title: Commission Implementing Regulation (EU) No 1037/2012 of 7 November 2012 approving the active substance isopyrazam, 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:
               8.11.2012

               EN

               Official Journal of the European Union

               L 308/15

         COMMISSION IMPLEMENTING REGULATION (EU) No 1037/2012
   of 7 November 2012
   approving the active substance isopyrazam, 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 isopyrazam the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2010/132/EU (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 25 November 2008 an application from Syngenta Crop Protection AG for the inclusion of the active substance isopyrazam in Annex I to Directive 91/414/EEC. Decision 2010/132/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 4 May 2010.

               (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 isopyrazam (4) on 27 February 2012. The draft assessment report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and was finalised on 28 September 2012 in the format of the Commission review report for isopyrazam.

               (5)

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

               (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)

               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 isopyrazam. 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 isopyrazam, 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 isopyrazam as an active substance by 30 September 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 isopyrazam as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 March 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 isopyrazam as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2014 at the latest; or

               (b)

               in the case of a product containing isopyrazam as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 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 April 2013.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 7 November 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 52, 3.3.2010, p. 51.

      (4)  EFSA Journal 2012; 10(3):2600. 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

                  Isopyrazam
                  CAS No 881685-58-1
                  (syn-isomer: 683777-13-1/anti-isomer: 683777-14-2)
                  CIPAC No 963

                     A mixture of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide
                  (syn-isomer – 50:50 mix of two enantiomers)

                     and

                  3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide
                  (anti-isomer– 50:50 mix of two enantiomers)
                  In a range of 78:15 % to 100:0 % syn to anti.

                  ≥ 920 g/kg
                  In a range of 78:15 % to 100:0 % syn- to anti-isomers

                  1 April 2013

                  31 March 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 isopyrazam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 September 2012 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              (a)

                              the risk to aquatic organisms;

                              (b)

                              the risk to earthworms if the substance is applied in the framework of no cultivation/minimum cultivation practices;

                              (c)

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

                        Conditions of use shall include risk mitigation measures, like the exclusion of no cultivation/minimum cultivation practices, and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate.
                  The applicant shall submit confirmatory information as regards the relevance of the metabolites CSCD 459488 and CSCD 459489 for groundwater.
                  The applicant shall submit to the Commission, the Member States and the Authority this information by 31 March 2015.

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

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

                     Number

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘27

                     Isopyrazam
                     CAS No 881685-58-1
                     (syn-isomer: 683777-13-1/anti-isomer: 683777-14-2)
                     CIPAC No 963

                        A mixture of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide
                     (syn-isomer – 50:50 mix of two enantiomers)

                        and

                     3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide
                     (anti-isomer– 50:50 mix of two enantiomers)
                     In a range of 78:15 % to 100:0 % syn to anti.

                     ≥ 920 g/kg
                     In a range of 78:15 % to 100:0 % syn- to anti-isomers

                     1 April 2013

                     31 March 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 isopyrazam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 September 2012 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 (a)

                                 the risk to aquatic organisms;

                                 (b)

                                 the risk to earthworms if the substance is applied in the framework of no cultivation/minimum cultivation practices;

                                 (c)

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

                           Conditions of use shall include risk mitigation measures, like the exclusion of no cultivation/minimum cultivation practices, and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate.
                     The applicant shall submit confirmatory information as regards the relevance of the metabolites CSCD 459488 and CSCD 459489 for groundwater.
                     The applicant shall submit to the Commission, the Member States and the Authority this information by 31 March 2015.’

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


title: Commission Implementing Regulation (EU) No 369/2012 of 27 April 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances blood meal, calcium carbide, calcium carbonate, limestone, pepper and quartz sand  Text with EEA relevance

text:
               28.4.2012

               EN

               Official Journal of the European Union

               L 116/19

         COMMISSION IMPLEMENTING REGULATION (EU) No 369/2012
   of 27 April 2012
   amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances blood meal, calcium carbide, calcium carbonate, limestone, pepper and quartz sand
   (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) thereof,
   Whereas:

               (1)

               The active substances blood meal, calcium carbide calcium carbonate, limestone, pepper and quartz sand 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 (4) 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. 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 the conclusions on the peer review for blood meal (6) on 26 September 2011 for calcium carbide (7) on 17 October 2011, for calcium carbonate (8) and for limestone (9) on 6 July 2011, for pepper dust extraction residue (10) on 4 July 2011, and for quartz sand (11) on 6 July 2011. The draft assessment reports and the conclusions 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 9 March 2012 in the format of the Commission review reports for blood meal, calcium carbide, calcium carbonate, limestone, pepper dust extraction residue and quartz sand.

