What’s new in the near future in the cosmetics law? This time, the changes concern as many as 5 substances: BHT, Acid Yellow 3, Homosalate, HAA299 and Resorcinol. If you want to know more details of the new Regulation 2022/2195 of November 10th, 2022, I invite you to read the post below.
BHT
BHT, or butylated hydroxytoluene, 2,6-di-tert-butyl-4-methylphenol, INCI name: Butylated Hydroxytoluene, is a commonly used synthetic antioxidant that helps to maintain the durability and functional properties of cosmetics.
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:
- mouthwashes – at maximum concentration = 0.001%;
- toothpastes – concentration max. = 0.1%;
- other leave-on and rinse-off products – up to a concentration of max. 0.8%.
Change dates? From the 1st of July 2023, cosmetic products containing BHT and not complying with the new requirements will not be allowed to be placed on the Union market. However, from January 1st, 2024, it will not be possible to make BHT products that do not meet the requirements set out in the restrictions available on the market.
Link to SCCS opinion: https://health.ec.europa.eu/system/files/2022-08/sccs_o_257.pdf
Acid Yellow 3
Acid Yellow 3 dye is another substance that will be subject to changes in the conditions of use in cosmetics. Until now, this substance was listed in item 82 of Annex IV to Regulation 1223/2009. Therefore, Acid Yellow 3 could be used as a colorant in cosmetic products without any maximum concentration.
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
Homosalate
UV filters have also been included in the new regulation. Including Homosalate – a filter that appears in the position 3 of Annex VI of the cosmetic regulation. This compound can currently be used as a sunscreen in cosmetic products at a maximum concentration of 10%.
Due to the potential endocrine-disrupting properties of Homosalate, the SCCS issued a scientific opinion No. SCCS/1622/20, in which it concluded that this filter, in currently permitted concentrations in cosmetic products, poses a potential threat to human health. The opinion describes that the use of this UV filter in cosmetics is safe for the consumer only at a maximum concentration of 0.5% in the final product.
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.
SCCS opinions on Homosalate can be found at the following links:
https://health.ec.europa.eu/system/files/2022-08/sccs_o_244.pdf
https://health.ec.europa.eu/publications/scientific-advice-safety-homosalate-cas-no-118-56-9-ec-no-204-260-8-uv-filter-cosmetic-products_en
HAA299
Annex VI will also include a new UV filter – HAA299 with the INCI name: Bis-(Diethylaminohydro xybenzoyl Benzoyl) Piperazine. The SCCS submitted 2 opinions on the safety of this compound: SCCS/1533/14 and SCCS/1634/2021, with the second opinion concerning HAA299 in nano form.
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.
These changes will enter into force on December 1, 2022.
Links to SCCS opinions:
https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_159.pdf
https://health.ec.europa.eu/publications/haa299-nano_en
Resorcinol
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.
Regulation 2022/2195 introduces a lot of changes to the cosmetics law. They concern a variety of substances used in cosmetics: the antioxidant Butylated Hydroxytoluene, Acid Yellow 3 and Resorcinol dyes, as well as 2 UV filters: Homosalate and Bis-(Diethylaminohydro xybenzoyl Benzoyl) Piperazine. Details of the new regulation can be found at the following link: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R2195&from=EN
