title: Commission Implementing Regulation (EU) No 704/2011 of 20 July 2011 approving the active substance azimsulfuron, 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:
               21.7.2011

               EN

               Official Journal of the European Union

               L 190/38

         COMMISSION IMPLEMENTING REGULATION (EU) No 704/2011
   of 20 July 2011
   approving the active substance azimsulfuron, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) and Article 78(2) thereof,
   Whereas:

               (1)

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

               (2)

               The approval of azimsulfuron, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (4), expires on 31 December 2011. A notification was submitted in accordance with Article 4 of Regulation (EC) No 737/2007 for the renewal of the inclusion of azimsulfuron in Annex I to Directive 91/414/EEC within the time period provided for in that Article.

               (3)

               That notification was found to be admissible by Commission Decision 2008/656/EC of 28 July 2008 on the admissibility of the notifications concerning the renewal of the inclusion in Annex I to Council Directive 91/414/EEC of the active substances azimsulfuron, azoxystrobin, fluroxypyr, imazalil, kresoxim-methyl, prohexadione and spiroxamine, and establishing the list of the notifiers concerned (5).

               (4)

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

               (5)

               The rapporteur Member State prepared an assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 1 June 2009. In addition to the assessment of the active substance, that report includes a list of the studies the rapporteur Member State relied on for its assessment.

               (6)

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

               (7)

               At the request of the Commission, the assessment report was peer reviewed by the Member States and the Authority. The Authority presented its conclusion on the peer review of the risk assessment of azimsulfuron (6) to the Commission on 12 March 2010. The assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 17 June 2011 in the format of the Commission review report for azimsulfuron.

               (8)

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

               (9)

               In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions not provided for in the first inclusion in Annex I to Directive 91/414/EEC.

               (10)

               Based on the review report, which points out that the manufacturing impurity phenol is of toxicological concern, a maximum level of 2 g/kg should, however, be set for that impurity in the technical material.

               (11)

               From the new data submitted, it appears that azimsulfuron and its degradation products in aqueous photolysis may cause risks for aquatic organisms. Without prejudice to the conclusion that azimsulfuron should be approved, it is, in particular, appropriate to require further confirmatory information.

               (12)

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

               (13)

               Without prejudice to the obligations provided for by Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009 the following should, however, apply. Member States should be allowed a period of 6 months after approval to review authorisations of plant protection products containing azimsulfuron. 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.

               (14)

               The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (7) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

               (15)

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

               (16)

               In the interest of clarity, Commission Directive 2010/54/EU of 20 August 2010 amending Annex I to Council Directive 91/414/EEC to renew the inclusion of azimsulfuron as active substance (8) should be repealed.

               (17)

               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 azimsulfuron, 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 azimsulfuron as an active substance by 30 June 2012.
   By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in Part B of the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Article 13(1) to (4) of Directive 91/414/EEC and Article 62 of Regulation (EC) No 1107/2009.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing azimsulfuron as either the only active substance or as one of several active substances all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 December 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account Part B of the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product still 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 azimsulfuron as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or

               (b)

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

         Article 3
   Amendments to Implementing Regulation (EU) No 540/2011
   The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
   Article 4
   Repeal
   Directive 2010/54/EU is repealed.
   Article 5
   Entry into force and date of application
   This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   It shall apply from 1 January 2012.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 20 July 2011.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  OJ L 230, 19.8.1991, p. 1.

      (3)  OJ L 169, 29.6.2007, p. 10.

      (4)  OJ L 153, 11.6.2011, p. 1.

      (5)  OJ L 214, 9.8.2008, p. 70.

      (6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance azimsulfuron. EFSA Journal 2010; 8(3):1554. [61 pp.]. doi:10.2903/j.efsa.2010.1554. Available online: www.efsa.europa.eu

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

      (8)  OJ L 220, 21.8.2010, p. 63.

