EC Amends the Restriction Limit on Ethyl Lauroyl Arginate HCl
SAFEGUARDS | Cosmetics, Personal Care & Household NO. 149/16
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|
|‘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
|Product type, body parts||Maximum concentration in ready for use preparation||Other|
|‘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.’
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