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

Substance name:	Heptacosafluorotetradecanoic acid	
CAS number:	376-06-7	
EC number:	206-803-4	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: 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. RCOM has not been agreed by the Member State Committee nor has the document been modified as result of the MSC discussions. 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	
13	2012/10/18	International NGO
Health and Environment Alliance
Belgium	We support the nomination of this chemical to the Candidate List.	Thank you for the support.	
12	2012/10/18	European institution
European Chemicals Agency
Finland	Overall, the submitted Annex XV SVHC dossiers for the C11-C14 PFCAs, all four being based on the same set of information and the same approach for assessing the PBT properties, raise in their present form some questions, which are addressed in specific comments in more detail. 
Considering the assessment methodology recommended in the ECHA guidances, it appears advisable to enhance the dossiers with regard to the detail of information and analysis provided and to include further information available in the public domain, such as the review of the Canadian authority (available under http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/pfca-apfc-eng.php), into the dossier to increase the body of evidence for especially persistence and then to conclude on such expanded weight-of-evidence basis.
Furthermore, the presentation of the study results and other relevant information in all subchapters would benefit from systematic consideration of the influence of the surface active properties of the substances on the PBT-assessment and on the reliability of the studies and the other relevant information.	Thank you for your comment. The Canadian report was included.	
11	2012/10/18	Member State
Norway	We would like to thank Germany for preparing these comprehensive documents. 
The Norwegian CA supports that Henicosafluoroundecanoic acid (PFUnDA, C11-PFCA,CAS no 2058-94-8), Tricosafluorododecanoic acid (PFDoDA, C12-PFCA, CAS no 307-55-1), Pentacosafluorotridecanoic acid (PFTrDA, C13-PFCA, CAS no 72629-94-8) and Heptacosafluorotetradecanoic acid (PFTeDA, C14-PFCA, CAS no 376-06-7) should be identified as substances of very high concern and should be included in the Candidate List based on their very persistent and very bioaccumulating properties (article 57 e). The wide spread occurrence of these substances in humans and in wild life, including in the Arctic, and in particular the increase in the levels of long-chained PFCAs that has been documented for a number of species during the past decades cause very high concern.
We agree that the read-across approach is fully justified based on the structural similarities and the physico-chemical properties, which follow a regular pattern. 	Thank you for the support.	
10	2012/10/17	Member State
Sweden	Sweden agrees with the German proposal to identify heptacosafluorotetradecanoic acid as a vPvB substance according to Article 57(e) of REACH. 	Thank you for the support.	
9	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 Heptacosafluorotetradecanoic acid 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 the support.	
8	2012/10/17	National NGO
CHEM Trust
United Kingdom	CHEM Trust supports the inclusion of Heptacosafluorotetradecanoic acid in the REACH candidate list due to its vPvB properties. We also welcome the fact that four similar PFCAs have been proposed for nomination at the same time in order to avoid replacement with one another.  However, we consider that regulatory action is needed also on other similar PFC compounds that are currently not covered.	Thank you for the support.	
7	2012/10/17	Member State
United Kingdom	The proposal is put forward according to REACH Art 57(e). This is appropriate as the vPvB criteria of REACH Annex XIII are met based on the weight of available evidence, including a measured fish BCF >5000 L/kg.

The substance has not yet been registered under REACH. Other substances that act as precursors (e.g. with different “head groups” or linear polymeric telomer materials) may exist and be on the market in the EU. These may actually be a bigger source of the substance in the environment through degradation. It will be important to identify such materials (including the level of imports in articles, if possible), and a dialogue with industry is needed to do this so that the most appropriate risk management measure can be determined. (The recent Environment Canada final ecological screening assessment has a useful summary of information – see below.) 

Since we have had limited time to review the publications referring to the biomagnification and trophic magnification potential of the substance, we would have preferred a detailed discussion at the PBT Expert Group in advance of this submission. This could have helped ensure consistency in the way ‘higher tier’ B measures are reported and interpreted for example. Nevertheless, given the high BCF result, we can accept the vB conclusion in this case. 

Please ensure that details of studies contained in the report are (at least) included in the robust study summaries. For example, for the summaries of the Martin et al BCF/BMF/TMF papers, some details appear in the report but are not included in the RSS, and some important details are missing entirely.
	According to your comments the summeries of the studies have been amended. Additionally, a more critical analysis has been added concerning uncertainties especially referring to field studies.

