Avis juridique important

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31996L0068

Commission Directive 96/68/EC of 21 October 1996 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)

Official Journal L 277 , 30/10/1996 P. 0025 - 0034

COMMISSION DIRECTIVE 96/68/EC of 21 October 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 96/46/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 and for the authorization of a plant protection product;Whereas it is necessary to indicate, to the applicants, in Annexes II and III, 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 residues in or on treated products, food and feed of the active substance provided for in Section 6 of Part A of Annex II;Whereas it is also now possible to introduce more precision with regard to the data requirements concerning residues in or on treated products, food and feed of the plant protection product provided for in Section 8 of Part A of Annex III;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 '6. Residues in or on treated products, food and feed` is replaced by Annex I hereto.2. In Part A of Annex III in Section 7, under the heading '7.2. Data on exposure` the following text is inserted:'When measuring exposure to a plant protection product in the air within the breathing area of operators, bystanders or workers the requirements for measuring procedures described in Annex II A to Council Directive 80/1107/EEC of 27 November 1980 on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work (*) have to be taken into account.(*) OJ No L 327, 3. 12. 1980, p. 8.`3. In Part A of Annex III the Section headed '8. Residues in or on treated products, food and feed` is 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 not later than 30 November 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 Member States.Article 3 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.Article 4 This Directive is addressed to the Member States.Done at Brussels, 21 October 1996.For the CommissionFranz FISCHLERMember of the Commission(1) OJ No L 230, 19. 8. 1991, p. 1.(2) OJ No L 214, 23. 8. 1996, p. 18.ANNEX I Section 6 of Part A of Annex II to Directive 91/414/EEC is replaced by the following:'6. RESIDUES IN OR ON TREATED PRODUCTS, FOOD AND FEEDIntroduction(i) The information provided, taken together with that provided for one or more preparations containing the active substance, must be sufficient to permit an evaluation to be made as to the risks for man, arising from residues of the active substance and relevant metabolites, degradation and reaction products remaining in food. In addition, the information provided must be sufficient to:- permit a decision to be made as to 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.(ii) A detailed description (specification) of the material used, as provided under Section 1, point 11 must be provided.(iii) Studies should be performed according to the guidance available on regulatory testing procedures for residues of plant protection products in food (*).(iv) Where relevant, data should be analyzed using appropriate statistical methods. Full details of the statistical analysis should be reported.(v) Stability of residues during storage.If may be necessary to perform studies on the stability of residues during storage. Provided samples are frozen within generally 24 hours after sampling and unless a compound is otherwise known to be volatile or labile, data are not normally required for samples extracted and analysed within 30 days from sampling (six months in the case of radio-labelled material).Studies with non-radio-labelled substances should be carried out with representative substratets and preferably on samples from treated crops or animals with incurred residues. Alternatively, if this is not possible, aliquots of prepared control samples should be spiked with a known amount of chemical before storage under normal storage conditions.Where the degradation during storage is significant (more than 30 %) it may be necessary to change the storage conditions or not to store the samples prior to analysis and repeat and studies where the unsatisfactory storage conditions were used.Detailed information with respect to the sample preparation and storage conditions (temperature and duration) of samples and extracts must be submitted. Storage stability data using sample extracts will also be required unless samples are analysed within 24 hours of extraction.6.1. Metabolism, distribution and expression of residue in plantsAim of the testsThe objectives of these studies are:- to provide an estimate of total terminal residues in the relevant portion of crops at harvest following treatment as proposed,- to identify the major components of the total terminal residue,- to indicate the distribution of residues between relevant crops parts,- to quantify the major components of the residue and to establish the efficiency of extraction procedures for these components,- to decide on the definition and expression of a residue.Circumstances in which requiredThese studies must always be performed unless it can be justified that no residues will remain on plants/plant products which are used as food or feedingstuffs.(*) Guidance under development.Test conditionsMetabolism studies have to involve crops or categories of crops in which plant protection products containing the active substance in question would be used. If a wide range of uses in different crop categories or in the category fruits is envisaged, studies have to be carried out on at least three crops unless it can be justified that a different metabolism is unlikely to occur. In cases where use is envisaged in different categories of crops, the studies must be representative for the relevant categories. For this purpose crops can be considered as falling into one of five categories: root vegetables, leafy crops, fruits, pulses and oilseeds, cereals. If studies are available for crops from three of these categories and the results indicate that the route of degradation is similar in all three categories then it is unlikely that any more studies will be needed unless it could be expected that a different metabolism will occur. The metabolism studies have also to take into account the different properties of the active substance and the intended method of application.An evaluation of the results from different studies has to be submitted on the point and path of uptake (e.g. via leaves or roots), and on the distribution of residues between relevant parts of the crop at harvest (with particular emphasis on edible parts for man or animals). If the active substance or relevant metabolites are not taken up by the crop, this must be explained. Information on the mode of action and the physico-chemical properties of the active substance may be helpful in assessing trial data.6.2. Metabolism, distribution and expression of residue in livestockAim of testsThe objectives of these studies are:- to identify the major components of the total terminal residue in edible animal products,- to quantify the rate of degradation and excretion of the total residue in certain animal products (milk or eggs) and excreta,- to indicate the distribution of residues between relevant edible animal products,- to quantify the major components of the residue and to show the efficiency of extraction procedures for these components,- to generate data from which a decision on the need for livestock feeding studies as provided for in point 6.4 can be made,- to decide on the definition and expression of a residue.Circumstances in which requiredMetabolism studies on animals, such as lactating ruminants (e.g. goat or cow) or laying poultry, are only required when pesticide use may lead to significant residues in livestock feed (≥ 0,1 mg/kg of the total diet as received, except special cases e.g. active substances which accumulate). Where it becomes apparent that metabolic pathways differ significantly in the rat as compared to ruminants a pig study must be conducted unless the expected intake by pigs is not significant.6.3. Residue trialsAim of the testsThe objectives of these studies are:- to quantify the highest likely residue levels in treated crops at harvest or outloading from store following the proposed good agricultural practice (GAP),and- to determine, when appropriate, the rate of decline of plant protection product deposits.Circumstances in which requiredThese studies must always be performed where the plant protection product will be applied to plants/plant products which are used as food or feedingstuffs or where residues from soil or other substrates can be taken up by such plants except where extrapolation from adequate data on another crop is possible.Residue trial data shall be submitted in the Annex II dossier for those uses of plant protection products for which authorization is sought at the moment of