title: Commission Implementing Regulation (EU) No 922/2014 of 25 August 2014 approving the active substance metaflumizone, 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:
               26.8.2014

               EN

               Official Journal of the European Union

               L 252/6

         COMMISSION IMPLEMENTING REGULATION (EU) No 922/2014
   of 25 August 2014
   approving the active substance metaflumizone, 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 metaflumizone the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2006/517/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 29 March 2005 an application from BASF SE. for the inclusion of the active substance metaflumizone in Annex I to Directive 91/414/EEC. Decision 2006/517/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 29 March 2005. In accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 (4) additional information was requested from the applicant on 5 July 2011. The evaluation of the additional data by the United Kingdom was submitted in the format of an updated draft assessment report on 8 June 2012.

               (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 metaflumizone (5) on 13 September 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 within the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 in the format of the Commission review report for metaflumizone.

               (5)

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

               (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 metaflumizone. 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 Plants, Animals, Food and Feed,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of active substance
   The active substance metaflumizone, 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 metaflumizone as an active substance by 30 June 2015.
   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 metaflumizone 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 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 metaflumizone as the only active substance, where necessary, amend or withdraw the authorisation by 30 June 2016 at the latest; or

               (b)

               in the case of a product containing metaflumizone as one of several active substances, where necessary, amend or withdraw the authorisation by 30 June 2016 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 January 2015.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 25 August 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 2006/517/EC of 19 July 2006 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of metaflumizone in Annex I to Council Directive 91/414/EEC (OJ L 201, 25.7.2006, p. 34).

      (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(10):3373. Available online: www.efsa.europa.eu

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

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

      ANNEX I

                  Common name, identification numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  Metaflumizone
                  CAS No 139968-49-3
                  CIPAC No 779

                  (EZ)-2′-[2-(4-cyanophenyl)-1-(α,α,α-trifluoro-m-tolyl)ethylidene]-4-(trifluoromethoxy)carbanilohydrazide

                  ≥ 945 g/kg
                  (90-100 % E-isomer
                  10-0 % Z-isomer)
                  The following relevant impurities shall not exceed a certain threshold:

                              Hydrazine ≤ 1 mg/kg

                              4-(trifluoromethoxy)phenyl isocyanate ≤ 100 mg/kg

                              Toluene ≤ 2 g/kg

                  1 January 2015

                  31 December 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 metaflumizone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              (a)

                              the risk to fish and sediment dwelling organisms;

                              (b)

                              the risk to snail- or earthworm-eating birds.

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

                              (1)

                              the equivalence of the material used in the toxicological and ecotoxicological studies with the proposed technical specification;

                              (2)

                              information addressing the potential of metaflumizone for bioaccumulation in aquatic organisms and biomagnification in aquatic food chains.

                        The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under (1) by 30 June 2015 and under (2) by 31 December 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

                     ‘78

                     Metaflumizone
                     CAS No 139968-49-3
                     CIPAC No 779

                     (EZ)-2′-[2-(4-cyanophenyl)-1-(α,α,α-trifluoro-m-tolyl)ethylidene]-4-(trifluoromethoxy)carbanilohydrazide

                     ≥ 945 g/kg
                     (90-100 % E-isomer
                     10-0 % Z-isomer)
                     The following relevant impurities shall not exceed a certain threshold:

                                 Hydrazine ≤ 1 mg/kg

                                 4-(trifluoromethoxy)phenyl isocyanate ≤ 100 mg/kg

                                 Toluene ≤ 2 g/kg

                     1 January 2015

                     31 December 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 metaflumizone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 (a)

                                 the risk to fish and sediment dwelling organisms;

                                 (b)

                                 the risk to snail- or earthworm-eating birds.

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

                                 (1)

                                 the equivalence of the material used in the toxicological and ecotoxicological studies with the proposed technical specification;

                                 (2)

                                 information addressing the potential of metaflumizone for bioaccumulation in aquatic organisms and biomagnification in aquatic food chains.

                           The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under (1) by 30 June 2015 and under (2) by 31 December 2016.’

