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EU PFAS Restriction Proposal
Guidance on Creating Public
Consultations (Public Comments)

April 2023

Conference of Fluoro-Chemical Product Japan (FCJ)

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Disclaimer
The content and information contained in this material has been
compiled and translated from various sources and is solely theopinion of FCJ, which does not guarantee its contents. Pleasecheck the official information on the website of ECHA (European
Chemicals Agency), etc. for the latest information, as it is updated
as needed according to regulatory content and market trends.
Please note that we shall not be liable for any damages of any
kind incurred based on such information.
Copyrights and portrait rights to the content of this material are theproperty of their respective owners. Unauthorized reprinting,
duplication, sale, etc. of the information herein is strictly prohibited.
Please contact us you would like to reprint the information.

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Precautions on submitting opinions⚫

Scientific and socio-economic data must be presented.
Comments without supporting data are not considered important.

⚫

Please specify why a derogation is required along with objective data.

⚫

Confidential information must be attached to Section V.
The input information and attachments for Sections III and IV will be

published on the ECHA website.
⚫

It is not possible to save your submission and come back to it. Please
have your comments saved in some other format in advance.

⚫

It is not possible for you to retrieve your submission.
Please take a screenshot or printed copy, etc.

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Structure of the public consultation submission form
✓
✓
✓
✓
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Section I:
Section II:
Section III:
Section IV:
Section V:

Personal information
Organizational information
General comments and Questions 1-10 related to specific information (refer to the below)
Attachment of materials that can be published
Attachment of materials to be kept unpublished (confidential information)

Questions related to specific information in Section III (Questions 1-10)

✓
✓
✓
✓
✓
✓
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Question 1: (Final) product sectors and (sub-)uses (Reference: Table 9., from page 116 of the restriction
proposal)
Question 2: Emissions at each stage of manufacturing/use/disposal
Question 3: Questions related to incineration
Question 4: Impacts on the recycling industry
Question 5: Annual tonnage of PFAS and resulting emissions for proposed derogations
Question 6: Information on alternatives and socio-economic impact of uses missing from the restriction proposalor that have not been covered in detail.
Question 7: Information on alternatives and socio-economic impact of uses with derogation periods marked forreconsideration after the consultation.
Question 8: Information on alternatives and socio-economic impact of other identified uses.
Question 9: Degradation potential of specific PFAS sub-groups excluded from the restriction proposal (Item 1)(additional information)
Question 10: Request for information on analytical methods for PFAS
3©AGC Inc.

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Explanation of public consultation submission form
The site of a public consultation questionnaire entry form for the European Chemicals Agency’s (ECHA)PFAS restriction proposal
https://comments.echa.europa.eu/comments_cms/AnnexXVRestrictionDossier.aspx?RObjectId=0b0236e1885e69de (Click on link)

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Explanation of public consultation submission form

Compulsory fields/tick boxes are marked with an asterisk (*)

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Section I

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Personal information

Compulsory fields/tick boxes are marked with an asterisk (*)

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Section II

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Organisation
Input information on the organization/individual submitting public consultation (compulsory)

In the case of EU regulatory body /Country ↑In the case of individual
In the case organizations/institutions

Select whether to disclose the name of the organization/institution (compulsory)
Name of organization/institution may bedisclosed
Name of organization/institution to be kept
confidential
Compulsory fields/tick boxes are marked with an asterisk (*)

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8Section III ~ V Providing non-confidential/confidential information

Section III

List non-confidential information
not covered under specificinformation

List non-confidential
information onemissions/final disposal andalternatives/socio-economic
impacts, in particular, byproduct use/sector.
* Including uses/sectors not
mentioned in the restriction
proposal

Non-confidential comments
General Comments
Select the areas you wish tocomment on from the 10 areas
listed and limit your response to a
maximum of 9,000 characters.
Specific Information Requests
Select and respond the relevant
parts of Questions 1-10.

Section IV
Non-confidential attachment(Test data, business data, etc.)
Max 20MB

Section V
Confidential Attachment(Test data, business data, etc.)
Max 20MB*Please make sure that each piece of information is not repeated.

