title: Commission Implementing Regulation (EU) 2018/183 of 7 February 2018 concerning the denial of authorisation of formaldehyde as a feed additive belonging to the functional groups of preservatives and hygiene condition enhancers (Text with EEA relevance. )

text:
               8.2.2018

               EN

               Official Journal of the European Union

               L 34/6

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/183
   of 7 February 2018
   concerning the denial of authorisation of formaldehyde as a feed additive belonging to the functional groups of preservatives and hygiene condition enhancers
   (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 or denying such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

               (2)

               Formaldehyde was authorised for an unlimited period in accordance with Directive 70/524/EEC as a feed additive belonging to the group of preservatives for pigs up to 6 months of age for use in skimmed milk by Commission Directive 83/466/EEC (3). That product was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

               (3)

               Formaldehyde (EC No 200-001-8, CAS No 50-00-0) was included in the list, established by Commission Regulation (EC) No 1451/2007 (4), of active substances to be assessed with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (5). However, Regulation (EU) No 528/2012 of the European Parliament and of the Council (6), replacing Directive 98/8/EC, does not cover products used for the preservation of feed by controlling harmful organisms, in particular for reducing the contamination of feed with Salmonella, considering that such products fall within the scope of Regulation (EC) No 1831/2003. Since 1 July 2015, in accordance with Commission Decision 2013/204/EU (7), biocidal products for use as feed preservatives and containing formaldehyde are not to be placed on the market. That date was set with the aim to provide the time necessary to allow the transition from the biocidal products regulatory regime to the feed additives regime under Regulation (EC) No 1831/2003.

               (4)

               In accordance with Article 7 of Regulation (EC) No 1831/2003, two applications were submitted for the authorisation of a preparation of formaldehyde as a feed additive for all animal species, requesting the additive to be classified in the additive category ‘technological additives’ and in the functional group ‘preservatives’. Both applications include the use in skimmed milk for pigs up to the age of 6 months, as an existing product, in accordance with Article 10(2) of Regulation (EC) No 1831/2003. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

               (5)

               In addition, in accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of formaldehyde as a feed additive for pigs and poultry, requesting the additive to be classified in the additive category ‘technological additives’ and in the functional group ‘hygiene condition enhancers’. This application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

               (6)

               The European Food Safety Authority (‘the Authority’) concluded in its two opinions of 28 January 2014 (8) and in its opinion of 1 July 2014 (9) that, as regards the target species, the preparation of formaldehyde would be safe at specific concentration levels for chickens for fattening, laying hens, Japanese quail and piglets (weaned) but that no safe level for all animal species and categories, including all poultry and pigs, could be determined. In addition, a formaldehyde concentration level that would be safe for reproduction for the target species could not be derived from the available studies. The Authority also concluded that the preparation of formaldehyde had the potential to be effective as preservative and, as hygiene condition enhancer, in reducing microbial growth in feed contaminated with Salmonella. In those three opinions, the Authority further concluded that formaldehyde raised concerns for the safety of the users. Formaldehyde is a toxic substance, a strong irritant, a potent skin and respiratory sensitiser (including occupational asthma) and causes eye damage. In its opinions, the Authority mentioned that, while local irritation is expected to strongly promote carcinogenesis, lower local concentrations of formaldehyde are known to produce DNA adducts and that therefore it deemed it prudent not to consider the exposure to non-irritant concentration as totally risk-free. The Authority concluded that moreover, on the basis of the present knowledge, a causal association between formaldehyde exposure and leukaemia could not be ruled out. The Authority concluded that, as regards the requested use in feed of the preparation of formaldehyde, no safe level of exposure of the skin, eyes or the respiratory system to formaldehyde could be identified. Therefore, the Authority recommended that measures should be taken to ensure that the respiratory tract, as well as the skin and eyes, of any person handling the product are not exposed to any dust, mist or vapour generated by the use of formaldehyde. In addition, the Authority recommended that consideration should be given to whether the strict protection measures, once established, would effectively protect users. The Authority 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.

               (7)

               Formaldehyde is classified as carcinogenic (category 1B) by inhalation and germ cell mutagenic (category 2) under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (10).

