I:\MEPC\54\2-12.doc 

For reasons of economy, this document is printed in a limited number. Delegates are 

kindly asked to bring their copies to meetings and not to request additional copies.

INTERNATIONAL MARITIME ORGANIZATION

IMO

E

MARINE ENVIRONMENT PROTECTION 

COMMITTEE 

54th session 

Agenda item 2 

MEPC 54/2/12

 28 February 2006

 Original: ENGLISH

HARMFUL AQUATIC ORGANISMS IN BALLAST WATER 

Report of the first meeting of the GESAMP-BWWG 

Note by the Secretariat 

SUMMARY

Executive summary: This document contains the report of the first meeting of the 

GESAMP Ballast Water Working Group (GESAMP-BWWG) 

including the evaluation of the proposals for approval of Active 

Substances submitted by Germany and the Republic of Korea 

Action to be taken: Paragraph 4 

Related document: MEPC 53/24 

1 MEPC 53 instructed the Secretariat to explore the possibility of establishing a technical 

group under the auspices of GESAMP to review the proposals for approval of Ballast Water 

Management systems that make use of Active Substances. Through sustained efforts and under 

significant time pressure, a GESAMP-Ballast Water Working Group was established and held its 

first meeting from 23 to 27 January 2006 to evaluate two submissions by Germany and the 

Republic of Korea. 

2 Although the Committee did not consider the non-confidential description of the 

technology by the Republic of Korea, as it was the case for Germany, the proposal for approval 

by the Republic of Korea was accepted for evaluation by the GESAMP-BWWG with the 

understanding that if submitted to MEPC 54 by the 13-week deadline will still leave four weeks 

for delegations to submit relevant information in time for the evaluation. 

3 It should be noted that, according to the estimates done by the GESAMP-BWWG, at least 

20 weeks are needed for the evaluation, production and submission of the report in accordance 

with the Committeesí Guidelines for submission of documents, with an additional 8 weeks for 

the preparation of the meeting. Members are, therefore, kindly requested to submit the 

non-confidential description of their methodologies to the session of MEPC before the one 

expected to be decided on Basic Approval, or at the earliest opportunity after, but not after the 

28 week deadline before the Basic Approval session of the Committee (see table in annex 2). 
MEPC 54/2/12 - 2 - 

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Action requested of the Committee 

4 The Committee is invited to take into account the report of GESAMP-BWWG when 

deciding on the Basic Approval for the two proposals and to consider the timeline contained in 

paragraph 3 for future submissions. 

*** 
MEPC 54/2/12 

I:\MEPC\54\2-12.doc 

ANNEX 1 

GESAMP-BALLAST WATER WORKING 

GROUP 

1st meeting 

GESAMP-BWWG 1/9

 20 February 2006

 Original: ENGLISH

REPORT OF THE FIRST MEETING OF THE 

GESAMP-BALLAST WATER WORKING GROUP 

Table of Contents 

Section Paragraph Nos. Page Nos.

 

1 INTRODUCTION ÖÖ..ÖÖÖÖÖ............................. 1.1 ñ 1.4 3 

2 ISSUES OF CONFIDENTIALITY Ö..ÖÖÖÖÖÖ... 2.1 ñ 2.3 3 - 4 

3 TERMS OF REFERENCE ÖÖ..ÖÖÖÖÖÖÖÖÖ 3.1 ñ 3.4 4 - 5 

4 DEVELOPMENT OF A DRAFT METHODOLOGY 

FOR INFORMATION GATHERING AND THE 

CONDUCT OF WORK OF GESAMP-BWWGÖ.. 4.1 ñ 4-16 5 ñ 7 

5 REVIEW OF PROPOSALS FOR APPROVAL OF 

ACTIVE SUBSTANCES ñ SUBMITTED BY 

GERMANY AND THE REPUBLIC OF KOREA ÖÖ. 5.1 ñ 5.10 7 - 10 

6 MATTERS ARISING FROM RECENT IMO 

ACTIVITIES ÖÖ..ÖÖÖÖÖÖÖÖÖÖÖÖÖÖ 6 10 

7 CONSIDERATION OF QUERIES FROM MEMBERS 

AND INDUSTRY ÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖ 7.1 ñ 7.2 10 - 11 

8 FUTURE WORK PROGRAMME AND TENTATIVE 

DATE FOR THE NEXT MEETING ÖÖÖ..ÖÖÖÖ 8.1 ñ 8.4 11 - 12 

9 CONSIDERATION AND ADOPTION OF THE 

REPORT ÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖ.. 9.1 ñ 9.4 12 
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ANNEXES 

ANNEX 1 LIST OF MEMBERS ATTENDING THE FIRST SESSION OF THE GESAMP 

BW WORKING GROUP 

ANNEX 2 AGENDA FOR THE FIRST SESSION OF THE BALLAST WATER 

WORKING GROUP OF GESAMP 

ANNEX 3 TERMS OF REFERENCE FOR THE GESAMP-BALLAST WATER 

WORKING GROUP 

ANNEX 4 DRAFT METHODOLOGY FOR INFORMATION GATHERING AND THE 

CONDUCT OF WORK OF GESAMP-BWWG 

ANNEX 5 REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES ñ 

SUBMITTED BY GERMANY (PERACLEAN OCEAN) 

ANNEX 6 REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES ñ 

SUBMITTED BY REPUBLIC OF KOREA (ELECTROCLEAN) 
MEPC 54/2/12 

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1 INTRODUCTION

GESAMP Ballast Water Working Group (GESAMP-BWWG) was held at IMO Headquarters, 

London, from 23 to 27 January 2006, under the chairmanship of Mr. Finn Pedersen. A list of 

members attending this first meeting is shown in annex 1, and the agenda, as approved by the 

Group, is set out in annex 2. 

1.2 Mr. RenÈ Coenen, IMO Technical Secretary of GESAMP, drew attention to the history, 

developments and merits of GESAMP as the advisory scientific and multi-disciplinary body 

within the United Nations system. Mr. Dandu Pughiuc, Head of the IMOís Office for Ballast 

Water Management, and the Secretary for this meeting, briefed the Group on resolution 

MEPC.126(53), which had been adopted in summer 2005, concerning the Procedure for 

Approval of Ballast Water Management Systems that make use of Active Substances (G9). 

Essentially, the approval procedure consists of two steps: 

• Basic approval: An Administration of a Member of the Organization may propose an 

approval of a Ballast Water Management System based on a satisfactory submission of a 

manufacturer developed in accordance with the (G9) and the further details of criteria as 

being developed by the GESAMP-BWWG. In principle, the basic approval allows the 

further development of the Ballast Water Management System through full-scale onboard ship development and testing. 

• Final approval: When full-scale on-board ship development and testing has been 

satisfactorily completed, the Member of the Organization may apply for a final approval 

of a Ballast Water Management System in accordance with Regulation D-3.2. 

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. 

When a final approval has been given and the respective Active Substance included in the IMO 

list, the respective Administration may issue the Type Approval Certificate in accordance with 

the guidelines developed by the Organization. 

1.3 GESAMP-BWWG was tasked to develop methodologies and information requirements 

for conducting its work and to review the proposals submitted by Governments of IMO Members 

for the approval of Active Substances in accordance with the Terms of Reference developed by 

the Committee and accepted by the GESAMP Inter-Secretariat. 

1.4 The Group considered its terms of reference and included some small amendments. The 

terms of reference, as agreed by the Group, are shown at annex 3. 

2 ISSUES OF CONFIDENTIALITY 

2.1 Applications for Basic Approval regarding the use of Active Substances had been 

submitted by two members of the Organization, namely, Germany and the Republic of Korea. 
MEPC 54/2/12 

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The Secretariat informed the Group that part of the information packages submitted by Maritime 

Administrations of IMO Members was ìnon-confidentialî and was considered for submission to 

MEPC 54. The Secretariat further emphasized that members of this Group were obliged to keep 

relevant data of the submission confidential to protect the commercial interests of the producing 

companies. The Group suggested that, after completion of the approval procedure, the following 

data and information should no longer be regarded as confidential: 

• The name and address of the applicant 

• The names and addresses of the manufacturers of the Active Substance and/or the 

preparation (if different) 

• The names and content of the Active Substance(s) in the preparations and the name of the 

preparation 

• The names of other substances which are regarded as dangerous according to the 

UN GHS or relevant IMO regulations and contribute to the hazard documentation of the 

preparation 

• Physical and chemical data concerning the Active Substance and preparation 

• A summary of the results of the tests required pursuant to Section 4.2 of the Procedure to 

establish the effects of the substance(s) or preparation(s) on humans and the environment 

• Recommended methods and precautions against dangers resulting from handling, storage, 

transport and fire 

• Any means of rendering the active substance or preparation harmless 

• Safety data sheets 

• Methods of chemical analysis 

• Methods of disposal of the product and of its packaging 

• Procedures to be followed and measures to be taken in the case of spillage or leakage 

• First aid and medical advice to be given in the case of injury to persons. 

2.2 In evaluating an application, the Group reserves its right to base its evaluation on any 

available information and to use this information for justifying its conclusions and 

recommendations in its evaluation reports irrespective of confidentiality issues. However, the 

Group would recommend that the Organization prior to submission of the Groups evaluation 

report to the MEPC consults with the Member of the Organization having proposed the Ballast 

Water Management System. In cases where the evaluation report contains confidential 

information, the Organization should decide on the future procedures. 

2.3 In case there were requests to IMO for more information regarding an application, the 

Organization would provide the name and address of the responsible national administration 

which originally submitted the application for the Basic Approval. It could then respond, as it 

feels appropriate. 

3 TERMS OF REFERENCE 

3.1 An expanded version of the Terms of Reference had been proposed to the 

GESAMP-Ballast Water Working Group. The Group, at its first session, reviewed the expanded 

form and introduced some small amendments. The expanded version, as adopted, is shown in 

annex 3. GESAMP is invited to confirm the Terms of Reference as annexed to this report. 
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3.2 When considering its Terms of Reference, the Group noted the disproportionality 

between the resources available for the approval system developed for Ballast Water 

Management Systems that make use of Active Substances and the far more comprehensive 

international authorization systems for biocides and pesticides. International authorization 

systems for biocides and pesticides make use of detailed guidance documents developed through 

years of experience. The evaluation of risks to human health and the environment is a process 

that requires substantial resources from the authorizing administrations. 

3.3 Consequently, the Group considered it overly optimistic to expect that a well elaborated 

draft methodology for information gathering and conduct of work of the GESAMP-Ballast Water 

Working Group could be developed during the few meeting days available, as well as thorough 

evaluations of proposals for approval of two applications regarding Active Substances. 

3.4 The Group also suggested that MEPC may wish to look further into the Procedure for 

approval of the use of Ballast Water Management systems that make use of Active Substances, 

with a view to aligning the evaluation procedures and the levels of ambition with similar 

international systems for authorization of the use of toxic chemicals as, e.g., biocides and 

pesticides. 

4 DEVELOPMENT OF A DRAFT METHODOLOGY FOR INFORMATION 

GATHERING AND THE CONDUCT OF WORK OF GESAMP-BWWG 

4.1 The Group noted that the MEPC ìProcedure for approval of ballast water management 

systems that make use of active substances (G9)î would form the basis for its work. In addition, 

the submission of the European Commission MEPC 54/2/1 to MEPC 54 was seen as useful 

guidance in defining the approaches for evaluation of proposals for approval of Active 

Substances. 

4.2 Prior to the meeting, the Secretariat had developed and circulated a first draft of a ìDraft 

Methodology for Information Gathering in Accordance with the Procedure for Ballast Water 

Management Systems that make use of Active Substances (G9)î, which was based on the two 

aforementioned documents. The Group appreciated the work done and considered the document 

as a good starting point for the further development of the methodology requested. 

4.3 However, in discussing the possible approaches, the Group also noted a number of 

apparent inconsistencies in Procedure (G9). 

4.4 Some of the data required for preparation (mixtures of substances) according to (G9) 

were seen as inappropriate. These include partition coefficients, biodegradation and 

bioaccumulation data, as it is the individual substances in the preparation that may, or may not, 

degrade or accumulate rather than the preparation itself. 

4.5 The Group considered the appropriateness of conducting long-term (chronic) toxicity 

testing with preparations and treated ballast water and concluded that this would have to be 

considered on a case-by-case basis. In general, when a complex mixture is released to the aquatic 

environment, the individual substances in the mixture will most likely behave differently 

(i.e. some substances may degrade, some may sorb to particulate matter, some may evaporate, 

etc.) and after a short time, the organisms in the environment will not be exposed to the original 

mixture any more. Therefore, only in cases where the use results in very frequent releases to the 

same environment from different ships and where organisms in the environment therefore may 

be frequently exposed to treated ballast water, an assessment based on long-term testing of the 

preparation and/or the treated ballast water may be appropriate. In cases where only infrequent 
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releases take place, an assessment based on the long-term testing of the individual substances in 

the preparation would be more useful. 

4.6 The Group discussed various approaches for structuring the draft methodology. Although 

a structure reflecting the sequential order of assessment of the hazards and risks to the ship, the 

crew and the aquatic environment might have been preferred, the Group considered that the 

structure of Procedure (G9) should be followed. This was further emphasized by the fact that the 

Group was informed that several applications were under development in various Member States 

(cf. agenda item 8). 

4.7 It is the intention that the draft methodology should serve two purposes. On the one hand, 

it should be guidance to applicants on what to consider in their development of a dossier for the 

Ballast Water Management system using Active Substances. On the other hand, it should also be 

guidance to the Group in its evaluation and review of applications. The Group further noticed 

that, for the moment, the guidance is mainly intended to relate to dossiers submitted for basic 

approval. Furthermore, the Group considered that a submission for final approval could probably 

not be standardized, as a basic approval on a case-by-case basis might include preconditions that 

need to be addressed during the full-scale development and testing and eventually reported in 

connection with the application for the final approval. 

4.8 The draft methodology developed by the Group is attached as annex 4. MEPC is invited 

to comment on the draft and review its contents, as appropriate. 

4.9 The Group recommends that future applications for basic approval of a Ballast Water 

Management System should be prepared in accordance with the methodology proposed by the 

Group (cf. Annex IV) in order to ensure the completeness of the application and to facilitate the 

Groupís work. 

4.10 In addition, for future applications, the applicant is requested to complete a key data 

summary table to enable the Group to have an overview of the properties of the product. A blank 

key data summary table has been developed by the Group for this purpose and is included in 

annex 4. 

4.11 The assessment of the potential risks to the environment basically requires that a 

Predicted Environmental Concentration (PEC) can be established and compared to a Predicted 

No-Effect-Concentration (PNEC). When the PEC does not exceed the PNEC, it is considered 

likely that no unacceptable toxic effects will occur. 

4.12 In discussing possible scenarios for discharge of treated ballast water to the aquatic 

environment, the Group realised that information was not available on basic assumptions 

regarding the likely volume of treated ballast water, the duration and frequency of discharge, and 

the dimensions of the receiving aquatic environment including area, water volume, water flow, 

etc. Therefore, the Group considered the need to develop a generic Emission Scenario Document 

(ESD) on ballast water in a way similar to the ESDs, developed by the OECD, on antifouling 

paints as well as multiple other ESDs for various product types developed by the OECD, EU and 

USA. A development of the most likely scenario, both short- and long-term, for discharge of 

treated ballast water including documentation of appropriate models is needed. Considering the 

efforts needed for developing such ESDs, the Group decided that development of an ESD for 

ballast water would not be possible within the very limited time available. Instead the Group 

recommends MEPC to initiate such a development, which pertains to all Ballast Water 

Management systems and is seen as crucial for a thorough evaluation of the environmental risks 

of discharge of ballast water. 
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4.13 The Group also notes that several assessment factors (the value used to determine the 

PNEC from the no-effect concentration determined experimentally) are currently in international 

use. The Group intends to discuss assessment factors at the next meeting. 

4.14 Section 2.3 of the Terms of Reference for the Group gives a mandate to assess the risk to 

crew safety. The Group therefore thinks that the applicant should be required to provide a 

preliminary assessment of risks to ship, crew and the environment, which is not a requirement 

stated in the Procedure (G9). 

4.15 The Group considered that toxicity of treated ballast water at discharge needs special 

attention. Usually, 100% ballast water will contain active ingredients above the LC50 of the most 

sensitive species. The risk assessment requires the use of a dilution factor (the amount of 

short-term dilution that occurs as the ballast water enters the aquatic environment) in order to 

conclude that products may be used safely. The Group was unsure as to whether the intention of 

MEPC was to prevent the use of products that required the use of a dilution factor to reach a 

favourable conclusion in the risk assessment. The Group requested clarification of this issue from 

MEPC. 

4.16 The Group took note of the intention to limit the effects to the environment as much as 

possible, based on the requirement of the PEC/PNEC ratio < 1 as an initial analysis, but the 

Group recommends the development of a tiered system in which an appropriate risk assessment 

may show that the substance can be safely applied without unacceptable risks to the environment. 

5 REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES - 

SUBMITTED BY GERMANY AND THE REPUBLIC OF KOREA 

Submission by Germany 

5.1 The Group evaluated the application dossier submitted by Germany on the use of 

Peraclean Ocean as a biocide for treatment of ballast water. In doing so, the Group noticed that 

despite the voluminous application dossier, some information is missing which prevented a full 

evaluation of possible risks to ship, crew and the environment: 

• A detailed description of the intended application on board ships allowing an evaluation 

of the safety to ship and crew. 

• Data on realistic occupational exposure scenarios required in order to characterize human 

health risk of use and handling. 

• Justification for use of scenarios for modelling environmental exposure concentrations 

and assumptions and details of the modelling; 

• Tests with treated ballast water on more species, including long-term data. 

• Justification for non-submission of data in cases where the data requirements of G9 are 

not fulfilled. 

• The application dossier does not include documentation of the quality-control/qualityassurance programme as requested in Procedure (G9): 4.2.4. 
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5.2 In evaluating the application, a number of concerns were raised regarding risks to both 

ship, the crew and the environment that did not allow that the Group would recommend an onboard ship testing to be conducted before further studies have been conducted. The matters of 

concern were: 

• Peraclean Ocean and the components of the preparation possess some toxicological 

properties, such as, irritation and corrosiveness that may cause a risk to the ship and its 

crew, if not managed properly because of the specific hazards associated with storage and 

use on board ship (e.g. movement of ship, venting of gases from the product, control of 

temperature, corrosion). 

