title: Commission Implementing Regulation (EU) No 664/2013 of 11 July 2013 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               12.7.2013

               EN

               Official Journal of the European Union

               L 191/7

         COMMISSION IMPLEMENTING REGULATION (EU) No 664/2013
   of 11 July 2013
   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, 11 July 2013.

            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

                  MK

                  33,9

                  TR

                  105,8

                  ZZ

                  69,9

                  0709 93 10

                  TR

                  133,1

                  ZZ

                  133,1

                  0805 50 10

                  AR

                  87,0

                  TR

                  70,0

                  UY

                  80,2

                  ZA

                  97,8

                  ZZ

                  83,8

                  0808 10 80

                  AR

                  144,6

                  BR

                  105,5

                  CL

                  129,9

                  CN

                  96,2

                  NZ

                  144,2

                  US

                  155,0

                  ZA

                  115,1

                  ZZ

                  127,2

                  0808 30 90

                  AR

                  128,3

                  CL

                  147,4

                  CN

                  66,6

                  ZA

                  128,8

                  ZZ

                  117,8

                  0809 10 00

                  IL

                  275,4

                  TR

                  193,7

                  ZZ

                  234,6

                  0809 29 00

                  TR

                  346,3

                  US

                  793,8

                  ZZ

                  570,1

                  0809 30

                  TR

                  211,8

                  ZZ

                  211,8

                  0809 40 05

                  BA

                  195,8

                  IL

                  99,1

                  MA

                  99,1

                  ZA

                  125,3

                  ZZ

                  129,8

         (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 369/2013 of 22 April 2013 approving the active substance potassium phosphonates, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011  Text with EEA relevance

text:
                  23.4.2013

                  EN

                  Official Journal of the European Union

                  L 111/39

         COMMISSION IMPLEMENTING REGULATION (EU) No 369/2013
         of 22 April 2013
         approving the active substance potassium phosphonates, 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 potassium phosphonates (initially referred to as ‘potassium phosphite’) the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2003/636/EC (3).

                     (2)

                     In accordance with Article 6(2) of Directive 91/414/EEC, France received on 22 August 2002 an application from Luxembourg Industries (Pamol) Ltd for the inclusion of the active substance potassium phosphonates in Annex I to Directive 91/414/EEC. Decision 2003/636/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 1 February 2005.

                     (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 potassium phosphonates (4) on 16 December 2011. 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 potassium phosphonates.

                     (5)

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

                     (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 potassium phosphonates. 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 potassium phosphonates, 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 potassium phosphonates 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 potassium phosphonates 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 potassium phosphonates 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 potassium phosphonates 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, 22 April 2013.

                  For the Commission

                  The President

               José Manuel BARROSO

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

            (2)  OJ L 230, 19.8.1991, p. 1.

            (3)  OJ L 221, 4.9.2003, p. 42.

            (4)  EFSA Journal 2012; 10(12):2963. 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

                        Potassium phosphonates (no ISO name)
                        CAS No
                        13977-65-6 for potassium hydrogen phosphonate
                        13492-26-7 for dipotassium phosphonate
                        Mixture: none
                        CIPAC No 756 (for potassium phosphonates)

                        Potassium hydrogen phosphonate,
                        Dipotassium phosphonate

                        31,6 to 32,6 % phosphonate ions (sum of hydrogen phosphonate and phosphonate ions)
                        17,8 to 20,0 % potassium
                        ≥ 990 g/kg on dry weight basis

                        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 potassium phosphonates, 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 to birds and mammals,

                                    —

                                    the risk of eutrophication of surface water, if the substance is applied in regions or under conditions favouring a quick oxidation of the active substance in surface water.

                              Conditions of use shall include risk mitigation measures, where appropriate.
                        The applicant shall submit confirmatory information as regards the long-term risk to insectivorous birds.
                        The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.

