3 months ago (On April 7, 2019), the Scientific Committee on Consumer Safety of the European Commission has published its final opinion on HEPB, the Hydroxyethoxyphenyl Butanone.
The Scientific Committee on Consumer Safety (SCCS) is one of the independent scientific committees managed by the Directorate-General for Health and Consumer Protection of the European Commission, which provide scientific advice to the Commission on issues related to non-food issues. It is the successor to both the Scientific Committee on Consumer Products (SCCP) and the Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP).
The committee said Hydroxyethoxyphenyl Butanone is safe to use as a preservative in rinse-off, oral care, and leave-on cosmetic products with a maximum concentration of 0.7% with regard to eye irritation.
However, it doesn’t necessarily mean that a higher concentration of Hydroxyethoxyphenyl Butanone is safe to be used in cosmetics products.
Early in 2017, the use of Hydroxyethoxyphenyl Butanone (HEPB) as a cosmetic preservative in rinse-off, oral care, and leave-on cosmetic products with a maximum concentration of 2.0 % under an aggregate exposure scenario for cosmetics is not considered safe. It is of note that a maximum concentration of 2.0 % under an aggregate exposure scenario for cosmetics could be considered safe if more reliable and supporting data on in vitro dermal penetration was provided.
Final Modification of Annex V (authorized preservatives of HEPB) is expected to be adopted during the 4th quarter of 2019.
Chemical and Physical Specifications of Hydroxyethoxyphenyl butanone
INCI name: Hydroxyethoxyphenyl butanone (INCI)
Chemical names: 4-(3-ethoxy-4-hydroxyphenyl) butan-2-one
Trade Names: Ethylzingerone, R0069279A, HEPB
EC: not assigned
Molecular Formula: C12H16O3
Molecular weight: 208.25
Specifications/purity: 98% min
Solubility: 7.59 g/L at 20°C ± 0.5 °C.
Residual solvents: < 0.1 % by GC
Appearance/color: (white powder or crystals) or as a pale yellow liquid form under different temperature.
Melting point: 41 ± 2°C (DSC method)
Boiling point: 328 ± 2°C at 100 to 102 kPa
Hydroxyethoxyphenyl butanone Stability
Hydroxyethoxyphenyl butanone is stable over 2 months at 45oC in hydroalcoholic solution at 0.5 g/100 ml.
It is sensitive to photostress but resistant to oxidative, heat, acid or basic stresses. A determination was performed for the three batches using batch R0069279A 001L-001 as reference.
Function and uses of Hydroxyethoxyphenyl butanone
The ingredient HEPB is intended to be used specifically as a preservative in rinse-off, oral care, and leave-on cosmetic products up to 0.7% instead of 2%.
Background information about HEPB ingredient
Ethylzingerone with INCI name ‘Hydroxyethoxyphenyl Butanone’ (HEPB) Cosmetics Europe No P98 – CAS No 569646-79-3 is a cosmetic ingredient not regulated under Cosmetic Regulation No 1223/2009 with the function as a skin conditioning agent.
In September 2015, the Commission’ services received a dossier from industry to support the safe use of Hydroxyethoxyphenyl Butanone (HEPB) when used as a preservative in rinse-off, oral care, and leave-on cosmetic products.
According to the above-mentioned dossier, the safety profile of HEPB has been studied in preclinical studies conducted according to Good Laboratory Practices and following OECD guidelines whenever available. They were conducted using HEPB from batches which were well characterized analytically with a minimum purity of 95.9%. In China, the assay/purity of commercial quantity of Hydroxyethoxyphenyl Butanone is now 99% min.