1.230604 CAB BRETON2048 briefing REACH Final 2 Redacted.pdf

Ref. Ares(2023)7894824 - 20/11/2023

CAB BRETON/2048 - Breakfast meeting between Cefic
,
Cefic
and Commissioner Breton
26th of June 2023
o  Requesting  additional information requirements  during registration  to
identify more hazardous substances, like endocrine disruptors. It is key to
strike a balance between more information versus additional animal
tests and costs.
o  Requesting first, the notification of all polymers and, later, registration of
some groups of polymers. We are aware that this wil  be a big task for
companies but also for the European Chemicals Agency, so  we are
working to find a proportionate approach.
o  Introducing  a  Mixture Allocation Factor  to take into account the co-
exposure to different chemicals, but with some exemptions and a future
review to consider possible scientific developments.
o  Simplifying  authorisations  and  extending  the generic risk management
approach for restrictions. The implementation of these restrictions wil
be done in a staggered way according to a work plan.
o  Introducing the essential use concept, but complementary to the socio-
economic analysis for the specific assessment of risk.
o  Improving enforcement and compliance with REACH rules, especially for
imported products.

PFAS
•  Pol ution from PFAS (per-  and  polyfluoroalkyl substances) is a serious
human health and environmental concern. At the same time, some PFAS
are needed in critical applications, e.g. for the green and digital transition.

•  Five national authorities have proposed under REACH a broad ban (with
some derogations) on the use of PFAS. The Commission is waiting to receive
the opinion of the scientific Committees of the European Chemicals Agency
before proposing any legislative action under REACH.

•  However, the Commission envisages that derogations will be introduced for
critical uses where no alternatives are currently available, while
considering the need to minimise emissions of PFAS for the derogated uses.

•  The Commission wil  ensure consistency across different policy objectives,
such as reduction of chemical pol ution and the green and digital transition.

2

CAB BRETON/2048 - Breakfast meeting between Cefic

Cefic
and Commissioner Breton
26th of June 2023
Co-implementation – status quo

•  The co-implementation of the actions outlined in the Transition Pathway is
key to achieve the digital and green transition of the European Chemical
Industry and secure its competitiveness.

•  The first co-implementation meeting took place on 6th  March. We agreed
with stakeholders to work immediately on high priority topics for the twin
transition, such as addressing energy needs and circularity. We are already
working on these topics through dedicated task forces.

•  We plan to launch a call for transition initiatives this  summer to al ow
businesses, public administrations, and other organisations make
statements on what they are doing for a greener, climate-neutral, and more
digital chemical industry.

•  We encourage participation in the upcoming call for transition initiatives as
it is fundamental to understanding whether the Chemical Industry is
progressing towards its twin transition.

•  The next co-implementation meeting is on 22nd June. The upcoming call for
transition initiatives wil  be discussed during this meeting.

•  A third meeting is planned at the beginning of December.

•  In Q1 2024, we intend to publish an Annual Progress Report to outline what
we have achieved and what needs to be done to make the twin transition a
reality.

Member States’ role in the co-implementation and national transition plans

•  As outlined in the Pathway, Member States have a primary role to
implement the actions required to transform the Chemical Industry.  We
welcome CEFIC’s initiative to develop national transition plans as they can
support the twin transition of the Chemical Industry at national level.

•  We would like to continue our discussion with CEFIC to better understand
how national plans are currently developed.
3

CAB BRETON/2048 - Breakfast meeting between Cefic
,
Cefic
and Commissioner Breton
26th of June 2023
Questions to the interlocutor?

•  What is the state of play on CEFIC’s initiative to develop national transition plans?
•  what are the most critical changes in REACH for the EU chemical industry?
•  How can we ensure that the EU chemical industry remains competitive on the global
market?

Defensives

Q: In the current geopolitical and economic context, EU companies cannot
afford additional legislative requirements if they want to remain competitive.
A: The REACH revision wil  increase compliance costs for companies, but we are
working to make the new requirements as balanced and targeted as possible to
achieve an increased human health and environmental protection. EU
companies can remain competitive by investing in sustainable and innovative
solutions.

Q: How will the REACH revision simplify and reduce burden on companies?
A: Authorisations are one of the most complex procedures in REACH and have
created a lot of legal uncertainty for EU companies. With the REACH revision
we wil  make sure that the future authorisation system wil  be more
manageable and faster.

Q: Wil  the planned REACH revision disproportional y affect companies?
A:  We recognise that the REACH revision  wil   increase compliance costs for
companies, especially due to additional information requirements, notification
and  registration of polymers  and more restrictions based on the generic risk
management approach. At the same time, the REACH revision wil  bring
business opportunities for sustainable alternatives.

Q: How is the Commission ensuring that the registration of polymers take into
account the peculiarity of these materials?
A: We are aware that polymers are a special class of chemicals and registration
wil  be challenging due to the large number of polymers. For this reason, we
are discussing options for companies to notify all polymers and register some
polymers in groups, ensuring a proportionate approach.

