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HCF 2019 Panel 1: Matti Vainio
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