title: Commission Implementing Regulation (EU) 2019/567 of 9 April 2019 amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq

text:
                  10.4.2019

                  EN

                  Official Journal of the European Union

                  L 99/36

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/567
         of 9 April 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 the date of 22 May 2003 under that Regulation.

                     (2)

                     On 4 April 2019, the Sanctions Committee of the United Nations Security Council decided to remove nine 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, 9 April 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 Council Regulation (EC) No 1210/2003, the following entries are deleted:

                        ‘48.

                        GENERAL ESTABLISHMENT FOR THARTHAR PROJECT. Address: P.O. Box 21, Fallouja, Iraq.’

                        ‘58.

                        IRAQI BROADCASTING AND TELEVISION ESTABLISHMENT. Address: Broadcasting & TV Building, Salihiya, Karkh, Baghdad, Iraq.’

                        ‘64.

                        IRAQI NEWS AGENCY. Address: 28 Nissan Complex, Al Salihiya, Baghdad, Iraq.’

                        ‘81.

                        MINISTRY OF YOUTH, DIRECTORATE-GENERAL OF PLANNING AND FOLLOW UP, IMPORT SECTION. Address: P.O. Box 19055, Palestine Street, near Al-Shaab Stadium, Baghdad, Iraq.’

                        ‘140.

                        STATE ENTERPRISE FOR IRRIGATION PROJECTS. Address: Karantina, near Sarafiya Bridge, Baghdad, Iraq.’

                        ‘164.

                        STATE ESTABLISHMENT OF HADITHA DAM. Address: Haklanya, Haditha, Iraq.’

                        ‘165.

                        STATE ESTABLISHMENT OF HEMREEN DAM. Address: 6 Mukdadiya, Mukdadiya, Iraq.’

                        ‘169.

                        STATE ESTABLISHMENT OF MOSUL DAM. Address: Ninewa Governorate, Mosul, Iraq.’

                        ‘170.

                        STATE ESTABLISHMENT OF SMALL DAMS AND REGULATORS. Address: Sinak, Baghdad, Iraq.’


title: Commission Implementing Regulation (EU) 2019/647 of 15 April 2019 concerning the classification of certain goods in the Combined Nomenclature

text:
                  25.4.2019

                  EN

                  Official Journal of the European Union

                  L 110/13

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/647
         of 15 April 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, 15 April 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)

                        An audio apparatus (so-called ‘soundbar’) for sound reproduction of audio files of various formats from various interfaces. Its overall dimensions are approximately 110 × 14 × 7 cm.
                        The apparatus is equipped with:

                                    —

                                    Ethernet interface,

                                    —

                                    Bluetooth and WiFi network connectivity,

                                    —

                                    digital optical input and RCA line inputs and outputs,

                                    —

                                    two USB ports, of which one is mini and for product servicing.

                              The apparatus can be used with another sound reproducing apparatus or with a television apparatus. It can also reproduce audio files stored on the USB flash memory or an internet radio. It is designed to create surround sound and stereo effects.

                        8519 81 45

                        Classification is determined by general rules 1 and 6 for the interpretation of the Combined Nomenclature and by the wording of the CN codes 8519 , 8519 81  and 8519 81 45 .
                        The apparatus combines the function of a loudspeaker of heading 8518  (when used in connection with another sound reproducing apparatus or with a television apparatus) and a function of a sound reproducing apparatus of heading 8519  (when reproducing audio files from a USB flash memory or from an internet radio).
                        As the apparatus also performs a sound reproducing function, classification under heading 8518  is excluded.
                        Since the apparatus is supplied with a USB connection, it means that it is using semiconductor media. Therefore, the product is to be classified under CN code 8519 81 45  as ‘other sound reproducing apparatus using semiconductor media’.


title: Council Implementing Regulation (EU) 2019/672 of 29 April 2019 implementing Regulation (EU) No 401/2013 concerning restrictive measures in respect of Myanmar/Burma

text:
                  30.4.2019

                  EN

                  Official Journal of the European Union

                  L 114/1

         COUNCIL IMPLEMENTING REGULATION (EU) 2019/672
         of 29 April 2019
         implementing Regulation (EU) No 401/2013 concerning restrictive measures in respect of Myanmar/Burma
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to the Council Regulation (EU) No 401/2013 of 2 May 2013 concerning restrictive measures in respect of Myanmar/Burma and repealing Regulation (EC) No 194/2008 (1), and in particular Article 4i(1) thereof,
         Having regard to the proposal of the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 2 May 2013, the Council adopted Regulation (EU) No 401/2013.

