Document Rp3GpJ0Gp4vmYDn4mbpNop7ea

Impact of the current draft of the PFAS proposal on connections and seals for food, beverage, chemical and pharmaceutical applications Dear ECHA Committee Members, We are a middle-sized company located in Germany producing valves for the dairy and beverage as well as for the pharmaceutical and chemical industry. We produce with roughly 300 employees about 60.000 valves per year. We are part of the larger enterprise located in the US. We would like to take the opportunity to comment on the current proposal of the PFAS regulation for the European Union and share our views how it will affect our own, but also the industries of our customers. As a general introductory note, we would like to emphasize, that we generally welcome the initiative to restrict the emission of PFAS. Chemical substances which bear a risk to have a negative impact on the environment, on the health of humans and animals should be closely evaluated considering the individual risk of each substance. Significance of fluorinated polymers Per definition valves allow and prevent the flow of media, in our case fluids. The shut-off elements in every valve need to be sealed. For this purpose, we - like all other valve manufactures - use sealing products in our valves. The specialty of our valves is, that they are designed to be easily cleaned without any dead spaces. The design follows best practice rules of EHEDG and are in accordance with EU and other regional regulations with respect of machines in contact with food like (EC) No 1935/2004, (EU) No 10/2011 or 3-A Sanitary Standards. This requires additionally that only materials are used which are approved by local authorities like FDA in the US (CFR Title 21 177.2600 and 177.1550, PMO) and others. Depending on the application the sealing products are made of EPDM, HNBR, VMQ but also of the fluorinated polymers FKM and PTFE. In contrast to EPDM, HNBR and VMQ, FKM and PTFE have unique mechanical, chemical, and physical properties, which are vital for the processes involved in the production of food, beverages and pharmaceutical products. To fulfil the requirements of a hygienic or even aseptic production, regular cleaning cycles are essential. The cleaning agents range from water, steam, several kinds of acids, caustic soda to disinfectants. The following list gives an overview on the involved requirements: Requirement Temperature Products Cleaning agents Details 2 C up to 130C continuous, up to 150C short time (20 minutes) Beer and all upstream products Dairy products (milk, yoghurt, curd etc) Soft drinks Coffee concentrate Light chemicals Pharmaceutical products Water Steam Sulfuric acid, 5% Nitric acid, 5% Phosphoric acid, 5% Peracetic acid, 1% Caustic soda, 5% It is generally known that most of the requirements can be fulfilled by EPDM 1 . However, in some products there are fatty or oily products present like in milk or some fruits (e.g. limonene), where EPDM is not suitable because of chemical attack and extensive swelling, whereas HNBR or VMQ have limitations in the temperature stability. In these cases, the only solution is to use FKM or PTFE as sealing elements. Considering the prices of EPDM and FKM/PTFE, the fluorinated polymers are roughly a factor 3 to 4 higher in price.2 Therefore, operators in food and beverage and pharmaceutical industries use FKM/PTFE only if it is absolutely necessary for the application. Risk for health of fluorinated polymers FKM and PTFE The fluorinated materials FKM and PTFE have been tested excessively in the different applications for food, beverage, chemical and pharmaceutical applications. Depending on the customer's application some of the materials underwent even pharmaceutical compliance testing according to United States Pharmacopeia (USP) chapter <87> (in vitro) and/or USP chapter <88> (in vivo). Further testing is done according to food contact legislations around the world, depending on the application. In order not endangering human health, this excessive regime of testing is required by law and proves the harmlessness of these materials. Finally, the OECD has classified these materials as "materials of low concern"3. Studies concluded that "fluoropolymers are distinctly different from other polymeric and nonpolymeric PFAS and should be separated from them for hazard assessment or regulatory purposes." 4. Concerning potential biohazards, it was found that "Fluoropolymers have documented safety profiles; are thermally, biologically, and chemically stable, negligibly soluble in water, nonmobile, nonbioavailable, nonbioaccumulative, and nontoxic."5 1 www.trelleborg.com/seals/-/media/tss-media-repository/tss_website/pdf-and-other- literature/brochures/mat_chem_comp_de.pdf?rev=-1?&openpdf=1 2 Internal figures and calculations 3 www.oecd.org/env/ehs/risk-assessment/42081261.pdf 4 B.J. Henry et. al., Integr Environ Assess Manag. 2018 May;14(3):316-334 5 S.H. Korzeniowski et al., Integr Environ Assess Manag. 2023 Mar;19(2):326-354. Alternatives to fluorinated polymers The reason for the unique properties of fluorinated polymers is the chemical nature of the Carbon-Fluor-Bond, which is one of the strongest known in chemistry. This chemical nature gives the material its beneficial properties for technical applications. Therefore, it is very doubtful that replacing the fluorine will lead to a material with the same or similar properties. On the other hand, the chemical nature is also responsible for the persistence in nature. Thus, if the committee was to decide to exempt fluorinated polymers like FKM/PTFE, it could become important to implement a stringent process, which safely prevents the emission of these materials into the environment after the normal service life. There have been several scientific analyses dealing with the upcycling of polymeric PFAS6. One safe treatment of waste of fluorinated polymers could be incineration, as it was shown, that there is no emission of secondary PFAS during incineration of PTFE 7. A consequence of running productions of beverages, dairy and pharmaceutical products without FKM/PTFE could be the need to adapt the production processes towards less aggressive cleaning procedures. In all these industries product safety with respect to hygiene or sterility is the most important task. Therefore, jeopardizing the hygiene or sterility of the products by using less aggressive cleaning chemistry is not an option. Additionally, products with a fat or oil content still would pose a problem. Consequence of a ban of fluorinated polymers Pentair Sdmo produces about 20.000 8valves containing at least one piece of fluorinated polymer as sealing element. For this significant portion our customers would have to accept not-PFAS materials leading to severe consequences. Production of beverages, dairy products, and pharmaceutical products without the use of fluorinated sealing material will lead to significantly higher down times at the production sites, more waste because of contamination, higher production costs and higher danger of product contamination, because of more frequent breakdown of seals. As an effect prices for beer, soft drinks, dairy and pharmaceutical products will rise. Depending on the market response this could lead to a dramatically decrease in business of these industries and consequently a significant loss of jobs. Additionally, the feedback from our customers is quite straightforward: Wherever possible, this would be a reason to move production out of the EU into countries allowing the use of the needed sealing technology. Recommendation With the prerequisites and provisions mentioned above about the usage of sealing materials in valves for the beverage, dairy and pharmaceutical industry, and considering that fluorinated polymers are non-toxic and can be handled in a safe way it is our strongest belief, that a ban of usage of fluorinated polymers for sealing applications is counterproductive for a sustainable and safe future. Therefore, we strongly ask the responsible committees to exempt polymeric, long-chain materials used for sealing applications within the industry from the current PFAS legislation. We kindly ask you to take these considerations specific to the food, beverage, dairy and pharmaceutical industry into account before any final decisions on the ban of all fluoropolymers and fluor elastomers are taken. 6 www.pro-kunststoff.de/fachwissen/recycling-of-fluoropolymers.html 7 Krasimir Aleksandrov et al., Chemosphere 226 (2019) 898e906 8 Internal figures and calculations