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1 | Ref. | Type | Date | Content | Org. country | Org. type | Org. name | Company name confidential | attachment_author | General Comments | 1. Sectors and (sub-)uses | 2. Emissions in the end-of-life phase | 3. Emissions in the end-of-life phase | 4. Impacts on the recycling industry | 5. Proposed derogations | 6. Missing uses | 7. Potential derogations marked for reconsideration | 8. Other identified uses | 9. Degradation potential of specific PFAS sub-groups | 10. Analytical methods | source_document | attachments |
2 | 3834 | BehalfOfAnOrganisation | 2023/03/22 9:25 | Scope or restriction option analysis | Germany | Company | Schreiner Group GmbH & Co. KG | Technical textiles | Part_1.docx | https://www.industrydocuments.ucsf.edu/chemical/docs/#id=zhhv0346 | ||||||||||||
3 | 3843 | Individual | 2023/03/22 18:20 | Scope or restriction option analysis | | | Scope of restriction: The proposed restriction does not differentiate between fluoropolymers (such as PVDF, ECTFE, FEP, PFA and PTFE as wells as Fluoroelastomers - FPM, FFKM, ...) and other PFAS. Fluoropolymers have unique properties that distinguish them from other PFAS and they do not have the environmental and toxicological profiles associated with some PFAS that are of concern. I strongly believe that the restriction proposal should differentiate between the various types of PFAS based of their chemical composition, their toxicological profile and the production method (e.g. the production of fluoropolymers without flourinated production aids). Not all PFAS are the same and there is no scientific basis to regulate them all the same. Benefits to sociaty Fluoropolymers use brings significant benefits along the value chain, making them essential in numerous technologies, industrial processes and everyday products. Their chemical inertness and resistance to harsh conditions, corrosion and extreme temperatures (hot and cold) are unique properties, required in a wide range of applications. Banning Fluoropolymers will make it impossible be successful with key initiatives of the European Union: the green deal, the sustainable development goals, energy transition and the European Chips Act. Request for exemption I request that Fluoropolymers should be exempted from the REACH regulatation. Industrial production of Fluoropolymers can and has to be handled safely in industrial facilities under controled conditions. | Especially when Fluoropolymers are used in industrial applications, they are collected and properly discharged at the end of life (waste incineration above 800 °C ensures that all PFAS are destroyed, discharged in a proper waste disposal site). | The European Chips Act wants to ensure that Euroe is able to produce computer chips on large enough scale to become independet from Asia. Production of computer chips requires ultra pure water and ultra pure chemicals. There is no way aroung using pipes, fittings, vales and vessels made from PVDF, ECTFE, PFA and PTFE in this industry. | Part_1.docx | ||||||||||||
4 | 3849 | BehalfOfAnOrganisation | 2023/03/23 1:45 | Scope or restriction option analysis | Denmark | Company | <redacted> | Yes | SUOMELA Sanna | Please refer to the further outline in the attachment under Section IV. | We understand that an online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. We will submit a more detailed statement in the follow-up to this event and in consideration of the further indications in order to address specific details of the proposal and to emphasize the special interest of our company. | We understand that an online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. We will submit a more detailed statement in the follow-up to this event and in consideration of the further indications in order to address specific details of the proposal and to emphasize the special interest of our company. | We understand that an online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. We will submit a more detailed statement in the follow-up to this event and in consideration of the further indications in order to address specific details of the proposal and to emphasize the special interest of our company. | We understand that an online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. We will submit a more detailed statement in the follow-up to this event and in consideration of the further indications in order to address specific details of the proposal and to emphasize the special interest of our company. | We understand that an online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. We will submit a more detailed statement in the follow-up to this event and in consideration of the further indications in order to address specific details of the proposal and to emphasize the special interest of our company. | We understand that an online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. We will submit a more detailed statement in the follow-up to this event and in consideration of the further indications in order to address specific details of the proposal and to emphasize the special interest of our company. | We understand that an online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. We will submit a more detailed statement in the follow-up to this event and in consideration of the further indications in order to address specific details of the proposal and to emphasize the special interest of our company. | We understand that an online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. We will submit a more detailed statement in the follow-up to this event and in consideration of the further indications in order to address specific details of the proposal and to emphasize the special interest of our company. | We understand that an online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. We will submit a more detailed statement in the follow-up to this event and in consideration of the further indications in order to address specific details of the proposal and to emphasize the special interest of our company. | We understand that an online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. We will submit a more detailed statement in the follow-up to this event and in consideration of the further indications in order to address specific details of the proposal and to emphasize the special interest of our company. | Part_1.docx | https://www.industrydocuments.ucsf.edu/chemical/docs/#id=fxhv0346 |
5 | 3850 | BehalfOfAnOrganisation | 2023/03/23 2:10 | Scope or restriction option analysis | Hungary | Company | <redacted> | Yes | SUOMELA Sanna | Please refer to the further outline in the attachment under Section IV. | We understand that an online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. We will submit a more detailed statement in the follow-up to this event and in consideration of the further indications in order to address specific details of the proposal and to emphasize the special interest of our company. | We understand that an online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. We will submit a more detailed statement in the follow-up to this event and in consideration of the further indications in order to address specific details of the proposal and to emphasize the special interest of our company. | We understand that an online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. We will submit a more detailed statement in the follow-up to this event and in consideration of the further indications in order to address specific details of the proposal and to emphasize the special interest of our company. | We understand that an online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. We will submit a more detailed statement in the follow-up to this event and in consideration of the further indications in order to address specific details of the proposal and to emphasize the special interest of our company. | We understand that an online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. We will submit a more detailed statement in the follow-up to this event and in consideration of the further indications in order to address specific details of the proposal and to emphasize the special interest of our company. | We understand that an online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. We will submit a more detailed statement in the follow-up to this event and in consideration of the further indications in order to address specific details of the proposal and to emphasize the special interest of our company. | We understand that an online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. We will submit a more detailed statement in the follow-up to this event and in consideration of the further indications in order to address specific details of the proposal and to emphasize the special interest of our company. | We understand that an online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. We will submit a more detailed statement in the follow-up to this event and in consideration of the further indications in order to address specific details of the proposal and to emphasize the special interest of our company. | We understand that an online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. We will submit a more detailed statement in the follow-up to this event and in consideration of the further indications in order to address specific details of the proposal and to emphasize the special interest of our company. | We understand that an online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. We will submit a more detailed statement in the follow-up to this event and in consideration of the further indications in order to address specific details of the proposal and to emphasize the special interest of our company. | Part_1.docx | https://www.industrydocuments.ucsf.edu/chemical/docs/#id=gxhv0346 |
6 | 3851 | BehalfOfAnOrganisation | 2023/03/23 9:57 | Request for exemption | Austria | Company | <redacted> | Yes | We are using fluoropolymers for seals | Petroleum and mining: Fluoropolymer applications Food contact materials and packaging (Annex E.2.3.): Industrial food and feed production | Part_1.docx | |||||||||||
7 | 3852 | Individual | 2023/03/23 10:31 | Scope or restriction option analysis | | | The proposed ban encompasses an inconceivable number of material applications. In this sense, a ban on the materials could have far-reaching consequences that are not immediately apparent. Although the benefits of eliminating PFAS are obvious, the disadvantages far outweigh the benefits, and we would end up worse off than we are now. Who is to say that, in addition to the disruption caused by the removal of PFAS, its substitutes would not be even worse? Or (at best) the same? It is critical to develop a strategy that will allow the EU to meet its Green Deal obligations while also implementing a balanced regulatory approach to PFAS. To simply prohibit such a broad range of material usage is a disservice to all, and the approach should be abandoned in favor of a more balanced outcome. | Medicinal products and medical devices. | Part_1.docx | |||||||||||||
8 | 3853 | BehalfOfAnOrganisation | 2023/03/24 10:30 | Scope or restriction option analysis | Germany | Company | ESZ W. Becker GmbH | Good morning, We are a manufacturer of elastomeric construction bearings for static and dynamic requirements and supply construction companies in prefabricated construction, track construction and building construction. We are also a manufacturer of shrink tubes and coating systems made of fluoroplastics for industrial applications, which are used in every conceivable industry. From the baker or butcher who provides his lighting with splinter protection to protect his products, to the sensor manufacturer who wants to significantly increase the life cycle of his electronic components, to the engineer who wants the ideal material for aerospace projects that can withstand all extreme requirements and at the same time has hardly any weight. Fluoroplastics such as PTFE, FEP, PFA and the 35 other materials in this group are unfortunately indispensable and irreplaceable due to their properties. PTFE in particular has an almost universal resistance to aggressive media and can withstand high mechanical or thermal loads at the same time. It is used to protect heating or cooling systems in electroplating, but also to transport fresh water in our passenger planes. It is used in the electric motors of our electric cars, where many sensors have to be permanently protected from oils or greases, but also in medical technology in endoscopic instruments used for operations. New areas of application are added every day, as fluoroplastics have a significantly longer service life compared to conventional plastics, but at the same time are harmless to the body and the environment. In our division for elastomeric construction bearings, we use PTFE in our plain bearings, as they are used in bridge construction, building construction and industrial construction. Due to the outstanding sliding properties of the extremely smooth surface, this material helps to ensure the long-term stability of complex structures. We, as a small medium-sized company that processes fluoroplastics, as well as our customers in the construction, industrial, food & pharmaceutical and automotive sectors, will experience significant impairments and will not be able to keep up with competitors from non-EU countries in the long term. Investments in employees and sustainable production facilities will not pay off and our company will suffer entirely due to the resulting losses. There are many plastics that are harmful to our environment and our health. These should also be tested, strictly regulated or even banned. However, fluoroplastics are not part of this and should not be banned just because they are part of the family. The damage to our further development and our economy will be immense. Thank you for your time. Dennis Olschowka Sales Representative of ESZ W. Becker GmbH | Fluoropolymer applications / Sector as a whole | Part_1.docx | ||||||||||||
9 | 3854 | BehalfOfAnOrganisation | 2023/03/24 12:12 | Hazard or exposure | Germany | Industry or trade association | I&P Europe - Imaging and Printing Association | Nfukuri@ksallc.com | Please see attached non-confidential document. | Our comments apply to use not yet identified in Annex XV restriction report (also see item 6 below) | See two attached documents (one non-confidential version and one confidential version) | Part_1.docx | https://www.industrydocuments.ucsf.edu/chemical/docs/#id=hxhv0346 | |||||||||
10 | 3855 | Individual | 2023/03/24 14:02 | Scope or restriction option analysis | | | We reject this undifferentiated approach of group regulation and urge the responsible government representatives in the Federal Republic of Germany and the European Union to exempt the fluoropolymers recognised by the OECD*) as safe materials ("PLC" = polymer of low concern) as well as the materials necessary for their production from PFAS regulation or use restrictions. Fluoropolymers should be exempted from all regulatory activities under the REACH restriction. Fluoropolymers can be classified as PFAS based on their molecular structure. However, their toxicological and eco-toxicological profile is essentially different from the majority of PFAS substances. Fluoropolymers that meet the OECD criteria of PLC ( = polymer of low concern) are non-toxic, non-bioavailable, non-water soluble and non-mobile molecules and are judged to have no significant impact on the environment and humans. The stability of fluoropolymers can be directly translated into unique and durable performance properties in many applications. For the new megatrends such as green hydrogen, 5G data transmission or e-mobility, fluoropolymers represent the suitable basis on which these innovations become possible in the first place. | sealing elements made of Fluorpolymers and Fluorelastomers | Part_1.docx | |||||||||||||
11 | 3856 | Individual | 2023/03/24 15:42 | | | | Dear ladies and gentleman, in our family we need PFAS products. I absolutely don't understand why the EU irgnored the information which were given before this consultation. I need various PFAS products in my daily life (e.g. as sealing, lubricant or clothes for my daily travel to the work with the bicycle). | Medical applications, technical applications, clothes, sealings, lubricants etc. | In the applications which were given above I have no emissions!!! | From my point the current procedures for waste treatment should be fine. | From my point the current procedures for waste treatment should be fine. | I have not sufficient information about the quantites as a total in my private environment. | Please contact separatley in a transparent atmosphere associations such a Diabetes organizations and chemical associations. It is a shame that comments of these organizations are not consoidered enough prior to such consultation. | It can be assumed that a lot of the products cannot be replaced simply. I am wondering how such a prohibition can be published in the current environment. Asian countries and the US have different political and enomical targets. In consequence they will only replace the production if the profit is high enough. | I will gibe an example. Please ask an diabets patient if PFAS for his medical applications can be replaced. Each Patient is an individual. From my longtime experience I assume that a lot of PFAS applications can not be replaced. | Part_1.docx | ||||||
12 | 3858 | BehalfOfAnOrganisation | 2023/03/27 17:36 | Scope or restriction option analysis | Germany | Company | <redacted> | Yes | Dear ladies and gentleman, to the current proposal of the PFAS ban we would like to disagree. Today the industry and their employees are highly engaged to participate in and to support the iniatives against the climate change. For the industry and their employees this is also a high risk for themselves. The support of this iniatives requires a stable and a longterm planning of supply chains and production facilities (e.g. over the next 30 - 40 years). This longterm planning is not possible, if certain basics are not given. In our business we must be sure, that the transport chain and plant equipment will be available over decades. Sealings, lubricants and other materials cannot be changed simply by other materials. The longterm planning must be safe for the hydrogen and ammonia initiatives. What will happen if a new sealing will fail in a gas application, and who will take the responsiblity? The industry and their employees need a stable legal support. They also need the freedom for creativity. Therefore we kindly ask you to postpone the legislation and to enter with the concerned industry sectors in a closer contact. I kindly over to contact me directly. With best regards Joachim Richter | see above and the offer to contact me | see above and the offer to contact me | see above and the offer to contact me | see above and the offer to contact me | see above and the offer to contact me | see above and the offer to contact me | see above and the offer to contact me | see above and the offer to contact me | see above and the offer to contact me | see above and the offer to contact me | Part_1.docx | ||
13 | 3860 | BehalfOfAnOrganisation | 2023/03/28 14:40 | Information on benefits | United Kingdom | Company | <redacted> | Yes | Sphere Fluidics is an interested party in the PFAS Chemical Restriction proposal and wishes to submit a use-specific derogation on the grounds cited in the attached letter. The derogation requested is for single cell, spheroid and organoid analysis which advances research and discovery of new medicines in the Life Science community. This submission is on the grounds that there are significant socio-economic benefits to the technology the company supplies, the miniscule quantities of PFAS materials used to generate these effects, the controlled laboratory conditions and disposal routes in place and the fact that there are no immediately available substitute materials. | Please see our attached letter. | Part_1.docx | |||||||||||
14 | 3861 | BehalfOfAnOrganisation | 2023/03/29 7:30 | Request for exemption | Korea, Republic of | Company | <redacted> | Yes | It is desirable to be recognized as an 'exempt substance' as a substance essential for product manufacturing without substitute substances throughout the industry. | Part_1.docx | ||||||||||||
15 | 3862 | Individual | 2023/03/29 8:53 | Hazard or exposure | | | In general, as observed in my home, my family homes, my friends etc., we all have Teflon pans or Teflon kitchen aids that are used since years. Those pans are generally slightly damaged by the regular cleaning process and use. While the providers would argue that when new those pans can be safe (not talking here about the PFAS production or recycling), that when correctly used there is no risk, in reality the consumers are exposed daily due to those « damaged » elements. We should so consider in the PFAS study the reality of usage of the produced goods and not a theoretical use. Thanks for reading me. | Daily use of kitchen aid (pans for instance) containing PFAS do expose the population due to leak of PFAS from the products in the cooked food. A study is needed but it can easily be observed in any European family. | Part_1.docx | |||||||||||||
16 | 3863 | BehalfOfAnOrganisation | 2023/03/29 10:55 | Transitional period | Korea, Republic of | Company | <redacted> | Yes | 1 | Part_1.docx | ||||||||||||
17 | 3864 | BehalfOfAnOrganisation | 2023/03/29 16:30 | Request for exemption | Germany | Company | Leistritz Pumpen GmbH | PFAS are high technologie polymeres which are irreplaceable in our products, as there are no alternatives for these properties. The mechanical function combined with the chemical functions are unique and a ban would massively limit the application range of our pumps. Necessary pumping tasks in the food, chemical and petrochemical industries could no longer be fulfilled. The PFAS are used in our products only in the inert state. | PFAS a manadtory to fullfill the function of our pumps. PFAS are used as a coating in the pump an the mechanical and chemical fuction cannot be substitute by an other product. Due to the given boundary conditions no other alternative is available. | Part_1.docx | ||||||||||||
18 | 3865 | BehalfOfAnOrganisation | 2023/03/29 16:34 | Scope or restriction option analysis | Austria | Company | Lenzing Plastics GmbH & Co KG | Regulation covers about 10.000 PFAS materials, but only 38 Fluoropolymers. Our objection is to exclude Fluoropolymers completely of this regulation, as they are polymers of low concern according to OECD scheme. Especially PTFE must be excluded from the ECHA suggestion of regulation. | Medical implants/ devices; Electronics (cables, fuel cell, battery, etc); Sealing; Filtration; Friction Management textiles | 1) Manufacture phase: we convert PTFE polymers in our factory with state of the art technologies under controlled circumstances and continously measured waste water and air quality with no PFAS emission 2) Use phase: e.g.: Due to the outstanding performance of PTFE in terms of biocompatibility and long term stability with excellent long term data, PTFE is used in class 3 permanent implants (artificial heart valves) without any leachables or emissions in use phase. | Scientific report on waste incineration and thermal recycling: Chemosphere Volume 226, July 2019, Pages 898-906: Waste incineration of Polytetrafluoroethylene (PTFE) to evaluate potential formation of per- and Poly-Fluorinated Alkyl Substances (PFAS) in flue gas. Krasimir Aleksandrov; Hans-Joachim Gehrmann; Manuela Hauser; Hartmut Mätzing; Daniel Pigeon; Dieter Stapf; Manuela Wexler | 1) several case studies already proved recyclability of PTFE. (e.g. Upcycling plant Burghausen) 2) we would like to point out, that overall volume of produced PTFE is very low compared to many other chemical substances and materials. Especially when considering only solid PTFE applications and no coatings or other non-solid products the impact is small in terms of quantity (tonnage). 3) The soluble PFAS can and should be strictly regulated, which will reduce relative volumes even more. | All fluoropolymers for essential uses should get permanent derogation, especially following applications: - PTFE components for permanent implant and medical devices - PTFE components for wound management - PTFE components for electronics (cable tape, fuel cell membrane and Ionomers, battery seperator, etc) - PTFE components for efficient sealing devices - PTFE components for filter media - PTFE components for friction management - all other sustainable (emission reducing, energy consumption reducing, lifetime increasing) applications of PTFE components | PTFE and Fluorpolymers are very expansive and difficult to work with in converting. Therefore they are only used when no other alternatives are available. - PTFE components for implants: long term stability and excellent biocompaitiblity combined with flexibility and specific surface properties (low friction) are unique; substitution would lead to worse e.g. artificial heart valves - PTFE components for electronics: EU green deal and digital transformation (5G, etc) will not work without Fluoropolymers. E.g. fuel cell membranes but also cables for high frequency applications (such as sensor cables, Microcoax) - PTFE components for sealing devices: no other material can guarantee long term low emissions (e.g. methan); all alternatives will have shorter lifetime and higher leakage due to lower chemical and thermal resistance. Also friction and therefore power consumption will be higher in all pumps. - PTFE components for filtration: emmission will be higher as materials get destroyed much faster (e.g. hot gas filters in waste incineration plant) ad g) we have 400 employees and a turnover 2022 of 160 Million Euro, which will be totally affected from such a strict regulation. We do not understand that Fluoropolymers are in the same group as soluble PFAS, although they are completely safe and polymers of low concern according to OECD and others. For further details also see studies of: pro-K Industrieverband Halbzeuge und Konsumprodukte aus Kunststoff e.V. Mainzer Landstraße 55 60329 Frankfurt am Main or The European Chemical Industry Council, AISBL Belliard, 40 - 1040 Brussels - Belgium | According to our OEM clients there are no viable technical alternatives for: PTFE components in Medical implants/ devices PTFE components in Electronics PTFE components in sealing devices PTFE components in filtration devices PTFE components in friction management applications | According to our OEM clients there are no viable technical alternatives for: PTFE components in Medical implant / devices PTFE components in Electronics PTFE components in sealing devices PTFE components in filtration devices PTFE components in friction management applications | Part_1.docx | https://www.industrydocuments.ucsf.edu/chemical/docs/#id=hjhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=gjhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=fjhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=zxhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=txhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=sxhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=rxhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=qxhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=pxhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=nxhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=yxhv0346 | ||||
19 | 3866 | BehalfOfAnOrganisation | 2023/03/29 17:20 | Scope or restriction option analysis | Finland | Company | Atolli OY | christian.sundberg | Potential impact on fluoropolymer semifinished products and their applications Our company Atolli Oy is providing low carpon foot print (LCA) pipelines, seals, valves, vessels for chemical and process industry. When building these pipelines, we are using semifinished products made out of PVDF, ECTFE, FEP, PFA and PTFE. These products have app. 5-10 times more lifetime and several times lower carpon footprint (LCA), than metal or any other altenative material in use. These pipelines are in use of chemical industry, battery industry, food and drug industry etc. The draft proposal to restrict PFAS defines PFAS as substances containing at least one fully fluorinated methyl (-CF3) or methylene (-CF2-) carbon atom and aims to ban the production, processing, import and use of PFAS across Europe. The discussion was originally triggered by low molecule, water-soluble and volatile substances, but the proposal for the restriction does not distinguish between fluoropolymers (such as PVDF, ECTFE, FEP, PFA and PTFE) and other PFAS. Thus, from the current perspective, all fluoropolymers would be affected by the restrictions. Our target is to exclude fluoropolymers semifinished products from all regulatory activities under the REACH restrictions. Wery happy to give You more deatails and case studies!!! | Part_1.docx | https://www.industrydocuments.ucsf.edu/chemical/docs/#id=xxhv0346 | |||||||||||
20 | 3867 | Individual | 2023/03/30 12:33 | Scope or restriction option analysis | | | The restriction describes the ban on the manufacture and use of over 10,000 substances, including fluoropolymers such as PTFE. The attempt of singular solution of individual environmental problems (which are important, no doubt) and the disregard /misunderstation of the consequences of these decisions is openly shown with this general prohibition of use. In my view, this general ban does not sufficiently take into account the use of fluoropolymers, within the manufacturing processes of the (chemical) industry. To have highly stable and technically tight compounds is necessary to avoid diffuse emissions (of hazardous substances) to meet current emission restrictions for chemical plants. The fluorinated polymers are urgently needed here precisely because of their material properties (long-term stability, resistance to abrasive media, inert surfaces, ...) to achieve technically tight connections and as inliners for equipment (pipes, containers), a replacement is not available for every type of application. For example I would like to point pharma industry. This application - especially fluoropolymers - contradicts a pragmatic, risk-based approach and endangers both the prosperity achieved in Germany and (and this is the more important aspect for me) the patient's well-being. As a chronically ill person myself, I am dependent on the regular intake of medication and hereby express my concerns about the relocation of chemical drug production to non-European countries. In particular, the corona pandemic has shown massive delivery difficulties. Last but not least, it still should be a goal to preserve jobs in Europe. The question of how European countries and their population want to live and interact with each other socially and socio-economically today and in the future continues to be ignored with such a ban on use and remains unanswered. | I am surprised: I would love to refer to Annex XV (Table 9) for the sector: chemical industry, but this is not possible, since in this table many - from my point of view partly unimportant - sectors (e.g. ski wax) are mentioned, but not the chemical industry as a sector. | up to now emissions in the end-of-life phase (for example) in waste water of chemical plants, didn´t have to be measured, this has to take place first, before there is considered a ban of all fluor-polymers like ptfe. | If we talk about incineration there are specific requirements for emission levels and combustion conditions (temperature, time slots for duration in high temperature areas..) for incineration plants, which meet requirements for safe destroying pfas. | The question is too simple, I would have loved to answer : I dont have specific and assigned information on this topic. Its easy to imagine that for tight joints no substitution up to now is technically available, because it is precisely the material properties criticized within the ban, that are required in a similar way for the production of seals. | Part_1.docx | ||||||||||
21 | 3868 | BehalfOfAnOrganisation | 2023/03/30 12:43 | Information on alternatives | Switzerland | Company | Aseptconn AG | In the pharma and biopharma industry, PVDF, FEP, PFA and PTFE are the only materials for sealing (in this range of conditions, T°, pH, Pression) and are considered topologically safe. We perform toxicological tests (USP CL VI and USP87) as well as leachability tests. There is no other product on the market that can perform the same functions. | Part_1.docx | |||||||||||||
22 | 3869 | Individual | 2023/04/02 11:42 | Hazard or exposure | | | I am against subjecting all PFAS to an undifferentiated restriction. In my company, PTFE and PVDF semi-finished products are machined into individual industrial components. The materials are physiologically harmless and fulfil applications that cannot be fulfilled by any alternative materials in the combination of material requirements in relation to the application. My appeal to the acting bodies is that they take a differentiated view of the situation. An undifferentiated ban will inevitably have negative effects on existential future projects of mankind (energy transition, electrification in the automotive industry, chemical process industry, etc.). The mere persistence of substances is not an acceptable reason to assume that the substance is harmful or dangerous. | Part_1.docx | ||||||||||||||
23 | 3870 | Individual | 2023/04/02 22:31 | Transitional period | | | Because this consultation is hard to access by the average European citizens (like me) I am fearful that most of the comments will not come from them but, rather, from industrials that are interested against restricting PFAS and may propose biased analyses. Because of that fear I encourage the evaluation panel(s) to not obey to a 'law of the majority' in the comments received. Similarly, I as an end-user am definitely favoring the shortest possible transition period, and the minimum number of exemptions. | Part_1.docx | ||||||||||||||
24 | 3871 | BehalfOfAnOrganisation | 2023/04/03 5:36 | Scope or restriction option analysis | Japan | Company | <redacted> | Yes | In industrial inkjet printers, PTFE, ECTFE, PFA, ETFE, and FKM are used in wetted parts such as pipes, valves, and ink pumps through which printing ink passes. The reason is their chemical resistance to printing inks. Use of PTFE, ECTFE, PFA, ETFE, and FKM is essential and cannot be substituted. Therefore, please exempt "industrial inkjet printers". | "5. By way of derogation, paragraphs 1 and 2 shall not apply to:" "x. [industrial and professional use of solvent-based debinding systems in 3D printing until 13.5 years after EiF]; y. [industrial and professional use of smoothing agents for polymer 3D printing applications until 13.5 years after EiF];" | Part_1.docx | |||||||||||
