I:\MEPC\57\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 

57th session 

Agenda item 2 

MEPC 57/2

 19 December 2007

 Original: ENGLISH

HARMFUL AQUATIC ORGANISMS IN BALLAST WATER 

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

(GESAMP-BWWG) 

Note by the Secretariat 

SUMMARY

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

GESAMP Ballast Water Working Group (GESAMP-BWWG) and 

includes the evaluation of proposals submitted for approval by the 

Republic of Korea, Japan and Germany 

Action to be taken: Paragraph 4 

Related document: GESAMP-BWWG 4/9 (attached) 

Introduction

1 The fourth meeting of the GESAMP-BWWG was held at IMO’s temporary headquarters 

from 5 to 9 November 2007 and its report is attached to this document as GESAMP-BWWG 4/9. 

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

ballast water management systems (BWMS) 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 4, 5 and 6 of the attached report. 

3 A proposal submitted by South Africa was deferred to the next meeting of 

the GESAMP-BWWG in January 2008 due to time constraints and will be given priority 

at that meeting. 

Action requested of the Committee

4 The Committee is invited to: 

 .1 endorse the Group’s proposal (paragraph 7.1)∗

 to introduce a questionnaire to 

facilitate the description of the BWMS as a set of unit operations and system 

components describing the individual potential of each system 

component/operation for human exposure and identifying the respective Risk 

Management Measures. Such a questionnaire should be introduced as part of the 

 

∗

 Paragraphs referred to in this section are those of GESAMP-BWWG 4/9. 
MEPC 57/2 - 2 - 

I:\MEPC\57\2.doc 

further development of a Human Exposure Scenario to assist manufacturers in 

preparing their applications for approval of BWMS; 

 .2 endorse the view that further guidance on selecting the appropriate Assessment 

Factors (AF) is needed when only two chronic NOECs are available for use in the 

marine risk assessment (paragraph 7.2.1) and agree that if chronic tests included 

the most sensitive organism from the acute set of three tests, then an Assessment 

Factor (AF) of 100 could be used on a case by case basis. If the most sensitive 

group is not included, then an AF of 1000 should be applied (paragraph 7.2.2); 

 .3 agree to include the description of the Final Approval process contained in 

paragraph 7.2.3 in its Methodology for information gathering and conduct of work 

(the Methodology); 

 .4 agree to add to the Methodology the provisions related to Human Exposure 

Scenarios contained in annex 9 of the GESAMP-BWWG third meeting report 

(document GESAMP-BWWG 3/9) together with the clarifications regarding 

occupational exposure and the questionnaire referred to in paragraphs 7.1.2 

to 7.1.8 described above (paragraph 7.2.4); 

 .5 agree that Final Approval should not be granted to the Electro Clean System as 

reported by the Republic of Korea in MEPC 57/2/1 (see annex 4 of the 

current report); 

 .6 agree that Basic Approval should be granted to the Clear ballast System as 

reported by Japan in MEPC 57/2/2 (see annex 5 of the current report); 

 .7 agree that Final Approval should not be granted to the CleanBallast! System as 

reported by Germany in MEPC 57/2/3 (see annex 6 of the current report); and 

 .8 approve the report in general. 

* * * 
I:\MEPC\57\2.doc 

GESAMP-BWWG 

4th session 

Agenda item 9 

GESAMP-BWWG 4/9

 28 December 2007

 Original: ENGLISH

REPORT OF THE FOURTH MEETING OF 

THE GESAMP-BALLAST WATER WORKING GROUP (GESAMP-BWWG) 

Table of Contents 

Section Page Nos. 

 

1 INTRODUCTION..................................................................... 2 

2 ISSUES OF CONFIDENTIALITY ........................................... 3 

3 OUTCOME OF MEPC 56...................................................... 3 

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

 5 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST 

WATER MANAGEMENT SYSTEMS ............................................ 5 

6 CONSIDERATION OF QUERIES REGARDING THE WORK 

OF THE GESAMP-BWWG .................................................... 5 

7 ANY OTHER BUSINESS................................................. 6 

8 TENTATIVE DATE FOR THE NEXT MEETING.................... 9 

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

ANNEXES

Annex 1 List of members who attended the fourth session of the GESAMP-BWWG 

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

Annex 3 Terms of reference for the Technical Group 

Annex 4 Review of the ‘Electro Clean’ system, submitted by the Republic of Korea for 

Final Approval 

Annex 5 Review of the ‘ClearBallast’ system (Hitachi), submitted by Japan for 

Basic Approval 

Annex 6 Review of the ‘CleanBallast!’ system, submitted by Germany for Final Approval 
GESAMP-BWWG 4/9 - 2 - 

I:\MEPC\57\2.doc 

1 INTRODUCTION 

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

held at IMO Headquarters, London, from 5 to 9 November 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 Mr. Miguel Palomares, Director of Marine Environment Division, informed the Group 

that seven proposals for approval had been submitted for consideration by MEPC 57 in 

accordance with the agreed deadline of 7 September 2007. Mr. Palomares expressed his 

appreciation for the effort made by the members of the GESAMP-BWWG to have an additional 

meeting before MEPC 57 in an attempt to evaluate all the seven submissions. He believed that 

this would assist in the development of new ballast water technologies and, consequently, 

alleviate the concerns of the shipping industry with regard to the availability of such 

technologies. 

1.3 Mr. Palomares informed the Group that, based on their kind agreement to have an 

additional meeting from 14 to 18 January 2008, arrangements had been made and the necessary 

approvals requested from the Chairman of the MEPC and the Secretary-General of the 

Organization. He also informed that further development of the Methodology for information 

gathering and conduct of work (the Methodology) would be postponed to the additional meeting 

in January 2008 to facilitate the evaluation of proposals during this meeting. He drew the 

attention of the Group of the importance of reviewing the various proposals in the chronological 

order of their submissions to ensure complete transparency and a fair treatment for all the 

proponent Member States. It should be noted in this context that the outcomes of 

GESAMP-BWWG (4) and (5) will both be reported to MEPC 57. Finally, Mr. Palomares 

expressed his appreciation for the effort made by Dr. Brigitte Behrends in preparing the first 

four proposals for evaluation by the Group and for liaising with the respective Member States to 

provide all the necessary data required for the evaluations. 

1.4 Mr. Dandu Pughiuc, Head of the Marine Biosafety Section, Marine Environment 

Division, welcomed the new members of the Group and wished them every success in their 

endeavors. He also reported on the contractual arrangements and informed the Group on the 

logistics of the meeting. He reminded the Group that, although MEPC 56 had agreed that the 

Methodology is a living document in need of further development, the Committee concluded 

that, as currently drafted, it provides the necessary technical guidance to conduct the evaluations. 

Mr. Pughiuc encouraged the members of the Group to focus on the submitted proposals at this 

session leaving the further development of the Methodology to the January 2008 meeting. 

1.5 Some members of the GESAMP-BWWG were of the view that additional discussion was 

necessary with regard to the development of a Human Exposure Scenario (HES) as approved by 

MEPC 56, in order to make the Final Approval process more efficient. Following a proposal by 

the Chairman, the Group agreed to increase the working hours to include this discussion under 

agenda item 7. 

1.6 Consideration of the ballast water management System (BWMS) proposal by 

South Africa contained in MEPC 56/2/3 was deferred to GESAMP-BWWG (5) in January 2008 

and having already been summarized by the IMO consultant will be considered first at 

that meeting. 
 - 3 - GESAMP-BWWG 4/9 

I:\MEPC\57\2.doc 

2 ISSUES OF CONFIDENTIALITY

2.1 Three proposals for approval of ballast water management systems submitted by the 

Republic of Korea (Final Approval), Japan (Basic Approval), Germany (Final Approval) have 

been reviewed at this meeting. The Secretariat informed the Group that the non-confidential parts 

of the submissions had been circulated as MEPC documents (MEPC 56/2/3 for South Africa; 

MEPC 57/2/1 for the Republic of Korea; MEPC 57/2/2 for Japan; and MEPC 57/2/3 for 

Germany) 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 also noted that the details of the functioning of the 

BWMS must be regarded as confidential to protect the rights of the manufacturer. The Group 

noted that the Organization, prior to submission of the Group’s evaluation report to the MEPC, 

would consult with the applicant of the proposed BWMS 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. 

2.4 Mr. Pughiuc reported on the conclusion of the Statement of Acceptance of Access to 

Confidential Information and reminded the Group members of the need to hand over any 

documents, drafts, or any other associated records and reports, for retention in confidence at the 

end of the meeting or when they are no longer necessary for the work of the Group. He also 

pointed out to the inventory lists prepared by the IMO Consultant for each submission and 

confirmed that all the folders received from the Member States concerned are made available to 

the Group. 

3 OUTCOME OF MEPC 56

3.1 A comprehensive introduction of the outcome of MEPC 56 was provided by the 

Secretariat (document GESAMP-BWWG 4/3). Particular emphasis was placed on the decisions 

of MEPC 56 related to the Draft Methodology for information gathering and method of work of 

the GESAMP-BWWG and the Group noted that MEPC 56 had endorsed its view that the 

GESAMP-BWWG Methodology is a living document in need of further development, but that it 

is currently suitable as technical guidance for use by applicants submitting requests for 

evaluation of BWMS. 

3.2 The Chairman of the GESAMP-BWWG reported on his participation at MEPC 56 and 

encouraged all the members to review the section regarding the ‘Action taken by the Committee’. 

He emphasized the complexity of the reporting process involving a number of very strict 

deadlines and the necessity to make each meeting as efficient and effective as possible. 

3.3 The Group noted that MEPC 56 had considered all of the issues, from the third session of 

the GESAMP-BWWG, which had been raised under paragraph 4 of MEPC 56/2/2. 
GESAMP-BWWG 4/9 - 4 - 

I:\MEPC\57\2.doc 

3.4 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. 

3.5 The Group noted that, as instructed by MEPC 56, the Secretariat had produced an updated 

version of the Methodology incorporating changes agreed at MEPC 56, in particular, replacing 

the mandatory wording by guidance document language. The Group agreed to further develop 

its Methodology at its next meeting in January 2008, concentrating on reviewing as many 

proposals as they can during this meeting. 

3.6 The Group agreed to encourage the MEPC to explore all the options to formalize the 

Methodology and reiterated the view that once a system has received Final Approval under 

Procedure (G9), the respective applicant should not be requested to submit additional information 

to meet any changes made to GESAMP-BWWG Methodology after the date of submission.

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 56, as contained in annex 3 of this report. 

4.2 The Group agreed to use the table below to determine the timetable for activities related 

to its regular meetings and, on a case-by-case basis, to decide on the timing of additional 

meetings as appropriate.

TIMETABLE FOR ACTIVITIES RELATED TO GESAMP-BWWG MEETINGS 

Timeline Activity 

28 weeks before MEPC Deadline for submission of application dossiers and related documents to 

be reviewed by GESAMP-BWWG 

(8 weeks) Preparation of the meeting, including circulation of any relevant 

information provided by other delegations 

20 weeks before MEPC GESAMP-BWWG Meeting 

(1 week) Editing and completion of the draft report of the meeting 

(1 week) Administrations confirm that no confidential data are contained in the 

report 

(3 weeks) Review and approval of the report by GESAMP 

(1 week) Produce the final report addressing the comments by GESAMP 

13 weeks before MEPC Submission of the report of the meeting of GESAMP-BWWG in 

accordance with the 13 weeks deadline for MEPC 
 - 5 - GESAMP-BWWG 4/9 

I:\MEPC\57\2.doc 

4.3 The Group noted that MEPC 58 will be held from 6 to 10 October 2008 and, using a time 

table similar to the one agreed by MEPC 56 and reproduced above, the Group agreed that the 

deadline for submission of application dossiers and related documents for MEPC 58 would 

be 21 March 2008. 

4.4 The Group agreed to further explore the possibility of extending the 28 week timeframe 

to 30 weeks, which would increase the flexibility of scheduling the meeting of the Group. 

The Group noted, however, that in even years when the MEPC meets twice the gap between 

two consecutive sessions may be less than 30 weeks. 

4.5 In his summary, the Chairman of the GESAMP-BWWG concluded that one possible 

approach to solving this problem could be to further increase the membership of the Group to allow 

submissions to be processed more quickly. 

5 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER 

MANAGEMENT SYSTEMS 

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

 .1 Annex 4 Review of the Electro-Clean Ballast Water Treatment System,

submitted by Republic of Korea for Final Approval 

 .2 Annex 5 Review of the Clear Ballast Ballast Water Treatment System, 

submitted by Japan 

 .3 Annex 6 Review of the CleanBallast! Ballast Water Treatment System, 

submitted by Germany 

5.2 Whilst it is recommended that the summary, results and discussion of each of the reviews 

are considered in detail, the Group recommended that: 

 .1 the Electro-Clean Ballast Water Treatment System, submitted by Republic of 

Korea is NOT granted Final Approval; 

 .2 Basic Approval be granted to the Clear Ballast Ballast Water Treatment System, 

submitted by Japan; and 

 .3 the CleanBallast! Ballast Water Treatment System, submitted by Germany is NOT 

granted Final Approval.

6 CONSIDERATION OF QUERIES REGARDING THE WORK OF THE 

GESAMP-BWWG 

6.1 The Secretariat introduced an inquiry received from the Government of China regarding 

the possibility of submitting toxicity testing of the treated ballast water for Basic Approval as 

opposed to laboratory tests; the query is outlined in document GESAMP-BWWG 4/6. 

6.2 The Group noted that in practice some manufacturers may conduct toxicity testing using 

the treated ballast water discharged from the land-based testing facilities, and use the toxicity 

testing data obtained from the land-based testing facilities to apply for Basic Approval. 
GESAMP-BWWG 4/9 - 6 - 

I:\MEPC\57\2.doc 

6.3 Since the treated ballast water discharged from the land-based testing facilities may well 

reflect the situation more accurately than that simulated in the laboratory, the Group was of the 

view that the toxicity testing data obtained from the land-based testing facilities should be 

accepted for Basic Approval provided that the testing items, procedures and results as required in 

Procedure (G9) and the Methodology are fully complied with. 

6.4 However, the Group pointed out that land-based, full-scale testing facilities can be quite 

inflexible (one or two tanks); and as several sets of environmental conditions are to be covered, 

e.g. salinity and organic loading, a bench scale/pilot scale system may often allow questions to be 

answered more effectively during Basic Approval. 

6.5 The submission of ecotoxicity tests using water from a land based facility for 

Basic Approval would not in any way preclude the GESAMP BWWG from requiring 

further/improved testing for Final Approval. 

7 ANY OTHER BUSINESS 

7.1 Development of a Human Exposure Scenario (BWWG 3/9)

7.1.1 The Group noted the endorsement by MEPC 56 of its proposal to develop a 

Human Exposure Scenario document. 

“Having considered the report of the Ballast Water Review Group (MEPC 56/WP.4) and 

the comments made by various delegations, the Committee:

- endorsed the need for a Human Exposure Scenario (HES) as part of the Risk 

Assessment procedure for ballast water management systems, and instructed the Ballast 

Water Working Group and BLG 12 to further consider the HES through formal technical 

negotiations based on the outline provided by GESAMP BWWG. In this respect, the 

Committee invited Members and observers to submit their comments on annex 9 of the 

GESAMP-BWWG report attached to document MEPC 56/2/2 for further consideration on 

this matter at BLG 12.” 

7.1.2 From the submissions received by the GESAMP-BWWG to date, it is clear that 

manufacturers need further advice on how to approach exposure assessment. In this respect, the 

Group identified the need to further define how occupational exposure may occur on board ships 

as a result of BWM systems being operated. 

7.1.3 In annex 9 of the report on the third meeting of the Group (GESAMP-BWWG 3/9), 

a framework was outlined for assessing the risks to human health. This consisted of four steps: 

 .1 Hazard identification – what are the substances of concern and what are their 

effects? 

 .2 Dose (concentration) – response (effect) relation – what is the relationship 

between the dose and either the severity or the frequency of the effect? 

 .3 Exposure assessment – what is the intensity, and the duration or frequency of 

exposure to an agent? 

 .4 Risk characterization – how to quantify the risk from the above data? 
 - 7 - GESAMP-BWWG 4/9 

I:\MEPC\57\2.doc 

The Group considered that in general, step 1 was adequately considered in most submissions. 

However, steps 2 and 3 generally lacked sufficient information, leading to a worse case approach 

to risk assessment. 

7.1.4 The identification of ‘unit operations’ in the whole BWM process of each system is 

important to the understanding human exposures. To achieve this, more information than 

contained in the submissions to date is required from applicants. The term ‘unit operation’ is 

used in chemical process engineering to describe a basic step in a process. A chemical or other 

manufacturing/treatment process may have many unit operations. Occupational hygienists 

depend on knowledge of such unit operations to be able to determine exposure to chemicals 

involved in each step of a process. A similar approach is proposed with regard to BWMS 

evaluations. 

7.1.5 Applicants should be requested to describe the ballast water treatment process associated 

with their system as a set of unit operations, i.e. in doing so, identifying clearly which individual 

system components of a BWMS are likely to lead to human exposure to active substances, 

relevant substances and by-products. Then, for each system component, including connecting 

piping, a description of such exposures needs to be provided, e.g. chemical storage, chemical 

application, processing of treated ballast water, ballast tank operations, including associated 

piping, as well as discharge operations. Applicants should then state the risk reduction 

measures envisaged for all of the above-defined unit operations, i.e. stating clear Personal 

Protective Equipment requirements for each step in the process. 

7.1.6 Maintenance, equipment failure and accident situations should be considered separately 

from conditions of normal operation. 

7.1.7 On this basis it will be possible to gather adequate information on individual systems that 

will facilitate a much improved human health risk assessment. It may be possible to categorize 

similar systems on the basis of such accumulated information. This could then lead towards the 

development of a human exposure scenario model. 

7.1.8 The Group agreed to develop a questionnaire on human exposure and unit operations 

(see draft Guidelines for ballast water sampling (G2)) to help manufacturers provide the right 

data and to better assess human exposure scenarios associated with BWMS on board ships. 

7.2 Methodology for information gathering and conduct of work (the Methodology) 

7.2.1 In the evaluation of BWMS, during GESAMP-BWWG meetings 1 through 4, the Group 

noted that occasionally only two chronic NOECs are available for use in the marine risk 

assessment and that in such cases, further guidance on selecting the appropriate assessment 

factors is needed. 

7.2.2 The Group agreed that if chronic tests included the most sensitive organism from the 

acute set of three tests, then an Assessment Factor (AF) of 100 could be used on a case by case 

basis. If the most sensitive group is not included, then an AF of 1000 should be applied. 
GESAMP-BWWG 4/9 - 8 - 

I:\MEPC\57\2.doc 

7.2.3 The Group agreed to add the description of the Final Approval process based 

on the previous consideration contained in paragraphs 5.4 to 5.6 of its third report 

(GESAMP-BWWG 3/9) to the Methodology. The Final Approval process, as summarized 

below, will be added under section 10 of the Methodology: 

“10.1 In accordance with paragraph 5.2.1 of the Procedure (G9) for Final Approval, the 

discharge testing should be performed as part of the land-based type approval process 

using the treated ballast water discharge. 

10.2 In order to obtain Final Approval in accordance with paragraph 8.2 of 

Procedure (G9) the following criteria have to be met: 

 .1 Basic Approval has to be given first; 

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

the Type Approval tests in accordance with Guidelines for Approval of 

Ballast Water Management Systems (G8). Although Guidelines (G8) are 

concerned with efficacy testing, paragraph 1.6.4 of part 1 of its annex 

provides the link between the Guidelines (G8) and the Procedure (G9) and 

consequently the test results from both Guidelines (G8) and Procedure (G9) 

would be used by MEPC to grant Final Approval. This would then allow 

the Administration to issue a Type Approval Certificate as shown in the 

appendix to Guidelines (G8). In this context Type Approval of any 

equipment used onboard ship should be given when the relevant approval 

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 and the risks to the ship and crew have been 

adequately addressed; 

 .3 apart from any other conditions 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; 

 .4 toxicity testing should be done on two types of seawater at two appropriate 

time intervals, after treatment, and organisms normally found in the 

selected types of seawater should be used in the toxicity testing; 

 .5 all information related to Total Residual Oxidants (TROs), Total Residual 

Chlorine (TRC) and the chemicals included in such groupings, including 

their concentrations, should be provided to the GESAMP-BWWG 

for Final Approval when requested as part of its evaluation for 

Basic Approval; 

 .6 in addition to the basic data set needed for the treated ballast water and the 

individual chemicals produced by the system – as identified in the 

Methodology for Basic Approval – a generated meaningful PEC/PNEC 

ratio would be required for Final Approval; and 
 - 9 - GESAMP-BWWG 4/9 

I:\MEPC\57\2.doc 

.7 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.” 

