title: Commission Implementing Regulation (EU) 2019/717 of 8 May 2019 renewing the approval of the active substance isoxaflutole 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:
                  10.5.2019

                  EN

                  Official Journal of the European Union

                  L 122/44

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/717
         of 8 May 2019
         renewing the approval of the active substance isoxaflutole 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 2003/68/EC (2) included isoxaflutole 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 isoxaflutole as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011 expires on 31 July 2019.

                     (4)

                     An application for the renewal of the approval of isoxaflutole 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 28 January 2015.

                     (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 dossier available to the public.

                     (8)

                     On 18 February 2016, the Authority communicated to the Commission its conclusion (6) on whether isoxaflutole can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented an initial draft renewal report for isoxaflutole to the Standing Committee on Plants, Animals, Food and Feed on 12 July 2016.

                     (9)

                     As regards the new criteria to identify endocrine disrupting properties introduced by Commission Regulation (EU) 2018/605 (7), which became applicable on 10 November 2018, the conclusion of the Authority infers that while no specific studies were available for non-target organisms, it is highly unlikely that isoxaflutole is an endocrine disrupter based on the scientific evidence and that no additional studies are considered necessary. Thus, the Commission considers that isoxaflutole is not to be considered as having endocrine disrupting properties.

                     (10)

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

                     (11)

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

                     (12)

                     In accordance with Article 14(1) 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.

                     (13)

                     The Commission considers that isoxaflutole does not have endocrine disrupting properties based on the available scientific information summarised in the conclusion of the Authority. However, in order to increase the confidence in this conclusion, the applicant should provide an updated assessment, in accordance with point 2.2(b) of Annex II to Regulation (EC) No 1107/2009, of the criteria laid down in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605 and in accordance with the guidance for the identification of endocrine disruptors (8).

                     (14)

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

                     (15)

                     This Regulation should apply from the day after the date of expiry of the approval of the active substance isoxaflutole.

                     (16)

                     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 isoxaflutole, as specified in Annex I, is renewed 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 and date of application
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            It shall apply from 1 August 2019.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 8 May 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Directive 2003/68/EC of 11 July 2003 amending Council Directive 91/414/EEC to include trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone and isoxaflutole as active substances (OJ L 177, 16.7.2003, p. 12).

            (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), 2016. Conclusion on the peer review of the pesticide risk assessment of the active substance isoxaflutole. EFSA Journal 2016;14(3):4416, 115 pp. doi:10.2903/j.efsa.2016.4416. Available online: www.efsa.europa.eu.

            (7)  Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33).

            (8)  Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2018.5311

            ANNEX I

                        Common Name, Identification Numbers

                        IUPAC Name

                        Purity (1)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                        Isoxaflutole
                        CAS No 141112-29-0
                        CIPAC No 575

                        (5-cyclopropyl-1,2-oxazol-4-yl)(α,α,α-trifluoro-2-mesyl-p-tolyl)methanone

                        ≥ 972 g/kg

                        1 August 2019

                        31 July 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 isoxaflutole, and in particular Appendices I and II thereto, shall be taken into account.
                        In this overall assessment, Member States shall pay particular attention to:

                                    —

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

                                    —

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

                              Conditions of use shall include risk mitigation measures, where appropriate.
                        The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water. The applicant shall submit this information within 2 years from the date of publication, by the Commission, of a guidance document on the evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
                        The applicant shall also provide an updated assessment to confirm that isoxaflutole is not an endocrine disruptor within the meaning of points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 and in accordance with the guidance for the identification of endocrine disruptors (2) by 10 May 2021.

