Official Journal L 203 of the European Union ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ Volume 60 English edition Legislation 4 August 2017 Contents II Non-legislative acts REGULATIONS ★ Commission Regulation (EU) 2017/1413 of 3 August 2017 amending Annex IV to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (1) 1 ★ Commission Implementing Regulation (EU) 2017/1414 of 3 August 2017 amending Annex I to Regulation (EC) No 798/2008 as regards the entries for the former Yugoslav Republic of Macedonia, the United States, South Africa and Zimbabwe in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into or transit through the Union in relation to highly pathogenic avian influenza (1) .............. 4 DECISIONS ★ Commission Implementing Decision (EU) 2017/1415 of 3 August 2017 amending the Annex to Implementing Decision (EU) 2017/247 on protective measures in relation to outbreaks of the highly pathogenic avian influenza in certain Member States (notified under document C(2017) 5571) (1) .............................................................................................................. 9 ★ Commission Implementing Decision (EU) 2017/1416 of 3 August 2017 concerning certain protective measures relating to African swine fever in Romania (notified under document C(2017) 5570) (1) .............................................................................................................. 19 (1) 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. EN 4.8.2017 EN Official Journal of the European Union L 203/1 II (Non-legislative acts) REGULATIONS COMMISSION REGULATION (EU) 2017/1413 of 3 August 2017 amending Annex IV to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (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 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (1), and in particular Article 31(1) thereof, Whereas: (1) Zinc oxide is authorised as a colorant in cosmetic products under entry 144 of Annex IV to Regulation (EC) No 1223/2009. (2) In its opinion of 18 September 2012 (2), which was revised in 23 September 2014 (3), the Scientific Committee on Consumer Safety (SCCS) concluded that the use of zinc oxide is safe when used as colorant, in its uncoated non-nano form, in cosmetics for dermal application. However, the SCCS also considered that in view of the lung inflammation induced by zinc oxide particles after inhalation, the use of zinc oxide in cosmetic products that may result in exposure of the consumer's lungs to zinc oxide by inhalation was of concern. (3) In light of the SCCS opinions, the use of zinc oxide as a colorant, in its uncoated non-nano form, in cosmetic products should be restricted to those applications which may not lead to exposure of the end-user's lungs by inhalation. (4) Annex IV to Regulation (EC) No 1223/2009 should therefore be amended accordingly. (5) The industry should be allowed a reasonable period of time to make the necessary adjustments to product formulations in view of their placing on the market and for the withdrawal of non-compliant products from the market. (6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products, HAS ADOPTED THIS REGULATION: Article 1 Annex IV to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation. (1) OJ L 342, 22.12.2009, p. 59. (2) SCCS/1489/12 Revision of 11 December 2012, http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_103.pdf (3) SCCS/1539/14 Revision of 25 June 2015, http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_163.pdf L 203/2 EN Official Journal of the European Union 4.8.2017 Article 2 From 24 February 2018 only cosmetic products which comply with this Regulation shall be placed on the Union market. From 24 May 2018 only cosmetic products which comply with this Regulation shall be made available on the Union market. Article 3 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 3 August 2017. For the Commission The President Jean-Claude JUNCKER 4.8.2017 ANNEX Entry 144 of Annex IV to Regulation (EC) No 1223/2009 is replaced by the following: Substance identification Conditions Wording of con­ EN Reference Colour index Product Maximum concentra­ ditions of use and number Number/Name of CAS Chemical Name EC number Colour type, Body tion in ready for use Other warnings Common Ingredients number parts preparation Glossary a b c d e f g h i j ‘144 Zinc oxide (*) 77947 1314-13-2 215-222-5 White Not to be used in applications that may lead to exposure of the end- user's lungs by inhalation. Official (*) For use as a UV-filter, see Annex VI, No 30 and No 30a.’. Jour nal of the European Union L 203/3 L 203/4 EN Official Journal of the European Union 4.8.2017 COMMISSION IMPLEMENTING REGULATION (EU) 2017/1414 of 3 August 2017 amending Annex I to Regulation (EC) No 798/2008 as regards the entries for the former Yugoslav Republic of Macedonia, the United States, South Africa and Zimbabwe in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into or transit through the Union in relation to highly pathogenic avian influenza (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (1), and in particular the introductory phrase of Article 8, the first subparagraph of point 1 of Article 8, point 4 of Article 8 and Article 9(4)(c) thereof, Having regard to Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra- Community trade in, and imports from third countries of, poultry and hatching eggs (2), and in particular Articles 23(1), 24(2) and 25(2) thereof, Whereas: (1) Commission Regulation (EC) No 798/2008 (3) lays down veterinary certification requirements for imports into and transit, including storage during transit, through the Union of poultry and poultry products (the commodities). It provides that the commodities are only to be imported into and transit through the Union from the third countries, territories, zones or compartments listed in columns 1 and 3 of the table in Part 1 of Annex I thereto. (2) Regulation (EC) No 798/2008 also lays down the conditions for a third country, territory, zone or compartment to be considered as free from highly pathogenic avian influenza (HPAI). (3) The former Yugoslav Republic of Macedonia is listed in Part 1 of Annex I to Regulation (EC) No 798/2008 as a third country from which imports into and transit through the Union of certain poultry commodities are authorised from the whole of its territory. (4) On 28 January 2017, the former Yugoslav Republic of Macedonia confirmed the presence of HPAI of subtype H5N8 in a poultry holding on its territory. Due to that confirmed outbreak of HPAI, the territory of the former Yugoslav Republic of Macedonia could no longer be considered as free from that disease and the veterinary authorities of the former Yugoslav Republic of Macedonia were no longer in a position to certify consignments of meat of poultry for human consumption for import into, or transit through, the Union. It is appropriate therefore to indicate in Part 1 of Annex I to Regulation (EC) No 798/2008, the date as of which that third country could no longer be considered as free from HPAI. (5) Following the outbreak of HPAI in January 2017, the former Yugoslav Republic of Macedonia has implemented a stamping-out policy in order to control and limit the spread of that disease. The former Yugoslav Republic of Macedonia has submitted updated information on the epidemiological situation on its territory and the measures it has taken to prevent the further spread of HPAI which has now been evaluated by the Commission. In addition, the former Yugoslav Republic of Macedonia has reported the completion of cleaning and disinfection measures following the stamping out policy on the poultry holding where the HPAI outbreak was detected in January 2017. (6) On the basis of the evaluation of the information provided by the former Yugoslav Republic of Macedonia, it is also appropriate to indicate in Part 1 of Annex I to Regulation (EC) No 798/2008 the date as of when that third country may again, in accordance with Article 9 of Regulation (EC) No 798/2008, be considered free of HPAI and imports into, and transit through the Union, of certain poultry commodities originating from that third country should be authorised again. (1) OJ L 18, 23.1.2003, p. 11. (2) OJ L 343, 22.12.2009, p. 74. (3) Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (OJ L 226, 23.8.2008, p.