Avis juridique important

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31990L0506

Ninth Commission Directive 90/506/EEC of 26 September 1990 amending annex IV to Council Directive 77/93/CEE on protective measures against the introduction into the member states of organisms harmful to plants or plant products

Official Journal L 282 , 13/10/1990 P. 0067 - 0068 Finnish special edition: Chapter 3 Volume 34 P. 0186  Swedish special edition: Chapter 3 Volume 34 P. 0186

*****NINTH  COMMISSION DIRECTIVE  of 26 September 1990  amending Annex IV to Council Directive 77/93/CEE on protective measures against the introduction into the Member States of organisms harmful to plants or plant products  (90/506/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 Commission Directive 90/490/EEC (2), and in particular Article 13, second paragraph, fourth indent thereof,  Whereas the provisions on protective measures against harmful organisms such as Amauromyza and Liriomyza should be improved, and in particular adapted to the present distribution of such organisms;  Whereas therefore the relevant Annex of Directive 77/93/EEC should be amended accordingly;  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 IV, part A to Directive 77/93/EEC, points 33 a and 33 b are replaced by the following:  1.2 //  //  // '33 a. Plants of Apium graveolens, Brassica, Capsicum annuum, Chrysanthemum, Cucumis, Dendranthema, Dianthus, Gerbera, Gypsophila, Lactuca sativa, Leucanthemum, Lycopersicon esculentum, Solanum melongena, Tanacetum, intended for planting, other than seeds, originating in a Member State or in those third countries where it has been ascertained, in accordance with the procedure laid down in Article 16, that: - amauromyza maculosa, - Liriomyza huidobrensis, - Liriomyza sativae, - Liriomyza trifolii are not known to occur.  // Official statement that: - either no signs of any of the relevant harmful organisms have been observed at the place of production on official inspections carried out at least monthly during the three months prior to harvesting, or - immediately prior to export the plants have been inspected and found free from signs of the relevant harmful organisms and have been subjected to an appropriate treatment aimed at eradicating the relevant harmful organisms.   // 33 b. Plants of species covered by 33 a for planting, other than seeds, originating in American countries or in any other third country not covered by 33 a.  // Official statement that no signs of Amauromyza maculosa, Liriomyza huidobrensis, Liriomyza sativae or Liriomyza trifolii have been observed at the place of production, on official inspections carried out at least 1990, p. 28.   // 33 c. Plants of herbaceous species, other than those covered by 33 a, for planting, other than seeds, originating in a Member State where any of the harmful organisms specified in 33 a are known to occur or in American countries or in any other third country not covered by 33 a.  // Official statement that: - either no signs of any of the relevant harmful organisms have been observed at the place of production on an official inspection carried out prior to harvesting, or - immediately prior to export the plants have been inspected and found free from signs of the relevant harmful organisms and have been subjected to an appropriate treatment aimed at eradicating the relevant harmful organisms.'  Article 2  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1991.  These provisions shall make express reference to 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 is addressed to the Member States.  Done at Brussels, 26 September 1990.  For the Commission  Ray MAC SHARRY  Member of the Commission monthly during the three months prior to harvesting.  (1) OJ No L 26, 31. 1. 1977, p. 20. (2) OJ No L 271, 3. 10.


Avis juridique important

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32001L0087

Commission Directive 2001/87/EC of 12 October 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine and pyraflufen-ethyl as active substances

Official Journal L 276 , 19/10/2001 P. 0017 - 0020

Commission Directive 2001/87/ECof 12 October 2001amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine and pyraflufen-ethyl as active substancesTHE 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 2001/49/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") France received on 15 October 1996 an application from Novartis (now Syngenta) for the inclusion of the active substance acibenzolar-s-methyl (CGA 245704) in Annex I to the Directive. By Commission Decision 97/865/EC(3) it was confirmed that the dossier was "complete" i.e. it could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to the Directive.(2) Greece received a similar application on 27 March 1996 from Rhône Poulenc Agrochimie SA (now Aventis CropScience), concerning cyclanilide (RPA 090946). This application was declared complete by Commission Decision 97/137/EC(4).(3) On 27 August 1998, Germany received an application from W. Neudorff GmbH KG, concerning ferric phosphate. This application was declared complete by Commission Decision 1999/43/EC(5).(4) Germany also received on 4 September 1996 an application from Novartis concerning pymetrozine (CGA 215944). By Commission Decision 97/865/EC this application was declared complete.(5) On 16 June 1997, Belgium received an application from Nihon Nohyaku Co. Ltd, concerning pyraflufen-ethyl. This application was declared complete by Commission Decision 98/242/EC(6).(6) For these five active substances, 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 respective applicant. The nominated rapporteur Member States, submitted draft assessment reports concerning the substances to the Commission on 17 December 1998 (acibenzolar-s-methyl), 11 February 1998 (cyclanilide), 30 July 1999 (ferric phosphate), 28 May 1998 (pymethrozine) and 8 July 1999 (pyraflufen-ethyl), respectively.(7) The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on Plant Health. The reviews were finalised on 29 June 2001 in the format of the individual Commission review reports for acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymethrozine and pyraflufen-ethyl.(8) The dossier and the information from each of the reviews were submitted to the Scientific Committee for Plants. As regards acibenzolar-s-methyl and ferric phosphate, no specific questions were addressed to the Committee. The Committee considered that there were no issues that it wished to raise regarding the active substances in the context of a possible inclusion in Annex I to the Directive(7). The Committee noted that absence of comment should only be interpreted as an indication of no obvious reasons necessitating comment.(9) In its opinion(8) concerning cyclanilide the Committee provided its interpretation of certain effects observed in mice and rabbits and recommended a reassessment of the degradation of the soil metabolite 2,4-dichloraniline. The recommendations of the Committee have been taken into consideration.(10) In its opinion(9) on pymetrozine the Committee assessed certain effects in the context of deriving an acceptable daily intake and an acute reference dose for consumers.(11) In its opinion(10) on pyraflufen-ethyl the Committee concluded that there is generally negligible risk of groundwater contamination for the parent compound and its breakdown products. However, under extreme conditions the fate of certain breakdown products should be assessed carefully.(12) It has appeared from the various examinations made that plant protection products containing any of the active substances 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 respective Commission review reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing the active substances concerned can be granted in accordance with the provisions of the said Directive.(13) After inclusion, a reasonable period is necessary to permit Member States to implement the provisions of the Directive on plant protection products containing acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine or pyraflufen-ethyl 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 any of the active substances concerned and other active substances included in Annex I.(14) 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. It is, therefore, appropriate to provide that the finalised review reports (except for confidential information in the meaning of Article 14 of the Directive) are kept available or made available by the Member States for consultation by any interested parties. If a review report has to be updated to take account of technical and scientific developments, the conditions for the inclusion of the active substance concerned in Annex I to the Directive should also be amended in accordance with the Directive.(15) 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 1The table in Annex I to Directive 91/414/EEC shall be amended as 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 31 March 2002. 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 acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine or pyraflufen-ethyl to 31 March 2003.3. However for plant protection products containing acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine or pyraflufen-ethyl 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 reports for acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine and pyraflufen-ethyl (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 November 2001.Article 4This Directive is addressed to the Member States.Done at Brussels, 12 October 2001.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1.(2) OJ L 176, 29.6.2001, p. 61.(3) OJ L 351, 23.12.1997, p. 67.(4) OJ L 52, 22.2.1997, p. 20.(5) OJ L 14, 19.1.1999, p. 30.(6) OJ L 96, 28.3.1998, p. 45.(7) Minutes of the plenary meeting of the Scientific Committee for Plants from 7 March 2001 (acibenzolar-s-methyl).Minutes of the plenary meeting of the Scientific Committee for Plants from 4 June 2001 (ferric phosphate).(8) Opinion of the Scientific Committee for Plants regarding the evaluation of cyclanilide in the context of Directive 91/414/EEC concerning the placing of plant protection products on the market. SCP/CYCLAN/002-final dated 11 December 2000.(9) Opinion of the Scientific Committee for Plants regarding the evaluation of pymetrozine in the context of Directive 91/414/EEC concerning the placing of plant protection products on the market. SCP/PYMETR/002-final dated 31 January 2001.(10) Opinion of the Scientific Committee for Plants regarding the evaluation of pyraflufen-ethyl in the context of Directive 91/414/EEC concerning the placing of plant protection products on the market. SCP/PYRA/-final dated 7 March 2001.ANNEXENTRIES TO BE INSERTED IN THE TABLE IN ANNEX I TO DIRECTIVE 91/414/EEC">TABLE>"


