title: Commission Implementing Regulation (EU) 2019/148 of 30 January 2019 concerning the non-approval of the active substance propanil, 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 (Text with EEA relevance.)

text:
                  31.1.2019

                  EN

                  Official Journal of the European Union

                  L 27/18

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/148
         of 30 January 2019
         concerning the non-approval of the active substance propanil, 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
         (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)

                     In accordance with Article 7(1) of Regulation (EC) No 1107/2009, on 28 December 2015, Italy received an application from UPL Europe Ltd for the approval of the active substance propanil.

                     (2)

                     In accordance with Article 9(3) of that Regulation, the rapporteur Member State notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) of the admissibility of the application, on 29 February 2016.

                     (3)

                     For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with Regulation (EC) No 1107/2009, for the uses proposed by the applicant. The rapporteur Member State submitted a draft assessment report to the Commission and the Authority on 14 July 2017.

                     (4)

                     The draft assessment report was reviewed by the Member States and the Authority. The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance propanil (2) on 6 September 2018.

                     (5)

                     By letter of 14 September 2018 UPL Europe Ltd withdrew its application for the approval of propanil.

                     (6)

                     Due to the withdrawal of the application, propanil should not be approved.

                     (7)

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

                     (8)

                     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-approval of active substance
            The active substance propanil is not approved.

            Article 2
            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, 30 January 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  EFSA Journal 2018;16(12):5418, 27 pp. https://doi.org/10.2903/j.efsa.2018.5418, Conclusion on the peer review of the pesticide risk assessment of the active substance propanil.


title: Commission Implementing Regulation (EU) 2019/149 of 30 January 2019 amending Implementing Regulations (EU) 2015/1108 and (EU) No 540/2011 as regards the conditions of use of vinegar as a basic substance (Text with EEA relevance.)

text:
                  31.1.2019

                  EN

                  Official Journal of the European Union

                  L 27/20

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/149
         of 30 January 2019
         amending Implementing Regulations (EU) 2015/1108 and (EU) No 540/2011 as regards the conditions of use of vinegar as a basic substance
         (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 23(5) in conjunction with Article 13(2) thereof,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) 2015/1108 (2) approved vinegar as a basic substance for uses as fungicide and bactericide and included it in Part C of the Annex to Commission Implementing Regulation (EU) No 540/2011 (3).

                     (2)

                     In November 2016, Charbonneaux-Brabant SA submitted to the Commission an application for the extension of the use of vinegar as herbicide in accordance with Article 23(3) of Regulation (EC) No 1107/2009.

                     (3)

                     The Commission asked the European Food Safety Authority (‘the Authority’) for scientific assistance. On 4 August 2017, the Authority presented to the Commission a technical report on the extension of the use of vinegar in plant protection as herbicide (4). The Commission presented the review report to the Standing Committee on Plants, Animals, Food and Feed on 23 October 2018 and the draft of this Regulation on 12 December 2018.

                     (4)

                     It has appeared from the examinations made that vinegar may be expected to satisfy, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the use as herbicide which was examined and detailed in the review report. Therefore the use of vinegar as herbicide should be allowed. Moreover, given the fact that a new use of vinegar is being permitted, it is acceptable to allow other possible uses of vinegar as referred to in the latest version of the review report for vinegar. It is therefore appropriate to revoke the current restriction for use only as a fungicide and a bactericide.

                     (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, however, necessary to respect certain conditions for use.

                     (6)

                     Implementing Regulations (EU) 2015/1108 and (EU) No 540/2011 should therefore be amended accordingly.

                     (7)

                     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 (EU) 2015/1108
            Annex I to Implementing Regulation (EU) 2015/1108 is amended as set out in Annex I to this Regulation.

            Article 2
            Amendment to Implementing Regulation (EU) No 540/2011
            The Annex to Implementing Regulation (EU) No 540/2011 is amended as set out in 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, 30 January 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Implementing Regulation (EU) 2015/1108 of 8 July 2015 approving the basic substance vinegar 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 (OJ L 181, 9.7.2015, p. 75).

            (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).