7.2.4 The Group also agreed to add a section on developing Human Exposure Scenarios using 

the guidance contained in annex 9 of its third report (GESAMP-BWWG 3/9) supplemented by 

the above clarification regarding occupational exposure and the proposed questionnaire. 

8 TENTATIVE DATE FOR THE NEXT MEETING

8.1 The Group agreed that its next meeting will take place from 14 to 18 January 2008 

and should review the remaining four proposals received before the submission deadline 

of 7 September 2007. 

9 CONSIDERATION AND ADOPTION OF THE REPORT

9.1 A draft report of the 4th meeting of the GESAMP-BWWG was produced 

on 9 November 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 18.00 hrs. 

*** 

GESAMP-BWWG 4/9 

I:\MEPC\57\2.doc 

ANNEX 1 

LIST OF MEMBERS WHO ATTENDED THE FOURTH SESSION 

OF THE GESAMP BALLAST WATER WORKING GROUP 

Dr. C.T. Bowmer (Chairman) 

TNO Chemistry 

Utrechtseweg 48 

Post Box 360 

3700 AJ Zeist 

The Netherlands 

E-mail: 

Tel: 

Fax: 

Mobile: 

tim.bowmer@tno.nl

+31 30 694 4645 

+31 30 694 4099 

+31 6 5318-1352 

Ms. Teresa Borges 

Senior Technical Officer 

Praça Pasteur 

No. 9 - 1◦

 esq. 

1000-238 Lisboa 

Portugal 

E-mail: 

Tel: 

Mobile: 

tborges@dgs.pt

+351 2 1843 0599 

+351 9 1779 8048 

Mr. Egil Dragsund 

Principal Marine Biologist 

Environmental and Technical Solutions 

Det Norske Veritas AS 

Veritasveien 1 

NO- 1322 Høvik 

Norway 

E-mail: 

Tel: 

Fax: 

Mobile: 

egil.dragsund@dnv.com

+47 6757 8894 

+47 6757 9911 

+47 9702 6956 

Mr. Shinichi Hanayama 

Senior Research Fellow 

Maritime Technology Department 

Ocean Policy Research Foundation 

1-15 Toranomon 

Minatoku-ku 

Tokyo 105-0001 

Japan 

E-mail: 

Tel: 

Fax: 

s-hanayama@sof.or.jp 

+81 3 3502 1886 

+81 3 3502 2033 

Ms. Annette Kronborg 

Director 

Adalia Toxicology Consultants 

Runslingan 3E 

SE-187 72 TÄBY 

Sweden 

E-mail: 

Tel: 

Fax: 

Mobile: 

annette.kronborg@adalia.se

+46 8 510 149 36 

+46 8 510 126 02 

+46 70 483 11 23 
GESAMP-BWWG 4/9 

ANNEX 1 

Page 2 

I:\MEPC\57\2.doc 

Mr. Jan Linders 

Senior Risk Assessor 

National Institute for Public Health and 

 Environment Expert Centre on Substances 

Anthonie van Leeuwenhoeklaan 9 

RIVM-SEC 

P.O. Box 1 

NL-3720 BA Bilthoven 

The Netherlands 

E-mail: 

Tel: 

Fax: 

jan.linders@rivm.nl 

+31 30 274 3164 

+31 30 274 4401 

Mr. David Tongue 

Marine Manager 

International Chamber of Shipping 

12 Carthusian Street 

London EC1M 6EZ 

United Kingdom 

E-mail: 

Tel: 

Fax: 

Mobile: 

david.tongue@marisec.org

+44 20 7417 2860 

+44 20 7417 8877 

+44 78 5539 1258 

IMO-GESAMP CONSULTANT 

 

Dr. Brigitte Behrends 

Marine Environment Chemist 

Marena Ltd. 

St. Annenstr. 27 

Jever 

D-26441 

Germany 

E-mail: 

Tel: 

Mobile: 

brigitte.behrends@marenaltd.com 

+49 (0) 4461 984 098 

+49 (0) 16 2244 3484 

GESAMP 

 

Mr. Fredrik Haag 

GESAMP Officer 

Marine Environment Division 

International Maritime Organization 

4 Albert Embankment 

London SE1 7SR 

United Kingdom 

E-mail: 

Tel: 

Fax: 

fhaag@imo.org 

+44 (0)20 7463 4139 (Direct) 

+44 (0)20 7587 3210 
GESAMP-BWWG 4/9 

ANNEX 1 

Page 3 

I:\MEPC\57\2.doc 

IMO SECRETARIAT

 

Mr. Dandu Pughiuc 

IMO Technical Secretary to GESAMP-BWWG 

Marine Environment Division 

International Maritime Organization 

4 Albert Embankment 

London SE1 7SR 

United Kingdom 

E-mail: 

Tel: 

Fax: 

dpughiuc@imo.org 

+44 (0)20 7587 3247 (Direct) 

+44 (0)20 7587 3261 

Mr. Huang Tianbing 

Technical Officer, Marine Biosafety Section 

Marine Environment Division 

International Maritime Organization 

4 Albert Embankment 

London SE1 7SR 

United Kingdom 

E-mail: 

Tel: 

Fax: 

thuang@imo.org

+44 (0)20 7463 4198 (Direct) 

+44 (0)20 7587 3261 

*** 

GESAMP-BWWG 4/9 

I:\MEPC\57\2.doc 

ANNEX 2 

AGENDA FOR THE FOURTH SESSION 

OF THE GESAMP BALLAST WATER WORKING GROUP 

1 Introduction 

2 Issues of confidentiality 

3 Outcome of MEPC 56 

4 Terms of reference and time frame 

5 Review of proposals for approval of Ballast Water Management Systems 

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

7 Any other business 

8 Date for the next meeting 

9 Consideration and adoption of the report

*** 

GESAMP-BWWG 4/9 

I:\MEPC\57\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 57. 

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 4/9 

I:\MEPC\57\2.doc 

ANNEX 4

REVIEW OF PROPOSAL FOR THE APPROVAL OF ACTIVE SUBSTANCES 

Electro-Clean System using electrolytic disinfection 

Submitted for Final Approval by the Republic of Korea as MEPC 57/2/1 

0 SUMMARY 

0.1 Final Approval of the Electro-Clean System (ECS) using electrolytic disinfection is not

recommended to be granted based on the submission provided by the Republic of Korea.

0.2 The Group noted that the proposed system is based on electrolytic disinfection of 

seawater and brackish water. The ballast water is disinfected through oxidation, including the 

production of active substances such as hydroxyl radicals and Free Active Chlorine. In addition, 

various by-products defined as Relevant Chemicals are produced from reactions between Active 

substances and naturally occurring compounds in the treated water. The group noted that 

hydrogen and chlorine gases are also generated in the system. The active substances are not 

required to be stored onboard as they are generated on demand. The submission informs that 

a neutralizing stage will be required to ensure that the maximum designed TRC-concentration 

(2 mg/L) is not exceeded. 

0.3 The Group noted that the maximum required Total Residual Chlorine (TRC) 

concentration for effective disinfection was 10 mg/L with measured TRC levels at 

around 1 to 2 mg/L at discharge after 3 to 5 days storage in ballast tanks. Therefore, the Group 

considers the concentration of 10 mg/L as the Maximum Dosage and the concentration of 2 mg/L 

as the Maximum Allowable Discharge Concentration according to the G9-evaluation. It was also 

noted that the required TRC-concentration has been reduced from the levels of 20 – 30 mg/L 

indicated at Basic Approval. 

0.4 The Group noted that a number of land-based and shipboard tests had been carried out for 

the evaluation under G8 and to identify disinfection by-products in accordance with 

the G9-procedures. However, it was unclear if the discharge toxicity tests had been conducted on 

samples drawn from the G8 land-based efficacy tests as required by G9. 

0.5 The Group noted that the two water qualities used in the land-based test set-up were not in 

accordance with the requirements in G8 regarding salinity and the content of organic matter 

(POC and DOC). All tests carried out were in the 15-22 PSU salinity range for brackish water 

and 28.7-33.4 PSU range for seawater which is not in accordance with the G8 procedure. 

Furthermore, the organic matter concentration was too low in the majority of the tests. Low 

levels of organic matter will reduce the levels of chlorination by-products produced and thereby 

also the toxicity of treated ballast water. This substantially increases the uncertainties of 

conclusions drawn from the ecotoxicity tests performed and from the results from the chemical 

analysis of treated ballast water. 

0.6 The Group noted that the dossier identified a limited number of active substances and 

relevant chemicals and that many others have been identified in other dossiers with similar 

systems and in open literature. The Group further noted that the reaction between chlorine gas 

and bromide ions was not discussed in the dossier. Consequently, the information provided was 

inadequate for a number of potentially relevant chemicals. 
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0.7 The Group considered that brominated DBPs (Disinfection By-Products) are the 

toxicologically relevant compounds generated by the process. As the applicant did not provide 

information concerning the potential exposure of humans to volatile substances, e.g. as outlined 

in the Human Exposure Scenario (MEPC 56/2/2, annex 9), the Group noted that the Human Risk 

Assessment could not be adequately completed. The Group, therefore, was only able to adopt a 

precautionary approach and recommended that human exposure when handling ballast water 

treatment operations should be restricted and that Risk Mitigation Measures be put in place.

0.8 The Applicant carried out hydrogen and chlorine gas measurements during a land-based 

full-scale system testing and during shipboard testing. The lower explosion limit (LEL) for 

hydrogen gas is 4% under standard conditions. The highest values of gas concentration measured 

during the tests were 1.3% hydrogen and 0.9 ppm (v/v) chlorine gas, respectively. The Applicant 

states that due to the low concentrations no further ventilation system would be required. 

However, adequate measurement and control mechanisms for hydrogen and chlorine should be 

pit in place to ensure that dangerous levels do not occur. 

0.9 The Applicant carried out corrosion tests using coated test samples exposed to treated and 

untreated ballast water. No accelerated corrosion to the test panels was found to be due to the 

treated ballast water. However, no uncoated test samples were used and the test is therefore 

mainly a test of the coating systems and with limited valid information about the corrosivity of 

the treated ballast water. 

0.10 The submission indicates that the provision of mitigation procedure using a neutralizing 

agent, sodium bisulphite, is required to ensure that the maximum allowable discharge 

concentration of TRC (2 mg/L) is not exceeded. The Group noted that this component has not 

yet been tested in an operational system; therefore, the Group considers that confidence in the 

maintenance of the maximum allowable discharge concentration of TRC at any given time 

cannot be ensured at present. In this context, the environmental risks occurring through the use 

of this system are not acceptable according to G9. 

0.11 The Group noted that an ECS system has been installed on a second vessel for additional 

shipboard testing. The Applicant states that these matters are “still under the test for biological 

efficacy, influence to the environment and risk assessment on crew and ships.” 

0.12 Risks to the safety of the ship from the production of hydrogen by the BWMS was 

reported on by the applicant. The group were satisfied that under the operating conditions 

described in the application, the concentrations of hydrogen produced during land based and 

shipboard testing remained at safe levels, i.e. less than one quarter of the LEL of 4%. 

Care should be take that in fully operational systems that hydrogen levels are not allowed to 

exceed such safe levels, otherwise ventilation would be required. 

0.13 Chlorine gas was also measured in the land based (barge) and ship board tests and 

at 0.9ppm was considered by the group to be close to the published acute human exposure 

limits. The group therefore considered that additional risk mitigation measures will be 

necessary immediately following treatment. 

0.14 The Group recommends that corrosivity continues to be monitored as part of the normal 

operation of the ECS system. 
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1 INTRODUCTION 

1.1 The data for this product were extracted from the submission of the Republic of Korea to 

MEPC (MEPC 57/2/1) and the application dossier. 

2 COMPLETENESS OF DOSSIER 

2.1 It was noted that the applicant had submitted the following material for consideration by 

the GESAMP BWWG: 

 .1 A non-confidential Application Dossier, which contains a summary of the data 

and results (MEPC 57/2/1). 

 .2 An Application Dossier for Final Approval, which contains information about the 

disinfection mechanism of ECS, a working Procedure, removal Efficiency of 

microorganisms, data sets of Active Substances and disinfection by-products, 

toxicity tests with ECS treated water, a risk assessment and the assessment report. 

 .3 Furthermore, the Applicant submitted appendices with acute and chronic toxicity 

test protocols, emission scenario protocols, MSDS sheets, information about the 

ECS installation and operation, chemicals data sheets and the shipboard 

test report. 

2.2 The Group identified that the following information was not provided in the dossier: 

 .1 The applicant did not provide sufficient information concerning human exposure 

to active substances, relevant chemicals and by-products, e.g. a described in 

MEPC 56/2/2, annex 9. 

 .2 Full laboratory reports from the ecotoxicity testing and chemical analysis of 

treated ballast water were not provided. They are referred to in the dossier, but 

there is no description of how samples were handled before analysis. Furthermore, 

there is no information about which land based tests (G8) have been used 

sampling for the purpose of ecotoxicity testing and chemical analysis of 

disinfection by-products. 

 .3 The dossier does not provide any information about how the neutralizing agent 

bisulfite is stored on board and how it is added to the discharged ballast water. 

 .4 Several of the Active substances and relevant chemicals known from the literature 

and from other BWMS applying electrolysis of seawater are not identified by the 

dossier and therefore it does not include sufficient information. Examples are 

hypobromous acid and hydroxyl radicals. 
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2.3 The GESAMP-BWWG requested: 

.1 Clarification on the way in which the concentration of hydrogen (H2) and chlorine 

(Cl2) were measured and calculated. 

.2 Identification of the sample number (Table 6-14 and 6-15 on page 111 of the 

Application Dossier), which have been analysed for disinfection by-products 

(page 110). 

.3 Information on the Sodium bisulfite: 

- MSDS sheets 

- Storage, usage and handling 

- How and when is Sodium bisulfite applied? 

.4 Which samples were used for ecotoxicity testing? 

.5 In the submission for Basic Approval a pre-filtration unit has been mentioned. 

Since the GESAMP-BWWG could not find any information regarding the use of 

this unit in the submission for Final Approval, please confirm if this unit is still 

used and if so, provide detailed information on it. 

.6 Regarding H2 Concentration after treatment. The data indicate that the maximum 

concentration of H2 gas in the ballast tank following treatment with SCR is 0.9%. 

a) How full was the ballast tank when these readings were taken? 

b) Was the concentration of H2 being expelled from the vent pipe monitored 

during ballast tank filling? 

.7 The various bench tests show H2 concentrations in excess of 3% being found 

regularly and very high levels also experienced. The submission states that 

conditions require to be controlled to ensure H2 concentrations do not reach 

dangerous levels. As H2 lower explosive limit (LEL) is 4%, excess of 3% is 

considered of concern. How is the concentration level “controlled”, and what is 

the real chance of H2 level in tank and leaving tank vent reaching 4% vv? 

2.4. The Applicant answered: 

.1 Question 2 was not answered sufficiently in the first instance. The Groups 

intention for this question was that “Total Organic Carbons will affect the 

production rate of DBPs, such as bromoform and HAA”. For this reason, the 

Group requested the chemical parameters (TOC, POC, etc) of seawater used in 

DBPs analysis in page 110. After personal communication this question was 

answered sufficiently. 

.2 Regarding Question 3, the Group discovered after personal communication that 

the mitigation procedure for the neutralization agent sodium bisulfite was still 

under development. 
GESAMP-BWWG 4/9 

ANNEX 4 

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I:\MEPC\57\2.doc 

.3 Answers to the other questions were delivered by the Applicant to the Group’s 

satisfaction. 

3 DESCRIPTION OF BWMS AND DATA-SET REQUIRED IN THE APPLICATION 

3.1 Description of the ballast water management system 

3.1.1 The applicant informs that the Electro-Clean System (ECS) ballast water management 

system has been engineered for the disinfection of micro-organisms without the storage and 

addition of any synthetic chemicals onboard. Disinfection is achieved by direct oxidation of 

organisms at the electrodes in the cell and due to the Active substances (measured as 

Total Residual Chlorine, TRC) produced. With the application of electric currents, hypochlorite 

(active substance) is generated in-situ and disinfects the micro-organisms. In addition to this, 

electric potential and OH radicals generated during the electrolysis procedure also disinfect 

micro-organisms. Hypochlorite is highly reactive and degrades in seawater containing both 

organics and inorganics. 

 

3.1.2 The submission for final approval indicates that the system is intended to treat the ballast 

water on uptake only. The Group noted that in the application for basic approval the treatment 

system proposed also included a filtration phase, which was no longer apparent. Further 

communication with the applicant confirmed that the filtration phase was considered no longer 

required. 

3.1.3 The Group noted that in the non-confidential information provided it was stated that no 

substances are added to the system. However, the confidential Application Dossier informs that 

a neutralizing agent (sodium bisulfite) may be added at discharge. This information advises that 

sodium bisulfite is to be added when monitored TRC levels exceed 2 mg/L in the discharged 

ballast water and that at lower levels no bisulfite is required, unless local regulations demand a 

lower TRC discharge level. However, the precise description of this component was not 

included in the application. The group cannot evaluate how the TRC concentration should be 

monitored by reliable sensors in each ballast tank and how the mixing rate can be controlled 

under high volume discharging (such as >1,000 m3

/h). After further communication with the 

applicant, the Group concluded that this component of the system has not yet been developed or 

tested in an operational system. Also, the applicant claimed that this mitigation system is used 

only for rare extreme conditions. The Group cannot accept this design concept. The Group has 

the opinion that for the short voyage less than 2 days etc., the reliability of this component should 

be the most important key part among the whole ballast water treatment system to ensure the 

maximum allowance discharge concentration, which is required in G9. 

3.1.4 The Group also noted that the system incorporated a salinity sensor to control the power to 

the electrolytical cell and a monitoring of the TRC concentration to maintain the required level of 

TRC (spectrophotometric measurement with DPD reagent) and a salinity sensor to maintain the 

required level of TRC, which is dependant on salinity, but also to avoid discharge of excess TRC. 

3.2 Active Substances, Relevant Chemicals and Other Chemicals 

3.2.1 The Group noted that the Active Substance identified by the dossier used in this BWMS 

is generated onboard when the chloride ions in seawater is oxidized to chlorine gas which 

subsequently reacts with seawater to produce hypochlorite (OCl-

) and hypochlorous acid (HOCl). 

The Active substances are measured as Total Residual Chlorine (TRC). The Group also 

considers that bromates and hypobromite and hypobromous acid are relevant substances. 
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3.2.2 To maintain the disinfection of the ballast water at varying salinities and suspended 

matter a TRC concentration of 10 mg/L has been identified by the applicant to be sufficient, 

even though 20-30 mg/L TRC was applied during the Basic Approval testing. Therefore the 

initial TRC level has been reduced from 30 mg/L to 10 mg/L. 

3.2.4 The submission states that hydroxyl radicals have a very short lifetime during 

ECS operation, and also as the ballast water flows quickly through the ECS, there was no 

notable effect on disinfection in the ballast water. 

3.2.5 TRC or hypochlorite has been identified as Active Substance. The data on hypochlorite 

from the dossier are summarized in table 1. 

Table 1: The identification of hypochlorite (MEPC 57/2/1, table 5-1) 

Item Information 

IUPAC name hypochlorite 

CAS number 14380-61-1 

UN number 3212 

Molar mass 51.452g/mol 

Empirical formula OClStructural formula 

Purity of technical material and 

identification of impurities 

Bleach, hypochlorous acid, sodium salt; soda bleach; 

sodium oxychloride 

5% of sodium hypochlorite and 95% of water 

Stabilizers or necessary 

additives 

For pools using liquid chlorine (sodium hypochlorite) or 

calcium hypochlorite, add stabilizer (cyanuric acid). 

