title: Commission Implementing Regulation (EU) 2017/2091 of 14 November 2017 concerning the non-renewal of approval of the active substance iprodione, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance. )

text:
               15.11.2017

               EN

               Official Journal of the European Union

               L 297/25

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2091
   of 14 November 2017
   concerning the non-renewal of approval of the active substance iprodione, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) and Article 78(2) thereof,
   Whereas:

               (1)

               Commission Directive 2003/31/EC (2) included iprodione as an active substance in Annex I to Council Directive 91/414/EEC (3).

               (2)

               Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

               (3)

               The approval of the active substance iprodione, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 October 2018.

               (4)

               An application for the renewal of the approval of iprodione was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

               (5)

               The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

               (6)

               The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 3 November 2015.

               (7)

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

               (8)

               On 8 June 2016 the Authority communicated to the Commission its conclusion (6) on whether iprodione can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority concluded that there is a high potential for the representative uses assessed to result in groundwater exposure above the parametric drinking water limit of 0,1 μg/l by the relevant metabolites of iprodione in situations represented by all pertinent groundwater scenarios; one relevant metabolite is even predicted to exceed 0,75 μg/l in all pertinent groundwater scenarios. In addition, the Authority also concluded that there is a high long-term risk to aquatic organisms.

               (9)

               Furthermore, in respect of one metabolite, found as a residue in plants and as an impurity in the technical material, the Authority concluded that the genotoxic potential cannot be excluded and therefore the setting of reference values for that metabolite cannot be confirmed based on the information available. Moreover, based on the available information, the dietary risk assessment could not be ﬁnalised as it is not possible to establish residue definitions for risk assessment; nevertheless, an acute consumer risk could not be excluded. Finally, the long-term risk assessment for wild mammals for all the relevant routes of exposure could not be ﬁnalised, based on the information submitted in the dossier.

               (10)

               Additionally, iprodione is classified as carcinogen category 2 in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (7) while in the conclusion of the Authority it is indicated that iprodione should be classified as carcinogen category 1B and as toxic for reproduction category 2. For the representative uses considered, residue levels exceed the default value as referred to in point (b) of Article 18(1) of Regulation (EC) No 396/2005 of the European Parliament and of the Council (8). Consequently, the requirement set out in Points 3.6.3 and 3.6.5 of Annex II to Regulation (EC) No 1107/2009 is not fulfilled.

               (11)

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

               (12)

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

               (13)

               Based on the concerns identified, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of iprodione in accordance with Article 20(1)(b) of that Regulation.

               (14)

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

               (15)

               For plant protection products containing iprodione, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 5 June 2018.

               (16)

               Commission Implementing Regulation (EU) 2017/1511 (9) extended the expiry date of iprodione to 31 October 2018 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision has been taken ahead of that extended expiry date, this Regulation should apply as soon as possible.

               (17)

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

               (18)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Non-renewal of approval of active substance
   The approval of the active substance iprodione is not renewed.
   Article 2
   Amendments to Implementing Regulation (EU) No 540/2011
   In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 50, on iprodione, is deleted.
   Article 3
   Transitional measures
   Member States shall withdraw authorisations for plant protection products containing iprodione as active substance by 5 March 2018 at the latest.
   Article 4
   Grace Period
   Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire by 5 June 2018 at the latest.
   Article 5
   Entry into force
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 14 November 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  Commission Directive 2003/31/EC of 11 April 2003 amending Council Directive 91/414/EEC to include 2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide and pendimethalin as active substances (OJ L 101, 23.4.2003, p. 3).

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

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

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

      (6)  EFSA (European Food Safety Authority), 2016. Conclusion on the peer review of the pesticide risk assessment of the active substance iprodione. EFSA Journal 2016;14(11):4609, 31 pp. doi:10.2903/j.efsa.2016.4609.

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

      (8)  Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).

      (9)  Commission Implementing Regulation (EU) 2017/1511 of 30 August 2017 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-methylcyclopropene, beta-cyfluthrin, chlorothalonil, chlorotoluron, cypermethrin, daminozide, deltamethrin, dimethenamid-p, flufenacet, flurtamone, forchlorfenuron, fosthiazate, indoxacarb, iprodione, MCPA, MCPB, silthiofam, thiophanate-methyl and tribenuron (OJ L 224, 31.8.2017, p. 115).


title: Commission Implementing Regulation (EU) 2018/256 of 20 February 2018 amending for the 281st 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:
               21.2.2018

               EN

               Official Journal of the European Union

               L 48/39

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/256
   of 20 February 2018
   amending for the 281st 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(5) 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 14 February 2018, the Sanctions Committee of the United Nations Security Council decided to amend one entry in 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,

         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 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, 20 February 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 entry ‘Djamel Lounici (alias Jamal Lounici). Address: Algeria. Date of birth: 1.2.1962. Place of birth: Algiers, Algeria. Nationality: Algerian. Other information: (a) Father's name is Abdelkader and mother's name is Johra Birouh; (b) Returned from Italy to Algeria where he resides since November 2008; (c) Son in law of Othman Deramchi. Date of designation referred to in Article 2a (4) (b): 16.1.2004’, under the heading ‘Natural persons’, is replaced by the following:

         ‘Djamel Lounici (alias Jamal Lounici). Address: Algeria. Date of birth: 1.2.1962. Place of birth: Algiers, Algeria. Nationality: Algerian. Other information: (a) Father's name is Abdelkader and mother's name is Johra Birouh; (b) Returned from France to Algeria where he resides since September 2008. Date of designation referred to in Article 7d(2)(i): 16.1.2004.’


title: Commission Implementing Regulation (EU) 2018/260 of 21 February 2018 terminating the investigation concerning the possible circumvention of anti-dumping measures imposed by Council Implementing Regulation (EU) No 1008/2011, as amended by Implementing Regulation (EU) No 372/2013, on imports of hand pallet trucks and their essential parts originating in the People's Republic of China by imports consigned from Vietnam, whether declared as originating in Vietnam or not

text:
               22.2.2018

               EN

               Official Journal of the European Union

               L 49/16

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/260
   of 21 February 2018
   terminating the investigation concerning the possible circumvention of anti-dumping measures imposed by Council Implementing Regulation (EU) No 1008/2011, as amended by Implementing Regulation (EU) No 372/2013, on imports of hand pallet trucks and their essential parts originating in the People's Republic of China by imports consigned from Vietnam, whether declared as originating in Vietnam or not
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (1) (‘the basic Regulation’), and in particular Articles 13(3) and 14(5) thereof,
   Whereas:
   1.   PROCEDURE

   1.1.   Previous investigations and existing measures

               (1)

               In July 2005, by Regulation (EC) No 1174/2005 (2) the Council imposed a definitive anti-dumping duty on imports of hand pallet trucks and their essential parts (‘hand pallet trucks’) originating in the People's Republic of China (‘the PRC’ or ‘China’). The measures consisted of an ad valorem anti-dumping duty ranging between 7,6 % and 46,7 % (‘the original measures’).

