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

Substance name: Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts
CAS number: 335-76-2, 3830-45-3, 3108-42-7
EC number: 206-400-3, -, 221-470-5

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. 

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	Responses	
4759
2016/10/21	Norway,
Member State	-	Thank you for the information. See response 4759 in the next table below.	
		Attachment: 4759_Perfluorinated alkylated substances,etc-Screening 2013.pdf

4789
2016/10/21	Health & Environment Alliance (HEAL),
International NGO,
Belgium	HEAL supports the adoption of PFDA as a substance of very high concern.  It has been on the SIN List since 2014.	Thank you for your support.	
Specific comments on the justification

Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
4622
2016/10/17	ANSES,
Academic institution,
France	- Identification according to Article 57(c) – reproductive toxicity

Classification of PFDA and its ammonium and sodium salts as Repr. 1B – H360Df  is recommended by the RAC in its opinions of 4 December 2015 and subject to their adoption in an ATP of the CLP, ANSES agrees that PFDA and its two salts meet the criteria of a SVHC in accordance to article 57 (c) of the REACH regulation.

- Identification according to Article 57(d) – PBT

The assessment of PBT properties was conducted from a weight of evidence approach according to the provisions of Annex XIII of REACH. For this approach, MS considered all available information such as the results of standardized tests, information from category approach (grouping, read-across), QSARS, modelling data and monitoring information.
In the document, the abbreviation PFDA refers to the acid (PFDA) and its ammonium (PFD-A) and sodium (PFD-S) salts.

Persistence
No degradation studies under relevant environmental conditions are available for PFDA, study results regarding structurally similar substances from the same chemical group (PFOA) to evaluate the degradation of PFDA are considered relevant.

- No studies on hydrolysis of PFDA are available, but considering the read-across with PFOA (C8-PFCA) which exhibits a hydrolytic half-life greater than 97 years in water, it is concluded that PFDA is hydrolytically stable in the environment. Furthermore, PFOA does not undergo direct photodegradation in natural waters and the estimated half-life for indirect photolysis is 349 days.
- Concerning biodegradation, there are no studies available for PFDA for screening tests, but based on information of PFOA, PFDA is considered as not ready biodegradable.

Considering the available knowledge (information well documented by several studies) on the high stability of the C-F bonds and using the read–across approach with PFOA, PFDA is considered as vP (very persistent), the substance resists to abiotic and biotic degradation.

Bioaccumulation
According to data from different studies with PFDA, there is enough evidence that supports that PFDA is bioaccumulable. The assessment was based not only on BCF data  but also using other relevant information such as the bioaccumulation potential measured  in elevated levels in biota,  biomagnification in the food chain, analysis of human body fluids or tissues and toxicokinetic behaviour of the substance.

To summarize:
- PFDA accumulates in humans. There is strong evidence that the substance is present in human blood of the general population and has also been detected in human brain, lungs and kidney. Humans have very long elimination half-lives of PFDA, estimations indicates an average elimination half-lives in general populations between 4.0 and 7.1 years, depending on sex and age.

- There is evidence that PFDA preferentially bioaccumulate in air-breathing mammals, included endangered species (dauphins, polar bear and beluga whale) and humans. The BFMs (biomagnification factor) reported a range from 2.4 to 8.8 based on estimated whole body values in marine food web, and for trophic magnification (TMFs) the studies shows values ranged from 2.1 to 12.1 referring also to whole body measurements or estimated whole body values in marine food web.

- Based on BCF values, bioaccumulation in fish cannot be excluded, the report shows and highlights that PFDA does not accumulate in lipid but rather binds to protein and membrane phospholips. Thus, BCF values calculated from whole body or carcass is less relevant for the analysis. Based on BCF value in blood of rainbow trout (2700+-350), the substance can be considered as bioaccumulative (BCF>2000).

