title: Commission Implementing Regulation (EU) 2019/1706 of 10 October 2019 amending Implementing Regulation (EU) 2017/325 imposing a definitive anti-dumping duty on imports of high tenacity yarns of polyesters originating in the People’s Republic of China following an expiry review pursuant to Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the Council

text:
                  11.10.2019

                  EN

                  Official Journal of the European Union

                  L 260/42

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1706
         of 10 October 2019
         amending Implementing Regulation (EU) 2017/325 imposing a definitive anti-dumping duty on imports of high tenacity yarns of polyesters originating in the People’s Republic of China following an expiry review pursuant to Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the Council
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (1) (‘the basic Regulation’),
         Having regard to Commission Implementing Regulation (EU) 2017/325 of 24 February 2017 imposing a definitive anti-dumping duty on imports of high tenacity yarns of polyesters originating in the People’s Republic of China following an expiry review pursuant to Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the Council (2), as amended by Implementing Regulation (EU) 2017/2368 (3), and in particular, Article 1(5) thereof,
         Whereas:
         A.   MEASURES IN FORCE

                     (1)

                     With Implementing Regulation (EU) No 1105/2010 (4), the Council imposed a definitive anti-dumping duty on imports into the Union of high tenacity yarns of polyesters originating in the People’s Republic of China (‘the product concerned’).

                     (2)

                     In the original investigation, sampling was applied for investigating the exporting producers in the People’s Republic of China (‘PRC’) in accordance with Article 17 of the basic Regulation.

                     (3)

                     The Council imposed individual anti-dumping duty rates ranging from 5,1 % to 9,8 % on imports of the product concerned for the sampled exporting producers from the PRC. For the cooperating exporting producers that were not included in the sample, a duty rate of 5,3 % was imposed. Furthermore, a country-wide duty rate of 9,8 % was imposed on imports of high tenacity yarns of polyesters from all other Chinese companies.

                     (4)

                     Following an expiry review based on Article 11(2) of the basic Regulation, the original measures were prolonged for five years by Implementing Regulation (EU) 2017/325 (‘the expiry review Regulation’).

                     (5)

                     Implementing Regulation (EU) 2017/2368 amended Implementing Regulation (EU) 2017/325 to include Article 1(5) allowing exporting producers to request a new exporting producer treatment.

                     (6)

                     Article 1(5) of Implementing Regulation (EU) 2017/325, as amended by Implementing Regulation (EU) 2017/2368 states that where any party from the PRC provides sufficient evidence to the Commission that:

                                 (a)

                                 it did not export to the Union the product concerned during the period of the original investigation (1 July 2008 - 30 June 2009);

                                 (b)

                                 it is not related to an exporter or producer subject to the measures imposed by this Regulation; and

                                 (c)

                                 it has either actually exported to the Union the product concerned after the original investigation period or has entered into an irrevocable contractual obligation to export a significant quantity to the Union after the end of the period of the original investigation;

                           then the Annex of Implementing Regulation (EU) 2017/325 can be amended to attribute to that party the duty rate applicable to the cooperating companies not included in the sample, namely the weighted average duty rate of 5,3 %.

               B.   REQUESTS FOR NEW EXPORTING PRODUCER TREATMENT

                     (7)

                     The company Wuxi Solead Technology Development Co., Ltd, came forward after the publication of Implementing Regulation (EU) 2017/325 and submitted a request to the Commission to be granted new exporting producer treatment and hence be subject to the duty rate applicable to the cooperating companies in the PRC not included in the sample, i.e. 5,3 %.

                     (8)

                     In order to determine whether the applicant fulfilled the criteria for being granted new exporting producer treatment, set out above in recital 6, the Commission first sent a questionnaire to the applicant requesting evidence showing that it meets these criteria. After an initial analysis of the questionnaire response, the Commission sent out a letter requesting further information to which the applicant responded.

                     (9)

                     The Commission verified all information it deemed necessary for determining whether the applicant meets the criteria. The Commission also informed the Union industry of this new exporting producer treatment request.

                     (10)

                     The Union industry did not comment on the request.

               C.   ANALYSIS OF THE REQUEST

                     (11)

                     With regard to criterion (a), the Commission examined the applicant’s business licence, Articles of Association and audited financial statements, and determined that the applicant was founded on 11 February 2015. Therefore, in light of the available information, the Commission established that the applicant did not export the product concerned during the original investigation (1 July 2008 to 30 June 2009). Hence, the applicant complies with criterion (a) as set out in recital 6.

                     (12)

                     With regard to the criterion that the applicant is not related to any exporters or producers that are subject to anti-dumping measures imposed by the original Regulation (criterion (b)), the Commission examined the relations of its shareholders and its related export sales company. The Commission established from the information at its disposal that the applicant is not related to any exporter or producer that is subject to the anti-dumping measures. Therefore, the applicant complies with criterion (b) as set out in recital 6.

                     (13)

                     With regard to the criterion (c), that the applicant has actually exported to the Union the product concerned or has entered into an irrevocable contractual obligation to export a significant quantity to the Union after the original investigation period, the applicant provided evidence of exports of the product concerned to Croatia after the original investigation period. The Croatian customs authorities also reported the transaction in the database created under Article 14.6 of the basic Regulation. Therefore, the company complies with criterion (c) set out in recital 6.

               D.   CONCLUSION

                     (14)

                     The Commission concluded that the applicant meets the three criteria to be considered as a new exporting producer. Therefore, its name should be added to the list of cooperating companies not included in the sample in Annex to Implementing Regulation (EU) 2017/325.

