title: Commission Implementing Regulation (EU) 2018/949 of 3 July 2018 amending Regulation (EC) No 1235/2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries (Text with EEA relevance.)

text:
               4.7.2018

               EN

               Official Journal of the European Union

               L 167/3

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/949
   of 3 July 2018
   amending Regulation (EC) No 1235/2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (1), and in particular Article 33(2) and (3) and Article 38(d) thereof,
   Whereas:

               (1)

               Annex III to Commission Regulation (EC) No 1235/2008 (2) sets out the list of third countries whose systems of production and control measures for organic production of agricultural products are recognised as equivalent to those laid down in Regulation (EC) No 834/2007.

               (2)

               In accordance with the Agreement between the European Union and the Republic of Chile on trade in organic products, approved by Council Decision (EU) 2017/2307 (3), the Union and Chile accept the import into their territory, and the placing on the market as organic products, of the products listed in an Annex to that Agreement, provided that those products comply with each other's laws and regulations. Annex I to that Agreement covers organic products from Chile for which the Union recognises equivalence. For the sake of clarity, Chile should be included in the list in Annex III to Regulation (EC) No 1235/2008.

               (3)

               According to information provided by Costa Rica, its competent authority has added one new control body, namely ‘Primus Auditing Operations de Costa Rica S.A’ to the list of control bodies recognised by Costa Rica.

               (4)

               According to information provided by Switzerland, the names of the control bodies ‘Institut für Marktökologie (IMO)’ and ‘ProCert Safety AG’ have been changed to ‘IMOswiss AG’ and ‘ProCert AG’ respectively.

               (5)

               According to information provided by Tunisia, the name of its competent authority has changed. In addition, Tunisia has informed the Commission that its competent authority has added one control body, namely ‘CERES GmbH’, to the list of control bodies recognised by Tunisia and that the name of the control body ‘Ecocert SA en Tunisie’ has changed to ‘Ecocert SA’. The recognition of the control body ‘Suolo e Salute’ has been withdrawn. Finally, the control bodies ‘Kiwa BCS Öko-Garantie GmbH’ and ‘Institut national de la normalisation et de la propriété industrielle (INNORPI)’ have been assigned new code numbers.

               (6)

               According to information provided by South Korea, new internet addresses have been provided for ‘OCK’ and ‘Neo environmentally-friendly’. The recognition of the control body ‘Ecocert’ has been withdrawn. Finally, the South Korean competent authority has recognised four more control bodies which should be added to the list in Annex III to Regulation (EC) No 1235/2008: ‘Ecolivestock Association’, ‘Association for Agricultural Products Quality Evaluation’, ‘University Industry Liaison office of CNU’ and ‘Eco Agriculture Institute Inc.’

               (7)

               Annex IV to Regulation (EC) No 1235/2008 sets out the list of control authorities and control bodies competent to carry out controls and issue certificates in third countries for the purpose of equivalence.

               (8)

               The Commission has received and examined a request from ‘Agreco R.F. Göderz GmbH’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to recognise ‘Agreco R.F. Göderz GmbH’ for product category B in respect of all the third countries for which it had been recognised for other product categories and to extend the geographical scope of its recognition for product category D to Cape Verde, Fiji, Iran, Cambodia, the former Yugoslav Republic of Macedonia, Solomon Islands, El Salvador, Tonga and Samoa, and for product category A in respect of Mexico and Uruguay.

               (9)

               The Commission has received and examined a request from ‘Bioagricert S.r.l’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to recognise ‘Bioagricert S.r.l’ for product category D in respect of Indonesia.

               (10)

               The Commission has received and examined a request from ‘Biocert International Pvt Ltd’ to be included in the list in Annex IV to Regulation (EC) No 1235/2008. Based on the information received, the Commission has concluded that it is justified to recognise ‘Biocert International Pvt Ltd’ for product categories D and E in respect of India and for product categories A and D in respect of Sri Lanka.

               (11)

               The Commission has received and examined a request from ‘Ecocert SA’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the geographical scope of its recognition for product categories A and D to New Caledonia, for product category B to Armenia and for product category E to Togo.

               (12)

               ‘Ecoglobe’ has notified the Commission of the change of its address and internet address.

               (13)

               The Commission has received and examined a request from ‘Ekoagros’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the recognition for Russia to product categories B and D.

               (14)

               ‘NASAA Certified Organic Pty Ltd’ has notified the Commission of the change of its internet address.

               (15)

               The Commission has received and examined a request from ‘OneCert International PVT Ltd’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the geographical scope of its recognition for product categories A and D to Benin, Indonesia, Nigeria, the Philippines and Togo.

               (16)

               ‘Organic Certifiers’ has informed the Commission that it has ceased its certification activities in all third countries for which it was recognised. It should therefore no longer be listed in Annex IV to Regulation (EC) No 1235/2008.

               (17)

               ‘ORSER’ has notified the Commission of the change of its address.

               (18)

               The Commission has received and examined a request from ‘Q-check’ to be included in the list in Annex IV to Regulation (EC) No 1235/2008. Based on the information received, the Commission has concluded that it is justified to recognise ‘Q-check’ for product categories A and D in respect of Albania, Egypt, Jordan, Kosovo, Lebanon, Peru, Saudi Arabia, Serbia, Turkey and the United Arab Emirates.

               (19)

               ‘Quality Partner’ has informed the Commission that it has ceased its certification activities in Indonesia, the only third country for which it was recognised. It should therefore no longer be listed in Annex IV to Regulation (EC) No 1235/2008.

               (20)

               ‘Soil Association Certification Limited’ has informed the Commission that it will cease its certification activities in Egypt and Iran. As a consequence, those countries should no longer be listed in Annex IV to Regulation (EC) No 1235/2008.

               (21)

               The Commission has received and examined a request from ‘Valsts SIA “Sertifikācijas un testēšanas centrs”’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the geographical scope of its recognition for product category A to Belarus and for product categories A and B to Uzbekistan.

               (22)

               As a consequence of the inclusion of Chile in Annex III to Regulation (EC) No 1235/2008, the relevant control bodies recognised until now for the import of products from categories A, D or F from Chile should continue to be recognised in respect of Chile for those product categories, except for the products falling within the scope of the trade agreement.

               (23)

               Annexes III and IV to Regulation (EC) No 1235/2008 should therefore be amended accordingly.

               (24)

               The measures provided for in this Regulation are in accordance with the opinion of the Committee on organic production,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Regulation (EC) No 1235/2008 is amended as follows:

               (1)

               Annex III is amended in accordance with Annex I to this Regulation;

               (2)

               Annex IV is amended in accordance with Annex II to this Regulation.