      ANNEX I

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  Azimsulfuron
                  CAS No 120162-55-2
                  CIPAC No 584

                  1-(4,6-dimethoxypyrimidin-2-yl)-3-[1-methyl-4-(2-methyl-2H-tetrazol-5-yl)-pyrazol-5-ylsulfonyl]-urea

                  ≥ 980 g/kg
                  maximum level of the impurity phenol 2 g/kg

                  1 January 2012

                  31 December 2021

                  PART A
                  Only uses as herbicide may be authorised.
                  Aerial applications may not be authorised.
                  PART B
                  For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on azimsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              (1)

                              the protection of non-target plants;

                              (2)

                              the potential for groundwater contamination, when the active substance is applied in vulnerable scenarios and/or climatic conditions;

                              (3)

                              the protection of aquatic organisms.

                        Member States shall ensure that the conditions of authorisation include risk mitigation measures, where appropriate (e.g. buffer zones, in rice cultivation minimum holding periods for water prior to discharge).
                  The notifier shall submit confirmatory information as regards:

                              (a)

                              the risk assessment on aquatic organisms;

                              (b)

                              the identification of the degradation products in the aqueous photolysis of the substance.

                        The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.

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

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

                  (1)

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

                  (2)

                  in Part B, the following entry is added:

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity (1)

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‘3

                              Azimsulfuron
                              CAS No 120162-55-2
                              CIPAC No 584

                              1-(4,6-dimethoxypyrimidin-2-yl)-3-[1-methyl-4-(2-methyl-2H-tetrazol-5-yl)-pyrazol-5-ylsulfonyl]-urea

                              ≥ 980 g/kg
                              maximum level of the impurity phenol 2 g/kg

                              1 January 2012

                              31 December 2021

                              PART A
                              Only uses as herbicide may be authorised.
                              Aerial applications may not be authorised.
                              PART B
                              For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on azimsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.
                              In this overall assessment Member States shall pay particular attention to:

                                          (1)

                                          the protection of non-target plants;

                                          (2)

                                          the potential for groundwater contamination, when the active substance is applied in vulnerable scenarios and/or climatic conditions;

                                          (3)

                                          the protection of aquatic organisms.

                                    Member States shall ensure that the conditions of authorisation include risk mitigation measures, where appropriate (e.g. buffer zones, in rice cultivation minimum holding periods for water prior to discharge).
                              The notifier shall submit confirmatory information as regards:

                                          (a)

                                          the risk assessment on aquatic organisms;

                                          (b)

                                          the identification of the degradation products in the aqueous photolysis of the substance.

                                    The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.’

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


title: Commission Implementing Regulation (EU) No 571/2012 of 28 June 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances aluminium silicate, hydrolysed proteins and 1,4-diaminobutane (putrescine)  Text with EEA relevance

text:
               29.6.2012

               EN

               Official Journal of the European Union

               L 169/46

         COMMISSION IMPLEMENTING REGULATION (EU) No 571/2012
   of 28 June 2012
   amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances aluminium silicate, hydrolysed proteins and 1,4-diaminobutane (putrescine)
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2)(c) thereof,
   Whereas:

               (1)

               The active substances aluminium silicate, hydrolysed proteins and 1,4-diaminobutane (putrescine) were included in Annex I to Council Directive 91/414/EEC (2) by Commission Directive 2008/127/EC (3) in accordance with the procedure provided for in Article 24b of Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (4). Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, these substances are deemed to have been approved under that Regulation and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (5).

               (2)

               In accordance with Article 25a of Regulation (EC) No 2229/2004, the European Food Safety Authority, hereinafter ‘the Authority’, presented to the Commission its views on the draft review reports for aluminium silicate (6), hydrolysed proteins (7) and 1,4-diaminobutane (putrescine) (8) on 16 December 2011. The draft review reports and the views of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 1 June 2012 in the format of the Commission review reports for aluminium silicate, hydrolysed proteins and 1,4-diaminobutane (putrescine).

               (3)

               The Authority communicated its views on aluminium silicate, hydrolysed proteins and 1,4-diaminobutane (putrescine) to the notifiers, and the Commission invited them to submit comments on the review reports.

               (4)

               It is confirmed that the active substances aluminium silicate, hydrolysed proteins and 1,4-diaminobutane (putrescine) are to be deemed to have been approved under Regulation (EC) No 1107/2009.

