title: Commission Implementing Regulation (EU) 2018/983 of 11 July 2018 concerning the authorisation of benzoic acid as a feed additive for minor porcine species for fattening and for reproduction (holder of authorisation DSM Nutritional Products Sp. z o. o.) (Text with EEA relevance.)

text:
                  12.7.2018

                  EN

                  Official Journal of the European Union

                  L 176/17

            COMMISSION IMPLEMENTING REGULATION (EU) 2018/983
      of 11 July 2018
      concerning the authorisation of benzoic acid as a feed additive for minor porcine species for fattening and for reproduction (holder of authorisation DSM Nutritional Products Sp. z o. o.)
      (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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
      Whereas:

                  (1)

                  Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

                  (2)

                  In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of benzoic acid as a feed additive for minor porcine species for fattening and for reproduction. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                  (3)

                  That application concerns the authorisation of benzoic acid as a feed additive for minor porcine species for fattening and for reproduction, to be classified in the additive category ‘zootechnical additives’.

                  (4)

                  That additive was already authorised as a feed additive for use in weaned piglets by Commission Regulation (EC) No 1730/2006 (2), in pigs for fattening by Commission Regulation (EC) No 1138/2007 (3) and in sows by Commission Implementing Regulation (EU) 2016/900 (4).

                  (5)

                  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 September 2017 (5) that, under the proposed conditions of use, the benzoic acid does not have an adverse effect on human health or the environment, and that it has a potential to decrease urinary pH in minor porcine species. However, due to the lack of margin of safety in weaned major piglets, the Authority could not extrapolate the conclusion on the safety to weaned minor porcine species. Therefore it was established the additive is safe for minor porcine species for fattening and for reproduction. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                  (6)

                  The assessment of the benzoic acid shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

                  (7)

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

            HAS ADOPTED THIS REGULATION:
      Article 1
      The additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
      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, 11 July 2018.

               For the Commission

               The President

            Jean-Claude JUNCKER

         (1)  OJ L 268, 18.10.2003, p. 29.

         (2)  Commission Regulation (EC) No 1730/2006 of 23 November 2006 concerning the authorisation of benzoic acid (VevoVitall) as a feed additive (OJ L 325, 24.11.2006, p. 9).

         (3)  Commission Regulation (EC) No 1138/2007 of 1 October 2007 concerning the authorisation of a new use of benzoic acid (VevoVitall) as a feed additive (OJ L 256, 2.10.2007, p. 8).

         (4)  Commission Implementing Regulation (EU) 2016/900 of 8 June 2016 concerning the authorisation of benzoic acid as a feed additive for sows (holder of authorisation DSM Nutritional Products Ltd) (OJ L 152, 9.6.2016, p. 18).

         (5)  EFSA Journal 2017;15(10):5026.

         ANNEX

                     Identification number of the additive

                     Name of the holder of authorisation

                     Additive

                     Composition, chemical formula, description, analytical method

                     Species or category of animal

                     Maximum age

                     Minimum content

                     Maximum content

                     Other provisions

                     End of period of authorisation

                     mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

                        Category of zootechnical additives. Functional group: other zootechnical additives (urinary pH decrease).

                     4d210

                     DSM Nutritional Products Sp. z o. o.

                     Benzoic acid

                        Additive composition:

                     Benzoic acid (≥ 99,9 %)

                        Characterisation of the active substance:

                     Benzenecarboxylic acid, phenylcarboxylic acid,
                     C7H6O2

                     CAS number 65-85-0
                     Maximum level of the impurities:

                                 Phthalic acid: ≤ 100 mg/kg

                                 Biphenyl: ≤ 100 mg/kg

                        Analytical method
                         (1)

                     For the quantification of benzoic acid in the feed additive:

                                 —

                                 titration with sodium hydroxide (European Pharmacopoeia monograph 0066)

                           For the quantification of the benzoic acid in the premixtures and feedingstuffs:

                                 —

                                 reversed phase liquid chromatography with UV detection (RP-HPLC/UV) — method based on ISO9231:2008

                     Minor porcine species for fattening and for reproduction

                     —

                     5 000

                     5 000

                                 1.

                                 In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated..

                                 2.

                                 The additive shall not be used with other sources of benzoic acid or benzoates.

                                 3.

                                 The directions of use shall be indicated the following in complementary feed: ‘Complementary feedingstuffs containing benzoic acid shall not be fed to minor porcine species for fattening and for reproduction as such'. Complementary feedingstuffs for sows shall be thoroughly mixed with other feed materials of the daily ration’.

                                 4.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks concerning their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eyes and skin protection.

                     1 August 2028

            (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports


title: Commission Implementing Regulation (EU) 2018/980 of 11 July 2018 amending Implementing Regulation (EU) No 815/2012, as regards the information to be exchanged between Member States to identify taxable persons using the non-Union scheme

text:
               12.7.2018

               EN

               Official Journal of the European Union

               L 176/9

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/980
   of 11 July 2018
   amending Implementing Regulation (EU) No 815/2012, as regards the information to be exchanged between Member States to identify taxable persons using the non-Union scheme
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EU) No 904/2010 of 7 October 2010 on administrative cooperation and combating fraud in the field of value added tax (1) and in particular Article 44(1), the second subparagraph of Article 44(2), Article 45(1) and (2), and Article 51(1) thereof,
   Whereas:

               (1)

               Commission Implementing Regulation (EU) No 815/2012 (2) lays down detailed rules for the application of Regulation (EU) No 904/2010, in particular as regards the transmission of registration information of taxable persons using special schemes for telecommunications services, broadcasting services or electronic services provided for in Chapter 6 of Title XII of Council Directive 2006/112/EC (3).