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

               (2)  Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 https://efsa.onlinelibrarv.wilev.eom/doi/epdt710.2903/i.efsa.2018.5311

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

                        (1)

                        in Part A, entry 63 on isoxaflutole is deleted;

                        (2)

                        in Part B, the following entry is added:

                                    ‘134

                                    Isoxaflutole
                                    CAS No 141112-29-0
                                    CIPAC No 575

                                    (5-cyclopropyl-1,2-oxazol-4-yl)(α,α,α-trifluoro-2-mesyl-p-tolyl)methanone

                                    ≥ 972 g/kg

                                    1 August 2019

                                    31 July 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 isoxaflutole, and in particular Appendices I and II thereto, shall be taken into account.
                                    In this overall assessment, Member States shall pay particular attention to:

                                                —

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

                                                —

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

                                          Conditions of use shall include risk mitigation measures, where appropriate.
                                    The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water. The applicant shall submit this information within 2 years from the date of publication, by the Commission, of a guidance document on the evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
                                    The applicant shall also provide an updated assessment to confirm that isoxaflutole is not an endocrine disruptor within the meaning of points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 and in accordance with the guidance for identification of endocrine disruptors (*1) by 10 May 2021.

               (*1)  Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 https://efsa.onlinelibrarv.wilev.eom/doi/epdt710.2903/i.efsa.2018.5311’.


title: Commission Implementing Regulation (EU) 2019/778 of 16 May 2019 amending Regulation (EU) No 1305/2014 as regards Change Control Management (Text with EEA relevance.)

text:
                  27.5.2019

                  EN

                  Official Journal of the European Union

                  LI 139/356

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/778
         of 16 May 2019
         amending Regulation (EU) No 1305/2014 as regards Change Control Management
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (1), and in particular Article 5(11) thereof,
         Whereas:

                     (1)

                     Article 19 of Regulation (EU) 2016/796 of the European Parliament and of the Council (2) requires the European Union Agency for Railways (‘the Agency’) to address recommendations to the Commission on the technical specifications for interoperability (‘TSIs’) and their revision, in accordance with Article 5 of Directive (EU) 2016/797, and to ensure that TSIs are adapted to technical progress, market trends and social requirements.

                     (2)

                     Article 13 of Commission Delegated Decision (EU) 2017/1474 (3) requires the Section 7.2 of the Annex to Commission Regulation (EU) No 1305/2014 (4) (TAF TSI) to be amended for specifying the modified change control procedure for the TAF TSI.

                     (3)

                     According to Article 5 of Regulation (EU) 2016/796, a working party has been established for making a proposal for a recommendation as regards the changes of the section 7.2 of the TAF TSI.

                     (4)

                     On 20 April 2018, the Agency addressed a recommendation to the Commission on the revision of section 7.2 of the Annex to Regulation (EU) No 1305/2014.

                     (5)

                     Section 7.2 of of the Annex to Regulation (EU) No 1305/2014 related to TAF TSI should be amended accordingly.

                     (6)

                     The list of the relevant technical documents referenced in TAF TSI should be updated.

                     (7)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee established in accordance with Article 51(1) of Directive (EU) 2016/797,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Section 7.2 of the Annex to Regulation (EU) No 1305/2014 is replaced by Annex I to this Regulation.

            Article 2
            Appendix I of the Annex to Regulation (EU) No 1305/2014 is replaced by the text in Annex II to this Regulation.

            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, 16 May 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 138, 26.5.2016, p. 44.

            (2)  Regulation (EU) 2016/796 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Railways and repealing Regulation (EC) No 881/2004 (OJ L 138, 26.5.2016, p. 1).

            (3)  Commission Delegated Decision (EU) 2017/1474 supplementing Directive (EU) 2016/797 of the European Parliament and of the Council with regard to specific objectives for the drafting, adoption and review of technical specifications for interoperability (OJ L 210, 15.8.2017, p. 5).

            (4)  Commission Regulation (EU) No 1305/2014 of 11 December 2014 on the technical specification for interoperability relating to the telematics applications for freight subsystem of the rail system in the European Union and repealing the Regulation (EC) No 62/2006 (OJ L 356, 12.12.2014, p. 438).

