Document YjXKrnLn3Q0d3jD1kgjdvgGXn

PFAS PUBLIC CONSULTATION: BRIEF PFAS IN MEDICAL DEVICES, VETERINARY MEDICINE, RESEARCH AND LIFE SCIENCE Brussels, 25 September 2023 EuPC is the leading EU-level Trade Association, based in Brussels, representing European Plastics Converters. EuPC now totals about 51European Plastics Converting national and European industry associations, it represents close to 50,000 companies, producing over 50 million tonnes of plastic products every year. The European plastics industry makes a significant contribution to the welfare in Europe by enabling innovation, creating quality of life to citizens and facilitating resource efficiency and climate protection. More than 1.6 million people are working in about 50,000 companies (mainly small and medium-sized companies in the converting sector) to create a turnover in excess of 280 billion per year. Introduction Following our initial submission, EuPC intends to comment on specific applications. Since those are very diverse, each will be covered in a separate submission. This brief covers Medical Devices, Veterinary Medicine and Life Science. This submission is built upon a survey conducted across the plastics converters sector, including the whole supply chain. The applications referred to in this brief do not represent an exhaustive list, if anything, a description of the wide range of PFAS applications within the medical and life science sector. Use of PFAS in medical devices and packaging, life science and veterinary applications Due to its unique properties, PFAS are used in a broad variety of applications. Within the sector of medical and veterinary devices and life science, following uses have been reported: Uses in medical devices Metered dose inhalers (Drug Powder Inhalers) Pen Injectors Catheters (For more information, please see Annex: FEP and PTFE used in PTCA catheters) Process fluid connectors Compounds used for technical applications Use of PFAS in life science and research Beakers Funnels Spatulas Stirring Bars Scoops Bottles Avenue de Cortenbergh 71- B-1000 Brussels Phone: +32 (0)2 732 41 24 Fax: +32 (0)2 732 42 18 @eupc.org www.plasticsconverters.eu Page 1 of 6  Fittings Clamps Valves O-Rings and sealants Connectors Racks Containers Liners used inside caps of bottles Filters Piping and tubing Measuring Cylinders High Performance Liquid Chromatography (HPLC) Safety Caps HPLC Liquid Waste Handling & Joints HPLC Syringes Liquid Chromatography/Gas Chromatography Microsyringes Processing reactors Filtration membranes Coating for rubber stoppers in prefilled syringes or cartridges Use of PFAS as additive in films PE/EVOH/PE films for pharmaceutical applications PE/EVOH/PE films used for veterinary applications Use of PFAS in medical packaging Pharmaceutical blister packaging Coating for primary packaging Further applications of PFAS Processing aids Process chemicals like solvent or reagents Manufacturing of medicines and vaccines No hazardous properties justifying a restriction Fluoropolymers are very stable because of their intrinsic physicochemical properties. If lost in the environment, they are therefore currently considered as persistent. However, they do not display any hazardous property/property of concern referred to by the dossier submitter; i.e., bioaccumulation, mobility, long-range transport potential (LRTP), accumulation in plants, ecotoxicity, endocrine activity/endocrine disruption, effects on human health and concerns triggered by a combination of these properties. Avenue de Cortenbergh 71- B-1000 Brussels Phone: +32 (0)2 732 41 24 Fax: +32 (0)2 732 42 18 @eupc.org www.plasticsconverters.eu Page 2 of 6 Moreover, the fluoropolymers PTFE, FEP, PFA, PVDF and PCTFE meet the OECD criteria for polymers of low concern [Henry, B.J., Carlin, J.P., Hammerschmidt, J.A., Buck, R.C., Buxton, L.W., Fiedler, H., Seed, J. and Hernandez, O. (2018), A critical review of the application of polymer of low concern and regulatory criteria to fluoropolymers. Integr Environ Assess Manag, 14: 316-334. https://doi.org/10.1002/ieam.4035; Korzeniowski, S. H. et al. A critical review of the application of polymer of low concern regulatory criteria to fluoropolymers II: Fluoroplastics and fluoroelastomers. 