I:\MEPC\56\2-2.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 

56th session 

Agenda item 2 

MEPC 56/2/2

 13 April 2007

 Original: ENGLISH

HARMFUL AQUATIC ORGANISMS IN BALLAST WATER 

Report of the third meeting of the GESAMP-Ballast Water Working Group 

(GESAMP-BWWG) 

Note by the Secretariat 

SUMMARY

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

GESAMP Ballast Water Working Group (GESAMP-BWWG) and 

includes the evaluation of proposals submitted for approval by 

Norway, the Republic of Korea, Japan and Sweden 

Action to be taken: Paragraph 4 

Related document: GESAMP-BWWG 3/9 (attached) 

Introduction

1 The third meeting of the GESAMP-BWWG was held at IMOís temporary headquarters 

from 19 to 24 February 2007, the report, of which, is attached to this document with the symbol 

GESAMP-BWWG 3/9. 

2 The prime purpose of this meeting was to review the proposals for the approval of Ballast 

Water Management Systems that use Active Substances to treat ballast water prior to discharge 

into the marine environment. The reviews of those proposals considered by the Group are shown 

in annexes 5, 6 and 7 of the attached report. 

3 As instructed by the Committee, the Group also continued to develop the Draft 

Methodology for Information Gathering and the Conduct of Work of the GESAMP-BWWG (the 

Methodology). 

Action requested of the Committee

4 The Committee is invited to (paragraphs referred to are those of GESAMP-BWWG 3/9): 

 .1 agree that the definition of Relevant Chemicals in G9 be interpreted as shown in 

paragraph 1.1.6 of the Methodology (paragraphs 3.2.1 and 3.2.2); 
MEPC 56/2/2 - 2 - 

I:\MEPC\56\2-2.doc 

 .2 agree that all chemicals which might be produced by a ballast water management 

system be identified to the Group with a scientific justification for those 

considered not to be Relevant Chemicals (paragraphs 3.3.1 to 3.3.5); 

 .3 agree that the existing IMO Conventions and Codes might serve as a basis for 

ensuring that the handling and stowage of chemicals used to treat ballast water can 

be done safely and instruct the appropriate IMO body to develop the appropriate 

criteria (paragraphs 3.4.3 to 3.4.5); 

 .4 agree that the Methodology is a living document in need of further development 

but that it is currently suitable as a guidance document for applicants submitting 

requests for evaluation of ballast water treatment systems to the Group 

(paragraphs 5.1.4 to 5.1.6); 

 .5 endorse the Groupís proposal for the need to have Human Exposure Scenario 

(HES) as part of the Risk Assessment procedure for ballast water management 

systems (paragraphs 5.2.4 and annex 9); 

 .6 endorse the requirement for a suitable Emission Scenario Document (ESD) and 

take action to evaluate the suitability of existing models and develop a new model 

specifically designed for this task if deemed necessary; (paragraphs 5.3.2 

to 5.3.8); 

 .7 agree with the Groupís interpretation of G8 and G9 for obtaining a Type Approval 

Certificate (paragraph 5.4.3); 

 .8 endorse the view that, for Final Approval, toxicity testing should be done on two 

types of seawater at two appropriate time intervals after treatment 

(paragraph 5.4.9); 

 .9 agree that information on Total Residual Oxidants (TRO) and Total Residual 

Chlorine (TRC) produced by some system should be given to the Group as part of 

the application for evaluation (paragraph 5.5.2); 

 .10 agree that the toxicity testing identified by the Group in the evaluation for Basic 

Approval would need to be given to the Group for consideration as part of the 

Final Approval process (paragraph 5.5.5); 

 .11 agree that, in order to make a meaningful recommendation to the Committee, the 

Group has to do so for the proposed system in conjunction with the chemicals 

used or produced and it is not possible to limit the evaluation to the Active 

Substance(s) alone (paragraph 6.1.4); 

 .12 agree that both Basic Approval and Final Approval be granted to the PureBallast 

System reported by Sweden and Norway in MEPC 55/2/5 and MEPC 56/2/1 

(paragraph 6.4.2.1); 

 .13 agree that Basic Approval be granted for the NKO Ballast Water Treatment 

System (NKO BWTS) reported by the Republic of Korea in MEPC 55/2/3 

(paragraph 6.4.2.2); 
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I:\MEPC\56\2-2.doc 

 .14 agree that Basic Approval should NOT be granted to the Hybrid Ballast Water 

Treatment System reported by Japan in MEPC 56/2 (paragraph 6.4.2.3); and 

 .15 agree to the report in general. 

***

I:\MEPC\56\2-2.doc 

GESAMP-BWWG 

3rd session 

Agenda item 9 

GESAMP-BWWG 3/9

 1 March 2007

 Original: ENGLISH

REPORT OF THE THIRD MEETING OF THE GESAMP-BALLAST WATER 

WORKING GROUP (GESAMP-BWWG) 

Table of Contents 

Section Page Nos. 

 

1 INTRODUCTION ÖÖ..ÖÖÖÖÖ.............................................. 3 

2 ISSUES OF CONFIDENTIALITY Ö..ÖÖÖÖÖÖ.................... 3 

3 OUTCOME OF MEPC 55ÖÖ..ÖÖÖÖÖÖÖÖÖ................... 4 

4 TERMS OF REFERENCE AND TIME FRAME ............................. 6 

5 DEVELOPMENT OF THE DRAFT METHODOLOGY FOR 

INFORMATION GATHERING AND THE CONDUCT OF 

WORK (ëTHE METHODOLOGYí) ................................................. 6 

6 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST 

WATER MANAGEMENT SYSTEMS ............................................ 11 

7 CONSIDERATION OF QUERIES REGARDING THE WORK 

OF THE GESAMP-BWWG ÖÖÖÖÖÖÖÖÖ......................... 14 

8 FUTURE WORK PROGRAMME AND TENTATIVE DATE 

FOR THE NEXT MEETING ÖÖÖ..ÖÖÖÖ............................ 14 

9 CONSIDERATION AND ADOPTION OF THE REPORT ÖÖ... 15 

ANNEXES

Annex 1 List of members attending the third session of the GESAMP-BWWG 

Annex 2 Agenda for the third session of the GESAMP-BWWG 

Annex 3 Terms of reference for the GESAMP-BWWG 

Annex 4 Draft methodology for information gathering and the conduct of work of 

GESAMP-BWWG 
GESAMP-BWWG 3/9 - 2 - 

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Annex 5 Review of the PureBallast Management System, submitted by Sweden for Basic 

Approval and by Norway for Final Approval 

Annex 6 Review of the NKO Ballast Water Treatment System, submitted by the Republic 

of Korea 

Annex 7 Review of the Hybrid Ballast Water Treatment System, submitted by Japan 

Annex 8 Timetable for activities related to the 4th meeting of the GESAMP-BWWG 

Annex 9 GESAMP BWWG ñ Human Exposure Assessment 
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1 INTRODUCTION 

1.1 The third GESAMP Ballast Water Working Group (GESAMP-BWWG 3) meeting was 

held at IMO Headquarters, London, from 19 to 24 February 2007, under the chairmanship of 

Dr. Tim Bowmer. A list of members attending this meeting is shown in annex 1, and the agenda, 

as adopted by the Group, is set out in annex 2. 

1.2 The meeting was opened by Mr. Miguel Palomares, Director of Marine Environment 

Division, who informed the Group that it had been decided to hold this third regular meeting 

instead of one regular and another additional meeting, as indicated in circular BWM.2/Circ.6. He 

explained that this was mainly due to the number of proposals submitted for approval, which had 

been received by the deadlines established in the above Circular and was aiming to optimize the 

work of the Group and to ensure the most effective use of the resources available for the Groupís 

meetings. He also informed the Group that the meeting time may be extended over the weekend 

in order to accomplish the tasks assigned by MEPC 55. Mr. RenÈ Coenen, IMO Technical 

Secretary of GESAMP, reported on the contractual arrangements and invited the Group to agree 

upon criteria for identifying alternate members that could be invited to participate, should any of 

the existing members become unavailable. Mr. Dandu Pughiuc, Head of the Marine BioSafety 

Section of Marine Environment Division, briefed the Group on the outcome of MEPC 55 

regarding Ballast Water Management Systems that make use of Active Substances and the 

specific decisions concerning the work of the Group. 

2 ISSUES OF CONFIDENTIALITY

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

submitted by three members of the Organization, namely, Japan, the Republic of Korea and 

Sweden. An application for Final Approval of the system described in document MEPC 55/2/5 

(Sweden) was submitted by Norway. The Secretariat informed the Group that the 

non-confidential parts of the submissions had been circulated as MEPC documents (MEPC 56/2 

for Japan; MEPC 55/2/3, MEPC 55/2/21 and MEPC 55/2/27 for the Republic of Korea; 

MEPC 55/2/5 for Sweden; and MEPC 56/2/1 for Norway) and emphasized that members of the 

Group were requested to keep the data contained in the application dossiers confidential to 

protect the commercial interests of the manufacturers. 

2.2 While noting the agreement of MEPC 55 that all information related to safety and 

environmental protection, including physical properties, environmental fate and toxicity, should 

be treated as non-confidential, the Group noted that the details of the functioning of the Ballast 

Water Management System (BWMS) must be regarded as confidential to protect the rights of the 

manufacturer. The Group noted that the Organization, prior to submission of the Groupís 

evaluation report to the MEPC, would consult with the applicant of the proposed the Ballast 

Water Management System to ensure that the report does not contain any confidential 

information. In cases where the evaluation report contains confidential information, the 

Organization would amend it accordingly, having taken the views of the manufacturer into 

account. 

2.3 In the case of requests to IMO from a third party for more information regarding an 

application, the Group was of the view that it might be appropriate for the Organization to 

provide the name and address of the national Administration that had submitted the original 

application for approval, which could then respond, as it feels appropriate. 
GESAMP-BWWG 3/9 - 4 - 

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3 OUTCOME OF MEPC 55

3.1 General Introduction 

3.1.1 A comprehensive introduction to the outcome of MEPC 55 was provided by the 

Secretariat (document GESAMP-BWWG 3/3). Particular emphasis was placed on the decisions 

of MEPC 55 related to the Draft Methodology for information gathering and method of work of 

the GESAMP-BWWG and the Group was requested to: 

.1 complete the development of its ëMethodology for information gathering and the 

conduct of workí taking into account comments made by various delegations in 

plenary, and in particular, paragraphs 2.26.2, 2.26.4 and 2.26.8 of the Report of 

MEPC 55 (document MEPC 55/23); 

.2 consider document MEPC 55/2/29 (Norway) and make recommendations on the 

definition and scope of ìActive Substancesî as appropriate; and 

.3 provide an outline to facilitate the development of criteria, which would specify 

how chemicals used in the treatment of ballast water could be handled and stored 

on board ship. 

3.1.2 The Group noted that MEPC 55 had considered all of the issues, from the second session 

of the GESAMP-BWWG, which had been raised under paragraph 4 of MEPC 55/2/16. 

3.1.3 Whilst noting that some concerns had been raised about specific issues, the Group 

expressed its appreciation that MEPC had generally agreed with the significant recommendations 

put to it. 

3.2 Consideration of MEPC 55/2/29 (Norway) 

3.2.1 As requested by MEPC, the Group considered the point, made by Norway in document 

MEPC 55/2/29, that the proposal to add the terms Active Substances, Preparations, Other 

components of a preparation and Relevant Chemicals ìdeviates from the Procedure for Approval 

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

considered this concern, the Group made the following points. 

 .1 the definition of Active Substance in the draft Methodology is exactly the same as 

that of G9; 

 .2 it was recognized that the definition of Preparation in the draft Methodology was 

an abbreviated version of that in G9 and agreed that it would be amended in 

accordance with that of G9; 

 .3 it was recognized that the definition of Relevant Chemical deviates from that of 

G9. However, it was considered important to include a reference to shipís safety 

and to include chemicals of concern that might be produced after the treatment 

process as chemical changes could still be taking place. It was also considered 

necessary to change the word and to and/or in reference to human health; and 

 .4 it was considered extremely important to add a reference for Other Chemicals as 

the Group considered that it needs to be aware of all chemicals that may be 
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produced by the treatment in order to ascertain which ones need to be properly 

evaluated. 

3.2.2 The Group requested MEPC to agree that these were important issues to clarify if the 

GESAMP-BWWG is to provide meaningful recommendations to the Committee in relation to the 

approval of the systems used to treat ballast water. 

3.3 Consideration of short-lived and naturally occurring by-products produced by 

ballast water treatment 

3.3.1 The Group noted that ìA significant number of delegations supported the view that 

by-products created during the ballast water treatment comparable to those occurring naturally 

and which, due to their short period of existence, do not have harmful effects after discharge 

should not be regarded as Active Substancesî. 

3.3.2 However, it was agreed that all chemicals produced by a given system should be 

identified. Having considered regulation D-3.2 of the Convention and Procedure (G9), the Group 

could not see any conflict with the request to identify all chemicals that are either present in the 

Preparation or produced during the treatment of the seawater; 

3.3.3 However, the Group recognized that some systems may produce chemicals that also 

occur naturally in the environment and it was important to be able to make a comparison of the 

levels of such chemicals produced with those occurring naturally. However, the Group was of 

the view that, where comparable levels are to be referred to, these should be supported with 

numerical values measured to the same level of sensitivity that is able to measure background 

concentrations as well. It was also noted that other chemicals produced may have such short 

half-lives that they do not pose a hazard by the time they are released into the environment. 

3.3.4 As a result, the Group recommended that such chemicals, generated by a system, should 

be identified with a technical explanation of why they need not be evaluated in detail, regardless 

of whether they are short-lived or naturally occurring. Without such information, it is not 

possible for the Group to provide a full and meaningful recommendation to MEPC on the risks 

associated with a particular system. 

3.3.5 In this context, the Group considered that any system that alters the chemical composition 

of seawater should be evaluated by the Group prior to MEPC considering the granting of Final 

Approval. 

3.3.6 The Group requested MEPC to agree with this approach. 

3.4 Storage and handling of chemicals used to treat ballast water

3.4.1 The Group recalled that it had requested MEPC to consider developing criteria that would 

specify how chemicals used to treat ballast water should be handled and stored onboard. It was 

noted that MEPC 55 had then referred the question back to the Group to develop an outline of 

how this might be done. 

3.4.2 However, the Group considered that, as IMO had various existing conventions and codes 

addressing this issue, it was not in a position to make alternative proposals that it considered 

were outside its expertise. 
GESAMP-BWWG 3/9 - 6 - 

I:\MEPC\56\2-2.doc 

3.4.3 Notwithstanding this point of view, the Group agreed that such IMO codes, such as IBC, 

IMDG and IGC etc, could be considered as a basis for defining the storage requirements of such 

chemicals and that additional information provided by the required MSDSs and product labelling 

could be employed in the development of handling requirements. 

3.4.4 In this context, the Group suggested that special consideration might also be given to the 

appropriateness of using of certain chemicals on passenger ships as well as the need for giving 

specific training to crews in their handling and emergency situations appropriate to the nature of 

chemicals being employed and the responsibility of the individuals involved. 

3.4.5 Furthermore, the importance of developing human exposure scenarios and associated 

Risk Assessment Procedures was emphasized as being needed in order to assess the human risks 

involved in the handling and storage of chemicals used to treat ballast water. 

3.5 Methodology for information gathering and the conduct of work 

3.5.1 This issue is discussed under agenda item 5. 

4 TERMS OF REFERENCE AND TIME FRAME

4.1 The Group agreed to continue to be guided by the Terms of Reference approved by 

MEPC 55, as contained in annex 3 of this report, and decided to request further clarification from 

the Marine Environment Protection Committee on some of the specific tasks and in particular 

regarding the role played by the GESAMP-BWWG during the Final Approval. Detailed requests 

for clarification are included in section 5 below as they bear particular relevance to the 

Methodology of information gathering and the conduct of work. 

5 DEVELOPMENT OF THE DRAFT METHODOLOGY FOR INFORMATION 

GATHERING AND THE CONDUCT OF WORK (ëTHE METHODOLGYí)

5.1 Consideration of general points raised by MEPC related to ëthe Methodologyí 

5.1.1 The Group noted the request to complete the development of ëthe Methodologyí 

taking into account comments made by various delegations in plenary, and in particular, 

paragraphs 2.26.2, 2.26.4 and 2.26.8 of the Report of MEPC 55 (document MEPC 55/23). 

5.1.2 The Group were pleased to note that MEPC had agreed with its responses to the 

comments made in MEPC 55/2/2 and MEPC 55/2/6. However, it was agreed that in order for the 

Group to give meaningful recommendations to MEPC, the requirements made in the 

Methodology would have to be clearly defined in order to be effective. 

5.1.3 The discussion related to paragraph 2.26.8, on the consideration of all chemicals 

produced by a system, is reflected in section 3 of this report. 

5.1.4 Notwithstanding any of the discussion related to ëthe Methodologyí, the Group 

recognized that this remains a living document that will need to be changed in the light of 

experience gained during the evaluation process. 

5.1.5 In this context the Group agreed that when ëthe Methodologyí is closer to completion, it 

should be reviewed by GESAMP, from a technical point of view, and put to MEPC for 

endorsement as the method to be used in evaluating all applications. 
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I:\MEPC\56\2-2.doc 

5.1.6 However, the Group considered that the methodology, as shown in annex 4, should 

provide sufficient guidance to facilitate applications for Basic Approval that would allow proper 

evaluations of the risks associated with systems to be carried out. However, the Group also 

recognized that further work needed to be carried out as more experience is gained. 

5.2 Development of a Human Exposure Scenario (HES)

5.2.1 In considering the need for an HES, the Group agreed that in order to identify the risks 

associated with human exposure and safety of the ship, it was particularly important to: 

 .1 provide a full description of the processes and individual operations in which 

exposure may occur when using the BWMS both onboard and, where appropriate, 

loading and storing the Active Substance or Preparation onboard; 

 .2 ascertain the duration and frequency of such tasks; 

 .3 identify situations in which a reduction of amenities and interference with other 

uses of the sea might be caused by the discharge of treated ballast water into the 

sea; 

 .4 identify Personal Protective Equipment (PPE) and control measures to be used in 

order to reduce and mitigate exposure; and 

 .5 ascertain the potential of the system to cause damage to the ship or its equipment. 

5.2.2 It was recognized that it is not sufficient to just evaluate the hazards associated with the 

treated ballast water and that this approach only allows a qualitative risk assessment to be carried 

out. Whilst recognizing that Procedure (G9) only demands a qualitative approach, the Group 

considered that this would nearly always result in a worst case approach and would not 

necessarily allow meaningful recommendations to be made to MEPC in a consistent manner. For 

example, although the use of PPE can always be considered, this might end up as an 

indiscriminate recommendation that would, erroneously, suggest no risk and so remove the 

necessity to conduct further refinement of the risk assessment. 

5.2.3 In recognizing these requirements, the Group agreed on the above approach that would 

need to be taken to develop a quantitative risk assessment with respect to human health and ship 

safety. 

5.2.4 Having agreed on these points, the Group developed and approach to HES as shown in 

annex 9 and requested MEPC to endorse it. 

5.3 Development of an Emission Scenario Document (ESD) 

5.3.1 The Group noted that there are a number of potentially useful models available including 

USES 4.0, EUSES 2.0, REMA, MAM-PEC, CHEMMAP, EXAMS. However, the Group did not 

have an overview of the quality and possibilities of these models. 

5.3.2 As a result, the Group recommended that, as part of the development of an ESD, a 

detailed comparison of these, and other models should be made to see if they are suitable or 

could be adapted for this purpose. It was agreed that the outcome of such a comparison could be 

used to recommend a model for use in the further evaluation of BWMS. 
GESAMP-BWWG 3/9 - 8 - 

I:\MEPC\56\2-2.doc 

5.3.3 It was also agreed that any recommended model should then be made available to the 

Group for its own application during the evaluation process. 

5.3.4 In considering the sort of scenario to be run by such a model, the Group agreed that a 

rather simplified emission scenario would define the receiving water compartment with the 

discharge events, e.g. the volume of the receiving water, the number of ships discharging ballast 

water, the amount of discharged volume, the potential tidal exchange factor. 

5.3.5 It was also agreed that more advanced models might also be very useful and that such 

models might need more data such as volatilization and photolytic degradation in order to obtain 

a more realistic and state-of-the-art calculation of Predicted Environmental Concentrations 

(PECs). 

5.3.6 In making these observations, the Group recognized that all such substance related data 

are already included in the dossier, including the identity of the discharged chemicals and their 

physico/chemical data, sorption characteristics and degradation rates. 

5.3.7 In this context, the Group welcomed the submission, by the UK to BLG (BLG 11/4/11) 

that made suggestions for a possible outline of a specific ESD tailored to a specific treatment that 

could be used in the process of Final Approval. It was recognized that this would be a very 

useful basis for further discussion and development of the subject. The Group expressed its 

appreciation of the paper submitted by the UK and hoped that the above views, relating to the 

use/development of a suitable ESD could be taken into account when the subject is discussed at 

IMO meetings. 

5.3.8 Whilst recognizing the various difficulties in developing any such model, the Group 

agreed that, in order to provide MEPC with meaningful and consistent recommendations a 

standardized system should be developed for use by all applicants providing PECs after a 

specified period following the discharge of ballast water into the environment. 

5.4 Consideration of the requirements for Basic Approval and Final Approval

5.4.1 Recognizing that an application had been made for both Basic Approval and Final 

Approval of a system, the Group considered that it was important to note the requirements 

identified in G8 and G9 for both processes. As a result, it was noted that: 

 .1 ìfor the Basic Approval Process, discharge testing should be performed in a 

laboratory using techniques and equipment to simulate ballast water discharge 

following treatment by the Preparationî, whilst, 

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

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

Ref: G9, paragraph 5.2.1 

5.4.2 Furthermore, the Group noted that Basic Approval involves: 

 .1 the generation of data by the manufacturer; 

 .2 endorsement by the Administration; 

 
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.3 evaluation by the Group; and 

 .4 approval by MEPC. 

5.4.3 In order to obtain Final Approval, the Group noted that, in accordance with 

paragraph 8.2 of Procedure (G9): 

 .1 Basic Approval has to be given first; 

 .2 ìthe Member of the Organization, submitting an application should conduct the 

Type Approval tests in accordance with Guidelines for Approval of Ballast Water 

Management Systems (G8)î. 

 .2.1 In considering this point, the Group noted that Guidelines (G8) is concerned with 

efficacy testing but paragraph 1.6.4 of part 1 of the annex, states: 

 ìPotential hazards for the environment should be identified and documented based 

on environmental studies performed to the extent necessary to assure that no 

harmful effects are to be expected. In the case of Ballast Water Management 

Systems that make use of Active Substances or Preparations containing one or 

more Active Substances the procedure described in the Procedure for the 

Approval of Ballast Water Management Systems that make use of Active 

Substances should be followed. The equipment must then ensure that dosage of 

the Active Substance and the maximum allowable discharge concentration are 

kept under the approved criteria at all times.î 

 .2.2 It was understood that this was a reference to G9, which describes the evaluations 

carried out by the Group and that provides a link between the two guidelines. 

 .2.3 The Group considered that the procedural details of the process for obtaining Final 

Approval were not really clear. However, it was understood that the test results 

from both Guidelines (G8) and (G9) would be used by MEPC to grant Final 

Approval and that this would then allow the Administration to issue a Type 

Approval Certificate as shown in the appendix to Guidelines (G8). 

 .2.4 In this context, the Group recognized that Type Approval of any equipment used 

onboard ship is given when the relevant body is satisfied that the Quality 

Assurance programme employed by the manufacturer will ensure that the 

equipment can be produced consistently to the required specification. 

 .2.5 It was, also, understood that before Type Approval of any Ballast Water 

Management System is granted, the risks to the ship and crew have been 

adequately addressed. 

 .2.6 the Group noted that, for Final Approval to be granted, apart from any other 

requirement required for Type Approval, the full scale land based tests, using the 

system in the same way that fulfilled the efficacy requirements, would need to 

show that the residual toxicity of the treated ballast water is no worse than the 

results obtained for Basic Approval. 
GESAMP-BWWG 3/9 - 10 - 

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5.4.4 Notwithstanding the above understanding of the processes involved, the Group had the 

following concerns. 

5.4.5 It was noted that under Guidelines (G8), efficacy testing for Final Approval is required 

for two of the three identified water types (fresh, brackish and sea). However, the full-scale land 

based toxicity testing, stipulated under G9, only requires testing of one water-type. 

5.4.6 However, the Group considered that, if efficacy testing was required for two types of 

water then toxicity testing should be dealt with in a similar manner. It was thought that this was 

particularly important because the various amounts of Dissolved Organic Carbon (DOC) and 

Total Suspended Solids (TSS) could have a marked effect on the quantities of by products 

produced by the treatment process that, in turn, would affect the toxicity of the treated ballast 

water. 

5.4.7 In this context, the Group also considered that the time-period between treatment and 

testing could also affect the toxicity of the treated ballast water and so consideration should be 

given to testing such water at two time intervals, i.e. shortly after treatment, reflecting the 

minimum permitted discharge time, and following an appropriate longer interval. 

5.4.8 Furthermore, it was agreed that organisms normally found in the selected types of 

seawater should be used in the toxicity testing. 

5.4.9 As a result, MEPC was requested to endorse the view that for Final Approval, toxicity 

testing should be done on two types of seawater at two appropriate time intervals, after treatment, 

and that this should be reflected in the Methodology. 

5.5 Further requirements for Final Approval 

5.5.1 In addition to these proposals, the Group recognized that the concentrations of Total 

Residual Oxidants (TRO) and Total Residual Chlorine (TRC) produced, by those systems that 

create such by-products, could also vary with differing types of seawater. Furthermore, the 

specific chemicals covered by such group descriptions could also vary in quality and quantity. 

5.5.2 As a result, MEPC was requested to agree that all information related to TROs, TRCs and 

the chemicals included in such groupings should be provided to the Group for Final Approval 

when requested as part of its evaluation for Basic Approval. 

5.5.3 Furthermore, in considering paragraphs 5.2.2 to 5.2.7 and, in particular 5.2.5 of 

Procedure (G9), the Group considered that there was no sense in establishing a NOEC for 

short-term toxicity testing and therefore recommended that this requirement is removed. 

5.5.4 The Group agreed that for Basic Approval the basic data set identified in the 

Methodology is needed for the treated ballast water and the individual chemicals produced by the 

system. In addition a generated meaningful PEC/PNEC ratio would be required. 

5.5.5 It was emphasized that the application for Final Approval should reflect the concerns 

identified during consideration of Basic Approval. This would mean that in some cases only 

acute toxicity testing would be needed for Final Approval and in some cases chronic toxicity 

might be needed whilst in others both acute and chronic data might be required. 

5.5.6 This would allow the Group to consider the quality of the data presented that would be 

reflected by the assessment factor used to generate the appropriate risk assessment. 
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I:\MEPC\56\2-2.doc 

5.6 Other specific issues related to the methodology

5.6.1 In considering ëthe Methodologyí, the Group agreed that: 

 .1 further guidance needs to be added in order to explain the requirements for Final 

Approval; 

 .1.1 in this context, it was noted that toxicity testing for Final Approval is, currently, 

allowed to be carried out using full-scale land based tests. However, it was also 

noted that efficacy testing demanded two seawater types and onboard testing. As 

a result, the Group considered that this approach would also be appropriate for 

toxicity testing. 

 .2 further guidance should be given to the methods used for reporting the 

concentrations of Total Residual Oxidants (TROs) and Total Residual Chlorine 

(TRCs); 

 .3 various editorial changes were required in paragraphs 3.0.4, 3.2.4, 3.3.0.1, 6.1.4 

and 7.2.1 of ëthe Methodologyí. 

6 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER 

MANAGEMENT SYSTEMS

6.1 Concerns with the approach 

6.1.1 Prior to considering the specific applications, the Group noted that the objective of the 

Procedure for Approval of Ballast Water Management Systems that make use of Active 

Substances (G9) is to determine the acceptability of the Active Substances and Preparations, 

containing one or more Active Substances, and their application in Ballast Water Management 

Systems (Ref: G9, paragraph 1.3). 

6.1.2 It was also noted that the definition of Preparations includes Relevant Chemicals 

(G9, paragraph 2.1.3) and so it is the practice of the Group to evaluate the hazards and risks 

associated with all such chemicals relevant to a ballast water management system, in order to 

make a meaningful recommendation to MEPC. 

6.1.3 However, concern was expressed that G9 indicates that ìAn Active Substance or 

Preparation may be used for Prototype or Type Approval testing for the approval of different 

BWMS without going through Basic Approval againî. 

6.1.4 Such concern was based on a recognition of the fact that the quantity of each potential 

chemical by-product, created during the treatment ballast water, might vary in accordance with 

the method of application of the Active Substance and quantity used. Whilst the same 

by-products might be produced theoretically, in practice the amount produced will dictate both 

the hazard and potential risk. 

6.1.5 In addition, the safety risks associated with a particular Active Substance might be 

acceptable in a system granted Basic Approval but could be of serious concern when used in a 

different system. 
GESAMP-BWWG 3/9 - 12 - 

I:\MEPC\56\2-2.doc 

6.1.6 This led to the concern that if the Group were to recommend Basic Approval of an Active 

Substance based on a very effective delivery system, this would allow the same chemical to be 

used in an inefficient system that might produce hazardous by-products in such quantities that 

could cause adverse effects. 

6.1.7 It was, therefore, agreed that it was not possible to evaluate an Active Substance without 

taking the whole system into account. Consequently MEPC was invited to take this into account 

and agree that the Group should be charged with the evaluation of the applicantís ballast water 

treatment system rather than just the Active Substance. 

