Document jnmLROqQ82yLxLOpao7v710N

PUBLIC CONSULTATION | SUBMITTED ON 30.05.2023 Berghof Membrane Technology Section III - General and specific information Summary We decided to submit a non-confidential and confidential report (attachments section IV an section V) to elaborate in detail on all the important topics addressed in the ECHA public consultation request. It is recommended to ECHA examiners to evaluate the confidential report, since more detailed and business related data could be provided. A summary is given below, but note that all detailed information with supporting references and data is presented in the attachments! Scope or restriction option analysis: The submission of Berghof Membrane Technology relates to industrial filter and membrane filtration in the water treatment sector. This sector and application is not included in the Annex XV restriction report. The total market for membranes for water treatment comprises 1.846 Mio $ (status April 2023). Membranes, made from polymeric material play a significant role in this sector (93%!). A considerable quantity of polymeric membranes consist of fluoropolymers and polyvinylidene difluoride (PVDF) in particular. The fluoropolymer used in our products is PVDF. PVDF exhibits high mechanical strength, good chemical resistance and thermal stability as well as excellent aging resistance, which are very important for the actual application of separation membranes. Our membranes are mainly applied in Membrane Bioreactors (MBR). Nearly, 60% of all membranes used in MBR technology is based on PVDF. Hazard or exposure: PVDF is a polymer of low concern (PLC) in terms of its potential environmental and human health impacts. To this, it is important that PVDF is manufactured without the use of PFAS-of-concern. PVDF is not classified as a hazardous substance by major regulatory bodies such as the European Chemicals Agency (ECHA) or the U.S. Environmental Protection Agency (EPA). Environmental emissions: Production waste cannot be recycled or reused, and must be incinerated. It is shown in scientific studies that municipal incineration of fluoropolymers using best available technologies is not a significant source of PFAS and should be considered an acceptable form of waste treatment. Furthermore, it is shown that no other emission-based PFAS are discharged from the manufacturing process. The relation between PVDF and its global impact as microplastic (MP) in marine environment was investigated and it was concluded that PVDF plays a minor role when it concerns microplastics. PVDF has a high molecular weight, little to no water solubility and volatility, therefore they are not expected to degrade to low- er molecular weight PFAS. Additionally, it was shown that membrane filtration delivers a substantial contribution to applications related to recycling, zero liquid discharge and circular economy. Information on alternatives: The only technical and commercial relevant alternative to PVDF-based membranes in water treatment are PES-based membranes. The general properties of both materials related to its application differ in case of processing, fouling tendency, chemical stability (superior oxidative stability), mechanical behavior (i.e. flexibility), membrane morphology (i.e. pore size and porosity). Based on more than 2000 references worldwide, it can be stated that the lifetime of PVDF membranes ranges between 7-10 years and the lifetime of PES membranes ranges between 2-5 years. PUBLIC CONSULTATION | SUBMITTED ON 30.05.2023 S. 2/20 There is simply no `one shoe fits all' in membrane technology. In some sectors/applications PVDF clearly outperforms PES, e.g. water treatment by MBR technology, in other sectors/applications PES is advantageous. Crucial for running the membrane systems is the membrane performance, energy consumption, maintenance, chemical cleanings and membrane lifetime (module replacement, waste generation) and therefore it is necessary to choose the best material for the application. Information on benefits: We do not see any benefits related to the ban of fluoropolymers in general and PVDF in particular. On the other hand, we see the benefits of using PVDF as membrane materials. This is shown exemplarily by means of two business cases: i. anaerobic MBR application; ii. zero liquid discharge application. Other socio economic analysis (SEA) issues: As soon the restriction takes effect, it is expected that Berghof Membrane Technology will lose significant share of the business outside Europe, mainly in China and the USA due to direct local Chinese resp. American competition, because we cannot meet the customer demands and we cannot offer competitive products. The European market has to switch from PVDF to PES based tubular membrane modules. The main global manufacturers of tubular membranes are located in Europe and a strong competition for a relatively small market will occur. Because of these uncertainties, Berghof Membrane Technology is probably forced to reduce capacities in a similar proportion as the loss of market share and it is very doubtful if Berghof Membrane Technology can continue its tubular membrane business at all. As an alternative, the production of Berghof Membrane Technology has to be transferred to outside of Europe resulting in losses of i. jobs, ii. taxes and iii technical/production knowhow. This does not have an impact solely on Berghof Membrane Technology but on whole Berghof Company as well, since Berghof Membrane Technology is a significant pilar for the Berghof Company, which existence is highly endangered when tubular PVDF membrane modules cannot be manufactured anymore (in Europe). Request for exemption: Berghof Membrane Technology cannot comprehend the possible ban of fluoropolymers in general and PVDF in particular. We are not against a restriction/limitation of hazardous PFAS-of-concern, and support a scientific approach differentiating high and low risk substances based on risk assessment. In that way, it should be concluded that fluoropolymers should not be treated in a similar way as other PFAS substances and should be taken out the ECHA restriction dossier. Fluoropolymers should be exempted from any regulatory action under the REACH restriction!! Berghof Membrane Technology GmbH | Arbachtalstrae 26 | 72800 Eningen | www.berghofmembranes.com 2023-05-30_Public Consultation_Berghof Membranes PUBLIC CONSULTATION | SUBMITTED ON 30.05.2023 S. 3/20 Contents 1. 1.1. 1.2. 1.3. 1.4. 1.5. 1.6. 1.7. 1.8. 1.9. 1.10. General information ............................................................................................................................. 4 Scope or restriction option analysis .........................................................................................................................................4 Hazard or exposure ...................................................................................................................................................................8 Environmental emissions ........................................................................................................................................................10 Baseline ..................................................................................................................................................................................... 