title: Commission Implementing Regulation (EU) 2018/520 of 28 March 2018 amending Regulation (EU) No 37/2010 to classify the substance solvent naphtha, light aromatic, as regards its maximum residue limit (Text with EEA relevance. )

text:
               3.4.2018

               EN

               Official Journal of the European Union

               L 87/9

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/520
   of 28 March 2018
   amending Regulation (EU) No 37/2010 to classify the substance solvent naphtha, light aromatic, as regards its maximum residue limit
   (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 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 the Council (1), and in particular Article 14 in conjunction with Article 17 thereof,
   Having regard to the opinion of the European Medicines Agency formulated by the Committee for Medicinal Products for Veterinary Use,
   Whereas:

               (1)

               Article 17 of Regulation (EC) No 470/2009 requires that the maximum residue limit (‘MRL’) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry is established in a Regulation.

               (2)

               Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin.

               (3)

               The substance solvent naphtha, light aromatic, is not included in that table.

               (4)

               An application for the establishment of MRLs for solvent naphtha, light aromatic, in all food producing species has been submitted to the European Medicines Agency (‘EMA’).

               (5)

               EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use, has recommended that the establishment of an MRL for solvent naphtha, light aromatic, in all food producing species is not necessary for the protection of human health.

               (6)

               According to Article 5 of Regulation (EC) No 470/2009, EMA is to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for other species.

               (7)

               EMA has considered that the extrapolation of the ‘no MRL required’ classification for solvent naphtha, light aromatic, is not applicable as the recommendation is for all food producing species.

               (8)

               Regulation (EU) No 37/2010 should therefore be amended accordingly.

               (9)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   The Annex to Regulation (EU) No 37/2010 is amended as set out in the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 28 March 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 152, 16.6.2009, p. 11.

      (2)  Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).

      ANNEX
      In Table 1 of the Annex to Regulation (EU) No 37/2010, an entry for the following substance is inserted in alphabetical order:

                     Pharmacologically active Substance

                     Marker residue

                     Animal Species

                     MRL

                     Target Tissues

                     Other Provisions (according to Article 14(7) of Regulation (EC) No 470/2009)

                     Therapeutic Classification

                     ‘Solvent naphtha, light aromatic, with cumene concentration not exceeding 2,5 %, and benzene concentration not exceeding 0,0002 %

                     NOT APPLICABLE

                     All food producing species

                     No MRL required

                     NOT APPLICABLE

                     For cutaneous use only.
                     Only at volume not exceeding 15 μl solvent naphtha/kg bw

                     NO ENTRY’


title: Commission Implementing Regulation (EU) 2018/523 of 28 March 2018 amending Regulation (EU) No 37/2010 to classify the substance fluazuron as regards its maximum residue limit (Text with EEA relevance. )

text:
               4.4.2018

               EN

               Official Journal of the European Union

               L 88/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/523
   of 28 March 2018
   amending Regulation (EU) No 37/2010 to classify the substance fluazuron as regards its maximum residue limit
   (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 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 the Council (1), and in particular Article 14 in conjunction with Article 17 thereof,
   Having regard to the opinion of the European Medicines Agency formulated by the Committee for Medicinal Products for Veterinary Use,
   Whereas:

               (1)

               Article 17 of Regulation (EC) No 470/2009 requires that the maximum residue limit (‘MRL’) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry is established in a Regulation.

               (2)

               Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin.

               (3)

               Fluazuron is already included in that table as an allowed substance for bovine species, applicable to muscle, fat, liver and kidney, excluding animals producing milk for human consumption.

               (4)

               An application for the extension of the existing entry for fluazuron to fin fish has been submitted to the European Medicines Agency (‘EMA’).

               (5)

               The EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use, has recommended the establishment of an MRL for fluazuron in fin fish.

               (6)

               According to Article 5 of Regulation (EC) No 470/2009, EMA is to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for other species.

               (7)

               The EMA has considered that the extrapolation of the entry for fluazuron to tissues of all ruminants except ovine species and to bovine milk is appropriate.

               (8)

               Regulation (EU) No 37/2010 should therefore be amended accordingly.

               (9)

               It is appropriate to grant the stakeholders concerned a reasonable period of time to take measures that may be required to comply with the new MRL.

               (10)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   The Annex to Regulation (EU) No 37/2010 is amended as set out in the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   It shall apply from 3 June 2018.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 28 March 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 152, 16.6.2009, p. 11.

      (2)  Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).

      ANNEX
      In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance ‘fluazuron’ is replaced by the following:

                     Pharmacologically active Substance

                     Marker residue

                     Animal Species

                     MRLs

                     Target Tissues

                     Other Provisions (according to Article 14(7) of Regulation (EC) No 470/2009)

                     Therapeutic Classification

                     ‘Fluazuron

                     Fluazuron

                     All ruminants except bovine and ovine

                     200 μg/kg

                     Muscle

                     Not for use in animals from which milk is produced for human consumption

                     Antiparasitic agents/Agents (acting) against ectoparasites’

                     7 000  μg/kg

                     Fat

                     500 μg/kg

                     Liver

                     500 μg/kg

                     Kidney

                     Bovine

                     200 μg/kg

                     Muscle

                     NO ENTRY

                     7 000  μg/kg

                     Fat

                     500 μg/kg

                     Liver

                     500 μg/kg

                     Kidney

                     200 μg/kg

                     Milk

                     Fin fish

                     200 μg/kg

                     Muscle and skin in natural proportions

                     NO ENTRY


title: Commission Implementing Regulation (EU) 2018/613 of 20 April 2018 approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 2 and 4 (Text with EEA relevance. )

text:
               23.4.2018

               EN

               Official Journal of the European Union

               L 102/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/613
   of 20 April 2018
   approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 2 and 4
   (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 PHMB (1415; 4.7).