• A number of concerns in relation to safety of ships have been raised due to the 

physicochemical hazards of Peraclean Ocean. These concerns need to be addressed prior 

to initiation of full-scale testing on board ships. The Group recommended, as mandatory, 

the application of RMM (risk management measures) for the protection of the potentially 

exposed populations (mainly the crew) to the main routes of concern: dermal and 

inhalation. These control measures (Personal Protective Equipment - PPE and Respiratory 

Protective Equipment - RPE) should be described and implemented, and must be put in 

place for use and handling of the preparation at the different stages of the process and 

with the different concentrations applied. 

5.3 After a careful evaluation of the available information, the Group recommended that a 

basic approval be issued allowing a further land-based development and testing. During this 

phase, the above-mentioned concerns should be considered. Only when the development of the 

technology and further assessment of risks to ship, crew and the environment have been 

completed to the satisfaction of the respective Administration should a full-scale on-board testing 

be initiated. 

5.4 Before a final approval can be issued, a number of issues need to be investigated and 

concluded on. These include: 

• The Group recommended that dermal and inhalation sub-chronic effects raised in some 

studies should be further investigated, taking into account realistic occupational exposure 

scenarios and covering non-accident situations. These data should be submitted before 

final approval. The irritation effects in the respiratory tract triggered should be further 

investigated in a repeated-dose inhalation study in order to assess the toxicity of the 

substance at lower dose exposure. Additionally, a dermal absorption study in vitro with 

intact skin at lower doses (diluted concentrations) should be conducted to anticipate the 

risk of occupational exposure in non accidental situations. 

• Insufficient information was available on the likely composition and aquatic toxicity of 

ballast water after treatment and this needed to be studied. 

• There seems to be insufficient information on degradation of components of Peraclean 

Ocean, particularly hydrogen peroxide, during treatment of ballast water as it seems to 

depend on the content of organics and particles in ballast water. This should be further 

studied and reliable estimates or measurements of concentrations of the components at 

discharge should form the basis for the environmental risk assessment. 

• Exposure modelling has been performed using the MAMPEC model. The assumptions on 

the scenarios as well as input parameters of the model are not presented in detail, which 

hinders the evaluation of the reliability of the model results. The Group would require 
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access to the input data and more information on the parameters within the model in order 

to ascertain the validity of the results. Justification for the use of the models needs to be 

provided. 

• Based on the updated information, a revised environmental risk assessment needs to be 

submitted for a final approval. 

5.5 The evaluation report is included as annex 5 to this report. 

Submission by the Republic of Korea 

5.6 The Group evaluated the application dossier submitted by Republic of Korea (ROK) on 

the ELECTRO CLEAN system (ECS) as a possible methodology for treatment of ballast water. 

In doing so, the Group noticed that the dossier does not live up to the basic requirements as 

specified in the (G9) Procedure. In particular, the following information is missing: 

• Effects of the maximum total residual chlorine (TRC) concentration (20-30 mg/l) and also 

a quantitative risk assessment to the environment. 

• Information on the reliability and accuracy of the control scheme. 

• The dossiers do not provide any data on the corrosivity of the treated ballast water. 

• Data on human exposure to the active substances not allowing risk evaluation of use and 

handling. 

• Justification of non submission of data. 

• Calculation of the predicted environmental concentration (PEC) in the dossier and in 

document MEPC 54/2/3 are based on the MAMPEC modelling from the German 

application. The Group had several comments to the MAMPEC model results and further 

pointed out that to use these without access to the input data does not produce any 

valuable data. The calculated PEC values are therefore only used as indicative estimates 

in this assessment. 

• The application dossier does not include documentation of the quality control/quality 

assurance programme as requested in Procedure (G9): 4.2.4. 

5.7 In evaluating the application, a number of concerns were raised regarding risks to both 

ship, the crew and the environment that did not allow that the Group would recommend an onboard ship testing to be conducted before further studies have been conducted. The matters of 

concern were: 

• Mitigation procedures or operations should be established to reduce the total residual 

chlorine (TRC) to levels that avoid risk to the environment in the case of short trips and 

during the treatment of clean waters where the toxicity half-life seems to be longer. It 

seems that the application of the ECS leads to creation of substantial amounts of very 

reactive species, in particular chlorine solutions, that may result in increased corrosion of 

the tank and piping. The potential damage to the ship has not been described. 

• The amounts of total residual chlorine (TRC) formed during the electrolytic process result 

in concentrations in the treated ballast water that largely exceed limit values established 

for discharge of waste water from land-based point sources. The degradation rate of TRC 

is so low that substantial concentrations may be expected also at discharge of treated 

ballast water. In addition, the potential health risk that may arise from human/mammalian 

exposure to chlorinated by-products have not been sufficiently characterized. 
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• The formation of chlorinated and brominated by-products is not sufficiently described. 

The Group is aware that plenty of studies have been conducted on formation of such 

products and their environmental risks during electrolytic processes and during 

chlorination. This needs to be further studied. 

• Acute aquatic toxicity tests have been conducted with sea water to different species 

immediately after treatment with ECS. The tests showed that a dilution of up to more than 

100 times is required before acute toxicity can be avoided. The degradation of toxicity in 

the ballast water prior to discharge and the likely toxicity at discharge should be further 

studied. 

• Exposure modelling has been performed using the MAMPEC model. The assumptions on 

the scenarios as well as input parameters of the model are not presented in detail, which 

hinders the evaluation of the reliability of the model results. The Group would require 

access to the input data and more information on the parameters within the model in order 

to ascertain the validity of the results. Justification for the use of the models needs to be 

provided. 

• An aquatic risk assessment based on measured concentrations in treated ballast water, 

assuming a dilution of approximately 2,000 times and derived Predicted No-EffectConcentrations for hypochlorite, showed a risk to the aquatic environment. 

• The dossier does not include documentation of which substances are produced in a 

possible fresh water application. A full documentation of their properties should be 

included. 

• Further land-based studies should be conducted to address the concerns for short- and 

long-term impacts to the receiving waters before initiating before on-board testing takes 

place. 

5.8 After a careful evaluation of the available information, the Group recommended that a 

basic approval be issued allowing a further land-based development and testing. During this 

phase, the above-mentioned concerns should be considered. Only when the development of the 

technology and further assessment of risks to ship, crew and the environment have been 

completed to the satisfaction of the respective Administration should a full-scale on-board testing 

be initiated. 

5.9 Before a final approval can be issued, the risks to ship, crew and the environment need to 

be further investigated and reported on based on the issues mentioned above and any other 

information that is obtained during the further development work. 

5.10 The evaluation report is included as annex 6 to this report. 

6 MATTERS ARISING FROM RECENT IMO ACTIVITIES 

 The Group noted that the Administrations of Sweden, Japan and Singapore have indicated 

their intention to submit proposals for a basic approval of Active Substances during the coming 

months. The Group agreed to take this information into account when considering its future 

programme under agenda item 8. 
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7 CONSIDERATION OF QUERIES FROM MEMBERS AND INDUSTRY 

7.1 The Group noted the list of queries put forward by Member States as follows: 

.1 Should Basic Approval preclude land-based testing? 

.2 If Land-based testing has been conducted before receiving basic approval, should 

they be conducted again after the basic approval has been granted? 

.3 Can the Administration decide on the order of the land-based testing, request for 

basic approval and shipboard testing? 

.4 Is the Type Approval Certificate for Ballast Water Management systems that use 

Active Substances issued by the National Administration or by IMO? 

7.2 The Group offered the following views: 

 .1 Conducting land-based testing would enhance the knowledge on a particular 

ballast water management system, and is a practical way to initiate the research. It 

was also felt that land based testing should normally be conducted in accordance 

with national regulations and standards. The Group further noted that there was no 

follow-up range of testing on land or on board ship that could be advised. The 

more results from testing, even from different locations, became available, the 

easier it was to establish a proper risk assessment regarding potential effects on 

board and in coastal areas. 

 .2 The Group believed that the queries referring to a procedural aspect (7.1.2 to 

7.1.4) may need to be referred to MEPC. The Group felt that this matter was 

beyond its area of expertise. 

8 FUTURE WORK PROGRAMME AND TENTATIVE DATE FOR THE NEXT 

MEETING 

8.1 Based on the first experience with the evaluation of proposals for approval of Active 

Substances submitted by IMO Members, the Group considers that a greater effort should be 

undertaken in securing that the ëapplication dossierí was complete and that it conformed to the 

basic requirements of Procedure (G9). If such basic requirements are not fulfilled, it may reduce 

the evaluation capacity of the Group and, in worst cases, it might prevent that the evaluation of a 

proposal be concluded. 

8.2 The Group also noted that the approval system was a new activity of the Organization and 

its members and that it was necessary to gain practical experience and to adapt the system 

accordingly in order to create a well functioning system. 

8.3 The Group further noted that the lack of guidance to applicants on the development of 

application dossiers for ballast water treatment systems had resulted in the two applications 

considered at this first meeting lacking important information. This had caused major difficulties 

for the Group in its evaluation of possible risks to ships, crew and the environment. The 

conclusions of the Group should be seen in this context. 
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8.4 The Group noted the following points for future work: 

• A thorough risk assessment needs to be included in the application dossier specifying the 

used scenarios, the relevant exposures of crew and the environment, and the potential 

effects and risks. 

• The Maritime Administrations of the member states should evaluate and be satisfied with 

the state of the dossiers for compliance with Procedure (G9) and available guidance 

before submission to the Group. 

• The Group may need an additional expert in mammalian toxicology 

• The Group has a limited capacity for processing applications within the timeframe 

specified for the activity of the Group. Provided that the above conditions are fulfilled, 

the Group finds it possible to evaluate two to three application dossiers for basic approval 

per meeting (5 working days). There is potential for greater capacity once the 

methodology has been developed and is being used by applicants. However, the Group 

wants to reiterate once again that the level of detail in assessment under the proposed 

conditions is far below a scientifically satisfactory level as currently practised in similar 

international authorisation schemes. 

• The Group would find it useful to have a contact within the applicant company to whom 

technical questions could be addressed during the Groupís meeting, particularly relating 

to the ballast water management system. 

9 CONSIDERATION AND ADOPTION OF THE REPORT 

9.1 The Group adopted the report and the Chairman thanked the members of the Group for 

their efforts. 

9.2 At the conclusion of this first session, Mr. J.-C. Sainlos, Director of the Marine 

Environment Division of the Organization and Administrative Secretary of GESAMP thanked 

the Chairman and the members of the working Group for their efforts. Noting the proposal of the 

Group that additional expertise in human toxicology was needed to facilitate its future work, the 

Secretariat would look into this matter. 

9.3 The Group agreed that its next session should tentatively be held 22-26 May 2006 to 

allow sufficient time for the evaluation, production of the report and submission to MEPC in 

accordance with the Guidelines on organization and method of work of the Committee 

(MSC/Circ.1099, MEPC/Circ.405). 

9.4 The Chairman closed this session on Friday, 27 January 2006 at 14:00 hours. 

* * * 
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ANNEX 1 

LIST OF MEMBERS ATTENDING THE FIRST SESSION 

OF THE GESAMP BW WORKING GROUP 

Mr. Finn Pedersen (Chairman) 

Special Adviser 

Danish Environmental Protection Agency 

Chemicals Unit 

Strandgade 29 E-mail: fpe@mst.dk 

DK-1401 Copenhagen Tel: +45 32 660289 

Denmark 

Ms. Teresa Borges 

Senior Technical Officer 

General Health Directorate 

Alameda D. Afonso Henriques, 45 

P-1049-005 Lisbon E-mail: tborges@dgsaude.min-saude.pt 

Portugal Tel: +351 218430593 

Mr. Egil Dragsund 

Principal Marine Biologist 

Environmental and Technical Solutions 

Det Norske Veritas AS E-mail: egil.dragsund.dnv.com 

Veritasveien1 Tel: +47 67 57 8894 

NO- 1322 H ̄vik Fax: +47 67 57 9911 

Norway Mobile: +47 97 02 6956 

Mr. Shinichi Hanayama 

Senior Research Fellow 

Maritime Technology Department 

Ocean Policy Research Foundation 

1-15 Toranomon 

Minatoku-ku E-mail: s-hanayama@sof.or.jp 

Tokyo105-0001 Tel: +813 3502 1886 

Japan Fax: +813 3502 2033 

Mr. Jan Linders 

Expert in Environmental Risk assessment 

 of Pesticides and Biocides 

RIVM-SEC 

P.O Box 1 E-mail: jan.linders@rivm.nl 

NL- 3720 BA Bilthoven Tel: +31 30 274 3164 

Netherlands Fax: +31 30 274 4401 
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Mr. Celso Mauro 

Technical Consultant 

PETROBRAS -CENPES 

Av. Jequitib· 950 

Cidade Universit·ria 

Ilha do Fund„o, Rio de Janeiro E-mail: cmauro@petrobras.com.br 

RJ CEP: 21941-598 Tel: +55 21 38656659 

Brazil Fax: +55 21 38654975 

Mr. David Tongue 

Marine Manager 

International Chamber of Shipping E-mail: david.tongue@marisec.org 

12 Carthusian Street Tel: +44 2074718844 

London EC1M 6EZ Fax: +44 2074178877 

United Kingdom Mobile: +44 (0)7855391258 

IMO ñGESAMP CONSULTANTS 

Dr. Mel Cooke 

Director 

Alchemy Compliance Ltd. 

7 Western Fields 

Ruddington E-mail: info@alchemycompliance.com 

Nottinghamshire NG11 6JE Tel: +44 115 878 1489 

United Kingdom Fax: +44 115 8781489 

Dr. Manfred Nauke 

Technical Adviser to IMO 

Marine Environment Division 

16 Green Bank 

Woodside Avenue E-mail: manfrednauke@aol.com 

London N12 8AS Tel: +44 208 445 7958 

United Kingdom 

IMO SECRETARIAT

Mr. Dandu Pughiuc 

IMO Technical Secretary to GESAMP/BWWG 

International Maritime Organization 

Marine Environment Division 

4 Albert Embankment E-mail: dpughiuc@imo.org 

London SE1 7SR Tel: +44 (0)20 7587 3247 

United Kingdom Fax: +44 (0)20 7587 3261 
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Mr. RenÈ Coenen 

IMO Technical Secretary to GESAMP 

International Maritime Organization 

Marine Environment Division 

4 Albert Embankment E-mail: rcoenen@imo.org 

London SE1 7SR Tel: +44 (0)20 7587 3239 

United Kingdom Fax: +44 (0)20 7587 3261 

* * * 
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ANNEX 2 

AGENDA FOR THE FIRST SESSION OF THE 

BALLAST WATER WORKING GROUP OF GESAMP 

1 Introduction 

2 Issues of confidentiality 

3 Terms of Reference 

4 Development of a draft methodology for information gathering in accordance with the 

Procedure for Approval of BWM that makes use of Active Substances (G9) 

5 Review of proposals for approval of Active Substances submitted by Germany and the 

Republic of Korea 

6 Matters arising from IMO and other Organizations relevant to the activity of the 

GESAMP-BWWG 

7 Consideration of queries from members and industry related work of the 

GESAMP-BWWG 

8 Future work programme and tentative date for the next meeting 

9 Consideration and adoption of the report 

* * * 
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ANNEX 3 

TERMS OF REFERENCE FOR THE 

GESAMP-BALLAST WATER WORKING GROUP 

This document is an expanded version of the terms of reference for the Group and 

includes in full relevant reference to the G9 procedures. 

1 Prepare the draft of methodologies and information requirements in accordance 

with G9 for consideration by MEPC 54. 

2 For Basic Approval - review the comprehensive proposals submitted by 

Members of the Organization, along with additional data that have been 

submitted, as well as other information available to the Group and report to the 

Organization, in particular, the Group shall undertake the: 

.1 Scientific evaluation of the data set out in the proposal for approval (G9, 

paragraph 4.2, 6.1, 8.1.2.3, 8.1.2.4), i.e.: 

(a) data on effects on aquatic plants, invertebrates, fish and other biota, 

including sensitive and representative organisms: 

-acute aquatic toxicity 

-chronic aquatic toxicity 

-sediment toxicity 

-bioavailability/biomagnification/bioconcentration 

-food web/population effects 

(b) data on mammalian toxicity: 

-acute mammalian toxicity 

-effects on skin and eye 

-chronic and long-term toxicity 

-developmental and reproductive toxicity 

-carcinogenicity, mutagenicity 

(c) data on environmental fate and effect aerobic and anaerobic: 

- modes of degradation (biotic, abiotic) 

- bioacculumation, octanol/water partition co-efficient 

- persistence and identification of the main metabolites in 

 ballast water (marine and fresh water) 

(d) data on physical and chemical properties of Active Substances and 

preparations and the treated ballast water, if applicable: 

-melting points 

-boiling points 

-flammability 
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-density 

-water solubility, dissociation constant (pKa) 

-oxidation/reduction potential 

-corrosivity to the material and equipment of normal ship 

-autoignition temperature, and 

-other known relevant physical chemical hazards 

(e) review of analytical methods at environmentally relevant 

concentrations, 

taking into account that testing procedures must contain rigorous quality 

control/ quality assurance programme consisting of both: 

- a quality management plan (QMP), and 

- a quality assurance project plan (QAPP) 

.2 Scientific evaluation of the assessment report contained in the proposal for 

approval including the toxicity testing procedures with treated ballast 

water, i.e.: 

-acute aquatic toxicity: 

short term L(E) Cx from freshwater or saltwater representatives of algae, 

crustacean and fish 

-chronic toxicity: 

long-term NOECS or ECx, algae, crustacean and /or fish or other relevant 

species representing at least three trophic levels 

.3 Scientific evaluation of risks to ship and personnel including handling, 

storage and application: 

-hazard profiles, Material Safety Data Sheet 

-physical and chemical properties, 

-mammalian toxicity 

taking into account trade circumstances (ice, tropical areas, etc.) 

