title: Commission Implementing Regulation (EU) No 143/2014 of 14 February 2014 approving the active substance pyridalyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011  Text with EEA relevance

text:
               15.2.2014

               EN

               Official Journal of the European Union

               L 45/1

      COMMISSION IMPLEMENTING REGULATION (EU) No 143/2014
   of 14 February 2014
   approving the active substance pyridalyl, 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)(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 pyridalyl the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2007/669/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC Austria received on 9 October 2006 an application from Sumitomo Chemical Agro Europe S.A.S. for the inclusion of the active substance pyridalyl in Annex I to Directive 91/414/EEC. Decision 2007/669/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 8 January 2009.

               (4)

               The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance pyridalyl (4) on 24 May 2013. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 13 December 2013 in the format of the Commission review report for pyridalyl.

               (5)

               It has appeared from the various examinations made that plant protection products containing pyridalyl may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the use which was examined and detailed in the Commission review report. It is therefore appropriate to approve pyridalyl.

               (6)

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

               (7)

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

               (8)

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

               (9)

               The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (5) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

               (10)

               In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (6) should be amended accordingly.

               (11)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of active substance
   The active substance pyridalyl, 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 pyridalyl as an active substance by 31 December 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 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 pyridalyl 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 June 2014 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account 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 pyridalyl 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 pyridalyl 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 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 July 2014.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 14 February 2014.

            For the Commission

            The President

         José Manuel BARROSO

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

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

      (3)  Commission Decision 2007/669/EC of 15 October 2007 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of Adoxophyes orana granulovirus, amisulbrom, emamectin, pyridalil and Spodoptera littoralis nucleopolyhedrovirus in Annex I to Council Directive 91/414/EEC (OJ L 274, 18.10.2007, p. 15).

      (4)  EFSA Journal 2013;11(6):3240. Available online: www.efsa.europa.eu

      (5)  Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ L 366, 15.12.1992, p. 10).

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

      ANNEX I

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  Pyridalyl
                  CAS No 179101-81-6
                  CIPAC No 792

                  2,6-dichloro-4-(3,3-dichloroallyloxy)phenyl 3-[5-(trifluoromethyl)-2-pyridyloxy]propyl ether

                  ≥ 910 g/kg

                  1 July 2014

                  30 June 2024

                  PART A
                  Only uses in greenhouses with permanent structure 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 pyridalyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013, shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              (a)

                              the risk to re-entry workers;

                              (b)

                              the risk to groundwater when the substance is applied in regions with vulnerable soils and/or climatic conditions;

                              (c)

                              the risk to birds, mammals and aquatic organisms.

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

                              (1)

                              the toxicological and ecotoxicological information to address the relevance of impurities 4, 13, 16, 22 and 23;

                              (2)

                              the relevance of the metabolite HTFP and, concerning that metabolite, the groundwater risk assessment for all uses on crops in greenhouse;

                              (3)

                              the risk to aquatic invertebrates.

                        The applicant shall submit to the Commission, the Member States and the Authority the relevant information as regards point (1) by 31 December 2014 and information as regards point (2) and (3) by 30 June 2016.
                  The applicant shall present to the Commission, the Member States and the Authority a monitoring programme to assess the potential groundwater contamination from the metabolite HTFP in vulnerable zones, by 30 June 2016. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State, the Commission and the Authority by 30 June 2018.

         (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

                     ‘64

                     Pyridalyl
                     CAS No 179101-81-6
                     CIPAC No 792

                     2,6-dichloro-4-(3,3-dichloroallyloxy)phenyl 3-[5-(trifluoromethyl)-2-pyridyloxy]propyl ether

                     ≥ 910 g/kg

                     1 July 2014

                     30 June 2024

                     PART A
                     Only uses in greenhouses with permanent structure 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 pyridalyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013, shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 (a)

                                 the risk to re-entry workers;

                                 (b)

                                 the risk to groundwater when the substance is applied in regions with vulnerable soils and/or climatic conditions;

                                 (c)

                                 the risk to birds, mammals and aquatic organisms.

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

                                 (1)

                                 the toxicological and ecotoxicological information to address the relevance of impurities 4, 13, 16, 22 and 23;

                                 (2)

                                 the relevance of the metabolite HTFP and, concerning that metabolite, the groundwater risk assessment for all uses on crops in greenhouse;

                                 (3)

                                 the risk to aquatic invertebrates.

                           The applicant shall submit to the Commission, the Member States and the Authority the relevant information as regards point (1) by 31 December 2014 and information as regards point (2) and (3) by 30 June 2016.
                     The applicant shall present to the Commission, the Member States and the Authority a monitoring programme to assess the potential groundwater contamination from the metabolite HTFP in vulnerable zones by 30 June 2016. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State, the Commission and the Authority by 30 June 2018.’

