Australia Releases Details of Cosmetic Regulation Reform: NICNAS will be replaced

Takehome:

The current National Industrial Chemicals Notification and Assessment Scheme (NICNAS), which is a statutory scheme to regulate a broad range of chemicals including cosmetics, will be replaced by Australian Industrial Chemical Introduction Scheme (AICIS) from 1 July 2018.
New chemicals (cosmetic ingredients) not on Inventory list will be subject to risk assessment before safety assessment. New chemicals are divided into 5 categories based on estimated hazardous risk.

In Australia, cosmetics are classified as industrial chemicals, and regulated by National Industrial Chemicals Notification and Assessment Scheme.(See current Australia cosmetic regulation: CL ) Recently, Chemlinked received information of NICNAS reform which will be outlined below:

New legislation will establish the framework for a new scheme to be known as the Australian Industrial Chemicals Introduction Scheme (AICIS). This scheme will replace the existing National Industrial Chemical Notification and Assessment Scheme (NICNAS) and enable the Commonwealth to continue to regulate the introduction of industrial chemicals (including cosmetics) in Australia from 1 July 2018. The new framework AICIS will:

Initiate an evaluation of any industrial chemical or group of chemicals, tailored to address issues of concern;
Have broader monitoring and compliance powers, which will deliver an appropriate balance between the reduction in pre-market assessment of lower risk chemical introductions, and increased post-market monitoring;

Specifically, key features of the new framework include:

1. Any person who introduces an industrial chemical in Australia (either by importing or manufacturing the chemical) would still need to be registered with AICIS;

2. AICIS would establish and maintain the Australian Inventory of Industrial Chemicals (AIIC, the Inventory), which will replace the Australian Inventory of Chemical Substances (AICS) and will list "existing" industrial chemicals that any registered person may introduce (ingredients used in cosmetics should be listed on AIIC, the Inventory);

3. A registered person who wishes to introduce a 'new' industrial chemical (a chemical that is not listed on the Inventory), or to introduce an 'existing' industrial chemical outside the terms of the inventory listing, would determine the risk of the chemical by considering the chemical's hazard (the intrinsic properties of the chemical that may cause harm to human health or the environment) and the degree to which people or the environment may be exposed to the chemical as a result of its introduction;

4. Registered introducers would be expected to know the way in which a chemical is expected to be used in Australia (and its likely exposure to people and the environment), and to hold (or have timely access to) information on its intrinsic hazards. Introducers are likely to obtain this information from international sources, and must have the legal right to use any intellectual property associated with this information;

5. The legislation would establish five categories of new (unlisted) industrial chemical introductions. Three of these categories will be determined based on hazard and exposure criteria: Exempted, Reported and Assessed. The other two categories, Commercial Evaluation Authorization and Exceptional Circumstances Authorization, will apply to specific circumscribed introduction scenarios.

Exempted chemical introductions would be categorized as very low risk based on the chemical's lack of hazard and/or its very low exposure to people and the environment. A registered introducer could import or manufacture an industrial chemical under the Exempted introduction category without any other interaction with AICIS prior to introduction. However, they must maintain records as to the basis on which the introduction was categorized as Exempted, and (as part of annual registration) declare to AICIS that they are an introducer under this category.
Reported chemical introductions would be categorized as low risk based on their hazard and/or exposure, or a trusted international regulator (as determined by Government) has assessed the chemical for the same use and similar introduction volumes and concentrations. A registered introducer would be required to: report this chemical introduction to AICIS prior to import or manufacture, maintain records as to the basis on which the introduction was categorized as Reported, and (as part of annual registration) submit an annual declaration to confirm that the introduction continues to meet the Reported criteria.
Assessed chemical introductions would be categorized as medium to high risk chemical introductions based on the chemical's hazard and/or exposure. A registered introducer must submit information to AICIS for a risk assessment and must not introduce the chemical until an assessment certificate has been granted. The assessment will focus on the human health and/or environment concerns identified through the categorization. To increase transparency, an assessment statement (protecting confidential business information (CBI) where necessary) will be published when the certificate is granted and linked to the Inventory listing at the expiry of the certificate period (or earlier on request).