NICNAS Reforms

Consultation Paper 1

Purpose of workshop

• Explaining Consultation Paper 1 and seeking your input.

• Gathering information to inform Consultation Paper 2.

Structure of the workshopTopics to be covered:

•Objectives of reform•Consultation process and timing•Categorisation of chemicals •Class 1, 2 and 3 chemicals•Assessment process•Transitional arrangements •NICNAS initiated assessments•Confidential information•The matrix—exposure and hazard bands

Short break 10.45 – 11.00am

Short break 10.45 – 11.00am

Objectives of reform

• Assessment effort is more proportionate to risk.

• Maintain Australia’s health, safety and environmental protection standards.

• Greater use of international assessment materials.

• Reduction in regulatory burden ̴� ̴$23 million annually.

To deliver the reforms.. Changes required to:

• NICNAS’s legislation (ICNA Act) and associated regulations

• Guidance materials, application forms, standard operating procedures, and other supporting materials

• NICNAS’s information and communications technology (ICT) system.

Proposed consultation

• Consultation with the new NICNAS Strategic Consultative Committee

• Public release of detailed Consultation Papers

• Public workshops

• Consultation with all relevant Commonwealth agencies

Consultation process and timing

Any queries before we start?

Key elements of reforms

Key elements of reformsChemicals not on the AICS will be categorised by industry into 3 classes based on risk

• Class 1 (very low risk chemicals)—automatic entry, no notification to NICNAS (↓ time to market), post-market audits

• Class 2 (low risk chemicals)—notification to NICNAS, immediate entry to market (↓ time to market), post-market audits

• Class 3 (medium–high risk chemicals)—streamlined NICNAS

assessment, pathway to AICS, post-market audits

Process for chemical introduction

Categorisation of chemicals

Class 1 chemicals

Class 2 chemicals

Class 2 chemicals

Chemicals that meet hazard and exposure criteria for

health and/or environment

Additional information required in notification

Eligibility for international pathway based on “criteria for the adoption of international standards and risk assessments by Health portfolio regulators”

Risk Matrix pathway

Chemicals that meet Class 3 criteria with:•a comparable risk assessment (use, volume, concentration, conditions) AND•risk assessment assumptions and outcome relevant in Australian context AND•assessment from certain agencies

International pathway

International pathwayAssessed by:•Environment & Health Canada•SCCS and adopted by EU•evaluated by EU MSCA

Assessed both health and environment

Same use, volume and concentration (or less)

Relevant to Australia

International conditions of use

Assessment report available to NICNAS

We seek your input

• What is your advice regarding the international pathway?

• What are the strengths and limitations of the proposed approach?

Class 3 chemicals

Class 3 chemicals• Require pre-market assessment by NICNAS.

• Streamlined; international information (Health portfolio criteria).

• Flexible assessment process.

• A summary of the assessment published online.

• Targeted post-market audit/assessment.

• Estimated to be � ̴0.75% of new chemicals introduced ( � ̴100

assessments per year).NOTE: An introducer may also choose to seek NICNAS assessment of a Class 1 or Class 2 chemical—to provide a pathway to the AICS

(does not make it a Class 3 chemical).

Assessment process

• Streamlined assessment process.

• Overseas applicants could appoint a nominated local agent (harmonises with REACH).

• Electronic notifications and payment—ICT system.

• Automated completeness check of application.

• Changes to assessment timeframe, with increased certainty.

Some proposed changes

• NICNAS must consult with relevant risk managers if considering: a) imposing any conditions of use; orb) refusing an assessment certificate.

• NICNAS may consult risk managers at any time.

• NICNAS must consider the advice of risk managers.

• Proceed with assessment decision if no response received.

Consultation with risk managers

Assessment outcomes

Issue assessment certificate that:•is subject to a defined assessment scope;•may include recommendations to risk managers;•may include conditions of use—limited to volume, site or duration.

These will be on the certificate and transferred to the AICS.

Refuse assessment certificate:If risk cannot be managed by existing risk management frameworks or conditions of use.