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

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 3 July 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 189, 20.7.2007, p. 1.

      (2)  Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries (OJ L 334, 12.12.2008, p. 25).

      (3)  Council Decision (EU) 2017/2307 of 9 October 2017 on the conclusion of the Agreement between the European Union and the Republic of Chile on trade in organic products (OJ L 331, 14.12.2017, p. 1).

      ANNEX I
      Annex III to Regulation (EC) No 1235/2008 is amended as follows:

                  (1)

                  after the entry relating to Canada, the following new entry is inserted:
                  ‘CHILE

                              1.

                              Product categories:

                                          Category of products or products

                                          Designation of category as in Annex IV

                                          Limitations

                                          Unprocessed plant products

                                          A

                                          Only products listed in the Agreement

                                          Honey

                                          Only products listed in the Agreement

                                          Processed plant products for use as food

                                          D

                                          Only products listed in the Agreement

                                          Vegetative propagating material and seeds for cultivation

                                          F

                                          Only products listed in the Agreement

                              2.

                              Origin: organically grown ingredients in products of categories A and D that have been grown in Chile or that have been imported into Chile:

                                          —

                                          either from the Union,

                                          —

                                          or from a third country in the framework of a regime that is recognised as equivalent by the Union in accordance with Article 33(2) of Regulation (EC) No 834/2007.

                              3.

                              Production standards: Law 20.089, of 17 January 2006, that creates a national certification system for agricultural organic products.

                              4.

                              Competent authority: Servicio Agricola y Ganadero (SAG), Ministry of Agriculture. http://www.sag.cl/ambitos-de-accion/certificacion-de-productos-organicos

                              5.

                              Control bodies:

                                          Code number

                                          Name

                                          Internet address

                                          CL-BIO-001

                                          Ecocert Chile S.A.

                                          www.ecocert.cl

                                          CL-BIO-004

                                          ARGENCERT (Instituto Argentino para la Certificación y Promoción de productos)

                                          www.argencert.com.ar

                                          CL-BIO-005

                                          CERES — Certification of Environmental Standards GmbH

                                          http://www.ceres-cert.com/

                                          CL-BIO-010

                                          BIO CERTIFICADORA SERVICIOS LIMITADA

                                          www.bioaudita.cl

                              6.

                              Certificate issuing bodies and authorities: as at point 5.

                              7.

                              Duration of the inclusion: until 31 December 2020.’

                  (2)

                  in the entry relating to Costa Rica, in point 5, the following row relating to code number CR-BIO-007 is added:

                              ‘CR-BIO-007

                              Primus Auditing Operations de Costa Rica S.A

                              www.primusauditingops.com’

                  (3)

                  in the entry relating to Switzerland, in point 5, the rows relating to code numbers CH-BIO-004 and CH-BIO-038 are replaced by the following:

                              ‘CH-BIO-004

                              IMOswiss AG

                              www.imo.ch

                              CH-BIO-038

                              ProCert AG

                              https://www.procert.ch/’

                  (4)

                  in the entry relating to Tunisia, points 4 and 5 are replaced by the following:

                              ‘4.

                              Competent authority: Ministère de l'Agriculture, des Ressources Hydrauliques et de la Pêche, www.agriculture.tn and www.onagri.tn.

                              5.

                              Control bodies:

                                          TN-BIO-001

                                          Ecocert SA

                                          www.ecocert.com

                                          TN-BIO-007

                                          Institut national de la normalisation et de la propriété industrielle (INNORPI)

                                          www.innorpi.tn

                                          TN-BIO-008

                                          CCPB Srl

                                          www.ccpb.it

                                          TN-BIO-009

                                          CERES GmbH

                                          www.ceres-cert.com

                                          TN-BIO-010

                                          Kiwa BCS Öko-Garantie GmbH

                                          www.kiwabcs.com’

                  (5)

                  in the entry relating to Republic of Korea, point 5 is amended as follows:

                              (a)

                              the rows relating to KR-ORG-005, KR-ORG-019 are replaced by the following:

                                          ‘KR-ORG-005

                                          OCK

                                          http://www.greenock.co.kr/

                                          KR-ORG-019

                                          Neo environmentally-friendly

                                          http://neoefcc.modoo.at’

                              (b)

                              KR-ORG-016 is deleted;

                              (c)

                              the following rows are added:

                                          ‘KR-ORG-025

                                          Ecolivestock Association

                                          http://www.ecolives.co.kr

                                          KR-ORG-026

                                          Association for Agricultural Products Quality Evaluation

                                          http://apqe.co.kr

                                          KR-ORG-027

                                          University Industry Liaison office of CNU

                                          http://sanhak.jnu.ac.kr/eng/

                                          KR-ORG-029

                                          Eco Agriculture Institute Inc.

                                          http://blog.daum.net/ifea2011’

      ANNEX II
      Annex IV to Regulation (EC) No 1235/2008 is amended as follows:

                  (1)

                  in the entry relating to ‘A CERT European Organization for Certification S.A.’, point 4 is replaced by the following:

                              ‘4.

                              Exceptions: in-conversion products and products covered by Annex III.’;

                  (2)

                  in the entry relating to ‘Agreco R.F. Göderz GmbH’, point 3 is amended as follows:

                              (a)

                              in the rows concerning Mexico and Uruguay, a cross is added in column A;

                              (b)

                              in the rows concerning Azerbaijan, Bosnia and Herzegovina, Burkina Faso, Bolivia, Cameroon, Colombia, Cuba, Cape Verde, Dominican Republic, Ecuador, Egypt, Ethiopia, Fiji, Georgia, Ghana, Guatemala, Honduras, Indonesia, Iran, Kenya, Kyrgyzstan, Cambodia, Kazakhstan, Sri Lanka, Morocco, Moldova, Montenegro, Madagascar, the former Yugoslav Republic of Macedonia, Mali, Mexico, Nigeria, Nicaragua, Nepal, Peru, Papua New Guinea, Philippines, Paraguay, Serbia, Russia, Solomon Islands, Senegal, Suriname, El Salvador, Togo, Thailand, Turkmenistan, Tonga, Tuvalu, Tanzania, Ukraine, Uganda, Uruguay, Uzbekistan, Venezuela, Vietnam, Samoa and South Africa, a cross is added in column B;

                              (c)

                              in the rows concerning Cape Verde, Fiji, Iran, Cambodia, the former Yugoslav Republic of Macedonia, Solomon Islands, El Salvador, Tonga and Samoa a cross is added in column D;

                  (3)

                  in the entry relating to ‘Bioagricert S.r.l’, in point 3, in the row concerning Indonesia, a cross is added in column D;

                  (4)

                  after the entry relating to ‘BIOcert Indonesia’, the following new entry is inserted:
                  ‘“Biocert International Pvt Ltd”

                              1.