               (5)

               In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to amend the conditions of approval of aluminium silicate, hydrolysed proteins and 1,4-diaminobutane (putrescine). It is, in particular, appropriate to require further confirmatory information as regards aluminium silicate and hydrolysed proteins. At the same time certain technical adaptations should be made, in particular the name of the active substance ‧putrescin (1,4-diaminobutane)‧ should be replaced by ‧1,4-diaminobutane (putrescine)‧. The Annex to Regulation (EU) No 540/2011 should therefore be amended accordingly.

               (6)

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

               (7)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 November 2012.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 28 June 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009,p. 1.

      (2)  OJ L 230, 19.8.1991, p. 1.

      (3)  OJ L 344, 20.12.2008, p. 89.

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

      (5)  OJ L 153, 11.6.2011, p. 1.

      (6)  Conclusion on the peer review of the pesticide risk assessment of the active substance aluminium silicate. EFSA Journal 2012; 10(1):2517. Available online: www.efsa.europa.eu/efsajournal.

      (7)  Conclusion on the peer review of the pesticide risk assessment of the active substance hydrolysed proteins. EFSA Journal 2012; 10(2):2545. Available online: www.efsa.europa.eu/efsajournal.

      (8)  Conclusion on the peer review of the pesticide risk assessment of the active substance 1,4-diaminobutane (putrescine). EFSA Journal 2012;10(1):2516. Available online: www.efsa.europa.eu/efsajournal.

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

                  (1)

                  Row 220 on the active substance aluminium silicate is replaced by the following:

                              Number

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity (1)

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‧220

                              Aluminium silicate
                              CAS No 1332-58-7
                              CIPAC No 841

                              Not available
                              Chemical name: Aluminium silicate

                              ≥ 999,8 g/kg

                              1 September 2009

                              31 August 2019

                              PART A
                              Only uses as repellent may be authorised.
                              PART B
                              For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on aluminium silicate (SANCO/2603/08) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
                              In this overall assessment Member States shall pay particular attention to the operator safety; conditions of use shall include the application of adequate personal and respiratory protective equipment, where appropriate.
                              Conditions of use shall include, where appropriate, risk mitigation measures.
                              The Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards:

                                          (a)

                                          the specification of the technical material, as commercially manufactured, supported by appropriate analytical data;

                                          (b)

                                          the relevance of the test material used in the toxicity dossier in view of the specification of the technical material.

                                    The Member States concerned shall ensure that the applicant submits such information to the Commission by 1 May 2013.‧

                  (2)

                  Row 234 on the active substance hydrolysed proteins is replaced by the following:

                              ‧Number

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity (2)

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              234

                              Hydrolysed proteins
                              CAS No not allocated
                              CIPAC No 901

                              Not available

                              Review report (SANCO/2615/2008)

                              1 September 2009

                              31 August 2019

                              PART A
                              Only uses as attractant may be authorised. Hydrolysed proteins of animal origin must be in compliance with Regulation (EC) No 1069/2009 (3) and Commission Regulation (EU) No 142/2011 (4).
                              PART B
                              For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on hydrolysed proteins (SANCO/2615/08) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
                              In this overall assessment Member States shall pay particular attention to the operator and worker safety; conditions of use shall include the application of adequate personal protective equipment, where appropriate.
                              Conditions of use shall include, where appropriate, risk mitigation measures.
                              The Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards:

                                          (a)

                                          the specifications of the technical material, as commercially manufactured, supported by appropriate analytical data;

                                          (b)

                                          the risk to aquatic organisms.

                                    The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 1 May 2013, the information set out in point (b) by 1 November 2013.

                  (3)

                  Row 245 on the active substance 1,4-diaminobutane (putrescine) is replaced by the following:

                              Number

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity (5)

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‧245

                              1,4-diaminobutane (putrescine)
                              CAS No 110-60-1
                              CIPAC No 854

                              Butane-1,4-diamine

                              ≥ 990 g/kg

                              1 September 2009

                              31 August 2019

                              PART A
                              Only uses as attractant may be authorised.
                              PART B
                              For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 1,4-diaminobutane (putrescine) (SANCO/2626/08) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
                              Conditions of use shall include, where appropriate, risk mitigation measures.‧

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

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

         (3)  OJ L 300, 14.11.2009, p. 1.

