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Interview Vol. 7 | Australia Focus: Interpretation of AICIS and TGA Regulations for Cosmetics

On July 1, 2020, the Australian Industrial Chemicals Introduction Scheme (AICIS), established according to Industrial Chemicals Act 2019, officially replaced the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) as the new national regulator for the importation and manufacture of industrial chemicals in Australia. The new regulatory scheme also regulates the industrial chemicals for cosmetic use and supports cosmetic manufacturers in achieving easy import of new low-risk chemicals to the Australian market. In addition, Australia also has special regulations for cosmetic products with therapeutic effects, such as primary sunscreens, skin lightening products, etc. ChemLinked invited Ms. Mahima Gupta, regulatory affairs consultant from the leading global regulatory solutions and services company Freyr, to share her insights about Australia’s AICIS scheme, classification criteria of cosmetics and therapeutic goods, cosmetic compliance requirements, and market entry suggestions. More details of Australia’s AICIS and TGA regulations for cosmetics are available in ChemLinked’s webinar on November 16. Welcome to register for free.
Winnie: Can you give a brief introduction of Australia’s AICIS, as well as the regulatory framework and the competent authorities for cosmetics?

Mahima: AICIS, Australian Industrial Chemicals Introduction Scheme, replaced NICNAS on July 1, 2020. Under the Industrial Chemicals Act 2019, which is administered by the AICIS, ingredients used in personal care, skin care, make-up, and other cosmetic products are regulated as industrial chemicals. An importer or manufacturer of industrial chemicals is called an "introducer," and the activity of importation or manufacturing is called "introduction." Under the AICIS framework, if an introducer intends to introduce industrial chemicals or products releasing industrial chemicals into Australia, they must:

  • Register their business with the AICIS

  • Categorize their introductions into one of the five introduction categories

  • Submit declarations and reports

  • Keep records

  • Provide relevant information as and when requested by the AICIS

Winnie: Which products are subject to cosmetic compliance, and which are subject to TGA regulations?
Winnie: What are the AICIS compliance requirements for cosmetic products, such as formulation, label, and claims? Could you specify?
Winnie: The new Australian AICIS regulations have been implemented for more than a year. For cosmetic companies, are there any aspects they should pay attention to?

Webinar Recommendation

For more insights from Ms. Mahima on Australia’s AICIS and TGA regulations for cosmetics, welcome to join the ChemLinked webinar coming on November 16, 2021, which will cover cosmetic ingredient introduction details, enterprises’ regulatory obligations, mandatory labeling obligations, animal testing ban, therapeutic goods regulations, etc.


About the Expert


Mahima Gupta

Regulatory Affairs Consultant

With over three years of experience in cosmetics and personal care product regulations of the USA, Canada, and Australia, Ms. Gupta oversees the regulatory activities for successful product development, registration, and commercialization. Her expertise in aligning brands with regulatory requirements has helped Freyr establish long-term relationships with multiple clients.

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