rohs annex ii dossier for hbcdd
TRANSCRIPT
Substance Name: Hexabromocyclododecane
EC Number(s): 247-148-4 and 221-695-9
CAS Number(s): 25637-99-4 and 3194-55-6
(the latter numbers are more correct from a chemical point of view as far as the positions of the bro-
mine atoms are specified; the first numbers are also used by industries for commercial use)
Vienna, October 2013
ROHS ANNEX II DOSSIER FOR HBCDD
Restriction proposal for hazardous substance in electrical and
electronic equipment regulated under RoHS
ROHS Annex II Dossier for HBCDD
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CONTENTS
CONTENTS ..............................................................................................3
1 IDENTIFICATION, CLASSIFICATION AND LABELLING, LEGAL STATUS AND USE RESTRICTIONS ...........................................................................5
1.1 Identification .......................................................................................... 5
1.1.1 Name, other identifiers and composition of the substance ..................... 5
1.1.2 Physico-chemical properties ................................................................... 7
1.2 Classification and Labelling Status .................................................... 8
1.3 Legal status and use restrictions ...................................................... 10
2 USE OF THE SUBSTANCE ......................................................12
2.1 Use and function of HBCDD ............................................................... 12
2.2 Use of HBCDD in EEE ......................................................................... 12
2.3 Quantities of HBCDD used in EEE .................................................... 13
3 HUMAN HEALTH ......................................................................15
3.1 Human health hazards ........................................................................ 15
3.2 Endpoints of concern ......................................................................... 15
3.3 Existing guidance values ................................................................... 19
3.4 Preliminary DNEL derivation .............................................................. 19
4 ENVIRONMENT .........................................................................22
4.1 Environmental fate properties ........................................................... 22
4.2 Environmental hazard ......................................................................... 24
4.2.1 Eco-toxicity studies ............................................................................... 24
4.2.2 Potential for secondary poisoning ......................................................... 25
4.3 Existing Guidance values (PNECs) ................................................... 26
5 WASTE MANAGEMENT OF ELECTRICAL AND ELECTRONIC EQUIPMENT ......................................................27
5.1 Description of relevant waste streams ............................................. 27
5.1.1 WEEE categories containing HBCDD ................................................... 27
5.1.2 Relevant waste materials/components containing HBCDD .................. 27
5.2 Waste treatment processes applied to WEEE containing HBCDD ................................................................................................. 28
5.2.1 Treatment processes applied ................................................................ 28
5.2.2 HBCDD flows during treatment of WEEE ............................................. 29
5.2.3 Treatment processes selected for an assessment under RoHS ..................................................................................................... 32
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5.3 Releases of HBCDD from selected WEEE treatment processes ............................................................................................. 33
5.3.1 Shredding .............................................................................................. 33
5.3.2 Recycling ............................................................................................... 36
5.3.3 Summary of releases from WEEE treatment ........................................ 38
6 EXPOSURE ESTIMATION ........................................................ 39
6.1 Human exposure ................................................................................. 39
6.1.1 Exposure estimates of workers of EEE waste processing plants ..................................................................................................... 40
6.1.2 Monitoring of human exposure at EEE waste processing plants ..................................................................................................... 42
6.2 Environmental exposure .................................................................... 43
6.2.1 Exposure estimates for the environment due to WEEE treatment ............................................................................................... 43
6.2.2 Monitoring data: WEEE treatment sites/locations ................................. 47
7 IMPACT ON WASTE MANAGEMENT ...................................... 50
7.1 Impacts on WEEE management as specified by Article 6 (1) a ....................................................................................................... 50
7.2 Estimation of risks for workers and neighbouring residents .............................................................................................. 51
7.3 Risks estimation for the environment ............................................... 51
8 ALTERNATIVES ....................................................................... 53
8.1 Availability of substitutes / alternative technologies ...................... 53
9 SOCIO-ECONOMIC IMPACT ANALYSIS ................................ 55
9.1 Approach and assumptions ............................................................... 55
9.2 Impact on flame retardant and plastics producers .......................... 56
9.3 Impact on EEE producers .................................................................. 57
9.4 Impact on EEE users .......................................................................... 58
9.5 Impact on waste management ........................................................... 58
9.6 Impact on administration ................................................................... 58
9.7 Total socio-economic impact ............................................................. 59
10 RATIONALE FOR INCLUSION OF THE SUBSTANCE IN ANNEX II OF ROHS ............................................................. 62
11 REFERNCES ............................................................................. 68
12 ABBREVIATIONS ..................................................................... 74
13 LIST OF TABLES ...................................................................... 75
14 LIST OF FIGURES .................................................................... 77
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1 IDENTIFICATION, CLASSIFICATION AND LABELLING, LEGAL STATUS AND USE RESTRICTIONS
1.1 Identification
1.1.1 Name, other identifiers and composition of the substance
Table 1: Substance identity and composition (Source: ECHA, 2008)
EC number: 247-148-4a and 221-695-9
b
EC name: Hexabromocyclododecane and 1,2,5,6,9,10-hexabromo-cyclododecane
CAS number (in the EC in-ventory):
25637-99-4a and 3194-55-6
b
CAS number: 25637-99-4a and 3194-55-6
b
CAS name: Hexabromocyclododecane and
1,2,5,6,9,10-hexabromocyclododecane
IUPAC name: Hexabromocyclododecane
Index number in Annex VI of the CLP Regulation
602-109-00-4
Molecular formula: C12H18Br6
Molecular weight range: 641.7
Synonyms: Cyclododecane, hexabromo; HBCD; Bromkal 73-6CD; Nikkafainon CG 1; Pyroguard F 800; Pyroguard SR 103; Pyroguard SR 103A; Pyrovatex 3887;Great Lakes CD-75P™; Great Lakes CD-75; Great Lakes CD75XF; Great Lakes CD75PC (compacted); (Dead Sea Bro-mine Group Ground FR 1206 ILM; Dead Sea Bromine Group Standard FR 1206 I-LM; Dead Sea Bromine
Group Compacted FR 1206 I-CM)c; FR-1206; HBCD ILM; HBCD IHM
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Table 1 (continued)
Structural formulac
Degree of purity The amount of unknown/contaminants constituents var-
ies (0-5 %) and one identified constituent is tetrabromo-
cyclododecane.
Remarks There are three main chiral diasteromers present in
technical HBCDD, which are α-hexabromocyclo-
dodecane (CAS No 134237-50-6),
beta-hexabromo-cyclododecane (CAS No 134237-51-7),
gamma-hexabromocyclododecane (CAS No 134237-52-
8).
Depending on the production method technical HBCDD
consists of approximately 70-95 % γ-HBCDD and 3-30
% of α- and β-HBCDD due to its production method.
Two additional diastereoisomers, δ-HBCDD and
ε–HBCDD have been found in lower concentrations
(0.5 and 0.3, respectively).
The composition of HBCDD diasteromers is likely to dif-
fer between products from the different manufacturers,
but also to differ between different products of a single
manufacturer (e.g., HBCD-ILM (high-melting) and
HBCD-IHM (low-melting) (ECHA, 2008).
a refers to hexabromocylcododecane (withoutspecifiyng the bromine positions) and is used mainly
by industry for commercial use; b refers to 1,2,5,6,9,10-hexabromocyclododecane (bromine
positions are specified) and is therefore more specific in the chemical point of view; c The formula
depicts 1,2,5,6,9,10-hexabromocyclododecane.
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1.1.2 Physico-chemical properties
Table 2: Physico-chemical properties of HBCDD (Source: ECHA, 2008)
Property Value
Physical state at 20°C and 101.3 kPa
White odourless solid
Melting/freezing point Ranges: 172-184 °C to 201- 205°C
α-HBCDD: 179-181 °C
β-HBCDD: 170-172 °C
γ-HBCDD: 207-209 °C
Boiling point Decomposes at >190 °C
Relative Density 2.38g/cm3; 2.24g/cm
3
Vapour pressure 6.3 10-5
Pa (21 °C)
Water solubility Water:
α-HBCDD: 48.8±1.9 µg l-1
β-HBCDD: 14.7±0.5 µg l-1
γ-HBCDD: 2.1±0.2 µg l-1
Sum of above (HBCC tech-nical product): 65.6 µg l-1
Water-salt medium:
α-HBCDD: 34.3 µg l-1
β-HBCDD: 10.2 µg l-1
γ-HBCDD: 1.76 µg l-1
Sum of above (HBCC tech-nical product): 46.3 µg l-1
Water:
γ –HBCDD: 3.4±2.3 µg l-1
Partition coefficient n-octanol/water (log POW)
α-HBCDD: 5.07 ± 0.09
β-HBCDD: 5.12 ± 0.09
γ-HBCDD: 5.47 ± 0.10
Technical product: 5.625
Flash point n.a.
Flammability n.a.
Explosive properties n.a.
Oxidising properties n.a.
Auto flammability Decomposes at >190°C
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1.2 Classification and Labelling Status
The Classification, labelling and packaging (CLP) regulation1
requires compa-
nies to classify, label and package their substances and mixtures before placing
them on the market.
The regulation aims to protect human health and the environment by means of
labelling to indicate possible hazardous effects of a particular substance. It
should therefore ensure a proper handling, including manufacture, use and
transport of hazardous substances.
A proposal for harmonised classification and labelling based on the CLP Regu-
lation (EC) No 1272/2008, Annex VI, Part 2 has been submitted by the Swedish
Chemicals Agency in 2009. Since 10 July 2012 HBCDD is listed in Annex VI of
the Regulation (EC) No. 1272/2008 as Repro 2, Lact (for details see Table 3).
Additionally to the harmonised classification HBCDD is classified as Aquatic
Acute 1 and Aquatic Chronic 1 (Hazard class H400 and H410) by numerous
manufactures and/or importers as indicated in the C&L inventory provided by
ECHA2.
In accordance with Directive 67/548/EEC HBCDD is classified as Repr. Cat 3;
R63 (possible risk of harm to the unborn child) R64 (may cause harm to breast-
fed babies) and labelled with Xn; R 63 - 64; S36/37-53.
1 Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006
2 for details see: http://echa.europa.eu/web/guest/information-on-chemicals/cl-inventory-database
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Table 3: Harmonized classification of HBCDD1
Index No
International Chemical Identificati-on
EC No CAS No Classification Labelling Spec. Conc. Limits, M-factors
Notes
Hazard Class and Category Code(s)
Hazard statement code(s)
Pictogram, Signal Word Code(s)
Hazard state-ment code(s)
Suppl. Hazard statement code(s)
602-109-00-4
Hexabromocyclododecane [1]
1,2,5,6,9,10- hexabromocyclododecane [2]
247-148-4 [1]
221-695-9[2]
25637-99-4[1]
3194-55-6[2]
Repr. 2
Lact.
H361 H362 GHS08 Wng H361 H362
-- -- --
1 Classification according to part 3 of Annex VI, Table 3.1 (list of harmonized classification and labelling of hazardous substances) of the CLP Regulation Regulation (EC) No 1272/2008 of the
European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures.
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1.3 Legal status and use restrictions
REACH regulation3
HBCDD has been identified as a Substance of Very High Concern (SVHC),
meeting the criteria of a PBT (persistent, bio-accumulative and toxic) pursuant
to Article 57(d) in the REACH regulation. On February 17, 2011 the European
Commission decided to include HBCDD in Annex XIV to REACH regulation.
Specific authorisation for HBCDD will be required for a manufacturer, importer
or downstream user to place the substance on the market, use it in preparations
or for the production of articles.
Stockholm Convention
In 2008 the Government of Norway, as a Party to the Stockholm Convention,
submitted a proposal to list HBCDD in Annex A to the Stockholm Convention.
The Persistent Organic Pollutants Review Committee (POPRC) of the Stock-
holm Convention concludes that HBCDD meet the characteristics defined in
Annex D. On May, 2013 the conference of parties (COP) has decided within the
sixth meeting of to the Stockholm Convention4 to amend part I of Annex A to list
HBCDD with specific exemptions for production and use in EPS and XPS in
buildings.
Interference REACH and Stockholm Convention
The European Commission has taken the decision of opting-out on a temporary
basis from the listing of HBCDD under the Stockholm Convention as the sub-
stance is covered by Union legislation (REACH).Therefore, in line with Article
25 (2) of the Convention and the Declaration of Competence submitted by the
EU, it is for the Commission to communicate to the Secretariat on behalf of the
EU the intention to temporarily opt-out from the Decision on HBCDD. The opt-
out is done with binding effect for the Union and all its Member States (EC,
2013). Finally, the EU must opt-in again to the Decision as soon as it is possible
once the legal conflict with the EU acquits has seized to exist, which presently is
expected to be possible in August 2015 subject to the proceedings of the au-
thorisation process.
WEEE Directive5
Most relevant in the context of HBCDD is the provision of the EU´s WEEE Di-
rective to remove plastics containing brominated flame retardants from any
separately collected electrical and electronic equipment. Furthermore, the re-
moval of printed circuit boards of mobile phones generally, and of other devices
if the surface is > 10 cm2 and of external electrical cables, which may also con-
tain HBCDD to a minor extent, is requested.
3 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH).
4 28
th April – 10
th May, 2013
5 Directive 2012/19/EU of the European Parliament and of the Council on waste electrical and elec-tronic equipment (WEEE) (recast)
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Occupational exposure limits
No occupational exposure values for HBCDD have been established in Europe
so far. There are no entries regarding occupational exposure limits of HBCDD in
the EU SCOEL (Scientific Committee on Occupational Exposure Limits) docu-
ment database.
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2 USE OF THE SUBSTANCE
2.1 Use and function of HBCDD
HBCDD is solely used as an additive flame retardant, with the intent of delaying
ignition and slowing subsequent fire growth (IOM, 2009). It can be used on its
own or in combination with other flame retardants.
In general HBCDD is mainly used in four different applications:
Expandable Polystyrene (EPS);
Extruded Polystyrene (XPS);
High Impact Polystyrene (HIPS) relevant for EEE
Polymer dispersion for textiles.
According to SWEREA (2010) some other uses of HBCDD have been reported.
For example, the use of HBCDD in polypropylene (PP), adhesives, latex bind-
ers and unsaturated polyester has been reported in the USA. A minor use of
HBCDD in PP was reported by industry. HBCDD can be used in adhesives and
coatings and in SAN resins (styrene-acrylonitrile copolymer). It may also be
used in polyvinylchloride (PVC) products, such as wires, cables and textile coat-
ings.
2.2 Use of HBCDD in EEE
HBCDD is used in EEE in plastic parts made of HIPS. The main applications of
flame retarded HIPS are in housings of appliances such as television sets, au-
dio-videos and personal computers but it has also been mentioned to be used
for electrical boxes and wiring fittings, electrical appliance parts, business ma-
chines, and interior parts of refrigerators DEPA (2010).
According to DEPA (2010) indication is given that on the European market en-
closures of computer monitors seem generally not to be made of HIPS, but of
acrylonitrile butadiene styrene (ABS) or co-polymer of polycarbonate (PC)/ABS
due to their higher impacts strength and resistance to cracking. It is also stated
that major European manufacturers of TV sets seemed to be using copolymers
like PC/ABS, PS/PPE or PPE/HIPS6 either without flame retardants, or with
non-halogenated flame retardants.
According to GENERAL ELECTRIC (2006) 14% of the global plastic consumption
for flat panel TV sets is HIPS with flame retardants7.
6 Such copolymers have a higher inherent resistance to burning and spreading a fire, because they form an insulating char foam surface when heated. Further they have higher impact strength.
7 The remainder are 33% HIPS without flame retardants, 42% PC/ABS, 10% modified PPE and 1% other (General Electic, 2006)
Main uses of
HBCDD
Minor uses of
HBCDD
Main uses of
HBCDD in EEE
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Recent analyses of waste flat panel screens described by SALHOFER ET AL.
(2012) showed that in PC monitors 1.7% of all polymers contained brominated
flame retardants8. In TV screens 8.6% of all polymers contained brominated
flame retardants9.
HBCDD is also used as a flame retardant in printed circuit boards (MORF et al.,
2005). Analysed samples from the Swiss market contained approximately
10mg/kg HBCDD in circuit boards, 10 mg/kg HBCDD in TV housings (wood),
50mg/kg HBCDD in TV/PC housings (plastic) and 1400 mg/kg HBCDD in TV
rear covers. The most abundant detected flame retardants, however, in the ana-
lysed samples have been Decabrominated diphenylether (DecaBDE) and
tetrabromobisphenol A (TBBPA).
2.3 Quantities of HBCDD used in EEE
Information on the overall consumption and production of HBCDD in the EU is
available from several pieces of work conducted in the context of the application
of the REACH Regulation.
According to IOM (2009) the annual consumption in the EU in 2007 was esti-
mated to be 11,000 tonnes, of which the bigger part (70-90%) is applied in EPS
and XPS polymers for building insulation materials. Less than 10% (1,100 t/y) is
used in HIPS and an estimated 2% (220 t/y) is used for back coating of flame
retarded textiles.
It has been estimated by Öko-Institut (2008) that approximately 210 t of HBCDD
are used annually in EEE products in the EU.