               (2)

               PHMB (1415; 4.7) has been evaluated for use in products of product-type 2, disinfectants and algaecides not intended for direct application to humans or animals, and product-type 4, food and feed area, as described in Annex V to Regulation (EU) No 528/2012.

               (3)

               France was designated as evaluating competent authority and submitted the assessment reports together with its recommendations on 13 December 2016.

               (4)

               In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 4 October 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

               (5)

               According to those opinions, biocidal products of product-types 2 and 4 containing PHMB (1415; 4.7) 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 PHMB (1415; 4.7) for use in biocidal products of product-types 2 and 4, subject to compliance with certain specifications and conditions.

               (7)

               The opinions conclude that PHMB (1415; 4.7) meets the criteria for being a very persistent (vP) and toxic (T) substance in accordance with Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3). PHMB (1415; 4.7) therefore meets the conditions set out in point (d) of Article 10(1) of Regulation (EU) No 528/2012 and should be considered a candidate for substitution.

               (8)

               Pursuant to Article 10(4) of that Regulation, the approval of an active substance that is considered as a candidate for substitution should be for a period not exceeding 7 years.

               (9)

               For the use in product-type 4, the evaluation did not address the incorporation of biocidal products containing PHMB (1415; 4.7) in materials and articles intended to come into contact directly or indirectly with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004 of the European Parliament and of the Council (4). Such materials may require the establishment of specific limits on the migration into food, as referred to in Article 5(1)(e) of Regulation (EC) No 1935/2004. The approval should therefore not cover such use unless the Commission has established such limits or it has been established pursuant to that Regulation that such limits are not necessary.

               (10)

               Since PHMB (1415; 4.7) meets the criteria for being very persistent (vP) according to Annex XIII to Regulation (EC) No 1907/2006, treated articles treated with or incorporating PHMB (1415; 4.7) should be appropriately labelled when placed on the market.

               (11)

               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.

               (12)

               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
   PHMB (1415; 4.7) is approved as an active substance for use in biocidal products of product-types 2 and 4, 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, 20 April 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)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

      (4)  Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).

      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

                  PHMB (1415; 4.7) (polyhexamethylene biguanide hydrochloride with a mean number-average molecular weight (Mn) of 1415 and a mean polydispersity (PDI) of 4.7)

                  IUPAC Name:
                  CoPoly(bisiminoimidocarbonyl, hexamethylene hydrochloride),(iminoimidocarbonyl, hexamethylene hydrochloride)
                  EC No: not available
                  CAS No: 32289-58-0 and 1802181-67-4

                  943g/kg (calculated dry weight specification).
                  The active substance as manufactured is an aqueous solution of 20 % w/w of PHMB (1415; 4.7)

                  1 November 2019

                  31 October 2026

                  2

                  PHMB (1415; 4.7) is considered a candidate for substitution in accordance with point (d) of Article 10(1) Regulation (EU) No 528/2012.
                  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)

                                          non-professional users;

                                          (c)

                                          secondary exposure of the general public and toddlers;

                                          (d)

                                          environment: surface water, sediment and soil.

                        The placing on the market of treated articles is subject to the following condition:
                  The person responsible for the placing on the market of a treated article treated with or incorporating PHMB (1415; 4.7) shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.

                  4

                  PHMB (1415; 4.7) is considered a candidate for substitution in accordance with point (d) of Article 10(1) Regulation (EU) No 528/2012.
                  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)

                                          non-professional users;

                                          (c)

                                          secondary exposure of the general public;

                                          (d)

                                          environment: surface water, sediment and soil;

                              (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;

                              (4)

                              products shall not be incorporated in materials and articles intended to come into contact with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004, unless the Commission has established specific limits on the migration of PHMB (1415; 4.7) into food or it has been established pursuant to that Regulation that such limits are not necessary.
                              The placing on the market of treated articles is subject to the following condition:
                              the person responsible for the placing on the market of a treated article treated with or incorporating PHMB (1415; 4.7) shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.

         (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) 2018/671 of 2 May 2018 making imports of electric bicycles originating in the People's Republic of China subject to registration

text:
               3.5.2018

               EN

               Official Journal of the European Union

               L 113/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/671
   of 2 May 2018
   making imports of electric bicycles originating in the People's Republic of China subject to registration
   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 anti-dumping Regulation’), and in particular Article 14(5) thereof,
   Having regard to Regulation (EU) 2016/1037 of the European Parliament and of the Council of 8 June 2016 on protection against subsidised imports from countries not members of the European Union (2) (‘the basic anti-subsidy Regulation’), and in particular Article 24(5) thereof,
   After informing the Member States,
   Whereas:

               (1)

               On 20 October 2017, the European Commission (‘the Commission’) announced, by a notice published in the Official Journal of the European Union
                   (3) (‘the AD notice of initiation’), the initiation of an anti-dumping proceeding (‘the anti-dumping proceeding’) with regard to imports into the Union of electric bicycles originating in the People's Republic of China (‘PRC’) following a complaint lodged on 8 September 2017 by the European Bicycle Manufacturers Association (‘the complainant’ or ‘EBMA’) on behalf of producers representing more than 25 % of the total Union production of electric bicycles.