25 | 3872 | BehalfOfAnOrganisation | 2023/04/03 12:09 | Request for exemption | United Kingdom | Company | <redacted> | Yes | We would request exemption for seals in highly demanding applications, such as the pharmaceutical and semi-conductor industries. | In the case of pharmaceutical and semi-conductor industries, there is currently no suitable alternative. | Part_1.docx | |||||||||||
26 | 3873 | BehalfOfAnOrganisation | 2023/04/05 11:56 | Request for exemption | Italy | Company | CAAST S.p.A. | In light of the fact that 90% of the materials we use are fluoropolymers or fluoroelastomers, many of which are qualified as compatible for food, pharmaceutical, and medical use, and there are currently no equally valid alternatives, we would like to understand if there is a possibility of excluding these substances (PTFE, FKM, FFKM, FEP) from the list of PFAS substances. Alternatively, we would like to understand if there is a possibility of being exempted from such restriction. Such restriction could lead to a total shutdown of our company. | Part_1.docx | |||||||||||||
27 | 3875 | BehalfOfAnOrganisation | 2023/04/06 15:07 | Request for exemption | Turkey | Company | PPG | we expect that the PFAS regulation shouldnt be affected to the Iundustrial Bakeware market because we haven't got an alternative product to replace our Fluoropolymer coatings in terms of release performance cycles yet. If it is must be bunned by ECHA or Reach it shouldnt be before 2030. we are waiting for your approval. | We are a job coater company for Industrial Bakeware market trays' and moulds etc. | Our Fluoropolymer cotaings sytems'release cycles min 3 times better than closest alternative coating system. | we need derogations for In | we need an derogation for Industrial bakeware. | ındustrial bakeware market, food ındustry. | Part_1.docx | ||||||||
28 | 3876 | BehalfOfAnOrganisation | 2023/04/07 11:52 | Request for exemption | United Kingdom | Company | <redacted> | Yes | THE INCLUSION OF POLYMERS PTFE,FEP,FFKM,FKM,FEPM IN THE ABOVE MENTIONED LEGISLATION IS UNECESSARY. THESE MATERIALS ARE USED IN SEALING PRODUCTS IN INDUSTRY WORLDWIDE WITH NO ALTERNATIVES. MANY CARRY APPROVALS FOR USE IN FOOD AND PHARMACEUTICAL APPLICATIONS WHICH ARE CLASSED AND APPROVED SAFE. AGRICULTURE,AEROSPACE,AUTOMOTIVE,FOOD, PHARMACEUTICAL,SEMI-CONDUCTOR,OIL FIELD AND MANY MORE, USE THESE MATERIALS. TO RESTRICT THEM WOULD HAVE A HUGE NEGATIVE IMPACT WORLDWIDE, FROM PRODUCER TO CONSUMER. | AGRICULTURE,AEROSPACE,AUTOMOTIVE,FOOD, PHARMACEUTICAL,SEMI-CONDUCTOR,OIL FIELD - ALL INDUSTRY! | BILLIONS IN WORLDWIDE TURNOVER,MILLIONS OF JOB LOSSES, UNIMAGINABLE CONSUMER IMPACT. SPECIFIC FIGURES TO OUR COMPANY ARE ATTACHED CONFIDENTIALLY . | Part_1.docx | ||||||||||
29 | 3877 | Individual | 2023/04/10 8:39 | Information on alternatives | | | If the European PFAS restriction on fluorine is proposed and production is discontinued, we will not be able to provide a stable supply to our customers, we would not be able to provide a stable supply to our customers because there is no alternative. We would like to avoid such a situation by all means, so we request that the above-mentioned restrictions be abolished. | Part_1.docx | ||||||||||||||
30 | 3878 | BehalfOfAnOrganisation | 2023/04/10 12:32 | Scope or restriction option analysis | Turkey | Company | <redacted> | Yes | The type of our coatings is Teflon, and the main reason we prefer Teflon application is its long post-coating life. We use Teflon in the production of industrial cakes because the pans are long-lasting and the risk of food contamination is much less than other coatings. In addition, last year, we carried out a project to reduce emission and pollution sources, and with this project, we switched from liquid Teflon to electrostatic powder Teflon. When using silicone or ceramic coatings industrially, the coating life is very short (for us, 1/4 of Teflon is less in some cases), which increases costs and labor. The trials in the coating processes we have done give an answer after 1 year at the earliest. Therefore, a ban that will take place within 2 years will greatly affect the preparation phase. We are in contact with our suppliers, but we want to make coatings without compromising our current process and quality. That's why our suppliers and we need more time. | Industrial cook bake Industrial pan coating | Our contaminated filter waste is halved. | The cost of teflon is much higher than that of silicon, and raw material and labor losses will increase at the same rate due to both the cost to come from here and the frequency of re-coating pans. | Part_1.docx | |||||||||
31 | 3879 | Individual | 2023/04/10 19:53 | | | | Please ban these products as quickly as possible and limit their emission into the environment to protect European public health and save future medical costs for member states. | Part_1.docx | ||||||||||||||
32 | 3880 | BehalfOfAnOrganisation | 2023/04/11 8:56 | Scope or restriction option analysis | Denmark | Company | <redacted> | Yes | Part_1.docx | |||||||||||||
33 | 3881 | BehalfOfAnOrganisation | 2023/04/11 12:33 | Information on benefits | Netherlands | Company | Fluortubing | SEMICON APPLICATIONS FLUORTUBING TUBES Fluortubing PTFE Tubings, known for its unique properties of chemical resistance, are widely used for delivering liquids in high-tech applications. These tubing are connected and installed to storage tanks that contain harsh chemicals such as hydrogen fluoride (HF) or hydrogen peroxide (H2O2). These chemicals are crucial for rinsing semiconductor processor chips used in computers and other semiconductor applications in order to purify their surfaces. Purification and achieving ultimate purity, along with chemical resistance, are paramount in adopting PTFE tubing for these high-tech applications. Without these specialized tubes, the economical and efficient production of microprocessors would be jeopardized, as computer chips cannot be produced without thorough cleaning with hydrogen fluorides and/or hydrogen peroxides. There are five objects that need to be purged from the semiconductor materials during the rinsing process: Particles Metal ions Organic matter Oil Oxide film None of these objects should be eluted or found before etching a microprocessor chip, as the purity of the chemicals and surfaces is crucial to ensure the quality of the final product. Due to its unique characteristics, PTFE is the ideal solution for maintaining the purity of the chemicals during the delivery process. PTFE tubing does not react with the chemicals and does not release any metal ions, making it the only suitable material for this application. The delivery hose must also be pure and stable, as it should not introduce contaminants or react with the chemicals being transported. In conclusion, Fluortubing PTFE tubing is essential for the safe and efficient delivery of harsh chemicals used in semiconductor manufacturing. Its unmatched properties of chemical resistance, purity, and non-reactivity make it the preferred material for ensuring the high-quality and purity of semiconductor materials during transportation and processing. | SEMICON | Fluoropolymer manufacturers are working on an incineration study and will submit information during the course of the public consultation period. Also Fluortubing is working on a recycling project. | 5 tons per year PTFE tubings produced for these semicon applications. | Without fluorotubing PTFE tubes for Semicon many jobs will disappear in h SEMICON industries | Part_1.docx | |||||||||
34 | 3882 | BehalfOfAnOrganisation | 2023/04/11 17:15 | | France | Industry or trade association | <redacted> | Yes | we use Per- and polyfluoroalkyl substances (PFAS) F for specific textiles and no solution to replace at the moment | all the product which use Per- and polyfluoroalkyl substances (PFAS) with our textile are for military (Airbus Helicopter TIGER AND NH90) and aeronautic, and some medical end products. there is no possibility to replace because of oil caracterisitics. | we use about 100 kg per year Per- and polyfluoroalkyl substances (PFAS) ; then we would like have a derogation for our products | we don't found any product today to be able technicaly substitutioned | Part_1.docx | |||||||||
35 | 3883 | BehalfOfAnOrganisation | 2023/04/11 17:52 | Scope or restriction option analysis | Norway | Company | <redacted> | Yes | to include also the fluoropolymers in the scope does not respect the principle of proportionality and the aim of this PFAS proposal. Further a limitation of fluoropolymers will increase risk and negative impact on the EU society related to safety for humans and environment ( ie not achieving transportation CO2 emission legislations and CO2 targets in case of alternative materials (if possible) and designs over the lifetime of a products / application. | Transportation: in your annex section A.3.11.1.3 "Combustion engine system" and the table under subsection "coatings and finishes" to the proposal you describe polymeric PFAS examples; you have to Add : coatings for fuel lines as well hydraulic brake hoses. Also in your table 8 of the proposal (section E.2.10) you only mention " seals, O-rings and gaskets), please ADD also " hoses and tubes" ( ie like for turbo, fuel , engine coolant , oil coolant, hydraulic brake), volumes for the latter contributes about 2 % - 5 % of the total volume you indicate in table A.10 ( tonnage per sector) | waste 4-6 % during the manufacturing of products (hoses and tubes) made out of fluoropolymers will be incinerate > 850 C (ie fully decomposed) | under point 6 O " vehicles" : based on our calculation of fluoropolymer content in tubes and hoses per vehicle in the transportation sector (passenger car, truck, bus) we estimate the usage at 300 tons globally per year . | Under point 6 O of table page 4 starting : design- and material changes in the automotive sector are expensive and difficult due to the extensive validation procedures to guarantee safety and performance of the vehicle; in our case of fluoropolymers hoses and tubes (PTFE, ETFE ) validation costs can range from Euro 50.000 to Euro 500.000 per case. As fluoropolymers are very expensive, they are the last solution to use because of their unique combination of properties, so only in cases there are no technical alternatives possibles OEM's designing in fluoropolymer materials, these also enables use of biofuels , downsizing of vehicles + engines and hybrids vehicles (due packaging of dual drivetrain). These are fundaments for the automotive industry to go to 100 % electrification , ie achieve existing and future CO2 emission legislations till 2035. Therefor a 12,5 year derogation is needed as 100 % electrical vehicles don't having combustion engines Under point 5 A of table starting page 4 : nowadays there are NON-fluoronated polymerization aids for PTFE available , therefor exclude form the scope respectively max derogation | Part_1.docx | ||||||||
36 | 3884 | BehalfOfAnOrganisation | 2023/04/12 9:52 | Scope or restriction option analysis | Switzerland | Company | <redacted> | Yes | Thank you. | Part_1.docx | ||||||||||||
37 | 3885 | BehalfOfAnOrganisation | 2023/04/12 11:03 | Scope or restriction option analysis | Belgium | Company | Datwyler Pharma Packaging Belgium NV | Products under discussion here are considered primary packaging, i.e. packaging of medicinal products with direct contact with the drug, therefore covered by the general exemption: "Fluoropolymers used in the pharmaceutical packaging sector are subject to requirements of the EU legislation on regulation of medicinal products for human or veterinary use (i.e., Regulation (EC) 726/2004 (EC, 2004), Directive 2001/83/EC (EC, 2001b), Directive 2001/82/EC) (EC, 2001a)." - This is also in line with EMA (European Medicines Agency). Therefore we believe it is incorrectly listed under sub-chapter: A.3.10.1.4 Coatings (page 79 of the Annex XV proposal) But should be listed under the Medicinal Products. ---------------------------------------------------------------------------------------- Importance of Fluoropolymer in our sector - end use application: The halobutyl substrate is a first prerequisite for medicinal rubber closures as they have the lowest permeability for air and moisture, and can be chemically seen be crosslinked in a clean way. The additional FP coating (via film deep drawing) or (via tumble spray coating) applied on top of the halobutyl functions as a barrier for the remaining chemical substances that can migrate from the rubber stopper (e.g. oligomers, anti-oxidants, plasticizers, cross linking residues,…). And the FP coating is inert on itself, to avoid additional adverse reactions with the drug medicine. The FP coated stoppers have proven their performance throughout the years: where expensive stability studies of new drugs at the big Pharma failed in combination with a standard halobutyl stopper, the FP coated version appeared successful. --------------------------------------------------------------------------------------- Till date, there is no alternative solution that fulfils the key attribute of showing ‘drug compatibility’. Uncoated halobutyl formulations have improved dramatically over the last decades, but do not reach the level of performance when using the FP coating. Alternative materials like PET film as coating, or replacing the complete halobutyl stopper with TPE have not been successful either. | Products under discussion here are considered primary packaging, i.e. packaging of medicinal products with direct contact with the drug, therefore covered by the general exemption: "Fluoropolymers used in the pharmaceutical packaging sector are subject to requirements of the EU legislation on regulation of medicinal products for human or veterinary use (i.e., Regulation (EC) 726/2004 (EC, 2004), Directive 2001/83/EC (EC, 2001b), Directive 2001/82/EC) (EC, 2001a)." This is also in line with EMA (European Medicines Agency). Therefore we believe it is incorrectly listed under sub-chapter: A.3.10.1.4 Coatings (page 79 of the proposal) But should be listed in the Medicinal Products. | All medicinal products have 100% traceble supply chain, strictly controlled, 100% is considered medical waste and at the end of life incenerated under controlled conditions and by dedicated companies. | Medicinal products (due to health and safety reasons) are not allowed to be recycled, but need to be incenerated, under controlled conditions and by dedicated companies. | 10-50 tons of fluoropolymer are used per year. | We supply 500 million pcs (which represents also 500 million drug injections), divided over more than 400 product codes for 186 pharmaceutical customers. Each single product was subject of a multi-year stability study by the pharmaceutical companies, including all different steps of clinical trials, after which filing and approval by the Health Authority was needed per country or in case of the US by FDA. Restarting such exercise is virtually impossible and will induce shortage of medicinal products on the market. The most likely scenario is closing down our European manufacturing site in Belgium, for which this FP coated portfolio is their key manufacturing part and transfer the production to our manufacturing sites in the US and in India. Such transfer also needs a re-qualification by the pharmaceutical manufacturer but is more moderate to execute. FP has a high INERTNESS towards drug medicines and acts as a BARRIER material for the Rubber stopper substrate. Below graph shows the barrier effect of a FP coating on the extractable/migrating chemicals from a rubber. The graph shows 2 spectra in mirror effect: above the 0-line the coated rubber, below the 0-line the same but uncoated rubber. Each peak represents an impurity or raw materials migrating out of the rubber. The height of the peak represents the amount migrating out of the rubber. It is clearly visible that the coating not only reduces the amount coming out of the rubber, but in many cases even completely eliminates the impurities coming out. For many drug formulations, certainly the more recently developed (e.g. mRNA vaccines like COVID, oncology, biological based drugs and cell-and-gene therapies), impurities coming from rubber may jeopardize the stability and effectivity of the drug itself and needs to be studied and controlled in ageing stability studies. In specific cases, the uncoated version fails such stability study and the coated rubber is the only option left. Secondly, each impurity needs to pass a safety and toxicological assessment. So, it is in the highest interest of a pharma company to select a rubber closure with the cleanest extractables profile, i.e. the coated version. | FP coating on closures, serves as INERT BARRIER coating for Extractables and Leachable from the rubber into the drug medicine. FP has a high INERTNESS towards drug medicines and acts as a BARRIER material for the Rubber stopper substrate. Below graph shows the barrier effect of a FP coating on the extractable/migrating chemicals from a rubber. The graph shows 2 spectra in mirror effect: above the 0-line the coated rubber, below the 0-line the same but uncoated rubber. Each peak represents an impurity or raw materials migrating out of the rubber. The height of the peak represents the amount migrating out of the rubber. It is clearly visible that the coating not only reduces the amount coming out of the rubber, but in many cases even completely eliminates the impurities coming out. Datwyler has invested for +10-years to develop a TPE (ThermoPlastic Elastomer) based stopper without success. Many other players trying to enter the market with TPE as well, yet, whereas TPE might replace some straightforward medicinal products, it will not replace the more sensitive medicinal products that require an FP coating. Datwyler recently finalized the development (~10 years development) of their ‘cleanest rubber formulation ever’, and albeit it has a very good Extractables and Leachable profile, it will not and cannot replace a FP coated variant. | Part_1.docx | |||||||
38 | 3886 | Individual | 2023/04/12 11:35 | Scope or restriction option analysis | | | Fluoropolymers are classified as non-hazardous. There are many technical processes in which these coatings are without alternative. A ban would lead to the outsourcing of production to third countries. | Part_1.docx | ||||||||||||||
39 | 3887 | BehalfOfAnOrganisation | 2023/04/12 19:19 | Scope or restriction option analysis | Ireland | Company | <redacted> | Yes | General comments: A complete list of uses and the relating functionalities would be too long to list. Fluoropolymers play an important role in virtually all industries. Within the sealing industry alone, the uses would run into hundreds of thousands of applications, each one reliant on the unique combinations of properties found with fluoropolymers (both fluoroelastomers and fluoroplastics such as PTFE): • Chemical resistance • Thermal resistance • Mechanical properties • Low permeability • Low leachable and extractable content • Low surface energy • Low flammability (cannot sustain a flame) • Low friction • High levels of cleanliness (impurities measured in parts-per-trillion in some cases) The strength of the carbon-fluorine bond and the polymeric structures of these polymers is unsurpassed. In the years since their developments in the 1950s, there has been no success in finding alternative materials which can serve to replace or improve on their performance – a period of almost 70 years. There are no technical alternatives available to fluoropolymers in all applications. This is not for the want of trying. It is also not related to cost/benefit drivers. For example, perfluoroelastomers (FFKMs) have a market price more than Eu1000/kg, with some varieties costing three times that. These polymers are used as a last resort where other products and/or designs cannot be used. With 70 years already passed since the commercialization of fluoropolymers, the chances of discovering and commercializing new alternatives within a timespan of proposed derogations (up to 13 years) is extremely unlikely if not impossible. The derogations are contradictory - they immediately ban the monomers but leave derogations for the polymers. So even though fluoropolymers could be used in areas covered by derogations, the restrictions on the monomers prevents the polymers being produced or imported. The list of sectors and sub-sectors considered is incomplete and lacks clear definition. Examples include: • Commodity items: o There is a large variety of commodity items such as sensors, valves, electrical systems which are used across various sectors. For example: an oxygen sensor may use PTFE as a sealing device (for chemical and thermal resistance, high purity, low outgassing etc) – this could be used for automotive applications, in the energy sector, in a pharmaceutical plant. How would these commodity items be treated? • Petroleum & mining industry - what is the definition of ‘petroleum industry’? Within the definition of ‘Petroleum’ the following is not clear: o Does this use cover the exploration, drilling, fracking, extraction and treatment (refining, cracking etc.) of oil, gas and related products? o Does this include Enhanced Oil Recovery using carbon dioxide? • Energy. The following sub-sectors do not appear to have been considered: o Carbon Capture, Utilization and Storage (CCUS). o Geothermal Energy o Hydrogen storage and hydrogen generation Health and Safety Executive (HSE), UK. HSE, the regulator for UK REACH, has worked with the Environment Agency to produce: “Analysis of the most appropriate regulatory management options (RMOA). Substance Name: Poly- and perfluoroalkyl substances (PFAS)”, dated March 2023. Of particular note is the differentiation between polymeric and non-polymeric PFAS, specifically: “In the most comprehensive British analysis of these chemicals ever, the Health and Safety Executive (HSE) has identified the most common and most harmful uses of PFAS and what measures could be put in place to control and manage them. The analysis considers existing laws and also how PFAS substances are being managed around the world, including Europe, Asia and the USA. For the PFAS substances considered in this RMOA, the available data do not indicate a clear association with any adverse health risks. However, the long-term effects of exposure to these persistent chemicals are not well understood, and toxicological data are limited. The underlying chemistry of PFAS (strong C-F bond) contributes to their persistent nature, which in turn leads to greater potential that they could cause serious and/or irreversible damage to the environment. PFAS families may be divided into two primary categories; non-polymeric and polymeric. Polymeric PFAS: Polymers have a somewhat special status in UK and EU REACH in that they are exempt from the registration requirements. Instead of registering polymers, the monomers and other reactants that comprise the polymer are registered in their place. However, polymer substances are not exempted from other parts of REACH. As such polymers – including polymeric PFAS – may be subject to restriction under REACH. The monomers that comprise the polymers may also be covered by the restriction provisions of REACH, if required… It is noted that because monomers used to create polymers are de facto intermediates, these monomers would be exempted from any authorisation provisions of REACH. Information submitted during the GB call for evidence suggests that fluoropolymers and fluoroelastomers are particularly important to the industrial, automotive, aerospace and defence sectors, where uses include membranes, diaphragms, gaskets, seals and pipe linings. The majority of industry responses to the GB call for evidence took the view that whilst alternative substances exist for some uses, the performance would be poorer and might require greater mass of the substitute. For fluoropolymers and fluoroelastomers, the industry view appears to be that for many or most uses there are no alternatives with the requisite performance characteristics. Petroleum and Mining: Tonnage in use Polymers 350-751 t/y; Estimated emissions 0.031 – 0.067 t/y Within this RMOA, risks from polymeric PFAS have been assessed in terms of the groups representing UK REACH registered PFAS monomers and processing aids. Potentially persistent polymer degradation products are considered within the relevant arrowhead groups. However, no attempt has been made to assess the likely levels of emissions of non-polymeric PFAS during service life and disposal of polymers. It is the case (more than likely) that PFAS are present in small quantities in semi-finished or finished imported goods (articles), but there is no requirement to register these imports unless the articles are designed to intentionally release the PFAS during service life and the aggregate import exceeds one tonne per year. Importers/suppliers may in any case be unaware of their presence, due to commercial confidentiality. The Agency concludes that it would be appropriate, considering the Precautionary Principle, to initiate some or all of the following risk management measures with regard to certain uses of PFAS: 2. UK REACH authorisation of PFAS used in processing aids in the manufacture and processing of fluorinated polymers The Agency has concluded that, based on the information gathered in this RMOA, a targeted restriction or a number of targeted restrictions would be a more effective regulatory option than authorisation for minimising releases of PFAS to the environment, including from polymers and imported articles and looking at substances of concern due to wide dispersive use, high emissions or indications from monitoring data. The preparation of any restriction dossiers would require substantial resource, in particular to refine emission estimates to ensure the targeting is appropriate, and data gathering for a socio-economic analysis, taking into account the availability and technical performance of alternative substances.” | Use and sub-uses: • Fluoropolymers used as packing elements, seals, gaskets, anti-extrusion devices. Sectors and sub-sectors: • Commodity items: o There is a large variety of commodity items such as sensors, valves, electrical systems which are used across various sectors. For example: an oxygen sensor may use PTFE as a sealing device (for chemical and thermal resistance, high purity, low outgassing etc) – this could be used for automotive applications, in the energy sector, in a pharmaceutical plant. How would these commodity items be treated? • Petroleum & mining industry - what is the definition of ‘petroleum industry’? Within the definition of ‘Petroleum’ the following is not clear: o Does this use cover the exploration, drilling, fracking, extraction and treatment (refining, cracking etc.) of oil, gas and related products? o Does this include Enhanced Oil Recovery using carbon dioxide? • Energy. The following sub-sectors do not appear to have been considered: o Carbon Capture, Utilization and Storage (CCUS). Uses and sub-uses: Low temperature and exposure to supercritical CO2 requires specialist sealing systems. Seal stacks utilizing PTFE are common due to permeation resistance, low temperature resistance, resistance to ‘dense’ (e.g. supercritical) CO2. o Geothermal Energy Uses and sub-uses: Whilst preparing wells for use in geothermal applications there are a variety of applications for both fluoroelastomers and fluoroplastics. The harsh nature of the application (potential for super-heated steam) means that other competing materials (e.g. EPDM) cannot offer comparable performance in a broad variety of sealing systems. o Hydrogen storage and hydrogen generation The adoption of hydrogen as an energy source depends on large-scale storage, which can be provided by geological formations (such as caverns, aquifers, and depleted oil and gas reservoirs) to handle demand and supply changes, a typical hysteresis of most renewable energy sources. Hydrogen Europe has published a substantial review of fluoropolymer usage in hydrogen applications in their “Position Paper on PFAS”, summarizing the uses and sub-uses. Health and Safety Executive (HSE), UK. HSE, the regulator for UK REACH, has worked with the Environment Agency to produce: “Analysis of the most appropriate regulatory management options (RMOA). Substance Name: Poly- and perfluoroalkyl substances (PFAS)”, dated March 2023. Of particular note is the differentiation between polymeric and non-polymeric PFAS, specifically: “In the most comprehensive British analysis of these chemicals ever, the Health and Safety Executive (HSE) has identified the most common and most harmful uses of PFAS and what measures could be put in place to control and manage them. The analysis considers existing laws and also how PFAS substances are being managed around the world, including Europe, Asia and the USA. Information submitted during the GB call for evidence suggests that fluoropolymers and fluoroelastomers are particularly important to the industrial, automotive, aerospace and defence sectors, where uses include membranes, diaphragms, gaskets, seals and pipe linings. The majority of industry responses to the GB call for evidence took the view that whilst alternative substances exist for some uses, the performance would be poorer and might require greater mass of the substitute. For fluoropolymers and fluoroelastomers, the industry view appears to be that for many or most uses there are no alternatives with the requisite performance characteristics. Petroleum and Mining: Tonnage in use Polymers 350-751 t/y; Estimated emissions 0.031 – 0.067 t/y Within this RMOA, risks from polymeric PFAS have been assessed in terms of the groups representing UK REACH registered PFAS monomers and processing aids. Potentially persistent polymer degradation products are considered within the relevant arrowhead groups. However, no attempt has been made to assess the likely levels of emissions of non-polymeric PFAS during service life and disposal of polymers.” | b) A complete list of uses and the relating functionalities would be too long to list. Fluoropolymers play an important role in virtually all industries. Within the sealing industry alone, the uses would run into hundreds of thousands of applications, each one reliant on the unique combinations of properties found with fluoropolymers (both fluoroelastomers and fluoroplastics such as PTFE): • Chemical resistance • Thermal resistance • Mechanical properties • Low permeability • Low leachable and extractable content • Low surface energy • Low friction • High levels of cleanliness (impurities measured in parts-per-trillion in some cases) c) Petroleum or energy sectors: There are estimates showing that there are over 3000 companies linked to the petroleum (oil and gas) market. This would not include suppliers to this market, for example companies producing seals, gaskets, sensors, valves etc. which could be used across a variety of industries, nor accompanying services such as accountants, marketing, consultants, advertising, legal etc. d) The strength of the carbon-fluorine bond and the polymeric structures of these polymers is unsurpassed. In the years since their developments in the 1950s, there has been no success in finding alternative materials which can serve to replace or improve on their performance – a period of almost 70 years. There are no technical alternatives available to fluoropolymers in all applications. This is not for the want of trying. It is also not related to cost/benefit drivers. For example, perfluoroelastomers (FFKMs) have a market price more than Eu1000/kg, with some varieties costing three times that. These polymers are used as a last resort where other products and/or designs cannot be used. • Hazards and risks: o Possible differences in functionality include: o Shorter service life o Increased risk of failure due to chemical and thermal degradation leading to potential catastrophic events (e.g., large chemical leaks) o Reduced service intervals and associated costs due to loss of production time o Increased servicing costs o Increase waste to landfill or incineration o Increased fugitive emissions o Increased risk of contamination of product (leachable and extractable contents of fluoropolymers are lower than competitive products) e) The early developments of PTFE (and similar polymers) can be found from 1938 though the synthesis of elastomeric polymers containing enough fluorine to impart a significant degree of stability was not achieved until the mid-1950's. Examples of technologies introduced since 1955 which have not been able to replace fluoropolymers: • Silicone polymers (VMQ) o These suffer badly from poor resistance to chemicals, offer poor permeation resistance and suffer from low mechanical properties o Poor in terms of outgassing • Fluorosilicone polymers (FVMQ) o Increased chemical resistance over VMQ polymers, but still offers inferior permeation resistance and low mechanical properties o Poor in terms of outgassing • Nitrile-butadiene rubber (NBR) o Lacks the high temperature and chemical resistance offered with fluoroelastomers o Low purity, poor outgassing • Hydrogenated nitrile-butadiene rubber (HNBR) o Lacks the high temperature and chemical resistance offered with fluoroelastomers o Low purity, poor outgassing • Polyacrylate rubbers (ACM and AEM) o Lacks the high temperature and chemical resistance offered with fluoroelastomers o Low purity, poor outgassing • Polyphosphazene rubbers o Lacks the high temperature and chemical resistance offered with fluoroelastomers • Polyaryletherketones (PAEKs) o The PAEK polymers offer advantages over PTFE in how the strength is maintained at elevated temperatures. However, the chemical resistance and friction properties are both inferior. • Polyimide polymers (PI) o Offer advantages over PTFE in how the strength is maintained at elevated temperatures. However, the chemical resistance and friction properties are both inferior. With 70 years already passed since the commercialization of fluoropolymers, the chances of discovering and commercializing new alternatives within a timespan of proposed derogations (up to 13 years) is extremely unlikely if not impossible. Information on possible differences in functionality and the consequences for downstream users and consumers (e.g. estimations of expected early replacement needs or expected additional energy consumption). Possible differences in functionality include: • Shorter service life • Increased risk of failure due to chemical and thermal degradation • Reduced service intervals and associated costs due to loss of production time • Increased servicing costs • Increase waste to land-fill or incineration • Increased fugitive emissions • Increased risk of contamination of product (leachable and extractable contents of fluoropolymers are lower than competitive products) g) In terms of socio-economic impacts, there are two main areas for consideration: • Environmental o The use of fluoroelastomer and poly(tetrafluoroethylene) offer advantages in the combination of thermal and chemical resistance over all other available materials. Their resistance to combinations of chemical and thermal