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


title: Commission Implementing Regulation (EU) No 797/2011 of 9 August 2011 approving the active substance spiroxamine, 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:
               10.8.2011

               EN

               Official Journal of the European Union

               L 205/3

         COMMISSION IMPLEMENTING REGULATION (EU) No 797/2011
   of 9 August 2011
   approving the active substance spiroxamine, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) and Article 78(2) thereof,
   Whereas:

               (1)

               In accordance with Article 80(1)(b) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply to active substances listed in Annex I to Commission Regulation (EC) No 737/2007 of 27 June 2007 on laying down the procedure of the renewal of the inclusion of a first group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances (3), with respect to the procedure and the conditions for approval. Spiroxamine is listed in Annex I to Regulation (EC) No 737/2007.

               (2)

               The approval of spiroxamine, 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 spiroxamine 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, prohexadion-calcium and spiroxamine, and establishing the list of the notifiers concerned (5).

               (4)

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

               (5)

               The rapporteur Member State prepared an assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 17 September 2009. In addition to the assessment of the active substance, that report includes a list of the studies the rapporteur Member State relied on for its assessment.

               (6)

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

               (7)

               At the request of the Commission, the assessment report was peer reviewed by the Member States and the Authority. The Authority presented its conclusion on the peer review of the risk assessment of spiroxamine (6) to the Commission on 1 September 2010. 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 spiroxamine.

               (8)

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

               (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 spiroxamine 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 six months after approval to review authorisations of plant protection products containing spiroxamine. 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 spiroxamine, 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 spiroxamine 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 spiroxamine 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 spiroxamine 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 spiroxamine 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, 9 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)  Conclusion on the peer review of the pesticide risk assessment of the active substance spiroxamine. EFSA Journal 2010; 8(9)1719 [102 pp.], doi:10.2903/j.efsa.2010 1719. Available online: www.efsa.europa.eu

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

      ANNEX I

                  Common name, identification numbers

                  IUPAC name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  Spiroxamine
                  CAS No 1181134-30-8
                  CIPAC No 572

                  8-tert-butyl-1,4-dioxaspiro[4.5]decan-2-
                  ylmethyl(ethyl)(propyl)amine (ISO)

                  ≥ 940 g/kg
                  (diastereomers A and B combined)

                  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 spiroxamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              (1)

                              the risk to operators and workers and ensure that conditions of use include the application of adequate personal protective equipment;

                              (2)

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

                              (3)

                              the risk to aquatic organisms.

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

                              (a)

                              the possible impact on the worker, the consumer and the environmental risk assessment of the potential stereo-selective degradation of each isomer in plant, animals and the environment;

                              (b)

                              the toxicity of the plant metabolites formed in fruit crops and the potential hydrolysis of fruit crop residues in processed commodities;

                              (c)

                              the groundwater exposure assessment for metabolite M03 (2);

                              (d)

                              the risk to aquatic organisms.

                        The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by two years after the adoption of specific guidance and the information set out in points (b), (c) and (d) by 31 December 2013.

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

         (2)  M03: [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide.

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

                  (1)

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

                  (2)

                  in Part B, the following entry is added:

                              ‘7

                              Spiroxamine
                              CAS No 1181134-30-8
                              CIPAC No 572

                              8-tert-butyl-1,4-dioxaspiro[4.5]decan-2-ylmethyl(ethyl)(propyl)amine (ISO)

                              ≥ 940 g/kg
                              (diastereomers A and B combined)

                              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 spiroxamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.
                              In this overall assessment Member States shall pay particular attention to:

                                          (1)

                                          the risk to operators and workers and ensure that conditions of use include the application of adequate personal protective equipment;

                                          (2)

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

                                          (3)

                                          the risk to aquatic organisms.

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

                                          (a)

                                          the possible impact on the worker, the consumer and the environmental risk assessment of the potential stereo-selective degradation of each isomer in plant, animals and the environment;

                                          (b)

                                          the toxicity of the plant metabolites formed in fruit crops and the potential hydrolysis of fruit crop residues in processed commodities;

                                          (c)

                                          the groundwater exposure assessment for metabolite M03 (1);

                                          (d)

                                          the risk to aquatic organisms.

