This regulation of 11 July 2016, published in Official Journal of the European Union on 12 July, amends Annex V (preservatives) to Cosmetics Regulation 1223/2009, to authorize Ethyl lauroyl arginate HCl in mouthwashes, except for children under the age of 10.
The whereas of regulation 2016/1121
(1) The substance Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride, which has been assigned the name Ethyl Lauroyl Arginate 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 Regulation (EC) No 1223/2009. Under entry 58 of Annex V, Ethyl Lauroyl Arginate HCl is allowed as a preservative 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 Arginate HCl in oral products on 19 September 2013 ( revised on 12 December 2013 ) and an addendum to that opinion on 16 December 2014 ( revised on 25 March 2015 ).
(3) The SCCS concluded that Ethyl Lauroyl Arginate HCl is safe for use as a preservative in mouthwashes at a maximum concentration 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 3 to 9 may be exceeded, when adding food exposure and cosmetic exposure. The SCCS thus concluded that …
