Chemical name: Benzene, 1,1'-oxybis[2,3,4,5-tetrabromo- 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 applications where concentration exceeds 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 therafter. 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, octabromo derivative C12H2Br8O is prohibited as follows: 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 conclusions of the evaluation concerning the risks to workers were: 1.concerns were identified about possible transthyretin-T4 competition with octabromodiphenyl ether as well about the extent of excretion of commercial octabromodiphenyl ether into the breast milk and the potential effects of prolonged exposure. 2.as regards exposure through manufacturing (bagging and cleaning activities) and compounding and master batching (bag emptying), the following concerns were identified: - systemic effects after inhalation and dermal repeated exposure - local effects in the respiratory tract after inhalation repeated exposure, and - effects on female fertility after inhalation and dermal repeated exposure. The conclusion concerning the risks for humans exposed via the environment were that: the safe use of octabromodiphenyl ether was not established using the available information, since further information was needed on emissions into the enviroment from use or on soil-plant transfer and for exposure from local and regional sources on the concentration of octabromodiphenyl ether in cows. Concerns were identified on the extent of excretion of commercial octabromodiphenyl ether into breast milk and cow's milk, as well as on transthyretin-T4 competition with octabromodiphenyl ether and on the effects of prolonged exposure. Expected effect of the final regulatory action in relation to human health: Reduction of risk to human health from exposure to OctaBDE Summary of known hazards and risks to the environment: The conclusions of evaluation concerning the risks to the environment were as follows: 1.There was a need for further information and/or testing as regards the risk of secondary poisoning from all sources of octabromodiphenyl ether. The PEC/PNEC (Predicted Environmental Concentration /Predicted No Effect Concentration) approach used for secondary poisoning may not be appropriate, and may have underestimated the risk. A second aspect of the concern for secondary poisoning was that although the substance is persistent, there is evidence that it can degrade under some conditions to more toxic and bioaccumulative compounds. There is a high level of uncertainty associated with the suitability of the current risk assessment approach for secondary poisoning and the debromination issue. The combination of uncertainties raises a concern about the possibility of long-term environmental effects that can not easily be predicted. this uncertainty was sufficient to warrant regulatory action. 2.of particular concern was the risk of secondary poisoning via the earthworm route for the hexabromobiphenyl ether component in the commercial octabromobiphenyl ether product from the use in polymer applications. Expected effect of the final regulatory action in relation to the environment: Reduction of risk to the environment from exposure to octaBDE at a local and regional level within the EC. 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 (i.e. 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. |