introduction of a dossier for inclusion of the active substance in Annex I.Test conditionsSupervised trials should correspond to proposed critical GAP. The test conditions must take into account the highest residues which may reasonably arise (e.g. maximum number of proposed applications, use of the maximum envisaged quantity, shortest pre-harvest intervals, withholding periods or storage periods) but which remain representative of the realistic worst case conditions in which the active substance would be used.Sufficient data must be generated and submitted to confirm that patterns determined hold for the regions and the range of conditions, likely to be encountered in the regions concerned for which its use is to be recommended.When establishing a supervised trial programme, normally factors such as climatic differences existing between production areas, differences in production methods (e.g. outdoor versus glasshouse uses), seasons of production, type of formulations, etc. should be taken into account.In general, for a comparable set of conditions, trials should be carried out over a minimum of two growing seasons. All exceptions should be fully justified.The precise number of trials necessary is difficult to determine in advance of a preliminary evaluation of the trial results. Minimum data requirements only apply where comparability can be established between production areas, e.g. concerning climate, methods and growing seasons of production, etc. Assuming all other variables (climate, etc.) are comparable, a minimum of eight trials representative of the proposed growing area is required for major crops. For minor crops normally four trials representative of the proposed growing area are required.Due to the inherently higher level of homogeneity in residues arising from post-harvest treatments or protected crops, trials from one growing season will be acceptable. For post-harvest treatments, in principle a minimum of four trials are required, carried out preferably at different locations with different cultivars. A set of trials has to be carried out for each application method and store type unless the worst case residue situation can be clearly identified.The number of studies per growing season to be performed can be reduced if it can be justified that the residue levels in plants/plant products will be lower than the limit of determination.Where a significant part of the consumable crop is present at the time of application, half of the supervised residue trials reported should include data to show the effect of time on the level of residue present (residue decline studies) unless it can be justified that the consumable crop is not affected by the application of the plant protection product under the proposed conditions of use.6.4. Livestock feeding studiesAim of the testsThe objective of these studies is to determine the residue in products of animal origin which will result from residues in feedingstuffs or fodder crops.Circumstances in which requiredFeeding studies are only required:- when significant residues (≥ 0,1 mg/kg of the total diet as received, except special cases, such as active substances which accumulate) occur in crops or part of the crop (e.g. trimmings, waste) fed to animals, and- when metabolism studies indicate that significant residues (0,01 mg/kg or above the limit of determination if this would be higher than 0,01 mg/kg) may occur in any edible animal tissue taking into account the residue levels in potential feedingstuffs obtained at the 1× dose rate.Where appropriate separate feeding studies for lactating ruminant and/or laying poultry should be submitted. Where it appears from the metabolism studies submitted in accordance with the provisions of point 6.2 that metabolic pathways differ significantly in the pig as compared to ruminants, a pig feeding study must be conducted unless the expected intake by pigs is not significant.Test conditionsIn general, the feed is administered in three dosages (expected residue level, three to five times, and 10 times the expected residue level). When setting the 1× dose, a theoretical feed ration must be compiled.6.5. Effects of industrial processing and/or household preparationsCircumstances in which requiredThe decision as to whether it is necessary to carry out processing studies will depend on:- the importance of a processed product in the human or animal diet,- the level of residue in the plant or plant product to be processed,- the physico-chemical properties of the active substance or relevant metabolites, and- the possibility that degradation products of toxicological significance may be found after processing of the plant or plant product.Processing studies are not normally necessary if no significant or no analytically determinable residues occur in the plant or plant product which would be processed, or if the total theoretical maximum daily intake (TMDI) is less than 10 % of the ADI. In addition, processing studies are not normally required for plants or plant products mostly eaten raw except for those with inedible portions such as citrus, banana or kiwi fruit where data on the distribution of the residue in peel/pulp may be required."Significant residues" generally refer to residues above 0,1 mg/kg. If the pesticide concerned has a high acute toxicity and/or a low ADI, consideration must be given to conducting processing studies for determinable residues below 0,1 mg/kg.Studies on the effects on the nature of the residue are not normally required where only simple physical operations, not involving a change in temperature of the plant or the plant product, are involved such as washing, trimming or pressing.6.5.1. Effects on the nature of the residueAim of the testsThe objective of these studies is to establish whether or not breakdown or reaction products arise from residues in the raw products during processing which may require a separate risk assessment.Test conditionsDepending upon the level and chemical nature of the residue in the raw commodity, a set of representative hydrolysis situations (simulating the relevant processing operations) should be investigated, where appropriate. The effects of process other than hydrolysis, may also have to be investigated, where the properties of the active substance or metabolites indicate that toxicologically significant degradation products may occur as a result of these processes. The studies are normally conducted with a radio-labelled form of the active substance.6.5.2. Effects on the residue levelsAim of the testsThe main objectives of these studies are:- to determine the quantitative distribution of residues in the various intermediate and end products, and to estimate transfer factors,- to enable a more realistic estimate to be made of dietary intake of residues.Test conditionsProcessing studies should represent household processing and/or actual industrial processes.In the first instance it is usually only necessary to carry out a core set of "balance studies" representative of the common processes relevant to the plants or plant products containing significant residues. Justification should be given for the selection made of these representative process(es). The technology to be used in processing studies should always correspond as closely as possible to the actual conditions that are normally used in practice. A balance sheet should be made in which the mass balance of residues in all intermediate and end products is investigated. In drawing up such a balance sheet any concentrations or reductions in residues in individual products can be recognized and the corresponding transfer factors can also be determined.If the processed plant products play an important part in the diet, and if the "balance study" indicates that a significant transfer of residue into the processed products could occur, then three "follow-up studies" to determine residue concentration or dilution factors must be carried out.6.6. Residues in succeeding cropsAim of the testThe objective of these studies is to permit an evaluation of possible residues in succeeding crops.Circumstances in which requiredWhere data generated in accordance with Annex II, Section 7, point 7.1 or Annex III, Section 9, point 9.1, shows that significant residues (> 10 % of the applied active substance as a total of unchanged active substance and its relevant metabolites or degradation products) remain in soil or in plant materials, such as straw or organic material up to sowing or planting time of possible succeeding crops, and which could lead to residues above the limit of determination in succeeding crops at harvest, consideration should be given to the residue situation. This should include consideration of the nature of the residue in the succeeding crops and involve at least a theoretical estimation of the level of these residues. If the likelihood of residues