Avis juridique important

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31996L0056

Directive 96/56/EC of the European Parliament and the Council of 3 September 1996 amending Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances

Official Journal L 236 , 18/09/1996 P. 0035 - 0035

DIRECTIVE 96/56/EC OF THE EUROPEAN PARLIAMENT AND THE COUNCIL of 3 September 1996 amending Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the Economic and Social Committee (2),Acting in accordance with the procedure laid down in Article 189b of the Treaty (3),Whereas the abbreviation 'EEC` appears in certain provisions of Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (4);Whereas Article G of the Treaty on European Union replaced the term 'European Economic Community` with the term 'European Community`; whereas the abbreviation 'EEC` should therefore be replaced by the abbreviation 'EC` in the abovementioned provisions;Whereas, however, economic operators normally hold large stocks of labels; whereas certain dangerous substances validly provided with labels bearing the abbreviation 'EEC` may be stored on production sites for a relatively long period before being placed on the market; whereas such a change of abbreviation could occasion extra costs for those operators; whereas a reasonable period should therefore be set during which dangerous substances whose labels bear an 'EEC number` and the words 'EEC label` can still be placed on the market;Whereas Directive 67/548/EEC should be amended accordingly,HAVE ADOPTED THIS DIRECTIVE:Article 1 Directive 67/548/EEC is hereby amended as follows:(a) in Article 21 (2), the term 'EEC number` is hereby replaced by the term 'EC number`;(b) in Article 23 (2) (f), the term 'EEC number` is hereby replaced by the term 'EC number` and the term 'EEC label` by the term 'EC label`.However, Member States shall permit the placing on the market of substances whose labels bear the 'EEC number` and the words 'EEC label` until 31 December 2000.Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 June 1998 at the latest. They shall forthwith inform the Commission thereof.When these measures are adopted by Member States, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.Article 3 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.Article 4 This Directive is addressed to the Member States.Done at Brussels, 3 September 1996.For the European ParliamentThe PresidentK. HÄNSCHFor the CouncilThe PresidentI. YATES(1) OJ No C 73, 13. 3. 1996, p. 20.(2) Opinion delivered on 28 February 1996 (OJ No C 153, 28. 5. 1996, p. 1).(3) Opinion of the European Parliament of 13 February 1996 (OJ No C 65, 4. 3. 1996, p. 26). Council common position of 4 March 1996 (OJ No C 134, 6. 5. 1996, p. 9) and Decision of the European Parliament of 22 May 1996 (OJ No C 166, 10. 6. 1996, p. 60).(4) OJ No L 196, 16. 8. 1967, p. 1. Directive as last amended by Directive 94/69/EC (OJ No L 381, 31. 12. 1994, p. 1) and by the 1994 Act of Accession.


title: Commission Directive 2010/42/EU of 28 June 2010 amending Council Directive 91/414/EEC to include FEN 560 (fenugreek seed powder) as active substance  (Text with EEA relevance )

text:
               29.6.2010

               EN

               Official Journal of the European Union

               L 161/6

         COMMISSION DIRECTIVE 2010/42/EU
   of 28 June 2010
   amending Council Directive 91/414/EEC to include FEN 560 (fenugreek seed powder) as active substance
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               In accordance with Article 6(2) of Directive 91/414/EEC France received on 24 June 2003 an application from Société occitane de fabrications et de technologie for the inclusion of the active substance FEN 560 (also called fenugreek or fenugreek seed powder) in Annex I to Directive 91/414/EEC. Commission Decision 2004/131/EC (2) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

               (2)

               For that active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 18 February 2005.

               (3)

               The draft assessment report was peer reviewed by the Member States and the European Food Safety Authority (EFSA) in the format of the EFSA conclusion on the peer review of the pesticide risk assessment of the active substance fenugreek seed powder (FEN 560) on 18 December 2009 (3). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and was finalised on 11 May 2010 in the format of the Commission review report for FEN 560 (fenugreek seed powder).

               (4)

               It has appeared from the various examinations made that plant protection products containing FEN 560 (fenugreek seed powder) 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 FEN 560 (fenugreek seed powder) in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.

               (5)

               Without prejudice to 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 provisional authorisations of plant protection products containing FEN 560 (fenugreek seed powder) to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (6)

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

               (7)

               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 30 April 2011 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 May 2011.
   When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing FEN 560 (fenugreek seed powder) as active substance by 30 April 2011. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to FEN 560 (fenugreek seed powder) are met, with the exception of those identified in part B of the entry concerning the active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13(2) of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing FEN 560 (fenugreek seed powder) 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 2010 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning FEN 560 (fenugreek seed powder). On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing FEN 560 (fenugreek seed powder) as the only active substance, where necessary, amend or withdraw the authorisation by 30 April 2012 at the latest; or

               (b)

               in the case of a product containing FEN 560 (fenugreek seed powder) as one of several active substances, where necessary, amend or withdraw the authorisation by 30 April 2012 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

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

      Done at Brussels, 28 June 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 37, 10.2.2004, p. 34.

      (3)  The EFSA Journal (2010) 8(1):1448, Conclusion on the peer review of the pesticide risk assessment of the active substance fenugreek seed powder (FEN 560). doi:10.2903/j.efsa.2010.1448. Available online www.efsa.europa.eu

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

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘313

                     FEN 560 (also called fenugreek or fenugreek seed powder)
                     CAS No

                     None
                     CIPAC No

                     None
                     The active substance is prepared from the seed powder of Trigonella foenum-graecum L. (fenugreek).