         (4)  OJ L 54, 26.2.2011, p. 1.‧

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


title: Commission Implementing Regulation (EU) No 595/2012 of 5 July 2012 approving the active substance fenpyrazamine, 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:
               6.7.2012

               EN

               Official Journal of the European Union

               L 176/46

         COMMISSION IMPLEMENTING REGULATION (EU) No 595/2012
   of 5 July 2012
   approving the active substance fenpyrazamine, 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 fenpyrazamine the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2010/150/EU (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC Austria received on 3 September 2009 an application from Sumitomo Chemical Agro Europe SAS for the inclusion of the active substance fenpyrazamine in Annex I to Directive 91/414/EEC. Decision 2010/150/EU 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 17 January 2011.

               (4)

               The draft assessment report was peer reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the peer review of the pesticide risk assessment of the active substance fenpyrazamine (4) on 6 December 2011. This draft assessment report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and was finalised on 1 June 2012 in the format of the Commission review report for fenpyrazamine.

               (5)

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

               (6)

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

               (7)

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

               (8)

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

               (9)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of active substance
   The active substance fenpyrazamine, 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 fenpyrazamine as an active substance by 30 June 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 fenpyrazamine as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 December 2012 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 fenpyrazamine as the only active substance, where necessary, amend or withdraw the authorisation by 30 June 2014 at the latest; or

               (b)

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

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

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 5 July 2012.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  OJ L 230, 19.8.1991, p. 1.

      (3)  OJ L 61, 11.3.2010, p. 35.

      (4)  EFSA Journal (2012) 10(1):2496. 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

                  Fenpyrazamine
                  CAS No 473798-59-3
                  CIPAC No 832

                  S-allyl 5-amino-2,3-dihydro-2-isopropyl-3-oxo-4-(o-tolyl)pyrazole-1-carbothioate

                  ≥ 940 g/kg

                  1 January 2013

                  31 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 fenpyrazamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
                  The purity given in this entry is based on a pilot plant production. The examining Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

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

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

                     Number

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘25

                     Fenpyrazamine
                     CAS No 473798-59-3
                     CIPAC No 832

                     S-allyl 5-amino-2,3-dihydro-2-isopropyl-3-oxo-4-(o-tolyl)pyrazole-1-carbothioate

                     ≥ 940 g/kg

                     1 January 2013

                     31 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 fenpyrazamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
                     The purity given in this entry is based on a pilot plant production. The examining Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.’

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


title: Commission Implementing Regulation (EU) No 200/2013 of 8 March 2013 approving the active substance ametoctradin, 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:
               9.3.2013

               EN

               Official Journal of the European Union

               L 67/1

         COMMISSION IMPLEMENTING REGULATION (EU) No 200/2013
   of 8 March 2013
   approving the active substance ametoctradin, 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 ametoctradin the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2009/535/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the Netherlands received on 26 September 2008 an application from BASF SE for the inclusion of the active substance ametoctradin in Annex I to Directive 91/414/EEC. Decision 2009/535/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 15 September 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 ametoctradin (4) on 18 October 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 was finalised on 1 February 2013 in the format of the Commission review report for ametoctradin.

               (5)

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

               (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 ametoctradin. 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 ametoctradin, 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 ametoctradin as an active substance by 31 January 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 ametoctradin 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 July 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 ametoctradin as the only active substance, where necessary, amend or withdraw the authorisation by 31 January 2015 at the latest; or

               (b)

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

         Article 3
   Amendments to Implementing Regulation (EU) No 540/2011
   The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
   Article 4
   Entry into force and 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 August 2013.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 8 March 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 179, 10.7.2009, p. 66.

      (4)  EFSA Journal 2012; 10(11):2921. 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

                  Ametoctradin
                  CAS No 865318-97-4
                  CIPAC No 818

                  5-ethyl-6-octyl [1,2,4]triazolo[1,5-a] pyrimidin-7-amine

                  ≥ 980 g/kg
                  The impurities amitrole and o-xylene are of toxicological relevance and shall not exceed 50 g/kg and 2 g/kg respectively in the technical material.

