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20.9.2012 Official
Journal
of
the
European
Union L
253/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION REGULATION (EU) No 847/2012
of 19 September 2012
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the
Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as
regards mercury
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
of the existing marketing restrictions for certain
measuring devices containing mercury to additional
devices used in the healthcare sector, in particular sphyg
momanometers and for other professional and industrial
Having regard to the Treaty on the Functioning of the European
uses.
Union,
Having regard to Regulation (EC) No 1907/2006 of the
(3) The
Council
has
reaffirmed
several
times
its
commitment
European Parliament and of the Council of 18 December
to the overall objective of protecting human health and
2006 concerning the Registration, Evaluation, Authorisation
the environment from the release of mercury and its
and Restriction of Chemicals (REACH), establishing a
compounds by minimising and, where feasible, ultimately
European Chemicals Agency, amending Directive 1999/45/EC
eliminating global anthropogenic mercury releases to air,
and repealing Council Regulation (EEC) No 793/93 and
water and land. In this context, the Council underlined
Commission Regulation (EC) No 1488/94 as well as Council
that mercury-added products, where viable alternatives
Directive 76/769/EEC and Commission Directives 91/155/EEC,
exist, should be phased out as rapidly and as completely
93/67/EEC, 93/105/EC and 2000/21/EC ( 1 ), and in particular
as possible, with the ultimate goal that all mercury-added
Article 68(1) thereof,
products should be phased-out, taking into due account
technical and economic circumstances and the needs for
scientific research and development ( 4 ).
Whereas:
(4) Mercury
and
its
compounds
are
highly
toxic
to
humans,
(1)
In its Communication to the Council and the European
ecosystems and wildlife. High doses can be fatal to
Parliament on a Community Strategy Concerning
humans, but even relatively low doses can have serious
Mercury ( 2 ) the Commission outlined that it is
adverse neurodevelopmental impacts and have also been
necessary to reduce mercury levels in the environment
linked with possible harmful effects on the cardiov
and human exposure and proposed as objectives, among
ascular, immune and reproductive systems. Mercury is
others, the reduction of entry into circulation of mercury
considered as a global persistent pollutant, circulating
in society by cutting supply and demand, the reduction
between air, water, sediments, soil and biota in various
of mercury emissions and the protection against mercury
forms. It can change in the environment into methyl
emissions.
mercury, its most toxic form. Methylmercury biom
agnifies especially in the aquatic food chain, making
the human population and wildlife with a high intake
of fish and seafood particularly vulnerable. Methyl
(2)
The strategy was reviewed in 2010 in the Communi
mercury readily passes both the placental barrier and
cation from the Commission to the European Parliament
the blood-brain barrier, inhibiting potential mental devel
and the Council on the review of the community strategy
opment even before birth, making the exposure of
concerning mercury
( 3 ), in which the Commission
women of child-bearing age and children of greatest
acknowledged that work will continue on the extension
( 4 ) Council conclusions of 15 March 2011 ‘Review of the Community
( 1 ) OJ L 396, 30.12.2006, p. 1.
Strategy concerning Mercury’, of 4 December 2008 ‘Addressing
( 2 ) COM(2005) 20 final.
global mercury challenges’ and of 24 June 2005 ‘On the
( 3 ) COM(2010) 723 final.
Community Strategy Concerning Mercury’.