We totally agree that precursors are of importance when addressing environmental exposure of these chemicals. As states in the RMO-Analysis we will address precursors in upcoming regulatory steps. 

There has been a workshop at the German Federal Environment Agency in November 2011 (before the PBT EG has been established), where the “higher tier” B assessment has been discussed focussed on C8 PFCA but including also other PFCAs. 	
6	2012/10/16	National Authority
IEW
Belgium	We support the nomination of this chemical to the Candidate List as a substance of very high concern	Thank you for the support.	
5	2012/10/16	Member State
Belgium	This perfluorinated carbon chains (C11-C14) is to be identified as vP based on read-across data with the C8 chain. Furthermore, information is available that the C11,C12 and C14 chains are to be identified as vB and due to read-across to these results also C13 can be identified as such 	Thank you for the support.	
4	2012/09/25	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 the support.	
2	2012/09/19	International NGO
ChemSec
Sweden	We support the identification of this highly fluorinated substance as a SVHC.	Thank you for the support.	
1	2012/09/19	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of Heptacosafluorotetradecanoic acid as SVHC.	Thank you for the support.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/
MSCA)	Comment	Response	
12	2012/10/18	European institution
European Chemicals Agency
Finland	Assessment of degradation, persistence (sections 3.1.2.1.3, 3.1.2.4, 3.1.3, 6.1 and overall summary justification under section “Proposal…”)
Taking into account the relevant ECHA guidances, there appears to be a need to enhance and further strengthen the assessment of persistence. Based on Section 2 of Annexes XV to REACH and Sections 2.2 and 3.2 of Annex XIII, it appears necessary to include in the dossiers relevant “assessment information” as described in Section 3.2 of Annex XIII to REACH, which then needs to  be compared with the Annex XIII criteria for the identification of PBTs or vPvBs.
The reported aerobic biodegradation test data, which can be regarded as “assessment information” in the meaning of section 3.2 of Annex XIII to REACH, have been flagged in the dossiers as ‘non-reliable’ or as ‘reliability not-assignable’ (section 3.1.2.1.3). Furthermore, it is unclear whether these tests have been conducted at conditions that are relevant for the assessment of persistence. However, reference is made to these data in the conclusions and summary justifications of the dossiers without further reasoning as to why these studies provide a suitable basis for drawing conclusions. The only “assessment information” on biodegradation flagged as reliable is for anaerobic biodegradation (study of Liou et al. 2010). The relevance of information on anaerobic biodegradation for PBT assessment is however uncertain (see, e.g.,  PBT assessment of hexabromocyclododecane, background document of ECHA’ decision ED 67/2008) and in the submitted dossiers specific reasons are not provided as to why anaerobic biodegradation results would be relevant in the cases of the C11-C14 PFCAs. 
The submitting authority has further cited monitoring studies from contaminated sites as supporting evidence for persistence (soil, groundwater). However, the level of detail presented in the Annex XV dossiers on these studies does not seem to allow the reader to judge whether these studies are suitable as supporting evidence in the PBT assessment. Use of monitoring results from contaminated sites would be more convincing if, for instance, the impact of the concentration level on the ability of the microbes to biodegrade the high concentrations often present at contaminated sites would be addressed. In addition, a description of the mass balance over time, from the perspective of analysing whether the monitoring results are indicating dissipation (from a large contamination “hot spot” or from one contaminated compartment to another) rather than degradation, could be included. Furthermore, it would be of advantage to report the concentrations for the whole monitoring period.