Defined assessment scope: As a component of rinse-off

cosmetic products at concentration of less than 10%.

• NICNAS to publish a summary report.

• NICNAS to maintain a public register of risk management recommendations and responses.

Transparency

We seek your input

• Process and timeframes for input from risk managers?

• Information that should be included in a summary report?

• Overall timeframes?

Transitional arrangements

Transitional arrangements: new chemicals

•Proposed 6 month transition period• to self-categorise chemicals into classes and meet requirements if

they fall into Classes 1 or 2.

•Chemicals under permit that fall into Class 3 • certificate for the duration of the permit.

•Chemicals under certificate that fall into Class 3a. Certificate continues and chemical entered on AICS at 5 years; orb. Introducer may apply for early listing.

We seek your input on transitional arrangements

Is there a balance between allowing adequate time for transition, while minimising uncertainty (with two systems

operating)?

NICNAS initiated assessments

NICNAS Initiated Assessments (NIA)• NICNAS can initiate assessment (or reassessment) of a

chemical on AICS or under Class 1, 2 or 3 (i.e. any industrial chemical).

• Will replace the IMAP framework and PEC process.

• Key features of the IMAP framework will be relevant—e.g. prioritisation of chemicals for assessment, risk-based assessment approach, flexible approach to exposure information.

• IMAP review will inform approach to NIA.

National Industrial Chemicals Notification and Assessment Scheme

NICNAS Initiated AssessmentTriggers

Chemical on AICSOr Class 1, 2, or 3

certificate

Info gathering

Regulatory outcomes

NICNAS Initiated Assessments (NIA)

• New health, safety or environmental information

• Adverse event• Inter/national regulatory

action• Requested by risk manager

Actions that may trigger

process

Examples of information

gathering

External Internal

• Voluntary call for information• Mandatory call for

information—only under restricted conditions

• Specific concerns• Systematic NICNAS activity• NICNAS compliance activity

• Published literature, databases

• Inter/national liaison• NICNAS compliance activity

Mandatory calls for information

May be required if:

•a voluntary call has not provided adequate information•confirmation needed that a chemical is not being introduced•information is held by introducers•significant health or environmental concerns•banned by an international regulator•a defined assessment scope needs to be determined•required for international reporting obligations.

Possible outcomes of NIA• Recommendations to risk managers.

• Add or change: defined assessment scope (on assessment certificate or AICS) conditions of use (assessment certificate or AICS).

• Remove chemical from the AICS.

• Revoke assessment certificate.

• Recommendations to government for changes to legislative criteria for classes 1, 2 or 3.

Confidential information

Confidential information• Option of introducing a system using masked names in

certain circumstances.

• Masked name = one or more chemical elements have been removed (or made generic) in chemical name.

• Better international harmonisation (ECHA, US EPA and Environment Canada).

Confidential informationConsideration of:

•A single, one-off application for masking chemical name, not using the confidential section on the AICS

•Using agreed masked name for all publication purposes, including published assessment report and listing on the AICS, linking the report directly to chemical names on the AICS.

Your thoughts on this?

Cost recovery• Government policy of industry cost recovery will continue.

• New Cost Recovery Implementation Statement (CRIS) to be developed as detail of reforms becomes more settled.

• NICNAS fees and charges to be recalibrated, to match regulatory effort required.

Impact of reforms •Continued public health and safety and environment protections.•Reduced time to market.•Reduced annual reporting requirements.•Increased international harmonisation.

•Anticipated increase in post-market compliance monitoring and assessment effort.

Estimated overall decrease of >70% pre-market assessments: from ̴�3.3% to ̴�0.75% of all new chemicals introduced.

The risk matrix

Indicative risk matrixRIS Option 3—concept of indicative risk matrix:

• concept of chemical classes • based on chemical’s indicative risk• given its proposed use.

Criteria examples used in RIS were representative,

not definitive.

Criteria examples used in RIS were representative,

not definitive.

Indicative risk matrix• Following publication of NICNAS reforms implementation plan,

the concept was further developed with a focus on how the matrix would be used in practice.

