Chemical name: Benzene, 1,1'-(1,2-ethanediyl)bis[2,3,4,5,6-pentabromo-

Final regulatory action has been taken for the category: Industrial

Final regulatory action: The chemical is Severely Restricted

Use or uses prohibited by the final regulatory action:

Introduction of the chemical into Australia and proposed uses are severely restricted.

Use or uses that remain allowed:

The chemical may be used for research and development and not be made available to the public. Appropriate procedures and safety controls must be in place to eliminate or minimise the risks from the introduction to humans and the environment.

The final regulatory action was based on a risk or hazard evaluation: Yes

Summary of the final regulatory action:

In accordance with Section 52 of the Industrial Chemicals Act 2019 (Cth), the Executive Director of the Australian Industrial Chemicals Introduction Scheme (AICIS) declares that:

The assessment certificate for decabromodiphenylethane (CAS Number 84852-53-9) has been cancelled. This severely restricts the introduction and/or use of this chemical as defined in the Rotterdam convention.

The reasons for the final regulatory action were relevant to: Human health and environment

Summary of known hazards and risks to human health:

In Australia, DBDPE is for industrial use only.

The chemical is of low acute toxicity, not irritating to skin, is slightly irritating to eyes, not a skin sensitiser and is not mutagenic or genotoxic. Some repeated dose toxicity studies suggest that adverse effects after repeated exposure to the chemical cannot be ruled out. In some studies where decabromodiphenyl ether was also tested, the chemical was reported to be causing similar but less severe effects than with decabromodiphenyl ether.

No risks are identified for public health through direct exposure. However, the general public may have limited contact with articles containing DBDPE, as it is expected to be already imported into Australia as a component of a range of articles. Indirect exposure of humans through the environment may occur and this could increase over time due to the persistent and bioaccumulative properties of DBDPE.

Workers may be exposed to the imported DBDPE up to 100% concentration (powder form) during compounding/masterbatch production operations. Other workers may come into contact with DBDPE at = 30% concentration. Noting the uncertainties in human health hazards with repeated exposure, and provided that control measures are in place to minimise worker exposure, the risk to the health of workers from use of the assessed chemical is not considered to be significant.

Expected effect of the final regulatory action in relation to human health:

The expected effect of the final regulatory action is that it will reduce the potential risk posed by DBDPE to human health.

Summary of known hazards and risks to the environment:

Based on available ecotoxicity and test data:

·DBDPE can be released through the following pathways:

oRelease to the atmosphere, soil and wastewater from its industrial uses and disposal

oEmissions from treated articles, including breakdown of the article matrix

oLeaching and emission from landfill

·DBDPE is persistent in soils and sediments.

·DBDPE can bioaccumulate within aquatic and terrestrial organisms with biomagnification also occurring in some food chains.

·DPBPE has the potential to cause adverse effects in birds at environmentally relevant concentrations

·Monitoring in remote regions that are removed from major sources of emissions show that DBDPE and congeners of DBDPE can undergo long range transport (LRT) in the environment.

Environmental Hazard Classification

The chemical satisfies the criteria for classification according to the Globally Harmonised System of Classification and Labelling of Chemicals (GHE) (UNECE 2017) for hazard classes relevant to the environment:

HazardGHS Classification (Code)Hazard statementAcute AquaticNot classified-Chronic Aquatic Category 4 (H413)May cause long lasting harmful effects to aquatic life

Summary:

·DBDPE meets the persistence, bioaccumulation, adverse effects in aquatic and terrestrial organisms and long-range environmental transport criteria of Annex D of the Stockholm Convention.

·DBDPE has the potential to cause significant long-term risks to the environment from its introduction or use.

·Any reintroduction of DBDPE would increase the environmental risks resulting from past environmental exposure to DBDPE. Consequently, regulatory controls should be implemented to ensure that manufacture, import and use of DBDPE remains severely restricted in Australia.

Expected effect of the final regulatory action in relation to the environment:

By severely restricting DBDPE, it is anticipated that the environment will be protected from the identified adverse effects of this chemical.

Date of entry into force of the final regulatory action: 28/06/2022