3.2.6 The Group noted that several other active substances such as hydrogen gas have been 

identified in other dossiers with similar systems and in open literature. The Group further noted 

that the reaction between chlorine gas and bromide ions was not discussed in the dossier. 

Chlorine reacts with the bromide ions to form hypobromous acid which should also be 

presented as an Active substance in the dossier. Similar to the equilibrium 

hypochlorite/hypochlorous acid hypobromous acid will exist in equilibrium with hypobromite. 

3.2.7 Hypochlorite, hypochlorous acid, hypobromite and hypobromous acid are all highly 

reactive and degrade in seawater containing both organics and inorganics and consequently 

produce a number of disinfection by-products (DBP). 

3.2.8 TRC includes free residual chlorine of undissociated and dissociated hypochlorite 

together with undissociated and dissociated hypobromite when chlorine is dissolved in water, 

plus combined residual chlorine halogens of chloramines halogeneamines formed by reacting 

with ammonia. 

3.2.9 The two largest identified fractions of chlorination by-products are trihalomethanes 

(THM) and haloacetic acids (HAA). 

3.2.10 Table 2 and Table 3 show the analytical results of disinfection by-products from 

electrolysis of brackish (Sum-Jin River, 18 – 20 PSU) and seawater (Ma-San Port, 28 – 30 PSU) 

by ECS operation at 10 mg/L of TRC. The Group considered that the number of samples 
GESAMP-BWWG 4/9 

ANNEX 4 

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analysed fell far short of a representative amount, to give sufficient confidence in the reliability 

of the results. 

Table 2: List of disinfection by-products (THM, HAA and bromate) in the brackish water 

(18 – 20 PSU) from Sum-Jin River after ECS treatment (MEPC 57/2/1, table 5-2) 

List of all potential by-products produced in ballast water

Chemical name CAS number 

Control 

water 

(mg/L) 

Treated 

water 

(mg/L) 

Detection 

limit (mg/L) 

THM 

Trichloromethane 000067-66-3 N.D. N.D. < 0.0001 

Bromodichloromethane 000075-27-4 N.D. N.D. < 0.0001 

Dibromochloromethane 000124-48-1 N.D. 0.0083 < 0.0001 

Tribromomethane 000075-25-2 N.D. 0.1081 < 0.0001 

THM 0.1164 

 

HAA 

Monochloroacetic acid 000079-11-8 N.D. N.D. < 0.0001 

Dichloroacetic acid 000079-43-6 N.D. N.D. < 0.0001 

Trichloroacetic acid 000076-03-9 N.D. N.D. < 0.0001 

Monobromoacetic acid 000079-08-3 N.D. N.D. < 0.0001 

Dibromoacetic acid 000631-64-1 N.D. 0.0136 < 0.0005 

Tribromoacetic acid 000075-96-7 N.D. 0.0042 < 0.0005 

Bromochloroacetic acid 005589-96-8 N.D. N.D. < 0.0001 

Bromodichloroacetic acid 71333-14-7 N.D. N.D. < 0.0005 

Dibromochloroacetic acid 005278-95-5 N.D. N.D. < 0.0005 

THAA 0.0178 

 

Bromate ion 015541-45-4 N.D. N.D. < 0.002 
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Table 3: List of disinfection by-products in the seawater of Ma-San Port (28 – 30 PSU) 

after ECS treatment (MEPC 57/2/1, table 5-3) 

List of ALL potential by-products produced in ballast water

Chemical name CAS number 

Control 

water 

(mg/L) 

Treated 

water 

(mg/L) 

Detection 

limit (mg/L) 

THM 

Trichloromethane 000067-66-3 N.D. N.D. < 0.0001 

Bromodichloromethane 000075-27-4 N.D. N.D. < 0.0001 

Dibromochloromethane 000124-48-1 N.D. 0.0093 < 0.0001 

Tribromomethane 000075-25-2 N.D. 0.1231 < 0.0001 

HAA 

Monochloroacetic acid 000079-11-8 N.D. N.D. < 0.0001 

Dichloroacetic acid 000079-43-6 N.D. N.D. < 0.0001 

Trichloroacetic acid 000076-03-9 N.D. N.D. < 0.0001 

Monobromoacetic acid 000079-08-3 N.D. N.D. < 0.0001 

Dibromoacetic acid 000631-64-1 N.D. 0.0162 < 0.0005 

Tribromoacetic acid 000075-96-7 N.D. 0.0051 < 0.0005 

Bromochloroacetic acid 005589-96-8 N.D. N.D. < 0.0001 

Bromodichloroacetic acid 71333-14-7 N.D. N.D. < 0.0005 

Dibromochloroacetic acid 005278-95-5 N.D. N.D. < 0.0005 

Bromate ion 015541-45-4 N.D. N.D. < 0.002 

3.2.11 As a result of this analysis, four major by-products have been identified by the applicant 

at the two test sites. The four identified by-products of ECS ballast water treatment were 

dibromochloromethane, tribromomethane, dibromoacetic acid and tribromoacetic acid. 

The information of these by-products is shown in tables 4-7. 

3.2.12 The Group noted that analysis of the land-based tests was carried out under conditions 

outside the range for salinities and organic carbon as established in G8. Low levels of organic 

carbon in the samples analyzed may have resulted in low levels of chlorination by-products and 

thereby the toxicity assessment of the treated ballast water. 

3.2.13 As indicated in the report of its 3rd meeting, the Group needs to evaluate the range of 

potential by-products at 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. In general the analysis 

should at the minimum include all by-products known from similar applications of oxidants in 

seawater such as AOX, EOX, Total THM, trichloromethane, chloroform, tribromomethane, 

bromoform, dibromochloromethane, dichlorobromomethane, monobromoacetic acid, 

dibromoacetic acid, tribromoacetic acid, bromochloroacetic acid, dibromochloroacetic 

acid, bromodichloroacetic acid, monobromoacetonitrile, dibromoacetonitrile, 

bromochloroacetonitrile, 2,4-dibromophenol, 2,6-dibromophenol, 2,4,6-tribromophenol, 

dibromoethane, 1,2,3-trichloropropane, 2-chlorotoluene, 4-chlorotoluene, 1,2-dibromo-3-

chloropropane and 1,2,3-tribromobenzene. 
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Table 4: The information of dibromochloromethane (MEPC 57/2/1, table 5-4) 

Item Information 

IUPAC name dibromochloromethane 

CAS number 124-48-1 

UN number N.A. 

Molar mass 208.28 

Empirical formula ClCHBr2 

Structural formula 

Purity of technical material and identification of impurities 99% of 

dibromochloromethane 

Stabilizers or necessary additives N.A. 

Table 5: The information of tribromomethane (MEPC 57/2/1, table 5-5) 

Item Information 

IUPAC name bromoform 

CAS number 75-25-2 

UN number 2515 

Molar mass 252.73g/mol 

Empirical formula CHB3 

Structural formula 

Purity of technical material and identification of impurities 100% of bromoform 

Stabilizers or necessary additives Bromoform is relatively 

stable in the air

Table 6: The information of dibromoacetic acid (MEPC 57/2/1, table 5-6) 

Item Information 

IUPAC name dibromoethanoic acid 

CAS number 631-64-1 

UN number N.A. 

Molar mass 217.84 

Empirical formula C2H2Br2O2 

Structural formula 

Purity of technical material and 

identification of impurities 

99% of dibromoacetic acid 

Stabilizers or necessary additives Stable at room temperature in closed 

containers under normal storage and handling 

conditions without stabilizer. 
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Table 7: The information of tribromoacetic acid (MEPC 57/2/1, Table 5-7) 

Item Information 

IUPAC name tribromoacetic acid 

CAS number 75-96-7 

UN number N.A. 

Molar mass 296.74g/mol 

Empirical formula C2HBr3O2 

Structural formula 

Purity of technical material and 

identification of impurities 

99% of tribromoacetic acid 

Stabilizers or necessary additives Stable at room temperature in closed 

containers under normal storage and handling 

conditions without stabilizer. 

4 HUMAN HEALTH ASSESSMENT

For the presented data see Appendix I, part 3, Mammalian toxicity. 

4.1 According to the data presented, hypochlorite is considered to be harmful by inhalation 

and dibromochloromethane, tribromomethane by oral exposure. On the other hand, 

tribromomethane is classified as toxic by inhalation (GHS classification, Annex VI, 

COM (2007) 355 final). Additionally, dibromoacetic acid, is not considered to be an acutely 

toxic by oral route and for tribromoacetic acid, no data was submitted to assess acute toxicity. 

4.2 Hypochlorite is classified as a skin and eye irritant and a sensitizer. Additionally, 

tribromo-acetic acid is considered to be corrosive to skin and eye. tribromomethane is classified 

as a skin and eye irritant, causing serious eye irritation (GHS classification, Annex VI, 

COM (2007) 355 final). 

4.3 According to the data presented, there seemed to be no relevant toxicological concerns 

towards repeated exposure to hypochlorite, dibromo- and tribromochloromethane, dibromo and 

tribromoacetic acid. 

4.4 From the submitted data, some reproduction toxicological effects were noted in 

association with exposure to dibromoacetic acid and tribromomethane to rodents at high doses. 

4.5 Relevant adverse effects related to target organs (liver and testis) were observed in the 

data presented. Chlorinated and Brominated DPB, have a potential human 

genotoxicity/carcinogenicity and will therefore need to be kept below toxicologically critical 

levels (bromate <10μg/L; bromoform <100μg/L; chloroform <200 μg/L, WHO Guidelines for 

Drinking Water Quality, 2003). 
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5 RISK TO SAFETY OF SHIP AND CREW 

5.1 Explosion tests 

When ECS is operated, hydrogen gas is produced and emitted as a result of the electrolysis 

process. Hydrogen gas can cause explosions at high concentrations (4 to 75% v/v air). 

Therefore consideration of the risk of explosion by measuring the concentration of hydrogen 

gases onboard the barge and the M/V STX YOKOHAMA has taken place. 

5.1.1 Hydrogen gas tests 

5.1.1.1 Test with land-based installation 

Hydrogen gas was measured at four different places on the barge and at five different time 

intervals after the ECS operation. The four places were chosen to be: inside the ballast tank, 

around the ECS, on the deck, and in the crew living quarters. Table 8 shows that only low 

concentrations of hydrogen gas were generated. There was no risk of explosion. The safety of 

the ballast tank has been confirmed without the need of any additional ventilation system. 

Table 8: Hydrogen gas concentration on the barge for land-based test 

(MEPC 57/2/1, 5.1.1.1) 

Surveyed location Unit After 

ECS 

Elapse of

1 h 

Elapse of 

2 h 

Elapse of 

12 h 

Elapse of 

24 h 

Ballast tank area % 0.9 0.5 0.2 N.D. N.D. 

Surrounding the ECS % N.D. N.D. N.D. N.D. N.D. 

Alongside vessel % N.D. N.D. N.D. N.D. N.D. 

Upper regions of vessel % N.D. N.D. N.D. N.D. N.D. 

5.1.1.2 Shipboard test 

The values of hydrogen gas were measured in four different places on board of the ship, and at 

five different time intervals after the ECS operation. The four places were chosen to be inside 

of the ballast tank, around the ECS, on the deck, and in the crew living quarters. Table 9 shows 

that only low concentrations of hydrogen gas were generated. There was no risk of explosion. 
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Table 9: Hydrogen gas concentration on the M/V STX YOKOHAMA for on board test 

(MEPC 57/2/1, 5.1.1.1) 

Surveyed location Unit After

ECS 

Elapse of

1 h 

Elapse of 

2 h 

Elapse of 

12 h 

Elapse of 

24 h 

Ballast tank area % 0.8 0.5 0.2 N.D. N.D. 

Surrounding the ECS % N.D. N.D. N.D. N.D. N.D. 

Deck % N.D. N.D. N.D. N.D. N.D. 

Crew’s quarters % N.D. N.D. N.D. N.D. N.D. 

The Group was concerned that the H2 levels indicated by the various tests performed could 

reach the LEL level for H2. However, subsequent communication in which the applicant 

confirmed that the maximum concentrations of H2 measured at any point during the testing 

was 1.3% alleviated this concern. 

5.2.1 Chlorine gas tests 

5.2.1.1 Land-based installation 

Chlorine gas concentrations were measured in four different places and at five different time 

intervals after the ECS operation was finished. The four places were chosen to be inside of the 

ballast tank, around the ECS, on the port and starboard sides of barge and on the deck of the 

barge. The results show up to 0.9 ppm of chlorine gas in the ballast tank. 

Table 10: Variations of chlorine gas land-based installation after land-based test 

(Ref. MEPC 57/2/1, 5.2.1.1) 

Surveyed location Unit After 

ECS 

Elapse of 

1 hr 

Elapse of 

2 hrs 

Elapse of 

12 hrs 

Elapse of

24 hrs 

Ballast tank area ppm 0.9 0.6 0.3 0.1 N.D. 

Surrounding the ECS ppm N.D. N.D. N.D. N.D. N.D. 

Alongside vessel ppm N.D. N.D. N.D. N.D. N.D. 

Upper regions of vessel ppm N.D. N.D. N.D. N.D. N.D. 

5.2.1.2 Shipboard test

The shipboard tests were carried out on the M/V STX YOKOHAMA. Chlorine gas 

concentrations were measured in four different places and at five different time intervals after 

the ECS operation was finished. Maximum chlorine gas concentration was found inside of the 

ballast tank with 0.7 ppm directly after ECS treatment. 
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Table 11: Chlorine gas concentration on the M/V STX YOKOHAMA after 

shipboard test (Ref. MEPC 57/2/1, 5.2.1.2) 

Surveyed location Unit After 

ECS 

Elapse of 

1 hrs 

Elapse of 

2 hrs 

Elapse of 

12 hrs 

Elapse of

24 hrs 

Ballast tank area ppm 0.7 0.5 0.3 0.1 N.D. 

Surrounding the ECS ppm N.D. N.D. N.D. N.D. N.D. 

Alongside vessel ppm N.D. N.D. N.D. N.D. N.D. 

Upper regions of vessel ppm N.D. N.D. N.D. N.D. N.D. 

It is noted by the Group that chlorine levels immediately following treatment in the ballast tank 

area have been measured at 0.9 ppm (V/V) during some tests. This is very close to the short 

term exposure limit for chlorine gas which is 1 ppm, according to the submission. It is 

recognized that the concentration of chlorine gas in the ballast tank decays comparatively 

quickly. However, additional risk mitigation measures will be necessary immediately 

following treatment. 

5.3 Corrosion effect tests (Ref. MEPC 57/2/1, 5.1.2) 

5.3.1 Test conditions 

The corrosion tests were performed using coated test panels. Corrosion tests for the control and 

treated water by ECS were conducted over 6 months using both natural seawater and using 

artificial seawater of 25 PSU. 

5.3.2 Corrosion test results 

It was confirmed that the corrosion rate of the test panels in ECS treated seawater did not show 

significant higher corrosion rates compared to the control test panels. In this regard the Group 

accepted that the original concern related to corrosion raised during basic approval was 

alleviated. However, as only coated test panels were tested, the Group recommends that 

corrosivity continues to be monitored as part of normal operation of the system.

5.4 Risks to human health 

5.4.1 The Group considered that potential human exposure to the active substances generated 

by ECS might result in acute health effects (irritation to skin and respiratory tract). Therefore it 

is recommended as mandatory to ensure the application of RMM (risk management measures) 

for the protection of the exposed populations to the main routes of concern: dermal 

and inhalation. 

5.4.2 As acknowledged, chlorinated and brominated DPB, have a potential for bioaccumulation 

and human genotoxicity/carcinogenicity, therefore these compounds 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). 
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5.4.3 The Group considered that Chlorinated and Brominated DBPs (Disinfection By-Products) 

are the toxicologically relevant compounds generated by the process. As the applicant could not 

provide information concerning the Human Exposure Scenario (MEPC 56/2/2, annex 9), the 

Group noted that an adequate conclusion as to the outcome of the Human Risk Assessment could 

not be achieved. In this sense, the Group adopted a precautionary approach and recommended 

that human exposure when handling ballast water treatment operations should be restricted and 

Risk Mitigation Measures (RMM) put in place.

6 RISKS TO THE AQUATIC ENVIRONMENT 

6.1 ASSESSMENT OF PERSISTENCE (P), BIOACCUMULATION (B) AND 

TOXICITY (T) 

The Group already carried out the PBT assessment at Basic Approval. It was concluded that 

none of the substances applied should be classified as PBT. 

7 ASSESSMENT OF TREATED BALLAST WATER 

7.1 Toxicity tests 

7.1.1 Test conditions 

7.1.1.1 All toxicity tests were carried out with the whole effluent of the land-based 

ECS installations with brackish water from the Sum-Jin River (15 – 22.3 PSU) and seawater 

from Ma-San Port (28.7 – 33.4 PSU). The organic content (TOC, DOC, POC) was significantly 

lower than required by G8 in the majority of tests. This substantially increases the uncertainties 

of conclusions drawn from the ecotoxicity tests performed and from results from the chemical 

analysis of treated ballast water. The tests were performed 3 and 5 days after the treatment 

with 0, 25, 50, 75 and 100% dilutions with culture media or raw water. Table 12 summarizes all 

toxicity tests, which were carried out. The Group noted that initial TRC levels were set 

above 2 mg/L, which is the maximum allowable discharge concentration, even when they use the 

ECS treated water with 5 days tank holding time. Thus the Group considered that this test has 

not performed under adequate Quality Control for the Whole Effluent Toxicity testing, so that the 

resultant PNEC value calculated from these data could have large uncertainties. 

7.1.1.2 The acute and chronic toxicity tests reported by the applicant were carried out as static 

non-replacement tests. As a result the Group considers that the exposures in the chronic test 

were far lower than initial TRC values shown in table 12. 
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Table 12: Overview of all toxicity tests carried out with the ECS treated water 

 Tank 

holding 

times 

[d] 

Organisms % of discharged 

water 

Initial 

TRC 

[mg/L] 

Invertebrate 100 7.3 3 Fish 100 3.3 

Invertebrate 100 1.0 

Brackish

Water 

5 Fish 100 2.7 

Invertebrate 100 7.1 3 Fish 100 2.9 

Invertebrate 100 1.2 

Acute 

toxicity Seawater

5 Fish 100 3.3 

Algae 100 2.5 

3 Invertebrate 40 0.9 

Fish 40 1.1 

Algae 100 1.1 

Invertebrate 40 0.5 

Brackish

Water 

5 

Fish 40 1.0 

Algae 100 2.4 

3 Invertebrate 40 1.0 

Fish 40 1.5 

Algae 100 0.7 

Invertebrate 40 0.6 

Chronic 

toxicity Seawater

5 

Fish 40 0.9 

Table 13: Summary of acute toxicity tests carried out with the ECS treated water 

(Ref. MEPC 57/2/1, 6.2.1.1, 6.2.2.1, 6.2.3.1 and 6.2.4.1) 

FCA Species Salinity

[PSU] days LC50 (mg/L) Comments, etc.

C Artemia nauplii 18 3 1.0 (96hr) 50% artificial brackish water + 

50% ECS treated water 

F Poecilia 

latipinna 18 3 1.7 (96hr) 25% artificial brackish water + 

75% ECS treated water 

C Monocorophium 

acherusicum 30 3 1.4 (96hr) 25% artificial seawater + 

75% ESC treated water 

F Paralichthys 

olivaceus 30 3 0.9 (96hr) 50% artificial seawater + 

50% ECS treated water 

C Artemia nauplii 18 5 1.0 (96hr) 50% artificial brackish water + 

50% ECS treated water 

F Poecilia 

latipinna 18 5 1.1 (96hr) 25% artificial brackish water + 

75% ECS treated water 

C Monocorophium 

acherusicum 30 5 1.2 (96hr) 100% ECS treated water 

F Paralichthys 

olivaceus 30 5 1.1 (96hr) 25% artificial seawater + 

75% ECS treated water 
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Table 14: Summary of chronic toxicity tests carried out with the ECS treated water 

(Ref. MEPC 57/2/1, 6.2.1.2, 6.2.2.2, 6.2.3.2 and 6.2.4.2) 

FCA Species S 

[PSU] days NOEC (mg/L) Comments, etc.

