title: Commission Implementing Regulation (EU) 2019/364 of 13 December 2018 laying down implementing technical standards with regard to the format of applications for registration and extension of registration of trade repositories in accordance with Regulation (EU) 2015/2365 of the European Parliament and of the Council (Text with EEA relevance.)

text:
                  22.3.2019

                  EN

                  Official Journal of the European Union

                  L 81/125

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/364
         of 13 December 2018
         laying down implementing technical standards with regard to the format of applications for registration and extension of registration of trade repositories in accordance with Regulation (EU) 2015/2365 of the European Parliament and of the Council
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2365 of the European Parliament and of the Council of 25 November 2015 on transparency of securities financing transactions and of reuse and amending Regulation (EU) No 648/2012 (1), and in particular Article 5(8) thereof,
         Whereas:

                     (1)

                     A uniform format for applications to the European Securities and Markets Authority (ESMA) for registration and extension of registration of trade repositories should ensure that all information required pursuant to Commission Delegated Regulation (EU) 2019/359 (2) is submitted to, and easily identified by, ESMA.

                     (2)

                     In order to facilitate the identification of the information submitted by the trade repository, every document contained in the application should bear a unique reference number.

                     (3)

                     In accordance with Article 1(3) of Delegated Regulation (EU) 2019/359, where an applicant trade repository considers that a requirement of Delegated Regulation (EU) 2019/359 is not applicable to it, it must clearly indicate that requirement in its application and provide an explanation why such requirement does not apply. Those requirements and explanations should be clearly identified in the application for registration or extension of registration.

                     (4)

                     Any information submitted to ESMA in an application for registration or extension of registration of a trade repository should be provided in a durable medium as defined in Directive 2009/65/EC of the European Parliament and of the Council (3) to enable its storage for future use and reproduction.

                     (5)

                     This Regulation is based on the draft implementing technical standards submitted by ESMA to the European Commission, pursuant to the procedure in Article 15 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council (4).

                     (6)

                     ESMA has conducted open public consultations on these draft implementing technical standards, analysed the potential related costs and benefits and requested the opinion of the Securities and Markets Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1095/2010,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Format of the application for registration and extension of registration

               1.   An application for registration or extension of registration shall be submitted in the format set out in the Annex.

               2.   The trade repository shall give a unique reference number to each document it submits and shall clearly identify which specific requirement in Delegated Regulation (EU) 2019/359 the document refers to.

               3.   An application for registration or extension of registration shall clearly indicate the reasons why information referring to a certain requirement is not submitted.

               4.   An application for registration or extension of registration shall be submitted in a durable medium as defined in Article 2(1)(m) of Directive 2009/65/EC.

            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, 13 December 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 337, 23.12.2015, p. 1.

            (2)  Commission Delegated Regulation (EU) 2019/359 of 13 December 2018 supplementing Regulation (EU) 2015/2365 of the European Parliament and of the Council with regard to regulatory technical standards specifying the details of the application for registration and extension of registration as a trade repository (see page 45 of this Official Journal).

            (3)  Directive 2009/65/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (OJ L 302, 17.11.2009, p. 32).

            (4)  Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (OJ L 331, 15.12.2010, p. 84).

            ANNEX

                        FORMAT FOR AN APPLICATION FOR REGISTRATION OR EXTENSION OF REGISTRATION AS A TRADE REPOSITORY

                        GENERAL INFORMATION

                        Date of application

                        Corporate name of the trade repository

                        Legal address of the trade repository

                        The types of securities financing transactions for which the trade repository is applying to be registered

                        Name of the person responsible for the application

                        Contact details of the person responsible for the application

                        Name of the person(s) responsible for the compliance for the trade repository or involved in compliance assessments for the trade repository

                        Contact details of the person(s) responsible for the compliance for the trade repository or involved in compliance assessments for the trade repository

                        Identification of any parent company or any subsidiaries

                        DOCUMENT REFERENCES (1)

                        Article of (EU) 2019/359

                        Unique reference number of the document

                        Title of the document

                        Chapter/section/page of the document where the information is provided or reason why the information is not provided

               (1)  For all information required in Commission Delegated Regulation (EU) 2019/359 with the exception of points (a), (c) and (g) of Article 1 thereof.


title: Commission Implementing Regulation (EU) 2019/365 of 13 December 2018 laying down implementing technical standards with regard to the procedures and forms for exchange of information on sanctions, measures and investigations in accordance with Regulation (EU) 2015/2365 of the European Parliament and of the Council (Text with EEA relevance.)

text:
                  22.3.2019

                  EN

                  Official Journal of the European Union

                  L 81/128

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/365
         of 13 December 2018
         laying down implementing technical standards with regard to the procedures and forms for exchange of information on sanctions, measures and investigations in accordance with Regulation (EU) 2015/2365 of the European Parliament and of the Council
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2365 of the European Parliament and of the Council of 25 November 2015 on transparency of securities financing transactions and of reuse and amending Regulation (EU) No 648/2012 (1), and in particular Article 25(4) thereof,
         Whereas:

                     (1)

                     To ensure that the European Securities and Markets Authority (ESMA) receives complete and accurate information regarding administrative and criminal measures imposed and criminal investigations undertaken in relation to infringements of Regulation (EU) 2015/2365, common procedures and forms for submitting that information should be set out.

