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UNITEDNATIONS SC

UNEP/POPS/POPRC.13/INF/7

Stockholm Conventionon Persistent OrganicPollutants

Distr.: General27 July 2017

English only

Persistent Organic Pollutants Review CommitteeThirteenth meetingRome, 17–20 October 2017Item 5 (a) (ii) of the provisional agenda

Technical work: consideration of draft risk management evaluations: pentadecafluorooctanoic acid (CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and PFOA-related compounds

Comments and responses relating to the draft risk management evaluation on pentadecafluorooctanoic acid (CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and PFOA-related compounds

Note by the SecretariatAs referred to in the note by the Secretariat on a draft risk management evaluation on

pentadecafluorooctanoic acid (CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and PFOA-related compounds (UNEP/POPS/POPRC.13/3), the annex to the present note contains tables listing the comments and responses relating to the draft risk management evaluation on PFOA, its salts and PFOA-related compounds. The present note, including its annex, has not been formally edited.

Annex

UNEP/POPS/POPRC.13/1.

020817


Comments and responses relating to the draft risk management evaluation on pentadecafluorooctanoic acid (CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and PFOA-related compounds

1. Minor grammatical or spelling changes have been made without acknowledgment. Only substantial comments are listed.

2. Table 1 (page 2–44) lists comments and responses relating to the third draft of the risk management evaluation on PFOA, its salts and PFOA-related compounds and table 2 (page 45–122) lists those to the second draft.

Table 1. Comments and responses relating to the third draft of the risk management evaluation on PFOA, its salts and PFOA-related compounds

Source of Comment Para

Comments on the third draft of the risk management evaluation on PFOA, its salts and PFOA-related compounds

Response

Australia List of substances

The following comments are in response to the drafter’s comments on the submission of the second draft of the PFOA, its salts and related compounds Risk Management Evaluation (RME; Party’s round of comments). In response to comments on the second draft RME on PFOA, its salts and related compounds, the drafters indicated they may not have understood the nature of the comments or required further information to understand the comments.Regarding the structure of the tables used to identify a non-exhaustive list of substances covered or not-covered by the risk management evaluation on PFOA, its salts and PFOA-related compounds, there are continued concerns that the presentation of information in this document is complex and prone to misinterpretation. Given that this document may support implementation of these compounds were they agreed to be listed, Australia believes greater clarity would be highly beneficial. A less complex approach would separate the chemicals that are within the scope of the definition in the RME from those that are not (for example, two separate tables with much less unused “metadata” entries for each substance). This has proven to be an issue in the past for implementation of new POPs chemicals.Another comment that may aid in possible implementation is that further consideration might be taken of the OECD document, “ENV/JM/MONO(2006)15: Lists of PFOS, PFAS, PFOA, PFCA, Related compounds and chemicals that may degrade to PFCA” , and the open access article, “Perfluoroalkyl and Polyfluoroalkyl Substances in the Environment: Terminology, Classification, and Origins” by Buck et al (2011). These documents provide valuable interpretive guidance. The open access Buck et al article provides very valuable guidance on the nomenclature of PFAS group substances which would again enhance the utility of this background document for possible implementation purposes.Regarding the drafters request for clarification of comments regarding data quality, experience suggests that compiling large tables of chemical identity data for chemicals with complex nomenclature in word processing documents is prone to development of inaccuracies. This risk can be reduced by compiling the primary data in a spreadsheet and running some quality

The drafter consulted Buck et al., 2011 and re-categorised some of the substances in the non-exhaustive list of substances, specifically those previously categorized as “other substances” or “others”.Further, we followed your advice, to split the list into two: one list with substances in scope and one list with substances out of scope.In order to enable QA procedures as suggested by Australia, we transferred the list into two separate spreadsheets. Australia offered to assist with the quality assurance step, if the spreadsheet can be provided electronically. To this end, the spreadsheet was sent to Australia on 29 June with the question whether they could carry out QA procedures as offered. Response Australia on 10.7.2017 (QA procedures were carried out; one duplicate CAS had to be removed.The non-exhaustive list of substances will be submitted as a spreadsheet to the Stockholm Convention Secretariat.

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Response

assurance checks. For example, it is possible to run a simple check on the validity of compiled CAS RNs using the check-sum procedure. Other checks for formatting, duplicates and consistency of naming against primary reference lists are also more easily done when the chemical identity information is first compiled in a spreadsheet.The recommendation from Australia that the data for these tables be compiled in a spreadsheet form would aid data verification using QA procedures. Australia would be able to assist with this quality assurance step on the chemical identity information if the spreadsheet is able to be provided electronically.

Belarus 27(e) The first sentence should be placed between the words … December 31, 2015 and Furthermore, in October 2016 (in accordance with chronological description)

Edited

Belarus Sections 2.2.1 and 2.3.2

The name of spheres or products of PFOA, its salts and PFOA-related compounds uses should be highlighted in the text.

Edited

Canada Section 2.5.2

Canada has recently published information on the monitoring of PFOA in Canada. This information and recent publication could be useful to add to the Risk Management Evaluation; therefore, we would like to submit an additional paragraph to the drafters to be included in the “Status of control and monitoring” section (section 2.5.2).Add ““In Canada, monitoring in environmental media and biota is used to evaluate the effectiveness of risk management controls and to measure progress towards eliminating PFOA in the Canadian environment. In addition, monitoring of PFOA is carried out as part of the Northern Contaminants Program which was established in 1991 in response to concerns about human exposure to elevated levels of contaminants in wildlife species that are important to the traditional diets of northern Indigenous people (NCP 2013). Synopsis reports are published on an annual basis and the most recent report is available at http://pubs.aina.ucalgary.ca/ncp/Synopsis20152016.pdf. Additional information on the program is available at http://www.science.gc.ca/ncp .”

Edited.

Canada 5 The Regulations title includes 2012 but the amendments that added PFOA were published in 2016.

Edited

Canada 27(e) Official name for the Act contains the year. Edited

Canada 27(e) Added text as the publication was June 1, 2017.“Participating companies met the targets under the Agreement and the final report was published on June 1, 2017 (refer to http://www.ec.gc.ca/epe-epa/default.asp?lang=En&n=AE06B51E-1)

Additional information included and reference added in footnote

Canada 49 Edited to take into consideration the final report published on June 1, 2017.“The 2010 reduction target was met by all signatories and the final report shows that the 2015 target has been met (refer to: http://www.ec.gc.ca/epe-epa/default.asp?lang=En&n=AE06B51E-1). “

Sentence adjusted as proposed

Canada 82 Delete sentence: “In Canada, this limit is 10ppm for aqueous film forming foam (comment IPEN, 2017).This concentration limit pertains to PFOS, not PFOA.

Sentence deleted as proposed

Canada 203 Please note that the restriction in Canada excludes manufactured items. This includes service and

The statement “…, though in existing restrictions such an exemption was not

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http://www.ec.gc.ca/epe-epa/default.asp?lang=En&n=AE06B51E-1

http://www.ec.gc.ca/epe-epa/default.asp?lang=En&n=AE06B51E-1




Response

replacement parts; therefore an exemption is included in the Canadian restriction. Therefore, since the Canadian approach includes an exemption, it is not accurate to state that “in existing restrictions such an exemption was not considered necessary”.A consistent approach should be used when considering exemptions. Is the fact that an exemption is included in one jurisdiction enough to support including the exemption in the RME? If so, then this should also apply here. The EU exemptions are not being subject to further scrutiny or further justification.It is not clear why this exemption requires further justification when exemptions included in the EU restriction are not subject to the same approach.

considered necessary” was deleted.Asking for specification on relevant parts and sound justification is an analogue approach as it was done when considering an exemption for automotive spare parts in the listing process of decaBDE.The drafter considers it a consistent approach that the POPRC uses all information available (science based and other) and intends to base its decisions on science based information as far as possible. This should be considered consistently by the POPRC.The drafter understands that the Canadian approach is to exclude automotive spare parts by default because they are manufactured items, which are outside the scope of the Canadian legislation, and not because of a specific assessment for automotive spare parts.Therefore the drafter considers it appropriate to ask industry to provide (if possible science based) specification on relevant automotive service and replacement parts as well as sound justification why an exemption would be required.Industry is invited to provide relevant information for the discussion at the POPRC meeting.

China 4 This may be an implicit criticism of these countries. It is suggested to be modified as ‘The voluntary phase out does not include manufacturers using PFOA in countries who were not part of the voluntary efforts.

Adjusted as follows: The voluntary phase out does not include manufacturers using PFOA in countries that were not part of the voluntary efforts, i.e. including those having large manufacturers and/or users of PFOA like China, India and Russia.

China 7 Text: latex printing inksComment: This use is not included in the uses in paragraph 11 for which the Committee recommends to consider specifying exemptions. In paragraph 67 and 184, exemptions for latex printing inks in EU and Canada are indicated, therefore it is inconsistent whether there is a need for exemption of latex printing inks among paragraph 7, 11, 67, 184. And the situation in developing countries is not shown. It is suggested to make an analysis whether to give exemption for this use taking into consideration of additional information of developing countries.

As indicated in para 184 "Depending on when restrictions under the Stockholm Convention for PFOA, its salts and related compounds would possibly enter into force, an exemption may not be necessary for latex printing inks."Therefore, we would suggest discussing this issue at the POPRC meeting.

China 9 Text: do not exhibit POPs characteristicsComment: This is not precise as it is conflicting with the research review of 6:2 FTOH (paragraph 103 to 107). Actually, the evaluation of POPs characteristics of existing alternatives is not sufficient.

To be discussed at the POPRC meeting.

China 82 It is suggested to be clear that whether the estimated substitution costs are one-off costs or including operating costs.

There is no direct specification whether the costs include operating costs but the table in ECHA 2015a

China Background doc

Suggestion to replace PBFS by PFBS Edited

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Response

Germany General The EU-commission recently published the EU-restriction on PFOA. Please update the document.

Edited

Germany 96 The drafters are right (response to comments document) that the second German case is more related to short chain PFAS and should be moved to section 2.3. Some more details were added to the first case to better illustrate the consequences of such a pollution: In Germany, there are is one prominent case showing

the consequences of (illegal) disposal of waste/sludge on agricultural fields. Because of the disposal of industrial sludge PFOA leached into the surrounding surface water and a drinking water reservoir – Lake Möhne – was polluted (see Skutlarek et al. 2006, Wilhelm et al. 2009, Wilhelm et al. 2010, Hölzer et al. 2008, Hölzer et al. 2009). The drinking water thus contained elevated levels of PFOA. Thus, human biomonitoring studies showed higher PFOA levels in blood from people living in Arnsberg compared to inhabitants of a nearby area which received drinking water from a different source.

Please consider also the following information on costs:

According to information from the media the purification costs for the groundwater of about 2.5 million Euro have been incurring since 2006. The purification plant will be operated during the next years and operating costs are about 100.000 € per year. The costs have to by beard by the community according to the results of a court case (https://www.wp.de/staedte/altkreis-brilon/ruhrverband-klagt-im-pft-umweltskandal-auf-schadenersatz-id9731569.html).

EditedNote: the second case has been adjusted and moved to section 2.3 to show that pollution with short-chain PFAS is a heavy burden for the community/society (according to your comment on section 2.3.)

Germany 97/98 Please add the following text:In 2005 PFAS containing firefighting foam has been used at Düsseldorf Airport because of a plane crash and firefighting trainings. PFAS (also PFOA), contaminated soil and leached into groundwater. The PFAS containing groundwater polluted two lakes nearby which are now closed for the public, the consumption of fish is prohibited. In 2007 the local environment authority of Düsseldorf found elevated PFAS levels in the north of Düsseldorf. In the next years the airport Düsseldorf was found to be the main PFAS-source. The remediation of the groundwater will take years or even decades. Further, about 3000 tonnes of soil polluted with PFAS were excavated and disposed off. https://www.dus.com/de-de/konzern/unternehmen/verantwortung/umweltschutz/gew%C3%A4sserschutz/grundwassersanierung). Other airports in Germany have similar PFC contaminated areas resulting from the use of AFFF for training purposes in the past (i.e. airport Nurnberg). The costs of such remediation actions were discussed in the EU-PFOA restriction proposal.

Edited.A new para has been inserted below para 95.

Germany Section 2.3

Please add the following para to show that pollution with short-chain PFAS is a heavy burden for the community/society.In Germany more than 450 ha of agricultural fields were polluted with PFAS most probably by intermixing paper sludge with compost. PFAS have been found in elevated concentrations in soil and groundwater. Short-chain PFAS are the main contaminants in this area. As a consequence, two drinking water wells were closed. Because short-chain PFAS can be taken up in the edible part of the plants and crops have been shown elevated

EditedNew para below para 154

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https://www.dus.com/de-de/konzern/unternehmen/verantwortung/umweltschutz/gew%C3%A4sserschutz/grundwassersanierung






Response

levels of short-chain PFAS, before harvesting PFAS levels in crops need to be analysed in this area. Only crops not enriching PFAS can be cultivated and harvests showing elevated levels of short-chain PFAS cannot be consumed by humans or used as feed. A solution to purify the soil or to stop short-chain PFAS reaching the groundwater has not been found yet. Because of the large polluted area, excavation does not seem to be appropriate. The overall consequences for the inhabitants, the public and the farmers are immense. The costs for remediation and water purification and the supply for clean drinking water are higha (Comment Germany 2017 on 2nd draft RME).

Germany 122 Please add at the end of the para: “Already now short-chain PFAS are ubiquitously present in the environment, even in the remote areas (e.g. Zhao et al., 2012)”Environ Pollut. 2012Distribution and long-range transport of polyfluoroalkyl substances in the Arctic, Atlantic Ocean and Antarctic coast.Zhao Z1, Xie Z, Möller A, Sturm R, Tang J, Zhang G, Ebinghaus R.

Edited.Note: This section (2.3.2) relates to sector specific aspect of alternatives. Risks related to short chain fluorinated alternatives are currently expressed in para 154. Therefore the information has been added to para 154 in section 2.3.4.

Germany 123 (Fluorocouncil’s statement) Please move this para further up, before para 118, because it may be read as a summary of the whole section.

Edited

Germany 141 Please add the following para below para 141: “The institute for fire and disaster control Heyrothsberge in Germany tested six fluorine free alcohol resistant firefighting foams and one PFAS containing foam for their ability to extinguish fires of five different polar liquids. The authors conclude that there are fluorine free foams available which show a similar performance compared with PFAS containing foams ( http://www.idf.sachsen-anhalt.de/fileadmin/Bibliothek/Politik_und_Verwaltung/MI/IDF/IBK/Dokumente/Forschung/Fo_Publikationen/imk_ber/bericht_187.pdf)”

Edited

Germany 179(h) Please use the official name: German Environment Agency (not federal and not EPA)

Edited

Germany Section 2.5.2

Please add a para: “PFAS including PFOA are monitored in human blood samples and urine from children and young adults. In the German Environmental Survey (GerES V) data are generated for the period from 2014-2017, PFAS is only one part of the study. The study also examines sources of pollutants such as indoor air and drinking water. (https://www.umweltbundesamt.de/en/topics/health/assessing-environmentally-related-health-risks/german-environmental-surveys/german-environmental-survey-2014-2017-geres-v#textpart-1)

EditedNew para below para 183

India General The draft risk management evaluation suggested that appropriate alternatives may currently not be available for several uses and therefore suggested for exemptions in few sectors. Limited information on PFOA is available but it is expected that the chemical might be in use in some of the sectors such as textile, Teflon production, etc. It is submitted that even if the alternative is developed in due course of time, the realignment of very

To be considered at POPRC-13.

a To date there is no scientific paper available, but some information is provided by the local authorities (in German see http://www.landkreis-rastatt.de/,Lde/PFC.html and http://www.baden-baden.de/stadtportrait/aktuelles/themen/pfc-problematik/.

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https://www.umweltbundesamt.de/en/topics/health/assessing-environmentally-related-health-risks/german-environmental-surveys/german-environmental-survey-2014-2017-geres-v#textpart-1



http://www.baden-baden.de/stadtportrait/aktuelles/themen/pfc-problematik/


http://www.landkreis-rastatt.de/,Lde/PFC.html




Response

complex and expensive industrial processes will take substantial time to be completed. India therefore needs timely and appropriate technical assistance, technical information on alternatives to PFOA, its salts and related compounds, technology transfer and financial support for successfully reducing or eliminating releases from these chemicals.

Japan 10 Since it is recommended to add to Annex C in 2.1, is it also necessary to mention it here?

Edited. (…consider listing … …in Annex C, as an unintentional POP to capture potential formation and unintentional release from anthropogenic sources)

Japan 12 "of fluoropolymers" should be added in according to FOEN 2017

Edited


Edited

Japan 74 We added technically reasons and literature, based on comments of secretariat.“According to the literature, PFOB could be technically produced from PFOH (perfluorooctyl hydride; C8F17- H)17. However, the production of PFOH requires PFOI as a raw material, and also the use of PFOH provided insufficient yield to be commercially viable compared to PFOI. In addition, the reaction with PFOH takes place at around 500 °C, compared to 140 °C for PFOI, which makes the reaction with PFOI significantly more energy-efficient. Therefore, current production process starting from PFOI18 is the only reasonable way to produce PFOB. It is estimated that about ten tons/year of PFOI could be used in 2020 for these applications by a company.”

New information and additional literature sources included

Japan 74 PFOI is produced at one single site in Japan during the production of 6:2 fluorotelomer-based substances, and then transported as isolated intermediate to another site in Japan to produce PFOB. Afterwards, PFOB is transported to two sites in the US to produce relevant pharmaceutical products (comment Daikin 2017 on 2nd draft RME).

Additional information included

Japan 74 The production of PFOB takes place at another site in Japan than the PFOI production site, therefore the special provisions for closed system and site-limited intermediates as stipulated in the Stockholm Convention could not be used. Nonetheless, it is our understanding that an exemption for transported isolated intermediates in order to enable reprocessing in another site than the production site, as mentioned in paragraph 215 (i), would be a suitable exemption.Proposal to adjust the last sentence of para 74 as: “An exemption for transported isolated intermediates in order to enable reprocessing in another site than the production site could be used instead of a specific derogation.”

Since the production of PFOB takes place at another site in Japan than the PFOI production site we consider that the special provisions for closed system and site limited isolated intermediates do not apply. As a consequence, the last sentence of this para is considered obsolete and was deleted.

Japan 104 The literature cited here refers to “industrial companies have investigated the manufacturing and use properties of perfluorocarboxylate (PFC) with a carbon chain length of six carbon atoms and related C6 telomers. Because of the acceptable performance characteristics of these substances, industrial companies are also studying the health and environmental profile of these promising alternatives”. There is no specific mention of Daikin. Therefore, the reference to “Daikin” should be removed.

Not editedDaikin is stated in (Wang et al., 2013) “Fluorinated alternatives to long-chain perfluoroalkyl carboxylic acids (PFCAs), perfluoroalkane sulfonic acids (PFSAs) and their potential precursors” cited from (Iwai, 2011).

Japan 197 As already indicated in our comments to paragraph 74, “According to the literature, PFOB could be technically

As outlined in the response to comment 74 the verification whether the closed-

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Response

produced from PFOH (perfluorooctyl hydride; C8F17- H). However, the production of PFOH requires PFOI as a raw material, and also the use of PFOH provided insufficient yield to be commercially viable compared to PFOI. In addition, the reaction with PFOH takes place at around 500 °C, compared to 140 °C for PFOI, which makes the reaction with PFOI significantly more energy-efficient. Therefore, current production process starting from PFOI is the only reasonable way to produce PFOB. It is estimated that about ten tons/year of PFOI could be used in 2020 for these applications by a company.”As already indicated in our comments to paragraph 74, the production of PFOB takes place at another site in Japan than the PFOI production site, therefore the special provisions for closed system and site-limited intermediates as stipulated in the Stockholm Convention could not be used. Nonetheless, it is our understanding that an exemption for transported isolated intermediates in order to enable reprocessing in another site than the production site, as mentioned in paragraph 215 (i), would be a suitable exemption.

system site-limited intermediate exemption could apply is obsolete. We therefore deleted the sentence “It should also be verified, whether the closed-system site-limited intermediate exemption (see Stockholm Convention text, note (iii) of Part I of Annexes A and B) or exemptions for transported isolated intermediates could be relevant for this use.”Text complemented and adjusted as follows:“According to information provided, the current production process starting from PFOI is considered the only reasonable way to produce PFOB. Therefore an exemption should be considered for the use of PFOI for the production of PFOB for the purpose of producing pharmaceutical products.”This possible specific exemption was added to the concluding statement: para 215 j: “The use of PFOI for the production of PFOB for the purpose of producing pharmaceutical products (time limited or not (Annex A or B))”Stakeholders are invited to provide relevant information for the discussion at the POPRC Meeting on the question whether an exemption is justified or not and whether it should be time limited or not.


Edited

Norway General The document gives the impression that all requests for exemptions have been accepted and that no critical review of the exception requests that have come from industry or industry organizations have been made. It appears that most of the exceptions included in the EU Restriction are also included automatically, without a critical review of the needs for these globally. Even when alternatives are available, exemptions are suggested.

In the document the drafter analysis the information provided by Parties and observers in order to create a discussion basis for the upcoming POPRC13 meeting.In doing so, the drafter uses the information provided by Parties and observers. The information provided and available to the drafter does not always allow a critical and conclusive review of the needs globally for each possible exemption.At the meeting, the POPRC can review and discuss the available information related to each possible exemption and decide whether the information available justifies an exemption or not and/or whether additional information will be required to come to a decision.For firefighting foams a specific time limited exemption is proposed though alternatives are available. Germany, supported by Austria, proposes to include a transitional period for the use of the “old” foams, since the firefighting foams are very stable and may be stored for very long time until used in the case of fire. Thus, the effect of reducing emissions is rather low in

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this case (see para 83). The relevant uses of AFFF are exempted or not covered in the existing restrictions. Therefore the drafter concludes that exemptions should be considered under the SC. However, the decision will be subject to discussion at the POPRC meeting.

Norway 5 Paragraph should be updated with Regulation (EU) no. 2017/1000, cfr. Also footnote no 10.

Edited

Norway 5 Text: Norway published an amendment to the Norwegian consumer products regulation in 2014, which bans the use of PFOA in consumer products and textiles with: It had a transitional period allowing the import and sale of products manufactured before the phase-out. Since 1 June 2014, it has been prohibited to manufacture, import, and export and make available on the market textiles, carpets, other coated consumer products and consumer products that contain PFOA and individual salts and esters of PFOA with exemptions.Comment: This text can be deleted. Too much detail for the executive summery and the text is almost identical to the text under section 1.5.

EditedThe text has been shortened as follows:“The Norway bans the use of PFOA in consumer products and textiles since 2014 with certain exemptions.”

Norway 5 Is it not implemented in COMMISSION REGULATION (EU) 2017/1000 of 13 June 2017?

Yes. Updated.

Norway 5 This text should be made much shorter. It is also very repetitive to text throughout the document.

Shortened (see previous comment)Note: The legislative text from section 2.2. was moved to the background document to shorten the text and to avoid repetition.

Norway 11 What committee recommends? The POPRC. This is common wording from other RMEs (see e.g. RME on decaBDE)

Norway 26 In 2003?? We do not have this information. In 2003 or before 2003 since, as a result, PFOS was added on the list of chemicals for priority action in 2003.

Norway Table 3 It is informative to have this overview in this chapter. The RME could be shortened by removing repeated information of these regulations from later parts of this document.

Edited. Paras 41 to 44 moved to the background document.

Norway Table 3 What about the restriction implemented in China? Should it not be included in the table?

Control actions in China are indicated in para 27(h). The approach in China is different from restricting with exemptions. Therefore it is not possible to compare it with the restrictions in Table 3.

Norway Table 3 Text: Not covered but exempted due to restriction of aqueous film-foaming firefighting foams for professional use onlyPlease change to "Not covered by the restriction."

Edited

Norway 33 May add footnote to where to find this information:https://echa.europa.eu/registry-of-current-restriction-proposal-intentions/-/substance-rev/16121/term

Edited

Norway 37 Might also refer to the COP decision: UNEP/POPS/COP.8/CRP.13

Not edited. The passage has been deleted according to a comment from POPRC member-2.

Norway 41 No need to repeat this as text when it is already mentioned in the table above.

Text adjusted and moved to the background document

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Response

Norway 42 In table above. Text moved to the background document

Norway 44 In table above Text moved to the background document

Norway 47 may add value here to as for the US regulation:The TDI for PFOS and PFHxS is 0.02 micrograms per kg of body weight; for PFOA the TDI is 0.16µg/kg of body weight. The safe levels in drinking water are for 0.07 micrograms per litre for PFOS and PFHxS and 0.56µg/l for PFOA.

EditedPFOA specific information added for Australia: “In Australia, the TDI for PFOA is 0.16µg/kg of body weight. The safe level in drinking water is 0.56µg/l for PFOA.”

Norway 73 Reprocessing of what? Of isolated intermediates; edited

Norway 80ff (sub-heading “Firefighting foams”

It is questioned if this is a critical use.https://echa.europa.eu/regulations/substituting-hazardous-chemicals/examples-from-real-life/fluorine-free-foams

It should be discussed at the POPRC whether exemptions for fire-fighting foams should be recommended. It is already stated in para 80, that for fire-fighting foams containing PFOA-related substances a number of alternatives exist (referring to paras 135 to141).

Norway 83 May not be necessary to refer the product regulation from Norway here. The duty to substitute hazardous chemicals with more environmental friendly alternatives has led to replacement of fluor containing AFFF with fluor–free foam on civil airports and military properties and offshore in Norway.

Comment noted

Norway 84 This paragraph could be moved to para 96-96: Recent calculations of the total costs for cleaning up groundwater polluted by PFAS around fire-fighting areas in Norway show that 3,5-5,5 mill Euro is required per training site. These numbers include investment and operation of groundwater cleaning systems necessary in some Norwegian airports polluted by PFAS from fire-fighting foams. Chemical analysis show that PFOA migrates into the ground water to a higher extent than PFOS.

Edited (para moved below para 95).Further we have used the cost information to complement this para.

Norway 94 In addition, Greenpeace has a review of the market: http://www.greenpeace.org/international/Global/international/publications/detox/2017/PFC-Revolution-in-Outdoor-Sector.pdf

Comment noted. Greenpeace demonstrated that the transition to PFC-free alternatives was possible in the outdoor sector. The information does not really fit into this section on costs and benefits of implementing control measures.

Norway 95 Recent calculations of the total costs for cleaning up groundwater polluted by PFAS around fire-fighting areas in Norway show that 3,5-5,5 mill Euro is required per training site. These numbers include investment and operation of groundwater cleaning systems necessary in some Norwegian airports polluted by PFAS from fire-fighting foams. Chemical analysis show that PFOA migrates into the ground water to a higher extent than PFOS.

Edited. This information is used in a new para below para 95 (see also response to comment on para 84)

Norway 97 PFAS has also contaminated drinking water for 15 mill inhabitants and several sites in USA. (http://www.ewg.org/research/mapping-contamination-crisis).

Edited

Norway 137 The distinction between a detergent and a surfactant is meaningless and intended to confuse the issue, also which modern foams other than FP and FFFP still use protein

Deleted

Norway 137 Suggestion to add: Edited

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http://www.ewg.org/research/mapping-contamination-crisis

http://www.ewg.org/research/mapping-contamination-crisis

http://www.greenpeace.org/international/Global/international/publications/detox/2017/PFC-Revolution-in-Outdoor-Sector.pdf



https://echa.europa.eu/regulations/substituting-hazardous-chemicals/examples-from-real-life/fluorine-free-foams

https://echa.europa.eu/regulations/substituting-hazardous-chemicals/examples-from-real-life/fluorine-free-foams




Response

Norwegian Airports, military properties and several offshore companies has also introduced fluorine-free foams (comment Norwegian Environment Agency, 2017).

Norway 138 This is old information Yes. Can you provide up to date information?

Norway 138 This is also old information See previous comment

Norway 138 Suggestion to add:“Lifetime costs for using AFFF, FP, or FFFP far outweigh those of fluor-free- foams just because of legal and financial liabilities of using a fluorochemical based foam (see Queensland Policy and Explanatory Notes) as indicated above which include infringement of operating license conditions, reputational and brand image damage – see article in IFJ (attached – IFJ article Q4 2013). Increasing evidence suggests that fluorochemical contamination of groundwater is an ongoing serious issue impacting agriculture, fisheries, property prices, with considerable political and public concern fallout resulting in hugely expensive and damaging and legal challenges (ref: all the various class actions in the US). Remediation costs are still substantial, especially off-site, compounded by high analytical and consultancy costs in the case of environmental contamination with fluorinated breakdown products from an AFFF, FP or FFFP.”

Edited

Norway 139 Text: However, stringent performance requirements can often not be achieved.Comment: Not correct:Stringent performance requirements has been achieved; fluor-free-foam (3F) are widespread use by airports, oil companies, etc. see attached document RF- END USERSSee also chapter 8 in Environmental Management of Firefighting Foam Policy – Explanatory Notes (Revision 2), Department of Environmental and Heritage Protectionwww.EHP.qld.gov.au ABN 46 640 294 48http://www.ehp.qld.gov.au/assets/documents/regulation/firefighting-foam-policy-notes.pdfSuggestion to add: Many fluorine-free foams are acknowledged as “meeting the toughest amongst the firefighting standards” and are widely used by airports, oil companies etc.

Edited.Reference added (Queensland Gov., 2016)

Norway 140 Be aware that there are a very strong lobby among fluorosurfactant foam producers and several are members of FFFC.

Norway 140 Which users? Not specified. Text adjusted according to the source (Swedish Chemical Agency, 2015) to “some users”According to the source, the information stems from a Personal communication with Jan-Erik Jönsson, Dafo Fomtec AB. The viewpoint of a supplier of firefighting foam on the development and use of firefighting foam. Network meeting on highly fluorinated substances 23 April, 10.00-16.00, at Stockholm University, Stockholm. 23/04/2015.

Norway 140 Text: Compared to fluorine-based firefighting foams Same information source as previous

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http://www.ehp.qld.gov.au/assets/documents/regulation/firefighting-foam-policy-notes.pdf




Response

approximately twice as much water and foam concentrate are needed when extinguishing liquid fires.Comment: Where does this information come from?

comment: The viewpoint of a supplier of firefighting foam

Norway 140 Text: In foam degradation tests, fluorine-free foam degraded after 1-2 minutes, while the AFFF lasted 35 minutes before it has been degraded.Comment: Where does this information come from?

From a factsheet of the FFFC (http://www.fffc.org/images/AFFFfactsheet17.pdf)

Norway 140 Suggestion to add:However, blockage factors (i.e. vapour suppression) was indistinguishable between a fluor-free-foam and two AFFFs tested (Williams et al. 2011)Comment: Williams et al 2011 Orlando SUPDET (attached)

EditedAdded at the end of the para

Norway 140 Suggestion to add:However, airports and offshore companies around the world have introduced fluor-free foam and are satisfied by the performance.

Edited

Norway 140 FFFC are a fluoro industry lobby group not representative of the firefighting foam industry as a whole and as such this opinion is biased

Yes. It is made clear that this statement stems from the FFFC.

Norway 215 The Committee recommends to consider specifying exemptions and/or acceptable purposes for the following uses:

We agree. Here we use the term “exemption” which includes the option to recommend both, “specific exemptions” or “acceptable purposes”.Please note what we have explained in the response to a comment from the Netherlands on para 7 of the 2nd draft RME: Exemptions recommended by the

POPRC could be either specific exemptions (in Annex A or B) or acceptable purposes (only in Annex B).

The drafter considers specific exemptions appropriate if the ultimate objective is to end an activity (production or use) in the future.

The drafter considers an acceptable purpose could be appropriate if it is considered that an activity will have to be continued in the long range future (i.e. without time limit or if a very long phase-out time is required e.g. over many decades).

Further, the drafter considers that, if the ultimate objective is to end an exempted activity in the future (which corresponds to elimination), listing in Annex A with a specific exemption should be preferred over listing in Annex B with a specific exemption or an acceptable purpose.

Norway 215(a) This means that acceptable purposes are recommended. This means that an acceptable purpose (not time limited) or a specific exemption (time limited) can be proposed, depending on the outcome of the discussion at the POPRC meeting.

Russian General We reviewed the draft risk management evaluation In para 186 (not 172) it is stated that

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http://www.fffc.org/images/AFFFfactsheet17.pdf




Response

Federation "Pentadecafluorooctanoic acid (PFOA, perfluorooctanoic acid), its salts and PFOA related compounds (hereinafter – the Project), and reports.In para 172 submits that "PFOA is persistent, bioaccumulative and toxic to animals, including humans". However, the authors of the Project make these conclusions on the basis of circumstantial evidence, as there are no methods of determination of PFOA in living organisms and environmental objects. This implies that all available information about the accumulation and negative effects of PFOA cannot be considered as objective and reliable.The lack of standardized method of analysis the presence of PFOA in different matrices at present (p. 18) is significant. At the same time, cost of research and development represents a significant financial burden (p. 81).In para 6 indicates that "currently, there are no alternatives available for several kinds of use". In para 73 states that “the major producers of fluoropolymers has developed several alternatives for replacing the use of PFOA". "Accordingly, it is assumed that the use of alternatives leads to a moderate increase in production costs (0-20%). This increase is due to higher costs and/or higher number of alternatives that will be applied".Information about the existence of safe alternatives to PFOA in the Russian Federation is missing.In connection with the foregoing, we consider the inclusion of PFOA in annexes A and/or B to the Stockholm Convention is premature.We consider that it is necessary to undertake appropriate scientific research and analyses to meet the requirements specified in Annex F and to discuss this issue at upcoming meeting of the POPRC-13 in October 2017.

PFOA is persistent, bioaccumulative and toxic to animals, including humans. This statement is a result of the Annex E evaluation and was adopted by the POPRC in the risk profile (UNEP/POPS/POPRC.12/11/Add.2). The Annex E discussion is terminated.Methods (including standardised) for the determination of PFOA in different matrices are available and stated in the document (see para 21)Regarding cost of research and development representing a significant financial burden, it seems that the comment refers to an industry statement (see para 99).These and further issues can be discussed at the POPRC meeting.

Sweden 4 Consider adding that the US Food and Drug administration have introduced requirements related to PFOA and products in contact with food, as mentioned in para 144

We do not have specific information on FDA approval requirements. See response to comment on para 144

Sweden 4 Suggestion to add “with manufacturers” EditedWe assume the programme was also in Canada with manufacturers

Sweden 4 Suggestion to delete “and thus are not subject to the voluntary phase-out goal of the program”Comment: Consider deleting as it seems obvious.Consider adding some information about the SAICM initiated global PFC-project, with the aim to include manufacturer outside US, Europe and Japan

Edited(Deleted; information on the SAICM issue of concern “Perfluorinated chemicals and the transition to safer alternatives” has been added to this para and para 27).

Sweden 37 Consider making the listing proposal for Annex C clearer. It is not entirely similar with SCCPs/MCCPs where there was no listing in Annex C, while here the proposal for PFOA is Annex C listing in relation to inadequate incineration

We tried to make Annex listing clearer here and added substantial information to section 2.2 (below para 45)

Sweden 38 Text: According to IPEN, the most cost-effective and practicable control measure for PFOA and PFOA-related compounds is the prohibition of all production, use, import and export, which is particularly relevant in developing and transition countries that lack adequate regulatory and enforcement infrastructure.Suggestion to delete “According to IPEN”

Please note that this statement relates to the prohibition of all production, use, import and export (i.e. without any exemptions). Therefore we consider that the statement cannot be made general.

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Response

Comment: This statement could (as proposed in the previous version) be made general and not related to IPEN

Sweden 41 We support further summarizing the information related to the EU proposal and, providing details in the INF

The legal texts of legislative proposals (paras 41 to 44) have been moved to the background document.

Sweden 46 Consider adding here some information about the US Food and Drug Administration food contact approval requirements for oil and grease resistance additives that restricts PFOA- Relates to para 144.

See response to comment on para 144.

Sweden 52 Suggestion to add a new para below para 52:The Swedish Chemicals Agency has published a strategy for reducing the use of PFASs (Swedish Chemicals Agency (2016b)). PFASs applications which could result in environmental contamination should be minimized and ultimately discontinued. Actions to achieve this aim include prioritizing the implementation of measures for uses that can result in substantial direct releases to the environment and work on the global arena including the Stockholm Convention. PFASs-containing fire-fighting foams are proposed to be collected and destroyed after being used (with some exemptions).

Edited

Sweden 53 Suggestion to delete the first sentence and add: …invested in training and information provision for rescue services. Seminars have been held intended to offer the rescue services tools for extinguishing fires in a manner that minimises any impact on the environment.

Edited

Sweden 58 Suggestion to delete the para Edited

Sweden 67 Consider first addressing the non-technical textile if to remain under this heading

Edited

Sweden 67 Suggestion to move the following up in this para:“In Norway, only textiles for consumer use are restricted, while textiles for professional use are not covered.”

Not editedAlso other information on existing legislative approaches is at the end of the para.

Sweden 67 Suggestion to delete “However, for textiles used in outdoor applications (e.g. awnings and outdoor furnishing, camping gear), alternatives are available and an exemption is not proportionate within the EU.”

Edited

Sweden 67 Please rather explain what the Canadian approach does cover with regards to textiles. Not manufactures items?

The Canadian approach prohibits the manufacture, use, sale, offer for sale or import of PFOA and other long-chain PFCAs and products containing these substances but it allows the use, sale, offer for sale or import of manufactured items containing PFOA or LC-PFCAs (see para 42)Canada has provided explanation on this term in its comment on the first draft RME, Table 3: “Under the Prohibition of Certain Toxic Substances Regulations a “manufactured item” is a product “formed into a specific physical shape or design during its manufacture and that has, for its final use, a function or functions dependent in whole or in part on its shape or design.” Examples of manufactured items include semi-conductors and frying pans, but would exclude products such as fire-fighting

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Response

foams, inks, paints, or coatings.”A corresponding footnote has been added to para 27(e)

Sweden 72 and 73 Suggestion to add: “Un-avoidable fraction in the …” Consider putting this sub heading as the last item under this heading as it is not a use

Edited

Sweden 73 Consider providing information about the conditions rather than referring to para 4 cConsider providing information about the conditions could be.

Edited

Sweden 77 As above rather explain what the Canadian approach cover. Not manufactures items?

Please see response to comment on para 67.

Sweden 78 As above rather explain what the Canadian approach cover.

Please see response to comment on para 67.

Sweden 79 Consider to spell out ICT industry Edited

Sweden 79 Consider to spell out SEMI The term SEMI is explained at its first occurrence in para 65

Sweden 104 Consider choosing one of the formulas of ADONA and GenX given in para 103 and 104... Perhaps move one to the INF?

For completeness, we prefer to maintain both formulas here.

Sweden 113ff For this sector consider first describing the non-fluorine containing and non-chemical alternatives as there are PBT concerns with the short-chain as suitable alternatives.

We prefer to stick to the structure which is similar also for the other uses; this does not mean any preference of certain types of alternatives. Concerns about short-chain fluorinated alternatives are expressed in para 154.

Sweden 135ff Also for this sector consider first describing the non-fluorine containing alternatives.

Please see response to previous comment

Sweden 142ff Also here consider first describing the non-fluoride containing alt.

Please see response to previous comment

Sweden 142 Text: 143.142.It was noted that alternative treatments of paper and cardboard used in packaging including short-chain telomer-based compounds have been identified (IPEN, 2016).Comment: Where noted? Should this not rather be an introductory para as it also is about identifying non-fluorinated alternatives for the paper and food packaging sector?

The information stems from the Annex F form provided by IPEN. As source IPEN indicates: “Information from Norwegian Pollution Control Authority (former Statens Forurensningstilsyn), 2009”.

Sweden 144 Suggestion to add the year of approval.It would be good if the section 1.5 could include some info about these FDA approval requirements

The press release (AMR, 2015) is from February 2015. Approval was possibly in 2015 (added)We do not have specific information on FDA approval requirements.The following has been added as a footnote:The substance is approved by the US Federal Food and Drug Administration under 21 CFR 176.170 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=176.170

Sweden 2.3.3 Suggestion to add “for all uses” in the headingComment: For parts of the applications described there are non-PFOA alternatives available.

Edited

Sweden Table 4 Text: Constituent in process chemical formulations (e.g. for photolithographic applications)

Edited

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Response

Comment: Consider if this critical use can be further defined as proposed

Sweden 162 and 187

Suggestion to move text from para 187 to para 162 Edited

Sweden 174 Suggestion to add “and several of the in 2015 globally adopted sustainable development goals”

Edited

Sweden 174 You could consider deleting the info about the GPA. The PFC-group is in this RME likely of more importance to include information about

Edited.

Sweden 179(j) Suggestion to delete “In Sweden training for fire fighters has been provided and a leaflet has been issued to the Swedish Rescue Services with recommendations to reduce the use of firefighting foam (Swedish Chemicals Agency, 2017).”

Edited

Sweden 187 Suggestion to move part of this para to para 162 Edited

Sweden 196 As proposed before, consider writing out these conditions Edited above. A link to the para inserted here.

Sweden 205 Suggestion to add “Also the costs related to the management of contaminated ground water and drinking water would be reduced.”

Not edited. This is already considered in para 209

Switzerland General A number of edits have been made in the following text without specific justification. These edits are made with the intention to improve the language.

Edited as considered appropriate

Switzerland 8 Suggestion to delete “as POP substances”Comment: I’m not sure if all “PFOA-related compounds” are POP substances, but they’re the source of PFOA, which is the reason for the inclusion of these substances?

Edited

Switzerland 16 Suggestion to add: “…and in biota (including humans)” Edited

Switzerland 17 What about making sure that the “not” is not overlooked by adding some kind of emphasis, e.g. underlining?