               (2)

               In July 2008, by Regulation (EC) No 684/2008 (3) the Council, following an ex officio partial interim review under Article 11(3) of the basic Regulation, clarified the scope of the measures and excluded certain products, high lifters, stackers, scissor lifts and weighing trucks, that were found to be distinct from hand pallet trucks due to their characteristics and specific functions and end-uses, from the original anti-dumping measures.

               (3)

               In June 2009, by Regulation (EC) No 499/2009 (4) the Council, following an anti-circumvention investigation under Article 13 of the basic Regulation, extended the definitive anti-dumping duty applicable to ‘all other companies’ imposed by Regulation (EC) No 1174/2005 to hand pallet trucks consigned from Thailand whether declared as originating in Thailand or not.

               (4)

               In October 2011, by Implementing Regulation (EU) No 1008/2011 (5), the Council, following an expiry review pursuant to Article 11(2) of the basic Regulation, imposed a definitive anti-dumping duty on imports of hand pallet trucks originating in the PRC.

               (5)

               In April 2013, by Implementing Regulation (EU) No 372/2013 (6), the Council, following an interim review pursuant to Article 11(3) of the basic Regulation, amended Regulation (EU) No 1008/2011, and imposed a duty rate of 70,8 % applicable to all imports into the Union of hand pallet trucks originating in the PRC.

               (6)

               In September 2014, by Implementing Regulation (EU) No 946/2014 (7), the European Commission (‘the Commission’), following a new exporter review pursuant to Article 11(4) of the basic Regulation, amended Regulation (EU) No 1008/2011, imposing an individual duty rate of 54,1 % on imports of hand pallet trucks from Ningbo Logitrans Handling Equipment Co.

               (7)

               In August 2016, by Implementing Regulation (EU) 2016/1346 (8) the Commission, following an anti-circumvention investigation under Article 13 of the basic Regulation, extended the definitive anti-dumping duties in force to imports of slightly modified hand pallet trucks incorporating a weight indication system not integrated in the chassis (the forks) originating in the PRC.

               (8)

               In November 2017, by Implementing Regulation (EU) 2017/2206 (9), the Commission, following a second expiry review pursuant to Article 11(2) of the basic Regulation, imposed a definitive anti-dumping duty on imports of hand pallet trucks originating in the PRC.

               (9)

               The measures currently in force are a definitive anti-dumping duty on imports of hand pallet trucks and their essential parts originating in the PRC consisting of an ad valorem duty established at 70,8 %.

         1.2.   Request

               (10)

               The Commission received a request pursuant to Articles 13(3) and 14(5) of the basic Regulation to investigate the possible circumvention of the anti-dumping measures imposed on hand pallet trucks and their essential parts originating in the PRC by imports consigned from Vietnam, whether declared as originating in Vietnam or not, and to make such imports subject to registration.

               (11)

               The request was lodged on 6 June 2017 by two Union producers of hand pallet trucks and their essential parts, Toyota Material Handling Manufacturing Sweden AB and PR Industrial S.r.l. (‘the applicants’).

               (12)

               The request contained sufficient prima facie evidence on a change in the pattern of trade between the Union, the PRC and Vietnam which appeared to stem from a practice, process or work for which there was insufficient due cause or economic justification other than the imposition of the duty, namely the consignment of the product concerned via Vietnam to the Union after having undergone assembly operations in Vietnam. The request contained sufficient prima facie evidence showing that such assembly operations constituted circumvention as Chinese parts constituted above 60 % of the total value of the assembled product and the value added during the assembly operation was lower than 25 % of the manufacturing cost.

               (13)

               Furthermore, the request contained sufficient prima facie evidence that the practice described above was undermining the remedial effects of the existing anti- dumping measures both in terms of quantities and prices and that the prices of the product under investigation were dumped in relation to the normal value previously established for the product concerned.

         1.3.   Product concerned and product under investigation

               (14)

               The product subject to this investigation is hand pallet trucks and their essential parts, i.e. chassis and hydraulics, currently falling within CN codes ex 8427 90 00 and ex 8431 20 00, originating in the People's Republic of China. For the purpose of this Regulation, hand pallet trucks shall be trucks with wheels supporting lifting fork arms for handling pallets, designed to be manually pushed, pulled and steered, on smooth, level, hard surfaces, by a pedestrian operator using an articulated tiller. The hand pallet trucks are only designed to raise a load, by pumping the tiller, to a height sufficient for transporting and do not have any other additional functions or uses such as for example (i) to move and to lift the loads in order to place them higher or assist in storage of loads (highlifters); (ii) to stack one pallet above the other (stackers); (iii) to lift the load to a working level (scissorlifts); or (iv) to lift and to weigh the loads (weighing trucks) (‘the product concerned’).

               (15)

               The product under investigation is the same product as that defined above but consigned from Vietnam, whether declared as originating in Vietnam or not, currently falling within the same CN codes as the product concerned (‘the product under investigation’).

               (16)

               The investigation showed that the hand pallet trucks and their essential parts, as defined above, exported from the PRC to the Union and those consigned from Vietnam have the same basic physical and technical characteristics and have the same uses, and are therefore to be considered as like products within the meaning of Article 1(4) of the basic Regulation.

         1.4.   Initiation

               (17)

               Having determined, after having informed the Member States, that sufficient prima facie evidence existed for the initiation of an investigation pursuant to Articles 13(3) and 14(5) of the basic Regulation, the Commission decided to investigate the possible circumvention of the anti-dumping measures imposed on imports of hand pallet trucks and their essential parts originating in China and to make imports of hand pallet trucks and their essential parts consigned from Vietnam, whether declared as originating in Vietnam or not, subject to registration.

               (18)

               The investigation was initiated by Commission Implementing Regulation (EU) 2017/1348 (10) (‘the initiating Regulation’).

         1.5.   Investigation period and reporting period

               (19)

               The investigation period covered the period from 1 January 2011 to 30 June 2017 (‘the investigation period’). Data were collected for the investigation period to investigate, inter alia, the alleged change in the pattern of trade following the imposition of the measures as well as following the increase of the definitive anti-dumping duty by Implementing Regulation (EU) No 372/2013 and the existence of a practice, process or work for which there was insufficient due cause or economic justification other than the imposition of the duty. More detailed data were collected for the reporting period from 1 July 2016 to 30 June 2017 (‘the reporting period’) in order to examine if imports were undermining the remedial effect of the measures in force in terms of prices and/or quantities and the existence of dumping.

         1.6.   Investigation

               (20)

               The Commission officially informed the authorities of the PRC and Vietnam, the exporting producers and traders in those countries, the importers in the Union known to be concerned and the Union industry of the initiation of the investigation. Questionnaires were sent to the producers/exporters in the PRC and Vietnam known to the Commission or which made themselves known within the deadlines specified in recital 15 of the initiating Regulation. Questionnaires were also sent to importers in the Union.

               (21)

               Interested parties were given the opportunity to make their views known in writing and to request a hearing within the time limit set in the initiating Regulation.

               (22)

               Three companies in Vietnam, one of which had not started producing hand pallet trucks in the investigation period, and four unrelated importers made themselves known.