Information on imports and exports of HBCDD in formulations and articles,
however, is available only fragmentarily. In particular EEE imports from third
countries will have a significant impact on the quantities of HBCDD in the EU.
According to DEPA (2010) this is notably the case for small household appli-
ances, consumer electronics, IT equipment, and toys etc., but also for other
EEE groups.
For estimating the quantity of HBCDD entering the European market via EEE to
be used for this assessment the following assumptions were made.
Only HBCDD in HIPS was considered10
.
Different sources report a HBCDD-content in HIPS between 1 - 7 % (w/w) (IOM,
2009). As a worst case scenario a content of 7% was assumed – like in the Risk
Assessment Report for HBCDD (EC, 2008).
SWEREA (2010) expect that around 10% of the total polystyrene market applies
HBCDD in their end products. According the European Brominated Flame Re-
tardants Industry panel11
5 percent of all HIPS in the EU is flame retarded with
8 another 1.7% of the polymers were none flame retarded PS
9 another 14.3% of the polymers were non flame retarded PS
10 Minor uses of HBCDD in PP, PVC etc. were not considered.
11 Cited in KemI (2006) cited in DEPA (2010)
HBCDD quantity in
European EEE
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HBCDD. For the present assessment it is assumed that 5% of HIPS in EEE
contain HBCDD.
According to VKE (2003) 14% of all plastics in EEE are HIPS.
According to a literature review conducted by EMPA (2010) HIPS is used in
EEE as follows. cooling and freezing appliances (95,000 t/a), in small electronic
appliances (111,000 t/a), in consumer equipment without screens (CRT moni-
tors or flat screens) (100,000 t/a), in CRT monitors (39,000 t/a) and TV sets
(120’000 t/a). Relevant amounts are furthermore used in other large household
appliances than cooling and freezing appliances and in IT equipment other than
screens. According to the authors these figures are characterized by significant
uncertainties.
Thus for the purpose of the present assessment the HBCDD quantity entering
the European market via EEE was estimated as follows:
In 2010 9.4 Mio tonnes of EEE were placed on the market in the EU
stat12
). Assuming a plastic content in EEE of 30% of the appliance´s weight13
an
overall amount of 1,400 tonnes of HBCDD entering the European market via
flame retarded plastic parts in EEE is assumed for the present assessment.
12
http://www.eea.europa.eu/data-and-maps/indicators/waste-electrical-and-electronic-equipment/assessment-1
13
See e.g. Schlummer et al (2007)
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3 HUMAN HEALTH
3.1 Human health hazards
Different official bodies have assessed the toxicity and human health risk re-
lated to HBCDD exposure (e.g., EC, 2008; ECHA, 2010b, EFSA, 2011). The
main outcome of these assessments is summarized below, whereas the end-
points of concern are in more detail depicted in chapter 3.2. For more back-
ground information and further reading, the reader is referred to the original
documents.
The acute toxicity of HBCDD is low. The oral lethal dose is >20g/kg bw in rats
and >10g/kg bw in mice. Furthermore, the outcome of toxicological studies re-
vealed that the compound is not corrosive, irritating or sensitizing to the skin.
HBCDD lacks genotoxic potential in vitro and in vivo. Based on reported data
and the absence of mutagenicity it is concluded in the EU risk assessment re-
port (RAR) that there are no indications to study the carcinogenic effect of
HBCDD further (EC, 2008).
Sub-chronic and chronic toxicity studies identified liver, thyroid, prostate, repro-
ductive, nervous and immune system as the main targets of HBCDDs toxicity
(ECHA, 2008; EFSA, 2011). From the repeated dose toxicity studies a
NOAEL/BMD-L of 22 mg/kg/day was deduced based on changes of the liver
weight (ECHA, 2008).
Since adverse outcomes on the reproductive system have to be harmonised
classified according to the CLP regulation, a proposal for harmonised classifica-
tion and labelling has been submitted by Sweden in 2009, the risk assessment
committee (RAC) has adopted the opinion for a harmonised classification in
2010 (ECHA, 2010b). HBCDD is listed in Annex VI of the CLP regulation as
Repr. 2 (H361) and Lact. (H361).
3.2 Endpoints of concern
HBCDD exposure has an impact on the reproductive system and developmen-
tal system. Furthermore, liver, thyroid, prostate and immune and nervous sys-
tem has been identified as target organs of HBCDD toxicity.
Main findings of studies carried out to investigate toxicity effects of HBCDD on
the developmental and reproductive system, include a two-generation study
(Ema et al., 2008), a one-generation study (van der Ven et al., 2009), a one-
generation developmental study (Saegusa et al., 2009), as well as neurodevel-
opmental studies (Lilienthal et al., 2007, Eriksson et al., 2006). Study outcomes
and deduced toxicological values (such as no observed adverse effect levels –
NOAELs, lowest observed adverse effect levels - LOAELs, bench mark dose -
BMD) are summarised in Table 4.
There are observations of increased postnatal mortality, delayed physical de-
velopment, and alterations in the weight of internal organs in offspring in the
one and two-generation studies (Ema et al., 2008, van der Ven et al., 2009,
Outcome of hazard
assessment(s) in
brief
Acute toxicity
Carcinogenicity
Repeated dose
toxicity studies
Reproductive and
developmental
system
Adverse effects on
development and
fertility
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Saegusa et al. 2009) at dose levels inducing mild maternal toxicity. Based on
the available data the contribution of prenatal developmental alterations to
these postnatal manifested effects cannot be excluded (ECHA, 2010a).
The outcome of the study of Ema et al. (2008) indicates potential effects of
HBCDD on fertility - such as reduction of primordial follicles in ovaries of F1
generation females in the medium and high dose exposure levels.
Studies in rodents indicate that HBCDD exposure during development affects
the nervous system with subsequent behavioural changes. The results of the
study of Eriksson et al. (2006) provide the lowest observed doses at which an
adverse effect has been observed. Male NMRI mice were exposed to a dose of
0.9 or 13.5 mg/kg b.w. of technical HBCDD on PND10. Behavioural effects such
as changes in rearing, locomotion and habituation, in response to a novel envi-
ronment were already observed at a dose level of 0.9 mg/kg b.w. Neurodevel-
opmental effects have been also observed in F1 and F2 offsping at the highest
dose level of approximatly 1000 mg/kg bw in a two generation study carried out
by Ema et al. (Ema et al., 2008). In an one generation study with Wistar rats re-
duced latencies to movement at exposure levels of 0.6-4.4 mg/kg b.w. and for
increased thresholds in the brainstem auditory evoked potential (BAEP) were
observed at 0.2-0.9 mg/kg b.w. per day. In rat offspring from dams that were
exposed from GD10 until PND10 effects on oligodendroglial development were
observed at the highest dose levels of 10.000 mg/kg feed (Saegusa et al.,
2009).
Effects of repeated dose toxicity studies indicate effects of HBCDD on the thy-
roid and the liver, as well as effects on the prostate.
A NOAEL of 22 mg/kg bw based on the increased liver weight has been de-
duced (ECHA, 2011).
The increased liver weight is assumed to be related to an induction of liver en-
zymes. The effects of HBCDD on the thyroid system are thoroughly discussed
in the EU RAR (EC, 2008). It is supposed that also the effects on the thyroid
system is related to liver enzyme induction, however, there is still some un-
certainty regarding the mode of action.
Evidence that orally administered HBCDD has an impact on the immune system
comes from a 28-day repeated dose toxicity study carried out by van der Ven
(van der Ven et al., 2006) and from a one-generation reproductive study (van
der Ven et al., 2009) (for details see EFSA, 2011). Decreased splenocytes
counts were observed in the 28-day repeated dose study and the whole white
blood fraction, as well as the lymphocyte counts were decreased in the one
generation study. Furthermore, a decreased thymus and popliteal lymph node
weight, an enlarged spleen zone was observed in the one-generation study with
rats.
Table 4 summarises the toxicity values as well as the major outcome of animal
studies conducted in order to investigate the effect of HBCDD on the develop-
ment, fertility and also on the endocrine system (e.g., thyroid hormones). The
respective studies have been thoroughly assessed and are described in the EU
risk assessment report.
Neurodevelopmental
effects
Outcome of
repeated dose
toxicity studies
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Table 4: Main findings of developmental and repeated-dose toxicity studies (Source: EFSA, 2011)
Study type Species Application and exposure levels
Outcome LOEL(*) NOEL(*) BMDL* Reference
Developmental Toxicity Studies
Two-generation study (according to OECD guideline 416
and GLP)
Crl:CD(SD) rats Orally; in the diet.
0, 150, 1500 or 15000 mg/kg diet
10-14, 101-141, or 1008-1363 mg/kg b.w. day
Decrease in fertility index in F0 and F1 animals
Decrease in ovary primordial follicles in F1 females
Decreased thyroid follicle size
Increase of thyroid weight in F0 and F1 animals
Decrease in serum T4 in all animals
Increase in serum TSH in F0 and F1 females
1,500 mg/kg
diet (100 mg/kg b.w.)
150 mg/kg diet (10 mg/kg b.w.)
-- Ema et al., 2008
One-generation study (according to OECD 415)
Wistar
rats
Orally; in the diet.
0,1; 0,3; 1; 3; 10; 30 and 100 mg/kg b.w. per day in the feed.
Exposure before mating till 11 weeks of age of F1.
Decrease in testes weight
Increased anogenital distance (PND4)
Delayed vaginal opening
Increased IgG response
Decreased trabecular bone mineral density (females)
Decreased in apolar retinoids
-- -- Testes: BMDL5 11.5 mg/kg b.w. per day
IgG response:
BMDL20: 0.46 mg/kg b.w. per day
Bone mineral density:
BMDL10 0.056 mg/kg b.w. per day
Retinoids:
BMDL10 1.3 mg/kg b.w. per day
van der Ven et al., 2009
1-generation devel-opmental toxicity study (no guideline study)
Pregnant Spra-gue-Dawley rats
Orally; in the diet.
100, 1,000 and 10,000 mg/kg diet
8-21, 81-213, or 803-2231 mg/kg b.w./day
From mid-gestation through lactation
Reduced number of CNPase-positive oligodendroglia in the cortex
Increased relative thyroid weight in male
Thyroid follicular cell hyper-trophy
Decreased serum T3
1.000 mg/kg diet (81-213 mg/kg b.w./day)
100 mg/kg diet (8-21 mg/kg b.w./day)
-- Saegusa et al., 2009
One-generation re-productive study (ac-cording to OECD 415)
Wistar
WU
(CBP) rats
Orally; in the diet.
1.43, 4.29, 14.3, 42.9, 143, 429, 1,430 mg/kg in diet
0.1, 0.3, 1, 3, 10, 30, 100 mg/kg b.w.
Before mating to 11 weeks
Brainstem auditory evoked potential alterations sugges-tive for cochlear defect
Reduced latency to move af-ter haloperidol
-- -- Brainstem auditory evoked po-tential: 1-6.3 mg/kg b.w. per day
Catalepsy: 0.6-4.4 mg/kg b.w. per day
Lilienthal et al., 2009
(in addition to main publication von van der Ven et al., 2009)
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Study type Species Application and exposure levels
Outcome LOEL(*) NOEL(*) BMDL* Reference
Developmental Neu-rotoxicity study
NMRI mice Orally, via gavage, single dose.
0.9 or 13.5 mg/kg b.w./ day
PND10
Behavioural disturbances 0.9 mg/kg b.w.
-- -- Eriksson et al., 2006
Repeated dose toxicity studies
90-day oral toxicity study
Sprague Dawley rats
Orally; via gavage;
100, 300 or 1,000 mg/kg b.w. per day
Thyroid effects: Decrease in serum T4 Increase in TSH Thyroid follicular cell hyper-trophy
Increased thyroid weight (fe-males)
Increase in relative prostate weight
Liver effects: Liver weight increase in both sexes
300 mg/kg b.w. per day
100 mg/kg b.w. per day
Chengelis et al, 2001
28-day study Wistar rats Orally; via gavage;
0.3, 1, 3, 10, 30, 100 and 200 mg/kg b.w. per day by gavage
Thyroid effects:
Increased thyroid weight (fe-males)
Decreased total T4
Increased TSH immunostain-ing and weight pituitary
Liver effects:
Increased hepatic capacity of T4 UGT (f)
Increased liver weight (fmales)
--- NOAEL/BMD-L 22.9 mg/kg bw (**) – liver weight in-crease (hepati-tis enzyme in-duction)
Increased thyroid weight: BMDL10: 1.6 mg/kg b.w. per day
T4 decrease: BMDL10: 55.5
mg/kg b.w. per day
Pituitary weight: BMDL10 29 mg/kg b.w. per day
Splenocyte count: BMDL20 104 mg/kg b.w. per day
T4 UGT: BMDL10: 4.1 mg/kg b.w. per day
Liver weight: BMDL20: 23 mg/kg b.w. per day
Van der Ven et al., 2006
LOEL: lowest-observed-effect level; NOEL; no-observed-effect level; BMD(L): benchmark dose (limit); TSH: thyroid-stimulating hormone; T4: thyroxine; T3: triiodothyronine UGT: UDP;
glucuronosyltransferase; RSV: respiratory syncytial virus; GD: gestational day; PND: postnatal day; * deduced by EFSA, 2011;
** deduced by EC, 2008
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 19
3.3 Existing guidance values
An overview on derivation of International occupational exposure limits (OELs)
is provided by the European Agency for Health and Safety at work (EU-OSHA
website14
). No international limit values are published on the database of haz-
ardous substances provided by the Institute for Occupational Safety and Health
of the German Social Accident Insurance (GESTIS15
). No OEL has been de-
rived by the European Scientific Committee on Occupational Exposure Limits
(SCOEL)16
. No OELs and threshold limit values (TLVs) of HBCDD are given at
the International Chemical Safety Card -ICSC database, which was prepared in
the context of cooperation between the International Programme on Chemical
Safety and the European Commission17
.
3.4 Preliminary DNEL derivation
So far, no derived no effect levels (DNELs) have been deduced for HBCDD by
official bodies. Therefore, within the present assessment preliminary DNELs are
going to be estimated based on the REACH guidance18
.
Within the REACH regulation the DNEL (derived no effect level) approach has
become an important method to further characterise a possible risk. The DNEL
is in most cases due to absence of relevant human studies deduced from ani-
mal data.
Within the present assessment the point of departure to calculate the prelimi-
nary DNELs is deduced form the study of Eriksson et al. (2006) based on the
negative impact of HBCDD administered to mice at PN10 on the neurodevel-
opmental behaviour of off-springs at a dose level of 0.9 mg/kg bw.
The recent assessment from EFSA has selected the study of Eriksson et al.
(Eriksson et al., 2006) as basis for human risk characterisation (EFSA, 2011).
Although there are several drawbacks and uncertainties within the use of the
single-dose administration study, the CONTAM Panel stated that there are ar-
guments for the use of the study including that the results provide the lowest
doses leading to effects and that a relevant neurodevelopmental period is cov-
ered by the study, which needs particular consideration. The CONTAM Panel
concluded that based on the uncertainties in the database an application of the
margin of exposure approach is more appropriate than the deduction of a TDI.
Besides the application of an assessment factor for inter and intraspecies dif-
ferences, for which default values given in the REACH guidance have been
used, an assessment factor of 3 for taking into LOAEL to NOAEL extrapolation
14
EU-OSHA: https://osha.europa.eu/en/topics/ds/oel/nomembers.stm 15
GESTIS-GefahrenSToffInformationsSystem – database of hazardous substances provided by In-stitute for Occupational Safety and Health of the German Social Accident Insurance (IFA); http://limitvalue.ifa.dguv.de/Webform_gw.aspx
16 SCOEL: http://ec.europa.eu/social/main.jsp?catId=148&langId=en&intPageId=684 http://www.ilo.org/dyn/icsc/showcard.listCards2
17 http://www.cdc.gov/niosh/ipcsneng/neng1413.html
18 ECHA Guidance on information requirements and chemical safety assessment; Chapter R.8: Characterisation of dose[concentration]-response for human health (available at: http://echa.europa.eu/documents/10162/13632/information_requirements_r8_en.pdf)
International limit
values
Point of departure
Assessment factors
ROHS Annex II Dossier for HBCDD
20 Vienna, October 2013
has been applied. Thus, the applied factor for workers is 150 and for the gen-
eral population 300.
Furthermore a difference in the absorption between rats (85%) and humans
(100%) humans has been considered for the deduction of the oral LOAEL. This
assumption has also been considered by EFSA (EFSA, 2011). Therefore the
corrected oral LOAEL is 0.79 mg/kg bw/day. The calculated DNEL (long-term)
for the general population is estimated to be 0.0026 mg/kg bw/day.
The oral LOAEL rat was converted into a dermal corrected LOAEL by correcting
for differences in absorption between routes (5% absorption is considered for
the dermal route). Further correction for exposure during 5 days a week instead
of 7 days a week has been applied to derive a dermal DNEL for workers.
The oral LOAEL in rat was converted into an inhalation corrected LOAEC (in
mg/m3) by using a default for respiratory volume for the rat corresponding to the
daily duration of human exposure (general population: 0.79 mg/kg bw/day / 1.15
m3/kg bw, workers: 0.79 mg/kg bw/day / 0.38 m3/kg bw x 6.7 m3/10 m
3).