A Skeletonema 

costatum 18 3 0.8 (96hr) 50% F/2 medium (15ppt) + 

50% ECS treated water 

C Artemia nauplii 18 3 0.9 (21d) 60% artificial brackish water + 

40% ECS treated water 

F Poecilia 

latipinna 18 3 1.1 (62d) 60% artificial brackish water + 

40% ECS treated water 

A Skeletonema 

costatum 30 3 0.6 (96hr) 75% F/2 medium (30ppt) + 

25% ECS treated water 

C Monocorophium 

acherusicum 30 3 1.0 (21d) 60% artificial seawater + 

40% ECS treated water 

F Paralichthys 

olivaceus 30 3 1.0 (62d) 70% artificial seawater + 

30% ECS treated water 

A Skeletonema 

costatum 18 5 0.5 (96hr) 50% F/2 medium (15ppt) + 

50% ECS treated water 

C Artemia nauplii 18 5 0.5 (21d) 60% artificial brackish water + 

40% ECS treated water 

F Poecilia 

latipinna 18 5 1.0 (21d) 60% artificial brackish water + 

40% ECS treated water 

A Skeletonema 

costatum 30 5 0.3 (96hr) 75% F/2 medium (30ppt) + 

25% ECS treated water 

C Monocorophium 

acherusicum 30 5 0.6 (21d) 60% artificial seawater + 

40% ECS treated water 

F Paralichthys 

olivaceus 30 5 0.9 (62d) 60% artificial seawater + 

40% ECS treated water 

7.1.1.4 For some organisms, artificial sea water is not considered to be a well chosen medium 

for the tests (Artemia nauplii and Skeletonema costatum). 

7.1.1.5 A large variation of TRC concentrations has been observed. 

7.1.1.6 From the acute toxicity tests carried out with treated BW it is concluded by the Group 

that the lowest 96 h LC50 value for 100% treated ECS water can be set at 1.2 mg TRC/L. 

7.1.1.7 The lowest chronic aquatic toxicity tests revealed an NOEC of 0.6 mg TRC/L for 60% 

artificial seawater plus 40% ECS treated water. No tests were carried out with 100% ECS 

treated ballast water. 

7.1.1.8 The Group considers that only testing for ecotoxicity with treated ballast water 

after 3 and 5 days of storage is insufficient to cover all of the possible storage and discharge 

conditions. Should treated ballast water need to be discharged on a shorter time scale, then 

higher TRC values can be expected. 
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7.2 Degradation of TRC 

TRC degradation rates were measured daily over the course of a week in the two land-based 

installations and in the shipboard ballast tank. The initial TRC concentration measured just after 

treatment in the ballast tank was ca.10 mg/L. 

The half-life of TRC in the ballast tank is about 1 d for dark conditions (Table 15). The Group 

noted that this data clearly indicated that the TRC concentration at discharge with 

less than 2 days tank hold time would probably exceed 2 mg/L, which is set as the maximum 

allowable discharge concentration by the applicant. Thus, the mitigation procedure using a 

neutralizing agent should be installed to all the treatment system using this ECS. 

Table 15: Degradation of TRC in ballast tanks 

TRC (mg/L) After ECS 

treated (day) Test barge 

(Sum-Jin River)

Test barge 

(Ma-San Port) 

M/V STX YOKOHAMA 

(Bu-San Port) 

0 9.7 9.9 7.9 

1 4.5 4.8 3.7 

2 2.5 2.9 2.3 

3 1.9 1.9 1.4 

4 1.5 1.6 1.3 

5 1.3 1.5 1.3 

6 1.3 1.5 1.1 

7 1.2 1.4 0.9 

7.3 Prediction of discharge and environmental concentrations 

7.3.1 Emission scenario of active substance

An analysis of TRC emissions was developed by the applicant for the ECS operation in Bu-San 

port and In-Cheon Port with the following varying input parameters: 

- Tide: spring, neap 

- Volume of discharged water: 33, 50 and 100% 

- TRC half-life: 0.5, 1 and 2 days 

- initial TRC concentrations: 2 and 10 mg/L 

- 250 days with single point discharge 
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Table 16: Summary of Emission Scenarios in Port of Bu-San at spring and neap tide 

(MEPC 57/2/1, 7.3.2 and Application dossier Table 8-38, page 262) 

Diffusion area [km2

] 

Tide Initial 

TRC 

Concentration 

[mg/L] 

TRC half-life Discharged 

water 

[%] 

≥0.05 

[mg/L] 

≥0.1 

[mg/L] 

≥0.2 

[mg/L] 

≥0.3 

[mg/L] 

spring 10 1 100 1.930 0.990 0.445 0.253 

spring 10 1 50 0.990 0.445 0.170 0.098 

spring 10 0.5 100 1.105 0.540 0.235 0.160 

spring 10 0.5 50 0.540 0.235 0.113 0.044 

spring 2 0.5 100 0.185 0.061 0.026 0.007 

spring 2 0.5 50 0.059 0.026 0.005 0.002 

neap 10 1 100 1.546 0.781 0.415 0.264 

neap 10 1 50 0.781 0.415 0.196 0.134 

neap 10 0.5 100 0.789 0.443 0.227 0.135 

neap 10 0.5 50 0.443 0.227 0.117 0.079 

neap 2 0.5 100 0.193 0.089 0.038 0.026 

neap 2 0.5 50 0.089 0.037 0.009 0.005 

For the Port of In-Cheon the areas of the different concentration limits were generally lower. 

Worst-case scenario for the discharge 10 mg/L TRC with a half-life of 2 days and no dilution, 

where the area for concentrations ≥0.05 mg/L limit was 1.930 km2

. 

The Group considered that this was an adequate reflection of the possible short-term 

TRC concentrations. 

7.3.2 PEC calculation

The submission informs that the PEC calculation was obtained according to the Bu-San Port 

statistics referred to in the Emission scenario. From the Korea Ocean Science & Engineering 

Corporation (KOSEC) data the Bu-San Port water volume is 207,000,000 m3 and the annual 

ballast water discharge is 111,683,505 m3. The daily ballast discharge is 305,982 m3. The ECS 

operates at maximum 10 mg/L initial TRC concentration and the maximum discharge level is 

set to be at 2 mg/L. From the assumption that it takes 24 hours for the TRC concentration to 

completely mix with the seawater the ballast water is consequently calculated in standard to the 

one day PEC discharge amount. Therefore, 

mg L mg L PEC 0.00296 /

207,000,000

305,982 2.0 / = × =

As part of the basic approval the Group informed the applicant that it would be necessary to 

provide all necessary data including input parameters for the Group to be able to evaluate the 

risk assessment presented by the applicant. 

In evaluating the risk assessment presented for final approval, the Group encountered the same 

problems. It is unclear how the risk assessment was set up and carried out. Copies of the 

original input data and subsequent calculations would be required in order to allow the Group to 

reconstruct and evaluate the risk assessment. 
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Furthermore, the organic content (TOC) in test water was significantly lower than required 

by G8. The group considered that such conditions in the tests could reduce the probability of 

causing long term effects in the risk assessments, i.e. on continuous discharge. If the half life 

data indicated in Table 16 is used in the usual one box model considering exchange rate and 

degradation rate, the PEC value should be nearly twice that which the applicant indicated. 

8 ENVIRONMENTAL RISK ASSESSMENT 

8.1 PEC/PNEC calculation 

.................................................................................................................. 

(Paragraph deemed to be confidential and removed at the request of the submitting 

Administration) 

8.2 Risk Characterization 

.................................................................................................................. 

(Paragraph deemed to be confidential and removed at the request of the submitting 

Administration) 

9 CONCLUSIONS AND RECOMMENDATIONS 

9.1 Risks to the safety of the ship 

Risks to the safety of the ship from the production of hydrogen by the BWMS was reported by 

the applicant. The Group was satisfied that under the operating conditions described in this 

application, the concentrations of hydrogen produced during land based and shipboard testing 

remained at safe levels, i.e. less than one quarter of the LEL of 4%. In fully operational systems 

consideration should be given to monitoring hydrogen levels to ensure that they are not allowed 

to exceed such safe levels; ventilation should be considered. 

Chlorine gas was also measured in the land based (barge) and ship board tests and at 0.9 ppm 

was considered by the group to be close to published acute exposure limit. The group therefore 

considered that additional risk mitigation measures will be necessary immediately 

following treatment. 

The Group recommends that corrosivity continues to be monitored as part of the normal 

operation of the ECS system.

9.2 Risks to the crew and general public 

The Group concluded that Chlorinated and Brominated DBPs (Disinfection By-Products) are the 

toxicologically relevant compounds generated by the process as they have a potential for 

bioaccumulation and human genotoxicity/carcinogenicity; therefore they will have to be kept 

below toxicologically critical levels (bromate <10 μg/L, bromoform <100 μg/L, 

chloroform <200 μg/L, WHO Guidelines for Drinking Water Quality, 2003). 

The Group also noted that the applicant did not provide information concerning potential Human 

Exposures or any Exposure Scenario related to this BWMS (MEPC 56/2/2, annex 9) and that 

therefore an adequate conclusion as to the outcome of the Human Risk Assessment could not be 

made. In this sense, the Group adopted a precautionary approach and recommended that human 
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exposure when handling ballast water treatment operations should be restricted and Risk 

Mitigation Measures (RMM) put in place. 

9.3 Risks to the environment 

Given the current status of the proposals as presented in this application for Final Approval, 

risks to the aquatic environment cannot be excluded. Therefore, measures to lower the 

TRC levels discharged are required. 

9.4 Recommendations 

The Group concluded that the Korean application is not ready for final approval. In the report of 

the GESAMP-BWWG (1) the conclusions and recommendations are stated as follows: 

9.3 Mitigation procedures or operations should be established to reduce the TRC to 

levels that avoid risk to the environment in the case of short trips and during the 

treatment of fresh waters. 

9.4 It seems that the application of the ECS leads to creation of substantial amounts 

of very reactive species, in particular chlorine solutions that may lead to increased 

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

elucidated. 

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

process result in concentrations in the treated ballast water that largely 

exceed limit values established for discharge of waste water from land-based 

point sources. The degradation rate of TRC is so low that substantial 

concentrations may be expected also at discharge of treated ballast water. 

In addition, the potential health risks have not been sufficiently characterized. 

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

species immediately after treatment with ECS. The tests showed that a 

dilution of up to more than 100 times is required before acute toxicity can 

be avoided. 

• The assessment of environmental exposure concentrations have apparently 

been based directly on the same model calculations with the MAMPEC model 

as presented in the application dossier submitted by a separate applicant. 

The Group would require access to the input data and more information on 

the parameters within the model in order to ascertain the validity of the 

results. 

• The aquatic risk assessment based on the measured concentrations in treated 

ballast water, the dilution model assuming a dilution of approximately 2,000 

times and derived Predicted No-Effect-Concentrations for hypochlorite 

showed an estimated risk to the aquatic environment. 

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

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

included. 
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• The application dossier does not include documentation of the quality 

control/quality assurance programme as requested in G9: 4.2.4. 

9.5 After considering all of the above concerns, it is the opinion of the Group that the 

proposal has not demonstrated whether there is a potential for unreasonable risk for 

environment, human health, property and resources. The Group therefore considers it 

appropriate that further land-based studies be conducted before on board testing 

eventually takes place. Consequently, the Group recommends that the Organization 

should grant a basic approval to the proposed Electro Clean System with conditions that 

land-based testing address the concerns for short- and long-term impacts to the receiving 

waters before an eventual on-board testing is approved. 

The applicant is advised to revisit and address these recommendations. 

During the evaluation process and interactions with the Korean authorities it showed that 

research on the mitigation measures was still under testing for biological efficacy, influence to 

the environment and risk on crew and ship. 

The recommendations of the GESAMP-BWWG from its initial appraisal of this system are 

therefore still under development. 

Thus, insufficient progress has been achieved to clarify the concerns of the Group in the current 

submission for Final Approval. 

The Group recommends that first the final results of the mitigation measures are implemented 

into the proposal for Final Approval for subsequent consideration by the Group. 

* * * 
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APPENDIX 1 

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF HYPOCHLORITE, 

DIBROMOCHLOROMETHANE, TRIBROMOMETHANE, 

DIBROMOCHLOROACETIC ACID AND TRIBROMOACETIC ACID 

1 PHYSICOCHEMICAL PROPERTIES 

Table 17: Physical and chemical properties of hypochlorite 

(MEPC 57/2/1, 5.2.4) 

Property Value Reference

Melting point (°C) -25 IUCLID 

Boiling point (°C) 96-99 IUCLID 

Flammability Non flammable IUCLID 

Density (20°C; kg/m3) 1.21~1.23 IUCLID 

Vapour pressure (20°C ; Pa) 2500 IUCLID 

Vapour density (air = 1) N.A. MSDS 

Water solubility (temp; effect of 

pH; mg/L) Miscible (>11 and 20 oC) IUCLID 

pH in solution 14 MSDS 

Dissociation constant (pKa) N.A. - 

Oxidation-reduction potential N.A. - 

Corrosivity to material or 

equipment N.A. - 

Reactivity to container material N.A. - 

Auto-ignition temperature (°C) N.A. - 

Explosive properties N.A. - 

Oxidizing properties 

One of the more commonly used 

oxidizing agents and a very efficient 

disinfectant: virucide, bactericide and 

fungicide. It is used for the remnant 

disinfection of drinkable water 

IUCLID 

Surface tension N.A. - 

Viscosity Dynamic viscosity 20°C: 2.6mPa.s IUCLID 

Thermal stability and identity of 

breakdown products N.A. - 

Other physical or chemical 

properties N.A. - 
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Table 18: Physical and chemical properties of dibromochloromethane 

(MEPC 57/2/1, 5.3.4) 

Property Value Reference

Melting point (°C) -20 Lide 2000 

Boiling point (°C) 120 Lide 2000 

Flammability (flash point for 

liquids; °C) Non-flammable HSDB2004a, 2004b 

Density (kg/dm3, 20°C) 2.451 Lide 2000 

Vapour pressure (20°C ; Pa) 10,133 US EPA Mabey et al. 1982 

Vapour density (air = 1) No data IARC 1991a, 1991b 

Water solubility (temp; effect of 

pH; mg/L) 2.7x103

 (20°C) Horvath 1982; 

Heikes 1987 

Table 19: Physical and chemical properties of tribromomethane 

(MEPC 57/2/1, 5.4.4) 

Property Value Reference 

Melting point (°C) -11.87 EPI Suit V 3.20 

Boiling point (°C) 167.23 EPI Suit V 3.20 

Flammability Non-flammable HSDB 2004a ,2004b 

Density (20°C; kg/m3) 2.899 Lide, 2000 

Vapour pressure (25°C; Pa) 712 EPI Suit V 3.20 

Vapour density (air = 1) 8.7 IARC 1991a, 1991b 

Water solubility (mg/L) 3.10x103

 (25°C) 

Slightly soluble EPI Suit V 3.20 

Surface tension (dynes/cm) 41.53 Lewis 1997 

Viscosity (mPa.s) at 20°C : 0.58 MSDS 

Table 20: Physical and chemical properties of dibromoacetic acid 

(MEPC 57/2/1, 5.5.4) 

Property Value Reference

Melting point (°C) 49 Windholz et al., 1996; Lide, 1999 

Boiling point (°C) 195 Adapted Stein & Brown method 

Flammability N.A. N.A. 

Density (20°C; kg/dm3) N.A. N.A. 

Vapour pressure (25°C ; Pa) 3.1 N.A. 

Vapour density (air = 1) N.A. N.A. 

Water solubility (temp; effect 

of pH; (mg/L) 2.214x104 at 20  ̊C Windholz et al., 1996; Lide, 1999 
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Table 21: Physical and chemical properties of dibromoacetic acid (MEPC 57/2/1, 5.6.4) 

Property Value Reference 

Melting point (°C) 130-133 MSDS 

Boiling point (°C) 245 MSDS 

Flammability N.A. N.A. 

Density (20°C; kg/m3) - - 

Vapour pressure (20°C ; Pa) 6,666 US EPA Mabey et al, 1982 

Vapour density (air = 1) N.A. N.A. 

Water solubility (temp; effect of 

pH; (mg/L) 1.199x104

 (25°C) US EPA Mabey et al, 1985 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data 

Table 22: Acute aquatic toxicity of Active Substances and other chemicals 

(MEPC 57/2/1, tables 5-8, 5-20 and 5-32) 

F

C

A 

Species LC50 [mg/L] 

(duration) Reference

Hypochlorite F Pimephales 

promelas 5.9 (96hr) Curis, et al., 1981 

C Gammarus 

fasciatus 4.0 (96hr) Ewell et al., 1986 

A Chlorella 

sorokiniana 0.6 (20hr) Kott et al., 1969 

Dibromochloromethane F Cyprinus carpio 52 (0.75hr) Trns.Am.Fish.Soc. 

A Tetrahymena 

pyriformis 65 (24hr) Sci.Total Environ. 

Tribromomethane F Brevoortia 

tyrannus 12 (96hr) Quarterly Progress 

Report, 1978. 

C Penaeus aztecus 26 (96hr) Quarterly Progress 

Report, 1978. 

A Selenastrum 

capricornutum 40 (96hr) (EC50) Contract No.68-

01-4646,U.S. EPA 

However, the Group noted that no data was presented for hypobromous acid/hypobromite and 

hypochlorous acid. 
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2.2 Chronic aquatic toxicity data 

Table 23: Chronic aquatic toxicity of Active Substances and other chemicals 

(MEPC 57/2/1, tables 5-9, 5-21 and 5-33) 

F

C

A 

Species

LC50 or 

NOEC[mg/L] 

(duration)

Reference

Hypochlorite F Menidia 

beryl1ina NOEC: 0.18 (7d) Fisher et al., 1994 

C Dreissena 

polymorpha 295h-LC50: 1.0 Martin, I.D. et al., 

1993 

A Skeletonema 

costatum 

24h-EC50: 0.095 Gentile J.H. et al., 

1976 

Dibromochloromethane F Cyprinus carpio LC50: 34 (NR d) Trns.Am.Fish.Soc. 

A Tetrahymena 

pyriformis 24h-LC50 65 Sci.Total Environ. 

Tribromomethane F Cyprinodon 

variegatus 29h-NOEC 2.9 

Bull.Environ.Contam

.Toxicol. 

27(5):596-604 

(OECDG Data File) 

C Penaeus aztecus NR 0.030 (NR d) 

Pacific.NorthwestLa

b.,Richland.WA:40p 

(U.S.NTIS NUREG. 

CR-1297) 

A Selenastrum 

capicornutum 96h-NOEC 10 Contract No.68-01-

4646, U.S.EPA: 9p 

Dibromoacetic acid N.D. 

Tribromoacetic N.D. 

2.3 Information on production of endocrine disruption 

No information on production of endocrine disruption related to effect on aquatic organisms of 

hypochlorite, dibromoacetic acid and tribromoacetic acid is presented to assess this endpoint. 

Only some data are submitted about possible endocrine effects on mammals. 

The Group, however, considers these data as irrelevant as the intention of this topic is to 

safeguard the environment for such effects. The Group is of the opinion that: 

• There are no structural alerts as neither of these substances have structures which are 

known to trigger endocrine receptors, e.g., a benzene ring with an alcohol or ketone group 

in a near terminal position and backed by alkyl ‘bulk’. 

• Endocrine disruption in the true sense is restricted to hormones or pseudo-hormones with 

strengths 10-4 to 10-6 lower than predicted chronic aquatic values e.g. estrogen and 

synthetic estrogen, TBT, DES, etc. 
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Page 26 

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• Some inherent characteristics, e.g. vapour pressure, are considered high enough to reduce 

any potential endocrine disrupting effect to acceptable levels. 

Therefore, the Group concludes that no additional information is required on the topic of 

endocrine disruption for the substances used in this Ballast Water Treatment System under G9. 

2.4 Sediment toxicity 

There are no data available on the toxicity for sediment organisms, but based on table 24 

an estimation can be made on possible toxicological effects for these substances. 