2022. https://setac.onlinelibrary.wiley.com/doi/ful1/10.1002/ieam.4646]. Fluoropolymers should be excluded from the scope of the restriction Based on the above, fluoropolymers and PFAS used in the fields of medical devices and life science should in our view excluded from the scope of this restriction. We however provide additional information showing both its negligible emission and the disproportionate socio-economic impact that would be linked to its substitution. Needed transition period combined with a review clause In the event it is determined that medical devices shall not be excluded from the scope of the restriction, then our analysis suggests that the industry would need a minimum of a transition period of Entry into Force +13.5 years to discover suitable alternatives. For catheters we request a transition period of at least 20 years. There is currently considerable uncertainty whether or not suitable alternative can be Implemented at industrial level within the proposed transition periods. The restriction should therefore include a review clause and process whereby it may be evaluated whether or not the alternatives could be successfully placed on the market potentially allowing if needed extension of those transition periods. Note: the following sections numbers correspond to the sections numbers from ECHA's Comments for Annex XV restriction report for Per- and polyfluoroalkyl substances (PFAS). 1. Sector and sub-use This comment is related to the following use: Medical devices and Life Science The following fluoropolymers have been reported as used in medical devices: PTFE (EC number: 618-337-2, CAS number: 9002-84-0) PFPE (Poly[oxy[trifluoro(trifluoromethyl)-1,2-ethanediyl]], a-(1,1,2,2,2-pentafluoroethyl)-w- [tetrafluoro(trifluoromethyl)ethoxy], EC number: 611-940-1, CAS number: 60164-51-4) PFA (Perfluoroalkoxy alkanes, CAS 26655-00-5/ 31784-04-0) PCTFE (Fluoropolymer PolyChloroTriFluoroEthylene, EC number: 618-336-7, CAS number: 9002-83-9) PVDF (CAS number: 24937-79-9) FEP (CAS number: 25067-11-2) Avenue de Cortenbergh 71- B-1000 Brussels Phone: +32 (0)2 732 41 24 Fax: +32 (0)2 732 42 18 @eupc.org www.plasticsconverters.eu Page 3 of 6 Additionally, the following PFAS are used as additives during manufacturing of films: Hexafluoropropylene Vinylidene Fluoride 2. Emissions during the end of life According to a recent study conducted by Conversio on behalf of ProK, it has been found that the disposal of medical and pharmaceutical waste predominantly involves incineration, accounting for approximately 90 % of the total waste generated. On the other hand, landfill disposal constitutes only 7 % of the overall waste generated in this sector -- see p. 39, ratio recalculated excluding metal. Additionally, there are some recycling efforts, 3 %, particularly in the form of mixed plastics recycling sourced from household waste [Fluoropolymer Waste in Europe 2020 -- End-of-life (EOL) Analysis of Fluoropolymer Applications, Products and Associated Waste Streams." Final Report Made on Behalf of pro-K, Conversio. July 2022., https://www.ft.dk/samling/20222/almdel/euu/spm/49/svar/1951975/2698345.pdf]. It is essential to highlight that, according to WHO guidelines, incineration is highly recommended for the disposal of uncontaminated medical packaging [WHO Technical Report Series (2002), Guidelines on packaging for pharmaceutical products, Table 2: Methods of disposal of uncontaminated packaging, pp. 140, No. 902, https://cdn.who.intimedia/docsidefault-source/medicines/norms-and-standards/guidelines/regulatory-standards/trs902annex9.pdf?sfvrsn=82b4c57d 2]. For behaviour in incineration, see the next section. 3. Emissions from incineration As stated above, around 90 % of the fluoropolymer waste from medical and pharmaceutical applications is incinerated. Incineration above 850 C does not release PFAS-related materials nor detectable levels of Trifluoroacetic acid (TFA) [Aleksandrov, K. Waste Incineration of Polytetrafluoroethylene (PTFE) to Evaluate Potential Formation of Per- and Poly-Fluorinated Alkyl Substances (PFAS) in Flue Gas. 2019, 226, 898-906., DOI: https://doLorg/10.1016/j.chemosphere.2019.03.191; Taylor, P. H. Investigation of Waste Incineration of Fluorotelomer-Based Polymers as a Potential Source of PFOA in the Environment. Chemosphere 2014, 110, 17-22, DOI: https://doi.orq/10./0/6/j.chemosphere.20/4.02.037; Bakker, J., et al. (2021) Per- and Polyfluorinated Substances in Waste Incinerator Flue Gases. Rijksinstituut voor Volksgezondheid en Milieu (RIVM) Report 2021-0143.DOl: https://doi.orq//0.2/945/RIVM-2021-0143)1, Gujarat Fluorochemicals Limited (GFL), Karlsruhe Institute of Technology (KIT) & Societe Generale de Surveillance (SGS) consulted by the German Federal Environment Agency (UBA), Incineration study on Fluoropolymers at their End-of-Life, https://www.gfl.co.in/upload/pages/64ca54ee691b6f4a8b2649ec9c7b291f.pdf]. Those temperatures can be found in municipal waste incinerators, as they are mandatory according to the Industrial Emissions Directive 2010/75/EU (Article 50), which prescribes that waste incineration plants must be designed to ensure that flue gases reach a temperature of at least 850 C for at least 2 seconds in order to ensure the proper breakdown of toxic organic substances). Avenue de Cortenbergh 71- B-1000 Brussels Phone: +32 (0)2 732 41 24 Fax: +32 (0)2 732 42 18 @eupc.org www.plasticsconverters.eu Page 4 of 6 5. Proposed derogation tonnage and emissions 5.1. Related emissions during manufacturing of fluoropolymers Concerning the fluoropolymer manufacturing stage, the Fluoropolymers Product Group (FPG) of