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

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

                           Number

                           Common Name, Identification Numbers

                           IUPAC Name

                           Purity (*1)

                           Date of approval

                           Expiration of approval

                           Specific provisions

                           ‘40

                           Potassium phosphonates (no ISO name)
                           CAS No
                           13977-65-6 for potassium hydrogen phosphonate
                           13492-26-7 for dipotassium phosphonate
                           Mixture: none
                           CIPAC No 756 (for potassium phosphonates)

                           Potassium hydrogen phosphonate,
                           Dipotassium phosphonate

                           31,6 to 32,6 % phosphonate ions (sum of hydrogen phosphonate and phosphonate ions)
                           17,8 to 20,0 % potassium
                           ≥ 990 g/kg on dry weight basis

                           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 potassium phosphonates, 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 to birds and mammals,

                                       —

                                       the risk of eutrophication of surface water, if the substance is applied in regions or under conditions favouring a quick oxidation of the active substance in surface water.

                                 Conditions of use shall include risk mitigation measures, where appropriate.
                           The applicant shall submit confirmatory information as regards the long-term risk to insectivorous birds.
                           The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.’

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


title: Commission Implementing Regulation (EU) 2015/415 of 12 March 2015 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances ethephon and fenamiphos  Text with EEA relevance

text:
               13.3.2015

               EN

               Official Journal of the European Union

               L 68/28

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/415
   of 12 March 2015
   amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances ethephon and fenamiphos
   (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 ethephon and fenamiphos will expire on 31 July 2017. Applications have been submitted for the renewal of the approval of those active substances. As the requirements laid down in Commission Implementing Regulation (EU) No 844/2012 (3) apply to those active substances, it is necessary to provide for sufficient time to complete the renewal procedure in accordance with that Regulation. Consequently, the approvals of those active substances are likely to expire before a decision has been taken on their renewal. It is therefore necessary to extend their approval periods.

               (3)

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

               (4)

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

               (5)

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

               (6)

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

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

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 12 March 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

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

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

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

                  (1)

                  in the sixth column, expiration of approval, of row 141, fenamiphos, the date of ‘31 July 2017’ is replaced by ‘31 July 2018’;

                  (2)

                  in the sixth column, expiration of approval, of row 142, ethephon, the date of ‘31 July 2017’ is replaced by ‘31 July 2018’.


title: Commission Implementing Regulation (EU) No 584/2014 of 28 May 2014 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               29.5.2014

               EN

               Official Journal of the European Union

               L 160/29

         COMMISSION IMPLEMENTING REGULATION (EU) No 584/2014
   of 28 May 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, 28 May 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

                  0702 00 00

                  AL

                  45,8

                  MA

                  33,4

                  MK

                  66,7

                  TR

                  64,5

                  ZZ

                  52,6

                  0707 00 05

                  AL

                  25,2

                  MK

                  30,0

                  TR

                  119,6

                  ZZ

                  58,3

                  0709 93 10

                  MA

                  29,9

                  TR

                  111,7

                  ZZ

                  70,8

                  0805 10 20

                  EG

                  44,2

                  MA

                  41,4

                  ZA

                  72,1

                  ZZ

                  52,6

                  0805 50 10

                  TR

                  121,8

                  ZA

                  139,4

                  ZZ

                  130,6

                  0808 10 80

                  AR

                  95,4

                  BR

                  97,8

                  CL

                  105,8

                  CN

                  98,8

                  MK

                  26,7

                  NZ

                  141,3

                  US

                  170,7

                  ZA

                  104,2

                  ZZ

                  105,1

         (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 496/2014 of 14 May 2014 approving the active substance acequinocyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011  Text with EEA relevance

text:
               15.5.2014

               EN

               Official Journal of the European Union

               L 143/1

         COMMISSION IMPLEMENTING REGULATION (EU) No 496/2014
   of 14 May 2014
   approving the active substance acequinocyl, 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 acequinocyl the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2003/636/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the Netherlands received on 17 March 2003 an application from Agro-Kanesho Co. Ltd for the inclusion of the active substance acequinocyl in Annex I to Directive 91/414/EEC. Decision 2003/636/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, the Netherlands, submitted a draft assessment report on 8 March 2005. In accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 (4) additional information was requested from the applicant on 13 July 2011. The evaluation of the additional data by the Netherlands was submitted in the format of an updated draft assessment report in November 2011.

