EN    EN EN  
EN    EN  EUROPEAN COMMISSION 
Brussels, xxx 
C(20..) yyy final 
  
DRAFT – 1 June 2010 
 
Draft 
COMMISSION REGULATION (EU) No …/.. 
of […] 
amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council 
on the Registration, Evaluation, Authorisat ion and Restriction of Chemicals (REACH) 
as regards Annex XVII (Acrylamide)  
EN 2   EN Draft 
COMMISSION REGULATION (EU) No …/.. 
of […] 
amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council 
on the Registration, Evaluation, Authorisat ion and Restriction of Chemicals (REACH) 
as regards Annex XVII (Acrylamide) 
(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 
131 thereof, 
Whereas: 
(1) Acrylamide is classified as a carcinogeni c category 1B and mutagenic category 1B 
substance. Its risks were evaluated in acco rdance with Council Regulation (EEC) No 
793/93 of 23 March 1993 on the evaluation a nd control of the risks of existing 
substances2. 
(2) The results of the European risk assessment concluded that there was a need to limit 
the risk to the aquatic compartment for use of acrylamide based grouts in construction 
applications, and risk to ot her organisms from indirect exposure through contaminated 
water from the same application. Furthe rmore, concerns for workers and humans 
exposed via environment were raised in  view of the carcinogenic and mutagenic 
nature of acrylamide and for its neurot oxicity and reproductive toxicity as a 
consequence of exposure arising from sma ll and large-scale use of acrylamide based 
grouts. 
(3) Commission Recommendation 2004/394/EC of 29  April 2004 on the results of the risk 
evaluation and the risk re duction strategies for the substances: Acetonitrile; 
Acrylamide; Acrylonitrile; Acrylic acid; Butadiene; Hydrogen fluoride; Hydrogen 
                                                 
1 OJ L 396, 30.12.2006, p. 1. 
2 OJ L 84, 5.4.1993, p.1  
EN 3   EN peroxide; Methacrylic acid; Methyl me thacrylate; Toluene;  Trichlorobenzene3, 
adopted within the framework of Re gulation (EEC) No 793/93, recommended to 
consider at Union level marketing and use restrictions in Council Directive 
76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member St ates relating to restrictions on the 
marketing and use of certain dange rous substances and preparations
4, for the use of 
acrylamide in grouts for small a nd large-scale ap plications.  
(4) The limit value of 0.1% of acrylamide is included to cover other source of free 
acrylamide in the grouting process such as fr om N-methylolacrylamide, as indicated in 
Recommendation 2004/394/EC. 
(5) In order to protect human h ealth and the environment, it is therefore necessary to 
restrict the placing on the market and the use of acrylamide in grouts and for all 
grouting applications. 
(6) In accordance with the provisions on transi tional measures in Article 137(1)a of 
REACH, it is necessary to amend Anne x XVII to Regulati on (EC) No 1907/2006. 
(7) 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 . 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, […] 
  For the Commission 
 The President  […] 
  
                                                
 
3 OJ L 144, 30.4.2004, p.72 
4 OJ L 262, 27.9.1976, p.201.  
EN 4   EN ANNEX  
In the table of Annex XVII to Regulati on (EC) No 1907/2006, the following entry 60 is 
added:  
 
“60. Acrylamide 
CAS No 79-06-1 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 appli cations after [18 months after the 
entry into force of this Regulation].”