               (2)

               On 21 December 2017, the Commission announced, by a notice published in the Official Journal of the European Union
                   (4) (‘the AS notice of initiation’), the initiation of an anti-subsidy proceeding (‘the anti-subsidy proceeding’) with regard to imports into the Union of electric bicycles originating in the PRC following a complaint lodged on 8 November 2017 by the complainant on behalf of producers representing more than 25 % of the total Union production of electric bicycles.

         1.   PRODUCT CONCERNED AND LIKE PRODUCT

               (3)

               The product subject to registration (‘the product concerned’) for both proceedings is cycles, with pedal assistance, with an auxiliary electric motor, originating in the PRC, currently falling within CN codes 8711 60 10 and ex 8711 60 90 (TARIC code 8711609010). These CN and TARIC codes are given for information only.

         2.   REQUEST

               (4)

               The complainant indicated in its complaints its intention to request registration. On 31 January 2018, the complainant submitted registration requests pursuant to Article 14(5) of the basic anti-dumping Regulation and Article 24(5) of the basic anti-subsidy Regulation. The complainant requested that imports of the product concerned be made subject to registration so that measures may subsequently be applied against those imports from the date of such registration, provided all conditions set out in the basic Regulations are met.

         3.   GROUNDS FOR REGISTRATION

               (5)

               According to Article 14(5) of the basic anti-dumping Regulation and Article 24(5) of the basic anti-subsidy Regulation, the Commission may direct the customs authorities to take the appropriate steps to register imports, so that measures may subsequently be applied against those imports from the date of such registration, provided all conditions set out in the basic Regulations are met. Imports may be made subject to registration following a request from the Union industry, which contains sufficient evidence to justify such action.

               (6)

               According to the complainant, registration is justified as the product concerned is being dumped and subsidised. Significant injury to the Union industry, is being caused by an acceleration of low-priced imports which will undermine the remedial effect of potential definitive duties by allowing stockpiling ahead of the 2018 selling season.

               (7)

               The Commission examined the request in the light of Article 10(4) of the basic anti-dumping Regulation and Article 16(4) of the basic anti-subsidy Regulation.

               (8)

               With respect to the dumping part of the request, the Commission verified whether the importers were aware, or should have been aware, of the dumping as regards the extent of the dumping and the injury alleged or found. It also analysed whether there was a further substantial rise in imports which, in the light of its timing and volume and other circumstances, is likely to seriously undermine the remedial effect of the definitive anti-dumping duty to be applied.

               (9)

               With respect to the subsidy part of the request, the Commission verified whether there are critical circumstances where, for the subsidised product in question, injury which is difficult to repair is caused by massive imports in a relatively short period of a product benefitting from countervailable subsidies and whether it is deemed necessary to assess countervailing duties retroactively on those imports in order to preclude the recurrence of such injury.

         3.1.   Awareness of the importers of the dumping, the extent thereof and the alleged injury

               (10)

               As regards dumping, at this stage, the Commission has at its disposal sufficient evidence that imports of the product concerned from the PRC are being dumped. In particular, the complainant provided evidence on the normal value based on domestic prices and based on the choice of Switzerland according to Article 2(7) of the basic anti-dumping Regulation.

               (11)

               The evidence of dumping is based on a comparison of the normal value thus established with the export price (at ex-works level) of the product concerned when sold for export to the Union. As a whole, and given the extent of the alleged dumping margins ranging from 193 % to 430 %, this evidence provides sufficient support at this stage that the exporting producers practice dumping.

               (12)

               That information was contained in the notice of initiation for this proceeding published on 20 October 2017.

               (13)

               Giant, an exporting producer with a related importer, claimed that the initiation of an anti-dumping investigation was not sufficient to establish awareness of dumping.

               (14)

               By its publication in the Official Journal of the European Union, the notice of initiation is a public document accessible to all importers. Furthermore, as interested parties in the investigation, importers have access to the non-confidential version of the complaint. Therefore, the Commission considered that the importers were aware, or should have been aware, of the alleged dumping practices, the extent thereof and the alleged injury at the latest at that moment.

               (15)

               The same interested party claimed that an importer could not be expected to be aware of the application of Article 2(7) of the basic anti-dumping Regulation and even less able to anticipate the normal value against which Chinese export prices into the Union should be assessed.

               (16)

               The Commission noted that the application of Article 2(7) of the basic anti-dumping Regulation was mentioned in the complaint and also referred to it in the notice of initiation.

               (17)

               The complaint also provided sufficient evidence of alledged injury showing a steep decline of the market share of the Union Industry from 42,5 % in 2014 to 28,6 % in the period used for the complaint, depressed and declining levels of profitability from 3,4 % of turnover in 2014 to 2,1 % in the period used for the complaint as well as underselling calculations ranging from 153 % to 206 %.

               (18)

               The Commission thus concluded that the first criterion for registration was met with respect to the dumping part of the request.

         3.2.   Further substantial rise in imports

               (19)

               Eurostat data do not allow a full analysis of the evolution of imports of electric bicycles into the Union. Indeed, while the investigation period starts in October 2016, an estimated 99 % of imports of electric bicycles were classified until January 2017 under a CN code which covered other products.

               (20)

               In this context, the complainant provided detailed figures based on the export data of the Chinese customs from January 2014 until February 2018. Based on submissions from interested parties and a reconciliation of statistics, the Commission considered that there is a delay of two months between exports from the PRC and imports into the Union.