in succeeding crops can not be excluded, metabolism and distribution studies should be carried out, if necessary followed by field trials.Test conditionsIf a theoretical estimation of residues in succeeding crops is done, full details and a justification shall be be given.Metabolism and distribution studies and field trials, if necessary, shall be carried out on representative crops chosen to represent normal agricultural practice.6.7. Proposed maximum residue levels (MRLs) and residue definitionA full justification for the proposed MRLs must be provided, including, where relevant, full details of the statistical analysis used.When judging which compounds are to be included in the residue definition, account has to be taken of the toxicological significance of the compounds, amounts likely to be present and the practicality of the analytical methods proposed for post-registration control and monitoring purposes.6.8. Proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest usesA full justification for the proposals must be provided.6.9. Estimation of the potential and actual exposure through diet and other meansConsideration will be given to the calculation of a realistic prediction of dietary intake. This may be done in a step-wise fashion leading to an increasingly realistic predictions of intake. Where relevant, other sources of exposure such as residues arising from the use of medicines or veterinary drugs have to be taken into account.6.10. Summary and evaluation of residue behaviourA summary and evaluation of all data presented in this Section 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 man and animals that may or do arise, and the extent, quality and reliability of the data base.In particular, the toxicological significance of any non-mammalian metabolites must be addressed.A schematic diagram should be prepared of the metabolic pathway in plants and animals with a brief explanation of the distribution and chemical changes involved.`ANNEX II Section 8 of Part A of Annex III to Directive 91/414/EEC is replaced by the following:'8. RESIDUES IN OR ON TREATED PRODUCTS, FOOD AND FEEDIntroductionThe provisions of Annex II, Section 6, Introduction apply.8.1. Metabolism, distribution and expression of residue in plants or livestockAim of the testsThe objectives of these studies are:- to provide an estimate of total terminal residues in the relevant portion of crops at harvest following treatment as proposed,- to quantify the rate of degradation and excretion of the total residue in certain animal products (milk or eggs) and excreta,- to identify the major components of the total terminal residue in crops and in edible animal products respectively,- to indicate the distribution of residues between relevant crop parts and between relevant edible animal products respectively,- to quantify the major components of the residue and to show the efficiency of extraction procedures for these components,- to generate data from which a decision on the need for livestock feeding studies as provided for in point 8.3 can be made,- to decide on the definition and expression of a residue.Circumstances in which requiredSupplementary metabolism studies only need to be performed where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of Annex II, Section 6, points 6.1 and 6.2. This might be the case for crops or for livestock for which data were not submitted in the framework of inclusion of the active substance in Annex I or were not necessary for amending the conditions of its inclusion in Annex I or where it could be expected that a different metabolism will occur.Test conditionsThe same provisions as provided under the corresponding paragraphs of Annex II, Section 6, points 6.1 and 6.2 apply.8.2. Residue trialsAim of the testsThe objectives of these studies are:- to quantify the highest likely residue levels in treated crops at harvest or outloading from store following the proposed good agricultural practice (GAP),and- to determine, when appropriate, the rate of decline of pesticide deposits.Circumstances in which requiredSupplementary residue trials only need to be performed where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of Annex II, Section 6, point 6.3. This might be the case for special formulations, for special application methods or for crops for which data were not submitted in the framework of inclusion of the active substance in Annex I or were not necessary for amending the conditions of its inclusion in Annex I.Test conditionsThe same provisions as provided under the corresponding paragraphs of Annex II, Section 6, point 6.3 apply.8.3. Livestock feeding studiesAim of the testsThe objective of these studies is to determine the residue in products of animal origin which will result from residues in feedingstuffs or fodder crops.Circumstances in which requiredSupplementary feeding studies for the purpose of assessing maximum residue levels for products of animal origin are only required where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of Annex II, Section 6, point 6.4. This might be the case where additional fodder crops are to be authorized which leads to an increased intake of residues of livestock for which data were not submitted in the framework of inclusion of the active substance in Annex I or were not necessary for amending the conditions of its inclusion in Annex I.Test conditionsThe same provisions as provided under the corresponding paragraphs of Annex II, Section 6, point 6.4 apply.8.4. Effects of industrial processing and/or household preparationsAim of the testsThe main objectives of these studies are:- to establish whether or not breakdown or reaction products arise from residues in the raw products during processing which may require a separate risk assessment,- to determine the quantitative distribution of residues in the various intermediate and end products, and to estimate transfer factors,- to enable a more realistic estimate to be made of dietary intake of residues.Circumstances in which requiredSupplementary studies only need to be performed where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of Annex II, Section 6, point 6.5. This might be the case for crops for which data were not submitted in the framework of inclusion of the active substance in Annex I or were not necessary for amending the conditions of its inclusion in Annex I.Test conditionsThe same provisions as provided under the corresponding paragraphs of Annex II, Section 6, point 6.5 apply.8.5. Residues in succeeding cropsAim of the testThe objective of these studies is to permit an evaluation of possible residues in succeeding crops.Circumstances in which requiredSupplementary studies are only required where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of Annex II, Section 6, point 6.6. This might be the case for special formulations, for special application methods or for crops for which data were not submitted in the framework of inclusion of the active substance in Annex I or were not necessary for amending the conditions of its inclusion in Annex I.Test conditionsThe same provisions as provided under the corresponding paragraphs of Annex II, Section 6, point 6.6 apply.8.6. Proposed maximum residue levels (MRLs) and residue definitionA full justification for the proposed MRLs must be provided, including, where relevant, full details of the statistical analysis used.If the metabolism studies submitted in accordance with the provisions of point 8.1 indicate that the residue definition should be changed taking into account the actual residue definition and the necessary judgement as outlined under the corresponding paragraph of Annex II, Section 6, point 6.7, a re-evaluation of the active substance may be necessary.8.7. Proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest usesA full justification for the proposals must be provided.8.8. Estimation of the potential and actual exposure through diet and other meansConsideration will be given to the calculation of a realistic prediction of dietary intake. This may be done in a step-wise fashion leading to an increasingly realistic prediction of intake. Where relevant, other sources of exposure such as residues arising from the use of medicines or veterinary drugs have to be taken into account.8.9. Summary and evaluation of residue behaviourA summary and evaluation of all data presented in this Section 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 man and animals that may or do arise, and the extent, quality and reliability of the data base.Where metabolism data have been submitted the toxicological significance of any non-mammalian metabolites must be addressed.A schematic diagram should be prepared of the metabolic pathway in plants and animals with a brief explanation of the distribution and chemical changes involved if metabolism data have been submitted.`