               (3)

               In accordance with Article 12(2) of Regulation (EC) No 1107/2009 the Commission invited the notifiers to submit their comments on the conclusions of the Authority. Furthermore, in accordance with Article 13(1) of that Regulation, the Commission invited the notifiers to submit comments on the draft review reports for blood meal, calcium carbide, calcium carbonate, limestone, pepper dust extraction residue and quartz sand. The notifiers submitted their comments, which have been carefully examined.

               (4)

               It is confirmed that the active substances blood meal, calcium carbide, calcium carbonate, limestone, pepper and quartz sand 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 blood meal, calcium carbide, calcium carbonate, limestone, pepper and quartz sand. It is, in particular, appropriate to require further confirmatory information as regards blood meal, calcium carbonate and pepper. At the same time certain technical adaptations should be made, in particular the name of the active substance ‘pepper’ should be replaced by ‘pepper dust extraction residue‘.

               (6)

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

               (7)

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

               (8)

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

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

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 27 April 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)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance blood meal. EFSA Journal 2011; 9(10):2394. [36 pp.]. doi:10.2903/j.efsa.2011.2396. Available online: www.efsa.europa.eu/efsajournal.htm.

      (7)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance calcium carbide. EFSA Journal 2011; 9(10):2419. [48 pp.]. doi:10.2903/j.efsa.2011.2419. Available online: www.efsa.europa.eu/efsajournal.htm.

      (8)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance calcium carbonate. EFSA Journal 2011; 9(7):2298. [28 pp.] doi:10.2903/j.efsa.2011.2298. Available online: www.efsa.europa.eu/efsajournal.htm.

      (9)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance limestone. EFSA Journal 2011; 9(7):2299. [33 pp.]. doi:10.2903/j.efsa.2011.2299. Available online: www.efsa.europa.eu/efsajournal.htm.

      (10)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance pepper dust extraction residue. EFSA Journal 2011; 9(7):2285. [37 pp.]. doi:10.2903/j.efsa.2011.2285. Available online: www.efsa.europa.eu/efsajournal.htm.

      (11)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance quartz sand. EFSA Journal 2011; 9(7):2300. [40 pp.]. doi:10.2903/j.efsa.2011.2300. Available online: www.efsa.europa.eu/efsajournal.htm.

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

                  (1)

                  Row 222 on the active substance blood meal is replaced by the following:

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‧Blood meal

                              CAS No: 90989-74-5
                              CIPAC No: 909

                              Not available

                              ≥ 990 g/Kg

                              1 September 2009

                              31 August 2019

                              PART A
                              Only uses as repellent may be authorised. Blood meal must be in compliance with Regulation (EC) No 1069/2009 (1) and Regulation (EU) No 142/2011 (2).
                              PART B
                              In assessing applications to authorise plant protection products containing blood meal for uses other than with direct application localised on individual plants, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted.
                              For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on blood meal (SANCO/2604/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.
                              Conditions of use shall include, where appropriate, risk mitigation measures.
                              The notifier shall submit to the Member States, the Commission and the Authority, confirmatory information on the specification of the technical material, by 1 March 2013.

                  (2)

                  Row 223 on the active substance calcium carbide is replaced by the following:

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‧Calcium carbide

                              CAS No: 75-20-7
                              CIPAC No: 910

                              Calcium acetylide

                              ≥ 765 g/kg
                              Containing 0,08 – 0,9 g/kg Calcium Phosphide

                              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 amended review report on calcium carbide (SANCO/2605/2008) and in particular Appendices I and II thereof, as finalisedin the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.
                              Conditions of use shall include, where appropriate, risk mitigation measures.‧

                  (3)

                  Row 224 on the active substance calcium carbonate is replaced by the following:

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‧Calcium carbonate

                              CAS No: 471-34-1
                              CIPAC No: 843

                              Calcium carbonate

                              ≥ 995 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 amended review report on calcium carbonate (SANCO/2606/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.
                              Conditions of use shall include, where appropriate, risk mitigation measures.
                              The notifier shall submit confirmatory information as regards:

                                          —

                                          further data on the specification of the technical material,

                                          —

                                          analytical methods for the determination of calcium carbonate in the representative formulation and of the impurities in the technical material.

