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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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400

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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

1970 1975 1980 1985 1990 1995 2000

Reduction

1970 1975 1980 1985 1990 1995 2000

Chemical risks illustrated

- over 3 decades


EINECS (1981) – a register of

100.106 EXISTING chemicals


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


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


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


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)


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?)


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


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


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)


Group/category evaluations

suggested

EXAMPLES

APPLICATIONS


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


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


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!


- 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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