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Section III

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Non-confidential comments:General Comments
You must provide evidentiary
information in support of the opinion
you are submitting.
It is desirable to provide information
on socio-economic issues in thisconsultation. Specific examples
include, “Why is the part needed? /Why can’t other materials be
substituted? / What will happen if we
implement other materials?
(increased cost, increased
environmental and safety risks, etc.)/ What do the users say?” etc.
For general comments, please
select the check box for theitem(s) for which you would liketo provide an opinion.

Here you confirm that thegeneral comments do notinclude confidential information.
Please write your opinions here with a maximum of 9,000 characters.

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Section III Non-confidential comments:General Comments
FCJ believes that the proposal to collectively restrict all of the more than 10,000
organofluorine compounds (PFAS) as substances of concern on the same basis of
persistence as PFOS and PFOA, which are already regulated, is an excessive measure.
Therefore, the FCJ would like to propose the following comments in the Scope or Restriction
Option Analysis of General Comments of Consultation Section III.

⚫

Nonconformity of restriction proposal⚫

Exemption from restriction by PFAS subcategory (substance)

If you agree with the FCJ’s opinion on the Scope or Restriction Option Analysis of General
Comments in Section III, please indicate your endorsement of FCJ’s opinion and attach the
document linked below to Section IV.

FCJ Comment on PFAS

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Section III Non-confidential comments:General Comments
Please refer to the following for an example of how to submit the FCJ opinion document.
https://comments.echa.europa.eu/comments_cms/AnnexXVRestrictionDossier.aspx?RObjectId=0b0236e1885e69de (Click on link)

Step (1) List comments in Section III.
[Sample wording]**** (your company name) supports the statement
made by FCJ on the issues of proposed
restriction, as per attached in Section IV.

Step (2) Attach a Word document in Section IV.

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Overview of information to be provided in Section III
Section III: General comments
Specific information (Questions 1-10)

Lifecycle

Manufacturing/processing

Products

DisposalRaw materials/
components

Equipment/
facilities

Functions/benefits

Alternatives

What PFAS-containing
raw materials/components
are you using?
List the sectors and (sub-)uses of final products in
Question 1.

Are PFAS used inequipment and facilities?
(e.g., lubricants) List
sectors and (sub-) uses in
Question 1.

What are the functions andbenefits of PFAS in the
product? Why is it
important? (Importance of
PFAS in achieving therequired standard)

Why are there no PFAS
alternatives? (e.g.,
availability of alternatives,
performance trade-off
information, etc.)
List in Question 6-8

Some things to think about...
• What emissions are there at the manufacturing
stage?
(e.g., release to the atmosphere (outside
factories), volatilization/exposure to employees(inside factories), discharge into water, residue inproducts, etc.)
List in Question 2 or Question 5• Are these well-controlled?
Question 2• What risks or hazards are there from working
with PFAS? (e.g. worker safety/health)
List in general comments (Hazard or exposure)

List in Question 6-8
What is the lifetime of yourproduct?
List in Question 6-8

Some things to think about...
• What emissions are there during the use stage?
List in Question 2 or Question 5• Results of product degradation tests (e.g.,under high temperatures/in contact with strong
chemicals/in contact with water, etc.)
List in Question 6-8• For products that need to meet any EUinternational standard, name of the standard
and information on the testing process required
to meet the standard.
List in Question 6-8

Disposal
methodWhat are the options for
disposal method? (e.g.,
landfill, incineration).
Question 3
Do you have data on
emissions that are
generated if e.g. landfilled
or incinerated? List in
Question 2 or Question 5

Some things to think about...
• Do you know the disposal method for yourproducts?
List in Question 3• Do you receive from your supplier, or do you
provide guidance to your customers on correct
disposal method? List in Question 3• Do you know if your product can be recycled?
List in Question 3

If the content differs from the purpose of each question, please attach materials to
Section IV (non-confidential information) or Section V (confidential information).
*Prepared by FCJ from information contained in “Guidance on how to respond to the PFAS REACH restriction public consultation” compiled by the Fluoropolymers Product Group of Plastics Europe.

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13Regarding each question in Section III - 1: Sectors and (sub-)uses

List the sectors and (sub-)uses of (final) products containing PFAS. (e.g., aviation, electronics, food contact, etc.).
List with reference to Table 9., from page 116 of the restriction proposal.
If there are several sectors and (sub-)uses, list all of them
If there is no applicable sector or (sub-)use in Table 9, list the relevant sectors or (sub-)uses by specifying that it isomitted from the restriction proposal.

