title: Council Implementing Regulation (EU) 2018/1912 of 4 December 2018 amending Implementing Regulation (EU) No 282/2011 as regards certain exemptions for intra-Community transactions

text:
                  7.12.2018

                  EN

                  Official Journal of the European Union

                  L 311/10

         COUNCIL IMPLEMENTING REGULATION (EU) 2018/1912
         of 4 December 2018
         amending Implementing Regulation (EU) No 282/2011 as regards certain exemptions for intra-Community transactions
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax (1), and in particular Article 397 thereof,
         Having regard to the proposal from the European Commission,
         Whereas:

                     (1)

                     In its communication of 7 April 2016 on an action plan on VAT, the Commission announced its intention to put forward a proposal for a definitive value added tax (VAT) system in relation to cross-border business-to-business trade between Member States. The Council, in its conclusions of 8 November 2016, invited the Commission to propose in the meantime certain improvements to the Union VAT rules for cross-border transactions, inter alia, for the purposes of exemptions in respect of intra-Community transactions.

                     (2)

                     Directive 2006/112/EC sets out a number of conditions for the exemption of supplies of goods from VAT in the context of certain intra-Community transactions. One of those conditions is that the goods have to be dispatched or transported from one Member State to another.

                     (3)

                     However, the divergent approach amongst Member States in the application of those exemptions for cross-border transactions has created difficulties and legal uncertainty for businesses. This is contrary to the objective of enhancing intra-Community trade and to the abolition of the fiscal borders. It is therefore important to specify and harmonise the conditions under which the exemptions can apply.

                     (4)

                     As cross-border VAT fraud is primarily linked to the exemption for intra-Community supplies, it is necessary to specify certain circumstances in which goods should be considered as having been dispatched or transported from the territory of the Member State of supply.

                     (5)

                     In order to provide a practical solution for businesses and also to provide assurance for tax administrations, two rebuttable presumptions should be introduced in Council Implementing Regulation (EU) No 282/2011 (2).

                     (6)

                     The call-off stock simplification arrangements should be accompanied by appropriate recording obligations in order to ensure their correct application.

                     (7)

                     Implementing Regulation (EU) No 282/2011 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Implementing Regulation (EU) No 282/2011 is amended as follows:

                        (1)

                        in Chapter VIII, the following Section is inserted:
                        ‘Section 2A

                              Exemptions for intra-Community transactions

                              (Articles 138 to 142 of Directive 2006/112/EC)

                           Article 45a

                              1.   For the purpose of applying the exemptions laid down in Article 138 of Directive 2006/112/EC, it shall be presumed that goods have been dispatched or transported from a Member State to a destination outside its territory but within the Community in either of the following cases:

                                          (a)

                                          the vendor indicates that the goods have been dispatched or transported by him or by a third party on his behalf, and either the vendor is in possession of at least two items of non-contradictory evidence referred to in point (a) of paragraph 3 which were issued by two different parties that are independent of each other, of the vendor and of the acquirer, or the vendor is in possession of any single item referred to in point (a) of paragraph 3 together with any single item of non-contradictory evidence referred to in point (b) of paragraph 3 confirming the dispatch or transport which were issued by two different parties that are independent of each other, of the vendor and of the acquirer;

                                          (b)

                                          the vendor is in possession of the following:

                                                      (i)

                                                      a written statement from the acquirer, stating that the goods have been dispatched or transported by the acquirer, or by a third party on behalf of the acquirer, and identifying the Member State of destination of the goods; that written statement shall state: the date of issue; the name and address of the acquirer; the quantity and nature of the goods; the date and place of the arrival of the goods; in the case of the supply of means of transport, the identification number of the means of transport; and the identification of the individual accepting the goods on behalf of the acquirer; and

                                                      (ii)

                                                      at least two items of non-contradictory evidence referred to in point (a) of paragraph 3 that were issued by two different parties that are independent of each other, of the vendor and of the acquirer, or any single item referred to in point (a) of paragraph 3 together with any single item of non-contradictory evidence referred to in point (b) of paragraph 3 confirming the dispatch or transport which were issued by two different parties that are independent of each other, of the vendor and of the acquirer.

                                    The acquirer shall furnish the vendor with the written statement referred to in point (b)(i) by the tenth day of the month following the supply.