               (2)

               Following the amendment of Articles 358a and 361 of Directive 2006/112/EC by Council Directive (EU) 2017/2455 (4), taxable persons not established in the Community who are identified for value added tax (VAT) purposes within the Community will be able as of 1 January 2019 to use the special scheme, set out in Section 2 of Chapter 6 of Title XII of Directive 2006/112/EC (the ‘non-Union scheme’), for telecommunications services, broadcasting services or electronic services supplied to non-taxable persons who are established in a Member State or have their permanent address or usually reside in a Member State.

               (3)

               The common electronic message for the transmission of information to identify taxable persons using the non-Union scheme set out in column B of the table in Annex I to Implementing Regulation (EU) No 815/2012 should therefore be amended accordingly.

               (4)

               For reasons of consistency, this Regulation should apply from the same date as the provisions of Directive (EU) 2017/2455 introducing the possibility for taxable persons not established in the Community who are identified for VAT purposes within the Community to use the special scheme.

               (5)

               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Administrative Cooperation,

         HAS ADOPTED THIS REGULATION:
   Article 1
   In column B of the table in Annex I to Implementing Regulation (EU) No 815/2012, the text in box number 16 is replaced by the following:

      ‘Electronic declaration that the taxable person is not established within the Union’.

   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 January 2019.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 11 July 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 268, 12.10.2010, p. 1.

      (2)  Commission Implementing Regulation (EU) No 815/2012 of 13 September 2012 laying down detailed rules for the application of Council Regulation (EU) No 904/2010, as regards special schemes for non-established taxable persons supplying telecommunications, broadcasting or electronic services to non-taxable persons (OJ L 249, 14.9.2012, p. 3).

      (3)  Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax (OJ L 347, 11.12.2006, p. 1).

      (4)  Council Directive (EU) 2017/2455 of 5 December 2017 amending Directive 2006/112/EC and Directive 2009/132/EC as regards certain value added tax obligations for supplies of services and distance sales of goods (OJ L 348, 29.12.2017, p. 7).


title: Commission Implementing Regulation (EU) 2018/981 of 11 July 2018 amending the list of Brazilian establishments from which imports into the Union of fishery products intended for human consumption are permitted (Text with EEA relevance.)

text:
               12.7.2018

               EN

               Official Journal of the European Union

               L 176/11

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/981
   of 11 July 2018
   amending the list of Brazilian establishments from which imports into the Union of fishery products intended for human consumption are permitted
   (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 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (1), and in particular Article 12(4)(c) thereof,
   Whereas:

               (1)

               Regulation (EC) No 854/2004 lays down specific rules for the organisation of official controls on products of animal origin. In particular, Article 12(1) of that Regulation provides that, with the exception of certain specific cases, products of animal origin are to be imported into the Union only if they originate from third country establishments that appear on lists drawn up and updated in accordance with that Article. Those lists can be consulted on the website of the Directorate-General for Health and Food Safety (2).

               (2)

               Article 12(2) of Regulation (EC) No 854/2004 requires that third country establishments are placed on those lists only if the competent authorities of the third country guarantee that those establishments, together with any establishments handling raw material of animal origin used in the manufacture of the products of animal origin concerned, comply with relevant Union requirements. In addition, in accordance with Article 12(3) of Regulation (EC) No 854/2004, the competent authorities of the third country concerned should keep those lists of establishments updated and communicate them accordingly to the Commission.

               (3)

               Article 15(2)(a) of Regulation (EC) No 854/2004 provides that fishery products imported from a factory or freezer vessel flying the flag of a third country are to come from vessels that appear on a list drawn up and updated in accordance with the procedure set out in Article 12(4) of that Regulation.

               (4)

               In September 2017, a Commission inspection revealed that primary production establishments supplying Brazilian establishments from which imports of fishery products are permitted are neither identified, nor subject to official controls. Consequently, that audit concluded that the competent authority in Brazil is neither in the position to provide the guarantees set out in Article 12(2)(a) and (b) of Regulation (EC) No 854/2004, nor to provide all the guarantees referred to in the health certificate for fishery products laid down in Appendix IV to Annex VI to Commission Regulation (EC) No 2074/2005 (3). Moreover, that inspection revealed serious deficiencies with regard to infrastructure and hygiene requirements in a number of inspected Brazilian establishments from which imports of fishery products are permitted. The aforesaid deficiencies have shown a systemic lack of effective controls by the Brazilian competent authorities with regard to fishery products.

               (5)

               In reply to the recommendations made in the preliminary inspection report, the Brazilian authorities informed the Commission, in an official letter dated 22 December 2017, that they have suspended the issuance of health certificates for all fishery products intended for export to the Union as of 3 January 2018. However, Member States notified the Commission that consignments of fishery products originating from Brazil were presented at the Union borders with certificates issued after the date of suspension.

               (6)

               In light of these considerations, and in the absence of new information from the Brazilian authorities, there are no sufficient guarantees that any of the establishments authorised to export fishery products from Brazil to the Union fulfil the conditions of Article 12(2) of Regulation (EC) No 854/2004 and their products therefore constitute a risk for public health. It is therefore appropriate to remove all establishments from the list of Brazilian establishments from which fishery products intended for human consumption can be imported into the Union.

               (7)

               In light of the risk to public health associated with their products, those establishments should cease to be authorised to export to the Union without delay. It is therefore appropriate that the date of entry into force of this Regulation is the date following that of its publication.

               (8)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   The list of establishments referred to in Article 12 of Regulation (EC) No 854/2004 shall be amended in order to remove all entries of Brazilian establishments from which imports into the Union of fishery products for human consumption are permitted.
   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, 11 July 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 139, 30.4.2004, p. 206.