Edited

Switzerland 24 Suggestion to add Switzerland Not edited.In this para, Parties are listed who submitted an Annex F form (this is now made clear in the text). Switzerland did not submit an Annex F form related to PFOA (see http://chm.pops.int/TheConvention/POPsReviewCommittee/Meetings/POPRC12/POPRC12Followup/PFOAInfo/tabid/5453/Default.aspx).

Switzerland 28 Since side-chain fluorinated polymers are considered as PFOA-related compounds, and the uses of side-chain fluorinated polymers are included in the first part of the sentence. You may wish to consider to delete this part of the sentence, and change the sentence to “PFOA-related compounds, including side-chain fluorinated polymers, are used as surfactants and/or surface treatment agents (e.g., in textiles, paper and paints, firefighting foams).” to make it more precise.

Edited

Switzerland 29 I would suggest changing “major” to “substantial”, as the contributions of individual sources change over time and are dependent on the geographical scale and locations.

Edited

Switzerland 30 Perhaps it’s better to say “MSWI with inappropriate incineration conditions”?

Edited

Switzerland 31 Suggestion to add “with more than eight perfluorinated carbon atoms” and to delete the footnote.

Edited

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Response

Comment: Perhaps it would be easier to just specify the term here, since there is a slightly different definition of long-chain PFCAs a couple of lines down. In this way, the footnote may no longer be needed.

Switzerland Other control measures

I’m wondering whether the controls measures in Russia and China in para 27 need to be mentioned again here.

Edited(information added to para 46)

Switzerland 64 Definition of “critical uses”Comment: This definition is good. But I wonder if there is any consideration if such use is needed in the first place. If the use is not essential to society, then there is no need for replacement, but only phase-out. Therefore, I would suggest to modify it to “uses that are essentially needed by society and for which there may not be accessible …”

Edited“…uses that are needed by society and for which there may not be accessible chemical and/or non-chemical alternatives”.Please note that the term “critical uses” is not any more used in the RME (see comment POPRC member-2 on para 11)

Switzerland 74 Suggestion to replace “derogation” by “exemption” Edited

Switzerland 80 Suggestion to delete “AFFF are unique amongst other firefighting foams in that they contain a small percentage of fluorinated surfactant.”Comment:This is not correct. Many types of firefighting foams may contain fluorinated surfactants, see Wang et al., 2013:“In the past, various PFCA-, PFSA-, and fluorotelomer-based derivatives were added (i) as film formers in aqueous film forming foams (AFFFs) and film forming fluoroproteins (FFFPs), (ii) as fuel repellents in fluoroprotein foams (FPs), and (iii) as foam stabilizers in FFFPs and alcohol-resistant aqueous film-forming foams (AR-AFFFs) (Backe et al., 2013; Kleiner and Jho, 2009; Place and Field, 2012).”Therefore, I would suggest deleting this part.

Edited

Switzerland 91 Text: … according to UNEP/POPS/POPRC.12/11/Add.2, PFOA is presumed to be an immune hazard to humans.Comment: Please consider to use this as a more appropriate reference for this statement: https://ntp.niehs.nih.gov/ntp/ohat/pfoa_pfos/pfoa_pfosmonograph_508.pdf

Edited(The reference is already in the list of references: NTP, 2016)

Switzerland 101 It seems that not in all uses, PFOA and related compounds are being replaced, e.g., in the pharmaceutical production. I would suggest adding “in many applications”.

Edited

Switzerland 104 Text: Other producers, such as Daikin (Iwai, 2011), may have applied ammonium perfluorohexanoate (APFHx) or 6:2 fluorotelomer carboxylic acid (6:2 FTCA, CAS No. 53826-12-3) (Xu et al., 2011) as an alternative to replace PFOA as processing aid (Wang et al., 2013) .Comment: I’m not sure if this information is valid anymore. Daikin has developed its own PFPE-based alternatives as well. Chinese manufacturers are also using other different PFPEs, as indicated in FOEN, 2017. I would suggest removing this sentence and adding one sentence “For further information on alternatives to PFOA as processing aids in fluoropolymer production, see section V in FOEN, 2017.

Edited

Switzerland 105 Suggestion to simplify and adjust the first sentence.Comments: They’re in use now. So no longer “potential”.The structures and CAS numbers have been given in the previous paragraph. I would suggest keeping it short

Edited

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Response

here.

Switzerland 105 Suggestion to delete second sentenceComment: This information has been mentioned in the previous paragraph. I would suggest deleting it here.

Edited

Switzerland 107 This might be a more appropriate reference: https://www.efsa.europa.eu/de/efsajournal/pub/2182

Edited(EFSA 2011b, already in list of references)

Switzerland 108 Text: It was concluded that the toxicity profile for ADONA is acceptable for its intended use as PPA and is superior to the one of APFO.Comment: Please specify who concluded this statement, e.g., by the author.

Edited (“by the author” added)Note: The conclusion was drawn by the Author (Steven C. Gordon, 3M Company, Toxicology Assessment and Compliance Assurance, St. Paul, MN 55144, USA)

Switzerland 111 This paragraph doesn’t provide any useful information. Probably it refers to one of the three PFECAs above? Please consider to delete the paragraph.

Edited(The reference does not specify the substance)

Switzerland 112 This comes a bit too late. I would suggest merging paragraph with the para. 104, by adding it to the end of the paragraph.

Edited

Switzerland 115 Probably also urethane polymers. Please consider to change it to “acrylate, methacrylate, adipate and urethane polymers”

Edited

Switzerland 118 Text: 6:2 FTOH in soil can be aerobically biodegraded to transformation products such as 5:3 acid and other PFCAs (mainly PFPeA and PFHxA).Comment: This sentence contains the same information as the second sentence of the previous paragraph. Please consider to delete this sentence, and to merge the rest of this paragraph with the previous paragraph.The authors may also wish to add a link at the end of this paragraph to the supplementary information on degradation provided by FOEN. For example, “More information regarding the transformation/degradation of 6:2 fluorotelomers can be found in section II of FOEN, (2017).”

Edited

Switzerland 121 Suggestion to add “in wildlife and humans”Comment: Short-chain PFCAs may accumulate more in vegetation than long-chain ones, as indicated below. Therefore, the authors may consider adding the specification here as suggested.

Edited

Switzerland 136 Suggestion to replace “perfluorohexane ethyl” by “6:2 fluorotelomer”Comment: As indicated in the previous commenting round, this name is unclear and uncommon. If you decide to keep it as is, then please add the structure, the CAS RN or similar.

Edited

Switzerland 154 Suggestion to replace “is assumed” by “may be expected”

Edited

Switzerland 154 Suggestion to replace “considered” to “currently in use as”Comment: They’re already in use. I would suggest changing it to “currently in use as”.

Edited

Switzerland 206 Probably it’s better to be more specific. PFOA is recognized as a POP, and the inclusion of PFOA-related compounds is mainly because they are sources of PFOA in the environment and biota.

Edited

FluoroCouncil 4 EPA PS program was global and not restricted to EU, Edited

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Response

Japan and US.

FluoroCouncil 47 Please consider replacing PFCs with PFASs Edited

FluoroCouncil 55 Please consider adding reference to BAT/BEP document Reference to (UNEP, 2017) included

FluoroCouncil 64 “critical uses” in quotation marks and several additional adjustments proposed in para 64

Wording has been changed on other comments received. In the final version of the RME the term “critical” is not used anymore.

FluoroCouncil 68 “..a lot of “ what? Some text is obviously missing… Has been changed to “several textiles”

FluoroCouncil 101 Please consider adding reference to BAT/BEP document Reference to (UNEP, 2017) included

FluoroCouncil 123 C6 monomers were evaluated as well, please add to the list of substances

C6 monomers added to the list of substances as proposed

FluoroCouncil 154 Not true or demonstrated for ALL short-chain PFASs, please consider editing text as suggested. “The higher solubility in water compared to long-chain PFASs with more hydrophobic alkyl chains also contributes to the fact that some short-chain PFASs do enter drinking water reservoirs faster and certain tend to accumulate in water-rich edible plant tissues like e.g. leaves and fruits. The presence in groundwater and drinking water might lead to a continuous exposure of organisms to certain short-chain PFASs, currently still at a relatively low level, but given the high persistence and the increasing use of these substances a temporal increase in environmental concentrations is assumed.”

Edited

International POPs Elimination Network (IPEN)

General As we previously stated we find it inappropriate that the consultation firm BiPRO has served as a/the drafter for this RME. The firm has industry clients including 3M, Saint Gobain, the European Chemical Industry Council (CEFIC), and other chemical corporations that may be involved in the manufacture of PFOA and related substances. This calls into question the objectivity of the RME, and in particular, the assessment of the need for exemptions and evaluation of alternatives. Despite claims of objectivity by BiPro, for a company that has as a client one of the main producers of the chemical under consideration, BiPro’s conflict of interest for perception of conflict of interest cannot simply be denied or easily dismissed. It is necessary for impartial POPRC members themselves or independent, unbiased consultants to prepare the RME in order to prevent conflict of interest.The objectivity of the RME is called in to doubt when the absence of data justifying a requested extension, is accepted as a reason for presenting a statement that no alternatives exist. For example the RME refers to the need for an exemption for “filtration in water treatment, production processes and effluent treatment.” Yet, no information is provided as to what production processes are involved, what form of water treatment or effluent treatment is affected, or the economic or technical issues involved.It is not corporations’ right to request exemptions or extensions of exemptions under provisions of the Convention. Concerning extensions beyond the requisite five year period allowed for exemptions, according to Article 4, “The Conference of the Parties may, upon request from the Party concerned, decide to extend the expiry date of a specific exemption for a period of up to five years. In making its decision, the Conference of the Parties shall take due account of the special circumstances of the developing country Parties and Parties with economies in transition.”

Could be discussed at the POPRC meetingSee also response to general comments from IPEN on 2nd draft

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Response

In other RMEs, information is first presented on alternatives, and then there is a discussion about possible lack of alternatives for certain uses. That is the format this RME should follow instead presenting an industry wish list as a perceived certainty followed by information on alternatives.The RME must include an unbiased evaluation and justification for the need for each possible exemption and a full assessment of safe alternatives. In addition, the specific function PFOA provides for the application that needs to be replaced should be detailed out in order for a fair assessment of alternatives to be made. Not all PFOA properties are useful in all applications.Time limited exemptions should be limited to those that are fully justified, with the provisions of Article 4 in mind.The argument that a ban on manufacture, sale and export with an exemption is a restrictive approach rather than a regulatory approach is semantic and clearly demonstrates a bias towards the concept of restriction rather than elimination which is the aim of the Stockholm Convention. Despite claims to the opposite, the term restriction under the Convention has a clear meaning i.e., Annex B listing. The use of the term restriction in this document clearly relates to the terms used in the EU ‘ANNEX XV PROPOSAL FOR A RESTRICTION – Perfluorooctanoic acid (PFOA), PFOA salts and PFOA related substances’. If it is not the intention to bias the RME, then we again request the drafter remove the term restrictive approach and replace it with regulatory and/or non- regulatory approaches.The repeated use of the term derogations in regards to the Stockholm Convention is inappropriate as it is an EU term and not used in the Stockholm Convention.

IPEN 4 Yet, the document recommends an exemption for waste water treatment with no justification or examination of the need. See later comment.

Comment noted

IPEN 6 These are all regulatory approaches so the argument that the term regulatory approaches are inappropriate is rejected.

As appropriate, the term “restriction approach” has been replaced by “regulatory risk management approach” throughout the document.

IPEN 7 Information provided by industry… It is not only based on information from industry stakeholders.

IPEN 7 Where does the request for these exemptions come from? I cannot find justification for them in this document or the EU assessment. Membranes for production processes is a wide undefined exemption proposal… the POPRC need to know what production processes and what industry are involved.This proposed exemption in the EU was not based on the same background information as the protective textiles but based on SEAC´s general statement that “SEAC does not have in depth information per article type but prefers to allow a longer implementation for certain article types where uses could be critical for the protection of human health and the environment, or for the safety of industrial processes.It should be noted that RAC did not propose this exemption.https://echa.europa.eu/documents/10162/2f0dfce0-3dcf-4398-8d6b-2e59c86446be

The exemption is based on the exemption granted under the EU restriction.According to ECHA 2015c “Some stakeholders requested a derogation for different kinds of technical textiles (other than textiles for the protection of workers health and safety), such as textiles used for breathable membrane systems, medical textiles, special fibres for exhaust air filters/exhaust gas cleaning, etc. In this wide category are also included certain technical textiles used in articles for consumers use, such as tents, automotive textiles (car capotes), awnings, tarpaulins, pergolas, sails, and canopies.”To be discussed at the POPRC meeting. Parties and observers are

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Response

Page 38 invited to provide relevant information.

IPEN 9 Where does the request for these exemptions come from? I cannot find justification for them in either this document or the EU assessment. Membranes for production processes is a wide undefined exemption proposal… the POPRC need to know what production processes and what industry are involved.

Same as above

IPEN 11 There is no justification in this document for requesting these wide dispersive exemptions.

Further information provided by IPEN relevant for the indicated uses will be included in the document. However, it is not possible in the last commenting round to simply delete entire or major parts of paras containing information from industry.Besides, all exemptions are now in square brackets, which mean they should still be discussed and agreed on.

IPEN 11 In most of the world, this opens the door to losing control of substances. This EU-centric document should have consideration for the rest of the world and the objectives of the treaty.

Could be discussed at the POPRC meeting

IPEN 11 As these exemptions are not decided they should be in square brackets as well.

Yes, square brackets included (whole para 11). All possible exemptions will be discussed at the POPRC meeting.

IPEN 34 Add “This includes avoiding the replacement of POPs with other hazardous chemicals and an explanation of why an exemption is technically or scientifically necessary and why potential alternatives are not technically or scientifically viable.”

Sentence has been included

IPEN 37 Not clear – concluded by whom? Later on in this paragraph it is still recommended to list PFOA in Annex C. Very confusing – rewording needed to make clear that while for this particular part, listing in Annex C may not be required, but is still required due to the unintentional formation of PFOA from inadequate incineration.

Para has been adjusted also based on other comments by Parties and observers. Additional information on listing under Annex C is now included in the RME.

IPEN 37 A fraction or range of fractions or percent should be stated here.

Sentence has been deleted also based on other comments received

IPEN 39 Not all stakeholders in the EU process indicated that exemptions are needed

True, but also not only “industry” stakeholders.

IPEN 40 Government regulators and scientific studies routinely measure concentrations far lower than these; the statement gives the impression that this cannot be achieved.

No. This statement says that the limit values take account of the capabilities of analytical methods (which should be lower than the limit values). Information on analytical methods is given in para 21.

IPEN 43 As this date is over, checking with Canada on progress would be very useful.

Possibly Canada can provide up-to-date information.Please note: Paras 41- 44 have been moved to the Background document.

IPEN 46 In the US State of Vermont, the health advisory level for PFOA in drinking water is 20 ppt. In the US State of New Jersey, the health advisory level for PFOA in drinking water is 40 ppt.

Additional information and references included to para 46

IPEN 49 Again checking with Canada would be useful as this date is well past

Information from Canada received and para adjusted accordingly.

IPEN 51 Providing the varying health based guidance levels would be of use here.

No further information available.

IPEN 53 Additional source provided Additional source included

IPEN 62 If this is the case why is an exemption being sought for The sentence states that for “most” of

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Response

photo imaging? the applications…As indicated later in the RME it is still needed for certain application. Again proposal is included in square brackets in the summary chapter, so it is still open for discussion

IPEN 64 By including ‘in a country’ the definition becomes ridiculously broad as alternatives may not currently be ‘in a country’. Alternatives only need to be available and accessible to countries.

Entire para has been adjusted also based on other comments received.“in a country” has been deleted.

IPEN 65 The fact that some industry members CURRENTLY use PFOA is not a justification for an exemption. More importantly as some companies DO NOT use PFOA that is an indication there are alternatives. The argument we only use a little is not acceptable for POPs that never break down.

Not possible to overwrite / delete entire sentences as this is contribution by other Parties and observers and/or taken from several literature studies. As this is the final draft, Parties and observers contributing to this chapter will not have opportunity to comment on it again.Again, this is a statement by industry. A possible exemption is proposed in square brackets, so still open for discussion.Industry should provide further (preferably quantitative information) in order to support their request for exemption.

IPEN 65 Tends to demonstrate - definitely a qualitative statement and not objective

Yes. Industry should provide further information and figures to support this statement.It is not possible to change this chapter substantially as proposed. Information has been summarized from a number of sources and several stakeholders already commented on this para.

IPEN 65 This is not a SC restriction exemption time option Yes, it is proposed by SEMI. Exact exemption time should be discussed and agreed on international level at POPRC.

IPEN 66 Redundant with information below.This is not a SC restriction exemption time option.

First three sentences of para 66 have been deleted.

IPEN 66 Tends to demonstrate - definitely a qualitative statement and not objective.This is just an industry self-interest bid and could be removed.

See aboveIn is not possible to change this chapter substantially as proposed. Information has been summarized from various sources and several stakeholders already commented on this para.

IPEN 67 If ‘the same’ applies for this broad group of proposed exemptions then far more detail needs to be given to explain why the same applies. Textiles for the protection of workers appear to have nothing to do with ‘membranes for production processes.’

It is stated that …Overall, it cannot be fully assessed whether an exemption is justified…Still to be discussed and industry should provide data to support their request for exemption.Sentence adjusted mainly as proposed.

IPEN 67 However, this proposed exemption in the EU was not based on the same background information as the protective textiles but based on SEAC´s general statement that“SEAC does not have in depth information per article type but prefers to allow a longer implementation period for certain article types where uses could be critical for the protection of human health and the

further information included as:According to IPEN, no industry requested it and the Committee admitted that it had no in-depth information on these uses, which argues against considering this use for a global exemption.

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Response

environment, or for the safety of industrial processes. “It should be noted that RAC did not propose this exemption.https://echa.europa.eu/documents/10162/2f0dfce0-3dcf-4398-8d6b-2e59c86446bePage 38

IPEN 69 6 years is not a consideration under the SC. This is a statement by European Apparel and Textile Confederation (EURATEX). Exact exemption time should be discussed and agreed on international level at POPRC.

IPEN 70 This section starts by describing process techniques then suddenly says that somehow justifies a global exemption for a term that is not defined. As written, not justified…

Again, this is a statement / opinion from Textil+Mode. We cannot simply delete this information.

IPEN 71 This paragraph does not make a convincing case that we should consider an exemption for the whole world because one EU company wants one.

Please consider this is again a summary of available information and not a conclusion or proposal. An exemption for printing inks is not proposed in the concluding chapter.

IPEN 71 It’s not according to IPEN it’s according to your own table 3 in this document.

Sentence has been deleted also based on other comments received.

IPEN 72 Several proposals to adjust the para… Minor adjustments taken into account and information included that Norway recently nominated PFHxS for listing in the Stockholm Convention.

IPEN 73 This is another example of the Eurocentric position of this document. Countries, particularly developing countries are unlikely to be able to fulfil “conditions in points (a) to (f) of Article 18(4) of the EU Regulation (EC) No 1907/2006” required by the EU for this exemption. The SC exemption is for a closed system site limited intermediate. Trucking intermediates from one facility to the next is not a closed system. This is a good illustration of how out of touch this document really is.

The conditions established under REACH are just an example how conditions for an exemption for transported isolated intermediates could be. The conditions under the SC should be established depending on the resources available in the countries.

IPEN 74 Several adjustments proposed in the text Wording slightly adjusted as proposedSeveral additional sentences included on PFOB and PFOI.And last sentence of para 74 has been deleted, based on other comments received.

IPEN 75 Justification for this claim is needed No further information provided. This is the opinion from the industry association. Further information and data would be needed for justification.

IPEN 76 Several adjustments proposed in the text Text adjusted as appropriate. Similar statements have not been adjusted further.

IPEN 79 Several adjustments proposed in the text Para partly adjusted as proposed.An additional statement has been included at the end of the para as: According to IPEN, an exemption would also result in ongoing PFOA releases to humans and the environment from production and use.

IPEN 80 “…but there are fluorine-free foam or other methods of extinguishment alternatives available fulfilling the requirements of efficiency for many areas of use in Class B fires.”

Additional information included

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Response

IPEN 81 Proposal to delete entire para 81The normal lifetime of firefighting foam varies considerable with temperature and storage conditions. 20 years is an inappropriate length of time for continued dispersive use of a POPs chemical, a use which has led to massive contamination of groundwater in many countries. Anyway, if the product is already in use it is not covered by the SC

This is an opinion by SEAC and we cannot simply delete the entire para.Additional statement has been included to the para.

IPEN 83 The drafters may find this hard to believe, but most of the world does not know what paragraph 4e is and it is not really relevant to the text anyway.

Cannot spell out everything. Information can be looked up in case readers are interested to know more.

IPEN 83 Please check with Norway to ensure this interpretation is correct.

The interpretation is correct.

IPEN 83 This is very misleading. Germany proposed a transitional period in REACH to ensure a removal of PFOA-containing firefighting foams instead of their continued usage until all foams are used up. It is not clear what is meant by “the effect of reducing emissions is rather low in this case”, as the use of firefighting foams has resulted in significant contamination globally.

This is exactly what Germany proposes for the RME. Please see Comment Germany on 2nd draft RME on para 69.

IPEN 84 Several additional references provided Several additional references included

IPEN 85 Products already in use are not affected by SC listing. This is scaremongering.

This sentence does not relate to articles already in use.

IPEN 87 Additional literature sources. Several additional sources included in para 87

IPEN 88 Several proposals for change regarding cost estimation It is information from ECHA. Not adjusted.

IPEN 90 This is an unsubstantiated generalisation in regards to costing and should be removed.

Yes, but it is also the only quantitative estimation we have in this regard. We cannot just simply delete it. Additional data should be provided from industry to support this estimation /statement.

IPEN 92 Sorry, this is a global process, not an EU one. Yes, but this is information from the EU and this is also indicated in the para.

IPEN 98, 99, 100

Move to para 90 and partly redundant with para 90 Para 98 is new information and relates to costs in GermanyPara 99 has been moved below para 90 and para 100 has been deleted as proposed

IPEN 106 Several adjustments proposed in the textReferences needed

Reference for the entire para is (ECHA 2015a) as indicatedAbbreviations spelled out as suggested

IPEN 107 This is covered in para 110 It is not exactly the same information. It is not possible to delete the sentence in para 107 as you also propose to delete entire para 110.

IPEN 115 IPEN did not actually conduct these studies.From the Madrid Statement: “While some shorter-chain fluorinated alternatives seem to be less bioaccumulative, they are still as environmentally persistent as long-chain substances or have persistent degradation products. Thus, a switch to short-chain and other fluorinated alternatives may not reduce the amounts of PFASs in the environment. In addition, because some of the shorter-chain PFASs are less effective, larger quantities may be needed to provide the same performance.” The Madrid Statement also urges to prevent replacement of PFOA and related compounds with other fluorinated alternatives

Additional information included as proposed and reference to the Madrid Statement made

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Response

in order to avoid long-term harm to human health and the environment.Blum et al. 2015. The Madrid Statement on Poly- and Perfluoroalkyl Substances (PFAs). Environmental Health Perspectives 123(5):A 107-111. http://dx.doi.org/10.1289/ehp.1509934

IPEN 122 Several adjustments proposed in the textAdditional literature sources included.

All adjustments and literature sources included as proposed.

IPEN 123 A large industry-denial paragraph designed to created doubt does not add to the RME and undermines the scientific seriousness of what the RME is supposed to be.

Para has been deleted

IPEN 124 If this industry federation is so concerned about lack of information, then why use PFOA or its fluorinated alternatives?

Sentence has been deleted

IPEN 129 Several adjustments proposed in the text Para has been adjusted as proposedRedundant information has been removed.

IPEN 131 We did not perform that study. Ok, literature source included

IPEN General (before 135)

It should be specified what standardized technical requirements must be fulfilled for the various uses, such as EN 1568 and similar, to be able to assess availability and feasibility of alternatives#

Yes, this should be discussed and decided on international level (e.g. at the POPRC meeting)

IPEN 140 and 141

None of these statements references technical requirements of the firefighting foams, which makes it impossible to assess alternatives

See above

IPEN 142 Redundant with information below Redundant information has been deleted.

IPEN 143 …there is a lack of publically available information on toxicity and POPs properties.

Sentence included at the end of para 143.

IPEN 144 Proposal to include additional information and literature sources

Additional information has been included. Name of the company has been removed.

IPEN 145 IPEN did not perform these studies. Literature sources included in para 145.

IPEN 148 Is this supposed to be infectious liquids? Yes, has been adjusted.

IPEN 149 The advantages of PFOA stated above Ok, para has been removed

IPEN 150 Several proposal for adjustment Proposals have been included as appropriate

IPEN 152 This is a very old reference considering the pace with which technology is developingThey said they were interested in a time-limited exemption.

True, newer information should be provided by industry.In the concluding chapter no exact indication will be made. If exemptions should be time-limited or not and the exact duration of exemptions should be discussed and agreed on at international level.

IPEN 152 Norway has acted on this concern by nominating PFHxS to the Stockholm Convention.

Information has been already included in the RMEFurther adjustments in the text included as proposed.

IPEN Table 4 High performance requirements (e.g. protective textiles for professional use)Manufacture of small number of remaining critical conventional photographic productsConstituent in process chemical formulations (e.g. for photolithographic applications.

Yes, further specification is required to decide if specific exemptions are justified.Industry should provide further data.This should be discussed and agreed on at international level.

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http://dx.doi.org/10.1289/ehp.1509934




Response

Should be specified further to determine if specific exemptions are justified

IPEN 157 Adjustments proposed in the text minor adjustment included

IPEN 161, 162 and 163

Proposal to delete paras 161, 162 and 163 para 163 has been deleted

IPEN 172 Several adjustments proposed in the text see previous comments to photo imaging

IPEN 172 Several adjustments proposed in the text see previous comments to semiconductors

IPEN 181 additional information proposed additional sentence included

IPEN 194 No information on the previous exemption has been provided therefore it should be removed

see comments already provided to membranes

IPEN 196 As stated previously other countries may not have effective controls on transport and storage for this exemption.

Please see response to comment 73.

IPEN 197 This is too much detail for the summary and is already included previously and could be deleted from here.Proposal to delete large parts of para 197

Para has been adjusted and shortened

IPEN 199 Several adjustments proposed in the text Most adjustments accepted

IPEN 200 Several adjustments proposed in the text It has already been stated that it should be further discussed, etc.

IPEN 201 Several adjustments proposed in the text Para mostly adjusted as proposed.Additional information included.Parts of the text already adjusted due to consideration of other comments.

IPEN 203 Several adjustments proposed in the text Should be discussed and agreed on at international level

IPEN 204 Change reference Reference changed

IPEN 211 Several adjustments proposed in the text Describes options for listing. Final decisions should be discussed and made on international level.

IPEN 215 (h) Proposal to exclude “photographic coating…” see above (everything in square brackets, so still open for discussion)

IPEN 215 (i) Proposal to exclude “transported isolated intermediates…”

see above (everything in square brackets, so still open for discussion)

SEMI General (Scope)

To prevent uncertainty and provide clear guidance, we recommend that the POPRC use the terms “semiconductors and related electronic devices including microelectronics, photovoltaics, solid state lighting, electronic display, electrical sensors, micro‐electrical mechanical systems, and flexible and hybrid electronics,“ in the RME, and that this terminology also be used in the actual text of the exemption to the PFOA amendment.

Text has been already amended to cover articles which contain semiconductors or compound semiconductors.According to updated information from the EU, a full derogation is granted for articles which contain semiconductors or compound semiconductors. Therefore, we do not see the need to include an exhaustive list of products in the Annex, as e.g. in 5 years there may be new products made from semiconductors that we do not even think of today. The "flexible hybrid electronics" are a good example; they did not exist 5 years ago.

SEMI General (maintenance, spare parts, etc.)

We appreciate that the draft RME acknowledges the need for an exemption for the production, use and trade of PFOA-containing maintenance, spare and replacement parts (“spare parts”). We write to clarify that the duration of this “spare parts” exemption should be longer than the separate exemption provided for the production of new

This should be further discussed and agreed on international level at the POPRC meeting.

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Response

equipment used to manufacture semiconductors and related infrastructure.To avoid these interruptions, we request a specific exemption under Annex B for spare parts with a longer duration than the 10 year exemption for equipment and related infrastructure. Given the expected service life of this sophisticated equipment, we believe an exemption for the production, trade and use of “legacy” parts for semiconductor manufacturing equipment, which may contain PFOA, should be allowed for a period of 30 years following the expiration of the exemption applicable to the production of semiconductor equipment.

SEMI General (photolithography applications)

We would like to reiterate our prior request that the RME reflect this specific exemption as an “Acceptable Purpose” exemption in Annex B. As we previously stated, “We support the recommendation from the POPRC for an exemption for photolithography process materials for semiconductor manufacturing. We believe that this exemption should take the form of an ‘Acceptable Purpose’ exemption [under Annex B]”

Noted. However, again no indication will be made in the RME. This should be further discussed and agreed on international level at the POPRC meeting.

SEMI General (PFOA-related substances)

The current definition in the Draft Risk Management Evaluation (Draft 3) would include molecules where the linking atom was not an oxygen molecule, and in cases where no linking molecule existed (a direct carbon-carbon bond between the Perfluorinated side chain moiety and the polymer backbone). Degradation studies do not exist for these other side chain configurations, although given the large electronegativity exerted on the end carbon atom of the C8 perfluorinated chain, the bond strength with the polymer backbone when directly attached to the polymer backbone would be expected to be stronger than the oxygen molecule in either an ether or ester configuration attachment.It is for this reason that SEMI proposes that the Draft RME (Draft 3), Page 5, Section 1.1, 17(c)(i) be modified to the following (revisions are noted in red text below with red arrows to make it clear what we are referring to): Polymers with ≥ C8 based perfluoroalkyl-oxy side chains;This is the terminology that supports the identified degradation mechanisms proposed by Washington, et.al. and does not go beyond where studies have not proven degradation occurs with other types of side chain moieties or configurations.

The proposed change is not considered relevant. The argument about bond strength does not justify the proposed change, as being “stronger” doesn’t mean “unbreakable” under natural conditions.

Semiconductor Industry Association (SIA)

General As the Review Committee is aware, on 13 June 2017 the European Commission published the final regulation on PFOA in the EU’s Official Journal.SIA supports the European regulation, and we call on the Review Committee to provide for similar exemptions in its work.

Final regulation on PFOA in the EU is considered for the final draft RME.

SIA General The third draft of the risk management evaluation includes proposed exemptions for semiconductor manufacturing and equipment consistent with the European regulation, although the draft is unclear whether these exemptions will be provided for under Annex A or Annex B, and whether these exemptions will be time limited or not. SIA calls on the Review Committee to provide for acceptable purpose exemptions under Annex B and to ensure that any time limitation provides sufficient time to allow for the industry to complete the complex and costly process of identifying, qualifying, and introducing into commercial use appropriate substitutes that meet the unique functional

This should be discussed on international level at the POPRC meeting.

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Response

and performance needs of the semiconductor industry. If a time limitation is included, we call on the Review Committee to provide a time limitation that meets the needs of the semiconductor industry and provides for the allowance for a renewal of this period as circumstances warrant.

SIA General (Scope)

SIA believes the Review Committee should consider revising the scope of the term “PFOA related compounds” in the third draft. We believe that, as currently defined, this term may result in an overly broad scope that includes some chemicals that do not degrade into PFOA.The third draft defines related compounds as “Polymers with ≥ C8 based perfluoroalkyl side chains” (Section 1.1, Item 17(c)(i)). As discussed in more detail in the comments submitted by Semiconductor Equipment and Materials International (SEMI), the degradation studies cited in the draft address side chain polymers degraded into PFOA by the linking oxygen molecule. The draft definition, however, would include molecules where the linking atom was not an oxygen molecule, even though degradation studies do not exist for these other side chain configurations. Accordingly, we agree with the suggestion by SEMI that the definition should be revised as follows: “Polymers with ≥ C8 based perfluoroalkyl-oxy side chains.” SIA endorses this portion of the SEMI comments.

See response to comment SEMI on PFOA related substances

POPRC member-1

General (data and understanding)

The current risk management evaluation contains a lot of statements. Some are more or less copies from the Convention text and can be removed. Others are made during the intersessional period by various stakeholders and parties. I would recommend being very critical on statements, as they do not add to the information needed by POPRC. Examples: para 38: the most cost-effective and practicable control measure for PFOA and PFOA-related compounds is the prohibition of all production, use, import and export, which is particularly relevant in developing and transition countries that lack adequate regulatory and enforcement infrastructure; para 58: applications which could result in environmental contamination should be minimized and ultimately discontinued; para 59: Concerning stockpiles of PFOA, an appropriate storage of PFOA wastes until the proper capacity is available for destruction is required to limit environmental impacts; and para 74: This issue should be closely examined before considering exemptions Of course, we all agree on what we should do, but such statements do not add much in understanding whether intended measures are feasible, to what extent Parties to the convention have applied and carried out such intentions and to what extent they are successful. See also para 63. Statements in the Risk Management Evaluation need underpinning by data or proper references where they can be checked, otherwise they should be removed as they do not add to the scientific information needed by POPRC for their recommendation to COP9. I would plea for more data and more experiences.Paragraph 187 states that “It is difficult to predict confidently which specific uses and related releases contribute most to the risk, especially as there is such a diverse range of potential sources, and detailed information about most of them is lacking”, whereas paragraph 188 list a lot of submitters of information. One way to increase understanding is to ask the industries

The document compiles the information provided by Parties and observers in order to establish a discussion basis for the POPRC. The drafter considers statements provided relevant information for the discussion. To the extent possible, statements should be supported by scientific data. We do hope that for/at the POPRC meeting further substantial information will be provided which enables a fact based discussion and decision.

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Response

who have submitted information whether they can indicate the amounts they are using annually. The dossier indicates that for the semiconductor industry in para 187, but such information from the other users would be very welcome to get an idea on the priorities. A subdivision in applications in industrial processes and in articles/products and in closed and open sources would also add to the understanding of possible sources. Such a division is easy to generate.

POPRC member-1

General (references)

One of the developments I notice in the current PFOA RME is that there are a lot of references to institutional reports (ECHA, EFSA, OECD, US EPA) instead of to original studies. In the case text handles on concentration, emissions, and other ‘scientific’ topics, I have a preference for original papers rather than institutional documents as these are peer-reviewed. In that case, I would recommend going back to the original references. If the text focusses on legislation, impact assessment and the evaluation of measures, I can imagine that institutional reports offer more information.For a matter of clarity, I would recommend the drafters to incorporate Helcom’s (2013) Palette of measures on cost-effective management options to reduce discharges, emissions, and losses of hazardous substances. The document contains twelve pages dedicated to PFCs among which PFOA.

The drafter agrees and intends to go back to original sources as far as appropriate. The RME contains a lot of references to original sources.

POPRC member-1

General (Scope)

Please replace Regulation in the text of this Risk Management Evaluation with EU REACH Regulation or EU Regulation. It should be clear about what we are talking and it should be clear that the aim of the document finally concerns a worldwide scope.Although the risk management evaluation has improved considerably since version 1, still a leap has to be made to lift it to a document that applies worldwide. One of the big errors in the risk management evaluation is that conclusions on risk-benefit and proportionality are generalized by extrapolation from one country to another or from one region to the whole world. An example can be found in para 67 where it is stated that “However, for textiles used in outdoor applications (e.g. awnings and outdoor furnishing, camping gear), alternatives are available and an exemption is not proportionate”. However, a measure can be proportionate in one region, whereas it definitely is not in another.Another example concerns the legislative measures. In para 196 the drafters state “Neither Norway nor Canada or the EU have specific exemptions on the production of short chain fluorinated alternatives in place. Therefore, an exemption for closed-system site-limited intermediates is not needed for substances listed under Annex A or B of the Stockholm Convention to allow such re-processing.” However, the European REACH regulation already has a lighter regime for intermediates and consequently an exemption is probably not needed under REACH. This does not mean that an exemption is not needed under the Stockholm Convention. I would recommend the drafters to consult REACH articles 17 and 18 and the ECHA guidance on Intermediates where specific conditions are specified for isolated intermediates. This may be the case for the other jurisdictions as well.And there are more examples where conclusions for Europe are put into a general context, where it should not happen. I hope the drafters will be keen on that and

Throughout the document it is intended to specifically refer to specific regulation and the scope of the information. The drafter agrees that considerations will be different from region to region and will also be different on a worldwide scale compared to a national scale. However it is virtually impossible to provide consistent information for the global scale. It is therefore necessary and can be appropriate to draw conclusions from one region for another one and the drafter information, assessments and considerations made in Norway, Canada, the EU or elsewhere can provide useful information for other regions and scales including a worldwide scope.However, we agree that a measure can be proportionate in one region, whereas it may not be in another. This is already mentioned in some places in the RME and can be discussed at the POPRC.

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Response

specify if conclusions are for the EU only.

POPRC member-1

General (Annex C and priority)

In contrast to the previous version of the risk management evaluation, the 3rd version proposes to list PFOA in annex C based on improper incineration at temperatures between 250 and 600 °C. This is based on the FOEN 2017 document submitted in May which also indicates the following: “Results from an industry-sponsored study suggested that waste incineration of fluoropolymers does not emit detectable levels of PFOA under conditions representative of typical municipal waste combustor operations in the US…(～1000 °C; Taylor, 2009). Similarly, no formation of PFOA was observed in the off-gases from the combustion of some polyester/cellulose fabric treated with one type of fluorotelomer-based acrylate polymers at 1000 °C (Yamada et al., 2005).”Yamada et al 2005 concludes that “The results demonstrate that the polyester/cellulose fabric treated with a fluorotelomer-based acrylic polymer is destroyed and no detectable amount of perfluorooctanoic acid (PFOA) is formed under typical municipal incineration conditions. Therefore, textiles and paper treated with such a fluorotelomer-based acrylic polymer disposed of in municipal waste and incinerated are expected to be destroyed and not be a significant source of PFOA in the environment. Thus, we may conclude that under proper circumstances, no PFOA is being formed in the incineration process.I do not think that our recommendations should be based on situations that do not represent the normal incineration practice without thinking on how to implement measures in these cases. Besides that, a cost effectiveness evaluation for this measure should be provided as the present data are not very convincing that we are dealing with a large scale problem.If I oversee the risk management evaluation for PFOA I see a persistent substance that is easily distributed through surface and groundwater and which may lead to long term effects. I also see a substance, or a group of substances, that is applied in a variety of applications, of which we do not have a proper overview in the sense of amounts and emissions. Knowing that would already be an important step forward. But then still questions remain such as “What should we do with legacy already applied? (think of fire-fighting foam and the Swiss exemption for PFOS, or the European derogation under REACH and if we are going to clean the installations what are the cost-benefits related to reducing the amounts that still stay in the installation after each cleaning round), What should we do with spare parts containing the substance? (Automotive), How should we treat speciality applications where low amounts are used in a process? (Such as in semiconductor industry) or in applications that will be phased out soon but are present in a limited number of equipment? (Photographic imaging), Should we be more strict to practicing sites compared to real-case situations? (Fire-fighting foam) and How should we deal with isolated intermediates? (Use in the production of fluortelomers). An important distinction is whether the nominated substances are applied in a controlled process, or in articles/products. I hope that POPRC will have a fruitful discussion and also address some of these questions for COP9.

Information related to a possible Annex C listing has been added to para 30 and to a number of new paras below para 45.Relevant parts of this newly added information was already available in FOEN, 2017. This information includes information on the unintentional formation of PFOA from inadequate incineration of fluoropolymers e.g. from MSWI with inappropriate incineration or open burning facilities moderate temperatures. Some recent studies qualitatively show that small, but measurable amounts of PFOA and a wide range of other PFCA homologues can be generated during the thermolysis of non-functionalized PTFE (Ellis et al., 2001, 2003; Schlummer, 2015) and functionalized PTFE (Feng et al., 2015) at temperatures between 250 °C and 600 °C.We may indeed conclude that under proper circumstances, no PFOA is being formed in the incineration process above 1000°C, however, it is currently unclear to what extent formation of PFOA may occur in municipal waste incinerators where (i) flue gases may reach temperatures of 850 °C or greater and may result in different degradation products (García et al., 2007); (ii) other substances coexist and may interfere with the thermolysis of fluoropolymers (e.g., thermolysis of PTFE is inhibited by a hydrogen or chlorine atmosphere in contrast to steam, oxygen or sulfur dioxide, which accelerate decomposition; Simon and Kaminsky, 1998). A recent study found PFOA in the flue gases from the incinerator of Harlingen, the Netherlands (Arkenbout, 2016).BAT and BEP as described in relevant documents are being applied for other unintentionally produced substances and PCDD/PCDF and will be effective to a certain extent for PFOA as well. Additional costs for implementation of measures to reduce releases of PFOA, enforcement and supervision are therefore considered low, as the control measures for other unintentional POPs are already applied.This and other relevant issues and questions noted by POPRC member-1 can be discussed at the POPRC meeting.

POPRC 12 An important message to generate in the executive It should be noted that, as a result of

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member-1 summary is captured in paragraph 33. Although the proposal comprise various PFAS substances (see para 17), para 33 indicates that the information in the present draft risk management evaluation does not explicitly cover long-chain PFASs so far. Thus, it is hard to evaluate the socio-economic consequences for these substances. This should get its place in the executive summary.

the production processes, fluorotelomer-based substances are always mixtures. Therefore the information provided in the present risk management evaluation covers to a certain extent (or completely) also long-chain PFAS. The following sentence has been added to para 31:“As a result of the existing production processes, fluorotelomer-based substances have been generally manufactured as mixtures of homologues with a range of perfluoroalkyl chain lengths (for examples, see DuPont (1998)), including those that have more than eight perfluorinated carbon atoms (commercial products containing primarily >99% of one individual homologue may exist; this requires additional purification processes). Therefore, the information provided in the present risk management evaluation covers to a certain extent also those fluorotelomer-based substances longer chain PFAS (longer than 8:2).”

