title: Commission Implementing Regulation (EU) No 1134/2011 of 9 November 2011 concerning the non-renewal of the approval of the active substance cinidon-ethyl, 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 Commission Implementing Regulation (EU) No 540/2011 Text with EEA relevance

text:
               10.11.2011

               EN

               Official Journal of the European Union

               L 292/1

         COMMISSION IMPLEMENTING REGULATION (EU) No 1134/2011
   of 9 November 2011
   concerning the non-renewal of the approval of the active substance cinidon-ethyl, 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 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 20 thereof,
   Whereas:

               (1)

               The active substance cinidon-ethyl was included in Annex I to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (2) for a period expiring on 30 September 2012.

               (2)

               To enable applicants to prepare their applications and to enable the Commission to evaluate and decide upon such applications, that inclusion was extended until 31 December 2015 by Commission Directive 2010/77/EU of 10 November 2010 amending Council Directive 91/414/EEC as regards the expiry dates for inclusion in Annex I of certain active substances (3).

               (3)

               In accordance with Article 78(3) of Regulation (EC) No 1107/2009 that substance was included 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) and is to be deemed to have been approved under Regulation (EC) No 1107/2009.

               (4)

               The Commission did not, however, receive any applications for the active substance concerned and the time period for the submission of such applications, as provided for in Article 4(1) of Commission Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances (5), has expired.

               (5)

               Consequently, the approval of that active substance should not be renewed and it should be removed from Part A of the Annex to Implementing Regulation (EU) No 540/2011, as from the date on which its approval would have expired had it not been extended by Directive 2010/77/EU.

               (6)

               This Regulation does not prejudice the submission of an application for this substance pursuant to Article 7 of Regulation (EC) No 1107/2009.

               (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
   Non-renewal of approval
   The approval of the active substance cinidon-ethyl is not renewed.
   Article 2
   Grace periods
   Any grace period granted by a Member State for plant protection products containing cinidon-ethyl shall expire on 31 March 2013 at the latest for the sale and distribution and on 31 March 2014 at the latest for the disposal, storage, and use of existing stocks.
   Article 3
   Amendments to Implementing Regulation (EU) No 540/2011
   Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
   Article 4
   Entry into force
   This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 9 November 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 293, 11.11.2010, p. 48.

      (4)  OJ L 153, 11.6.2011, p. 1.

      (5)  OJ L 322, 8.12.2010, p. 10.

      ANNEX
      In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 33 is replaced by the following:

                     Number

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘33

                     Cinidon-ethyl
                     CAS No 142891-20-1
                     CIPAC No 598

                     (Z)-ethyl 2-chloro-3-[2-chloro-5-(cyclohex-1-ene-1,2-dicarboximido)phenyl]acrylate

                     940 g/kg

                     1 October 2002

                     30 September 2012

                     Only uses as herbicide may be authorised.
                     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 cinidon-ethyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States:

                                 —

                                 should pay particular attention to the potential for ground water contamination, when the active substance is applied in regions with vulnerable soil (e.g. soils with neutral or high pH values) and/or climatic conditions,

                                 —

                                 should pay particular attention to the protection of aquatic organisms.

                           Conditions of authorisation must include risk mitigation measures, where appropriate.’

         (1)  Further details on identity and specification of active substances are provided in their review reports.


title: Commission Implementing Regulation (EU) No 905/2014 of 20 August 2014 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               21.8.2014

               EN

               Official Journal of the European Union

               L 246/26

         COMMISSION IMPLEMENTING REGULATION (EU) No 905/2014
   of 20 August 2014
   establishing the standard import values for determining the entry price of certain fruit and vegetables
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),
   Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
   Whereas:

               (1)

               Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

               (2)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 20 August 2014.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General for Agriculture and Rural Development

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

      (2)  OJ L 157, 15.6.2011, p. 1.

