PBT criteria

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PBT - criteria - a thougthstarter for the
Ad - hoc Meeting on the development of the
criteria for Persistent, Bioaccumulating and
Toxic Substances (PBT). by Toralf Kaland ECB,
12 December 00
ECBI/72/00 add 4
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The aim of the presentation 1. Give a
overview and outline some thoughtstarters on
the PBT- concept 2.
Identification of elements for further discussion
in relation to Directive
67/548/EEC.
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• PBT - introduction
• 1. Discussed or under discussion in several
  international bodies, and in
  different framework / context
• - OECD - UNECE LRTAP
• - US - EPA - UNEP POP
• - OSPAR - HELCOM
• 2. Examples of EU Legislations relevant to
  evaluation of PBT substances
• Directive 67/548/EEC (C L)
• Regulation 793/93/EEC and Directive 93/67/EEC
  (New and existing chemicals)
• Directive 98/8/EC (Biocides)
• Directive 91/414/EEC (Plant Protection Products)
• Water Framework Directive
• 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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PBT - introduction (cont.) 3. Common
fundamental basis / characteristic -
potential emission should be reduced for the
identified PBTs - development of testing
strategy and criteria
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The PBT-pyramide
I
Regulatory approache(s)
?
III
PBT - content
Implementation
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• I . Potential Regulatory approache(s)
• 1. Priority Setting / selection of
  hazardous substances
• example OSPAR - initial selection procedure of
  substances of possible concern
• POP - selection of POP-candidates
• 2. Risk Assessment / Risk Reduction Measure
• example EU - new and ex. chemicals / the
  Open Sea Scenario
• 3. Identification and selection of
  PBT-substances covered by
• Directive 67/548/EEC
• 4. Other approache(s) ........

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• II . PBT - content / definition
• 1. Criteria
• i). Hazard based criteria (C L)
• PBT
• PB(T)
• PB
• ii). Risk based criteria (POP, OSPAR, ex.
  chem, new chem, WFD, biocide.)
• PBT exp.
• PB(T) exp.
• PB exp.
• Exp. potential exposure

Stepwise procedure
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• II . PBT - content / definition (cont.)
• iii). Potential exposure
• load, emission (volume, use category, ....)
• occurance / monitoring
• POP the potential for long-range atmospheric
  transport
• - Vp lt 1000 Pa
• - T1/2 (atmospheric) gt 2 days
• - monitoring data showing that the
  substance is found in remote regions

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• II . PBT - content / definition (cont.)
• 2. Criteria and cut off values
• non - compartment specific
• - one set of criteria and corresponding cut off
  values
• compartment specific
• - several set of criteria and values
• - aquatic (marine, limnic)
• - terrestrial (in soil and above the ground)
• - sediment
• - groundwater
• - air

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• II . PBT - content / definition (cont.)
• 3. Substances which not fulfill the PBT-
  criteria / safety net
• metals
• endocrine substances
• other substances ?

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• II . PBT - content / definition (cont.)
• 4. Some key issue
• many different options
• test strategy available test protocols and
  information
• the criteria and cut-off values will normally
  depend on the pre - defined regulatory approach
  of the PBT concept

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• III . Implementation of the PBT - concept
• potential regulatory possibilities and benefits
  in the framework ?
• possible outcome and consequences ?
• roles and responsibilities (DG ENV, ECB, MS,
  IND) ?

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• Example
• OSPAR / DYNAMEC
• - initial selection
• - ranking
• - expert judgement and
• advises

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• Example OSPAR / DYNAMEC (cont.)
• Proposed cut-off values for the Selection
  Critera used in the Initial Selection Procedure
  
• Persistency (P) ...........................
  Half-life (T1/2 ) of 50 days and
• Liability to bioaccumulate (B) ....log Kowgt 4
  or BCF gt 500 and
• Toxicity (T) ....................................
  .. T aq acute L(E)C50 lt 1 mg/1, long term NOEC
  lt 0,1 mg/l
• or
• T mammalian CMR or chronic toxicity
• different types available information allowed
  to use is specified

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• Example UNEP POP
• Proposed cut-off values for the UNEP POP
  negotiation POP - candidates
• Persistency (P) ...........................
  Water half-life (T1/2 ) of 2, 6 months
• Sediment/soil half-life (T1/2 ) of 6
  months
• Liability to bioaccumulate (B) ....log Kowgt 4,
  5 or BCF gt 5000
• Toxicity (T) ....................................
  .. all substances provided with Risk Phrases
  suggesting evidence of harm to humans or the
  environment , and cancer Group 1, 2A, 2B (IARC).
• Additional values on half-life (atmosphere),
  Vp, occurance

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• Example EU new and existing chemicals / Open
  Sea Scenario
• Preliminary draft on proposed cut-off values for
  Open Sea Scenario. Selection for risk reduction
  measure.
• Persistency (P) ...........................
  Marine water half-life (T1/2 ) of 60 days
  
• Sediment half-life (T1/2 ) of 180
  days
• Liability to bioaccumulate (B) ....log Kowgt 4,
  5 or BCF gt 5000
• Toxicity (T) ................................. T
  aq acute L(E)C50 lt 1 mg/1, long term NOEC
  lt 0,1 mg/l
• or T mammalian CMR or
  chronic toxicity
• Emission/load ..............................
  text proposal under drafting
• different types available information allowed
  to use is proposed

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