On 1 April 2024, the United Kingdom introduced an amendment to Annex III of the cosmetics regulation establishing a new restriction on the use of butylated hydroxytoluene (BHT) in cosmetic products.
One of the deadlines set for the new restrictions falls in February 2025.
Compliance deadlines
The key deadlines are as follows:
- 24 February 2025: Products containing BHT that do not meet the specified limits may no longer be placed on the UK market. Products placed on the market can be made available until 24 June 2025.
- 24 June 2025: Products already on the market must be brought into compliance or removed.
BHT restriction details
By the deadlines specified above, the concentration of BHT in cosmetic products must not exceed:
- 0.1% in toothpaste
- 0.001% in mouthwash and leave-on oral care products
- 0.8% in other leave-on and rinse-off products
Differences between UK and EU regulations
The EU restricted BHT in 2022 under Commission Regulation (EU) 2022/2195. While many limits align, a significant difference exists regarding leave-on oral care products:
- In the UK, the concentration of BHT in leave-on oral care products is capped at 0.001%.
- In the EU, the limit for such products is 0.8%, matching the restrictions for other leave-on and rinse-off products.
This divergence highlights the UK’s more stringent approach in specific product categories compared to the EU.
Do you have questions on compliance of medical devices in the UK? Contact us here.
Chiara Lai
Regulatory Intelligence & Innovation
21/01/2025
References:
EU Commission. (2009). Regulation (EC) No 1223/2009 of the European Parliament and of the Council on Cosmetic Products. Retrieved on 21/01/2025.
UK Government. (2024). The Cosmetic Products (Restriction of Chemical Substances) Regulations 2024. Retrieved on 21/01/2025.