title: Commission Implementing Regulation (EU) No 806/2011 of 10 August 2011 approving the active substance fluquinconazole, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and Commission Decision 2008/934/EC  Text with EEA relevance

text:
               11.8.2011

               EN

               Official Journal of the European Union

               L 206/39

         COMMISSION IMPLEMENTING REGULATION (EU) No 806/2011
   of 10 August 2011
   approving the active substance fluquinconazole, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and Commission Decision 2008/934/EC
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) and Article 78(2) thereof,
   Whereas:

               (1)

               In accordance with Article 80(1)(c) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply to active substances for which completeness has been established in accordance with Article 16 of Commission Regulation (EC) No 33/2008 (3), with respect to the procedure and the conditions for approval. Fluquinconazole is an active substance for which completeness has been established in accordance with that Regulation.

               (2)

               Commission Regulations (EC) No 451/2000 (4) and (EC) No 1490/2002 (5) lay down the detailed rules for the implementation of the second and third stages 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 included fluquinconazole.

               (3)

               In accordance with Article 3(2) of Commission Regulation (EC) No 1095/2007 of 20 September 2007 amending Regulation (EC) No 1490/2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC and Regulation (EC) No 2229/2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (6) the notifier withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within 2 months from entry into force of that Regulation. Consequently, Commission Decision 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances (7) was adopted on the non-inclusion of fluquinconazole.

               (4)

               Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Regulation (EC) No 33/2008 laying down detailed rules for the application of Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I.

               (5)

               The application was submitted to Ireland, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/934/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

               (6)

               Ireland evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 13 April 2010. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on fluquinconazole to the Commission on 25 February 2011 (8). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 17 June 2011 in the format of the Commission review report for fluquinconazole.

               (7)

               It has appeared from the various examinations made that plant protection products containing fluquinconazole 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 as regards the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve fluquinconazole in accordance with Regulation (EC) No 1107/2009.

               (8)

               In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions.

               (9)

               Without prejudice to the conclusion that fluquinconazole should be approved, it is, in particular, appropriate to require further confirmatory information.

               (10)

               A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

               (11)

               Without prejudice to the obligations defined by Regulation (EC) No 1107/2009 as a consequence of the approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009 the following should, however, apply. Member States should be allowed a period of 6 months after approval to review authorisations of plant protection products containing fluquinconazole. Member States should, as appropriate, vary, replace or withdraw existing authorisations. By way of derogation from the above deadline, a longer period should be provided for the submission and assessment of the update of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

               (12)

               The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of 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 (9) 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 to that Directive or the Regulations approving active substances.

               (13)

               In accordance with Article 13(4) of Regulation (EC) No 1107/2009 the Annex to Commission Implementing Regulation (EU) No 540/2011 (10) should be amended accordingly.

               (14)

               Decision 2008/934/EC provides for the non-inclusion of fluquinconazole and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning fluquinconazole in the Annex to that Decision. It is therefore appropriate to amend Decision 2008/934/EC accordingly.

               (15)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of active substance
   The active substance fluquinconazole, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
   Article 2
   Re-evaluation of plant protection products
   1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing fluquinconazole as an active substance by 30 June 2012.
   By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in Part B of the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing fluquinconazole as either the only active substance or as one of several active substances all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 December 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account Part B of the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009. Following that determination Member States shall:

               (a)

               in the case of a product containing fluquinconazole as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or

               (b)

               in the case of a product containing fluquinconazole as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or substances, whichever is the latest.

         Article 3
   Amendments to Implementing Regulation (EU) No 540/2011
   The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
   Article 4
   Amendments to Decision 2008/934/EC
   The line concerning fluquinconazole in the Annex to Decision 2008/934/EC is deleted.
   Article 5
   Entry into force and date of application
   This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   It shall apply from 1 January 2012.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 10 August 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  OJ L 230, 19.8.1991, p. 1.

      (3)  OJ L 15, 18.1.2008, p. 5.

      (4)  OJ L 55, 29.2.2000, p. 25.

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

      (6)  OJ L 246, 21.9.2007, p. 19.

      (7)  OJ L 333, 11.12.2008, p. 11.

      (8)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance fluquinconazole. EFSA Journal 2011;9(5):2096. [112 pp.]. doi:10.2903/j.efsa.2011.2096. Available online: www.efsa.europa.eu

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

      (10)  OJ L 153, 11.6.2011, p. 1.