                     Not applicable

                     100 % fenugreek seed powder without any additive and no extraction; the seed being of human food grade quality.

                     1 November 2010

                     31 October 2020

                     PART A
                     Only uses as elicitor of the crop’s self-defence mechanisms may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on FEN 560 (fenugreek seed powder), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.
                     In this overall assessment, Member States must pay particular attention to the risk to operators, workers and bystanders.
                     Conditions of authorisation shall include risk mitigation measures where appropriate.’

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


title: Commission Directive 2008/108/EC of 26 November 2008 amending Council Directive 91/414/EEC to include flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat as active substances (Text with EEA relevance)

text:
               27.11.2008

               EN

               Official Journal of the European Union

               L 317/6

      COMMISSION DIRECTIVE 2008/108/EC
   of 26 November 2008
   amending Council Directive 91/414/EEC to include flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat 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), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish 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 flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat.

               (2)

               For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 1490/2002 for a range of uses proposed by the notifiers. Moreover, those Regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 10(1) of Regulation (EC) No 1490/2002. For flutolanil the rapporteur Member State was Finland and all relevant information was submitted on 13 June 2005. For benfluralin the rapporteur Member State was Belgium and all relevant information was submitted on 16 February 2006. For fluazinam the rapporteur Member State was Austria and all relevant information was submitted on 3 January 2006. For fuberidazole and mepiquat the rapporteur Member State was the United Kingdom and all relevant information was submitted on 5 April 2005.

               (3)

               The assessment reports have been peer reviewed by the Member States and the EFSA and presented to the Commission on 3 March 2008 for flutolanil and benfluralin, on 26 March 2008 for fluazinam, on 14 November 2007 for fuberidazole and on 14 April 2008 for mepiquat in the format of the EFSA Scientific Reports (4). These reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 20 May 2008 in the format of the Commission review reports for flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat.

               (4)

               It has appeared from the various examinations made that plant protection products containing flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat 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 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 these active substances can be granted in accordance with the provisions of that Directive.

               (5)

               Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore it is appropriate to require that benfluralin should be subject to further testing for confirmation of the risk assessment for consumers and for aquatic organisms and that fluazinam should be subject to further testing for confirmation of the risk assessment for aquatic organisms and soil macro-organisms and such studies should be presented by the notifiers.

               (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)

               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 flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat 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 way of 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.

               (8)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (5) 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.

               (9)

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

               (10)

               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 31 August 2009 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 September 2009.
   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 flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat as active substances by 31 August 2009.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat 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 flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat 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 28 February 2009 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat respectively. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat as the only active substance, where necessary, amend or withdraw the authorisation by 28 February 2013 at the latest; or

               (b)

               in the case of a product containing flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat as one of several active substances, where necessary, amend or withdraw the authorisation by 28 February 2013 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 March 2009.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 26 November 2008.

            For the Commission

         Androulla VASSILIOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 55, 29.2.2000, p. 25.

      (3)  OJ L 224, 21.8.2002, p. 23.

      (4)  EFSA Scientific Report (2008) 126. Conclusion regarding the peer review of the pesticide risk assessment of the active substance flutolanil (finalised 3 March 2008).

      EFSA Scientific Report (2008) 127. Conclusion regarding the peer review of the pesticide risk assessment of the active substance benfluralin (finalised 3 March 2008).

      EFSA Scientific Report (2008) 137. Conclusion regarding the peer review of the pesticide risk assessment of the active substance fluazinam (finalised 26 March 2008).

      EFSA Scientific Report (2008) 118. Conclusion regarding the peer review of the pesticide risk assessment of the active substance fuberidazole (finalised 14 November 2007).

      EFSA Scientific Report (2008) 146. Conclusion regarding the peer review of the pesticide risk assessment of the active substance mepiquat (finalised on 14 April 2008).

      (5)  OJ L 366, 15.12.1992, p. 10.

      ANNEX
      The following entry 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

                     ‘193

                     Flutolanil
                     CAS No 66332-96-5
                     CIPAC No 524

                     α,α,α-trifluoro-3′-isopropoxy-o-toluanilide

                     ≥ 975 g/kg

                     1 March 2009

                     28 February 2019

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing flutolanil for uses other than potato tuber treatment, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on flutolanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

                           Conditions of authorisation should include risk mitigation measures, where appropriate.

                     194

                     Benfluralin
                     CAS No 1861-40-1
                     CIPAC No 285

                     N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine

                     ≥ 960 g/kg
                     Impurities:

                                 —

                                 ethyl-butyl-nitrosamine: max. 0,1 mg/kg

                     1 March 2009

                     28 February 2019

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing benfluralin for uses other than lettuce and endive, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on benfluralin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the protection of the operators' safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

                                 —

                                 the residues in food of plant and animal origin and evaluate the dietary exposure of consumers,

                                 —

                                 the protection of birds, mammals, surface waters and aquatic organisms. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate.

                           The Member States concerned shall request the submission of further studies on rotational crops metabolism and to confirm the risk assessment for metabolite B12 and for aquatic organisms. They shall ensure that the notifiers at whose request benfluralin has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.

