Something You May Have Missed…
Tea tree oil, a popular ingredient in cosmetics, has been classified as a reproductive toxin by the European Chemicals Agency Risk Assessment Committee (ECHA RAC).
This classification, made in December 2023 as Category 1B (H360 May damage fertility or the unborn child), suggests that tea tree oil may soon be banned from the European cosmetics market.
The oil, which is derived from the Melaleuca tree (native to Australia) is famous for its antiseptic properties and can be found in shower gels, toothpastes, mouthwash and face cleansers, to cure skin complaints, to treat cuts and burns, and as an insect and lice repellent.
If a complete ban on cosmetics containing tea tree oil is implemented without exceptions, it will significantly impact all brands and manufacturers selling such products in the EU. Affected products will need to be removed from the market or reformulated to exclude tea tree oil.
Health Fears
Studies found that when rats ingested medium to high doses of tea tree oil, it had a negative impact on the male reproductive organs.
Warnings also came from the US after it was discovered that boys have been cautioned against using hair products containing tea tree oil, following reports of three boys developing breasts. US researchers suggest that tea tree oils might have hormone-like effects, causing gynaecomastia (breast growth) and indicated that frequent use of such oils could interfere with hormonal function.
Furthermore, it has been found that tea tree oil in cosmetics and creams might increase the risk of acquiring ‘superbug’ infections in hospitals – low-level exposure to the oil made bacteria like MRSA, E. coli, and salmonella more resistant to antibiotics.
Exemption Protocol
In EU Classification, Labelling and Packaging (CLP) regulations, substances classified as CMRs (carcinogenic, mutagenic, and reprotoxic), including those in Category 1B (H360), are prohibited for use in EU cosmetics unless an exemption is granted. Industry members can receive an exemption by demonstrating safe use according to specific criteria outlined in Article 15 of the EU Cosmetics Regulation (EC) 1223/2009.
Suppliers of tea tree oil can submit a safety dossier to the EU Scientific Committee on Consumer Safety (SCCS) to apply for this exemption. However, there is no certainty that the ingredient will be defended, and it is highly likely that tea tree oil will be banned in cosmetics in the EU and Northern Ireland, pending the publication of final legislation.
If confirmed, this change will be published as an Adaptation to Technical and Scientific Progress (ATP) to CLP, followed by the addition of tea tree oil to Annex II (prohibited substances) of the EU cosmetics regulation in the next CMR omnibus. Cosmetics already on the market that contain tea tree oil could continue to be sold until the new CMR omnibus takes effect, after which remaining stock would have to be removed from the market.
Implications for Other Markets
A ban would be limited to cosmetic products within the EU. However, household products within the EU would also be affected – limited to below 0.3% in the final product.
Since the UK operates under a different chemical and cosmetics regulatory framework than the EU, a potential ban on tea tree oil will not apply to cosmetics sold in Great Britain. However, this could change if UK cosmetics regulators decide to follow the EU in reclassifying tea tree oil as a CMR substance in the future.
The Australian Tea Tree Industry Association (ATTIA) who challenged the new classification claimed that the tests on rats were flawed as the human liver can metabolise and break down compounds such as terpenes, while rats do not. They also warned that this ban will likely have an effect on other essential oils.
ECHA Links
https://echa.europa.eu/-/highlights-from-november-2023-rac-and-seac-meeting
https://echa.europa.eu/registry-of-clh-intentions-until-outcome/-/dislist/details/0b0236e18571231a
Hibiscus Plc has been providing labelling solutions for the chemical and hazardous goods industries for over 40 years.
If you have any questions regarding the new minimum font sizes for labels, don’t hesitate to contact us.
Find out how we can improve your hazard communication compliance – Call us today: 0113 242 4272