                     (15)

                     Therefore, Implementing Regulation (EU) 2017/325 should be amended accordingly.

               E.   DISCLOSURE

                     (16)

                     The Commission informed the applicant and the Union industry of these findings and gave an opportunity to comment.

                     (17)

                     The parties were granted the possibility to submit comments. [No comments were received.]

                     (18)

                     This Regulation is in accordance with the opinion of the Committee established by Article 15(1) of Regulation (EU) 2016/1036,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The following company shall be added to the list of exporting producers from the People’s Republic of China in the Annex of Commission Implementing Regulation (EU) 2017/325:

                        Company name

                        City

                        ‘Wuxi Solead Technology Development Co., Ltd,

                        Xinjian Town’

            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, 10 October 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 176, 30.6.2016, p. 21.

            (2)  OJ L 49, 25.2.2017, p. 6.

            (3)  OJ L 337, 19.12.2017, p. 24.

            (4)  OJ L 315, 1.12.2010, p. 1.


title: Commission Implementing Regulation (EU) 2019/1756 of 23 October 2019 amending Annex V to Regulation (EC) No 136/2004 as regards the inclusion of the United Kingdom of Great Britain and Northern Ireland in the list of third countries authorised for the introduction into the Union of consignments of hay and straw (Text with EEA relevance)

text:
                  24.10.2019

                  EN

                  Official Journal of the European Union

                  L 270/57

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1756
         of 23 October 2019
         amending Annex V to Regulation (EC) No 136/2004 as regards the inclusion of the United Kingdom of Great Britain and Northern Ireland in the list of third countries authorised for the introduction into the Union of consignments of hay and straw
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (1), and in particular Article 19(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 11 April 2019, the European Council adopted Decision (EU) 2019/584 (2) extending the period under Article 50(3) TEU in agreement with the United Kingdom. In accordance with that Decision, the period provided for in Article 50(3) TEU has been further extended until 31 October 2019. Union law will therefore cease to apply to and in the United Kingdom from 1 November 2019 (‘the withdrawal date’).

                     (2)

                     Directive 97/78/EC lays down the principles governing the organisation of veterinary checks on products entering the Union from third countries. Article 19(1) of that Directive provides that the Commission is to draw up a list of plant products which are to be subjected to border veterinary checks since they can present a risk of spreading infectious or contagious animal diseases to the Union, and a list of the third countries which may be authorised to export those plant products to the Union.

                     (3)

                     Accordingly, Annex IV to Commission Regulation (EC) No 136/2004 (3) lists hay and straw as plant products subject to border veterinary checks, while Annex V to that Regulation lists the countries from which Member States are authorised to import hay and straw.

                     (4)

                     The United Kingdom of Great Britain and Northern Ireland has provided the necessary guarantees for that country to comply with the conditions laid down in Regulation (EC) No 136/2004 for the introduction into the Union of consignments of commodities of hay and straw from the withdrawal date by continuing to comply with Union legislation for an initial period of at least nine months.

                     (5)

                     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 should be included in the list of countries set out in Annex V to Regulation (EC) No 136/2004 authorised for the introduction into the Union of consignments of hay and straw.

                     (6)

                     Annex V to Regulation (EC) No 136/2004 should therefore be amended accordingly.

                     (7)

                     This Regulation should apply from 1 November 2019, unless Union law continues to apply to and in the United Kingdom of Great Britain and Northern Ireland on that date.

                     (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
            Annex V to Regulation (EC) No 136/2004 shall be 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 1 November 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, 23 October 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 24, 30.1.1998, p. 9.

            (2)  European Council Decision (EU) 2019/584 taken in agreement with the United Kingdom of 11 April 2019 extending the period under Article 50(3) TEU (OJ L 101, 11.4.2019, p. 1).

            (3)  Commission Regulation (EC) No 136/2004 of 22 January 2004 laying down procedures for veterinary checks at Community border inspection posts on products imported from third countries (OJ L 21, 28.1.2004, p. 11).

            ANNEX
            The following line is inserted after the entry for Chile in Annex V to Regulation (EC) No 136/2004:

                           ‘GB

                           United Kingdom of Great Britain and Northern Ireland’


title: Commission Implementing Regulation (EU) 2019/1811 of 23 October 2019 concerning the classification of certain goods in the Combined Nomenclature

text:
                  30.10.2019

                  EN

                  Official Journal of the European Union

                  L 278/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1811
         of 23 October 2019
         concerning the classification of certain goods in the Combined Nomenclature
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (1), and in particular Article 57(4) and Article 58(2) thereof,
         Whereas:

                     (1)

                     In order to ensure uniform application of the Combined Nomenclature annexed to Council Regulation (EEC) No 2658/87 (2), it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

                     (2)

                     Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

                     (3)

                     Pursuant to those general rules, the goods described in column (1) of the table set out in the Annex should be classified under the CN code indicated in column (2), by virtue of the reasons set out in column (3) of that table.

                     (4)

                     It is appropriate to provide that binding tariff information issued in respect of the goods concerned by this Regulation which does not conform to this Regulation may, for a certain period, continue to be invoked by the holder in accordance with Article 34(9) of Regulation (EU) No 952/2013. That period should be set at three months.

                     (5)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The goods described in column (1) of the table set out in the Annex shall be classified within the Combined Nomenclature under the CN code indicated in column (2) of that table.

            Article 2
            Binding tariff information which does not conform to this Regulation may continue to be invoked in accordance with Article 34(9) of Regulation (EU) No 952/2013 for a period of three months from the date of entry into force of this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 23 October 2019.

