Commercial Information Circulars

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Ref : EIC 230/2/12

30 June 2014

Dear Sirs,

Commercial Information Circular No. 624/2014

European Union (EU)* : Amendment to Directive on the Safety of Toys

Further to Commercial Information Circular No. 603/2014 dated 25 June 2014, the European Commission (the Commission) has adopted a Directive to amend Appendix C of Annex II of Directive 2009/48/EC on the safety of toys regarding bisphenol A. Details are set out in the Commission Directive 2014/81/EU, which can be accessed through the following link:
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:JOL_2014_183_R_0009&from=EN

DETAILS

2.Directive 2009/48/EC establishes general requirements for substances which are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures. European standard EN 71-9:2005+A1:2007 then provides a migration limit of 0.1 mg/l for bisphenol A. Bisphenol A is classified under Regulation (EC) No. 1272/2008 as toxic for reproduction category 2. In the absence of any specific requirements, bisphenol A can 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 5% as from 20 July 2013 and 3% as from 1 June 2015 respectively. However, it cannot be excluded that that concentration may lead to increased exposure of small children to bisphenol A, compared with the migration limit of 0.1mg/l for bisphenol set by European Standard EN 71-9:2005+A1:2007, EN 71-10:2005 and EN 71-11:2005. Although the final risk assessment report concluded that further research was needed to resolve the uncertainties surrounding the potential for bisphenol A to produce adverse effects on development at low doses, a high level of protection of children against risks caused by chemical substances in toys warrants incorporating the migration limit of 0.1 mg/l for bisphenol A into Directive 2009/48/EC.

3.Specific limit values for bisphenol A used in toys intended by children under 36 months or in other toys intended to be placed in the mouth is set out in Article 1 of the Directive 2014/81/EU. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by 21 December 2015 at the latest.

ENQUIRIES

4.For enquiries concerning the content of this circular, please contact the undersigned at telephone number 2398 5556.

Yours faithfully,

(Miss Anita WONG)
for Director-General of Trade and Industry

* The EU includes Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.