title: Commission Implementing Regulation (EU) No 786/2011 of 5 August 2011 approving the active substance 1-naphthylacetamide, 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 2008/941/EC  Text with EEA relevance

text:
               6.8.2011

               EN

               Official Journal of the European Union

               L 203/11

         COMMISSION IMPLEMENTING REGULATION (EU) No 786/2011
   of 5 August 2011
   approving the active substance 1-naphthylacetamide, 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 2008/941/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 Articles 13(2) and 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. 1-Naphthylacetamide is an active substance for which completeness has been established in accordance with that Regulation.

               (2)

               Commission Regulations (EC) No 1112/2002 (4) and (EC) No 2229/2004 (5) lay down the detailed rules for the implementation of the fourth 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 included 1-naphthylacetamide.

               (3)

               In accordance with Article 24e of Regulation (EC) No 2229/2004 the notifier withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within 2 months from receipt of the draft assessment report referred to in Article 24(2) of that Regulation. Consequently, Commission Decision 2008/941/EC of 8 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 (6) was adopted on the non-inclusion of 1-naphthylacetamide.

               (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 Council 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 France, which had been designated rapporteur Member State by Regulation (EC) No 2229/2004. 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 2008/941/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

               (6)

               France 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 12 March 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 1-naphthylacetamide to the Commission on 15 February 2011 (7). 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 1-naphthylacetamide.

               (7)

               It has appeared from the various examinations made that plant protection products containing 1-naphthylacetamide 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 1-naphthylacetamide 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 1-naphthylacetamide 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 1-naphthylacetamide. 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 (8) 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 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 (9) should be amended accordingly.

               (14)

               Decision 2008/941/EC provides for the non-inclusion of 1-naphthylacetamide and the withdrawal of authorisations for plants protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning 1-naphthylacetamide in the Annex to that Decision. It is therefore appropriate to amend Decision 2008/941/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 1-naphthylacetamide, 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 1-naphthylacetamide 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 1-naphthylacetamide 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 1-naphthylacetamide 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 1-naphthylacetamide 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 2008/941/EC
   The line concerning 1-naphthylacetamide in the Annex to Decision 2008/941/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, 5 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 168, 27.6.2002, p. 14.

      (5)  OJ L 379, 24.12.2004, p. 13.

      (6)  OJ L 335, 13.12.2008, p. 91.

      (7)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance 2-(1-naphthyl)acetamide. EFSA Journal 2011;9(2):2020. [58 pp.]. doi:10.2903/j.efsa.2011.2020. Available online:
      www.efsa.europa.eu

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

      (9)  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

                  1-naphthylacetamide
                  CAS No 86-86-2
                  CIPAC No 282

                  2-(1-naphthyl)acetamide

                  ≥ 980 g/kg

                  1 January 2012

                  31 December 2021

                  PART A
                  Only uses as plant growth regulator 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 1-naphthylacetamide, 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 ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;

                              (b)

                              shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

                              (c)

                              shall pay particular attention to the risk to aquatic organisms;

                              (d)

                              shall pay particular attention to the risk to non-target plants;

                              (e)

                              shall pay particular attention to the risk to birds.

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

                              (1)

                              the risk to non-target plants;

                              (2)

                              the long-term risk to birds.

                        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

                     ‘12

                     1-naphthylacetamide
                     CAS No 86-86-2
                     CIPAC No 282

                     2-(1-naphthyl)acetamide

                     ≥ 980 g/kg

                     1 January 2012

                     31 December 2021

                     PART A
                     Only uses as plant growth regulator 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 1-naphthylacetamide, 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 ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;

                                 (b)

                                 shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

                                 (c)

                                 shall pay particular attention to the risk to aquatic organisms;

                                 (d)

                                 shall pay particular attention to the risk to non-target plants;

                                 (e)

                                 shall pay particular attention to the risk to birds.

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

                                 (1)

                                 the risk to non-target plants;

                                 (2)

                                 the long-term risk to birds.