Read across justification
All “assessment information” in the dossiers, as described in section 3.2 of Annex XIII to REACH on biodegradation, is on C8-PFCA or its salts only. Screening biodegradation studies are available mainly for C8-PFCA and one study each for C12-PFCA and C14-PFCA. Also, for abiotic degradation the conclusion relies on information for C8-PFCA. 
The justification for read across in the dossiers is based on
(1) structural similarity ( the only difference between C8- to C14-PFCAs is the carbon chain length) 
AND
(2) PC-data presented in section 1.3 and Annex I of the dossiers.   
These PC-data, as currently presented in the dossiers, appear to have a rather poor coverage. Furthermore, most of the PC-data relevant for especially the assessment of persistence (solubility, partitioning) has been derived using a QSAR-software. As the assessed C11 – C14 PFCAs are surface active, for which most of the QSAR-models are not applicable, the dossier would benefit from discussion on the applicability of the used QSAR-models and the validity of the estimates. Furthermore, the reported values of water solubility for C8-PFCAs (PFOA, APFO, NaPFO) in Annex I of the dossiers, which seem to be the only “reference values” for water solubility for the substance group, do not indicate for which pH the values are applicable. As the substances are weak acids, partitioning and water solubility may depend significantly on the pH. Therefore, for a read across justification based on PC-data, it appears advisable to report the pH-values or normalise all the values presented to the same pH.	Section 3.1.2.
In the environment aerobic as well as anaerobic conditions occur. Hence, the biodegradation should be assessed under both conditions. Even if no reliable study under aerobic conditions is available, in sum the mentioned studies support that the PFCAs are not biodegradable. 
The section has been revised.

The partitioning data used as a basis for the read-across approach are calculated using COSMOtherm. COSMOtherm is a quantum chemistry-based method that requires
no specific calibration. This calibration would be difficult because of missing measured data of PFCAs. Therefore COSMOtherm is expected to be able to
estimate properties for PFASs. A study (H. P. H. Arp, C. Niederer, K.-U. Goss, Predicting the partitioning
behavior of various highly fluorinated compounds. Environ. Sci.
Technol. 2006, 40, 7298. doi:10.1021/ES060744Y)has shown that properties estimated
with COSMOtherm showed good agreement
with the experimental data for a limited number of PFCAs. This information has now also been included in Annex 1 of the support document. 

Solubility data are already reported in dependence of the pH in Annex 1 of the Dossiers. 	
11	2012/10/18	Member State
Norway	p 31 Summary and overall conclusions on the PBT, vPvB properties; We agree that the persistency of these compounds is well documented. The scientific knowledge of the physical and chemical properties of these fully fluorinated alkane compounds documents their persistency.  The persistency is further supported by screening studies on several of the compounds and read-across to C8-PFCA for which there is a study confirming a long half-life in water. The persistency is further supported by field monitoring studies from contaminated sites. For the sake of completeness, also estimations of persistency might be included as supporting data. For example, a half-life in water of 2477 days and a half-life in soil of 4954 days were estimated for C9-PFCA (data referred in Lambert et al. 2011).
We also agree that, on a read-across and weight-of-evidence approach, the documentation is sufficient to prove that these substances are very bioaccumulative. 
For some of the PFCA-compounds, e.g C12-PFCA and C14-PFCA , test data are available that shows BCF values above 5000, thus read-across to e.g. C13-PFCA is scientifically justified. Also, according to the revised Annex XIII criteria information such as measured elevated levels in biota, information on the ability of the substance to biomagnify in the food chain, data from analysis of human body fluids or tissues and assessment of toxicokinetic behaviour of the substance, shall be considered as well. For some of the compounds, C11-13-PFCAs, the bioaccumulation potential is documented by monitoring data from food chains, that shows a number of BMF and TMFs that are > 1. 
We would also like to draw the attention to some additional data that indicate that these substances bioaccumulate in humans as well. In a study on ski waxers, elevated concentrations of PFCAs with chain length C9 to C14 were observed and positive statistically significant associations between years exposed as a ski waxer and PFNA, PFDA, PFUnDA, PFDoDA and PFTrDA were observed.	Thank you for the information. We have been added the estimated half-lives to the dossier.

Referring to Bioaccumulation; thank you for your support. We added the suggested “ski waxer”-study.	
10	2012/10/17	Member State
Sweden	We agree with the read across approach taken in this and the other three dossiers provided on the four perfluorinated carboxylic acids: C11-14 –PFCA. We believe that the information given on structural similarities, physicochemical properties, degradation and bioaccumulation in Annex I to the dossiers provide sufficient justification for treating the four substances and the relevant shorter chained PFCAs as a category and applying read-across between the members in the absence of substance specific data for these inherent properties.

Persistence: Considering the scarcity of data on degradability for heptacosafluorotetradecanoic acid Sweden agrees that it is appropriate to use read across from C8-PFCA. The available data show that C8-PFCA meets the vP-criterion of Annex XIII of REACH. Based on the structural similarity, and given that heptacosafluorotetradecanoic acid has been shown to be not ready biodegradable in an OECD screening test there is no reason to believe that heptacosafluorotetradecanoic acid should be more degradable than C8-PFCA.  It is thus justified to draw the conclusion that also Heptacosafluorotetradecanoic fulfills the vP-criterion of Annex XIII.

