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

Disclaimer: Comments provided during the 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. 

Substance name: Perfluoroheptanoic acid and its salts
CAS number: -
EC number: -

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 57c);PBT (Article 57d);vPvB (Article 57e);Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health);Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)

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	
5623
2022/10/12	Norway,
Member State	The Norwegian CA supports that perfluoroheptanoic acid and its salts should be identified as substances of very high concern and should be included in the Candidate List. We agree with the dossier submitter that with the fulfilment of the criteria for classification as Repr. 1B H360D, perfluoroheptanoic acid and its salts meet the criteria for identification as a SVHC in accordance with Article 57 (c) of REACH. We also agree with the dossier submitter that with the fulfilment of the criteria for classification as STOT-RE 1 H372 (liver), perfluoroheptanoic acid and its salts fulfil the T-criterion according to Annex XIII of the REACH Regulation.
We support that perfluoroheptanoic acid and its salts fulfil the SVHC criteria in REACH Article 57 d) persistent, bioaccumulative and toxic (PBT) and Article 57 (e) very persistent and very bioaccumulative (vPvB). We agree with the weight-of-evidence approach the dossier submitter has  used to identify the substances as PBT and vPvB.
Furthermore, we fully support this proposal to identify perfluoroheptanoic acid and its salts as substances of equivalent level of concern to Art. 57 a to e. The equivalent level of concern has been clearly described and follows a case-by-case approach using the weight of evidence evaluation. The Norwegian CA strongly supports this case-by-case approach demonstrating ELoC.

5628
2022/10/13	Daikin Industries, Ltd.,
Company,
Japan	In Daikin’s view,
(page 1 through 2)
1. Bioaccumulation of PFHpA and its salts is scientifically not proven.
One of the reasons is that half-life is not enough as evidence for B-assessment.
Also, half-life estimates based on urinary excretion are less certain.
When the B/vB is scientifically not justified, criteria of PBT/vPvB is not considered to be fulfilled.
(page 2 through 3)
2. SVHC listing of PFHpA and its salts because of ELoC to PFOA is not appropriate due to lack of individual assessment.
(page 3)
3. There is no sufficient necessity of listing PFHpA and its salts to SVHC list due to lack of information on application/uses and REACH registration.		
		Attachment: 5628_Daikins opinion on PFHpA SVHC listing proposal (20221013).pdf
		
5631
2022/10/13	Health and Environment Alliance (HEAL),
International NGO,
Belgium			
		Attachment: 5631_HEAL Comments-Perfluoroheptanoic acid and its salts.pdf
		
5675
2022/10/17	ANSES,
National Authority,
France	Page 57: Please ad a reference to the following statement : These half-lives exceed the range of guiding values for biomagnificating substances in humans that are considered to be in the range of 30 to at most 70 days.		
				
5721
2022/10/17	3M,
Company,
Belgium			
		Attachment: 5721_3M comments on SVHC proposal for pFHPA.pdf

Specific comments on the justification
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5628
2022/10/13	Daikin Industries, Ltd.,
Company,
Japan			
		See the corresponding embedded attachment in table 1 of Part I: 5628_Daikins opinion on PFHpA SVHC listing proposal (20221013).pdf		
5631
2022/10/13	Health and Environment Alliance (HEAL),
International NGO,
Belgium	The Health and Environment Alliance (HEAL) thanks the Dutch Competent Authority for its proposal and fully supports the identification of PFHpA and its salts as a substance of very high concern (SVHC) due to its reprotoxic properties (article 57(c)), its PBT properties (Article 57(d)), its vPvB properties (Article 57(e)), and its endocrine disrupting properties relevant for human health and the environment (article 57(f)). Our detailed comments can be found in the attached document.
		
		See the corresponding embedded attachment in table 1 of Part I: 5631_HEAL Comments-Perfluoroheptanoic acid and its salts.pdf		
5635
2022/10/14	Germany,
Member State	
The German CA supports the identification of perfluoroheptanoic acid and its salts as substances of very high concern (SVHC). The substances are proposed to be identified meeting several criteria according Article 57 (c), (d), (e) and (f) of Regulation (EC) No 1907/2006 (REACH) due to its respective hazardous properties.