                           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 878/2014 of 12 August 2014 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances dichlorprop-P, metconazole and triclopyr  Text with EEA relevance

text:
               13.8.2014

               EN

               Official Journal of the European Union

               L 240/18

         COMMISSION IMPLEMENTING REGULATION (EU) No 878/2014
   of 12 August 2014
   amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances dichlorprop-P, metconazole and triclopyr
   (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 dichlorprop-P, metconazole and triclopyr 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)

               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 Plants, Animals, Food and Feed,

         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, 12 August 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 Implementing Regulation (EU) No 540/2011 is amended as follows:

                  (1)

                  In the sixth column, expiration of approval, of row 133, dichlorprop-P, the date of ‘31 May 2017’ is replaced by ‘30 April 2018’;

                  (2)

                  In the sixth column, expiration of approval, of row 134, metconazole, the date of ‘31 May 2017’ is replaced by ‘30 April 2018’;

                  (3)

                  In the sixth column, expiration of approval, of row 136, triclopyr, the date of ‘31 May 2017’ is replaced by ‘30 April 2018’.


title: Commission Implementing Regulation (EU) No 820/2011 of 16 August 2011 approving the active substance terbuthylazine, 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:
               17.8.2011

               EN

               Official Journal of the European Union

               L 209/18

         COMMISSION IMPLEMENTING REGULATION (EU) No 820/2011
   of 16 August 2011
   approving the active substance terbuthylazine, 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. Terbuthylazine 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 terbuthylazine.

               (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 two 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 terbuthylazine.

               (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 the United Kingdom, 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)

               The United Kingdom 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 3 February 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 terbuthylazine to the Commission on 20 December 2010 (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 terbuthylazine.

               (7)

               It has appeared from the various examinations made that plant protection products containing terbuthylazine 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 terbuthylazine 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 terbuthylazine 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 six months after approval to review authorisations of plant protection products containing terbuthylazine. 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 terbuthylazine and the withdrawal of authorisations for plants protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning terbuthylazine 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 terbuthylazine, 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 terbuthylazine 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 terbuthylazine 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 terbuthylazine 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 terbuthylazine 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 terbuthylazine 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, 16 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 terbuthylazine. EFSA Journal 2011; 9(1):1969 [133 pp.], doi:10.2903/j.efsa.2010.1969. 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

                  Terbuthylazine
                  CAS No 5915-41-3
                  CIPAC No 234

                  N2-tert-butyl-6-chloro-N4-ethyl-1,3,5-triazine-2,4-diamine

                  ≥ 950 g/kg
                  Impurities:

                              Propazine not more than 10 g/kg

                              Atrazine not more than 1 g/kg

                              Simazine not more than 30 g/kg

                  1 January 2012

                  31 December 2021

                  PART A
                  Only uses as herbicide 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 terbuthylazine, 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 shall pay particular attention to:

                              (a)

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

                              (b)

                              the risk to mammals and earthworms.

                        Conditions of use shall include risk mitigation measures and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate.
                  The applicant shall submit confirmatory information as regards:

                              (1)

                              the specification of the technical material, as commercially manufactured including information on the relevance of the impurities;

                              (2)

                              the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies;

                              (3)

                              groundwater exposure assessment for the unidentified metabolites LM1, LM2, LM3, LM4, LM5 and LM6;

                              (4)

                              the relevance of the metabolites MT1 (N-tert-butyl-6-chloro-1,3,5-triazine-2,4-diamine), MT 13 (4-(tert-butylamino)-6-(ethylamino)-1,3,5-triazin-2-ol or 6-hydroxy-N2-ethyl-N4-tert-butyl-1,3,5-triazine-2,4-diamine), MT14 (4-amino-6-(tert-butylamino)-1,3,5-triazin-2-ol or N-tert-butyl-6-hydroxy-1,3,5-triazine-2,4-diamine), and of the unidentified metabolites LM1, LM2, LM3, LM4, LM5 and LM6 with respect to cancer, if terbuthylazine is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’.

                        The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) and (2) by 30 June 2012, the information set out in point (3) by 30 June 2013 and the information set out in point (4) within six months from the notification of the classification decision concerning that substance.