      (2)  https://ec.europa.eu/food/safety/international_affairs/trade/non-eu-countries_en

      (3)  Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 (OJ L 338, 22.12.2005, p. 27).


title: Commission Implementing Regulation (EU) 2018/982 of 11 July 2018 concerning the authorisation of the preparation of benzoic acid, calcium formate and fumaric acid as feed additive for chickens for fattening and chickens reared for laying (holder of the authorisation Novus Europe N.A./S.V.) (Text with EEA relevance.)

text:
                  12.7.2018

                  EN

                  Official Journal of the European Union

                  L 176/13

            COMMISSION IMPLEMENTING REGULATION (EU) 2018/982
      of 11 July 2018
      concerning the authorisation of the preparation of benzoic acid, calcium formate and fumaric acid as feed additive for chickens for fattening and chickens reared for laying (holder of the authorisation Novus Europe N.A./S.V.)
      (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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
      Whereas:

                  (1)

                  Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

                  (2)

                  In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of the preparation of benzoic acid, calcium formate and fumaric acid as a feed additive for chickens for fattening, chickens reared for laying, minor avian species for fattening and reared for laying. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                  (3)

                  That application concerns the authorisation of the preparation of benzoic acid, calcium formate and fumaric acid as a feed additive for chickens for fattening, chickens reared for laying, minor avian species for fattening and reared for laying, to be classified in the additive category ‘zootechnical additives’.

                  (4)

                  The European Food Safety Authority (‘the Authority’) concluded in its opinions of 2 December 2014 (2) and 28 September 2017 (3) that, under the proposed conditions of use, the preparation of benzoic acid, calcium formate and fumaric acid does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that it has the potential to improve the performance of chickens for fattening and this conclusion can be extended to chickens reared for laying. However, since no conclusions can be drawn on the margin of safety of the additive for major target species, the conclusions on safety cannot be extrapolated to minor avian species for fattening and to minor avian species reared for laying. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                  (5)

                  The assessment of the preparation of benzoic acid, calcium formate and fumaric acid shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

                  (6)

                  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
      The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
      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, 11 July 2018.

               For the Commission

               The President

            Jean-Claude JUNCKER

         (1)  OJ L 268, 18.10.2003, p. 29.

         (2)  EFSA Journal 2015;13(5):3794.

         (3)  EFSA Journal 2017;15(10):5025.

         ANNEX

                     Identification number of the additive

                     Name of the holder of authorisation

                     Additive

                     Composition, chemical formula, description, analytical method

                     Species or category of animal

                     Maximum age

                     Minimum content

                     Maximum content

                     Other provisions

                     End of period of authorisation

                     mg of additive/kg of complete feedingstuff with a moisture content of 12 %

                        Category of zootechnical additives. Functional group: other zootechnical additives (improving zootechnical performance)

                     4d14

                     Novus Europe N.A./S.V.

                     Preparation of benzoic acid, calcium formate and fumaric acid

                        Additive composition

                     Preparation of benzoic acid, calcium formate and fumaric acid having a minimum content of:

                                 Benzoic acid: 42,5-50 %

                                 Calcium formate: 2,5-3,5 %

                                 Fumaric acid: 0,8-1,2 %

                           Granulated form

                        Characterisation of the active substance

                     benzoic acid CAS number: 65-85-0 (≥ 99,0 % purity); C7H6O2

                     calcium formate: CAS number 544-17-2; C2H2O4Ca;
                     fumaric acid (≥ 99,5 % purity): CAS number 110-17-8; C4H4O4.

                        Analytical method
                         (1)

                     For the determination of benzoic acid, calcium formate and fumaric acid in the feed additive:

                                 —

                                 high performance liquid chromatography with UV detection (HPLC-UV)

                           For the determination of total calcium in the feed additive:

                                 —

                                 atomic absorption spectrometry (AAS) – EN ISO 6869; or

                                 —

                                 inductively coupled plasma atomic emission spectrometry (ICP-AES) – EN 15510

                           For the determination of benzoic acid in premixtures and feedingstuffs:

                                 —

                                 high performance liquid chromatography with UV detection (HPLC-UV)

                           For the determination of calcium formate and fumaric acid in premixtures:

                                 —

                                 ion-exclusion high performance liquid chromatography with UV or refractive index detection (HPLC-UV/RI)

                     Chickens for fattening
                     Chickens reared for laying

                     —

                     500

                     1 000

                                 1.

                                 In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

                                 2.

                                 The additive shall not be used with other sources of benzoic acid or benzoates, calcium formate or formate and fumaric acid.

                                 3.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks concerning their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

                     1 August 2028

            (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports


title: Commission Implementing Regulation (EU) 2018/1204 of 27 August 2018 amending for the 290th time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaida organisations

text:
                  27.8.2018

                  EN

                  Official Journal of the European Union

                  LI 217/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1204
         of 27 August 2018
         amending for the 290th time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaida organisations
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 881/2002 of 27 May 2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaida organisations (1), and in particular Article 7(1)(a) and Article 7a(1) thereof,
         Whereas:

                     (1)

                     Annex I to Regulation (EC) No 881/2002 lists the persons, groups and entities covered by the freezing of funds and economic resources under that Regulation.

                     (2)

                     On 23 August 2018, the Sanctions Committee of the United Nations Security Council decided to add three entries to the list of persons, groups and entities to whom the freezing of funds and economic resources should apply. Annex I to Regulation (EC) No 881/2002 should therefore be amended accordingly.

                     (3)

                     In order to ensure that the measures provided for in this Regulation are effective it should enter into force immediately.