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


title: Commission Implementing Regulation (EU) No 829/2013 of 29 August 2013 approving the active substance Pseudomonas sp. strain DSMZ 13134, 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:
               30.8.2013

               EN

               Official Journal of the European Union

               L 232/29

         COMMISSION IMPLEMENTING REGULATION (EU) No 829/2013
   of 29 August 2013
   approving the active substance Pseudomonas sp. strain DSMZ 13134, 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 Pseudomonas sp. strain DSMZ 13134 the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2008/599/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the Netherlands received on 28 August 2007 an application from Sourcon-Padena GmbH & Co. KG for the inclusion of the active substance Pseudomonas sp. strain DSMZ 13134 in Annex I to Directive 91/414/EEC. Decision 2008/599/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 3 November 2009.

               (4)

               The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion (4) on the pesticide risk assessment of the active substance Pseudomonas sp. strain DSMZ 13134 on 12 November 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 finalised on 16 July 2013 in the format of the Commission review report for Pseudomonas sp. strain DSMZ 13134.

               (5)

               It has appeared from the various examinations made that plant protection products containing Pseudomonas sp. strain DSMZ 13134 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 Pseudomonas sp. strain DSMZ 13134.

               (6)

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

               (7)

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

               (8)

               Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing Pseudomonas sp. strain DSMZ 13134. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

               (9)

               The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (5) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

               (10)

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

               (11)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of active substance
   The active substance Pseudomonas sp. strain DSMZ 13134, 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 Pseudomonas sp. strain DSMZ 13134 as an active substance by 31 July 2014.
   By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing Pseudomonas sp. strain DSMZ 13134 as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 January 2014 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
   Following that determination Member States shall:

               (a)

               in the case of a product containing Pseudomonas sp. strain DSMZ 13134 as the only active substance, where necessary, amend or withdraw the authorisation by 31 July 2015 at the latest; or

               (b)

               in the case of a product containing Pseudomonas sp. strain DSMZ 13134 as one of several active substances, where necessary, amend or withdraw the authorisation by 31 July 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

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

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 29 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 193, 22.7.2008, p. 14.

      (4)  EFSA Journal 2012; 10(12):2954. 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

                     Pseudomonas sp. strain DSMZ 13134
                  Collection number: DSMZ 13134

                  Not applicable

                  Minimum concentration: 3 × 1014 cfu/kg

                  1 February 2014

                  31 January 2024

                  For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Pseudomonas sp. strain DSMZ 13134, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Pseudomonas sp. strain DSMZ 13134 is to be considered as a potential sensitizer.
                  Conditions of use shall include risk mitigation measures, where appropriate.
                  The applicant shall submit information to confirm the absence of an acute intratracheal and intraperitoneal toxicity/infectivity/pathogenicity potential.
                  The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016.

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

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

                     Number

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘50

                        Pseudomonas sp. strain DSMZ 13134
                     Collection number: DSMZ 13134

                     Not applicable

                     Minimum concentration: 3×1014 cfu/kg

                     1 February 2014

                     31 January 2024

                     For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Pseudomonas sp. strain DSMZ 13134, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Pseudomonas sp. strain DSMZ 13134 is to be considered as a potential sensitizer.
                     Conditions of use shall include risk mitigation measures, where appropriate.
                     The applicant shall submit information to confirm the absence of an acute intratracheal and intraperitoneal toxicity/infectivity/pathogenicity potential.
                     The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016.’

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


title: Commission Implementing Regulation (EU) No 375/2013 of 23 April 2013 approving the active substance spiromesifen, 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 112/15

         COMMISSION IMPLEMENTING REGULATION (EU) No 375/2013
   of 23 April 2013
   approving the active substance spiromesifen, 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)(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 spiromesifen the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2003/105/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 18 April 2002 an application from Bayer CropScience AG for the inclusion of the active substance spiromesifen in Annex I to Directive 91/414/EEC. Decision 2003/105/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 9 March 2004. This draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’) and a final discussion took place on 26 April 2007. The Authority presented to the Commission its conclusion (4) on the review of the pesticide risk assessment of the active substance spiromesifen on 13 June 2007.

               (4)

               In its conclusion, the Authority did not take into account all information submitted by the applicant before 26 April 2007. The Commission requested the Authority to revise its conclusion and to take into account all information submitted.

               (5)

               The designated rapporteur Member State assessed all additional information and submitted an Addendum to the draft assessment report on 28 September 2009.

