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SCCS - Scientific Opinion on Tea Tree Oil (CAS/EC No. 68647-73-4 /285-377-1)
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Orientador(es)
Resumo(s)
The SCCS concludes the following:
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 to the maximum concentrations provided by the applicant?
The SCCS considers the use of Tea Tree Oil (TTO) as an anti-seborrheic and anti-microbial agent safe in four defended product types - up to the maximum concentration of 2.0% in shampoo, 1.0% in shower gel, 1.0% in face wash and 0.1% in face cream. The assessment has considered all available data, a possible classification as ‘Repr.1B’ under Regulation (EC) No 1272/2008, the conditions laid out in Article 15 (2) (d) of the Regulation (EC) No 1223/2009 including the aggregated exposure from the defended cosmetic products and non-cosmetics uses of TTO.
This Opinion is only applicable to:
• TTO with chemical composition that conforms to the updated International Standard (ISO 4730:2017) in the defended final cosmetic products.
• the use of TTO in the defended dermally applied cosmetic products exclusively for adults, and not in aerosolised or sprayable delivery formats that may give rise to inhalation exposure of the consumer to TTO through airborne mist/droplets of the TTO-containing products.
2. Alternatively, what is according to the SCCS, the maximum concentration considered safe for use of TTO in cosmetic products?
3. Does the SCCS have any further scientific concerns regarding the use of TTO in cosmetic products?
Based on the data provided, TTO is a moderate skin sensitiser.
The submission did not provide any data on the stability of TTO under the conditions of storage and use. Since the chemical composition of TTO may change due to exposure to light, heat, air and /or moisture, it is not clear how TTO will be stabilised in the final cosmetic products to prevent degradation/transformation of the components. The SCCS is therefore of the opinion that stability of TTO must be maintained in the final cosmetic products so that the components remain within the specifications of the updated ISO 4730:2017 standard. The new version of ISO standard (ISO 4730:2025), which relates to enantiomeric distribution parameters for α-terpineol in the essential oil of Melaleuca, terpinen-4-ol type (tea tree oil), should also be taken into account.
The SCCS mandate does not address environmental aspects. Therefore, this assessment has not covered the safety of TTO for the environment.
Descrição
SCCS External Experts: E. Benfenati, N. Cabaton, E. Corsini, Ch. Delmaar, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz.
Adopted on: 30 October 2025.
Adopted on: 30 October 2025.
Palavras-chave
SCCS Environmental Genotoxicity Regulation 1223/2009 Tea Tree Oil CAS/EC No. 68647-73-4 /285-377-1 Scientific Opinion Envrionmental Genotoxicity Genotoxicidade Ambiental
Contexto Educativo
Citação
Editora
European Commission, Directorate‑General for Health and Food Safety (DG SANTE)