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32000L0080

Commission Directive 2000/80/EC of 4 December 2000 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market, so as to consolidate that Annex and include a further active substance (lambda-cyhalothrin)

Official Journal L 309 , 09/12/2000 P. 0014 - 0023

Commission Directive 2000/80/ECof 4 December 2000amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market, so as to consolidate that Annex and include a further active substance (lambda-cyhalothrin)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 2000/68/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), 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"). Pursuant to that Regulation, Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member States for the implementation of Commission Regulation (EEC) No 3600/92(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.(2) 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, nor 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.(3) For lambda-cyhalothrin 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. Sweden was designated as rapporteur Member State under Commission Regulation (EC) No 491/95(7) amending Regulation (EEC) No 3600/92 and Regulation (EC) No 933/94, in particular with regard to the integration of the designated public authorities and the producers in Austria, Finland and Sweden in the implementation of the first stage of the programme of work referred to in Article 8(2) of the Directive. Sweden submitted the relevant assessment report and recommendation to the Commission on 12 June 1996, in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92.(4) That assessment report has been reviewed by the Member States and the Commission within the Standing Committee on Plant Health. That review was finalised on 19 October 2000 in the format of the Commission review report for lambda-cyhalothrin. If the review report has to be updated to take account of technical and scientific developments, the conditions for the inclusion of lambda-cyhalothrin in Annex I to the Directive will also need to be amended in accordance with the Directive.(5) The dossier and the information from the review have also been submitted to the Scientific Committee on Plants for consultation. In its opinion of 28 January 2000(8), the Committee noted that an acute dietary risk assessment for consumers should be conducted and an acute reference dose should be defined. Further, with regard to the protection of the environment, the Committee emphasised that appropriate risk mitigation measures must be applied to avoid unacceptable effects on aquatic organisms and non-target arthropods including bees. Those recommendations were taken into consideration in the measures provided for in this Directive and in the relevant review report.(6) 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) and (b) of the Directive, in particular with regard to the uses which were examined and detailed in the 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.(7) The Directive provides that after inclusion of an active substance in Annex I, Member States must, within a prescribed period, grant, vary or withdraw, as appropriate, the authorisations of the plant protection products containing the active substance. In particular, plant protection products should not be authorised 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 the Directive on the basis of a dossier satisfying the prescribed data requirements.(8) A reasonable period must be provided for 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. Moreover, after inclusion, a reasonable period is necessary to permit Member States to implement the provisions of the Directive on plant protection products containing lambda-cyhalothrin. In particular, Member States must, within that period, review existing authorisations and, where appropriate, grant new authorisations in accordance with the provisions of the Directive. 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 the Directive. 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.(9) It is appropriate to provide that the finalised review report (except for confidential information) 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 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) A number of substances have been included in Annex I to the Directive by a series of Commission Directives, namely Directive 97/73/EC(9), 98/47/EC(10), 1999/1/EC(11), 1999/73/EC(12), 1999/80/EC(13), 2000/10/EC(14), 2000/49/EC(15), 2000/50/EC(16). For the sake of clarity and rationality, the details concerning those substances should be set out in tabular form and those Directives should be repealed without prejudice to the obligations of the Member States concerning the time limits for transposition and application set out in Annex II.(12) To ensure consistency and uniform application, it is appropriate to provide that the finalised review report on each substance should be taken into account in applying the uniform principles for the evaluation and authorisation of plant protection products under Annex VI to the Directive. Similarly, all review reports (except for confidential information) should be kept available or made available by the Member States for consultation by any interested parties.(13) 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 1Annex I to Directive 91/414/EEC is replaced by the text in Annex I to this Directive.Article 21. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 2002 at the latest. They shall forthwith inform the Commission thereof.In particular they shall, in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing lambda-cyhalothrin as an active substance by that date.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. 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 deadline for amending or withdrawing authorisations for plant protection products containing lambda-cyhalothrin as the only active substance shall be 1 January 2006.3. For plant protection products containing lambda-cyhalothrin together with another active substance which is in Annex I to Directive 91/414/EEC, the period for amending or withdrawing authorisations shall expire four years after the entry into force of the Directive which includes the last of those substances in Annex I.Article 3The Directives listed in the third column of Annex II are hereby repealed without prejudice to the obligations of the Member States concerning the transposition deadline and the specific provisions set out in Annex II.Article 4This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.The provisions in Article 2 concerning the active substance lambda-cyhalothrin together with the inclusion of this active substance in Annex I to Directive 91/414/EEC apply from 1 January 2002.Article 5This Directive is addressed to the Member States.Done at Brussels, 4 December 2000.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1.(2) OJ L 276, 28.10.2000, p. 41.(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) OJ L 49, 4.3.1995, p. 50.(8) Scientific Committee on Plants, 28.1.2000.(9) OJ L 353, 24.12.1997, p. 26.(10) OJ L 191, 7.7.1998, p. 50.(11) OJ L 21, 28.1.1999, p. 21.(12) OJ L 206, 5.8.1999, p. 16.(13) OJ L 210, 10.8.1999, p. 13.(14) OJ L 57, 2.3.2000, p. 28.(15) OJ L 197, 3.8.2000, p. 32.(16) OJ L 198, 4.8.2000, p. 39.ANNEX I"ANNEX IACTIVE SUBSTANCES AUTHORISED FOR USE IN PLANT PROTECTION PRODUCTS>TABLE>"ANNEX IIDEADLINES FOR IMPLEMENTATION MEASURES IN MEMBER STATES FOR ACTIVE SUBSTANCES AUTHORISED FOR USE IN PLANT PROTECTION PRODUCTS>TABLE>


