BHT, Acid Yellow 3, Homosalate, HAA299 and Resorcinol

Much has been said recently about the potential endocrine-disrupting properties of this substance. Therefore, the SCCS Committee took a closer look at BHT. In its opinion No. SCCS/1636/21, the committee concluded that BHT is a safe ingredient in cosmetics when used in the combined use of: mouthwash – with BHT content at a maximum concentration of 0.001%; toothpaste – in the maximum concentration of BHT = 0.1% and other rinse-off and leave-on products in the maximum concentration of BHT = 0.8%.
Therefore, BHT will be included in Annex III of the Cosmetics Regulation, i.e. the list of restricted substances. It will occupy the position 325 in that annex. Restrictions on the use of BHT in cosmetics will be in line with the SCCS opinion, i.e. it will be allowed to be used in:

Current data shows that Acid Yellow 3 can be safely used in non-oxidative hair dye products at concentrations on the scalp not exceeding 0.5%. This is reflected in the SCCS Opinion No. SCCS/1631/21, where it was concluded that above 0.5% this dye poses a potential risk to human health. Accordingly, Acid Yellow 3 will be included in Annex III under entry 326, where the use of this colorant in non-oxidative hair dye products will be limited to a concentration of 0.5%.

The transitional periods will be analogous to those for BHT, i.e. from July 1st, 2023 – a ban on placing on the market products that do not comply with the new requirements, and from January 1st, 2024 – a ban on making them available on the market.

Important! If this substance is used as a “standard colourant”, i.e. not in hair dyes, but e.g. in nail lacquers, Annex IV entry 82 still applies.

The SCCS opinion on Acid Yellow 3 can be found at the following link: https://health.ec.europa.eu/system/files/2022-08/sccs_o_253.pdf

Following the intervention of the cosmetics industry to ensure that consumers are adequately protected from the sun, the SCCS issued a further opinion SCCS/1638/21. It confirmed the safety of Homosalate at concentrations up to 7.34% when used in non-spray cream and pump spray facial products. Accordingly, the following amendments have been made to Annex VI, entry 3:

• the use of Homosalate is limited to facial products only (other than spray and pump spray),
• maximum allowed concentration of Homosalate in the above products = 7.34%.

Transitional periods: January 1st, 2025 – for placing products on the market and July 1st, 2025 – for making them available on the market.

Therefore, 2 new entries have been added to Annex VI:

• 33: Bis-(Diethylaminohydro­ xybenzoyl Benzoyl) Piperazine,
• 34: Bis-(Diethylaminohydro­ xybenzoyl Benzoyl) Piperazine (nano).

The maximum allowed concentration of both forms of HAA299 will be 10%, and in the case of combined use of Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine in the “regular” and nano form, their sum may not exceed 10%. In addition, only nanomaterials with the following properties are allowed for the nano form:

• purity ≥ 97%,
• median particle size D50 (50 % of the num­ ber below this diameter): ≥ 50 nm of number size distribution,
• not to be used in applications that may lead to exposure of the end user’s lungs by inhalation.

Finally, we have an amendment on resorcinol (INCI: Resorcinol) – a substance intended for colouring hair. This compound is restricted under the entry 22 in Annex III to Regulation 1223/2009.

What is this rectification about? The warning on the use of resorcinol for dyeing eyebrows has been deleted: ‘Do not use to dye eyelashes or eyebrows’. Thus, in the row for item 22, column i (a) in the case of oxidative hair dye products, the last sentence is replaced by the following: ‘Do not use to dye eyelashes’.

The regulation will enter into force on December 1st this year.