EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2014) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annex XVII to Regulation (EC) No  1907/2006 of the European Parliament 
and of the Council on the Registration, E valuation, Authorisation and Restriction of 
Chemicals ("REACH") as regards lead and its compounds 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annex XVII to Regulation (EC)  No 1907/2006 of the European Parliament 
and of the Council on the Registration, Eval uation, Authorisation and Restriction of 
Chemicals ("REACH") as regar ds lead and its compounds 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the 
Council of 18 December 2006 concerning the Regi stration, Evaluation, Authorisation and 
Restriction of Chemicals (REA CH), 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
1, and in particular Article 
68(1) thereof, 
Whereas: (1) On 21 December 2012, Sweden submitted to the European Chemicals Agency 
(hereinafter ‘the Agency’) a dossier pursuan t to Article 69(4) of Regulation (EC) No 
1907/2006 (hereinafter ‘the Annex XV dossie r’), demonstrating that due to their 
mouthing behaviour, children, especially those under 36 m onths, may be repeatedly 
exposed to lead released fr om consumer articles contai ning lead or lead compounds. 
Lead and lead compounds are present in consumer articles as intentionally added 
metallic lead, as an impurity or additive of metal alloys (particularly in brass), as pigments, and as a stabiliser in po lymers (particularly in PVC).   
(2) Repeated exposure to lead fr om mouthing of articles cont aining lead or its compounds 
can result in severe and irreversible ne urobehavioural and neur odevelopmental effects 
to which children are particularly sensitive given that their central nervous system is 
still under development. The placing on the market and us e of lead and its compounds 
in articles that are supplied to the general public, and which can be placed in the mouth 
by children, should therefore be prohibited if  the concentration of  lead (expressed as 
metal) in that article, or part of th e article, exceeds a certain threshold.  
(3) On 10 December 2013, the Committee for Ri sk Assessment (hereinafter ‘RAC’) 
adopted its opinion, concluding that the restri ction is the most appropriate Union-wide 
measure to address the identified risks pos ed by lead and its compounds present in 
articles intended for consumer use in terms of the effectiveness in reducing such risks 
and proposing certain modifications of  the scope of the restriction.   
(4) On 13 March 2014, the Committee for Socio-Ec onomic Analysis (hereinafter 'SEAC') 
adopted its opinion in which it concluded th at the restriction proposed by the dossier 
submitter, as modified by RAC and also by SEAC, was the most appropriate Union-
                                                
 
1 OJ L 396, 30.12.2006, p. 1.  
EN 3   EN wide measure to address the identified risks,  in particular in terms of proportionality. 
This conclusion was reached after analysis of available socio-economic evidence and 
on the basis of best available estimates for unc ertainty factors, taking into account that 
there is no threshold for the neurobehaviour al and neurodevelopmen tal effects of lead. 
(5) The Agency’s Forum for Exchange of Information on Enforcement was consulted 
during the restrictions proce ss and its opinion was taken in to account contributing to a 
modified description of the scope and ex emptions from the proposed restriction. 
(6) It has to be concluded that an unacceptabl e risk to human health arises from the 
presence of lead and its compounds in arti cles supplied to the general public exceeding 
the content limits or, alternatively, the migr ation rate limit as specified in the opinions. 
Those risks need to be addre ssed on a Union-wide basis..  
(7) On the basis of the established derived mi nimal effect level of lead, the mouthing 
behaviour of children and studi es on lead migration from me tallic parts of jewellery, a 
limit content for lead should be set which will apply to metallic and non-metallic parts of articles unless it can be s hown that the rate of lead re lease does not exceed a certain 
threshold. For coated articles, th e coating should be sufficient to  ensure that this rate is 
not exceeded for a period of at least two years of normal use of the article.   
(8) Exemptions from this Regulation should be ma de for certain articles in relation to 
which the expected migration level is low, su ch as crystal glass, enamels and precious 
and semi-precious stones, or acceptable provided that a certain content limit is not exceeded, which may be the case for brass al loys, and for specified articles whose 
small size means that exposure to lead is mi nimal, namely tips of writing instruments.  
(9) Keys, locks, padlocks and mu sical instruments can potenti ally be mouthed by children 
and therefore may pose a risk to children if they contain lead. However, those articles 
should be exceptionally exempted as there seems to be a lack of suitable alternatives to 
lead in the manufacture of  those articles, and the po ssible adverse socio-economic 
impact of applying the restriction to them could be significant. 
(10) Articles already covered by specific Union legislation regulating lead content or 
migration should, for reasons of consistency, be exempted.  
(11) Economic operators should be allowed a transitional period to adapt their 
manufacturing to the restrict ion laid down by this Regulation and to dispose of their 
stock not yet placed on the market. Furtherm ore, the restriction should not apply to 
second hand articles which were placed on th e market for the first time before the end 
of that transitional period as that would give rise to considerable enforcement 
difficulties. 
(12) Regulation (EC) No 1907/2006 should th erefore be amended accordingly.  
(13) The measures provided for in this Regulati on are in accordance with the opinion of the 
Committee established under Article 133 of Regulation (EC) No 1907/2006, 
 HAS ADOPTED THIS REGULATION: 
Article 1 
Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to 
this Regulation.   
EN 4   EN Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union .  
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President