Transcript 1. Precautionary Principle

Forsigtighedstilgang –
gevinst eller stopklods
Precautionary Principle
good or bad for innovation
Bjorn Gaarn Hansen
Head of Unit: Chemicals
Directorate: Green Economy
European Commission, DG Environment
Copenhagen, 20-11-2014
Contents
1.
2.
3.
4.
5.
Caution, Precaution and the Principle
Risk in Chemicals Legislation
Precaution in Chemicals Legislation
Innovation in Chemicals Legislation
Conclusions
1. Precautionary Principle
"The precautionary principle, which is essentially used by decisionmakers in the management of risk, should not be confused with the
element of caution that scientists apply in their assessment of
scientific data." Commission Communication (2000) 1 – final of 2.2.2000
- - Caution is used when interpreting information
- - Precaution is used when developing models to
predict impacts
- - The Precautionary Principle is implemented
when the uncertainties are higher than normal
1. Precautionary Principle
- Under Regulation (EC) 793/93 the precautionary
principle was invoked 4 times:
- - PentaBDPE: Led to restrictions
- - OctaBDPE:
Led to restrictions
- - DecaBDPE: Led to testing (debromination)
- - Bisphenol-A: Led to testing (3 gen study)
1. Precautionary Principle
- And applied using Regulation (EC) 793/93, the
GPSD and the EUs Scientific Committees:
- - Phthalates: Led to restriction
- No examples since 2007, when REACH entered
into force.
1. Precautionary Principle
"Assigning responsibility for producing scientific evidence is already a
common consequence [of implementing the Precautionary Principle].
Countries that impose a prior approval (marketing authorisation)
requirement on products that they deem dangerous a priori reverse
the burden of proving injury, by treating them as dangerous unless
and until businesses do the scientific work necessary to demonstrate
that they are safe." Commission Communication (2000) 1 – final of 2.2.2000
• - Authorisation (eg Biocides, PPP, REACH)
2. Risk in Chemicals Legislation
"EU Chemicals regulation is risk based"
BGH
Globally harmonised system for classification and
labeling:
- -> Hazard Statements invoke Precautionary
Statement, based on "if you know the hazard you
can better control the risks".
2. Risk in Chemicals Legislation
"Chemicals regulation is risk based" BGH
Phase out of PBTs:
- -> PBTs accumulate in eg marine sediments and
higher food chain species, which are places where
it is virtually impossible to clean up, AND will
eventually cause toxic effects. Exposures should
therefore be minimised.
2. Risk in Chemicals Legislation
"Chemicals regulation is risk based" BGH
Restrictions to Consumers of CMRs:
- ->REACH and its predecessor legislation ban
CMRs for consumer use above a certain
concentration limit, as it is very likely that some
of the 500.000.000 consumers in the EU will end
up being exposed to a too high dose.
3. Precaution in Chemicals Regulation
"Chemicals regulation implements a cautious approach and
precaution" BGH
Examples are:
• - "Reasonable worst case approach" in risk
assessment is based on precaution
• - Reversal of Burden of Proof in REACH
4. Innovation in Chemicals Regulation
• "Innovate: Make changes in something established, especially by
introducing new methods, ideas, or products." OXFORD DICTIONARY
• EEAs "Late Lessons, Early Warnings" give many
examples of how legislation, through bans of
specific chemicals, has stimulated innovation and
accelerated the development of safer
alternatives.
4. Innovation in Chemicals Regulation
• "Substitution of hazardous by less hazardous substances" Basic Principle in OSH
• But also the act of substituting something hazardous
by something less hazardous is innovation.
• This can be at
• - chemical design and development
• - chemical use, upstream and downstream
4. Innovation in Chemicals Regulation
• Substituting something hazardous by something
less hazardous reduces costs, as less risk
management is needed to ensure safe handling
and use, increases safety, as the risk potential is
reduced.
• Pre-requisites for an efficient substitution is:
• - fair chemicals market regarding hazard/risk
information
• - equal playing field between economic operators
Which is what
REACH does……..
4. Innovation in Chemicals
Regulation
• What differences between Precautionary Principle
cases and the general substitution, through
industry own activities or through restrictions,
affect innovation?
• - time from regulatory attention to regulatory
action?
• - predictability?
• - availability of alternatives?
4. Innovation in Chemicals Regulation
• The application of the Precautionary Principle is
part of the bigger drive for substitution, which
overall stimulates innovation.
•
•
•
•
What is needed is:
- Generally much better knowledge on chemicals
- Increase predictability of regulatory action
- Draw the lessons from the observation that
chemicals seldom get less hazardous with time.
4. Innovation in Chemicals Regulation
• 7th Environment Action Programme sets a longer
term plan for creating a better chemical
knowledge base
• We should all work to make REACH more
predictable, whilst meeting its aims
- REACH was intended to be faster, easier and
more efficient than past legislation.
Conclusions
• Current legislation is based on risk, builds in
caution and precaution and stimulates innovation
through its general pressure to control risks and
substitute.
• Within this 'big picture' the Precautionary
Principle plays a less prominent role – but does
contribute to stimulating innovation.
Thank you for your attention
Bjorn Hansen, Head of Unit, Chemicals,
DG Environment, European Commission, Brussels
http://ec.europa.eu/environment/chemicals