Chemical name: Benzene, 1,1'-oxybis[2,3,4,5,6-pentabromo- 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: Decabromodiphenyl ether is regulated by 2-7 and 2a-3 of the Regulations relating to restrictions on the manufacture, import, export, sale and use of chemicals and other products hazardous to health and the environment (Product Regulations), Act no. 922 of 1 June 2004. Chapter 2. Regulated substances, preparations and products 2-7. Brominated flame retardants It is prohibited to manufacture, import, export, place on the market and use substances or preparations that contain 0.1 per cent by weight or more of decabromodiphenyl ether (CAS No. 1163-19-5). It is prohibited to manufacture, import, export and place on the market products or flame retardant parts of products that contain 0.1 per cent by weight or more of decabromodiphenyl ether (CAS No. 1163-19-5). The use of decabromodiphenyl ether in electrical and electronic products is regulated by chapter 2a. 2a-3 Restricted substances in EEE It is prohibited to produce, import, export and make available on the market EEE in which the content of lead, mercury, hexavalent chromium, polybrominated biphenyls (PBBs) or polybrominated diphenyl ethers (PBDEs) in homogeneous materials exceeds 0.1 per cent by weight or of cadmium exceeds 0.01 per cent by weight. Homogeneous material means one material of uniform composition throughout or a material, consisting of a combination of materials that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes. For EEE in following categories the restriction of substances shall apply from: a) Category 8 and 9: 22 July 2014 b) Category 8 in vitro diagnostic medical devices: 22 July 2016 c) Category 9 industrial monitoring and control instruments: 22 July 2017 d) EEE that have not previously been regulated and are not covered by a) to c): 22 July 2019. Use or uses that remain allowed: 2-7. Brominated flame retardants The prohibitions in the first and second paragraph do not apply if the substance is used in a) vehicles that are approved under the currently prevailing version of the regulations of 4 October 1994 No. 918 regarding technical requirements and approval of vehicles, parts and equipment, b) aircraft registered in the Aircraft Register pursuant to Act of 11 June 1993 No. 101 relating to aviation, c) vessels registered in the Shipping Register pursuant to the Norwegian Maritime Code of 24 June 1994 No. 39 or the Norwegian International Ship Register pursuant to Act of 12 June 1987 No. 48 relating to the Norwegian International Ship Register or d) rolling stock for use on railways, including tramways, underground railways, suburban lines and similar forms of rail transport. 2a-3 Restricted substances in EEE The restriction of substances does not apply to applications listed in Appendix 1 and 2. Exemptions for EEE in category 1-7, 10 and 11 are valid for up to five years, and category 8 and 9 up to seven years. The restriction of substances does not apply to reused spare parts, recovered from EEE placed on the EEA market before 1 July 2006 and used in equipment placed on the EEA market before 1 July 2016, provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of parts is notified to the consumer. The importer and the distributor shall notify all previous sales personnel and the Norwegian Environment Agency if they believe or have reason to believe that an EEE does not comply with the requirement in the first paragraph. 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 decabromodiphenyl ether in pure form, in preparations, in products, and in parts of products containing greater than or equal to 0,1 % by weight of decabromodiphenyl ether. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: On the basis of a general concern over the use of brominated flame retardants (BFR), a national action plan was set up by the Norwegian authorities in 2002 (later updated in 2009) focusing on five priority substances including c-decaBDE. BFRs, including c-decaBDE, were also officially included in the national goal for substantially reducing emission of certain hazardous substances by 2020 as described in a white paper to the parliament (Ministry of Environment, Norway, 2003). Norwegian monitoring data show detectable levels in several environmental compartments. High concentrations of BDE209 the main component of decaBDE, is detected at some locations. In sediments and water BDE209 is the domination PBDE congener. BDE209 is also detected in biota (mussels and fish) and in leakage from landfills (TA-2006). BDE209 is also present in terrestrial environment; moss samples from locations covering Norway from north to south, west to east reveal that BDE209 is the predominant congener. BDE209 was also present in moose (Mariussen et al., 2008). PBDE exposure through food and the resulting serum levels have been investigated in Norway. In food samples analyzed for BDE209 high levels were found in eggs, vegetable oil, ice cream and biscuits, while the highest amounts were found in dairy products, which include milk, cheese, and butter. The calculated exposure to BDE209 was 1.5 (mean) and 1.4 (median) ng/kg bw per day, which is higher than the exposure to SPBDEs of other PBDE. Results indicate that intake of BDE209 and SPBDEs have different dietary sources and that dairy products proved to be the most important dietary source of BDE209 exposure. Serum levels of BDE209 were not analyzed in these samples (Knutsen et al., 2008). Thomsen et al. 2007 found high levels of BDE209 (10 ng / g lipid) in pooled serum samples from Norwegian humans. A similar study detected an average of 2.26 ng / g lipid in plasma from pregnant women from the Bod region (TA-2303). The reason for this large difference in BDE 209 levels is not known. Thomsen et al. have previously reported BDE209 as the dominant congener of PBDE congeners analyzed and this was also confirmed in the study of women