attack reduces the likelihood of chemical leaks to the environment, including fugitive emissions. The social impacts of chemical leaks are obvious and fugitive emissions have been targeted by increasing legislation across a variety of industries. o Examples of fugitive emissions: According to the International Energy Agency, 20% of the world’s annual 570 million metric tons of methane emissions are fugitive. Under the United Nations Framework Convention on Climate Change, industrialised countries (“Annex I countries”) regularly report fugitive emissions. These inventories show stable emissions since the mid-2000s after a decline in the early 1990s and a rebound around 2000. In 2016, fugitive emissions reported by industrialised countries were 1.33 billion tonnes CO2 equivalent compared to 1.57 in 1990, about 85% of which were from the hydrocarbons sector, 15% from coal and a fraction from industry (UNFCCC GHG data) • Economic o Cost of fugitive emissions, example: EPA Source: EPA - Inventory of U.S. GHG Inventory of U.S. GHG Emissions and Sinks 1990 Emissions and Sinks 1990 -2004: $2billion of lost revenue o Reduced service intervals and associated costs due to loss of production time o Increased servicing costs | The derogations are contradictory - they immediately ban the monomers but leave derogations for the polymers. So even though fluoropolymers could be used in areas covered by derogations, the restrictions on the monomers prevents the polymers being produced or imported. The list of sectors and sub-sectors considered is incomplete and lacks clear definition. Examples include: • Commodity items: o There is a large variety of commodity items such as sensors, valves, electrical systems which are used across various sectors. For example: an oxygen sensor may use PTFE as a sealing device (for chemical and thermal resistance, high purity, low outgassing etc) – this could be used for automotive applications, in the energy sector, in a pharmaceutical plant. How would these commodity items be treated? • Petroleum & mining industry - what is the definition of ‘petroleum industry’? Within the definition of ‘Petroleum’ the following is not clear: o Does this use cover the exploration, drilling, fracking, extraction and treatment (refining, cracking etc.) of oil, gas and related products? o Does this include Enhanced Oil Recovery using carbon dioxide? • Energy. The following sub-sectors do not appear to have been considered: o Carbon Capture, Utilization and Storage (CCUS). o Geothermal Energy o Hydrogen storage and hydrogen generation The strength of the carbon-fluorine bond and the polymeric structures of these polymers is unsurpassed. In the years since their developments in the 1950s, there has been no success in finding alternative materials which can serve to replace or improve on their performance – a period of almost 70 years. This is not for the want of trying. Examples of technologies introduced since 1955 which have not been able to compete. With 70 years already passed since the commercialization of fluoropolymers, the chances of discovering and commercializing new alternatives within a timespan of proposed derogations (up to 13 years) is extremely unlikely if not impossible. In terms of socio-economic impacts and risks, there are three main areas for consideration: • Environmental o The use of fluoroelastomer and poly(tetrafluoroethylene) offer advantages in the combination of thermal and chemical resistance over all other available materials. Their resistance to combinations of chemical and thermal attack reduces the likelihood of chemical leaks to the environment, including fugitive emissions. The social impacts of chemical leaks are obvious and fugitive emissions have been targeted by increasing legislation across a variety of industries. • Economic o Cost of fugitive emissions o Reduced service intervals and associated costs due to loss of production time o Increased servicing costs • Hazards and risks: o Shorter service life o Increased risk of failure due to chemical and thermal degradation leading to potential catastrophic events (e.g., large chemical leaks) o Reduced service intervals and associated costs due to loss of production time o Increased servicing costs o Increase waste to landfill or incineration o Increased fugitive emissions o Increased risk of contamination of product (leachable and extractable contents of fluoropolymers are lower than competitive products) | Use and sub-uses: • Fluoropolymers used as packing elements, seals, gaskets, anti-extrusion devices. Sectors and sub-sectors: • Commodity items: o There is a large variety of commodity items such as sensors, valves, electrical systems which are used across various sectors. For example: an oxygen sensor may use PTFE as a sealing device (for chemical and thermal resistance, high purity, low outgassing etc) – this could be used for automotive applications, in the energy sector, in a pharmaceutical plant. How would these commodity items be treated? • Petroleum & mining industry - what is the definition of ‘petroleum industry’? Within the definition of ‘Petroleum’ the following is not clear: o Does this use cover the exploration, drilling, fracking, extraction and treatment (refining, cracking etc.) of oil, gas and related products? o Does this include Enhanced Oil Recovery using carbon dioxide? • Energy. The following sub-sectors do not appear to have been considered: o Carbon Capture, Utilization and Storage (CCUS). o Geothermal Energy o Hydrogen storage and hydrogen generation In terms of socio-economic impacts and risks, there are three main areas for consideration: • Environmental o The use of fluoroelastomer and poly(tetrafluoroethylene) offer advantages in the combination of thermal and chemical resistance over all other available materials. Their resistance to combinations of chemical and thermal attack reduces the likelihood of chemical leaks to the environment, including fugitive emissions. The social impacts of chemical leaks are obvious and fugitive emissions have been targeted by increasing legislation across a variety of industries. • Economic o Cost of fugitive emissions o Reduced service intervals and associated costs due to loss of production time o Increased servicing costs • Hazards and risks: o Shorter service life o Increased risk of failure due to chemical and thermal degradation leading to potential catastrophic events (e.g., large chemical leaks) o Reduced service intervals and associated costs due to loss of production time o Increased servicing costs o Increase waste to landfill or incineration o Increased fugitive emissions o Increased risk of contamination of product (leachable and extractable contents of fluoropolymers are lower than competitive products) | Part_1.docx | ||||||||
40 | 3888 | BehalfOfAnOrganisation | 2023/04/13 3:31 | Request for exemption | Japan | Company | 東興産業株式会社 | 当社ではフッソゴムを使用した電線を、耐熱性・耐火性の要求される環境下で使用されるユーザーに提供しています。半導体や自動車などの先端の製品の製造に於いて不可欠であり、今後も必要とするものです。使用の制限には反対致します。 | Part_1.docx | |||||||||||||
41 | 3889 | BehalfOfAnOrganisation | 2023/04/13 12:49 | Request for exemption | Spain | Industry or trade association | <redacted> | Yes | According to the current text/exceptions, a chemical substance use as API in medicines are exempt of pfas restictions but not their manufacturing intermediates/process. The current draft text could have several problems in the future if there is not changesin it. Europe would lose global relevance and competitiveness in the area of manufacturing active ingredients. Jobs could be lost and businesses closed. Some of these active ingredients have no therapeutic alternative (new drugs/apis) A change of manufacturing site has a regulatory impact for the health authorities, both for API manufacturers and for the pharmaceutical industry. This regulatory change takes a long time and may not be approved. The loss of total control over the manufacture of the Active Ingredients on site, may mean a loss of their quality (quality of raw materials, impurity profile, nitrosamines...) There may be a stock-out/shortage of medicines. In for that we would like to claim to include the MANUFACTURING PROCESS OF APIS IN EUROPE as exeption in the pfas restriction | According to the current text/exceptions, a chemical substance use as API in medicines are exempt of pfas restictions but not their manufacturing intermediates/process. The current draft text could have several problems in the future if there is not changesin it. Europe would lose global relevance and competitiveness in the area of manufacturing active ingredients. Jobs could be lost and businesses closed. Some of these active ingredients have no therapeutic alternative (new drugs/apis) A change of manufacturing site has a regulatory impact for the health authorities, both for API manufacturers and for the pharmaceutical industry. This regulatory change takes a long time and may not be approved. The loss of total control over the manufacture of the Active Ingredients on site, may mean a loss of their quality (quality of raw materials, impurity profile, nitrosamines...) There may be a stock-out/shortage of medicines. In for that we would like to claim to include the MANUFACTURING PROCESS OF APIS IN EUROPE as exeption in the pfas restriction | According to the current text/exceptions, a chemical substance use as API in medicines are exempt of pfas restictions but not their manufacturing intermediates/process. The current draft text could have several problems in the future if there is not changesin it. Europe would lose global relevance and competitiveness in the area of manufacturing active ingredients. Jobs could be lost and businesses closed. Some of these active ingredients have no therapeutic alternative (new drugs/apis) A change of manufacturing site has a regulatory impact for the health authorities, both for API manufacturers and for the pharmaceutical industry. This regulatory change takes a long time and may not be approved. The loss of total control over the manufacture of the Active Ingredients on site, may mean a loss of their quality (quality of raw materials, impurity profile, nitrosamines...) There may be a stock-out/shortage of medicines. In for that we would like to claim to include the MANUFACTURING PROCESS OF APIS IN EUROPE as exeption in the pfas restriction | Part_1.docx | ||||||||||
42 | 3890 | Individual | 2023/04/13 13:24 | Information on alternatives | | | Referring to PFA, PTFE ... Polymers, they represent very selective combined Corrosion and temperature resistance and in many chemical production processes and also very environment and alternative energy relevant processes ther is no alternative for Fluor containing polymers!! | Production of Sulphuric acid by WSA (wet) process, production of Epichlorhydrin for Epoxid-resins ( main material for wind mill rotors), Productions producing and using Hydrochloric acid and other halogenic acids | Vessels in the chemical industry are dismatled and recycled at the end of life and it is also applied for PFA-Liners in vessels. | There are no emissions from Fluorinated Plastics because they are very resistant. | in WSA Sulphuric acid process substitution is only possible by lead, but energy efficience of the process in much lower. For applications with Hydrochloric acid and other acids in chemical processes the use of enemel and graphite is an alternative, but only very small equipment can be produced and therefore the production processes become uneconomical. | Lead is not HSSE kindly , Energy consumption in the production processes for alternatives are causing higher CO2 emissions. | Part_1.docx | |||||||||
43 | 3891 | BehalfOfAnOrganisation | 2023/04/14 10:54 | Scope or restriction option analysis | Switzerland | Company | Datwyler | Fluoropolymers are widely used in many different sectors due to the unique properties they give: • Strong resistance - to low (-40°C) and high (+250°C) temperatures; • Aggressive fluids and fuels resistance; • High resistance to permeability; • Increased lifetime and reliability of components (increasing the safety and also sustainability); • Great compression set at low and high temperatures We provide Fluoropolymer based articles (FKM, PVDF, PTFE, PTFE as surface coating) for these sectors: - Construction materials and products - Petroleum (oil & gas) & mining - Electronics and semiconductors - Energy applications, including batteries and hydrogen - Transportation (Automotive) - Aerospace - Industrial applications (chemical industry) - Water and wastewater treatment Currently there are no alternatives to Fluoropolymers. A replacement is only possible with significant compromises in functionality. In multiple cases functionality of the systems will not be given anymore with alternatives. Other materials can offer similar properties (not the same), but only for one of the multiple characteristics of FP (above mentioned). | We produce rubber articles made with Fluoropolymers (FKM, PVDF, PTFE, PTFE as surface coating) for these sectors: - Construction materials and products - Petroleum (oil & gas) & mining - Electronics and semiconductors - Energy applications, including batteries and hydrogen - Transportation (Automotive) - Aerospace - Industrial applications (chemical industry) - Water and wastewater treatment | Fluoropolymers should not be treated as monomeric PFAS. There are no emissions of momeric PFAS into the environment at the end of life of items made with fluoropolymers. For the automotive sector there are IMDS and ELV directives. Both regulate the separation of waste and the end-of-life treatment of such products. We don't have more information on the other sectors. | - Construction materials and products - 14 Million Pcs. / Year - Petroleum (oil & gas) & mining - 2.5 Million Pcs / Year - Electronics and semiconductors - 4.5 Million Pcs. / Year - Energy applications, including batteries and hydrogen - 6 Million Pcs. / Year - Transportation (Automotive) - 35 Million Pcs. / Year - Aerospace - 3.5 Million Pcs. / Year - Industrial applications (chemical industry) - 40 Million Pcs. / Year - Water and wastewater treatment - 120 Million Pcs. / Year | By providing durable and effective protection against heat, aggressive fluids and fuels, humidity, vibrations and compressions, they prolong the useful life of various components critical for performance, emission control, and safety to the automotive industry. Replacements of FPs is only possible with significant compromises in functionality. In multiple cases functionality of the systems will not be given anymore with alternatives. Other materials can offer similar properties (not the same), but only for one of the multiple characteristics of FP. E.g. HNBR / ACM / AEM rubber can offer resistance to aggressive fluids (not as high as FKM), but at the same time, it doesn’t have the same level of Heat Resistance as would have FKM. For these reason each application must be re-evaluated. It will take several years, involving engineering, R&D, production tests, validations. This variety of properties makes FPs unique as they can cover a wide range of applications compared to other materials in the rubber industry. At the moment, a full substitution of FP-based materials is unlikely. If we stop producing articles with FP-based materials, there will be a significant direct loss of the revenue (20%), with consequence of reorganization (lay-off up to 20% of workers). The indirect loss might be higher as the specific industry (e.g. automotive) comes to a standstill. That may result in a complete stop of turnover, also for non-fluoropolymer related components. | In the Automotive sector, there are currently no valid alternatives to Fluoropolymer-based products. A ban of Fluoropolymers, will result in a no possibility to use transport vehicles with ICE, not only for new ones but also for existing (spare parts no longer available). This involve: Cars, trucks, tractor, motorbikes, ships, planes, and so on… Since FPs are also essential for developments for battery applications, also hybrid cars and EVs are impacted. All industrial applications would be affected with a reduction of availability and/or increase of cost for consumers in EEA. Additionally, their high resistance to permeability makes them excellent for applications in contact with hydrogen. | Our FP-based articles are in contact with aggressive fluids (e.g. oils, fuels, greases) and they have strong resistance to low (-40°C) and high (+250°C) temperatures. - Construction materials and products - Petroleum (oil & gas) & mining - Electronics and semiconductors - Energy applications, including batteries and hydrogen - Transportation (Automotive) - Aerospace - Industrial applications (chemical industry) - Water and wastewater treatment Fluoropolymers are widely used due to the unique properties: • Strong resistance - to low (-40°C) and high (+250°C) temperatures; • Aggressive fluids and fuels resistance; • High resistance to permeability; • Increased lifetime and reliability of components (increasing the safety and also sustainability); • Great compression set at low and high temperatures Few uses not identified in the proposal: - FKM O-Rings that are used in the transmission of wind turbines. - FKM O-Rings that are used to seal moulds in the production of Health Care Products. - FKM based seals in H2 Electrolysers. - FKM based developments for battery and fuel cell applications. - Sealing applications in valves for contact with gases (methane and 100% hydrogen -- EU 2030 green hydrogen goal). - FKM O-Rings and other FKM seals are generally preferred by our customers due to their increased durability, compared to other materials (increasing sustainability). | Part_1.docx | |||||||
44 | 3892 | BehalfOfAnOrganisation | 2023/04/14 10:58 | | China | Company | <redacted> | Yes | Fluorochemical is not alternative to many areas, please consider a derogation for fluoropolymers and refrigerant gas. | Part_1.docx | ||||||||||||
45 | 3893 | BehalfOfAnOrganisation | 2023/04/14 13:11 | Scope or restriction option analysis | Japan | Company | <redacted> | Yes | The "PCB pattern direct drawing device" uses PFAS as the contact member that attracts and fixes the printed circuit board to be printed. The reason for this is the purpose of stripping from the contact member without destroying the adhesive resist applied to the printed circuit board. The use of PFAS is mandatory and cannot be substituted. Therefore, please exempt from "PCB pattern direct drawing equipment". | "5. By way of derogation, paragraphs 1 and 2 shall not apply to:" | Part_1.docx | |||||||||||
46 | 3894 | BehalfOfAnOrganisation | 2023/04/14 16:08 | Scope or restriction option analysis | Germany | Company | Boss Lubricants GmbH & Co. KG | PFPE and PTFE are used in medical device lubrication. These lubricants are not metabolized and show no toxicity according to our tests (see confidential data). The products are extremly expensive (up to several thousand €/kg) and therefore are only used, where necessary in the lowest necessary amount. Therefore the potential emission is also extremely low. So, all in all we have non-toxic products, that do not reach the environment in considerably amounts. A restriction is therefore not justifiable. In our opinion, due to the huge socio-economic impact of a restriction of PFPE and PTFE on the medical care (hospitals and doctors could not work any more, like before; see below), together with the low toxicity risk, an exemption should be considered: - total exemption without any transition period for PTFE and PFPE used in all sectors or - total exemption without any transition period for PTFE and PFPE used in medical sectors Additionally, we plead to derogate the use of the monomers for the above mentioned polymers in the production of PFPE and PTFE. If only the above mentioned polymers are exempted in the EU, the products have to be produced in other countries which leads to a marked disatvantage for the EU. And in other countries the awareness for the environment might be not that high, as it is in the EU. In the end this could lead to higher pollution of the world as a whole. | Sectors: Medical devices and Lubricants PFPE and PTFE are important components in lubricants for medical industry. They are not metabolized and have one of the best toxicity-profiles (see confidental data for information on cytotoxicity, hemocompatibility, systemic toxicity, pyrogenity). | Estimated emission share for maufacturing phase: <0,01% (products are quite expensive and therefore carfully prepared to minimize wasting). In production of 100 kg PFPE/PTFE-grease about 50-100 g stick on the maschines (vessels, roll mills etc.). These 100 g are carefully cleaned up and disposed to incineration, so usually there should not be an emission to the environment at all. Estimated emission share for use phase: <0,01% (the PFPE/PTFE-based lubricants in medical devices are made as a lifetime lubricant, so emission is only due to loss on leakages. Leakages are rare, as the medical devices are usaually sealed). Estimated emission share for end of life phase: <0,1% PFPE and PTFE based lubricants that are used in medical applications (implants, medical devices) are disposed together with the parent device. As these typically are either potentially infectious (e.g. removed implants) they are incinerated. As the incinerators have HF-filters, total emissions are supposed to be low. Non-infectious devices are usually diposed together with electronic or general hazardous waste. As these are also incinerated or molten, where the PFAS decompose, here also total emissions are supposed to be low. | Taking into account our market share (in our oppinion we are one of the three main producer for special PFPE/PTFE lubricants in medical applications) for PFPE/PTFE lubricants in medical applications, we estimate the amount of these PFAS as a lubricant in medical devices to be 1-10 tons/year. Estimated emission to the environment: <0,1% | We suppose, that for PFPE/PTFE based lubricants for medical applications the derogation 5s is suitable, as without these lubricants no safe use would be possible. As product development time for medical devices can be quite long, even 13.5 years could be a quite short transition time. Please check for the comments of medical device manufacturers. | PFPE/PTFE-based lubricants for medical applications might fall in a first instance under "lubricants not used under harsh conditions", as temperature and atmospheric conditions are not harsh. However, the requirements for those lubricants are extremely high: a) long time stable for life-time lubrication (especially in implants) b) non-soluble in water or in body liquids c) not mobile in the body d) non metabolizable in humans and animals e) non-cytotoxic f) hemocompatible g) non-pyrogenic h) not systemic toxic i) do not form decomposition products during application j) do not contain unwanted impurities from raw material production product maufacturing k) can be sterilized for re-use in hospitals and at doctors All these requirements can only be fulfilled with PFPE/PTFE based lubricants. There is no other chemical composition known, that fulfill all the requirements at once. Therefore, without PFPE/PTFE-based lubricants no surgery with the help of electro-mechanical devices (power tools, saws, drills,... surgery robots, ecmo-systems,...) would be possible any more and also mechanically active implants (pumps, screw drives,..) would not be available in the known situation. | Part_1.docx | ||||||||
47 | 3895 | BehalfOfAnOrganisation | 2023/04/14 17:26 | Scope or restriction option analysis | Germany | Company | Richter Chemie-Technik | The contribution is listed in the appropriate section | Any fluoropolymers sectors and sub-uses | Nearly 100% of the fluoropolymer processed is incinerated at the end of its useful life. Chemical plant operators dispose of chemically contaminated pumps and valves by incineration. The annual fluoropolymer quantities can be found in the Appendix | Dry and clean mechanical PFA chips (5to p.a.) are processed for cable sheathing (PFA). Wet chips are disposed of via the waste disposal company (1to p.a.) | 100to p.a. PFA are proceed for pumps and valves. The Fluorpolmere are conform to the latest REACH PFAS restrictions. The PFAS limits are confirmed by the manufacture as well as an external labratory. The PFAS values are smaler in the final product than in the resin after processing. | Detail data are in the Excel Spread Sheet form the downstream User Questionnaire_SEIA data collection_20230210 | Detail data are in the Excel Spread Sheet form the downstream User Questionnaire_SEIA data collection_20230210 | Detail data are in the Excel Spread Sheet form the downstream User Questionnaire_SEIA data collection_20230210 | There is no practical measuring equipment to robustly measure the current REACH restricted PFAS emissions (ppb) in production areas such as ovens and ventilation systems. There are no global standards for measuring REACH-restricted PFAS in primary and finished materials such as PFA granules and PFA liners. | Part_1.docx | https://www.industrydocuments.ucsf.edu/chemical/docs/#id=jxhv0346 | ||||
48 | 3896 | BehalfOfAnOrganisation | 2023/04/17 10:26 | Scope or restriction option analysis | Sweden | Company | Envirotainer AB | Envirotainer General Comment: We suggest a separate 13.5-year derogation for actively refrigerated containers for pharmaceutical air freight (ULDs). This solution, according to an ongoing analysis that we will provide at a later date, is the only way to ensure enough development time. We suggest a derogation for: “Refrigerants in active temperature-controlled containers certified for air freight by European Union Aviation Safety Agency (EASA) until 13.5 years after EIF;” Alternatively, clarifying the definition of "Transport Refrigeration" to include active ULDs would help in securing some time under the transport derogation. However, we believe this would give insufficient time to develop a PFAS-free alternative due to the aviation safety constraints governed by EASA. Active refrigerated ULDs (Unit Load Devices) are mainly used for medicine transport (vaccines, biopharmaceuticals) in air freight and are an essential aspect that Annex XV has not addressed. These ULDs, with active refrigeration systems, are rigorously regulated by aviation authorities such as EASA/FAA, adhering to stringent safety, weight, and dimension requirements. The significance of active refrigerated ULDs cannot be overstated, particularly for the transportation of sensitive pharmaceuticals. Recognizing the importance of PFAS restrictions for public health, it is still crucial to establish a transitional period to ensure the uninterrupted operation of the active pharmaceutical cold chain. Due to the combination of Annex XV and F-Gas Procedure 2022/0099/COD, the only remaining alternative refrigerants for ULDs are natural refrigerants. Due to stringent safety standards, it will take up to 12 years to develop a safe solution for air freight using flammable options. For non-flammable options there has been a lack of component development to the size, efficiency, and weight constraints of ULDs. Please see the attached main submission letter for details as well as contact information for additional data. | Envirotainer Comment: Our comment concerns a specific sub-use not explicitly stated in Table 9 of Annex XV. However, we believe that this sub-use has enough commonality between some sub-uses stated in Table 9 to fall under the same definition, if allowed for some amendments. Sectors: Applications of Fluorinated Gases, Transport Relevant sub-uses: Refrigeration, Transport Refrigeration, Mobile Air Conditioning The analysis of Annex XV states that the above sub-uses have no technically or economically feasible alternatives at EIF. These sub-uses receive derogations of between 5 and 12 years. Actively refrigerated Unit Load Devices (ULDs), face higher challenges than the above sub-uses. Due to stringent safety, weight, and dimension regulation from European Union Aviation Safety Agency (EASA) more time is required to develop solutions. There is currently low substitution potential for refrigerants due to: Safety concerns using flammable natural refrigerants require a derogation period to develop safety and redundancy systems in case of damage or leakage on-board a plane. Also, additional time is needed for the extensive validation process from EASA, forwarders, and airlines. Component availability/development is not yet mature for non-flammable refrigerants such as CO2. A derogation period would ensure enough time to develop systems using these safe natural refrigerants. We request the use of active refrigerated ULDs be given a derogation period due to similar reasons to the sub-uses mentioned above. A specific derogation for this field is the best option to ensure and un-interrupted cold chain. | Envirotainer Comment: See attached “Question 2 - Emissions in the end-of-life phase (Confidential)” pdf file. | Envirotainer Comment: See attached “Question 6 - R&D Processes (Confidential)” pdf file. | Envirotainer Comment: The market for temperature-controlled airfreight solutions used for transporting pharmaceuticals consists of passive and active solutions. Active solutions (using a compressor driven temperature control system) constitute a tangible (ca 20%) and growing share (Active growing at +15% CAGR vs. ca +7% CAGR for passive) of the market. During recent years, the pharma industry has transitioned from chemical treatments to biological, so-called large molecule, treatments. The growth of the market is driven by the underlying growth of these biological pharmaceutical treatments, which are used e.g., for oncology, diabetes treatments, vaccines etc.), but also novel modalities, cell & gene, and during the pandemic mRNA treatments. The need for international air transportation of pharmaceuticals is driven by the extreme temperature sensitivity and high value of these shipments, where air transportation is paramount, as the only alternative - sea shipments – is in most cases is not an option due to the time required (months) and the risks of experiencing temperature excursions (making the treatments ineffective or dangerous during such a long shipment. Also, the complexity of demand planning for the supply chain of these treatments results in the need for just in time deliveries from single manufacturing sites to global markets, which again requires air transportation in order for patients to reach their life critical treatments in time. Active solutions in particular are specifically designed for airfreight and in addition to complying with strict pharmaceutical industry regulations, also complying with air safety regulations. Their specific design enables more cost-effective shipments (resulting in lower cost of treatment for the patient), and more sustainable shipments (CO2 emission savings of up to 90% vs. passive solutions). Envirotainer’s market share is ca 10% of the total market. In 2022, Envirotainer supported shipments of ~750 million doses of life critical pharmaceuticals. In addition, Envirotainer played a key role in the global distribution of covid vaccines and treatments, supporting shipments of well over 1 billion doses of covid vaccines. We will strive to input more data and analysis into the consultation in future comments. | Part_1.docx | https://www.industrydocuments.ucsf.edu/chemical/docs/#id=kxhv0346 | ||||||||
49 | 3897 | BehalfOfAnOrganisation | 2023/04/17 12:26 | Hazard or exposure | Netherlands | Company | Hardick B.V. | We produce PTFE coated high temperture resistant conveyor belts and related products. We have been doing that for over 40 years. We have undertaken many risk assessments in that time, by both internal workers and external parties. No specific risks on our use of PTFE did ever came out, nor did we ever had a stakeholder that lost its health due to our processes or products. Because of the demands of our conveyor belts being high temperature resistance and non stick there is no general, well functioning alternative. Our belts are very expensive, an alternative would hence have a good opportunity in our markett but has so far not been found. We supply our belts and products to about 1000 annual customers (from small businesses to multinationals) all over the world. 70% of our sales is exported, more than half of that export goes to other EU companies. If PTFE and PFA remain on the banned PFAS list, we have no alternative than to close our company and letting go over 50 employees. At many of our customers the same will happen as there are not many alternatives for our belts. PTFE (and PFA) as a fluoropolymer has different properties than the general PFAS-substance. PTFE (and PFA) is not hazardous in use or in waste streams. With banning PTFE (and PFA) the EU will give a major advance to the USA, India and China (and basically rest of the world) in production and distribution of necessary tools, products and machines for every day life usage and for innovations. | We produce PTFE coated conveyor belts, tapes and sheets. Apart from sector Industrial food and feed production this application is not mentioned in Table 9. More information is given in the attachement. | We are a small company (40 FTE), but relatively large in our market of PTFE conveyor belts, tapes and sheets. a: Our annual usage is about 40 tons of PTFE in our closed PTFE coated materials and about 20 tons of PTFE in our mesh materials. On top of that about 5 tons of PFA in our films. b: PTFE and PFA secure high temperature resistance, non-stick, low friction, stability of the fabrics c: In NL minimum 3 other companies as ours, in Germany 10. Probsbly more than hundred in the whole EU. Customers using our sectors' products without alternatives count up to thousands. d: Even after over 10 years of working on alternatives we have not found or developped a working alternative e: Working together with producers in other sectors that make products that could work for our belts. Also working in our R&D dept together with customers. Time never kept, but multiple employees over many years. f: Unknown. g: Unknown. Our company has over 50 employees and over 7M EU sales | Listed in my attachement | Part_1.docx | https://www.industrydocuments.ucsf.edu/chemical/docs/#id=rjhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=qjhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=pjhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=yjhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=mjhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=njhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=ljhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=kjhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=jjhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=xjhv0346 | |||||||||
50 | 3898 | BehalfOfAnOrganisation | 2023/04/17 16:25 | | Switzerland | Company | <redacted> | Yes | See confidential attachment | See confidential attachment | Part_1.docx | |||||||||||
