21.6.2014 Official Journal of the European Union L 182/49 DIRECTIVES COMMISSION DIRECTIVE 2014/79/EU of 20 June 2014 amending Appendix C of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards TCEP, TCPP and TDCP (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (1), and in particular Article 46(2) thereof, Whereas: (1)  The substance tris(2-chloroethyl) phosphate (TCEP), CAS No 115-96-8, is a phosphate ester used as a flame-retar- dant plasticiser in polymers. The main industrial branches in which TCEP has been used are the building industry, the furniture and the textile industry. TCEP is classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (?) as carcinogenic category 2 and toxic for reproduction category 1B. (2)  Directive 2009/48/EC establishes general requirements for substances which are classified as carcinogenic, muta- genic or toxic for reproduction (CMR) under Regulation (EC) No 1272/2008. Such substances may not be used in toys, in components of toys or in micro-structurally distinct parts of toys, except if inaccessible to children, permitted by a Commission decision or contained in individual concentrations equal to or smaller than the rele- vant concentrations established for the classification of mixtures containing them as CMRs. In the absence of any specific requirements, TCEP can thus be contained in toys in concentrations equal to or smaller than the relevant concentration established for the classification of mixtures containing it as CMRs, namely 0,5 % as from 20 July 2013 and 0,3 % as from 1 June 2015 respectively. (3)  TCEP was comprehensively evaluated in 2009 under Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances (). The risk assessment report, entitled ‘European Union Risk assessment on TCEP’, shows that TCEP easily migrates, and, when ingested, results in toxicity in the kidney, liver and brain, causing health damages and potentially cancer. (4)  The risk assessment report also shows that since 2001 there is no EU TCEP production. Its use in the EU had also declined, TCEP being replaced progressively by other flame retardants. Nevertheless, the presence of TCEP in toys cannot be excluded, as most toys available on the EU market are imported, thus manufactured outside the EU. (5)  To assess the health effects of TCEP in toys and the appropriateness of Directive 2009/48/EC’s generic limits for TCEP as a CMR substance, the Commission sent a request for an opinion to the Scientific Committee on Health and Environmental Risks (SCHER). In its opinion, adopted on 22 March 2012 and entitled ‘Opinion on tris (2-chloroethyl) phosphate (TCEP) in toys’, SCHER notes that health effects (in particular kidney effects) have been observed after repeated exposure to 12 mg of TCEP/kg body weight per day. SCHER also notes that the TCEP content found by the Danish Environmental Protection Agency (Danish EPA) in toys (0,5-0,6 %), as reported in the Danish EPA’s ‘Survey and risk assessment of perfume and flavours in toys and childcare articles. Survey of chemical substances in consumer products’, corresponds to a risk for children, even without considering other exposures. When considering TCEP exposure from other sources than toys (e.g. air, dust), SCHER concludes that () OJL170,30.6.2009, p. 1. () OJL353,31.12.2008, p. 1. () OJL84,5.4.1993,p.1.