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Expert opinion

Addendum to the opinion on Ethyl lauroyl arginate HCl - SCCS/1519/13

Final Opinion

Details

Publication date
25 March 2015
Author
Scientific Committee on Consumer Safety (SCCS)

Description

WG on Preservatives
SCCS members:U. Bernauer, P.J. Coenraads, G. Degen, M. Dusinska, W. Lilienblum, A. Luch, E. Nielsen, Th. Platzek (rapporteur), S. Ch. Rastogi (chairman), Ch. Rousselle, J. van Benthem
External experts: A. Bernard A. Giménez-Arnau, T. Vanhaecke
Contact:SANTE-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1519/13
Adopted on: 16 December 2014

Conclusion of the opinion:

1) In the light of the data provided, does the SCCS consider that Ethyl Lauroyl Arginate HCl is still safe for the consumers at current use in all cosmetic product including oral products, considering the exposure from other sources, such as food?

The SCCS considers Ethyl lauroyl arginate HCl safe for use as a preservative, when used up to a maximum concentration of 0.15% in mouthwashes, though not in oral cosmetic products as a whole.

2) In particular does the SCCS consider that Ethyl Lauroyl Arginate HCl is safe considering the specific age groups who might be particularly susceptible to the effects of total exposure to Ethyl Lauroyl Arginate HCl, used in both cosmetic and food products?

The exposure estimations provided suggest that for the subgroup ‘Children’ the ADI may be exceeded when adding food exposure (using the 95th exposure percentile) and cosmetic exposure. However, the amounts stemming from dermal exposure should not be added when using the ADI based on the low NOAEL used by EFSA. To the maximum amount of 0.442 mg/kg bw/day (food exposure, 3 year old children, 12 kg body weight, 95th exposure percentile) only 0.29 mg/kg bw/day from oral exposure should be added resulting in a total exposure of 0.73 mg/kg bw/day. In contrast, when considering 9 year old children (body weight 25 kg) the oral exposure from cosmetics would be 0.14 mg/kg bw/day and the sum would be 0.58 mg/kg bw/day. Both of these values (0.58 and 0.73 mg/kg bw/day) are not covered by the ADI. The SCCS considers the use of Ethyl Lauroyl Arginate in mouthwashes for children at the concentration of 0.15% for longer time periods as not safe.

3) Does the SCCS have any further scientific concerns with regard to the use of Ethyl Lauroyl Arginate HCl in cosmetic products?

As no human data concerning local toxicity of Ethyl lauroyl arginate HCl in toothpaste are available, the safety of Ethyl lauroyl arginate HCl in toothpaste cannot be assessed.

Keywords:

SCCS, scientific opinion, preservative, P95, Ethyl lauroyl arginate HCl, Regulation 1223/2009, CAS: 60372-77-2, EC: 434-630-6

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Addendum to the opinion on Ethyl lauroyl arginate HCl (P95), SCCS/1543/14, 16 December 2014.

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