         (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

                     ‘16

                     Terbuthylazine
                     CAS No 5915-41-3
                     CIPAC No 234

                     N2-tert-butyl-6-chloro-N4-ethyl-1,3,5-triazine-2,4-diamine

                     ≥ 950 g/kg
                     Impurities:

                                 Propazine not more than 10 g/kg

                                 Atrazine not more than 1 g/kg

                                 Simazine not more than 30 g/kg

                     1 January 2012

                     31 December 2021

                     PART A
                     Only uses as herbicide 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 terbuthylazine, 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 shall pay particular attention to:

                                 (a)

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

                                 (b)

                                 the risk to mammals and earthworms.

                           Conditions of use shall include risk mitigation measures and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate.
                     The applicant shall submit confirmatory information as regards:

                                 (1)

                                 the specification of the technical material, as commercially manufactured, by appropriate analytical data, including information on the relevance of the impurities;

                                 (2)

                                 the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies;

                                 (3)

                                 groundwater exposure assessment for the unidentified metabolites LM1, LM2, LM3, LM4, LM5 and LM6;

                                 (4)

                                 the relevance of the metabolites MT1 (N-tert-butyl-6-chloro-1,3,5-triazine-2,4-diamine), MT 13 (4-(tert-butylamino)-6-(ethylamino)-1,3,5-triazin-2-ol or 6-hydroxy-N2-ethyl-N4-tert-butyl-1,3,5-triazine-2,4-diamine), MT14 (4-amino-6-(tert-butylamino)-1,3,5-triazin-2-ol or N-tert-butyl-6-hydroxy-1,3,5-triazine-2,4-diamine), and of the unidentified metabolites LM1, LM2, LM3, LM4, LM5 and LM6 with respect to cancer, if terbuthylazine is classified under Regulation (EC) No 1272/2008 as “suspected of causing cancer”.

                           The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) and (2) by 30 June 2012, the information set out in point (3) by 30 June 2013 and the information set out in point (4) within six months from the notification of the classification decision concerning that substance.’

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


title: Commission Implementing Regulation (EU) 2015/404 of 11 March 2015 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances beflubutamid, captan, dimethoate, dimethomorph, ethoprophos, fipronil, folpet, formetanate, glufosinate, methiocarb, metribuzin, phosmet, pirimiphos-methyl and propamocarb  Text with EEA relevance

text:
               12.3.2015

               EN

               Official Journal of the European Union

               L 67/6

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/404
   of 11 March 2015
   amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances beflubutamid, captan, dimethoate, dimethomorph, ethoprophos, fipronil, folpet, formetanate, glufosinate, methiocarb, metribuzin, phosmet, pirimiphos-methyl and propamocarb
   (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 captan, dimethoate, dimethomorph, ethoprophos, fipronil, folpet, formetanate, glufosinate, methiocarb, metribuzin, phosmet, pirimiphos-methyl and propamocarb will expire on 30 September 2017 and that of the active substance beflubutamid will expire on 30 November 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 Plants, Animals, Food and Feed,

         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, 11 March 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (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 Implementing Regulation (EU) No 540/2011 is amended as follows:

                  (1)

                  in the sixth column, expiration of approval, of row 145, captan, the date of ‘30 September 2017’ is replaced by ‘31 July 2018’;

                  (2)

                  in the sixth column, expiration of approval, of row 146, folpet, the date of ‘30 September 2017’ is replaced by ‘31 July 2018’;

                  (3)

                  in the sixth column, expiration of approval, of row 147, formetanate, the date of ‘30 September 2017’ is replaced by ‘31 July 2018’;

                  (4)

                  in the sixth column, expiration of approval, of row 148, methiocarb, the date of ‘30 September 2017’ is replaced by ‘31 July 2018’;

                  (5)

                  in the sixth column, expiration of approval, of row 149, dimethoate, the date of ‘30 September 2017’ is replaced by ‘31 July 2018’;

                  (6)

                  in the sixth column, expiration of approval, of row 150, dimethomorph, the date of ‘30 September 2017’ is replaced by ‘31 July 2018’;

                  (7)

                  in the sixth column, expiration of approval, of row 151, glufosinate, the date of ‘30 September 2017’ is replaced by ‘31 July 2018’;

                  (8)

                  in the sixth column, expiration of approval, of row 152, metribuzin, the date of ‘30 September 2017’ is replaced by ‘31 July 2018’;

                  (9)

                  in the sixth column, expiration of approval, of row 153, phosmet, the date of ‘30 September 2017’ is replaced by ‘31 July 2018’;

