which non-target species are or may be exposed, to be defined.

7.2.1.1. Hydrolytic degradation Circumstances in which required The test must always be performed for relevant metabolites, degradation and reaction products which account at any time for more than 10 % of the amount of active substance added unless sufficient information on their degradation is available from the test performed in accordance with point 2.9.1.

Test conditions and test guideline The same provisions as provided under the corresponding paragraphs of point 2.9.1 apply.

7.2.1.2. Photochemical degradation Circumstances in which required The test must always be performed for relevant metabolites, degradation and reaction products which account at any time for more than 10 % of the amount of active substance added unless sufficient information on their degradation is available from the test performed in accordance with points 2.9.2 and 2.9.3.

Test conditions and test guideline The same provisions as provided under the corresponding paragraphs of points 2.9.2 and 2.9.3 apply.

7.2.1.3. Biological degradation 7.2.1.3.1. "Ready biodegradability"

Circumstances in which required The test must always be performed unless it is not required under the provisions of Annex VI to Directive 67/548/EEC for the classification of the active substance.

Test guideline EEC method C4.

7.2.1.3.2. Water/sediment study Circumstances in which required The test must be reported unless it can be justified that contamination of surface water will not occur.

Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides.

7.2.1.4. Degradation in the saturated zone Circumstances in which required Transformation rates in the saturated zone of active substances and of relevant metabolites, degradation and reaction products can provide useful information on the fate of these substances in the groundwater.

Test conditions Expert judgement is required to decide whether this information is necessary. Before performing these studies the applicant shall seek the agreement of the competent authorities on the type of study to be performed.

7.2.2. Route and rate of degradation in air (as far as not covered by point 2.10) Guidance under development.

7.3. Definition of the residue In the light of the chemical composition of residues occurring in soil, water or air, resulting from use, or proposed use, of a plant protection product containing the active substance a proposal for the definition of the residue must be submitted, taking account of both the levels found and their toxicological and environmental significance.

7.4. Monitoring data Available monitoring data concerning fate and behaviour of the active substance and relevant metabolites, degradation and reaction products must be reported.` (1)

ANNEX II

'9. FATE AND BEHAVIOUR IN THE ENVIRONMENT Introduction (i) The information provided, taken together with that for the active substance as provided for in Annex II, must be sufficient to permit an assessment of the fate and behaviour of the plant protection product in the environment, and of the non-target species likely to be at risk from exposure to it.

(ii) In particular, the information provided for the plant protection product, together with other relevant information, and that provided for the active substance, should be sufficient to:

- specify the hazard symbols, the indications of danger, and relevant risk and safety phrases for the protection of the environment, which are to be included on packaging (containers),

- predict the distribution, fate, and behaviour in the environment as well as the time courses involved,

- identify non-target species and populations for which hazards arise because of potential exposure, and - identify measures necessary to minimize contamination of the environment and impact on non-target species.

(iii) Where radio-labelled test material is used, the provisions of Annex II, Chapter 7, introduction, point (iv) apply.

(iv) Where relevant tests should be designed and data analysed using appropriate statistical methods.

Full details of the statistical analysis should be reported (e.g. all point estimates should be given with confidence intervals, exact p-values should be given rather than stating significant/non significant).

(v) Predicted environmental concentrations in soil (PECS), water (PECSW and PECGW) and air (PECA).

Justified estimates must be made of the expected concentrations of the active substance and relevant metabolites, degradation and reaction products, in soil, groundwater, surface water and air, following use as proposed or already occurring. In addition a realistic worst-case estimation must be made.

For the purposes of the estimation of such concentrations the following definitions apply:

- Predicted environmental concentration in soil (PECS) The level of residues in the top layer of the soil and to which non-target soil organisms may be exposed (acute and chronic exposure).

- Predicted environmental concentration in surface water (PECSW) The level of residues, in surface water to which non-target aquatic organisms may be exposed (acute and chronic exposure).

- Predicted environmental concentration in groundwater (PECGW) The level of residues in groundwater.

- Predicted environmental concentration in air (PECA) The level of residues in air, to which man, animals and other non-target organisms may be exposed (acute and chronic exposure).

For the estimation of these concentrations all relevant information on the plant protection product and on the active substance must be taken into account. A useful approach for these estimations is provided in the EPPO schemes for environmental risk assessment (1). Where relevant the parameters provided for in this section should be used.

When models are used for estimation of predicted environmental concentrations they must:

- make a best-possible estimation of all relevant processes involved taking into account realistic parameters and assumptions,

- where possible be reliably validated with measurements carried out under circumstances relevant for the use of the model,

- be relevant to the conditions in the area of use.

The information provided must, where relevant, include that referred to in Annex II, Part A, point 7: and 9.1 Fate and behaviour in soil Where appropriate, the same provisions relating to the information to be provided on the soil used and on its selection apply as provided for under Annex II, point 7.1.

9.1.1. Rate of degradation in soil 9.1.1.1. Laboratory studies Aim of the test The soil degradation studies should provide best possible estimates of the time taken for degradation of 50 and 90 % (DT50lab and DT90lab) of the active substance under laboratory conditions.

Circumstances in which required The persistence and behaviour of plant protection products in soil must be investigated unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance to the requirements of Annex II, point 7.1.1.2. This extrapolation is, for example, not possible for slow release formulations.

Test conditions The rate of aerobic and/or anaerobic degradation in soil must be reported.

The duration of the study is normally 120 days except if more than 90 % of the active substance is degraded before that period expires.

Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides.

9.1.1.2. Field studies - Soil dissipation studies Aim of the test The soil dissipation studies should provide best-possible estimates of the time taken for dissipation of 50 and 90 % (DT50f and DT90f), of the active substance under field conditions. Where relevant, information on relevant metabolites, degradation and reaction products must be collected.