- The bioaccumulation data on PFDA are in line with the expected pattern of fate properties of already assessed substances PFOA, PFNA and C11-C14 PFCAs.

Toxicity
According to RAC opinion the substances meet criteria for classification as toxic for reproduction in accordance with article 57(c) or REACH regulation.

Taking into account all these information, ANSES supports that PFDAs fulfil the PBT criteria that is an SVHC  according to REACH article 57(d).	Thank you for your support.	
		-		
4631
2016/10/19	United Kingdom,
Member State	Overall
We agree that there is sufficient evidence that PFDA meets the PBT criteria, but we disagree with the dossier submitter about the main evidence for “B” that should be used.

We consider that the bulk of the “B” evidence presented in the dossier is often equivocal, with the field data in particular frequently being of variable quality. While deficiencies are noted in some cases, these concerns are then either set aside, or not considered when the conclusions are drawn.

The risk management of these substances is being prepared on a category basis, and we consider the PBT data should more clearly be assessed on a category basis. Since the immediate lower and higher homologues of PFDA have already been agreed to be “B”, this provides sufficient evidence that PFDA is B.

Specific points:
P14: given the substance is surface active, how reliable is the water solubility, or what does this represent (critical micelle concentration, etc?)

P14: please add a footnote to explain a little about the Cosmotherm QSAR used to predict log Kow.

P20-21: the studies cited (Loi et al, 2011; Labadie & Chevreuil, 2011 and Furdui et al 2007) all have low numbers of organism samples. Please acknowledge this and discuss the uncertainty associated with this in the text.

P21: Furdui et al: please comment in the text on the reliability of a BAF calculated from the average fish concentration and the average lake water concentration

P23: Higgins et al 2007: please mention the number of animals and replicates in the text. We think lipid normalisation of these data is debatable if the substance is not generally accumulating in lipid. For example, why normalise for lipid but not organic carbon here? We appreciate the issue is not straightforward (as indicated in the text). A further issue is whether invertebrates such as Lumbriculus have fewer obvious protein hot spots for substance accumulation (compared to a vertebrate liver, for example)?

P25: please split the text so that laboratory and field BMF data are considered separately.

P25: Martin et al 2003: it is odd to have an assimilation efficiency exceeding 100%, please can you explain/comment on this in the text. Is leaching from spiked food of what is a surfactant a problem?

P25: Martin et al 2003: if the above comment for the study can satisfactorily be addressed, we think the study should be considered in more detail. What body burden was achieved? The k2 value of 0.07 d-1 suggests depuration is slow, and could provide important supporting information for the conclusion of “B”. We note Rainbow Trout were used – are the results growth corrected, which could be important for this fish species.

General comment on BMF and TMF data: None of these appear to be of high quality, and most appear to be equivocal. This is due to, inter alia, the small sample size, sampling trophic levels in different years and the uncertainty for extrapolating accumulation factors for organs to whole body.

P32: on an earlier page (p29) some of the uncertainties with field trophic magnification data are discussed. Please consider these concerns in the conclusion paragraph – are the available TMF data unequivocal?

P36: We think the trend in bioaccumulation in the category needs to be considered in more detail in this section. The C12-C14 PFAs were concluded as vB based on fish BCF values above 5000. The C11 PFA has a fish BCF >2000. This suggests hydrophobicity does become more important with increasing chain length despite the preference for accumulation in protein-rich tissue/organs. We think it would be helpful to include table A.3 in this conclusion section. To us the category argument is stronger than the field bioaccumulation data.

P39-45. The RAC opinion (for the human health classification of the substance) notes the findings of Benninghof et al. 2012. This is not used for the carcinogenicity classification, but does suggest possible effects in the liver of Rainbow Trout (for example liver disease). Please consider whether this study provides any supporting information for the “B” aspect of the dossier, for example demonstrating why there is concern for accumulation of PFDA in fish liver.	Thank you for your suggestion. We included some text in the conclusion section 3.3.4.