                                    These information shall be submitted to the Member States, the Commission and the Authority by 1 March 2013.‧

                  (4)

                  Row 237 on the active substance limestone is replaced by the following:

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‧Limestone

                              CAS No: 1317-65-3
                              CIPAC No: 852

                              Calcium carbonate

                              ≥ 980 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 amended review report onlimestone (SANCO/2618/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.
                              Conditions of use shall include, where appropriate, risk mitigation measures.‧

                  (5)

                  Row 239 on the active substance pepper is replaced by the following:

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‧Pepper dust extraction residue (PDER)

                              CAS No: not allocated
                              CIPAC No: not allocated

                              Steam distilled and solvent extracted Black pepper – Piper nigrum

                              It is a complex mixture of chemical substances, the component piperine as marker should be minimum 4 %

                              1 September 2009

                              31 August 2019

                              PART A
                              Only uses as repellent may be authorised.
                              PART B
                              In assessing applications to authorise plant protection products containing pepper dust extraction residue (PDER) for uses other than in home garden area, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted.
                              For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on pepper (SANCO/2620/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.
                              Conditions of use shall include, where appropriate, risk mitigation measures
                              The notifier shall submit to the Member States, the Commission and the Authority, confirmatory information on the specification of the technical material, by 1 March 2013.‧

                  (6)

                  Row 247 on the active substance quartz sand is replaced by the following:

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‧Quartz sand

                              CAS No: 14808-60-7, 7637-86-9
                              CIPAC No: 855

                              Quartz, Silicon dioxide

                              ≥ 915 g/kg
                              Maximum 0,1 % of particles of Crystalline Silica (with diameter below 50 um.)

                              1 September 2009

                              31 August 2019

                              PART A
                              Only uses as repellent may be authorised.
                              PART B
                              In assessing applications to authorise plant protection products containing quartz sand for uses other than on trees in forestry, Member States shall pay particular attention to thecriteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted.
                              For the implementation of the uniform principles of Annex VI, the conclusions of the review report on quartz sand (SANCO/2628/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                              Conditions of use shall include, where appropriate, risk mitigation measures.‧

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

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


title: Commission Implementing Regulation (EU) No 589/2012 of 4 July 2012 approving the active substance fluxapyroxad, 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:
               5.7.2012

               EN

               Official Journal of the European Union

               L 175/7

         COMMISSION IMPLEMENTING REGULATION (EU) No 589/2012
   of 4 July 2012
   approving the active substance fluxapyroxad, 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 fluxapyroxad the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2010/672/EU (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 11 December 2009 an application from BASF SE for the inclusion of the active substance fluxapyroxad in Annex I to Directive 91/414/EEC. Decision 2010/672/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 11 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 fluxapyroxad (4) on 16 December 2011. The draft assessment report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and was finalised on 1 June 2012 in the format of the Commission review report for fluxapyroxad.

               (5)

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

               (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 fluxapyroxad. 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 fluxapyroxad, 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 fluxapyroxad 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 fluxapyroxad 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 fluxapyroxad 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 fluxapyroxad 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, 4 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 290, 6.11.2010, p. 51.

      (4)  EFSA Journal 2012; 10(1):2522. 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

                  Fluxapyroxad
                  CAS No 907204-31-3
                  CIPAC No 828

                  3-(difluoromethyl)-1-methyl-N-(3′,4′,5′-trifluorobiphenyl-2-yl)pyrazole-4-carboxamide

                  ≥ 950 g/kg
                  The impurity toluene must not exceed 1 g/kg in the technical material

                  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 fluxapyroxad, 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 risk to groundwater, if the active substance is applied under vulnerable soil and/or climatic conditions.
                  Conditions of use shall include risk mitigation measures, where appropriate.
                  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

                     ‘24

                     Fluxapyroxad
                     CAS No 907204-31-3
                     CIPAC No 828

                     3-(difluoromethyl)-1-methyl-N-(3′,4′,5′-trifluorobiphenyl-2-yl)pyrazole-4-carboxamide

                     ≥ 950 g/kg
                     The impurity toluene must not exceed 1 g/kg in the technical material

