Document QJ6VokYXRjYbpQyVKGr6kmb18
Next steps and potential delays
The European Chemical Industry Council, AISBL - Rue Belliard, 40 - 1040 Brussels - Belgium Transparency Register n64879142323-90
Ref. Ares(2024)1718859 - 05/03/2024
Timelines and delays Comparison of 4 REACH restrictions RAC/SEAC opinion development (UPFAS)
Timelines and delays Comparison of 4 REACH restrictions RAC/SEAC opinion development (UPFAS)
The restriction proposal - restriction process: potential delays
2021-2023
Publication of the dossier
February 2023
RAC adopt final opinion/SEAC publishes draft opinion (DO)
ECHA sends compiled Commission draft opinions to COM proposal to WTO
6-month public consultation 22 Mar `23 - 25 Sep '23
60-day public consultation on
SEAC DO
Risk Assessment Committee (RAC) opinion development Socioeconomic AssesSsEmAeCnotpCionmiomn idtetevel(oSpEmACe)not pinion development
Commission draft proposal
REACH Committee
Adoption of the Commission Regulation
Scrutiny by EP & Council
Dossier Preparation
Development of the opinion in ECHA
Regulatory process*
Potential delays
*Commission regulation adopted by implementing acts
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The restriction proposal - potential delays and examples in other restrictions: microplastics, silicones and PFHxA
Publication of the RAC opinion
Proposed time in legislation: 9 months Delays: microplastics 7 months, PFHxA 8 months (no delay on silicones)
Publication of the SEAC opinion
Proposed time in legislation: 12+3 months Delays: microplastics 7 months, PFHxA 8 months (no delay on silicones)
Publication of Commission draft Regulation
Proposed time in legislation: 3 months after SEAC opinion or if no opinion by ECHA 15 months after publication Delays : microplastics 17 months PFHxA 15 months, silicones 36 months
Commission draft Regulation submitted to WTO for a decision on technical barrier
Proposed time in legislation: 60 days for writing comments No examples to date but huge international impact on the UPFAS restriction consultation with 29 non-EEA (including China and India) contributions.
REACH Committee's decision
Proposed time in legislation: time limits may be fixed by the chair Delays: microplastics 7 months, PFHxA 7 months to date
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The restriction proposal - timeline of other restrictions: microplastics, silicones and PFHxA
Standard time: total 2 years
12 + 3 months
3 months 3+3 months
ECHA publication of the dossier
ECHA Commission final opinion draft opinion
Adoption of The restriction
Microplastics: total 4,7 years (adopted)
ECHA 22 months
Silicones D4/D5/D6: total 4,4 (so far)
ECHA 13 months
PFHxA: total 3,4 (so far)
ECHA 23 months
Commission 20 months
REACH+Scrutiny 12 months
ADOPTED
Commission 39 months
Commission 18 months
REACH
7 months to date
REACH
5 months to date
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Timelines and delays Comparison of 4 REACH restrictions RAC/SEAC opinion development (UPFAS)
Comparison of U-PFAS/PFHxA/Microplastics and Silicones
Per- and polyfluoroalkyl
substances
Intentionally-added microplastic
Silicones D4/D5/D6
-Numbers of answer to the consultation
-Answers by country
-Missed uses
PFHxA its salts and related substances
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Per- and polyfluoroalkyl substances
5642 comments received 68.5% companies/industry/trade associations 27.3% individuals
Number of comments by type of consultee
Others 234 4,1%
Missed uses - references in the proposal The proposal distinguished between uses researched in detail, in
general and not researched in detail Many respondents answered the question on missed uses
Individuals 1543 27.3%
Industry or trade associations 552
Companies
Individuals
Companies 3313 58.7%
Industry or trade associations Others
53 countries commenting: 28 EEA - 25 non-EEA Comments from EEA vs rest of the world: 3835 vs 1806 Japan 938, China 262, US 191, India 8
* Source: ECHA, https://echa.europa.eu/-/echa-receives-5-600-comments-on-pfas-restriction-proposal
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Intentionally-added microplastic
