Transcript Substitution

Substitution/Comparative
Assessment
Vibeke Bernson PhD
Advisor to Director General in
International Affairs
Swedish Chemicals
Inspectorate
www.kemi.se
Substitution approaches
”Broad” substitution driven
by a Duty of Care
•
Starting point for ”voluntary”
product choices, less suitable for
legal enforcement
Substitution by restrictions
(authorisation or ban)
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Applied on a ”limited number of
substances
www.kemi.se
Drivers for Industry for
substitution
• Regulatory drivers
• Increased public awareness
• Demand from downstream
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users or clients
Liability issues
Insurance encouragement
incentives or requirement
Competitive advantages
Company ethics
www.kemi.se
Promoting use of the
substitution principle
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Phase-out timetables from
Government
List of substances ”to be
avoided”
List of ”good examples” to give
ideas
Dialogues with sectors
Public and private procurement
Ecolabel (Nordic Swan)
Green Chemistry/Eco Design
www.kemi.se
Complex process
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Assess and understand
magnitudes
Use functionality
Think broadly, by unconventional
thinking you may be able to solve
more than one problem at the
same time.
Taking the costs now may be
cheaper than in the future and
before you are forced to do so by
legal actions, alarm or customers
pressure
www.kemi.se
Results - companies
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Volvo
Electrolux
Ericsson
IKEA
H&M (Hennes & Mauritz)
Skanska
SMEs
www.kemi.se
Results - sectors
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Paints and lacquers (e.g. lead-,
tin- compounds)
Cleaning products, detergents
(e.g. NPE, LAS)
Construction (e.g. BFR,
phthalates)
Steel and metal (e.g. SCCP)
Textiles (import) (e.g. azodyes,
”heavy metals”)
Car care (e.g. VOC, NPE)
Tires (HA-oils)
www.kemi.se
Results – substances
Chlorinated paraffin's,
19995 - 2001
1400
tonnes
Chlorinated paraffin, C 10 - 13
1200
Chlorinated paraffin, C 14 - 17
Chlorinated paraffin w axes
1000
800
600
400
200
0
1995 1996 1997 1998 1999 2000 2001
www.kemi.se
Results - substances
Nonylphenol ethoxylates,
1993 - 2001
Number of
products/Tonnes
1600
1400
1200
1000
Number of products
800
Consumption, tonnes
600
400
200
0
1993 1994 1995 1996 1997 1998 1999 2000 2001
www.kemi.se
Comparison with substitution
forced by a ”ban” Trichloroethylene
Applicant for exemption has to
show that:
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Alternatives are continuously searched
for
No useable alternative available at
present
Use do not comprise an unacceptable
exposure
European Court of Justice: Exemption
criteria in line with substitution principle
already in European law
(c.f. authorisation criteria proposed in
REACH by Sweden)
www.kemi.se
Findings and conclusions
(1)
”Duty of Care” part I
Screen substitution possibilities when…
• Buying/developing chemicals/articles
• Screening processes/products of other
reasons
• Getting demands from customers
Consider substitution if…
• Chemical with highly dangerous properties
• Clearly less dangerous chemicals
available,
or alternative
process/material/construction
• Functional alternative, reasonable costs
www.kemi.se
Findings and conclusions
(2)
”Duty of Care” part I
Substitution may lead to …
(benefits)
• Innovation/evolving markets
• Less costs for emission control
• Less hazardous waste (less
costs)
• Savings (less expenditures for
chemicals)
• Less risk for liability claims
(costs) or high insurance costs
• Increased goodwill/reputation
www.kemi.se
Substitution when
authorising pesticides Part II
Functionality
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Crop-protection will always be needed.
Means of achieving protection of the crop
will vary.
Chemicals have to compete with technical
and biological measures some of which
may have advantages by being less
hazardous to health and to the
environment but also with other chemicals
that constitute less risk.
www.kemi.se
Substitution when
authorising pesticides
Functionality cont.
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In order to compete chemicals have to
improve their health and environmental
risk profile.
Usually it is the market that is the driving
force but for chemicals the appropriate
information is not available to the buyer of
the products and for pesticides the market
is also preserved by the existence of an
official approval system.
