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

Substance name: Perfluorononan-1-oic-acid [1], Not applicable [2], Not applicable [3]
EC number: 206-801-3 [1],  Not applicable [2], Not applicable [3]
CAS number: 375-95-1 [1], 21049-39-8 [2], 4149-60-4 [3]

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Toxic for reproduction (Article 57 c); PBT (Article 57 d)

Disclaimer: Comments provided during public consultation are made available 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, submitter type, country)	Comment	Response	
4541
2015/10/15	United Kingdom,
Member State	Biomagnification

1. P25: BMF and TMF between 0 and 1 show a substance is taken up in an organism... We suggest deleting or re-wording this sentence – while we appreciate the point being made (i.e. that (P)B(T) should be protecting all trophic levels) a BMF close to zero is of low concern.

2. P25: Goeritz et al, 2013. Please also include the k2 value for PFNA. We think this is a useful study in the weight of evidence.

3. P25: The bottom paragraph confuses laboratory dietary BMF values with field BMF values. We do not think that they can (should) be compared as the exposure routes are not the same. We agree that experience of the dietary bioaccumulation test indicates that a BMFdiet <1 does not necessarily indicate that a substance is not bioaccumulative, mainly due to the possibility of excretion to clean water. We think the Inoue comparison should be used with considerable care as the correlation only involved 9 substances (none of which were perfluorinated chemicals).

4. P26, Martin et al, 2004. We think there is considerable uncertainty in calculating BMF values for trout sampled between 1980 and 2001, when the prey was sampled in 2002 only. This is a gap of up to 21 years! While we appreciate that the support document includes a discussion about the uncertainty of sampling in different years, the difference here is potentially very large.

5. P26, Tomy et al, 2009.  We agree about the possible over-estimation of BMFs based on organ-specific concentrations (also highlighted in the discussion of Houde et al, 2006). However, we do not think this concern can be disregarded because of the target organ toxicity. BMF values should be compared on a whole-body basis.

6. P26, Houde et al, 2006. The standard error exceeds the mean concentrations in dolphins, and is close to or above it for the fish species. This suggests there is significant uncertainty in the quoted BMF values, which needs to be acknowledged. Table 7 gives this study a Klimisch score of 3 (invalid). It is not clear in the discussion of the study which aspect resulted in this conclusion. It is also unclear how these data were then treated. In our view, invalid studies should (in principle) not be used in a weight of evidence (although some aspects could be relevant, depending on the reasons for non-validity).

7. P27, Butt et al, 2008. The main aim of this paper was the analysis of spatial trends in seal concentrations, rather than calculating robust BMF values. BMF values were calculated using liver concentrations, and from samples taken in different years (and studies). Together, we think these introduce significant uncertainty. The discussion of this study should note Houde et al’s (2006) comment that BMF values calculated from liver concentration can over-estimate whole body BMF values by 10 – 30 times. We think the current results are unreliable and are not sufficiently robust to be included in the main SVHC identification conclusion (p9).

Trophic magnification

8. The introductory paragraphs to the TMF section highlight the uncertainty caused by sample size, but this issue is not discussed for any of the studies subsequently described, and we think this should be done.

9. P30 Houde et al, 2006. We do not think a TMF can be calculated based on plasma concentrations for dolphin and whole fish concentrations. This is not comparing the same types of concentration data, and does not appear to be robust. Similar to the BMF data, the standard error exceeds both TMF values. This indicates that there is significant uncertainty in the quoted values, which needs to be acknowledged. Table 8 gives this study a Klimisch score of 3 (invalid). It is not clear in the discussion of the study which aspect resulted in this conclusion. It is also unclear how these data were then treated. In our view, invalid studies should (in principle) not be used in a weight of evidence (although some aspects could be relevant, depending on the reasons for non-validity).

10. P30, Martin et al, 2004. See comments above under biomagnification.

11. P30, Kelly et al, 2009. According to table 8, the TMF calculation is made using a mixture of data for whole organisms (algae and bivalves), specific tissues (fish muscle and sea duck liver) and estimated whole body (whale). Please discuss the uncertainty for this calculation – as for the Houde et al (2006) TMF calculation the approach does not appear robust. Please also provide details about how the whale concentrations were calculated as there appear to be multiple tissue samples – how were these integrated? We are concerned that there could be significant uncertainty in such a calculation. In addition, there is no mention of the eider duck or seals despite these being sampled. Is this because they were not considered to be part of the same food chain? If so, can calculations be performed for their food chains? Please provide the data for these organisms in the text and the table. As there is no currently agreed method for how protein normalisation is calculated (including the type of protein used, and how this is quantified), we think it is essential to explain the method in the text (or footnote/annex), along with the uncertainties involved.