11 Description of analytical methods ..........................................................................................................................................11 Information on alternatives......................................................................................................................................................12 Information on benefits ............................................................................................................................................................15 Other socio economic analysis (SEA) issues.......................................................................................................................16 Transitional period....................................................................................................................................................................17 Request for exemption ............................................................................................................................................................17 2. 2.1. 2.2. 2.3. 2.4. 2.5. 2.6. 2.7. 2.8. 2.9. 2.10. Specific Information ........................................................................................................................... 18 Sectors and (sub-)uses ...........................................................................................................................................................18 Emissions in the end-of-life phase .........................................................................................................................................18 Emissions in the end-of-life phase .........................................................................................................................................18 Impacts on the recycling industry...........................................................................................................................................18 Proposed derogations - Tonnage and emissions ...............................................................................................................18 Missing uses - Analysis of alternatives and socio-economic analysis .............................................................................19 Potential derogations marked for reconsideration - Analysis of alternatives and socio-economic analysis ...............20 Other identified uses - Analysis of alternatives and socio-economic analysis................................................................20 Degradation potential of specific PFAS sub-groups............................................................................................................20 Analytical methods ...................................................................................................................................................................20 Berghof Membrane Technology GmbH | Arbachtalstrae 26 | 72800 Eningen | www.berghofmembranes.com 2023-05-30_Public Consultation_Berghof Membranes PUBLIC CONSULTATION | SUBMITTED ON 30.05.2023 1. General information S. 4/20 1.1. Scope or restriction option analysis PFAS type: Main application/Sector: Sub-use: Fluoropolymer: polyvinylidene difluoride (PVDF) (homo- and copolymer) (Note: in our public consultation reply, PVDF is defined as PVDF homo- and PVDF copolymer as a whole) Water treatment* industrial filter / membrane filtration Sector**: E: WATER SUPPLY; SEWERAGE, WASTE MANAGEMENT AND REMEDIATION ACTIVITIES 36: Water collection, treatment and supply - treatment of water for industrial and other purposes General Industries: Dairy, Food & Beverage, Chemical & Pharma, Textile & Tannery, Petrochemical, Landfill leachate, Mining & metals, Automotive Applications: Membrane bioreactors (aerobic and anaerobic) Industrial wastewater treatment Recycling of process water Direct filtration of process streams Zero Liquid Discharge Industrial food & feed processing Membrane processes: Microfiltration (MF), ultrafiltration (UF), membrane contactor, membrane distillation (MD) Membrane geometry: Hollow fiber, capillary - self-supporting tubes with inner tubes diameter < 3 mm Tubular - nonwoven supported tubes with inner tubes diameter > 3 mm Flat sheet - nonwoven supported sheets Module configuration: Capillary membrane module Tubular membrane module Spiral wound module Plate-frame module Membrane market for water treatment Membranes for water treatment are not addressed in the Annex XV restriction report. In the following figure and table, market share and numbers are presented regarding membranes for water treatment, segmented to i. region; ii) application and iii) product type [GWI 2023]. It has to be noted, that these number are `just' related to membranes. Installations, electronics, sensorics, controls, amongst many others, are not included!! The total market for membranes for water treatment comprises 1.846 Mio $ (status April 2023). Membranes, made from polymeric material play a significant role in this sector (93%!). A considerable quantity of polymeric membranes consist of fluoropolymers (PVDF in particular). The share of PVDF membranes is addressed in `PVDF for membranes'. The significance of membranes for water treatment has to be noticed and acknowledged to judge the relevance of fluoropolymer membranes!! Berghof Membrane Technology GmbH | Arbachtalstrae 26 | 72800 Eningen | www.berghofmembranes.com 2023-05-30_Public Consultation_Berghof Membranes PUBLIC CONSULTATION | SUBMITTED ON 30.05.2023 Table 1: Membrane market analysis for water treatment, segmented to i. region; ii) application and iii) product type; status April 2023 Segmentation Category Value (Mio $) Total market 1846 Region East Asia / Pacific Europe / Central Asia Latin America / Caribbean Middle East / Africa North America Southern Asia 1358 188 35 67 162 36 Application Process/drinking water treatment Seawater and brackish water desalination Ultrapure water treatment Wastewater treatment 228 59 84 1475 Product type Polymeric membranes Ceramic membranes 1715 131 S. 5/20 Figure 1: Membrane market analysis for water treatment, segmented to i. region; ii) application and iii) product type; status April 2023 PVDF PVDF is a Polymer of Low Concern (PLC) the study by Korzeniowski et al. [Korzeniowski 2023] has presented data demonstrating that the investigated fluoropolymers (PVDF amongst others) satisfy the widely accepted polymer hazard assessment criteria and that these polymers are to be considered PLC [OECD 2009]. Berghof Membrane Technology GmbH | Arbachtalstrae 26 | 72800 Eningen | www.berghofmembranes.com 2023-05-30_Public Consultation_Berghof Membranes PUBLIC CONSULTATION | SUBMITTED ON 30.05.2023 S. 6/20 PVDF for membranes PVDF is a semicrystalline polymer with repeated unit of -(CH2CF2)n-. It exhibits high mechanical strength, good chemical resistance and thermal stability as well as excellent aging resistance, which are very important for the actual application of separation membranes. Moreover, PVDF shows good processability to prepare flat sheet, hollow fiber or tubular membranes [Lui 2011] [Kang 2014]. The relevance of PVDF-based membranes for membrane bioreactors (MBR) was shown by Prof. Simon Judd on his MBRsite-Website [Judd 2017]. He evaluated the MBR market intensively and he showed that nearly 60% of all applied membranes, with different configurations, in MBR is PVDF-based (see Figure 2). This indicates the commercial relevance of PVDF membranes in this market. Figure 2: Distribution of membrane materials between the three membrane configurations applied in MBR: flat sheet (FS), hollow fibre (HF) and multitube (MT) [Judd 2017] The American Membrane Technology Association (AMTA) provided a very relevant and to-the-point position paper expressing their doubts