                              Address: 701 Pukhraj Corporate, Opposite Navlakha Bus Stop, Indore, 452001, India

                              2.

                              Internet address: http://www.biocertinternational.com

                              3.

                              Code numbers, third countries and product categories concerned:

                                          Code number

                                          Third country

                                          Category of products

                                          A

                                          B

                                          C

                                          D

                                          E

                                          F

                                          IN-BIO-177

                                          India

                                          —

                                          —

                                          —

                                          x

                                          x

                                          —

                                          LK-BIO-177

                                          Sri Lanka

                                          x

                                          —

                                          —

                                          x

                                          —

                                          —

                              4.

                              Exceptions: in-conversion products

                              5.

                              Duration of inclusion: until 30 June 2021’;

                  (5)

                  in the entry relating to ‘CERES Certification of Environmental Standards GmbH’, point 4 is replaced by the following:

                              ‘4.

                              Exceptions: in-conversion products and products covered by Annex III.’;

                  (6)

                  in the entry relating to ‘Ecocert SA’, point 3 is amended as follows:

                              (a)

                              the following row is inserted in the order of the code numbers:

                                          ‘NC-BIO-154

                                          New Caledonia

                                          x

                                          —

                                          —

                                          x

                                          —

                                          —’

                              (b)

                              in the row concerning Armenia, a cross is added in column B;

                              (c)

                              in the row concerning Togo, a cross is added in column E;

                  (7)

                  in the entry relating to ‘Ecoglobe’, points 1 and 2 are replaced by the following:

                              ‘1.

                              Address: 80 Aram Street, 0002 Yerevan, Armenia

                              2.

                              Internet address: http://www.ecoglobe.com’;

                  (8)

                  in the entry relating to ‘Ekoagros’, in point 3, in the row relating to Russia, a cross is added in columns B and D;

                  (9)

                  in the entry relating to ‘IMOcert Latinoamérica Ltda’, point 4 is replaced by the following:

                              ‘4.

                              Exceptions: in-conversion products and products covered by Annex III.’;

                  (10)

                  in the entry relating to ‘LACON GmbH’, point 4 is replaced by the following:

                              ‘4.

                              Exceptions: in-conversion products and products covered by Annex III.’;

                  (11)

                  in the entry relating to ‘NASAA Certified Organic Pty Ltd’, point 2 is replaced by the following:

                              ‘2.

                              Internet address: www.nasaacertifiedorganic.com.au’;

                  (12)

                  in the entry relating to ‘OneCert International PVT Ltd’, in point 3, the following rows are inserted in the order of the code numbers:

                              ‘BJ-BIO-152

                              Benin

                              x

                              —

                              —

                              x

                              —

                              —

                              ID-BIO-152

                              Indonesia

                              x

                              —

                              —

                              x

                              —

                              —

                              NG-BIO-152

                              Nigeria

                              x

                              —

                              —

                              x

                              —

                              —

                              PH-BIO-152

                              Philippines

                              x

                              —

                              —

                              x

                              —

                              —

                              TG-BIO-152

                              Togo

                              x

                              —

                              —

                              x

                              —

                              —’

                  (13)

                  in the entry relating to ‘Oregon Tilth’, point 4 is replaced by the following:

                              ‘4.

                              Exceptions: in-conversion products and products covered by Annex III.’;

                  (14)

                  the entry relating to the ‘Organic Certifiers’ is deleted;

                  (15)

                  in the entry relating to ‘ORSER’, point 1 is replaced by the following:

                              ‘1.

                              Address: Prof. Dr Ahmet Taner Kislali Mah.2842 Sok.No: 4, 06810 Cayyolu, Cankaya-Ankara-TURKEY’;

                  (16)

                  after the entry relating to ‘Overseas Merchandising Inspection Co., Ltd’, the following new entry is inserted:
                  ‘“Q-check”

                              1.

                              Address: 9-17 Erithrou Stavrou str., Larissa, Greece

                              2.

                              Internet address: http://www.qcheck-cert.gr

                              3.

                              Code numbers, third countries and product categories concerned:

                                          Code number

                                          Third country

                                          Category of products

                                          A

                                          B

                                          C

                                          D

                                          E

                                          F

                                          AL-BIO-179

                                          Albania

                                          x

                                          —

                                          —

                                          x

                                          —

                                          —

                                          AE-BIO-179

                                          United Arab Emirates

                                          x

                                          —

                                          —

                                          x

                                          —

                                          —

                                          EG-BIO-179

                                          Egypt

                                          x

                                          —

                                          —

                                          x

                                          —

                                          —

                                          JO-BIO-179

                                          Jordan

                                          x

                                          —

                                          —

                                          x

                                          —

                                          —

                                          RKS-BIO-179

                                          Kosovo

                                          x

                                          —

                                          —

                                          x

                                          —

                                          —

                                          LB-BIO-179

                                          Lebanon

                                          x

                                          —

                                          —

                                          x

                                          —

                                          —

                                          PE-BIO-179

                                          Peru

                                          x

                                          —

                                          —

                                          x

                                          —

                                          —

                                          TR-BIO-179

                                          Turkey

                                          x

                                          —

                                          —

                                          x

                                          —

                                          —

                                          SA-BIO-179

                                          Saudi Arabia

                                          x

                                          —

                                          —

                                          x

                                          —

                                          —

                                          RS-BIO-179

                                          Serbia

                                          x

                                          —

                                          —

                                          x

                                          —

                                          —

                              4.

                              Exceptions: in-conversion products

                              5.

                              Duration of inclusion: until 30 June 2021’;

                  (17)

                  the entry relating to ‘Quality Partner’ is deleted;

                  (18)

                  in the entry relating to ‘Soil Association Certification Limited’, in point 3, the rows relating to Egypt and Iran are deleted;

                  (19)

                  in the entry relating to ‘Valsts SIA“Sertifikācijas un testēšanas centrs”’, in point 3, the following rows are inserted in the order of the code numbers:

                              ‘BY-BIO-173

                              Belarus

                              x

                              —

                              —

                              —

                              —

                              —

                              UZ-BIO-173

                              Uzbekistan

                              x

                              x

                              —

                              —

                              —

                              —’


title: Commission Implementing Regulation (EU) 2018/1121 of 10 August 2018 amending Commission Implementing Regulation (EU) 2015/1518 imposing a definitive anti-dumping duty on imports of biodiesel originating in the United States of America following an expiry review pursuant to Article 11(2) of Council Regulation (EC) No 1225/2009

text:
                  13.8.2018

                  EN

                  Official Journal of the European Union

                  L 204/33

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1121
         of 10 August 2018
         amending Commission Implementing Regulation (EU) 2015/1518 imposing a definitive anti-dumping duty on imports of biodiesel originating in the United States of America following an expiry review pursuant to Article 11(2) of Council Regulation (EC) No 1225/2009
         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),
         Having regard to Commission Implementing Regulation (EU) 2015/1518 of 14 September 2015 imposing a definitive anti-dumping duty on imports of biodiesel originating in the United States of America following an expiry review pursuant to Article 11(2) of Council Regulation (EC) No 1225/2009 (2), and in particular Article 1(6) thereof,
         Whereas:
         A.   MEASURES IN FORCE

                     (1)

                     By Council Regulation (EC) No 599/2009 of 7 July 2009 (3), the Council imposed a definitive anti-dumping duty on imports of biodiesel originating in the United States of America (‘USA’).