                     195

                     Fluazinam
                     CAS No 79622-59-6
                     CIPAC No 521

                     3-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-2, 6-dinitro-p-toluidine

                     ≥ 960 g/kg
                     Impurities:
                     5-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-4,6-dinitro-o-toluidine

                                 —

                                 not more than 2 g/kg

                     1 March 2009

                     28 February 2019

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing fluazinam for uses other than potatoes, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fluazinam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the protection of the operators' and workers' safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

                                 —

                                 the residues in food of plant and animal origin and evaluate the dietary exposure of consumers,

                                 —

                                 the protection of aquatic organisms. In relation to this identified risk, risk mitigation measures, such as buffer zones, should be applied where appropriate.

                           The Member States concerned shall request the submission of further studies to confirm the risk assessment for aquatic organisms and soil macro-organisms. They shall ensure that the notifiers at whose request fluazinam has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.

                     196

                     Fuberidazole
                     CAS No 3878-19-1
                     CIPAC No 525

                     2-(2′-furyl)benzimidazole

                     ≥ 970 g/kg

                     1 March 2009

                     28 February 2019

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing fuberidazole for uses other than seed dressing, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fuberidazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

                                 —

                                 long-term risk to mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. In such case the use of adequate equipment ensuring a high degree of incorporation in soil and a minimisation of spillage during application should apply.

                           Conditions of use shall include adequate risk mitigation measures, where appropriate.

                     197

                     Mepiquat
                     CAS No 15302-91-7
                     CIPAC No 440

                     1,1-dimethylpiperidinium chloride (mepiquat chloride)

                     ≥ 990 g/kg

                     1 March 2009

                     28 February 2019

                     PART A
                     Only uses as plant growth regulator may be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing mepiquat for uses other than in barley, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on mepiquat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.
                     The Member States must pay particular attention to the residues in food of plant and animal origin and evaluate the dietary exposure of consumers.’

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


Avis juridique important

|

32003L0119

Commission Directive 2003/119/EC of 5 December 2003 amending Council Directive 91/414/EEC to include mesosulfuron, propoxycarbazone and zoxamide as active substances (Text with EEA relevance)

Official Journal L 325 , 12/12/2003 P. 0041 - 0043

Commission Directive 2003/119/ECof 5 December 2003amending Council Directive 91/414/EEC to include mesosulfuron, propoxycarbazone and zoxamide 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 2003/84/EC(2), and in particular Article 6(1) thereof,Whereas:(1) In accordance with Article 6(2) of Directive 91/414/EEC, the authorities of France received on 15 December 2000 an application from Aventis Cropscience France (now Bayer CropScience) for the inclusion of the active substance mesosulfuron (in the form of mesosulfuron methyl) in Annex I to Directive 91/414/EEC. Commission Decision 2001/287/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) Germany received an application under Article 6(2) of Directive 91/414/EEC on 25 January 2000, an application from Bayer AG (now Bayer CropScience) concerning propoxycarbazone (in the form of propoxycarbazone sodium; former name: MKH 65 61). This application was declared complete by Commission Decision 2000/463/EC(4).(3) The United Kingdom received an application under Article 6(2) of Directive 91/414/EEC on 2 June 1999 from Rohm and Haas France SA (now: Dow AgroSciences) concerning zoxamide (former name: RH-7281). This application was declared complete by Commission Decision 2000/540/EC(5).(4) 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 draft assessment reports concerning the substances to the Commission on 12 December 2001 (mesosulfuron), 26 March 2001 (propoxycarbazone) and 10 August 2001 (zoxamide).(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 review was finalised on 3 October 2003 in the format of the Commission review report for mesosulfuron, propoxycarbazone and zoxamide.(6) The review of mesosulfuron, propoxycarbazone and zoxamide did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants.(7) 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 mesosulfuron, propoxycarbazone and zoxamide 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.(8) 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 mesosulfuron, propoxycarbazone and zoxamide 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.(9) It is therefore appropriate to amend Directive 91/414/EEC accordingly.(10) 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 21. Member States shall adopt and publish by 30 September 2004 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 October 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.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 31. Member States shall review the authorisation for each plant protection product containing mesosulfuron, propoxycarbazone or zoxamide 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 30 September 2004 at the latest.2. For each authorised plant protection product containing mesosulfuron, propoxycarbazone or zoxamide as the only active substance, 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 August 2005 at the latest, they shall amend or withdraw the authorisation for each such plant protection product.3. For each plant protection product containing mesosulfuron, propoxycarbazone or zoxamide together with one or more active substances which are all listed in Annex I to Directive 91/414/EEC, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to that Directive, 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, they shall amend or withdraw the authorisation for each such plant protection product, by the deadline defined for such an amendment or withdrawal in the respective Directives which amended Annex I so as to add the relevant substances to it. Where the respective Directives set different deadlines, the deadline shall be the latest of the dates defined.Article 4This Directive shall enter into force on 1 April 2004.Article 5This Directive is addressed to the Member States.Done at Brussels, 5 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 99, 10.4.2001, p. 9.(4) OJ L 183, 22.7.2000, p. 21.(5) OJ L 230, 12.9.2000, p. 14.ANNEXIn Annex I the following rows are added at the end of the table">TABLE>"


title: Commission Directive 2009/153/EC of 30 November 2009 amending Annex I to Council Directive 91/414/EEC as regards the common name and the purity of the active substance hydrolysed proteins (Text with EEA relevance)

text:
               1.12.2009

               EN

               Official Journal of the European Union

               L 314/67

      COMMISSION DIRECTIVE 2009/153/EC
   of 30 November 2009
   amending Annex I to Council Directive 91/414/EEC as regards the common name and the purity of the active substance hydrolysed proteins
   (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)

               Directive 91/414/EEC was amended by Commission Directive 2008/127/EC (2) to include certain hydrolysed proteins.

