UK Proposal Amending the Cosmetics Regulation Notified to the WTO

UK Proposal Amending the Cosmetics Regulation Notified to the WTO

By Susana Planas MunGavin, BSc, MSc - Senior Regulatory Specialist, UL’s Supply Chain Insights

The proposal to amend Annex III on restricted ingredients of the UK Cosmetics Regulation was notified to the WTO on Oct. 27, 2023.  Comments can be submitted until Dec. 26, 2023.  After the assessment period, the proposed UK Statutory Instrument would be adopted on Jan. 16, 2024.  It would become effective on Oct. 6, 2024. By Feb. 6, 2025, any existing products not complying to the new restriction would need to be removed from the market (off-the-shelf).

The use of ingredients in cosmetic products is controlled through the Annexes. These include positive lists addressed under Annexes IV on approved colorants, Annex V on approved preservatives and Annex VI on approved UV filters or as negative lists, addressed under Annex II on prohibited ingredients and Annex III on restricted ingredients.  The proposed amendment concerns Annex III and would implement the opinion issued by the Scientific Advisory Group on Chemical Safety (SAG-CS) on the restricted use of Butylated hydroxytoluene (BHT) (CAS No. 128-37-0) in certain products. The restriction of BHT is not currently regulated under the Cosmetic Products Regulation UK No 1223/2009 (as amended). The proposed maximum permitted concentration limits for each product are as follows:

• toothpaste at 0.1%;
• mouthwash at 0.001%;
• leave-on oral care products at 0.001%;
• other leave-on and rinse-off products at 0.8%

The BHT proposed restriction would be in line with that of the EU Cosmetic Products Regulation. However, the restriction for leave-on oral care products at 0.001% would apply only in the UK.

Recommended action items

• Review the use of BHT in impacted products regulated under the proposed restriction of ingredients.
• If using BHT, ensure their concentrations are not exceeding the maximum permitted concentration listed in Annex III to the Cosmetics Regulation.
• Maintain an inventory of restricted ingredients in cosmetic products placed or made available on the market.

References

Final opinion of February 2023 of the Scientific Advisory Group on Chemical Safety (SAG-CS) on the restricted use of Butylated hydroxytoluene (BHT)

UK Cosmetics Regulation 2019 retaining Regulation (EC) No 1223/2009