On 6 June, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued scientific opinion(SCCS/1681/25) on Tea Tree Oil (CAS/EC No. 68647-73-4 /285-377-1). The deadline for comments is set for 18 August 2025.
Scientific Opinion on Tea Tree Oil
The SCCS concludes the following:
1. The SCCS considers the use of Tea Tree Oil (TTO) as an anti-seborrheic and anti-microbial agent safe 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, as well as the aggregated exposure from cosmetics 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 intended final cosmetic products.
- the use of TTO in the intended dermally applied cosmetic products, and not in aerosolised or sprayable products that may give rise to inhalation exposure of the consumer.
2. 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 SCCS mandate does not address environmental aspects. Therefore, this assessment has not covered the safety of TTO for the environment.
Regulatory Requirements Interpretation of Tea Tree Oil (TTO)
The Global Cosmetic Ingredient Regulatory Database-Global CosIng, an upgraded version of China CosIng independently developed by CIRS Group indicates that Tea Tree Oil (CAS No. 68647-73-4) is included in the following key lists globally.
In China, it has been included in the Inventory of Existing Cosmetic Ingredients in China (IECIC) (I) and the Usage Information of Selected Ingredients Included in the International Authoritative Cosmetic Safety Assessment Data Index. More details could be found in the following figure.
About CIRS
The CIRS cosmetic team is dedicated to ensuring that cosmetic products meet stringent global regulatory standards. It can provide one-stop services covering the whole life-cycle of a personal care product, which includes cosmetic ingredient development, physical/chemical tests, toxicological tests (in vivo & in vitro), efficacy studies (in vivo & in vitro), ingredient registration, and product registration.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
Further Information
Contact Us
Quick Navigation