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 Banned Use or uses prohibited by the final regulatory action: All formulations, products, and parts of products containing greater than or equal to 0,1 % by weight of pentabromodiphenyl ether. The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: It is prohibited to produce, import, export, sell and use pentabromodiphenyl ether in pure form, in preparations, in products, and in parts of products containing greater than or equal to 0,1 % by weight of pentabromodiphenyl ether. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: There is concern for serious damage to human health by prolonged exposure and concern for breastfed babies. The available information regarding the absorption, metabolism and excretion of pentaBDE in humans and animals suggests that pentaBDE may be well absorbed by all routes of exposure. Once absorbed there appears to be little metabolism. PentaBDE and/or its metabolites are distributed to and retain in fatty tissue. Excretion occurs via the biliary and faecal routes, as well as via breast milk. Effects of repeated exposure to pentaBDE consistently indicate that the liver is the key target organ, and liver effects have been observed in animal studies. The effects observed include increases in liver weight and hepatocytomegaly with histopathological changes, induction of a range of liver enzymes, and disturbances in cholesterol and porphyrin synthesis. Arctic and Northern areas are considered to be especially affected by pentaBDE as such substances travel with currents and air towards colder areas where it is settled out. A lot of research has been done in Norway to determine exposure of humans to pentaBDE and in a screening study in 2002, pentaBDE was found in most compartments of the Norwegian environment (SFT, 2002). Food, and mainly fish, is considered to be an important route of exposure in Norway (VKM, 2005). This is alarming, especially for populations that are dependent of fish in their diet (e.g. indigenous people). In Norway, pentaBDE has been found in human serum samples (Thomsen et.al, 2002) and in human breast milk (Thomsen et. al, 2003). The latter is especially alarming, since infants are considered to be among the most vulnerable. References: SFT, 2002, Norwegian Pollution Control Authority, Screening of brominated flame retardants and chlorinated paraffins. TA-1924/2002 (Only in Norwegian). VKM, 2005, Norwegian Scientific Committee for food safety, Risk assessment of PBDE. 04/504 (Only in Norwegian). Thomsen, C., Frshaug, M., Leknes, H., and Becher, G., 2003, Brominated flame retardants in breast milk form Norway. Organohalogen compounds, 64, 33-36. Thomsen, C., Lundanes, E., and Becher, G., 2003, Brominated flame retardants in archived serum samples form Norway. Organohalogen compounds, 64, 33-36. Expected effect of the final regulatory action in relation to human health: Reduction of risk to human health. Summary of known hazards and risks to the environment: The evaluation of this chemical gives rise to serious concern for long term effects in the environment. According to available data, pentaBDE resists abiotic and biotic degradation and thus persists in the environment for a long time. It has a great potential for bioaccumulation and in addition there is monitoring evidence of its biomagnification. Due to its physical and chemical properties and its considerably long atmospheric half-life, it can be assumed that pentaBDE can be transported long distances in air. The data on the bioaccumulation, persistence and potential for long range transport of pentaBDE are supported by monitoring. Available data from remote areas clearly show contamination of biota and air by pentaBDE. In Norway, congeners of pentaBDE have been found in a variety of abiotic and biotic samples. It has been detected in, e.g. human samples (in 2.4.2.1), as well as in cod-liver and mussels. High levels of PBDEs were found in fish from the Norwegian lake Mjsa (NIVA, 2001). This observation led to further studies which also detected significant amounts of PBDEs in sediments and fish at different locations in Norway (SFT, 2002; SFT, 2004). In a more resent study from Svalbard, Norway, pentaBDE was found to bioaccumulate in zooplankton, polar cod, and ringed seals. Evidence was also found in this study that congeners of pentaBDE biomagnify in the Arctic food chain (Srmo et.al, 2006). References: NIVA, 2001, Norwegian Institute for Water Research, Halogenerte organiske miljgifter og kvikkslv i norsk ferskvannsfisk, 1995-1999. NIVA report 4402-01 (Only in Norwegian). SFT, 2002, Norwegian Pollution Control Authority, Screening of brominated flame retardants and chlorinated paraffins. TA-1924/2002 (Only in Norwegian). SFT, 2004, Norwegian Pollution Control Authority, Screening of selected new organic contaminants - brominated flame retardants, chlorinated paraffins, bisphenol-A and trichlosan. TA-2006/2004 (Only in Norwegian). Srmo, E.G., Salmer, M.P., Jenssen, B.M., Hop, H., Bk, K., Kovacs, K.M., Lydersen, C., Falk-Pettersen, S., Gabrielsen, G.W., Lie, E., Skaare, J.U., 2006 Biomagnification of polybrominated diphenyl ether and hexabromocyclododecane flame retardants in polar bear food chain in Svalbard, Norway. Environmental toxicology and chemistry, Vol 25, nr 9, pp. 2502-2511. Expected effect of the final regulatory action in relation to the environment: Reduction of risk to the environment. Date of entry into force of the final regulatory action: 01/07/2004 |