MEPC 57/21 

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ANNEX 1 

RESOLUTION MEPC.169(57) 

Adopted on 4 April 2008 

PROCEDURE FOR APPROVAL OF BALLAST WATER MANAGEMENT 

SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES (G9) 

THE MARINE ENVIRONMENT PROTECTION COMMITTEE, 

RECALLING Article 38(a) of the Convention on the International Maritime Organization 

concerning the functions of the Marine Environment Protection Committee conferred upon it by 

the international conventions for the prevention and control of marine pollution, 

NOTING that regulation D-3.2 of the International Convention for the Control and 

Management of Ships’ Ballast Water and Sediments, 2004 provides that ballast water 

management systems that make use of Active Substances or Preparations containing one or more 

Active Substances used to comply with this Convention, shall be approved by the Organization 

based on a Procedure developed by the Organization, 

NOTING ALSO resolution MEPC.126(53) by which the Committee adopted the 

Procedure for Approval of ballast water management systems that make use of Active 

Substances (G9), 

NOTING FURTHER that by resolution MEPC.126(53), the Committee resolved to keep 

the Procedure (G9) under review in the light of experience gained, 

 HAVING CONSIDERED, at its fifty-seventh session, the recommendation made by the 

Ballast Water Review Group, 

1. ADOPTS the revised Procedure for approval of ballast water management systems that 

make use of Active Substances (G9), as set out in the Annex to this resolution; 

2. INVITES Member Governments to give due consideration to the revised Procedure (G9) 

when evaluating ballast water management systems that make use of Active Substances before 

the submission of proposals for approval to the Committee; 

3. AGREES to keep the revised Procedure (G9) under review in the light of experience 

gained; 

4. URGES Member Governments to bring the aforementioned Procedure to the attention of 

manufacturers of ballast water management systems and other parties concerned with a view to 

encouraging its use; 

5. REVOKES the Procedure adopted by resolution MEPC.126(53).
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ANNEX 

PROCEDURE FOR APPROVAL OF BALLAST WATER MANAGEMENT 

SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES (G9) 

Contents 

1 INTRODUCTION 

2 DEFINITIONS 

3 PRINCIPLES 

4 GENERAL REQUIREMENTS 

 Identification 

 Data-set for Active Substances and Preparations 

 Assessment report 

5 RISK CHARACTERIZATION 

 Screening for persistency, bioaccumulation and toxicity 

 Toxicity testing of the treated ballast water 

 Risk characterization and analysis 

6 EVALUATION CRITERIA 

 Ship and personnel safety 

 Environmental protection 

7 REGULATION OF THE USE OF ACTIVE SUBSTANCES AND PREPARATIONS 

Handling of Active Substances and Preparations 

Hazard documentation and labelling 

Procedures and use 

8 APPROVAL 

Basic Approval 

Final Approval 

Notification of approval 

 Modification 

 Withdrawal of approval 

Appendix Approval Scheme for Active Substances or Preparations and ballast water 

management systems that make use of Active Substances 
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PROCEDURE FOR APPROVAL OF BALLAST WATER MANAGEMENT 

SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES (G9) 

1 INTRODUCTION 

1.1 This procedure describes the approval and withdrawal of approval of ballast water 

management systems that make use of Active Substances to comply with the Convention and 

their manner of application as set out in regulation D-3 of the “International Convention for the 

Control and Management of Ships’ Ballast Water and Sediments”. The Convention requires that 

at withdrawal of approval, the use of the relevant Active Substance or Substances shall be 

prohibited within 1 year after the date of such withdrawal. 

1.2 To comply with the Convention, ballast water management systems that make use of 

Active Substances or Preparations containing one or more Active Substances shall be approved 

by the Organization, based on a procedure developed by the Organization. 

1.3 The objective of this procedure is to determine the acceptability of Active Substances and 

Preparations containing one or more Active Substances and their application in ballast water 

management systems concerning ship safety, human health and the aquatic environment. 