6.1.8 Furthermore, the Group requested MEPC to either agree that paragraph 8.1.2.12 of 

Procedure G9 should be interpreted as, or amended to read: 

 ìSpecific ballast water management systems employing Active Substances or 

Preparations receiving basic approval by the Organization may be used for prototype or 

type approval testing based on the guidelines developed by the Organization.î 

6.1.9 In reviewing those applications for systems that produced certain by products such as 

THMs, the Group considered that, unless it can be demonstrated that the levels of these 

compounds produced do not present an unacceptable human health risk, appropriate mitigation 

measure must be put in place to prevent human contact with the treated ballast water. Such 

measure might, for example, include the use of Personal Protective Equipment (PPE) when 

entering ballast water tanks. 

6.2 General review of the submissions

6.2.1 The Group noted that submissions had been received from the Republic of Korea (NKO3 

Ballast Water Treatment System), Sweden (PureBallast) and Japan (Hybrid Ballast Water 

Treatment System) as part of the applications for Basic Approval. 

6.2.2 In addition, it was noted that Norway had also made a submission for PureBallast as part 

of an application for Final Approval. 

6.2.3 The Group noted that the application for Basic Approval of PureBallast had been carried 

forward from the last meeting whereas the application for Final Approval had been made later to 

this session. 

6.2.4 When considering the applications from Sweden and Norway for Basic Approval and 

Final Approval of PureBallast, the Group recognized some constraints in considering both 

Applications. In an attempt to approach this in a logical manner, the Group initially considered 

the application for Basic Approval. However, in taking this approach, sufficient problems were 

identified with the Basic Approval application, taken in isolation, to cast doubts on whether a 

recommendation to approve this system could be made to MEPC. 

6.2.5 As a result, the Group then considered the data associated with both Basic Approval and 

Final Approval together whilst recognizing that, strictly speaking, Basic Approval should have 

been granted first. However, to facilitate the process, the Group considered all of the data 

submitted when making recommendations for Basic Approval and Final Approval. 

6.2.6 Having considered all of the data together the Group emphasized that it was important 

that the appropriate ecotoxicity testing should be carried out using the same treated ballast water 

types used for efficacy testing and referred to in Procedure G8. 
 - 13 - GESAMP-BWWG 3/9 

I:\MEPC\56\2-2.doc 

6.2.7 The Group noted that many of the ballast water management systems reviewed by the 

BWWG are based on the production of free radicals or production/addition of reactive chemicals 

such as chlorine, ozone or hydrogen peroxide, all of which react with seawater to produce a 

similar set of brominated reaction products, albeit in different concentrations. 

6.2.8 Furthermore, it was noted that some of these common reaction products, such as 

bromoform and bromate ions, have significant hazards to human health and the environment 

associated with them. While individual BWMS submissions have attempted to measure the 

concentrations of these reaction products at either the basic or final approval stage, or both, the 

levels of detection used (ca. 1 μg/L) generally fell short of those used in routine surface water 

monitoring (0.01-0.05 μg/L). While the Group did not feel it necessary to refuse approval to 

individual submissions on this basis, concern remains that such reaction products had not been 

considered at a satisfactory quantification level. 

6.2.9 Therefore, the Group, in considering the volumes of ballast water that might be treated by 

such systems in representative ports and harbours, felt that the cumulative production of such 

reaction products needs further examination with regards to both the potential risks to the 

environment and human health. 

6.3 General reflections on the submissions 

6.3.1 Although three applications for basic approval were reviewed, the Group noted that 

BWM systems as described in the submissions from Sweden/Norway (UV/TiO2) and the 

Republic of Korea (ozone generation) had already been installed on board ship(s) for some time 

previously. Therefore, the important safeguards, provided by the G9 Basic Approval, safety/risk 

evaluation, have been lost in these cases. In the case of the Sweden/Norway application, land 

based testing had already been carried out by the time the application for Basic Approval had 

been reviewed and any feedback from the Group regarding safety and risk concerns could not be 

implemented. 

6.3.2 The Group raised the following points of concern associated with the G9 risk assessment 

procedure: 

 .1 In the absence of an Emission Scenario Document (ESD) or Human Exposure 

Assessment applying to the shipboard environment, human health risk assessment 

can presently only be carried out at on a qualitative basis. How conservative the 

Groupís approach, therefore, needs to be in order to cover such uncertainties was 

difficult to ascertain. In many of the submissions evaluated to date, both the 

technical complexity of the BWM systems combined with sometimes vague 

descriptions of the intended method of operation did not help in this regard (some 

systems appear to be still in the conceptual or design phase). 

 .2 Cumulative risks to the environment due to the use of BWM systems in large 

ports have yet to be considered. The focus on the risks posed by individual BWM 

systems is too limited given that most of those evaluated to date for Basic 

Approval produce a similar set of reaction by-products. 

 .3 Real quality control standards on ecotoxicity and analytical chemistry of 

simulated or actual BWMS discharges were lacking in nearly all submissions. 

Frequently it was difficult to assess when and how ballast water was treated in the 

pilot/full scale systems described by a given submission, how long it was stored, 

when samples were taken and how long, after sampling, these were tested or 
GESAMP-BWWG 3/9 - 14 - 

I:\MEPC\56\2-2.doc 

analysed. This lead, in turn, to uncertainty as to the validity of the results obtained 

and had a direct impact on the reliability of human or environmental risk 

assessment described in the submissions. 

6.4 Detailed review of the submissions

6.4.1 A detailed review of the submissions can be seen in: 

 .1 Annex 5 Review of the PureBallast Management System, submitted by 

Sweden for Basic Approval and by Norway for Final Approval by 

Sweden 

 .2 Annex 6 Review of the NKO Ballast Water Treatment System, submitted by 

the Republic of Korea 

 .3 Annex 7 Review of the Hybrid Ballast Water Treatment System, submitted by 

Japan 

6.4.2 Whilst it is recommended that the summary and results and discussion of each of the 

reviews are considered in detail, the Group recommended that: 

 .1 both Basic Approval and Final Approval be granted to the PureBallast 

Management System submitted by Sweden and Norway; 

 .2 Basic Approval be granted to the NKO Ballast Water Treatment System submitted 

by the Republic of Korea; and 

 .3 the Hybrid Ballast Water Treatment System submitted by Japan is NOT granted 

Basic Approval. 

7 CONSIDERATION OF QUERIES REGARDING THE WORK OF THE 

GESAMP-BWWG

7.1 No submissions were made under this agenda item. 

8 FUTURE WORK PROGRAMME AND TENTATIVE DATE FOR THE NEXT 

MEETING

8.1 Taking into account the timeline required for the production and circulation of IMO 

documents as provided in the Guidelines on organization and method of work of the Committee 

(MSC-MEPC.1/Circ.1), the Group agreed that its next session should tentatively be scheduled 

from 29 October to 2 November 2007 to allow sufficient time for evaluation and approval by 

GESAMP and timely submission to MEPC 57. 

8.2 Based on the experience of the previous meetings and taking into account the time needed 

for proper preparation of the next meeting, the Group recommended that MEPC 56 invites 

Administrations to submit their proposals for approval of Active Substances together with related 

application dossiers by 31 August 2007 as indicated in timetable contained in annex 8. As 

previously agreed by the MEPC, non-confidential data related to the proposals for approval of 

Active Substances should be submitted to MEPC 56 or at the earliest opportunity after that, but 

not later than 31 August 2007. 
 - 15 - GESAMP-BWWG 3/9 

I:\MEPC\56\2-2.doc 

9 CONSIDERATION AND ADOPTION OF THE REPORT

9.1 A draft report of the 3rd meeting of the GESAMP-BWWG was produced 

on 24 March 2007, and, after a paragraph-by-paragraph review, the Group agreed on the final 

text and requested the Secretariat to make the necessary changes to ensure consistency with IMO 

documents format and style. 

9.2 The Chairman expressed his appreciation for the long hours and substantial efforts made 

by the members of the Group throughout the week, valued the work done by the IMO consultant 

both in preparation and during the meeting week and closed the meeting at 14.30hrs. 

***

GESAMP-BWWG 3/9 

I:\MEPC\56\2-2.doc 

ANNEX 1 

LIST OF MEMBERS ATTENDING THE 2ND SESSION 

OF THE GESAMP BALLAST WATER WORKING GROUP 

Dr. C.T. Bowmer (Chairman) 

TNO Chemistry 

Utrechtseweg 48 

PostBox 360 E-mail: tim.bowmer@tno.nl 

3700 AJ Zeist Tel: +31 30 6944645 

The Netherlands Fax: +31 30 6944099 

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 

Ms Teresa Borges 

Senior Technical Officer 

General Health Directorate 

Rua de Arroios 97 

1150-053 Lisboa E-mail: tborges@dgsaude.min-saude.pt 

Portugal Tel: +351 21 3179767 

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 
GESAMP-BWWG 3/9 

ANNEX 1 

Page 2 

I:\MEPC\56\2-2.doc 

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 

Mr. John Crayford 

2 Dunmow Hill E-mail: j.crayford@ntlworld.com 

Fleet Tel: +44 (0)1252 672245 

Hampshire 

GU51 3AN 

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 

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 

***
GESAM-BWWG 3/9 

I:\MEPC\56\2-2.doc 

ANNEX 2 

PROVISIONAL AGENDA FOR THE THIRD SESSION OF THE 

BALLAST WATER WORKING GROUP OF GESAMP 

1 Introduction 

2 Issues of confidentiality 

3 Outcome of MEPC 55 

4 Terms of reference and time frame 

5 Development of the draft Methodology for information gathering and the conduct of work 

6 Review of proposals for approval of Ballast Water Management Systems 

7 Consideration of queries regarding the work of the GESAMP- BWWG 

8 Future work programme and tentative date for the next meeting 

9 Consideration and adoption of the report 

***

GESAMP-BWWG 3/9 

I:\MEPC\56\2-2.doc 

ANNEX 3 

TERMS OF REFERENCE FOR THE TECHNICAL GROUP 

1 Consideration of development of necessary methodologies and information requirements 

in accordance with G9∗ for consideration by MEPC 56. 

2 For Basic Approval, the Group should review the comprehensive proposal submitted by 

the Member of the Organization along with any additional data submitted as well as other 

relevant information available to the Group and report to the Organization. 

 In particular, the Group should undertake: 

.1 Scientific evaluation of the data-set in the proposal for approval (see 

paragraphs 4.2, 6.1, 8.1.2.3, 8.1.2.4 of G9); 

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

approval (see paragraph 4.3.1 of G9); 

.3 Scientific evaluation of the risks to the ship and personnel to include consideration 

of the storage, handling and application of the active substance (see paragraph 6.3 

of G9); 

.4 Scientific evaluation of any further information submitted (see paragraph 8.1.2.6 

of G9); 

.5 Scientific review of the risk characterization and analysis contained in the 

proposal for approval (see paragraph 5.3 of G9); 

.6 Scientific recommendations on whether the proposal has demonstrated a potential 

for unreasonable risk to the environment, human health, property or resources 

(see paragraph 8.1.2.8 of G9); and 

.7 Preparation of a Report addressing the above-mentioned aspects for consideration 

by MEPC (see paragraph 8.1.2.10 of G9). 

3 For Final Approval, the Group should review the discharge testing (field) data and 

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

Basic Approval and that the previous evaluation of the risks to the ship and personnel including 

consideration of the storage, handling and application of the active substance remains valid. The 

evaluation will be reported to MEPC (see paragraph 8.2 of G9). 

4 The Group shall keep confidential all data, the disclosure of which would undermine 

protection of the commercial interests of the applicant, including intellectual property. 

***

 

∗

 G9 stands equivalent for MEPC 53/2/1, annex, as amended: Procedure for approval of ballast water 

management systems that make use of Active Substances (G9). 

GESAMP-BWWG 3/9 

I:\MEPC\56\2-2.doc 

ANNEX 4 

DEVELOPMENT OF A DRAFT METHODOLOGY FOR INFORMATION 

GATHERING AND THE CONDUCT OF WORK OF GESAMP-BWWG 

1 INTRODUCTION..................................................................................................................3 

1.1 Terms and Definitions...............................................................................................3 

1.2 Abbreviations used in the text ..................................................................................4 

2 GENERAL..............................................................................................................................5

2.1 Legal provision...........................................................................................................5 

2.2 Principles of acceptability of BWMS that make use of Active Substances ..........6 

2.3 Submission of an application for Basic Approval...................................................6 

2.4 Confidentiality and data protection .........................................................................7 

2.5 Test Methods ..............................................................................................................8 

2.6 Alternatives to testing and non-submission of data................................................8 

2.7 Procedures and timelines ..........................................................................................9 

3.0 DATA-SET REQUIRED IN THE APPLICATION...........................................................9 

3.1 Identification of the Substance or Preparation (G9: 4.1).......................................9 

3.1.1 Preparations ...........................................................................................................9

3.1.2 Active Substance ..................................................................................................10

3.1.3 Relevant Chemicals (G9: 2.1.4):.........................................................................10

3.1.4 Other Chemicals: .................................................................................................11

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

including sensitive and representative organisms (G9: 4.2.1.1)...........................11 

3.2.1 Acute aquatic toxicity ..........................................................................................11

3.2.2 Chronic aquatic toxicity ......................................................................................11

3.2.3 Endocrine disruption...........................................................................................12

3.2.4 Sediment toxicity..................................................................................................12

3.2.5 Bioavailability/biomagnification/bioconcentration...........................................12

3.2.6 Food web/population effects ...............................................................................13

3.3.0 Data on mammalian toxicity (G9: 4.2.1.2)............................................................13 

3.3.1 Acute toxicity........................................................................................................14

3.3.2 Effects on skin and eye ........................................................................................14

3.3.3 Repeated-dose toxicity.........................................................................................14

3.3.4 Chronic toxicity....................................................................................................15

3.3.5 Developmental and reproductive toxicity..........................................................15

3.3.6 Carcinogenicity ....................................................................................................15

3.3.7 Mutagenicity/genotoxicity ...................................................................................16

3.3.8 Toxicokinetics.......................................................................................................16

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

(G9: 4.2.1.3) ..............................................................................................................16 

3.4.1 Modes of degradation (biotic; abiotic) ...............................................................16

3.4.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient...17

3.4.3 Persistence and identification of the main metabolities in the relevant media 

(ballast water, marine and fresh waters)...........................................................18

3.4.4 Reaction with organic matter .............................................................................18

3.4.5 Potential physical effects on wildlife and benthic habitats ..............................19

3.4.6 Potential residues in seafood...............................................................................19

3.4.7 Any known interactive effects.............................................................................19

3.5 Physical and chemical properties for the Active Substances and preparations 

and treated ballast water, if applicable (G9: 4.2.1.4)...........................................20

3.5.1 Melting point ........................................................................................................20

3.5.2 Boiling point .........................................................................................................20

3.5.3 Flammability (flash point)...................................................................................20
GESAMP-BWWG 3/9 

ANNEX 4 

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I:\MEPC\56\2-2.doc 

3.5.4 Density (relative density).....................................................................................20

3.5.5 Vapour pressure, vapour density .......................................................................20

3.5.6 Water solubility/dissociation constant ...............................................................20

3.5.7 Oxidation/reduction potential.............................................................................21

3.5.8 Corrosivity to the materials or equipment of normal ship construction........21

3.5.9 Auto-ignition temperature ..................................................................................21

3.5.10 Explosive properties.............................................................................................21

3.5.11 Oxidizing properties ............................................................................................21

3.5.12 Surface tension .....................................................................................................22

3.5.13 Viscosity ................................................................................................................22

3.5.14 Thermal stability and identity of relevant breakdown products ....................22

3.5.15 Reactivity towards container material...............................................................22

3.5.16 pH ..........................................................................................................................22

3.5.17 Salinity ..................................................................................................................22

3.5.18 TOC, DOC, % particulate matter......................................................................22

3.5.19 Other known relevant physical or chemical hazards .......................................23

3.6 Analytical methods at environmentally relevant concentrations (G9: 4.2.1.5).23 

4 USE OF THE ACTIVE SUBSTANCE OR THE PREPARATION ...............................23 

4.1 The manner of application......................................................................................23 

5 MATERIAL SAFETY DATA SHEETS (G9: 4.2.7)........................................................24 

6 RISK CHARACTERIZATION..........................................................................................24 

6.1 Screening for persistence, bioaccumulation and toxicity (G9: 5.1).....................24 

6.1.1 Persistence (G9: 5.1.1.1) ......................................................................................24

6.1.2 Bioaccumulation (G9: 5.1.1.2)............................................................................25

6.1.3 Toxicity tests (G9: 5.1.2.3)...................................................................................25

6.2 Evaluation of the treated ballast water (G9: 5.2).................................................25 

6.2.1 Basic approval......................................................................................................25

6.2.2 Final approval ......................................................................................................26

6.2.3 Determination of holding time............................................................................26

6.3 Risk characterization and analysis.........................................................................26 

6.3.1 Reaction with organic matter (see G9: 4.2.1.3; this report 2.4.4)....................26

6.3.2 Characterization of degradation route and rate (G9: 5.3.5)................................26 

6.3.3 Prediction of discharge and environmental concentrations ............................26

6.3.4 Assessment of potential for bioaccumulation....................................................27

6.3.5 Effects assessment ................................................................................................27

6.3.6 Effects on aquatic organisms ..............................................................................27

6.3.7 Effects on sediment ..............................................................................................28

6.3.8 Comparison of effect assessment with discharge toxicity ................................29

7 RISK ASSESSMENT ..........................................................................................................29 

7.1 Risk to safety of ship................................................................................................29 

7.2 Risks to human health .............................................................................................29 

7.3 Risks to the aquatic environment...........................................................................30 

8 ASSESSMENT REPORT (G9: 4.3) ...................................................................................30 

9 MODIFICATION TO THE APPLICATION...................................................................31 

10 FINAL APPROVAL............................................................................................................31 
GESAMP-BWWG 3/9 

ANNEX 4 

Page 3 

I:\MEPC\56\2-2.doc 

1 INTRODUCTION 

This document clarifies the responsibility of the Administration in providing data to the 

Organization, and the procedures used by the Organization for evaluating applications, and is, as 

such, in accordance with resolution MEPC.126(53) on a Procedure for the approval of Ballast 

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

1.1 Terms and Definitions 

For the purpose of this paper, these definitions are intended to supplement those in the 

Ballast Water Convention to facilitate a consistent evaluation of submissions: 

.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 ñ either singularly or in combination ñ to remove, render 

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

Pathogens within Ballast Water and Sediments. 

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

Substances including any additives. This term also includes any Active 

Substances generated onboard for purposes of Ballast Water Management and any 

relevant chemicals formed in the Ballast Water Management system that make use 

of Active Substances to comply with the Convention. 

.4 Active Substances means a substance or organism, including a virus or a fungus 

that has a general or specific action on or against Harmful Aquatic Organisms and 

Pathogens. 

.5 Other components of a preparation means any other substances in a preparation, 

other than the Active Substance(s) or substances, other than Relevant Chemicals, 

produced during the treatment of ballast water. 

.6 Relevant Chemicals means transformation or reaction products that are produced 

during and after employment of the Ballast Water Management System in the 

Ballast Water or in the receiving environment and that may be of concern to the 

shipís safety, aquatic environment and/or human health. 

.7 Basic Approval means the approval of the use of Active Substances, according to 

their proposed manner of application, for prototype or type approval testing. The 

Basic Approval shall confirm that the available information does not indicate 

possible unacceptable adverse effects or a potential for unreasonable risk of such a 

testing to environment, human health, property or resources. In recommending a 

Basic Approval, potential risks during full-scale deployment on commercial ships 

shall be considered when possible. 

.8 Final Approval means the approval of a Ballast Water Management System 

using an Active Substance or Preparation to comply with the Convention and 

includes a review of the Type Approval tests in accordance with Guidelines for 
GESAMP-BWWG 3/9 

ANNEX 4 

Page 4 

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Approval of Ballast Water Management Systems. The Final Approval shall 

confirm that previous evaluations of risks to ship, crew and the environment 

including storage, handling and application of Active Substances or Preparations 

remain valid and the concerns have been addressed, as well as that the residual 

toxicity of the discharge conforms to the evaluation undertaken for Basic 

Approval. The risk evaluation at Final Approval should take qualitatively into 

account cumulative effects that may occur due to the nature of shipping and port 

operations. It should consider the uncertainties involved in the application for 

approval, and as appropriate, provide advice on how these uncertainties can be 

dealt with. 

.9 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. Experts working for GESAMP-BWWG act 

independently in their individual capacity. 

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. 

1.2 Abbreviations used in the text 

ABBREVIATIONS 

< less than 

< less than or equal to 

> greater than 

> greater than or equal to 

μg microgram 

 

b.p. boiling point 

bw body weight 

BWMS Ballast Water Management System 

 

°C degree Celsius (Centigrade) 

CAS Chemical Abstract Service 

cc cubic centimetre 

 

d day(s) 

 

EC50 effect concentration, 50% (median effective concentration) 

 

g gram 

GHS Globally Harmonized System 

G9 Procedure for approval of Ballast Water Management Systems that make

use of Active Substances (G9) Resolution MEPC.126(53) adopted

22 July 2005 

 
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ANNEX 4 

Page 5 

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ABBREVIATIONS 

h hour 

 

IARC International Agency for Research on Cancer 

IC50 inhibition concentration, 50%; 

ISO International Organization for Standardization 

IUPAC International Union of Pure and Applied Chemistry 

 

kg kilogram 

Koc organic carbon-water partition coefficient 

 

l litre 

LC50 lethal concentration, 50% 

LD50 lethal dose, 50% 

LOAEL lowest observed adverse effect level 

LDLO lowest lethal dose 

LOEL lowest observed effect level 

Log P logarithm of the octanol/water partition coefficient 

 

MEPC Marine Environment Protection Committee 

m.p. melting point 

mg milligram 

ml millilitre 

 

ng nanogram 

NOAEL no-observed-adverse-effect level 

NOEL no-observed-effect level 

 

OECD Organisation for Economic Co-operation and Development 

Organization the International Maritime Organization 

 

Pow octanol-water partition coefficient 

 

TLV threshold limit value 

US EPA United States Environmental Protection Agency 

 

WHO World Health Organization 

 

wt weight 

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 
GESAMP-BWWG 3/9 

ANNEX 4 

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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 of BWMS that make use of Active Substances 

A Ballast Water Management System that makes use of Active Substances accomplishes its 

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 itself or Preparation, as well as the Treated Ballast Water, should be subjected 

to toxicity testing in order to determine if an Active Substance or Preparation can be used and 

under which conditions the potential for harming the receiving environment or human health is 

acceptably low. 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.

2.3 Submission of an application for Basic Approval 

2.3.1 The manufacturer of the Ballast Water Management System should evaluate the Active 

Substance(s) or Preparation(s) and the potential discharge of treated Ballast Water in accordance 

with the approval criteria specified below (G9: 8.1.2.1). Upon completion, the manufacturer 

should prepare an Application Dossier for the Ballast Water Management System that makes use 

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

Organization. (G9: 8.1.2.2). 

2.3.2 The Administration should evaluate the Application Dossier and confirm that it is 

satisfactory and complete before submitting it to IMO. 

2.3.3 Applications for Basic Approval of the Ballast Water Treatment System, associated 

with 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. 

2.3.4 Application requirements: 

 .1 a complete Application Dossier including all documents identified in this 

paragraph (one paper version), including full study reports and full copies of 

literature. The complete Application Dossier 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; 

 .2 a non-confidential summary document (as provided to MEPC) to provide an 

overview of the application (electronic version); 

 .3 a summary of the key data should be provided in a tabular format (electronic 

version); 
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 .4 the assessment report (electronic version); and 

 .5 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 System using the Active Substance is approved, the 

following data should not be regarded as confidential: 

.1 the name and address of the Administration; 

.2 the names and addresses of the Administrations of the Active Substance and/or the 

preparation (if different); 

.3 the names and amount of the Active Substance(s) in the preparations and the name 

of the preparation; 

.4 the names of Other Components of Preparations, in particular those that are 

regarded as dangerous according to the UN GHS or relevant IMO regulations and 

contribute to the hazard documentation of the preparation; 

.5 the names of Relevant Chemicals that may be formed during or after application 

of the BWMS and that may be of concern for the receiving environment or human 

health; 

.5.1 the names of Other Chemicals that may be formed during or after the 

application of the BWMS with a technical justification for why they 

should not be treated as Relevant Chemicals 

.6 physical and chemical data concerning the Active Substance, the preparation and 

its components and Relevant Chemicals; 

.7 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; 

.8 a summary of the results of the tests required on the treated ballast water pursuant 

to Section 5.2 of the Procedure G9; 

.9 recommended methods and precautions against dangers resulting from handling, 

storage, transport and fire; 

.10 any means of rendering the Active Substance or preparation harmless; 

.11 Safety Data Sheets; 

.12 methods of chemical analysis; 
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.13 methods of disposal of the product and of its packaging; 

.14 procedures to be followed and measures to be taken in the case of spillage or 

leakage; 

.15 First Aid and medical advice to be given in the case of injury to persons; 

.16 all results of the PBT assessment and the risk characterisation pursuant to 

sections 5.1 and 5.3 of Procedure G9; and 

.17 the uncertainty analysis specified in chapter 6.4.3 of Procedure G9. 

2.5 Test Methods 

2.5.1 Tests should be carried out under internationally recognized guidelines (preferably OECD 

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

system (G9: 4.2.4) (e.g., GLP). Information may be derived from existing data where an 

acceptable justification is provided. Full copies of sources of data (e.g., literature papers) should 

be provided. 

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

test laboratory reports in support of each application. If submissions are lacking relevant 

information it may not be possible for the Group to conduct a thorough risk assessment. 

2.5.3 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. 

2.5.4 The Administration 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 

2.6.1 Alternative methods to testing on live 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 applicability domain of the method. 

2.6.2 Information that 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 should be submitted, which would help the Groupís 

evaluation of the Application Dossier. 
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2.7 Procedures and timelines 

2.7.1 Procedures for the 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 

are found to be necessary in order to finalize the evaluation, the Group may request that such data 

are submitted. 

2.7.2 The Administration will be informed, in writing, of the decision of the Organization. The 

Administration 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. 

2.7.3 It may be useful for a technical representative of the applicant to be available to the 

BWWG for an hour or so to answer questions regarding the system. 

3.0 DATA-SET REQUIRED IN THE APPLICATION 

3.0.1 The dossier should contain the information specified in G9. In cases where information 

requested in accordance with Procedure G9 has not been submitted and no justification for 

non-submission is provided, the Group may not be able to judge the reasons for not submitting 

the information that may influence its evaluation and development of recommendations. 

3.0.2 For Active Substances and/or Preparations including any of its components as 

appropriate, data on properties should be included. For Relevant Chemicals, data should be 

provided as well. 

3.0.3 Fate and effect testing should be performed in the laboratory with Active Substances and 

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

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

Therefore degradation and fate testing of Preparations may not be appropriate. 

3.0.4 For treated ballast water, the Administration should provide both acute and chronic 

toxicity data (G9: 5.2.2). The discharge toxicity tests should include chronic test methods 

performed as part of the land based type approval process with test species (fish, invertebrate, 

algae) that address the sensitive life stage (G9: 5.2.4). The results should include acute LC50 

values and chronic NOECs (G9: 5.2.5). Therefore 100% concentrations of samples of ballast 

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

3.0.5 Any reference to specific test methods in the following is indicative with the purpose of 

providing guidance to an Administration on possible methods that may be considered. Any other 

internationally recognised test method may also be used as well. 

3.1 Identification of the Substance or Preparation (G9: 4.1) 

3.1.1 Preparations: For each Preparation, the application should include the following 

information: (G9: 4.2.2): 

 .1 the Trade name; 

 .2 compositional information of the Preparation including: 
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 .1 the chemical (IUPAC) name of each component; 

 .2 the concentration of each component (liquids in g/l; solids in %w/w; gases 

in %v/v); 

 .3 the CAS number of each component; 

 .4 the UN number and proper shipping name of each component (where 

relevant); and 

 .5 an indication of whether the component is an Active Substance (AS) or a 

stabilizer or inhibitor or solvent, etc. 

3.1.2 Active Substance: For each Active Substance, the applicant should provide the 

following information: 

 .1 the Trade name (where relevant); 

 .2 the chemical (IUPAC) name; 

 .3 the CAS number; 

 .4 the UN number and proper shipping name (where relevant); 

 .5 the Molar mass; 

 .6 the empirical formula; 

 .7 the structural formula; 

 .8 the classification in accordance with the UN GHS system; 

 .9 the purity of the technical material and identification of impurities (chemical name 

and CAS-numbers, etc.); and 

 .10 the identity of any stabilisers or necessary additives. 

3.1.3 Relevant Chemicals (G9: 2.1.4): Where the process might produce by-products when 

reacting with ballast water, the applicant should provide the following information for those 

products deemed to be Relevant Chemicals: 

 .1 the Chemical (IUPAC) name; 

 .2 the CAS number; 

 .3 the Molar mass; 

 .4 the empirical formula; 

 
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.5 the structural formula; and 

 .6 the classification in accordance with the GHS system. 

3.1.4 Other Chemicals: Where the process might produce by-products not deemed to be 

Relevant Chemicals by the applicant, a justification for such a conclusion should be provided. 

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

sensitive and representative organisms (G9: 4.2.1.1) 

3.2.0 For every Active Substance or Preparation including any of its components, 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 

3.2.1.1 Short-term L(E)Cx from freshwater or saltwater representatives of three taxonomic 

groups (algae, crustaceans and fish) representing three trophic levels (e.g., OECD guidelines 201 

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

Toxicity Test), Mysid shrimp acute toxicity test (USEPA 850.1035)) should be accepted. To 

reduce further any remaining uncertainty, Administrations should, preferably, also submit data 

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

3.2.1.2 In the case of whole effluent testing, EPA, or equivalent, short term methods for 

estimating the acute toxicity of substances and discharge provide acceptable alternatives. 

3.2.1.3 Such acute aquatic toxicity data are required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; 

 .3 Relevant Chemicals; and 

 .4 Treated ballast water (G9: 5.2.3). 

3.2.2 Chronic aquatic toxicity 

3.2.2.1 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, Administrations 

should preferably also submit two long-term NOECs from additional marine taxonomic groups 

(e.g., echinoderms, molluscs). 

3.2.2.2 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. 