and worries when PVDF for PVDF membranes is classified as PFAS [AMTA 2023]. Berghof Membrane Technology completely supports the statements on PVDF and PFAS as elaborated in the position paper. The position of AMTA is as follows: The scientific relevance can be demonstrated by means of yearly amount of publications on `PVDF membrane' by Dimensions [Dimensions 2023]: Berghof Membrane Technology GmbH | Arbachtalstrae 26 | 72800 Eningen | www.berghofmembranes.com 2023-05-30_Public Consultation_Berghof Membranes PUBLIC CONSULTATION | SUBMITTED ON 30.05.2023 S. 7/20 Figure 3: Yearly amount of publications on `PVDF membrane' by Dimensions [Dimensions 2023] Tubular UF membrane module products at Berghof Membrane Technology Tubular ultrafiltration membrane modules consists of tubular membranes mounted in a housing in order to separate the feed/concentrate side from the filtrate side. Some Berghof modules are presented in the figure below. Tubular membranes are nonwoven support tubes with a PVDF coating on the inside of the tube (Figure 4). More information about the company and the products can be found on the website: www.berghofmembranes.com. Figure 4: Tubular ultrafiltration membrane modules; left: presentation of selected filtration modules; middle: tubular membranes; right: cross section of a tubular membrane made by scanning electron microscopy. Tubular UF membrane modules containing PVDF Supply chain PVDF supply: Detailed information from the supplier of PVDF is given in the `confidential document'. PVDF membrane manufacturing: PVDF membranes are formed by means of the non-solvent induced phase separation. To this, the PVDF is solved in a solvent resulting in a polymer solution. In the tubular membrane apparatus, nonwoven tubes are formed and subsequently, the polymer solution is cast on the inside of the tube. The coated tube is conveyed into a non-solvent precipitation bath. Here, the actual phase separation takes place where the PVDF solidifies on the inside of the tube to form porous mem- brane layer. After several after-treatment steps, including drying, the PVDF-coated UF tubular membrane is produced. The tubular membranes can be further processed in the module manu- facturing, where the membrane modules are produced. Berghof Membrane Technology GmbH | Arbachtalstrae 26 | 72800 Eningen | www.berghofmembranes.com 2023-05-30_Public Consultation_Berghof Membranes PUBLIC CONSULTATION | SUBMITTED ON 30.05.2023 S. 8/20 Product: Downstream users: Tubular UF membrane modules 1. Direct customers are original equipment manufacturers (OEMs), 2. System integrators / plant builders 3. Endusers * Water treatment is not mentioned as `main application' in the Annex XV restriction report (table 2 and table 9). ** Sector is defined according to Eurostat Reference And Management Of Nomenclatures (RAMON) - Statistical Classification of Economic Activities in the European Community (NACE), Rev. 2 (2008), (https://ec.europa.eu/eurostat/ramon/index.cfm?TargetUrl=DSP_PUB_WELC) References [GWI 2023] GWI water database, last update April 2023. [Korzeniowski 2023] Korzeniowski et al., a critical review of the application of polymer of low concern regulatory criteria to fluoropolymers II: Fluoroplastics and fluoroelastomers, Integr. Environ. Assess. Manag. 19(2), 2023, 326-354 (https://doi.org/10.1002/ieam.4646) [OECD 2009] Organization for Economic Co-operation and Development (OECD), Task Force on New Chemicals Notification and Assessment, Data analysis of the identification of correlations between polymer characteristics and potential for health or ecotoxicological concern, 2009 (https://www.oecd.org/env/ehs/risk-assessment/42081261.pdf) [Kang 2014] Kang et al., application and modification of poly(vinylidene fluoride) (PVDF) membranes - A review, J. Membr. Sci., 463, 2014, 145-165 (https://doi.org/10.1016/j.memsci.2014.03.055) - due to copyright, attached in confidential section [Lui 2011] Lui et al., progress in the production and modification of PVDF membranes, J. Membr. Sci., 375(1-2), 2011, 1-27 (https://doi.org/10.1016/j.memsci.2011.03.014) - due to copyright, attached in confidential section [Judd 2017] S. Judd, `the MBR site' website, the material question - choosing MBR membrane materials, https://www.thembrsite.com/blog/choosing-mbr-membrane-materials/, visited on 20.04.2023 [AMTA 2023] American Membrane Technology Association (AMTA), position paper: Broad Definitions of PFAS may Classify PVDF Membranes as PFAS compounds, https://www.amtaorg.com/wp-content/uploads/AMTA-Fact-Sheet-32-PVDF-Position-Rev0.pdf, visited on 30.05.2023 [Dimensions 2023] Dimensions website, https://app.dimensions.ai, visited on 05.04.2023 Confidential attachments: Confirmation of fluorosurfactant-free manufacturing of PVDF - provided by the PVDF supplier 1.2. Hazard or exposure PVDF (Polyvinylidene fluoride) is generally considered to be a polymer of low concern (PLC) in terms of its potential environmental and human health impacts. It is not considered to be a carcinogen, mutagen, or reproductive toxin. Additionally, PVDF is resistant to biodegradation and does not contribute significantly to environmental pollution. [Korzeniowski 2023] PVDF is not classified as a hazardous substance by major regulatory bodies such as the European Chemicals Agency (ECHA) or the U.S. Environmental Protection Agency (EPA). The European Chemicals Agency (ECHA) has assessed PVDF and concluded that it does not meet the criteria for classification as a hazardous substance under the Classification, Labelling and Packaging (CLP) Regulation (EC) No. 1272/2008 [ECHA 2021]. The US Environmental Protection Agency (EPA) has classified PVDF as a polymer exempt from premanufacture notification (PMN) requirements under the Toxic Substances Control Act (TSCA) [EPA 2023]. PVDF is flagged with XU, which indicates a substance exempt from reporting under the Chemical Data Reporting Rule, (40 CFR 711). This means that PVDF is not considered to pose an unreasonable risk to human health or the environment. However, it is important to note that the environmental and human health impacts of PVDF can vary depending on the specific application and the manufacturing process used. As with any material, proper handling, use, and disposal are important to minimize potential risks. Berghof Membrane Technology GmbH | Arbachtalstrae 26 | 72800 Eningen | www.berghofmembranes.com 2023-05-30_Public Consultation_Berghof Membranes PUBLIC CONSULTATION | SUBMITTED ON 30.05.2023 S. 9/20 Two other information sources can be given related to hazard and exposure, i.e.: safety data sheet; the safety data sheet of PVDF does not include any hazard statements or precautionary statements. The safety data sheet from the PVDF supplier is given in the `confidential document'. Food Contact Status; since PVDF is Food Contact Material (FCM), it can be concluded that hazard and exposure play an inferior role. The compliancy statement from the PVDF supplier is given in the `confidential document'. Substance of Very High Concern (SVHC) declaration, the applied PVDF is not Substance of Very High Concern and do not contain any SVHC substance(s) above the declaration threshold. The declaration from the PVDF supplier is given in the `confidential document'. Restriction of Hazardous Substances (RoHS) declaration, based on a review of the applied PVDF final product composition, there are no RoHS substances known to be present above the reporting threshold in above mentioned products. The declaration from the PVDF supplier is given in the `confidential document'. It should be noted, that the used PVDF is manufactured without using PFAS-of-concern. This is already confirmed in the first section. So, the argument of hazard or exposure related to manufacturing aids does not apply here! Finally, we want to emphasize that Article 68 (1) of REACH (Introducing new and amending current restrictions) phrases that there must be an unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market of substances [REACH 2023]. It is shown in this section, that this is not the case! References [Korzeniowski 2023] Korzeniowski et al., a critical review of the application of polymer of low concern regulatory criteria to fluoropolymers II: Fluoroplastics and fluoroelastomers, Integr. Environ. Assess. Manag. 