Preliminary derived no effect levels (DNELs) for worker and general population
for the oral, dermal and inhalation route are presented in Table 5.
Preliminary DNEL
oral
Preliminary DNEL
dermal
Preliminary DNEL
inhalation
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 21
Table 5: Preliminary derived no effect levels (DNELs) deduced for the present
assessment
Assessment Factors
Workers General population
(Adults& Children)
Interspecies, AS* 4 4
Interspecies, remaining differences 2,5 2,5
Intraspecies 5 10
Dose response (LOEAL to NOAEL ex-trapolation)
3 3
Quality of database 1 1
Applied Factor* 150 300
ORAL
Absorption (%) 100% 100%
LOAEL (corrected) (not relevant) 0.79
DNELs ORAL in mg/kg/d (not relevant) 0.0026
DERMAL
Absorption (%) 5% 5%
LOAEL (corrected) 11.3 15.8
DNELs DERMAL in mg/kg/d 0.075 0.052
INHALATION
Absorption (%) 100% 100%
Standard respiratory volume in m3/kg
bw per day 0.38 1.15
LOAEL (corrected) 1.39 0.69
DNECs INHALATION in mg/m3 0.009 0.002
ROHS Annex II Dossier for HBCDD
22 Vienna, October 2013
4 ENVIRONMENT
An in-depth evaluation of the environmental fate properties and adverse effects
on the ecological system of HBCDD has been published in the frame of the
European risk assessment reports in 2008 (EC, 2008).
In the following section the environmental fate properties are described and
compared with the Persistence and Bio accumulative criteria (PBT criteria) set-
tled down in Annex XIII of the REACH regulation, as well as with the criteria in-
dicated in Annex D of the Stockholm Convention (POPs criteria) (Table 7).
The predicted no effect levels (PNEC) depicted in chapter 4.3 have been previ-
ously deduced within the EU RAR (EC, 2008).
4.1 Environmental fate properties
HBCDD has a very high bio-accumulative potential and data have proven that
HBCDD is persistent in the environment. There is a large set of measured data
indicating that HBCDD is biomagnified in the environment.
HBCDD meets the characteristics as global persistent organic pollutant (POP)
according to the Stockholm Conventions criteria defined in Annex D and the cri-
teria as persistent, bioaccumulative and toxic (PBT) substance defined in the
REACH regulation (Annex XIII). A brief summary of these evaluations is given
below.
On 18th June 2008 a proposal to amend HBCDD to Annex A to the Stockholm
Convention has been submitted by the Government of Norway. After various
foreseen evaluation steps, the conference of parties (COP) within its sixth meet-
ing (May 2013) has decided to include HBCDD to Annex A to the Stockholm
Convention (UNEP, 2013).
HBCDD meets the criteria defined within the Stockholm Convention to be per-
sistent and bio-accumulative. Furthermore, HBCDD fulfils the characteristics to
have a potential for long-range environmental transport and it possess adverse
effects to organisms.
A brief summary of the evaluation is given in Table 6. Documents for further
readings are provided on the website of the Stockholm Convention19
, at which
the reviewing process of HBCDD is transparent documented.
19
Substances, which have been reviewed within the Stockholm Convention http://chm.pops.int/Convention/POPsReviewCommittee/Chemicals/tabid/243/Default.aspx
HBCDD a global
POP
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 23
Table 6: Persistent organic pollutant (POP) characteristics of HBCDD
Criterion Outcome
Persistence Half-life of HBCDD in water exceeds 60 days. Data sediment cores indicate slow degradation
HBCDD is found to be widespread in the global environ-ment. High levels of HBCDD are found in Artic top preda-tors.
Data indicate that HBCDD levels increase temporally in biota.
Bioaccumulation Log Kow is more than 5 (estimated to be 5.62).
BCF of 18,100 (fish studies).
BMF higher than 1 (aquatic ecosystems).
Higher HBCDD levels in top predators
Potential for long-range environmental transport
Estimated atmospheric half-life of HBCDD is two to three days.
HBCDD is found widespread in Artic environment and has been detected in Artic air.
Adverse effects HBCDD is highly toxic to aquatic species (72h EC50 of 52 µg/L for Skeletonema costatum, NOEC of 3.1 µg/l for Daphnia magna).
HBCDD exerts reproductive, developmental and neuro-toxic effects in mammals and birds (NOEC, NOAEL in the order of 1 mg/kg/day).
HBCDD is a substance of very high concern (SVHC) meeting the PBT criterion
defined under the REACH regulation (Annex XIII). An assessment if these crite-
ria are met has been carried out in the year 2008.
The following table summarises the parameters characterising the environ-
mental fate properties of HBCDD.
Table 7: Environmental parameters in comparison with PBT1 and POPs
2 criteria
Parameter Outcome PBT criteria (ac-cording REACH, Annex XIII)
POPs criteria (Stockholm Convention)
Half life
air soil
> 2 ds 210 ds
> 2 ds > 120 ds
- >180 ds
Log Kow 5.62 -- >5
Bio-concentration factor 18 100 (fish) >2000 l/kg >5000 l/kg
T criterion A 21d-NOEC of 3.1 μg/l has been derived for Daphnia magna
The long-term no-observed effect con-centration (NOEC) for marine or fresh-water organisms is less than 0,01 mg/l
Toxicity or ecotoxicity data that indicate the potential for damage to
human health or to the environ-ment
1 defined in Annex XIII of the REACH-regulation;
2defined in Annex D of Stockholm Convention
PBT Substance
ROHS Annex II Dossier for HBCDD
24 Vienna, October 2013
4.2 Environmental hazard
4.2.1 Eco-toxicity studies
HBCDD studies with aquatic species indicate high toxicity (72h EC50 of 52 µg/L
for Skeletonema costatum, NOEC of 3.1 µg/l For Daphnia magna).
Based on these outcomes and also on evidences from mammalian studies, the
T criterion (REACH) is met and also the defined criteria set out in Annex D of
the Stockholm convention to possess adverse effects on environmental organ-
ism.
Results of the eco-toxicity testing described in the EU RAR are depicted in Ta-
ble 8 below (EC, 2008).
Table 8: Outcome of eco-toxicity studies (Source: EC, 2008)
Species Method Results
Aquatic compartment: Fish
Onchorhyncus mykiss (Rainbow trout)
OECD 203 and TSCA 40/797/1400, and ASTM Stan-dard E729-88a
No mortalities or other effects around 2.5 μg/l.
Oncorhynchus mykiss (Rain-bow trout)
Flow-through OECD 210 and OPPTS 850.1400
NOEC : Hatching success ≥3.7 μg/l; Swim-up ≥3.7; Larvae and fry survival ≥3.7; Growth ≥3.7
Aquatic compartment: Invertebrates
Daphnia magna (Water flea)
OECD 202. Static
immobilisation test, and
TSCA 40/797/1300, and
ASTM Standard E729-88a
48 h EC50 >3.2 μg/l
Daphnia magna (Water flea)
TSCA , OECD
Flow through 21 day test.
NOEC 3.1 μg/l
LOEC length 5.6 μg/l
Aquatic compartment: algae
Selenastrum capricornutum OECD 201 and
TSCA40/797/1050
96 h EC50 >2.5 mg/l
Skeletonema costatum
Thallassiosira pseudonana
Chlorella sp.
Marine algal bioassay
method, different marine
growth media
72 h EC50 =
9 μg/l (lowest value)
72 h EC50 =
40 μg/l (lowest value)
96h EC50 >water solubility
Skeletonema costatum OECD 201, ISO
10253:1995 and EU
Directive 92/69/EEC
Method C.3
NOEC <40.6 μg/l
EC50 >40.6
Skeletonema costatum OECD 201 NOEC >10 μg/l
EC50 52 μg/l
Sewage treatment plant: microorganisms
Microorganism; activated sludge
Respiration inhibition; OECD 209
EC50 15 mg/l; Limit test with one test concentra-tion, EC50 is estimated.
Main conclusion on
eco-toxicity studies
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 25
Species Method Results
Sediment compartment: Invertebrates
Hyalella Azteca (Amphipod) Sediment toxicity test 28-day ex-posure period under flow-through conditions.
LOEC >1000 mg/kg dwt of sediment
NOEC 1000 mg/kg dwt of
sediment.
Lumbriculus variegatus (Worm)
28d- sediment bioassay LOEC = 28.7 mg/kg dwt
NOEC = 3.1 mg/kg dwt
Normalized:
NOEC = 8.61 mg/kg dwt
Chironomus riparius (Mos-quito)
28d- sediment bioassay
Egg production of F
generation
LOEC = 159 mg/kg dwt
NOEC = 13.6 mg/kg dwt
Normalized:
NOEC = 37.8 mg/kg dwt
Terrestrial compartment: Soil microorganisms
Soil microorganisms Nitrogen transformation
test
OECD 216
NOEC > 750 mg/kg dry
soil
Terrestrial compartment: Plants
Zea mays (corn), Cucumis sativa (cucumber), Allium cepa (onion), Lolium perenne (ryegrass), Glycine max (soybean), and Lycopersicon esculentum (tomato)
Seedling emergence, survival, height
21 days
OECD 308 (proposal for revi-sion), 850.4100 and 850.4225 (public drafts)
NOEC >5000 mg/kg dry
soil
Terrestrial compartment: Invertebrates
Eisenia fetida (Earthworm) Survival and reproduction,
56 days
OECD prosal and 207 and
OPPTS 850.6200
NOEC 128 mg/kg dry soil
Normalized:
NOEC 59 mg/kg dry soil
(EC50 771 mg/kg dry soil)
1 bold tvalues have been used within the RAR to deduce PNEC values.
4.2.2 Potential for secondary poisoning
Secondary poisoning is a phenomenon related to toxic effects which might oc-
cur in higher members of the food chain resulting from ingestion of organisms
from lower trophic levels that contain accumulated substances. Thus, chemicals
which have bioaccumulation and biomagnification properties within the food
chain possess an additional threat.
HBCDD accumulates in organisms such as fish. Therefore, fish feeding mam-
mals and birds are exposed to HBCDD. In addition, predators feeding marine
mammals and birds are highly exposed to HBCDD.
Based on the data assessed within the EU RAR the PNEC for secondary poi-
soning is 5 mg HBCDD/kg wt food (EC, 2008).
A comparison of measured levels in fish and marine mammals indicate that they
are mostly below the estimated PNEC.
Secondary
poisoning
ROHS Annex II Dossier for HBCDD
26 Vienna, October 2013
However the PNEC value is uncertain and there are numerous studies indicat-
ing higher HBCDD concentrations (e.g., in marine mammals, eel and brown
trout) than the estimated PEC.
It is concluded, that even though the PNEC for secondary poisoning is uncertain
there is a potential for secondary poisoning of e.g., predatory mammals and
birds as indicated by measured concentrations (EC; 2008, ECHA; 2008).
4.3 Existing Guidance values (PNECs)
The predicted no effect concentration (PNEC) is the concentration below which
exposure to a substance is not expected to cause adverse effects to species in
the environment. Therefore the determination of these values is important for
further risk evaluation.
Based on the eco-toxicity studies described in Table 8 following PNECs have
been estimated (EC, 2008), which are used in the present evaluation for further
risk characterisation (details see chapter 7.3).
Table 9: Deduced predicted no effect concentrations (PNECs) for different
compartments (Source: EC, 2008)
Compartment NOEC Safety factor PNEC
Aquatic compartment
Aquatic Compartment 3.1 µg/l 10 0.31 µg/l
Intermittent release; aquatic Compartment
50 µg/l 100 0.5 µg/l
Marine Environment 30 µg/l 100 0.03 µg/l
Intermittent release, marine environment
50 µg/l 1000 0.05 µg/l
Sediment 8.6 µg/l 10 0.86 mg/kg dwt
Sediment, marine environ-ment
8.6 µg/l 50 0.17 mg/kg dwt
Micro-organisms in sewage treatment plants
15 mg/l 100 0.15 mg/l
Terrestrial compartment
Terrestrial Compartment 59 mg/kg dwt 10 5.9 mg/kg dwt
Atmospheric compartment
Atmosphere -- -- No PNEC derivation
Secondary poisoning
Secondary poisoning 150 ppm 30 5.0 mg/kg food
PNECs for different
compartments
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 27
5 WASTE MANAGEMENT OF ELECTRICAL AND ELECTRONIC EQUIPMENT
5.1 Description of relevant waste streams
5.1.1 WEEE categories containing HBCDD
DEPA (2010) compiled an overview on the presence of HBCDD flame retarded
parts in the 10 WEEE categories specified in Annex I to the WEEE Directive.
Taking into account additional information on HBCDD applications in EEE (see
Chapter 12) and data on HBCDD contents analysed in WEEE (see Chapter
5.1.2 below) the following can be concluded regarding the presence of HBCDD
in WEEE (12).
Table 10: Presence of HBCDD in the 10 WEEE categories as specified by Annex I to the WEEE Directive (Source:
DEPA, 2010, adapted by Umweltbundesamt)
WEEE Category Insulation board of EPS or XPS
HIPS cabinets/ enclosures
HIPS wiring fittings
Brominated epoxy / PCBs
PVC / cables
1. Large household appliances possible x possible x (minor)
2. Small household appliances x possible x (minor) x (minor)
3. IT and telecommunications equipment
x (main) possible x (minor) x (minor)
4. Consumer electronics x (main) possible x (minor) x (minor)
5. Lighting equipment possible possible x (minor) x (minor)
6. Electrical and electronic tools (ex-cept large-scale stationary industrial)
possible possible x (minor) x (minor)
7. Toys, leisure and sports equip-ment
possible possible x (minor) x (minor)
8. Medical devices x possible x (minor) x (minor)
9. Monitoring and control instruments including industrial
x possible x (minor) x (minor)
10. Automatic dispensers possible possible possible x (minor) x (minor)
X…presence of HBCDD
5.1.2 Relevant waste materials/components containing HBCDD
The main application of HBCDD in EEE is the use in HIPS for housings. For the
purpose of the present assessment it is therefore assumed that nearly 100% of
HBCDD used in EEE (i.e. 1,400 tonnes, c.f. Chapter 2) are contained in the ma-
terial stream “plastics”.
Only minor percentages can be expected in the fractions “printed circuit
boards“ and “cables”.
Main materials/
components
Minor materials/
components
ROHS Annex II Dossier for HBCDD
28 Vienna, October 2013
Concentrations of 10 mg/kg HBCDD were measured in printed circuit boards
from small WEEE by Morf et al (2004). Assuming a 3% share of PCBs in EEE
(see Huisman, 2007), the quantity of HBCDD in printed circuit boards derived
from WEEE is estimated to account for 2.8 tonnes20
.
Concentrations of 25 mg/kg HBCDD were measured in copper cables from
small WEEE by Morf et al (2004). Assuming a 2% share of cables in EEE21
the
quantity of HBCDD in cables derived from WEEE is estimated to account for
maximum 7 tonnes20
.
5.2 Waste treatment processes applied to WEEE containing HBCDD
5.2.1 Treatment processes applied
5.2.1.1 Initial treatment processes
Usually the initial treatment of separately collected WEEE of the relevant
HBCDD containing categories (in particular IT&T, UE and large household ap-
pliances) is either manual dismantling or mechanical separation in a shredder
process. The latter may by be performed in large-scale metal shredders22
or in
special shredders dedicated to the treatment of particular types of WEEE.
Manual dismantling allows for separation of rather homogenous material frac-
tions; including plastics housings. Shredder processes are in many cases com-
bined with different types of automated material sorting.
IPTS (2013) refer to a study of ADEME demonstrating a growing trend of WEEE
dismantling during the last few years. EC (2007) estimated an overall number of
WEEE dismantling installations and mixed scrap processors of 1300 in the
EU25.
WEEE ending up in the unsorted municipal waste is likely to be incinerated or
land-filled. In MSW, especially small appliances, which are easily thrown into a
waste bin, are found.
A relevant share of the potential WEEE arising – be it as waste or as “used
goods” - is supposed to be shipped to third countries. These WEEE may un-
dergo dismantling, dumping or any kind of combustion process.
5.2.1.2 Subsequent treatment processes
HIPS components, in particular housings and inner linings, resulting from dis-
mantling of WEEE are assumed to be sent to recycling processes to a major ex-
tent.
20
Based on 9.4 Mio EEE placed on the market in the EU in 2010 (Eurostat) 21
Estimation based on sorting analysis of small WEEE (Salhofer & Tesar, 2011) 22
Often called car shredders
Treatment of
separately collected
WEEE
Treatment of WEEE
ending up in
unsorted MSW
Treatment of WEEE
shipped to third
countries
Recycling of
plastics housings
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 29
The WEEE-Directive requests the separation of flame retarded plastics from
WEEE during their treatment23
.
However, evidence exists, that such a separation is not made comprehensively
and the plastics parts remain unsorted to a large extent. These mixed fractions
are assumed to be exported to third countries (mainly to Asia) to a considerable
extent24
.
