Cefic represents the chemical industry in Europe, with over 500 company members. It interacts daily with EU and international institutions on behalf of its members. The chemical industry invests 700 billion euros annually in R&D to develop new chemicals that improve performance, meet regulations, and anticipate customer needs. Substitution of chemicals is an innovation opportunity that requires a holistic assessment of technical performance, safety, and environmental properties to avoid regrettable substitution. Grouping chemicals can be useful for regulatory assessments if based on robust scientific criteria, but a one-size-fits-all approach should not be used, as substances within a group can have different hazard properties. The only way forward is through dialogue and cooperation between regulators and industry.

1. Grouping of Chemicals
and Substitution
Helsinki Chemical Forum 2019
2 3-05-19
Maggie Saykali – Cefic Specialty Chemicals

2. Page 2
Cefic: The voice of the chemical industry in
Europe
• Based in Brussels since 1972
• One of the largest industry trade
organizations in Europe and in the world
• 30 National Chemical Federations across
Europe
• Over 500 direct Company Members from
Europe,
• 40 Associate Companies from around the
world,
• 60 Partner Companies
• More than 20 Partner Associations
• Close cooperation with the other regions in
the world through ICCA.
We interact every day on
behalf of our members with
international and
EU institutions, non-
governmental
organisations, the
international media
and other stakeholders
Over 80 sector groups
are represented by Cefic in
three industry sectors:
Euro Chlor / Halogens,
Petrochemistry Europe,
Specialty Chemicals

3. Page 4
The Chemical Industry and innovation
The Chemical industry thrives on innovation and
develops new chemicals every day:
700 billion EUR are invested every year in R&D
• Improving performance and functionality
• Looking for better, safer and more affordable
substances
• Meeting the needs of customers
• Anticipating new regulations

4. Page 5
Substitution is an innovation opportunity
The challenge: Improve performance whilst ensuring
that any potential risks are assessed and managed.
Holistic assessment based on:
• Full LC Assessment
• Technical and process performance
• Safety data
• Health and environmental properties
• Fitness for use
• Availability and affordability of raw materials
This is needed to avoid regrettable substitution.

5. Page 6
Substitution and beyond
• The decision to substitute is for each company to
make on an individual basis, in compliance with
competition law.
• Substitution may need time to develop new
technologies and enable investment plans.
• Substitution can go beyond the product phase,
thinking about recycling and the re-use of waste.
• Substitution is not the only possible Risk
Management Option.

6. Page 7
Grouping of chemicals
• Can be a useful and efficient tool if based on robust
and justified scientific criteria.
• As a tool for registration of substances.
• As a first approach for regulatory assessments.

7. Page 8
Grouping of chemicals
For a thorough, in-depth assessment, a one-size-fits-all
approach to regulating chemicals as a class should not
be considered.
• Substances that have a similar basic structure can
have different tox/ecotox properties.
• A similar family name is not sufficient reason for
grouping.
• Widespread adoption of standard, validated
approaches will increase trust in the results.
• ECHA guidance on grouping and read-across is a
good basis on which to build.

8. Page 9
In conclusion
• Substitution is an innovation opportunity.
• Substitution is one of the RMOs available but there
can be others.
• Regulators can stimulate substitution.
• The grouping of chemicals for the purpose of
substitution has to be justified on the basis of
evidence.
• Results of RMOA of substitutes have to be accepted
by all stakeholders.

9. Page 10
The only way forward is through
dialogue and cooperation