Q:  Will  the generic risk management approach be disproportionately costly
and disadvantage European companies?
4

CAB BRETON/2048 - Breakfast meeting between Cefic
,
Cefic
and Commissioner Breton
26th of June 2023
A:  Restrictions based on the generic risk management approach wil  be
implemented in a staggered way through a work plan, to ensure predictability
and enough time to find alternatives.  We wil  prioritise  consumer uses and
focus only on professional uses with exposure patterns similar to those of
consumers. This is expected to al eviate impacts on companies.

Q: What will the Commission propose concerning the essential use concept?
A: We are preparing a Communication that provides guiding elements on the
implementation of the  essential use concept across different pieces of
legislation. When it comes to REACH, we are stil  discussing on how the concept
wil  be applied.  However, for the specific risk management, we envisage to
make the essential use concept complementary to socio-economic analysis.

Q: How the essential use concept can help simplifying authorisations and
restrictions?
A: We expect that the essential use concept wil  help reaching quicker decisions
on clear essential (e.g.  lithium batteries) and non-essential (e.g. plating of
lipstick case) uses.

Q: What wil  the Commission do to ensure proper enforcement of REACH?
A: We plan to improve the tools for customs authorities to enforce REACH, e.g.
by improving the access of customs authorities to chemicals databases. We
also  want to clarify responsibilities for compliance of products sold through
online platforms such as Amazon.  Finally, we  plan to revoke registration
numbers for dossiers that continue to be non-compliant.

Q: How are different workstreams of the Commission considered in the co-
implementation process?
A: We have already provided a roadmap with ongoing legislative initiatives for
the Chemical Industry in the Transition Pathway. We wil  continue to consider
different workstreams of the Commission on relevant legislative proposals in
the co-implementation process. We intend to present and discuss regulatory
updates for the Chemical Industry during the co-implementation meetings.
Q: What are the main chal enges of the co-implementation?
A: The Transition Pathway outlines an extremely broad set of actions (about
190) required for the twin transition of the chemical industry. These actions
need to be undertaken not only short term but until 2050. Continuous
col aboration and contributions from all stakeholders wil  be necessary to
achieve the twin transition of the European Chemical Industry. We are
5

CAB BRETON/2048 - Breakfast meeting between Cefic
,
Cefic
and Commissioner Breton
26th of June 2023
committed to ensure that al  stakeholders, including industry, Member States’
authorities, NGOs, academia and all interested parties are proactively
participating in the discussions on the co-implementation. Particularly, we
remark that the active involvement of Member States is fundamental to
ensuring the effective implementation of the actions laid out in the Pathway
over a long-time horizon.

Background
REACH revision
The REACH revision is planned in the Commission work programme for Q4 2023.
Some elements of the REACH revision are expected to lead to significant costs for
companies  (but also benefits in terms of increased human health and environmental
protection):
•  Additional information requirements, also on endocrine disruptors, during registration
– the main issue is to balance the benefits in terms of additional information required
with the costs for industry and additional animal testing.
•  New requirement to notify and register of groups of polymers  –  we do not know
exactly  how many polymers are on the EU market (best estimate: about 200,000).
Therefore, companies wil  need to first notify al  polymers. On that basis, the European
Chemicals Agency wil  define a methodology to group them. Registration wil  then need
to be done in groups and only for polymers that are expected to be more hazardous.
There is no agreement yet on how to do the registration step.
•  Inclusion of a Mixture Allocation Factor  to consider the combination effect of
chemicals. A low value would be proposed initially, with some exemptions (e.g.
applicable only to substances used above 1,000 tonnes per year) and with a review
clause to reassess the situation, also in light of possible new scientific evidence.
•  Extension of the Commission empowerment to restrict substances based on the generic
risk management approach.  Extension  to 1) additional hazard classes (e.g. endocrine
disruptors)  and 2) to certain professional uses (in addition to consumer uses). The
implementation of new restrictions wil  be done gradual y and according to a work plan
to provide predictability and give time to companies to adapt.

Cefic position on the REACH revision
•  Additional information requirements: Cefic calls for a proportionate approach and for
more non-animal test methods (better for animal welfare and cheaper for companies).
•  Polymers: Cefic calls for a workable and proportionate approach for  registering
polymers that targets only those that have properties associated with a higher likelihood
of hazard in line with a global y accepted approach. They support a first notification step
and registration in groups.
•  Mixture Al ocation Factor: Cefic expects that it will have an impact on the availability of
chemicals and suggests  having  a review clause to ensure that evolving scientific
evidence is taken into account.
6

CAB BRETON/2048 - Breakfast meeting between Cefic President Brudermueller,
Cefic Board members and Commissioner Breton
26th of June 2023
•  Generic risk management approach: Cefic supports a gradual implementation based on
a work plan and prioritising consumer uses with a high likelihood of exposure. They call
for a different approach to protect professional users, e.g. mandatory training and
certification schemes.
•  Essential use concept:  Cefic  considers that an essential use derogation process can
result in faster decision-making process and higher predictability (for clearly non-
essential uses), only if criteria are clearly defined and depending on how the procedure
is implemented.