4.1.1 Non-human information
1st paragraph, 2nd sentence: Toxicokinetics data are available for mice. Please see Fujii et al., 2015 and supplemental material. DOI: 10.1539/joh.14-0136-OA.
Generally, the term PFASs in this section probably rather refers to PFCAs or PFAAs than to all PFASs. In general, we suggest a list of PFASs that were investigated in each of the described studies.

Rats
It is unclear, whether Kudo et al. 2001 also measured PFHpA.

4.1.2 Human information
Reference missing within study description of Freberg et al., 2010.

5.2.2 Endocrine Disruption
The reference for the study following OECD TG 422 is missing.

5649
2022/10/14	Sweden,
Member State	The Swedish CA thank the Netherlands for this proposal and agrees that PFHpA and its salts meets the criteria according to Article 57(c), 57(d) and 57(f) in REACH and is thus eligible for identification as a substance of very high concern.
However, as regards the criteria of Article 57 (e) we are not convinced that PFHpA and its salts are vB. The reason for this is that such a conclusion would be inconsistent with the conclusions drawn when PFOA was identified as a substance meeting the B-criteria of Article 57 (d). The weight of evidence approach used for the B-criteria for PFOA includes among other things also half-lives in humans in the range from 2 – 4 years. As the argument of half-lives in humans and other species also is used for PFHpA, but the half-lives for PFHpA in all studied species always are shorter than those of PFOA, we find the conclusion that the half-lives of PFHpA supports vB not being consistent with the conclusions previously drawn for PFOA.		
				
5670
2022/10/17	Finland,
Member State	We thank the Netherlands for this proposal. We would like to present the following comments on the Annex XV report:

page 8: “This value fits well between values derived for PFOA (236) and PFHxA (4.1).”

Comment: Please specify in the text the reasons why these substances are referred to (e.g. the closest structural analogues differing only by one carbon in chain length?) and indicate the parameter for the values 236 and 4.1.

page 12: “The observed probable serious effects for human health and the environment are reproductive toxicity and yet unknown environmental effects.”

Comment: Please clarify the sentence (observed effects cannot include unknown effects).

page 52: “Indeed, the half-lives exceed the range of guiding values for biomagnification of substances in humans, which are proposed to be in the range of 30 (B) to at most 70 (vB) days”

Comment: A source for these guiding values is not presented in the document and at least we are not aware where these values are proposed. Is this based on published information? We propose to include more information regarding how these values are derived, considering that there are no criteria for elimination half-lives in REACH regulation or guidance to be used for concluding on the B and vB.

5675
2022/10/17	ANSES,
National Authority,
France	
ANSES supports the proposal of identification of Perfluoroheptanoic acid and its salts (PFHpA and its salts) as SVHC according to articles 57c, 57d, 57e, 57f.

• Based on a weight of evidence approach, the Substances fulfil the criteria for PBT/vPvB substances according to annex XIII or the REACH Regulation.

PFHpA and its salts are expected to undergo no or extremy limited degradation in the environment, this is because of the stability of the C-F bond and the read-across with substances such as PFHxA, HFPO-DA, PFOA, PFNA, PFDA and C11-C14 PFCAs, which their persistence/very persistence properties have already been confirmed by the Member State Committee. Monitoring data of PFHpA, especially in remote areas such as the Arctic (in air, snow, fresh- and marine water (including sediments) and soil) and the Antarctic (snow), locations that are far away from point sources, support the persistence of the substance. Considering the available information, PFHpA and its salts fulfil the P/vP criteria. The Substances exhibit a low bioaccumulation potential for aquatic organisms. However, in air-breathing organisms such as humans and pigs, PFHpA is very bioaccumulative.  The geometric mean elimination half-life for pigs is 74 days, resulting to a biomagnification factor of 2.7, therefore PFHpA and its salts have the potential to biomagnify in pigs. In humans, the highest elimination half-live value reported is 3.3 years (average elimination half-life is at least 76 days). Taking into account the overall information, especially in humans and pigs, the Substances fulfill the vB criterion.  Regarding toxicity, PFHpA has an harmonized classification for reproduction category 1B and STOT RE 1. Therefore, PFHpA and its salts meet the toxicity criterion (T) in accordance with Annex XIII,of the REACH Regulation.

