Commercial Information Circulars

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e-mail address : enquiry@tid.gov.hk

Ref : EIC 230/2/12

4 December 2015

Dear Sirs,

Commercial Information Circular No. 1151/2015

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

Further to Commercial Information Circular No. 647/2014 dated 9 July 2014, the European Commission (the Commission) has adopted three Directives to amend Appendix C of Annex II of Directive 2009/48/EC on the safety of toys concerning formamide, benzisothiazolinone as well as chloromethylisothiazolinone and methylisothiazolinone both individually and in a ratio of 3:1.  Details are set out in the Commission Directives (EU) 2015/2115, 2015/2116 and 2015/2117, which can be accessed through the following links:
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32015L2115&from=EN
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32015L2116&from=EN
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32015R0648&from=EN

DETAILS

2.Directive 2009/48/EC establishes certain requirements with regard to chemical substances such as those classified as carcinogenic, mutagenic or toxic for reproduction under Regulation (EC) No. 1272/2008, allergenic fragrances and certain elements. It also 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. The adoption of such limit values is included in Appendix C of Annex II of Directive 2009/48/EC.

3.Formamide is used in the plastics and polymers industry, particularly as a solvent, plasticiser or as a substance associated with a blowing agent used in the production of foam. According to the Expert Group on Toys Safety, it is recommended that the emissions of formamide from foam toy materials should be limited to 20μg /m³ after a maximum of 28 days from commencement of the emission testing and the emission testing is not necessary when the formamide content is 200 mg/kg or less. Therefore, Commission Directive (EU) 2015/2115 is adopted to amend Appendix C of Annex II of Directive 2009/48/EC as regards formamide.

4.1,2-Benzisothiazol-3(2H)-one (1,2-benzisothiazolin-3-one, BIT) is used as a preservative in water-based toys including hobby paints and finger paints. According to the Expert Group on Toys Safety, it is recommended that BIT in toys should be limited to its limit of quantification (LOQ), namely to a maximum concentration of 5 mg/kg and the use of BIT is not regulated for food contact materials. Therefore, Commission Directive (EU) 2015/2116 is adopted to amend Appendix C of Annex II of Directive 2009/48/EC as regards benzisothiazolinone.

5.5-Chloro-2methylisothiazolin-3(2H)-one (CMI) and 2-methylisothiazolin-3(2H)-one (MI) in a ratio of 3:1 as well as its individual components CMI and MI are used as preservatives in water-based toys including hobby paints, finger paints, window/glass paints, glues and soap bubbles. According to the Expert Group on Toys Safety, it is recommended that CMI and MI in a ratio of 3:1 should not be used in toys and to limit the uses of CMI and MI individually to their LOQs. Therefore, Commission Directive (EU) 2015/2117 is adopted to amend Appendix C of Annex II of Directive 2009/48/EC as regards chloromethylisothiazolinone and methylisothiazolinone, both individually and in a ratio of 3:1.

6.The 3 Directives shall enter into force on 14 December 2015. Member States shall adopt and publish, by 24 November 2017 at the latest, the laws, regulations and administrative provisions necessary to comply with these Directives.

ENQUIRIES

7.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 member countries are 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.