Link to Table 9 in the restriction proposal
https://echa.europa.eu/documents/10162/1c480180-ece9-1bdd-1eb8-0f3f8e7c0c49#page=136(Click on link)

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Question 2: Emissions at each stage of manufacturing/use/disposal

For each (sub-)use, we recommend that you submit the following information along with supporting data:(Excluding confidential information)• Annual emissions at each stage of the life cycle (manufacturing, use and disposal)*(e.g., release to the atmosphere (outside factories), volatilization/exposure to employees (inside factories),discharge into water, residue in products, etc.)• Information on the ratio of disposal through incineration, landfilling and recycling (as well as information on the formof recycling referred to).
*Please note that you are being asked for information on manufacturing, use, and disposal in the EU region.

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Question 3: Questions related to incineration

It is recommended that any additional information on the incineration of hazardous and general waste underordinary operating conditions that is useful for PFAS destruction and emissions prevention be submitted withsupporting data. (Excluding confidential information)

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4: Impacts on the recycling industry

Impacts on the recycling industry in the EU region*.
It is recommended that the following information be submitted along with supporting data. (Excluding confidential
information)a. The impacts that the concentration limits (25ppb, 250ppb, 50ppm) in paragraph 2 of the restriction proposal haveon the technical and economic feasibility of recycling processes.
b. Measures needed to achieve the proposed concentration limits.
c. The costs associated with these measures.
*Recycling companies in the EU region are in scope for this question.

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5: Proposed derogations – Tonnage and emissions

Indicate the annual quantity of PFAS used and released to the environment in applications
that fall under the derogation in Sections 5 and 6 of the restriction proposal. (Excluding
confidential information)(e.g., release to the atmosphere (outside factories), volatilization/exposure to employees(inside factories), discharge into water, residue in products, etc.)
In such cases, it is necessary to demonstrate the relevance of the data as representative data
for the relevant use.

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Questions 6-8: Listing of information on socio-economics and alternatives
by use18

 The sector of use for which information is provided will be answered in one of the Questions 6-8, depending on thestatus of the wording in the restriction proposal.
 In Questions 6-8, you are requested to provide information for the following seven items a-g.
 Please check the following pages for further details.

Item

Question 6
Uses not covered in the restriction
proposal (e.g., listed in Table A.1 inAnnex A)

Question 7
Uses for which derogation periods
were mentioned in square brackets in
the restriction proposal

Question 8
Other uses mentioned in the
restriction proposalaType of PFAS and annual tonnage and emissions associated with the relevant useb

The key functionalities provided by PFAS for the relevant use.

c

The number of companies in the sector estimated to be affected by the restriction.

d

The availability, technical and economic feasibility, hazards and risks of alternatives for the relevant use.

e

For cases in which alternatives are not yet available, the status of R&D, time/financial planning and the time required for
substitution, etc.

f

For cases in which substitution is technically and economically feasible but more time is required to substitute, the impacts on costs
and products, etc.

g

For cases in which substitution is not technically or economically feasible, the socio-economic impacts on companies andconsumers, etc. Sales, etc. in the EU for the related sector

For alternatives, please first list availability, etc. in d, and then add details including socio-economics in e-g as
applicable.

* In addition, please provide supporting scientific/socio-economic data/information.

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Question 6: Alternatives for uses not covered in detail or missing uses (a-c)

We recommend submitting information a-g below, along with supporting data for those uses not covered in detail in the
restriction proposal (uses highlighted in blue and orange in Table A.1 of Annex A) and for alternatives to the missing
uses. (Excluding confidential information)a. Type of PFAS and annual tonnage and emissions associated with the relevant use
b. The key functionalities provided by PFAS for the relevant use.
c. The number of companies in the sector estimated to be affected by the restriction.

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Question 6: Alternatives for uses not covered in detail or missing uses (d-e)

d. The availability, technical and economic feasibility, hazards and risks of alternatives. This includes information on
the extent (in terms of market shares) to which alternative-based products are already offered on the EU market andwhether any shortages in the supply of relevant alternatives are expected.
e. For cases in which alternatives are not yet available, information on the status of R&D processes (including
likelihood of successful completion, term/financial planning, and the time required for substitution (including
certification or regulatory approvals) and the major challenges encountered with alternative candidates studied in
the past).

