Between November 14 and November 20, the EU Scientific Committee on Consumer Safety (SCCS) issued six new documents.
These publications follow the committee’s plenary meeting held on October 30.
Final Opinion on Tea Tree Oil: potential CMR classification and exemption from art. 15 ban
In 2023, ECHA’s RAC published an opinion classifying Tea Tree Oil as Repr. 1B under Regulation (EC) No 1272/2008 (CLP Regulation). Consequently, due to the potential ban of the ingredient under the conditions laid out in Article 15(2)(d) of Regulation (EC) No 1223/2009, the SCCS was asked to assess its safety in cosmetic products.
The final opinion confirms the conclusions of the preliminary opinion published in June 2025, stating that Tea Tree Oil is safe for use in cosmetic products up to the following maximum concentrations:
- 2.0% in shampoo
- 1.0% in shower gel
- 1.0% in face wash
- 0.1% in face cream
Additionally, the SCCS clarified that this opinion applies only to Tea Tree Oil whose chemical composition complies with the updated International Standard (ISO 4730:2017) in the finished cosmetic products.
It also stressed that the use of Tea Tree Oil in these dermally applied cosmetic products is intended exclusively for adults and must not involve aerosolised or sprayable formats that could result in inhalation exposure to airborne mist or droplets containing Tea Tree Oil.
Scientific Advice open for comments on BHA
Currently, Butylated Hydroxyanisole (BHA) (CAS No. 25013-16-5) is not regulated under the Cosmetics Regulation. According to the CosIng database, BHA is reported to function as an antioxidant and fragrance. Due to its potential endocrine activity, its safety in cosmetic products has been assessed by the SCCS.
In its preliminary opinion, which is open for comments until 19 January 2026, the SCCS considers the use of BHA in leave-on and rinse-off cosmetic products to be safe at concentrations up to 0.07%.
This opinion covers only dermal exposure and therefore applies solely to dermally applied products. It excludes oral care products or cosmetic products that may lead to inhalation exposure of the end user.
Scientific Advice on hair dyes Basic brown 16 and Basic blue 99
The hair dyes Basic Brown 16 (CAS No. 26381-41-9) and Basic Blue 99 (CAS No. 68123-13-7) have been evaluated by the SCCS in two separate documents. The SCCS does not consider either substance safe for use in non-oxidative hair dye formulations, as the weight of evidence indicates potential mutagenic and genotoxic effects.
Currently, neither of these hair dyes is included in the positive list of hair dyes permitted for use in cosmetic products under Annex III.
Both Scientific Advice documents are open for comments until January 19, 2026.
Preliminary Opinion on Cannabidiol (CBD)
Currently, CBD as such is not regulated under the EU Cosmetics Regulation. However, entry 306 of Annex II to the Regulation prohibits the use of “Narcotics, natural and synthetic: all substances listed in Tables I and II of the Single Convention on Narcotic Drugs of 30 March 1961” in cosmetic products.
On 19 November 2020, the Court of Justice of the EU (CJEU) issued a judgment in Case C-663/18 concerning the legal status of cannabidiol. The Court concluded that the CBD in question should not be considered a narcotic drug under the 1961 UN Single Convention. Nonetheless, the CJEU noted that legislation restricting the marketing of CBD may be justified to protect public health, provided that such limitations do not exceed what is necessary for that purpose.
In light of the CJEU ruling and the growing number of cosmetic products containing CBD, the safety of CBD and the possible unintentional presence of other cannabinoids, including THC, has been under evaluation.
The SCCS preliminary opinion, open for comments until 21 January 2026, assessed the following:
- CBD is safe at concentrations of up to 0.19% in dermal and oral cosmetic products, whether used individually or in combination.
- THC impurities are safe at concentrations up to 00025% in dermal and oral cosmetic products, whether used individually or in combination.
This opinion does not cover cosmetic products that may result in inhalation exposure of the end user.
Scientific Advice on the safety of Thiomersal and Phenylmercuric salts as preservatives in cosmetic products
Currently, Thiomersal and phenylmercuric salts (including borate) are listed in Annex V as permitted preservatives for use in cosmetic products at specific concentrations, despite the general prohibition of mercury compounds under Annex II.
According to the new SCCS Scientific Advice, which is open for comments until 21 January 2026, these mercury compounds are not considered safe at the concentration levels currently allowed in cosmetic products.
Additionally, the SCCS notes that the potential risk to human health is further increased by exposure to mercury compounds from sources other than cosmetic products.
Do you have questions on compliance of cosmetics in the EU, UK, USA, and Canada? Contact us here or at coslaw@obelis.net.
References
SCCS. (2025). Final Opinion on Tea Tree Oil. Retrieved on 14 November 2025.
SCCS. (2025). Scientific advice open for comments on Butylated Hydroxyanisole (BHA) – deadline for comments: 19 January 2026. Retrieved on 17 November 2025.
SCCS. (2025). Scientific advice open for comments on hair dye ‘Basic Brown 16’ (C009) – Submission V ter. (deadline: 19 January 2026). Retrieved on 17 November 2025.
SCCS. (2025). Scientific advice open for comments on hair dye ‘Basic blue 99’ (C059) – Submissions IV & V (deadline for comments: 19 January 2026). Retrieved on 17 November 2025.
SCCS. (2025). Preliminary Opinion open for comments on Cannabidiol (CBD) used in cosmetic products (deadline for comments: 21 January 2026). Retrieved on 19 November 2025.
SCCS. (2025). Preliminary Opinion open for comments on the safety of Thiomersal and Phenylmercuric salts as preservatives in cosmetic products (deadline: 21 January 2026). Retrieved on 19 November 2025.
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