      ANNEX I

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  Fluquinconazole
                  CAS No 136426-54-5
                  CIPAC No 474

                  3-(2,4-dichlorophenyl)-6-fluoro-2-(1H-1,2,4-triazol-1-yl)quinazolin-4(3H)-one

                  ≥ 955 g/kg

                  1 January 2012

                  31 December 2021

                  PART A
                  Only uses as fungicide may be authorised
                  PART B
                  For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluquinconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.
                  In this overall assessment Member States:

                              (a)

                              shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;

                              (b)

                              shall pay particular attention to the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs);

                              (c)

                              shall pay particular attention to the risk to birds and mammals.

                        Conditions of use shall include risk mitigation measures, where appropriate.
                  The applicant shall submit confirmatory information as regards:

                              (1)

                              residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;

                              (2)

                              the contribution of the potential residues of the metabolite dione in rotational crops to the overall consumer exposure;

                              (3)

                              the acute risk to insectivorous mammals;

                              (4)

                              the long-term risk to insectivorous and herbivorous birds and mammals;

                              (5)

                              the risk to earthworm-eating mammals;

                              (6)

                              the endocrine disruption potential in aquatic organisms (fish full life cycle study).

                        The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.

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

      ANNEX II
      In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

                     Number

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘14

                     Fluquinconazole
                     CAS No 136426-54-5
                     CIPAC No 474

                     3-(2,4-dichlorophenyl)-6-fluoro-2-(1H-1,2,4-triazol-1-yl)quinazolin-4(3H)-one

                     ≥ 955 g/kg

                     1 January 2012

                     31 December 2021

                     PART A
                     Only uses as fungicide may be authorised
                     PART B
                     For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluquinconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.
                     In this overall assessment Member States:

                                 (a)

                                 shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;

                                 (b)

                                 shall pay particular attention to the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs);

                                 (c)

                                 shall pay particular attention to the risk to birds and mammals.

                           Conditions of use shall include risk mitigation measures, where appropriate.
                     The applicant shall submit confirmatory information as regards:

                                 (1)

                                 residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;

                                 (2)

                                 the contribution of the potential residues of the metabolite dione in rotational crops to the overall consumer exposure;

                                 (3)

                                 the acute risk to insectivorous mammals;

                                 (4)

                                 the long-term risk to insectivorous and herbivorous birds and mammals;

                                 (5)

                                 the risk to earthworm-eating mammals;

                                 (6)

                                 the endocrine disruption potential in aquatic organisms (fish full life cycle study).

                           The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.’

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


title: Commission Implementing Regulation (EU) No 546/2013 of 14 June 2013 approving the active substance eugenol, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011  Text with EEA relevance

text:
               15.6.2013

               EN

               Official Journal of the European Union

               L 163/17

         COMMISSION IMPLEMENTING REGULATION (EU) No 546/2013
   of 14 June 2013
   approving the active substance eugenol, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) and Article 78(2) thereof,
   Whereas:

               (1)

               In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For eugenol the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Implementing Decision 2011/266/EU (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 7 March 2008 an application from Eden Research PLC for the inclusion of the active substance eugenol in Annex I to Directive 91/414/EEC. Implementing Decision 2011/266/EU 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.

               (3)

               For that active substance, the effects on human and animal 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 30 June 2011.

               (4)

               The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the review of the pesticide risk assessment of the active substance eugenol (4) on 15 October 2012. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and the draft assessment report was finalised on 17 May 2013 in the format of the Commission review report for eugenol.

               (5)

               It has appeared from the various examinations made that plant protection products containing eugenol 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 use which was examined and detailed in the Commission review report. It is therefore appropriate to approve eugenol.

               (6)

               In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.

               (7)

               A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

               (8)

               Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing eugenol. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the update of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

               (9)

               The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of 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 (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 to that Directive or the Regulations approving active substances.

               (10)

               In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (6) should be amended accordingly.

               (11)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of active substance
   The active substance eugenol, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
   Article 2
   Re-evaluation of plant protection products
   1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing eugenol as an active substance by 31 May 2014.
   By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing eugenol as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 30 November 2013 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
   Following that determination Member States shall:

               (a)

               in the case of a product containing eugenol as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or

               (b)

               in the case of a product containing eugenol as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

         Article 3
   Amendments to Implementing Regulation (EU) No 540/2011
   The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
   Article 4
   Entry into force and date of application
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 December 2013.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 14 June 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  OJ L 230, 19.8.1991, p. 1.