51 | 3899 | BehalfOfAnOrganisation | 2023/04/17 18:47 | Hazard or exposure | Italy | Company | <redacted> | Yes | Dear Sirs, we are a Company that produce PTFE compounds, micropowders for additivities and post-treat PTFE suspension. We comment the Annex XV because we support the fact that PTFE cannot be considered and regulated in the same way than the short chain PFAS, because it is not dangerous and cannot be replaced in majority of the actual applications. The peculiar properties of chemical inertia, thermal resistance and friction, are for PTFE both the advantage and the problem because it is no toxic or dangerous for health , resistant to hard environment and working conditions, but at the same time it is persistent in the environment. We support the fact that a good end of life management of the polymer is the most efficient compromise to take advantage from the opportunities of use of this particular PFAS. We have no direct contact with final manufacturers, so we have no access to data referred to the single application. Our contribute can be evidence in socio economic impact that the PTFE ban could have in our area. Our company is specialized in PTFE compounding, PTFE micropowder and industrial PTFE turnings recycle (Reprocessed Material), we collect those from our customers and after treatment it is possible to reuse for some applications. There is no possibility to convert the whole machinery used in POLIS for the PTFE treatment in different processes, so the only chance in case of PTFE ban, is to close the activity. The social economic impact will involve: Product Volume sold (2022) Volume loss (total ban of PTFE) PTFE 1000-2000 t/y 100% loss PTFE compound 2000-3000 t/y 100% loss PTFE micropowder 500-1000 t/y 100% loss PTFE reprocessed (by industrial turnings) 500-1000 t/y 100% loss Number of workers involved (people) : 160 Number of redundancy (total ban of PTFE) :160 Polis market share will be completely absorbed by non EEA companies that will produce in non EEA country. | Food contact material and packaging, Cosmetic, Medical device, Transport, Electronics and semiconductor, Energy sector, Lubricant, Petroleum and mining are all fields where PTFE post-treated by Polis is used. Other involved sectors are CPI, Pharmaceutical , Industrial gaskets and bearing. | Part_1.docx | |||||||||||
52 | 3900 | BehalfOfAnOrganisation | 2023/04/18 7:58 | Hazard or exposure | Germany | Company | <redacted> | Yes | Used material PFA Type 6505TZ (Dyneon), Type 6515 TZ (Dyneon), Type 6502TZ (Dyneon), Type 8003 (INOFLON), Type 8015 (INOFLON), Type 8003 HS (INOFLON), Type 8015HS (INOFLON) CLP Regulation No. 1272/2008 Not classified as a hazardous substance CAS-number: 26655-00-5 No hazard or exposure due to the material PFA No environmental emissions due to the material PFA: No equivalent alternatives for the pump material type PFA in the applications: pharmaceutical precursors, green hydrogen production, food precursors, pumping of dangerous acids, alkalis and chemical wastewater. Pumps in these applications must be chemically sterilizable and have to have a high resistance to the sterilization agents. Highly fluorinated sealing materials: There are alternatives for the sealing materials FPM, FFPM and TFM to avoid dangerous exposure of the pumped media. These materials are required because of their high resistance to critical and dangerous media. Socio-economic impacts: If these materials are banned, the consequences are as follows: health and environmental hazards. Significant technological step backwards in the manufacture of the aforementioned products. Socio-economic impacts: If these materials are banned, the consequences are as follows: health and environmental hazards. Significant technological step backwards in the manufacture of the aforementioned products. Reduction of quality of life due to technological limitations in the aforementioned areas. Reduction of electromobility. Increased dependency on a few Asian trading partners in the semiconductor industry. No listing in Annex XV of the REACH regulation Request for exemption: We apply for the exclusion of the substances mentioned (Fluoropolymers and highly fluorinated sealing materials) from the PFAS ban. | Part_1.docx | ||||||||||||
53 | 3901 | BehalfOfAnOrganisation | 2023/04/18 8:03 | Hazard or exposure | Germany | Company | <redacted> | Yes | Used material PVDF: Type Polytetraflon® PTFE No risk or exposure due to the material PTFE No environmental emissions due to the material PTFE No equivalent alternatives for the pump material PTFE in the application of chlorine electrolysis. EC number PVDF: CLP Regulation No. 1272/2008 Not classified as a hazardous substance CAS-number 24937-79-9 Highly fluorinated sealing materials: There are alternatives for the sealing materials FPM, FFPM and TFM to avoid dangerous exposure of the pumped media. These materials are required because of their high resistance to critical and dangerous media. Socio-economic impacts: If these materials are banned, the consequences are as follows: health and environmental hazards. Significant technological step backwards in the manufacture of the aforementioned products. Reduction of quality of life due to technological limitations in the aforementioned areas. Reduction of electromobility. Increased dependency on a few Asian trading partners in the semiconductor industry. No listing in Annex XV of the REACH regulation Request for exemption: We apply for the exclusion of the substances mentioned (Fluoropolymers and highly fluorinated sealing materials) from the PFAS ban. | Part_1.docx | ||||||||||||
54 | 3902 | BehalfOfAnOrganisation | 2023/04/18 8:08 | Hazard or exposure | Germany | Company | <redacted> | Yes | Used material PVDF: Type Solef 6012 (Solvay), Type Solef 1008 (Solvay) No hazard or exposure due to the material PVDF No environmental emissions due to the material PVDF No alternatives for the pump material PVDF in the applications: pharmaceutical precursors, food precursors, pumping of dangerous acids, alkalis and chemical waste water, battery recycling, fertilizer production . Chlorine electrolysis. Pumping of ultrapure water for semiconductor and microchip production. EC number PVDF: CLP Regulation No. 1272/2008 Not classified as a hazardous substance CAS-number 24937-79-9 Highly fluorinated sealing materials: There are alternatives for the sealing materials FPM, FFPM and TFM to avoid dangerous exposure of the pumped media. These materials are required because of their high resistance to critical and dangerous media. Socio-economic impacts: If these materials are banned, the consequences are as follows: health and environmental hazards. Significant technological step backwards in the manufacture of the aforementioned products. Reduction of quality of life due to technological limitations in the aforementioned areas. Reduction of electromobility. Increased dependency on a few Asian trading partners in the semiconductor industry. No listing in Annex XV of the REACH regulation Request for exemption: We apply for the exclusion of the substances mentioned (Fluoropolymers and highly fluorinated sealing materials) from the PFAS ban. | Part_1.docx | ||||||||||||
55 | 3903 | BehalfOfAnOrganisation | 2023/04/18 8:11 | Hazard or exposure | Germany | Company | <redacted> | Yes | Used material PTFE: PTFE: Type Polytetraflon® PTFE No risk or exposure due to the material PTFE No environmental emissions due to the material PTFE No equivalent alternatives for the pump material PTFE in the application of chlorine electrolysis. EC number PTFE: CLP Regulation No. 1272/2008 Not classified as a hazardous substance CAS-number: 9002-84-0 Highly fluorinated sealing materials: There are alternatives for the sealing materials FPM, FFPM and TFM to avoid dangerous exposure of the pumped media. These materials are required because of their high resistance to critical and dangerous media. Socio-economic impacts: If these materials are banned, the consequences are as follows: health and environmental hazards. Significant technological step backwards in the manufacture of the aforementioned products. Reduction of quality of life due to technological limitations in the aforementioned areas. Reduction of electromobility. Increased dependency on a few Asian trading partners in the semiconductor industry. No listing in Annex XV of the REACH regulation Request for exemption: We apply for the exclusion of the substances mentioned (Fluoropolymers and highly fluorinated sealing materials) from the PFAS ban. | Part_1.docx | ||||||||||||
56 | 3904 | BehalfOfAnOrganisation | 2023/04/18 8:26 | Scope or restriction option analysis | Germany | Company | <redacted> | Yes | Wir benötigen zur statischen als auch dynamischen Abdichtung in Gleitringdichtungen O-Ringe. | Part_1.docx | ||||||||||||
57 | 3905 | Individual | 2023/04/18 11:14 | Environmental emissions | | | OK | Part_1.docx | ||||||||||||||
58 | 3906 | BehalfOfAnOrganisation | 2023/04/18 11:27 | Hazard or exposure | Germany | Company | Ahauser Gummiwalzen Lammers GmbH & Co. KG | As a manufacturer of rubberised roller covers with an additional PFA or FEP coating in the form of an extruded semi-finished product as a functional layer Down Stream User), we primarily supply companies in the liquid packaging industry. The covers we produce are directly and immediately required for the production of food packaging materials and cannot be substituted. When used as intended, no hazards are to be assumed. FEP and PFA and ETFE are known as "polymers of low concern"( PLC) as defined by the OECD. They are not high risk materials as they are not water soluble, not bioavailable or bioaccumulative, inert, stable and non-toxic and do not contain harmful PFAS materials. Furthermore, due to their inertness, our coatings are specifically used in the medical care sector and are not substitutable. | a: No data b: Unknown, since semi-finished product c: 136 d: No alternatives because of the required combination of chemical inertness, dehesive behaviour, chemical resistance, e: In the field of aseptic liquid packaging production due to the wetting and polar displacement of the acid co-polymers to be coated by adhesion promoting measures which are indispensable (corona, ozone, flame treatment), no substitute has been found in the entire rubber coating industry for about 25 years. f: no information g: loss of 30% of jobs in our company. The damage to consumers caused by the loss of almost all liquid packaging systems cannot be quantified if PFA, FEP and ETFE are banned. For the global manufacturers of liquid packaging, a ban means a complete inability to act due to a lack of alternatives to PFA/FEP coated rollers or PTFE belts, seals, etc.. In this sector alone, we are talking about trillions of packaging units/year and >100,000 jobs worldwide, which would endanger the global supply of packaging for food. | Part_1.docx | ||||||||||||
59 | 3907 | BehalfOfAnOrganisation | 2023/04/18 13:44 | Scope or restriction option analysis | United Kingdom | Company | Corrosion Resistant Products Ltd | Please refer to attached document "Section III Submission.pdf" | Specifically, we are commenting on the semiconductors, petroleum and mining sectors. In considering the possible replacement of PFAS by substitutes or alternatives as a response to any risk management action, it is necessary to consider their technical suitability, cost (economic feasibility), environmental and human health effects, as well as their capability to meet relevant required performance standards. For fluoropolymers and fluoroelastomers, the industry view appears to be that for many or most uses there are no alternatives with the requisite performance characteristics. PTFE / PFA fluoropolymer lined pipework and associated equipment are deployed on a global basis, safely transporting various liquids and liquified gases in bulk around a huge variety of manufacturing and processing sites, most of which are classified as dangerous goods or are otherwise potentially hazardous. These highly regulated industries, rely upon the PTFE / PFA fluoropolymer lined pipework and associated equipment to withstand extreme conditions in terms of corrosion and temperature as well as being versatile enough to be capable of handling many different types of media as processes change. PTFE / PFA fluoropolymer lined pipework and associated equipment must provide a range of technical properties that ensure the materials function as reliable and safe containment the respective chemicals. Fluoropolymer, materials such as PFA and PTFE, are widely used because of the proven properties of chemical resistance, temperature range, durability and vibration resistance. The exceptional properties of these lined pipe and associated equipment significantly impact on the operational safety and leak tightness record of the chemical process industry. Alternative lining element materials have been researched and in some controlled applications have been trialled but there is an overwhelming technical need to continue the use of fluoropolymers. There is a risk to the environment and the public should access to the totally reliable existing pipe lining element material be restricted. The material in this form does not shred or degrade into particles. Sealing elements have a long-life expectancy and are eventually safely disposed of as licensed industrial waste. Several trade bodies and associations have initiated a variety of programs to consolidate used materials and to seek recycling options. The safe containment and minimised contamination of chemicals is the prime consideration of the user of PTFE / PFA fluoropolymer lined pipework and associated equipment. This requires the use of lining and sealing elements with a critical range of properties and attributes. Essential operational properties of these materials include: • Chemical resistance and compatibility • Thermal stability • Durability Chemical resistance and compatibility Process and manufacturing industries use a wide range of chemicals which require the lining and sealing elements to be compatible over the range. This is achieved by currently the use of PTFE / PFA fluoropolymer lined pipework and associated equipment. Whereas some processes are dedicated to a specific chemical at a specific temperature, most are designed to be ‘flexible’ in their design to handle different substances according to production demand. The cost of labour, materials, and downtime to change pipework and associated equipment before each process change, should the current universally compatible lining and sealing elements not be available due to regulatory restriction, would be prohibitive. Furthermore, the need to change contaminated lining and sealing elements would result in an added safety risk to maintenance personnel and increased waste disposal. Thermal stability PTFE / PFA fluoropolymer lined pipework and associated equipment are manufactured to meet the general industrial required temperature range of -40°C to +200°C. These lining and sealing elements must therefore equally perform at these temperatures. Even if operating at ambient temperatures, certain corrosive chemicals are incompatible with alternatives fluoropolymer lined pipework and associated equipment. Furthermore, it is possible that such installations must be able to withstand high pressure water and cleaning fluid temperatures of up to 95°C and steam of about 160°C during the decontamination process. Some process and manufacturing industries require these chemicals to circulate at a variety of concentrations, temperatures and pressures depending on the role they are fulfilling which again calls for a versatile solution that currently only PTFE / PFA fluoropolymer lined pipework and associated equipment can provide. Durability Lining and sealing elements must be hard-wearing and be capable of withstanding a degree of handling damage as well as movement between different components. In addition, lining and sealing materials should not absorb the substances they transport. During maintenance programmes, absorbed substances which are often dangerous goods, are a safety risk to personnel undertaking works. In the manufacturing and process industries, chemicals are transported over relatively long distances, at height, often in difficult to reach areas of a factory and as such have limited access for frequent inspection. Lining and sealing elements once installed and tightened to the specified torque, must remain reliably leak tight. This means that the material properties are required to resist any compressive set which would allow vibratory forces to act on the fixings and consequently risk leakage. Semiconductor Sectors. As semiconductors become more complex, they require increasingly higher purity of etching acids (36x10-12 or 36 parts per trillion) in the manufacturing process. Consequently, metallic equipment cannot be used as wetted materials in this process hence lined pipe and equipment is necessary. At present ONLY PTFE or PFA lined products can provide the necessary characteristics required in terms of temperature (150°C) and corrosion resisting performance for these duties. Given the importance of this industry and the rate of its development, a ban or even a 12-year derogation would jeopardise the semiconductor manufacturing industry substantially. Petroleum and Mining Sectors. Again, the refining and transportation of petrochemicals and mining solutions require the use of chemicals that are incompatible with the majority of lined and unlined pipework. As in the semiconductor sector, currently there are no alternatives to PTFE/PFA lined pipework that can tolerate the varieties of substances, their varied concentrations and operating temperatures. At present it is unclear whether technically and economically feasible alternatives to PTFE / PFA fluoropolymers can be developed within a 12-year timescale. | It follows that the benefit of existing PTFE / PFA fluoropolymer lined pipework and associated equipment, which have a long-life expectancy and wide chemical compatibility, is that it reduces the frequency of pipe and valve element maintenance and replacement and therefore the quantity of items manufactured per annum and the quantity disposed. New material from manufacturing off-cuts and machining and drillings can be recycled. Used material recycling is currently problematic. However, some companies have developed methods for recycling PTFE. PTFE and PFA can be broken down into its constituent monomers, which can then be used to create new PTFE, PFA or other fluoropolymer materials. Another approach involves grinding PFA into a fine powder, which can be used as a filler in other materials. While these recycling methods are still in their early stages, they show promise for reducing the environmental impact of PTFE production and waste. | Incineration involves burning the PTFE / PFA fluoropolymers at high temperatures in the presence of oxygen, which breaks down the polymer into its constituent elements. However, it's important to note that incineration of PTFE can release toxic gases such as hydrofluoric acid and other hazardous air pollutants. Therefore, it's essential that PTFE / PFA fluoropolymers are incinerated in specialized facilities that are designed to safely handle hazardous waste. These facilities are equipped with advanced air pollution control technologies, such as scrubbers and filters, to capture and treat the toxic gases released during the incineration process. Overall, incineration of PTFE / PFA fluoropolymers can be a safe and effective way to dispose of the material when done in a controlled manner in specialized facilities that are equipped to handle hazardous waste with the heat created used to generate electrical energy. | Please refer to attached document "Specific Information Requests. 6 Missing Uses Submission.pdf" | Part_1.docx | https://www.industrydocuments.ucsf.edu/chemical/docs/#id=gkhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=fkhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=zjhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=tjhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=sjhv0346 | ||||||||
60 | 3908 | BehalfOfAnOrganisation | 2023/04/18 15:57 | Information on alternatives | Germany | Company | <redacted> | Yes | Sehr geehrte Damen und Herren, bei einem PFAS-Verbot wie es aktuell geplant ist, könnten wir im Bereich der Dichtungstechnik, und im speziellen der Gleitringdichtung auf dem Weltmarkt nicht mehr bestehen. Durch ein Verbot würde Herstellung in den asiatischen Raum verlegt werden. Viele unserer Kunden sind in Asien. Jedoch wird Stand heute zu 100 % in Deutschland produziert. Mit dem PFAS-Verbot in der jetzigen Form würden die Produkte schon sehr zeitnah in Asien hergestellt werden. Auch die sehr kurze Übergangszeit wird das abwandern der Produktion beschleunigen. | Unsere Produkte (Gleitringdichtungen und Rührwerke) kommen in den Bereichen Minning, Pharma, Food, Kunstoff, Chemie (eigentlich überall wo gerührt werden muss) zum Einsatz. | Die Verwendeten Produkte/Bauteile werden durch die Betreiber nach dem Austausch fachgerecht Entsorgt/Recycelt. | Mithilfe von Fluorpolymeren gelingt es Rührbehälter gegenüber der Atmosphäre abzudichten. | Part_1.docx | |||||||||
61 | 3909 | BehalfOfAnOrganisation | 2023/04/19 5:14 | Information on benefits | Japan | Company | Tokyo Zairyo Co,.Ltd, | 岡村成（Shigeru Okamura） | Fluoroelastomers are the only elastomers that can withstand temperatures above 200°C and have almost no volatility. Silicone rubber cannot be used at temperatures above 200°C for long periods of time, and its volatile components can cause insulation problems in electronic components. | Currently, VMQ is the main basic material for TIM(Thermal Interface Material), but its heat resistance is limited, and in the case of electronic components, there is an insulation problem due to volatile components; as SIC semiconductors and other devices will generate more heat every day, FKM (fluoroelastomers) with higher heat resistance and almost no volatility will become indispensable. There is no alternative to FKM. | FKM-based TIM material can be separated and made into powder particles for use as a fluoropolymer modifier. The modified fluoropolymers can be used as high-performance electronic substrates. It can also be recycled as a thermoplastic elastomer, and due to the thermal stability of fluoropolymers, it can be recycled many times. | This use should be exempt from regulation. The use of TIM is not in direct human contact and is far less volatile than other materials. | There is no alternative material due to the high temperatures at which neither silicone nor EPDM can be used. Fluoroelastomer is non-toxic. | Part_1.docx | https://www.industrydocuments.ucsf.edu/chemical/docs/#id=lxhv0346 | |||||||
62 | 3910 | BehalfOfAnOrganisation | 2023/04/19 11:30 | Scope or restriction option analysis | Sweden | Company | Dometic | bernt | The proposal include some derogations that preferably would require strict definitions to avoid ambiguity and potential loop holes. We have identified the following unclarities: • Transport refrigeration – and specifically if this sub-use would include all type of transports on land, on sea and in air, and if there is any limitation on what type of good is transported and refrigerated. • Mobile Air-conditioning - and specifically if this sub-use is equal to products within the scope of the MAC-Directive or if any other mobile air conditioners would fall under the proposed derogation. • Mobile – and specifically if this would have the same understanding as in the F-gas Regulation: “normally in transit during operation” We appreciate if clear definition could be included in the legislation and furthermore that such definitions are fully aligned with those found in other relevant legislation covering products in scope. | Our comments is applicable for the following sectors and (sub-) uses: • Applications of fluorinated gases including the sub-uses Refrigeration and Air conditioning and heat pumps • Transport including the sub-use HVACR- systems | a) For all type of equipment provided by Dometic (examples with some product information is listed in Annex B of the attached public information), extended product responsibility applies and is outlined in the WEEE and ELV directives depending on the product applications. Both these directives prescribe a full reclaim of refrigerants at end-of-life. As provider of products we are participating in the relevant recycling systems and provide end-of-life operators with relevant product information. The actual performance level of the end-of-life collection n and treatment is however, out of our control. We would not like to make any assumptions but encourage you to take direct contact with operators in the end-of-life chain for more information. Emissions of PFAS refrigerants might also appear in small quantities during product manufacturing and during the use-phase of products (accidental leaks). We will come back to you later in this consultation with more details on these emission as confidential information after consulting internal sources. b) Refrigerants reclaimed at end-of-life should be incinerated at high temperature to decompose the molecules. The actual performance level for these steps is out of our control and we have no further information. | Dometic is not affected by the proposed derogation and consequently we have no information to share here. Information under our requested derogation is found under Q6. | We don’t see that the use of refrigerant for several mobile and portable application of refrigeration and air-conditioning - other than transport refrigeration and car air-conditioning - have been assessed in the proposal. With reference to details below, we therefore request a new derogation with the following suggested wording: “Refrigerants for refrigeration and air-conditioning in recreational vehicles, trucks, boats and passenger cars (with the exemption of those within the scope of Directive 2006/40/EC of the European Parliament and of the Council), and in portable cooling boxes, until 6.5 years after EiF”. This sub-use may be sorted in under the use sector “Applications of fluorinated gases” or under “Transport” For this use we respond on the detailed questions as follows: a) On the tonnage and emissions: The main PFAS refrigerants for this use are R134a, R1234yf and the blends R410A, R407C, R417A and R404A. We would like to respond to you in a later stage on the tonnage and an estimation for the emissions at manufacturing and use phase related to products placed on the EU market. However, we would already now like to comment that for this use the concerned products on the EU market are covered by extended producer responsibility according to the WEEE Directive or the ELV Directive. Following these directives, any refrigerants must be reclaimed and treated separately at end-of-life. The actual performance level of the collection and end-of-life treatment facilities is however not within our control. For emissions during production and from leaks during the use phase we will come back to you with more accurate figures later in the consultation. b) On type of PFAS: PFAS is present as refrigerant for this use. c) On the market: This use include a wide range of different products and also many different providers for individual products. Some sub-uses are dominated by import from many small providers. Dometic is the major provider of this type of product on the EU market. To give you a better understanding of the market situation we will provide you with more confidential details later during the consultation. d) On alternatives in general: Because of the diversity of products and applications for this use, the alternatives to PFAS refrigerants also vary significantly. Furthermore, the legal situation is different for different markets, an important aspect for us as a global provider of products. We see mainly flammable hydrocarbons (R600a and R290a) – classified as A3 refrigerants - as alternatives for the smaller hermetically sealed products, and potentially CO2 for bigger ones. R32 could technically be an alternative for air-conditioning applications but will not meet the GWP threshold of the new F-gas Regulation. The alternatives present different challenges. For the hydrocarbons this is mainly the safety concerns and the need for a deep safety assessment. Leaking refrigerants could be ignited with risk of fire and explosion. For CO2 the bottleneck is the availability of components, but also the challenges related to the very high pressure. We will elaborate on the alternatives more in detail under question 6d and 6e below. Dometic is already in the process of analyzing the introduction of alternative refrigerants for its products. Some products, with limited safety hazard, is already in the process to be implemented on the market converted to new refrigerants. This include some refrigerators with small refrigerant charge aimed for larger recreational vehicles (RV) and minibars to cruise line ships. We have also notices that some competitor have introduced some products for RV containing hydrocarbon refrigerants on the EU market. For most of the products though, the conversion in still in a planning phase. e) On alternatives not yet available: We consider CO2 to be a potential future alternative for some of our larger chillers and air-conditioning units mainly for marine applications. Existing products operate on the blends such as R410A and R407C. We don’t see conversion to flammable A3 refrigerants being an option for these product because of the big refrigerant charge in combination with boat installations. Potential leaks in boats are critical and could cause both explosions and fires. In marine application also a small fire could cause a major accident with limited, or no, escape options. The major challenge with CO2 in our applications is the availability of components, specifically compressors, in suitable sizes for our applications. Furthermore, CO2 require a significantly higher system pressure that both possesses safety risks and risk of lost performance because of the high input power needed. The higher system pressure will also increase weight of the components. A lower efficiency and a higher weight will inadvertibly increase the energy consumption which is very unattractive from a climate perspective. No compressors for Direct Current (DC), required in mobile application, are available today for CO2. Dometic has not started any activities related to CO2 as refrigerant more that theoretical studies. We estimate that the development process will take minimum 5-8 years assuming that the component developments continue to progress. f) On alternatives where substitution is technically and economically feasible but more time is required: For most of the hermetically sealed products our plan is to move to flammable hydrocarbon refrigerants. Technically we know that this is feasible and the availability of components is good. However we have strong concerns on the safety aspects related to risks of igniting leaked refrigerants. Important considerations here are: 1. The products are often installed in confined spaces like small vehicle and marine application where also leakage of a limited refrigerant chare could present a significant risk. Air-conditioning units for trucks is one type of products that we identified as critical. We as a product provider do not fully control how the products is installed, used and stored, and information in manuals in manuals is often not followed by the user. 2. Portable products, like cooling boxes, are by definition flexible and could be stored and used in many confined spaces, like wardrobes, in small boats or in the car truck. The free volume in these places is often too small to dilute a leaked refrigerant charge and consequently a spark could ignite the refrigerant with severe consequences. 3. Mobile devices are per definition subject to significantly more vibration than stationary refrigerators, freezers, air conditioners and other appliances due to intended use. Therefore the risk of leakage is also higher for mobile products. To reduce the risks several options exist like minimizing the refrigerant charge, elimination of components with sparks, minimize tube joints (risk of leakage), sensors to detect leaks etc. Furthermore, simulations and real test could be used to understand the concertation levels of refrigerant at leak condition in the installation. Fault tree analyses is a tool we use to assess the risk associated with leaked refrigerants. Products safety standards consider safety aspects on flammable refrigerants and has shown to be a powerful tool to design safe products. However, safety standards for refrigeration products do not consider the safety aspect related to the environment where the products are used or stored. As mobile and portable products have a different use case than domestic products we have identified this as a potential risk. The overall most critical bottleneck for us is related to the development time, because of the huge number of products that need redesign and safety assessment. The example products provided in Annex B of the attached document show some major product categories. These in turn are spitted on many individual models families, models and stock keeping units (SKU). We estimate that approximately 240 different models and 890 SKU’s must be converted to new refrigerant. i) It is at this stage difficult to predict detailed costs associated with the substitution, but generally speaking cost will appear both in relation to products (development costs, additional safety components, certification, extended safety assessments, field tests), manufacturing sites (new installations, safety monitoring systems, training) on the market (training, marketing material) and at end-of-life. Cost for product development is depending on the number of products (models) that should be converted. We could provide you with a cost estimate in a later stage of this consultation as confidential information. ii) Time to re-design products and fully implement new refrigerants vary significantly between product categories. We estimate that most of our products could be converted in the time frame of 3-6 years depending on complexity and the number of models that must be converted. It can however not be ruled out that our risk assessment for some products will come to the conclusion that flammable refrigerants are not possible to introduce. iii) We do not see that new refrigerants should affect the product performance or life time significantly. Slightly increased energy consumption could not be excluded for some products because of safety monitoring systems. Due to safety concerns we might also need to limit the approved use for some products. We however foresee that the product price will increase because of increased safety measures such as sealed electrical components and systems to monitor leaks. We estimate that these additional costs will be in the area of 10-20% increase. g) We are not yet in a position to determine if the transition to non-PFAS refrigerants will be successful on all products in our range, and therefore it is difficult to make any assumptions. In the event the transition will fail because of safety aspects, technical or economic reasons, concerned products have certainly to be phased out from the EU market, but not necessarily from other markets. Our manufacturing is split on EU and non-EU, and similar products produced in EU are sold on many markets. Products not conforming to the new requirements, and sold to non-EU markets, must therefore be produced outside EU if we would like to keep them available. We have so far not elaborated with figures on potential loss of job opportunities, or economic consequences, for these events. | Part_1.docx | https://www.industrydocuments.ucsf.edu/chemical/docs/#id=mxhv0346 | |||||||