                  For the Commission,

                  On behalf of the President,

               Stephen QUEST

                  Director-General

                  Directorate-General for Taxation and Customs Union

            (1)  OJ L 269, 10.10.2013, p. 1.

            (2)  Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

               ANNEX

                        Description of the goods

                        Classification (CN-code)

                        Reasons

                        (1)

                        (2)

                        (3)

                        A mobile, self-balanced, electrically powered machine, a so called ‘telepresence robot’. It consists of the following main components in a single housing with two wheels mounted on an axle:

                                    —

                                    an accelerometer and a gyroscope,

                                    —

                                    an electric motor,

                                    —

                                    a Bluetooth module,

                                    —

                                    a rechargeable battery.

                              The article has a power connection for recharging the battery, a status light and a vertical telescopic pole with motorised height control. The pole has a detachable holder for a tablet computer (‘tablet’) on the top. The holder is equipped with a USB port for charging the tablet.
                        The article can be remotely controlled only by means of a compatible device (tablet, etc.) with wireless communication functions using Bluetooth.
                        The article is used to transport and lift or lower the tablet and to supply the tablet with electricity.
                        See image (*1).

                        8428 90 90

                        Classification is determined by general rules 1 and 6 for the interpretation of the Combined Nomenclature, note 3 to Section XVI and by the wording of CN codes 8428, 8428 90  and 8428 90 90 .
                        The article merely moves the tablet and supplies it with electricity; it does not enable the tablet to perform operations other than that for which it is designed. Therefore it is neither adapting the tablet for a particular operation, nor increasing its range of operations, nor performing a particular service relative to the main function of the tablet (see judgment of 16 June 2011, Unomedical, C-152/10, EU:C:2011:402, paragraph 29, and see also the Harmonised System Explanatory Notes to heading 8473, second paragraph).
                        Consequently, classification under heading 8473 as an accessory for use solely or principally with machines of headings 8470 to 8472 is excluded.
                        Classification under heading 8479 or 8543 is excluded as the article performs several functions of machines referred to in the headings of Chapter 84 or 85 (Section XVI), such as a lifting and handling function (transporting and lifting or lowering a tablet), to provide current to a device and a communication function using the Bluetooth protocol.
                        By virtue of note 3 to Section XVI, it is to be classified as being that apparatus which performs the principal function.
                        The article is designed to transport and lift or lower a tablet and, consequently, this is its principal function within the meaning of note 3 to Section XVI. The other functions are ancillary.
                        The article is therefore to be classified under CN code 8428 90 90  as other lifting, handling, loading or unloading machinery.

               (*1)  The image is purely for information.


title: Commission Implementing Regulation (EU) 2019/1812 of 23 October 2019 concerning the classification of certain goods in the Combined Nomenclature

text:
                  30.10.2019

                  EN

                  Official Journal of the European Union

                  L 278/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1812
         of 23 October 2019
         concerning the classification of certain goods in the Combined Nomenclature
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (1), and in particular Article 57(4) and Article 58(2) thereof,
         Whereas:

                     (1)

                     In order to ensure uniform application of the Combined Nomenclature annexed to Council Regulation (EEC) No 2658/87 (2), it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

                     (2)

                     Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

                     (3)

                     Pursuant to those general rules, the goods described in column (1) of the table set out in the Annex should be classified under the CN code indicated in column (2), by virtue of the reasons set out in column (3) of that table.

                     (4)

                     It is appropriate to provide that binding tariff information issued in respect of the goods concerned by this Regulation which does not conform to this Regulation may, for a certain period, continue to be invoked by the holder in accordance with Article 34(9) of Regulation (EU) No 952/2013. That period should be set at three months.

                     (5)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The goods described in column (1) of the table set out in the Annex shall be classified within the Combined Nomenclature under the CN code indicated in column (2) of that table.

            Article 2
            Binding tariff information which does not conform to this Regulation may continue to be invoked in accordance with Article 34(9) of Regulation (EU) No 952/2013 for a period of three months from the date of entry into force of this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 23 October 2019.

                  For the Commission,

                  On behalf of the President,

               Stephen QUEST

                  Director-General

                  Directorate-General for Taxation and Customs Union

            (1)  OJ L 269, 10.10.2013, p. 1.

            (2)  Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

            ANNEX

                        Description of the goods

                        Classification (CN-code)

                        Reasons

                        (1)

                        (2)

                        (3)

                        A reusable water bottle made of clear borosilicate glass, fitted with a screw cap made of stainless steel. The cap has an inner o-ring made of silicone that provides impermeable sealing. The bottle has a carrying loop attached to the cap and a removable anti-slip silicone sleeve for convenient use.
                        The bottle is of a height of approximately 220 mm and a diameter of 60 mm. The diameter of the neck is approximately 30 mm. The bottle has a capacity of up to 0,6 l.

                            (*1) See images.

                        7013 99 00

                        Classification is determined by general rules 1 and 6 for the interpretation of the Combined Nomenclature and by the wording of CN codes 7013 and 7013 99 00 .
                        Classification under heading 7010 as bottles, flasks and other containers, of glass, of a kind used for the conveyance or packing of goods, is excluded, as the article is not commonly used commercially (see also the Harmonized System Explanatory Notes (HSEN) to heading 7010, first paragraph, HSEN to heading 7013, last paragraph, point (b), and also the Harmonized System classification opinion 3924.90/2).
                        The article is therefore to be classified under CN code 7013 99 00  as other glassware of a kind used for table, kitchen, toilet, office, indoor decoration or similar purposes.