                     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 fluxapyroxad, 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 risk to groundwater, if the active substance is applied under vulnerable soil and/or climatic conditions.
                     Conditions of use shall include risk mitigation measures, where appropriate.
                     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) 2015/307 of 26 February 2015 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance triclopyr  Text with EEA relevance

text:
               27.2.2015

               EN

               Official Journal of the European Union

               L 56/6

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/307
   of 26 February 2015
   amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance triclopyr
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the second alternative of Article 21(3) and Article 78(2) thereof,
   Whereas:

               (1)

               Commission Directive 2006/74/EC (2) included triclopyr as active substance in Annex I to Council Directive 91/414/EEC (3), under the condition that the Member States concerned ensure that the notifier at whose request triclopyr was included in that Annex provide further confirmatory information on the risk assessment on acute and long-term exposure for birds and mammals and the risk to aquatic organisms from exposure to the metabolite 6-chloro-2-pyridinol.

               (2)

               Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

               (3)

               The notifier submitted additional information with a view to confirm the risk assessment for birds and mammals and aquatic organisms to the rapporteur Member State Ireland within the time period provided for its submission.

               (4)

               Ireland assessed the additional information submitted by the notifier. It submitted its assessment, in the form of two addenda to the draft assessment report, to the other Member States, the Commission, and the European Food Safety Authority, hereinafter ‘the Authority’, on 25 January 2011 and on 22 November 2013.

               (5)

               The Commission considered that the additional information provided by the notifier demonstrated that an unacceptable risk for birds and mammals could not be excluded except by imposing further restrictions.

               (6)

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

               (7)

               The Commission has concluded that the further confirmatory information required has not fully been provided and that an unacceptable risk for birds and mammals cannot be excluded except by imposing further restrictions.

               (8)

               It is confirmed that the active substance triclopyr is to be deemed to have been approved under Regulation (EC) No 1107/2009. In order to minimise the exposure of birds and mammals, it is, however, appropriate to amend the conditions of use of this active substance, in particular by restricting its use.

               (9)

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

               (10)

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

               (11)

               For plant protection products containing triclopyr, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, this period should expire, at the latest, 18 months after the entry into force of this Regulation.

               (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
   Amendment to Implementing Regulation (EC) No 540/2011
   Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
   Article 2
   Transitional measures
   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary amend or withdraw existing authorisations for plant protection products containing triclopyr as active substance by 19 September 2015.
   Article 3
   Period of grace
   Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire by 19 September 2016 at the latest.
   Article 4
   Entry into force
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 26 February 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  Commission Directive 2006/74/EC of 21 August 2006 amending Council Directive 91/414/EEC to include dichlorprop-P, metconazole, pyrimethanil and triclopyr as active substances (OJ L 235, 30.8.2006, p. 17).

      (3)  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).

      (4)  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
      The column ‘Specific provisions’ of row 136, triclopyr, of Part A of the Annex to Implementing Regulation (EU) No 540/2011 is replaced by the following:

         ‘PART A
         Only uses as herbicide may be authorised. Only uses with a total application per year of maximum 480 g active substance per hectare shall 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 triclopyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 12 December 2014 shall be taken into account.
         In this overall assessment Member States:

                     —

                     shall pay particular attention to the protection of groundwater under vulnerable conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated in vulnerable zones, where appropriate,

                     —

                     shall pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment,

                     —

                     shall pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants. Conditions of authorisation shall include risk mitigation measures, where appropriate.’


title: Commission Implementing Regulation (EU) No 570/2013 of 17 June 2013 approving the active substance geraniol, 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:
               20.6.2013

               EN

               Official Journal of the European Union

               L 168/18

      COMMISSION IMPLEMENTING REGULATION (EU) No 570/2013
   of 17 June 2013
   approving the active substance geraniol, 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, 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 geraniol the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2011/266/EU (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 7 March 2008 an application from Eden Research PLC for the inclusion of the active substance geraniol in Annex I to Directive 91/414/EEC. Decision 2011/266/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 30 June 2011.

               (4)

               The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the review of the pesticide risk assessment of the active substance geraniol (4) on 15 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 the draft assessment report was finalised on 17 May 2013 in the format of the Commission review report for geraniol.

