Monday, October 4, 2021SCCS

BHT: the SCCS preliminary Opinion

BHT : l'Opinion préliminaire du CSSC

Following the mandate given by the European Commission to the SCCS in the context of the safety assessment of substances with potential endocrine disrupting properties, the Scientific Committee has just published its preliminary Opinion on BHT. It was adopted by written procedure on 27 September 2021 and is open for comments until 23 November 2021.

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Background

BHT (Butylated hydroxytoluene) (CAS No. 128-37-0, EC No. 204-881-4) is a synthetic antioxidant widely used in a variety of industries, including cosmetics. It is generally used as an antioxidant in a range of concentrations (0.0002 - 0.8%) in a wide range of product types, both dermally applied and sprayable. It is not currently regulated under Cosmetics Regulation 1223/2009.
During the call for data, stakeholders submitted scientific evidence to demonstrate the safety of BHT. The Commission asked the SCCS to carry out a safety assessment on the basis of the information provided.

For an exhaustive background information, see the articles
Endocrine disruptors: 2nd call for data from the European Commission, CosmeticOBS, 22 February 2021
Endocrine disruptors: 5 new requests for SCCS Opinions, CosmeticOBS, 15 March 2021

Opinion

1. In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of BHT (Butylated hydroxytoluene), does the SCCS consider BHT safe:
(a) when used in mouthwash up to the maximum concentration of 0.001% and in toothpaste up to the maximum concentration of 0.1% ?

On the basis of a safety assessment, and considering the concerns related to potential endocrine disrupting properties …

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