               (*1)  The images are purely for information.


title: Commission Implementing Regulation (EU) 2019/1826 of 25 October 2019 entering a name in the register of protected designations of origin and protected geographical indications (Kaimiškas Jovarų alus (PGI))

text:
                  31.10.2019

                  EN

                  Official Journal of the European Union

                  L 279/22

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1826
         of 25 October 2019
         entering a name in the register of protected designations of origin and protected geographical indications (‘Kaimiškas Jovarų alus’ (PGI))
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
         Whereas:

                     (1)

                     Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Lithuania’s application to register the name ‘Kaimiškas Jovarų alus’ was published in the Official Journal of the European Union (2).

                     (2)

                     As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Kaimiškas Jovarų alus’ should therefore be entered in the register,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The name ‘Kaimiškas Jovarų alus’ (PGI) is hereby entered in the register.
            The name specified in the first paragraph denotes a product in Class 2.1. – Beer, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

            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, 25 October 2019.

                  For the Commission,

                  On behalf of the President,

               Phil HOGAN

                  Member of the Commission

            (1)  OJ L 343, 14.12.2012, p. 1.

            (2)  OJ C 217, 28.6.2019, p. 5.

            (3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).


title: Commission Implementing Regulation (EU) 2019/1853 of 5 November 2019 amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq

text:
                  6.11.2019

                  EN

                  Official Journal of the European Union

                  L 285/7

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1853
         of 5 November 2019
         amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 1210/2003 of 7 July 2003 concerning certain specific restrictions on economic and financial relations with Iraq and repealing Regulation (EC) No 2465/96 (1), and in particular Article 11(b) thereof,
         Whereas:

                     (1)

                     Annex III to Regulation (EC) No 1210/2003 lists public bodies, corporations and agencies and natural and legal persons, bodies and entities of the previous government of Iraq covered by the freezing of funds and economic resources that were located outside Iraq on 22 May 2003 under that Regulation.

                     (2)

                     On 30 October 2019, the Sanctions Committee of the United Nations Security Council decided to remove two entries from the list of persons or entities to whom the freezing of funds and economic resources should apply.

                     (3)

                     Annex III to Regulation (EC) No 1210/2003 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex III to Regulation (EC) No 1210/2003 is amended as set out 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.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 5 November 2019.

                  For the Commission,

                  On behalf of the President,

                  Head of the Service for Foreign Policy Instruments

            (1)  OJ L 169, 8.7.2003, p. 6.

            ANNEX
            In Annex III to Regulation (EC) No 1210/2003, the following entries are deleted:

                           ‘183.

                           STATE ORGANISATION FOR IRRIGATION PROJECTS (alias GENERAL ESTABLISHMENT FOR IRRIGATION PROJECTS). Addresses: (a) Northgate, Karanteena, P.O. Box 148, Baghdad, Iraq; (b) Al-Muadham, near Engineering College, P.O. Box 14186, Baghdad, Iraq.

                           184.

                           STATE ORGANISATION FOR LAND RECLAMATION (alias (a) GENERAL ESTABLISHMENT FOR PLANTATION AND DEVELOPMENT OF THE RECLAIMED LANDS, (b) GENERAL ESTABLISHMENT FOR EXECUTION OF LAND RECLAMATION CONTRACTS, (c) GENERAL ESTABLISHMENT FOR LAND RECLAMATION OF CENTRAL AND NORTHERN AREAS, (d) GENERAL ESTABLISHMENT FOR LAND RECLAMATION OF SOUTHERN AREAS). Addresses: (a) Amiriya, Abu Gharib, P.O. Box 6161, Baghdad, Iraq; (b) P.O. Box 6061, Aamrlya 7, Nisan, Iraq; (c) P.O. Box 609, Al-Sadoon St., Baghdad, Iraq; (d) P.O. Box 27, Wasit Province, Kut, Iraq.’


title: Council Implementing Regulation (EU) 2019/1943 of 25 November 2019 implementing Regulation (EU) 2016/1686 imposing additional restrictive measures directed against ISIL (Da’esh) and Al-Qaeda and natural and legal persons, entities or bodies associated with them

text:
                  25.11.2019

                  EN

                  Official Journal of the European Union

                  LI 303/1

         COUNCIL IMPLEMENTING REGULATION (EU) 2019/1943
         of 25 November 2019
         implementing Regulation (EU) 2016/1686
         imposing additional restrictive measures directed against ISIL (Da’esh) and Al-Qaeda
         and natural and legal persons, entities or bodies associated with them
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EU) 2016/1686 of 20 September 2016 imposing additional restrictive measures directed against ISIL (Da’esh) and Al-Qaeda and natural and legal persons, entities or bodies associated with them (1), and in particular Article 4(1) thereof,
         Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 20 September 2016 the Council adopted Regulation (EU) 2016/1686.

                     (2)

                     In view of the continued threat posed by ISIL (Da’esh) and Al-Qaeda and natural and legal persons, entities or bodies associated with them, one person should be added to the list of natural and legal persons, entities and bodies set out in Annex I to Regulation (EU) 2016/1686.

                     (3)

                     Regulation (EU) 2016/1686 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex I to Regulation (EU) 2016/1686 is amended as set out in the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the date 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, 25 November 2019.

                  For the Council

                  The President

               F. MOGHERINI

            (1)  OJ L 255, 21.9.2016, p. 1.

