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Expert opinion

Revision of the opinion on Butylphenyl methylpropional (BMHCA)

Final Opinion

Details

Publication date
16 March 2016
Author
Scientific Committee on Consumer Safety (SCCS)

Description

WG on Cosmetic ingredients
SCCS members:Q. Chaudhry, P.J. Coenraads, M. Dusinska, W. Lilienblum, E. Nielsen, T. Platzek, Ch. Rousselle, J. van Benthem
External experts: A. Bernard, L. Bodin, J. Duus-Johansen, J. Ezendam, A. Giménez-Arnau, A. Luch, E. Mirkova, E. Panteri, T. Vanhaecke, A. Varvaresou
Contact:SANCO-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1540/14
Adopted on: 16 March 2016

Conclusion of the opinion:

The applicant was neither able to submit reliable data on the actual usage of BMHCA in the different product groups placed on the European market, nor clearly defined unambiguous limits in the finished products to be assessed by SCCS.

1. Does the SCCS consider 2-(4-tert-butylbenzyl)propionaldehyde (BMHCA) safe for use as fragrance ingredient in cosmetic leave-on and rinse-off type products in a concentration limit(s) according the ones set up by IFRA?

The SCCS is of the opinion that BMHCA is not safe for use as fragrance ingredient in cosmetic leave-on and rinse-off type products, neither at concentration limits according to the ones set up by IFRA in 2013 (MoS = 3.6) nor at concentration limits as set up by IFRA in the revised proposal that has been submitted in 2015 belatedly (MoS = 53). In addition, no firm conclusion could be drawn on mutagenicity.

2. Does the SCCS have any further scientific concerns with regard to the use of 2-(4- tert-butylbenzyl)propionaldehyde (BMHCA) as fragrance ingredient in cosmetic leave-on and rinse-off type products?

BMHCA poses a risk of inducing skin sensitisation in humans. During the commenting period the applicant commented on the maximum use levels of BMHCA in the finished cosmetic product types. Also further information on genotoxicity was provided. It was also proposed to initiate an in vitro study on dermal penetration of 14CBMHCA through human skin (according OECD TG 428). A reassessment of 2-(4-tert-butylbenzyl)propionaldehyde (BMHCA) based on the new data is foreseen.

Keywords:

SCCS, scientific opinion, fragrance ingredients, Butylphenyl methylpropional, Regulation (EC) No. 1223/2009, CAS 80-54-6

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on the Butylphenyl methylpropional, 12 August 2015, SCCS/1540/14, revision of 16 March 2016

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