The major risk identified from the use of consumer products containing tea tree oil comes from the sensitising potential of concentrated (greater than 2 per cent.) solutions, particularly if the product has been exposed to oxygen, sunlight or higher temperatures. However, the European Scientific Committee on consumer products has advised that the data available are currently insufficient to assess the potential risk of a range of toxic effects.
The Committee requested that a complete package of data be provided in order for them to give an opinion on the potential risks. The conclusions will then be used to amend the cosmetics directive in order to make any restrictions on the use of tea tree oil in cosmetic products legally enforceable. In the meantime, industry has advised that tea tree oil should only be used in cosmetic products at concentrations at or below 1 per cent., and should be formulated and packaged in a way to minimise degradation.
15 medicinal products containing tea tree oil, licensed under medicines legislation, are available in the United Kingdom. There may be other medicines that contain tea tree oil, which currently reach the market as unlicensed herbal remedies. These will potentially qualify to be registered under Directive 2004/24/EC when it is implemented on
As with all medicines, the safety of medicinal products containing tea tree oil is closely monitored by the Medicines and Healthcare products Regulatory Agency. There are no safety concerns specific to the medicinal use of tea tree oil but all effective treatments may cause unwanted side effects in some patients, which may be the result of individual sensitivity to the medicine concerned.