               (21)

               In its analysis, the Commission therefore considered that the Chinese customs' export data provided sufficient prima facie evidence of imports into the Union with a two-month delay for shipment. To determine the amount of imports during the investigation period (i.e. 1 October 2016 - 30 September 2017), the Commission thus used the Chinese export data between August 2016 and July 2017.

               (22)

               The volume of exports from the PRC to the Union increased by 82 % in the period from November 2017 to February 2018 when compared to the period from November 2016 to February 2017. In addition, the average monthly volume of exports from the PRC to the Union in the period from November 2017 to February 2018 was 64 % higher than the average monthly volume of imports to the Union during the investigation period. The Commission considered that these figures provided evidence of a substantial increase in imports.

               (23)

               Some unrelated importers and Giant claimed that the raw Chinese export data relied upon by the complainant to support its request for registration should be disclosed in the non-confidential file in order to ensure the reliability of the source and of the data supplied. Importers claim that the codes used were not mentioned and could include other products.

               (24)

               The complainant made available to the Commission the detailed statistics used to support its request. The disclosure of these data would breach copyrights. However, the complainant made available in the non-confidential version of the request the aggregated export figures per month and per year. The complainant also indicated that the source was the Chinese customs, mentioned the codes used and explained its methodology to exclude other products than the product concerned. As such, the source was known and public against payment. Furthermore, these data were broadly corroborated by Eurostat for the period available. No other interested party proposed alternative data or methodology. In these circumstances and given the level of disclosure of aggregated data and methodology on the non-confidential file, the Commission considers that the input data is not necessary for the party concerned to exercise their rights of defence. This argument had therefore to be rejected.

               (25)

               Some unrelated importers further argued that stockpiling was not possible due to long lead times between design and delivery. In this regard, the Commission considered that the lead-time from designing an electric bicycle to actual delivery did not prevent the possibility of stockpiling an already designed electric bicycle, especially considering the information contained in the complaint concerning spare capacities in the PRC. Furthermore, the available statistical evidence supported the claim that there was a substantial rise in imports. The argument was therefore rejected.

               (26)

               Some unrelated importers and Giant denied that the increase in Chinese exports provided evidence of a further substantial rise in imports and claimed that it reflected the seasonality of the sales of electric bicycles. The Commission considered that a year-on-year comparison was not influenced by seasonality effects and provided evidence of a rise of 82 % in the volume of imports since the initiation of the case. The argument was therefore rejected.

               (27)

               Giant denied that the rise of imports was substantial and claimed that it was below or in line with the overall growth in Union demand for electric bicycles. Giant quoted the publications of the Confederation of the European Bicycle Industry (‘CONEBI’) which estimated this growth to be 22,2 % in 2016 in comparison with 2015, and of EBMA, the complainant, which estimated the growth rate for 2017 at 23 % in comparison with 2016. Giant claimed that October 2017 was the proper starting point to assess the increase in imports. Giant calculated that based on Eurostat import data, monthly imports of electric bicycles had increased by 8,7 % between October 2017 and January 2018.

               (28)

               The Commission notes that Giant submitted that the shipment time between exports from the PRC and imports into the Union was ‘at least one or two months’. As a result, the imports in October 2017 corresponded to the exports from the PRC made in August 2017, before the initiation of the investigation. In addition, the average monthly volume of exports from the PRC to the Union in the period from August 2017 to February 2018 was 36 % higher than the average monthly volume of imports to the Union during the investigation period. This growth rate does not take into account the very significant increase of imports which had already occurred during the investigation period and is nevertheless well above the 2016 and 2017 growth rates in the Union market demand.

               (29)

               Therefore, the Commission concluded that the second criterion for registration for the dumping part of the request was also met.

         3.3.   Undermining of the remedial effect of the duty

               (30)

               The Commission has at its disposal sufficient evidence that additional injury would be caused by a continued rise in imports from the PRC at further decreasing prices.

               (31)

               As established in recitals (19) to (29), there is sufficient evidence of a substantial rise in imports of the product concerned.

               (32)

               In addition, there is evidence of a decreasing trend in the import prices of the product concerned. The average price in euros of imports from the PRC into the Union was indeed 8 % lower in the period from November 2017 to February 2018 than in the period from November 2016 to February 2017 and 7 % lower when compared to the investigation period.

               (33)

               Additional circumstances show that the further substantial rise in imports is likely to seriously undermine the remedial effect of the duties to be applied. It is indeed reasonable to assume that the imports of the product concerned may further increase prior to the adoption of provisional measures, if any, since the latter would occur at the latest around the 20th of July which would coincide with the end of the 2018 selling season of electric bicycles.

               (34)

               Such further rise in imports following the initiation of the case is thus likely, in light of its timing, volume and other circumstances (such as the excess capacity in the PRC and pricing behaviour of Chinese exporting producers) to seriously undermine the remedial effect of any definitive duty, unless such duty would be applied retroactively.

               (35)

               The Commission therefore concluded that the third criterion for registration for the dumping part of the request was also met.

         3.4.   Injury, which is difficult to repair, is caused by massive imports of a subsidised product in a relatively short period

               (36)

               As regards subsidisation, the Commission has at its disposal sufficient evidence that imports of the product concerned from the PRC are being subsidised. The alleged subsidies consist, inter alia, of (i) direct transfer of funds and liabilities, such as grants, preferential loans, directed credits by state-owned banks as well as private banks, as well as export credits and guarantees and export insurance; (ii) government revenue forgone or not collected, such as income tax reductions and exemptions, import tariff rebates, withholding tax reductions and VAT exemptions and rebates; and (iii) government provision of input materials and land and energy for less than adequate remuneration. Such evidence was made available in the open version of the complaint and in the memorandum on sufficient evidence.

