Avis juridique important

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31996L0012

Commission Directive 96/12/EC of 8 March 1996 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)

Official Journal L 065 , 15/03/1996 P. 0020 - 0037

COMMISSION DIRECTIVE 96/12/EC of 8 March 1996 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 95/36/EC (2), and in particular Article 18 (2) thereof,Whereas Annexes II and III to Directive 91/414/EEC set out the requirements for the dossier to be submitted by applicants respectively for the inclusion of an active substance in Annex I of that Directive 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 now possible to introduce more precision with regard to the data requirements concerning ecotoxicological studies on the active substance provided for in Part A, point 8, of Annex II to Directive 91/414/EEC;Whereas it is also now possible to introduce more precision with regard to the data requirements concerning ecotoxicological studies on the plant protection product provided for in Part A, point 10, of Annex III to Directive 91/414/EEC;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, point 8 'Ecotoxicological studies on the active substance` is replaced by Annex I hereto;2. in Part A of Annex III, points 10 'Ecotoxicological studies` and 11 'Summary and evaluation of points 9 and 10` are replaced by Annex II hereto.Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 March 1997. 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 April 1996.Article 4 This Directive is addressed to the Member States.Done at Brussels, 8 March 1996.For the CommissionRitt BJERREGAARDMember of the Commission(1) OJ No L 230, 19. 8. 1991, p. 1.(2) OJ No L 172, 22. 7. 1995, p. 8.ANNEX I '8. ECOTOXICOLOGICAL STUDIESIntroduction(i) The information provided, taken together with that for one or more preparations containing the active substance, must be sufficient to permit an assessment of the impact on non-target species (flora and fauna), likely to be at risk from exposure to the active substance, its metabolites, degradation and reaction products, where they are of environmental significance. Impact can result from single, prolonged or repeated exposure and can be reversible or irreversible.(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,- permit an evaluation of short- and long-term risks for non-target species - populations, communities, and processes - as appropriate,- classify the active substance as to hazard,- specify the precautions necessary for the protection of non-target species, and- specify the hazard symbols, the indications of danger, and relevant risk and safety phrases for the protection of the environment, to be mentioned on packaging (containers).(iii) There is a need to report all potentially adverse effects found during routine ecotoxicological investigations and to undertake and report, where required by the competent authorities, such additional studies which may be necessary to investigate the probable mechanisms involved and assess the significance of these effects. All available biological data and information which is relevant to the assessment of the ecotoxicological profile of the active substance must be reported.(iv) The information on fate and behaviour in the environment, generated and submitted in accordance with points 7.1 to 7.4, and on residue levels in plants generated and submitted in accordance with point 6 is central to the assessment of impact on non-target species, in that together with information on the nature of the preparation and its manner of use, it defines the nature and extent of potential exposure. The toxicokinetic and toxicological studies and information submitted in accordance with points 5.1 to 5.8 provide essential information as to toxicity to vertebrate species and the mechanisms involved.(v) 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).Test substance(vi) A detailed description (specification) of the material used, as provided for under point 1.11 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 radiolabelled material is used.(vii) 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 ecotoxicological testing and assessment. In cases of uncertainty, appropriate bridging studies must be submitted to serve as a basis for a decision as to the possible need for repetition of the studies.(viii) In the case of studies in which dosing extends over a period, dosing should preferably be done using a single batch of active substance if stability permits.Whenever a study implies the use of different doses, the relationship between dose and adverse effect must be reported.(ix) For all feeding studies, average achieved dose must be reported, including where possible the dose in mg/kg body weight. Where dosing via the diet is utilized the test compound must be distributed uniformly in the diet.(x) 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 and where their effects cannot be evaluated by the available results relating to the active substance. Before such studies are performed the information from points 5, 6 and 7 has to be taken into account.Test organisms(xi) In order to facilitate the assessment of the significance of test results obtained, including the estimation of intrinsic toxicity and the factors affecting toxicity, the same strain (or recorded origin) of each relevant species should, where possible, be used in the various toxicity tests specified.8.1. Effects on birds8.1.1. Acute oral toxicityAim of the testThe test should provide, where possible, LD50 values, the lethal threshold dose, time courses of response and recovery and the NOEL, and must include relevant gross pathological findings.Circumstances in which requiredThe possible effects of the active substance on birds must be investigated except where the active substance is intended solely to be included in preparations for exclusive use in enclosed spaces (e.g. in glasshouses or in food storage practice).Test conditionsThe acute oral toxicity of active substance to a quail species (Japanese quail (Coturnix coturnix japonica) or Bobwhite quail (Colinus virginianus) or to mallard duck (Anas platyrhynchos) must be determined. The highest dose used in tests need not exceed 2 000 mg/kg body weight.Test guidelineSetac - Procedures for assessing the environmental fate and ecotoxicity of pesticides (1).8.1.2. Short-term dietary toxicityAim of the testThe test should provide the short term dietary toxicity (LC50 values, lowest lethal concentration (LLC), where possible no observed effect concentrations (NOEC), time courses of response and recovery) and include relevant gross pathological findings.Circumstances in which requiredThe dietary (five-day) toxicity of the active substance to birds must always be investigated on one species except where a study in accordance with the provisions of point 8.1.3 is reported. Where its acute oral NOEL is ≤ 500 mg/kg body weight or where the short-term NOEC < 500 mg/kg food the test must be performed on a second species.Test conditionsThe first species to be studied must be either a quail species or mallard duck. If a second species must be tested it should not be related to the first species tested.Test guidelineThe test must be carried out in accordance with OECD Method 205.8.1.3. Subchronic toxicity and reproductionAim of the testThe test should provide the subchronic toxicity and reproductive toxicity of the active substance to birds.(1) Society of Environmental Toxicology and Chemistry (Setac), 1995. Procedures for Assessing the Environmental Fate and Ecotoxicity of Pesticides, ISBN 90-5607-002-9.Circumstances in which requiredThe subchronic and reproductive toxicity of the active substance to birds must be investigated, unless it can be justified that continued or repeated exposure of adults, or exposure of nest sites during the breeding season is unlikely to occur.Test guidelineThe test must be carried out in accordance with OECD Method 206.8.2. Effects on aquatic organismsThe data of the tests referred to in points 8.2.1, 8.2.4 and 8.2.6 have to be submitted for every active substance even when it is not expected that plant protection products containing it could reach surface water following the proposed conditions of use. These data are required under the provisions of Annex VI to Directive 67/548/EEC for the classification of the active substance.Data reported must be supported with analytical data on concentrations of the test substance in the test media.8.2.1. Acute toxicity to fishAim of the testThe test should provide the acute toxicity (LC50), and details of observed effects.Circumstances in which requiredThe test must always be carried out.Test conditionsThe acute toxicity of the active substance must be determined for rainbow trout (Oncorhynchus mykiss) and for a warm water fish species. Where tests with metabolites, degradation or reaction products have to be performed the species used must be the more sensitive of the two species tested with the active substance.Test guidelineThe test must be carried out in accordance with the Annex to Commission Directive 92/69/EEC (1) adapting to technical progress for the 17th time Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification and labelling of dangerous, substances, Method C1.8.2.2. Chronic toxicity to fishCircumstances in which requiredA chronic toxicity study must be carried out unless it can be justified that continued or repeated exposure of fish is unlikely to occur or unless a suitable microsom or mesocosm study is available.Expert judgment is required to decide which test has to be performed. In particular for active substance for which there are indications of particular concerns (related to the toxicity of the active substance for fish or the potential exposure) the applicant shall seek the agreement of the competent authorities on the type of test to be performed.A fish early life stage toxicity test might be appropriate where bioconcentration factors (BCF) are between 100 and 1 000 or where EC50 of the active substance < 0,1 mg/l.A fish life cycle test might be appropriate in cases where- the bioconcentration factor is greater tan 1 000 and the elimination of the active substance during a depuration phase of 14 days is lower than 95 %,or- the substance is stable in water or sediment (DT90 > 100 days).It is not necessary to perform a chronic toxicity test on juvenile fish when a fish early life stage toxicity test or a fish life cycle test has been performed; it is likewise not necessary to perform a fish early life stage toxicity test when a fish life cycle test has been performed.8.2.2.1. Chronic toxicity test on juvenile fishAim of the testThe test should provide effects on growth, the threshold level for lethal effects and for observed effects, the NOEC and details of observed effects.(2) OJ No L 383, 29. 12. 