Panel 1: How to choose the best possible risk management option to regulate substances of very high concern

1. Does REACH authorisation work?
Helsinki Chemicals Forum
Matti Vainio, Ph.D. (Econ)
Head of Risk Management Unit
European Chemicals Agency
23 May 2019

2. 2
Risks reduced
• 1/3 of companies improved risk management measures
• SVHC uses have become significantly safer
System costs ~€25m/year (for 50 applications/yr)
~1/3 on applications, 1/3 on risk control and 1/3 on decision making
Source: REACH Review of the Commission (2017)
How effective is authorisation to improve the handling of
SVHCs?

3. 3
How effective is it in triggering substitution?
 Almost ½ of
companies surveyed
(n=63) had
substituted
 Signalling works:
reaction to candidate
listing of a substance
“REACH Authorisation seems to be a major (but not the only) driver for
substitution” (Impacts of REACH Authorisation, European Commission 2017)

4. 4
Two examples
Murano Glass, IT
From arsenic
trioxide to cerium
oxide and ground
granulated blast
furnace slag.
European Project
From Cr(VI) to
“diamond-like-carbon”
coating of cylinders for
printing and packaging
Italian government funded research
leading to discovering of safer alternatives.
Substitution took place.
Arsenic concentrations in Murano air
dropped by 98 % (from 200 ng/m3 in
2014 to 4 ng/m3 in 2016).
Did not apply for authorisation.
Developed prototype system and enabled
technology owners to establish joint
ventures and licensing deals for wider
market uptake in 2019.
Source: Horizon 2020
https://cordis.europa.eu/project/rcn/206525/factsheet/en

5. What have we achieved with authorisation that we could not
have done with restrictions?
• Reverse the question?
• From MS point view: Quick action to reduce risks and to
substitute
• Information revealing on about uses and alternatives
• Who pays and for what?
• Implementation of 20 restrictions estimated to cost €290m/year
• System cost of applications for authorisation (43 substances) about
€25m/year
• State aid compatibility
• Finance (e.g. Horizon Europe) possible for authorisation

6. 6
Does REACH authorisation work?
Good functioning of the
internal market
Risks properly controlled
Substances progressively
replaced by suitable
alternatives
 System cost relatively low
– Improvements needed in
applications, predictability and
system efficiency
– Unknown/hidden costs?
 Risk reductions are often well
demonstrated
– Risks should be further reduced
 Substitution is taking place
‒ More could be done
Where we areObjective

7. 7
So why does authorisation have few friends?
• Over (?) ambitious expectations on
• what (upstream) applicants actually know about use and alternatives
• what information (effortlessly) passed up and down supply chain
• Legal text in not unambiguous
• What are technically or economically feasible alternatives?
• What are benefits for the applicants vs the society?
• Some think it is “easy” not to authorise
• Applications are made for a reason
• Asymmetric information
• “Similar” is not the same as “same”
• Authorisation system is still very new in its operation
• What is the right level of scrutiny?

8. Thank you!
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matti.vainio@echa.europa.eu