                     (2)

                     In the original investigation, a large number of exporting producers from the USA made themselves known. As a result, the Commission selected a sample of American exporting producers to be investigated.

                     (3)

                     The Council imposed individual duty rates on imports of biodiesel originating in the USA ranging from EUR 0 to 198 per tonne net on the sampled companies, and a weighted average duty of EUR 115,6 per tonne net on other cooperating companies not included in the sample. In addition, a duty rate of EUR 172,2 per tonne net was imposed on imports of biodiesel from all other American companies.

                     (4)

                     Following an expiry review based on Article 11(2) of Regulation (EC) No 1225/2009, the original measures were prolonged for five years by Implementing Regulation (EU) 2015/1518.

                     (5)

                     Commission Implementing Regulation (EU) 2017/1598 (4) amended Implementing Regulation (EU) 2015/1518 to include Article 1(6) allowing exporting producers to request a new exporting producer treatment.

                     (6)

                     Article 1(6) of Implementing Regulation (EU) 2015/1518 states that the Commission may amend Annex I, in order to attribute the duty applicable to cooperating producers not included in the sample, namely EUR 115,6 per tonne net, where any party from the USA provides sufficient evidence to the Commission that:

                                 (a)

                                 it did not export biodiesel originating in the USA during the period of investigation (1 April 2007-31 March 2008);

                                 (b)

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

                                 (c)

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

               B.   REQUESTS FOR NEW EXPORTING PRODUCER TREATMENT

                     (7)

                     Following the publication of Implementing Regulation (EU) 2015/1518, an American company, Organic Technologies (‘the applicant’), came forward claiming that it met all three criteria set out in recital 6 and should be granted new exporting producer treatment. The applicant provided information and supporting evidence in response to a questionnaire from the Commission. After an initial analysis of the questionnaire response, the Commission sent the applicant a letter requesting further information. The applicant responded.

                     (8)

                     As for criterion (a), the applicant claimed that it existed during the original investigation period. It also claimed that it started to produce biodiesel in 2009, that is, after the original investigation period. The Commission verified the sales ledgers provided by the applicant. The applicant showed that it started production of biodiesel in 2009 and the first sales outside of the USA took place only in 2016. Therefore, the Commission accepted that the applicant did not export biodiesel to the Union during the original investigation period. Hence, the applicant complies with criterion (a).

                     (9)

                     With regard to the criterion (b), namely that the applicant is not related to an exporter or producer subject to anti-dumping measures imposed by Implementing Regulation (EU) 2015/1518, the Commission established, on the basis of the documents submitted by the applicant, that the applicant does not have any related companies which are subject to the measures. Therefore, the applicant complies with criterion (b).

                     (10)

                     With regard to the criterion (c), the Commission also established that the applicant had entered into an irrevocable contractual obligation to export a significant quantity of the product concerned to the Union in 2018. In that respect, the applicant provided a sales contract for the delivery of the product concerned in 2018, which satisfied this criterion. Therefore, the applicant complies with criterion (c).

                     (11)

                     Consequently, 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 I to Implementing Regulation (EU) 2015/1518.

                     (12)

                     Therefore, Commission Implementing Regulation (EU) 2015/1518 should be amended accordingly.

                     (13)

                     The Commission informed the applicant and the Union industry of these findings and gave an opportunity to comment. The Commission received no comments.

                     (14)

                     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
            In Annex I to Commission Implementing Regulation (EU) 2015/1518 the following company shall be added to the list of exporting producers from the United States of America:

                           Company name

                           City

                           TARIC additional code

                           ‘Organic Technologies

                           Coshocton (Ohio)

                           C482 ’

            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 August 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Implementing Regulation (EU) 2015/1518 of 14 September 2015 imposing a definitive anti-dumping duty on imports of biodiesel originating in the United States of America following an expiry review pursuant to Article 11(2) of Council Regulation (EC) No 1225/2009 (OJ L 239, 15.9.2015, p. 69).

            (3)  Council Regulation (EC) No 599/2009 of 7 July 2009 imposing a definitive anti-dumping duty and collecting definitively the provisional duty imposed on imports of biodiesel originating in the United States of America (OJ L 179, 10.7.2009, p. 26).

            (4)  Commission Implementing Regulation (EU) 2017/1598 of 22 September 2017 amending Commission Implementing Regulation (EU) 2015/1518 imposing a definitive anti-dumping duty on imports of biodiesel originating in the United States of America following an expiry review pursuant to Article 11(2) of Council Regulation (EC) No 1225/2009 (OJ L 245, 23.9.2017, p. 1)


title: Commission Implementing Regulation (EU) 2018/1122 of 10 August 2018 authorising the placing on the market of pyrroloquinoline quinone disodium salt 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:
                  13.8.2018

                  EN

                  Official Journal of the European Union

                  L 204/36

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1122
         of 10 August 2018
         authorising the placing on the market of pyrroloquinoline quinone disodium salt 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 the Commission Implementing Regulation (EU) 2017/2470 (2) was adopted, which establishes a Union list of authorised novel foods.

                     (3)

                     Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on updating the Union list.

                     (4)

                     On 6 December 2012, the company Mitsubishi Gas Chemical Company, Inc. (‘the Applicant’) made a request to the competent authority of Ireland to place pyrroloquinoline quinone disodium salt produced from the bacterium Hyphomicrobium denitrificans, on the Union market as a novel food ingredient within the meaning of point (c) of Article 1(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council (3). The application requests for pyrroloquinoline quinone disodium salt to be used in food supplements for the general adult population, excluding pregnant and lactating women.

                     (5)

                     Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 concerning novel foods and novel food ingredients, and for which the final decision has not been taken before 1 January 2018 shall be treated as an application submitted under Regulation (EU) 2015/2283.

                     (6)

                     While the request for placing pyrroloquinoline quinone disodium salt on the market as a novel food within the Union was submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, the application also meets the requirements laid down in Regulation (EU) 2015/2283.

