2nd submission - Comment on Proposed Restriction of PFAS
Conference of Fluoro-Chemical Product Japan (FCJ)
On behalf of chemical manufacturers, we, Conference of Fluoro-Chemical Product Japan(FCJ), have been working tirelessly to comply with national chemical regulations. We havesupported EU's ambitious attempts to reduce risks from hazardous substances and havesincerely responded to actual measures to meet the requirements of EU chemical regulations
such as REACH. However, we believe that the proposed restriction of PFAS (Per- andPolyfluoroalkyl substances) proposed by 5 European countries is an excessive measure
because it restricts more than 10,000 of organofluorine compounds (PFAS) on the groupingbasis that they are persistent as substances of concern equivalent to the already regulated
PFOS and PFOA.
In addition to our opinion submitted on 18 May, reference # 4149, we would like to submit
our opinion on the following matters:【Positioning of intermediates】
Intermediates (transported isolated intermediates) are used in strictly controlled conditions
under the current REACH to convert to target compounds. As the above proposed
restriction is unclear as to the positioning of intermediates, we hereby offer our opinions inthis proposal.
1. The importance of intermediates
Restriction does not apply for some uses under the proposed EU PFAS restriction, and 5
and 12 year grace periods for the application of restriction are being proposed for uses thatare both socio-economically important and difficult to substitute. That said, the proposed
restriction does not address the handling of intermediates required to produce PFAS
substances for these uses.
In order to use PFAS substances for exempted or deferred applications and apply them totheir social functions, it is essential to use the intermediates in manufacturing, even if theyfall under PFAS by definition. In addition, maintaining the production of PFAS and the usingof intermediates in Europe will not only facilitate securing a stable supply of exempted ordeferred substances in Europe, but also lead to the development of related industries andmaintain employment. We would like to emphasize these points and argue for the proper
positioning of intermediates in the proposed restriction.
2. Handling of intermediates in REACH
Under the REACH regulation, intermediates are defined as substances that aremanufactured and used for chemical processing in order to be transformed into anothersubstance, and are classified as either non-isolated intermediates, on-site isolated

intermediates, or transported isolated intermediates. Among these, non-isolated
intermediates are not applied to REACH (Article 2 of REACH). The registration
requirements for on-site isolated intermediates and transported isolated intermediates aredescribed in Articles 17 and 18 of REACH, respectively, and reduced registration is inoperation when they are used under strictly controlled conditions.
As can be seen from the above registration measures, intermediates are expected to behandled by appropriately skilled workers at controlled manufacturing sites and aresubstances for which environmental emissions and exposure risks can be controlled.
With regard to PFAS restriction, Article 68 of REACH states that on-site isolated
intermediates are not subject to the adoption of new restrictions on manufacture, use, orplacing on the market, or to the revision of existing restrictions in Annex XVII. On the otherhand, transported isolated intermediates are not exempt from the adoption of newrestrictions, and their positioning in the proposed restriction is unclear. Article 18(4) ofREACH provides specific strict conditions for the use of transported isolated intermediates,and on that basis, the previous restriction proposals for PFOA1) and PFHxA2) were bothconsidered to exempt transported isolated intermediates from the restrictions.
A similar approach should be considered with the proposed PFAS restriction.
3. Suggestions for countermeasures
Based on the socio-economic importance of the intermediates as described above andthe perspective of the risk of environmental impact, we propose the following regarding thepositioning of transported isolated intermediates in the proposed EU PFAS restriction:
Transported isolated intermediates used in the manufacture of substances involved in
exempted or deferred applications under the proposed PFAS restriction should be subject
to the same restriction treatment (exemption or deferral of restriction) as the substances
involved in exempted or deferred applications if subject to the control of Article 18(4).
4. Active substances in plant protection, biocidal products, and human and veterinary
medicinal products
From the Q&A responses3) to the webinar held on April 5, 2023, we recognized theintention of the authorities in the five countries that "the proposed derogation also cover all
preceding steps that are necessary to produce the product" with respect to these activesubstances.
We recognize and endorse that this would exempt intermediates, as well as raw
materials, solvents, catalysts, etc. used in their production, with respect to theaforementioned active substances.
【Concentration Limits under Paragraph (2) of the Proposed Restriction】
In the proposed Restriction, 25 ppb for 1 PFAS, 250 ppb in total, and 50 ppm for polymeric
PFAS are proposed as concentration limits for all PFAS except for polymeric PFASs.