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31990L0504

Council Directive 90/504/EEC of 9 October 1990 amending the directive 79/695/EEC on the harmonization of procedures for the release of goods for free circulation

Official Journal L 281 , 12/10/1990 P. 0028 - 0031

*****COUNCIL  DIRECTIVE  of 9 October 1990  amending the Directive 79/695/EEC on the harmonization of procedures for the release of goods for free circulation  (90/504/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,  Having regard to the proposal from the Commission (1),  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas, with regard to the procedures for the release of goods for free circulation, Title II of Directive 79/695/EEC (4), as last amended by Regulation (EEC) No 4046/89 (5), provides for special procedures, containing, in particular, in subtitles A, B and C, provisions concerning exemption from written entries, the drawing up of general, periodic or recapitulative entries and release of goods before lodging of entry;  Whereas the said provisions indicate in what manner and under what conditions the competent authorities may authorize use of simplified procedures for the release of goods for free circulation;  Whereas the conditions under which importers are entitled to use such a procedure should be defined as precisely as possible; whereas a distinction must be drawn between two types of procedure, namely the local clearance procedure and the simplified declaration procedure;  Whereas specific Community provisions apply where goods previously placed under a customs procedure with economic impact are released for free circulation;  Whereas the simplified procedures for the release of goods for free circulation are of considerable economic importance to the customs union and the internal market; whereas, in a single market, importers must be able to enjoy the same facilities irrespective of where goods are released for free circulation;  Whereas Directive 79/695/EEC should be amended accordingly;  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 79/695/EEC is hereby amended as follows:  1. Articles 16 to 20 are replaced by the following:  'Article 16  Except where Articles 16a to 22 provide otherwise, Title I shall apply to the special procedures laid down in those Articles.  Article 16a  Without prejudice to the special provisions laid down in respect of consignments sent by parcel or letter post, and with the exception of cases where an import licence, permit or certificate has to be presented, a written declaration shall, in the cases and under the conditions to be established pursuant to the procedure laid down in Article 26 (2) and (3), be unnecessary for goods imported for non-commercial purposes or goods of low value.  Article 17  1. The local clearance procedure shall enable goods to be released for free circulation at the premises of the person concerned or at other places designated or approved by the competent authorities.  The simplified declaration procedure shall enable goods to be released for free circulation on presentation of a simplified declaration with later presentation of a supplementary declaration which may be of a general, periodic or recapitulative nature, as appropriate.  2. The procedures referred to in paragraph 1 shall be applied in accordance with Articles 18 to 20a and do not preclude the exercise by the customs services of any controls they deem necessary to ensure the proper conduct of operations,  LOCAL CLEARANCE PROCEDURE  Article 18  Authorization to use the local clearance procedure shall be granted in accordance with the conditions and in the manner laid down in Articles 18a, 18b and 18c  to any person who wishes to have goods released for free circulation at his premises or at other places designated or approved by the competent authorities, who submits a written request to this end containing all the particulars necesary for the grant of the authorization  - in respect of goods subject to the Community transit procedure and in respect of which the person referred to above is authorized to use the simplified procedures to be carried out at the office of destination in accordance with Articles 71 to 77 of Commission Regulation (EEC) No 1062/87 (1), as last amended by Regulation (EEC) No 1159/89 (2);  - in respect of goods previously placed under a customs procedure with economic impact, without prejudice to the relevant specific provisions applicable;  - in respect of goods which are consigned, after having been presented to customs pursuant to Article 5 of Regulation (EEC) No 4151/88 (3), to those premises or places, in accordance with a transit procedure other than that referred to in the first indent;  - in respect of goods which are bought into the customs territory of the Community with an exemption from the requirement that they be presented to customs, pursuant to Article 6 (b) of Regulation (EEC) No 4151/88.  (1) OJ No L 107, 22. 4. 1987, p. 1.  (2) OJ No L 119, 29. 4. 1989, p. 1.  (3) OJ No L 367, 31. 12. 1988, p. 1.  Article 18a  1. The authorization referred to in Article 18 shall be granted provided that:  - the applicant's records enable the customs authorities to carry out an effective check, in particular checks at a later date,  - it is possible to guarantee an effective check on import prohibitions or restrictions or compliance with any other provisions governing release for free circulation.  2. Authorization shall in principle be refused where the applicant  - has committed a serious infringement or repeated infringements of customs rules,  - declares goods for release for free circulation only occasionally.  3. An authorization shall be revoked, when,  (a) a condition laid down for its issue has not been, or is no longer, fulfilled; or  (b) its holder fails to fulfil an obligation imposed under the arrangements.  However, the customs authority may refrain from revoking the authorization when:  - the holder fulfils his obligations within any time limit set by the customs authority, or  - the failure to fulfil an obligation is without any real consequence as regards the correct operation of the arrangements.  4. An authorization shall, in principle, also be revoked where the case referred to in the first indent of paragraph 2 arises.  5. An authorization may be revoked where the case referred to in the second indent of paragraph 2 arises.  6. The customs authorities shall set out the grounds for decisions refusing or revoking authorization.  Article 18b  1. To enable the competent authorities to satisfy themselves as to the proper conduct of operations, the authorized person referred to in Article 18 shall, upon arrival of the goods at the place designated for that purpose:  (a) duly notify the competent authorities of such arrival in the form and manner specified by them for the purpose of obtaining release of the goods;  (b) enter the said goods in his records. Such entry may be replaced by any other formality laid down by the competent authorities and offering similar guarantees. The entry shall indicate the date on which it is made and the particulars necessary for identification of the goods; such entry or the act in place of it has the same force in law as the acceptance of the declaration referred to in Article 3;  (c) make available to the competent authorities all documents, the production of which may be required for the application of the Community provisions governing the release of goods for free circulation.  2. On condition that checking on the proper conduct of operations is not thereby affected, the competent authorities may:  (a) permit the notification referred to in paragraph 1 (a) to be effected as soon as the arrival of the goods becomes imminent; (b) in certain special circumstances, where the nature of the goods in question and the rapid rate of importation operations so warrants, exempt the authorized person from the obligation to notify the competent customs office of each arrival of goods, on condition that he provides that office with all the information which it deems necessary to enable it to exercise, where appropriate, its right to examine the goods. In that case, entry of the goods in the records of the person concerned shall be equivalent to their release.  