SAFEGUARDS | Cosmetics, Personal Care & Household NO. 149/16

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The European Commission published Commission Regulation (EU) 2016/1121 on July 11, 2016 amending Annex V of Regulation (EC) No. 1223/2009. The entry for Ethyl Lauroyl Arginate HCl as a preservative is updated.

Ethyl Lauroyl Arginate HCl was allowed at a maximum concentration of 0.4% by weight as a preservative in cosmetic products, except lip products, oral products and spray products. Following opinions SCCS/1519/13 and SCCS/1543/14 from the Scientific Committee on Consumer Safety (SCCS), Ethyl Lauroyl Arginate HCl is authorized at a maximum concentration of 0.15% by weight in a new category: Mouthwashes, except for children under the age of 10.

The new entry becomes effective July 31, 2016.

Table 1: Annex V of Regulation (EC) No. 1223/2009 is amended as follows:

Reference number Substance identification
Chemical name/INN Name of Common Ingredients Glossary CAS number EC number
a b c d e
‘58 Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride (*) Ethyl Lauroyl Arginate HCl 60372-77-2 434-630-6


Reference number Conditions Wording of conditions of use
and warnings
Product type, body parts Maximum concentration in ready for use preparation Other
a f g h i
‘58 (a) Mouthwashes (a) 0,15 % (a) Not to be used in preparations for children under 10 years of age (a) Not to be used for children under 10 years of age
(b) Other products (b) 0,4 % (b) Not to be used in lip products, oral products (other than mouthwashes), and spray products

(*) For other uses than preservatives, see Annex III, entry No 197.’

It is crucial that all cosmetic, personal care and household products are safe, effective and stable. SGS provides testing, inspection, auditing and consulting services to manufacturers, distributors and importers to ensure a high level of product quality in every area. Our state of the art laboratories offer custom-made solutions for chemical, biophysical, microbiological, stability and biological aspects. We also have extensive capabilities in performance testing, claim support studies and consumer panels. Our testing is conducted according to customer specific or recognized standard methods, some of which were developed by SGS. Our cosmetic safety assessors and other technical experts can support customers by making sure new products comply with regulatory requirements.

Reference Sources:

[1] Commission Regulation (EU) 2016/1121 on 11 July 2016

[2] Scientific Opinion SCCS/1519/13 on Ethyl Lauroyl Arginate HCL – submission IV

[3] Scientific Opinion SCCS/1543/14 Addendum to the SCCS Opinion on Ethyl Lauroyl Arginate HCL – SCCS/1519/13

For enquiries, please contact:

Queenie Tse
Technical Service Executive, Cosmetics, Personal Care & Household

t: +852 2765 3672

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