However, the underlying risk is not clearly stated for each limit proposed. In the proposed
Restriction, the only common rationale for restriction of all PFASs is persistency. Therefore,
we believe concentration limits commensurate with the risk should be established.
As an example, PFOA is a compound regulated by EU-POPs due to bioaccumulation andtoxicological effects in addition to persistence. While the concentration limit for PFOA andits salts is 25 ppb, the limit for PFOA-related substances, defined as those that can convert
to PFOA, is 1,000 ppb.
Furthermore, for SVHCs such as PBT and vPvB that fall under the provisions of Article 57
REACH, the concentration limit as a criterion for providing data is set at 0.1%.
For pharmaceutical products, the IMPURITIES IN NEW DRUG SUBSTANCES Q3A (R2) 4),
which was established based on the agreement at the International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human Use in the US,
EU, and Japan, set the reporting threshold for impurities at 0.05% (when the maximum
dose is 2g/day or less) or 0.03% (when the maximum dose is over 2g/day). For highly toxic
impurities, a lower concentration limit may be set as appropriate.
Thus, other regulations appropriately set concentration limits according to risk level.
Therefore, in this proposed Restriction, PFASs with only persistence risk and PFASs withbioaccumulation and toxicological risks in addition to persistence risk should be consideredseparately, and appropriate thresholds should be set according to the risk level.
【Review of Period and Exemptions】
The proposed Restriction proposes grace periods of 5 or 12 years besides the 18-monthtransition period. The rationale is limited to an assumed assessment of the availability ofalternatives in the future EiF (at the time of publication in the Official Gazette) based onsome information provided in the CfE as of 2021, with no mention of a review provision incase such alternatives prove to be impractical. In the consultations that began on March
22, ECHA requested that information on the Evidence base be provided. After careful
investigation of these submitted opinions and information on the availability of alternatives,
an appropriate conversion time should be reestablished, taking into account the timerequired for demonstrations and evaluations. In addition, research and development willneed to be conducted in the future for applications where no alternative has been identified.
A framework should be considered to allow for a postponement of the transition period ifseveral essential functions/roles cannot be achieved within 12 years.
We also believe a process should be established to consider new exemptions fortechnologies and applications that are currently unknown and for which PFAS is recognized
as essential for social implementation. Without careful and periodic review provisions, trade
restrictions and other restrictions on PFASs used in a wide variety of fields and applications
will not only cause market disruption, but will also deny the use of technologies that willcontribute to the attainment of a European Green Deal in the future.

Reference:1) Report on the request to review a derogation request (entry 68 of Annex XVII to REACH)
https://echa.europa.eu/documents/10162/7268a482-33bb-3686-7fdc4a32f560394e#https://echa.europa.eu/documents/10162/dd905dfc-fb1e-42b1-f1a5a705bb487d442) ANNEX XV RESTRICTIONREPORT
https://echa.europa.eu/documents/10162/7268a482-33bb-3686-7fdc4a32f560394e#https://echa.europa.eu/documents/10162/dd905dfc-fb1e-42b1-f1a5a705bb487d443) Restriction of per- and polyfluoroalkyl substances (PFAS) under REACH, Questions andanswers
https://echa.europa.eu/-/restriction-of-per-and-polyfluoroalkyl-substances-pfass-underreach#:%7E:text=Download%20Q%26A%20%28part%20II%20%2D%20content%20of%20
the%20proposed%20restriction%294) ICH Q3A (R2) Impurities in new drug substances
https://www.ema.europa.eu/en/ich-q3a-r2-impurities-new-drug-substances-scientificguideline