Ethyl lauroyl arginate HCl had been added to the list of preservatives allowed in cosmetic products in 2010. However, it had been banned for use in lip products, oral products and spray due to mucosal and respiratory tract irritation potential. Following a request by the industry, requiring an extension of its use in oral products, the European SCCS experts answered: yes, but only in mouthwashes.
This Opinion has been modified by the SCCS on December 16, 2014:
see the article
.
Background
Ethyl lauroyl arginate HCl (CAS 60372-77-2) is currently listed in the Cosmetics Regulation in the Annex III of substances submitted to restrictions: it shall not be used at a concentration higher than 0.8% in soaps, anti-dandruff shampoos and deodorants other than in spray cans when used for purposes other than as an inhibitor of the growth of micro-organisms in the product. It is also listed in the Annex V (Regulation 1223/2009): as a preservative, its limit is 0.4% of the finished product, and it shall not be used in lip products, oral products and spray.
In its previous Opinions, the SCCS had written that regular use of toothpaste and possible additional use of a mouthwash containing ethyl lauroyl arginate HCl could cause local mucosal irritation.
A file has been submitted by the industry in September 2012: this submission is intended to demonstrate the safety of the ingredient ELA for use as preservative in oral products at a level up to 0.15%.
The SCCS had to answer two questions:
1) In the light of the data provided, does the SCCS consider that Ethyl Lauroyl …