               (37)

               It is alleged that the above schemes are subsidies since they involve a financial contribution from the Government of the PRC or other regional governments (including public bodies) and confer a benefit to the exporting producers of the product concerned. They are alleged to be contingent upon export performance and/or the use of domestic over imported goods and/or are limited to certain sectors and/or types of enterprises and/or locations, and are therefore specific and countervailable.

               (38)

               Therefore, the available evidence at this stage shows that the exports of the product concerned are benefiting from countervailable subsidies.

               (39)

               Furthermore, the Commission has at its disposal sufficient evidence that the exporting producers' subsidy practices are causing material injury to the Union industry. In the complaint and the subsequent submissions related to the requests for registration, the evidence regarding the volume of imports shows a massive increase of imports in absolute terms and in terms of market share in the period between 2014 and the investigation period as well as in recent months. Specifically, the evidence available shows that Chinese exporting producers have more than tripled the volume of the product concerned exported to the Union, from 219 thousand units to 703 thousand units (+ 484 thousand units), which resulted in a sharp increase of market share from 19,2 % to 33 %. Furthermore, as indicated in recital (22) above, the same trend continued between November 2017 and February 2018. Overall, the evidence shows that the massive increase of imports of electric bicycles from the PRC is resulting in substantial adverse effects on the situation of the Union industry including depressed levels of profitability. The evidence concerning the injury factors set out in Article 3(5) of the basic anti-dumping Regulation and Article 8(4) of the basic anti-subsidy Regulation consists of data contained in the complaints and the subsequent submissions regarding registration.

               (40)

               In addition, the Commission assessed at this stage whether the injury suffered was difficult to repair. Once Chinese suppliers are integrated into the supply chains of the customers of the Union industry, the latter may be reluctant to switch suppliers in favour of Union producers. In addition, the customers of the Union Industry are unlikely to accept higher prices from the Union industry even if, hypothetically, the Commission were to impose countervailing measures without retroactive effect in the future. Such threat of permanent loss of market share or reduced income constitutes an injury which is difficult to repair.

         3.5.   Preclusion of recurrence of injury

               (41)

               Finally, given the data set out in recital (39) and the considerations laid down in recital (40), the Commission deemed it necessary to prepare the potential retroactive imposition of measures by imposing registration in order to preclude the recurrence of such injury.

         4.   PROCEDURE

               (42)

               Therefore, the Commission has concluded that there is sufficient evidence to justify making the imports of the product concerned subject to registration in accordance with Article 14(5) of the basic anti-dumping Regulation and with Article 24(5) of the basic anti-subsidy Regulation.

               (43)

               All interested parties are invited to make their views known in writing and to provide supporting evidence. Furthermore, the Commission may hear interested parties, provided that they make a request in writing and show that there are particular reasons why they should be heard.

         5.   REGISTRATION

               (44)

               Pursuant to Article 14(5) of the basic anti-dumping Regulation and Article 24(5) of the basic anti-subsidy Regulation imports of the product concerned should be made subject to registration for the purpose of ensuring that, should the investigations result in findings leading to the imposition of anti-dumping and/or countervailing duties, those duties can, if the necessary conditions are fulfilled, be levied retroactively on the registered imports in accordance with the applicable legal provisions.

               (45)

               Any future liability would emanate from the findings of the anti-dumping and the anti-subsidy investigations respectively.

               (46)

               The allegations in the complaint requesting the initiation of an anti-dumping investigation estimate an average dumping margin of from 193 % to 430 % and an average injury elimination level of 189 % for the product concerned. The amount of possible future liability is set at the level of the injury elimination level estimated on the basis of the complaint, namely 189 % ad valorem on the CIF import value of the product concerned.

               (47)

               At this stage of the investigation is not yet possible to estimate the amount of subsidisation.The allegations in the complaint requesting the initiation of an anti-subsidy investigation estimate the injury elimination level to represent 189 % for the product concerned. The amount of possible future liability is set at the level of the injury elimination level estimated on the basis of the anti-subsidy complaint, namely 189 % ad valorem on the CIF import value of the product concerned.

         6.   PROCESSING OF PERSONAL DATA

               (48)

               Any personal data collected in the context of this registration will be treated in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (5),

         HAS ADOPTED THIS REGULATION:
   Article 1
   1.   The customs authorities are hereby directed, pursuant to Article 14(5) of Regulation (EU) 2016/1036 and Article 24(5) of Regulation (EU) 2016/1037, to take the appropriate steps to register imports into the Union of cycles, with pedal assistance, with an auxiliary electric motor, currently falling within CN codes 8711 60 10 and ex 8711 60 90 (TARIC code 8711609010) and originating in the People's Republic of China.
   2.   Registration shall expire nine months following the date of entry into force of this Regulation.
   3.   All interested parties are invited to make their views known in writing, to provide supporting evidence or to request to be heard within 21 days from the date of publication of 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, 2 May 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  OJ L 176, 30.6.2016, p. 55.

      (3)  OJ C 353, 20.10.2017, p. 19.

      (4)  OJ C 440, 21.12.2017, p. 22.