                     (2)

                     In accordance with Article 4i(1) of Regulation (EU) No 401/2013, the Council has reviewed the list of designated persons and entities set out in Annex IV to that Regulation.

                     (3)

                     For two listings updated information has been received, and for all listed persons their gender should be included.

                     (4)

                     Annex IV to Regulation (EU) No 401/2013 should be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex IV to Regulation (EU) No 401/2013 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, 29 April 2019.

                  For the Council

                  The President

               G. CIAMBA

            (1)  OJ L 121, 3.5.2013, p. 1.

            ANNEX
            Entries 1 to 14 in the list of persons and entities set out in Annex IV to Regulation (EU) No 401/2013 are replaced by the following entries:

                           Name

                           Identifying information

                           Reasons

                           Date of listing

                           ‘1.

                           Aung Kyaw Zaw

                           Date of birth: 20 August 1961
                           Gender: male
                           Passport No: DM000826
                           Date of issue: 22 November 2011
                           Date of expiry: 21 November 2021
                           Military identification number: BC 17444

                           Lieutenant General Aung Kyaw Zaw was the Commander of the Bureau of Special Operations No 3 of the Myanmar Armed Forces (Tatmadaw) from August 2015 to the end of 2017. The Bureau of Special Operations No 3 oversaw the Western Command and, in that context, Lieutenant General Aung Kyaw Zaw is responsible for the atrocities and serious human rights violations committed against the Rohingya population in Rakhine State by the Western Command during that period. These include unlawful killings, sexual violence and the systematic burning of Rohingya houses and buildings.

                           25.6.2018

                           2.

                           Maung Maung Soe

                           Date of birth: March 1964
                           Gender: male
                           National Identification Number: Tatmadaw Kyee 19571

                           Major General Maung Maung Soe was the Commander of the Western Command of the Myanmar Armed Forces (Tatmadaw) from October 2016 to 10 November 2017 and oversaw the military operations in Rakhine State. In that context, he is responsible for the atrocities and serious human rights violations committed against Rohingya population in Rakhine State by the Western Command during that period. These include unlawful killings, sexual violence and systematic burning of Rohingya houses and buildings.

                           25.6.2018

                           3.

                           Than Oo

                           Date of birth: 12 October 1973
                           Gender: male
                           Military identification number: BC 25723

                           Brigadier General Than Oo is the Commander of the 99th Light Infantry Division of the Myanmar Armed Forces (Tatmadaw). In that context, he is responsible for the atrocities and serious human rights violations committed against the Rohingya population in Rakhine State in the second half of 2017 by the 99th Light Infantry Division. These include unlawful killings, sexual violence and the systematic burning of Rohingya houses and buildings.

                           25.6.2018

                           4.

                           Aung Aung

                           Gender: male
                           Military identification number: BC 23750

                           Brigadier General Aung Aung is the Commander of the 33rd Light Infantry Division of the Myanmar Armed Forces (Tatmadaw). In that context, he is responsible for the atrocities and serious human rights violations committed against the Rohingya population in Rakhine State in the second half of 2017 by the 33rd Light Infantry Division. These include unlawful killings, sexual violence and the systematic burning of Rohingya houses and buildings.

                           25.6.2018

                           5.

                           Khin Maung Soe

                           Date of birth: 1972
                           Gender: male

                           Brigadier General Khin Maung Soe is the Commander of the Military Operation Command 15, also sometimes known as the 15th Light Infantry Division, of the Myanmar Armed Forces (Tatmadaw), under which Infantry Battalion No 564 falls. In that context, he is responsible for the atrocities and serious human rights violations committed against the Rohingya population in Rakhine State in the second half of 2017 by the Military Operation Command 15, in particular by Infantry Battalion No 564. These include unlawful killings, sexual violence and the systematic burning of Rohingya houses and buildings.