.4 Scientific evaluation of any further information that has been provided: 

Contributions submitted by Parties, IMO-Members, UN agencies, 

Non-Governmental Organizations and Governmental Organizations to the 

request for approval 

.5 Scientific review of the risk characterisation and analysis in the proposal 

for approval: 

-Evaluate potential impact in regard to: 
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! toxicity of Active Substances in treated ballast water and BW 

discharges 

! production of free radicals, production rates 

! route of abiotic and biotic degradation, identify degradation rates under 

specified conditions, e.g. pH, redox, temperature 

-determine solid-water partition co-efficient (Kd), and/or organic carbon 

 normalised distribution coefficient (KOC) 

-assess the potential for bioaccumulation in marine 

 or freshwater organisms if log POW is >3 

-predict discharge concentrations at selected time intervals 

- effects of Active Substances etc. on primary producers (algae) 

 consumers (crustaceans) and predators (fish) as well as secondary 

 poisoning 

 of mammalian and avian top-predators 

-in case of lack of bioconcentration potential (BCF <500 L/μg), an 

assessment of secondary poisoning is redundant 

- in case the potential for partition into the sediment is low 

 (e.g. KOC <500 L/ μg) an assessment of sediment species is redundant 

-effect assessment shall include the screening on carcinogenic, mutagenic 

 and endocrine disruptive properties 

-effect assessment should be based on internationally recognised 

 guidelines 

.6 Prepare scientific recommendations on whether the proposal demonstrated 

the potential for unreasonable risk to the environment, human health, 

property or resources 

.7 Prepare a report (Basic Approval) on the above for consideration by 

MEPC 

3 For the Final Approval - the Group should review the discharge testing data and 

confirm that the residual toxicity of the discharges conform to the evaluation 

undertaken for the Basic Approval taking into account also handling, storage and 

application requirements. 

4 The Group shall keep confidential all data, which might undermine the 

commercial interests of the applicant. 

* * * 
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ANNEX 4 

Draft Methodology for Information Gathering in Accordance 

with the ëProcedure for Approval of BWM Systems that Make 

Use of Active Substances G9í 

1 Terms and Definitions......................................................................................................23

2 General.............................................................................................................................24

2.1 Legal provision ........................................................................................................24

2.2 Principles of acceptability Active Substances or Preparations ................................24

2.3 Data submission .......................................................................................................24

2.4 Confidentiality and data protection..........................................................................25

2.5 Test Methods............................................................................................................25

2.6 Alternatives to testing and non-submission of data .................................................26

2.7 Procedures and timelines .........................................................................................26

3 Data-set required in the application .................................................................................26

 3.1. Identification of the substance or preparation (G9: 4.1) ..................................26

3.2 Data on effects on aquatic plants, invertebrates and fish, and other biota, including sensitive and 

representative organisms (G9: 4.2.1.1) ................................................................................27

3.2.1 Acute aquatic toxicity ......................................................................................27

3.2.2 Chronic aquatic toxicity...................................................................................27

3.2.3 Endocrine disruption........................................................................................28

3.2.4 Sediment toxicity .............................................................................................28

3.2.5 Bioavailability/biomagnification/bioconcentration..........................................28

3.2.6 Food web/population effects............................................................................28

3.3 Data on mammalian toxicity (G9: 4.2.1.2) ..............................................................29

3.3.1 Acute toxicity...................................................................................................29

3.3.2 Effects on skin and eye ....................................................................................29

3.3.3 Repeated-dose toxicity.....................................................................................30

3.3.4 Chronic toxicity ...............................................................................................30

3.3.5 Developmental and reproductive toxicity ........................................................30

3.3.6 Carcinogenicity ................................................................................................30

3.3.7 Mutagenicity/genotoxicity ...............................................................................30

3.3.8 Toxicokinetics..................................................................................................31
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3.4 Data on environmental fate and effect under aerobic and anaerobic conditions (G9: 4.2.1.3)

 31

3.4.1 Modes of degradation (biotic; abiotic).............................................................31

3.4.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient.....32

3.4.3 Persistence and identification of the main metabolites in the relevant media (ballast water, 

marine and fresh waters)..................................................................................................32

3.4.4 Reaction with organic matter ...........................................................................33

3.4.5 Potential physical effects on wildlife and benthic habitats ..............................33

3.4.6 Potential residues in seafood............................................................................33

3.4.7 Any known interactive effects .........................................................................33

3.5 Physical and chemical properties for the active substances and preparations and treated ballast 

water, if applicable (G9: 4.2.1.5) .........................................................................................33

3.5.1 Melting point....................................................................................................33

3.5.2 Boiling point ....................................................................................................34

3.5.3 Flammability (flash point) ...............................................................................34

3.5.4 Density (relative density).................................................................................34

3.5.5 Vapour pressure, vapour density......................................................................34

3.5.6 Water solubility/dissociation constant .............................................................34

3.5.7 Oxidation/reduction potential ..........................................................................34

3.5.8 Corrosivity to the materials or equipment of normal ship construction...........34

3.5.9 Autoignition temperature .................................................................................34

3.5.10 Explosive properties.........................................................................................34

3.5.11 Oxidising properties.........................................................................................34

3.5.12 Surface tension.................................................................................................35

3.5.13 Viscosity ..........................................................................................................35

3.5.14 Thermal stability and identity of relevant breakdown products.......................35

3.5.15 Reactivity towards container material..............................................................35

3.5.16 pH.....................................................................................................................35

3.5.17 Salinity .............................................................................................................35

3.5.18 TOC, DOC, % particulate matter.....................................................................35

3.5.19 Other known relevant physical or chemical hazards........................................35

3.6 Analytical methods at environmentally relevant concentrations (G9: 4.2.1.5)........35

3.6.1 Analytical methods at environmentally relevant concentrations .....................35

4 Use of the Preparation......................................................................................................35

4.1 The manner of application .......................................................................................35
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5 Material Safety Data Sheets.............................................................................................36

6 Risk Characterisation .......................................................................................................36

6.1 Screening for persistence, bioaccumulation and toxicity (G9: 5.1) .........................36

6.1.1 Persistence (G9: 5.1.1.1)..................................................................................36

6.1.2 Bioaccumulation (G9: 5.1.1.2).........................................................................37

6.1.3 Toxicity tests (G9: 5.1.2.3) ..............................................................................37

6.1.4 Does the active substance and or preparation meet all three criteria for PBT?37

6.2 Evaluation of the treated ballast water (G9: 5.2) .....................................................37

6.2.1 Basic approval..................................................................................................37

6.2.2 Final approval ..................................................................................................37

6.2.3 Determination of holding time.........................................................................38

6.3 Risk characterisation and analysis ...........................................................................38

6.3.1 Reaction with organic matter (see G9: 4.2.1.3; this report 2.4.4) ....................38

6.3.2 Characterisation of persistence (G9: 5.3.5)......................................................38

6.3.3 Prediction of discharge concentrations ............................................................38

6.3.4 Assessment of potential for bioaccumulation ..................................................38

6.3.5 Effects assessment............................................................................................38

6.3.6 Comparison of effect assessment with discharge toxicity ...............................40

7 Assessment report (G9: 4.3) ............................................................................................41

7.1 Quality of the test reports (G9: 4.3.1) ......................................................................41

7.2 Risk characterisation................................................................................................41

7.3 Consideration of the uncertainty associated with the assessment............................41

8 Modification to the application........................................................................................42

9 Final approval ..................................................................................................................42
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This document gives the responsibility of the applicant in providing data to the Organisation, and 

the procedures used by the Organization for evaluating applications, according to Resolution 

MEPC.126(53) on a Procedure for the approval of Ballast Water Management Systems That 

Make Use of Active Substances (G9). 

1 Terms and Definitions 

For the purpose of this paper: 

.1 Ballast Water Convention means the International Convention for the Control 

and Management of Shipsí Ballast Water and Sediments, 2004. 

.2 Ballast Water Management means mechanical, physical, chemical and 

biological processes - either singularly or in combination - to remove, render 

harmless, or avoid the uptake or discharge of Harmful Aquatic Organisms and 

Pathogens within Ballast Water and Sediments. 

.3 General obligation of the Convention means, ìParties undertake to give full and 

complete effect to the provisions of this Convention and the Annex thereto in 

order to prevent, minimize and ultimately eliminate the transfer of Harmful 

Aquatic Organisms and Pathogens through the control and management of shipsí 

Ballast Water and Sediments.î (Article 2, para. 1) 

.4 Active Substances means Active Substances or Preparations containing one or 

more Active Substances used to comply with the Convention. 

.5 Basic Approval means the approval of a comprehensive proposal regarding the 

use of Active Substances submitted by a Member, normally through its Maritime 

Administration, to the Organization. 

.6 GESAMP Ballast Water Working Group means the Technical Group that 

reports through GESAMP to MEPC. When considering the comprehensive 

proposal, the Group shall take account of any other relevant data as well as other 

relevant information submitted to it. 

GESAMP is the IMO/FAO/UNESCO-IOC/WMO/WHO/IAEA/UN/UNEP Joint 

Group of Experts on the Scientific Aspects of Marine Environmental Protection, 

an advisory and multi-disciplinary body consisting of specialised experts 

nominated by the sponsoring agencies. Experts working for GESAMP act 

independently in their individual capacity. 

.7 Final Approval means a review of the Basic Approval, supplemented with 

additional data regarding operational practices on board ships and discharge 

testing data from the field, i.e. in ports and harbours, estuaries, coastal zones, etc.. 

The Final Approval shall also confirm that previous evaluations of risks to ship 

and crew including storage, handling and application of active substances remain 

valid. 

.8 Experimental application period ñ In maximum, five years (according to G10), 

after the issue of Basic Approval, the Member of the Organization concerned shall 

submit a report to the Organization summarizing the results gained with the 

experimental application of the Active Substance, as well as any consequences 
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that had to be taken into account in improving the system. This report will include 

all non-confidential and public information. 

A comprehensive report comprising all data resulting from the experimental application, 

including the confidential information will be submitted to the Organization for evaluation by the 

GESAMP-BWWG following the procedure for Basic Approval. The Group shall report through 

GESAMP to MEPC confirming that the residual toxicity conforms to the evaluation undertaken 

for Basic Approval 

2 General 

2.1 Legal provision 

Regulation D-3.2 of the International Convention for the Control and Management of Shipsí 

Ballast Water and Sediments, 2004, stipulates that Ballast Water Management Systems (BWMS) 

that make use of Active Substances to comply with the Convention shall be approved by the 

Organization. During its fifty-third session, the Marine Environment Protection Committee 

(MEPC) adopted the Procedure for approval of Ballast Water Management Systems that make 

use of Active Substances (G9) through resolution MEPC.126(53). 

2.2 Principles of acceptability regarding Active Substances or Preparations 

Active Substances or Preparations accomplish their intended purpose through action on Harmful 

Aquatic Organisms and Pathogens in shipsí 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 (G9: 3.2). 

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 

(G9: 3.3). 

2.3 Data submission 

Procedure to be followed: The manufacturer should evaluate the Active Substances or 

Preparations and the potential discharge in accordance with the approval criteria specified below 

(G9: 8.1.2.1). Upon completion, the manufacturer should prepare an Application on the Active 

Substances and Preparations and submit it to the Maritime Administration of a Member of the 

Organization concerned (G9: 8.1.2.2). 

Applications for basic approval of Active Substances to be evaluated by the GESAMP Ballast 

Water Working Group should be addressed to: The Director, Marine Environment Division, 

International Maritime Organization, 4 Albert Embankment, London SE1 7SR, United Kingdom 

Application requirements: 

• Complete application including all documents below (one paper version), including full 

study reports and full copies of literature. The complete application should contain a 

contents list indicating the location of the information in the application. The order in 

which the information is presented, including overall structure such as how information is 

presented for the active substance, preparation, ballast water, risk assessment, assessment 

report, should follow this format, including its numbering, which is based on G9 
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• Non-confidential summary document (as provided to MEPC) to provide an overview of 

the application (electronic version) 

• A summary of the key data should be provided in a tabular format (electronic version) 

• The assessment report (electronic version) 

Dossiers already used for registration of chemicals can be used to satisfy the data requirements of 

the G9 procedure (G9: 4.2.5). 

2.4 Confidentiality and data protection 

The confidential information of the submitted documents should clearly be identified. 

Once an approval procedure is completed and the active substance is approved, the following 

data shall not be regarded as confidential: 

• The name and address of the applicant 

• The names and addresses of the manufacturers of the Active Substance and/or the 

preparation (if different) 

• The names and content of the Active Substance(s) in the preparations and the name of the 

preparation 

• The names of other substances which are regarded as dangerous according to the UN 

GHS or relevant IMO regulations and contribute to the hazard documentation of the 

preparation 

• Physical and chemical data concerning the Active Substance and preparation 

• A summary of the results of the tests required pursuant to Section 4.2 of the Procedure to 

establish the effects of the substance(s) or preparation(s) on humans and the environment 

• Recommended methods and precautions against dangers resulting from handling, storage, 

transport and fire 

• Any means of rendering the active substance or preparation harmless 

• Safety data sheets 

• Methods of chemical analysis 

• Methods of disposal of the product and of its packaging 

• Procedures to be followed and measures to be taken in the case of spillage or leakage 

• First aid and medical advice to be given in the case of injury to persons. 

2.5 Test Methods 

Tests should be carried out by internationally recognized guidelines (preferably OECD or 

equivalent) (G9: 4.2.3), and according to an internationally recognised quality assurance system 

(G9: 4.2.4) (eg GLP). 

Information may be derived from existing data where an acceptable justification is provided. Full 

copies of sources of data (eg literature papers) should be provided. 

Care should be taken to provide full supporting references and copies of the appropriate test 

laboratory reports in support of each application. Submissions that are lacking relevant 

information may not be accepted for risk assessment. Many substances have acquired large 

databases for many of the hazards concerned and a weight of evidence approach has become 

necessary to ensure that the rating reflects the body of data rather than simply using the most 

conservative value. This, however, requires the submission of all available end-point data for 

Active Substances and relevant chemicals. 
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The applicant should supply a list of test substances (for example trade names) specified in study 

reports and literature data and an explanation of how the tested substances relates to the current 

application. 

2.6 Alternatives to testing and non-submission of data 

Methods alternative to testing on organisms, e.g. in vitro testing methods, QSAR, extrapolation 

by analogy to known chemicals, or grouping of similar substances, may be used whenever 

justified. Sufficient documentation or references to documentation, on the validity of the method 

should be provided, as well as documentation that the substance or preparation lies within the 

domain of the method. 

Information which is not necessary owing to the nature of the substance or of its proposed uses 

and taking into account all proposed risk management measures need not be supplied. The same 

applies where it is not scientifically necessary or technically possible to supply the information. 

In such cases a justification must be submitted. 

2.7 Procedures and timelines 

The procedures for evaluation of the dossier are given in the Appendix to G9. 

If in the course of the review by the Ballast Water Working Group it becomes evident that 

additional data is found to be necessary to finalize the evaluation, the Group may request that 

such data is submitted. 

The applicant will be informed in writing of the decision of the Organization. The applicant may 

appeal against any decision made by the Organization. The Organization will consider the appeal 

and respond in writing to the Member of the Organization. 

It may be useful for a technical representative of the company to be available to the BWWG for 

an hour or so to answer questions regarding the system. 

3 Data-set required in the application 

The dossier should contain the information specified in G9. Non-submission of information 

should be justified. 

For active substances and/or preparations as appropriate, data on properties should be included. 

For other components in preparations that may contribute to the hazards, data should be provided 

as well. 

Fate and effect testing should be performed in the laboratory with active substances and 

preparations (G9: 5.3.1). However, the Group notes that assessment of fate (including 

degradation, bioaccumulation) is not feasible for preparations, but only for individual substances. 

Therefore degradation and fate testing of preparations is not appropriate. 

For treated ballast water, the applicant should provide both acute and chronic toxicity data (G9: 

5.2.2). The discharge toxicity tests should include chronic test methods with test species (fish, 

invertebrate, algae) that address the sensitive life stage (G9: 5.2.4). The results should include 

acute LC50 values and NOECs, and chronic NOECs or EC50s (G9: 5.2.5). Therefore 100% ballast 

water discharge should be tested (G9: 5.2.6), if appropriate. 

3.1 Identification of the substance or preparation (G9: 4.1) 

Preparation 

The application should include a list of the name and relative quantities of the components (G9: 

4.2.2) 

• Trade name 

• composition (liquids in g/l; solids in %w/w; gases in %v/v), including CAS numbers and 

chemical names 

• UN number and name 
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Active substance 

• Trade name, chemical (IUPAC) name, CAS number, UN number and name 

• Molar mass, empirical formula, structural formula 

• Purity of the technical material and identification of impurities (chemical name and CASnumbers) 

• Identity of any stabilisers or necessary additives 

Relevant chemicals (G9: 2.1.4) 

• Chemical (IUPAC) name, CAS number 

• Molar mass, empirical formula, structural formula 

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

sensitive and representative organisms (G9: 4.2.1.1) 

For every Active Substance or preparation data should be presented and discussed either on the 

basis of toxicological tests or existing toxicological knowledge for each end point listed. 

3.2.1 Acute aquatic toxicity 

Short-term L(E)Cx from freshwater or saltwater1 representatives of three taxonomic groups 

(algae, crustaceans and fish) representing three trophic levels (OECD guidelines 201 (Algae, 

Growth Inhibition Test), 202 (Daphnia sp. Acute Immobilization Test) and 203 (Fish, Acute 

Toxicity Test)), Mysid shrimp acute toxicity test (USEPA 850.1035), and an activated sludge 

respiration inhibition test (OECD guidelines 209, and other well established guidelines) shall be 

accepted. To reduce further any remaining uncertainty, applicants should preferably also submit 

data for two additional marine taxonomic groups (e.g. echinoderms, molluscs). 

Preparation 

Active substance 

Information on other components 

Relevant chemicals 

Treated ballast water (G9: 5.2.3) 

3.2.2 Chronic aquatic toxicity 

Long-term NOECs or ECx from three freshwater or saltwater species (normally algae and/or 

crustaceans and/or fish) representing three trophic levels (e.g. Fish: OECD 210, 215, or 212; 

Daphnia: OECD 211). To reduce further any remaining uncertainty, applicants should preferably 

also submit two long-term NOECs from additional marine taxonomic groups (e.g. echinoderms, 

molluscs). 

In case of whole effluent testing, EPA short term methods for estimating the chronic toxicity of 

substances and discharge provide acceptable alternatives, since the identification of the sensitive 

sub-lethal endpoints and vulnerable life-stages is the ultimate aim of the long-term testing. 

Preparation 

Active substance 

Information on other components 

Relevant chemicals 

 

1 The species tested should be relevant to the environments likely to be affected due to the manner of use or 

disposal of the substance. Seawater species should be used if the substance is likely to influence directly or 

indirectly only estuarine or marine environments. If a marine or brackish water environment is affected but it is 

not the only aquatic target environment, then a toxicity test in a marine or in a brackish water species, 

respectively is required in addition to the fresh water tests. 
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Treated ballast water (fish, invertebrate, plant) (G9: 5.2.3) 

3.2.3 Endocrine disruption 

Regarding the risks connected to endocrine disruption, non-standardized in vivo as well as in vitro 

tests will be accepted as long as no internationally standardized tests are available (e.g. full-life-cycle 

test on fish or amphibian metamorphosis assay). When substantial evidence on such effects is 

available, this should be taken into account on a case-by-case basis in the PBT assessment (as a 

substitute for the T end point) and in the effect assessment for each compartment of relevance. If 

there is no indication for endocrine disruption ñ e.g. due to the structure of the substance or results of 

other available studies ñ these tests may be waived. 