                                    The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by two years after the adoption of specific guidance and the information set out in points (b), (c) and (d) by 31 December 2013.

         (1)  M03: [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide.’


title: Commission Implementing Regulation (EU) No 674/2011 of 13 July 2011 fixing an acceptance percentage for the issuing of export licences, rejecting export-licence applications and suspending the lodging of export-licence applications for out-of-quota sugar

text:
               14.7.2011

               EN

               Official Journal of the European Union

               L 184/4

         COMMISSION IMPLEMENTING REGULATION (EU) No 674/2011
   of 13 July 2011
   fixing an acceptance percentage for the issuing of export licences, rejecting export-licence applications and suspending the lodging of export-licence applications for out-of-quota sugar
   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 Regulation (EC) No 951/2006 of 30 June 2006 laying down detailed rules for the implementation of Council Regulation (EC) No 318/2006 as regards trade with third countries in the sugar sector (2), and in particular Article 7e in conjunction with Article 9(1) thereof,
   Whereas:

               (1)

               According to Article 61, first subparagraph, point (d) of Regulation (EC) No 1234/2007 the sugar produced during the marketing year in excess of the quota referred to in Article 56 of that Regulation may be exported only within the quantitative limit fixed by the Commission.

               (2)

               Commission Regulation (EU) No 397/2010 of 7 May 2010 fixing the quantitative limit for the exports of out-of-quota sugar and isoglucose until the end of the 2010/2011 marketing year (3) sets the above mentioned limits.

               (3)

               The quantities of sugar covered by applications for export licences exceed the quantitative limit fixed by Regulation (EU) No 397/2010. An acceptance percentage should therefore be set for quantities applied for on 4, 5, 6, 7 and 8 July 2011. All export-licence applications for sugar lodged after 8 July 2011 should accordingly be rejected and the lodging of export-licence applications should be suspended,

         HAS ADOPTED THIS REGULATION:
   Article 1
   1.   Export licences for out-of-quota sugar for which applications were lodged between 4 July and 8 July 2011 shall be issued for the quantities applied for, multiplied by an acceptance percentage of 71,122263 %.
   2.   Applications for out-of-quota sugar export licences submitted on 11, 12, 13, 14 and 15 July 2011 are hereby rejected.
   3.   The lodging of applications for out-of-quota sugar export licences shall be suspended for the period 18 July 2011 to 30 September 2011.
   Article 2
   This Regulation shall enter into force on the 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, 13 July 2011.

            For the Commission, On behalf of the President,

         José Manuel SILVA RODRÍGUEZ

            Director-General for Agriculture and Rural Development

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

      (2)  OJ L 178, 1.7.2006, p. 24.

      (3)  OJ L 115, 8.5.2010, p. 26.


title: Commission Implementing Regulation (EU) No 582/2012 of 2 July 2012 approving the active substance bifenthrin, 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:
               3.7.2012

               EN

               Official Journal of the European Union

               L 173/3

         COMMISSION IMPLEMENTING REGULATION (EU) No 582/2012
   of 2 July 2012
   approving the active substance bifenthrin, 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)(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 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (3), with respect to the procedure and the conditions for approval. Bifenthrin is an active substance for which completeness has been established in accordance with that Regulation.

               (2)

               Commission Regulations (EC) No 451/2000 (4) and (EC) No 1490/2002 (5) lay down the detailed rules for the implementation of the second and third stages of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included bifenthrin. By Commission Decision 2009/887/EC (6) it was decided not to include bifenthrin 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 accelerated procedure to be applied, as provided for in Articles 14 to 19 of Regulation (EC) No 33/2008.

               (4)

               The application was submitted to France, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2009/887/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

               (5)

               France evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 6 August 2010. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on bifenthrin to the Commission on 11 May 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 1 June 2012 in the format of the Commission review report for bifenthrin.

