Australia to Reform Cosmetic Overarching Regulation NICNAS

Australia is to reform their NICNAS (overarching regulation for cosmetic), aiming to reduce regulatory burden Registration and assessment will be simplified, which will benefit manufacturers/importers. Australia will reform its National Industry Chemicals Notification and Assessment Scheme...

Takehome:

Australia is to reform their NICNAS (statutory scheme to regulate cosmetic), aiming to reduce regulatory burden.
Registration and assessment will be simplified, which will benefit manufacturers / importers.

Australia will reform its National Industry Chemicals Notification and Assessment Scheme, the statutory scheme to regulate chemicals including cosmetics. The major changes affecting the cosmetics industry will be fully implemented by Sep.1st 2018; however some of the proposed changes are already effective since Sep.1st 2016.

To reduce regulatory burden and help Australia becomes more competitive, the reform involves:

rebalancing pre- and post-market regulatory requirements to match the risk profile of a new chemical;
streamlining the existing risk assessment process for new and existing chemicals;
greater utilization of international assessment criteria;
more appropriate compliance tools.

Officials predict that the changes will lower the costs of market entry and a large number of chemicals should be subject to significantly reduced costs. It is expected that the overall reduction in regulatory burden to industry per year will be $23 million;

For new chemicals, pre- and post-market regulatory controls will be rebalanced by applying a risk based framework to match assessment standards to the risk profile of individual chemicals:

Category	Form of treatment
Exempted	Automatic entry Will not require pre-entry notification or assessment, or post-market annual compliance declaration Required to keep records and may be audited for compliance Usage still subject to existing state and territory regulation
Reported (Low Risk)	Introduction allowed following self-assessment against criteria and pre-entry notification to NICNAS Will require pre-market notification to include trade name, chemical name, CAS number (where available), hazard classification and / or information, volume (to be introduced) and intended use Introducers will have to provide a yearly compliance declaration to NICNAS to confirm the category criteria NICNAS will annually audit (undertake risk screening and assessments as needed) a proportion of notifications to validate that they are compliant
Assessed (Medium to High Risk)	An assessment certificate will still be necessary before introduction Risk assessment will be conducted within a statutory period Certificate may include particulars of use (i.e. extent of the risk assessment undertaken) and conditions of use (such as annual volume, sites of use, time-limited certificate) If risks cannot be managed (either by conditions of introduction or imposition of risk management conditions by risk management agencies), a certificate may be refused A summary of the assessment will be published NICNAS will undertake post-market auditing to ensure compliance NICNAS may initiate a post-market assessment if a possible new risk