COMMENTS ON AN ANNEX XV DOSSIER FOR IDENTIFCATION OF A SUBSTANCE AS SVHC AND RESPONSES TO THESE COMMENTS

Substance name:	bis(pentabromophenyl) ether  [decabromodiphenyl ether; decaBDE]	
CAS number:	1163-19-5	
EC number:	214-604-9	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: PBT/vPvB

Disclaimer: Comments provided during public consultation are made available in this document as submitted by the commenting parties. It was in the commenting parties own responsibility to ensure that their comments do not contain confidential information. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a Substance of Very High Concern. The table does not contain any confidential information.

PART I: Comments and responses to comments on the SVHC proposal and its justification

General comments on the SVHC proposal
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
26	2012/10/18	Industry or trade association
Aerospace Industries Association
United States	See attached document	Thank you for your comments. This information can be taken into account during the prioritisation process if this substance is added to the Candidate List.	
			See also:
Comment 26 attachment (ECHA deca SVHC consultation oct 18 2012.docx).docx		
25	2012/10/18	National NGO
Action For Breast Cancer Foundation
Malta	We support the nomination of this chemical to the Candidate List as a substance of very high concern’	Thank you for your support.	
24	2012/10/18	Member State
Norway	We would like to thank UK for preparing this comprehensive document. 
The Norwegian CA supports that decaBDE (CAS Number: 1163-19-5) should be identified as a substance of very high concern and should be included in the Candidate List based on the evidence that decaBDE is a PBT/vPvB-forming substance in accordance with Annex XIII of REACH, thereby fulfilling the criteria in Articles 57(d) and (e). 
The evidence that decaBDE debrominates under environmentally relevant conditions to persistent, bioaccumlative and toxic BDE congeners and the widespread occurrence of decaBDE in the environment, including in the Arctic, and the presence in tissues of top predators (including sensitive life stages such as eggs) is of very high concern. 
Convincing evidence on debromination of decaBDE under environmentally relevant conditions is presented in the Annex XV report. New data with evidence of debromination of decaBDE are published continuously. We would only like to point to some additional recent publications (see specific comments on part I justification) that, by analysis of BDE-congeners including some "marker congeners" of debromination, further prove that such reactions occur in nature. 
Concerning use investigations by Norwegian Authorities have identified some products that are still on the market where DecaBDE has been added in the adhesive layer of reflective tapes on work wear which are used as fire fighter uniforms, by the staff at oil platforms, in the energy sector etc . The reflective tapes contained decaBDE from 1 to 5 % (weight % of reflective material. 
This use in adhesive in the reflective tapes on some work wear has been shown to lead to significant emissions of decaBDE to the aquatic environment. The use was detected through investigations that were made in order to identify the source of some hot spot contaminations of decaBDE in sediments in a Norwegian fjord and reflective tapes on some work wear garment brands was identified as a potential source. Migration tests indicate that 10-30% of the flame retardant is lost over the service life of the reflective tape. For further information see specific comments on part II use and exposure. 	Thank you for the additional information. We have addressed specific studies in our response later on. The information on presence in textiles is interesting and can be taken into account during the prioritisation step if the substance is added to the Candidate List.	
23	2012/10/18	International NGO
Health and Environment Alliance
Belgium	We are very pleased to finally see this dossier having been put forward by the UK, and fully support the adoption of DECA on the basis of its PBT properties to the Candidate List.	Thank you for your support.	
22	2012/10/18	Industry or trade association
GIFAS
France	please refer to attached letter	Thank you for your comment. This information can be taken into account during the prioritisation process if this substance is added to the Candidate List.	
			See also:
Comment 22 attachment (20017_2012_Echa_54 SVHC consultation.pdf).pdf		
21	2012/10/18	European institution
European Chemicals Agency
Finland	According to Annex XIII of REACH (cf. Recital 10 of Commission Regulation (EU) No 253/2011 and the introduction part of Annex XIII), since substances can transform or degrade into products with PBT or vPvB properties, the identification of PBT and vPvB substances ‘(…) shall also take account of the PBT/vPvB-properties of relevant constituents of a substance and relevant transformation and/or degradation products’. In this context and based on all the evidence provided in the Annex XV report, decaBDE should be considered as a PBT/vPvB substance. Consequently, please consider changing the wording used in the report for the identification of decaBDE from e.g. “PBT/vPvB-forming substance” to “PBT/vPvB substance”.	The edit has been made as suggested.	
20	2012/10/18	Industry or trade association
European Flame Retardants Association
Belgium	Summary

We consider that no significant environmental or health risks have been demonstrated in the case of DecaBDE. The REACH Guidance on the issue of transformation products is ambiguous with respect to timescales and rate of formation. Applying such guidance verbatim to DecaBDE risks creating a precedent whereby Annex XIII is interpreted to imply that formation of even trace amounts of degradation products meeting the PBT/vPvB criteria would automatically lead to a compound being classified as a Substance of Very High Concern.

General Comments

The Annex XV dossier, dated August 2012, considers DecaBDE to meet the definition of PBT according to Article 57(d) and as vPvB according to Article 57(e). As discussed in detail in Chapter 3 of the dossier, the substance DecaBDE is not considered to meet these criteria but the Annex XV dossier claims that “there is a high probability that DecaBDE is transformed in the environment to form substances which themselves have PBT/vPvB properties, or act as precursors to such substances, in individual amounts greater than 0.1% w/w over timescales of a year.” We think this conclusion is 

a) not justified based on fundamental grounds, and 
b) not supported by the actual weight of evidence.

As acknowledged in the Annex XV dossier, the criteria for considering precursors to PBT/vPvB substances as PBT/vPvB themselves are unclear. Annex XIII of the REACH Regulation, which specifies the criteria for identifying PBT/vPvB substances, does not specify a rate of degradation or a threshold from which formation of PBT/vPvB substances should be considered relevant. The ECHA Guidance for the preparation of Annex XV dossiers is not much clearer and stipulates that an Annex XV dossier can be considered for “a substance that degrades or is transformed into substances which have PBT or vPvB properties or properties of equivalent concern and if these are present in individual amounts at or above 0.1% (of the weight of the initial substance)”. Whether or not this 0.1% threshold is reached will obviously depend on a number of factors, such as the timeframe considered (does one need to consider 28 days, 1 year, or longer), the environmental conditions and the actual amounts of the substance. Also, it makes a difference whether such data are generated in the laboratory (often under ‘enhanced conditions’) or if relevant degradation needs to be demonstrated in field studies. Neither of the above points are specified in the REACH Regulation and therefore a conclusion whether or not a substance meets the definition of a PBT/vPvB forming substance is completely arbitrary. The conditions can easily be selected so as to reach any conclusion desired. In our view, this does not meet the criteria for a scientific evaluation based on objective criteria. 

A decision that DecaBDE should meet the definition of PBT/vPvB based on the interpretation of such unclear criteria would set a precedent for future decision-making having negative implications for the entire chemical industry in Europe. 

The Annex XV dossier states further that degradation of DecaBDE might lead to “substances, which  . . .  act as precursors to substances with PBT/vPvB properties”. In our view this is stretching the already thin concept too far by now considering ‘precursors to precursors’. 

The actual weight of evidence presented is not sufficiently solid to support the dossier’s conclusions, which seem to be based essentially on a single study carried out in the laboratory and some anecdotal evidence that has not undergone peer-review. As discussed in detail in the Annex XV dossier, the overwhelming majority of studies conclude that DecaBDE will degrade in the environment to some extent, but that degradation does not lead to the formation of PBT or vPvB substances, since it seems to stop at OctaBDE congeners, occasionally at HeptaBDE congeners (the rate of degradation seems to decrease with decreasing degree of bromination).  Moreover, the precedent that would be set by defining DecaBDE as a PBT/vPvB based on degradation is put in further perspective when one considers that there is evidence to indicate that the analytical methodology for DecaBDE degradation itself may contribute to debromination findings. To summarize the discussion presented in the Annex XV dossier:

•Studies on degradation of DecaBDE in air report the formation of NonaBDE and small amounts of OctaBDE.
•Studies on degradation of DecaBDE in water and sediment, except the Canadian mesocosm study (see next point) report the formation of NonaBDE, OctaBDE and occasionally small amounts of HeptaBDE.
•The Canadian mesocosm study is only available as an abstract and is not fully reported yet. As mentioned on page 1 of the dossier, such data “should be treated with caution until the full details have been formally published in the peer-reviewed scientific literature” and it would be premature, in our view, to draw firm conclusions therefrom.
•Studies on degradation of DecaBDE in sewage sludge report degradation down to OctaBDE.
•Studies on degradation of DecaBDE in soil, except one study (Huang study, see next point) are either equivocal or largely find no evidence for degradation at all. 
•The key study in the Annex XV dossier is a study on soil by Huang et al (2010) which reports formation of lower BDE congeners at an appreciable extent. We would like to point out the fact that the study has been conducted in the laboratory under artificial conditions, while several field studies conducted in the real environment (e.g., by Kohler, Sellstroem, etc) found no degradation products of concern.
On balance, the weight of evidence does not support concluding that DecaBDE is a precursor to a PBT/vPvB substance. The case for DecaBDE being a precursor to PBT/vPvB substances is built on a small, limited laboratory study and data from a Canadian mesocosm study that is largely unpublished and has not undergone peer-review. Moreover, recent presentations by the study authors (Orihel et al., 2011) indicate that ‘it is not possible to conclude with confidence that lower brominated BDEs were formed . . .’.