            (4)  EFSA (European Food Safety Authority), 2017. Technical report on the outcome of the consultation with Member States and EFSA on the basic substance application for vinegar for extension of use in plant protection as a herbicide. EFSA supporting publication 2017: EN — 1281. 42 pp. doi:10.2903/sp.efsa.2017.EN — 1281.

            ANNEX I
            In Annex I to Implementing Regulation (EU) 2015/1108, the entry in the fifth column ‘Specific provisions’ is replaced by the following:

               ‘Vinegar shall be used in accordance with the specific conditions included in the conclusions of the review report on vinegar (SANCO/12896/2014) and in particular Appendices I and II thereof.’

            ANNEX II
            In the Annex to Implementing Regulation (EU) No 540/2011, the entry in the sixth column ‘Specific provisions’ of row number 5, vinegar, of the table in Part C is replaced by the following:

               ‘Vinegar shall be used in accordance with the specific conditions included in the conclusions of the review report on vinegar (SANCO/12896/2014) and in particular Appendices I and II thereof.’


title: Commission Implementing Regulation (EU) 2019/150 of 30 January 2019 amending Implementing Regulation (EU) No 686/2012 as regards the rapporteur Member State for the evaluation of the following active substances contained in plant protection products: deltamethrin, diflufenican, epoxiconazole, fluoxastrobin, prothioconazole and tebuconazole (Text with EEA relevance.)

text:
                  31.1.2019

                  EN

                  Official Journal of the European Union

                  L 27/23

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/150
         of 30 January 2019
         amending Implementing Regulation (EU) No 686/2012 as regards the rapporteur Member State for the evaluation of the following active substances contained in plant protection products: deltamethrin, diflufenican, epoxiconazole, fluoxastrobin, prothioconazole and tebuconazole
         (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 19, thereof,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) No 686/2012 (2) allocated to the United Kingdom, as rapporteur Member State, the evaluation of certain active substances contained in plant protection products.

                     (2)

                     On 29 March 2017, the United Kingdom submitted the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union. The Treaties will cease to apply to the United Kingdom from the date of entry into force of a withdrawal agreement or failing that, two years after that notification, i.e. from 30 March 2019, unless the European Council, in agreement with the United Kingdom, unanimously decides to extend that period.

                     (3)

                     The withdrawal agreement as agreed between the negotiators contains arrangements for the application of provisions of Union law to and in the United Kingdom beyond the date the Treaties cease to apply to and in the United Kingdom. If that agreement enters into force Union legislation in the field of plant protection products will apply to and in the United Kingdom during the transition period in accordance with that agreement and will cease to apply at the end of that period. In accordance with that agreement, during the transition period the United Kingdom is not to act as leading authority for risk assessments, examinations, approvals or authorisations at the level of the Union or at the level of Member States acting jointly as referred to, amongst others, in Regulation (EC) No 1107/2009.

                     (4)

                     It is therefore necessary to allocate to other Member States the evaluation of the active substances for which the United Kingdom is the rapporteur Member State and where it is expected that the European Food Safety Authority will not issue a Conclusion before 29 March 2019. The active substances concerned are deltamethrin, diflufenican, epoxiconazole, fluoxastrobin, prothioconazole and tebuconazole.

                     (5)

                     That allocation should ensure a balance in the distribution of the responsibilities and the work between Member States.

                     (6)

                     As the evaluation of the active substances concerned are at an advanced stage and the work to be carried out is expected to be minor, a co-rapporteur Member State should not be allocated for that evaluation.

                     (7)

                     Implementing Regulation (EU) No 686/2012 should therefore be amended accordingly.

                     (8)

                     This Regulation should apply from 30 March 2019.

                     (9)

                     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
            Implementing Regulation (EU) No 686/2012 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 30 March 2019.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 30 January 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Implementing Regulation (EU) No 686/2012 of 26 July 2012 allocating to Member States, for the purposes of the renewal procedure, the evaluation of the active substances whose approval expires by 31 December 2018 at the latest (OJ L 200, 27.7.2012, p. 5).