Avis juridique important

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32003L0112

Commission Directive 2003/112/EC of 1 December 2003 amending Council Directive 91/414/EEC to include paraquat as an active substance (Text with EEA relevance)

Official Journal L 321 , 06/12/2003 P. 0032 - 0035

Commission Directive 2003/112/ECof 1 December 2003amending Council Directive 91/414/EEC to include paraquat as an active substance(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 2003/84/EC(2), and in particular Article 6(1) thereof,Whereas:(1) Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market(3), as last amended by Regulation (EC) No 2266/2000(4), establishes a list of active substances of plant protection products to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes paraquat.(2) For paraquat, 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 range of uses proposed by the notifier. Pursuant to Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member State for the implementation of Commission Regulation (EEC) No 3600/92(5), as last amended by Regulation (EC) No 2230/95(6), the United Kingdom was designated as rapporteur Member State. The United Kingdom submitted the relevant assessment reports and recommendations to the Commission on 31 October 1996 in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92.(3) This assessment report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 3 October 2003 in the format of the Commission review report for paraquat.(4) The report on paraquat and further information were also submitted to the Scientific Committee for Plants. The Committee was asked to comment on the relevance for consumers and operators of the ocular and pulmonary changes, which were observed in the long-term rat study, on the risk for operators, taking into particular account potential inhalatory and dermal exposure, on potential long-term effects to soil-dwelling organisms, and on the risks the intended uses might pose to reproducing birds and hares. In its opinion(7), the Scientific Committee concluded that neither the pulmonary lesions observed in animals after oral administration of paraquat nor the systemic effects on the eye, observed in rats and not in other species, are relevant to the risk assessment for operators and consumers. Based on the field exposure studies, corroborated by information on health surveys on operators, the Committee found that when paraquat is used as a plant protection product as recommended under prescribed good working practices, its use does not pose any significant health risk for the operators. The Committee also noted that uses at recommended field rates are unlikely to pose a significant risk to soil-dwelling organisms. However, a more detailed appraisal of the likely effects of paraquat on the rate of degradation of organic material in soil was requested in view of remaining uncertainty. This information was subsequently delivered and evaluated by the rapporteur Member State. Furthermore, the Scientific Committee concluded that available studies indicate a hazard to ground-breeding birds but further information on realistic exposures is needed for a definitive assessment of the risk. This information was subsequently provided and the evaluation within the Standing Committee on the Food Chain and Animal Health concluded that there are several situations where exposure to ground-nesting birds is negligible. However, there are also scenarios where exposure may occur. The evaluation within the Standing Committee on the Food Chain and Animal Health concluded that the risk would be acceptable, provided appropriate risk-mitigation measures are applied. Finally, the Scientific Committee concluded that paraquat may be expected to cause lethal and sublethal effects for hares, but the available data are inadequate to estimate the proportion of hares affected. The views of the Scientific Committee were taken into consideration when drafting this Directive and the review report. The evaluation within the Standing Committee on the Food Chain and Animal Health concluded that the risk would be acceptable if appropriate risk-mitigation measures were applied.(5) It has appeared from the various examinations made that there are uses of plant protection products containing paraquat which may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, provided appropriate risk-mitigation measures and restrictions are applied. It is therefore appropriate to include paraquat in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive. However some uses of plant protection products containing paraquat pose an unacceptable risk and should therefore not be authorised. Moreover, it is considered appropriate to ensure that Member States impose that the notifier and any other authorisation holder of paraquat establish a stewardship programme particularly for operator safety, and that they report to the Commission yearly on incidences of operator health problems as well as possible impacts on hares. This should enable a verification of whether the risk-mitigation measures imposed by Member States really limit the possible risks for operators and hares to an acceptable level, and, if appropriate, a re-evaluation, in line with scientific progress, of the properties and potentially related risks to humans and the environment.(6) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.(7) After inclusion, Member States should be allowed a reasonable period within which to implement the provisions of Directive 91/414/EEC as regards plant protection products containing paraquat, and, in particular, to review existing authorisations to ensure that the conditions regarding those active substances set out in Annex I to Directive 91/414/EEC are satisfied. A longer period should be provided for the submission and assessment of the complete dossier of each plant protection product in accordance with the uniform principles laid down in Directive 91/414/EEC.(8) It is therefore appropriate to amend Directive 91/414/EEC accordingly.(9) 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 1Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.Article 2Member States shall adopt and publish by 30 April 2005 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.They shall apply those provisions from 1 May 2005.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 31. Member States shall review the authorisation for each plant protection product containing paraquat to ensure that the conditions relating to those active substances set out in Annex I to Directive 91/414/EEC are complied with. Where necessary and by 30 April 2005 at the latest, they shall amend or withdraw the authorisation.2. Member States shall, for each authorised plant protection product containing paraquat 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 October 2004 at the latest, 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. 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. Where necessary and by 31 July 2008 at the latest, they shall amend or withdraw the authorisation.Article 4Member States shall ensure that the authorisation holders report at the latest on 31 March 2008 on the effects of risk-mitigation measures to be applied through a stewardship programme and the implementation of advances in paraquat formulations. Member States shall submit this information without delay to the Commission.The Commission shall submit to the Standing Committee on the Food Chain and Animal Health a report on the application of the present Directive indicating whether the requirements for Annex I inclusion continue to be satisfied and may propose any amendment, including if necessary the withdrawal from Annex I, to the present Directive that it deems necessary to comply with its provisions.Article 5This Directive shall enter into force on 1 November 2004.Article 6This Directive is addressed to the Member States.Done at Brussels, 1 December 2003.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1.(2) OJ L 247, 30.9.2003, p. 20.(3) OJ L 366, 15.12.1992, p. 10.(4) OJ L 259, 13.10.2000, p. 27.(5) OJ L 107, 28.4.1994, p. 8.(6) OJ L 225, 22.9.1995, p. 1.(7) Opinion of the Scientific Committee on Plants on specific questions from the Commission regarding the evaluation of paraquat in the context of Council Directive 91/414/EEC; SCP/PARA/002 adopted on 20 December 2001.ANNEXThe following entries shall be added at the end of the table in Annex I to Directive 91/414/EEC">TABLE>"