1992, p. 113.Test conditionsThe test must be conducted on juvenile rainbow trout, following exposure of 28 days to the active substance. Data on the effects on growth and behaviour must be generated.8.2.2.2. Fish early life stage toxicity testAim of the testThe test should provide effects on development, growth and behaviour, the NOEC and details of observed effects on fish early life stages.Test guidelineThe test must be carried out in accordance with OECD Method 210.8.2.2.3. Fish life cycle testAim of the testThe test will provide effects on reproduction of the parental and the viability of the filial generation.Test conditionsBefore performing these studies the applicant shall seek the agreement of the competent authorities on the type and conditions of the study to be performed.8.2.3. Bioconcentration in fishAim of the testThe test should provide the steady-state bioconcentration factors, uptake rate constants and depuration rate constants, calculated for each test compound, as well as relevant confidence limits.Circumstances in which requiredThe bioconcentration potential of active substances, of metabolites and of degradation and reaction products, likely to partition into fatty tissues (such as log pow ≥ 3 - see point 2.8 or other relevant indications of bioconcentration), must be investigated and be reported, unless it can be justified that exposure leading to bioconcentration is not likely to occur.Test guidelineThe test must be carried out in accordance with OECD Method 305E.8.2.4. Acute toxicity to aquatic invertebratesAim of the testThe test should provide the 24 and 48-hour acute toxicity of the active substance, expressed as the median effective concentration (EC50) for immobilization, and where possible the highest concentration causing no immobilization.Circumstances in which requiredThe acute toxicity must always be determined for Daphnia (preferably Daphnia magna). Where plant protection products containing the active substance are intended to be used directly on surface water additional data have to be reported on at least one representative species from each of the following groups: aquatic insects, aqautic crustaceans (on a species not related to Daphnia) and aquatic gastropod molluscs.Test guidelineThe test must be carried out in accordance with Directive 92/69/EEC, Method C2.8.2.5. Chronic toxicity to aquatic invertebratesAim of the testThe test should provide where possible EC50 values for effects such as immobilization and reproduction and the highest concentration at which no effect such as on martality or reproduction occurs (NOEC) and details of observed effects.Circumstances in which requiredA test on Daphnia and on at least one representative aquatic insect species and an aquatic gastropod mollusc species must be carried out unless it can be justified that continued or repeated exposure is not likely to occur.Test conditionsThe test with Daphnia must be continued for 21 days.Test guidelineThe test must be carried out in accordance with OECD Method 202, Part II.8.2.6. Effects on algal growthAim of the testThe test should procide EC50 values for growth and growth rate, NOEC values, and details of observed effects.Circumstances in which requiredPossible effects on algal growth of active substances must always be reported.For herbicides a test on a second species from a different taxonomic group has to be performed.Test guidelineThe test must be carried out in accordance with Directive 92/69/EEC, Method C3.8.2.7. Effects on sediment dwelling organismsAim of testThe test will measure effects on survival and development (including effects on emergence of adults for Chironomus), the relevant EC50 values and the NOEC values.Circumstances in which requiredWhere environmental fate and behaviour data required in point 7 report that an active substance is likely to partition to and persist in aquatic sediments, expert judgement should be used to decide whether an acute or a chronic sediment toxicity test in required. Such expert judgement should take into account whether effects on sediment dwelling invertebrates are likely by comparing the aquatic invertebrate toxicity EC50 data from points 8.2.4 and 8.2.5 with the predicted levels of the active substances in sediment from data in Annex III, point 9.Test conditionsBefore performing these studies the applicant shall seek the agreement of the competent authorities on the type and conditions of the study to be performed.8.2.8. Aquatic plantsA test on aquatic plants has to be performed for herbicides.Before performing these studies the applicant shall seek the agreement of the competent authorities on the type and conditions of the study to be performed.8.3. Effect on arthropods8.3.1. Bees8.3.1.1. Acute toxicityAim of the testThe test should provide the acute oral and contact LD50 value of the active substance.Circumstances in which requiredPotential impact on bees must be investigated, except where preparations containing the active substance are for exclusive use in situations where bees are not likely to be exposed such as:- food storage in enclosed spaces,- non-systemic seed dressings,- non-systemic preparations for application to soil,- non-systemic dipping treatments for transplanted crops and bulbs,- wound sealing and healing treatments,- rodenticidal baits,- use in glasshouses without pollinators.Test guidelineThe test must be carried out in accordance with EPPO Guideline 170.8.3.1.2. Bee brood feeding testAim of the testThe test should provide sufficient information to evaluate possible risks from the plant protection product on honeybee larvae.Circumstances in which requiredThe test must be carried out when the active substance may act as an insect growth regulator unless it can be justified that it is not likely that bee brood would be exposed to it.Test guidelineThe test must be carried out in accordance with ICPBR Method (e.g. P. A. Oomen, A. de Riujter and J. van der Steen. Method for honeybee brood feeding tests with insect growth-regulating insecticides. EPPO Bulletin, Volume 22, pp 613 to 616, 1992.)8.3.2. Other arethropodsAim of the testThe test should provide sufficient information to evaluate the toxicity (mortality and sublethal effects) of the active substance to selected arthropod species.Circumstances in which requiredEffects on non-target terrestrial arthropods (e.g. predators or parasitoids of harmful organisms) must be investigated. The information obtained for these species can also be used to indicate the potential for toxicity to other non-target species inhabiting the same environment. This information is required for all active substances except where preparations containing the active substance are for exclusive use in situations where non-target arthropods are not exposed such as:- food storage in enclosed spaces,- wound sealing and healing treatments,- rodenticidal baits.Test conditionsThe test must be performed initially in the laboratory on an artificial substrate (i.e. glass plate or quartz sand, as appropriate) unless adverse effects can be clearly predicted from other studies. In these cases, more realistic substrates may be used.Two sensitive standard species, a parasitoid and predatory mite (e.g. Aphidius rhopalosiphi and Typhlodromus pyri) should be tested. In addition to these, two additional species must also be tested, which should be relevant to the intended use of the substance. Where possible and if appropriate, they should represent the other two major functional groups, ground dwelling predators and foliage dwelling predators. Where effects are observed with species relevant to the proposed use of the product, further testing may be carried out at the extended laboratory/semi-field level. Selection of the relevant test species should follow the proposals outlined in Setac - Guidance document on regulatory testing procedures for pesticides with non-target arthropods (1). Testing must be conducted at rates equivalent to the highest rate of field application to be recommended.Test guidelineWhere relevant, testing should be done according to appropriate guidelines which satisfy at least the requirements for testing as included in Setac - Guidance document on regulatory testing procedures for pesticides with non-target arthropods.8.4. Effects on earthworms8.4.1. Acute toxicityAim of the testThe test should provide the LC50 value of the active substance to earthworms, where possible the highest concentration causing no mortality and the lowest concentration causing 100 % mortality, and must include observed morphological and behavioural effects.(1) From the Workshop European Standard Characteristics of beneficials Regulatory Testing (Escort), 28 to 30 March 1994, ISBN 0-95-22535-2-6.Circumstances in which requiredEffects on earthworms must be investigated, where preparations containing the active substance are applied to soil, or can contaminate soil.Test guidelineThe test must be carried out in accordance with Commission Directive 88/302/EEC (1) adapting to technical progress for the ninth time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, Part C, Toxicity for earthworms: Artificial soil test.8.4.2. Sublethal effectsAim of the testThe test should provide the NOEC and the effects on growth, reproduction and behaviour.Circumstances in which requiredWhere on the basis of the proposed manner of use of preparations containing the active substance or on the basis of its fate and behaviour in soil (DT90 > 100 days), continued or repeated exposure of earthworms to the active substance, or to significant quantities of metabolites, degradation or reaction products, can be anticipated expert judgement is required to decide whether a sublethal test can be useful.Test conditionsThe test must be carried out on Eisenia foetida.8.5. Effects on soil non-target micro-organismsAim of the testThe test should provide sufficient data to evaluate the impact of the active substance on soil microbial activity, in terms of nitrogen transformation and carbon mineralization.Circumstances in which requiredThe test must be carried out where preparations containing the active substance are applied to soil or can contaminate soil under practical conditions of use. In the case of active substances intended for use in preparations for soil sterilization, the studies must be designed to measure rates of recovery following treatment.Test conditionsSoils used must be freshly sampled agricultural soils. The sites from which soil is taken must not have been treated during the previous two years with any substance that could substantially alter the diversity and levels of microbial populations present, other than in a transitory manner.Test guidelineSetac - Procedures for assessing the environmental fate and ecotoxicity of pesticides.8.6. Effects on other non-target organisms (flora and fauna) believed to be at riskA summary of available data from preliminary tests used to assess the biological activity and dose range finding, whether positive or negative, which may provide information with respect to possible impact on other non-target species, both flora and fauna, must be provided, together with a critical assessment as to its relevance to potential impact on non-target species.8.7. Effects on biological methods for sewage treatmentEffects on biological methods for sewage treatment must be reported where the use of plant protection products containing the active substance can give rise to adverse effects on sewage treatment plants.