We did slight modifications in the summary and section 6.2.1.2, and additions to section 3.3.4 to further point out the category argument (see also comment below). 

p.14 Text has been added that the value represents saturated solution.

p.14 A reference to the COSMOtherm model has been added. 

p.20-21 Some text concerning the uncertainties was added for the study of Loi et al.

In the summery of the Labadie & Chevreuil-study uncertainties of the study have been addressed already. But indeed in regard of the observed inter-individual variations a larger sample size would have led to a more robust BAF. Some text was added.

However, in our opinion a sample size of 10 fish per lake as in the Furdui study is sufficient.

p.21 According to the materials  and methods section in the paper each sample was treated and measured  individually. BAFS are given for each lake and the values are similar. We added the BAFS values for each lake. The individual BAFs are not given in the paper. One may however conclude from the measured concentrations and there standard error (smaller than±20%, with the exception of lake Michigan) that the variability of the individual BAFs based on these data are acceptable. For instance the OECD305 guideline request that concentration of the test substance in the chambers is maintained within ± 20% .

p.23 In the paper of Higgins et al. protein hotspots and thus cause for accumulation are not discussed. However the paper does report a very slow elimination. The authors suggest that this is due to a lack of metabolic transformation and/or conjugation assisted excretion. The number of replicates is not given in the paper. During the uptake phase 11 samples were taken over a time course of 56 days and six samples during a depuration phase of 40 days. As standard deviation is given at least three replicates per time point must have been taken.

p.25 Martin et al 2003b: Yes the results are growth corrected. Some text has been added. In the other paper Martin at al (2003) the theory that PFCAs enter into enterohepatic recirculation in fish is discussed which would explain the high assimilation rate.

We added a paragraph in the conclusion chapter which discusses the uncertainties of field studies.

p.36 In our view all three figures in the attachment would make a strong point for the category approach (we therefore added them in the attachment). For the sake of readability we suggest to leave the figures there.

p.39-45 A text considering hepatoxicity is already included in chapter 3.3.2.4. We added the Benninghof study.	
		-		
4709
2016/10/20	Netherlands,
Member State	NL supports the proposal to include PFDA 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 their reprotoxic effects as well as their PBT properties. However, according to expert judgement also 57 (e) should be flagged in view of the vPvB properties.	Thank you for your support to the proposal to identify PFDA and its ammonium and sodium salts as SVHC in accordance to Article 57(c) and 57(d) of the REACH regulation due to their reprotoxic and PBT properties. As regards to the potential to meet the criteria of Article 57(e) (vPvB), we do not consider it to be obvious that PFDA and its salts can be identified as very bioaccumulative (vB). Furthermore, the PBT identification according to Article 57(d) is also considered to be enough from a risk management point of view. Adding identification as vPvB would not change the risk management measures.	
4716
2016/10/20	ChemSec,
International NGO,
Sweden	ChemSec supports the identification of PFDA as a Substance of Very High Concern. The substance is agreed by RAC to be toxic to reproduction and it is also a PBT substance. The dossier presents clear evidence of the PBT properties. When we added this substance to the SIN List in 2014 we also used the additional below references to strengthen the case of it being a PBT substance:

Dai, Z., X. Xia, et al. (2013). "Bioaccumulation and uptake routes of perfluoroalkyl acids in Daphnia magna." Chemosphere 90(5): 1589-1596.

Falandysz, J., P. Rostkowski, et al. (2012). "Determination of perfluorinated alkylated substances in sediments and sediment core from the Gulf of Gdańsk, Baltic Sea." Journal of Environmental Science and Health, Part A 47(3): 428-434.

Fernández-Sanjuan, M., J. Meyer, et al. (2010). "Screening of perfluorinated chemicals (PFCs) in various aquatic organisms." Analytical and Bioanalytical Chemistry 398(3): 1447-1456.