                     (2)

                     In order to avoid potential double entries and conflicts of competence between multiple reporting authorities within a Member State, a single contact point within each Member State should be designated for the exchange of information with ESMA.

                     (3)

                     With a view to including meaningful information in the annual reports on sanctions, measures and investigations to be published by ESMA, the information reported by competent authorities should clearly indicate which provisions of Regulation (EU) 2015/2365 have been infringed by means of specific forms.

                     (4)

                     The competent authority should provide ESMA with a copy of the decision imposing the administrative sanction or measure and a clear summary of the essential elements of that decision. However, in order to limit the reporting burden, when a particular administrative sanction or measure has already been reported to ESMA under Article 25(3) of Regulation (EU) 2015/2365, the competent authority should only be required to make a clear reference to that sanction or measure.

                     (5)

                     This Regulation is based on the draft implementing technical standards submitted by ESMA to the European Commission, pursuant to the procedure in Article 15 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council (2).

                     (6)

                     In accordance with Article 15 of Regulation (EU) No 1095/2010, ESMA did not conduct open public consultations on the draft implementing technical standards on which this Regulation is based, nor did it analyse potential related costs and benefits of introducing the standard forms and procedures for the relevant competent authorities, as this would have been disproportionate in relation to their scope and impact, taking into account that the addressees of the implementing technical standards are the national competent authorities of the Member States and not market participants.

                     (7)

                     ESMA requested the opinion of the Securities and Markets Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1095/2010,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Contact points

               1.   The European Securities and Markets Authority (ESMA) shall designate a single contact point for receiving the information referred to in paragraphs 1 and 2 of Article 25 of Regulation (EU) 2015/2365 and for all communications on any issue relating to the reception of such information. Details of the contact point shall be made available on ESMA's website.

               2.   The competent authorities of each Member State shall designate a single contact point for that Member State for all communications relating to the provision of the information referred to in paragraphs 1 and 2 of Article 25 of Regulation (EU) 2015/2365. Competent authorities shall notify ESMA of those contact points.

            Article 2
            Annual submission of aggregated information

               1.   The contact points designated by competent authorities for each Member State pursuant to Article 1(2) shall provide ESMA with the information referred to in Article 25(1) of Regulation (EU) 2015/2365 using the form in Annex I to this Regulation. Copies of decisions imposing administrative sanctions and other administrative measures and summaries of such decisions shall be provided, unless the sanction or measure has already been reported to ESMA under Article 25(3) of Regulation (EU) 2015/2365. Copies of decisions shall be submitted in email attachments accompanying the form.

               2.   The contact points designated by competent authorities for each Member State pursuant to Article 1(2) shall provide ESMA with the information referred to in Article 25(2) of Regulation (EU) 2015/2365 using the form in Annex II to this Regulation.

               3.   The forms referred to in paragraphs 1 and 2 shall cover a reporting period of one calendar year and shall, together with any attachments, be electronically completed and submitted by email to ESMA's contact point no later than 31 March the following year.
               The first submission of the forms referred to in paragraphs 1 and 2 shall be made in 2018 for the calendar years 2016 and 2017.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 13 December 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 337, 23.12.2015, p. 1.

            (2)  Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority (OJ L 331, 15.12.2010, p. 84).

            ANNEX I
            Text of image

               Form for submission of aggregated and granular information regarding all administrative sanctions and other administrative measures imposed
               Aggregated and granular information regarding all administrative sanctions and other administrative measures imposed by [name of the competent authority] in [year] under Article … of …
               FROM:
               Member State:
               Competent authority:
               Address:
               (Contact details of the designated contact person)
               Name:
               Telephone:
               Email:
               TO:
               ESMA
               (Contact details of the designated contact person)
               Name:
               Telephone:
               Email:
               Reporting period:
               Dear [insert appropriate name]
               In accordance with Article 25(1) of Regulation (EU) 2015/2365, we wish to provide ESMA with aggregated and granular information regarding all administrative sanctions and other administrative measures imposed by [name of the competent authority] in [year].

            Text of image

               The aggregated information is set out in the following table:
               Provisions of Regulation (EU) 2015/2365 in respect of which administrative sanctions/measures have been imposed
               Number of sanctions/measures imposed in the reporting period
               Pecuniary amount of financial sanctions imposed in the reporting period
               [number of the Article, paragraph, subparagraph]
               [number of sanctions/measures]
               [pecuniary amount of financial sanctions (1)]
               Total sanctions/measures (2)
               [total number of sanctions/measures]
               [total pecuniary amount of financial sanctions]
               The granular information in respect of each of the measures and sanctions included in the table above is provided as follows.
               First, we have already reported the following measures and sanctions imposed in [year] to ESMA in accordance with Article 25(3) of Regulation (EU) 2015/2365:
               [List of each measure and sanction reported in the relevant period]
               Secondly, copies of the decision/(s) for the following measures and sanctions imposed in [INSERT YEAR] are provided in separate email attachment/(s) accompanying this form:
               [List of each measure and sanction for which a decision is being provided]
               Thirdly, summaries of the following measures and sanctions are provided below:
               [List in numerical order (1., 2., 3., et seq.) of each measure and sanction for which a summary is then provided below.]
               1. [Reference to the first measure/sanction listed above]
               [Summary of measure/sanction]
               2. [Reference to the second measure/sanction listed above]
               [Summary of measure/sanction]
               [For the third and each subsequent summary being provided, continue in numerical order by using the format above.]
               Yours sincerely,
               [signature]
               (1) Please insert a value in Euro or in national currency. Where the relevant sanction refers not only to breaches of the relevant Article of Regulation (EU) 2015/2365, but also to other provisions, add the mention ‘AGGREGATED FIGURE’ to each value.
               (2) As sanctions/measures imposed may be based on more than one legislative provision, the sum of the different rows (number of sanctions or measures/pecuniary amount of financial sanctions) may not correspond to the total number of sanctions/measures or to the total value of fines imposed.

