Australia regulates industrial chemicals at the federal, state, and local levels. Recent reforms to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) aim to streamline risk assessment processes and increase utilization of international data sharing. NICNAS has already successfully shared assessment materials and engaged in data sharing initiatives through bilateral and multilateral partnerships. Going forward, NICNAS intends to continue publishing publicly available information, aligning regulatory approaches, and promoting greater harmonization of chemical assessment globally to further enhance the efficiency of regulation and availability of safety information.

1. An Australian perspective
on the smarter use of available data
Panel 3: Global Data Sharing
Helsinki Chemicals Forum 2016
Dr Brian Richards
Executive Director, Office of Chemical Safety, Department of Health
Director, National Industrial Chemicals Notification and Assessment Scheme (NICNAS)

2. Lawmaking and regulation in Australia
May 2016 1
Australia has three levels of
government:
• Local
• State
• Federal
Each level of government
has its own responsibilities,
although in some cases
these responsibilities are
shared.

3. Industrial chemical regulation in Australia
All three levels of government regulate industrial chemicals.
1. NICNAS regulates the introduction of chemicals at the
Federal level.
2. States and territories regulate chemical use.
3. Local government regulates disposal.
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4. Rethinking the regulatory framework
2006 The Council of Australian Governments (COAG)
identified chemicals and plastics as a
‘regulatory hotspot’
2008 Australia’s Productivity Commission identified
a number of reform initiatives to improve the
efficiency and effectiveness of the chemical
management framework in Australia
2012-14 Review of NICNAS recommended reforms to the
regulation of industrial chemicals in Australia
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5. NICNAS Reforms
NICNAS Reforms were announced in May 2015 (to be
implemented by September 2018), and include:
• rebalancing pre- and post-market regulatory requirements
to match the indicative risk profile of a new chemical
• streamlining risk assessment processes for new
and existing industrial chemicals (including
‘International pathways’)
• greater utilisation of international assessment materials
• more appropriate compliance tools.
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6. NICNAS needs global data sharing
The new framework will:
• Use internationally available data for hazard categorisation
• Adopt common software for data management (i.e. IUCLID)
• Harmonise data requirements with comparable regulators,
international standards and risk assessment materials where
possible
• Enable ‘international pathways’ to facilitate a lighter regulatory
touch
• Improve public access to assessment data by linking inventory
entry to the assessment report about the chemical.
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7. NICNAS information sharing to date
NICNAS already shares assessment materials through:
• Bilateral engagement, primarily with Canada, US, Europe and
New Zealand
• Multilateral engagement through OECD (e.g. TFHA,CHNC,
WPMN), UNEP, WHO programs
• Assessment activities, informed by international public
databases, standards and guidelines, regulations and alerts (e.g.
IMAP Framework)
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8. Future global data sharing
NICNAS will continue to:
• publish information in the public interest
• engage with bilateral and multilateral partners
• encourage data sharing (such as QSAR results) with
international governments (with appropriate protection of
commercially confidential information)
• promote harmonisation by aligning regulatory approaches and
standardising criteria (eg polymers), volume thresholds, etc.
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9. IMAP - a NICNAS data sharing success story
• IMAP has assessed over 3300 existing chemicals since 2012
• IMAP assessments have resulted in significant risk management
action in Australia
• NICNAS engagement with other regulators and industry bodies
on chemical assessments has improved assessment outcomes
• NICNAS has enhanced the availability of chemicals safety
information by publishing its assessment outcomes for use by
other stakeholders, including other regulators
• NICNAS’s experience with IMAP is shared with other regulators
to inform future directions
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10. Why is IMAP successful?
• Builds on frameworks developed internationally, taking into
account lessons learned and evolving data sources i.e. CMP, REACH
• Makes use of the range of data generated or gathered by many
national and international agencies
• Applies available data in the Australian context to increase risk
assessment efficiency, reduce duplication of effort, and inform risk
management decisions
• Develops data management tools, QSAR strategies and
assessment methodologies based on international best practice
• Aligns human health and environmental scientific criteria with
hazard classification frameworks in use internationally
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11. Should we aim for a global chemical dossier?
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• Already established in pharmaceutical
and IP sectors
• Possible where there is global
agreement on desirable minimum
data set (even if not mandatory)
• Facilitates further harmonisation
between regulators, while recognising
jurisdictional differences
• IUCLID enhancements that suit different
jurisdictions may make this easier

12. Summary
• Australia has already obtained significant benefit from
global data sharing
• We look forward to participating in ongoing efforts
to achieve greater global harmonisation of chemical
regulation
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