19(2), 2023, 326-354 (https://doi.org/10.1002/ieam.4646) [ECHA 2021] ECHA, Substance Infocard (last updated: 21.12.2021), Ethene, 1,1-difluoro-, homopolymer, CAS no. 24937-79-9, https://echa.europa.eu/de/substance-information/-/substanceinfo/100.133.181, visited on 12.04.2023 [EPA 2023] EPA, TSCA Chemical Substance Inventory. Database last created: 02/2023, ID:22570 CAS no. 24937-79-9, https://www.epa.gov/tsca-inventory/how-access-tsca-inventory, visited on 13.04.2023 [REACH 2023] REACH online, https://reachonline.eu/reach/en/title-viii-chapter-2-article-68.html, visited on 05.05.2023 Confidential attachments: Safety Data Sheet - provided by the PVDF supplier Food Contact Status - provided by the PVDF supplier Substance of Very High Concern (SVHC) declaration - provided by the PVDF supplier Restriction of Hazardous Substances (RoHS) declaration - provided by the PVDF supplier Berghof Membrane Technology GmbH | Arbachtalstrae 26 | 72800 Eningen | www.berghofmembranes.com 2023-05-30_Public Consultation_Berghof Membranes PUBLIC CONSULTATION | SUBMITTED ON 30.05.2023 1.3. Environmental emissions S. 10/20 Emissions during manufacturing The membrane module fabrication allows two emission possibilities for fluoropolymers/PFAS: 1. Membrane drying - membranes are dried in an oven. From the oven there is exhaust air into the environment. 2. Process wastewater - the emitted process water is discharged into the sewerage. Membrane drying Membranes are prepared by the phase inversion process where the membranes are immersed in water. In the membrane module manufacturing process, it is necessary to process dried membranes. Before drying, the membranes are conditioned to avoid pore collapse during the drying process. Membranes are dried in an oven. The exhaust is conducted through a condenser. The condensate fraction is disposed in our process waste water. Process wastewater Water samples of process water to be discharged into the sewerage were taken. The samples were analysed by Eurofins (accredited DIN EN ISO/IEC 17025:2018 - DAkkS D-PL-14078-01-00) and all investigated PFAS, according to standardized protocols, were below limits of quantification. The results and laboratory report are presented in the `confidential document'. It can be concluded that no PFAS leaves our manufacturing by waste water discharge! Production waste, reuse and recycling Production waste is not included in the definition of emission as defined by German law [BImSchG 2022]. Since waste management is a very important part of the whole production process, numbers regarding waste, reuse and recycling in the period 2019-2021 are given in the confidential report. The numbers show an increase in production quantity of PVDF and, in addition, the scrap rate is reduced due to continuous improvement. Waste treatment - reuse, recycling or incineration PVDF is present as a thin membrane layer on a nonwoven tube. The attachment of PVDF to the nonwoven is extremely good resulting in high quality products for filtration. This means that PVDF scrap in the form of membranes cannot be reused or recycled and has to be incinerated. Incineration The thermal degradation of fluoropolymers, and PTFE in particular, by incineration was investigated thoroughly and summarized by Sales [Sales 2022]. For PTFE, it was concluded that complete thermal decomposition is achieved at a temperature of about 800C. Concerning incineration, data can be referred to PTFE (which is more intensively studied), because this fluoropolymer is thermally more stable than PVDF (i.e. worst case approach). In more detail, incineration was studied by Aleksandrov et al. [Aleksandrov 2019]. The conclusion was no significant evidence could be found of PFAS creation (of the 31 studied PFAS species) during the incineration of PTFE. Therefore, it can be expected that municipal incineration of PTFE (and therefore also PVDF) using best available technologies (BAT) is not a significant source of studied PFAS and should be considered an acceptable form of waste treatment. Degradation to Microplastics The relation between PVDF and its global impact as microplastic (MP) in marine environment was investigated by means of the risk screening method [Yuan 2022]. 36 different polymers were evaluated on global level by five different risk factors covering the probability of human exposure to MP and the potential impact. PVDF was ranked 36/36 with a risk score of 22! This, in comparison to e.g. polyurethane (PUR), ranked 1/36, with a risk score of 150. In conclusion, PVDF plays a minor role when it concerns microplastics. Degradation to PFAS-of-Concern Finally, fluoropolymers are substantially different from the other polymeric PFAS in terms of potential emissions due to degradation into small PFAS molecules during intended use or under environmental conditions and, for this reason, they have no environmental impact. Fluoropolymers have a high molecular weight, little to no water solubility and volatility, therefore they are not expected to degrade to low- er molecular weight PFAS. Also, they are not expected to lead to the formation of long-chain PFAS as a result of degradation. [Sales 2022] Berghof Membrane Technology GmbH | Arbachtalstrae 26 | 72800 Eningen | www.berghofmembranes.com 2023-05-30_Public Consultation_Berghof Membranes PUBLIC CONSULTATION | SUBMITTED ON 30.05.2023 S. 11/20 PVDF membranes contribution to PFAS emission and water treatment in general Membrane technology contributes to isolation and concentration of PFAS. This is extensively described by Das et al. [Das 2022]. Tubular membranes are applied in water treatment and industrial wastewater treatment in particular. Most PFAS-of-concern are short-chained substances which cannot directly by treated by ultrafiltration, but ultrafiltration is necessary as a pretreatment for Nanofiltration or Reverse Osmosis in order to technological and economical feasible operation. With the annual produced filter area at Berghof Membrane Technology, it was calculated that, with continuous operation without taking cleaning and system downtime into account, approx. 100.000.000 m of water can be treated annually. Details for this calculation are given in the `confidential document'. Fluorosurfactant-free manufacturing It should be noted, that the used PVDF is manufactured without using PFAS-of-concern. This is already confirmed in the first section. So, the argument of environmental emissions related to manufacturing aids does not apply here! References [BImSchG 2022] Bundesministerium der Justiz, Gesetz zum Schutz vor schdlichen Umwelteinwirkungen durch Luftverunreinigungen, Gerusche, Erschtterungen und hnliche Vorgnge (Bundes-Immissionsschutzgesetz - BImSchG), last revision in 2022, https://www.gesetze-im-internet.de/bimschg/, visited on 26.04.2023 [Aleksandrov 2019] Aleksandrov et al., Waste incineration of Polytetrafluoroethylene (PTFE) to evaluate potential formation of per- and PolyFluorinated Alkyl Substances (PFAS) in flue gas, Chemosphere 226, 2019, 898-906 (https://doi.org/10.1016/j.chemosphere.2019.03.191) [Yuan 2022] Yuan et al., Ranking of potential hazards from microplastics polymers in the marine environment, J. Hazard. Mater. 