The Permissible Ingredient Determination (No. 4 of 2019) has been published on the Federal Register of Legislation and commences 1st January 2020. It replaces the Therapeutic Goods (Permissible Ingredients) Determination ( No.3) 2019.
Key changes to note include;
Products containing Andrographis
Andrographis paniculata has new warnings statements required on labels of existing listings by 2nd May 2020 (at release for supply) and of NEW listings by 1st January 2020.
These warnings have been introduced due to the increased pharmacovigliance reports of episodes of anaphylaxixs and allergic reactions to this ingredient.
The new warning statement is:
‘Andrographis may cause allergic reactions in some people. If you have a severe reaction (such as anaphylaxis) stop use and seek immediate medical attention’ (or words to that effect).’.
To read more about this matter, please visit the TGA website.
Products containing menthol and methyl salicylate
There has been a relaxation of restrictions to ingredients containing menthol and methyl salicylate, which are in effect from 1st January 2020.
The below list of affected menthol containing ingredients will require the following warning if the topical listed medicines contain concentrations of menthol that are 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’.
If the product contains less than 1% menthol (such as in topical PIs), then these warnings no longer are required. All other requirements for menthol remain applicable.
- 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
The below list of affected methyl salicylate containing ingredients will require the following warning if the topical listed medicines contain concentrations of methyl salicylate that are greater than 1%;
‘(IRRIT) ‘If irritation develops, discontinue use’
If the product contains less than 1% methyl salicylates, then these warnings no longer are required. All other requirements for methyl salicylate remain applicable.
- Betula lenta
- Betula nigra
- Betula pendula
- birch leaf dry
- Filipendula ulmaria
- Gaultheria procumbens
- meadowsweet herb dry
- methyl salicylate
- Nyctanthes arbor-tristis
- wintergreen oil
The TGA have released the outcomes of ‘low-negligible risk’ changes however, these will be legislated in a new version of the Determination in March 2020, with a further 12 month transition period. These changes include amendments to the requirements to the following ingredients; Vitex agnus-castus, Withania somnifera, Boron, Isphagula spp, Plantago spp and Psyllium husk, Cymbopopon spp and Malus pumila.
Further changes to the ingredient Coumarin (in topical preparations) will be made in the March 2020 updates. To read more about this issue please visit the TGA website here.
We will be communicating greater detail on the above ingredients closer to the release of the updated determination in March next year.