                           25.6.2018

                           6.

                           Thura San Lwin

                           Date of birth: 17 March 1959
                           Gender: male

                           Brigadier General Thura San Lwin was the Commander of the Border Guard Police from October 2016 until early October 2017. In that context, he is responsible for the atrocities and serious human rights violations committed against Rohingya population in Rakhine State by the Border Guard Police during that period. These include unlawful killings and systematic burning of Rohingya houses and buildings.

                           25.6.2018

                           7.

                           Thant Zin Oo

                           Gender: male

                           Thant Zin Oo is the Commander of the 8th Security Police Battalion. In that context, he is responsible for the atrocities and serious human rights violations committed against Rohingya population in Rakhine State in the second half of 2017 by the 8th Security Police Battalion. The serious human rights violations include unlawful killings and systematic burning of Rohingya houses and buildings. Those violations were conducted in conjunction with and in direct support of the 33rd Light Infantry Division of the Myanmar Armed Forces (Tatmadaw) led by Brigadier General Aung Aung. Thant Zin Oo is therefore associated with listed person, Brigadier General Aung Aung.

                           25.6.2018

                           8.

                           Ba Kyaw

                           Gender: male

                           Ba Kyaw is a Staff Sergeant in the 564th Light Infantry Battalion (LIB) of the Myanmar Armed Forces (Tatmadaw). He committed atrocities and serious human rights violations, including murder, deportation and torture, against the Rohingya population in Rakhine State in the second half of 2017. In particular, he has been identified as one of the key perpetrators of the Maung Nu massacre on 27 August 2017.

                           21.12.2018

                           9.

                           Tun Naing

                           Gender: male

                           Tun Naing is the Commanding Officer of the Border Guard Police (BGP) base in Taung Bazar. In that capacity, he is responsible for the atrocities and serious human rights violations against the Rohingya population in Rakhine State committed by the BGP in Taung Bazar before, around and after 25 August 2017, including forced detention, ill-treatment and torture.

                           21.12.2018

                           10.

                           Khin Hlaing

                           Date of birth: 2 May 1968
                           Gender: male

                           Brigadier General Khin HLaing is the former Commander of the 99th Light Infantry Division (LID) and the current Commander of the North-eastern Command of the Myanmar Armed Forces (Tatmadaw). As the Commander of the 99th LID he oversaw military operations carried out in Shan State in 2016 and early 2017. In that context, he is responsible for the atrocities and serious human rights violations committed against ethnic minority villagers in Shan State in the second half of 2016 by the 99th LID. These include unlawful killings, forced detention and destruction of villages.

                           21.12.2018

                           11.

                           Aung Myo Thu

                           Gender: male

                           Major Aung Myo Thu is the Field Unit Commander of 33rd Light Infantry Division (LID) of the Myanmar Armed Forces (Tatmadaw). As the Field Unit Commander of the 33rd LID he oversaw military operations carried out in Rakhine State in 2017. In that context, he is responsible for the atrocities and serious human rights violations committed against the Rohingya population in Rakhine State in the second half of 2017 by the 33rd LID. These include unlawful killings, sexual violence and forced detention.

                           21.12.2018

                           12.

                           Thant Zaw Win

                           Gender: male

                           Thant Zaw Win is a Major in the 564th Light Infantry Battalion (LIB) of the Myanmar Armed Forces (Tatmadaw). In that capacity, he oversaw military operations carried out in Rakhine State and is responsible for the atrocities and serious human rights violations committed against the Rohingya population in Rakhine State by the 564th LIB, notably in and around Maung Nu village on 27 August 2017. These include unlawful killings, sexual violence and systematic burning of Rohingya houses and buildings.

                           21.12.2018

                           13.

