5.1 An assessment on the intrinsic properties of the Active Substance and/or preparation such as persistency, bioaccumulation and toxicity should be conducted¹. This evaluation should be performed for both the Active Substance or preparation and the effluent of ballast water treated with the Active Substance or preparation.

　

.1 Persistence tests:

 The persistence should preferably be assessed in simulation test systems that determine the half-life under relevant conditions. Biodegradation screening tests may be used to show that the substances are readily biodegradable. The determination of the half-life should include assessment of metabolites with Persistence, Bio accumulative and Toxic-characteristics.

　

.2 Bioaccumulation tests:

 The assessment of the (potential for) bioaccumulation should use measured bio-concentration factors in marine (or freshwater) organisms. Where these are not available BCF values may be estimated from the octanol/water partition coefficient (Kow) using QSAR models. Where use is made of existing bio-concentration data, reference should be made to the relevant records and procedures used.

　

.3 Toxicity tests:

 For persistent and bioaccumulative substances long-term exposure should be anticipated and expected to cover the whole life-time (or life span) of an organism and even multiple generations. Therefore chronic or long-term ecotoxicity data, ideally covering the reproductive stages should in principle be used for the assessment of the Toxicity criterion.

　

　

5.2.1 Toxicity testing is required for both the Active Substance or preparation and the Ballast Water effluent. For both a clear dose- effect relationship should be established through testing. This specific testing may be omitted if the necessary information on dose-effect relationships is available from other equivalent tests.

　

5.2.2 The toxicity of an Active Substance in ballast water must begin as highly toxic and gradually become nontoxic due to volatilization, reaction, or degradation. If it does not follow this degradation pattern, it will either be ineffective or too risky to discharge. Laboratory testing will be used to demonstrate this process and to verify that no other toxic compounds have formed which might persist. It has to be shown that there are no non-rapidly degradable active substances or metabolites of these in the discharge.

　

5.2.3 In order to test the toxicity for the Ballast Water Discharge, the first step is to determine a maximum active substance product concentration, which might be used. The next step is to add the product to seawater up to that concentration and hold under conditions that are as close as possible to actual use in a ballast tank. These storage conditions would include 10 in the dark. The surface area to volume ratio of the storage container should be as small as practical in order to resemble a ballast tank. The storage container should be made out of a substance to which active substances would not adsorb or react.

　

5.2.4 Toxicity testing simulating the ships' ballast water treatment, and the degradation of Active Substances within, must demonstrate a lack of aquatic toxicity of the effluent at Ballast Water discharge. The results of the proposed ballast water discharge toxicity testing must demonstrate environmental acceptability, e.g. defined through the NOEL (See Approval Criteria). The earliest sample to have no statistically significant toxicity relative to a control will be the indicator of the minimum time needed before discharge. This minimum time shall be reported in the proposal for approval.

　

5.2.5 The effluent toxicity tests must be conducted on samples drawn from the storage container [at 6, 12 and further every 24 hours] over a time period chosen so that the estimated time for the disappearance of toxicity is near the end of the period. A pretest may be needed to estimate the time for disappearance of toxicity. The pretest may also determine the most sensitive species so that only that species needs to be tested with all of the samples. Concentration series are unnecessary since a time series is the testing goal.

　

　

5.2.6 The testing schedule above involving samples drawn from the storage container may be modified as long as at least one of the samples is toxic and a subsequent sample is nontoxic. Caution in setting an alternative testing schedule should be exercised so that the minimum time needed before ballast water discharge is not underestimated and that harm to the marine environment is avoided.

　

5.2.7 The toxicity tests for Active Substances or preparations must be carried out in accordance with internationally recognized guidelines, preferably those of the OECD (1993)², ISO or other equivalent tests.

　

5.2.8 Tests should be conducted in accordance with the principles of good laboratory practice and be performed at laboratories that have GLP (Good Laboratory Practice) Certificates.

　

5.2.9 Laboratory testing should be conducted using filtered and sterilized salt water and fresh water sequentially. [One of these tests may be omitted subject to confirmation of equivalent safety and reactivity.]

　

5.2.10 For the toxicity testing, the evaluation of preparations or Active Substances [or toxic components of the Active Substances] should include a 96-hour acute toxicity test with fish, a 48-hour acute toxicity test with a crustacean, and an appropriate test with microalgae (or similar organism). One test on chronic aquatic toxicity of persistent metabolites must be conducted (including any byproducts, side products and end products). [The results from the most sensitive test will be used in ranking according to the GESAMP Hazard Evaluation Procedure published by the Organization]. The following three species should be used: fish (LC50), crustacea (EC50) and micro-algae (IC50).

　

5.2.11 The ballast water discharge testing should include evaluation of Bioaccumulation, Persistence and Toxicity as required in paragraph 5.1. To this end, for example the EU Technical Guidance Documents (TGD's) can be used or the Whole Effluent Assessment (WEA) under the OSPAR Hazardous Substances Strategy. Both the WEA and the EU TGD's consists of a variety of (biological) tests to the determine persistence, bioaccumulation and toxicity (PBT-criteria). The WEA can specifically be applied to the entire effluent sample. These procedures, or an equivalent combination of US EPA protocols or other procedures, can be used to assess PBT.

　

　

6.1 Ballast Water Management Systems containing Active Substances or preparations containing one or more Active Substances are to be evaluated and approved by the Organization in order to protect the ship, the crew and the marine environment from adverse effects related to their use.