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex I to Regulation (EC) No 881/2002 is amended in accordance with the Annex to this Regulation.

            Article 2
            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, 27 August 2018.

                  For the Commission,

                  On behalf of the President,

                  Head of the Service for Foreign Policy Instruments

            (1)  OJ L 139, 29.5.2002, p. 9.

            ANNEX
            In Annex I to Regulation (EC) No 881/2002 the following entries are added under the heading ‘Natural persons’:

                        ‘—

                        Mohammed Yusip Karim (alias (a) Abu Walid al Indunisi (b) Zidni Elma (c) Udtadz Syaifudin (d) Mohammad Yusef Karim Faiz (e) Muh Saifudin (f) Kembar Khalid (g) Mohamad Yusuf Karim Saifullah Faiz (h) Mohammad Saifuddin Mohammad Yusuf Faiz (i) Ustadz Faiz (j) Saifudin Faiz (k) Kholid Faiz (l) Abdullah Faiz (m) Fauz Faturohman. Date of birth: 11.10.1978. Place of birth: Indonesia. Address: Syrian Arab Republic (location since 2015). Nationality: Indonesia. Other information: Senior member of Islamic State in Iraq and the Levant (ISIL), listed as Al-Qaida in Iraq. Recruited for ISIL and instructed individuals to perpetrate terrorist acts via online video. Physical description: hair colour: black; build: slight. Speaks Indonesian, Arabic and Mindanao dialect. Date of designation referred to in Article 7d(2)(i): 23.8.2018.

                        —

                        Mohamad Rafi Bin Udin (alias (a) Mohd Radi Bin Udin (b) Abu Awn al Malizi (c) Muhammad Ratin (d) Muhammad Rafiuddin (e) Abu Una al Malayzie (f) Mhammad Rahim Bin Udin (g) Abu Ayn Tok Cit (h) Muhammad Ratin Bin Nurdin). Date of birth: 3.6.1966. Place of birth: Negri Sembilan, Malaysia. Address: (a) B-3B-19 Glenview Villa, Jalan 49 Off Jalan Kuari, Taman Pinggiran Cheras, 56000 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia (as of 30 January 2014), (b) 90-00-04 Flat Sri Kota, Bandar Tun Razak, 56100, Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia (as of 23 April 2010), (c) 96-06-06 Flat Sri Kota, Bandar Tun Razak, 56100, Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia (as of 06 April 2007), (d) Syrian Arab Republic (location since 2014). Nationality: (a) Malaysia, (b) Indonesia. Passport No: Malaysia number A31142734, issued on 06 November 2013 (issued by the Immigration Department of Malaysia, expiration date 6 Nov. 2015). National identification no.: Malaysia National Identification Card 660603-05-5267 (issued by National Registration Department of Malaysia; issued to Mohd Rafi bin Udin). Other information: Senior member of Islamic State in Iraq and the Levant (ISIL), listed as Al-Qaida in Iraq. Recruited for ISIL and instructed individuals to perpetrate terrorist acts via online video. Physical description: eye colour: brown; hair colour: brown; complexion: dark. Speaks Malay, English, limited Arabic. Date of designation referred to in Article 7d(2)(i): 23.8.2018.

                        —

                        Muhammed Reza Lahaman Kiram (alias (a) Abdul Rahman (b) Abu Abdul Rahman al Filipini (c) Abtol Rahman). Date of birth: 3.3.1990. Place of birth: Zamboanga City, Zamboanga del Sur, Philippines. Address: (a) Brgy Recodo, Zamboanga City, Western Mindanao, Philippines (previous address), (b) 96 IlangLlang, Sarmiento Subdivision, Panabo, Davao City, Eastern Mindanao, Philippines (previous address), (c) Syrian Arab Republic (location since 2015). Nationality: Philippines. Passport no: (a) Philippines number XX3966391 (issued on 25.2.2015 by the Department of Foreign Affairs of Philippines, expiration date 24.2.2020), (b) Philippines number EC3524065. Other information: Senior member of Islamic State in Iraq and the Levant (ISIL), listed as Al-Qaida in Iraq. Recruited for ISIL and instructed individuals to perpetrate terrorist acts via online video. Physical description: height: 156cm; weight: 60 kg (as at Sep. 2016); eye colour: black; hair colour: black; build: medium; high cheekbones. Speaks Tagalog, English, Arabic. Date of designation referred to in Article 7d(2)(i): 23.8.2018.’


title: Council Implementing Regulation (EU) 2018/1245 of 18 September 2018 implementing Article 21(1) of Regulation (EU) 2016/44 concerning restrictive measures in view of the situation in Libya

text:
                  19.9.2018

                  EN

                  Official Journal of the European Union

                  L 235/1

         COUNCIL IMPLEMENTING REGULATION (EU) 2018/1245
         of 18 September 2018
         implementing Article 21(1) of Regulation (EU) 2016/44 concerning restrictive measures in view of the situation in Libya
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EU) 2016/44 of 18 January 2016 concerning restrictive measures in view of the situation in Libya, and repealing Regulation (EU) No 204/2011 (1), and in particular Article 21(1) thereof,
         Having regard to the proposal of the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 18 January 2016 the Council adopted Regulation (EU) 2016/44.

                     (2)

                     On 11 September 2018 the United Nations Security Council (‘UNSC’) Committee established pursuant to UNSC Resolution 1970 (2011) added one person to the list of persons and entities subject to restrictive measures.

                     (3)

                     Annex II to Regulation (EU) 2016/44 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex II to Regulation (EU) 2016/44 is amended as set out in the Annex to this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 18 September 2018.