               (6)

               The Addendum to the draft assessment report was reviewed by the Member States and the Authority. The Authority presented to the Commission its second conclusion on the review of the pesticide risk assessment of the active substance spiromesifen (5) on 19 September 2012. The updated draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and the draft assessment report was finalised on 15 March 2013 in the format of the Commission review report for spiromesifen.

               (7)

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

               (8)

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

               (9)

               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.

               (10)

               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 spiromesifen. 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.

               (11)

               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 (6) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

               (12)

               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 (7) should be amended accordingly.

               (13)

               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 spiromesifen, 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 spiromesifen 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 spiromesifen 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 spiromesifen 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 spiromesifen 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 43, 18.2.2003, p. 45.

      (4)  EFSA Scientific Report (2007) 105, 1-69. Available online: www.efsa.europa.eu

      (5)  EFSA Journal 2012; 10(10):2873. Available online: www.efsa.europa.eu

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

      (7)  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

                  Spiromesifen
                  CAS No 283594-90-1
                  CIPAC No 747

                  3-mesityl-2-oxo-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutyrate

                  ≥ 965 g/kg (racemic)
                  The impurity N,N-dimethylacetamide is of toxicological relevance and must not exceed 4 g/kg in the technical material.

                  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 spiromesifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              —

                              the long-term risk to aquatic invertebrates,

                              —

                              the risk to pollinating hymenoptera and non-target arthropods if exposure is not negligible,

                              —

                              the protection of workers and operators.

                        Conditions of use shall include risk mitigation measures, where appropriate.
                  The applicant shall submit confirmatory information as regards the recalculation of the predicted concentration in groundwater (PECGW) with a FOCUS GW scenario adapted to the supported uses using a Q10 value of 2,58.
                  The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.

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

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

                     Number

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘41

                     Spiromesifen
                     CAS No 283594-90-1
                     CIPAC No 747

                     3-mesityl-2-oxo-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutyrate

                     ≥ 965 g/kg (racemic)
                     The impurity N,N-dimethylacetamide is of toxicological relevance and must not exceed 4 g/kg in the technical material.

                     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 spiromesifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 —

                                 the long-term risk to aquatic invertebrates,

                                 —

                                 the risk to pollinating hymenoptera and non-target arthropods if exposure is not negligible,

                                 —

                                 the protection of workers and operators.

                           Conditions of use shall include risk mitigation measures, where appropriate.
                     The applicant shall submit confirmatory information as regards the recalculation of the predicted concentration in groundwater (PECGW) with a FOCUS GW scenario adapted to the supported uses using a Q10 value of 2,58.
                     The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.’

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


title: Commission Implementing Regulation (EU) No 367/2013 of 22 April 2013 approving the active substance Spodoptera littoralis nucleopolyhedrovirus , 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:
                  23.4.2013

                  EN

                  Official Journal of the European Union

                  L 111/33

         COMMISSION IMPLEMENTING REGULATION (EU) No 367/2013
         of 22 April 2013
         approving the active substance Spodoptera littoralis nucleopolyhedrovirus, 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 Spodoptera littoralis nucleopolyhedrovirus the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2007/669/EC (3).

                     (2)

                     In accordance with Article 6(2) of Directive 91/414/EEC Estonia received on 2 January 2007 an application from Andermatt Biocontrol GmbH for the inclusion of the active substance Spodoptera littoralis nucleopolyhedrovirus in Annex I to Directive 91/414/EEC. Decision 2007/669/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 26 March 2009.

                     (4)

                     The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the review of the pesticide risk assessment of the active substance Spodoptera littoralis nucleopolyhedrovirus (4) on 10 August 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 Spodoptera littoralis nucleopolyhedrovirus.

                     (5)

                     It has appeared from the various examinations made that plant protection products containing Spodoptera littoralis nucleopolyhedrovirus 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 Spodoptera littoralis nucleopolyhedrovirus.

                     (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 Spodoptera littoralis nucleopolyhedrovirus. 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 Spodoptera littoralis nucleopolyhedrovirus, 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 Spodoptera littoralis nucleopolyhedrovirus as an active substance by 30 November 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 Spodoptera littoralis nucleopolyhedrovirus 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 May 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 Spodoptera littoralis nucleopolyhedrovirus as the only active substance, where necessary, amend or withdraw the authorisation by 30 November 2014 at the latest; or

                           (b)

                           in the case of a product containing Spodoptera littoralis nucleopolyhedrovirus as one of several active substances, where necessary, amend or withdraw the authorisation by 30 November 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 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 June 2013.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 22 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 274, 18.10.2007, p. 15.

