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Australia - Final Regulatory Action
Pentabromodiphenyl ether CAS number:
32534-81-9		 Date circular:
12/06/2022

Chemical name: Benzene, 1,1’-oxybis-, pentabromo derivative, Benzene, 1,2,3,4,5-pentabromo-6-phenoxy-

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:

All uses prohibited as documented in 2.3.1.

Use or uses that remain allowed:

No uses are allowed.

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

Summary of the final regulatory action:

Consistent with the requirements under the Industrial Chemicals Act 2019, sections: 95, 159(2), the Executive Director of the Australian Industrial Chemicals Introduction Scheme (AICIS) declares that:
Pentabromodiphenyl ether CAS Number - 32534-81-9 - was removed from the Australian Inventory of Industrial Chemicals on 10 December 2021. This will severely restrict the introduction 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:

HUMAN HEALTH
Summary of Health Hazards
The critical health effects for risk characterisation include:
Liver effects, changes in neuro-behavioural development, reproductive organs and thyroxine levels following repeated oral exposure; and
Presence in human breast milk in Australia.
Health 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 work health and safety:
Health Hazard Hazard Category Hazard Statement
Specific target organ toxicity - repeated exposure STOT Repeated Exposure 2 H373: May cause damage to organs through prolonged or repeated exposure
Reproductive Toxicity Effects on or via lactation H362: May cause harm to breast-fed children
Public
Given the neuro-behavioural, developmental and reproductive effects in the offspring of experimental animals exposed to pentaBDE, the potential for these effects to occur in humans cannot be ruled out.
Repeated exposure to pentaBDE has resulted in perturbation of the thyroid hormone homeostasis.
Exposure to pentaBDE via the reintroduction of manufacture or import, and the subsequent use of pentaBDE could pose a risk to the public based on the critical health effects and potential for exposure.
There is a global phase-out of manufacture and use of pentaBDE. Accordingly, public exposure from use of articles containing pentaBDE is expected to decline to minimal levels as the articles reach the end of their useful life.
Workers
The major route of occupational exposure from pentaBDE is through the release of articles in use, especially foam furnishings manufactured or imported from the past. Exposure will be widespread, especially among office workers.
However, as articles containing pentaBDE are no longer imported into Australia, occupational exposure from use of articles is expected to decline to minimal levels due to the global phase-out containing pentaBDE.
PentaBDE could continue posing a risk to workers if the chemical is reintroduced in the form of pure chemical or chemical mixtures into Australia, or in articles containing pentaBDE.
For both the Public and Workers
Regulatory controls should be in place to mitigate potential human and environmental risks associated with the public and worker exposure resulting from the reintroduction by manufacture in Australia or importation, and the subsequent use of pentaBDE.

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

Importation of pentaBDE into Australia will be restricted and the health of workers and the public will be protected.

Summary of known hazards and risks to the environment:

ENVIRONMENT
Summary of Environmental Hazard Characteristics
Based on available ecotoxicity and test data:
PentaBDE can be released and distributed into the environment through many channels including:
oRelease into the atmosphere or wastewater from its industrial uses and disposal;
oEmission or dust from pentaBDE-containing articles; and
oLeaching and emission from landfill.
PentaBDE is considered to be very toxic to aquatic organisms.
PentaBDE can bioaccumulate in fish, and biomagnification of the chemical can occur in birds that eat the contaminated fish.
Congeners found in pentaBDE are bioaccumulative and can biomagnify through the food chain.
Sediment organisms have the potential to accumulate congeners found in pentaBDE when exposed through sediment with bioaccumulation factors of 4 (BDE-99) to 9.1 (BDE-154) found for tetra-through to hexabrominated congeners (NICNAS 2020).
PentaBDE located in remote regions that are removed from major sources of emissions show that pentaBDE and the congeners in pentaBDE can undergo long range transport (LRT) in the environment (NICNAS 2020).
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:
Environmental Hazard Hazard Category Hazard Statement
Acute Aquatic Aquatic Acute 1 H400: Very toxic to aquatic life
Chronic Aquatic 		Aquatic Chronic 1 H410: Very toxic to aquatic life with long lasting effec
Summary of Environmental Risk
Under environmental conditions, pentaBDE is persistent and bioaccumulative, and is very toxic to aquatic organisms.
PentaBDE meets the persistence, bioaccumulation potential for long-range environmental transport and adverse effects in aquatic life criteria of Annex D of the Stockholm Convention.
As a Persistent Organic Pollutant, pentaBDE causes very significant long-term risks to the environment from its manufacture, import and/or use.
Any reintroduction of pentaBDE would increase the already significant environmental risks identified from past environmental exposure to pentaBDE. Subsequently, regulatory controls should be implemented to ensure that manufacture, import and use of pentaBDE remains prohibited in Australia.

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

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

Date of entry into force of the final regulatory action: 10/12/2021