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32001L0028

Commission Directive 2001/28/EC of 20 April 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include KBR 2738 (fenhexamid) as an active substance

Official Journal L 113 , 24/04/2001 P. 0005 - 0007

Commission Directive 2001/28/ECof 20 April 2001amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include KBR 2738 (fenhexamid) as an active substanceTHE 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 2001/21/EC(2), and in particular Article 6(1) thereof,Whereas:(1) In accordance with Article 6(2) of Directive 91/414/EEC (hereinafter referred to as "the Directive") the United Kingdom received on 8 May 1997 an application from Bayer plc ("the applicant") for the inclusion of the active substance KBR 2738 (fenhexamid) in Annex I to the Directive.(2) In accordance with the provisions of Article 6(3) of the Directive the Commission confirmed in its Decision 98/398/EC(3) that the dossier submitted for KBR 2738 (fenhexamid) could be considered as satisfying, in principle, the data and information requirements of Annex II and for a plant protection product containing this active substance, of Annex III to the Directive.(3) In accordance with Article 5(1) of the Directive, an active substance should be included in Annex I for a period not exceeding 10 years if it may be expected that neither the use of, or residues from, plant protection products containing the active substance will have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment.(4) For KBR 2738 (fenhexamid), the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of the Directive, for the uses proposed by the applicant. The United Kingdom acting as nominated rapporteur Member State, submitted a draft assessment report concerning the substance to the Commission on 15 October 1998.(5) That assessment report has been reviewed by the Member States and the Commission within the Standing Committee on Plant Health. The review was finalised on 19 October 2000 in the format of the Commission review report for KBR 2738 (fenhexamid). If the review report has to be updated to take account of technical and scientific developments, the conditions for the inclusion of KBR 2738 (fenhexamid) in Annex I to the Directive will also need to be amended in accordance with the Directive.(6) The dossier and the information from the review were submitted to the Scientific Committee on Plants for opinion on 31 March 2000. This Committee has given its opinion on 20 July 2000 in the minutes of the meeting (SCP/REPT/021 final)(4) where it was stated that the Committee did not wish to raise any issues with regard to this active substance. The Committee also noted that national authorisations would involve specific risk management in line with Annex VI(5) (Uniform principles) of the Directive.(7) It has appeared from the various examinations made that plant protection products containing the active substance concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a), (b) and (3) of the Directive, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include the active substance concerned in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing the active substance concerned can be granted in accordance with the provisions of the said Directive.(8) After inclusion, a reasonable period is necessary to permit Member States to implement the provisions of the Directive on plant protection products containing KBR 2738 (fenhexamid) and in particular to review, within this period, existing provisional authorisations or to grant, by the end of this period at the latest, new authorisations in accordance with the provisions of the Directive. A longer period may also be required for plant protection products containing KBR 2738 (fenhexamid) and other active substances included in Annex I.(9) It is appropriate to provide that the finalised review report (except for confidential information in the meaning of Article 14 of the Directive) is kept available or made available by the Member States for consultation by any interested parties.(10) The review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Annex VI to the Directive, where those principles refer to the evaluation of the data which were submitted for the purpose of the inclusion of the active substance in Annex I to the Directive.(11) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health delivered on 19 October 2000,HAS ADOPTED THIS DIRECTIVE:Article 1The table in Annex I to Directive 91/414/EEC shall be amended to include the entry in respect of KBR 2738 (fenhexamid) set out in the Annex hereto.Article 21. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive, at the latest by 1 August 2001. They shall forthwith inform the Commission thereof.When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.2. However, with regard to evaluation and decision-making pursuant to the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III thereto, the period laid down in the first paragraph is extended for existing provisional authorisations of plant protection products containing KBR 2738 (fenhexamid) to 1 August 2002.3. However for plant protection products containing KBR 2738 (fenhexamid) together with another active substance which is in Annex I to Directive 91/414/EEC, the period referred to in paragraph 1 is extended to the extent that a longer implementation period is provided for by the provisions laid down in the Directive amending Annex I to Directive 91/414/EEC to include the substance in the Annex.4. Member States shall keep available the review report for KBR 2738 (fenhexamid) (except for confidential information within the meaning of Article 14 of the Directive) for consultation by any interested parties or shall make it available to them on specific request.Article 3This Directive shall enter into force on 1 June 2001.Article 4This Directive is addressed to the Member States.Done at Brussels, 20 April 2001.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1.(2) OJ L 69, 10.3.2001, p. 17.(3) OJ L 176, 20.6.1998, p. 34.(4) Minutes of the 21st meeting of the Scientific Committee on Plants, Brussels, 20 July 2000.(5) OJ L 265, 27.9.1997, p. 87.ANNEXENTRY TO BE INSERTED IN THE TABLE IN ANNEX I TO DIRECTIVE 91/414/EEC">TABLE>"


