Document p2pdazg8rNxBEN8eJxkrDwpaj

MEMOS NON-CONFIDENTIAL REPORT TO THE PUBLIC CONSULTATION ON THE REACH RESTRICTION PROPOSAL ON PER- AND POLYFLUOROALKYL SUBSTANCES (PFAS) Contents 1 MEMOS Company Profile ................................................................................................................ 1 2 MEMOS membranes ....................................................................................................................... 1 2.1 Process Description for PVDF (Polyvinylidene fluoride) membranes ..................................... 2 2.2 Emissions in the Manufacture phase ...................................................................................... 2 2.2.1 PFAS Emissions in the Wastewater ................................................................................. 2 2.2.2 PFAS Emissions in the Air ................................................................................................ 2 2.2.3 PFAS in Disposal............................................................................................................... 2 2.3 Emissions in the Use Phase: .................................................................................................... 2 3 Missing uses for PVDF membranes ................................................................................................. 3 3.1 PVDF Membranes in Water Treatment/Wastewater Filtration.............................................. 3 3.2 Fruit Juice Filtration................................................................................................................. 3 4 Socio-Economic Analysis ................................................................................................................. 4 5 Literature ......................................................................................................................................... 4 6 Annex............................................................................................................................................... 5 1 MEMOS Company Proile MEMOS Membranes Modules Systems GmbH is a small to medium-sized enterprise (KMU). We are an innova7ve and dynamic company in the field of membrane technology. With our own modern produc7on facili7es, we produce tubular membranes and tubular modules for ultrafiltra7on. Our efficient and high quality products are ,,Made in Germany". A quality management system reliably guarantees the high quality of our products and processes. 2 MEMOS membranes The core competence is the produc7on of especially stable ultra-filtra7on tubular membranes made of PVDF (Polyvinylidene fluoride) polymer. 1 2.1 Process Description for PVDF (Polyvinylidene luoride) membranes Our UF (ultrafiltra7on) tubular membranes are mainly made of PVDF as the main polymer. These membranes are manufactured using the NIPS (Non-Solvent-Induced Phase Separa7on) process. In the NIPS method, the polymer PVDF is first dissolved in a solvent. This PVDF solu7on is then applied to a nonwoven substrate under controlled condi7ons. This nonwoven carrier impregnated with the PVDF solu7on is immersed in a solvent-free (non-solvent) bath. During this step, the solvent is exchanged for the non-solvent, resul7ng in the forma7on of a polymer film - the membrane. The produc7on of these membranes takes place in closed facili7es where a constant ambient temperature and adequate ven7la7on are ensured. All safety measures as described in the safety data sheet for the safe handling of PVDF are strictly observed during the manufacturing process. 2.2 Emissions of PFAS in the Manufacture phase PVDF has a high molecular weight and is liBle to no water soluble and vola7le. Therefore, PVDF is not expected to degrade to lower molecular weight PFAS. The following emission pathways are examined in more detail below: 2.2.1 PFAS Emissions in the Wastewater Currently, monthly wastewater volumes in membrane produc7on amount to 100 m3. In the wastewater analysis conducted on 29th June 2023[Appendix A], no detectable traces molecular fragments of PVDF were found. 2.2.2 PFAS Emissions in the Air According to the safety data sheet, PVDF decomposes at temperatures exceeding 350C [5]. Such opera7ng temperatures are far from being reached in the produc7on process. Therefore, it can be assumed that there is no thermal release of PFAS and transfer into the air. 2.2.3 PFAS in Disposal The propor7on of PVDF in the waste is approx. 5 kg per month. The waste from membrane produc7on is collected weekly by a local disposal service and then incinerated in an incinera7on plant. 2.3 Emissions of PFAS in the Use Phase: The membrane module types used for the clarifica7on/concentra7on of fruit and vegetable juices have been tested for their suitability for food contact. Migra7on tests were conducted in accordance with the criteria of European regula7ons in Regula7on (EU) No. 10/2011. For our membrane filters, there is compliance evidence as food contact materials. The migra7on tests thus demonstrate that there is no leaching of harmful monomers or molecular fragments of PVDF [Appendix B]. 2 3 Missing uses for PVDF membranes The applica7ons of Polyvinylidene Fluoride (PVDF) membranes in water treatment/wastewater filtra7on and fruit juice filtra7on are currently not included in the proposal for restric7ons on PFAS in Annex XV. 3.1 PVDF Membranes in Water Treatment/Wastewater Filtration Our tubular membranes are widely used in membrane bioreactors (aerobic and anaerobic), industrial wastewater treatment, and process water recycling. Numerous studies indicate that over 60% of membranes used in water treatment and wastewater filtra7on, especially in MBR (membrane bioreactor) technology, are made of PVDF, and this trend is expected to con7nue to rise [1,2]. We also observe this trend in the adop7on of tubular membranes. Polysulfone and Polyethersulfone membranes are increasingly being replaced by PVDF membranes in exis7ng systems. This is primarily aBributed to the outstanding chemical proper7es and excellent an7-fouling behavior of PVDF. In prac7ce, for instance, UF (ultrafiltra7on) membranes are regularly cleaned with highly oxidizing solu7ons such as HNO3 or NaOCl in the pH range of 0 to 13 to remove inorganic and organic residues. Combined with PVDF's excellent an7-fouling proper7es, this leads to improved filtra7on characteris7cs and, consequently, significantly extended membrane lifespan. 