　

　

6.2.1 In order to protect the ship's safety the technical group should evaluate the physical and chemical hazards (see paragraph [...]) and to ensure that potential hazardous properties of the Active Substances or the reaction products formed in the treated ballast water will not create any unreasonable risk to the ship. Proposed procedures for the use and technical equipment introduced have to be taken into account.

　

[6.2.2 In order to protect the ship's safety the proposal shall include a (Material) Safety Data Sheet ((M)SDS). The Organization should evaluate the (M)SDS to determine the physical and chemical hazards (see paragraph ...) and to ensure that potential hazardous properties of the Active Substances or the reaction products formed in the treated ballast water will not create any unreasonable risk to the ship. This evaluation should take into account the different circumstances that a ship may face in its trade (e.g. ice, tropical humidity etc.). Proposed procedures for the use of the Active Substance or preparation and the technical equipment to be installed for it have to be taken into account.]

　

　

6.3.1 Moderate toxicity at the time of ballast water discharge may be necessary for some Active Substances to accomplish the intended purpose of preventing the introduction of potential disease organisms. Under some circumstances, ballast water toxicity might need to persist until discharge in order to meet discharge standards for harmful organisms.

　

　

6.3.2 In order to approve the application, the Organization shall determine that:

　

6.3.3 The information for the substance has been provided is complete, of sufficient quality and in accordance with these guidelines;

　

6.3.4 That this information does not indicate possible unacceptable adverse effects to safety, human health or the environment;

　

6.3.5 The Active Substance or preparation, their intermediate products, side products and end products are not Persistent, Bioaccumulative and Toxic (PBT). This shall be determined according to the following cut-off values.

　

6.3.6 A discharge standard has been set which ensures that discharges remain under the toxicity limits of the Active Substance or preparation and associated intermediates, side products and end products and that in any case that these substances combined have a toxicity value higher than [NOEC 10 mg/l][for acute toxicity LC/EC/IC50 100 mg/l and for chronic toxicity NOEC [10][0.1] mg/l].⁴ [According to revised GESAMP Hazard Profile rating scheme, both ratings apply [1] for B1 acute aquatic toxicity and B2 chronic aquatic toxicity];

　

6.3.7 The proposed manner of application and the instructions for use of the Active Substance or preparation are sufficient to guarantee that the discharge standard mentioned in paragraph 6.3.5 is met at all times and that no adverse effects occur to human health, the safety of the ship and crew and the marine environment;

　

6.4.1 Sustainable ballast water treatment systems utilizing Active Substances should get to the point where residual toxicity in the ballast water discharge is no longer necessary. Not only will this mean that the environmental risk will be low, but there will be simply a need to note the time elapsed from treatment to discharge.

　

6.4.2 Toxicity testing simulating the ship's ballast water treatment and degradation of Active Substances within must demonstrate a lack of aquatic toxicity of effluent at Ballast Water Discharge. The results of the proposed ballast water discharge toxicity testing must demonstrate environmental acceptability, e.g. defined through the NOAEL. The earliest sample to have no statistically significant toxicity relative to a control will be the indicator of the minimum time needed before discharge. The aquatic toxicity of Active Substances Products or the Active Substances at discharged ballast water should be limited to LC/EC/IC50 >[ 100] mg/l and a NOEC >[0.1] mg/l. According to revised GESAMP Hazard Profile rating scheme, both ratings apply [1] for Bi acute aquatic toxicity and B2 chronic aquatic toxicity.

　

6.4.3 The toxicity of an Active Substance in ballast water must begin as highly toxic and gradually become nontoxic due to volatilization, reaction, or degradation or it will either be ineffective or too risky to discharge. Laboratory testing will be used to demonstrate this process and to verify that no other toxic compounds have formed which might persist. It has to be shown that there are no non-rapid degradable active substances or metabolites of these in the discharge.]

　

　

　

　

7.1.1 The proposal for approval of an Active Substance or preparation shall include information on its intended use and application. The design of the ballast water management system and its operation must follow the instructions provided by the manufacturer. The quantity of Active Substances to be added to the ballast water and the maximum allowable concentration of the active substances herein must be described in the instruction. The system should ensure that the maximum dosage and maximum allowable discharge concentration are not exceeded at any time.

　

7.1.2 The quantities used and the achieved concentration of the Active Substances in the ballast water must be recorded in the Ballast Water Record Book as specified in Regulation B-3 of the Convention.

　

7.1.3 The Proposal shall include a (Material) Safety Data Sheet ((M)SDS). The (M)SDS should describe appropriate storage and handling, which should be implemented on board. Harmful chemicals may be generated during storage of an Active Substances Product on board by degradation or chemical reactivity.

　

　

7.2.1 Classification of hazards should conform to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and the relevant IMO regulations (e.g. the IMDG Code) and guidelines (e.g. the GESAMP Hazard Evaluation Procedure). Where these regimes are not applicable, relevant national or regional regimes should be followed.

　

　

7.3.1 Detailed procedures and information for safe application of Active Substances Products on board must be supplied and must comply with the approval conditions such as maximum allowable concentration and maximum discharge concentration, if any.

　

7.3.2 Procedures for safe application of Active Substances Product on board must be [described in the Ballast Water Management Plan] in accordance with Regulation B-1 of the Convention and relevant guidelines.

　

　

[7.4.1 Active substances that will not degrade until discharge

　

7.4.1.1 On board installations must be used to monitor and record (discharge volume, location, etc.) the discharge and approved to assure the approved discharge conditions.

　

7.4.2 Active substances that will degrade until discharge]

　

7.4.2.1 Ballast water, to which an Active Substance has been added, must not be discharged for a specific period of time as defined by approval. On board installations may be used to monitor the discharge and to assure that the discharge is safe.