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Monday, July 1, 2013SCCS

Three requests for SCCS opinions

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Topics: Ethyl Lauroyl Arginate HCl preservative, Phenylene Bis-Diphenyltriazine UV filter, as well as thioglycolic acid and its salts. The purpose is, for the first one, to widen its usage to oral hygiene products, for the second one, to allow its use as UV filter, and, for the latter, to study its use on lashes to make it compliant to the Regulation 1223/2009.

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Ethyl Lauroyl Arginate HCl

Ethyl lauroyl arginate HCl (CAS 60372-77-2) is currently listed 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%.

Therefore, the SCCS shall now answer two questions:
 1) In the light of the data provided, does the SCCS consider that Ethyl Lauroyl Arginate HCl is safe for the consumers, when used up to a maximum concentration of 0.15% …

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