A solution is to also introduce substitution
at the level(s)where the knowledge of
possible health and environmental risks is
best.
www.kemi.se
Comparative Assessment:
HOW
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Compare products with the same
functionality e.g. products against
potato blight.
Compare
• Risk/hectare dose and frequency
• Benefits and possible differences in
functionality (e.g. mode of action
and therefore possibility of
resistance)
• Economic parameters
Make a risk-benefit analysis and
substitute if adequate
www.kemi.se
Requisite for a substitute
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Present significantly less risk to
health and the environment
Is sufficient efficacious on the
target organisms taking into
account the risk for development
of resistance
Are without significant economic
or practical disadvantages for the
user
www.kemi.se
At which level?
Knowledge
of local
Conditions
Knowledge
of health
/environmental risks
Harmonised
market/influence
on competition
Active
substance
Level
EU
decision
Poor
Very good
Fully harmonised
Market. No
distortion of
competition
Product
level
MS
decisions
Fair
Very good
Market not
harmonised some
distortion of
competition
Farmer
level
(product)
Good/
best
No influence
No tools
available
today to
communicate
risk
www.kemi.se
Hurdles when doing
Comparative Assessment
• In many cases it is impossible to
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judge if a product is worse from
a health and environmental
standpoint and then
substitution should not be
enforced.
This must be expressed clearly
but should not be a barrier for
using it when substitution
obviously is both possible and
beneficial.
www.kemi.se
Why use substitution for
authorized (safe!) products?
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Because when pesticides has highly
hazardous properties and exposure
can not be eliminated which is often
the case for health risk estimates and
always the case in environmental risk
estimates, there is considerable
residual concern.
Substitution should only be used for
substances which are still of concern
(e.g. in the orange zoon of the traffic
light symbol)
www.kemi.se
Establishing a risk-benefit
comparison of several
substances creates difficulties!
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Yes, if one substance is
hazardous to health and the
other to the environment then it is
not possible to use substitution.
No, it may also simplify things. In
many cases it is easier to
compare than to make an
absolute estimate of the risk. Due
to the same exposure scenario
simplification of the equation may
be done.
www.kemi.se
Temporary dip in number of
registered products
800
700
600
500
400
300
200
100
0
Approved pesticides
2001
1999
1997
1995
1993
1991
1989
1987
Withdrawn under the
year, all reasons
Year
www.kemi.se
Comparative assessment in the
decision-making process
Level of concern
Withdrawal due to
policy criteria
Withdrawal or
phasing out due to
risk assessment
Comparative risk and
benefit assessment at
product level
Aim
for
the
future
Simplified
procedures
www.kemi.se
Some practical examples
A group of chemically related
substances
Persistence
High
Low
Mobility
Low
High
9 Jan 2003
www.kemi.se
Some practical examples
A group of chemically related
substances
Persistence
High
Low
Mobility
Low
High
9 Jan 2003
www.kemi.se
Step by step approach in phase out
plans - the potatoes fungicide
example
The aim of the plan was to:
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Reduce the use of substance E
considerably
Promote development and use of less
risky alternatives
Main concerns:
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Adverse effects in long term studies
Repeated exposure for operators
Probable leakage of the a mobile
metabolite to groundwater
www.kemi.se
Step by step approach in
phase out plans
Restrictions:
• Only in potatoes and onions
• Only in mixed formulations
• Preharvest interval of 30 days
• Re-entry interval of three days
into the field
www.kemi.se
Sold quantities of potato
late blight products in Sweden
700
Active substance in tonnes
600
500
400
Alternative
300
200
100
0
1990
1991
1992
1993
1994
1995
1996
1997
www.kemi.se
1998
1999
2000
2001
In Conclusion
Practising substitution and
comparative assessment in
authorisation
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Is most effective at the level of approval of
products (knowledge best)
Shows that it is easier to rank and
compare than to quantify potential risks
Will act as a market force by promoting
development and use of less risky
pesticides
Is to minimize risks while keeping plant
protection performance at a high level
Will promote manufacturers that want to
market low risk products.
Has the potential to become a valuable
tool for risk reduction within most
countries.
www.kemi.se