Avis juridique important

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32002L0048

Commission Directive 2002/48/EC of 30 May 2002 amending Council Directive 91/414/EEC to include iprovalicarb, prosulfuron and sulfosulfuron as active substances

Official Journal L 148 , 06/06/2002 P. 0019 - 0023

Commission Directive 2002/48/ECof 30 May 2002amending Council Directive 91/414/EEC to include iprovalicarb, prosulfuron and sulfosulfuron as active substancesTHE 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 2002/37/EC(2), and in particular Article 6(1) thereof,Whereas:(1) In accordance with Article 6(2) of Directive 91/414/EEC, Ireland received on 30 March 1998 an application from Bayer AG for the inclusion of the active substance iprovalicarb in Annex I to the Directive. By Commission Decision 98/512/EC(3) it was confirmed that the dossier was "complete" in the sense that it could be considered as satisfying, in principle, the data and information requirements laid down in Annexes II and III to Directive 91/414/EEC.(2) France received a similar application on 14 May 1995 from Novartis, now Syngenta, concerning prosulfuron. This application was declared complete by Commission Decision 97/137/EC(4).(3) Ireland received a similar application on 24 April 1997 from Monsanto concerning sulfosulfuron. This application was declared complete by Commission Decision 97/865/EC(5).(4) For these three active substances, the effects on human health and the environment have been assessed, in accordance with Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The nominated rapporteur Member States submitted draft assessment reports concerning the substances to the Commission on 4 November 1999 (iprovalicarb), 18 January 1999 (prosulfuron), and 2 April 1998 (sulfosulfuron), respectively.(5) The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The reviews were finalised on 26 February 2002 in the format of the Commission review reports for iprovalicarb, prosulfuron and sulfosulfuron.(6) The dossier and the information from each of the reviews were submitted to the Scientific Committee for Plants. As regards iprovalicarb, the Committee was asked to comment on the acceptability of the risk of metabolite PMPA on earthworms and on the relevance to humans of tumours which were observed in rats after lifetime exposure to high doses. In two opinions(6)(7), the Committee identified the need for further data on earthworms, which were subsequently provided and assessed, and concluded that concerning the effects observed in rats sufficient safety margins exist to ensure protection of consumers and operators. The observations of the Scientific Committee were taken into consideration in formulating this Directive and the relevant review report.(7) With respect to prosulfuron, the Committee was asked to comment on the acceptability of the risk of two breakdown products of the active substance to sediment dwelling organisms and on possible hormonal disruption effects observed in test animals. In its opinion(8) the Committee concluded that certain uterine and mammary changes, which were observed in rats after lifetime exposure are not considered relevant for human risk assessment of prosulfuron in the context of its intended uses. The Committee further commented that risks of the two breakdown products to sediment-dwelling species were not yet adequately assessed and noted that other persistent metabolites are formed in significant quantities in sediment-water tests which also did not appear to have been assessed. The pending information and assessments were subsequently provided and the observations of the Scientific Committee were taken into consideration in formulating this Directive and the relevant review report.(8) With respect to sulfosulfuron the Committee was asked for its opinion on the occurrence of bladder tumours in the 18 months mouse study; to consider whether it would be appropriate to establish an acute reference dose for sulfosulfuron; to confirm that a sub-lethal study for earthworms is unnecessary, notwithstanding the persistence of the soil metabolites. In its opinion(9) the Committee considered that the lesions observed in mice do not predict a carcinogenic hazard to humans and saw no need to establish an acute reference dose. It was further concluded that no significant long term risks to earthworms are likely to arise. The Committee further highlighted the need to assess the potential environmental impact of three unidentified metabolites. This information was subsequently provided and the requested assessments were made.(9) It has appeared from the various examinations made that plant protection products containing the active substances concerned 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 reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing the active substances concerned, can be granted in accordance with the provisions of the said Directive.(10) The Commission review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Directive 91/414/EEC. It is, therefore, appropriate to provide that the finalised review reports, except for confidential information, should be kept available or made available by the Member States for consultation by any interested parties.(11) After inclusion, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing iprovalicarb, prosulfuron or sulfosulfuron and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC.(12) It is therefore appropriate to amend Directive 91/414/EEC accordingly.(13) 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 1Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.Article 2Member States shall keep available the review reports for iprovalicarb, prosulfuron, and sulfosulfuron, except for confidential information within the meaning of Article 14 of Directive 91/414/EEC, for consultation by any interested parties or shall make it available to them on specific request.Article 3Member States shall adopt and publish by 31 December 2002 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.They shall apply those provisions from 1 January 2003.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 41. Member States shall review the authorisation for each plant protection product containing iprovalicarb, prosulfuron, or sulfosulfuron, to ensure that the conditions relating to these active substances set out in Annex I to Directive 91/414/EEC are complied with. Where necessary, they shall amend or withdraw the authorisation in accordance with Directive 91/414/EEC before 31 December 2002.2. Member States shall, for each authorised plant protection product containing iprovalicarb, prosulfuron, or sulfosulfuron, 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 1 July 2002, 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 thereto. 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. Where necessary and by 31 December 2003 at the latest, they shall amend or withdraw the authorisation for each such plant protection product.Article 5This Directive shall enter into force on 1 July 2002.Article 6This Directive is addressed to the Member States.Done at Brussels, 30 May 2002.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1.(2) OJ L 117, 4.5.2002, p. 10.(3) OJ L 228, 15.8.1998, p. 35.(4) OJ L 52, 22.2.1997, p. 20.(5) OJ L 351, 23.12.1997, p. 67.(6) Opinion of the Scientific Committee on Plants on the evaluation of iprovalicarb in the context of Directive 91/414/EEC concerning the placing of plant protection products on the market (adopted 21 March 2001).(7) Opinion of the Scientific Committee on Plants on an additional question from the Commission on the evaluation of iprovalicarb (SZX 0722) in the context of Directive 91/414/EEC (adopted 28 November 2001).(8) Opinion of the Scientific Committee on Plants regarding the inclusion of prosulfuron (CGA 152005) in Annex I to Directive 91/414/EEC concerning the placing of plant protection products on the market SCP/PROSULF/002-Final 21 June 2001.(9) Opinion of the Scientific Committee on Plants regarding the evaluation of MON 37500 (sulfosulfuron) in the context of Directive 91/414/EEC concerning the placing of plant protection products on the market (SCP/SULFO/002-final dated 11 December 2000).ANNEXIn Annex I the following rows are added to the end of the Table: " "(1) Further details on identity and specification of active substances are provided in the review report.