                     (7)

                     On 8 July 2016, the competent authority of Ireland issued its initial assessment report. In that report, it came to the conclusion that an additional assessment is required for pyrroloquinoline quinone disodium salt with regards to its safety following long-term consumption at the levels proposed in the application, in accordance with Article 6(3) of Regulation (EC) No 258/97.

                     (8)

                     On 2 August 2016, the Commission forwarded the initial assessment report to the other Member States. The Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97 agreed with the initial assessment report of Ireland.

                     (9)

                     In view of the initial assessment report conclusions issued by Ireland, to which the other Member States agreed, on 13 October 2016, the Commission consulted the European Food Safety Authority (‘the Authority’) asking it to carry out an additional assessment for pyrroloquinoline quinone disodium salt as a novel food ingredient in accordance with Regulation (EC) No 258/97.

                     (10)

                     On 24 October 2017, the Authority adopted ‘Scientific Opinion on the safety of pyrroloquinoline quinone disodium salt as a novel food pursuant to Regulation (EC) No 258/97’ (4). This opinion, although elaborated and adopted by the Authority under Regulation (EC) No 258/97 is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (11)

                     That opinion gives sufficient grounds to establish that pyrroloquinoline quinone disodium salt in the proposed uses and use levels when used as an ingredient in food supplements, complies with Article 12(1) of Regulation (EU) 2015/2283.

                     (12)

                     On 24 January 2018, the Applicant made a request to the Commission for protection of proprietary data for a number of studies submitted in support of the application namely, a bacterial reverse mutation test study (5), an in vitro chromosomal aberration test in human blood lymphocytes study (6), an in vitro chromosomal aberration test in Chinese hamster lung fibroblasts study (7), an in vivo micronucleus test study (8), a 14-day oral toxicity and a 90-day oral toxicity studies (9), and a 28-day renal toxicity study (10).

                     (13)

                     On 18 February 2018, the Authority considered (11) that in elaborating its opinion on pyrroloquinoline quinone disodium salt as a novel food, the data from the bacterial reverse mutation test and from the in vivo micronucleus test studies served as basis to alleviate concerns with respect to the potential genotoxity of pyrroloquinoline quinone disodium salt, and the 14-day oral, the 28-day renal toxicity, and the 90-day oral toxicity studies served as a basis to assess the toxicity profile of pyrroloquinoline quinone disodium salt and to establish the related No Observed Adverse Effect Level (NOAEL). Therefore, it is considered that the conclusions on the safety of pyrroloquinoline quinone disodium salt, could not have been reached without the data from the unpublished reports of these studies.

                     (14)

                     Following the receipt of the Authority's opinion, the Commission requested the Applicant to further clarify the justification provided with regard to their proprietary claim over the study reports, which were unpublished at the time the application was made, and to clarify their claim to an exclusive right of reference to those studies, as referred to in Article 26(2)(a)(b) of Regulation (EU) 2015/2283.

                     (15)

                     The Applicant has also declared that, at the time the application was submitted, they held proprietary or exclusive rights of reference to the studies under national law and that therefore third parties could not lawfully access or use those studies. 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.

                     (16)

                     Accordingly, as provided for under Article 26(2) of Regulation (EU) 2015/2283, the bacterial reverse mutation test, the in vivo micronucleus test studies, the 14-day oral toxicity, the 28-day renal toxicity, and the 90-day oral 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. As a consequence, the placing on the market within the Union of the novel food authorised by this Regulation should be restricted to the Applicant for a period of five years.

                     (17)

                     However, restricting the authorisation of this novel food 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.

                     (18)

                     Taking into account of the intended use in food supplements for the general adult population, and the fact that the request for authorisation excludes pregnant and lactating women, food supplements containing pyrroloquinoline quinone disodium salt should be appropriately labelled.

                     (19)

                     Directive 2002/46/EC of the European Parliament and of the Council (12) lays down requirements on food supplements. The use of pyrroloquinoline quinone disodium salt should be authorised without prejudice to that Directive.

                     (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

               1.   Pyrroloquinoline quinone disodium salt 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: Mitsubishi Gas Chemical Company, Inc.

                           Address: Mitsubishi Building 5-2 Marunouchi 2-chome, Chiyoda-ku, Tokyo 100-8324, Japan

                     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 Mitsubishi Gas Chemical Company, Inc.

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

               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 data protection 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 Mitsubishi Gas Chemical Company, 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 August 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (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)  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).

            (4)  EFSA Journal 2017; 15(11):5058.

            (5)  Mitsubishi Gas Chemical Company Inc., 2005b (unpublished report).

            (6)  Mitsubishi Gas Chemical Company Inc., 2008b (unpublished report).

            (7)  Mitsubishi Gas Chemical Company Inc., 2006d (unpublished report).

            (8)  Mitsubishi Gas Chemical Company Inc., 2006c (unpublished report).

            (9)  Mitsubishi Gas Chemical Company Inc., 2005a (unpublished report).

            (10)  Mitsubishi Gas Chemical Company Inc., 2006b (unpublished report).

            (11)  EFSA Scientific Panel on Dietetic Products, Nutrition and Allergies, Minutes of the 83rd Plenary held on 7-8 February 2018 and agreed on 18 February 2018.

            (12)  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).

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

                        (1)

                        the following last column is added in Table 1 (Authorised novel foods):
                        ‘Data Protection’

                        (2)

                        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

                                    ‘Pyrroloquinoline quinone disodium salt

                                       Specified food category

                                       Maximum levels

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be “Pyrroloquinoline quinone disodium salt”.
                                    Food supplements containing Pyrroloquinoline quinone disodium salt shall bear the following statement:
                                    This food supplement should be consumed by adults only excluding pregnant and lactating women

                                    Authorised on 2 September 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
                                    Applicant: Mitsubishi Gas Chemical Company, Inc., Mitsubishi Building 5-2 Marunouchi 2-chome, Chiyoda-ku, Tokyo 100-8324, Japan. During the period of data protection the novel food Pyrroloquinoline quinone disodium salt is authorised for placing on the market within the Union only by Mitsubishi Gas Chemical Company, Inc., unless a subsequent applicant obtains authorisation for the 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 Mitsubishi Gas Chemical Company, Inc.
                                    End date of the data protection: 2 september 2023’

                                    Food Supplements as defined in Directive 2002/46/EC intended for the adult population, excluding pregnant and lactating women

                                    20 mg/day

                        (3)

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

                                    Authorised Novel Food

                                    Specification

                                    ‘Pyrroloquinoline quinone disodium salt

                                       Definition:

                                    Chemical name: disodium 9-carboxy-4,5-dioxo-1H-pyrrolo[5,4-f]quinoline-2,7-dicarboxylate
                                    Chemical formula: C14H4N2Na2O8

                                    CAS No: 122628-50-6
                                    Molecular weight: 374,17 Da

                                       Description

                                    Pyrroloquinoline quinone disodium salt is a reddish–brown powder produced by the non-genetically modified bacterium Hyphomicrobium denitrificans strain CK-275.