               (8)

               In the framework of Union legislation on health and safety at work, occupational exposure limits are being developed for formaldehyde. The Scientific Committee on Occupational Exposure Limits established by Commission Decision 2014/113/EU (11) has, in its Recommendation of 30 June 2016 (12), pronounced itself on a limit value for formaldehyde based on a mode-of-action assessment, which was then considered by the tripartite Advisory Committee on Safety and Health at Work (13) in accordance with the procedures for establishing occupational exposure limits.

               (9)

               In accordance with Article 9 of Regulation (EC) No 1831/2003, the measure on the authorisation of an additive is to take into account the requirements of paragraphs 2 and 3 of Article 5 of that Regulation, as well as Community law and other legitimate factors relevant to the matter under consideration. The risk management decision concerning the authorisation of formaldehyde as a feed additive should therefore be based on all the information available regarding the risks at stake, in particular on the one hand the risks posed by the handling of formaldehyde to users, in particular workers, and on the other hand the risks to animals or to consumers of the animal products concerned that could derive from not using formaldehyde as a feed additive.

               (10)

               In accordance with Union legislation on health and safety at work, and in particular with Article 4 of Directive 2004/37/EC of the European Parliament and of the Council (14), the employer is to reduce the use of a carcinogen or mutagen at the place of work, in particular by replacing it, in so far as is technically possible, by a substance, mixture or process which, under its conditions of use, is not dangerous or is less dangerous for workers' health or safety.

               (11)

               Due to the serious risks for users posed by the handling of formaldehyde, such approach based on replacement is also appropriate for that additive, taking into account the objective of ensuring a high level of protection of human health and users' interests pursued by Regulation (EC) No 1831/2003 and the precautionary principle provided for in Regulation (EC) No 178/2002 of the European Parliament and of the Council (15).

               (12)

               As regards possible alternative products to formaldehyde as an additive belonging to the functional group of preservatives, a series of additives are currently authorised in the Union under the same functional group.

               (13)

               As regards possible alternative products to formaldehyde as an additive belonging to the functional group of hygiene condition enhancers (16), research is currently being conducted to develop additives which would prove both safe and efficacious in reducing microbiological contamination in feed. An additive has already been authorised (17) under that functional group and is therefore considered as an alternative, although with a different mechanism of action, in order to reduce the number of bacterial pathogens, including Salmonella spp., in feed, without causing the concerns over users' safety raised by the use of formaldehyde. Several applications for authorisation of other additives under that functional group have been submitted and are being assessed in accordance with Regulation (EC) No 1831/2003. In addition, other authorised feed additives may, as zootechnical additives, improve the quality of animal products through a reduction of contamination with enteropathogens such as Salmonella spp.

               (14)

               In addition to the possibility of using alternative products to formaldehyde for the envisaged purposes in feed, the implementation of the hygiene requirements and good practices along the feed chain, as provided for in Regulation (EC) No 183/2005 of the European Parliament and of the Council (18), contributes to the safety and quality of feed through a preventive approach. In particular, specific hygiene measures are provided for under that framework for the control, prevention and treatment of feed contaminated with Salmonella.

               (15)

               It follows from the above elements that, taking into account the adverse effects of formaldehyde on the health of users handling the substance, in conjunction with the application of the precautionary principle in the protection of workers' health and with the fact that some products and measures, which do not present the same human safety concerns, are available as alternatives to the envisaged uses of formaldehyde in feed, the advantages of formaldehyde do not compensate the health risks. Therefore, the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are not satisfied and accordingly, the authorisation of formaldehyde as a feed additive for use as preservative and hygiene condition enhancer should be denied.

               (16)

               Since further use of formaldehyde may cause a risk to human health, the feed additive belonging to the functional group of ‘preservatives’ for use in skimmed milk for pigs up to the age of 6 months, and premixtures containing it, should be withdrawn from the market as soon as possible. For practical reasons however, a limited period should be allowed for the withdrawal from the market of the existing stocks of those products in order to enable operators to comply properly with the withdrawal obligation. As a result, a limited period should also be granted for the withdrawal from the market of skimmed milk containing the additive or the premixtures, and compound feed containing such skimmed milk, in order to take into account the use of those products in the feed chain.