      (5)  OJ L 8, 12.1.2001, p. 1.


title: Commission Implementing Regulation (EU) 2018/693 of 7 May 2018 establishing the derogation from Council Regulation (EC) No 1967/2006 as regards the prohibition to fish above protected habitats, the minimum distance from the coast and the minimum sea depth for the ‘gangui’ trawlers fishing in certain territorial waters of France (Provence-Alpes-Côte d'Azur)

text:
               8.5.2018

               EN

               Official Journal of the European Union

               L 117/13

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/693
   of 7 May 2018
   establishing the derogation from Council Regulation (EC) No 1967/2006 as regards the prohibition to fish above protected habitats, the minimum distance from the coast and the minimum sea depth for the ‘gangui’ trawlers fishing in certain territorial waters of France (Provence-Alpes-Côte d'Azur)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1967/2006 of 21 December 2006 concerning management measures for the sustainable exploitation of fishery resources in the Mediterranean Sea, amending Regulation (EEC) No 2847/93 and repealing Regulation (EC) No 1626/94 (1), and in particular Article 4(5) and Article 13(5) and (10) thereof,
   Whereas:

               (1)

               Article 4(1) of Regulation (EC) No 1967/2006 prohibits fishing with trawl nets, dredges, purse seines, boat seines, shore seines or similar nets above seagrass beds of, in particular, Posidonia oceanica or other marine phanerogams.

               (2)

               At the request of a Member State, the Commission may allow a derogation from Article 4(1) of Regulation (EC) No 1967/2006, provided that a number of conditions set out in Article 4(5) are fulfilled.

               (3)

               Article 13(1) of Regulation (EC) No 1967/2006 prohibits the use of towed gears within 3 nautical miles of the coast or within the 50 m isobath where that depth is reached at a shorter distance from the coast.

               (4)

               At the request of a Member State, the Commission may allow a derogation from Article 13(1) of Regulation (EC) No 1967/2006, provided that a number of conditions set out in Article 13(5) and (9) are fulfilled.

               (5)

               On 18 May 2011 the Commission received a request from France for a derogation from the first subparagraph of Article 4(1), from the first subparagraph of Article 13(1) and from Article 13(2) of that Regulation, for the use of ‘gangui’ trawlers in certain sea areas situated within the territorial waters of France, above seagrass beds of Posidonia oceanica and within 3 nautical miles from the coast, irrespective of the depth.

               (6)

               The derogation requested by France complied with the conditions laid down in Article 4(5) and Article 13(5) and (9) of Regulation (EC) No 1967/2006 and was granted until 6 June 2017 by Commission Implementing Regulation (EU) No 586/2014 (2).

               (7)

               On 16 June 2017 the Commission received a request from France for derogations beyond 6 June 2017. France provided up-to-date information and data to justify the derogations, including the implementation report of the management plan adopted by France on 13 May 2014 (3).

               (8)

               The request concerns fishing activities by vessels of less than or equal to 12 metres overall length and engine power of less than or equal to 85 kW with bottom-towed nets traditionally undertaken on Posidonia beds, in accordance with the first subparagraph of Article 4(5) of Regulation (EC) No 1967/2006.

               (9)

               The Scientific, Technical and Economic Committee for Fisheries (STECF) assessed the derogations requested by France and the implementation report concerned during its 55th plenary session held in July 2017. Additional data and clarifications submitted by France were assessed by the STECF in its 56th plenary session held in November 2017. STECF concluded that the data submitted by the French authorities were not sufficient and needed to be improved. Following that, France provided adequate clarifications to the Commission. The current characteristics of the ‘gangui’ trawlers do not allow providing complete data of the activities thereof, since the small-scale vessels are exempt from certain provisions of the Community control system, such as the fishing logbook data and Vessel Monitoring System. France justified the derogations requested with the scientific and technical data it provided as regards requirements of Regulation (EC) No 1967/2006. France further adopted specific measures, including a complete set of new control and monitoring measures of gangui fisheries, which will allow to confirm the assessment of the use of ‘gangui’ trawlers. Those measures are provided for by the national Decree (4) adopted on 16 March 2018.

               (10)

               France should provide, based on scientific and technical data, the updated mapping of Posidonia seagrass beds and a yearly report as regards the implementation of the additional control and monitoring measures and as regards compliance with the requirements for granting the derogations concerned, including information on all necessary measures adopted. On that basis, the Commission considers that the derogations requested by France may be considered complying with the conditions set out in Article 4(5) and in Article 13(5) and (9) of Regulation (EC) No 1967/2006.

               (11)

               The fishing activities concerned affect approximately 15 % of the area covered by seagrass beds of Posidonia oceanica within the area covered by the French management plan and 5,8 % of seagrass beds in the territorial waters of France, in line with the ceilings established under requirements of points (ii) and (iii) of the first subparagraph of Article 4(5) of Regulation (EC) No 1967/2006.

               (12)

               There are specific geographical constraints given the limited size of the continental shelf.

               (13)

               The fishery has no significant impact on the marine environment.

               (14)

               The fishery conducted with ‘gangui’ trawlers target a variety of species which correspond to an ecological niche; the catch composition of this fishery, in particular as regards the number of species caught, is not reflected in any other fishing gear. Therefore, the fishery cannot be undertaken with other gears.

               (15)

               The derogations requested by France affect a limited number of only 24 vessels. This represents a very significant reduction of the fishing effort in terms of a number of vessels, where in 2014 the fisheries concerned 36 vessels.

               (16)

               The management plan guarantees no future increase in the fishing effort, as fishing authorisations will be issued to specified 24 vessels involving a total of 1 136 kW that are already authorised to fish by France. The Commission also takes into consideration that according to France the fishing effort in terms of number of vessels will gradually be reduced.