                                       Characteristics/Composition

                                    Appearance: Reddish-brown powder
                                    Purity: ≥ 99,0 % (dry weight)
                                    UV absorbance (A322/A259): 0,56 ± 0,03
                                    UV absorbance (A233/A259): 0,90 ± 0,09
                                    Moisture: ≤ 12,0 %

                                       Residual Solvent

                                    Ethanol: ≤ 0,05 %

                                       Heavy metals

                                    Lead: < 3 mg/kg
                                    Arsenic: < 2 mg/kg

                                       Microbiological criteria:

                                    Total viable cell count: ≤ 300 CFU/g
                                    Mould/yeast: ≤ 12 CFU/g
                                    Coliforms: absent in 1 g

                                       Hyphomicrobium denitrificans: ≤ 25 CFU/g
                                    CFU: Colony Forming Units’


title: Council Implementing Regulation (EU) 2018/1115 of 10 August 2018 implementing Article 20(1) of Regulation (EU) 2015/735 concerning restrictive measures in respect of the situation in South Sudan

text:
                  13.8.2018

                  EN

                  Official Journal of the European Union

                  L 204/1

         COUNCIL IMPLEMENTING REGULATION (EU) 2018/1115
         of 10 August 2018
         implementing Article 20(1) of Regulation (EU) 2015/735 concerning restrictive measures in respect of the situation in South Sudan
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EU) 2015/735 of 7 May 2015 concerning restrictive measures in respect of the situation in South Sudan, and repealing Regulation (EU) No 748/2014 (1), and in particular Article 20(1) thereof,
         Having regard to the proposal of the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 7 May 2015, the Council adopted Regulation (EU) 2015/735.

                     (2)

                     On 13 July 2018, the United Nations Security Council adopted Resolution 2428 (2018) which notably adds two persons to the list of persons and entities subject to restrictive measures. These persons should therefore be added to Annex I to Regulation (EU) 2015/735. Since these two persons were already designated under Annex II to Regulation (EU) 2015/735, they should therefore be removed from Annex II to Regulation (EU) 2015/735 in order that they be designated under Annex I.

                     (3)

                     Annex I and II to Regulation (EU) 2015/735 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex I to Regulation (EU) 2015/735 is hereby amended as set out in Annex I to this Regulation.

            Article 2
            Annex II to Regulation (EU) 2015/735 is hereby amended as set out in Annex II to this Regulation.

            Article 3
            This Regulation shall enter into force on the day 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 August 2018.

                  For the Council

                  The President

               G. BLÜMEL

            (1)  OJ L 117, 8.5.2015, p. 13.

            ANNEX I
            The following persons are added to the list set out in Annex I to Regulation (EU) 2015/735:

               ‘7.   Malek REUBEN RIAK RENGU (alias: a) Malek Ruben)

               Title: Lieutenant General
               Designation: a) Deputy Chief of General Staff for Logistics; b) Deputy Chief of Defence Staff and Inspector General of the Army
               Date of birth: 1 Jan. 1960
               Place of birth: Yei, South Sudan
               Nationality: South Sudan
               Date of UN designation: 13 July 2018

                  Other information: As SPLA Deputy Chief of Staff for Logistics, Riak was one of the senior officials of the Government of South Sudan who planned and oversaw an offensive in Unity state in 2015 that resulted in widespread destruction and large population displacement.

                  Information from the narrative summary of reasons for listing provided by the Sanctions Committee:

               Malek Ruben Riak was listed on 13 July 2018 pursuant to paragraphs 6, 7 (a), and 8 of resolution 2206 (2015), as reaffirmed in resolution 2418 (2018), for “actions or policies that threaten the peace, security or stability of South Sudan”; “Actions or policies that have the purpose or effect of expanding or extending the conflict in South Sudan …,” and as a leader “of any entity, including any South Sudanese government, opposition, militia, or other group, that has, or whose members have, engaged in any of the activities described in paragraphs 6 and 7,” and pursuant to paragraph 14 (e) of this resolution for “planning, directing, or committing acts involving sexual and gender-based violence in South Sudan”.
               According to the report by the Panel of Experts on South Sudan in January 2016 (S/2016/70), Riak was one of a group of senior security officials who planned a Unity state offensive against the SPLM-IO beginning in January 2015, and subsequently oversaw its execution from late April 2015 onwards. The Government of South Sudan began arming Bul Nuer youth in early 2015 to facilitate their participation in the offensive. Most Bul Nuer youth already had access to AK-pattern automatic rifles, but ammunition was critical to sustaining their operations. The Panel of Experts reported evidence, including testimony from military sources, that ammunition was supplied to youth groups by SPLA headquarters specifically for the offensive. Riak was the SPLA Deputy Chief of Staff for Logistics at the time. The offensive resulted in systematic destruction of villages and infrastructure, the forced displacement of the local population, the indiscriminate killing and torturing of civilians, the widespread use of sexual violence, including against the elderly and children, the abduction and recruitment of children as soldiers, and large population displacement. Following the destruction of much of the southern and central parts of the state, numerous media and humanitarian organisations, as well as the United Nations Mission in South Sudan (UNMISS) published reports about the scale of the abuses that were perpetrated.
               8.   Paul MALONG AWAN (alias: a) Paul Malong Awan Anei, b) Paul Malong, c) Bol Malong)

               Title: General
               Designation: a) Former Chief of Staff of the Sudan People's Liberation Army (SPLA), b) Former Governor, Northern Bahr el-Ghazal State
               Date of birth: a) 1962, b) 4 Dec. 1960, c) 12 Apr. 1960
               Place of birth: Malualkon, South Sudan
               Nationality: a) South Sudan, b) Uganda
               Passport no: a) South Sudan number S00004370, b) South Sudan number D00001369, c) Sudan number 003606, d) Sudan number 00606, e) Sudan number B002606
               Date of UN designation: 13 July 2018

                  Other information: As Chief of General Staff of the SPLA, Malong expanded or extended the conflict in South Sudan through breaches of the Cessation of Hostilities Agreement and breaches of the 2015 Agreement on the Resolution of the Conflict in South Sudan (ARCSS). He reportedly directed efforts to kill opposition leader Riek Machar. He ordered SPLA units to prevent the transport of humanitarian supplies. Under Malong's leadership, the SPLA attacked civilians, schools and hospitals; forced the displacement of civilians; carried out enforced disappearances; arbitrarily detained civilians; and conducted acts of torture, and rape. He mobilised the Mathiang Anyoor Dinka tribal militia, which uses child soldiers. Under his leadership, the SPLA restricted UNMISS, the Joint Monitoring and Evaluation Commission (JMEC), and CTSAMM access to sites to investigate and document abuses.

