EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2015) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of 
the Council on cosmetic products  
(Text with EEA relevance)    
EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of 
the Council on cosmetic products  
(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 1223/2009 of the European Parliament and of the 
Council of 30 November 2009 on cosmetic products1, and in particular Article 31 (2) thereof,  
Whereas:  
(1) The substance Ethyl -N-alpha -dodec anoyl -L-arginate hydrochloride , which has been 
assigned the  name Ethyl Lauroyl A rginate HCl under the International Nomenclature 
of Cosmetic Ingredients (INCI), is currently regulated in entry 197 of Annex III and in 
entry 58 of Annex V to Regulatio n (EC) No 1223/2009. Under entry 58 of Annex V, 
Ethyl L auroyl Arginate HCl is allowed as a preserva tive in cosmetic products , except 
lip products, oral products and spray products,  at a maximum concentration of 0 ,4 % 
w/w. 
(2) The Scientific Committee on Consumer Safety (SCCS) adopted a scientific opinion on 
the safety of Ethyl Lauroyl A rginate HCl in oral p roducts on 19 September 2013 
(revised on 12 December 2013)2 and an addendum to that opinion on 16 December 
2014  (revised on 25 March 2015)3. 
(3) The SCCS concluded that Ethyl L auroyl Arginate HCl is safe for use as a preservative 
in mouthwashes at a maximum co ncentration of 0 ,15 %  w/w, but not in oral products 
in general. The SCCS also considered that the exposure estimations suggested that the 
acceptable daily intake for children aged three to nine may be exceeded , when adding 
food exposure and cosmetic exposu re. The SCCS thus concluded that the  continuous  
use of Ethyl Lauroyl A rginate HCl as a preservative in mouthwashes at that 
concentration for children is not safe.  
(4) In light of that SCCS opinion, the Com mission considers that Ethyl Lauroyl A rginate 
HCl shoul d be allowed for use as a preservative up to a concentration of 0 ,15 %  w/w 
in mouthwashes, expect for children under the  age of ten.  
(5) Regulation (EC) No 1223/2009 should therefore be amended accordingly.  
(6) The measures provided for in this Regulation are in accordance with the opinion of 
the Standing  Committee  on Cosmetic Products , 
                                                 
1 OJ L 342, 22.12.2009 , p. 59.  
2 SCCS/1519/13, http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_138.pdf.  
3 SCCS/1543/14, http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_166.pdf.   
EN 3   EN HAS ADOPTED THIS REGULATION:  
Article 1  
Annex V to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this 
Regulation.  
Article 2 
This Regulation shall enter in to 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 Preside nt 
 Jean -Claude Juncker