Dias nummer 1

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Industrial chemicals over 5 decades
By Finn Bro-Rasmussen, former president of
EU/CSTE, Prof. emer., DTU Denmark

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Chemical risks illustrated - over 3 decades
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EINECS (1981) a register of 100.106 EXISTING
chemicals
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The EU chemical universe

• 100.000 EXISTING CHEMICALS
• 2.700 gt 1000 tons / yr (HPVC)
• 10.000 gt 10 tons / yr
• 30-40.000 gt 1 tons / yr

5
The empty data bases
50-150 EU priority chemicals Adequate tox.
Data - inadequate exposure data
Good data on 14 Incomplete data on 65 No data
on 21
For further 10-20.000 chemicals
Scattered/single tox.-data may be available
For all other chemicals NONE
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Principles of EU chemicals regulation
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The rationale of toxicological protection levels
100 50 0
Safety requirements
Adverse effects (diff. species - various effects)
Precaution required
Exposure conc. (mg/kg)
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Quality standards limit values - exemplified
Adverse effects
?
(PBDE?)
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Hazard - risk assessment
Risk-ratio
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Chemicals assessment
Identifying uncertainties
Risk-ratio
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The prevalent underclassification

• 19-20 of HPV chemicals are classified,
• - only 3-4 of all LPV MPV chemicals ?
• 15 of ca. 1000 EU hazardous chemicals
• are underclassified if related to data from
• RTECS database (cf. Swedish report, 2003)
• QSAR-evaluations suggest 44 of 42.000
• EINECS chemcials are classifiable
• (cf. Danish EPA-report, 2002)

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Group/category evaluations suggested
EXAMPLES
APPLICATIONS
Alkylated phenols Oil / lubricants, additives
Benzimidazoles Herbicides
Brominated flame-retardants Plast, textiles, electronics
Cadmium salts Electronics, plast, batteries
Chlorinated pesticides other POP chemicals In agri- horticulture. Indust. consumer prod.
Linear Alkylsulfonates (LAS) Wash clean products
Phthalates PVC-plast, paints, cosmetics
Siloxanes, cyclic Industrial oils, cosmetics personal care products
Triazine herbicides Herbicides
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QSAR ( Quantative Structure Activity
Relationship)

• QSAR models applied on 47.000 EINECS
• substances have indicated that
• Acute toxicity
• Skin sensitization
• Mutagenicity
• Cancerogenicity
• Ecotoxicity

• 20.624 or 44
• are found positive
• i.e.
• to be classified

) cf. Danish EPA Report on QSAR to OECD, 2003
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Industrial chemicals over two decades
Nordic countries EU 1981 EINECS
register Nordic productregisters 1995 Expert
report to Danish Parliament on
non-assessed chemicals 1996 The Esbjerg
declaration generation target 1997 Swedish
Chemical Strategy 1998 Danish List of unwanted
chemicals 2000 Swedish Chemical Strategy 2000
Copenhagen declaration 5 demands 2001
EU - White paper Council resolution 2002
EU - Technical consultations 2003
REACH
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5 key demands(The Copenhagen declaration 2000)
1 THE RIGHT TO KNOW 2 All marketed chemicals to
be tested and evaluated - PRECAUTIONARY PRINCIPLE
3 Phasing out of all persistant and
bioaccumulating substances- BANNING OF THE
POPs 4 Hazardous chemicals to be substituted
for less hazardous SUBSTITUTION
REQUIREMENT 5 All emissions of hazardous
chemicals to be stopped by 2020 GENERATION
TARGET
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Basic political requirementscf. Council
resolutions, March/June 2001

• Precautionary and substitution principles
• All chemicals (no data- no marketing)
• Registration and testing of chemical
• substances required
• Safety evaluations based on risk assess-
• ment not by volume
• Responsibility for data and risk assessment
• on producers, importers and downstream
• users

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REACH proposal A way forward!
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The background