63 | 3911 | BehalfOfAnOrganisation | 2023/04/19 11:54 | Scope or restriction option analysis | Germany | Company | <redacted> | Yes | We therefore apply for a general derogation of measuring and process devices, which can`t be substituted within a short time frame (less than 10 years). A limitation to special applications or industries is not feasible, due to numerous uses at our customers. A short time substitution with the currently on the market available alternatives, will result in a shorter lifetime and limited specification of the devices. With this, prices of the manufactured products with the devices will increase or cause shortages for consumer products and critical materials like petrol or pharmaceuticals. Nevertheless, a broad restriction of applications and materials in the EU, will have a massive impact on the business of European companies and may result in shifting of R&D and manufacturing sites. Employees will be blocked with redesign instead of innovation. With this, the strength and attractiveness of Europe will decrease and result in a loss of employees and disadvantage in a global value chain. | Measurement devices (for flow, pressure, temperature, level, analytical parameter, …) are used in various applications of process industries (e.g. chemical industry, food&beverage, pharmaceutical industries, life sciences, oil&gas, mineral&mining, …) and have to follow standards (IEC, GMP, CSA, ASME, EHEDG, Ex...) which require tests and approvals of instruments according these standards. To substitute a part containing PFAS, a redesign of an instrument including a requalification of the usability in the application is necessary. The time period needed for a redesign of a product is much longer than the suggested transitional period of 18 months. More details can be found in the attached document. | (a) For tonnages and further detailed information see confidential attachment (b) The PFAS in these application (e.g. PFA, PTFE and others) are mostly used because of their resistance against temperature and strong chemicals and the unique combination of both. Also, they provide the needed good isolating characteristic, the non-stick property and a significant longer lifetime than the existing alternatives for limited, selected applications. (c) To our current knowledge, we estimate at least more than 100 companies in process operation and surveillance will be affected. (d) The described characteristics result in a much more durable and longer lifetime (e.g. 15 instead of 5 years), which reduces costs for the user of the devices, as well as for the end-user. With a shorter lifetime of alternative materials used in the devices and a resulting more often change of the devices, the price level for the manufactured consumer products will increase and bring a less sustainable way of production with much more waste, through changing the electronic devices regularly. The available materials with their current tonnages on the market, will lead to supply shortages, especially for smaller companies. With the ramp-up and qualification of new materials, the R&D process can easily take up to 10 years and more, also see attachment. (e/f/g) see confidential attachment | measurement products (for flow, pressure, temperature, level, analytical parameter, …) used in various applications of process industries and labs (e.g. chemical industry, food&beverage, pharmacytical industries, oil&gas,…) | Part_1.docx | |||||||||
64 | 3912 | BehalfOfAnOrganisation | 2023/04/19 15:04 | Hazard or exposure | Germany | Company | <redacted> | Yes | COG is a manufacturer of elastomer seals with specialised expertise in the field of fluorine-containing polymers. These polymers are used worldwide in demanding applications, for example, in medical technology, the food and pharmaceutical industries, and also in the energy sector (hydrogen, electrolysis, photovoltaics, wind energy, etc.), in semiconductor production and generally in mechanical engineering. Either no or only considerably inferior alternatives exist for these applications. For example, high-purity FFKM polymers are used for sealing in the semiconductor industry (wafer/chip production). Alternative materials for these applications do not exist at this time. The same applies to many production facilities in the pharmaceuticals industry. For example, the very purest water (WFI=water for injection) is used here in production so that medications and pharmaceutical products such as insulin of high purity can be produced. In addition to media resistance to WFI and the product, the special FKM material used here features a low migration rate that cannot be matched by any fluorine-free alternative material in this combination. A general PFAS ban would cause tremendous problems in other segments of the pharmaceuticals industry as well, because alternative materials do not come anywhere close to current service lives. For example, a production facility that currently has a service life of 250 hours could only operated for approximately 90 hours with an alternative material. Production costs would therefore rise significantly due to increased seal wear and additional production stops. Safe alternative elastomer materials for many sealing applications currently do not exist in medical technology or the food industry either. The problem is further exacerbated by the approvals required for pharmaceuticals and the food industry (FDA, USP, ISO 10993, 3-A Sanitary, etc.). While these approvals can be obtained for alternative materials that can be considered from a technical perspective, they do not meet the necessary application criteria such as WFI resistance. A general ban on PFAS for polymers in the sealing technology field would set the technology back by decades and endanger the safety of products and applications. The climate goals set by the EU and Germany for renewable energy can only be realised on the basis of fluorine-containing polymers. Furthermore, the (per)fluorinated rubber material group sets itself apart with high temperature resistance. Alternatives in the corresponding temperature ranges do not exist at this time. This is made clear in particular by the ASTM D2000 chart on page 64 of the attached PDF file. The temperature range covered by fluorinated compounds is coloured blue, notably in reference to high temperatures. This diagram shows that only fluorine-containing sealing materials exhibit a corresponding high thermal stability. They are compared here to other typical sealing materials that are not fluorine-based. VMQ materials are not a suitable alternative since they cannot be used in certain fields because of resistance to media. The table on page 63 of the attached PDF file present the common acids: sulphuric acid, hydrofluoric acid and nitric acid. Here the perfluorinated material FFKM is compared to the typical non-fluorinated sealing materials. This clearly shows that only a fluorinated material (FFKM in this case) can be used in applications with the acids in question. Reliable sealing for these chemicals, ensuring that they cannot escape into the environment, requires the use of this material. An undifferentiated PFAS ban would not only have serious negative economic consequences for COG, but could threaten the company’s existence. As of 2021/2022, materials based on fluoropolymers (FKM, FFKM, FEPM, FVMQ) account for more than 62% of the company’s sales. If these sales were to be eliminated by a general PFAS ban, only a small proportion could be made up by other materials such as HNBR or VMQ. There are no alternatives to FKM and especially to FFKM sealing materials. COG would have to dismiss at least 150 employees out of its current staff totalling nearly 300. Since fixed costs based on existing sales budgets cannot be eliminated, the PFAS ban could also threaten the company’s existence because generating sufficient compensating sales quickly is not possible. | Food contact materials and packaging (Annex E.2.3.): Subuse: Industrial food and feed production Differentiating between polymers and non-polymers in the PFAS context is absolutely essential and meaningful: Fluoroelastomers are considered non-toxic, not bioavailable, not water-soluble and non-mobile. The OECD (Organisation for Economic Co-operation and Development) defines criteria for “polymers of low concern”, summarised as follows: Fluoropolymers that meet the OECD criteria for “polymers of low concern” have insignificant environmental and human health impacts. The stability of fluoropolymers results in unique and lasting performance in many uses and applications. Furthermore, the unique durability of fluoropolymers makes them ideal materials to enable innovations. Fluoropolymers should be exempted from all regulatory measures within the scope of the REACH restrictions. In the pharmaceuticals sector, this good compatibility is proven by test reports (USP <87>, ISO 10993-5 and <88> as well as 10993-4 found in the appendix pages 4 to 62). Examples of tests that were performed include cytotoxicity, material implantations under the skin and compatibility tests with blood (haemolysis test). FKM performed very well in all these respects. Furthermore, many fluoroelastomers have been approved for food applications after testing (FDA). The FDA approvals for two polymers (Viton GF200S and Aflas 100S) are found in the appendix pages 1 to 3. | We produced 70 tons of FKM in 2022. | Part_1.docx | ||||||||||
65 | 3913 | BehalfOfAnOrganisation | 2023/04/19 18:05 | Transitional period | Germany | Company | AP-Miniplant GmbH & Co. KG | We are a manufacturer of scientific test plants for the process industries and renewable energies. We use components containing such substances mainly for sealing and piping material. Especially for the sealing and for the piping of highly aggressive substances we have no alternatives. Currently you would find these materials in 100 % of our individually manufactured research plants. Without the availability of such products we are currently not able to continue our business. | Manufacture of metal procucts not addressed elsewhere, PTFE thread sealing tape Fluoropolymer applications Energy Sector - PEM membranes | When we deliver a system, we instruct the user to use the recyle pathes given when decommissioning our units. We do not know if this actually happens. We know that components as a whole are reused for other purposes. But since our customers know the components and are experts in chemistry, it should be relatively easy to recycle or professionaly deposit the material. | As mentioned before, we think that in our field it is possible to responisbly deposit the components in our units. | We are using such materials in small amounts, mostly less than 10 kg per year. There is no emmission from our side and very little emmission during the lifetime of our units. That is why we think an exeption is necessary for research purposes or better generally for chemical production plants. | We use mainly sealing material like PTFE, FKM, FFKM, PFA, FEP, PVDF. In a few cases we can replace them by other plastic products such as EPDM, NBR, PA, PP, PE or Silicone. But in most cases chemical resitance or temperature problems force us to use fluor-polymer products. Without these it is not possible to build our systems. | We do not see chemical resistant alternatives on the market by now. To develop new material alternatives, for example our units are needed. And these units can only be build with such materials, as long as no alternatives are available. If we do not have it, we have to stop our business activities. | Manufacture of metal products not addressed elsewhere, PTFE thread sealing tape, Fluoropolymer applications: See above, we do not have alternatives Energy sector - PEM membranes: No information on this topic. | Part_1.docx | ||||||
66 | 3914 | Individual | 2023/04/20 10:03 | Scope or restriction option analysis | | | The materials concerned are essential for the industry, especially for the manufacture of semiconductors. On the one hand, the EU wants to localize the production of semiconductors in Europe and is investing 43 billion euros, and on the other hand, the European Parliament wants to ban the materials needed for this. I see a big contradiction there. I think such a decision will have massive consequences for the EU economy and its competitiveness. | For use to deliver cleaning & desinfecting chemicals in : Food and Beverage industry Semiconductor industery Chemical Industery Laundries , Resaturants and Hotels | If chemicals that can only be used with this plastic are not used, there is a risk that the desired public hygiene effect will not be achieved. This will have a great influence on the spread of diseases that could result from the lack of hygiene in the production of food. | Part_1.docx | ||||||||||||
67 | 3915 | BehalfOfAnOrganisation | 2023/04/20 11:11 | Scope or restriction option analysis | Germany | Company | <redacted> | Yes | We appreciate the intent to drastically reduce the negative effects of our industry on our nature and environment. In general, we believe it is the right approach to restrict PFAS. This comment is aimed to highlight two critical aspects in this restriction, do make sure it is done the right way. 1) the restriction MUST BE globally valid. IF its not, suppliers will buy PFAS from ASIA or elsewhere and make fortunes with these trades. As a result, our environment is still harmed in equal extents, yet EUROPE is once more boosting the ASIAN or other foreign economies. IF restricting PFAS globally is out of the powers of ECHA, well then it is not the right time yet to deploy that restriction. 2) Please make sure, that the restriction is focusing on the correct group of PFAS, especially considering the molekular composition of the material. As per our research, FKM should not be considered an equally dangerous material compared to other PFAS. In trust that ECHA is making the right choices here. Best regards Dennis Behnisch | See point 1 above. | Part_1.docx | |||||||||||
68 | 3916 | BehalfOfAnOrganisation | 2023/04/20 11:42 | Scope or restriction option analysis | Romania | National Authority | <redacted> | Yes | Fluoropolymers play an important role in numerous technologies and industrial processes: medical applications, defense & aerospace, automotive (including e-vehicles), hydrogen, semiconductor, and energy – including nuclear. Considering the socio-economic value, on the other hand, fluoropolymers are polymers of low concern for human health and the environment. | Part_1.docx | ||||||||||||
69 | 3917 | Individual | 2023/04/20 13:48 | Hazard or exposure | | | I would like to highlight one effect of PFAS’s that never seems to be mentioned: the hazard to birds. It’s been known for decades (the 1970’s) that having birds in the same space with PFAS fumes can be fatal. This has been seen in pets (canaries in kitchen area, ‘teflon toxicosis’) and fowl (e.g., chickens exposed to PTFE-coated heat sources). Further, the substances may be harmful to avian reproduction. I’m listing a few sources below (many more are also available online). Interestingly, even the Teflon brand warns about the toxic effect: https://www.teflon.com/en/consumers/teflon-coatings-cookware-bakeware/safety/bird-safety https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3276392/ https://www.vet.cornell.edu/animal-health-diagnostic-center/news/polytetrafluoroethylene-ptfe-teflon-toxicosis-ducks https://tvmdl.tamu.edu/2021/05/05/polytetrafluoroethylene-toxicosis-teflontm-toxicity/ https://vcahospitals.com/know-your-pet/teflon-polytetrafluoroethylene-poisoning-in-birds https://www.ewg.org/research/canaries-kitchen Avian reproduction: https://cfpub.epa.gov/si/si_public_record_Report.cfm?dirEntryId=357537&Lab=CCTE Exposure and Effects of PFAS on Birds (figshare.com) https://www.serdp-estcp.org/projects/details/bc88c0f1-9dee-4c17-ac9c-2bb0ee1aa4fc/food-web-exposure-and-consequent-effects-of-pfas-on-birds https://www.diva-portal.org/smash/get/diva2:1137416/FULLTEXT01.pdf | Part_1.docx | ||||||||||||||
70 | 3918 | BehalfOfAnOrganisation | 2023/04/20 16:49 | Scope or restriction option analysis | United Kingdom | Company | <redacted> | Yes | Dear Sir, Proposed EU REACH Restriction of PFAS - Fluoropolymers As the Owner and Managing Director of Holscot Advanced Polymers Limited, I write to you to register our objection to the proposed EU REACH restriction of certain materials currently classified as PFAS, and to request that the proposal is modified, which I will justify in the following pages, to exclude Perfluoroalkoxy Alkane (PFA), Fluorinated Ethylene Propylene (FEP) and Ethylene Tetrafluoroethylene (ETFE). In line with the published public consultation schedule starting 22nd March 2023 and ending 22nd September 2023, I also register with you our request for a derogation from the restriction for our uses of the following fluoropolymers; PFA, FEP and ETFE, in the event that the modifications are not accepted. Who is Holscot Advanced Polymers and what do we do? Holscot is a UK Private Limited Company with registered offices in UK, Netherlands and Germany. We have manufacturing in England, Scotland and Netherlands. We buy PFA, FEP and ETFE Fluoropolymers and make/convert/manufacture these into a large portfolio of products, sold business to business. The products solve the technical problems of industry and greatly benefit society by using the amazing properties of these fluoropolymers that no other materials possess. Why we are opposed to the restriction ? The restriction is based on the grounds of materials persistence. Whereas the scope of EU REACH is to protect from harm, humans and the environment (article 68 (1) REACH. Persistence is not an indication of harm. Persistence is out of scope of EU REACH remit and as such their restriction of chemicals for the purpose of persistence is not valid. The restriction classifies PFAS as “Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom without any H/Cl/Br/I attached to it.” Whereas the harmful PFAS are a small subset of this classification. The chemical properties and risk associated with one chemical group does not transmit to every instance of that group when present in another polymer. The 1995 US Polymer Exemption Rule was introduced to prevent such blanket restriction which it deemed was unnecessary. Thus the risk associated with a group of concern must be proven in each instance of application in a polymer chemical. https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/polymer-exemption-new-chemicals The environmental and toxicological profiles are distinctly different in Fluoropolymers solids than the majority of other PFAS liquid chemicals. The assumption that chemical properties are transferred to every instance of occurrence is unfounded and as such the restriction is invalid. Annex 68 of the Proposed Reach Restriction requires that Fluoropolymers which “pose risk to human health or the environment that is not adequately controlled and needs to be addressed”. Fluoropolymers are inert and do not cause harm to humans or the environment. Fluoropolymers are used for medical applications where devices are inserted and remain in the human body. These have been in use for over 60 years which his proof of their lack of harm and toxicity to humans. https://www.nordsonmedical.com/Components-and-Technologies/Medical-Tubing/PTFE-Tubing/#:~:text=PTFE%20has%20been%20used%20in,is%20an%20ideal%20catheter%20liner. The CJEU has held that a risk cannot be purely hypothetical: “[ purely hypothetical risks based on mere hypotheses that have not been scientifically confirmed cannot be accepted. To make the maintenance of the authorisation of a substance subject to proof of the lack of any risk, even a purely hypothetical one, would be both unrealistic in so far as such proof is generally impossible to give in scientific terms since 'zero risk' does not exist in practice”. Fluoropolymers do not break down to form harmful chemicals, as has been proven by the Danish EPA. They have been classified as polymers of low concern as documented in the Society of Environmental Toxicology and Chemistry by BJ Henry published 9th February 2018. https://setac.onlinelibrary.wiley.com/doi/full/10.1002/ieam.4035 Fluoropolymers are also “food approved” by the FDA in America, so viewed as very safe to humans. Fluoropolymers are certified not to combust and are proven self extinguishing for example used in the fire proofing of wires. This is an established major use in high rise buildings World wide (“plendum cable”), this application alone uses 1000’s of tons of melt processable Fluoropolymers. Fluoropolymers meet the OECD Polymer of Low Concern (PLC) criteria. They are non-toxic, not bio available, non-water soluble and non-mobile molecules and are deemed as such to have no significant environmental and human health impact. https://www.oecd.org/env/ehs/oecddefinitionofpolymer.htm The proposed restriction plans enforcement through the concept of “use”. There are millions of uses of our products, many that we are not privileged to be informed about, owing to non-disclosure by certain customer and national bodies. So, the proposed method of restriction and derogation is unworkable. In summary, the proposed restriction is :- • Legally out of scope of EU REACH • Technically insecure • Seeks to regulate safe polymers • Acts in a manner that is un-enforceable The restriction of Fluoropolymers is illogical, irrational and unreasonable. Because it is outside of the legal scope of EU REACH the restriction will not stand up in a Court of Law and is not supported by scientific data )see Fluoropolymers and the Stockholm POP Criteria. I urge you to reconsider the proposed “blanket ban” on all PFAS chemicals and treat Fluoropolymers as a deserved separate group of chemicals and remove all derogation time limits as per my enclosed supporting “Derogation Request” documents: Jet Aeroplane Engine Protective Sleeves and Breathers FEP, PFA and ETFE covered “O” Rings General extrusions of FEP, PFA and ETFE tubing General extrusion of FEP, PFA and ETFE film FEP Protective Covers used in Lighting Applications Heat Shrink Roller Covers Heat Shrinkable FEP and PFA tubes and film for special applications eg: electric vehicle systems FEP Flange Shields Satellite Fuel Tank Containment in FEP Secondary Containment for industrial purposes including food and beverages Nuclear Waste FEP Secondary Containment Bags Vacuum formed structures in FEP and PFA Industrial Conveyor Belts in FEP Hose Liners in White Pigmented FEP ETFE Architectural Film structures FEP and PFA used for composite parts manufacture Holscot Group are dedicated to the environmentally safe use of melt processable Fluoropolymers. We continue to develop a closed loop/reuse cycle for our materials. Our division “Recycleflon” already recycles over 85% of our own scrap in FEP and PFA Polymers. We will seek ways to extend this facility to our customers “end of life” products and materials. Yours faithfully D N Joyce Managing Director and Owner Holscot Advanced Polymers Alma Park Road Grantham NG31 9SE UK | Jet Aeroplane Engine Protective Sleeves and Breathers FEP, PFA and ETFE covered “O” Rings General extrusions of FEP, PFA and ETFE tubing General extrusion of FEP, PFA and ETFE film FEP Protective Covers used in Lighting Applications Heat Shrink Roller Covers Heat Shrinkable FEP and PFA tubes and film for special applications eg: electric vehicle systems FEP Flange Shields Satellite Fuel Tank Containment in FEP Secondary Containment for industrial purposes including food and beverages Nuclear Waste FEP Secondary Containment Bags Vacuum formed structures in FEP and PFA Industrial Conveyor Belts in FEP Hose Liners in White Pigmented FEP ETFE Architectural Film structures FEP and PFA used for composite parts manufacture | "In manufacture" we recover and reuse 11% of our annual tonnage of fluoropolymer use and this figure is increasing year on year. Actual amounts are confidential. Fluoropolymers do not contain the harmful PFAS PFOA, PFOS, PFNA, HFPO-DA, PFHxS, PFBS. PFOA/PFOS. Certification can be supplied on request. (this runs to more than the permitted file size attachment) "In use" there are no emissions in the products produced by Holscot Advanced Polymers Limited, as these products do not degrade and are not water soluble. Therefore 0% emissions. Regarding the "End of Life Phase" phase Holscot Advanced Polymers Limited would be willing to accept end of life products to put through our recycling process. The current uptake from our customers has been low. | End of Life products can be safely incinerated in Ceramic ovens. Fluoropolymers do not contain the harmful PFAS PFOA, PFOS, PFNA, HFPO-DA, PFHxS, PFBS. PFOA/PFOS. Certification can be supplied on request. (this runs to more than the permitted file size attachment) | Fluoropolymers do not contain the harmful PFAS PFOA, PFOS, PFNA, HFPO-DA, PFHxS, PFBS. PFOA/PFOS. Certification can be supplied on request. (this runs to more than the permitted file size attachment) | Tonnage usage: 18% Lighting applications 30% O-rings (transport and industry) 14% Aerospace 24% General extrusions for Industrial applications 13% Other special applications 1% Hose liners Emissions are zero as fluoropolymers do not degrade. | We have a list of missing uses and submit exemption request for all of these, which are added as attachments. The alternatives have been considered as part of these exemption requests. Jet Aeroplane Engine Protective Sleeves and Breathers FEP, PFA and ETFE covered “O” Rings General extrusions of FEP, PFA and ETFE tubing General extrusion of FEP, PFA and ETFE film FEP Protective Covers used in Lighting Applications Heat Shrink Roller Covers Heat Shrinkable FEP and PFA tubes and film for special applications eg: electric vehicle systems FEP Flange Shields Satellite Fuel Tank Containment in FEP Secondary Containment for industrial purposes including food and beverages Nuclear Waste FEP Secondary Containment Bags Vacuum formed structures in FEP and PFA Industrial Conveyor Belts in FEP Hose Liners in White Pigmented FEP ETFE Architectural Film structures FEP and PFA used for composite parts manufacture | The assessment of these is covered in the documents attached, in summary:- i) Technically and economically feasible alternatives are not available. ii) The alternatives cannot be made ready by the implementation date, nor could they be qualified, certified or approved by the governing industry bodies. iii) alternatives do not exist | There are no viable alternatives, please see the exemption request documents attached. | Part_1.docx | ||||
71 | 3919 | BehalfOfAnOrganisation | 2023/04/20 17:42 | Scope or restriction option analysis | Austria | Company | <redacted> | Yes | Why Fluoropolymers in the Chemical Industry for sulfuric acid? Sulfuric acid (H2SO4) is the most widely used acid worldwide and essential for many industrial sectors (e.g. batteries, fertilizer production, production of other chemicals e.g. HF, semiconductor, metallurgical processes, …). A significant amount of the world wide used H2SO4 is produced using the welt sulphuric acid (WSA) process. To handle the highly concentrated H2SO4 during production as well as the hot flue gases, fluoropolymers are essential for an economic production (reduced maintenance and reduced down-time) and also essential for a safe and environmental friendly production during the whole live-time. When it comes to the chemicals industry, fluoropolymers allow for the safe production, storage, handling and use of chemicals through protective equipment and linings. Their chemical stability allows them to be resistant to some of the most corrosive substances on the market and as a result protecting works and equipment from harm. Production, storage, transport an use of chemicals and other hazardous materials can inevitably carry potential risks. Moreover, history has shown that accidents can not only have economic impacts, but also irreparable consequences on human lives and the environment. Mitigating such risks through rigorous safety management whilst simultaneously ensuring efficiency and availability is a major challenge for today’s worldwide chemical industry. In our view, the Annex XV restriction report does not cover relevant and essential uses of fluoropolymers in the critical sector “chemical industry”: Pipelines, storage tanks and transportation containers for the handling of chemicals because they are mechanically solid, chemically resistant and stable even in harsh and corrosive environments. | The specific Sector “PFA Fluorpolymers used in the WSA (Wet Sulphuric Acid) Sulphuric acid production” process is not listed in Annex XV. | Today most PFA raw materials are produced using fluorinated polymerization aids that may remain in extremely small amounts (ppm) within the PFA and have the potential to leach-out during the use phase. To reduce the risk of small molecular PFAS to be emitted from fluoropolymers, it is desirable to produce them without fluorinated polymerization aids. Production: During the extrusion of sheets, pipes and welding rods, the PFA is heated up to about 370 °C and kept at this temperature for about 10 Minutes, before it is cooled down again. According to Drobny et al, we can calculate the emissions of PFA at the extrusion temperature of 370 °C as follows: 33500 kg * 0.004 %/h /100 *10/60 = 0,22 kg Extruding products from about 33500 kg of PFA, is expected to lead to about 0.22 kg of low molecular emissions according to Drobny at al. One should not forget these emission are mainly composed of HF, thus only a fraction of the 0.22 kg/year have the potential to be PFAS. In our facility critical production areas like extruder, extrusion die and calender-rolls are covered with a ventilation hood to suck off possible low molecular substances and HF. The processing gases are afterwards cleaned via a gas scrubber before released into the atmosphere. Measurement show, that low molecular PFAS accumulate in water used in the gas scrubber, thus it is proven that they are removed from the off gases collected above the extrusion line. Usephase During the use phase the PFA is used at a maximum temperature of 260 °C (sometimes it is lower and only temporarily 260 °C is reached). Assuming the worst case of 260 °C, the following emissions can be expected from PFA according to Drobny at all during the lifetime of 15 years: 33500 kg * 100*10^-11 %/h /100% * 24 * 365 * 15 = 0.044 kg Considering that this is the worst-case scenario at the topmost application temperature and that not all of the 0.044 kg are PFAS, but mainly HF, the release of PFAS into the environment is negligible during the whole use phase. Additionally, it is expected that the emission are not constant, but are slowly decreasing during the life-time. That the emissions caused by PFA are negligible becomes very obvious when looking at the data presented by ECHA during the webinar on April 5th 2023: Emissions from fluorinated gases, emissions from textiles or emissions from medical devices are expected to be in excess of >>1000 t each year. Thus, restriction need to focus on applications that cause most of the emissions. End of Life: Equipment which is decommissioned after service life (~ 10-15 years depending on the application) will be deopsited under strict governmental rules (hazardous waste) in dedicated landfills or will be incinerated. PFA Products are stable and will not degrade to small molecular PFAS. | a) • Due to the increasing environmental regulations the demand of WSA production units is constantly growing. The WSA process efficiently removes sulfur from flue gases to meet todays emission regulations in sulfuric acid production as well as waste incineration plants and power plants. b) The publication Fluoroplastics as Corrosion Protection in Flue Gas Desulphurization Units (VGB Power Techn 4/2007, paper attached below) explains why PFA is successfully used in this specific applications: • Long term chemical resistance of PFA against condensating sulfuric acid (>96 %) at operation temperatures of about 260 °C as well as other acids and chemicals present in the flue gas • Test report Exposure Testing Swerea Kimab (attached to submission) • Official Letter “Freudenberg” Lifetime >10 years (attached to submission) • A long-term leak proof lining system can be achieved under these critical operation conditions • The PFA lining offers simple repair options since the sheet can be welded again after proper preparation in the case of mechanical damages. • Increasing the efficiency of the WSA plant due to an increase in reliability and increased availability (reduced maintenance) Customer Project report attached => Information about annual tonnage is provided in the attached, confidential document c) In principle, all chemical companies which are using this type of equipment and that are involved in the production and use of sulfuric acid. Additionally, those who build and plan the facilities + producer of the components (like PFA semi-finished products). Affected industrial applications in general: Refinery and petrochemical industry, Metallurgy industry, Coal based industry, Power industry, Viscose industry, Sulfuric acid industry, Production of fertilizers, Semiconductor industry and all users of sulfuric acid d) In the past a multilayer construction was used consisting of the following materials: • Chemical stone lining (direct media contact) • Foam glass layer • Non-welded PTFE sheets (secondary layer) • Chemical protection layer (coating) • Steel tank as a mechanical structure Experience has shown that this multilayer construction is not creating a long-term and leak proof lining system. As a result corrosion of the carbon steel tank by the condensing sulfuric acid happens after a few years (e.g. 3 years). As a result, frequent maintenance and repairs are required. Eventually, it is necessary to remove the lining system, which is already soaked with acid, at great safety expense and to refurbish the steel structure and lining in a further step. As no long-term leak proof lining system can be generated with this multilayer structure, plant safety is reduced significantly. Additionally, the plant availability and reliability is reduced significant due to frequent maintenance intervals See OMV Project report attached. All materials of this alternative can be purchased in Europe, except the PTFE foil, which could be banned by the PFAS restriction process as well. High-alloy steels like Hastelloy, Inconel and also Titanium, Zirconium are not chemical resistant against the stated operation conditions (Condensing, Fuming Sulfuric Acid at operation temperature of 260 °C); Source/Reference used: Compass Corrosion Guide II Furthermore it is referred to publication in the Sulphur Magazine (number 358, May-June 2015) that explains the chemical resistance of fluoropolymers against sulfuric acid and evaluates possible alternatives. g) Banning PFA would not only cause harm to our business and the business of our suppliers, but to all companies and end users in the chemical industry. Considering that alone the market of sulfuric acid is worth about 13 billion € per year, the effect of banning PFA could have a substantial impact on the whole value chain. Without the WSA production technology the environmental requirements of the SOx exposure can not be fulfilled. In addition, the availability of sulphuric acid in Europe is reduced. Sulfuric acid is used most used acid world wide, used in various applications like (Fertilizer Industry, Chemical industry, Semiconductor industry, metallurgical industry) Negative impact on EU Strategies, Sustainable Development Goals: Semiconductor industry, E-Mobility | Part_2.docx | |||||||||