                              2.   A tax authority may rebut a presumption that has been made under paragraph 1.

                              3.   For the purposes of paragraph 1, the following shall be accepted as evidence of dispatch or transport:

                                          (a)

                                          documents relating to the dispatch or transport of the goods, such as a signed CMR document or note, a bill of lading, an airfreight invoice or an invoice from the carrier of the goods;

                                          (b)

                                          the following documents:

                                                      (i)

                                                      an insurance policy with regard to the dispatch or transport of the goods, or bank documents proving payment for the dispatch or transport of the goods;

                                                      (ii)

                                                      official documents issued by a public authority, such as a notary, confirming the arrival of the goods in the Member State of destination;

                                                      (iii)

                                                      a receipt issued by a warehouse keeper in the Member State of destination, confirming the storage of the goods in that Member State.’;

                        (2)

                        in Chapter X, the following Section is inserted:
                        ‘Section 1A

                              General obligations

                              (Articles 242 to 243 of Directive 2006/112/EC)

                           Article 54a

                              1.   The register referred to in Article 243(3) of Directive 2006/112/EC that is to be kept by every taxable person who transfers goods under call-off stock arrangements shall contain the following information:

                                          (a)

                                          the Member State from which the goods were dispatched or transported, and the date of dispatch or transport of the goods;

                                          (b)

                                          the VAT identification number of the taxable person for whom the goods are intended, issued by the Member State to which the goods are dispatched or transported;

                                          (c)

                                          the Member State to which the goods are dispatched or transported, the VAT identification number of the warehouse keeper, the address of the warehouse at which the goods are stored upon arrival, and the date of arrival of the goods in the warehouse;

                                          (d)

                                          the value, description and quantity of the goods that arrived in the warehouse;

                                          (e)

                                          the VAT identification number of the taxable person substituting for the person referred to in point (b) of this paragraph under the conditions referred to in Article 17a(6) of Directive 2006/112/EC;

                                          (f)

                                          the taxable amount, description and quantity of the goods supplied and the date on which the supply of the goods referred to in point (a) of Article 17a(3) of Directive 2006/112/EC is made and the VAT identification number of the buyer;

                                          (g)

                                          the taxable amount, description and quantity of the goods, and the date of occurrence of any of the conditions and the respective ground in accordance with Article 17a(7) of Directive 2006/112/EC;

                                          (h)

                                          the value, description and quantity of the returned goods and the date of the return of the goods referred to in Article 17a(5) of Directive 2006/112/EC.

                              2.   The register referred to in Article 243(3) of Directive 2006/112/EC that is to be kept by every taxable person to whom goods are supplied under call-off stock arrangements shall contain the following information:

                                          (a)

                                          the VAT identification number of the taxable person who transfers goods under call-off stock arrangements;

                                          (b)

                                          the description and quantity of the goods intended for him;

                                          (c)

                                          the date on which the goods intended for him arrive in the warehouse;

                                          (d)

                                          the taxable amount, description and quantity of the goods supplied to him and the date on which the intra-Community acquisition of the goods referred to in point (b) of Article 17a(3) of Directive 2006/112/EC is made;

                                          (e)

                                          the description and quantity of the goods, and the date on which the goods are removed from the warehouse by order of the taxable person referred to in point (a);

                                          (f)

                                          the description and quantity of the goods destroyed or missing and the date of destruction, loss or theft of the goods that previously arrived in the warehouse or the date on which the goods were found to be destroyed or missing.

                                    Where the goods are dispatched or transported under call-off stock arrangements to a warehouse keeper different from the taxable person for whom the goods are intended to be supplied, the register of that taxable person does not need to contain the information referred to in points (c), (e) and (f) of the first subparagraph.’.

            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 January 2020.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 4 December 2018.

                  For the Council

                  The President

               H. LÖGER

            (1)  OJ L 347, 11.12.2006, p. 1.

            (2)  Council Implementing Regulation (EU) No 282/2011 of 15 March 2011 laying down implementing measures for Directive 2006/112/EC on the common system of value added tax (OJ L 77, 23.3.2011, p. 1).


title: Commission Implementing Regulation (EU) 2018/1915 of 6 December 2018 approving the active substance Metschnikowia fructicola strain NRRL Y-27328 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:
                  7.12.2018

                  EN

                  Official Journal of the European Union

                  L 311/20

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1915
         of 6 December 2018
         approving the active substance Metschnikowia fructicola strain NRRL Y-27328 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 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)

                     In accordance with Article 7(1) of Regulation (EC) No 1107/2009 Koppert B.V. submitted to France on 30 September 2014 an application for the approval of the active substance Metschnikowia fructicola strain NRRL Y-27328.

                     (2)

                     In accordance with Article 9(3) of that Regulation, France, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) on 3 June 2015 of the admissibility of the application.