               (17)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Denial of authorisation
   The authorisation of formaldehyde as an additive in animal nutrition, belonging to the additive category ‘technological additives’ and to the functional groups ‘preservatives’ and ‘hygiene condition enhancers’, is denied.
   Article 2
   Withdrawal from the market
   1.   Existing stocks of formaldehyde as an additive belonging to the additive category ‘technological additives’ and to the functional group ‘preservatives’ for use in skimmed milk for pigs up to the age of 6 months, and of premixtures containing that additive, shall be withdrawn from the market as soon as possible and at the latest by 28 May 2018.
   2.   Skimmed milk containing the additive or skimmed milk containing the premixtures referred to in paragraph 1, and compound feed containing such skimmed milk, which have been produced before 28 May 2018 shall be withdrawn from the market as soon as possible and at the latest by 28 August 2018.
   Article 3
   Entry into force
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 7 February 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

      (3)  Forty-third Commission Directive 83/466/EEC of 28 July 1983 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs (OJ L 255, 15.9.1983, p. 28). The chemical description of the additive was made more precise by Commission Directive 85/429/EEC of 8 July 1985 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs (OJ L 245, 12.9.1985, p. 1).

      (4)  Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).

      (5)  Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).

      (6)  Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market of biocidal products (OJ L 167, 27.6.2012, p. 1).

      (7)  Commission Decision 2013/204/EU of 25 April 2013 concerning the non-inclusion of formaldehyde for product-type 20 in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 117, 27.4.2013, p. 18).

      (8)  EFSA Journal 2014;12(2):3561 and EFSA Journal 2014;12(2)3562.

      (9)  EFSA Journal 2014;12(7):3790.

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

      (11)  Commission Decision 2014/113/EU of 3 March 2014 on setting up a Scientific Committee on Occupational Exposure Limits for Chemical Agents and repealing Decision 95/320/EC (OJ L 62, 4.3.2014, p. 18).

      (12)  SCOEL/REC/125. Available at the following address: https://publications.europa.eu/en/publication-detail/-/publication/7a7ae0c9-c03d-11e6-a6db-01aa75ed71a1

      (13)  The Advisory Committee on Safety and Health at Work was established by Council Decision 2003/C 218/01 of 22 July 2003 setting up an Advisory Committee on Safety and Health at Work (OJ C 218, 13.9.2003, p. 1).

      (14)  Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p. 50).

      (15)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

      (16)  This functional group has been established as a result of technological and scientific development by Commission Regulation (EU) 2015/2294 of 9 December 2015 amending Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the establishment of a new functional group of feed additives (OJ L 324, 10.12.2015, p. 3).

      (17)  Commission Implementing Regulation (EU) 2017/940 of 1 June 2017 concerning the authorisation of formic acid as a feed additive for all animal species (OJ L 142, 2.6.2017, p. 40).

      (18)  Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1).


title: Commission Implementing Regulation (EU) 2018/185 of 7 February 2018 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance penflufen (Text with EEA relevance. )

text:
                  8.2.2018

                  EN

                  Official Journal of the European Union

                  L 34/13

            COMMISSION IMPLEMENTING REGULATION (EU) 2018/185
      of 7 February 2018
      amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance penflufen
      (Text with EEA relevance)
      THE EUROPEAN COMMISSION,
      Having regard to the Treaty on the Functioning of the European Union,
      Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2)(c) thereof,
      Whereas:

                  (1)

                  Commission Implementing Regulation (EU) No 1031/2013 (2) approved the active substance penflufen and included it in Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011 (3). The approval was restricted to uses to treat seed potato tubers before or during planting limited to one sowing of seeds treated with penflufen every third year in the same field.

                  (2)

                  In accordance with Article 7(1) of Regulation (EC) No 1107/2009, on 13 May 2014 the producer of the active substance Bayer CropScience AG submitted an application to the designated rapporteur Member State, the United Kingdom, seeking an amendment to the conditions of approval of penflufen in order to allow its use on other seeds. Uses on barley and wheat were described in the dossier. In accordance with Article 9(3) of that Regulation, United Kingdom notified the applicant, the other Member States, the European Food Safety Authority (‘the Authority’) and the Commission on 16 June 2014 that the application was admissible.

                  (3)

                  The designated rapporteur Member State assessed the new use of the active substance penflufen in relation to potential effects on human and animal health and the environment in accordance with the provisions of Article 4 of Regulation (EC) No 1107/2009, and submitted a draft assessment report to the Commission and to the Authority on 5 August 2015. In accordance with Article 12(3) of that Regulation additional information was requested from the applicant. The United Kingdom evaluated the additional information and submitted an updated draft assessment report to the Commission and to the Authority on 8 July 2016.