               (5)

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

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

               (9)

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

               (10)

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

               (11)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of active substance
   The active substance geraniol, 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 geraniol as an active substance by 31 May 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 geraniol 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 November 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 geraniol as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or

               (b)

               in the case of a product containing geraniol as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 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 December 2013.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 17 June 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 114, 4.5.2011, p. 3.

      (4)  EFSA Journal (2012) 10(11):2915. 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

                  Geraniol CAS No 106-24-1
                  CIPAC No 968

                  (E) 3,7-dimethyl-2,6-octadien-1-ol

                  ≥ 980 g/kg

                  1 December 2013

                  30 November 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 geraniol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to

                              —

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

                              —

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

                              —

                              the risk to aquatic organisms;

                              —

                              the risk to birds and mammals.

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

                              (a)

                              data comparing natural background exposure situations of geraniol in relation to exposure from the use of geraniol as a plant protection product. This data shall cover human exposure as well as exposure of birds, mammals and aquatic organisms;

                              (b)

                              the groundwater exposure.

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

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

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

                     Number

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘46

                     Geraniol CAS No 106-24-1
                     CIPAC No 968

                     (E) 3,7-dimethyl-2,6-octadien-1-ol

                     ≥ 980 g/kg

                     1 December 2013

                     30 November 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 geraniol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to

                                 —

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

                                 —

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

                                 —

                                 the risk to aquatic organisms;

                                 —

                                 the risk to birds and mammals.

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

                                 (a)

                                 data comparing natural background exposure situations of geraniol in relation to exposure from the use of geraniol as a plant protection product. This data shall cover human exposure as well as exposure of birds, mammals and aquatic organisms;

                                 (b)

                                 the groundwater exposure.

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

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


title: Commission Implementing Regulation (EU) No 1089/2013 of 4 November 2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance kieselgur (diatomaceous earth)  Text with EEA relevance

text:
               5.11.2013

               EN

               Official Journal of the European Union

               L 293/31

         COMMISSION IMPLEMENTING REGULATION (EU) No 1089/2013
   of 4 November 2013
   amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance kieselgur (diatomaceous earth)
   (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) and Article 78(2) thereof,
   Whereas:

               (1)

               The active substance kieselgur (diatomaceous earth) was included in Annex I to Council Directive 91/414/EEC (2) by Commission Directive 2008/127/EC (3) in accordance with the procedure provided for in Article 24b of Commission Regulation (EC) No 2229/2004 (4). Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, this substance is deemed to have been approved under that Regulation and is listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (5).

               (2)

               In accordance with Article 25a of Regulation (EC) No 2229/2004, the European Food Safety Authority, hereinafter ‘the Authority’, presented to the Commission its view on the draft review report for kieselgur (diatomaceous earth) on 22 June 2012. The Authority communicated its view on kieselgur (diatomaceous earth) to the notifier. The Commission invited it to submit comments on the draft review report for kieselgur (diatomaceous earth). The draft review report and the view of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and the draft review report was finalised on 3 October 2013 in the format of the Commission review report for kieselgur (diatomaceous earth).

               (3)

               It is confirmed that the active substance kieselgur (diatomaceous earth) is to be deemed to have been approved under Regulation (EC) No 1107/2009.

               (4)

               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. It is, in particular, appropriate to require further confirmatory information.

               (5)

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

               (6)

               Member States should be provided with time to amend or withdraw authorisations for plant protection products containing kieselgur (diatomaceous earth).

               (7)

               For plant protection products containing kieselgur (diatomaceous earth), where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, this period should expire at the latest eighteen months after the date of entry into force of the Regulation.

               (8)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Amendment to Implementing Regulation (EU) No 540/2011
   Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
   Article 2
   Transitional measures
   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing kieselgur (diatomaceous earth) as active substance by 25 May 2014.
   Article 3
   Grace period
   Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire by 25 May 2015 at the latest.
   Article 4
   Entry into force
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 4 November 2013.

            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 on the placing on the market of plant protection products (OJ L 230, 19.8.1991, p. 1).

      (3)  Commission Directive 2008/127/EC of 18 December 2008 amending Council Directive 91/414/EEC to include several active substances (OJ L 344, 20.12.2008, p. 89).

