Animal testing and cosmetics

Data requirements and animal testing for new cosmetic ingredients

Cosmetic ingredients are subject to the requirements of the Industrial Chemicals (Notification and Assessment) Act 1989 (the ICNA Act), and are regulated under NICNAS.

NICNAS does not require each cosmetic product to be tested, nor does it require that any of the ingredients that are already in use in Australia and listed on the Australian Inventory of Chemical Substances (AICS) be tested.

However, if a new chemical ingredient is proposed to be used in a cosmetic product, it must be notified to NICNAS and (unless exempt from assessment) assessed for its human health and environmental impacts.

The extent of scientific information required for assessment depends on the category under which the chemical is notified to NICNAS. The ICNA Act outlines matters to be dealt with in notification statements for individual notification categories.

In general, the information required to be submitted for NICNAS to assess the risks of a new cosmetic ingredient depends on the volume or concentration proposed for its use in Australia, and the hazardous nature of the chemical (factors that determine the estimated risk from the chemical's use).

A full suite of health effects information is only required for those chemicals considered to warrant more in-depth assessment (e.g. hazardous chemicals or those introduced in high volumes and/or at high concentrations). To ensure safety standards are not compromised, the quality of data submitted to NICNAS is evaluated with reference to the Organisation for Economic Co-operation and Development (OECD) Test Guidelines, which have wide international regulatory acceptance.

For most human health toxicology endpoints, animal tests are considered to be the most reliable form of evidence because they observe the overall effects of a chemical on a living subject. Animal tests therefore provide the most reliable means of confidently characterising the risks of a chemical to human health, and ensuring that any risk management recommendations are necessary and sufficient to manage those risks. For some toxicology endpoints, validated alternative methods (that do not require the use of animals) are available and accepted by NICNAS in place of animal tests to characterise the health risks posed by a chemical (such as for skin and eye irritation). Further guidance is available on data requirements for new chemicals.

Under the ICNA Act, NICNAS is able to waive particular information requirements where the introducer can provide alternative data to enable an adequate risk assessment to be conducted. This is known as a 'Variation to the Scheduled Data Requirements' and requires a formal application to be made to NICNAS at the time of submitting the notification. The alternative data could be from non-animal tests (in vitro tests) or from animal testing which has previously been conducted on similar chemicals (analogue data). To ensure safety standards are not compromised, it is important that data from analogues or non-animal tests can be demonstrated to give accurate and reliable information, through a data validation process.

Where animal data (or suitable data from validated alternative sources) are not available, NICNAS utilises all available data in a 'weight of evidence' (WoE) approach to estimate the likely health risks of a chemical. However, the inherent uncertainty arising from the lack of data from validated tests means that risk management recommendations made by NICNAS need to account for that uncertainty. A precautionary approach to the risk assessment, including recommendations for risk controls to mitigate a risk that cannot be ruled out on available data (as distinct from managing a known and quantified risk), is taken in such situations.

For many health effects, non-animal test methods have either not yet been developed (such as for systemic repeated dose toxicity), or are still in the process of evaluation and validation.

Extensive efforts are underway internationally to develop and validate non-animal test methods. Once validated, these are incorporated into internationally accepted OECD Test Guidelines and used by regulatory authorities, including NICNAS, to assess health impacts of chemicals. NICNAS is closely monitoring the progress of non-animal test methods and is evaluating them for use in safety assessments as validated methods become available.

Last update 15 May 2019