PFAS restriction
PFAS are a group of thousands of mainly man-made chemicals that are extremely persistent
in the environment. They are widely used for their unique properties, e.g., stability under
intense heat, water and oil repel ence, across many industry sectors. In January 2023, five
national authorities  from the Netherlands, Germany, Denmark, Sweden  and Norway
submitted to the European Chemicals Agency a dossier to restrict PFAS under REACH. The
restriction dossier proposes to ban all PFAS, including the sub-category of fluoropolymers,
with  several  time-limited derogations (6.5 or 13.5 years).  Many consumer products (e.g.,
textiles, frying pans) but also critical applications in the digital (e.g. semiconductors) and
energy/mobility sectors (e.g. solar panels, lithium batteries) are affected by this restriction.

The proposed restriction is currently assessed by the European Chemicals Agency’s Scientific
Committees. This guarantees an independent scientific assessment on the risk reduction,
the availability of alternatives and socio-economic impacts of the restriction proposed. There
are  two stakeholders’ consultations  during this  stage  (the  first 6-month consultation is
ongoing until 25 September 2023). Based on the opinion of the Scientific Committees, the
Commission wil  consider an amendment to REACH to restrict PFAS, taking into account the
risks posed by the substances, the socio-economic impacts of the restriction and the
availability of alternatives. The Commission proposal will be discussed with Member States
in the REACH Committee. A decision on the PFAS restriction is not expected before 2025.

Cefic position on the PFAS restriction

Cefic  supports balanced regulatory measures on PFAS. Their main concern is that the
restriction proposal will lead to disruptions of value chains  and will eliminate key
applications in batteries, semi-conductors, electric vehicles and renewable energy
production. They are also worried that this restriction might hinder investments in these key
applications in the EU, as manufacturers wil  not invest if they know they wil  miss key
components in their value chains in the near future.

Transition Pathway for the Chemical Industry
In the Updated 2021 Industrial Strategy, the Commission proposed a series of transition
pathways to be co-developed with EU Member States, industry, and other stakeholders.
These pathways identify the actions needed to achieve the twin transition and increased
7

CAB BRETON/2048 - Breakfast meeting between Cefic
,
Cefic
and Commissioner Breton
26th of June 2023
resilience of industrial ecosystems.

In spring 2022, the Commission launched the co-development process for the Transition
Pathway for the European Chemical Industry. The Transition Pathway document was
published on 27 January 2023.

This document is structured on 8 chapters, so-called “building blocks”:
1.  Sustainable Competitiveness
2.  Investment and Funding
3.  Research and Innovation
4.  Regulation and Public Governance
5.  Access to Energy and Feedstock
6.  Infrastructure
7.  Skills
8.  Social Economy

The co-development process identified about 190 actions, needed for the twin transition
and increased resilience of the chemical sector. Such actions are clustered in 26 topics. In
turn, these topics are covered by the building blocks.

For each action the Transition Pathway indicates the timeframe (short, medium or long
term) and the actor that should perform that action (EU, MS and industry).

Finally, the Transition Pathway provides a roadmap composed of:
•  an action-oriented component focusing on actions needed to foster col aboration for
innovation, increase clean energy supply and feedstock diversification in the chemical
industry;
•  a technology component, covering the key technological contributors to the
transition pathway, such as electrification, hydrogen, biomass, waste, carbon capture
and utilisation and carbon capture and storage.
•  a regulatory component, collecting existing legislation and relevant research and
innovation initiatives influencing the twin transition of the chemical industry.

Transition initiatives
Transition initiatives are concrete actions undertaken by stakeholders (i.e. industry, NGOs or
national authorities) to contribute to the green and digital transition and increased resilience
of the Chemical Industry.
Transition initiatives should ideally include specific milestones and/or targets and a clear link
to the topics or broader objectives of the Transition Pathway.
Transition initiatives may be new actions but also be ongoing actions, and do not create a
legally binding obligation.

8

CAB BRETON/2048 - Breakfast meeting between Cefic
,
Cefic
and Commissioner Breton
26th of June 2023
Task forces
Following the first co-implementation meeting on 6th March, three task forces have been
established to work on specific actions of the Transition Pathway.
The first task force focuses on:
•  The development of KPIs and sustainable indicators to evaluate the twin transition.
•  How to ensure the development and commercialisation of safe and sustainable
chemical and materials.

The second task force analyses the energy and feedstock needs for the chemical sector. The
task force is currently gathering information and quantitative data on the energy and
feedstock needs for the Chemical Industry in 2030 and 2050. At a second stage, the task
force wil  assess what infrastructure needs to be developed today to al ow clean energy
supply and replace fossil fuels.

The third task force focuses on how to improve waste management and circularity in the
chemical sector.

It should be noted that the task forces have been established to accelerate the co-
implementation of actions that stakeholders considered as high priority.

In paral el, the other actions of the Pathway wil  be discussed during the plenary meetings
and will be considered in the call for transition initiatives.

9