                     (3)

                     On 17 October 2016, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

                     (4)

                     The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of that Regulation, it requested on 20 March 2017 that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report on 12 September 2017.

                     (5)

                     On 24 November 2017 the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance Metschnikowia fructicola strain NRRL Y-27328 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public.

                     (6)

                     On 20 July 2018, the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for Metschnikowia fructicola strain NRRL Y-27328 and a draft Regulation providing that Metschnikowia fructicola strain NRRL Y-27328 is approved.

                     (7)

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

                     (8)

                     It is therefore appropriate to approve Metschnikowia fructicola strain NRRL Y-27328.

                     (9)

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

                     (10)

                     In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly.

                     (11)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Approval of active substance
            The active substance Metschnikowia fructicola strain NRRL Y-27328, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

            Article 2
            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 3
            Entry into force
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 6 December 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the pesticide risk assessment of the active substance Metschnikowia fructicola NRRL Y-27328 EFSA Journal 2017;15(12):5084, 19 pp. doi:10.2903/j.efsa.2017.5084.

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

            ANNEX I

                        Common Name, Identification Numbers

                        IUPAC Name

                        Purity (1)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                           Metschnikowia fructicola strain NRRL Y-27328
                        Accession number in the Agriculture Research Service Culture Collection at the National center for agricultural utilisation research in Peoria, Illinois USA

                        Not applicable

                        Minimum concentration:
                        1 × 1010 CFU/g

                        27 December 2018

                        27 December 2028

                        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 Metschnikowia fructicola strain NRRL Y-27328, and in particular Appendices I and II thereof, shall be taken into account.
                        In this overall assessment Member States shall pay particular attention to:

                                    —

                                    the protection of operators and workers, taking into account that Metschnikowia fructicola strain NRRL Y-27328 is to be considered as a potential sensitizer.

                              Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be ensured by the producer.
                        Conditions of use shall include risk mitigation measures, where appropriate.

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

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

                           No

                           Common Name, Identification Numbers

                           IUPAC Name

                           Purity (1)

                           Date of approval

                           Expiration of approval

                           Specific provisions

                           ‘129

                              Metschnikowia fructicola strain NRRL Y-27328
                           Accession number in the Agriculture Research Service Culture Collection at the National center for agricultural utilisation research in Peoria, Illinois USA

                           Not applicable

                           Minimum concentration:
                           1 × 1010 CFU/g

                           27 December 2018

                           27 December 2028

                           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 Metschnikowia fructicola strain NRRL Y-27328, and in particular Appendices I and II thereof, shall be taken into account.
                           In this overall assessment Member States shall pay particular attention to:

                                       —

                                       the protection of operators and workers, taking into account that Metschnikowia fructicola strain NRRL Y-27328 is to be considered as a potential sensitizer.

                                 Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be ensured by the producer.
                           Conditions of use shall include risk mitigation measures, where appropriate.’

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


title: Commission Implementing Regulation (EU) 2018/1913 of 6 December 2018 renewing the approval of the active substance tribenuron 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:
                  7.12.2018

                  EN

                  Official Journal of the European Union

                  L 311/13

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1913
         of 6 December 2018
         renewing the approval of the active substance tribenuron 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 20(1) thereof,
         Whereas:

                     (1)

                     Commission Directive 2005/54/EC (2) included tribenuron as an active substance in Annex I to Council Directive 91/414/EEC (3).

                     (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 approval of the active substance tribenuron, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 October 2019.

                     (4)

                     An application for the renewal of the approval of tribenuron was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

                     (5)

                     The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

                     (6)

                     The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 23 June 2016.

                     (7)

                     The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossiers available to the public.

                     (8)

                     On 29 June 2017 the Authority communicated to the Commission its conclusion (6) on whether tribenuron can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft renewal report for tribenuron to the Standing Committee on Plants, Animals, Food and Feed on 12 December 2017.

                     (9)

                     The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with the third paragraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, on the draft renewal report. The applicant submitted its comments, which have been carefully examined.

                     (10)

                     It has been established with respect to one or more representative uses of at least one plant protection product containing tribenuron that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to renew the approval of tribenuron.

                     (11)

                     The risk assessment for the renewal of the approval of tribenuron is based on a limited number of representative uses, which, however, do not restrict the uses for which plant protection products containing tribenuron may be authorised. It is therefore appropriate to remove the restriction for use only as a herbicide.