               (17)

               The request covers vessels with a track record in the fishery of more than five years and which operate under the French management plan in accordance with Article 19(2) of Regulation (EC) No 1967/2006.

               (18)

               Those vessels are included on a list communicated to the Commission in line with Article 13(9) of Regulation (EC) No 1967/2006.

               (19)

               The fishing activities concerned fulfil the requirements of Article 4, Article 8(1)(h) and Article 9(3) of Regulation (EC) No 1967/2006.

               (20)

               The management plan includes measures for the monitoring of fishing activities, thus fulfilling the conditions set out in Article 14 of Council Regulation (EC) No 1224/2009 (5).

               (21)

               The fishing activities concerned do not interfere with the activities of vessels using gears other than trawls, seines or similar towed nets.

               (22)

               The activity of ‘gangui’ trawlers is regulated in the French management plan to ensure that catches of species mentioned in Annex III of Regulation (EC) No 1967/2006 are minimal.

               (23)

               ‘Gangui’ trawlers do not target cephalopods.

               (24)

               The French management plan includes measures for the monitoring of fishing activities, as provided for in the fifth subparagraph of Article 4(5) and in the third subparagraph of Article 13(9) of Regulation (EC) No 1967/2006.

               (25)

               The requested derogations should therefore be granted.

               (26)

               France should report to the Commission in due time and in accordance with the monitoring plan provided for in the French management plan.

               (27)

               The duration of the derogation should be limited in order to allow prompt corrective management measures in case the report to the Commission shows a poor conservation status of the exploited stock, while providing scope to enhance the scientific basis for an improved management plan.

               (28)

               The measures provided for in the Regulation are in accordance with the opinion of the Committee for Fisheries and Aquaculture,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Derogation
   Article 4(1) and Article 13(1) and (2) of Regulation (EC) No 1967/2006 shall not apply in the territorial waters of France adjacent to the coast of the Provence-Alpes-Côte d'Azur region to ‘gangui’ trawlers:

               (a)

               bearing a registration number mentioned in the French management plan adopted by France in accordance with Article 19 of Regulation (EC) No 1967/2006;

               (b)

               having a track record in the fishery of more than five years and not involving any future increase in fishing effort provided; and

               (c)

               holding a fishing authorisation and operating under the French management plan.

         Article 2
   Reporting
   France shall communicate to the Commission, within two years following the entry into force of this Regulation, a report drawn up in accordance with the monitoring plan established in the French management plan referred to in Article 1.
   By June of each year following the entry into force of this Regulation and by June 2019 for the first time, France shall submit to the Commission a report, based on scientific and technical data, on the implementation of the additional control and monitoring measures and on the compliance with the requirements for granting the derogations provided for by this Regulation.
   Article 3
   Entry into force
   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 11 May 2018 until 11 May 2020.

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

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 36, 8.2.2007, p. 6.

      (2)  Commission Implementing Regulation (EU) No 586/2014 of 2 June 2014 establishing a derogation from Council Regulation (EC) No 1967/2006 as regards the prohibition to fish above protected habitats and the minimum distance from the coast and depth for the ‘gangui’ trawlers fishing in certain territorial waters of France (Provence-Alpes-Côte d'Azur) (OJ L 164, 3.6.2014, p. 10).

      (3)  Arrêté du 13 mai 2014 portant adoption de plans de gestion pour les activités de pêche professionnelle à la senne tournante coulissante, à la drague, à la senne de plage et au gangui en mer Méditerranée par les navires battant pavillon français. Reference JORF no 0122, 27.5.2014, p. 8669.

      (4)  ‘Arrêté du 16 mars 2018 définissant un plan de contrôle et de suivi des débarquements pour les navires titulaires d'une autorisation européenne de pêche au gangui’. Reference JORF no 0069 of 23 March 2018, texte no 43.

      (5)  Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1).


title: Commission Implementing Regulation (EU) 2018/691 of 7 May 2018 approving the basic substance Talc E553B 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:
                  8.5.2018

                  EN

                  Official Journal of the European Union

                  L 117/6

            COMMISSION IMPLEMENTING REGULATION (EU) 2018/691
      of 7 May 2018
      approving the basic substance Talc E553B 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 23(5) in conjunction with Article 13(2) thereof,
      Whereas:

                  (1)

                  In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 23 July 2015 an application from Compo Expert France SAS, for the approval of Talc E553B as a basic substance. That application was accompanied by the information required by the second subparagraph of Article 23(3).

                  (2)

                  The Commission asked the European Food Safety Authority (hereinafter ‘the Authority’) for scientific assistance. The Authority presented to the Commission a Technical Report on Talc E553B on 6 June 2016 (2). Considering the additional documentation submitted by the applicant to address the comments collated through the consultation with Member States and the Authority and related to operator exposure, the Commission asked the Authority for further scientific assistance to assess the new information submitted. The Authority presented to the Commission a second Technical Report on Talc E553B on 27 July 2017 (3).

                  (3)

                  The Commission presented the draft review report (4) on 5 October 2017 and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 13 December 2017 and finalised them for the meeting of that Committee on 22 March 2018.

                  (4)

                  The documentation provided by the applicant shows that Talc E553B fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (5). Moreover, it is not predominantly used for plant protection purposes but nevertheless is useful in plant protection in a product consisting of the substance and water. Consequently, it is to be considered as a basic substance.

                  (5)

                  It has appeared from the examinations made that Talc E553B may be expected to satisfy, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve Talc E553B as a basic substance.

