EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX 
[…](2011) XXX draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX 
amending Annex XVII to Regulation (EC) No 1907/2006 of the Eu ropean Parliament 
and of the Council on the Registration, E valuation, Authorisation and Restriction of 
Chemicals ("REACH") as regards lead 
(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 regards lead 
(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) In accordance with Regulation (EC) No  1907/2006, if a Member State considers 
that the manufacture, placing on the market or use of a substance on its own, in a 
mixture or in an article poses  a risk to human health or the environment that is not 
adequately controlled and n eeds to be addressed, it sha ll prepare a dossier after 
notifying that intention to the European Chemicals Agency (hereinafter "the Agency").  
(2) On 15 April 2010 France submitted to the Agency a dossier pursuant to Article 
69(4) of Regulation (EC) No 1907/2006, in order to initiate a restrictions process in 
accordance with Articles 69 to 73 of that  Regulation. In that dossier it is 
demonstrated that repeated exposure to lead contained in je wellery and imitation 
jewellery articles (hereinafter referred to as 'jewellery articles') may occur, which 
can result in severe and irreversible neurobehavioural and neuro-developmental 
effects. Children, by mouthing such articles, are particularly  sensitive to this hazard 
given that their central nervous system is still under development and that no threshold for neurotoxic effects have been identified in humans for lead. The dossier 
demonstrates that action on a Union-wide  basis is necessary , beyond any measures 
already in place, in order to avoid as much  as possible the exposure to lead and its 
compounds in jewellery articles. Accordi ngly, the dossier proposes a prohibition of 
                                                
 
1 OJ L 396, 30.12.2006, p. 1.  
EN 3   EN the use of lead and its com pounds in jewellery articles a nd the placing on the market 
of such articles if the lead migr ation is greater th an 0,09 µg/cm²/hr. 
(3) The Agency has submitted to the Commission the opinions of the Committee for 
Risk Assessment (hereinafter "RAC")  and the Committee for Socio-economic 
Analysis (hereinafter "SEAC"). 
(4) In its opinion of 10 March 2011, RAC consid ers that the most appropriate Union-
wide measure to address the identified risks in terms of the effectiveness in reducing 
the risks is prohibiting the use of l ead and its compounds in metallic and non-
metallic parts of jewellery articles and prohibiting the placing on the market of such articles or parts thereof, if the lead con centration is equal to or greater than 0,05% 
by weight of the part, and unle ss it can be demonstrated that the rate of lead release 
from the jewellery article or any part thereof does not exceed 0,05 µg/cm²/hr (0,05 
µg/g per hour). 
(5) In its opinion of 15 September 2011, SEAC considers that prohi biting the use of 
lead and its compounds in jewellery articles  and hair accessories  and the placing on 
the market of such articles, if the lead concentration is equal to or greater than 
0,05% by weight of any individu al part thereof, is the mo st appropriate Union-wide 
measure to address the identified risks in terms of the proportionality of its socio-
economic benefits to its socio-economic cost s. In view of the non-availability at 
present of a migration test method mimicking mouthing conditions, SEAC 
considers that the restric tion should be based on the content of lead in any 
individual parts of jeweller y articles and hair accessori es, and not on the migration 
rate of lead released from such articles . In addition, SEAC recommends exemptions 
to be provided for crystal glass, vitreous  enamels, internal components of watch 
timepieces as well as non-synthetic or r econstructed precious  and semiprecious 
stones. The Commission agrees wi th the assessment made by SEAC. 
(6) Crystal glass and vitreous enamels should be exempted from the restriction given 
the scientific uncertainties related to the migration rates of lead from these materials and the lack of suitable alternatives thereto.  
(7) For the same reasons applicable to crystal glass and vitreous enamels, non-synthetic 
or reconstructed precious and semiprecious stones in which lead is present as a 
naturally occurring constituent should be exempted.  
(8) Internal components of watch timepieces  which are inaccessible to consumers 
should be exempted from the restriction, as  exposure to lead from those components 
can be excluded.  
(9) Not allowing the placing on the market of old jewellery which does not comply with 
the lead concentration limit would have a significant socio-economic impact, as 
such old items would lose their market able value in the Union, and would pose 
insurmontable difficulties for enforcement.  Therefore, jewellery articles placed on 
the market up to 12 months after the entry into force of the restriction as well as 
imported antique jewellery articles shoul d be exempted from the restriction. 
(10) 
Given the uncertainties related to the migration rates of lead from crystal and 
vitreous enamels as well as the developments taking place in these sectors such as  
EN 4   EN the development of alternatives or migra tion test methods, the restriction should be 
reviewed in the future in the li ght of new scientific information. 
(11) The measures provided for in this Regulat ion 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.  
Article […] 
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  […] 
  
EN 5   EN ANNEX  
In Annex XVII to Regulation (EC) No 1907/ 2006, the following entry 63 is added:  
"63. Lead 
 CAS No 7439-92-1 
 EC No 231-100-4 
      and its compounds 1. Shall not be used or placed on the 
market if the concentration of lead is equal to or greater than 0,05 % by weight of any individual part of jewellery and imitation jewellery articles and hair accessories, including:  (a) bracelets, necklaces and rings;  (b) piercing jewellery;  (c) wrist watches and wrist-wear;  (d) brooches and cufflinks.  2. For the purposes of paragraph 1 "Any individual part" shall include the materials from which the jewellery is made, as well as the individual components. Paragraph 1 shall 
also apply to individual parts when used or 
placed on the market for jewellery-making. 
3. By way of derogation, paragraph 1 shall 
not apply to: 
 (a) crystal glass as defined in Annex I 
(categories 1, 2, 3 and 4) to Council Directive 69/493/EEC(*); 
 (b) internal components of watch 
timepieces inaccessible to consumers; 
 (c) non synthetic or reconstructed 
precious and semiprecious stones (CN code 7103, as established by Regulation (EEC) No 2658/87), unless they have been treated with lead or its com pounds or mixtures 
containing these substances; 
 (d) enamels, defined as vitrifiable 
products resulting from the fusion, vitrification or sint ering of minerals 
melted at a temperature of at least 500 °C. 
4. By way of derogation, paragraph 1 shall 
not apply to jewellery articles placed on the 
market before [insert date - 12 months after the date of entry into force of this Regulation] and jewell ery articles produced  
EN 6   EN before 10 December 1961. 
5. By [insert date - 5 years after the date of 
entry into force of this Regulation], the Commission shall re-evaluate this entry in the light of new scientific information, including the availability of alternatives and the migration of lead and its compounds from the articles referred to in paragraph 1 and, if appropriate, modify this entry accordingly. 
(*) OJ L 326, 29.12.1969, p. 36."