            ANNEX II
            Text of image

               Form for submitting anonymised and aggregated data on all criminal investigations undertaken and criminal sanctions imposed
               Anonymised and aggregated data on all criminal investigations undertaken and criminal sanctions imposed in [year] under Article … of …
               FROM:
               Member State:
               Competent authority:
               Address:
               (Contact details of the designated contact person)
               Name:
               Telephone:
               Email:
               TO:
               ESMA
               (Contact details of the designated contact person)
               Name:
               Telephone:
               Email:
               Reporting period:
               Dear [insert appropriate name]
               In accordance with Article 25(2) of Regulation (EU) 2015/2365, we wish to provide ESMA with anonymised and aggregated information regarding all criminal investigations undertaken and criminal sanctions imposed in [Member State] in [year].

            Text of image

               The aggregated information is set out in the following tables:
               Criminal investigations:
               Provisions of Regulation (EU) 2015/2365 pursuant to which criminal investigations have been undertaken.
               Number of criminal investigations in the reporting period
               [number of the Article, paragraph, subparagraph]
               [number of criminal investigations]
               Total criminal investigations
               [total number of criminal investigations (1)]
               Criminal sanctions imposed:
               Provisions of Regulation (EU) 2015/2365 in respect of which criminal sanctions have been imposed.
               Number of criminal sanctions imposed in the reporting period
               Value of fines imposed in the reporting period
               [number of the Article, paragraph, subparagraph]
               [number of criminal sanctions]
               [value of fines (2)]
               Total criminal sanctions (3)
               [total number of criminal sanctions]
               [total value of fines]
               Yours sincerely,
               [signature]
               (1) As criminal investigations may be based on more than one legislative provision, the sum of the different rows may not correspond to the total number of criminal investigations.
               (2) Please insert a value in euro or in national currency. Where the relevant fine refers not only to breaches of the relevant article of Regulation (EU) 2015/2365, but also to other provisions, add the mention ‘AGGREGATED FIGURE’ to each value.
               (3) As criminal sanctions imposed may be based on more than one legislative provision, the sum of the different rows (number of criminal sanctions/value) may not correspond to the total number of criminal sanctions/total value of fines imposed.


title: Commission Implementing Regulation (EU) 2019/586 of 11 April 2019 amending Part 1 of Annex I to Commission Regulation (EC) No 798/2008 as regards the inclusion of the United Kingdom of Great Britain and Northern Ireland and certain of its Crown Dependencies in the list of third countries, territories, zones or compartments authorised for the introduction into the Union of consignments of poultry and poultry products (Text with EEA relevance.)

text:
                  11.4.2019

                  EN

                  Official Journal of the European Union

                  LI 100/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/586
         of 11 April 2019
         amending Part 1 of Annex I to Commission Regulation (EC) No 798/2008 as regards the inclusion of the United Kingdom of Great Britain and Northern Ireland and certain of its Crown Dependencies in the list of third countries, territories, zones or compartments authorised for the introduction into the Union of consignments of poultry and poultry products
         (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 points (1) and (4) of Article 8 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 Article 23(1) thereof,
         Whereas:

                     (1)

                     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 (TEU). On 22 March 2019, the European Council adopted Decision (EU) 2019/476 (3) extending the period under Article 50(3) TEU in agreement with the United Kingdom. In accordance with that Decision, in the event that the Withdrawal Agreement is not approved by the House of Commons by 29 March 2019 at the latest, the period provided for in Article 50(3) TEU is extended until 12 April 2019. As the Withdrawal Agreement has not been approved by 29 March 2019, Union law will cease to apply to and in the United Kingdom from 13 April 2019 (‘the withdrawal date’).

                     (2)

                     Commission Regulation (EC) No 798/2008 (4) lays down a list of third countries, territories, zones or compartments from which poultry and poultry products (the commodities) may be imported into and transit through the Union and the veterinary certification requirements. 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.

                     (3)

                     The United Kingdom of Great Britain and Northern Ireland has provided the necessary guarantees for that country and certain of its Crown Dependencies to comply with the conditions laid down in Regulation (EC) No 798/2008 for the introduction into the Union of consignments of the commodities from the withdrawal date, by continuing to comply with Union legislation for an initial period of at least nine months.

                     (4)

                     Therefore, taking into account these specific guarantees provided by the United Kingdom of Great Britain and Northern Ireland, and in order to avoid any unnecessary disruption to trade after the withdrawal date, the United Kingdom of Great Britain and Northern Ireland and certain of its Crown Dependencies should be included in the list of third countries, territories, zones or compartments set out in Part 1 of Annex I to Regulation (EC) No 798/2008, authorised for the introduction into the Union of consignments of the commodities.

