EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2014) XXX  draft 
  
COMMISSION DIRECTIVE ../…/EU 
of XXX  
amending Appendix A of Annex II to Directiv e 2009/48/EC of the European Parliament 
and of the Council on the safety  of toys, as regards nickel 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION DIRECTIVE ../…/EU 
of XXX  
amending Appendix A of Anne x II to Directive 2009/48/EC of  the European Parliament 
and of the Council on the safety of toys, as regards nickel 
(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 Eu ropean Parliament and of the Council of 18 
June 2009 on the safety of toys
1, and in particular Article 46(3) thereof, 
Whereas: (1) Directive 2009/48/EC establis hes general requirements for substances which are 
classified as carcinogenic, mutageni c or toxic for reproduction (CMR) under 
Regulation (EC) No 1272/2008 of the European Parliament and of the Council
2. CMR 
substances category 2 may not be used in to ys, in components of toys or in micro-
structurally distinct parts of toys, except if those substances  are contained in individual 
concentrations equal to or smaller than the relevant concentrations  established for the 
classification of mixtures containing them  as CMRs, they are inaccessible to children 
or their use has been permitted. The Commission may permit the use of CMR 
substances category 2 in toys if the use of the substance has been evaluated by the 
Scientific Committee and found to be safe, in particular in view of exposure, and the 
substance is not prohibited for use in c onsumer articles under Regulation (EC) No 
1907/2006 of the European Parl iament and of the Council3. Appendix A of Annex II 
to Directive 2009/48/EC contains the list of  CMR substances and their permitted uses. 
(2) Nickel (CAS No 7440-02-0) is  a typical metal. Its main primary uses are in the 
production of nickel-containing al loys (including stainless st eel), in nickel plating, in 
the production of nickel-containing products su ch as batteries and welding electrodes, 
and in the production of chemicals containing nick el. Nickel is also used in toys for its 
resistance to corrosion and its high elec trical conductivity, for example in model 
railway tracks and for battery contacts. 
(3) Nickel is classified under  Regulation (EC) No 1272/2008 as  carcinogenic category 2. 
In the absence of any specific requirements,  nickel can be contained in toys in 
                                                 
1 OJ L 170, 30.6.2009, p. 1. 
2 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 (OJ L 353, 31.12.2008, p. 
1). 
3 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18  December 2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), 
establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 
2000/21/EC (OJ L 396, 30.12.2006, p. 1).  
EN 3   EN concentrations equal to or smaller than the relevant concentration established for the 
classification of mixtures cont aining it as CMRs, namely 1 %. 
(4) Nickel was comprehensively evaluated under Council Regulation (EEC) No 793/934. 
The 2008 European Union Risk Assessment Report (EU RAR)5 concluded that, with 
regard to the occupa tional assessment regard ing carcinogenicity, th ere was a need for 
further studies to evaluate  the inhalation carcinogeni city of nickel. The 2009 
Addendum6 to the EU RAR, prepared for the purpose of the transitional measures 
under Regulation (EC) No 1907/2006, concluded that no further measures at Union 
level were required, as the results from the two-year carci nogenicity study with 
inhalation exposure of rats to  metallic nickel did not poi nt towards a revision of the 
existing carcinogenic ity classification. 
(5) Appendix A of Annex II to Directive 2009/48/EC  already permits the use of nickel in 
stainless steel in toys, as nickel in stainless steel has proven to be safe. 
(6) To assess the risk to health from the pr esence of metallic nickel in electric toys 
(plating, coating and alloys enabling el ectrical conductivity), the Commission asked 
the Scientific Committee on Health and Envi ronmental Risks (SCHER) for an opinion. 
SCHER notes in its opinion “Assessment of th e Health Risks from the Use of Metallic 
Nickel (CAS No 7440-02-0) in Toys”, a dopted on 25 September 2012, that a tumour 
risk due to nickel exposure  when handling toys is not present since inhalation of 
metallic nickel from toys is extremely unlikely. SCHER further concludes that the use of nickel in parts of toys allowing the correct electric f unction of toys will result in a 
very low potential for exposure to nickel by oral and dermal intake, due to the 
restrictions on nickel release applicable to metal-containi ng parts in toys, the limited 
accessibility of the metal-containing parts a nd the small surface area of the nickel-
containing parts allowing the correct function of electric to ys. Thus, health risks are 
not expected by SCHER. 
(7) In accordance with point 5(c)(ii) of Part III of Annex II to Directive 2009/48/EC, the 
use of CMR substances category 2 cannot be  permitted if the substance is prohibited 
for use in consumer articles under Regulation (EC) No 1907/2006. Entry 27 of Annex XVII to that Regulation only restricts the us e of nickel in post assemblies which are 
inserted into pierced ears and other pi erced parts of the human body, in articles 
intended to come into direct and prolonged  contact with the skin and in articles 
intended to come into direct and prolonged contact with the skin where those have a 
non-nickel coating. The restric tions of entry 27 of Annex XVII to Re gulation (EC) No 
1907/2006 do not amount to a fu ll ban for use in all cons umer articles under that 
Regulation. This Directive should not affect the application of en try 27 of Annex XVII 
to Regulation (EC) No 1907/2006 to toys whic h are articles intended to come into 
direct and prolonged contact with the skin. 
(8) Directive 2009/48/EC should therefore be amended accordingly. 
(9) The measures provided for in this Regula tion are in accordance with the opinion of 
the Committee established in Ar ticle 47 of Directive 2009/48/EC, 
                                                
 
4 Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of 
existing substances, OJ L 84, 5.4.1993, p. 1. 
5 http://echa.europa.eu/documents/10162/cefda8bc-2952-4c11-885f-342aacf769b3   
6 http://echa.europa.eu/documents/10162/13630/nickel_denmark_en.pdf    
EN 4   EN HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Appendix A of Annex II to Directive 2009/48/EC is replaced by the following: 
"Appendix A 
List of CMR substances and their permitted uses in accordance with points 4, 5 and 6 of Part 
III 
Substance Classification Permitted use 
Nickel CMR 2 In stainless steel and in parts of toys allowing 
the correct electric function of toys 
" 
Article 2 
1. Member States shall adopt and publish, by [… The date falling 12 months after the 
publication date ] at the latest, the laws, regula tions 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 [… The same date as in the previous 
subparagraph ]. 
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 determin e 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 3 
This Directive shall enter into force on the tw entieth day following that of its publication in 
the Official Journal of  the European Union . 
Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 The President  José Manuel Barroso