Subject: Notification of the addition of waste containing three brominated flame retardants to the Norwegian hazardous waste list

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1 DET KONGELIGE MILJ0VERNDEPARTEMENT Royal Ministry of the Environment EFTA Surveillance Authority Rue Belliard 35 B-1040 Brussels Belgium : Your ref Our ref Date Case no: AUG 2011 Dear Madam/Sir, -' ' ;K'" Subject: Notification of the addition of waste containing three brominated flame retardants to the Norwegian hazardous waste list Reference is made to the Authority's letter of 6 May 2011 regarding the complaint against Norway concerning the classification of waste, and the invitation to Norway to submit information and to notify the classification of waste containing five brominated flame retardants 1 as hazardous waste. Reference is also made to the communication between the Authority and the Ministry following the Authority's letter, including the Ministry's letter of 14 June 2011 regarding the Norwegian regime applicable to hazardous waste. In an amendment of the Norwegian regulation on hazardous waste adopted in December 2002, waste containing the five brominated flame retardants was added to the Norwegian hazardous waste list. The amended waste list entered into force 1 January According to Article 1(4) of Directive 91/689/EEC on hazardous waste, the Ministry hereby notifies the classification of waste containing the three brominated flame 1 Pentabromodiphenyl ether (PentaBDE) Octabromodiphenyl ether (OctaBDE) Decabromodiphenyl ether (DecaBDE) Tetrabromobisphenol A (TBBPA) Hexabromocyclododecane (HBCDD) Postal address PO Box 8013 Dep 0030 Oslo Office address Myntgt 2 postmottak@md.dep.no Telephone Vat no Department for Climate Change and Pollution Control Telefax Our officertherese Aasen

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3 retardants Octabromodiphenyl ether (OctaBDE), Decabromodiphenyl ether (DecaBDE) and Hexabromocyclododecane (HBCDD) as hazardous waste in Annex 3 to Chapter 11 of the Norwegian Waste Regulation. As mentioned in the Ministry's letter of 14 June 2011, the limit values in Part B of Annex 3 for the brominated flame retardants Pentabromodiphenyl ether (PentaBDE) and Tetrabromobisphenol A (TBBPA), are equivalent to the general limit values in Part A of Annex 3 (general concentration limits). Consequently, these two substances are not covered by this notification. Please find enclosed a summary of the data and analysis relating to the assessment of why and on which basis Norway considers that waste containing each of the five brominated flame retardants displays properties listed in Annex III to Directive 91/689/EEC on hazardous waste. The summary also includes a justification of the concentration limits for the five substances. The summary includes the analysis for all five brominated flame retardants covered by the complaint, although the notification only covers three of them. Please note that we have used the references to the former waste regulations, ie Directive 91/689/EEC on hazardous waste, now incorporated in the Waste Framework Directive (Directive 2008/98/EC), although the Waste Framework Directive was implemented in the Agreement on the European Economic Area (EEA) as of 1 July Yours sincerely, [enrik Eriksen ( Acting Deputy Director General Therese Aaseh Adviser Enclosure 1 Page 2

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5 Basis for the Norwegian classification of waste containing brominated flame retardants as hazardous waste Classification of waste containing more than 0,25 % of any of the five substances pentabde, octabde, decabde, HBCDD and TBBPA as hazardous waste was introduced in the waste regulations in Norway to ensure sound management of such waste, contributing to lower emissions to the environment. The five brominated flame retardants are included in the national priority list of the most hazardous substances causing particularly serious health and environmental concerns in Norway. Norway has a national goal to eliminate the use and emissions of these substances by The substances are found widespread in the environment in Norway, and in the Arctic - inter alia in sediments, fish and birds, and pose a threat to the environment due to their hazardous properties. Norway considers that the substances display properties listed in Annex III to Council Directive 91/689/EEC of December 1991 on hazardous waste, namely HI 4 "Ecotoxic": Substances and preparations which present immediate or delayed risks for one or more sectors of the environment. Therefore, waste containing more than 0,25 % of these substances are classified as hazardous waste. PentaBDE and TBBPA are classified with the standard phrases N:R50/53: very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment according to Directive 67/548 EEC on classification and labeling of hazardous substances. This implies that waste containing more than 0,25% of pentabde or TBBPA is classified as hazardous waste also according to the general criteria of the waste regulation (Annex 3, part A of the Norwegian waste regulation). The brominated flame retardants octabde, decabde and HBCDD display similar properties, and Norway therefore considers the risk from waste containing these substances to the health and environment to be similar in magnitude. The concentration limit for classification of waste containing these substances are therefore also 0,25% in the waste regulations. Documentation concerning each of the substances is provided below. Please also find attached at the end of the document, references to reports from the Arctic Monitoring and Assessment Programme and the Norwegian Climate and Pollution Agency concerning brominated flame retardants in Norway and in the Arctic. These reports document extensive occurrence of these substances in the Arctic, far away from the sources of the pollution. Substance specific information on the 3 bromatedflame retardant substances that are not in line with the general limit values in Part A of Annex 3 in the Norwegian waste regulation: HBCDD ((hexabromocyclododecane) and all major diastereoisomers (alpha-, beta- and gamma-hbcddv): HBCDD is considered to be toxic for the aquatic environment, and new findings support the toxic potential in mammals and birds. HBCDD has been found to have a widespread occurrence in the environment. It is also found to accumulate and biomagnify in the food webs and is persistent in the environment. There are findings of increasing levels in humans 1 Substances classified with R50/53 are ecotoxic and fulfills the criteria H14 "Ecotoxic" in Directive 91/689/EEC