      (3)  OJ L 114, 4.5.2011, p. 3.

      (4)  EFSA Journal 2012; 10(11):2914. Available online: www.efsa.europa.eu

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

      (6)  OJ L 153, 11.6.2011, p. 1.

      ANNEX I

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  Eugenol CAS No 97-53-0
                  CIPAC No 967

                  4-allyl-2-methoxyphenol

                  ≥ 990 g/kg
                  Relevant impurity: methyl eugenol maximum 0,1 % of the technical material

                  1 December 2013

                  30 November 2023

                  For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on eugenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              —

                              the protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate,

                              —

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

                              —

                              the risk to aquatic organisms,

                              —

                              the risk to insectivorous birds.

                        Conditions of use shall include risk mitigation measures, where appropriate.
                  The applicant shall submit confirmatory information as regards:

                              (a)

                              the storage stability (2 years) at ambient temperature on the formulated product;

                              (b)

                              data comparing natural background exposure situations of eugenol and methyl eugenol in relation to exposure from the use of eugenol as a plant protection product. This data shall cover human exposure as well as exposure of birds and aquatic organisms;

                              (c)

                              the groundwater exposure assessment for potential metabolites of eugenol, in particular for methyl eugenol.

                        The applicant shall submit to the Commission, the Member States and the Authority that information by 30 November 2015.

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

      ANNEX II
      In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

                     Number

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘45

                     Eugenol CAS No 97-53-0
                     CIPAC No 967

                     4-allyl-2-methoxyphenol

                     ≥ 990 g/kg
                     Relevant impurity: methyl eugenol maximum 0,1 % of the technical material

                     1 December 2013

                     30 November 2023

                     For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on eugenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 —

                                 the protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate,

                                 —

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

                                 —

                                 the risk to aquatic organisms,

                                 —

                                 the risk to insectivorous birds.

                           Conditions of use shall include risk mitigation measures, where appropriate.
                     The applicant shall submit confirmatory information as regards:

                                 (a)

                                 the storage stability (2 years) at ambient temperature on the formulated product;

                                 (b)

                                 data comparing natural background exposure situations of eugenol and methyl eugenol in relation to exposure from the use of eugenol as a plant protection product. This data shall cover human exposure as well as exposure of birds and aquatic organisms;

                                 (c)

                                 the groundwater exposure assessment for potential metabolites of eugenol, in particular for methyl eugenol.

                           The applicant shall submit to the Commission, the Member States and the Authority that information by 30 November 2015.’

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


title: Commission Implementing Regulation (EU) No 1175/2013 of 20 November 2013 approving the active substance benalaxyl-M, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011  Text with EEA relevance

text:
               21.11.2013

               EN

               Official Journal of the European Union

               L 312/18

      COMMISSION IMPLEMENTING REGULATION (EU) No 1175/2013
   of 20 November 2013
   approving the active substance benalaxyl-M, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) and Article 78(2) thereof,
   Whereas:

               (1)

               In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For benalaxyl-M the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2003/35/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC Portugal received on 22 February 2002 an application from Isagro SpA for the inclusion of the active substance benalaxyl-M in Annex I to Directive 91/414/EEC. Decision 2003/35/EC 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.

               (3)

               For that active substance, the effects on human and animal 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 21 November 2003. This draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion (4) on the pesticide risk assessment of the active substance benalaxyl-M on 28 July 2007.

               (4)

               In its conclusion, the Authority did not take into account all information submitted by the applicant and assessed by the designated rapporteur Member State before that date. The Commission requested the Authority to revise its conclusion and to take into account all information submitted.

               (5)

               The designated rapporteur Member State assessed all information submitted by the applicant and submitted an Addendum to the draft assessment report on 16 April 2012.

               (6)

               The Addendum to the draft assessment report was reviewed by the Member States and the Authority. The Authority presented to the Commission a first version of its conclusion (5) on the pesticide risk assessment of the active substance benalaxyl-M on 21 March 2013 and an amended version on 25 March 2013. The updated draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 3 October 2013 in the format of the Commission review report for benalaxyl-M.

               (7)

               It has appeared from the various examinations made that plant protection products containing benalaxyl-M 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 approve benalaxyl-M.

               (8)

               A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

               (9)

               Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing benalaxyl-M. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

               (10)

               The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (6) 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 to that Directive or the Regulations approving active substances.

               (11)

               In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (7) should be amended accordingly.