72 | 3920 | BehalfOfAnOrganisation | 2023/04/20 17:52 | Scope or restriction option analysis | Germany | Company | <redacted> | Yes | Scope or restriction option analysis: The definition of the PFAS family is too broad, as it also includes substances that do not have hazardous properties or pose unacceptable risks, such as fluoropolymers. The inclusion of fluoropolymers in the restriction proposal violates the principle of proportionality. Restricting the use of fluoropolymers will have a huge negative impact on society in the EU. Due to the excellent heat and chemical resistance of fluoropolymers without components of PFAS, the existence of many important industries in Germany and the EU would no longer exist. Baseline: PTFE, PVDF, PFA approximately 42 tons per year subcontractor for mechanical and plant engineering, mainly chemical industry Chemical pumps for the semiconductor industry and battery separators Chemical pumps for pumping media for the pharmaceutical industry Shut-off devices in highly corrosive plants (flue gas desulfurization) Sealing elements Other socio economic analysis (SEA) issues: Loss of 15-50 jobs Drop in sales of up to 10% Dismantling of machines and plants and associated costs. Loss/collapse of the entire European business location. Relocation of production to Asia or other countries that do not address the issue. Due to the excellent heat and chemical resistance of fluoropolymers without PFAS components, the existence of many important industrial sectors in Germany and the EU would no longer exist. Transitional period: From our experience, we can say that for possible substitution, transition periods of several years are necessary to establish alternative products ready for series production. Due to the complexity of the supply chains involving fluoropolymers, a restriction process based on exemptions will not be implemented by the relevant industrial stakeholders. Request for exemption: Fluoropolymers form a special group of substances within the PFASs, since their properties are completely different. These substances are considered as polymers of low concern, and their use therefore poses no risk to human health or the human health and the environment. For this reason, a comprehensive exemption for this group of substances should be considered under the PFAS restriction proposal. | a) 10t PVDF, 30t PTFE, 2t PFA b) outstanding heat- and chemical resistance c) 30 companies in direct relation to our company d) Products are very high price. If cheaper alternatives had the same effect, the cheaper alternatives would certainly be used. In the case of a ban on fluoropolymers for industrial applications, the entire European machinery and plant engineering industry would collapse. Complete sectors of the economy would relocate production to non-European countries. Exceptions are not known. e) Alternatives are not know yet and not possible today. We are supplier for the chemical industry where R&D-procedures require approval times of several years. In addition to a possible transformation phase, further regulatory and/or product-specific approvals and certification steps must be carried out. The ban of PFAS must be considered independently of fluoropolymers such as PTFE/PVDF/PFA, where manufacturers have already addressed this in recent months and years and can produce the fluoropolymers PFAS-free. f) no substitution is known g) Loss of 15-50 jobs just at our company Drop in sales of up to 10% Dismantling of machines and plants and associated costs. Loss/collapse of the entire European business location. Relocation of production to Asia or other countries that do not address the issue. | Part_2.docx | |||||||||||
73 | 3921 | Individual | 2023/04/20 21:05 | Information on benefits | | | I support the proposal. It is necessary. | Use of PTFE in plastic in most electrical products is wide and often not necessary. It can be substituted. Of course we need to compromise that products may get bigger, cost more or not have all features as of today. The way we design and produce most products is not sustainable and does not cover the real costs. | PFAS is used in many applications in electronics. There are alternatives if required to change. | Part_2.docx | ||||||||||||
74 | 3922 | BehalfOfAnOrganisation | 2023/04/20 21:21 | Scope or restriction option analysis | Sweden | Company | Zound Industries | We support the restriction. A total ban is necessary to change the industry to substitute pfas and find alternatives. | PFAS is used in 100s of applications in electronics, as most hard plastics, rubber, sealants, tapes and oil. Also, a lot of PFAS is used to meet too high flammability requirements. It is also necessary to modify safety standards on flammability requirements. | It is very hard to get information on pfas for manufacturers so recyclers can not only trust this. Therefore a total ban is required. | There are alternatives for many uses in consumer electronics. We are willing to make compromises because the way products are designed and produced today is not sustainable. | Part_2.docx | ||||||||||
75 | 3923 | BehalfOfAnOrganisation | 2023/04/21 10:34 | Scope or restriction option analysis | Germany | Company | BAUM Lined Piping GmbH | There is a broad consensus in this organisation that a large number of PFAS should be banned or limited. The environment is over-polluted - and none of us wants to fall ill. In this respect, we fully support the initiative. However, there is not only one type of "PFAS”. There are some that are dangerous and toxic. They are what it is all about. However, there are also long-chain compounds that are very persistent and do not dissolve, and therefore do not represent an immediate risk to the environment. These compounds are non-toxic, non-mobile and therefore do not accumulate. However, particular attention needs to be paid to the production and, of course, to the end-of-life management of these substances and to a safe disposal or to a recycling system that does not release PFAS compounds into the environment. These are a small number of fluoropolymers, which, in our opinion, represent a clear exception: PTFE, PFA, ETFE and FEP. These substances will be discussed in more detail below (document #0.03). These fluoropolymers are used extensively in industrial plants in the chemical/agricultural and pharmaceutical industries. This is not about the "end products" that are produced in these plants, but rather about the so-called "pre-production". The chemical reaction stages at the very beginning of the production line. To the "average person" these applications remain hidden, as they are not seen in the context of end products. It is, however, the basis of all production processes in which, for example, substances have to be dissolved or cracked to obtain intermediate products from which the final products can be made. In this respect, the 'Chemical/Pharmaceutical' sector under discussion is very similar to the 'Petroleum and Mining' sector, although much larger and more important to the European economy. One example is the use of sulphuric acid, which is also used in mining to extract metals from rocks. Other examples are hydrochloric acid or nitric acid. Even though highly aggressive, these processes have become indispensable in industrial production. However, your draft lacks a detailed consideration of the chemical/crop science and pharmaceutical industries, as you yourself document in your report Annex A, Table A1. However, the value of these industries to the European economy is immense, as shown in the attached document #0.01. For reasons of fairness, we therefore advocate a more intensive analysis of the areas of "industrial applications in chemical/crop science and pharmaceuticals", which have received little attention to date. It is therefore a question of combination: - Additional area: "industrial plants in chemicals, CropScience and pharmaceuticals" - Related to: Fluoropolymers, in particular PTFE, PFA, ETFE and FEP and their applications. The following two papers are intended to provide evidence and documentation of the safety of fluoropolymers, while at the same time demonstrating the enormous importance of the chemical and pharmaceutical industries, which should be given additional consideration in the draft. Part 1: deals with the ECHA draft dated 22.3.23 in relation to "Chemical/CropScience and Pharma", document #0.02 Part 2: deals with fluoropolymers, in particular PTFE, PFA, ETFE, FEP; document #0.03 We are therefore concerned with fluoropolymers (in particular PTFE, PFA, ETFE, FEP), which are on the one hand "polymers of low concern" (non-toxic, non-mobile, non-soluble and non-accumulative), represent closed material cycles, have no serious alternative in the usual high-temperature industrial applications and, if banned, will have serious socio-economic consequences; On the other hand, to be prohibited as there are concerns due to persistence. However: Where "persistent" materials are technically required, and these are precisely those chemical applications, they can only be reasonably replaced by other persistent materials (if replacement is possible at all). It would seem to make more sense to work towards the proper disposal or recycling/reuse of fluoropolymers, as recycling and recirculation processes already exist (successfully), but may not yet be widespread. Hence our proposal: 1. Fluoropolymers, in particular the four fluoropolymers PTFE, PFA, ETFE, FEP identified by the IEAM, should be completely excluded from the ban procedure. 2. The industrial sector / industrial applications in the Chemical/CropScience and Pharmaceutical sector should be examined just as accurately as the other 14 classified sectors, in accordance with its value in the European economy, a derogation should also be established here. BAUM lined piping GmbH See documents Non-confidential #0.01, Confidential #0.02 Confidential #0.03 | SECTOR: Chemical industry In fact, our comments refer to a sector, which is „not researched in detail“. This sector is „chemical industry“ according to Annex a, Table A1. We would vote to call this sector „Chemical, CropScience and pharmaceutical industry“. SUB-USE: Fluorpolymers In this sector, Fluorpolymer lined pipes, fittings, columns and vessels are widely used as they are persistant against the used agrressive medias in those industry production. Persistance is here the key function. Especially PTFE/PFA/ETFE/FEP are fluoropolymers of low concern, as they are non toxic, insoluble in water, does not accumulate, not hazardous to men and environment (see document #1.01, non-confidential attachments). Please see hereto also: document confidential #2.14 Conversio study | Please have a look at the Conversio study attached in „confidential attachments“ document #2.14 | Regarding End-of-Life emissions, we can only talk about Fluorpolymers. Incineration here is safe ( see non-confidential document #2.19), since HF-gas as product of emission can be recovered in a recycling pathway and can be re-used in new production of PTFE. Please see also document # 2.17a „Recycling of PTFE“ in combination of the EU report „JRC Science for Policy report – Best available Techniques Reference document for waste incineration“. WE have to admit, that this closed material cycle is not yet implemented worldwide, so it would need some regulation on that. Additionally, beside incineration, we would like to draw your attention on other – already existend ! – closed material-cycle pathways for Fluorpolymers, such as PFA and PTFE: PFA Recycling: BAUM is doing that successfully – all PFA production waste will be re-granulated by third party and this material is re-used in actual production. Please see non-confidential document #2.08 PTFE Recycling: Since 2014, there is a recycling plant existing (chemical park Gendorf, Germany), which recycles at an efficiency of 90% EOL PTFE into Monomeres, which will be re-used in new production. Please see non-confidential documents # 2.06 Gendorf and #2.07 InVerTec | As you can find under „general information“ comments from our side, we believe, chemical industry (or more precise: Chemical/CropScience/Pharma Industry) should be implemented in the derogations (the most similar field is listed at 6f „fluoropolymer applications in petroleum and mining industry“. As an answer to your question 5 we propose the implementation of: 6 g.) fluoropolymer applications in chemical/CropScince/pharma industry BAUM amount of fluoropolymers in production per anno: 300 to x 86% = 255 to The remaining material (14%) goes to: 6 f.) fluoropolymer applications in petroleum and mining industry BAUM amount of fluoropolymers in production per anno: 300 to x 9% = 27 to xx.) fluorpolymere applications in energy / hydrogen production BAUM amount of fluoropolymers in production per anno: 300 to x 5% = 15 to | Missing uses: chemical industry – more precise: Chemical/CropScience/Pharma Industry Please refer to confidential document #2.14 Conversio study a. In 2020 / EU: chemical/pharma industry 14,4 kto fluoropolymers in use/ 11,5 kto collected waste (which is 80%) b. Key functionalities of fluoropolymers in those industries is the persistance against almost all organic acids. Fluoropolymers are in use as lining for pipelines, vessels, columns and reactors for all chemical processes in that industry. As the work with high aggressive media is hazadorous and dangerous, fluoropolymers protect men,equipment and environment from damages. With their wide range of functionalities (chemical resistance, working temp from -60°C up to 230°C, persistant over decades) there are no real alternatives covering the whole range of functionalities. c. We can only answer for BAUM GmbH: we have more than 2500 customers who will be effected by such a restriction. Please see confidential document #2.01 „BAUM Kundenliste“ d. For alternatives, please refer to confidential document #0.03 point 3 and confidential document #2.15 e. We do not see a realistic upcoming alternative to fluoropolymers, as the key function „persistance“ can only be replaced by other „persistant“ product. f. ----- g. For socio-economic impacts in case of a restriction, please check: i. Confidential attachment document #0.03 point 4 ii. Confidential attachment document #2.14 Conversio study iii. Confidential attachment document #2.15 Chemservice study iv. Non- Confidential attachment document #2.16 Final SEA | As you can find under „general information“ comments from our side, we believe, chemical industry (or more precise: Chemical/CropScience/Pharma Industry) should be implemented in the derogations (the most similar field is listed at 6f „fluoropolymer applications in petroleum and mining industry“). So we propose the implementation of: 6 g.) fluoropolymer applications in chemical/CropScince/pharma industry Given this, we can say to your question 7 i.) PEEK could be an alternative regarding persistance and temperature ii.) PEEK is existing already iii.) Problem: PEEK is not available in required amounts to replace fluoropolymers, and extremely expensive (120 €/kg depending on requested amount, whereas PTFE costs 15-25 €/kg), see confidential document #2.20. On top, production of PEEK is very energy-intensive. However: This material is not yet being authorized for such applications. It needs further developments and long-run testings already from producer side. Further on, this material has to be tested on site under real conditions (this will take years). Additionally, Downstream-users have to implement that material into their own specifications, after successful testing, this is probably the hardest hurdle, as home-grown specifications were originated over decades of experience…….so estimated timeline is something between 10-20 years. Please see non-confidential document #2.02 PEEK confidential document #2.20 PEEK pricing | Already answered in question 6 and given attachement documents there Missing uses: chemical industry – more precise: Chemical/CropScience/Pharma Industry Please refer to confidential document #2.14 Conversio study a. In 2020 / EU: chemical/pharma industry 14,4 kto fluoropolymers in use/ 11,5 kto collected waste (which is 80%) b. Key functionalities of fluoropolymers in those industries is the persistance against almost all organic acids. Fluoropolymers are in use as lining for pipelines, vessels, columns and reactors for all chemical processes in that industry. As the work with high aggressive media is hazadorous and dangerous, fluoropolymers protect men,equipment and environment from damages. With their wide range of functionalities (chemical resistance, working temp from -60°C up to 230°C, persistant over decades) there are no real alternatives covering the whole range of functionalities. c. We can only answer for BAUM GmbH: we have more than 2500 customers who will be effected by such a restriction. Please see confidential document #2.01 „BAUM Kundenliste“ d. For alternatives, please refer to confidential document #0.03 point 3 and confidential document #2.15 e. We do not see a realistic upcoming alternative to fluoropolymers, as the key function „persistance“ can only be replaced by other „persistant“ product. f. ----- g. For socio-economic impacts in case of a restriction, please check: i. Confidential attachment document #0.03 point 4 ii. Confidential attachment document #2.14 Conversio study iii. Confidential attachment document #2.15 Chemservice study iv. Non- Confidential attachment document #2.16 Final SEA | Part_2.docx | https://www.industrydocuments.ucsf.edu/chemical/docs/#id=flhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=zkhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=tkhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=skhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=rkhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=qkhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=pkhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=ykhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=nkhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=lkhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=kkhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=jkhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=xkhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=hkhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=mkhv0346 | |||||
76 | 3924 | Individual | 2023/04/21 13:54 | Request for exemption | | | Please see attached Letter and supplementary documents. | Please see attached Letter and supplementary documents. | Part_2.docx | https://www.industrydocuments.ucsf.edu/chemical/docs/#id=jlhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=xlhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=hlhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=glhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=klhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=llhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=nlhv0346 https://www.industrydocuments.ucsf.edu/chemical/docs/#id=mlhv0346 | ||||||||||||
77 | 3925 | BehalfOfAnOrganisation | 2023/04/21 14:42 | Environmental emissions | Belgium | Industry or trade association | RECHARGE | Alina Lange | High performance, advanced rechargeable and lithium batteries: • Lithium-ion rechargeable batteries (also known as Li-ion batteries) • Lithium (Li) primary batteries (also known as primary Lithium batteries) • Nickel–based rechargeable batteries (Ni-Cd and Ni-MH) • Metal air batteries • Zinc oxide batteries • Silver oxide batteries • Sodium-ion (Na-ion) rechargeable batteries • Zinc-ion (Zn-ion) rechargeable batteries • Solid-state batteries • Lithium metal rechargeable batteries • Other battery technologies currently under research | See attached document | See attached document | See attached document | See attached document | See attached document | See attached document | Part_2.docx | https://www.industrydocuments.ucsf.edu/chemical/docs/#id=ylhv0346 | |||||
78 | 3926 | BehalfOfAnOrganisation | 2023/04/21 17:07 | Scope or restriction option analysis | Norway | International organisation | <redacted> | Yes | To include the fluoropolymers within the scope of all PFAS does not respect the principle of proportionality. Fluoropolymers are OECD polymers of low concern; they are widely used in many applications and markets. For the manufacturing of fluoropolymers nowadays NON-fluorinated process aids are also available. Fluoropolymers are mostly used when no other materials are technical possible due to the unique material properties, see for example analyses for the automotive industry in the attachment. A limitation will cause in the automotive industry a huge negative impact, due increased safety risk for vehicles, not meeting emission legislations of NOx, particles and HC and hindering downsizing of drivelines / engines, thus not meeting CO2 legislations/ fuel reductions. Also from a waste, recycling point and avoiding they remain in the environment the content of the fluoropolymers on a vehicle is very very low compared to other plastics on the vehicle. Thus very limited effect if they will be banned, whereas developing alternatives in the automotive industry ( more than 7-10 years) will have a larger negative effect. | Transport sector (and off road vehicles and stationary engines ) | see attachment. Fluoropolymers like PTFE and ETFE are often used for hoses and tubes to transfer fluids (water, oil, biofuel) or gases (air, exhaust) on On-road and Off-road engines and vehicles. Normally for safety- and emission critical applications and harsh conditions. As cost is a key driver in the automotive industry and Fluoropolymers are relative expensive, they only will be designed in when no other alternatives are present. To develop and also to validate alternatives, it will mean to use different technologies for the function/ system and this will take by the OEM's a long time , ie more then 7 - 10 years. No short /midterm drop- ins are available due to the increasing tighter legislations for fuel and emission reductions, which driving downsizing of engines, more emission reduction systems and hybrids. This all leads to increasing operating temperatures, flexible hoses and tubes due to tighter routing cq space constraints on engine and vehicles and the requirement to reduce weight of vehicle and component driving the need for fluoropolymers like PTFE and ETFE. | Part_2.docx | https://www.industrydocuments.ucsf.edu/chemical/docs/#id=plhv0346 | |||||||||
79 | 3927 | BehalfOfAnOrganisation | 2023/04/24 4:56 | | Japan | Company | <redacted> | Yes | gasket packing | Part_2.docx | ||||||||||||
80 | 3928 | Individual | 2023/04/24 8:32 | Other socio economic analysis (SEA) issues | | | We are manufacturing high precision parts for the aviation industry. Since we use aerospace material PTFE+bronze, we ask for further examination if the mentioned material is really that harmful as stated in the proposal of the ECHA. Further defferentiation should be carried out. | While machining aerospace material PTFE+bronze, machines are secured and vacuumed. Therefore, every output is filtered before releasing it to the environment. | We are machining round about 0,5 tonnes during 3 years of aerospace material PTFE+bronze bar material | Regarding the raw material marked cost increase were significantly during the recent year. A restriction regarding raw material will have a further (negative) impact on the development of costs. This will also automatically have an impact on productivity and thus profitability. | Part_2.docx | |||||||||||
81 | 3929 | BehalfOfAnOrganisation | 2023/04/24 11:12 | Scope or restriction option analysis | Italy | Company | CDR Pompe S.r.l. | EUROPUMP | 1. Scope or restriction option analysis: Including fluoropolymers in the restriction proposal does not meet the goal of protecting human health and the environment. Fluoropolymers are used in many applications where dangerous, hazardous, corrosive or pure fluids are handled and where metallic or “traditional” plastic materials fail to meet the requested duties, in terms of corrosion resistance, liquid adsorption or contamination of pure substance. For example, most fluoropolymers such as PVDF, are capable to pump concentrated sulfuric acid where most of metal made components fail to met the requested chemical compatibility, causing increased risk of: 1. Leakage of hazardous media to the environment, with higher risk of pollution; 2. To the personnel involved in operating pumping equipment; 3. Increased plant operating costs, due to higher level of maintenance requested. Also, for pumping acetic acid, fluoropolymers are the best choice, for example PVDF offer the best chemical compatibility where all metallic pumps have chemical compatibility problems, leading again to increased risks of premature leakage of hazardous media, increased risk to operating personnel and increased maintenance costs due to less chemical resistance of metal made pumps. Other examples of pumped media that require fluoropolymers lining on pump components and cannot be pumped with metal alloys, without increased risks are: acetil-salicilic acid, benzoic acid, butyric acid, calcium acid sulfate, carbolic acid, carbonic acid, chloric acid, chloroacetic acid, chlorinated fluids, chromic acid in concentration from 1% to above 50%, formic acid etc. For reference on materials chemical compatibility see: https://www.graco.com/content/dam/graco/ipd/literature/misc/chemical-compatibility-guide/Graco_ChemCompGuideEN-B.pdf Banning all fluoropolymers means also producing or using less safe, reliable and durable fluid handling equipment in chemical processes, pharmaceutical processes and in oil and gas industry, more prone to risk of leakages that can expose workers that operating on site to a major risk of serious injuries or short/long term health diseases, derived by came in contact with hazardous/dangerous media. Leakage coming from fluid handling equipment (pumps) can have adverse effects also on the environment, when moving hazardous, corrosive or dangerous fluids. Banning all fluoropolymers and having thus less reliable equipment, lead to a major risk of fluid handling equipment (pumps and gaskets) leakage, worsening the environmental footprint of chemical, pharmaceutical and oil & gas process plants. Instead of banning fluoropolymers we see it as more reasonable to regulate waste management of components in which fluoropolymers are present, in order to minimize environmental impact. 2. Hazard or exposure No data 3. Environmental emissions No data 4. Baseline Actual use of fluoropolymers, based on our data, is about 2600 kg/year divided mainly between PFA, ETFE, PVDF. Products delivered: a. Lined centrifugal pumps for corrosive/hazardous fluids. b. Mechanical seals for corrosive hazardous fluid containment. Sectors of use: a. Chemical process plants. b. Pharmaceutical process plants. c. Oil & gas. 5. Description of analytical methods No data 6. Information on alternatives Considering our main applications, for pumping acids like: hydrochloric acid, hydrofluoric acid, acetyl salicylic acid, chloric acid or chemicals like: bromine, fluorinated fluids, chromium and barium sulfate, chlorine and chlorinated water, fluoropolymers are the most consistent/unique choice of material lining because of their excellent chemical compatibility with these pumping media (liquids), low permeation rate and low degradation with respect to metallic materials. Considering non fluorinated polymeric material, they offer less chemical compatibility and narrower working temperature range compared to fluoropolymers. Considering production costs, both metallic materials and fluorine free polymers have higher production costs compared to fluoropolymers. For nickel-based alloy, for example, raw material costs are 3 to 5 times higher than PFA. If one keep in mind that, for lined pump components, the use of fluoropolymer is limited to maximum 3 kg when a component fully made of metal weigh 40 to 50 kg the price difference between the two components become more than evident. Given all the considerations above we see no alternative material that can substitute fluoropolymers in chemical process, pharmaceutical process and oil & gas sectors, both from technical and costing points of view. For more information on chemical compatibility of pumped media see reference: https://www.graco.com/content/dam/graco/ipd/literature/misc/chemical-compatibility-guide/Graco_ChemCompGuideEN-B.pdf 7. Information on Benefits Use of fluoropolymers as lining materials for pumps and fluid handling devices or gaskets allows to transport and store hazardous fluids like … with minimum risk for human health and environment, guarantees safe equipment operation and less maintenance and operating costs. From corrosion resistance point of view, components lined with fluoropolymers guarantee the highest level of durability compared to any metal made component, in pumping corrosive media. Fluoropolymers are also totally inert materials, that means: a pump lined with a fluoropolymer like PFA, PVDF or ETFE does not contaminate the pumped liquid, its purity remains unchanged. In addition to all the characteristics above, fluoropolymers can also withstand high temperature liquids, make lined pumps suitable to work in hot and harsh environments without containment fails, losses or leakages. Being more chemically inert and less prone to corrosion, fluoropolymers allow pump manufacturers to design and build lighter components with benefits to environmental impact (reference: https://vantonpump.com/tl-167-plastics-or-metal-which-material-is-right-for-your-pump/). Considering manufacturing effort, lined components (ETFE) emission is about 10 kg of CO2 for each EFTE kg, while nickel alloy components emissions are about 13 kg of CO2 emitted for each nickel alloy kg. Since lined components necessitate less material than nickel alloy components to be produced (a pump casing lined with fluoropolymer contains maximum 3 kg of EFTE, PFA or PVDF, when a metal made pump casing contains 40 to 50 kg of metal) the environmental footprint of fluoropolymers is a lot lighter than its metallic alternatives. (references: https://nickelinstitute.org/ , https://www.cableizer.com/documentation/EEC/). 8. Other socio-economic analysis No data 9. Transitional period Considering that today there isn’t any real alternative to fluoropolymers for hazardous and corrosive fluid handling applications and no recent developed new material has proven to have better characteristics of fluoropolymers in this fields, we think it is premature to fix time limits to the use of these materials. At the time of writing seems more reasonable to exempt all fluoropolymers from being banned. When there will be real and effective alternatives to these materials, in terms of corrosion resistance, hazardous substances containment and chemical inertness it will be possible to discuss again about fluoropolymers regulation. 