26.3.2014 Official Journal of the European Union L 90/1 II (Non-legislative acts) REGULATIONS COMMISSION REGULATION (EU) No 301/2014 of 25 March 2014 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards chromium VI compounds (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, the Union have already developed and widely imple- mented measures in order to control and minimise its formation. ) ) (3) On 28 November 2012 the Committee for Risk Having regarq to Regulation (EC) No .1907/ 2006 of the Assessment (hereinafter ‘RAC) adopted by consensus European Parliament and of the Council of 18 December the opinion on the restriction proposed in the Annex 2006 concerning the Registration, Evaluation, Authorisation XV dossier. According to the RAC opinion, the and Restriction of Chemicals (REACH), .estabhshlng a restriction is the most appropriate Union-wide measure European Chemmals Agency, amendlng Directive 1999/45[EC to address the identified risks posed by chromium VI and repealing Council Regulation (EEC) No 793/93 and compounds in leather, both in terms of effectiveness Commission Regulation (EC) No 1488/94, as well as Council and practicability. However, in its opinion RAC Directive 76/769/EEC and Commission Directives 91/155/EEC, proposed to modify the restriction by deleting the 93/67[EEC, 93/105/EC and 2000/21/EC ('), and in particular notion of direct and prolonged contact with the skin, Article 68(1) thereof, originally included in the Annex XV dossier. Whereas: () The proposed restriction focuses on the risk of induction 0 On 19y W12 the Knglom of Demak o) din snion el o dt o it i submitted to the European Chemicals Agency (hereinafter o hromi read parts q | ‘Agency’) a dossier pursuant to Article 69(4) of Regu- con}tlammg ¢ r0m1unll VI‘I.I? anrea ly sensitise pTop & lation (EC) No 1907/2006, in order to initiate the such contacts mgy asho elict Ze(irgéc reipo?scel at 0“’6? restrictions process in accordance with Articles 69 to concentrations than those needed for the induction o 73 of that Regulation (hereinafter ‘Annex XV dossier). sensitisation. In that dossier, it was demonstrated that exposure to chromium VI, when contained in leather articles or leather parts of articles coming into contact with the (55 The proposed restriction should cover leather articles and skin, poses a r1§k to human health. C}-lr.om.mm VI articles containing leather parts used by consumers or compounds can induce new cases of sensitisation and workers, that under normal or reasonably foreseeable elicit allergic response. The dossier demonstrates that conditions of use come into contact with the skin. action on a Union-wide basis is necessary. (20 Chromium VI compounds can be formed in leather (6)  The EN ISO 17075 standard method is the only inter- through the oxidation of chromium III compounds, which are added in some tanning processes to cross- link the collagen subunits in order to increase leather’s dimensional stability, as well as its resistance to mech- anical action and heat. According to the Annex XV dossier, the mechanisms of and conditions under which chromium VI is formed are known and most tanneries in () O] L 396, 30.12.2006, p. 1. nationally ~ recognised analytical method currently available to detect chromium VI in leather, including leather in articles. The determination limit of the EN ISO 17075 standard method is 3 mg/kg (0,0003 % by weight) of chromium VI content in the total dry weight of the leather. Fixing such threshold for the restriction of the placing on the market of leather articles or articles containing leather parts is therefore justified for monitor- ability and enforceability purposes.