               (2)

               The rapporteur Member State has received additional information on hydrolysed proteins. It appears that hydrolysed proteins can be originated by many different organic compounds. It is therefore appropriate to refer to the common name and purity specifications, as set out in the review report on hydrolysed proteins.

               (3)

               Directive 91/414/EEC should therefore be amended accordingly.

               (4)

               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 28 February 2010 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 March 2010.
   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
   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 Brussels, 30 November 2009.

            For the Commission

         Androulla VASSILIOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 344, 20.12.2008, p. 89.

      ANNEX
      In Annex I to Directive 91/414/EEC, row No 240 is replaced by the following:

                     No

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘240

                     Hydrolysed proteins
                     CAS No: not allocated
                     CIPAC No: not allocated

                     Not available

                     Review report (SANCO/2615/2008)

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as attractant may be authorised. Hydrolysed proteins of animal origin must be in compliance with Regulation (EC) No 1774/2002.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on hydrolysed proteins (SANCO/2615/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.’

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


title: Commission Directive 2005/53/EC of 16 September 2005 amending Council Directive 91/414/EEC to include chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl as active substances   (Text with EEA relevance)

text:
               17.9.2005

               EN

               Official Journal of the European Union

               L 241/51

      COMMISSION DIRECTIVE 2005/53/EC
   of 16 September 2005
   amending Council Directive 91/414/EEC to include chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl 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), 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 chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl.

               (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 (3), 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. For chlorothalonil the rapporteur Member State was the Netherlands, and all relevant information was submitted on 31 January 2000. For chlorotoluron, the rapporteur Member State was Spain and all relevant information was submitted on 7 May 1999. For cypermethrin the rapporteur Member State was Belgium and all relevant information was submitted on 25 October 1999. For daminozide the rapporteur Member State was the Netherlands and all relevant information was submitted on 30 July 1999. For thiophanate-methyl, the rapporteur Member State was Germany and all relevant information was submitted on 21 November 1997.

               (3)

               The 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 February 2005 in the format of the Commission review reports for chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl.

               (5)

               The review of chlorothalonil, chlorotoluron and cypermethrin did not reveal any open questions to be addressed by the Scientific Committee on Plants or the European Food Safety Authority (EFSA) which has taken over the role of the latter.

               (6)

               The review of daminozide revealed a number of open questions which were addressed by the EFSA. The Scientific Panel on Plant Health, Plant Protection Products and their Residues (PPR Panel) of the EFSA was asked to comment on the mechanism of action of the carcinogenic response of rodents to 1,1-dimethylhydrazide (UDMH) and to indicate whether or not a threshold could be derived for this effect. If yes, it was requested to indicate this value. The PPR Panel, having regard to the submitted questions, concluded (4) that, on the basis of the available data, it is not possible to identify the mechanism responsible for the carcinogenic action of UDMH in rodents. There is no in vitro evidence of genotoxicity of pure and oxidation-protected UDMH and in vivo studies are not available. In addition, the PPR Panel noted an apparent discrepancy in that daminozide long-term studies did not give rise to carcinogenicity in rats and mice at doses that should have produced internal doses of metabolically-formed UDMH at least one order of magnitude higher than those proven to be effective on direct testing. In addition, methylation of N7 guanine was found to be 50-fold higher in one study following oral administration of UDMH to rats, when compared to the corresponding data for daminozide. Thus, the PPR Panel considered that any conclusion on the mechanism of carcinogenicity of orally administered UDMH should be regarded to include a degree of uncertainty. The PPR Panel concluded that the weight of evidence is against a genotoxic mechanism.
               Among possible non-genotoxic mechanisms, altered regulation of cell proliferation or hormonal imbalance are plausible alternatives to genotoxicity, but these mechanisms have not been specifically investigated and thus a more definitive conclusion on the mechanism involved is not possible at the moment. In experimental testing of UDMH for carcinogenicity in rats and mice, no effects were observed at 0,09 mg/kg bw/day and 1,41 mg/kg bw/day, respectively.
               If the observed UDMH carcinogenicity is due to a non-genotoxic mechanism, the above indicated doses should be considered to be toxicological thresholds. However, taking together the uncertainties associated with the mechanism and the possibility that UDMH in greenhouse conditions may form oxidised derivatives that might be genotoxic, the PPR Panel is of the opinion that any use of these doses as thresholds should be undertaken only with due caution. The opinion was taken into consideration by the Standing Committee that concluded that the use of daminozide is acceptable under the specified conditions.