                  1 August 2013

                  31 July 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 ametoctradin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to the leakage of metabolite M650F04 (2) to groundwater under vulnerable conditions.
                  Conditions of use shall include risk mitigation measures, where appropriate.

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

         (2)  7-amino-5-ethyl[1,2,4]triazolo[1,5-a]pyrimidine-6-carboxylic acid.

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

                     ‘33

                     Ametoctradin
                     CAS No 865318-97-4
                     CIPAC No 818

                     5-ethyl-6-octyl [1,2,4]triazolo[1,5-a] pyrimidin-7-amine

                     ≥ 980 g/kg
                     The impurities amitrole and o-xylene are of toxicological relevance and shall not exceed 50 g/kg and 2 g/kg respectively in the technical material.

                     1 August 2013

                     31 July 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 ametoctradin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to the leakage of metabolite M650F04 (1) to groundwater under vulnerable conditions.
                     Conditions of use shall include risk mitigation measures, where appropriate.

         (1)  7-amino-5-ethyl[1,2,4]triazolo[1,5-a]pyrimidine-6-carboxylic acid.’


title: Commission Implementing Regulation (EU) No 1316/2011 of 15 December 2011 on the minimum customs duty to be fixed in response to the second partial invitation to tender within the tendering procedure opened by Implementing Regulation (EU) No 1239/2011

text:
               16.12.2011

               EN

               Official Journal of the European Union

               L 334/16

         COMMISSION IMPLEMENTING REGULATION (EU) No 1316/2011
   of 15 December 2011
   on the minimum customs duty to be fixed in response to the second partial invitation to tender within the tendering procedure opened by Implementing Regulation (EU) No 1239/2011
   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), and in particular Article 187, in conjunction with Article 4, thereof
   Whereas:

               (1)

               Commission Implementing Regulation (EU) No 1239/2011 (2) opened a standing invitation to tender for the 2011/12 marketing year for imports of sugar of CN code 1701 at a reduced customs duty.

               (2)

               In accordance with Article 6 of Implementing Regulation (EU) No 1239/2011, the Commission is to decide, in the light of the tenders received in response to a partial invitation to tender, either to fix a minimum customs duty or not to fix a minimum customs duty per eight digit CN code.

               (3)

               On the basis of the tenders received for the second partial invitation to tender, a minimum customs duty should be fixed for certain eight digit codes for sugar falling within CN code 1701 and no minimum customs duty should be fixed for the other eight digit codes for sugar falling within that CN code.

               (4)

               In order to give a rapid signal to the market and to ensure efficient management of the measure, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union.

               (5)

               The Management Committee for the Common Organisation of Agricultural Markets has not delivered an opinion within the time limit set by its Chair,

         HAS ADOPTED THIS REGULATION:
   Article 1
   For the second partial invitation to tender within the tendering procedure opened by Implementing Regulation (EU) No 1239/2011, in respect of which the time limit for the submission of tenders expired on 14 December 2011, a minimum customs duty has been fixed, or has not been fixed, as set out in the Annex to this Regulation for the eight digit codes for sugar falling within CN code 1701.
   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, 15 December 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 318, 1.12.2011, p. 4.

      ANNEX

         Minimum customs duties

                  (EUR/tonne)

                  Eight digit CN code

                  Minimum customs duty

                  1

                  2

                  1701 11 10

                  263,50

                  1701 11 90

                  —

                  1701 12 10

                  X

                  1701 12 90

                  X

                  1701 91 00

                  X

                  1701 99 10

                  —

                  1701 99 90

                  X

                              (—)

                              no minimum customs duty fixed (all offers rejected)

                              (X)

                              no offers


title: Commission Implementing Regulation (EU) No 765/2013 of 29 July 2013 entering a name in the register of protected designations of origin and protected geographical indications (Walbecker Spargel (PGI))

text:
               9.8.2013

               EN

               Official Journal of the European Union

               L 214/1

         COMMISSION IMPLEMENTING REGULATION (EU) No 765/2013
   of 29 July 2013
   entering a name in the register of protected designations of origin and protected geographical indications (Walbecker Spargel (PGI))
   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)

               Regulation (EU) No 1151/2012 repealed and replaced Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (2).