Important legal notice

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32003L0070

Commission Directive 2003/70/EC of 17 July 2003 amending Council Directive 91/414/EEC to include mecoprop, mecoprop-P and propiconazole as active substances (Text with EEA relevance)

Official Journal L 184 , 23/07/2003 P. 0009 - 0012

Commission Directive 2003/70/ECof 17 July 2003amending Council Directive 91/414/EEC to include mecoprop, mecoprop-P and propiconazole as active substances(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 2003/68/EC(2), and in particular Article 6(1) thereof,Whereas:(1) Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market(3), as last amended by Regulation (EC) No 2266/2000(4), establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes mecoprop, mecoprop-P and propiconazole.(2) For those active substances 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 range of uses proposed by the notifiers. By Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member State for the implementation of Regulation (EEC) No 3600/92(5), as last amended by Regulation (EC) No 2230/95(6), the following rapporteur Member States were designated, which in turn submitted the relevant assessment reports and recommendations to the Commission in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92: mecoprop: Rapporteur Member State Denmark, all relevant information was submitted on 31 August 1999; mecoprop-P: Rapporteur Member State Denmark, all relevant information was submitted on 7 January 1999; propiconazole: Rapporteur Member State Finland, all relevant information was submitted on 30 November 1998.(3) Those assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health.(4) The reviews of all active substances were finalised on 15 April 2003 in the format of the Commission review reports for mecoprop, mecoprop-P and propiconazole.(5) The reviews of mecoprop, mecoprop-P and propiconazole did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants.(6) It has appeared from the various examinations made that plant protection products containing mecoprop, mecoprop-P or propiconazole may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) 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 these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive.(7) The Commission review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Directive 91/414/EEC. It is, therefore, appropriate to provide that the finalised review report, except for confidential information, should be kept available or made available by the Member States for consultation by any interested parties.(8) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.(9) After inclusion, Member States should be allowed a reasonable period within which to implement the provisions of Directive 91/414/EEC as regards plant protection products containing mecoprop, mecoprop-P or propiconazole, and in particular, to review existing authorisations to ensure that the conditions regarding those active substances set out in Annex I to Directive 91/414/EEC are satisfied. A longer period should be provided for the submission and assessment of the complete dossier of each plant protection product 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 1Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.Article 2Member States shall adopt and publish by 30 November 2004 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.They shall apply those provisions from 1 December 2004.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 31. Member States shall review the authorisation for each plant protection product containing mecoprop, mecoprop-P or propiconazole to ensure that the conditions relating to those active substances set out in Annex I to Directive 91/414/EEC are complied with. Where necessary and by 30 November 2004 at the latest, they shall amend or withdraw the authorisation.2. Member States shall, for each authorised plant protection product containing mecoprop, mecoprop-P or propiconazole 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 May 2004 at the latest, 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. 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. Where necessary and by 31 May 2008 at the latest, they shall amend or withdraw the authorisation.Article 4This Directive shall enter into force on 1 June 2004.Article 5This Directive is addressed to the Member States.Done at Brussels, 17 July 2003.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1.(2) OJ L 177, 16.7.2003, p. 12.(3) OJ L 366, 15.12.1992, p. 10.(4) OJ L 259, 13.10.2000, p. 27.(5) OJ L 107, 28.4.1994, p. 8.(6) OJ L 225, 22.9.1995, p. 1.ANNEXThe following entries shall be added at the end of the table in Annex I to Directive 91/414/EEC.">TABLE>"


Important legal notice

|

32003L0068

Commission Directive 2003/68/EC of 11 July 2003 amending Council Directive 91/414/EEC to include trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone and isoxaflutole as active substances (Text with EEA relevance)