Article 18c  The authorization referred to in Article 18 shall set out the practical details for the functioning of the procedure and in particular:  - the goods to which it applies,  - the form of the obligations referred to in Article 18b, as well as the reference to the guarantee to be provided by the person concerned,  - the time of release of the goods,  - the time limit within which the declaration referred to in Article 3, which may be of a general, periodic or recapitulative nature as appropriate, must be presented to the competent customs office designated for that purpose,  - the conditions under which goods are to be covered by general, periodic or recapitulative declarations, as appropriate.  SIMPLIFIED DECLARATION PROCEDURE  Article 19  1. The declarant shall, upon request, be authorized, in accordance with the conditions and in the manner laid down in Articles 20 and 20a, to make the declaration for release for free circulation in a simplified from where goods are presented to customs,  Such simplified declaration may be in the form  - either of an incomplete entry of the type referred to in Article 6, or  - of an administrative or commercial document containing the particulars necessary for identification of the goods.  The simplified declaration shall be accompanied by all documents the production of which may be required to secure the release of the goods for free circulation.  2. The request referred to in paragraph 1 must be made in writing and contain all the particulars necessary for the grant of the authorization.  3. Statements made in supplementary declarations, together with the statements made in the simplified declarations to which they relate, shall be deemed to constitute a single indivisible instrument taking effect at the date on which the corresponding initial declaration was accepted.  4. This Article shall be without prejudice to specific provisions applicable in the case of release for free circulation of goods which have been placed under a customs procedure with economic impact.  Article 20  1. The authorization referred to in Article 19 shall be granted to the person in whose name the declaration for release for free circulation is made on condition that it is possible to guarantee an effective check on and compliance with import prohibitions or restrictions or other provisions governing release for free circulation.  2. Such authorization shall in principle be refused where the person who has made the application:  - has committed a serious infringement or repeated infringements of customs rules,  - declares goods for release for free circulation only occasionally.  It may be refused where the person in question acts on behalf of another person who declares goods for release for free circulation only occasionally.  3. The authorization shall be revoked where the condition referred to in paragraph 1 ceases to be fulfilled. It may also be revoked where the cases referred to in paragraph 2 arise.  4. The customs authorities shall set out the grounds for decisions refusing or revoking authorization.  Article 20a  The authorization referred to in Article 19 shall:  - designate th  customs office(s) which accept simplified declarations,  - specify the form and content of the simplified declarations,  - specify the goods to which they apply as well as the particulars which must appear on the simplified declaration for the purposes of identifying the goods,  - make reference to the guarantee to be provided by the person concerned.  It shall also specify the form and content of the supplementary declarations, which may be of a general, periodic or recapitulative nature, as appropriate, and fix the time limits within which they must be lodged with the competent authority to be designated.' 2. In the headings which precede Articles 21 and 22, the letters (D) and (E) are deleted.  3. Article 26 (1) is replaced by the following:  'The provisions necessary for applying this Directive shall be adopted in accordance with the procedure laid down in paragraphs 2 and 3.'  Article 2  Member States shall take the measures necessary to comply with this Directive before 1 January 1993.  Member States shall communicate these measures to the Commission.  Article 3  This Directive is addressed to the Member States.  Done at Luxembourg, 9 October 1990.  For the Council  The President  P. ROMITA  (1) OJ No C 235, 13. 9. 1989, p. 16.  (2) OJ No C 38, 19. 2. 1990, p. 49 and  OJ No C 260, 15. 10. 1990.  (3) OJ No C 62, 12. 3. 1990, p. 5.  (4) OJ No L 205, 13. 8. 1979, p. 19.  (5) OJ No L 388, 30. 12. 1989, p. 24.