                  (4)

                  On 3 November 2016 the Authority communicated to the Commission its conclusion (4) on whether the new uses of the active substance penflufen can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft addendum to the review report for penflufen and a draft Regulation to the Standing Committee on Plants, Animals, Food and Feed on 23 January 2017.

                  (5)

                  The applicant was invited to submit comments on the addendum to the review report.

                  (6)

                  It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance that, when the plant protection product is used to treat seeds or other propagating materials which are sown or planted, the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to withdraw the restriction for the use of penflufen for seed potato tubers only and allow its use also for other seeds or other propagating materials.

                  (7)

                  In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in light of current scientific and technical knowledge, it is necessary and appropriate to amend the conditions of approval while keeping certain conditions and restrictions and to require the applicant to provide confirmatory information provided in the first approval.

                  (8)

                  Implementing Regulation (EU) No 1031/2013 required the applicant to submit confirmatory information regarding the long-term risk to birds within two years after the entry into force of that Regulation. As the applicant submitted that data as part of the dossier seeking the amendment of the conditions of approval of the active substance penflufen the requirement is considered as fulfilled. Member States should take advantage of these new pieces of information and check the national authorisations for products containing penflufen, where relevant.

                  (9)

                  Implementing Regulation (EU) No 1031/2013 also required that information regarding the specification of the technical material as commercially manufactured to be submitted to the Commission. As that data were evaluated by the United Kingdom as part of the procedure to amend the conditions of approval of the active substance penflufen the requirement is considered as fulfilled.

                  (10)

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

                  (11)

                  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
      Amendment to Implementing Regulation (EU) No 540/2011
      The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
      Article 2
      Entry into force
      This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

         This Regulation shall be binding in its entirety and directly applicable in all Member States.
         Done at Brussels, 7 February 2018.

               For the Commission

               The President

            Jean-Claude JUNCKER

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

         (2)  Commission Implementing Regulation (EU) No 1031/2013 of 24 October 2013 approving the active substance penflufen, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 283, 25.10.2013, p. 17).

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

         (4)  EFSA Journal 2016;14(11):4604. Available online: www.efsa.europa.eu

         ANNEX
         The column ‘Specific provisions’ of row 55, penflufen, of Part B of the Annex to Implementing Regulation (EU) No 540/2011 is replaced by the following:

            ‘PART A
            Only uses to treat seeds or other propagating materials before or during sowing or planting, may be authorised, limited to one application every third year on the same field.
            PART B
            For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on penflufen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 and of the addendum to the review report on penflufen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 13 December 2017 shall be taken into account.
            In this overall assessment Member States shall pay particular attention to:

                        (a)

                        the protection of operators;

                        (b)

                        the long-term risk to birds;

                        (c)

                        the protection of groundwater, when the substance is applied to regions with vulnerable soil and/or climatic conditions;

                        (d)

                        to the residues in surface water abducted for drinking water purposes, in or from areas where products containing penflufen are used.

                  Conditions of use shall include risk mitigation measures, where appropriate.
            The applicant shall submit confirmatory information as regards the relevance of the metabolite M01 (penflufen-3-hydroxy-butyl) for groundwater if penflufen is classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (*1) as “carcinogen category 2”. That information shall be submitted to the Commission, the Member States and the Authority within 6 months from the notification of the classification decision concerning that substance.


title: Commission Implementing Regulation (EU) 2018/200 of 9 February 2018 amending Council Regulation (EU) 2016/44 concerning restrictive measures in view of the situation in Libya

text:
               10.2.2018

               EN

               Official Journal of the European Union

               L 38/11

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/200
   of 9 February 2018
   amending Council Regulation (EU) 2016/44 concerning restrictive measures in view of the situation in Libya
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Decision (CFSP) 2015/1333 of 31 July 2015 concerning restrictive measures in view of the situation in Libya, and repealing Decision 2011/137/CFSP (1),
   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 (2), and in particular Article 20(b) thereof,
   Whereas:

               (1)

               Annex V to Regulation (EU) 2016/44 lists vessels designated by the United Nations Sanctions Committee in accordance with paragraph 11 of United Nations Security Council Resolution (UNSCR) 2146 (2014). Those vessels are subject to a number of prohibitions under Regulation (EU) 2016/44, including the prohibition to load, transport or discharge crude oil from Libya and to access ports in the territory of the Union.

