At its plenary meeting on 6 June 2017, the SCCS approved a mandate from the European Commission. As announced in a previous Opinion of the experts committee, the safety of this fragrance ingredient, first declared unsafe for a use in cosmetic products, will be reassessed.
Background
The substance 2-(4-tert-Butylbenzyl)propionaldehyde (BMHCA, Lysmeral) CAS No. 80-54-6 with INCI name Butylphenyl methylpropional is a fragrance ingredient used in many compounds for cosmetic products as well as in non-cosmetic products.
Butylphenyl methylpropional (BMHCA) is currently regulated for labelling purposes in Annex III entry 83 of the Cosmetics Regulation No 1223/2009 when present in a concentration above 10 ppm for leave-on products and above 100 ppm for rinse-off products.
Following a proposal for a harmonised classification as Toxic for Reproduction 2 substance under Regulation (EC) No 1272/2008, a dossier on the safety assessment of BMHCA was submitted to the Commission by the International Fragrance Association (IFRA) in April 2013 (Submission I).
The SCCS issued the opinion in 2015 (SCCS/1540/14 Revision of 16 March 2016) on the safety of Butylphenyl methylpropional (BMHCA) in cosmetic products concluding that:
‘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 = .6) nor at concentration limits as set up by IFRA in the revised proposal that has been submitted in 2015 belatedly (MoS = 53). In …
