The Australian Government has decided to reform the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) to:
- make regulatory effort more proportionate to risk
- promote safer innovation by encouraging the introduction of lower risk chemicals
- continue to protect the Australian people (both workers and the public) and the environment from any harmful effects of industrial chemicals.
We have published 4 previous consultation papers over the past 2 years, and have received a considerable amount of feedback from stakeholders.
The consultation process has helped us develop advice for Government on the best way to implement the reforms. The result is the introduction of legislation to Parliament to establish a new scheme called the Australian Industrial Chemicals Introduction Scheme (AICIS).
The legislation is principles-based. It will establish a new legal framework for the regulation of industrial chemicals in Australia. Much of the technical detail supporting the new framework will be in delegated legislation. This will allow flexibility to adapt to scientific and regulatory developments.
Through Consultation Paper 5, we seek feedback on matters to go into the delegated legislation.
Mostly, these are technical matters. They relate in particular to the categorisation and assessment of unlisted chemical introductions. That is, the introduction of industrial chemicals not included on the Australian Inventory of Industrial Chemicals (the Inventory).
This paper is detailed because we wish to present the new scheme in a transparent way. Not all stakeholders will need to engage in the level of technical detail presented in this paper.
The technical matters in this paper (and the companion Supporting Material) take into account:
- the latest international developments in chemical risk assessment and regulatory science
- the need to implement a practicable scheme that is proportionate in the requirements it sets.
Figure 1 illustrates how the parts of this paper relate to the new scheme’s categorisation and assessment process.
Part 1 gives context about this consultation. It is a general overview of the NICNAS reforms, announced in May 2015 by the Australian Government.
Part 2 talks about consultation to date on the implementation of the reforms. It focuses on the development of the technical detail to be set out in the delegated legislation and guidance material. Our Response to feedback on technical details, which accompanies Consultation Paper 5, provides more detail about how we have used the feedback that we have received.
Part 3 describes the objective hazard and exposure criteria. These criteria will provide a structured and transparent approach to self-categorisation of industrial chemical introductions. The chemical categorisation outcomes (Exempted, Reported or Assessed) will allow risk-based regulation. Because of this, we will be able to focus our regulatory efforts on higher risk chemicals.
Part 4 describes the requirements for information that:
- an introducer must consider in categorising their chemical introduction
- we will need as part of an assessment certificate application.
Part 5 provides the detail of the hazard information required to categorise chemical introductions the right way for both human health and environmental risks. The level of hazard characterisation required will vary with the predicted level of exposure.
Part 6 describes additional information requirements. These will apply for a limited set of specified chemical introductions where minimum information requirements will not be enough to determine the indicative risk, and thus the appropriate introduction category.
Read more about the information requirements framework in our Supporting Material, which accompanies Consultation Paper 5. It includes guidance on the hazard information that will be sufficient for categorisation. It takes into account the latest scientific developments, including in vitro tests and in silico modelling and the more traditional toxicological data derived from tests using animals.
Part 7 is a proposal for the categorisation of industrial chemicals introduced at the nano-scale. It presents options for the properties of nano-scale chemicals that should be used as criteria to define the chemicals that require pre-introduction assessment.
Part 8 describes the criteria for the commercial evaluation authorisation pathway that will be prescribed in the delegated legislation. It will include the volume threshold and the circumstances related to public exposure. It also talks about the information requirements for this pathway.
Part 9 presents the details to be included in the delegated legislation to implement the national ban on the use of new animal test data for chemicals used exclusively as cosmetic ingredients.
Part 10 discusses other matters to be included in the delegated legislation including:
- prescribed bodies for consultation
- prescribed bodies for disclosure of confidential business information (CBI)
- definitions to be elaborated on in the delegated legislation (including article and industrial chemical)
- requirements for the annual compliance declaration.
We are seeking your feedback on the proposed implementation detail in this paper.
We will consider your feedback. After this, we will draft the delegated legislation. Consultation on the delegated legislation should occur in the second half of 2017.
Figure 1 - Relationship between sections of this consultation paper and the categorisation process
Last update 29 July 2018