                     (5)

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

                     (6)

                     This Regulation should apply from 13 April 2019, unless Union law continues to apply to and in the United Kingdom of Great Britain and Northern Ireland on that date.

                     (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 shall be amended in accordance with the text in 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.
            It shall apply from 13 April 2019.
            However, it shall not apply if Union law continues to apply to and in the United Kingdom of Great Britain and Northern Ireland on that date.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 11 April 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)  European Council Decision (EU) 2019/476 taken in agreement with the United Kingdom of 22 March 2019 extending the period under Article 50(3)TEU (OJ L 80 I, 22.3.2019, p. 1).

            (4)  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).

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

                        (a)

                        the following lines are inserted after the entry for China:

                                    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

                                    Model(s)

                                    Additional guarantees

                                    Closing date

                                    Opening date

                                    1

                                    2

                                    3

                                    4

                                    5

                                    6

                                    6A

                                    6B

                                    7

                                    8

                                    9

                                    ‘GB-United Kingdom of Great Britain and Northern Ireland

                                    GB-0

                                    Whole country

                                    SPF

                                    BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20,

                                    A

                                    WGM

                                    EP, E, POU, RAT

                                    GG-Guernsey

                                    GG-0

                                    Whole country

                                    SPF

                                    BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20,

                                    A’

                                    WGM

                                    EP, E, POU, RAT

                        (b)

                        the following line is inserted after the entry for Iceland:

                                    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

                                    Model(s)

                                    Additional guarantees

                                    Closing date

                                    Opening date

                                    1

                                    2

                                    3

                                    4

                                    5

                                    6

                                    6A

                                    6B

                                    7

                                    8

                                    9

                                    ‘JE-Jersey

                                    JE-0

                                    Whole country

                                    SPF

                                    BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20,

                                    A’

                                    WGM

                                    EP, E, POU, RAT


title: Commission Implementing Regulation (EU) 2019/587 of 11 April 2019 amending Annex I to Regulation (EC) No 119/2009 as regards the inclusion of the United Kingdom of Great Britain and Northern Ireland and certain of its Crown Dependencies in the list of third countries or parts thereof authorised for the introduction into the Union of consignments of meat of wild leporidae, of certain wild land mammals and of farmed rabbits (Text with EEA relevance.)

text:
                  11.4.2019

                  EN

                  Official Journal of the European Union

                  LI 100/8

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/587
         of 11 April 2019
         amending Annex I to Regulation (EC) No 119/2009 as regards the inclusion of the United Kingdom of Great Britain and Northern Ireland and certain of its Crown Dependencies in the list of third countries or parts thereof authorised for the introduction into the Union of consignments of meat of wild leporidae, of certain wild land mammals and of farmed rabbits
         (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) and point (4) of Article 8 and Article 9(4) thereof,
         Whereas:

                     (1)

                     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 (TEU). On 22 March 2019, the European Council adopted Decision (EU) 2019/476 (2) extending the period under Article 50(3) TEU in agreement with the United Kingdom. In accordance with that Decision, in the event that the Withdrawal Agreement is not approved by the House of Commons by 29 March 2019 at the latest, the period provided for in Article 50(3) TEU is extended until 12 April 2019. As the Withdrawal Agreement has not been approved by 29 March 2019, Union law will cease to apply to and in the United Kingdom from 13 April 2019 (‘the withdrawal date’).

                     (2)

                     Commission Regulation (EC) No 119/2009 (3) lays down the public and animal health conditions and certification requirements for the introduction into the Union of consignments of meat of wild leporidae, of certain wild land mammals and of farmed rabbits and the list of third countries and parts thereof from which the introduction into the Union of such consignments is authorised.

                     (3)

                     The United Kingdom of Great Britain and Northern Ireland has provided the necessary guarantees for that country and certain of its Crown Dependencies to comply with the conditions laid down in Regulation (EC) No 119/2009 for the introduction into the Union of consignments of meat of wild leporidae, of certain wild land mammals and of farmed rabbits following the withdrawal date by continuing to comply with Union legislation for an initial period of at least nine months.

                     (4)

                     Therefore, taking into account these specific guarantees provided by the United Kingdom of Great Britain and Northern Ireland, and in order to avoid any unnecessary disruption to trade after the withdrawal date, the United Kingdom and certain of its Crown Dependencies should be included in the list of third countries and parts thereof set out in Annex I to Regulation (EC) No 119/2009 authorised for the introduction into the Union of consignments of meat of wild leporidae, of certain wild land mammals and of farmed rabbits.

                     (5)

                     Annex I to Regulation (EC) No 119/2009 should therefore be amended accordingly.

                     (6)

                     This Regulation should apply from 13 April 2019, unless Union law continues to apply to and in the United Kingdom of Great Britain and Northern Ireland on that date.

                     (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 119/2009 is 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.
            It shall apply from 13 April 2019.
            However, it shall not apply if Union law continues to apply to and in the United Kingdom of Great Britain and Northern Ireland on that date.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 11 April 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  European Council Decision (EU) 2019/476 taken in agreement with the United Kingdom of 22 March 2019 extending the period under Article 50(3)TEU (OJ L 80 I, 22.3.2019, p. 1).

