HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 101/12
EN
Official Journal of the European Union
15.4.2011
II
(Non-legislative acts)
REGULATIONS
COMMISSION REGULATION (EU) No 366/2011
of 14 April 2011
amending 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 Annex
XVII (Acrylamide)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(3) Commission
Recommendation
2004/394/EC
of
29
April
2004 on the results of the risk evaluation and the risk
reduction strategies for the substances: Acetonitrile;
Having regard to the Treaty on the Functioning of the European
Acrylamide; Acrylonitrile; Acrylic acid; Butadiene;
Union,
Hydrogen fluoride; Hydrogen peroxide; Methacrylic acid;
Methyl methacrylate; Toluene; Trichlorobenzene
( 3 ),
adopted within the framework of Regulation (EEC) No
Having regard to Regulation (EC) No 1907/2006 of the
793/93, recommended consideration at Union level of
European Parliament and of the Council of 18 December
marketing and use restrictions in Council Directive
2006 concerning the Registration, Evaluation, Authorisation
76/769/EEC of 27 July 1976 on the approximation of
and Restriction of Chemicals (REACH), establishing a
the laws, regulations and administrative provisions of the
European Chemicals Agency, amending Directive 1999/45/EC
Member States relating to restrictions on the marketing
and repealing Council Regulation (EEC) No 793/93 and
and use of certain dangerous substances and prep
Commission Regulation (EC) No 1488/94 as well as Council
arations ( 4 ), for the use of acrylamide in grouts for
Directive 76/769/EEC and Commission Directives 91/155/EEC,
small and large-scale applications.
93/67/EEC, 93/105/EC and 2000/21/EC ( 1 ), and in particular
Article 131 thereof,
(4)
The limit value of 0,1 % of acrylamide is included to
cover other sources of free acrylamide in the grouting
Whereas:
process such as from N-methylolacrylamide, as indicated
in Recommendation 2004/394/EC.
(1) Acrylamide
is
classified
as
a
carcinogenic
category
1B
and
mutagenic category 1B substance. Its risks were evaluated
in accordance with Council Regulation (EEC) No 793/93
(5) In
order
to
protect
human
health
and
the
environment,
it
of 23 March 1993 on the evaluation and control of the
is therefore necessary to restrict the placing on the
risks of existing substances ( 2 ).
market and the use of acrylamide in grouts and for all
grouting applications.
(2) The
results
of
the
European
risk
assessment
concluded
that there was a need to limit the risk to the aquatic
compartment from use of acrylamide based grouts in
(6) In
accordance
with
the
provisions
on
transitional
construction applications, and risk to other organisms
measures in Article 137(1)a of REACH, it is necessary
from indirect exposure through contaminated water
to amend Annex XVII to Regulation (EC) No 1907/2006.
from the same application. Furthermore, concerns for
workers and humans exposed via the environment
were raised in view of the carcinogenic and mutagenic
nature of acrylamide and for its neurotoxicity and repro
(7) The
measures
provided
for
in
this
Regulation
are
in
ductive toxicity as a consequence of exposure arising
accordance with the opinion of the Committee estab
from small and large-scale use of acrylamide based
lished under Article 133 of Regulation (EC) No
grouts.
1907/2006,
( 1 ) OJ L 396, 30.12.2006, p. 1.
( 3 ) OJ L 144, 30.4.2004, p. 72.
( 2 ) OJ L 84, 5.4.1993, p. 1.
( 4 ) OJ L 262, 27.9.1976, p. 201.

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EN
15.4.2011 Official
Journal
of
the
European
Union L
101/13
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 20th day following 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, 14 April 2011.
For the Commission
The President
José Manuel BARROSO
ANNEX
In the table of Annex XVII to Regulation (EC) No 1907/2006, the following entry 60 is added:
‘60. Acrylamide
Shall not be placed on the market or used as a substance or constituent of mixtures in a
concentration, equal to or greater than 0,1 % by weight for grouting applications after
CAS No 79-06-1
5 November 2012.’

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