Chemicals Regulation – Global Challenges Challenges and Opportunities in Australia

1. Chemicals Regulation – Global ChallengesChallenges and Opportunities in Australia Marion Healy Director NICNAS

2. 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

3. 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

4. 1. Existing Chemicals: Implications of Other Schemes

5. 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

6. 2. New Chemicals: Impact of Initiatives

7. 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.

8. 3. New Technologies: Nanomaterials

9. 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