Omnibus Regulation 2019

A New Regulation on Ethyl Lauroyl Arginate HCl

On July 11th, 2016, the EU Commission published a new piece of legislation (Regulation EU No 2016/1121), which aims to allow the use of Ethyl Lauroyl Arginate HCl in mouthwashes under certain conditions. This new amendment to the EU Cosmetics Regulation (EC No 1223/2009) will enter into force on August 1st, 2016 and foresees no transitional period meaning that the implementation of this legal text will therefore be immediate.

Ethyl Lauroyl Arginate HCl (CAS 60372-77-2) is a preservative reported in Entry 58 of Annex V. Until now, this preservative was allowed at 0.4 % in all cosmetics at the exception of lip products, oral products and spray products. Based on a safety dossier submitted by the Industry, the Scientific Committee on Consumer Safety (SCCS) concluded that the use of Ethyl Lauroyl Arginate HCl is also safe in mouthwashes at 0.15 % except for products intended to children under 10 years of age.

These recommendations have been entirely transposed into the outline above regulation by the EU Commission. Furthermore, the use of Ethyl Lauroyl Arginate HCl in mouthwashes comes with an obligation to label the warning “Not to be used for children under 10 years of age”.

The ban of this preservative remains applicable to lip products, spray products and oral products (at the exception of mouthwashes).

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  • Frédéric Lebreux

    Dr. Frédéric Lebreux is Biorius's Chief Executive Officer and has worked in the cosmetic industry for more than 13 years. He is regularly invited as a speaker or Professor to cosmetic events.

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