3.2.2.3 Such chronic aquatic toxicity data are required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; 
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 .3 Relevant Chemicals; and 

 .4 Treated ballast water (fish, invertebrate, plant) (G9: 5.2.3). 

3.2.3 Endocrine disruption 

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

as in vitro tests may be conducted 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 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. 

3.2.3.2 Such information on endocrine disruption is required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.2.4 Sediment toxicity 

3.2.4.1 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 

considered relevant only if log Kow > 3 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. 

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

specific marine sediment assessment is necessary. 

3.2.4.3 Such information on sediment toxicity is required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; 

 .3 Relevant Chemicals; and 

 .4 Treated Ballast water. 

3.2.5 Bioavailability/biomagnification/bioconcentration 

3.2.5.1 If log Pow > 3, testing of the bioaccumulation potential should be considered taking 

into account the following points: 

 .1 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; 
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 .2 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; and 

 .3 There are no data requirements on bio-availability since it is considered that the 

bio-availability 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. 

3.2.5.2 Such information on bioavailability/biomagnification/bioconcentration is required for: 

 .1 Active Substances; 

 .2 Any components of a preparation; and 

 .3 Relevant Chemicals. 

3.2.6 Food web/population effects 

3.2.6.1 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. 

3.2.6.2 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: 

 .1 one long-term NOECs based on reproduction studies with a bird species; and 

 .2 two NOECs from long-term studies with two mammalian species (from 

section 2.3 below). 

3.2.6.3 Such information related to the food web/population effects is required for: 

 .1 Active substances; and 

 .2 Relevant Chemicals. 

3.3.0 Data on mammalian toxicity (G9: 4.2.1.2) 

3.3.0.1 Information that is deemed to be unnecessary need not be supplied. However, in such 

cases a scientific justification should be submitted in order to explain why the data have not been 

provided. In general, testing with vertebrate animals should be avoided if other type of 

information is available that allows an assessment of hazards and risks to humans. Such 

alternative information may be obtained by validated in vitro methods, Quantitative Structure 

Activity Relationships (QSAR), grouping or read-across with similar substances. If available, 

human experience or epidemiological evidence should be presented and discussed. 

3.3.0.2 In general, information should be provided on the Active Substance and the 

Preparation including any of its components, as appropriate. Information on Relevant Chemicals 

formed during or after application of the BWMS should be provided as well. 
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3.3.1 Acute toxicity 

3.3.1.1 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 should be tested by 

inhalation. 

3.3.1.2 The submission of dermal and/or inhalation studies instead of or in addition to oral 

studies may be requested depending on the physico-chemical properties of the substance, the 

proposed or potential application of the substance/products. 

3.3.1.3 Such information on acute toxicity is required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.3.2 Effects on skin and eye 

3.3.2.1 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) or Preparation(s). 

3.3.2.2 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, an eye irritation test shall not be carried out. Results from 

in vitro test methods, which are close to validation by recognized organizations, may be 

submitted. 

3.3.2.3 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 should 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. 

3.3.2.4 Such information related to the effects on skin and eyes is required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals 

3.3.3 Repeated-dose toxicity 

3.3.3.1 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. 
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3.3.3.2 Such information on repeated dose toxicity is required for: 

 .1 Preparation including any of its components; 

 .2 Active Substance; and 

 .3 Relevant Chemicals. 

3.3.4 Chronic toxicity 

3.3.4.1 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. 

3.3.4.2 Any chronic study can be combined with a carcinogenicity study. 

3.3.4.3 Such information on chronic toxicity is required for: 

 .1 Preparation including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.3.5 Developmental and reproductive toxicity 

3.3.5.1 Testing should include: 

.1 a two-generation reproduction and fertility study (OECD guideline 416 ñ 

Two-Generation Reproduction Toxicity Study); and 

.2 a prenatal developmental toxicity (teratogenicity) study in two species 

(OECD guideline 414 ñ Prenatal Developmental Toxicity Study). 

3.3.5.2 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. 

Such information on developmental and reproductive toxicity is required for: 

 .1 Preparation including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.3.6 Carcinogenicity 

3.3.6.1 Carcinogenicity studies should be performed with one rodent and one other 

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

be needed where justification demonstrates that these tests are not necessary. Carcinogenicity 

studies may be combined with the chronic toxicity studies. 

3.3.6.2 Such information on carcinogenicity is required for: 
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 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.3.7 Mutagenicity/genotoxicity 

3.3.7.1 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 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. 

3.3.7.2 Such information on mutagenicity and genotoxicity is required for: 

 .1 Preparations including any of its components; and 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.3.8 Toxicokinetics 

3.3.8.1 Basic data on the toxicokinetics of Active Substances and other components of a 

preparation as well as Relevant Chemicals should be included. Information on absorption, 

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 physico-chemical data to reduce 

the need for any specific dermal toxicity testing. 

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

(G9: 4.2.1.3) 

3.4.0.1 The route of abiotic and biotic degradation of the Active Substances, components of a 

preparation and Relevant Chemicals 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). 

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

normalized distribution coefficient (Koc) of the Active Substances, components of a preparation 

and Relevant Chemicals should be determined (G9: 5.3.6). 

3.4.0.3 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) 

3.4.1.1 Testing should include: 
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 .1 a study on hydrolysis at pH 5, 7, and 9 under aerobic conditions according to 

OECD guideline 111; 

 .2 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; 

 .3 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; and 

 .4 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). 

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

studies should be conducted: 

 .1 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 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); 

 .2 a study on aerobic transformation of low concentrations of organic contaminants 

according to OECD guideline 309 (Aerobic Mineralization in Surface Water ñ 

Simulation Biodegradation Test) or equivalent guidelines, using fresh or marine 

water depending on the kind of aquatic ecosystem where discharge is intended; 

and 

 .3 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). 

3.4.1.3 Such information on the modes of degradation is required for: 

 .1 Active Substances; 

 .2 any other components of preparations; and 

 .3 Relevant Chemicals. 

3.4.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient 

3.4.2.1 Testing should include: 

 .1 data on bioconcentration and biomagnification, which have already been detailed 

earlier in this document; 
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 .2 a study into the log Pow according to OECD guideline 107 (Partition Coefficient 

(n-octanol/water): Shake Flask Method), OECD guideline 117 (Partition 

coefficient ñ n-octanol/water HPLC method) or equivalent test guidelines. For 

very hydrophobic compounds a slow stirring method (OECD 123 (Partition 

coefficient ñ slow stirring method) is required; 

 .3 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)(OECD 106). 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. 

3.4.2.2 Such information on bioaccumulation and partition coefficients is required for: 

 .1 Active Substances; 

 .2 any other components of preparations; and 

 .3 Relevant Chemicals. 

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

water, marine and fresh waters) 

3.4.3.1 The route of degradation in the higher tier simulation tests specified under section 3.4.1 

of this document should be characterized, based on a mass balance including mineralization and 

formation of bound residues. Reaction or transformation products formed that may be 

considered as Relevant Chemicals should be identified. 

3.4.3.2 Such information on persistence and metabolites is required for: 

 .1 Active Substances; 

 .2 any components of preparations; and 

 .3 Relevant Chemicals. 

3.4.4 Reaction with organic matter 

3.4.4.1 The reaction of radicals produced by the action of Active Substances1

 with organic 

matter shall be addressed qualitatively as to identify products of concern to the environment and, 

where possible, quantitatively as to identify environmental concentrations. 

3.4.4.2 Radical producing chemicals are capable of forming halogenated (chlorinated, 

brominated) hydrocarbons that 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. 

 

1 MEPC 55/2/6, paragraph 33. 
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3.4.4.3 Such information on the reaction with organic matter is required for: 

 .1 Active Substances; and 

 .2 Relevant Chemicals. 

3.4.5 Potential physical effects on wildlife and benthic habitats 

3.4.5.1 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. 

3.4.5.2 Such data on the potential physical effects on wildlife and benthic habitats are required 

for: 

 .1 Preparations including any of its components; 

 .2 Active Substance; 

 .3 Relevant Chemicals; and 

 .4 Treated Ballast water. 

3.4.6 Potential residues in seafood 

3.4.6.1 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. 

3.4.6.2 Such data on potential residues in seafood are required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.4.7 Any known interactive effects 

3.4.7.1 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. 

3.4.7.2 Such information on known interactive effects is required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 
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3.5 Physical and chemical properties for the Active Substances and preparations and 

treated ballast water, if applicable (G9: 4.2.1.4) 

Data should be submitted for the Active Substances, preparations including any of its 

components, the treated ballast water on board and the Relevant Chemicals to allow for the 

identification of hazards to the crew, the ship and the environment. 

3.5.1 Melting point 

Data on the melting point are required for: 

 .1 Preparations including any of its components; and 

 .2 Active substances. 

3.5.2 Boiling point 

Data on the boiling point are required for: 

 .1 Preparations including any of its components; and 

 .2 Active Substances. 

3.5.3 Flammability (flash point) 

Data on the flash point are required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.5.4 Density (relative density) 

Data on the density are required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Treated Ballast water. 

3.5.5 Vapour pressure, vapour density 

Data on the vapour pressure and vapour density are required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.5.6 Water solubility/dissociation constant 

Data on the water solubility and dissociation constants are required for: 

 
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.1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.5.7 Oxidation/reduction potential 

Data on the oxidation/reduction potentials are required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; 

 .3 Relevant Chemicals; and 

 .4 Treated Ballast water. 

3.5.8 Corrosivity to the materials or equipment of normal ship construction 

Data on the corrosivity to materials of construction are required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; 

 .3 Relevant Chemicals; and 

 .4 Treated Ballast water. 

3.5.9 Auto-ignition temperature 

Data on the auto-ignition temperature are required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.5.10 Explosive properties 

Data on the explosive properties are required for: 

 .1 Preparations;2

 .2 Active Substance; and 

 .3 Relevant Chemicals. 

3.5.11 Oxidizing properties 

Data on the oxidizing properties are required for: 

 .1 Preparations; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

 

2 MEPC 55/2/6, paragraph 34. 
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3.5.12 Surface tension 

Data on the surface tension are required for: 

 .1 Preparations; and 

 .2 Active Substance. 

3.5.13 Viscosity 

Data on the viscosity are required for: 

 .1 Preparations; and 

 .2 Active Substances. 

3.5.14 Thermal stability and identity of relevant breakdown products 

Data on the melting point are required for: 

 .1 Preparations including any of its components; and 

 .2 Active Substances. 

3.5.15 Reactivity towards container material 

Data on the reactivity towards container materials are required for: 

 .1 Preparations including any of its components; 

 .2 Active substances; 

 .3 Relevant Chemicals; and 

 .4 Treated ballast water. 

3.5.16 pH 

Data on the pH are required for: 

 .1 Preparations; and 

 .2 Treated Ballast water. 

3.5.17 Salinity 

Data on the salinity are required for: 

 .1 Treated Ballast water. 

3.5.18 TOC, DOC, % particulate matter 

Data on the TOC, DOC and % of particulate matter are required for: 

 .1 Treated Ballast water. 
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3.5.19 Other known relevant physical or chemical hazards 

Data on the any other known relevant physical or chemical hazards are required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; 

 .3 Relevant Chemicals; and 

 .4 Treated Ballast water 

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

Recognizing that some methods may only cover a range of chemicals e.g., TRO, analytical 

methods at environmentally relevant concentrations are required for: 

 .1 Preparations including any of its components; 

 .2 Active Substance; and 

 .3 Relevant Chemicals. 

4 USE OF THE ACTIVE SUBSTANCE OR THE PREPARATION 

4.1 The manner of application 

4.1.1 The proposal should include the manner of application of the Active Substance or the 

preparation for the Ballast Water Management (BWM), including required dosage and retention 

time (G9: 4.2.6). 

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

addressing the following items: 

 .1 the technical manual or instructions by the Administration, 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; 

 .2 recommended methods and precautions concerning handling, use, storage, and 

transport; 

 .3 procedures to be followed in case of fire, and the nature of reaction products, 

combustion gases, etc.; 

 .4 Emergency measures in case of an accident; 

 .5 an indication of the possibility of destruction or decontamination following release 

in the marine environment; 

 .6 procedures of waste management of the Active Substance; 

 
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.7 the possibility of reuse or recycling; 

 .8 the possibility of neutralization; 

 .9 conditions for controlled discharge; and 

 .10 the amount of substance onboard ship. 

4.1.3 Appropriate risk management measures (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. 

4.1.4 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) 

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

been prepared for the United Nations 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 The Revised GESAMP Hazard Evaluation 

Procedure for Chemical Substances Carried by Ships, which reflects the GHS for marine 

environmental protection aspects. The Administration is referred to this document for a more 

detailed guidance on hazard identification. 

5.2 The Classification under GHS and the (Material) Safety Data Sheet ((M)SDS) should be 

given for all components of a Preparation (G9: 6.3.2). Where a component is not classified as 

hazardous under GHS, this should also be clearly stated. 

5.3 The same information should also be given for Relevant Chemicals and other by-products 

produced by the system unless a clear justification is provided e.g., the half-life of the by-product 

is so short that the hazards cannot be determined. Key data for these should be summarized in 

the Key Data Summary Table. 

6 RISK CHARACTERIZATION 

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

6.1.1 Persistence (G9: 5.1.1.1) 

6.1.1.1 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. 

6.1.1.2 For persistence and degradation data requirements, see 3.4.1 and 3.4.3 of this 

document. 
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6.1.2 Bioaccumulation (G9: 5.1.1.2) 

6.1.2.1 The assessment of the bioaccumulation potential should use measured bioconcentration 

factors in marine (or freshwater organisms). Where test results are not available, the assessment 

of the bioaccumulation potential of an organic substance may be based on the log Pow. 

For bioaccumulation data requirements, see 3.2.5 and 3.4.2 of this document. 

6.1.3 Toxicity tests (G9: 5.1.2.3) 

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

be used for the assessment of the toxicity criterion. 

6.1.3.2 For ecotoxicity data requirements, see 3.2 of this document. 

6.1.3.3 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 

Criterion PBT criteria 

Persistence Half-life: 

> 60 days in marine water, or 

> 40 days in freshwater,* or 

> 180 days in marine sediments, or 

> 120 days in freshwater sediments 

Bioaccumulation Experimentally determined BCF > 2,000, or if no 

experimentally BCF has been determined, Log Pow≥3 

Toxicity Chronic NOEC < 0.01 mg/l 

* ) For the purpose of marine environmental risk assessment half-life data in freshwater and freshwater sediment 

can be overruled by data obtained under marine conditions. 

Active Substances or Preparations identified as PBT substances will not be recommended for 

approval in accordance with paragraph 6.4.1 of the Procedure. 

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 aquatic toxicity of the Active Substance, preparation including any of its 

components and Relevant Chemicals formed during and after application of the BWMS. 

6.2.1 Basic approval 

6.2.1.1 Testing should be performed in laboratory of a sample prepared by simulation of the 

BWMS (G9: 5.2.1). 
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6.2.1.2 A system using 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). 

6.2.2 Final approval 

6.2.2.1 Full-scale land-based toxicity tests with samples of ballast water treated with the 

BWMS under test conditions and a scale as defined in Guidelines (G8) during onboard testing 

should be conducted (G9: 5.2.2). 

6.2.2.2 In accordance with Regulation D-3.2, a Ballast Water Management system using an 

Active Substance or Preparation to comply with the Convention (that received basic approval) 

must be approved by the Organization. 

6.2.3 Determination of holding time 

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

discharge, i.e., the necessary dilution of the treated ballast water. 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 characterization and analysis 

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

6.3.1.1 The reaction with organic matter of Active Substances and preparations including any 

of its components should be addressed qualitatively and quantitatively, so as to identify Relevant 

Chemicals that may be of concern to the environment. 

6.3.2 Characterization of degradation route and rate (G9: 5.3.5) 

6.3.2.1 The route and rate of abiotic and biotic degradation of the Active Substances and 

Preparations, including any of its components, under aerobic and anaerobic conditions (see 2.4.1 

above) should be assessed, resulting in the characterization of the Active Substances, 

Preparations including any of its components and Relevant Chemicals in terms of degradation 

rates under specified conditions (e.g., pH, redox, temperature). 

6.3.3 Prediction of discharge and environmental concentrations 

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

including any of its components and Relevant Chemicals, the discharge concentrations at 

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

6.3.3.2 Environmental concentrations after discharge of treated ballast water under controlled 

conditions during development and type approval tests should be estimated (e.g., by a suitable 

model simulating the test conditions) and provided in the application dossier for Basic Approval. 

Concentrations of treated ballast water, Active Substances, Relevant Chemicals and other 

components of Preparations, as appropriate, should be estimated. 
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6.3.3.3 Environmental concentrations, under suitable emission scenarios to be developed 

describing typical full-scale use and discharge situations, should also be estimated for treated 

ballast water, Active Substances, Relevant Chemicals and other components of Preparations, as 

appropriate. 

6.3.4 Assessment of potential for bioaccumulation 

6.3.4.1 For Active Substances, Preparations including any of its components and Relevant 

Chemicals, 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 

6.3.5.1 The effect assessment of the Active Substances, Preparations including any of its 

components 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), (G9: 5.3.9). 

6.3.5.2 An effect assessment could also be prepared on secondary poisoning to mammalian 

and avian top-predators where relevant. 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 might be 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). 

6.3.5.3 An assessment of effects to sediment species should be conducted unless the potential 

of the substance of concern to partition into the sediment is low (e.g., Koc < 500 L/kg) 

(G9: 5.3.11). 

6.3.5.4 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). 

6.3.6 Effects on aquatic organisms 

6.3.6.1 For assessment of effects to the aquatic environment, appropriate Predicted 

No-Effect-Concentrations (PNEC) should be derived. A PNEC is typically derived at a level 

that, when not exceeded, protects the aquatic ecosystem against toxic effects of long-term 

exposures. However, for situations where only short-term exposures are expected, an additional 

PNEC for short-term exposure may be useful. PNEC values are normally derived from shortterm and/or long-term aquatic toxicity results for relevant aquatic species by dividing the lowest 

available effect concentration with an appropriate assessment factor. For the aquatic effect 

assessment, the assessment factors, given in Table 2, should be guiding although these may be 

altered on a case-by-case basis based on expert judgement. In cases where a comprehensive data 
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set is available, the PNEC may be derived with a mathematical model of the sensitivity 

distribution among species. 

6.3.6.2 PNEC values should be derived for any substances that may be found in treated ballast 

water in concentrations that may be of concern for the aquatic environment. The relevance of 

deriving PNEC values for Active Substances, any other components of preparations and/or 

Relevant Chemicals should thus be considered. 

6.3.6.3 When aquatic toxicity data are available only for freshwater species but a PNEC for the 

marine environment (PNECsaltwater) is needed, this may be derived by applying a higher 

assessment factor than for the derivation of a PNECfreshwater to reflect the greater uncertainty in 

protecting sensitive species in saltwater environments. Where data are 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. 

6.3.6.4 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. 

 Table 2 Effect assessment for deriving PNECs for freshwater and saltwater 

 Assessment Factor 

Data set PNEClong PNECshort 

Freshwater assessment 

Lowest short-term L(E)C50 from fresh water species 

representing three trophic levels 

1000 10-100 

Lowest chronic NOEC from three freshwater or 

saltwater species representing three trophic levels 

10 

Saltwater assessment 

Lowest short-term L(E)C50 from marine species 

representing three trophic levels 

1000 10-100 

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 

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 

6.3.7 Effects on sediment 

6.3.7.1 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 and 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 sediment-bound 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 
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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 

6.3.8 Comparison of effect assessment with discharge toxicity 

The results of the effect assessment of the substances that are likely to be present in the treated 

ballast water at discharge are compared to the results of the toxicity testing of the treated ballast 

water. Any unpredicted results (e.g., lack of toxicity or unexpected toxicity in the treated ballast 

water at discharge) should give rise to a further elaboration on the effect assessment (G9: 5.3.14). 

7 RISK ASSESSMENT 

7.1 Risk to safety of ship 

7.1.1 The potential risk to the safety of the ship and crew raised by the operation of the BWMS 

should be assessed, taking into account the identified risk mitigation measures to be applied and 

any relevant legislative requirements such as provided in SOLAS and MARPOL. Potential risk 

to the ship/crew may include, inter alia: 

 .1 increased corrosion; 

 .2 fire and explosion; 

 .3 storage and handling of the substances; 

 .4 contact with, or inhalation of, process products; and 

 .5 noise. 

7.2 Risks to human health 

7.2.1 The human health risk assessment should follow generally accepted guidelines including 

acute and long-term exposure situations. The risk assessment should entail hazard identification 
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and, as appropriate, dose (concentration) ñ response (effect) assessment, exposure assessment 

and risk characterization. The population groups deemed to be at risk and so to be examined 

should include crew, passengers and all personnel, including 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 and of the Ballast Water Management System that should then be 

assessed by the Administration concerned. 

Health effects in humans 

7.2.2 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). 

7.3 Risks to the aquatic environment 

7.3.1 The potential risks to the aquatic environment during experimental development and type 

approval testing should be assessed. 

7.3.2 When no aquatic toxicity of the treated ballast water at discharge is found either through 

direct testing of the treated ballast water or if the estimates ratios between predicted 

concentrations of the Active Substance, components of preparations or Relevant Chemicals, as 

appropriate, and the respective PNEC values are below 1, no further assessment of direct toxic 

effects to the aquatic environment is necessary. 

7.3.3 In other cases, the dilution necessary to ensure that the PNEC values are not exceeded 

should be calculated by an appropriate model for relevant controlled use and discharge scenarios. 

7.3.4 The potential risks to the aquatic environment resulting from full-scale deployment 

onboard ships and discharge of treated ballast water under representative conditions should be 

assessed. The specific assessment might await further development of an appropriate Emission 

Scenario Document for discharge of treated ballast water. 

8 ASSESSMENT REPORT (G9: 4.3) 

The Assessment report referred to in point 4.3 of the Procedure shall at least provide: 

 .1 an overview of the data and endpoints on which the risk characterization 

according to section 6 of the Procedure is based including a description of the 

quality of test reports; 

 .2 an assessment of risks to the safety of ships, crew (human health), the 

environment and resources (e.g., fisheries) during development and type approval 

testing as well as during full-scale deployment onboard ships in accordance with 

section 6 of the Procedure; 
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 .3 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; 

 .4 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 that 

were determined experimentally, along with an identification or description of the 

modelling methodology; 

 .5 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; 

 .6 a qualitative statement of the level of uncertainty in the evaluation referred to 

under the preceding paragraph; and 

 .7 a detailed description of risk management possibilities, e.g., for neutralization of 

the 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. 

9 MODIFICATION TO THE APPLICATION 

9.1 Administrations 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). 

9.2 Administrations 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). 

10 FINAL APPROVAL 

Further guidance on methodology and testing and sampling for final approval to be added. 
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Key Data Summary Form for the Procedure for approval of BWM Systems that Make 

Use of Active Substances

(For each piece of data selected for the Summary Form, the range of data that this has been 

chosen from should be included as an appendix e.g. If the Summary Form includes an Acute Oral 

LD50 for a Rat, the appendix should include the complete list of values identified in the literature 

from which this value was chosen as a proposal to the BWWG) 

1 Chemical Identification

Trade Name of Preparation 

Composition of Preparation 

Component Chemical Name CAS Number Concentration (%) AS, RC or Other* 

 

*

 Indicate whether the chemical is believed to be one of the following, giving justification for 

each proposal: 

AS = Active Substance 

RC = Relevant Chemical 

Other = Any other Chemical e.g. solvent 

List of ALL potential by-products produced in ballast water 

Chemical Name CAS Number Concentration 

(%)

(bio)degradation 

rate or half-life 

 

Notes: 1 A separate index for the Active Substance(s) and all by-products should be created 

unless a scientific explanation is provided to justify not including them. 

 2 A chemical analysis should also be provided to show the concentration of possible 

by-products produced in the treated ballast water. Such analyses should be carried 

out to a level of detection commensurate with the level of naturally occurring 

chemical in seawater and/or the level that could be justified as not being 

hazardous to human health or the environment, where appropriate. 

 3 A clear description of, or reference to, the chemical analysis should be provided 

along with the length of time, after treatment, that the analysis was carried out. It 

is recommended that there should be: 

 .1 one analysis carried out following the shortest possible time that the 

treated ballast water would be permitted to be discharged; and 

 .2 one analysis carried out [5] five days later.
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Data required for each component of the Preparation and by-product produced 

in ballast water

Chemical Name 

ÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖ. 

 Where the applicant considers that it is not necessary to complete the data form for a 

given chemical, a full justification must be given (e.g. the 1⁄2-life of the chemical is only a 

few seconds and so will have disappeared by the time the ballast water is discharged into 

the sea) 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data 

Species LC50 

(mg/l/duration) 

Reference/Comments/Justification 

for missing data 

Fish 

Crustacea 

Algae 

2.2 Chronic Aquatic Toxicity Data 

Species LC50(mg/l/duration) 

or 

NOEC(mg/l/duration

Reference/Comments/Justification 

for missing data 

Fish 

Crustacea 

Algae 

2.3 Information on Endocrine Disruption

Species Information Reference/Comments/Justification 

for missing data 

Fish 

Crustacea 

Algae 

2.4 Sediment Toxicity

Species Information Reference/Comments/Justification 

for missing data 

Fish 

Crustacea 

Algae 
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2.5 Bioavailability/Biomagnification/Bioconcentration

Log Pow Reference/Comments/Justification for missing data 

BCF 

2.6 Food Web/Population Effects 

A description of potential food web and population effects is required supported by a full 

justification 

3 MAMMALIAN TOXICITY 

3.1 Acute mammalian Toxicity

 Value Species Reference/Comments/Justification 

 for missing data 

Oral LD50 (mg/l) 

Dermal LD50 (mg/l) 

Inhalation LC50

(mg/l/4h) 

 

3.2 Corrosion/Irritation

 Species Method Results 

(including scores 

where available) 

Reference/Comments/Justification 

for missing data

Skin 

Eye 

3.3 Sensitization 

 Species Method 

(e.g. 

Buehler, 

M&K) 

Results 

(Sensitizer 

Y/N) 

Reference/Comments/Justification 

for missing data

Skin 

Inhalation 

3.4 Repeated-Dose Toxicity

Exposure Route 

Exposure Duration 

Exposure dose 

Species 

Method 

Results 

NOAEL 

NOEL 

Reference/Comments/ 

Justification for missing data 
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3.5 Development and Reproductive Toxicity

Exposure Route 

Exposure Duration 

Exposure dose 

Species 

Method 

Results 

NOAEL 

NOEL 

Reference/Comments/ 

Justification for missing data 

3.6 Carcinogenicity/Mutagenicity/Reprotoxicity

 Species Method Details Results Reference/Comments/ 

Justification for 

missing data 

Carcinogenicity 

Mutagenicity 

Reprotoxicity 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic) 

 Sea 

water or 

Fresh 

Water 

Test 

Duration 

Results Break-down 

products 

Reference/Comments/ 

Justification for 

missing data 

Hydrolysis 

at pH 5 

 

Hydrolysis 

at pH 7 

Hydrolysis 

at pH 9 

Biodegradation 

1/2 - Life NR 

4.2 Partition Coefficients

 Method Results Reference/Comments/ Justification 

for missing data

Log Pow 

Koc 
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4.3 Persistence and Identification of Main Metabolites

 Method Results Reference/Comments/ Justification 

for missing data

Persistence 

4.4 Reaction with Organic Matter 

4.5 Potential Physical Effects on Wildlife and Benthic Habitats 

4.6 Potential Residues in Seafood 

4.7 Any Known Interactive Effects 

5 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER IF APPLICABLE 

Property Value Reference/Comments/ Justification 

for missing data 

Melting point (°C) 

Boiling point (°C) 

Flammability (flash point for liquids; °C) 

Density (20 °C; kg/m3) 

Vapour pressure (20 °C; Pa) 

Vapour density (air = 1) 

Water solubility (temp; effect of pH; mg/l) 

pH in solution 

Dissociation constant (pKa) 

Oxidation-reduction potential 

Corrosivity to material or equipment 

Reactivity to container material 

Auto-ignition temperature (°C) 

Explosive properties 

Oxidising properties 

Surface tension 

Viscosity 

Thermal stability and identity of 

breakdown products 

Other physical or chemical properties 

6 OTHER INFORMATION

6.1 Analytical Methods for Measuring the Concentration at environmentally Relevant 

Concentrations 

Method 

Applicability 

Sensitivity 

Reference/Comments/ Justification 

for missing data 
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6.2 Material Safety Data Sheet provided (Yes/No)ÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖ 

6.3 GHS Classification ÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖ. 

6.4 Risk Characterization 

Persistent (y/n) Bioacumulative 

(y/n) 

Toxic (y/n) Reference/Comments/ Justification for 

missing data 

 

***

GESAMP-BWWG 3/9 

I:\MEPC\56\2-2.doc 

ANNEX 5 

REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES 

PureBallast Management System 

Submitted for Basic Approval by Sweden as MEPC 55/2/5 and 

by Norway for Final Approval as MEPC 56/2/1 

0 SUMMARY 

0.1 The Group noted that the PureBallast System uses a combination of filtration and 

Advanced Oxidation Technology that produces free radicals in order to treat ballast water. These 

free radicals were expected to have half-lives in the order of micro seconds to milliseconds and, 

for this reason, it was neither necessary nor practical to provide their physical characteristic or 

toxicological profiles. 

 

0.2 The Group were also satisfied that, as the system does not involve the storage or 

generation of chemicals to treat ballast water, there were no associated safety problems. 

0.3 However, it was recognized that the process would generate free radicals that might react 

with naturally occurring organic molecules to form by-products with safety and environmental 

concerns. 

0.4 Based on results from chemical analyses of treated ballast water, the Group concurred 

with the views of the applicant that it was not necessary to provide toxicological and 

ecotoxicological data on these products and that an evaluation of the effects of treated ballast 

water should suffice to provide a recommendation regarding both Basic Approval and Final 

Approval. 