`(1) OJ No L 133, 30. 5. 1988, p. 1.ANNEX II '10. ECOTOXICOLOGICAL STUDIESIntroduction(i) The information provided, taken together with that for the active substance(s), must be sufficient to permit an assessment of the impact on non-target species (flora and fauna), of the plant protection product, when used as proposed. Impact can result from single, prolonged or repeated exposure, and can be reversible, or irreversible.(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, to be mentioned on packaging (containers),- permit an evaluation of the short- and long-term risks for non-target species - populations, communities, and processes as appropriate,- permit an evaluation of whether special precautions are necessary for the protection of non-target species.(iii) There is a need to report all potentially adverse effects found during routine ecotoxicological investigations and to undertake and report such additional studies which may be necessary to investigate the mechanisms involved and assess the significance of these effects.(iv) In general, much of the data relating to impact on non-target species, required for authorization of plant protection products, will have been submitted and evaluated for the inclusion of the active substance(s) in Annex I. The information on fate and behaviour in the environment, generated and submitted in accordance with points 9.1 to 9.3, and on residue levels in plants generated and submitted in accordance with point 8 is central to the assessment of impact on non-target species, in that it provides information on the nature and extent of potential or actual exposure. The final PEC estimations are to be adapted according to the different groups of organisms taking in particular into consideration the biology of the most sensitive species.The toxicological studies and information submitted in accordance with point 7.1 provide essential information as to toxicity to vertebrate species.(v) 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).(vi) Whenever a study implies the use of different doses, the relationship between dose and adverse effect must be reported.(vii) Where exposure data are necessary to decide whether a study has to be performed, the data obtained in accordance with the provisions of Annex III, point 9 should be used.For the estimation of exposure of organisms 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/Council of Europe schemes for environmental risk assessment (1). Where relevant the parameters provided for in this section should be used. Where it appears from available data that the plant protection product is more toxic as the active substance, the toxicity data of the plant protection product have to be used for the calculation of relevant toxicity/exposure ratios.(viii) In the context of the influence that impurities can have on ecotoxicological behaviour, it is essential that for each study submitted, a detailed description (specification) of the material used as provided for under point 1.4, be provided.(ix) In order to facilitate the assessment of the significance of test results obtained the same strain of each relevant species should where possible be used in the various toxicity tests specified.(1) OEPP/EPPO (1993). Decision-making schemes for the environmental risk assessment of plant protection products. Bulletin OEPP/EPPO Bulletin 23, 1-154 and Bulletin 24, 1-87.10.1. Effects on birdsPossible effects on birds must be investigated except where the possibility that birds will be exposed, directly or indirectly, can be ruled out such as for use in enclosed spaces or wound healing treatments.The acute toxicity/exposure ratio (TERa), the short term dietary toxicity/exposure ratio (TERst) and the long term dietary toxicity/exposure ratio (TERlt) must be reported, where:TERa = LD50 (mg a.s./kg body weight) / ETE (mg a.s./kg body weight)TERst = LC50 (mg a.s./kg food) / ETE (mg a.s./kg food)TERlt = NOEC (mg a.s./kg food) / ETE (mg a.s./kg food)where ETE = estimated theoretical exposure.In the case of pellets, granules or treated seeds the amount of a.s. in each pellet, granule or seed must be reported as well as the proportion of the LD50 for the a.s. in 100 particles and per gram of particles. The size and shape of pellets or granules must be reported.In the case of baits the concentration of a.s. in the bait (mg/kg) must be reported.10.1.1. Acute oral toxicityAim of the testThe test should provide, where possible, LD50 values, the lethal threshold dose, time courses of response and recovery, the NOEL, and must include relevant gross pathological findings.Circumstances in which requiredThe acute oral toxicity of preparations must be reported, where TERa or TERst for the active substance(s) in birds are between 10 and 100 or where results from mammal testing give evidence of a significantly higher toxicity of the preparation compared to the active substance unless it can be justified that it is not likely that birds are exposed to the plant protection product itself.Test conditionsThe study must be conducted on the most sensitive species identified in the studies provided for in Annex II, point 8.1.1 or 8.1.2.10.1.2. Supervised cage or field trialsAim of the testThe test will provide sufficient data to evaluate the nature and the extent of the risk in practical conditions of use.Circumstances in which requiredWhere the TERa and TERst are > 100 and when there is no evidence of risk from any further study on the active substance (e.g. reproduction study) no further testing is required. In the other cases, expert judgement is necessary to decide whether there is a need to carry out further studies. This expert judgement will take into account, where relevant, foraging behaviour, repellency, alternative food, actual residue content in the food, persistence of the compound in the vegetation, degradation of the formulated product or treated produce, the amount of predation of the food, acceptance of bait, granules or treated seed and the possibility for bioconcentration.Where TERa and TERst ≤ 10 or TERlt ≤ 5, cage or field trials must be conducted and reported unless a final assessment is possible on the basis of studies according to point 10.1.3.Test conditionsBefore performing these studies the applicant should seek the agreement of the competent authorities on the type and conditions of the study to be performed.10.1.3. Acceptance of bait, granules or treated seeds by birdsAim of the testThe test will provide sufficient data to evaluate the possibility of consumption of the protection product or plant products treated with it.Circumstances in which requiredIn the case of seed dressings, pellets, baits and preparations which are granules and where TERa ≤ 10, acceptability (palatability) tests must be conducted.10.1.4. Effects of secondary poisoningExpert judgment is required to decide whether the effects of secondary poisoning should be investigated.10.2. Effects on aquatic organismsPossible effects on aquatic species must be investigated except where the possibility that aquatic species will be exposed can be ruled out.TERa and TERlt must be reported, where:TERa = acute LC50 (mg a.s./l)/realistic worst case PECsw (initial or short-term, in mg a.s./l)TERlt = chronic NOEC (mg a.s./l)/long term PECsw (mg a.s./l)10.2.1. Acute toxicity to fish, aquatic invertebrates or effects on algal growthCircumstances in which requiredIn principle tests should be carried out on one species from each of the three groups of aquatic organisms as referred to in Annex II, point 8.2 (fish, aquatic invertebrates and algae) in case the plant protection product itself can contaminate water. However where the available information permits to conclude that one of these groups is clearly more sensitive, tests on only the most sensitive species of the relevant group have to be performed.The test must be performed where:- the acute toxicity of the plant protection product can not be predicted on the basis of the data for the active substance which is especially the case if the formulation contains two or more active substances or formulants such as solvents, emulgators, surfactants, dispersants, fertilizers which are able to increase the toxicity in comparison with the active substance, or- the intended use includes direct application on waterunless suitable studies referred to under point 10.2.4 are available.Test conditions and test guidelinesThe relevant provisions as under the corresponding paragraphs of Annex II, points 8.2.1, 8.2.4 and 8.2.6 apply.10.2.2. Microcosm or mesocom studyAim of the testThe tests must provide sufficient data to evaluate the essential impact on aquatic organisms under field conditions.Circumstances in which requiredWhere TERa ≤ 100 or where TERlt ≤ 10, expert judgment must be used to decide whether a microcosm or mesocom study is appropriate. This judgment will take into account the results of any additional data over and above those required by the provisions of Annex II, point 8.2 and of point 10.2.1.Test conditionsBefore performing these studies the applicant shall seek the agreement of the competent authorities on the specific aims of the study to be performed and consequently on the type and conditions of the study to be performed.The study should include at least the highest likely exposure rate, whether from direct application, drift, drainage or run-off. The duration of the study must be sufficient to permit evaluation of all effects.Test guidelineAppropriate guidelines are included in:Setac - Guidance document on testing procedures for pesticides in freshwater mesocosms/Workshop Huntingdon, 3 and 4 July 1991orFreshwater field tests for hazard assessment of chemicals - European Workshop on Freshwater Field Tests (EWOFFT).10.2.3. Residue data in fishAim of the testThe test will provide sufficient data to evaluate the potential for occurrence of residues in fish.Circumstances in which requiredIn general data are available from bioconcentration studies in fish.Where bioconcentration has been observed in the study performed in accordance with Annex II, point 8.2.3 expert judgement is required to decide whether a long-term microcosm or mesocosm study has to be carried out in order to establish the maximum residues likely to be encountered.Test guidelineSetac - Guidance document on testing procedures for pesticides in freshwater mesocosms/Workshop Huntingdon, 3 and 4 July 1991.10.2.4. Additional