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:

Not relevant

All applications where concentration exceed 0.1%.

Use or uses that remain allowed:

EC Member States shall apply the laws, regulations and administrative provisions necessary to comply with the Directive as from 15 August 2004.

Concentrations lower than 0.1% will remain allowed thereafter.

Pesticide use or uses that remain allowed:

No known agricultural uses - not relevant

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

Summary of the final regulatory action:

The placing on the market and use of diphenylether, pentabromo derivative C₁₂^H₅^Br₅^{O is prohibited:}

^{1.as a substance or as a constituent of substances or of preparations in concentrations higher than 0.1% by mass}

^{2.in articles if they, or flame retardant parts thereof, contain the substance in concentrations higher than 0.1% by mass.}

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

Summary of known hazards and risks to human health:

The conclusion of the evaluation concerning the risks to workers were that the estimated body burden of pentaBDE arising from occupational exposure, chiefly via dermal contact, is approximately 4-fold greater that the NOAEL derived from the rodent study (liver effects). In order to adequately characterise the risk, additional data were needed, including:

dermal exposure data on workers

the extent of dermal absorption (quantitative data)

health surveillance to investigate signs of chloracne in workers,

risk characterisation methodology for bioaccumulative substance (lifetime exposure).

The conclusions concerning the risks for humans exposed via the environment were that there were considerable uncertainties associated both with the toxicity data available and the approach to the risk characterisation for a bioaccumulative substance. In addition, there were uncertainties with respect to the modelled exposure data used for local sources of exposure. Consequently further information was required.

The CSTEE also underlined that despite the fact that exposure to consumers from PeBDE-containing foams seems negligible, the analyses of human breast milk indicate a continuous increase of PeBDE over the period 1972 to 1997. This was in contrast to the environmental concentrations which have levelled out or are decreasing over the last decade. This would indicate another exposure pathway for humans, which may be exposure from consumer goods.

The conclusions concerning the risks to infants exposed via breast milk and cows' milk were that further information was needed to adequately characterise the risks, mainly as regards:

the toxicokinetics of the substance with respect to breast milk including uptake from breast milk into the infant, the time course of the excretion via breast milk during lactation in humans and the future trend in levels in human breast milk.

the relative toxicity to the liver of the substance in young and adult animals,

exposure estimates from local and regional sources on the concentration of the substance in cows' milk

A multi-generation reproduction study was necessary in order to investigate whether or not other effects might be observed through exposure to breast milk and address the issue of whether or not the young animal is more sensitive to liver effects and whether or not differences in behaviour are produced.

However, there wre concerns that it would take time to gather the information and that the resulting refined risk assessment could then confirm a risk to breast-feeding infants. Furthermore, the bioaccumulative properties of the substance could cause concentrations in breast milk to rise while the data was being gathered. Consequently regulatory action was considered necessary.

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

Reduction of risk to human health from exposure to PentaBDE.

Summary of known hazards and risks to the environment:

The evaluation concerning the risks to the environment concluded that in relation to the aquatic ecosystems and terrestrial ecosystem there were concerns as regards:

effects on the local aquatic (sediment) and terrestrial environment as a consequence of exposure arising from polyurethane foam production,

secondary poisoning to the environmental spheres mentioned above both locally and regionally as a consequence of exposure arising from production and/or use of polyurethane foams.

It was concluded that marketing and use restrictions were needed for the substance and articles containing the substance, in order to control secondary poisoning risks arising from the production and use of polyurethane foams.

These measures will also reduce human exposure to the substance.

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

Reduction of risk to the environment from exposure to PentaBDE at a local and regional level within the EU.

Date of entry into force of the final regulatory action: 15/02/2003

Directive 2003/11/EC entered into force on the day of its publication in the Official Journal of the European Union (ie 15 February 2003). The EC Member States shall apply the laws, regulations and administrative provisions necessary to comply with the Directive as from 15 August 2004.