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

                  (EUR/100 kg)

                  CN code

                  Third country code (1)

                  Standard import value

                  0707 00 05

                  TR

                  81,4

                  ZZ

                  81,4

                  0709 93 10

                  TR

                  100,7

                  ZZ

                  100,7

                  0805 50 10

                  AR

                  179,3

                  TR

                  82,0

                  UY

                  126,7

                  ZA

                  158,1

                  ZZ

                  136,5

                  0806 10 10

                  BR

                  182,9

                  EG

                  206,5

                  MA

                  170,3

                  TR

                  141,2

                  ZZ

                  175,2

                  0808 10 80

                  AR

                  62,2

                  BR

                  85,7

                  CL

                  90,7

                  CN

                  120,3

                  NZ

                  123,8

                  PE

                  21,0

                  US

                  131,0

                  ZA

                  100,7

                  ZZ

                  91,9

                  0808 30 90

                  AR

                  35,0

                  CL

                  88,7

                  TR

                  132,4

                  ZA

                  99,6

                  ZZ

                  88,9

                  0809 30

                  MK

                  60,4

                  TR

                  125,7

                  ZZ

                  93,1

                  0809 40 05

                  BA

                  41,0

                  ZA

                  207,0

                  ZZ

                  124,0

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


title: Commission Implementing Regulation (EU) No 356/2013 of 18 April 2013 approving the active substance halosulfuron-methyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011  Text with EEA relevance

text:
               19.4.2013

               EN

               Official Journal of the European Union

               L 109/18

         COMMISSION IMPLEMENTING REGULATION (EU) No 356/2013
   of 18 April 2013
   approving the active substance halosulfuron-methyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Articles 13(2) and 78(2) thereof,
   Whereas:

               (1)

               In accordance with Article 80(1)(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 halosulfuron-methyl 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, Italy received on 19 May 2005 an application from Nissan Chemical Europe S.A.R.L. for the inclusion of the active substance halosulfuron-methyl 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 30 March 2007.

               (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 halosulfuron-methyl (4) on 26 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 the draft assessment report was finalised on 15 March 2013 in the format of the Commission review report for halosulfuron-methyl.

               (5)

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

               (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 halosulfuron-methyl. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the update of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

               (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 halosulfuron-methyl, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
   Article 2
   Re-evaluation of plant protection products
   1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing halosulfuron-methyl 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 halosulfuron-methyl as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 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 halosulfuron-methyl 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 halosulfuron-methyl 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, 18 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 236, 31.8.2006, p. 31.

      (4)  EFSA Journal (2012) 10(11):2987. 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

                  Halosulfuron-methyl
                  CAS No 100785-20-1
                  CIPAC No 785.201

                  methyl 3-chloro-5-(4,6-dimethoxypyrimidin-2-ylcarbamoylsulfamoyl)-1-methylpyrazole-4-carboxylate

                  ≥ 980 g/kg

                  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 halosulfuron-methyl, 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 risk of leakage to groundwater of the metabolite ‘halosulfuron rearrangement’ (HSR) (2) under vulnerable conditions. This metabolite is considered toxicologically relevant based on the available information for halosulfuron,

                              —

                              the risk to non-target terrestrial plants.

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

                              (a)

                              information as regards the equivalence between the technical specifications of the material, as commercially manufactured, and those of the material used in the toxicological and ecotoxicological studies;

                              (b)

                              information on the toxicological relevance of the impurities present in the technical specification of the material as commercially manufactured;

                              (c)

                              data to clarify the potential genotoxic properties of chlorosulfonamide acid (3).

                        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.

         (2)  3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl-1H-pyrazole-4-carboxylic acid.

         (3)  3-chloro-1-methyl-5-sulfamoyl-1H-pyrazole-4-carboxylic acid.

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

                     ‘35

                     Halosulfuron-methyl
                     CAS No 100785-20-1
                     CIPAC No 785.201

                     methyl 3-chloro-5-(4,6-dimethoxypyrimidin-2-ylcarbamoylsulfamoyl)-1-methylpyrazole-4-carboxylate

                     ≥ 980 g/kg

                     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 halosulfuron-methyl, 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 risk of leakage to groundwater of the metabolite ‘halosulfuron rearrangement’ (HSR) (1) under vulnerable conditions. This metabolite is considered toxicologically relevant based on the available information for halosulfuron,

                                 —

                                 the risk to non-target terrestrial plants.