               (7)

               The review of thiophanate-methyl revealed a number of open questions which were addressed by the Scientific Committee on Plants. The Scientific Committee was asked to comment on the advisability of establishing an acceptable daily intake (ADI) and acceptable operator exposure level (AOEL) having regard particularly to the results of mutagenicity, carcinogenicity and reproductive studies for benomyl, carbendazim and thiophanate-methyl. The Committee (5) noted that carbendazim is the biologically active substance common to these three substances. Benomyl in particular, but also thiophanate-methyl, is metabolised to carbendazim and all three substances produce numerical chromosomal aberrations (aneuploidy) in mammalian cells, exposed in vivo. There is no evidence that any other form of damage to genetic material is induced by any of these substances. Carcinogenicity is not a concern. The known effects of these fungicides upon reproduction are explicable by interaction with the microtubules of the spindle apparatus. The mechanism of aneuploidy induction is well understood and consists of inhibition of polymerisation of tubulin, the protein that is essential for the segregation of chromosomes during cell division: it does not involve any interaction with DNA. Since multiple copies of tubulin molecules are present in proliferating cells, in the presence of low concentration of the fungicides a limited number of tubulin molecules will be affected and consequently no toxicological adverse effects will ensue. Consequently, a clear no adverse effect level is recognisable and both an ADI and an AOEL can be established.

               (8)

               It has appeared from the various examinations made that plant protection products containing chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl 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 this active substance 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.

               (9)

               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.

               (10)

               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 chlorothalonil, chlorotoluron, cypermethrin, daminozide or thiophanate-methyl 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.

               (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)

               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 as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 31 August 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 1 September 2006.
   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 chlorothalonil, chlorotoluron, cypermethrin, daminozide or thiophanate-methyl as active substances by 31 August 2006.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl are met, with the exception of those identified in part B of the entries concerning those active substances, 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 derogation from paragraph 1, for each authorised plant protection product containing chlorothalonil, chlorotoluron, cypermethrin, daminozide or thiophanate-methyl 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 28 February 2006 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entries in Annex I to that Directive concerning chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing chlorothalonil, chlorotoluron, cypermethrin, daminozide or thiophanate-methyl as the only active substance, where necessary, amend or withdraw the authorisation by 28 February 2010 at the latest; or

               (b)

               in the case of a product containing chlorothalonil, chlorotoluron, cypermethrin, daminozide or thiophanate-methyl as one of several active substances, where necessary, amend or withdraw the authorisation by 28 February 2010 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 March 2006.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 16 September 2005.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Regulation (EC) No 396/2005 of the European Parliament and of the Council (OJ L 70, 16.3.2005, p. 1).

      (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. 27).

      (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).

      (4)  Opinion of the Scientific Panel on Plant Health, Plant Protection Products and their Residues on a request from the Commission related to the evaluation of daminozide in the context of Council Directive 91/414/EEC (The EFSA Journal (2004), 61, 1-27), adopted on 11 May 2004.

      (5)  Opinion of the Scientific Committee on Plants (SCP/BENOMY/002 — final, SCP/CARBEN/002 — final, SCP/THIOPHAN/002 — final) of 23 March 2001 regarding the evaluation of benomyl, carbendazim and thiophanate-methyl in the context of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Opinion adopted by the Scientific Committee on Plants on 7 March 2001).

      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

                     ‘102

                     Chlorothalonil
                     CAS No 1897-45-6
                     CIPAC No 288

                     Tetrachloroisophthalonitrile

                     985 g/kg

                                 —

                                 Hexachlorobenzene: not more than 0,01 g/kg

                                 —

                                 Decachlorobiphenyl: not more than 0,03 g/kg

                     1 March 2006

                     28 February 2016

                     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 chlorothalonil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account
                     In this overall assessment Members States must pay particular attention to the protection of:

                                 —

                                 aquatic organisms,

                                 —

                                 groundwater, in particular with regards to the active substance and its metabolites R417888 and R611965 (SDS46851), when the substance is applied in regions with vulnerable soil and/or climate conditions

                           Conditions of use should include risk mitigation measures, where appropriate

                     103

                     Chlorotoluron (unstated stereochemistry)
                     CAS No 15545-48-9
                     CIPAC No 217

                     3-(3-chloro-p-tolyl)-1,1-dimethylurea

                     975 g/kg

                     1 March 2006

                     28 February 2016

                     PART A
                     Only uses as herbicide may be authorised
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on chlorotoluron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Conditions of authorisation should include risk mitigation measures, where appropriate

                     104

                     Cypermethrin
                     CAS No 52315-07-8
                     CIPAC No 332

                     (RS)-α-cyano-3 phenoxybenzyl-(1RS)-cis, trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate
                     (4 isomer pairs: cis-1, cis-2, trans-3, trans-4)

                     900 g/kg

                     1 March 2006

                     28 February 2016

                     PART A
                     Only uses as insecticide may be authorised
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment

                                 —

                                 Member States must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate,

                                 —

                                 Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate

                     105

                     Daminozide
                     CAS No 1596-84-5
                     CIPAC No 330

                     N-dimethylaminosuccinamic acid

                     990 g/kg
                     Impurities:

                                 —

                                 N-nitrosodimethylamine: not more than 2,0 mg/kg

                                 —

                                 1,1-dimethylhydrazide: not more than 30 mg/kg

                     1 March 2006

                     28 February 2016

                     PART A
                     Only uses as growth regulator in non-edible crops may be authorised
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on daminozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the safety of operators and workers after re-entry. Conditions of authorisation should include protective measures, where appropriate