This procedure is provided as a safeguard for the sustainable use of Active Substances 

and Preparations. 

1.4 This procedure is not intended for the evaluation of the efficacy of Active Substances. 

The efficacy of ballast water management systems that make use of Active Substances should be 

evaluated in accordance with the Guidelines for approval of ballast water management systems (G8). 

1.5 The goal of the procedure is to ensure proper application of the provisions contained in 

the Convention and the safeguards required by it. As such the procedure is to be updated as the 

state of knowledge and technology may require. New versions of the procedure will be 

circulated by the Organization following their approval. 

2 DEFINITIONS 

2.1 For the purposes of this procedure, the definitions in the Convention apply and: 

.1 “Active Substance” means a substance or organism, including a virus or a fungus 

that has a general or specific action on or against harmful aquatic organisms and 

pathogens. 

.2 “Ballast Water Discharge” means the ballast water as would be discharged 

overboard. 

.3 “Preparation” means any commercial formulation containing one or more Active 

Substances including any additives. This term also includes any Active 

Substances generated onboard for purposes of ballast water management and any 

relevant chemicals formed in the ballast water management system that make use 

of Active Substances to comply with the Convention. 
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.4 “Relevant Chemicals” means transformation or reaction products that are 

produced during and after employment of the ballast water management system in 

the ballast water or in the receiving environment and that may be of concern to the 

ship’s safety, aquatic environment and/or human health. 

3 PRINCIPLES 

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 Any system which makes use of, or generates, Active Substances, Relevant Chemicals or 

free radicals during the treatment process to eliminate organisms in order to comply with the 

Convention should be subject to this Procedure. 

3.4 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. 

3.5 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. 

3.6 Administrations should check the quality and completeness of any Basic Approval or 

Final Approval submission, against the latest version of the Methodology for information 

gathering and the conduct work of the Technical Group agreed by the Organization, prior to its 

submission to the MEPC. 

4 GENERAL REQUIREMENTS 

4.1 Identification 

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 on board. 

A chemical identification should be provided for any Relevant Chemicals. 
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4.2 Data-set for Active Substances and Preparations 

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: 

.1 Data on effects on aquatic plants, invertebrates, fish, and other biota, including 

sensitive and representative organisms: 

• acute aquatic toxicity; 

• chronic aquatic toxicity; 

• endocrine disruption; 

• sediment toxicity; 

• bioavailability/biomagnification/bioconcentration; and 

• food web/population effects. 

 .2 Data on mammalian toxicity: 

• acute toxicity; 

• effects on skin and eye; 

• chronic and long-term toxicity; 

• developmental and reproductive toxicity; 

• carcinogenicity; and 

• mutagenicity. 

.3 Data on environmental fate and effect under aerobic and anaerobic conditions: 

• modes of degradation (biotic; abiotic); 

• bioaccumulation, partition coefficient, octanol/water coefficient; 

• persistence and identification of the main metabolites in the relevant media 

(ballast water, marine and fresh waters); 

• reaction with organic matter; 

• potential physical effects on wildlife & benthic habitats; 

• potential residues in seafood; and 

• any known interactive effects. 

.4 Physical and chemical properties for the Active Substances and Preparations and 

the treated ballast water, if applicable: 

• melting point; 

• boiling point; 

• flammability; 

• density (relative density); 

• vapour pressure, vapour density; 

• water solubility / dissociation constant (pKa); 

• oxidation/reduction potential; 

• corrosivity to the materials or equipment of normal ship construction; 

• autoignition temperature; and 

• other known relevant physical or chemical hazards. 

.5 Analytical methods at environmentally relevant concentrations. 
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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: 

.1 Both a Quality Management Plan (QMP) and a Quality Assurance Project Plan 

(QAPP). Guidance on preparation of these plans, along with other guidance 

documents and other general quality control information are available for 

download from the International Organization for Standardization (ISO) 

(www.iso.org). 

.2 The QMP addresses the quality control management structure and policies of the 

Test Organization (including subcontractors and outside laboratories). 