            ANNEX
            The following entry is added to the list set out in Annex I to Regulation (EU) 2016/1686:

                        ‘5.

                        Guillaume PIROTTE; date of birth: 7 June 1994; place of birth: Grasse (France); nationality: French.’


title: Commission Implementing Regulation (EU) 2020/7 of 19 December 2019 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (Huile d’olive de la Vallée des Baux-de-Provence (PDO))

text:
                  8.1.2020

                  EN

                  Official Journal of the European Union

                  L 4/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/7
         of 19 December 2019
         approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Huile d’olive de la Vallée des Baux-de-Provence’ (PDO))
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
         Whereas:

                     (1)

                     Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined France’s application for the approval of amendments to the specification for the protected designation of origin ‘Huile d’olive de la Vallée des Baux-de-Provence’, registered under Commission Regulation (EC) No 1187/2000 (2).

                     (2)

                     Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union (3) as required by Article 50(2)(a) of that Regulation.

                     (3)

                     As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Huile d’olive de la Vallée des Baux-de-Provence’ (PDO) are hereby approved.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 19 December 2019.

                  For the Commission,

                  On behalf of the President,

               Janusz WOJCIECHOWSKI

                  Member of the Commission

            (1)  OJ L 343, 14.12.2012, p. 1.

            (2)  Commission Regulation (EC) No 1187/2000 of 5 June 2000 supplementing the Annex to Regulation (EC) No 2400/96 on the entry of certain names in the ‘Register of protected designations of origin and protected geographical indications’ provided for in Council Regulation (EEC) No 2081/92 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (OJ L 133, 6.6.2000, p. 19).

            (3)  OJ C 279, 19.8.2019, p. 3.


title: Commission Implementing Regulation (EU) 2020/16 of 10 January 2020 authorising the placing on the market of nicotinamide riboside chloride as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

text:
                  13.1.2020

                  EN

                  Official Journal of the European Union

                  L 7/6

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/16
         of 10 January 2020
         authorising the placing on the market of nicotinamide riboside chloride as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.

                     (2)

                     Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) establishing a Union list of authorised novel foods was adopted.

                     (3)

                     Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to submit a draft implementing act authorising placing on the Union market of a novel food and on the updating of the Union list.

                     (4)

                     On 10 May 2018, the company ChromaDex Inc. (‘the Applicant’) made a request to the Commission to place nicotinamide riboside chloride on the Union market as a novel food within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested for nicotinamide riboside chloride to be used as a source of niacin in food supplements intended for the general adult population at the maximum use levels of 300 mg/day. Furthermore, the application requested for nicotinamide riboside to be also added to the list of niacin forms specified in Annex II of Directive 2002/46/EC of the European Parliament and of the Council (3) as a source of niacin.

                     (5)

                     The Applicant also made a request to the Commission for the protection of proprietary data for a number of studies submitted in support of the application namely, an in vitro study evaluating the metabolism of nicotinamide riboside in blood (Study No 160312) (4); an oral 7-day dose range finding toxicity study in juvenile dogs (StudyNo 17-921) (5); a hERG screening assay (Study No 20151223) (6); a 28-day repeat-dose oral toxicity study in juvenile dogs (Study No 17-940) (7); a 90-day repeated-dose oral toxicity study in Sprague–Dawley rats (Study No S14022) (8); a reproductive toxicity study (Study No G10959) (9); and a developmental toxicity study in rats (Study No G10957) (10).

                     (6)

                     The Commission consulted the European Food Safety Authority (‘Authority’) on 8 October 2018, asking it to provide a scientific opinion on the safety of nicotinamide riboside as a novel food in accordance with Article 10(3) of Regulation (EU) 2015/2283, and on the assessment for the intended use as a food supplement.

                     (7)

                     On 4 July 2019, the Authority adopted the scientific opinion on the ‘Safety of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC’ (11). That scientific opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (8)

                     In its opinion, the Authority concluded that nicotinamide riboside chloride is safe when used in food supplements at the maximum level of 300 mg/day for the general adult population, excluding pregnant and lactating women, and at the maximum level of 230 mg/day for pregnant and lactating women.

                     (9)

                     The opinion of the Authority gives sufficient grounds to establish that nicotinamide riboside chloride under the assessed conditions of use complies with Article 12(1) of Regulation (EU) 2015/2283.

                     (10)

                     The Authority considered that, in elaborating its opinion on nicotinamide riboside chloride as a novel food, data from the in vitro study evaluating the metabolism of nicotinamide riboside in blood (Study No 160312) served as a basis to assess the bioavailability of nicotinamide, while data from five toxicity studies (an oral 7-day dose range finding toxicity study in juvenile dogs (Study No 17-921); a 28-day repeat-dose oral toxicity study in juvenile dogs (Study No 17-940); a 90-day repeated-dose oral toxicity study in Sprague–Dawley rats (Study No S14022); a reproductive toxicity study (Study No G10959); and a developmental toxicity study in rats (Study No G10957)) served as a basis to assess the safety of nicotinamide riboside chloride. Therefore, it is considered that the conclusions on the safety of nicotinamide riboside chloride could not have been reached without the data from the unpublished reports of those studies.

                     (11)

                     The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over the in vitro study evaluating the metabolism of nicotinamide riboside in blood and the five toxicity studies, and to clarify their claim to an exclusive right of reference to these studies, as referred to in Article 26(2)(b) of Regulation (EU) 2015/2283.

                     (12)

                     The Applicant declared that, at the time the application was submitted, it held ownership and proprietary exclusive right of reference to these studies, and that therefore third parties cannot lawfully access or use these studies or refer to that data.