            (3)  Commission Regulation (EC) No 119/2009 of 9 February 2009 laying down a list of third countries or parts thereof, for imports into, or transit through, the Community of meat of wild leporidae, of certain wild land mammals and of farmed rabbits and the veterinary certification requirements (OJ L 39, 10.2.2009, p. 12).

            ANNEX
            The table set out in Part 1 of Annex I to Regulation (EC) No 119/2009 is amended as follows:

                        (a)

                        the following lines are inserted after the entry for Canada:

                                    ‘United Kingdom of Great Britain and Northern Ireland

                                    GB

                                    WL

                                    RM

                                    WM

                                    Guernsey

                                    GG

                                    WL

                                    RM

                                    WM’

                        (b)

                        the following line is inserted after the entry for Greenland:

                                    ‘Jersey

                                    JE

                                    WL

                                    RM

                                    WM’


title: Commission Implementing Regulation (EU) 2019/588 of 11 April 2019 amending Annex I to Regulation (EU) No 605/2010 as regards the inclusion of the United Kingdom of Great Britain and Northern Ireland and certain of its Crown Dependencies in the list of third countries or parts thereof authorised for the introduction into the Union of consignments of raw milk, dairy products, colostrum and colostrum-based products intended for human consumption (Text with EEA relevance.)

text:
                  11.4.2019

                  EN

                  Official Journal of the European Union

                  LI 100/11

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/588
         of 11 April 2019
         amending Annex I to Regulation (EU) No 605/2010 as regards the inclusion of the United Kingdom of Great Britain and Northern Ireland and certain of its Crown Dependencies in the list of third countries or parts thereof authorised for the introduction into the Union of consignments of raw milk, dairy products, colostrum and colostrum-based products intended for human consumption
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (1), and in particular the introductory phrase of Article 8, the first subparagraph of point (1) and point (4) of Article 8 and Article 9(4) thereof,
         Whereas:

                     (1)

                     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 (TEU). On 22 March 2019, the European Council adopted Decision (EU) 2019/476 (2) extending the period under Article 50(3) TEU in agreement with the United Kingdom. In accordance with that Decision, in the event that the Withdrawal Agreement is not approved by the House of Commons by 29 March 2019 at the latest, the period provided for in Article 50(3) TEU is extended until 12 April 2019. As the Withdrawal Agreement has not been approved by 29 March 2019, Union law will cease to apply to and in the United Kingdom from 13 April 2019 (‘the withdrawal date’).

                     (2)

                     Commission Regulation (EU) No 605/2010 (3) lays down the public and animal health conditions and certification requirements for the introduction into the Union of consignments of raw milk, dairy products, colostrum and colostrum-based products intended for human consumption, and the list of third countries or parts thereof from which the introduction into the Union of such consignments is authorised.

                     (3)

                     The United Kingdom of Great Britain and Northern Ireland has provided the necessary guarantees for that country and certain of its Crown Dependencies to comply with the conditions laid down in Regulation (EU) No 605/2010 for the introduction into the Union of consignments of raw milk, dairy products, colostrum and colostrum-based products intended for human consumption from the withdrawal date, by continuing to comply with Union legislation for an initial period of at least nine months.

                     (4)

                     Therefore, taking into account these specific guarantees provided by the United Kingdom of Great Britain and Northern Ireland, and in order to avoid any unnecessary disruption to trade after the withdrawal date, the United Kingdom and certain of its Crown Dependencies should be included in columns ‘A’, ‘B’ and ‘C’ in the list of third countries, territories and parts thereof set out in Annex I to Regulation (EU) No 605/2010 authorised for the introduction into the Union of consignments of raw milk, dairy products, colostrum and colostrum-based products intended for human consumption.

                     (5)

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

                     (6)

                     This Regulation should apply from 13 April 2019, unless Union law continues to apply to and in the United Kingdom of Great Britain and Northern Ireland on that date.

                     (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
            Annex I to Regulation (EU) No 605/2010 is 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.
            It shall apply from 13 April 2019.
            However, it shall not apply if Union law continues to apply to and in the United Kingdom of Great Britain and Northern Ireland on that date.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 11 April 2019

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  European Council Decision (EU) 2019/476 taken in agreement with the United Kingdom of 22 March 2019 extending the period under Article 50(3)TEU (OJ L 80 I, 22.3.2019, p. 1).

            (3)  Commission Regulation (EU) No 605/2010 of 2 July 2010 laying down animal and public health and veterinary certification conditions for the introduction into the European Union of raw milk and dairy products intended for human consumption (OJ L 175, 10.7.2010, p. 1).