0.5 The Group noted that the G9 procedures require that ìProposed procedures for the use 

and technical equipment introduced needs to be taken into accountî. However, it was also noted 

that neither procedures for use of the treatment system, nor confirmation that the equipment is 

suitable for use on board a ship had been provided for evaluation by the Group. As a result, the 

Group proposed that the following procedures should be properly documented so that they can be 

taken into account by the Administration prior to issuing a Type Approval Certificate should 

MEPC grant Final Approval: 

 .1 the UV lamps require a ìwarm-upî time before the system is ready for use. Full 

operating and maintenance procedures require to be evaluated to provide all 

necessary considerations for operators and crew safety; 

 .2 the electric power requirement of the system will not be an insignificant additional 

ship service demand. It requires to be confirmed that the equipment meets all 

regulatory standards for equipment to be installed on board a ship, both with 

regard to construction and prevention of electric shock to personnel; and 

 .3 the submission indicated that the corrosivity to the materials or equipment of 

normal ship construction due to possible formation of certain compounds by use 

of the system was to be further investigated. The results of this further 

investigation should be assessed to confirm that any corrosion effect remains 

acceptable. 
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0.6 As a result, the Group recommended that Final Approval be granted to this system on the 

conditions that the Administration verify that the concerns raised with regard to the ship and 

crew safety have been fully addressed prior to issuance of a Type Approval Certificate. 

1 INTRODUCTION

1.1 The data used to evaluate this system were extracted from that supplied by Sweden in 

document MEPC 55/2/5 that was supported by additional confidential information provided to 

the GESAMP-BWWG Secretariat and that supplied by Norway in document MEPC 56/2/1, that 

also was supported by additional confidential information provided to the GESAMP-BWWG 

secretariat. 

2 COMPLETENESS OF THE DOSSIER 

2.1 The Group noted that the applicant had provided some ecotoxicity data for the treated 

ballast water that demonstrated a lack of toxicity. Whilst the Group identified some 

shortcomings associated with these toxicity studies, it was envisaged that any new tests were 

unlikely to reveal different results because of the very short-lived radicals generated by the 

system. 

2.2 The Group also considered that the Level of Quantification (LOQ) associated with the 

chemical analysis of the potential by-products measured was too high and that much lower 

detection limits are achievable. 

2.3 Some concern was expressed that some of the chemicals analysed for might still be 

produced at levels lower than the detection limits used by the applicant. 

2.4 Whilst no other physico-chemical properties, fate and behaviour in the environment and 

mammalian toxicity data had been provided, the Group agreed that this was not necessary, from 

the aquatic toxicity perspective, due to the low level of by-products being produced by the 

system. However, it was considered that, even at such low levels, there might be some potential 

for causing a risk to human health. 

2.5 However, the Group agreed that information should have been provided describing the 

actual use onboard of the equipment together with a statement that it was suitable for use 

onboard. Nevertheless, the Group considered that, providing the Administration addresses these 

points when considering Type Approval, this aspect should not prevent the Group from 

recommending that both Basic Approval and Final Approval be granted to this system. 

3 DESCRIPTION OF THE BWMS

3.1 Overview of the system 

3.1.1 The submission indicates that the system is intended to treat the ballast water both on 

uptake and at discharge. The use of a secondary discharge treatment is to address any potential 

for re-growth of organisms in the ballast tank. The treatment system consists of the following 

two phases: 
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 .1 Filtration (50μm) (uptake only) for removal of larger particles and organisms as 

well as to reduce the level of sediments in the ballast tanks, it is informed that the 

filter used is of the automatic back flushing type; 

 .2 Treatment with the AOT (Advanced Oxidation Technology) that involves: 

 .1 the in situ formation of free radicals; and 

 .2 direct photo-effects. 

 The submission states that a special UV light wavelength spectrum is used in 

combination with a TiO2 based catalyst. It is confirmed that no substances are 

added in the process. 

3.1.2 The Group also noted that the description of the system indicated that it incorporated full 

automation, including CIP (cleaning in place) and alarm facilities. 

3.2 Active Substances, Relevant Chemicals and Other Chemicals 

3.2.1 It was noted that the proposed system involves filtration followed by a patented system 

for producing free radicals in situ with the aid of a titanium catalyst. As a result, chemicals are 

neither required to be stored onboard nor generated on demand. 

3.2.2 However, it was recognized that the process would generate free radicals that were 

expected to have half-lives in the order of micro seconds to milliseconds, but that might react 

with naturally occurring organic molecules to form by-products with safety and environmental 

concerns. Whilst agreeing that such free radicals should be regarded as either Active Substances 

or Relevant Chemicals, it was agreed that, due to their short half-life it was neither necessary nor 

practical to provide their physical characteristic or toxicological profiles.

3.2.3 It was noted that the applicant had identified the following chemicals as being possible 

resultant products of the treatment system and had analysed the ballast water for them, as part of 

the application for Basic Approval, with the following results: 

Test Compound Before treatment After treatment 

Bromate <0.01 mg/L <0.01 mg/L 

Absorbed organic halogens 76 μg Cl/L 77 μg Cl/L 

Extractable organic halogens <2 μg/L <2 μg/L 

Chlorophenols (18 substances) < 0.01 μg/L < 0.01 μg/L 

Chloroform (CHCl3) 2 μg/L 1 μg/L 

Bromoform (CHBr3) <1 μg/L <1 μg/L 

Dichlorobromomethane (CHCl2Br) <1 μg/L <1 μg/L 

Dibromochloromethane (CHClBr2) <1 μg/L <1 μg/L 

3.2.4 The Group considered that, although the submission indicated that these analyses have 

been carried out using the best available techniques it was not convinced as the Level of 

Quantification (LOQ) is considered too high in some cases as can be seen from the above table. 
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ANNEX 5 

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I:\MEPC\56\2-2.doc 

3.2.5 However, the Group also noted the following analyses of chemicals that had been 

submitted as part of the application for Final Approval. 

Test Compound Before treatment After treatment 

Absorbed organic halogens 450 μg Cl/L 570 μg Cl/L 

Extractable organic halogens <50 μg/L <50 μg/L 

Chlorophenols (18 substances) <0.1 μg/L <0.1 μg/L 

Chloroform (CHCl3) <0.3 μg/L <0.3 μg/L 

Bromoform (CHBr3) <0.2 μg/L <0.2 μg/L 

Dichlorobromomethane (CHCl2Br) <0.1 μg/L <0.1 μg/L 

Dibromochloromethane (CHClBr2) <0.1 μg/L <0.1 μg/L 

Total Residual Chlorine (TRC) <20 μg Cl/L <20 μg Cl/L 

3.2.6 Based on these results, the Group concurred with the views of the applicant that it was not 

necessary to provide toxicological and eco-toxicological data on these products and that an 

evaluation of the effects of treated ballast water should suffice to provide a recommendation 

regarding Basic Approval. 

3.2.7 However, concern was expressed that the test water used in the application for Basic 

Approval was artificial seawater and so the chemical analysis may not reflect a true 

representation of the effects on natural seawater. 

3.2.8 However, the applicant provided additional information that showed that the artificial 

seawater had been made using tap water that contained 3.5-4 mg/L of dissolved organic 

compounds that made the Total Organic Compounds present at a level of 3.8-4.3 mg/L. 

Furthermore, the tests carried out for Final Approval used treated natural seawater. 

3.2.9 In addition, the applicant provided the following information to explain the reason for the 

very low levels of chemicals produced as by-products by the system: 

Clarification on Wallenius-AOT Chemical Description

The process description presented is based upon the current scientific knowledge about 

photo-catalyses, free radical and marine chemistry cited in the references. Albeit that the 

Wallenius AOT-process generates dichloridyl and dibromidyl radicals in sea water, it 

does not involve any formation of elemental chlorine (Cl2) or Bromine (Br2). Elemental 

chlorine and bromine give rise to environmental stress. This chemistry is not operative in 

the Wallenius AOT-process, and consequently, neither is the associated environmental 

concern. It should be pointed out that the radicals produced in the AOT-treatment unit 

are not different from those naturally formed by sun light in the surface layer of seawater. 

Any potential reaction product that may be formed have been proposed and measured to 

support the chemical process reduction, e.g. the content of chloroform was reduced. 

Most significantly, all biological tests performed have shown that the water treated by the 

Wallenius AOT- process does not display any adverse effect. 

3.2.10 As a result, the Group agreed no significant amount of chemicals were identified in the 

seawater, after treatment with the system, which would require additional toxicological or 

ecotoxicological information to be evaluated. 
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3.2.11 Based on this information, the Group agreed that it was not necessary to evaluate the 

properties of any Active Substance or Relevant Chemical associated with this system. Instead, a 

brief evaluation was carried out on the data generated by testing the treated ballast water, the 

results of which, are shown in the appendix to this annex. 

4 HUMAN HEALTH ASSESSMENT 

4.1 The disinfection principle of AOT/TiO2/UV is based on cellular oxidative stress with 

lysis caused by the generated in situ free radicals and direct photo-effects. These synergistic 

effects are considered sufficiently efficacious to inactivate microorganisms under a certain level 

of concentration/m3. The major modes of reaction will be one-electron transfer (Br2-, CO3-, 

Cl2-, radicals) or addition hydroxyl radicals. 

4.2 Per se, TiO2 is considered non-toxic as shown by its use in reconstructive surgery and Ti 

implants in human clinical care. 

4.3 In the photo-catalytic processes, it is assumed that the formation of bromate, BrO3

-

, a 

known human carcinogenic, is unlikely to occur due to the fact that it would require multiple 

one-electron oxidation steps. Also, the process prevents the production of ozone and its related 

adverse effects. 

4.4 The active free radicals produced in the submitted AOT-treatment unit were dichloridyl 

(Cl2

-

), chlorbromidyl (ClBr-), dibromidyl (Br2

-

) and carbonate (CO3

-

) that have a very short 

half-life (micro- to milliseconds) and therefore transient effects. 

4.5 The by-products of disinfection that were identified and measured were mainly 

chloro- and bromo-organic compounds. From these, especially bromate, chloroform and 

bromoform have a potential for bioaccumulation and human carcinogenicity therefore will have 

to be kept below toxicological critical levels (bromate<10μg/L; bromoform<100μg/L; 

chloroform<200 μg/L, WHO Guidelines for Drinking Water Quality, 2003) or to be removed 

during the ballast water treatment and at discharge. 

4.6 Although the concentrations of these mentioned chemicals were considered to be below 

LOQ, the Group considered that the LOQ was considerably high for the quantification of these 

particular compounds and that the sensitivity of the analytical method could be improved as to 

give satisfactory and conclusive measurements to be able to evaluate human toxicological effects 

produced by the system. 

4.7 Taking into consideration that the current MCL (Maximum Contaminant Level) in US for 

bromate (potassium bromate) is 10μg/L (very close to the LOQ of the analytical method) and the 

maximum contaminant level goal is zero, human exposure should be totally avoided during 

ballast water treatment and at discharge. 

4.8 Additionally, brominated THM compounds are normally volatile liquids at room 

temperature therefore, as chemicals vaporize during water usage, inhalation becomes an 

important exposure route and should be minimized. 

4.9 From the above information it is concluded that the critical health effects resulting from 

human exposure to the active substances and relevant compounds will be related mostly to 
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ANNEX 5 

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respiratory toxicity and carcinogenicity, depending on the severity of exposure and presumably 

under medium and long term scenarios (e.g. occupational exposure). 

4.10 Other factors may be relevant when assessing human exposure towards this group of 

chemicals that include, inter alia: 

 .1 the variability in human individual sensitivity; and 

 .2 the fact that complex mixtures of disinfectants and DBPs, according to the actual 

knowledge, interact in an additive way, at low concentration. 

5 RISKS TO THE SAFETY OF SHIP AND CREW 

5.1 The Group noted that the submission identified the only potential risk to the ship and its 

crew present in the PureBallast system was related to UV irradiation and overheating in the 

treatment unit from the UV lamps. The submission confirmed that these identified risks had been 

addressed by system safety measures that ensure that there is no risk of personnel exposure to 

UV-irradiation and that automatic shut down, in a no flow situation, in order to prevent 

overheating.

5.2 The submission recognises that, concerning ship and personnel safety, the G9 procedures 

require that ìProposed procedures for the use and technical equipment introduced needs to be 

taken into accountî. However neither procedures for use of the treatment system, nor 

confirmation that the equipment is suitable for use on board a ship had been provided for 

evaluation by the Group. It was noted that the submission states that ìThe system has been 

evaluated by Lloyds Classification Society and had been approved with regards to ship and crew 

safetyî, however the Group noted that the referenced approval certificate only relates to 

examination and pressure testing of the system and the connecting piping to the existing ballast 

water system. 

5.2.1 The Group noted that the UV lamps require a ìwarm-upî time before the system is ready 

for use. Full operating and maintenance procedures require to be evaluated to provide all 

necessary considerations for operators and crew safety. 

5.2.2 The Group noted that the electric power requirement of the system will not be an 

insignificant additional ship service demand. It requires to be confirmed that the equipment 

meets all regulatory standards for equipment to be installed on board a ship, both with regard to 

construction and prevention of electric shock to personnel. 

5.2.3 The Group noted that the submission indicated that the corrosivity to the materials or 

equipment of normal ship construction due to possible formation of certain compounds by use of 

the system was to be further investigated. The results of this further investigation should be 

assessed to confirm that any corrosion effect remains acceptable. 

6 ASSESSMENT OF PERSISTENCE (P), BIOACCUMULATION (B) AND 

TOXICITY (T) 

6.1 The Group recognized that is was not possible to evaluate the persistency, 

bioaccumulation and toxicity of any chemicals produced by the system as they were either 
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ANNEX 5 

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short-lived or not detectable. Assessment of the PBT-criteria is therefore considered not 

required. 

7 ENVIRONMENTAL RISK ASSESSMENT

7.1 Derivation of the Predicted No Effect Concentration (PNEC) 

7.1.1 In the dossier for Basic Approval several ecotoxicity tests were available (see section 3.1 

in the appendix to this document). The Group confirmed that the data provided do not indicate a 

potential risk to the environment and agreed that the derivation of a PNEC is not possible as the 

nature of the system does not involve the use of chemicals that make the derivation of a PNEC 

neither possible nor necessary. The Group noted that no effects had been observed during 

chronic toxicity tests, using a100% concentration of treated ballast water. 

7.2 Calculation of the Predicted Environmental Concentration (PEC) 

7.2.1 The Group agreed that there would be no point in calculating the PEC of the treated 

ballast water as it was recognized that a 100% concentration of treated ballast water discharge 

would be acceptable under any situation. 

7.3 Calculation of the PEC/PNEC ratios 

7.3.1 The Group noted that neither the PEC nor the PNEC had been derived. The Group 

agreed that it was not necessary to do so as the PEC/PNEC ratio could be regarded as less than 

one for all practical purposes. 

8 CONCLUSIONS AND RECOMMENDATIONS 

8.1 Risks to the safety of the ship

8.1.1 Subject to the concerns expressed in section 5 and paragraph 0.5 of this annex, the Group 

agreed that this system was not likely to cause any concern with regards to the safety of the ship. 

8.2 Risk to the crew and the general public

8.2.1 It was recognized that the levels of potentially hazardous chemicals produced by this 

system were generally lower than the detection limits of the methods used to analyze for them. 

However, the Group considered that there might still be some human health concerns and so 

agreed that human exposure onboard should be avoided until it can be demonstrated that the 

levels of such chemicals, if produced, are below the threshold limits for any toxicological 

concerns. 

8.3 Risks to the environment

8.3.1 Based on the toxicity tests carried out on the treated ballast water, the Group agreed that 

this system was not likely to cause any concern with regards to the environment. 
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8.4 Conclusions

8.4.1 Having considered all of the data submitted both for Basic Approval and Final Approval 

the Group agreed to recommend to MEPC that Basic Approval be granted to this system and that 

Final Approval also be granted subject to the Administration verifying that the concerns raised 

with regard to ship and crew safety have been fully addressed prior to issuance of a Type 

Approval certificate. 
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Appendix 

BIOLOGICAL PROPERTIES OF TREATED BALLAST WATER 

1 PHYSICOCHEMICAL PROPERTIES

1.1 The Group recognized that it was both unnecessary and irrelevant to report the physical 

properties of treated ballast water. 

2 MAMMALIAN TOXICITY

2.1 The Group noted that the applicant had indicated that, as there were no measurable 

chemical by-products, it was unnecessary to test for: 

 .1 acute toxicity; 

 .2 effects on skin and eyes; 

 .3 chronic and long-term toxicity; 

 .4 development and reproductive toxicity; 

 .5 carcinogenicity; and 

 .6 mutagenicity. 

3 ENVIRONMENTAL EFFECTS 

3.0 Not withstanding the observation noted in paragraph 2.1 of this appendix, the Group 

noted that some aquatic toxicity tests had been carried out using: 

 .1 treated ballast water using artificial seawater (asw); and 

 .2 treated ballast water taken from an Oslo fjord (ofw) at 1m and 60m depth. 

3.1 Acute Aquatic Toxicity Data

3.1.1 The table below summarizes the Groupís evaluation of the acute aquatic toxicity of 

treated ballast water. 

Species LC/EC50 

(mg/l/duration) 

Reference/Comments/Justification 

for missing data 

Fish Scophthalmus 

maximus >100% (ofw) NIVA 5296-2006, section 3.7, p23 

Crustacea Artemia 

franciscana >100%/24h (asw) MEPC 55/2/5 Annex, Appendix 4, p39 

Algae ?? ?? Not needed as chronic toxicity <100% 

Rotifer Brachionus 

plicatilis >100%/48h (asw) MEPC 55/2/5 Annex, Appendix 4, p38 
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3.2 Chronic Aquatic Toxicity Data

3.2.1 The table below summarized the Groupís evaluation of the chronic aquatic toxicity of 

treated ballast water. 

B 

or 

F 

Species LC50(mg/l/duration) 

or 

NOEC(mg/l/duration

Reference/Comments/Justification 

for missing data 

B Scophthalmus 

maximus 

>100%/28d (ofw) 

NOEC (growth test) NIVA 5296-2006, section 3.7, p23 

Fish F 

Scophthalmus 

maximus 

>100% (acute and 

growth test) 

Note: 27% deaths cf 

control of 9% deaths. 

MEPC 56/2/1 Annex, Appendix 4, 

pp. 7 and 20-23 

B Nitocra 

spinipes 

>100%/16d (ofw) 

Reproduction test NIVA 5296-2006, section 3.7, p23 

Crustacea F Nitocra 

spinipes 

>100% (reproduction 

test) 

MEPC 56/2/1 Annex, Appendix 4, 

pp. 7 and 20-23 

B Phaeodactylum 

tricornutum >100%/72h (NOEC) MEPC 55/2/5 Annex, Appendix 4, 

p35 

B Dunaliella 

tertiolecta >100%/72h (NOEC) MEPC 55/2/5 Annex, Appendix 4, 

Algae p36 

F Skeletonema 

costatum >100% (growth 

inhibition) 

MEPC 56/2/1 Annex, Appendix 4, 

pp. 7 and 20-23, test carried after 10 

days of storage, not accepted 

Where: B=data submitted for Basic Approval; and 

 F=data submitted for Final Approval. 

3.3 Information on Endocrine Disruption 

3.3.1 It was noted that the endocrine disruption potential of treated ballast water had not been 

tested for specifically but the applicant reported that juvenile development and reproduction had 

not been affected in the invertebrate test organisms (Brachionus plicatilis) used in the short-term 

toxicity tests (Ref: MEPC 55/2/5, annex, Appendix 4, p.38). 

3.3.2 In addition, the applicant had reported that no potential endocrine disrupting chemicals 

had been identified in the treated water. 

3.3.3 Based on this information, the Group agreed that the treated ballast water was unlikely to 

have any endocrine disrupting effects. 

3.4 Sediment Toxicity 

3.4.1 The Group noted that the applicant had indicated that, based on the chemical analysis and 

toxicity tests of the treated ballast water, there would not be any sediment toxicity associated 

with the treated ballast water. 
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3.5 Bioavailability/Biomagnification/Bioconcentration 

3.5.1 The Group noted that the applicant had indicated that, based on the chemical analysis of 

the treated ballast water, there was no indication of any chemical by-products that might be 

bioaccumulated. 

3.6 Food Web/Population Effects 

3.6.1 The Group noted that the applicant had indicated that, as the full strength treated ballast 

water did not have any measurable effect on any of the test species, it would unlikely for the 

diluted ballast water to have any negative effects on ecological communities at environmentally 

relevant concentrations. 

3.7 Environmental Fate and Behaviour

3.7.1 The Group recognized that the Active Substances produced by the system had very short 

half-lives (micro to milliseconds) and so there was no need to consider their environmental fate 

any further. 

3.7.2 The Group also noted that the applicant had reported that there no detectable by-products 

had been identified following treatment of the artificial seawater with the PureBallast system. 

***

GESAMP-BWWG 3/9 

I:\MEPC\56\2-2.doc 

ANNEX 6 

REVIEW OF PROPOSAL FOR APPROVAL OF ACTIVE SUBSTANCE 

NKO3 Ballast Water Treatment System (NKO3 BWTS) 

(Previously reviewed as Ozone) 

Submitted by the Republic of Korea 

0 SUMMARY 

0.1 The Group noted that the NKO3 System uses ozone as an Active Substance to treat 

ballast water and that the Total Residual Oxidants ((TRO) a mixture of hypobromous acid and 

hypobromite ions), bromate ions and bromoform are resultant by-products of the system when 

used on seawater that are regarded as Relevant Chemicals that needed to be reviewed. Resultant 

by-products and relevant chemicals when used in fresh water ballast situations are not identified 

and information must be provided in the Final Approval application. 

0.2 Having considered the Active Substances and each of the Relevant Chemicals, the Group 

agreed that: 

 .1 due to its very short half-life, ozone (ca 5secs) does not present any environmental 

threat and whilst it is very toxic by inhalation, it should be safe to use providing 

that strict control measures are applied to ensure that human exposure is 

prevented; 

 .2 whilst bromate ions are deemed to be genotoxic/carcinogenic, the environmental 

concentrations produced are well below the Maximum Contaminant Level (MCL) 

(10μg/L) and so are not considered to be a human health risk. In addition, the 

Environmental Risk Assessment indicates that there should be no risk to the 

environment due to the release of this component; 

 .3 bromoform is relatively persistent once released into the environment and is both 

toxic and irritant to mammals. However, due to the low concentrations generated 

by the ozone treatment, it is not considered to be a human health risk. In addition, 

the Environmental Risk Assessment indicates that there should b no risk to the 

environment due to the release of this component; 

 .4 Whilst the level of TRO produced by the system is relatively high, the short half 

life and the lack of any data to suggest that this mixture might be toxic to 

mammals, suggests that this chemical should not be considered to be a human 

health risk. 

0.3 As a result, the Group agreed to recommend that Basic Approval be given to the NKO3 

Ballast Water Treatment System (NKO3 BWTS) submitted by the Republic of Korea. 

0.4 Notwithstanding this recommendation, the Group requested MEPC to note that, in order 

to recommend Final Approval for this system, the applicant would need to provide data on the 

following items: 
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 .1 For Bromate ions: 

 .1.1 acute dermal toxicity data; 

 .1.2 acute inhalation toxicity data; 

 .1.3 acute algal toxicity data; and 

 .1.4 chronic fish, algae and crustacea toxicity data. 

 .2 For Bromoform: 

 .2.1 acute dermal toxicity data; 

 .2.2 acute inhalation toxicity data; 

 .2.3 sensitization data; 

 .2.4 chronic crustacea data; and 

 .2.5 chronic algae data. 

 .3 For TRO: 

.3.1 re-assessment of all acute and chronic mammalian toxicity data if 

available; and 

 .3.2 re-assessment of all chronic aquatic toxicity data. 

1 INTRODUCTION 

1.1 The data for this product were extracted from original data supplied by the Republic of 

Korea to support its submission MEPC 55/2/3 and supplemented by additional information 

identified by the Group. In addition, further information was supplied to the Secretariat of the 

BWWG Working Group following the decision of MEPC 56 not to grant Basic Approval for the 

system due to lack of data. The Group noted that the single point side stream ozone injection 

system that was described in the resubmission documents was different to the diffuser system 

installed on the Tonsina and described in the original description and therefore is another system 

than evaluated as part of the Working Group Report under cover of MEPC 55/2/16. 

1.2 Where more than one value was identified for any of the properties, only those considered 

by the Group to be the most relevant were included in this summary dossier. 

1.3 For the sake of clarity and completeness, this review includes extracts taken from the 

previous review submitted to MEPC 55 as part of the Working Group Report under cover of 

MEPC 55/2/16. 
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2 COMPLETENESS OF THE DOSSIER 

2.1 The Group recalled that information about the following subjects had not been included in 

the initial dossier but had, subsequently, been provided and so allowed an evaluation of the 

system to be carried out: 

 .1 quality control/quality assurance programme implemented in the testing process of 

the Ballast Water Management System; 

 .2 an overview of the ballast water management system (BWMS) with description of 

the components of the system; 

 .3 the planned dosage of ozone to be injected into the ballast water and applied in 

several of the experiments presented in the dossier. This information was later 

provided by request from the Group in a meeting with technical experts from the 

applicant and in an email dated 25 May 2006, as well as being included in the 

supplementary data provided to the GESAMP-BWWG Secretariat post MEPC 55; 

 .4 how ozone will be injected into the ballast water pipe; 

 .5 safety considerations regarding the presence of free ozone in the ballast tanks; and 

 .6 a consideration of the corrosive implications arising from the use of ozone. 

However, supporting data were not provided in the dossier. 

2.2 It was noted that the dossier states that the reaction between ozone and bromide in the 

seawater produces bromate ion, tribromomethane (bromoform) and TRO (hypobromite ion / 

hypobromous acid) and the ratio of such reaction products varies with pH and organic loading. 

The dossier did include some data about bromoform concentrations after ozone treatment, but 

the Group noted that this information was from the initial installation using multipoint injection 

that was the former version of the system and are therefore in need for confirmation of 

relevancy. 

2.3 It was noted that the dossier did not include information about other relevant halogenated 

chemicals that may be produced according to open available literature and the dossier itself. The 

Group therefore recommends that additional analysis is included in the further testing onboard 

ships and in land based tests and that these data are submitted in the application for final 

approval. The Level of Quantification (LOQ) of the analytical methods used for the potential byproducts measured should be at a level that confirms that the potential amount of by-products 

produced by the system is sufficiently low and meets the international standards on these 

substances. The Group considers the LOQs used to be too high. It is common to determine these 

contaminants in surface waters at levels of 0.01 ñ 0.05 μg/L. 

3 DESCRIPTION OF NKO3 BWTS (Ballast Water Treatment System) 

3.1 Overview of the system 

3.1.1 The Group noted that the NKO3 BWTS treats ballast water by injecting ozone into the 

ballast water utilising a novel single point injection system and consists of: 
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 .1 a system for generating ozone onboard; 

 .2 a ballast water injection and control system; and 

 .3 an ozone gas destruct unit for use when testing and purging the ozone generator. 

3.1.2 In addition, it was noted that full-scale tests following extensive laboratory and pilot-scale 

testing had been carried out. The submission indicates that initial full scale tests had been carried 

out with ozone utilising a multi point ozone injection system on one tanker, and that a single 

point injection systems has now been installed on another tanker for further development and 

testing of the NKO3 BWTS. The test procedures include parallel tests with untreated ballast 

water for control to be undertaken. The Group noted that the data presented for evaluation mainly 

originated from the multipoint injection system. 

3.1.3 The Group noted that the applicant had provided in the submission a full description of 

the system including: 

 .1 a general description of the NKO3 BWTS; 

 .2 a description of the single point side stream ozone injection system; 

 .3 a general operating and maintenance manual for the ozone generation unit; 

 .4 a description of the control philosophy for the ozone generation system; 

 .5 a safety manual for an ozone system; 

 .6 installation guidance and plans; 

 .7 piping, instrumentation and assembly drawings; and 

 .8 data sheets for system components. 

3.1.4 The Group noted that the single point side stream ozone injection system that was 

described in the resubmission documents was different to the diffuser system tested in the 

original description. 

3.1.5 The Group noted that the applicant had indicated that this new system mixed the ozone 

more efficiently than the original diffuser system, which meant that less ozone was required and, 

therefore a smaller amount of the Relevant Chemicals would be generated. 

3.1.6 Having considered the additional information provided, the Group agreed that it satisfied 

the concerns expressed about the lack of systems data that had been expressed at its previous 

meeting and the information provided now enabled the appropriate evaluation required for basic 

approval to be performed. 

3.2 Active Substances, Relevant Chemicals and Other Chemicals 

3.2.1 The Group noted that the only Active Substance used in this BWMS is ozone that 

is generated onboard. The submission indicates that it is the intention to dose ozone at the rate 
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of 1-2 mg/L ballast water although there is other information giving the maximum concentration 

injected as being 2.5 mg/L. 

3.2.2 Whilst recognizing that ozone is routinely used to disinfect drinking water; when it is 

injected into seawater, the following Relevant Chemicals will be formed due to the presence of 

bromide ions that are not present in drinking water: 

 .1 bromate ion (BrO3

-

) is produced from the reaction of ozone with bromides in 

seawater. It will be found as an equilibrium between bromate ion, hypobromous 

acid and sodium bromate; 

 .2 bromoform (CHBr3) is produced from the reaction of ozone with naturally 

occurring organic matter in water used for ballast; and 

 .3 hypobromous acid (HOBr)/hypobromite ion (OBr-

) that, together are referred to as 

Total Residual Oxidant (TRO). 

3.2.3 .Several other by-products have been reported in the dossier and in open literature from 

the reactions between organic matter and TRO. 

3.2.4 The following table provides information on the identity of the Active Substance and 

Relevant Chemicals. 