.3 The QAPP is a project specific technical document reflecting the specifics of the 

system to be tested, the test facility, and other conditions affecting the actual 

design and implementation of the required experiments. 

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 Assessment report 

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 RISK CHARACTERIZATION 

5.1 Screening for persistency, bioaccumulation and toxicity 

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). 

 

1

 Preferably Organization for Economic Co-operation and Development (OECD) Guidelines for Testing of 

Chemicals (1993) or other equivalent tests. 
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.1 Persistence tests: 

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 relevant 

chemicals. 

.2 Bioaccumulation tests: 

The assessment of the (potential for) bioaccumulation should use measured 

bioconcentration factors in marine (or freshwater) organisms. Where these tests 

are not applicable, or if logPow <3, Bio Concentration Factor (BCF) values may 

be estimated using (Quantitative) Structure-Activity Relationship ((Q)SAR) 

models. 

.3 Toxicity tests: 

Acute and/or chronic ecotoxicity data, ideally covering the sensitive life stages, 

should in principle be used for the assessment of the toxicity criterion. 

5.2 Toxicity testing of the treated ballast water 

5.2.1 Toxicity testing is necessary for the Active Substance, or Preparations (see sections 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: 

.1 For the Basic Approval process, the discharge testing should be performed in a 

laboratory using techniques and equipment to simulate ballast water discharge 

following treatment by the Preparation. 

.2 For Final Approval, the discharge testing should be performed as part of the 

land-based type approval process using the treated ballast water discharge. 

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 
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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. 

5.2.8 Information on Total Residual Oxidants (TRO) and Total Residual Chlorine (TRC) should 

be provided as part of the application for evaluation, for both the ballast water treatment process 

and the ballast water discharge. 

5.3 Risk characterization and analysis 

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. 
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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. 

 

3

 Such as relevant OECD guidelines or equivalent. 
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6 EVALUATION CRITERIA 

The Organization should evaluate the application for approval based on the criteria in 

this section. 

6.1 The information that has been provided should be complete, of sufficient quality and in 

accordance with this Procedure. 

6.2 That this information does not indicate possible unacceptable adverse effects to 

environment, human health, property or resources. 

6.3 Ship and personnel safety 

6.3.1 In order to protect the ship and personnel safety the Technical Group should evaluate the 

physical and chemical hazards (see paragraph 4.2.1.4) to ensure that potential hazardous 

properties of the Active Substances, Preparations or Relevant Chemicals formed in the treated 

ballast water should not create any unreasonable risk to the ship and personnel. Proposed 

procedures for the use and technical equipment introduced needs to be taken into account. 

6.3.2 For the protection of personnel involved in the handling and storage of the 

Active Substances and Preparations, the proposal should include relevant ((M)SDS). 

The Organization should evaluate (M)SDS, mammalian toxicity data and chemical properties 

hazards (see paragraphs 4.2.1.2 and 4.2.1.4) and ensure that potential hazardous properties of the 

Active Substances, Preparations or Relevant Chemicals should not create any unreasonable risk 

to the ship or personnel. This evaluation should take into account the different circumstances 

that a ship or personnel may face in its trade (e.g., ice, tropical, humidity, etc.). 

6.3.3 A Human Exposure Scenario (HES) should be provided by the applicant as part of the 

Risk Assessment procedure for ballast water management systems. 

6.4 Environmental protection 

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. 
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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. 

7 REGULATION OF THE USE OF ACTIVE SUBSTANCES AND PREPARATIONS 

7.1 Handling of Active Substances and Preparations 

7.1.1 The proposal for approval of Active Substances and Preparations should include 

information on their intended use and application. The quantity of Active Substances and 

Preparations to be added to the ballast water and the maximum allowable concentration of the 

Active Substances therein should be described in the instructions provided by the manufacturer. 

The system should ensure that the maximum dosage and maximum allowable discharge 

concentration are not exceeded at any time. 

7.1.2 An assessment should be undertaken to ensure the safe on-board handling and storage of 

chemicals used to treat ballast water, using the existing IMO Conventions, Codes and guidance 

as a basis. 