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

                                 (a)

                                 information as regards the equivalence between the specifications of the technical material, as commercially manufactured, and the test material used in the toxicological and ecotoxicological studies;

                                 (b)

                                 information on the toxicological relevance of the impurities present in the technical specification as commercially manufactured;

                                 (c)

                                 data to clarify the potential genotoxic properties of chlorosulfonamide acid (2).

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

         (1)  3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl-1H-pyrazole-4-carboxylic acid.

         (2)  3-chloro-1-methyl-5-sulfamoyl-1H-pyrazole-4-carboxylic acid.’


title: Commission Implementing Regulation (EU) No 735/2012 of 14 August 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance potassium hydrogen carbonate  Text with EEA relevance

text:
               15.8.2012

               EN

               Official Journal of the European Union

               L 218/3

         COMMISSION IMPLEMENTING REGULATION (EU) No 735/2012
   of 14 August 2012
   amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance potassium hydrogen carbonate
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2)(c) thereof,
   Whereas:

               (1)

               The active substance potassium hydrogen carbonate was included in Annex I to Council Directive 91/414/EEC (2) by Commission Directive 2008/127/EC (3) in accordance with the procedure provided for in Article 24b of Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (4). Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, this substance is deemed to have been approved under that Regulation and is listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (5).

               (2)

               In accordance with Article 25a of Regulation (EC) No 2229/2004, the European Food Safety Authority, hereinafter ‘the Authority’, presented to the Commission its view on the draft review report for potassium hydrogen carbonate (6) on 16 December 2011. The draft review report and the view of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 13 July 2012 in the format of the Commission review report for potassium hydrogen carbonate.

               (3)

               The Authority communicated its view on potassium hydrogen carbonate to the notifier, and the Commission invited it to submit comments on the review report.

               (4)

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

               (5)

               In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to amend the conditions of approval of potassium hydrogen carbonate. Taking into account the fact that the use of potassium hydrogen carbonate as insecticide was assessed by Belgium and has not shown additional risks, it is appropriate to allow this use in addition to the use as fungicide.

               (6)

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

               (7)

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

               (8)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 February 2013.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 14 August 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 344, 20.12.2008, p. 89.

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

      (5)  OJ L 153, 11.6.2011, p. 1.

      (6)  Conclusion on the peer review of the pesticide risk assessment of the active substance potassium hydrogen carbonate, EFSA Journal 2012; 10(1):2524. Available online: www.efsa.europa.eu/efsajournal.htm

      ANNEX
      In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 244 on the active substance potassium hydrogen carbonate is replaced by the following:

                     Number

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘244

                     Potassium hydrogen carbonate
                     CAS No 298-14-6
                     CIPAC No 853

                     Potassium hydrogen carbonate

                     ≥ 99,5 %
                     Impurities:

                                 Pb max. 10 mg/kg

                                 As max. 3 mg/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as fungicide and 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 potassium hydrogen carbonate (SANCO/2625/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 July 2012 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to the risk to honeybees. Conditions of use shall include, where appropriate, risk mitigation measures.’

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


title: Commission Implementing Regulation (EU) No 746/2012 of 16 August 2012 approving the active substance Adoxophyes orana granulovirus , 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:
               17.8.2012

               EN

               Official Journal of the European Union

               L 219/15

         COMMISSION IMPLEMENTING REGULATION (EU) No 746/2012
   of 16 August 2012
   approving the active substance Adoxophyes orana granulovirus, 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 Adoxophyes orana granulovirus 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 Germany received on 29 November 2004 an application from Andermatt Biocontrol GmbH for the inclusion of the active substance Adoxophyes orana granulovirus 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 13 August 2008.

               (4)

               The draft assessment report was peer reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the peer review of the pesticide risk assessment of the active substance Adoxophyes orana granulovirus
                   (4) on 4 April 2012. The draft assessment report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and was finalised on 13 July 2012 in the format of the Commission review report for Adoxophyes orana granulovirus.

               (5)

               It has appeared from the various examinations made that plant protection products containing Adoxophyes orana granulovirus 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 Adoxophyes orana granulovirus.

               (6)

               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 Adoxophyes orana granulovirus. 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.

               (7)

               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.

               (8)

               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.

