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How to Decide on the Most
Appropriate Regulatory Management
Option…
Helsinki Chemicals Forum 2019
…”The best option for
regulation is determined by
policy decision.”
…”Industry can make a
difference: informed
decision making leads to
better risk management.”
…”Maximum understanding
doesn’t imply optimum risk
management.” Fleur van Broekhuizen
RIVM/Bureau REACH
The Netherlands
What can we learn?
2
Uncertainties
play a key
role
Appropriate
RMO?:
Perspective
matters
There are
key
principles
Helsinki Chemicals Forum 2019
Different legislative options, e.g.
Helsinki Chemicals Forum 20193
REACH
OSH
Cosmetics
IED
BPR
PPPR
FCMD
Waste FD
Water FD
…
End-of-pipe
oriented
Source
oriented
EU / W-W
implementation
National
implementation
The NMP-case
4
REACH-Annex XIV
- SVHC (art.57c)
- Incentive for substitution
- Industry to apply for
authorization and show
safe use
- Case-by-case assessment
of safe use conditions
- Would address all uses of
NMP
REACH-Annex XVII
- 1 restriction versus many
applications for
authorization
- Targeted on the risks
observed
- Hazard is a threshold effect
- Safe use is possible
- Substitution did already
take place as far as possible
- Mandatory DNEL for
inhalation and dermal
exposure
- Prescribed safe use practice
- Alternatives are of
comparable concern
OSH
- Protection of worker health during
all process steps; also waste phase
- STOP-principle
- OELs for inhalation & Skin notation
- bOELs versus iOELS
Helsinki Chemicals Forum 2019
Helsinki Chemicals Forum 2019
…”The best option for
regulation is determined by
policy decision.”
…”Industry can make a
difference: informed
decision making leads to
better risk management.”
…”Maximum understanding
doesn’t imply optimum risk
management.”
…There is not just one way
to Rome and ideas about
the preferred way may
change with time
…Information on hazard,
exposure and uses is key
…In case of a (very) high
concern, precaution is an
important element of the
decision making process

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HCF 2019 Panel 1: Fleur van Broekhuizen

  • 1. How to Decide on the Most Appropriate Regulatory Management Option… Helsinki Chemicals Forum 2019 …”The best option for regulation is determined by policy decision.” …”Industry can make a difference: informed decision making leads to better risk management.” …”Maximum understanding doesn’t imply optimum risk management.” Fleur van Broekhuizen RIVM/Bureau REACH The Netherlands
  • 2. What can we learn? 2 Uncertainties play a key role Appropriate RMO?: Perspective matters There are key principles Helsinki Chemicals Forum 2019
  • 3. Different legislative options, e.g. Helsinki Chemicals Forum 20193 REACH OSH Cosmetics IED BPR PPPR FCMD Waste FD Water FD … End-of-pipe oriented Source oriented EU / W-W implementation National implementation
  • 4. The NMP-case 4 REACH-Annex XIV - SVHC (art.57c) - Incentive for substitution - Industry to apply for authorization and show safe use - Case-by-case assessment of safe use conditions - Would address all uses of NMP REACH-Annex XVII - 1 restriction versus many applications for authorization - Targeted on the risks observed - Hazard is a threshold effect - Safe use is possible - Substitution did already take place as far as possible - Mandatory DNEL for inhalation and dermal exposure - Prescribed safe use practice - Alternatives are of comparable concern OSH - Protection of worker health during all process steps; also waste phase - STOP-principle - OELs for inhalation & Skin notation - bOELs versus iOELS Helsinki Chemicals Forum 2019
  • 5. Helsinki Chemicals Forum 2019 …”The best option for regulation is determined by policy decision.” …”Industry can make a difference: informed decision making leads to better risk management.” …”Maximum understanding doesn’t imply optimum risk management.” …There is not just one way to Rome and ideas about the preferred way may change with time …Information on hazard, exposure and uses is key …In case of a (very) high concern, precaution is an important element of the decision making process