               (4)

               The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion (5) on the peer review of the pesticide risk assessment of the active substance acequinocyl on 19 April 2013. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 20 March 2014 in the format of the Commission review report for acequinocyl.

               (5)

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

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

               (9)

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

               (10)

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

               (11)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of active substance
   The active substance acequinocyl, 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 acequinocyl as an active substance by 28 February 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 acequinocyl 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 August 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 acequinocyl as the only active substance, where necessary, amend or withdraw the authorisation by 29 February 2016 at the latest; or

               (b)

               in the case of a product containing acequinocyl as one of several active substances, where necessary, amend or withdraw the authorisation by 29 February 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 September 2014.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 14 May 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 2003/636/EC of 2 September 2003 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of potassium phosphite, acequinocyl and cyflufenamid in Annex I to Council Directive 91/414/EEC concerning the placing of plant-protection products on the market (OJ L 221, 4.9.2003, p. 42).

      (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)  European Food Safety Authority, 2013. Conclusion on the peer review of the pesticide risk assessment of the active substance acequinocyl. EFSA Journal 2013,11(5):3212, 71 pp. doi:10.2903/j.efsa.2013.3212.

      (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

                  Acequinocyl CAS No 57960-19-7 CIPAC No 760

                  3-dodecyl-1,4-dihydro-1,4-dioxo-2-naphthyl acetate

                  ≥ 960 g/kg

                  1 September 2014

                  31 August 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 acequinocyl, 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 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              —

                              the protection of workers and operators;

                              —

                              the risk to birds, mammals and aquatic organisms.

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

                              (a)

                              an analytical method for residues in body fluids and tissues;

                              (b)

                              the acceptability of the long-term risk to small granivorous birds and small herbivorous and frugivorous mammals, concerning the use on apple and pear orchards;

                              (c)

                              the acceptability of the long-term risk to small omnivorous and small herbivorous mammals, concerning the use on outdoor ornamentals.

                        The applicant shall submit that information to the Commission, the Member States and the Authority by 31 August 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

                     ‘72

                     Acequinocyl CAS No 57960-19-7 CIPAC No 760

                     3-dodecyl-1,4-dihydro-1,4-dioxo-2-naphthyl acetate

                     ≥ 960 g/kg

                     1 September 2014

                     31 August 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 acequinocyl, 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 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 —

                                 the protection of workers and operators;

                                 —

                                 the risk to birds, mammals and aquatic organisms.

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

                                 (a)

                                 an analytical method for residues in body fluids and tissues;

                                 (b)

                                 the acceptability of the long-term risk to small granivorous birds and small herbivorous and frugivorous mammals, concerning the use on apple and pear orchards;

                                 (c)

                                 the acceptability of the long-term risk to small omnivorous and small herbivorous mammals, concerning the use on outdoor ornamentals.

                           The applicant shall submit that information to the Commission, the Member States and the Authority by 31 August 2016.’

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


title: Commission Implementing Regulation (EU) No 365/2013 of 22 April 2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance glufosinate  Text with EEA relevance

text:
                  23.4.2013

                  EN

                  Official Journal of the European Union

                  L 111/27

         COMMISSION IMPLEMENTING REGULATION (EU) No 365/2013
         of 22 April 2013
         amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance glufosinate
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the second alternative of Articles 21(3) and 78(2) thereof,
         Whereas:

                     (1)

                     Commission Directive 2007/25/EC (2) included glufosinate 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), under the condition that the Member States concerned ensure that the notifier at whose request glufosinate was included in that Annex provide further confirmatory information on the risk for mammals and non-target arthropods in apple orchards.

                     (2)

                     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 (4).

