Overview and Comparison of PBT and vPvB Criteria in EU and USA

Little Pro on 2017-05-25

PBT substances are substances that are Persistent, Bioaccumulative and Toxic (PBT). vPvB substances are substances that are very Persistent and very Bio-accumulative (vPvB). PBT substances and vPvB substances pose big threats to human health and the environment. When you register a chemical substance or identify its hazard, you often need to determine whether the substance belongs to a PBT substance or vPvB substance or not. In this article, we try to give you an overview and comparison of PBT and vPvB criteria in EU and USA. 

Comparison of PBT and vPvB Criteria

In EU, PBT and vPvB criteria are set out in REACH annex XIII. In the US, EPA describes PBT criteria in the PBT category for Premanufacture Notices in the Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances under TSCA and in the final rule for TRI reporting of PBT Chemicals . These criteria are used by the PBT Profiler to estimate PBT potential of chemicals.

The table below compares the PBT and vPvB criteria in EU and US. Substances are considered as PBT or vPvB substances when they fulfil the criteria for all three inherent properties P, B and T or both of the inherent properties vP and vB, respectively.

Item REACH Annex XIII EPA PBT Profiler *
  • Half-life in marine water > 60 days; or
  • Half-life in fresh or estuarine water is higher > 40 days;  or  
  • Half-life in marine sediment > 180 days;  or  
  • Half-life in fresh or estuarine water sediment > 120 days; or  
  • Half-life in soil is > 120 days.
  • Half-life in water, soil, and sediment>60 days; or
  • half-life in air> 2 days
  • Half-life in marine water, fresh or estuarine water is higher > 60 days;  or  
  • Half-life in marine, fresh or estuarine water sediment > 180 days; or  
  • Half-life in soil is > 180 days.
  • Half-life in water, soil, and sediment>180 days; 
  • BCF>=2000 
  • BCF>=1000
  • BCF>=5000 
  • BCF>=5000
  •  Long-term no-observed effect concentration (NOEC) or EC10 for marine or freshwater organisms <0.01 mg/L; or
  • The substance meets the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2); or
  • There is other evidence of chronic toxicity, as identified by the substance meeting the criteria for classification: specific target organ toxicity after repeated exposure (STOT RE category 1 or 2).
  • High concern: Fish chronic value ChV <0.1mg/L
  • Moderate concern: Fish chronic value ChV: 0.1mg/L-10mg/L

Note *:The criteria for T in PBT profiler does not consider health hazards. However, when EPA reviews a chemical for its PBT characteristics, they also consider potential human health effects due to environmental exposure in addition to aquatic toxicity. 

Information Useful for PBT and vPvB Assessment

Item Screening level High tier studies
  • Ready biodegradability
  • Inherent biodegradability
  • Abiotic degradation such as hydrolysis, photolysis, etc;
  • QSAR prediction
  • Simulation testing on degradation in surface water, soil or sediment; or
  • Field studies
  • Octanol-water partitioning coefficient logKow (i.e. If logKow<4.5, it is unlikely for a substance to reach a BCF value of 2000)
  • QSAR prediction
  • Bioaccumulation study in aquatic species (i.e. fish); or
  • Other information such a bioaccumulation study in terrestrial species or biomagnification info in the food chain.

Read more:

PBT, vPvB and POPs

Certain substances fulfilling the PBT/vPvB criteria may also be eligible to be included in the Stockholm Convention on Persistent Organic Pollutants (POPs). Even if the criteria for identifying POPs are not exactly the same as the PBT/vPvB criteria, they do partly overlap. The POPs criteria also include potential for long-range transport as an additional criterion compared to the PBT/vPvB criteria.


Having Questions?

We do not provide consultancy services. If you have questions or need any help, please contact our sponsor. You may also find an expert in CSP business directory below. If you are a consultant, you may get yourself listed in CSP business directory (free) or sponsor this page to leave your contact info on this page..

 Tags: Topics - CRAEnvironmental Risk Assessment