                  For the Council

                  The President

               G. BLÜMEL

            (1)  OJ L 12, 19.1.2016, p. 1.

            ANNEX
            The following person is added to the list in Annex II of Regulation (EU) 2016/44:

                           ‘27.

                              Name: 1: Ibrahim 2: Saeed 3: Salim 4: Jadhran

                              Title: na Designation: Leader of armed militias DOB: 1982 POB: na Good quality a.k.a.: na Low quality a.k.a.: na Nationality: Libya Passport no: na National identification no: na Address: na Listed on: 11 Sept. 2018. Other information: name of mother Salma Abdula Younis.Listed pursuant to paragraphs 15 and 17 of resolution 1970 (Travel Ban, Asset Freeze). INTERPOL-UN Security Council Special Notice web link: www.interpol.int/en/notice/search/un/xxxx.
                           Listed pursuant to paragraphs 11 (b), 11 (c) and 11 (d) of resolution 2213 (2015); paragraph 11 of resolution 2362 (2017).
                           Additional information:

                                       —

                                       Libya's Attorney General's Office has issued an arrest warrant against the person concerned accusing him of perpetrating a number of crimes.

                                       —

                                       The person concerned carried out armed actions and attacks against oil installations located in the oil crescent region that caused its destruction, the latest of which was on 14 June 2018.

                                       —

                                       The attacks on the crescent oil region resulted in many casualties among the inhabitants of the region and endangered the lives of civilians.

                                       —

                                       The attacks intermittently halted Libyan oil exports from 2013 to 2018, which led to significant losses for the Libyan economy.

                                       —

                                       The person concerned attempted to export oil illegally.

                                       —

                                       The person concerned recruits foreign fighters for his repeated attacks against “oil crescent” region.

                                       —

                                       The person concerned, through his actions, is working against the stability of Libya, and constitutes an obstacle in the way of the Libyan parties to resolve the political crisis and implement the United Nations Plan of Action.’


title: Commission Implementing Regulation (EU) 2018/1484 of 4 October 2018 on the minimum selling price for skimmed milk powder for the 25th partial invitation to tender within the tendering procedure opened by Implementing Regulation (EU) 2016/2080

text:
                  5.10.2018

                  EN

                  Official Journal of the European Union

                  L 251/24

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1484
         of 4 October 2018
         on the minimum selling price for skimmed milk powder for the 25th partial invitation to tender within the tendering procedure opened by Implementing Regulation (EU) 2016/2080
         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),
         Having regard to Commission Implementing Regulation (EU) 2016/1240 of 18 May 2016 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council with regard to public intervention and aid for private storage (2), and in particular Article 32 thereof,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) 2016/2080 (3) has opened the sale of skimmed milk powder by a tendering procedure.

                     (2)

                     In the light of the tenders received for the 25th partial invitation to tender, a minimum selling price should be fixed.

                     (3)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            For the 25th partial invitation to tender for the selling of skimmed milk powder within the tendering procedure opened by Implementing Regulation (EU) 2016/2080, in respect of which the period during which tenders were to be submitted ended on 2 October 2018, the minimum selling price shall be 123 EUR/100 kg.

            Article 2
            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, 4 October 2018.

                  For the Commission,

                  On behalf of the President,

               Jerzy PLEWA

                  Director-General

                  Directorate-General for Agriculture and Rural Development

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

            (2)  OJ L 206, 30.7.2016, p. 71.

            (3)  Commission Implementing Regulation (EU) 2016/2080 of 25 November 2016 opening the sale of skimmed milk powder by a tendering procedure (OJ L 321, 29.11.2016, p. 45).


title: Commission Implementing Regulation (EU) 2018/1489 of 3 October 2018 concerning the classification of certain goods in the Combined Nomenclature

text:
                  8.10.2018

                  EN

                  Official Journal of the European Union

                  L 252/35

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1489
         of 3 October 2018
         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, 3 October 2018.

                  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 article of plastics in the form of a set put up for retail sale consisting of:

                                    —

                                    three garden hose couplings,

                                    —

                                    a spray nozzle with a mechanism for the adjustment of the water jet type as well as for closing or opening the flow,

                                    —

                                    connectors equipped with rubber seals (so called ‘O-rings’).

                              The article is presented to be used in gardens to sprinkle and water the plants.
                        See images (*1).

                        8481 80 99

                        Classification is determined by general rules 1, 3(b) and 6 for the interpretation of the Combined Nomenclature, and by the wording of CN codes 8481 , 8481 80  and 8481 80 99 .
                        The spray nozzle, which changes the water jet type and regulates the liquid flow, gives the set its essential character.
                        The article is neither an irrigation system (see also the Harmonised System Explanatory Notes (HSEN) to heading 8424 , (E)), nor a mechanical garden sprinkler head. It has the objective characteristics of a hose pipe nozzle fitted with taps, cocks, valves or other appliances for regulating the liquid flow and the jet type, which is excluded from heading 8424  (see also the HSEN to heading 8424  (D)). Hose pipe nozzles and the like, fitted with cocks or with valves for forming a jet or a spray are classified in heading 8481  (see also the HSEN to heading 8481 , point (11). Consequently, classification under heading 8424  is excluded.
                        The article is therefore to be classified in CN code 8481 80 99  as other valves.