POPRC member-1

General (section 1.5)

Propose to list the actions in a sequential order. Thus, start with USA, followed by Canada.

Not quite sure why the order should be changed and why start with USA. Several changes will be needed in the entire document to be consistent. Not edited

POPRC member-1

27(a) The usual term is consumer products, not consumer articles. Please, verify by typing both in Google.

“articles” according to REACH regulation

POPRC member-1

27(e) Please add the criterion in words for readability. Due to page limitations we cannot include all details. Further information on screening criteria can be found in the Canadian Env. Protection Act.

POPRC member-1

27(f) Is it still possible to produce and export? Perhaps the US can provide explanation on this question.

POPRC member-1

29 Add reference Please consider that we are in a summarising chapter. Reference already included (UNEP/POPS/POPRC.12/11/Add.2).

POPRC member-1

Table 3 What does – mean? May be replace by ‚up to‘ See also the other entries

Dates updated according to the published EU restriction.

POPRC member-1

33 Please add a reference A link to the current restriction proposal was added.

POPRC member-1

35(c) The only source I could find is in the risk profile.During solid waste management PFOA releases may result from incineration, landfilling and recycling (Yamada et al., 2005; Poulsen et al., 2005) and it is assumed that recycling of contaminated wastes contributes to environmental releases (ECHA, 2015a).Poulsen does not contain information on incineration, Yamada does. He and co-workers state in the summary of the article: The results demonstrate that the polyester/cellulose fabric treated with a fluorotelomer-based acrylic polymer is destroyed and no detectable amount of perfluorooctanoic acid (PFOA) is formed under typical municipal incineration conditions. Therefore, textiles and paper treated with such a

In para 30, the RME refers to FOEN, 2017. Now, further information (mostly already available in FOEN, 2017) related to a possible Annex C listing has been added to para 30 and to a number of new paras below para 45.

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fluorotelomer-based acrylic polymer disposed of in municipal waste and incinerated are expected to be destroyed and not be a significant source of PFOA in the environment.Opposite to statements made in this RME and no reason to add PFOA and related substances to annex C I believe. Are open for references that proof the release of PFOA by incineration.

POPRC member-1

36 This is very generic and appears in precisely similar words in the dicofol RME. I would propose to remove it.

Yes, this is a generic kind of “check list” of possible control measures under the SC. It is considered helpful for systematically identifying and evaluating possible control measures.

POPRC member-1

37 At least a proper reference is needed to confirm the formation of PFOA. Secondly, all BAT documents indicate that adequate incineration is needed in order to destroy POPs. It cannot be that we put PFOA in annex C because of inadequate incineration. Enforcement is in that case the proper measure.See also the remark to para 35.


POPRC member-1

38 Largely repetition of the convention text. Please delete. Furthermore, the statement in the first sentence needs a scientific proof. I do not think that has been provided in this document yet. If not, please skip the statement. See also my comment to paragraph 185.

First sentence deleted.The remaining para is mainly an IPEN statement that they consider a total ban the most cost-effective and practicable control measure (which is one option for the first control measure identified in para 36). Their statement is considered important input for the discussion of control measures.

POPRC member-1

40 Fraunhofer (2011). ‘REACH: Test of substances of very high concern to prepare Annex XV Dossiers using perfluorinated compounds as example’ provide LOQs for various PFCs in various matrices. For most of these an LOQ of (< 0.5 μg/kg is provided, which suggest that 25 ppb is not a very realistic amount.This is a policy document, not a scientific one; the Fraunhofer reference (2011) above indicates the scientific backing of much higher LOQs.These additions may be essential for a Scientific Committee such as POPRC. So I would plea to add them here.

Noted. However, the information from European Commission, 2017 is considered relevant.Information on quantification limits are given in para 21. The LOQ in Fraunhofer, 2011 refers only to the methods applied for that study.

POPRC member-1

41 Please for a matter of clarity, present it point by point. Due to limited space we have moved sections 41 – 44 to the background document.

POPRC member-1

42 Please for a matter of clarity, present it point by point. Due to limited space we have moved sections 41 – 44 to the background document.

POPRC member-1

45 Here, the drafters jump to conclusions. Socio-economic considerations will be different from region to region and will also be different on a worldwide scale compared to a national scale as provided here.

We agree that Socio-economic considerations will be different from region to region and will also be different on a worldwide scale compared to a national scale. However it is virtually impossible to provide consistent information for the global scale. It is therefore necessary and can be appropriate to draw conclusions from one region for another one and the drafter considers that socio-economic considerations made in Norway, Canada, the EU or elsewhere can give indications for other regions

32




Response

and scales.

POPRC member-1

46 Health Advisory Levels are no control measures.HAs serve as informal technical guidance to assist federal, state and local officials, as well as managers of public or community water systems in protecting public health. They are not regulations and should not be construed as legally enforceable federal standards.HAs may change as new information becomes available.Thus I would recommend to remove it here and to add information to fore last sentence in para 51 where the health based guidance are also mentioned.

This is not regulations only. The chapter contains regulatory but also e.g. voluntary approaches. Though HAs may not be legally enforceable they are considered relevant in the context of the control measure “establishment of thresholds or maximum residue limits in water, soil, sediment or food.” (see para 36).

POPRC member-1

49 The 2010 reduction target was met by all signatories and annual progress reports show that the 2015 target should also be met.This is already more than a year ago. Has it been met?

Yes, it has been met. Additional information received from Canada has been included in the RME.

POPRC member-1

50 This is what the Nordic Paper, producer of PFC free paper states about this level: The recommendations from Danish authorities on fluorine in wrapping paper for food contact, the limit value <0.35 μg F/dm² is according to us unrealistic. http://www.tielman.se/img/File/Statement%20Fluorochemicals%20feb2016.pdf

It is not clear whether you propose a change to the RME.

POPRC member-1

52 Is there an indication of the amount identified and the amount prioritized? Is there a time schedule?

No further details available. Possibly Norway can provide further details.

POPRC member-1

53 The commercial airports in Sweden have replaced PFAS containing AFFFs with non-fluorinated alternatives that are degraded to carbon dioxide and water when used (Comment IPEN, 2017 on 2nd draft RME).A literature reference confirming the statement would be welcomed.

We agree. Possibly IPEN can provide a reference.

POPRC member-1

55 There should be no permission of landfilling these wastes, unless leachate is properly treated.More information on leachates and the problems: http://www.crccare.com/files/dmfile/CRCCARETechReport38Part5_AssessmentmanagementandremediationforPFOSandPFOA_ManagementandAssessment2.pdfThe document also provides a summary of potential PFAS-contaminated water remediation options with pros and cons.

A reference to the report has been included in para 47

POPRC member-1

55 Article 3.6 of the Convention. Please delete. Sentence has been removed (link to Decision POPRC-6/2 is given).

POPRC member-1

55 This is more a political statement than science based text. Furthermore, it is already in the Convention text and we need not to repeat that here. Please, delete.Secondly, it is repeated in para 210

Sentence has been removed (link to Decision POPRC-6/2 is given).

POPRC member-1

58 Has concrete actions already been carried out? And if yes, what are the experiences?

Yes, the report contains further information on actions already taken and actions foreseen in the future (e.g. dialogue with companies with the aim of promoting voluntary substitution, development of action plan within the EU in cooperation with other member states).

POPRC member-1

60 Please add reference if available Edited

POPRC member-1

Section 2.2.1

In a 2008 report of the European Parliament PFOA and other PFCs are mentioned in relation to aluminium smelting and semiconductor industry. The previous one is completely lacking from this RME, but it would be good

EditedIn the study it is not specified which PFCs are used in aluminium industry

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Response

to dedicate at least a few sentences to the source.European Parliament, Policy DepartmentEconomic and Scientific Policy (2008). Impact assessment on priority substances in water.

and/or which PFCs are emitted.A sentence has been added to para 29

POPRC member-1

66 Statement is very general. Please be more specific. If it concerns the semiconductor industry and I see SEMI’s and SIAs requests for exemptions or even acceptable purposes above the two sentences here seems contradictory.

Yes. Statement has been deleted.

POPRC member-1

67 Please supply the data and underpinning for this statement. Now it is a statement without any argumentation.Be aware that proportionality cannot be extrapolated to worldwide scale.

No further data is available on this use.Sentence has been adjusted as proposed.

POPRC member-1

68 PFOA may occur as an impurity of the production of side-chain fluorinated polymers… Please add data and the source of this statement. If not available, please skip.

As already indicated, this is a statement provided by the Bavarian Textile and Apparel Association and South-Western Textile Association (VTB SWT).No further data included. VTB SWT is invited to supply additional data for discussions at the POPRC meeting.

POPRC member-1

68 However, according to IPEN, the PFOA amounts and manufacturing process and conditions in other countries and regions are not known and could be substantial, resulting in human exposure and environmental releases (comment IPEN 2017 on 1st draft RME).This is a very general statement and it would be good if supported by data.

Yes, it is a comment by IPEN. No further supporting data available. IPEN is invited to provide further data for discussions at international level.

POPRC member-1

69 This text is based on the EU proposal, please adapt to Stockholm Convention.

This is a comment by the European Apparel and Textile Confederation (EURATEX). No additional information on global perspective has been communicated. It can be discussed at the POPRC meeting what can be concluded for the global scale.

POPRC member-1

71 It is not clear where this statement is based on. Please add the statement from the companies involved for reference.

Sentence can be deleted. Statement from Canada remains which is similar.

POPRC member-1

73 Proposal to adjust para on “transported isolated intermediates”

Para 73 has been adjusted also according to comments from others

POPRC member-1

74 Please refer to the SAICM website, which indicate the need to raise awareness and to generate and share information. It does not contain any remark on exemptions.

First sentence relates to SAICM. Second sentence is a rather obvious comment made by IPEN on the first draft RME. IPEN comment deleted.

POPRC member-1

75 For understanding, it would be good if industry can indicate the amount used.

We agree, however, no further supporting data is available. I&P Europe is invited to provide further data for discussions at international level.

POPRC member-1

76 For sake of understanding, it would be good to check whether PFOA is used as a process aid, or if it appears in products.

PFOA-related substances are essential for the application of coating layers during the manufacture of some remaining conventional photographic products. Hence, it appears in products. The ability of PFOA-related substances to control surface tension is a critical aspect of the use of these materials as coating aids.

POPRC 79 Which committee EU scientific committees RAC and

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Response

member-1 SEAC

POPRC member-1

80 Please write out AFFF first time it is mentioned Already done in para 52.

POPRC member-1

80 Very good to start with a short explanation on AFFF.It is thought that PFOA may be present in fluortelomer AFFFs. For clarity it would be very good to indicate whether these are regarded as PFOA-related substances or not.

Edited

POPRC member-1

81 Very good to add some information on the shelf life of firefighting foams. Big question is of course whether we should remove them and to what concentration is feasible.Please indicate which paragraphs are handling on the European restriction

Edited

POPRC member-1

82 Can you explain why there is a 10 ppm limit whereas para 83 and Table 3 states that Canada has an exemption for AFFF? If you cannot explain, please delete.

Yes, the statement from IPEN has been removed as it is not clear where the value comes from.

POPRC member-1

83 Time-limited? EditedNo time limit (see Table 3)

POPRC member-1

84 Should be placed not under “Identification of critical uses”, but under the next paragraph “Costs and benefits”. Would be good if socio-economic data are added.

Has been moved before para 95 in section 2.2.2. In that section socio-economic data is given.

POPRC member-1

Section 2.2.2

For a matter of clarity, I would recommend the drafters to incorporate Helcom’s (2013) Palette of measures on cost-effective management options to reduce discharges, emissions, and losses of hazardous substances. The document contains twelve pages dedicated to PFCs among which PFOA.Page 11 of the document summarise a number of measures

A para on HELCOM 2013 has been inserted in the beginning of section 2.2.2

POPRC member-1

87 Those are all statements, not science. Please add proper references.

This is true; however, IPEN provides scientific information in various places of the document underpinning their statements. Of course, IPEN is invited to provide further specific data and references for discussions at the POPRC meeting to further support their statements.

POPRC member-1

88 For which applications or for all European applications. Edited.For EU applications as indicated in the para excluding photographic applications and semiconductors

POPRC member-1

88 The costs provided earlier in the paragraph consider substitution costs. These substitution costs, by nature, do not take into account the considerations IPEN provided in paragraph 87. This considerations come on the account of benefits of phasing out as provided in para 91. You cannot add them here at the cost side and then again in para 91. Please remove the sentence.

Sentence has been removed as proposed.

POPRC member-1

92 …within the EU Adjusted as proposed

POPRC member-1

93 Of what? The use of PFOA, the phasing out of PFOA or something else? Furthermore, I think that ‘Although’ is better in its place than ‘While’

Sentence has been adjusted.

POPRC member-1

94 Norway has chosen to phase out PFOA in consumer products, and not in other products such as AFFFs, medical devices and food packaging. I know that an impact assessment has been made by Norway. It would

Possibly Norway can provide information on their assessment regarding the effectiveness of phase out.

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Response

be good that add that information here and the considerations for the restriction.Phase out seems to be effective. Some more information on the phase out would be welcome.

POPRC member-1

95 Probably legacy articles and past use Probably legacy use of AFFFs; adjusted accordingly

POPRC member-1

96 Please add some more info on the cases: Firefighting + paper industry

Adjusted according to additional information provided by Germany

POPRC member-1

99 Is it possible to give some indications of the amounts used for this sector

No further supporting data is available. I&P Europe is invited to provide further data for discussions at the POPRC meeting

POPRC member-1

100 Is it possible to give some indications of the amounts used for the various applications, e.g. by FluoroCouncil?

No information available. FluoroCouncil is invited to provide further data for discussions at the POPRC meeting.

POPRC member-1

106 Please provide original references for this paragraph.Is this paragraph on PFOA or on C3 Dimer? This sentence is confusing “PFOA is as well very water soluble and log Koc values are also in the range of 1 to 2.1”Likely is not the proper word. See page 132 of the annex XV dossier on PFOA (ECHA, 2014); See also the DE + NL CORAP on C3 Dimer which speaks about suspected.

The reference is ECHA 2015a according to which the data were taken from the registration dossier (as indicated in para 106) for the C3 Dimer salt.The confusing sentence has been deleted.The para is on the C3 dimer salt (sentence adjusted).“Likely” is the wording from ECHA, 2015a. Not adjusted

POPRC member-1

107 …under the REACH regulation Has been included in the text

POPRC member-1

107 Is it not easier to write that base on EFSA documentation half-life of ADONA showed to be much shorter than for PFOA and what it means

Not edited

POPRC member-1

109 Please indicate it in days or in terms of the Stockholm Convention

Not edited. These details are accessible and should not be specified in the RME.According to REACH Annex XIII, a substance fulfils the persistence criterion (P) in any of the following situations:(a) the degradation half-life in marine water is higher than 60 days;(b) the degradation half-life in fresh or estuarine water is higher than 40 days;(c) the degradation half-life in marine sediment is higher than 180 days;(d) the degradation half-life in fresh or estuarine water sediment is higher than 120 days;(e) the degradation half-life in soil is higher than 120 days.

POPRC member-1

109 If it remains a PBT suspect, please add the data on which that is based.

Reference to section C.3.3 has been included

POPRC member-1

109 In that case there should be a proper reasoning and from the previous para I conclude that a lot of data are still lacking. So, the most essential sentence from this para is: On the basis of all available information a full PBT assessment with consideration of the knowledge from the

Yes. This statement is already made in this para.

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Response

PFOA-PBT assessment cannot be performed.

POPRC member-1

111 Please indicate the identity of this alternative. Is it one of the ones mentioned in the previous paragraphs?

In the source, the identity is not specified. Para 111 has been deleted based on a comment from Switzerland.

POPRC member-1

114 This information is not in Dow Corning 2007, please remove or add a proper reference

Reference added

POPRC member-1

115 Duplicates, please combine with para 122 Yes. Statement deleted in para 115.

POPRC member-1

117 Please check the original source Done

POPRC member-1

122 Please indicate which characteristics, no are mentioned in the sentence before.

Probably P, B, T and possibly LRT? Possibly IPEN can indicate this.

POPRC member-1

123 Should an evaluation of the alternatives already take place here? These two paragraphs 122 and 123 contradict each other and I think the drafters should point to that. The last sentence count for every alternative, not only for the ones mentioned here.

Edited

POPRC member-1

127 Contain? Edited

POPRC member-1

128 Text is lacking here. The original source indicates that siloxanes are intermediates for synthesis of silicone polymers used for textile impregnation. Thus, the siloxanes are not the alternatives, but intermediates.I would propose to focus on silicones. If the authors want to focus on siloxanes, and I suspect there may be political reasons to do so, make clear that siloxanes are intermediates to silicones and under what circumstances they are applied. However, in that case, there may also be reason to look at the production processes of all the other alternatives as well.

Edited.It is made clear that siloxanes are intermediates.

POPRC member-1

128 and 129

Please add referenceSee also https://outdoorindustry.org/pdf/FINAL_ZDHC_P05_DWR%20Research_Nov2012.pdfand http://www.europeanoutdoorgroup.com/files/DWR-Study_Alice_Davies__digital_.pdfsee also https://outdoorindustry.org/pdf/FINAL_ZDHC_P05_DWR%20Research_Nov2012.pdf

Edited

POPRC member-1

131 The information is 12-13 years old. Is an update possible?And if it is not applied yet, we may question feasibility, don’t we?

The drafter is not aware of up to date information.

POPRC member-1

Firefighting foams (135ff)

On basis of answers to question within Parliament the following answer was provided. PFOA is hardly found in extinguishing foams for industrial use in the Netherlands. Manufacturers that supply for the European market have, after the ban on PFOS, used other fluorine compounds that may break into PFOA in some cases. This leads to low concentrations of PFOA in these foams. According to a Dutch fire extinguishing agent, these types of foams are also phased out and chosen for fluorine compounds which cannot break into PFOA. There are still residual stocks available to users, but in newly sold resources, no PFOA will usually be present, as a pollutant from the production process.On the questions on alternatives:Yes there are alternatives, but not for all incident types. For the smaller fires and leaks it is clear that alternative

In this section is already substantial information demonstrating that alternatives are available. Do you propose to add the response to the question within the Parliament in the NL to the RME? Could be discussed at the POPRC meeting.

37

https://outdoorindustry.org/pdf/FINAL_ZDHC_P05_DWR%20Research_Nov2012.pdf

https://outdoorindustry.org/pdf/FINAL_ZDHC_P05_DWR%20Research_Nov2012.pdf




Response

foams work, but there is no real hardness that indicates that these foams also work in case of major oil fires and incidents in complex chemical industry environments.Additionally, the extinguishing foams that do not contain perfluorinated hydrocarbons are not equally friendly to humans and the environment because they work with other product groups to improve working conditions.As far as is known, PFOA is still present in limited amounts. Depending on local considerations, this is expected to be completed in a limited number of years.Questions will be answered later in June/July 2017.

POPRC member-1

137 It would be good to add the nuance in the Swedish Chemicals Agencies report in their section 6.2.3 and 8.1.3.3.6.2.3: Swedavia, which owns ten Swedish airports, including Arlanda and Landvetter, had previously used fluorine-based fire-fighting foams but in June 2011 switched to a fluorinefree alternative (see section 8.1.3.3).The Swedish Armed Forces began phasing out the use of perfluorinated substances in firefighting foam in Sweden in 2011 [according to Berglind et al. (2013)]. Nowadays the Swedish Armed Forces use fluorotelomer-based fire-fighting foam, i.e. the substance that is broken down to perfluorinated substances. (Swedish Chemicals Agency 2015a).8.1.3.3: According to some analyses fluorine-free fire-fighting foams may give less protection against re-ignition which means that the fire may flare up without warning (Fomtec 2015). There are operations whose standards are such that current fluorine-free fire-fighting foams are not acceptable alternatives. One example is the Swedish Armed Forces which, in the event of a fire, allows 90 seconds to reach the location and a maximum of 90 seconds to cool down the cockpit (Borgh 2014). According to the Swedish Armed Forces it is difficult to find fluorine-free alternatives which meet these safety requirements. However, fluorine-free detergent foam is used in training..

Edited

POPRC member-1

138 This para concerns the costs and thus does not belong to this chapter. Please move to the sections on costs and benefits.

This section discusses several aspects related to the suitability of alternatives. Costs are also a considerable aspect.

POPRC member-1

139 See also the last paragraph in Swedish Chemicals Agency 2015 section 8.1.3.3.

Edited

POPRC member-1

141 Please explain, because from the earlier sentences in this para I understand that they cannot fully replace fluor-containing foams in all conditions.

However, in practice they are introduced.

POPRC member-1

Paper and food packaging142ff

An excellent paper on grease resistant paper is written by Song & Rogas 2013, Approaching super-hydrophobicity from cellulosic materials: A Review. Nordic Pulp & Paper Research Journal Vol 28 no. 2/2013.The approaches used in recent years toward super-hydrophobicity of cellulosic materials can be classified into two categories, based on the generation of roughness:(1) Roughness offered by coating cellulosic substrates, which include:a) Chemical grafting to modify the surface chemistry and surface morphology of cellulosic fiber/surface simultaneously.

Do you propose an adjustment to the RME? Could be discussed at the POPRC meeting.

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Response

b) Sol-gel processes to render cellulose fiber/surface with porous outer-layer and to reduce surface energy by post-treatment or by mixing precursors with low surface energy side chains.c) Nanoparticle deposition, for example by using metal, metal oxide, mineral and polymers that modify the morphology of the cellulosic fiber/surface, followed by surface energy reduction by post-treatment.d) Chemical vapor deposition.I am curious to know what alternatives the non-fluorine alternatives could be categorised under. Is that another chemical treatment and if yes, with what chemicals and if no, can it be by nanoparticle deposition.

POPRC member-1

145 Please refer to the original documents: Norden 2013, SFT 2007 and Nordic Ecolabelling 2014.Nordic Paper seems to be the only producer.I do not think that we want paper being replaced by paper containing chromium or organotin compounds. See the following text from Nordic Ecolabeling (2014): The manufacture of grease-proof paper has slowed down in Europe, meaning that there is a risk of increased imports of paper containing organotin compounds.And: Coating agents containing chromium are used for e.g. baking paper.And: The paper can be surface treated using starch, alginates, CMC (carboxylmethylcellulose), chromium compounds, fluoride chemicals or silicone.How are we going to capture this in this document?http://www.miljodirektoratet.no/old/klif/publikasjoner/2354/ta2354.pdfhttp://www.svanemerket.no/PageFiles/1849/Background_document_049_4_0.pdfI think that here cost-benefit also comes in place and I have not seen a proper analysis of these considering this example. Why is it lacking? Why, if this paper is already on the market since 2006 it is not or to a limited extent exported to other European countries (SFT 2007, PFOA in Norway.)

We could not identify these original sources in (Swedish chemicals agency, 2015). The statement is correct according to the reference used.Could be discussed at the POPRC meeting.

POPRC member-1

Imaging and printing industry149ff

As for some other applications, refer to UNEP 2017 Edited

POPRC member-1

149 These sound like a lot of applications, a number of which have not been mentioned in the list of applications named in this RME. Would be worthwhile to request I&P on more detail or otherwise indicate that they will be prohibited. It may also be to invite I&P to POPRC.

These are rather multiple functions…PFOA-related substances are essential for the application of coating layers during the manufacture of some remaining conventional photographic products i.e. products in which the formation is based on silver halide technology.Further information is given in the Annex F submission by I&P but of course it would be good to further discuss with I&P on international level at POPRC.

POPRC member-1

151 This paragraph is on costs, please move to the appropriate section

Entire para has been deleted. Costs estimations made by I&P Europe are already presented in the cost section.

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Response

POPRC member-1

154 Duplicates second sentence of this para. Deleted

POPRC member-1

154 This does not appear earlier in the RME, please add reference.

The reference is German Environment Agency, 2016 (as indicated).

POPRC member-1

154 I think it is essential to get some insight in the available alternatives. See also the remarks on packaging application. I do not think we want chromium or organotins phased in as alternatives in a large part of the world. I have some doubts as well in the case of nano-particles.

We agree. Could be discussed at the POPRC meeting

POPRC member-1

157 Text: Continuous use and emissions may lead to rising concentrations in the environment and to long-term, large-scale exposure of humans and the environment to PFOA.Comment: This counteracts the statement made in para 94 on basis of the submission by Norway stating that the consumer products containing has decreased as well as the concentrations.See also Figure 3 in: http://www.naturvardsverket.se/Documents/publikationer6400/978-91-620-6513-3.pdf?pid=3822

In the drafters view there is no contradiction. In the case of continuous use and emission may lead to rising concentrations in the environment and to long-term, large-scale exposure of humans and the environment to PFOA (even though there may be decreasing trends in specific cases).

POPRC member-1

166 This is a very general statement, which is not the reality for quite a number of applications. I refer to the complicated replacement of AFFF and the cases on paper and packaging. Much more nuance is needed in para 166

“several” inserted in order to add nuance to this statement

POPRC member-1

167 Seehttps://echa.europa.eu/documents/10162/22816069/frans_oosterhuis_day3_presentation_en.pdf/0dc0ac12-c689-49d6-b6a8-e3f7eba3b30borhttps://echa.europa.eu/documents/10162/13647/R15_11_pbt_benchmark_report_en.pdforOosterhuis et al 2017 Towards a proportionality assessment of risk reduction measures aimed at restricting the use of persistent and bioaccumulative substanceshttp://onlinelibrary.wiley.com/doi/10.1002/ieam.1949/epdf

The following para has been inserted below para 167 based on source 3:“A benchmark study using cost-effectiveness analysis to assess the proportionality of measures to control PFOA (and other substances) looks at the cost-effectiveness estimates for regulatory measures that have been applied or considered for PFOA. Although the search and assessment presented in the study has an explicit global scope and all available studies, reports, and publications that could be found online were included, there may be a slight European oversampling “bias” due to the authors’ domicile and language coverage. The available evidence suggests that measures costing less than 1,000 €/kg substance use or emission reduction will usually not be rejected for reasons of disproportionate costs, whereas for measures with costs above 50,000 €/kg substance such a rejection is likely. The mean estimated unit costs for substitution, emission control and remediation costs for PFOA are 1,580 €/kg (range 28 to 3,281) (see Oosterhuis et al., 2017).”

POPRC member-1

167 Please more details, it is here rather vague what Norway is thinking of

Perhaps Norway, the US or the Netherland can add more details?

POPRC member-1

167 The nomination is handling on PFOA, not on PFAS. Necessary to be specific

As specified in the next sentence the PFAS compounds include PFOA even at elevated levels (PFOA concentration was exceeding the German limit value for drinking water for PFOA by

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Response

approx. a factor of 10)

POPRC member-1

167 And those specified in the Convention would be conducted?

Open question

POPRC member-1

168 Please add information on those compliance costs. It also contrasts the statements of IPEN in the previous paragraph.

There is no further information available to the drafter.

POPRC member-1

171 Please add data or reference where they can be found This is a comment provided by Norway to the first draft RME. No further information included.

POPRC member-1

174 Please add a proper reference Edited

POPRC member-1

176 Please add the argumentation or the data + a proper reference. This is only a statement.

As indicated, this is a statement made by IPEN. No reference available. Can be discussed at the POPRC meeting. IPEN is invited to provide data and references.

POPRC member-1

Section 2.5.2

Please restrict this chapter to regular monitoring activities, and not to individual studies. If I search SCOPUS database for the words PFOA and monitoring in title and abstract I find 507 hits in the last ten years comprising several dozens of Parties to the Convention. That indicates the interest in PFOA, but does not necessary indicate monitoring capacity.

Edited according to specific comments on this section

POPRC member-1

181 Are the data available and if so, where?Please remove or transfer last two sentences to another chapter. This information does not add to the status of control and monitoring capacity.

Edited (last two sentences deleted)

POPRC member-1

183 Please remove or transfer to another chapter. This information does not add to the status of control and monitoring capacity

Edited

POPRC member-1

185 Most effective way to what? To prevent that countries have to monitor production and use? If there is a prohibition they still have to monitor that, as it is an obligation under the convention.Besides, the task of this Risk Management Evaluation is more complicated and to balance various topics. I would ask the drafters to carefully read the chapeau of annex F, and consider what is requested there.

First part of the sentence deleted

POPRC member-1

187 I truly believe the statement of the drafter, as this RME concerns a complicated nomination. However, the sentence contrast with what is stated in paragraph 188 below

It is not clear with what this sentence contrasts. Could be discussed at the POPRC meeting.

POPRC member-1

187 In order to get an impression of the consequences of a possible listing in the Convention, amounts for the other applications would also be very welcome.

Parties and observers are invited to submit corresponding data

POPRC member-1

188 Annex E and annex F are mixed up here According to the request for information for PFOA Parties and observers were invited to submit Annex F information. The Annex F form includes Additional Annex E information. The additional Annex E information provided was included in the background document to the RME for information purposes. Annex F and E are not mixed up.

POPRC member-1

191 As it concerns inadequate management, I doubt whether we should list PFOA in annex C. Furthermore, an analysis of the cost effectiveness would be in its place, before adding to annex C. Such analysis on cost effectiveness has not been added in this Risk

Information related to a possible Annex C listing (including cost considerations) has been added to para 30 and to a number of new paras below

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Response

Management Evaluation. para 45.

POPRC member-1

196 European REACH regulation already has a lighter regime for intermediates. Thus, an exemption is probably not needed under REACH. This does not mean that an exemption is not needed under the Stockholm Convention.I would the drafters recommend to consult REACH articles 17 and 18 and the ECHA guidance on intermediates and specifically the part on isolated on-site intermediates. This may be the case for the other jurisdictions as well.

In this para we explain, that an exemption for closed-system site-limited intermediates is not needed for substances listed under Annex A or B of the Stockholm Convention to allow such re-processing since this exemption is already considered in the Convention text. We would suggest discussing this at the POPRC meeting.

POPRC member-1

197 Duplicates earlier text Yes, this section summarises risk management evaluation information

POPRC member-1

197 Annex E and annex F are mixed up here. This is considered Annex F information (positive and/or negative impacts on society)

POPRC member-1

197 Has there been a reach out to the pharmaceutical sector? The relevant industry has provided specific information. As a consequence a possible exemption is proposed (the use of PFOI for the production of PFOB for the purpose of producing pharmaceutical products). The pharmaceutical sector is invited to provide relevant information.

POPRC member-1

198 Please refer to the considerations in paragraph 76 and indicate a timeline.

We would suggest to discuss this at the POPRC meeting

POPRC member-1

199 Is the producer approached by the Convention?Realize that the Convention covers the whole world, not only the EU.

Parties and observers are invited to submit relevant information.

POPRC member-1

200 Does this mean that Aqueous firefighting foams with fluor are still allowed in Norway? See also Table 3

Yes, for professional use

POPRC member-1

200 Please indicate the life time of such foams under normal circumstances

Edited

POPRC member-1

202 Please see the comments earlier in the document on packaging

Do you propose a specific adjustment? Could be discussed at the POPRC meeting.

POPRC member-1

210 Within the medium-term, the POPRC recommends to carry out remediation activities in accordance with the “polluter-pays principle” with the aim to reduce risk.This is more a political statement than science based text. Furthermore, it is already in the Convention text and we need not to repeat that here. Please, delete.

Yes, has been deleted.

POPRC member-2

General The proposed exemptions are very broad. To facilitate POPRC discussions a more specific analysis and conclusion how to list PFOA and related substance would be useful.The document as it is written now is in some places a summary of statements and comments making it difficult for the reader what is the actual evaluation/assessment and conclusions (e.g. in section 2.2.1).

The document compiles the information provided in order to establish a discussion basis for the POPRC. Conclusions are made in section 3.2. on the basis of the information available. We do hope that the POPRC meeting will help the drafter to narrow further the scope of the exemption.

POPRC member-2

5 EU proposed restrictionComment: Please update in the whole document: the restriction is in the OJ, http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R1000

Edited

POPRC member-2

5 Suggestion to add:“…however it does not cover the degradation to PFOA from long-chain PFASs (perfluoroalkyl and

Edited

42

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R1000

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R1000




Response

polyfluoroalkyl substances)”

POPRC member-2

11 Please avoid the term “critical” as also proposed by other commentators on the second draft risk profile. Though an explanation is now provided in the body text the term is suggestive and should be avoided. Many RMEs were compiled without this terminology. Moreover Annex F does not require and foresee an evaluation of “critical” uses. The term is not used in the Convention at all. Though it was used in the RME for Endosulfan more recent RMEs did not contain this term. I strongly suggest reconsidering deletion of this term to the drafter; because I think more in-depth evaluation is needed to come up with “critical” uses in a global context and therefore I cannot support this wording.

EditedThe term “critical use” is now avoided. According to the context the word “critical” was sometimes deleted sometimes replaced by “certain”

or “specific” or “relevant” sometimes it is spelled out that we

mean “uses for which, there may not be accessible chemical and/or non-chemical alternatives in a country”

the title and first para of section 2.2.1 was adjusted

POPRC member-2

12 This para. is somehow isolated and should be substantiated with more information

Edited. The para is moved below para 9. Substantial information has been added to section 2.2.

POPRC member-2

17 Suggestion to delete “or” (three times) Edited

POPRC member-2

18 Please add in line with your answer to our comment on para. 28 of the 2nd draft risk profile) CAS 4151-50-2 (N-ethylperfluoro-1-octanesulphonamide, N-EtFOSA, SULFLURAMID) as PFOA-related compound and include information relevant to Annex F

EditedN-ethyl perfluorooctane sulphonamide can be degraded to PFOS and PFOA through photolysis, oxidation, and biotransformation (according to Liu et al., 2017 and references herein). It can therefore be considered both, a PFOS-related and a PFOA-related compound. Under the scope of the PFOA RME, PFOS, its salts and (PFOSF) as listed in Annex B to the Stockholm Convention is explicitly excluded. The substance which is proposed to be added is not covered by the current listing of PFOS, its salts and PFOSF in Annex B of the Convention. Therefore the substance has been added to the non-exhaustive list of substances.

POPRC member-2

30 Please include more information that is relevant for Annex C listing including peer-reviewed literature (e.g. Front. Environ. Sci. Engin. China 2009, 3(2): 129–151), source categories, available BAT/BEP, etc…The information presented now in the RME is too scarce to fully support Annex C listing

Para 30 has been extended and additional information was added to section 2.2 below (old) para 45.The study mentioned is a review of treatment technology of PFOA and PFOS in water. We do not consider it suitable for unintentional incineration here.

POPRC member-2

31 Text: “This goes beyond the EU restriction approach which does not cover the degradation to PFOA from long-chain PFASs.”Comment: Though improvements concerning this very important issue have been made I think that more information on how this may impact the proposed listing of PFOA and PFOA-related compounds under the Stockholm Convention is needed.

It should be noted that, as a result of the production processes, fluorotelomer-based substances are always mixtures. Therefore the information provided in the present risk management evaluation covers to a certain extent (or completely) also long-chain PFAS. The following sentence has been added to para 31:“As a result of the existing production processes, fluorotelomer-based substances have been generally manufactured as mixtures of homologues with a range of perfluoroalkyl chain lengths (for

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Response

examples, see DuPont (1998)), including those that have more than eight perfluorinated carbon atoms (commercial products containing primarily >99% of one individual homologue may exist; this requires additional purification processes). Therefore, the information provided in the present risk management evaluation covers to a certain extent also those fluorotelomer-based substances longer chain PFAS (longer than 8:2).”

POPRC member-2

36 Suggestion to add “thresholds” Edited

POPRC member-2

37 Please shorten this section in order to present more information on unintentional formation due to incineration that justifies listing in Annex C (see previous comment)

Edited (shortened)

POPRC member-2

41 to 44 Please shorten the following restriction/approaches from the EU, Canada and Norway, especially avoid a literally quotation of a complicated legislative text. The document as it reads now is already very lengthy, has many abbreviations and text passages that could be summarized more briefly. Please edit para 41-44 accordingly, and move the text as it is to the background document.

Edited.(Paras 41 to 44 are moved to the background document. Relevant information is already summarised in table 3. A reference to the background document is inserted in para 32.)

POPRC member-2

64 Please delete according to the previous comment. Edited (see response to comment on para 11)

POPRC member-2

188 The section should be dedicated to technical information, please delete to shorten the document.

Edited

POPRC member-2

200 Suggestion to adjust Edited

POPRC member-2

215(a) Please reword this use, a separation of time limited or not is needed. E.g. it is unclear why equipment used to manufacture should be without a time limit?

EditedSeparated into two separate exemptions: Equipment used to manufacture

semiconductors, their replacement and spare parts and related infrastructure (i.e. facilities-related chemical, gas, and air distribution and control systems and chemical container systems for storage, conveyance, and transport of substances or mixtures) and articles which contain semiconductors or compound semiconductor (time limited or not (Annex A or B));

Semiconductors or compound semiconductors (time limited or not (Annex A or B));

POPRC member-2

216 Please provide more information to substantiate the listing in Annex C.

Edited. See response to comment para 30

POPRC member-2

Background doc, Table 5

The Table would benefit from the addition of uses proposed for exemptions

Not edited.The Industry branches indicated in the first column differ from the proposed exemptions. Therefore it is not possible to match the proposed exemptions to this table.

POPRC member-2

Background doc,

Because para. 8 mentioned already that the information was mainly provided by IPEN the fourth column could

Edited

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Response

Table 6 be deleted.

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Table 2. Comments and responses relating to the second draft of the risk management evaluation on PFOA, its salts and PFOA-related compounds


Comments on the second draft of the risk management evaluation on PFOA, its salts and PFOA-related compounds

Response

Australia 44 For PFOS, PFOA and PFHxS, Australia has implemented precautionary health based guidance values, expressed as a tolerable daily intake (TDI), for use when investigating contaminated sites and conducting human health risk assessments

Additional statement has been included to para 44New source included to the list of references as (Australia Gov. 2016)

Australia 89 The Australian federal government is developing a whole-of-government response and also working in collaboration with Australian states and territories to manage and respond to PFAS contamination.

Statement has been included to para 89


The structure of the tables used to identify a non-exhaustive list of substances covered or not-covered by the risk management evaluation on PFOA, its salts and PFOA-related compounds are complex and difficult to reliably interpret. It is recommended that consideration be given to separating the information into a table of chemicals definitely within the scope of the chemical identity definition captured in the RME. It is recommended that a separate table of chemicals definitely not within scope be prepared to avoid confusion and to simplify the information presented.

The provided non-exhaustive list of substances is arranged in a way that corresponds to the categories of substances covered or not covered by the risk management evaluation as described in para 16 and that reflects different substance classes (e.g. perfluorocarboxylic acids, fluorotelomer iodides). The suggested approach of separating the information into tables of chemicals within/not within the scope would in the drafters´opinion not contribute to a simplification of the presented data and has thus not been edited.Please note that the category “others (depends on substance)” has been deleted in order to facilitate a reliable interpretation of the list of substances.


The OECD document, “ENV/JM/MONO(2006)15: Lists of PFOS, PFAS, PFOA, PFCA, Related compounds and chemicals that may degrade to PFCA” contains an important compilation of chemical identity information on more than 600 fluorinated organic chemicals including CAS RNs, chemical names and length of fully fluorinated carbon chain. Can the drafters please confirm whether this compilation was consulted for the compilation of the list of chemicals presented in this document? If this list has been consulted, it is recommended that a cross-reference be provided to the OECD analysis (which is attached).

The provided reference “ENV/JM/MONO(2006)15: Lists of PFOS, PFAS, PFOA, PFCA, Related compounds and chemicals that may degrade to PFCA” has not been consulted for the compilation of the non-exhaustive list of substances and thus no cross-reference is given in the RME.The provided OECD-reference does not specifically deal with PFOA, its salts, and PFOA-related compounds, but additionally includes many substances not within the scope of this RME. However, the approach of grouping substances in substance classes (e.g. perfluoro(alkyl) phosphonic and phosphinic acids, perfluoro(alkyl) carboxylic acids(compounds)) is comparable for the provided OECD-reference and PFOA INF, 2017b and many substances occur in both lists.Please also note that the definition of PFOA-related compounds is not identic for the provided OECD-reference and the RME.


The OECD document compiles fluorinated organic chemicals and provides the number of fluorinated carbon atoms for each substance (listed by CAS RN and chemical name). This allows cross-matching with the proposed chemical identity definition for PFOA-related substances

Please specify this comment. If desired, the lengths of fully fluorinated carbon chains can be considered for each entry of the non-exhaustive list of substances in the final draft of this

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Response

(taking into account the interpretation of the degradability pathway in terms of the scope of the proposed Stockholm listing).

RME.


The table contains a large amount of complex chemical identity information that can be difficult to rapidly check for accuracy. There are some quality assurance processes that can be performed on compilations of this type (such as CAS RN validity checks and cross-matching of chemical names) if such information is compiled electronically in the form of spreadsheets. If possible, we suggest that provision of the primary chemical identity data presented in these tables in a consolidated spreadsheet would be useful as it would allow such checks to be performed.

Please specify this comment. A consolidated spreadsheet (Excel-file?) of the non-exhaustive list of substances can be prepared for the final draft of this RME.