               (12)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of active substance
   The active substance benalaxyl-M, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
   Article 2
   Re-evaluation of plant protection products
   1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing benalaxyl-M as an active substance by 31 October 2014.
   By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing benalaxyl-M as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 30 April 2014 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
   Following that determination Member States shall:

               (a)

               in the case of a product containing benalaxyl-M as the only active substance, where necessary, amend or withdraw the authorisation by 31 October 2015 at the latest; or

               (b)

               in the case of a product containing benalaxyl-M as one of several active substances, where necessary, amend or withdraw the authorisation by 31 October 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

         Article 3
   Amendments to Implementing Regulation (EU) No 540/2011
   The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
   Article 4
   Entry into force and date of application
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 May 2014.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 20 November 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

      (3)  Commission Decision 2003/35/EC of 10 January 2003 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of benalaxyl-M, benthiavalicarb, 1-methylcyclopropene, prothioconazole and fluoxastrobin in Annex I to Council Directive 91/414/EEC concerning the placing of plant-protection products on the market (OJ L 11, 16.1.2003, p. 52).

      (4)  EFSA Scientific Report (2007) 108, 1-86.

      (5)  EFSA Journal 2013; 11(1):3052. Available online: www.efsa.europa.eu

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

      (7)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

      ANNEX I

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  Benalaxyl-M
                  CAS No 98243-83-5
                  CIPAC No 766

                  Methyl N-(phenylacetyl)-N-(2,6-xylyl)-D-alaninate

                  ≥ 950 g/kg

                  1 May 2014

                  30 April 2024

                  For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on benalaxyl-M, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              —

                              the protection of workers at re-entry,

                              —

                              the risk to groundwater from the metabolites BM-M2 (N-(malonyl)-N-(2,6-xylyl)-DL-alanine) and BM-M3 (N-(malonyl)-N-(2,6-xylyl)-D-alanine), when the substance is applied in regions with vulnerable soil and/or climatic conditions.

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

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

      ANNEX II
      In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

                     Number

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘58

                     Benalaxyl-M
                     CAS No 98243-83-5
                     CIPAC No 766

                     Methyl N-(phenylacetyl)-N-(2,6-xylyl)-D-alaninate

                     ≥ 950 g/kg

                     1 May 2014

                     30 April 2024

                     For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on benalaxyl-M, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 —

                                 the protection of workers at re-entry,

                                 —

                                 the risk to groundwater from the metabolites BM-M2 (N-(malonyl)-N-(2,6-xylyl)-DL-alanine) and BM-M3 (N-(malonyl)-N-(2,6-xylyl)-D-alanine), when the substance is applied in regions with vulnerable soil and/or climatic conditions.

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

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


title: Commission Implementing Regulation (EU) No 1166/2013 of 18 November 2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance dichlorprop-P  Text with EEA relevance

text:
               19.11.2013

               EN

               Official Journal of the European Union

               L 309/22

         COMMISSION IMPLEMENTING REGULATION (EU) No 1166/2013
   of 18 November 2013
   amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance dichlorprop-P
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the second alternative of Article 21(3) and Article 78(2) thereof,
   Whereas:

               (1)

               Commission Directive 2006/74/EC (2) included dichlorprop-P as active substance in Annex I to Council Directive 91/414/EEC (3), under the condition that the Member States concerned ensure that the notifier at whose request dichlorprop-P was included in that Annex provide further confirmatory information on animal metabolism and the risk assessment on acute and short-term exposure for birds and on acute exposure for herbivorous mammals.

               (2)

               Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

               (3)

               The notifier submitted additional information with a view to confirm the risk assessment for birds and mammals for the use in cereals, grassland and grass seed crops to the rapporteur Member State Denmark within the time period provided for its submission.

               (4)

               Denmark assessed the additional information submitted by the notifier. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter ‘the Authority’, on 22 July 2011.

               (5)

               The Commission consulted the Authority which presented its opinion on the risk assessment of dichlorprop-P on 13 November 2012 (5).

               (6)

               In the light of the additional information provided by the notifier, the Commission considered that the further confirmatory information required had not fully been provided and that a high risk for birds and mammals could not be excluded except by imposing further restrictions.

               (7)

               The Commission invited the notifier to submit its comments on the review report for dichlorprop-P.