                  (6)

                  In accordance with Article 13(2) 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 for the approval which are detailed in Annex I to this Regulation.

                  (7)

                  In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (6) should be amended accordingly.

                  (8)

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

            HAS ADOPTED THIS REGULATION:
      Article 1
      Approval of a basic substance
      The substance Talc E553B is approved as a basic substance as laid down in Annex I.
      Article 2
      Amendments to Implementing Regulation (EU) No 540/2011
      Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
      Article 3
      Entry into force
      This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

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

               For the Commission

               The President

            Jean-Claude JUNCKER

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

         (2)  European Food Safety Authority, 2016. Technical report on the outcome of the consultation with Member States and EFSA on the basic substance application for Talc E553B for use in plant protection as repellent on fruit trees and grapevine. EFSA supporting publication 2016:EN-1044. 29 pp.

         (3)  European Food Safety Authority, 2017. Technical report on the outcome of the consultation with Member States and EFSA on the basic substance application for Talc E553B for use in plant protection as repellent on fruit trees and grapevine. EFSA supporting publication 2017:EN-1277. 21 pp.

         (4)  http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN.

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

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

         ANNEX I

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Specific provisions

                     Talc E553B
                     CAS No: 14807-96-6

                     Magnesium hydrogen metasilicate
                     silicate mineral

                     Food grade in conformity with Commission Regulation (EU) No 231/2012 (2).
                     < 0,1 % of respirable Crystalline Silica

                     28 May 2018

                     Talc E553B shall be used in accordance with the specific conditions included in the conclusions of the review report on Talc E553B (SANTE/11639/2017) and in particular Appendices I and II thereof.

            (1)  Further details on identity, specification and manner of use of the basic substance are provided in the review report.

            (2)  Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).

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

                        ‘19

                        Talc E553B
                        CAS No: 14807-96-6

                        Magnesium hydrogen metasilicate
                        silicate mineral

                        Food grade in conformity with Commission Regulation (EU) No 231/2012 (*1).
                        < 0,1 % of respirable Crystalline Silica

                        28 May 2018

                        Talc E553B shall be used in accordance with the specific conditions included in the conclusions of the review report on Talc E553B (SANTE/11639/2017) and in particular Appendices I and II thereof.

            (*1)  Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).’


title: Commission Implementing Regulation (EU) 2018/1043 of 24 July 2018 concerning the non-renewal of approval of the active substance fenamidone, 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:
                  25.7.2018

                  EN

                  Official Journal of the European Union

                  L 188/9

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1043
         of 24 July 2018
         concerning the non-renewal of approval of the active substance fenamidone, 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 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 2003/68/EC (2) included fenamidone 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 fenamidone, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2019.

                     (4)

                     An application for the renewal of the approval of fenamidone 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 12 February 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 11 February 2016 the Authority communicated to the Commission its conclusion (6) on whether fenamidone can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

                     (9)

                     The Autority identified specific concerns. In particular, it was not possible to conclude on the genotoxic potential of fenamidone and no health-based reference values could be set. Consequently, the consumer and non-dietary risk asessements could not be conducted. Furthermore, a high potential for groundwater contamination above the parametric drinking water limit of 0,1 μg/L by a toxicologically relevant metabolite (RPA 412708) was indicated in all pertinent scenarios for crops grown in soils of predominantly pH 7 or above. In addition, the Authority concluded that the consumer risk assessment for exposure to another groundwater metabolite (RPA 412636) which is also found in food of plant and animal origin could not be finalised. Furthermore, the residue definitions for risk assessment in plant and livestock commodities are not finalised in terms of the inclusion of potentially relevant metabolites. Finally, the Authority concluded that the risk assessment for wild mammals could not be finalised and a high risk to aquatic organisms from exposure to the metabolite acetophenone could not be excluded based on the available information.

                     (10)

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

                     (11)

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

                     (12)

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

                     (13)

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

                     (14)

                     Member States should be provided with time to withdraw authorisations for plant protection products containing fenamidone.

                     (15)

                     For plant protection products containing fenamidone, 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 14 November 2019.

                     (16)

                     Commission Implementing Regulation (EU) 2018/917 (7) extended the expiry date of fenamidone to 31 July 2019 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision is taken ahead of that extended expiry date, this Regulation should apply as soon as possible.

                     (17)

                     This Regulation does not prevent the submission of a further application for the approval of fenamidone 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 fenamidone 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 62, on fenamidone, is deleted.

            Article 3
            Transitional measures
            Member States shall withdraw authorisations for plant protection products containing fenamidone as active substance by 14 February 2019 at the latest.

            Article 4
            Grace period
            Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire by 14 November 2019 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, 24 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 (European Food Safety Authority), 2016. Conclusion on the peer review of the pesticide risk assessment of the active substance fenamidone. EFSA Journal 2016;14(2):4406, 173 pp. doi:10.2903/j.efsa.2016.4406. Available online: www.efsa.europa.eu

            (7)  Commission Implementing Regulation (EU) 2018/917 of 27 June 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, carvone, chlorpropham, cyazofamid, desmedipham, dimethoate, dimethomorph, diquat, ethephon, ethoprophos, etoxazole, famoxadone, fenamidone, fenamiphos, flumioxazine, fluoxastrobin, folpet, foramsulfuron, formetanate, Gliocladium catenulatum strain: J1446, isoxaflutole, metalaxyl-m, methiocarb, methoxyfenozide, metribuzin, milbemectin, oxasulfuron, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, pymetrozine and s-metolachlor (OJ L 163, 28.6.2018, p. 13).