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Friday, September 18, 2015Regulation

Butylphenyl methylpropional: 'Not safe' for SCCS

 © CosmeticOBS-L'Observatoire des Cosmétiques

This Opinion of SCCS has been adopted on 12 August 2015 by written procedure and has just been published. Its conclusion: the cosmetic fragrance ingredient Butylphenyl methylpropional is not safe. This opinion has been opened for comments until 10 November 2015, then until 31 December 2015.

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Background

 2-(4-tert-Butylbenzyl)propionaldehyde (BMHCA, INCI: Butylphenyl methylpropional, CAS: 80-54-6) is a fragrance ingredient used in many compounds in cosmetic products.
In October 2012 BMHCA has been introduced in the Registry of submitted Harmonized Classification and Labeling intentions', in view of a harmonized classification as CMR 2 (fertility).
In April 2013 the Commission has received a dossier by the International Fragrance Association (IFRA) on the safety assessment of BMHCA, intended to demonstrate the safety of this ingredient. IFRA recommends a safe concentration limit for BMHCA when it is used in the specific categories of cosmetic products.

For exhaustive background information, see the article
Fragrances, Hair dyes: 5 requests for Opinions by the SCCS (September 25, 2013)

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 and in oral products in a concentration limit(s) according the ones set up by IFRA ?

The SCCS is of the opinion that BMHCA is …

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