                  Information from the narrative summary of reasons for listing provided by the Sanctions Committee:

               Paul Malong Awan was listed on 13 July 2018 pursuant to paragraphs 6, 7 (a), 7 (b), 7 (c), 7 (d), 7 (f), and 8 of resolution 2206 (2015), as reaffirmed in resolution 2418 (2018), for “actions or policies that have the purpose or effect of expanding or extending the conflict in South Sudan or obstructing reconciliation or peace talks or processes, including breaches of the Cessation of Hostilities Agreement”; “actions or policies that threaten transitional agreements or undermine the political process in South Sudan”; “the targeting of civilians, including women and children, through the commission of acts of violence (including killing, maiming, torture, or rape or other sexual violence), abduction, enforced disappearance, forced displacement, or attacks on schools, hospitals, religious sites, or locations where civilians are seeking refuge, or through conduct that would constitute a serious abuse or violation of human rights or a violation of international humanitarian law”; “planning, directing, or committing acts that violate applicable international human rights law or international humanitarian law, or acts that constitute human rights abuses, in South Sudan”; “The use or recruitment of children by armed groups or armed forces in the context of the armed conflict in South Sudan”; “the obstruction of the activities of international peacekeeping, diplomatic, or humanitarian missions in South Sudan, including IGAD's Monitoring and Verification Mechanism or of the delivery or distribution of, or access to, humanitarian assistance”; and as a leader “of any entity, including any South Sudanese government, opposition, militia, or other group, that has, or whose members have, engaged in any of the activities described in paragraphs 6 and 7”.
               Malong served as Chief of General Staff of the SPLA from April 23, 2014, to May 2017. In his former position as the Chief of General Staff, he expanded or extended the conflict in South Sudan through breaches of the Cessation of Hostilities Agreement and breaches of the 2015 Agreement on the Resolution of the Conflict in South Sudan (ARCSS). As of early August 2016, Malong reportedly directed efforts to kill South Sudanese opposition leader Riek Machar. Malong, knowingly countermanding President Salva Kiir's orders, ordered the 10 July 2016 tank, helicopter gunship, and infantry assaults on Machar's residence and the Sudan Peoples' Liberation Movement in Opposition (SPLM-IO)'s “Jebel” base. Malong personally oversaw efforts from SPLA headquarters to intercept Machar. As of early August 2016, Malong wanted the SPLA to attack Machar's suspected position immediately and informed SPLA commanders that Machar was not to be taken alive. In addition, in early 2016 information indicates that Malong ordered SPLA units to prevent the transport of humanitarian supplies across the Nile River, where tens of thousands of civilians were facing hunger, claiming that food aid would be diverted from civilians to militia groups. As a result of Malong's orders, food supplies were blocked from crossing the Nile for at least two weeks.
               Throughout his tenure as Chief of General Staff of the SPLA, Malong has been responsible for the SPLA and its allied forces' perpetration of serious abuses including attacks on civilians, forced displacement, enforced disappearances, arbitrary detentions, torture, and rape. Under Malong's leadership, the SPLA launched attacks directed against the civilian population and intentionally killed unarmed and fleeing civilians. In the Yei area alone, the UN documented 114 killings of civilians by the SPLA and its allied forces between July 2016 and January 2017. The SPLA intentionally attacked schools and hospitals. In April 2017, Malong allegedly ordered the SPLA to clear all people, including civilians from the area around Wau. Malong reportedly did not discourage the killing of civilians by the SPLA troops, and persons suspected of hiding rebels were considered legitimate targets.
               According to a 15 October 2014 African Union Commission of Inquiry on South Sudan report, Malong was responsible for the mass mobilisation of Mathiang Anyoor Dinka tribal militia, which Ceasefire and Transitional Security Arrangements Monitoring Mechanism (CTSAMM) documented use child soldiers.
               Under Malong's leadership of the SPLA, the government forces regularly restricted United Nations Mission in South Sudan (UNMISS), Joint Monitoring and Evaluation Commission (JMEC), and CTSAMM's access when they tried to investigate and document abuses. For example, on April 5, 2017, a joint UN and CTSAMM patrol tried to access Pajok but was turned back by SPLA soldiers.’

            ANNEX II
            The entries for the persons mentioned below are deleted in Annex II to Regulation (EU) 2015/735:

                        —

                                    1.

                                    Paul Malong;

                        —

                                    3.

                                    Malek Reuben Riak.


title: Commission Implementing Regulation (EU) 2018/1123 of 10 August 2018 authorising the placing on the market of 1-methylnicotinamide 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:
                  13.8.2018

                  EN

                  Official Journal of the European Union

                  L 204/41

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1123
         of 10 August 2018
         authorising the placing on the market of 1-methylnicotinamide 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 the Commission Implementing Regulation (EU) 2017/2470 (2) was adopted, which establishes a Union list of authorised novel foods.

                     (3)

                     Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on updating the Union list.

                     (4)

                     On 18 September 2013, the company Pharmena SA (‘the Applicant’) made a request to the competent authority of the United Kingdom to place synthetic 1-methylnicotinamide chloride on the Union market as a novel food ingredient within the meaning of point (c) of Article 1(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council (3). The application requests for 1-methylnicotinamide chloride to be used in food supplements for the general adult population, excluding pregnant and lactating women.

                     (5)

                     Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 and for which the final decision has not been taken before 1 January 2018, shall be treated as an application submitted under Regulation (EU) 2015/2283.

                     (6)

                     While the request for placing 1-methylnicotinamide chloride on the market as a novel food within the Union was submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, the application also meets the requirements laid down in Regulation (EU) 2015/2283.

                     (7)

                     On 26 November 2015, the competent authority of the United Kingdom issued its initial assessment report. In that report, it came to the conclusion that 1-methylnicotinamide chloride meets the criteria for novel food ingredient set out in Article 3(1) of Regulation (EC) No 258/97.

                     (8)

                     On 11 December 2015, the Commission forwarded the initial assessment report to the other Member States. Reasoned objections were raised by other Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97 with regard to the safety and tolerance of 1-methylnicotinamide chloride, and in particular on the effects on consumer health of the long-term intake of 1-MNA, especially when taking into account the intake of niacin from the diet, including food supplements.