               (2)

               On 2 February 2018, the United Nations Security Council Committee amended the listing of vessel CAPRICORN subject to restrictive measures. Therefore, Annex V to Regulation (EU) 2016/44 should be amended accordingly.

               (3)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex V 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 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, 9 February 2018.

            For the Commission,

            On behalf of the President,

            Head of the Service for Foreign Policy Instruments

      (1)  OJ L 206, 1.8.2015, p. 34.

      (2)  OJ L 12, 19.1.2016, p. 1.

      ANNEX
      Annex V to Regulation (EU) 2016/44 is amended as follows:
      The entry:

                     ‘1.

                     Name: CAPRICORN
                     Listed pursuant to paragraphs 10(a) and 10(b) of resolution 2146 (2014), as extended and modified by paragraph 2 of resolution 2362 (2017) (prohibition to load, transport or discharge; prohibition to enter ports). Pursuant to paragraph 11 of resolution 2146, this designation was renewed by the Committee on 18 January 2018 and is valid until 17 April 2018, unless terminated earlier by the Committee pursuant to paragraph 12 of resolution 2146. Flag State: unknown.

                        Additional information

                     Listed on 21 July 2017. IMO: 8900878. As of 21 September 2017, the vessel was located in international waters off the United Arab Emirates.’,

      is replaced by the following:

                     ‘1.

                     Name: NADINE
                     Listed pursuant to paragraphs 10(a) and 10(b) of resolution 2146 (2014), as extended and modified by paragraph 2 of resolution 2362 (2017) (prohibition to load, transport or discharge; prohibition to enter ports). Pursuant to paragraph 11 of resolution 2146, this designation was renewed by the Committee on 18 January 2018 and is valid until 17 April 2018, unless terminated earlier by the Committee pursuant to paragraph 12 of resolution 2146. Flag State: Palau.

                        Additional information

                     Listed on 21 July 2017. IMO: 8900878. As of 19 January 2018, the vessel was located near the coast of Muscat, Oman, outside its territorial waters.’


title: Council Implementing Regulation (EU) 2018/197 of 9 February 2018 implementing Article 9 of Regulation (EC) No 1183/2005 imposing certain specific restrictive measures directed against persons acting in violation of the arms embargo with regard to the Democratic Republic of the Congo

text:
               10.2.2018

               EN

               Official Journal of the European Union

               L 38/2

         COUNCIL IMPLEMENTING REGULATION (EU) 2018/197
   of 9 February 2018
   implementing Article 9 of Regulation (EC) No 1183/2005 imposing certain specific restrictive measures directed against persons acting in violation of the arms embargo with regard to the Democratic Republic of the Congo
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1183/2005 of 18 July 2005 imposing certain specific restrictive measures directed against persons acting in violation of the arms embargo with regard to the Democratic Republic of Congo (1), and in particular Article 9,
   Having regard to the proposal of the High Representative of the Union for Foreign Affairs and Security Policy,
   Whereas:

               (1)

               On 18 July 2005, the Council adopted Regulation (EC) No 1183/2005.

               (2)

               On 1 February 2018, the United Nations Security Council Committee, established pursuant to United Nations Security Council Resolution 1533 (2004), added four persons to the list of persons and entities subject to restrictive measures. Those persons should therefore be added to Annex I to Regulation (EC) No 1183/2005. Since two of those persons were already designated under Annex Ia to that Regulation, they should be removed from Annex Ia to that Regulation to be now designated under Annex I to that Regulation.

               (3)

               Annexes I and Ia to Regulation (EC) No 1183/2005 should therefore be amended accordingly,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex I to Regulation (EC) No 1183/2005 is hereby amended as set out in Annex I to this Regulation.
   Article 2
   Annex Ia to Regulation (EC) No 1183/2005 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, 9 February 2018.

            For the Council

            The President

         E. ZAHARIEVA

      (1)  OJ L 193, 23.7.2005, p. 1.

      ANNEX I
      The persons listed below shall be added to the list set out in Part (a) of Annex I to Regulation (EC) No 1183/2005:

                     ‘32.