            ANNEX
            The Annex to Implementing Regulation (EU) No 686/2012 is amended as follows:

                        (1)

                        Part A is amended as follows:

                                    (a)

                                    the entry for Deltamethrin is replaced by the following:

                                                Active substance

                                                Rapporteur Member State

                                                Co-rapporteur Member State

                                                ‘Deltamethrin

                                                AT’

                                    (b)

                                    the entry for Diflufenican is replaced by the following:

                                                Active substance

                                                Rapporteur Member State

                                                Co-rapporteur Member State

                                                ‘Diflufenican

                                                CZ’

                                    (c)

                                    the entry for Fluoxastrobin is replaced by the following:

                                                Active substance

                                                Rapporteur Member State

                                                Co-rapporteur Member State

                                                ‘Fluoxastrobin

                                                DE’

                                    (d)

                                    the entry for Prothioconazole is replaced by the following:

                                                Active substance

                                                Rapporteur Member State

                                                Co-rapporteur Member State

                                                ‘Prothioconazole

                                                PL’

                        (2)

                        Part B is amended as follows:

                                    (a)

                                    the entry for Epoxiconazole is replaced by the following:

                                                Active substance

                                                Rapporteur Member State

                                                Co-rapporteur Member State

                                                ‘Epoxiconazole

                                                PL’

                                    (b)

                                    the entry for Tebuconazole is replaced by the following:

                                                Active substance

                                                Rapporteur Member State

                                                Co-rapporteur Member State

                                                ‘Tebuconazole

                                                DK’


title: Commission Implementing Regulation (EU) 2019/151 of 30 January 2019 renewing the approval of the active substance Clonostachys rosea strain J1446 as a low-risk active substance 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:
                  31.1.2019

                  EN

                  Official Journal of the European Union

                  L 27/26

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/151
         of 30 January 2019
         renewing the approval of the active substance Clonostachys rosea strain J1446 as a low-risk active substance 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 22(1) in conjunction with Article 20(1) thereof,
         Whereas:

                     (1)

                     Commission Directive 2005/2/EC (2) included Clonostachys rosea strain J1446, under the old taxonomic name Gliocladium catenulatum strain J1446, 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 Clonostachys rosea strain J1446, 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 Clonostachys rosea strain J1446 was submitted by Verdera Oy (‘the applicant’) 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 6 July 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 dossier available to the public.

                     (8)

                     On 21 June 2017 the Authority communicated to the Commission its conclusion (6) on whether Clonostachys rosea strain J1446 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 Clonostachys rosea strain J1446 to the Standing Committee on Plants, Animals, Food and Feed on 11 December 2017.

                     (9)

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

                     (10)

                     It has been established with respect to one or more representative uses of at least one plant protection product containing Clonostachys rosea strain J1446 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 Clonostachys rosea strain J1446.

                     (11)

                     The risk assessment for the renewal of the approval of Clonostachys rosea strain J1446 is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing Clonostachys rosea strain J1446 may be authorised. It is therefore appropriate not to maintain the restriction to use only as a fungicide.

                     (12)

                     The Commission further considers that Clonostachys rosea strain J1446 is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Clonostachys rosea strain J1446 is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009.

                     (13)

                     It is therefore appropriate to renew the approval of Clonostachys rosea strain J1446 as a low-risk substance.

                     (14)

                     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.

                     (15)

                     In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.

                     (16)

                     Commission Implementing Regulation (EU) 2018/917 (7) extended the approval period of Clonostachys rosea strain J1446 to 31 July 2019 in order to allow the renewal process to be completed before the expiry date of the approval of that substance. However, given that a decision on renewal has been taken ahead of this extended expiry date, this Regulation shall apply from 1 April 2019.

                     (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
            Renewal of the approval of active substance
            The approval of the active substance Clonostachys rosea strain J1446, 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 April 2019.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 30 January 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Directive 2005/2/EC of 19 January 2005 amending Council Directive 91/414/EEC to include Ampelomyces quisqualis and Gliocladium catenulatum as active substances (OJ L 20, 22.1.2005, p. 15).

            (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 Journal 2016;14(7):4517, 16 pp. Available online: www.efsa.europa.eu.

