Chemicals Regulation – Global Challenges
Challenges and Opportunities in Australia
Marion Healy
Director
NICNAS
Challenges and
Opportunities
 Existing chemicals - identifying and managing
chemicals of concern
 New chemicals - efficiency and effectiveness of
regulatory framework
 New Technologies – safe and sustainable use of
nanomaterials
1. Existing Chemicals:
Managing chemicals of concern
Major review of EC Program finalised in 2006
 Major complex assessments, resource intensive
 Small number of chemicals assessed, most chemicals on the
inventory not assessed
 Other countries/regions moving towards screening chemicals on
inventories
Aim of new initiative
 Identify chemicals of concern – systematic, comprehensive,
flexible and transparent
 require a paradigm shift
 Reviewed other approaches for applicability to Australia
Screening of inventory listed chemicals in use
Prioritise chemicals for further evaluation
1. Existing Chemicals:
Implications of Other Schemes
Issue
Implications
Data to underpin
prioritisation &
assessment
Generated for national, regional & international
schemes. How to reduce duplication of effort?
Which chemicals are
in use
Appears to differ across regions and time. Little
Australian data available
Similarity of listed
chemicals to other
inventories
Which chemicals are
hazardous
Significant overlap (up to 60%), BUT > 5,000
Australia only chemicals. Similar distributions
of different types of chemicals
Many chemicals – no public information.
Predictive modelling offers options.
Sharing information
Balancing confidentiality, reduced duplication
2. New Chemicals: More Efficient
Regulatory Frameworks
Low regulatory concern chemicals
 Fast tracked introduction of low risk and/or previously assessed
chemicals
safer chemicals
 Significantly expanded options to introduce safer chemicals
 Evaluation indicates successful strategy, although limited
uptake. Impact on safety flexibility, innovation and cost.
Multi and bi lateral cooperative activities
 Achieve efficiencies in assessing/ managing chemicals;
enhance ability to protect human health and the environment
 Bilateral –
 3 agreements in place
 Range from information exchange to work sharing
 Multilateral –
 Formal work share activities of OECD and WHO;
 Treaty commitments
2. New Chemicals:
Impact of Initiatives
Issue
Implications
Balance of
Balance facilitating innovation while
requirements for new protecting human health and the environment?
and existing chems
Should hurdles for new and existing chemicals
be the same?
Sharing assessment Multilateral organisations promote
approaches –
harmonisation but also innovative approaches.
methodologies, tools Opportunities to exploit?
Sharing assessments Bilateral approaches effective; confidence
- bilateral
building and bench marking.
Sharing assessments Progress is slower – reflects differences in
- multilateral
national legislative and expectations. How to
overcome?
3. Regulatory Principles
for New Technologies
REVIEW EXISTING FRAMEWORK
 If appropriate, utilise existing framework with suitable
procedural or regulatory changes.
 Consider if a new system for regulation is required.
 Conduct and review with transparency and inclusive processes.
MAKE USE OF BEST SCIENTIFIC EVIDENCE
 Ability to review decisions as new evidence becomes available.
TAKE MEASURES TO PROTECT HEALTH &
ENVIRONMENT
 When scientific evidence is insufficient to support safety, adopt
measure to protect human health, safety and the environment
 Risk should be no greater than risk from conventional chemicals
 Address risk pre market
 Support industry innovation with appropriate regulatory
oversight.
3. New Technologies:
Nanomaterials
Issue
Implications
Safety of
nanomaterials
Is there sufficient information to determine
safety? Appears to be significant uncertainty.
Regulatory
framework
Are modifications to our current framework
necessary? Probably.
Community
concerns
Will these concerns derail use of nanomaterials?
Can regulation allay concerns and promote
innovation? An objective!
Are there opportunities for international
harmonisation of assessments and regulatory
approaches? Yes.
International
harmonisation
Challenges and
Opportunities
 Initiatives underway to:
 identify and manage existing chemicals of concern
 improve efficiency and effectiveness of new chemical
processes
 facilitate the safe and sustainable use of nanomaterials
 Support robust assessments that are risk based and ‘fit for
purpose’
 Opportunities for greater levels of cooperation both bi- and
multi- laterally - information generated/collated, assessment and
regulatory approaches, work share arrangements
 Made significant progress and optimistic about future progress