Chemical name: Cyclododecane, 1,2,5,6,9,10-hexabromo-, Cyclododecane, hexabromo-

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:

n.a.

It is prohibited to manufacture, import, export, placing on the market and use substances that contain 0.01 per cent by weight or more of hexabromocyclododecane (CAS number 25637-99-4, 3194-55-6, 134237-50-6, 134237-51-7, 134237-52-8).

It is prohibited to manufacture, import, export and make available on the market products or flame retarded parts of products that contain 0.01 per cent by weight or more of hexabromocyclododecane (CAS number 25637-99-4, 3194-55-6, 134237-50-6, 134237-51-7, 134237-52-8).

Use or uses that remain allowed:

The use of hexabromocyclododecane, whether on its own or in preparations, in the production of expanded polystyrene articles, and the production and placing on the market of hexabromocyclododecane for such use, shall be allowed provided that such use has been authorised in accordance with Title VII of Regulation (EC) No 1907/2006 of the European Parliament and of the Council(*), or is the subject of an application for authorisation submitted by 21 February 2014 where a decision on that application has yet to be taken.

The placing on the market and use of hexabromocyclododecane, whether on its own or in preparations, in accordance with this paragraph shall only be allowed until 26 November 2019 or, if earlier, the date of expiry of the review period specified in an authorisation decision or the date of withdrawal of that authorisation pursuant to Title VII of Regulation (EC) No 1907/2006.

Pesticide use or uses that remain allowed:

n.a.

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

Summary of the final regulatory action:

Regulations to restrict production, import, export or sale of consumer products that contain HBCDD exciding certain limit values.

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

Summary of known hazards and risks to human health:

HBCDD is used in several products, some of which are available to consumer, e.g. textiles in furniture, automobile interior textiles, construction boards, and mattress ticking. In most applications HBCDD is present as non-bound within a polymer, and may migrate from the polymer and be released.

Consumers may be exposed to HBCDD by dermal, oral and respiratory rout.

HBCDD has been detected in breast milk and plasma from Norwegian mothers. In 1986, 1993 and 2001, Norwegian breast milk samples from were obtained from 10-12 primiparous mothers living in a coastal area in the North (Tromsø), in a rural inland area (Hamar), and in an industrialized area in the South Norway (Skin/Porsgrunn). Samples collected in 1993 and 2001 in Tromsø, Hamar and Skien/Porsgrunn were pooled. From the 1986 study, only two individual samples from Tromsø were available. HBCDD was found in all samples, but at very varying levels, range 0.25-2 ng/g lipids. (Thomsen et al., 2003). HBCDD levels in plasma from 10 pregnant women living in Bodø, Norway and from 10 women living in Taimyr, Russia were analysed by LC-MS. The samples were collected in August-December 2002. The women's ages were 20-35 and they had all giving birth to one child before. None of the locations had any known local HBCDD source. HBCDD was detected in more than half of the samples but at low concentrations, close to the limit of detection. The Norwegian samples median and range values were (pg/ml plasma): a-HBCDD 19 (11-345), ß-HBCDD 7 (5-343), ?-HBCDD 23 (7-317) and the Russian samples median and range values were: a-HBCDD 21(11-51), ß-HBCDD 8 (5-126), ?-HBCDD 33 (13- 160). (Odland et al., 2005).

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

Reduced exposure levels to HBCD.

Summary of known hazards and risks to the environment:

HBCDD is persistent in the environment and bioaccumulates. It has been detected widespread in the Norwegian environment in both remote and urban/suburban arias. Concerns are linked to the degree of bioaccumulation in several food chains and for Arctic organisms, in particular, which are affected by multiple stressors due to climate changes and high body burden of several pollutants.

HBCDD has been detected in effluent water and sludge in urban STPs in Norway. The concentration detected in the effluent water ranged from about 0.0005 µg HBCDD/l from Bekkelaget to about 0.025 µg HBCDD/l from Høvringen. The concentrations in sludge ranged from parts of µg HBCDD/kg dwt at Bekkelaget to about fifty in sludge from Høvringen (Fjeld et al., 2005). The authors also analysed leachate water and sludge from landfills. The concentrations of HBCDD in untreated leachate water, and sludge ranged from 0.00036-0.149 µg HBCDD/l, and 0.16-9.95 µg HBCDD/kg dwt. The highest concentrations were measured at the Djupvik landfill. The concentration in the rinsed sample was 34-67 % of that in the untreated water samples (Fjeld and co-workers, 2005).