3.2 Fruit Juice Filtration Ultrafiltra7on tubular membranes designed for use in food contact materials are u7lized for the clarifica7on of fruit and vegetable juices. Compared to conven7onal clarifica7on methods, ultrafiltra7on offers the following advantages: - Cost Reducon and Waste Reducon: The use of diatomaceous earth is eliminated, leading to a reduc7on in produc7on costs and minimizing waste disposal issues. - Improved Juice Clarity: UF membranes contribute to increased clarity of the juice. - Increased Product Yield: They enable a higher yield of the product. - Labor Costs: The use of UF membranes results in lower labor costs - Enzyme Recovery and Reuse: UF membranes allow for the recovery of enzymes for poten7al reuse, reducing the overall enzyme consump7on by approximately one-third. Over the last two decades, the use of PVDF membranes in this applica7on has increasingly gained acceptance over ceramic membranes and PES membranes. This trend is primarily due to the excep7onal material proper7es of PVDF, in par7cular its remarkable resistance to oxidizing substances and lower suscep7bility to fouling compared to PES [3,4]. Although ceramic membranes have some promising technical proper7es, such as good chemical resistance, heat resistance, and effec7ve an7-fouling behavior, their use as membrane materials is limited in prac7ce due to their high cost and suscep7bility to fracture. 3 4 Socio-Economic Analysis MEMOS specializes in the produc7on of PVDF tubular membranes, and we have an excellent reputa7on in this niche market. A ban on PVDF as a membrane material would have devasta7ng effects on our business, as our en7re revenue depends on these membranes. The transi7on to polymers under development with comparable proper7es to PVDF would be a major challenge and would require an extensive development and tes7ng phase of more than 15 years. Restric7on of PVDF would mean that we would have to switch to exis7ng materials such as PES. However, this would mean that we would no longer have a compe77ve product on the market, resul7ng in a loss of market share. Our non-European customers, especially in the lucra7ve markets in China and the USA, would migrate to local membrane manufacturers who are not affected by the ban and con7nue to supply the nonEuropean market with PVDF membranes. Such a situa7on would lead to significant job losses and, in the worst case, could result in the closure of our company with all 20 employees. In response, we could be forced to sell the company or transfer our specialized know-how in membrane produc7on to interested par7es outside Europe. 5 Literature [1] Judd, S., 2017. The material ques7on - choosing MBR membrane materials (hBps://www.thembrsite.com/blog/choosing-mbr-membrane-materials/, update April 23, 2022) [2] i Pearce, G., 2019. Microfiltra7on and Ultrafiltra7on Market Report, s.l.: Membrane Consultancy [3] Ata, M., Yilmaz, ., Dilaver, M. et al. Pilot-scale ceramic ultrafiltra7on/nanofiltra7on membrane system applica7on for caus7c recovery and reuse in tex7le sector. Environ Sci Pollut Res 28, 41029- 41038 (2021) [4] KYNAR & KYNAR FLEX PVDF. PERFORMANCE CHARACTERISTICS & DATA. THERMOPLASTICS FOR ENGINEERING APPLICATIONS. 2007 Arkema Inc. [5]Plas7cs Europe, 2021 Guide for the Safe Handling of Fluoropolymer Resins 4 6 Appendices Appendix A: SGS Analy7cs Germany GmbH, Wastewater Analysis for PFAS // #23222 dated June 29, 2023 5 %tz eurofins Eurofins Institut Nehring GmbH Heesfeld 17 38112 Braunschweig T: +49 531 23899-0 F: +49 531 23899-77 IIMI@eurofins.de www.eurofins.de EUROFINS INSTITUT NEHRING GmbH - Heesfeld 17 - 38112 Braunschweig MEMOS Membranes Modules Systems GmbH Memmelers Wiese 23 D-72793 Pfullingen Germany December 1, 2020 page 1 of 2 Your ref. 21.08.2020/Dr. A. Schbler Our ref.mocument 2150-091-02_JHWC +49 531 23899-0 Copy of our confirmation 2036-028-02 WJWC of December 1, 2020 CONFIRMATION Membrane elements ME-C65 and ME-C100 The membrane elements ME-C65 and ME-C100 with the membrane material type VFU250 resp. VFU100 consisting of epoxy resin bonding, tubular membrane and fabric stocking are intended to be used for the filtration of fruit juices as well as milk and dairy products. These membrane elements differ in their composition of the membrane material only slightly from already investigated materials, therefore in our opinion no significant deviation in food law conformity is to be expected. The already investigated membrane elements were tested by us regarding their composition, and specific migration tests were carried out considering the field of application (our test report 2036-028_D_WJWJ of November 26, 2020). The membrane elements ME-C65 and ME-C100 meet the requirements according to 30 and 31 (1) of the Lebensmittel- and Futtermittelgesetzbuch (LFGB) and Art 3 of Regulation (EC) No 1935/2004 in conjunction with Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food, each in the currently valid version, with regard to the characteristics checked within the scope of the above-mentioned assessment under the conditions of intended and expected use. Die Pruferge.sse bevehen sich auss..61.0 au, me erhallenen oder bascnallten Prulgegensia., Jade Vero, enl4chu, mesas Elarichts bedarf saner schnlachen Genann,gung Ene aussugswelse Ve..ral.chum 'EA night erleubl. Eurofins Institut Nehring GmbH Heesfeld 17. 38112 Braunschweig Amtsgericht Braunschweig, FIRS 2695 Geschaftsfuhren Thomas Gerlach, Dr. Katrin Hoenicke USt.-IdNr.: DE 114 882 606 UniCredit Bank, Kontonumrner 7000003750, BLZ 20730017 IRAN DE34 2073 0017 7000 0037 50, SWIFT-BIC: HYVEDEMME17 nach DIN EN ISO/IEC 17025 akkreditiertes Prii(Mbor Deutsche Akkreditieningsstelle (DAkkS) D-PL-19570-02D0 6 Appendix B: Compliance Confirma7on from EUROFINS INSTITUT NEHRING GmbH dated November 26, 2022 7