According to IPTS (2007) the most common treatment option for styrenics from
housings and inner shelving & linings of cooling appliances consists of several
steps of cleaning and inserts removal, the (automated) identification of poly-
mers/additives and the sorting into regrind compatible fractions for repro-
cessing.
For the purpose of the present assessment it is assumed that HBCDD contain-
ing HIPS mainly derived from dismantling, i.e. large plastic parts including hous-
ings, are subjected to recycling. This includes the processing of waste plastics
by physical means (grinding, shredding, and melting) back to plastic products. It involves cutting, shredding, sorting, separation of contaminants, floating, melt-
ing, extrusion, filtering, pelletizing. Process additives such as curing agents, lub-
ricants and catalysts may be added to improve processing, as well as dyes and
correction agents to re-establish the properties of the plastic in case the original
additives have reacted or decomposed.
Plastics containing fractions resulting from shredding of WEEE as the initial
treatment are usually either:
Land-filled in the form of unsorted shredder residue
incinerated (incineration or co-incineration)
treated in further mechanical treatment processes, including so called Post-
shredder processes
Subsequent treatment of secondary wastes in third countries may be recycling,
dumping or combustion.
5.2.2 HBCDD flows during treatment of WEEE
To evaluate which waste treatment processes are of relevance with regard to
potential HBCDD releases and to estimate these releases, the following scenar-
io for the treatment of HBCDD containing WEEE under current operational con-
ditions was established:
It is assumed that the HBCDD-input into waste management by WEEE corre-
sponds to the total quantity of HBCDD put on the European market via EEE25
,
i.e. 1,400 tonnes annually. Actual WEEE generation at a given time, e.g. based
on models taking into account the life-time of particular equipment, was not
considered for the present assessment.
23
In practice such a separation of flame retarded plastics from mixed WEEE plastics may be per-formed by analysis of the presence of Br using easy to handle techniques (XRF). 24
Personal communication Austrian MoE 25
Based on 9.4 Mio EEE put on the market 2010
Treatment of
shredder residues
Treatment of
secondary wastes
resulting from
WEEE treatment in
third countries
Waste management
scenario for HBCDD
containing WEEE
ROHS Annex II Dossier for HBCDD
30 Vienna, October 2013
To estimate the flows of HBCDD entering particular treatment processes, the
following aspects were taken into account:
the rate of separate collection of WEEE
the rate of (illegal) shipment to third countries
the share of individual treatment processes applied to the relevant waste
streams
The treatment scenario was established on the basis of European WEEE statis-
tics (Eurostat, WEEE data for 2010), assumptions made by EC (2008b) and
own estimations.
WEEE treated in WEEE treatment plants in the EU
44 %26
of the overall WEEE arising27
are treated in WEEE treatment plants in
the EU (i.e. 4.1 Mio t/a).
Taking into account also the composition of WEEE that are reported to be sepa-
rately collected (Eurostat, WEEE- statistics28
) it is assumed that these are com-
posed of:
61% (2.5 Mio t/a) large household appliances (assumed treatment: 80%
shredder process; 20% manual dismantling)
7% (0.29 Mio t/a) small household appliances (assumed treatment: 100%
shredder)
17% (0.7 Mio t/a) IT&T appliances including screens (assumed treatment:
70% dismantling, 30% shredder)
15% (0.65 Mio t) thereof are consumer electronics incl. screens (assumed
30% dismantling, 70% shredder)
Thus for separately collected WEEE an overall share of 71% of shredding and
29% of dismantling are assumed.
WEEE contained in unsorted MSW
13 % of the overall WEEE arising is not separately collected but ends up with
unsorted MSW (i.e. 1.2 Mio t/a).
It is assumed that 2/3 of MSW in the EU are landfilled, 1/3 incinerated29
.
WEEE shipped out of the EU
41 % of the overall WEEE arising (3.9 Mio t) are assumed to be shipped to third
countries.
26
WEEE reported to be collected separately, including also 11% of WEEE (particularly large house-hold appliances) not reported to be separately collected but treated by the same processes as the comparable appliances reported as being separately collected.
27 For the purpose of the present assessment the WEEE arising is seen equal to the amounts put on the market
28 The shares of individual categories in the amounts reported to be separately collected were used
29 See for example EEA (2013)
Assumptions
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 31
WEEE Re-Use
A small share of an estimated 2% of WEEE is assumed to be re-used. This
share is neglected within the present assessment.
Treatment of housings
It is assumed that dismantling results in a complete removal of HBCDD contain-
ing parts, mainly housings.
The whole quantity of the housings derived from manual dismantling of WEEE
is subjected to recycling.
Treatment of shredder residues
It is assumed that the whole HBCDD input into shredders is transferred to
shredder residues.
It is assumed that two thirds of generated shredder residues are landfilled, the
remaining third is incinerated. Recycling of a minor fraction of plastics derived
from shredding is considered to play a minor role.
Taking further into consideration the material composition of WEEE, for exam-
ple as published by HUISMAN ET AL (2007), and using the same estimates for the
quantities of HBCDD in EEE as described in Chapter 2.330
the HBCDD quanti-
ties entering the main treatment processes were estimated (see 13 below).
Table 11: Estimated quantities of HBCDD entering the main treatment processes for WEEE and secondary wastes
derived thereof (in tonnes per year)
WEEE Secondary wastes
Separately collected
WEEE
WEEE in unsorted wastes
WEEE shipped out
of the EU
Large plastic parts (hous-ings) derived from disman-
tling
Shredder residues
Secondary wastes from uncontrolled
WEEE treatment in third coun-tries (incl. )
Re-Use minor (28 tonnes)
Manual dismantling ~179
Shredding (and auto-mated sorting)
~437
Landfilling (EU) ~122 ~ 292
Incineration (EU) ~ 6 ~ 145
Recycling ~ 179
Uncontrolled treatment in third countries (can be dismantling, combustion, dumping, recycling)
~574
30
14% of WEEE plastics are HIPS, 5% of all HIPS contains HBCDD, concentration of HBCDD in HIPS = 7% as a worst case average HBCDD concentration in WEEE = 0.015%
HBCDD input into
WEEE treatment
processes
ROHS Annex II Dossier for HBCDD
32 Vienna, October 2013
5.2.3 Treatment processes selected for an assessment under
RoHS
In order to focus on those processes, where risks for workers or the environ-
ment are most likely to be expected, the following treatment processes were se-
lected for the present evaluation of potential risks:
Mechanical treatment in shredders, because it is applied to HBCDD con-
taining parts of WEEE at several stages in the overall treatment chain at a
large number of installations/locations.
Recycling of HIPS because it is a process applied to plastic parts removed
from WEEE (HIPS-housings) in considerable amounts and recycling of plas-
tics in general is expected to increase in future.
The following treatment processes were NOT selected for a quantitative risk
characterization within this assessment:
Manual dismantling, because - as there is neither a mechanical nor a
thermal treatment releases to air, water and soil are assumed to be low
(specific information on releases from / exposure through manual disman-
tling is not available)
Land-filling, because WEEE or materials derived thereof are not the main
source for HBCDD in wastes usually.
Polymers containing HBCDD will accumulate on landfill sites. Degradation of
the matrix will sooner or later cause release of the substance from the ma-
trix. Besides, bio-degradation of HBCDD occurring in the landfill will limit po-
tential future emissions. HBCDD is regularly found in particulate but also in
dissolved phase of landfill leachate31
. Estimations on overall releases of
HBCDD to the environment from landfills were performed in the context of
the RAR HBCDD (EC, 2008). Occupational exposures to HBCDD at man-
aged landfill sites are likely to be very low (IOM 2009).
Incineration under controlled conditions, because WEEE or materials de-
rived thereof are not the main source for HBCDD in wastes usually.
Furthermore a well-functioning emission control is assumed.
Treatment processes under uncontrolled conditions, because WEEE or
materials derived thereof are not the main source for HBCDD in wastes usu-
ally.
Uncontrolled incineration may result in potential emissions of incineration
residues of unknown chemical composition, which may pose risks for health
and environment at local compartments. If the uncontrolled incineration pro-
cess is done at temperatures below 200°C there is a possibility that HBCDD
containing particles are emitted from the incineration source under uncon-
trolled conditions (Posner et al. 2010).
In case of uncontrolled fires (accidental fire) and at co-combustion at lower
temperatures or not well functioning incinerators there is a risk of formation
of PBDDs and PBDFs (EC 2008, RAR HBCDD).
31
According to DE BOER et al. 2002 particulate phase of leachate in nine Dutch landfills contained 15-22 000 μg HBCDD/l. In the study of FJELD et al. 2005 from landfills in Norway, the concentra-tions in untreated leachate collected from 10 sites were considerably lower with 0.0002-0.15 μg HBCDD/l (UNEP 2011)
Relevant processes
Less relevant
processes
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 33
5.3 Releases of HBCDD from selected WEEE treatment processes
Below information on and estimates of HBCDD releases from the selected
processes are summarized.
5.3.1 Shredding
The most important route of HBCDD from shredding of WEEE or plastics mate-
rials thereof is considered to be via emissions of dust.
Emissions from shredders are typically abated by dust removal in a cyclone and
a wet scrubber. According to the BREF WTI (2006) generic emission levels for
dust (PM) associated to the use of BAT are in the range of 5-20 mg/Nm3. How-
ever, treatment of metal wastes, including WEEE, in shredders has been in-
cluded into the scope of IED-Directive recently. Information on the actual dust
emissions from shredders under current operational conditions is scarce32
.
From EC (2007) estimates of the quantities of diffuse emissions of dust are
available. They estimate an overall annual release of PM10 from European car
shredders of 2,100 tonnes resulting from manipulation of fluff and fines33
.
MORF ET AL (2004) calculated transfer coefficients for HBCDD during treatment
of small WEEE using a combination of dismantling and mechanical treatment34
.
In order to estimate HBCDD releases via diffuse emissions of dust during ma-
nipulating material streams at sites where WEEE are shredded, the following
assumptions were made:
The total input of HBCDD into WEEE shredders was estimated to account
for 437 t/a (compare HBCDD flows in Table 11)
94% of the HBCDD input into a WEEE shredder are transferred to
fluff/fines/dust35
0.1% of fluff/fines/dust are emitted diffusely via PM10 (under dry conditions,
watering of the material and other measures for prevention of diffuse emis-
sions will reduce the percentage by one order of magnitude)
32
Dust concentrations between 1.3 and 18.7 mg/Nm3 for German shredders have been reported
(BDSV, 2012) 33
based on an assumption of 18% generation of fines/dust from materials treated in a shredder and an emission factor of the dry material (g/kg) of 1 g/kg
34 It was found that 28% of the total HBCDD were removed by dismantling of housings of TV and PC screens representing only 3% of the WEEE input, 57% were transferred to a fine plastics fraction representing 20% of the WEEE input, 7% were transferred to a fine metallic fraction, 4% to dusts representing 7% of the WEEE input, 3% in a fraction of Cu-cables and 1% in a fraction of printed wiring boards.
35 Basis for the assumption: Morf et al (2004)
Info on releases
Assumptions
concerning diffuse
emissions
ROHS Annex II Dossier for HBCDD
34 Vienna, October 2013
The overall quantity of HBCDD emissions via diffuse dust emissions from sites,
WEEE are shredded, in Europe is estimated to range from 41.1 kg/a36
to 411
kg/a37
. The actual order of magnitude depends on the degree to which BAT for
preventing diffuse emissions from handling of shredded materials including e.g.
encapsulation of aggregates, wettening of materials etc. is applied.
Having in mind that not all shredders in the EU apply BAT, the estimation of
HBCDD being emitted after de-dusting is based on the upper value for BAT-
AELs, i.e. 20 mg/Nm3. Furthermore, an exhaust air flow of 20,000 m
3/h
38 and a
treatment capacity of 60 tonnes of WEEE per hour39
was assumed.
Furthermore it was assumed that the HBCDD concentration in dust is 60% of
the HBCDD concentration in the WEEE processed40
.
Based on these assumptions41
the total HBCDD releases via residual dust
emissions are about 1.78 kg/a.
In order to estimate the HBCDD releases per installation42
and day the pro-
cessing of WEEE in large-scale metal shredders was used as a reference. The
following assumption was made:
Typical daily WEEE throughput in a large-scale shredder is 250 tonnes43
Based on the resulting daily HBCDD input per installation of 37.7 kg and using
the release factors as illustrated above the following HBCDD releases per in-
stallation and day are estimated:
3.5 to 35.4 g of HBCDD are emitted diffusely
0.15 g of HBCDD are emitted after de-dusting of channeled emissions
In general there is a tendency to further process mixed shredder residues with
the aim to recover valuable metals and also to achieve legally binding recycling
targets. In order to obtain recyclable metal-rich concentrates, several automated
sorting techniques are used. These include also various types of mechanical
treatments, such as shredding, milling, etc., where dust is generated. It is as-
sumed that not all of those installations are equipped with efficient dust preven-
tion techniques. Additional HBCDD releases via dust from processing of shred-
der residues in such installations are likely.
Emissions to water and soil from shredding are considered to be negligible.
36
RFair…0.094 g/kg 37
RFair…0.94 g/kg 38
E.g. described by Ortner (2012) 39
Umweltbundesamt (2008) 40
Morf et al 2004 report a HBCDD concentration in dust of 10 mg/kg compared to 17 mg/kg in the processed WEEE
41 RFair…0.004 g/kg
42 According to EC (2007) there are 220 large scale shredders in the EU-25; taking further into ac-count that WEEE are not only shredded in large scale shredders and
43 Capacities of Austrian ELV-shredders: 25 – 60 t/h, assumption 7 working hours per day
Estimates of diffuse
emissions
Assumptions
concerning
emissions
Estimates of
channeled
emissions
Releases per
installation and day
Further
considerations
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 35
Treatment of WEEE in large-scale metal shredders is a highly automated pro-
cess, where workers primarily manipulate the material outdoors using various
work machines, partly sitting in closed cabins.
Figure 1: Large-scale metal shredder plant (Source: Umweltbundesamt, 2008)
Other mechanical processes where WEEE are treated including e.g. horizontal
cross flow shredders or special drums may be completed by manual sorting of
the disintegrated appliances along a conveyer belt. The air at these indoor work
places may be sucked or not. Usually workers are required to use masks for
prevention of dust inhalation, however, the practical implementation is consid-
ered improvable.
Figure 2: Manual sorting of disintegrated WEEE (Source: Umweltbundesamt, 2008)
For the further mechanical treatment of mixed shredder residues different op-
tions are realized. Installations exist where the – mostly encapsulated – aggre-
gates are operated outdoors or partly encased. Thus material manipulation by
workers is carried out outdoors or in partly encased places with natural ventila-
tion.
Workplace
description
mechanical
treatment of WEEE
ROHS Annex II Dossier for HBCDD
36 Vienna, October 2013
Figure 3: Installation for further treatment of mixed shredder fractions (Source:
Umweltbundesamt, 2008)
Other installations have fully encapsulated grinding and sorting aggregates sit-
uated in a closed building with indoor air extraction. The manipulation of the ma-
terial is carried out both, indoors and outdoors.
5.3.2 Recycling
Comprehensive literature on releases from plastics recycling, such as the
OECD Emission Scenario Document on Plastics Additives44
or the EU RAR on
HBCDD45
point out that the situation regarding recycling of waste plastics is cur-
rently in a state of flux.
According to OECD (2009), the following types of plastics recovery are possi-
ble:
a) The waste plastics may be sold to specialist companies which clean, grind
and market them as clean low grade plastics material. The material may be
classified into polymer type and, at the highest level the materials may be com-
pounded into other polymers/plastics materials and sold as well specified mate-
rials which compete against virgin plastics.
b) The waste plastics may be collected by a specialist manufacturer of plastics
products who, after cleaning and compounding, processes them into a particu-
lar product. Examples of this include the conversion of some waste from large
distributors into plastic film and the use of spent PET bottles to produce polyes-
ter staple fibre for use as insulating filler for clothing etc.
Possible releases of HBCDD during recycling of HIPS-parts (e.g. housings) may
occur in particular through shredding, cleaning, preparation, melting, pelletizing,
transfer and storage and through polymer processing by calendaring, extrusion,
injection moulding etc. to form the final plastic products.
Information on actual releases from such complex process chains is not avail-
able. However, as in many of these processes the thermoplastic material is es-
sentially melted and reused, the release of additives would be expected to be
similar to that which results from the conversion of plastics compounds made
from virgin polymers. According to OECD (2009) it is furthermore not known
whether extra additives are used when recovered plastics articles are used as
the feedstock for new products.
44
OECD, 2009 45
EC, 2008
Info on releases
from HIPS recycling
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 37
For estimation of the releases from recycling of HIPS in the present assessment
the same release factors as applied for estimating the releases from the “For-
mulation of PS compound for the manufacture of EPS and/or HIPS” and from
the “Industrial use of HIPS compound at the manufacture of flame retarded
HIPS” by the RAR for HBCDD were used:
The release factors for emissions from “Formulation of PS compound for the
manufacture of EPS and/or HIPS” as derived by the RAR 46
are as follows:
For water: 0.0076% (0.0053% to surface water 0.0022% to waste water).