                     (13)

                     The Commission assessed all the information provided by the Applicant and considered that the Applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the in vitro study evaluating the metabolism of nicotinamide riboside in blood and the five toxicity studies contained in the Applicant’s file should not be used by the Authority for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation. Accordingly, the placing on the market within the Union of nicotinamide riboside chloride should be restricted to the Applicant for that period.

                     (14)

                     However, restricting the authorisation of nicotinamide riboside chloride and of the reference to the studies contained in the Applicant’s file for the sole use of the Applicant does not prevent other applicants from applying for an authorisation to place on the market the same novel food provided that, their application is based on legally obtained information supporting the authorisation under this Regulation.

                     (15)

                     The Directive 2002/46/EC lays down requirements on food supplements. The use of nicotinamide riboside chloride should be authorised without prejudice to the requirements of that Directive.

                     (16)

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

               HAS ADOPTED THIS REGULATION:

            Article 1

               1.   Nicotinamide riboside chloride as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.

               2.   For a period of five years from the date of entry into force of this Regulation only the initial Applicant:

                           —

                           Company: ChromaDex Inc.;

                           —

                           Address: 10900 Wilshire Boulevard Suite 600, Los Angeles, CA 90024 USA,

                     is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for the novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of ChromaDex Inc.

               3.   The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex.

               4.   The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC.

            Article 2
            The studies contained in the application file on the basis of which the novel food referred to in Article 1 has been assessed by the Authority, claimed by the Applicant as proprietary and without which the novel food could not have been authorised, shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of ChromaDex Inc.

            Article 3
            The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

            Article 4
            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, 10 January 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 327, 11.12.2015, p. 1.

            (2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

            (3)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

            (4)  Keystone Bioanalytical Inc., The Metabolism of Nicotinamide Riboside in Human Blood (Study No 160312), 10 January 2018, unpublished.

            (5)  Experimur, Oral 7-Day Dose Range Finding Toxicity Study in Juvenile Dogs (Study No 17-921), 27 November 2017, unpublished.

            (6)  IPS Therapeutique, Inc., Evaluation of the effects of Nicotinamide Riboside Chloride on the human potassium channel using human embryonic kidney (HEK) 293 cells transfected with a human ether-a-go-go-related gene (hERG), 25 March 2016, unpublished.

            (7)  Experimur, Oral 28-Day Toxicity Study in Juvenile Dogs (Study No 17-940), 20 February 2018, unpublished.

            (8)  Syngene International Limited, Comparative 90-Day Oral Toxicity Study in Sprague Dawley Rats (Study No S14022), 12 May 2015, unpublished.

            (9)  Advinus Therapeutics Limited, Nicotinamide riboside chloride: one generation reproduction toxicity study through diet in Sprague-Dawley rats (Study No G10959), 21 November 2016, unpublished.

            (10)  Advinus Therapeutics Limited, Nicotinamide riboside chloride: embryo-fetal developmental toxicity study in Sprague-Dawley rats by oral route (Study No G10957), 30 September 2016.

            (11)  EFSA Journal 2019;17(8):5775.

            ANNEX
            The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

               (1)
               the following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order:

                           Authorised novel food

                           Conditions under which the novel food may be used

                           Additional specific labelling requirements

                           Other requirements

                           Data Protection

                           ‘Nicotinamide riboside chloride

                              Specified food category

                              Maximum levels

                           The designation of the novel food on the labelling of the foodstuffs containing it shall be “Nicotinamide riboside chloride”

                           Authorised on 20 February 2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
                           Applicant: ChromaDex Inc., 10900 Wilshire Boulevard Suite 600, Los Angeles, CA 90024 USA. During the period of data protection, the novel food is authorised for placing on the market within the Union only by ChromaDex Inc. unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of ChromaDex Inc.
                           End date of the data protection: 20 February 2025.’

                           Food Supplements as defined in Directive 2002/46/EC

                           300 mg/day for the general adult population, excluding pregnant and lactating women
                           230 mg/day for pregnant and lactating women

               (2)
               the following entry is inserted in Table 2 (Specifications) in alphabetical order:

                           Authorised Novel Food

                           Specification

                           ‘Nicotinamide riboside chloride

                              Description/Definition:

                           The novel food is a synthetic form of nicotinamide riboside.
                           The novel food contains ≥ 90 % nicotinamide riboside chloride, predominantly in its β form, the remaining components being residual solvents, reaction by-products and degradation products.
                           Nicotinamide riboside chloride:
                           CAS number: 23111-00-4
                           EC number: 807-820-5
                           IUPAC name: 1-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]pyridin-1-ium-3-carboxamide;chloride
                           Chemical formula: C11H15N2O5Cl
                           Molecular weight: 290,7 g/mol

                              Characteristics/Composition:

                           Colour: White to light brown
                           Form: Powder
                           Identification: Conforms by NMR (nuclear magnetic resonance)
                           Nicotinamide riboside chloride: ≥ 90 %
                           Water content: ≤ 2 %

                              Residual solvents:

                           Acetone: ≤ 5 000  mg/kg
                           Methanol: ≤ 1 000  mg/kg
                           Acetonitrile: ≤ 50 mg/kg
                           Methyl tert-butyl ether: ≤ 500 mg/kg

                              Reaction by-products:

                           Methyl acetate: ≤ 1 000  mg/kg
                           Acetamide: ≤ 27 mg/kg
                           Acetic acid: ≤ 5 000  mg/kg