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L 253/2
EN
Official Journal of the European Union
20.9.2012
concern. Mercury and its degradation products, mainly
(10) For ongoing epidemiological studies using mercury
methylmercury, present an equivalent level of concern
sphygmomanometers the method of measurement
to persistent, bioaccumulative and toxic substances
should not be changed, therefore a derogation should
(PBTs) and have long range transport properties.
be granted until these studies are completed. For sphyg
momanometers used as reference standard for validation
of mercury free devices it was not possible to establish
the time needed to develop and recognise as reference
(5) Mercury
measuring
devices
are
used
widely
across
standard mercury-free alternatives, therefore the dero
Europe, leading to a possible release of mercury to the
gation for these devices should be without time limit.
environment during all the stages of their lifecycle and
contributing to the overall emissions of mercury, and
thereby also to the exposure of human population and
other species via the environment.
(11) For
thermometers
exclusively
intended
to
perform
tests
according to standards that require the use of mercury
thermometers a time period is needed to amend those
(6) Regulation
(EC)
No
1907/2006,
in
entry
18a
of
Annex
standards, therefore derogation should be granted for a
XVII, provides for a ban on the placing on the market of
period of five years. Given that mercury is needed as a
fever thermometers containing mercury, as well as other
reference point in the 1990 International Temperature
mercury containing measuring devices intended for sale
Scale a derogation should also be granted, without time
to the general public, and requests the Commission to
limit, for mercury triple point cells which are used for
carry out a review of the availability of reliable safer
the calibration of platinum resistance thermometers.
alternatives that are technically and economically
feasible for mercury containing sphygmomanometers
and other measuring devices in healthcare and in other
professional and industrial uses. On the basis of that
(12) For porosimeters, mercury electrodes used in volt
review, or as soon as new information on reliable safer
ammetry and mercury probes used for capacitance
alternatives for sphygmomanometers and other
voltage determination, feasible alternatives are not yet
measuring devices containing mercury becomes available,
available, therefore no restriction is proposed for these
the Commission is requested, if appropriate, to present a
measuring devices.
legislative proposal to extend the restrictions already
provided in that entry to sphygmomanometers and
other measuring devices in healthcare and in other
professional and industrial uses, so that mercury in
(13) A
derogation
should
be
granted
to
allow
the
general
measuring devices is phased out whenever technically
selling and buying of old, historically valuable mercury
and economically feasible.
measuring devices 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 containing measuring devices intended for sale
(7) Based
on
the
significant
amount
of
new
information
to the general public, other than fever thermometers, if
collected, the Commission sent the European Chemicals
they were more than 50 years old on 3 October 2007.
Agency (hereinafter ‘the Agency’) its review report and
For reasons of clarity, the same age determinants should
requested the Agency to prepare a dossier conforming to
apply for the exception concerning the old measuring
the requirements of Annex XV to Regulation (EC) No
devices used in industrial and professional (including
1907/2006 in accordance with Article 69 of that Regu
healthcare) applications.
lation.
(8) The
Agency
has
prepared
a
dossier
proposing
to
restrict (14) A derogation should also be granted for measuring
mercury in the following measuring devices used in
devices displayed in exhibitions for cultural and historical
industrial and professional (including healthcare) appli
purposes, including those that were less than 50 years
cations: mercury containing barometers, hygrometers,
old on 3 October 2007 but have nevertheless historical
manometers, sphygmomanometers, strain gauges used
and cultural value.
with plethysmographs, tensiometers, thermometers and
other non-electrical thermometric applications, mercury
metering devices for the determination of softening point
and mercury pycnometers. The dossier demonstrates that
(15) On
8
June
2011,
the
Committee
for
Risk
Assessment
of
action on a Union-wide basis is necessary to address the
the Agency adopted its opinion on the proposed
risk to human health and environment posed by the use
restriction, which it considered as the most appropriate
of mercury in these measuring devices.
Union-wide measure to address the identified risks in
terms of the effectiveness in reducing the risks.
(9) Alternative
measuring
devices
without
mercury
have
become available and show significantly lower associated
(16) On
15 September 2011 the
Committee for Socioe
risks than the health and environmental risks posed by
conomic Analysis of the Agency adopted its opinion
mercury measuring devices.
on the proposed restriction, which it considered as the

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EN
20.9.2012 Official
Journal
of
the
European
Union L
253/3
most appropriate Union-wide measure to address the
(20) The
measures
provided
for
in
this
Regulation
are
in
identified risks in terms of the proportionality of its
accordance with the opinion of the Committee estab
socioeconomic benefits to its socioeconomic costs.
lished under Article 133 of Regulation (EC) No
1907/2006,
(17) The Agency has submitted to the Commission the
HAS ADOPTED THIS REGULATION:
opinions of the Committees for Risk Assessment and
Socioeconomic Analysis.
Article 1
Annex XVII to Regulation (EC) No 1907/2006 is amended in
(18) Regulation
(EC) No 1907/2006 should therefore be
accordance with the Annex to this Regulation.
amended accordingly.
Article 2
This Regulation shall enter into force on the twentieth day
(19) It
is
appropriate
to
provide
for
a
reasonable
period
of
following that of its publication in the Official Journal of the
time for the stakeholders concerned to take the measures
European Union.
that may be required to comply with the measures set
out in this Regulation.
It shall apply from 10 April 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 September 2012.
For the Commission
The President
José Manuel BARROSO

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L 253/4
EN
Official Journal of the European Union
20.9.2012
ANNEX
In Annex XVII to Regulation (EC) No 1907/2006, the entry 18a is amended as follows:
(1) paragraph 4 is deleted;
(2) the following paragraphs 5 to 8 are added:
‘5. The
following
mercury-containing
measuring
devices
intended
for
industrial
and
professional uses shall not be placed on the market after 10 April 2014:
(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 studies which are ongoing on 10 October 2012;
(ii) as reference standards in clinical validation studies of mercury-free sphygmom
anometers;
(b) thermometers exclusively intended to perform tests according to standards that
require the use of mercury thermometers until 10 October 2017;
(c) mercury triple point cells which are used for the calibration of platinum resistance
thermometers.
7. The
following
mercury-using
measuring
devices
intended
for
professional
and
industrial uses shall not be placed on the market after 10 April 2014:
(a) mercury pycnometers;
(b) mercury metering devices for determination of the softening point.
8. The
restrictions
in
paragraphs
5
and
7
shall
not
apply
to:
(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.’

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