A screening of the occurrence of HBCDD in the Norwegian environment was performed by Fjeld et al. (2005). Sediment samples were taken from the freshwater environment from 6 localities in the southern Norway. From each sampling station 5-8 samples were taken from the upper layer 0-2 cm. Fjeld and co-workers (2006b) measured HBCDD in surface sediments in Lake Mjøsa in Norway. Elevated concentrations of HBCDD (8-21 µg HBCDD/kg dwt) were found outside of the town of Lillehammer and the Vingrom station, as compared to the commonly found levels (0.5-2 µg HBCDD/kg dwt). These elevated concentrations were considered to reflect that a textile factory in Lillehammer used HBCDD in their production in recent years. Only slightly elevated concentrations (2-6.5 µg HBCDD/kg dwt) were found at a few other urban sediment stations. The dated sediment core at the Vingrom station showed an evident increase in the HBCDD concentration from the late 1990s, with a maximum level in the surface layer. The other dated cores showed only a small increase in the HBCDD concentration towards the sediment surface. Schlabach et al. (2002) measured HBCDD in sedimentation basins for leachate waters from six landfills in southern Norway. The concentrations ranged from below the detection limit in Drammen to 84 ng HBCDD/kg wwt in the landfill from Kristiansand. Sediment samples from the Drammens River had detectable concentrations of a-HBCDD and ?-HBCDD (Schlabach et al., 2004). Surprisingly high concentrations of approx. 8000 µg HBCDD/kg dwt have been detected in the Norwegian Åsnefjord, which receives waste water from e.g. an EPS formulator.

HBCDD has also been found in the biota in Norway. Fjeld and co-workers (2005) sampled mussels along the Norwegian coast and in Norwegian fjords. Most values ranged from about 0.2-2.3 µg HBCDD/kg wwt. However, concentrations from 55-329 µg HBCDD/kg wwt were detected in the Åsne fjord, where a manufacturer of EPS beads is situated.

Fjeld (2006a) reported concentrations of HBCDD in European smelt (Osmerus eperlanus), Vendace (Coregonus albula), and Brown Trout (Salmo trutta trutta) from lake Mjösa in Norway. European smelt and Vendace are important preyfish for the trout. The concentrations detected in 2005 were 466 µg HBCDD/kg lwt (8.8 µg HBCDD/kg wwt), 374 µg HBCDD/kg lwt (10.7 µg HBCDD/kg wwt), 729 µg HBCDD/kg lwt (18 µg HBCDD/kg wwt) for the European smelt, the Vendace, and the Brown trout, respectively.

HBCDD is also transported with air and particles, and has been detected in moss (Hylocomium splendens) in Norway. The highest concentrations were detected on the south-southwest coast, and in general decreased from south to north. The concentrations detected span almost four orders of magnitude from below the limit of detection to 11114 µg HBCDD/kg wwt.

Murvoll and co-workers (2006) analysed yolk sac from newly hatched chicks of the European shag from the island Sklinna, 50 km of the coast of mid-Norway. HBCDD was detected in all specimens, with a mean concentration of 29 µg HBCDD/kg wwt, or 417 µg HBCDD/kg lwt. The concentration of HBCDD was higher than any of the PBDE congener.

Furthermore, HBCDD has been detected in remote areas as the Arctic. HBCDD has been measured in sediment in lake Ellasjøen at the arctic Bear Island, north of Norway (Christensen et al., 2004). The a- and ?- diastereomers of HBCDD were detected in sediment at 1-2 cm depth, i.e. from the period 1973-1987. HBCDD was not found in the layers from the period 1987-2001 nor from the period 1934-1973. The ß- diastereomer was not at all found.

Jenssen et al. (2004) measured brominated flame retardants (including HBCDD) in the arctic marine food web in the Svalbard area in the North-Atlantic. The concentration of HBCDD increased with increasing trophic level, except for the polar bear which may indicate a capability of metabolising the substance for the polar bear. No HBCDD was detected in the lower pelagic zooplankton species Calanus glacialis, Thysanoessa inermis, and Parrratemisto libellula. The levels detected in polar cod, ringed seal, and polar bear ranged from 5-25 µg HBCDD/kg lwt, 15-35 µg HBCDD/kg lwt, and 5-15 µg HBCDD/kg lwt, respectively. Gabrielsen et al. (2004) measured halogenated organic contaminants, including HBCDD, in adipose tissue of Polar Bears from Svalbard north of Norway in the arctic region. The arithmetic mean value was 25.6 µg HBCDD/kg wwt, with a range of 9.7-45 µg HBCDD/kg wwt (all of the 15 measurements were above the limit of detection).

Temporal trends:

Knudsen et al. (2005) analysed eggs from Atlantic puffins, Herring gull, and Kittywake from northern Norway (Hornøya and Røst) from 1983, 1993, and 2003. The HBCDD levels have increased with a factor about 5-8 over 20 years from 1.1-2.9µg/kg wwt 1983 to 6.1-17 µg/kg wwt 2003.

Bytingsvik and co-workers (2004) reported a temporal trend for HBCDD in Atlantic cod (liver) caught at the estuary of river Glomma, as the concentration increased significantly, 8 or 3-4 times from 1998 to 2003, when expressed on a wwt or lwt basis, respectively.

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

Reduced levels of HBCDD in the Norwegian environment and thus reduced risk of adverse effect on the wildlife.

Date of entry into force of the final regulatory action: 09/07/2016