               (2)

               Pursuant to Article 6(2) of Regulation (EC) No 510/2006, Germany’s application to register the name ‘Walbecker Spargel’ was published in the Official Journal of the European Union
                   (3).

               (3)

               As no statement of objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, the name ‘Walbecker Spargel’ should therefore be entered in the register,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The name contained in the Annex to this Regulation is hereby entered in the register.
   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, 29 July 2013.

            For the Commission, On behalf of the President,
         Dacian CIOLOȘ

            Member of the Commission

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

      (2)  OJ L 93, 31.3.2006, p. 12.

      (3)  OJ C 288, 25.9.2012, p. 13.

      ANNEX
      Agricultural products intended for human consumption listed in Annex I to the Treaty:

         Class 1.6.   Fruit, vegetables and cereals, fresh or processed

      GERMANY
      Walbecker Spargel (PGI)


title: Commission Implementing Regulation (EU) No 201/2013 of 8 March 2013 amending Implementing Regulations (EU) No 788/2011 and (EU) No 540/2011 as regards an extension of the uses for which the active substance fluazifop-P is approved  Text with EEA relevance

text:
               9.3.2013

               EN

               Official Journal of the European Union

               L 67/6

         COMMISSION IMPLEMENTING REGULATION (EU) No 201/2013
   of 8 March 2013
   amending Implementing Regulations (EU) No 788/2011 and (EU) No 540/2011 as regards an extension of the uses for which the active substance fluazifop-P is approved
   (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 Implementing Regulation (EU) No 788/2011 of 5 August 2011 approving the active substance fluazifop-P, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and Commission Decision 2008/934/EC (2) the active substance fluazifop-P was approved. The approval included the special provision ‘only uses as herbicide for orchards (basal application) with one application every year may be authorised’.

               (2)

               On 29 June 2011 Syngenta Crop Protection AG, at whose request fluazifop-P had been approved, submitted an application for an amendment to the conditions of approval of the active substance fluazifop-P to allow uses as a herbicide to be authorised without restriction. That application was accompanied by information relating to the requested extension of uses. It was submitted to France, which had been designated rapporteur Member State by Commission Regulation (EC) No 1490/2002 (3).

               (3)

               France assessed the information submitted by the applicant and prepared an addendum to the draft assessment report. It submitted that addendum to the Commission, with a copy to the European Food Safety Authority, hereinafter ‘the Authority’, on 2 April 2012.

               (4)

               The Authority circulated the addendum to the applicant and the Member States, with the exception of the rapporteur Member State, and made it available to the public, allowing a period of 60 days for the submission of written comments.

               (5)

               The Authority organised an expert consultation as regards mammalian toxicology.

               (6)

               Taking into account the addendum to the draft assessment report, the Authority adopted its conclusion on fluazifop-P on 18 October 2012 (4), as regards its unrestricted use as a herbicide. It communicated that conclusion to the applicant, the Member States and the Commission and made it available to the public. The draft assessment report, the addendum thereto and that conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 1 February 2013 in the format of the Commission review report for fluazifop-P. The applicant was given the possibility to submit comments on the review report.

               (7)

               It has appeared from the information submitted by the applicant that allowing uses as a herbicide to be authorised without restriction does not cause any risks in addition to those already taken into account in Implementing Regulation (EU) No 788/2011 and in the Commission review report on which that Implementing Regulation was based.

               (8)

               On the basis of the review report, as finalised on 1 February 2013 and of the conclusion by the Authority adopted on 18 October 2012, it is appropriate to extend the approval of fluazifop-P to cover uses as a herbicide without restriction.

               (9)

               In order to take into account the remaining uncertainty on the calculation of the degradation half time of the metabolite Compound X (5) Member States should pay particular attention to consumer safety as regards the occurrence in groundwater of that metabolite.

               (10)

               Implementing Regulations (EU) No 788/2011 and Commission Implementing Regulation (EU) No 540/2011 (6) should therefore 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
   Amendment to Implementing Regulation (EU) No 788/2011
   Annex I to Implementing Regulation (EU) No 788/2011 is amended in accordance with Annex I to this Regulation.
   Article 2
   Amendment to Implementing Regulation (EU) No 540/2011
   The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
   Article 3
   Entry into force
   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, 8 March 2013.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  OJ L 203, 6.8.2011, p. 21.

