Fluoropolymers have an extreme high chemical stability. However, this stability also means that - once released into the environment - they can remain there for a very long time and cause environmental damage. The EU is planning to restrict or ban perfluorinated and polyfluorinated alkyl substances (PFAS), which include PTFE, for example, in the future. This would have serious consequences for plants in the pharmaceutical industry, for example, where PTFE is used as a material for seals.
含氟聚合物具有極高的化學穩定性。然而，這種穩定性也意味著 - 一旦釋放到環境中- 它們可以在那里停留很長時間并造成環境破壞。歐盟正計劃在未來限制或禁止全氟和多氟烷基物質（PFAS），其中包括PTFE（聚四氟乙烯）。這將對制藥行業的工廠產生嚴重后果，例如，PTFE被用作密封件的材料、某些疏水性過濾器、模具、護欄等。
Although it has been under discussion for some time, not everyone is aware that the production and thus the availability of PTFE (known to many under the brand name "Teflon"), among other things, is currently being put to the test.
盡管已經討論了一段時間，但并不是每個人都知道PTFE（許多人以“特氟龍”品牌名稱而聞名）的生產以及可用性目前正在接受檢測。
Restrictions and bans on fluorinated hydrocarbons have been in place for some time. In 2006, the EU Directive 2006/122/EC restricted the use of perfluorooctane sulfonic acid (PFOS). This was later followed by the restriction of perfluorooctanoic acid (PFOA) by EU Regulation 2020/784.
對氟化碳氫化合物的限制和禁令已經存在了一段時間。2006年，歐盟指令2006/122/EC限制全氟辛烷磺酸（PFOS）的使用。隨后，歐盟法規 2020/784 對全氟辛酸 （PFOA） 進行了限制。
European Chemical Agency plans ban or restriction of PFAS substances
歐洲化學品管理局計劃禁止或限制PFAS物質
However, the current discussion goes considerably further: the European Chemical Agency (ECHA) plans to ban perfluorinated and polyfluorinated alkyl substances (PFAS).
然而，目前的討論更進一步：歐洲化學品管理局（ECHA）計劃在未來禁止全氟和多氟烷基物質（PFAS，包括PTFE）。
"phasing out the use of per- and polyfluoroalkyl substances (PFAS) in the EU, unless their use is essential"
“歐盟將逐步停止使用全氟烷基物質和多氟烷基物質 (PFAS，包括PTFE)，除非必須使用它們”
PFAS cause contamination in soils and drinking water, among other things, and there is justified concern that these issues are increasing due to the persistence of these substances. Some PFASs are classified as persistent, bioaccumulative and/or toxic. Even in waste incineration, some of these substances cannot be degraded as they are destroyed only at temperatures above 1,000°C.The use of these substances should therefore be phased out unless it can be proven that they are indispensable for the public good ("unless their use is essential").
PFAS會導致土壤和飲用水等污染，并且有理由擔心由于這些物質的持久性，這些問題正在增加。一些PFAS被歸類為持久性，生物蓄積性和/或毒性。即使在垃圾焚燒中，其中一些物質也無法降解，因為它們只有在1000°C以上的溫度下才會被銷毀。 因此，應逐步淘汰這些物質的使用，除非能夠證明它們對公共利益是不可或缺的（“除非它們的使用是必要的”）。
The planned bans would predictably lead to cuts in production, supply chains and availability problems. PFAS are also used in large quantities in water-repellent clothing materials or fire-fighting foams. Substitute materials are already being intensively sought for these applications, as the environmental impact is particularly high there.
可以預見，該禁令計劃將導致生產、供應鏈和可用性問題。PFAS還大量用于防水服裝材料或消防泡沫中。人們已經在為這些應用密集尋找替代材料，因為對環境的影響特別大。
Switching to alternative materials is usually complicated in the GMP environment. The required EU/FDA material certifications and, in some cases, the approvals of medical devices and/or medicinal products themselves, if PTFE is mentioned there in any form, stand in the way.
在GMP環境中，切換到替代材料通常非常復雜。所需的歐盟/FDA材質認證，以及在某些情況下，醫療器械和/或醫藥產品本身的批準，如果以任何形式提及PTFE，都會成為障礙。
In principle, one wants to allow exceptions to the ban for essential applications. It is quite certain that these approvals would be granted for the hundreds of applications in the field of medical technology, pharmaceuticals and biotechnology. However, the manufacturers and/or users would have to apply for and justify such exceptions in each individual case - including evidence that chemically unproblematic alternatives have been sought.
原則上，人們希望允許對必要的應用進行例外。可以肯定的是，這種批準將授予醫療技術，制藥和生物技術領域的數百項申請。然而，制造商和/或用戶必須在每個個案中申請并證明這種例外情況的合理性，包括證明已經尋求化學上沒有問題的替代品的證據。
The BDI writes in its assessment of the planned restriction procedure: (only available in German language).
BDI在其對計劃的限制程序的評估中寫道：
A lack of viable alternatives to PFAS substances means high costs when trying to replace them.
缺乏PFAS物質的可行替代品意味著在嘗試替代它們時成本很高。
Due to the often highly complex international supply chains ...there is a high risk of unforeseen disruptions of the supply chains with all the associated economic impacts.
由于通常高度復雜的國際供應鏈...供應鏈發生不可預見的中斷以及所有相關經濟影響的風險很高。
A precise impact analysis per substance therefore requires sufficient time, which unfortunately is not currently granted.
因此，對每種物質進行精確的影響分析需要足夠的時間，遺憾的是，目前尚未給予時間。
Users of PTFE and similar fluoropolymers - especially from the pharmaceutical or medical technology sectors - should address this issue and consider becoming actively involved in the ongoing discussion on the regulation of PFAS.
PTFE和類似含氟聚合物的用戶 - 特別是來自制藥或醫療技術領域的用戶 - 應該解決這個問題，并考慮積極參與正在進行的關于PFAS監管的討論。
The European Chemicals Agency (ECHA) had started a consultation on possible restrictions or the ban of PFAS under REACH. Here, affected groups or associations can gatherarguments for an exemption regulation.
歐洲化學品管理局（ECHA）已開始就REACH下PFAS的可能限制或禁令進行磋商。在這里，受影響的團體或協會可以為豁免法規收集論據。
