Chemicals Regulation – Global Challenges
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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

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Chemicals Regulation – Global ChallengesChallenges and Opportunities in Australia

Marion Healy



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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

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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

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1. Existing Chemicals: Implications of Other Schemes

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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

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2. New Chemicals:

Impact of Initiatives

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3. Regulatory Principles for New Technologies


  • 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.


  • Ability to review decisions as new evidence becomes available.


  • 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.

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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