In view of its forthcoming CLH classification as a reprotoxic substance (and therefore CMR), the industry has submitted a dossier in defense of the safe use of Tea tree oil. The SCCS has just assessed the dossier and published its preliminary Opinion. It is open to comments until August 18, 2025.
Background
The European Risk Assessment Committee (RAC) of ECHA issued in February 2024 (adopted in November 2023) an opinion recommending among others a classification for TTO as “Reprotoxic of Category 1B (H360Fd)”.
In August 2024, the Commission services received a dossier to defend the safe use of Tea Tree Oil (CAS/EC No.68647-73-4 /285-377-1) as an ingredient with anti-seborrheic and antimicrobial function in rinse-off and leave-on cosmetic products according to Article 15(2) of the Cosmetics Regulation (EC) No.1223/2009.
For an exhaustive background information, see the articles
• Proposed CLH classification for Tea tree extract and essential oil, CosmeticOBS, 5 December 2022
• Tea Tree EO, HEMA and HMPA: ECHA’s RAC opinions on the proposed CLH classifications, CosmeticOBS, 11 December 2023
• Fragrances: three requests for Opinion to the SCCS, CosmeticOBS, 14 October 2024
The SCCS Opinion
(1) In light of the data provided and taking under consideration the possible classification as “Repr.1B” under Regulation (EC) No.1272/2008 (CLP Regulation) and the conditions laid out in Article 15 (2) (d) of the Regulation (EC) No.1223/2009, does the SCCS consider TTO safe when used as an anti-seborrheic and anti-microbial agent in rinse-off and leave-on cosmetic products up …