                              Heavy metals:

                           Arsenic: ≤ 1 mg/kg

                              Microbiological criteria:

                           Total Plate Count: ≤ 1 000  CFU/g
                           Yeast and Mould: ≤ 100 CFU/g

                              Escherichia coli: Absence in 10 g’


title: Commission Implementing Regulation (EU) 2020/17 of 10 January 2020 concerning the non-renewal of the approval of the active substance chlorpyrifos-methyl, 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:
                  13.1.2020

                  EN

                  Official Journal of the European Union

                  L 7/11

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/17
         of 10 January 2020
         concerning the non-renewal of the approval of the active substance chlorpyrifos-methyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) and Article 78(2) thereof,
         Whereas:

                     (1)

                     Commission Directive 2005/72/EC (2) included chlorpyrifos-methyl 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 chlorpyrifos-methyl, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 January 2020.

                     (4)

                     Applications for the renewal of the approval of the active substance chlorpyrifos-methyl were 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 applicants submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The applications were 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 3 July 2017.

                     (7)

                     The Authority made the supplementary summary dossier available to the public. The Authority also circulated the renewal assessment report to the applicants and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

                     (8)

                     On 4 July 2018, the Authority requested that the applicants supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the form of an updated renewal assessment report.

                     (9)

                     The Authority organised an expert discussion in April 2019, to discuss certain elements related to the human health risk assessment. Due to concerns about genotoxicity and developmental neurotoxicity raised during that discussion, on 1 July 2019 the Commission sent a mandate to the Authority requesting a statement on the available outcomes of the human health assessment and an indication whether the active substance can be expected to meet the approval criteria which are applicable to human health as laid down in Article 4 of Regulation (EC) No 1107/2009.

                     (10)

                     On 31 July 2019, the Authority sent its initial statement (6) to the Commission on the available outcomes of the human health assessment. On 11 November 2019, the Authority sent its updated statement (7) to the Commission following an additional expert discussion held in September 2019. In its updated statement, the Authority confirmed its conclusions on the human health assessment that critical areas of concerns exist. A genotoxic potential of chlorpyrifos-methyl cannot be ruled out, when taking into account the concerns raised for chlorpyrifos and the available scientific open literature on chlorpyrifos-methyl in a weight of evidence approach. During the peer review, experts considered a read-across approach between the two substances justified as they are structurally similar and have similar toxicokinetic behaviour. Consequently, it is not possible to establish health-based reference values for chlorpyrifos-methyl and to conduct the relevant consumer and non-dietary risk assessments. Furthermore, concerns were identified concerning developmental neurotoxicity (DNT) for which epidemiological evidence exists, showing an association between exposure to chlorpyrifos and/or chlorpyrifos-methyl during development and adverse neurodevelopmental outcomes in children. Moreover, the peer review experts indicated that it may be appropriate to classify chlorpyrifos-methyl as toxic for reproduction, category 1B, in accordance with the criteria established under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (8).

                     (11)

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

                     (12)

                     However, despite the arguments put forward by the applicants, the concerns regarding the active substance could not be eliminated.

                     (13)

                     Consequently, it has not been established, with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. The environmental risk assessment, although not finalised, cannot alter this conclusion since the approval criteria related to the effects on human health are not satisfied and should therefore not delay further the decision-making on the renewal of the approval of the active substance. It is therefore appropriate not to renew the approval of the active substance chlorpyrifos-methyl in accordance with Article 20(1)(b) of that Regulation.

                     (14)

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

                     (15)

                     Member States should be given sufficient time to withdraw authorisations for plant protection products containing chlorpyrifos-methyl.

                     (16)

                     For plant protection products containing chlorpyrifos-methyl, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should not exceed 3 months from the date of entry into force of this Regulation.

                     (17)

                     Commission Implementing Regulation (EU) 2018/1796 (9) extended the approval period of chlorpyrifos-methyl to 31 January 2020, in order to allow the renewal process to be completed before the expiry of the approval period of that substance. However, given that a decision on the non-renewal of the approval is being taken ahead of the expiry of that extended approval period, this Regulation should apply as soon as possible.

                     (18)

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

                     (19)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Non-renewal of the approval of the active substance
            The approval of the active substance chlorpyrifos-methyl is not renewed.

            Article 2
            Amendment to Implementing Regulation (EU) No 540/2011
            In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 112, on chlorpyrifos-methyl, is deleted.

            Article 3
            Transitional measures
            Member States shall withdraw authorisations for plant protection products containing chlorpyrifos-methyl as an active substance by 16 February 2020.

            Article 4
            Grace period
            Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall expire by 16 April 2020.

            Article 5
            Entry into force
            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, 10 January 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Directive 2005/72/EC of 21 October 2005 amending Council Directive 91/414/EEC to include chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb, and metiram as active substances. (OJ L 279, 22.10.2005, p. 63).

            (3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

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

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

            (6)  EFSA (European Food Safety Authority), 2019. Statement on the available outcomes of the human health assessment in the context of the pesticides peer review of the active substance chlorpyrifos-methyl. EFSA Journal 2019;17(5):5810. https://doi.org/10.2903/j.efsa.2019.5810.

            (7)  European Food Safety Authority (EFSA), 2019. Updated statement on the available outcomes of the human health assessment in the context of the pesticides peer review of the active substance chlorpyrifos-methyl. EFSA Journal 2019;17(11):5908, 21 pp. https://doi.org/10.2903/ j.efsa.2019.5908.

