Butylphenyl Methylpropional – is the aggregate exposure safe?
Butylphenyl Methylpropional is an aromatic aldehyde used as a fragrance compound in cosmetic and non-cosmetic products. New opinions regarding the safety of this fragrance ingredient have been recently published.

Date

Liliana Teles

Liliana Teles

Regulatory Affairs Manager

BUTYLPHENYL METHYLPROPIONAL AND ITS USE IN COSMETICS

Butylphenyl Methylpropional, commonly known as Lilial or p-BMHCA, is a synthetic fragrance ingredient widely used in different types of cosmetics. Butylphenyl Methylpropional is also used in several non-cosmetic products, like household cleaners and detergents.  

Butylphenyl Methylpropional is included in Annex III (entry 83) of the European Cosmetics Regulation No. 1223/2009.  This means that its presence in the finished product must be indicated in the list of ingredients on the label when its concentration exceeds 0.01% in rinse-off products and 0.001% in leave-on products. 1,2

The Research Institute for Fragrance Materials Expert Panel (REXPAN) has evaluated the safety of this fragrance ingredient and an International Fragrance Association (IFRA) Standard has been established. Due to its potential for sensitization, the use of Butylphenyl Methylpropional is restricted in fragrances. IFRA recommends a safe concentration limit for Butylphenyl Methylpropional when it is used in the specific categories of cosmetic products (as developed by IFRA). For example, according to IFRA’s dossier submitted to the Scientific Committee on Consumers Safety (SCCS), Butylphenyl Methylpropional may be used at a maximum level of 1.42% in hydroalcoholic-fragrances, at 0.09% in deodorants and at 0.05% in face and hand creams. 2,4

SAFETY ASSESSMENTS OF BUTYLPHENYL METHYLPROPIONAL

According to the 2015 SCCS’s opinion on Butylphenyl Methylpropional, BMHCA poses a risk of inducing skin sensitization in humans. 4,5

In 2017, the SCCS reviewed the safety of BMHCA in cosmetic products. Butylphenyl Methylpropional as a net compound revealed to be irritating to the skin and eyes of rabbits. The SCCS concluded that, “on individual product basis, Butylphenyl Methylpropional 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”. Nevertheless, the SCCS considered the aggregate exposure, arising from the use of different product types together, and concluded that Butylphenyl Methylpropional at the proposed concentrations cannot be considered safe. 3

The European Chemicals Agency Risk Assessment Committee (RAC) evaluated a classification proposal on Butylphenyl Methylpropional to be considered as Toxic to Reproduction (Repr. 2 – Reproductive Toxicity class 2). RAC concluded that this fragrance ingredient should be rather categorized as Repr. 1B. 6 This classification means that Butylphenyl Methylpropional would be prohibited in all cosmetic products (expected in the first semester of 2021).

References:

  1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009, on cosmetic products.
  2. IFRA 48th Amendment – p-tert-Butyl-alpha-methylhydrocinnamic aldehyde (p-BMHCA).
  3. Scientific Committee on Consumer Safety (SCCS) – Opinion on the safety of Butylphenyl Methylpropional (p-BMHCA) in cosmetic products – Submission II – 2017
  4. Scientific Committee on Consumer Safety (SCCS) – Opinion on Fragrance allergens in cosmetic products, 2012
  5. Scientific Committee on Consumer Safety (SCCS) – Opinion on Butylphenyl Methylpropional (BMHCA), 2015
  6. European Chemicals Agency (ECHA) – Substance Infocard: 2-(4-tert-butylbenzyl)propionaldehyde.

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