Table 24: Summary of Log Pow and Koc values for potential sediment toxicity 

Compound Log Pow Koc Reference 

Dibromochloromethane 2.2 MEPC 57/2/1, 5.3.1.4 

Tribromomethane 2.4 35.04 CITI (1992), Sangster (1994) 

EPI Suit V 3.20 

MEPC 57/2/1, paragraph 5.4.1.4 

Dibromoacetic acid 0.7 1.895 EPI SuitTM, U.S.EPA v3.20 

MEPC 57/2/1, paragraph 5.5.1.4 

Tribromoacetic 1.71 0.437 EPI SuitTM, U.S.EPA v3.20 

MEPC 57/2/1, paragraph 5.6.1.4 

The Group agreed that due to the low Log Pow and Koc values being <3 and <500, respectively, 

the possibility of sediment toxicity would be predicted to be very low. 

2.5 Bioavailability/Bioconcentration/Biomagnification 

Table 25: Summary of Log Pow and BCF values for potential Bioavailability/ 

Bioconcentration/Biomagnification 

Compound Log Pow BCF Reference 

Hypochlorite -3.42 EPI SuitTM, U.S.EPA v3.20 

MEPC 57/2/1, paragraph 5.2.1.5 

Dibromochloromethane 2.2 MEPC 57/2/1, 5.3.1.5 

Tribromomethane 2.4 14.06 MEPC 57/2/1, 5.4.1.5 

Dibromoacetic acid 0.7 3.162 EPI SuitTM, U.S.EPA v3.20 

MEPC 57/2/1, 5.5.1.5 

Tribromoacetic 1.71 3.162 EPI SuitTM, U.S.EPA v3.20 

MEPC 57/2/1, 5.6.1.5 

The Group concludes from these data that none of these substances is expected to accumulate or 

magnify in the food chain. 

2.6 Food web/Population effects 

Reference is made to the low Log Pow and BCF values in Table 25. Because of the low Log 

Pow and Koc values being <3 and <500, respectively, the possibility of adverse effect on food 

web should be insignificant. 
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3 MAMMALIAN TOXICITY 

3.1 Acute mammalian toxicity 

Table 26: Summary of available data on mammalian toxicity 

Compound Unit Value Species Reference 

Hypochlorite Oral 

LD50

mg/kg 8200 Rat 

Kaestner, W., cited in 

BIBRA Toxicity 

Profile 

MEPC 57/2/1, 5.2.2.1 

Hypochlorite Dermal 

LD50

mg/L >10000 Rabbit Bio-fax data summary 

MEP C57/2/1, 5.2.2.1 

Hypochlorite Inhalation 

LC50

mg/L >10.5 Rat Bio-fax data summary 

MEPC 57/2/1, 5.2.2.1 

Dibromochloromethane 

Oral 

LD50

mg/kg 848-1186 Rat Chu I et al., 1980 

MEPC 57/2/1, 5.3.2.1 

Tribromomethane 

Oral 

LD50

mg/kg 1147 Rat Chu et al., 1982a 

MEPC 57/2/1, 5.4.2.1 

Tribromomethane 

Inhalation 

LC50

mg/L 

Classified as

toxicant by 

inhalation 

Annex VI, COM (2007) 355 

final 

Dibromoacetic 

acid 

Oral 

LD50

mg/L L 4480 Rat Woodard et al., 1941 

MEPC 57/2/1, 5.5.2.1 

Tribromoacetic acid N.D. 

According to the presented data, hypochlorite is considered to be harmful by inhalation and 

dibromochloromethane, tribromomethane by oral exposure. On the other hand, tribromomethane 

is classified as toxicant by inhalation (GHS classification, Annex VI, COM (2007) 355 final). 

Additionally, dibromoacetic acid, is not considered to be an acute toxicant by oral route and for 

tribromo-acetic acid, no data was submitted to assess acute toxicity. 
GESAMP-BWWG 4/9 

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3.2 Corrosion/Irritation 

Table 27: Summary of available data effects on skin and eye 

 Species Method Results (including 

scores where available) Reference

Hypochlorite Skin Rabbit OECD 404 Irritating, 2%: 1.2, 20%: 

5.3, 35%: 5.2, 50%: 5.3 

Loden, M. et al., 

1985 

MEPC 57/2/1, 

5.2.2.2 

Hypochlorite Eye Rabbit - Irritating, Draize score : 

11 (0.01Ml), 40 (0.1Ml) 

Chan, K. Y., 1985 

MEPC 57/2/1, 

5.2.2.2 

Hypochlorite Skin Human Patch test sensitizer 

Osmundsen, P.E., 

1978 

MEPC 57/2/1, 

5.2.2.2 

Dibromochloromethane 

Skin 

Rats 

and 

mice 

Gavage 

for up to 

2 years 

No histological 

alterations were found 

in the skin of rats and 

mice 

NTP1985,1989a 

MEPC 57/2/1, 

5.3.2.2 

Dibromochloromethane 

Eye 

Rats 

and 

mice 

Gavage 

for up to 

2 years 

No histological 

alterations were found 

in the skin of rats and 

mice 

NTP 1985,1989a 

MEPC 57/2/1, 

5.3.2.2 

Tribromomethane Skin 

Rats 

and 

mice 

- Classified as an irritant Annex VI, COM 

(2007) 355 final

Tribromomethane Eye 

Rats 

and 

mice 

- Classified as an irritant 

(serious eye irritation) 

Annex VI, COM 

(2007) 355 final

Tribromoacetic acid 

Skin 

and 

eye 

humans Corrosive effect 

MSDS of 

tribromoacetic acid

MEPC 57/2/1, 

5.6.2.2 

According to the presented data, hypochlorite is classified as a skin and eye irritant and a 

sensitizer. Additionally, tribromo-acetic acid is considered to be corrosive to skin and eye. 

tribromo-methane is classified as skin and eye irritant, causing serious eye irritation 

(GHS classification, Annex VI, COM (2007) 355 final). 
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3.3 Repeated-dose toxicity 

Table 28: Repeated-dose toxicity of hypochlorite (MEPC 57/2/1, 5.2.2.4) 

Exposure Route Drinking water 

Exposure Duration 12 months 

Exposure dose 1, 10 or 100 mg/L 

Species Rat 

Method - 

Results Decrease of blood glutathione with 10 or 100 mg/L, increase of 

osmotic fragility after 6 months. In animals exposed for 3 months, 

the 3H-thymidine incorporation into nuclei of rat kidney and testes in 

the 100 mg/L group was increased. 

Reference Abdel-Rahman, M.S. et al., 1984 

Table 29: Repeated-dose toxicity of dibromochloromethane (MEPC 57/2/1, 5.3.2.4) 

Exposure Route Feeding 

Exposure Duration 90 days 

Exposure dose 0, 50, 100 and 200 mg 

Species Rat 

Method - 

Results No changes were found in mortality, clinical signs, 

ophthalmoscopic examinations considered to be related to 

treatment. Mean final body weight and body weight gain were 

significantly decreased in male and female high dose animals 

relative to the vehicle control. 

Reference Daniel FB, 1990 

Table 30: Repeated-dose toxicity of tribromomethane (MEPC 57/2/1, 5.4.2.4) 

Exposure Route Receiving gavage 

Exposure Duration 2 years 

Exposure dose 200 mg/kg (5d/week) 

Species Rats and mice 

Method - 

Results No significant histopathological alterations were detected 

NOAEL N.A. 

NOEL N.A. 

Reference NTP(1989a) 
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Table 31: Repeated-dose toxicity of dibromoacetic acid (MEPC 57/2/1, 5.5.2.4) 

Exposure Route Gavage 

Exposure 

Duration 14 days 

Exposure dose 0, 5, 50, or 250 mg/kg of body weight per day 

Species Rats 

Method - 

Results No effects on body or testicular weights, however epididymal weight 

in the 250 mg/kg group was significantly lower than that of the control 

group 

Reference Tsuchiya T et al., 2000 

Table 32: Repeated-dose toxicity of tribromoacetic acid (MEPC 57/2/1, 5.6.2.4) 

Exposure Route Drinking water 

Exposure 

Duration 2 weeks 

Exposure dose 0, 30, 100, 300 and 500 mg/L 

Species Rats 

Method - 

Results During the treatment period, all animals survived to the scheduled 

necropsy and there were no clinical signs of general toxicity noted at any 

dose level. There were no treatment-related findings in body weights or 

feed consumption, but there was a slight and inconsistent decrease in 

water consumption in the 500 mg/L animals. 

Reference NTP Study Number: RDGT94009 

According to the presented data, there seemed to be no relevant toxicological concerns towards 

repeated exposure to hypochlorite, dibromo- and tribromochloromethane, dibromo- and 

tribromoacetic acid. 

3.4 Development and reproductive toxicity 

Table 33: Development and reproductive toxicity test of hypochlorite 

(MEPC 57/2/1, 5.2.2.5) 

Exposure Route Drinking water 

Exposure Duration 6 months 

Exposure dose 10 mg/L residual chlorine 

Species Mouse 

Method Fertility test 

Results No detrimental effects on reproduction. 

NOAEL N.A. 

NOEL N.A. 

Reference Les, E. P., 1968 
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Table 34: Development and reproductive toxicity test of dibromochloromethane 

(MEPC 57/2/1, 5.3.2.5) 

Exposure Route GO (gavage oil) 

Exposure Duration days 6 to 15 of gestation 

Exposure dose 200 mg/kg 

Species Rat 

Method - 

Results No alteration in the number of resorption sites, fetuses per litter, fetal 

body weights fetal gross malformations, or skeletal or visceral 

anomalies were found. 

NOAEL 200 mg/kg d 

NOEL N.A. 

Reference Ruddick et al. (1983) 

Table 35: Development and reproductive toxicity test of tribromomethane 

(MEPC 57/2/1, 5.4.2.5) 

Exposure Route GO (gavage oil) 

Exposure Duration days 6 to 15 of gestation 

Exposure dose 200 mg/kg 

Species Rat 

Method - 

Results Increase in the occurrence of skeletal anomalies in offspring of rats 

NOAEL 100 mg/kg d 

Reference Ruddick et al. (1983) 

Table 36: Development and reproductive toxicity test of dibromoacetic acid 

(MEPC 57/2/1, 5.5.2.5) 

Exposure Route Drinking water 

Exposure 

Duration 

P generation male rats, approx 92 days 

P generation female rats, through gestation and a 29-day lactation period

F1 generation exposed in utero and during lactation, postweaning/premating exposure of min 71 days (through mating, gestation 

and lactation) 

Exposure dose 0, 50, 250 or 650 mg/L (0, 4.4 to 11.6, 22.4 to 55.6, and 52.4 to 132.0

mg/kg/day) 

 

Species Sprague-Dawley rats (2-generations) 

Method N.A. 

Results Reproductive effects were seen in high dose F1 males: a significant 

increase in the unilateral malformation of the reproductive tract 

(small or absent epididymides and small testis) was observed. 

NOAEL <22,4 mg/kg bw/day [<250 mg/L] 

Reference Christian et al., 2002 
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ANNEX 4 

Page 32 

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Table 37: Development and reproductive toxicity test of tribromoacetic acid 

(MEPC 57/2/1, 5.6.2.5) 

Exposure Route Drinking water 

Exposure 

Duration 

2 weeks 

Exposure dose 39 mg/kg/day 

Species Rats 

Method N.A. 

Results Female and male reproductive findings were not considered to be 

treatment related. 

Reference NTP Study Number: RDGT94009 

From the submitted data, some reproduction toxicological effects were observed however these 

were associated to exposure to high doses. 

3.5 Carcinogenicity 

Table 38: Data on carcinogenicity 

 Species Method Results Reference

Hypochlorite Mice Dermal No skin tumors, 

no leucemia. 

Hayatsu, H. et al., 

1971 

MEPC 57/2/1, 

5.2.2.6 

Dibromochloromethane 

Mice gavage doses of 100mg/kg, 

5 days/ week for 2 years 

Increases in the 

incidences of 

hepatocellular 

adenomas and 

carcinomas 

NTP 1985 

MEPC 57/2/1, 

5.3.2.6 

Tribromomethane 

Rats 

and 

mice 

tribromomethanee in corn 

oil by gavage 5 days/week 

for 2 years 

Not available 

NTP, 1988 

MEPC 57/2/1, 

5.4.2.6 

Dibromoacetic acid 

Rats 

and 

mice 

Exposure to dibromoacetic 

acid in drinking water for 2 

weeks, 3 months, or 2 

years. Concentrations were 

0, 125, 250, 500, 1000, and 

2000 mg/L 

Toxic effects of 

dibromoacetic 

acid in the 

prechronic 

studies were 

detected in the 

liver and testes. 

Ronald L et al., 

2007 

MEPC 57/2/1, 

5.5.2.6 

Tribromoacetic acid N.D. 

Relevant adverse effects related to target organs (liver and testis) were observed in the presented 

data. Chlorinated and Brominated DPB, have a potential for bioaccumulation and human 

genotoxicity/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). 
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3.6 Mutagenicity 

Table 39: Data on mutagenicity 

 Species Method Details Results Reference

Hypochlorite Mice Gavage Negative 

Meier, J.R. et al.,

1985 

MEPC 57/2/1, 5.2.2.6 

Dibromochlor

omethane 

Rats and

mice - Positive Melnick et al 1998 MEPC 57/2/1, 5.3.2.6 

Tribromomethane Rat and

mice - Positive Melnick et al 1998 MEPC 57/2/1, 5.4.2.6 

Dibromoacetic 

acid Mice Orally via drinking water for 13 weeks 

Detailed results 

of the study are 

not available at 

this time. 

NTP, 2003c 

MEPC 57/2/1, 5.5.2.6 

Tribromoaceti

c acid 

Salmone

lla - positive Knasmuller,1999 MEPC 57/2/1, 5.6.2.6 

Chlorinated and Brominated DPB, has a potential for bioaccumulation and human 

genotoxicity/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) 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic) 

4.1.1 Hydrolysis (Ref. MEPC 57/2/1, 5.2.3.1.2) 

Hypochlorite decomposes slowly on standing with the evolution of oxygen. Factors that 

increase the rate of decomposition are: high initial concentration, increase in temperature, 

certain metallic impurities, drop in pH below 11 and exposure to light. 
GESAMP-BWWG 4/9 

ANNEX 4 

Page 34 

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Table 40: Decomposition of THM and HAA 

Seawater 

or Fresh 

water 

dura

tion Results 

Breakdown 

products 

Reference 

Dibromochloromethane

Hydrolysis 

Chlorinated 

water 

28 d 

The 

concentration of 

dibromochloromethane 

decreased from 

46 μg/L to 3 μg/L

- 

Nicholson et al. 

2002 

MEPC 57/2/1, 

5.3.3.1 

Tribromochloromethane

Hydrolysis Chlorinated water 7 d 

Decreased from 

58 μg/L to <1 

μg/L 

N.A. 

Nicholson et al. 

2002 

MEPC 57/2/1, 

5.4.3.1 

Tribromochloromethane 

Biodegradation N.A. N.A. Increase in 

degradation 

Dibromo

-methane 

Kenneke et al. 

2003; Pecher et al

2002 

MEPC 57/2/1, 

5.4.3.1 

Tribromochloromethane 

Half-life Fresh 

water N.A. 5.836 h N.A.

EPI Suit V 3.20 

MEPC 57/2/1, 

5.4.3.1

Dibromoacetic acid Biodegradation Drinking 

water 6 m 

Biodegradation 

was observed for 

each of the 

HAAs 

Chloride 

Bethany, 2004 

MEPC 57/2/1, 

5.5.3.1 

Tribromoacetic acid 

Biodegradation 

under 

aerobic 

conditions 

Drinking 

water 6 m 

Biodegradation 

was observed for 

each of the 

HAAs 

Chloride 

Bethany, 2004 

MEPC 57/2/1, 

5.6.3.1 
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4.1.2 Biodegradability (biotic/abiotic) 

4.1.3 Bioaccumulation, partition coefficients, octanol/water partition coefficient 

Table 41 : Bioaccumulation, partition coefficients, octanol/water partition coefficient 

 Log Pow Koc Bioaccumulative Reference

Hypochlorite -3.42 14.3 

No 

Log Pow: -3.42 

BCF: 3.16 

Appl. For FA. 5.6.4 p. 101 

MEPC 57/2/1, 5.2.3.2 

Dibromochlor

omethane 2.16 No BCF: 9.188 

Kaczmar et al. 1984 

Mackay et al. 1982 

MEPC 57/2/1, 5.3.3.2 

Tribromomethane 2.4 35.04 No 

BCF: 14.06 

Kaczmar et al. 1984 

Mackay et al. 1982 

MEPC 57/2/1, 5.4.3.2 

Dibromoacetic acid 0.7 1.895 No 

BCF: 3.162 

EPI Suit V 3.20 

MEPC 57/2/1, 5.5.3.2 

Tribromoacetic acid 1.71 0.437 No 

BCF: 3.162 

EPI SUIT V3.20 

MEPC 57/2/1, 5.6.3.2 

4.2 Partition Coefficients

4.3 Persistence and identification of main metabolites 

Because of low Log Pow and no bioaccumulating properties, there was no report on persistence 

and identification of main metabolites of hypochlorite.

Table 42: Persistence 

 Persistent Half-life Reference

Hypochlorite No MEPC 57/2/1, 

5.2.3.1.1 

Dibromochloromethane No flowing aerated water: 

0.7-398 h 

Kaczmar et al. 1984 

Mackay et al. 1982 

MEPC 57/2/1, 5.3.5.2 

Tribromomethane No flowing aerated water: 

1-581 h 

Kaczmar et al. 1984 

Mackay et al. 1982 

MEPC 57/2/1, 5.4.5.2 

Dibromoacetic acid No EPI Suit V 3.20 

MEPC 57/2/1, 5.5.5.2 

Tribromoacetic acid No EPI SUIT V3.20 

MEPC 57/2/1, 5.5.5.2 

4.4 Reaction with organic matter 

When natural organic matter is treated with hypochlorite compounds (HOCl, OCl-), high 

molecular weight chlorinated compounds form in a first step that is followed by the cleavage of 

benzene rings into trihalomethanes and haloacetic acids. Sodium hypochlorite treated humic 

acid yielded more chloroform than treated fulvic acid. 
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4.5 Potential physical effects on wildlife and benthic habitats 

4.5.1 Sodium hypochlorite is miscible to water (IUCLID, 2000) so it doesn’t affect physical 

wildlife and benthic habitats. 

4.5.2 For all other by-products (dibromochloromethane, tribromomethane, dibromoacetic acid 

and tribromoacetic acid) the Applicant concludes that due to the density of the compounds and 

their slight solubility in water there could be a potential physical effect on wildlife and 

benthic habits 

4.6 Potential residues in seafood 

No data on potential residues in seafood of all identified by-products is available. 

The Applicant assumes low potential for residues in seafood. 
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5 OTHER INFORMATION

5.1 Analytical Methods for Measuring the Concentration at environmentally Relevant 

Concentrations 

Table 43: Analytical methods 

Hypochlorite Method DPD method 

Applicability Yes 

Sensitivity Two Ranges: LR – 0.02 to 2.00mg/L and HR – 0.1 to 

8.0mg/L as Cl2 

Reference 

Standard Methods for the Examination of Water and Waste 

Water, 18th edition, American Public Health Association 

(APHA), MEPC 57/2/1, 5.2.5.1 

Dibromochloro

methane Method GC/HSD (gas chromatography – halide specific detector) 

Applicability Contaminated soil 

Sensitivity 

Sample detection limit: 0.9 μg/kg/Accuracy (percent 

recovery): 94 

MEPC 57/2/1, 5.3.5.1 

Reference EPA 1986a 

Tribromomethane Method GC-HSD (gas chromatography – halide specific detector) 

Applicability Contaminated soil 

Sensitivity Sample detection limit: 2 μg/kg/Accuracy (percent 

recovery): 96 

Reference EPA 1986a, MEPC 57/2/1, 5.4.5.1 

Dibromoacetic acid Method GC/ECD (Gas chromatography- Electron capture detector) 

Applicability Contaminated water 

Sensitivity Accuracy: 93-116% (US EPA method standard) 

Reference US EPA 552.2, MEPC 57/2/1, 5.5.5.1 

Tribromoacetic acid Method GC/ECD (Gas chromatography- Electron capture detector) 

Applicability Contaminated water 

Sensitivity Accuracy: 93~116% (US EPA method standard) 

Reference US EPA 552.2, MEPC 57/2/1, 5.6.5.1 

5.2 Material Safety Data Sheet provided: Yes 

5.3 GHS Classification: unknown 

5.4 Risk Characterization

***

GESAMP-BWWG 4/9 

I:\MEPC\57\2.doc 

ANNEX 5 

REVIEW OF PROPOSAL FOR BASIC APPROVAL OF ACTIVE SUBSTANCE 

Hitachi Ballast Water Purification System – Clear Ballast 

Submitted for Basic Approval by Japan as MEPC 57/2/2 

0 SUMMARY 

0.1 Basic approval of the Hitachi ballast Water Purification System (Clear Ballast) 

submitted by Japan is recommended to be granted. 