• Practical considerations led to a number of improvements, articulated in Attachment A of Consultation Paper 1.

The current risk matricesHealth and Environment risks are evaluated separately, using a consistent approach:

Human Environment

Criteria for exposureExposure band

1

2

3

4

Research ̴and ̴development ̴≤100 ̴kg ̴per ̴annum; ̴orTransshipment.

Volume ̴≤1,000 ̴kg ̴non-consumer ̴use ̴per ̴annum; ̴orVolume ̴≤100  ̴kg ̴consumer ̴use ̴per ̴annum; ̴orConcentration ̴≤1 ̴% ̴as ̴introduced; ̴orResearch ̴and ̴development ̴>100 ̴kg ̴per ̴annum.

Volume ̴>1,000 ̴kg ̴non-consumer ̴use ̴per ̴annum; ̴orVolume ̴>100 ̴kg ̴consumer ̴use ̴per ̴annum ̴with ̴secondary ̴exposure.

Volume ̴>100 ̴kg ̴consumer ̴use ̴per ̴annum ̴with ̴primary ̴exposure.

Human

≤1,000 ̴kg ̴per ̴annum ̴release ̴volume ̴and ̴no ̴direct ̴release ̴to ̴the ̴environment.

>1000 ̴and ̴≤10,000 ̴kg ̴per ̴annum ̴release ̴volume ̴and ̴no ̴direct ̴release ̴to ̴the ̴environment; ̴orUnlimited ̴volume ̴only ̴if ̴bound ̴within ̴an ̴inert ̴matrix ̴(but ̴not ̴irreversibly ̴chemically ̴transformed).

Does ̴not ̴meet ̴the ̴criteria ̴for ̴environmental ̴exposure ̴bands ̴1, ̴2, ̴or ̴3.

Research ̴and ̴development ̴<100 ̴kg/year ̴release ̴volume, ̴provided ̴no ̴direct ̴release ̴to ̴the ̴environment; ̴chemical ̴treated ̴prior ̴to ̴release ̴into ̴sewer ̴or ̴landfill; ̴or ̴Transhipment.

Environment

Criteria for hazard—Hazard band A

Additional ̴assessment ̴considerations ̴apply ̴to ̴engineered ̴nanomaterials, ̴poly- ̴or ̴per-fluorinated ̴substances, ̴ultraviolet ̴filters ̴in ̴cosmetics ̴applied ̴to ̴skin, ̴and ̴chemical ̴transformation ̴and ̴degradation ̴products ̴of ̴environmental ̴concern.

Hazard band Health Environment

A • All indicators fall outside the criteria for Hazard Bands B–E; and

• Not a hazardous chemical for human health;

• Low acute toxicity via oral, dermal and inhalation routes of exposure; and

• Not irritating; and• Not sensitising; and• Not toxic to specific target

organs following single or repeated exposure; and

• Not mutagenic.

Chemicals that:do not meet the criteria for Hazard Bands B–E; andare readily biodegradable: >70% degradation in 28 days (and >60% degradation within a 10-day window); andare not bioaccumulative: bioconcentration factor (BCF) <2000 (or log KOW <4.2); andare not harmful to any aquatic life (fish, invertebrates and/or algae); andhave high molecular weight: MW >1000 Da.

Exposure ̴Band

Haz

ard ̴

Ban

dHow to read the risk matrix

Read across the exposure

Exposure ̴Band

Haz

ard ̴

Ban

d

From left to rightDetermine the band by the criterion that first applies to your chemical

Human ̴Health

Research ̴and ̴development ̴≤100 ̴kg ̴per ̴annum; ̴orTransshipment.

Volume ̴>100 ̴kg ̴consumer ̴use ̴per ̴annum ̴with ̴primary ̴exposure.

Volume ̴>1,000 ̴kg ̴non-consumer ̴use ̴per ̴annum; ̴orVolume ̴>100 ̴kg ̴consumer ̴use ̴per ̴annum ̴with ̴secondary ̴exposure.