 Table Identification on the Active Substance 

Chemical name CAS 

number 

(UN 

number) 

Molar 

mass 

Empirical 

formula 

Structural 

formula 

Max. initial 

concentration 

anticipated in 

ballast water 

Ozone 10028-15-6 

(1956) 48.00 O3 1-2.5 mg/L 

Hydrogen 

hypobromite 13517-11-8 96.91 HOBr HO-Br 

Hypobromate 

ion 

TRO 

 OBr- O-Br7.5 mg/L 

Bromoform 75-25-2 

(2515) 252.7 CHBr3 0.1-0.25 mg/L 

Bromate ion 15541-45-4 127.9 BrO3

- < 2 μg/L 

3.2.5 The Group noted the following chemical reactions associated with the treatment of ballast 

water with ozone by the proposed system: 
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O3 + Br- O2 + OBr- k = 160 ± 20 M-1s

-1

O2 + 2OBr- 2O2 + 2Br- k = 330 ± 60 M-1s

-1

OBr- + H3O+ HOBr + H2O k = 2.09 109 M-1s

-1

HOBr + H2O OBr- + H3O+ pKa = 8.8 ~ 9.0 

2O3 +OBr- 2O2 + BrO3

-

 k = 100 ± 20 M-1s

-1

HOBr + NH3 NH2Br + H2O k = 7.5 107

 M-1s

-1 

where O3 and OBr-

 are considered the real actives and k is the reaction rate constant. 

In Figure F1 these main reactions of the chemistry of ozone are depicted. 

Figure F1 Main reaction scheme for ozone. NOM: Natural Organic Matter 

3.2.6 The Group noted that a normal operation procedure would result in an initial 

concentration of between 1 and 2.5 mg O3/L. It was also noted that this was the anticipated 

concentration prior to ozone performing its disinfecting activity and that the applicant had 

indicated that the concentration of ozone released from the tank would be close to zero. 

However, as ozone will constitute around 12% by weight of the total gas injected into the ballast 

water line, total gas quantities injected can be calculated as 15 mg/L. It can be anticipated that 

some of the ozone will not be dissolved and that some of the injected gas will be released into the 

ballast tanks from which it will be ventilated. 

3.2.7 In addition, it was noted that ozone interacts with naturally occurring bromide ions 

(hypobromous acid/hypobromite ion) to produce very low quantities of bromoform and bromate 

ion together with other halogenated compounds. These bromide ions break down slowly in the 

dark (half life of 1-2d) but react quicker with sea water under the influence of UV radiation. 

3.2.7 The Group concluded that the main components to take into account for the risk 

assessment would be bromate, Total Residual Oxidants (TRO), bromoform and other 

halogenated compounds. 
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3.2.8 Details of the evaluation of each chemical employed or generated by this system are 

shown in the appendices as indicated below: 

 .1 Ozone Appendix 1 

 .2 Bromate ions Appendix 2 

 .3 Bromoform Appendix 3 

 .4 TRO Appendix 4 

3.2.9 However, having received additional information related to the application of ozone via 

the Side Stream Injection System, rather than the original diffuser system used, the Group agreed 

that, whilst the chemicals identified in paragraph 3.2.8 could be formed in sufficient amounts to 

warrant detailed evaluation: 

 .1 the amount of bromate ion produced was less than the detection limit (<2μg/L); 

 .2 the amount of bromoform formed reached the maximum of 255 μg/L; and 

 .3 whilst the amount of TRO (measured as Br-) produced is about 7.5 mg/L, 

at discharge, this level is expected to drop to about 1.2 mg/L after 

approximately 12 hours holding time in ballast tanks. 

3.2.10 The Group took these new facts into account when evaluating this system. 

3.2.11 In addition, the Group agreed that the different methods of applying the Active 

Substance (Ozone), which resulted in differing amounts of by-products emphasized the need for 

the Group to evaluate the risks associated with the whole system rather than limiting the analysis 

to the chemicals involved. 

4 HUMAN HEALTH ASSESSMENT

4.1 Taking into consideration the concentrations of Active Substance and Relevant Chemicals 

associated with the disinfection process described in the republic of Koreaís Application Dossier, 

the Group was able to reach the following conclusions: 

.1 Ozone is very toxic by inhalation as well as being irritant to eyes. Whilst not 

being classified as a carcinogen, there are concerns about its mutagenic potential. 

 As a result strict mitigation measures should be applied to avoid human inhalation 

exposure during the process. 

 .2 Bromate (potassium bromate): exhibits a high potential for 

mutagenicity/carcinogenicity in humans. The current MCL (Maximum 

Contaminant Level) in the United States is 10μg/L and the maximum contaminant 

level goal is zero, because of the possibility that bromate may be a genotoxic 

carcinogen. Although <2 μg/L (limit of detection) of bromate ions were detected 

in the treated ballast water, the Group considered that the risks to humans health 

could be of concern and therefore risk mitigation measures should be put in place 

in order to minimise occupational exposure. 

 
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.2.1 It was noted that the applicant claimed that there would be no threat to 

human health from bromate ions unless they are ingested. It was also 

noted that the applicant had indicated that any ballast tank would be 

emptied and fully ventilated before the crew were allowed to enter under 

normal circumstances. As a result, the applicant claimed that there was no 

risk of inhalation or ingestion of treated ballast water. 

.2.2 However, the Group recognized that, apart from the crew, members of the 

public need to be taken into consideration as exposure could occur both by 

ingestion and inhalation when swimming in the sea. In this context, it was 

noted that the U.S.EPA regulate the level of bromate in drinking water 

to 10 μg/L (WHO Guidelines for Drinking water Quality, 2003) and a 

lower level in swimming pools. 

 

 .3 Bromoform is toxic both by oral ingestion and inhalation as well as being irritant 

to skin, eyes and the respiratory tract. EPA classified bromoform as a probable 

human carcinogen, group B2 (EPA, 2005). The primary routes of exposure are 

ingestion and inhalation (from volatized compounds) and dermal exposure during 

bathing. Bromoform is readily absorbed from GIT and may be absorbed through 

the respiratory tract and skin. They are rapidly distributed throughout the body. 

Principal health effects associated with inhalation or oral exposure to bromoform 

are central nervous system depression and liver and kidney damage. 

.3.1 There is strong evidence that the hepatotoxicity of bromoform is due to its 

metabolism into reactive intermediates and highly reactive trihalomethyl 

free radicals. 

.3.2 Oral MRL (Minimal Risk Levels) have been derived for: 

- acute-duration oral exposure (14 days or less).of 0.7 mg/kg/day; 

- intermediate-duration exposure (15-364 days) of 0.2 mg/kg/day; 

- chronic-duration exposure (365 days or more) of 0.02 mg/kg/day. 

As a result, human exposure to this compound must be kept under critical 

toxicological levels. 

.3.3 Taking into consideration the relevant toxic effects and the concentration 

measured in the treated ballast water (max. 0.255mg/L), the Group 

considered that bromoform represents a potential risk for human health in 

case of oral and inhalation exposure and therefore, the system should be 

optimized. 

4.2 Other relevant factors that have to be taken into account when assessing human exposure 

towards chemicals include: 

 .1 the variability in individual sensitivity (e.g. genetic polymorphism); and 

 .2 the fact that complex mixtures of disinfectants and DBPs interact in an additive 

way, at low concentrations (EHC 216, WHO, 2000). As a result, there is an 

additional concern regarding the potential for cumulative toxicological effects of 

the mixture of chemicals generated by the system proposed by this application. 
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5 RISKS TO THE SAFETY OF THE SHIP, ITS CREW AND THE GENERAL 

PUBLIC 

5.1 The Group recalled that, during the first review of this application, it had been noted that 

only generic safety requirements required for an ozone system had been described and that no 

indication had been given on how these requirements were to be applied when such a system 

would be used onboard a ship. The present submission is recognised to address the previous 

concerns raised with regards to system information. 

5.2 It was also noted that the present submission indicates that the prototype system did 

develop ozone leaks at several locations and instances over the test period. It was reported that at 

times the odour of ozone was noticeable at certain locations on deck and in a control room. 

5.3 The Group recognised the potential for risk to the health of the crew arising from the 

possibility of exposure to ozone from system leakage. However, the Group noted that the 

submission acknowledges this risk and identifies onboard risk control measures that will reduce 

the possibility of personnel exposure to ozone if plant leakages should occur. The submission 

indicates that the system will be protected by ozone gas detectors that will shut down ozone 

generators should the ozone in the working environment exceed set limits. The ambient ozone 

alarm set points are advised as 0.1 ppmv for alarm and 0.3 ppmv for equipment shut down 

respectively. It was noted that the ozone safety manual presented recommends shut down at a 

level of 0.2 ppmv, and the Group therefore considers that the recommendation should be 

followed. 

5.4 The Group noted that the submission states that the improved ozone injection technology 

provides a high level of the ozone entering into solution, and that ozone has a half life of 5.8 

seconds when in solution. The Group still has some concern that gaseous ozone will enter the 

ballast tank with a consequential risk of personnel exposure, particularly in the area of the tank 

air vent during filling of a ballast tank, and recommends safety procedures to be put in place to 

counter such risk until it can be verified no such risk is raised. 

5.5 With regard to missing information, identified in the previous evaluation, related to any 

corrosion potential to the shipsí materials of construction that might exist, the Group noted that 

the applicant had, now, reported test results that showed that ozone treated ballast water does not 

increase the rate of corrosion. Indeed, ozone decreases the rate of corrosion by killing those 

micro-organisms that secrete corrosive acids. The Group recommends that the positive test 

results referred are verified in practice. 

5.6 The Group noted that the submission states that crew will never enter a tank prior to the 

tank being fully ventilated and dried. This is unfortunately not the case in practice as it is nearly 

impossible to ensure a tank being dry, and the ventilation must also be basic due to tank design 

and the fact that there are very few ballast tanks with dedicated mechanical ventilation, if any, 

consequently there will always be some water content no matter how efficient the drainage 

arrangements with high humidity conditions within the tank. The submission identifies a 

potential for brominated trihalomethanes to be present in the treated ballast water as a 

consequence to the process, and indicates that further risk assessment will be performed during 

the ongoing approval procedure. The Group agrees this potential risk to crew health to be in 

need of further consideration and testing to provide confirmation that the potential risk level will 

remain acceptable in all cases. 
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5.7 As a result, the Group considered that, from the ship and crew safety perspective provided 

the above recommendations are taken into account the system may be recommended for Basic 

Approval. 

6 ASSESSMENT OF PERSISTENCE (P), BIOACCUMULATION (B) AND 

TOXICITY (T) 

6.1 Three products were identified as being relevant to assess for their Persistence (P), 

Bioaccumulation potential (B) and their Toxicity (T). The assessment of these products is shown 

below: 

Compound Persistence (P) 

Half life: 

>60d in seawater 

>40d in freshwater 

>180d in sea sediment 

>120d in fw sediment 

Bioaccumulation (B) 

Log Pow >3 

Toxicity (T) 

Chronic NOEC<0.01 mg/L 

Ozone No

(Half life=5.8 sec) 

No

(Log Pow=-0.87) No 

Bromate ion No? No

(Log Pow=0.63) No 

Bromoform 

Yes

(Half life 340d in 

sediment) 

No 

(Log Pow=2.4&BCF=14) 

No

(4.8 mg/L) 

6.2 The Group agreed that, although no information was available on the B-characteristics of 

ozone and bromate ion it was not expected that any of these substances would meet the criteria 

and therefore none of these substances should be classified as a PBT substance. 

Along with other brominated DBPs, bromoform is highly stable compound and capable of 

bioaccumulating. As a result, exposure to these on the long-term should be minimized. 

7 ASSESSMENT OF TREATED BALLAST WATER 

7.1 The Group noted that experiments to determine the concentrations of Active Substances 

(Ozone) and Relevant Chemicals (Bromate ions and Bromoform) yielded the following results: 

Concentration 

(mg/L) 

Ozone 2.5 at time zero 

Total Residual Oxidant (TRO) 7.5 

Bromate ion <0.002 (Detection Limit) 

Bromoform 0.255 (max. observed) 

7.2 From these data the group concludes that the maximum concentration relevant for the 

environment would be TRO and bromoform. The concentration for TRO of 7.5 mg/L and for 

bromoform 0.255 mg/L would be relevant to take into account for further exposure of the aquatic 

environment. 
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7.3 In this context, it was noted that the applicant was proposing to install a ferrous 

ion/charcoal system to eliminate any concern associated with the short-term toxicity due to TRO 

and bromoform in the discharged ballast water. 

8 ENVIRONMENTAL RISK ASSESSMENT 

 The Group noted that the half-life for ozone in seawater was reported as only 5.8s in 

seawater and 30 min in freshwater and so would be degraded prior to being released into the 

marine environment. 

8.1 Derivation of a Predicted No Effect Concentration (PNEC) 

8.1.1 TRO: As only acute toxicity data were available the PNEC will be derived by an 

assessment factor of 1000 on the lowest value: PNEC = 0.08 μg/L as TRO. 

8.1.2 Bromate: As there appeared to be a discrepancy between the data submitted by this 

applicant and that submitted by another applicant, the Group decided to use those values 

calculated for the other submission. 

8.1.3 Bromoform: As for bromoform there is one chronic value available. An assessment 

factor of 100 is applied to this value resulting in a PNECchronic = 48 μg/L and 3 acute data, the 

lowest of which is 7.1 mg/L. Using an assessment factor of 1000 the PNECacute is established at 

7.1 μg/L. Of these two data the lowest value is taken as the resulting PNEC: PNEC = 7.1 μg/L as 

bromoform. 

8.2 Calculation of the Predicted Environmental Concentration (PEC) for the Active 

Substance and Relevant Chemicals

8.2.1 The Group noted that the applicant had used the MAM-PEC model to generate PECs in 

the harbours of Busan and Rotterdam for the various chemicals associated with the NKO3 

BWTS. 

8.2.2 It was also noted that the model had been applied to three different areas in the port of 

Busan that the applicant had considered to represent: 

 .1 a marina; 

 .2 a commercial harbour; and 

 .3 the open sea. 

8.2.3 It was agreed that, due to the short half-life of ozone, it was not necessary to model this 

product. Whilst various result were produced for the different scenarios, the Group noted that the 

applicant had used a worst case scenario using the port of Busan and initial concentrations are 

shown in the table below. The Group recognized that emission concentrations of bromoform 

should be changed to 255 μg/L according to 3.2.4 for a worst case scenario. and that this initial 

condition, the PEC should be almost doubled. 
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Chemical Emission Concentration Predicted Environmental 

Concentration (PEC) 

TRO at least 5000 μg/L at least 0.071 μg/L 

Bromate 2 μg/L 0.003 μg/L 

Bromoform 136 μg/L 0.276 μg/L 

8.3 Calculation of PEC/PNEC ratios

8.3.1 Using the results from the environmental modelling and the estimated PNEC values 

obtained from aquatic toxicity testing, the Group agreed on the following PEC/PNEC ratios for 

those chemicals associated with this system. 

Chemical PEC 

(μg/L) 

Toxicity 

(μg/L) 

Factor 

Applied 

PNEC 

(μg/L) 

PEC/PNEC 

TRO 0.071 80 (Acute) 1000 at least 0.08 at least 0.89 

Bromate 0.003 30000 (Acute) 1000 30 0.0001 

Bromoform 0.276 710 (Acute) 1000 0.71 0.39 

8.3.2 The Group noted that even minor changes in the PEC or PNEC concentration could cause 

the PEC/PNEC ratio to rise above 1 in both TRO and bromoform, and that this gives cause for 

concern as risk might be identified. 

9 CONCLUSIONS AND RECOMMENDATIONS 

9.1 Risks to the safety of the ship

9.1.1 The Group agreed that the risk to the environment, including the atmosphere, related to 

the presence of TRO, bromoform and other halogenated organic compound should be further 

assessed as part of the development of the system and that the amounts reported in this 

application should be confirmed in any further submission. 

9.2 Risks to the crew and general public

9.2.1 The Group agreed that the formation of bromate, bromoform and other halogenated 

organic compounds as Relevant Chemical may give rise to human health concerns if present at 

critical toxicological levels. The Group noted that the applicant had indicated that the level of 

such chemicals generated by the system were lower than would be of concern. However, the 

Group remained concerned that the levels of such compounds generated may exceed normally 

accepted safe levels in practice. It was agreed that these levels should be monitored and safety 

measures applied until in can be shown that exposure to such levels is safe. 

9.2.2 In this context, the Group wished to emphasize the points made in section 5 of this report. 

9.3 Risks to the environment

9.3.1 The Group recognized that the environmental exposure to the Active Substance ozone is 

very limited as the substance will react with organic matter and therefore degrades rapidly. 

Possibly remaining total residual oxidant (TRO) may still be present in concentrations that could 
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cause environmental concern. In recalling its concerns expressed in paragraph 8.3.2 of this 

report, the Group agreed that a more thorough Risk Assessment would be required in order to if 

such concerns were to be reduced. 

9.3.2 The Group suggested that MEPC invites the submitting Administration to ensure that all 

the above conditions are taken into account and appropriate measures are put in place during 

further development and testing of the NKO3 system. 

9.4 Conclusions

9.4.1 Whilst recommending that Basic Approval be granted to this system, the Group agreed 

that it would be necessary for the applicant to complete the data forms shown in the appendices 

to this report, for each of the chemicals produced by this system unless appropriate scientific 

reasons can be provided for not doing so. 

* * * 
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Appendix 1 

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF OZONE 

1 PHYSICOCHEMICAL PROPERTIES 

1.1 The following table (A1T1) shows the properties of the Active Substance (Ozone). 

Table A1T1: Physicochemical properties of Active Substances and Relevant Chemicals 

Physical property Ozone 

CAS number 10028-15-6 

Molecule weight 48 

Melting point (°C) -192.7 

Boiling point (°C) -111.9 

Flash point Non-flammable 

Density (kg/m3) @ -183 °C 1.5 

Vapour pressure (Pa) @ 20°C 167000 

Vapour density (air=1) 1.65 

Water solubility (g/L) 0.003 

pH in solution Not Required 

Octanol / water partition coefficient (log Pow) -0.87 

Dissociation constant(pKa) Not Available 

Oxidation reduction potential (V) 2.07 Eo

Corrosivity to Material Yes 

Reactivity to container material Reacts with any material liable to 

oxidize 

Auto ignition temperature (°C) Non-flammable 

Explosive Properties Explosive when heated or in contact 

with combustible material 

Oxidizing properties Powerful oxidiser 

Surface tension (dyne/cm) 48.4 

Viscosity (cp) @ -183°C 1.55 

Thermal stability and breakdown product Thermal oxidative decomposition will 

produce oxygen 

Other physical and Chemical property Bluish gas with characteristic odour 

2 MAMMALIAN TOXICITY

2.1 Acute mammalian Toxicity

2.1.1 The following table summarizes the acute mammalian toxicity data identified by the 

Group. 

Exposure route Value Species Reference/Comments/Justification 

 for missing data 

Oral LD50 (mg/kg) n/a n/a 

Dermal LD50

(mg/kg)

n/a n/a 

It was recognized that it is not possible to 

determine oral and dermal toxicities for gases 

Inhalation LC50

(mg/l/4h) 

0.012 Mouse Cheminfo by CCOHS (Canadian Centre for 

Occupational Health and Safety) 
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2.1.2 The selected inhalation value was taken from a range of values from which the lowest 

value for a 4h exposure was taken. 

2.2 Corrosion/Irritation

2.2.1 The following table summarizes the mammalian corrosion and irritation data identified by 

the Group. 

 Species Method Observation 

(including 

scores where 

available) 

Reference/Comments/Justification 

for missing data

Skin Not irritant EHP (1990) 

Eyes Human Irritant 

(>0.4mg/L for 

several minutes) 

EHP (1990) 

Respiratory 

tract 

Human Coughing and/or 

breathing 

difficulties at 

0.3-1.2μg/L 

MSDS provide by applicant 

2.2.2 The Group noted that from the submitted information and several studies in humans 

mentioned in the literature (EHC 216, 2000), the group concluded that even very low doses of 

ozone can be harmful to the upper respiratory tract and the lungs. In addition, there seems to 

exist synergetical effects, as exposure to very low concentrations initially increases reactivity of 

the airways to other inhaled substances (bronchial hyperresponsiveness) and cause inflammatory 

response in the respiratory tissue. Other symptoms observed following acute exposure to 0.5-

1.5μg/L include cough, shortness of breath, tightness of the chest, dyspnea, headache and nausea. 

More severe symptoms have been observed following concentrations higher than 0.02mg/L that 

included reduce lung function, extreme fatigue, dizziness, inability to sleep and cyanosis. An 

acute occupational exposure to approximately to 0.022mg/L caused severe respiratory irritation 

and almost caused unconsciousness. A 30 min exposure to 0.1 mg/L is considered potentially 

lethal. 

2.2.3 The Group agreed that, based on applicantís submitted information (EHS, 1990), ozone 

seems not to cause any adverse effect on the skin but is irritating to the eyes when exposed to 

4mg/L for several minutes. Other information (CCOHS) indicates that ozone gas can probably 

cause skin irritation due to its oxidizing ability, but only at concentrations capable of causing 

severe respiratory injury. 

2.3 Sensitization 

2.3.1 The Group recognized that standard skin sensitization tests are not possible for gases and 

so there were no laboratory data available for this property. It was also noted that there are no 

data to suggest that ozone might be a sensitizer and it is not classified as such by the EEC. 

2.4 Repeated-Dose Toxicity

2.4.1 From the available information, it was not possible to address the dose-response effects in 

relation to repeated inhalation exposure (sub-chronic, 90 days) to ozone. However, the Group 
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considered that similar effects on the lungs of humans and other mammals even at low 

concentrations. In addition, it is referred in literature that the severity of respiratory responses 

seem to be reduced following repeated daily exposures due to an apparently ìfunctional 

adaptationî. 

2.4.2 The Group noted that long-term occupational exposures to ozone have resulted in 

headaches, irritation of the nose and throat, chest constriction and lung congestion in exposed 

workers. Human population studies indicate that people living in communities with high 

background ozone levels have experience a greater decrease in lung function over five years than 

people living in communities with lower background levels. These studies suggest that longterm exposures to ozone may result in impaired lung function and are consistent with animal 

studies that have shown that such exposures can impair lung function and cause structural 

changes to the lungs. 

2.5 Chronic and long-term toxicity

2.5.1 The Group noted that, in a series of well conducted studies, mice and rats exposed 

to 0.01-0.02mg/kg bw/day for 105 to 130 weeks had increased incidence of non-carcinogenic 

lesions of the nose and lungs (NTP, 1994). Several studies also examined the effects of 

the long-term effects on monkeys. Exposures ranging from 0.003-0.013mg/kg bw/day 

for 3-18 months consistently showed significant structural alterations to lungs. Many of them 

seem to be irreversible six months after exposure stopped (COSHH). 

2.5.2 In addition, the Group noted that studies in humans examining the potential effects of 

long-term occupational exposures to ozone had reported headaches, irritation to nose and throat, 

chest constriction and lung congestion in exposed workers. These studies suggest that long-term 

exposures to ozone may result in impaired lung function that is consistent with the results of 

animal studies. 

2.6 Development and Reproductive Toxicity

Inhalation 

Exposure Duration (1) 4 days in middle or late pregnancy 

(2) 7-17 pregnancy 

(3) ? 

(4) 6 days prior to mating to postnatal day 22 

Exposure dose (1) 0.02; 0.03mg/kg 

(2) 0.024 

(3) and (4) dose not referred 

Species (1) rat 

(2) Mouse 

(3) rat 

(4) Mouse 

Method 
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Results (1) observed adverse effects: reduced growth rates after birth and 

delayed behavioural development; no maternal toxicity 

(2) observed adverse effects: decrease of fetal body weight gain; 

maternal toxicity 

(3) observe adverse effects: embriotoxicity (increased resorptions; 

no maternal toxicity 

(4) observe adverse effects: reduced body weight and slight effects 

in neurobehaviour development of the offspring; maternal tox. 

not evaluated 

NOAEL (1) not referred 

(2) 0.016mg/kg /day 

(3) 0.013mg/kg /day 

(4) not referred 

NOEL 

Reference/Comments/ 

Justification for missing 

data 

2.6.1 A study reported offspring of rats continuously exposed to 0.02 or 0.03mg/kg bw for four 

days during middle or late pregnancy had reduced growth rates after birth and delayed 

behavioural development. Maternal toxicity was not reported. 

2.6.2 A study reported offspring of rats continuously exposed to 0.02 or 0.03mg/kg bw for four 

days during middle or late pregnancy had reduced growth rates after birth and delayed 

behavioural development. Maternal toxicity was not reported. 

2.6.3 Another study reported a decrease in foetal body weight gain in the offspring of mice 

exposed to 0.024 but not to 0.008 or 0.016mg/kg bw, on days 7-17 of pregnancy. Signs of 

maternal toxicity were observed (Tox. Applied Pharmac.,1979). 

2.6.4 Embryotoxicity (increased resorptions) was observed in rats exposed to 0.03 

and 0.04mg/kg bw, but not 0.013-0.025mg/kg bw. Maternal toxicity was not reported (COSHH). 

2.6.5 Continuous exposure of mice from six days prior to mating to postnatal day 22 resulted in 

reduced body weight and slight effects in neurobehaviour development of the offspring. 

Maternal toxicity was not evaluated (Arch.Toxicology, 1995). 

2.6.6 No effects on reproductive performance (proportion of successful pregnancies, litter size, 

offspring viability and sex ratio) were noted in mice exposed for six days prior to mating to 

postnatal day 22 (dose was not referred) (Arch.Toxicology, 1995). 

2.6.7 Pups from pregnant rats, exposed to 1.0 and 1.5 μ/L during mid gestation or late gestation 

showed transiently reduced neonatal growth rates. The pups delivered from dams exposed during 

late gestation showed retardation in early reflex development and in open field behaviour. 

Similarly exposed males remained permanently stunted in growth. (Tox Letters, 5 (1990) 3-9. 
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2.7 Carcinogenicity/Mutagenicity

 Species Method Details Results 

(Yes/No) 

Reference/Commen

ts/ Justification for 

missing data 

Carcinogenicity Rat and 

Mouse 

Lifetime 

inhalation 

exposure to0.12-

1.0μ/L 

No evidence for 

carcinogenicity 

Mutagenicity Salmonella 

typhimurium; 

lymphocytes 

of hamsters; 

rats 

macrophages 

With and without 

S9 metabolic 

activation 

Yes, there is 

evidence for 

mutagenicity in 

bacteria an 

animal cells 

National Toxicology 

Program Technical 

report series No. 440 

2.7.1 From a study with rats and mice exposed to 0.0024, 0.01 and 0.02mg/kg bw of ozone for 

105 to 130 weeks, there was no evidence for carcinogenicity in male and female rats, 

inconclusive evidence in male mice, and some evidence in female mice. Ozone did not have 

tumour promoter properties (NTP, 1994). 

2.7.2 However, the Group noted that positive results (cytogenetic aberrations) were observed in 

the lymphocytes of hamsters exposed to 0.0048-0.086mg/kg bw for 5 hours and in the lung 

macrophages of female rats exposed to 0.0024-0.016mg/kg bw for 6 hours. However, several 

studies have shown that ozone is mutagenic in bacteria and in mammalian and human cells 

in vitro following inhalation exposure (NTP, 1994; Mutation Research, 1992). 

2.7.3 The American Conference of Governmental Industrial Hygienists (ACGIH) has 

designated this chemical as not classifiable as a human carcinogen (A4). 

2.8 Toxicokinetics

2.8.1 Ozone is absorbed in both the upper and lower respiratory tract. It is a potent oxidant that 

reacts with protein and lipids, particularly within biological membranes. A small amount of 

inhaled ozone is absorbed into the blood. The extreme reactivity of ozone limits its ability to 

accumulate. 

2.9 Human health hazards

2.9.1 The Group noted that Ozone is very toxic by inhalation route and therefore apply strict 

mitigation measures should be applied to avoid human inhalation exposure during the process. 

2.9.2 In addition, by exposure and due to its oxidant properties, there may be a concern towards 

ozone potential for mutagenicity. 

2.9.2 From submitted information and several studies in humans mentioned in literature 

(EHC 216, 2000), the Group concluded that even very low doses of ozone can be harmful to the 

upper respiratory tract and the lungs. 
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3 ENVIRONMENTAL EFFECTS AND FATE

3.1 Acute Aquatic Toxicity 

3.1.1 The Group recognized that ozone has a very short life in water (<5 secs) and so its acute 

and chronic toxicities cannot be measured. However, as indicated by the applicant and shown in 

the section on fate and behaviour, the ozone reacts with components of water to produce other 

oxidants, described as Total Residual Oxidants (TRO) that have an overall effect on the aquatic 

organisms. 

3.1.2 The following table shows the acute toxicity of ozone treated water that is effectively the 

acute toxicity of TRO in water. 

F 

C 

A 

Species Effect Value 

F Morone americana 96-h LC50 0.20 mg/L as TRO 

C Daphnia magna 48-h LC50 0.011 mg/L 

C Americamysis bahia 96-h LC50 24.4 mg/L 

A Nannochloris sp. 72-h EbgCx <0.45 mg/L as TRO 

A Skeletonema costatum 168-h IC50 32 mg/L 

F=Fish, C=Crustacea, A=Algae 

3.2 Chronic Aquatic Toxicity

3.2.1 The Group agreed that, because of its short half-life, it was not possible to provide any 

data on the chronic aquatic toxicity of ozone. 

3.3 Information on Endocrine Disruption

3.3.1 The Group agreed that, because of its short half-life, it was not possible to provide any 

data on the endocrine disruption potential of ozone. 

3.4 Sediment Toxicity 

4.4.1 The Group recognized that, due to the very short half-life of ozone, it was not possible to 

generate any sediment toxicity data for this chemical. 

3.5 Bioavailability/Biomagnification/Bioconcentration 

4.5.1 The Group recognized that, due to the very short half-life of ozone, it was not possible to 

generate any bioavailability/biomagnification/bioconcentration data for this chemical. 