429, 2022, 1-19 (https://doi.org/10.1016/j.jhazmat.2022.128399) [Sales 2022] Sales et al., Fluoropolymers: The Safe Science That Society Needs, International Chemical Regulatory and Law Review (ICRL) 5(1), 2022, 13-23 (https://icrl.lexxion.eu/data/article/18600/pdf/icrl_2022_01_2022-11-02-12.39.059.pdf) [Das 2022] Das et al., A Review on Removal and Destruction of Per- and Polyfluoroalkyl Substances (PFAS) by Novel Membranes, Membranes 12(7), 2022, 662. (https://doi.org/10.3390/membranes12070662) (not attached due to large document size and the 20 MB upload availability) Confidential attachments: Measurements of process water - attached to confidential document 1.4. Baseline Since water treatment by industrial filtration or membrane technology based on PVDF material (or other fluoropolymers) was not mentioned in the Restriction Proposal, baseline data for this important use of PVDF (or other fluoropolymers) are not available. 1.5. Description of analytical methods Water samples of process water to be discharged into the sewerage were taken and analysed. The analytical method is described in the `confidential document': Emissions during manufacturing - Process wastewater - Measurements of process water to be discharged into the sewerage PFAS-Screening PFAS in process water / PFAS in oven condensate Measurement point: neutralization tank (just before entering the sewer system) Method: SAA-H-AOF.010: 2018-11: Adsorbable Organofluorine DIN 38407-42 (F42): 2011-03: PFAS substances EFW-MA-SP 56 (LCMS): 2018-05: PFAS: Total Oxidizable Precursor (TOP) Accreditation: DIN EN ISO/IEC 17025:2018 - DAkkS D-PL-14078-01-00 Laboratory report: provided in the `confidential report'. Berghof Membrane Technology GmbH | Arbachtalstrae 26 | 72800 Eningen | www.berghofmembranes.com 2023-05-30_Public Consultation_Berghof Membranes PUBLIC CONSULTATION | SUBMITTED ON 30.05.2023 1.6. Information on alternatives S. 12/20 Fouling / membrane surface charge PVDF membranes exhibit a lower fouling potential than PES membranes. This can be concluded from the zeta potential measurements presented in confidential document. The lower negative charge of the PES membrane surfaces are prone to foul more dramatically with positively charged fouling component. In e.g. MBR, the fouling components consists of a very broad mixture of various substances with various charges [Iorhemen 2016]. Aging of the membranes results in higher tendency of membrane fouling resulting in lower membrane performance. This is why membranes have to be exchanged when a certain level of irreversible fouling is reached. Chemical Resistance Hypochlorite stability (cleaning agent / oxidizing chemicals) The chemical stability is often measured on bulk materials and cannot easily be reflected to porous materials as they are applied in membrane technology. Supported membranes consist of thin and fragile structures with high porosity and defined pore size. The consequence is a very large contact surface area for chemical attack resulting in severe degradation of membranes. Therefore it is of great importance, that persistent membrane materials are used to ensure long lifetimes of the applied membrane modules. Li et al. investigated the effects of hypochlorite aging at different pH values on various membrane properties of PVDF and PES membranes [Li 2021]. This is very relevant, because membranes are often cleaned oxidatively in most tubular membrane module applications in water and wastewater treatment. For the PVDF membrane, NaClO aging at pH 3-11 caused a moderate increase in permeability and decreased retention due to the oxidation and release of a membrane additive. The tensile strength decreased only at pH 11 because of the defluorination of PVDF molecules. For the PES membrane, NaClO aging at all investigated pH resulted in chain scission of PES molecules, leading to deterioration of the membrane structure (very high permeability with very low retention). In addition, zeta potential measurements of PVDF and PES membranes were published showing the same trends as presented in section `Fouling / membrane surface charge'. Figure 5: Figure 8 and figure 9, taken from Li et al. showing the relative permeability and retention of PVDF (upper diagrams) and PES (lower diagrams) [Li 2022] Berghof Membrane Technology GmbH | Arbachtalstrae 26 | 72800 Eningen | www.berghofmembranes.com 2023-05-30_Public Consultation_Berghof Membranes PUBLIC CONSULTATION | SUBMITTED ON 30.05.2023 S. 13/20 Flexibility and mechanical stability of membrane layer Tubular ultrafiltration membranes are used in pressure-driven applications. Due to the applied pressure in the membrane tubes, elongation of the polyester support tube will take place and the membrane layer is subjected to mechanical stress. Arkema investigated and published the effect of various chemicals on the mechanical behavior of PVDF, PES and PSU [Arkema 2023]. PVDF showed the best mechanical properties in comparison to the others (Figure 6). This means PVDF will stay flexible after contact with chemicals or cleaning agents, resulting in less defects during operation. PVDF showed longer lifetime in halogenated environments. Figure 6: Chemical effect on elongation of PVDF; PES and PSU. Membrane lifetime The combination of the three previous sections, i.e. i) fouling / membrane surface charge; ii) chemical resistance; iii) flexibility and mechanical stability of membrane layer, leads to the following statement based on more than 2000 references worldwide [BMT 2023]: The lifetime of PVDF membranes ranges between 7-10 years and the lifetime of PES membranes ranges between 2-5 years. Membrane performance There are many studies where PES and PVDF are compared related to membrane performance. In many cases, pore sizes are not comparable or different membrane additives (determining the hydrophilicity of the membrane) are used, all resulting in applepear comparisons. Acarer et al. [Acarer 2021] studied to manufacturing and characterization of polymeric membranes and did a fair comparison between PVDF and PES (same amount of additive and comparable pore size. It was shown that permeability of PVDF membranes is approximately 2.5 times higher than PES membranes (Figure 7). Berghof Membrane Technology GmbH | Arbachtalstrae 26 | 72800 Eningen | www.berghofmembranes.com 2023-05-30_Public Consultation_Berghof Membranes PUBLIC CONSULTATION | SUBMITTED ON 30.05.2023 S. 14/20 Figure 7: Table on top: Membrane Pore Size diameters of the membranes; diagram on the left: flux values of membranes at different pressures; diagram on the right: permeability of membranes [Acarer 2021] It is often dependent on many factors why a certain polymer membrane is chosen for a certain application. In some sectors/applications PVDF clearly outperforms PES, e.g. water treatment by MBR technology, in other sectors/applications PES is advantageous. For instance, for wine filtration, typically PVDF hollow fiber membranes are used [Pall 2023(1)] and for beer filtration typically PES hollow fiber membranes are used [Pall 2023(2)]. Crucial for running the membrane systems is the membrane performance in combination with energy consumption, maintenance, chemical cleanings and membrane lifetime (module replacement, waste generation) and