               (9)

               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 Adoxophyes orana granulovirus, 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 Adoxophyes orana granulovirus as an active substance by 31 July 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 Adoxophyes orana granulovirus 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 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 Adoxophyes orana granulovirus as the only active substance, where necessary, amend or withdraw the authorisation by 31 July 2014 at the latest; or

               (b)

               in the case of a product containing Adoxophyes orana granulovirus as one of several active substances, where necessary, amend or withdraw the authorisation by 31 July 2014 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or substances, whichever is the latest.

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

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 16 August 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 274, 18.10.2007, p. 15.

      (4)  EFSA Journal 2012; 10(4):2654. 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

                     Adoxophyes orana granulovirus

                  Culture collection No DSM BV-0001
                  CIPAC No 782

                  Not applicable

                  No relevant impurities

                  1 February 2013

                  31 January 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 Adoxophyes orana granulovirus, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 July 2012 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

                     ‘26

                        Adoxophyes orana granulovirus

                     Culture collection No DSM BV-0001
                     CIPAC No 782

                     Not applicable

                     No relevant impurities

                     1 February 2013

                     31 January 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 Adoxophyes orana granulovirus, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 July 2012 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 140/2014 of 13 February 2014 approving the active substance spinetoram, 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:
               14.2.2014

               EN

               Official Journal of the European Union

               L 44/35

      COMMISSION IMPLEMENTING REGULATION (EU) No 140/2014
   of 13 February 2014
   approving the active substance spinetoram, 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 spinetoram the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2008/740/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 17 October 2007 an application from Dow AgroSciences Ltd for the inclusion of the active substance spinetoram in Annex I to Directive 91/414/EEC. Decision 2008/740/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 23 February 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 spinetoram (4) on 6 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 spinetoram.

               (5)

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

               (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 spinetoram. 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 spinetoram, 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 spinetoram 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 spinetoram 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 spinetoram 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 spinetoram 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, 13 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 2008/740/EC of 12 September 2008 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of spinetoram in Annex I to Council Directive 91/414/EEC (OJ L 249, 18.9.2008, p. 21).

      (4)  EFSA Journal 2013; 11(5):3220. 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

                  Spinetoram
                  CAS No 935545-74-7
                  CIPAC No 802

                                 XDE-175-J (Major factor)

                              (2R,3aR,5aR,5bS,9S,13S,14R,16aS, 16bR)-2-(6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyranosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methylpyran-2-yloxy]-9-ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro-14-methyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione

                                 XDE_175-L (Minor factor)

                              (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyranosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methylpyran-2-yloxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione

                  ≥ 830 g/kg
                  50-90 % XDE-175-J; and
                  50-10 % XDE-175-L
                  Tolerance limits (g/kg):
                  XDE-175-J = 581-810
                  XDE-175-L = 83-270

                  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 spinetoram, 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 risk to non-target arthropods in-field;

                              (c)

                              the risk to bees during the application (overspray) and subsequently.

                        Conditions of use shall include risk mitigation measures, where appropriate.
                  The applicant shall submit confirmatory information as regards the equivalence between the stereochemistry of metabolites identified in the metabolism/degradation studies and in the testing material used for the toxicity and ecotoxicity studies.
                  The applicant shall submit to the Commission, the Member States and the Authority the relevant information within 6 months after the adoption of pertinent guidance on the assessment of isomers.

         (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

                     ‘67

                     Spinetoram
                     CAS No 935545-74-7
                     CIPAC No 802

                                    XDE-175-J (Major factor)

                                 (2R,3aR,5aR,5bS,9S,13S,14R,16aS, 16bR)-2-(6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyranosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methylpyran-2-yloxy]-9-ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro-14-methyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione

                                    XDE_175-L (Minor factor)

                                 (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyranosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methylpyran-2-yloxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione

                     ≥ 830 g/kg
                     50-90 % XDE-175-J;
                     and
                     50-10 % XDE-175-L
                     Tolerance limits (g/kg):
                     XDE-175-J = 581-810
                     XDE-175-L = 83-270

                     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 spinetoram, 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 risk to non-target arthropods in-field;

                                 (c)

                                 the risk to bees during the application (overspray) and subsequently.

                           Conditions of use shall include risk mitigation measures, where appropriate.
                     The applicant shall submit confirmatory information as regards the equivalence between the stereochemistry of metabolites identified in the metabolism/degradation studies and in the testing material used for the toxicity and ecotoxicity studies.
                     The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 31 December 2014.’