12. P30, Xu et al, 2014. This appears to be a stronger TMF study than the others. Please provide more detail about the study, e.g. the concentration ranges seen in the different organisms, and the number of non-detects. Please also state the number of night herons and egrets in the food chain.

13. There appear to be extensive uncertainties in the studies. Although some of these are discussed in section 3.3.4, we feel that the significance of the uncertainty for the reliability of a study is less well described. If there are so many uncertainties associated with a study, regardless of the size of the BMF or TMF, there may be insufficient confidence in the result.

14. One major uncertainty is how the whole body concentration is estimated estimation from a specific tissue or organ concentration. This relies on understanding the toxicokinetics for the chemical in the organism. How well characterised are these?

Overall, we are not convinced that any of the studies provide a reliable indication of a BMF or TMF above 1.

Terrestrial bioaccumulation

15. P33: Rich et al, 2015. Please explain how the BAF values were calculated as these are provided in table 9, but only the BSAFs are provided in the text.

16. P33: Zhao et al, 2013 and Rich et al, 2015. Please provide some commentary on the accumulation pattern seen over the different sampling points, and say whether steady state was reached.

17. P33: Zhao et al, 2013 and Rich et al, 2015. We appreciate there are no terrestrial bioaccumulation thresholds, but can you provide some context to the results, for instance by comparing the results to other perfluorinated substances? This might add weight to the category.

18. P33, Muller et al, 2011. We appreciate that the uncertainty regarding sampling in different years is noted. However, is there any evidence to support the claim that the concentrations remain the same across different years? For example what was the variability seen for the concentrations in wolf and caribou sampled in different years? Was this statistically significant? Please discuss the uncertainty in the extrapolations required to calculate the whole body concentration. There appear to be a small number of samples – please explain whether the number of tissue samples represent different animals for wolf and caribou. Given the reference to the concentrations observed in this study in the discussion of the Vestergreen et al paper, it would useful to include some details of these concentrations in the discussion of Muller.
19. P33, Vestergreen et al, 2013. Without some estimate of whole body concentrations it is difficult to determine whether biomagnification has occurred based on only specific tissue concentrations.	

1. The sentence has been reworded. However, also a BMF or TMF below 1 may be of concern as this indicates that a substance is taken up into the organism and the uptake may cause an adverse effect.”

2 .The k2 value has been included.

3. The study of Inoue shows that it cannot be concluded that a substance is not bioaccumulative on the basis of a BMF(dietary)<1. Paragraph has been reworded.

4. Martin et al.: The paper was checked. Trout samples were collected to investigate the time trend of PFOS between 1980 and 2001. The determination of the BMF and TMF values was conducted with the samples from 2001 only (see table 1 Martin et al (2004)).

5. Tomy et al: Comparisons have been made on whole body bases. Nevertheless, from a toxicological point of view, considering that PFCAs show hepatotoxic effects, organ specific accumulation is of concern.

6. Houde at al.: A Klimisch score of three was given for this study, due to a probable point source (WWTP) and non-steady state deriving from this. This has been added to the discussion of the study.

7. Butt et al.: it is discussed that due to tissue-specific concentrations BMFs might have been overestimated.

8. The majority of the field studies mentioned in the comments have been discussed concerning their uncertainties in the process of proposing PFOA and the longer chained PFCAs as PBTs or vPvBs. As this is a general issue for all field based studies, a general discussion has been included in chapter 3.3.2.5. for the sake of readability. Taken each study singly would presumably not support the B-assessment. Overall, the assessment of B includes 12 field studies presenting various BMFs and TMFs from which all BMFs and TMFs including air breathing animals as top predators are above 1 and give evidence for biomagnification and trophic magnification. BMF and TMF values have been compared on a whole-body basis in chapter 3.3.4 (the summary of the bioaccumulation chapter) and chapter 6.2 (PBT assessment), as well as in the main SVHC identification. The study conducted by Vestergreen et al is an exception. Unlike the other field studies there is no uncertainty concerning opportunistic feeding as this study has a clear defined diet. The study does not provide data on a whole body basis. However, we think it is important to note that the results of this study indicate that long-chain PFCAs have a relatively high potential for transfer to milk and beef from the diet of dairy cows.