               (23)

               Two Vietnamese companies submitted a questionnaire reply and requested an exemption from the possible extension of the measures, in accordance with Article 13(4) of the basic Regulation.

               (24)

               Four unrelated importers in the Union provided questionnaire replies.

               (25)

               Verification visits were carried out at the premises of the following companies in Vietnam:

                           —

                           Vietmachine Producing and Trading Co., Ltd, and

                           —

                           D&D Technologies Co., Ltd.

         2.   RESULTS OF THE INVESTIGATION

   2.1.   General considerations

               (26)

               In accordance with Article 13(1) of the basic Regulation, the following elements should be analysed successively in order to assess possible circumvention:

                           —

                           whether there was a change in the pattern of trade between the PRC and the Union,

                           —

                           if this change stemmed from a practice, process or work for which there was insufficient due cause or economic justification other than the imposition of the anti-dumping measures in force,

                           —

                           if there is evidence of injury or the remedial effects of the anti-dumping measures in force were being undermined in terms of the prices and/or quantities of the product under investigation, and

                           —

                           whether there is evidence of dumping in relation to the normal values previously established for the product concerned.

               (27)

               In the present investigation, since the prima facie evidence provided by the applicants in the request pointed to assembly operations in Vietnam, the Commission more specifically analysed whether the criteria set out in Article 13(2) of the basic Regulation were met, in particular:

                           —

                           whether the assembly operation started or substantially increased since, or just prior to, the initiation of the anti-dumping investigation and the parts concerned are from the country subject to measures, and

                           —

                           whether the parts constitute 60 % or more of the total value of the parts of the assembled product and whether the added value of the parts brought in, during the assembly or completion operation, was greater than 25 % of the manufacturing costs.

               (28)

               The information on export sales submitted by the two Vietnamese companies could be reconciled to the data available in the Comext database (11) on the imports of the product under investigation from Vietnam. It was therefore considered that these companies were the sole exporters of the product under investigation from Vietnam to the Union during the reporting period.

         2.2.   Condition of Article 13(2)(a): Start or substantial increase of operations

               (29)

               For both companies, the sales volume to the Union market has constantly increased between 2013, when the definitive anti-dumping duty was increased to 70,8 % by Implementing Regulation (EU) No 372/2013, and the reporting period. Both companies more than tripled their sales volume to the Union market during this period. Before 2013, the volume exported by these companies to the Union market was negligible or absent. In parallel, the Chinese exports to the Union market of the product under investigation significantly fell by 65 %. It was therefore concluded that there was a change in the pattern of trade between the Union and the PRC on the one hand and the Union and Vietnam on the other hand and that therefore the condition set out in Article 13(2)(a) of the basic Regulation was met.

         2.3.   Conditions of Article 13(2)(b): criteria of 60 % and 25 %

               (30)

               In accordance with Article 13(2)(b) of the basic Regulation, in order to establish circumvention, the Commission had to verify that the parts used in the assembly operation from the countries subject to the measures constituted 60 % or more of the total value of the parts of the assembled product and that the value added to the parts brought in was not greater than 25 % of the manufacturing cost.

         (i)   First criterion: 60 % of the total value of the parts constituting the assembled product

               (31)

               For both cooperating companies it was found that the parts from the country subject to measures did not constitute 60 % or more of the total value of the parts of the assembled products.

               (32)

               Consequently, the assembly operations carried out by the cooperating Vietnamese companies cannot be considered as circumvention within the meaning of Article 13(2) of the basic Regulation.

         (ii)   Second criterion: 25 % of the value added to the parts brought in

               (33)

               As the investigation showed that the 60 % criterion was not met and the assembly operation cannot be considered as circumvention within the meaning of Article 13(2) of the basic Regulation, it was not considered necessary to examine this criterion.

         2.4.   Conditions of Article 13(2)(c): undermining of the remedial effects of the duty and evidence of dumping

               (34)

               As the investigation showed that the 60 % criterion was not met and the assembly operation cannot be considered as circumvention within the meaning of Article 13(2) of the basic Regulation, it was not considered necessary to examine these aspects.

               (35)

               Since the two investigated companies represent 100 % of the Vietnamese imports during the reporting period it could not be established that measures in force with regard to China are being circumvented by imports consigned from Vietnam.

         3.   TERMINATION OF THE INVESTIGATION

               (36)

               In view of the findings mentioned in recitals 30 to 32, the current anti-circumvention investigation should be terminated. The registration of imports of hand pallet trucks and their essential parts consigned from Vietnam, whether declared as originating in Vietnam or not, introduced by the Initiating Regulation should therefore be discontinued, and that Regulation should be repealed.

               (37)

               Interested parties were informed of the essential facts and considerations on the basis of which the Commission intended to terminate the investigation and were given the opportunity to comment. The comments received were not of a nature to change the above conclusions.

               (38)

               The measures provided for in this regulation are in accordance with the opinion of the Committee established by Article 15(1) of Regulation (EU) 2016/1036,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The investigation initiated by Implementing Regulation (EU) 2017/1348 in order to determine if imports into the Union of hand pallet trucks and their essential parts, i.e. chassis and hydraulics, originating in the People's Republic of China, currently falling within CN codes ex 8427 90 00 and ex 8431 20 00 and consigned from Vietnam, whether declared as originating in Vietnam or not (TARIC codes 8427900013 and 8431200013) are circumventing the measures imposed by Implementing Regulation (EU) No 1008/2011, as amended by Implementing Regulation (EU) No 372/2013, is hereby terminated.
   Article 2
   Customs authorities shall discontinue the registration of imports established in accordance with Article 2 of Implementing Regulation (EU) 2017/1348.
   Article 3
   Implementing Regulation (EU) 2017/1348 is hereby repealed.
   Article 4
   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, 21 February 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  Council Regulation (EC) No 1174/2005 of 18 July 2005 imposing a definitive anti-dumping duty and collecting definitely the provisional duty imposed on imports of hand pallet trucks and their essential parts originating in the People's Republic of China (OJ L 189, 21.7.2005, p. 1).

      (3)  Council Regulation (EC) No 684/2008 of 17 July 2008 clarifying the scope of the anti-dumping measures imposed by Regulation (EC) No 1174/2005 on imports of hand pallet trucks and their essential parts originating in the People's Republic of China (OJ L 192, 19.7.2008, p. 1).

      (4)  Council Regulation (EC) No 499/2009 of 11 June 2009 extending the definitive anti-dumping duty imposed by Regulation (EC) No 1174/2005 on imports of hand pallet trucks and their essential parts originating in the People's Republic of China to imports of the same product consigned from Thailand, whether declared as originating in Thailand or not (OJ L 151, 16.6.2009, p. 1).

      (5)  Council Implementing Regulation (EU) No 1008/2011 of 10 October 2011 imposing a definitive anti-dumping duty on imports of hand pallet trucks and their essential parts originating in the People's Republic of China as extended to imports of hand pallet trucks and their essential parts consigned from Thailand, whether declared as originating in Thailand or not, following an expiry review pursuant to Article 11(2) of Regulation (EC) No 1225/2009 (OJ L 268, 13.10.2011, p. 1).