The attached paper (and its supporting information) “Perfluoroalkyl and Polyfluoroalkyl Substances in the Environment: Terminology, Classification, and Origins” by Buck et al (2011) provides an important primary reference on the complex nomenclature used to describe PFAS group substances, including PFOA-related substances. Are the drafters able to advise whether this paper has been drawn upon in compiling the information in these tables? If so, it is recommended to include a citation to this paper and its supporting material, which are both open access.

The provided paper by Buck et al., 2011 has not been drawn upon in compiling the information in the non-exhaustive list of substances and thus a citation to this paper has not been included in the RME.With respect to the nomenclature to describe PFAS, if possible, the CAS naming was uniformly applied in collaboration with ECHA.

Austria General From General Comments Austria (E-Mail 12.5.2017):Scope of the prohibition: It is not clear how the limit values such as proposed in

the opinions of ECHA’s scientific committees RAC and SEAC have been taken into consideration

As regards (time-limited) derogations, we recognise differences in the RME compared to the restriction scope as proposed in the draft European restriction proposal (available at http://ec.europa.eu/transparency/regcomitology/index.cfm?do=search.documentdetail&Dos_ID=13731&ds_id=47612&version=3&page=1 (e.g. uses such as latex printing inks, pulsed plasma nano-coatings, etc.); further reflections on why these differences have been introduced would add to the quality of the RME.

Comment 1: We agree that concentration limits such as proposed in the EU restriction proposal could be considered also under the SC. This should be discussed by the POPRC. The concentration limits in the EU restriction are mentioned and explained in para 36. In the case of PFOS listed under the SC, such concentration limits were not taken into account. In the case of SCCPs a concentration limit was not considered in the recommendation from the POPRC (UNEP/POPS/COP.8/14), however, a concentration limit of 1% was discussed and agreed at the COP8.See also comment Canada on para 199.Comment 2: Reflections on the differences are explained throughout the document and the conclusions on possible exemptions (which may differ from the EU proposal) are summarised in section 3.2

Austria 5 Suggestion to delete “general or other”Comment: Exemptions are specified in the following chapters; therefore deletion of “general and other” is suggested because it is very unspecific what is “general” and what “other” exemptions are.

Edited

Austria 5 Suggestion to replace “totally ban” by “restrict” Edited

Austria 6 Suggestion to add “and scientific committees concluded” Edited

Austria 6 Suggestion to replace “critical uses” by “specific uses”Comment: Please define “critical” or better replace or delete this term.

A new para has been inserted to explain the term critical uses in the beginning of section 2.2.1See also comment Switzerland on paras 61ff

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Response

Austria 8 Suggestion to delete “but global action is warranted”Comment: This is already stated in para.1

Edited

Austria 26 Suggestion to add “risk reduction approaches in countries including”

Edited

Austria 26a Suggestion to delete “Inclusion upon this list means the substances can be subject to further review and ultimately phased out under the Authorization process.”Comment: Can be deleted because the adequate control route for PFOA and PFOA-related substances in the EU is a restriction.

Edited

Austria 26b Suggestion to delete “After submission of the proposal to the European Chemicals Agency (ECHA) stakeholders delivered new information during the public consultation. Subsequently, the EU restriction proposal was updated including several proposals for derogation. These are further introduced in chapter 2.2.”Comment: Text could be more focused and shorten (page limit)

Edited

Austria 26g Please spell out abbreviations (here: PFAS) if used for the first time to enhance the readability for the reader.

Yes, for PFAS at its first occurrence in para 15

Austria 27 It would be beneficial to the reader to have an overview over the most important uses/emissions in the beginning of this section.

Edited. Paras 173 (on uses) and 174 (on releases) have been moved to the beginning of section 2.See also comment Belarus on chapter 2.

Austria 28 Suggestion to replace “Several legislative restriction approaches for PFOA and related compounds exist or are underway. It is important to note that these approaches…” by “National and regional control actions…”

Edited

Austria 28 Text: It is noteworthy, that PFOA-related compounds for the purposes of this risk management evaluation covers degradation to PFOA from long chain PFCsComment: Please include literature to illustrate the degradation

Information on the degradation of PFOA-related compounds is covered in the risk profile and the corresponding background document (see UNEP/POPS/POPRC.12/11/Add.2 and UNEP/POPS/POPRC.12/INF/5)Further, Section II of the additional information provided by Switzerland (FOEN, 2017) is related to the transformation/degradation of fluorotelomers to PFOA.

Austria 28 Text: This goes beyond the EU restriction approach which does not cover degradation to PFOA from longer chain PFCs.Comment: Please address this fact in more detail in Chapter 2.4. If an information gap remains this should be mentioned in the Synthesis Chapter as well

Comment noted. This will be addressed in the final draft

Austria 28 N-ethyl perfluorooctane sulponamide can also be transformed to PFOA (Li et al. 2017 and references herein) which might be a relevant emission source of PFOA to the environment. Please reflect and include this use as well since the substance is to my understanding not excluded from the scope.Li et al. (2017) Pollution pathways and release estimation of perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA) in central and eastern ChinaScience of the Total Environment 580 (2017) 1247–1256

Please specify this comment. N-ethyl perfluorooctane sulphonamide can be degraded to (PFOS and) PFOA through photolysis, oxidation, and biotransformation (according to Liu et al., 2017 and references herein), is therefore considered a PFOA-related compound for the purpose of this RME and thus included in the scope.

Austria 29 Comment: Please provide more details on the relevance of We agree more details on this would

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Response

long PFC for the PFOA RME. be beneficial and it is intended to include all relevant and available information. However, the document is particularly based on the information made available by parties and observers.

Austria 31, 32 Control measures in this context should focus on the measures that are achievable under the Convention.One option could be to change the order of para. 32 followed by 31 to keep the information.

Edited (order of paras 31 and 32 changed)

Austria 33 Suggestion to adjust text on SCCPs/MCCPsComment: Please note that SCCPs are impurities also in other commercial chlorinated paraffin mixtures.

Edited

Austria 34 The conclusion is made that “The most cost effective and practicable control measure for PFOA and PFOA-related compounds is the prohibition of all production, use, import and export.” Although we do agree that the prohibition of all production, use, import and export is an effective and practicable control measure for the substances under consideration, we do not see this conclusion, i.e. “most cost-effective”, being substantiated by any evidence. It is unclear on which criteria this conclusion is based (most-effective compared to what? To other risk management options? Etc.)

As indicated in the beginning of para 34, this para reflects the position of IPEN related to a prohibition of all production, use, import and export, i.e. without any exemptions.Paras 35 to 41 explain restriction approaches in the EU, Canada and Norway related to restrictions with exemptions which involved among other consideration on the efficacy and efficiency of the restrictions.In the process of developing these restrictions related to PFOA, its salts and PFOA-related compounds, technical and socio-economic information has been considered (also by scientific committees) as a decision basis to allow for general or specific exemptions from the restrictions. As a consequence the exemptions proposed or implemented give an indication for the identification of critical uses based on technical and socio-economic considerations. This is explained in para 42 and costs and benefits are further substantiated according to the information available in section 2.2.2.

Austria 36 Suggestion to delete para 36 Not edited. Para 36 is considered important information since it indicates that the EU restriction approach is considered by scientific committees the most appropriate measure. Moreover para 36 explains the limit values in the EU restriction approach.Note: para 36 has been adjusted according to a comment from Switzerland on this para in order to better explain the limit values.

Austria 37 Please summarize the EU restriction proposal or move it to the background document. It is not useful and unbalanced to literally quote the proposal. Also the details of the time limitation might more confusing since the final restriction is not published on the OJ yet.

It should be noted that not only the EU restriction proposal is part of the RME (see para 37) but also the approaches from Canada (see para 38) and Norway (see para 40).If it is decided to move the EU restriction proposal to the Background document, also the other proposals should be moved there.

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Response

See also comment AT on para 40All restriction proposals (i.e. paras 37, 38 and 40; also others) will be moved to the background document and reference will be made in the RME. This will be done in the final version of the report.

Austria 40, Table 3 This Table is a very good overview, however the national and regional control measures are now described in various para./pages. I would recommend to the drafter to further shorten the description of the national and regional control measures and move details of the text (but not the table.) to the background document.

See also comment on para 40

Austria 40, Table 3 Suggestion to replace “Restriction” by “Prohibition” Edited

Austria 40, Table 3 Text: Note: not relevant for this specific regulation in Norway since it concerns consumer products (and aqueous film-foaming firefighting foams are for professional use only)Comment: Could you enhance the clarity of the text? E.g. Not covered but exempted due to restriction of aqueous film-foaming firefighting foams for professional use only

Edited

Austria 43 Suggestion to delete last sentence Edited

Austria 43 Please add the Drinking Water Health Advisory value for PFOA of 70 ppt https://www.epa.gov/ground-water-and-drinking-water/drinking-water-health-advisories-pfoa-and-pfos

Edited

Austria 50 Text: Chemicals Inspectorate, the Swedish Civil Contingencies Agency (MSB) and the Environmental Protection Agency has produced a leaflet to the Swedish Rescue Services with recommendations to reduce the use of firefighting foam (Swedish Chemicals Agency, 2017).Comment: Please move to section 2.5.1

Edited. This information and corresponding information from Germany (see comment Switzerland on para 50) has been moved to section 2.5.1.

Austria 51 Text: Maximum residue limits in water are already recommended and applied by many companiesComment: It is not clear if these thresholds are voluntary limits or not and how they relate to the thresholds described in para 46 or 47. Please also note the work of Valsecchi et al. 2017Deriving environmental quality standards for perfluorooctanoic acid (PFOA) and related short chain perfluorinated alkyl acids, Journal of Hazardous Materials 323 (2017) 84–98

Yes, however this information provided by the textile and mode association is considered relevant.Guidance values e.g. in drinking water given in Valsecchi et al. are outdated (E.g. from US EPA, 2009). More up-to date values will be given in the final draft RME.

Austria 55 Please merge with para 50 and 55 Para 50 and 55 merged.

Austria 57 Text: Concerning stockpiles of PFOA, an appropriate storage of PFOA wastes until the proper capacity is available for destruction is required to limit environmental impacts (Canada, 2016a).Comment: And in place?

No. Canada stated in its Annex F submission (Canada, 2016a) that the temporary storage of PFOA wastes in an environmentally sound manner will be key in the RME to ensure environmental impacts are limited, until the proper capacity is available for the destruction.

Austria 57 Text: It is assumed that the degradation of fluorotelomer-based polymeric products represents a potential indirect source of PFCAs from degradation during use (e.g. sewage treatment plant sludge from laundering textiles) or disposal (e.g. landfill or incineration), (Prevedouros et al., 2006).Comment: Not clear how this is related to the efficacy and efficiency of possible control measures in meeting risk

This statement makes clear that WWTP and landfills should be appropriately managed in order to control this source.

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Response

reduction goals.

Austria 59 Technical guidelines on the environmentally sound management of wastes consisting of, containing or contaminated with perfluorooctane sulfonic acid (PFOS), its salts and perfluorooctane sulfonyl fluoride (PFOSF) under the Basel Convention might contain additional information on waste, if needed here.Please delete text part since it is a literally repetition of para 52

Edited. Repeated information deleted. Other information moved to para 52.

Austria 61 OECD Emissions Scenario DocumentComment: Could you please reference the OECD Document?

Reference added (OECD, 2010)

Austria 61 Text: The Public Consultations within the EU confirmed that the costs incurred would be high if this use was not derogated. Because of the low amounts used and the fact that emissions are expected to be low a time limited derogation (5 years after entry into force of the Regulation) for the equipment used to manufacture semiconductors is proposed in the EU restriction proposal.Comment: Does this also apply for the global situation? If not than this information gap should be highlighted.

Not edited. This applies for the EU situation and this becomes clear from the context.

Austria 61 Suggestion to replace “Besides” by “Therefore” Not edited. Here we are talking about an exemption for the equipment used to manufacture semiconductors and BESIDES for photo-lithography processes for semiconductors or in etching processes for compound semiconductors.

Austria 62 Text: In addition, SIA also requests that suppliers are provided with an acceptable purpose exemption under Annex B for its uses of PFOA and related compounds in manufacturing “tools” and ancillary equipment.Comment: It is not clear how this statement is connected to the first sentence of this para?

We agree. There is no relation. However, SIA request an acceptable purpose exemption under Annex B for its uses of PFOA and related compounds in manufacturing “tools” and ancillary equipment.

Austria 62 Text: In conclusion, SIA calls for an exemption under Annex B of the Convention for the industry’s uses of PFOA and related compounds in its manufacturing processes and the use of these chemicals in advanced manufacturing equipment (comment SIA 2017).Comment: I find it quite strange that the conclusion of this use is formulated by industry with a call for an exemption under Annex B. I would recommend to the drafter to redraft the conclusion.

Here the drafter analysis the information provided which can serve as the decision basis at the POPRC.Further information is particularly provided in paras 141 (alternatives) and 158 (economic aspects). The relevant information is summarized in para 181 including a conclusion from the drafter which can serve as a decision basis for the POPRC: “Time limited exemptions could be considered for equipment and related infrastructure used to manufacture semiconductors as well as for photo-lithography processes for semiconductors or in etching processes for compound semiconductors.”

Austria 62 Please include a short introduction what comprises technical textiles.

The following footnote has been added: “Technical textiles with high performance requirements means textiles such as textiles for the protection of workers from risks to their health and safety or textile membranes intended for use in medical textiles, filtration in water treatment or production processes and

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Response

effluent treatment.”

Austria 65 It seems that this is related to the upcoming EU restriction. Is this still relevant for a global control action? Transitional periods might be less relevant depending on when the Stockholm Convention control measure on PFOA will enter into force. Also e.g. competitiveness must then be seen on a global perspective.

We agree, however, the draft is based on information available and in the EU a time limited exemption is proposed (which is a relevant piece of information). As far as available also other (including global) information is considered and summarized in paras 182 and 183.

Austria 66 Text: As the technical textiles are produced in the EU, respecting the BEP, the amounts of emissions are close to zero. There are nearly no emissions, this also includes emission paths after production like domestic washing.Comment: Please present a more balanced global view. Are there additional sources to substantiate the industry claim that there no emissions?

Edited. It is already clear that the information is an industry statement. However, the text has been adjusted.

Austria 73 Suggestion to shorten para 73 Edited

Austria 75, 76 It would be more consistent to refer to the latest version of the EU restriction because the SEAC and RAC opinions differ from the actual proposal (European Commission, 2017) to enhance the clarity for the reader and to be in line with para 77.

The latest version of the EU restriction proposal is referred to in the document. Paras 75 and 76 intend to explain the process which lead to the actual proposal. They could be deleted in the final version.

Austria 77 Text: Germany proposes to include a transitional period for the use of the “old” foams, since the firefighting foams are very stable and may be stored for very long time until used in case of fire. Thus, the effect of reducing emissions is rather low in this case (comment Germany 2017).Comment: I also support a transitional period for “old foams” please see as example the PFOS in COMMISSION REGULATION (EU) No 757/2010

Edited

Austria 80 Text: Norway has an exemption in place for medical devices.Comment: Without a time limit?

Yes. Edited.

Austria 81ff Cost-benefit assessment (chapter 2.2.2, page 18): a monetised assessment of restricting the substances under consideration is available and included in the RME for the EU-wide approach which is currently discussed in the REACH committee. Overall, it would be beneficial if further monetised data (at least quantified data) are made available, i.e. for a broader perspective than the EU only in order to conclude on cost-effectiveness (as mentioned above).

The drafter agrees and would appreciate to obtain further monetised data that enable a broader perspective.

Austria 82 Text: The estimated substitution costs range from 1.39 to 158.44 million € with a 34.7 million € (central estimate; range from 1.39 to 158.44 million €) for the more realistic case (see ECHA, 2015a, Table F.2-6).Question: Median?Suggestion to delete repetition of the range

Answer: There is no median available. According to the reference “The central estimates could be considered as illustrating a more realistic scenario; however the information and data received by industry does not really allow identifying an ‘average’ case.”Repeated range deleted.

Austria 85 Suggestion to add “…and according to UNEP/POPS/POPRC.12/11/Add.2 PFOA is presumed to be an immune hazard to humans.”

Edited

Austria 86 Suggestion to delete the 2nd half of para 86: “…because, for the vast majority of uses, there are alternatives available that are implementable with a reasonable cost. Also, as imported articles and mixtures will also be covered by the restriction, the relocation of production

Deleted

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Response

facilities to outside the EU are is not a likely response by the industry concerned. Hence, it is not expected that there will be a significant loss (or gain) in employment in the EU due to the closing down and/or relocation of business activities”Comment: Details and text already given in section 2.4.6, please avoid repetition

Austria 90 Are there any cost estimated? Germany indicated that cost estimates could possibly be made available.

Austria 91 Please combine with para 92 Para 92 has been deleted according to a comment from Switzerland

Austria 96 1st sentence already stated in para 81 Deleted

Austria 97 Information on alternatives: in the relevant chapters of the RME (e.g. in paragraph 97) it is concluded that “For most uses of PFOA and PFOA-related substances alternatives exist”. Please note that in the opinions of ECHA’s scientific committees RAC and SEAC, extensive (time-limited) derogations are included as indeed uses have been identified, for which alternatives are not regarded being feasible and available to date. Although these derogations are mentioned in the RME, it is not clear how they are intended to be taken into account.

The opinions of the scientific committees as well as related derogations are considered in the RME in several sections. Considering also other information compiled in the RME, the information is synthesised in section 3.2 (including information on existing derogations) in order to come to a conclusion as a basis for discussion (on possible exemptions at SC level) at the POPRC meeting.

Austria 104 Suggestion to delete para 104Comment: Main finding is covered in para 104, not clear why only biodegradation is mentioned here? Other hazard endpoints are also important to consider and evaluate alternatives.

In para 103 6:2 FTOH is introduced as an alternative for fluorotelomer products based on 8:2 FTOH and extensive information on risks related to fluorotelomer-based short-chain chemistry including 6:2 FTOH is summarized in the background document of this RME (as described in para 105).However, in order to be connected with related information on biotransformation of 6:2 FTOH provided in the following para 106 the drafters suggest not delete para 104 (or move it to the background document of this RME).

Austria 107 Text: It is however admitted that toxicity thresholds are well above environmental concentrations and that they likely pose negligible risk to aquatic invertebrates (Mitchell et al., 2011).Comment: Please note that environmental concentration may change over time especially if used in higher amounts due to the phase out of PFOA and PFOA-related substances.

Edited (para has been complemented)

Austria 109 Suggestion to add “Nevertheless the alternatives and alternative mixtures may still exhibit hazardous characteristics that should be assessed before considering such substances to be suitable alternative.”

Edited

Austria 130 to 134 Please consider information given in the Guidance on best available techniques and best environmental practices for the use of perfluorooctane sulfonic acid (PFOS) and related chemicals listed under the Stockholm Convention on Persistent Organic Pollutantshttp://chm.pops.int/Implementation/NIPs/Guidance/GuidanceonBATBEPfortheuseofPFOS/tabid/3170/Default.aspx

Additional information with respect to fire-fighting foams has been added to the respective section and the provided reference has been included in the reference list.

Austria Section 2.3.3

This section is not consistent with the Table (technical or high performance textiles are missing)

The relevant paras 110, 111 and 112 have been moved to section 2.3.3

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Response

under the sub-section “Technical textiles with high performance requirements.

Austria 146 Suggestion to replace “PBT” by “POP” Edited

Austria 151 Text: The emissions from the small number of ongoing uses by the photo imaging industry have been assessed by a number of competent authorities in the EU, including the ECHA, and determined not to pose a relevant risk to the environment or human health.Question: Is this also applicable to a global situation?

There is no specific information available. However, according to (I&P Europe, 2016a) reductions in use of PFOA-related substances was worldwide by more than 95%. Hence it could be assumed that also globally there may be no relevant risk to the environment or human health (just an assumption).

Austria 151 Suggestion to delete “Further restrictions on the ongoing uses in the photo imaging sector, would not have relevant health or environmental benefits.”

Edited

Austria 153 Suggestion to adjust wording of first sentence Edited

Austria 159 While economic aspects are mentioned for textile and other uses no information is given on AFFF, which are considered very relevant in this section.

Economic aspects related to AFFF (high costs of remediation) are given in para 156.However we agree, that further data on other cost aspects e.g. on replacing and destroying stocks of AFFF containing PFOA and related compounds would be desirable. An idea on the dimension of such costs could possibly be withdrawn from information available for PFOS containing AFFF:“The cost of replacement and destruction of the PFOS currently found in fire-fighting foam stores in the European Union has been estimated at €6,000 per tonne, or about €700,000 in total. Replacing PFOS throughout Japan with alternatives in an environmentally appropriate way (including collection, refilling, transportation, storage and incineration) would cost ¥1.7 million (€13,000) per tonne, or ¥22 billion (€170 million) in total. In Canada, in 2006, disposal and replacement costs for PFOS-based fire-fighting foams were estimated to be Can$ 700,000 (€500,000).”“Some users say that the highest cost associated with the ban on PFOS-containing foams has been clean-up/destruction of the PFOS-containing foams and not the purchase of the new foams.”“A British survey states that the fluorine-free alternatives to fire-fighting foams in the United Kingdom are approximately 5–10% more expensive than fluorosurfactant-based foams. According to a manufacturer of fluorine-free alternatives, the price would fall if the market size increased. A more deliberate shift towards fluorine-free fire-fighting foam alternatives would probably eliminate

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the difference in cost.”(Source: POPRC.12/INF/15/Rev.1)This information is not specific to PFOA, its salts and related compounds. If, however considered appropriate, this information could be reflected in the draft RME on PFOA.

Austria 159 Text: According to industry representatives, a ban on fluorinated products leads to a substantial decline in economic and innovation power, which means that European textile companies lose their competitiveness (see VTB SWT, 2016; TM, 2016; Euratex, 2016).Comment: Please specify which fluorinated products is meant

Specification to C8-perfluorinated productsNote: Specification of fluorinated products in Annex F submissions:VTB SWT 2016: “C-8 chemistry”TM, 2016: “C-8 chemistry”EURATEX, 2016: “C8 Telomer chemistry”

Austria Section 2.5.2

In this section an overview on analytical challenges of PFOA and PFOA related substances in various matrices would be beneficial, also to highlight further research need.

Information on analytical standards including on challenges is given in the last para of section 1.1 on chemical identity (adjusted for the 3rd draft). If considered more appropriate, that para could be moved here.

Austria 172 Suggestion to delete para 172Comment: This information is already covered under section 1.2 (a).

Edited

Austria 183 Suggestion to delete “According to the information available for the analysis of alternatives,”

Edited

Austria 183 Text: There are also questions related to membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment.Comment: Which questions? Please specify

The sentence has been re-formulated

Belarus 26e the first sentence should be placed between the words … December 31, 2015 and Furthermore, in October 2016 (in accordance with chronological description)

Could you please specify your comment?

Belarus Chapter 2 The list of spheres or products of PFOA, its salts and PFOA-related compounds usage should be placed in the beginning of the chapter 2 (for better understanding what should be regulated).

Edited. The information contained in para 173 has been moved to para 27

Belarus Chapter 2.3.2

Production of fluoropolymers and fluoroelastomers should be placed in the beginning of the subchapter because it is still the main sphere of PFOA application.

Edited. Please note that the headline “Polymerization processing aid” has been changed to “Manufacture of fluoropolymers”.

Belarus Chapter 2.3.2

Considering the alternatives, the whole list of spheres or products of PFOA, its salts and PFOA-related compounds usage should be named: for example, paints, ski wax, non-stick coating, fluororubber, etc.

Section 2.3.2 only describes alternatives of PFOA, its salt and PFOA related compounds for uses or sectors where substantial information on alternatives is available. Uses/sectors where no specific information or reference on alternatives (fluorinated, non-fluorinated) is available (e.g. oil and mining production, personal care products/cosmetics, biocides/pesticides, skiwax) are, however summarized in INF/6/Add.1; Section 3 and a link is given in para 97.

Belarus Chapters The name of spheres or products of PFOA, its salts and Could you please specify your

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2.2.1 and 2.3.2

PFOA-related compounds uses should be highlighted in the text.

comment?

Canada General In addition, we have identified additional references that may be useful to the drafter

Comment noted.Please specify which statements of the provided references should be added to the final draft of the RME.Please note that, due to page limitations, only the most important issues should be considered.

Canada 5 Suggestion to better reflect Canadian regulations. Edited

Canada 14 Suggestion to adjust wording.Comment: Suggest that this paragraph clearly indicate that the RME focuses on the nominated substances, consistent with the risk profile, and that the INF documents are intended as guidance.

Edited

Canada 14 Please note that PFOA INF 2017b did not include all PFOA-related compounds that have been identified in the Canadian assessment. Canada has provided this information within the background document.

Comment noted

Canada 14 Please note that similar work to identify PFOA-related compounds was undertaken by the OECD (see reference below). A non-exhaustive list of PFOA, its salts and its related compounds was created and this information could be added to PFOA INF 2017b.Reference:OECD (2006), “Preliminary Lists of PFOS, PFAS, PFOA and Related Compounds and Chemicals that May Degrade to PFCA”, OECD Papers, Vol. 6/11 (pdf provided in the email)

The provided OECD-reference does not specifically deal with PFOA, its salts, and PFOA-related compounds, but additionally includes many substances not within the scope of this RME. However, the approach of grouping substances in substance classes (e.g. perfluoro(alkyl) phosphonic and phosphinic acids, perfluoro(alkyl) carboxylic acids(compounds)) is comparable for the provided OECD-reference and PFOA INF, 2017b and many substances occur in both lists.Please also see comment from Australia on PFOA INF, 2017b

Canada 33 Suggestion to better reflect Decision POPRC-12/3. Edited

Canada 39 Suggest improving accuracy since these substances have never been manufactured in Canada.

Edited

Canada 46 Suggest to better reflect wording contained in the reference (Canada, 2016c)

Edited

Canada 77 Suggest that the word “specific” not be used here to better reflect wording in Canadian regulations.

Edited

Canada 87 Text: While no quantitative analysis of benefits has been conducted, the amendments will protect the environment.Comment: Suggestion to improve clarity.

Edited

Canada 87 Text: A voluntary agreement was made as an early risk management action to encourage manufacturers to work towards eliminating these substances from the Canadian marketplaceComment: Canada suggest deleting as it is repetitive from text above and has no relevance to the cost benefit analysis.

Edited

Canada 153 Suggestion to improve clarity Edited (see comment from Austria on para 153)

Canada 167 Hyperlinks provided Edited

Canada 199 Text: The control measure “Prohibition or restriction of production, use, import and export” may be achieved under the Convention by listing in Annex A or B as

See response to general comment from Austria on concentration limits

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described in the concluding statement.Comment: Paragraph 33 states the need for controls to establish concentration limits for PFOA and PFOA-related compounds in manufacturing:“Concerns with respect to unintentional generation can be addressed by establishing appropriate concentration limits in the Annex A or B recommendation for PFOA and PFOA-related compounds in manufacturing.”Will this be included in the recommendation or included in the specific part of the Annex that details actions?Suggest that this be clarified and discussed in more detail within the body of the risk management evaluation.

Canada Background doc, Table 3

Regulations are Italicized in Canada Edited


Hyperlinks added Edited


Hyperlinks added Edited


Suggestion to add the following references to the section “PFHxS is found in the Arctic, including in wildlife and humans”:1. AMAP Assessment 2015: Human Health in the Arctic. Arctic Monitoring and Assessment Programme (AMAP), Oslo, Norway. Vii + 165 pp.;2. Berg, V., T.H. Nøst. S. Huber, C. Rylander, S. Hansen, A.S. Veyhe, O.M. Fuskevåg, J.Ø. Odland and T.M. Sandanger. 2014. Maternal serum concentrations of per- and polyfluoroalkyl substances and their predictors in years with reduced production and use. Environment International, 69:58-66;3. Nøst, T.H., R. Vestergren, V. Berg, E., Nieboer, J.Ø. Odland and T.M. Sandanger. 2014. Repeated measurements of per- and polyfluoroalkyl substances (PFAS) from 1979 to 2007 in males from northern Norway: Assessing time trends, compound correlations and relations to age/birth cohort. Environment International, 67:43-53;4. Bjermo, H., P.O. Darnerud, M. Pearson, H. Enghart Barbieri, A.K. Lindroos, C. Nälsén, C.H. Lindh, B.A.G. Jönsson and A. Glynn. 2013. Serum concentrations of perfluorinated alkyl acids and their associations with diet and personal characteristics among Swedish adults. Molecular Nutrition and Food Research, 57:2206-2215;5. Glynn, A., U. Berger, A. Bignert, S. Ullah, S. Lignell, M. Aune and P.O. Darnerud. 2011. Perfluoroalkyl substances in serum from first-time mothers in Uppsala – temporal trend 1996-2010. Report to the Swedish Environmental Protection Agency;6. Glynn, A., U. Berger, A. Bignert, S. Ullah, M. Aune, S. Lignell and P.O. Darnerud. 2012. Perfluorinated alkyl acids in blood serum from primiparous women in Sweden: serial sampling during pregnancy and nursing, and temporal trend 1996-2010. Environmental Science and Technology, 46:9071-9079.

1. The study has been added to the suggested section2. The study has been added to the suggested section3. The study has been added to the suggested section4. The study has already been used as a reference in section “PFHxS is transferred to infants during breast feeding, exposing the newborn infant” and has not been added again in the suggested section in order to avoid repetition5. The study has been added to the suggested section6. The study has been added to the suggested sectionThe list of references has been updated accordingly


Suggestion to add the following references to the section “PFHxS is widely found in children and adults, including in fluorochemical industry workers”:

1. The study has been added to the suggested section2. The study has been added to the

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1. Health Canada (2010). Report on Human Biomonitoring of Environmental Chemicals in Canada: Results of the Canadian Health Measures Survey Cycle 1 (2007-2009). Minister of Health, Ottawa, ON. Retrieved September 1, 2011.2. Health Canada (2013). Second Report on Human Biomonitoring of Environmental Chemicals in Canada: Results of the Canadian Health Measures Survey Cycle 2 (2009-2011). Minister of Health, Ottawa, ON. Retrieved May 30, 2013.

suggested section

The list of references has been updated accordingly


Suggestion to add the following reference to the section “PFHxA is also found in humans including in amniotic fluid and human milk and in higher concentrations in people with Gilbert Syndrome”:Health Canada (2013). Second Report on Human Biomonitoring of Environmental Chemicals in Canada: Results of the Canadian Health Measures Survey Cycle 2 (2009-2011). Minister of Health, Ottawa, ON. Retrieved May 30, 2013.

The study has been added to the suggested section


Suggestion to add the following reference to the section “PFBS contaminates drinking water and is found in humans, including in children”:Health Canada (2013). Second Report on Human Biomonitoring of Environmental Chemicals in Canada: Results of the Canadian Health Measures Survey Cycle 2 (2009-2011). Minister of Health, Ottawa, ON. Retrieved May 30, 2013.



Suggestion to add the following reference to the section “PFBA is found in humans, including in communities with known drinking water contamination.”Health Canada (2013). Second Report on Human Biomonitoring of Environmental Chemicals in Canada: Results of the Canadian Health Measures Survey Cycle 2 (2009-2011). Minister of Health, Ottawa, ON. Retrieved May 30, 2013.


Canada List of substances(related to comment on para 14)

We would like to point-out that regional differences could be observed in the list of CAS numbers found in PFOA INF, 2017b.Based on the Canadian assessment of PFOA, certain PFOA-related compounds included in the non-exhaustive list may not degrade to PFOA. It is important to note that degradation is often assessed using modelling, and depending on how the model conditions are defined and which model is used different results can be obtained. As such, caution should be used when identifying which PFOA-related compounds degrade to PFOA. Below is a list of CAS that may not degrade to PFOA and are included in PFOA INF, 2017b: 60699-51-6, 39239-77-5, 865-86-1, 93776-00-2, 307-50-6, 307-60-8, 307-63-1, 335-79-5, 376-04-5, 558-97-4, 3248-61-1, 3248-63-3, 307-43-7, 4980-53-4, 6014-75-1, 144031-01-6

Please refer to Section II of the additional information from Switzerland (FOEN, 2017) related to the transformation/degradation of fluorotelomers to PFOA.

Canada List of substances

Suggest to add the following compounds as they are identified in the Canadian screening assessment of perfluorooctanoic acid, its salts, and its precursors (reference below): CAS 45285-51-6, 90480-55-0, 90480-56-1, 53515-73-4, 68187-42-8, 65530-57-6, 65530-62-3, 65530-61-2, 70969-47-0, 82199-07-3, 95370-51-7, 148240-85-1, 148240-87-3, 148240-89-5, 183146-60-3, 80010-37-3, 71608-61-2Canada. 2012. Department of the Environment and Department of Health. Screening Assessment Report – Perfluorooctanoic Acid, its Salts and its Precursors.

The substances with the CAS No 45285-51-6, 90480-55-0, 90480-56-1, 53515-73-4, 70969-47-0, 148240-87-3, 183146-60-3 and 116984-14-6 have been added as suggested. Other than suggested the substance with the CAS No 68187-42-8 has been assigned to the category (c) (ii) since it is not a polymer but contains 8:2 fluorotelomer propanamide as one of the constituents. Other than suggested,

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Response

August 2012Available at:https://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=370AB133-1#a1

the substance with the CAS No 95370-51-7 has been assigned to the category (c)(other) since it has one constituent that has 7 fluorinated carbons and can degrade to PFOA. Other than suggested, the substance with the CAS No 148240-85-1 has been assigned to the category (c)(ii) since it is not a polymer but contains 8:2 fluorotelomer thiol as one as one of the constituents. Other than suggested, the substance with the CAS No 148240-89-5 has been assigned to the categories (c)(ii)(iii)(other) since it is not a polymer but contains 8:2 (ii), 10:2 (iii) and 12:2 (other) fluorotelomer thiol as some of the constituents. Other than suggested, the substance with the CAS No 71608-61-2 has been assigned to the categories (c)(ii)(iii)(other) since it is not a polymer but contains 8:2 (ii), 10:2 (iii) and 12:2 (other) fluorotelomer thiol as some of the constituents. The substances with the CAS No 65530-57-6, 65530-62-3, 65530-61-2 and 80010-37-3 have not been added to the non-exhaustive list of substances since it is very unclear whether these substances are functionalized PTFE or fluorotelomer-based substances. The substance with the CAS NO 82199-07-3 has not been added since it outside the scope (it has only 6 fluorinated carbon atoms).

Colombia 168 to 171 Respecto al PFOA se presenta la dificultad que tienen otros países con condiciones similares a las de Colombia para identificar los artículos o residuos que pueden contener estas sustancias, así como para monitorearlas e identificarlas en las diferentes matrices ambientales.(Unofficial translation: For Colombia and other countries with similar conditions it is difficult to identify products and wastes that may contain PFOA, its salts and related compounds, as well as to monitor and identify them in the different environmental matrices.)En consecuencia, se sugiere que en el numeral, 2.5.2 Status of control and monitoring capacity, se indique que muchos países no tienen la capacidad para determinar los artículos y residuos que contienen estas sustancias, así como para identificar su presencia en diferentes matrices ambientales, aspecto que en el momento de cumplir con las obligaciones que establece el Convenio se convierte en un obstáculo para realizar inventarios, identificar los residuos y adelantar los respectivos monitoreos; por esta razón se recomienda realizar proyectos piloto que permitan establecer la viabilidad de que los países cumplan y las medidas que se deben tomar para lograr el efectivo cumplimiento.(Inofficial translation: Consequently, it is suggested that in section 2.5.2, it should be noted that many countries do not have the capacity to determine the products and wastes containing these substances, as well as to identify their presence in different environmental matrices. This needs to be considered regarding the compliance with the

Edited (new para below para 170)

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obligations established by the Convention because such lack of capacity prevents to establish inventories, to identify relevant wastes and to carry out the respective monitoring. For this reason it is recommended to carry out pilot projects that allow demonstrating which measures should be taken to achieve effective compliance.)

Colombia 155 to 161 Considerando lo anterior, en el numeral 2.4.4 Economic aspects, se debe incluir que no se ha adelantado una valoración técnica y económica que establezca si países como los de América Latina y el Caribe o de África, cuentan con la capacidad para cumplir con las obligaciones que se derivan de incluir estas sustancias en alguno de los anexos de la Convención, así como con los recursos financieros para adelantar inventarios, realizar monitoreos, y de ser necesario eliminar las sustancias o los residuos que las contengan.(Unofficial translation: Considering the above, in section 2.4.4 (Economic aspects), it should be included that a technical and economic assessment has not been made to establish whether countries such as those in Latin America and the Caribbean or in Africa have the capacity to comply with Obligations arising from including these substances in any of the Annexes to the Convention, as well as the financial resources to carry out inventories, carry out monitoring, and eliminate the substances or wastes containing them.)

Edited (new para below para 157)

Germany 45 The document is still full of abbreviations, thus as mentioned already by others, the document may be difficult to read by non-PFAS-experts. HBM-I- value should be explained, because it may not be known to anyone, what it means. Suggestion:“The German commission on human biomonitoring has defined plasma concentrations of PFOA and PFOS below which, adverse health effects are not expected and therefore, no exposure reduction measures are necessary (HBM-I values)”

The term “HBM-I value is already explained in footnote 13 to para 45: “HBM I value represents the concentration of a substance in a body matrix below which, according to the Commission’s current assessment, adverse health effects are not expected and therefore, no exposure reduction measures are necessary.”Acronyms are explained in the Background document section 1 (List of Acronyms)Other Abbreviations (e.g. of industry associations) are explained at its first occurrence in the text.

Germany 51 This statement is confusing, since the DETOX campaign does not only apply to Germany. It should either be rephrased or even deleted.

Edited (“In Germany” deleted)

Germany 71 Although it is a statement of I&P Europe, it might rather be confusing to state here that some EU-countries might not be able to comply with the foreseen EU-restriction. Therefore, we suggest deleting this part of the statement.

Edited (“countries and in certain EU countries in the medical area such as Italy, Spain, Portugal, Greece and a number of Eastern European countries” deleted.)

Germany 74 There are again a number of new abbreviations in this para. It helps to know what SEMI stands for. What is ICT-industry?

SEMI stands for “a global industry association serving the manufacturing supply chain for the micro- and nano-electronics industries”, now explained at its first occurrence in para 62ICT is “Information and Communications Technology” (see list of acronyms in the background document)

Germany 75 In the beginning of the para it should be noted that the following information belongs to the restriction process in the EU. Otherwise it might be difficult to understand. SEAC should be explained.

EditedRAC and SEAC are explained at its first occurrence in para 36

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Germany 90 please rephrase to:“In Germany, there are two very prominent cases showing the consequences of (illegal) disposal of waste/sludge on agricultural fields (disposal of sludge from paper industry: see Skutlarek et al. 2006, Wilhelm et al. 2009, Wilhelm et al. 2010, Hölzer et al. 2008 Hölzer et al. 2009; and…a 400 ha contamination of agricultural fields with PFAS including PFOA most probably from sludge from paper industry into compost. PFAS were found in elevated concentrations in soil and groundwater. Two drinking water wells were closed. However PFOA and related substances are not the predominant chemicals found, indeed, short-chain PFAS are the main contaminants in this area. Crops show elevated levels of short-chain PFAS and cannot be consumed by humans or used as feed.) The overall consequences for the inhabitants, the public and the farmers are immense. The costs for remediation and water purification are high.”Perhaps it would be useful also to refer to the contamination of lakes, soil and groundwater by use of fire-fighting foam. The costs for the society (cleaning, loss of recreational areas…) are high (some data could be provided).

Para 90 adjusted as follows:“In Germany, there are two very prominent cases showing the consequences of (illegal) disposal of waste/sludge on agricultural fields. First the disposal of sludge from paper industry (see Skutlarek et al. 2006, Wilhelm et al. 2009, Wilhelm et al. 2010, Hölzer et al. 2008, Hölzer et al. 2009) and second, a 400 ha contamination of agricultural fields from sludge from paper industry into compost. PFAS were found in elevated concentrations in soil and groundwater. Two drinking water wells were closed. However PFOA and related substances are not the predominant chemicals found, indeed, short-chain PFAS are the main contaminants in this area. Crops show elevated levels of short-chain PFAS and cannot be consumed by humans or used as feed. The overall consequences for the inhabitants, the public and the farmers are immense. The costs for remediation and water purification are high.b (Comment Germany 2017).”Remark: It is questionable whether the second case is fully relevant the RME since “short-chain PFAS are the main contaminants”. Germany states that some cost data could be provided. However, these would particularly reflect costs for short-chain PFAS since these are the main contaminants. This is why cost data are possibly not fully relevant to the RME.See also comment Austria on para 90 asking whether there are any costs estimated.

Germany 100 Para 100: please use either short-chain or shorter-chain and do not use both terms in the document, for a better clarity. Moreover, we believe it would be sufficient to say that “short-chain per- and polyfluorinated substance replacing…” This is maybe easier to read.

Edited also in other places of the document

Germany 101 and following

Para 101 and probably in the following paras as well: try to uses easier terms: maybe rephrase for a better clarity: “With regards to perfluorinated compounds with shorter alkyl chain length…” to “With regard to short-chain per- and polyfluorinated…The para ends with …raise concerns, but the concerns are not explained. Maybe exchange para 102 and 101 for a better flow of information. Actually, the paragraphs in the whole section (short – chain fluorinated alternatives) should be ordered differently, try to describe the uses first (with advantages and disadvantages and costs) and then describe the concerns (persistence, mobility, uptake by plants, …)

Terms have been adjusted according to several comments received.

b To date there is no scientific paper available, but some information is provided by the local authorities (in German see http://www.landkreis-rastatt.de/,Lde/PFC.html and http://www.baden-baden.de/stadtportrait/aktuelles/themen/pfc-problematik/.