            ANNEX
            The table set out in Annex I to Regulation (EU) No 605/2010 is amended as follows:

                        (a)

                        the following lines are inserted after the entry for Ethiopia:

                                    ‘GB

                                    United Kingdom of Great Britain and Northern Ireland

                                    +

                                    +

                                    +

                                    GG

                                    Guernsey

                                    +

                                    +

                                    +’

                        (b)

                        the following line is inserted after the entry for Iceland:

                                    ‘JE

                                    Jersey

                                    +

                                    +

                                    +’


title: Commission Implementing Regulation (EU) 2019/589 of 11 April 2019 amending Annex III to Regulation (EC) No 1251/2008 as regards the inclusion of the United Kingdom of Great Britain and Northern Ireland and certain of its Crown Dependencies in the list of third countries, territories, zones or compartments authorised for the introduction into the European Union of consignments of aquaculture animals (Text with EEA relevance.)

text:
                  11.4.2019

                  EN

                  Official Journal of the European Union

                  LI 100/14

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/589
         of 11 April 2019
         amending Annex III to Regulation (EC) No 1251/2008 as regards the inclusion of the United Kingdom of Great Britain and Northern Ireland and certain of its Crown Dependencies in the list of third countries, territories, zones or compartments authorised for the introduction into the European Union of consignments of aquaculture animals
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals (1), and in particular Article 22 and Article 61(3) thereof,
         Whereas:

                     (1)

                     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 (TEU). On 22 March 2019, the European Council adopted Decision (EU) 2019/476 (2) extending the period under Article 50(3) TEU in agreement with the United Kingdom. In accordance with that Decision, in the event that the Withdrawal Agreement is not approved by the House of Commons by 29 March 2019 at the latest, the period provided for in Article 50(3) TEU is extended until 12 April 2019. As the Withdrawal Agreement has not been approved by 29 March 2019, Union law will cease to apply to and in the United Kingdom from 13 April 2019 (‘the withdrawal date’).

                     (2)

                     Annex III to Commission Regulation (EC) No 1251/2008 (3) establishes a list of third countries, territories, zones or compartments authorised for the introduction into the Union of aquaculture animals.

                     (3)

                     (3) The United Kingdom of Great Britain and Northern Ireland has provided the necessary guarantees for that country and certain of its Crown Dependencies to comply with the conditions laid down in Regulation (EC) No 1251/2008 for the introduction into the Union of consignments of aquaculture animals from the withdrawal date, by continuing to comply with Union legislation for an initial period of at least nine months.

                     (4)

                     (4) Therefore, taking into account these specific guarantees provided by the United Kingdom of Great Britain and Northern Ireland, and in order to avoid any unnecessary disruption to trade after the withdrawal date, the United Kingdom and certain of its Crown Dependencies, should be included in the list of third countries, territories, zones or compartments set out in Annex III to Regulation (EC) No 1251/2008 authorised for the introduction into the Union of consignments of aquaculture animals.

                     (5)

                     Annex III to Regulation (EC) No 1251/2008 should therefore be amended accordingly.

                     (6)

                     This Regulation should apply from 13 April 2019, unless Union law continues to apply to and in the United Kingdom of Great Britain and Northern Ireland on that date.

                     (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
            Annex III to Regulation (EC) No 1251/2008 is 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.
            It shall apply from 13 April 2019.
            However, it shall not apply if Union law continues to apply to and in the United Kingdom of Great Britain and Northern Ireland on that date.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 11 April 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 328, 24.11.2006, p. 14.

            (2)  European Council Decision (EU) 2019/476 taken in agreement with the United Kingdom of 22 March 2019 extending the period under Article 50(3)TEU (OJ L 80 I, 22.3.2019, p. 1).

            (3)  Commission Regulation (EC) No 1251/2008 of 12 December 2008 implementing Council Directive 2006/88/EC as regards conditions and certification requirements for the placing on the market and the import into the Community of aquaculture animals and products thereof and laying down a list of vector species (OJ L 337, 16.12.2008, p. 41).

            ANNEX
            The table set out in Annex III to Regulation (EC) No 1251/2008 is amended as follows:

                        (a)

                        the following lines are inserted after the entry for Cook Islands:

                                    ‘GB

                                    United Kingdom of Great Britain and Northern Ireland

                                    X

                                    X

                                    X

                                    Whole country

                                    GG

                                    Guernsey

                                    X

                                    X

                                    X

                                    Whole country’

                        (b)

                        the following line is inserted after the entry for Israel:

                                    ‘JE

                                    Jersey

                                    X

                                    X

                                    X

                                    Whole country’


title: Commission Implementing Regulation (EU) 2019/590 of 11 April 2019 amending Annex I to Implementing Regulation (EU) 2018/659 as regards the inclusion of the United Kingdom of Great Britain and Northern Ireland and certain of its Crown Dependencies in the list of third countries and parts of the territory of third countries from which the entry into the Union of live equidae and semen, ova and embryos of equidae is authorised (Text with EEA relevance.)

text:
                  11.4.2019

                  EN

                  Official Journal of the European Union

                  LI 100/17

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/590
         of 11 April 2019
         amending Annex I to Implementing Regulation (EU) 2018/659 as regards the inclusion of the United Kingdom of Great Britain and Northern Ireland and certain of its Crown Dependencies in the list of third countries and parts of the territory of third countries from which the entry into the Union of live equidae and semen, ova and embryos of equidae is authorised
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC (1), and in particular Article 3(2) and Article 9(1)(c) thereof,
         Having regard to Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC (2), and in particular Article 17(3) thereof,
         Having regard to Council Directive 2009/156/EC of 30 November 2009 on animal health conditions governing the movement and importation from third countries of equidae (3), and in particular Article 2(i), Article 12(1), (4) and (5), Article 13(2), Articles 15, 16, 17 and 19 thereof,
         Whereas:

                     (1)

                     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 (TEU). On 22 March 2019, the European Council adopted Decision (EU) 2019/476 (4) extending the period under Article 50(3) TEU in agreement with the United Kingdom. In accordance with that Decision, in the event that the Withdrawal Agreement is not approved by the House of Commons by 29 March 2019 at the latest, the period provided for in Article 50(3) TEU is extended until 12 April 2019. As the Withdrawal Agreement has not been approved by 29 March 2019, Union law will cease to apply to and in the United Kingdom from 13 April 2019 (‘the withdrawal date’).