                           Kyaw Chay

                           Gender: male

                           Kyaw Chay is a Corporal in the Border Guard Police (BGP). He was formerly based in Zay Di Pyin and was the Commanding Officer of the BGP base in Zay Di Pyin in the period around 25 August 2017 when a series of human rights violations were committed by the BGP under his command. In that context, he is responsible for the atrocities and serious human rights violations by the BGP against the Rohingya population in Rakhine State in that period. He also participated in serious human rights violations. These violations include the ill-treatment of detainees and torture.

                           21.12.2018

                           14.

                           Nyi Nyi Swe

                           Gender: male

                           Major General Nyi Nyi Swe is the former Commander of the Northern Command of the Myanmar Armed Forces (Tatmadaw). In that capacity, he is responsible for the atrocities and serious human rights violations committed in Kachin State from May 2016 to April 2018 (until his appointment as Commander of the South-western Command) by the Northern Command, including ill-treatment of civilians. He is also responsible for obstructing the provision of humanitarian assistance to civilians in need in Kachin State in that period, in particular the blocking of food transports.

                           21.12.2018’


title: Commission Implementing Regulation (EU) 2019/675 of 29 April 2019 amending Regulation (EC) No 1067/2008 opening and providing for the administration of Community tariff quotas for common wheat of a quality other than high quality from third countries

text:
                  30.4.2019

                  EN

                  Official Journal of the European Union

                  L 114/10

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/675
         of 29 April 2019
         amending Regulation (EC) No 1067/2008 opening and providing for the administration of Community tariff quotas for common wheat of a quality other than high quality from third countries
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular point (a) of the first paragraph of Article 187 thereof,
         Whereas:

                     (1)

                     Article 2(1) of Commission Regulation (EC) No 1067/2008 (2) provides for the opening of an overall tariff quota for the import of 3 073 177 tonnes of common wheat falling under CN code 1001 99 00 of a quality other than high quality, at a duty rate of EUR 12 per tonne.

                     (2)

                     Within the overall tariff quota, Article 3(1) of Regulation (EC) No 1067/2008 provides for a subquota of 2 378 387 tonnes for third countries, except Canada and the United States of America, as well as for a subquota erga omnes of 122 790 tonnes.

                     (3)

                     In the context of the Agreement with the United States in the framework of Article XXIV:6 GATT pursuant the European Union enlargement of 2004 (3), it was however agreed to take into account, within the subquota erga omnes, a volume of 6 787 tonnes. Therefore, 6 787 tonnes are to be added to the subquota erga omnes while the same quantity is to be deducted from the subquota for third countries, except Canada and the United States of America.

                     (4)

                     On the basis of Article 3(3) of Regulation (EC) No 1067/2008, the subquota for third countries, except Canada and the United States of America, is to be divided into four quarterly subperiods. Taking into account the abovementioned reduction of the quantity for that subquota, it is needed to adapt the volume of each quarterly subperiod.

                     (5)

                     Regulation (EC) No 1067/2008 should therefore be amended accordingly.

                     (6)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Article 3 of Regulation (EC) No 1067/2008 is amended as follows:

                        (1)

                        paragraph 1 is replaced by the following:

                           ‘1.   The import tariff quota referred to in Article 2(1) shall be divided into three subquotas:

                                       (a)

                                       subquota I (order number 09.4123): 572 000 tonnes for the United States of America;

                                       (b)

                                       subquota II (order number 09.4125): 2 371 600 tonnes for third countries, except Canada and the United States of America;

                                       (c)

                                       subquota III (order number 09.4133): 129 577 tonnes for erga omnes.’;

                        (2)

                        paragraph 3 is replaced by the following:

                           ‘3.   Subquota II shall be divided into four quarterly subperiods, covering the following dates and quantities:

                                       (a)

                                       subperiod 1: 1 January to 31 March: 592 900 tonnes;

                                       (b)

                                       subperiod 2: 1 April to 30 June: 592 900 tonnes;

                                       (c)

                                       subperiod 3: 1 July to 30 September: 592 900 tonnes;

                                       (d)

                                       subperiod 4: 1 October to 31 December: 592 900 tonnes.’