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http://www.landkreis-rastatt.de/,Lde/PFC.html




Response

Germany 105 Deleting “fluorotelomer-based” would still be correct, but easier to read.

Edited

Germany 125 Para 125; somewhere the whole list of alternative polymerisation aids (as far as they are known) should be included. Please consider also to include CAS-numbers. The alternative polymerisation aids were described by Wang et al., 2015.

A new para based on Wang et al., 2013 below para 124 describing alternative polymerization processing aids (including CAS-numbers) has been added.

Germany 129 Please explain PPA? PPA = polmerisation processing aid (explained at its first occurrence and in the list of acronyms in the background document)

Germany 130 Fire-fighting foams: this should be more developed. In the EU, fire-fighting foams are mainly based on C6-chemistry, containing residual PFOA and PFOA-related substances. It should be noted that for most fires, it is not necessary to use the so called aqueous fire-fighting foam (AFFF) which contains PFAS. Only for special liquid fires (e.g. in refineries) they may be used until relevant alternatives are available.

Edited. More information has been included in a new para above para 75, reference is made to the PFOS guidance: UNEP/POPS/POPRC.12/INF/15/Rev.:“AFFF is a generic term for firefighting and/or vapor suppression products used globally to extinguish fires. AFFF were designed to be especially effective in extinguishing Class B (flammable liquids) fires. AFFF are unique amongst other firefighting foams in that they contain a small percentage of fluorinated surfactant. Not every situation will necessarily require the use of fire-fighting foams. Only a careful consideration of the specific situation at hand (emergency incident or design of fire/property protection system) and review of local building codes and other regulations can determine the proper product selection. Over the past decade, AFFF manufacturers have been replacing PFOS based products with fluorotelomer-based fluorosurfactants. Today most fire-fighting foams are manufactured with fluorochemicals/telomers based on a perfluorohexane (C6) chain (further details see POPRC.12/INF/15/Rev.1).”

Germany 131 It would be worthwhile to explain what Class A and class B fires are or try to avoid these terms.

Edited. Class A fires are explained in the new para above para 75. Class B fires are not relevant.

Germany 134 Please try not to include only the opinion of one side of the manufacturers and users of fire-fighting foam. Manufacturers of fluorine-free foam will most probably show different results. I think in this document it is not possible to try to compare the performance of the fire-fighting foams. Several airports have already switched to fluorine-free foam. We are certain that they have tested the products very well in advance. The use of fluorine-free foams vs. AFFF-foams is a mine field. Maybe we should really concretely define in this document for which fires AFFF may be considered at all, to minimize the overall emissions of PFOA and related substances.

Para 134 has been complemented as follows (see also comment Norway on para 134:“However, fluorine free foams certified to different ICAO levels (required for use at civilian airports) are available on the market (see FFFP, 2017) and are already introduced at airports in practice (see above).”

Germany 136 The trade name and the name of a manufacturer should not be used in this document, since there are multiple products on the market.

Edited

Germany 143 Please include also the mobility and uptake by plants as properties for short chain PFAS. One additional point is that short-chain PFAS cannot be removed easily from

Edited; para 143 has been complemented with the following

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water bodies. Since they hardly sorb to surfaces, activated char coal is usually ineffective and to date no effective method is available.

information:Short-chain PFASs are highly mobile in different environmental compartments. The higher solubility in water compared to long-chain PFASs with more hydrophobic alkyl chains also contributes to the fact that short-chain PFASs do enter drinking water reservoirs faster and tend to accumulate in water-rich edible plant tissues like e.g. leaves and fruits. The presence in groundwater and drinking water might lead to a continuous exposure of organisms to short-chain PFASs, currently still at a relatively low level, but given the high persistence and the increasing use of these substances a temporal increase in environmental concentrations is assumed. This is even more valid as removal of short-chain PFASs from water cannot be performed effectively, not even with modern expensive technologies (e.g. using granular activated carbon or nanofiltration), due their low adsorption potential (see German Environment Agency, 2016b).

Germany 185 First line: add at the end of the sentence: and PFOA-related substances.

Edited

Japan General For the purpose of risk management, the present definition of “PFOA-related compounds” may not be workable. The definition should have criterion of degradation to PFOA, which should be supported by an integrated approach to testing and assessment and a group of standardized test methods.

In the view of the drafter a criterion for the degradation is not needed. Also in the case of other POPs such a criterion was not developed. If a substance degrades to a POP, the degradation product is a POP. This is true even if degradation occurs over long time frames (e.g. in the case of decaBDE).

Japan General It is rather difficult for the Government of Japan to support a RME without having a list of chemicals to be added to Annex A to the Convention, which should include CAS registry number and scientific evidence/explanation of degradation to PFOA for each “PFOA-related compound” listed

This issue should be discussed at the POPRC meeting. In the case of PFOS an exhaustive list of substances was not added to Annex B. CAS Numbers for PFOA, its salts and PFOA related compounds are given in the non-exhaustive list of substances and in the risk profile background document. (See UNEP/POPS/POPRC.12/INF/5). Moreover, major synthesis routes of fluorotelomer-based substances including side-chain fluorinated polymers as well as an overview of the syntheses routes of major fluoropolymers are available based on additional information provided by the Swiss Federal Office for the Environment (see new para below Table 2).

Japan 3 In the way of thinking about degradation from PFOA-related substances to PFOA, abiotic(photo-) degradation plays essential role unlike that of other POPs. It should be clarified in RME.

Edited

Japan 6 The term “PFOA, its salts and PFOA-related compounds” should be used here because this is not quoted from other

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information.

Japan 8 , its salts” should be added. Edited

Japan 11 Text: … aqueous film-forming foams…Comment: An abbreviation should be added.

Edited

Japan 15 Text: Those PFASs, which can be degraded to PFOA in the environment, are referred to as PFOA-related compoundsSuggestion to add “…via biotic and/or abiotic process…”Comment: In the way of thinking about degradation from PFOA-related substances to PFOA, abiotic (photo-) degradation plays essential role unlike that of other POPs. It should be clarified in RME.

We agree that abiotic (photo-) degradation from PFOA-related substances to PFOA plays an essential role (see comment from Japan on para 3). However, we think that this is covered by the term “…which can be degraded to PFOA in the environment and an adjustment of the wording is not necessary.

Japan 26b “Derogation” should read “exemption” so as not to confuse readers.

Not edited since this part of para 26b has been deleted (see comment Austria, para 26b)

Japan 33 The term “PFOA-related compounds” should be used here because this is not quoted from other information.

Edited

Japan 33 “…, its salts” should be added. Edited

Japan 36 More explanation of the description “1000ppb” is needed. More information concerning discussed limit values is added to para 36 (see comment Austria, para 36; Switzerland para 36)

Japan 46 Text: Signatories to the Agreement agreed to reduce the amount of PFOA its salts and related substances and LC-PFCAs in perfluorinated chemicals in commerce by 95% by December 31, 2010, and to eliminate them by December 31, 2015Comment: “PFOA-related” should be added.

Not edited. The text has been changed to “Signatories to the Agreement agreed to reduce the amount of PFOA and LC-PFCAs in perfluorinated chemicals in commerce by 95% by December 31, 2010, and to eliminate them by December 31, 2015” as stated in the cited reference (Canada, 2016c)

Japan 55 “Derogations” should read “exemptions” so as not to confuse readers.

Edited. Please note that para 55 has been merged with para 50 (see comment Austria, para 55)


Edited

Japan 61 Text: This sector is responsible for a very low share of total emission of PFOA and PFOA-related substancesComment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.

Edited

Japan 61 Text: Because of the low amounts used and the fact that emissions are expected to be low a time limited derogation (5 years after entry into force of the Regulation) for the equipment used to manufacture semiconductors is proposed in the EU restriction proposal. Besides, an derogation without time limitation is proposed in photo-lithography processes for semiconductors or in etching processes for compound semiconductors (EUROPEAN COMMISSION, 2017)Comment: “Derogation” should read “exemption” so as not to confuse readers.

Not edited. The term “derogation” has not been exchanged by the term “exemption” since the wording of the quoted EU-reference (ECHA, 2015c; reference added later) is “derogation”.

Japan 63 Text: Overall, it cannot be fully assessed whether derogation is justified in the professional sector due to data gaps mainly on volumes, specific uses and substances.Comment: “Derogation” should read “exemption” so as not to confuse readers.

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Japan 63 Suggestion to change the sentence “For textiles for the protection of workers from risks to their health and safety a time limited derogation (6 years after entry into force of the Regulation) is proposed in the EU” to “For textiles for the protection of workers from risks to their health and safety, there are some alternatives available (FluoroCouncil 2016a) and a time limited derogation (6 years after entry into force of the Regulation) is proposed in the EU”Comment: Short-chain fluorinated commercial products can substitute some of the high performance requirements according to information from the industry.

Not edited (please see comment FluoroCouncil on Summary Table in section 2.3.4)

Japan 65 “Derogation” should read “exemption” so as not to confuse readers.

Edited

Japan 66 Text: Within their life cycle technical textiles are rarely washed nor are they in environmental contact under conditions that elute PFOA or related substances into the environment, having in mind, that the treatment with fluorinated products has the aim to minimize the influence of the environment by durable oil- and water repellencyComment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.

Not edited since this part of para 66 has been deleted (see comment Austria, para 66)

Japan 68 Text: One company illustrated that an unavoidable fraction of PFOA and PFOA-related substances is created when manufacturing short chain fluorinated alternativesComment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.

Not edited. The wording has been adapted from ECHA, 2015a and thus not been changed.

Japan 68 Text: Industry is planning to reprocess the fraction of PFOA and PFOA-related substances back into C6-chemistry.Comment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.


Japan 68 Text: Industry is planning to reprocess the fraction of PFOA and PFOA-related substances back into C6-chemistry.Comment: It’s not clear if this statement refers to the whole industry of manufacturing fluorinated telomer substances. Unless confirmed, it should be deleted.

Not Edited. Please see other comments on para 68, particularly from FluoroCouncil

Japan 68 Text: In that case it has to be ensured that PFOA and PFOA-related substances are on-site isolated intermediate and handled under strictly controlled emissionsComment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.


Japan 68 Text: The proposed set of thresholds within the EU takes the currently unavoidable fraction of PFOA and PFOA-related substances during production of short-chain alternatives into accountComment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.


Japan 69 Suggestion to add: PFOB (perfluorooctyl bromide) is produced from PFOI (perfluoroactyl iodide), PFOB is being used as a processing aid to manufacture some specific pharmaceutical products for the treatment of the patients with chronic obstructive pulmonary disease (COPD). The usage of PFOB can achieve to make

PFOI is in the scope of the RME (see non-exhaustive list of substances). PFOB is not in the scope of the RME (excluded according to para 16 (i) because it does not degrade to PFOA).Hence, if the use of PFOI is the only

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pharmaceutical product microporous sphere and to combine more than two pharmaceutical products into one particle with desirable ratios to maximize the effect. Without PFOB, this cannot be achieved. The production of PFOB for the purpose of producing pharmaceutical products should be considered as an exemption.Comment: More detailed discussion about the exemption of producing process of pharmaceuticals among the intersessional group or POPRC is necessary and some supporting document are referred below;1) The related technology; “Co-suspensions of Microcrystals and Engineered Microparticles for Uniform and Efficient Delivery of Respiratory therapeutics from Pressurized Metered Dose Inhalers“, Reinhard Vehring et al, Langmuir, 2012, 28, 15015 – 150232) Impact of COPD on daily livers of suffers; “COPD uncovered: an international survey on the impact of chronic obstructive pulmonary disease (COPD) on a working age population“ Fletcher et al. BMC Public Health 2011, 11, 6123) High level details from the technology; “Efficacy and Safety of Glycopyrrolate/Formoterol Metered Dose Inhaler Formulated Using Co-suspension Delivery technology in Patients With COPD“Fernaondo J. Martinez et al. CHEST 151#2, February 2017

reasonable way to produce PFOB, an exemption could be considered for the use of PFOI for the production of PFOB for the purpose of producing pharmaceutical products.Could you please provide information whether the use of PFOI is the only reasonable way to produce PFOB in order justifies a corresponding exemption?Another alternative could be that the use of PFOI for the production of PFOB for the purpose of producing pharmaceutical products could benefit from the closed-system site-limited intermediate exemption (see Stockholm Convention text, note (iii) of Part I of Annexes A and B).The following information was added to para 69: “PFOB (perfluorooctyl bromide) is produced from PFOI (perfluoroactyl iodide). PFOB is being dominantly used as a processing aid to manufacture some specific “micro-porus” pharmaceutical products for the treatment of the patients with chronic obstructive pulmonary disease (COPD), whereas research on additional pharmaceutical applications is ongoing. The usage of PFOB can allow to make pharmaceutical product microporous sphere and to combine more than two pharmaceutical products into one particle with desirable ratios to maximize the effect. PFOI may be present in final drug as a residue, in the range of a few ppm, as estimated by Daikin. At present, no alternatives to PFOB are available to meet product performance for this specific type of uses (comment Daikin on the 2nd draft RME). The production of PFOB for the purpose of producing pharmaceutical products should be considered as an exemption (comment Japan on the 2nd draft RME referring to Vehring et al., 2012 Fletcher et al., 2011 and Martinez et al., 2017).”Note: The following information has been added to para 186: “According to information provided, PFOB is produced from PFOI. PFOB is being used as a processing aid to manufacture some specific pharmaceutical products (see para x). PFOI is in the scope of the RME (see non-exhaustive list of substances). PFOB is not in the scope of the RME (excluded according to para x because it does not degrade to PFOA). If the use of PFOI is the only reasonable way to produce PFOB, an exemption could be considered for the use of PFOI for the production of PFOB for

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the purpose of producing pharmaceutical products. Currently, Daikin produces PFOI at one single site in Japan during the production of 6:2 fluorotelomer-based substances, and then transports a fraction of the isolated PFOI to another site in Japan to produce PFOB. Afterwards, PFOB is transported to two sites in the US to produce relevant pharmaceutical products (comment Daikin on the 2nd draft RME). It should also be verified, whether the closed-system site-limited intermediate exemption (see Stockholm Convention text, note (iii) of Part I of Annexes A and B) or exemptions for transported isolated intermediates could be relevant for this use.”We generally agree that a more detailed discussion about the exemption of production process of pharmaceuticals is necessary.The indicated references were checked for information related to PFOB/PFOI. The references contribute to the general discussion of PFOB being used for the manufacture of pharmaceuticals but they do not provide evidence regarding the use of PFOI for the production of PFOB.1) This reference does not address that PFOB is being produced from PFOI. It focusses on a new formulation approach based on engineered microparticles to avoid former disadvantages of pMDI suspensions and provides information that it is well suited for chronic respiratory illnesses.2) This reference does not address the manufacture and use of PFOB. It focusses on the impact and range of COPD within the population.3) This reference does not address the manufacture and use of PFOB.Consequently, the provided information does not clarify whether PFOI is the only reasonable way to produce PFOB. Further information will be necessary for an evaluation.

Japan 69 Suggestion to delete the part: “There is no information specifying “other highly specialized chemicals”. According to IPEN, more than 100 countries agreed that environmentally persistent pharmaceutical pollutants are a global emerging policy issue in the SAICM process and this issue should be closely examined before considering exemptions (comment IPEN 2017)

This part of para 69 has been adjusted (see comment from Netherlands, para 69)


Edited


Edited

Japan 72 “Derogation” should read “exemption” so as not to Edited

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confuse readers.

Japan 73 Text: For plasma nano-coating time-limited derogation is proposed within the EU.Comment: “Derogations” should read “exemptions” so as not to confuse readers.

Not edited. This part of para 73 has been deleted (see comment Sweden, para 73)

Japan 73 Text: Only one company applying coating for smartphone manufacturers requested during the public EU stakeholder consultation on the restriction dossier derogation for 3 years for pulsed plasma nano coating was requested in order to be able to move to an alternative C6 chemical.Comment: “Derogation” should read “exemption” so as not to confuse readers.

Not edited. The wording has been adapted from ECHA, 2015c and thus not been changed.

Japan 73 Text: On this basis, for plasma nano coating a time limited derogation (6 years after entry into force of the Regulation) is proposed in the EU (EUROPEAN COMMISSION, 2017)Comment: “Derogation” should read “exemption” so as not to confuse readers.

Edited

Japan 74 Text: According to their comments, in the absence of derogation, those spare parts would have to be destroyed, which would represent an economic loss for EU manufacturers. The scientific committee finds derogation for spare parts in stock before the entry into force of the restriction justified for all applications, including the cases mentioned above as well as other cases), given the costs of their elimination and low emissions associated with their prolonged life (ECHA, 2015c).Comment: “Derogation” should read “exemption” so as not to confuse readers.


Japan 76 Text: Regarding the placing on the market of new firefighting foams, SEAC notes that during the Public Consultations, some stakeholders (firefighting services, foams manufacturers) have requested higher concentration limits for PFOA-related substances and PFOA, or total exemption of firefighting foams. Overall, given the information provided, SEAC proposes to adopt a higher limit value of 1 000 ppb per substance, for both PFOA or for each PFOA-related substance when used in firefighting foam concentrates, and to reconsider this concentration limit with an aim to lower it in the proposed review of the restriction 5 years after entry into force. (ECHA, 2015c)Comment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.


Japan 77 Text: Within the EU restriction proposal a derogation is proposed for concentrated fire-fighting foam mixtures that were placed on the market (3 years after date of entry into force of the Regulation) and are to be used, or are used in the production of other fire-fighting foam mixtures. Besides, a derogation is proposed for fire-fighting foam mixtures a) placed on the market before (3 years after entry into force of the Regulation) or b) produced in accordance with paragraph 4(e), provided that, where they are used for training purposes, emissions to the environment are minimized and effluents collected are safely disposed of (EUROPEAN COMMISSION, 2017)Comment: “Derogation” should read “exemption” so as not to confuse readers.

Edited

Japan 79 Text: Within the EU restriction proposal time limited derogation (15 years after entry into force of the

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Regulation) is proposed for medical devices other than implantable medical devices within the scope of Directive 93/42/EEC. Besides, a derogation without time limitation is proposed in the production of certain implantable devices (EUROPEAN COMMISSION, 2017)

Japan 84 and 85 The term “PFOA-related compounds” should be used here because this is not quoted from other information.


Japan 94 Text: According to I&P Europe, the primary barrier to complete elimination of the use of PFOA-related substances at this time remains technicalComment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.

Edited

Japan 94 As a matter of fact the economic cost associated with substitution of PFOA-related substances in the few remaining critical photographic uses has in most cases become prohibitive, the small remaining critical uses being niche products in markets that IP Europe members anticipate to further decline (I&P Europe, 2016b).Comment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.

Edited

Japan 95 Text: This figure does not include the transition and qualification costs for downstream users to replace PFOA and its related substances, which varied significantly up to over €1,000,000 per use per company, depending on the application.Comment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.

Edited

Japan 95 Text: Another cost to be recognized is the economic and human health cost of completely ceasing production of certain PFOA related chemicals used in pharmaceuticals and other highly specialized applicationsComment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.

Not edited in order to avoid misleading reproduction of provided information


Not edited. The respective part of para 97 has been deleted.

Japan 100-112 This section (paras 100-112) should be minimized so as not to prejudge outcomes of assessing the chemical properties of alternatives.

Please indicate specific sections in paras 100-112 that should be shortened and explain for each section why to shorten.

Japan 103 Text: Other short-chain fluorinated alternatives for PFOA-related substances are degraded to these acids as well (ECHA, 2015a).Comment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.

Not edited. The respective part of para 97 has been deleted (see comment Switzerland, para 103)

Japan 110 and 139

The term “PFOA-related compounds” should be used here because this is not quoted from other information.

Edited

Japan 141 Text: However, some critical uses with respect to PFOA-related substances as a constituent material in process chemical formulations for very specialized application steps (e.g. for the photolithographic applications) remain.Comment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.

Not edited. The wording has been adapted from van der Putte et al., 2010 and thus not been changed.

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Japan 141 Text: For those companies using PFOA within their critical photolithographic applications derogations will be necessary in order to be able to continue production (van der Putte et al., 2010).Comment: “Derogation” should read “exemption” so as not to confuse readers.

Not edited. The wording has been adapted from van der Putte et al., 2010 and thus not been changed.

Japan 144 The number and title of table should be added. Edited


Edited

Japan 146 Text: Even if the emissions of PFOA and PFOA-related substances will cease, it will not result in an immediate reduction of environmental concentrations.Comment: The term “PFOA, its salts and PFOA-related compounds” should be used here because this is not quoted from other information.


Japan 146 Text: The magnitude and extent of the risks of PFOA and PFOA-related substances as PBT substances remain uncertain.Comment: The term “PFOA, its salts and PFOA-related compounds” should be used here because this is not quoted from other information.


Japan 146 Text: . It is evident that even though the full physical impacts on human health and the environment of reducing the emissions of PFOA and PFOA-related substances cannot be quantified (ECHA, 2015a).Comment: The term “PFOA, its salts and PFOA-related compounds” should be used here because this is not quoted from other information.


Japan 147 Text: The EU proposal for a restriction of PFOA and PFOA-related substances will require industry to phase out respective compounds in nearly all applications and sectors, eliminating all significant emission sources (apart from releases originating from the existing stock and exempted uses of PFOA and PFOA-related substances) (ECHA, 2015a).Comment: The term “PFOA, its salts and PFOA-related compounds” should be used here because this is not quoted from other information.


Japan 147 Text: However, based on the analysis of alternatives they are expected to pose lower health risks than PFOA and PFOA-related substances.Comment: The term “PFOA, its salts and PFOA-related compounds” should be used here because this is not quoted from other information.


Japan 151 Text: According to representatives of the European photo industry, control measures implemented by the photo imaging industry, including reformulation and product discontinuance, have reduced the use of PFOA-related substances worldwide by more than 95%.Comment: The term “PFOA, its salts and PFOA-related compounds” should be used here because this is not quoted from other information.

The wording of the sentence has been changed to “According to representatives of the European photo industry, control measures implemented by the photo imaging industry, including reformulation and product discontinuance, have reduced the use of PFOA-related compounds worldwide by more than 95%.

Japan 154 Text: There is widespread occurrence of PFOA and a number of PFOA-related compounds in environmental compartments and in biota and humans.Comment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.

Not edited. The wording has been adapted from UNEP/POPS/POPRC.12/11/Add.2 and thus not been changed.

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Japan 154 Text: Restricting PFOA, its salts and related compounds would positively impact on biota by decreasing emissions and subsequently exposure of biota.Comment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.

Edited

Japan 156 Text: In the EU, the use of PFOA and PFOA-related substances has contributed to the contamination of (drinking) water and soil with corresponding high costs of remediation. Most of the contamination has been caused by the use of PFAS (including PFOA and PFOA-related substances) in firefighting foams in fire events and training exercises.Comment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.


Japan 156 Text: Where costs are reported, they are very case specific often covering also other PFAS, which makes it very difficult to derive a robust general estimate of remediation cost per kg PFOA and PFOA-related substances. . However, the data available indicate that there are considerable costs related to the remediation of PFAS including PFOA and PFOA-related substances.Comment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.


Japan 156 Text: Environmental contamination with PFOA and PFOA-related substances is also related to industrial activities according to examples e.g. from the U.S.Comment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.

Edited

Japan 156 Text: Identification and management of contaminated sites and groundwater can cause significant costs which will be reduced in the future if PFOA and related substances will be restricted.Comment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.

Edited

Japan 157 Text: The regulatory proposals for PFOA restrictions in Canada, the EU and Norway are not expected to lead to wider economic impacts, because the market is already replacing PFOA and PFOA-related substances.Comment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.


Japan 159 Norway states that the continued use of PFOA and PFOA-related substances in textiles causes high socio-economic costs due to the PBT properties of the substances.Comment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.

Edited

Japan 160 Text: The photo imaging industry has been very successful at developing alternatives for most uses of PFOA-related substances, eliminating more than 95% of the worldwide use since 2000. However, the industry claims that the surfactant and static control properties of PFOA-related substances are important for the application of coating layers during manufacture of some remaining traditional film products (i.e. products in which the image

Edited

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formation is based on silver halide technology). The industry cannot estimate the cost of replacing this use of PFOA-related substances, but notes that these are niche products in markets that will diminish (I&P Europe, 2016a).Comment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.

Japan 174 Text: Indirect releases occur from the degradation or transformation of precursors.Comment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.

Not edited. The wording has been adapted from UNEP/POPS/POPRC.12/11/Add.2 and thus not been changed.Please note that para 174 has been moved to the beginning of section 2.

Japan 175 Text: Therefore, it is concluded that PFOA, its salts and related compounds that degrade to PFOA are likely, as a result of their long-range environmental transport, to lead to significant adverse human health and/or environmental effects such that global action is warranted (UNEP/POPS/POPRC.12/11/Add.2).Comment: This explanation is not needed since PFOA-related compounds have already been defined above.

Not edited. The wording has been adapted from UNEP/POPS/POPRC.12/11/Add.2 and thus not been changed.

Japan 176 Text: Based on the available information, it is not possible to definitively identify specific uses or PFOA-related substances that will not contribute to PFOA emissions, but PFOA emissions from photographic applications and from the semiconductor industry appear to be less than 100 kg/year for the whole EU (and therefore lower risk in relative terms) (ECHA 2015c).Comment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.



Edited

Japan 185 Text: The set of thresholds in the EU restriction proposal is based on information from industry and takes the currently unavoidable fraction of PFOA and PFOA-related substances during production of short-chain alternatives already into account.Comment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.


Japan 194 Text: The magnitude and extent of the risks of PFOA and PFOA-related substances as POP substances cannot be quantified, but global action is warranted.Comment: The term “PFOA, its salts and PFOA-related compounds” should be used here because this is not quoted from other information.


Japan 195 Text: Based on the analysis of their characteristics, some of the available alternatives are expected to pose lower health risks than PFOA and PFOA-related substances.Comment: The term “PFOA, its salts and PFOA-related compounds” should be used here because this is not quoted from other information.


Japan 195 Text: The EU and the Canadian restriction approaches are considered to have moderate cost impacts because the market is already replacing PFOA and PFOA-related substances and because the restriction approaches provide time-limited exemptions and ongoing permitted uses for certain applications where the development of alternatives


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is underway or where there are currently no known alternatives.Comment: The term “PFOA, its salts and PFOA-related compounds” should be used here because this is not quoted from other information.

Japan 197 Text: Restricting or prohibiting PFOA, its salts and related compounds would reduce costs by decreasing contamination of surface water groundwater and soil and would thus reduce costs for identification and remediation of contaminated sites.Comment: The term “PFOA-related compounds” should be used here because this is not quoted from other information.

Edited

Japan 197 Text: The data available indicate that there are considerable costs related to the remediation of PFAS including PFOA and PFOA-related substances.Comment: The term “PFOA, its salts and PFOA-related compounds” should be used here because this is not quoted from other information.


Japan 203 As mentioned in para 69, the production of PFOB for the purpose of producing pharmaceutical products should be considered as an exemption.

Please see response to comment Japan to para 69 on the issue of PFOI/PFOB

Japan Summary Table of chapter 2.3.4

Textile sector: Suggestion to change “no” to “some of” in the column “appropriate alternative available” and add “Short-chain fluorinated products (e.g. C6-based) ” in the column “type of alternatives”Comment: Short-chain fluorinated commercial products can substitute some of the high performance requirements according to information from the industry.

Not edited (see comment FluoroCouncil, Summary Table of chapter 2.3.4)

Japan List of substances

Even for the non-exhaustive list, the overall reasoning for selection of chemicals is desirable and scientific evidence/explanation of degradation to PFOA for each PFOA-related compound listed should be included.

Scientific evidence/explanation of degradation to PFOA for each PFOA-related compound listed cannot be provided. However, Section II of the additional information from Switzerland (FOEN, 2017) provides information related to the transformation/degradation of fluorotelomers to PFOA.

Japan List of substances

In the non-exhaustive list, a branched PFOA whose CASN is 1882109-69-4 and whose (tentative) chemical name is "Pentanoic acid, 3,4,4,5,5,5-hexafluoro-2,2,3-(trifluoromethyl)-" should be added to the section of PFOA isomers.

Edited

Mauritius Chapter 1.1 …it will be highly appreciated if the exact HS Code for Dicofol and PFOA, if available, could be included under the Chemical Identify Section for Dicofol and PFOA. This will further facilitate control in terms of exportation and importation of these chemicals.

A specific HS code for PFOA is not available (see https://unstats.un.org/unsd/tradekb/Knowledgebase/Harmonized-Commodity-Description-and-Coding-Systems-HS) and can therefore not be indicated.

Netherlands General General comments from the Netherlands which are not addressed in the responses to specific comments below:Comment 1: The Netherlands NFP appreciates that the drafters of the Risk Management Evaluation (RME) took serious note of item (g) under Annex F: Any national or regional control actions taken, including information on alternatives, and other relevant risk management information, being a prerequisite to come to a proper implementation of the listing of PFOA and related compounds in the Stockholm Convention.

Comments notedResponse to comment 2: The drafter agrees that the ultimate goal is listing PFOA in the Convention. We do not agree that the executive summary is written in a way that does not lead to a clear recommendation to COP. If the POPRC does not come to a clear recommendation it may also decide that another intersessional process

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Comment 2: The ultimate goal is listing PFOA in the Convention. The executive summary is written in a generic way that doesn’t lead to a clear recommendation to the COP how to list PFOA and which exemptions are needed. Another intersessional process might be needed to sharpen the picture to be discussed at the next COP.Comment 3: Furthermore important is an overview of the (un)availability of alternatives and related to that the need for exemptions.Comment 4: Please note the preference for references which can be traced back instead of referring to comments.

might be needed.Response to comment 3: An overview on the availability of alternatives is provided in the Table below para 144. Where exemptions could or should be granted (decision should be left to the POPRC) is summarized in section 3.2 and is reflected in the concluding statement.Response to comment 4: We agree. However, when there is no specific reference available we suggest referring to the comments. The comments are published at the SC website (http://chm.pops.int/TheConvention/POPsReviewCommittee/Meetings/POPRC12/POPRC12Followup/tabid/5339/Default.aspx) and thus the information is traceable.

Netherlands 7 Text: However, for most of these uses the development of alternatives is underway. In restricting or banning PFOA, its salts and PFOA-related compounds under the Stockholm Convention this could be considered with specific exemptions or acceptable purposes with or without time limit.Comment: It should be clear from this RME for which uses alternatives are available and for which uses there are no alternatives. The latter including reflections on the need for specific exemptions or acceptable purposes.

We agree. To this end information on critical uses (section 2.2.1) and alternatives (section 2.3) is compiled and synthesized in section 3.2. This can be used as a basis for discussion at the POPRC meeting for possible exemptions.Exemptions recommended by the POPRC could be either specific exemptions (in Annex A or B) or acceptable purposes (only in Annex B).The drafter considers specific exemptions appropriate if the ultimate objective is to end an activity (production or use) in the future.The drafter considers an acceptable purpose could be appropriate if it is considered that an activity will have to be continued in the long range future (i.e. without time limit or if a very long phase-out time is required e.g. over many decades).Further, the drafter considers that, if the ultimate objective is to end an exempted activity in the future (which corresponds to elimination), listing in Annex A with a specific exemption should be preferred over listing in Annex B with a specific exemption or an acceptable purpose.

Netherlands 8 Text: The full magnitude and extent of the risks of PFOA and PFOA-related compounds as POP substances cannot be quantified but global action is warranted.Comment: More a political statement than a scientific underpinning. No proof but action needed…..

Yes, and therefore “The risk management of these substances is driven by scientific data and precautionary action in order to avoid the potentially severe and irreversible impacts resulting from continued unrestricted emissions.” As continued in the same para.

Netherlands 8 Text: “…resulting from continued unrestricted emissions.Comment: Are there still unregulated emissions in EU or

The RME is related to the global level.

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WEOG? I would expect BAT/BEP preventing such emissions.

Netherlands 8 Text: The Canadian and Norwegian restrictions and the proposed EU restriction is expected to result in a net benefit to society in terms of human health impacts and an improvement in environmental quality from controlling these substances.Comment: Is expected? There should be evidence.

The expectation is based on the work of scientific committees and further e.g. in section 2.2.2.

Netherlands 9 Text: Cost competitive alternatives to PFOA, its salts and PFOA-related compounds that do not exhibit POPs characteristics have already been implemented in many countries. This indicates partial economic and technical feasibility of alternatives.Comment: Reads as conflicting with information in para 7.

The sentence “This indicates partial economic and technical feasibility of alternatives.” Makes clear that there are also uses for which alternatives are currently not available.

Netherlands 9 Text: Further, a restriction or prohibition would lead to a decrease in contamination of surface water, groundwater and soil and would thus reduce costs for identification and remediation of contaminated sites.Comment: Would lead to a decrease and reduction of cost? Should be referenced. Drafters could ask industry to clarify their findings in phasing out C8-technology.

Would lead to a reduction of costs for identification and remediation of contaminated sites.See para 149: “Australia expects positive impacts from control measures related to avoided contamination of surface water, groundwater and drinking water and positive impact on public health (Australia, 2016; see also section 2.2.2).”Costs for remediation are high (see e.g. contributions from Germany).Information on substitution costs for industry is e.g. given in para 82.

Netherlands 11 The 8 exemptions here differ from the 10 mentioned in para 7. This leads to questions like: what happened with latex printing inks or with plasma nano-coatings? Also other questions could be formulated, but I presume the message is understood.

In para 7 ten identified uses for which alternatives are currently not available are listed. Based on the risk management evaluation, for three of these ten uses, an exemption is not considered appropriate:latex printing inksplasma nano-coatingscertain pharmaceutical chemicalsIn para 11 all eight identified uses are listed for which, according to the risk management evaluation, exemptions are considered appropriate. This includes seven uses listed in para 7 plus the use in AFFFs used in firefighting applications.Justification is provided in the RME.For the use in AFFFs used in firefighting applications alternatives are available. However, an exemption is considered appropriate to enable the use of foams already in use (summary see para 189).Justification for the three uses where an exemption is not considered appropriate is given in the RME. Summary in paras 184 (latex printing inks), 188 (plasma nano-coating) and 186 (certain pharmaceutical

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chemicals).

Netherlands 26 Please present in the logical sequential order, starting with USA.

Could you please specify a logical sequential order?

Netherlands 26(a) Text: …on request industry is obliged to inform consumers on the occurrence to the listed substances in consumer articles if the SVHC in those articles is present in a concentration of more than 0.1 % (w/w).Comment 1: Products (instead of articles)?Comment 2: Suggestion is to insert a table here or at a more appropriate place (for example in para 1.1) presenting actual concentrations or a band of concentrations which are specific for a certain use. Preferably in ppb or alternatively in microgram per square meter. This information is helpful in determining the status when a product enters the waste stage. Very relevant to inform consumers and recyclers of PFOA concentrations in those waste materials.

Response 1: This para is on EU Regulation. In this context “articles” is the correct term.Response 2: See comment Netherlands on para 60.

Netherlands 26(d) As far as I know still pending a verdict of the EFTA Court of Justice E-9/16.

Can Norway possibly say something on this comment?

Netherlands 29 At EU level, Germany and Sweden are preparing a restriction proposal for the long-chain perfluorinated carboxylic alkyl acids of chain lengths between 9 and 14 carbon atoms and related substances. As far as possible, information generated in the process of elaborating this restriction proposal will be considered for the draft risk management evaluation.What does this mean? When the new dossier is found not in conformity the POP RC cannot use that information. When ECHA submits its opinion together with the background document, the information can be used.

The drafter is in contact with the German and Swedish authorities. If information which is considered useful for the RME becomes available during drafting, it is foreseen to take such information into consideration.

Netherlands 31 Text: Possible control measures may include… …(6) prohibition of reuse and recycling of wastes or stockpilesComment: Also related to the low POP content, see article 6 SC.

Yes

Netherlands 34 Text: According to IPEN In order to reduce and eliminate emissions of PFOA and PFOA-related compounds, control measures at all life cycle stages need to be in place. The most cost effective and practicable control measure for PFOA and PFOA-related compounds is the prohibition of all production, use, import and export.Comment: Statement needs a scientific reference or should be deleted.

“According to IPEN” is moved to the beginning of the second sentence. It is made clear that all which follows in this para is a statement by IPEN and does not preclude any Decisions by the POPRC.

Netherlands 34 Text: This would be best accomplished by listing PFOA, its salts and PFOA-related compound in Annex A of the Stockholm ConventionComment: To be decided by the POP RC

Yes. See previous response

Netherlands 34 Text: Measures under Article 6 would address the clean-up of contaminated sites, such as at or near manufacturing facilities, airports, military bases and other sources, and environmentally sound management of stockpiles and wastes (comment IPEN 2017).Comment 1: Convention obligations are not an element in Annex FComment 2: Status of the IPEN Comment?

Response 1: Yes, however, Annex F includes “Waste and disposal implications (in particular, obsolete stocks of pesticides and clean-up of contaminated sites)”Response 2: Edited; Comment IPEN on para 32 of the first draft RME

Netherlands 36 Text: are modified notably raising the 2 ppb threshold to 25 ppb/1000 ppb.Comment: In my view this would require more explanation. First question is how this compares to the detection limits? 2nd if there are standardized analytical

Edited. Explanation has been added:“…the EU restriction was adjusted to the occurrence in concentrations equal to or greater than 25 ppb of PFOA including its salts or 1000 ppb of one

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test methods? And 3rd what this means in the waste stage? 4th: how does this relate to the 50 ppm concentration limit for PFOS?

or a combination of PFOA-related substances. These limit values reflect the possible presence of unavoidable impurities and unintended contaminants, and take account of the capabilities of analytical methods (see European Commission, 2017)., provided that the scope and conditions are modified notably raising the 2 ppb threshold to 25 ppb/1000 ppb. Based on this consideration as well as other stakeholder contributions, the initial restriction proposal was modified. Details on the modifications by proposed by the scientific committees within the EU are documented in (ECHA, 2015c).”This answers questions 1 and 2.Response to question 3: Concerning waste this means, that in the long-range future, concentrations above 25 ppb of PFOA including its salts or 1000 ppb of one or a combination of PFOA-related substances should not occur.Response to question 4: There is no relation to the 50 ppm concentration limit for PFOS. A concentration limit for PFOA needs possibly to be derived in the future.

Netherlands 37 1. I wonder if drafters can refer to a draft regulation. We do not refer to e.g. draft guidance, as drafts can differ from the adopted version.2. And if drafters want to present draft regulations, present this in table form as done in the draft EU Regulation. That would ease reading of the proposed restriction, including the numbering of the para’s in that Regulation.

Response 1: As mentioned in the footnote, the adopted restriction will be published in April or May 2017 in the Official Journal of the European Union. In the final version of the risk management evaluation a reference to the Official Journal will be provided.Response 2: in order to save space (due to page limits) the content of the draft regulation is presented as text. Interested readers can use the original source and view the table form. According to other comments on para 37 (Austria, Sweden) the para will be moved to the Background Document.

Netherlands 41, Table 3 Good to compare these regulations in this way. Comment noted

Netherlands 41, Table 3 Text: Note: not relevant for this specific regulation in Norway since it concerns consumer products (and aqueous film-foaming firefighting foams are for professional use only)Comment: In the EU C8-foams are phased out. Use still allowed in Norway?

Yes. There are no exemptions in place for firefighting foams in Norway, however, the restriction does not apply since it concerns consumer products and AFFF are for professional use only. Hence AFFF for professional use is still allowed in Norway. (see also para 77)

Netherlands 46 Would be good to report on experiences, results and cost. Canada could possibly provide specific information.

Netherlands 52, 53 From general comments:Measures on PFOA have been taken in a number of jurisdictions starting ten years ago. Paragraph 52 describes some generic principles on measures and paragraph 53 describes that Canada has undertaken research on potential releases from waste management in

Canada could possibly provide specific information.In general, relevant information on experiences with waste treatment of PFOA containing materials in other jurisdictions would be welcome.

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2012. It would be helpful to learn whether these results are available. Furthermore helpful is more insight what the experiences are with waste treatment of PFOA containing materials in other jurisdictions.

Netherlands 55 Text: The Swedish Chemicals Agency has in a governmental assignment proposed that PFASs-containing fire-fighting foams must be collected and destroyed after being used (with some derogation) (Swedish Chemicals Agency (2016a). The Swedish Chemicals Agency has also provided training for fire-fighters as well as a brochure with recommendations for a reduced use of PFASs-containing fire-fighting foams.Comment: What were experiences in this program?

Sweden could possibly provide specific information.Note: The information has been moved to para 50.

Netherlands 57 Text: Concerning stockpiles of PFOA, an appropriate storage of PFOA wastes until the proper capacity is available for destruction is required to limit environmental impacts (Canada, 2016a).Comment: Is required: has it been realized?

No. Canada stated in its Annex F submission (Canada, 2016a) that the temporary storage of PFOA wastes in an environmentally sound manner will be key in the RME to ensure environmental impacts are limited, until the proper capacity is available for the destruction.

Netherlands 59 Text: IPEN recommends within the short-term to use best available techniques and best environmental practice destruction technologies for wastes containing PFOA. There should be no permission of landfilling these wastes, unless leachate containing PFOA is properly treated. In case destruction technologies are not available, safe storage has to be ensured.Comment: POPRC should look into the feasibility for Parties following this recommendation. It would assume Parties building warehouses for sludge storage…..

Comment noted. Information on the feasibility of this recommendation is welcome.Note: para 59 has been merged with para 52. Repeated information is deleted.

Netherlands 59 Text: It is furthermore recommended that occupational exposure at production/industrial use facilities is monitored and that appropriate occupational health and safety measures are implemented. Within the medium-term, if contamination has occurred, IPEN recommends to carry out remediation activities in accordance with the “polluter-pays” principle with the aim to reduce risk (IPEN, 2016a).Comment 1: Why make a recommendation as this is an obligation according to article 3.6 of the Convention?Comment 2: Depending on technical and economic feasibility, availability of resources, etc.