                     (3)

                     The notifier submitted additional information taking the form of studies with a view to confirm the risk assessment for mammals and non-target arthropods in apple orchards to the rapporteur Member State Sweden within the time period provided for its submission.

                     (4)

                     Sweden assessed the additional information submitted by the notifier. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter ‘the Authority’, on 9 March 2010.

                     (5)

                     The Commission consulted the Authority which presented its opinion on the risk assessment of glufosinate on 8 March 2012 (5). The draft assessment report, the additional report and the opinion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 15 March 2013 in the format of the Commission review report for glufosinate.

                     (6)

                     In the light of the additional information provided by the notifier, the Commission considered that the further confirmatory information required had not been provided and that a high risk for mammals and non-target arthropods could not be excluded except by imposing further restrictions.

                     (7)

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

                     (8)

                     It is confirmed that the active substance glufosinate is to be deemed to have been approved under Regulation (EC) No 1107/2009. In order to minimise the exposure of mammals and non-target arthropods, it is, however, appropriate to further restrict the uses of this active substance and to provide for specific risk mitigation measures for the protection of those species.

                     (9)

                     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 glufosinate.

                     (11)

                     For plant protection products containing glufosinate, 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
            The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

            Article 2
            Transitional measures
            Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary amend or withdraw existing authorisations for plant protection products containing glufosinate as active substance by 13 November 2013.

            Article 3
            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 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, 22 April 2013.

                  For the Commission

                  The President

               José Manuel BARROSO

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

            (2)  OJ L 106, 24.4.2007, p. 34.

            (3)  OJ L 230, 19.8.1991, p. 1.

            (4)  OJ L 153, 11.6.2011, p. 1.

            (5)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of confirmatory data submitted for the active substance glufosinate. EFSA Journal 2012; 10(3):2609. [14 pp.] doi:10.2903/j.efsa.2012.2609. Available online: www.efsa.europa.eu/efsajournal.htm

            ANNEX
            The column ‘Specific provisions’ of row 151, glufosinate, of Part A of the Annex to Implementing Regulation (EU) No 540/2011 is replaced by the following:

               ‘PART A
               Only uses as herbicide for band or spot application may be authorised at rates not exceeding 750 g active substance/ha (treated surface) per application and maximum two applications per year.
               PART B
               In assessing applications to authorise plant protection products containing glufosinate, notably as regards the operator and consumer exposure, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.
               For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on glufosinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006, shall be taken into account. In this overall assessment Member States shall pay particular attention to:

                           (a)

                           the operator, worker and bystander safety; conditions of authorisation shall include protective measures, where appropriate;

                           (b)

                           the potential for groundwater contamination, where the active substance is applied in regions with vulnerable soil or climatic conditions;

                           (c)

                           the protection of mammals, non-target arthropods and non-target plants.

                     Conditions of authorisation shall include the application of drift reducing nozzles and spray shields and shall provide for respective labelling of plant protection products. Those conditions shall include further risk mitigation measures, where appropriate.’.


title: Commission Implementing Regulation (EU) No 368/2013 of 22 April 2013 approving the active substance Helicoverpa armigera nucleopolyhedrovirus , in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011  Text with EEA relevance

text:
                  23.4.2013

                  EN

                  Official Journal of the European Union

                  L 111/36

         COMMISSION IMPLEMENTING REGULATION (EU) No 368/2013
         of 22 April 2013
         approving the active substance Helicoverpa armigera nucleopolyhedrovirus, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) and Article 78(2) thereof,
         Whereas:

                     (1)

                     In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For Helicoverpa armigera nucleopolyhedrovirus the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2007/560/EC (3).

                     (2)

                     In accordance with Article 6(2) of Directive 91/414/EEC Estonia received on 2 January 2007 an application from Andermatt Biocontrol GmbH for the inclusion of the active substance Helicoverpa armigera nucleopolyhedrovirus in Annex I to Directive 91/414/EEC. Decision 2007/560/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

                     (3)

                     For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 26 March 2009.