            ANNEX I
            Section 7.2 of the Annex to Regulation (EU) No 1305/2014 is replaced by the following:

               ‘7.2.   Change Management

               7.2.1.   Change Management Process

               Change management procedures shall be designed to ensure that the costs and benefits of change are properly analysed and that changes are implemented in a controlled way. These procedures shall be defined, put in place, supported and managed by the Agency and shall include:

                           —

                           the identification of the technical constraints underpinning the change,

                           —

                           a statement of who takes responsibility for the change implementation procedures,

                           —

                           the procedure for validating the changes to be implemented,

                           —

                           the policy for change management, release, migration and roll-out,

                           —

                           the definition of the responsibilities for the management of the detailed specifications and for both its quality assurance and configuration management.

                     The Change Control Board (CCB) shall be composed of the Agency, rail sector representative bodies and Member States. Such an affiliation of the parties shall ensure a perspective on the changes that are to be made and an overall assessment of their implications. The CCB ultimately shall be brought under the aegis of the Agency.
               7.2.2.   Specific Change Management Process for documents listed in Appendix I to this Regulation

               The change control management for the documents listed in Appendix I to this Regulation shall be established by the Agency in accordance with the following criteria:

                           1.

                           The change requests affecting the documents are submitted either via the Member States or via the representative bodies from the railway sector acting on a European level as defined in Article 38(4) of Regulation (EU) 2016/796 of the European Parliament and of the Council (*1), or via the TAF TSI Steering Committee.

                           2.

                           The Agency shall gather and store the change requests.

                           3.

                           The Agency shall present the change requests to the dedicated ERA working party, which will evaluate them and prepare a proposal accompanied by an economic evaluation, where appropriate.

                           4.

                           Afterwards the Agency shall present each change request and the associated proposal to the change control board that will or will not validate or postpone the change request.

                           5.

                           If the change request is not validated, the Agency shall send back to the requester either the reason for the rejection or a request for additional information about the draft change request.

                           6.

                           If the change request is validated, the technical document shall be amended.

                           7.

                           If no consensus about the validation of a change request can be reached, the Agency shall submit to the Commission a recommendation to update the documents listed in Appendix I together with the draft new version of the document, the change requests and their economic evaluation and shall make these documents available on their web site.

                           8.

                           The new version of the technical document with the validated change requests shall be made available at the site of the Agency. The Agency will keep the Member States informed via the Committee established in accordance with Article 29(1) of Directive 2008/57/EC.

                           9.

                           If a change request would require a change of the legal text of the TAF TSI, the Agency shall send a request to the European commission to request a revision of the TAF TSI and/or request the technical opinion from the Agency.

                     Where change control management affects elements which are in common use within the TAP TSI, the changes shall be made so as to remain compliant to the implemented TAP TSI in order to achieve optimum synergies.

               (*1)  Regulation (EU) 2016/796 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Railways and repealing Regulation (EC) No 881/2004 (OJ L 138, 26.5.2016, p. 1).’’

            ANNEX II
            Appendix I of the Annex to Regulation (EU) No 1305/2014 is replaced by the following:

                     ‘Appendix I

                        List of technical documents

                                 No

                                 Reference

                                 Title

                                 1

                                 ERA-TD-100

                                 TAF TSI — ANNEX A.5:FIGURES AND SEQUENCE DIAGRAMS OF THE TAF TSI MESSAGES

                                 2

                                 ERA-TD-101

                                 Annex D.2: Appendix A (Wagon/ILU Trip Planning)

                                 3

                                 ERA-TD-102

                                 Annex D.2: Appendix B — Wagon and Intermodal Unit Operating
                                 Database (WIMO)

                                 4

                                 ERA-TD-103

                                 Annex D.2: Appendix C — Reference Files

                                 5

                                 ERA-TD-104

                                 Annex D.2: Appendix E — Common Interface

                                 6

                                 ERA-TD-105

                                 Annex D.2: Appendix F — TAF TSI Data and Message Model

               ’