Key outcomes of Consultation Paper 1
In summary, stakeholders generally supported the direction of the reforms and the move to a more proportionate risk-based approach relative to the current approach.
The main areas of support for the reforms related to:
- the categorisation of new chemicals
- the regulatory treatment of Class 1 (now called “Exempted”—see Part D for details) chemicals
- the proposed approach to Class 2 (now called “Reported”) chemicals (for example, advice to NICNAS only, rather than pre-market assessment)
- the overall process proposed to be adopted for assessment of Class 3 (now called “Assessed”) chemicals (for example, focusing the assessment effort on the areas of greatest risk)
- the use of exposure and hazard bands to determine risk, and
- the use of anticipated release volumes for environmental exposure (rather than introduction volumes).
The main areas of concern regarding the initial reform proposals related to:
- the complexity of the risk matrices
- the capacity of industry to be able to self-categorise against the chemical classes
- the risk that industry would inappropriately use Class 1 (Exempted) and introduce chemicals without adequate oversight by NICNAS (i.e. should be reported to or assessed by NICNAS)
- the lack of public disclosure of Class 2 (Reported) chemicals
- concern about the regulatory treatment of chemicals for which there is an absence of data for a particular hazard band, and
- the proposed transition period of 6 months for new chemicals under exemptions, permits or certificates at the commencement of the reforms not being a sufficient period.
The main areas in which there was no consensus and disparate views amongst stakeholders related to use of international assessments. For example:
- there was no agreement on which international assessments should be relied on for allowing Class 3 (Assessed) chemicals to be introduced under Class 2 (Reported) based on an assessment by a trusted overseas regulator; some suggested that the international assessments proposed by NICNAS were appropriate and others suggested various additions to the list of regulatory authorities that should be accepted
- stakeholders questioned what would happen if two regulators had differing regulatory assessment outcomes with respect to the same chemical
- different sectors had differing views about which international approach should be adopted
- some stakeholders felt all chemicals in use approved by comparable international agencies, or available on overseas markets after industry self-assessment, should automatically be approved for use in Australia, while others strongly opposed this position (some argued that any chemical banned in a comparable country should be automatically banned in Australia)
- some stakeholders thought that any chemical assessed by a comparable international agency should be approved for use in Australia, while others thought that this should only apply with respect to certain types of chemicals (for example, chemicals in formulated cosmetics)
- stakeholders described differing interpretations of how international regulatory approaches worked in practice, and
- many stakeholders sought adoption of the more favourable aspects of international regulatory systems, but rejection of the less favourable aspects (i.e. only partial harmonisation).
The main areas in which stakeholders sought further information were:
- data requirements for new chemicals (addressed in this Consultation Paper)
- NICNAS’s proposed approach to audit, monitoring and compliance (to be addressed in Consultation Paper 3), and
- NICNAS’s approach to the acceptance of international approvals, assessments and other information (addressed in this Consultation Paper).
In terms of the consultation process relating to the reforms, stakeholders appreciated the staged consultation process (including multiple opportunities to comment) and encouraged NICNAS to make greater efforts to engage non-industry stakeholders, particularly consumer, public health, worker and environmental organisations.
To better engage with all stakeholders, NICNAS intends to expand on the existing consultation opportunities outlined in the NICNAS Reform Implementation Plan, by:
- conducting dedicated community workshops in Sydney, Melbourne and other capital cities based on demand
- using a range of media to announce the release of consultation papers and opportunities for comment, and
- direct mailing peak consumer, environmental, health and worker groups.
This additional engagement will ensure that organisations that represent consumers, public health, workers and environmental concerns have every opportunity to be part of the reforms process through the release of Consultation Papers, stakeholder forums and their representatives on the NICNAS Strategic Consultative Committee.
Last update 17 February 2016