# Commission Directive 2014/81/EUShow full title

Commission Directive 2014/81/EU of 23 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 bisphenol A (Text with EEA relevance)         

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U.K.

# Commission Directive 2014/81/EU                     

# of 23 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 bisphenol A                     

# (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)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 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(2). 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 relevant concentrations established for the classification of mixtures containing them as CMRs. To further protect                              children's health, specific limit values for such substances can be set out, when appropriate, for toys intended for use by                              children under three years old or other toys intended to be placed in the mouth.

(2)The substance bisphenol A is a high volume chemical that is widely used in the production of a large variety of consumer products.                              Bisphenol A is used as a monomer in the manufacture of polycarbonate plastics. Polycarbonate plastics are used, amongst others,                              in the manufacture of toys. Moreover, bisphenol A has been found in certain toys.

(3)Council Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the Member States concerning the safety of                              toys(3) governed the essential safety requirements for chemical properties of toys until 19 July 2013. European standard EN 71-9:2005+A1:2007                              provides a migration limit of 0,1 mg/l for bisphenol A. European standards EN 71-10:2005 and EN 71-11:2005 provide the relevant                              test methods. The limits and methods for bisphenol A set out in EN 71-9:2005+A1:2007, EN 71-10:2005 and EN 71-11:2005 are                              used by the toy industry as a reference to ensure that there is no unsafe exposure from bisphenol A in toys. Yet, those standards                              do not constitute harmonised standards.

(4)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.                              It cannot be excluded that that concentration may lead to increased exposure of small children to bisphenol A, compared to                              the migration limit of 0,1 mg/l for bisphenol A set by European standards EN 71-9:2005+A1:2007, EN 71-10:2005 and EN 71-11:2005.

(5)Bisphenol A was comprehensively evaluated in 2003 and 2008 under Council Regulation (EEC) No 793/93 of 23 March 1993 on the                              evaluation and control of the risks of existing substances(4). The final risk assessment report, entitled ‘Updated European Union Risk Assessment Report 4,4'-isopropylidenediphenol (bisphenol-A)’,                              found, among other things, that bisphenol A has endocrine modulating activity in a number of *in vitro* and *in vivo* screening assays and 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. Nevertheless, a high level of protection of children against                              risks caused by chemical substances in toys, in the light of the particular needs of children, who are a vulnerable group                              of consumers, warrants incorporating the migration limit of 0,1 mg/l for bisphenol A into Directive 2009/48/EC.

(6)The effects of bisphenol A are under evaluation in scientific fora including the European Food Safety Authority. The migration                              limit laid down by this Directive should be reviewed if relevant new scientific information becomes available in the future.

(7)Directive 2009/48/EC should therefore be amended accordingly.

(8)The measures provided for in this Directive are in accordance with the opinion of the Toy Safety Committee,

HAS ADOPTED THIS DIRECTIVE:

# Article 1U.K.

Appendix C of Annex II to Directive 2009/48/EC is replaced by the following:

## “Appendix CSpecific 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 adopted in accordance with Article 46(2)

# Article 2U.K.

1.Member States shall adopt and publish, by 21 December 2015 at the latest, the laws, regulations and administrative provisions                        necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.                  

They shall apply those provisions from 21 December 2015.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference                     on the occasion of their official publication. Member States shall determine how such reference is to be made.                  

2.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the                        field covered by this Directive.                  

# Article 3U.K.

This Directive shall enter into force on the twentieth day following that of its publication in the *Official Journal of the European Union*.                  

# Article 4U.K.

This Directive is addressed to the Member States.

Done at Brussels, 23 June 2014.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

1

OJ L 170, 30.6.2009, p. 1.                           

2

OJ L 353, 31.12.2008, p. 1.                           

3

OJ L 187, 16.7.1988, p. 1.                           

4

OJ L 84, 5.4.1993, p. 1.