The recommendation stems from Decision POPRC-6/2Note: para 59 has been merged with para 52. Repeated information is deleted.

Netherlands 60 Text: Following a listing of PFOA, its salts and PFOA-related compounds in the Stockholm Convention a concentration level for low POP content would typically be established in cooperation with the Basel Convention, which also typically will be tasked with determining the methods that constitute environmentally sound disposal.Comment: To enable such action I recommend to present concentration bands of PFOA and related substances in the respective applications as textiles, inks, semiconductor etc. in a table.From general comments: What is lacking is an overview of concentration (bands) in all the applications, including information about identification or detection methods and levels. This would be very relevant for uses or applications entering the waste stage.

We agree. It will be helpful to compile information on concentrations or concentration ranges for PFOA, its salts and PFOA-related compounds in typical uses, products and wastes in order to facilitate future implementation issues. Such information is not available to the drafter but will be required if PFOA, its salts and PFOA-related compounds will be listed for future implementation issues.

Netherlands Section 4.2.1

What are criteria for critical uses? The existing exemptions? The concept is introduced without any

Edited. See response to comment

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explanation. Switzerland on para 61ff

Netherlands 64 Text: These are complemented by standards and regulations of separate enterprises, dealing even more detailed with requirements for parts of cars, machines, apparel called in Germany “TL” which could be translated i.e. Technical Performance profile. The German textile industry staff is adequately trained, the occupational health and safety is strictly fulfilled and monitored (VTB SWT, 2016). However, according to IPEN, the PFOA amounts and manufacturing process and conditions in other countries and regions are not known and could be substantial, resulting in human exposure and environmental releases (comment IPEN 2017).Comment: Suggestion is to elaborate the standards used in Germany as examples of good practice that deserves to be followed. It’s up to IPEN to demonstrate that conditions for manufacturing in other regions are poor.

Edited.The following has been added: “Technical standards such as those used in Germany could be elaborated as examples of good practice (Comment Netherlands, 2017 on 2nd draft RME).”

Netherlands 67 According to IPEN, companies in Canada and Norway do not require an exemption for this use anymore (comment IPEN 2017).

Possibly Canada and Norway can confirm this.

Netherlands 69 Text: According to IPEN, more than 100 countries agreed that environmentally persistent pharmaceutical pollutants are a global emerging policy issue in the SAICM process and this issue should be closely examined before considering exemptions (comment IPEN 2017).Comment: Suggest using the SAICM text here.

Edited.

Netherlands 74 What to conclude here? Derogation for spare parts for all applications? Or no exemption at all? Or for a transitional period? And is it technical feasible to identify PFOA in spare parts?

Conclusions for spare parts were adjusted according to the comments received. Conclusions can be found in (the adjusted old) para 181 (for

spare parts for equipment used to manufacture semiconductors: “time limited or non-time limited exemptions could be considered for equipment used to manufacture semiconductors, their replacement and spare parts and related infrastructure”)

And in a new para below (old) para 191 (for spare parts in the automotive sector: “an exemption for automotive service and replacement parts could be considered under the Stockholm Convention, however, more information on specific substances and sound justification would be required.”).

Netherlands 77 See remark in para 41. See response to comment on para 41, Table 3

Netherlands 80 Time limited? Edited (not time limited)

Netherland 81-96 From general comments:Chapter 2.2.2. on Costs and benefits of implementing control measures focuses mainly on the situation in Europe. It would be good if the document is lifted to a worldwide level and provides more information for other regions.

Agreement. Specific information on other regions will be appreciated.

Netherlands 82 Text: The estimated substitution costs range from 1.39 to 158.44 million € with a 34.7 million € (central estimate; range from 1.39 to 158.44 million €) for the more realistic

We only have specific information for the EU (difficult to extrapolate to a global scale). Data from other regions

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case (see ECHA, 2015a, Table F.2-6).Comment: In the EU. How to extrapolate to a global scale?

will be appreciated.

Netherlands 85 To my knowledge it is complicated to assess health and environmental benefits, partly due to lack of data. From those perspective first steps towards benchmarking through cost effectiveness has been scrutinized in a study by IVM. Reference is available.

We agree. Could you please provide the IVM reference?

Netherlands 89-92 From general comments:The text of this RME raises the question whether it is possible to identify the most critical uses in terms of amounts released and of environmental effects. Reading paragraphs 89-92 suggest that fire-fighting foam and application in the paper industry may be the ones causing the largest problems. In parallel, industries (I&P Europe and FluoroCouncil) indicate the effects in terms of financial burden. Industry should be invited to indicate the cost and benefits they encountered in phasing out PFOA and in the amounts for the various applications, In what applications are the highest amounts to be expected and are these given priority in the risk management evaluation?

Industry stakeholders could possibly provide specific information.

Netherlands 94 Text: “…significant financial burden…”Comment: Vague terminology

Terminology taken from I&P Europe, 2016b. I&P Europe could possibly provide more specific information.

Netherlands 95 Text: “…reasonable thresholds are required, as are reasonable work-arounds/implementation patterns …”Comment: What is reasonable in this context?

The statement has been included based on a statement from Daikin. Daikin could possibly provide more specific information.

Netherlands 96 Text: The costs of initiatives to protect health and the environment are frequently overestimated in advance and later decline rapidly after the regulation is implemented (IPEN, 2016).Comment: Can this be referenced by industry?

Industry stakeholders could possibly contribute to this statement.

Netherlands 97 Text: These alternatives are mostly short-chain per- and polyfluorinated substances (with less than seven fully fluorinated C-atoms) (ECHA, 2015a).Comment: Industry switched from C8 to C6 technology. And to deliver the same performance more C6 is needed.

Yes. This is stated in other places e.g. in para 143

Netherlands 108, 109 Contradiction in statements. How to proceed? And where to scrutinize in this RME? Information IPEN indicates rejection of C6-technology as alternative.

This important issue needs to be discussed at the POPRC meeting. In the summary of alternatives (see e.g. para 143) it is already indicated that there is an increasing concern about risks related to short-chained PFASs due to their properties and their lower effectiveness. Certainly not all short chain fluorinated compounds are appropriate alternatives.Please note that para 143 has been adjusted according to comments received and contains specific information on concerns about risks related to short-chained PFASs.A conclusive evaluation of alternatives goes beyond the scope of the RME. Guidance on alternatives to PFOA, its salts and PFOA-related compounds will have to be established for future implementation (e.g. similar to what has been developed for PFOS; see

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POPRC.12/INF/15/Rev.1).

Netherlands 111 In this context, it was mentioned that over the life-cycle technical textiles treated with telomer-based C6-chemicals often exhibit 4-8 times more PFC total emissions compared to observed emissions using C8-chemistry (Euratex, 2016).Comment: Remark with a big impact.

The statement is rather general. There may also be C6 alternatives with a better emission profile. More specific information on this issue would be appreciated.Please note that para 111 has been moved to section 2.3.3 under the sub-section “Technical textiles with high performance requirements”.

Netherlands 111 From general comments:Although the RME focuses on PFOA C8 technology, the dossier seems to indicate that the alternative C 6 technology is not an improvement compared to C8 technology, as much more material is needed to reach the same effect. See e.g. para 111. This is a fundamental remark that requires further underpinning, consideration and consultation.

See response to comment on para 97Please note that para 111 has been moved to section 2.3.3 under the sub-section “Technical textiles with high performance requirements”.

Netherlands Section 3 The remarks above will have an impact on the synthesis of information from para 178 and further. Would recommend the drafters to look into the consequences for the synthesis here when changing the paragraphs above.

Edited as far as appropriate

Netherlands 179 See remarks below in the concluding statement. More work is needed to present a recommendation to the COP.

We agree. In particular, the RME can provide a discussion basis for the work to be done at the POPRC meeting.Other comments suggest not to anticipate in the RME whether PFOA, its salts and PFOA-related compounds should be listed in Annex A or B (see comment Sweden on para 203). Such recommendations to the COP can be specified at the POPRC meeting.

Netherlands 180 Text: Some of the exemptions terminated at the end of 2016.Comment: Which ones? And what is the state of play in practice?

Edited (reference to table 3 was inserted)The following exemptions terminated at the end of 2016 (see RME, Table 3):Canada Photo media coatings Water-based inksNorway Photographic coatings for film,

paper or printing plate Adhesives, foil or tape in

semiconductorsThe state of play in practice is outlined in the RME according to the information received and is synthesized in section 3.2.

Netherlands 181 Para 203 presents a time limited exemption. What is the reason to deviate from the EU Regulation? The “could be considered” two lines below is not a convincing argument.

The “could be considered” two lines below is an invitation to the POPRC to discuss a possible time limited exemption on the basis of the information in the RME at its next meeting in order to come to a recommendation to the COP.

Netherlands 184 Vague formulation. An exemption is or is not necessary. “May be necessary” is an invitation for discussion at the POPRC Meeting. See comment on para 181.

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Netherlands 186 Vague statement. Any consequence? “Could be considered” is an invitation for discussion at the POPRC Meeting. See comment on para 181.

Netherlands 186 Please copy the SAICM text here. Edited.

Netherlands 188 Text: Since only one EU company asked for an exemption for a short period of time, this use should be further evaluated before granting an exemption under the Stockholm Convention.Comment: Before COP9

Industry and other stakeholders are already invited to submit relevant information before COP8. It will be up to the POPRC when to provide a recommendation to COP.

Netherlands 189 Text: A transitional period for the use of foams already placed on the market is under discussion.Comment: Update needed at a later stage.

Regarding the EU Proposal an update is needed (see footnote 11). Regarding the discussion on foams already placed on the market see para 77.Note: para 77 has been updated. Germany and Austria support an exemption for “old” foams.

Netherlands 189 Suggestion to replace “could” by “should” Edited

Netherlands 190 EU interpretation is that exemptions are by definition in the Convention time-limited. Without time limit an acceptable purpose is more appropriate.

We agree. Specific exemptions under the convention are time limited. Please see also response to comment on para 7.

Netherlands 192 Very fundamental remark, see my earlier remark above. Agreement. Needs to be discussed at the POPRC meeting.

Netherlands 194 Vague and strange formulation that reads as: we don’t know the risk but action is needed.


Netherlands 195 Text: “…some of the available alternatives are expected to pose lower health risks…”Comment: Which ones? See para 192 where it states that the short chain alternatives might be a regrettable substitution.

See response to comment on para 108, 109

Netherlands 195 PFOA and PFOA-related substances are already replaced with C6 alternatives, see remarks above.

There are also other alternatives than C6 alternatives. It is made clear in the RME that not all alternatives are free of risk. Needs to be discussed at the POPRC meeting.

Netherlands 196 Text: Cost competitive alternatives to PFOA that do not exhibit POPs characteristics have already been implemented in many countries.Comment: Please be specific.

Specific information on the availability of alternatives is given in section 2.3. The text to which the comment refers is an IPEN statement (see para 155) which is repeated in the executive summary (para 9) and here in the synthesis of information. In para 155 we have included specific examples for selected alternatives.

Netherlands 202(b) It should be clear from the recommendation which uses are considered an acceptable purpose and which uses should be regarded as a specific exemption. The COP will not solve such questions.

Agreement. At the POPRC meeting it should be decided how the recommendations should be specified.In the view of the drafter, the decision could be taken considering what has been outlined in the response to the comment on para 7.

Netherlands 203(a) For PFOS an acceptable purpose without time limit in Annex B. What makes the difference?

Because available information indicates that a time limitation could be reasonable (see para 181)

Netherlands 203(b) And what and how to list this in Annex B, as has been done for PFOS?

If a time limitation is considered reasonable for PFOA (see para 181) it is not necessary to list in Annex B

Netherlands 203(e) For PFOS in Annex B, what ist he difference here? A time limitation could be reasonable

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Netherlands 203(f)(g)(h)

The COP will not solve this issue. Agreement. To be discussed at the POPRC meeting.

Norway 4 Suggestion to delete “global” and “globally”.Comments:- still quite many countries left to claim as global- This sentence might not be completely true since there are several places contaminated with PFOA in these countries that contribute to continued emission.

Edited

Norway 41, Table 3 Text: Food packaging, food contact materialsComment: suggestion to add “are exempted from this regulation”

Edited

Norway 63 Comment: Strange to put this under technical textiles, suggest to split into two para.

Not edited. The section relates to the identification of critical uses. In para 63ff information on technical textiles (possibly a critical use) is given. It seems; however, appropriate to also provide information, that for other textiles, e.g. used in outdoor applications, alternatives are available. It is difficult to split para 63.

Norway 64 Suggestion to adjust wording Edited

Norway Production of short chain fluorinated chemicals (related to para 68)

Comment: May I propose: There is an increasing concern among authorities in Europe regarding risks for health and the environment exhibited by short-chain PFASs. Although some of the short-chain PFASs may not formally fill the PBT-criteria, they are extremely persistent, they are very mobile in aquatic systems and in soil, and the increasing use may lead to a continuous exposure that could be of equal concern as bioaccumulation.

We suggest considering this concern in section 2.3.4. where in para 143 the concern is already formulated. Para 143 has been adjusted accordingly.

Norway 88 Suggestion to adjust wording Edited

Norway 92 Suggestion to adjust wording The para has been deleted according to a comment from Switzerland

Norway 134 Text: . None of the fluorine-free foams managed to extinguish the jet A1 fireComment: This might not be completely true.http://www.solbergfoam.com/Foam-Concentrates/RE-HEALING-Foam.aspxhttp://www.zerofiresystems.nl/en/products-and-services/repression/ecopol-100-fluorine-free-foam.htmlhttps://echa.europa.eu/regulations/substituting-hazardous-chemicals/examples-from-real-life/fluorine-free-foams

A sentence has been added: However, fluorine free foams certified to different ICAO levels (required for use at civilian airports) are available on the market (see FFFP, 2017) and are already introduced at airports in practice (see above).The reference (FFFP, 2017) has been added to the list of references.Source 1: certified to ICAO level B and C (see e.g. http://www.solbergfoam.com/Technical-Documentation/Foam-Concentrate-Data-Sheets/ReHealing-Foam/ICAO-Concentrates/RE-HEALING-RF6-F-2011007-3.aspx)Source 2: certified to ICAO level B (see http://www.zerofiresystems.nl/en/products-and-services/repression/ecopol-100-fluorine-free-foam.html)Source 3: certified to ICAO (see http://www.bio-ex.com/products/product/biofilm-fluorosynthetic-afff-foam-concentrate-effective-on-hydrocarbon-fires-9; the link to Bio-Ex can be

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http://www.bio-ex.com/products/product/biofilm-fluorosynthetic-afff-foam-concentrate-effective-on-hydrocarbon-fires-9



http://www.zerofiresystems.nl/en/products-and-services/repression/ecopol-100-fluorine-free-foam.html



http://www.solbergfoam.com/Technical-Documentation/Foam-Concentrate-Data-Sheets/ReHealing-Foam/ICAO-Concentrates/RE-HEALING-RF6-F-2011007-3.aspx






Response

found on the indicated source)Note: ICAO level A or B or C is mandatory for foams used in civilian airports; see http://www.firefightingfoam.com/news/archive/2014/icao-levels-a-b-and-c-whats-the-difference/)

Norway 137 Text: A survey conducted by the Norwegian Food Safety Authority in 2006 concluded that no fluorinated substances were used in fast-food packaging in Norway.Comment: Suggestion to rephrase to: “A survey conducted by the Norwegian Food Safety Authority in 2006 found no fluorinated substances in tested fast-food packaging on the Norwegian market."

The sentence has been deleted according to a comment from Switzerland.

Sweden 2 Proposal to include example: …used in producing e.g. non-stick kitchen ware.

Example included

Sweden 4 Insert when if possible…199X Exact date not quite clear. However, in 2006, the main manufacturers in the US, Europe and Japan agreed on a global phase out of PFOA and related long-chain substances by the end of 2015 (measured from year 2000).

Sweden 4 …increased “production” capacities. Entire sentence has been has been deleted / adjusted

Sweden 5 Indicate year Year added

Sweden Before 7 Consider adding summary info also about uses where alternatives are currently considered available.

Will be too much information for the summary chapter. Presentation of uses without alternatives leads to proposal for exemptions…

Sweden 18 Adjust para 18; include reference, etc. Entire para 18 has been removed from the document.

Sweden 20 Proposal for minor adjustments of para 20 Para 20 has been adjusted also based on other comments received and an available standardized determination method has been included.

Sweden 21 Proposal to shorten Para 21 Para 21 adjusted in accordance to the proposals

Sweden 26 Consider to first list the adopted regulations in Canada and Norway then the EU CLP inclusion, the EU restriction proposal and then the voluntary measures.

Due to other comments received and the available max. number of pages for the final RME, information on the restrictions in Canada and Norway as well as the EU proposal will be moved to the INF document for the final version of the RME. Only the summary table will remain with a link to the INF doc. Therefore, no need to adjust at this point, however we can consider the Swedish proposals in the INF document.

Sweden 26 (g) Ammonium perfluorononanoate (APFO) is regulated in Russia in occupational air with a tentative safe exposure level of 0.05 mg/m3“.

Additional information on exposure level included.

Sweden 33 Consider not to refer to SCCP considerations in the RME for PFOA

The para has been adjusted at several points also based on other comments received. We propose to keep the SCCP example to make clear why Annex C is not recommended.However, we still recommend annex C listing due to “…PFOA formation

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during inadequate incineration”

Sweden 34 Consider if this first sentence could be general and not IPEN specific.

Yes, the sentence can be general. Adjusted.

Sweden 36ff Several proposal to adjust para 36ff Entire para 36 has been adjusted also based on other comments received by parties and observers.

Sweden 37 The EU proposal should be more summarized as the Canadian, Norwegian restrictions. The reader should not have to have read the EU restriction proposal to understand the text – i.a. what para 1 and 2 and para 4…? We tried to make a draft suggestion that should be seen as such, for your further consideration…

Due to other comments received and the available max. number of pages for the RME, information on the restrictions in Canada and Norway as well as the EU proposal will be moved to the INF document for the final version of the RME. Only the summary table will remain with a link to the INF doc. Therefore, no need to adjust at this point, however we can consider the Swedish proposals for adjustments in the INF document.

Sweden 50 Include additional information and proposal for several adjustments

The entire para 50 has been significantly amended also based on information and proposals made by other parties and observers. Information has been combined to reflect all contributions.

Sweden 52 Consider merging with para 57 that contains similar text Similar information from para 59 has been moved to para 52 also based on other comments received. In addition, the resto of para 59 has been removed from the RME.

Sweden 54 Additional source Source has been included in the text and also in the list of references with the link to the relevant information (in Swedish).

Sweden 55 Same information already contained in previous paras of the RME

The entire para has been removed also based on other comments received.

Sweden 59 This recommendation is very similar/identical with the POPRC 6/2 recommendations in the para above. Consider to merge them or to put them together.

As already indicated, information from para 59 have been either moved to para 52 or deleted, also based on other comments received.

Sweden 2.2.1 Suggestion to add “and unavoidable fraction” to the heading

Edited.

Sweden 68 Consider changing this text to address an international restriction instead of regional restriction.

Information is from ECHA 2015 and therefore relates to the EU situation. The sentence has been slightly changed but still addresses the EU.

Sweden 68 PFOA is not used in these processes, but is created as part of a technical mixture that currently are an alternative to PFOA.Therefore the title of the section should to take this into account or this text should be under a separate heading related to unintentional production.

The heading of section 2.2.1 has been adjusted accordingly

Sweden 73 Repletion from first sentence in the para. First sentence has been deleted to avoid repetition. In addition, the entire para has been shortened based on other comments received.

Sweden 80 …all devices… Not further specified which devices. No time limitation has been added based on other comments received.

Sweden 91 Add additional sources Additional sources added in the

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footnote

Sweden 126 Proposal to adjust para 126 Para adjusted in accordance to the proposal.

Sweden 128 Move and adjust sentence: Provided data is not sufficient to conclude on not bioaccumulating (B).

Sentence moved to the beginning of the respective para.

Sweden 137 Same info as below, so can perhaps be merged. Para has been shortened also based on other comments received.

Sweden Chapter 2.3.3

Adjust heading to: No alternative “currently identified” Edited

Sweden 143 Adjust para Edited

Sweden Summary Table in chapter 2.3.4

Adjust table in para 2.3.4. Edited. (except product name)

Sweden 156 Adjust wording in para 156 Wording has been adjusted at several points in para 156.

Sweden 165 Comment by Sweden: “As the RME is about proposing an international restriction it would be useful with a conclusion related to the social costs internationally.”

Agreement that it would be useful to have a conclusion on related to the social costs at international level. The RME is based on the information submitted. Information on social costs at international level will be appreciated.

Sweden 167 Adjust para Relevant information from Sweden slightly adjusted as proposed.

Sweden After 169 Include new para: PFASs, including PFOA, are included in the Swedish Environmental surveillance program and the Swedish health related monitoring program

New para included after para 169 and two new footnotes added with indicated information sources.

Sweden 177 Add sentence to para Further information was provided by also other parties and observers during the preparation of the risk profile.

Sentence added to para 177 as proposed.

Sweden 185 Adjust sentence as: “Production of short chain fluorinated alternatives …can be addressed by establishing appropriate concentration limits in manufacturing.”

Sentence adjusted as proposed. PFOA related substances have been included based on other comments received in this para.

Sweden 199 Include sentence: “Listing of PFOA, its salts and PFOA-related compounds in Annex C is not recommended.”

Listing in Annex C is recommended in order to trigger measures to reduce or eliminate releases from inadequate incineration.

Sweden 203 Suggest not to add proposals for listing in particular Annexes this at this point of developing the RME

Other comments suggest to specifically recommend in the draft RME whether listing should be in Annex A or B and whether an exemption should be a specific exemption or an acceptable purpose (see comments Netherlands on paras 202 and 203).This needs to be specified during the work at the POPRC meeting in order to finalise the RME. In the view of the drafter, the decision could be taken considering what has been outlined in the response to the comment from the Netherlands on para 7.

Switzerland Supplementary document

In addition to its comments, Switzerland has submitted a supplementary document “Additional Information in Relation to the Risk Management Evaluation of PFOA, its Salts, and Related Compounds. Prepared by ETH Zurich on behalf of the Swiss Federal Office for the Environment

The document contains relevant information which is used in several places of the RME. A reference has been added to the list of reference: (FOEN, 2017). It is available via the

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(FOEN)”The supplementary document contains information on the following topics: Chemical identity Transformation/degradation of fluorotelomers to PFOA Formation of PFOA from inadequate incineration of

fluoropolymers BAT/BEP in terms of emission control measures at

industrial and firefighting training sites Alternatives to PFOA in fluoropolymer production Existing regulatory measures in China

SC website: http://chm.pops.int/TheConvention/POPsReviewCommittee/Meetings/POPRC12/POPRC12Followup/PFOAComments/tabid/5950/Default.aspxThe RME refers to the document (FOEN, 2017) in several paras: New para below Table 2 Second para in section 2 (which was

moved here from section 3.1) Third para in section 2 (with

consequences particularly related to a possible Annex C listing e.g. in (old) paras 32 and 33, new para below (old) para 179, new para below (old) para 203)

Two new paras below (old) para 57 (new reference FluoroCouncil 2014b introduced)

One new para below (old) para 129Please note also Info from FOEN, 2017 has been

used to complement para 50 (Reference: FFFC, unknown)

A preliminary assessment of Annex C listing will be considered for the final version of the RME.

Switzerland General Edits below without justification are made with the intention to improve the language without changing the meaning.

Edited as appropriate without mentioning in the response to comments document

Switzerland 1 I think it’s important to point out early on that “PFOA-related compounds” are differently defined under different frameworks. Please modify the footnote to make this point clearer.

Footnote adjusted.

Switzerland 2 Proposal to change the sequence and wording of para 2 Edited

Switzerland 3 Text: “Releases of PFOA from degradation contribute a major share to the releases of PFOA to the environment”Comment: This statement is too general and not correct for all situations, please see Wang et al., 2014a. Please consider to revise it to “in some local environment, e.g., remote inland environments”.

Edited

Switzerland 4 Last two sentences of para 4Comment “These two sentences are too general and not necessarily accurate for all situations. Please consider to change them to "Manufacturers in countries like China, India or Russia have not participated in the Stewardship Programs and thus are not subject to the voluntary phase-out goal of the program.”

Edited

Switzerland 5 Text: “In the EU, it is proposed to totally ban the manufacture, placing on the market and use (including import) of PFOA, its salts and PFOA-related compounds as well as articles containing these substances. That proposal considers exemptions for certain uses.”Comment: “This needs to be updated or in the later versions. I highlighted the rest of the article in yellow”

This will be adjusted in coordination with COM according to the legislative status (see footnote 11)

Switzerland 6 Suggestion to move the sentence “In general, these restrictions are considered technically and economically

Edited

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feasible.” within the para in order to strengthen the logic flow.

Switzerland 7 Please consider to adjust the paragraph orders in the last round to strengthen the logic flow. For example, I would suggest moving this part after the current point 9.

The executive summary is structured according to the outline of the RME in which information on alternative (section 2.3) occurs prior to impacts (section 2.4). This is why para 7 on alternatives is (for the time being) placed before para 8 and 9 on impacts.

Switzerland 8 Please consider to merge the last sentence with the first sentence of the paragraph.

Edited

Switzerland 11 Text: “(5) aqueous film-forming foams used in firefighting application,”Comment: “This is not mentioned in the list in the current paragraph 7. And some of the “critical” uses in the paragraph 7 are not mentioned here. Perhaps add one sentence at the beginning of this paragraph about how these recommendations are developed.”

The first sentence has been completed with “…based on the evaluation of critical uses and the efficiency and efficacy of possible control measures…”Explanation: AFFFs have not been identified as critical use where no alternative exists (alternatives to PFOA containing AFFFs exist; see paras 130 to 134). However, based on socio-economic considerations, AFFFs for professional use are not covered by the restriction approaches in Norway and have been exempted in the Canadian and the EU restriction approaches. Further, Germany proposes to include a transitional period for the use of the “old” foams. This is why an exemption for AFFFs could be considered under the Stockholm Convention (see paras 77 and 189).

Switzerland 17, Table 2 Relevant text: Dissociation constant values indicated in table 2.Comment: There is a new paper showing that it’s definitely below 1.6: Water-to-air transfer of branched and linear PFOA: Influence of pH, concentration and water typeJH Johansson, H Yan, U Berger, IT Cousins - Emerging Contaminants, 2017. Please use the paper and delete para. 17 to avoid further confusion.

Edited in Table 2. Para 17 (and reference De Voogt, 2010) deleted; Reference cited and added to the list of referencesExplanation: Experiments carried out by Johansson et al. 2017 support the conclusion that the pKa of n-PFOA is approximately 0.5.

Switzerland 19 Text: The current extent of global ECF manufacturing is unknown; however, most of the manufacturers may be using the telomerization process nowadays, which mainly results in linear compounds (Wang et al., 2014a)Comment: This is not entirely true, as it has been estimated in Wang et al. (2014a). Please consider to delete this sentence.

Deleted

Switzerland 19 The information here is outdated. Please consider to modify here to “In addition, some manufacturers have used the telomerization process to produce linear PFOA and related compounds. [...] Another study suggests that ECF is still used by some manufacturers in China (Jiang et al., 2015). The global production of PFOA using ECF is still ongoing, whereas most of the manufacturers using telomerization have ceased their production of PFOA and related compounds (Wang et al., 2014a).”

Edited

Switzerland 20 There may have been some ISO standards for certain matrices. Please check that. If so, I would suggest including them here.

Edited. Information on ISO Standard ISO 25101:2009 has been added. The sentence “A standardized method for

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the analysis of presence of PFOA in different matrices is currently not available” has been deleted.

Switzerland 29 Text: Accordingly, the information in the present draft risk management evaluation does not explicitly cover long-chain PFASs so far.Comment: This sentence may need to be updated later. As production, use and alternatives of long-chain PFASs can already be included. Only the socio-economic information cannot be readily included.

Agreement. This will be considered for the final draft.

Switzerland 32(c) Text: PFOA may be listed in Annex C as an unintentional POP to capture PFOA as unintentional impurity in the manufacturing of PFOA-related compounds and some alternatives.Comment: This may need to be updated regarding the potential formation during incineration. The information on the potential formation during incineration is provided in a separate document.

32 (c) adjusted as follows:“PFOA may be listed in Annex C as an unintentional POP to capture potential formation and unintentional release from anthropogenic sources e.g. due to possible unintentional formation during incineration.”

Switzerland 36 Text: The ECHA Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) considered that the proposed restriction on PFOA, its salts and PFOA-related substances is the most appropriate EU-wide measure to address the identified risks, provided that the scope and conditions are modified notably raising the 2 ppb threshold to 25 ppb/1000 ppb.Comment: This may need to be further specified. It’s difficult to understand here.

Adjusted as follows:The ECHA Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC), considered that the proposed restriction on PFOA, its salts and PFOA-related substances is the most appropriate EU-wide measure to address the identified risks, provided that the EU restriction was adjusted to the occurrence in concentrations equal to or greater than 25 ppb of PFOA including its salts or 1000 ppb of one or a combination of PFOA-related substances. These limit values reflect the possible presence of unavoidable impurities and unintended contaminants, and take account of the capabilities of analytical methods (see European Commission, 2017).

Switzerland 39 Text: For aqueous film-forming foams, which would be allowed under the amendments, the development of alternatives has begun and will be monitored.Comment: There are already a variety of alternatives available on the market, as also seen in section 2.3 below. Please consider to delete this outdated sentence.

Deleted.

Switzerland 41, Table 3 Please consider to move this table after the paragraph 28. Table moved together with para 41 (para 41 adjusted accordingly)

Switzerland Paras 43ff Comment: Please consider to add other existing BAT/BEP to control of discharges or emissions. Information on existing BAT/BEP is summarized in a separate document in the submission of comments.

Edited. See e.g. two new paras below para 57.

Switzerland Para 48 The US and Australia have also released their health-based guidance values. The EFSA is updating the EU ones right now and should have a new recommendation this year (EFSA reference: http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2015-00526; https://www.efsa.europa.eu/sites/default/files/contamwgpfasfood.pdf). Please consider to add this information into the draft.

The following information has been added (references added to list of references):The Australian Department of Health determined final health based guidance values for PFOA and PFHxS. These will be used consistently in undertaking human health risk assessments across Australia (see AU Health Dep 2017). The US EPA established health advisory levels for

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PFOA and PFOS in drinking water (see US EPA, 2016). The European Food Safety Authority is currently updating PFOA related health based guidance values.

Switzerland 50 Germany has a similar leaflet as well. Please consider to add it into the draft as well.

Edited

Switzerland 55 Comment: Please consider to merge this paragraph with Para 50.

Edited

Switzerland 57 Please consider to update the reference here to Wang et al., 2014a,c.

Edited as Wang et al., 2014 a, b

Switzerland 59 This repeats the para. 52. Please consider to merge the paragraph here with Para. 52

Repeated information deleted. Other information moved to para 52.

Switzerland 61ff Comment: What’s the definition of “Critical uses”? Please add an overarching paragraph on how “critical uses” have been identified in this section. Please also consider to add a sentence pointing out that for other uses that are not listed here, they are not considered as “critical uses” because no information is identified and/or submitted by stakeholders. In addition, please consider to make a link to Table 3.

We are not aware of a definition of the term “critical uses”.The following para has been added similar to the definition of “critical use” in the RME of Endosulfan:In this risk management evaluation the term “critical uses” means uses for which, there may not be accessible chemical and/or non-chemical alternatives in a country. Uses which are not mentioned in this section are not considered critical. Exemptions proposed or implemented in restriction approaches (see Table 3) give an indication for the identification of critical uses based on technical and socio-economic considerations.See also comment Austria on para 6 and comment Netherlands on section 2.2.1

Switzerland 61 Text: OECD Emissions Scenario DocumentComment: Please provide the specific volume number of the document.

Edited

Switzerland 61 Please consider to use “EU Restriction” instead of “Regulation” in the following text.

Edited

Switzerland 61 Text: Besides, a derogation without time limitation is proposed in photo-lithography processes for semiconductors or in etching processes for compound semiconductors under the EU Restriction (EUROPEAN COMMISSION, 2017)Comment: Please consider to be more specific regarding the derogation.

Available specific information is given in this para.

Switzerland 62 Please specify the information provided “by whom” for “what circumstance”?

It is specified in this para who (SEMI and SIA) provided this information. It was provided in the course of the development of the risk management evaluation (comments on the first draft).

Switzerland 68 Text: The proposed set of thresholds within the EUComment: Which set? Please be more specific here.

Edited

Switzerland 66 Text: There are nearly no emissions, this also included emission paths.Comment: Please consider to be more specific here. This refers to “The BEP”, right?

The text was not changed as suggested, since the respective submission did not provide the required information.

Switzerland 67 Comment: Please consider to merge these two sentences Edited

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Switzerland 68 Text: The proposed set of thresholds within the EU.Comment: which set? Please be more specific

The information on the specific threshold (25 ppb of PFOA including its salts or 1000 ppb of one or a combination of PFOA-related substances) has been added to the para

Switzerland 69 Text: Alternatives have been developed and are available for almost all applications currently using PFOA, its salts and PFOA-related compounds.Comment: This overarching sentence is not needed here. Please consider to delete it.

Edited

Switzerland 75ff Please note that there are already a number of alternatives available.

Edited

Switzerland 82 Text: The estimated substitution costs range from 1.39 to 158.44 million € with a 34.7 million € (central estimate; range from 1.39 to 158.44 million €) for the more realistic case (see ECHA, 2015a, Table F.2-6).Comment: Please specific what “central” means here. Please consider to use more common word such as “mean” or “median”

According to the reference “The central estimates could be considered as illustrating a more realistic scenario; however the information and data received by industry does not really allow identifying an ‘average’ case.”This is already expressed in the text. More common expressions such as average, mean, median are not considered appropriate.

Switzerland 84 Text: EU public consultationComment: I would suggest using a harmonized terminology for this public consultation throughout the draft.

Edited; “EU public consultation” throughout the document.

Switzerland 87 This part repeats the para. 38. Please consider to merge this part with the para 38 above.

The intention here is to emphasize the costs and benefits related to the Canadian restriction approach, whereas in para 38 the approach is explained. The para has been adjusted accordingly in order to avoid repetition.

Switzerland 91 Text: For PFAS derived from a cavern near an old airfield…Comment: It doesn’t read quite right. Please consider to revise the sentence to make the sentence clearer.

This information has been provided by Sweden in their comments on the first draft. The Reference is only in Swedish. Possibly Sweden could check whether the adjusted text is correct: “For PFAS containing water derived from a cavern near an old airfield…”

Switzerland 92 Not sure if this detail is needed here, since PFOA and related compounds are not mentioned.

Para 92 deleted. The para aimed to demonstrate that environmental PFAS contamination can cause significant cost impacts. However, we agree that here neither PFOA nor PFOA related compounds are explicitly mentioned.

Switzerland 94 Text: …, the small remaining critical uses being niche products in markets that IP Europe members anticipate to further declineComment: This part of the sentence is confusing. It’s unclear what the connection of this part with the previous part of the sentence is. Please revise this to make it clearer.

Edited

Switzerland 96 Text: IPEN states, that the phase-out of PFOA that has already occurred indicates that costs of alternatives have not inhibited PFOA substitution.

Sentence deleted to avoid repetition. This first sentence of para 96 repeats the first sentence of para 81.

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Comment: This repeats the first sentence of para. 81. Please consider to merge the two sentences

Switzerland 98 This paragraph is not necessarily correct and doesn’t add any value to this document. Please consider to delete it.

Para 98 has been deleted

Switzerland Section 2.3.2 – Short-chain fluorinated alternatives (para 100 to 112)

How about PFPEs? Please consider to add other known alternatives in the scientific literature (e.g., Wang et al., 2013, 2015, 2016, Holmquist et al., 2016) and those in the PFOS Guidance document.

Based on Wang et al., 2015, information on perfluoropolyethers as fluorinated alternatives have been added to para 97 (introduction of available fluorinated alternatives) and the new headline “Perfluoropolyethers (PFPEs)” was introduced below the headline “Polymerization processing aid”.Additional information on alternative side-chain fluorinated polymers in the textile sector based on Wang et al., 2013 was added below para 100Specific information on available alternatives for PPAs based on Wang et al., 2013 was added below para 124 (see comment Switzerland; para 124-129)Additional information with respect to short-chain alternatives for fire-fighting foams based on Wang et al., 2013 were added above para 130The new references (Wang et al., 2013; Wang et al., 2015) were added to the list of references

Switzerland 102 Text: …even if ≤ C6-based fluorotelomer chemistry is more expensive compared to C8-based products, i.e. higher volumes must be applied to achieve the same technical performance and costs of ≤ C6-based fluorotelomer products are higher (ECHA, 2015a).Comment: This sentence is not logic. Please re-phrase it

Edited

Switzerland 103 Text: Other short-chain fluorinated alternatives for PFOA-related substances are degraded to these acids as well.Comment: This sentence is too general. Please delete it.

Deleted

Switzerland 103 Text: PFHpA and PFHxA are the most abundantly formed PFCAs upon the atmospheric oxidation of 6:2 FTOH.Comment: The atmospheric oxidation and biodegradation of FTOHs have different patterns. Please check if the statement here is correct for the atmospheric oxidation.

Statement correct according to ECHA 2015d

Switzerland 104 Text: Due to microbial degradation and volatilization,Comment: This part is not correct. Please delete it.

Deleted

Switzerland 107 Text: metabolites of 6:2 FTOH are expected to be persistent, to have a lower bioaccumulation potential and a lower toxicity to aquatic organisms compared to PFOAComment: Not sure about this statement. This has not been mentioned anywhere. Please consider to delete it.

This statement is mentioned in ECHA 2015a. Not deleted

Switzerland 109 Text: According to a study provided by FluoroCouncil …Comment: Please consider changing it “According to a Fluorocouncil-sponsored study”, which is a more accurate description of the study.

Edited

Switzerland 109 It is unclear if the suggested studies have been peer-reviewed or not. Some of the assessment results may subject to further discussion and further more detailed

This information has not been put to the background document of this RME since it is related to the para above

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evaluation. However, it is probably outside the scope of this RME. Please consider putting this information in the background document and pointing out if this information has been peer-reviewed or not.

referring to possible POPs characteristics of fluorinated chemical alternatives. However, it is noted: “...considering data from published and unpublished scientific studies..”

Switzerland 110 Text: However, it is admitted that certain textile products formerly treated with PFOA-related substances, which only must fulfill low-performance requirements (e.g. standard clothing, standard outdoor textiles), may be treated by C6-products or even fluorine-free alternatives.Comment: Please consider to change the sentence to “it is admitted that those textile products that must fulfill only low-performance requirements (e.g. standard clothing, standard outdoor textiles), which were formerly treated with PFOA-related compounds, ...”

EditedPlease note that para 110 has been moved to section 2.3.3 under the sub-section “Technical textiles with high performance requirements”.

Switzerland 124-129 Daikin has another alternative. Solvay has a different one as well. Please see Wang et al., 2013.

A new para including information on available alternative polymerization processing aids based on the reference Wang et al., 2013 was added below para 124.

Switzerland 126 Text: C3 Dimer salt… … is presumably not bioaccumulating…Comment: It’s still unclear. Please consider to delete this. See Wang et al., 2015. Environ Int. 75, 172-179. Also for GenX and EEA below.

Deleted. A new para related to the bioaccumulation potential of PFECAs (based on Wang et al., 2015) has been added below para 128.

Switzerland 126 Text: A high to very high mobility to ground water may lead to a lesser bioaccumulation potential than for PFOA.Comment: This sentence doesn’t make sense. Mobility to ground water has nothing to do with the bioaccumulation potential. Please consider to delete this sentence.

Deleted

Switzerland 127 Text: ADONA is … … not bioaccumulatingComment: Again it’s very unclear. Please consider to delete this part.


Switzerland 127 Text: The registration dossier lacks toxicological information relevant to humans.Comment: 3M has more information showing it’s T. See Gordon et al., 2011.

Additional information from Gordon, 2011 has been added to a new para below para 127.

Switzerland 128 Text: EEA-NH4 is considered … …not bioaccumulating.Comment: Again it’s very unclear.


Switzerland 130 Text: … such as perfluorhexane ethyl sulfonyl betaine..Comment: There is one Google hit only, i.e. a POPRC document. Is there a more common name? I’d guess it is a derivative of 6:2 fluorotelomer sulfonate

The wording was taken from the cited reference and therefore not changed

Switzerland 130 Text: dodecafluoro-2-methylpentan-3-oneComment: Please note this is a replacement of halon-based fire extinguisher, and is not a replacement of AFFFs.

This part of the sentence was not deleted in order to not change the meaning of the cited reference

Switzerland 133 Text: .. which makes it a not acceptable alternativeComment: Please re-phrase this part of the sentence

Edited

Switzerland 135 Text: It was noted that alternative treatments of paper and cardboard used in packaging including short-chain telomer-based compounds have been identified, but no further information was provided (IPEN, 2016).

A new para including information on alternatives for surface treatment of food contact material was added below para 135 (based on Wang et al., 2013)

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Comment: More information can be found on the US FDA website (https://www.accessdata.fda.gov/scripts/fdcc/?set=FCN) and Wang et al., 2013.

Switzerland 137 Text: A survey conducted by the Norwegian Food Safety Authority in 2006 concluded that no fluorinated substances were used in fast-food packaging in Norway.Comment: This information is outdated and is contradictory to the next sentence. Please consider to delete it.