7.2 Hazard documentation and labelling 

7.2.1 The proposal should include ((M)SDS) as required. The (M)SDS should describe 

appropriate storage and handling together with the effects of degradation and chemical reactivity 

during storage and should be included in the instructions provided by the manufacturer. 

7.2.2 Documentation of hazards or the (M)SDS 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 Procedures and use 

7.3.1 Detailed procedures and information for safe application of Active Substances and 

Preparations on board should be developed and supplied, taking into consideration existing IMO 

Conventions, Codes and guidance. The procedures should comply with the approval conditions 

such as maximum allowable concentration and maximum discharge concentration, if any. 
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8 APPROVAL 

8.1 Basic Approval 

8.1.1 All proprietary data should be treated as confidential by the Organization and its 

Technical Group, the Competent Authorities involved, and the evaluating regulatory scientists, 

if any. However, all information related to safety and environmental protection, including 

physical/chemical properties, environmental fate and toxicity, should be treated as 

non-confidential. 

8.1.2 Procedure to be followed: 

.1 The manufacturer should evaluate the Active Substances or Preparations and the 

potential discharge in accordance with the approval criteria specified in 

this procedure. 

.2 Upon completion, the manufacturer should prepare an Application on the Active 

Substances and Preparations and submit it to the Member of the Organization 

concerned. An application should only be made once the ballast water 

management system, Active Substance or Preparation has been sufficiently 

designed, progressed and tested to provide the full data necessary for a 

Basic Approval. 

.3 The Administration having received a satisfactory application should as soon as 

possible propose an approval to the Organization. 

.4 Members of the Organization may propose an approval. 

.5 The Organization should announce and set the time frame for the evaluation of 

Active Substances and Preparations. 

.6 Parties, Members of the Organization, the United Nations and its Specialized 

Agencies, intergovernmental organizations having agreements with the 

Organization and non-governmental organizations in consultative status with the 

Organization may submit information that is relevant to the evaluation. 

.7 The Organization should establish a Technical Group in accordance with its rules 

of procedure ensuring that proprietary data should be treated as confidential. 

.8 The Technical Group should review the comprehensive proposal along with any 

additional data submitted and report to the Organization whether the proposal has 

demonstrated a potential for unreasonable risk for environment, human health, 

property or resources in accordance with the criteria specified in this procedure. 

.9 The Technical Group’s report should be in written form and circulated to the 

Parties, Members of the Organization, the United Nations and its Specialized 

Agencies, intergovernmental organizations having agreements with the 

Organization and non-governmental organizations in consultative status with the 

Organization, prior to its consideration by the competent Committee. 
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.10 The Committee of the Organization should decide whether to approve any 

proposal, introduce any modifications thereto, if appropriate, taking into account 

the Technical Group’s report. 

.11 The Member of the Organization that submitted the application to the 

Organization should inform in writing the applicant about the decision made with 

regard to the respective Active Substance or Preparation and their manner of 

application. 

.12 Active Substances or Preparations receiving Basic Approval by the Organization 

may be used for prototype or type approval testing based on the guidelines 

developed by the Organization4. Subject to evaluation against the criteria 

developed by the Organization, an Active Substance or Preparation may be used 

for Prototype or Type Approval testing for the approval of different BWMS. 

.13 An applicant seeking to take advantage of an Active Substance or Preparation’s 

Basic Approval should provide in its application a written agreement from the 

applicant whose Active Substance or Preparation has been granted the initial 

Basic Approval. 

8.2 Final Approval 

8.2.1 In accordance with regulation D-3.2, a ballast water management system using an Active 

Substance or Preparation to comply with the Convention (which received Basic Approval) must be 

approved by the Organization. For this purpose, the Member of the Organization submitting an 

application should conduct the Type Approval tests in accordance with Guidelines for approval of 

ballast water management systems (G8). The results should be conveyed to the Organization for 

confirmation that the residual toxicity of the discharge conforms to the evaluation undertaken for 

Basic Approval. This would result in Final Approval of the ballast water management system in 

accordance with regulation D-3.2. Active Substances or Preparations that have received 

Basic Approval by the Organization may be used for evaluation of ballast water management 

systems using Active Substances or Preparations for Final Approval. 