Circumstances in which required The dissipation and behaviour of plant protection products in soil must be investigated unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance to the requirements of Annex II, point 7.1.1.2. This extrapolation is, for example, not possible for slow-release formulations.

Test conditions and test guideline The same provisions as provided under the corresponding paragraph of Annex II, point 7.1.1.2.2. apply.

- Soil residue studies Aim of the test Soil residue studies should provide estimates of the soil residue levels at harvest or at time of sowing or planting succeeding crops.

Circumstances in which required Soil residue studies must be reported unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance with the requirements of Annex II, point 7.1.1.2.2. This extrapolation is, for example, not possible for slow-release formulations.

Test conditions The same provisions as provided under the corresponding paragraph of Annex II, point 7.1.1.2.2. apply.

Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides.

- Soil accumulation studies Aim of the tests The tests should provide sufficient data to evaluate the possibility of accumulation of residues of the active substance and of relevant metabolites, degradation and reaction products.

Circumstances in which required Soil accumulation studies must be reported unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance with the requirements of Annex II, point 7.1.1.2.2. This extrapolation is, for example, not possible for slow-release formulations.

Test conditions The same provisions as provided under the corresponding paragraph of Annex II, point 7.1.1.2.2. apply.

Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides.

9.1.2. Mobility in the soil Aim of the test The test should provide sufficient data to evaluate the mobility and leaching potential of the active substance and relevant metabolites, degradation and reaction products.

9.1.2.1. Laboratory studies Circumstances in which required The mobility of plant protection products in soil must be investigated unless it is possible to extrapolate from data obtained in accordance with the requirements of Annex II, points 7.1.2 and 7.1.3.1. This extrapolation is, for example, not possible for slow-release formulations.

Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides.

9.1.2.2. Lysimeter studies or field leaching studies Aim of the tests The test should provide data on:

- the mobility of the plant protection product in soil,

- the potential for leaching to ground water,

- the potential distribution in soils.

Circumstances in which required Expert judgement will be necessary to decide whether field leaching studies or lysimeter studies should be carried out, taking into account the results of degradation and mobility studies and the calculated PECs. The type of study to be conducted should be discussed with the competent authorities.

These studies must be performed unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance with the requirements of Annex II, point 7.1.3. This extrapolation is, for example, not possible for slow release formulations.

Test conditions The same provisions as provided for under the corresponding paragraph of Annex II, point 7.1.3.3 apply.

9.1.3. Estimation of expected concentrations in soil PECs estimations must relate both to a single application at the highest rate of application for which authorization is sought, and to the maximum number and highest rates of application for which authorization is sought, for each relevant soil tested, and are expressed in terms of mg of active substance and of relevant metabolites, degradation and reaction products per kg of soil.

The factors to be considered in making PECs estimations relate to direct and indirect application to soil, drift, run off, and leaching and include processes such as volatilization, adsorption, hydrolysis, photolysis, aerobic and anaerobic degradation. For the purposes of PECs calculations, the bulk density of soils can be assumed to be 1,5 g/cm3 dry weight, while the depth of the soil layer is assumed to be 5 cm for applications at the soil surface and 20 cm when incorporation in the soil is involved. Where ground cover is present at time of application, it is to be assumed that 50 % (minimum) of the applied dose reaches the soil surface unless actual experimental data give more specific information.

Initial, short-term and long-term PECs calculations (time weighted averages) must be provided:

- initial: immediately after application,

- short-term: 24 hours, 2 days and 4 days after last application,

- long-term: 7, 28, 50 and 100 days after last application, where relevant.

9.2. Fate and behaviour in water 9.2.1. Estimation of concentrations in groundwater The groundwater contamination routes have to be defined taking into account relevant agricultural, plant health, and environmental (including climatic) conditions.

Suitable estimations (calculations) of predicted environmental concentration in groundwater PECGW, of active substance and relevant metabolites, degradation and reaction products, must be submitted.

PEC estimations must relate to the maximum number and highest rates of application, for which authorization is sought.

Expert judgment is required to decide if additional field tests could provide useful information. Before performing these studies the applicant shall seek the agreement of the competent authorities on the type of study to be performed.

9.2.2. Impact on water treatment procedures In cases where this information is necessary in the framework of a conditional authorization as meant in Annex VI, Part C, point 2.5.1.2 (b), the information provided should permit to establish or to estimate effectiveness of water treatment procedures (drinking water and sewage treatment), and impact on such procedures. Before performing any studies the applicant shall seek the agreement of the competent authorities on the type of information to be provided.

9.2.3. Estimation of concentrations in surface water The surface water contamination routes have to be defined taking into account relevant agricultural, plant health, and environmental (including climatic) conditions.

Suitable estimations (calculations) of predicted environmental concentration in surface water PECsw, of active substance and relevant metabolites, degradation and reaction products, must be submitted.

PEC estimations must relate to the maximum number and highest rates of application, for which authorization is sought, and be relevant to lakes, ponds, rivers, canals, streams, irrigation/drainage canals and drains.

The factors to be considered in making PECsw estimations relate to direct application to water, drift, run-off, discharge via drains and atmospheric deposition, and include processes such as volatilization, adsorption, advection, hydrolysis, photolysis, biodegradation, sedimentation and re-suspension.

Initial, short-term and long-term PECsw calculations relevant to static and slow moving water bodies (time weighted averages) must be provided:

- initial: immediately after application,

- short-term: 24 hours, 2 days and 4 days after last application,

- long-term: 7, 14, 21, 28, and 42 days after last application, where relevant.

Expert judgment is required to decide if additional field tests could provide useful information. Before performing these studies the applicant shall seek the agreement of the competent authorities on the type of study to be performed.

9.3. Fate and behaviour in air Guidance under development.`