EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2015) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and V to Regulation (EC) No 1223/2009 of the European 
Parliament and of the Council on cosmetic products   EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending  Annexes II and V to Regulation (EC) No 1223/2009 of the European 
Parliament and of the Council on cosmetic products  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1223/200 9 of the European Parliament and of the 
Council of 30 November 2009 on cosmetic products1, and in particular Article 31 (1) thereof,  
Whereas:  
(1) The substance 2 -Chloroacetamide, with the INCI name Chloroacetamide, is authorized 
as a preservative in entry 41 o f Annex V to Regulation (EC) No  1223/2009 at a use 
concentration of up to 0,3 % w/w in ready for use preparation.  
(2) Chloroacetamide has been classified as a substance toxic for reproduction of 
category  3 under Directive 67/548/EEC2 (based on the criteria of Regulation (EC) No 
1272/2008, toxic for reproduction of category 2). The classification of Directive 
67/548/EEC was applicable before 1 December  2010 , after which Article 15 (1) of 
Regulation (EC) No 1223/2009 started to apply . Consequently, the automatic ban for 
substances classified as carcinogenic,  mutagenic or toxic for reproduction  (CMR) 
foreseen by Article 15 (1) of Regulation (EC) No 1223/2009,  does not apply . The use 
of this substance in cosmetic products has been assessed  by the Scientific Committee 
on Consumer Safety ( SCCS )3, which concluded in March 2011  that, on the basis of the 
available data, the subs tance is not safe for consumers  when used at the current 
concentration of up to  0,3 % w/w in cosmetic products.  
(3) Follow ing the scientific opinion of the SCCS, the Commission considers that the use 
of Chloroacetamide  in cosmetic products  represents a potential risk to human health. 
Its use in cosmetic products should  therefore  be prohibited. Consequently, 
Chloroacetamide should be deleted from Annex V to Regulation (EC) No 1223/2009 
and added to the list of substances prohibited in cosmetic products of Annex II to 
Regulation (EC) No 1223/2009.  
(4) Regulation (EC) No 1223/2009 shoul d therefore be amended accordingly.  
(5) The application of the restriction on Chloroacetamide should be deferred to allow 
industry to make the necessary adjustments to product formulations. In particular, 
undertakings should be granted nine months to place on the market compliant products 
and to withdraw from the market non -compliant products after the entry into force of 
this Regulation.  
(6) The measures provided for in this Regulation are in accordance with the opinion of 
the Standing  Committe e on Cosmetic Products,  
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 OJ No 196/1, 16.8.1967, p. 234.  
3 SCCS/1360/10, http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_053.pdf.  EN 3   EN HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes II and V to Regulation (EC) No 1223/2009 are amended in accordance with the 
Annex to this Regulation.  
Article 2  
This Regulation shall apply from [date = 9 months after the publication d ate] in relation to 
points (1) and ( 2) of the Annex.  
Article 3  
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  
 Jean -Claude Juncker