title: Commission Implementing Regulation (EU) No 810/2011 of 11 August 2011 approving the active substance kresoxim-methyl, 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:
               12.8.2011

               EN

               Official Journal of the European Union

               L 207/7

         COMMISSION IMPLEMENTING REGULATION (EU) No 810/2011
   of 11 August 2011
   approving the active substance kresoxim-methyl, 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 Articles 13(2) and 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. Kresoxim-methyl is listed in Annex I to Regulation (EC) No 737/2007.

               (2)

               The approval of kresoxim-methyl, 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 kresoxim-methyl 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. 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 kresoxim-methyl (6) to the Commission. 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 kresoxim-methyl.

               (8)

               It has appeared from the various examinations made that plant protection products containing kresoxim-methyl 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 kresoxim-methyl.

               (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 kresoxim-methyl 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 kresoxim-methyl. 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 kresoxim-methyl, 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 kresoxim-methyl 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 kresoxim-methyl 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 kresoxim-methyl 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 kresoxim-methyl 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, 11 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 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 kresoxim-methyl. EFSA Journal 2010;8(11):1891. [88 pp.]. doi:10.2903/j.efsa.2010.1891. Available online: www.efsa.europa.eu/efsajournal.htm

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

      ANNEX I
      Conditions of approval as active substance under Regulation (EC) No 1107/2009:

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  Kresoxim-methyl
                  CAS No 143 390-89-0
                  CIPAC No 568

                  methyl (E)-methoxyimino[a-(o-tolyloxy)-o-tolyl]acetate

                  ≥ 910 g/kg
                  Methanol: max. 5 g/kg
                  Methyl chloride: max. 1 g/kg
                  Toluene: max. 1 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 kresoxim-methyl 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.
                  Member States shall pay particular attention to the protection of groundwater under vulnerable conditions; the conditions of authorisation shall include, where appropriate, risk mitigation measures.
                  The applicant shall submit confirmatory information as regards:
                  Groundwater exposure risk assessment, and in particular:

                              —

                              on the lysimeter study to support the statement that the two unidentified peaks observed do not correspond to metabolites individually exceeding the trigger value of 0,1 μg/L,

                              —

                              on the recovery of metabolite BF 490-5 in order to confirm its absence in the lysimeter leachate at levels exceeding 0,1 μg/L,

                              —

                              on a groundwater exposure risk assessment for the late application in apples, pears and grapes.

                        The applicant shall submit to the Member States, the Commission 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
      The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

                  (1)

                  in Part A, the entry relating to kresoxim-methyl 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

                              ‘8

                              Kresoxim-methyl
                              CAS No 143 390-89-0
                              CIPAC No 568

                              methyl (E)-methoxyimino[a-(o-tolyloxy)-o-tolyl]acetate

                              ≥ 910 g/kg
                              Methanol: max. 5 g/kg
                              Methyl chloride: max. 1 g/kg
                              Toluene: max. 1 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 kresoxim-methyl 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.
                              Member States shall pay particular attention to the protection of groundwater under vulnerable conditions; the conditions of authorisation shall include, where appropriate, risk mitigation measures.
                              The applicant shall submit confirmatory information as regards:
                              Groundwater exposure risk assessment, and in particular:

                                          —

                                          on the lysimeter study to support the statement that the two unidentified peaks observed do not correspond to metabolites individually exceeding the trigger value of 0,1 μg/L,

                                          —

                                          on the recovery of metabolite BF 490-5 in order to confirm its absence in the lysimeter leachate at levels exceeding 0,1 μg/L,

                                          —

                                          on a groundwater exposure risk assessment for the late application in apples, pears and grapes.

                                    The applicant shall submit to the Member States, the Commission 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 807/2011 of 10 August 2011 approving the active substance triazoxide, 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:
               11.8.2011

               EN

               Official Journal of the European Union

               L 206/44

         COMMISSION IMPLEMENTING REGULATION (EU) No 807/2011
   of 10 August 2011
   approving the active substance triazoxide, 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 Articles 13(2) and 78(3) 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. Triazoxide 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 third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included triazoxide. By Commission Decision 2009/860/EC (6) it was decided not to include triazoxide in Annex I to Directive 91/414/EEC.

