Azelaic acid is such an amazing multifunctional ingredient in skincare formulations. It offers a safe, stable, and versatile option for formulators. Its multi-functional properties have made it an essential ingredient for addressing various skin concerns, especially in gentle and effective formulations targeting sensitive and acne-prone skin.
Some current products on the market that use Azelaic Acid
NATURIUM – Azelaic Topical Acid 10%
- Claims: help improve the appearance of skin tone, for brighter-looking skin.
- Active: Azelaic Acid Derivative – Potassium Azeloyl Diglycinate
- More Info: https://naturium.com.au/products/azelaic-topical-acid-10
EGO – Azclear Action Medicated Lotion
- Claims: attacks pimples by fighting bacteria and unblocking the oil ducts. The Lotion acts to reduce redness and dry up pimples.
- Active: – Azelaic Acid 20% (w/w)
- More Info: https://www.azclearskin.com/?brandreferrer=egopharm
Dermal Therapy – Acne Spot Cream
- Claims: Effectively reduces breakouts
- Active: – Azelaic Acid Derivative – Potassium Azeloyl Diglycinate
- More info: https://dermaltherapy.com.au/area/face-lip/?_areas=face-lip&_conditions=acne
The Regulations
It is important to note that this ingredient is SCHEDULED here in Australia. Azelaic acid is listed in the Poisons Standard—the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) in Schedules 2 and 4.
Schedule 2 chemicals are described as ‘Substances, the safe use of which may require advice from a pharmacist and which should be available from a pharmacy or, where a pharmacy service is not available, from a licensed person.’ Schedule 2 chemicals are labelled with ‘Pharmacy Medicine’.
Schedule 4 chemicals are described as ‘Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription.’ Schedule 4 chemicals are labelled with ‘Prescription Only Medicine’ or ‘Prescription Animal Remedy’ (SUSMP 2021).
Currently, the Therapeutic Goods Administration (TGA) has addressed the scheduling for Azelaic Acid and its use, particularly for cosmetic and therapeutic applications, and these changes are effective 1 October 2024.
It has a NEW ENTRY, Schedule 5, which refers to substances that pose low to moderate risk of harm to human health and safety if not handled properly. These substances require cautionary labelling and packaging to ensure that the risks are mitigated, but they are generally considered safe when used correctly under specified conditions.
As of 1st October, any azelaic acid product, including dermal cosmetic or therapeutic goods, would need to have “avoid contact with skin” on the label. These include industrial preparations and cosmetic preparations containing no more than 10% azelaic acid.
Azelaic acid has also been added to Appendix E and F of the Poison Standard when the TGA added the new entry to Schedule 5.
The TGA is maintaining tight controls due to concerns about eye and skin irritation and ensuring that any products sold outside pharmacies are labelled appropriately for safety.
This scheduling is part of a wider approach to ensure that products with potential health risks are appropriately regulated.
Click here to read the final decision –