studiesThe studies referred to in Annex II, points 8.2.2 and 8.2.5 may be required for particular plant protection products where it is not possible to extrapolate from data obtained in the corresponding studies on the active substance.10.3. Effects on terrestrial vertebrates other than birdsPossible effects on wild vertebrate species must be investigated except where it can be justified that it is not likely that terrestrial vertebrates other than birds are exposed, directly or indirectly. TERa, TERst and TERlt must be reported, where:TERa = LD50 (mg a.s./kg body weight) / ETE (mg a.s./kg body weight)TERst = subchronic NOEL (mg a.s./kg food) / ETE (mg a.s./kg food)TERlt = chronic NOEL (mg a.s./kg food) / ETE (mg a.s./kg food)where ETE = estimated theoretical exposure.In principle the evaluation sequence for the assessment of risks to such species is similar to that for birds. In practice it is not often necessary to perform further testing as the studies conducted in accordance with the requirements of Annex II, point 5 and Annex III, point 7 would provide the required information.Aim of the testThe test will provide sufficient information to evaluate the nature and the extent of risks for terrestrial vertebrates other than birds in practical conditions of use.Circumstances in which requiredWhere TERa and TERst > 100 and where there is no evidence of risk from any further study no further testing is required. In the other cases, expert judgment is necessary to decide whether there is a need to carry out further studies. This expert judgment will take into account, where relevant, foraging behaviour, repellency, alternative food, actual residue content in the food, persistence of the compound in the vegetation, degradation of the formulated product or treated produce, the amount of predation of the food, acceptance of bait, granules or treated seed and the possibility for bioconcentration.Where TERa and TERst ≤ 10 or TERlt ≤ 5 cage or field trials or other appropriate studies must be reported.Test conditionsBefore performing these studies the applicant shall seek the agreement of the competent authorities on the type and conditions of the study to be performed and whether the effects of secondary poisoning should be investigated.10.4. Effects on beesThe possible effects on bees must be investigated except where the product is for exclusive use in situations where bees are not likely to be exposed such as:- food storage in enclosed spaces,- non-systemic seed dressings,- non-systemic preparations for application to soil,- non-systemic dipping treatments for transplanted crops and bulbs,- wound sealing and healing treatments,- rodenticidal baits,- use in glasshouses without pollinators.The hazard quotients for oral and contact exposure (QHO and QHC), must be reported:QHO = dose/oral LD50 (ìg a.s. per bee)QHC = dose/contact LD50 (ìg a.s. per bee)wheredose = the maximum application rate, for which authorization is sought, in g of active substance per hectare.10.4.1. Acute oral and contact toxicityAim of the testThe test should provide the LD50 values (by oral and contact exposure).Circumstances in which requiredTesting is required if:- the product contains more than one active substance;- the toxicity of a new formulation cannot be reliably predicted to be either the same or lower than a formulation tested according to the provisions of Annex II, point 8.3.1.1 or of this point.Test guidelineThe test must be carried out according to EPPO Guideline 170.10.4.2. Residue testAim of the testThe test should provide sufficient information to evaluate possible risks to foraging bees from residual traces of plant protection products remaining on crops.Circumstances in which requiredWhere QHC ≥ 50, expert judgment is required to decide whether the effect of residues must be determined unless there is evidence that there are no significant residual traces remaining on crops which could affect foraging bees or unless sufficient information is available from cage, tunnel or field tests.Test conditionsThe median lethal time (LT50) (in hours) following 24-hour exposure to residues on leaves aged during eight hours must be determined, and reported. Where LT50 is more than eight hours, no further testing is required.10.4.3. Cage testsAim of the testThe test should provide sufficient information to evaluate possible risks from the plant protection product for bee survival and behaviour.Circumstances in which requiredWhere QHO and QHC are < 50, further testing is not required except if significant effects are observed in the bee brood feeding test or if there are indications for indirect effects such as delayed action or modification of bee behaviour; in those cases cage and/or field tests shall be carried out.Where QHO and QHC are > 50, cage and/or field testing is required.Where field testing is conducted and reported in accordance with point 10.4.4, it is not necessary to conduct cage tests. However, cage tests where conducted, must be reported.Test conditionsThe test should be carried out using healthy bees. If bees have been treated, e.g. with a varroacide, it is necessary to wait for four weeks before using the colony.Test guidelineThe tests must be conducted in accordance with EPPO Guideline 170.10.4.4. Field testsAim of the testThe test should provide sufficient information to evaluate possible risks from the plant protection product on bee behaviour, colony survival and development.Circumstances in which requiredField tests must be conducted where on the basis of expert judgement, taking into account the proposed manner of use and the fate and behaviour of the active substance, significant effects are observed in cage testing.Test conditionsThe test should be carried out using healthy honeybee colonies of similar natural strength. If bees have been treated, e.g. with a varroacide, it is necessary to wait for four weeks before using the colony. The tests shall be conducted under conditions reasonably representative of the proposed use.Special effects (larval toxicity, long residual effect, disorienting effects on bees) identified by the field tests may require further investigation using specific methods.Test guidelineThe tests must be conducted in accordance with EPPO Guideline 170.10.4.5. Tunnel testsAim of the testThe test should provide sufficient information to evaluate the impact on bees resulting from feeding on contaminated honey dew or flowers.Circumstances in which requiredWhere it is not possible to investigate certain effects in cage or field trials, a tunnel test should be carried out, e.g. in the case of plant protection products intended for control of aphids and other sucking insects.Test conditionsThe test should be carried out using healthy bees. If bees have been treated, e.g. with a varroacide, it is necessary to wait for four weeks before using the colony.Test guidelineThe test must be carried out in accordance with EPPO Guideline 170.10.5. Effects on arthropods other than beesThe effects of plant protection products on non-target terrestrial arthropods (e.g. predators or parasitoids of harmful organisms) must be investigated. The information obtained for these species can also be used to indicate the potential for toxicity to non-target species inhabiting the same environment.10.5.1. Laboratory, extended laboratory and semi-field testsAim of the testThe test should provide sufficient information to evaluate the toxicity of the plant protection product for selected arthropod species that are relevant to the intended use of the product.Circumstances in which requiredTesting is not required where severe toxicity ( > 99 % effect on the organisms compared to control) can be predicted from relevant available data or where the plant protection product is for exclusive use in situations where non-target arthropods are not exposed such as:- food storage in enclosed spaces,- wound sealing and healing treatments,- rodenticidal baits.Testing is required when significant effects on the organisms in comparison with the control are reported in the laboratory tests at the maximum recommended dose, conducted in accordance with the requirements of Annex II, point 8.3.2. Effects on a particular test species are considered to be significant when they exceed the threshold values as defined in the EPPO schemes for the environmental risk assessment unless species-specific threshold values are defined in the respective test guidelines.Testing is also required if:- the product contains more than one active substance,- the toxicity of a new formulation cannot be reliably predicted to be either the same or lower than a formulation tested according to the provisions of Annex II, point 8.3.2 or of this point,- on the basis of the proposed manner of use or on the basis of the fate and behaviour continued or repeated exposure can be anticipated,- there is a significant change in the proposed use, e.g. from arable crops to orchards, and species relevant to the new use have not previously been tested,- there is an increase in the recommended application rate, above that previously tested under Annex II.Test conditionsWhere significant effects were observed in the studies performed in accordance with the requirements of Annex II, point 8.3.2, or in the case of change of use such as arable crops to orchards, the toxicity of two additional relevant species must be investigated and reported. These must be different to the relevant species already tested under Annex II, point 8.3.2.For a new mixture or formulation, the toxicity should initially be assessed using the two most sensitive species as identified in studies already performed for which the threshold values were exceeded but effects still remain below 99 %. This will enable a comparison to be made; if it significantly more toxic two species relevant to its proposed use must be tested.Testing must be conducted at a rate equivalent to the maximum rate of application for which authorization is sought. A sequential testing approach should be adopted, i.e. laboratory, and if necessary extended laboratory and/or semi-field.Where there will be more than one application per season, the product should be applied at twice the recommended application rate unless this information is already available from studies performed in accordance with Annex II, point 8.3.2.Where on the basis of the proposed manner of use or on the basis of the fate and behaviour continued or repeated exposure can be anticipated (such as the product is to be applied more than three times per season with a re-application of 14 days or less), expert judgment is required to examine whether further testing is required, beyond initial laboratory testing, which will reflect the proposed use pattern. These tests may be performed in the laboratory or under semi-field conditions. When the test is done in the laboratory a realistic substrate such as plant material or a natural