24.11.2015 Official Journal of the European Union L 306/23 COMMISSION DIRECTIVE (EU) 2015/2117 of 23 November 2015 amending, for the purpose of adopting specific limit values for chemicals used in toys, Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards chloromethylisothiazolinone and methylisothiazolinone, both individually and in a ratio of 3:1 (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 ('), and in particular Article 46(2) thereof, Whereas: (1)  In order to ensure a high level of protection of children against risks caused by chemical substances in toys, Directive 2009/48/EC establishes certain requirements with regard to chemical substances such as those classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (%, allergenic fragrances and certain elements. In addition, Directive 2009/48/EC empowers the Commission to adopt specific limit values for chemicals used in toys which are intended for children under 36 months and in other toys intended to be placed in the mouth in order to ensure adequate protection in the case of toys involving a high degree of exposure. The adoption of such limit values takes the form of an inclusion in Appendix C to Annex II to Directive 2009/48/EC. (2)  For a number of chemicals, currently applicable limit values are either too high in the light of available scientific evidence or do not exist. Specific limit values should therefore be adopted for them, taking into account the packaging requirements for food as well as the differences between toys and food contact materials. (3)  In order to advise the European Commission in the preparation of legislative proposals and policy initiatives in the area of toy safety, the Commission established the Expert Group on Toys Safety. The mission of its subgroup ‘Chemicals’ is to provide such advice with regard to chemical substances which may be used in toys. (4) 5-Chloro-2-methylisothiazolin-3(2H)-one (CMI) and 2-methylisothiazolin-3(2H)-one (MI) in a ratio of 3:1 (CAS number 55965-84-9) (}) as well as its individual components CMI (CAS number 26172-55-4) and MI (CAS number 2682-20-4) are used as preservatives in water-based toys (*) including hobby paints, finger paints, window/glass paints, glues and soap bubbles (°). (5)  In its deliberations about CMI and MI in a ratio of 3:1 as well as the individual components CMI and MI the subgroup ‘Chemicals’ took as a basis the related opinion of the Scientific Committee on Health and Environ- mental Risks (SCHER) noting that neither CMI and MI in a ratio of 3:1 nor the individual components CMI or MI are recommended for use in toys, due to contact allergic reactions observed with these substances in () OJL170,30.6.2009, p. 1. (*) 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 67/548EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). (®) Trade names are Kathon, Acticide, Microcare, etc., according to the Scientific Committee on Consumer Safety (SCCS), Opinion on the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one. Opinion adopted on 8 December 2009, p. 6. (*) Danish EPA (2014) Survey and health assessment of preservatives in toys. Survey of chemical substances in consumer products No 124, 2014, table 24 on p. 56. (°) Danish EPA (2014) Survey and health assessment of preservatives in toys. Survey of chemical substances in consumer products No 124, 2014, pp. 38-39.