               (8)

               It is confirmed that the active substance dichlorprop-P is to be deemed to have been approved under Regulation (EC) No 1107/2009. In order to minimise the exposure of birds and mammals, it is, however, appropriate to further restrict the uses of this active substance and to provide for specific risk mitigation measures for the protection of those species.

               (9)

               The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

               (10)

               Member States should be provided with time to withdraw authorisations for plant protection products containing dichlorprop-P.

               (11)

               For plant protection products containing dichlorprop-P, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, this period should, at the latest, expire one year after the withdrawal or the amendment of the respective authorisations.

               (12)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Amendment to Implementing Regulation (EU) No 540/2011
   Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
   Article 2
   Transitional measures
   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary amend or withdraw existing authorisations for plant protection products containing dichlorprop-P as active substance by 9 June 2014.
   Article 3
   Period of grace
   Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire by 9 June 2015 at the latest.
   Article 4
   Entry into force
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 18 November 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  Commission Directive 2006/74/EC of 21 August 2006 amending Council Directive 91/414/EEC to include dichlorprop-P, metconazole, pyrimethanil and triclopyr as active substances (OJ L 235, 30.8.2006, p. 17).

      (3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

      (4)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

      (5)  EFSA Journal 2012;10(11):2950. Available online: www.efsa.europa.eu/efsajournal.htm

      ANNEX
      The column ‘Specific provisions’ of row 133, dichlorprop-P, of Part A of the Annex to Implementing Regulation (EU) No 540/2011 is replaced by the following:

         ‘PART A
         Only uses as herbicide may be authorised.
         As regards cereals, only application in spring may be authorised, at rates not exceeding 800 g active substance per hectare per application.
         Use on grassland shall not be authorised.
         PART B
         For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dichlorprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.
         In this overall assessment Member States shall pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants.
         Conditions of authorisation shall include risk mitigation measures, where appropriate.’


title: Commission Implementing Regulation (EU) No 533/2013 of 10 June 2013 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-methyl-cyclopropene, chlorothalonil, chlorotoluron, cypermethrin, daminozide, forchlorfenuron, indoxacarb, thiophanate-methyl and tribenuron  Text with EEA relevance

text:
               11.6.2013

               EN

               Official Journal of the European Union

               L 159/9

         COMMISSION IMPLEMENTING REGULATION (EU) No 533/2013
   of 10 June 2013
   amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-methyl-cyclopropene, chlorothalonil, chlorotoluron, cypermethrin, daminozide, forchlorfenuron, indoxacarb, thiophanate-methyl and tribenuron
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the first paragraph of Article 17 thereof,
   Whereas:

               (1)

               Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009.

               (2)

               The approvals of the active substances 1-methyl-cyclopropene, chlorothalonil, chlorotoluron, cypermethrin, daminozide, forchlorfenuron, indoxacarb, thiophanate-methyl and tribenuron will expire between 28 February 2016 and 31 March 2016. Applications have been submitted for the renewal of these active substances. As the requirements laid down in Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (3) apply to those active substances, it is necessary to allow applicants sufficient time to complete the renewal procedure in accordance with that Regulation. Consequently, the approvals of those active substances are likely to expire before a decision has been taken on their renewal. It is therefore necessary to extend their approval periods.

               (3)

               Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

               (4)

               In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where no supplementary dossier in accordance with Implementing Regulation (EU) No 844/2012 is submitted no later than 30 months before the respective expiry date laid down in the Annex to this Regulation, the Commission will set the expiry date at the same date as before the entry into force of this Regulation or at the earliest date thereafter.

               (5)

               In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where the Commission will adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission will set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later.

               (6)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 10 June 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  OJ L 153, 11.6.2011, p. 1.

      (3)  OJ L 252, 19.9.2012, p. 26.

      ANNEX
      Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

                  (1)

                  In the sixth column, expiration of approval, of row 101, chlorothalonil, the date 28 February 2016 is replaced by 31 October 2017.

                  (2)

                  In the sixth column, expiration of approval, of row 102, chlorotoluron, the date 28 February 2016 is replaced by 31 October 2017.

                  (3)

                  In the sixth column, expiration of approval, of row 103, cypermethrin, the date 28 February 2016 is replaced by 31 October 2017.

                  (4)

                  In the sixth column, expiration of approval, of row 104, daminozide, the date 28 February 2016 is replaced by 31 October 2017.

                  (5)

                  In the sixth column, expiration of approval, of row 105, thiophanate-methyl, the date 28 February 2016 is replaced by 31 October 2017.