title: Commission Directive 2006/132/EC of 11 December 2006 amending Council Directive 91/414/EEC to include procymidone as active substance   (Text with EEA relevance)

text:
               12.12.2006

               EN

               Official Journal of the European Union

               L 349/22

      COMMISSION DIRECTIVE 2006/132/EC
   of 11 December 2006
   amending Council Directive 91/414/EEC to include procymidone as 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), 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 (2) 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 procymidone.

               (2)

               For procymidone 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. 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 Commission Regulation (EEC) No 3600/92 (3), France was designated as Rapporteur Member State. France submitted the relevant assessment report and recommendations to the Commission on 15 January 2001 in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92.

               (3)

               The assessment report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health.

               (4)

               It has appeared from the various examinations made that plant protection products containing procymidone may be expected to satisfy the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, with regard to the uses which were examined and detailed in the Commission review report, provided that adequate risk mitigation measures are applied. As procymidone is a hazardous substance, its use should not be unrestricted. In particular there are concerns about its intrinsic toxic effects, including potential endocrine disrupting properties. There is at present no scientific consensus on the exact extent of the risk. Applying the precautionary principle, and taking into account the current state of scientific knowledge, risk mitigation measures should be imposed in order to achieve the high level of protection of human and animal health and the environment chosen in the Community.

               (5)

               Articles 5(4) and 6(1) of Directive 91/414/EEC provide that inclusion of a substance in Annex I may be subject to restrictions and conditions. In this case, restrictions on the inclusion period and on the authorised crops are deemed necessary. The original measures presented to the Standing Committee on the Food Chain and Animal Health, proposed the restriction of the inclusion period to seven years, so that Member States would give priority to reviewing plant protection products already on the market containing procymidone. In order to avoid discrepancies in the high level of protection sought, the inclusion in Annex I to Directive 91/414/EEC was intended to be limited to the uses of procymidone that have been actually assessed within the Community evaluation and for which the proposed uses were considered to comply with the conditions of Directive 91/414/EEC. This implies that other uses, which were not or only partially covered by this assessment, had first to be subject to a complete assessment, before their inclusion in Annex I of Directive 91/414/EEC could be considered. Finally, due to the hazardous nature of procymidone, it was considered necessary to provide for a minimum harmonisation at Community level of certain risk mitigation measures that were to be applied by Member States when granting authorisations.

               (6)

               Under the procedures laid down by Directive 91/414/EEC, the approval of active substances, including the definition of risk management measures, is decided by the Commission. Member States bear the responsibility for the implementation, application and control of the measures intended to mitigate the risks generated by plant protection products. Concerns expressed by several Member States reflect their judgment that additional restrictions are necessary to reduce the risk to a level that can be considered acceptable and consistent with the high level of protection that is sought within the Community. At present, it is a question of risk management to set the adequate level of safety and protection for the continued production, commercialisation and use of procymidone.

               (7)

               As a consequence of the above, the Commission re-examined its position. In order to correctly reflect the high level of protection of human and animal health and a sustainable environment sought in the Community, it considered appropriate, in addition to the principles set out in recital 5, to further reduce the period of inclusion to 18 months instead of seven years. This further reduces any risk by ensuring a priority re-assessment of this substance.

               (8)

               It may be expected that plant protection products containing procymidone satisfy the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, with regard to the uses which were examined and detailed in the Commission review report and providing that the necessary risk mitigation measures are applied.

               (9)

               Without prejudice to the conclusion that plant protection products containing procymidone may be expected to satisfy the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, it is appropriate to obtain further information on certain specific points. The potential endocrine-disrupting properties of procymidone have been assessed in test which follow the best currently available practice. The Commission is aware that the Organisation for Economic Cooperation and Development (OECD) is developing test guidelines in order to further refine the assessment of potential endocrine disrupting properties. Therefore it is appropriate to require that procymidone should be subjected to such further testing as soon as agreed OECD test guidelines exist and that such studies should be presented by the notifier. In addition, Member States should require authorisation holders to provide information on the use of procymidone including any information on incidences on operator health.

               (10)

               As with all substances included in Annex I to Directive 91/414/EEC, the status of procymidone could be reviewed pursuant to Article 5(5) of that Directive in the light of any new data becoming available. Equally, the fact that the inclusion of this substance in Annex I expires on a particular date does not prevent the inclusion being renewed according to the procedures laid down in the Directive.

               (11)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.

               (12)

               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.

               (13)

               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 six months after inclusion to review existing authorisations of plant protection products containing procymidone 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 vary, replace or withdraw, as appropriate, existing authorisations. 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. Given the hazardous properties of procymidone, the period for Member States to verify whether plant protection products containing procymidone, alone or in combination with other authorised active substances, comply with the provisions of Annex VI should not exceed 18 months.