Official Journal L 177 , 16/07/2003 P. 0012 - 0016

Commission Directive 2003/68/ECof 11 July 2003amending Council Directive 91/414/EEC to include trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone and isoxaflutole as active substances(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 2003/39/EC(2), 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 28 January 1998 an application from Novartis Crop Protection UK Ltd for the inclusion of the active substance trifloxystrobin in Annex I to Directive 91/414/EEC. The substance was subsequently transferred to Bayer CropScience, which is now acting as the applicant. Commission Decision 1999/43/EC(3) 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) France received an application under Article 6(2) of Directive 91/414/EEC on 14 February 1996 from FMC Europe NV (now FMC Chemical sprl) concerning carfentrazone-ethyl. This application was declared complete by Commission Decision 97/362/EC(4).(3) The United Kingdom received an application under Article 6(2) of Directive 91/414/EEC on 23 April 1998 from Zeneca Agrochemicals UK (now Syngenta) concerning mesotrione. This application was declared complete by Commission Decision 1999/392/EC(5).(4) France received an application under Article 6(2) of Directive 91/414/EEC on 15 September 1999 from Rhone Poulenc Agri SA (now Bayer CropScience) concerning fenamidone. This application was declared complete by Commission Decision 2000/251/EC(6).(5) The Netherlands received an application under Article 6(2) of Directive 91/414/EEC on 6 March 1996 Rhône-Poulenc Agro (now Bayer CropScience) concerning isoxaflutole. This application was declared complete by Commission Decision 96/524/EC(7).(6) For those active substances, 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 applicants. The nominated rapporteur Member States, submitted a draft assessment report concerning the substance to the Commission on 19 April 2000 (trifloxystrobin), 14 May 1998 (carfentrazone-ethyl), 17 December 1999 (mesotrione), 14 May 1998 (fenamidone) and 20 February 1997 (isoxaflutole).(7) The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 15 April 2003 in the format of the Commission review reports for mesotrione, trifloxystrobin, carfentrazone-ethyl, fenamidone and isoxaflutole.(8) The review of trifloxystrobin and fenamidone did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee for Plants.(9) For carfentrazone-ethyl the review and information were also submitted to the Scientific Committee for Plants for separate consultation. The Committee was asked to comment on the relevance for humans of the elevated levels of specific porphyrins detected in test animals. The Committee expressed the opinion(8) that the effects of the substance detected in test animals on porphyrin levels are relevant for humans but saw no evidence that humans are more sensitive to the effect than animals. In addition, the Scientific Committee noted that three unknown polar compounds were detected in a lysimeter. The notifier was therefore requested to comment on the relevance of these three compounds. Additional information was subsequently provided by the notifier and evaluated by the Committee. In its assessment of the new data the Committee concluded that those polar compounds will not cause an unacceptable ecotoxicological or toxicological risk.(10) For mesotrione, the Scientific Committee was asked to comment on the suitability of the rat as an animal model for the extrapolation of the toxicological properties of mesotrione in humans and was invited to assess, whether the onset of adverse effects in target organs (in animal models as well as humans) can be linked to a certain threshold concentration of tyrosine in plasma. In its opinion(9), the Committee concluded that due to the similarities in tyrosine kinetics between mice and humans, the mouse can be considered a better animal model than the rat for human risk assessment purposes. The Committee further concluded that no signs or symptoms of adverse effects are to be expected in humans at plasma tyrosine levels below 800 to 1000 nmol/ml.(11) For isoxaflutole the Scientific Committee was asked to comment on the toxicological and ecotoxicological effects of a degradation product of the active substance (RPA 203328); on statistical analyses of tumour incidence in the two-year rat study; and on the observation of developmental effects in laboratory animals. In its opinion(10), the Committee noted that the degradation product RPA 203328 under worst-case conditions might leach into groundwater with expected concentrations exceeding 0,1 ppb. The Committee identified no toxicological or ecotoxiclogical concern with regard to this degradation product. The Committee also identified no concern for humans related to possible carcinogenic or developmental effects.In a second consultation on the same substances the Scientific Committee was asked to comment on the appropriate degradation kinetics to be assumed in model calculations of the leaching behaviour. The Committee found certain parameters used in the modelling were insufficiently justified and the half life time of degradation for the RPA 203328 metabolite may have been under-estimated(11).The model calculations of the leaching behaviour of isoxaflutole and its degradation products were subsequently revised along the lines suggested by the Scientific Committee.(12) It has appeared from the various examinations made that plant protection products containing the active substances concerned 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 mesotrione, trifloxystrobin, carfentrazone-ethyl, fenamidone and isoxaflutole in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substance can be granted in accordance with the provisions of that Directive.(13) After inclusion, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone and isoxaflutole and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC.(14) It is therefore appropriate to amend Directive 91/414/EEC accordingly.(15) 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 1Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.Article 2Member States shall adopt and publish by 31 March 2004 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.They shall apply those provisions from 1 April 2004.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 31. Member States shall review the authorisation for each plant protection product containing trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone or isoxaflutole to ensure that the conditions relating to these active substances set out in Annex I to Directive 91/414/EEC are complied with. Where necessary, they shall amend or withdraw authorisations in accordance with Directive 91/414/EEC by 31 March 2004 at the latest.2. For each authorised plant protection product containing trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone or isoxaflutole 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 30 September 2004 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 thereto. 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. Where necessary and by 31 March 2005 at the latest, they shall amend or withdraw the authorisation for each such plant protection product.Article 4This Directive shall enter into force on 1 October 2003.Article 5This Directive is addressed to the Member States.Done at Brussels, 11 July 2003.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1.(2) OJ L 124, 20.5.2003, p. 30.(3) OJ L 14, 19.1.1999, p. 30.(4) OJ L 152, 11.6.1999, p. 31.(5) OJ L 148, 15.6.1999, p. 44.(6) OJ L 78, 29.3.2000, p. 26.(7) OJ L 220, 30.8.1996, p. 27.(8) Opinion of the Scientific Committee for Plants regarding the evaluation of carfentrazone-ethyl in the context of Directive 91/414/EEC concerning the placing of plant protection products on the market. SCP/CARFEN/002-final adopted 26 January 2001.(9) Opinion of the Scientific Committee for Plants on the evaluation of mesotrione in the context of Directive 91/414/EEC concerning the placing of plant protection products on the market. SCP/MESOTRI/002-final of 18 July 2002.(10) Opinion of the Scientific Committee for Plants regarding the inclusion of isoxaflutole in Annex 1 of Directive 91/414/EEC concerning the placing of plant protection products on the market. SCP/ISOXA/012-final of 3 June 1999.(11) Opinion of the Scientific Committee for Plants on additional questions from the Commission concerning the evaluation of isoxaflutole in the context of Directive 91/414/EEC. SCP/ISOXAFLUTOLE-bis-002 final of 30 January 2003.ANNEXIn Annex I the following rows are added at the end of the table:">TABLE>"


title: Commission Directive (EU) 2015/2115 of 23 November 2015 amending, for the purpose of adopting specific limit values for chemicals used in toys, Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards formamide (Text with EEA relevance)

text:
               24.11.2015

               EN

               Official Journal of the European Union

               L 306/17

         COMMISSION DIRECTIVE (EU) 2015/2115
   of 23 November 2015
   amending, for the purpose of adopting specific limit values for chemicals used in toys, Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards formamide
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (1), and in particular Article 46(2) thereof,
   Whereas:

               (1)

               In order to ensure a high level of protection of children against risks caused by chemical substances in toys, Directive 2009/48/EC establishes certain requirements with regard to chemical substances such as those classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2), allergenic fragrances and certain elements. In addition, Directive 2009/48/EC empowers the Commission to adopt specific limit values for chemicals used in toys which are intended for children under 36 months and in other toys intended to be placed in the mouth in order to ensure adequate protection in the case of toys involving a high degree of exposure. The adoption of such limit values takes the form of an inclusion in Appendix C to Annex II to Directive 2009/48/EC.