therefore it is necessary to choose the best material for the application. Alternatives-check by Chemservice Chemservice provided an analysis of alternatives to fluoropolymer and evaluated many case studies in many different sectors [Chemservice 2022]. Also Water Processing, application 5.2: Use of PVDF in the production of membranes for water treatment, was described and analyzed. They also found that PES was the only relevant alternative to PVDF. They described that PVDF has significant benefits over PES related to mechanical properties, especially related to chemical cleaning. Also the shorter membrane lifetime and lower performance were addressed. Additionally, they posted, that there are indications that PES may be related to equivalent concern as bisphenol A (BPA) due to potential endocrine disrupting properties. Conclusion The only technical and commercial relevant alternative to PVDF-based membranes in water treatment are PES-based membranes. The general properties of both materials related to its application differ in case of processing, fouling tendency, chemical stability (superior oxidative stability), mechanical behavior (i.e. flexibility), membrane morphology (i.e. pore size and porosity). There is simply no `one shoe fits all' in membrane technology. In some sectors/applications PVDF clearly outperforms PES, e.g. water treatment by MBR technology, in other sectors/applications PES is advantageous. Crucial for running the membrane systems is the membrane performance, energy consumption, maintenance, chemical cleanings and membrane lifetime (module replacement, waste generation) and therefore it is necessary to choose the best material for the application. References [Iorhemen 2016] Iorhemen et al., Membrane Bioreactor (MBR) Technology for Wastewater Treatment and Reclamation: Membrane Fouling, Membranes 6(2), 2016, 33 (https://doi.org/10.3390/membranes6020033) [Li 2021] Li et al., Aging of PVDF and PES ultrafiltration membranes by sodium hypochlorite: Effect of solution pH, J. Environ. Sci., 2021, 104, 444-455 (https://doi.org/10.1016/j.jes.2020.12.020) - due to copyright, attached in confidential section [Arkema 2023] Arkema, 2023, Kynar PVDF Water Filtration Membranes, https://hpp.arkema.com/en/markets-and-applications/water-andenvironment/water-filtration-membranes/, visited on 18.04.2023 Berghof Membrane Technology GmbH | Arbachtalstrae 26 | 72800 Eningen | www.berghofmembranes.com 2023-05-30_Public Consultation_Berghof Membranes PUBLIC CONSULTATION | SUBMITTED ON 30.05.2023 S. 15/20 [Acarer 2021] Acarer et al., Manufacturing and Characterisation of Polymeric Membranes for Water Treatment and Numerical Investigation of Mechanics of Nanocomposite Membranes, Polymers 13(10), 2021, 1661 (https://doi.org/10.3390/polym13101661) [BMT 2023] Berghof Membrane Technology. 2023, www.berghofmembranes.com, visited on 23.05.2023 [Pall 2023(1)] [Pall 2023(2)] Pall, 2023, OenoflowTM PRO XL-A Crossflow Microfiltration System, https://shop.pall.com/us/en/food-beverage/zidgri78j2q?CategoryName=food-beverage&CatalogID=food-beverage&tracking=searchterm:wine+filtration, visited on 27.04.2023 Pall, 2023, PROFi Membrane System For DE-free Clarification of Beer, https://shop.pall.com/us/en/products/systems/zidgri78lkm?CategoryName=systems&CatalogID=products&tracking=searchterm:beer+filtration+systems, visited on 27.04.2023 [Chemservice 2022] Chemservice, technical report - analysis of alternatives to fluoropolymers and potential impacts related to substitution in different sectors of use, Version 1, 19.7.2022, confidential document 1.7. Information on benefits We do not see any benefits related to the ban of fluoropolymers in general and PVDF in particular. On the other hand, we see the benefits of using PVDF as membrane material. This is shown exemplarily by means of two business cases, emphasizing that the benefits are NOT limited to these business cases! Case study: Grassland Dairy Products Inc. The application is Anaerobic Membrane Bioreactor (AnMBR) for a dairy processing company [Wiercinsky 2022]. PVDF membranes play a key role in producing biogas to generate electricity and reuse water by removing water from the biomass in the bioreactor. A total of 302 m wastewater can be reused daily by means of PVDF membranes for steam generation or cooling tower purposes. Additionally, a generator produces 9.000 kW of electricity per day (average of 4 GWh/year) with the produced biogas. The power for the AnMBR is generated completely by the produced biogas. PVDF membranes are crucial for anMBR systems concerning low fouling potential and low energy consumption [Wang 2018] Ban would cancel similar projects References [Wiercinsky 2022] [Wang 2018] Wiercinsky, Webinar: Convert your Waste to Energy with Anaerobic MBR on 20.09.2022, Presentation: A Sustainable Approach to Wastewater Treatment in Dairy Plants - due to copyright, attached in confidential section Wang et al., Comparison of fouling between aerobic and anaerobic MBR treating municipal wastewater, H2Open J., 2018, 1(2, 131-159 (https://doi.org/10.2166/h2oj.2018.109) Attachments: Case study: Grassland Dairy Products Inc. Case study: Thermal Solar Plant Mojave Desert This application concerns a Zero Liquid Discharge (ZLD) process in a Thermal Solar Plant in the Mojave Desert (California, USA). The goal with ZLD processes is to have no water discharge from the process and this can be achieved by processing and recycling the process water streams. In the first step, the source water (e.g. from a well or a cooling tower) is treated with reverse osmosis (RO). Normally, the concentrate from the RO process would be discharged as wastewater. In this ZLD process, the wastewater is further treated by adding chemicals to precipitate silica and calcium carbonate (lime softening). The precipitation works better at high pH values (10.5 - 11.5). PVDF tubular ultrafiltration membranes are used to reclaim water from the precipitated substances. Here PVDF is crucial due to its longterm chemical stability (high pH in combination with aggressive ionic substances). Subsequently, the permeate of Berghof Membrane Technology GmbH | Arbachtalstrae 26 | 72800 Eningen | www.berghofmembranes.com 2023-05-30_Public Consultation_Berghof Membranes PUBLIC CONSULTATION | SUBMITTED ON 30.05.2023 S. 16/20 the UF membranes is further processed with another RO, which is returned to the process or even used to generate drinking water (which is valuable for a desert area). With this ZLD process, for which PVDF membranes are crucial, approximately 6.700 m of water can be recycled each day. Ban would cancel similar projects or would be replaced by more sophistic technologies which are more energy intensive, more expensive and less reliable [Jimnez 2021] References [Jimnez 2021] Attachments: Jimnez, Conference: Mini and Micro RO desalination systems on 15.06.2021 - organized by Desalination Institute DME and IFAT (Germany). Presentation: Utilization of Tubular UF Membranes to treat RO brine in a Zero Liquid Discharge application at Thermal Solar Plant - due to copyright, attached in confidential section Case study: Thermal Solar Plant Mojave Desert 1.8. Other socio economic analysis (SEA) issues Berghof Berghof is a technology and family-owned company with 400 employees and 71 million EUR revenue (both numbers from 2021). Berghof consists of six different subsidiaries, i.e.: Berghof Membrane Technology GmbH Berghof Fluoroplastic Technology GmbH Berghof Products + Instruments GmbH Gigahertz-Optik GmbH Berghof Automation GmbH Berghof Environmental Engineering GmbH The