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Changes to the label warning statement requirements for menthol & methyl salicylate
The TGA will be amending the requirements for menthol and methyl salicylate in the Therapeutic Goods (Permissible Ingredients) Determination ('the Determination'). The amendments will mean that some of the existing label warning statements will not be required when these ingredients are present at very low amounts such as when included in topical proprietary ingredient (PI) formulations.
In 2017, the TGA reviewed the safety of menthol, methyl salicylate, and related ingredients in listed medicines. The TGA sent letters in early 2018 to affected sponsors and suppliers of proprietary ingredients regarding the proposed changes to the requirements for menthol and methyl salicylate. At the time concerns were not raised regarding the proposed restrictions for these ingredients when present in PIs used in topical medicines.
In 2018 the TGA made changes to the requirements for menthol and methyl salicylate following evaluation of the available safety and toxicology data for both ingredients. As a result, a number of warning statements were required to be included on the labels for both menthol and methyl salicylate. The compliance transition period for these changes expires on 1 January 2020.
In October 2019 the TGA was contacted by sponsors who sought an exemption from the warning statement requirements for menthol and methyl salicylate when included in low concentrations in topical PIs. Sponsors also provided the TGA with safety information and a justification supporting the reconsideration of the warning statements.
New requirements for menthol and methyl salicylate
After reviewing the previous safety evaluations and taking into account new information that has since become available, the TGA will amend the current requirements to be less restrictive for menthol, methyl salicylate and related ingredients as outlined below.
Menthol and ingredients containing menthol
The following warning statements will only be required on the label of topical listed medicines when the concentration of menthol in the medicine is greater than 1%:
- (IRRIT) 'If irritation develops, discontinue use' and
- (SKTEST) 'If you have sensitive skin, test this product on a small area of skin before applying it to a large area'
The changes to the requirements for menthol will be introduced for the following ingredients:
- Mentha aquatica
- Mentha arvensis
- Mentha arvensis leaf oil
- Mentha arvensis oil
- Mentha haplocalyx
- Mentha pulegium
- Mentha spicata
- Mentha x cardiaca
- Mentha x piperita
- mint oil dementholised
- peppermint american ext.
- peppermint leaf dry
- peppermint leaf powder
- peppermint oil
- peppermint oil terpeneless
- peppermint oil terpenes and terpenoids
- spearmint oil
- spearmint oil terpeneless
Methyl salicylate and ingredients containing methyl salicylate
The following warning statement will only be required on the label of topical listed medicines when the concentration of methyl salicylate is greater than 1%:
- (IRRIT) 'If irritation develops, discontinue use'
All other requirements and label warnings for the affected ingredients will remain the same as currently listed in the Determination. The transition periods for compliance with the amendments to both menthol and methyl salicylate will remain the same, as the above amendments are not introducing more restrictive requirement.
These changes will be implemented as soon as possible and a new Determination is expected to be in effect by the end of December 2019.
The changes to the requirements for methyl salicylate will be introduced the following ingredients:
- Betula lenta
- Betula nigra
- Betula pendula
- birch leaf dry
- Filipendula ulmaria
- Gaultheria procumbens
- meadowsweet herb dry
- methyl salicylate
- Nyctanthes arbor-tristis
- wintergreen oil
What sponsors need to do
The TGA recognise that there are commercial arrangements surrounding PIs. However, the TGA wishes to remind sponsors to maintain an awareness that PIs may contain ingredients that are subject to restrictions. Sponsors should communicate with PI suppliers to ensure their listed medicines remain compliant.