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Question 6: Alternatives for uses not covered in detail or missing uses (f-g)

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f. For cases in which substitution is technically and economically feasible but more time is required to substitute.
i) The type and magnitude of costs (at company level and, if available, at sector level)ii) Time required for completing the substitution process (including any relevant certification or regulatory approvals)iii) Possible differences in functionality and the consequences for downstream users and consumers (e.g. estimationsof expected early replacement needs)iv) Benefits for alternative providers
g. For cases in which substitution is not technically or economically feasible, information on what the socio-economic
impacts would be for companies, consumers, and other affected actors.
If available, provide the value of EU sales and profits and employment numbers for the sector.

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7: Potential derogations marked for reconsideration – Analysis of alternatives andsocio-economic analysis:

The uses indicated with [square brackets] in paragraphs 5 and 6 of the restriction proposal are uses of PFAS where theevidence underlying the assessment of the substitution potential was weak* as a basis for substitution and socioeconomic impact analysis, and a derogation period will be reconsidered after the consultation. It is recommended thatspecific information (clearly stating the reasons for non-substitutability (e.g., functionality/longevity/cost) and supporting
comparative evidence be submitted, including the elements listed under a-g in Question 6 to strengthen the rationale
for the derogation period. (Excluding confidential information)*Please refer to Table 8 of the restriction proposal. Further details can be found in the sections of Annex E.
https://echa.europa.eu/documents/10162/1c480180-ece9-1bdd-1eb8-0f3f8e7c0c49#page=101 (Click on link)

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8: Other identified uses – Analysis of alternatives and socio-economic analysis

For many of applications, the evidence/information on alternatives is only in general terms, and much of it is qualitative*(especially some yellow-highlighted areas are inconclusive). Therefore, we recommend that you clearly state specificinformation (reasons for non-substitutability (functionality/longevity/cost, etc.)) that includes the elements listed in a-g ofQuestion 6 and provide supporting evidence. (Excluding confidential information)*Please refer to Table 8 of the restriction proposal. Further details can be found in the sections of Annex E.
https://echa.europa.eu/documents/10162/1c480180-ece9-1bdd-1eb8-0f3f8e7c0c49#page=101 (Click on link)

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9: Degradation potential of specific PFAS sub-groups

Please consider submitting any additional information you may have regarding the degradation potential of certain subgroups excluded from the restriction in Column 1 of the restriction proposal. (Information on potential degradation
pathways, kinetics or produced metabolites in relevant environmental conditions and compartments fortrifluoromethoxy, trifluoromethylamino- and difluoromethanedioxy-derivatives.)

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10: Analytical methods

Annex E of the restriction proposal contains an assessment of the availability of analytical methods for PFAS. Those
who have new or additional information on new developments in analytics not considered in the restriction proposal,
please consider submitting them.

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Section IV

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Non-confidential attachment

If needed, attach additional non-confidential information (excel data, test reports, etc.).
Do not attach the same information already provided in Section III here.
If you would like to submit more than one document, please create a compressed archive and upload it (maximum filesize is 20MB).
If part of the information is confidential, please attach in Section V, not Section IV.

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Section V

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Confidential Attachment

If needed, attach confidential information (studies and test data, business information, etc.).
Write reasons for confidentiality in the yellow highlighted field.
(However, please do not include any confidential information in the comment field.)
Do not attach the same information already provided in the Section III and IV here.
If you would like to submit more than one document, please create a compressed archive and upload it(maximum file size is 20MB).