For air: 0.0007 %
According to the RAR for “Industrial use of HIPS compound at the manufacture
of flame retarded HIPS” there is no site-specific information available on actual
HBCDD emissions from such processes.
Therefore, the emission factor, L3 (conversion, partially-open processes) from
the Emission Scenario Document on Plastic Additives, ((OECD, 2004)) was
used. For organic flame-retardants this factor is 0.006 %47
.
In this scenario, half of the emission is supposed to go to water as a result of
wet cleaning of surfaces contaminated with HBCDD and HIPS dust spread from
the process (transport, sawing, and cutting). The other half is assumed to be di-
rected to air as a result of HBCDD and HIPS dust spread to the air from the
process and released to the atmosphere via the ventilation. The resulting emis-
sion factors to both water and air are thus 0.003%. The RAR further assumes a
80-%-connection-rate to sewage treatment plants.
Based on a total HBCDD-input into HIPS-recycling processes of 179 t yearly the
following estimates are made:
Formulation of PS compound for the manufacture of EPS and/or HIPS
Total releases to air: 1.3 kg/a
Total releases to waste water: 3.9 kg/a
Total releases to surface water: 9.5 kg/a
Industrial use of HIPS compound at the manufacture of flame retarded HIPS
Total releases to air: 5.4 kg/a
Total releases to waste water: 4.3 kg/a
Total releases to surface water: 1.1 kg/a
In order to estimate the HBCDD releases from recycling per installation and
day the following assumptions were made:
50 installations of an average size are involved in the formulation and use of
recycled HIPS48
each
Operation days per year: 220 (see Guidance Document R.18, plastics recy-
cling sector)
46
According to the RAR several site specific information is available 47
The original reference was not found in the OECD-document 48
Basis for the assumption: IPTS (2013): an overall quantity of 50,000 plastics-converters process-es 46 Mio tonnes plastics,
Assumptions
concerning
emissions
Estimates of total
releases
Estimates of
releases per
installation and day
ROHS Annex II Dossier for HBCDD
38 Vienna, October 2013
Based on these assumptions it is estimated that the HBCDD releases per instal-
lation and day are as follows:
Formulation of PS compound for the manufacture of EPS and/or HIPS
Releases to air: 0.1 g
Releases to waste water: 0.35 g
Releases to surface water: 0.86 g
Industrial use of HIPS compound at the manufacture of flame retarded HIPS
Releases to air: 0.5 g
Releases to waste water: 0.4 g
Releases to surface water: 0.1 g
5.3.3 Summary of releases from WEEE treatment
Table 12: Estimated total HBCDD releases from WEEE treatment processes in the EU (in kg per year)
Air (particulates) diffuse releases
Air (particulates and gaseous)
Water (waste water Water (surface water)
Shredding (and auto-mated sorting)
41.1– 411 1.78
Recycling of HIPS
Formulation of HIPS
1.3 3.9 9.5
Use of HIPS 5.4 4.3 1.1
Total 49,6 - 420 19
Table 13: Estimated local HBCDD releases from WEEE treatment processes in the EU (in g per installation and day)
Air (particulates) diffuse
Air (particulates and gaseous)
Water (waste water Water (surface water)
Shredding (and auto-mated sorting)
3.5 -35.4 0.15
Recycling of HIPS
Formulation of HIPS
0.11 0.35 0.86
Use of HIPS 0.5 0.4 0.1
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 39
6 EXPOSURE ESTIMATION
6.1 Human exposure
Humans are exposed to HBCDD via use of consumer products, indirect envi-
ronmental and/or due to occupational exposure.
Humans might be exposed orally via food, by inhalation of airborne dust or by
dermal contact. According to EFSA, 2011 non-dietary exposure, mainly through
dust in homes, offices, schools, cars and public environment can substantially
contribute, and in some cases even dominate the total human exposure to
HBCDDs, especially for toddlers and other children. Unborn babies may be ex-
posed via blood in the womb and newborns and babies may be exposed via
breast-feeding.
It has been shown that HBCDD is present in human matrices, including human
breast milk, serum samples and adipose tissue (EC, 2008; EFSA, 2011).
Furthermore, an increased temporal trend in breast milk levels between 1980
and 2010 was identified based on studies carried out in Sweden (EFSA, 2011).
In 1980 the mean HBCDD concentration was around 0.08 ng/g fat, while the
levels in 2010 were higher than 0.80 ng/g fat, indicating a 10-fold increase
within the last 30 years.
An overview on HBCDD levels detected in human breast milk worldwide is
given in the supporting document for the draft risk profile on hexabromocyclo-
dodecane (UNEP, 2010b). Time trend analyses from various countries show an
increase in levels in the last decade, as well as higher concentrations in resi-
dents from contaminated sites.
A calculation in the EU Risk Assessment Report (EC, 2008) of HBCDD intake
by breast-fed babies gives the following estimates: 15 ng/kg bw/day for 0-3
months old and 5.6 ng/kg bw/day for 3-12 months old.
According to EFSA (2011) the reported range for total HBCDD in human milk of
0.13-31 ng/g fat results in daily exposures of 0.60-142 ng/kg b.w for breast-fed
infants with average human milk consumption (800 ml per day). For infants with
high human milk consumption (1,200 mL per day) this is 0.90-213 ng/kg b.w,
which is considerably higher than the values reported in 2008 in the EU-RAR.
HBCDD has also been found in human plasma and adipose tissue samples.
The median concentration was generally not higher than 3 ng/g fat (EFSA,
2011).
Within the reviewing of classification of HBCDD it was postulated that at present
the potential of HBCDD to affect child development at the observed exposure
levels is unknown (ECHA, 2010b).
Studies investigating associations of HBCDD contamination levels and adverse
effects on human health are scarce.
In epidemiological studies, no association was found between the levels of
HBCDDs in blood and bone mineral density in an elderly female population, and
between HBCDDs in human milk samples and thyroid-stimulating hormone
(TSH) in neonates (EFSA, 2011).
Routes of exposure
Temporal increase
Contamination of
breast milk
Observations in
humans
ROHS Annex II Dossier for HBCDD
40 Vienna, October 2013
However, according to EFSA, 2011, epidemiological studies of HBCDDs with
suitable estimates of human exposures are required.
6.1.1 Exposure estimates of workers of EEE waste processing
plants
The exposure estimation performed within this assessment is based on the as-
sumptions and calculations provided in the chapter waste treatment and re-
leases of HBCDD (chapter 5.3.).
Within the frame of the process of registration of substances under REACH
several guidance documents and supporting tools for exposure estimation have
been introduced.
One of these tools, the TRA (Targeted Risk Assessment) tool has been estab-
lished and developed by ECETOC to align with the expectations contained in
Chapters R12-R16 of the Technical Guidance on Information Requirements and
Chemicals Safety Assessment by ECHA and is frequently used by industry and
also integrated in the Chesar tool, which is provided by ECHA.
Within this assessment the TRA tool 3.0. has been used to estimate exposure
of workers.
Two scenarios have been selected as relevant regarding exposure due to waste
management operations (see chapter 5.2.).
• shredding of WEEE containing HBCDD, where exposure mainly occurs
through dermal uptake and inhalation of dust (see chapter 5.3)
• recycling of WEEE containing HBCDD, including shredding, cleaning and ex-
trusion
One limitation of the TRA model is that waste treatment processes are not indi-
cated explicitly by the uses and processes which can be selected, as the TRA
tool is intended for industrial processes like manufacture or formulation.
Therefore the most appropriate processes to describe the exposure conditions
of waste treatment processes have been chosen.
6.1.1.1 Exposure estimates: Shredding
As described above no category “shredding” can be selected in the TRA tool. In
order to define comparable exposure conditions the process category 24: “high
(mechanical) energy work-up of substances bound in materials and/or articles”
has been selected. Further description of these processes is given in the
REACH guidance document R.12: “substantial thermal or kinetic energy applied
to substance by hot rolling/forming, grinding, mechanical cutting, drilling or
sanding. Exposure is predominantly expected to be to dust” (ECHA, 2010).
No explanation on the differences of the subcategories 24 a, b, c is given in the
R12 guidance nor in the ECETOC guidance (ECETOC, 2012); therefore all
three subcategories have been selected.
Further selected input parameters: professional use of solid substance with high
dustiness, 8 hours activity (>than 4 hours), outdoors, no respiratory protection
or gloves (dermal PPE - personal protective equipment). Further 100% of sub-
ECETOC TRA
Limitations
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 41
stance in the preparation (>25%) has been applied. The results were then cor-
rected taking into account the calculated average HBCDD content of WEEE
(Chapter 2.3) and information on transfer of HBCDD to dusts from WEEE
shredding (see Chapter 5.3.1). Thus the estimate of an average content of
HBCDD in the dust of WEEE shredders is 0.0084%. In table 14 the results of
the assessment are summarized.
Parameter PROC
Process category
Long-term Inhalative Exposure Estimate
(ppm for volatiles) / (µg/m3 for solids)
Long-term Inhalative
Exposure Es-timate
(µg/m3)
Long-term Dermal Ex-posure Esti-
mate (µg/kg/day)
conc. solid 24a 2100.00 2100.00 2828.57
conc. solid 24b 3500.00 3500.00 2828.57
conc. solid 24c 14000.00 14000.00 2828.57
HBCDD 24a 0.18 0.18 0.24
HBCDD 24b 0.29 0.29 0.24
HBCDD 24c 1.18 1.18 0.24
DNEC/DNEL 9.00 9.00 75.00
*RCR 24a 0.02 0.02 0.0032
*RCR 24b 0.03 0.03 0.0032
*RCR 24c 0.13 0.13 0.0032
Table 14: Results of the ECETOC-TRA model for exposure and risk of shredding
* RCR: Risk Characterization Ratio
The comparison of exposure with hazard leads to the risk characterization. Di-
viding the exposure concentration by the derived hazard value (here: DNEC or
DNEL) gives the risk characterization ratio (RCR): a RCR above 1 indicates a
risk for human health for the mentioned concentration and route of exposure.
By comparison of the derived exposure concentrations with the above prelimi-
nary derived DNELs respectively DNECs it becomes visible, that under the as-
sumptions described previously no risk for workers is expected.
However, taking into consideration that other hazardous substances are present
in the WEEE shredders risk for shredder workers cannot be excluded.
6.1.1.2 Exposure estimates: Recycling
The recycling scenario is based on a series of assumptions and needs to be re-
fined if more specific data are available. Several process categories relevant for
recycling processes (PROC1, PROC 2, (closed process indoors) PROC3,
PROC4, PROC 8a-b (transfer processes), PROC 14 (production) partly with
LEV (local extract ventilation) were selected. A content of <1% of HBCDD in the
preparation was used as input parameter.
This assessment could be refined if further conditions are reported.
Based on these assumptions a risk for workers has been identified. Maximum
RCR (risk characterization ratios) were 4 for long term inhalatory and 9 for long
term dermal exposure.
RCR- Risk
Characterisation
Ratio
Occupational risk
identified
ROHS Annex II Dossier for HBCDD
42 Vienna, October 2013
6.1.2 Monitoring of human exposure at EEE waste processing
plants
No studies on exposure conditions of shredders or HIPS recycling facilities have
been identified.
Exposure in relation to e- waste treatment is mainly reported from Asia and Afri-
ca. Most studies which focus on brominated flame retardants investigated
polybrominated diphenyl ethers, only a limited number also HBCDD.
Higher levels of brominated flame retardants (BFs) in blood samples of workers
at e-waste sites compared to workers exposed via other industrial processes
have been identified (Sjödin et al, 1999, Thomson, 2001, Yang et al. 2013).
One study examined the levels of HBCDD in breast milk of mothers living near
an e-waste region in Vietnam (Tue et al., 2010). Neighbouring residents of one
recycling site were the only group with significant higher levels of HBCDD,
whereas non recyclers in that region as well as neighbouring residents of other
e-waste recycling sites and residents of Hanoi had lower levels. The levels
ranged from 1.4 to 7.6 ng/g lipid wt (recyclers) compared to 0.29 to 1.2 ng/g
lipid wt (non recyclers). Another human bio-monitoring study from Ghana which
is one of the major dumping grounds for electrical and electronic wastes, shows
that HBCDD levels in breast milk from residents of an e-waste contaminated
area are considerably higher compared to non e-waste areas (0.030–3.2
(18*49
)ng/g versus 0.010–0.66 ng/g) (Asante et al. 2011).
Studies show also that the exposure levels through indoor dust and air of work-
ers or neighbouring residents of e-waste plants are higher compared to control
groups (Takigami, et al., 2006, Tue et al., 2010) and also food items are higher
contaminated (Zheng et al., 2012).
It is known that HBCDD as brominated compound can form hazardous degra-
dation and incineration products and contributes to the body burden of those
populations, which are already at risk (Berkely Center, 2012).
Dramatically increases in hazardous degradation products in human blood or
milk have been found in residents of e-waste regions (Berkely Center, 2012).
49
Values from 2004
Third countries
Hazardous
degradation and
incineration
products
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 43
6.2 Environmental exposure
To define the background levels and to evaluate the environmental fate proper-
ties numerous monitoring studies have been conducted in all parts of the world.
The available monitoring data have been summarised within the Stockholm
Convention evaluation to list HBCDD as global POP (UNEP, 2010a) and also in
the EU RAR (EC, 2008).
In general, HBCDD is found widespread in the environment, with very high lev-
els in organism of high trophic levels. HBCDD has been detected in very remote
areas, such as in air in northern Sweden and Finland, far from potential
sources. Therefore, HBCDD is assumed to undergo long-range atmospheric
transport (UNEP, 2010b). Available data from monitoring studies show HBCDD
biomagnification in marine and aquatic food webs. According to recent evalua-
tions the levels are increasing over time, which might be explained due to the
increasing use of HBCDD (EC, 2008, UNEP, 2010b).
According to assessments by Covaci et al. 2006, EC, 2008 and UNEP, 2009
HBCDD is detected at higher concentration levels near point sources (e.g.,
plants producing or pro-cessing HBCDD) compared to areas without obvious
HBCDD sources. Several European hot spots have been identified, such as riv-
ers Viskan (Sweden), Tees and Skerne (UK), Cinca (Spain); and the Western
Scheldt estuary (Netherlands). These areas are related to production of
HBCDD. Covaci et al. (2006) furthermore demonstrates higher contamination
near urban centres and industrial sites.
Table 15: Comparison of HBCDD contaminated vs not contaminated sites in Europe
(adopted from Zhang, 2009; Source: Covaci et al. 2006)
Not contaminated site Contaminated site
Air 2-740 pg/m3 280 -28 500 ng/m
3
Soil n.a 111- 23 200 ng/g dw
Sediment <10 ng/g dw 54-1680 ng/g dw
Aquatic invertebrates 1.3-106 ng/g lw 80-727 ng/g lw
Freshwater fish 12-160 ng/g lw 73-1643 ng/g lw
6.2.1 Exposure estimates for the environment due to WEEE
treatment
EUSES 2.0 has been designed to be a decision-support system for the evalua-
tion of the risks of substances to man and the environment of new and existing
substances and biocides. Within this assessment EUSES 2.1. was used to cal-
culate predicted environmental concentrations, the so called “PECs” for the two
scenarios which have been defined as most relevant: shredding and recycling.
In contrary to the ECETOC-TRA system described previously it is possible to
select the scenario “waste treatment”. However, no applicable emission tables
and no special scenario to be selected are integrated in EUSES so far. There-
fore the results of this assessment have limitations. In order to ensure transpar-
ency are the selected input parameters summarized in Table 16.
Global pollutant
Contaminated sites
EUSES
Limitations
ROHS Annex II Dossier for HBCDD
44 Vienna, October 2013
Table 16: Selected EUSES input parameters
Descriptor input
Assessment mode Interactive
Assessment type Local scale
Additional: Predators exposed via the environment
Physical chemical properties Physical chemical parameters
Chemical class for Koc -QSAR predominantly hydrophobic
Biodegradability Non-biodegradable
Industry category 4: Electrical/Electronic engineering industry
Use category 22: Flame retardants and fire preventing
agents
Use pattern Waste treatment
Fraction of the main local source 0.02
Number of emission days per year 220
6.2.1.1 Exposure estimates: Shredding
Additional input parameters for the shredder scenario are given in table 17. As a
worst case scenario in total 36 g were taken as local emissions to the air as
presented in table 12 chapter 5.3.3. 437 t/a as total input of HBCDD in WEE
shredders was taken as production volume.
Table 17: Selected EUSES input parameters: shredding
Descriptor input
Production volume 437
Fraction of the EU production volume in the region 10
Fraction of tonnage released to air 1 (~100%)
Local emissions to air during episode 0.036 kg (max.)
Local STP input Bypass STP
EUSES Input
parameters
Shredding: Input
parameters
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 45
The derived local PECs are given in table 17 below.