Volume ̴≤1,000 ̴kg ̴non-consumer ̴use ̴per ̴annum; ̴orVolume ̴≤100  ̴kg ̴consumer ̴use ̴per ̴annum; ̴orConcentration ̴≤1 ̴% ̴as ̴introduced; ̴orResearch ̴and ̴development ̴>100 ̴kg ̴per ̴annum.

Haz

ard ̴

Ban

dRead down the hazard band

• No data means positive result assumed.

• Criterion first met for any of the hazards in a band, determines the band.

• The chemical’s hazard profile must be fully characterised.

Determine the chemical class

The higher of the two classes applies

Health Environment

An industrial chemical is proposed for introduction: •at up to 1,500 kg per annum•as a component of finished printing inks for paper at concentrations of ˂1%•used in commercial settings only (non-consumer use).

Its human health hazards include:•skin irritation•serious eye damage•serious damage to health by prolonged exposure through inhalation.

The chemical has:•negative in vitro test result for mutagenicity•no positive flags for carcinogenicity, reproductive toxicity or endocrine activity.

ExampleExample

Environmental considerations include:

•Expected environmental release: 50% of the import volume based on usage pattern (i.e. 750 kg) Released to sewer during paper recycling (i.e. no direct release).

•Environmental hazards include: Acute toxicity for fish = 57 mg/L Molecular weight < 1000 Da Not readily biodegradable Not expected to be bioaccumulative.

ExampleExample

Exposure Band

Indicative criteria for exposure band Human Health Environment

1 Research and development ≤100 kg per annum; or

Transshipment.

Research and development ≤100 kg per annum release volume, provided:

No direct release to the environment; and

The chemical is treated prior to release to sewer or landfill; or

Transshipment.2 Volume ≤1,000 kg non-consumer use per

annum; or Volume ≤100 kg consumer use per annum; or Concentration ≤1 % as introduced; or Research and development >100 kg per

annum.

≤1,000 kg per annum release volume and no direct release to the environment.

3 Volume >1,000 kg non-consumer use per annum; or

Volume >100 kg consumer use per annum with secondary exposure.

> 1000 and ≤ 10,000 kg per annum release volume and no direct release to the environment; or

Unlimited volume only if bound within an inert matrix.

4 Volume >100 kg consumer use per annum with primary exposure.

Does not meet the criteria for environmental exposure bands 1, 2, or 3

Determine the exposure band

Proposed:• Concentration ≤ 1% as introduced • Non-consumer use• Introduced at > 1,000 kg per annum• Expected release volume at < 1,000 kg per annum• No direct release

Determine the hazard bandDue to:

• Acutely harmful to aquatic life

• Negative in vitro test for mutagenicity

• Serious damage to eyes

Determine the chemical classHuman ̴Health Environment

Chemical in Exposure Band 2 and Hazard band D is categorised as Class 2 in proposed human health matrix.

Chemical in Exposure Band 2 and Hazard band B is categorised as Class 1 in proposed environment matrix.

The higher of the two classes applies.Chemical is in Class 2.

Considerations for Consultation Paper 2:

•not exceeding data requirements for current equivalent chemicals

•for hazards, data absence does not mean hazard absence

•hazard bands align with GHS classification

•separate guidance documents for analogues and (Q)SARs

•separate release volume calculators

•specific data requirements for polymers other than PLCs.

Health hazard data requirements

• Tiered approach• Tier 1: in silico screening; flags from authoritative lists• Tier 2: in vitro and/or in chemico, including AoP • Tier 3: in vivo on chemical and/or suitable analogue(s)

• Confidence: Tier 1 < Tier 2 < Tier 3

– Tier 1: may be sufficient for Exposure Band 1 and 2– Tier 2: may be sufficient for Exposure Band 2 and 3 – Tier 3: is required for Exposure Band 3 and 4

• Evaluation of the chemical’s physical/chemical properties, metabolism in the body and environmental fate, inform all tiers.

Health hazard data requirements

Next steps

For more information:

www.nicnas.gov.au 1800 638 528