                     (12)

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

                     (13)

                     Commission Implementing Regulation (EU) 2018/1262 (7) extended the expiry date of tribenuron to 31 October 2019 in order to allow the renewal process to be completed before the expiry of the approval of that substance. Given that a decision on renewal has been taken ahead of this extended expiry date, this Regulation shall apply from 1 February 2019.

                     (14)

                     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
            Renewal of the approval of active substance
            The approval of the active substance tribenuron is renewed as set out in Annex I.

            Article 2
            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 3
            Entry into force and date of application
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            It shall apply from 1 February 2019.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 6 December 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Directive 2005/54/EC of 19 September 2005 amending Council Directive 91/414/EEC to include tribenuron as active substance (OJ L 244, 20.9.2005, p. 21).

            (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).

            (5)  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).

            (6)  EFSA (European Food Safety Authority), 2017. Conclusion on the peer review of the pesticide risk assessment of the active substance tribenuron. EFSA Journal 2017;15(7):4912 [39 pp]. doi: 10.2903/j.efsa.2017.4912.

            (7)  Commission Implementing Regulation (EU) 2018/1262 of 20 September 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-methylcyclopropene, beta-cyfluthrin, chlorothalonil, chlorotoluron, clomazone, cypermethrin, daminozide, deltamethrin, dimethenamid-p, diuron, fludioxonil, flufenacet, flurtamone, fosthiazate, indoxacarb, MCPA, MCPB, prosulfocarb, thiophanate-methyl and tribenuron (OJ L 238, 21.9.2018, p. 62).

            ANNEX I

                        Common Name, Identification Numbers

                        IUPAC Name

                        Purity (1)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                        Tribenuron (parent)
                        CAS No 106040-48-6
                        CIPAC No 546

                        2-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-methylcarbamoyl]sulfamoyl]benzoic acid

                        ≥ 960 g/kg (expressed as tribenuron-methyl)

                        1 February 2019

                        30 January 2034

                        For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on tribenuron, and in particular Appendices I and II thereof, shall be taken into account.
                        In this overall assessment Member States shall pay particular attention to:

                                    —

                                    the protection of consumers, in particular to residues on animal products,

                                    —

                                    the protection of groundwater,

                                    —

                                    the protection of aquatic organisms and of non-target terrestrial plants.

                              Conditions of use shall include risk mitigation measures, where appropriate.

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

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

                        (1)

                        in Part A, entry 106 on tribenuron is deleted;

                        (2)

                        in Part B, the following entry is added:

                                    Number

                                    Common Name, Identification Numbers

                                    IUPAC Name

                                    Purity (1)

                                    Date of approval

                                    Expiration of approval

                                    Specific provisions

                                    ‘128

                                    Tribenuron (parent)
                                    CAS No 106040-48-6
                                    CIPAC No 546

                                    2-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-methylcarbamoyl]sulfamoyl]benzoic acid

                                    ≥ 960 g/kg (expressed as tribenuron-methyl)

                                    1 February 2019

                                    30 January 2034

                                    For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on tribenuron, and in particular Appendices I and II thereof, shall be taken into account.
                                    In this overall assessment Member States shall pay particular attention to:

                                                —

                                                the protection of consumers, in particular to residues on animal products,

                                                —

                                                the protection of groundwater,

                                                —

                                                the protection of aquatic organisms and of non-target terrestrial plants.

                                          Conditions of use shall include risk mitigation measures, where appropriate.’

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


title: Commission Implementing Regulation (EU) 2018/1914 of 6 December 2018 concerning the non-renewal of approval of the active substance quinoxyfen, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance.)

text:
                  7.12.2018

                  EN

                  Official Journal of the European Union

                  L 311/17

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1914
         of 6 December 2018
         concerning the non-renewal of approval of the active substance quinoxyfen, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) and Article 78(2) thereof,
         Whereas:

                     (1)

                     Commission Directive 2004/60/EC (2) included quinoxyfen as an active substance in Annex I to Council Directive 91/414/EEC (3).

                     (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 approval of the active substance quinoxyfen, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 April 2019.

                     (4)

                     An application for the renewal of the approval of quinoxyfen was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

                     (5)

                     The applicant submitted the supplementary dossiers required in accordance with Article 6 of Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

                     (6)

                     The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 5 December 2016.

                     (7)

                     In accordance with Article 11(4) of Implementing Regulation (EU) No 844/2012, that assessment was limited to a targeted assessment. The assessment did not go beyond the identity, methods of analysis, environmental fate and behavior and ecotoxicology information that related to the potential persistent bioaccumulative and toxic (PBT) properties, very persistent and very bioaccumulative (vPvB) properties and persistent organic pollutant (POP) properties of quinoxyfen, since the approval criteria set out in point 3.7.2 and 3.7.3 of Annex II to Regulation (EC) No 1107/2009 are not satisfied.