      (6)  Council Implementing Regulation (EU) No 372/2013 of 22 April 2013 amending Implementing Regulation (EU) No 1008/2011 imposing a definitive anti-dumping duty on imports of hand pallet trucks and their essential parts originating in the People's Republic of China following a partial interim review pursuant to Article 11(3) of Regulation (EC) No 1225/2009 (OJ L 112, 24.4.2013, p. 1).

      (7)  Commission Implementing Regulation (EU) No 946/2014 of 4 September 2014 amending Council Implementing Regulation (EU) No 1008/2011 imposing a definitive anti- dumping duty on imports of hand pallet trucks and their essential parts originating in the People's Republic of China following a ‘new exporter’ review pursuant to Article 11(4) of Council Regulation (EC) No 1225/2009 (OJ L 265, 5.9.2014, p. 7).

      (8)  Commission Implementing Regulation (EU) 2016/1346 of 8 August 2016 extending the definitive anti-dumping duty imposed by Council Implementing Regulation (EU) No 1008/2011, as amended by Council Implementing Regulation (EU) No 372/2013, on imports of hand pallet trucks and their essential parts originating in the People's Republic of China to imports of slightly modified hand pallet trucks originating in the People's Republic of China (OJ L 214, 9.8.2016, p. 1).

      (9)  Commission Implementing Regulation (EU) 2017/2206 of 29 November 2017 imposing a definitive anti-dumping duty on hand pallet trucks and their essential parts originating in the People's Republic of China following an expiry review pursuant to Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the Council (OJ L 314, 30.11.2017, p. 12).

      (10)  Commission Implementing Regulation (EU) 2017/1348 of 19 July 2017 initiating an investigation concerning the possible circumvention of anti-dumping measures imposed by Council Implementing Regulation (EU) No 1008/2011, as amended by Implementing Regulation (EU) No 372/2013, on imports of hand pallet trucks and their essential parts originating in the People's Republic of China by imports consigned from Vietnam, whether declared as originating in Vietnam or not, and making such imports subject to registration (OJ L 188, 20.7.2017, p. 1).

      (11)  Comext is a database on foreign trade statistics managed by Eurostat.


title: Council Implementing Regulation (EU) 2018/565 of 12 April 2018 implementing Regulation (EU) No 359/2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Iran

text:
               13.4.2018

               EN

               Official Journal of the European Union

               L 95/1

         COUNCIL IMPLEMENTING REGULATION (EU) 2018/565
   of 12 April 2018
   implementing Regulation (EU) No 359/2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Iran
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EU) No 359/2011 of 12 April 2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Iran (1), and in particular Article 12(1) thereof,
   Having regard to the proposal of the High Representative of the Union for Foreign Affairs and Security Policy,
   Whereas:

               (1)

               On 12 April 2011 the Council adopted Regulation (EU) No 359/2011.

               (2)

               On the basis of a review of Council Decision 2011/235/CFSP (2), the Council has decided that the restrictive measures set out therein should be renewed until 13 April 2019.

               (3)

               The Council has also concluded that the entries concerning 29 persons and one entity included in Annex I to Regulation (EU) No 359/2011 should be updated.

               (4)

               Annex I to Regulation (EU) No 359/2011 should be amended accordingly,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex I to Regulation (EU) No 359/2011 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 Luxembourg, 12 April 2018.

            For the Council

            The President

         T. DONCHEV

      (1)  OJ L 100, 14.4.2011, p. 1.

      (2)  Council Decision 2011/235/CFSP of 12 April 2011 concerning restrictive measures directed against certain persons and entities in view of the situation in Iran (OJ L 100, 14.4.2011, p. 51).

      ANNEX
      The following entries replace the corresponding entries in the list of natural and legal persons, entities and bodies set out in Annex I to Regulation (EU) No 359/2011:

         ‘Persons

                     Name

                     Identifying information

                     Reasons

                     Date of listing

                     1.

                     AHMADI-MOQADDAM Esmail

                     POB: Tehran (Iran)
                     DOB: 1961

                     Former Senior Advisor for Security Affairs to the Chief of the Armed Forces General Staff. Former Chief of Iran's National Police from 2005 until early 2015. Forces under his command led brutal attacks on peaceful protests, and a violent night time attack on the dormitories of Tehran University on 15 June 2009. Currently head of Iran's Headquarters in support of the Yemeni People.

                     12.4.2011

                     3.

                     ARAGHI (ERAGHI) Abdollah

                     Former Deputy Head of IRGC's Ground Forces. He had a direct and personal responsibility in the crackdown of protests all through the summer of 2009.

                     12.4.2011

                     9.

                     NAQDI Mohammad-Reza

                     POB: Najaf (Iraq)
                     DOB: Circa 1952

                     Deputy Chief of the IRGC for cultural and social affairs. Former Commander of the Basij. As commander of the IRGC's Basij Forces, Naqdi was responsible for or complicit in Basij abuses occurring in late 2009, including the violent response to the December 2009 Ashura Day protests, which resulted in up to 15 deaths and the arrests of hundreds of protesters. Prior to his appointment as commander of the Basij in October 2009, Naqdi was the head of the intelligence unit of the Basij responsible for interrogating those arrested during the post-election crackdown.

                     12.4.2011

                     10.

                     RADAN Ahmad-Reza

                     POB: Isfahan (Iran)
                     DOB:1963

                     Formerly in charge of the Centre for Strategic Studies of the Iranian Law Enforcement Force, a body linked to the National Police. Former Head of the Police Strategic Studies Centre, former Deputy Chief of Iran's National Police until June 2014. As Deputy Chief of National Police from 2008, Radan was responsible for beatings, murder, and arbitrary arrests and detentions against protestors that were committed by the police forces. Currently IRGC commander in charge of training Iraqi ‘anti-terrorist’ forces.

                     12.4.2011

                     11.

                     RAJABZADEH Azizollah

                     Former Head of Tehran Disaster Mitigation Organisation (TDMO). Former Head of Tehran Police (until January 2010).
                     As Commander of the Law Enforcement Forces in the Greater Tehran, Azizollah Rajabzadeh is the highest ranking accused in the case of abuses in Kahrizak Detention Centre.

                     12.4.2011

                     12.

                     SAJEDI-NIA Hossein

                     Police Operations Deputy Commander. Former head of Tehran Police, former Deputy Chief of Iran's National Police responsible for Police Operations. He is in charge of coordinating, for the Ministry of Interior, repression operations in the Iranian capital.

                     12.4.2011

                     13.

                     TAEB Hossein

                     POB: Tehran
                     DOB: 1963

                     Head of IRGC Intelligence. Former Deputy IRGC commander for intelligence. Former Commander of the Basij until October 2009. Forces under his command participated in mass beatings, murders, detentions and tortures of peaceful protestors.

                     12.4.2011

                     16.

                     HADDAD Hassan (alias Hassan ZAREH DEHNAVI)

                     Former Deputy Safety Officer of Teheran Revolutionary Court. Former Judge, Tehran Revolutionary Court, branch 26. He was in charge of the detainee cases related to the post-election crises and regularly threatened families of detainees in order to silence them. He has been instrumental in issuing detention orders to the Kahrizak Detention Centre. In November 2014, his role in the deaths of detainees was officially recognised by the Iranian authorities.

