Restrictions for UV filters BHT Acid Yellow

As of November 10, 2022., the European Commission adopted official amendments to the Regulation and amendments to Annexes III and VI of the EU Regulation on cosmetic products.

Annex III is a list of substances that can be used in cosmetics only according to certain restrictions specified in it. Annex VI includes UV filters permitted for use in cosmetics. With this in mind, the European Commission notified the World Trade Organization (WTO) on 12 April 2022 of a draft Regulation containing the following changes.

BHT-Butyl hydroxytoluene

Back in 2019, the European Commission included BHT in the list of substances that the Scientific Committee on Consumer Safety (SCCS) must evaluate as a priority due to their potential endocrine disrupting properties. In view of this, in December 2021, the final opinion 1636/21 on BHT was issued. The European Commission has transferred the conclusions of the Committee into this draft Regulation.

BHT- Butyl Hydroxytoluene will be allowed:

• In mouthwash products, maximum up to 0.001 %
• In toothpastes up to 0.1%
• In other preparations that remain on the skin and are washed off the skin up to 0.8%

Color Acid Yellow

The draft Regulation limits the use of Acid Yellow to non-oxidative hair dye products in a maximum concentration of 0.5%. Any other use not expressly regulated will not be permitted.

The SCCS confirmed this use as safe in its final opinion 1631/21 of July 2021.

The new limits for BHT and Acid yellov 3 will start to apply six months after the entry into force of the Regulation. Moreover, products placed on the EU market before that date may be available for another six months (12 months from the entry into force of the Law).

UV Filters

Lower concentrations of Homosalat

Homosat can only be used in face products, with the exception of spray products with propellants up to a maximum concentration of 7.34%. Application deadlines are as follows: 24 months from the entry into force of the draft Marketing Regulation; 30 months after entry into force for making available.

The European Commission has provided a longer transition period for this UV filter because cosmetic brands should reformulate their sunscreen products with Homosalat and test their SPF effectiveness, an ongoing process.

New UV Filter Piperazine

HAA299 - regular or in nano form is a safe UV filter up to a maximum concentration of 10% The sum of the concentrations of piperazine in regular and nano form when used together must not exceed a concentration of 10%. Piperazine in nano form must meet additional requirements: Purity ≥97% Medium-sized particles D50 ≥ 50 nm With this official announcement, we can confirm that the restrictions will apply during the following periods: Regarding butylated hydroxytoluene and acid yellow 3, from 1 July 2023 for placing on the market and from 1 January 2024 for placing on the market (released for distribution or use).

For Homosalat from January 1, 2025 for marketing, and from July 1, 2025 for marketing. Finally, Piperazine in classic and nano forms will be allowed as a UV filter from November 31, 2022.