                  (10)

                  in the sixth column, expiration of approval, of row 154, propamocarb, the date of ‘30 September 2017’ is replaced by ‘31 July 2018’;

                  (11)

                  in the sixth column, expiration of approval, of row 155, ethoprophos, the date of ‘30 September 2017’ is replaced by ‘31 July 2018’;

                  (12)

                  in the sixth column, expiration of approval, of row 156, pirimiphos-methyl, the date of ‘30 September 2017’ is replaced by ‘31 July 2018’;

                  (13)

                  in the sixth column, expiration of approval, of row 157, fipronil, the date of ‘30 September 2017’ is replaced by ‘31 July 2018’;

                  (14)

                  in the sixth column, expiration of approval, of row 158, beflubutamid, the date of ‘30 November 2017’ is replaced by ‘31 July 2018’.


title: Commission Implementing Regulation (EU) No 673/2011 of 13 July 2011 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               14.7.2011

               EN

               Official Journal of the European Union

               L 184/2

         COMMISSION IMPLEMENTING REGULATION (EU) No 673/2011
   of 13 July 2011
   establishing the standard import values for determining the entry price of certain fruit and vegetables
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),
   Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
   Whereas:
   Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto,
   HAS ADOPTED THIS REGULATION:
   Article 1
   The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex hereto.
   Article 2
   This Regulation shall enter into force on 14 July 2011.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 13 July 2011.

            For the Commission, On behalf of the President,
         José Manuel SILVA RODRÍGUEZ

            Director-General for Agriculture and Rural Development

      (1)  OJ L 299, 16.11.2007, p. 1.

      (2)  OJ L 157, 15.6.2011, p. 1.

      ANNEX
      Standard import values for determining the entry price of certain fruit and vegetables

                  (EUR/100 kg)

                  CN code

                  Third country code (1)

                  Standard import value

                  0702 00 00

                  AL

                  49,0

                  EC

                  20,9

                  MK

                  43,1

                  ZZ

                  37,7

                  0707 00 05

                  TR

                  105,8

                  ZZ

                  105,8

                  0709 90 70

                  AR

                  27,2

                  EC

                  26,5

                  TR

                  110,5

                  ZZ

                  54,7

                  0805 50 10

                  AR

                  58,1

                  TR

                  64,0

                  UY

                  64,3

                  ZA

                  71,5

                  ZZ

                  64,5

                  0808 10 80

                  AR

                  136,0

                  BR

                  81,7

                  CA

                  106,0

                  CL

                  91,3

                  CN

                  87,0

                  EC

                  60,7

                  NZ

                  112,4

                  US

                  150,8

                  ZA

                  100,9

                  ZZ

                  103,0

                  0808 20 50

                  AR

                  110,0

                  AU

                  75,6

                  CL

                  110,0

                  CN

                  81,6

                  NZ

                  118,4

                  ZA

                  111,3

                  ZZ

                  101,2

                  0809 10 00

                  AR

                  75,0

                  TR

                  220,1

                  XS

                  138,6

                  ZZ

                  144,6

                  0809 20 95

                  CL

                  298,8

                  SY

                  253,3

                  TR

                  297,8

                  ZZ

                  283,3

                  0809 40 05

                  BA

                  62,0

                  EC

                  75,9

                  ZZ

                  69,0

         (1)  Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘ZZ’ stands for ‘of other origin’.


title: Commission Implementing Regulation (EU) No 736/2011 of 26 July 2011 approving the active substance fluroxypyr, 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:
               27.7.2011

               EN

               Official Journal of the European Union

               L 195/37

         COMMISSION IMPLEMENTING REGULATION (EU) No 736/2011
   of 26 July 2011
   approving the active substance fluroxypyr, 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)(b) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply to active substances listed in Annex I to Commission Regulation (EC) No 737/2007 of 27 June 2007 on laying down the procedure of the renewal of the inclusion of a first group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances (3), with respect to the procedure and the conditions for approval. Fluroxypyr is listed in Annex I to Regulation (EC) No 737/2007.