                  (6)

                  In the sixth column, expiration of approval, of row 106, tribenuron, the date 28 February 2016 is replaced by 31 October 2017.

                  (7)

                  In the sixth column, expiration of approval, of row 117, 1-methyl-cyclopropene, the date 31 March 2016 is replaced by 31 October 2017.

                  (8)

                  In the sixth column, expiration of approval, of row 118, forchlorfenuron, the date 31 March 2016 is replaced by 31 October 2017.

                  (9)

                  In the sixth column, expiration of approval, of row 119, indoxacarb, the date 31 March 2016 is replaced by 31 October 2017.


title: Commission Implementing Regulation (EU) No 678/2014 of 19 June 2014 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances clopyralid, cyprodinil, fosetyl, pyrimethanil and trinexapac  Text with EEA relevance

text:
               20.6.2014

               EN

               Official Journal of the European Union

               L 180/11

         COMMISSION IMPLEMENTING REGULATION (EU) No 678/2014
   of 19 June 2014
   amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances clopyralid, cyprodinil, fosetyl, pyrimethanil and trinexapac
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the first paragraph of Article 17 thereof,
   Whereas:

               (1)

               Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009.

               (2)

               The approvals of the active substances clopyralid, cyprodinil, fosetyl and trinexapac will expire on 30 April 2017 and that of the active substance pyrimethanil will expire on 31 May 2017. Applications have been submitted for the renewal of the approval of those active substances. As the requirements laid down in Commission Implementing Regulation (EU) No 844/2012 (3) apply to those active substances, it is necessary to provide for sufficient time to complete the renewal procedure in accordance with that Regulation. Consequently, the approvals of those active substances are likely to expire before a decision has been taken on their renewal. It is therefore necessary to extend their approval periods.

               (3)

               Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

               (4)

               In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where no supplementary dossier in accordance with Implementing Regulation (EU) No 844/2012 is submitted no later than 30 months before the respective expiry date laid down in the Annex to this Regulation, the Commission will set the expiry date at the same date as before this Regulation or at the earliest date thereafter.

               (5)

               In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where the Commission will adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission will set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later.

               (6)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 19 June 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

      (3)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

      ANNEX
      Part A of the Annex to Regulation (EU) No 540/2011 is amended as follows:

                  (1)

                  In the sixth column, expiration of approval, of row 129, clopyralid, the date of ‘30 April 2017’ is replaced by ‘30 April 2018’;

                  (2)

                  In the sixth column, expiration of approval, of row 130, cyprodinil, the date of ‘30 April 2017’ is replaced by ‘30 April 2018’;

                  (3)

                  In the sixth column, expiration of approval, of row 131, fosetyl, the date of ‘30 April 2017’ is replaced by ‘30 April 2018’;

                  (4)

                  In the sixth column, expiration of approval, of row 132, trinexapac, the date of ‘30 April 2017’ is replaced by ‘30 April 2018’;

                  (5)

                  In the sixth column, expiration of approval, of row 135, pyrimethanil, the date of ‘31 May 2017’ is replaced by ‘30 April 2018’.


title: Commission Implementing Regulation (EU) No 541/2011 of 1 June 2011 amending Implementing Regulation (EU) No 540/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances  Text with EEA relevance

text:
               11.6.2011

               EN

               Official Journal of the European Union

               L 153/187

         COMMISSION IMPLEMENTING REGULATION (EU) No 541/2011
   of 1 June 2011
   amending Implementing Regulation (EU) No 540/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 78(2) thereof,
   Whereas:

               (1)

               It is appropriate to list active substances deemed to be approved under Regulation (EC) No 1107/2009 and active substances approved under that Regulation in separate Parts of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2).

               (2)

               Regulation (EU) No 540/2011 should therefore be amended accordingly.

               (3)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Regulation (EU) No 540/2011 is amended as follows:

               (1)

               Article 1 is replaced by the following:
               ‘Article 1
               The active substances, as set out in Part A of the Annex, shall be deemed to have been approved under Regulation (EC) No 1107/2009.
               The active substances approved under Regulation (EC) No 1107/2009 are as set out in Part B of the Annex.’

               (2)

               The Annex to Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

         Article 2
   This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
   It shall apply from 14 June 2011.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 1 June 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  See page 1 of this Official Journal.

