The new chemicals risk matrices

Workshop focus use of new online categorisation tools criteria used to categorise new chemicals under the proposed framework case studies to illustrate the proposed regulatory treatment of new chemicals

a tool to help you understand the proposed framework if a chemical is assessed in one matrix and reported in another, the chemical will be Assessed Human HealthHuman Health Environment The matrices

Case study 1 chemical to be used in a cosmetic at up to 1.5 tonnes per annum introduced at 65% concentration used at up to 5% in finished products Current NICNAS scheme requires assessment under a standard assessment certificate category, with a 90- day assessment period and an assessment fee of $18,600.

Human HealthHuman Health cosmetic introduced at 1.5 tonnes 1.5 tonnes per annum 65% concentration Case study 1- human health

For a chemical in EB-4, the minimum information required is: find out if the chemical is a known carcinogen, reprotoxin, endocrine disrupter or nanomaterial mutagenicity/genotoxicity (at least two in vitro studies) acute toxicity (oral or other relevant route) skin corrosion/irritation eye damage/irritation sensitisation toxicity after repeated exposure (STOT) whether the chemical is a known respiratory irritant or aspiration hazard physical hazards e.g. flammability information Case study 1- human health

Required information for EB-4 Required information for EB-4 plus all additional information available not present on the authoritative lists for hazard band D hazards mutagenicity – in vitro tests on chemical – not a mutagen or genotoxin acute toxicity – study on an analogue – not acutely toxic skin corrosion/irritation – in vitro data on the chemical – not corrosive/irritating eye damage/irritation – study on an analogue – not damaging/irritating to the eye Case study 1- human health

Required information for EB-4 Required information for EB-4 plus all additional information available sensitisation – report on an analogue – not sensitising toxicity after repeated exposure –study on an analogue – not toxic following repeated exposure respiratory irritation/ aspiration hazard – not a known respiratory irritant or aspiration hazard physical hazards – data on the chemical – no physical hazards Case study 1- human health

Human HealthHuman Health cosmetic introduced at 1.5 tonnes per annum 65% concentration Exposure Band 4 Chemical is not hazardous according to the criteria Hazard Band A Case study 1- human health

Human HealthHuman Health Chemical will be Exempted for human health cosmetic introduced at 1.5 tonnes per annum 65% concentration Exposure Band 4 Chemical is not hazardous according to the criteria Hazard Band A Case study 1- human health

release volume = 1.5 tonnes per annum (introduction volume x release factor of 100% for cosmetics)1.5 tonnes ‘no direct release’ to the environment Exposure Band 4 Environment Case study 1 – environment

As a minimum, the introducer would be required to obtain information on whether the chemical is: a known concern to the environment (i.e. nanomaterial, an endocrine disrupting chemical, an ozone depleting chemical, a chemical containing a high concern inorganic element, or a perfluorinated or polyfluorinated chemical) bioaccumulative ecotoxic Ready biodegradation data will also be required if the chemical is potentially bioaccumulative and very toxic, or if the introducer wishes to demonstrate that the chemical is not hazardous. Case study 1 – environment

The introducer collected the required information plus all additional information available to them: not known to be of concern to the environment bioaccumulation – modelled log K OW – not bioaccumulative ecotoxicity – modelled ecotoxicity endpoints – not harmful ready biodegradation – study on an analogue – readily biodegradable Case study 1 – environment

Environment release volume of 1.5 tonne per annum ‘no direct release’ to the environment Exposure Band 4 Chemical is not known to be of concern to the environment not bioaccumulative not harmful readily biodegradable Hazard Band A Case study 1 – environment

Chemical is not known to be of concern to the environment not bioaccumulative not harmful readily biodegradable Hazard Band A Chemical will be Exempted for environment Environment release volume of 1.5 tonne per annum ‘no direct release’ to the environment Exposure Band 4 Case study 1 – environment

chemical categorised as Exempted on human health and environment criteria as an Exempted chemical, there is no fee for assessment or advice to NICNAS prior to introduction introducer may be audited for compliance with the criteria for classifying the chemical as Exempted Human HealthEnvironment Case study 1

up to 10 tonnes per annum as a raw material reformulated into surface coatings at concentrations up to 10% risk assessment for the chemical has been conducted by a trusted foreign regulator scope of the foreign risk assessment is the same as that proposed for Australia Current NICNAS scheme requires assessment under a standard assessment certificate category (approved foreign scheme), with a 90 day assessment period and an assessment fee of $13,700. Case study 2

chemical introduced at up to 10 tonnes per annum as a raw materialup to 10 tonnes used in surface coatings at up to 10% Exposure Band 3 Human Health Case study 2- human health

For a chemical in EB-3, the minimum information required is: whether the chemical is a known carcinogen, reprotoxin, endocrine disrupter or nanomaterial mutagenicity (at least one in vitro study) acute toxicity (oral or other relevant route) skin corrosion eye damage sensitisation