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Specific case example (1) Semiconductor manufacturing process uses forwhich the derogation is reconsidered
Item Number

Classification

Applications and products

Duration ofderogation

Semiconductors

Semiconductor manufacturing process

12 years

28[Concept]
Semiconductor manufacturing process uses are uses for which the derogation period will be reconsidered after the consultation period, so enter
your comments in Question 7.
Due to the broad scope of the subject, specific uses are identified as much as possible, and information on material comparisons for eachperformance requirement is provided.
Indicate that there is no alternative, request an exemption, or indicate specifically that a minimum of 12 years is required as a substitution period
including certification and approval. (Input the information according to the sub-items a. through g. specified in Questions 6-8)
[Examples of Public Consultations]a. (compound name) is used for the  application in the  process of the semiconductor manufacturing process. Annual tonnage and emissions are  tons each.
b.  is adopted as the only component that simultaneously satisfies the required performance properties of , XX, and  in the relevant process.
The above required performance is directly related to the yield of semiconductor manufacturing and the  and XX performance of products, and is an extremely importantcomponent for the semiconductor industry.
c. It is estimated that approximately  companies in the semiconductor manufacturing sector will be affected by the unavailability of .
d.  is an alternative-based product already offered on the EU market with a market share of XX%. However, this is an incomplete alternative that can only be applied forsome processes in this use due to its inferior alkali resistance under high-temperature conditions compared to . Comparative evaluation data of  and  for this use isshown (detailed data is attached in Section IV (or Section V)). As conditions for a complete alternative for , it is essential that the strength at xxC be at least N/mm2
and the weight reduction to 40% NaOH be less than %, but there is no alternative available on the market with such performance other than the PFAS  currently in use.
e. As for alternatives, several candidate substances such as  and XX are under consideration. Development of an alternative candidate (Year , budget  million yen),commercialization study (Year , budget:  million yen), and application for certification and approval (Year , budget  million yen) are expected to take a total of XX
years, or over 12 years. No technically or economically feasible alternative candidate substance has been found among the type under consideration, and the likelihood of
successful development is expected to be quite low. The results of a current study indicate that Substance A costs 10 times more and does not have the required 
performance, while Substance B has the same cost but does not have the required XX performance. No substance has been found that simultaneously satisfies all threerequired properties and cost requirements. (Attach detailed data in Section IV (or Section V)). Another issue is that the replacement frequency will be  to X times more
frequent because the alternative candidate will have a product life that is  to XX% of the existing substance. In addition, the restriction should not be applied from theperspective of waste reduction because the waste volume will increase  times from the current  tons.
f. At this point, there is no prospect of technological or economic alternatives.
g. Socio-economic impacts on companies, consumers, and other actors are expected to be , xx, etc. In addition, sales, profits and employment in the EU in thesemiconductor-related sector were  million yen,  million yen and people (For confidential information, attach materials in Section V).
Based on the above, PFAS alternatives should be exempted from this restriction proposal, rather than a 12-year derogation period, because it is extremely likely that they will
not be a complete substitute and are, for all practical purposes, irreplaceable.

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Specific case example (2) Lubricant uses for which a 12-year derogation is
proposed
Item Number

Classification

LubricantsApplications and products
Lubricants used under extreme conditions or required for safe functioning
and equipment safety

Duration ofderogation
12 years[Concept]
With respect to the uses covered under derogation, Question 5 asks only for annual tonnage and emissions,which is inappropriate as an input point for discussing the availability of alternatives. In this example, the appeal
is for an exemption, not a 12-year derogation, so select “Exemption” in Section III, General Comments, and enter
your comments, or enter your comments in Question 8 (Other identified uses). (Input the information according to
the sub-items a. through g. specified in Questions 6-8)

[Examples of Public Consultations]a. Lubricant OO (compound name) is used for  application of  products. Annual tonnage and emissions are  tons each.
b.  is adopted as the only component that simultaneously satisfies the required performance properties of , XX, and  in the relevant use.
 is an essential component for the  performance of the  product.
c. It is estimated that approximately  companies in the  sector will be affected by the unavailability of .
d. Annex E.2.14.2.3 lists PCTFE although there is no conclusive evidence for the existence of alternatives. PCTFE still cannot be an alternative for
PFPE because it falls under PFAS and is inconsistent with the restriction proposal itself.
Similarly, fluorosilicones were mentioned as an alternative. Fluorosilicones need to be specified, but what can be defined as non-PFAS is limited.
Inconsistent with the proposed limit itself?
e. Present comparative evaluation data for specific PFPEs in actual use and non-PFAS fluorosilicone oils studied in the past for different uses. • • •(See Annex A.3.15.1 for thermal stability, nonflammability, radiation resistance, etc. in the operating temperature range, and attach detailed data, if
available, in Section IV (or Section V)).
f. At this point, there is no prospect of technological or economic alternatives.
g. Socio-economic impacts on companies, consumers, and other actors are expected to be , xx, etc. In addition, sales, profits and employment in
the EU in the related sector were  million yen,  million yen and  people (For confidential information, attach materials in Section V).
Based on the above, the candidate alternative technologies/substances listed in Annex E.2.14.2.3 are not substituted due to being PFAS. In
addition, non-PFAS fluorosilicones, which have been compared in the past, are not substitutable for practical purposes. Therefore, the proposed
12-year period is also not appropriate, and lubricants should be exempted from the restriction proposal.