               (*1)  The images are purely for information.


title: Commission Implementing Regulation (EU) 2018/1632 of 30 October 2018 authorising the placing on the market of bovine milk basic whey protein isolate 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:
                  31.10.2018

                  EN

                  Official Journal of the European Union

                  L 272/23

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1632
         of 30 October 2018
         authorising the placing on the market of bovine milk basic whey protein isolate 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 and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

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

                     (2)

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

                     (3)

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

                     (4)

                     On 22 August 2016, the company Armor Protéines S.A.S. (‘the Applicant’) made a request to the competent authority of Ireland to place bovine milk basic whey protein isolate obtained from skimmed bovine milk through a series of purification steps, on the Union market as a novel food ingredient within the meaning of point (e) of Article 1(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council (3). The application seeks to have bovine milk basic whey protein isolate used in infant and follow-on formulae, in total diet replacement foods for weight control and in foods for special medical purposes, and in food supplements.

                     (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 bovine milk basic whey protein isolate 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 27 June 2017, the competent authority of Ireland issued its initial assessment report. In that report, it concluded that bovine milk basic whey protein isolate meets the criteria for a novel food ingredient set out in Article 3(1) of Regulation (EC) No 258/97.

                     (8)

                     On 4 July 2017, 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 of bovine milk basic whey protein isolate for infants, and the toxicological relevance of the results in a 6-week developmental toxicity study in juvenile rats (4).

                     (9)

                     In view of the objections raised by the other Member States, the Commission consulted the European Food Safety Authority (‘the Authority’) on 11 December 2017, asking it to carry out an additional assessment for bovine milk basic whey protein isolate as a novel food ingredient in accordance with Regulation (EC) No 258/97.

                     (10)

                     In a subsequent application submitted on 3 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 two human clinical studies with a bovine milk basic whey protein isolate (5) (6), an in vitro bacterial reverse mutation assay (7), an in vitro mammalian cell micronucleus test (8), a 90-day oral toxicity study in rats (9), a 6-week developmental toxicity study in juvenile rats, and the electrophoresis analysis of bovine milk basic whey protein isolate (10).

                     (11)

                     On 27 June 2018, the Authority adopted ‘Scientific Opinion on the safety of bovine milk basic whey protein isolate as a novel food pursuant to Regulation (EU) 2015/2283’ (11). That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (12)

                     That opinion gives sufficient grounds to establish that bovine milk basic whey protein isolate, in the proposed uses and use levels when used as an ingredient in infant and follow-on formulae, in total diet replacement foods for weight control, in foods for special medical purposes, and in food supplements, complies with Article 12(1) of Regulation (EU) 2015/2283.

                     (13)

                     In its opinion on bovine milk basic whey protein isolate, the Authority considered that the data from the 90-day oral toxicity study in rats served as a basis to establish a reference point and to assess whether the margin of exposure in relation to the proposed maximum intake of the novel food by humans is sufficient. Therefore, it is considered that the conclusions on the safety of bovine milk basic whey protein isolate could not have been reached without the data from the report of this study.

                     (14)

                     Following 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 90-day oral toxicity in rats study report, and to clarify their claim to an exclusive right of reference to this study, as referred to in points (a) and (b) of Article 26(2) of Regulation (EU) 2015/2283.

                     (15)

                     The Applicant also declared to hold proprietary and exclusive rights of reference to the study under national law at the time the application was submitted, and that therefore third parties could not lawfully access or use this study. The Commission has assessed all the information provided by the Applicant and considers 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 90-day oral toxicity study in rats contained in the Applicant's file, and without which the novel food could not have been assessed by the Authority, 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 90-day oral toxicity study in rats 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)

                     As the source of the novel food comes from milk, which is listed in Annex II to Regulation (EU) No 1169/2011 of the European Parliament and of the Council (12) as one of a number of substances or products which cause allergies or intolerances, foods and food supplements containing bovine milk basic whey protein isolate should be appropriately labelled following the requirements of Article 21 of that Regulation.

                     (19)

                     Directive 2002/46/EC of the European Parliament and of the Council (13) lays down requirements on food supplements. The use of bovine milk basic whey protein isolate should be authorised without prejudice to that Directive.

                     (20)

                     Regulation (EU) No 609/2013 of the European Parliament and of the Council (14) lays down requirements on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control. The use of bovine milk basic whey protein isolate should be authorised without prejudice to that Regulation.

                     (21)

                     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.   Bovine milk basic whey protein isolate 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: Armor Protéines S.A.S.

                           —

                           Address: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France;

                     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 Armor Protéines S.A.S.

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

               4.   The authorisation provided for in this Article shall be without prejudice to the provisions of Regulation (EU) No 1169/2011, to the provisions of Directive 2002/46/EC, and to the provisions of Regulation (EU) No 609/2013.

            Article 2
            The study 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 fulfilling the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283, 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 Armor Protéines S.A.S.

            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, 30 October 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)  Spézia (2012).

            (5)  Armor Protéines (2013).

            (6)  Schmitt & Mireaux (2008).

            (7)  Sire, G. (2012a).

            (8)  Sire, G. (2012b).

            (9)  Silvano (2012).

            (10)  Armor Protéines (2017).

            (11)  EFSA Journal 2018; 16(7):5360.

            (12)  Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18).

            (13)  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).

            (14)  Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009, (OJ L 181, 29.6.2013, p. 35).

            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

                                    ‘Bovine milk basic whey protein isolate

                                       Specified food category

                                       Maximum levels

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”.
                                    Food supplements containing bovine milk basic whey protein isolate shall bear the following statement:

                                       “This food supplement should not be consumed by children/adolescents under the age of three/eighteen (*) years”

                                                (*)

                                                Depending on the age group the food supplement is intended for.

                                    Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
                                    Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. 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 Armor Protéines S.A.S..
                                    End date of the data protection: 20 November 2023.’

