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(xué)穩(wěn)定性。然而，這種穩(wěn)定性也意味著 - 一旦釋放到環(huán)境中- 它們可以在那里停留很長時間并造成環(huán)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(zhì)（PFAS），其中包括PTFE（聚四氟乙烯）。這將對制藥行業(yè)的工廠產(chǎn)生嚴(yán)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(hù)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(jīng)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(chǎn)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?xì)浠衔锏南拗坪徒钜呀?jīng)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(guī) 2020/784 對全氟辛酸 （PFOA） 進(jìn)行了限制。
European Chemical Agency plans ban or restriction of PFAS substances
歐洲化學(xué)品管理局計劃禁止或限制PFAS物質(zhì)
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(jìn)一步：歐洲化學(xué)品管理局（ECHA）計劃在未來禁止全氟和多氟烷基物質(zhì)（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(zhì)和多氟烷基物質(zhì) (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(dǎo)致土壤和飲用水等污染，并且有理由擔(dān)心由于這些物質(zhì)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(zhì)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(yīng)逐步淘汰這些物質(zhì)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(yù)見，該禁令計劃將導(dǎo)致生產(chǎn)、供應(yīng)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(jīng)在為這些應(yīng)用密集尋找替代材料，因為對環(huán)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(huán)境中，切換到替代材料通常非常復(fù)雜。所需的歐盟/FDA材質(zhì)認(rèn)證，以及在某些情況下，醫(yī)療器械和/或醫(yī)藥產(chǎn)品本身的批準(zhǔn)，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(yīng)用進(jìn)行例外。可以肯定的是，這種批準(zhǔn)將授予醫(yī)療技術(shù)，制藥和生物技術(shù)領(lǐng)域的數(shù)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(jīng)尋求化學(xué)上沒有問題的替代品的證據(jù)。
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(zhì)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(fù)雜的國際供應(yīng)鏈...供應(yīng)鏈發(fā)生不可預(yù)見的中斷以及所有相關(guān)經(jīng)濟(jì)影響的風(fēng)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(zhì)進(jìn)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(yī)療技術(shù)領(lǐng)域的用戶 - 應(yīng)該解決這個問題，并考慮積極參與正在進(jìn)行的關(guān)于PFAS監(jiān)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(xué)品管理局（ECHA）已開始就REACH下PFAS的可能限制或禁令進(jìn)行磋商。在這里，受影響的團(tuán)體或協(xié)會可以為豁免法規(guī)收集論據(jù)。