                     Muhindo Akili Mundos (alias: (a) Charles Muhindo Akili Mundos; (b) Akili Muhindo; (c) Muhindo Mundos)

               Designation: (a) DRC Armed Forces (FARDC) General, Commander of the 31st Brigade; (b) FARDC Brigadier General
         Date of birth: 10 November 1972
         Place of birth: Democratic Republic of the Congo
         Nationality: Democratic Republic of the Congo
         Date of UN designation: 1 February 2018
         Other information: Muhindo Akili Mundos is an FARDC General, Commander of the 31st Brigade. He was appointed commander of the FARDC's Operational Sector in the areas of Beni and Lubero, including Operation Sukola I against the Allied Democratic Forces (ADF) in September 2014. He remained in that position until June 2015. He is also a threat to the peace, stability and security of the DRC under UNSCR 2293 paragraph 7(e).
         Additional information from the narrative summary of reasons for listing provided by the Sanctions Committee:
         Reason for listing:
         Muhindo Akili Mundos was listed on 1 February 2018 pursuant to criteria set out in resolution paragraph 7(e) of resolution 2293 (2016) as reaffirmed in resolution 2360 (2017).
         Additional Information:
         Muhindo Akili Mundos was the Congolese army commander responsible for military operations against the ADF during the “Sukola I” operation from August 2014 to June 2015. The FARDC unit under Mundos' command failed to intervene to prevent human rights abuses by the ADF, including attacks targeting civilians. Mundos recruited and equipped former fighters from local armed groups to participate in extra-judicial killings and massacres by the ADF.
         While he was commander of the FARDC's Sukola I operation, Mundos also commanded and provided support to a faction of an ADF sub-group known as the ADF-Mwalika. Under Mundos' command, the ADF-Mwalika committed attacks against civilians. FARDC fighters under Mundos' command provided additional support to the ADF-Mwalika during these operations.

                     33.

                     Guidon Shimiray Mwissa

               Date of birth: 13 March 1980
         Place of birth: Kigoma, Walikale, Democratic Republic of the Congo
         Date of UN designation: 1 February 2018
         Other information: Graduated secondary school humanités sociales in Mpofi; joined the armed group commanded by She Kasikila at the age of 16; integrated the FARDC with Kasikila, becoming his battalion S3; injured in 2007, thereafter joining Mai Mai Simba under then-commander “Mando”; participated in the creation of the NDC in 2008, becoming the deputy commander in charge of the Aigle Lemabé Brigade. He is also a threat to the peace, stability and security of the DRC under UNSCR 2293 paragraph 7(g).
         Additional information from the narrative summary of reasons for listing provided by the Sanctions Committee:
         Reason for listing:
         Guidon Shimiray Mwissa was listed on 1 February 2018 pursuant to criteria set out in resolution paragraph 7(g) of resolution 2293 (2016) as reaffirmed in resolution 2360 (2017).
         Additional Information:
         “General” Guidon Shimiray Mwissa broke away from the Nduma defense du Congo (NDC) and created his own group, NDC-R in 2014.
         The NDC-R, led by Guidon Shimiray Mwissa, uses child soldiers and deployed them in armed conflict. The NDC-R is also accused of human rights abuses in the eastern provinces, and of imposing illegal taxes in gold mining areas and using the proceeds to purchase weapons in violation of the arms embargo against the DRC.

                     34.

                     Lucien Nzambamwita (alias: André Kalume)

               Date of birth: 1966
         Place of birth: Cellule Nyagitabire, Sector Ruvune, Commune Kinyami, Prefecture Byumba, Rwanda
         Nationality: Rwanda
         Date of UN designation: 1 February 2018
         Other information: He is a threat to the peace, stability and security of the DRC under UNSCR 2293 paragraph 7(j).
         Additional information from the narrative summary of reasons for listing provided by the Sanctions Committee:
         Reason for listing:
         Lucien Nzambamwita was listed on 1 February 2018 pursuant to criteria set out in resolution paragraph 7(j) of resolution 2293 (2016) as reaffirmed in resolution 2360 (2017).
         Additional Information:
         Lucien Nzambamwita (aka André Kalume) is a military leader of the Force Democratique de Liberation du Rwanda (FDLR) operating in the DRC, which undermines the peace, security and stability of the DRC and is responsible for human rights abuses including targeting and killing civilians. The FDLR was sanctioned by the 1533 Committee on 31 December 2012.

