SCCS Final Opinion on the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products – Submission II
The ingredient Butylphenyl Methylpropional with the CAS No. 80-54-6 (p-BMHCA) is a synthetic fragrance compound used in aftershave lotions, bath products, bubble baths, cleansing products, hair care products, moisturizers, perfumes and colognes, shampoos and skin care products.
It is currently regulated for labelling purposes in Annex III entry 83 of the Cosmetics Regulation No 1223/2009 and its presence must be indicated in the list of ingredients on the labels when its concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products.
A mandate has been issued by the European Commission for the SCCS (Scientific Committee on Consumer Safety) to evaluate the safety of this ingredient largely used in cosmetic but also non-cosmetic products.
On the 10thMay 2019, the SCCS issued its final opinion on the matter after publishing its first opinion in 2015 in which it concluded that “BMHCA poses a risk of inducing skin sensitization in humans”. In the meantime, the IFRA Association presented a dossier to defend the use of this ingredient.
According to the SCCS final opinion, “On individual product basis, Butylphenyl methylpropional (p-BMHCA) (CAS 80-54-6) with alpha-tocopherol at 200 ppm, can be considered safe when used as fragrance ingredient in different cosmetic leave-on and rinse-off type products. However, considering the first-tier deterministic aggregate exposure, arising from the use of different product types together, Butylphenyl methylpropional at the proposed concentrations cannot be considered as safe”.
Additionally, the SCCS expressed its concern about a higher exposure scenario of users to this substance due to its presence in some non-cosmetic products such as household cleaners and detergents.
Manon Prado
RA Department
July 26, 2019
Obelis at Your Service
With more than 25 years of regulatory experience, it will be our pleasure to help and advise you on EU cosmetics regulatory updates, SCCS opinions and restricted or banned cosmetic ingredients in the EU. If you would like to know more about cosmetics products regulatory compliance, please contact us.