9. Houde at al.: A Klimisch score of three was given for this study, due to a probable point source (WWTP) and non-steady state deriving from this and the mentioned standard errors exceeding both TMF values. Some text was added in the paragraph: “PFNA was analyzed in plasma, liver, lung, kidney, heart, thymus, thyroid and muscle of two freshly dead dolphins and afterwards a whole body burden was calculated. The extrapolation of tissue specific concentrations to whole body burdens is based on the total body weight, the organ weights and the blood volumes.”

10. See our comments under point 4.

11. Kelly et al: Yes, there were multiple tissue samples. A pharmacokinetic model for marine mammals was used including growth; uptake from food, milk, and air; disposition of the chemical among arterial and venous blood, liver, muscle, blubber, and rapidly perfused tissues; and losses by metabolism, release in exhaled air, and by egestion. (Hickkie et al 1999). The basis for the model development were PCBs. Because PFCAs are primarily retained in protein-rich compartments (blood and liver), organism- and compartment-specific protein turnover rates may influence the toxicokinetics of these compounds. Tissue samples of sea ducks and marine mammals, including stomach contents, liver, muscle, blubber and/or milk, were collected. Wet weight PFA concentrations were expressed on a protein weight basis (ng·g-1 protein wt), using previously reported total protein content (PTOTAL) values of biological tissues/fluids of fish, birds and mammals. PTOTAL values of 2% for macroalgae, 25% for muscle,
25% for bird and mammalian liver tissue (25%), 7% for beluga blood and 11% for beluga milk were used. Uncertainties may occur due to interindividual differences (as for lipid normalization).
Eider duck and ringed duck were also part of the analyzed food web-they have been included in the table 8.

12. Xu et al: two egret bird species (Egrets and Night Herons) as prey animals were collected from Taihu Lake as indicated in the text (one animal for each species). In the case of PFNA there were no non-detects, concentrations in different organism have been included in the text.

13. See our comments under point 8.

14. For the comment on whole body estimation see our responses on Kelly et al., Houde et al. and Müller et al.

15-17. Rich et al. and Zhao et al.: a text has been added to explain the difference between BAF and BSAF.
Steady state was reached in both studies. A comparison to the other PFCAs has been added.

18. Müller et al.: As variations in concentrations in remote regions are expected to be low, the influence of sample from a different year is expected to be low, as well. Whole body concentrations were calculated for each individual caribou and wolf based on the concentration in the specific tissue and the mass fraction of this tissue. This is described in the study description. The number of tissue samples represent different number of animals for wolf and caribou. A discussion about the time trends of PFNA in remote regions has been included in chapter 3.3.4. Several studies on time trends are considered. Considering the time laps of the sampling years and comparing these with the time trends reported for PFNA, the variation due to sampling in different years is probably less pronounced than the variation between individual animals. As discussed in chapter 3.3.4 it is very difficult to quantify the uncertainties of whole body estimations. A discussion of the uncertainties concerning whole body burden estimates has been included. Details to the concentrations in the tissues have been included. Concentration for individual samples and sample years are, however, not given in the paper.

19. See our comments under point 4.	
		-		
4560
2015/10/15	FluoroCouncil,
Industry or trade association,
United States	-	Thank you for your comments and information. Table 13 has been slightly amended.	
		Attachment: 

Specific comments on the justification
Number / Date	Submitted by (name, submitter type, country)	Comment	Response	
4504
2015/10/12	Norway,
Member State	The Norwegian CA supports that Perfluorononan-1-oic acid (2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9-heptadecafluorononanoic acid and its sodium and ammonium salts should be identified as substances of very high concern because of PBT and Rep.1B, and should be included in the Candidate List.

We share the opinion that PFNA meets the criterion for bioaccumulating according to REACH Annex XIII.	Thank you for your support.	
4525
2015/10/14	Finland,
Member State	Perfluorononan-1-oic acid (PFNA) (EC 206-801-3) and its sodium and ammonium salts

The Finnish CA supports the proposal to identify PFNA and its sodium and ammonium salts as a PBT substance according to article 57(e) of the REACH regulation.

