3.1 Active Substances and Preparations may be added to the ballast water or be generated on board ships by technology within the Ballast Water Management system using an Active Substance to comply with the Convention.

　

3.2 Active Substances and Preparations accomplish their intended purpose through action on Harmful Aquatic Organisms and Pathogens in ships' ballast water and sediments. However, if the ballast water is still toxic at the time of discharge into the environment, the organisms in the receiving water may suffer unacceptable harm. Both the Active Substance or Preparation as well as the Ballast Water Discharge should be subjected to toxicity testing in order to protect the receiving environment or human health from toxic effects due to the discharges. Toxicity testing is needed to determine if an Active Substance or Preparation can be used and under which conditions the potential of harming the receiving environment or human health is acceptably low.

　

3.3 Ballast Water Management systems that make use of Active Substances and Preparations must be safe in terms of the ship, its equipment and the personnel to comply with the Convention.

　

3.4 The approval of Active Substances and Preparations using viruses or fungi for use in Ballast Water Management Systems is not addressed in this procedure. The approval of such substances for Ballast Water Management should require an additional consideration by the Organization in compliance with regulation D-3 of the Convention if the use of such substances is proposed.

　

　

　

4.1.1 The proposal for approval of an Active Substance or a Preparation should include a chemical identification and description of the chemical components even if generated onboard. A chemical identification should be provided for any Relevant Chemicals.

　

　

4.2.1 A proposal for approval should include information on the properties or actions of the Preparation including any of its components as follows:

　

4.2.2 A proposal for approval should include the above data set either for the Preparation or for each component separately, and a list of the name and relative quantities (in volumetric percentages) of the components should be also attached. As described in Section 8.1, all proprietary data should be treated as confidential.

　

4.2.3 The tests for Active Substances and Preparations should be carried out in accordance with internationally recognized guidelines¹.

　

4.2.4 The testing process should contain a rigorous quality control/quality assurance programme consisting of:

　

　

　

　

4.2.5 Dossiers already used for registration of chemicals can be submitted by the applicant to satisfy the required data needed for the evaluation of Active Substances and Preparations according to this procedure.

　

4.2.6 The proposal should describe the manner of application of the Preparation for Ballast Water Management, including required dosage and retention time.

　

4.2.7 A proposal for approval should include (Material) Safety Data Sheets ((M)SDS).

　

　

4.3.1 A proposal for approval should include an assessment report. The assessment report should address the quality of the test reports, the risk characterization and a consideration of the uncertainty associated with the assessment.

　

　

　

5.1.1 An assessment on the intrinsic properties of the Active Substance and/or Preparation such as persistency, bioaccumulation and toxicity should be conducted (see Table 1 in Section 6).

　

　

　

　

　

5.2.1 Toxicity testing is necessary for the Active Substance, or Preparations (see section 4.2.1 and 5.3) and the treated Ballast Water Discharge as covered in this section. The advantage of conducting toxicity testing on the Ballast Water Discharge is that it integrates and addresses the potential for interactions of the Active Substances and Preparations with the possible by-products.

　

　

　

5.2.2 The applicant should provide both acute and chronic toxicity test data using standardized test procedures to determine the toxicity of the Preparation and Relevant Chemicals as used in conjunction with the Ballast Water Management system. This testing approach should be performed on the treated Ballast Water Discharge, as the Ballast Water Management system could either mitigate or enhance the adverse effects of the Preparation or Relevant Chemicals.

　

5.2.3 The discharge toxicity tests should be conducted on samples drawn from the land-based test set-up, which would be representative of the discharge from the Ballast Water Management system.

　

5.2.4 These toxicity tests should include chronic test methods with multiple test species (a fish, an invertebrate and a plant) that address the sensitive life-stage. The preference is to include both a sub-lethal endpoint (growth) and a survival endpoint. Either freshwater or marine test methods should be tested²

　

5.2.5 The test results to be provided include: acute 24-hour, 48-hour, 72-hour, and 96-hour Lethal Concentration at which x % of the test organisms die (LCx), No Observed Adverse Effect Concentrations (NOAECs), chronic No Observed Effect Concentration (NOEC) and/or Effect Concentration at which x % of test organisms show effect (ECx), as appropriate based on the experimental design.

　

5.2.6 A dilution series including a 100% ballast water discharge would be tested to determine the no adverse effect level using the statistical endpoints (NOEC or ECx). An initial analysis could use a conservative approach where the dilution capacity would not be taken into consideration (no modelling or plumes analysis would be used). The rationale for taking a conservative approach is that there could be multiple discharges into one location (even though this is not necessarily the case).

　

5.2.7 The acute and chronic toxicity test data in conjunction with the information in Section 4.2.1 should be used to determine the holding time necessary to achieve the no adverse effect concentration upon discharge. Knowing the half-life (days), decay rate, dosage rate, volume of system and toxicity tests with time series, then a computational model can be used to determine the amount of time needed to hold the treated ballast water before discharge.

　

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 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 behavior 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.