            (8)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

            (9)  Commission Implementing Regulation (EU) 2018/1796 of 20 November 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances amidosulfuron, bifenox, chlorpyrifos, chlorpyrifos-methyl, clofentezine, dicamba, difenoconazole, diflubenzuron, diflufenican, dimoxystrobin, fenoxaprop-p, fenpropidin, lenacil, mancozeb, mecoprop-p, metiram, nicosulfuron, oxamyl, picloram, pyraclostrobin, pyriproxyfen and tritosulfuron (OJ L 294, 21.11.2018, p. 15).


title: Commission Implementing Regulation (EU) 2020/18 of 10 January 2020 concerning the non-renewal of the approval of the active substance chlorpyrifos, 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:
                  13.1.2020

                  EN

                  Official Journal of the European Union

                  L 7/14

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/18
         of 10 January 2020
         concerning the non-renewal of the approval of the active substance chlorpyrifos, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) and Article 78(2) thereof,
         Whereas:

                     (1)

                     Commission Directive 2005/72/EC (2) included chlorpyrifos 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 chlorpyrifos, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 January 2020.

                     (4)

                     Applications for the renewal of the approval of the active substance chlorpyrifos were 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 applicants submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The applications were 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 3 July 2017.

                     (7)

                     The Authority made the supplementary summary dossier available to the public. The Authority also circulated the renewal assessment report to the applicants and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

                     (8)

                     On 4 July 2018, the Authority requested that the applicants supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the form of an updated renewal assessment report.

                     (9)

                     The Authority organised an expert discussion in April 2019 to discuss certain elements related to the human health risk assessment. Due to concerns about genotoxicity and developmental neurotoxicity raised during that discussion, on 1 July 2019 the Commission sent a mandate to the Authority requesting a statement on the available outcomes of the human health assessment and an indication whether the active substance can be expected to meet the approval criteria which are applicable to human health as laid down in Article 4 of Regulation (EC) No 1107/2009.

                     (10)

                     On 31 July 2019, the Authority sent its statement (6) to the Commission. In its statement, the Authority confirmed that its conclusions on the human health assesment indicate that critical areas of concerns exist. Based on the information available, it cannot be excluded that chlorpyrifos has a genotoxic potential, since positive results were found in a number of in vitro and in vivo studies. Consequently, it is not possible to establish health-based reference values for chlorpyrifos and to conduct the relevant consumer and non-dietary risk assessments. Furthermore, developmental neurotoxicity (DNT) effects were observed in the available study on developmental neurotoxicity in rats and epidemiological evidence exists showing an association between exposure to chlorpyrifos and/or chlorpyrifos-methyl during development and adverse neurodevelopmental outcomes in children. Moreover, it is indicated that the peer review experts considered it appropriate to classify chlorpyrifos as toxic for reproduction, category 1B, in accordance with the criteria established under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (7).

                     (11)

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

                     (12)

                     However, despite the arguments put forward by the applicants, the concerns regarding the active substance could not be eliminated.

                     (13)

                     Consequently, it has not been established, with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. The environmental risk assessment, although not finalised, cannot alter this conclusion since the approval criteria related to the effects on human health are not satisfied and should therefore not delay further the decision-making on the renewal of the approval of the active substance. It is therefore appropriate not to renew the approval of the active substance chlorpyrifos in accordance with Article 20(1)(b) of that Regulation.

                     (14)

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

                     (15)

                     Member States should be given sufficient time to withdraw authorisations for plant protection products containing chlorpyrifos.

                     (16)

                     For plant protection products containing chlorpyrifos, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should not exceed 3 months from the date of entry into force of this Regulation.

                     (17)

                     Commission Implementing Regulation (EU) 2018/1796 (8) extended the approval period of chlorpyrifos to 31 January 2020 in order to allow the renewal process to be completed before the expiry of the approval period of that substance. However, given that a decision on the non-renewal of the approval is being taken ahead of the expiry of that extended approval period, this Regulation should apply as soon as possible.

                     (18)

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

                     (19)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Non-renewal of the approval of the active substance
            The approval of the active substance chlorpyrifos is not renewed.

            Article 2
            Amendment to Implementing Regulation (EU) No 540/2011
            In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 111, on chlorpyrifos, is deleted.

            Article 3
            Transitional measures
            Member States shall withdraw authorisations for plant protection products containing chlorpyrifos as an active substance by 16 February 2020.

            Article 4
            Grace period
            Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall expire by 16 April 2020.

            Article 5
            Entry into force
            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, 10 January 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Directive 2005/72/EC of 21 October 2005 amending Council Directive 91/414/EEC to include chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb, and metiram as active substances (OJ L 279, 22.10.2005, p. 63).

            (3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

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

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

            (6)  EFSA (European Food Safety Authority), 2019. Statement on the available outcomes of the human health assessment in the context of the pesticides peer review of the active substance chlorpyrifos. EFSA Journal 2019;17(5):5809. https://doi.org/10.2903/j.efsa.2019.5809

            (7)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

            (8)  Commission Implementing Regulation (EU) 2018/1796 of 20 November 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances amidosulfuron, bifenox, chlorpyrifos, chlorpyrifos-methyl, clofentezine, dicamba, difenoconazole, diflubenzuron, diflufenican, dimoxystrobin, fenoxaprop-p, fenpropidin, lenacil, mancozeb, mecoprop-p, metiram, nicosulfuron, oxamyl, picloram, pyraclostrobin, pyriproxyfen and tritosulfuron (OJ L 294, 21.11.2018, p. 15).