A decision to conclude that DecaBDE is a PBT/vPvB substance on such a thin basis would set a dangerous precedent for future decision-making in Europe.	We agree that there is some ambiguity in the REACH Guidance and would welcome further discussion with Industry, EU Member States and ECHA on the topic of transformation. In this case we believe that the key studies show a significant level of formation of PBDEs of concern (more than ‘trace’ levels) over timescales of a few months in the environment. 

From our perspective, there is no ‘automatic’ listing of substances as SVHCs – this depends on the evidence that is available and whether or not a risk management options analysis indicates that identification as an SVHC is appropriate. Industry is also expected to take account of potential SVHC properties in their recommendations for risk management measures.

Each case needs to be considered based on a number of factors, so it is not appropriate to draw general conclusions from this dossier in our view.
In the case of decaBDE, our aim is to minimise the release of this substance to the environment. We hope that this action will also encourage the development of substances that do not degrade to more hazardous substances. 

The length of the dossier is testament to the fact that there is a large body of evidence that is mutually supportive of the conclusions we have drawn from the key studies (one for aquatic systems, one for soil):

•	The mesocosm experiment is, unfortunately, unlikely to be fully reported any time soon due to resource limitations in Canada. We have not drawn firm conclusions from this study. However, the analytical work has been carried out by an experienced government laboratory, so we have confidence in the findings reported to date. We also consulted the researchers and they agreed with the text that we drafted, based on the public information that was available. Whilst peer review of academic studies is an accepted part of the normal scientific process, it is not always necessary if the studies have been well conducted (e.g. laboratory studies performed for registration purposes). We therefore consider this study to be much more than anecdotal. The authors of the study are naturally cautious about drawing conclusions from their results, given the analytical methods available to them and the lack of detailed reporting to date. However, the comment that they indicate that “it is not possible to conclude” on the findings only relates to one portion of the overall study – an analysis of sediment using 13C measurement - and so cannot be extrapolated to the whole experiment. Other parts of this study show the accumulation of penta- and other PBDEs in fish, for example.

•	We have summarised a large number of studies that demonstrate the potential for transformation through both microbial and metabolic processes. The Huang et al soil study is supported by additional studies investigating the role of roots, for example.

We recognise that laboratory studies are not always environmentally realistic. However, unless we resort to requesting mesocosm studies, we have to be able to use them. In this case, we believe the Canadian mesocosm study is environmentally realistic, and the Chinese greenhouse study is reasonably so.

HeptaBDEs are vPvB substances, and we note that Industry accepts that they can be formed via decaBDE degradation. Whether the degradation can be said to “stop” at octaBDEs depends on the timescales of the tests – it is possible that transformation could be more extensive over longer periods. We agree that the PBDEs are formed in small amounts – studies suggest that other substances may also be formed, but they are not usually investigated. We present additional information in the dossier to demonstrate that some of these other substances (e.g. hydroxylated PBDEs) might be hazardous.

We accept that some studies have not detected transformation, and have reported them in the dossier for transparency. However, they are not directly comparable with either of the key studies because they do not address what happens immediately after addition of decaBDE to the media. For example, the Sellstroem et al. study looked at a substantially aged soil – we do not know what happened to the PBDE content between the time the sludge was originally applied and the time the soil was eventually sampled twenty years later.	
18	2012/10/18	Company
Albemarle Europe SPRL
Belgium	p. V Proposal and conclusions
The August 2012 Annex XV dossier Identification of a Substance of Very High Concern (SVHC) for decabromodiphenyl ether (DecaBDE) proposes on page 1 that DecaBDE is a “substance that transforms under environmentally relevant conditions to lower molecular weight polybrominated diphenyl ether (PBDE) congeners that are considered to be PBT/vPvB substances”, e.g. hexa- and heptaBDEs.

For the following reasons Albemarle does not agree with this conclusion as a wide range of evidence not supporting this conclusion has not been considered in the Annex XV dossier. Some of this evidence is summarized below.
DecaBDE has been investigated extensively for its toxicological and ecotoxicological properties in the last decades. DecaBDE’s toxicology data do not suggest a concern for transformation products.
DecaBDE has an extensive toxicology database demonstrating NOEL/NOAELs of 1000 mg/kg/d, and has been subjected to multiple repeated dose studies that include lifetime exposures (Hardy et al. 2009).  As correctly noted in the dossier, three previous evaluations of DecaBDE under EU’s Existing Substances Regulation were completed in 2002, 2004, and 2007.  These evaluations concluded DecaBDE did not require classification or labelling for health or environmental effects.  In 2009, the European Food Safety Authority (EFSA) rendered an opinion on PBDEs in food concluding current EU dietary exposure to BDE 209 and the sole hexa- or heptaBDE considered, BDE 153, did not raise a health concern (EFSA 2009).  A margin of exposure (MOE) of 97,000 was calculated for BDE 209, even when based on studies in neonatal mice using an unacceptable experimental design. (Goodman 2009; Williams and DeSesso 2010; Holson et al. 2008).  Using the recent guideline- and good laboratory practices-compliant developmental neurotoxicity study with a NOAEL of 1000 mg/kg/d (Biesemeier et al. 2011), the MOE is even higher.  A human oral reference dose of 4 mg/kg/d, derived in Hardy et al. 2009, has been confirmed by the International Toxicity Estimates for Risk Assessment after independent review (ITER 2011). It is important to underline that these NOEL/NOAELs, MOE, and oral reference dose are not indicative of metabolism to toxic/bioaccumulative substances.

Environmental monitoring also does not indicate DecaBDE’s transformation to hexa- and heptaBDEs. DecaBDE has been in commercial production and use for roughly 40 years, and evidence of its transformation should be apparent.  To the contrary, environmental monitoring conducted in various countries shows decreasing levels of lower PBDEs simultaneous with DecaBDE’s use.
•	As early as 2003, evidence of a slowing of the increase in PBDE levels was apparent in guillemot eggs (Sweden, monitoring over 1969-2000), beluga whales (Arctic, 1982-1987 and 1989-2001, St. Lawrence Estuary, 1988-1999), and seals (Arctic, 1981-2000) (Law et al. 2003).  By 2006, it was apparent that the increase in Great Lakes herring gull eggs had stopped.(Gauthier et al. 2008).  
•	A temporal trend in mussels collected in the Seine estuary, showed an increase in PBDE concentrations over 1982 – 1993, which leveled off in 1999 and 2001, and then began to decline after 2002 (Law et al. 2006). 
•	Sewage sludge in Sweden showed a downward trend of ~20%/year for the heptaBDE 154 and the octaBDE 183, while BDE 209 increased by 16% (Olofsson et al. 2012). 
•	BDE 47, 49, 100, 153 and 154 were the most abundant PBDEs in gannet eggs in 2 UK colonies over 1977 to 2007.  Individual congeners and total PBDE content increased mainly from the late 1980s, peaked in 1994, and then rapidly declined so that by 2002 concentrations were similar to or lower than those in the 1970s and 1980s (Crosse et al. 2012).    
•	Total tri- to hepta-BDE concentrations fell significantly between 2002 and 2005 in sockeye salmon collected in the northwest Pacific (Ikonomou et al. 2011). A steady but statistically nonsignificant decline in PBDE concentrations between 2002 and 2008 was seen in sablefish.  Relative proportions of the main BDE congeners did not change over time within species or location.
•	In Swedish peregrine falcon eggs, concentrations of BDE 99, 100, 153, 183 and 209 increased from 1974 to 2000.  After the early 2000s, BDE 99, 100, 153 and 183 concentrations decreased while 209 increased (Johansson et al. 2011).
•	Concentrations of penta- and hexaBDE congeners (BDE 100, 99, 153) in trout from the Great Lakes Ontario and Michigan and smelt from Lake Ontario started to decrease in the mid-1990s (Batterman et al. 2007).    
•	The 1980 – 2009 time trend of BDE 47, 99, 100, 153 and 154 in a top predator fish in the Great Lakes, trout, shows declining levels.  Levels in walleye, the other top predator fish, began leveling off in the late 1990s (Crimmens et al. 2012).

Thus, neither DecaBDE’s toxicology data nor environmental monitoring indicate concerns for transformation to hexa- or heptaBDEs.  

DecaBDE’s potential listing as a SVHC is based on its possible transformation in sediment and soil.  Specifically, the Annex XV dossier, page v, indicates PBT/vPvB transformation substances, e.g. hexa- and heptaBDEs, are produced in individual amounts >0.1% within a year or act as precursors to substances with PBT/vPvB properties. 

The REACH definition of PBT/vPvB substances (European Commission, 2011 .) does not include precursors or transformation products, their amounts, or the time scale for their production.  Thus, DecaBDE’s potential listing as a SVHC based on these points is breaking new ground, and the issues and implications must be carefully considered.  Inclusion of “precursors to substances with PBT/vPvB properties” is especially concerning given the wide range of possible interpretations.  

The REACH Guidance, PBT Assessment (ECHA,  2008a), p 10, addresses levels of PBT/vPvB transformation products.  Substances can be considered PBT/vPvB if individual PBT/vP/vB degradants are produced at levels ≥0.1% of the parent molecule.  The threshold value for total PBT/vPvB degradants can be up to 10%, whereas the 0.1% value is suggested to apply where “uses leading to significant emissions are anticipated”.  Thus, REACH Guidance provides leeway in amounts of degradants produced, and the amount is not fixed at 0.1% as implied in the dossier.  The hexa- and heptaBDE’s reportedly produced from DecaBDE transformation are substantially below the 10% value, and DecaBDE emissions from its industrial use are well controlled.