               (3)

               Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the application of 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.

               (4)

               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 those that were the subject of Decision 2009/860/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

               (5)

               The United Kingdom evaluated the new information and 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 10 June 2010.

               (6)

               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 additional report was peer reviewed by the Member States and the Authority. The Authority then presented its conclusion on triazoxide 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 triazoxide.

               (7)

               The additional report by the rapporteur Member State and the new conclusion by the Authority concentrate on the concerns that led to the non-inclusion. Those concerns were in particular that it was not possible to perform a reliable consumer risk assessment as data were missing to determine the nature of residues in plant commodities and the possible transfer of residues in animal products.

               (8)

               The new information submitted by the applicant shows that the exposure of consumers may be considered as acceptable.

               (9)

               Consequently, the additional information provided by the applicant permit to eliminate the specific concerns that led to the non-inclusion. No other open scientific questions have arisen.

               (10)

               It has appeared from the various examinations made that plant protection products containing triazoxide 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 triazoxide in accordance with Regulation (EC) No 1107/2009.

               (11)

               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.

               (12)

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

               (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 (8), should be amended accordingly.

               (14)

               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 triazoxide, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
   Article 2
   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 3
   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 October 2011.

      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 314, 1.12.2009, p. 81.

      (7)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance triazoxide. EFSA Journal 2011;9(3): [86 pp.] doi:10.2903/j.efsa.2011.2018. Available online:
      www.efsa.europa.eu/efsajournal.htm

      (8)  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

                  Triazoxide
                  CAS No 72459-58-6
                  CIPAC No 729

                  7-chloro-3-imidazol-1-yl-1,2,4-benzotriazine 1-oxide

                  ≥ 970 g/kg
                  Impurities:
                  toluene: not more than 3 g/kg

                  1 October 2011

                  30 September 2021

                  PART A
                  Only uses as fungicide for seed treatment 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 triazoxide, 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 protection of 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 risk to granivorous birds and shall ensure that conditions of authorisation include risk mitigation measures.

                        The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the long-term risk to granivorous mammals by 30 September 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:

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘17

                     Triazoxide
                     CAS No 72459-58-6
                     CIPAC No 729

                     7-chloro-3-imidazol-1-yl-1,2,4-benzotriazine 1-oxide

                     ≥ 970 g/kg
                     Impurities:
                     toluene: not more than 3 g/kg

                     1 October 2011

                     30 September 2021

                     PART A
                     Only uses as fungicide for use as seed treatment 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 triazoxide, 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 protection of 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 risk to granivorous birds and shall ensure that conditions of authorisation include risk mitigation measures.

                           The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the long-term risk to granivorous mammals by 30 September 2013.’

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


title: Commission Implementing Regulation (EU) No 1178/2013 of 20 November 2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance ethoprophos  Text with EEA relevance

text:
               21.11.2013

               EN

               Official Journal of the European Union

               L 312/33

      COMMISSION IMPLEMENTING REGULATION (EU) No 1178/2013
   of 20 November 2013
   amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance ethoprophos
   (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 Articles 21(3) and 78(2) thereof,
   Whereas:

               (1)

               Commission Directive 2007/52/EC (2) included ethoprophos 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 ethoprophos was included in that Annex provides further confirmatory information in the form of studies on the risk for birds and earthworm eating 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 taking the form of studies concerning the risk for birds and earthworm eating mammals to the rapporteur Member State United Kingdom within the time period provided for its submission.

               (4)

               The United Kingdom 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 5 September 2011.

               (5)

               The Commission consulted the Authority which presented its opinion on the risk assessment of ethoprophos on 30 January 2013 (5). The draft assessment report, the addendum and the opinion 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 ethoprophos.

               (6)

               The Commission invited the notifier to submit its comments on the review report for ethoprophos.