soil should be used. However it may be more appropriate to carry out field tests.Test guidelineWhere relevant testing should be done according to appropriate guidelines which satisfy as least the requirements for testing as included in Setac - Guidance document on regulatory testing procedures for pesticides with non-target arthropods.10.5.2. Field testsAim of the testThe tests should provide sufficient information to evaluate the risk of the plant protection product for arthropods under field conditions.Circumstances in which requiredWhere significant effects are seen following laboratory and semi-field exposure, or where on the basis of the proposed manner of use or on the basis of the fate and behaviour continued or repeated exposure can be anticipated expert judgement is required to examine whether more extensive testing is necessary to permit an accurate risk assessment.Test conditionsThe tests must be conducted under representative agricultural conditions and in accordance with the proposed recommendations for use, resulting in a realistic worst case study.A toxic standard should be included in all tests.Test guidelineWhere relevant testing should be done according to appropriate guidelines which satisfy at least the requirements for testing as included in Setac - Guidance document on regulatory testing procedures for pesticides with non-target arthropods.10.6. Effects on earthworms and other soil non-target macro-organisms, believed to be at risk10.6.1. Effects on earthwormsThe possible impact on earthworms must be reported except where it can be justified that it is not likely that earthworms are exposed, directly or indirectly.TERa and TERlt must be reported where:TERa = LC50 (mg a.s./kg)/realistic worst case PECs (initial or short-term, in mg a.s./kg)TERlt = NOEC (mg a.s./kg)/long term PECs (mg a.s./kg).10.6.1.1. Acute toxicity testsAim of the testThe test should provide the LC50, where possible the highest concentration causing no mortality and the lowest concentration causing 100 % mortality and must include observed morphological and behavioural effects.Circumstances in which requiredThese studies are only required where- the product contains more than one active substance,- the toxicity of a new formulation cannot be reliably predicted from the formulation tested according to the provisions of Annex II, point 8.4 or of this point.Test guidelineThe tests must be conducted in accordance to OECD Method 207.10.6.1.2. Tests for sublethal effectsAim of the testThe test should provide the NOEC and the effects on growth, reproduction and behaviour.Circumstances in which requiredThese studies are only required where- the product contains more than one active substance,- the toxicity of a new formulation cannot be reliably predicted from the formulation tested according to the provisions of Annex II, point 8.4 or of this point,- there is an increase in the recommended application rate, above that previously tested.Test conditionsThe same provisions as under the corresponding paragraphs of Annex II, point 8.4.2 apply.10.6.1.3. Field studiesAim of the testThe test should provide sufficient data to evaluate the effects on earthworms in field conditions.Circumstances in which requiredWhere TERlt < 5 a field study to determine effects under practical field conditions must be conducted and reported.Expert judgment is required to decide whether residue contents of earthworms should be investigated.Test conditionsFields selected shall have a reasonable earthworm population.The test must be carried out at the maximum proposed application rate. A toxic reference product must be included in the test.10.6.2. Effects on other soil non-target macro-organismsAim of the testThe test should provide sufficient data to evaluate the impact of the plant protection product on macro-organisms that contribute to the breakdown of dead plant and animal organic matter.Circumstances in which requiredTesting is not required where in accordance with Annex III, point 9.1, it is evident that DT90 values are less than 100 days, or the nature and manner of use of the plant protection product are such that exposure does not occur or when data from studies on the active substance performed in accordance with the provisions of Annex II, points 8.3.2, 8.4 and 8.5 indicate that there is no risk for soil macrofauna, earthworms or soil microflora.Impact on organic matter breakdown must be investigated and reported, where the DT90f values determined in field dissipation studies (point 9.1) are > 365 days.10.7. Effects on soil non-target micro-organisms10.7.1. Laboratory testingAim of the testThe test should provide sufficient data to evaluate the impact of the plant protection product on soil microbial activity in terms of nitrogen transformation and carbon mineralization.Circumstances in which requiredWhere the DT90f values determined in field dissipation studies (point 9.1) are > 100 days, impact on soil non-target micro-organisms must be investigated through laboratory testing. Testing is, however, not required if in the studies performed in accordance with the provisions of Annex II, point 8.5 deviations from control values in terms of metabolic activity of the microbial biomass after 100 days is < 25 %, and such data are relevant to the uses, nature, and properties of the particular preparation to be authorized.Test guidelineSetac - Procedures for assessing the environmental fate and ecotoxicity of pesticides.10.7.2. Additional testingAim of the testThe test should provide sufficient data to evaluate the impact of the plant protection product under field conditions on microbial activity.Circumstances in which requiredWhere at the end of 100 days, measured activity deviates by more than 25 % from the control, in the laboratory testing further testing in the laboratory, under glass and/or in the field may be necessary.10.8. Available data from biological primary screening in summary formA summary of available data from preliminary tests used to assess the biological activity and dose range finding whether positive or negative, which provides information with respect to possible impact on non/target species, both flora and fauna, must be provided, together with a critical assessment as to its relevance to potential impact on non-target species.11. SUMMARY AND EVALUATION OF POINTS 9 AND 10A summary and evaluation of all data presented in points 9 and 10 should be carried out according to the guidance given by the competent authorities of the Member States concerning the format of such summaries and evaluations. It should include a detailed and critical assessment of those data in the context of relevant evaluative and decision making criteria and guidelines, with particular reference to the risks for the environment and non-target species that may or do arise, and the extent, quality and reliability of the data base. In particular the following issues should be addressed:- predicting distribution and fate in the environment, and the time courses involved,- identifying non-target species and populations at risk, and predicting the extent of potential exposure,- evaluation as to the short- and long-term risks for non-target species - populations, communities, and processes - as appropriate,- evaluation as to the risk of fish kills, and fatalities in large vertebrates, or terrestrial predators, regardless of effects at population or community level, and- identification of precautions necessary to avoid or minimize contamination of the environment, and for the protection of non-target species.`


Avis juridique important

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31991L0477

Council Directive 91/477/EEC of 18 June 1991 on control of the acquisition and possession of weapons

Official Journal L 256 , 13/09/1991 P. 0051 - 0058 Finnish special edition: Chapter 15 Volume 10 P. 0145  Swedish special edition: Chapter 15 Volume 10 P. 0145

COUNCIL DIRECTIVE  of 18 June 1991  on control of the acquisition and possession of weapons  (91/477/EEC)THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,  Having regard to the proposal from the Commission (1),  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Article 8a of the Treaty provides that the internal market must be established by not later than 31 December 1992; whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services  and capital is ensured, in accordance with the provisions of the Treaty;  Whereas, at its meeting in Fontainebleau on 25 and 26 June 1984, the European Council expressly set the objective of abolishing all police and customs formalities at intra-Community frontiers;  Whereas the total abolition of controls and formalities at intra-Community frontiers entails the fulfilment of certain fundamental conditions; whereas in its white paper 'Completing the internal market' the Commission stated that the abolition of  controls on the safety of objects transported and on persons entails, among other things, the approximation of weapons legislation;  Whereas abolition of controls on the possession of weapons at intra-Community frontiers necessitates the adoption of effective rules enabling controls to be carried out within Member States on the acquisition and possession of firearms and on their  transfer to another Member State; whereas systematic controls must therefore be abolished at intra-Community frontiers;  Whereas the mutual confidence in the field of the protection of the safety of persons which these rules will generate between Member States will be the greater if they are underpinned by partially harmonized legislation; whereas it would therefore be  useful to determine category of firearms whose acquisition and possession by private persons are to be prohibited, or subject to authorization, or subject to declaration;  Whereas passing from one Member State to another while in possession of a weapon should, in principle, be prohibited; whereas a derogation therefrom is acceptable only if a procedure is adopted that enables Member States to be notified that a firearm is  to be brought into their territory;  Whereas, however, more flexible rules should be adopted in respect of hunting and target shooting in order to avoid impeding the free movement of persons more that is necessary;  Whereas the Directive does not affect the right of Member States to take measures to prevent illegal trade in weapons,  HAS ADOPTED THIS DIRECTIVE:  CHAPTER 1  Scope   Article 1  1. For the purposes of this Directive 'weapons' and 'firearms' shall have the meanings ascribed to them in Annex I. Firearms are classified and defined in section II of that Annex.  2. For the purposes of this Directive 'dealer' shall mean any natural or legal person whose trade or business consists wholly or partly in the manufacture, trade, exchange, hiring out, repair or conversion of firearms.  