contribution of Berghof Membrane Technology to the turnover of the whole Berghof Group is presented in the confidential document. Also a statement regarding the EBIT is given. Berghof Membrane Technology Employees Employee numbers of Berghof Membrane Technology are given in the confidential document. Revenue Revenue data are based on the period between 01.01.2017 and 05.04.2023. These data are presented in the confidential document. The possible PVDF restriction or ban in Europe has a tremendous impact on Berghof Membrane Technology. The company will not be competitive anymore outside Europe to other tubular membrane module manufacturing companies. In China we will lose our market share to direct local competition, like RisingSun Membrane Technology (China) and Kaimi (China). We will lose our market share in the USA to local competition as well, e.g. KOCH separation solutions (USA). Other European tubular membrane module manufacturers will suffer similar competitiveness issues. As soon the restriction enters into force, the business of the European companies will change from global to European. The consequence is overcapacity on the European market and a market shakeout. This means that European companies will probably relocate their business outside Europe or finally even go insolvent. The market for tubular polyether sulfone (PES) membranes is relatively small and mainly based in Europe. Investments and recruitment It should be mentioned, that the consequence of this proposal is the uncertainty it accompanies. This uncertainty results in stopping investments (or at least put them on hold) and delaying recruitment activities. Instead of moving forward, we are standing still. Berghof Membrane Technology GmbH | Arbachtalstrae 26 | 72800 Eningen | www.berghofmembranes.com 2023-05-30_Public Consultation_Berghof Membranes PUBLIC CONSULTATION | SUBMITTED ON 30.05.2023 S. 17/20 Conclusion As soon the restriction takes effect, it is expected that Berghof Membrane Technology will lose XX% (confidential document) of the business outside Europe, because we cannot meet the customer demands and we cannot offer competitive products. The European market has to switch from PVDF to PES based tubular membrane modules. The main global manufacturers of tubular membranes are located in Europe and a strong competition for a relatively small market will occur. Because of these uncertainties, Berghof Membrane Technology is probably forced to reduce capacities in a similar manner and it is very doubtful if Berghof Membrane Technology can continue its tubular membrane business at all. As an alternative, the production of Berghof Membrane Technology has to be transferred to outside of Europe resulting in losses of i. jobs, ii. taxes and iii technical/production knowhow. Berghof Membrane Technology is a significant pilar for the Berghof Group, which existence is highly endangered when tubular PVDF membrane modules cannot be manufactured anymore (in Europe). 1.9. Transitional period No information on this topic. 1.10. Request for exemption Important to note is that the our use of PVDF concerns water treatment by industrial filtration (membrane technology to be more precise). Tubular membrane modules are no consumer products! We have shown in our contribution to public consultation, that PVDF is a polymer of low concern (PLC) in terms of its potential environmental and human health impacts. Our supply chain is free of PFAS-of-concern and no such substances are emitted in our membrane manufacturing. PVDF membranes contribute significantly to water treatment in general and membrane bioreactors in particular. the best fit material for several applications should be applied, otherwise it results in higher energy consumption (CO2 emissions), increasing amount of cleaning chemicals, increasing waste due to shorter product lifetime. It will impact on the company tremendously in a negative context, possibly leading to factory shutdown or relocation outside Europe. Berghof Membrane Technology cannot comprehend the possible ban of fluoropolymers in general and PVDF in particular. We are not against a restriction/limitation of hazardous PFAS-of-concern, and supports a scientific approach differentiating high and low risk substances based on risk assessment. In that way, it should be concluded that fluoropolymers should not be treated in a similar way as other PFAS substances and should be taken out the ECHA restriction dossier. Fluoropolymers should be exempted from any regulatory action under the REACH restriction!! Berghof Membrane Technology GmbH | Arbachtalstrae 26 | 72800 Eningen | www.berghofmembranes.com 2023-05-30_Public Consultation_Berghof Membranes PUBLIC CONSULTATION | SUBMITTED ON 30.05.2023 2. Specific Information S. 18/20 2.1. Sectors and (sub-)uses Please specify the sectors and (sub-)uses to which your comment applies according to the sectors and (sub-)uses identified in the Annex XV restriction report (Table 9). If your comment applies to several sectors and (sub-)uses, please make sure to specify all of them. Answer: Missing use: Main application/Sector: Sub-use: Described in section 2.6. Water treatment* industrial filter / membrane filtration 2.2. Emissions in the end-of-life phase The environmental impact assessment does not cover emissions resulting from the end-of-life phase. To get a better understanding of the extent of the resulting underestimation, (sub-)use-specific information is requested on emissions across the different stages of the lifecycle of products, i.e. the manufacture phase, the use phase and the end-of-life phase. Please provide justifications for the representativeness of the provided information. In particular: a. Please provide, at the (sub-)use level, an indication of the share of emissions (as percentages) attributable to these three different stages. An indication of annual emission volumes in the end-of-life phase at sector or sub-sector level would also be appreciated. b. If possible, please provide for each (sub-)use what share of the waste (as percentages) is treated through incineration, landfilling and recycling. Please provide information to justify the estimates as well as information on the form of recycling referred to. Answer: Data are provided in section 1.3 of this report. 2.3. Emissions in the end-of-life phase With respect to waste management options, additional information is requested on the effectiveness of incineration under normal operational conditions (for different waste types, e.g. hazardous, municipal) with respect to the destruction of PFAS and the prevention of PFAS emissions. Answer: Data are provided in section 1.3 of this report. 2.4. Impacts on the recycling industry To get an understanding of the impacts of the proposed restriction on the recycling industry, information is requested on: a. The impacts that the concentration limits proposed in paragraph 2 of the proposed restriction entry text (see table starting on page 4 of the summary of the Annex XV restriction report) have on the technical and economic feasibility of recycling processes (together with a clear indication on the waste streams to which the described impacts relate). b. The measures that recyclers would need to take to achieve the proposed concentration limits. c. The costs associated with these measures. Answer: No comments. 