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MARINE RISK ASSESSMENT
b. the concern that remote areas of the oceans should remain untouched by hazardous
substances resulting from human activity, and that the intrinsic value of pristine
environments should be protected.
These concerns particularly occur with substances that can be shown both to persist for long
periods and bioaccumulate in biota, and can give rise to toxic effects after a greater time and at a
greater distance than chemicals without these properties. While this is also true for the
freshwater environment, the additional concern in the marine environment is that once the
chemical has entered the open seas, any cessation of emission will not necessarily result in a
reduction in chemical concentration and hence any effects become difficult to reverse. Equally,
because of the long-term exposures and long-life-cycle of many important marine species,
effects may be difficult to detect at an early stage.
For PBT substances a “safe” concentration in the environment cannot be established with sufficient
reliability. The PBT assessment is particularly developed to take into account the unacceptable high
uncertainty in predicting reliable exposure and/or effect concentrations hampering quantitative risk
assessment. The PBT assessment basically consists of two different steps:
• identification of PBT substances using specific criteria for the inherent properties; and
• an evaluation of the sources, major emissions and pathways to the marine environment to
sufficiently establish the most appropriate and effective measures to reduce the releases to
the marine environment.
The urgency and stringency of possible measures may, however, be dependent on the potential
of the substance to be transported to the open sea. This can be assessed qualitatively by
considering the use pattern, volumes and emissions or by using measured data. Open
applications and wide dispersive uses of the substance are regarded particularly relevant as well
as non-minimised direct discharges from production, formulation and industrial use.
4.4.2 PBT criteria
The criteria to be used to decide if a substance must be regarded as a PBT substance are
summarised in Table 30 below. The testing strategies to obtain the data that are necessary to
decide whether a substance fulfils these criteria are given in separate sections on persistence,
bioaccumulation and toxicity. The table contains two sets of criteria, one for PBT substances and
a second category for so-called very persistent and very bioaccumulating substances (vPvB).
This second category is developed under the recognition that for substances that are very
persistent and bioaccumulate significantly in the food chain, high but unpredictable levels may
be reached in wildlife or man over extended time periods. For such substances it is not necessary
to demonstrate toxicity in laboratory testing as long-term effects can be anticipated anyway.
For most substances the available data will not allow to come to a definitive answer to the
question if the substance must be considered under the PBT assessment. Hence screening data
that identify whether the substance has a potential to be a PBT have to be made use of. The
testing strategies in the following paragraphs should be followed and further information should
be asked for accordingly. In deciding which information is requested (on P, B or T) care must be
taken to avoid animal testing where possible. This implies that when for several properties
further information is needed the assessment should be focussed on clarifying the potential for
persistence first. When it is clear that the P criterion is fulfilled a stepwise approach should be
followed to elucidate the B criterion, eventually followed by toxicity testing to clarify the T
criterion.
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