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


title: Commission Implementing Regulation (EU) No 85/2014 of 30 January 2014 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval period of the active substance copper compounds  Text with EEA relevance

text:
               31.1.2014

               EN

               Official Journal of the European Union

               L 28/34

      COMMISSION IMPLEMENTING REGULATION (EU) No 85/2014
   of 30 January 2014
   amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval period of the active substance copper compounds
   (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 approval of the active substance copper compounds will expire on 30 November 2016. An application has been submitted for the renewal of the approval of this active substance. As the requirements laid down in Commission Implementing Regulation (EU) No 844/2012 (3) apply to this active substance, it is necessary to allow applicants sufficient time to complete the renewal procedure in accordance with that Regulation. Consequently, the approval of this active substance is likely to expire before a decision has been taken on its renewal. It is therefore necessary to extend its approval period.

               (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, 30 January 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
      In Part A of the Annex to Implementing Regulation (EU) No 540/2011, in the sixth column, expiration of approval, of row 277, copper compounds, the date of 30 November 2016 is replaced by 31 January 2018.


title: Commission Implementing Regulation (EU) No 175/2013 of 27 February 2013 amending Implementing Regulation (EU) No 540/2011 as regards the withdrawal of the approval of the active substance didecyldimethylammonium chloride  Text with EEA relevance

text:
               28.2.2013

               EN

               Official Journal of the European Union

               L 56/4

         COMMISSION IMPLEMENTING REGULATION (EU) No 175/2013
   of 27 February 2013
   amending Implementing Regulation (EU) No 540/2011 as regards the withdrawal of the approval of the active substance didecyldimethylammonium chloride
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the second alternative of Article 21(3) and Article 78(2) thereof,
   Whereas:

               (1)

               Commission Directive 2009/70/EC (2) included didecyldimethylammonium chloride (DDAC) as active substance in Annex I to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (3), with the condition that the Member States concerned ensure that the notifier at whose request DDAC was included in that Annex provides further confirmatory information on the specification of that active substance, as manufactured, by 1 January 2010.

               (2)

               Active substances included in Annex I of Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (4).

               (3)

               On 25 October 2011, the notifier submitted additional information with a view to complying with the obligation to submit further information on the specification of the active substance, as manufactured, to the rapporteur Member State, the Netherlands.

               (4)

               The Netherlands assessed the additional information submitted by the notifier. It submitted its assessment, in the form of an addendum to the draft assessment report to the other Member States, the Commission and the European Food Safety Authority.

               (5)

               In the light of the additional information provided by the notifier, the Commission considered that the further confirmatory information required had not been provided.

               (6)

               The Commission invited the notifier to submit its comments on the considerations of the Commission.

               (7)

               The Commission has come to the conclusion that the information submitted is incomplete and does not allow to conclude on the degree of purity and, in particular, on the identity and content of the impurities.

               (8)

               It is appropriate to withdraw the approval of the active substance DDAC by deleting row 291 of Part A of the Annex to Implementing Regulation (EU) No 540/2011.

               (9)

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

               (10)

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

               (11)

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

               (12)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Amendment to Implementing Regulation (EU) No 540/2011
   In Part A of the Annex to Implementing Regulation (EU) No 540/2011, the row No 291 didecyldimethylammonium chloride, is deleted.
   Article 2
   Transitional measures
   Member States shall ensure that authorisations for plant protection products containing didecyldimethylammonium chloride are withdrawn by 20 June 2013.
   Article 3
   Grace period
   Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire 12 months after withdrawal of the respective authorisation at the latest.
   Article 4
   Entry into force
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 27 February 2013.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  OJ L 164, 26.6.2009, p. 59.

      (3)  OJ L 230, 19.8.1991, p. 1.