               (7)

               The Commission has come to the conclusion that the further confirmatory information showed that a high risk for birds and earthworm eating mammals cannot be excluded except by imposing further restrictions.

               (8)

               It is confirmed that the active substance ethoprophos is to be deemed to have been approved under Regulation (EC) No 1107/2009. In order to minimise the exposure of birds and earthworm eating 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 amend or withdraw authorisations for plant protection products containing ethoprophos.

               (11)

               For plant protection products containing ethoprophos, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, this period should expire at the latest 18 months after the entry into force of the Regulation.

               (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 ethoprophos as active substance by 11 June 2014.
   Article 3
   Grace period
   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 11 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, 20 November 2013.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  Commission Directive 2007/52/EC of 16 August 2007 amending Council Directive 91/414/EEC to include ethoprophos, pirimiphos-methyl and fipronil as active substances (OJ L 214, 17.8.2007, p. 3).

      (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)  Conclusion on the peer review of the pesticide risk assessment of confirmatory data submitted for the active substance ethoprophos. EFSA Journal 2013; 11(2):3089. [27 pp.] doi:10.2903/j.efsa.2013.3089. Available online: www.efsa.europa.eu/efsajournal.htm

      ANNEX
      The column ‘Specific provisions’ of row 155, ethoprophos, of Part A of the Annex to Implementing Regulation (EU) No 540/2011 is replaced by the following:

         ‘PART A
         Only uses as nematicide and insecticide in soil application may be authorised. Only one application per season may be authorised, at a rate not exceeding 6 kg active substance/ha.
         Authorisations shall be limited to professional users.
         PART B
         In assessing applications to authorise plant protection products containing ethoprophos for uses other than potatoes not cultivated for human or animal consumption, Member States shall pay particular attention to the criteria in Article 29(1) of Regulation (EC) No 1107/2009 and shall ensure that any necessary data and information is provided before such an authorisation is granted.
         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 ethoprophos, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 March 2007, shall be taken into account.
         In this overall assessment Member States shall pay particular attention to:

                     (a)

                     the dietary exposure of consumers;

                     (b)

                     the operator safety, ensuring that the conditions of use prescribe the application of adequate personal and respiratory protective equipment and other risk mitigation measures such as the use of a closed transfer system for the distribution of the product;

                     (c)

                     the protection of birds, mammals, aquatic organisms, surface and groundwater under vulnerable conditions.

               Conditions of authorisation shall include risk mitigation measures, such as buffer zones and the achievement of complete incorporation of granules in the soil.’


title: Commission Implementing Regulation (EU) No 373/2013 of 23 April 2013 approving the active substance Candida oleophila strain O, 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:
               24.4.2013

               EN

               Official Journal of the European Union

               L 112/10

         COMMISSION IMPLEMENTING REGULATION (EU) No 373/2013
   of 23 April 2013
   approving the active substance Candida oleophila strain O, 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 Candida oleophila strain O the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2007/380/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 12 July 2006 an application from Bionext sprl for the inclusion of the active substance Candida oleophila strain O in Annex I to Directive 91/414/EEC. Decision 2007/380/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 15 November 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 Candida oleophila strain O (4) on 24 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 15 March 2013 in the format of the Commission review report for Candida oleophila strain O.

               (5)

               It has appeared from the various examinations made that plant protection products containing Candida oleophila strain O 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 Candida oleophila strain O.

               (6)

               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.

               (7)

               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 Candida oleophila strain O. 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.

               (8)

               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.

               (9)

               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.

               (10)

               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 Candida oleophila strain O, 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 Candida oleophila strain O as an active substance by 31 March 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 Candida oleophila strain O 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 September 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 Candida oleophila strain O as the only active substance, where necessary, amend or withdraw the authorisation by 31 March 2015 at the latest; or

               (b)

               in the case of a product containing Candida oleophila strain O as one of several active substances, where necessary, amend or withdraw the authorisation by 31 March 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 October 2013.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 23 April 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 141, 2.6.2007, p. 78.