               (2)

               For a number of chemicals, currently applicable limit values are either too high in the light of available scientific evidence or do not exist. Specific limit values should therefore be adopted for them, taking into account the packaging requirements for food as well as the differences between toys and food contact materials.

               (3)

               In order to advise the European Commission in the preparation of legislative proposals and policy initiatives in the area of toy safety, the Commission established the Expert Group on Toys Safety. The mission of its subgroup ‘Chemicals’ is to provide such advice with regard to chemical substances which may be used in toys.

               (4)

               Formamide (CAS number 75-12-7) is used, among others, in the plastics and polymers industry, particularly as a solvent, plasticiser or as a substance associated with a blowing agent used in the production of foam (3). In 2010, several Member States identified formamide in a range of foam toys, such as puzzle mats, which gave rise to concerns for the health of children through inhalation. Some Member States took or were considering taking regulatory action.

               (5)

               In its deliberations about formamide the subgroup ‘Chemicals’ took the opinion of the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) as a basis. The opinion recommended that emission into the air of formamide from puzzle mats be limited, so that it does not exceed 20 μg/m3 measured 28 days after unpacking and confinement in an outgassing chamber of new mats before their sale, following a test method (4) in accordance with the ISO 16000-6 and 16000-9 standards and under suitable conditions for sampling within products and batches of products.

               (6)

               The subgroup ‘Chemicals’ further considered a nursery (room volume 30 m3) with a large puzzle mat (1,2 m2, 720 g) and several other foam toys (thus adding up to 1 kg of foam toy materials exposed to the air). The air in that nursery (air exchange rate 0,5 h– 1) would contain 20 μg/m3 formamide after 28 days if the formamide content in the foam toy materials were at approximately 200 mg/kg and were completely emitted.

               (7)

               Formamide is classified under Regulation (EC) No 1272/2008 as toxic to reproduction category 1B. According to point 4 of Part III of Annex II to Directive 2009/48/EC, substances toxic to reproduction of category 1B such as formamide may be present in toys in concentrations equal to or smaller than the relevant concentration established for the classification of mixtures containing it, namely 0,5 %, which equals 5 000 mg/kg (content limit), before 1 June 2015, and 0,3 %, which equals 3 000 mg/kg (content limit) thereafter. Directive 2009/48/EC does not currently provide for an emission limit for formamide.

               (8)

               In the light of the above, the subgroup ‘Chemicals’ recommended, at its meeting of 28 November 2013, that emissions of formamide from foam toy materials be limited in Appendix C to Annex II to Directive 2009/48/EC to 20 μg/m3 after a maximum of 28 days from commencement of the emission testing. The subgroup further recommended, at its meeting of 18 February 2015, that emission testing is not necessary when the formamide content is 200 mg/kg or less (cut-off value derived in a worst-case exposure scenario).

               (9)

               There are no known uses of formamide in food contact materials to be considered.

               (10)

               The measures provided for in this Directive are in accordance with the opinion of the Committee established in Article 47 of Directive 2009/48/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   In Appendix C to Annex II to Directive 2009/48/EC, the following entry shall be added:

                  Substance

                  CAS No

                  Limit value

                  ‘Formamide

                  75-12-7

                  20 μg/m3 (emission limit) after a maximum of 28 days from commencement of the emission testing of foam toy materials containing more than 200 mg/kg (cut-off limit based on content).’

   Article 2
   1.   Member States shall adopt and publish, by 24 May 2017 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.
   They shall apply those provisions from 24 May 2017.
   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.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 23 November 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 170, 30.6.2009, p. 1.

      (2)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

      (3)  French Agency for Food, Environmental and Occupational Health & Safety (ANSES), Opinion on the uses of formamide in consumer goods and health risks related to formamide in children's foam puzzle mats. ANSES Opinion, Request No 2010-SA-0302, 4 July 2011, p. 4.

      (4)  Emission test protocol with relative humidity of 50 %, a temperature of 23 °C, an air renewal rate of 0,5 volume.h– 1, a normal room size of 30 m3 and an emissive surface for the mat of 1,2 m2.


title: Commission Directive 2010/55/EU of 20 August 2010 amending Annex I to Council Directive 91/414/EEC to renew the inclusion of azoxystrobin as active substance  Text with EEA relevance

text:
               21.8.2010

               EN

               Official Journal of the European Union

               L 220/67

         COMMISSION DIRECTIVE 2010/55/EU
   of 20 August 2010
   amending Annex I to Council Directive 91/414/EEC to renew the inclusion of azoxystrobin 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 azoxystrobin 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 azoxystrobin 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 10 June 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 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 azoxystrobin (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 azoxystrobin.

               (7)

               It has appeared from the various examinations made that plant protection products containing azoxystrobin 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 azoxystrobin 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)

               Moreover, the review has established that for the active substance azoxystrobin notified by the main data submitter the manufacturing impurity toluene is of toxicological concern and therefore its presence in the technical material must not exceed the maximum level of 2 grams for kilogram.

               (9)

               From the new data submitted, it appears that azoxystrobin may cause risks for aquatic organisms. Without prejudice to the conclusion that the inclusion of azoxystrobin is to be renewed, it is therefore appropriate to obtain further information on those 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. Therefore, it is appropriate to require that the notifier submit further information to confirm the results of the risk assessment on the basis of most recent scientific knowledge as regards the risk for groundwater contamination with respect to some minor soil transformation products and the risk for aquatic organisms.

               (10)

               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.

               (11)

               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 azoxystrobin 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.