Preparation 

Active substance 

Information on other components 

Relevant chemicals 

3.2.4 Sediment toxicity 

Substances that are potentially capable of depositing on or adsorbing to sediments to a significant 

extent have to be assessed for toxicity to sediment-dwelling organisms. Testing is required only if log 

Kow > 5 or if there is similar adsorption behaviour and should include a maximum of three long-term 

tests with species representing different living and feeding conditions (e.g. Chironomus spec. (OECD 

218), Lumbriculus variegates) including a minimum of two tests with marine species. 

For substances that are persistent in marine waters or may accumulate in sediments, a specific marine 

sediment assessment is necessary. 

Preparation 

Active substance 

Information on other components 

Relevant chemicals 

Ballast water 

3.2.5 Bioavailability/biomagnification/bioconcentration 

If log Pow > 3, testing should include: 

• One bioconcentration factor (BCF) determined in a bioconcentration study (at two dosing 

levels) with fish (e.g. OECD 305) or bivalves. The BCF should be based on 

uptake/elimination kinetics (k1/k2). The half-life for elimination should be reported. Fat 

content in marine fish typically ranges between 0.5 and 15% of the whole body weight. BCF 

should be normalized to 6% fat. 

• The biomagnification and persistence in the food web should be discussed based on the 

results from aquatic toxicity testing, mammalian toxicity evaluation and bioaccumulation and 

biodegradation data. 

• There are no data requirements on bio-availability since it is considered that the bioavailability in the toxicity test systems is equivalent to the conditions under assessment. If the 

bioavailability of the Active Substance or relevant chemical in the discharge or the receiving 

environment is to be assessed, consequently the bio-availability in the toxicity testing is to be 

reconsidered. 

Active substance 

Information on other components 

Relevant chemicals 

3.2.6 Food web/population effects 

The biomagnification and persistence in the food web should be discussed based on the results from 

aquatic toxicity testing, mammalian toxicity evaluation and bioaccumulation and biodegradation 
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data. An assessment of secondary poisoning is redundant if for the substance of concern absence 

of bioaccumulation potential can be demonstrated (BCF <500 L/kg wet weight for the whole 

organism at 6% fat). If not, testing should include: 

• One long-term NOECs based on reproduction studies with a bird species 

• Two NOECs from long-term studies with two mammalian species (from Section 2.3 

below). 

Active substance 

Information on other components 

Relevant chemicals 

3.3 Data on mammalian toxicity (G9: 4.2.1.2) 

Information which is not necessary need not be supplied (e.g. for a reduction of experiments 

involving vertebrate animals, screening tests negative, appropriate risk management measures are 

in place - see also point 2 above). In such cases a justification must be submitted. Lack of data 

with missing justification will in general not allow any approval. 

If available, human experience or epidemiological evidence should be presented and discussed. 

3.3.1 Acute toxicity 

The acute toxicity should be known for at least two routes of exposure, one of which should be 

the oral route. Active Substances or Preparations that are gases or produce vapours during the use 

should be tested by inhalation. The submission of dermal and/or inhalation studies instead of or 

in addition to oral studies may be required depending on the physico-chemical properties of the 

substance, the proposed or potential application of the substance/products. These tests should be 

performed with the Active Substances or Preparation. 

Preparation 

Active substance 

Information on other components 

Relevant chemicals

3.3.2 Effects on skin and eye 

The tests shall provide information on the degree and nature of skin, eye and associated mucous 

membrane irritation, especially with regard to the reversibility of responses. The tests shall 

provide sufficient information to assess the potential to cause skin sensitization reactions. Animal 

testing should, whenever possible, be minimized. Tests should be performed with the Active 

Substance(s). 

Testing of Active Substances or Preparation should include a study on acute dermal 

irritation/corrosion and a study on acute eye irritation/corrosion. The recommended tests are 

OECD guidelines 404 (Acute Dermal Irritation/Corrosion) and 405 (Acute Eye 

Irritation/Corrosion). These tests need not be carried out on a strong acid or base (pH below 2 or 

above 11.5). Where the Active Substance or Preparation has shown to have potentially corrosive 

properties, or is a severe skin irritant, eye irritation test shall not be carried out. It should be 

possible to accept results from in vitro test methods, which are close to validation by recognized 

organizations. 

The recommended test for Skin Sensitization is OECD guideline 406. While the guinea-pig 

Maximization test is considered to be the preferred adjuvant technique in certain cases there may 

be good reasons for choosing the Buehler test or the Local Lymph Node Assay (LLNA). 

However, scientific justification may be given when either of the two latter mentioned is used. 

The test is not needed if the Active Substance or Preparation is already classified in an 

internationally recognized system or otherwise known as a sensitizer. 

Preparation 
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Active substance 

Information on other components 

Relevant chemicals

3.3.3 Repeated-dose toxicity 

A 90-day sub-chronic toxicity study in two species, one rodent and another mammalian species, 

using the oral route unless another one is more appropriate. 

Preparation 

Active substance 

Information on other components 

Relevant chemicals 

3.3.4 Chronic toxicity 

A chronic toxicity study of a minimum duration of 12 months in two species, one rodent and 

another mammalian species unless a full justification demonstrates that this test is not necessary. 

Any chronic study can be combined with a carcinogenicity study. 

Preparation 

Active substance 

Information on other components 

Relevant chemicals 

3.3.5 Developmental and reproductive toxicity 

Testing should include: 

• A two-generation reproduction and fertility study (OECD guideline 416 ñ 

Two-Generation Reproduction Toxicity Study) 

• A prenatal developmental toxicity (teratogenicity) study in two species (OECD 

guideline 414 - Prenatal Developmental Toxicity Study). 

However, these key data requirements can be modified (either reduced or accelerated or 

extended) and influenced by factors such as structural relationships with a known reproductive 

toxicant, the results of other toxicity studies (incl. toxicokinetics), concerns for endocrine 

disruption and anticipated use and human exposure patterns. 

Preparation 

Active substance 

Information on other components 

Relevant chemicals

3.3.6 Carcinogenicity 

Carcinogenicity studies for should be performed with one rodent and one other mammalian 

species. The carcinogenicity testing of an Active Substance or preparation may not be required 

where justification demonstrates that these tests are not necessary. Carcinogenicity studies may 

be combined with the chronic toxicity studies. 

Preparation 

Active substance 

Information on other components 

Relevant chemicals 

3.3.7 Mutagenicity/genotoxicity 

Genotoxicity data should be available for Active Substances or preparations from at least three 

tests: a bacterial gene mutation test, an in vitro mammalian cell cytogenicity study and an in vitro 

mammalian cell gene mutation assay. In case of positive or equivocal results, further in vivo 
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mutagenicity testing with bone marrow assay for chromosomal damage or a micronucleus test is 

necessary. If this test is negative it should be evaluated whether mutagenicity or evidence of 

DNA damage can be demonstrated in tissue other than bone marrow. 

Preparation 

Active substance 

Information on other components 

Relevant chemicals 

3.3.8 Toxicokinetics 

Basic data on toxicokinetics of Active Substances or Relevant Chemicals on adsorption, 

distribution, metabolism and elimination (e.g. OECD 417) should be presented, if available, to 

allow better understanding of toxic effects and a reduction of animal testing. The potential for 

dermal absorption should be evaluated preferably in vitro or by phys-chem data to reduce the 

need for any specific dermal toxicity testing. 

3.4 Data on environmental fate and effect under aerobic and anaerobic conditions 

(G9: 4.2.1.3) 

The route of abiotic and biotic degradation of the Active Substances and other components 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) (G9: 5.3.4). 

The partition coefficients [solids-water partition coefficient (Kd) and/or organic carbon 

normalized distribution coefficient (Koc)] of the Active Substances, other components and 

Relevant Chemicals should be determined (G9: 5.3.6). 

The data submitted in accordance with this paragraph should clarify, in addition to the 

degradation of the substance, other relevant routes of dispersion in and from water, such as 

volatilization, adsorption, sedimentation and transformation into bound residues. Accordingly the 

exposure of organisms living in water and the sediment should be established. 

3.4.1 Modes of degradation (biotic; abiotic) 

Testing should include: 

• A study on hydrolysis at pH 5, 7, and 9 under aerobic conditions according to OECD 

guideline 111 

• A study on ready biodegradability according to OECD guideline 301 (Ready 

Biodegradability) or equivalent guidelines if the Active Substance is discharged only into 

fresh water 

• A study on ready biodegradability according to OECD guideline 306 (Biodegradability in 

Seawater) or equivalent guidelines if the Active Substance is discharged only into marine 

water 

• Studies on ready biodegradability according to OECD guideline 301 (or equivalent 

guidelines) and OECD guideline 306 (or equivalent guidelines) if the Active Substance is 

discharged into estuarine water (e.g. inland harbour with contact to seawater). 

If the Active Substance is not readily biodegradable, then the following higher tier studies are 

necessary: 

• A study on aerobic and anaerobic transformation in aquatic sediment systems according 

to OECD guideline 308 (Aerobic and Anaerobic Transformation in Aquatic Sediment 

Systems) or equivalent guidelines if Koc >500 L/kg, using fresh or marine water 
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depending on kind of aquatic ecosystem where discharge is intended. At least one system 

with high organic matter/nutrient content and one with low organic matter/nutrient 

content should be tested (see above) 

• A study on aerobic transformation of low concentrations of organic contaminants 

according to OECD guideline 309 (Aerobic Mineralization in Surface Water - Simulation 

Biodegradation Test) or equivalent guidelines, using fresh or marine water depending on 

the kind of aquatic ecosystem where discharge is intended 

• Where relevant, a study on photo-transformation in water [e.g. US EPA OPPTS 835.2210 

(1998) and/or OECD Guidance document on phototransformation in water (1997)] 

Active substance 

Information on other components 

Relevant chemicals 

3.4.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient 

Testing should include: 

• Data on bioconcentration and biomagnification, which have already been detailed earlier 

in this document 

A study into the log Pow according to OECD guideline 107 [Partition Coefficient 

(n-octanol/water): Shake Flask Method] or equivalent test guidelines. For very hydrophobic 

compounds a slow stirring method is required: 

• The partition coefficient between solids and liquids should be determined [e.g. according 

to EU Technical Guidance Document on Risk Assessment (2003) for at least three 

inocula, including freshwater sediment, marine sediment, and particulate matter (sludge)]. 

If no measured data are available for a specific adsorbing material, it is assumed that all 

adsorption can be related to the organic matter of the medium, viz. standardization to Koc. This is 

only valid for non-ionic substances. For ionic substances the Kp values and the test characteristics 

(%clay, CEC, %o.c., pH) should be reported. 

Active substance 

Partition coefficient n-octanol/water including effect of pH (5 to 9) and temperature 

Information on other components 

Relevant chemicals 

3.4.3 Persistence and identification of the main metabolites in the relevant media (ballast 

water, marine and fresh waters) 

The route of degradation in the tests required under section 3.4.1 of this document is to be 

characterized, based on a mass balance including mineralization and formation of bound residue. 

Metabolites formed in relative amounts of >5% of the initial dose at any point in time are to be 

identified. For relevant chemicals the application shall contain all data as specified before, since 

they are subject to the decision making criteria. 

Active substance 

Information on other components 

Relevant chemicals 
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3.4.4 Reaction with organic matter 

The reaction of active substances that are radical producing agents, with organic matter shall be 

addressed qualitatively as to identify products of concern to the environment. Radical producing 

chemicals are capable of forming halogenated (chlorinated, brominated) hydrocarbons which 

may be of concern to environmental or human health, in the presence of organic matter. For these 

substances, the freely and otherwise reasonably available information should be presented and 

discussed in relation to the proposed manner of application, since they are subject to the decision 

making criteria. 

Active substance 

Information on other components 

Relevant chemicals

3.4.5 Potential physical effects on wildlife and benthic habitats 

Data requirements consist of physical-chemical properties also required later. Further guidance 

can be found in the MEPC approved hazard evaluation procedure published as GESAMP Reports 

and Studies No. 64. 

Preparation 

Active substance 

Information on other components 

Relevant chemicals 

Ballast water 

3.4.6 Potential residues in seafood 

As appropriate, data shall be submitted to assess the risk that residues of the active substance end 

up in seafood, the possible impact on consumer safety and the level of residues that may be 

tolerated in seafood. Any available monitoring data on residues of the substance in seafood shall 

be submitted. 

Preparation 

Active substance 

Information on other components 

Relevant chemicals 

3.4.7 Any known interactive effects 

Any knowledge (or absence of this knowledge) on interactive effects of the Relevant Chemicals 

with the ballast water, with other preparations to be used in ballast water, with other physical or 

chemical management of the ballast water, or with the receiving environment, should be 

reported. 

Active substance 

Information on other components 

Relevant chemicals

3.5 Physical and chemical properties for the active substances and preparations and 

treated ballast water, if applicable (G9: 4.2.1.5)

Data are necessary for the Active Substances, their preparations, the treated ballast water on 

board and the Relevant Chemicals discharged to allow for the identification of hazards for the 

crew, the ship and the environment. 

3.5.1 Melting point 

Preparation 

Active substance 

Information on other components 
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3.5.2 Boiling point 

Preparation 

Active substance 

Information on other components 

3.5.3 Flammability (flash point) 

Preparation 

Active substance 

Information on other components 

3.5.4 Density (relative density) 

Preparation 

Active substance 

Ballast water

3.5.5 Vapour pressure, vapour density 

Preparation 

Active substance 

Information on other components 

3.5.6 Water solubility/dissociation constant 

Active substance 

Water solubility and effect of pH (5 to 9) and temperature on solubility where relevant 

Dissociation constant (pKa) 

Information on other components 

Relevant chemicals 

Water solubility and dissociation constant 

3.5.7 Oxidation/reduction potential 

Preparation 

Active substance 

Ballast water 

also ëredoxí for ballast water used in type approval testing 

3.5.8 Corrosivity to the materials or equipment of normal ship construction 

Preparation 

Active substance 

Information on other components 

Relevant chemicals 

Ballast water 

3.5.9 Autoignition temperature 

Preparation 

Active substance

3.5.10 Explosive properties 

Active substance 

3.5.11 Oxidising properties 

Preparation 

Active substance 
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3.5.12 Surface tension 

Preparation 

Active substance 

3.5.13 Viscosity 

Preparation 

Active substance 

3.5.14 Thermal stability and identity of relevant breakdown products 

Active substance 

3.5.15 Reactivity towards container material 

Preparation 

Active substance 

3.5.16 pH 

Preparation 

Ballast water used in type approval testing 

3.5.17 Salinity 

Ballast water used in type approval testing 

3.5.18 TOC, DOC, % particulate matter 

Ballast water used in type approval testing 

3.5.19 Other known relevant physical or chemical hazards 

Preparation 

Active substance 

Information on other components 

Relevant chemicals 

Ballast water 

3.6 Analytical methods at environmentally relevant concentrations (G9: 4.2.1.5) 

3.6.1 Analytical methods at environmentally relevant concentrations 

Preparation 

Active substance 

Analytical methods for the detection of Active Substances in discharge water and sediment, at 

environmentally relevant concentrations, are required. The methods including sampling should 

be proven to be workable. 

Relevant chemicals 

Analytical methods for the detection of Relevant Chemicals in discharge water and sediment, at 

environmentally relevant concentrations, are required. The methods including sampling should 

be proven to be workable. 

4 Use of the Preparation 

4.1 The manner of application 

The proposal should include the manner of application of the preparation for the Ballast Water 

Management (BWM), including required dosage and retention time (G9: 4.2.6). 

In relation to point 7 of the Procedure, the dossier should contain the necessary data addressing 

the following items: 
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• The technical manual or instructions by the manufacturer, including the product 

specification, process description, operational instructions, details of the major 

components and materials used, technical installation specifications, system limitations, 

and routine maintenance should be provided (BWWG), including quantity to be added to 

ballast water and maximum concentration of the active substance therein. 

• Recommended methods and precautions concerning handling, use, storage, and transport 

• Procedures to be followed in case of fire, and nature of reaction products, combustion 

gases etc. 

• Emergency measures in case of an accident 

• Possibility of destruction or decontamination following release in the marine environment 

• Procedures of waste management of the active substance 

• Possibility of reuse or recycling 

• Possibility of neutralization 

• Conditions for controlled discharge 

• Amount of substance on board ship 

Risk management (e.g. for neutralization of the Active Substance in case of emergency or if 

PEC/PNEC at discharge >1) should be described. These management measures are an integral 

part of the Ballast Water Management System and should be evaluated in the assessment of the 

ballast water discharge. 

The risk management measures proposed should be evaluated in respect to the hazards to ship, 

personnel and the environment. 

5 Material Safety Data Sheets (G9: 4.2.7)

With respect to classification of hazards, a detailed technical guidance document has been 

prepared for the United Nationsí Globally Harmonized System of Classification and Labelling of 

Chemicals (GHS) to aid in interpreting data for classifying substances as dangerous. Reference is 

also made to the MEPC approved hazard evaluation procedure published as GESAMP Reports 

and Studies No. 64 under the title ëThe Revised GESAMP Hazard Evaluation Procedure for 

Chemical Substances Carried by Shipsí, which reflects the GHS for marine environmental 

protection aspects. The applicant is referred to this document for a more detailed guidance on 

hazard identification. 

For the preparation, each active substance, each hazardous component, and each Relevant 

Chemical, the classification under the GHS, and a Material Safety Data Sheet (G9: 6.3.2) should 

be provided by the applicant. Key data for these should be summarised in the Key Data Summary 

Table. 

6 Risk Characterisation 

6.1 Screening for persistence, bioaccumulation and toxicity (G9: 5.1) 

6.1.1 Persistence (G9: 5.1.1.1)

Persistence is preferably assessed in simulation test systems to 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. 
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For persistence and degradation data requirements, see 2.4.1 and 2.4.3 of this document. 

6.1.2 Bioaccumulation (G9: 5.1.1.2) 

The assessment of bioaccumulation potential should use measured bioconcentration factors in 

marine (or freshwater organisms). Where tests are not applicable, or log Pow <3, the 

bioconcentration factor may be estimated using structure activity relationships (SAR). 

For bioaccumulation data requirements, see 2.2.5 and 2.4.2 of this document. 