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

      (4)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance fluazifop-P. EFSA Journal 2012;10(11):2945. [18 pp.] doi:10.2903/j.efsa.2012.2945. Available online: www.efsa.europa.eu/efsajournal

      (5)  5-(trifluoromethyl)-2(1H)-pyridinone.

      (6)  OJ L 153, 11.6.2011, p. 1.

      ANNEX I
      The column ‘Specific provisions’ in Annex I to Implementing Regulation (EU) No 788/2011 is replaced by the following:

         ‘PART A
         Only uses as herbicide may be authorised.
         PART B
         For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluazifop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013, shall be taken into account.
         In this overall assessment Member States shall:

                     —

                     pay particular attention to consumer safety as regards the occurrence in groundwater of the metabolite compound X (1);

                     —

                     pay particular attention to operator safety and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;

                     —

                     pay particular attention to the protection of surface water and groundwater in vulnerable zones;

                     —

                     pay particular attention to the risk for non-target plants.

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

                     (1)

                     the specification of the technical material, as commercially manufactured, including information on the relevance of the impurity R154719;

                     (2)

                     the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies;

                     (3)

                     the potential long-term risk to herbivorous mammals;

                     (4)

                     the fate and behaviour in the environment of the metabolite compounds X (1) and IV (2);

                     (5)

                     the potential risk to fish and aquatic invertebrates for the metabolite compound IV (2).

               The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) and (2) by 30 June 2012 and the information set out in points (3), (4) and (5) by 31 December 2013.

         (1)  5-(trifluoromethyl)-2(1H)-pyridinone.

         (2)  4-{[5-(trifluoromethyl)-2-pyridinyl]oxy}phenol..

      ANNEX II
      The column ‘Specific provisions’ of row 15, fluazifop-P, of Part B of the Annex to Implementing Regulation (EU) No 540/2011 is replaced by the following:

         ‘PART A
         Only uses as herbicide may be authorised.
         PART B
         For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluazifop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013, shall be taken into account.
         In this overall assessment Member States shall:

                     —

                     pay particular attention to consumer safety as regards the occurrence in groundwater of the metabolite compound X (1);

                     —

                     pay particular attention to operator safety and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;

                     —

                     pay particular attention to the protection of surface water and groundwater in vulnerable zones;

                     —

                     pay particular attention to the risk for non-target plants.

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

                     (1)

                     the specification of the technical material, as commercially manufactured, including information on the relevance of the impurity R154719;

                     (2)

                     the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies;

                     (3)

                     the potential long-term risk to herbivorous mammals;

                     (4)

                     the fate and behaviour in the environment of the metabolite compounds X (1) and IV (2);

                     (5)

                     the potential risk to fish and aquatic invertebrates for the metabolite compound IV (2).

               The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) and (2) by 30 June 2012 and the information set out in points (3), (4) and (5) by 31 December 2013.

         (1)  5-(trifluoromethyl)-2(1H)-pyridinone.

         (2)  4-{[5-(trifluoromethyl)-2-pyridinyl]oxy}phenol.


title: Commission Implementing Regulation (EU) No 192/2014 of 27 February 2014 approving the active substance 1,4-dimethylnaphthalene, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011  Text with EEA relevance

text:
               28.2.2014

               EN

               Official Journal of the European Union

               L 59/20

      COMMISSION IMPLEMENTING REGULATION (EU) No 192/2014
   of 27 February 2014
   approving the active substance 1,4-dimethylnaphthalene, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) and Article 78(2) thereof,
   Whereas:

               (1)

               In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For 1,4-dimethylnaphthalene the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2010/244/EU (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the Netherlands received on 25 June 2009 an application from DormFresh Ltd for the inclusion of the active substance 1,4-dimethylnaphthalene in Annex I to Directive 91/414/EEC. Decision 2010/244/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 21 March 2012.

               (4)

               The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance 1,4-dimethylnaphthalene (4) on 16 May 2013. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 13 December 2013 in the format of the Commission review report for 1,4-dimethylnaphthalene.