Avis juridique important

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31991L0191

Council Directive 91/191/EEC of 27 March 1991 amending Directive 69/169/EEC on tax-paid allowances in intra- Community travel and as regards a derogation granted to the Kingdom of Denmark and to Ireland relating to the rules governing travellers' allowances on imports

Official Journal L 094 , 16/04/1991 P. 0024 - 0025 Finnish special edition: Chapter 9 Volume 2 P. 0029  Swedish special edition: Chapter 9 Volume 2 P. 0029

COUNCIL DIRECTIVE  of 27 March 1991  amending Directive 69/169/EEC on tax-paid allowances in intra-Community travel and as regards a derogation granted to the Kingdom of Denmark and to Ireland relating to the rules governing travellers' allowances  on imports  (91/191/EEC)THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 99 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Article 8a of the Treaty defines the internal market as an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured and states that this market should be progressively established over a  period expiring on 31 December 1992;  Whereas the system of travellers' allowances applies to goods which move about tax paid and in this respect anticipates the mode of movement of goods which will apply in the internal market;  Whereas, taking into account the progressive nature of the creation of the internal market as stated in Article 8a of the Treaty, an increase is necessary, as a first step, for the value allowance both for this market and for achieving the aim of  Council Directive 69/169/EEC of 28 May 1969 on the harmonization of provisions laid down by law, regulation or administrative action relating to exemption from turnover tax and excise duty on imports in international travel (4), as last amended by  Directive 89/194/EEC (5), as set out in the second recital thereto; whereas establishing the market means that goods bought tax paid will be able to be taken across internal frontiers without any liability to pay further tax and that the existing  allowances for travellers will cease to exist because they will have no meaning;  Whereas it is necessary in the same way to phase out all differences in the treatment of travellers entering various Member States;  Whereas it is necessary, for a limited period, to provide derogations for Ireland and the Kingdom of Denmark in view of the economic difficulties caused by the application of the general levels of allowances,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 69/169/EEC is hereby amended as follows:  1. In Article 2, as from 1 July 1991:  - in paragraph 1, 'ECU 390' is replaced by 'ECU 600',  - in paragraph 2, 'ECU 100' is replaced by 'ECU 150'.  2. In Article 5, the following paragraph is inserted and paragraphs 5, 6 and 7 are renumbered 6, 7 and 8:  '5. In the case of Ireland and the Kingdom of Denmark, in no case shall the restrictions in paragraph 1 be such that those to whom the restrictions apply are able to enjoy a more favourable treatment than that accorded by the limits set out in Articles  7c and 7d. The restrictions set out in paragraph 1 shall be calculated by reference to Articles 2 and 4 (1) column II of the table.'  3. In Article 7b, as from 1 July 1991:  (a) In paragraph 1:  - subparagraph (a) is replaced by the following:  '(a) the Kingdom of Denmark and the Hellenic Republic shall be authorized to exclude, from the exemption, goods the unit value of which exceeds ECU 340.'  - in subparagraph (b), 'ECU 85' is replaced by 'ECU 95'.  (b) In paragraph 2, 'ECU 85' is replaced by 'ECU 95'.  4. Article 7c shall be replaced by the following:  'Article 7c  Notwithstanding Articles 2 (1) and 4 (1), the Kingdom of Denmark shall be authorized to apply the following quantitative limits until 31 December 1991 for the importation of the goods in question by travellers resident in Denmark after a stay of less  than 36 hours outside Denmark:   Products      - Cigarettes  100  - Distilled beverages and spirits of an alcoholic strength by volume more than 22 % vol.  nil  - Beer  12 litres'    5. The following Article 7d is added:  'Article 7d  Notwithstanding Article 2 (1) and within the limit set out therein, Ireland shall be authorized to apply a quantitative limit of 25 litres of beer for all travellers to Ireland until 31 December 1991.  Notwithstanding Articles 2 (1) and 4 (1), Ireland shall be authorized to apply the following limits until 31 December 1991 for the importation of the goods in question by travellers from Ireland after a stay of less than 24 hours outside Ireland:  (a) for travellers from the Community, ECU 110,  (b)   Products      - Cigarettes or  150  - Smoking tobacco  200 g  - Distilled beverages and spirits of an alcoholic strength by volume of more than 22 %; or  3/4 litre  or   - Distilled beverages and spirits, and aperitifs with a wine or alcohol base,  sake or similar beverages of an alcoholic strength by volume of 22 % or less; sparking wines, fortified wines and  1,5 litres  - Still wines (*),  2,5 litres  - Beer  12 litres    (*) For travellers from third countries, the limit for still wines  provided for in Article 4(1) shall apply.' Article 2  1. Member States shall bring into force the measures necessary to comply with this Directive:  - as regards Article 1, points 1, 2 and 3, with effect from 1 July 1991,  - as regards Article 1, points 4 and 5, on the day of notification (6) of this Directive to the Member States.  2. When the 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.  3. Member States shall inform the Commission of the main provisions of domestic law which they adopt in order to comply with this Directive.  Article 3  This Directive is addressed to the Member States. Done at Brussels, 27 March 1991. For the Council  The President  R. GOEBBELS  (1) OJ No C 245, 26. 9. 1989, p. 5 and OJ No C 70, 20. 3. 1990, p. 6. (2) OJ No C 323, 27. 12. 1989, p. 119. (3) OJ No C 329, 30. 12. 1989, p. 59. (4) OJ No L 133, 4. 6. 1969, p. 6. (5) OJ No L 73, 17. 3. 1989, p. 47. (6) This Directive was  notified to the Member States on 8 April 1991.