10. Request for Exemption Since studies on fluoropolymers don’t highlight certain evidence of hazards for human health and are considered, unlike PFAS, of low concern, a broad exemption for this group of substances should be considered within the PFAS restriction proposal. | Oil & gas and mining, lined pumps and auxiliary equipment. | Sector: Chemical and Pharmaceutical process sector. Components involved: Lined pumps and auxiliary equipment. As specified in Annex XV restriction report for oil & gas and mining sector, also for chemical and pharmaceutical process plants, the only alternative to fluoropolymers for pumping hazardous or corrosive liquids are metallic materials, in particular special alloys like bronze or nickel alloys. As stated also in Annex E, paragraph 2.15 metallic materials used to substitute fluoropolymers are less flexible, produce heavier components and are more carbon intensive. Corrosion resistance and chemical inertness of metals are poorer compared to fluoropolymer materials, making them less suitable compared to fluoropolymers from a safety point of view, when handling corrosive, hazardous media or substances that must be kept at a high level of purity. Moreover, metallic pumps and fluid handling devices need gaskets capable of containing liquids pumped or handled. These gaskets need the same corrosion resistance and chemical inertness characteristics of the other parts of the pump, with the necessary elasticity to fill all the gaps between pump components, in order to prevent any fluid leakage from pump. Metals gaskets don’t meet all the requirement above, making them unsuitable to effectively contain corrosive or hazardous media. Composite gaskets are also unsuitable because often resins used to bond fibers can be attacked by corrosive media. Rubber based alternatives suffer at temperatures above 120 – 150 °C and chemical compatibility is not as broad as for fluoropolymers. Considering pump lined components, the alternative material proposed in the Annex E, paragraph 2.15, aren’t suitable for temperatures higher than 150 °C and chemical compatibility is not as broad as for fluoropolymers. Given the motivation above, it is clear that: any of the alternative material specified for example in Annex E 2.15, that should be used to substitute fluoropolymers as materials for lined components or gaskets, present an increased risk of leakage, premature failure or degradation of pump/gaskets components, causing hazardous, toxic or corrosive media release to the environment, with high risk also for personnel working with this machinery. Since at the time of writing there are no valid alternatives to fluoropolymers and it is not foreseen any big development in the very next years, the request is an exemption for fluoropolymers used in chemical processing plants equipment and pharmaceutical processing plant equipment. Banning fluoropolymers in chemical and pharmaceutical process industry will impair European capacity to produce intermediate products necessary constituents of all drugs actually on the market, moreover the dismantling of drugs, fertilizers and other chemical process plants, would lead to unemployment of more than 400 000 operators, considering also the supply chain and depriving Europe of a strategic sector. | Sector: Chemical and Pharmaceutical process sector. Components involved: Lined pumps and auxiliary equipment. As specified in Annex XV restriction report for oil & gas and mining sector, also for chemical and pharmaceutical process plants, the only alternative to fluoropolymers for pumping hazardous or corrosive liquids are metallic materials, in particular special alloys like bronze or nickel alloys. As stated also in Annex E, paragraph 2.15 metallic materials used to substitute fluoropolymers are less flexible, produce heavier components and are more carbon intensive. Corrosion resistance and chemical inertness of metals are poorer compared to fluoropolymer materials, making them less suitable compared to fluoropolymers from a safety point of view, when handling corrosive, hazardous media or substances that must be kept at a high level of purity. Moreover, metallic pumps and fluid handling devices need gaskets capable of containing liquids pumped or handled. These gaskets need the same corrosion resistance and chemical inertness characteristics of the other parts of the pump, with the necessary elasticity to fill all the gaps between pump components, in order to prevent any fluid leakage from pump. Metals gaskets don’t meet all the requirement above, making them unsuitable to effectively contain corrosive or hazardous media. Composite gaskets are also unsuitable because often resins used to bond fibers can be attacked by corrosive media. Rubber based alternatives suffer at temperatures above 120 – 150 °C and chemical compatibility is not as broad as for fluoropolymers. Considering pump lined components, the alternative material proposed in the Annex E, paragraph 2.15, aren’t suitable for temperatures higher than 150 °C and chemical compatibility is not as broad as for fluoropolymers. Given the motivation above, it is clear that: any of the alternative material specified for example in Annex E 2.15, that should be used to substitute fluoropolymers as materials for lined components or gaskets, present an increased risk of leakage, premature failure or degradation of pump/gaskets components, causing hazardous, toxic or corrosive media release to the environment, with high risk also for personnel working with this machinery. Since at the time of writing there are no valid alternatives to fluoropolymers and it is not foreseen any big development in the very next years, the request is an exemption for fluoropolymers used in chemical processing plants equipment and pharmaceutical processing plant equipment. Banning fluoropolymers in chemical and pharmaceutical process industry will impair European capacity to produce intermediate products necessary constituents of all drugs actually on the market, moreover the dismantling of drugs, fertilizers and other chemical process plants, would lead to unemployment of more than 400 000 operators, considering also the supply chain and depriving Europe of a strategic sector. | Sector: Chemical and Pharmaceutical process sector. Components involved: Lined pumps and auxiliary equipment. As specified in Annex XV restriction report for oil & gas and mining sector, also for chemical and pharmaceutical process plants, the only alternative to fluoropolymers for pumping hazardous or corrosive liquids are metallic materials, in particular special alloys like bronze or nickel alloys. As stated also in Annex E, paragraph 2.15 metallic materials used to substitute fluoropolymers are less flexible, produce heavier components and are more carbon intensive. Corrosion resistance and chemical inertness of metals are poorer compared to fluoropolymer materials, making them less suitable compared to fluoropolymers from a safety point of view, when handling corrosive, hazardous media or substances that must be kept at a high level of purity. Moreover, metallic pumps and fluid handling devices need gaskets capable of containing liquids pumped or handled. These gaskets need the same corrosion resistance and chemical inertness characteristics of the other parts of the pump, with the necessary elasticity to fill all the gaps between pump components, in order to prevent any fluid leakage from pump. Metals gaskets don’t meet all the requirement above, making them unsuitable to effectively contain corrosive or hazardous media. Composite gaskets are also unsuitable because often resins used to bond fibers can be attacked by corrosive media. Rubber based alternatives suffer at temperatures above 120 – 150 °C and chemical compatibility is not as broad as for fluoropolymers. Considering pump lined components, the alternative material proposed in the Annex E, paragraph 2.15, aren’t suitable for temperatures higher than 150 °C and chemical compatibility is not as broad as for fluoropolymers. Given the motivation above, it is clear that: any of the alternative material specified for example in Annex E 2.15, that should be used to substitute fluoropolymers as materials for lined components or gaskets, present an increased risk of leakage, premature failure or degradation of pump/gaskets components, causing hazardous, toxic or corrosive media release to the environment, with high risk also for personnel working with this machinery. Since at the time of writing there are no valid alternatives to fluoropolymers and it is not foreseen any big development in the very next years, the request is an exemption for fluoropolymers used in chemical processing plants equipment and pharmaceutical processing plant equipment. Banning fluoropolymers in chemical and pharmaceutical process industry will impair European capacity to produce intermediate products necessary constituents of all drugs actually on the market, moreover the dismantling of drugs, fertilizers and other chemical process plants, would lead to unemployment of more than 400 000 operators, considering also the supply chain and depriving Europe of a strategic sector. | Part_2.docx | https://www.industrydocuments.ucsf.edu/chemical/docs/#id=qlhv0346 | |||||||
82 | 3930 | BehalfOfAnOrganisation | 2023/04/24 14:35 | Scope or restriction option analysis | Germany | Company | se cover GmbH | We work with ETFE as a cladding product in the construction industry. Such claddings last for 20 years and are emission free. ETFE is full recyclable at its life's end. Furthermore it represents a minor fraction of Fluoropolymer on the European market- Nevertheless should the PFAS be activated a complete industry in this area of construction / architecture in Europe will be annihilated and the same products will be eventually bought from non-European countries. | Architecture / Construction | We have minimum emmision as we need to dismantle the product and send it to a recycling facility. | The product will not be incinerated | Our company may use up to 20tons per year | Should PFAS be activated our entire company is in real danger to be shut down | Due to the minor impact of our use of PFAS and the major impact on our industry, we would appreciate a derogation for the use in the architectural / construction industry | We do not have alternative products | Part_2.docx | ||||||
83 | 3931 | BehalfOfAnOrganisation | 2023/04/24 17:21 | Baseline | Germany | Company | ViscoTec Pumpen- und Dosiertechnik GmbH | For many substances of the PFAS group a restriction is necessary without any doubt facing their well-known negative impact. However, with special regard to fluoropolymers, these materials are non-toxic, non-bioaccumulative, non-bioavailable and non-mobile in the aquatic environment, but there are many important applications for which so far, no alternative for these materials is known or presents an adequate substitute once they are applied under harsh conditions [1-2]. A couple of fluoropolymers and their use are crucial to achieve certain goals of the European society and hence, their unqualified restriction would rather cause high negative impact on the whole society and put the independence of Europe in danger than provide a risk reduction. Consequently, there should be an exemption for certain fluoropolymers needed in elemental applications where feasible alternatives are not expectable. The core competence of our company comprises highly specialized, miniaturized progressive cavity pumps, based on eccentric screw (rotor) and a rubber-based stator. The rubber is a key component for the pump principle (well known as the Moineau-principle). Such pumps are widely used in almost all production areas for goods of- modern daily life! From aerospace industry, wind turbine or solar panel fabrication, production of mobile devices, the car industry (especially electric vehicle, fuel cell, battery technology), food, medical or pharmaceutical production – all these sectors have the need of volumetric dispense pumps in their production where in most cases these pumps and dispensers are indispensable . For some applications, the stator material can be chosen from non-fluorinated materials (we use them wherever possible), but currently most applications require a high-performance stator either made from poly- (FKM, FEPM) or perfluorinated elastomer (FFKM) due to its outstanding chemical resistance required under harsh conditions (predominant case for most customers). Likewise, our sensors (also FFKM) and most gaskets and hose linings (PTFE) as well as greases (PTFE) and protection foils (ETFE) are made from fluoropolymers. Moreover, some of our pump housings made of stainless-steel need additional protective anti-stick coating which is currently also a fluorinated polymer coating. Our pumps and peripheral devices are widely used to dispense abrasive and chemically aggressive media, e.g. organic solvents, acids and bases, or acrylic based adhesives, paints, soldering pastes and sealants as well as cosmetics, or sauces, flavors etc. in the food and pharmaceutical industry. All bonding applications – which are also required to produce e.g. catheters, pacemakers or respiratory masks – need to be supported by volumetric dosing pumps. Since prospectively there is no alternative material which provides the excellent chemical and thermal resistance of certain fluoropolymers along with the required mechanical properties (applies particularly to fluoroelastomers), many of our customers would no longer be able to perform their applications. Consequently, at least 90% of all our customers (about 3500 worldwide and approx. 900 in Europe) would be directly affected, and we would have to cut about 150 jobs (approx. 55% ) while facing sales losses of approx. 40-60 million euros . On the other hand, the total tonnages of fluoropolymers we apply are less than 1 t/a without causing any traceable PFAS emissions to the environment. Hence, we find that a full restriction of these fluoropolymers in almost all technical applications would be in no relation to the highly negative socio-economic consequences. Thus, we request for an exemption for certain technically important fluoropolymers applied in such low amount, since these polymers entail a rather low risk to human health and the environment. This must be clearly distinguished from other PFAS which are dangerous and/or rather easy to replace. Nonetheless, we see the big problem of persistent materials and regarding recycling, we plan to offer a recycling strategy to our customers where we take care of the end-of-life phase of the employed fluoropolymers to ensure an eco-friendlier life cycle. Literature sources: [1] B.J. Henry et al., Integr. Environ. Assess. Manag., 2018, 14, 316-334. [2] S.H. Korzeniowski et al., Integr. Environ. Assess. Manag., 2023, 19, 326-354. | Food contact materials and packaging – Industrial food and feed production Lubricants – Sector as a whole | - Paragraph 5 (s) lubricants used under harsh conditions: PTFE-based greases are used in our pump systems (less than 0.1g per pump) to protect our shaft sealing rings and gears from aggressive media (acids, solvents, etc). We apply less than 2kg per year and since the grease is firmly installed inside the pump with very little contact to media the emission to environment is negligibly low. We can say this since even after many 100k of runs and after years in use the grease is still present inside the pump. - Paragraph 6 (a) food contact materials: Some of our pump systems are used in food production (e.g., to apply tomato sauce onto the pizza) and there we need the fluoropolymer FFKM as stator and seal material, since – to our knowledge – it is the only material which withstands the harsh cleaning cycles applied in hygienic area (20% NaOH, organic acids, special solvents, steam at temperatures up to 140 °C and autoclavation). The tonnages we need are less than 10 kg per year! Moreover, there are no PFAS emissions which we can attribute to this FFKM rubber which is a vulcanized polymer material. | Fluoropolymers: Thermoplastics and rubber/elastomer used in gaskets, stator material, O-rings, protective foils, shaft seals, sensor membranes, hose linings, anti-stick protective coatings – wherever the material needs to withstand very harsh conditions. In our case: materials needed to produce our pumps, dispensers, emptying systems, fluid supply and treatment systems and sensors. (a) PTFE, ETFE, PVDF and FKM, FEPM, FFKM rubber: tonnages in total less than 1t/a and well below 0.5t/a in Europe and without identifiable PFAS emissions during our rubber and pump production or use. (b) Excellent chemical resistance and inertness, high temperature resistance, bio-resistance, and resistance against degradation by hydrolysis. In the case of elastomer additionally: mechanical properties (elasticity, abrasion resistance, etc.) required in a stator of a progressive cavity pump used under harsh conditions. To demonstrate the benefits of fluoroelastomers we have attached the results of some chemical resistance tests with different materials (see confidential attachments). (c) All companies in this sector would be directly affected: approx. 15 firms ; and almost all the customers (in our case globally approx. 3500 companies and about 900 in Europe, B2B only; plus, many customers of our competitors). (d) So far, there are no alternatives available on the world polymer market which can adequately replace fluoroelastomers (especially not the FFKM rubber) and only few alternative high-performance materials which can be used in seal applications (e.g. gaskets) like PEK/PEEK are available. Wherever possible, we try to use such an alternative. (e) Since 2016, we have been actively looking for alternative materials and recently a 10-month research project starting from 02/2022 with an investment of about 10,000 Euros was focusing on thermoplastic elastomers (TPEs). However, the materials were unable to achieve sufficient resistance against chemical attack while providing the required mechanical properties. The achievement of these two requirements are the major challenges in finding alternatives, especially for the fluoroelastomers. Therefore, we are strongly dependent on the elastomer market and the availability of feasible materials which are currently not foreseeable. Moreover, once an alternative elastomer becomes available, we would need to re-evaluate and properly adjust our dosing systems since their reliability and precision is crucial to our customers. For this, we expect another 2-5 years of R&D until market introduction and another 1-3 years for our customers in their individual evaluation processes with 2-3 years in the area of food and pharma applications. (f) Currently the substitution potential cannot be adequately estimated. (g) In contrast to many other PFAS, the impact of a restriction on fluoropolymers would strongly affect all companies and sectors where these high-performance materials are irreplaceable at present. As a result, consumers as well as the whole European society would be negatively affected once certain products and key technologies would cease and significant losses of jobs and growth would become reality. In certain cases, a persistent material is required to withstand the operating conditions and any alternative material would also need to be persistent to fulfill this criterion. This is more a question about proper end-of-life management. As an example, one of our customers applies our pump systems to dose the right amount of firefighting foam into the extinguishing water in fire-fighting vehicles. To withstand this concentrate, a FEPM elastomer and PTFE seals are used inside the pump. Moreover, another two customers apply acrylate-based adhesives in the production for medicinal products such as masks or catheters where only FFKM elastomer was acceptably resistant against the acrylates. To produce solar modules, another customer needs our dosing pumps for grouting the junction box and uses a silicone rubber where the hardening component very aggressively attacks our stators. We have tested several materials but only a FFKM elastomer was applicable (see confidential attachments). These are only a few examples where our products make a significant contribution to key European industries from which the whole European society benefits. | Part_2.docx | ||||||||||
84 | 3932 | BehalfOfAnOrganisation | 2023/04/26 8:39 | Scope or restriction option analysis | Japan | Company | <redacted> | Yes | Printing plate Printing image forming equipment uses PTFE and PFA in the parts that come into contact with the printing plate. The reason for this is to prevent the surface of the printing plate from being scratched by the contacting parts with respect to the coating (printing image formation) surface applied to the printing plate. The use of PTFE and PFA is essential and cannot be replaced. Therefore, please exempt "printing plate printing image forming equipment for printing". | 5. By way of derogation, paragraphs 1 and 2 shall not apply to: x. [industrial and professional use of solvent-based debinding systems in 3D printing until 13.5 years after EiF]; y. [industrial and professional use of smoothing agents for polymer 3D printing applications until 13.5 years after EiF]; | Part_3.docx | |||||||||||
85 | 3934 | Individual | 2023/04/26 14:06 | Scope or restriction option analysis | | | Dear Madams or Sirs, As can be seen from Table A.1 of Annex A, from my point of view several areas of application of substances containing PFAS are not considered in the present PFAS ban application. I would like to mention the following areas as examples: - the energy sector, especially the production of wind turbines or battery cells - the automotive sector - the mechanical engineering sector - the pharmaceutical sector PFAS-containing materials, substances and intermediate products are used in all these areas. Any substitutes must first be tested for a certain degree of suitability through lengthy trial phases, and I suspect that many substitutes cannot be classified as full substitutes. This reduces the longevity of the products, for example, or increases the maintenance effort. Both of these are detrimental to the environment (green footprint of the products) in my opinion. I am therefore convinced that if a comprehensive PFAS ban is implemented in accordance with the ban proposal, it will no longer be possible to manufacture products in the European economic area with the same properties. This would result in global economic disadvantages for Europe. The ban proposal follows the usual exaggerated "green way of thinking" at the moment and results in the destruction of the economic area of Europe. The rest of the "world economy" will then be happy about the deindustrialized Europe. I therefore call on the responsible bodies to reconsider this ban proposal and also to take into account the economic interests of the companies/manufacturers/large corporations based in Europe. In my view, a deindustrialized Europe cannot be the goal of this legislation. Thanks for your attention. | See general comments | See general comments | Part_3.docx | ||||||||||||
86 | 3935 | BehalfOfAnOrganisation | 2023/04/26 14:20 | Scope or restriction option analysis | Germany | Company | EM-Technik GmbH | Consultation EM-Technik GmbH EM-Technik GmbH is a medium-sizes company with ten subsidiaries abroad, employing 200 people. EM-Technik GmbH is a downstream user - producer of articles. We are using the processes of injection molding, welding and CNC-machining to produce high quality connectors and fittings made of special plastics. Partly in cleanrooms ISO 5 and ISO 7. Our products mainly of Fluoropolymers are widely used handling (connecting, shutting off, regulating, distributing) highly aggressive chemical gases or liquids at a high temperature. Key characteristics valued by our customers are high quality and absolute leak proofness at extreme conditions. For 57 years, 2000 customers worldwide trust in our technology and competences. Scope or restriction option analysis To start with, EM-Technik GmbH wants to clearly highlight, that our consultation is only concerning the Fluoropolymers. We strongly believe, that Fluoropolymers are a small group of nontoxic chemical compounds which should get exempt of the PFAS proposal of the EU. As it is already indicated in the dossier itself, the nontoxic and non-biodegradable Fluoropolymers are the major fountain of future megatrends, like the green deal, high speed 5G or e-mobility naming only a few of them. Without these materials the leakage of chemicals into the environment and the safety of employees and other people working with these substances could not get guaranteed. Further information in the confidential appendix Hazard or exposure EM-Technik GmbH collects and recycles all scrap parts and other plastic production waste. The purified regranulate is fed back into the production process to keep our production waste as minimal as possible. Further information in the confidential appendix Baseline EM-Technik GmbH is using the following Fluoropolymers (annual use stated in the appendix): Polyvinilidene fluoride (PVDF) Polytetrafluoroethylene (PTFE) Perfluoroalkoxy polymer (PFA) In all data sheets the Fluoropolymers are described as: “Not considered a hazardous mixture according to Reg. (EC) No 1272/2008 and their amendments.” (Confidential Appendix 4, Appendix 6, Appendix 7). Our role in the supply chain is: Without our products many industrial sectors would not be able to handle leak free highly aggressive liquids and gases of acids and alkalis safely. Our products are especially designed and manufactured to fulfil these specific needs of the industry. EM-Technik GmbH is involved in several branches and industries, however the major ones using Fluoropolymers are: Semiconductor, Wet chemicals, Chemical industry, Medical industry, Energy sector. Further information in the confidential appendix Information on alternatives Our products are widely used in applications in the semiconductor production process. The exposure to harsh chemicals, temperature and mechanical strength, limits the use of other materials. Many production standards do not allow metals or other plastics than plastics of high purity like Fluoropolymers. This is stated in: SEMI F57-0622 - (SEMI F57 - Specification for High Purity Polymer Materials and Components Used in Ultrapure Water and Liquid Chemical Distribution Systems). Key characteristics of the products are resistance in high temperatures, high pressures and high chemical resistances. Alternatives for Fluoropolymers such as polypropylene (PP), polyetheretherketon (PEEK) do not fulfil all these special requirements at ones. Therefore, we cannot offer our customers products made of alternative materials without risking tremendous consequences for environment or the health of employees. Further information in the confidential appendix Information on benefits With the ban of Fluoropolymers, future visions and megatrends such as the energy or traffic transition could not be achieved in Europe. Further information in the confidential appendix Other socio-economic analysis (SEA) issues EM-Technik GmbH wants to highlight again, that the ban of Fluoropolymers in Europe means a shift of the industries and the applications to other regions of the world. The ban of Fluoropolymers in the EU would lead to major devastation of our company. Further information in the confidential appendix Transitional period Fluoropolymers and our company as well are part of a complicated, heterogeneous and various supply chain. Since Fluoropolymer products are basically everywhere derogations for special uses or companies are too complex. Request for exemption EM-Technik GmbH demands a total derogation of Fluoropolymers for the business to business sector. | Part_3.docx | |||||||||||||
87 | 3936 | BehalfOfAnOrganisation | 2023/04/26 15:38 | Transitional period | Germany | Company | VITLAB GmbH | The envisaged time of 18 months from EIF will not be sufficient, even if we start already now to convert the entire product range. The qualification of alternative materials for the existing products is complicated and will take a lot of time. Especially because it could be also possible that the existing tools cannot be used with other materials for the manufacture of the products and a new construction will become necessary. We need a transitional period that is extended at least to 6,5 years after entry into force of the restriction for the use of fluoropolymers for the production of special laboratory equipment to be able to find possible alternative materials and to make it possible to produce with them our products. | Table A.1 in Annex A of the Annex XV Restriction Report lists in blue highlighted PFAS uses that have not been addressed in further detail, such as laboratory equipment. This includes, in our understanding, all laboratory equipment, e.g. equipment that is used in an analytical laboratory for product analysis in the food industry as well as in the pharmaceutical or petrochemical industry. The equipment is required for reliable examination of product quality and confirmation of product safety. These instruments are also needed to analyse various environmental samples (e.g. soil, water, ...). These can be spectrometers, chromatographs, dosing systems, burettes, pipettes or simply beakers, volumetric flasks, sample vials or tubes. We expressly emphasise that these products are intended for industrial use and have no application in the private environment. a. The laboratory market is a small but important market and has only a minor share of the 840000 tonnes of PFAS that enter the market annually. For our company, we process barely 2 tonnes of the fluoropolymer PFA p.a., which then go to the market as volumetric flasks, beakers and bottles. We cannot provide annual emissions. The waste generated during the manufacturing process is added back to the process directly at the machine, so that almost no plastic waste is produced. The manageable residual quantities go to certified disposal companies. b. The most important functions provided by PFA for the respective application is its high temperature resistance and chemical inertness. The raw material used is also particularly clean and contains no catalyst residues worth mentioning, a basic condition for to production of products for metal trace analysis. c. The number of companies manufacturing these products in the laboratory sector in Europe in particular and throughout the world is very limited. Besides us, there are perhaps less than ten manufacturers of these special laboratory devices in the world. d. There is no alternative material with equally good chemical properties. This is the state of the art and it is very likely that there will no such aquivilant material in future providing the same chemical features. However, there are alternative materials that could be used, but these materials offer poor performance and have a significantly shorter usage periods. When dealing with highly corrosive media, such as concentrated acids (HNO3, H2SO4, ...) or hydrofluoric acid (HF), which are used to digest solid samples, all other materials will quickly be destroyed or cannot be used at all (e.g. glass in the case of HF). The other materials also negatively affect the subsequent analysis due to contamination. This creates the risk of inaccurate analysis and incorrect analysis results. e. As the availability of alternative materials is not yet given and whether and when such a material will be available, it is also not yet possible to estimate whether supply problems with the potential alternative materials could be expected. f. We process currently the available material, which is produced by the chemical fluoropolymer industry. We have no data or indications whether the polymer manufacturers are already researching alternative materials and if and when an alternative could be expected. Therefore, as downstream user, we cannot provide any information regarding the following two points below. i. ii. iii. All currently available materials beside PFA are limited in their functionality and this may cource that users in the pharmaceutical analytical quality laboratory have to change a flask made of other materials more frequently.This will cource significantly higher effort. This is not only leading to increasing costs for analyitics, but also results in much higher amount of waste material. As the determination of specific toxid substances would no longer be possible on todays quality level the comsumer would also be negativly effected due to lower quality of analysis (e.g. toxic substances eating food stuff). iv. We do not have information regarding benefits of alternative providers. g. Commercial impact (no alternative matirial given): The business impact for manufacture (VITLAB) would be -1.500.00 € turnover and five employees. Other manufactures: no information Customers: no information (but noticeable cost increase) | Part_3.docx | https://www.industrydocuments.ucsf.edu/chemical/docs/#id=rlhv0346 | |||||||||||
88 | 3937 | BehalfOfAnOrganisation | 2023/04/27 7:44 | Scope or restriction option analysis | Japan | Company | <redacted> | Yes | There is no suitable alternative material that meets all the required properties. Fluor rubber and fluor resin contribute to automobile safety, contribute to industrial decarbonization, and prevent environmental pollution. Fluor rubber and fluor resin should be excluded because there is no evidence of harm. 6 months is not enough public consultation and 18 months is too short a transition period. Annex XV report (Summary) Proposed restriction - Annex XVII entry PFASs (Restriction Option 2) Column 2 Conditions of restriction 2 There is no instruction specified an internationally accepted method of analysis. It should be specified the PFAS to be targeted for analysis, subject to the existence of an internationally accepted method of analysis. | sectors: E.2.2. uses: ANNEX XV Conditions of restriction 5 e) ANNEX A.3.3.1.1.Use of PFASs in filtration and separation media CAS RN: raw materials 1189053-60-8 423-39-2 75-38-7 116-14-3 132182-92-4 132182-92-4 1189053-50-6 | uses: ANNEX XV Conditions of restriction 5 e) ANNEX A.3.3.1.1.Use of PFASs in filtration and separation media Functions: water and oil repellent, anti-corrosion, HF-resistant coating film. Quantity used: 1-10 t/y Discharge into the environment: no (disposed of as industrial waste or used as a finished product). [Usefulness, benefits] The use of porous filters treated with water and oil repellents offers significant benefits to the social value chain. Fluorinated water and oil repellents (especially fluorotelomer-based) are important application examples due to the unique characteristic origin of fluorine. They are a necessary raw material not only for petrol but also for electric vehicles. [On alternative materials. The evaluation of alternative materials for non-fluorinated water and oil repellents has shown that they cannot fulfil the important performance characteristics derived from the fluorotelomer structure. Currently marketed water and oil repellents for porous filter treatment are time unlimited. [Problems and disadvantages of restricting PFAS Extensive PFAS restrictions (including PFHxA and PFBA restrictions) may have the following consequences. The PFAS regulations are not only a threat to the development of electric vehicles, but also to the development of electric vehicles in general. Significantly reduce the safety and reliability of various components due to much lower performance levels and lifespan. The use of alternative materials will lead to a significant increase in the amount used and an explosive increase in waste. Fluorotelomer, the raw material for fluorinated water and oil repellents, has shown negative results in mutagenicity tests and the proposed restrictions do not immediately apply to handling. [Contents of appeal + p. 11 We request that fluorinated water and oil repellents and fluorotelomer, the raw material for fluorinated water and oil repellents, be exempted from the PFAS regulation as time unlimited uses, recognising that they are widely used in various parts time unlimited for socio-economic activities. | Part_3.docx | ||||||||||
89 | 3938 | BehalfOfAnOrganisation | 2023/04/27 7:50 | Scope or restriction option analysis | Japan | Company | <redacted> | Yes | There is no suitable alternative material that meets all the required properties. Fluor rubber and fluor resin contribute to automobile safety, contribute to industrial decarbonization, and prevent environmental pollution. Fluor rubber and fluor resin should be excluded because there is no evidence of harm. 6 months is not enough public consultation and 18 months is too short a transition period. Annex XV report (Summary) Proposed restriction - Annex XVII entry PFASs (Restriction Option 2) Column 2 Conditions of restriction 2 There is no instruction specified an internationally accepted method of analysis. It should be specified the PFAS to be targeted for analysis, subject to the existence of an internationally accepted method of analysis. | sectors: E.2.2. uses: ANNEX A.3.3. Textiles, upholstery, leather, apparel and carpets CAS RN: raw materials 1189053-60-8 423-39-2 75-38-7 116-14-3 132182-92-4 132182-92-4 1189053-50-6 | Uses: ANNEX A.3.3. textiles, upholstery, leather, apparel and carpets Function: stain protection. Quantity used: < 1 t/y Emissions into the environment: nil (disposed of as industrial waste or used as a finished product). Usefulness, benefits. The use of fluorine-containing textile treatments for time unlimited workers brings significant benefits to the social value chain. Specific benefits include the provision of stain protection and the ability to maintain performance even after several washes. This leads to less frequent washing, significantly less detergent use and longer fabric life, which is environmentally friendly. Fluorinated textile treatments (especially fluorotelomers) are an important application example due to the unique properties of fluorine. They are special materials that are indispensable for time unlimited worker activities. [About alternative materials]. The evaluation of alternative materials for fluorine-containing textile treatments has shown that they do not fulfil the important performance characteristics derived from the fluorotelomer structure. The currently marketed treatments for fluorinated textiles are time unlimited for time unlimited workers. [Problems and disadvantages of restricting PFAS Extensive PFAS restrictions (including PFHxA and PFBA restrictions) may have the following consequences. ▪ The safety of time unlimited workers is threatened due to much lower performance levels and life expectancy. The use of alternative materials will lead to a significant increase in usage and an explosion of waste. The use of alternative materials will lead to a significant increase in the amount of detergents and other materials used, and a significant increase in the amount of cloth waste. Safety assessment of PFASs. The fluorotelomer used as a raw material for the treatment of fluorinated textiles has shown negative results in mutagenicity tests and the proposed restrictions do not immediately apply to handling. [Contents of appeal + p. 11 We request that fluorotelomer, a raw material for fluorine-containing textile treatments, be exempted from the PFAS regulation as an time unlimited use, in recognition of its demand for time unlimited worker activities. | Part_3.docx | ||||||||||
