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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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Industrial chemicals

over 5 decades

By Finn Bro-Rasmussen, former president of EU/CSTE, Prof. emer., DTU Denmark


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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


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EINECS (1981) – a register of

100.106 EXISTING chemicals


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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


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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 on65%

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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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


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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)


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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?)


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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


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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


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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


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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


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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


5 key demands the copenhagen declaration 2000

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’


Basic political requirements cf council resolutions march june 2001

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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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!


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- 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)

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The background


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