5.3.1 For the Basic Approval process, fate and
effect testing should be performed in the laboratory with Active Substances
and Preparations. This section lists information that could be useful
for a preliminary risk characterization.
5.3.2 Both the Active Substance or Preparation
as well as the treated ballast water discharge should be subject to
toxicity testing in order to protect the receiving environment from
toxic effects due to discharges.
5.3.3 The reaction with organic matter of Active
Substances and Preparations that produce free radicals, should be
addressed qualitatively so as to identify products of concern to the
environment.
5.3.4 The rate and route of abiotic and biotic
degradation of the Active Substances and Preparations under aerobic
and anaerobic conditions should be assessed, resulting in the identification
of relevant metabolites in the relevant media (ballast water, marine
and fresh waters).
5.3.5 The rate of abiotic and biotic degradation
of the Active Substances and Preparations under aerobic and anaerobic
conditions should be assessed, resulting in the characterization of
the persistence of the Active Substances, Preparations and Relevant
Chemicals in terms of degradation rates under specified conditions
(e.g., pH, redox, temperature).
5.3.6 The partition coefficients (solids-water
partition coefficient (Kd) and/or organic carbon normalized distribution
coefficient (Koc)) of the Active Substances, Preparations and Relevant
Chemicals should be determined.
5.3.7 For Active Substances and Preparations,
the potential for bioaccumulation should be assessed in marine or
freshwater organisms (fish or bivalves) if the logarithm octanol/water
partition coefficient (logPow) is >3.
5.3.8 Based on the information on fate and behaviour
of Active Substances and Preparations, the discharge concentrations
at selected time intervals should be predicted.
5.3.9 The effect assessment of the Active Substances,
Preparations and Relevant Chemicals is initially based on a dataset
of acute and/or chronic ecotoxicity data for aquatic organisms, being
primary producers (algae or sea grasses), consumers (crustaceans),
predators (fish), and should include secondary poisoning to mammalian
and avian top-predators, as well as data for sediment species.
5.3.10 An assessment of secondary poisoning is
redundant if the substance of concern demonstrates a lack of bioaccumulation
potential (e.g., BCF <500 L/kg wet weight for the whole organism
at 6% fat).
5.3.11 An assessment of sediment species is redundant
if the potential of the substance of concern to partition into the
sediment is low (e.g., Koc <500 L/kg).
5.3.12 The effect assessment of the Active Substances,
Preparations and Relevant Chemicals should include a screening on
carcinogenic, mutagenic and endocrine disruptive properties. If the
screening results give rise to concerns, this should give rise to
a further effect assessment.
5.3.13 The effect assessment of the Active Substances,
Preparations and Relevant Chemicals, taking the indicated information
into account, should be based on internationally recognized guidancefootnote.
5.3.14 The results of the effect assessment are
compared to the results of the discharge toxicity testing. Any unpredicted
results (e.g., lack of toxicity or unexpected toxicity in the discharge
assessment) should give rise to a further elaboration on the effect
assessment.
5.3.15 An analytical method suitable for monitoring
Active Substances and Preparations in ballast water discharges should
be available.