      (4)  EFSA Journal 2012; 10(11):2944. 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

                     Candida oleophila strain O
                  Collection number: MUCL40654

                  Not applicable

                  Nominal content: 3 × 1010 CFU/g dried product
                  Range: 6 × 109 – 1 × 1011 CFU/g dried product

                  1 October 2013

                  30 September 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 Candida oleophila strain O, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.

         (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

                     ‘37

                        Candida oleophila strain O
                     Collection number: MUCL40654

                     Not applicable

                     Nominal content: 3 × 1010 CFU/g dried product
                     Range: 6 × 109 – 1 × 1011 CFU/g dried product

                     1 October 2013

                     30 September 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 Candida oleophila strain O, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.’

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


title: Commission Implementing Regulation (EU) No 798/2013 of 21 August 2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance pyrethrins  Text with EEA relevance

text:
               22.8.2013

               EN

               Official Journal of the European Union

               L 224/9

         COMMISSION IMPLEMENTING REGULATION (EU) No 798/2013
   of 21 August 2013
   amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance pyrethrins
   (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)(c) thereof,
   Whereas:

               (1)

               The active substance pyrethrins was included in Annex I to Council Directive 91/414/EEC (2) by Commission Directive 2008/127/EC (3) in accordance with the procedure provided for in Article 24b of Commission Regulation (EC) No 2229/2004 of 3 December 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 (4). Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, this substance is deemed to have been approved under that Regulation and is listed 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 (5).

               (2)

               In accordance with Article 25a of Regulation (EC) No 2229/2004, the European Food Safety Authority, hereinafter ‘the Authority’, presented to the Commission its view on the draft review report for pyrethrins (6) on 12 December 2012. The Authority communicated its view on pyrethrins to the notifier. The Commission invited it to submit comments on the draft review report for pyrethrins. The draft review report and the view 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 pyrethrins.

               (3)

               It is confirmed that the active substance pyrethrins is to be deemed to have been approved under Regulation (EC) No 1107/2009.

               (4)

               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 necessary to amend the conditions of approval of pyrethrins. In particular, it is appropriate to require further confirmatory information.

               (5)

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

               (6)

               A reasonable period of time should be allowed before the application of this Regulation in order to allow Member States, notifiers and holders of authorisations for plant protection products containing pyrethrins to meet the requirements resulting from amendment to the conditions of the approval.

               (7)

               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.
   It shall apply from 1 January 2014.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 21 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 344, 20.12.2008, p. 89.

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

      (5)  OJ L 153, 11.6.2011, p. 1.

      (6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance pyrethrins. EFSA Journal 2013;11(1):3032 [76 pp.] doi:10.2903/j.efsa.2013.3032. Available online: www.efsa.europa.eu/efsajournal

      ANNEX
      In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 246 on the active substance pyrethrins is replaced by the following:

                     Number

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘246

                     Pyrethrins: 8003-34-7
                     CIPAC No 32
                     Extract A: extractives of Chrysanthemum cinerariaefolium:
                     89997- 63-7
                     Pyrethrin 1: CAS 121- 21-1
                     Pyrethrin 2: CAS 121- 29-9
                     Cinerin 1: CAS 25402- 06-6
                     Cinerin 2: CAS 121- 20-0
                     Jasmolin 1: CAS 4466- 14-2
                     Jasmolin 2: CAS 1172- 63-0
                     Extract B:
                     Pyrethrin 1: CAS 121-21-1
                     Pyrethrin 2: CAS 121- 29-9
                     Cinerin 1: CAS 25402- 06-6
                     Cinerin 2: CAS 121- 20-0
                     Jasmolin 1: CAS 4466- 14-2
                     Jasmolin 2: CAS 1172- 63-0

                     Pyrethrins are a complex mixture of chemical substances.

                     Extract A: ≥ 500 g/kg Pyrethrins
                     Extract B: ≥ 480 g/kg Pyrethrins

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as insecticide 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 pyrethrins (SANCO/2627/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 (a)

                                 the risk to operators and workers;

                                 (b)

                                 the risk to non-target organisms.