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

      (5)  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
      In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 236 on the active substance kieselgur (diatomaceous earth) is replaced by the following:

                     Number

                     Common name, Identification numbers

                     IUPAC name

                     Purity

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘236

                     Kieselgur (diatomaceous earth)
                     CAS No 61790-53-2
                     CIPAC No 647

                     Kieselgur (no IUPAC name)
                     Diatomaceous earth
                     Amorphous silicon dioxide
                     Silica
                     Diatomite

                     The product consists of 100 % diatomaceous earth.
                     Maximum 0,1 % of particles of crystalline silica with diameter below 50 μm

                     1 September 2009

                     31 August 2019

                     PART A
                     Only indoor uses as insecticide and acaricide by professional users 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 kieselgur (diatomaceous earth) (SANCO/2617/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to the safety of operators and workers. Conditions of use shall include the application of adequate personal and respiratory protective equipment. Where necessary, conditions of use shall prohibit the presence of workers after application of the product concerned for a period appropriate in view of the risks caused by that product.
                     The Member States concerned shall ensure that the notifiers submit, by 25 November 2015, to the Commission, the Member States and the Authority information concerning the inhalation toxicity to confirm the occupational limits of kieselgur (diatomaceous earth).’


title: Commission Implementing Regulation (EU) 2015/1044 of 30 June 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               1.7.2015

               EN

               Official Journal of the European Union

               L 167/67

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/1044
   of 30 June 2015
   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 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) 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, 30 June 2015.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General for Agriculture and Rural Development

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

      (2)  OJ L 157, 15.6.2011, p. 1.

      ANNEX

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

                  (EUR/100 kg)

                  CN code

                  Third country code (1)

                  Standard import value

                  0702 00 00

                  AL

                  32,3

                  MA

                  147,7

                  MK

                  63,5

                  ZZ

                  81,2

                  0707 00 05

                  TR

                  106,1

                  ZZ

                  106,1

                  0709 93 10

                  TR

                  122,9

                  ZZ

                  122,6

                  0805 50 10

                  AR

                  115,4

                  BO

                  144,3

                  TR

                  102,0

                  UY

                  130,0

                  ZA

                  136,5

                  ZZ

                  125,6

                  0808 10 80

                  AR

                  86,7

                  BR

                  101,6

                  CL

                  126,4

                  NZ

                  149,4

                  US

                  109,6

                  ZA

                  125,2

                  ZZ

                  116,5

                  0809 10 00

                  IL

                  315,1

                  TR

                  253,8

                  ZZ

                  284,5

                  0809 29 00

                  TR

                  321,9

                  US

                  581,4

                  ZZ

                  451,7

                  0809 40 05

                  IL

                  221,0

                  ZZ

                  221,0

         (1)  Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7). Code ‘ZZ’ stands for ‘of other origin’.


title: Commission Implementing Regulation (EU) No 914/2011 of 13 September 2011 amending Regulation (EU) No 605/2010 laying down animal and public health and veterinary certification conditions for the introduction into the European Union of raw milk and dairy products intended for human consumption  Text with EEA relevance

text:
               14.9.2011

               EN

               Official Journal of the European Union

               L 237/1

         COMMISSION IMPLEMENTING REGULATION (EU) No 914/2011
   of 13 September 2011
   amending Regulation (EU) No 605/2010 laying down animal and public health and veterinary certification conditions for the introduction into the European Union of raw milk and dairy products intended for human consumption
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (1), and in particular the introductory phrase and point (b) of Article 9(4) thereof,
   Whereas:

               (1)

               Regulation (EU) No 605/2010 of 2 July 2010 (2) laying down animal and public health and veterinary certification conditions for the introduction into the European Union of raw milk and dairy products intended for human consumption provides that consignments of raw milk and dairy products intended for human consumption, authorised for importation into the Union, are to be accompanied by a health certificate drawn up in accordance with the appropriate model set out in Part 2 of Annex II thereto for the commodity concerned (‘the model health certificates’).

               (2)

               It should be clarified that the requirement regarding the use of the model health certificates provided for in that Regulation is without prejudice to specific certification requirements laid down in other Union acts or in agreements concluded by the Union with third countries.

               (3)

               The model health certificates specify the commodity code for the commodities covered by Regulation (EU) No 605/2010 on the basis of the Harmonised Commodity Description and Coding System (‘HS codes’) of tariff nomenclature maintained by the World Customs Organization (WCO).