Equivalent level of concern (Article 57f)

PFHpA and its salts exhibit very low log Koc values of 1.63-1.7, which implies a very low adsorption potential, thus a high mobility capacity of the substance in the environment. The detection of PFHpA or its salts in tap water, bottled drinking water and groundwater supports the conclusion that PFHpA and its salts are mobile in water. The removal of PFHpA or its salts from the aquatic environment and from drinking water is difficult as the available information shows that current conventional water purification techniques do not readily remove the substance; this also explain the occurrence of the substance in drinking water in Europe. Humans are exposed to PFHpA or its salts via the environment directly and continuously during their whole life, which is critical because the substance is classified as reproduction category 1B (H360D: ‘May damage the unborn child’).
According to modelling data, PFHpA and its salts also exhibit a high potential for long-range transport in the environment, which takes place via the atmosphere and oceanic currents, this conclusion is supported by the occurrence of PFHpA on polar regions as well as a high altitude remote areas in the European Alps.
On this basis, ANSES agrees that several concerns are caused by these intrinsic properties of PFHpA and its salts justifying SVHC identification under articles 57c, 57d, 57e, 57f.

		
				
5688
2022/10/17	CHEM Trust Europe,
International NGO,
Germany	CHEM Trust supports the inclusion of perfluoroheptanoic acid and its salts in the REACH candidate list because of its reproductive toxicity (article 57(c)) as well as due to its PBT and vPvB properties (articles 57 (d) and (e). The dossier makes a convincing case based on a weight-of-evidence determination according to the provisions of Annex XIII, bringing together the evidence for a combination of these harmful properties. The very high persistence together with low adsorption potential and high mobility imply a very high potential for increasing pollution stock in the environment and for irreversible and increasing exposure of both wildlife and humans exposed via the environment. Also, their low adsorption potential and high water solubility mean that PFHpA and its salts are highly bioavailable for uptake via water. The additional concern due to the substances´ high mobility in water, the potential for being transported in the water phase over long distances, difficulty of remediation and water purification is an important justification for an equivalent level of concern identification, i.e. including it also under article 57 (f).		
				
5700
2022/10/17	ChemSec,
International NGO,
Sweden	ChemSec supports the addition of these substances to the SIN List based on the classification as toxic for reproduction, category 1b AND the being a vPvB AND a PMT as is proven in the dossier.		
				
5721
2022/10/17	3M,
Company,
Belgium	3M disagrees with the conclusions on the identification of the Substance as i) PBT and vPvB under Article 57 (d) and (e) and ii) substance of equivalent level of concern to the substances listed in Article 57 points (a) to (e) under Article 57 (f), for many reasons listed in our more detailed comments (please see in pdf attached).		
		See the corresponding embedded attachment in table 1 of Part I: 5721_3M comments on SVHC proposal for pFHPA.pdf		
5730
2022/10/17	European Environmental Bureau,
International NGO,
Belgium	The EEB supports the proposal submitted by The Netherlands to identify Perfluoroheptanoic acid (PFHpA) and its salts as Substances of Very High Concern in accordance with REACH Articles 57 (c), (d), (e) and (f), due to their classification as reprotox cat 1B, and PBT, vPvB, PMT and vPvM properties. We note the detection of PFHpA or its salts in groundwater, tap water and bottled water. The substance led to widespread contamination across the globe, ranging from the Arctic to the Antarctic. The widespread pollution of the environment by PFHpA and its salts is irreversible and leads to lifelong exposure of wildlife and humans, including future generations through nutrition and drinking water.

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	
5628
2022/10/13	Daikin Industries, Ltd.,
Company,
Japan			
		See the corresponding embedded attachment in table 1 of Part I: 5628_Daikins opinion on PFHpA SVHC listing proposal (20221013).pdf		
5631
2022/10/13	Health and Environment Alliance (HEAL),
International NGO,
Belgium			
		See the corresponding embedded attachment in table 1 of Part I: 5631_HEAL Comments-Perfluoroheptanoic acid and its salts.pdf		
5721
2022/10/17	3M,
Company,
Belgium			
		See the corresponding embedded attachment in table 1 of Part I: 5721_3M comments on SVHC proposal for pFHPA.pdf