title: Commission Directive 2010/38/EU of 18 June 2010 amending Council Directive 91/414/EEC to include sulfuryl fluoride as active substance  (Text with EEA relevance )

text:
               19.6.2010

               EN

               Official Journal of the European Union

               L 154/21

         COMMISSION DIRECTIVE 2010/38/EU
   of 18 June 2010
   amending Council Directive 91/414/EEC to include sulfuryl fluoride as active substance
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 29 July 2002 an application from Dow AgroScience for the inclusion of the active substance sulfuryl fluoride in Annex I to Directive 91/414/EEC. Commission Decision 2004/131/EC (2) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

               (2)

               For that active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The rapporteur Member State submitted a draft assessment report on 29 October 2004.

               (3)

               The assessment report was peer reviewed by the Member States and the European Food Safety Authority (EFSA) and presented to the Commission on 17 December 2009 (3). The draft review report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and was finalised on 12 March 2010 in the format of the Commission review report for sulfuryl fluoride.

               (4)

               It has appeared from the various examinations made that plant protection products containing sulfuryl fluoride may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include sulfuryl fluoride in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.

               (5)

               Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that the inclusion of a substance in Annex I may be subject to conditions. It is appropriate, as regards sulfuryl fluoride, to require that the notifier submit further information on milling processing conditions necessary to ensure that residues of fluoride ion in cereals do not exceed the natural background levels, on tropospheric concentrations of sulfuryl fluoride and on estimates of sulfuryl fluoride atmospheric lifetime.

               (6)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing provisional authorisations of plant protection products containing sulfuryl fluoride to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (7)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (8)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 28 February 2011 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 March 2011.
   When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing sulfuryl fluoride as active substance by 28 February 2011. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to sulfuryl fluoride are met, with the exception of those identified in part B of the entry concerning the active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13(2) of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing sulfuryl fluoride as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 August 2010 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning sulfuryl fluoride. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing sulfuryl fluoride as the only active substance, where necessary, amend or withdraw the authorisation by 29 February 2012 at the latest; or

               (b)

               in the case of a product containing sulfuryl fluoride as one of several active substances, where necessary, amend or withdraw the authorisation by 29 February 2012 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 4
   This Directive shall enter into force on 1 September 2010.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 18 June 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 37, 10.2.2004, p. 34.

      (3)  The EFSA Journal 2010; 8(1):1441. [66 pp.], Conclusion on the peer review of the pesticide risk assessment of the active substance sulfuryl fluoride (finalised: 17 December 2009).

      ANNEX
      In Annex I to Directive 91/414/EEC, the following entry is added at the end of the table:

                  No

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Entry into force

                  Expiration of inclusion

                  Specific provisions

                  ‘311

                  Sulfuryl fluoride
                  CAS No 002699-79-8
                  CIPAC No 757

                     Sulfuryl fluoride

                  > 994 g/kg

                  1 November 2010

                  31 October 2020

                  PART A
                  Only uses as insecticide/nematicide (fumigant) applied by professional users in sealable structures

                              (a)

                              which are empty; or

                              (b)

                              where conditions of use ensure that consumer exposure is acceptable;

                        may be authorised.
                  PART B
                  For the implementation of the uniform principles of Annex VI, the conclusions of the review report on sulfuryl fluoride, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.
                  In this overall assessment, Member States must pay particular attention to:

                              —

                              the risk posed by inorganic fluoride through contaminated products, such as flour and bran that remained in the mill machinery during fumigation, or grain stored in silos in the mill. Measures are required to ensure that such products do not enter the food and feed chain,

                              —

                              the risk to operators and the risk to workers, such as when re-entering a fumigated structure after aeration. Measures are required to ensure that they wear self containing breathing apparatus or other appropriate personal protective equipment,

                              —

                              the risk to bystanders by applying an appropriate exclusion zone around the fumigated structure.

                        Conditions of authorisation shall include risk mitigation measures, where appropriate.
                  The Member States concerned shall ensure that the notifier submits to the Commission further information and in particular, confirmatory data on:

                              —

                              the mill processing conditions necessary to ensure that residues of fluoride ion in flour, bran and grain do not exceed the natural background levels,

                              —

                              tropospheric concentrations of sulfuryl fluoride. Measured concentrations should be updated regularly. The limit of detection for the analysis shall be at least 0,5 ppt (equivalent to 2,1 ng sulfuryl fluoride/m3 of tropospheric air),

                              —

                              estimates of sulfuryl fluoride atmospheric lifetime based on worst case scenario, with respect to the global warming potential (GWP).

                        They shall ensure that the notifier provides such information to the Commission by 31 August 2012.’