                           Conditions of use shall, where appropriate, include the application of adequate personal protective equipment and other risk mitigation measures.
                     The applicant shall submit confirmatory information as regards:

                                 (1)

                                 the specification of the technical material, as commercially manufactured including information on any relevant impurities and its equivalence with the specifications of the test material used in the toxicity studies;

                                 (2)

                                 the risk from inhalation;

                                 (3)

                                 the residue definition;

                                 (4)

                                 the representativeness of the major component “pyrethrin 1” as regards the fate and behaviour in soil and water.

                           The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) by 31 March 2014 and the information set out in points (2), (3) and (4) by 31 December 2015.’


title: Commission Implementing Regulation (EU) No 1100/2011 of 31 October 2011 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances dicamba, difenoconazole, and imazaquin Text with EEA relevance

text:
               1.11.2011

               EN

               Official Journal of the European Union

               L 285/10

         COMMISSION IMPLEMENTING REGULATION (EU) No 1100/2011
   of 31 October 2011
   amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances dicamba, difenoconazole, and imazaquin
   (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) thereof,
   Whereas:

               (1)

               The active substances dicamba, difenoconazole and imazaquin were included in Annex I to Council Directive 91/414/EEC (2) by Commission Directive 2008/69/EC (3) in accordance with the procedure provided for in Article 11b of Commission Regulation (EC) No 1490/2002 of 14 August 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 amending Regulation (EC) No 451/2000 (4). Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, these substances are deemed to have been approved under that Regulation and are listed 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 (5).

               (2)

               In accordance with Article 12a of Regulation (EC) No 1490/2002, the European Food Safety Authority, hereinafter ‘the Authority’, presented to the Commission the conclusions on the peer review for difenoconazole (6), dicamba (7) and imazaquin (8) on 17 December 2010. These conclusions were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and were finalised on 27 September 2011 in the format of the Commission review reports for difenoconazole, dicamba, and imazaquin.

               (3)

               In accordance with Article 12(2) of Regulation (EC) No 1107/2009 the Commission invited the notifiers to submit their comments on the conclusions of the Authority. Furthermore, in accordance with Article 13(1) of that Regulation, the Commission invited the notifiers to submit comments on the draft review reports for dicamba, difenoconazole and imazaquin. The notifiers submitted their comments, which have been carefully examined.

               (4)

               It is confirmed that the active substances dicamba, difenoconazole and imazaquin are to be deemed to have been approved under Regulation (EC) No 1107/2009.

               (5)

               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 necessary to amend the conditions of approval of dicamba, difenoconazole and imazaquin. It is, in particular, appropriate to require further confirmatory information.

               (6)

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

               (7)

               A reasonable period of time should be allowed before the application of this Regulation in order to allow Member States, notifiers and holders of authorisations for plant protection products to meet the requirements resulting from amendment to the conditions of the approval.

               (8)

               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 20th day following its publication in the Official Journal of the European Union.
   It shall apply from 1 May 2012.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 31 October 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 172, 2.7.2008, p. 9.

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

      (5)  OJ L 153, 11.6.2011, p. 1.

      (6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance difenoconazole. EFSA Journal 2011; 9(1):1967. [71 pp.]. doi:10.2903/j.efsa.2011.1967. Available online: www.efsa.europa.eu/efsajournal.htm

      (7)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance dicamba. EFSA Journal 2011; 9(1):1965. [52 pp.] doi:10.2903/j.efsa.2011.1965. Available online: www.efsa.europa.eu/efsajournal.htm

      (8)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance imazaquin. EFSA Journal 2011; 9(1):1968. [57 pp.]. doi:10.2903/j.efsa.2011.1968. Available online: www.efsa.europa.eu/efsajournal.htm

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

                  (1)

                  Number 172 on the active substance dicamba is replaced by the following:

                              Number

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‘172

                              Dicamba
                              CAS No 1918-00-9
                              CIPAC No 85

                              3,6-dichloro-2-methoxybenzoic acid

                              ≥ 850 g/kg

                              1 January 2009

                              31 December 2018

                              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 dicamba, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account.
                              In this overall assessment Member States shall pay particular attention to the protection of non-target plants.
                              Conditions of use shall include adequate risk mitigation measures, where appropriate.
                              The notifier shall submit confirmatory information as regards:

                                          (a)

                                          the identification and quantification of a group of soil transformation products formed in a soil incubation study;

                                          (b)

                                          the potential for long range transport through the atmosphere.