      ANNEX
      The Annex to Regulation (EU) No 540/2011 is amended as follows:

                  (1)

                  In the title of the Annex the words ‘ACTIVE SUBSTANCES APPROVED FOR USE IN PLANT PROTECTION PRODUCTS’ are replaced by the following:

                  (2)

                  The words ‘General provisions applying to all substances listed in this Annex:’ are replaced by ‘General provisions applying to all substances listed in this Part:’

                  (3)

                  The following Part B is added:
                  ‘PART B

                     Active substances approved under Regulation (EC) No 1107/2009

                  General provisions applying to all substances listed in this Part:

                              —

                              for the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009 in relation to each substance, the conclusions of the review report on it, and in particular the Appendices I and II thereof, shall be taken into account;

                              —

                              Member States shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or shall make it available to them on specific request.

                              Number

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity (1)

                              Date of approval

                              Expiration of approval

                              Specific provisions

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


title: Commission Implementing Regulation (EU) No 832/2013 of 30 August 2013 approving the active substance disodium phosphonate, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011  Text with EEA relevance

text:
               31.8.2013

               EN

               Official Journal of the European Union

               L 233/3

         COMMISSION IMPLEMENTING REGULATION (EU) No 832/2013
   of 30 August 2013
   approving the active substance disodium phosphonate, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) and Article 78(2) thereof,
   Whereas:

               (1)

               In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For disodium phosphonate the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2008/953/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC France received on 11 February 2008 an application from ISK BioSciences Europe N.V. for the inclusion of the active substance disodium phosphonate in Annex I to Directive 91/414/EEC. Decision 2008/953/EC 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.

               (3)

               For that active substance, the effects on human and animal 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 27 August 2009.

               (4)

               The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter 'the Authority'). The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance disodium phosphonate (4) on 22 April 2013. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 16 July 2013 in the format of the Commission review report for disodium phosphonate.

               (5)

               It has appeared from the various examinations made that plant protection products containing disodium phosphonate 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 use which was examined and detailed in the Commission review report. It is therefore appropriate to approve disodium phosphonate.

               (6)

               In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.

               (7)

               A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

               (8)

               Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing disodium phosphonate. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

               (9)

               The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of 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 (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 to that Directive or the Regulations approving active substances.

               (10)

               In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (6) should be amended accordingly.

               (11)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of active substance
   The active substance disodium phosphonate, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
   Article 2
   Re-evaluation of plant protection products
   1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing disodium phosphonate as an active substance by 31 July 2014.
   By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing disodium phosphonate as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 January 2014 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
   Following that determination Member States shall:

               (a)

               in the case of a product containing disodium phosphonate as the only active substance, where necessary, amend or withdraw the authorisation by 31 July 2015 at the latest; or

               (b)

               in the case of a product containing disodium phosphonate as one of several active substances, where necessary, amend or withdraw the authorisation by 31 July 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

         Article 3
   Amendments to Implementing Regulation (EU) No 540/2011
   The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
   Article 4
   Entry into force and date of application
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 February 2014.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 30 August 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  OJ L 230, 19.8.1991, p. 1.

      (3)  OJ L 338, 17.12.2008, p. 62.

      (4)  EFSA Journal (2013) 11(5):3213. Available online: www.efsa.europa.eu.

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

      (6)  OJ L 153, 11.6.2011, p. 1.

      ANNEX I

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  Disodium phosphonate
                  CAS No 13708-85-5
                  CIPAC No 808

                  disodium phosphonate

                  281-337 g/kg (TK)
                  ≥ 917 g/kg (TC)

                  1 February 2014

                  31 January 2024

                  For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on disodium phosphonate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to the risk of eutrophication of surface water.
                  Conditions of use shall include risk mitigation measures, where appropriate.
                  The applicant shall submit confirmatory information as regards

                              (a)

                              the chronic risk to fish;

                              (b)

                              the long term risk to earthworms and soil macro-organisms.

                        The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016.

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

      ANNEX II
      In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

                     Number

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘54

                     Disodium phosphonate
                     CAS No 13708-85-5
                     CIPAC No 808

                     disodium phosphonate

                     281-337 g/kg (TK)
                     ≥ 917 g/kg (TC)

                     1 February 2014

                     31 January 2024

                     For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on disodium phosphonate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to the risk to eutrophication of surface water.
                     Conditions of use shall include risk mitigation measures, where appropriate.
                     The applicant shall submit confirmatory information as regards

                                 (a)

                                 the chronic risk to fish;

                                 (b)

                                 the long term risk to earthworms and soil macro-organisms.

                           The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016.’

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