2.5. Proposed derogations - Tonnage and emissions Paragraphs 5 and 6 of the proposed restriction entry text (see table starting on page 4 of the summary of the Annex XV restriction report) include several proposed derogations. For these proposed derogations, information is requested on the tonnage of PFAS used per year and the resulting emissions to the environment for the relevant use. Please provide justifications for the representativeness of the provided information. Answer: No comments. Berghof Membrane Technology GmbH | Arbachtalstrae 26 | 72800 Eningen | www.berghofmembranes.com 2023-05-30_Public Consultation_Berghof Membranes PUBLIC CONSULTATION | SUBMITTED ON 30.05.2023 S. 19/20 2.6. Missing uses - Analysis of alternatives and socio-economic analysis Several PFAS uses have not been covered in detail in the Annex XV restriction report (see uses highlighted in blue and orange in Table A.1 of Annex A of the Annex XV restriction report (page 5)). In addition, some relevant uses may not have been identified yet. For such uses, specific information is requested on alternatives and socio-economic impacts, covering the following elements: Missing uses: Main application/Sector: Sub-use: Water treatment* industrial filter / membrane filtration a. The annual tonnage and emissions (at sub-sector level) and type of PFAS associated with the relevant use. Answer: Data are provided in section 1.3 of this report. b. The key functionalities provided by PFAS for the relevant use. Answer: Data are provided in section 1.1, 1.6 and 1.7 of this report. c. The number of companies in the sector estimated to be affected by the restriction. Answer: Market description is given in section 1.1 of this report. d. The availability, technical and economic feasibility, hazards and risks of alternatives for the relevant use, including information on the extent (in terms of market shares) to which alternative-based products are already offered on the EU market and whether any shortages in the supply of relevant alternatives are expected. Answer: Alternatives are described in detail in section 1.6 of this report. e. For cases in which alternatives are not yet available, information on the status of R&D processes for finding suitable alternatives, including the extent of R&D initiatives in terms of time and/or financial investments, the likelihood of successful completion, the time expected to be required for substitution (including any relevant certification or regulatory approvals) and the major challenges encountered with alternatives which were considered but subsequently disregarded. f. For cases in which substitution is technically and economically feasible but more time is required to substitute: i. the type and magnitude of costs (at company level and, if available, at sector level) associated with substitution (e.g. costs for new equipment or changes in operating costs); ii. the time required for completing the substitution process (including any relevant certification or regulatory approvals); iii. 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); iv. information on the benefits for alternative providers. g. For cases in which substitution is not technically or economically feasible, information on what the socio-economic impacts would be for companies, consumers, and other affected actors. If available, please provide the annual value of EU sales and profits of the relevant sector, and employment numbers for the sector. Answer: Socio-economic impacts are described in detail in section 1.8 of this report. Berghof Membrane Technology GmbH | Arbachtalstrae 26 | 72800 Eningen | www.berghofmembranes.com 2023-05-30_Public Consultation_Berghof Membranes PUBLIC CONSULTATION | SUBMITTED ON 30.05.2023 S. 20/20 2.7. Potential derogations marked for reconsideration - Analysis of alternatives and socioeconomic analysis Paragraphs 5 and 6 of the proposed restriction entry text (see table starting on page 4 of the summary of the Annex XV restriction report) include several potential derogations for reconsideration after the consultation (in [square brackets]). These are uses of PFAS where the evidence underlying the assessment of the substitution potential was weak. The substitution potential is determined on the basis of i) whether technically and economically feasible alternatives have already been identified or alternative-based products are available on the market at the assumed entry into force of the proposed restriction, ii) whether known alternatives can be implemented before the transition period ends (taking into account time requirements for substitution and certification or regulatory approval), and iii) whether known alternatives are available in sufficient quantities on the market at the assumed entry into force to allow affected companies to substitute. A summary of the available evidence as well as the key aspects based on which a derogation is potentially warranted are presented in Table 8 in the Annex XV restriction report, with further details being provided in the respective sections in Annex E. To strengthen the justifications for a derogation for these uses, additional specific information is requested on alternatives and socio-economic impacts covering the elements described in points a) to g) in question 6 above. Answer: No comments. 2.8. Other identified uses - Analysis of alternatives and socio-economic analysis Table 8 in the Annex XV restriction report (starts on page 80) provides a summary of the identified sectors and (sub-)uses of PFAS, their alternatives and the costs expected from a ban of PFAS. More details on the available evidence are provided in the respective sections in Annex E. For many of the (sub-)uses, the information on alternatives and socio-economic impacts was generic and mainly qualitative. In particular, evidence on alternatives was inconclusive for some applications falling under the following (sub-)uses: technical textiles, electronics, the energy sector, PTFE thread sealing tape, non-polymeric PFAS processing aids for production of acrylic foam tape, window film manufacturing, and lubricants not used under harsh conditions. More information is needed on alternatives and socio-economic impacts to conclude on substitution potential, proportionality, and the need for specific time-limited derogations. Therefore, specific information (if not already included in the Annex XV restriction report or covered in the questions above) is requested on alternatives and socio-economic impacts covering the elements listed in points a) to g) in question 6 above. Answer: No comments. 2.9. Degradation potential of specific PFAS sub-groups A few specific PFAS sub-groups are excluded from the scope of the restriction proposal because of a combination of key structural elements for which it can be expected that they will ultimately mineralize in the environment. RAC would appreciate to receive any further information that may be available regarding the potential degradation pathways, kinetics or produced metabolites in relevant environmental conditions and compartments for trifluoromethoxy, trifluoromethylamino- and difluoromethanedioxy-derivatives. Answer: PVDF has no degradation potential to for short-chain PFAS-of-concern. This is elaborated in detail in section 1.3. 2.10. Analytical methods Annex E of the Annex XV restriction report contains an assessment of the availability of analytical methods for PFAS. Analytical methods are rapidly evolving. Please provide any new or additional information on new developments in analytics not yet considered in the Annex XV restriction report. Answer: Analytics for PFAS determination if provided in section 1.3 and 1.5. Berghof Membrane Technology GmbH | Arbachtalstrae 26 | 72800 Eningen | www.berghofmembranes.com 2023-05-30_Public Consultation_Berghof Membranes