3. For the purposes of this Directive, a person shall be deemed to be a resident of the country indicated by the address appearing on a document establishing his place of residence, such as a passport or an identity card, which, on a check on possession  or on acquisition, is submitted to the authorities of a Member State or to a dealer.  4. The 'European firearms pass' is a document which is issued on request by the authorities of a Member State to a person lawfully entering into possession of and using a firearm. It shall be valid for a maximum period of five years. The period of  validity may be extended. Where only firearms classified in category D appear on the pass, the maximum period of validity thereof shall be ten years. It shall contain the information set out in Annex II. The 'European firearms pass' is a  non-transferable document, on which shall be entered the firearm or firearms possessed and used by the holder of the pass. The pass must always be in the possession of the person using the firearm. Changes in the possession or characteristics of the  firearms shall be indicated on the pass, as well as the loss or theft of the firearm.  Article 2  1. This Directive is without prejudice to the application of national provisions concerning the carrying of weapons, hunting or target shooting.  2. This Directive shall not apply to the acquisition or possession of weapons and ammunition, in accordance with national law, by the armed forces, the police, the public authorities or by collectors and bodies concerned with the cultural and historical  aspects of weapons and recognized as such by the Member State in whose territory they are established. Nor shall it apply to commercial transfers of weapons and ammunition of war.  Article 3  Member States may adopt in their legislation provisions which are more stringent than those provided for in this Directive, subject to the rights conferred on residents of the Member States by Article 12 (2).  CHAPTER 2 Harmonization of legislation concerning firearms   Article 4  At least in respect of categories A and B, each Member State shall make the pursuit of the activity of dealer within its territory conditional upon authorization on the basis of at least a check on the private and professional integrity of  the dealer. In the case of a legal person, the check shall be on the person who directs the undertaking. In respect of categories C and D, each Member State which does not make the pursuit of the activity of dealer conditional upon authorization shall  make such activity subject to a declaration.  Each dealer shall be required to keep a register in which information concerning all firearms classified in category A, B or C received or disposed of by him shall be recorded, including such particulars as enable the weapon to be identified, in  particular the type, make, model, calibre and serial number thereof and the names and addresses of the supplier and the person acquiring the weapon. The Member States shall regularly check dealers' compliance with this obligation. The dealer shall  conserve the register for a period of five years, even after he has ceased his activity.  Article 5  Without prejudice to Article 3, Member States shall allow the acquisition and possession of firearms classified in category B only by persons who have good cause and who:  (a) are 18 years old or more, except for hunting or target shooting;  (b) are not likely to be a danger to themselves, to public order or to public safety.  Without prejudice to Article 3, Member States shall allow the possession of firearms classified in categories C and D only by persons satisfying the conditions in point (a) of the first paragraph.  Member States may withdraw authorization for possession of the firearm if any of the conditions in point (b) of the first paragraph is no longer satisfied.  Member States may not prohibit persons resident within their territories from possessing a weapon acquired in another Member State unless they prohibit the acquisition of the same weapon within their own territories.  Article 6  Member States shall take all appropriate steps to prohibit the acquisition and the possession of the firearms and ammunition classified in category A. In special cases, the competent authorities may grant authorizations for such firearms and  ammunition where this is not contrary to public security or public order.  Article 7  1. No one may acquire a firearm classified in category B within the territory of a Member State unless that Member State has so authorized him.  No such authorization may be given to a resident of another Member State without the latter's prior agreement.  2. No one may be in possession of a firearm classified in category B within the territory of a Member State unless that Member State has so authorized him. If he is a resident of another Member State, that other Member State shall be informed  accordingly.  3. An authorization to acquire and an authorization to possess a firearm classified in category B may take the form of a single administrative decision.  Article 8  1. No one may be in possession of a firearm classified in category C unless he has declared it to the authorities of the Member State in which that firearm is held.  The Member States shall provide for the compulsory declaration of all firearms classified in category C at present held within their territories but not previously declared within one year of the entry into force of the national provisions transposing  this Directive.  2. Every seller, dealer or private person shall inform the authorities of the Member State in which it takes place of every transfer or handing over of a firearm classified in category C, giving the particulars by which the firearm and the person  acquiring it may be identified. If the person acquiring such a firearm is a resident of another Member State, that other Member State shall be informed of the acquisition by the Member State in which it took place and by the person acquiring the  firearm.  3. If a Member State prohibits or makes subject to authorization the acquisition and possession within its territory of a firearm classified in category B, C or D, it shall so inform the other Member States, which shall expressly include a statement to  that effect on any European firearms pass they issue for such a firearm, pursuant to Article 12 (2).  Article 9  1. The handing over of a firearm classified in category A, B or C to a person who is not resident in the Member State in question shall be permitted, subject to compliance with the obligations laid down in Articles 6, 7 and 8:  - where the person acquiring it has been authorized in accordance with Article 11 himself to effect a transfer to his country of residence,  - where the person acquiring it submits a written declaration testifying to and justifying his intention to be in possession of the firearm in the Member State of acquisition, provided that he fulfils the legal conditions for possession in that Member  State.  2. Member States may authorize the temporary handing over of firearms in accordance with procedures which they shall lay down.  Article 10  The arrangements for the acquisition and possession of ammunition shall be the same as those for the possession of the firearms for which the ammunition is intended.  CHAPTER 3 Formalities for the movement of weapons within the Community   Article 11  1. Firearms may, without prejudice to Article 12, be transferred from one Member State to another only in accordance with the procedure laid down in the following paragraphs. These provisions shall also apply to transfers of firearms  following a mail order sale.  2. Where a firearm is to be transferred to another Member State, the person concerned shall, before it is taken there, supply the following particulars to the Member State in which such firearm is situated:  - the names and addresses of the person selling or disposing of the firearm and of the person purchasing or acquiring it or, where appropriate, of the owner,  - the address to which the firearm is to be consigned or transported,  - the number of firearms to be consigned or transported,  - the particulars enabling the firearm to be identified and also an indication that the firearm has undergone a check in accordance with the Convention of 1 July 1969 on the Reciprocal Recognition of Proofmarks on Small Arms,  - the means of transfer,  - the date of departure and the estimated date of arrival.  The information referred to in the last two indents need not be supplied where the transfer takes place between dealers.  The Member State shall examine the conditions under which the transfer is to be carried out, in particular with regard to security.  Where the Member State authorizes such transfer, it shall issue a licence incorporating all the particulars referred to in the first subparagraph. Such licence shall accompany the firearm until it reaches its destination; it shall be produced whenever  so required by the authorities of the Member States.  3. In the case of transfer of the firearms, other than weapons of war, excluded from the scope of this Directive pursuant to Article 2 (2), each Member State may grant dealers the right to effect transfers of firearms from its territory to a dealer  established in another Member State without the prior authorization referred to in paragraph 2. To that end it shall issue an authorization valid for no more than three years, which may at any time be suspended or cancelled by reasoned decision. A  document referring to that authorization must accompany the firearm until it reaches its destination; it must be produced whenever so required by the authorities of the Member States.  Not later than the time of transfer, the dealer shall communicate to the authorities of the Member State from which the transfer is to be effected all the particulars listed in the first subparagraph of paragraph 2.  4. Each Member State shall supply the other Member States with a list of firearms the transfer of which to its territory may not be authorized without its prior consent.  Such lists of firearms shall be communicated to dealers who have obtained approval for transferring firearms without prior authorization under the procedure laid down in paragraph 3.  Article 12  1. If the procedure provided for in Article 11 is not employed, the possession of a firearm during a journey through two or more Member States shall not be permitted unless the person concerned has obtained the authorization of each of those  Member States.  Member States may grant such authorization for one or more journeys for a maximum period of one year, subject to renewal. Such authorizations shall be entered on the European firearms pass, which the traveller must produce whenever so required by the  authorities of the Member States.  