            (4)  EFSA Journal 2012; 10(9):2864. 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

                           Spodoptera littoralis nucleopolyhedrovirus

                        DSMZ number: BV-0005

                        Not applicable

                        Maximum concentration: 1 × 1012 OB/l (occlusion bodies/l)

                        1 June 2013

                        31 May 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 Spodoptera littoralis nucleopolyhedrovirus, and in particular Appendices I and II thereof, 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

                           ‘42

                              Spodoptera littoralis nucleopolyhedrovirus

                           DSMZ number: BV-0005

                           Not applicable

                           Maximum concentration: 1 × 1012 OB/l (occlusion bodies/l)

                           1 June 2013

                           31 May 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 Spodoptera littoralis nucleopolyhedrovirus, and in particular Appendices I and II thereof, 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 149/2014 of 17 February 2014 approving the active substance L-ascorbic acid, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011  Text with EEA relevance

text:
               18.2.2014

               EN

               Official Journal of the European Union

               L 46/3

      COMMISSION IMPLEMENTING REGULATION (EU) No 149/2014
   of 17 February 2014
   approving the active substance L-ascorbic acid, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) and Article 78(2) thereof,
   Whereas:

               (1)

               In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, 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 L-ascorbic acid, initially referred to as 'ascorbic acid', the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2005/751/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the Netherlands received on 14 September 2004 an application from Citrex Europe B.V. for the inclusion of the active substance L-ascorbic acid in Annex I to Directive 91/414/EEC. Decision 2005/751/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 10 September 2007. In accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 (4) additional information was requested from the applicant on 17 May 2011. The evaluation of the additional data by the Netherlands was submitted in the format of an updated draft assessment report in July 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 pesticide risk assessment of the active substance L-ascorbic acid (5) on 17 April 2013. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 13 December 2013 in the format of the Commission review report for L-ascorbic acid.

               (5)

               It has appeared from the various examinations made that plant protection products containing L-ascorbic acid 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 L-ascorbic acid.

               (6)

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

               (7)

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

               (8)

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

               (9)

               The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (6) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

               (10)

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

               (11)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of active substance
   The active substance L-ascorbic acid, 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 L-ascorbic acid as an active substance by 31 December 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 L-ascorbic acid 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 June 2014 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
   Following that determination Member States shall:

               (a)

               in the case of a product containing L-ascorbic acid 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 L-ascorbic acid 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 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 July 2014.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 17 February 2014.

            For the Commission

            The President

         José Manuel BARROSO

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

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

      (3)  Commission Decision 2005/751/EC of 21 October 2005 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of ascorbic acid, potassium iodide and potassium thiocyanate in Annex I to Council Directive 91/414/EEC (OJ L 282, 26.10.2005, p. 18).

      (4)  Commission Regulation (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive (OJ L 53, 26.2.2011, p. 51).

      (5)  EFSA Journal 2013; 11(4):3197. Available online: www.efsa.europa.eu

      (6)  Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (OJ L 366, 15.12.1992, p. 10).

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

      ANNEX I

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  L-ascorbic acid
                  CAS No 50-81-7
                  CIPAC No 774

                  (5R)-5-[(1S)-1,2-dihydroxyethyl]-3,4-dihydroxyfuran-2(5H)-one

                  ≥ 990 g/kg
                  The following relevant impurities shall not exceed:
                  Methanol: ≤ 3 g/kg
                  Heavy Metals: ≤ 10 mg/kg (expressed as Pb)

                  1 July 2014

                  30 June 2024

                  For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on L-ascorbic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              (a)

                              the risk to aquatic and soil organisms;

                              (b)

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

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

                              (1)

                              the natural background of L-ascorbic acid in the environment confirming a low chronic risk for fish and a low risk for aquatic invertebrates, algae, earthworms and soil microorganisms;

                              (2)

                              the risk to contaminate groundwater.

                        The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.

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

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

                     Number

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘66

                     L-ascorbic acid
                     CAS No 50-81-7
                     CIPAC No 774

                     (5R)-5-[(1S)-1,2-dihydroxyethyl]-3,4-dihydroxyfuran-2(5H)-one

                     ≥ 990 g/kg
                     The following relevant impurities shall not exceed:
                     Methanol: ≤ 3 g/kg
                     Heavy Metals: ≤ 10 mg/kg (expressed as Pb)

                     1 July 2014

                     30 June 2024

                     For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on L-ascorbic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 (a)

                                 the risk to aquatic and soil organisms;

                                 (b)

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

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

                                 (1)

                                 the natural background of L-ascorbic acid in the environment confirming a low chronic risk for fish and a low risk for aquatic invertebrates, algae, earthworms and soil microorganisms;

                                 (2)

                                 the risk to contaminate groundwater.

                           The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.’

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