A weight-of-evidence determination according to the provisions of Annex XIII of REACH has been used to identify the substance as PBT. The conclusion on P is based on the stabile structure of highly fluorinated carbon chains that are not expected to undergo abiotic or biotic degradation under relevant environmental conditions, and read across to other similar substances (PFOA and C11-C14-PFCAs).

Although the numerical criteria of the REACH regulation for the B criterion are not applicable to PFNA, other information relevant for the B assessment (Annex XIII section 3.2.2.) shows that the B criterion is fulfilled. This information includes monitoring data, elimination half-lives from humans and other mammals, field data on bioaccumulation and trophic magnification in certain food webs in the environment and is in line with the expected regular pattern of fate properties of the already assessed PFOA and C11-C14-PFCAs.

The conclusion on T is based on the Committee for Risk Assessment (RAC) opinion that PFNA and its sodium and ammonium salts meet the criteria for classification as toxic for reproduction Repr. 1B, H360Df (“May damage the unborn child. Suspected of damaging fertility”). The Finnish CA agrees that the adopted opinion of RAC suggesting harmonised classification as Repr. 1B; H360Df is sufficient to fulfill the T criterion.

Based on the information available, it seems justified to conclude that these substances fulfil the PBT- criteria in Annex XIII to the Regulation.

In addition, the substance meets the criteria of Article 57(c) of REACH regulation based on the Committee for Risk Assessment (RAC) opinion. At RAC-30 the RAC adopted an opinion that PFNA and its sodium and ammonium salts meet the criteria for classification as toxic for reproduction Repr. 1B, H360Df (“May damage the unborn child. Suspected of damaging fertility”). The Finnish CA agrees that the adopted opinion of RAC suggesting harmonised classification as Repr. 1B; H360Df is sufficient to fulfill the criteria set out in Article 57 (c).

The Finnish CA notes that a Risk Management Option Analysis (RMOA) Conclusion Document on PFNA has been published on the ECHA website.  In the RMOA it is stated that “Although PFNA does not fulfill the relevancy criteria according to the SVHC Roadmap 2020 (no full registration yet), the identification of PFNA as a PBT substance and also as a possible replacement for PFOA are reasons for inclusion in the candidate list. Furthermore, an inclusion of PFNA in the candidate list would clearly establish that the substance has PBT properties and should therefore be substituted wherever possible.” The Finnish CA considers the reasons given in the RMOA for inclusion in the candidate list well justified.

The Finnish CA considers that after inclusion of the substance in the candidate list (for eventual inclusion in the Annex XIV) it can still be further explored which risk management measures would be the most appropriate.	Thank you for your support.	
		-		
4541
2015/10/15	United Kingdom,
Member State	We thank Germany for their proposal and have the following comments;

Toxic for Reproduction (Art 57c)
We agree that PFNA, PFN-A and PFN-S meet the criteria according to Article 57(c).

PBT (Art 57d)

We agree that the substances can be considered to meet the PBT criteria. The reasons for meeting P and T are clear. However, we think the basis for meeting the B criteria is principally a category one, rather than the specific bioaccumulation data for PFNA, which are quite weak. The homologues either side of PFNA (namely PFOA and the C11-C14 analogues) have been identified as being (v)PBT or vPvB, so it is logical to conclude that PFNA is at least B.

The BMF and TMF data for PFNA listed under conclusion points 2 and 3 appear in many cases to be equivocal due to the uncertainties in either the methodology or the calculations in the studies. We think the values of several should not be included in the SVHC ID document (i.e. only discussed in the supporting document). The uncertainty in the studies also needs to be acknowledged under points 2 and 3. This is discussed in the support document but not the ID document.

Under conclusion point 4, we think a specific analogy with the human half-life of PFOA would be useful.

Overall we think the specific identification for “B” should make a stronger case based on the category approach, which is not included under the conclusion for bioaccumulation.

We disagree with the inclusion of the text that PFNA may potentially fulfil the vB criteria. However, an assessment confirming this assumption was not carried out in the context of this PBT assessment. This makes the conclusion ambiguous: vPvB is not being proposed and so such a statement should not be made. For the avoidance of doubt, we do not agree that PFNA potentially meets the vB criteria based on the evidence presented in the support document.	

Thank you for your support.

Slight changes have been made in the first part of the support document.