            (7)  Commission Implementing Regulation (EU) 2018/917 of 27 June 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, carvone, chlorpropham, cyazofamid, desmedipham, dimethoate, dimethomorph, diquat, ethephon, ethoprophos, etoxazole, famoxadone, fenamidone, fenamiphos, flumioxazine, fluoxastrobin, folpet, foramsulfuron, formetanate, Gliocladium catenulatum strain: J1446, isoxaflutole, metalaxyl-m, methiocarb, methoxyfenozide, metribuzin, milbemectin, oxasulfuron, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, pymetrozine and s-metolachlor (OJ L 163, 28.6.2018, p. 13).

            ANNEX I

                        Common Name, Identification Numbers

                        IUPAC Name

                        Purity (1)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                           Clonostachys rosea strain J1446
                        Accession number in the culture collection of the German Collection of Microorganisms and Cell Cultures (DSMZ): DSM 9212

                        Not applicable

                        Not applicable
                        Gliotoxin content: max. 50 μg/kg in the technical grade of the MCPA.

                        1 April 2019

                        31 March 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 Clonostachys rosea strain J1446, 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 specification of technical material as commercially manufactured in plant protection products, including full characterisation of potential metabolites of concern;

                                    —

                                    the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use;

                                    —

                                    the studies or information from the scientific literature recently made available in relation to antifungal susceptibility of Clonostachys rosea J1446.

                              Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbial contamination as referred to in the Working Document SANCO/12116/2012 (2).
                        Conditions of use shall include risk mitigation measures, where appropriate.

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

               (2)  https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf

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

                        (1)

                        in Part A, entry 98 on Gliocladium catenulatum strain J1446 is deleted;

                        (2)

                        in Part D, the following entry is added:

                                    ‘15

                                       Clonostachys rosea strain J1446
                                    Accession number in the culture collection of the German Collection of Microorganisms and Cell Cultures (DSMZ): DSM 9212

                                    Not applicable

                                    Not applicable
                                    Gliotoxin content: max. 50 μg/kg in the technical grade of the MCPA.

                                    1 April 2019

                                    31 March 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 Clonostachys rosea strain J1446, 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 specification of technical material as commercially manufactured in plant protection products, including full characterisation of potential metabolites of concern;

                                                —

                                                the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use;

                                                —

                                                the studies or information from the scientific literature recently made available in relation to antifungal susceptibility of Clonostachys rosea J1446.

                                          Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbial contamination as referred to in the Working Document SANCO/12116/2012 (*1).
                                    Conditions of use shall include risk mitigation measures, where appropriate.

               (*1)  https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf’


title: Commission Implementing Regulation (EU) 2019/295 of 20 February 2019 amending Implementing Regulation (EU) No 1011/2014 as regards changes to the model for the payment application including additional information concerning financial instruments and to the model for the accounts

text:
                  21.2.2019

                  EN

                  Official Journal of the European Union

                  L 50/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/295
         of 20 February 2019
         amending Implementing Regulation (EU) No 1011/2014 as regards changes to the model for the payment application including additional information concerning financial instruments and to the model for the accounts
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1303/2013 of the European Parliament and of the Council of 17 December 2013 laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund and repealing Council Regulation (EC) No 1083/2006 (1), and in particular Article 41(4), Article 131(6) and Article 137(3) thereof,
         Whereas:

                     (1)

                     Annex VI to Commission Implementing Regulation (EU) No 1011/2014 (2) sets out the model for the payment application including additional information concerning financial instruments in accordance with Article 131(6) of Regulation (EU) No 1303/2013. With regard to advances paid in the context of State aid, Appendix 2 to that Annex specifies what amount of those advances paid and then in turn covered or not by expenditure paid by beneficiaries within a given period should be included into the payment applications.