                                    The notifier shall submit this information to the Member States, the Commission and the Authority by 30 November 2013.’

                  (2)

                  Number 173 on the active substance difenoconazole is replaced by the following:

                              Number

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‘173

                              Difenoconazole
                              CAS No 119446-68-3
                              CIPAC No 687

                              3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether

                              ≥ 940g/kg
                              Toluene maximum content: 5 g/kg

                              1 January 2009

                              31 December 2018

                              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 difenoconazole, and in particular Appendices Iand II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account.
                              In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms.
                              Conditions of use shall include adequate risk mitigation measures, where appropriate.
                              The notifier shall submit confirmatory information as regards:

                                          (a)

                                          further data on the specification of the technical material;

                                          (b)

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

                                          (c)

                                          the potential for endocrine disrupting effects on fish (fish full life cycle study) and the chronic risk to earthworms from the active substance and the metabolite CGA 205375 (1);

                                          (d)

                                          the possible impact of the variable isomer-ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and on the environment.

                                    The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by 31 May 2012, the information set out in points (b) and (c) by 30 November 2013 and the information set out in point (d) within 2 years from the adoption of specific guidance.’

                  (3)

                  Number 175 on the active substance imazaquin is replaced by the following:

                              Number

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‘175

                              Imazaquin
                              CAS No 81335-37-7
                              CIPAC No 699

                              2-[(RS)-4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl]quinoline-3-carboxylic acid

                              ≥ 960 g/kg (racemic mixture)

                              1 January 2009

                              31 December 2018

                              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 conclusionsof the review report on imazaquin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account
                              The notifier shall submit confirmatory information as regards:

                                          (a)

                                          further data on the specification of the technical material;

                                          (b)

                                          the possible impact of the variable isomer-ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and on the environment.

                                    The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by 31 May 2012 and the information set out in point (b) within 2 years from the adoption of specific guidance.’

         (1)  1-[2-[2-chloro-4-(4-chloro-phenoxy)-phenyl]-2-1H-[1,2,4]triazol-yl]-ethanol.


title: Commission Implementing Regulation (EU) No 834/2012 of 17 September 2012 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               18.9.2012

               EN

               Official Journal of the European Union

               L 251/47

         COMMISSION IMPLEMENTING REGULATION (EU) No 834/2012
   of 17 September 2012
   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:

               (1)

               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.

               (2)

               The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

         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 to this Regulation.
   Article 2
   This Regulation shall enter into force on the day 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, 17 September 2012.

            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

                  MK

                  59,9

                  XS

                  59,9

                  ZZ

                  59,9

                  0707 00 05

                  MK

                  31,3

                  TR

                  106,4

                  ZZ

                  68,9

                  0709 93 10

                  TR

                  112,4

                  ZZ

                  112,4

                  0805 50 10

                  AR

                  98,1

                  BO

                  100,6

                  CL

                  88,5

                  TR

                  97,0

                  UY

                  107,8

                  ZA

                  100,3

                  ZZ

                  98,7

                  0806 10 10

                  EG

                  180,7

                  MK

                  41,5

                  TN

                  197,3

                  TR

                  118,3

                  ZZ

                  134,5

                  0808 10 80

                  AR

                  201,7

                  BR

                  89,7

                  CL

                  117,0

                  NZ

                  115,6

                  US

                  120,9

                  ZA

                  108,3

                  ZZ

                  125,5

                  0808 30 90

                  AR

                  196,5

                  CN

                  49,3

                  TR

                  115,4

                  ZA

                  154,7

                  ZZ

                  129,0

                  0809 30

                  TR

                  160,5

                  ZZ

                  160,5

                  0809 40 05

                  BA

                  60,9

                  HR

                  73,9

                  IL

                  63,3

                  TR

                  107,6

                  XS

                  60,5

                  ZZ

                  73,2

         (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 215/2012 of 13 March 2012 amending for the 166th time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al Qaida network