0.2 The system is based on standard drinking water purification technology, specifically the 

flocculation of suspended organic matter by iron tetraoxide and poly aluminium chloride 

combined with polyacrylamide. Recovery of the floc is achieved by the use of magnetic disks 

which attract the iron component of the floc, presumably allowing quicker separation. 

An attractive aspect of the system is that it uses no biocides and where the environment is 

concerned, the chemicals employed are relatively harmless. 

0.3 The active substances are well known and have a large literature in terms of human and 

environmental health; the WHO Guidelines on the treatment of drinking water provide good 

background information in this regard. 

0.4 The working group recommended that the applicant pay careful attention to the following 

points in order to address a wide range of safety considerations before final approval can be 

granted in the future: 

.1 An adequate quality assurance program needs to be developed for the entire 

system. 

.2 For final approval, the human health risks of the system will be evaluated by the 

GESAMP BWWG on the basis of its individual unit operations, i.e. each 

component of the system requiring operator attention. The manufacturer is 

therefore requested to describe separately the potential human health risks 

associated with each major component of the system and to describe the measures 

necessary to prevent human exposure for each such component. In particular, the 

methods employed for the collection, treatment and disposal of floc and their 

potential for occupational exposure need to be described. Additionally, the 

recommended risk reduction measures need clear explanation and documentation, 

e.g., for each procedure such as floc collection, dewatering, drying, incineration, 

sterilization, storage and disposal in whatever form. 

.3 The storage and handling of the three active substances on board needs to be 

carefully controlled and the proposed safety measures adequately documented, 

particularly bearing in mind the corrosive properties of poly aluminium chloride. 

.4 One major human health issue regarding the active substances relates to the 

residual acrylamide monomer contained in the polyacrylamide, which has a range 

of associated human health hazards and which, in parallel to best practices in 

drinking water purification, needs to be maintained at appropriately low 

concentrations. The quality of the polyacrylamide active substance needs to be 

strictly controlled and included in the QA program to ensure acceptably low 

concentrations of acrylamide monomer. 
GESAMP-BWWG 4/9 

ANNEX 5 

Page 2 

I:\MEPC\57\2.doc 

.5 The BWM system appears from the technical description to be partly open, 

allowing for possible occupational exposure to the crew to system processes and 

waste. This is a potential weakness of the system that remains to be adequately 

addressed. 

.6 Human health issues related to the potential concentration of pathogens in the 

flocs need to be examined and assessed in detail. The flocs could under heavily 

polluted intake conditions, have the potential to form a biohazard. 

.7 Adequate separation of the flocs from the treated water is crucial to the successful 

operation for the system. When scaling up to larger treatment capacities, this 

aspect must be addressed by the applicant, to ensure the human and environmental 

risks of the treated ballast water remains acceptable. 

.8 The positioning and operation of the proposed pre-filtration, as well as post 

filtration and its residue feedback system must be better described and 

documented. The procedures and processes for routine system maintenance, 

emergency procedures, filter and sludge conveyor cleaning, and the treatment and 

handling of the sludge must be defined and detailed. 

.9 The risk to the marine environment from the residual active substances must be 

assessed. Concentrations of heavy metals, aluminium, iron, acrylamide monomer, 

VOCs, and faecal coliforms must be measured in the intake water, collected 

sludge and the discharged ballast water from the representative ballast waters 

associated with testing under G8. The environmental risks of discharging 

polyacrylamide, a non-biodegradable polymer to shore and any subsequent 

disposal restrictions must be assessed. 

.10 Disposal of the collected sludge to shore-based waste reception facilities should 

be according to the relevant IMO regulations. The availability of suitable harbour 

reception facilities needs to be considered. 

.11 Additional toxicity testing of the treated Ballast Water should be performed using 

an appropriate range of conditions. 

.12 The risk assessment carried out by the applicant in the submission cannot be 

accepted by the GESAMP-BWWG, as it is unclear how the risk assessment was 

performed and how the both PEC and PNEC of concentration for Aluminium-ions 

and other relevant chemicals have been established. The Group therefore 

recommends to the MEPC to request the applicant to prepare a revised risk 

assessment for consideration in any application for Final Approval. 

.13 The maximum allowable discharge concentration should be set against the 

parameters that can be measured at such low levels. According to the applicant, it 

is difficult to measure the amount of PASA directly, if its concentration in water 

is low. This situation is considered to be unsatisfactory by the Group and an 

acceptable analytical method should be developed for confirming the maximum 

allowable discharge concentration for relevant parameters. 
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0.5 As there may be a risk to the ship of flooding through the sludge discharge arrangements 

should equipment malfunction occur, this possibility should receive additional consideration and 

assessment of the actual risk involved prior to shipboard installation. 

1 INTRODUCTION 

1.1 The data for this document were extracted from the original data supplied by Japan to 

support its submission MEPC 57/2/2. Furthermore, the document describes the Hitachi Ballast 

Water Purification System and its impact on the environment. This system uses coagulation and 

magnetic separation as the major purification method in accordance with the Procedure (G9). 

2 COMPLETENESS OF THE DOSSIER 

2.1 The Group noted that the applicant had provided a full description of the system in the 

submission including: 

.1 a general description of the ClearBallast system and its components; 

.2 a description of the use of the chemical injectors, coagulators, magnetic and filter 

separators and the sludge storage tank; 

.3 data on performance of the system; 

.4 a detailed description of the way the pH of the treated ballast water changes; 

 

.5 information about the active substances used in the ballast water treatment 

although the handling was not sufficiently described (where and when human 

exposure occurs); and 

.6 chemical and toxicological analysis reports of the treated ballast water, it is noted 

however that copies of the laboratory certificates were not provided. 

Abbreviations 

2.2 PAC (Poly Aluminium Chloride): An inorganic coagulant consisting of poly 

aluminium chloride and referring to basic aluminium chloride. 

2.3 PASA (Poly Acrylamide Sodium Acrylate): A cross linking chemical consisting of 

high molecular weight polymer particles with a negatively charged surface, which forms a 

coagulation of fine particles suspended in water such as a suspension colloid. It is a kind of 

Anionic High-Polymer Coagulant. 

2.4 SS (Suspended Solids): Particulate substances in water which are insoluble in water 

such as a suspension or colloid. Suspended solids are one of the indices that express the extent of 

suspension in water. 
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3 DESCRIPTION OF RESOURCE BALLAST TECHNOLOGIES SYSTEM 

3.1 Description of the ballast water management system 

According to the applicant, the ClearBallast System purifies water by removing target organisms 

and other objects using flocculating agents. It is advised that the system effectively promotes 

collision between these small target organisms and aggregates to form flocs, and separates the 

floc by magnetic separation technology to purify ballast water. The submission states that the 

system efficiently removes suspended solids, as well as bacteria and plankton. The group noted 

that the efficiency of the total removal process of PAC as Aluminium amounted to a minimum of 

about 98.4%. The Group recognized that the applicant applies the same number of removal 

efficacy for risk characterization of other active substances and relevant chemicals, such as 

PASA and its impurity; acrylamide monomer. However, the group noted that this estimation for 

any substances other than Aluminium should be reviewed by the actual measurement results 

and/or mass flow analysis of substances. 

3. 1.1 Principle of purification of the system 

This system employs a coagulation and magnetic separation method, in which organisms and 

other target objects are coagulated using coagulants and separated by magnetic separation 

technology. Specifically, coagulants and triiron tetraoxide are added to the seawater to form 

small agglomerates of about 1 mm in diameter called flocs, containing plankton, bacteria and 

sand. These flocs are then separated from the seawater using permanent magnets. Finally, any 

flocs not removed by the magnetic separation are removed by a rotating filter drum. 

PAC

and

PASA

Triiron tetraoxide Plankton

Bacteria

Figure 1: Schematic structure of a floc 

It is noted that the proposal states that the ballast water can be treated either during storage in the 

ballast tank, during intake, or during discharge. Purification during intake is stated to be the most 

effective way to ensure that a minimal amount of organisms and SS enter the ballast tanks and 

thus reduces sediment build-up in the tanks. The results provided relate to operations for 

purification during intake. 

System Process 

The active substances are mixed in separate slurry mixers prior to individual injection into the 

system. The coagulation phase consists of a Flash mixer followed by a Flocculation reactor. 

The triiron tetraoxide and PAC slurries are injected into the ballast water prior to the Flash mixer. 

PASA is supplied as either a liquid or a dry powder which is mixed into a slurry and is injected 

into the ballast water after the Flash mixer and prior to the Flocculation reactor where the ballast 

water is retained for a period to achieve flocculation of the impurities. The flocs are then 

removed on a magnetic disc array where the sludge so generated is led away to a sludge tank by a 
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conveyor. The ballast water is then fine filtered in a rotating filter drum before being directed to 

the ballast tank. The filtered material from the final filter is sent to a holding tank prior to being 

re-introduced to the system at the start of the process for re-treatment. The submission informs 

that it is intended at present for the waste sludge generated to be temporarily stored on board 

prior to packing, or drying and packing and then landed ashore. The submission states that the 

system is fully automated so that the only manual handling required is during loading of the 

chemicals to the storage tanks and during packing and handling of the process sludge to land. 

3.2 Active Substances, Relevant Chemicals and Other Chemicals

3.2.1 Active Substances 

Triiron tetraoxide, PAC, and PASA correspond to Active Substances (Table 1). The submission 

states that “in this purification system, since almost all the additive agents collected in the flocs 

are removed, the amount of Active Substances released into the environment together with the 

treated ballast water is negligible”. The Group is of the opinion that this statement requires 

further analytical verification. 

Table 1: Active Substances (Ref. MEPC 57/2/2, 5.1.2 table 5-1) 

Active 

Substance 1 Active Substance 2 Active Substance 3 

Name of substance 

(IUPAC) 

Triiron 

tetraoxide 

Polyaluminum 

chloride 

Acrylamide sodium acrylate 

copolymer 

Synonym (used in 

this document) 

Triiron 

tetraoxide 

PAC PASA 

CAS number 1317-61-9 1327-41-9 25085-02-3 

UN number None None None 

Shipping name None None None 

Molar weight 231.53 Not applicable More than several million 

Empirical formula 

or structural 

formula 

Fe3O4 Aln(OH)mCl(3n-m)

0<m<3n 

CH2 CH n CH2 CH m

CONH2 COONa

Purity 100% Percent of content: 

10-11% of water 

solution 

(aluminium oxide 

equivalent) 

90% or more 

Impurity None None Acrylamide monomer: 

0.05% or less 

(CAS No. 79-06-1) 

Stabilizers or 

additives 

None None None 
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3.2.3 Relevant substances (Ref. MEPC 57/2/2, 5.1.4) 

The group considered that the acrylamide monomers contained in PASA as an impurity are 

relevant to the hazard and risk assessment. The Group noted that although the mass 

concentration is only 0.05% or less of PASA, a data survey against the Quality for PASA 

production was nevertheless performed by the applicant. 

4 HUMAN HEALTH ASSESSMENT

The Group considers that there is a potential risk of short-term exposure to humans concerning 

the active substances (PAC and PASA) due to manual operations that can take place during the 

process, namely, pouring the chemicals into the storage tank and preparing for unloading of 

the sludge. 

The major concerns for PAC are the irritating properties (MSDS, 2003) and for PASA the 

toxicity of the residual acrylamide monomers. Therefore, during those exposure situations 

workers are recommended to wear protective gear (PPE and RPE). 

Additionally, the Group wants to stress that according to the scientific literature 

(EU, 2002; CIR, 2005), there is a critical human health concern related to exposure towards 

acrylamide monomers. 

The Group also noted that acrylamide monomers content were measured in the untreated and 

treated BW however the relevant measurements to be made in terms of human exposure should 

be conducted in the sludge and other materials where the concentration of potentially toxic 

compounds can occur (pathogens, metals). 

However, the Group noted that a detailed description of the handling operator tasks was missing 

and therefore an appropriate quantitative human health risk assessment could not be performed 

Figure 2 could serve as a basis for defining tasks that may pose a risk of human exposure. 
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B 

C + D 

Seawater Ballast

pump

Magnetic

separator

PASA

Chemical injectors

Filter separator Ballast tank

P

Filter washing water

Residue from filter

P Filter residue tank

Sludge

Sludge tank

Flash

mixer

Flocculation

reactor

Triiron

tetraoxide

&

PAC

Chemical injector

Coagulator

A 

E 

 

 F 

 G 

Figure 2: Tasks that may pose a human exposure risk 

A – adding coagulants (PAC, PASA) & triiron tetraoxide 

B – potential aerosols emitting from magnetic separators 

C – maintenance of sludge conveyor and sludge collection process 

D – aerosols from sludge drying and dry sludge processing 

E – transferring the wet sludge into containers 

 F – handling of containers for unloading 

 G – processing of waste ashore 

5 RISK TO SAFETY OF SHIP AND CREW 

The submission states that there is no risk to ship safety as the physical properties of the active 

substances are “not corrosive, do not react with the storage tank, do not ignite spontaneously, do 

not vaporize, and do not have oxidizing properties under the assumed on-board circumstances.”. 

This may be correct when the active substances have been diluted for injection to the system, 

however, the MSDS for PAC informs that it has a pH of 2-3, is corrosive and requires 

appropriate safety precautions for storage and handling. It is noted that the proposal requires this 

material to be loaded into storage tanks made of plastic, or lined with plastic on the inner surface 

to prevent corrosion of the tank due to contact with the acidic chemical and also acid resistant 

materials are required to be used for feeding pipes. A save-all is also to be provided around the 

PAC storage tank to contain leakage. The Group considers that the risk of corrosion from the 

storage of PAC to the ships structure has been adequately considered and appropriate 

precautionary measures are proposed. It should be ensured that the safety measures that have 

been identified are correctly implemented and followed for shipboard installation. 

The operational parameters of the magnetic disc array together with its conveyor system for 

sludge discharge and the rotating filter drum are not fully described in the submission. As it is 

possible that these components may be required to operate at atmospheric pressure it is 

considered that it may be necessary to incorporate appropriate safety measures to the shipboard 

installation to prevent flooding should equipment malfunction occur. 
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The submission informs that the process is automated and that manual handling of the active 

substances is limited to the loading of the storage tanks. 

The use of PPE is stipulated when the chemicals are poured into the storage tank and a notice 

regarding the use of appropriate protective gear is to be placed on the injector. It is also informed 

that to prevent scattering of the powder, the storage tank and piping are equipped with safety 

valves and tightly sealed and that a forced ventilation exhaust duct is to be provided close to the 

storage tank prevents any spilled dust from scattering. The group considers that the applicant has 

identified the risks inherent in the loading of the active substances to the storage tanks and that 

appropriate mitigation measures are proposed. It may also be appropriate to additionally 

consider the provision of washing facilities as identified in the MSDS for PAC in the vicinity of 

the storage facility and the positioning of the storage space air exhaust vent outlets. 

The possibility of the risks arising to the crew exposure from aerosols potentially emitted from 

the slurry mixing tanks, the magnetic disc array, the rotating filter drum, and the sludge transport 

and handling arrangements, including any sludge drying operations requires to be considered and 

appropriate safety mitigation measures introduced. 

The submission informs that the flocs extracted form a sludge consisting of chemicals, SS, 

plankton, bacteria, etc. Contact with this sludge should therefore be considered a potential risk to 

human health, and appropriate risk mitigation measures are required to be implemented, 

additionally to those already defined, where human exposure may be anticipated. Maintenance 

procedures, especially to the sludge conveyor and sludge processing equipment may be of 

particular relevance in this regard. 

It is noted that the present consideration for the disposal of the sludge generated is to temporarily 

store the sludge on board, then to transfer to individual containers or remove the water content 

with driers prior to unloading to land. As the discharge of ships’ waste to shore reception 

facilities is regulated under the various MARPOL Annexes, dependant upon the classification of 

the waste, further analysis of the sludge generated will be required so as to ensure appropriate 

handling and treatment. 

The availability of suitable reception facilities will require further careful consideration to ensure 

timely disposal from a ship fitted with this ballast water treatment system can be achieved. 

6 RISKS TO THE AQUATIC ENVIRONMENT 

6.1 Persistence (MEPC 57/2/3, 8.1.1) 

Triiron tetraoxide and PAC are inorganic compounds so that hydrolysis and biodegradability are 

not applicable. Triiron tetraoxide occurs naturally and PAC dissociates into chloride and 

aluminium ions. 

PASA is persistent and is not easily biodegraded. PASA was hardly degraded after 300 h and is 

not readily hydrolysed in the aquatic environment. Other literature states that degradation of 

PASA may take several years (Khaitan et al., 2003)1. 

 

1 Khaitan, S., Erickson, L.E., Hutchinson, S.L. & Karthikleyan, R. (2003) Biodegradation of Hydrocarbons 

in a Soil Containing Polyacrylamide. Proceedings of the 10th Annual Petroleum Environmental 

Conference, 10 November 2003, Houston, USA. 
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Acrylamide monomers hydrolysis half-life is >1 year, but they are biodegradable with a half-life 

of 33-55 h in water and in 18-95 h in soils. Therefore, acrylamide monomer is not considered a 

persistent substance. 

6.1.2 Bioaccumulation (MEPC 57/2/3, 8.1.2) 

Triiron tetraoxide is not considered to bioaccumulate in living organisms. 

For PAC the bioaccumulation of aluminium salts has been investigated. BCF values of 

aluminium are between 76 and 190 for marine fish and between 36 and 123 for freshwater fish. 

Therefore, PAC is not considered to bioaccumulate to significant extent. 

6.1.3 Toxicity tests 

For triiron tetraoxide no ecotoxicological data are available, but the group is of the opinion that 

these data are not needed because of the inorganic nature of the substance. The most relevant 

value for PAC is the 0.02 mg/L as Aluminium. PASA has a lowest NOEC of 75 mg/L. Finally, 

acrylamide monomer has a NOEC of 2.04 mg/L. 

6.1.4 Do the Active Substances and/preparation meet all three criteria for PBT? 

Table 2: Assessment of PBT (MEPC 57/2/3, 8.1.4) 

 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

Triiron 

tetraoxide 

Not applicable No No 

PAC Not applicable No No 

PASA Yes No No 

Acrylamide 

monomers 

No No No 

Therefore, the Group concludes that none of the Active Substances are classified as PBT 

substances. 

7 ASSESSMENT OF TREATED BALLAST WATER 

7.1 The Group noted that The Applicant carried out toxicity tests with saltwater species of 

three trophic levels (algae, invertebrates and fish) with treated ballast water from a land-based 

installation and techniques that simulate the ClearBallast treatment system. Tests were carried 

out with twice as much of the three chemicals (triiron tetraoxide, PAC, and PASA) compared 

usual operation (for more details: IDEA Consultants, Inc., 2007a; 2007b; 2007c and 

MEPC 57/2/2 6.2). 

7.2 The acute toxicity study in algae was conducted according to the International standard 

ISO 10253 and the US EPA. Growth rate of Skeletonema costatum with undiluted and diluted 
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ballast water was tested for this study. As the undiluted water sample showed no reduction of the 

growth rate, the other data (IDEA consultants Inc. 2007a) are not presented here. 

7.3 The chronic toxicity study was carried out with the marine gammarid Hyale barbicornis

with the modified method reported by Anasco et al. and the US-EPA guidelines “Short-term 

Methods for Estimating the Chronic Toxicity of Effluents and Receiving Waters to Marine and 

Estuarine Organisms, Third Edition” (2002). 

7.4 The fish toxicity study was carried out with the saltwater fish Java medaka, Oryzias 

javanicus in accordance with the OECD guidelines No.210 and US-EPA guidelines for 

chronic toxicity. 