               (6)

               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 the potential contamination of groundwater by a major soil degradation product (TFP acid), a possible underestimation of the risk to consumers, due to the limited number of residue data made available and the lack of investigation on the metabolism pattern of the two isomers constituting bifenthrin. As regards ecotoxicology, the risk for mammals, aquatic organisms, earthworms, non-target arthropods, non-target plants and non-target soil macro-organisms had not been sufficiently addressed.

               (7)

               The new information submitted by the applicant shows that the potential contamination of groundwater by bifenthrin and its metabolites, including TFP acid, is low. Adequate residue data and information as regards the metabolisation of the isomers have been submitted and confirm an acceptable risk for consumers. As regards ecotoxicology, the refined risk assessment for mammals, aquatic organisms, earthworms, non-target arthropods, non-target macro-organisms and non-target plants permitted to identify acceptable risk scenarios for the concerned species.

               (8)

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

               (9)

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

               (10)

               The acceptable risk scenarios as regards ecotoxicology notwithstanding, the risk assessment revealed that bifenthrin has a potential to show bioaccumulation effects. The approval period should therefore be seven years rather than the possible maximum of 10 years.

               (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 bifenthrin 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 bifenthrin, 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 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, 2 July 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 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 318, 4.12.2009, p. 41.

      (7)  European Food Safety Authority; ‘Conclusion on the peer review of the pesticide risk assessment of the active substance bifenthrin’. EFSA Journal 2011;9(5):2159. 0;8(11): [101 pp.] doi:10.2903/j.efsa.2011.2159. 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

                  Bifenthrin
                  CAS No 82657-04-3
                  CIPAC No 415

                  2-methylbiphenyl-3-ylmethyl (1RS,3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate
                  or
                  2-methylbiphenyl-3-ylmethyl (1RS)-cis-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate

                  ≥ 930 g/kg
                  Impurities:
                  Toluene: not more than 5 g/kg

                  1 August 2012

                  31 July 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 bifenthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              (a)

                              the persistency in the environment;

                              (b)

                              the risk for bioaccumulation and biomagnification;

                              (c)

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

                              (d)

                              the risk to aquatic organisms, in particular fish and invertebrates, non-target arthropods and bees, ensuring that conditions of authorisation include risk mitigation measures, where appropriate.

                        The applicant shall submit confirmatory information as regards:

                              (1)

                              the residual toxicity for non-target arthropods and the potential for recolonisation;

                              (2)

                              the fate and behaviour of soil metabolite 4'-OH bifenthrin;

                              (3)

                              the degradation in soil of the isomers which constitute bifenthrin, 4'-OH bifenthrin and TFP acid.

                        The applicant shall submit to the Commission, the Member States and the Authority the information set out in points 1, 2 and 3 by 31 July 2014.
                  The applicant shall present to the Commission, the Member States and the Authority a monitoring programme to assess the potential for bioaccumulation and biomagnification in the aquatic and terrestrial environment by 31 July 2013. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State, the Commission and the Authority by 31 July 2015.

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

      ANNEX II
      In Part B of the Annex to Implementing Regulation (EU) 540/2011, the following entry is added:

                     No

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘23

                     Bifenthrin
                     CAS No
                     82657-04-3
                     CIPAC No 415

                     2-methylbiphenyl-3-ylmethyl (1RS,3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate
                     or
                     2-methylbiphenyl-3-ylmethyl (1RS)-cis-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate

                     ≥ 930 g/kg
                     Impurities:
                     Toluene: not more than 5 g/kg

                     1 August 2012

                     31 July 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 bifenthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 (a)

                                 the persistency in the environment;

                                 (b)

                                 the risk for bioaccumulation and biomagnification;

                                 (c)

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

                                 (d)

                                 the risk to aquatic organisms, in particular fish and invertebrates, non-target arthropods and bees, ensuring that conditions of authorisation include risk mitigation measures, where appropriate.

                           The applicant shall submit confirmatory information as regards:

                                 (1)

                                 the residual toxicity for non-target arthropods and the potential for recolonisation;

                                 (2)

                                 the fate and behaviour of soil metabolite 4'-OH bifenthrin;

                                 (3)

                                 the degradation in soil of the isomers which constitute bifenthrin, 4'-OH bifenthrin and TFP acid.