                     (4)

                     The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the review of the pesticide risk assessment of the active substance Helicoverpa armigera nucleopolyhedrovirus (4) on 10 August 2012. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and the draft assessment report was finalised on 15 March 2013 in the format of the Commission review report for Helicoverpa armigera nucleopolyhedrovirus.

                     (5)

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

                     (6)

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

                     (7)

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

                     (8)

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

                     (9)

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

                     (10)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Approval of active substance
            The active substance Helicoverpa armigera nucleopolyhedrovirus, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

            Article 2
            Re-evaluation of plant protection products

               1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing Helicoverpa armigera nucleopolyhedrovirus as an active substance by 30 November 2013.
               By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.

               2.   By way of derogation from paragraph 1, for each authorised plant protection product containing Helicoverpa armigera nucleopolyhedrovirus as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 May 2013 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
               Following that determination Member States shall:

                           (a)

                           in the case of a product containing Helicoverpa armigera nucleopolyhedrovirus as the only active substance, where necessary, amend or withdraw the authorisation by 30 November 2014 at the latest; or

                           (b)

                           in the case of a product containing Helicoverpa armigera nucleopolyhedrovirus as one of several active substances, where necessary, amend or withdraw the authorisation by 30 November 2014 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

            Article 3
            Amendments to Implementing Regulation (EU) No 540/2011
            The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

            Article 4
            Entry into force and date of application
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            It shall apply from 1 June 2013.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 22 April 2013.

                  For the Commission

                  The President

               José Manuel BARROSO

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

            (2)  OJ L 230, 19.8.1991, p. 1.

            (3)  OJ L 213, 15.8.2007, p. 29.

            (4)  EFSA Journal 2012; 10(9):2865. 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

                           Helicoverpa armigera nucleopolyhedrovirus

                        DSMZ number: BV-0003

                        Not applicable

                        Minimum concentration: 1,44 × 1013 OB/l (occlusion bodies/l)

                        1 June 2013

                        31 May 2023

                        For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Helicoverpa armigera nucleopolyhedrovirus, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account.

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

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

                           Number

                           Common name, identification numbers

                           IUPAC name

                           Purity (*1)

                           Date of approval

                           Expiration of approval

                           Specific provisions

                           ‘38

                              Helicoverpa armigera nucleopolyhedrovirus

                           DSMZ number: BV-0003

                           Not applicable

                           Minimum concentration: 1,44 × 1013 OB/l (occlusion bodies/l)

                           1 June 2013

                           31 May 2023

                           For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Helicoverpa armigera nucleopolyhedrovirus, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account.’

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


title: Commission Implementing Regulation (EU) No 127/2012 of 14 February 2012 amending Implementing Regulation (EU) No 540/2011 as regards an extension of the use of the active substance metazachlor  Text with EEA relevance

text:
               15.2.2012

               EN

               Official Journal of the European Union

               L 41/12

         COMMISSION IMPLEMENTING REGULATION (EU) No 127/2012
   of 14 February 2012
   amending Implementing Regulation (EU) No 540/2011 as regards an extension of the use of the active substance metazachlor
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2)(c) thereof,
   Whereas:

               (1)

               By Commission Directive 2008/116/EC (2) metazachlor was included as active substance in Annex I to Council Directive 91/414/EEC (3) for use as a herbicide at a maximum application rate of 1,0 kg/ha only every third year on the same field. Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, this substance is deemed to have been approved under that Regulation and is listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011, implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (4).

               (2)

               On 23 March 2010 one of the notifiers at whose request metazachlor was included in Annex I to Directive 91/414/EEC, submitted an application for an amendment to the specific provisions of use of metazachlor to allow more frequent applications on the same field, without however exceeding the total maximum amount of 1,0 kg/ha over a three-year period. That application was accompanied by additional information. It was submitted to the United Kingdom which had been designated rapporteur Member State by Commission Regulation (EC) No 1490/2002 (5).