3.6 Food web/Population Effects 

3.6.1 The Group recognized that, due to the very short half-life of ozone, it would not have any 

adverse effect on the ecological communities. 
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3.7 Environmental Fate and Behaviour 

3.7.1 An overview of the fate processes for ozone are presented in the following table: 

Property Ozone 

Hydrolysis 

pH5 (seawater) ≤5 sec 

pH7 (seawater) ≤5 sec 

pH9 (seawater) ≤5 sec 

Photolysis NA 

Degradation in seawater NA 

Ready biodegradation 1 h 

Biodegradation NA 

Sorption (Koc) NA 

Bioconcentration - 0.87 

Anaerobic degradation NA 

 NA = not available 

3.7.2 Although in the table several items are marked ìnot availableî the Group is of the opinion 

that additional information on these items is not considered necessary because of the very low 

half life in the environment (ca. 5 sec). 

3.7.3 Therefore it is expected that the Predicted Environmental Concentration (PEC) was 

assumed to be close to zero or the same as any naturally occurring ozone. 

3.7.4 The Group agreed that as a result, the PEC/PNEC ratio was assumed to be <<1 and as it 

was not defined as a PBT, the ozone itself would not present an environmental risk. 

* * * 
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Appendix 2 

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF BROMATE ION 

1 PHYSICOCHEMICAL PROPERTIES

1.1 The following table show the properties of the Relevant Substance (Bromate ion) in the 

form of sodium bromate and potassium bromate. 

Physical property Sodium 

bromate 

Potassium 

bromate 

CAS number 7789-38-0 7758-01-2 

Molecule weight 150.90 167.01 

Melting point (°C) 381 350 

Boiling point (°C) NA At 370°C 

decomposes 

Flash point NA NA 

Density (kg/dm3) @ 20 °C 3.339 3.27 

Vapour pressure (Pa) @ 20 °C NA NA 

Vapour density(air=1) NA NA 

Water solubility (g/L) 275 @ 0 °C, 909 

@ 100 °C 

133 @ 40 °C, 

497.5 @ 100 °C 

pH in solution NA NA 

Octanol / water partition coefficient (log Pow) NA NA 

Dissociation constant (pKa) NA NA 

Oxidation reduction potential NA NA 

Corrosivity to Material Non-corrosive NA 

Reactivity to container material NA NA 

Auto ignition temperature (°C) NA NA 

Explosive Properties NA NA 

Oxidizing properties NA NA 

Surface tension (dyne/cm) NA NA 

Viscosity (cP) @ 15°C NA 1.164 

Thermal stability and breakdown product Missing NA 

Other physical and Chemical property Missing NA 

Shaded areas indicate that the data are not required NA = not available or not applicable 

2 MAMMALIAN TOXICITY 

2.1 Acute mammalian toxicity

2.1.1 The data available to the Group are summarized in the table below. 

 Bromate 

Exposure Route Value Species Reference 

Oral LD50 (mg/kg) 280 Rat, Mouse, and 

Hamster 

WHO, 2005 

Dermal LD50 (mg/kg) Missing 

Inhalation LC50 (mg/l/4h) Missing 

 Sub-acute toxicity

NOAEL oral (mg/kg 

bw/day) 2 weeks 

108 (based on 

changes in enzyme 

activities) 

SPF Mouse WHO, 2005 
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2.1.2 The Group noted that the inhalation and dermal toxicity data were missing and a short 

literature search suggested that they had not been determined. 

2.1.3 It was also noted that the applicant had indicated that ëthere is no scientific evidence that 

the bromate ion and compounds are absorbed through the skiní. In addition, the applicant 

indicated that ship safety regulations ensure that the crew does not enter a ballast water tank 

unless it is dry and has been properly ventilated thus minimizing any potential risk to the crew. 

2.1.4 Notwithstanding this observation, the Group noted that the lethal doses of bromate seem 

to be very similar across rodent species, and that the toxic signs and symptoms, observed at 

autopsy, included hyperaemia of the stomach and congestion of the lungs as well as damage to 

renal tubules including necrosis in the proximal tubular epithelium. 

2.1.5 In addition, sub-acute adverse effects from bromate (potassium bromate) were reported 

in a two week oral study made with mice, as changes in enzyme activities, at doses 

of 270mg/kg bw/day and above. 

2.1.6 Based on the available information, the Group agreed to use a NOAEL for bromate 

of 108mg/kg/day (WHO, 2005). 

2.2 Corrosion/Irritation

2.2.1 A summary of the available corrosion/irritation data for bromate ions is shown in the 

table below. 

 Species Method Results 

(including scores 

where available) 

Reference/Comments/Justification 

for missing data

Skin Not specified 

Human 

 Irritant 

Irritant 

EEC Classification R36/37/38 

RTECS 

Eye Not specified 

Human 

 Irritant 

Irritant 

EEC Classification R36/37/38 

RTECS 

2.2.2 It was noted that there no inhalation irritation data had been provided. It was also noted 

that the applicant had stated ìbromate compounds are not volatile. Therefore, there is no danger 

of them being inhaledî. 

[2.2.3 Whilst the Group recognized that inhalation of bromate vapours was not possible under 

normal conditions, inhalation of mists, vapours or sprays might be of some concern.] 

2.3 Sensitization

2.3.1 The Group noted that sensitization data had not been provided for bromate ions. 

However, it was also noted that the EEC Classification for bromate ions did not include R43 

(May cause sensitization by skin contact). 

2.4 Repeated dose toxicity

2.4.1 A summary of the available repeated dose toxicity data for bromate ions is shown in the 

table below. 
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Exposure Route 

Exposure Duration 15 weeks 

Exposure dose 30mg/kg/day 

Species Rats 

Method 

Results Observed adverse effects: significant increases in blood serum 

parameters indicative of liver and kidney toxicity 

NOAEL 30mg/kg bw/day 

NOEL 

Reference/Comments/ 

Justification for missing 

data 

2.4.2 It was noted that exposure of rats to bromate for 15 weeks demonstrated a No Observed 

Adverse Effect Level (NOAEL) of 30 mg/kg/day. One thirteen week rat oral exposure study, at a 

dose of 63 mg/kg/day, showed adverse effects with significant increases in blood serum 

parameters indicative of liver and kidney toxicity (including glutamate oxaloacetate 

transaminase, lactate dehydrogenase, cholinesterase and blood urea nitrogen). 

2.5 Chronic and long-term toxicity 

2.5.1 The Group noted that the systemic toxicity of bromate (administered as potassium salt) 

had been reported from long-term studies designed to evaluate bromate carcinogenicity in rats 

and mice (WHO, 2005). The data show that the kidney is the major target organ of 

bromate-associated toxicity and that rats are more sensitive than mice to bromate treatment. 

2.5.2 Following 15 months exposure to 30mg/kg/day of bromate in drinking water, changes to 

the kidneys of the exposed rats were observed along with increased blood urea nitrogen and 

structural abnormalities of the cortical tubules. From these observations, the NOAEL could not 

be determined but a LOAEL of 30mg of bromate/kg/day had been identified as part of the study. 

2.6 Development and Reproductive Toxicity 

Exposure Route Oral 

Exposure Duration 5 and 8 generations 

Exposure dose 15mg/kg/day 

Species Rat and Mouse 

Method 

Results No development of reproductive toxicity observed 

NOAEL 

NOEL 

Reference/Comments/ 

Justification for missing 

data 
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2.6.1 The Group noted that no effects on reproductive performance had been observed in a 

study made with rats and mice fed with 15mg potassium bromate/kg over five and eight 

generations, respectively. Based on the test results, the Group concluded that bromate does not 

indicate to have developmental or reproductive toxicity. 

2.7 Carcinogenicity/Mutagenicity

2.7.1 A summary of the available carcinogenicity and mutagenicity data for bromate ions is 

shown in the table below. 

 Species Method Details Results Reference/Comments/ 

Justification for 

missing data 

Carcinogenicity Rats Possible human 

carcinogen 

LOEL=6mg/kgday

IARC (Group 2B) 

Mutagenicity Bacteria 

Hamster 

Ames test Mutagenic 

Mutagenic 

2.7.2 The Group noted that bromate ions are active oxidants in biological systems and have 

been shown to cause an increase in renal tumours, peritoneal mesotheliomas and thyroid 

follicular cell tumours in rats, and to a lesser extent in hamsters and mice. The lowest dose at 

which an increased incidence of renal tumours was observed in rats was 6mg/kg/day. 

2.7.3 A clear dose-response relationship has been observed in tumour incidence and the 

severity/progression of tumours. The weight of evidence clearly indicates that bromate has the 

potential to be human carcinogen. 

2.7.4 In particular potassium bromate, is considered mutagenic both in vitro and in vivo. In 

fact, positive results were obtained in bacteria test (Ames test), chromosome aberrations in 

cultured Chinese hamster fibroblast cells, acute cytogenetic effects on rat bone marrow cells and 

in the mouse micronucleus test. 

2.7.5 IARC classified it in Group 2B (possible human carcinogen). 

2.8 Toxicokinetics

2.8.1 The Group noted that, following oral administration, bromate is rapidly absorbed from the 

GIT. It was not detected in rat tissues following intragastric dose, but was significantly increased 

in plasma, red blood cells, pancreas, kidneys, stomach, and small intestine. 

2.8.2 It was noted that bromate can be converted into hypobromic acid by hypochloric acid in 

the stomach. liver and kidneys that may metabolise bromate to bromide by a process involving 

glutathione, although only small amounts appear to be reduced in this way. Bromate is excreted 

mainly in the urine as bromate and bromide and some may also be eliminated in the faeces. 

Bromate concentrations in urine peak at about 1h, and bromate is not detectable in plasma 

after 2 hours. 
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3 ENVIRONMENTAL EFFECTS AND FATE 

3.1 Acute aquatic toxicity 

3.1.1 The table below summarizes the evaluation of the acute aquatic toxicity of bromate ions 

in fish, crustaceans, algae and other organisms. The data on the acute toxicity of the Active 

Substance and the Relevant Chemical are shown in Table T8.1. 

Test 

Substance 

F 

C 

A 

Species Effect Value 

F Oncorhynchus keta 96-h LC50 512 mg/L 

C Crassostrea gigas 48-h EC50 30 mg/L Bromate 

ion A Missing 

 F = Fish, C = Crustacea, A = Algae 

3.1.2 Based on these data the 48-h EC50 = 30 mg/L will be used as the value to take into 

account in the further considerations on the risk assessment. 

3.1.3 No data waivers were considered necessary as all the required data had been provided. 

3.2 Chronic Aquatic toxicity 

3.2.1 The Group noted that no chronic aquatic toxicity data had been provided for bromate 

ions. 

3.3 Information on Endocrine Disruption 

3.3.1 The Group noted that there was no information related to the endocrine disruption 

potential for this chemical. 

3.4 Sediment Toxicity 

3.4.1 The Group noted that there were not data on sediment toxicity. 

3.5 Bioavailablity/Biomagnification /Bioconcentration 

Log Pow BCF Koc Calculated 

Environmental 

Distribution 

Ratio 

1⁄2 life Reference 

Assumed 

<3 

Based on 

structure 

 Assumed 

< 

Based on 

structure 

 

3.6 Food Web/Population Effects 

3.6.1 The Group noted that there were not data on food web/population effects. 
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3.7 Environmental fate 

3.7.1 It was noted that no information on the fate and behaviour of bromate ions was presented 

to the Group. However, based on the nature of these substances this was considered justified. 

3.7.2 The group concluded that bromate ions did not present a risk to the environment. 

* * * 
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Appendix 3 

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF BROMOFORM 

1 PHYSICOCHEMICAL PROPERTIES

1.1 The following table shows the physical properties of the Relevant Chemical 

(Bromoform): 

Physical property Bromoform 

CAS number 75-25-2 

Molecule weight 252.77 

Melting point (°C) 8.0-8.5 

Boiling point (°C) 149.5 °C 

Flash point NA 

Density (kg/dm3) @ 20°C NA 

Vapour pressure (Pa) @ 20°C 667 

Vapour density (air=1) 8.72 (calculated) 

Water solubility (mg/L) @ 25 °C 3100 

pH in solution NA 

Octanol / water partition coefficient (log Pow) 0.38 

Dissociation constant (pKa) 2.06 

Oxidation reduction potential NA 

Corrosivity to Material Not corrosive 

Reactivity to container material NA 

Auto ignition temperature (°C) NA 

Explosive Properties NA 

Oxidizing properties NA 

Surface tension (mN/m) @ 15°C 46.18 

Viscosity (cP) @ 10°C 2.217 

Thermal stability and breakdown product Gradually decomposes at elevation of 

temperature 

Other physical and Chemical property Clear, colourless solution 

Shaded areas indicate that the data are not required 

NA = not available or not applicable 

2 MAMMALIAN TOXICITY 

2.1 Acute mammalian toxicity

2.1.1 The data available to the Group are summarized in the table below: 

 Value Species Reference/Comments/Justification 

 for missing data 

Oral LD50 (mg/kg) 707-1550 Rat & Mouse EHC 216, 2000 

Dermal LD50

(mg/kg)

 

Inhalation LC50

(μg/L/4h) 

7000 Dog caused death after 1h 
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2.1.2 The Group noted that the applicant had neither provided dermal nor inhalation toxicity 

data for bromoform. However, it was noted that the EEC classify the product as R23 (Toxic by 

inhalation) and RAIS indicate that inhalation of >=7000μg/L caused deep anaesthesia in dogs 

after 8min and death after 1h. 

2.1.3 The Group agreed that the missing data should be provided by the applicant for Final 

Approval as these effects were considered relevant for conducting the risk assessment. 

2.2 Corrosion/Irritation

2.2.1 A summary of the available corrosion/irritation data for bromoform is shown in the table 

below: 

 Species Method Results 

(including 

scores where 

available) 

Reference/Comments/Justification 

for missing data

Skin Human Not specified Irritant MSDS 

Eye Human Not specified Irritant MSDS 

Inhalation Human 0.03-1.2 μg/L Irritant MSDS 

2.3 Sensitization

2.3.1 The Group noted that sensitization data had not been provided for bromoform. However, 

it was also noted that the EEC Classification for bromoform did not include R43 (May cause 

sensitization by skin contact). 

2.4 Repeated dose toxicity

2.4.1 A summary of the repeated toxicity data evaluated by the Group for bromoform is shown 

in the table below: 

Exposure Route Oral 

Exposure Duration 13 weeks 

Exposure dose Missing 

Species Rats and Mouse 

Method 

Results 

NOAEL 25mg/kg/day (rat), 100mg/kg/day(Mouse) 

NOEL 

Reference/Comments/ 

Justification for missing 

data 

EHC 216(2000) 

2.4.2 The Group noted a 13-week study, performed in rats, where a NOAEL of 

25mg/kg bw/day could be derived on the basis of the absence of liver lesions whereas in the 

study in mice was 100mg/kg bw/day (NTP, 1989). 
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2.5 Chronic and long-term toxicity

2.5.1 A summary of the chronic toxicity data evaluated by the Group for bromoform is shown 

in the table below: 

Exposure Route Oral 

Exposure Duration 2 years 

Exposure dose 100 and 200 mg/kg/day 

Species Rat 

Method 

Results Small increase in tumours of the large intestine 

NOAEL 

NOEL 

Reference/Comments/ 

Justification for missing 

data 

EHC 216(2000) 

2.5.2 The Group noted that no neoplastic effects were associated with the exposure of mice to 

bromoform. However, adenocarcinomas of the colon or rectum were observed in 3/50 male rats 

dosed with 200mg/kg and 1/50 female rats dosed with 100mg/kg and 8/50 female rats dosed 

with 200mg/kg (c.f. 0/48 in female control rats). 

2.6 Development and Reproductive Toxicity

2.6.1 A summary of the development and reproductive toxicity data evaluated by the Group for 

bromoform is shown in the table below: 

Exposure Route Oral Oral 

Exposure Duration At days 6-15 of gestation 105 days 

Exposure dose 50, 100 and 200 mg/kg/day 

Species Rat Rats (male and female pairs) 

Method 

Results Evidence of foetotoxic response.

No foetal malformations 

observed 

No detectable effect on fertility, 

litters/pair, live pups/litter, 

proportion of pups born alive, 

sex or body weights 

NOAEL 

NOEL 

Reference/Comments/ 

Justification for missing 

data 

EHC 216 (2000) EHC 216 (2000) 

2.6.2 It was noted that Ruddick et al. (1983) had conducted a teratological investigation in 

Sprague-Dawley rats, where bromoform was administered by gavage at dose of 50, 100 

or 200mg/kg bw/day on gestation days 6-15. Evidence of foetotoxic response was observed, but 

there were no foetal malformations. This study was used to examine effects on fertility and 

reproduction in Swiss CD-1 female rats. There were no detectable effects of bromoform on 

reproduction function. Bromoform was found to induce resorption in F344 pregnant rats, at 

higher doses (150 and 200mg/kg bw/day). 
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2.7 Carcinogenicity/Mutagenicity

2.7.1 A summary of the carcinogenicity and mutagenicity data, evaluated by the Group for 

bromoform, is shown in the table below: 

 Species Method Details Results Reference/Comments/ 

Justification for 

missing data 

Carcinogenicity Rats 5 days exposure/week 

for 2 years 

No evidence 

observed 

NTP, 1989a 

Mutagenicity Bacteria 

Not 

identified 

(Ames test) 

In vivo 

Mutagenic 

Inconclusive 

2.7.2 The Group noted that IARC had evaluated carcinogenicity of bromoform and concluded 

that there is inadequate evidence for its carcinogenicity in humans and limited evidence for its 

carcinogenicity in experimental animals. IARC classified bromoform in Group 3 (not 

classifiable as to its carcinogenicity to humans). EPA (2005) classified bromoform as possible 

human carcinogen (Group 2B). 

2.7.3 In addition, the Group noted that bromoform is largely positive in bacterial assays of 

mutagenicity and appeared to be more potent than the other brominated THMs. In vivo studies 

have given contradictory results. 

2.7.4 The Group noted that the applicant had not submitted any data related to mutagenicity. 

However, it was agreed that, with the development, reprotoxicity and carcinogenicity data, this 

additional information was not essential. 

2.8 Toxicokinetics

2.8.1 The Group noted that the applicant had indicated that the limited data available indicates 

that bromoform is rapidly and efficiently taken up from the Gastro Intestinal Tract (GIT). 

However, there were no data available for uptake through inhalation or dermal absorption. 

2.8.2 It was also noted that, although bromoform has greater propensity for metabolism, it 

appears to be less potent toxicant and carcinogen than other brominated THM based on the NTP 

(1985, 1987) bioassays and numerous in vivo toxicity studies. A possible explanation is the less 

bioavailability resulting from the greater lipophilicity of this compound (logPow~240) that 

associated to greater reactivity of bromoform metabolites, may prevent it from reaching critical 

target sites. 

2.8.3 Available toxicity data indicate that target tissues are similar in humans, rats and mice. 

Limited data suggest that effect levels are generally similar across species (US Department of 

Health and Human Services, 2005). 
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3 ENVIRONMENTAL EFFECTS AND FATE

3.1 Acute aquatic toxicity

3.1.1 The table below summarizes the evaluation of the acute aquatic toxicity of bromoform, 

made by the Group. 

 Species Effect Value 

Fish Cyprinodon variegates 96-h LC50 7.1 mg/L 

Crustacea Americamysis bahia 96-h LC50 24.4 mg/L 

Algae Skeletonema costatum 168-h IC50 32 mg/L 

3.2 Chronic aquatic toxicity

3.2.1 The table below summarizes the evaluation of the chronic toxicity of bromoform, made 

by the Group. 

 Species Effect Value 

Fish Cyprinodon variegates 28-d NOEC 4.8 mg/L 

Crustacea 

Algae 

3.2.2 The Group agreed that the only value available for deriving a chronic PNEC for 

bromoform was therefore 28d NOEC = 4.8 mg/L for the species Cyprinodon variegates. This 

value was used in the further considerations on the risk assessment. 

3.3 Information on Endocrine Disruption 

3.4 Sediment Toxicity 

3.5 Bioavailablity/Biomagnification /Bioconcentration 

3.6 Food Web/Population Effects 

3.7 Environmental Fate 

3.7.1 In the following table an overview is given of the environmental fate and behaviour data 

of bromoform. 
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Property Bromoform 

Hydrolysis 686 y 

pH5 (seawater) 

pH7 (seawater) 

pH9 (seawater) 

Photolysis NA 

Degradation in seawater NA 

Ready biodegradation NA 

Biodegradation Water: 38 d 

Soil: 75 d 

Sediment: 340 d 

Air: 380 d 

Sorption (Koc) (dm3/kg) 114.8 (62 ñ 126) 

Bioconcentration 14 

Anaerobic degradation 21 ñ 42 d 

 NA = not available or not applicable 

3.7.2 The fate data on bromoform indicate that it is not clear on beforehand that there is no risk 

to the environment because of low exposures. Due to the half lives of around 50 d substantial 

levels of bromoform may still occur after discharge of the ballast water into the receiving 

environment. 

3.7.3 Therefore the Predicted Environmental Concentration (PEC) was calculated at the 

moment of discharge and after 28 days, being the duration of the chronic toxicity study with 

Cyprinidon variegates. 

3.7.4 The Group agreed that as a result, the PEC/PNEC ratio was assumed to be <<1 and as it 

was not defined as a PBT, the ozone itself would not present an environmental risk. 

* * * 
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Appendix 4 

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF 

TOTAL RESIDUAL OXIDANTS (TRO) 

1 PHYSICOCHEMICAL PROPERTIES

1.1 It was recognized that it was not possible to measure the physical properties of the 

Relevant Chemical (TOR) due to it being a mixture of transient nature. 

2 MAMMALIAN TOXICITY 

2.1 Due to its very short life nature, the Group agreed that it is plausible that no data related 

to TRO would be available for toxicological effects assessment. 

3 ENVIRONMENTAL EFFECTS

3.1 Acute aquatic toxicity

3.1.1 The table below summarizes the evaluation of the acute aquatic toxicity of TOR, made by 

the Group. 

 Species Effect Value 

Fish Morone saxatilis 96-h LC50 0.08 mg/L as TRO 

Crustacea Crab 48-h LC50 0.08 mg/L as TRO 

Algae Skeletonema costatum 24-h EbgCx <0.1 mg/L as TRO 

3.2 Chronic aquatic toxicity

3.2.1 The table below summarizes the evaluation of the chronic toxicity of TOR, made by the 

Group. 

 Species Effect Value 

Fish 

Crustacea 

Algae 

*** 

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I:\MEPC\56\2-2.doc 

ANNEX 7 

REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES 

Hybrid Ballast Water Treatment System using Seawater Electrolytic Process 

Submitted by Japan as MEPC 56/2 

0 SUMMARY 

0.1 The BWM system envisages that a sidestream of the ballast intake is passed through a 

high output electrolytic cell and then injected back into the ballast water line to create a Free 

Active Chlorine (FAC) concentration of 5 mg/L. This is considered by the applicant to be 

sufficient for sterilization. Control and measurement devices are still under development. 

0.2 Sterilization of the sea water during the laboratory testing seems to have been carried out 

with effluent produced by using ìa small device fitted with the same types of electrodes used for 

the actual seawater electrolytic processî. The system was run so as to generate an FAC 

concentration of 50(+3)mg/L and then apparently diluted down to 5 mg/L. The Group 

recognized that the applicant had used the term ëFACí, for the initial dose, as theoretical rate and 

the term ëTRCí as for the real concentration after some degradation. The Group understood, 

from the submitted data, that the test water was sterilized and then allowed to remain in the tank 

for 2 days before sampling for ecotoxicity testing and analytical chemistry. Ecotoxicity testing 

indicates that the treated test water was toxic to aquatic organisms. 

0.3 The application intends to use a FAC value of 5 mg/L, i.e. a value apparently 

consistent with WHO recommendations for disinfection of drinking water. It describes the 

treatment of ballast water on uptake, with possibilities for recirculation to maintain a TRC level 

of 0.1 to 3 mg/L during a voyage and/or on discharge. However, the risk assessment appears to 

have been carried out on the basis of treatment at simulated uptake only. Further treatment during 

a voyage and/or on discharge would lead to higher PEC values. Given the uncertainties in the 

description of the system, the reliability of the PEC values presented in the application is open to 

question. Furthermore, the levels of by-products such as tribromomethane are likely to increase if 

treatment during a voyage is carried out. A proper risk assessment cannot therefore be carried out 

until a clear description of the operation is provided. 

0.4 Relevant substances/byproducts were measured at detection limits of 1 (trihalomethanes) 

to 10 μg/L (haloacetic acids). The majority of compounds were found to be below these detection 

limits. However, it was evident from a footnote on the analytical certificates that six days had 

elapsed between sampling and analysis. For final approval, the group would like to evaluate the 

range of potential by-products at lower detection limits, e.g. similar to those used in routine 

surface water monitoring of 0.01-0.05 μg/L, with supporting evidence of same day analysis and 

clear evidence of how sample handling, storage and analysis were achieved. The analytical 

measurements carried out during testing for basic approval are summarized in the application, 

e.g. the maximum concentration of tribromomethane is reported as 160 μg/L but this was 

considered by the group to be an underestimate. 

0.5 The system can only work properly when salinity (chlorine ion concentration) is above 

certain levels. This level is not specified in the dossier, nor is it stated how the power supply to 

the electrolytic cell is to be adjusted in such cases of differing salinities. Further, this will cause 

limitations to the effective use of the system onboard ships. 
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0.6 The Group identified various risks relative to ship and crew safety that are in need to be 

addressed. 

0.7 Due to the lack of required data, the Group were unable to carry out any meaningful Risk 

Assessment and so do not recommend that this system be given Basic Approval. 

1 INTRODUCTION 

1.1 The data used to evaluate this system were extracted from that supplied by Japan in 

submission MEPC 56/2 that was supported by additional confidential information provided to the 

GESAMP-BWWG Secretariat.

2 COMPLETENESS OF THE DOSSIER 

2.1 The application dossier was not considered to be complete for the following reasons: 

 .1 the dossier is considered to describe a conceptual treatment of ballast water with 

electrolysis of seawater. It describes three means of treatments; at uptake, during 

voyage and at discharge. The dossier gives only information about environmental 

and safety aspects based on a simulation of the treatment on uptake; 

 .2 experimental results presented in the dossier are only based on small-scale 

laboratory experiments (capacity of the electrolytic cell=500 ml) and did not use 

flow through electrolytic cells such as would be installed on ships; 

 .3 the dossier gives no information on the intended control scheme. An automatic 

monitoring sensor for residual chlorine is said to be under development; 

 .4 calculation of the predicted environmental concentration (PEC) in the dossier is 

based on the CHEMMAP model using a concentration of active substance found 

in treated water two days after treatment. This scenario assumes that all 

discharged ballast water is kept at least two days in ballast tanks before discharge. 

This is in conflict with the three alternatives for treatment. PEC values from the 

modelling are not therefore considered reliable enough to carry out the risk 

assessment. 

3 DESCRIPTION OF THE BWMS

3.1 Overview of the system 

3.1.1 The submission indicates that the system proposed utilises a mechanical filtration system 

to remove or deactivate large organisms of >50μm followed by a seawater electrolytic process 

producing active chlorine to treat the ballast water. The chlorine is produced by the seawater 

electrolytic process at a comparatively high concentration in a side-stream from the shipsí ballast 

system that is then injected back into the ballast main where the concentration of chlorine is then 

diluted to the intended dose level. The submission indicates that the intended application would 

normally be during ballast water uptake, but also that the system can be applied during 

navigation or ballast water discharge should this be required to maintain the treated water 

minimum TRC disinfection levels recommended by the manufacturer. 
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3.1.2 It was noted that the submission indicates the electrolytic process proposed is a further 

application development of the marine-Growth-Prevention System (MGPSÆ) developed by 

Mitsubishi Heavy Industries Ltd. The MGPS system has used chlorine generated from seawater 

by electrolysis to control the problems associated with the establishment and growth of marine 

species in ships seawater cooling systems for many years. 

3.2 Active Substances, Relevant Chemicals and Other Chemicals 

3.2.1 The Group noted that the applicant had identified chlorine gas as the primary Active 

Substance that is generated by the electrolysis of seawater onboard. However, it was also noted 

that the chlorine gas rapidly dissolves in seawater to form free active chlorine as a mixture of 

hypochlorous acid (HClO) and hypochlorite ion (ClO-

) that should be regarded as Active 

Substances also. 

3.2.2 The Group agreed that the use of information on sodium hypochlorite (NaClO) as 

surrogate data for hypochlorite ion was acceptable for the evaluation. 

3.2.3 The Group also noted that, whilst it is this free active chlorine that has the disinfectant 

properties, it also reacts with naturally occurring nitrogen compounds and organic compounds to 

form chloramines. The applicant had indicated that the resultant mixture of free active chlorine 

and chloramines were referred to as Total Residual Chlorine (TRC) or Total Residual Oxidant 

(TRO). 

3.2.4 The Group noted that, due to the naturally occurring presence of bromine in seawater 

(~65mg/L), an equilibrium exists between chlorine and bromine containing compounds. As a 

result, when chlorine reacts with seawater to form hypochlorous acid and chlorite ions, 

hypobromous acid and bromite ions are also formed. These react with naturally occurring 

organic compounds, inorganic nitrogen compounds and carboxylic acids, examples of which are 

shown below as being relevant to this application: 

 .1 Chlorine gas reacts with water to form the Active Substances (TRO) 

 Cl2 + water → HClO + ClO-

 (TRO) (Equation not balanced) 

 .2 Hypochlorous acid can then react with nitrogen compounds such as ammonia, as 

shown below: 

 NH3 + HClO → NH2Cl + H2O 

 NH2Cl + HXO → NHCl2 + H2O 

 NHX2 + HClO → NX3 + H2O 

 However, at the pH of seawater (pH8 ), monohaloamines are produced which, for 

practical reasons are deemed to be included in the definition of TRO 

 .3 Hypochlorous acid can also react with naturally occurring organic compounds to 

form trihalomethanes, such as: 

 RCOCH3 + 3HOCl → CHCl3 + RCOOH + 2H2O 
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 .4 In addition, hypochlorous acid can also react with naturally occurring carboxylic 

acids to generate halogenated acetic acids as shown below: 

 RCHO + HOX → RCOOH + H+

 + X-

 RCOOH + HOX → RXCOOH + H2O 

 RXCOOH + HOX → RX2COOH + H2O 

 RX2COOH + HOX → RX3COOH + H2O 

 Where X = Cl or Br 

3.2.5 The Group noted that, having identified these reactions, the applicant had analysed 

chlorine treated seawater with the results shown below: 

Item Analysis value 

(mg/l) 

Detection 

limit 

(mg/l) 

Sample Condition

 Sampling Point 

Sampling Date 

Initial chlorine concentration (FAC) 

POC 

 DOC 

 TOC (=DOC+POC) 

 pH 

Tokyo 

Bay 

2006.7 

(5.0)a,b

2.49 b

0.82 b

3.31 b

8.3 (21°C)

Oigawa Port 

2006.9 

(5.0) a,c

0.1c

1.0c

1.1c

8.1 (19°C) 

0.05 

2(μg) 

0.05 

- 

- 

Trihalomethanes 

trichloromethane (CHCl3) 

bromodichloromethane (CHBrCl2) 

dibromochloromethane (CHBr2Cl) 

tribromomethane(CHBr3) (bromoform) 

N.D. 