Table 18: Results of environmental assessment using EUSES: shredding
HBCDD concentrations and PECs result unit
Concentration in air during emission episode 6.3 ng/m3
Local PEC in surface water during emission episode (dis-solved)
0.54 µg/l
Annual average local PEC in surface water (dissolved) 0,54 µg/l
Local PEC in fresh-water sediment during emission epi-sode
0,53 mg/kg wwt
Local PEC in seawater during emission episode (dissolved) 0.06 µg/l
Annual average local PEC in seawater (dissolved) 0.06 µg/l
Local PEC in marine sediment during emission episode 0.06 mg/kg wwt
Local PEC in agric. soil (total) averaged over 30 days 1.93 mg/kg wwt
Local PEC in agric. soil (total) averaged over 180 days 1.93 mg/kg wwt
Local PEC in grassland (total) averaged over 180 days 1.93 mg/kg wwt
Local PEC in groundwater under agricultural soil 2.4 µg/l
Further the risk of secondary poisoning has been evaluated; the calculated con-
centrations in fish are summarized in table 18.
Table 19: Results of PECs for secondary poisioning: shredding
HBCDD concentrations and secondary poisoning result unit
Concentration in fish for secondary poisoning (freshwater) 97 mg/kg wwt
Concentration in fish for secondary poisoning (marine) 10.3 mg/kg wwt
Concentration in fish-eating marine top-predators 103 mg/kg wwt
Concentration in earthworms from agricultural soil 10.5 mg/kg
Exposure estimates: Recycling
Table 20: Additional input parameters for the recycling formulation scenario
Descriptor input
Production volume 179
Fraction of tonnage released to air 0.08 (0.11 g)
Fraction of tonnage released to waste water 0.26 (0.35 g)
Fraction of tonnage released to surface water 0.65 (0.86 g)
Local STP input Bypass STP
Shredding: PECs
Shredding: PECs
secondary
poisoning
Recycling: input formulation
ROHS Annex II Dossier for HBCDD
46 Vienna, October 2013
The derived local PECs are given in table 21 below
Table 21: Results of environmental assessment using EUSES: recycling formulation
HBCDD concentrations and PECs result unit
Concentration in air during emission episode 0.03 ng/m3
Local PEC in surface water during emission episode (dis-solved)
0.4 µg/l
Annual average local PEC in surface water (dissolved) 0.4 µg/l
Local PEC in fresh-water sediment during emission episode
0.4 mg/kgwwt
Local PEC in seawater during emission episode (dissolved)
0.05 µg/l
Annual average local PEC in seawater (dissolved) 0.05 µg/l
Local PEC in marine sediment during emission episode 0.045 mg/kgwwt
Local PEC in agric. soil (total) averaged over 30 days 0.07 mg/kgwwt
Local PEC in agric. soil (total) averaged over 180 days 0.07 mg/kgwwt
Local PEC in grassland (total) averaged over 180 days 0.006 mg/kgwwt
Local PEC in groundwater under agricultural soil 0.09 µg/l
Further the risk of secondary poisoning has been evaluated; the calculated con-
centrations in fish are summarized in table 22.
Table 22: Results of PECs for secondary poisoning: recycling formulation
HBCDD concentrations secondary poisoning result unit
Concentration in fish for secondary poisoning (freshwater) 79.5 mg/kg wwt
Concentration in fish for secondary poisoning (marine) 8.16 mg/kg wwt
Concentration in fish-eating marine top-predators 81.5 mg/kg wwt
Concentration in earthworms from agricultural soil 1.01 mg/kg wwt
The scenario: recycling –use is described in the following:
Table 23: Additional input parameters for the recycling use scenario
Descriptor input
Fraction of tonnage released to air 0.5
Fraction of tonnage released to waste water 0.4
Fraction of tonnage released to surface water 0.1
Local STP input Use STP
The derived local PECs are given in table 24 below.
Recycling: PECs
formulation
Recycling:
formulation:
Secondary
poisoning
Recycling: use
input parameters
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 47
Table 24: Results of environmental assessment using EUSES: recycling use
HBCDD concentrations and PECs result unit
Concentration in air during emission episode 0.139 ng/m3
Local PEC in surface water during emission episode (dis-solved)
0.3 µg/l
Annual average local PEC in surface water (dissolved) 0.3 µg/l
Local PEC in fresh-water sediment during emission episode 0,3 mg/kgwwt
Local PEC in seawater during emission episode (dissolved)
0.03 µg/l
Annual average local PEC in seawater (dissolved) 0.03 µg/l
Local PEC in marine sediment during emission episode
0.03 mg/kgwwt
Local PEC in agric. soil (total) averaged over 30 days 0.4 mg/kgwwt
Local PEC in agric. soil (total) averaged over 180 days 0.4 mg/kgwwt
Local PEC in grassland (total) averaged over 180 days 0.4 mg/kgwwt
Local PEC in groundwater under agricultural soil 0.05 µg/l
Further the risk of secondary poisoning has been evaluated; the calculated con-
centrations in fish are summarized in table 25.
Table 25: Results of PECs for secondary poisoning: recycling use
HBCDD concentrations secondary poisoning result unit
Concentration in fish for secondary poisoning (freshwater) 53.6 mg/kg wwt
Concentration in fish for secondary poisoning (marine) 5.55 mg/kg wwt
Concentration in fish-eating marine top-predators 55.4 mg/kg wwt
Concentration in earthworms from agricultural soil 3.12 mg/kg wwt
6.2.2 Monitoring data: WEEE treatment sites/locations
So far, no investigation of a potential HBCDD contamination near European
WEEE treatment plants has been performed.
There are numerous recent investigations- determining the HBCDD contamina-
tion levels from areas near WEEE treatment sites/locations - carried out in de-
veloping countries, mostly China and Vietnam. A summary of the findings of the
monitoring studies is provided in Table 26.
The HBCDD levels measured in soil samples in different Asian countries, China
and Vietnam are in the range of n.d.-2.5 ng/g dw, 0.22-0.79 ng/g dw and 5.4-
400 ng g-1 dw (Gao et al., 2011; Tue et al. 2012, Eguchi et al., 2013).
Soils of e-waste areas have up to 100 fold higher HBCDD exposure levels
compared to reference sites. In particular the e-waste recycling areas of China
and Vietnam have high HBCDD exposure levels (up to 400 ng/g dw) (Tue et al.
2013). The detected HBCDD concentrations are comparable with levels of
HBCDD point sources (producing and formulating plants) in Europe (111-23
200 ng/g dw) (Covaci et al, 2006).
Recycling: use
PECs
Recycling: use
Secondary
poisoning
Developing
countries
Soil
ROHS Annex II Dossier for HBCDD
48 Vienna, October 2013
Only one study is available, in which HBCDD levels in sediments from an e-
waste dismantling site in China are measured. Total HBCDD mean concentra-
tion in sediments is between 4.6 to 35 ng/g dw. The authors state that these
values are higher than those of not obvious exposed areas, in which the levels
are below 10 ng/g dw.
Furthermore, HBCDD contamination has been determined in biota samples.
The highest HBCDD levels were detected in loachs (934- 3529 ng g-1 lipid wt.).
HBCDD concentration ranges varied between 123 - 333 ng g-1 lipid wt, 199-728
ng g-1 lipid wt., nd-1995 ng g-1 lipid wt. for winkles, crucian craps, and different
birds, respectively.
Analyses of birds samples revealed that birds within e-waste areas contain
higher levels of HBCDD (compared to rural areas) (Sun et al., 2012) and HE et
al. (2010) could demonstrate that the birds diet is an important source of
HBCDD exposure.
In developing countries, electrical and electronic appliances containing HBCDD
and other toxic substances are often recycled under conditions which results in
a relatively high release of HBCDD to the environment and contamination of the
sites (Zhang et al., 2009). Open burning and dump sites are common destina-
tions for HBCDD-containing articles and electronic wastes (Malarvannan et al.
2009, Polder et al, 2008c).
It is well known that these processes lead to formation of hazardous transforma-
tion products as polybrominated dioxins and furans, which pose a risk to organ-
isms and accumulate in the food chain.
Aquatic species near WEEE plants in developing countries contain comparable
HBCDDs levels to those from contaminated sites (e.g. HBCDD production sites)
in Europe (Covaci et al. 2006; Wu et al., 2012), which gives a clear indication
that e-waste recycling sites in developing countries are another important
source of HBCDD entry into the environment.
In conclusion, the available monitoring studies clearly indicate higher burden of
HBCDD in soils and sediments as well as in biota in e-waste areas.
Sediments
Biota
Conclusion HBCDD
contamination
developing
countries
RO
HS
Ann
ex II D
ossie
r for H
BC
DD
Vie
nna, O
cto
be
r 20
13
49
Table 26: Monitoring data (environmental compartments, biota, and human diet) from sites near to WEE treatment plants in developing countries
Samples WEEE area; HBCDD concentration range (ng g
-1);
Control area; HBCDD concentration range (ng g-1)
Country Sampling area Remarks Reference
Environment
Soil
Surface soils 2.34-106 (mean range)
1
0.22-0.79 (mean range)1
China E-waste recycling
Highest concentration found in e-waste recycling site (284 ng g
-1 dw)
and total level decreased within the distance from recycling site.
Gao et al., 2011
Soil 5.4-4001
0,99-611 Vietnam E-waste recycling
Significantly higher levels in e-waste recycling areas compared to urban areas
Tue et al., 2013
Soil nd-2.51 nd-1.4
1
Cambodia, India, Indo-nesia, Ma-laysia and Vietnam
Dumping sites -- Eguchi et al., 2013
Sediments
Sediments
4.6-351 <10
1,3 China E-waste dismantling site Higher contamination levels compared
to other areas without known sources.
Zhang et al., 2009
Biota
Winkle, crucian carp, loach
Winkle: 123 - 333
2
Crucian crap: 199-728
2
Loach: 934- 3529
2
Aquatic invertebrates: 1,3-106
2,3
Freshwater fish: 12-160
2,3
China E-waste dismantling site Higher contamination levels compared to other areas without known sources.
Very high concentrations have been detected in loaches.
Zhang et al., 2009
Aquatic species 11-23702 Aquatic invertebrates:
1,3-1062,3
Freshwater fish: 12-160
2,3
China E-waste recycling site Food web magnification has been ob-served
Wu et al., 2012
Different bird spe-cies
nd-50582 na China E-waste region Diet is an important exposure source He et al.,
2010
Passerine birds (muscles)
11-732
2.8-162
China E-waste region E-waste and urban regions are higher contaminated compared to urban site (3.3-1700 ng g lipid wt.(urban) 2.8-16 ng g lipid wt. (rural))
Sun et al., 2012
1dry weight;
2lipid weight,
3comparison with data from literature (Covaci et al., 2006); na: not analysed; nd; not detected
ROHS Annex II Dossier for HBCDD
50 Vienna, October 2013
7 IMPACT ON WASTE MANAGEMENT
7.1 Impacts on WEEE management as specified by Article 6 (1) a
The presence of HBCDD reduces the possibilities of recycling of WEEE plas-
tics.
The main reason therefore is that the use of other brominated flame retardants
in products, including those using recyclates, is already restricted by the RoHS
Directive and/or the POPs Regulation (PBDEs (polybrominated diphenyl
ethers), PBBs (polybrominated biphenyls)).
During the treatment of WEEE the separation of plastics containing brominated
flame retardants is therefore needed - (this is also part of the minimum treat-
ment requirements for WEEE stipulated by the WEEE Directive (2012/19/EU,
Annex VII)).
In practice the separation of plastics containing restricted brominated substanc-
es from mixed plastics are performed using simple screening methods (e.g. X-
ray fluorescence screening, XRF). Plastics are screened for Br to determine
which plastics must not be recycled. It is not possible to distinguish plastics with
HBCDD from plastics with PBDEs (polybrominated diphenyl ethers) or PBBs
(polybrominated biphenyls) already restricted by the RoHS Directive.
When the screening equipment detects brominated plastics the waste treatment
institution must assume, that the plastics contains substances which must not
be recycled and that this plastics must not be recycled. In practice plastics with
HBCDD consequently cannot be recycled, even though the use of recycled
plastics with HBCDD is not restricted in the current RoHS Directive.
If HBCDD was replaced by halogen-free flame retardants, it would be possible
to distinguish the flame retarded plastic parts from plastic parts with restricted
brominated flame retardants by the use of XRF screening, and the plastic parts
may be recycled. The enclosure parts are typically of a size that makes recy-
cling practicable.
Under current operational conditions removal of plastics containing brominated
flame retardants is hardly implemented. The resulting mixed WEEE plastics are
to a considerable extent exported to Asia. Indication is further given, that in the
import countries plastics containing flame retardants, including HBCDD, are not
separated and HBCDD is transferred to recycled plastics, used also in products
which do not need flame retardants, e.g. hair combs. Comparably high recycling
rates for plastics waste in some third countries (e.g. close to 60% India, (EMPA,
2011)) contribute to a long use of HBCDD.
Wastes with a HBCDD content of 0.5% are considered hazardous. The HBCDD
concentrations in WEEE-HIPS were reported to be above this threshold (1-7%
(IOM, 2009)). Taking further into account that about 5 % of HIPS used in WEEE
contain HBCDD an annual quantity of approximately 20,000 tonnes of hazard-
ous HIPS waste would arise.
The only legal options for treating HBCDD containing plastics are to dispose
them in a landfill for hazardous waste or to incinerate them in an expensive
plant for hazardous waste incineration.
Reduced recycling
possibilities
HBCDD remaining in
the recycling loop
Generation of
hazardous waste
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 51
Even in the best European waste collection systems not all WEEE are collected
separately and not all HBCDD containing plastics are removed from other plas-
tics. Under current operational conditions a considerable share of the HBCDD
containing plastics will be incinerated in plants for non-hazardous waste incin-
eration, landfilled, both reducing the life time of the plants and (over time) re-
leasing HBCDD to the environment.
7.2 Estimation of risks for workers and neighbouring residents
No human biomonitoring studies in the neighbourhood of WEEE treatment sites
in Europe have been identified so far. HBCDD has been identified as PBT sub-
stance and will be listed as POP to Annex A of the Stockholm Convention. Al-
though there has been no risk identified for workers under occupational condi-
tions which are expected for shredders, a risk of workers in recycling facilities
cannot be excluded.
In third countries it is documented that HBCDD is detected in higher concentra-
tions near e-waste sites compared to other regions. It has to be taken into con-
sideration that HBCDD contaminates these regions for decades and will con-
tribute to the body burden of the residents in this region and pose a risk to fu-
ture generations.
Main targets for HBCDD toxicity are the liver, thyroid hormone homeostasis, the
reproductive, the nervous and the immune system. The developmental and
neurotoxic potential of HBCDD observed in animal studies gives cause for con-
cern, particularly for unborn babies and young children especially in regions
where the environment is contaminated with this long lasting pollutant.
7.3 Risks estimation for the environment
In case of HBCDD environmental releases have due to its persistency, ten-
dency to accumulate and magnify in the food chain and its toxicity to be mini-
mized anyway. However, in order to assess if the HBCDD exposure of the
herein described scenarios pose a risk to the environment the PEC/PNEC ratios
have been calculated. In general if the ratio of the predicted environmental con-
centration to the concentration which is expected to pose no risk is higher than
1 a risk can be expected and risk reduction measures should take place. In ta-
ble 27 the PEC/PNEC- ratios for the three scenarios are depicted. It can be
seen that a risk can be expected for the aquatic compartment, and for secon-
dary poisoning. Even if the secondary poisoning could be overestimated by
EUSES and also due to the difference of PNECs which are usually given in dry
weight (sediment, soil, fish) whereas PECs are calculated in wet weight it can
be expected that the herein described waste treatment processes lead to a risk
for the environment.
No PNECs are usually derived for the air compartment, but it is known, that
HBCDD can be detected in eggs of terrestrial birds in Europe; increasing con-
centrations have been reported for several marine bird species as well as in
arctic birds-eggs (EC, 2008). Potential for in vivo endocrine disruption of the re-
Contribution to
corrosion in waste
incineration
Europe
Third countries
POP
Risk identified
ROHS Annex II Dossier for HBCDD
52 Vienna, October 2013
productive and thyroid hormonal has been reported on European Flunder (EC
2008).
Table 27: PEC/PNEC ratios for the different scenarios
PECs PNECs PEC/PNEC ratios
shredding rec-form rec-use
Aquatic compartment
PEC surface water 0.31 µg/l 1.7 1.3 0.97
PEC seawater 0.03 µg/l 2 1.6 1
PEC freshwater sediment 0.86 mg/kg dwt
0.6 0,5 0.4
PEC marine sediment 0.17 mg/kg dwt
0.03 0,3 0.17
Terrestrial compartment
PEC soil 5.9 mg/kg dwt
0.3 0.01 0,06
Secondary poisoning
PEC fish (freshwater) 5.0 mg/kg food
20 15.9 10.72
PEC fish (marine) 5.0 mg/kg food
2.06 1.62 1.11
PEC marine predators 20.6 16.3 11.8
PEC terrestrial predators 5.0 mg/kg food
2.1 0.2 0.6
It could be demonstrated that HBCDD is released into the environment by
shredding of WEEE material as well as recycling processes. Due to its high
chronic toxicity to aquatic organisms, the reproductive toxicity to mammals &
birds and the effects on the thyroid-hormone system and the nervous system in
mammals the PNEC for secondary effects in wildlife is exceeded.
Due to the long range transport of this chemical it contributes also to the body
burden of arctic top predators and marine mammals.