8.2.2 It is to be noted that from the Guidelines (G8) land-based testing only the results of the 

residual toxicity tests should be included in the proposal for Final Approval in accordance with 

Procedure (G9). All other Guidelines (G8) testing remains for the assessment and attention of 

the Administration. Although Basic Approval under Procedure (G9) should not be a 

pre-requisite of Type Approval testing, as an Administration can regulate discharges from its 

own ships in its own jurisdiction. Basic Approval would still be required, and the specific 

technology could not be used in vessels in another jurisdiction without Basic Approval. 

8.2.3 It should be noted that once a system has received Final Approval under this Procedure, 

then the respective applicant should not have to retrospectively submit new data if there is a 

change in the Methodology agreed by the Organization. 

 

4

 Guidelines for approval and oversight of prototype ballast water treatment technologies (G10) and Guidelines for approval 

of Ballast Water Management Systems (G8). 
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8.3 Notification of approval 

8.3.1 The Organization will record the Basic and Final Approval of Active Substances and 

Preparations and ballast water management systems that make use of Active Substances and 

circulate the list once a year including the following information: 

• Name of ballast water management system that make use of Active Substances 

and Preparations; 

• Date of approval; 

• Name of manufacturer; and 

• Any other specifications, if necessary. 

8.4 Modification 

8.4.1 Manufacturers should report any modifications in names, including trade and technical 

name, composition or use of the Active Substances and Preparations in the ballast water 

management systems approved by the Organization, to the Member of the Organization. 

The Member of the Organization should inform the Organization accordingly. 

8.4.2 Manufacturers intending to significantly change any part of a ballast water management 

System that has been approved by the Organization or the Active Substances and Preparations 

used in it should submit a new application. 

8.5 Withdrawal of approval 

8.5.1 The Organization may withdraw any approval in the following circumstances: 

.1 If the Active Substances and Preparations or ballast water management system 

that make use of Active Substances no longer conforms to requirements due to 

amendments of the Convention. 

.2 If any data or test records differ materially from data relied upon at the time of 

approval and are deemed not to satisfy the approval condition. 

.3 If a request for withdrawal of approval is made by the Member of the 

Organization on behalf of the manufacturer. 

.4 If unreasonable harm to environment, human health, property or resources is 

demonstrated by any Member of the Organization or observer to have been caused 

by the approved ballast water management system that make use of Active 

Substances or Preparations. 
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Appendix 

Approval Scheme for Active Substance or Preparation and Ballast Water 

Management systems that make use of Active Substances 

***

Manufacturer Only laboratory scale data is necessary, and discharge 

time is predicted in simplified dilution model 

The Member of the Organization 

IMO Technical Group 

Organization 

Using Active Substances that have received basic approval

Evaluate as confidential

Type Approval according to relevant IMO guidelines 

Dossiers of existing registration may be 

submitted 

Organization (MEPC)

Risk Characterization and Analysis 

Basic Approval by, and report to Organization 

For approved Active Substances the Organization 

circulates the list to the Parties 

Request for 

additional 

data set 

2. FINAL APPROVAL 

The Member of the Organization 

Manufacturer

Discharge test with whole 

system on the test-bed 

Submit

Submit application

Data set 

Discharge Test-data 

Discharge Time 

Etc. 

IMO Technical Group

Organization 

Organization (MEPC)

Request for 

additional 

data set 

The Member of the Organization 

The Member of the Organization 

Data set 

Discharge Test-data 

Discharge Time 

Confirm residual toxicity of discharged ballast water 

with the evaluation under the basic approval 

Approve the Ballast Water Management system that make 

use of Active Substances 

Publish list of approvals 

1. BASIC APPROVAL