            Article 2
            This Regulation shall enter into force on the seventh 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, 29 April 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Regulation (EC) No 1067/2008 of 30 October 2008 opening and providing for the administration of Community tariff quotas for common wheat of a quality other than high quality from third countries and derogating from Council Regulation (EC) No 1234/2007 (OJ L 290, 31.10.2008, p. 3).

            (3)  Council Decision 2006/333/EC of 20 March 2006 on the conclusion of an Agreement in the form of an Exchange of Letters between the European Community and the United States of America pursuant to Article XXIV:6 and Article XXVIII of the General Agreement on Tariffs and Trade (GATT) 1994 relating to the modification of concessions in the schedules of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic in the course of their accession to the European Union (OJ L 124, 11.5.2006, p. 13).


title: Commission Implementing Regulation (EU) 2019/676 of 29 April 2019 approving the low-risk active substance ABE-IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623), 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:
                  30.4.2019

                  EN

                  Official Journal of the European Union

                  L 114/12

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/676
         of 29 April 2019
         approving the low-risk active substance ABE-IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623), in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 22(1) in conjunction with Article 13(2) thereof,
         Whereas:

                     (1)

                     In accordance with Article 7(1) of Regulation (EC) No 1107/2009, the Task Force ABE-IT 56 submitted to France on 1 April 2016 an application for the approval of the active substance ABE-IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) (hereinafter ‘ABE-IT 56’).

                     (2)

                     In accordance with Article 9(3) of Regulation (EC) No 1107/2009, France, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) of the admissibility of the application on 25 May 2016.

                     (3)

                     On 20 June 2017, the rapporteur Member State submitted a draft assessment report to the Commission, with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

                     (4)

                     The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of that Regulation, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report in May 2018.

                     (5)

                     On 26 July 2018, the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance ABE-IT 56 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 (2). The Authority made its conclusion available to the public.

                     (6)

                     On 23 October 2018 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for ABE-IT 56 and on 22 March 2019 a draft Regulation providing that ABE-IT 56 is approved.

                     (7)

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

                     (8)

                     It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to approve ABE-IT 56.

                     (9)

                     The Commission further considers that ABE-IT 56 is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. ABE-IT 56 is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009. ABE-IT 56 is a fractionation product of the lysate of Saccharomyces cerevisiae strain DDSF623. Saccharomyces cerevisiae is the most widely used yeast in industrial/commercial food and beverage production and is ubiquitous in the environment. It is not pathogenic to humans or animals, nor is it infective to humans. It is in general naturally occurring and does not constitute a distinct risk to any compartment of the environment.

                     (10)

                     It is therefore appropriate to approve ABE-IT 56 as a low risk substance for a period of 15 years.

                     (11)

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

                     (12)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Approval of active substance
            The active substance ABE-IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623), as specified in Annex I, is approved subject to the conditions laid down in that Annex.

            Article 2
            Amendments to Implementing Regulation (EU) No 540/2011
            The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 29 April 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Conclusion on the peer review of the pesticide risk assessment of the active substance ABE-IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623). EFSA Journal 2018;16(9):5400, 14 pp. https://doi.org/10.2903/j.efsa.2018.5400.

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

            ANNEX I

                        Common Name, Identification Numbers

                        IUPAC Name

                        Purity (1)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                        ABE-IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

                        Not applicable

                        1 000  g/kg (active substance)

                        20 May 2019

                        20 May 2034

                        For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ABE-IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) and in particular Appendices I and II thereof, shall be taken into account.

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

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

                           Number

                           Common Name, Identification Numbers

                           IUPAC Name

                           Purity (1)

                           Date of approval

                           Expiration of approval

                           Specific provisions

                           ‘16

                           ABE-IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

                           Not Applicable

                           1 000  g/kg (active substance)

                           20 May 2019

                           20 May 2034

                           For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ABE-IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) and in particular Appendices I and II thereof, shall be taken into account.’