                     35.

                     Gédéon Kyungu Mutanga Wa Bafunkwa Kanonga

               Designation: Katangan rebel leader
         Date of birth: 1974
         Place of birth: Manono Territory, Katanga Province (now Tanganyika Province)
         Date of UN designation: 1 February 2018
         Other information: Gédéon Kyungu belongs to the Balubakat ethnic group. After completing primary education in Likasi and secondary school in Manono, he obtained a degree in pedagogy. In 1999 he joined the Maï Maï movement, commanding from 2003 one of the most active groups in the province of Katanga. In 2006, he visited UN peacekeeping forces to integrate through the disarmament, demobilisation and reintegration (DDR) process. He escaped from prison in 2011 and surrendered in October 2016. He is a threat to the peace, stability and security of the DRC under UNSCR 2293 paragraph 7(e).
         Additional information from the narrative summary of reasons for listing provided by the Sanctions Committee:
         Reason for listing:
         Gédéon Kyungu Mutanga Wa Bafunkwa Kanonga was listed on 1 February 2018 pursuant to criteria set out in resolution paragraph 7(e) of resolution 2293 (2016) as reaffirmed in resolution 2360 (2017).
         Additional Information:
         As he was the leader of the Bakata Katanga militia (a.k.a. Kata Katanga) between 2011-2014, Gédéon Kyungu Mutanga was involved in serious human rights abuses such as killings and attacks against civilians, notably in rural zones of the Katanga province. As Commander of the armed group Bakata Katanga, which is guilty of serious human rights violations and war crimes, including attacks against civilians, in south-east DRC, Gédéon Kyungu Mutanga is therefore a threat to the peace, stability and security of DRC.’

      ANNEX II
      The entries for the persons mentioned below are deleted in Part (A) of Annex Ia to Regulation (EC) No 1183/2005:

                     ‘9.

                     Gédéon Kyungu Mutanga;

                     13.

                     Muhindo Akili Mundos.’


title: Commission Implementing Regulation (EU) 2018/198 of 7 February 2018 repealing Implementing Regulation (EU) No 716/2012 concerning the classification of certain goods in the Combined Nomenclature

text:
               10.2.2018

               EN

               Official Journal of the European Union

               L 38/7

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/198
   of 7 February 2018
   repealing Implementing Regulation (EU) No 716/2012 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 certain goods.

               (2)

               By Implementing Regulation (EU) No 716/2012 (3), the Commission classified two kinds of encapsulated colostrum powders under heading 1901 of the Combined Nomenclature as ‘food preparations of goods of headings 0401 to 0404, not containing cocoa or containing less than 5 % by weight of cocoa calculated on a totally defatted basis, not elsewhere specified or included’. Classification of the products under heading 2106 of the Combined Nomenclature was excluded as the Commission took the view that the wording of heading 1901 described the products at issue more specifically than the wording of heading 2106.

               (3)

               By Implementing Regulation (EU) 2017/1343 (4), the Commission introduced a new additional note 4 to Chapter 19 of the Combined Nomenclature to ensure that the classification of certain edible food preparations complies with the case law of the Court of Justice of the European Union. In accordance with the new additional note 4 to Chapter 19 of the Combined Nomenclature, the encapsulated colostrum powders concerned by Implementing Regulation (EC) No 716/2012 are to be classified under heading 2106.

               (4)

               As a consequence, Implementing Regulation (EU) No 716/2012 should be repealed in order to avoid potential divergences in tariff classification of encapsulated colostrum powders and to ensure the uniform application of the Combined Nomenclature within the Union.

               (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
   Implementing Regulation (EU) No 716/2012 is repealed.
   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, 7 February 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).

      (3)  Commission Implementing Regulation (EU) No 716/2012 of 30 July 2012 concerning the classification of certain goods in the Combined Nomenclature (OJ L 210, 7.8.2012, p. 6).