               (14)

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

               (15)

               The Standing Committee on the Food Chain and Animal Health did not deliver an opinion within the time limit laid down by its Chairman and the Commission therefore submitted to the Council a proposal relating to these measures. On the expiry of the period laid down in the second subparagraph of Article 19(2) of Directive 91/414/EEC, the Council had neither adopted the proposed implementing act nor indicated its opposition to the proposal for implementing measures and it is accordingly for the Commission to adopt these measures,

         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 30 June 2007 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 July 2007.
   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 procymidone as an active substance by 30 June 2007. By that date they shall in particular verify that the conditions in Annex I to that Directive relating to procymidone 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.
   2.   By derogation from paragraph 1, for each authorised plant protection product containing procymidone, 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 procymidone. 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 for products containing procymidone, where necessary, amend or withdraw the authorisation by 30 June 2008.
   Article 4
   This Directive shall enter into force on 1 January 2007.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 11 December 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 2006/85/EC (OJ L 293, 24.10.2006, p. 3).

      (2)  OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regulation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 10).

      (3)  OJ L 107, 28.4.1994, p. 8. Regulation as last amended by Regulation (EC) No 2230/95 (OJ L 225, 22.9.1995, p. 1).

      ANNEX
      The following entries shall be added at the end of the table in Annex I to Directive 91/414/EEC:

                     No

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘146

                     Procymidone
                     CAS No 32809-16-8
                     CIPAC No 383

                     N-(3,5-dichlorophenyl)-1,2-dimethylcyclopropane-1,2-dicarboximide

                     985 g/kg

                     1 January 2007

                     30 June 2008

                     PART A
                     Only uses as fungicide on the following crops may be authorised:

                                 —

                                 cucumbers in greenhouses (closed hydroponic systems),

                                 —

                                 plums (for processing).

                           at rates not exceeding

                                 —

                                 0,75 g active substance per hectare per application.

                           The following uses must not be authorised:

                                 —

                                 air application,

                                 —

                                 knapsack and hand-held applications neither by amateur nor by professional users,

                                 —

                                 home gardening.

                           Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of:

                                 —

                                 aquatic organisms. Where relevant, an appropriate distance must be kept between treated areas and surface water bodies. This distance may depend on the application or not of drift reducing techniques or devices,

                                 —

                                 birds and mammals. Conditions of authorisation shall include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species,

                                 —

                                 consumers, the acute dietary exposure of which must be controlled,

                                 —

                                 groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures,

                                 —

                                 operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment,

                                 —

                                 workers, who must wear suitable protective clothing, in particular gloves, if they must enter a treated area before the specific re-entry period has expired.

                           PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on procymidone, and in particular Appendices I and II thereof, shall be taken into account.
                     Member States must ensure that the authorisation holders report at the latest on 31 December of each year on incidences of operator health problems. Member States may require that elements, such as sales data and a survey of use patterns, are provided so that a realistic picture of the use conditions and the possible toxicological impact of procymidone can be obtained.
                     Member States shall request the submission of further confirmatory data and information to prove the acceptability of the active substance when applied in situations where there is a likelihood of long term exposure of wild mammals, and on the sewage treatment applied in the case of greenhouse applications.
                     Member States shall request the submission of further studies to address the potential endocrine disrupting properties of procymidone within two years after the adoption of the Test Guidelines on endocrine disruption by the Organisation for Economic Cooperation and Development (OECD). They shall ensure that the notifier at whose request procymidone has been included in this Annex provide such studies to the Commission within two years of the adoption of the above test guidelines.’