                     (2)

                     Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (3) amended the definition of ‘beneficiary’ in Regulation (EU) No 1303/2013. It also amended Article 131(3) of Regulation (EU) No 1303/2013, which now provides that in the case of State aid, the public contribution corresponding to the expenditure included in a payment application is to have been paid to the beneficiaries by the body granting the aid or, where Member States have decided that the beneficiary is the body granting the aid pursuant to point (a) of Article 2(10) of that Regulation, paid by the beneficiary to the body receiving the aid. Due to those changes, Appendix 2 to Annex VI to Implementing Regulation (EU) No 1011/2014 should be amended accordingly.

                     (3)

                     Annex VII to Implementing Regulation (EU) No 1011/2014 sets out the model for the accounts in accordance with Article 137(3) of Regulation (EU) No 1303/2013. With regard to advances paid in the context of State aid, Appendix 7 to that Annex specifies what amount of those advances paid and then in turn covered or not by expenditure paid by beneficiaries within a given period is to be included into the accounts.

                     (4)

                     With regard to the total amount of eligible expenditure entered into the accounting systems of the certifying authority which has been included in payment applications, point (a) of Article 137(1) of Regulation (EU) No 1303/2013 refers back to its Article 131. Due to the changes in Article 131(3) of that Regulation, Appendix 7 to Annex VII to Implementing Regulation (EU) No 1011/2014 should also be amended accordingly.

                     (5)

                     In order to ensure legal certainty and to limit discrepancies between the amended provisions of Regulation (EU) No 1303/2013 which apply from 2 August 2018 or earlier in accordance with Article 282 of Regulation (EU, Euratom) 2018/1046 and the provisions of this Regulation to a minimum, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union.

                     (6)

                     The measures provided for in this Regulation are in accordance with the opinion of the Coordination Committee for the European Structural and Investment Funds.

                     (7)

                     Implementing Regulation (EU) No 1011/2014 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annexes VI and VII to Implementing Regulation (EU) No 1011/2014 are amended in accordance with the Annex to this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 20 February 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 347, 20.12.2013, p. 320.

            (2)  Commission Implementing Regulation (EU) No 1011/2014 of 22 September 2014 laying down detailed rules for implementing Regulation (EU) No 1303/2013 of the European Parliament and of the Council as regards the models for submission of certain information to the Commission and the detailed rules concerning the exchanges of information between beneficiaries and managing authorities, certifying authorities, audit authorities and intermediate bodies (OJ L 286, 30.9.2014, p. 1).

            (3)  Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).

            ANNEX
            Annexes VI and VII are amended as follows:

                        (1)

                        in Annex VI, Appendix 2 is amended as follows:

                                    (a)

                                    the heading of column (B) is replaced by the following:
                                    ‘Amount which has been covered by expenditure paid by beneficiaries or, where Member States have decided that the beneficiary is the body granting the aid pursuant to point (a) of Article 2(10) of Regulation (EU) No 1303/2013, by the body receiving the aid, within three years of the payment of the advance’;

                                    (b)

                                    the heading of column (C) is replaced by the following:
                                    ‘Amount which has not been covered by expenditure paid by beneficiaries or, where Member States have decided that the beneficiary is the body granting the aid pursuant to point (a) of Article 2(10) of Regulation (EU) No 1303/2013, by the body receiving the aid, and for which the three year period has not yet elapsed’;

                        (2)

                        in Annex VII, Appendix 7 is amended as follows:

                                    (a)

                                    the heading of column (B) is replaced by the following:
                                    ‘Amount which has been covered by expenditure paid by beneficiaries or, where Member States have decided that the beneficiary is the body granting the aid pursuant to point (a) of Article 2(10) of Regulation (EU) No 1303/2013, by the body receiving the aid, within three years of the payment of the advance’;

                                    (b)

                                    the heading of column (C) is replaced by the following:
                                    ‘Amount which has not been covered by expenditure paid by beneficiaries or, where Member States have decided that the beneficiary is the body granting the aid pursuant to point (a) of Article 2(10) of Regulation (EU) No 1303/2013, by the body receiving the aid, and for which the three year period has not yet elapsed’.


title: Commission Implementing Regulation (EU) 2019/296 of 20 February 2019 correcting certain language versions of Implementing Regulation (EU) 2016/2286 laying down detailed rules on the application of fair use policy and on the methodology for assessing the sustainability of the abolition of retail roaming surcharges and on the application to be submitted by a roaming provider for the purposes of that assessment (Text with EEA relevance.)

