Australia Clarifies Record-keeping Requirements for Introductions under NICNAS Exemptions

The previous NICNAS stipulated that cosmetics introduced into Australia can be exempted from notification in the following circumstances, even if the product contains new chemicals not listed on the Australian Inventory of Chemical Substances (AICS).

Cosmetic use not exceeding 100kg per year;
Cosmetic use at a concentration of 1% or less;
Non-cosmetic use not exceeding 100kg per year;
Used for research, development, or analysis.

On July 1, 2020, NICNAS was replaced by a new regulatory scheme known as the Australian Industrial Chemicals Introduction Scheme (AICIS). Under the transitional arrangements of Australis’s new scheme, these introductions will still be allowed until August 31, 2022 ^[1]. After this date, re-categorization under the current AICIS will be required.

On December 17, 2020, Australia AICIS issued a notice clarifying the enterprise obligations for chemicals introduced under NICNAS exemptions after the grace period expires, to ensure continued compliance with the new scheme ^[2].

As per the notice, importers must submit an annual declaration at the end of each AICIS registration year and archive certain records that are sufficient to prove the introduction meets the exemption criteria of NICNAS and were compliant with the legislation for official inspection. Notably, the records shall be kept for 5 years, even after the stop of chemical introduction, and they shall be provided for review within 20 working days from the date of receiving the officials’ request.

The table below are the specific records required for cosmetics introduced under NICNAS exemptions after the transition period ends. The parts highlighted in red indicates the difference in the necessary documents for these two exemption types.

Cosmetic use not exceeding 100kg per year

Cosmetic use at a concentration of 1% or less

A record of the ingredient identity;
A record indicating that the ingredient is not a nanomaterial and not prohibited or restricted for use in cosmetics in the European Union under Council Directive 76/768/EEC or in the United States under the Food and Drugs Cosmetics Act 1938, such as information from the supplier;
Records proving the ingredient has an end-use in cosmetics and is not used in those cosmetics as a preservative, coloring agent, or UV filter, such as the SDS, product labels, or technical information sheets;
Records showing that the ingredient does not pose an unreasonable risk to occupational health and safety, public health, and the environment.
Records proving the total volume of the ingredient introduced during our registration year, such as the shipping documents;
If the ingredient is present in cosmetics at a concentration of ≥1%, records indicating that it will be safe for use by potentially high-risk groups - including infants, the elderly, and atopic persons - consistent with the anticipated pattern of consumer exposure.

A record of the ingredient identity;
A record indicating that the ingredient is not a nanomaterial and not prohibited or restricted for use in cosmetics in the European Union under Council Directive 76/768/EEC or in the United States under the Food and Drugs Cosmetics Act 1938, such as information from the supplier;
Records proving the ingredient has an end-use in cosmetics and is not used in those cosmetics as a preservative, coloring agent, or UV filter, such as the SDS, product labels, or technical information sheets;
Records showing that the ingredient does not pose an unreasonable risk to occupational health and safety, public health, and the environment.
Records proving the concentration of the ingredient in cosmetics is ≤ 1%, such as information from the supplier;
Records proving the ingredient is not hazardous. For example, the records must demonstrate that the ingredient is not a hazardous chemical; is not a dangerous good; has very low toxicity to fish, aquatic invertebrates, and algae (LC50 or EC50 ≥100 mg/L); and is readily biodegradable. The records must also show the ingredient has either a molecular weight or NAMW >1000g/mol, OR has a solubility in water > 1mg/L; OR dissolves in water without dissociation or association and is not surface-active, with a partition coefficient (n-octanol/water at 20°C, log Pow) ≤3.