6.4.1 In order to approve the application, the
Organization should determine that the Active Substances, Preparations
or Relevant Chemicals are not Persistent, Bioaccumulative and Toxic
(PBT). Preparations that exceed all these criteria (Persistence, Bioaccumulation
and Toxicity) in the table below are considered PBT.
Table 1 Criteria for
identification of PBT substances
|
Criterion
|
PBT criteria
|
| Persistence
|
Half-life:
> 60
days in marine water, or
> 40 days in freshwater*, or
> 180 days in marine sediment, or
>
120 days in freshwater sediment*
|
| Bioaccumulation
|
BCF > 2,000 or
LogPoctanol/water ≥3
|
| Toxicity
|
Chronic NOEC < 0.01 mg/l
|
| * For the purpose of marine environmental risk assessment
half-life data in freshwater and freshwater sediment can be overruled by
data obtained under marine conditions.
|
6.4.2 The Organization should determine the overall
acceptability of the risk the Preparation may pose in its use for
ballast water management. It should do so by comparing the information
provided and the undertaken assessment of PBT and the discharge with
scientific knowledge of the Active Substances, Preparations and Relevant
Chemicals concerned. The risk evaluation should qualitatively take
into account cumulative effects that may occur due to the nature of
shipping and port operations.
6.4.3 The risk evaluation should consider the
uncertainties involved in the application for approval, and as appropriate,
provide advice on how these uncertainties can be dealt with.
6.4.4 An Emission Scenario Document (ESD) should
be provided by the applicant as part of the Risk Assessment procedure
for ballast water management systems. The ESD should be based on the
worst-case discharge scenario and should be regarded as the first
stage of a stepped approach to the development of a full ESD, when
more data on potential discharges and technologies becomes available.