BHT – Butylated Hydroxytoluene

Abstract

The Expert Panel for Cosmetic Ingredient Safety reviewed updated information that has become available since their original assessment from 2002, along with updated information regarding product types, and frequency and concentrations of use, and reaffirmed their original conclusion that BHT is safe as a cosmetic ingredient in the practices of use and concentration as described in this report.

The Expert Panel for Cosmetic Ingredient Safety first published the Final Report on the Safety Assessment of BHT (butylated hydroxytoluene) in 2002. ¹ The Expert Panel concluded that this ingredient is safe as used in cosmetic formulations. Data identified in the published literature^2-16 that have become available since the original review support the conclusion reached by the Expert Panel in 2002 publication. The Panel also reviewed updated information regarding product types and ingredient use frequencies as reported in the US Food and Drug Administration (FDA) Voluntary Cosmetic Registration Program (VCRP) database, ¹⁷ and the maximum use concentrations provided by the Personal Care Products Council (Council). ¹⁸ The Expert Panel determined to not reopen this safety assessment and reaffirmed the original conclusion that BHT is safe as a cosmetic ingredient in the present practices of use and concentration, as given in Table 1.

Table 1.

Current and Historical Frequency and Concentration of Use of BHT According to Duration and Exposure.

The reported frequency of use for this ingredient has increased significantly since the initial review was considered. According to VCRP data, BHT was reported to be used in 1709 formulations in 1998. ¹ In 2019, VCRP data indicate that BHT is used in 9485 formulations. ¹⁷ The current maximum concentration of use (0.5%) in leave-on products, ¹⁸ according to the results of the Council survey, is approximately the same as that reported in 1999 (0.5%). ¹

Although a substantial increase in frequency of use was reported, the lack of genotoxicity, systemic, and clinical effects continues to support the safety of this ingredient. According to the Expert Panel, BHT did not pose a toxicological risk as used in cosmetics; and therefore, the original conclusion was reaffirmed.