6 and in remote regions. A large part of the emissions is diffuse and not controlled. Recent reports from the Arctic Monitoring and Assessment Programme (AMAP) highlight HBCDD as a substance of concern in the Arctic region based on its long range transport, persistence, toxicity for the aquatic life, birds and mammals, bioaccumulation in biota and humans, and increasing levels and trends in humans, biota and environment (AMAP 2009). HBCDD is regulated in the REACH regulation. In 2008 HBCDD was identified as a Substance of Very High Concern (SVHC) since it meets the PBT criteria. HBCDD was included in the Candidate List, see background document for HBCDD, cf. process/candidate list table en.asp. In 2011 HBCDD was adopted to be included in the list of substances subject to authorization (Annex XIV) in REACH. HBCDD meets the criteria for authorization since it has PBT properties, is in wide dispersive use and in high volumes. Authorization implies that manufacturers, importers and downstream users shall not place HBCDD on the marked or use the substance himself unless the use(s) of HBCDD on its own, in a mixture or the incorporation of the substance in an article has been authorized. The obligation applies to HBCDD in a concentration of 0.1 % (w/w) or more. The latest application date for HBCDD is 21 February An authorization can only be granted for HBCDD if it is shown that socioeconomic benefits outweigh the risks to human health or the environment arising from the uses of the substance, and if there is no suitable alternative substances or technologies. HBCDD is furthermore concluded to be a persistent organic pollutant (POP) according to the criteria in the Protocol on Persistent Organic Pollutants under the 1979 Convention on Long Range Transboundary Air Pollution, and in the global Stockholm Convention on Persistent Organic Pollutants. The concentration limit for HBCDD in hazardous waste is expected to be in the same order of magnitude as the concentration limits that are planned adopted for pentabde and octabde in the EU POP regulation (see below). For HBCDD there is no harmonized classification in EU yet. However a recommendation for agreed classification exists: Xn; R62 (Possible risk of impaired fertility), R 63 (Possible risk of harm to the unborn child), R64 (May cause harm to breastfed babies). Octabromodiphenyl ether (octabde): Based on the EU risk assessment performed under the Council Regulation No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances, restrictions on the marketing and use of octabde were introduced under Directive 2003/11/EC. This regulation is now included in the REACH regulation (Annex XVII). Manufacture, import, export, placing on the marked and use of octabde on its own, in mixtures and in articles is prohibited when the concentration of octabde is 0.1 % (w/w) or more. The PBT assessment under the existing chemicals regulation 793/93, concluded that octabde fulfils the PBT criteria, cf. OctaBDE is included in the EU regulation of Persistent Organic Pollutants (POP), in the Protocol on POPs under the Convention on Long Range Transboundary Air Pollution and in the Stockholm Convention on Persistent Organic Pollutants. EU has started a revision of the 2 PBT: Persistent, Bioaccumulative, Toxic. It should be noted that the criteria for defining a substance as PBT is more strict than the criteria for classification of 50/53. It has to be more persistent, more bioaccumulative and more toxic in order to fulfill the PBT criteria.

7 POP regulation and a strict concentration limit for classification as hazardous waste is proposed for octabde. The revision is estimated to be adopted within The proposed strict concentration limit for the commercial mixture of OctaBDE (50 ppm or 1500 ppm) is considerably lower than the Norwegian concentration limit on hazardous waste (2500 ppm). OctaBDE is classified in the CLP regulation (Classification, labelling and packaging of substances and mixtures) annex VI, table 3.2 (the list of harmonized classification and labeling of hazardous substances from annex I to Directive 67/548/EEC) with the following risk phrases: May cause harm to the unborn child (T; R61) Possible risk of impaired fertility (Xn; R62) According to Directive 67/548/EEC, the concentration limits for classification are 0.5 % for R61 and5%forr62. Decabromodiphenyl ether (decabde) DecaBDE is a chemical of concern due to its occurrence in human blood and breast milk in the general population, the widespread contamination in the environment, its potential hazardous properties and the fact that it can be degraded in the environment and in living organisms and may transform to PBT- or vpvb-substanses. Norway is particularly alarmed by the fact that there is evidence of occurrence of DecaBDE in the Arctic, including in top predators. In an updated UK assessment of the EU risk assessment it is stated that decabde has the potential to degrade into a number of dangerous and polluting chemicals, including some which have been added to the Stockholm Convention on Persistent Organic Pollutants (POP), cf. The latest evidence suggests that detection of hazardous degradation products (hexabde and heptabde 3 ) in sediment, sewage sludge and biota may be linked to emissions of decabde, although it is still difficult to estimate the rates and amounts of formation, cf. EU has no general prohibition of decabde, however decabde is regulated in the RoHS- directive. The directive prohibits electric and electronic articles containing decabde in concentrations from 0.1 % (w/w) or more. Norway has in addition a national general regulation of decabde related to restrictions on the manufacture, import, export, sale and use of chemicals and other products hazardous to health and the environment (Product Regulations). According to this regulation, manufacture, import, export, placing on the marked and use of decabde on its own, in mixtures and in articles is prohibited when the concentration of decabde is 0.1 % (w/w) or more. Some exceptions exist for use of decabde in cars, boats, aeroplanes, etc. For decabde there is no harmonized classification in EU. Substance specific information on the 2 bromatedflame retardant substances that are in line with the general limit values in Part A of Annex 3 in the waste regulation: 3 HexaBDE congeners which themselves have very persistent and very bioaccumulative properties, and heptabde which has recently been added to the Stockholm Convention on persistent organic pollutants (POPs).

