New SCCS opinion on Butylated hydroxytoluene (BHT)

New concentration limits proposed by SCCS for BHT in cosmetic products


Butylated Hydroxytoluene (BHT) is a lipophilic organic compound, a synthetic antioxidant widely used in multiple sectors, including food additives, cosmetics and personal care products, pharmaceuticals, plastics/rubbers and other petroleum products. Butylated hydroxytoluene is reducing the free-radical induced damage and spoilage; therefore, it helps maintain the properties and performance of products when exposed to air.

BHT is not currently regulated under the Cosmetics Regulation, however, it is included in the European database for information on cosmetic substances and ingredients (CosIng) with the reported function of antioxidant and fragrance.

On 7th November 2018, the Commission adopted the review of Reg. (EC) 1223/2009 on cosmetic products regarding substances with endocrine disrupting (ED) properties and concluded that the Regulation provides the adequate tools to regulate the use of cosmetic substances such as ED.

At the beginning of 2019, the Commission carried out a public call of data for 28 potential EDs substances, including BHT. Following the data collection, the commission began asking for opinions from the SCCS about the safety of those substances. In March 2021, the SCCS was asked to evaluate BHT safety, also considering data provided by stakeholders during the call for data.

On 3rd December 2021 the SCCS released its final opinion about BHT, which establishes the safety of BHT for human health within these limits:

  • maximum concentration up to 0,001% in mouthwash;
  • maximum concentration up to 0,1% in toothpaste;
  • maximum concentration up to 0,8% in other rinse-off and leave-on products.

BHT is also considered safe for combined use of mouthwash at a concentration of 0.001%, toothpaste at a concentration of 0.1% and other leave-on and rinse-off products at the concentration of 0.8%.

This opinion, together with the next ones that will be published in the coming months, is expected to lead the Commission to amend the Regulation annexes.