title: Commission Implementing Regulation (EU) 2015/2105 of 20 November 2015 approving the active substance flumetralin, as a candidate for substitution, 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:
               21.11.2015

               EN

               Official Journal of the European Union

               L 305/31

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/2105
   of 20 November 2015
   approving the active substance flumetralin, as a candidate for substitution, 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 24 in conjunction with Article 13(2) and Article 78(2) thereof,
   Whereas:

               (1)

               In accordance with Article 7(1) of Regulation (EC) No 1107/2009, Hungary received on 3 April 2012 an application from Exponent International Ltd on behalf of Syngenta Crop Protection AG for the approval of the active substance flumetralin. In accordance with Article 9(3) of that Regulation, Hungary, as rapporteur Member State, notified the Commission on 28 September 2012 of the admissibility of the application.

               (2)

               On 30 October 2013 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the European Food Safety Authority (hereinafter ‘the Authority’) assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

               (3)

               The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report in September 2014.

               (4)

               On 20 November 2014 the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance flumetralin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 (2). The Authority made its conclusion available to the public.

               (5)

               The applicant was given the possibility to submit comments on the review report.

               (6)

               On 29 May 2015, the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for flumetralin and a draft Regulation providing that flumetralin is approved.

               (7)

               It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. Those approval criteria are therefore deemed to be satisfied.

               (8)

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

               (9)

               The Commission however considers that flumetralin is a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Flumetralin is a persistent and toxic substance in accordance with points 3.7.2.1 and 3.7.2.3 respectively, of Annex II to Regulation (EC) No 1107/2009, given that the half-life in fresh water is greater than 40 days and the long-term no-observed effect concentration for freshwater organisms is less than 0,01 mg/L. Flumetralin therefore fulfils the condition set in the second indent of point 4 of Annex II to Regulation (EC) No 1107/2009.

               (10)

               It is therefore appropriate to approve flumetralin as a candidate for substitution.

               (11)

               In accordance with Article 24(2) of Regulation (EC) No 1107/2009, candidates for substitution are to be listed separately in the Regulation referred to in Article 13(4) of Regulation (EC) No 1107/2009. It is therefore appropriate to add a Part E in the Annex to Commission Implementing Regulation (EU) No 540/2011 (3). That Regulation should therefore be amended accordingly.

               (12)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of the active substance as a candidate for substitution
   The active substance flumetralin is approved as set out in Annex I as a candidate for substitution.
   Article 2
   Amendments to Implementing Regulation (EU) No 540/2011
   1.   In Article 1 of Implementing Regulation (EU) No 540/2011 the second paragraph is replaced by the following paragraph:

      ‘The active substances approved under Regulation (EC) No 1107/2009 are as set out in Part B of the Annex to this Regulation. The basic substances approved under Regulation (EC) No 1107/2009 are as set out in Part C of the Annex to this Regulation. The low-risk active substances approved under Regulation (EC) No 1107/2009 are as set out in Part D of the Annex to this Regulation. The candidates for substitution approved under Regulation (EC) No 1107/2009 are as set out in Part E of the Annex to this Regulation.’

   2.   The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
   Article 3
   Entry into force
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 20 November 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  EFSA Journal 2014;12(10):3816. Available online: www.efsa.europa.eu

      (3)  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

                  Flumetralin
                  CAS No 62924-70-3
                  CIPAC No 971

                     N-(2-chloro-6-fluorobenzyl)-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine

                  980 g/kg
                  The impurity Nitrosamine (calculated as nitroso-dimethylamine) shall not exceed 0,001 g/kg in the technical material.

                  11 December 2015

                  11 December 2022

                  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 flumetralin, and in particular Appendices I and II thereof, shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              (a)

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

                              (b)

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

                              (c)

                              the risk to herbivorous mammals;

                              (d)

                              the risk to aquatic organisms.

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

                              1.

                              the technical specification of the active substance as manufactured (based on commercial scale production);

                              2.

                              the compliance of the toxicity batches with the confirmed technical specification.

                        The applicant shall submit to the Commission, the Member States and the Authority the information referred to in points 1 and 2 by 11 June 2016.

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

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

         ‘PART E

            Candidates for substitution

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     1

                     Flumetralin
                     CAS No 62924-70-3
                     CIPAC No 971

                        N-(2-chloro-6-fluorobenzyl)-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine

                     980 g/kg
                     The impurity Nitrosamine (calculated as nitroso-dimethylamine) shall not exceed 0,001 g/kg in the technical material.

                     11 December 2015

                     11 December 2022

                     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 flumetralin, and in particular Appendices I and II thereof, shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 (a)

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

                                 (b)

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

                                 (c)

                                 the risk to herbivorous mammals;

                                 (d)

                                 the risk to aquatic organisms.

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

                                 1.

                                 the technical specification of the active substance as manufactured (based on commercial scale production);

                                 2.

                                 the compliance of the toxicity batches with the confirmed technical specification.

                           The applicant shall submit to the Commission, the Member States and the Authority the information referred to in points 1 and 2 by 11 June 2016.

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


title: Commission Implementing Regulation (EU) No 1/2012 of 3 January 2012 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               4.1.2012

               EN

               Official Journal of the European Union

               L 1/1

         COMMISSION IMPLEMENTING REGULATION (EU) No 1/2012
   of 3 January 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, 3 January 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

                  MA

                  49,9

                  TR

                  97,9

                  ZZ

                  73,9

                  0707 00 05

                  TR

                  130,0

                  ZZ

                  130,0

                  0709 93 10

                  MA

                  36,2

                  TR

                  145,4

                  ZZ

                  90,8

                  0805 10 20

                  CL

                  33,0

                  MA

                  68,8

                  TR

                  68,9

                  ZZ

                  56,9

                  0805 20 10

                  MA

                  70,8

                  ZZ

                  70,8

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

                  IL

                  74,8

                  TR

                  93,2

                  ZZ

                  84,0

                  0805 50 10

                  AR

                  53,1

                  TR

                  50,4

                  ZZ

                  51,8

                  0808 10 80

                  CA

                  122,1

                  US

                  120,9

                  ZA

                  128,3

                  ZZ

                  123,8

                  0808 30 90

                  CN

                  35,5

                  ZZ

                  35,5

         (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’.