                     12.4.2011

                     21.

                     MOHSENI-EJEI Gholam-Hossein

                     POB: Ejiyeh
                     DOB: circa 1956

                     Member of the Expediency Council. Prosecutor General of Iran since September 2009 and Deputy Head and spokesman of the Judiciary. Former Intelligence minister during the 2009 elections. While he was Intelligence minister during the 2009 election, intelligence agents under his command were responsible for detention, torture and extraction of false confessions under pressure from hundreds of activists, journalists, dissidents, and reformist politicians. In addition, political figures were coerced into making false confessions under unbearable interrogations, which included torture, abuse, blackmail, and the threatening of family members.

                     12.4.2011

                     26.

                     SHARIFI Malek Adjar (aka: SHARIFI Malek Ajdar)

                     Judge at the Supreme Court, head of the 43rd section. Former Head of East Azerbaidjan Judiciary. He was responsible for Sakineh Mohammadi-Ashtiani's trial.

                     12.4.2011

                     28.

                     YASAGHI Ali-Akbar

                     Judge of the Supreme Court, head of the 44th section. Deputy Chief Executive Officer of Setad-e Dieh Foundation. Former Chief Judge, Mashhad Revolutionary Court. Trials under his jurisdiction have been conducted summarily and inside closed session, without adherence to basic rights of the accused. As execution rulings were issued en masse, death sentences were issued without proper observance of fair hearing procedures.

                     12.4.2011

                     32.

                     ZANJIREI Mohammad-Ali

                     Senior advisor to Head, and former Deputy Head of Iran's Prisons Organisation, responsible for abuses and deprivation of rights in detention centre. He ordered the transfer of many inmates into solitary confinement.

                     12.4.2011

                     33.

                     ABBASZADEH-MESHKINI Mahmoud

                     Advisor to the Human Right Council. Former secretary of the Human Right Council. Former governor of Ilam Province. Former Interior Ministry's political director. As Head of the Article 10 Committee of the Law on Activities of Political Parties and Groups he was in charge of authorising demonstrations and other public events and registering political parties.
                     In 2010, he suspended the activities of two reformist political parties linked to Mousavi — the Islamic Iran Participation Front and the Islamic Revolution Mujahedeen Organisation.
                     From 2009 onwards he has consistently and continuously prohibited all non-governmental gatherings, therefore denying a constitutional right to protest and leading to many arrests of peaceful demonstrators in contravention of the right to freedom of assembly.
                     He also denied in 2009 the opposition a permit for a ceremony to mourn people killed in protests over the Presidential elections.

                     10.10.2011

                     34.

                     AKBARSHAHI Ali-Reza

                     Former Director-General of Iran's Drug Control Headquarters (aka: Anti-Narcotics Headquarters). Former Commander of Tehran Police. Under his leadership, the police force was responsible for the use of extrajudicial force on suspects during arrest and pre-trial detention. The Tehran police were also implicated in raids on Tehran university dorms in June 2009, when according to an Iranian Majlis commission, more than 100 students were injured by the police and Basiji. Currently head of the railway police.

                     10.10.2011

                     36.

                     AVAEE Seyyed Ali-Reza (aka: AVAEE Seyyed Alireza)

                     Minister of Justice. Former Director of the special investigations office. Until July 2016 deputy Minister of Interior and head of the Public register. Advisor to the Disciplinary Court for Judges since April 2014. Former President of the Tehran Judiciary. As President of the Tehran Judiciary he has been responsible for human rights violations, arbitrary arrests, denials of prisoners' rights and an increase in executions.

                     10.10.2011

                     40.

                     HABIBI Mohammad Reza

                     Head of the Ministry of Justice office in Yazd. Former Deputy Prosecutor of Isfahan. Complicit in proceedings denying defendants a fair trial — such as Abdollah Fathi, executed in May 2011 after his right to be heard and mental health issues were ignored by Habibi during his trial in March 2010. He is, therefore, complicit in a grave violation of the right to due process, contributing to the excessive and increasing use of the death penalty and a sharp increase in executions since the beginning of 2011.

                     10.10.2011

                     45.

                     JOKAR Mohammad Saleh

                     Deputy for Parliamentary Affairs of the Revolutionary Guards. From 2011 until 2016 parliamentary deputy for Yazd Province and Member of the parliamentary Committee for National Security and Foreign Policy. Former Commander of Student Basij Forces.
                     In the capacity of Commander of Student Basij Forces he was actively involved in suppressing protests in schools and universities and extra-judicial detention of activists and journalists.

                     10.10.2011

                     48.

                     MAHSOULI Sadeq (aka: MAHSULI Sadeq)

                     POB: Oroumieh (Iran)
                     DOB: 1959/60

                     Advisor to Former President Mahmoud Ahmadinejad and current member of the Expediency Council and Deputy Chief of the Perseverance Front. Minister of Welfare and Social Security between 2009 and 2011. Minister of the Interior until August 2009. As Interior Minister, Mahsouli had authority over all police forces, interior ministry security agents, and plainclothes agents. The forces under his direction were responsible for attacks on the dormitories of Tehran University on 14 June 2009 and the torture of students in the basement of the Ministry (the notorious basement level 4). Other protestors were severely abused at the Kahrizak Detention Centre, which was operated by police under Mahsouli's control.

                     10.10.2011

                     50.

                     OMIDI Mehrdad (aka: Reza; OMIDI Reza)

                     Head of section VI of the police, investigation department. Former Head of the Intelligence Services within the Iranian Police. Former Head of the Computer Crimes Unit of the Iranian Police. He is responsible for thousands of investigations and indictments of reformists and political opponents using the Internet. He is thus responsible for grave human rights violations in the repression of persons who speak out in defence of their legitimate rights, including freedom of expression.

                     10.10.2011

                     51.

                     SALARKIA Mahmoud

                     Former director of Tehran Football Club ‘Persepolis’

                     Former Head of the Petrol and Transport commission of the City of Tehran. Deputy to the Prosecutor-General of Tehran for Prison Affairs during the crackdown of 2009.
                     As Deputy to the Prosecutor-General of Tehran for Prison Affairs he was directly responsible for many of the arrest warrants against innocent, peaceful protesters and activists. Many reports from human rights defenders show that virtually all those arrested are, on his instruction, held incommunicado without access to their lawyer or families, and without charge, for varying lengths of time, often in conditions amounting to enforced disappearance. Their families are often not notified of the arrest.

                     10.10.2011

                     53.

                     TALA Hossein (aka: TALA Hosseyn)

                     Mayor of Eslamshahr. Former Iranian MP. Former Governor-General (‘Farmandar’) of Tehran Province until September 2010, he was responsible for the intervention of police forces and therefore for the repression of demonstrations. He received a prize in December 2010 for his role in the post-election repression.

                     10.10.2011

                     54.