Edited

Switzerland Section 2.5.2

Comment: There is much more data available on monitoring, including review papers. The information presented in this section appears to be a little random.

Monitoring data were already covered in the risk profile (see particularly section 2.3 of UNEP/POPS/POPRC.12/11/Add.2. Data in this section are specifically based on Annex F submissions related to the status of control and monitoring capacity.

United Kingdom of Great Britain and Northern Ireland (UK)

General We note that in some parts of the document there are statements like “SEAC proposes to…”. SEAC and RAC are independent ECHA committee that offer opinions for consideration by the European Commission. This should be clarified in the document.

Has been already adjusted in para 36, also based on other comments received. It should be clear now that SEAC and RAC are independent ECHA committee…

UK 20 In the description of analytical methods (e.g. para. 20) there is no mention of achievable limits of detection, or potential for contamination of equipment. This is a relevant consideration as, in the future, there is the possibility that a low POP waste level will be set for this chemical and there may be monitoring requirements.

Edited.

UK 36 We note that paragraph 36 is misleading regarding concentration limits. The value of 2 ppb was a proposal of the original dossier submitter, and the ECHA committees recommended raising it for a variety of reasons. The paragraph needs to be reviewed and state the final limit cited in the EU restriction.

Edited

UK 59 We note that that there is no discussion in the document about the quantity of material that will need to be dealt with as POPs waste, and what the socio-economic analysis (SEA) implications of this will be. Paragraph 59 states about the “proper treatment” of PFOA in landfill leachate, but it is not explained what this means, or the SEA costs of this.

It is not possible at the current state to assess socio-economic consequences at the waste stage since basis information is missing (e.g.: What will be the future Low POP content level? What are concentrations/concentration ranges of PFOA, its salts and PFOA-related compounds in waste?)Relevant information related to this will be appreciated.(See also other comments e.g. Netherlands on para 60)Please note: According to other comments information from para 59 has been moved to para 52. Repetitive information from para 59 has been deleted.

UK 203 In paragraph 203 we note that exemptions for latex printing inks and plasma nano –coatings are not included in the recommendation for time limited exemptions. It is important to note that following industry/stakeholder consultation that the Committee for Socio-economic Analysis (SEAC) accepted that time limited exemptions were appropriate for these applications. It is of note also that some of the uses that were derogated in the EU (e.g. photographic coatings) were niche applications involving

Agreement. To be discussed at the POPRC meeting.

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relatively small amounts. It is not clear whether this is true at a global level – if use is more widespread outside the EU for these applications, and then the reasons for derogation may need to be reconsidered under the Stockholm Convention.

United States of America

26f Suggestion to add:While in general, eligible polymers are exempted from the full US EPA new chemical premanufacture notice (PMN) and review process, effective January 26, 2010 the US EPA rescinded the exemption for polymers containing as an integral part of their composition, except as impurities, certain perfluoroalkyl moieties consisting of a CF3- or longer chain length. This exclusion included polymers that contain any one or more of the following: Perfluoroalkyl sulfonates (PFAS), perfluoroalkyl carboxylates (PFAC), fluorotelomers, or perfluoroalkyl moieties that are covalently bound to either a carbon or sulfur atom where the carbon or sulfur atom is an integral part of the polymer molecule.Reference: https://www.gpo.gov/fdsys/pkg/FR-2010-01-27/pdf/2010-1477.pdf

Edited

Canadian Fuels Association (CFA)

Entire document

Canadian Fuels also understands that draft Risk Management Evaluation (RME) for the subject PFOA consultation includes a number of proposed exemptions for the listing of PFOA to the Convention, including:Aqueous film-forming foams (AFFFs) used in firefighting applicationFor the reasons above, Canadian Fuels support the exemption of AFFFs as proposed in the draft RME.

Edited in para 77.

Canadian Vehicles Manufacturers Association (CVMA)

General (rel. for several paras)

Most relevant excerpts from the CVMA position:…The RME document proposes exemptions for certain sectors but not the automotive industry. As our industry is required to provide service and replacement parts for vehicles already in the market, we request that the RME be revised to reflect the need for auto industry exemptions for service and replacement parts…..The service and replacement parts issue has been raised previously with the Secretariat on decaBDE and now again with PFOA……Under the Stockholm Convention deliberations, we respectfully request that the same approach be undertaken or the creation of a specific exemption for automotive service and replacement parts…

The following changes have been made in the document:Addition to para 74 (related to spare parts):Further, the Canadian Vehicle Manufacturers ‘Association (CVMA) requests specific exemptions for automotive service and replacement parts. According to CVMA, the industry has been proactively phasing out PFOA use for some time. However, service and replacement parts might still contain PFOA. These parts represent a small percentage of PFOA use and will decrease naturally over time as the vehicle fleet turns-over. Automotive manufacturers need to ensure the availability of original equipment and spare parts in order to satisfy customer demand (CVMA 2017).

CVMA GeneralAfter para 191

See comment / request above Based on information received an additional para has been included after para 191 as follows:According to Canadian automotive industry information automotive service and replacement parts might still contain PFOA. These parts are needed to ensure availability of original equipment and spare parts in order to satisfy customer demand. Therefore, specific exemptions are proposed by industry for automotive

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service and replacement parts. These parts represent a small percentage of PFOA use and will decrease naturally over time as the vehicle fleet turns-over. In Canada, the PFOA-related restrictions do not impact the use of automotive service and replacement parts as all manufactured items containing PFOA are currently addressed for the sector (see CVMA 2017). No related exemptions are proposed in the EU. In Norway the prohibitions shall not apply to spare parts for consumer products made available for sale prior to 1 June 2014. An exemption for automotive service and replacement parts could be considered under the Stockholm Convention, however, specification on relevant automotive service and replacement parts as well as sound justification why an exemption would be required though in existing restrictions such an exemption was not considered necessary.

CVMA GeneralConcluding statementpara 203

See above The request for an exemption for automotive service and replacement parts is not mentioned in the concluding statement. In section 3.2 we come to the following conclusion: “An exemption for automotive service and replacement parts could be considered under the Stockholm Convention, however, specification on relevant service and replacement parts and sound justification would be required.”Thus it is concluded, that an exemption could be considered under the condition of further specifications. This is why the exemption is not part of the concluding statement but could become part of it, if the POPRC considers an exemption justified (e.g. upon further specification from industry or due to discussions at the POPRC meeting).

Daikin Request for exemption

Daikin submitted a request for exemption for PFOI reprocessing into PFOB for the production of pharmaceuticals (see document provided by the secretariat of the SC to the drafter on 2.6.2017).

See also comment Japan on para 69.Since PFOB (other than PFOI) is out of the scope of the RME, it could be that (if the process is carried out on the same site as the C6 process) the use could fall under the “closed-system site-limited intermediate” exemption and, that (if it is carried out at another site), it could fall under a possible “transported isolated intermediates” exemption which we now discuss due to the FluoroCouncil Comment on para 68 (see also adjusted draft; search for “transported”) and which we already included in the concluding statement.Could you please provide clearer,

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quantitative information regarding the scale/order of magnitude of this exemption?

FluoroCouncil 5 Text: In the U.S.A., manufacturers of PFOA and PFOA-related chemicals are required since 2015 to notify new uses of these chemicals to EPA in order to allow the evaluation of new uses and, if necessary, take action to prohibit or limit the activity.Comment: Please check for accuracy and include reference to the Federal Register Notice. To the best of our knowledge, this is a proposed rule.

Details are given in para 26f. We do not consider it appropriate to give further details here in the executive summary.In para 26 there is a link to the proposed rule (Footnote 8). We are not aware of a reference to the Federal Register Notice. The drafter would appreciate to obtain a specific reference.

FluoroCouncil 15 Text: Perfluorinated acids, like PFOA, are not degradable in the environmentSuggestion to change to: “Perfluorinated acids (PFCAs), like the long-chain (LC-PFCA) PFOA, are not degradable in the environment” so that the acronym in para 38, 46, 87 is clear.

The text was not changed as suggested since the acronym PFCAs stands for “perfluorocarboxylic acids” and not for “perfluorinated acids” as written in para 15. The acronym PFCAs is later described in para 26(e).

FluoroCouncil 16 (c) (i) Comment on footnote 2 (Du Pont 1998. Technical information: Zonyl fluorochemical intermediates): This document has not been available for years. Please consider deleting this footnote.

The document has been introduced during POPRC12 meeting and we consider it useful to maintain this reference/footnote. If the group has difficulties to access the document, it could be provided.

FluoroCouncil 16 (c) (ii) (iii)

Comment: These examples are confusing:1. (ii) and (iii) can describe raw materials to produce (i) – then 12:2 to 16:2 fluorotelomer compounds are missing in the examples.2. 12:2 to 16:2 fluorotelomer compounds are missing. Inconsistent with examples given under (i).

We agree that (ii) and (iii) can describe raw materials to produce (i) and that further examples such as 12:2 and 16:2 fluorotelomer compounds could be mentioned as further examples. However, the provided examples are not intended to be exhaustive, but to provide examples of substances that can degrade to PFOA. The non-exhaustive list of substances considers further examples of substances in scope (that can degrade to PFOA) in the category “c other” and includes 12:2 and 16:2 fluorotelomer compounds.

FluoroCouncil 19 Footnote 5: This statement may need to be updated. Most manufacturers using telomerization have stopped producing PFOA and related chemicals, e.g., DuPont, Dyneon (Comment Switzerland, 2017).Comment: Signatories of the EPA Stewardship Program (US EPA, 2015) have ceased production but not the entire industry.

Edited (adjusted according to comment from Switzerland on para 19)

FluoroCouncil 20 Please consider changing throughout the document PFCs to PFASs. Check comment on paragraph 28 for further references

Edited

FluoroCouncil 28 The term “PFC” is broad and non-specific and has not been well defined in this document. We suggest to replace the term throughout the document (para 29, 44, 47 and maybe others) with more specific terms, such as PFCA or PFAS and/or long-chain PFCA or PFAS.A definition of long-chain PFCAs has been published by OECD:https://www.oecd.org/ehs/pfc/

Edited. Please note that the OECD definition of long-chain PFCAs has been added to para 28.

FluoroCouncil 36 Text: The EU Committees for Risk Assessment (RAC) The wording of the para has been changed to “The ECHA Committees

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and Socio-Economic Analysis (SEAC)..Comment: These are committees from the European Chemicals Agency ECHA.

for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC)..

FluoroCouncil 39 Text: …and companies expect to eliminate their use by the end of 2016..Comment: Would it be possible to include an update on status for early 2017?

Not sure if information is available.

FluoroCouncil 47 This is the report that assigns the toxicity of PFOA to all perfluorinated substances and sums them. Please add a sentence to explain that in context.

Para 47 clearly states that the limit value is a sum criterion for the presence of 12 PFCs…No need to included further explanations

FluoroCouncil 49 Text: Norway is conducting ongoing remediation of PFAS contaminated soil due to use of AFFF at airports and fire training areas (Norway, 2016).Comment: Please include more details. Are the substance discussed in this document covered in such remediation efforts?

Possibly Norway could provide more details and also specify whether the substances discussed in this RME are covered in such remediation efforts.

FluoroCouncil 50 Since this para describes activities in Sweden, it should be moved to below para 56 to then have a sequence of paras outlining activities in Sweden.

We agree, however, several passages have been moved and adjusted also based on other comments received. We would therefore prefer to consider this (i.e. keeping comments from Member States / countries together) during the drafting of the final version of the RME.

FluoroCouncil 51 This does not seem relevant Sentence has been slightly adjusted based on other comments received. We propose do keep the sentence in the RME as the chapter introduces control measures.

FluoroCouncil 52 Please consider including activities of the Basel Convention and the work the BAT/BEP Group of experts under the Stockholm Convention are performing:http://chm.pops.int/Implementation/BATandBEP/Guidance/Overview/tabid/5121/Default.aspx

Corresponding information has been included (see comment Switzerland on para 43ff)

FluoroCouncil 56 All PFAS’s are not harmful to the environment. Please start the sentence with PFASs as shown. It is more accurate that way.

Has been adjusted as proposed

FluoroCouncil 68 Text: One company illustrated that an unavoidable fraction of PFOA and PFOA-related substances is created when manufacturing short chain fluorinated alternatives. Industry is planning to reprocess the fraction of PFOA and PFOA-related substances back into C6-chemistry. In that case it has to be ensured that PFOA and PFOA-related substances are on-site isolated intermediate and handled under strictly controlled emissionsComment: This is unclear. Is this “one company” that plans to reprocess the fraction of PFOA…, or does it refer to a group of fluorotelomer manufacturers. We ask that the drafters please add more detail here.

Has already been adjusted based on other comments received. “Industry” has been replaced by “The company…” However, in the ECHA 2015a document, it is stated that “Industry is planning…”The drafter is not aware of details going beyond information available from ECHA 2015a.

FluoroCouncil 68 Text: One company illustrated that an unavoidable fraction of PFOA and PFOA-related substances is created when manufacturing short chain fluorinated alternatives. Industry is planning to reprocess the fraction of PFOA and PFOA-related substances back into C6-chemistry. In that case it has to be ensured that PFOA and PFOA-related substances are on-site isolated intermediate and handled under strictly controlled emissions Transport of the substance would not be in line with the aim of the restriction, e.g. might lead to transport outside of the EU,

Comment 1: Edited. It is made clear that this text refers to the EU restriction. The EU exemption applies to transported isolated intermediates and is not relevant in the discussion on on-site isolated intermediates.Other Comments: According to FluoroCouncil, industry may perform reprocessing in another site than the

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and is therefore restricted.Comment 1: This is not clear if this refers to the REACH Restriction on PFOA. The REACH Restriction does not set requirements on the use of the unintentionally produced fraction of PFOA and PFOA-related substances. Further, it should be noted that the Restriction, according to paragraph 4 (c), exempts transported isolated intermediates handled under strictly controlled conditions.Comment 2: REACH does not govern transport.Comment 3: Industry may perform reprocessing in another site than the production site. Therefore, unlike what is stated here, an exemption for the reprocessing is needed.Comment 4: The production of short-chain alternatives is permitted under the REACH Restriction, not on the basis of the thresholds, but on the basis of a specific exemption set forth in paragraph 4 (b).

production site and that therefore an exemption for the reprocessing is needed. It is acknowledged that a corresponding exemption for transported isolated intermediates is foreseen in the proposed EU restriction according to its paragraph 4(c) provided that the conditions in points (a) to (f) of Article 18(4) of the EU REACH Regulation (EC) No 1907/2006 are met (see para 37(d) of the RME).We therefore agree that an exemption could also be considered under the Stockholm Convention for transported isolated intermediates in order to enable reprocessing in another site than the production site. The conditions could be similar to what is proposed under the EU restriction proposal.Accordingly, a new para has been inserted below para 68:“According to FluoroCouncil, industry may perform reprocessing in another site than the production site and that therefore an exemption for transported isolated intermediates is needed (Comments FluoroCouncil on 2nd draft RME). An exemption for transported isolated intermediates without time limit is foreseen in the proposed EU restriction according to its paragraph 4(c) provided that the conditions in points (a) to (f) of Article 18(4) of the EU Regulation (EC) No 1907/2006 are met (European Commission, 2017). An exemption should also be considered under the Stockholm Convention for transported isolated intermediates in order to enable reprocessing in another site than the production site. The conditions could be similar to what is proposed under the EU restriction proposal.”

Please note: several adjustments were made in paras 11, 185 and 203 in order to reflect the issue of transported isolated intermediates

FluoroCouncil 92 The examples given here are for unrelated substances PFHxS and PFOS. Please consider removing this paragraph.

Entire para 92 has been removed also based on other comments received.

FluoroCouncil 96 This para is almost verbatim to para 81. Please consider consolidating into one para.

Yes, para 96 can be deleted as proposed.

FluoroCouncil 105 Please consider adding link to FluoroCouncil's website listing further available studies on fluorotelomer-based short chains: https://fluorocouncil.com/Resources/Research

Edited

FluoroCouncil 121 This paragraph refers to the same product as the one listed in paragraph 123, please combine into a single paragraph.

Edited (and para 123 deleted)

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FluoroCouncil 126 REACH registration dossier includes studies which demonstrate this compound is not likely bioaccumulative in mammalian species (e.g., clearance in primates of 10 to 11h). Please consider including this statement/reference.

Para 126 already includes statements on clearance of C3 Dimer salt in mammalians (e.g. (2-7 days (mouse), 10-11 h (monkey), 4-48 h (rat))

FluoroCouncil 127 Text: The registration dossier lacks toxicological information relevant to humansComment: This is incorrect. The data were published by Steven Gordon in 2011 (Regulatory Toxicology and Pharmacology 59 (2011) 64-80)

This statement has been taken from ECHA, 2015a. A new para providing toxicological data based on the study Gordon, 2011 was added below para 127.

FluoroCouncil 129 Text: An alternative PPA replacing APFO in the manufacturing of fluoropolymers exists.Comment: Not sure which PPA alternative is being referred to

All information concerning the PPA alternative given in the cited reference van der Putte, 2010 are included in para 129.

FluoroCouncil 130 Text: IPEN highlighted that alternatives to the use of PFOA in firefighting foams exist.Comment: PFOA was never “used” in firefighting foams.

The first sentence of para 130 has been deleted

FluoroCouncil 133 Please consider rephrasing as suggested. Edited

FluoroCouncil 143 Text: These concerns are discussed due to the persistence, bioaccumulation and toxicity properties of these substances.Comment: This is an incorrect statement. Suggest to rephrase:“The concern is that these substances display PBT properties but so far that has not been substantiated.” Then include sentences and paragraphs added below starting with January 2014....”Suggested text: In January 2014, Environ International Corporation (now Ramboll Environ), prepared a whitepaper on the persistent organic pollutant (POP) characteristics of five short-chain fluorinated chemicals linked to 6:2 fluorotelomer product chemistry. Results are listed in Table 1.1Ramboll Environ’s January 2014 report considered data from published and unpublished scientific studies related to the POP criteria laid out in Annex D of the Stockholm Convention on Persistent Organic Pollutants, as published by the Stockholm United Nations Environment Programme (UNEP) in 2009Because Annex D of the Stockholm Convention does not provide numerical criteria for the “Adverse effects” criterion, Ramboll Environ’s 2014 report also considered criteria laid out in Annex XIII of the REACH regulations, and guidance issued by the European Chemicals Agency in 20121 for identifying persistent, bioaccumulative, and toxic (PBT) substances.Based on the information available in January 2014, Ramboll Environ concluded that none of the five substances met all of the criteria required to be classified as POPs and none of the substances met more than one criterion.Updates to this report are available and can be downloaded at: https://fluorocouncil.com/Assessment-of-POP-Criteria-for-Specific-Short-Chain-Perfluorinated-Alkyl-Substances. These new updates conclude: “These new data are generally supportive of the primary conclusions reached in Ramboll Environ’s initial report; none of the short chain PFAS evaluated in the study meets the Stockholm Convention POP criteria. In fact, as shown in Table 1.1, none of these substances meet more than one criterion.”

Please note that para 143 has been adjusted based on other comments. Information from Ramboll Environ reports is not added to the summary section 2.3.4 as information from these reports is already given in para 109.

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Citation: Environ, “Assessment of POP Criteria for Specific Short-Chain Perfluorinated Alkyl Substances” (Jan. 2014) available at: http://chm.pops.int/TheConvention/POPsReviewCommittee/Meetings/POPRC9/POPRC9Followup/PFOSSubmission/tabid/3565/Default.aspx).

FluoroCouncil 143 Text: Hence, it remains unclear whether the replacement of PFOA, its salts and related compounds by short-chain fluorinated substances will not be identified as a regrettable substitution.Comment: This statement is speculation and not founded on science or facts. Please consider removing.

Not edited. Para 143 has been complemented with specific information based on other comments demonstrating this statement is not speculation.

FluoroCouncil Summary Table in section 2.3.4(also applies to suggestions of wording changes of para 7 and 63)

Textile sector: Suggestion to change “no” to “some” in the column “appropriate alternative available” and add “Short-chain fluorinated products (e.g. C6-based) can substitute for some of the high performance requirements” in the column “type of alternatives”

Not edited. Based on information provided during the publication consultation no appropriate alternatives for C8-chemistry in the field of professional, technical protective textiles and other advanced textiles (textiles with high performance requirements) are available (e.g. higher amounts of C6-products for initial finishing required, repeated professional reimpregnation after each washing step required in order to meet high safety standards etc.). Please provide specific information for which textiles with high performance requirements C6-alternatives (or shorter) are available.

FluoroCouncil 185 Text: The set of thresholds in the EU restriction proposal is based on information from industry and takes the currently unavoidable fraction of PFOA and PFOA-related substances during production of short-chain alternatives already into account.Comment: The production of short-chain alternatives is permitted under the REACH Restriction, not on the basis of the thresholds, but on the basis of a specific exemption set forth in paragraph 4 (b).One option is for these substances to be re-processed as closed system site-limited isolated intermediates into production of shorter-chain fluorinated substances. The Stockholm Convention states that “Given that no significant quantities of the chemical are expected to reach humans and the environment during the production and use of a closed-system site-limited intermediate, a Party, upon notification to the Secretariat, may allow the production and use of quantities of a chemical listed in this Annex as a closed-system site-limited intermediate that is chemically transformed in the manufacture of other chemicals that, taking into consideration the criteria in paragraph 1 of Annex D, do not exhibit the characteristics of persistent organic pollutants.”[1]

Edited

FluoroCouncil 185 Text: Therefore, an exemption for closed-system site-limited intermediates is not needed for substances listed under Annex A or B of the Stockholm Convention to allow such re-processing.Comment: Industry may perform reprocessing in another site than the production site. Therefore, unlike what is stated here, an exemption for the reprocessing is needed.

Please see previous comment

FluoroCouncil 185 Text: Neither Norway nor Canada or the EU have specific exemptions on the production of short chain fluorinated alternatives in place. An exemption under the Stockholm

Please see previous comment

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Convention is not considered appropriate.Comment: The REACH Restriction, in its paragraph 4 (b), provides a specific exemption for the production of short-chain fluorinated alternatives. An exemption is needed since industry would need to have the possibility to perform the reprocessing in a different site.

FluoroCouncil List of substances

We added the CAS number 9002-84-0 for PTFE (see end of the document tables, last page) and further suggest the additions below, listed in the document just after PTFE in the tables (CAS 25067-11-2, FEP; 26655-00-5, 31784-04-0, 26425-79-6, PFA; 68258-85-5, ETFE; 9011-17-0, 25190-89-0, 56357-87-0, FKM)

The suggested substances with the CAS No 25067-11-2, 26655-00-5 and 31784-04-0 have been added to the appropriate categories of the non-exhaustive list of substances with the suggested acronyms. The substance with the CAS No 26425-79-6 was added with the acronym MFA (Perfluoro Methyl Alkoxy Polymer). The substances with the CAS No 68258-85-5 (ETFE); 9011-17-0, 25190-89-0, 56357-87-0 (FKM) have not been added to the non-exhaustive list of substances as suggested, since, depending on the actual structure, these substances might be within the scope of this RME.

Image and Printing Association Europe (I&P Europe)

Para 40(b) While it is correct that the specific exemptions for photographic coatings applied to films, papers or printing plates in Norway expired in 2016, it should be noted that the Norwegian restriction applies to consumer products only. We do note that this is explicitly mentioned in the document on page 17, section 72.

Yes, it is further stated in section 72 and the para 40 starts with “The Norwegian consumer products regulations amended in 2014 bans the use of PFOA in consumer products…”. So it should be quite clear that the restriction applies to consumer products only. No need for adjustments.

I&P Europe Table 4 While it is correct that no alternatives exist for a small number of critical uses the photo imaging industry has been very successful at developing alternatives for most uses of PFOA-related substances, eliminating more than 95% of the worldwide use since 2000. It is correct that replacements for remaining critical product applications have not been found despite extensive research. Hence a rewording of the second column of the fifth row is suggested, e.g. as follows: “Manufacture of a small number of remaining critical conventional photographic products”.

Table 4 adjusted as proposed

I&P Europe Background doc, Table 6

With respect to the statement made in the third row of the table on page19 I&P Europe notes that the combination of the first three possible alternatives mentioned (i.e. digital techniques, use of fluor telomer-based substances, short chain perfluorinated substances and hydrocarbon surfactants) resulted in the elimination by the photographic industry of more than 95% of the worldwide use of PFOA-related substances since 2000. However the suggested use of silicone products and siloxane compounds are in practice not usable as alternatives in the manufacture of conventional photographic products. This probably also explains the “considerable data gaps” for silicone and siloxane products used on the market for photographic applications – mentioned in the fourth row of the table on page19.

Table 6 in background document adjusted as proposed

International POPs Elimination Network (IPEN)

General Note: The comments from IPEN on the second draft were submitted late. As a consequence it was not possible to consider the specific comments of IPEN on the 2nd draft RME for the 3rd draft version of the document. The specific comments will be considered for the 4th and final draft of the RME. General comments are, however,

Response to comment 1: The existing and proposed approaches do not totally ban or eliminate PFOA and related compounds; all of them provide for exemptions. Therefore the term “restriction approaches” is

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considered here:Comment 1: The repeated references to the term “restriction” approaches demonstrate a bias towards Annex B listing, which is unacceptable in this document. While the term may be applicable to the EU approach, this is not an EU document or process. The document remains far too EU- centric and all references to the competitive advantage of EU industry must be removed.Comment 2: The term “critical use” is not in the SC, and is highly emotive subjective, and should be avoided unless serious public health issues are involved.Comment 3: The RME must include an unbiased evaluation and justification for the need for each possible exemption and a full assessment of safe alternatives. In addition, the specific function PFOA provides for the application that needs to be replaced should be detailed out in order for a fair assessment of alternatives to be made. Not all PFOA properties are useful in all applications.Comment 4: Time limited exemptions should be limited to those that are fully justified, with the provisions of Article 4 in mind.Comment 5: We understand that the consultation firm BiPro has served as a/the drafter for this RME. We find this inappropriate given that the firm has industry clients including 3M, Saint Gobain, and other chemical corporations that may be involved in the manufacture of PFOA and related substances. This calls into question the objectivity of the RME, and in particular, the assessment of the need for exemptions and evaluation of alternatives. It is necessary for impartial POPRC members themselves or independent, unbiased consultants to prepare the RME in order to prevent conflict of interest.Comment 6: It is not corporations that have the right to request exemptions or extensions of exemptions under provisions of the Convention. Concerning extensions beyond the requisite five year period allowed for exemptions, according to Article 4, “The Conference of the Parties may, upon request from the Party concerned, decide to extend the expiry date of a specific exemption for a period of up to five years. In making its decision, the Conference of the Parties shall take due account of the special circumstances of the developing country Parties and Parties with economies in transition.“

considered appropriate to describe the existing approaches and does not demonstrate a bias towards Annex B listing. The approach to decide on Annex A listing versus Annex B listing is described in the response to the comment from the Netherlands on para 7.Response to comment 2: The term “critical use” is used in the explanatory notes to the Annex F form. According to other comments, the term is now explained (see particularly comment Switzerland on paras 61ff).Response to comment 3: In the summary of alternatives (see e.g. para 143; note: adjusted for the 3rd draft) it is already indicated that there is an increasing concern about risks related to short-chained PFASs due to their properties. A conclusive evaluation of alternatives goes beyond the scope of the RME. Guidance on alternatives to PFOA, its salts and PFOA-related compounds will have to be established for future implementation (e.g. similar to what has been developed for PFOS; see POPRC.12/INF/15/Rev.1).Response to comment 4: AgreementResponse to comment 5: Since many years BiPRO provides independent consulting for public and private clients. BiPRO supports the European Commission in drafting the RME. This is done within its mandate from the European Commission in an objective way and particularly on the basis of the information provided by parties and observers and taking due account of the expertise and contributions from the impartial POPRC members.Response to comment 6: Agreement.

IPEN 4 Suggestion to adjust wording Partly edited.

IPEN 4 Text: A similar program existed in Canada. All Stewardship Program participants were successful at virtually eliminating those chemicals globally from facility emissions and product contentComment: This claim must be substantiated, including reference(s) and documentation to verify.

This statement stems from the risk profile which was adopted by the POPRC.

IPEN 5 Suggestion to adjust wording Partly edited.Please note: The existing/proposed approaches all contain exemptions. The substances concerned are not totally banned but restricted. This is why the drafter considers them “restriction approaches”. The term “regulatory approach” is not considered appropriate since in several places we also intend to cover non-regulatory approaches such as

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voluntary approaches.The term “restriction approach” is irrespective of a possible listing under Annex A or B. The approach suggested by the drafter towards listing under Annex A or B is described in the response to the comment from the Netherlands on para 7.

IPEN 5 Text: Since 1 June 2014, it has been prohibited to manufacture, import and export and make available on the market textiles, carpets, other coated consumer products and consumer products that contain PFOA and individual salts and esters of PFOA with exemptions.Suggestion to itemize the exemptions.Comment: These should be itemized.

Specific information on the exemptions is itemized in the document. See particularly Table 3.


IPEN 7 Suggestion to adjust wording The statement in the beginning of the para has been weakened (“The information on the availability of alternatives considering efficacy and efficiency indicates that appropriate alternatives may currently not be available for several uses, namely …”). Other suggestions not edited in order to reflect the content of the RME.

IPEN 7 Justification must be required of industry/Parties for any proposed exemptions with a discussion of viable alternatives and status of implementation of alternatives.

Agreement. Based on the information compiled in the RME and further available and relevant information, the POPRC should discuss and decide whether exemptions are adequate.

IPEN 7 Text: (4) membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatmentSuggestion to delete this partComment: This dispersive use of PFOA should not be allowed, as safe alternatives exist.

Based on the information compiled in the RME and further available and relevant information, the POPRC should discuss and decide whether exemptions are adequate.

IPEN 7 Text: (8) photographic coatings applied to films, papers or printing platesSuggestion to delete this partComment: This should not be listed as a possible exemption because alternatives are available.

Please specify the available alternatives for this use. No appropriate alternative has been identified during the analysis of alternatives within this RME.Based on the information compiled in the RME and further available and relevant information, the POPRC should discuss and decide whether exemptions are adequate.

IPEN 7 Comment on availability of alternatives: Industry stakeholders must be required to provide documentation and justification for any proposed exemptions so that they can be independently evaluated by the POPRC and Parties. They should also provide information on the implementation of safe alternatives.


IPEN 8 Suggestion to adjust wording Please note: PPFOA-related substances do degrade in the environment (to PFOA). Not edited.

IPEN 9 Suggestion to adjust wording Partly edited.Please note: The conclusions made in

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restriction approaches on cost impacts take account of exemptions provided for certain uses.

IPEN 10 Suggestion to delete recommendation to listing in Annex B

Not edited.This should be discussed by the POPRC

IPEN 11 Text: Further, the Committee recommends to consider specifying exemptions for the following uses..Comment: The Committee must independently verify the need, with documentation and justification for any and all proposed exemptions in order to prevent the perpetuation of use and resultant harm associated with continued reliance on PFOA and related substances, POPs compounds that are not degradable in the environment.


IPEN 11 Text: filtration in water treatment, production processes and effluent treatmentComment: Remove this as a possible exemption because this use results in direct releases to the environment and is identified by Sweden as one of two most significant point-sources identified.

Based on the information compiled in the RME and further available and relevant information, the POPRC should discuss and decide whether an exemption for this use is adequate.

IPEN 11 Text: (5) aqueous film-forming foams used in firefighting applicationComment: This is a dispersive use that has resulted in widespread contamination of the environment and human exposure.

Based on the information compiled in the RME and further available and relevant information, the POPRC should discuss and decide whether an exemption for this use is adequate.

IPEN 11 Text: (8) photographic coatings applied to films, papers or printing platesComment: This should not be listed as possible exemption because alternatives are available.

Please specify the available alternatives for this use. No appropriate alternative has been identified during the analysis of alternatives within this RME (see also comment from IPEN on para 7)Based on the information compiled in the RME and further available and relevant information, the POPRC should discuss and decide whether an exemption for this use is adequate.

IPEN 24(b) Text: “… the Canadian restriction approach”Suggestion to change wording to “…the Canadian regulation approach”

Not edited in order to maintain consistent wording. See also response to comment on para 5.

IPEN 26(d) Suggestion to adjust wording at several parts Partly edited.Please note: Information on details, including the phase out date for PFOA in adhesives, foil or tape in semiconductors and for photographic coating of film, paper and printing plates is provided in section 2.2. This is already mentioned in this para.

IPEN 26(f) Suggestion to adjust wording Not edited.

IPEN 26(f) Text: The programme was a voluntary initiative to the substantial phase-out the manufacture and use of PFOA, PFOA precursors and related higher homologue substances (US EPA, 2015).Comment: What remaining uses continue under this Programme?

Possibly the US EPA or stewardship programme participants can provide such information. Relevant information will be appreciated.


IPEN 28 The constant reference to the term “restriction” demonstrates a bias towards Annex B listing which is unacceptable in this document.

The drafter does not agree. Please see response to comment on IPENs suggestion to adjust the wording in

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para 5.

IPEN 29 Suggestion to adjust wording Not edited. Germany and Sweden are preparing a restriction proposal. See https://echa.europa.eu/de/registry-of-current-restriction-proposal-intentions/-/substance-rev/16121/term

IPEN 32 Text: The control measure “prohibition or restriction of production, use, import and export” may be achieved in different ways under the Convention.Suggestion to delete “or restriction”

Not edited. To be decided by the POPRC. If the POPRC decides that exemptions will be listed in Annex B it will be a restriction.

IPEN 33 Suggestion to adjust wording Edited


IPEN 34 Text: According to IPEN, in order to reduce and eliminate emissions of PFOA and PFOA-related compounds, control measures at all life cycle stages need to be in place.Comment: This is a statement which accords to good chemical management

Edited

IPEN 35 Suggestion to adjust wording at several parts Not edited. Please note that scientific committees concluded that exemptions are required. Specific information on the availability of alternatives also according to the EU stakeholder involvement is given in other places in the RME.

IPEN 36 Suggestion to adjust wording at several parts The para has been adjusted according to other comments.

IPEN 36 To shorten this very long document, the drafters might consider only presenting brief summaries of national control actions and placing the details in an addendum document.

Agreement. Details on regulatory restriction approaches have been moved to the background document (also according to other comments).

IPEN 36 and 37 This section is unnecessarily long and overemphasizes the EU.

See previous comment.

IPEN 37 Text: “...a new EU restriction proposal.”Suggestion to change wording to “…a new EU regulatory proposal…”

Not edited. See responses above.

IPEN 38 Text: Further, manufacturers and importers of PFOA and LC-PFCAs and products containing these substances are allowed to apply for a permit to continue their activities after the coming into force of the amendments or after expiry of a temporary exemption.Comment: Have manufacturers or importers applied for such a permit?

Possibly Canada can provide this information.

IPEN 39 Text: Development of alternatives in water-based inks and photo media coatings is underway, and companies expect to eliminate their use by the end of 2016, when the temporary exemption would expire.Comment: This section should be updated as this expiry date has passed. It is important to include information on the status and implementation of alternatives.

Possibly Canada can provide specific information.Note the wording has been slightly adjusted (“…companies expected to …”)

IPEN 40(b) Text: The prohibitions on manufacture and export will not apply until 1 January 2016 to...Comment: This section should be updated as this expiry date has passed.

Edited

IPEN 41 Text: “...described restriction approaches...”Suggestion to change wording to “…described regulatory approaches...”

Not edited. See comments above

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Response

IPEN 41 (Heading of Table 3)

Suggestion to adjust wording at several parts Not edited.Please note that the EU restriction will also be enacted prior to the finalization of the draft RME (see footnote 11)

IPEN 41, Table 3 Text: Adhesives, foil or tape in semiconductors until 2016Suggestion to delete this entry in the row “Exemptions for semiconductor industry” for NorwayComment: Exemptions that have finished should be removed

Note:Please note that Table 3 has been moved below para 28 (see comment Switzerland on para 41, Table 3

IPEN 42 Suggestion to adjust wording Not edited. Regarding the term critical use, please see response to comment Switzerland 61ff.

IPEN 44 Text: The regulatory approach, implemented under the Industrial Chemicals (Notification and Assessment) Act of 1989 requires industry to provide toxicity data for new substances including PFASs or products containing new PFASs being introduced into Australia.Comment: This is not a regulatory process to address PFOA

Yes, but a regulatory approach addressing PFOA-related substances


IPEN 44 Comment on reference “(Comment IPEN 2017)”: Reference it or confirm with Australian government.

Could you provide a specific reference or otherwise could Australia confirm? Feedback will be appreciated.

IPEN 46 Text: The 2010 reduction target was met by all signatories and annual progress reports show that the 2015 target should also be met.Comment: The 2015 target date is long passed. Were the reduction goals met?

Possibly Canada can update on this.

IPEN 47 Suggestion to add: The Danish government has also issued an advisory limit for PFCs in food packaging materials of 0.35 micrograms/cm2 of packaging material, in practice acting as a ban.Reference: https://www.foedevarestyrelsen.dk/Leksikon/Sider/Papir-og-pap.aspx

Edited. Reference added as a footnote.Please note: The reference is in Danish and the drafter was not able to verify the statement.

IPEN 49 Suggestion to adjust wording Already edited according to IPENs comment on para 28

IPEN 50 Suggestion to add: Also, the commercial airports in Sweden have replaced PFAS with non-fluorinated alternatives that are degraded to carbon dioxide and water when used.

Edited. The provided link does not work, this is why we used (Comment IPEN, 2016 on 2nd draft RME) as a reference.

IPEN 59 Suggestion to adjust wording at several parts Edited.Please note that some parts of para 59 have been deleted and some parts have been moved to para 52 (see comment from Austria on para 59)

IPEN 59 The Stockholm Convention requires the use of best available techniques and best environmental practice destruction technologies for wastes containing POPs...it is not simply a recommendation of IPEN.

Agreement

IPEN 60 Suggestion to adjust wording at several parts Edited

IPEN 2.2.1 Suggestion to change the wording of the heading from “Identification for critical uses” to “Identification of important uses”

Not edited. Regarding the term critical use, please see response to comment Switzerland 61ff.

IPEN Section 2.2.1

Information on alternatives should precede a section that claims that alternatives may or may not be available. This order was followed in the PFOS RME and should be used

In other RMEs there is no section on uses where alternatives may not be available. In the present draft RME

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https://www.foedevarestyrelsen.dk/Leksikon/Sider/Papir-og-pap.aspx




Response

in this document. section 2.3.3 provides information on uses where alternatives may not be available and Table 4 in section 2.3.4 summarizes the information on alternatives.

IPEN Section 2.2.1, sub-section “Uses in semiconductor industry”

These sections jump into industry requests for exemptions—but they should first explain what function(s) PFOA provides in the particular use. That is the key to substitution.

This section provides information on uses for which, at present, according to responses received, there may be no suitable alternatives available (to PFOA, its salts and related compounds) or for which social or economic factors justify an exemption. To this end relevant information for the particular uses is provided. Additional specific and relevant information will be appreciated.

IPEN 61 Suggestion to adjust wording at several parts Partly edited

IPEN 61 Text: In former studies, use in semiconductor industry was identified as potentially criticalComment: Please provide references for this claim.

As indicated this statement is based on information provided by SIA.

IPEN 61 Text: SIA surveyed its member companies and found that several companies continue to use PFOA and related chemicals in the photolithography process, a key step in the manufacturing process to produce advanced semiconductors (comment SIA 2017).Comment: This indicates that many do not and that alternatives exist—hence, it is not a critical or important use.

Please provide information on available alternatives for photolithography processes in the manufacture of semiconductors. No appropriate alternative has been identified during the analysis of alternatives within this RME.

IPEN 61 Text: SIA surveyed its member companies and found that several companies continue to use PFOA and related chemicals in the photolithography process, a key step in the manufacturing process to produce advanced semiconductors (comment SIA 2017).Comment: Please provide information on the companies that no longer use PFOA for this function.

No information on the companies that no longer use PFOA for this function is provided in the cited reference.

IPEN 61 Text: This sector is responsible for a very low share of total emissions of PFOA and PFOA-related substances compoundsComment: A reference to validate this assertion is needed here. This is a value statement, not a scientific one. Please provide references or indication why this statement is made - or delete it.

This information has been provided by the Semiconductor Industry Association. The corresponding reference (SIA, 2016) has already been provided in this para.

IPEN 61 Text: Typical control measures are documented in the OECD Emissions Scenario Document.Comment: PFOA is not mentioned in the OECD emissions scenario document on Chemicals Vapour Deposition in the Semiconductor Industry.

The OECD Emissions Scenario Document has been specified and the reference (OECD, 2010) has been added (See also comment from Switzerland on para 61).

IPEN 61 Text: Information submitted by the sector tends to demonstrate that substitution is currently not possible, and that the time frames for substitution are long (10 years).Comment: This contradicts the statement above that "several companies" continue to use PFOA. This means that many others do *not* use it, implying that substitution is possible for this use.

This could be discussed at the POPRC meeting

IPEN 62 Suggestion to adjust wording at several parts It is already made clear that the information is provided by SIA

IPEN 62 Inappropriate to report preferences for Annex A or B of industries with clear commercial interest. Already stated above.

The decision should be left to the POPRC.

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IPEN 62 Text: In addition, SIA also requests that suppliers are provided with an acceptable purpose exemption under Annex B for its uses of PFOA and related compounds in manufacturing “tools” and ancillary equipment.Comment: It is inappropriate to grant unlimited “acceptable purposes“ at the request of industry, especially since they do not provide adequate justification.

The decision should be left to the POPRC.


IPEN 63 Text: Overall, it cannot be fully assessed whether derogation is justified in the professional sector due to data gaps mainly on volumes, specific uses and substances.Comment: Why this statement of doubt when companies say they can substitute in the previous sentence?