The REACH Guidance does not specify a timeframe of PBT/vPvB degradant production other than to indicate the total amount of such products should not exceed 1 tonne/year, p 162, whereas the dossier applies the one-year timeframe to the 0.1% level.  DecaBDE emissions from its industrial use in the EU indicate << 1 tonne of degradants/year could be formed.
•	The Annex XV dossier, p 162, states DecaBDE’s total 2007 emissions from its industrial use in the EU were 0.35 tonnes/year, e.g. roughly one-third of the 1 tonne/year limit for PB/vPVB substances. Amounts of DecaBDE degradants would be lower.
•	More recent emission estimates are available from industry’s VECAP program that covers 90% of European Flame Retardant Association members (VECAP 2011).  In 2011, DecaBDE EU emissions were 60 g/tonne or 0.006% per tonne consumed and illustrate effective emission control.  At a 2011 volume of 7500 to 10000 tonnes, 0.45 to 0.6 tonnes of DecaBDE would be emitted during its industrial use.  Thus, degradants would be <<1 tonne/year.  

In contrast, the dossier, p 162, estimates’ the total  emissions of DecaBDE in the EU as 37.9 tonnes!  Of this, 99.5% were losses during textile service life/disposal.  However, the Annex XV dossier (p 162-163) considers this estimate uncertain and “probably not reliable”.  The concern for generation of degradants in amounts > 1 tonne/year rests with the uncertain and unreliable estimate of emissions occurring during textile service life/disposal.  A prudent course would include a reliable estimate of these emissions prior to making a determination of DecaBDE’s SVHC status.

Consideration should be given to increasing the threshold value above 0.1% given the effective emission control during DecaBDE’s industrial use and the uncertain data on which the Annex XV dossier is based.  Page 10, PBT Assessment, REACH Guidance states “it may be considered, for the sake of relevance of risk posed by such an amount and the proportionality of assessment effort to elevate the threshold value above 0.1%” while noting that an elevated threshold should not exceed 10% (w/w) and total PB/vPBT degradants should not exceed 1 tonne/year.  Assuming total emissions of 37.9 tonnes/year, elevating the threshold from 0.1 to as little as 1 or 2% would meet the less than 1 tonne/year degradant total.  That is, 1% of 37.9 is 0.379 tonnes.

We have specific concerns on the analytical methodology used in the studies that are reported as evidence for environmental degradation of DecaBDE. It seems that the analytical methodology of the studies claiming to have found degradation products has not been evaluated with sufficient scrutiny. The studies listed at the end of this paragraph typically used gas chromatography/mass spectrometry (GC/MS) and have not excluded injection port or on-column debromination of DecaBDE during the GC-analysis. GC/MS analyses require very high temperatures to vaporize DecaBDE in the injection port (melting point ~305°C) and to elute DecaBDE through the GC column (up to 350°C). Unvaporized DecaBDE will adhere to the injection port, causing sample carry-over and serving as a source of degradants. The high elution temperature required and DecaBDE’s long on-column retention due to its high adsorptive properties can also result in degradation – thermogravimetric analysis demonstrates DecaBDE undergoes approximately 1% weight loss at 290°C.  DecaBDE’s potential for injection port or on-  column degradation has not been taken into account in the published literature with respect to debromination, and has caused misinterpretation of the study results.

Reports indicating DecaBDE’s transformation to lower brominated congeners: . Gerecke et al. (2006), Tokarz et al. (2008); . La Guardia et al. 2007, He et al. 2006. Kierkegaard et al. 1999, Stapleton et al. 2004, .Tomy et al. 2004.
These studies frequently had poor recoveries of the BDE 209 congener,
 (see Huwe et al. 2008) 

DecaBDE’s adsorption on the injection port and column can be handled with 1, preferably 2, toluene purges between samples, frequently cleaning of the injection port, and avoidance of glass wool. Unless these steps are taken, DecaBDE can be expected to degrade with a resultant faulty interpretation due to detection of lower brominated diphenyl ethers.  None of the studies reporting DecaBDE’s biotransformation to lower brominated diphenyl ethers reported these procedures in their analytical methodology.	

The comments draw attention to mammalian studies. Lack of effects in mammals does not provide any information on whether degradation occurs in the environment. As pointed out in the dossier, the percentage formation of the lower molecular weight PBDE congeners is very low in mammals. We are not making the case that toxicity will be observed directly following exposure to decaBDE. Rather, it is our contention that decaBDE can act as a long-term source of PBT/vPvB substances in soils and sediments, along with a small contribution from in vivo metabolism, that is the primary issue. The dossier also highlights effects observed in more recent studies that have not been summarised by the registrants (e.g. in fish and amphibians). We would also point out that most (eco)toxicological studies are of relatively short duration, and do not provide any information on the actual presence of transformation products, so their contribution (if any) is unknown.

The EFSA evaluation concerns human health effects. It did not consider PBT/vPvB properties, for example. 

We have added this additional monitoring trend data for completeness. As pointed out in the dossier, the available monitoring data are confounded by the ongoing releases of PBDEs from the now banned commercial penta- and octaBDE products. Whilst we agree that there has been a general decline in levels, there are no signs that these levels are declining to zero and indeed, we know that lower molecular weight PBDEs continue to be present in UK WWTP influents. Ongoing emissions are likely to mask small levels of transformation.

The main argument concerns formation of hexa- and heptaBDEs. We are simply pointing out that formation of octa- and nonaBDEs, which seems to be accepted by Industry, does not mean that the transformation has stopped, since this depends on the timescale of the tests.

As pointed out in the dossier, the 10% limit is intended to help registrants decide how much effort to put into a CSR.  We argue that emissions are significant, as demonstrated by the voluntary monitoring programme (Section 3.3), so the 0.1% level is more appropriate in our view.

We agree that the guidance does not specify a timescale, although given the nature of the hazard, we believe it is appropriate to consider periods of months or more.

The cited release figures do not take account of a) releases from sites not included under the VECAP and b) releases from products during their service life and disposal. As we point out above, the voluntary monitoring programme shows that decaBDE is being released over a very wide area.

We agree that the emission estimates from this part of the life cycle, as well as others, are uncertain. We believe that industry is best placed to provide more accurate estimates. 

We agree that analytical artefacts could be a problem, and have added a discussion to the dossier.  Journal space often does not allow full analytical details to be provided, and it is beyond the resources of the UK CA to contact every laboratory that has published results on decaBDE to establish what quality control measures have been used. However, the two key studies do appear to have taken relevant steps to control analytical artefacts.
	
			See also:
Comment 18 attachment (VECAP 2011 report EU + references quoted.zip).zip		
16	2012/10/17	Member State
Sweden	Although the Canadian studies by the groups of Derek Muir and Gregg Tomy are not yet fully published, we find the studies reliable and that there are sufficient evidence for defining decaBDE as a PBT/vPvB substance based on the results available so far from the Canadian aquatic studies. Further support for degradation of decaBDE to PBT-substances comes from studies in soil by Huang et al (2010) and Wang et al (2011). Also studies in birds (Van den Steen, 2007), cows (Kierkegaard et al 2007), and rodents (e.g. Huwe and Smith, 2007) support formation of lower brominated congeners in vivo. Additionally, decaBDE is rather common in outdoor air, and the decaBDE adhered to small particles are thus available to photolysis. The evidence from the group of Stapleton for photolytic transformation of decaBDE to, at least, nonaBDE is quite compelling, but some further transformation into lower brominated analogues also occurs.
Overall, we support that decaBDE could be nominated as a SVHC based on its degradation to PBT-substances (and POPs).	Thank you for your support.	
15	2012/10/17	National NGO
Naturskyddsföreningen, Swedish Society for Nature Conservation (SSNC)
Sweden	The Swedish Society for Nature Conservation (SSNC) supports the proposal to categorise Bis(pentabromophenyl) ether (DecaBDE) as a Substance of Very High Concern.
 
The SSNC is the largest and most influential environmental organisation in Sweden, currently with 192,000 members nationwide. The SSNC works to protect the natural environment and human health, and to strengthen global solidarity.	Thank you for your support.	
14	2012/10/17	National NGO
CHEM Trust
United Kingdom	CHEM Trust supports the inclusion of deca-BDE in the REACH candidate list according to article 57 d) and e).	Thank you for your support.	
13	2012/10/16	National NGO
The Cancer Prevention & Education Society
United Kingdom	We support the nomination of this chemical to the Candidate List as a substance of very high concern	Thank you for your support.	
12	2012/10/16	National NGO
IEW
Belgium	We support the nomination of this chemical to the Candidate List as a substance of very high concern	Thank you for your support.	
11	2012/10/16	Member State
Belgium	Based on the information on the degradation/transformation products it can be concluded that the substance is to be identified as PBT and vPvB.	Thank you for your support.	
7	2012/10/12	Member State
Germany	The German CA supports the proposal to identify DecaBDE as SVHC according to Article 57 d and e.	Thank you for your support.	
6	2012/09/26	National NGO
Danish Consumer Council
Denmark	The Danish Consumer Council (DCC) supports the inclusion of the substance in the candidate list. The DCC wants dangerous chemicals in consumer products to be banned or at least minimized to the lowest possible levels. The inclusion of this substance to the candidate list is a strong signal to producers that the use of this substance should in time be stopped, and substituted with a less dangerous one.	Thank you for your support.	
4	2012/09/20	Other contributor
FRETWORK The flame retardant textiles network ltd
United Kingdom	Under the name of the Textile Finishers Association (TFA) much data on the use of DecaBDE in textile applications in the UK was generated, discussed with the UK EA and DEFRA and our data was subsequently included in the RAR by the report writer. This data does not appear to have been taken into and used in the ann XV dossier. We are concerned for the futre of this and any other substance stewardship actions we make colelctively take as an industry group relating to the use of DecaBDE and any similar substances.	The dossier is mainly intended to identify relevant hazards. Product stewardship is an important feature of the REACH Regulation. A brief description of the voluntary initiative was provided in Part II of the dossier. It may be taken further into account during the prioritisation step if decaBDE is added to the Candidate List. 	
 3	2012/09/19	International NGO
ChemSec
Sweden	Very comprehensive dossier that could and should be used to identify structurally similar BFRs such as Deca-BDEthane which is one of the main substitutes of Deca-BDE. We fully support the identification of Deca-BDE as a SVHC.	“Deca-BDEthane” is being evaluated by the UK under the first Community Rolling Action Plan. A decision on the need for further risk management can be taken once that process has been completed.	
2	2012/09/19	International NGO
ClientEarth
Belgium	As all PBT substances, DecaBDE should be phased out from the market as soon as possible. ClientEarth strongly supports the listing in the candidate list of this substance due to its hazards being known for a long time. However it would be much better to have Annex XV dossiers to be much shorter as 264 pages is much longer than the average Annex XV dossiers submitted so far, especially considering the fact that the substance's hazards are well known. Finally we would have welcomed the proposal, at the same time of alternative brominated flame retardants in order to avoid the use of equally hazardous substances.	The dossier is long because we believe it is important to present all relevant data to allow a weight of evidence argument to be made. 