                     (8)

                     The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

                     (9)

                     On 24 November 2017 the Authority communicated to the Commission its conclusion (6) on whether quinoxyfen can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The conclusion is limited to a hazard targeted assessment (focussed on the elements referred to in point 3.7 of Annex II to Regulation (EC) No 1107/2009) and does not cover all the approval criteria. The Authority concluded that quinoxyfen is a PBT substance as well as a vPvB substance.

                     (10)

                     The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined.

                     (11)

                     However, despite the arguments put forward by the applicant, the concerns related to the substance could not be eliminated.

                     (12)

                     Based on the concerns identified, it has not been established with respect to one or more representative uses of at least one plant protection product containing quinoxyfen that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of quinoxyfen in accordance with Article 20(1)(b) of that Regulation.

                     (13)

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

                     (14)

                     For plant protection products containing quinoxyfen, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 27 March 2020.

                     (15)

                     Commission Implementing Regulation (EU) 2018/524 (7) extended the expiry date of quinoxyfen to 30 April 2019 in order to allow the renewal process to be completed before the expiry of the approval of that substance. Given that a decision has been taken ahead of this extended expiry date, this Regulation should apply as soon as possible.

                     (16)

                     This Regulation does not prevent the submission of a further application for the approval of quinoxyfen pursuant to Article 7 of Regulation (EC) No 1107/2009.

                     (17)

                     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
            Non-renewal of approval of active substance
            The approval of the active substance quinoxyfen is not renewed.

            Article 2
            Amendments to Implementing Regulation (EU) No 540/2011
            In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 82, on quinoxyfen, is deleted.

            Article 3
            Transitional measures
            Member States shall withdraw authorisations for plant protection products containing quinoxyfen as active substance by 27 June 2019 at the latest.

            Article 4
            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 27 March 2020 at the latest.

            Article 5
            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, 6 December 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Directive 2004/60/EC of 23 April 2004 amending Council Directive 91/414/EEC to include quinoxyfen as active substance (OJ L 120, 24.4.2004, p. 39).

            (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).

            (5)  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).

            (6)  EFSA (European Food Safety Authority), 2018. Peer review of the targeted hazard assessment of the pesticide active substance quinoxyfen. EFSA Journal 2018;16(1):5085 [11 pp.]. DOI: 10.2903/j.efsa.2018.5085.

            (7)  Commission Implementing Regulation (EU) 2018/524 of 28 March 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713, clodinafop, clopyralid, cyprodinil, dichlorprop-P, fosetyl, mepanipyrim, metconazole, metrafenone, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, quinoxyfen, rimsulfuron, spinosad, thiacloprid, thiamethoxam, thiram, tolclofos-methyl, triclopyr, trinexapac, triticonazole and ziram (OJ L 88, 4.4.2018, p. 4).


title: Commission Implementing Regulation (EU) 2018/1956 of 6 December 2018 approving an amendment to the specification for a Protected Designation of Origin or a Protected Geographical Indication (‘Μαντινεία’ (Mantinia) (PDO))

text:
                  12.12.2018

                  EN

                  Official Journal of the European Union

                  L 315/22

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1956
         of 6 December 2018
         approving an amendment to the specification for a Protected Designation of Origin or a Protected Geographical Indication (‘Μαντινεία’ (Mantinia) (PDO))
         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), and in particular Article 99 thereof,
         Whereas:

                     (1)

                     The Commission has examined the application for the approval of an amendment to the specification for the Protected Designation of Origin ‘Μαντινεία’ (Mantinia), sent by Greece in accordance with Article 105 of Regulation (EU) No 1308/2013.

                     (2)

                     The Commission has published the application for the approval of an amendment to the specification in the Official Journal of the European Union, as required by Article 97(3) of Regulation (EU) No 1308/2013 (2).

                     (3)

                     No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

                     (4)

                     The amendment to the specification should therefore be approved in accordance with Article 99 of Regulation (EU) No 1308/2013.

                     (5)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The amendment to the specification published in the Official Journal of the European Union regarding the name ‘Μαντινεία’ (Mantinia) (PDO) is hereby approved.

            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, 6 December 2018.

                  For the Commission,

                  On behalf of the President,

               Phil HOGAN

                  Member of the Commission

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

            (2)  OJ C 302, 28.8.2018, p. 13.