                     (2)

                     Directive 2009/156/EC lays down the animal health requirements governing imports into the Union of equidae. It provides that only equidae that come from a third country or part of a third country on a list of third countries drawn up in accordance with that Directive, and accompanied by a health certificate corresponding to a model also drawn up in accordance with that Directive, may be imported into the Union.

                     (3)

                     Directive 92/65/EEC lays down the animal health requirements governing imports into the Union of semen, ova and embryos of the equine species. It provides that only commodities that come from a third country or part of a third country on a list of third countries drawn up in accordance with that Directive and accompanied by a health certificate corresponding to a model also drawn up in accordance with that Directive, may be imported into the Union. The health certificate must attest that the commodities come from approved collection and storage centres or collection and production teams offering guarantees at least equivalent to those established in Annex D(I) to that Directive.

                     (4)

                     Commission Implementing Regulation (EU) 2018/659 (5) establishes inter alia the list of third countries and parts of the territory of third countries from which Member States authorise the entry of live equidae and semen, ova and embryos of equidae.

                     (5)

                     The United Kingdom of Great Britain and Northern Ireland has provided the necessary guarantees for that country and certain of its Crown Dependencies to comply with the conditions laid down in Directives 2009/156/EC and 92/65/EEC, and in Implementing Regulation (EU) 2018/659 for the entry into the Union of consignments of equidae and of semen, ova and embryos of equidae from the withdrawal date by continuing to comply with Union legislation for an initial period of at least nine months.

                     (6)

                     Therefore, taking into account these specific guarantees provided by the United Kingdom of Great Britain and Northern Ireland and in order to avoid any unnecessary disruption of trade after the withdrawal date, the United Kingdom of Great Britain and Northern Ireland and certain of its Crown Dependencies should be included in the list of third countries and parts of the territory of third countries set out in Annex I to Implementing Regulation (EU) 2018/659 from which the entry of live equidae and semen, ova and embryos of equidae is authorised.

                     (7)

                     As regards the health status of equidae in the United Kingdom of Great Britain and Northern Ireland and the Crown Dependencies, these countries should be assigned to sanitary group A, and all types of entry and the entry of all categories of equidae should be allowed.

                     (8)

                     Annex I to Implementing Regulation (EU) 2018/659 should therefore be amended accordingly.

                     (9)

                     This Regulation should apply from 13 April 2019, unless Union law continues to apply to and in the United Kingdom of Great Britain and Northern Ireland on that date.

                     (10)

                     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
            Annex I to Implementing Regulation (EU) 2018/659 is 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.
            It shall apply from 13 April 2019.
            However, it shall not apply if Union law continues to apply to and in the United Kingdom of Great Britain and Northern Ireland on that date.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 11 April 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 268, 24.9.1991, p. 56.

            (2)  OJ L 268, 14.9.1992, p. 54.

            (3)  OJ L 192, 23.7.2010, p. 1.

            (4)  European Council Decision (EU) 2019/476 taken in agreement with the United Kingdom of 22 March 2019 extending the period under Article 50(3) TEU (OJ L 80 I, 22.3.2019, p. 1).

            (5)  Commission Implementing Regulation (EU) 2018/659 of 12 April 2018 on the conditions for the entry into the Union of live equidae and of semen, ova and embryos of equidae (OJ L 110, 30.4.2018, p. 1).

            ANNEX
            The table set out in Annex I to Implementing Regulation (EU) 2018/659 is amended as follows:

                        (a)

                        the following lines are inserted after the entry for the Falkland Islands:

                                    ‘GB

                                    United Kingdom of Great Britain and Northern Ireland

                                    GB-0

                                    Whole country

                                    A

                                    X

                                    X

                                    X

                                    X

                                    X

                                    X

                                    X

                                    X

                                    X

                                    X

                                    GG

                                    Guernsey

                                    GG-0

                                    Whole country

                                    A

                                    X

                                    X

                                    X

                                    X

                                    X

                                    X

                                    X

                                    X

                                    X

                                    X’

                        (b)

                        the following line is inserted after the entry for Iceland:

                                    ‘JE

                                    Jersey

                                    JE-0

                                    Whole country

                                    A

                                    X

                                    X

                                    X

                                    X

                                    X

                                    X

                                    X

                                    X

                                    X

                                    X’


title: Commission Implementing Regulation (EU) 2019/1085 of 25 June 2019 renewing the approval of the active substance 1-methylcyclopropene, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011, and amending the Annex to Commission Implementing Regulation (EU) 2015/408 (Text with EEA relevance.)

text:
                  26.6.2019

                  EN

                  Official Journal of the European Union

                  L 171/110

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1085
         of 25 June 2019
         renewing the approval of the active substance 1-methylcyclopropene, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011, and amending the Annex to Commission Implementing Regulation (EU) 2015/408
         (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) in conjunction with Article 78(2) thereof,
         Whereas:

                     (1)

                     Commission Directive 2006/19/EC (2) included 1-methylcyclopropene 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 1-methylcyclopropene, 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 1-methylcyclopropene 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 April 2017.