PEC/PNEC ratio
Risk identified
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 53
8 ALTERNATIVES
8.1 Availability of substitutes / alternative technologies
Several alternative flame retardants are available to replace HBCDD in HIPS
(SWEREA, 2010, IOM, 2009).
The table below depicts some alternative substances used in HIPS, which in-
clude halogenated flame retardants in conjunction with antimony trioxide (ATO)
and halogen free aryl phosphorus compounds (IOM, 2009). However, some of
these substances possess adverse effects and therefore human health con-
cerns, as well as concerns regarding environmental fate properties and toxic ef-
fects on environmental organisms.
Table 28: Alternative flame retardants for HBCDD used in the production of HIPS (Source: adopted from IOM, 2009)
Substance name CAS number
Human Health concerns
Environmental concerns
Harmonised (HC) and/or self-classification (SC)*
Antimony trioxide
(ATO)
1309-64-4 Potential human car-cinogen and reproduc-tive toxicant.
Not readily biodegrad-able, low to moderate bioaccumulation poten-tial
HC: Carc. 2; SC: Carc. 2; Eye Dam. 1; Acute Tox. 4; Aquatic Chronic 2; Repr. 1A; STOT RE 2; Aquatic Chronic 3; Skin Irrit. 2; Eye Irrit. 2
Decabromodiphenyl ether - DecaBDE (in combination with ATO**)
1163-19-5 Neurotoxicant Not readily biode-gradable, low to mod-erate bioaccumulation potential; On the EU SVHC candidate list identified as substance with PBT** properties
no HC; SC: Acute Tox. 4; Eye Irrit. 2; Muta. 2; STOT RE 2; Aquatic Chronic 4;
Decabromodiphenyl ethane (in combination with ATO**)
84852-53-9 Limited data, but likely to be of low toxicity
Not readily biodegrad-able, may be persistent
no HC; SC: Aquatic Chronic 4
Ethylene bis (tetrabro-mophthalimide) (in comination with ATO**)
32588-76-4 Low toxicity Not biodegradable and is persistent. Non-toxic.
no HC; no SC
Triphenyl phosphate 115-86-6 Chronic toxicant with effects on liver
Readily biodegradable, toxic to aquatic organ-isms
no HC; SC: Aquatic Acute 1; Aquatic Chronic 1; Aquatic Chronic 4 Eye Irrit. 2;
Resorcinol bis
(biphenyl phosphate)
57583-54-7 Chronic toxicant with effects on liver
Inherently biodegrada-ble, may be persistent and bio-accumulative
no HC; SC: Aquatic Chronic 3; Aquatic Chronic 2
Bis phenol A bis
(biphenyl phosphate)
5945-33-5
Limited data, likely to be of low toxicity
Poor biodegradable; not bioaccumulative;
HC: aquatic chronic 4; SC: Aquatic Chronic 4
Diphenyl cresyl
phosphate
26444-49-5 Chronic toxicant with effects on liver, kidney and blood. Effects on fertility
Readily biodegradable; toxic to aquatic organ-ism
no HC; SC: Aquatic Acute 1; Aquatic Chronic 1; Acute Tox. 4; Aquatic Chronic 2; STOT SE 2;
* indicated in the Classification and Labelling (C&L) inventory from ECHA (avail-able at:
http://echa.europa.eu/web/guest/information-on-chemicals/cl-inventory-database);
** toxicological profile of ATO indicated in the first row; **persistence, bio-accumulative and toxic;
Substitutes for
HBCDD in HIPS
ROHS Annex II Dossier for HBCDD
54 Vienna, October 2013
Furthermore, HIPS in EEE can be replaced by several alternative materials, in-
cluding blends of polycarbonate, acrylonitrile butadiene styrene (PC/ABS), poly-
styrene/polyphenylene ether (PS/PPE), polyphenylene ether/high impact poly-
styrene (PPE/HIPS) without flame retardants or with the use of non-
halogenated flame retardants (DEPA, 2010).
Since HBCDD is not widely used in HIPS (only 5%), it is assumed that the al-
ternative flame retardants on the market are technically and economically feasi-
ble (UNEP, 2011).
The available evaluation of IOM 2009 demonstrates that most of the alterna-
tives are not more problematic than HBCDD in regard to human toxicity, but da-
ta for critical endpoints are missing (IOM, 2009).
Based on the available data regarding the hazardous properties we assumed
that co-polymere of HIPS and polyphenylene ether (PPE) in combination with
halogen-free flame retardants as in regard to the toxicological profile as the
most suitable alternative and used this alternative for further socio-economic
impact analysis.
Alternatives for
HIPS in EEE
Conclusion
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 55
9 SOCIO-ECONOMIC IMPACT ANALYSIS
9.1 Approach and assumptions
In accordance with the ECHA (2011) document “Guidance on socio economic
analysis”, the socio-economic analysis of this dossier is based on two scenar-
ios:
In Scenario A the present legislation is not changed and HBCDD may contin-
ue to be used (no ban of HBCDD) in EEE.
In Scenario B the use of HBCDD in EEE is banned. High Impact Polystyrene
(HIPS) in combination with HBCDD is replaced by a co-polymer of HIPS and
Polyphenylene ether (PPE) in combination with halogen-free flame retard-
ants. This is probably the most expensive way of replacing the HBCDD in
EEE. However, it is also the option which should give the highest benefits
with respect to reducing environmental and health impacts.
The major source for the assumptions used in this socio-economic analysis is
DEPA (2010).
Some of the assumptions used in the socio-economic analysis are valid for both
scenarios and thus for the frame assumptions of this analysis. Following as-
sumptions are taken:
The selection of HBCDD or of its alternative does not have an effect on the
life time of the EEE or its usability.
Approximately 20,000 tonnes of HBCDD containing plastics (HIPS) are sold
annually in the EU as part of EEE. These plastics may contain up to 7 %
HBCDD. Consequently up to 1,400 tonnes per year of HBCDD may be con-
tained in the EEE sold in the EU (see chapter 2.3). Thus if HBCDD would be
banned in EEE this may result in the reduction of 1,400 tonnes of HBCDD
consumption annually.
Table 29 summarises the described frame assumptions.
Table 29: Frame assumptions of the Socio Economic Analysis regarding a ban of
HBCDD as flame retardant for EEE (electrical and electronic equipment)
Parameter Assumption
Effect on life time of EEE Negligible effect
Consumption of flame retardant in t/y 1,400
Assumed share of HBCDD in EEE plastics (HIPS) 7%
Total amount of EEE plastics using HBCDD in t/y 20,000
ROHS Annex II Dossier for HBCDD
56 Vienna, October 2013
9.2 Impact on flame retardant and plastics producers
In the following the impact of Scenario B (ban of HBCDD) is compared to Sce-
nario A (no ban of HBCDD) from the point of view of the different stakeholders
along the life cycle.
Three large companies with headquarters in the USA and Israel, but production
facilities in Europe (among other places), dominate bromine production globally
and produce a range of brominated compounds. They also manufacture differ-
ent halogen-free flame retardants like organo-phosphorous compounds and
magnesium hydroxide. These three companies jointly formed the European
Brominated Flame Retardant Industry Panel (EBFRIP) representing these three
main members, as well as a number of major polymer producers as associate
members. These companies are vulnerable to changes in the demand for bro-
minated flame retardants; however, the same companies also manufacture
some of the alternatives.
The manufacturers of alternative flame retardants would benefit from a restric-
tion of HBCDD in EEE. The phosphate esters are manufactured by the same
companies that also provide the brominated flame retardants, but also by at
least two other European companies (DEPA 2010).
Plastic resins are produced and formulated by relatively few large companies in
Europe. The resins are mixed with additives (in so-called “masterbatches”) to
form compounds, which are the raw materials for further processing. Com-
pounding may take place by the resin manufacturer, by specialised com-
pounders or by the company manufacturing the plastic parts.
Whereas the market for compounds is dominated by relatively few large actors,
the market for plastic parts is characterized by many small and medium sized
enterprises (SMEs). In the EU as a whole there are 55,000 companies manu-
facturing rubber and plastics. Of these companies, the average enterprise size
was given as 25 employees. No data are available on how many of these actu-
ally supply EEE parts.
Previous studies have clearly indicated that SMEs are affected to a greater de-
gree by compliance with the RoHS legislation compared to their larger competi-
tors. The relatively larger burden for SMEs holds for total costs to comply with
RoHS in general as well as more specifically the administrative burden. As most
of the SMEs involved in the manufacturing of flame retarded plastics for EEE al-
ready have procedures in place for ROHS compliance, the differences between
the SMEs and larger companies is probably not as large as seen by the initial
implementation of the RoHS Directive. The companies offering the alternative
flame retardants are large companies, and they serve as general customer ad-
visers when it comes to adjusting polymer formulations and production setup,
however, the burden of identification of suitable alternatives and R&D by intro-
duction of new substances must still be expected to place a larger burden on
SMEs than on larger companies (DEPA 2010).
Nevertheless the switch to compounds having less negative environment and
health impacts are regarded as a chance for the European production industry.
In accordance with the Stockholm Convention on Persistent Organic Pollutants,
UNEP (2011) expects that emission reduction measures and use of best prac-
tices will be required in the production and use of HBCD, to reduce HBCD re-
leases to the environment from these uses, if HBCDD is not banned.
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 57
Therefore it is assumed in Scenario A (no ban of HBCDD) that producers of
HBCDD and producers of plastics / plastic products which use HBCDD must in-
stall emission reduction measures and implement best practices. For the sce-
nario calculation it is assumed, that these measures cost at least as much (that
is 10 % more) then the shift from HIPS with HBCDD to HIPS/PPE with halogen-
free flame retardants.
In Scenario B (ban of HBCDD) besides the single HBCDD producer in the EU,
the substitution costs will mainly fall at the formulators and converters of HIPS
(and other plastics),which likely in some cases will include the EEE manufactur-
ers, especially with regard to HIPS housings. The major technical costs are the
costs for more expensive flame retardants, higher loadings of flame retardants
and costs for new moulds. In cases where the total polymer system is changed,
more process steps may need to be changed implying higher costs (but also
higher impact strength as described under available alternatives). The alterna-
tive plasticisers, polymer systems and production set-ups are already devel-
oped and on the market. Costs for mould changes can be reduced significantly
with sufficiently long transition periods, as moulds have to be replaced regularly
in any case (DEPA 2010).
DEPA (2010) estimates that the material price of HIPS containing 7 % HBCDD
as flame retardant is about 2.31 €/kg and of HIPS/PPE containing halogen-free
flame retardants is 3.64 €/kg, so that by a HBCDD ban additional material costs
of 1.33 €/kg of plastics would occur. In addition DEPA (2010) estimates invest-
ment costs of 0.23 €/kg of plastics when switching to a halogen-free system. In
order to switch the 20,000 tonnes of HBCDD containing plastics which are esti-
mated to be used in EU EEE annually (see Table 29) to a halogen-free plastics,
additional material and investment costs of 31.3 Million € occur annually (see
Table 30 below).
When comparing scenario A (no ban of HBCDD) with scenario B (ban of
HBCDD), similar additional costs are assumed, in scenario A for additional
emission abatement equipment as in scenario B for switching to bromine-free
plastics.
With respect to jobs it is expected that the higher turnover of the flame retardant
and plastic industry in Scenario B will create some additional jobs in this sector.
In both scenarios the health impact on the workers of the flame retardant and
plastics industry and the environmental impact are expected to recede, in Sce-
nario A by additional emission reduction measures and in Scenario B by the
ban of HBCDD. While both scenarios may lead to similar results in the EU, from
a ban of HBCDD also the workers and the environment abroad would benefit.
9.3 Impact on EEE producers
Production of EEE is substantial in the EU. However, a large part of the total
end-user consumption of EEE is imported as finished goods from outside the
EU. This is notably the case for small household appliances, consumer elec-
tronics, IT equipment, and toys etc., but also for other EEE groups.
As the service of the plastic used in EEE does not change when switching from
HBCDD as flame retardant to HIPS/PPE with halogen-free flame retardants, no
major effect is expected for the EEE producers. The higher costs of the plastics
ROHS Annex II Dossier for HBCDD
58 Vienna, October 2013
occur for all EEE producers selling to the EU market. Thus no change in the
relative competitive position of the different EEE producers is to be expected
from a HBCDD ban.
As compared to the turnover of the EU electrical engineering industry of 411 bil-
lion € in 2008, the additional costs of 31.3 million € (+0.008 %) is so small that
no influence on the market needs to be feared. In any case additional costs are
to be expected with and without the ban.
9.4 Impact on EEE users
The major impact on EEE users, is the additional costs which are to be borne
by the EU industrial and private consumers. It is to be expected that a some-
what higher price of the EEE draws on the competitive position of the European
industry as a whole causing some jobs to be lost. On the other hand, jobs are
created as an essential part of the additional costs are spent for the benefit of
European plastic producers and environmental industry.
In any case additional costs are to be expected for both scenarios, with and
without a ban of HBCDD. As the amount of the additional costs should be simi-
lar in both cases, the ban of HBCDD should not be more expensive than the op-
tion of staying with the HBCDD.
With respect to the benefits, however, there is a difference between the scenar-
ios. In rare cases EEE start to glow or burn. Then an EEE which does not con-
tain bromine can be expected to be less harmful to the user of the EEE than an
EEE which contains HBCDD.
9.5 Impact on waste management
For details on impacts of HBCDD in EEE on waste management refer to Chap-
ter .7
In total the benefits for the waste management sector of banning HBCDD in
EEE can be summarized as:
Reduced environmental and health impacts (Increased recycling potential
Reduced corrosion of waste incineration plants
For the waste management sector no substitution costs occur, as with the exist-
ing equipment bromine-free plastics can even be treated better than HBCDD
containing plastics.
9.6 Impact on administration
According to DEPA (2010) extra compliance costs related to the addition of one
new substance under RoHS are expected to be minimal for companies which
have already implemented RoHS, that is, for most companies which are rele-
vant for this analysis. HBCDD is typically used in parts where deca-BDE have
traditionally also been used and compliance documentation would usually be
required for such parts.
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 59
The main extra costs are estimated to be related to control; both by the manu-
facturers, importers and the authorities. The presence of HBCDD cannot be de-
termined by simple XRF screening (only the presence of Br), therefore sam-
pling, extraction and laboratory analysis is required. As the parts that may con-
tain HBCDD typically may also contain other RoHS substances the extra costs
would mainly comprise the costs of analysis as the sampling and sample prepa-
ration would in any case be undertaken for control of other RoHS substances in
the parts.
The administrative costs for Scenario B (ban of HBCDD) are estimated as fol-
lows:
DEPA (2010) estimates that the additional costs for proving that the produced
plastics is HDPCC free is 30 €.
The UK Risk Reduction Strategy and Analysis of Advantages and Drawbacks
of Octa-BDE (Corden and Postle, 2002) reports that there are 55,000 com-
panies manufacturing rubber and plastics in the EU. When assuming that on
the average two test samples have to be provided by company and year,
proving that the produced plastics is HDPCC free the total administrative
costs for the EU are 3.3 million €/year.
But also in Scenario A (no ban of HBCDD) additional administrative costs occur.
As explained above, in this scenario emission reduction measures are required.
Public administration is required to keep control that these measures are effec-
tive. For the scenario analysis it is assumed, that the costs for monitoring the
emission reduction measures are as high as the costs for monitoring a HBCDD
ban.
In both scenarios, however, the administrative costs are not lost costs, as they
increase the turnover of the chemical analysis industry.
9.7 Total socio-economic impact
When comparing the costs of the Scenario A (no HBCDD ban) with the costs of
a Scenario B (with HBCDD ban) it is expected, that:
Without a ban of HBCDD flame retardant and plastics producers will have to
invest in additional emission reduction measures
With the ban of HBCDD flame retardant and plastics producers will have to
deal with higher material costs and investments in new moldings.
In total the costs should be about the same in both scenarios (see Table 30)
Also in both scenarios the total effect on jobs is expected to be neutral. While
some jobs are lost in the industries using EEE, some jobs are created with
flame retardant/plastic producers and the environmental industry. In any case,
also with respect to jobs the difference between the 2 scenarios and thus the ef-
fect of a HBCDD ban should be very small.
With respect to the benefits, however, the difference between the two scenarios
is big. While the implementation of emission reduction measures in scenario A
provides only for a better protection of the workers in and the environment
ROHS Annex II Dossier for HBCDD
60 Vienna, October 2013
around the flame retardant / plastic production sites in Europe a ban of HBCDD
generates following additional benefits:
Increase in the competitive position of environmentally friendly industry
Globally reduced environmental and health impacts during HBCDD and plas-
tics production
Reduced environmental and health impacts during especially waste phase
Reduced corrosion of waste incineration plants
Reduced generation of hazardous waste
Increased recycling potential of plastics
In total the ban of HBCDD creates no additional costs as compared to a non-
ban scenario while creating substantial additional benefits for health, environ-
ment and economy.