Information on the chemical not present on the authoritative lists for Hazard Band D hazards mutagenicity – in vitro study on the chemical – not mutagenic acute toxicity – study on an analogue – not acutely toxic sensitisation – study on an analogue – not sensitising skin corrosion – in vitro study on the chemical – corrosive to skin eye damage – study on an analogue –causes eye damage Hazard Band C The introducer may stop assessing the hazards here Case study 2- human health

Human HealthHuman Health chemical introduced at up to 10 tonnes per annum used in surface coatings at up to 10% Exposure Band 3 Chemical is corrosive Hazard Band C Case study 2- human health

Human HealthHuman Health Chemical would be Assessedfor human health Chemical is corrosive Hazard Band C chemical introduced at up to 10 tonnes per annum used in surface coatings at up to 10% Exposure Band 3 Case study 2- human health

introduced at up to 10 tonnes per annumup to 10 tonnes used in surface coatings assuming 5% release volume => up to 0.5 tonnes ‘no direct release’ to the environment Environment Case study 2 – environment

As a minimum, the introducer would be required to obtain information on whether the chemical is: a known concern to the environment (i.e. nanomaterial, an endocrine disrupting chemical, an ozone depleting chemical, a chemical containing a high concern inorganic elements, or a perfluorinated or polyfluorinated chemical) bioaccumulative ecotoxic Ready biodegradation data will also be required if the chemical is potentially bioaccumulative and very toxic, or introducer wishes to demonstrate that the chemical is not hazardous.

The introducer collected the required information plus all additional information available to them: not known to be of concern to the environment bioaccumulation – modelled log K OW – not bioaccumulative ecotoxicity – existing measured data on chemical – very toxic to algae Case study 2 – environment

Environment Release volume up to 0.5 tonnes Exposure Band 3 Chemical is very toxic to algae Hazard Band D Case study 2 – environment

Environment Release volume up to 0.5 tonnes Exposure Band 3 Chemical is very toxic to algae Hazard Band D Chemical will be Reported for environment Case study 2 – environment

chemical is Assessed under human health criteria and Reported under environment criteria chemical would be an Assessed chemical and the introducer would be required to seek a NICNAS assessment assessment would be streamlined and would focus on the human health risk Human HealthEnvironment Case study 2

introducer has permission to use an assessment on the same chemical by a trusted foreign scheme chemical can therefore be introduced as a Reported chemical to import a reported chemical, complete a simple online advice chemical may be subject to post market audit Human HealthEnvironment Case study 2 – international pathway

fragrance chemical introduction volume up to 200 kg per annum imported at 10% for reformulation into cosmetic products a maximum of 0.5% concentration Under the current arrangements, this would require assessment by NICNAS under a Limited Assessment certificate category, with a 90 day assessment period and an assessment fee of $13,300. Case study 3

cosmetic ingredient introduced at a volume of 200 kg200 kg imported at 10% concentration Exposure Band 3 Human Health Case study 3 – human health

For a chemical in EB-3, the minimum information required is: whether the chemical is a known carcinogen, reprotoxin, endocrine disrupter or nanomaterial Mutagenicity Acute toxicity (oral or other relevant route) Skin corrosion Eye damage Sensitisation Case study 3 – human health

Information on the chemical not present on the authoritative lists for Hazard Band D hazards mutagenicity – two in vitro studies on the chemical – not mutagenic or genotoxic acute toxicity – study on an analogue – not acutely toxic sensitisation – study on the chemical and a HRIPT – sensitising Case study 3 – human health

Information on the chemical: skin corrosion/irritation – in vitro assay on the chemical – slight irritation with reversible effects eye damage/irritation – study on an analogue – slight irritation repeat dose toxicity assay – 28 day study on the chemical – NOAEL 150mg/kg bw/day – low repeat dose toxicity Introducer had a repeat dose toxicity assay – noting that this is not a requirement for Exposure Band 3 Case study 3 – human health

Human HealthHuman Health cosmetic ingredient introduced at a volume of 200 kg per annum200 kg up to 10% concentration Exposure Band 3 Chemical is a skin sensitiser Hazard Band C Case study 3 – human health

Human HealthHuman Health Chemical is a skin sensitiser Hazard Band C Chemical will be Assessed for human health cosmetic ingredient introduced at a volume of 200 kg per annum200 kg up to 10% concentration Exposure Band 3 Case study 3 – human health

Release volume = 200 kg per annum (introduction volume x release factor of 100% for cosmetics)200 kg ‘no direct release’ to the environment Environment Case study 3 – environment

As a minimum, the introducer would be required to obtain information on whether the chemical is: a known concern to the environment (i.e. nanomaterial, an endocrine disrupting chemical, an ozone depleting chemical, a chemical containing a high concern inorganic elements, or a perfluorinated or polyfluorinated chemical) bioaccumulative ecotoxic Ready biodegradation data will also be required if the chemical is potentially bioaccumulative and very toxic, or introducer wishes to demonstrate that the chemical is not hazardous.