1	2012/09/17	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of DecaBDE as a SVHC.	Thank you for your support.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
24	2012/10/18	Member State
Norway	p 97 summary and discussion on degradation; 
We would like to draw the attention to some additional studies further supporting degradation. 
Meyer et al. (2012) used snow cores from the Devon Ice Cap in Nunavut, Canada to determine the recent depositional trends of BFRs. Snow pits were dug in 2005, 2006, and 2008. Dating using annual snow accumulation data, ion chemistry, and density measurements established that the pits covered the period from approximately 1993 to spring 2008. Samples were extracted under clean room conditions, and analyzed using GC-negative ion MS for 26 tri- to decabromodiphenyl ethers (BDEs). Decabromodiphenyl ether (BDE-209) was the major congener present in all samples followed by nona-BDEs (BDE-207, BDE-206, and BDE-208), both accounting for 89% and 7% of total BDE, respectively. Pearsons correlations between the concentrations of different homologue groups were calculated to investigate the possibility of debromination prior to or after deposition. BDE-209 concentrations were in most cases significantly correlated (P < 0.05) to tri- to nona-BDE homologues. The strength of the correlations increased with increasing degree of bromination, and according to the authors this indicated a stepwise debromination of BDE-209 to lower brominated BDEs. Furthermore, Meyers et al. found that debromination was corroborated by the relative high concentrations of nona-BDE in the samples. They also believed that the notably large concentration of congeners BDE-201 and BDE-202 in the samples was an indication of BDE-209 debromination. BDE-202 is believed to be a marker of BDE-209 debromination. The ratio BDE 197/BDE 201 was found to be near the ratio found after photolytic debromination of BDE-209.
On the basis of the predominance of BDE-209 in all samples Meyers et al. found that photolytic debromination of only a small fraction of BDE-209 in the atmosphere could have occurred and that it could have contributed to the relatively large fractions of the measured amounts of lower brominated BDEs in the sample. Whereas the higher brominated BDEs was found to may have been generated by photolytic debromination in the snow. 
The possibility of photolytic debromination of BDE-209 in the atmosphere was also indicated in the study by Tian et al (2011). High ratios of BDE-202 (taken as a marker for degradation of BDE-209) and BDE-85 (also believed to be a degradation product), were detected in atmospheric depositions in southern China where e-waste processing is carried out (Tian et al. 2011).
Barton et al. (2012) investigated BDE congener patterns in different trophic levels of lake food webs and found an  increase in less brominated congeners and decline in BDE-209 that suggest that debromination capability is common among many food web components. The presence of some congeners historically absent from industrial mixtures supports this interpretation (i.e., BDE-35, BDE-77 and BDE-156). Very low levels of BDE-209 in primary consumers indicate that PBDE biotransformation is enhanced at this trophic level
In a study by Munoz-Arnanz et al. (2011) the PBDE content and congener profiles in failed eggs from two colonies of white stork (Ciconia ciconia) in Spain were studied. The average total PBDE concentration was 1.64ng/g (wet weight, w.w.) for the rural colony and 9.08ng/g (w.w.) for the urban colony. Higher brominated BDEs dominated the congener profiles of both colonies. Of particular interest was the determination of BDE-209 as the dominant congener accounting for 44.1% and 38.6% of the total PBDE content in the rural and urban colonies, respectively. BDE-202, considered an indicator of BDE 209 debromination, was detected in 83% and all of the samples from rural and urban colonies, respectively. The observed congener profile in which BDE-207>BDE-208>BDE-206 does not correspond to any known technical PBDE mixture and was believed by the authors to be evidence for possible BDE-209 degradation.
In a recent study, La Guardia et al. 2012 observed a PBDE profile in both sediment and mollusks collected down-stream from a textile manufacturing outfall that were consistent with exposure to commercial decaBDE. The PBDE levels decreased with increasing distance downstream from the outfall. The relative abundance of PBDE congeners in sediments and mollusks in this study was BDE-209 ≫ −206 > −99, −207,−47 > −208 and −100. The major constituent congener of commercial decaBDE, BDE-209, contributed 90 to 96% of the sediment total PBDE concentration. The BDE-209 levels detected in the filter-feeding bivalve (Corbicula fluminea) and the grazing gastropod (Elimia proxima) ranged from 43700-2388 and 22700-2200 ng g 1 lipid, respectively. Like in sediment, decaBDE was by far the most dominant PBDE congener detected. Likely debromination products were also observed in the mollusks. The study provides new information on the bioaccumulation potential and debromination of decaBDE.
DecaBDE is present at relatively high levels in sediments and macroinvertebrates of the River Po and a study was performed to assess the bioavailability and biotransformation of decaBDE in fish in this area (Viganò et al. 2011). Contrary to sediments and invertebrates of the same area, no fish sample contained detectable levels of BDE-209. All fishes contained typical PBDE representatives, e.g. BDE-47, BDE-99, BDE-100, BDE-153 and BDE-154, but more importantly they contained three congeners, i.e. BDE-179, BDE-188 and BDE-202, which are not present in any technical formulations and are known products of BDE-209 debromination in fish. The study shows that BDE-209 enters the food web of the River Po contributing to the load of lower brominated PBDEs. 
Also. some analyses of sewage sludge from Norwegian WWTPs indicate debromination of decaBDE (Hanslin and Eggen, 2006). In the samples the percent nonaBDE related to decaBDE was in the range of 20-31 %, whereas the proportion of sum octaBDE was low compared to nona- and decaBDE. This congener pattern therefore does not seem to agree with the commercial products and may indicate debromination.  Sludge from one WWTP contained levels of decaBDE in the range1200-1400 μg/kg dry weight (dw),  nonaBDE in the range 295-351 μg/kg dw, the sum octaBDE was about 16 μg/kg dw, and a low proportion of lower-brominated BDEs. The sludge from another WWTP had concentrations of decaBDE of 153 μg/kg dw, nonaBDE of 47.8 μg/kg dw and the sum octaBDE was 3.3 μg/kg dw, and higher levels of sum tetraBDE (288 μg/kg dw) and sum-pentaBDE (325 μg/kg dw).
 
References:

Bartrons M, Grimalt JO, de Mendoza G, Catalan J (2012) Pollutant Dehalogenation Capability May Depend on the Trophic Evolutionary History of the Organism: PBDEs in Freshwater Food Webs. PLoS ONE 7(7): e41829. doi:10.1371/journal.pone.0041829

Hanslin. H. Eggen. T. 2006. Opptak av bromerte flammehemmere i planter. Bioforsk rapport  Vol. 1 Nr. 83. http://www.bioforsk.no/ikbViewer/Content/28680/r_1_83B_hanslin.pdf
English summary: http://www.bioforsk.no/ikbViewer/Content/99574/English%20Summary.pdf

La Guardia MJ, Hale RC, Harvey E, Mainor TM, Ciparis S. In situ accumulation of HBCD, PBDEs, and several alternative flame-retardants in the bivalve
(Corbicula fluminea) and gastropod (Elimia proxima). Environ Sci Technol. 2012, 5;46(11):5798-805. 

Meyer T, Muir DCG, Teixeira C, Wang X, Young T, Wania F. Deposition of Brominated Flame Retardants to the Devon Ice Cap,Nunavut, Canada. Environ. Sci. Technol. 2012, 46, 826−833.

Muñoz-Arnanz, J., Sáez, M., Aguirre, J.I., Hiraldo, F., Baos, R., Pacepavicius, G., Alaee, M. and Jiménez, B. (2011). predominance of BDE-209 and other higher brominated diphenyl ethers in the eggs of white stork (Ciconia ciconiai) colonies from Spain, Environment International 37, 572-576.

Tian, M., Chen, S-J., Wang, J., Shi, T., Luo, X-J. and Mai, B-X. (2011), Atmospheric deposition of halogenated flame retardants at urban, e-waste, and rural locations in southern China, Environmental Science & Technology45, 4696–4701. (not referred to in the SVHC report)

Viganò, Luigi, Roscioli, Claudio, Guzzella, Licia (2011). Decabromodiphenyl ether (BDE-209) enters the food web of the River Po and is metabolically debrominated in resident cyprinid fishes.  Science of the total environment, Volume 409, Issue 23, November 2011; Pages 4966-4972
	Thank you for pointing out this information. 