8 Pentabromodiphenyl ether (pentabde): PentaBDE is classified in the CLP regulation annex VI, table 3.2 (the list of harmonized classification and labeling of hazardous substances from annex I to Directive 67/548/EEC) with the following risk phrases: Harmful: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed (Xn; R48/21 /22), May cause harm to breastfed babies (R64), and Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment (N; R50/53). According to Directive 67/548/EEC on classification and labeling of hazardous substances the concentration limits for classification are 10 % for R48/21/22, 1 % for R64 and 0.25 % for R50/53. In Annex XVII of the REACH regulation, manufacture, import, export, placing on the marked and use of pentabde on its own, in mixtures and in articles is prohibited when the concentration of pentabde is 0.1 % (w/w) or more. PentaBDE is included in the EU regulation on Persistent Organic Pollutants (POP), in the Long Range Transport Convention and in the Stockholm Convention. EU has started a revision of the POP regulation, and a strict concentration limit for classification as hazardous waste is proposed for pentabde. The revision is estimated to be adopted within The proposed strict concentration limit for the commercial mixture of PentaBDE (20 ppm or 500 ppm) and the congener Penta-BDE (10 ppm or 200 ppm) are considerably lower than the Norwegian concentration limit on hazardous waste (2500 ppm). Tetrabromobisphenol A (TBBPA) TBBPA is classified in the 1. ATP to the CLP regulation annex VI, table 3.2 (the list of harmonized classification and labeling of hazardous substances from annex I to Directive 67/548/EEC) with the following risk phrases: Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment (N; R50/53). According to Directive 67/548/EEC on classification and labeling of hazardous substances the concentration limits for classification as R50/53 is 0.25 %. In an EU risk assessment on TBBPA local risks were identified (tetrabromobisphenol-a; 2,2',6,6'-tetrabromo-4,4'-isopropyliden-diphenol EU Risk Assessment Report (UK rapporteur), ec.europa.eu/index.php?pgm=ora). Under certain conditions TBBPA may degrade to bisphenol A, which is documented to have serious environmental effects. In an updated EU risk assessment on bisphenol A uncertainties still exist on low dose effects of bisphenol A on snail and fish (Bisphenol A (4,4'- isopropylidene-diphenol), CAS No , EU Risk Assessment Report (UK rapporteur), data/transit measures/annex xv transreports en.asp).

9 References: Reports from the Arctic Monitoring and Assessment Programme: AMAP Assessment 2009: Human Health in the Arctic (see link on AMAP website ( ( cfm?action=getfile&dirsub=&filename=human%5fhealthnear%5ffinal7.pdf&sort=default) AMAP Assessment 2009: Persistent Organic Pollutants in the Arctic. Science of the Total Environment Special Issue. 408: Elsevier, Persistent Organic Pollutants (POPs) Report. AMAP, AMAP Assessment 2002: Persistent Organic Pollutants in the Arctic. Arctic Monitoring and Assessment Programme (AMAP), Oslo, Norway. xvi+310pp Reports from the Norwegian Climate and Pollution Agency: Kartlegging av bromerte flammehemmere og klorerte parafmer (2003) Occurrence of selected organic micropollutants and silver at wastewater treatment plants in Norway (2011) Miljogifter i flsk og Zooplankton i MJ0sa, Screening of selected priority substances of the Water Framework Directive in marine samples miliogifter/rapporter/screening-of-selected-prioritv-substances-of-the-water-framework- Directive-in-marine-samples / Analyse av sedimenter: Kildesporing av bromerte flammehemmere i Älesundsomrädet (2008) miliogifter/rapporter/analvse-av-sedimenter-kildesporing-av-bromerte-flammehemmere-i- Alesundsomradet/

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