2. Notwithstanding paragraph 1, hunters, in respect of categories C and D, and marksmen, in respect of category B, C and D, may without prior authorization be in possession of one or more firearms classified in these categories during a journey through  two or more Member States with a view to engaging in their activities, provided that they are in possession of a European firearms pass listing such firearm or firearms and provided that they are able to substantiate the reasons for their journey, in  particular by producing an invitation.  However, this derogation shall not apply to journeys to a Member State which prohibits the acquisition and possession of the firearm in question or which, pursuant to Article 8 (3), makes it subject to authorization; in that case, an express statement  to that effect shall be entered on the European firearms pass.  In the context of the report referred to in Article 17, the Commission in consultation with the Member States, will also consider the effects of applying the second subparagraph, particularly as regards its impact on public order and public security.  3. Under agreements for the mutual recognition of national documents, two or more Member States may provide for arrangements more flexible than those prescribed in this Article for movement with firearms within their territories.  Article 13  1. Each Member State shall communicate all useful information at its disposal concerning definitive transfers of firearms to the Member State to the territory of which such a transfer has been effected.  2. All information that Member States receive by way of the procedures laid down in Article 11 for transfers of firearms and in Article 7 (2) and Article 8 (2) for the acquisition and possession of firearms by non-residents shall be communicated, not  later than the time of the relevant transfers, to the Member States of destination and, where appropriate, not later than the time of transfer to the Member States of transit.  3. Member States shall set up, by 1 January 1993 at the latest, networks for the exchange of information for the purposes of applying this Article. They shall inform the other Member States and the Commission of the national authorities responsible for  transmitting and receiving information and for applying the formalities referred to in Article 11 (4).  Article 14  Member States shall adopt all relevant provisions prohibiting entry into their territory:  - of a firearm except in the cases defined in Articles 11 and 12 and provided the conditions laid down therein are met,  - of a weapon other than a firearm provided that the national provisions of the Member State in question so permit.  CHAPTER 4 Final provisions   Article 15  1. Member States shall intensify controls on the possession of weapons at external Community frontiers. They shall in particular ensure that travellers from third countries who intend to proceed to another Member State comply with Article  12.  2. This Directive shall not preclude the carrying out of controls by Member States or by the carrier at the time of boarding of a means of transport.  3. Member States shall inform the Commission of the manner in which the controls referred to in paragraphs 1 and 2 are carried out. The Commission shall collate this information and make it available to all Member States.  4. Member States shall notify the Commission of their national provisions, including changes relating to the acquisition and possession of weapons, where the national law is more stringent than the minimum standard they are required to adopt. The  Commission shall pass on such information to the other Member States.  Article 16  Member States shall introduce penalties for failure to comply with the provisions adopted pursuant to this Directive. Such penalties must be sufficient to promote compliance with such provisions.  Article 17  Within five years from the date of transposition of this Directive into national law, the Commission shall submit a report to the European Parliament and to the Council on the situation resulting from the application of this Directive,  accompanied, if appropriate, by proposals.  Article 18  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive in good time so that the measures provided for by this Directive may be put into effect not later than 1 January  1993. They shall forthwith inform the Commission and the other Member States of the measures taken.  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 a reference shall be laid down by the Member  States.  Article 19  This Directive is addressed to the Member States. Done at Luxembourg, 18 June 1991. For the Council  The President  G. WOHLFART   (1) OJ No C 235, 1. 9. 1987, p. 8 and OJ No C 299, 28. 11. 1989, p. 6. (2) OJ No C 231, 17. 9. 1990, p. 69 and OJ No C 158, 17. 6. 1991, p. 89. (3) OJ No C 35, 8. 2. 1988, p. 5.    ANNEX I I. For the purposes of this Directive, 'weapon' means:  - any firearm as defined in section II of this Annex,  - weapons other than firearms as defined in national legislation.  II. For the purposes of this Directive, 'firearm' means:  A. Any object which falls into one of the following categories, unless it meets the definition but is excluded for one of the reasons listed in section III.  Category A - Prohibited firearms  1. Explosive military missiles and launchers.  2. Automatic firearms.  3. Firearms disguised as other objects.  4. Ammunition with penetrating, explosive or incendiary projectiles, and the projectiles for such ammunition.  5. Pistol and revolver ammunition with expanding projectiles and the projectiles for such ammunition, except in the case of weapons for hunting or for target shooting, for persons entitled to use them.  Category B - Firearms subject to authorization  1. Semi-automatic or repeating short firearms.  2. Single-shot short firearms with centre-fire percussion.  3. Single-shot short firearms with rimfire percussion whose overall length is less than 28 cm.  4. Semi-automatic long firearms whose magazine and chamber can together hold more than three rounds.  5. Semi-automatic long firearms whose magazine and chamber cannot together hold more than three rounds, where the loading device is removable or where it is not certain that the weapon cannot be converted, with ordinary tools, into a weapon whose  magazine and chamber can together hold more than three rounds.  6. Repeating and semi-automatic long firearms with smooth-bore barrels not exceeding 60 cm in length.  7. Semi-automatic firearms for civilian use which resemble weapons with automatic mechanisms.  Category C - Firearms subject to declaration  1. Repeating long firearms other than those listed in category B, point 6.  2. Long firearms with single-shot rifled barrels.  3. Semi-automatic long firearms other than those in category B, points 4 to 7.  4. Single-shot short firearms with rimfire percussion whose overall length is not less than 28 cm.  Category D - Other firearms  Single-shot long firearms with smooth-bore barrels.  B. Any essential component of such firearms:  The breach-closing mechanism, the chamber and the barrel of a firearm which, being separate objects, are included in the category of the firearms on which they are or are intended to be mounted.  III. For the purposes of this Annex objects which correspond to the definition of a 'firearm' shall not be included in that definition if they:  (a) have been rendered permanently unfit for use by the application of technical procedures which are guaranteed by an official body or recognized by such a body;  (b) are designed for alarm, signalling, life-saving, animal slaughter or harpoon fishing or for industrial or technical purposes provided that they can be used for the stated purpose only;  (c) are regarded as antique weapons or reproductions of such where these have not been included in the previous categories and are subject to national laws.  Pending coordination throughout the Community, Member States may apply their national laws to the firearms listed in this Section.  IV. For the purposes of this Annex:  (a) 'short firearm' means a firearm with a barrel not exceeding 30 centimetres or whose overall length does not exceed 60 centimetres;  (b) 'long firearm' means any firearm other than a short firearm;  (c) 'automatic firearm' means a firearm which reloads automatically each time a round is fired and can fire more than one round with one pull on the trigger;  (d) 'semi-automatic firearm' means a firearm which reloads automatically each time a round is fired and can fire only one round with one pull on the trigger;  (e) 'repeating firearm' means a firearm which after a round has been fired is designed to be reloaded from a magazine or cylinder by means of a manually-operated action;  (f) 'single-shot firearm' means a firearm with no magazine which is loaded before each shot by the manual insertion of a round into the chamber or a loading recess at the breech of the barrel;  (g) 'ammunition with penetrating projectiles' means ammunition for military use where the projectile is jacketed and has a penetrating hard core;  (h) 'ammunition with explosive projectiles' means ammunition for military use where the projectile contains a charge which explodes on impact;  (i) 'ammunition with incendiary projectiles' means ammunition for military use where the projectile contains a chemical mixture which bursts into flame on contact with the air or on impact.     ANNEX II EUROPEAN FIREARMS PASS  The pass must include the following sections:  (a) identity of the holder;  (b) identification of the weapon or firearm, including a reference to the category within the meaning of the Directive;  (c) period of validity of the pass;  (d) section for use by the Member State issuing the pass (type and references of authorizations, etc.);  (e) section for entries by other Member States (authorizations to enter their territory, etc.);  (f) the statements:  'The right to travel to another Member State with one or more of the firearms in categories B, C or D mentioned in this pass shall be subject to one or more prior corresponding authorizations from the Member State visited. This or these authorizations  may be recorded on the pass.  The prior authorization referred to above is not in principle necessary in order to travel with a firearm in categories C or D with a view to engaging in hunting or with a firearm in categories B, C or D for the purpose of taking part in target  shooting, on condition that the traveller is in possession of the firearms pass and can establish the reason for the journey.'  Where a Member State has informed the other Member States, in accordance with Article 8 (3), that the possession of certain firearms in categories B, C or D is prohibited or subject to authorization, one of the following statements shall be added:  'A journey to . . . (State(s) concerned) with the firearm . . . (identification) shall be prohibited.'  'A journey to . . . (State(s) concerned) with the firearm . . . (identification) shall be subject to authorization.'


