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 Banned

Use or uses prohibited by the final regulatory action:

All formulations, products and parts of products containing greater than or equal to 0,l % by weight of octabromodiphenyl 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 octabromodiphenyl ether in pure form, in preparations, in products, and in parts of products containing greater than or equal to 0.1% by weight of octabromodiphenyl ether.

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

Summary of known hazards and risks to human health:

C-octaBDE is classified as "Toxic", due to its effects on human health, with the risk phrases "may cause harm to unborn child", and "possible risk of impaired fertility". Studies and assessments provide evidence that c-octaBDE may cause adverse effect such as effects on reproductive organs and developmental effects. Effects of repeated exposure to c-octaBDE consistently indicate that the liver is the key target organ, and liver effects have been observed in animal studies. It is assumed that in humans components of octaBDE might bioaccumulate in adipose tissue.

The EU Risk Assessment Report presents information on the levels of components of c-octaBDE measured in human samples including human milk, blood, and adipose tissue. Large variations among individuals are generally observed, but significant differences between the control population and occupationally exposed groups are also reported. Plasma concentrations of polybrominated diphenyl ether (PBDE) were determined in three Norwegian occupational groups (Thomsen et al., 2001). Samples were obtained from three groups of five individuals each working a) at an electronics dismantling facility, b) in production of printed circuit boards, and c) in an analytical laboratory. HeptaBDE was only identified in plasma from electronics dismantling plant personnel whereas hexaBDE was detected in each occupational group with higher plasma levels at the electronics dismantling plant compared to the other groups. No data on octaBDE was reported.

Thomsen et al., 2007, investigated the levels of PBDE's in 21 pooled serum samples archived from the general Norwegian population (from 1977 to 2003). In serum from men (age 40-50 years) the sum of seven PBDE congeners (28, 47, 99, 100, 153, 154 and 183) increased from 1977 (0.5 nglg llpids) to 1998 (4.8 nglg lipids). From 1999 to 2003 the concentration of PBDE's seems to have stabilized.

In another Norwegian study (Thomsen et al., 2006) the investigation of 66 hobby fishermen and women showed clear associations between the concentrations of PBDE's (including BDE-153, BDE-154, BDE-138 and BDE-183) in serum and the subjects' age and intake of freshwater fish.

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:

According to available data, congeners of c-octaBDE seem to resist degradation and thus have the potential to persist in the environment for a long time. They have potential for bioaccumulation and in addition there is monitoring evidence of biomagnification. Lower and higher brominated congeners (some of them present in c-octaBDE) show potential for long-range environmental transport. Analysis of c-octaBDE's chemical properties seems to support this conclusion, as Henry's law constant is very similar to those of acknowledged POPS. Therefore, it can be expected that c-octaBDE is subject to long range environmental transport.

Available monitoring data indicate that, as well as hexaBDErs, some heptaBDE's have recently been found to be present in organisms in the environment. This shows that uptake of some of the main components of the c-octaBDE ether is occurring in the environment. Knudsen et a1 (2005) reviewed temporal trends of PBDE's in eggs from three bird species, three locations and three sampling times (from 1983 to 2003) from Northern Norway. Spatial differences were only observed for hexaBDE (BDE-153), and increases in the measured concentration from 1983 to 2003 were observed for the hexaBDE (153 and 154) and the heptaBDE (BDE-183).

In Norway, congeners of c-octaBDE have been found in a variety samples. It has been detected in, e.g. human samples (in 2.4.2.1), as well as in polar cod, ringed seals and mussels. In a study from Svalbard, Norway, congeners of coctaBDE were found to bioaccumulate in zooplankton, polar cod, and ringed seals. Evidence was also found in this study that hexaBDE (BDE-153) biomagnify in the Arctic food chain (ringed seal to polar bear) (Sarmo et.al, 2006).

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