      (4)  OJ L 153, 11.6.2011, p. 1.


title: Commission Implementing Regulation (EU) No 781/2013 of 14 August 2013 amending Implementing Regulation (EU) No 540/2011, as regards the conditions of approval of the active substance fipronil, and prohibiting the use and sale of seeds treated with plant protection products containing this active substance  Text with EEA relevance

text:
               15.8.2013

               EN

               Official Journal of the European Union

               L 219/22

         COMMISSION IMPLEMENTING REGULATION (EU) No 781/2013
   of 14 August 2013
   amending Implementing Regulation (EU) No 540/2011, as regards the conditions of approval of the active substance fipronil, and prohibiting the use and sale of seeds treated with plant protection products containing this 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 the first alternative of Article 21(3), Article 49(2) and Article 78(2) thereof,
   Whereas:

               (1)

               The active substance fipronil was included in Annex I to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (2) by Commission Directive 2007/52/EC (3).

               (2)

               Commission Directive 2010/21/EU (4) amended Annex I to Directive 91/414/EEC as regards the specific provisions relating to fipronil.

               (3)

               Active substances included in Annex I to Directive 91/414/EEC are deemed to be approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (5).

               (4)

               Based on new information received from Italy concerning risks to honeybees caused by coated maize seeds treated with plant protection products containing fipronil, the Commission decided to review the approval of that active substance. The Commission, in accordance with Article 21(2) of Regulation (EC) No 1107/2009, asked the European Food Safety Authority, hereinafter ‘the Authority’, for scientific and technical assistance to assess this new information and to review the risk assessment of fipronil as regards its impact on bees.

               (5)

               The Authority presented its conclusion on the risk assessment of fipronil as regards bees on 27 May 2013 (6).

               (6)

               The Authority identified for the use as seed treatment in maize, high acute risks for bees from plant protection products containing the active substance fipronil. The Authority identified, in particular, a high acute risk for bees resulting from dust. In addition, unacceptable risks due to acute or chronic effects on colony survival and development could not be excluded for several crops. Furthermore, the Authority identified some missing information for each of the evaluated uses, in particular as regards long term risk to honeybees from dust exposure, from potential exposure to residues in pollen and nectar, from potential exposure to guttation fluid and from exposure to residues in succeding crops, weeds and soil.

               (7)

               In the light of the new scientific and technical knowledge, the Commission considered that there are indications that some approved uses of fipronil do not satisfy the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 with respect to the impact on bees and that the high risk for bees could not be excluded except by imposing further restrictions.

               (8)

               The Commission invited the notifier to submit comments.

               (9)

               The conclusion of the Authority was 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 an addendum to the review report for fipronil.

               (10)

               The Commission has come to the conclusion that a high risk for bees cannot be excluded except by imposing further restrictions.

               (11)

               It is confirmed that the active substance fipronil is deemed to have been approved under Regulation (EC) No 1107/2009. In order to minimise the exposure of bees, it is, however, appropriate to restrict the use of plant protection products containing fipronil and to provide for specific risk mitigation measures for the protection of bees. In particular the use of plant protection products containing fipronil should be limited to the treatment of seeds intended to be sown in greenhouses and to the treatment of seeds of leek, onions, shallots and the group of Brassica vegetables intended to be sown in fields and harvested before flowering. Crops which are harvested before flowering are not considered attractive to bees.

               (12)

               Concerning applications of fipronil which may be authorised under Implementing Regulation (EU) No 540/2011, it is appropriate to require further confirmatory information.

               (13)

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

               (14)

               Risks for bees from treated seeds have been identified in particular from exposure via dust as regards the use in maize. Taking into consideration the risks linked with the use of treated seeds, the use and the placing on the market of seeds treated with plant protection products containing fipronil should be prohibited except for seeds sown in greenhouses and for treatment of seeds of leek, onions, shallots and the group of Brassica vegetables sown in fields and harvested before flowering. Pending submission of missing information regarding the use of treated sunflower seeds, it is appropriate to apply similar measures as for maize.

               (15)

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

               (16)

               For plant protection products containing fipronil, where Member States grant any period of grace in accordance with Article 46 of Regulation (EC) No 1107/2009, this period should expire on 28 February 2014 at the latest. Accordingly, the prohibition of placing on the market of treated seeds should apply as of 1 March 2014 in order to allow for a period of transition.

               (17)

               Within two years from the date of entry into force of the present Regulation the Commission will initiate a review of the new scientific information, including new studies, information on new product formulations provided by the applicants, which it has received.