477 comments received 69.2% companies/industry/trade associations 9.9% individuals
Number of comments by type of consultee
Companies 147 30.8%
Others 99 20.9%
Missed uses - references in the documents linked to the opinion development Not many additional uses reported (RCOM) 3 additional uses identified on the Background Document (BD):
Bulk IER (Ion exchange resins Microplastics used as toys or for Do It Yourself (DIY) Microplastics used as packing material for the transportation
of sheet glass
Individuals 47 9.9%
Others Individual
Industry or trade
associations 183 38.4%
Industry or trade association Company
27 countries: 20 EEA - 7 non-EEA Comments from EEA vs rest of the world: 395 vs 82 United States 14, Japan 8
* Source: ECHA, ddf89aed-5bb8-ebf3-48d4-b06134641179 (europa.eu)
Number of comments by country
Germany United Kindgdom
Italy Sweden
Spain Poland Denmark Czech Republic Norway Uruguay Slovenia New Zealand Hungary Australia
44 28 22 22 16 14 14 8 8 8 7 6 6 6 4 2 1 1 1 1 1 1 1 1 1
137 115
0 20 40 60 80 100 120 140 160
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Silicones D4/D5/D6
47 comments received 83% companies/industry/trade associations 8.5% individuals
Number of comments by type of consultee
Individuals 4 8.5%
Others 4 8.5%
Industry or trade
associations 20 43%
Companies 19 40%
Industry or trade association Company Individual Others
13 countries: 10 EEA - 3 non-EEA Comments from EEA vs rest of the world: 32 vs 15 United Kingdom 7, United States 4, Japan 2
Missed uses - references in the proposal Not many additional uses reported in the response to comments
prepared by the dossier submitter (RCOM) One additional use identified on the Background Document (BD)
and on the restriction proposal covering cleaning and restoration of art and antiquities
Number of comments by country
Belgium United Kingdom
France United States
Germany Poland Japan
Denmark Sweden Norway Netherlands
Italy Canada
0
2
4
6
8
10
12
14
16
18
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Undecafluorohexanoic acid (PFHxA), its salts and related substances
202 comments received 87% companies/industry/trade associations 2% individuals
Number of comments by type of consultee
Industry or trade
associations 56 28%
Missed uses - references in the documents linked to the opinion development Information note on the restriction report acknowledged that
stakeholders reported about additional uses during the consultation The final background document included a chapter on the additional uses and stated "The Dossier Submitter argues that there are most probably current (and future) uses not identified"
Companies 119 59%
Others 22 11%
Individuals 5 2%
Industry or trade association Others Individual Company
22 countries: 13 EEA - 9 non-EEA Comments from EEA vs rest of the world: 142 vs 60 United States 21, Japan 18
Number of comments by country
Number of comments by country
54
Belgium
30
21
Japan
18
14
Italy
13
8
Netherlands
8
7
Switzerland
5
4
Australia
4
3
Czech Republic
3
2
Austria
2
1
Taiwan 1
1
Slovakia 1
1
Croatia 1
0
10
20
30
40
50
60
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Timelines and delays Comparison of 4 REACH restrictions RAC/SEAC opinion development (UPFAS)
Main Characters during RAC/SEAC opinion development
Rapporteurs
RAC and SEAC members
Dossier submitters
Propose the draft opinions. Assess the comments received in the consultation and answer to them in the RCOM and ORCOM.
Comment on the draft opinions (small group can support more hands on).
Support the rapporteurs. Assess the comments received in the consultation and answer to them in the RCOM and ORCOM.
Revise the background document to include the comments, address the questions and recommendations by RAC and SEAC.
Commission
It is an observer. Provides comments on the different rounds of consultation.
Stakeholders
Regular stakeholders Occasional stakeholders
ECHA (Restriction team)
Administrative work as secretariat; Supports the Chairs, Committees and rapporteurs of RAC and SEAC and facilitates communication between them and the Dossier Submitter(s).