               (12)

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

               (13)

               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 azoxystrobin 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 azoxystrobin 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 azoxystrobin 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 azoxystrobin. 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 azoxystrobin 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 azoxystrobin. 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 azoxystrobin on request from the European Commission EFSA Journal 2010; 8(4):1542.

      ANNEX
      In Annex I to Directive 91/414/EEC, row No 2 is replaced by the following:

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘2

                     Azoxystrobin
                     CAS No 131860-33-8
                     CIPAC No 571

                     methyl (E)-2-{2[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl}-3-methoxyacrylate

                        ≥ 930 g/kg

                     Toluene maximum content 2 g/kg
                     Z-isomer maximum content 25 g/kg

                     1 August 2011

                     31 July 2021

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on azoxystrobin 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.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,

                                 —

                                 the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

                                 —

                                 the protection of aquatic organisms.

                           The Member States must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones.
                     The Member States concerned shall request the submission of further studies to finalise the risk assessment on groundwater and aquatic organisms. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2012.’

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


title: Commission Directive 2006/45/EC of  16 May 2006  amending Council Directive 91/414/EEC as regards the specification of the active substance propoxycarbazone   (Text with EEA relevance)

text:
               18.5.2006

               EN

               Official Journal of the European Union

               L 130/27

      COMMISSION DIRECTIVE 2006/45/EC
   of 16 May 2006
   amending Council Directive 91/414/EEC as regards the specification of the active substance propoxycarbazone
   (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), and in particular the second indent of the second subparagraph of Article 6(1) thereof,
   Whereas:

               (1)

               By Commission Directive 2003/119/EC (2) propoxycarbazone was included as active substance in Annex I to Directive 91/414/EEC.

               (2)

               When applying for the inclusion of propoxycarbazone its manufacturer Bayer CropScience gave a specification based on small-scale production. For large-scale production, that company now intends to modify the specification as regards purity. It has submitted data to show that the modified specification fulfils the requirements for inclusion.

               (3)

               Germany evaluated the information and data submitted by the company. It informed the Commission in July 2005 that it concludes that the modified specification does not cause any risks in addition to those already taken into account in the entry for propoxycarbazone in Annex I to Directive 91/414/EEC and in the Commission review report for that substance.

               (4)

               Therefore it is justified to modify the specification of propoxycarbazone.

               (5)

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

               (6)

               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 18 September 2006 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 19 September 2006.
   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
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 16 May 2006.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2006/39/EC (OJ L 104, 13.4.2006, p. 30).

      (2)  OJ L 325, 12.12.2003, p. 41.

      ANNEX
      In Annex I to Directive 91/414/EEC, row 77 is replaced by the following:

                     ‘77

                     Propoxycarbazone
                     CAS No 145026-81-9
                     CIPAC No 655

                     2-(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-1,2,4-triazol-1-yl) carboxamidosulfonylbenzoicacid-methylester

                     ≥ 950 g/kg (expressed as propoxy-carbazone-sodium)

                     1 April 2004

                     31 March 2014

                     Only uses as herbicide may be authorised.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on propoxycarbazone, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2003 shall be taken into account. In this overall assessment Member States

                                 —

                                 should pay particular attention to the potential of propoxycarbazone and its metabolites for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions,

                                 —

                                 should pay particular attention to the protection of aquatic ecosystems, especially of aquatic plants.

                           Risk mitigation measures should be applied where appropriate.’


Avis juridique important

|

31975L0502

Commission Directive 75/502/EEC of 25 July 1975 limiting the marketing of seed of smooth-stalk meadow grass (Poa pratensis L.) to seed which has been officially certified 'basic seed' or 'certified seed'

Official Journal L 228 , 29/08/1975 P. 0026 - 0026 Finnish special edition: Chapter 3 Volume 6 P. 0151  Greek special edition: Chapter 03 Volume 13 P. 0134  Swedish special edition: Chapter 3 Volume 6 P. 0151

++++( 1 ) OJ NO 125 , 11 . 7 . 1966 , P . 2298/66 .  ( 2 ) OJ NO L 356 , 27 . 12 . 1973 , P . 79 .  COMMISSION DIRECTIVE OF 25 JULY 1975 LIMITING THE MARKETING OF SEED OF SMOOTH-STALK MEADOWGRASS ( POA PRATENSIS L . ) TO SEED WHICH HAS BEEN OFFICIALLY CERTIFIED " BASIC SEED " OR " CERTIFIED SEED "  ( 75/502/EEC )  THE COMMISSION OF THE EUROPEAN COMMUNITIES ,  HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY ;  HAVING REGARD TO THE COUNCIL DIRECTIVE OF 14 JUNE 1966 ( 1 ) ON THE MARKETING OF FODDER PLANT SEED , AS LAST AMENDED BY THE COUNCIL DIRECTIVE OF 11 DECEMBER 1973 ( 2 ) , IN PARTICULAR ARTICLE 3 ( 3 ) THEREOF ;  WHEREAS THE ABOVEMENTIONED DIRECTIVE PERMITS THE MARKETING OF BASIC , CERTIFIED AND COMMERCIAL SEED OF SMOOTH-STALK MEADOWGRASS ( POA PRATENSIS L . ) ;  WHEREAS ARTICLE 3 ( 3 ) OF THE DIRECTIVE AUTHORIZES THE COMMISSION TO PROHIBIT THE MARKETING OF FODDER PLANT SEED UNLESS IT HAS BEEN OFFICIALLY CERTIFIED AS " BASIC SEED " OR " CERTIFIED SEED " ;  WHEREAS THE MEMBER STATES NOW PRODUCE SUFFICIENT AMOUNTS OF BASIC AND CERTIFIED SEED TO SATISFY THE DEMAND FOR SEED OF SMOOTH-STALK MEADOWGRASS INSIDE THE COMMUNITY ;  WHEREAS IT IS CONSEQUENTLY APPROPRIATE TO ADMIT NO LONGER THE MARKETING OF SMOOTH-STALK MEADOWGRASS AFTER THE STOCKS RESULTING FROM CURRENT PRODUCTION CONDITIONS HAVE BEEN USED UP ;  WHEREAS THE MEASURES PROVIDED FOR IN THIS DIRECTIVE ARE IN ACCORDANCE WITH THE OPINION OF THE STANDING COMMITTEE ON SEEDS AND PROPAGATING MATERIAL FOR AGRICULTURE , HORTICULTURE AND FORESTRY ,  HAS ADOPTED THIS DIRECTIVE :  ARTICLE 1  THE MEMBER STATES PROVIDE THAT FROM 1 JULY 1976 IT IS NO LONGER PERMITTED TO MARKET SEED OF SMOOTH-STALK MEADOWGRASS ( POA PRATENSIS L . ) UNLESS IT HAS BEEN OFFICIALLY CERTIFIED AS " BASIC SEED " OR " CERTIFIED SEED " .  ARTICLE 2  THE MEMBER STATES SHALL , NOT LATER THAN 1 JULY 1976 , BRING INTO FORCE THE LAWS , REGULATIONS OR ADMINISTRATIVE PROVISIONS NECESSARY TO COMPLY WITH THIS DIRECTIVE . THEY SHALL FORTHWITH INFORM THE COMMISSION THEREOF .  ARTICLE 3  THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .  DONE AT BRUSSELS , 25 JULY 1975 .  FOR THE COMMISSION  P.J . LARDINOIS  MEMBER OF THE COMMISSION


