endocrine disruptors: the eu regulatory...
TRANSCRIPT
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ENDOCRINE DISRUPTORS:
THE EU REGULATORY FRAMEWORK
Ladislav Miko, SANTE
Brussels, 1st June 2015
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Outline
EU legislation on endocrine disruptors (EDs)
Regulation on Plant Protection Products and Biocidal products + criteria to identify EDs
The Impact Assessment
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Specific provisions on EDs
Water Framework Directive (2000)
REACH Regulation (2006)
Regulation on Plant Protection Products (2009)
Regulation on Cosmetics (2009)
Regulation on Biocidal Products (2012)
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Adverse effects caused by EDs already covered by "standard" risk
assessments
Chemicals (REACH) Plant protection products Biocidal products Cosmetics Workers legislation Food Contact Materials Toys Medical Devices ....
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Outside EU: no criteria to identify EDs for regulatory purposes
EU legislation: already high protection from EDs to human health & environment
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Regulations on Plant Protection Products
& on Biocidal Products
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Regulatory consequences for EDs already defined
Interim criteria to identify EDs set
New criteria required by end 2013
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Regulatory consequences for EDs
PPP ED is "approval criterion" (strong hazard component)
Art. 4.7 derogation in case of serious danger to plant health
BP Professional use: (strong risk component + Art 5.2
derogation for disproportionate negative impact on society)
Consumer use: hazard-based non-approval
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High political attention on criteria to identify EDs
Council Conclusions (2012)
European Parliament Resolution (2013)
7th EAP (2013)
• Horizontal criteria
• Impact assessment
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Studies/Opinions requested
• Kortenkamp Report (2011)
• EFSA Opinion (2013)
• JRC Expert Advisory Group Report (2013)
2009-2013: COM work for developing criteria
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Activities • Ad-hoc WG (lead by DG ENV)
• ED Expert Advisory Group (lead by JRC)
• COM Conference 2012
• 1st draft for criteria:
o discussed in the Ad-hoc WG
o consensus not reached
o formal COM Inter-Service Consultation did not start
2009-2013: COM work for developing criteria
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Science divergences
Criteria to identify EDs likely to impact other sectors
Regulatory consequences vary across sectors (decision making based on hazard/risk/risk-benefit)
Significant impacts expected depending on criteria and sectors
Different legal procedures to implement criteria
Complexity
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2013 start of an Impact Assessment
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Impact Assessment well on track
..more details in next presentations
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