(Under forberedelse) Kommisjonsdirektiv om endring av europaparlaments- og rådsdirektiv 2009/48/EF med hensyn til spesifikke grenseverdier for anilin i visse leketøy
(Draft) Commission Regulation amending Directive 2009/48/EC of the European Parliament and of the Council as regards specific limit values for aniline in certain toys
Utkast til forordning lagt fram av Kommisjonen 24.9.2020 med tilbakemeldingfrist 22.10.2020
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) Directive 2009/48/EC establishes certain requirements for chemical substances that are classified as carcinogenic, mutagenic or toxic for reproduction under Regulation (EC) No 1272/2008 of the European Parliament and of the Council. Appendix C to Annex II to Directive 2009/48/EC lays down specific limit values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth.
(2) Aniline (CAS number 62-53-3) is classified as carcinogenic category 2 and mutagenic category 2 under Regulation (EC) No 1272/2008. According to point 5(a) of Part III of Annex II to Directive 2009/48/EC, carcinogenic substances of category 2, such as aniline, may be used in toys in individual concentrations equal to or smaller than the relevant concentration established in Regulation (EC) No 1272/2008 for the classification of mixtures containing those substances, namely 1 %, which corresponds to 10 000 mg/kg ('content limit'). The same content limit applies to mutagenic substances of category 2.
(3) The Scientific Committee on Health and Environmental Risks (SCHER) considered, in its opinion of 29 May 2007, that compounds that are carcinogenic, mutagenic or toxic for reproduction (CMR) should not be present in toys. The European Union Risk Assessment Report on aniline concluded that for consumers there is a need for limiting the health risks associated with the use of products containing aniline. That conclusion is based on concerns with regard to mutagenic and carcinogenic effects for consumers as a consequence of exposure to aniline, since aniline is identified as a non-threshold carcinogen, as confirmed by the Committee for Risk Assessment of the European Chemicals Agency (RAC) who indicated, in its opinion on restriction of substances in tattoo inks and permanent make-up, that aniline is considered a non-threshold carcinogen. Aniline may therefore cause cancer at even the slightest level of exposure.
(4) In order to advise the Commission in the preparation of legislative proposals and policy initiatives in the area of toy safety, the Commission has established the Expert Group on Toys Safety. The mission of its subgroup Working group on Chemicals in Toys (subgroup Chemicals) is to provide advice to the Expert Group on Toys Safety with regard to chemical substances which may be used in toys.
(5) During the meeting of the subgroup Chemicals on 18 February 2015, several of its members indicated that aniline could be found in coloured toy material such as textiles or leather when that material is subjected to the reductive cleavage test provided for in Appendix 10 to Regulation 1907/2006 of the European Parliament and of the Council. The occurrence of aniline in textiles after reductive cleavage testing was confirmed in a study carried out in Sweden as a follow-up to the meeting of the Expert Group on Toys Safety on 8 June 2015. Out of 23 textile samples, aniline was identified in one red textile (4 % of all samples) at 91 mg/kg. The occurrence of aniline in clothing after reductive cleavage testing was confirmed in a study with 153 samples. Aniline was identified in 9 samples (6 % of all samples) at up to 588 mg/kg. Moreover, aniline has been found in a finger paint after reductive cleavage according to a German consumer magazine. The subgroup Chemicals also noted, by written correspondence to the Commission in May 2020, that free aniline could be present in finger paints as an impurity of the colourants in such paints.
(6) At the meeting of the Expert Group on Toys Safety on 8 June 2015, Germany presented a position paper providing a scientific assessment of the toxicological properties of aniline. According to that assessment, the existing content limit for
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