The Meyer et al. reference was already included in Section 3.2.3.2 as evidence of long range transport potential. However, we have now mentioned it in Section 3.1.1.2.1.

The interpretation of the Tian et al (2011) study might be complicated by the multiple sources of decaBDE (and other PBDE products) of differing purities likely to present in the environment of South China. For this reason, we have decided not to include it.

The other studies refer to PBDE levels in biota (and sediment). Differing congener patterns in biota samples compared to commercial products might indicate transformation, but could also be due to less pure products or differential release or uptake rates. We have added a summary of the Viganò et al. (2011) study, but do not think the other studies provide significant additional information to that already in the dossier, so we have not included them. (N.B. The La Guardia et al. (2012) study was already included in Appendix 1.)	
21	2012/10/18	European institution
European Chemicals Agency
Finland	•	Substance name (section 1.1) : we suggest including in section 1.1 the following CAS registry numbers in the report :
	109945-70-2 
	145538-74-5 
	1201677-32-8

•	Name and other identifiers of transformation products (section 1.3): please consider changing the CAS index names of the transformation products in Table 4 as follows:
	40088-47-9: Benzene, 1,1'-oxybis-, tetrabromo deriv.
	32534-81-9: Benzene, 1,1'-oxybis-, pentabromo deriv.
	36483-60-0: Benzene, 1,1'-oxybis-, hexabromo deriv.
	68928-80-3: Benzene, 1,1'-oxybis-, heptabromo deriv.
	32536-52-0: Benzene, 1,1'-oxybis-, octabromo deriv.
	63936-56-1: Benzene, 1,2,3,4,5-pentabromo-6-(tetrabromophenoxy)-

•	Harmonised classification and labelling (section 2): please consider updating the following statement: “no proposals [for classification] have been submitted to the CLP Inventory”. Indeed, 9 aggregated notifications have been submitted to the C&L Inventory (number of notifiers associated: 88; last update: 31/05/2012). This information is publicly available via the ECHA website at: http://echa.europa.eu/web/guest/information-on-chemicals/cl-inventory-database

•	Assessment of PBT/vPvB properties (section 6.1.1): on page 139 please re-consider the following statement: “neither octa- or nonaBDEs are considered to be PBT or vPvB substances on the basis of the available data”. Indeed, this definitive statement seems not to be in accordance with the conclusions drawn in Appendix 1 where only some doubts are expressed with regard to the B and T conclusions.
Furthermore, it might be worth noting that in the context of the Water Framework Directive, the European Commission has proposed to include octaBDE to the list of Priority Substances as a “Priority Hazardous Substance” because of its PBT properties (cf. SEC(2011) 1547 final prepared by the European Commission). 	Thank you for this information which has been added to the supporting document. 

We have added the classification information for completeness. However, we do not know the basis for the entries listed on the CLP Inventory. They could be based on different interpretations of the same data, or different data sets, but they could also be made in error. We have not attempted to investigate this further.

We meant that they were not clearly PBT/vPvB, and have modified this statement accordingly.

We have mentioned the proposed WFD listing of octaBDEs in a footnote to Appendix 1. We understand that the octaBDE congeners themselves have not been identified as PBT, but rather the listing is based on the tetra- to heptaBDE content of the commercial product.	
20	2012/10/18	Industry or trade association
European Flame Retardants Association
Belgium	Non-exhaustive detailed comments on Part 1 ‘Justification’

3.1.1.2.1 Phototransformation in air

Page 27: Ahn et al (2006): The study has deficiencies in their analytical method. It attempted identifying degradation products by GC only without further confirmation via mass spectrometry.  Given the very high likelihood of coelutions – as is shown in figure 3 of the publication – the observed peaks cannot be unequivocally assigned to specific BDE congeners. The study results should therefore be considered equivocal.

3.1.1.2.3 Phototransformation in soil

On balance, the field study by Sellstroem et al (2005), which did not find indications for degradation under realistic conditions, should be given more weight than laboratory studies. Ageing and shading processes may prevent phototransformation in soil in the real environment.

3.1.2.2 Biodegradation in sediments

Page 42: Lee and He (2010): the study was conducted on OctaBDE. While the results are interesting, they should not be extrapolated to DecaBDE.

Page 62, Discussion: 
-	3rd para: The discussion omits that Kohler et al (2008) found “no evidence for sediment mediated long term transformation of PBDE within the observed time span of almost 30 years.”

3.1.2.4 Biodegradation in soil

Page 79: He et al. (2006): it should be noted that the study used trichloroethylene (TCE) as primer for the microbes used.  No degradation was found in experiments without TCE (using nonane as solvent). In our view this process is not environmentally relevant.

Page 80: Robrock et al. (2008): Similar to He et al (2006) the study used halogenated solvents as electron donors (perchloroethanol and pentachlorophenol) as primer for the microbes used.  In our view this process is not environmentally relevant.

Page 84: 
Huang et al. (2010) is the key study here. However, it is the only reliable study that reports degradation of DecaBDE in a soil/ plants environment to lower BDEs. As pointed out in the discussion, other studies – e.g. Vrkoslavava et al. (2010) either do not confirm this, provide equivocal evidence or were not conducted with DecaBDE (Lee and He (2010)).

3.1.2.5 Summary and discussion on biodegradation

The studies quoted as supporting evidence for degradation by sediment- and soil-dwelling microorganisms have limited relevance as discussed above. They may have found some degradation under the conditions studied, but these conditions are not relevant for the real environment; moreover the studies have several shortcomings or were considered as ‘equivocal evidence’ in the detailed discussions of the Annex XV dossier. We therefore submit that currently no conclusion can be drawn on this endpoint.

3.3. Environmental monitoring data, 3.4. Current use of controls to minimise emissions to the environment (p. 165-165).

Overall, 2011 results for the VECAP programme have shown that while sales volumes had increased, total potential emissions of DecaBDE at participating sites were reported to be less than 0.5 metric tonnes per year. This represents a reduction in emissions of over 66% compared to 2010 and a reduction of 87% compared to 2008. 

References quoted in the comments:

Ahn et a.l, 2006, Photodegradation of decabromodiphenyl ether absorbed into clay minerals, metal oxides and sediment. Environm. Sci. Technol. 40, 215-220
He et al. 2006.  Microbial reductive debromination of polybrominated diphenyl ethers (PBDEs).  Environ Sci Tech 40:4429-34., 

Huang et al. 2010.  Behavior of decabromodiphenyl ether (BDE-209) in the soil-plant system: uptake, translocation, and metabolism in plants and dissipation in soil.  Environ Sci Technol 44:663-667.

Kohler et al., 2008, Temporal trends, congener patterns and sources of octa-, nona-, and decabromodiphenyl ethers (PBDE) and hexabromocyclododecanes (HBCD) in Swiss Lake Sediments. Environm. Sci. Technol. 42 (17), 6378-6384

Lee and He, 2010, Reductive debromination of polybrominated diphenyl ethers by anaerobic bacteria from soils and sediments. Applied and Environmental Microbiology, 76 (3), 794-802 

Orihel et la. 2011.  Debromination of 13C-labelled decabromodiphenyl ether in lake sediments.  ATW poster.
Robrock et al., 2008, Pathways for the anaerobic microbial debromination of polybrominated diphenyl ethers, Environm. Sci. Technol. 42 (8), 2845-2852 

Sellstrom et al. 2005.  Effect of sewage-sludge application on concentrations of higher-brominated diphenyl ethers in soils and earthworms.  Environ Sci Technol 39(23): 9064-70.

Vrkoslavova et al., 2012, Absorption and translocation of polybrominated diphenyl ethers (PBDEs) by plants from contaminated sewage sludge. Chemosphere, 81, 381–386.	

We have added a note to this effect.

As we mention in our response above, the Sellstroem et al study involved soil collected up to two decades after the last known application of contaminated sewage sludge. We do not know what level of degradation occurred during the intervening period. The study shows that after a long period of ageing the substance no longer appeared susceptible to phototransformation (or microbial degradation). We recognise this in the conclusions of this section.

We believe the octaBDE findings are relevant, because decaBDE has been shown to degrade to octaBDEs in several studies. The Lee and He (2010) study demonstrates that the degradation does not necessarily stop with this congener, i.e. microbes appear to be capable of performing further reactions. We already point out that some studies do not appear to show any degradation, but have highlighted the findings of the Kohler et al. study as suggested.

These studies show that some specific microbial species can debrominate PBDEs, and the summaries recognise that this requires co-metabolism. We note that one culture in the Robrock et al. study did not require halogenated solvent to perform the reaction, and further studies by this group also found evidence of debromination in the absence of electron donors.

We note that Industry considers the Huang et al study to be reliable. For the reasons mentioned in the dossier, the results of Vrkoslavava et al. (2010) are not directly comparable. We think it is acceptable to mention studies that can help provide an explanation for the observations even if they are not themselves fully adequate, provided they are not given undue weight.

Thank you for providing the VECAP information. The apparent level of emission reduction is a significant achievement. It does not, however, address emissions from treated articles or sites not involved in the scheme.	
18	2012/10/18	Company
Albemarle Europe SPRL
Belgium	3.1.2.2 Biodegradation in sediments, 3.1.2.4. Biodegradation in soil  p.33 to 63 and 81 to 97 with respective summaries and discussion.

The Annex XV dossier does not weigh the reported studies on their reliability and scientific validity, for example a guideline/GLP compliant anaerobic sediment biodegradation study of 14C-BDE209 did not detect degradation (Schaeffer and Flagg 2001).  A guideline/GLP compliant biodegradation study in soil has not been conducted (or required) because of DecaBDE’s persistence.