Table 3: Summary of acute/chronic toxicity results with treated ballast water 

FCA Species Salinity

[PSU] days

Concentration 

of treated 

water [%] 

NOEC References/ 

Comments 

A 

Skeletonema 

costatum

(acute) 

31.2 3 0 100% 

IDEA 

consultants 

Inc. 2007a 

C 

Hyale 

barbicornis 

(chronic) 

30-30.5 21 100 100% 

IDEA 

consultants 

Inc. 2007b 

F 

Oryzias 

javanicus 

(chronic)

26.9- 

31.8 28 100, 50, 25, 12.5, 6.25 100% 

IDEA 

consultants 

Inc. 2007c 

8 ENVIRONMENTAL RISK ASSESSMENT 

From table 4, the Group concludes that Aluminium-

-ions are very toxic (acute and chronic) to 

aquatic organisms. Therefore, it should be clarified whether or not exposure to Aluminium-ions 

or to PAC occurs after application of the system. 
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Table 4: Derivation of a Predicted No Effect Concentration (PNEC) 

 Lowest Toxicity value 

(mg/L), # of trophic levels 

Assessment 

factor 

PNEC 

(mg/L) 

48-h LC0 (acute), 

1 

> 

1,000 

Triiron 1000 > 1 PNECshort 

tetraoxide 

Chronic data N.A. 

48-h LC50 (acute), 

3 

PAC 840 1000 0.84 PNECshort 

Chronic data N.A. 

96-h LC50 (acute), 

2 

PAC 0.097 1000 0.000097 PNECshort 

(aluminium 

ions) 28-day NOEC 

(chronic), 2 

0.02 100 0.0002 PNEClong 

48-h LC50 (acute), 

2 

PASA 180 1000 0.18 PNECshort 

30-day NOEC 

(chronic), 1 

75 100 0.75 PNEClong 

96-h LC50 (acute), 

3 

Acrylamide 59 1000 0.059 PNECshort 

monomers 

28-day NOEC 

(chronic), 1 

2.04 100 0.02 PNEClong 

8.1.2 Assessment of treated ballast water by ecotoxicity test (G9: 5.3.14) 

A chronic ecotoxicity test was conducted based on GLP principles and in accordance with test 

guidelines established by OECD, ISO, and USEPA to assess the effects of ballast water treated 

by the Hitachi Ballast Purification System on aquatic organisms (for details, see section 6). 

The expected concentrations of each substance are: 

1.38 mg/L triiron tetraoxide, 

0.3 mg/L PAC, 

0.02 mg/L aluminium ions, 

0.032 mg/L PASA, and 

0.001 mg/L acrylamide monomers. 

It should be taken into account that the quantities of chemicals added in the normal operation are 

half of those added in the test. 

From table 21, the Group concludes that treated Ballast discharged water indicate no toxicity to 

any organisms from the three trophic levels tested. However, the group noted that copies of the 

laboratory certificates were not provided. Furthermore, the group recommends that the applicant 

should conduct the additional toxicity testing under higher concentration of PAC and PASA at 

the laboratory scale, e.g. using samples taken before the post filtering. 
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Table 5: NOEC of treated ballast water 

Test substance Classification of 

organism 

Organism 

species End point 

Toxicity 

(Maximum no 

observed effect 

concentration)

Algae 

Skeletonema 

costatum

NOEC for 

72 hrs 

100% treated 

ballast water 

Invertebrates Hyale barbicornis NOEC for 

21 days 

100% treated 

ballast water 

Treated ballast 

water 

Concentrations of 

AS see text 

Fish Oryzias javanicus NOEC for 

40 days 

100% treated 

ballast water 

8.2 Calculation of the Predicted Environmental Concentration (PEC) for the Active 

Substance and Relevant Chemicals

For the discharge calculations, the MAM-PEC model was applied for the prediction of dissolved 

aluminium concentrations in the Port of Rotterdam, assuming all ships operating in the harbour 

use a ClearBallast System (CERI, 2007b). 

In the chemical analysis of the treated ballast water 0.08 mg/L aluminium corresponding to 0.15 

mg/L PAC were found. This represents 1.6% of the originally injected amount of PAC. PASA is 

considered to be discharged in the same ratio as PAC resulting in a discharge concentration 

of 0.016 mg/L. 

Table 6: Summary of predicted discharged concentration PEC 

(MEPC 57/2/3, 8.3.2, table 8-2) 

Predicted concentration at 

discharge (mg/L) 

PEC 

(mg/L) 

Triiron tetraoxide 0.69 <0.69 

PAC 0.15 <0.15 

PAC (aluminium ions) 0.01 <0.00358*

PASA 0.016 <0.016 

Acrylamide monomers 0.00005 <0.00005 

*

 Maximum estimated of environmental concentration based on the MAM-PEC Model. 

The Applicant applies half the detection limit to Aluminium, although elsewhere in the dossier 

Aluminium is reported as having been detected in a concentration of 0.08 mg/L in the treated 

ballast water. 

Applying 0.08 mg/L, the daily load for the Port of Rotterdam would be 31752 g/d and the PEC 

would increase to 0.02864 mg/L. 

It is unclear for the Group, where the concentration of 0.0035 mg/L (Aluminium) comes from, as 

Kobayashi et al. (2006) only refers to Japanese seawater. It is also unclear to the Group, how the 

applicant calculated the PEC value given in the table above and therefore the Group is concerned 

about the use of this number as PEC. 
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The Applicant concluded that Aluminium ions in the ballast water discharged from the Hitachi 

Ballast Water Purification System do not have an influence on the environmental concentration. 

(CERI, 2007b). However, the Group is concerned about accumulation of Aluminium in the 

sediment in the long-term, as shown by the MAM-PEC model. 

8.3 Calculation of PEC/PNEC ratios 

If exposure to Aluminium-

-ions occurs at higher concentrations than established as PNEC in the 

table under 8.1, effects to aquatic organisms can not be excluded. 

Based on the reasoning with regard to the PEC for Aluminium given above, the Group was 

unable to accept the risk assessment as calculated by the applicant. As the PEC’s for PASA, 

triiron tetraoxide and acrylamide monomer refer to the above value, they are also found to be 

unacceptable. The Group therefore recommends to the MEPC to request the applicant to prepare 

a revised risk assessment for consideration in any application for Final Approval. 

As the Active Substances used are not considered to be especially harmful to the marine 

environment in the limited quantities that would be required for further testing of the system on 

land or at sea, the lack of a risk assessment is not considered as a sufficient reason for rejecting 

the application for Basic Approval in this case. 

9 CONCLUSIONS AND RECOMMENDATIONS 

9.1 Risks to the safety of the ship 

The Group notes that risk mitigation measures for the safe storage and handling of the Active 

Substances to be used have been identified. It is to be ensured that the safety measures that have 

been identified are correctly implemented and followed for shipboard installation. 

As there may be a risk to the ship of flooding through the sludge discharge arrangements, should 

equipment malfunction occur, this possibility should receive additional consideration and 

assessment of the actual risk involved prior to shipboard installation. 

The sludge handling, storage and discharge arrangements require an additional assessment of 

safety considerations prior to shipboard trials. 

9.2 Risks to the ship and crew and general public

The Group recommends that for Final Approval the applicant provides additional information 

about frequency and duration of the tasks related to the relevant occupational scenarios 

(please see Figure 2 – Tasks that may pose a human exposure risk). For this purpose the 

Applicant is recommended to refer to MEPC 56, annex 9.

9.3 Risks to the environment

Based on the reasoning with regard to the PEC for Aluminium given above, the Group was 

unable to accept the risk assessment as calculated by the applicant. As the PECs for PASA, 

triiron tetraoxide and acrylamide monomer refer to the above value, they are also found to be 

unacceptable. The Group therefore recommends to the MEPC to request the applicant to prepare 

a revised risk assessment for consideration in any application for Final Approval. 
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As the Active Substances used are not considered to be especially harmful to the marine 

environment in the limited quantities that would be required for further testing of the system on 

land or at sea, the lack of a risk assessment is not considered as a sufficient reason for rejecting 

the application for Basic Approval in this case. 

Therefore, it is recommended by the Group, that an updated risk assessment is added to a 

possible future Final Approval submission, in which for Aluminium a correct approach of the 

background concentration is included. 

9.4 Conclusions

Based on the available information the Group concludes that sufficient information was 

submitted to recommend Basic Approval to Hitachi Ballast Water Purification System – 

ClearBallast. Nevertheless, a considerable amount of additional information is considered 

necessary before any Final Approval could be successful for in the future. A summary of this 

information is given below: 

.1 An adequate quality assurance program needs to be developed for the entire 

system including the quality of PASA at industrial production. 

.2 The human health risks of the system will be evaluated by the GESAMP-BWWG 

on the basis of its individual unit operations, i.e. each component of the system 

requiring operator attention. The manufacturer is therefore requested to describe 

separately the potential human health risks associated with each major component 

of the system and to describe the measures necessary to prevent human exposure. 

In particular, the methods employed for the collection, treatment and disposal of 

floc and their potential for occupational exposure and the recommended risk 

reduction measures need clear explanation and documentation, e.g. any 

procedures such as floc collection, dewatering, drying, incineration, sterilization, 

storage and disposal in whatever form. 

.3 The system is based on standard drinking water purification technology, 

specifically the flocculation of suspended organic matter by iron tetraoxide and 

poly aluminium chloride combined with polyacrylamide. Recovery of the floc is 

achieved by the use of magnetic disks which attract the iron component of the 

floc, presumably allowing quicker separation. An attractive aspect of the system 

is that it uses no biocides and where the environment is concerned, the chemicals 

employed are relatively harmless. 

.4 The active substances are well known and have a large literature in terms of 

human and environmental health; the WHO Guidelines on the treatment of 

drinking water provide good background information. 

.5 The storage and handling of the three active substances on board needs to be 

carefully controlled and the proposed safety measures adequately documented, 

particularly bearing in mind the corrosive properties of poly aluminium chloride. 

.6 One major human health issue with the active substances relates to the residual 

acrylamide monomer contained in the polyacrylamide, which has a range of 

associated human health hazards and which, in parallel to best practices in 

drinking water purification, needs to be maintained at appropriately low 
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concentrations. The quality of the polyacrylamide active substance needs to be 

strictly controlled and included in the QA program. 

.7 The BWM system appears from the technical description to be partly open, 

allowing for possible occupational exposure to the crew to system processes and 

waste. This is a potential weakness of the system that remains to be adequately 

addressed. 

.8 Human health issues related to the potential concentration of pathogens in the 

flocs need to be examined and assessed in detail. The flocs could under heavily 

polluted intake conditions, have the potential to form a biohazard. 

.9 Adequate separation of the flocs from the treated water is crucial to the successful 

operation for the system. When scaling up to larger treatment capacities, this 

aspect must be addressed by the applicant, to ensure the human and environmental 

risks of the treated ballast water remains acceptable. 

.10 The positioning and operation of the proposed pre-filtration, post filtration and its 

related post filtration residue feedback system must be better described and 

documented. The procedures and processes for routine system maintenance, 

emergency procedures, filter and sludge conveyor cleaning, and the treatment and 

handling of the sludge must be defined and detailed. 

.11 The risk to the marine environment from the residual active substances must be 

assessed. Concentrations of heavy metals, aluminium, iron, acrylamide monomer, 

VOCs, and faecal coliforms must be measured in the intake water, collected 

sludge and the discharged ballast water from the representative ballast waters 

associated with testing under G8. The environmental risks of discharging 

polyacrylamide, a non-biodegradable polymer to shore and any subsequent 

disposal restrictions must be assessed. 

.12 Disposal of the collected sludge to shore waste reception facilities is to be 

according to the relevant IMO regulations. The availability of suitable harbour 

reception facilities needs to be considered. 

.13 The risk assessment carried out by the applicant in the submission can not be 

accepted by the GESAMP-BWWG as it is unclear how the risk assessment was 

performed and how the both PEC and PNEC concentration of Aluminium-ions 

and other active substances and relevant have been established. 

.14 Additional toxicity testing of the treated Ballast Water should be performed using 

more residual substances. 

.15 The maximum allowance discharge concentration should be set against the 

parameters that can be measured at such low level. According to the applicant, it 

is difficult to measure the amount of PASA directly, if its concentration in water 

is low. This situation is considered to be unsatisfactory by the Group and an 

acceptable analytical method should be developed for confirming the maximum 

allowance discharge concentration for adequate parameters. 

* * * 
GESAMP-BWWG 4/9 

ANNEX 5 

Page 16 

I:\MEPC\57\2.doc 

APPENDIX 1 

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF TRIIRON 

TETRAOXIDE, PAC, PASA AND ACRYLAMIDE MONOMERS 

1 PHYSICOCHEMICAL PROPERTIES 

1.1 The following table shows the physicochemical properties of triiron tetraoxide, PAC, 

PASA, acrylamide monomers, and treated ballast water. 

Only conductivity data were extracted from the extended version of the Application Dossier. 

Table 1: Physicochemical properties of Active Substances and Relevant Chemicals 

Triiron 

tetraoxide PAC PASA Acrylamide 

monomers 

Treated 

ballast water

CAS No. 1317-61-9 1327-41-9 25085-02-3 79-06-1 None 

Melting point (°C) 1,538 1) About -12 2) Not 

Applicable 

84.5 1) NR9)

Boiling point (°C) Not 

Applicable 

About 103 2) Not Applicable 125 at 3kPa 1) NR 

Flammability (Flash point 

for liquids ; °C) 

Not 

Applicable 

Noncombustible5) None#1, 4) 138 (closed 

method) 3)

NR 

Density (20°C; kg/m3) 5,200 

(5.2g/cm3

) 1)

1,340 (1.34g/cm3

) 

2)

Bulk specific 

gravity; 0.55-

0.65 4)

1,130(1.13g/cm3

) 

3)

NR 

Vapour pressure (20°C; 

Pa) 

Not 

Applicable 

Non-evaporable 5) Non-evaporable #2

1 3) NR 

Vapour density (air = 1) Not 

Applicable 

Not Applicable Not Applicable 2.46 (calculated 

value) 

NR 

Water solubility 

g/L 

Insoluble 6) Soluble1) Mixing with 

water forms 

highly viscous 

gel-like 

material 4)

2,040 (25°C) NR 

Oxidationreduction potential Not 

Applicable 

None 5) None 4) None 7) None 

Corrosivity to 

materiaequipment 

None Corrosive to 

metals 

None None None 

Autoignition temperature 

(°C) 

Not 

Applicable 

Noncombustible5) None 4) 424 3) NR 

Explosive properties Not 

Applicable 

None None None 7) NR 

Oxidizing properties Not 

Applicable 

None 5) None 4) None 7) NR 

Surface tension None Equal to water 

because of aqueous 

solution 

None None NR 

Viscosity 

(mPa.s) 

None 28mPa・s (25°C) 2) Mixing with 

water forms 

highly viscous 

gel-like 

material 4)

2.71 mPa・s (25°C) 

(50% aqueous 

solution) 8)

1.55cP 

(16°C) 

Thermal stability Transformed 

into iron 

oxide 

(Fe2O3) by 

Non flammable Combustible by 

heating at high 

temperature 

Violently 

polymerizes when 

heated to over 

85°C or when 

NR 
GESAMP-BWWG 4/9 

ANNEX 5 

Page 17 

I:\MEPC\57\2.doc 

Triiron 

tetraoxide PAC PASA Acrylamide monomers 

Treated 

ballast water

heating in 

air1)

exposed to of light 

or oxidizing 

agents. 

When heated to 

decomposition, 

fumes and nitrogen 

oxide are 

generated. 3), 8)

Reactivity to container 

material 

None None None None NR 

pH in solution NR NR 4.3 (15%) 1) NR NR 7 - 7.3 

Salinity N.D. 

Conductivity 4.5 S/m 

TOC 1.3 mg/L 

DOC N.D. 

Other physicochemical properties None None None Because acrylamide 

readily 

polymerizes, 

common products 

contain 

polymerization 

inhibitors1)

None 

Dissociation constant 

(pKa) 

Not 

Applicable 

No dissociable 

group 

No dissociable 

group 

No dissociable 

group 

NR 

 1) Merck, 2006, 2) EU, 2000b, 3) IPCS, 2000, 4) Dia-Nitrix, 2004, 5) Asada Chemical Industry, 

 2003, 6) Dean,1999, 7) EU, 2002, 8) HSDB, 2007, 9) NR: not required for G9 

 #1 Non-combustible under conditions of normal use (normal pressure, 0-50°C). 

 #2 Non-evaporable under normal pressure and normal temperature because of high molecular weight polymers 

(several million or more). 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data (Ref. MEPC 56/2/3, 3.1.1) 

2.1.1 There are no triiron tetraoxide acute toxicity data for algae and invertebrates. Considering 

that naturally-occurring triiron tetraoxide is abundant in the environment and is not absorbed or 

accumulated in the body due to consisting of water insoluble particles, the toxicity of triiron 

tetraoxide for algae and invertebrates is considered to be very low. 

2.1.2 No data on the PASA acute toxicity in algae are reported. As PASA consists of particles 

containing high molecular weight polymers (several millions or more), it is not absorbed and 

accumulated in the body. The toxicity of PASA in algae is considered to be low, not including 

any physical harmful effect. 
GESAMP-BWWG 4/9 

ANNEX 5 

Page 18 

I:\MEPC\57\2.doc 

2.1.3 A summary of the acute aquatic toxicity data for Triiron tetraoxide, PAC, PASA and 

Acrylamide monomers is shown in the table below: 

FCA Species Effect Conc. 

[mg/L] Reference

Triiron 

tetraoxide F Leuciscus idus 

(Japanese dace) 48 h LC0 > 1,000 EU, 2000a 

PAC A Seaweed 48 h 

LC50growth 

1,500 

(pH not 

adjusted) 

>10,000 

(pH adjusted) 

Asada Chemical 

Ind. 2003 

 Manila clams 48 h LC50

6800 

(pH not 

adjusted) 

>10,000 

(pH adjusted) 

Asada Chemical 

Ind. 2003 

F Oryzias latipes 48 h LC50

840 

(pH not 

adjusted) 

>10,000 

(pH adjusted) 

Asada Chemical 

Ind. 2003 

PAC as 

aluminiumion 

I 

Ctenodrilus 

serratus (marine 

sand worm)

96 h LC50 0.097 

IPCS, 1997; 

Petrich and Reish, 

1979 

F Pimephales 

promelas 96 h LC50

4.25 (pH 6.5-

7.5) IPCS, 1997 

PASA C 

Ceriodaphnia 

dubia 

(Freshwater)

48 h LC50 218 De Rosemond and 

Liber, 2004 

F Girella punctata 48 h LC50 840 Tabata and 

Ishibashi, 1984 

F 

Oryzias latipes, 

Carassius 

auratus, Cyprinus 

carpio, Salvelinus 

namaycush, 

48-h LC50

48-h LC50 

48-h LC50 

96-h LC50 

180 

350 

 and >600 mg/L 

250 

>600 

Tabata and 

Ishibashi, 1984 

Dia-Nitrix, 2004; 

Liver et al., 2005; 

Tabata and 

Ishibashi, 1984 

Acrylamide 

monomers A 

Pseudokirchneriella subcapitata 

(Freshwater) 

72 h 

EC50Growth

33.8 EU, 2002 

Acrylamide 

monomer 

C Mysidopsis bahia 96 h LC50 78 EU, 2002 

Acrylamide 

monomer 

F Daphnia magna 48 h EC50 98 EU, 2002 

Acrylamide 

monomer 

F Danio rerio 96 h LC50 59 Kovriznych and 

Urbancikova, 2001 
GESAMP-BWWG 4/9 

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Page 19 

I:\MEPC\57\2.doc 

2.2 Chronic Aquatic Toxicity Data 

2.2.1 There are no chronic toxicity data available for triiron tetraoxide and PAC in aquatic 

organisms. Naturally occurring triiron tetraoxide is abundant in the environment. Although it is 

highly possible that wild organisms are exposed to this substance, no adverse effects have been 

identified. Therefore, it may be concluded that chronic toxicity of triiron tetraoxide is not 

significant. 