                     106

                     Thiophanate-methyl (unstated stereochemistry)
                     CAS No 23564-05-8
                     CIPAC No 262

                     Dimethyl 4,4’-(o-phenylene)bis(3-thioallophanate)

                     950 g/kg

                     1 March 2006

                     28 February 2016

                     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 thiophanate-methyl , and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of aquatic organisms, earthworms and other soil macro-organisms. Conditions of authorisation should include risk mitigation measures, where appropriate’

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


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Commission Directive 91/31/EEC of 19 December 1990 adapting the technical definition of 'multilateral development banks' in Council Directive 89/647/EEC of 18 December 1989 on a solvency ratio for credit institutions

Official Journal L 017 , 23/01/1991 P. 0020 - 0020 Finnish special edition: Chapter 6 Volume 3 P. 0083  Swedish special edition: Chapter 6 Volume 3 P. 0083

COMMISSION DIRECTIVE  of 19 December 1990  adapting the technical definition of 'multilateral development banks' in Council Directive 89/647/EEC of 18 December 1989 on a solvency ratio for credit institutions  (91/31/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 89/647/EEC of 18 December 1989 on a solvency ratio for credit institutions (1), and in particular Article 9 thereof,  Whereas the Commission has submitted a proposal for a Council Decision on the conclusion of the Agreement establishing an European Bank for Reconstruction and Development (2);  Whereas the seventh indent of Article 2 (1) of Directive 89/647/EEC defines the 'multilateral development banks' in a enumerate manner including the International Bank for Reconstruction and Development, the international Finance Corporation, the  Inter-American Development Bank, the Asian Development Bank, the African Development Bank, the Council of Europe Resettlement Fund, the Nordic Investment Bank and the Caribbean Development Bank;  Whereas the definition of multilateral development banks can be subject to technical adaptations as provided for in Article 9 (1) and in accordance with the procedure laid down in Article 9 (2) of Directive 89/647/EEC;  Whereas the European Bank for Reconstruction and Development embodies the same main characteristics as the abovementioned multilateral development banks; whereas this new multilateral financial institution is European in its basic character and broadly  international in its membership; whereas it constitutes a new and unique structure of cooperation in Europe in order to promote the economic progress of Central and Eastern European countries to help their economies become more internationally  competitive and assist them in their reconstruction and development, and thus to reduce, where appropriate, any risk related to the financing of their economies; whereas for these reasons the European Bank for Reconstruction and Development should be  included in the definition of 'multilateral development banks' in Council Directive 89/647/EEC;  Whereas the provisions of this Directive are in accordance with the opinion of the Banking Advisory Committee acting as the committee which is to assist the Commission in accordance with the procedure laid down in Article 9 (2) of Directive 89/647/EEC,   HAS ADOPTED THIS REGULATION:    Article 1  The definition of 'multilateral development banks' in the seventh indent of Article 2 (1) of Directive 89/647/EEC shall include the European Bank for Reconstruction and Development.  Article 2  1. Under the condition that the Council Decision on the conclusion of the Agreement establishing an European Bank for Reconstruction and Development has been adopted, Member States in implementing Directive 89/647/EEC shall adopt the measures  necessary for them to comply with the provision of this Directive by 31 March 1991 at the latest.  2. The Member States shall communicate to the Commission the texts of the main laws, regulations and administrative provisions which they adopt in the field covered by this Directive.  Article 3  This Directive is addressed to the Member States.   Done at Brussels, 19 December 1990. For the Commission  Leon BRITTAN  Vice-President   (1) OJ No L 386, 30. 12. 1989, p. 14. (2) OJ No C 241, 26. 9. 1990, p. 1.


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32001L0021

Commission Directive 2001/21/EC of 5 March 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include amitrole, diquat, pyridate and thiabendazole as active substances