from Bod. These results are much higher than found in a similar study on blood plasma from Swedish men. The above information is summarized in (TA-2303). Household dust and occupational exposure is thought to be the main sources for exposure to BDE-209 and other congeners present in c-decaBDE. Toddlers and infants have a higher daily intake of dust and dairy products than adults, and higher serum levels of BDE209 have been found in children less than 5 years compared to their parents. PBDE congener composition was also different in the children compared to their parents indicating possible debromination to more bioaccumulative and toxic congeners (US EPA 2010). Some professions are exposed to higher decaBDE than the average population and other workers. Foam recycling workers, carpet installer and PC technicians are reported to have higher serum levels of BDE209 than control groups. In a Swedish study employees at a recycling plant and rubber mixers had higher levels of BDE209 in serum than control. Samples taken during and after 5 weeks of vacation revealed that BDE-209 and other highly brominated PBDE congeners had lower half-life than the lower brominated congeners. (US EPA 2010). In animal studies of amphibian, fish and rodents exposed to BDE209 at vulnerable stages such as the developmental phase, effects on hormonal axis as the thyroid and steroid is of concern (EU RAR 2004, 2007 and 2012, UK EA 2007, UNEP/POPS/POPRC.9.2). Although the toxicology data of BDE209 is ambiguous, some studies indicate negative effect on neurological development at low doses. Norwegian authorities banned decaBDE based on its potential PBT properties and the general concern about the ubiquitous presence and increase of decaBDE in the environment including the Norwegian Arctic and a concern for presence of decaBDE in human matrices and human health. The concern for increased levels of persistent PBDEs due to continuously debromination from the pool of decaBDE in the environment. 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 decaBDE gives rise to concern for long term effects in the environment. In Norway BDE209 has been investigated and detected in a number of studies. Furthermore BDE209 has been found in various environmental compartments in the Arctic, including the Norwegian Arctic, and can undergo long-range environmental transport (Hermanson et al., 2010, Environment Canada 2010a, Mariussen et al. 2008). Norwegian monitoring data shows that BDE209 deposited to the Arctic environment is bioavailable to the organisms living there and that BDE-209 is widespread in Arctic food webs (de Wit et al 2006, 2010). Norwegian environmental monitoring studies investigating congener pattern and levels of PBDEs in eggs and plasma of glaucous gulls breeding at Bjrnya in the Arctic revealed detectable levels of BDE209 in bird plasma comparable to levels found in liver samples of birds located at more southern parts of Europe (TA-2006). Similar results were reported in liver samples from glaucous gulls from Svalbard (RAR update, 2004). The concerns about occurrence of decaBDE in the environment have now been further strengthened. These recent studies from the Arctic document the occurrence of decaBDE in birds from remote areas in the Arctic. In Norway, high levels of BDE209 were detected in sediments and BDE209 represented up to 90% of SPBDEs (TA-2252). A study conducted in Lake Mjsa in the Southern part of Norway revealed that BDE209 was the dominant congener (50-90%) in sediments and waste water in many areas (TA-2104). DecaBDE (BDE-209) dominates completely in all sediment samples, representing more than 97% of SPBDE all sediment sites in sefjorden and surrounding areas in the western part of Norway. PBDEs are also found in the lower trophic levels of the food chain in sefjorden (TA-2146). The interquartile range of SPBDE in sediments sludge from landfills and sewage sludge treatment plants was 3-800 ng/g d.w. (dry weight), with the highest concentrations in sewage sludge. BDE-209 was the dominating congener, but BDE-47 and BDE-99 were also found in relatively high proportions. Furthermore, in all marine sediment samples BDE-209 were the most dominant congeners and for 7 of the samples BDE-209 represented more than 90% of SPBDE (TA-2096). Sediment samples from outside a marina downstream (Muusya, close of the city of Drammen, southern Norway) showed significantly elevated concentrations with a high percentage of BDE-209. In all the fish samples from the inner Drammensfjord was BDE-209 detected. The concentrations were in general low (0.1-20% of SPBDE), but the results are in accordance with new knowledge about BDE-209 as a bioavailable substance (TA-2051). BDE209 is also detected in aquatic biota such as mussels, fish and in leakage from landfills (TA-2006). BDE209 is also present in terrestrial environment; moss samples from locations covering Norway from north to south, west to east reveal that BDE209 is the predominant congener. DecaBDE was also present in moose and lynx (Mariussen et al., 2008). In animal studies of amphibian, fish and rodents exposed to BDE209 at vulnerable stages as the developmental phase, effects on hormonal axis as the thyroid and steroid is of concern. Although the toxicology data of BDE209 is ambiguous, some studies indicate negative effect on neurological development at low doses. The general concern about the ubiquitous presence and increase of decaBDE in the environment and the concern for increased levels of persistent PBDEs due to continuously debromination from the pool of decaBDE in the environment, together with the risk for endocrine disrupting effects of the mix of PBDE congeners to organisms at vulnerable stages, led Norwegian authorities to ban further use of decaBDE. 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: 01/07/2013 Date of entry into force of the final regulatory action: 01.04.2008 amended 01.07.2013. |