Instead  two “key sets of information” were utilized to justify a finding of SVHC.  Part I, page 1 indicates the sediment studies of Orihel et al. (2009) and Muir (2011) and the soil study of Huang et al. (2011). However, in a weight of evidence approach the following facts should be considered:
•	The key sediment and soil studies were not performed according to accepted international guidelines for the determination of biodegradation in those matrixes.
•	The key sediment and soil studies were not performed according to good laboratory practices (GLPs).
•	Noncompliance with established guidelines and GLPs lessens the utility of this key information for regulatory purposes.
o	Guideline/GLP-compliant studies are considered “reliable without restriction” or “reliable with restrictions” under the standard scoring method of data reliability for EU regulatory purposes  (Klimisch et al. 1997; ECHA 2008).

o	The Orihel et al. (2010) and Muir (2011) sediment work are not available as final reports or full publications.  Only abstracts are available for review, and therefore this work is either “not reliable” (the documentation is not sufficient for an assessment) or “not assignable” (studies or data from the literature which do not give sufficient experimental details and which are only listed in short abstracts).  Studies with these ratings can be supporting studies or part of a weight of the evidence approach, but should not be used as a key study. 
•	Both key data sets used gas chromatography as the analytical method.   DecaBDE is prone to degrading to lower brominated PBDEs (LBDEs) in the injection port and/or on-column (Lagalante et al. 2011). Unvaporized DecaBDE will adhere to the injection port, causing sample carry-over and serving as a source of degradants.  On thermogravimetric analysis, DecaBDE undergoes approximately 1% weight loss at 290°C, which may occur on-column. This was not taken into account in interpreting or reporting the results.

•	The Huang et al. (2010) study has deficiencies.
o	The source, composition, and purity of the test article were not reported, and are critical to interpreting the results, because the test article may have introduced trace quantities of presumed degradants, e.g., LBDEs.  
o	The identification of LBDEs, e.g. chromatographic retention time, was nonspecific.
o	Laboratory contamination is an issue with PBDEs.  The reported LBDEs were not definitively identified as being derived from the test article. A labeled test article, e.g. [14C]- or [13C]-BDE209, and analysis in a ‘clean’ laboratory would be required to distinguish between the two.
o	Neither validation of the analytical method nor its accuracy and precision were reported.  Thus, the reported LBDE concentrations are questionable. 

Orihel et al. (2009) and Muir (2011).  The work reported in Orihel et al. (2009) was an uncontrolled open-air experiment that attempted to determine changes in concentrations at ng/g levels.  A commercial DecaBDE product was used as test material.  Its composition was not determined.  The test material was sprayed-applied to a lake’s surface, and sediment was sampled at intervals.  These lake ‘mesocosms’ were subject to significant perturbation of the air, water, suspended sediments and sediment due to winter storms.   This work is not sufficient for use as the basis regulatory action.

The work reported by Muir (2011) was done in an effort to rectify some of the problems with the open-air lake mesocosm study.  Tubes containing sediment spiked with unlabelled and 13C-BDE209 were incubated under aerobic or anoxic conditions in the light or in the dark beneath the surface of a lake.  In a poster presentation of the results, Orihel et al. 2011 concluded “using the current analytical approach [e.g. for unlabelled DecaBDE and potential transformation products], it is not possible to conclude with confidence that lower-brominated BDEs were formed from deca-BDE debromination”.  Thus, it is difficult to understand how the Annex XV dossier relies on this work.	

Huang et al. (2010).  These results do not provide evidence that BDE 209 degrades to any significant extent.  Recovery of BDE209 from planted soil was within the range of the matrix spike.  Roughly 20% of BDE 209 was not recovered from planted soil, plants, or pots as the parent molecule or degradants.  High binding of BDE 209 to particulates is expected and likely accounts for the unrecovered fraction.  Presumed degradants were a small fraction of the BDE209 dose, and the 3 hexa- and heptaBDEs reported an even smaller fraction of the dose.  All prior data indicates biodegradation of BDE-209 within a 60-d window is improbable, and would not be expected under aerobic conditions.  
•	Sellstrom et al. (2005) reported no evidence of DecaBDE’s degradation in farm soils amended with sewage sludge or river flooding. 
•	Nyholm et al (2010) reported no biodegradation of BDE 209 in aerobic or anaerobic soil over a 160 period.  A half-life of > 360 or 400 d was estimated.
•	Liu et al. (2011) reported no degradation of BDE 209 was observed in aerobic soil over a 180 d period.  

A total of 18 values for the three hexa- and heptaBDEs, BDE 138, 153, 154, were reported (Table S3).  The 3 congeners were not detected in 11 of 18 measurements.  Five of the 18 values were > 0.1% of BDE209’s starting concentration.   All 5 were <1.5% of the starting concentration.
•	BDE138 was not detected in 4 of the 6 soils.  Two soils were reported to contain BDE 138 at 1.2% or 0.09% of DecaBDE’s initial concentration.
•	BDE 153 was not detected in 4 of the 6 soils.  Two soils were reported to contain BDE 153 at 0.016% and 0.88% of DecaBDE’s initial concentration.
•	BDE 154 was detected in 4 of the 6 soils ranging from 0.03% (n=1) to 0.39-0.47% (n=3).  

OTHER STUDIES.  The short review period for the 217 page Annex XV dossier does unfortunately not allow adequate assessment of all studies mentioned in the dossier, while the limited form makes in-depth analysis difficult.    

Regarding transformation in biota, the science has further developed, but unfortunately ;the Annex XV dossier repeats incorrect interpretations from previous reviews. In this context we refer to publications by Hardy et al. (2009) and Bieseimer et al. (2011)  for the interpretation of the following references: Morck and Klasson Wehler (2001), Morck et al. (2003), Sandholm et al. (2003), Huwe (2005), and Huwe and Smith (2007).  Huwe et al. (2007) estimated 1% of a total BDE 209 dose appeared metabolized to 1 nonaBDE and 2 octaBDEs.  Hardy 2012 commented on the McKinney et al. 2011 in vitro study.   Key new information is:
•	Steady-state levels are achieved within 14 consecutive daily doses (Biesemeier et al. 2011).
•	DecaBDE has low systemic bioavailability.
•	DecaBDE’s absorption from the gastrointestinal tract is diffusion-limited.  Blood levels are comparable at oral doses of 10 (and possibly as low a 2) to 1000 mg/kg/d (Biesemeier et al. 2011). First order absorption kinetics are observed at doses ≤1 mg/kg/d whereas zero order kinetics occur at ≥ 10 mg/kg/d.
•	DecaBDE’s elimination is not reliant on metabolism.  Only a small fraction of an oral dose is absorbed, where upon it is transferred to the liver and eliminated in the bile as the parent molecule.  A smaller fraction of that absorbed undergoes systemic circulation and on subsequent passes is eliminated in the bile, again without prior metabolism.

Time does not allow for detailed comments.  Discussion of DecaBDE’s purported metabolism is unwarranted in the face of multiple studies with NOEL/NOAELs of 1000 mg/kg/d, three lifetime dietary studies, and an oral reference dose of 4 mg/kg/d.  

The Annex XV dossier’s comment that the egg injection study may mean DecaBDE’s potential for toxicity in wildlife should be deleted.  This study is irrelevant to wildlife.  Multiple repeated dose studies up to and including lifetime exposures at very high doses demonstrate DecaBDE’s lack of toxicity.	As described in the dossier, there does appear to have been an increase in the levels of the hazardous PBDE congeners, especially at the highest loading rate in the Schaeffer and Flagg study. The high analytical variability is unfortunate. Even though the study was performed in accordance with the relevant guideline, it does not allow a detailed consideration of debromination for this reason.

Whilst the OECD 308 Test Guideline is the standard method, it has never been ring-tested as far as we are aware, and as pointed out above, significant variation in the test chambers hindered efforts to establish the extent to which lower PBDE congeners were formed. In addition, the mean concentration of decaBDE appeared to increase by 12% during the test at the highest loading. So, just because a study has followed a specific guideline does not always mean that the results can be used with confidence. In addition, there are no standardised guidelines for either the mesocosm or greenhouse experiments. However they do appear to have been designed appropriately, so this should not prevent their consideration. GLP is part of the quality control system in place to ensure mutual acceptance of data between OECD countries. A lack of GLP does not necessarily invalidate study results.

We would consider the mesocosm study to be ‘non-assignable’ at present. We have gone to some lengths to check the findings with the original research group, and they have confirmed that our text is accurate. We clearly mention that there is no full study report, which makes it impossible to use the results to the extent we would like. However, we understand that a report may never be produced, for various resource-related reasons, and we do not think this means the results should be ignored entirely. As mentioned above, we have included a brief discussion of analytical issues in the dossier. However, the analytical work was performed in an experienced laboratory, so this lessens our concern in this case.

The purity of the test substance in the Huang et al. study is not stated in the journal article, but the study included controls both without plants and without decaBDE, which provides reassurance that the lower PBDEs were not present in detectable amounts in the test material. We agree that the analytical method was non-specific. However, Industry has not offered any plausible alternative explanations for what substances might have been eluting. We recognise that radio-label would have produced results that are less open to challenge, but this was not done. This study was published some time ago, and, given the results, Industry has had time to perform further investigations of its own to resolve some of these questions.

This study is the closest we can get to natural conditions, but we accept that it is far from perfect. Nevertheless, elevated concentrations of lower PBDEs were found in fish compared to controls. We can only conclude that the treatment (i.e. addition of decaBDE) was the cause.