6.1.3 Toxicity tests (G9: 5.1.2.3) 

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

for the assessment of the toxicity criterion. 

For ecotoxicity data requirements, see 2.2 of this document. 

It is necessary to consider, whether an effect assessment based on tests in freshwater species 

offers sufficient certainty that sensitive marine species will be covered by any risk assessment. 

6.1.4 Does the active substance and/or preparation meet all three criteria for PBT? 

See G9: Table 1 

Table 1 Criteria for identification of PBT substances

Criterion PBT criteria 

Persistence Half-life: 

> 60 days in marine water, or 

> 40 days in freshwater,a or 

> 180 days in marine sediment, or 

> 120 days in freshwater sedimenta

Bioaccumulation If Log Poctanol/water ≥3, then experimental 

BCF required. 

BCF > 2,000 

Toxicity Chronic NOEC < 0.01 mg/l a

 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. 

Active Substances or Preparations identified as PBT substances according to paragraph 6.4.1 of 

the Procedure shall not be approved. 

6.2 Evaluation of the treated ballast water (G9: 5.2) 

The advantage of toxicity testing on the ballast water discharge is that it integrates and addresses 

the potential by-products of the formulation and interactions with the system. 

6.2.1 Basic approval 

Testing should be performed in laboratory (G9: 5.2.1) 

6.2.2 Final approval 

Discharge test with whole system (G9: 5.2.2). 

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. The results should be conveyed to the 
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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 (G9: 8.2.1). 

6.2.3 Determination of holding time 

The test data should be used to determine the no adverse-effect concentration upon discharge. 

The half-life, decay and dosage rates, system parameters and toxicity should be used to determine 

the amount of time needed to hold the treated ballast water before discharge (5.2.7). An 

indication of the uncertainty of the holding time should be given, taking into account variables 

(e.g. temperature, pH, salinity and sediment loading). 

6.3 Risk characterisation and analysis 

6.3.1 Reaction with organic matter (see G9: 4.2.1.3; this report 2.4.4) 

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. 

6.3.2 Characterisation of persistence (G9: 5.3.5)

The route of abiotic and biotic degradation of the Active Substances and Preparations under 

aerobic and anaerobic conditions (see 2.4.1 above) 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). 

6.3.3 Prediction of discharge concentrations 

Based on the information on fate and behaviour of Active Substances and Preparations, the 

discharge concentrations at selected time intervals should be predicted (G9: 5.3.8). 

6.3.4 Assessment of potential for bioaccumulation 

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 (log Pow) is >3 (G9: 5.3.7). 

6.3.5 Effects assessment 

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 

(G9: 5.3.9). 

In the effect assessment only toxicity studies reporting on dietary and oral exposure are relevant, 

as the pathway for secondary poisoning refers exclusively to the uptake of chemicals through the 

food chain. It is necessary to extrapolate threshold levels for marine species from terrestrial 

species assuming there are interspecies correlations between laboratory bird species and marine 

predatory bird species and between laboratory mammals (e.g. rats) and the considerably larger 

marine predatory mammals. 

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) (G9: 5.3.10). 
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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) (G9: 5.3.11). 

The effect assessment of the Active Substances, Preparations and Relevant Chemicals, taking the 

indicated information into account, should be based on internationally recognized guidance 

(e.g. OECD) (G9: 5.3.13). 

Health effects in humans 

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 (G9: 

5.3.12). 

Effects on aquatic organisms 

Considering the deliberate discharge of Active Substances and/or relevant chemicals into the 

environment, where only data for algae, crustaceans and fish is available, for the derivation of a 

predicted no effect concentration in salt water (PNECsaltwater) a higher assessment factor than that 

for the derivation of predicted no effect concentration in fresh water (PNECfreshwater) should be 

applied, to reflect the greater uncertainty in protecting sensitive species in saltwater 

environments. Where data is available for additional taxonomic groups, for example rotifers, 

echinoderms or molluscs, the uncertainties in the extrapolation are reduced and the magnitude of 

the assessment factor applied to a dataset can be lowered. For naturally occurring Active 

Substances not meeting PBT-Criteria and being rapidly degradable, the PNEC could be set along 

the background concentration in the environmental compartment under consideration. Both acute 

and chronic data on algae, crustaceans and fish are required by the Procedure; however, because 

of their greater relevance for the situation at hand, only assessment factors based on chronic 

effects are considered. There are some circumstances where expert judgment may be applied to 

the interpretation of a dataset which may allow a pragmatic approach to the application of the 

assessment factors and the generation of new data. In each case where expert judgment is so 

applied, a full justification must be provided. 

Table 2 Effect assessment for deriving PNECs for freshwater and saltwater 

Data set Assessment factor 

Freshwater assessment 

Lowest chronic NOEC from three freshwater or saltwater 

species representing three trophic levels 

10 

Saltwater assessment 

Lowest chronic NOEC from three freshwater or saltwater 

species representing three trophic levels 

100 

Lowest chronic NOEC from three saltwater species 

representing three trophic level 

[10, 100] 

Lowest chronic NOEC from three freshwater or saltwater 

species representing three trophic levels + at least two 

chronic NOECs from additional marine 

taxonomic groups 

10 
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Effects on sediment 

Because sediment constitutes an important compartment of ecosystems it may be important to 

perform an effects assessment for the sediment compartment for those substances that are likely to 

transfer substantially into the sediment. Most of the existing whole sediment tests measure acute 

toxicity; only a few measure long-term, sub-lethal endpoints. Only the latter tests are considered 

applicable to risk assessment because of the long-term exposure of benthic organisms to sedimentbound substances that occur under field conditions. Due to the generally long-term exposure of 

benthic organisms to sediment-bound substances, long-term tests with sub-lethal endpoints like 

reproduction, growth, emergence, sediment avoidance and burrowing activity are regarded as most 

relevant. It is recommended to use pooled marine and freshwater sediment toxicity data for effect 

assessment for the sediment compartment. However, when sufficient data for ecologically relevant 

saltwater species are available, lower assessment factors can be applied. Since there are no chronic 

marine sediment test methods that are internationally accepted the results from any tests should 

always be evaluated with caution. 

Table 3 Effect assessment for deriving PNECs for sediment 

Data set Assessment factor 

Freshwater assessment 

Three chronic sediment tests with species representing 

different living and feeding conditions 

10 

Saltwater assessment 

Three chronic sediment tests with species representing 

different living and feeding conditions 

50 

Lowest chronic NOEC from three freshwater or saltwater 

species representing different living and feeding conditions 

including at least two chronic NOECs from marine species 

10 

6.3.6 Comparison of effect assessment with discharge toxicity 

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 (G9: 5.3.14). 

Predicted environmental exposure and possible effects 

For the purposes of the initial analysis referred to in point 5.2.6. of the Procedure, the ratio of the 

predicted exposure concentration of Active Substances or relevant chemicals in the treated ballast 

water at discharge and the predicted no effect concentration should be equal to or below 1 

(PEC/PNEC ≤ 1). If this condition is fulfilled, use of the Active Substance or preparations for ballast 

water treatment and subsequent discharge are acceptable without further consideration. 

However, it should be noted that due to dilution after discharge of treated ballast water, the predicted 

exposure concentration within the water compartment will be lower in the local environment (e.g. 

port area) and may be significantly lower in the marine and the coastal environment. In addition, the 

PEC after discharge might be reduced by appropriate risk management measures, e.g. by the use of a 

neutralizing agent for remaining Active Substances or preparations. Therefore, a predicted 

PEC/PNEC ratio greater than 1 (PEC/PNEC >1) in the ballast water at discharge may eventually be 

acceptable, if it is established in the risk assessment that under field conditions no unacceptable 

impact, either directly or indirectly, occurs on the viability of exposed organisms, including marine 

and estuarine organisms, due to the discharge of ballast water treated with systems making use of 

Active Substances or preparations. 
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All models and assumptions to derive a predicted exposure concentration within the water 

compartment after discharge should be stated (e.g. the effects of risk mitigation measures, 

quantities discharged, size of the receiving compartment, dilution factors, distribution etc. ñ the 

OECD Emission Scenario Document for Antifouling Paints and other publicly available 

Technical Guidance Documents might be suitable starting points). 

When no quantitative risk characterization can be carried out, for example for marine areas or 

when a PEC or PNEC cannot be properly derived, a qualitative risk characterization should be 

conducted. 

Risks to human health 

The human health risk assessment should follow generally accepted guidelines including acute 

and long-term exposure situations. The risk assessment shall entail hazard identification and, as 

appropriate, dose (concentration) ñ response (effect) assessment, exposure assessment and risk 

characterization. The population groups at risk to be examined should include crew, passengers, 

as well as personnel and the public in ports. Potential health risks connected to the exposure of 

consumers via seafood or persons at the coast (e.g. beach) after discharge should be evaluated. 

Special attention should be given to service and repair of the system by technicians and 

accidental situations on board (e.g. specific personal protection equipment). The evaluation of the 

risks to human health should include risk reduction (risk management) by regulations based on 

the SOLAS Convention as well as specific measures proposed by the manufacturer of the Ballast 

Water Management System. 

7 Assessment report (G9: 4.3) 

7.1 Quality of the test reports (G9: 4.3.1) 

7.2 Risk characterisation 

7.3 Consideration of the uncertainty associated with the assessment 

The Assessment report referred to in point 4.3 of the Procedure shall at least provide: 

• An overview of the data and endpoints on which the risk characterization according to 

section 6 of the Procedure is based 

• A risk characterization for the environment, human health, property (e.g. ship) or 

resources (e.g. fisheries) in accordance with section 6 of the Procedure 

• If any monitoring has been conducted, a summary of the results of that monitoring, 

including information on the analytical methodology used, ship movements and a general 

description of the area monitored 

• A summary of the available data on environmental exposure and any estimates of 

environmental concentrations developed through the application of mathematical models, 

using all available environmental fate parameters, preferably those which were 

determined experimentally, along with an identification or description of the modelling 

methodology 

• An evaluation of the association between the Ballast Water Management System making 

use of Active Substances or preparations containing one or more Active Substances to 

comply with the Convention in question, the related adverse effects and the 

environmental concentrations, either observed or expected based on the risk assessment 

and the effluent testing 

• A qualitative statement of the level of uncertainty in the evaluation referred to under the 

preceding paragraph 

• A detailed description of risk management possibilities, e.g. for neutralization of the 
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Active Substance in case of emergency or if PEC/PNEC at discharge >1. These 

management measures are an integral part of the Ballast Water Management System. 

8 Modification to the application 

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 (G9: 8.4.1). 

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 (G9: 8.4.2). 

9 Final approval 

Further guidance on methodology and testing and sampling for final approval to be added. 
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APPENDIX 

Key Data Summary Form for the ëProcedure 

for approval of BWM systems that Make Use 

of Active Substances (G9)í 

The proposal for approval should include information on the data set either for the preparation, 

or for each component separately (G9: 4.2.2), or for the ballast water itself in the case of in situ 

generated systems. 

Section 1: Identification (G9 4.1) 

Trade name of preparation: 

Composition of preparation, including identification of active ingredient(s): 

Ingredient (IUPAC name) Identification Numbers 

(eg CAS number) 

Percentage 

(indicating 

units, eg 

w/w, g/l) 

Active substance 

1. Other component 

2. Other component 

3. Other component, etc. 

 

Identification of any relevant chemicals (IUPAC name, CAS number): 

Section 2: Effects on aquatic organisms (G9: 4.2.1.1) 

Acute aquatic toxicity 

Test substance Species (eg 

fish, Daphnia, 

algae) 

Effect (L(E)C50; 

duration) 

Value (units); 

range 

Reference/ 

comments 

Preparation 

Active substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant 

chemicals 

 

Ballast water 

Other 

Data waivers for acute aquatic toxicity 

Species Test substance Test Reason for not 

supplying the data 

 
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Chronic aquatic toxicity 

Test substance Species (eg 

fish, Daphnia, 

algae) 

Effect (NOEC; 

duration) 

Value (units); 

range 

Reference/ 

comments 

Preparation 

Active substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant 

chemicals 

 

Ballast water 

Other 

Data waivers for chronic aquatic toxicity 

Species Test substance Test Reason for not 

supplying the data 

 

Information on endocrine disruption 

Substance Information on endocrine disruption 

Preparation 

Active substance 

Other components 

(1, 2, 3) 

Relevant chemicals 

Other 

Sediment toxicity 

Test substance Species (eg fish, 

Daphnia, algae) 

Effect [L(E)C50; 

duration; NOEC] 

Value (units); 

range 

Reference/ 

comments 

Preparation 

Active substance 

Other 

components (1, 2, 

3) 

1. 

2. 

3. 

 

Relevant 

chemicals 

 

Ballast water 

Other 

Data waivers for sediment toxicity 

Test substance Species Test Reason for not 

supplying the data 

 
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Bioavailability/biomagnification/bioconcentration 

Substance Log Pow BCF Cause 

for 

concern 

(yes/no) 

Reference/Comments 

Active substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant 

chemicals 

 

Other 

Food web/population effects 

Substance Cause for 

concern 

(yes/no) 

Comments 

Active substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

Relevant 

chemicals 

 

Other 

Section 3: Data on mammalian toxicity (G9 4.2.1.2) 

Acute Toxicity

Substance Species Method 

guidelines 

Route; dose 

levels; 

duration of 

exposure

Endpoint 

[Oral LD50; 

Dermal LD50; 

Inhalation 

LC50] 

Value (units)

Reference/ 

Comments 

Preparation 

Active 

substance 

Other 

components 

(1, 2, 3) 

1. 

2. 

3.

 

Relevant 

chemicals 

Other 
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Skin Irritation 

Substance Species Method 

guidelines 

Average 

score (24, 

48, 72 h)

Reversability 

(yes/no) 

Result Reference/ 

Comments 

Preparation 

Active 

substance 

Other 

components 

(1, 2, 3) 

1. 

2. 

3.

 

Relevant 

chemicals 

Other 

Eye Irritation 

Substance Species Method 

guidelines 

Average 

score (24, 

48, 72 h)

Reversability 

(yes/no) 

Result Reference/ 

Comments 

Preparation 

Active 

substance 

Other 

components 

(1, 2, 3) 

1. 

2. 

3.

 

Relevant 

chemicals 

Other 

Skin sensitization 

Substance Species Method 

guidelines 

(Buehler, 

M&K) 

Sensitiser 

(y/n)

Reference/Comments 

Preparation 

Active substance 

Other components 

(1, 2, 3) 

1. 

2. 

3.

 

Relevant 

chemicals 

Other 
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Repeated-dose toxicity 

Substance Species Method 

guidelines 

Route; 

Duration of 

study; dose 

levels and 

frequency 

of 

application 

Results NOAEL; 

NOEL 

(units); 

range

Reference/ 

Comments 

Preparation 

Active substance 

Other 

components (1, 2, 

3) 

1. 

2. 

3.

 

Relevant 

chemicals 

Other 

Data waivers for repeated-dose toxicity 

Test substance Test; species; route 

of exposure 

Reason for not supplying the data 

 

Developmental and reproductive toxicity 

Substance Species Method 

guidelines 

Route; 

Duration; 

doses 

Effects; NOAEL 

maternal toxicity; 

NOAEL 

embryotoxicity; 

NOAEL parental; 

NOAEL F1; NOAEL 

F2 

(units); range

Reference/ 

Comments 

Preparation 

Active substance 

Other components 

(1, 2, 3) 

1. 

2. 

3.

 

Relevant 

chemicals 

Other 

Data waivers for developmental and reproductive toxicity 

Test substance Test; species; route 

of exposure 

Reason for not supplying the data 

 
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Carcinogenicity 

Substance Species Method 

guidelines 

Route; Duration; 

doses; 

frequency of 

application 

Effects; 

NOAEL; 

NOEL (units)

Reference/ 

Comments 

Preparation 

Active substance 

Other 

components 

(1, 2, 3) 

1. 

2. 

3.

 

Relevant 

chemicals 

Other 

Data waivers for carcinogenicity 

Test substance Test; species; route 

of exposure 

Reason for not supplying the data 

 

Mutagenicity/genotoxicity 

Substance Species 

(In vitro or 

in vivo)

Method 

guidelines 

With/witho

ut 

activation; 

duration; 

concentrati

ons tested 

Results 

(positive/ 

negative)

Reference/Com

ments 

Preparation 

Active substance 

Other components 

(1, 2, 3) 

1. 

2. 

3.

 

Relevant 

chemicals 

Other 

Data waivers for mutagenicity/genotoxicity 

Test substance Test; Species; route 

of exposure 

Reason for not supplying the data 

 
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Section 4: Data on environmental fate and effect under aerobic and anaerobic 

conditions (G9: 4.2.1.3) 

Modes of degradation (biotic; abiotic) 

Hydrolysis at pH 5, 7, 9 

Test substance Test; 

duration 

pH; 

temp 

Value (units); half life Reference/ 

comments 

Active substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant chemicals 

Other 

Data waivers for hydrolysis 

Test substance Test Reason for not supplying the data 

 

Biodegradability 

Test substance Test type; 

duration; 

sea-

/freshwat

er 

Readily 

biodegradabl

e (y/n) 

Value (units); 

half life 

Identification 

of 

breakdown 

products 

Reference/ 

comments 

Active substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant 

chemicals 

 

Other 

Data waivers for biodegradation 

Test substance Test Reason for not supplying the data 

 
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Partition coefficients 

Test substance Coefficient 

(Pow; Koc; 

other) 

Test method; 

pH; temp 

Value (log units) Reference/ 

comments 

Active 

substance 

 

Other 

components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant 

chemicals 

 

Other 

Data waivers for partition coefficients 

Test substance Test Reason for not supplying the data 

 

Persistence and identification of the main metabolites 

Test substance Test; 

duration 

pH; 

temp 

Value (units); half life Reference/ 

comments 

Active substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant chemicals 

Other 

Data waivers for persistence and identification of the main metabolites 

Test substance Test Reason for not supplying the data 

 

Reaction with organic matter 

Test substance Discussion of the reaction, including 

formation of hazardous byproducts 

Reference/ 

comments 

Active substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

Relevant chemicals 

Other 
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Potential physical effects on wildlife and benthic habitats 

Test substance Physical 

description 

(state, 

solubility, 

viscosity) 

Discussion of potential effects Reference/ 

comments 

Preparation 

Active substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant chemicals 

Ballast water 

Other 

Potential residues in seafood 

Test substance Monitoring 

data/residues 

Impact on consumer safety Reference/ 

comments 

Preparation 

Active substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant chemicals 

Other 

Any known interactive effects 

Test substance Interaction 

with other 

chemicals, 

BWS, or 

receiving 

environment 

Discussion of potential effects Reference/ 

comments 

Active substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant chemicals 

Ballast water 

Other 
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Physical and chemical properties for the active substances and preparations and treated ballast 

water, if applicable (G9: 4.2.1.5) 

Property (with units 

and reference) 

Preparati

on 

Active 

substance 

Other 

components 

(1, 2, 3) 

Relevant 

chemicals 

Ballast 

water 

Melting point (°C) 1. 