                                    Infant formulae as defined in Regulation (EU) No 609/2013

                                    30 mg/100 g (powder)
                                    3,9 mg/100 mL (reconstituted)

                                    Follow-on formulae as defined in Regulation (EU) No 609/2013

                                    30 mg/100 g (powder)
                                    4,2 mg/100 mL (reconstituted)

                                    Total diet replacement foods for weight control as defined by Regulation (EU) No 609/2013

                                    300 mg/day

                                    Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                                    58 mg/day for young children
                                    380 mg/day for children and adolescents from 3 to 18 years of age
                                    610 mg/day for adults

                                    Food Supplements as defined in Directive 2002/46/EC

                                    58 mg/day for young children
                                    250 mg/day for children and adolescents from 3 to 18 years of age
                                    610 mg/day for adults

                        (3)

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

                                    Authorised Novel Food

                                    Specification

                                    ‘Bovine milk basic whey protein isolate

                                       Description

                                    Bovine milk basic whey protein isolate is a yellowish grey powder obtained from bovine skimmed milk via a series of isolation and purification steps.

                                       Characteristics/Composition

                                    Total protein (w/weight of product): ≥ 90 %
                                    Lactoferrin (w/weight of product): 25-75 %
                                    Lactoperoxidase (w/weight of product): 10-40 %
                                    Other proteins (w/weight of product): ≤ 30 %
                                    TGF-β2: 12-18 mg/100 g
                                    Moisture: ≤ 6,0 %
                                    pH (5 % solution w/v): 5,5 – 7,6
                                    Lactose: ≤ 3,0 %
                                    Fat: ≤ 4,5 %
                                    Ash: ≤ 3,5 %
                                    Iron: ≤ 25 mg/100 g

                                       Heavy Metals

                                    Lead: < 0,1 mg/kg
                                    Cadmium: < 0,2 mg/kg
                                    Mercury: < 0,6 mg/kg
                                    Arsenic: < 0,1 mg/kg

                                       Microbiological criteria:

                                    Aerobic mesophilic count: ≤ 10 000  CFU/g

                                       Enterobacteriaceae: ≤ 10 CFU/g

                                       Escherichia coli: Negative/g
                                    Coagulase positive Staphylococci: Negative/g

                                       Salmonella: Negative/25 g

                                       Listeria: Negative/25 g

                                       Cronobacter spp.: Negative/25 g
                                    Moulds: ≤ 50 CFU/g
                                    Yeasts: ≤ 50 CFU/g
                                    CFU: Colony Forming Units’


title: Commission Implementing Regulation (EU) 2018/1633 of 30 October 2018 authorising the placing on the market of refined shrimp peptide concentrate 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:
                  31.10.2018

                  EN

                  Official Journal of the European Union

                  L 272/29

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1633
         of 30 October 2018
         authorising the placing on the market of refined shrimp peptide concentrate as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

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

                     (2)

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

                     (3)

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

                     (4)

                     On 22 December 2016, the company Marealis AS (‘the Applicant’) made a request to the competent authority of Finland to place refined shrimp peptide concentrate produced from the enzymatic hydrolysis of Northern shrimp (Pandalus borealis) shells and heads, on the Union market as a novel food ingredient within the meaning of point (e) of Article 1(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council (3). The application seeks to have refined shrimp peptide concentrate used in food supplements for the general adult population.

                     (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 refined shrimp peptide concentrate 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 March 2017, the competent authority of Finland issued its initial assessment report. In that report, it concluded that refined shrimp peptide concentrate meets the criteria for a novel food ingredient set out in Article 3(1) of Regulation (EC) No 258/97.

                     (8)

                     On 13 March 2017, 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 of refined shrimp peptide concentrate for hypo-, normo-, and hyper-tensive consumers due to its putative antihypertensive effects, its potential side effects related to its postulated inhibition of the angiotensin converting enzyme (ACE) and potential cardiac effects, and its potential interactions with medicines used in the treatment of blood pressure disorders.

                     (9)

                     In view of the objections raised by the other Member States, the Commission consulted the European Food Safety Authority (‘the Authority’) on 21 September 2017, asking it to carry out an additional assessment for refined shrimp peptide concentrate as novel food ingredient in accordance with Regulation (EC) No 258/97.

                     (10)

                     On 2 February 2018, the Applicant made a request to the Commission for the protection of proprietary data for a number of studies submitted in support of the application namely, a de novo peptide synthesis study (4), the analytical report of the ACE inhibitory effects study (5), an acute oral toxicity study (6), an in vitro bacterial reverse mutation assay (7), a 90-day oral toxicity study (8), an assessment study of the antihypertensive effects and safety of the refined shrimp peptide concentrate in healthy humans with mild or moderate hypertension (9), and a double-blind, placebo-controlled, parallel study on the assessment of anti-hypertensive effect and safety of a the refined shrimp peptide concentrate in dietary supplements in healthy humans with mild or moderate hypertension (10). This request was reiterated by the Applicant in a subsequent application submitted on 29 March 2018.

                     (11)

                     On 18 April 2018, the Authority adopted ‘Scientific Opinion on the safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283’ (11). That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (12)

                     That opinion gives sufficient grounds to establish that refined shrimp peptide concentrate, 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.

                     (13)

                     In its opinion, the Authority considered that the data from the 90-day oral toxicity study served as a basis to assess the toxicity profile of refined shrimp peptide concentrate and to establish the related No Observed Adverse Effect Level (NOAEL). The data from the assessment study of the antihypertensive effects and safety of the refined shrimp peptide concentrate in healthy humans with mild or moderate hypertension, and the data from the double-blind, placebo-controlled, parallel study on the assessment of anti-hypertensive effect and safety of a the refined shrimp peptide concentrate dietary supplement in healthy humans with mild or moderate hypertension, served as the basis to establish the safety of the novel food for this category of consumers. Therefore, it is considered that the conclusions on the safety of refined shrimp peptide concentrate, could not have been reached without the data from the unpublished reports of these studies.