                     (9)

                     In view of the objections raised by the other Member States, on 11 August 2016, the Commission consulted the European Food Safety Authority (‘the Authority’) asking it to carry out an additional assessment for 1-methylnicotinamide chloride as novel food ingredient in accordance with Regulation (EC) No 258/97

                     (10)

                     On 20 September 2017, the Authority adopted ‘Scientific Opinion on the safety of 1-methylnicotinamide chloride as a novel food pursuant to Regulation (EC) No 258/97’ (4). This opinion, although elaborated and adopted by EFSA under Regulation (EC) No 258/97 is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (11)

                     That opinion gives sufficient grounds to establish that 1-methylnicotinamide chloride in the proposed uses and use levels when used as an ingredient in food supplements, complies with Article 12(1) of Regulation (EU) 2015/2283.

                     (12)

                     On 25 January 2018, the Applicant made a request to the Commission for protection of proprietary data for a number of studies submitted in support of the application namely, the methods of analysis (5), an animal toxicity and pharmacokinetic study (6), a human pharmacokinetic study (7), an in vitro micronucleus test with human lymphocytes study (8), a human lipid metabolism study (9), a 90-day sub chronic oral toxicity study (10), and a single dose human bioavailability study (11).

                     (13)

                     On 18 February 2018, the Authority considered that in elaborating its opinion on 1-methylnicotinamide chloride as a novel food, the methods of analysis served as the basis to assess the specifications and the composition of 1-methynicotinamide, the in vitro micronucleus test study with human lymphocytes served as the basis to conclude that there were no concerns with respect to the genotoxicity of 1-methylnicotinamide chloride, and the 90-day oral toxicity study served as the basis to establish a reference point and to assess whether the margin of exposure in relation to the proposed maximum intake of 1-methylnicotinamide chloride by humans is sufficient.

                     (14)

                     Following the receipt of the Authority's opinion, the Commission requested the Applicant to further clarify the justification provided with regard to their proprietary claim over the studies, which were unpublished at the time the application was submitted, and to clarify their claim to an exclusive right of reference to those studies, as referred to in Article 26(2)(a)(b) of Regulation (EU) 2015/2283.

                     (15)

                     The Applicant has also declared that, at the time the application was submitted, they held proprietary or exclusive rights of reference to the studies under national law and that therefore third parties could not lawfully access or use those studies. 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.

                     (16)

                     Accordingly, as provided for under Article 26(2) of Regulation (EU) 2015/2283, the methods of analysis of 1-methylnicotinamide chloride, the in vitro micronucleus test with human lymphocytes study, and the 90-day sub chronic oral toxicity study 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. As a consequence, the placing on the market within the Union of the novel food authorised by this Regulation should be restricted to the Applicant for a period of five years.

                     (17)

                     However, restricting the authorisation of this novel food 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 available outside the Applicant's file supporting the authorisation under this Regulation.

                     (18)

                     Taking into account of the intended use in food supplements for the general adult population, and the fact that the request for authorisation excludes pregnant and lactating women, food supplements containing 1-methylnicotinamide chloride should be appropriately labelled.

                     (19)

                     Directive 2002/46/EC of the European Parliament and of the Council (12) lays down requirements on food supplements. The use of 1-methylnicotinamide chloride should be authorised without prejudice to that Directive.

                     (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

               1.   1-methylnicotinamide 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: Pharmena SA

                           Address: ul. Wolczanska 178, 90 530 Lodz, Poland

                     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 Pharmena SA.

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

               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 data protection 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 Pharmena SA.

            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 August 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (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)  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).

            (4)  EFSA Journal 2017; 15(10):5001.

            (5)  Unpublished internal company report.

            (6)  Przybyła M., 2013, unpublished report.

            (7)  Proskin, H.M., 2008, unpublished report.

            (8)  Stepnik M., 2012, unpublished report.

            (9)  Cossette M., 2009, unpublished report.

            (10)  Ford J.A., 2014, unpublished study.

            (11)  Dessouki E., 2013, unpublished study.

            (12)  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).

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

                        (1)

                        the following last column is added in Table 1 (Authorised novel foods):
                        ‘Data Protection’

                        (2)

                        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

                                    ‘1-Methylnicotinamide chloride

                                       Specified food category

                                       Maximum levels

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be “1- Methylnicotinamide chloride”.
                                    Food supplements containing 1-Methylnicotinamide shall bear the following statement:
                                    This food supplement should be consumed by adults only excluding pregnant and lactating women

                                    Authorised on 2 September 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
                                    Applicant: Pharmena SA, Wolczanska 178, 90 530 Lodz, Poland. During the period of data protection the novel food 1-methylnicotinamide chloride is authorised for placing on the market within the Union only by Pharmena S.A. unless a subsequent applicant obtains authorisation for the 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 Pharmena S.A.
                                    End date of the data protection: 2 September 2023’.

                                    Food Supplements as defined in Directive 2002/46/EC for the adult population excluding pregnant and lactating women

                                    58 mg/day

                        (3)

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

                                    Authorised Novel Food

                                    Specification

                                    ‘1-Methylnicotinamide chloride

                                       Definition:

                                    Chemical name: 3-carbamoyl-1-methyl-pyridinium chloride
                                    Chemical formula: C7H9N2OCl
                                    CAS No: 1005-24-9
                                    Molecular weight: 172,61 Da

                                       Description

                                    1-Methylnicotinamide chloride is white or off-white, crystalline solid produced by a chemical synthesis process.

                                       Characteristics/Composition

                                    Appearance: White – off-white, crystalline solid
                                    Purity: ≥ 98,5 %
                                    Trigonelline: ≤ 0,05 %
                                    Nicotinic Acid: ≤ 0,10 %
                                    Nicotinamide: ≤ 0,10 %
                                    Largest unknown impurity: ≤ 0,05 %
                                    Sum of unknown impurities: ≤ 0,20 %
                                    Sum of all impurities: ≤ 0,50 %
                                    Solubility: soluble in water and methanol. Practically insoluble in 2-propanol and dichloromethane
                                    Moisture: ≤ 0,3 %
                                    Loss on drying: ≤ 1,0 %
                                    Residue on ignition: ≤ 0,1 %

                                       Residual Solvents and Heavy Metals

                                    Methanol: ≤ 0,3 %
                                    Heavy metals: ≤ 0,002 %

                                       Microbiological criteria:

                                    Total aerobic microbial count: ≤ 100 CFU/g
                                    Mould/yeast: ≤ 10 CFU/g
                                    Enterobacteriaceae: absence in 1 g

                                       Pseudomonas aeruginosa: absence in 1 g

                                       Staphylococcus aureus: absent in 1 g
                                    CFU: Colony Forming Units’