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RAC/SEAC opinion development- ECHA discussions key dates
SEAC-62 12-15 Mar Ski waxes, cosmetics & consumer mixtures
SEAC-63 03-07 Jun & 10-14 Jun
RAC-68 11-14 Mar Ski waxes, cosmetics &
consumer mixtures
RAC-69 03-07 Jun
Plenary meetings: discussions and decisions
SEAC-64 09-13 Sep & 16-20 Sep
SEAC-65 25-29 Nov & 02-05 Dec
SEAC .....
RAC opinion adopted/ SEAC publishes draft
opinion (DO)
RAC-70
RAC-71
RAC
16-20 Sep
25-29 Dec
.....
60-day public consultation on
SEAC DO
Development of the opinion in ECHA
ECHA sends compiled opinions to COM
RAC-68 REST WG 04 Mar
RAC-69 REST WG 27-28 May
RAC-70 REST WG 09-10 Sep
RAC-71 REST WG 06-07 Nov
RAC REST WG .....
Limited access to meetings: only accredited stakeholders can be invited to the meetings
RAC Restriction Working Group meetings: extensive discussions no decisions
* the background document is only publicly available following the publication of ECHA public opinions
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RAC/SEAC opinion development- documents publicly available
Publication of the dossier February 2023
6-month public consultation 22 Mar `23 - 25 Sep '23
Risk Assessment Committee opinion development Socioeconomic Assessment Committee opinion development Development of the opinion in ECHA
RAC opinion adopted/ SEAC publishes draft
opinion (DO)
60-day public consultation on
SEAC DO
ECHA sends compiled opinions to COM
Publication of responses to rePcuebilviceadtioonntohferCeospnosunlsteastitooncoonmSmEAenCtosptainbiloen
comments table (RCOM)
(ORCOM)
The rapporteurs (RAC & SEAC) will be proposing different draft opinions along the process that will not be publicly available
Dossier Submitters revise the background document*
* the background document is only publicly available following the publication of ECHA public opinions
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RAC/SEAC opinion development- knowns and unknowns
Some knowns:
Discussion in ECHA will be structured following a sector-by-sector approach. Next discussions: ski waxes, cosmetics & consumer mixtures
The rapporteurs (RAC & SEAC) will be proposing different draft opinions focusing on the different sectors where they can modify the restriction proposal in different ways i.e. adding or deleting derogations
Access to meetings by stakeholders is limited as ECHA needs to ensure balanced representation between social society and industry, and the number of stakeholders invited should not exceed half of the number of the appointed members
Access to nonpublic documents (i.e. draft opinions) by stakeholders is granted when stakeholders invited to the meetings
Some unknowns:
Next sectors to be discussed ( June onwards) Different draft opinions (nonpublic) to be proposed for every sector Full list of criteria used by ECHA when selecting stakeholders to be invited to the meetings and criteria to access
nonpublic document by occasional stakeholders
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Conclusions
Timelines
Significant delays to be expected during the process. U-PFAS restriction may take at least 4,7 years (microplastics).
Comparison with other REACH restrictions
U-PFAS restriction is unprecedented It received 12 times more contributions than the microplastics restriction. Worldwide impact of the U-PFAS restriction: non-EEA contributors triple other restrictions; contributions received from US, Japan, China and India. PFHxA only precedent with a number of missed uses not covered in the proposal. REACH Annex XV3 establishes that the proposal needs to assess the use of alternatives and the socio-economic impact of the restriction. Therefore, uses need to be identified.
RAC/SEAC opinion development
Unprecedented file; highly complex Innovative approaches may be adopted to be able to complete the process i.e sector by
sector approach Important to become an accredited stakeholder to be involved in the discussions
The information contained in this document is intended for general guidance only and does not constitute legal advice. The document may evolve as further information is collected and analysis carried out.
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