Bioaccumulation: With measured whole body BCF-values of 16 000 – 23 000 from two studies heptacosafluorotetradecanoic acid unequivocally fulfills the vB-criterion of Annex XIII.	Thank you for the support and your comment.	
8	2012/10/17	National NGO
CHEM Trust
United Kingdom	The read-across approach for P is well-documented and supported, in particular as there are no unequivocal data to the contrary.	Thank you for the support.	
7	2012/10/17	Member State
United Kingdom	We agree with the identification of the substance as an SVHC based on its persistence and bioaccumulation properties. 

Page 4, Summary: There is a statement that sorption increases with chain length but no supporting evidence is presented in the dossier. As this statement is not relevant to the overall conclusion, we wonder whether it would be better to delete it.

Page 7, Section 1.3 (physico-chemical properties): Both water solubility and log Kow (and pKa) have been estimated using QSARs. A statement of the validity of these calculations should be provided (for example, how does the same QSAR perform for better studied substances like PFOS and PFOA?). The relevance of the log Kow value may be questioned as perfluorinated substances tend to form a separate phase when mixed with octanol and water. 

Page 9, Section 2 (C&L): It would be helpful to state that there is no self-classification for environmental hazards in the notification to ECHA’s C&L inventory.

Pages 15-16, Section 3.1.2.1.3 (simulation tests): Please could you provide a reason for the  reliability 3 score for the Meesters and Schroeder (2004) & Schroeder (2004) studies (either in the text or Table 5)? In addition, it is not clear what aspects of the documentation of the Hanson et al. (2005) study are deficient – should this be considered as ‘unknown reliability’ rather than unreliable?

Page 18-19, Section 3.1.2.4 (soil biodegradation): The summary of the Moody et al (2003) study finishes by stating that the substance did not degrade. However, the starting concentrations were not known and it is not clear if potential degradants were analysed for. Is it better to say that this study indicates that “degradation did not appear to occur or was negligible”?

Page 21-22, Section 3.3.1.1 (BCF): It would be helpful to know the dissolved concentration in the NITE (2007) study (was it below the predicted water solubility value, and how close was it to the analytical detection limit)? 

No comment is included in the summary of the Martin et al (2003a) study that other perfluoro- substances have an affinity for protein in blood rich tissues, which could explain the tissue distribution. This should be added as it is important information. The aqueous test concentrations were said to be ‘relatively stable’ – it would be helpful to know how well they were actually maintained.

Inoue et al and Martin et al BMF/BAF studies: We strongly disagree with the use of a laboratory dietary study BMF of 0.31 as indicating a threshold of concern. This value has been derived from nine data points from studies in carp using non-fluorinated substances following a protocol very similar to that agreed for the revised OECD 305 test guideline, simply by plotting lipid-normalised BCF against BMF values. While there is certainly a relationship between BCF and BMF, based partly on similar tissue distribution and depuration kinetics, we don’t think such a simplistic comparison is robust enough to use as some kind of trigger value for widespread use. As Martin et al comment, fish size (as well as species) can have an effect on depuration kinetics (and so on the estimated BMF because of the way the BMF is calculated here). There is clearly a need for further guidance on this topic. For example, the magnitude of the depuration half-life could also be a relevant factor to consider. The depuration rate constants for the two Martin studies are actually quite similar for all four substances; they are almost the same for heptacosafluorotetradecanoic acid for carcass and liver. 

Page 23-24, Section 3.3.1.2 (BMFs): To derive BCFs from the laboratory BMF data, you could try the Sijm allometric equation which only requires a fish weight as an input (since the predicted log Kow is probably not reliable). Using an average fish mass of 7.5g the Sijm equation gives a K1 of 273; this method of estimating uptake rate constants is not meant to be used for specific organs, and it compares poorly with the K1s in the Martin BCF paper of 580 (carcass), 1400 (blood) and 960 (liver) for C12 PFCAs. However, it would still give estimated BCFs of about 13,500 and 9,500 for carcass and liver, respectively, both above the vB criterion, for C14 PFCAs.  