               (5)

               It has appeared from the various examinations made that plant protection products containing 1,4-dimethylnaphthalene 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 1,4-dimethylnaphthalene.

               (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 1,4-dimethylnaphthalene. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

               (9)

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

               (10)

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

               (11)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of active substance
   The active substance 1,4-dimethylnaphthalene, 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 1,4-dimethylnaphthalene as an active substance by 31 December 2014.
   By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing 1,4-dimethylnaphthalene as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 30 June 2014 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
   Following that determination Member States shall:

               (a)

               in the case of a product containing 1,4-dimethylnaphthalene as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or

               (b)

               in the case of a product containing 1,4-dimethylnaphthalene as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

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

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 27 February 2014.

            For the Commission

            The President

         José Manuel BARROSO

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

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

      (3)  Commission Decision 2010/244/EU of 26 April 2010 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of 1,4-dimethylnaphthalene and cyflumetofen in Annex I to Council Directive 91/414/EEC (OJ L 107, 29.4.2010, p. 22).

      (4)  EFSA Journal 2013; 11(6):3229. Available online: www.efsa.europa.eu

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

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

      ANNEX I

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  1,4-dimethylnaphthalene
                  CAS No 571-58-4
                  CIPAC No 822

                  1,4-dimethylnaphthalene

                  ≥ 980 g/kg

                  1 July 2014

                  30 June 2024

                  For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 1,4-dimethylnaphthalene, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              (a)

                              the protection of operators and of workers at re-entry and during inspection of the warehouse;

                              (b)

                              the risk to aquatic organisms and fish-eating mammals the active substance is discharged from warehouses into air and surface water without further treatment.

                        Conditions of use shall include risk mitigation measures, where appropriate.
                  The applicant shall submit confirmatory information as regards the residue definition for the active substance.
                  The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.

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

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

                     Number

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘68

                     1,4-dimethylnaphthalene
                     CAS No 571-58-4
                     CIPAC No 822

                     1,4-dimethylnaphthalene

                     ≥ 980 g/kg

                     1 July 2014

                     30 June 2024

                     For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 1,4-dimethylnaphthalene, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 (a)

                                 the protection of operators and of workers at re-entry and during inspection of the warehouse;

                                 (b)

                                 the risk to aquatic organisms and fish-eating mammals the active substance is discharged from warehouses into air and surface water without further treatment.

                           Conditions of use shall include risk mitigation measures, where appropriate.
                     The applicant shall submit confirmatory information as regards the residue definition for the active substance.
                     The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.’

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


title: Commission Implementing Regulation (EU) 2017/1596 of 21 September 2017 on the minimum selling price for skimmed milk powder for the 12th partial invitation to tender within the tendering procedure opened by Implementing Regulation (EU) 2016/2080

text:
               22.9.2017

               EN

               Official Journal of the European Union

               L 244/8

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/1596
   of 21 September 2017
   on the minimum selling price for skimmed milk powder for the 12th partial invitation to tender within the tendering procedure opened by Implementing Regulation (EU) 2016/2080
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),
   Having regard to Commission Implementing Regulation (EU) 2016/1240 of 18 May 2016 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council with regard to public intervention and aid for private storage (2), and in particular Article 32 thereof,
   Whereas:

               (1)

               Commission Implementing Regulation (EU) 2016/2080 (3) has opened the sale of skimmed milk powder by a tendering procedure.

               (2)

               In the light of the tenders received for the 12th partial invitation to tender, a minimum selling price should not be fixed.

               (3)

               The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

         HAS ADOPTED THIS REGULATION:
   Article 1
   For the 12th partial invitation to tender for the selling of skimmed milk powder within the tendering procedure opened by Implementing Regulation (EU) 2016/2080, in respect of which the period during which tenders were to be submitted ended on 19 September 2017, a minimum selling price has not been fixed.
   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, 21 September 2017.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General

            Directorate-General for Agriculture and Rural Development

      (1)  OJ L 347, 20.12.2013, p. 671.

      (2)  OJ L 206, 30.7.2016, p. 71.

      (3)  Commission Implementing Regulation (EU) 2016/2080 of 25 November 2016 opening the sale of skimmed milk powder by a tendering procedure (OJ L 321, 29.11.2016, p. 45).