NEW AUSTRALIAN REGULATION AND PROHIBITION OF ANIMAL TESTING

In Australia, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) has been replaced in the beginning of July, 2020 by a new scheme known as Australian Industrial Chemicals Introduction Scheme (AICIS), as established by the Industrial Chemicals Act 2019 (IC Act 2019). AICIS is now the entity responsible for regulating the manufacture and importation of industrial chemicals, and consequently regulating cosmetic products. Chemicals are regulated depending on their use and if it is not for a therapeutic, agricultural, veterinary or food use, it is considered an industrial chemical.

Under Australian law, ‘new animal test data’ is defined as “any data obtained from tests conducted on cephalopod or any live vertebrate animal (other than human being) on or after 1 July 2020”.

According to the IC Act 2019, safety of new cosmetic ingredients manufactured or imported into Australia cannot be demonstrated with animal testing information. This means that the current legislation bans the use of new animal test data to support the introduction into Australia of industrial chemicals used exclusively as cosmetic ingredients. There are also restrictions on using new animal test data for chemicals with multiple end uses (including in cosmetics). Cosmetics industry and the Department of Health are working together to develop a voluntary code of practice.

Ingredients and cosmetics that are already on the market will not be affected by this new legislation. For new cosmetic ingredients, instead of animal testing, legislation allows the use of alternative methods to support its introduction (and safety), like the ones validated by the Organization for Economic Co-operation and Development (OECD) or computer-based modelling. Existing animal test data of a similar chemical can also be useful in the introduction of new chemicals and is overviewed in the legislation as an alternative also.  

Limited exception criteria, consistent with the European Union’s Regulation, have been set up regarding when new animal test data can be used for chemicals with an end use in cosmetics. The following exceptions apply where the new animal test data:

• Shows that the chemical has a hazard characteristic and it conflicts with non-animal test data;
• Is the only information that can demonstrate whether or not the chemical has a particular environment hazard characteristic;
• Is from tests conducted on a different industrial chemical to the one that is being categorized or submitted an application for, and the company is not introducing that different chemical for an end use in cosmetics (read-across information from non-cosmetic chemicals);
• The introduction has multiple end uses (including cosmetics), other exception criteria are not met and there is no alternative to animal test data.

All things considered, with the new Australian legislation, the ban of animal testing will cover most cosmetics introduced in Australia. Non-animal testing should be always considered first, and new animal test data should be faced as a last resort. Australian legislation allows for a range of alternative data sources to be provided instead of animal test data.

References:

1. Australian Government, Department of Health – Australian Industrial Chemicals Introduction Scheme (AICIS) – website – https://www.industrialchemicals.gov.au/
2. Australian Government – Industrial Chemicals (Notification and Assessment) Act 1989 (ICNA Act)
3. Australian Government – Industrial Chemicals Act 2019
4. Australian Industrial Chemicals Introduction Scheme (AICIS) – Industrial Chemicals Categorisation Guidelines
5. Australian Industrial Chemicals Introduction Scheme (AICIS) – Industrial Chemicals Categorisation Guidelines – Final Draft, 2019
6. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products –