                           The applicant shall submit to the Commission, the Member States and the Authority the information set out in points 1, 2 and 3 by 31 July 2014.
                     The applicant shall present to the Commission, the Member States and the Authority a monitoring programme to assess the potential for bioaccumulation and biomagnification in the aquatic and terrestrial environment by 31 July 2013. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State, the Commission and the Authority by 31 July 2015.’

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


title: Commission Implementing Regulation (EU) 2015/51 of 14 January 2015 approving the active substance chromafenozide, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and allowing Member States to extend provisional authorisations granted for that active substance  Text with EEA relevance

text:
               15.1.2015

               EN

               Official Journal of the European Union

               L 9/22

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/51
   of 14 January 2015
   approving the active substance chromafenozide, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and allowing Member States to extend provisional authorisations granted for that active substance
   (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 chromafenozide the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2006/586/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC Hungary received on 12 December 2004 an application from Arysta LifeScience (formerly Calliope SAS) on behalf of Nippon Kayaku for the inclusion of the active substance chromafenozide in Annex I to Directive 91/414/EEC. Decision 2006/586/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 19 March 2012.

               (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 chromafenozide (4) on 31 October 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 Plants, Animals, Food and Feed and finalised on 10 October 2014 in the format of the Commission review report for chromafenozide.

               (5)

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

               (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 chromafenozide. 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)

               It is also appropriate to allow Member States to extend provisional authorisations granted for plant protection products containing chromafenozide in order to provide them with the time necessary to fulfil the obligations set out in this Regulation as regards those provisional authorisations.

               (12)

               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of active substance
   The active substance chromafenozide, 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 chromafenozide as an active substance by 30 September 2015.
   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 chromafenozide 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 2015 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 chromafenozide as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2016 at the latest; or

               (b)

               in the case of a product containing chromafenozide as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2016 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
   Extension of existing provisional authorisations
   Member States may extend existing provisional authorisations for plant protection products containing chromafenozide for a period ending on 30 September 2016 at the latest.
   Article 5
   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 2015.
   However, Article 4 shall apply from the date of the entry into force of this Regulation.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 14 January 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (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 2006/586/EC of 25 August 2006 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of chromafenozide, halosulfuron, tembotrione, valiphenal and Zucchini yellow mosaic virus — weak strain in Annex I to Council Directive 91/414/EEC (OJ L 236, 31.8.2006, p. 31).

      (4)  EFSA Journal 2013;11(12):3461. 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 (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

                  Chromafenozide
                  CAS No 143807-66-3
                  CIPAC No 775

                     N′-tert-butyl-5-methyl-N′-(3,5-xyloyl)chromane-6-carbohydrazide

                  ≥ 935 g/kg
                  The following relevant impurity must not exceed a certain threshold in the technical material:
                  Butyl acetate (n-buthyl acetate, CAS No 123-86-4): ≤ 8 g/kg

                  1 April 2015

                  31 March 2025

                  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 chromafenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014, shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              (a)

                              the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions;

                              (b)

                              the risk to non-target Lepidoptera in off-crop areas;

                              (c)

                              the risk to sediment-dwelling organisms.

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

                              (1)

                              the non-significance of the difference between the material used for ecotoxicological testing and the agreed specification of the technical material for the risk assessment;

                              (2)

                              the assessment of the risk to sediment dwelling organisms from metabolite M-010;

                              (3)

                              the leaching potential of metabolites M-006 and M-023 to groundwater.

                        The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under (1) by 30 September 2015 and under (2) and (3) by 31 March 2017.

         (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

                     ‘81

                     Chromafenozide
                     CAS No 143807-66-3
                     CIPAC No 775

                        N′-tert-butyl-5-methyl-N′-(3,5-xyloyl)chromane-6-carbohydrazide

                     ≥ 935 g/kg
                     The following relevant impurity must not exceed a certain threshold in the technical material:
                     Butyl acetate (n-buthyl acetate, CAS No 123-86-4): ≤ 8 g/kg

                     1 April 2015

                     31 March 2025

                     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 chromafenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014, shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 (a)

                                 the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions;

                                 (b)

                                 the risk to non-target Lepidoptera in off-crop areas;

                                 (c)

                                 the risk to sediment-dwelling organisms.