Official Journal L 069 , 10/03/2001 P. 0017 - 0021

Commission Directive 2001/21/ECof 5 March 2001amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include amitrole, diquat, pyridate and thiabendazole 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 2000/80/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 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 State for the implementation of 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 amitrole, diquat, pyridate and thiabendazole 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 respective notifiers. Under Regulation (EC) No 933/94, France was designated as rapporteur Member State for amitrole, the United Kingdom for diquat, and Spain for thiabendazole. Austria was designated as rapporteur Member State for pyridate under 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. The rapporteur Member States submitted the relevant assessment report and recommendation to the Commission on 30 April 1996 (amitrole), on 2 April 1996 (diquat), on 18 November 1996 (pyridate) and 30 April 1996 (thiabendazole) in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92.(4) 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 12 December 2000 in the format of the respective Commission review reports for amitrole, diquat, pyridate and thiabendazole. If the review reports have to be updated to take account of technical and scientific developments, the conditions for the inclusion of the substances concerned 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 of amitrole were submitted to the Scientific Committee for Plants for consultation. In its opinion of 6 June 2000(8), the Committee confirmed the acceptable operator exposure level selected and offered advice on the interpretation of the long-term studies in rodents. The recommendations were taken into consideration in this Directive and in the relevant review report.(6) The dossier and the information from the review of diquat were also submitted to the Scientific Committee for Plants for consultation. In its opinion of 5 April 2000(9), the Committee offered advice on the interpretation of the available studies on bird reproduction, on potential long-term effects of residues bound to soil particles, on the potential environmental impact of aquatic weed control, and on certain aspects of operator and consumer exposure. The Committee offered its interpretation of the bird reproduction studies available. It concluded that there are no indications that residues in soil will have unacceptable effects. Further, the Committee noted that aquatic weed control uses of diquat may pose a high risk to non-target aquatic organisms and insufficient data is available to demonstrate that efficient risk mitigation measures can be applied. With regard to operator exposure, the Committee advised that measures should be considered to limit exposure of non-professional users. Finally, the Committee noted that insufficient information is available to fully assess the dietary exposure of consumers related to uses as desiccant in small grain cereals. Those opinions were taken into consideration in this Directive and in the relevant review report.(7) For pyridate also, the dossier and the information from the review were submitted to the Scientific Committee for Plants for consultation. In its opinion of 6 June 2000(10), the Committee confirmed the validity of the acceptable operator exposure level selected within the Standing Committee on Plant Health.(8) For thiabendazole as well, the dossier and the information from the review were submitted to the Scientific Committee for Plants for consultation. In its opinion of 22 September 2000(11), the Committee confirmed that the intended post-harvest uses of thiabendazole for fruit and potatoes will not pose an unacceptable risk to aquatic organisms, provided that adequate risk mitigation measures are applied. This recommendation was taken into consideration in this Directive and in the relevant review report.(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) 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.(10) Article 5(5) of the Directive provides that the inclusion of an active substance in Annex I can be reviewed at any time if there are indications that the criteria for inclusion are no longer satisfied. Therefore, the Commission will reconsider the inclusion in Annex I of amitrole if the requested additional information as outlined in point 7 of the review report were not submitted.(11) 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.(12) 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 amitrole, diquat, pyridate or thiabendazole. 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.(13) It is 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.(14) The review reports are 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 substances in Annex I to the Directive.(15) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health delivered on 12 December 2000,HAS ADOPTED THIS DIRECTIVE:Article 1Annex I to Directive 91/414/EEC is amended as set out in the Annex 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 amitrole, diquat, pyridate or thiabendazole as active substances 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 amitrole, diquat, pyridate or thiabendazole as the only active substance shall be 1 January 2006.3. For plant protection products containing amitrole, diquat, pyridate or thiabendazole 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 amitrole, diquat, pyridate and thiabendazole (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.5. Member States shall inform the Commission if the requested additional information outlined in point 7 of the Review Report for amitrole is not submitted by 1 January 2002. In such case the Commission will reconsider the inclusion of amitrole in Annex I to Directive 91/414/EEC.Article 3This Directive shall enter into force on 1 January, 2002.Article 4This Directive is addressed to the Member States.Done at Brussels, 5 March 2001.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1.(2) OJ L 309, 9.12.2000, p. 14.(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 SCP/AMITR/002 final.(9) Scientific Committee on Plants SCP/DIQUAT/002 final.(10) Scientific Committee on Plants SCP/PYRID/002 final.(11) Scientific Committee on Plants SCP/THIABEN/002-final.ANNEXThe following entries (numbered 14 to 17) shall be added at the end of the table in Annex I to Directive 91/414/EC: ">TABLE>"


title: Council Directive 2006/109/EC of 20 November 2006 adapting Directive 94/45/EC on the establishment of a European Works Council or a procedure in Community-scale undertakings and Community-scale groups of undertakings for the purposes of informing and consulting employees, by reason of the accession of Bulgaria and Romania

text:
               20.12.2006

               EN

               Official Journal of the European Union

               L 363/416

      COUNCIL DIRECTIVE 2006/109/EC
   of 20 November 2006
   adapting Directive 94/45/EC on the establishment of a European Works Council or a procedure in Community-scale undertakings and Community-scale groups of undertakings for the purposes of informing and consulting employees, by reason of the accession of Bulgaria and Romania
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community,
   Having regard to the Treaty of Accession of Bulgaria and Romania (1), and in particular Article 4(3) thereof,
   Having regard to the Act of Accession of Bulgaria and Romania, and in particular Article 56 thereof,
   Having regard to the proposal from the Commission,
   Whereas:

               (1)

               Pursuant to Article 56 of the Act of Accession, where acts of the institutions remain valid beyond 1 January 2007, and require adaptation by reason of accession, and the necessary adaptations have not been provided for in the Act of Accession or its Annexes, the necessary acts are to be adopted by the Council, unless the Commission adopted the original act.

               (2)

               The Final Act of the Conference which drew up the Treaty of Accession indicated that the High Contracting Parties had reached political agreement on a set of adaptations to acts adopted by the institutions required by reason of accession and invited the Council and the Commission to adopt these adaptations before accession, completed and updated where necessary to take account of the evolution of the law of the Union.

               (3)

               Council Directive 94/45/EC of 22 September 1994 on the establishment of a European Works Council or a procedure in Community-scale undertakings and Community-scale groups of undertakings for the purposes of informing and consulting employees (2) should therefore be amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 94/45/EC shall be amended as set out in the Annex.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by the date of accession of Bulgaria and Romania to the European Union at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, 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 Member States.
   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 subject to and on the date of the entry into force of the Treaty of Accession of Bulgaria and Romania.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 20 November 2006

            For the Council

            The President

         J. KORKEAOJA

      (1)  OJ L 157, 21.6.2005, p. 11.