         (1)  Further details on identity and specification of active substances are provided in the review report.


title: Commission Directive 2010/56/EU of 20 August 2010 amending Annex I to Council Directive 91/414/EEC to renew the inclusion of prohexadione as active substance  Text with EEA relevance

text:
               21.8.2010

               EN

               Official Journal of the European Union

               L 220/71

         COMMISSION DIRECTIVE 2010/56/EU
   of 20 August 2010
   amending Annex I to Council Directive 91/414/EEC to renew the inclusion of prohexadione as active substance
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               The inclusion of prohexadione (formerly prohexadione-calcium) in Annex I to Directive 91/414/EEC expires on 31 December 2011. A notification was submitted in accordance with Article 4 of Commission Regulation (EC) No 737/2007 of 27 June 2007 on laying down the procedure of the renewal of the inclusion of a first group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances (2) for the renewal of the inclusion of prohexadione to as active substance in Annex I to Directive 91/414/EEC within the time period provided for in that Article.

               (2)

               That notification was found to be admissible by Commission Decision 2008/656/EC of 28 July 2008 on the admissibility of the notifications concerning the renewal of the inclusion in Annex I to Council Directive 91/414/EEC of the active substances azimsulfuron, azoxystrobin, fluroxypyr, imazalil, kresoxim-methyl, prohexadion-calcium and spiroxamin, and establishing the list of the notifiers concerned (3).

               (3)

               Within the time period provided for in Article 6 of Regulation (EC) No 737/2007, the notifier submitted the data required in accordance with Article 6 of Regulation (EC) No 737/2007 together with an explanation as regards the relevance of each new study submitted.

               (4)

               The rapporteur Member State prepared an assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter: ‘the Authority’) and the Commission on 22 May 2009. In addition to the assessment of the substance, that report includes a list of the studies the rapporteur Member State relied on for its assessment.

               (5)

               The Authority communicated the assessment report to the notifier and to all the Member States and forwarded the comments received to the Commission. The Authority also made the assessment report available to the public.

               (6)

               At the request of the Commission, the assessment report was peer reviewed by the Member States and the Authority, the Authority presented its conclusion on the peer review of the risk assessment of prohexadione (considered variant prohexadione-calcium) (4) to the Commission on 6 April 2010. The assessment report and the conclusion from the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 9 July 2010 in the format of the Commission review report for prohexadione.

               (7)

               It has appeared from the various examinations made that plant protection products containing prohexadione may be expected to continue to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular as regards the uses which were examined and detailed in the Commission review report. It is therefore appropriate to renew the inclusion of prohexadione in Annex I to Directive 91/414/EEC, in order to ensure that plant protection products containing this active substance may continue to be authorised where they comply with that Directive.

               (8)

               A reasonable period should be allowed to elapse before the inclusion of an active substance in Annex I to Directive 91/414/EEC is renewed in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the renewal.

               (9)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of renewing the inclusion of an active substance in Annex I thereof, Member States should be allowed a period of six months after renewal to review authorisations of plant protection products containing prohexadione to make sure that the requirements laid down in Directive 91/414/EEC, in particular in its Article 13, and the relevant conditions set out in Annex I to that Directive, continue to be satisfied. As appropriate, Member States should renew, where appropriate with modifications, or refuse to renew authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the update of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (10)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (11)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended in accordance with the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 31 January 2012 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 February 2012.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing prohexadione as an active substance by 31 January 2012.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to prohexadione are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing prohexadione as either the only active substance or as one of several active substances, all of which were listed in Annex I to Directive 91/414/EEC by 31 July 2011 at the latest, Member States shall, where necessary, re-evaluate the products, to take into account developments occurred in the scientific and technical knowledge and in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning prohexadione. On the basis of that evaluation, they shall determine whether the product still satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall, where necessary, amend or withdraw the authorisation by 31 July 2015.
   3.   By way of derogation from paragraphs 1 and 2, for each authorised plant protection product containing prohexadione as one of several active substances, all of which were listed in Annex I to Directive 91/414/EEC by 31 July 2011 at the latest, and at least one of which was included in Annex I to Directive 91/414/EEC between 1 January 2009 and 31 July 2011, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning prohexadione. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall, where necessary, amend or withdraw the authorisation by 31 July 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.
   Article 4
   This Directive shall enter into force on 1 August 2011.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 20 August 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 169, 29.6.2007, p. 10.

      (3)  OJ L 214, 9.8.2008, p. 70.

      (4)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance prohexadione – on request from the European Commission EFSA Journal 2010; 8(3):1555.

      ANNEX
      In Annex I to Directive 91/414/EEC, row No 8 is replaced by the following:

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘8

                     prohexadione

                        CAS No: 127277-53-6 (prohexadione-calcium)

                        CIPAC No: 567 (prohexadione)

                        No: 567.020 (prohexadione-calcium)

                     3,5-dioxo-4-propionylcyclohexanecarboxylic acid

                     ≥ 890 g/kg
                     (expressed as prohexadione-calcium)

                     1 August 2011

                     31 July 2021

                     PART A
                     Only uses as plant growth regulator may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on prohexadione and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 July 2010 shall be taken into account.’

         (1)  Further details on identity and specification of active substance are provided in the review report.