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

                                 (1)

                                 the non-significance of the difference between the material used for ecotoxicological testing and the agreed specification of the technical material for the risk assessment;

                                 (2)

                                 the assessment of the risk to sediment dwelling organisms from metabolite M-010;

                                 (3)

                                 the leaching potential of metabolites M-006 and M-023 to groundwater.

                           The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under (1) by 30 September 2015 and under (2) and (3) by 31 March 2017.’

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


title: Commission Implementing Regulation (EU) No 487/2014 of 12 May 2014 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713, clodinafop, metrafenone, pirimicarb, rimsulfuron, spinosad, thiamethoxam, tolclofos-methyl and triticonazole  Text with EEA relevance

text:
               13.5.2014

               EN

               Official Journal of the European Union

               L 138/72

         COMMISSION IMPLEMENTING REGULATION (EU) No 487/2014
   of 12 May 2014
   amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713, clodinafop, metrafenone, pirimicarb, rimsulfuron, spinosad, thiamethoxam, tolclofos-methyl and triticonazole
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the first paragraph of Article 17 thereof,
   Whereas:

               (1)

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

               (2)

               The approvals of the active substances Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713, clodinafop, metrafenone, pirimicarb, rimsulfuron, spinosad, thiamethoxam, tolclofos-methyl and triticonazole will expire on 31 January 2017. Applications have been submitted for the renewal of the approval of these active substances. As the requirements laid down in Commission Implementing Regulation (EU) No 844/2012 (3) apply to those active substances, it is necessary to allow applicants sufficient time to complete the renewal procedure in accordance with that Regulation. Consequently, the approvals of those active substances are likely to expire before a decision has been taken on their renewal. It is therefore necessary to extend their approval periods.

               (3)

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

               (4)

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

               (5)

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

               (6)

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

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

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 12 May 2014.

            For the Commission

            The President

         José Manuel BARROSO

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

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

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

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

                  (1)

                  In the sixth column, expiration of approval, of row 123, clodinafop, the date ‘31 January 2017’ is replaced by ‘30 April 2018’;

                  (2)

                  In the sixth column, expiration of approval, of row 124, pirimicarb, the date ‘31 January 2017’ is replaced by ‘30 April 2018’;

                  (3)

                  In the sixth column, expiration of approval, of row 125, rimsulfuron, the date ‘31 January 2017’ is replaced by ‘30 April 2018’;

                  (4)

                  In the sixth column, expiration of approval, of row 126, tolclofos-methyl, the date ‘31 January 2017’ is replaced by ‘30 April 2018’;

                  (5)

                  In the sixth column, expiration of approval, of row 127, triticonazole, the date ‘31 January 2017’ is replaced by ‘30 April 2018’;

                  (6)

                  In the sixth column, expiration of approval, of row 137, metrafenone, the date ‘31 January 2017’ is replaced by ‘30 April 2018’;

                  (7)

                  In the sixth column, expiration of approval, of row 138, Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713, the date ‘31 January 2017’ is replaced by ‘30 April 2018’;

                  (8)

                  In the sixth column, expiration of approval, of row 139, spinosad, the date ‘31 January 2017’ is replaced by ‘30 April 2018’;

                  (9)

                  In the sixth column, expiration of approval, of row 140, thiamethoxam, the date ‘31 January 2017’ is replaced by ‘30 April 2018’.


title: Commission Implementing Regulation (EU) No 462/2014 of 5 May 2014 approving the basic substance Equisetum arvense L., 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 Implementing Regulation (EU) No 540/2011  Text with EEA relevance

text:
               7.5.2014

               EN

               Official Journal of the European Union

               L 134/28

         COMMISSION IMPLEMENTING REGULATION (EU) No 462/2014
   of 5 May 2014
   approving the basic substance Equisetum arvense L., 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 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 23(5) in conjunction with Article 13(2) and Article 78(2) thereof,
   Whereas:

               (1)

               In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 28 December 2011 an application from Institut Technique de l'Agriculture Biologique (ITAB) for the approval of Equisetum arvense L. as basic substance. That application was accompanied by the information required by the second subparagraph of Article 23(3).