               (3)

               The rapporteur Member State assessed the additional information submitted by the applicant and prepared an addendum to the draft assessment report. It submitted that addendum to the Commission on 4 January 2011 which communicated it to the other Member States and to the European Food Safety Authority for comments. The addendum to the draft assessment report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health on 24 January 2012 in the format of an addendum to the Commission review report for metazachlor.

               (4)

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

               (5)

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

               (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
   Amendment to Implementing Regulation (EU) No 540/2011
   In the column ‘Specific provisions’ of row number 217, metazachlor, of Part A of the Annex, Part A is replaced by the following:

      ‘PART A
      Only uses as herbicide may be authorised. Applications shall be limited to a total dose of not more than 1,0 kg metazachlor/ha in a three-year period on the same field.’

   Article 2
   Entry into force
   This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 14 February 2012.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  OJ L 337, 16.12.2008, p. 86.

      (3)  OJ L 230, 19.8.1991, p. 1.

      (4)  OJ L 153, 11.6.2011, p. 1.

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


title: Commission Implementing Regulation (EU) 2017/1788 of 22 September 2017 entering a name in the register of protected designations of origin and protected geographical indications (Ossolano (PDO))

text:
               4.10.2017

               EN

               Official Journal of the European Union

               L 256/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/1788
   of 22 September 2017
   entering a name in the register of protected designations of origin and protected geographical indications (Ossolano (PDO))
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
   Whereas:

               (1)

               Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Italy's application to register the name ‘Ossolano’ was published in the Official Journal of the European Union
                   (2).

               (2)

               As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Ossolano’ should therefore be entered in the register,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The name ‘Ossolano’ (PDO) is hereby entered in the register.
   The name specified in the first paragraph denotes a product in Class 1.3. — Cheeses, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).
   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, 22 September 2017.

            For the Commission,

            On behalf of the President,

         Phil HOGAN

            Member of the Commission

      (1)  OJ L 343, 14.12.2012, p. 1.

      (2)  OJ C 186, 10.6.2017, p. 16.

      (3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).


title: Commission Implementing Regulation (EU) No 141/2012 of 17 February 2012 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               18.2.2012

               EN

               Official Journal of the European Union

               L 47/20

         COMMISSION IMPLEMENTING REGULATION (EU) No 141/2012
   of 17 February 2012
   establishing the standard import values for determining the entry price of certain fruit and vegetables
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),
   Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
   Whereas:

               (1)

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

               (2)

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

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

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 17 February 2012.

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

            Director-General for Agriculture and Rural Development

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

      (2)  OJ L 157, 15.6.2011, p. 1.

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

                  (EUR/100 kg)

                  CN code

                  Third country code (1)

                  Standard import value

                  0702 00 00

                  IL

                  107,7

                  JO

                  78,3

                  MA

                  61,7

                  TN

                  94,1

                  TR

                  98,5

                  ZZ

                  88,1

                  0707 00 05

                  JO

                  124,9

                  MA

                  94,0

                  TR

                  168,6

                  ZZ

                  129,2

                  0709 93 10

                  MA

                  89,1

                  TR

                  151,1

                  ZZ

                  120,1

                  0805 10 20

                  EG

                  47,3

                  IL

                  61,7

                  MA

                  46,6

                  TN

                  49,8

                  TR

                  68,8

                  ZZ

                  54,8

                  0805 20 10

                  IL

                  131,8

                  MA

                  86,7

                  ZZ

                  109,3

                  0805 20 30, 0805 20 50, 0805 20 70, 0805 20 90

                  IL

                  114,9

                  MA

                  105,8

                  TR

                  72,1

                  ZZ

                  97,6

                  0805 50 10

                  EG

                  40,4

                  TR

                  54,2

                  ZZ

                  47,3

                  0808 10 80

                  CA

                  136,5

                  CL

                  98,4

                  CN

                  82,7

                  MK

                  31,8

                  US

                  162,6

                  ZZ

                  102,4

                  0808 30 90

                  AR

                  96,6

                  CL

                  141,4

                  CN

                  63,9

                  US

                  113,9

                  ZA

                  123,7

                  ZZ

                  107,9

         (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 320/2011 of 31 March 2011 fixing the import duties in the cereals sector applicable from 1 April 2011

text:
               1.4.2011

               EN

               Official Journal of the European Union

               L 86/69

         COMMISSION IMPLEMENTING REGULATION (EU) No 320/2011
   of 31 March 2011
   fixing the import duties in the cereals sector applicable from 1 April 2011
   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 (EU) No 642/2010 of 20 July 2010 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of import duties in the cereals sector (2), and in particular Article 2(1) thereof,
   Whereas:

               (1)

               Article 136(1) of Regulation (EC) No 1234/2007 states that the import duty on products falling within CN codes 1001 10 00, 1001 90 91, ex 1001 90 99 (high quality common wheat), 1002, ex 1005 other than hybrid seed, and ex 1007 other than hybrids for sowing, is to be equal to the intervention price valid for such products on importation increased by 55 %, minus the cif import price applicable to the consignment in question. However, that duty may not exceed the rate of duty in the Common Customs Tariff.

               (2)

               Article 136(2) of Regulation (EC) No 1234/2007 lays down that, for the purposes of calculating the import duty referred to in paragraph 1 of that Article, representative cif import prices are to be established on a regular basis for the products in question.

               (3)

               Pursuant to Article 2(2) of Regulation (EU) No 642/2010, the price to be used for the calculation of the import duty on products of CN codes 1001 10 00, 1001 90 91, ex 1001 90 99 (high quality common wheat), 1002 00, 1005 10 90, 1005 90 00 and 1007 00 90 is the daily cif representative import price determined as specified in Article 5 of that Regulation.

               (4)

               Import duties should be fixed for the period from 1 April 2011 and should apply until new import duties are fixed and enter into force,

         HAS ADOPTED THIS REGULATION:
   Article 1
   From 1 April 2011, the import duties in the cereals sector referred to in Article 136(1) of Regulation (EC) No 1234/2007 shall be those fixed in Annex I to this Regulation on the basis of the information contained in Annex II.
   Article 2
   This Regulation shall enter into force on 1 April 2011.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 31 March 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 187, 21.7.2010, p. 5.

      ANNEX I

         Import duties on the products referred to in Article 136(1) of Regulation (EC) No 1234/2007 applicable from 1 April 2011

                  CN code

                  Description

                  Import duties (1)

                  (EUR/t)

                  1001 10 00

                  Durum wheat, high quality

                  0,00

                  medium quality

                  0,00

                  low quality

                  0,00

                  1001 90 91

                  Common wheat seed

                  0,00

                  ex 1001 90 99

                  High quality common wheat, other than for sowing

                  0,00

                  1002 00 00

                  Rye

                  0,00

                  1005 10 90

                  Maize seed, other than hybrid

                  0,00

                  1005 90 00

                  Maize, other than seed (2)

                  0,00

                  1007 00 90

                  Grain sorghum, other than hybrids for sowing

                  0,00

         (1)  For goods arriving in the Union via the Atlantic Ocean or via the Suez Canal the importer may benefit, persuant to Article 2(4) of Regulation (EU) No 642/2010, from a reduction in the duty of:

                  —

                  3 EUR/t, where the port of unloading is on the Mediterranean Sea, or on the Black Sea,

                  —

                  2 EUR/t, where the port of unloading is in Denmark, Estonia, Ireland, Latvia, Lithuania, Poland, Finland, Sweden, the United Kingdom, or on the Atlantic coast of the Iberian peninsula.

         (2)  The importer may benefit from a flatrate reduction of EUR 24 per tonne where the conditions laid down in Article 3 of Regulation (EU) No 642/2010 are met.

      ANNEX II

         Factors for calculating the duties laid down in Annex I

      17.3.2011-30.3.2011

                  1.