Avis juridique important

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31992L0036

Council Directive 92/36/EEC of 29 April 1992 amending, with regard to African horse sickness, Directive 90/426/EEC on animal health conditions governing the movement and import from third countries of equidae

Official Journal L 157 , 10/06/1992 P. 0028 - 0029 Finnish special edition: Chapter 3 Volume 42 P. 0135  Swedish special edition: Chapter 3 Volume 42 P. 0135

COUNCIL DIRECTIVE 92/36/EEC of 29 April 1992 amending, with regard to African horse sickness, Directive 90/426/EEC on animal health conditions governing the movement and import from third countries of equidaeTHE COUNCIL OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 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),  Wheres Directive 90/426/EEC (4) lays down animal health conditions governing the movement and import from third countries of equidae; whereas the said Directive indicates the limits of the territory infected with African horse sickness and the rules  applicable to Member States not free from the disease;  Whereas Directive 92/35/EEC (5) has laid down the control rules; whereas Directive 90/426/EEC must be amended accordingly in order to take account of these provisions,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Article 5 of Directive 90/426/EEC shall be replaced by the following:  'Article 5 1. A Member State which is not free of African horse sickness within the meaning of Article 2 (f) may dispatch equidae from that part of its territory which is considered to be infected within the meaning of paragraph 2 of this Article only under the  conditions set out in paragraph 3 of this Article.  2. (a) A part of the territory of a Member State shall be considered to be infected with African horse sickness if:  - clinical, serological (in unvaccinated animals) and/or epidemiological evidence has revealed the presence of African horse sickness in the past two years, or - vaccination against African horse sickness has been carried out in the past 12 months.  (b) The part of the territory considered to be infected with African horse sickness must comprise as a minimum:  - a protection zone with a radius of at least 100 km around any centre of infection,  - a surveillance zone at least 50 km extending beyond the protection zone, in which no vaccination has been carried out in the last 12 months.  (c) The rules controlling the combat measures relating to the territories and zones referred to in points (a) and (b) and the relevant derogations are specified in Directive 92/35/EEC (6)().  (d) All vaccinated equidae found in the protection zone must be registered and identified in accordance with Article 6 (1) of Directive 92/35/EEC.  The identification document and/or health certificate shall carry a clear reference to such vaccination.  3. A Member State may dispatch from the territory referred to in paragraph 2 (b) only equidae which meet the following requirements:  (a) they must be dispatched only during certain periods of the year, having regard to the activity of vector insects, to be determined in accordance with the procedure laid down in Article 25;  (b) they must show no clinical symptom of African horse sickness on the day of the inspection referred to in Article 4 (1);  (c) - if they have not been vaccinated against African horse sickness, they must have undergone and reacted negatively to a complement fixation test for African horse sickness as described in Annex D, on two occasions, with an interval of between 21 and  30 days between the two tests, the second of which must have been carried out during the 10 days prior to dispatch,  - if they have been vaccinated, they must not have undergone vaccination during the previous two months and must have undergone the fixation test described in Annex D at the aforementioned intervals without having recorded an increase in the antibody  count. Under the procedure laid down in Article 24, the Commission may, following the opinion of the Scientific Veterinary Committee, recognize other monitoring methods;  (d) they must have been kept in a quarantine station for a minimum period of 40 days prior to dispatch;  (e) they must have been protected from vector insects during the period of quarantine and during transportation from the quarantine station to the place of dispatch.  (7)() OJ No L 157, 10. 6. 1992, p. 19.' Article 2  Commission Decisions 90/552/EEC (8), 90/553/EEC (9), 91/93/EEC (10) and 92/101/EEC (11) shall continue to apply for the purposes of this Directive.  Under the procedure laid down in Article 19 of Directive 92/35/EEC, the abovementioned Decisions may be amended with a view to adapting their scope to the provisions of this Directive or with a view to their future adaptation to scientific and  technological developments.  Article 3  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 31 December 1992. The shall forthwith inform the Commission thereof.  When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member  States.  Article 4  This Directive is addressed to the Member States.  Done at Luxembourg, 29 April 1992.  For the Council The President Arlindo MARQUES CUNHA (1) OJ No C 312, 3. 12. 1991, p. 17.(2) Opinion delivered on 10 April 1992 (not yet published in the Official Journal).(3) Opinion delivered on 22 April 1992 (not yet published in the Official Journal).(4) OJ No L 224, 18. 8. 1990, p. 42.(5)  See page 19 of this Official Journal.(6) Commission Decision 90/552/EEC of 9 November 1990 determining the limits of the territory infected with African horse sickness (OJ No L 313, 13. 11. 1990, p. 38). Decision as amended by Decision 91/645/EEC (OJ No  L 349, 18. 12. 1991, p. 43).(7) Commission Decision 90/553/EEC of 9 November 1990 establishing the identification mark for equidae vaccinated against African horse sickness (OJ No L 313, 13. 11. 1990, p. 40).(8) Commission Decision 91/93/EEC of 11  February 1991 determining the period of the year during which Portugal may dispatch certain equidae from the part of its territory considered to be infected with African horse sickness (OJ No L 50, 23. 2. 1991, p. 27).(9) Commission Decision 92/101/EEC  of 28 January 1992 determining the period of the year during which Spain may dispatch certain equidae from the part of its territory considered to be infected with African horse sickness (OJ No L 39, 15. 2. 1992, p. 46).