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400 300 200 100 0

400 300 200 100 0. Industrial chemicals over 5 decades. By Finn Bro-Rasmussen, former president of EU/CSTE, Prof. emer., DTU Denmark. Brominated flame retardants in human breast milk. Increase. PCB in Swedish osprey.

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400 300 200 100 0

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  1. 400 300 200 100 0 Industrial chemicals over 5 decades By Finn Bro-Rasmussen, former president of EU/CSTE, Prof. emer., DTU Denmark

  2. Brominated flame retardants in human breast milk Increase PCB in Swedish osprey 1970 1975 1980 1985 1990 1995 2000 Reduction 1970 1975 1980 1985 1990 1995 2000 Chemical risks illustrated - over 3 decades

  3. EINECS (1981) – a register of 100.106 EXISTING chemicals

  4. 3-5 % of all chemicals 19-20% of HPV chemicals are CLASSIFIED as hazardous • ca. 2.700 NEW CHEMICALS - from 1981-1999 Minimum data set required > 10 kg/year ~ 40% of these are CLASSIFIED as hazardous 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

  5. ca. 2.800 HPVC chemicals: Human toxicity data exists for ……… 20 - 90% Ecotoxicity data exists for ……………… 5 - 55% QSAR data available for …………………… 15 - 50% 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

  6. Positive lists Negative lists + ca. 2.500 NEWchemicals (base set test) 3.000 regulated by classification & labelling (dir. 67/548+amendm.) 4-5.000 regulated by classification & labelling (dir. 67/548+amendm.) Highly regulated as food additives, pesticides etc. (< 2000) ~ 95% are neither tested nor evaluated Principles of EU chemicals regulation

  7. man animal Risk- zone Grey Zone Pre- caution zone ADI/TDI UF=10x10 MF=? The rationale of toxicological protection levels 100% 50% 0% Safety requirements Adverse effects (diff. species - various effects) Precaution required Exposure conc. (mg/kg)

  8. animal man Grey zone Pre- caution Zone Risk- zone Examples: From list of hazardous chemicals Examples: Pesticides in drinking water (WHO) ‘Modifying’ factor for infants Examples: Carcinogens Pesticides in drinking water (EU) < 100 priority chemicals risk evaluated Quality standards & limit values - exemplified Adverse effects ? (PBDE?)

  9. Data-set Data-set HAZARD (EFFECT) EXPOSURE Emission Toxicity Distribution Extrapolation Predicted exposure Zero-effect No-effect (PNEC) ________________ No-exposure (PEC) Hazard - risk assessment Risk-ratio

  10. LACK OF DATA Data-set Data-set HAZARD (EFFECT) EXPOSURE ! Variability ! Emission Toxicity ? Uncertainty ? ?? Extrapolation ?? Distribution Extrapolation ??? Accept level ??? Predicted exposure Zero-effect No-effect (PNEC) Lack of knowledge Prediction  Real life ________________ No-exposure (PEC) ? Negligible risk  No risk ? Chemicals assessment Identifying uncertainties Risk-ratio

  11. 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)

  12. Group/category evaluations suggested EXAMPLES APPLICATIONS

  13. 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 QSAR(= Quantative Structure Activity Relationship) *) cf. Danish EPA: Report on QSAR to OECD, 2003

  14. 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

  15. 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’

  16. 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

  17. Registration 30.000 > 1t/y Evaluation 5.000 > 100t/y AUTHORISATION Stepwise tested according to tonnage 10 t/y → 100 t/y → 1000 t/y CMR-POPs-PBT (vPvB?, EDC?) QSAR in vitro Self-classification/risk assessment Risk reduction or phase out  base-set  Level 1-2 REACH proposal: A way forward!

  18. - and the urge ” … Given our understanding of the way chemicals interact with the en-vironment, we are running a gigantic experiment with humans and all other things living.” Sir Tom Blundell, chairman UK Royal Commission (June 2003) 400 300 200 100 0 The background

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