text:
               14.3.2012

               EN

               Official Journal of the European Union

               L 74/4

         COMMISSION IMPLEMENTING REGULATION (EU) No 215/2012
   of 13 March 2012
   amending for the 166th time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al Qaida network
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 881/2002 of 27 May 2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al-Qaida network, (1) and in particular Article 7(1)(a) and 7a(1) thereof,
   Whereas:

               (1)

               Annex I to Regulation (EC) No 881/2002 lists the persons, groups and entities covered by the freezing of funds and economic resources under that Regulation.

               (2)

               On 5 March 2012 the Sanctions Committee of the United Nations Security Council decided to add one natural person to its list of persons, groups and entities to whom the freezing of funds and economic resources should apply.

               (3)

               Annex I to Regulation (EC) No 881/2002 should therefore be updated accordingly.

               (4)

               In order to ensure that the measures provided for in this Regulation are effective, this Regulation should enter into force immediately,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex I to Regulation (EC) No 881/2002 is amended in accordance with the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the day 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, 13 March 2012.

            For the Commission, On behalf of the President,

            Head of the Service for Foreign Policy Instruments

      (1)  OJ L 139, 29.5.2002, p. 9.

      ANNEX
      Annex I to Regulation (EC) No 881/2002 is amended as follows:
      The following entry shall be added under the heading ‘Natural persons’:

         ‘Fazal Rahim (alias (a) Fazel Rahim, (b) Fazil Rahim, (c) Fazil Rahman). Date of birth: (a) 5.1.1974 (b) 1977 (c) 1975 (d) 24.1.1973. Place of birth: Kabul, Afghanistan. Nationality: Afghan. Passport No.: Afghan passport number R512768. Address: (a) Afghanistan/Pakistan border region (previous address), (b) A2, City Computer Plaza, Shar-e-Now, Kabul, Afghanistan (previous address), (c) Microrayan 3rd, Apt. 45, block 21, Kabul, Afghanistan (previous address). Date of designation referred to in Article 2a(4)(b): 5.3.2012’


title: Commission Implementing Regulation (EU) No 1043/2012 of 8 November 2012 approving the active substance phosphane, 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:
               9.11.2012

               EN

               Official Journal of the European Union

               L 310/24

         COMMISSION IMPLEMENTING REGULATION (EU) No 1043/2012
   of 8 November 2012
   approving the active substance phosphane, 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 phosphane the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2008/566/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC Germany received on 11 November 2007 an application from S&A Service- und Anwendungstechnik GmbH for the inclusion of the active substance phosphane in Annex I to Directive 91/414/EEC. Decision 2008/566/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 24 February 2010.

               (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 phosphane (4) on 22 February 2012. The draft assessment report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and was finalised on 28 September 2012 in the format of the Commission review report for phosphane.

               (5)

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

               (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.

               (7)

               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 phosphane. 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.

               (8)

               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.

               (9)

               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.

               (10)

               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 phosphane, 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 phosphane as an active substance by 30 September 2013.
   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 phosphane 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 March 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 phosphane as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2014 at the latest; or

               (b)

               in the case of a product containing phosphane as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2014 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 April 2013.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 8 November 2012.

            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 181, 10.7.2008, p. 52.

      (4)  EFSA Journal 2012; 10(3):2595. Available online: http://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

                  Phosphane
                  CAS No 7803-51-2
                  CIPAC No 127

                  Phosphane

                  ≥ 994 g/kg
                  The relevant impurity arsane must not exceed 0,023 g/kg in the technical material

                  1 April 2013

                  31 March 2023

                  Authorisations shall be limited to professional users.
                  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 phosphane, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 September 2012 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              —

                              the protection of operators in and around the treated premises during the treatment as well as during and after the aeration;

                              —

                              the protection of workers in and around the treated premises during the treatment as well as during and after the aeration;

                              —

                              the protection of bystanders around the treated premises during the treatment as well as during and after the aeration.

