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Industrial chemicalsover 5 decadesBy 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 of100.106 EXISTING chemicals
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The EU chemical universe
100.000 EXISTING CHEMICALS : 2.700 > 1000 tons / yr (HPVC)10.000 > 10 tons / yr 30-40.000 > 1 tons / yr
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For all other chemicals NONEThe empty data bases For further 10-20.000 chemicals: Scattered/single tox.-data may be available 50-150 EU priority chemicals Adequate tox. Data - inadequate exposure dataGood data on 14%Incomplete data on65%No data on 21%
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Principles of EU chemicalsregulation
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The rationale of toxicological protection levelsAdverse effects(diff. species- various effects)100%
50%
0%Exposure conc. (mg/kg)Precaution requiredSafety requirements
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Quality standards & limit values- exemplifiedAdverse effects?(PBDE?)
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Hazard - risk assessment
Risk-ratio
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Chemicals assessment
Risk-ratioIdentifying uncertainties
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The prevalent underclassification19-20% 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 suggestedEXAMPLESAPPLICATIONS
Alkylated phenolsOil / lubricants, additivesBenzimidazolesHerbicidesBrominated flame-retardantsPlast, textiles, electronicsCadmium saltsElectronics, plast, batteriesChlorinated pesticides & other POP chemicals In agri- & horticulture. Indust. & consumer prod.Linear Alkylsulfonates (LAS)Wash & clean productsPhthalatesPVC-plast, paints, cosmeticsSiloxanes, cyclicIndustrial oils, cosmetics & personal care productsTriazine herbicidesHerbicides
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QSAR models applied on 47.000 EINECSsubstances have indicated that:
Acute toxicitySkin sensitizationMutagenicityCancerogenicity Ecotoxicity
20.624 or 44 %
are found positive i.e.to be classified
QSAR (= Quantative Structure Activity Relationship)*) cf. Danish EPA: Report on QSAR to OECD, 2003
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Industrial chemicals over two decades Nordic countries EU1981 EINECS register & Nordic productregisters1995 Expert report to Danish Parliament on non-assessed chemicals 1996 The Esbjerg declaration generation target1997 Swedish Chemical Strategy1998 Danish List of unwanted chemicals2000 Swedish Chemical Strategy2000 Copenhagen declaration 5 demands2001 EU - White paper & Council resolution2002 EU - Technical consultations2003 REACH
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5 key demands(The Copenhagen declaration 2000)1THE RIGHT TO KNOW
2All marketed chemicals to be tested and evaluated -PRECAUTIONARY PRINCIPLE
3Phasing out of all persistant and bioaccumulating substances- BANNING OF THE POPs
4Hazardous chemicals to be substituted for less hazardous SUBSTITUTION REQUIREMENT
5All 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 principlesAll chemicals (no data- no marketing)Registration and testing of chemical substances requiredSafety evaluations based on risk assess- ment not by volumeResponsibility 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
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