               (18)

               Article 36(3) of Regulation (EC) No 1107/2009 provides that Member States may, under certain circumstances, impose further risk mitigation measures or restrictions to the placing on the market or use of the plant protection products containing fipronil. Concerning the placing on the market and use of the seeds treated with plant protection products containing fipronil, Regulation (EC) No 1107/2009 provides for the possibility of Member States to take emergency measures pursuant to Article 71 thereof.

               (19)

               Seeds treated with plant protection products containing fipronil, which are subject to the restrictions referred to in Article 1 of this Regulation, may be used for experiments or tests for research or development purposes pursuant to Article 54 of Regulation (EC) No 1107/2009.

               (20)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Amendment to Implementing Regulation (EU) No 540/2011
   The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
   Article 2
   Prohibition of placing on the market of treated seeds
   Seeds of crops which have been treated with plant protection products containing fipronil shall not be used or placed on the market with the exception of seeds intended to be sown in greenhouses and seeds of leek, onions, shallots, and the group of Brassica vegetables intended to be sown in fields and harvested before flowering.
   Article 3
   Transitional measures
   Member States shall, in accordance with Regulation (EC) No 1107/2009, where necessary amend or withdraw existing authorisations for plant protection products containing fipronil as active substance by 31 December 2013.
   Article 4
   Period of grace
   Any period of grace granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire on 28 February 2014 at the latest.
   Article 5
   Entry into force
   This Regulation shall enter into force and apply from the day following that of its publication in the Official Journal of the European Union.
   However, Article 2 shall apply from 1 March 2014.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 14 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 214, 17.8.2007, p. 3.

      (4)  OJ L 65, 13.3.2010, p. 27.

      (5)  OJ L 153, 11.6.2011, p. 1.

      (6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment for bees for the active substance fipronil. EFSA Journal 2013;11(5):3158. [51 pp.] doi:10.2903/j.efsa.2013.3158. Available online: www.efsa.europa.eu/efsajournal

      ANNEX

         Amendments to the Annex to Implementing Regulation (EU) No 540/2011

      The column ‘Specific provisions’ of row 157, fipronil, of Part A of the Annex to Implementing Regulation (EU) No 540/2011 is replaced by the following:

         ‘PART A
         Only uses as insecticide for use as seed treatment may be authorised. Uses shall only be authorised for seeds intended to be sown in greenhouses and seeds of leek, onions, shallots and the group of Brassica vegetables intended to be sown in fields and harvested before flowering.
         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 fipronil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2007 and the conclusions of the addendum of the review report on fipronil 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:

                     (a)

                     the packaging of the marketed products to avoid the generation of photodegradation products of concern;

                     (b)

                     the potential for groundwater contamination, especially from metabolites which are more persistent than the parent compound, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

                     (c)

                     the protection of granivorous birds and mammals, aquatic organisms, non-target arthropods and honey bees.

               Member States shall also ensure that:

                     (a)

                     the seed coating shall only be performed in professional seed treatment facilities; those facilities shall apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised;

                     (b)

                     adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission;

                     (c)

                     the label of the treated seeds shall include the indication that the seeds were treated with fipronil and sets out the risk mitigation measures provided for in the authorisation;

                     (d)

                     monitoring programmes shall be initiated to verify the real exposure of bees to fipronil in areas extensively used by bees for foraging or by beekeepers, where and as appropriate.

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

                     (a)

                     the risk to pollinators other than honey bees;

                     (b)

                     the acute and long-term risk to colony survival and development, and the risk to bee brood from plant and soil metabolites, except the soil photolysis metabolites;

                     (c)

                     the potential exposure to dust drift emitted during the drilling procedure and the acute and long-term risk to colony survival and development, and the risk to bee brood for situations where bees forage on vegetation exposed to dust drift;

                     (d)

                     the acute and long-term risk to colony survival and development, and the risk to bee brood from foraging on insect honeydew;

                     (e)

                     the potential exposure to guttation fluid and the acute and long-term risk to colony survival and development, and the risk to bee brood;

                     (f)

                     the potential exposure to residues in nectar and pollen, honeydew and guttation fluid of succeeding crops or weeds occurring in fields, including the persistent soil metabolites (RPA 200766, MB 46136 and MB 45950).

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