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 ci rculation of mercury in society by cutting 
supply and demand, the reduction of mercur y emissions and the protection against 
mercury emissions.  
(2) The strategy was reviewed in 2010 in the Communication from the Commission to the 
European  Parliament and the Council on the re view of the community strategy 
concerning mercury3, in which the Commission acknowledged that work will continue 
on the extension of the existing marketing re strictions for certain measuring devices 
containing mercury to additional devices used in the health care sector, in particular 
sphygmomanometers and for other pr ofessional and industrial uses. 
                                                 
1 OJ L 396, 30.12.2006, p 1. 
2 COM(2005)20 final. 
3 COM(2010) 723 final.   
EN 3   EN (3) 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. 
(4) 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 
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. It can change in the environment into methylmercury, its most toxic form. Methylmercury biomagnifies especia lly in the aquatic food chain, making the 
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, 
inhibiting potential mental development ev en before birth, making the exposure of 
women of child-bearing age and children of greatest concern. Mercury and its 
degradation products, mainly methylmercury, pr esent an equivalent level of concern to 
persistent, bioaccumulative and toxic substa nces (PBTs) and have long range transport 
properties. 
(5) Mercury measuring devices are used widesp read across Europe, l eading to a possible 
release of mercury to the environment dur ing all the stages of their lifecycle and 
contributing to the overall emissions of merc ury, and thereby also to the exposure of 
species and humans via the environment. 
(6) Regulation (EC) No 1907/2006,  in entry 18a of  Annex XVII, provides for a ban to the 
placing on the market of fever thermomete rs containing mercur y, as well as other 
mercury containing measuring devices intended for sale to the general public and  requests the Commission to carr y out a review of the availability of reliable safer 
alternatives that ar e technically and economically f easible for mercury containing 
sphygmomanometers and other measuring devices in healthcare and in other 
professional and industrial uses. On the ba sis of that review or as soon as new 
information on reliable safer alterna tives for sphygmomanometers and other 
measuring devices containing mercury woul d become available, the Commission is 
requested, if appropriate, to present a legi slative proposal to ex tend the restrictions 
already provided in that entry to sphygm omanometers and other measuring devices in 
healthcare and in other profe ssional and industrial uses, so that mercury in measuring 
devices is phased out whenever t echnically and economically feasible. 
(7) Based on the significant amount of new in formation collected, the Commission sent 
the European Chemicals Agency (hereinaft er 'the Agency') its review report and 
requested the Agency to prepare a dossier  conforming to the requirements of Annex 
XV to Regulation (EC) No 1907/2006 in accordance with Article 69 of that Regulation. 
                                                
 
4 Council conclusions of 15 March 2011 "Review of the Community Strategy concerning Mercury", of 4 
December 2008 "Addressing global mercury challenge s" and of 24 June 2005 "On the Community 
Strategy Concerning Mercury".  
EN 4   EN (8) The Agency has prepared a dossier proposi ng to restrict mercury in the following 
measuring devices used in industrial a nd professional (inclu ding healthcare) 
applications: mercury containing ba rometers, hygrometers, manometers, 
sphygmomanometers, strain gauges used  with plethysmographs, tensiometers, 
thermometers and other non-electrical thermo metric applications, mercury metering 
devices for the determination of softening point and mercury pycnometers. The dossier 
demonstrates that action on a Union-wide ba sis is necessary to address the risk to 
human health and environment posed by th e use of mercury in these measuring 
devices.  
(9) Alternative measuring devices without me rcury have become available and show 
significantly lower associated risks than th e health and environmental risks posed by 
mercury measuring devices. 
(10) Exceptions should be made in specific uses for sphygmomanometers, thermometers 
and mercury triple point cells, where technically feasible alternatives are not yet available.  
(11) A derogation should be granted to allow the general selling and buying of old, 
historically valuable mercury measuring devi ces which can be regarded as antiques or 
cultural goods. Regulation (EC) No 1907/2006, in entry 18a of Annex XVII, allows 
the placing on the market of mercury contai ning measuring devices intended for sale 
to the general public, other than fever thermo meters, if they were more than 50 years 
old on 3 October 2007. For reasons of clarity, the same age determinants should apply 
for the exception concerning the old meas uring devices used in industrial and 
professional (including h ealthcare) applications. 
(12) A derogation should also be granted for meas uring devices displayed in exhibitions for 
cultural and historical purposes, including those that were not 50 years old on 3 
October 2007 but have nevertheless  historical and cultural value. 
(13) On 8 June 2011, the Committee for Risk As sessment of the Agency adopted its 
opinion on the proposed restriction, which it considered as the most appropriate 
Union-wide measure to address the identified  risks in terms of the effectiveness in 
reducing the risks. 
(14) On 15 September 2011 the Committee for So cio-economic Analysis of the Agency 
adopted its opinion on the proposed restriction, which it considered as the most 
appropriate Union-wide measure to addre ss the identified risks in terms of the 
proportionality of its socio-economic be nefits to its socio-economic costs. 
(15) The Agency has submitted to the Commission the opinions of the Committees for Risk 
Assessment and Socio-economic Analysis. 
(16) Regulation (EC) No 1907/2006 should therefore be amended accordingly. 
(17) 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. 
(18) 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,  
EN 5   EN 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 [18 months  after entry into force].  
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels,  
 For the Commission 
 The President     
EN 6   EN ANNEX  
Annex XVII to Regulation (EC) No 1907/2006 is amended as follows: 
Entry 18a is amended as follows: (1)  paragraph 4 is deleted; (2) the following paragraphs 5 to 8 are added: 
 
  "5. The following mercury-containi ng measuring devices intended 
for industrial and professional uses  shall not be placed on the 
market after [18 months after entry into force]: 
(a) barometers;  (b) hygrometers;  (c) manometers;  (d) sphygmomanometers;  (e) strain gauges to be used with plethysmographs;  (f) tensiometers;  (g) thermometers and other non-electrical thermometric 
applications. 
The restriction shall also apply to measuring devices under points 
(a) to (g) which are placed on the market empty if intended to be 
filled with mercury. 
6. The restriction in paragraph 5 shall not apply to: (a) sphygmomanometers to be used:  
(i) in epidemiological st udies which are on-going 
on [date of entry into force]   
(ii) as reference standards in clinical validation 
studies of mercury-free sphygmomanometers; 
(b) thermometers exclusively inte nded to perform tests according 
to standards that require the use of mercury thermometers until [5 
years after  entr y into force]; 
(c) mercury triple point cells whic h are used for the calibration of 
platinum resistance thermometers. 
7. The following mercury-using m easuring devices intended for 
professional and industrial uses sh all not be placed on the market 
after [18 months after entry into force]: 
(a) mercury pycnometers;  (b) mercury metering devices for determination of the softening 
point. 
8. The restrictions in paragra phs 5 and 7 shall not apply to:  
EN 7   EN (a) measuring devices more than 50 years old on 3 October 2007; 
(b) measuring devices which are to be displayed in public 
exhibitions for cultural and historical purposes."