The interpretation of field data in terms of BMF estimation can be complicated. We think that some further information should be provided in the report (e.g. on sample number, sampling location and time, the mean biota concentrations, the number of non-detects, and how these were handled, etc.). In addition, it is not clear whether BMFs based on liver concentrations only (Butt et al, 2008) are comparable to values based on whole body concentrations, and some comment should be added about this. Statements such as “lake trout/prey (weighted)” (Martin et al, 2004) should really be explained, because the reader cannot easily work out what has been done (and whether this was appropriate). The same comments apply for TMF estimates (Section 3.3.1.3). (See also our general comment about the lack of information in the robust study summaries.)

The conclusion of this section (page 25) should be expanded to highlight the uncertainty in all of the field BMFs. 

Page 26, Section 3.3.1.3 (TMFs): Like for BMF, more details are needed about the individual studies (in the report and RSS) and the conclusion should be expanded to highlight the uncertainty in the TMFs (especially owing to differences in time of sampling and trophic level allocation).

Editorial comments
Page 7, Section 1.3: We don’t think it is important to cite the water solubility below pH 4 for the purposes of this dossier. The statement about trend in water solubility with chain length is presumably based on the QSAR predictions rather than actual measured data. We therefore think it would be better to say “The water solubility is predicted to decrease with increasing chain length”. 

Page 10, Section 3.1.1.1: C11-PFCA should read C14-PFCA at end of first paragraph.

Page 11, Section 3.1.1.2: Please update the reference to the final Environment Canada report from August 2012 (see http://www.ec.gc.ca/ese-ees/CA29B043-86E4-4308-BBC0-5CE163FEAC40/PFCAs_EN.pdf).

Page 19, Section 3.1.2.4 (biodegradation summary): A very important “no” or “negligible” is missing from the sentence “…provide evidence that biodegradation in…occurs.”	The statement on increasing sorption with increasing chain length is actually given on page 5. And data supportin that statement are given in Annex 1. The reference to Annex 1 is now included behind that statement. 

We have extended the statement in Annex 1 on the use of QSAR data. 

Section 2: Thank you for the comment. The section has been revised.

Section 3.1.2.1.3: The reason for reliability 3 is significant methodological deficiencies (see also IUCLID).

Section 3.1.2.4 Thank you for the comment. The section has been revised.

Dissolved concentrations for the NITE study have been added. 
Also the summary of the study from Martin et al. has been amended accordingly.

Indeed there is no direct evidence of hepatoxicity of C11 PFCA but for C10 PFCA. However, as the Kudo-study shows there is an increase in observed hepatoxity with increasing chain length. We therefore conclude that for the the structural similar C11-PFCA hepatoxicity can be assumed.

Yes, the calculation based on the linear regression of Inoue et al. is a very rough estimate. Therefore we suggested a reliability of three. To make it more clear we considered your comments in the dossier. We additionally used the suggested Sijm equation to calculate BCF values. With an average fish mass as reported in the Martin et al study we do however get BCF values above 5000.

We included a general discussion on uncertainties concerning field studies.

We added further information concerning the conductance of the study to the summaries.

The figures have been changed and reduced to data from studies which are summarised in the dossier.

Section 1.3: Thank you for the comment. The section has been revised.

Section 3.1.1.1.: Number has been changed
Section 3.1.1.2: Reference has been updated.
Section 3.1.2.4: Thank you for the important advice