The additional sediment core studies were, we were told, intended to help explain the findings of the main study, rather than ‘rectify problems’. We note that these tests were much shorter in duration than the main experiment, so although the authors considered the results equivocal, this does not invalidate the results from the longer experiment.

The Huang et al. study appears to show the formation of lower PBDE congeners that were not present at the start of the test or in the controls. Industry does not provide any other plausible explanation (they simply say it is ‘improbable’). 

Since the other cited studies involved soil exposure only, the comment misses the point that it seems to be the presence of plants that makes the difference. In any case, the other studies indicate long half-lives for primary degradation – this does not mean that lower PBDE congeners were not being formed in small amounts (they were not looked for).

We have added details of the Viganò et al. (2011) study to the dossier. 

We appreciate that the commenting period and format are not ideal for such complex cases. However, much of the argument had been made previously by the UK Advisory Committee for Hazardous Substances in its review published in 2010. 

Thank you for pointing out the additional references. Mammalian toxicokinetics is not a key issue for this dossier, so has not been discussed in extensive detail.  Given the apparently extensive uptake by Grey Seals, we are cautious about drawing conclusions from rodent studies to other mammals present in the environment.

The 'multiple repeated dose' studies referred to in the comments are mammalian. We know that levels in the eggs of some wild bird species approach those used in the egg injection study. Whilst we would agree that this method of administration does not provide an environmentally relevant exposure route, the toxicological findings are of concern, and we do not think they should be dismissed lightly. We are not aware of any standard test guideline avian toxicity studies with decaBDE.	
			See also:
Comment 18 attachment (VECAP 2011 report EU + references quoted.zip).zip		
14	2012/10/17	National NGO
CHEM Trust
United Kingdom	We strongly agree with the proposed reasoning for the justification that the transformation of decaBDE to PBT/vPvB substances warrants inclusion in the candidate list. Scientific evidence for this has been available for over a decade and regulatory action  is long overdue.
Even though the focus of the dossier is on the PBT/vPvB assessment and environmental effects we suggest to refer to some of the findings of decaBDE in humans and related concerns for human health impacts (in particular  potential developmental neurotoxic effects) described elsewhere.  	The focus of the dossier is the environment. We are not in a position to review further studies for end points that have not been included. The French authorities are updating the human hazard assessment and we await their conclusions on the potential human health impacts.	
13	2012/10/16	National NGO
The Cancer Prevention & Education Society
United Kingdom	Based on its potential to transform to more hazardous substances in the environment	No response needed (partial sentence – is part of this comment missing?).	
4	2012/09/20	Other contributor
FRETWORK The flame retardant textiles network ltd
United Kingdom	see general comments	No response needed.	
3	2012/09/19	International NGO
ChemSec
Sweden	It has been well known for many years that Deca-BDE has the potential to bio-accumulate and persist in nature for long periods of time as well to transform to lower brominated congeners. In the justification it seems like the properties not related to PBT/vPvB properties such as Deca-BDE's developmentally toxic and endocrine disruptive effects which is needed as background information in the assessment of the SVHC properties have been set aside and not further explored nor highlighted.	Although decaBDE bioaccumulates it does not meet the REACH Annex XIII criteria in our opinion. Human health hazards were not explicitly considered in the preparation of this dossier because we believe that the evidence is already sufficiently strong to identify it as an SVHC. The French authorities are assessing the potential developmental toxicity of decaBDE but their conclusions have not yet been made public. In addition, there is no currently agreed definition of endocrine disruption for the purposes of REACH.	
1	2012/09/17	Trade union
European Trade Union Confederation
Belgium	DecaBDE is listed in the Trade Union Priority List for REACH authorisation see http://www.etuc.org/a/6023	No response needed.	

PART II: Comments and responses to comments on uses, exposures, alternatives and risks

Specific comments on use, exposure, alternatives and risks
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
26	2012/10/18	Industry or trade association
Aerospace Industries Association
United States	See attached document	Thank you for your comments. This information can be taken into account during the prioritisation process if this substance is added to the Candidate List.	
			See also:
Comment 26 attachment (ECHA deca SVHC consultation oct 18 2012.docx).docx		
24	2012/10/18	Member State
Norway	p 157 Other (uses); Concerning use investigations by Norwegian Authorities have identified some products that are still on the market where DecaBDE has been added in the adhesive layer of reflective tapes on work wear which are used as fire fighter uniforms, by the staff at oil platforms, in the energy sector etc . The reflective tapes contained decaBDE from 1 to 5 % (weight % of reflective material.
p 162 emissions; This use in adhesive in the reflective tapes on some work wear has been shown to lead to significant emissions of decaBDE to the aquatic environment. Environmental monitoring in Åsefjorden in the Ålesund area has shown presence of brominated flame retardants. High levels of BDEs, especially the fully brominated congener decaBDE, and HBCDD have been measured in marine sediments. (Berge et al 2009) The HBCDD source was quickly found and emissions reduced. Efforts to find the source of BDE contamination has been ongoing since the first monitoring study in 2005.  
Analysis of waste water from one large laundry gave a positive result. This laundry is a major cleaner of flame retardant work wear which are used as fire fighter uniforms, by the staff at oil platforms, in the energy sector etc.  Further XRF screening showed presence of bromine in work wear that was washed or cleaned at this laundry, and more specifically in the reflective tapes on the work wear. 
The reflective tapes on many different garment brands were sent to analysis, and a total of three different tape brands have been identified to contain decaBDE.  DecaBDE has been added in the adhesive layer of the tapes.  Different analyses show different quantities of decaBDE; results vary from 1 to 5 % (weight % of reflective material).
Migration tests were performed by the Norwegian manufacturer.  Reflective tapes were washed repeatedly and the content of decaBDE was determined in the washed reflective material. The migration tests indicate that 10-30% of the flame retardant is lost over the service life. 
References:
Berge, John Arthur, Borgå, Kathrine, Enge, Ellen Katrin., 2009. Analyse av sedimenter: Kildesporing av bromerte flammehemmere i Ålesundsområdet. Klif rapport TA-2441/2009	Thank you for the additional information. This can be taken into account during the prioritisation step if this substance is added to the Candidate List.	
19	2012/10/18	Company
Italy	SEAM/914/REACH

USES AND EXPOSURE pag142 and pag162

Our Company uses DecaBDE as material for Flame Retardant production strictly in closed loop.

Our Company operates in accordance with the requirements of the Integrated Environmental Authorisation (AIA DD No. 11962 19/12/2007) issued by the Region of Umbria and in compliance with Directive 2010/75/EC (IPPC).
The authorization provides for DecaBDE control plans on all operational and environmental aspects (emissions, waste, water treatment, underground, mass balances, etc.), and requires scheduled and unscheduled audits by the Supervisory Authorities (ARPA, etc.).

Until today, there have never been non-compliances.
Our Company uses DecaBDE since 1975 and has never had any accident, injury or illness related to the handling and management of DecaBDE.Our Company has never had problems with stakeholders (e.g. Resident population, Trade Unions, Supervisory Authorities, etc.) and the production site is far from urban settlement.Our Company is certified according to :
- ISO14001 (Environmental Management System);
- SA8000 (Social Accountability);
- Standard GHG41 CMS (Carbon Neutrality);
- Oeko-Tex (Eco-compatibility of textile products in contact with skin);
- ISO9001 and ISO TS 16949 (Quality Management System);
- BS OHSAS18001 (Safety Management System).

Our Company uses DecaBDE because it is the only effective substance for Flame Retardant which has the technical features for production process. At this time, this substance is impossible to replace. The management of DecaBDE occurs in closed-loop systems according to the current BAT.

Our Company's products are highly technological and sold throughout the world. The impossibility of using DecaBDE will cause the loss of relevant part of Flame Retardant textile market and maybe also the relocation of this production outside the EU.

As discussed above, our Company requires that DecaBDE will not be included in Candidate List.

CURRENT KNOWLEDGE ON ALTERNATIVES pag167

Please consider also that the research project (already started), for the replacement of DecaBDE in the production process will require at least 5 years and will need for a substantial investment for its implementation.	Inclusion of substances on the Candidate List does not prevent their continuing use. If the substance is added to Annex XIV at a future date, it will be necessary to obtain an authorisation for uses that continue beyond the sunset date. In the case of decaBDE it is likely that authorisation applications will need to be assessed via the socio-economic route. The assessment process will take into account the societal benefits that are gained from use, whether or not suitable alternatives are available or are in development and the timescale required to move to these alternatives. Information on the control measures that are in place at sites where decaBDE is used can be provided in applications for authorisation as evidence of the steps being taken to minimise emissions. 	
			See also:
Comment 19 attachment (Comments for Annex XV SVHC Dossier DecaBDE - Part IV (ECHA) (eng)  ott12.doc).doc
CONFIDENTIAL attachment removed.		
18	2012/10/18	Company
Albemarle Europe SPRL
Belgium	The three main producers of DecaBDE are committed to a safe and environmentally sound management of chemicals worldwide and have applied the Voluntary Emission Control Action Programme (VECAP) inter alia to DecaBDE to successfully reduce emissions along the supply chain. Significant reductions in emissions were reached through this pogramme during the seven years of its application. The latest Annual Progress report is attached to this submission.