N.D. 

0.006 

0.16 

N.D. c

N.D. c

0.003 c

0.15 c

0.001 

0.001 

0.001 

0.001 

Haloacetic acids

2-monochloroacetic acid (CH2ClCOOH) 

2,2-dichloroacetic acid (CHCl2COOH) 

2,2,2-trichloroacetic acid (CCl3COOH) 

2-monobromoacetic acid (CH2BrCOOH) 

2,2-dibromoacetic acid (CHBr2COOH) 

2,2,2-tribromoacetic acid (CBr3COOH) 

2,2-bromochloroacetic acid (CHBrClCOOH) 

2,2,2-bromodichloroacetic acid (CBrCl2COOH) 

2,2,2-dibromochloroacetic acid (CBr2ClCOOH) 

N.D. 

N.D. 

N.D. 

N.D. 

0.02 

0.03 

N.D. 

N.D. 

N.D. 

N.D. c

N.D. c

N.D. c

N.D. c

N.D. c

0.01 c

N.D. c

N.D. c

N.D. c

0.01 

0.004 

0.02 

0.01 

0.01 

0.01 

0.01 

0.01 

0.01 

 Where: 

 a: Test seawater was electrolyzed to prepare an electrolytic solution containing about 

50 mg of TRC/l. TRC was quantitatively determined by iodometry followed by 

mixing of the electrolytic solution with test seawater. 

 b: Results of analysis carried out by the applicant 
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 c: Results of analysis carried out by the applicantís laboratory in chemical tests on 

treated seawater (see paragraph 5.2), with six day old samples 

 N.D.: Not Detectable. 

3.2.6 The Group noted that, based on this analysis and, in addition to the Active Substances 

(Chlorine and TRO), the applicant identified the following by-products as Relevant chemicals, 

some of which are produced by the interaction with naturally occurring bromide ions: 

 Maximum concentration identified 

(mg/L) 

tribromomethane 0.16 

dibromochloromethane 0.006 

2,2-dibromoacetic acid 0.02 

2,2,2-tribromoacetic acid 0.03 

3.2.7 The Group noted that analyses had only been carried out using samples from laboratory 

scale experiments where still water had been electrolysed in a 500 ml cell and diluted manually 

with untreated water. The Group considered that results from such small scale experiments were 

of limited value for evaluation of full scale systems. 

3.2.8 It was also noted that the dossier did not include information about other relevant 

halogenated chemicals that may be produced because they were not detected in the chemical 

analysis. As a result, the Group recommended that additional analysis be included in the further 

testing both onboard ships and in land-based tests and that these data are submitted in the 

application for final approval. 

3.2.9 In addition, the Group agreed that the Level of Quantification (LOQ) of the analytical 

methods used for the potential by-products measured should be at a level that will confirm that 

the potential amount of by-products produced by the system is sufficiently low and meets 

the international standards on these substances. The Group considered that the LOQs generally 

used to be too high. It is common to determine these contaminants in surface waters at levels 

of 0.01 ñ 0.05 μg/L. 

3.2.10 The Group noted that the applicant had also indicated that hydrogen gas is also 

generated by the system but, as there were no reported (eco-)toxicity data for this chemical, only 

its safety hazards were considered and the product was not regarded as a Relevant Chemical. 

3.2.11 The evaluation of the Active Substances and Relevant Chemicals are shown in the 

appendices as indicated below: 

 .1 free active chlorine (TRO) Appendix 1; 

 .2 monochloramine Appendix 2; 

 .3 tribromomethane Appendix 3; 

 .4 dibromochloromethane Appendix 4; 

 
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 .5 2,2-dibromoacetic acid Appendix 5; 

 .6 2,2,2-tribromoacetic acid Appendix 6. 

4 HUMAN HEALTH ASSESSMENT 

4.1 The seawater electrolysis generates in situ chlorine gas (Cl2) that rapidly dissolves to 

form free active chlorine (FAC), a mixture of hypochlorous acid (HOCl) and hypochlorite ion 

(OCl-

) that is expected to have a very short-life. Subsequently, free chlorine reacts with nitrogen 

compounds existing in the biological materials forming chloramines that act as secondary 

disinfectants. This constitutes total residual chlorine (TOC) or total residual oxidant (TRO) used 

to assess FAC, considered to be the Active Substance. 

4.2 It was acknowledged that chlorine in the form of hypochlorous acid/hypochlorite ion 

(HOCl/ClO-) is able to react with bromide ion, oxidizing it to hypobromous acid/hypobromite ion 

(HOBr/OBr-). Hypochlorous acid and hypobromous acid react collectively with natural organic 

matter (NOM) to form chlorine DBPs, including THM, haloacetic acids (HAAs), 

haloacetonitriles (HANs). The relative amounts of TOC, bromide and chlorine will affect the 

species distribution of THMs (four species: chloroform, bromoform, bromodichloromethane 

(BDCM) and dibromochloromethane (DBCM)), HAAs and HANs. 

4.3 The Group considered the disinfection by-products (DBP) to be relevant chemicals, not 

only the compounds referred in the application but others, as above mentioned, expected to be 

produced in such an electrolytic system. The existing weight of evidence associated with the 

potential for human toxicity of these compounds makes this a major concern and requires strict 

mitigation measures namely for occupational exposure. 

4.4 The presence of bromine in the seawater enhances lipid solubility of the halomethanes 

and consequently, uptake into the tissues, increasing the capacity of their chemical reactivity and 

the likelihood of biotransformation to more toxic metabolites. According to existing information 

(EPA 216, 2000), cancer following chronic exposure is the primary hazard of concern for 

brominated THMs. 

4.5 Most of the experimental toxicity data on chlorine are found under the WHO drinkingwater disinfectants and disinfectant by-products research program where evidence is normally 

associated to chlorine administered via drinking-water. Although being aware that such exposure 

is not particularly relevant to exposures in the Ballast Water Treatment Systems, the Group 

consider these data to substantiate the qualitative assessment. 

4.6 From the information presented it is concluded that the critical health effects resulting 

from human exposure to the active substances and relevant chemicals generated by the system 

are mostly acute in nature (corrosiveness, irritancy to skin and eyes, and respiratory tract); 

however, and this mostly applies do DBPs, concerns are also addressed in literature related to 

genotoxicity and carcinogenicity to humans, depending on the severity of exposure and under 

long term exposures (e.g. occupational scenarios). 

4.7 Other relevant factors have also to be taken into account when assessing human exposure 

towards chemicals include, inter alia: 

 
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 .1 the variability in human individual sensitivity (e.g. genetic polymorphism); 

 .2 the fact that most of these compounds are volatile liquids at room temperature, 

therefore inhalation becomes an important exposure route in addition to dermal; 

 

 .3 the fact that complex mixtures of disinfectants and DBPs, according to the actual 

knowledge, interact in an additive way, leading to cumulative effects at low 

concentration (EHC 216, 2000). 

5 RISKS TO THE SAFETY OF THE SHIP, ITS CREW AND THE GENERAL 

PUBLIC 

5.1 The Group noted that the applicant had indicated that there are risks associated with the 

excessive production of the Active Substance that might leak from the equipment. However, the 

electrolytic cell is turned off automatically if there is leakage or if the seawater flow rate to the 

electrolytic cell falls below a preset level. It is recommended that confirmation is obtained that 

the shut down parameters include chlorine gas detection in the vicinity of the chlorine generator 

and chlorine injection piping to the ballast system to minimise the possibility of unacceptable 

personnel exposure. The Group considered that this was particularly relevant as the electrolytic 

cell produces relatively high chlorine concentrations. 

5.2 It was noted that the system is a development of an existing application in which the 

initial dosing rate may not be of particular concern due to the normal operating procedures for 

that particular system. Whilst recognizing that the TRC discharge level would be monitored to 

keep it within acceptable limits, the Group was concerned that the submission did not clearly 

indicate that the TRC or other relevant parameters in the treated water would be adequately 

monitored. In addition, the Group noted that the sensor for such monitoring is still under 

development and that the chlorine levels reported were derived from theoretical calculations 

based on the electric current to be applied to the electrolytic cell. It is recommended for the 

purpose of further approval that the TRC concentration following injection in the ballast line is 

also appropriately monitored to ensure the levels of TRC in the treated ballast tanks do not 

exceed the anticipated levels. 

5.3 The Group noted that the applicant had indicated that the free active chlorine, generated 

by the system reacts with organic matter to form DBPs such as trihalomethane and halogenated 

acetic acids. However, the analysis of some of these products was not always sensitive enough to 

show whether they had been produced or not. Other studies have suggested that THM generation 

increases with pH, time, temperature and the amount of organic matter present. It has been 

suggested that TRC levels above 1 mg/L can produce unacceptable THM levels. As with other 

systems, unless it can be demonstrated that the levels of these compounds produced do not 

present an unacceptable human health risk, appropriate mitigation measure must be used to 

prevent human contact with the treated ballast water. Such measure might include the use of 

Personal Protective Equipment (PPE) when entering ballast water tanks. The Group agreed that 

this view emphasized the need for a quantitative human exposure risk assessment system if 

meaningful recommendations are to be made to MEPC. The formation of DBPs in the ballast 

tanks may be greatly increased if the on passage re-chlorination option described is followed, due 

to the fresh influx of available TRC. 
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5.4 The Group noted that the submission had identified an increased risk of corrosion to 

piping and the ballast tank structure that may be anticipated with the use of chlorine. However, it 

was stated that there is only a low risk of corrosion due to the “low” concentration of 5 mg FAC/l 

measured during treatment and the use of lined piping. The Group noted that other studies of the 

corrosive effect experienced with the use of chlorine had indicated a 100% corrosion effect 

increase with the use of a 5 mg/L chlorine solution and that the effectiveness of any typical 

onboard seawater piping or ballast tank protective coating system could not be guaranteed in all 

cases. The Group, therefore, recommended that the corrosive effect caused by use of the 

proposed system is verified during further testing, and that when initial trials take place onboard 

a ship, the suitability of the ships corrosion protection coatings is verified and that conditions are 

checked regularly to avoid the possibility of piping and/or structural failure. The degradation 

effect that the treatment may have on the tank coatings should also to be assessed.

5.5 The Group noted that the submission had indicated that there is an increased risk of 

explosion following the potential accumulation of hydrogen gas generated by the system. 

However, the applicant suggested that, due to its high water solubility, most of the generated 

hydrogen gas would be dissolved. Furthermore, it was indicated that the hydrogen gas would be 

discharged from the ventilation hole of the ballast tank. However, the Group agreed that there 

might be serious safety concerns with this system and so recommended that this risk be further 

evaluated before accepting that no additional precautionary measures are necessary. This will be 

especially relevant when opening ballast tanks and monitoring of the condition of the air exiting 

the tank vent system during treated water uptake or recirculation for re-chlorination. The hazards 

associated with the potential for generation of chlorine gas during the process is also in need of a 

further equivalent evaluation. Monitoring of levels of these substances and additional

appropriate safety procedures should be required as a minimum for the opening of treated ballast 

tanks and personnel tank entry until it has been verified that such precautions are unnecessary.

5.6 The Group noted that the submission indicated that the ballast water treatment system 

proposed was in an early stage of development, and that operation of the system would appear to 

be very labour intensive and time consuming until appropriate automation and controls were 

developed and incorporated. 

6 ASSESSMENT OF PERSISTENCE (P), BIOACCUMULATION (B) AND

TOXICITY (T)

6.1 The Group noted that the following classifications could be made on the PBT-criteria as 

presented in the table.

Substance Persistence Bioaccumulation Toxicity

FAC No No No

monochloramine No No No

tribromomethane Yes (half-life 340d 

in sediment)

No No

dibromochloromethane No No No

2,2-dibromoacetic acid No No ND

2,2,2-tribromoacetic acid No No ND
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6.2 Based on these results, none of the substances should be classified as a PBT-substance. 

7 ENVIRONMENTAL RISK ASSESSMENT 

7.1 Based on the available ecotoxicity data the Group derived a predicted no-effect 

concentration (PNEC) for the substances as indicated in the table. 

Substance Lowest 

L(E)C50

(mg/L) 

Lowest 

NOEC 

(mg/L) 

AF PNEC 

(μg/L) 

TRO 0.005 0.007 100 0.07 

monochloramine 0.079 NA 1000 0.079 

tribromomethane 7.1 4.8 1000 7.1 

dibromochloromethane 27 2.9 1000 27 

2,2-dibromoacetic acid 6.9 NA 1000 6.9 

2,2,2-tribromoacetic acid NA NA - NA 

7.2 Given the uncertainties in the establishment (estimation) of the PEC, as the description of 

the BWMS is considered not sufficient by the Group, it was noted that carrying out of a real risk 

assessment based on these data is not possible. First a clear indication of the possible PEC is 

required. 

7.3 It was recognized that, due to the inadequate description of this system, it was not 

possible to measure a Predicted Environmental Concentration (PEC) of possible chemicals 

released into the sea. 

8 CONCLUSIONS AND RECOMMENDATIONS 

8.1 Risks to safety of the ship

8.1.1 It was agreed that there is a potential risk of explosion due to the possible excess 

hydrogen being produced. There is also a potential risk of corrosion to parts of the ship caused 

by the possible high levels of chlorine generated by the system. 

8.2 Risks to the crew and the public

8.2.1 In addition to those points identified in paragraph 8.1.1, which pose a potential risk to the 

crew as well, the Group were concerned that the types and levels of by-products generated by the 

system might also present an unacceptable human health risk if the crew or the public are 

exposed to treated ballast water. As a result, the Group recommended that, until it can be 

demonstrated that these concerns are unfounded, appropriate mitigation measures must be used 

to prevent human contact with treated ballast water. 

8.3 Risks to the environment

8.3.1 As it was not possible to generate a value for the Predicted Environmental Concentration 

of products released into the sea, the Group could not evaluate the potential risks to the 

environment. 

* * * 
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Appendix 1 

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF FREE ACTIVE 

CHLORINE (FAC) DESCRIBED AS TOTAL RESIDUAL OXIDANT (TRO) 

1 PHYSICOCHEMICAL PROPERTIES

1.1 The Group recognized that as TRO was a mixture of chemicals (deemed to be chlorine, 

hypochlorous acid and chlorite ion, it was not possible to identify all of the physical properties 

accurately. However, the Group noted the following physical properties associated with some of 

the TRO components. 

Physical property Chlorine Hypochlorous 

acid 

Sodium 

hypochlorite 

CAS number 7782-50-5 7790-92-3 7681-52-0 

Molecule weight 70.906 52.46 74.44 

Melting point (°C) -101 - 25 

Boiling point (°C) -34.6 107 

Flash point (°C) Nonflammable 

Density (kg/dm3) @ 20 °C 3.214 at 

0°C/101.3kPa 1.21*103

Vapour pressure @ 20°C (Pa) 7.77*105 1740-2000 

Vapour density (air=1) 2.5 @ -34.6°C 

Water solubility (g/L) 14.6 @ 0°C 

5.7 @ 30°C 293 

pH in solution 

Octanol / water partition coefficient (log Pow) 

Dissociation constant (pKa) 3.4 7.5 

Oxidation reduction potential 

Corrosivity to Material 

Reactivity to container material 

Auto-ignition temperature (°C) NA 

Explosive Properties 

Oxidizing properties 

Surface tension NA 

Viscosity (mPa.s) NA 2.6 

Thermal stability and breakdown product 

Other physical and Chemical property 

2 MAMMALIAN TOXICITY (based on calcium and sodium hypochlorite data)

2.1 Acute mammalian toxicity

2.1.1 The data available to the Group are summarized in the table below. 
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Exposure Route Value Species Reference 

Oral LD50 (mg/kg) 850 WHO 2003 (Calcium 

hypochlorite 

Dermal LD50 (mg/kg) 

Inhalation LC50 (mg/l/4h) 

2.2 Corrosion/Irritation

2.2.1 A summary of the available corrosion/irritation data for TRO is shown in the table below. 

 Species Method Results 

(including scores 

where available) 

Reference/Comments/Justification 

for missing data

Skin Rabbit OECD 404 2% slight (1.2) 

20% severe (5.2) 

IUCLID 2000 sodium hypochlorite 

Eye Rabbit 5.25% irritant 

0.5% slight irritant

0.05% NOEC 

IUCLID 2000 sodium hypochlorite 

2.3 Sensitization

2.3.1 The Group noted that a 2.8% solution of sodium hypochlorite solution was not found to 

be a skin sensitizer in Guinea pigs (IUCLID 2000). 

2.4 Repeated dose toxicity

2.4.1 A summary of the available repeated dose toxicity data for TRO is shown in the table 

below. 

Exposure Route Oral 

Exposure Duration 90 days 

Exposure dose 200mg/l TRO in drinking water 

Species Mouse 

Method 

Results 

NOAEL 50 mg/l (10-12 mg/kg/day) 

NOEL 

Reference/Comments/ 

Justification for missing 

data 

MEPC 56/2 para. 2.3.3.1 (Daniel et al 1991) 

2.5 Chronic and long-term toxicity 

2.5.1 A summary of the available chronic and long-term data for TRO is shown in the table 

below. 
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Exposure Route Oral 

Exposure Duration 2 years 

Exposure dose Up to 24.2 mg/kg/day (14.4 in rats, 24.2 in Mouse) 

Species Rat and Mouse 

Method 

Results 

NOAEL 14.4 mg/kg/day 

NOEL 

Reference/Comments/ 

Justification for missing 

data 

MEPC 56/2, paragraph 2.3.4.1 (NTP 1992) 

2.6 Development and Reproductive Toxicity 

2.6.1 The Group noted that the applicant had reported that no information was available for 

tests carried out in accordance with OECD Guidelines 414 or 416. A summary of the available 

development and reproductive toxicity data for TRO is shown in the table below. 

Exposure Route Oral 

Exposure Duration 7 generations 

Exposure dose 100mg TRO/l (drinking water treated with sodium hypochlorite) 

Species Rat 

Method 

Results 

NOAEL 

NOEL 

Reference/Comments/ 

Justification for missing 

data 

MEPC 56/2, paragraph 2.3.5.1 

2.7 Carcinogenicity/Mutagenicity 

2.7.1 The Group noted that the applicant had reported that rats exposed to drinking water 

treated with up to 14.4 mg/kg/day sodium hypochlorite for 104 weeks showed no effects that 

were deemed to be carcinogenic. Similar results were shown in mice exposed to 24.2 mg/kg/d 

for 104 weeks. 

2.7.2 The Group noted that sodium hypochlorite produced mutations in an Ames test and in 

human embryo stem cells in vitro. However, no mutagenicity was observed in either a mouse 

micronucleus assay or a mouse chromosomal aberration test. 

2.7.3 A summary of the available carcinogenicity/mutagenicity data for TRO is shown in the 

table below. 
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 Species Method 

Details 

Results Reference/Comments/ 

Justification for missing data 

Carcinogenicity Not carcinogenic IARC Group D (not classifiable 

as human carcinogen). 

MEPC 56/2, paragraph 2.3.6.1 

Mutagenicity (Not) mutagenic MEPC 56/2, paragraph 2.3.7.1 

2.8 Toxicokinetics

3 ENVIRONMENTAL EFFECTS AND FATE 

3.1 Acute aquatic toxicity 

3.1.1 The table below summarizes the evaluation of the acute aquatic toxicity of TRO based on 

data provided by the applicant. 

F 

C 

A 

Species Effect Value 

(mg/L) 

Reference/Comments 

F Oncorhynchus kisutch 96h LC50 0.032 

C Ceriodaphnia dubia 24h LC50 0.005 

A Thalassiosira pseudonana 24h IC50 0.075 

M Crassostrea virginica 96h EC50 0.023 

MEPC 56/2 

para.2.2.1.1 

 F = Fish, C = Crustacea, A = Algae, Mollusc 

3.2 Chronic Aquatic toxicity 

3.2.1 The table below summarizes the evaluation of the chronic aquatic toxicity of TRO based 

on data provided by the applicant. 

F 

C 

A 

Species Effect Value 

(mg/L) 

Reference/Comments 

F 

Menidia peninsulae 28d NOEC 

0.04 

Chlorine-produced 

oxidant 

C Pandalus danae 28d NOEC 0.05mg/l Free 

Active Chlorine 

A Unknown species 7d NOEC 0.0027 mg/l 

TRO 

M Crassostrea virginica 15d NOEC 0.007mg/l 

TRO 

MEPC 56/2 

para.2.2.2.1 

F = Fish, C = Crustacea, A = Algae, Mollusc 

3.3 Information on Endocrine Disruption 

3.3.1 The Group noted that the applicant had indicated that there were no reports indicating that 

TRO might have any endocrine effects on aquatic organisms. 
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[3.3.2 However, the Group considered data on endocrine disruption for this substance not 

relevant because of the nature of the substance.] 

3.4 Sediment Toxicity 

3.4.1 The Group [agreed] with the applicantís view that, due to the estimated low Koc of TRO 

(see 3.7) it is unlikely that these will partition into sediment and cause further adverse effects to 

organisms in this area. 

3.5 Bioavailability/Biomagnification/Bioconcentration 

3.5.1 A summary of the pertinent data related to bioavailability, biomagnification and 

bioconcentration for TRO is shown in the table below. 

 Log Pow 

Hypochlorous acid -0. 87 

Sodium hypochlorite -3.42 

Based on these values the Group did not consider the substances bioaccumulative. 

3.6 Food Web/Population Effects 

3.6.1 The Group [agreed] with the applicantís view that, due to the estimated low Log Pow of 

TRO, it is unlikely that these will be accumulated through the food chain. 

3.7 Environmental Fate 

3.7.1 The Group noted that only few environmental fate data were available in the notifying 

dossier. The table gives the data available. 

 Koc (l/kg) half life (h) 

Hypochlorous acid 14.3 0.8 

Sodium hypochlorite 14.3 1.4 

3.7.2 As these chemicals have oxidizing properties in the BWMS under consideration the 

Group does expect that the amount available of these chemicals will disappear rapidly during the 

oxidizing activity. Therefore the resulting TRO in the receiving water will be very low. 

* * * 
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Appendix 2 

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF MONOCHLORAMINE 

1 PHYSICOCHEMICAL PROPERTIES

1.1 The Group noted that there were not any physical properties provided for 

monochloramine. The following data may be found in the open literature: 

Molecular formula NH2Cl 

Molecular weight 51.48 

CAS-number 10599-90-3 

Appearance Colourless 

Density NA 

Water Solubility (mg/L) Soluble 

Melting Point (°C) - 66 

Boiling Point (°C) NA 

2 MAMMALIAN TOXICITY 

2.1 Acute mammalian toxicity

2.1.1 The data available to the Group for monochloramine are summarized in the table below. 

 

Exposure Route Value Species Reference 

Oral LD50 (mg/kg) >0.8 Rat MEPC 56/2, paragraph 2.3.1.2 (not 

really an AT test) 

Dermal LD50 (mg/kg) Missing 

Inhalation LC50 (mg/l/4h) Missing 

 Sub-acute toxicity

NOAEL oral (mg/kg 

bw/day) 2 weeks 

 Missing 

2.2 Corrosion/Irritation

2.2.1 A summary of the available corrosion/irritation data for monochloramine is shown in the 

table below. 

 Species Method Results 

(including scores 

where available) 

Reference/Comments/Justification 

for missing data

Skin Missing 

Eye Missing 

Lung Irritant MEPC 56/2, paragraph 2.3.2.2 
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2.3 Sensitization

2.3.1 The Group noted that there was no indication of sensitization potential of 

monochloramine provided. 

2.4 Repeated dose toxicity

2.4.1 The Group noted that data had been provided for repeated dose toxicity studies using both 

rats and mice. As the rat data indicated a lower NOAEL, these were selected as the most 

appropriate data for use and are summarized in the table below. 

Exposure Route Oral 

Exposure Duration 90 days 

Exposure dose 0-200mg/l in drinking water = 11.6 mg/kg/day 

Species 

Method 

Results 

NOAEL 5.8 mg/kg/day 

NOEL 

Reference/Comments/ 

Justification for missing 

data 

MEPC 56/2, paragraph 2.3.3.1 

2.5 Chronic and long-term toxicity 

2.5.1 A summary of the chronic and long-term toxicity data evaluated by the Group is shown in 

the table below: 

Exposure Route Oral 

Exposure Duration 2 years 

Exposure dose 0 - 9.5 mg/kg/day (Rat) 

0 - 17.2 (Mouse) 

Species Rats and Mouse 

Method 

Results 

NOAEL 9.5 mg/kg bw/day (rat); 17.2 mg/kg bw/day (Mouse) 

NOEL 

Reference/Comments/ 

Justification for missing 

data 

MEPC 56/2, paragraph 2.3.4.2 

2.6 Development and Reproductive Toxicity 

2.6.1 A summary of the development and reproductive toxicity data evaluated by the Group is 

shown in the table below. 
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Exposure Route Oral 

Exposure Duration 66-76 days 

Exposure dose 0-10mg/kg/day 

Species Rat 

Method 

Results 

NOAEL 10mg/kg/day 

NOEL 

Reference/Comments/ 

Justification for missing 

data 

MEPC 56/2, paragraph 2.3.5.2 

2.7 Carcinogenicity/Mutagenicity

2.7.1 A summary of the carcinogenicity and mutagenicity data evaluated by the Group is 

shown in the table below. 

 Species Method Details Results 

Reference/Comments/ 

Justification for missing 

data 

Carcinogenicity Not 

carcinogenic 

IARC Group D 

(MEPC 56/2, 

paragraph 2.3.6.2) 

Mutagenicity Mouse 

Micronucleus assay. 

Chromosomal 

aberration test 

Not 

mutagenic 

MEPC 56/2, 

paragraph 2.3.6.2) 

2.8 Toxicokinetics

3 ENVIRONMENTAL EFFECTS AND FATE 

3.1 Acute aquatic toxicity 

3.1.1 The table below summarizes the evaluation of the acute aquatic toxicity of 

monochloramine. 

F 

C 

A 

Species Effect Value Reference/Comments/ 

Justification for missing data 

F Oncorhynchus kisutch 96h LC50 0.079 mg/l 

C Gammarus 

pseudolimnaeus 96h LC50 0.22 mg/l 

A Missing 

MEPC 56/2, paragraph 2.2.1.2 

F = Fish, C = Crustacea, A = Algae 

3.2 Chronic Aquatic toxicity 

3.2.1 The Group noted that there were no available data on the chronic aquatic toxicity of 

monochloramine. 
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3.3 Information on Endocrine Disruption 

3.3.1 The Group noted that there was no information related to the potential endocrine 

disruption effect of monochloramine. 

3.4 Sediment Toxicity

3.4.1 The Group agreed with the view of the applicant that, due to the low Koc (see 3.7), 

monochloramine was unlikely to be adsorbed into the sediment sufficiently to cause any adverse 

effects in that compartment. 

3.5 Bioavailability/Biomagnification/Bioconcentration 

3.5.1 A summary of the pertinent data related to bioavailability, biomagnification and 

bioconcentration for monochloramine is shown in the table below. 

 Log Pow BCF Reference 

monochloramine -1.19 MEPC 56/2, paragraph 2.2.5.2 

3.6 Food Web/Population Effects 

3.6.1 The Group agreed with the view of the applicant that, due to the low Log Pow of 

monochloramine, it was unlikely to accumulate in the food chain. 

3.7 Environmental Fate 

3.7.1 The Group noted that no information has been provided on the degradation of 

monochloramine whilst the sorption of monochloramine was estimated using a QSAR (EPI 

Suite). It was concluded that these data are sufficient to estimate the rapid removal of 

monochloramine from seawater if discharde. 

* * * 
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Appendix 3 

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF TRIBROMOMETHANE 

1 PHYSICOCHEMICAL PROPERTIES

1.1 The Group noted that there were no physical properties provided for tribromomethane 

(bromoform), although some data could be retrieved from other sources as shown in the table. 

Molecular formula CHBr3

Molecular weight 253.73 

CAS-number 75-25-2 

Appearance Colourless to yellow liquid 

Density (air = 1) 8.7 

Vapour pressure (Pa) @ 20 oC 665 

Water Solubility (mg/L) Slightly 

Melting Point (°C) 9 

Boiling Point (°C) 150 

2 MAMMALIAN TOXICITY 

2.1 Acute mammalian toxicity

2.1.1 A summary of the acute mammalian toxicity data for tribromomethane, evaluated by the 

Group, is summarized in the table below. 

 

Exposure Route Value Species Reference 

Oral LD50 (mg/kg) 1147 Rat MEPC 56/2, 

paragraph 2.3.1.2 

Dermal LD50 (mg/kg) Missing 

Inhalation LC50 (mg/l/4h) <7000ppm/1h Dog MEPC 56/2, 

paragraph 2.3.2.2 

 Sub-acute toxicity

NOAEL oral (mg/kg 

bw/day) 2 weeks 

 Missing 

2.2 Corrosion/Irritation

2.2.1 A summary of the corrosion/irritation data for tribromothane evaluated by the Group is 

summarized in the table below. 
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 Species Method Results 

(including 

scores where 

available) 

Reference/Comments/Justification 

for missing data 

Skin Rabbit Moderately 

irritating 

Eye Rabbit Moderately 

irritating 

Respiratory 

system 

 Moderately 

irritating 

MEPC 56/2, paragraph 2.3.2.2 

2.3 Sensitization

2.3.1 The Group noted that no sensitization data were reported for tribromomethane. 

2.4 Repeated dose toxicity

2.4.1 A summary of the repeated dose toxicity data for tribromomethane, evaluated by the 

Group is shown in the table below. 

