SCCS OPINION on Butylated Hydroxytoluene (BHT) - SCCS/1636/21 - Final version

International audienceSCCS OPINION on Butylated Hydroxytoluene (BHT) - SCCS/1636/21 - Final versionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document by written proccedure on 2 December 2021Mise en Ligne le 3 Décembre 2021https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_257.pdfAbstractButylated Hydroxytoluene (BHT)SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum (Rapporteur), E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: A. Koutsodimou, W. Uter, N. von GoetzContact: SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1636/21Adopted on: 2 December 2021Conclusion of the 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 of BHT, the SCCS is of the opinion that BHT is safe as an ingredient up to a maximum concentration of 0.001% in mouthwash and 0.1% in toothpaste. (b) when used in other leave on and rinse-off products up to a maximum concentration of 0.8 % ?On the basis of a safety assessment, and considering the concerns related to potential endocrine disrupting properties of BHT, the SCCS is of the opinion that BHT is safe as an ingredient up to a maximum concentration of 0.8% in other leave-on and rinse-off products.BHT is also considered safe for a 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%.(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of BHT (Butylated hydroxytoluene) in cosmetic products?/ (3) Does the SCCS have any further scientific concerns with regard to the use of BHT (Butylated hydroxytoluene) in cosmetic products?The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of BHT for the environment.Keywords:SCCS, scientific opinion, Butylated hydroxytoluene (BHT), CAS No 128-37-0, EC No 204-881-4, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), scientific opinion on Butylated hydroxytoluene (BHT), preliminary version of 27 September 2021, final version of 2 December 2021, SCCS/1636/21