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 European Parliament 
and of the Council on the Registration, E valuation, Authorisation and Restriction of 
Chemicals ("REACH") 
 
(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") 
 
(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 its Communication to the Council and the European Parliament on a Community 
Strategy Concerning Mercury2 the Commission outlined that it is necessary to reduce 
mercury levels in the environment and human exposure and proposed as objectives, 
among others, the reduction of entry into circulation of mercury in society, by cutting supply and demand, the reduction of mercur y emissions and the protection against 
mercury emissions. That Communi cation was reviewed in 2010
3. 
(2) The Council has reaffirmed several times its  commitment to the overall objective of 
protecting human health and the environm ent from the release of mercury and its 
compounds by minimising and, where feas ible, ultimately eliminating global 
anthropogenic mercury releases to air, water and land4. 
(3) Mercury and its compounds are highly toxi c to humans, ecosystem  and wildlife. High 
doses can be fatal to humans, but even re latively low doses can have serious adverse 
                                                 
1 OJ L 396, 30.12.2006, p 1. 
2 COM (2005) 20 final. 
3 COM(2010) 723 final.  
4 Council Conclusions of 15 March 2011 "Review of the Community Strategy Concerning Mercury", of 
4 December 2008 "Addressing global mercury challe nges" and of 24 June 2005 "On th e Community 
Strategy Concerning Mercury".  
EN 3   EN neurodevelopmental impacts and have also been linked with possi ble harmful effects 
on the cardiovascular, immune and reproductive systems. Mercury is considered as a 
global persistent pollutant, circ ulating between air, water, sediments, soil and biota in 
various forms and can change in the environment into me thylmercury, its most toxic 
form.  
(4) Regulation (EC) No 1907/2006 pr ovides that, if a Member State considers that the 
manufacture, placing on the ma rket 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 needs to  be addressed, it shall prepar e a dossier after notifying that 
intention to the European Chemicals Agency (hereinafter 'the Agency'). 
(5) Pursuant to Decision of the EEA Jo int Committee No 25/2008 of 14 March 2008 
amending Annex II (Technical regulations, stan dards, testing and certification) to the 
EEA Agreement5, Regulation (EC) No 1907/2006 was incorporated into the 
Agreement on the European Economic Area.  
(6) Norway has prepared a dossier concerni ng five phenylmercury compounds, namely 
phenylmercury acetate, phenylmercury propion ate, phenylmercury 2-ethylhexanoate, 
phenylmercury octanoate and phenylmercury neodecanoate, which demonstrates that 
action on a Union-wide basis is necessary to address the risk to human health and the 
environment posed by the manufacture, us e and placing on the market of those 
substances, on their own, in mixtures and articles. That dossier was submitted to the Agency in order to initiate  the restricti on process.  
(7) The five phenylmercury compounds are known to be widely used  as catalysts in 
polyurethane systems used for coatings , adhesives, sealants and elastomer 
applications. The mercury catalysts are inco rporated into the polymer structure and 
remain in the final article from which mercury or phenylmercury compounds are not released intentionally.
  
(8) The life-cycle of th e phenylmercury compounds leads to  a significant release of 
mercury to the environment and adds to the overall emissions of mercury.  
(9) The phenylmercury compounds are degraded in  the environment and give degradation 
products, including methylmercury, with equiva lent level of conc ern to persistent, 
bioaccumulative and toxic substances (PBT s). The interconversion of phenylmercury 
compounds metabolites allows for long range transport properties.  Therefore as 
transformation/degradation products with PBT-propertie s are being generated, the 
phenylmercury compounds themselves must be treated like PBT-substances with regard to emission and exposure control. To this end, the exposures and emissions to humans and the environment should be minimized as much as possible. 
(10) The main exposure to humans via the environment may be through food, in which the 
phenylmercury compounds degradation produ cts, including methylmercury, may be 
found. Methylmercury biomagnifies especia lly in the aquatic food chain, making 
population and wildlife w ith a high intake of fish and seafood particularly vulnerable. 
Methylmercury readily passes both the placen tal barrier and the blood-brain barrier, 
                                                
 
5 OJ L 182, 10.7.2008, p. 11.  
EN 4   EN inhibiting potential mental development ev en before birth, making the exposure of 
women of child-bearing age and children of greatest concern.  
(11) On 10 June 2011, the Committee for Risk As sessment of the Agency adopted its 
opinion on the proposed restriction, taking in to account its effec tiveness in reducing 
the risks to human health and the environment. 
(12) On 15 September 2011 the Committee for So cio-Economic Analysis of the Agency 
adopted its opinion on the proposed restricti on, taking into account its effectiveness in 
addressing the identified risks in terms of  the proportionality of its socio-economic 
benefits to its socio-economic costs. 
(13) The Agency has submitted to the Commission the opinions of the Committees for Risk 
Assessment and Socio-Economic Analysis. 
(14) It is appropriate to provide for a reas onable period of time for the stakeholders 
concerned to take the measures that may be  required to comply with the measures set 
out in this Regulation. 
(15) 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.  
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 . 
It shall apply from [insert date - 5 years af ter entry into force of  this Regulation]  
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 62 is added:  
"62.  
(a) Phenylmercury acetate 
EC No.: 200-532-5 CAS No.: 62-38-4  (b) Phenylmercury propionate EC No.: 203-094-3 CAS No.: 103-27-5  (c) Phenylmercury 2-ethylhexanoate EC No.: 236-326-7 CAS No.: 13302-00-6  (d) Phenylmercury octanoate 
EC No.: - 
CAS No.: 13864-38-5  (e) Phenylmercury neodecanoate EC No.: 247-783-7 CAS No.: 26545-49-3 1. Shall not be manufactured, placed on the 
market or used as substances or in mixtures.  
Articles or any parts thereof containing one 
or more of these substances shall not be placed on the market. 
2. By way of derogation, the restriction in 
paragraph 1 is not applic able to mixtures and 
articles, if the concentration of mercury in the mixture or in the article or any part 
thereof is smaller or equal to 0,01% weight by weight."