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

Mahima: Products are determined to be either “cosmetics” or “therapeutic goods” based on three factors—the primary intended use of the product; the ingredients used in the product; and the claims made about the product.

Products and their ingredients that are medicines or marketed with a claim of having therapeutic effects, such as skin-whitening products, primary sunscreens, complementary medicines, blood products, etc., are considered "therapeutic goods" and regulated by the Therapeutic Goods Administration (TGA).

Whereas products and their ingredients that are not medicines or marketed as products not having therapeutic effects are considered “cosmetics” and are regulated under the AICIS.

Mahima: AICIS regulates the ingredients in cosmetic products that are referred to as industrial chemicals, including those described as "natural," under the Industrial Chemicals Act 2019. In Australia, there is no single list of chemicals that are banned or restricted in products. However, there are other schemes that play an important role in regulating different links of a chemical's life cycle. E.g., the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP or Poisons Standard) is a record of decisions about the classification of medicines and chemicals used in consumer products, signifying the degree of risk and control recommended to be exercised over their availability to the public. In addition to these schemes, one must comply with relevant regulatory obligations associated with the category under which the chemical is introduced.

All cosmetic products must be labeled in accordance with the mandatory standard for cosmetic product labeling (Consumer Goods (Cosmetics) Information Standard 2020), in addition to other applicable requirements under the Australian Consumer Law (ACL). Further, any legal requirements pertaining to warning and other safety statements as listed in the Poisons Standard  must be complied with.

A cosmetic product is a substance designed to be used on any external part of the body or inside the mouth to change its odor or appearance, cleanse it, keep it in good condition or protect it. One must ensure that no therapeutic effects or actions are claimed for products being marketed as a cosmetic.

Mahima: Yes. Under the AICIS framework, anyone who imports or manufactures (introduces) industrial chemicals, or products releasing industrial chemicals into Australia, must register their business with the AICIS and categorize each chemical importation or manufacture (introduction) into one of the five introduction categories—Listed, Exempted, Reported, Assessed, and Commercial Evaluation Authorization. Under each category, there are certain regulatory obligations that must be complied with. E.g., submission of pre-introduction reports, post-introduction declarations, etc. Further, an annual declaration needs to be submitted for all industrial chemicals introduced in the previous registration year (September 1—August 31 the following year).