      (4)  Commission Implementing Regulation (EU) 2017/1343 of 18 July 2017 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 186, 19.7.2017, p. 1).


title: Commission Implementing Regulation (EU) 2018/507 of 26 March 2018 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff

text:
               27.3.2018

               EN

               Official Journal of the European Union

               L 83/11

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/507
   of 26 March 2018
   amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (1), and in particular Article 9(1)(e) thereof,
   Whereas:

               (1)

               Regulation (EEC) No 2658/87 established a nomenclature of goods (hereinafter referred to as the ‘Combined Nomenclature’), which is set out in Annex I to that Regulation.

               (2)

               In the interest of legal certainty, it is necessary to clarify the classification of capsules, tablets, pastilles and pills made from products of Chapter 15.

               (3)

               In accordance with the judgment of the Court of Justice of the European Union in Joined Cases C-410/08 to C-412/08 (2), edible food preparations intended for use as food supplements, composed principally of vegetable or animal oil with an addition of vitamins and presented in measured dosages (capsules) are to be classified under heading 2106 (‘Food preparations not elsewhere specified or included’).

               (4)

               In that judgment, the Court of Justice explained that, in the case of the goods concerned, the form of presentation is a decisive factor which reveals their function as a food supplement, since it determines the dosage of the edible preparations, the way in which they are absorbed and the place where they are supposed to become active. Consequently, the casing is a factor which, together with their content, determines the use and character of the respective goods. The fact that the raw materials of which the edible preparations are composed are partly covered by headings 1515 and 1517 of the CN does not preclude their classification under heading 2106. Headings 1515 and 1517 of the CN do not allow account to be taken of that characteristic of the goods.

               (5)

               Tariff classification problems could occur when classifying other edible preparations made from products of Chapter 15, similar in composition and purpose to the products at issue in the mentioned judgment of the Court of Justice, containing a measured dose and presented in capsules, tablets, pastilles or pills.

               (6)

               The Explanatory Notes to the Harmonized System concerning heading 2106 state that that heading includes preparations, often referred to as ‘food supplements’, and containing added vitamins and sometimes minute quantities of iron compounds which are put up in packagings with indications that they maintain general health or well-being.

               (7)

               Food supplements made of products of Chapter 15 which are presented in measured doses, such as capsules, tablets, pastilles and pills, are not covered by that Chapter, because the specific form of presentation is indicative of their function as a food supplement. Food supplements are a very specific kind of food preparations only mentioned in the Explanatory Notes of the Harmonized System to heading 2106 and in general presented in measured doses. Consequently, food preparations intended for use as food supplements, presented in measured doses and made from products of Chapter 15 cannot fulfil the requirements of any heading of that Chapter and should be classified under heading 2106.

               (8)

               For reasons of legal certainty, the provisions of the Combined Nomenclature should reflect the jurisprudence mentioned above. This has been partially achieved with the introduction of Additional note 5 to Chapter 21 by Commission Implementing Regulation (EU) No 698/2013 (3) and of Additional note 4 to Chapter 19 by Commission Implementing Regulation (EU) 2017/1343 (4). For the sake of consistency and uniformity with those previous measures, a corresponding Additional note should also be introduced to Chapter 15.

               (9)

               A new Additional note should therefore be added to Chapter 15 of Part Two of the Combined Nomenclature to ensure its uniform interpretation throughout the Union.

               (10)

               Regulation (EEC) No 2658/87 should therefore be amended accordingly.

               (11)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   In Chapter 15 of Part Two of the Combined Nomenclature set out in Annex I to Regulation (EEC) No 2658/87, the following Additional note 5 is added:

                  ‘5.

                     Food preparations made from products of Chapter 15 presented in measured doses, such as capsules, tablets, pastilles and pills, intended for use as food supplements, are excluded from this Chapter. The essential character of a food supplement is not only given by its ingredients, but also by its specific form of presentation revealing its function as a food supplement, since it determines the dosage, the way in which it is absorbed and the place where it is supposed to become active. Such food preparations are to be classified under heading 2106 insofar as they are not specified or included elsewhere.’.

   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, 26 March 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 256, 7.9.1987, p. 1.

      (2)  Judgment of 17 December 2009, Swiss Caps AG, C-410/08 to C-412/08, ECLI:EU:C:2009:794.

      (3)  Commission Implementing Regulation (EU) No 698/2013 of 19 July 2013 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 198, 23.7.2013, p. 35).

      (4)  Commission Implementing Regulation (EU) 2017/1343 of 18 July 2017 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 186, 19.7.2017, p. 1).