               (2)

               The approval of fluroxypyr, as set out in 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 (4), expires on 31 December 2011. A notification was submitted in accordance with Article 4 of Regulation (EC) No 737/2007 for the renewal of the inclusion of fluroxypyr in Annex I to Directive 91/414/EEC within the time period provided for in that Article.

               (3)

               That notification was found to be admissible by Commission Decision 2008/656/EC of 28 July 2008 on the admissibility of the notifications concerning the renewal of the inclusion in Annex I to Council Directive 91/414/EEC of the active substances azimsulfuron, azoxystrobin, fluroxypyr, imazalil, kresoxim-methyl, prohexadione and spiroxamine, and establishing the list of the notifiers concerned (5).

               (4)

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

               (5)

               The rapporteur Member State prepared an assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 26 November 2009. In addition to the assessment of the active substance, that report includes a list of the studies the rapporteur Member State relied on for its assessment.

               (6)

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

               (7)

               At the request of the Commission, the assessment report was peer reviewed by the Member States and the Authority. The Authority presented its conclusion on the peer review of the risk assessment of fluroxypyr (6) to the Commission on 24 February 2011. The 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 17 June 2011 in the format of the Commission review report for fluroxypyr.

               (8)

               It has appeared from the various examinations made that plant protection products containing fluroxypyr may be expected to continue to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular as regards the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve fluroxypyr.

               (9)

               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 not provided for in the first inclusion in Annex I to Directive 91/414/EEC.

               (10)

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

               (11)

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

               (12)

               Without prejudice to the obligations provided for by 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 6 months after approval to review authorisations of plant protection products containing fluroxypyr. 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.

               (13)

               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 (7) 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.

               (14)

               In accordance with Article 13(4) of Regulation (EC) No 1107/2009 the Annex to Implementing Regulation (EU) No 540/2011 should be amended 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 fluroxypyr, 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 fluroxypyr 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 fluroxypyr 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 still 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 fluroxypyr 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 fluroxypyr 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
   Entry into force and 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, 26 July 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 169, 29.6.2007, p. 10.

      (4)  OJ L 153, 11.6.2011, p. 1.

      (5)  OJ L 214, 9.8.2008, p. 70.

      (6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance fluroxypyr. EFSA Journal 2011;9(3):2091. [91 pp.]. doi:10.2903/j.efsa.2011.2091. Available online: www.efsa.europa.eu/efsajournal.htm

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

      ANNEX I

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  Fluroxypyr
                  CAS No 69377-81-7
                  CIPAC No 431

                  4-amino-3,5-dichloro-6-fluoro-2-pyridyloxyacetic acid

                  ≥ 950 g/kg
                  (fluroxypyr-meptyl)

                  1 January 2012

                  31 December 2021

                  PART A
                  Only uses as herbicide 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 fluroxypyr, 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 shall:

                              (1)

                              pay particular attention to the potential contamination of groundwater by metabolite fluroxypyr pyridinol, when the active substance is applied in regions with alkaline or vulnerable soil and/or with vulnerable climatic conditions;

                              (2)

                              pay particular attention to the risk to aquatic organisms.

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

                              (a)

                              the relevance of the impurities present in the technical specifications;

                              (b)

                              the relevance of the test material used in the toxicity dossiers in view of the specification of the technical material;

                              (c)

                              the toxicological relevance of the metabolites fluroxypyr pyridinol and fluroxypyr methoxypyridine;

                              (d)

                              the residue analytical methods for plants;

                              (e)

                              the fate of fluroxypyr esters in animal matrices;

                              (f)

                              the long-term risk for earthworms and soil organisms.

                        The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) and (b) by 1 July 2012 and the information set out in points (c), (d), (e) and (f) by 31 December 2013.

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

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

                  (1)

                  in Part A, the entry relating to fluroxypyr is deleted;

                  (2)

                  in Part B, the following entry is added:

                              No

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity (1)

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‘9

                              Fluroxypyr
                              CAS No 69377-81-7
                              CIPAC No 431

                              4-amino-3,5-dichloro-6-fluoro-2-pyridyloxyacetic acid

                              ≥ 950 g/kg
                              (fluroxypyr-meptyl)

                              1 January 2012

                              31 December 2021

                              PART A
                              Only uses as herbicide 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 fluroxypyr, 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 shall:

                                          (1)

                                          pay particular attention to the potential contamination of groundwater by metabolite fluroxypyr pyridinol, when the active substance is applied in regions with alkaline or vulnerable soil and/or with vulnerable climatic conditions;

                                          (2)

                                          pay particular attention to the risk to aquatic organisms.