                        Conditions of use shall include risk mitigation measures, like permanent monitoring of the phosphane concentration by automatic devices, the use of personal protection equipment and setting-up an area around the treated premise where bystanders are denied, 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

                     ‘28

                     Phosphane
                     CAS No 7803-51-2
                     CIPAC No 127

                     Phosphane

                     ≥ 994 g/kg
                     The relevant impurity arsane must not exceed 0,023 g/kg in the technical material

                     1 April 2013

                     31 March 2023

                     Authorisations shall be limited to professional users.
                     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 phosphane, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 September 2012 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 —

                                 the protection of operators in and around the treated premises during the treatment as well as during and after the aeration;

                                 —

                                 the protection of workers in and around the treated premises during the treatment as well as during and after the aeration;

                                 —

                                 the protection of bystanders around the treated premises during the treatment as well as during and after the aeration.

                           Conditions of use shall include risk mitigation measures, like permanent monitoring of the phosphane concentration by automatic devices, the use of personal protection equipment and setting-up an area around the treated premise where bystanders are denied, where appropriate.’

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


title: Commission Implementing Regulation (EU) No 287/2012 of 30 March 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance triflusulfuron  Text with EEA relevance

text:
               31.3.2012

               EN

               Official Journal of the European Union

               L 95/7

         COMMISSION IMPLEMENTING REGULATION (EU) No 287/2012
   of 30 March 2012
   amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance triflusulfuron
   (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)(c) thereof,
   Whereas:

               (1)

               By Commission Directive 2009/77/EC (2) triflusulfuron was included as active substance in Annex I to Council Directive 91/414/EEC (3) for uses as a herbicide in application on sugar and fodder beet at a maximum application rate of 60 g/ha only every third year on the same field. That inclusion was further restricted by a prohibition to feed foliage of treated crops to livestock. Regarding the purity of the active substance a limit of maximum 6 g/kg was set for the impurity N,N-dimethyl-6-(2,2,2-trifluoroethoxy)-1,3,5-triazine-2,4-diamine.

               (2)

               Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, this substance is deemed to have been approved under that Regulation and is listed 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).

               (3)

               On 25 June 2010 the notifier at whose request triflusulfuron was included in Annex I to Directive 91/414/EEC submitted an application for an amendment to the conditions of approval of triflusulfuron. It requested the removal of the restrictions on use as a herbicide and of the limit on the content of the impurity referred to in recital 1. That application was accompanied by additional information. It was submitted to France which had been designated rapporteur Member State by Commission Regulation (EC) No 1490/2002 (5).

               (4)

               The rapporteur Member State assessed the additional information submitted by the applicant and prepared an addendum to the draft assessment report. It submitted that addendum to the Commission on 17 December 2010 which communicated it to the other Member States and to the European Food Safety Authority for comments. The addendum to the draft assessment report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health on 9 March 2012 in the format of an addendum to the Commission review report for triflusulfuron.

               (5)

               It has appeared from the various examinations carried out that the amendment to the conditions of approval applied for does not cause any risks in addition to those already taken into account in the approval of triflusulfuron and in the Commission review report for that substance.

               (6)

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

               (7)

               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
   Row number 289, triflusulfuron, of Part A of the Annex is amended as follows:

               (1)

               the column purity is replaced by the following:
               ‘≥ 960 g/kg’;

               (2)

               in the column ‘Specific provisions’ Part A is replaced by the following:
               ‘PART A
               Only uses as a herbicide may be authorised.’.

         Article 2
   Entry into force
   This Regulation shall enter into force on the 20th day following 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, 30 March 2012.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  OJ L 172, 2.7.2009, p. 23.

      (3)  OJ L 230, 19.8.1991, p. 1.

      (4)  OJ L 153, 11.6.2011, p. 1.

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