                  Averages over the reference period referred to in Article 2(2) of Regulation (EU) No 642/2010:

                              (EUR/t)

                              Common wheat (1)

                              Maize

                              Durum wheat, high quality

                              Durum wheat, medium quality (2)

                              Durum wheat, low quality (3)

                              Barley

                              Exchange

                              Minnéapolis

                              Chicago

                              —

                              —

                              —

                              —

                              Quotation

                              241,33

                              189,21

                              —

                              —

                              —

                              —

                              Fob price USA

                              —

                              —

                              273,35

                              263,35

                              243,35

                              169,86

                              Gulf of Mexico premium

                              113,30

                              14,64

                              —

                              —

                              —

                              —

                              Great Lakes premium

                              —

                              —

                              —

                              —

                              —

                              —

                  2.

                  Averages over the reference period referred to in Article 2(2) of Regulation (EU) No 642/2010:

                              Freight costs: Gulf of Mexico–Rotterdam:

                              18,39 EUR/t

                              Freight costs: Great Lakes–Rotterdam:

                              — EUR/t

         (1)  Premium of 14 EUR/t incorporated (Article 5(3) of Regulation (EU) No 642/2010).

         (2)  Discount of 10 EUR/t (Article 5(3) of Regulation (EU) No 642/2010).

         (3)  Discount of 30 EUR/t (Article 5(3) of Regulation (EU) No 642/2010).


title: Commission Implementing Regulation (EU) No 11/2013 of 9 January 2013 amending the representative prices and additional import duties for certain products in the sugar sector fixed by Implementing Regulation (EU) No 892/2012 for the 2012/13 marketing year

text:
               10.1.2013

               EN

               Official Journal of the European Union

               L 5/7

         COMMISSION IMPLEMENTING REGULATION (EU) No 11/2013
   of 9 January 2013
   amending the representative prices and additional import duties for certain products in the sugar sector fixed by Implementing Regulation (EU) No 892/2012 for the 2012/13 marketing year
   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 36(2), second subparagraph, second sentence thereof,
   Whereas:

               (1)

               The representative prices and additional duties applicable to imports of white sugar, raw sugar and certain syrups for the 2012/13 marketing year are fixed by Commission Implementing Regulation (EU) No 892/2012 (3). Those prices and duties were last amended by Commission Implementing Regulation (EU) No 2/2013 (4).

               (2)

               The data currently available to the Commission indicate that those amounts should be amended in accordance with Article 36 of Regulation (EC) No 951/2006.

               (3)

               Given the need to ensure that this measure applies as soon as possible after the updated data have been made available, this Regulation should enter into force on the day of its publication,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The representative prices and additional duties applicable to imports of the products referred to in Article 36 of Regulation (EC) No 951/2006, as fixed by Implementing Regulation (EU) No 892/2012 for the 2012/13 marketing year, are hereby amended as set out in the Annex hereto.
   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, 9 January 2013.

            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 263, 28.9.2012, p. 37.

      (4)  OJ L 1, 4.1.2013, p. 15.

      ANNEX

         Amended representative prices and additional import duties applicable to white sugar, raw sugar and products covered by CN code 1702 90 95 from 10 January 2013

                  (EUR)

                  CN code

                  Representative price per 100 kg net of the product concerned

                  Additional duty per 100 kg net of the product concerned

                  1701 12 10 (1)

                  33,36

                  1,14

                  1701 12 90 (1)

                  33,36

                  4,60

                  1701 13 10 (1)

                  33,36

                  1,28

                  1701 13 90 (1)

                  33,36

                  4,90

                  1701 14 10 (1)

                  33,36

                  1,28

                  1701 14 90 (1)

                  33,36

                  4,90

                  1701 91 00 (2)

                  38,70

                  5,88

                  1701 99 10 (2)

                  38,70

                  2,73

                  1701 99 90 (2)

                  38,70

                  2,73

                  1702 90 95 (3)

                  0,39

                  0,29

         (1)  For the standard quality defined in point III of Annex IV to Regulation (EC) No 1234/2007.

         (2)  For the standard quality defined in point II of Annex IV to Regulation (EC) No 1234/2007.

         (3)  Per 1 % sucrose content.