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Canada - Final Regulatory Action
Octabromodiphenyl ether CAS number:
32536-52-0
Date circular:
12/12/2010

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:

The manufacture, use, sale, offer for sale or importation is prohibited

Polybrominated diphenyl ethers (PBDEs) are a group of chemical flame retardants that slow the ignition and spread of fire. In general, plastics are the primary end use for flame retardants due to the inherent flammability of many polymers. As such, PBDEs can be found in many items such as building and automobile materials, carpet underlay, furniture foam and electronic equipment.

OctaBDE was predominantly used in acrylonitrile butadiene styrene to flame retard business equipment housings.

Use or uses that remain allowed:

The regulations do not apply to PBDEs that are contained in a pest control product within the meaning of subsection 2(1) of the Pest Control Products Act.

The regulations do not apply to PBDEs, or to any resin, polymer or other mixture containing a PBDE, that is for use

(a) in a laboratory for analysis;

(b) in scientific research; or

(c) as a laboratory analytical standard.

The regulations do not apply to a product that is formed into a specific physical shape or design during its manufacture and that has, for its final use, a function or functions dependent in whole or in part on its shape or design, if that product contains a PBDE.

The regulations do not apply to any PBDE that is present as a contaminant in a chemical feedstock used in a process from which there are no releases of the PBDE, provided that the PBDE is destroyed or completely converted in that process to a substance that is not a PBDE.

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

Summary of the final regulatory action:

The Polybrominated Diphenyl Ethers Regulations: a) prohibit the manufacture of PBDEs in Canada (tetraBDE, pentaBDE, hexaBDE, heptaBDE, octaBDE, nonaBDE and decaBDE congeners); and b) prohibit the use, sale, offer for sale and import of those PBDEs that meet the criteria for virtual elimination under CEPA 1999 (tetraBDE, pentaBDE and hexaBDE congeners), as well as mixtures, polymers and resins containing these substances.

Commercial Mixtures PBDE Congener Groups tetraBDE pentaBDE hexaBDE heptaBDE octaBDE nonaBDE decaBDE OctaBDE -0.5% 12% 45%33%10%0.7%PBDE congeners targeted for virtual elimination in bold The OctaBDE commercial mixture is prohibited for manufacture, use, sale, offer for sale, and import due to the presence of pentaBDE and hexaBDE congeners.

The reasons for the final regulatory action were relevant to: Environment

Summary of known hazards and risks to the environment:

The Canadian Environmental Protection Act, 1999 (CEPA 1999) requires the Minister of the Environment and the Minister of Health to conduct screening assessments of substances that meet the categorization criteria set out in the Act and Regulations to determine, in an expeditious manner, whether substances present or may present a risk to the environment or to human health. Based on the results of a screening assessment, the Ministers can propose taking no further action with respect to the substance, adding the substance to the Priority Substances List (PSL) for further assessment, or recommending that the substance be added to Schedule 1 of CEPA 1999 and, where applicable, the implementation of virtual elimination.

A screening assessment involves an analysis of a substance using conservative assumptions to determine whether the substance meets the criteria as defined in section 64 of CEPA 1999. This ecological screening assessment examines various supporting information and develops conclusions based on a weight of evidence approach as required under Section 76.1 of CEPA 1999. The screening assessment does not represent an exhaustive review of all available data; rather, it presents the most critical studies and lines of evidence supporting the conclusions. One line of evidence includes consideration of risk quotients to identify potential for ecological effects. However, other concerns that affect current or potential risk, such as persistence, bioaccumulation, chemical transformation and trends in ambient concentrations, are also examined in this report.

Seven polybrominated diphenyl ethers (PBDEs) were identified in a pilot project list of 123 substances for screening assessment under CEPA 1999, on the basis of their potential persistence and/or bioaccumulation in the environment and inherent toxicity to organisms.

Data relevant to the ecological screening assessment of PBDEs were identified in original literature, review documents, and commercial and government databases and indices. In addition to retrieving the references from a literature database search, direct contacts were made with researchers, academics, industry and other government agencies to obtain relevant information on PBDEs. Ongoing scans were conducted of the open literature, conference proceedings and the Internet for relevant PBDE information. Information obtained as of October 2004 was considered for inclusion into this document, while that received between November 2004 and October 2005 was reviewed, but not generally added. The information obtained between November 2004 and October 2005 was found to support the conclusions of this report determined with information received up to October 2004. In addition, an industry survey on PBDEs was conducted for the year 2000 through a Canada Gazette Notice issued pursuant to Section 71 of CEPA 1999. This survey collected data on the Canadian manufacture, import, uses and releases of PBDEs (Environment Canada 2003). Toxicological studies were also submitted by industry under Section 70 of CEPA 1999.

Environment Canada's Ecological Screening Assessment Report indicated that the greatest potential risks from PBDEs in the Canadian environment are the secondary poisoning of wildlife from the consumption of prey containing elevated concentrations of PBDEs, and effects on benthic organisms, which may result from elevated concentrations of certain PBDE congeners in sediments.

The 2006 screening assessment report also concluded that PBDEs are entering the environment in a quantity or concentration, or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity. More specifically, it concluded that tetraBDE, pentaBDE and hexaBDE congeners meet the criteria for persistence and bioaccumulation, as defined by the Persistence and Bioaccumulation Regulations of CEPA 1999. The screening assessment also concluded that their presence in the environment results primarily from human activity (that is, releases from product manufacturing and processing, and throughout the product life cycle). As a result, tetraBDE, pentaBDE and hexaBDE congeners meet the conditions for virtual elimination, as set out in subsection 77(3) of CEPA 1999.

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

Environment Canada's survey identified that PentaBDE and Octabromodiphenyl ether Commercial Mixture (OctaBDE) were used in Canada in 2000. Significant reformulation activity has occurred in recent years related to PentaBDE and OctaBDE. All companies that reported uses of PentaBDE and OctaBDE in 2000 have reported complete phase-out since 2005. This reformulation activity was strongly driven by customer demands for PBDE-free products, and the fact that PentaBDE and OctaBDE were largely not available for purchase beyond 2005 due to the phase-out of production by the only manufacturer in the United States. Some previous users of OctaBDE in Acrylonitrile butadiene styrene (ABS) compounding have also ceased compounding activities in Canada. In addition, OctaBDE was already a very small volume flame retardant with shrinking usage before 2004, as the uses of ABS in electronics have been replaced by other resins and resin blends [e.g. polycarbonate (PC)/ABS blends and polystyrene (PS)] in which OctaBDE is not used.

Since there is no manufacture of any form of PBDEs in Canada, and the commercial use of tetraBDE, pentaBDE and hexaBDE congeners have been phased out internationally and in Canada since 2006, the regulations constitute a preventative approach to ensure that these activities are not introduced in Canada.

Date of entry into force of the final regulatory action: 19/06/2008