                     (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 28 May 2018, the Authority communicated to the Commission its conclusion (6) on whether 1-methylcyclopropene 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 1-methylcyclopropene to the Standing Committee on Plants, Animals, Food and Feed on 12 and 13 December 2018.

                     (9)

                     As regards the new criteria to identify endocrine disrupting properties introduced by Commission Regulation (EU) 2018/605 (7), the conclusion of the Authority indicates that it is highly unlikely that 1-methylcyclopropene is an endocrine disrupter via the estrogenic, androgenic, thyroidogenic and steroidogenic modalities. On the basis of the available data and current knowledge (8), the Authority concludes that 1-methylcyclopropene is unlikely to have endocrine disrupting properties. Thus, the Commission considers that 1-methylcyclopropene 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 1-methylcyclopropene that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

                     (11)

                     In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 of that Regulation 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 maintain the restriction of use as plant growth regulator for post harvest storage in sealable warehouses only.

                     (12)

                     Commission Implementing Regulation (EU) 2015/408 (9) listed 1-methylcyclopropene as a candidate for substitution based on its Acceptable Daily Intake being significantly lower than that of the majority of the approved active substances within its respective group of substances or use categories.

                     (13)

                     Based on the new toxicological data provided in the dossier for the renewal process, the Authority concluded on a significant increase of the Acceptable Daily Intake. As a consequence, the Commission considers that 1-methylcyclopropene does not fulfil the criteria listed in point 4 of Annex II to Regulation (EC) No 1107/2009 and therefore, 1-methylcyclopropene no longer fulfils the criteria to be considered a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Accordingly, 1-methylcyclopropene should be deleted from the Annex to Implementing Regulation (EU) 2015/408.

                     (14)

                     It is therefore appropriate to renew the approval of 1-methylcyclopropene.

                     (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) 2018/1262 (10) extended the expiry date of 1-methylcyclopropene 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 that extended expiry date, this Regulation should apply from 1 August 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 1-methylcyclopropene, 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
            Amendment to Implementing Regulation (EU) 2015/408
            The entry for 1-methylcyclopropene is deleted from the Annex to Implementing Regulation (EU) 2015/408.

            Article 4
            Entry into force and date of application
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            It shall apply from 1 August 2019.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 25 June 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Directive 2006/19/EC of 14 February 2006 amending Council Directive 91/414/EEC to include 1-methylcyclopropene as active substance (OJ L 44, 15.2.2006, 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 2018;16(7):5308. Available online: www.efsa.europa.eu EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the pesticide risk assessment of the active substance 1-methylcyclopropene.

            (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)  OECD Conceptual Framework, as analysed in the EFSA Scientific Opinion on the hazard assessment of endocrine disruptors, EFSA Scientific Committee, 2013.

            (9)  Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing Article 80(7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution (OJ L 67, 12.3.2015, p. 18).

            (10)  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

                        1-methylcyclopropene
                        CAS No 3100-04-7
                        CIPAC No 767

                        1-methylcyclopropene

                        ≥ 980 g/kg (technical concentrate)
                        The following impurities are of toxicological concern and must not exceed the following levels in the technical material (technical concentrate):

                                    —

                                    1-chloro-2-methylpropene: maximum of 0,2 g/kg,

                                    —

                                    3-chloro-2-methylpropene: maximum of 0,2 g/kg.

                              For 1-methylcyclopropene generated in situ, Heptane and methylcyclohexane are toxicologically relevant impurities. These impurities should remain below 10 %.

                        1 August 2019

                        31 July 2034

                        Only uses as plant growth regulator for post-harvest storage in sealable warehouse may be authorised.
                        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 1-methycyclopropene, and in particular Appendices I and II thereto, shall be taken into account.

               (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 117 on 1-methylcyclopropene is deleted;

                        (2)

                        in Part B, the following entry is added:

                                    No

                                    Common Name, Identification Numbers

                                    IUPAC Name

                                    Purity (1)

                                    Date of approval

                                    Expiration of approval

                                    Specific provisions

                                    ‘136

                                    1-methylcyclopropene
                                    CAS No 3100-04-7
                                    CIPAC No 767

                                    1-methylcyclopropene

                                    ≥ 980 g/kg (technical concentrate)
                                    The following impurities are of toxicological concern and must not exceed the following levels in the technical material (technical concentrate):

                                                —

                                                1-chloro-2-methylpropene: maximum of 0,2 g/kg,

                                                —

                                                3-chloro-2-methylpropene: maximum of 0,2 g/kg.

                                          For 1-methylcyclopropene generated in situ, Heptane and methylcyclohexane are toxicologically relevant impurities. These impurities should remain below 10 %.

                                    1 August 2019

                                    31 July 2034

                                    Only uses as plant growth regulator for post-harvest storage in sealable warehouse may be authorised.
                                    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 1-methycyclopropene, and in particular Appendices I and II thereto, shall be taken into account.’

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