Official Journal L 43 of the European Union Volume 63 English edition Legislation 17 February 2020 Contents II Non-legislative acts REGULATIONS ★ Commission Implementing Regulation (EU) 2020/202 of 4 October 2019 granting a Union authorisation for the biocidal product family ‘Iodine Teat Dip Products’ (1) . 1 ★ Commission Delegated Regulation (EU) 2020/203 of 28 November 2019 on classification of vehicles, obligations of European Electronic Toll Service users, requirements for interoperability constituents and minimum eligibility criteria for notified bodies (2) . 41 ★ Commission Implementing Regulation (EU) 2020/204 of 28 November 2019 on detailed obligations of European Electronic Toll Service providers, minimum content of the European Electronic Toll Service domain statement, electronic interfaces, requirements for interoperability constituents and repealing Decision 2009/750/EC . 49 ★ Commission Regulation (EU) 2020/205 of 14 February 2020 amending Regulation (EC) No 2073/2005 as regards Salmonella in reptile meat (3) . 63 ★ Commission Implementing Regulation (EU) 2020/206 of 14 February 2020 authorising the placing on the market of fruit pulp, pulp juice, concentrated pulp juice from Theobroma cacao L. as a traditional food from a third country under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Implementing Regulation (EU) 2017/2470 (4) . 66 ★ Commission Implementing Regulation (EU) 2020/207 of 14 February 2020 amending Regulation (EU) No 142/2011 as regards imports of petfood from Saudi Arabia (5) . 69 ★ Commission Implementing Regulation (EU) 2020/208 of 14 February 2020 amending Regulation (EC) No 29/2009 laying down requirements on data link services for the single European sky (6) . 72 (6) Text with EEA relevance. Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period. EN The titles of all other acts are printed in bold type and preceded by an asterisk. DECISIONS ★ Commission Implementing Decision (EU) 2020/209 of 14 February 2020 concerning certain protective measures relating to African swine fever in Greece (notified under document C(2020) 962) (7) . 74 ★ Commission Implementing Decision (EU) 2020/210 of 14 February 2020 amending the Annex to Implementing Decision (EU) 2020/47 on protective measures in relation to highly pathogenic avian influenza of subtype H5N8 in certain Member States (notified under document C(2020) 963) (8) . 77 (8) Text with EEA relevance. 17.2.2020 EN Offi cial Jour nal of the European Uni on L 43/1 II (Non-legislative acts) REGULATIONS COMMISSION IMPLEMENTING REGULATION (EU) 2020/202 of 4 October 2019 granting a Union authorisation for the biocidal product family ‘Iodine Teat Dip Products’ (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 Article 44(5) thereof, Whereas: (1) On 20 August 2015, GEA Farm Technologies GmbH, submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Iodine Teat Dip Products’ (‘the biocidal product family’) of product-type 3, as described in Annex V to that Regulation. The competent authority of United Kingdom agreed to evaluate the application as referred to in Article 43(1) of Regulation (EU) No 528/2012. The application was recorded under the case number BC-AL019223-55 in the Register for Biocidal Products. (2) The biocidal product family contains iodine, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012. Taking into account the intrinsic properties of the active substance, and the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100 (2), the Commission will consider the need to review the approval of iodine, including polyvinylpyrrolidone iodine, in accordance with Article 15 of Regulation (EU) No 528/2012. Depending on the outcome of that review, the Commission will then consider whether the Union authorisations for products containing the active substance have to be reviewed in accordance with Article 48 of Regulation (EU) No 528/2012. (3) On 6 June 2018, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’). (4) On 18 January 2019, the Agency submitted to the Commission an opinion (3), including the draft summary of the biocidal product characteristics (‘SPC’) of the biocidal product family and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concludes that the biocidal product family falls within the definition of ‘biocidal product family’ laid down in Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, the biocidal product family meets the conditions laid down in Article 19(1) and (6) of that Regulation. (1) OJ L 167, 27.6.2012, p. 1. (2) Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1). (3) ECHA opinion of 14 December 2018 on the Union authorisation of ‘Iodine Teat Dip Products’ (ECHA/BPC/217/2018). L 43/2 EN Offi cial Jour nal of the European Union 17.2.2020 (5) On 20 May 2019, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. (6) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family. (7) 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 A Union authorisation is granted to GEA Farm Technologies GmbH for the making available on the market and use of the biocidal product family ‘Iodine Teat Dip Products’ with authorisation number EU-0020125-0000 in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 19 November 2019 until 31 October 2029. 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, 4 October 2019. For the Commission The President Jean-Claude JUNCKER 17.2.2020 EN Offi cial Jour nal of the European Uni on L 43/3 ANNEX Summary of product characteristics for a biocidal product family Iodine Teat dip products Product type 3 — Veterinary hygiene (Disinfectants) Authorisation number: EU-0020125-0000 R4BP asset number: EU-0020125-0000 PART I FIRST INFORMATION LEVEL 1. ADMINISTRATIVE INFORMATION 1.1. Family name Name Iodine Teat dip products 1.2. Product type(s) Product type(s) PT03 — Veterinary hygiene (Disinfectants) 1.3. Authorisation holder Name and address of the authorisation Name GEA Farm Technologies GmbH holder Address Siemensstraße 25-27, 59199, Bönen, Germany Authorisation number EU-0020125-0000 R4BP asset number EU-0020125-0000 Date of the authorisation 19 November 2019 Expiry date of the authorisation 31 October 2029 1.4. Manufacturer(s) of the biocidal products Name of manufacturer GEA Farm Technologies Address of manufacturer Wylye Works, BA12 9HT Warminster United Kingdom Location of manufacturing sites Wylye Works, Watery Lane, BA12 9HT Warminster United Kingdom Gewerbestraße 5, 5325 Plainfeld Austria ul. Olowiana 10, 85-461 Bydgoszcz Poland 1.5. Manufacturer(s) of the active substance(s) Active substance Iodine Name of manufacturer SQM Europe N.V. Address of manufacturer St Pietersvliet 7„ bus 8 2000 Antwerp Belgium Location of manufacturing sites Sociedad Quimica y Minera SA, Los Militares, Las Condes, 4290 Piso 4 Santiago Chile L 43/4 EN Offi cial Jour nal of the European Union 17.2.2020 Active substance Iodine Name of manufacturer Nihon Tennen Gas Co., Ltd (Via Mitsui & Co Europe PLC) Address of manufacturer Chiba Plant, 2508 Minami-Hinata, Shirako-Machi, Chosei-Gun„ 299-4205 Chosei-Gun Japan Location of manufacturing sites Chiba Plant, 2508 Minami-Hinata, Shirako-Machi, Chosei-Gun„ 299-4205 Chosei-Gun Japan Active substance Iodine Name of manufacturer Norkem Ltd Address of manufacturer Norkem House, Bexton Lane„ WA16 9FB Knutsford United Kingdom Location of manufacturing sites OFICINA CALA CALA S/N, Unknown POZO ALMONTE Chile 2. PRODUCT FAMILY COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the family Content (%) Common name IUPAC name Function CAS number EC number Min Max Iodine Active Substance 7553-56-2 231-442-4 0,16 2,47 C9-11 Alcohol C 9-11 alcohol Non-active sub­ 68439-46-3 614-482-0 0,0 2,35 Ethoxylate with 6 moles of stance ethoxylate. Var­ ious brand names available including Im­ bentin C- 91-060 2.2. Type(s) of formulation Formulation(s) AL — Any other liquid SL — Soluble concentrate PART II SECOND INFORMATION LEVEL — META SPC(S) META SPC 1 1. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier Identifier Meta SPC 1 — Concentrates — Professional concentrates with 1:3, 1:4 and 1:7 dilution rates 17.2.2020 EN Offi cial Jour nal of the European Uni on L 43/5 1.2.
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