      (2)  OJ L 254, 30.9.1994, p. 64.

      ANNEX
      SOCIAL POLICY AND EMPLOYMENT
      31994 L 0045: Council Directive 94/45/EC of 22 September 1994 on the establishment of a European Works Council or a procedure in Community-scale undertakings and Community-scale groups of undertakings for the purposes of informing and consulting employees (OJ L 254, 30.9.1994, p. 64), as amended by:

                  —

                  31997 L 0074: Council Directive 97/74/EC of 15.12.1997 (OJ L 10, 16.1.1998, p. 22).

            Without prejudice to any future review prior to the date of accession, Article 5(2)(b) is replaced by the following:

                     ‘(b)

                     The special negotiating body shall have a minimum of three members and a maximum of members equal to the number of Member States.’.


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32000L0067

Commission Directive 2000/67/EC of 23 October 2000 including an active substance (esfenvalerate) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market

Official Journal L 276 , 28/10/2000 P. 0038 - 0040

Commission Directive 2000/67/ECof 23 October 2000including an active substance (esfenvalerate) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the marketTHE 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 2000/10/EC(2), and in particular Article 6(1) and the fourth subparagraph of Article 8(2) thereof,Whereas:(1) Commission Regulation (EEC) No 3600/92(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(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 if it may be expected that neither the use of, nor residues from, plant protection products containing that active substance will have any harmful effects on human or animal health or on groundwatr or any unacceptable influence on the environment.(3) Such an active substance may be included in Annex I for a period not exceeding 10 years.(4) For esfenvalerate 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. Portugal was designated as rapporteur Member State under Regulation (EC) No 933/94 laying down the active substance of plant protection products and designating the rapporteur Member State for the implementation of Regulation (EEC) No 3600/92. It submitted the relevant assessment report to the Commission on 11 October 1996, in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92.(5) The assessment report has been reviewed by the Member States and the Commission within the Standing Committee on Plant Health. This review was finalised on 13 July 2000 in the format of the Commission review report for esfenvalerate.(6) The dossier and the information from the review have also been submitted to the Scientific Committee for Plants for consultation. The Scientific Committee for Plants in its opinion(7) noted that Member States must apply appropriate risk mitigation measures to protect the aquatic environment and non-target arthropods.(7) It has appeared from the assessments made that plant protection products containing the active substance concerned may be expected to satisfy in general the requirements laid down in Article 5(1)(a) and (b) of the Directive, in particular with regard to the uses which were examined. It is appropriate therefore to include the active substance concerned in Annex I, in order to ensure that in all Member States the granting, varying or withdrawing, as appropriate, of the authorisations of plant protection products containing esfenvalerate can be undertaken in accordance with the provisions of the Directive.(8) Article 8(2) of the Directive provides that after inclusion of an active substance in its Annex I, Member States shall, within a prescribed period, grant, vary or withdraw, as appropriate, the authorisations of the plant protection products containing the active substance. In particular, Articles 4(1) and 13(1) of the Directive require that plant protection products are not 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 Annex VI on the basis of a dossier satisfying the data requirements laid down in its Article 13.(9) Before inclusion, a reasonable deadline is necessary 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 for the Member States to implement the Directive and in particular to vary or withdraw, as appropriate, existing authorisations or grant new authorisations in accordance with the provisions of Directive 91/414/EEC. A longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product in accordance with the uniform principles laid down in Annex VI to the Directive. 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.(10) It is appropriate to provide that the finalised review report (except for confidential information in the meaning of Article 14 of the Directive) is kept available or made available by the Member States for consultation by any interested parties.(11) The review report is required for the proper implementation by the Member States of several sections of the uniform principles laid down in Annex VI to the Directive, where these principles refer to the evaluation of the Annex II data which were submitted for the purpose of the inclusion of the active substance in Annex I to the Directive.(12) 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 1Esfenvalerate is hereby designated as an active substance in Annex I to Directive 91/414/EEC, 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 January 2002 and shall immediately inform the Commission thereof. In particular they shall, in accordance with the provisions of Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing esfenvalerate as an active substance within such period.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 plant protection products containing esfenvalerate as the only active substance, to four years from the entry into force of this Directive,- for plant protection products containing esfenvalerate together with another active substance which is in Annex I to Directive 91/414/EEC, to four years from the entry into force of such Directive as shall include the last of those substances in Annex I.3. Member States shall keep available the review report (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.4. When Member States adopt the provisions referred to in paragraph 1, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.Article 3This Directive shall enter into force on 1 August 2001.Article 4This Directive is addressed to the Member States.Done at Brussels, 23 October 2000.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1.(2) OJ L 57, 2.3.2000, p. 28.(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) Scientific Committee on Plants SCP/ESFEN/002 final. 6 April 2000.ANNEXEsfenvalerate1.>TABLE>2. Particular conditions to be fulfilled:2.1. The active substance as manufactured shall have a minimum purity of 830 g/kg.2.2. Only uses as insecticide may be authorised.2.3. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on esfenvalerate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 13 July 2000 shall be taken into account. In this overall assessment Member States:must pay particular attention to the potential impact on aquatic organisms and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.3. Expiry date of the inclusion: 31 July 2011.