Text has been amended.	
		-		
4550
2015/10/15	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust supports inclusion of Perfluorononanoic acid (PFNA) and its sodium  and ammonium salts in the REACH candidate list Article 57(c) based on the RAC opinion  that PFNA and its sodium and ammonium salts meets the criteria for classification as toxic for reproduction Repr. 1B, H360Df (“May damage the unborn child”).	Thank you for your support.

4556
2015/10/15	ChemSec,
International NGO,
Sweden	ChemSec supports the identification of PFNA as an SVHC based on the evidence laid out in the dossier. The substance has been acknowledged by RAC to be reprotoxic, while both experimental, measured and field data proves the substance to be persistent and bioackumulative.	Thank you for your support.
	
4560
2015/10/15	FluoroCouncil,
Industry or trade association,
United States	p. 46, Table 133

To Whom It May Concern -

The Global Industry Council for FluoroTechnology (FluoroCouncil) appreciates this opportunity to provide comments on the “Annex XV SVHC report published in the context of SVHC identification in accordance with REACH Article 59” published by the European Chemicals Agency for public comment.

The FluoroCouncil is a global membership organization representing the world’s leading manufacturers of fluoropolymers, fluorotelomers, and other fluorinated surfactants and surface property modification agents.  The FluoroCouncil has a fundamental commitment to product stewardship and, as part of its mission, addresses science and public policy issues related to FluoroTechnology, including PFOA and related long-chain substances.

While FluoroCouncil generally supports the SVHC designation for PNFA from a regulatory and scientific point of view, we would emphasize that making such a designation based on the quality of scientific references and limited data set currently included in the report is not justified and should not be the basis for this or future substance evaluations.

We are also concerned that there is a continuing claim that there is no data in the public domain.  This is not true and our supporting comments help to clarify this point.

Finally, some of the supporting information in the report also mixes a broad range of substances.  It is important to make a clear distinction throughout the report.

To enhance the accuracy and quality of the report FluoroCouncil recommends:

1. Updating Table 133 (page 46).  “Table 133 (page 46) summarizes published data on half-lives of PFCAs in humans and other species.  FluoroCouncil suggests to upgrade and augment the table to:
• include data from additional scientific references for some species as outlined in the table provided below, including information on the model used and elimination phase considered (citations included)
• include references and findings from human biomonitoring data in column “PFCA” (References “a” through “e”)
• provide the “Mean” and “Geometric Mean (GM)” for human data
• split the human data into main columns “Occupational Workers” and “General Population” with two subdivisions each.
• provide further details on the basis of values listed.  For example for “General Population” data, “Values shown are estimates based on either two longitudinal blood samples or lack of detection in general population” or “Values shown are upper bound (i.e. conservative) estimates calculated from single blood and urine samples”.  This has been highlighted by different color shading in the table below.”

2. Making a clear distinction in tables, supporting data, and the overall report between long-chain and short-chain substances.  This should include a separation of the short-chain substances currently in Table 133 into a separate table, as well as making appropriate distinctions in other areas of the report.	

Thank you for supporting our conclusion on the PBT properties of PFNA. The data supporting this conclusion cover both data on the substance itself, i.e. PFNA, and data for the shorter (PFOA) and longer (PFDA) homologues. We have tried to make that clear in the report.

Table 13 (133 is a printing error) has been slightly revised taking your comments into account. We do not agree that the short-chain substances should be in a separate table. The aim of this table is to visualize the increased half-lives  with number of carbons and also the large species differencies.	
		Attachment: 
		
4566
2015/10/15	Health and Environment Alliance (HEAL),
International NGO,
Belgium	We support the nomination of PFNA to the Candidate List	Thank you for this support.	

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, submitter type, country)	Comment	Response	
4560
2015/10/15	FluoroCouncil,
Industry or trade association,
United States	-	Thank you for your comments and information. Table 13 has been slightly amended	
		Attachment: 
		
4561
2015/10/15	Netherlands,
Member State	NL supports the proposal to include Perfluorononanoic acid and its sodium and ammonium salts in the candidate list of SVHC in accordance with Article 57(c) and (d) of Regulation (EC) 1907/2006 (REACH) due to its reprotoxic effects as well as its PBT properties, but still wants to stress that a category approach by including all long-chain perfluorocompounds seems to be a suitable way forward to prevent the potential replacement of PFNA by other PFCAs.	Thank you for your support and also for the comment regarding further risk reduction measures.