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


Avis juridique important

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32001L0099

Commission Directive 2001/99/EC of 20 November 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include glyphosate and thifensulfuron-methyl as active substances

Official Journal L 304 , 21/11/2001 P. 0014 - 0016

Commission Directive 2001/99/ECof 20 November 2001amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include glyphosate and thifensulfuron-methyl 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 2001/87/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), 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"). Pursuant to Regulation (EEC) No 3600/92, Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member States for the implementation of Commission Regulation (EEC) No 3600/92(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.(2) For glyphosate and thifensulfuron-methyl 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. Under Regulation (EC) No 933/94, Germany and France were designated as rapporteur Member States for glyphosate and thifensulfuron-methyl, respectively. The rapporteur Member States submitted the relevant assessment reports and recommendations to the Commission on 1 February 1999 (glyphosate) and on 30 April 1996 (thifensulfuron-methyl) in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92.(3) These 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 Commission review reports for glyphosate and thifensulfuron-methyl.(4) The dossiers and the information from the reviews of glyphosate and thifensulfuron-methyl were also submitted to the Scientific Committee for Plants. 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.(5) 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) 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 substances concerned 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.(6) The Directive provides that after inclusion of an active substance in Annex I, Member States must, within a prescribed period, grant, vary or withdraw, as appropriate, the authorisations of the plant protection products containing the active substance. In particular, plant protection products should not be authorised 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 the Directive on the basis of a dossier satisfying the prescribed data requirements.(7) A reasonable period must be provided for 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. Moreover, after inclusion, a reasonable period is necessary to permit Member States to implement the provisions of the Directive on plant protection products containing glyphosate or thifensulfuron-methyl. In particular, Member States must, within that period, review existing authorisations and, where appropriate, grant new authorisations in accordance with the provisions of the Directive. 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 the Directive. 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.(8) The review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in the Directive. It is, therefore, appropriate to provide that the finalised review reports (except for confidential information) 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 substance concerned in Annex I to the Directive should also be amended in accordance with the Directive.(9) 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 1Annex I to Directive 91/414/EEC shall be amended in accordance with the Annex hereto.Article 21. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive, by 1 January 2003 at the latest. They shall forthwith inform the Commission thereof.In particular they shall, in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing glyphosate or thifensulfuron-methyl as active substance by that date.When Member States adopt this provision, 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. 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 deadline for amending or withdrawing authorisations for plant protection products containing glyphosate or thifensulfuron-methyl as the only active substance shall be 1 July 2006.3. For plant protection products containing glyphosate or thifensulfuron-methyl together with another active substance which is in Annex I to Directive 91/414/EEC, the period for amending or withdrawing authorisations shall expire four years after the entry into force of the Directive which amended Annex I so as to add the last of those substances to it.4. Member States shall keep available the review reports for glyphosate and thifensulfuron-methyl (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 3This Directive shall enter into force on 1 July 2002.Article 4This Directive is addressed to the Member States.Done at Brussels, 20 November 2001.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1.(2) OJ L 276, 19.10.2001, p. 17.(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) Minutes of the plenary of the Scientific Committee on Plants from March 7, 2001 (glyphosate).Minutes of the plenary of the Scientific Committee on Plants from June 7, 2001 (thifensulfuron-methyl)ANNEXThe following entries shall be added at the end of the table in Annex I to Directive 91/414/EEC: (1) Further details on identity and specification of active substance are provided in the review report.


title: Directive 2008/3/EC of the European Parliament and of the Council of 15 January 2008 amending Directive 2003/54/EC as regards the application of certain provisions to Estonia

text:
               22.1.2008

               EN

               Official Journal of the European Union

               L 17/6

      DIRECTIVE 2008/3/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 15 January 2008
   amending Directive 2003/54/EC as regards the application of certain provisions to Estonia
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Articles 47(2), Article 55 and Article 95 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   After consulting the Committee of the Regions,
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               During the accession negotiations, Estonia invoked the specific characteristics of its electricity sector to request a transitional period for the application of Directive 96/92/EC of the European Parliament and of the Council of 19 December 1996 concerning common rules for the internal market in electricity (3).

               (2)

               In Annex VI to the 2003 Act of Accession, Estonia was granted a transitional period until 31 December 2008 for the application of Article 19(2) of Directive 96/92/EC, relating to the gradual opening of the market.