               (4)

               Certain dairy products covered by Regulation (EU) No 605/2010 do not fall within the commodity codes in the model health certificates. In order to allow a more precise identification of those commodities in the model health certificates, it is necessary to amend those models and add the missing HS codes, in particular as regards HS codes 35.01 and 35.02 (casein, caseinates and albumines).

               (5)

               In addition, it should be clarified in the model health certificates that the requirements regarding antibiotic residues, contaminants and pesticide residues may be based on the findings of official monitoring programmes which are at least equivalent to those provided for in Union legislation.

               (6)

               For reasons of clarity and transparency of Union legislation, the model health certificates should be replaced by the model health certificates set out in the Annex to this Regulation.

               (7)

               Regulation (EU) No 605/2010 should therefore be amended accordingly.

               (8)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Regulation (EU) No 605/2010 is amended as follows:

               (1)

               In Article 1, the following second paragraph is added:
               ‘This Regulation shall apply without prejudice to any specific certification requirements laid down in other Union acts or in agreements concluded by the Union with third countries.’

               (2)

               Annex II is amended in accordance with the Annex to this Regulation.

         Article 2
   For a transitional period until 30 November 2011, consignments of raw milk and dairy products for which the relevant health certificates have been issued in accordance with Regulation (EU) No 605/2010 before the entry into force of this Regulation may continue to be introduced into the Union.
   Article 3
   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, 13 September 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 18, 23.1.2003, p. 11.

      (2)  OJ L 175, 10.7.2010, p. 1.

      ANNEX
      In Annex II, parts 2 and 3 to Regulation (EU) No 605/2010 are replaced by the following:

         ‘PART 2

               Model Milk-RM

            Health Certificate for raw milk from third countries or parts thereof authorised in column A of Annex I to Regulation (EU) No 605/2010 intended for further processing in the European Union before being used for human consumption

               Model Milk-RMP

            Health Certificate for dairy products derived from raw milk for human consumption from third countries or parts thereof authorised in column A of Annex I to Regulation (EU) No 605/2010 intended for importation into the European Union

               Model Milk-HTB

            Health Certificate for dairy products derived from milk of cows, ewes, goats and buffaloes for human consumption from third countries or parts thereof authorised in column B of Annex I to Regulation (EU) No 605/2010 intended for importation into the European Union

               Model Milk-HTC

            Health Certificate for dairy products for human consumption from third countries or parts thereof authorised in column C of Annex I to Regulation (EU) No 605/2010 intended for importation into the European Union

         PART 3

               Model Milk-T/S

            Animal Health Certificate for raw milk or dairy products for human consumption, for [transit] / [storage] (1) (2) in the European Union


title: Commission Implementing Regulation (EU) No 1136/2013 of 12 November 2013 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances clothianidin, dimoxystrobin, oxamyl and pethoxamid  Text with EEA relevance

text:
               13.11.2013

               EN

               Official Journal of the European Union

               L 302/34

         COMMISSION IMPLEMENTING REGULATION (EU) No 1136/2013
   of 12 November 2013
   amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances clothianidin, dimoxystrobin, oxamyl and pethoxamid
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the first paragraph of Article 17 thereof,
   Whereas:

               (1)

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

               (2)

               The approvals of the active substances clothianidin, dimoxystrobin, oxamyl and pethoxamid will expire between 31 July and 30 September 2016. Applications have been submitted for the renewal of the approval of these active substances. As the requirements laid down in Commission Implementing Regulation (EU) No 844/2012 (3) apply to those active substances, it is necessary to allow applicants sufficient time to complete the renewal procedure in accordance with that Regulation. Consequently, the approvals of those active substances are likely to expire before a decision has been taken on their renewal. It is therefore necessary to extend their approval periods.

               (3)

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

               (4)

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

               (5)

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

               (6)

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

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

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 12 November 2013.

            For the Commission

            The President

         José Manuel BARROSO

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

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

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

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

                  (1)

                  in the sixth column, expiration of approval, of row 116, oxamyl, the date 31 July 2016 is replaced by 31 January 2018;

                  (2)

                  in the sixth column, expiration of approval, of row 121, clothianidin, the date 31 July 2016 is replaced by 31 January 2018;

                  (3)

                  in the sixth column, expiration of approval, of row 122, pethoxamid, the date 31 July 2016 is replaced by 31 January 2018;

                  (4)

                  in the sixth column, expiration of approval, of row 128, dimoxystrobin, the date 30 September 2016 is replaced by 31 January 2018.