text:
                  21.2.2019

                  EN

                  Official Journal of the European Union

                  L 50/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/296
         of 20 February 2019
         correcting certain language versions of Implementing Regulation (EU) 2016/2286 laying down detailed rules on the application of fair use policy and on the methodology for assessing the sustainability of the abolition of retail roaming surcharges and on the application to be submitted by a roaming provider for the purposes of that assessment
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 531/2012 of the European Parliament and of the Council of 13 June 2012 on roaming on public mobile communications networks within the Union (1), and in particular Article 6d(1) thereof,
         After consulting the Body of European Regulators for Electronic Communications,
         Whereas:

                     (1)

                     The Dutch, Greek and Portuguese language versions of Commission Implementing Regulation (EU) 2016/2286 (2) contain an error in the first subparagraph of Article 4(2) as regards the calculation of the minimum volume of data roaming retail services the roaming customer is to be able to consume when periodically travelling in the Union, in case a fair use policy is applied by the roaming provider.

                     (2)

                     The Dutch, Greek and Portuguese language versions of Implementing Regulation (EU) 2016/2286 should therefore be corrected accordingly. The other language versions are not affected.

                     (3)

                     The measures provided for in this Regulation are in accordance with the opinion of the Communications Committee,

               HAS ADOPTED THIS REGULATION:

            Article 1

               (does not concern the English language)

            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, 20 February 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 172, 30.6.2012, p. 10.

            (2)  Commission Implementing Regulation (EU) 2016/2286 of 15 December 2016 laying down detailed rules on the application of fair use policy and on the methodology for assessing the sustainability of the abolition of retail roaming surcharges and on the application to be submitted by a roaming provider for the purposes of that assessment (OJ L 344, 17.12.2016, p. 46).


title: Commission Implementing Regulation (EU) 2019/298 of 20 February 2019 amending Annex I to Regulation (EC) No 798/2008 as regards the entries for Belarus, Bosnia and Herzegovina and Japan in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into or transit through the Union (Text with EEA relevance.)

text:
                  21.2.2019

                  EN

                  Official Journal of the European Union

                  L 50/20

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/298
         of 20 February 2019
         amending Annex I to Regulation (EC) No 798/2008 as regards the entries for Belarus, Bosnia and Herzegovina and Japan in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into or transit through the Union
         (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 of Article 8, the first subparagraph of point 1 of Article 8, point 4 of Article 8 and Article 9(4)(c) thereof,
         Having regard to Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (2), and in particular Articles 23(1), 24(2) and 25(2) thereof,
         Whereas:

                     (1)

                     Commission Regulation (EC) No 798/2008 (3) lays down veterinary certification requirements for imports into and transit, including storage during transit, through the Union of poultry and poultry products (‘the commodities’). It provides that the commodities are only to be imported into and transit through the Union from the third countries, territories, zones or compartments listed in columns 1 and 3 of the table in Part 1 of Annex I thereto.

                     (2)

                     The entry for Belarus in the table in the Annex to Commission Implementing Regulation (EU) 2015/2258 (4) refers only to the authorisation of transit through Lithuania of eggs and egg products, omitting meat of poultry. At the same time, Article 18(2) of Regulation (EC) No 798/2008 and the additional guarantees in the entry for Belarus in column 5 of the table in Part 1 of Annex I to that Regulation authorise the transit through Lithuania of eggs, egg products and meat of poultry. Therefore, the entry for Belarus in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 should be amended to refer to the transit of eggs, egg products and meat of poultry.

                     (3)

                     Bosnia and Herzegovina has requested to be authorised for imports into and transit through the Union of meat of poultry and has submitted the relevant information. The Commission has carried out an audit in Bosnia and Herzegovina to evaluate the animal health controls in place for meat of poultry intended for export to the Union. Given the favourable outcome of that audit, it is appropriate to include that third country in the table in Part 1 of Annex I to Regulation (EC) No 798/2008.