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Reference: Location of consultations already submitted
As explained previously, submitted consultations will be published by ECHA on
a regular basis (non-confidential information only) at the following link.

Please refer to the submissions to date, which have already been published.
https://echa.europa.eu/restrictions-under-consideration/-/substance-rev/72301/term

A file summarizing the submitted
consultations is uploaded here.

Reference: Link to the above comments submitted to date (Word file): Number 3834-3871 (some numbers are missing)https://echa.europa.eu/documents/10162/23bc6cb4-4d81-cb8e-d3b9-c3d458c25f81

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About the FCJ
Name of organization:

Conference of Fluoro-Chemical Product Japan(FCJ)
Established: March 6, 2021

Established to provide appropriate information dissemination, advocacy
activities, etc. as fluorochemical manufacturers.
Business Profile (Excerpt)
 Research on environmental regulation trends, etc. for fluorochemicals
 Collaboration and coordination with domestic and international organizations
 Making recommendations to the government or related organizations
Activities to date (excerpted)
 Information-sharing and exchange on PFAS to related industry associations
 Providing input on proposed chemical evaluation methods (essential use and PMT/ED definitions)(In collaboration with JCIA) Recommendations on PFAS to the EU-Japan Business Round Table (EU-Japan recommendations) Collaboration with overseas chemical industry organizations
Participating companies (as of March 2023)
AGC Inc., Kitamura Limited, Kureha Corporation, Chemours Kabushiki Kaisha, Central Glass Co., Ltd., Daikin Industries, Ltd., DIC
Corporation, Tosoh Finechem Corporation, Chemours-Mitsui Fluoroproducts Co., Ltd.
Reference: “FCJ” Conference of Fluoro-Chemical Product Japan (cfcpj.jp); https://cfcpj.jp/

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Reference materials: From the 3rd FCJ webinar

What are public consultations in the REACH restriction process?
A public consultation (public comments) can be submitted by any individual, company, or organization.
The public comments and opinions of the European Chemicals Agency (ECHA)’s two committees will becompiled to form the restriction proposal.
Phase 1: Preparation and submission of therestriction proposal
Restriction proposals are prepared by the
proposing countries and submitted to theEuropean Chemicals Agency (ECHA)
ECHA confirms the contents.

Phase 2: Consultation and deliberations
Deliberations at ECHA will be carried out
in parallel with the consultations.

Phase 3 Legal decision andpreparation of restriction
A period of preparation before thecontent of the legislation is decided
and restriction begins.

2A) Gathering of opinions (consultation)
Starting the REACH restriction process

Consultations
Consultations regarding theregarding the SEAC
restriction proposal
proposalMarch 22 - September 22, 2023
(April 5: Briefing on consultations)Registration of intention tosubmit a restriction proposal
July 15, 2021
Preparation of
restriction proposal
Submission of
restriction proposal
January 13, 2023 (Submitted)

Opinion development
by RAC (Committee of Risk
Advice fromthe Forum

February 7, 2023 (Pre-publication)
After conformity check
March 22, 2023 (Official publication expected)

Progress in PFAS restriction

Assessment )EC decision The timeon restriction forindustries
proposal
to comply
with therestriction

Opinion development
by SEAC (Committee ofB) Deliberations by experts Socio-Economic Analysis)

Reference : https://echa.europa.eu/restriction-process*Please access the link below if you would like to view the 3rd FCJ webinar materials.
https://cfcpj.jp/pdf/No3_webiner_Document-20230407.pdf

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Reference materials: From the 3rd FCJ webinar

What are public consultations in the REACH restriction process?
We recommend that the first round of consultations be submitted by June, when both committees begin their discussions.