2. 

3. 

Boiling point (°C) 1. 

2. 

3. 

Flammability (flash 

point for liquids; 

°C) 

 1. 

2. 

3. 

Density (20 °C; 

kg/m3

) 

 

Vapour pressure 

(20 °C; Pa) 

 1. 

2. 

3. 

Vapour density (air 

= 1) 

 1. 

2. 

3. 

Water solubility 

(temp; effect of pH; 

mg/l) 

 1. 

2. 

3. 

pH in solution 

Dissociation 

constant (log Koc) 

 1. 

2. 

3. 

Oxidationreduction potential  

Corrosivity to 

material or 

equipment 

 1. 

2. 

3. 

 

Reactivity to 

container material 

 

Autoignition 

temperature (°C) 

 

Explosive 

properties 

 

Oxidising 

properties 

 

Surface tension 

Viscosity 

Thermal stability 

and identity of 

breakdown 

products 

 
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Other physical or 

chemical properties 

 1. 

2. 

3. 

 

Shaded cells, data not required 

Salinity, TOC, DOC, and % particulate matter are required for the ballast water used in type approval testing. 

Analytical methods at environmentally relevant concentrations (G9: 4.2.1.5) 

Substance Analytical method; conditions; 

applicability (water/sediment) 

Sensitivity Reference/ 

comments 

Preparation 

Active substance 

Relevant chemicals 

Other 

Use of the preparation 

Brief description of the handling storage and use: 

Material safety data sheets 

Substance Provided 

(yes/no) 

Classification according to GHS Reference/ 

comments 

Preparation 

Active substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Other 

Risk characterisation 

Substance Persistent (y/n) Bioacumulative 

(y/n) 

Toxic (y/n) Reference/ 

comments 

Preparation 

Active substance 

Other 

components (1, 2, 

3) 

1. 

2. 

3. 

 

Relevant 

chemicals 

 

Other 

Evaluation of the treated ballast water 

Conclusion of the half-life of the toxicity of the treated ballast water, and the recommended 

holding time. 

Risk characterisation 

Conclusion on the effects of reaction with organic matter 

Conclusion of persistence 
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Conclusion on the discharge concentration 

Conclusion on the potential for bioaccumulation 

Conclusions on the effects assessment 

Human health 

Aquatic organisms 

Sediment 

Conclusion of the comparison of effect assessment with discharge toxicity 

* * * 
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ANNEX 5 

REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES - 

SUBMITTED BY GERMANY 

(PERACLEAN OCEAN) 

The basis for the groupís evaluation of PERACLEAN OCEAN was the application 

dossier submitted by Germany. No further data sources were consulted. 

1 Completeness of the dossier 

The application dossier is not considered to be complete as the following information is missing: 

• A detailed description of the intended application on-board ships allowing full evaluation 

of the safety to ship and crew 

• Data on realistic occupational exposure scenarios are required in order to characterize 

human health risk of use and handling. 

• Justification for use of scenarios for modelling environmental exposure concentrations 

• Tests with treated Ballast Water on more species, including long-term data 

• Justification for non-submission of data 

2 Identity 

Preparation data 

PERACLEAN OCEAN consists of the following components (approximate concentrations): 

• Peracetic acid (PAA) [79-21-0] H3CñC(=O)-O-OH 14 - <17% 

• Hydrogen peroxide [7722-84-1] HñOñOñH 13 - <15% 

• Acetic acid [64-19-7] CH3-COOH 24 - <29% 

• Water H2O <39 - 49% 

Peracetic acid is the Active Substance, which is in a dynamic equilibrium with hydrogen 

peroxide in both the formulated preparation and in ballast water during use. Peracetic acid is a 

strong oxidising agent with a non-specific mode of action. 

PERACLEAN OCEAN is specified as scheduled in the IMDG Code under UN No. 3109, 

organic peroxide Type F, liquid, with a classification of 5.2. 
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Physicochemical properties 

Property PAA H2O2 Acetic acid 

Molecular weight 76.05 34.02 60 

Physical state Clear, colourless liquid Clear, colourless liquid Clear, colourless liquid 

Melting point [ ̊C] -50 -0.40 -16 

Boiling point [ ̊C] > 60 150 (d) 100 

(Relative )density 

[kg/m3

] 

1150 1442.5 1050 

Vapour pressure [Pa] 1.1 10-5 300 1570 

Solubility [g/L] 1000 Miscible Miscible 

Log Kow -0.52 -1.5 -0.23 

pKa 8.2 11.62 

Viscosity 

Henryís law constant 5 10-12 4.5 10-6 5.4 10-4 

Flash point [ ̊C] 96 40 

Autoignition temperature 

[ ̊C] 

265 485 

Flammability Flammable 

Explosive properties Not explosive 

3 Application 

The recommended application of PERACLEAN OCEAN is a concentration of 150 mg/L in the 

ballast water for a minimum period of 1 day and for preferably a period of 2 days. 

The submission informs PERACLEAN OCEAN is applied to the ballast water by an automated 

dosing system that addresses the variations in flow rates of ballast pumps. The product is dosed 

after a two stage filtration process designed for pre-separation of solids above 50 μm. 

4 Human health hazards 

PERACLEAN OCEAN is a preparation used for Ballast Water disinfection whose biocidal 

activity is based on peroxygen mechanism due mainly to the physical-chemical properties of the 

peracetic acid (PAA) and hydrogen peroxide. Whenever possible, and preferably, the 

toxicological evaluation should be based on the evaluation of the preparation test results. 

Hazard classification for PAA at 15% as in the Annex I to Dir 67/548/EEC: 

C; R20/21/22-35 

It is a severe corrosive to skin and eyes, harmful by inhalation, if swallowed, and in contact with 

skin. Irritant to mucous membranes of the respiratory tract. 

Hazard classification for H2O2 at 14.3% as in the Annex I to Dir 67/548/EEC: 

Xn; R22-41 

It is considered harmful if swallowed and a there is a risk of serious damage to eyes. 

Classification information reflects hazard and does not take account of potential exposure. 
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Acute toxicity 

Route of exposure LD 50 or LC50 Species Reference 

Oral 

(15% PAA) 

1021 mg/kg bw Rat Degussa, 1982 

Dermal 

(15% PAA) 

1957 mg/kg bw Rabbit Kuhn, 1996 

Inhalation, aerosol Ca 0.5-1.3 mg/L/4h Rat Terrell, 1986 

The test results mentioned in the presented studies confirm that the preparation is harmful by oral 

and dermal routes and it is considered toxic by inhalation. However, the Group agreed to take 

into consideration that, as PAA is highly unstable, there were difficulties in generating a stable 

atmosphere and therefore accurate measurements of the test atmosphere and droplets of aerosol 

were difficult to achieve. In these circumstances, LC50 value should be used with caution. 

During the observation periods from the referred studies the commonly reported adverse effects 

were related to irritation of skin (dermal route) and to mucous membranes either from the 

gastrointestinal tract (oral route) or the respiratory tract (inhalation route). The clinical and 

pathological signs were presumably associated with these inflammatory reactions. According to 

the reports, these effects were considered to be local (near the point of contact), depending on the 

concentration applied, and not inducing systemic toxicity. 

Additionally, in a dermal acute study (Kuhn 1996), reported signs of toxicity (nasal discharge) 

could be attributed to systemic effects at high dose levels. However, it is likely that in this 

particular study these signs were caused by additional inhalation exposure. 

It is considered that PAA due to its intrinsic physical-chemical properties ñ log P<0, high water 

solubility and high hydrolysis rates at pH near 7 (body pH) - and in case of damaged skin, can 

efficiently diffuse through the internal membranes and be absorbed in the cells. This process is 

assumed not to induce target organ toxicity, perhaps with exception of stomach ñ where pH is 

around 2 and PAA can be stable ñ nor bioaccumulate as the parent compound will rapidly be 

absorbed, distributed in the body fluid and metabolized by catalases into HOAc and H2O and 

O2, being further eliminated by the different routes (urine, faeces and exhaled air). 

Effects on skin and eye 

Skin irritation 

A study was performed according to OECD TG 404 to address skin irritation (Degussa, 1990). 

After one single application of 0.5 ml PAA 15% in skin rabbit, 4 h of occlusive exposure, the 

results were indicative of severe corrosiveness. 

Skin sensitization 

No skin sensitization was observed in two Buhler tests in guinea pigs with different formulations 

of PAA (5% and 12%). In one guinea pig maximisation test, a positive result was claimed but the 

report does not permit critical evaluation of the results (ECETOC JACC N 40, 2001). 
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Eye irritation 

A study from Cascieri and Freeman (1983) was submitted by the applicant to address this 

endpoint, where 17% PAA was tested in rabbit eyes and found to be extremely irritant to washed 

and unwashed eyes. A classification of ësevere irritantí was determined. 

Irritation to the respiratory tract 

An acute inhalation test was performed by Janssen (1989) to investigate irritating properties of 

nebulised PAA 15%. The RD50 referring to a concentration of PAA inducing a 50% reduction of 

respiratory rate was calculated to be 21.5 to 24.1 mg/m3. After exposure the respiratory rates 

returned to normal and the animals recovered fully within 3 days. No other clinical signs and no 

histopathological changes were observed. 

Repeated Dose Toxicity 

An oral sub-chronic study (90 d) in rats with PAA 5% (CEFIC, PAR, 2003).was submitted by the 

applicant in order to investigate the toxic effects resulting from repeated dose administration. 

Clinical and histopathological data suggest local acute irritant effects on trachea and lungs 

attributed to gavage administration rather than systemic effects. The findings are in accordance 

with the toxicokinetics weight of evidence and support that PAA will not be systematically 

available beyond the site of first contact. 

According to the test conditions, a NO(A)EL (no observed adverse effect level) at 5 mg/kg 

bw/day was identified based on local irritant effects. By extrapolation, this value would 

correspond approximately to 1.7 mg/kg bw/day of PAA 15%. Applying an assessment factor of 

100 for intra- and interspecies variability, a NO(A)EL (humans) of 0.017mg/kg bw/day could be 

estimated. However, due to deficiencies relating to the stability of the test substance during the 

experimental period and to the uncertainty inherent to extrapolation calculations, this value 

should be considered with caution. 

Several sub-chronic studies mentioned in the literature report effects arising from oral, dermal or 

inhalation exposure to PAA that seem to be related with local irritation at the site of contact. 

However, some systemic effects on liver, kidney and perhaps spleen (significative differences in 

white blood cells counting) cannot be ruled out and therefore no clear NAEL can be derived from 

available studies (ECETOC JACC, N40). 

From the overall assessment of acute and sub-chronic effects, it should be recommended that the 

irritation effects in the respiratory tract triggered in some inhalation studies (Janssen, 1989; 

Janssen and Van Doorn, 1994) should be further investigated in a repeated dose inhalation study 

in order to assess the toxicity of the substance at lower dose exposure. Additionally, a dermal 

absorption study in vitro with non damaged skin at lower doses (diluted concentrations) should 

be conducted to anticipate the risk of occupational exposure in non accidental situations. 

Mutagenicity/Genotoxicity 

The evaluation of the battery of genotoxic and mutagenic tests submitted by the applicant, 

coming from literature search and using different concentrations (%) of the test substance, gives 

limited information on the effects of PAA on DNA and its potential to induce gene and 

chromosome mutations both in vivo and in vitro. Several bacterial tests were presented but due to 

cytotoxic effects at higher doses resulting from the biocidal nature of PAA, these are of limited 

value for appraisal of these effects. However, as a general conclusion the Group can accept at this 

stage that PAA doesnít show a significant potential concern for mutagenicity/genotoxicity. 
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Chronic and long term toxicity, developmental and reproductive toxicity, carcinogenicity 

The applicant submitted a justification for non-submission of the following studies: 

• sub-chronic toxicity study with a second species 

• chronic toxicity study 

• developmental and reproductive study 

• carcinogenicity study 

The argument presented in the justification for non-submission was the fact that by testing PAA 

was proven to be not systemically available and therefore unable to reach specific organs. 

This justification can be accepted at this stage based on specific toxicokinetics and also the fact 

that there is limited reliable information available concerning the testing of these endpoints 

(chronic or carcinogenicity studies, teratogenic and multigeneration studies), and doesnít allow a 

critical assessment of the potential for toxicity of these health effects (ECETOC JACC, N 40, 

2001). 

5 Risks to safety of ship and crew 

The submission states that PERACLEAN OCEAN is safe to the ship and crew during normal 

operation provided the manufacturersí procedures are followed. As the dosing is fully automated, 

no crew handling of the chemical is required. However, due to the inherent dangerous properties 

of PERACLEAN OCEAN in its undiluted form many different safety measures are essential to 

reduce risks to a level that may be acceptable and permit its use on-board ship. 

PERACLEAN OCEAN is classified as corrosive and oxidizing. Under the influence of heat or 

catalytically active substances it is liable to rapid exothermic decomposition and decomposes into 

water, acetic acid, and oxygen. If ingested or inhaled it has a severe caustic effect. In contact 

with the skin or eyes it is considered severely corrosive. It reacts on contact with iron, copper, 

brass, bronze and zinc and may react with organic substances causing fire. It must not be 

brought into contact with combustibles, greases, or oils. It must be protected from direct sunlight 

and stored away from all sources of heat in a well ventilated area. 

PERACLEAN OCEAN is recommended to be stored in free-standing firmly installed tanks of 

volume up to 50m3

 constructed of special grade stainless steel, or in exchangeable containers, in 

a well ventilated independent compartment, depending upon the space availability on deck or 

below deck. The storage room should be of fireproof and seamless construction with an acid 

resistant floor. PERACLEAN OCEAN must not be confined in vessels, piping systems, or 

between valves. There must always be pressure release, such as a rupture disc, or breathing 

devices fitted to any volume that can be closed. For storage tanks a pressure release of at least 

100 cm2 per metric tonne is required. The storage temperature should not exceed 35 0C. A 

device should be provided for rapid overboard discharge of the storage tank in case of 

emergency. The amount stored should be kept as low as reasonably practicable. Exposure to 

any external source of heat is to be prevented. Connection to containers is identified as a 

particular hazard to personnel and the use of personal protective equipment including a full 

chemical protective suit and respiratory protection is required for this task and in accidental 

situations. 

The requirement for a storage temperature below 35 0C without the use of a temperature 

controlled atmosphere will preclude the use of this product in some areas, particularly where 

tropical conditions may be encountered. Positioning of storage space ventilation outlets will 
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require careful consideration to avoid risk to personnel should any spillage or operation of the 

pressure release device occur. As compatibility of materials is essential, then the overboard 

emergency discharge arrangements will require particular consideration. It is worthy of note that 

the IMDG Code requires transport of this type of commodity on deck only. 

Only suitable stainless steel should be used for piping, hose lines, fittings, seals and pumps. All 

transmission piping must be easily accessible and welded in one piece whenever possible. 

It is envisaged that storage in the engine-room will not be possible due to both safety and 

temperature reasons; therefore a long supply pipe to the dosing unit will be necessary. Even 

though the submission states that due to the automated process in ballast water application and 

dosing, personnel exposure is unlikely to occur during the treatment operations, leakages will 

always be of concern and the routing of the supply pipe away from all sources of heat such as 

engine exhaust arrangements and steam piping will require care, particularly as the product 

decomposes at temperature greater than 60 0C Flushing arrangements for the supply piping and 

dosing system will need to be considered to permit maintenance without the possibility of 

spillage or leakage of the chemical to the engine room. It is recommended that extraction 

ventilation is provided by way of the dosing unit to remove traces of a possible vinegar smell 

(acetic acid); this may be problematic where the dosing unit is arranged in the engine-room as 

positive pressure ventilation is an engine-room norm. It will be necessary to provide venting 

arrangements for the supply piping or other breathing devices to outside the engine room to avoid 

potentially dangerous contaminations. Personal protective equipment including respiratory 

protection, hand protection, eye protection, acid proof clothing and rubber or plastic boots will 

require to be supplied ready for use in locations where there is any possibility of spillage or 

leakage. 

As PERACLEAN OCEAN is a strong oxidizing agent and highly reactive; fire will always be a 

concern. The potential for leakage to bilges contaminated with oils must be considered. 

Automatic sprinkler systems should be located above the storage tank and dosing section, and 

fire fighting instructions recommend the use of positive pressure breathing apparatus. 

The recommended safety precautions such as the use of positive pressure breathing apparatus and 

full chemical personal protection are not normally encountered on ships other than specialized 

chemical carriers. In consideration of the risks that may be encountered in the use of this 

product, it may be appropriate to require additional training in the use of dangerous chemicals for 

crewmembers to that available from the supplier, such as that provided by the dangerous cargo 

endorsement for chemicals. 

The submission states that tests with diluted PERACLEAN OCEAN show no damage to standard 

epoxy tank coatings. It is recommended that the corrosive effect is monitored for confirmation of 

this statement. As the substance is highly reactive with zinc, further confirmation that use of this 

product is permissible where the ships ballast system piping is internally galvanised is necessary. 
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6 Environmental fate and exposure 

Fate and behaviour properties 

Property PAA H2O2 Acetic acid 

Hydrolysis 

pH4 DT50 = 48 h - 

pH7 DT50 = 48 h Variable but 

short 

- 

pH9 DT50 = 3.6 h - 

Photolysis - - 

Degradation in seawater DT50 = 7ñ20 min DT20 = 25-35 

min 

- 

Ready biodegradation > 70% n.p. > 70% 

Biodegradation Rapid DT50 = 21h ñ 5d - 

Sorption Very low Very low Very low (e.j.) 

Bioconcentration No No No 

Anaerobic degradation - - - 

 

Fate in ballast water tanks 

The prescribed optimum dosage of PERACLEAN is an initial concentration in the ballast water 

at 150 mg PERACLEAN/L corresponding to initial concentrations of peracetic acid of 23 mg/L, 

hydrogen peroxide of 21 mg/L and acetic acid of 38 mg/L. 

After application in ballast water, a complete decay of peracetic acid was observed after 10-15 

hours of exposure. Hydrogen peroxide degrades more slowly. 