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	
11	2012/10/18	Member State
Norway	The global impact of this group of substances is well documented by a large number of monitoring studies showing wide-spread occurrence of PFCAs in biota, including in the Arctic, and in humans (including exposure of foetuses). We would like to draw the attention to some additional publications concerning exposure to humans and wildlife. 
In a literature survey (Økland et al., 2008) PFC data from a large number of Norwegian environmental screening and monitoring surveys are compiled and presented. We would also like to mention results from some Norwegian human biomonitoring studies.  In a study by Haug et al. 2010 concentrations of PFASs were determined in individual samples of serum from men and women between 18 and 79 years with a wide range of seafood consumption (sampled in 2003). In this study the mean concentration of PFNA, PFDA, PFUnDA, PFDoDA and PFTrDA were 1.1, 0.46, 0.72, 0.083, and 0.12 ng/mL, respectively. Consumption of lean fish, fish liver and shrimps were important predictors of serum concentrations for these PFCs
Furthermore, Gutzkow et al. 2012  detected PFNA, PFDA, PFUnDA and PFTrDA in cord plasma with mean concentrations of 0.16, 0.04, 0.06 and 0.07 ng/mL, respectively. Also we would like to draw the attention to the results of a study (Odland, 2006) of pregnant women in Bodø, Northern Norway, and people from indigenous populations in Naryan Mar and Taimyr, Russia, which show that all groups are exposed to PFCAs, e.g.PFOA, PFNA, PFDA and PFUnDA. In particular the women from Naryan Mar had high levels of the long chained PFCAs.  It was indicated that the reason might be high intake of fish. 
Several time trend studies are referred in the Annex XV report showing increasing levels of the long chained PFCAs in biota (fish, seals, polar bears, humans). In an additional new publication this trend is further confirmed.  In the study by Rotander et. al., 2012, temporal variations in concentrations of different PFCs were examined in livers of pilot whale, ringed seal, minke whale, harbor porpoise, hooded seal, Atlantic white-sided dolphin and in muscle tissue of fin whales. The sampling spanned over 20 years (1984–2009) and covered a large geographical area of the North Atlantic and West Greenland. In general, the levels of the long-chained PFCAs (C9–C12) increased over the studied period. 
In a study on ski waxers (Freberg et al. 2010), elevated concentrations of PFCAs with chain length C9 to C14 were observed. Median concentrations (ranges in parentheses) were 13 (3.6-37), 7.5 (2.1-28), 0.96 (0.32-3.4), 2.0 (0.51-9.1), 0.26 (0.11-1.0) and 1.2 (0.26-4.4) ng/mL for PFNA, PFDA, PFUnDA, PFDoDA, PFTrDA and PFTeDA, respectively. This was the first study where PFTeDA was found in human serum. Positive statistically significant associations between years exposed as ski waxer and PFNA, PFDA, PFUnDA, PFDoDA and PFTrDA were observed. The serum concentrations of the PFCAs with carbon chain lengths from C9 to C11 were reduced by around five to 20% on average during the eight month exposure free interval, whereas the reduction was substantially larger for PFDoDA, PFTrDA and PFTeDA. 
References;
Freberg BI, Haug LS, Olsen R, Daae HL, Hersson M, Thomsen C, et al. 2010. Occupational exposure to airborne perfluorinated compounds during professional ski waxing. Environ. Sci. Technol. 44, 7723-7728.
Gutzkow KB, Haug LS, Thomsen C, Sabaredzovic A, Becher G, Brunborg G 2012. Placental transfer of perfluorinated compounds is selective - A Norwegian Mother and Child sub-cohort study. Int J Hyg. Environ Health. 215, 216-219.
Haug LS, Thomsen C, Brantsæter AL, Kvalem HE, Haugen M, Becher G, Alexander J, Meltzer HM and Knutsen HK. 2010. Diet and particularly seafood are major sources of perfluorinated compounds in humans. Environ. Int. 36, 772-778.
Odland, Jon Øyvind: Kartlegging av ”nye” miljøgifter i humane blodprøver fra Nord-Norge, Nord-Vest Russland og Sibir, SFT-rapport TA-2184/2006, 2006.
Rotander, Anna et al.; Increasing levels of long-chain perfluorocarboxylic acids (PFCAs) in Arctic and North Atlantic marine mammals, 1984–2009, Chemosphere, Volume 86, Issue 3, January 2012. Pages  278-285.
Økland, Tom Erik, Skoog, Kristina (2008); Polybrominated diphenyl ethers and Perfluorinated compounds in the Norwegian environment, TA-2450/2008	Thank you for the information.	
7	2012/10/17	Member State
United Kingdom	Page 33-35, current knowledge on alternatives: It is difficult to investigate alternatives when the current uses of this substance (and substances that degrade to form it) are not well known. Differences in use pattern from C8 PFCAs might mean that the same alternatives are not relevant. If possible, more information on uses needs to be collected to carry out a fuller investigation of potential alternatives.

No information on the environmental properties of the alternatives is included; it should be made clear that this assessment has been carried out elsewhere if this is the case.

Editorial comments
Page 42, table 12: The BCF rows for MITI and carp are duplicates; please delete one of these two rows.	Thank you for your comment. 
We are aware about the gaps and will consider them when analysing further risk management options. However please be aware, that the assessment of alternatives is not critical for the SVHC identification.

Page 42: The table has been revised.