                     (14)

                     Following 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, and to clarify their claim to an exclusive right of reference to those studies, as referred to in points (a) and (b) of Article 26(2) of Regulation (EU) 2015/2283. The Applicant also declared to hold proprietary and exclusive rights of reference to the studies under national law at the time the application was submitted, and that therefore third parties could not lawfully access or use those studies. The Commission has assessed all the information provided by the Applicant and considers that the Applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283.

                     (15)

                     Accordingly, as provided for under Article 26(2) of Regulation (EU) 2015/2283, the 90-day oral toxicity study, the assessment study of the antihypertensive effects and safety of the refined shrimp peptide concentrate in healthy humans with mild or moderate hypertension, and the double-blind, placebo-controlled, parallel study on the assessment of anti-hypertensive effect and safety of a the refined shrimp peptide concentrate dietary supplement in healthy humans with mild or moderate hypertension, contained in the Applicant's file and without which the novel food could not have been assessed by the Authority, 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.

                     (16)

                     However, restricting the authorisation of this novel food and of the reference to the 90-day oral toxicity study, to the assessment study of the antihypertensive effects and safety of the refined shrimp peptide concentrate in healthy humans with mild or moderate hypertension, and to the double-blind, placebo-controlled, parallel study on the assessment of anti-hypertensive effect and safety of a the refined shrimp peptide concentrate dietary supplement in healthy humans with mild or moderate hypertension, 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.

                     (17)

                     As the source of the novel food comes from crustaceans, and may contain traces of fish, of other crustaceans, and of molluscs, which are listed in Annex II to Regulation (EU) No 1169/2011 of the European Parliament and of the Council (12) as substances or products which cause allergies or intolerances, food supplements containing refined shrimp peptide concentrate should be appropriately labelled following the requirements of Article 21 of that Regulation.

                     (18)

                     Directive 2002/46/EC of the European Parliament and of the Council (13) lays down requirements on food supplements. The use of refined shrimp peptide concentrate should be authorised without prejudice to that Directive.

                     (19)

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

               HAS ADOPTED THIS REGULATION:

            Article 1

               1.   Refined shrimp peptide concentrate 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: Marealis AS;

                           —

                           Address: Stortorget 1, Kystens Hus, 2nd floor, N-9008 Tromsø Postal address: P.O. Box 1065, 9261 Tromsø, Norway;

                     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 Marealis AS.

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

               4.   The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC and to the provisions of Regulation (EU) No 1169/2011.

            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 fulfilling the requirements laid down in Article 26(2) of Regulation (EC) No 2015/2283, 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 Marealis AS.

            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, 30 October 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)  Marealis A.S., 2016.

            (5)  Marealis A.S., 2009-2016.

            (6)  Marealis A.S., 2010.

            (7)  Marealis A.S., 2011.

            (8)  Marealis A.S., 2011.

            (9)  Sarkkinen, E., et al. 2013.

            (10)  Pelipyagina, T., 2016.

            (11)  EFSA Journal 2018; 16(5):5267.

            (12)  Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18).

            (13)  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

                                    ‘Refined shrimp peptide concentrate

                                       Specified food category

                                       Maximum levels

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘refined shrimp peptide concentrate’.

                                    Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
                                    Applicant: Marealis AS., Stortorget 1, Kystens Hus, 2nd floor, N-9008 Tromsø Postal address: P.O. Box 1065, 9261 Tromsø, Norway. During the period of data protection the novel food refined shrimp peptide concentrate is authorised for placing on the market within the Union only by Marealis AS 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 Marealis AS.
                                    End date of the data protection: 20 November 2023.’

                                    Food Supplements as defined in Directive 2002/46/EC for the adult population

                                    1 200  mg/day

                        (3)

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

                                    Authorised Novel Food

                                    Specification

                                    ‘Refined shrimp peptide concentrate

                                       Description

                                    Refined shrimp peptide concentrate is a peptide mixture obtained from northern shrimp (Pandalus borealis) shells and heads via a series of purification steps following enzymatic proteolysis using a protease from Bacillus licheniformis and/or Bacillus amyloliquefaciens.

                                       Characteristics/Composition

                                    Total Dry matter (%): ≥ 95,0 %
                                    Peptides (w/weight dry matter): ≥ 87,0 % of which peptides with molecular weight < 2 kDa: ≥ 99,9 %
                                    Fat (w/w): ≤ 1,0 %
                                    Carbohydrates (w/w): ≤ 1,0 %
                                    Ash (w/w): ≤ 15,0 %
                                    Calcium: ≤ 2,0 %
                                    Potassium: ≤ 0,15 %
                                    Sodium: ≤ 3,5 %

                                       Heavy Metals

                                    Arsenic (inorganic): ≤ 0,22 mg/kg
                                    Arsenic (organic): ≤ 51,0 mg/kg
                                    Cadmium: ≤ 0,09 mg/kg
                                    Lead: ≤ 0,18 mg/kg
                                    Total mercury: ≤ 0,03 mg/kg

                                       Microbiological criteria:

                                    Total viable cell count: ≤ 20 000  CFU/g

                                       Salmonella: ND/25g

                                       Listeria monocytogenes: ND/25g

                                       Escherichia coli: ≤ 20 CFU/g
                                    Coagulase positive Staphylococcus aureus: ≤ 200 CFU/g

                                       Pseudomonas aeruginosa: ND/25g
                                    Mould/yeast: ≤ 20 CFU/g
                                    CFU: Colony Forming Units
                                    ND: Not Detectable’