Potential use of biomonitoring for REACH Christiane Heiß Heiß
European Chemical Agency in Helsinki
Potential use of biomonitoring for REACH
German Federal Environment Agency in Dessau Christiane Heiß Heiß
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Overview
I. Main principles of REACH II. Exposure assessment III.Substances of very high concern IV.Conclusions
Potential use of biomonitoring for REACH
Christiane Heiß Heiß
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No data no problem ?
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90% of existing chemicals without data on risks Established and highly complex use patterns increasing public costs
•
160
Toxic ignorance causes safe uses and safe products required by 2020
=> EC/1907/2006 “REACH”
150 Index (1995=100)
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140 130 120 110 100 90 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 Production volume of toxic industrial chemicals Total volume of chemicals produced GDP CMR - chemicals
Source: REACH - BASELINE – Study, Prodcom, EUROSTAT 2007
Potential use of biomonitoring for REACH
Christiane Heiß Heiß
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REACH – aims and principles of governance
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Björn Hansen: „a very clear and strict framework for industry decisions. And if industry decided according to that framework, there would be hardly ever need to be an intervention from outside”.
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Registration => no data no market Evaluation => authorities focus their work on uncontrollable risks and substances of very high concern (SVHC)
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Authorisation => Incentives for substitution and lower-risk use of Chemicals
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Use of market mechanism for regulatory aims Capacity building for comprehensive risk competence
Potential use of biomonitoring for REACH
Christiane Heiß Heiß
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New balance of shared responsibility
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Governance by information requirements („no data no market“)
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Risk assessment for all stages of life cycle Obligation for industry to guarantee safe processing and safe products within value chains
• • • •
Obligatory communication and cooperation Only 5% of substances are evaluated by authorities Targeted regulation for substances of very high concern (SVHC) Obligatory precaution through authorisation of SVHCs
Potential use of biomonitoring for REACH
Christiane Heiß Heiß
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Improved risk information with REACH
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Output I: hazardous substance inventory Classification and Labelling – All CMR-substances with harmonized information for authorities and downstream users
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Output II: recommendations on suitable use conditions for all professional uses (Safety Data Sheet)
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Output III: options for risk information bottom up and top down
Potential use of biomonitoring for REACH
Christiane Heiß Heiß
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Information flow
ECHA
Art. 33 SVHC substances in articles > 0.1 %
Art. 123
Art. 119 Electronic public access: P/C data, DNEL, PNEC, Analytical Methods
Communication on risks of substances Art. 124 & 127 Monitoring
Annex I Identify SVHC via other evidence
Local authorities & public
Potential use of biomonitoring for REACH
Christiane Heiß Heiß
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II. Exposure pathways Emission to air
Sewage sludge waste water treatment
Treatment of processing water
soil
Solid waste
raw material Products
Exposure Assessment: workers
100 90
Basis for Exposure [%]
80 70 60 50 40 30 20 10
Source: REACH - BASELINE – Study, Prodcom, EUROSTAT 2007
0
Potential use of biomonitoring for REACH
LPV RAR
MPV Review
HPV
SVHC
Modelling
Default
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Conclusions I
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exposure information are mostly model-based and submitted by industry => quality control
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Thresholds for all dangerous substances and impact areas enable risk assessment of measured data
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Extensive self responsibility of industry calls for an immission/ impact based monitoring system
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Need for indicators containing both, humans and environment Human biomonitoring data are helpful for success control
Potential use of biomonitoring for REACH
Christiane Heiß Heiß
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Substances of very high concern (SVHC)
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„To ensure a sufficiently high level of protection for human health, including (…) certain vulnerable sub-populations, and the environment, substances of very high concern should, in accordance with the precautionary principle, be subject to careful attention.“
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Identification based on certain substance properties (Art. 57, Annex XIII)
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Priorisation due to wide dispersive use & large production volumes (Art. 58)
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Obligatory Minimisation of emissions by industry ( Art. 60, 10)
Potential use of biomonitoring for REACH
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Substances of very high concern Persistence & remobilisation Increasing burdens in remote areas Bioaccumulation along foodwebs Cancerogenic/ Mutagenic/ Reprotoxic Flood August 2002
Endocrine effects ng/g fresh weight
• • • • •
Source: ESB, 2008 Potential use of biomonitoring for REACH
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Substances of very high concern
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Persistence & remobilisation Increasing burdens in remote areas POPs, DecaBDE, PFT
Potential use of biomonitoring for REACH
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Christiane Heiß Heiß
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Substances of very high concern
• • •
Persistence & remobilisation Increasing burdens in remote areas Bioaccumulation along foodwebs
Potential use of biomonitoring for REACH
Substances of very high concern
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Persistence & remobilisation Increasing burdens in remote areas Bioaccumulation along foodwebs 0,5
long term Toxicity
PCB in human blood [µg/L]
0,4
n =1060
0,3
Breast-fed
0,2
Not Breast-fed
0,1 0,0
7-8 J.
9-10 J.
11-12 J.
13-14 J.
Source: Kinder-Umwelt-Survey, Becker, K. et.al: WaBoLu Heft 01/07 Potential use of biomonitoring for REACH
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Substances of very high concern
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Persistence & remobilisation Increasing burdens in remote areas Bioaccumulation along foodwebs Toxic Cancerogenic/Mutagenic/ Reprotoxic Endocrine effects
source: Reiersen AMAP, 2008 Potential use of biomonitoring for REACH
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REACH and Monitoring: Conclusion II
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Request for human and biomonitoring data to identify SVHC and review the Annex XIII criteria
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Request for human and biomonitoring data to support decision making about need for action
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Request for long-term monitoring data to control success of precautionary measures
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Success of REACH depends on the willingness and ability of authorities to cooperate and exchange information
Potential use of biomonitoring for REACH
Christiane Heiß Heiß
Contact:
Useful links:
[email protected]
http://echa.europa.eu/
Federal Environment Agency (UBA) Division IV Chemical and Biological Safety Section IV 2.3 Chemicals W örlitzer Platz 1 06844 Dessau Fon: Fon: +49+49-340340-21032103-3159 Fax: +49+49-340340-21042104-3015
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http://ecb.jrc.ec.europa.eu/ http://www.norman-network.net/index_php.php http://www.amap.no/
Thanks to: Christa Schröter-Kermani, Kerstin Becker, Michael Neumann
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