                     TAMADDON Morteza (aka: TAMADON Morteza)

                     POB: Shahr Kord-Isfahan
                     DOB: 1959

                     Former Head of Tehran provincial Public Security Council. Former IRGC Governor-General of Tehran Province. In his capacity as governor and head of Tehran provincial Public Security Council, he bears overall responsibility for all repressive activities undertaken by the IRGC in Tehran province, including cracking down on political protests since June 2009. Currently board member at Khajeh Nasireddin Tusi University of Technology.

                     10.10.2011

                     55.

                     ZEBHI Hossein

                     Judge of the Supreme Court. Former Deputy to the Prosecutor-General of Iran. He is in charge of several judicial cases linked to the post-election protests.

                     10.10.2011

                     59.

                     BAKHTIARI Seyyed Morteza

                     POB: Mashad (Iran)
                     DOB: 1952

                     Deputy custodian of Imam Reza shrine. Former Official of the Special Clerical Tribunal. Former Minister of Justice from 2009 to 2013. During his time as Minister of Justice, prison conditions within Iran fell well below accepted international standards, and there was widespread mistreatment of prisoners. In addition, he played a key role in threatening and harassing the Iranian diaspora by announcing the establishment of a special court to deal specifically with Iranians who live outside the country. He also oversaw a sharp increase in the number of executions in Iran, including secret executions not announced by the government, and executions for drug-related offences.

                     10.10.2011

                     60.

                     HOSSEINI Dr Mohammad (aka: HOSSEYNI Dr Seyyed Mohammad; Seyed, Sayyed and Sayyid)

                     POB: Rafsanjan, Kerman
                     DOB: 1961

                     Advisor to Former President Mahmoud Ahmadinejad and spokesperson for YEKTA hardline political faction. Former Minister of Culture and Islamic Guidance (2009-2013). Ex-IRGC, he was complicit in the repression of journalists.

                     10.10.2011

                     69.

                     MORTAZAVI Seyyed Solat

                     POB: Farsan, Tchar Mahal-o-Bakhtiari (South) - (Iran)
                     DOB: 1967

                     Former mayor of the second largest city of Iran, Mashad, where public executions regularly happen. Former Deputy Interior Minister for Political Affairs. He was responsible for directing repression of persons who spoke up in defence of their legitimate rights, including freedom of expression. Later appointed as Head of the Iranian Election Committee for the parliamentarian elections in 2012 and for the presidential elections in 2013.

                     23.3.2012

                     73.

                     FAHRADI Ali

                     Deputy head of Inspectorate of Legal Affairs and Public Inspection of the Ministry of Justice of Tehran. Former prosecutor of Karaj. Responsible for grave violations of human rights, including prosecuting trials in which the death penalty is passed. There have been a high number of executions in Karaj region during his time as prosecutor.

                     23.3.2012

                     75.

                     RAMEZANI Gholamhossein

                     Since 2011 Chief of the Intelligence of the Ministry of Defence; from November 2009 to March 2011: Commander of Intelligence of the Pasdaran; from March 2008 to November 2009: Deputy Commander of Intelligence of the Pasdaran; from April 2006 to March 2008: Head of Protection and Intelligence of the Pasdaran. Involved in the suppression of freedom of expression, including by being associated with those responsible for the arrests of bloggers/journalists in 2004, and reported to have had a role in the suppression of the post-election protests in 2009.

                     23.3.2012

                     82.

                     SARAFRAZ Mohammad (Dr) (aka: Haj-agha Sarafraz)

                     POB: Tehran
                     DOB: appr. 1963
                     Place of Residence: Tehran Place of Work: IRIB and PressTV HQ, Tehran

                     Former member of the Supreme Council of Cyber Space. Former President of the Islamic Republic of Iran Broadcasting (IRIB). Former Head of IRIB World Service and Press TV, responsible for all programming decisions. Closely associated with the state security apparatus. Under his direction Press TV, along with IRIB, has worked with the Iranian security services and prosecutors to broadcast forced confessions of detainees, including that of Iranian-Canadian journalist and film-maker Maziar Bahari, in the weekly programme ‘Iran Today’. Independent broadcast regulator OFCOM fined Press TV in the UK GBP 100 000  for broadcasting Bahari's confession in 2011, which was filmed in prison whilst Bahari was under duress. Sarafraz therefore is associated with violating the right to due process and fair trial.

                     12.3.2013

               Entities

                     Name

                     Identifying information

                     Reasons

                     Date of listing

                     1.

                     Cyber Police

                     Location: Tehran, Iran
                     Website: http://www.cyberpolice.ir

                     The Iranian Cyber Police, founded in January 2011, is a unit of the Islamic Republic of Iran Police, which at that time until early 2015 was headed by Esmail Ahmadi-Moqaddam (listed). Ahmadi-Moqaddam underlined that the Cyber Police would take on anti-revolutionary and dissident groups who used internet-based social networks in 2009 to trigger protests against the re-election of President Mahmoud Ahmadinejad. In January 2012, the Cyber Police issued new guidelines for internet cafés, requiring users to provide personal information that would be kept by café owners for six months, as well as a record of the websites they visited. The rules also require café owners to install closed-circuit television cameras and maintain the recordings for six months. These new rules may create a logbook that authorities can use to track down activists or whoever is deemed a threat to national security.
                     In June 2012, Iranian media reported that the Cyber Police would be launching a crackdown on virtual private networks (VPNs). On 30 October 2012, the Cyber Police arrested the blogger Sattar Beheshti without a warrant for ‘actions against national security on social networks and Facebook’. Beheshti had criticised the Iranian government in his blog. Beheshti was found dead in his prison cell on 3 November 2012, and is believed to have been tortured to death by the Cyber Police authorities.

                     12.3.2013’


title: Commission Implementing Regulation (EU) 2018/1025 of 19 July 2018 amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq

text:
               20.7.2018

               EN

               Official Journal of the European Union

               L 184/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1025
   of 19 July 2018
   amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1210/2003 of 7 July 2003 concerning certain specific restrictions on economic and financial relations with Iraq and repealing Regulation (EC) No 2465/96 (1), and in particular Article 11(b) thereof,
   Whereas:

               (1)

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

               (2)

               On 13 July 2018, the Sanctions Committee of the United Nations Security Council decided to remove two entries from the list of persons or entities to whom the freezing of funds and economic resources should apply.

               (3)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex III to Regulation (EC) No 1210/2003 is amended as set out in the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 19 July 2018.

            For the Commission,

            On behalf of the President,

            Head of the Service for Foreign Policy Instruments

      (1)  OJ L 169, 8.7.2003, p. 6.

      ANNEX

         In Annex III, the following entries are deleted:

                                 ‘62.

                                 IRAQI LIFE INSURANCE COMPANY. Addresses: (a) Aqaba Bin Nafie Square, P.O. Box 989, Baghdad, Iraq; (b) P.O. Box 989, Karradah Al Sharkiya, Baghdad, Iraq.’

                                 ‘96.