Regarding the timing of the submission, this information had not been released to the public
Phase 2 A Gathering of opinions (consultation)
Phase 2(B): Deliberations by experts
and is corrected as follows.

Committee
Convocation
timingRisk Assessment Committee(RAC)

Committee for Socio-economic Analysis

March 2023: Start of consultations regarding
restriction proposal(SEAC)• No primary deadline has been set this time.

Items to be provided by two months after
the start of consultations (mid-May)• Cost impact• Evaluation of alternatives

Reference :•https://echa.europa.eu/restrictions-under-consideration/-/substance-rev/72301/term
Verifying the scope of restriction• Verifying the scope of restriction
2023
June

proposal• Hazard conclusions and preliminary
discussion of exposure/risk

proposal• Preliminary discussion of theconclusions and benefits of thecost impact of the proposal on theindustry• As mentioned in the April 5 ECHA briefing, comments submitted by the deadline will be
Items to be provided by four months after
treated equally.
the start of consultations (mid-July)• Benefits/disadvantages of restriction• Request for exemption

Reference :•https://www.youtube.com/watch?v=JzZRtmaJeoQ
Conclusions on exposure/risk• Conclusions on the benefits of
September• Preliminary discussion on
exemptions

restriction• Preliminary discussion on
exemptions• Conclusions on exemptions• Decision on the written arguments
and statement of reasons, andadoption of the final opinion.

• Agreement on exemptions• Decision on written arguments andstatement of reasons andagreement on SEAC draft proposal• At this briefing, there were repeated comments that evidence is important.

September 2023
Final deadline for consultations on restriction
proposal• Some comments requested an earlier submission in general.

November

Therefore, we recommend that you
submitof SEAC
your consultation as soon as possible after the• Publication
draft proposal
evidence is available.
Start of consultations regarding the SEAC draft proposal
Not applicable

Discussion of the issues presented
in the consultations on the SEAC
draft proposal and adoption of final
opinion(Second consultation)

https://echa.europa.eu/documents/10162/9cb3c4f8-c2d9-c1dd-9a91-65dbb020f95a
Reference: Meetings of the RAC - ECHA (europa.eu);
https://echa.europa.eu/meetings-of-the-rac/2023

Meetings of the SEAC - ECHA (europa.eu);
https://echa.europa.eu/about-us/who-we-are/committee-for-socio-economic-analysis/meetings-of-the-seac/2023

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Reference materials: From the 3rd FCJ webinar

What are public consultations in the REACH restriction process?
 Submitted consultations will be:
used in the deliberations of the Committee of Risk Assessment (RAC) and the Committee of SocioEconomic Analysis (SEAC), which are expert committees of ECHA (European Chemicals Agency). Bothcommittees will develop their opinions as ECHA based on the restriction proposal and theconsultations received.
Committee of Risk Assessment (RAC): Consolidates opinions on whether the restriction proposal isappropriate to reduce risks to human health and the environment
Committee of Socio-Economic Analysis (SEAC): Consolidates opinions on the socio-economic impacts
associated with the proposal, i.e., benefits and costs tosocietyConsultations and committees’
responses to consultations
Risk Assessment Committee
opinions
Committee for SocioEconomic Analysis opinions

Consultations on theCommittee for SocioEconomic Analysis proposal

PFHxA case example Reference: Registry of restriction intentions until outcome - ECHA (europa.eu) ;https://echa.europa.eu/de/registry-of-restriction-intentions/-/dislist/details/0b0236e18323a25d

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Reference materials: From the 3rd FCJ webinar

What are public consultations in the REACH restriction process?
 Risks of not submitting consultations
Generally, it is said that not providing an opinion is an admission by the individualcompany/organization that they accept the restriction proposal. (Alternatives, rebuttal to derogation
periods, and description of uses not listed are required)
In some cases, they may also ask for individual opinions from those who submit consultations, whichmeans that they will not be on the negotiating table. Therefore, it is important to have written

arguments from both the individual companies and the industry organizations.
 Examples of successful consultations so far
As for the restrictions on PFOA and C9-14, the opinions of industry have been adopted andexemptions have been obtained for each.
*Detailed information is provided as a basis for submitting a written opinion.