Naile, J. E., J. S. Khim, et al. (2013). "Distributions and bioconcentration characteristics of perfluorinated compounds in environmental samples collected from the west coast of Korea." Chemosphere 90(2): 387-394.	Thank you for your support. We included the studies of Dai et al. Unfortunatly two of the suggested papers either do not have data for PFDA or do not include Bioaccumulation metrics but concentrations of PFCAs. The focus of study of Naile et al. is rather the status and trends of contaminants in the Yellow Sea than a bioaccumulation study. The determination of BCFs (or better BAFs as this is a field study) seems to be more of a byproduct, and the results come with some uncertainties such as the pooling of different species from various locations with a different degree of contamination and possible point sources.	
		-		
4759
2016/10/21	Norway,
Member State	We support that PFDA should be identified as a SVHC because of its PBT properties. The data on persistence and toxicity is indisputable. Furthermore, we can supply some more data supporting the identification of PFDA as a bioaccumulating substance. Arctic screening results involving, amongst others, polar bear, ringed seal and polar cod indicates that PFDA magnifies in the marine Arctic food web with a TMF> 1. Similar results were found for marine ecosystems from the Norwegian mainland (Harju et al. 2013).
Reference:
Harju, M., Herzke, D., Kaasa, H. (2013). Perfluorinated alkylated substances (PFAS), brominated flame retardants (BFR) and chlorinated paraffins (CP) in the Norwegian environment – Screening 2013. Norwegian Institute for Air Research, NILU OR 31/2013	Thank you for your support. We see that your extensive study further supports that PFDA biomagnifies, but we believe that there is enough evidence in the dossier already to conclude that PFDA is bioaccumulative. 	
		Attachment is embedded in table 1 of Part I: 4759_Perfluorinated alkylated substances,etc-Screening 2013.pdf		
4762
2016/10/21	The Swedish Society for Nature Conservation,
National NGO,
Sweden	The Swedish Society for Nature Conservation supports the identification of PFDA as a Substance of Very High Concern.The widespread use and findings in biota worldwide of persistant PFASs is of great concern and should be urgently addressed. The substance PFDA is agreed by RAC to be toxic to reproduction and it is also a PBT substance. The dossier presents clear evidence of the PBT properties.	Thank you for your support.	
4783
2016/10/21	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust supports the proposal to include PFDA as a substance of equivalent concern in the REACH candidate list based on Article 57 d). The dossier convincingly draws together the evidence to show that PFDA meets the PBT properties as laid out in Annex III of REACH. The substance has not only been found in Baltic Sea sediments and aquatic organisms from many regions, but also in mammals including polar bears and whales. PFDA is present in human blood in the general population, which illustrates the urgent need for regulatory action on this reprotoxic compound.	Thank you for your support.	
4796
2016/11/01	Finland,
Member State	The Finnish CA supports the proposal to identify nonadecafluorodecanoic acid and its sodium and ammonium salts (later referred to as PFDA) as a SVHC substance according to REACH Regulation Article 57(c) and 57(d) of the REACH regulation.

Identification according to Article 57(c)

PFDA meets the criteria of Article 57(c) of REACH Regulation based on the harmonised classification Repr. 1B; H360Df (“May damage the unborn child. Suspected of damaging fertility”) which was accepted in the REACH Committee meeting in October 2016.

Identification according to Article 57(d)

A weight-of-evidence determination according to the provisions of Annex XIII of REACH has been used to identify the substance as PBT according to Article 57(d). 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 (C8, C9, C11-C14- perfluorinated carboxylic acids (PFCAs)).

Although the numerical criteria of the REACH Regulation for the B criterion are not applicable to PFDA, 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 C8, C9, C11-C14-PFCAs.

The conclusion on T is based on the harmonized classification Repr. 1B; H360Df (“May damage the unborn child. Suspected of damaging fertility”), which was accepted in the REACH committee meeting in October 2016. Thus the  T criterion is fulfilled.