According to the available dossier, three different experiments have been conducted for 

simulating degradation in ballast water. 

In one experiment with application of 150 mg Peraclean/L to filtered clean seawater (low 

concentration of POC/DOC), the concentrations of hydrogen peroxide were measured to 20 mg/L 

after 5-10 hours and 15 mg/L after 50 hours of exposure corresponding to a degradation of 

approximately 25%. In another experiment with dosing Kiel Harbour water with 17.2 mg/L resp. 

30 mg/L, the H2O2 concentrations after 24 hours were 1.4 ñ 2.5 mg/L depending on the initial 

concentrations (corresponding to approximately 92% degradation in 24 hours). The amount of 

H2O2 at the end of the BW treatment seems to be proportional to the amount of organic matter in 

the water. 

Assuming a minimum holding time of 2 days according to use specifications, a maximum 

content of hydrogen peroxide of 15 mg/L may be used as the basis for further evaluation of 

environmental fate and effects. 
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Fate in the environment 

After discharge of ballast water to the aquatic environment, hydrogen peroxide will undergo 

further degradation in the water phase. Based on the physicochemical properties of the substance, 

no significant sorption to particulate or organic matter is expected and neither is volatilisation. 

For the long-term assessment, the applicant uses the MAMPEC model to estimate PEC in port of 

Rotterdam and also to assess the worst case without the effect of degradation of active substance 

after discharge. There are no data documenting the discharged concentration of active substances 

used in the model and the model is documented neither in the report nor in the dossiers. It is 

therefore difficult to control the calculated PEC values used in the table below. 

Discharged volumes are presented in document MEPC 53/2/12 (approximately 390,000 ton/day). 

The total load of H2O2 used in the MAMPEC model is given to be 30 kg H2O2/day from the 

ballast water. The concentration in the discharged ballast water can from this be calculated to be 

0.077 mg H2O2/l. 

Without more details about the input data to the model and a documentation of the model, it is 

difficult for the Group to accept the presented PEC. 

7 Environmental hazards 

7.1 Short-term and long-term aquatic toxicity test data are available for peracetic acid (PAA), 

hydrogen peroxide and the preparation PERACLEAN OCEAN with a range of marine and 

freshwater species. 

Peracetic acid (PAA) 

The group considers that the following studies are the key studies for peracetic acid: 

• Fish acute toxicity, 96 h LC50 = 1.6 mg/L2

 (rainbow trout) 

• Fish chronic toxicity, 7 d NOEC = 1.9 mg/L (survival of Menidia) 

• Crustaceans acute toxicity, 48 h EC50 = 0.5 mg/L (Daphnia) 

• Crustaceans chronic toxicity, 21 d NOEC = 0.05 mg/L (Daphnia reproduction) 

• Algae growth, 72 h NOEC = 0.074 mg/L 

• Bivalve acute toxicity, 48 h EC50 = 0.27 mg/L (blue mussel larvae) 

The Group noted some errors in the summary dossier, e.g. Macomona lilliana is not a fish, but a 

bivalve (shellfish) and the effect concentrations for Mytilus edulis are in mg/L and not in mg/mL. 

Based on the available test data, a Predicted No-Effect-Concentration for long-term exposure can 

be derived using an assessment factor of 10 to the lowest effect data resulting in PNEC = 0.007 

mg PAA/L. However, the Group noted that PAA does not persist long in the environment. 

 

2

 The test data are difficult to interpret and the effect concentration may refer to a 5% PAA solution corresponding to 

a LC50 = 0.08 mg PAA/L. 
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PAA is degraded almost completely after less than 24 hours. The Group has therefore based its 

consideration/assessment on the presence of a residual concentration of hydrogen peroxide 

(H2O2) as the most relevant substance contributing to the toxicity. 

Hydrogen peroxide (H2O2) 

Considering the toxicity criteria for identification of PBT substances in Table 1 in the G9 

Guidelines (Chronic NOEC < 0.01 mg/L) and the EC50/NOEC data for the most sensitive 

organism presented in the submitted dossier (table below), it can be concluded that H2O2 and 

thereby the PERACLEAN itself are not considered to be toxic. 

H2O2 toxicity values for the most sensitive organism (Source: DEGUSSA AG March 15, 2005, risk 

characterization In: Request for approval of PERACLEAN OCEAN for ballast water Treatment, Assessment 

report) 

Taxonomic 

group 

Species Endpoint Result Reference

Fish Pimephales 

promelas 

Mortality LC50 (96h): 16.4 mg/L EU 2003 

Crustaceans Daphnia magna Immobilisation EC50 (24h): 2.3 mg/L EU 2003 

Algae Skeletonema 

costatum 

Growth 

inhibition 

EC50 (72h): 1.38 mg/L 

NOEC (72h): 0.63 mg/L 

EU 2003 

- Chlorella vulgaris Growth 

inhibition 

EC50 (72h): 2.5 mg/L 

NOEC (72h): 0.1 mg/L 

EU 2003 

Snail Physa sp. Mortality EC50 (96h): 17.7 mg/L EU 2003 

Bivalve Dreissena 

polymorpha 

Mortality LC30 (56d): 5 mg/L 

NOEC: 2 mg/L 

EU 2003 

- Mytilus 

galloprovincialis 

Mortality & 

development 

EC50 (48h): 1.58 mg/L 

NOEC (48h): 1.25 mg/L 

Dossier 

In the EU risk assessment report, a PNEC of 10 μg/L was derived. The applicant, however, 

considers this value to be very conservative due to a number of reasons. 

8 Environmental risks 

PBT assessment 

The following properties of the components of PERACLEAN OCEAN are found: 

 Persistence Bioaccumulation Toxicity 

Peracetic acid Very quickly 

degradable 

Log Pow = -0.52 NOEC = 0.07 mg/L 

Hydrogen peroxide Readily biodegradable Log Pow = -1.5 NOEC = 0.1 mg/L 

Acetic acid 

None of the components of PERACLEAN OCEAN fulfils any of the three PBT criteria and 

consequently, none of the components are assessed to be PBT substances. 

Toxicity of treated ballast water 

Short-term aquatic toxicity test with ballast water sampled immediately after treatment and 48 

hours after treatment have been conducted with bivalve larvae (Mytilus galloprovincialis). In 

addition, as the treatment resulted in a change of the pH in the ballast water, a test was conducted 

with a pH-adjusted sample. 

The following results of the toxicity tests were obtained: 
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• Freshly treated sample, EC50 = 2.4% 

• Treated sample (48 hours storage), EC50 = 18.6% 

• Treated sample (48 hours storage, pH adjusted), EC50 = 17.6% 

Thus, the toxicity of the ballast water decreased by 86% during 48 hours of treatment. Assuming 

a concentration of 15 mg/L of hydrogen peroxide after 48 hours treatment, the EC50 determined 

corresponds to a concentration of hydrogen peroxide at 2.5 mg/L. This corresponds to the EC50 

determined in the same test with hydrogen peroxide at 1.6 mg/L. 

Environmental risk assessment 

The test system used for testing the toxicity of treated ballast water was chosen by the applicant 

as it was among the most sensitive of species tested with hydrogen peroxide. Short-term toxicity 

to other species incl. algae seems to be at the same level. Taking the toxicity of the treated ballast 

water as well as the toxicity of hydrogen peroxide to aquatic species into account the Group 

considered that some acute impact may be expected in the surrounding area of the discharge 

depending on the amount of organic matter and suspended solids in the ballast water to be treated 

and the dilution processes occurring in the receiving environment. 

The environmental risk of the estimated and measured concentrations of hydrogen peroxide in 

treated ballast water has been assessed as well. The application report concludes that the 

calculated PEC of H2O2 is lower than PNEC as presented in the table below. 

The Group calculated also PEC/PNEC ratio considering the toxicity data for the most sensitive 

organism (see table below) and other information from the dossier. The H2O2 PNEC in water 

proposed by the EU (in EU, 2003, Hydrogen Peroxide, Summary Risk Assessment Report) is 10 

μg/L. In the calculations the Group used both conservative and non-conservative PEC values as 

provided in document MEPC 53/2/12 included in the dossier. The PEC/PNEC ratios are 

presented in the table below. 

PEC/PNEC for H2O2 discharged 

Source PEC 

(μg/l) 

NOEC 

(μg/l) 

Assessment 

factor 

PNEC(μg/l) PEC/PNEC 

MEPC 53/2/12 

(worst case scenario 

with H2O2 

degradation) 

4.9 100 10 10 0.49 

MEPC 53/2/12 

(worst case scenario 

without H2O2 

degradation) 

9.9 100 10 10 0.99 

If we accept the PEC values calculated with the MAMPEC model, the Group can conclude that 

for the long term the risk of discharge will be acceptable even for the high concentration at 

discharge. However, as mentioned above, the use of the MAMPEC model as well as the scenario 

and input parameters have not be sufficiently justified in the dossier. 
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9 Conclusions and recommendations 

Upon application of PERACLEAN OCEAN in ballast water, the PAA is degraded almost 

completely after less than 24 hours. Hydrogen peroxide, however, degrades more slowly with the 

degradation rate depending on the content of organic matter and particles in the ballast water. 

Applying the recommended dosing of 150 mg/L PERACLEAN OCEAN, a typical concentration 

of hydrogen peroxide at 2 mg/L may be expected in the discharged ballast water. In cases where 

ballast water has a low content of organic matter and particles, and where the holding time is 

short (48 hours or less), concentrations of up to 15 mg/L of hydrogen peroxide may be expected. 

Aquatic toxicity testing with treated ballast water shows that the acute toxicity encountered can 

be ascribed mainly to the content of hydrogen peroxide. It is further noted that even with the 

lowest concentration of hydrogen peroxide in the treated ballast water (2 mg/L), a dilution of the 

discharged ballast water of at least 200 times is required to reach environmental concentrations 

below the Predicted No-Effect-Concentration at 10 μg/L according to the EU Risk Assessment 

Report available. 

Exposure modelling has been performed using the MAMPEC model. The assumptions on the 

scenarios as well as input parameters of the model are not presented in detail, which hinders the 

evaluation of the reliability of the model results. It appears from the dossier that resulting 

concentrations in the aquatic environment after discharge and dilution are at the maximum of 5-

10 μg/L of hydrogen peroxide which is lower than or equal to the PNEC value established. Thus, 

the application and discharge of PERACLEAN OCEAN seem to cause no unacceptable harm to 

the environment. 

Based on the above evaluation and conclusions, the Group recommends that a basic approval of 

the use of PERACLEAN OCEAN as a ballast water biocide should be given. However, the fullscale testing as well as an eventual application for a final approval should consider a number of 

issues: 

• A number of concerns in relation to safety of ships have been raised in section 5 due to 

the physico-chemical hazards of PERACLEAN OCEAN. These concerns need to be 

addressed prior to initiation of full-scale testing onboard ships. 

• Based on the submitted scientific information about the toxicological profile of PAA 15% 

preparation, we can anticipate major concerns towards acute adverse effects 

(corrosiveness, severe irritant for skin and eye, irritant for the respiratory tract). In this 

sense, we recommend as mandatory the application of RMM (risk management measures) 

for the protection of the exposed populations to the main routes of concern: dermal and 

inhalation. These control measures (PPE and RPE) must be put in place for use and 

handling of the preparation at the different stages of the process and with the different 

concentrations applied. 

• Additionally, it is recommended that dermal and inhalation sub-chronic effects in 

presented studies should be further investigated, taking into account realistic occupational 

exposure scenarios and covering non-accident situations. These data should be submitted 

before final approval. 

• There seems to be insufficient information on degradation of components of 

PERACLEAN OCEAN during treatment of ballast water as it seems to depend on the 

content of organics and particles in ballast water. This should be further studied and 
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reliable estimates or measurements of concentrations of the components at discharge 

should form the basis for the environmental risk assessment. 

• The selection of appropriate scenarios for discharge of treated ballast water needs 

consideration and justification. This would include proposals for numbers of ships in the 

harbour, the volume of treated ballast water, the frequency and duration of discharges, the 

dimensions of the harbour including water volume and flow. The Group notes that this is 

not necessarily an obligation of the individual applicant, but that this might be considered 

at a general level (cf. the report of the BWWG 1 meeting). 

• Based on the updated information, a revised environmental risk assessment needs to be 

submitted for a final approval. 

However, after a careful evaluation of the available information, the Group recommends that 

a basic approval is issued allowing a full-scale development and testing. 

* * * 
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ANNEX 6 

REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES 

- SUBMITTED BY REPUBLIC OF KOREA 

(ELECTROCLEAN) 

ELECTRO CLEAN evaluation report 

The basis for the Working Groupís evaluation of ELECTRO CLEAN system (ECS) was the 

application dossier submitted by the Republic of Korea. Further data sources were found in the 

IUCLID data base hosted by the European Commissionís European Chemicals Bureau. 

1 Completeness of the dossier 

The application dossier is not considered to be complete as the following information is missing: 

• Effects of the maximum total residual chlorine (TRC) concentration (20-30 mg/l) and also 

a quantitative risk assessment to the environment. 

• Information on the reliability and accuracy of the control scheme. 

• The dossiers do not provide any data on the corrosivity of the treated ballast water. 

• Data on human exposure to the active substances not allowing risk evaluation of use and 

handling 

• Justification of non submission of data 

• Calculation of the predicted environmental concentration (PEC) in the dossier and in 

document MEPC 54/2/3 are based on the MAMPEC modelling from the German 

application. The Group had several comments to the MAMPEC model results and further 

pointed out that to use these without access to the input data does not produce any 

valuable data. The calculated PEC values are therefore only used as indicative estimates 

in this assessment. 

2 Identity 

Physicochemical properties 

Property Cl2 HO⋅ HOCl 

Molecular weight 70.906 17 52 

Physical state Gas NA liquid 

Melting point [ ̊C] -101 NA -6 

Boiling point [ ̊C] -35 NA 40 (d) 

(Relative) density [kg/m3] 3.214 [g/m3] NA 1.1 

Vapour pressure [Pa] 6.8 105 NA NA 

Solubility [g/L] 14.6 NA Miscible 

Log Kow NA -3.42 

pKa NA 

Viscosity [cP] NA 0.01327 

Henryís law constant [-] NA 

Flash point [ ̊C] NA 

Auto ignition temperature 

[ ̊C] 

 NA 

Flammability NA 

Explosive properties NA 

NA = not applicable (d) = decomposition at indicated temperature 
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3 Application 

The submission informs of Electro-Clean technology which disinfects ballast water by 

electrolysis. Disinfection is carried out directly from the electrical potential and from the 

generation of free chlorine, sodium hypochlorite and hydroxyl radicals, and by electrochemical 

oxidation through the creation of ozone and hydrogen peroxide. No chemicals are required to be 

stored on board as the active substances are produced electrically in-situ from the uptake of 

ballast water within the electrolysis module by fully automatic operation using a remote 

monitoring/control system. A pre-filter is used to remove larger solids. 

In this system, the generated initial concentrations of active substances are controlled by applied 

current density to the flow cell of the electrolysis cell. And the volume directly influences the 

TRC concentration at discharge and environmental risks. In the background documents, planned 

to set the ìsensorî at the exit point of the system before ballast tank and monitors the value, 

which is used for the control parameter of the systems. But there is no description about the 

sensor; directly measuring TRC, or some indirect sensor for ORP, etc. 

It is not clear to the Group whether or not the ELECTRO CLEAN system (ECS) is able to 

function if freshwater is used as ballast water. 

4 Human health hazards 

The active substances Cl2, HOCl, OClñ, and OH radicals are produced electrolytically in situ and 

presumably have a very short-life. 

The biocidal efficacy of the formulation is considered to be a result of its equilibrium formulation 

which in fact is regulated by the equipment itself. It is considered to be a preparation whose 

efficacy to be attained must be permanently monitored. Toxicological data presented by the 

applicant are disperse and relating to different concentrations of the different compounds 

involved in the disinfection process whose composition in the equilibrium solution includes free 

chlorine, sodium hypochlorite and hydroxyl radicals. 

Table Qualitative health effects assessment relating to the compounds existing in the equilibrium 

solution (Hypochlorite, Chlorine, Hydroxyl radicals) 

Main compounds in the equilibrium solution 

Human health 

endpoints 

Hypochlorite Chlorine Hydroxyl radicals 

Acute toxic effects 

Oral Irritation, pain, 

inflammation of mucoses. 

In severe cases causes 

ulceration and perforation 

of gastro intestinal tract. 

Health effects depend on 

several factors: amount, 

concentration and pH of 

the solution 

Irritant effects Systemic toxicity of 

hydroxyl ions 

confounds with 

elevated blood pH. 

Normal pH of blood is 

7.35. The alkalosis 

causes hyperactivity to 

the central nervous 

system with above pH 

7.8, tetanus, extreme 

excitability. A shortterm mechanism is the 
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Main compounds in the equilibrium solution 

Human health 

endpoints 

Hypochlorite Chlorine Hydroxyl radicals 

respiration 

compensation. A longterm mechanism is the 

renal compensation. 

Dermal Mild irritation to corrosive 

injury depending on the 

concentration 

Irritant effects 

Inhalation Vapours are not easily 

formed however with more 

concentrated solutions and 

high pH or if mixed with 

acids higher % of chlorine 

may be released causing 

mild to severe irritation of 

nose and throat. Lethal 

effects can also occur, 

derived from aspiration of 

sodium hypochlorite 

solution into the lungs 

This is the major route 

of concern, chlorine 

gas vapours are heavy 

and settle down in low 

areas 

Irritant effects; acute 

inflammatory effects 

towards the 

respiratory tract 

Effects on skin 

and eye 

 

Skin irritation Can cause mild irritation to 

corrosive injury depending 

on the duration of contact, 

concentration and pH of 

the solution

Acute inflammatory 

effects 

Skin sensitization Negative results have been 

obtained for 8% sodium 

hypochlorite solution; 

insufficient information 

available to characterize 

this endpoint 

 

Eye irritation Mild irritation to corrosive 

injury depending on the 

concentration and pH of 

the solution and on the 

duration of contact, as 

well. If warmed at higher 

temperature can release 

significant amounts of gas 

which is a severe eye 

irritant 

Acute inflammation 

effects towards cornea 

and conjunctiva 

Irritation to the 

respiratory tract 

Hypochlorite does not easily 

form vapours however in 

more concentrated solutions 

and at high pH, mists that 

Acute effects 
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Main compounds in the equilibrium solution 

Human health 

endpoints 

Hypochlorite Chlorine Hydroxyl radicals 

form can cause mild to 

severe irritation of the nose 

and throat 

Repeated Dose 

Toxicity (90 d) 

Not available Not available Not available 

Toxicokinetics It was shown that 

hypochlorite does not 

accumulate in the body, it 

reacts with tissues and 

apparently is readily 

absorbed in serum and 

eliminated from plasma with 

half-life of 44 h. 