Exposure Route Oral 

Exposure Duration 13 weeks 

Exposure dose 50 mg/kg/day 

Species Rat 

Method 

Results 

NOAEL 25 mg/kg/d 

NOEL 

Reference/Comments/ 

Justification for missing 

data 

MEPC 56/2, paragraph 2.3.3.2 

2.5 Chronic and long-term toxicity 

2.5.1 A summary of the data evaluated by the Group for tribromomethane, is shown in the table 

below. 

Exposure Route 1 year 

Exposure Duration 

Exposure dose 6.2-57 mg/kg/d (Rat) 

8.3-73 mg/kg/d (Mouse) 

Species Rat and Mouse 

Method 

Results 

NOAEL <6.2 mg/kg/d 

NOEL <6.2 mg/kg/d 

Reference/Comments/ 

Justification for missing 

data 

MEPC 56/2, paragraph 2.3.4.2 
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2.6 Development and Reproductive Toxicity 

2.6.1 A summary of the development and reproductive toxicity data evaluated by the Group for 

tribromomethane is shown in the table below. 

Exposure Route 

Exposure Duration Not given for rat study 

105 d for Mouse study 

Exposure dose 50-200 mg/kg 

Species Rat and Mouse 

Method 

Results foetotoxicity observed in rats 

No fertility effects seen in Mouse study 

NOAEL ? 

NOEL ? 

Reference/Comments/ 

Justification for missing 

data 

MEPC 56/2, paragraph 2.3.5.2 

2.7 Carcinogenicity/Mutagenicity

2.7.1 A summary of the carcinogenicity and mutagenicity data evaluated by the Group for 

tribromomethane is shown in the table below. 

 Species Method 

Details 

Results Reference/Comments/ 

Justification for missing 

data 

Carcinogenicity Human Probable 

Human 

Carcinogen 

U.S. EPA (IRIS) 

MEPC 56/2, 

paragraph 2.3.6.2 

Mutagenicity Salmonella. 

Mammalian 

cells 

Ames test Mixed 

Mixed 

MEPC 56/2, 

paragraph 2.3.7.2 

2.7.2 As the mutagenicity data reported were variable, the Group could not come to a 

conclusion regarding the mutagenicity potential of tribromomethane 

2.8 Toxicokinetics

3 ENVIRONMENTAL EFFECTS 

3.1 Acute aquatic toxicity 

3.1.1 The table below summarizes the evaluation of the acute aquatic toxicity for 

tribromomethane. 
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F 

C 

A 

Species Effect Value 

(mg/L) 

Calculated 

NOEC 

(mg/L) 

Reference/Comments 

F Cyprinodon variegatus 96h LC50 7.1 2.9 

C Daphnia magna 24-48h LC50 46 <7.8 

A Skeletonema costatum 96h EC50 12.3 

MEPC 56/2, 

paragraph 2.2.1.2 

 F = Fish, C = Crustacea, A = Algae 

3.2 Chronic Aquatic toxicity 

F 

C 

A 

Species Effect Value 

Reference/Comments 

F Cyprinodon variegatus 28d NOEC 4.8mg/l 

C 

A 

MEPC 56/2, 

paragraph 2.2.2.2 

3.3 Information on Endocrine Disruption 

3.3.1 The Group noted that there were no available data on the chronic aquatic toxicity of 

tribromomethane. 

3.4 Sediment Toxicity

3.4.1 The Group agreed with the view of the applicant that, due to its low Koc value, 

tribromomethane was unlikely to be adsorbed into the sediment sufficiently to cause any adverse 

effects in that compartment. 

3.5 Bioavailability/Biomagnification/Bioconcentration 

3.5.1 A summary of the pertinent data related to the bioavailability, biomagnification and 

bioconcentration of tribromomethane is shown in the table below. 

 Log Pow BCF Reference 

CHBr3 2.4 MEPC 56/2, 

paragraph 2.2.4.2

3.5.2 Based on this information the Group concluded that bromoform was not a 

bioaccumulating substance. 

3.6 Food Web/Population Effects 

3.6.1 The Group agreed with the view of the applicant that, due to the low Log Pow of 

tribromomethane, it was unlikely to accumulate in the food chain. 

3.7 Environmental Fate 

3.7.1 In the following table an overview is given of the environmental fate and behaviour data 

of bromoform. 
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Hydrolysis 686 y 

pH5 (seawater) 

pH7 (seawater) 

pH9 (seawater) 

Photolysis NA 

Degradation in seawater NA 

Ready biodegradation NA 

Biodegradation Water: 38 d 

Soil: 75 d 

Sediment: 340 d 

Air: 380 d 

Sorption (Koc) (dm3/kg) 114.8 (62 ñ 126) 

Bioconcentration 14 

Anaerobic degradation 21 ñ 42 d 

 NA = not available or not applicable 

3.7.2 The fate data on bromoform indicate that it is not clear on beforehand that there is no risk 

to the environment because of low exposures. Due to the half lives of around 50 d substantial 

levels of bromoform may still occur after discharge of the ballast water into the receiving 

environment. 

3.7.3 Therefore the Predicted Environmental Concentration (PEC) was calculated at the 

moment of discharge and after 28 days, being the duration of the chronic toxicity study with 

Cyprinodon variegatus. 

* * * 
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Appendix 4 

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF 

DIBROMOCHLOROMETHANE 

1 PHYSICOCHEMICAL PROPERTIES

1.1 The Group noted that there were not any physical properties provided for 

dibromochloromethane. However, the Group was able to draw some properties from other 

sources. An overview is provide din the table below. 

Molecular formula CHClBr2

Molecular weight 208.28 

CAS-number 124-48-1 

Appearance Colourless to yellow liquid 

Density (air = 1) 2.451 

Vapour pressure (Pa) @ 20 oC NA 

Water Solubility (mg/L) Slightly 

Melting Point (°C) < - 20 

Boiling Point (°C) 119 ñ 120 

2 MAMMALIAN TOXICITY 

2.1 Acute mammalian toxicity

2.1.1 The data available to the Group for dibromochloromethane are summarized in the table 

below. 

 

Exposure Route Value Species Reference 

Oral LD50 (mg/kg) 800 Mouse MEPC 56/2, paragraph 2.3.1.2 

Dermal LD50 (mg/kg) Missing 

Inhalation LC50 (mg/l/4h) Missing 

2.2 Corrosion/Irritation

2.2.1 A summary of the available corrosion/irritation data for dibromochloromethane is shown 

in the table below. 

 Species Method Results 

(including scores 

where available) 

Reference/Comments/Justification 

for missing data

Skin Irritating MEPC 56/2, paragraph 2.3.2.2 

Eye Irritating MEPC 56/2, paragraph 2.3.2.2 

Lung Irritating MEPC 56/2, paragraph 2.3.2.2 
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2.3 Sensitization

2.3.1 The Group noted that no data had been provided on the sensitization potential of 

dibromochloromethane. 

2.4 Repeated dose toxicity

2.4.1 A summary of the available repeated dose toxicity data for dibromochloromethane is 

shown in the table below. 

Exposure Route Oral 

Exposure Duration 90 days 

Exposure dose 0-200mg/kg/d 

Species Rat 

Method 

Results Decrease in body weight at 200mg/kg/d 

NOAEL 50mg/kg/d 

NOEL 

Reference/Comments/ 

Justification for missing 

data 

MEPC 56/2 para. 2.3.3.2 

2.5 Chronic and long-term toxicity 

2.5.1 A summary of the chronic and long-term toxicity data for dibromochloromethane is 

shown in the table below. 

Exposure Route Oral 

Exposure Duration ? 

Exposure dose 0-100mg/kg/d 

Species Rat and Mouse 

Method 

Results Liver lesions seen in all test groups 

Liver necrosis and calcification seen at 100mg/kg/d female Mouse 

NOAEL 

NOEL Not reported 

Reference/Comments/ 

Justification for missing 

data 

2.6 Development and Reproductive Toxicity 

2.6.1 A summary of the development and reproductive toxicity data for dibromochloromethane 

is shown in the table below. 
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Exposure Route Oral 

Exposure Duration 2-generations 

Exposure dose 0-4mg/l 

Species Mouse 

Method 

Results At 4mg/l decreased fertility and gestational index in F1 generation. 

At 4mg/l only decreased fertility in F2 generation. 

No dominant lethal or teratogenic effects observed. 

NOAEL Not reported 

NOEL Not reported 

Reference/Comments/ 

Justification for missing 

data 

MEPC 56/2, paragraph 2.3.5.2 

2.7 Carcinogenicity/Mutagenicity

2.7.1 A summary of the carcinogenicity and mutagenicity data for dibromochloromethane is 

shown in the table below. 

 Species Method 

Details 

Results Reference/Comments/ 

Justification for missing 

data 

Carcinogenicity Human Probable human 

carcinogen 

U.S. EPA (IRIS) 

MEPC 56/2, 

paragraph 2.3.6.2 

Mutagenicity Salmonella 

typhimurium 

Ames +ve and -ve results MEPC 56/2, 

paragraph 2.3.7.2 

2.8 Toxicokinetics

3 ENVIRONMENTAL EFFECTS AND FATE 

3.1 Acute aquatic toxicity 

3.1.1 The table below summarizes the evaluation of the acute aquatic toxicity of 

dibromochloromethane. 

F 

C 

A 

Species Effect Value 

Reference/Comments 

F Oryzia latipes 96h LC50 79mg/l 

C Daphnia magna 48h EC50 27mg/l 

A Selenastrum capricornutum 72h EC50 

72h NOEC 

6.1mg/l 

2.9mg/l 

MEPC 56/2, 

paragraph 2.2.1.2 

F = Fish, C = Crustacea, A = Algae 
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3.2 Chronic Aquatic toxicity 

3.2.1 The Group noted that no chronic aquatic toxicity data had been reported on 

dibromochloromethane. 

3.3 Information on Endocrine Disruption 

3.3.1 The Group noted that there was no information related to the potential endocrine 

disruption effect of dibromochloromethane. 

3.4 Sediment Toxicity

3.4.1 The Group agreed with the view of the applicant that, due to its low Koc value, 

dibromochloromethane was unlikely to be adsorbed in the sediment sufficiently to cause any 

adverse effects in that compartment. 

3.5 Bioavailability/Biomagnification/Bioconcentration 

3.5.1 A summary of the pertinent data related to bioavailability, biomagnification and 

bioconcentration for dibromochloromethane is shown in the table below. 

Log Pow BCF Reference 

2.16 MEPC 56/2, 

paragraph 2.2.5.2 

Based on this value the Group does not consider dibromochloromethane to be a bioaccumulative 

substance. 

3.6 Food Web/Population Effects 

3.6.1 The Group agreed with the view of the applicant that, due to the low Log Pow of 

dibromochloromethane, it was unlikely to accumulate in the food chain. 

3.7 Environmental Fate 

3.7.1 The main process taking place if the substance has been released to surface water is 

volatilisation. This process will typically occur with a half life of 46 hours and a range of 43 min 

to 16.6 d. The sorption constant of the substance is established at Koc = 84 l/kg. 

3.7.2 Based on these values the substance may be of concern in the risk evaluation. 

* * * 
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Appendix 5 

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES 

OF 2,2-DIBROMOACETIC ACID 

1 PHYSICOCHEMICAL PROPERTIES

1.1 The Group noted that there were not any physical properties provided 

for 2,2-dibromoacetic acid. 

2 MAMMALIAN TOXICITY 

2.1 Acute mammalian toxicity

2.1.1 The data available to the Group on the acute toxicity of 2,2-dibromoacetic acid are 

summarized in the table below. 

 

Exposure Route Value Species Reference 

Oral LD50 (mg/kg) 1737 Rat MEPC 56/2, paragraph 2.3.1.2 

Dermal LD50 (mg/kg) Missing 

Inhalation LC50 (mg/l/4h) Missing 

2.2 Corrosion/Irritation

2.2.1 A summary of the available corrosion/irritation data for is shown in the table below. 

 Species Method Results 

(including scores 

where available) 

Reference/Comments/Justification 

for missing data

Skin Corrosive 

Eye Severe 

Lung Severe 

Assumed as a strong acid 

2.3 Sensitization

2.3.1 The Group noted that there were no data related to the sensitization potential 

of 2,2-dibromoacetic acid. 

2.4 Repeated dose toxicity

2.4.1 A summary of the available repeated dose toxicity data for 2,2-dibromoacetic acid is 

shown in the table below. 
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Exposure Route Oral Oral 

Exposure Duration 28d 3 months 

Exposure dose 0-2000mg/l 

Species Mouse Mouse 

Method 

Results No deaths but various effects seen at 

>500m/l 

NOAEL 38mg/kg/d Not reported 

NOEL Not reported 

Reference/Comments/ 

Justification for missing 

data 

MEPC 56/2, paragraph 2.3.3.2 

2.5 Chronic and long-term toxicity 

2.5.1 A summary of the available chronic and long-term toxicity data for 2,2-dibromoacetic 

acid is shown in the table below. 

Exposure Route Oral Oral 

Exposure Duration 2 years 2 years 

Exposure dose 0-1000mg/l 

Species Mouse Rat 

Method 

Results Increased body weights at 50 and 

500mg/l in males only 

Decrease body weights at 500 

and 1000mg/l 

NOAEL Not reported Not reported 

NOEL Not reported Not reported 

Reference/Comments/ 

Justification for missing 

data 

MEPC 56/2, paragraph 2.3.4.2 

2.6 Development and Reproductive Toxicity 

2.6.1 A summary of the available development and reproductive toxicity data 

for 2,2-dibromoacetic acid is shown in the table below. 

Exposure Route Oral 

Exposure Duration 

Exposure dose 0-250 mg/kg/d 

Species Rat 

Method 

Results Increased E2 at 250 mg/kg/d 

NOAEL 125 mg/kg/d 

NOEL 

Reference/Comments/ 

Justification for missing 

data 

MEPC 56/2, paragraph 2.3.5.2 
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2.7 Carcinogenicity/Mutagenicity

2.7.1 A summary of the available carcinogenicity and mutagenicity data for 2,2-dibromoacetic 

acid is shown in the table below.

 Species Method 

Details 

Results Reference/Comments/ 

Justification for 

missing data 

Carcinogenicity Mouse and 

rat 

 Carcinogenic 

(tumours/cancers 

observed) 

MEPC 56/2, 

paragraph 2.3.6.2 

Mutagenicity Salmonella 

typhimurium 

Ames 

test 

Positive at 10mg/l MEPC 56/2, 

paragraph 2.3.7.2 

2.8 Toxicokinetics

3 ENVIRONMENTAL EFFECTS AND FATE 

3.1 Acute aquatic toxicity 

3.1.1 The table below summarizes the evaluation of the acute aquatic toxicity 

of 2,2-dibromoacetic acid.

F 

C 

A 

Species Effect Value 

Reference/Comments 

F Pimephales promelas 96h LC50 6.9 mg/l MEPC 56/2, paragraph 2.2.1.2 

C Missing 

A Missing 

 F = Fish, C = Crustacea, A = Algae 

3.2 Chronic Aquatic toxicity 

3.2.1 The Group noted that there were not available data on the chronic aquatic toxicity 

of 2,2-dibromoacetic acid. 

3.3 Information on Endocrine Disruption 

3.3.1 The Group noted that there was no information related to the potential endocrine 

disruption effect of 2,2-dibromoacetic acid. 

3.4 Sediment Toxicity

3.4.1 The Group agreed with the view of the applicant that, due to its low 

Koc value, 2,2-dibromoacetic acid was unlikely to be adsorbed into the sediment sufficiently to 

cause any adverse effects in that compartment. 
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3.5 Bioavailability/Biomagnification/Bioconcentration 

3.5.1 A summary of the pertinent data related to bioavailability, biomagnification and 

bioconcentration is shown in the table below

Log Pow BCF Reference 

1.22 MEPC 56/2, 

paragraph 2.2.5.2 

3.5.2 Based on this value the Group does not consider the substance to be bioaccumulative. 

3.6 Food Web/Population Effects 

3.6.1 The Group agreed with the view of the applicant that, due to the low Log Pow 

of 2,2-dibromoacetic acid, it was unlikely to accumulate in the food chain. 

3.7 Environmental Fate 

3.7.1 No information is provided on the degradation of 2,2-dibromoacetic acid. The Group was 

also not able to find any data on this item. A sorption constant was available of Koc = 1.9 l/kg. 

* * * 
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Appendix 6 

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES 

OF 2,2,2-TRIBROMOACETIC ACID 

1 PHYSICOCHEMICAL PROPERTIES

1.1 The Group noted that there were not any physical properties provided 

for 2,2,2-tribromoacetic acid. 

2 MAMMALIAN TOXICITY 

2.1 Acute mammalian toxicity

2.1.1 The Group noted that there were no acute mammalian toxicity data for this chemical. 

2.2 Corrosion/Irritation

2.2.1 A summary of the available corrosion/irritation data for: 

 Species Method Results 

(including scores 

where available) 

Reference/Comments/Justification 

for missing data

Skin Corrosive 

Eye Severe 

Lungs Severe 

Assumed because a strong acid 

2.3 Sensitization

2.3.1 The Group noted that there were no data related to the sensitization potential of this 

chemical. 

2.4 Repeated dose toxicity

2.4.1 The Group noted that there were no data related to the repeated dose toxicity of this 

chemical. 

2.5 Chronic and long-term toxicity 

2.5.1 The Group noted that there were no data related to the chronic and long-term toxicity of 

this chemical. 

2.6 Development and Reproductive Toxicity 

2.6.1 The Group noted that there were no data related to the development and reproductive 

toxicity of this chemical. 
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2.7 Carcinogenicity/Mutagenicity

2.7 A summary of the evaluated carcinogenicity and mutagenicity data is shown in the table 

below. 

 Species Method 

Details 

Results Reference/Comments/ 

Justification for 

missing data 

Carcinogenicity Missing 

Mutagenicity Salmonella 

typhimurium 

Ames 

test 

mutagenicity seen at 

2000mg/l 

Inconclusive in relation 

to humans 

2.8 Toxicokinetics

3 ENVIRONMENTAL EFFECTS AND FATE 

3.1 Acute aquatic toxicity 

3.1.1 The Group noted that there were no acute aquatic toxicity data available for this chemical. 

3.2 Chronic Aquatic toxicity 

3.2.1 The Group noted that there were no chronic aquatic toxicity data available for this 

chemical. 

3.3 Information on Endocrine Disruption 

3.3.1 The Group noted that there was no information related to the endocrine disruption 

potential for this chemical. 

3.4 Sediment Toxicity

3.4.1 The Group agreed with the view of the applicant that, due to its low Koc value, this 

chemical was unlikely to be adsorbed into the sediment sufficiently to cause any adverse effects 

in that compartment. 

3.5 Bioavailability/Biomagnification/Bioconcentration 

3.5.1 A summary of the pertinent data related to bioavailability, biomagnification and 

bioconcentration for: 

Log Pow BCF Koc Calculated 

Environmental 

Distribution 

Ratio 

1⁄2 life Reference 

2.07 2.741 l/kg 0.0715% MEPC 56/2, 

paragraph 2.2.5.2 
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3.6 Food Web/Population Effects 

3.6.1 The Group agreed with the view of the applicant that, due to the low Log Pow of this 

chemical, it was unlikely to accumulate in the food chain. 

3.7 Environmental Fate 

3.7.1 The group noted that no data were available in the notifying dossier on degradation of this 

substance. A sorption value of Koc = 2.741 l/kg was presented. 

* * * 
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Appendix 7 

AQUATIC TOXICITY DATA FOR TREATED BALLAST WATER 

1 Introduction 

1.1 The Group recognized that it was inappropriate to provide data on the physical properties 

of treated ballast water and agreed that it was unnecessary to provide mammalian toxicity data 

either. 

2 Chronic Aquatic Toxicity Data

2.1 A summary of the chronic toxicity data from the testing of treated ballast water is shown 

in the table below. 

Dilution (v/v) required to 

observe the effect 

F 

C 

A Species Exposure 

Duration NOEC LOEC 

Reference/Comments 

F Oryzia javanicus 40 days 10% 31% 

C Hyale barbicornis 21 days 10% 31% 

A Skeletonema 

costatum 72 hrs 3.1% 10% 

MEPC 56/2, 

paragraph 5.2.3 

The starting point was a concentration of 50 mg FAC/L. 

***

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ANNEX 8 

TIMETABLE FOR ACTIVITIES RELATED TO THE 4TH MEETING 

OF THE GESAMP-BWWG

Date Activity 

31 August 2007 Deadline for submission of application dossiers and related 

documents to be reviewed by GESAMP-BWWG (4). 

31 August 2007 ñ 26 October 

2007 

Preparation of the meeting, including circulation of any 

relevant information provided by other delegations. 

29 October ñ 2 November 2007 4th Meeting of the GESAMP-BWWG. 

5-9 November 2007 Editing and completion of the draft report of the 4th meeting. 

12-18 November 2007 Administrations confirm that no confidential data are 

contained in the report. 

19 November ñ 14 December 

2007 

Review and approval of the report by GESAMP. 

17-21 December 2007 Produce the final report addressing the comments by 

GESAMP. 

21 December 2007 Submission of the report on the 4th meeting of 

GESAMP-BWWG in accordance with the 13 weeks deadline 

for MEPC 57 documents. 

***

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ANNEX 9 

GESAMP BWWG ñ HUMAN EXPOSURE ASSESSMENT 

1 INTRODUCTION 

1.1 In risk assessment for human health, the normal procedure is to compare the exposure 

levels to which the population is exposed or likely to be exposed with those levels at which no 

toxic effects are expected to occur. 

1.2 There are normally four stages when carrying a quantitative risk assessment: 

 .1 Hazard identification ñ what are the substances of concern and what are their 

effects. 

 .2 Dose (concentration) ñ response (effect) relation ñ what is the relationship 

between the dose and either the severity or the frequency of the effect. 

 .3 Exposure assessment ñ what is the intensity, and the duration or frequency of 

exposure to an agent. 

 .4 Risk characterisation ñ how to quantify the risk from the above data. 

1.2 The greatest part of information about the potential human toxic effects of chemical 

substances is obtained from studies on animals. 

1.3 In assessing an acceptable level of a particular substance, the procedure usually follows 

moving from an experiment database of animal or preferably human data (e.g. epidemiological 

studies) giving a No Observed Adverse Effect Level (NOAEL) or a Lowest Observed Adverse 

Effect Level (LOAEL) to deriving exposure limit at a lower exposure value, to allow for the 

uncertainties in the data. Comparison of this exposure limit with a measured or estimated 

exposure level is then used to judge whether the situation is satisfactory or whether risk 

management measures are required. 

2 The Margin of Safety (MOS) or Margin of Exposure (MOE) Approach 

2.1 In this procedure the ratio of NOAEL determined in the animal studies and expressed in 

mg/kg/day is compared with the level to which a human may be exposed: 

 MOS or MOE = NOAEL mg/kg/d

 Exposure mg/kg/d 

2.2 Assuming that the exposure of a human population to a substance in drinking water 

is 1 mg/L, for 60 kg woman consuming on average 2 L of water/day, then: 

 Exposure= 1mg/L x 2 L/day = 0.03 mg/kg/day 

 60 kg 
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2.3 The next step in the MOS approach is to derive and apply a so-called ìreference MOSî 

(MOSref). The MOSref is an overall assessment factor (AF) addressing differences between 

animal experimental data and real human exposure situation, taking into account variability and 

uncertainty. Normally, the value for each AF is based on substance-specific information or, 

if missing, on default values. It is common in Human Risk Assessment to use an MOSref 

of 100 (10 for interspecies variability ñ between animals and humans ñ and 10 for intraspecies 

variability ñ among humans). 

2.4 Example: taking into account the exposure value referred in 2.2. (0.03mg/kg/day) and, 

for instances, a NOAEL for developmental toxicity of 100 mg/kg/day, the MOS will be 100/0.03, 

i.e. 3333, a reassuring large value comparing to MOSref (100). However, if this value was much 

lower or lower than MOSref, it would indicate an inadequate MOS value over the NOAEL and a 

unacceptable human risk towards this adverse effect. 

2.5 The selection of the critical NOAEL for RA will depend on the extent, duration and 

route of human exposure and the selection of the most critical adverse effect. 

3 EXPOSURE ASSESSMENT 

3.1 The aim of assessing human exposure is to obtain a realistic estimate of total human 

exposure, expressed in terms of dose per unit weight, e.g. mg/kg. 

3.2 In principle, the exposure of a human population could be assessed by representative 

monitoring data and/or model calculations based on available information on substances with 

analogous uses and exposure patterns or properties. 

3.3 The predictions of exposure levels should describe a reasonable worst case situation, 

covering normal use patterns and where general public or workers may be exposed to the same 

substance. It is important to assess the reliability and the representativeness of the exposure 

measurements. 

3.4 Where data are of an unsatisfactory quality, it is useful to conduct an assessment using 

ìworst caseî assumptions. If this indicates a risk of no concern, the assessment needs no further 

refinement. 

3.5 The most probable scenarios for human exposure to BWMS still need to be properly 

identified. However, one can assume two potential groups, with some characteristics of each and 

expected route of exposure as follows: 

 .1 Crew (exposed occupationally): 

 .1.1 exposure assumed during working week ñ 8h day, 5 days per week; 

 .1.2 relatively healthy part of general population; and 

 .1.3 exposure routes: normally inhalation and dermal. 

 .2 General public/Human exposure via environment ñ users of coastal amenities, 

beach coastlines and offshore installations and harbours: 

 .2.1 exposure intermittent ñ needs to be estimated; 
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 .2.2 exposures may not be controlled; 

 .2.3 exposure routes: oral, inhalation and/or dermal; and 

 .2.4 includes vulnerable groups e.g. children and elderly people. 

3.6 Normally occupational exposure will be an external exposure, i.e. the amount in contact 

with the skin, inhaled, or the concentration in the atmosphere. Where the conclusion is that this 

level ìis of concernî, it may be necessary to determine internal exposure, i.e. the amount taken 

into the tissues of the body, or its bioavailability. 

3.7 The predictions of the consequences of exposure have to be carried out for each exposed 

human population (e.g. workers, general public) and for each effect. 

4 OCCUPATIONAL EXPOSURE 

4.1 The most common routes of exposure in the workplace are by inhalation or by absorption 

through intact skin. Dermal exposure may also result in local effects, such as irritation or 

dermatitis. 

4.2 Exposure should always be assessed in the first instance for the unprotected worker and, 

if appropriate, a second assessment, should be made taking PPE (personal protective equipment) 

into account. 

4.3 Of primary importance in developing the assessment of occupational exposure is a full 

understanding of the processes and unit operations in which exposure occurs, and of the actual 

work activities resulting in exposure. With this background knowledge, the following questions 

have to be answered: 

 .1 what is the population of potentially exposed individuals? 

 .2 what are the magnitude, frequency and duration of inhalation and dermal 

exposures? 

 .3 what personal protective equipment and control measures are used to reduce or 

mitigate exposure? and 

 .4 how effective are they in reducing exposure? 

4.4 The overall assessment of each type of exposure should be repeated for all the various 

production processes and uses made for the chosen chemical, and from a knowledge of the 

frequency and duration of exposure the ìworst caseî highlighted. 

4.5 If ìrealî data are missing for a chosen substance, as an alternative to modelling it may be 

possible to substitute data from another chemical with a similar pattern of exposure. 
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4.6 The following major factors can affect exposure potential: 

 .1 size of activity ñ the greater the quantity of the substance involved or the higher 

the concentration in solution, the greater the potential for exposure is likely to be. 

Any potential hazard from 10 tons is likely to be much greater than that of 10 mg; 

 .2 physical characteristics of the activity ñ particle size of a solid or volatility of a 

liquid are also likely to affect the exposure, as is the presence of barriers to the 

exposure and containment of the substance away from human contact. Procedures 

involving elevated temperature, particularly with substances with significant 

vapour pressures, may engender an enhanced inhalation exposure; and 

 .3 time of exposure ñ the duration and frequency of exposure to an activity will also 

be a factor ñ the longer the time of exposure the higher the exposure potential. 

4.7 The quantitative human exposure assessment results in a reasonable worst-case estimate 

for external exposure via the inhalation and dermal route (the main routes of concern for 

occupational exposure) that are taken forward to the risk characterization. 

4.8 These estimates are obtained for all relevant scenarios that have been identified taking 

into account all relevant available information. 

4.9 In the risk characterisation phase these estimates are combined with the results of the 

effects assessment and conclusions are drawn whether or not there is a concern for any scenarios 

assessed. 

5 CONTROL OF THE RISK 

5.1 When a risk assessment results in the conclusion that the risk is too high, consideration 

has to be given to introducing the following controls that will lower this risk to acceptable levels: 

 .1 prevention that includes: 

.1.1 elimination; 

.1.2 substitution; and 

 .1.3 good hygiene practice. 

 .2 Physical segregation that includes: 

 .2.1 complete enclosure with extraction; 

 .2.2 local exhaust ventilation with or without partial enclosure; and 

 .2.3 screening. 

 
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.3 Personal protection that includes: 

 .3.1 respiratory protective equipment including respirators and self-contained 

breathing apparatus; and 

 .3.2 protective clothing (eye and head protection, gloves, shoes, etc.). 

6 REFERENCES 

 .1 Chemical Risk Assessment ñ UNEP/IPCS, WHO, 1999; and 

 .2 Technical Guidance Document on Risk Assessment, European Chemicals Bureau 

(ECB) ñ Part I, European Communities, 2003. 

____________