90 | 3939 | BehalfOfAnOrganisation | 2023/04/27 7:54 | Scope or restriction option analysis | Japan | Company | <redacted> | Yes | There is no suitable alternative material that meets all the required properties. Fluor rubber and fluor resin contribute to automobile safety, contribute to industrial decarbonization, and prevent environmental pollution. Fluor rubber and fluor resin should be excluded because there is no evidence of harm. 6 months is not enough public consultation and 18 months is too short a transition period. Annex XV report (Summary) Proposed restriction - Annex XVII entry PFASs (Restriction Option 2) Column 2 Conditions of restriction 2 There is no instruction specified an internationally accepted method of analysis. It should be specified the PFAS to be targeted for analysis, subject to the existence of an internationally accepted method of analysis. | sectors: E.2.11. uses: ANNEX XV Conditions of restriction 5 ee) ANNEX A.3.12. Electronics and semiconductors | Uses: ANNEX XV Conditions of restriction 5 ee) ANNEX A.3.12. Electronics and semiconductors Function: water and oil repellent, anti-corrosion, HF-resistant coatings. Quantity used: 1-10 t/y. Use: 1-10 ton/year [Usefulness, advantages] High heat resistance, high chemical resistance, used in semiconductor manufacturing processes. No alternative materials Chlorine-based and hydrocarbon-based oils are not resistant to the reactive etching gases used in semiconductor manufacturing equipment, and cannot be used due to reactions between the waste etching gas and the vacuum pump oil. Problems and disadvantages of restricting PFASs: As mentioned above, alternative materials react with etching gas, resulting in a significant increase in the risk of vacuum pump damage and fire. Safety assessment of PFASs] As PFASs are inert to highly reactive fluorine gas, they have high chemical stability and are considered to have low carcinogenicity as they are negative in the AMES test. The molecular weight is also large (over 1000), so uptake into living organisms is also considered to be low. The substance is considered to be an time unlimited use lubricant and exempt from the PAFS regulation, considering its beneficial effects in the semiconductor manufacturing process. | Part_3.docx | ||||||||||
91 | 3940 | BehalfOfAnOrganisation | 2023/04/27 8:21 | Scope or restriction option analysis | Japan | Company | <redacted> | Yes | There is no suitable alternative material that meets all the required properties. Fluor rubber and fluor resin contribute to automobile safety, contribute to industrial decarbonization, and prevent environmental pollution. Fluor rubber and fluor resin should be excluded because there is no evidence of harm. 6 months is not enough public consultation and 18 months is too short a transition period. Annex XV report (Summary) Proposed restriction - Annex XVII entry PFASs (Restriction Option 2) Column 2 Conditions of restriction 2 There is no instruction specified an internationally accepted method of analysis. It should be specified the PFAS to be targeted for analysis, subject to the existence of an internationally accepted method of analysis. | sectors: E.2.14. uses: ANNEX XV Conditions of restriction 5 s) ANNEX A.3.15.1.1.Low viscosity lubricants CAS RN: products 60164-51-4 1198429-15-0 1207376-64-4 428-59-1 | Uses: ANNEX XV Conditions of restriction 5 s) ANNEX A.3.15.1.1.Low viscosity lubricants Function: high heat resistance (decomposition temperature > 300°C), high chemical resistance Quantity used: > 100 t/y Environmental emissions: No (disposed of as industrial waste or recovered for reuse). [Usefulness, benefits]. The use of PFPE oil lubricants offers significant benefits to the social value chain. PFPE oil, with its excellent heat and chemical resistance, is an time unlimited lubricant for the semiconductor manufacturing process. The importance of semiconductors as one of the end products goes without saying. Alternative materials. No alternative materials exist. Chlorinated and hydrocarbon-based oils are not resistant to the reactive etching gases used in semiconductor manufacturing equipment and cannot be used because the waste gas, etching gas, reacts with the vacuum pump oil. [Problems and disadvantages of restricting PFAS As mentioned above, alternative materials react with etching gases, significantly increasing the risk of damage to the vacuum pump, risk of fire, etc. Thus, today's socio-economic activities that require semiconductors come to a halt. Safety assessment of PFASs. As they are inert to highly reactive fluorine gas, they have high chemical stability and are considered to have low carcinogenicity as mutagenicity tests are negative. The molecular weight is also large, at more than 1000, so bioaccumulation and uptake in the body are considered low. [Contents of appeal +P11]. Considering its usefulness and importance in the semiconductor manufacturing process, PFPE oil should be considered an time unlimited use as a lubricant and should be exempt from the PAFS regulation. | Part_3.docx | ||||||||||
92 | 3941 | BehalfOfAnOrganisation | 2023/04/27 8:34 | Scope or restriction option analysis | Japan | Company | <redacted> | Yes | sectors: E.2.14. uses: ANNEX XV Conditions of restriction 5 s) ANNEX A.3.15.1.3.Grease | Uses: ANNEX XV Conditions of restriction 5 s) ANNEX A.3.15.1.3.Grease Function: High heat resistance (decomposition temperature > 300°C), high chemical resistance. Quantity used: > 100 t/y Environmental emissions: No (disposed of as industrial waste or recovered for reuse). Usefulness, benefits. The use of PFPE oil as a base oil for greases brings significant benefits to the social value chain. PFPE oil-based greases with excellent heat and chemical resistance are time unlimited for the semiconductor manufacturing process. The importance of semiconductors as one of the end products goes without saying. Alternative materials. No alternative materials exist. If chlorinated or hydrocarbon-based oils are used as base oil, the grease is not resistant to the reactive etching gases used in semiconductor manufacturing equipment, and the grease reacts with the waste gas, etching gas, making it unusable. Problems and disadvantages of restricting PFAS As mentioned above, alternative materials react with etching gases, significantly increasing the risk of equipment damage, fire hazards, etc. Therefore, today's socio-economic activities that require semiconductors come to a halt. Safety assessment of PFASs As they are inert to highly reactive fluorine gas, etc., they have high chemical stability and are considered to have low carcinogenicity as mutagenicity tests are negative. The molecular weight is also large, at more than 1000, so bioaccumulation and uptake in the body are considered low. [Contents of appeal +P11]. Considering the benefit and importance of PFPE oil in the semiconductor manufacturing process, grease with PFPE oil as base oil should be considered as time unlimited use and exempt from the PAFS regulation. | Part_3.docx | |||||||||||
93 | 3942 | BehalfOfAnOrganisation | 2023/04/27 10:25 | Scope or restriction option analysis | Japan | Company | <redacted> | Yes | - We would like to exempt Fluoropolymer, a raw material for hollow fiber filtration membranes used in the production process of food products, from this restriction. - Membrane filtration is economical because it does not require large amounts of waste, techniques, or energy like diatomaceous earth, and it can be used to filter food without compromising its flavor. - To maintain the economic viability of the membranes, long-term physical strength and durability against cleaning chemicals are required, and to our knowledge, fluoropolymer is the only polymer that can meet both requirements. In addition, fluoropolymers have a stable structure and are free of decomposition products during use, making them an essential material for safe food production. - Article 68 of REACH says "evaluation may lead to the conclusion that action should be taken under the restriction or authorisation procedures or that risk management action should be considered in the framework of other appropriate legislation". We believe that only those PFAS that are harmful should proceed with restrictions after appropriate evaluation. | Industrial food and feed production | The percentages of emissions are as follows: - The manufacture phase 0% - The use phase 0% - The end-of-life phase 100% | - When iron is melted by the arc heat of an electric furnace (3000-7000 degrees celsius), fluorinated resin is incinerated at the same time. Residue can be recycled into roadbed material. Fluorine dust is recovered as gas and used for steelmaking materials. (See confidential attachment) - In addition, since our products are used only B to B, the products after use can easily be managed as industrial waste under the policy. | Information on recycling is answered in question 3. | b) - Membrane filtration is economical because it does not require large amounts of waste, techniques, or energy like diatomaceous earth, and it can be used to filter food without compromising its flavor. - To maintain the economic viability of the membranes, long-term physical strength and durability against cleaning chemicals are required, and to our knowledge, fluoropolymer is the only polymer that can meet both requirements. In addition, fluoropolymers have a stable structure and are free of decomposition products during use, making them an essential material for safe food production. - The Fluoropolymer we use is certified by the polymer manufacturer to be free of PFAS and PFOS, which are regulated by the POPs regulation. d) e) - Diatomaceous earth filtration requires calcination prior to use, which is expensive in terms of energy costs, and emits a large amount of CO2 along with it. Because it also impairs the flavor of food, diatomaceous earth is being replaced. - Ceramic membrane filtration requires calcination prior to use, which is expensive in terms of energy costs, and emits a large amount of CO2 along with it. Since the throughput is lower than that of organic membranes, large pumps are required to increase the flow rate, resulting in higher electrical costs. Furthermore, it is not economical because it is prone to root clogging. - Organic membranes are characterized by low energy costs because they do not require sintering and do not impair food flavor, and no technically and economically equivalent alternative methods exist. Furthermore, among the organic films, there are no alternative polymers of fluoropolymer as described in 6.b. (See confidential attachment) f) i, ii There is no technically and economically feasible alternative. f) iii - Diatomaceous earth filtration and ceramic filtration are expensive to operate and manufacture, produce high CO2 emissions, and generate a lot of waste. These methods result in a significant decrease in supply due to lower productivity, leading to higher food production costs and increased CO2 emissions in the EU. - Different filtration methods in the food production process will change the taste and flavor and make it impossible to produce food products. - Using membranes with lower strength increases the frequency of membrane replacement, which reduces food production and raises prices. g) - There is a risk that changes in food production methods will increase production costs and make it impossible to produce foods with the flavors we have come to expect. - Livelihoods of many stakeholders, from farmers of food ingredients to food producers and consumers, will be difficult. Soaring food prices and declining production increase the number of people without access to food and cause social problems. - According to ECHA data, PFAS emissions in food applications are extremely low, less than 1% of total emissions, and have little impact on human health and the environment. It is clear whether this restriction will have a greater impact on society or the environment. | - In the case of facilities that manufacture products that are directly ingested by the human body, such as food, there must be no foreign matter or eluted substances. Fluoropolymer is a stable polymer and its degradation products do not leach into food. It can also be cleaned with chemicals and does not disassemble, keeping it safe. -See attached for information on socioeconomic impacts. | See question 6 and the confidential attachment. | See question 3 for information on recycling | Part_3.docx | ||||
94 | 3943 | BehalfOfAnOrganisation | 2023/04/27 10:33 | Scope or restriction option analysis | Japan | Company | <redacted> | Yes | There is no suitable alternative material that meets all the required properties. Fluor rubber and fluor resin contribute to automobile safety, contribute to industrial decarbonization, and prevent environmental pollution. Fluor rubber and fluor resin should be excluded because there is no evidence of harm. 6 months is not enough public consultation and 18 months is too short a transition period. Annex XV report (Summary) Proposed restriction - Annex XVII entry PFASs (Restriction Option 2) Column 2 Conditions of restriction 2 There is no instruction specified an internationally accepted method of analysis. It should be specified the PFAS to be targeted for analysis, subject to the existence of an internationally accepted method of analysis. | sectors: E.2.14. uses: ANNEX XV Conditions of restriction 5 s) ANNEX A.3.15.1.3.Grease CAS RN: raw materials 252237-40-4 25291-17-2 17527-29-6 1189053-50-6 1219035-32-1 13252-13-6 37382-64-2 51798-33-5 163702-08-7 163702-07-6 163702-06-5 163702-05-4 132182-92-4 428-59-1 116-15-4 116-14-3 75-45-6 7594-51-6 1623-05-8 10493-43-3 2070-70-4 30320-29-7 30320-27-5 30320-26-4 1644-10-6 1998-53-4 2062-98-8 2641-34-1 13252-14-7 26131-32-8 14548-74-4 174080-50-3 27639-98-1 131628-36-9 646029-82-5 646029-84-7 646029-85-8 34761-47-2 133609-46-8 13252-15-8 27617-34-1 51798-33-5 850734-65-5 2416268-96-5 25038-02-2 204270-10-0 | sectors: E.2.14 uses: ANNEX XV Conditions of restriction 5 s) ANNEX A.3.15.1.10.Properties of PFAS-based lubricants and specific properties CAS RN: products 2043-47-2 52591-27-2 1799-84-4 647-42-7 17527-29-6 2144-53-8 125660-00-6 647-42-7 19430-93-4 25291-17-2 80793-18-6 252237-40-4 1189053-50-6 1189053-60-8 1219035-32-1 raw materials 252237-40-4 25291-17-2 17527-29-6 1189053-50-6 1219035-32-1 2062-98-8 13252-13-6 37382-64-2 51798-33-5 163702-08-7 163702-07-6 163702-06-5 163702-05-4 132182-92-4 402-31-3 433-19-2 1189053-60-8 423-39-2 75-38-7 116-14-3 132182-92-4 | Part_3.docx | ||||||||||
95 | 3944 | BehalfOfAnOrganisation | 2023/04/27 10:40 | Scope or restriction option analysis | Japan | Company | <redacted> | Yes | There is no suitable alternative material that meets all the required properties. Fluor rubber and fluor resin contribute to automobile safety, contribute to industrial decarbonization, and prevent environmental pollution. Fluor rubber and fluor resin should be excluded because there is no evidence of harm. 6 months is not enough public consultation and 18 months is too short a transition period. Annex XV report (Summary) Proposed restriction - Annex XVII entry PFASs (Restriction Option 2) Column 2 Conditions of restriction 2 There is no instruction specified an internationally accepted method of analysis. It should be specified the PFAS to be targeted for analysis, subject to the existence of an internationally accepted method of analysis. | sectors: E.2.14 uses: ANNEX XV Conditions of restriction 5 s) ANNEX A.3.15.1.10.Properties of PFAS-based lubricants and specific properties CAS RN: products 2043-47-2 52591-27-2 1799-84-4 647-42-7 17527-29-6 2144-53-8 125660-00-6 647-42-7 19430-93-4 25291-17-2 80793-18-6 252237-40-4 1189053-50-6 1189053-60-8 1219035-32-1 raw materials 252237-40-4 25291-17-2 17527-29-6 1189053-50-6 1219035-32-1 2062-98-8 13252-13-6 37382-64-2 51798-33-5 163702-08-7 163702-07-6 163702-06-5 163702-05-4 132182-92-4 402-31-3 433-19-2 1189053-60-8 423-39-2 75-38-7 116-14-3 132182-92-4 | Uses: ANNEX XV Conditions of restriction 5 s) ANNEX A.3.15.1.10.Properties of PFAS-based lubricants and specific properties Function: adhesion to metal surfaces and imparting of fluorine properties (corrosion protection, stain protection, water and oil repellency). Quantity used: 10-100 t/y. Environmental emissions: No (disposed of as industrial waste). Usefulness, advantages. The use of fluorinated coatings offers significant benefits to the social value chain. Fluorinated coatings (especially fluorotelomer-based) are important application examples due to the unique characteristics of fluorine. They are indispensable industrial materials/sub-materials for electronics, automotive equipment, etc. Fluorine materials are characterised by their high cost, but the fact that they can be used in small quantities to great effect. Fluorochemical technology is considered time unlimited for the global environment, as it allows solutions to be achieved with very small quantities of chemical substances. Alternative materials. It is also important for electronic and semiconductor materials, which are indispensable for the advanced information society expected in the future. Non-fluorine coating agents, especially silicone-based coating agents, cannot be used for these materials due to their electrical properties. In addition, non-fluorinated release agents do not meet performance requirements at all, making the production of many semiconductor components difficult. Evaluation of alternative materials for fluorinated coatings has shown that they cannot fulfil the important performance characteristics derived from the fluorotelomer structure. The fluorinated coatings currently on the market are time unlimited for industrial applications. [Problems and disadvantages of restricting PFAS Extensive PFAS restrictions (including PFHxA and PFBA restrictions) may have the following consequences. Unacceptable worsening of production costs due to the use of alternative materials due to significantly inferior performance levels and service life. The use of alternative materials may lead to a significant increase in the amount of material used, which may have an impact on human health and the environment. Safety assessment of PFASs The fluorotelomer used as a raw material for fluorinated coatings has shown negative results in mutagenicity tests and the proposed restrictions do not immediately apply to its handling. [Contents of appeal + p. 11] With regard to fluorinated coatings and fluorotelomer, the raw material for fluorinated coatings, we request that they be exempted from the PFAS regulation as an time unlimited use in recognition of their importance in electronic and semiconductor materials. | Part_3.docx | ||||||||||
96 | 3945 | BehalfOfAnOrganisation | 2023/04/27 10:46 | Scope or restriction option analysis | Japan | Company | <redacted> | Yes | There is no suitable alternative material that meets all the required properties. Fluor rubber and fluor resin contribute to automobile safety, contribute to industrial decarbonization, and prevent environmental pollution. Fluor rubber and fluor resin should be excluded because there is no evidence of harm. 6 months is not enough public consultation and 18 months is too short a transition period. Annex XV report (Summary) Proposed restriction - Annex XVII entry PFASs (Restriction Option 2) Column 2 Conditions of restriction 2 There is no instruction specified an internationally accepted method of analysis. It should be specified the PFAS to be targeted for analysis, subject to the existence of an internationally accepted method of analysis. | sectors: E.2.1. uses: ANNEX A.2.1. PFASs manufacture - Appendices to Annex A - Appendix A.2. Manufacture, import and uses CAS RN: products 428-59-1 116-15-4 116-14-3 75-45-6 | Uses: ANNEX A.2.1. manufacture of PFASs - Appendix to Annex A - Appendix A.2. manufacture, import and uses Function: to provide high heat resistance, high chemical resistance, water and oil repellency and corrosion protection. Quantity used: 500-1000 t/y. Environmental emissions: no (disposed of as industrial waste or used as a finished product). [Usefulness, benefits] Fluoroethers. They are raw materials that can impart functions to fluorine materials, and the performance of the fluorine materials using these functions can bring significant benefits to the social value chain. Fluoroethers are important raw materials that, due to their perfluoroalkyl groups, can exhibit unique features that cannot be replaced by other materials. The presence of ether groups in between the perfluoroalkyl groups gives them low crystallinity, flexibility and cold resistance. They are indispensable raw materials for the performance of special materials (fluoropolymers, FFKM, FKM and coatings). Numerous public comments on the importance of those special materials can be found in. [On alternative materials. The evaluation of non-fluorinated alternative materials has shown that the production of special materials is technically challenging. They are time unlimited raw materials for the performance of special materials (fluoropolymers, FFKM, FKM, coatings, etc.) that are currently on the market. [Problems and disadvantages of restricting PFAS Extensive PFAS restrictions (including PFHxA and PFBA restrictions) may result in. ▪ Difficulties in manufacturing and maintaining the performance of special materials. The impact on sectors supported by special materials (social infrastructure, semiconductors, automobiles, ships, aerospace, medicine, defence, etc.) will be enormous. The safety of people's lives and the information society will be threatened by the use of alternative materials with significantly inferior performance. (Basically, there are no alternative materials.) Alternative materials with significantly inferior performance lead to an extraordinary increase in the frequency of maintenance, resulting in a serious increase in waste. Safety assessment of PFASs. Fluoroether monomers themselves have shown negative results in mutagenicity tests and the proposed restrictions do not immediately apply to handling. The downstream products using them are not likely to be released into the environment if they are handled using appropriate protective equipment and if their life cycles are properly managed. [Contents of appeal + p.11]. Fluoroethers are low-molecular-weight fluorine compounds that are used as raw materials and are widely used in various fields time unlimited for socio-economic activities, and the monomers themselves are not released into the environment, Basically, like R22, as was the case with the ozone regulation, its intended use as a chemical raw material should be permitted and it should not be subject to PFAS regulation in the first place. The applications that are discharging into the environment should be carefully investigated and regulations should be sought for that part. Perfluoroalkyl materials, including PFOA, are referred to as eternal compounds, but with the development of technology, methods other than combustion have been found to decompose them. Regulations that ignore this will have a negative impact on the future development of science and technology, as well as on the development of mankind. The bioaccumulation potential of low molecular weight fluorinated polyethers themselves has not been confirmed, but it is generally accepted that they do not accumulate above a molecular weight of 1000, so substances with a molecular weight higher than that, like polymers, are of low concern and should not be regulated. | Part_3.docx | ||||||||||
97 | 3946 | BehalfOfAnOrganisation | 2023/04/27 10:54 | Scope or restriction option analysis | Japan | Company | <redacted> | Yes | There is no suitable alternative material that meets all the required properties. Fluor rubber and fluor resin contribute to automobile safety, contribute to industrial decarbonization, and prevent environmental pollution. Fluor rubber and fluor resin should be excluded because there is no evidence of harm. 6 months is not enough public consultation and 18 months is too short a transition period. Annex XV report (Summary) Proposed restriction - Annex XVII entry PFASs (Restriction Option 2) Column 2 Conditions of restriction 2 There is no instruction specified an internationally accepted method of analysis. It should be specified the PFAS to be targeted for analysis, subject to the existence of an internationally accepted method of analysis. | sectors: E.2.1. uses: ANNEX XV Conditions of restriction 5 a) ANNEX A.2.1.5.1.Polymerisation aid CAS RN: raw materials 252237-40-4 25291-17-2 17527-29-6 1189053-50-6 1219035-32-1 13252-13-6 37382-64-2 51798-33-5 163702-08-7 163702-07-6 163702-06-5 163702-05-4 132182-92-4 428-59-1 116-15-4 116-14-3 75-45-6 7594-51-6 1623-05-8 10493-43-3 30320-29-7 30320-27-5 30320-26-4 1644-10-6 1998-53-4 2062-98-8 2641-34-1 13252-14-7 26131-32-8 14548-74-4 174080-50-3 27639-98-1 131628-36-9 646029-82-5 646029-84-7 646029-85-8 34761-47-2 133609-46-8 13252-15-8 27617-34-1 51798-33-5 850734-65-5 2416268-96-5 25038-02-2 204270-10-0 85737-06-0 120903-40-4 283593-02-2 178200-05-0 1187-93-5 2070-70-4 1584-03-8 124709-43-9 360-53-2 37881-252237-40-4 25291-17-2 17527-29-6 1189053-50-6 1219035-32-1 13252-13-6 37382-64-2 51798-33-5 163702-08-7 163702-07-6 163702-06-5 163702-05-4 132182-92-4 428-59-1 116-15-4 116-14-3 75-45-6 7594-51-6 1623-05-8 10493-43-3 30320-29-7 30320-27-5 30320-26-4 1644-10-6 1998-53-4 2062-98-8 2641-34-1 13252-14-7 26131-32-8 14548-74-4 174080-50-3 27639-98-1 131628-36-9 646029-82-5 646029-84-7 646029-85-8 34761-47-2 133609-46-8 13252-15-8 27617-34-1 51798-33-5 850734-65-5 2416268-96-5 25038-02-2 204270-10-0 85737-06-0 120903-40-4 283593-02-2 178200-05-0 1187-93-5 2070-70-4 1584-03-8 124709-43-9 360-53-2 37881-62-2 376-53-4 3107-98-0 13140-21-1 | Uses: ANNEX XV Conditions of restriction 5 a) ANNEX A.2.1.5.1.Polymerisation aid Function: surfactant Amount used: 10-100 t/y Discharge into the environment: No (disposed of as industrial waste). Usefulness, benefits. The use of surfactants brings significant benefits to the social value chain. Fluorinated surfactants are an important example of applications derived from the unique characteristics of fluorine. They are indispensable raw materials for the production of special materials (fluoropolymers, FFKM, FKM, etc.). See numerous public comments on the importance of those special materials. If restrictions are to be set, the toxicity, etc. based on scientific findings should be clearly stated and emission standards should be set, without which restrictions are wildly logical. Surfactants in products are also incorporated into the product itself and should be judged with the product's life cycle. (If the product is treated by combustion, there is no release into the environment.) [On alternative materials]. The evaluation of alternative materials for non-fluorinated surfactants showed that it is technically difficult to manufacture special materials. Fluorinated surfactants currently on the market are time unlimited for the manufacture of special materials (fluoropolymers, FFKM, FKM, etc.). [Problems and disadvantages of restricting PFAS Extensive PFAS restrictions (including PFHxA and PFBA restrictions) may have the following consequences. ▪ It will be difficult to manufacture special materials. The impact on sectors supported by special materials (social infrastructure, semiconductors, automobiles, ships, aerospace, medicine, defence, etc.) will be enormous. The safety of people's lives and the information society will be threatened by the use of alternative materials with significantly inferior performance. The use of alternative materials with significantly inferior performance leads to an extraordinary increase in the frequency of maintenance and, consequently, a serious increase in waste. Safety assessment of PFASs. Fluorosurfactants and their raw materials, low-molecular-weight fluorine compounds, have shown negative results in mutagenicity tests and are not immediately subject to the proposed restrictions in handling. [Contents of appeal + p11 With regard to fluorosurfactants and low-molecular-weight fluorine compounds that are their raw materials, we request that they be exempted from the PFAS regulation as time unlimited uses, recognising that they are widely used in various fields time unlimited for socio-economic activities. | Part_3.docx | ||||||||||
98 | 3947 | BehalfOfAnOrganisation | 2023/04/27 11:14 | Scope or restriction option analysis | Japan | Company | Taiyo Manufacturing Co., Ltd. | While we understand the concern regarding the so called 'forever chemicals', we would consider positive to determine which chemicals included in PFAS are considered substances of high concern. We are a manufacturer of plastic plated products and a small amount of our processes have chemicals with PFAS, such as mist suppressants for chromic acid etching processes and preliminary surface treatment. Trials were performed in the past using PFAS free chemicals for preliminary surface treatment and their performance was not up to par. As for chromic acid etching, at the moment there is not a single PFAS free mist suppressant in the market. Without the necessary chemicals, our defect rates would increase noticeably, thus causing an considerable economic impact in our company and other enterprises in the same industry. It has to be considered too that defective products can be recycled at a certain extent. However, non-recyclable materials are a burden to the environment. Producing massive amounts of waste in order to get rid of a minimum amount of chemicals is not likely to solve the environmental issue but to worsen it. It is for the previously stated reasons that we would request a thorough description of those chemicals in PFAS whose usage should be restricted and not to apply the restriction generally until there are feasible solutions. We agree progress and a better environment are for the better but not at just any cost. | Part_3.docx | |||||||||||||
99 | 3949 | BehalfOfAnOrganisation | 2023/04/27 12:22 | Scope or restriction option analysis | Japan | Company | <redacted> | Yes | ・Ion exchange membranes containing perfluorosulphonic acid polymers, perfluorocarboxylic acid polymers and PTFE reinforcing core material used in the electrolysis process of alkali chloride electrolysis should be excluded from this restriction. ・The ion-exchange membrane method is an excellent production method with higher energy efficiency and lower environmental impact than other diaphragm and mercury methods. In addition, caustic soda and chlorine produced by the ion-exchange membrane method play an important role as basic raw materials in various industries and are indispensable chemical products in people's lives. ・Ion exchange membranes are exposed to chlorine, 32% NaOH, hypochlorous acid, and hydrochloric acid at temperatures close to 90°C.No materials are known to be resistant to these substances, with the exception of fluoropolymers. | a ・Emissions are 0% during the manufacture and the use phase. ・Emissions are 100% at the end of life phase. | ・When iron is melted by the arc heat of an electric furnace (3000-7000°C), fluorinated resin is incinerated at the same time. Residue can be recycled into roadbed material. Fluorine dust is recovered as gas and used for steelmaking materials. | a ・Approximate amount of PFAS used in alkaline chloride electrolysis applications : approx. 30-35 tonnes/year ・Type：Chemical industry b ・Chemical resistance, ・Mechanical strength c ・Number of Ion-exchange membrane method of alkali chloride electrolysis in EU: 40 companies, 59 factories d ・Ion exchange membranes are exposed to chlorine, 32% NaOH, hypochlorous acid, and hydrochloric acid at temperatures close to 90°C. No materials are known to be resistant to these substances, with the exception of fluoropolymers. e ・As far as the patent literature is searched, no information on consideration of alternatives has been found. f ⅲ ・No material with equivalent performance currently exists. ・Alkali chloride electrolysis methods include the ion-exchange membrane method, the mercury method, which uses toxic mercury, and the diaphragm method, which uses asbestos. ・The ion-exchange membrane method is an excellent production method with higher energy efficiency and lower environmental impact than other diaphragm and mercury methods. g ・In the EU, 84.5% of chlorine and caustic soda is produced using ion exchange membrane processes, and if fluorinated resins are no longer available due to PFAS regulations, the majority of chlorine and caustic soda in Europe will not be supplied. ・Caustic soda is an essential substance in people's lives, as it is used in the production of various chemicals as intermediate raw materials and in the manufacture of various industrial and daily end products. ・Chlorine is used in the manufacture of vinyl chloride resin, urethane resin, epoxy resin, synthetic rubber and various solvents. It is also used in the sterilisation of tap water and in the manufacture of pharmaceuticals, making it an indispensable substance in our daily lives. | ・Efficient fluoride recovery from poly(vinylidene fluoride), poly(vinylidene fluoride-co-hexafluoropropylene) copolymer and poly(ethylene-co-tetrafluoroethylene) copolymer using superheated water with alkaline reagent. https://www.sciencedirect.com/science/article/pii/S0014305722007285 | Part_3.docx | ||||||||
100 | 3950 | Individual | 2023/04/27 12:31 | Information on alternatives | | | Manufacturing and using of machinery | Part_3.docx |