As indicated, information is contradicting and very limited

IPEN 63 Suggestion to add the sentence “However, all production in Norway is subject to the substitution principle, which states that if chemicals are used that may harm health or the environment safer alternatives must be used if it does not incur unreasonable costs or disadvantages.” after the sentence “In Norway, only textiles for consumer use are restricted, while textiles for professional use are not covered”Comment: Don´t know if this helps, but the current wording bugged me

Not edited. Is the proposed addition relevant?

IPEN 63 Text: Hence, import, use, sale and offer for sale of textiles containing PFOA, its salts and its precursors are not restricted in Canada.

To our understanding both, existing and new products are not restricted. Possibly Canada can provide clarification.

IPEN 64 Suggestion to adjust wording at several parts Not edited. It is made clear that this is industry information.

IPEN 64 Text: The textile industry as a cross-sectional industry has to fulfill in the segment of professional, technical, protective textiles many different performance standards.Comment: Which ones? The availability of alternatives cannot be evaluated if these standards are not specified.

Performance standards have not been specified by the cited reference. Possibly VTB SWT can provide clarification.Please note that this sentence has been adjusted (see comment from Norway on para 64)


IPEN 65 Text: The transitional period of 6 years would enable ongoing and new projects to deliver results for better performing and environmentally friendlier fluorinated and non-fluorinated polymer alternatives.Comment: The SC has 5 year exemptions not 6

This is a statement by EURATEX and they indicate that a transitional period of 6 years would be required / needed

IPEN 65 Text: . According to EURATEX, continuation of applying C8 chemistry on textile products would maintain the competitiveness of the European technical textile production (Euratex, 2016).Comment: The SC is not there to ensure competiveness of any one country industries. DELETE

Has been deleted


IPEN 66 Text: During the textile refinement, the minimization of emissions is a common practice.Comment: Please provide data or delete. This is not an industry PR pamphlet.

This statement has been taken from the Annex F information provided by The Confederation of the German Textile and Fashion Industry. Could The Confederation of the German Textile and Fashion Industry confirm? Feedback will be appreciated.

IPEN 66 Text: As the technical textiles are produced in the EU, The text has been adjusted (see

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respecting the BEP, the industry claims that the amounts of emissions are close to zero.Comment: Evidence and reference needed here.

comment Austria on para 66).

IPEN 66 Text: There are nearly no emissions, this also includes emission paths after production such as domestic washingComment: Evidence and reference needed here.

The text has been adjusted (see comment Austria on para 66).

IPEN 66 Text: Therefore, an exemption for professional, technical and protective textiles, which must meet durable repellency performance standards, is considered indispensable.Comment: Please describe what specific technical textiles are being referred to.

The cited reference has not provided further details on specific technical textiles.Please note that footnote 15 defines the term “technical textiles with high performance requirements.”

IPEN 67 Suggestion to adjust wording from “). According to IPEN, companies in Canada and Norway do not require an exemption for this use anymore (comment IPEN 2017). The Norwegian restriction, however, only applies to consumer products and does not restrict PFOA use in inks for professional use/printers.” to Companies in Canada and Norway do not require an exemption for this use anymore (Norway, Canada 2017) while the Norwegian restriction only applies to consumer products and does not restrict PFOA use in inks for professional use/printers

Not edited. The first sentence has been taken from a comment of IPEN on the 1st draft of this RME and thus the reference has not been changed.With regards to the terms “restriction” and “regulation” please also see the response to the comment from IPEN on para 5.

IPEN 68 Suggestion to adjust wording This part of para 68 has already been adjusted based on other suggestions.

IPEN 69 Text: According to chemical industry, alternatives have not been developed for all pharmaceutical and some other highly specialized chemicals which use PFOA related chemicals as their raw material and/or processing media and which have social-economic benefit in particular performance standards (FluoroConcil, 2016a).Comment: Please specify. It is impossible to evaluate existing alternatives without the details of the function PFOA has in these uses.

The cited reference has not provided further details. Possibly FluoroCouncil can provide further information. Feedback will be appreciated.

IPEN 69 Suggestion to adjust text to “According to SAICM Resolution IV/2, more than 100 countries recognized the potential adverse effects associated with exposure to environmentally persistent pharmaceutical pollutants on human health and the environment, and the need to protect humans and ecosystems and their constituent parts that are especially vulnerable (SAICM/ICCM. 4/15).”Comment: Check the SAICM documentation

This part of para 69 has already been adjusted (see comments of Netherlands and Japan on para 69) and the footnote 17 referring to SAICM has been added.

IPEN 70 Suggestion to add the sentence “Digital imaging is replacing the need for PFOA in this use and the transition is occurring rapidly” in the beginning of para 70.

Not edited. The transition towards digital imaging has already been mentioned in this para.With respect to digital imaging please also see the response to the comment from IPEN on Table below para 144

IPEN 70 Suggestion to change the terms “critical applications and “critical uses” to “important applications” and “important uses”

Not edited. With respect to the term “critical use” please also refer to the response to the general comment from IPEN (comment 2) and the responses to the comment from Switzerland on paras 61ff.

IPEN 70 Text: Although replacements do not currently exist for the remaining few critical applications, further reduction in use of these substances is anticipated as the transition continues towards digital imaging.Comment: Please specify. It is impossible to evaluate existing alternatives without the details of the function

The cited reference has not provided further details. Possibly I&P Europe can provide further information. Feedback will be appreciated.

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Response

PFOA has in these uses.

IPEN 71 Suggestion to adjust wording at several parts Not edited. The wording has been taken from the cited reference (I&P Europe, 2016a) and thus not been changed.With respect to the term “critical use” please also see the response to the general comment from IPEN (comment 2) and the response to the comment from Switzerland on paras 61ff.

IPEN 72 Suggestion to adjust wording from “EU restriction proposal” to “EU regulatory proposal”

Not edited. Please also see the response to the comment from IPEN on para 5.

IPEN 73 Suggestion to adjust wording at several parts Partly edited.

IPEN 73 Text: During the Public Consultation on the SEAC draft opinion this stakeholder announced that the transition would take longer than initially foreseen, and an extension of the transitional period to 6 years was requested.Comment: For the purpose of transparency, this stakeholder should be identified. A reference and documentation are needed to substantiate this assertion.

This part of para 73 has been deleted (see comments from Austria and Sweden on para 73).

IPEN 73 Suggestion to delete “Only one company provided a confidential SEA that suggests significant economic impact in case sufficient time is not allowed to switch to alternatives (ECHA, 2015a). On this basis, for plasma nano-coating time limited derogation (6 years after entry into force of the Regulation) is proposed in the EU (EUROPEAN COMMISSION, 2017”.

Partly edited. The paragraph has been shortened based on other comments (see comments from Austria and Sweden on para 73).

IPEN 74 Text: According to their comments, in the absence of derogation, those spare parts would have to be destroyed, which would represent an economic loss for EU manufacturers.Comment: This is not relevant in the case of the Stockholm Convention listing

This could be discussed at the POPRC meeting.

IPEN Section 2.2.1, sub-section “Firefighting foams”

It is essential to take all measures possible to eliminate this dispersive use of PFOA as quickly as possible in favor of non-fluorine based and safe alternatives. If an exemption is granted for this use, it should be time limited to a maximum of 5 years and safe alternatives implemented that preclude the need for continued use of PFOA in firefighting foams.

Ok, noted. In the concluding statement we propose whether time limited or non-time limited exemptions should be granted without indicating the exact duration. This should be discussed and agreed on international level.


IPEN 75 Suggestion to add the sentence “However, comments were also submitted that showed the availability of alternatives.” In the end of para 75

Not edited. However, a new para above para 75 referring to the availability of alternatives has been added.


IPEN 76 Suggestion to add the sentence “In Canada, this limit is 10 ppm for aqueous film forming foam.” in the end of para 76

Sentence included as proposed at the end of para 76.


IPEN 77 Suggestion to change the sentence “In Canada, a specific exemption is given to aqueous film-foaming foams used in firefighting applications (Canada 2016c)” to “In Canada, a specific exemption is given to aqueous film-foaming foams used in firefighting applications, but with a concentration limit of 10 ppm (Canada 2016c).”

This is now already stated at the end of para 76, so no need to repeat again.

IPEN 77 Suggestion to add a new para below para 77 including a Not edited in order to avoid repetition.

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Response

new footnote: In Sweden, non-fluorinated alternatives are used at all commercial airports.

This topic has already been mentioned in section 2.3.2, subsection “Firefighting foams”.

IPEN 79 Text: In the specific case of implantable medical devices, a manufacturer requests a transitional period of 15 years (ECHA, 2015c).Suggestion to delete this part of para 79Comment: It is not corporations that have the right to request exemptions or extensions beyond the specified five years under provisions of the Convention. Concerning extensions beyond the requisite five year period allowed for exemptions, according to Article 4, “The Conference of the Parties may, upon request from the Party concerned, decide to extend the expiry date of a specific exemption for a period of up to five years. In making its decision, the Conference of the Parties shall take due account of the special circumstances of the developing country Parties and Parties with economies in transition.”

“15 years” have been deleted. It is now stated that one company requested a longer transitional period.As already stated previously, in our concluding statement only an indication will be given whether time limited / not-time limited exemption is proposed without further specification of duration. This should be further discussed on international level.

IPEN 80 Text: Within the EU restriction proposal, a time- limited derogation (15 years after entry into force of the Regulation) is proposed for medical devices other than implantable medical devices within the scope of Directive 93/42/EEC.Comment: Please specify. It is impossible to evaluate existing alternatives without the details of the function PFOA has in these uses.

All relevant information from the cited reference (EUROPEAN COMMISSION, 2017) has been added to this para. Further information will be appreciated.

IPEN 80 Text: Norway has an exemption in place for medical devicesComment: What is the time limit on this exemption?

Edited (see also comment from Austria on para 80)

IPEN 81 Suggestion to add the sentence “Finally, costs of environmentally sound disposal of these products is also an important factor to take into account” in the end of para 81

Included and slightly adjusted: “Finally, costs of environmentally sound disposal of products which become waste, is also an important factor to take into account”

IPEN 82 Suggestion to add the sentence “However, these cost estimates does not take the factors listed in the previous paragraph into account” in the end of para 82

Sentence included

IPEN 83 Text: Accordingly, it is assumed that the use of alternatives induces a moderate increase in production costs (0-20%).Comment: Please reference and attribute this assumption to a source.

As indicated this statement has been taken from the cited reference (ECHA, 2015a).

IPEN 84 Text: ...that industry has already invested considerable resources to develop short-chain PFAS in R&D efforts as well as in capital (over 500 million € have been reported, which was also confirmed in the EU Public Consultation).Comment: Reported by whom? Please include a reference and documentation of this assertion.

As indicated this statement has been taken from the cited reference (ECHA, 2015a).

IPEN 85 Suggestion to adjust wording at several parts Partly edited.Please note that statements from the cited references (ECHA, 2015a; Norway 2017) have not been extended or changed on the basis of provided suggestions.

IPEN 87 Text: ...prohibit the manufacture, use, sale, offer for sale or import of PFOA and LC-PFCAs and products containing these substances, unless present in manufactured items.

This part of para 87 has been deleted (see comment from Switzerland on para 87).

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Response

Comment: I think the difference between these two is needed to be clearly clarified as it is essential to the consideration of any exemptions.

IPEN 87 Text: The on-going use, sale, offer for sale, and import of these substances in AFFF used in fire protection applications would be allowed.Comment: For how long?


IPEN 87 Text: A temporary permitted use would be allowed for these substances in water-based inks and photo media coatings until the end of 2016Comment: This time period has expired, so it is necessary to provide information on the current status and effectiveness of this measure in the phasing out of this use.


IPEN 89 Suggestion to adjust wording at several parts Partly editedPlease note that statements from the cited references (Australia, 2016) have not been extended or changed on the basis of provided suggestions.

IPEN 89 Suggestion to add the sentence “In April 2017, two major spills of PFOA (22,000 and 5,000 litres) containing AFFFs occurred at Brisbane airport resulted in government warnings to avoid consuming fish from the area’s waterways.” in the end of para 89

Edited.Please note that the reference (Comment IPEN 2017 on 2nd draft RME) has been added.

IPEN 91 Text: The municipalities have released information that wild caught fish from lakes downstream pollution area should not be eaten too often (Swedish Chemicals Agency, 2013).Comment: Did the warning include an interval period?

No indication of intervals

IPEN 92 Suggestion to adjust wording This para has been deleted (see comment from Switzerland on para 92)

IPEN 93 Text: According to German industry representatives, a ban on fluorinated products leads to a substantial decline in economic and innovation power, which means that German textile companies lose their competitiveness and livelihood irreversibly because of their specialization in the production of highly developed niche products with highest requirements.Comment: Reference to competitive advantage in one country over another is inappropriate for the PFOA RME.

This could be discussed at the POPRC meeting.

IPEN 94 Suggestion to adjust wording at several parts Partly edited. With respect to the term “critical use” please also see the response to the general comment from IPEN (comment 2) and the response to the comment from Switzerland on paras 61ff.

IPEN 96 Suggestion to adjust wording at several parts This para has been deleted (see comment FluoroCouncil on para 96)

IPEN 96 Text: Important points to consider when evaluating the costs of alternatives for any product include: Alternatives with a higher initial purchase cost may actually be cheaper over the life of the product when durability and other factors are taken into account; Mass-production of alternatives can significantly lower their costs; The costs of initiatives to protect health and the environment are frequently overestimated in advance and later decline rapidly after the regulation is implemented (IPEN, 2016).Comment: This is a repetition of an earlier paragraph.

This para has been deleted (see comment FluoroCouncil on para 96)

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Response

IPEN 97 Suggestion to adjust wording from “These alternatives are mostly…” to “These alternatives include..”

This part of para 97 has been deleted.

IPEN 97 Text: An overview of some fluorinated and non-fluorinated alternatives for different industry branches is given in (ECHA, 2015a, Table C.1-1; see INF/6/Add.1; Section 3)Comment: This information should be included in the RME rather than in the INF document.

The overview table has been included in the background document and not in the RME due to page limitations.

IPEN 98 Text: The fact that there are neither fluorine-free alternatives nor alternative methods for some applications.Comment: Which ones? Should be a very limited set, if any.

This para has been deleted (see comment from Switzerland on para 98)

IPEN 101 Suggestion to add the text “A recent study noted that non-fluorinated chemical alternatives can meet water repellency requirements for outdoor apparel. The authors propose that use of PFAS chemistry for outdoor apparel is over-engineering and that significant environmental and toxicological benefits could be achieved by switching outdoor apparel to non-fluorinated chemistry.”

The section of para 100-112 deals with short-chain fluorinated alternatives and thus information on non-fluorinated chemical alternatives is not added here. However, the provided information has been added below para 118 and referenced as (comment IPEN 2017 on 2nd draft RME referring to Hill et al., 2017).


IPEN 105 Text: Risks related to fluorotelomer-based short-chain chemistry are summarized in the background document.Comment: Include a summary of these in the body of the RME, not just in the background document.

This information has been included in the background document and not in the RME due to page limitations.Please note that further information on risks related to fluorotelomer-based short-chain chemistry is given in para 108 and section 2.3.4 (“Summary of alternatives”)

IPEN 106 Text: However, bioaccumulation potential of PFCAs with <7 fluorinated carbons is expected to be lower than that of PFOA (Conder et al., 2008).This reference is 10-years old and outdated. Please include references that have more recent data which confirm or reject the expectation.

References with more recent data are welcome.Please note that additional information on bioaccumulation for PFHxA and PFHx is given in para 109.

IPEN 107 Text: Suggestion to adjust wording referring to the reference (Mitchell et al., 2011)

Not edited. The wording has been taken from (Mitchell et al., 2011) and thus not been changed.

IPEN 108 Suggestion to adjust wording at several parts Partly editedPlease note that the reference (comment IPEN 2017 on 1st draft RME) has been included to para 108)

IPEN 109 Text: According to a study provided by FluoroCouncil…Comment: FluoroCouncil has a vested interest in promoting fluorinated chemical alternatives and their “studies“ should be considered biased unless subjected to independent evaluation, peer review, and publication in peer-reviewed journals.

Comment noted.Please note that the first sentence of para 109 has been changed to “According to a study sponsored by FluoroCouncil considering data from published and unpublished scientific studies...”

IPEN 109 Suggestion to adjust text at several parts Edited

IPEN 109 Suggestion to add “This report and evaluation is not independently verified or published in the peer-reviewed literature. Non-fluorinated substitutes are preferable given the likelihood of continuing harm associated with inherent properties of fluorinated compounds. As noted in the recently published scientific consensus statement on poly- and perfluoralkyl substances: “While some shorter-chain

Not edited since this section deals with “short-chain fluorinated alternatives” and not with “non-fluorinated substitutes” (first part of the suggested text to add). Further, other statements of the suggested text (e.g. “while some shorter-chain fluorinated alternatives

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fluorinated alternatives seem to be less bioaccumulative, they are still as environmentally persistent as long-chain substances or have persistent degradation products. Thus, a switch to short-chain and other fluorinated alternatives may not reduce the amounts of PFASs in the environment. In addition, because some of the shorter-chain PFASs are less effective, larger quantities may be needed to provide the same performance. While many fluorinated alternatives are being marketed, little information is publicly available on their chemical structures, properties, uses, and toxicological profiles. Increasing use of fluorinated alternatives will lead to increasing levels of stable perfluorinated degradation products in the environment, and possibly also in biota and humans. This would increase the risks of adverse effects on human health and the environment… Global action through the Montreal Protocol (United Nations Environment Programme 2012) successfully reduced the use of the highly persistent ozone-depleting chlorofluorocarbons (CFCs), thus allowing for the recovery of the ozone layer. However, many of the organofluorine replacements for CFCs are still of concern due to their high global warming potential. It is essential to learn from such past efforts and take measures at the international level to reduce the use of PFASs in products and prevent their replacement with fluorinated alternatives in order to avoid long-term harm to human health and the environment.” to para 109.

seem to be less bioaccumulative, they are still as environmentally persistent as long-chain substances or have persistent degradation products. Thus, a switch to short-chain and other fluorinated alternatives may not reduce the amounts of PFASs in the environment.”) have already been mentioned in section 2.3.With respect to “peer-review of the study” please see comment from IPEN on para 109 above.

IPEN 110 Text: Industry associations noted that especially in the field of professional, technical protective textiles and other advanced textiles (e.g. for fuel cell separators for e-mobility innovations), no alternatives meeting the high demand by legal requirements and by customers are currently available.Comment: What are the specific properties that are legally required or demanded by customers? The statement that no alternatives are currently available for these uses is not adequately justified.

Properties that are legally required or demanded by customers have not been specified by the cited references. Further information is welcome.Please note that para 110 has been moved to section 2.3.3 under the sub-section “Technical textiles with high performance requirements”.

IPEN 111 Text: It was mentioned by several stakeholders that protective textiles..Comment: Who, what stakeholders & where... this needs to be clarified

The reference (VTB SWT, 2016) has already been provided and no further information for the relevant section has been provided.Please note that para 111 has been moved to section 2.3.3 under the sub-section “Technical textiles with high performance requirements”.

IPEN 113 Text: In some cases, when applying fluorine-free alternatives, quality requirements of professional technical, protective textiles cannot be fulfilledComment: Provide specific information on types and applications for these “professional technical protective textiles.“

The cited reference has not provided further details. Further information will be appreciated.


IPEN 116 Suggestion to delete the sentence “However, some of the identified ingredients seem to be harmful”.

Not edited. This statement has been taken from the cited reference.

IPEN 119 Suggestion to adjust wording at several parts Edited

IPEN 119 Text: However, it is admitted that this technology does not seem to be applied yet applied (Statens Forureningstilsyn, 2004; cited by Poulsen et al., 2005).Comment: These references are 12 years old and the information needs to be updated.

No additional information on this technology is available. Further information will be appreciated.

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IPEN 124 Text: According to FluoroCouncil there are various alternative polymerization processing aids (PPA) used for replacing PFOA in the manufacture of fluoropolymers (FluoroCouncil, 2016a).Comment: FluoroCouncil has a vested interest in promoting fluorinated chemical alternatives and their “studies“ should be considered biased unless subjected to independent evaluation, peer review, and publication in peer-reviewed journals.

Comment notedPlease note that additional information on polymerization processing aids in the manufacture of fluoropolymers based on publications in peer-reviewed journals has been added below paras 124, 127, and 128 and is available in the supplementary document of Switzerland (FOEN, 2017).

IPEN 127 Text: Concerning environmental risks (data were taken from the registration dossier) related to ADONA it was concluded...Comment: Reference is needed here.

The provided information was taken from ECHA, 2015a. This reference has already been provided in para 127.

IPEN 127 Text: The substance will most probably fulfil the P criterion of REACH Annex XIII.Comment: Reference is needed here.

The provided information was taken from ECHA, 2015a. This reference has already been provided in para 127.

IPEN 130 Suggestion to adjust wording of first sentence The first sentence of para 130 has been deleted (see comment from FluoroCouncil on para 130)

IPEN 132 Suggestion to add “This study does not consider the internalized costs of continued reliance on fluorosurfactant foams, including the costs of groundwater remediation, contamination of aquatic environments, subsistence and commercial fishers, and environmental and public health.” in the end of para 132.

Edited and referenced as (comment IPEN 2017 on 2nd draft RME)

IPEN 2.3.3 Suggestion to change wording of heading from “No alternative” to “No current alternative”

The wording of the heading has been changed to “No alternative currently identified” (see also comment from Sweden on 2.3.3)

IPEN 138 Suggestion to change wording from “critical uses” to “important uses”

Not edited. With respect to the term “critical use” please also see the response to the general comment from IPEN (comment 2) and the response to the comment from Switzerland on paras 61ff.

"IPEN 140 Suggestion to change wording from “critical uses” to “important uses”


IPEN 141 Suggestion to change wording from “critical” to “important”


IPEN 141 Text: According to representatives of the semiconductor industry, alternatives for some applications may not be available.Comment: These must be identified.

The cited reference has not provided further details on the availability of alternatives for some applications. Further information will be appreciated.

IPEN 141 Text: …and the industry requires a significant amount of time to identify, test, and qualify substitutes..Comment: Specify time.

The cited reference has not specified the required amount of time. Further information will be appreciated. In the concluding proposal no time indication will be made. This should be discussed at international level.

IPEN 143 Suggestion to adjust wording of last sentence from “Hence, it remains unclear whether the replacement of

Not edited. Please explain why to change the wording.

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PFOA, its salts and related compounds by short-chain fluorinated substances will not be identified as a regrettable substitution.” to “Hence, the replacement of PFOA, its salts and related compounds by short-chain fluorinated substances may be identified as an unacceptable substitution.”

IPEN Table below para 144

Text: High performance requirements (e.g. protective textiles)Comment: Specify use

See last comment from IPEN on para 66

IPEN Table below para 144

Suggestion to add “Digital imaging is replacing the need for PFOA in this use and the transition is occurring rapidly.” to the row “Imaging and printing industry” and to the column “Type of alternatives” and to change “No” into “Yes” in the column “Appropriate alternative available”.

Not edited. It is mentioned that “digital imaging will replace the need for PFOA in photo imaging and the transition is occurring rapidly” (para 187) and that “although replacements do not currently exist for the remaining few critical applications, further reduction in use of these substances is anticipated as the transition continues towards digital imaging” (para 70). Further “...imaging industry is focused on the creation of innovative new digital imaging technologies” (para 94). “However, the industry claims that the surfactant and static control properties of PFOA-related substances are important for the application of coating layers during manufacture of some remaining traditional film products (i.e. products in which the image formation is based on silver halide technology). The industry cannot estimate the cost of replacing this use of PFOA-related substances, but notes that these are niche products in markets that will diminish” (para 160).Thus, no alternative for PFOA in the manufacture of conventional photographic products has currently been identified.

IPEN 146 Suggestion to adjust wording at several parts Not edited. The wording has been taken from the cited reference (ECHA, 2015a) and thus not been changed.

IPEN 146 Suggestion to change the wording from “Continuous use and emissions may lead to rising concentrations in the environment and to long-term, large-scale exposure of humans and the environment to PFOA” to “Continuous use and emissions may lead to rising concentrations in the environment and to long-term, large-scale ongoing exposure of humans and the environment to PFOA”Comment: Humans and the environment are already exposed

Not edited. The wording has been taken from the cited reference (ECHA, 2015a) and thus not been changed.

IPEN 151 Suggestion to adjust wording of the last sentence The last sentence of para 151 has been deleted (see comment from Austria on para 151)

IPEN 154 Suggestion to add the sentence “This would have a flow on benefit for indigenous communities highly reliant on native species in their diet.” In the end of para 154

Edited and referenced as (comment from IPEN 2017 on 2nd draft RME)

IPEN 156 Suggestion to change the sentence “In the EU, the use of PFOA and PFOA-related substances..” to “In many countries including the EU, the United States and

Not edited. The wording has been taken from the cited reference (ECHA,

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Australia, the use of PFOA and PFOA-related substances..”

2015a) and thus not been changed.

IPEN 156 Suggestion to change “In Australia, the stigma of being in a contaminated environment due to the legacy use of PFOA-containing AFFFs has led to decreasing property and business values and the loss of income for some land and business owners (see section 2.2.3)...” to “In Australia, the stigma of being in a contaminated environment due to the legacy use of PFOA-containing AFFFs has led to decreasing property and business values and the loss of income for some land and business owners, as well as remediation and ongoing monitoring costs. (see section 2.2.3)…”

Not edited. This section of para 156 refers to a section of para 89 and has thus not been changed.

IPEN 156 Suggestion to change “...costs which will be reduced in the future if PFOA and related substances will be restricted” to “...costs which will be reduced in the future if PFOA and related substances will are prohibited.”

Not edited. See comments from IPEN above related to the wording “restriction”

IPEN 156 Suggestion to add “Finally, it should also be noted that these examples all come from developed countries with high capacity for prevention and remediation. In developing countries or countries in transition such actions would either need external funding and expertize or would not be conducted at all, leading to unacceptable harm to health and the environment.” in the end of para 156

Edited and referenced as (comment IPEN 2017 on 2nd draft RME)

IPEN 159 Suggestion to delete “…which means that European textile companies lose their competitiveness…”

Deleted

IPEN 164 Suggestion to adjust wording Not edited. The wording has been taken from the cited reference (IPEN, 2016) and thus not been changed.

IPEN 176 Suggestion to delete “According to information provided by representatives of the semiconductor industry, the fluoropolymers incorporated into all semiconductor manufacturing equipment produced over the course of the last five years (2011-2015 data) at global level remain a marginal source of PFOA, estimated to be no more than 120 kg per year. Also, the fluoropolymer materials incorporated into facilities-related chemical, gas, and air distribution and control systems for semiconductor manufacturing (related infrastructure) are a marginal source of PFOA, estimated to be no more than 25 kg per year (see comments SEMI 2017).”

Not edited. Please specify why to delete.

IPEN 178 Suggestion to adjust wording at several parte Partly editedSee comments from IPEN above related to the wording “restriction”

IPEN 179 Text: The control measures.Comment: This is not a quote from the SC

Not edited as it is only general options. Please provide suggestions for change

IPEN 179 Text: ..”Prohibition or restriction of production, use, import and export”..Comment: This is not a quote from the SC and should be removed.

Not edited as it is only general options. Please provide suggestions for change

IPEN 179 Text: “...may be achieved under the Convention by listing in Annex A or B. Listing in Annex A or B can be with or without exemptions and/or acceptable purposes.”Suggestion to adjust text to: “...may be achieved under the Stockholm Convention by listing in Annex A with or without exemptions.”


IPEN 180 Suggestion to adjust wording at several parts Partly edited.See comments from IPEN above

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Response

related to the wording “restriction”Please note that the wording of para 180 has already been adjusted based on other comments.


IPEN 183 Text: There are also questions related to membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment.Comment: This is not sufficient information to base an exemption on.

Please note that further information related to membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment is provided in paras 7, 11, 37(c), Table 3 below para 41 and 63.

IPEN 183 Text: “...membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment.”Suggestion to delete “…filtration in water treatment, production processes and effluent treatment.”

Not edited. See comment above from IPEN on para 183.

IPEN 186 Suggestion to delete “In addition, more than 100 countries agreed that environmentally persistent pharmaceutical pollutants are a global emerging policy issue in the SAICM context. An exemption for certain pharmaceutical chemicals and other highly specialized chemicals could be considered under the Stockholm Convention, however, more information on specific substances and sound justification would be required.” and add instead “In addition, according to SAICM Resolution IV/2, more than 100 countries recognized the potential adverse effects associated with exposure to environmentally persistent pharmaceutical pollutants on human health and the environment, and the need to protect humans and ecosystems and their constituent parts that are especially vulnerable (SAICM/ICCM. 4/15).”

Not edited.Please note that pare 186 has been adjusted based on other comments (see comment from the Netherlands on para 186)

IPEN 187 Suggestion to change “critical uses” to “important uses” Not edited. With respect to the term “critical use” please also see the response to the general comment from IPEN (comment 2) and the response to the comment from Switzerland on paras 61ff.

IPEN 187 Suggestion to delete “An exemption could be considered under the Stockholm Convention for photographic coatings applied to films, papers or printing plates.”Comment: This is not justified.

Not edited.With respect to “digital imaging” see comment from IPEN on Table below para 144.

IPEN 188 Suggestion to change “…this use should be evaluated before granting an exemption under the Stockholm Convention.” to “there is no need for an exemption under the Stockholm Convention.”

Not edited. The decision should be left to the POPRC.

IPEN 189 Suggestion to delete “…time limited exemption for the use of PFOA in aqueous film forming foams used in firefighting applications under the Stockholm Convention should be considered..”


IPEN 190 Suggestion to change “An exemption (with or without time limit)…” to “An exemption (with time limit)…”

Not edited. The decision should be left to the POPRC.

IPEN 190 Suggestion to change “…should therefore be considered.” to “could be considered.”

Not edited. See response to the on General comment/position, Concluding statement (para 203) from CVMA related to the wording “could be considered”

IPEN 192 Suggestion to add “Scientists have warned against replacement with other fluorinated alternatives in order to avoid long-term harm to human health and the

Edited and referenced as (comment IPEN on 2nd draft RME referring to Blum et al., 2015)

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Response

environment.” in the end of para 192

IPEN 193 Suggestion to add “…and preventing human exposures” in the end of para 193.

Not edited. The positive impact on human exposure has already been mentioned in the first sentence of para 193.


IPEN 195 Suggestion to adjust wording at several parts Not edited. With regards to the terms “restriction” and “regulation” please see the response to the comment from IPEN on para 5.


IPEN 199 Suggestion to delete “..Prohibition or restriction of production, use, import and export”..”Comment: This is not a quote from the convention

Not edited. See comment above on para 179. Not clear why this should be deleted. If relevant, please specify further.

IPEN 202(a)(b) Suggestion to change “In Annex A with specific exemptions” to “In Annex A with or without specific exemptions” and suggestion to delete “(b) In Annex B with acceptable purposes/specific exemptions accompanied with a specific part of Annex B that details actions”

Not edited. This is the general text of the Convention (para 9 of Article 8 of the Convention).

IPEN 203 Text: The Committee recommends to..Comment: The POPRC should not recommend such a wide number of exemptions, especially dispersive uses for a POPs chemical that never breaks down. Complete, unbiased justification must be made for each proposed specific exemption. No evidence has been provided for its need in water /effluent treatment, or undefined production processes.

This should be discussed and agreed at international level at the POPRC meeting.

IPEN 203 Suggestion to change “The Committee recommends to consider specifying exemptions..” to “The Committee recommends to consider limited specific time-limited exemptions..”

Also non-time limited exemptions are proposed. Therefore the formulation is general to cover both time limited and non-time limited. Again, this should also be discussed at international level.

IPEN 203(d) Suggestion to delete “…filtration in water treatment, production processes and effluent treatment…”

Not edited (see comment from IPEN on para 183)

IPEN 203(g) Suggestion to change “time limit or not (Annex A/B)” to “time limited (Annex A)

See comments above.

IPEN 203(h) Suggestion to delete “(h) Photographic coatings applied to films, papers or printing plates (time limited or not (Annex A/B)”Comment: Digital imaging is replacing the need for PFOA in this use and the transition is occurring rapidly.

Not edited.With respect to “digital imaging” see comment from IPEN on Table below para 144.

SEMI General (rel. to scope)

General comment related to the Scope provided by SEMI:“We would like to emphasize that SEMI members use similar manufacturing technologies to make a wide array of semiconductor and related products. We recommend that the POP-RC explicitly include the words “semiconductors and related electronic devices including microelectronics, photovoltaics, solid state lighting, electronic display, electrical sensors, micro-electrical mechanical systems, and flexible and hybrid electronics“.

According to updated information from the EU, a full derogation is granted for articles which contain semiconductors or compound semiconductors. Therefore, we do not see the need to include an exhaustive list of products in the Annex, as e.g. in 5 years there may be new products made from semiconductors that we do not even think of today. The "flexible hybrid electronics" are a good example; they did not exist 5 years ago.Changes have been made in relevant chapters of the RME

SEMI Para 11 Executive summary has been edited to reflect adjustments …”their replacement and spare parts”

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made in paras 62ff… has been added to para 11

SEMI Para 62 Exemption Request # 1 – Semiconductor manufacturing equipment (ten-year exemption) and their replacement and spare parts (exemption without time limit).Explanations / justification can be found in the document submitted by SEMI to the second draft RME:“An exemption is required because the semiconductor manufacturing equipment sector anticipates technical, cost, and supply chain communication compliance challenges:• Complex Products with a Multi-tiered Supply Chain• Substitution Subject to Lengthy Validation and Requalification ProcessesIn our February 2017 feedback, we provided extensive details about these challenges. Due to these challenges, we anticipate that the equipment sector will need ten (10) years to transition to components made without PFOA.In regards to replacement and spare parts for legacy equipment, we note the following: Semiconductor manufacturing equipment are typically very large and complex, very expensive and have long service lives (often 20 to 30 years), often across a series of owners. The equipment typically requires numerous parts replacement during service life due to anticipated process-related wear-out and preventative maintenance in additional to parts failure.Most alternative spare parts made without PFOA cannot be introduced as drop-in replacements in various types of semiconductor manufacturing equipment. Qualifying spare parts with components made without PFOA can take months to years to requalify for each component.Any interruption in the availability of qualified spare parts could render the equipment inoperable and subsequently functionally obsolete, requiring disposal of the now-obsolete equipment and replacing with “new” in-kind equipment if available.Due to these challenges for spare parts for legacy equipment, we request an exemption without time limit.”

Information has been included into para 62 as: …a time frame of 10 years for transition could be appropriate for manufacturing equipment and related infrastructure. Besides, SEMI proposes a number of additional proposals for exemptions and acceptable purposes. In addition to the manufacturing equipment, an exemption without time limit is proposed for their replacement and spare parts.Note: Despite long service lives, the ultimate objective is elimination. The decision whether the exemption should be time limited or not and a specific exemption or an acceptable purpose in Annex A or B should be left to the POPRC. This is expressed in the adjustments in para 203.

SEMI Para 62 Exemption Request # 2 – Facilities-related chemical, gas, and air distribution and control systems for semiconductor manufacturing fabrication facilities (five-year exemption).Explanations / justification can be found in the document submitted by SEMI to the second draft RME:“In our February 2017 feedback, SEMI requested an exemption for facilities-related distribution and control systems of three (3) years. On further review, we request an exemption of five (5) years to complete a transition, due to:• The extensive global nature of the supply chain both for the polymers from which these articles are made, and of the articles themselves.• The incomplete adoption of the removal of PFOA from the polymers outside of the regions covered by the FluoroCouncil initiatives, where PFOA removal is not yet complete.• The amount of material that can exist in the supply chain.• The extensive qualification times for both by the manufacturer and the end user for changing the polymer

Information has been included into para 62 as: Besides, SEMI proposes a five-year exemption for facility-related chemical, gas, and air distribution and control systems for semiconductor manufacturing fabrication facilities

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for some infrastructure systems, since these materials may be in direct contact with the formulations supplied to the end user, and both parties need to confirm that the new/modified polymers do not negatively impact manufacturing processes.”

SEMI Para 62 Exemption Request # 3 – Chemical container systems for the storage, conveyance, and transport of substances or mixtures (five-year exemption).Explanations / justification can be found in the document submitted by SEMI to the second draft RME:“In our February 2017 feedback, SEMI requested an exemption for chemical container systems for the storage, conveyance, and transport of substances and mixtures of three (3) years. On further review, we request an exemption of five (5) years to complete a transition, due to:• The extensive global nature of the supply chain both for the polymers from which these articles are made, and of the articles themselves.• The incomplete adoption of removal of PFOA from the polymers outside of the regions covered by the FluoroCouncil initiatives, where PFOA removal is not yet complete.• The amount of material that can exist in the supply chain.• The extensive qualification times for both by the manufacturer and the end user for changing the polymer, since these materials are usually in direct contact with the formulations supplied to the end user, and both parties need to confirm that the new/modified polymers cannot contaminate the product contained therein.”

Information has been included into para 62 as: …as well as a five-year exemption for chemical container systems for the storage, conveyance, and transport of substances or mixtures.

SEMI Para 61Para 141

Exemption Request # 4 – We support the recommendation from the POP-RC for an exemption for photolithography process materials for semiconductor manufacturing. We believe that this exemption should take the form of an “Acceptable Purpose” exemption.Explanations / justification can be found in the document submitted by SEMI to the second draft RME:“SEMI believes that it is essential that this exemption take the form of an “Acceptable Purpose” exemption. This is because there are no known substitutes of PFOA for all photolithography applications. Removal of PFOA from all photolithography applications would require some innovation or invention, the likelihood and timing of which cannot be predicted.”And“Based on the response to comments documents, the Stockholm Secretariat working group appears to believe that there are alternatives available for photolithography application. Although it is true that there are alternatives for some PFOA photolithography applications, it is not true that there are substitutes for all photolithography applications in all manufacturing technologies and for all semiconductor-related devices.It is critical to understand that semiconductor production technology is more complex and sophisticated than virtually any other manufacturing technology known. Therefore, a minute variation in chemistry or any other attribute can result in significant changes and performance impacts.Removal of PFOA from all photolithography applications

Information has been included into para 62 and para 141 as: SEMI supports the exemption for photolithography processes for semiconductor manufacturing and highlights that this exemption should take the form of an “acceptable purpose”.However, though the timing is difficult to predict, the ultimate objective is elimination. The decision whether the exemption should be time limited or not and a specific exemption or an acceptable purpose in Annex A or B should be left to the POPRC. This is expressed in the adjustments in para 203.

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would require some innovation or invention, the likelihood and timing of which cannot be predicted. An Acceptable Purpose exemption is necessary.Should stakeholders involved in the Stockholm Convention have questions or concerns regarding our exemption requests, we would be happy to provide clarification.”

SEMI General comment (rel. for para 61, 141, 181…)

Based on the response to comments documents, the Stockholm Secretariat working group appears to believe that there are alternatives available for photolithography application. Although it is true that there are alternatives for some PFOA photolithography applications, it is not true that there are substitutes for all photolithography applications in all manufacturing technologies and for all semiconductor-related devices.

Not quite clear which para is exactly meant, but statements e.g. in para 61, 141 and 181 clearly indicate that alternatives are NOT available for all applications, etc.

SEMI General (rel. for para 181)

Consideration of Exemption 1, 2, 3 and 4 (Summary of risk management in Chapter 3.2)

Based on the 4 proposals for exemptions and explanations given by SEMI, para 181 has been adjusted to cover new information as: “Based on industry information (see SEMI 2017), time limited or non-time limited exemptions could be considered for equipment used to manufacture semiconductors, their replacement and spare parts and related infrastructure (i.e. facilities-related chemical, gas, and air distribution and control systems and chemical container systems for storage, conveyance, and transport of substances or mixtures) as well as for photo-lithography processes for semiconductors or in etching processes for compound semiconductors” .

SEMI General (rel. for para 203)

Consideration of Exemption 1, 2, 3 and 4 (Concluding statement in Chapter 4)

Based on the 4 proposals for exemptions and explanations given by SEMI, the concluding statement has been adjusted to cover new information as:(a) Equipment used to manufacture semiconductors, their replacement and spare parts and related infrastructure (i.e. facilities-related chemical, gas, and air distribution and control sys-tems and chemical container systems for storage, conveyance, and transport of substances or mixtures) (time lim-ited or not (Annex A/B));(b) Photo-lithography processes for semiconductors or in etching processes for compound semiconductors (time limited or not (Annex A/B));

Semiconductor Industry Association (SIA)

General The Review Committee has proposed exemptions for these uses of PFOA and related compounds, and we appreciate the committee’s recognition of the need for exemptions for these uses. The committee proposes that these exemptions be time-limited. As discussed further below, SIA can support a time limited exemption, so long as the industry is provided with sufficient time to allow for the industry to complete the complex and costly process of identifying, qualifying, and introducing into commercial use appropriate substitutes that meet the unique functional and performance needs of the

No need for editing of the RME text as already considered during the first commenting round and also by adjustments made base on comments received from SEMIAppropriate period of time for an exemption should be discussed and agreed on by the POPRC.

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semiconductor industry. Accordingly, we call on the Review Committee to provide a time limitation that meets the needs of the semiconductor industry and provides for the allowance for a renewal of this period as circumstances warrant.

SIA General The draft risk management evaluation appropriately recommends exemptions for photolithography in semiconductor manufacturing and for semiconductor fab equipment. SIA strongly supports the Review Committee’s conclusions in this regard.

No need for editing as already considered during the first commenting round and also by adjustments made base on comments received from SEMIAppropriate period of time for an exemption should be discussed and agreed on

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