Table 30: Scenario Management Tableau of the Socio Economic Analysis regarding a ban of HBCDD as flame
retardant for EEE (electrical and electronic equipment)
Scenario A – no ban of HBCDD
Scenario B – ban of HBCDD
Difference of Sce-narios (B-A)
Material used for EEE plastics HIPS with HBCDD as flame retardant
HIPS/PPE with halo-gen-free flame retar-dants
Additional raw material costs of plastic mate-rial in €/kg
0 1.33 1.33
Additional investment costs for changing to other plastic material in €/kg plastic material
0 0.23 0.23
Additional raw material + investment costs for EEE HBCDD plastics or its alternative in €/kg
0 1.56 1.56
Additional raw material + investment costs for EEE HBCDD plastics or its alternative in €/y
0 31,300,000 31,300,000
Additional costs for HBCDD and plastic pro-ducer for emission reduction measures and use of best practices in €/y
34,300,000 0 -34,300,000
Additional costs for EEE producer in €/y 0 0 0
Additional costs for waste treatment in €/y 0 0 0
Additional administrative costs in €/a 3,300,000 3,300,000 0
Total additional costs for final consumers 37,600,000 34,600,000 -3,000,000
Benefits Increase in the com-petitive position of environmentally friendly industry
Increase in the com-petitive position of environmentally friendly industry
Reduced environ-mental and health impacts during HBCDD and plastics production in the EU
Global reduced envi-ronmental and health impacts during HBCDD and plastics production
Reduced environ-mental and health im-pacts during HBCDD and plastics produc-tion also abroad
Scenario A – no ban of HBCDD
Scenario B – ban of HBCDD
Difference of Sce-narios (B-A)
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 61
Reduced environ-mental and health impacts during use and especially waste phase
Reduced environ-mental and health impacts during use and especially waste phase
Reduced corrosion of waste incineration plants
Reduced corrosion of waste incineration plants
Increased recycling potential
Increased recycling potential
ROHS Annex II Dossier for HBCDD
62 Vienna, October 2013
10 RATIONALE FOR INCLUSION OF THE SUBSTANCE IN ANNEX II OF ROHS
Hazardous potential
Nature and reversibility of the adverse effect
HBCDD is persistent and undergoes long range transport; it accumulates in the food chain, is reprotoxic and accumulates in human breast milk.
HBCDD releases from WEEE treatment
The relevant releases of HBCDD from shredding of WEEE and recycling of
HIPS-parts derived from WEEE are releases to the air. The same is true for the
treatment of other post-consumer wastes50
.
The RAR for HBCDD (EC, 2008) identifies EPS and XPS insulation boards as
the most relevant post-consumer waste streams. Regarding the actual releases
of HBCDD from demolition of buildings there is generally a big uncertainty de-
pending very much on the techniques used for demolition. Nevertheless rough
estimates for HBCDD releases from insulation boards are provided by the RAR.
Based on an annual consumption of 8,000 tonnes of such insulation boards in
the EU, releases during waste management were estimated to account for 108
kg/a for a 30% share of boards being recycled after manual removal from build-
ings plus an estimated 5,600 kg/a resulting from demolition of buildings contain-
ing the remaining 70% of EPS/XPS boards. Releases from further waste man-
agement operations were not estimated.
In a scenario where emissions of dust at shredder plants are prevented to a
high extent, HBCDD releases via particulates from WEEE treatment are compa-
rably low: 43 kg/a.
In a scenario where only little measures for preventing dust emissions from
shredder plants are taken, the estimated releases from mechanical treatment of
WEEE are 413 kg/a, which is considerably higher than the emissions from
manually removed EPS/XPS boards.
Taking into account that material streams derived from WEEE may be sub-
jected to mechanical treatment processes several times during the overall
treatment chain, it is expected that the actual releases might even be higher.
HBCDD releases to air and waste water from recycling of WEEE-HIPS parts,
each approximately 25.7 kg/a, are estimated to be lower than releases from
mechanical treatment of WEEE.
In any case, overall releases from WEEE treatment (compare Table 12) are ex-
pected to be far lower than the releases estimated to arise from EPS/XPS con-
taining demolition boards (5,780 kg/a from recycling and demolition of buildings
in a worst case scenario).
50
In general RAR HBCDD provides little information on releases of HBCDD containing products af-ter they became waste.
WEEE treatment
compared to
treatment of other
post-consumer
wastes
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 63
Compared to the overall releases of HBCDD to air other than those resulting
from waste management activities estimated in the RAR for HBCDD (i.e. 508
kg/a; see Table 31 below) the releases from WEEE treatment are either in the
same order of magnitude (420 kg/a) or down to one order of magnitude lower
(50 kg/a), when measures for prevention of dust emissions are taken.
Releases into waste water from WEEE treatment are expected to be of little
relevance (19 kg/a) compared to the total HBCDD releases to waste water
(6,251 kg/a) and surface water (1,933) as estimated in the RAR (see Table 31
below).
In addition releases of HBCDD are also expected from landfills, incineration
plants and uncontrolled treatments of WEEE.
Table 31: Summary of HBCDD releases (Source: Table 3-34 of the RAR for HBCDD,
EC, 2008)
Releases from
WEEE treatment
compared to total
HBCDD releases
ROHS Annex II Dossier for HBCDD
64 Vienna, October 2013
Risk for human health
A risk for workers is expected in facilities where HBCDD containing plastic
parts from WEEE are recycled.
Based on an estimated number of 50 installations where HBCDD-containing
plastics are processes/recycled and taking into account an average of 25 em-
ployees in the plastics processing sector the number of affected workers is es-
timated to account for 1,250.
Shredding, applied outdoors, is considered to be of lower health relevance.
However workers might be at risk because they are exposed to a mixture of
hazardous substances contained in shredder dust. Even if the risk characteriza-
tion ratio is below 1, the safety margin is in some cases below the factor of ten.
Based on an estimated number of 450 installations in the EU where WEEE and
materials derived thereof are treated mechanically and assuming 5 to 15 work-
ers per installation51
, the estimated range of workers exposed to HBCDD re-
leases ranges between 2,250 to 6,750.
Considerable higher risk is expected due to uncontrolled treatment in third
countries. Neighbouring residents of waste treatment sites are also at risk due
to hazardous degradation and incineration products. Especially risks for
unborn and breast fed children have been identified and health effects have
been reported.
Exposure of the environment
For shredding of WEEE and recycling of HIPS the environmental exposure was
estimated from the calculated HBCDD releases using the EUSES. 2.1 system
for evaluation of substances. Comparable with other industrial processes local
HBCDD concentrations at sites where WEEE are shredded and HIPS is recy-
cled are more than one order of magnitude higher than background concen-
trations.
Monitoring data from third countries demonstrate the long-lasting contamina-
tion of the environment due to WEEE treatment.
Risk for the environment
For shredding of WEEE52
and recycling of HIPS53
, a risk for the aquatic com-
partment as well as for secondary poisoning for the aquatic, marine and
terrestrial compartment has been identified. The major concern is that accu-
mulation of such substances in the food chain presumable result in adverse ef-
fects in the long term. Especially top predators are at risk due to the burden of
persistent organic pollutants. In the environment HBCDD is part of a mixture of
persistent organic pollutants which is toxic in many cases and endangers espe-
51
Estimation based on Umweltbundesamt (2008) 52
Involved number of sites: at least 450 53
Involved number of sites: 50
Workers in plastics
recycling
Workers in
mechanical
treatment of WEEE
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 65
cially sensitive and endangered species and affects sensitive stages of de-
velopment.
Main influencing factors within the assessment
Regarding the establishment of the waste management scenario and determi-
nation of environmental releases there are 2 major factors:
The annual quantities of HBCDD actually contained in the collected WEEE
are influenced by various factors, including the actual HBCDD put on the Eu-
ropean market via EEE, the lifespan of EEE, the actual WEEE collection
amounts.
The degree of application of measures for preventing diffuse emissions when
handling materials derived from shredded WEEE is considered to have a
considerable impact on the estimated HBCDD emissions. However, there is
no information available on the actual implementation of such measures.
Within the risk assessment approach the two evaluation tools ECETOC TRA
and EUSES were used. As these are not yet aligned to evaluate waste expo-
sure scenarios because no process categories, emission tables and special
scenarios are integrated, appropriate scenarios were defined, emissions and re-
leases calculated and then used as input parameters for EUSES.
Impact on waste management
The extent to which material recycling/recovery is affected:
Under current operational conditions the presence of Br is determined to decide
whether it is allowed to recycle WEEE-plastics or not. HBCDD thus reduces the
possibilities WEEE plastics recycling as it is not distinguishable with routine de-
tection methods from other brominated flame retardants.
The extent to which HBCDD remains in the recycling loop
In practice removal of plastics containing brominated flame retardants is hardly
implemented. Indication is given that especially in third countries plastics con-
taining flame retardants, including HBCDD, are not separated and HBCDD is
transferred to recycled plastics, used also in products which do not need flame
retardants, e.g. hair combs. In those countries high recycling rates are realized.
The amount of hazardous waste which is generated in the course of
processing WEEE
Wastes with a HBCDD content of 0.5% are considered hazardous. Assuming
separation of all plastics containing more than 0.5% HBCDD the amounts of
HBCDD used in EEE would lead to an annual quantity of up to 20,000 tonnes of
hazardous plastics waste.
Other negative impacts on waste management
In waste incineration plants HBCDD containing plastics contribute to corrosion
increasing treatment costs and lowering the life-time of the plants.
ROHS Annex II Dossier for HBCDD
66 Vienna, October 2013
Available Alternatives
The availability of substitutes/alternatives with less negative properties
Both is available, substitutes for HBCDD in HIPS and alternatives for HIPS in
EEE. These include also substances with lower hazardousness compared to
HBCDD, in particular p-based flame retardants.
Technical and economical feasibility of the alternative substance
Since HBCDD is not widely used in HIPS (only 5%), it is assumed that the al-
ternative flame retardants on the market are technically and economically feasi-
ble (UNEP, 2011).
Socio-economic impact analysis
In total the ban of HBCDD creates no additional costs as compared to a non-
ban scenario (which requires investments in emission reduction measures)
while creating substantial additional benefits for health, environment and econ-
omy.
The costs of a potential restriction of HBCDD (higher material costs and invest-
ments in new moldings for the producers) in EEE compared to no action (costs
for additional emission reduction measures) are considered to balance each
other. Also in both scenarios the total effect on jobs is expected to be neutral.
With respect to the benefits the difference between the two scenarios is big.
While the implementation of emission reduction measures in scenario A pro-
vides only for a better protection of the workers in and the environment around
the flame retardant / plastic production sites in Europe a ban of HBCDD (sce-
nario B) generates following additional benefits:
Globally reduced environmental and health impacts during HBCDD and plas-
tics production
Reduced environmental and health impacts during use and especially waste
phase
Reduced corrosion of waste incineration plants
Increased recycling potential of plastics
ROHS Annex II Dossier for HBCDD
Vienna, October 2013 67
Draft Conclusion:
It is recommended to include HBCDD in Annex II to the RoHS-Directive be-
cause:
a risk for the environment caused by both, shredding of WEEE and recy-
cling of HBCDD containing HIPS, is expected: for the aquatic compartment
and for secondary poisoning
a risk to human health of workers involved in the recycling of HBCDD con-
taining plastics is expected
a risk for neighboring residents is expected, especially in third countries
the overall releases from the relevant WEEE treatments are a relevant
contributor to the total HBCDD releases to air
there are several negative impacts on the waste management (reduced
recycling possibilities for WEEE plastics, generation of considerable amounts
hazardous wastes, corrosion in incineration plants where HBCDD containing
plastics are processed, stays long in the recycling loop)
alternatives with less negative properties are available and technically and
economically feasible, in particular P-based flame retardants
the socio-economic analysis revealed no additional costs but several benefits
from restriction of HBCDD in EEE
For the maximum concentration of HBCDD to be tolerated in homogenous
materials in EEE it is proposed to set the same value as defined for POPs
waste by Annex IV to the EU POPs Regulation (850/2004/EC) for most POPs,
i.e. 0.005 %.
ROHS Annex II Dossier for HBCDD
68 Vienna, October 2013
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ROHS Annex II Dossier for HBCDD
74 Vienna, October 2013
12 ABBREVIATIONS
ABS .................... acrylonitrile butadiene styrene
BMD ................... Bench mark dose
CLP .................... Classification, packaging and labelling
DecaBDE .......... Decabrominated diphenylether
DNEL ................. Derived no effect level
EEE ................... Electrical and electronic equipment
HBCDD ............. Hexabromocyclododecane (same as HBCD)
HIPS .................. High impact polystyrene
LOAEL(s) ........... Lowest observed adverse effect levels
MSW .................. Municipal solid waste
NOAEC .............. No observed adverse effect concentration
NOAEL(s) .......... No observed adverse effect levels
PC ...................... Polycarbonate
PBT .................... Persistent, bioaccumulative and toxic
PEC .................... Predicted effect concentration
PNEC ................. Predicted no effect concentration
POP ................... Persistent organic pollutant
PVC ................... Polyvinyl chloride
PP ...................... Polypropylene
PPE ................... Polyphenylene ether
RAC ................... Risk assessment committee
RAR ................... Risk assessment report
REACH .............. Registration, Evaluation, Authorisation and Restriction of Chemicals
SMEs ................ Small and medium sized enterprises
WEEE ................ Waste electrical and electronic equipment
XRF ................... X-ray fluorescence screening,
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13 LIST OF TABLES
Table 1: Substance identity and composition (Source: ECHA, 2009) ............. 5
Table 2: Physico-chemical properties of HBCDD (Source: ECHA, 2009) ....... 7
Table 3: Harmonized classification of HBCDD1 ............................................... 9
Table 4: Examples of developmental and repeated-dose toxicity studies
(cited in EC, 2008 and ECHA, 2008, EFSA, 2011) .......................... 17
Table 5: Preliminary (not by technical committees reviewed) derived no
effect levels (DNELs) deduced for the present assessment ............ 21
Table 6: Persistent organic pollutant (POP) characteristics of HBCDD ........ 23
Table 7: Environmental parameters in comparison with PBT1 and POPs
2
criteria .............................................................................................. 23
Table 8: Outcome of eco-toxicity studies (Source: EC, 2008) ....................... 24
Table 9: Deduced predicted no effect concentrations (PNECs) for
different compartments (Source: EC, 2008) .................................... 26
Table 10: Presence of HBCDD in the 10 WEEE categories as specified by
Annex I to the WEEE Directive (Source: DEPA, 2010, adapted
by Umweltbundesamt) ..................................................................... 27
Table 11: Estimated quantities of HBCDD entering the main treatment
processes for WEEE and secondary wastes derived thereof (in
tonnes per year) ............................................................................... 31
Table 12: Estimated total HBCDD releases from WEEE treatment
processes in the EU (in kg per year) ................................................ 38
Table 13: Estimated local HBCDD releases from WEEE treatment
processes in the EU (in g per installation and day) ......................... 38
Table 14: Results of the ECETOC-TRA model for exposure and risk of
shredding ......................................................................................... 41
Table 15: Comparison of HBCDD contaminated vs not contaminated sites
in Europe (adopted from Zhang, 2009; Source: Covaci et al.
2006) ................................................................................................ 43
Table 16: Selected EUSES input parameters .................................................. 44
Table 17: Selected EUSES input parameters: shredding ................................ 44
Table 18: Results of environmental assessment using EUSES: shredding .... 45
Table 19: Results of PECs for secondary poisioning: shredding ..................... 45
Table 20: Additional input parameters for the recycling formulation
scenario ............................................................................................ 45
Table 21: Results of environmental assessment using EUSES: recycling
formulation ....................................................................................... 46
Table 22: Results of PECs for secondary poisoning: recycling formulation .... 46
Table 23: Additional input parameters for the recycling use scenario ............. 46
ROHS Annex II Dossier for HBCDD
76 Vienna, October 2013
Table 24: Results of environmental assessment using EUSES: recycling
use .................................................................................................... 47
Table 25: Results of PECs for secondary poisoning: recycling use ................ 47
Table 26: Monitoring data (environmental compartments, biota, and
human diet) from sites near to WEE treatment plants in
developing countries ........................................................................ 49
Table 27: PEC/PNEC ratios for the different scenarios ................................... 52
Table 28: Alternative flame retardants for HBCDD used in the production
of HIPS (Source: adopted from IOM, 2009) ..................................... 53
Table 29: Frame assumptions of the Socio Economic Analysis regarding
a ban of HBCDD as flame retardant for EEE (electrical and
electronic equipment) ....................................................................... 55
Table 30: Scenario Management Tableau of the Socio Economic Analysis
regarding a ban of HBCDD as flame retardant for EEE
(electrical and electronic equipment) ............................................... 60
Table 31: Summary of HBCDD releases (Source: Table 3-34 of the RAR
for HBCDD, EC, 2008) ..................................................................... 63
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14 LIST OF FIGURES
Figure 1: Large-scale metal shredder plant (Source: Umweltbundesamt,
2008) ................................................................................................ 35
Figure 2: Manual sorting of disintegrated WEEE (Source:
Umweltbundesamt, 2008) ................................................................ 35
Figure 3: Installation for further treatment of mixed shredder fractions
(Source: Umweltbundesamt, 2008) ................................................. 36