Avis juridique important

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31986L0547

Third Commission Directive 86/547/EEC of 29 October 1986 amending Annex III B to Council Directive 77/93/EEC on protective measures against the introduction into the Member States of organisms harmful to plants or plant products

Official Journal L 323 , 18/11/1986 P. 0021 - 0024

*****THIRD  COMMISSION DIRECTIVE  of 29 October 1986  amending Annex III B to Council Directive 77/93/EEC on protective measures against the introduction into the Member States of organisms harmful to plants or plant products  (86/547/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Member States of organisms harmful to plants or plant products (1), as last amended by Regulation (EEC) No 3768/85 (2), and in particular Article 13, paragraph two, indent one thereof,  Having regard to the requests made by Greece, Spain, France, Ireland, Italy, Portugal and the United Kingdom,  Whereas Directive 77/93/EEC laid down protective measures against the introduction into the Member States of organisms harmful to plants or plant products; whereas those measures include measures to be taken by Member States in respect of plants, plant products and other objects coming from third countries;  Whereas certain Member States have stricter measures in respect of those plants and plant products;  Whereas those stricter measures include, in the requesting Member States, prohibitions of certain products originating in a third country;  Whereas, if Annex III to the aforementioned Directive is amended appropriately, the Member States concerned could also impose the relevant prohibitions where the products concerned, originating in a third country, come from other Member States;  Whereas, following the intentions declared by the Commission and all Member States at the time of adoption amending Council Directive 85/574/EEC (3), Annex III (B) to Directive 77/93/EEC should be amended accordingly, as an interim protective measures for a period of three years;  Whereas during that period the Commission will study these protective measures in relation to the plant health situation existing in the various third countries concerned, in order to arrive, at the end of the period, at more permanent provisions;  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  In Annex III B to Directive 77/93/EEC the following are hereby added:  1.2 //  //  //  //  // '11. Plants of the following genera, other than seeds, originating in third countries where Erwinia amylovora is known to occur; Chaenomeles Lindl., Cydonia Mill., Malus Mill, Pyracantha M.J. Roem, Pyrus L., Sorbus L., Stranvaesia   // Greece, Spain, Portugal   // 12. Plants vine (Vitis L. partim) and any other plant which can be a vector of the organism causing Pierce's disease, originating in the USA (states where Pierce's disease is known to occur) or other third countries where Pierce's disease is known to occur  // Greece, Portugal  1.2 //  //  //  //  // 13. Plants of vine (Vitis L. partim), other than fruit and seeds, originating in third countries  // Spain, France   // 14. Fruits of the genera Cydonia Mill., Malus Mill., Prunus L., Pyrus L., Ribes L. and other fruits primarily grown in tropical regions, originating in non-European countries where relevant fruit-infesting Trypetidae (non-European) are known to occur   // Spain, Portugal   // 15. Without prejudice to the prohibitions applicable to plants under points 9 and 10, plants of Chaenomeles Lindl., Cydonia Mill., Malus Mill., Pyracantha M.J. Roem, Pyrus L., Sorbus L. and Stranvaesia, other than fruit and seeds, originating in third countries   // Ireland   // 16. Without prejudice to the prohibitions applicable to plants under Annex III A: plants of the order Coniferales other than seeds, originating in third countries   // Ireland   // 17. Plants, other than seeds, of Apium L., Beta L., Brassica L., Cichorium L., Cynara, Daucus L., Foeniculum Mill., Lactuca L., Nasturtium officinale R. Br., Petroselinum Hill, Raphanus L. and Spinaceae with foliage, originating in third countries  // Ireland   // 18. Plants and plant products with growing medium attached, originating in third countries   // Ireland  // 19. Wood chips and sawdust originating in third countries  // Ireland   // 20. Plants of the following genera, other than seeds, originating in third countries: Acacia Tourn., ex I., Acer L., Med., Chaenomeles Lindl., Cydonia Mill., Fagus L., Malus Mill., Populus L., Prunus L., Pyracantha M.R. Roem, Pyrus L., Rosa L., Salix L., Sorbus L., Stranvaesia, Ulmus L., Vitis L.   // Italy   // 21. Plants of Fragaria, other than fruit and seeds originating in non-European countries   // Italy   // 22. From 1 April to 30 November plants of Solanaceae, other than tubers and seeds, originating in third countries   // Italy  // 23. From 1 April to 30 November fruit of melon and water-melon, originating in non-European countries   // Italy  // 24. From 1 June to 30 November fruits of Ananas originating in third countries   // Italy   // 25. Plants of Solanaceae for planting, other than tubers of potatoes and seeds, other than from European or Mediterranean countries   // United Kingdom  //  //  //  // 26. Annual and biennial plants for planting, other than seeds, other than from European or Mediterranean countries   // United Kingdom   // 27. Plants of Beta L. for planting originating in third countries   // United Kingdom  // 28. Plants of Dendranthema (DC.) Desmoul. for planting, other than seeds, originating in third countries   // United Kingdom   // 29. Plants of Gramineae for planting, other than seeds, originating in third countries   // United Kingdom  // 30. Herbaceous perennial plants, for planting, of Caryophyllaceae, Compositae, Cruciferae, Leguminosae and Rosaceae, other than seeds, other than plants of Dianthus caryophyllus L., Dendranthema (DC.) Desmoul. and Fragaria L., other than from European or Mediterranean countries   // United Kingdom   // 31. Plants of Cydonia Mill, Malus Mill, Prunus L., and Pyrus L. for planting, other than seeds, originating in third countries other than Algeria, Egypt, Finland, Israel, Libya, Morocco, Norway, Sweden and Tunisia   // United Kingdom  // 32. Plants of Fragaria L. for planting, other than seeds, originating in non-European countries other than African states, Australia, Canada, Cyprus, Israel, Lebanon, New Zealand, Syria, Turkey and Continental States of the United States of America   // United Kingdom   // 33. Plants of trees and shrubs for planting, other than seeds, other than plants of certain families intended for use as indoor or glasshouse ornamentals, other than from European or Mediterranean countries and other than Canada and Continental States of the United States of America   // United Kingdom   // 34. Soil originating in third countries   // United Kingdom   // 35. Potato tubers for planting from third countries, other than those originating in Austria or Switzerland officially certified as seed potatoes pursuant to Directive 66/403/EEC  // United Kingdom   // 36. Potato tubers for consumption originating in third countries, other than Algeria, Austria, Cyrus, Egypt, Israel, Libya, Malta, Morocco, Switzerland and Tunisia   // United Kingdom  //  //  //  // 37. Seeds of Medicago sativa L., for planting, originating in third countries where Corynebacterium michiganense pv insidiosum is known to occur, other than Australia, Austria, Canada, Czechoslovakia, Finland, Israel, Romania, Republic of South Africa, Sweden and the United States of America   // United Kingdom   // 38. Plants of Castanea Mill., Larix Mill., Populus L. with or without leaves, Pseudotsuga Carr., Quercus L., Tsuga Carr. and Ulmus L., other than fruit and seeds originating in non-European countries  // United Kingdom   // 39. Plants of Zelkova Spach originating in non-European countries   // Ireland, United Kingdom (Northern Ireland)   // 40. Isolated bark of conifers (Coniferae) originating in third countries   // Ireland, Portugal, United Kingdom'.   //   //  Article 2  Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive. Member States shall immediately inform the Commission of all laws, regulations and administrative provisions adopted in implementation of this Directive. The Commission shall inform the other Member States thereof.  Article 3  This Directive shall apply until 31 December 1989.  Article 4  This Directive is addressed to the Member States.  Done at Brussels, 29 October 1986.  For the Commission  Frans ANDRIESSEN  Vice-President  (1) OJ No L 26, 31. 1. 1977, p. 20.  (2) OJ No L 362, 31. 12. 1985, p. 8.  (3) OJ No L 372, 31. 12. 1985, p. 25.