Comment on Proposed Restriction of PFAS
May 25, 2023
Japan Fluoropolymers Industry Association (JFIA)
We, Japan Fluoropolymers Industry Association (JFIA), think that fluoropolymers should bedistinguished from the proposed restriction of PFAS (Per- and polyfluoroalkyl substances), whichcollectively regulates more than 10,000 of organofluorine compounds (PFAS) on the grouping basis.
We believe fluoropolymers should be exempt from its restriction because they differ from other
PFASs in physical, chemical and toxicological properties.
We support the statement made by the Conference of Fluoro-Chemical Product Japan (FCJ) onthe issues of proposed restriction*1. In particular, we support the exclusion by PFAS subcategory withthe following views. Therefore, we request for exemption of fluoropolymers from the proposed ban
on EU market through ECHAʼs public consultation.
*1 Conference of Fluoro-Chemical Product Japan (FCJ). April 25, 2023. Comment on Proposed Restriction of PFAS:
https://cfcpj.jp/european-pfas-lp.html

１． Fluoropolymers in PFAS subcategory (substance)
Regarding the negative impact of PFAS on the environment, as shown Fig. 1, PFOS
(Perfluorooctane sulfonic acid) and PFOA (Perfluorooctanoic acid) were initially focused. Earlyconcerns have been also raised about non-C8 perfluoroalkane sulfonic acids (PFSAs) andperfluoroalkyl carboxylic acids (PFCAs). These substances can be classified as perfluoroalkyl acids(PFAAs) that are water-soluble. Some of PFAAs have already been regulated due to thebioaccumulation and toxicity of each substance. Fig. 2 shows the PFAS family as an example ofPFAS subcategory (substances).

PFSAs

C8C6C4C5,7,9,10PFCAs

C8C9C7C4-6, 10-14PFAAsFluoropolymers：PTFE、PFA、ETFE、FKM etc.
Sources: Interstate Technology & Regulatory Council (ITRC). 2022. PFAS Technical and Regulatory Guidance. P.37 Fig. 2-16

Fig. 1 Relation between fluoropolymers and emerging awareness on PFAS occurrence in the environment

PTFE, PFA, ETFE,FKM etc.
*Early Attention*Recent Attention

Sources: Interstate Technology & Regulatory Council (ITRC). 2022. PFAS Technical and Regulatory Guidance. P.20 Fig. 2-3

Fig. 2 the PFAS family
Next, fluorotelomers and perfluoroalkyl ether acids like higher-molecular-weight polyfluoroalkyl
substances have recently been raised as potential PFAAs due to their own degradability. Fig. 3 ofAttachment 1 shows PFAS family tree.
On the other hand, fluoropolymers are classified as one type of PFAS according to international
definition, but unlike other polyfluoroalkyl substances such as fluorotelomers, they belong to a class ofpolymers that are highly polymerized over 100,000 Da（Dalton: unified atomic mass unit）, and haveextremely high stability(persistency). Attached Fig. 3 indicates the potentiality of decomposition intoPFAA precursors reported by Buck et al. (2011) for each PFAS subcategory, but there is no indicationof the potentiality for the fluoropolymers subclass.
Fluoropolymers are thermally, chemically, photochemically, hydrolytically, oxidatively andbiologically stable, barely soluble in water, immobile, insoluble (Water, Octanol, etc.) and too large tomigrate to cell membranes. Therefore, they are not incorporated into the body and are considered low
concern from a human and environmental health perspective.

２. Exposure to fluoropolymers in workplace environment
For human inhalation, following occupational exposure to degradation products of fluoropolymer
PTFE (e.g. pyrolysis products) or particles (e.g. spray application), severe toxic effects are reported in
section 1.1.4.9 “Effects on human health” in the Annex XV report. However, the toxic lung effect ismatter of risk assessment in the working environment. Its countermeasures have openly been madeknown in the fluoropolymer handling guides issued by industry trade associations in major countries
since the 1970s*2, 3 and the effect on workers have been under control.
*2 Plastics Europe. June, 2021. Guide for the safe handling of fluoropolymer resins:
https://fluoropolymers.plasticseurope.org/index.php/fluoropolymers/irreplaceable-uses-1/reports-policydocuments/tfe-safe-handling-guide*3 Japan Fluoropolymers Industry Association (JFIA). February, 2021. Fluoropolymer handling manual:
http://www.jfia.gr.jp/handling.html

Attachment 1(8) High molecular weight polymericplastics such as PTFE
*Early Attention*Recent Attention

PFAA precursors

Sources: Interstate Technology & Regulatory Council (ITRC). 2022. PFAS Technical and Reuglatory Guidance. P. 21, Fig. 2-4.

Fig.3 PFAS family tree