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

Regarding persistence and bioaccumulation assessment, we have the following comments to the Annex XV report:

Editorial proposal to Chapter 3.1.2.1.1: Please consider changing “Nevertheless, these estimations can be assumed to be low because…“ to “ Nevertheless, these half-lifes can be assumed to underestimate the persistence because…”, if that is what is meant.

In addition, please consider to amend the Chapter 3.1.2.1.1 to take into account the following:

Lambert et al. (2011) uses another report (Rorije et al. 2011) as a source for the half-lives. It seems that the half-lives derived by Rorije et al. (2011) originate from BIOWIN 3 model. It should be noted that not all the molecular fragments of PFDA (CAS 335-76-2) are included ion BIOWIN 3 prediction. In particular, regarding the fluorinated part, the prediction only includes one trifluoromethyl group whereas the remaining part of the perfluorinated carbon chain is counted as eight units of “carbon with 4 single bonds & no hydrogens”. Considering that the perfluorinated carbon chain is expected to be very stable but not properly included in the model, this observation can support the conclusion that the estimated half-lifes can underestimate the persistence. In addition to the above-mentioned “Trifluoromethyl group [-CF3]”, the set of fragment coefficients included in BIOWIN 3 includes one fluorine-containing fragment (“Aromatic fluoride [-F]”), which, however, is not included in PFDA. We also note that the training set for BIOWIN 3 contains 200 compounds and, even though we have not explored how many of these compounds exactly include fluorine, it can be noteworthy that  “fluor” or “fluoro” is included only in the names of three compounds, none of which seem to include perfluorinated carbon chains.

The statement (occurring at least in in 3.1.2.1.1 and 3.1.3 and in other words also in 6.2.1.1) that the C-F bond is “..not subject to degradation by microorganisms occurring in the environment” could be rephrased e.g. to “..therefore expected to have a very low susceptibility to degradation by microorganisms occurring in the environment”, because fulfilment of P/vP criterion does not mean that the substance would not be at all degraded and in the long term some degradation can be possible (for example in one of the ready biodegradation tests 5-7% degradation was observed for PFOA and its ammonium salt).

Regarding 3.1.3 it is mentioned that “…does not undergo abiotic or biotic degradation at all under environmental conditions”. Please consider aligning this as mentioned above, e.g. “…is expected to undergo extremely limited abiotic or biotic degradation under environmental conditions.”

It is mentioned on p. 20 that liver samples from water birds were collected in Loi et al (2011). However, there are no results shown for these samples. Please include these results if available.

On page 31 (regarding Xu et. al. 2014) the sentence “Among the 2 analysed PFCAs (C8-C12) were detected in all biological samples” should be edited to clarify which PFCAs were studied and which PFCAs were detected in all biological samples.

Other observations

The Finnish CA notes that a Risk Management Option Analysis (RMOA) Conclusion Document on PFDA has been published on the ECHA website.  In the RMOA it is stated that “Although PFDA does not fulfill the relevancy criteria according to the SVHC Roadmap 2020 (no full registration yet), the identification of PFDA as a PBT substance and also as a possible replacement for PFOA are reasons for inclusion in the candidate list. Furthermore, an inclusion of PFDA 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 of PFDA 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.

Thank you for the comment regarding persistence assessment. We amended chapters 3.1.2.1.1, 3.1.3 and 6.2.1.1

On p.20 this is a general summary of the Loi study which is also described in the TMF chapter. However, BAFs for birds are not given. In order not to mislead the reader we deleted those parts which are not important for the BAF part.

p.31 The text was changed accordingly. All longer chained PFCAs were found in all biological samples.

	

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	Responses	
4759
2016/10/21	Norway,
Member State	Attachment is embedded in table 1 of Part I: 4759_Perfluorinated alkylated substances,etc-Screening 2013.pdf	Thank you for the information. See comment above.