               (3)

               Declaration No 8 annexed to the Final Act to the 2003 Treaty of Accession recognised moreover that the specific situation relating to the restructuring of the oil shale sector in Estonia was going to require particular efforts until the end of 2012.

               (4)

               Directive 96/92/EC was replaced by Directive 2003/54/EC of the European Parliament and of the Council of 26 June 2003 concerning common rules for the internal market in electricity and repealing Directive 96/92/EC (4), which had to be implemented by 1 July 2004 and which had the effect of speeding up the opening of the electricity market.

               (5)

               By letter of 17 September 2003, Estonia transmitted a request aimed at not applying Article 21(1)(b) of Directive 2003/54/EC, on the opening of the market to non-household customers, until 31 December 2012. In a further letter of 5 December 2003, Estonia indicated that it was planning to achieve the complete opening of the market provided for in Article 21(1)(c) of that Directive by 31 December 2015.

               (6)

               The request by Estonia was based on a credible restructuring plan for the oil shale sector extending until 31 December 2012.

               (7)

               Oil shale is the only real indigenous energy resource in Estonia and national production represents almost 84 % of world production. 90 % of the electricity produced in Estonia is from this solid fuel. It is therefore of great strategic importance for security of supply in Estonia.

               (8)

               The granting of a further derogation for the period 2009 to 2012 appeared necessary to guarantee security of investments in generating plants and security of supply in Estonia while allowing the serious environmental problems created by those plants to be resolved.

               (9)

               On 28 June 2004 the Council adopted Directive 2004/85/EC amending Directive 2003/54/EC of the European Parliament and of the Council as regards the application of certain provisions to Estonia (5), which granted the requested derogation.

               (10)

               By judgment of 28 November 2006 in Case C-413/04, Parliament v. Council (6), the Court of Justice annulled Directive 2004/85/EC, in so far as it granted Estonia a derogation from the application of Article 21(1)(b) and (c) of Directive 2003/54/EC going beyond 31 December 2008 and imposed a corresponding obligation to ensure only a partial opening of the market representing 35 % of consumption on 1 January 2009 and an obligation to communicate annually the consumption thresholds extending eligibility to final customers.

               (11)

               That partial annulment was not founded on reasons concerning the substance of Directive 2004/85/EC, but was due to the wrong choice of legal basis.

               (12)

               Since the reasons for granting Estonia a derogation from the application of Article 21(1)(b) and (c) of Directive 2003/54/EC going beyond 31 December 2008 remain valid, that Directive should be amended accordingly, with the same wording as in Directive 2004/85/EC but on the correct legal basis,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Article 26(3) of Directive 2003/54/EC shall be replaced by the following:

      ‘3.   Estonia shall be granted a temporary derogation from the application of Article 21(1)(b) and (c) until 31 December 2012. Estonia shall take the measures necessary to ensure the opening of its electricity market. This shall be carried out gradually over the reference period with the aim of complete opening of the market by 1 January 2013. On 1 January 2009, the opening of the market shall represent at least 35 % of consumption. Estonia shall communicate annually to the Commission the consumption thresholds extending eligibility to final customers.’

   Article 2
   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 23 January 2008. They shall forthwith inform the Commission thereof.
   When they are adopted by Member States, these measures shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
   Article 3
   This Directive shall enter into force on the day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Strasbourg, 15 January 2008.

            For the European Parliament

            The President

         H.-G. PÖTTERING

            For the Council

            The President

         J. LENARČIČ

      (1)  Opinion delivered on 24 October 2007 (not yet published in the Official Journal).

      (2)  Opinion of the European Parliament of 29 November 2007 (not yet published in the Official Journal) and Council Decision of 17 December 2007.

      (3)  OJ L 27, 30.1.1997, p. 20. Directive repealed by Directive 2003/54/EC (OJ L 176, 15.7.2003, p. 37).

      (4)  OJ L 176, 15.7.2003, p. 37. Directive as last amended by Commission Decision 2006/653/EC (OJ L 270, 29.9.2006, p. 72).

      (5)  OJ L 236, 7.7.2004, p. 10.

      (6)  ECR [2006] I-11221.