The Annex XV dossier, page 164, discusses the on-going DecaBDE environmental monitoring conducted as an outcome of its 2004 EU assessment, and opines that the effects of the VECAP program should be reflected in the monitoring data.  Because no apparent trend is evident, the dossier states that VECAP must not capture the most significant emissions or has not succeeded in reducing emissions sufficiently.  These statements do not take into consideration the following facts: 
•	The year 2011 marked the 7th year of the monitoring program.  Olofsson et al. (2012) reported that on average, 12 years was needed to track an annual change of ± 10% for the 77 substances analyzed.  Thus, a detectable trend would not be expected in the DecaBDE monitoring program at this point in time.
•	A trend cannot be detected when levels are at background or below the limit of detection and/or quantitation (LOD; LOQ).  For example, DecaBDE was not detected in 2 of 6 2011 sparrowhawk eggs and between the LOQ and LOD in another 2.  In 2011 gull eggs, DecaBDE was not detected in 6 of 7 eggs.  Notably, Leslie et al. (2011) found no significant temporal trend between 1973 and 2001 in DecaBDE levels in sparrowhawk muscle.
•	The most appropriate samples may not have been included: peregrine falcon eggs had a significant increase between 1975 to 1995, followed by a significant decline from 1995 to 2001 (Leslie et al. 2011).
•	The unusually high 2009 sediment concentration in 1 UK sediment was ca. equal to that of 2007 when measured in 2011.  The 2011 River Mersey sediments had ca. half the amount of DecaBDE as in 2009.	We accept that the available data do not permit conclusions to be drawn on the trends of decaBDE in the wider environmental from a statistical point of view. However, they do indicate that emissions are ongoing, and given the (very) large reductions in point source emissions from the VECAP, this suggests to us that other sources are still important.	
			See also:
Comment 18 attachment (VECAP 2011 report EU + references quoted.zip).zip		
14	2012/10/17	National NGO
CHEM Trust
United Kingdom	Chapter 2.2.1
Flame retardants, which are used to prevent or slow the rate at which fire takes hold may save lives in certain applications, but there is reason to assume that the societal need is generally overestimated. This over-use is considered to be a direct result from the influence of certain industry circles. For more information and useful insight please see this recent series in the Chicago tribune: http://www.chicagotribune.com/news/watchdog/flames/ct-met-flames-tobacco-20120508,0,3332088.story  and here http://www.chicagotribune.com/news/watchdog/flames/ct-met-flames-science-20120509,0,2480120.story

Chapters 3.2 – 3.5
The VECAP programme from industry was set up to fail by design: It only covers the manufacturing phase, but most of the emissions  result from  use and disposal. Moreover, VECAP only works with estimated emissions rather than analytical measurements. 
Given that there are no trends in reduction over the last 8 years since VECAP started it can no longer be argued that potentially “insufficient time has elapsed” or there is still a lack of participation of companies. In our view the conclusion can only be that VECAP was never sufficient to significantly reduce the environmental burden. This makes the proposal for inclusion of deca-BDE in the REACH candidate list so important.
	If the substance is added to Annex XIV at a future date, it is likely that authorisation applications for decaBDE will need to be assessed via the socio-economic route. The process for granting authorisations takes into account the societal benefits that are gained from use. The socio-economic arguments that are presented to justify continued use will be scrutinised by ECHA’s Socio-Economic Assessment Committee.

The VECAP successfully reduced emissions from some point sources. However, the level of emissions from other sources has never been fully established. We agree that the environmental monitoring data suggest that these other sources are significant.	
10	2012/10/15	Company
ICL-IP
Israel	p. 170-171, Table 19:
1.	Tetrabromobisphenol A; TBBPA is not used in PBT/PET. PBT/PET should be deleted from the list.
2.	Tris(tribromophenoxy) triazine is not recommended for application in PE and is not used in PBT. PE and PBT should be deleted from the list.
3.	Resorcinol bis(diphenyl phosphate); RDP is not recommended for use in PET, polybutylene terephthalate, PA. PET, polybutylene terephthalate and PA should be deleted from the list.
4.	Melamine cyanurate is not recommended for use in HIPS, PP, HIPS/PPO, PE/EVA. HIPS, PP, HIPS/PPO and PE/EVA should be deleted from the list.
5.	Melamine polyphosphate is not recommended for use in HIPS, HIPS/PPO. HIPS and HIPS/PPO should be deleted from the list.
p. 172, 2nd § line 5:  The sentence “Non-halogenated systems have an advantage over halogenated systems in that they have a lower potential to generate toxic combustion products during a fire.” is wrong according to several scientific publications indicating the contrary. Here are few of them:
1.	Evaluation of Ecotoxicological properties from incineration of new Duroplastic Materials without Halogen as Flame-Retardant - D. Lenoir, O. Hutzinger et al - Institute of Ecological Chemistry, GSF-Research Center - D-85758 Oberschleissheim and Chair of Ecological Chemistry and Geochemistry, University of Bayreuth, D-95440 Bayreuth - Germany. BCC Conference 94.
In this publication, it is mentioned that the halogen free flame retardant system is releasing very toxic cyanic acid during incineration test simulating a fire.
2.	Mise en évidence de cyanure dans les gaz produits par l’inflammation du polystyrène choc ignifugé  E. Gaudin, C. Rossi et al - Laboratoire de Chimie macromoléculaire, Université de Provence, Marseille - France - 6th European Meeting on Fire Retardancy of Polymeric Materials - Lille, September 24-26 1997. p. 180.
3.	N. Milanov, K. Doods, K.W. Schramm, G. Matuschek, D. Lenoir & A. Kettrup, Comparison between Halogenated & Phosphorus-Containing Flame-Retardants in Polybutyleneterephthalate: Toxicological & Ecotoxicological Evaluation of the Combustion Products, Organohalogen Compounds, 2002, 55, 402. 
This publication is showing that the toxicity of the combustion products from PBT fire retarded by a polymeric brominated fire retardant system is several times less than for PBT flame retarded by diethyl phosphinic acid salt of aluminum that emits toxic smoke during incineration.

4. Red phosphorus (mentioned in p. 179, Table 20) is known for its potential release of very toxic phosphine under fire conditions.
I highly recommend deleting this sentence
p. 172  under Phosphorus based additives 2nd § add after the last sentence: “For applications where high thermal processing stability is needed, for instance in glass reinforced polyamide 6,6, phosphinate flame retardant based systems are toxic to aquatic organisms and may cause long-term adverse effects in the aquatic environment. ” (ref. is attached: MSDS of Exolit OP1314)
p. 173 under Other 2nd§, 6th line: the use of urea/melamine in HIPS is not known in the market and, consequently it is suggested to delete the following “(e.g. urea/melamine in HIPS)”.
p. 175, 3rd§, 7th line, tris(tribromophenyl) triazine is not recommended for application in synthetic fibres. And it is suggested to remove it from the list.
p.176, 2nd§, 5th line, NORTM 116 (CAS 191680-81-6) is also used together with tribromoneopentyl phosphate and it is suggested to replace or by and/or.	Thank you for the information. This list is indicative only, and can be revised during the prioritisation step if decaBDE is added to the Candidate List.	
			See also:
Comment 10 attachment (MSDS Exolit OP 1314_en.pdf).pdf		
9	2012/10/15	Company
ICL Industrial Product (ICL-IP)
Israel	p. 144 Fig. 8: I suggest to complete the box with Injection by adding /Extrusion/Calendering.
p. 145 in § 1. Polyolefins: delete polypropylene ether (PPE); PPE stands for polyphenylene ether alias PPO, polyphenylene oxide and this is not a polyolefin. (see http://en.wikipedia.org/wiki/Poly(p-phenylene_oxide) )	Thank you for the information. These amendments can be made during the prioritisation step.	
8	2012/10/15	Industry or trade association
ASD - Aerospace and Defence Industries of Europe
Belgium	Used as a flame retardent in Aerospace/Defence applications. Used as alternative to other PolyBrominated Diphenyl Ethers, as a less toxic alternative. In some applications there may be no available alternatives. Fire resistance is a growing product safety issue, especially with the increasing weight of polymers in aircraft. Additional regulation of production in the US adds urgency to this, production in Europe stopped some time ago. Industry transition is happening slowly in any case without additional push from candidate listing - additional regulatory pressure is unnecessary.	The authorisation process will enable applicants to make a case for continued use. In the case of decaBDE it is likely that authorisation applications will need to be assessed via the socio-economic route. The assessment process will take into account the societal benefits that are gained from use, whether or not suitable alternatives are available or are in development and the timescale required to move to these alternatives. 	
4	2012/09/20	Other contributor
FRETWORK The flame retardant textiles network ltd
United Kingdom	See general comments	See response to general comments.	
3	2012/09/19	International NGO
ChemSec
Sweden	Deca-BDE has been used for a long time and can be found virtually everywhere. The exposure to the general public as well as for wildlife is hence large and need to be drastically reduced, why a restriction on the use of Deca-BDE in imported articles should be put in place following the inclusion of Deca-BDE in the candidate list and Annex XIV.	This is a risk management issue. Substitution for some applications may be complicated. The need to restrict decaBDE in imported articles can be decided once the authorisation process has been allowed to work, if the level of imported articles containing decaBDE suggests this is necessary.	

Attachments

Comment number	Public attachment	
10	
Comment 10 attachment (MSDS Exolit OP 1314_en.pdf).pdf	
17	
Comment 17 attachment (STATEMENT_MONBAT+START.doc).doc	
18	
Comment 18 attachment (VECAP 2011 report EU + references quoted.zip).zip	
19	
Comment 19 attachment (Comments for Annex XV SVHC Dossier DecaBDE - Part IV (ECHA) (eng)  ott12.doc).doc	
22	
Comment 22 attachment (20017_2012_Echa_54 SVHC consultation.pdf).pdf	
26	
Comment 26 attachment (ECHA deca SVHC consultation oct 18 2012.docx).doc