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).
2 Currently there is no compelling physiological or empirical proof that marine organisms are more sensitive than freshwater organisms or vice versa. Should this however be demonstrated for the substance under consideration, this should be taken into account.
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 guidance3.
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
1 Such as relevant OECD guidelines or equivalent.