                                 NATIONAL INSURANCE COMPANY [IRAQ]. Addresses: (a) Khullani Street, P.O. Box 248, Baghdad, Iraq; (b) Aman Building, Khullani Square, Baghdad, Iraq.’


title: Commission Implementing Regulation (EU) 2018/1026 of 19 July 2018 on the minimum selling price for skimmed milk powder for the 22nd partial invitation to tender within the tendering procedure opened by Implementing Regulation (EU) 2016/2080

text:
               20.7.2018

               EN

               Official Journal of the European Union

               L 184/3

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1026
   of 19 July 2018
   on the minimum selling price for skimmed milk powder for the 22nd 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 22nd partial invitation to tender, a minimum selling price should be fixed.

               (3)

               The Committee for the Common Organisation of the Agricultural Markets has not delivered an opinion within the time limit laid down by its Chair,

         HAS ADOPTED THIS REGULATION:
   Article 1
   For the 22nd 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 17 July 2018, the minimum selling price shall be 112,50 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, 19 July 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) 2018/1060 of 26 July 2018 renewing the approval of the active substance trifloxystrobin in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance.)

text:
                  27.7.2018

                  EN

                  Official Journal of the European Union

                  L 190/3

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1060
         of 26 July 2018
         renewing the approval of the active substance trifloxystrobin in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) thereof,
         Whereas:

                     (1)

                     Commission Directive 2003/68/EC (2) included trifloxystrobin as an active substance in Annex I to Council Directive 91/414/EEC (3).

                     (2)

                     Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

                     (3)

                     The approval of the active substance trifloxystrobin, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2018.

                     (4)

                     An application for the renewal of the approval of trifloxystrobin was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

                     (5)

                     The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

                     (6)

                     The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 29 September 2016.

                     (7)

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

                     (8)

                     On 19 September 2017 the Authority communicated to the Commission its conclusion (6) on whether trifloxystrobin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft renewal report for trifloxystrobin to the Standing Committee on Plants, Animals, Food and Feed on 23 March 2018.

                     (9)

                     The applicant was given the opportunity to submit comments on the draft renewal report.

                     (10)

                     It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

                     (11)

                     It is therefore appropriate to renew the approval of trifloxystrobin.

                     (12)

                     The risk assessment for the renewal of the approval of trifloxystrobin is based on a limited number of representative uses, which, however, do not restrict the uses for which plant protection products containing trifloxystrobin may be authorised. It is therefore appropriate not to maintain the restriction for use only as a fungicide.

                     (13)

                     In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.

                     (14)

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

                     (15)

                     Taking into account that the current approval of trifloxystrobin expires on 31 July 2018, this Regulation should enter into force as soon as possible.

                     (16)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Renewal of the approval of active substance
            The approval of the active substance trifloxystrobin is renewed as set out in Annex I.

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

            Article 3
            Entry into force and date of application
            This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
            It shall apply from 1 August 2018.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 26 July 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Directive 2003/68/EC of 11 July 2003 amending Council Directive 91/414/EEC to include trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone and isoxaflutole as active substances (OJ L 177, 16.7.2003, p. 12).

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

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

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

            (6)  EFSA Journal 2017;15(9):4980. Available online: www.efsa.europa.eu.

            ANNEX I

                        Common Name, Identification Numbers

                        IUPAC Name

                        Purity (1)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                        Trifloxystrobin
                        CAS No 141517-21-7
                        CIPAC No 617

                        methyl (E)-methoxyimino-{(E)-α-[1-(α,α,α-trifluoro-m-tolyl)ethylideneaminooxyl]-o-tolyl}acetate

                        ≥ 975 g/kg
                        AE 1344136 (max. 4 g/kg)

                        1 August 2018

                        31 July 2033

                        For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on trifloxystrobin, and in particular Appendices I and II thereto, shall be taken into account.
                        In this overall assessment Member States shall pay particular attention to:

                                    —

                                    the protection of groundwater when the substance is applied in regions with vulnerable soil and/or climate conditions;

                                    —

                                    the protection of aquatic organisms, bees, and of fish-eating birds and mammals.

                              Conditions of use shall include risk mitigation measures, where appropriate.
                        The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

                                    (1)

                                    the relevance of metabolites that may occur in groundwater, taking into account any relevant classification for trifloxystrobin in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2), in particular as toxic for reproduction category 2;

                                    (2)

                                    the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water.

                              The applicant shall submit the information requested under point (1) within one year after the publication, on the website of the European Chemicals Agency (ECHA), of the opinion adopted by the Committee for Risk Assessment of the ECHA in accordance with Article 37(4) of Regulation (EC) No 1272/2008 with respect to trifloxystrobin.
                        The applicant shall submit the information requested under point (2) within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.

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

               (2)  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).

            ANNEX II
            The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

                        (1)

                        in Part A, the entry 59 on trifloxystrobin is deleted;

                        (2)

                        in Part B, the following entry is added:

                                    No

                                    Common Name, Identification Numbers

                                    IUPAC Name

                                    Purity (1)

                                    Date of approval

                                    Expiration of approval

                                    Specific provisions

                                    ‘124

                                    Trifloxystrobin
                                    CAS No 141517-21-7
                                    CIPAC No 617

                                    methyl (E)-methoxyimino-{(E)-α-[1-(α,α,α-trifluoro-m-tolyl)ethylideneaminooxyl]-o-tolyl}acetate

                                    ≥ 975 g/kg
                                    AE 1344136 (max. 4 g/kg)

                                    1 August 2018

                                    31 July 2033

                                    For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on trifloxystrobin, and in particular Appendices I and II thereto, shall be taken into account.
                                    In this overall assessment Member States shall pay particular attention to:

                                                —

                                                the protection of groundwater when the substance is applied in regions with vulnerable soil and/or climate conditions;

                                                —

                                                the protection of aquatic organisms, bees, and of fish-eating birds and mammals.

                                          Conditions of use shall include risk mitigation measures, where appropriate.
                                    The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

                                                (1)

                                                the relevance of metabolites that may occur in groundwater, taking into account any relevant classification for trifloxystrobin in accordance with Regulation (EC) No 1272/2008, in particular as toxic for reproduction category 2;

                                                (2)

                                                the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water.

                                          The applicant shall submit the information requested under point (1) within one year after the publication, on the website of the European Chemicals Agency (ECHA), of the opinion adopted by the Committee for Risk Assessment of the ECHA in accordance with Article 37(4) of Regulation (EC) No 1272/2008 with respect to trifloxystrobin.
                                    The applicant shall submit the information requested under point (2) within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.’

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


title: Commission Implementing Regulation (EU) 2018/1130 of 13 August 2018 approving cypermethrin as an existing active substance for use in biocidal products of product-type 18 (Text with EEA relevance.)

text:
                  14.8.2018

                  EN

                  Official Journal of the European Union

                  L 205/8

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1130
         of 13 August 2018
         approving cypermethrin as an existing active substance for use in biocidal products of product-type 18
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the third subparagraph of Article 89(1) thereof,
         Whereas:

                     (1)

                     Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes cypermethrin.

                     (2)

                     Cypermethrin has been evaluated for use in products of product-type 18, insecticides, acaricides and products to control other arthropods, as described in Annex V to Regulation (EU) No 528/2012.

                     (3)

                     Belgium was designated as a rapporteur Member State and its evaluating competent authority submitted the assessment report together with its recommendations on 15 April 2015.