Avis juridique important

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31997L0073

Commission Directive 97/73/EC of 15 December 1997 including an active substance (imazalil) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)

Official Journal L 353 , 24/12/1997 P. 0026 - 0028

COMMISSION DIRECTIVE 97/73/EC of 15 December 1997 including an active substance (imazalil) in Annex I to 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 Directive 97/57/EC (2), and in particular Article 6 (1) and the fourth subparagraph of Article 8 (2) thereof,Whereas Commission Regulation (EEC) No 3600/92 (3), as last amended by Regulation (EC) No 1199/97 (4), has laid down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8 (2) of Directive 91/414/EEC (hereinafter referred to as 'the Directive`); whereas, pursuant to that Regulation, Commission Regulation (EC) No 933/94 (5), as last amended by Regulation (EC) No 2230/95 (6), laid down the list of active substances of plant protection products to be assessed, with a view to their possible inclusion in Annex I to the Directive;Whereas those active substances should be included in that Annex when it may be expected that there will not be any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment;Whereas such inclusion should be made for a period not exceeding 10 years;Whereas the Directive, at Article 8 (2), provides that after inclusion of an active substance in Annex I to the Directive, Member States shall, within a prescribed period, grant, vary or withdraw, as appropriate, the authorizations of the plant protection products containing the active substance; whereas, in particular, Articles 4 (1) and 13 (1) of the Directive require that plant protection products are not authorized unless account is taken of the conditions associated with the inclusion of the active substance in Annex I and the uniform principles laid down in Annex VI on the basis of a dossier satisfying the data requirements laid down in Article 13;Whereas for imazalil the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92, for a number of uses proposed by the notifiers; whereas Belgium, acting on behalf of Luxembourg as designated rapporteur Member State pursuant to Regulation (EC) No 933/94, has submitted to the Commission on 15 July 1996 the relevant assessment report;Whereas the submitted report has been reviewed by the Member States and the Commission within the Standing Committee on Plant Health; whereas this review has been finalized on 11 July 1997 in the format of the Commission review report for imazalil, in accordance with the provisions of Article 7 (6) of Regulation (EEC) No 3600/92; whereas it may be necessary to update this report from time to time to take into account technical and scientific developments; whereas in such case the conditions for the inclusion of imazalil in Annex I to Directive 91/414/EEC will also need to be amended pursuant to Article 6 (1) of that Directive;Whereas it has appeared from the assessments made that plant protection products containing the active substance concerned may be expected to satisfy in general the requirements laid down in Article 5 (1) (a) and (b) of the Directive, in particular with regard to the uses which were examined; whereas therefore it is necessary to include the active substance concerned in Annex I, in order to ensure that, in all Member States, the granting, varying or withdrawing, as appropriate, of the authorizations of plant protection products containing the active substance concerned can be organized in accordance with the provisions of the Directive, and to ensure that this activity is not further delayed;Whereas before inclusion a reasonable deadline is necessary to permit Member States and the interested parties to prepare themselves to the new requirements which will result from the inclusion; whereas moreover after inclusion a reasonable period is necessary for the Member States to implement the Directive and in particular to vary or withdraw, as appropriate, existing authorizations or grant new authorizations in accordance with the provisions of Directive 91/414/EEC; whereas a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product in accordance with the uniform principles laid down in Annex VI to the Directive; whereas, however, for plant protection products containing several active substances, the complete evaluation on the basis of the uniform principles can only be carried out when all the active substances concerned have been included in Annex I to the Directive;Whereas the periods laid down for implementation of this Directive do not prejudice the periods which will be established for the inclusion of other active substances in Annex I to the Directive;Whereas the review report is required for the proper implementation by the Member States of several sections of the uniform principles laid down in Annex VI to the Directive, where these principles refer to the evaluation of the Annex II data which were submitted for the purpose of the inclusion of the active substance in Annex I to the Directive;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 Imazalil is hereby designated as an active substance in Annex I to Directive 91/414/EEC, as set out in the Annex hereto.Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive, not later than 30 June 1999 (7); in particular they shall, in accordance with the provisions of Directive 91/414/EEC, where necessary, vary or withdraw existing authorizations for plant protection products containing imazalil as active substance within such period.However, with regard to evaluation and decision-making pursuant to the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III thereto, the period laid down in the first subparagraph is extended:- for plant protection products containing only imazalil, and not intended for outdoor foliar uses, to four years from the entry into force of this Directive,- for plant protection products containing imazalil and other active substances not yet included in Annex I, and not intended for outdoor foliar uses, to four years from the entry into force of such Directive as shall include the last of those substances in Annex I.2. When Member States adopt the provisions referred to in paragraph 1, 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 Member States.Article 3 This Directive shall enter into force on 1 January 1999 (8).Article 4 This Directive is addressed to the Member States.Done at Brussels, 15 December 1997.For the CommissionFranz FISCHLERMember of the Commission(1) OJ L 230, 19. 8. 1991, p. 1.(2) OJ L 265, 27. 9. 1997, p. 87.(3) OJ L 366, 15. 12. 1992, p. 10.(4) OJ L 170, 28. 6. 1997, p. 19.(5) OJ L 107, 28. 4. 1994, p. 8.(6) OJ L 225, 22. 9. 1995, p. 1.(7) In principle six months from the date of entry into force of the present Directive.(8) In principle 12 months from the date of adoption of the present Directive.ANNEX IMAZALIL1. Identity:(Iupac name) (±) -1-(â-allyloxy-2,4-dichlorophenylethyl) imidazoleor(±) -allyl 1-(2,4-dichlorophenyl)-2-imidazol-1-ylethyl ether2. Particular conditions to be fulfilled:2.1. Purity of the active substance as manufactured shall satisfy the specification established by FAO for this active substance.2.2. Only uses as fungicide may be authorized.2.3. For the following uses the following particular conditions apply:- post harvest fruit, vegetable and potato treatments may only be authorized when an appropriate decontamination system is available or a risk assessment has demonstrated to the authorizing Member State that the discharge of the treatment solution does not have an unacceptable risk to the environment and in particular to aquatic organisms,- post harvest treatment of potatoes may only be authorized when a risk assessment has demonstrated to the authorizing Member State that the discharge of the processing waste from treated potatoes does not have an unacceptable risk to aquatic organisms,- outdoor foliar uses may only be authorized when a risk assessment has demonstrated to the authorizing Member State that the use has no unacceptable effects on human and animal health and the environment.2.4. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on imazalil, and in particular Appendixes I and II thereof, as finalized in the Standing Committee on Plant Health on 11 July 1997 shall be taken into account.3. Expiry date of the inclusion: 31 December 2008.