                     (4)

                     Japan has requested to be authorised for imports into and transit through the Union of eggs and egg products and has submitted the relevant information. The Commission has carried out an audit in Japan to evaluate the animal health controls in place for eggs and egg products intended for export to the Union. Given the favourable outcome of that audit, it is appropriate to include that third country in the table in Part 1 of Annex I to Regulation (EC) No 798/2008.

                     (5)

                     Japan has submitted to the Commission their control programmes for Salmonella in laying flocks of Gallus gallus. Those control programmes were found to provide guarantees equivalent to the guarantees set out in Regulation (EC) No 2160/2003 of the European Parliament and of the Council (5) and have been approved. Therefore, Japan should be authorised for the import of class A eggs into the Union and the entry for Japan in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 should not include any prohibition in relation to that commodity.

                     (6)

                     Annex I to Regulation (EC) No 798/2008 should therefore be amended accordingly.

                     (7)

                     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
            Part 1 of Annex I to Regulation (EC) No 798/2008 is amended in accordance with the Annex to this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 20 February 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 18, 23.1.2003, p. 11.

            (2)  OJ L 343, 22.12.2009, p. 74.

            (3)  Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (OJ L 226, 23.8.2008, p. 1).

            (4)  Commission Implementing Regulation (EU) 2015/2258 of 4 December 2015 amending Regulation (EC) No 798/2008 as regards imports and transit of single consignments of less than 20 units of poultry other than ratites, hatching eggs and day-old chicks thereof (OJ L 321, 5.12.2015, p. 23).

            (5)  Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents (OJ L 325, 12.12.2003, p. 1).

            ANNEX
            Part 1 of Annex I to Regulation (EC) No 798/2008 is amended as follows:

                        (1)

                        the following entry for Bosnia and Herzegovina is inserted between the entry for Australia and the entry for Brazil:

                                    ISO code and name of third country or territory

                                    Code of third country, territory, zone or compartment

                                    Description of third country, territory, zone or compartment

                                    Veterinary certificate

                                    Specific conditions

                                    Specific conditions

                                    Avian influenza surveillance status

                                    Avian influenza vaccination status

                                    Salmonella Control Status (6)

                                    Model(s)

                                    Additional guarantees

                                    Closing date (1)

                                    Opening date (2)

                                    1

                                    2

                                    3

                                    4

                                    5

                                    6

                                    6A

                                    6B

                                    7

                                    8

                                    9

                                    ‘BA — Bosnia and Herzegovina

                                    BA-0

                                    Whole country

                                    POU’

                        (2)

                        the entry for Belarus is replaced by the following:

                                    ISO code and name of third country or territory

                                    Code of third country, territory, zone or compartment

                                    Description of third country, territory, zone or compartment

                                    Veterinary certificate

                                    Specific conditions

                                    Specific conditions

                                    Avian influenza surveillance status

                                    Avian influenza vaccination status

                                    Salmonella Control Status (6)

                                    Model(s)

                                    Additional guarantees

                                    Closing date (1)

                                    Opening date (2)

                                    1

                                    2

                                    3

                                    4

                                    5

                                    6

                                    6A

                                    6B

                                    7

                                    8

                                    9

                                    ‘BY — Belarus

                                    BY-0

                                    Whole country

                                    EP, E, POU
                                    (all three only for transit through Lithuania)

                                    IX’

                        (3)

                        the following entry for Japan is inserted between the entry for Iceland and the entry for the Republic of Korea:

                                    ISO code and name of third country or territory

                                    Code of third country, territory, zone or compartment

                                    Description of third country, territory, zone or compartment

                                    Veterinary certificate

                                    Specific conditions

                                    Specific conditions

                                    Avian influenza surveillance status

                                    Avian influenza vaccination status

                                    Salmonella Control Status (6)

                                    Model(s)

                                    Additional guarantees

                                    Closing date (1)

                                    Opening date (2)

                                    1

                                    2

                                    3

                                    4

                                    5

                                    6

                                    6A

                                    6B

                                    7

                                    8

                                    9

                                    ‘JP — Japan

                                    JP-0

                                    Whole country

                                    EP, E’