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


title: Commission Implementing Regulation (EU) 2019/677 of 29 April 2019 concerning the non-renewal of the approval of the active substance chlorothalonil, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance.)

text:
                  30.4.2019

                  EN

                  Official Journal of the European Union

                  L 114/15

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/677
         of 29 April 2019
         concerning the non-renewal of the approval of the active substance chlorothalonil, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) and Article 78(2) thereof,
         Whereas:

                     (1)

                     Commission Directive 2005/53/EC (2) included chlorothalonil 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 chlorothalonil, 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 chlorothalonil 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 applicants 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 2 September 2016.

                     (7)

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

                     (8)

                     On 6 December 2017 the Authority communicated to the Commission its conclusion (6) on whether chlorothalonil can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

                     (9)

                     A critical concern was identified by the Authority in relation to the contamination of groundwater by metabolites of chlorothalonil. In particular, metabolites R417888, R419492, R471811, SYN507900, M3, M11, M2, M7 and M10 are predicted to occur above the parametric value of 0,1 μg/L in all pertinent scenarios for all proposed uses of chlorothalonil. Therefore, it cannot currently be established that the presence of metabolites of chlorothalonil in groundwater will not result in unacceptable effects on groundwater and in harmful effects on human health as required by Article 4(3)(b) of Regulation (EC) No 1107/2009. Furthermore, the Authority could not exclude a genotoxicity concern for residues to which consumers will be exposed and identified a high risk to amphibians and fish for all the uses evaluated.

                     (10)

                     Furthermore, several areas of the risk assessment could not be finalised due to insufficient data in the dossier. In particular, the assessment of consumer risk from dietary exposure could not be completed because of lack of data to confirm the definition of the residue in plants and the livestock exposure assessment, including the toxicological assessment of a metabolite.

                     (11)

                     Additionally, chlorothalonil is classified as carcinogen category 2 in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (7) while in the conclusion of the Authority it is indicated that chlorothalonil should be classified as carcinogen category 1B. For the representative uses considered, residue levels as referred to in point (b) of Article 18(1) of Regulation (EC) No 396/2005 could not be confirmed for plant and animal products due to lack of data on the magnitude and toxicity of metabolites that are included in the residue definition for risk assessment. Consequently, the requirement set out in Point 3.6.3 of Annex II to Regulation (EC) No 1107/2009 is not fulfilled.

                     (12)

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

                     (13)

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

                     (14)

                     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. It is therefore appropriate not to renew the approval of the active substance chlorothalonil in accordance with Article 20(1)(b) of that Regulation.

                     (15)

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

                     (16)

                     Member States should be allowed sufficient time to withdraw authorisations for plant protection products containing chlorothalonil.

                     (17)

                     For plant protection products containing chlorothalonil, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 20 May 2020.

                     (18)

                     Commission Implementing Regulation (EU) 2018/1262 (8) extended the approval period of chlorothalonil to 31 October 2019 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision on the non-renewal of the approval is taken ahead of that extended expiry date, this Regulation should apply as soon as possible.

                     (19)

                     This Regulation does not prevent the submission of a further application for the approval of chlorothalonil in accordance with Article 7 of Regulation (EC) No 1107/2009.

                     (20)

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

               HAS ADOPTED THIS REGULATION:

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

            Article 2
            Amendments to Implementing Regulation (EU) No 540/2011
            In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 101, on chlorothalonil, is deleted.

            Article 3
            Transitional measures
            Member States shall withdraw authorisations for plant protection products containing chlorothalonil as active substance by 20 November 2019 at the latest.

            Article 4
            Grace period
            Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire by 20 May 2020 at the latest.

            Article 5
            Entry into force
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 29 April 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Directive 2005/53/EC of 16 September 2005 amending Council Directive 91/414/EEC to include chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl as active substances (OJ L 241, 17.9.2005, p. 51).

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

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

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

            (6)  EFSA (European Food Safety Authority), 2016. Conclusion on the peer review of the pesticide risk assessment of the active substance chlorothalonil. EFSA Journal2018;16(1):5126, 40 pp.; https://doi.org/10.2903/j.efsa.2018.5126.

            (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) 2018/1262 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).