The introducer collected the required information plus all additional information available to them: not known to be of concern to the environment bioaccumulation – modelled log K OW – not bioaccumulative Ecotoxicity – modelled ecotoxicity endpoints – toxic to fish Case study 3 – environment

Environment cosmetic with a release volume of 200 kg per annum200 kg ‘No direct release’ to the environment Exposure Band 3 Chemical is toxic to fish Hazard Band C Case study 3 – environment

Hazard Band C Chemical will be Reported for environment Environment cosmetic with a release volume of 200 kg per annum200 kg ‘No direct release’ to the environment Exposure Band 3 Chemical is toxic to fish Case study 3 – environment

chemical categorised as Reported under environment criteria and Assessed under human health chemical would therefore be Assessed assessment would focus on human health NICNAS would briefly review relevant environmental information to confirm it is ‘low risk’ to the environment as the chemical would eventually be added to AICS. introducer must complete an online notification providing all relevant information for the exposure band and pay a fee NICNAS will complete an assessment and publish an assessment statement The assessment may result in recommendations to risk managers Case study 3

raw chemical used in off-shore and on-shore oil and gas drilling introduced at 100 tonnes per annum 70% for off-shore use with disposal of drilling mud to the ocean (i.e. direct release to the environment) Current NICNAS scheme requires assessment under a standard assessment certificate category, with a 90-day assessment period and an assessment fee of $18,600. Case study 4

raw chemical for oil and gas industry introduced at 100 tonnes per annum100 tonnes Exposure Band 4 Human Health Case study 4 – human health

For a chemical in EB-4, the minimum information required is: find out if the chemical is a known carcinogen, reprotoxin, endocrine disrupter or nanomaterial mutagenicity/genotoxicity (at least two in vitro studies) acute toxicity (oral or other relevant route) skin corrosion/irritation eye damage/irritation sensitisation toxicity after repeated exposure (STOT) whether the chemical is a known respiratory irritant or aspiration hazard physical hazards e.g. flammability information Case study 4 – human health

Required information for EB-4 Required information for EB-4 plus all additional information available not present on the authoritative lists for hazard band D hazards mutagenicity – in vitro tests on chemical – not a mutagen or genotoxin acute toxicity – study on an analogue – not acutely toxic skin corrosion/irritation – in vitro data on the chemical – irritating to the skin eye damage/irritation – study on an analogue – irritating to the eye Case study 4 – human health

Required information for EB-4 Required information for EB-4 plus all additional information available sensitisation – study on an analogue – not sensitising toxicity after repeated exposure –study on an analogue – not toxic following repeated exposure respiratory irritation/ aspiration hazard – not a known respiratory irritant or aspiration hazard physical hazards – data on the chemical – no physical hazards Case study 4 – human health

Human HealthHuman Health Chemical is irritating to the skin and eye Hazard Band B raw chemical for oil and gas industry introduced at 100 tonnes per annum Exposure Band 4 Case study 4 – human health

Chemical will be Reported for human health Human HealthHuman Health Chemical is irritating to the skin and eye Hazard Band B raw chemical for oil and gas industry introduced at 100 tonnes per annum Exposure Band 4 Case study 4 – human health

raw chemical used in off-shore and on-shore oil and gas drilling introduced at 100 tonnes per annum; 70% direct release to the environmentdirect release to the environment Exposure Band 5 Environment Case study 4 – environment

Case study 4 – environment As a minimum, the introducer would be required to obtain information on whether the chemical is: a known concern to the environment (i.e. nanomaterial, an endocrine disrupting chemical, an ozone depleting chemical, a chemical containing a high concern inorganic elements, or a perfluorinated or polyfluorinated chemical) bioaccumulative ecotoxic Ready biodegradation data will also be required if the chemical is potentially bioaccumulative and very toxic, or introducer wishes to demonstrate that the chemical is not hazardous.

The introducer collected the required information plus all additional information available to them: not known to be of concern to the environment bioaccumulation – modelled log Kow– potentially bioaccumulative ecotoxicity – modelled data on chemical– very toxic to fish ready biodegradation – Study on an analogue – readily biodegradable Case study 4 – environment

Environment raw chemical used in off-shore and on-shore oil and gas drilling introduced at 100 tonnes per annum; 70% direct release to the environment Exposure Band 5 Chemical is very toxic to fish Hazard Band D Case study 4 – environment

Environment Chemical is very toxic to fish Hazard Band D Chemical will be Assessed for environment raw chemical used in off-shore and on-shore oil and gas drilling introduced at 100 tonnes per annum; 70% direct release to the environment Exposure Band 5 Case study 4 – environment

chemical categorised as Assessed under environmental criteria and Reported under human health criteria chemical would therefore be Assessed assessment would focus on environment as the chemical is categorised as Assessed measured data for the chemical (or an analogue) would need to be submitted for the endpoints:  bioaccumulation (measured log K ow, BCF, BAF, or BMF)  ecotoxicity (studies for fish, aquatic invertebrates and algae)  persistence (the ready biodegradation study on the analogue) Case study 4

NICNAS would briefly review relevant human health information to confirm it is ‘low risk’ to human health as the chemical would eventually be added to AICS. introducer must complete an online notification providing all relevant information for the exposure band and pay a fee NICNAS will complete an assessment and publish an assessment statement The assessment may result in recommendations to risk managers Case study 4

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