               (2)

               The Commission asked the European Food Safety Authority (hereinafter ‘the Authority’) for scientific assistance. The Authority presented to the Commission a Technical report on the substance concerned on 24 May 2013 (2). The Commission presented the review report and this draft regulation on the approval of Equisetum arvense L. to the Standing Committee on the Food Chain and Animal Health on 20 March 2014.

               (3)

               The documentation provided by the applicant and the results of examination carried out by the Authority (3) in accordance with Regulation (EC) No 1924/2006 of the European Parliament and of the Council (4) show that Equisetum arvense L. fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (5). Moreover, it is not predominantly used for plant protection purposes but nevertheless is useful in plant protection in a product consisting of the substance and water. Consequently, it is to be considered as a basic substance.

               (4)

               As the basic substance concerned is a foodstuff not requiring a specific authorisation under Regulation (EC) No 178/2002, it is deemed to be evaluated as having neither an immediate or delayed harmful effect on human or animal health nor an unacceptable effect on the environment.

               (5)

               It has appeared from the examinations made that Equisetum arvense L. may be expected to satisfy, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the uses which were examined and detailed in the Commission review report. 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 include certain conditions for the approval which are detailed in Annex I to this Regulation.

               (6)

               In accordance with Article 23(5) of Regulation (EC) No 1107/2009, basic substances are to be listed separately in the Regulation referred to in Article 13(4) of Regulation (EC) No 1107/2009. It is therefore appropriate to add a Part C in the Annex to Commission Implementing Regulation (EU) No 540/2011 (6). That Regulation 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
   Approval of a basic substance
   The basic substance Equisetum arvense L., 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
   (1)   In Article 1 of Regulation (EU) No 540/2011 the second paragraph is replaced by the following two paragraphs:

      ‘The active substances approved under Regulation (EC) No 1107/2009 are as set out in Part B of the Annex to this Regulation. The basic substances approved under Regulation (EC) No 1107/2009 are as set out in Part C of the Annex to this Regulation.’

   (2)   The Annex to 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 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, 5 May 2014.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  Outcome of the consultation with Member States and EFSA on the basic substance application for Equisetum arvense L. and the conclusions drawn by EFSA on the specific points raised. 2013:EN-427.23 pp.

      (3)  EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) EFSA Journal 2009; 7(9): 1289 doi: 10.2903/j.efsa.2009.1289.

      (4)  Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (OJ L 404, 30.12.2006, p. 9.).

      (5)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

      (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

                  Specific provisions

                     Equisetum arvense L.
                  CAS No: not allocated
                  CIPAC No: not allocated

                  Not applicable

                  European Pharmacopeia

                  1 July 2014

                     Equisetum arvense L. may be used in accordance with the specific conditions included in the conclusions of the review report on Equisetum arvense L. (SANCO/12386/2013) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014.

         (1)  Further details on identity, specification and manner of use of basic substance are provided in the review report.

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

                  (1)

                  The title of the Annex is replaced by the following:
                  ‘ANNEX ACTIVE SUBSTANCES’

                  (2)

                  The following Part C is added:
                  ‘PART C

                     Basic Substances

                  General provisions applying to all substances listed in this Part: the Commission shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or shall make them available to them on specific request.

                              Number

                              Common Name,
                              Identification Numbers

                              IUPAC Name

                              Purity (1)

                              Date of approval

                              Specific provisions

                              1

                                 Equisetum arvense L.
                              CAS No: not allocated
                              CIPAC No: not allocated

                              Not applicable

                              European Pharmacopeia

                              1 July 2014

                                 Equisetum arvense L. may be used in accordance with the specific conditions included in the conclusions of the review report on Equisetum arvense L. (SANCO/12386/2013) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014.

         (1)  Further details on identity, specification and manner of use of basic substance are provided in the review report.’