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

                                          (a)

                                          the relevance of the impurities present in the technical specifications;

                                          (b)

                                          the relevance of the test material used in the toxicity dossiers in view of the specification of the technical material;

                                          (c)

                                          the toxicological relevance of the metabolites fluroxypyr pyridinol and fluroxypyr methoxypyridine;

                                          (d)

                                          the residue analytical methods for plants;

                                          (e)

                                          the fate of fluroxypyr esters in animal matrices;

                                          (f)

                                          the long-term risk for earthworms and soil organisms.

                                    The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) and (b) by 1 July 2012 and the information set out in points (c), (d), (e) and (f) 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 188/2013 of 5 March 2013 approving the active substance mandipropamid, 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:
               6.3.2013

               EN

               Official Journal of the European Union

               L 62/13

         COMMISSION IMPLEMENTING REGULATION (EU) No 188/2013
   of 5 March 2013
   approving the active substance mandipropamid, 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 mandipropamid the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2006/589/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC Austria received on 13 December 2005 an application from Syngenta Crop Protection AG for the inclusion of the active substance mandipropamid in Annex I to Directive 91/414/EEC. Decision (2006/589/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 30 November 2006.

               (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 mandipropamid (4) on 18 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 was finalised on 1 February 2013 in the format of the Commission review report for mandipropamid.

               (5)

               It has appeared from the various examinations made that plant protection products containing mandipropamid 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 mandipropamid.

               (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 mandipropamid. 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 mandipropamid, 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 mandipropamid as an active substance by 31 January 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 mandipropamid 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 July 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 mandipropamid as the only active substance, where necessary, amend or withdraw the authorisation by 31 January 2015 at the latest; or

               (b)

               in the case of a product containing mandipropamid as one of several active substances, where necessary, amend or withdraw the authorisation by 31 January 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
   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 August 2013.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 5 March 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 240, 9.9.2006, p. 9.

      (4)  EFSA Journal 2012; 10(11):2935. 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

                  Mandipropamid
                  CAS No 374726-62-2
                  CIPAC No 783

                  (RS)-2-(4-chlorophenyl)-N-[3-methoxy-4-(prop-2-ynyloxy)phenethyl]-2-(prop-2-ynyloxy)acetamide

                  ≥ 930 g/kg
                  The impurity N-{2-[4-(2-chloro-allyloxy)-3-methoxy-phenyl]-ethyl}-2-(4-chloro-phenyl)-2-prop-2-ynyloxy-acetamide is of toxicological relevance and shall not exceed 0,1 g/kg in the technical material.

                  1 August 2013

                  31 July 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 mandipropamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account.
                  Conditions of use shall include risk mitigation measures, where appropriate.
                  The applicant shall submit confirmatory information as regards the potential for preferential enantiomeric transformation or racemisation of mandipropamid at the soil surface as a result of soil photolysis.
                  The applicant shall submit to the Commission, the Member States and the Authority that information by 31 July 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

                     ‘34

                     Mandipropamid
                     CAS No 374726-62-2
                     CIPAC No 783

                     (RS)-2-(4-chlorophenyl)-N-[3-methoxy-4-(prop-2-ynyloxy)phenethyl]-2-(prop-2-ynyloxy)acetamide

                     ≥ 930 g/kg
                     The impurity N-{2-[4-(2-chloro-allyloxy)-3-methoxy-phenyl]-ethyl}-2-(4-chloro-phenyl)-2-prop-2-ynyloxy-acetamide is of toxicological relevance and shall not exceed 0,1 g/kg in the technical material.

                     1 August 2013

                     31 July 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 mandipropamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account.
                     Conditions of use shall include risk mitigation measures, where appropriate.
                     The applicant shall submit confirmatory information as regards the potential for preferential enantiomeric transformation or racemisation of mandipropamid at the soil surface as a result of soil photolysis.
                     The applicant shall submit to the Commission, the Member States and the Authority that information by 31 July 2015’.

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