                     (4)

                     In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 5 May 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority (3).

                     (5)

                     According to that opinion, biocidal products of product-type 18 containing cypermethrin may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.

                     (6)

                     It is therefore appropriate to approve cypermethrin for use in biocidal products of product-type 18, subject to compliance with certain specifications and conditions.

                     (7)

                     Furthermore, a need to further investigate the endocrine disrupting potential of cypermethrin has been identified in a screening study carried out in preparation of the impact assessment conducted by the Commission on various options to set criteria to identify endocrine disruptors (4). An assessment of the potential endocrine disrupting properties of cypermethrin will also be conducted in the context of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (5), and the conclusions thereof are expected before the end of 2018. Depending on the outcome of that assessment, the Commission will consider the need to review the approval of cypermethrin as active substance for use in biocidal products in accordance with Article 15 of Regulation (EU) No 528/2012.

                     (8)

                     A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

                     (9)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Cypermethrin is approved as an active substance for use in biocidal products of product-type 18, subject to the specifications and conditions set out in the 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, 13 August 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 167, 27.6.2012, p. 1.

            (2)  Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

            (3)  Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance Cypermethrin, Product type: PT 18, ECHA/BPC/153/2017, Adopted on 5 May 2017

            (4)  COM(2016) 350 final.

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

            ANNEX

                        Common Name

                        IUPAC Name
                        Identification Numbers

                        Minimum degree of purity of the active substance (1)

                        Date of approval

                        Expiry date of approval

                        Product type

                        Specific conditions

                        Cypermethrin

                        IUPAC Name:
                        Cypermethrin cis:trans 40:60; (RS)-α-cyano-3 phenoxybenzyl-(1RS)-cis,trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate
                        EC No: 257-842-9
                        CAS No: 52315-07-8

                        ≥ 92 % w/w
                        Isomeric ratio: cis:trans 40:60

                        1 June 2020

                        31 May 2030

                        18

                        The authorisations of biocidal products are subject to the following conditions:

                                    1.

                                    The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.

                                    2.

                                    In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:

                                                a)

                                                professional users;

                                                b)

                                                secondary exposure of infants and toddlers;

                                                c)

                                                surface water for:

                                                            i)

                                                            surface application indoors; and

                                                            ii)

                                                            outdoor wall and perimeter applications in urban areas;

                                                d)

                                                soil for:

                                                            i)

                                                            surface application indoors;

                                                            ii)

                                                            outdoor wall applications in urban and rural areas; and

                                                            iii)

                                                            perimeter applications in rural areas;

                                                e)

                                                sediment for:

                                                            i)

                                                            surface application, chemical barrier and crack and crevice treatment indoors; and

                                                            ii)

                                                            outdoor wall and perimeter applications in urban areas;

                                                f)

                                                groundwater for outdoor wall and perimeter applications in urban areas.

                                    3.

                                    For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (2) or Regulation (EC) No 396/2005 of the European Parliament and of the Council (3) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

               (1)  The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.

               (2)  Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).

               (3)  Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).


title: Commission Implementing Regulation (EU) 2018/1132 of 13 August 2018 authorising the change of the designation and specific labelling requirement of the novel food synthetic zeaxanthin 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:
                  14.8.2018

                  EN

                  Official Journal of the European Union

                  L 205/15

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1132
         of 13 August 2018
         authorising the change of the designation and specific labelling requirement of the novel food synthetic zeaxanthin 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) was adopted, which establishes a Union list of authorised novel foods.

                     (3)

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

                     (4)

                     Natural zeaxanthin is a component of the normal human diet as it is found in many fruits and green vegetables as well as in egg yolk. It is also currently used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3).

                     (5)

                     Commission Implementing Decision 2013/49/EU (4) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (5), the placing on the market of synthetic zeaxanthin as a novel food ingredient in food supplements at the maximum intake of up to 2 mg per day. The designation of synthetic zeaxanthin authorised by Implementing Decision 2013/49/EU on the labelling of the foodstuffs containing it is ‘synthetic zeaxanthin’.

                     (6)

                     On 23 February 2018, the company DSM Nutritional Products Europe (‘the Applicant’) made a request to the Commission to authorise the amendment of the designation and of the specific labelling requirements for synthetic zeaxanthin within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requests the deletion of the term ‘synthetic’ from the designation of the novel food as listed in the Union list and from the labelling of foodstuffs containing it.

                     (7)

                     The Applicant considers that the change of the designation and the labelling requirements of zeaxanthin is necessary to alleviate any potential negative economic impact that the use of the term ‘synthetic’ on the labelling of food supplements containing synthetic zeaxanthin may cause due to the negative connotation of the term ‘synthetic’. The Applicant also claims that such potential negative economic impact is most probably not experienced by economic operators placing on the market food supplements containing authorised synthetic novel foods which do not carry the term ‘synthetic’ on their labelling.

                     (8)

                     There are a number of synthetic substances currently authorised and listed in the Union list of novel foods, of which the counterparts from natural origin exist, and both forms are used in food supplements. However those synthetic substances are not designated as synthetic in the Union list and are not labelled as such. The change in the designation and labelling of synthetic zeaxanthin will ensure consistency with the designation and labelling of those synthetic substances.

                     (9)

                     There are no changes in the proposed uses and use levels of zeaxanthin when used as an ingredient in food supplements, the safety considerations that supported the authorisation of synthetic zeaxanthin by Implementing Decision 2013/49/EU remain valid and therefore this change does not pose any safety concerns. Taking into account these legitimate factors, the proposed changes comply with Article 12(1) of Regulation (EU) 2015/2283.

                     (10)

                     The implementation of the new labelling requirement in accordance with this Implementing Regulation might involve changes for the business operators who currently place synthetic zeaxanthin on the market. Therefore, it is appropriate to provide for a transitional period.

                     (11)

                     Directive 2002/46/EC lays down requirements on food supplements. The change of designation and of specific labelling requirement for zeaxanthin should be authorised without prejudice to that Directive.

                     (12)

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

               HAS ADOPTED THIS REGULATION:

            Article 1

               1.   The entry in the Union list of authorised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283 referring to the substance zeaxanthin shall be amended as specified in the Annex to this Regulation.

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

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

            Article 2
            The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

            Article 3
            Food supplements containing synthetic zeaxanthin and complying with Regulation (EU) 2015/2283 as applicable before the entry into force of this Regulation may be placed on the market until 3 September 2019 and may remain on the market until exhaustion of stocks.

            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, 13 August 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

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

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

            (4)  Commission Implementing Decision 2013/49/EU of 22 January 2013 authorising the placing on the market of synthetic zeaxanthin as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 21, 24.1.2013, p. 32).

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

            ANNEX
            In Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470 the entry for ‘Zeaxanthin’ is replaced by the following:

                           Authorised novel food

                           Conditions under which the novel food may be used

                           Additional specific labelling requirements

                           ‘Zeaxanthin

                              Specified food category

                              Maximum levels

                           The designation of the novel food on the labelling of the foodstuffs containing it shall be “Zeaxanthin”.’

                           Food Supplements as defined in Directive 2002/46/EC

                           2 mg/day