Plastics Europe established a program focusing on the emission reduction of non-polymeric PFAS chemicals from European fluoropolymer manufacturing, including average emission targets, promoting state-of-the-art technologies to minimize emissions and a commitment to inform downstream users of fluoropolymers on their safe handling of fluoropolymer resins [The Fluoropolymers Product Group (FPG), Plastics Europe (2023), FPG Manufacturing Programme for European Manufacturing sites, https://fluoropolvmers.eu/wp-content/uploads/2023/09/FPG-Manufacturing-Programme-for-European-Manufacturinqsites-Final-September-2023.pdA 5.2. Emissions during masterbatching, compounding and converting stage and service life As stated in the Annex XV report, polymeric PFASs considered to be stable up to 300 C [Section 8.9.11.3 of Annex B of the Annex XV Restriction report]. During the masterbatching, compounding and converting process the spillage of pellets is negligeable, there is only presence of dustiness; although air filters reduce the risk of emitting dust, as well as the presence of filters in water drains prevents the emission into water. During manufacturing of medical devices, such as pen injectors and metered drug inhalers, temperatures of 300 C are not exceeded. For PFAS used as a high-performance barrier layer, efficiently laminated with other polymer layers such as PE and EVOH, the lamination process takes place within the temperature range of 15 - 80 C, ensuring that the film remains stable without experiencing any degradation. During service life, common room temperatures are expected for most applications. Therefore, no significant emissions are expected during manufacturing and service life and the exposure of workers or consumers is assumed to be low. 7. Derogation for reconsideration: information on socio-economic impact and analysis of alternatives 7.1. Properties of PFAS used in medical devices PTFE and PFPE oils show very specific properties during manufacturing of medical devices, such as chemical inertness and self-lubricity. Those can be considered as key to some medical device functions and performances, used in pen injectors, drug powder inhalers and process fluid connectors. Moreover, PTFE is used as a filler embedded in other polymer matrixes. As a tribological modifier it decreases friction between the plastic components. Besides that, PTFE can be found in liners inside of caps of bottles for aggressive chemicals. Due to its high resistance to acids and other aggressive media, compared with its low extractables/ leachable profile and chemical inertness, PTFE is reported as the only suitable substance for this application. Avenue de Cortenbergh 71- B-1000 Brussels Phone: +32 (0)2 732 41 24 Fax: +32 (0)2 732 42 18 @eupc.org www.plasticsconverters.eu Page 5 of 6 PTFE is used in PTCA catheters and guidewires due to its low friction, lubricity, biocompatibility, chemical resistance, visibility and radiopacity. FEP provides the necessary properties of lubricity, biocompatibility, flexibility, and non-reactivity, making it a crucial material for PTCA catheters and guidewires. Without FEP, these devices would be less efficient, more traumatic, and potentially harmful to the patient. For more information, please see Annex: FEP and PTFE used in catheters. 7.2. Time needed for substitution For the time being, no suitable alternatives have been identified and research is still ongoing. Taking into account the requalification requirements in the medical sector, a derogation period of Entry into Force +13.5 has to be granted to ensure and constantly protect public health. There is no known alternative for PTFE and FPE in the inner lining and heat-shrinkage material for PTCA catheters and diagnostic catheters. Therefore, we ask for a time unlimited exemption for this application, otherwise a transition period of minimum 20 years has to be granted. The availability of PCTA catheters that impact over 1,0 million patients that are at risk to be confronted with supply chain shortages and may affect their access to life-saving cariological surgical interventions. Conclusion/Summary Based on the above, fluoropolymers should in our view excluded from the scope of this restriction. The transition to alternative substances necessitates an adjustment period in terms of industrial practices and requalification procedures to meet the regulatory standards applicable to medicinal and medical devices applications. For this, certain time lapses exist that, if not provided with a minimum transition period of Entry into Force +13.5 years, will compromise the supply of some medicinal/medical devices, which are essential for society and human wellbeing. For catheters we request a transition period of at least 20 years. Contact: @eupc.org; @eupc.org Avenue de Cortenbergh 71- B-1000 Brussels Phone: +32 (0)2 732 41 24 Fax: +32 (0)2 732 42 18 @eupc.org www.plasticsconverters.eu Page 6 of 6