Chronic and long 

term toxicity 

health effects 

From the applicants report it 

was not possible to conclude 

if the substance is an 

occupational skin sensitizer; 

however some sporadic 

cases are reported. 

May cause dyspnea, 

palpitations, chest pain 

reactive, upper airways 

dysfunction syndrome 

Chronic exposure to 

chlorine gas is one of 

the most frequent 

causes of occupational 

asthma 

Mutagenicity/Gen

otoxicity 

Has not been suggested as 

mutagenic according to 

available information. 

However, some effects 

concerning sperm shape 

have been recorded 

Developmental 

and reproductive 

toxicity 

No specific conclusions 

about the potential for 

developmental toxicity in a 

chlorinated drinking water 

study. 

There is insufficient 

information to draw 

conclusions. However, some 

indicative effects of altered 

sperm shape have been 

detected 

Chlorine was 

considered teratogenic 

in experimental 

animals 

Carcinogenicity It is not classified by IARC. 

In most studies there is a 

lack of statistical evaluation 

of the results and lack of 

dose-response relationship 

Lymphoma has been 

observed in relation to 

water treatment with 

chlorine. Associations 

with increased renal, 

bladder and gastric 

cancers have been 

registered 
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From the above information it is concluded that the main health effects are acute in nature; 

however some concerns are addressed related to the reproductive system under long term 

exposure scenarios. 

5 Risks to safety of ship and crew 

The submission states that the application of Electro-Clean technology is safe to the ship and 

crew during operation as the level of active substances produced is below recognised standards 

for dangerous substances, and that the active substances generated remain within the closed 

ballast water system. 

The dossier presented refers to tests with simulated ballast water indicating that Trihalomethane 

(THM) discharges remain within acceptable limits. The residual chlorine levels immediately 

following treatment are given as being in the range of 10ñ30 parts per million. Other studies 

have suggested that THM is formed from the breakdown of chlorine and organic matter and that 

THM generation increases with pH, time, temperature and the amount of organic matter present. 

A level of 10 ppm chlorine has been suggested as providing the highest production of THM and 

that levels above 1 ppm/THM can produce unacceptable levels. 

It is indicated that there may be a need to ventilate hydrogen generated during the electrolytic 

generation in order to prevent accumulation. 

It is also stated that free chlorine gas was generated during the process. 

As both hydrogen and chlorine gas are explosive, and as THM is a carcinogenic, it should be 

confirmed that residual levels of these substances within the ballast tanks following the treatment 

process remain within acceptable limits for crew and ship safety. Monitoring of levels of these 

substances and additional appropriate safety procedures should be required for the opening of 

treated ballast tanks and personnel tank entry until it has been verified that such precautions are 

unnecessary. 

The submission informs that tests with chlorine solutions have previously resulted in an 

increased degradation effect on tank coatings together with increased corrosion. This may be 

especially relevant for ballast piping after the treatment unit as additional turbidity caused by gas 

generation may be anticipated. 

No data of the corrosivity of treated ballast water was provided in the dossier. However, other 

reports available for the Group indicate an increase of approximately 100% of normal corrosion 

rates in the lower sections of ballast tanks. The initial concentration of TRC in these studies were 

reported to be around 5 mg TRC/L, while the initial studies in the ECS is given to be between 20 

and 30 mg TRC/L. The applicant therefore should provide corrosion studies going over at least 

six months. 
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6 Environmental fate and exposure 

6.1 Fate and behaviour properties 

Property Cl2 HO⋅ HOCl 

Hydrolysis 

pH4 Dissociation NA Unstable 

pH7 Dissociation NA Unstable 

pH9 Dissociation NA Unstable 

Photolysis Very quick NA Very quick 

Degradation in seawater Dissociation NA Unstable 

Ready biodegradation NA NA NA 

Biodegradation NA NA NA 

Sorption NA NA NA 

Bioconcentration NA NA NA 

Anaerobic degradation NA NA NA 

NA = not applicable 

6.2 Fate in ballast water tanks 

Considerations: 

• As stated in the application dossier the formation of the Active Substance is described 

with the following reaction equations: 

Cl2 + H2O HCl + HOCl 

HOCl H+ + OClñ

where HOCl and OClñ

 are considered the real actives. 

• The amount of chloride ions present in seawater is about 19.5 g Clñ/L. 

• In seawater also bromine is a natural constituent amounting about 0.068 mg Brñ

/L. 

• At normal pH-values in seawater OClñ

 will react with bromine to HOBr which is even 

more reactive than HOCl. 

• Both substances may oxidise organic compounds present in seawater which 

subsequently are degraded to finally H2O and CO2. 

• In the literature it is known that amongst these oxidation products also 

trihalomethanes, halophenols, and chlorinated acetic acids are formed. 

• Another concern was the release of metals from the oxidised material. 

Research into the above areas showed generally no increase to higher levels than the detection 

limits of the chemicals of concern. Concentrations determined stayed generally well below the 

limit of detection. 

Some experiments determined the half life of total residual chlorine (TRC). TRC is defined as the 

amount of chlorine still active. It was found that there is a significant difference in the TRC 

levels after exposure in light or dark conditions. Generally, under light conditions the TRC-levels 

decreased to low levels (>90% decrease) but under dark conditions a much lower decrease was 

found especially within the first couple of days. After this time often a quick decrease followed, 

but levels stayed at much higher levels than under light conditions. Levels up to 30% of initial 
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concentration and in one case up to about 60% of the initial level was still present. In such cases 

dechlorination with e.g. sodium bisulfite was recommended. 

Therefore, TRC levels up to 20 mg/L may be expected in certain circumstances based on 

normally generated rates of HOCl (30 mg/L). Such levels exceed to a great extent the USEPAstandard of 0.013 mg/L for effluents. 

6.3 Fate in the environment 

After discharge of the ballast water the amount of TRC will be reduced very quickly because of 

the changed light conditions; although the turbidity of the receiving waters will limit the decay. 

6.4 PEC calculation 

The document MEPC 54/2/3 in item 5.4 presents information about the effect of TRC discharged 

to sea water. PEC is presented for a scenario simulating discharge of ballast water treated by the 

system at the Rotterdam harbour. It was considered that the total residual chlorine (TRC) at 

discharge, proposed in Doc. MEPC54/2/3, was too high because this number was estimated to be 

the concentration at the exit of the system. We can expect that some degradation of TRC in 

ballast tanks along the time. The Group also calculated a PEC for a TRC concentration of 5 mg/l 

in the discharged water for a more realistc scenario using the same dilution ratio (about 2140 ×). 

7 Environmental hazards 

7.1 Active substance and preparation 

The active substances from the Electro-Clean treatment system are stated to be: 

• Cl2 (Chlorine) 

• HOCl (Hydrogen hypochlorite) 

• OClñ

 (hypochlorite ion) 

• OH· (hydroxyl free radicals) 

Remarks:

• High concentrations (20 ñ 30 mg/L) of the above mentioned active substances will 

quickly react with other substances in the seawater and the active substances will be an 

equilibrium mixture of hypochlorous acid (HOCl), hypochlorite ions (OClñ

), 

hypobromous acid (HOBr), hypobromite ions (OBrñ

) and others. These are often referred 

to as chlorine produced oxidants (CPO) in seawater or total residual oxidants (TRO) in 

freshwater and refer to the sum of all oxidant compounds produced. Data for bromide 

compounds are not presented or discussed in the dossiers. By the presence of bromide in 

sea water during the electrolytic process, bromine and consequently hypobromous acid 

and hypobromite will be also produced and no consideration was given about these 

actives substances in this assessment. 

• There is little information about the active substances formed when electrolysing 

freshwater. 

7.2 Aquatic toxicity data 

Remarks: 

1. In the dossiers some data have been indicated as chronic. According to the Group 

these should be considered as acute toxicity data. 
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2. The test data claimed to present acute toxicity with 30 and 60 minutes exposure. 

They should be considered as not relevant for assessing environmental hazards and 

they are therefore not used in this assessment. 

3. Short term and long-term aquatic toxicity test data are available for all these 

compounds in open literature data-sets with a range of marine and freshwater species. 

To some extent the Group has compiled such data for this assessment. 

Chlorine 

Aquatic toxicity data of chlorine with some species are presented in the table below: 

Taxonomic group Species Endpoint Result Reference 

Invertebrate Keratella 

cochearis 

Mortality 4 h TL50: 0.019 

mg/l 

Fresh Water Fish Salmo gardnerii Mortality 168 h LC50 = 

0.08 mg/l 

Hypochlorite ion/Hydrogen hypochlorite 

Aquatic toxicity data of hypochlorite with key species are presented in the table below: 

Taxonomic 

group 

Species Endpoint Result Reference 

Algae Thalassiosira 

guilardii 

Growth 

inhibition 

EC50 (24h): 

0.075 mg/L 

IUCLID 

Crustaceans Ceriodaphnia sp. Mortality LC50 (24h): 

0.006 mg/L 

IUCLID 

Fish Clupea harengus Mortality LC50 (96h): 

0.033-0.097 

mg/L 

IUCLID 

Oncorhyncus 

gorbuscha 

Mortality LC50 (96h): 

0.023-0.052 

mg/L 

IUCLID 

• Estimated NOEC from acute results from Daphnia neonate individuals = 0.031 mg/l 

• NOEC for Mysid (opossum shrimp) = 0.087 mg/l 

Free hydroxyl radicals 

This compound is extremely short lived in the ballast tanks and will probably not be discharged 

to the environment. Acute toxicity data are therefore not presented. 

7.3 Conclusion and recommendation 

Should be pointed out that due to the presence of bromide in the sea during the electrolitic 

process bromine and consequently hypobromous acid and hypobromite will also be produced and 

no consideration about these active substances is contained in this assessment. 
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8 Environmental risks 

8.1 PBT assessment 

The following properties of the components of ELECTRO CLEAN are found: 

Compound Persistence Bioaccumulation Toxicity 

Chlorine 

Hypochlorite NOEC: 31 μg/L 

Free hydroxyl radical Very quickly 

degradable 

 

None of the substances identified in the application dossier as being generated in the 

electrolytical process fulfil the criteria for PBT substances. Other substances that might be 

generated during and after the process may possess PBT properties, but it has not been possible 

to consider this in the current evaluation due to lack of information. 

8.2 Toxicity of treated water when discharged 

Remarks: 

• Some of the data provided in the three dossiers regarding possible concentrations of 

active substances in the discharged treated ballast water seem to be contradictory to the 

conclusions in the application (MEPC 54/2/3). This is in particular the case for the decay 

rates presented for TRC where several studies indicate that TRC may be higher than 8 

mg/L after 1 ñ 2 days (or more), while the application states (MEPC 54/2/3 p. 21) that the 

TRC in the discharge will be ìless than a few mg/Lî and on p.24 section 7.2.5 the halflife 

under dark condition is 2 days. According to the BMT study provided in the dossier 

(Book 3) the resulting biological efficacy of 8-9 mg TRC/L is high (approx. 96%). From 

this it may be concluded that the acute toxicity may be high when treated ballast water is 

discharged. 

• In the dossiers and MEPC 54/2/3 there are several references to permitted effluent limits 

of TRC. According to USEPA 1999 the CMC (Criteria Maximum Concentration) is 13 

μg/L of chlorine (as free chlorine). This value is also used as limit for CPO in effluent 

water to enclosed bays and estuaries in the 2005 Draft from California Environmental 

Protection Agency (1 hour average concentration), the 4 day maximum average 

concentration is given to be 7.5 μg/L. 

• Dilution calculations are copied from the German application and contain even less 

background information about the basic assumptions on the scenario and the input data 

for the calculations than the original. These dilution calculations are therefore of little 

value for this assessment. 

• Data from several studies presented in the dossiers are not used in the application 

(MEPC 54/2/3) 

• The retention time of treated water before testing the aquatic toxicity of the dilution series 

is not given, but the Group assumes this to be immediately after treatment. 

The aquatic toxicity of treated ballast water is tested in a dilution series presented in pages 80-81 

in Technical Add Documents (Book 3). There was no information about the concentration of 

TRC in the tested water. Dilutions of the treated ballast water vary between 1:1 and 1:250. 

Results may be calculated as an indication of LC50 for the treated ballast water, which results in 

the following approximate values of LC50: 

- Algae: < 0.4 ñ 2% 

- Ciliates: 5 ñ 10 % 

- Copepods (Acartia): 40 % 

- Fish: 10 ñ 20% 
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Based on these estimates, the Group concludes that a dilution of around 100 times is necessary 

for avoiding acute toxic effects of the treated ballast water. 

Therefore, considering the degradation of the TRC presented in the dossiers and the toxicity 

values above, acute impacts to the aquatic biota may be expected in the surrounding area of the 

discharge. 

8.3 PEC/PNEC 

The reported NOEC for calculation of the PEC/PNEC ratio was considered. The NOEC from 

chronic toxicity results available for hypochlorite for daphnia provided from the dossier was used 

and it was also assumed that the TRC was referred to hypochlorite. The PEC/PNEC for the TRC 

of 5 mg/l was calculated for daphnia. [I donít understand this sentence? In my view, it could go 

out.] The lowest acute toxicity data available for other organisms was used. The table below 

presents the values of PEC/PNEC. 

PEC/PNEC for NaOCl discharged 

Source PEC 

(μg/l) 

NOEC 

(μg/l) 

Assessment 

factor 

PNEC(μg/l) PEC/PNEC 

Dossier & Doc. 10 3.1 4.52 

MEPC 54/2/3 14 31 100 0.31 45.2 

Dossier & Doc. 10 8.7 1.61 

MEPC 54/2/3 14 87 100 0.87 16.1 

Calculated 2.33 31 10 3.1 0.75 

100 0.31 7.52 

Calculated 2.33 6 10 0.6 3.8 

100 0.06 38 

In general, the PEC/PNEC is higher than 1 for the majority of the cases. The results suggest that 

there is a possibility of long term effects in a receiving environment by the continuous discharge 

of the water treated by the system. 

9 Conclusions and recommendations 

9.1 The active substances produced by the system appear to produce short term impacts and 

potential long term impacts to the receiving environment. 

9.2. The Group considered that human exposure to the active substances generated by ECS is 

most probably associated to acute health effects (irritation to skin and respiratory tract) therefore 

recommended as mandatory the application RMM (risk management measures) for the protection 

of the exposed populations to the main routes of concern: dermal and inhalation. In addition, and 

taking into account the actual scientific knowledge, the adverse health effects associated to 

chlorinated by-products exposure should be further investigated, mostly on the long term 

scenarios. 

9.3 Mitigation procedures or operations should be established to reduce the TRC to levels 

that avoid risk to the environment in the case of short trips and during the treatment of fresh 

waters. 
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9.4 It seems that the application of the ECS leads to creation of substantial amounts of very 

reactive species, in particular chlorine solutions that may lead to increased corrosion of the tank 

and piping. The potential damage to the ship has not been elucidated. 

• The amounts of total residual chlorine (TRC) formed during the electrolytic process 

result in concentrations in the treated ballast water that largely exceed limit values 

established for discharge of waste water from land-based point sources. The 

degradation rate of TRC is so low that substantial concentrations may be expected 

also at discharge of treated ballast water. In addition, the potential health risks have 

not been sufficiently characterised. 

• Acute aquatic toxicity tests have been conducted with sea water to different species 

immediately after treatment with ECS. The tests showed that a dilution of up to more 

than 100 times is required before acute toxicity can be avoided. 

• The assessment of environmental exposure concentrations have apparently been based 

directly on the same model calculations with the MAMPEC model as presented in the 

application dossier submitted by a separate applicant. The Group would require access 

to the input data and more information on the parameters within the model in order to 

ascertain the vailidity of the results. 

• Finally, an aquatic risk assessment based on the measured concentrations in treated 

ballast water, the dilution model assuming a dilution of approximately 2,000 times 

and derived Predicted No-Effect-Concentrations for hypochlorite showed an 

estimated risk to the aquatic environment. 

• The dossier does not include documentation of which actives are produced in fresh 

water application. A full documentation of their properties should be included. 

• The application dossier does not include documentation of the quality control/quality 

assurance programme as requested in G9: 4.2.4. 

9.5 After considering all of the above concerns, it is the opinion of the Group that the 

proposal has not demonstrated whether there is a potential for unreasonable risk for environment, 

human health, property and resources. The Group therefore considers it appropriate that further 

land-based studies be conducted before on board testing eventually takes place. Consequently, 

the Group recommends that the Organization should grant a basic approval to the proposed 

Electro Clean System with conditions that land-based testing address the concerns for short- and 

long-term impacts to the receiving waters before an eventual on-board testing is approved. 

***

MEPC 54/2/12 

I:\MEPC\54\2-12.doc 

ANNEX 2 

TIME SCHEDULE FOR REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST 

WATER MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES 

BY THE GESAMP-BWWG 

Deadline Action by submitting Member Time 

allocation 

Activities to be undertaken by 

the Secretariat 

28 weeks • provide the Letter of 

Agreement 

• transfer the necessary 

fees 

• submit the 

comprehensive 

proposals for approval 

 (dossiers) 

• submit the 

non-confidential 

document to MEPC∗

8 weeks • recruitment of consultant 

• contracting and travel 

arrangements for the 

members of the Group 

• verification of the 

dossiers 

• correspondence with the 

submitting members for 

completion of dossiers if 

required 

• consolidation of the 

additional relevant 

information received from 

interested parties 

20 weeks n/a 1 week • facilitate the meeting of 

the GESAMP-BWWG 

19 weeks n/a 1 week • assist consultant to 

finalise the report and 

circulate the final draft to 

GESAMP 

18 weeks • Confirm their 

acceptance for the 

distribution of the report 

after checking that no 

confidential data is 

contained 

4 weeks • coordinate GESAMP 

review and approval of 

the report 

14 weeks n/a 1 week • consolidate the final 

report and prepare the 

submission to MEPC 

13 weeks n/a 13 weeks • Documents Section 

processes, translates and 

distributes the report as an 

MEPC document 

 week of 

MEPC 

n/a 1 week • Committee takes into 

account the report of the 

GESAMP-BWWG when 

deciding on Basic 

Approval 

_____________

 

∗

 Members are kindly request to submit the non-confidential data to the session of the MEPC before the one 

expected to decide or at their earliest opportunity after, but not after 28 week deadline indicated in the above.