2.2.2 To evaluate the toxicity of PAC in aquatic organisms, data on water soluble aluminium 

salts such as aluminium chloride can be examined because the salts are dissociated in water and 

form the same aqua complex as PAC. Data on the chronic toxicity of acrylamide monomers were 

gathered because traces of unpolymerized acrylamide monomers remain in PASA as an impurity. 

2.2.3 A summary of the chronic aquatic toxicity data for aluminium ions, PASA and 

acrylamide monomers is shown in the table below: 

FCA Species Effect Conc. 

[mg/L] Reference

Aluminiumions 

Ctenodrilus 

serratus 

(polychaete) 

28 d 

NOEC 

0.02 

pH: 7.6 - 8.0 

Petrich and Reish, 

1979 not cited 

Aluminiumions F 

Salvelinus 

fontinalis 

(Freshwater) 

60 d 

NOEC 

0.088 

pH: 6.5 - 6.6 

Asada Chemical 

Ind. 2003 

PASA F 

Salvelinus 

namaycush 

(Freshwater)

30 d 

NOEC 

75 (activity) 

300 (growth 

+survival) 

Liver et al., 2005 

Acrylamide 

monomers A 

Pseudokirchneriella 

subcapitata 

(Freshwater) 

72 h 

NOEC 16 (growth) EU, 2002 

Acrylamide 

monomer 

C Mysidopsis bahia 28 d 

NOEC 2.04 Springborn Bionomics, 1985 

2.3 Information on Endocrine Disruption 

There are no data submitted or other reports made available on triiron tetraoxide, PAC, PASA, 

and acrylamide monomers having an effect on endocrine disruption in aquatic organisms. 

None of these substances are listed as suspected endocrine disruptors (MOE, 2005). The Group 

concludes that no additional data are required on the potential endocrine disrupting effects of the 

substances under consideration for this Ballast Water System under G9. 

2.4 Sediment Toxicity 

2.4.1 There are no reports of sediment toxicity of triiron tetraoxide, PAC, or PASA. 

2.4.2 Triiron tetraoxide and PAC are inorganic compounds, which occur as triiron tetraoxide or 

aqua-complex ions of aluminium in the sediment. As these substances are naturally occurring 

elements, the probability of these substances having an adverse effect on the sediment organisms 

is considered to be low. 
GESAMP-BWWG 4/9 

ANNEX 5 

Page 20 

I:\MEPC\57\2.doc 

2.4.3 Although PASA is accumulated in the sediment, it is not absorbed or accumulated in the 

sediment organisms because it consists of particles of high molecular weight polymers 

(several million or more). Therefore, the possibility of PASA having an adverse effect on 

sediment organisms is considered to be low. 

2.4.4 Acrylamide monomers (PASA impurity) are biodegraded and mineralized easily. 

The possibility of acrylamide monomers being accumulated in the sediment and the possibility of 

adverse effects on sediment organisms is low due to the high water solubility, and low KOW

and KOC. 

Water solubility is 2040 g/L (IPCS, 2000) 

log KOW -1.65 to -0.67 and KOC 0.195 L/kg, (EU, 2002). 

Therefore, Acrylamide monomers are not absorbed or accumulated in the sediment and the 

possibility of adverse effects on sediment organisms is very low. 

2.5 Bioavailability/Biomagnification/Bioconcentration 

2.5.1 Instead of PAC, data on water-soluble aluminium salts were examined to evaluate the 

bioconcentration factors. 

2.5.2 No reports on the bioconcentration of triiron tetraoxide were found. However, because it 

consists of water insoluble particles, triiron tetraoxide is not absorbed or accumulated in living 

organisms and has no bioaccumulation. 

2.5.3 A summary of the chronic aquatic toxicity data for aluminium ions, PASA and 

acrylamide monomers is shown in the table below: 

FCA Species BCF Comments Reference

Aluminium 

chloride F 

Salvelinus 

fontinalis 

(Freshwater) 

36 

200 μg Al/L, 56 d 

pH 7.2; 1% 

mortality 

Cleveland et al., 

1991 

Unspecified Al 

salt F Salmo salar 76-190 60 d, pH 5.5 

33-264 μg/L 

Buckler et al., 

1995 

PASAAnionic 

polyacrylamide 

F Cyprinus 

carpio 

0.23-

0.32 

0.33-

0.35 

0.26-

0.41 

0.1 mg/L 

2 weeks breeding 

4 weeks breeding 

6 weeks breeding 

OEC, 2003 

Acrylamide 

monomer 

F Cyprinus 

carpio 

0.26 

0.77 

1 mg/L, 20 d 

10 mg/L, 20 d EU, 2002 

Acrylamide 

monomer 

F Oryzias latipes 0.31 

2.53 

1 mg/L, 20 d 

10 mg/L, 20 d EU, 2002 

Acrylamide 

monomer 

F Oncorhynchus 

mykiss 1.44 

1.65 

0.71 mg/L, 72 h 

Whole body 

Internal organs 

EU, 2002 
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I:\MEPC\57\2.doc 

3 MAMMALIAN TOXICITY 

3.1 Acute mammalian Toxicity 

3.1.1 Triiron tetraoxide, PAC and PASA are considered to have low acute toxicity by the oral 

route. No data were submitted for dermal and inhalation routes therefore they cannot be fully 

evaluated and MSDS were of poor quality. Acrylamide monomer is toxic if swallowed 

(GHS classification, Annex VI, COM (2007) 355 final), and also harmful if inhaled or in contact 

with skin. 

3.1.2 A summary of the mammalian toxicity data for triiron tetraoxide, PAC, PASA and 

acrylamide monomers is shown in the table below: 

Exposure 

path Animal 

species 

End 

point 

Value 

mg/kg 

bodyweight 

Reference 

Triiron 

tetraoxide

Oral Rats LD50 >10,000 EU, 2000a 

PAC Oral Mice LD50 Ca. 7,000 EU, 2000b 

 Rats LD50 >2,000 EU, 2000b 

PASA Oral Rats LD50 >4,000 Cosmetic Ingredient 

Review, 2005 

Acrylamide 

monomers

Oral Mice, rats, 

rabbits, and 

guinea pigs 

LD50 150 - 180 ACGIH, 2001a 

Acrylamide 

monomers

Oral Mice and rats LD50 107 - 203 EU, 2002 

Acrylamide 

monomers

Percutaneous Rabbits LD50 Ca. 1,150 EU, 2002 

3.2 Corrosion/Irritation 

3.2.2 Effect on skin 

3.2.2.1 PAC is irritating to skin (self classification by supplier) and acrylamide monomer is 

also irritating to skin (GHS classification, Annex VI, COM (2007) 355 final). 

3.2.2.2 A summary of the effects on skin irritation for triiron tetraoxide, PAC, PASA and 

acrylamide monomers is shown in the table below: 

Substance Species Methods Result Reference/ 

Comments

Triiron 

tetraoxide Rabbits OECDTG404 Not irritating EU, 2000a 

PAC Rabbits OECDTG404 Not irritating EU, 2000b 

PAC 

Rabbits, 

mice, and 

pigs 

Not specified Not irritating EU, 2000b 

PAC Humans Not specified irritating EU, 2000b 

PASA Rabbits Not specified Not irritating Cosmetic Ingredient 

Review, 2005 
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ANNEX 5 

Page 22 

I:\MEPC\57\2.doc 

Acrylamide 

monomers Rabbits Not specified 

No: for uninjured skin 

Very mild erythema and 

edema: for injured skin 

ACGIH, 2001a 

Acrylamide 

monomers Rabbits Not specified irritating EU, 2002 

Acrylamide 

monomers 

Humans Occupational 

exposure 

Dermal irritation, skin 

separation EU, 2002 

3.2.3 Effects on eye 

3.2.3.1 PAC is irritating to eyes (self classification by supplier) and acrylamide monomer is 

also irritating to eyes, causing serious eye irritation (GHS classification, Annex VI, 

COM (2007) 355 final). 

 

3.2.3.2 A summary of the Effects on eyes for triiron tetraoxide, PAC, PASA and acrylamide 

monomers is shown in the table below: 

Substance Species Method 

Guidelines Result Reference/ Comments

Triiron 

tetraoxide No data No data No data EU, 2000a 

PAC Rabbits OECDTG404 Mild EU, 2000b 

PAC Humans Not specified irritation EU, 2000b 

PASA Rabbits Not specified Solid: Mild 

5% water solution: No 

Cosmetic Ingredient 

Review, 2005 

Acrylamide 

monomers Rabbits Not specified 

10% water solution: 

Mild 

40% water solution: 

irritating 

ACGIH, 2001a 

Acrylamide 

monomers Rabbits Not specified irritating EU, 2002 

3.1 Sensitization 

3.1.1 Acrylamide is a skin sensitiser (GHS classification, Annex VI, COM (2007) 355 final). 

3.1.2 A summary of the effects on sensitization for triiron tetraoxide, PAC, PASA and 

acrylamide monomers is shown in the table below: 

Substance Species Method 

Guidelines

Sensitizer 

(yes/no)

Reference/ 

Comments

Triiron 

tetraoxide Guinea pigs Not specified Not sensitising EU, 2000a 

PAC Rabbits Not specified Not sensitising EU, 2000b 

PASA No data No data 

Not expected 

to be a 

sensitizer 

Cosmetic Ingredient Review, 

2005 

Acrylamide 

monomers Guinea pigs Not specified Sensitizer EU, 2002 
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I:\MEPC\57\2.doc 

3.4 Repeated-Dose Toxicity 

3.4.1 Triiron tetraoxide 

3.4.1.1 There is a report on intravenous (iv) administration in rats over three weeks and 

intravenous (iv) administration in dogs over three weeks, which shows that pigment deposition 

increases in cells of the reticuloendothelial system but no injury in tissues occurs (EU, 2000a). 

Triiron tetraoxide is expected to have no adverse effects with repeated dose toxicity 

(subacute/subchronic toxicity) because it consists of insoluble inorganic microparticles which are 

not absorbed in the body. 

3.4.2 PAC 

3.4.2.1 In an inhalation exposure test of 22 days in which PAC solutions of 0.34 μg/L 

and 2.5 μg/L were given to rats 4 hours a day at a frequency of 5 days a week, no toxicity or 

accumulation in tissues were observed (EU, 2000b). 

3.4.3 PASA 

3.4.3.1 No chronic toxicity was observed in a test in which feedstuffs containing 500 

to 50,000 ppm of polyacrylamide were given to rats and dogs (Cosmetic Ingredient 

Review, 2005). PASA is expected to have no adverse effects with repeated dose toxicity 

(subacute/subchronic toxicity) because it consists of high molecular weight polymer particles 

(several million or more) which are not absorbed in the body. 

3.4.4 Acrylamide monomers 

According to several tests by per oral administration to laboratory animals, the major toxic 

effects are on the nervous system and male generative organs. Acrylamide is classified 

according to its properties to cause damage to organs through prolonged or repeated contact 

(GHS classification, Annex VI, COM (2007) 355 final). A summary of the effects on repeated 

dose toxicity for acrylamide monomers is shown in the table below: 

Species days Dose Effects Reference/ 

Comments

Rats 90 d 3-400 mg/kg 

feed 

Neurotoxicity above 300 mg/kg, 

seminiferous epithelium 

degeneration at 400 mg/kg, 

NOAEL 110 mg/kg (5.5 mg/kg 

bodyweight day) 

ACGIH, 2001a 

Rats 90 d 0.05-20 mg/kg 

bodyweight day 

Neurotoxicity above 1mg/kg/bw 

Severe degeneration of peripheral 

nerves at 20mg/kg/bw 

NOAEL 0.2mg/kg/bw 

ACGIH, 2001a 

Humans N.D. N.D. 

adverse effects on the central 

nerve system, loss of muscle 

strength, disturbance of muscle 

co-ordination, gait abnormality, 

tremor, and hallucination 

ACGIH, 2001a 
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I:\MEPC\57\2.doc 

3.5 Chronic toxicity 

3.5.1 Triiron tetraoxide (Ref. MEPC 57/2/2, 5.3.5) 

No data on chronic toxicity for laboratory animals are available. However, inhalation of iron 

oxide dust or fume during occupational exposure can cause a benign pneumoconiosis 

(ACGIH, 2001b). 

3.5.2 PAC (Ref. MEPC 57/2/2, 5.3.5) 

3.5.2.1 In several reports on inhalation exposure using laboratory animals, the accumulation of 

aluminium in the lungs, lymph nodes around the lung alveoli, and adrenal glands, and lung 

disorders are reported. In tests in which rats and guinea pigs were exposed to three levels of PAC 

content, 0.25, 2.5, and 25 mg/m3

 for 6 hours a day at a frequency of five days a week for 

six months, the value of the: 

3.5.2.2 NOAEL could not be obtained, LOAEL was 0.25 mg/m3

 (EU, 2000b), with lung injury 

occurring at a PAC concentration of 0.25 mg/m3 or more, increase in weight was suppressed at a 

concentration of 25 mg/m3

. 

3.5.2.3 PAC is widely used in the municipal purification of water, and no adverse effects to 

human health have been identified (AWWA, 2004). 

3.5.3 PASA (Ref. MEPC 57/2/2, 5.3.5) 

Several tests have been conducted in which feedstuffs containing 500 to 100,000 mg/kg of 

polyacrylamide were given to rats for two years. No toxic effects or pathological changes related 

to the administration were observed in any of the tests (Cosmetic Ingredient Review, 2005). 

Regarding chronic toxicity in humans, no adverse effects have been observed on workers 

exposed to dust containing polyacrylamide (1 mg/m3

) over five years or more in polyacrylamide 

manufacturing plants (Cosmetic Ingredient Review, 2005). 

3.5 Development and Reproductive Toxicity

3.5.1 Triiron tetraoxide (Ref. MEPC 57/2/2, 5.3.6) 

3.5.1.1 There are no data available on the reproductive and developmental toxicity of triiron 

tetraoxide. 

3.5.2 PAC (Ref. MEPC 57/2/2, 5.3.6) 

3.5.2.1 The reference used by the applicant (EU, 2000b; U.S., NIOSH, RTECS, 2007) is 

considered not valid by the Group to assess the reproductive/developmental toxicity. 

3.5.3 PASA (Ref. MEPC 57/2/2, 5.3.6) 

3.5.3.1 No effects on reproduction were observed in a three-generation test in which 

feedstuffs containing two levels of polyacrylamide, 500 and 2,000 , were given to rats 

(Cosmetic Ingredient Review, 2005). 
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Page 25 

I:\MEPC\57\2.doc 

3.5.4 Acrylamide monomers (Ref. MEPC 57/2/2, 5.3.6) 

3.5.4.1 There are several reports of reproductive toxicity in per oral administration to 

laboratory animals, and it has been shown that male genital toxicity and male sterility are caused. 

The value of the NOAEL with the effect on fertility potential was 5 mg/kg/day as for rats, and 

was 9 mg/kg/day as for mice (EU, 2002). Acrylamide is suspected to damage fertility 

(GHS classification, Annex VI, COM (2007) 355 final). 

3.6 Carcinogenicity/Mutagenicity/Reprotoxicity 

3.6.1 Carcinogenicity 

3.6.1.1 Acrylamide is classified according to its carcinogenic properties (may cause cancer) 

(GHS classification, Annex VI, COM (2007) 355 final). 

3.6.1.2 A summary of the Carcinogenicity data for triiron tetraoxide, PAC, PASA and 

acrylamide monomers is shown in the table below: 

AS Species Effects Reference/ 

Comments

Triiron 

tetraoxide 

IARC (Intern. Agency Res. Cancer) 

Group 3 (not classifiable as to 

carcinogenicity to humans), 

CAS 1309-37-1 (ferric oxide) 

 (IARC, 1987) 

PAC as 

aluminium 

potassium 

sulfate 

Insufficient information available to 

assess this endpoint MEPC 57/2/2, 5.3.8 

PASA as 

polyacrylamide 

Rats 500 to 100,000 mg/kg in food, 2 years: 

no lesions observed 

Cosmetic Ingredient 

Review, 2005 

PASA as 

polyacrylamide 

Dogs 500 to 50,000 ppm in food, 2 years: 

no lesions observed 

Cosmetic Ingredient 

Review, 2005 

Acrylamide 

monomers 

Rats 

Dosage via drinking water 

Increase in the incidence ratio of 

tumors; relationship with endocrine 

disruption and genotoxicity is 

suggested 

EU, 2002 

Acrylamide 

monomers 

Humans IARC Group 2A (probably 

carcinogenic to humans) IARC, 1994 

3.6.2 Mutagenicity/genotoxicity 

3.6.2.1 Acrylamide is classified according to its mutagenic properties (may cause genetic 

defects) (GHS classification, Annex VI, COM (2007) 355 final). 
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ANNEX 5 

Page 26 

I:\MEPC\57\2.doc 

3.6.2.2 A summary of the mutagenicity/genotoxicity data for triiron tetraoxide, PAC, PASA 

and acrylamide monomers is shown in the table below: 

AS Species Effects Reference/ 

Comments

Triiron 

tetraoxide 

Salmonella 

typhimurium 

in vitro 

(Ames test) 

Negative EU, 2000a 

PAC as 

aluminium 

Sulphate 

Salmonella 

typhimurium

in vitro 

(Ames test)

Negative IPCS, 1997 

(Not submitted) 

PAC as 

aluminium 

sulfate 

Mouse Negative on gene mutation 

(L5178Y cells of lymphoma) IPCS, 1997 

(Not submitted) 

PAC as 

aluminium 

Sulphate 

Human 

leucocytes 

Positive in chromosomal aberration 

test 

IPCS, 1997 

(Not submitted) 

PAC as 

aluminium 

chloride 

Mice 

In vivo 

(intraperitone

al) 

Positive 

(induction of chromosomal 

aberrations in marrow cells) 

IPCS, 1997 

(Not submitted) 

PAC as 

aluminium 

sulphate 

Rats 

In vivo 

(intraperitone

al) 

Positive 

(induction of chromosomal 

aberrations in marrow cells) 

IPCS, 1997 

(Not submitted) 

PASA No data available in the submission MEPC 57/2/2, 5.3.7 

Acrylamide 

monomers 

Bacteria 

in vitro Negative MEPC 57/2/2, 5.3.7 

Acrylamide 

monomers 

Animal cells 

In vitro 

Positive 

micronucleus test, unscheduled 

DNA synthesis (UDS) test, and sister 

chromatid exchange (SCE) test 

MEPC 57/2/2, 5.3.7 

Acrylamide 

monomers 

Somatic cells 

In vivo Mutagenic in vivo (see text below) EU, 2002 

Acrylamide 

monomers 

Germ cells 

In vivo Mutagenic in vivo (see text below) EU, 2002 

3.6.2.2 Acrylamide monomers are clearly mutagenic in vivo in somatic cells, producing 

positive results particularly in the bone marrow micronucleus assay. The pattern of results 

indicated clastogenicity or interference with mitosis rather than gene mutation activity 

(EU, 2002). 

3.6.2.3 Clearly positive in vivo in a number of different germ cell assays (chromosome 

aberrations, micronucleus assay, UDS, dominant lethal assays, heritable translocation, and 

specific locus assays) indicating that it is a germ cell mutagen (EU, 2002). 

3.6.2.4 It has been suggested that the possible mechanism for genotoxic effects of acrylamide 

in mammalian systems is by acrylamide neurotoxicity occuring in both central and peripherical 

nervous system likely through microtubule disruption (CIR, 2005). 
GESAMP-BWWG 4/9 

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I:\MEPC\57\2.doc 

3.7 Toxicokinetics 

3.7.1 A summary of the toxicokinetics data for triiron tetraoxide, PAC, PASA and acrylamide 

monomers is shown in the table below:

AS Method Effects Reference/ 

Comments

Triiron 

tetraoxide 

Rats 

2h inhalation Clearance half-life was 47 d (EU, 2000a,) 

Triiron 

tetraoxide Human 

Evidence from several surveys with 

occupational exposure suggest that 

there is accumulation of dust iron 

oxide in the lungs 

ACGIH, 2001b 

PAC Rats 

24 months inhalation 

accumulation of aluminium in the 

lungs, secondary to adrenal glands 

EU, 2000b 

PAC Guinea pigs 

21 months inhalation. 

accumulation of aluminium in the 

lungs, secondary to lymph nodes 

EU, 2000b 

PASA Rats 

Per oral administration: acrylamide 

was found in faeces and bowel 

contents, but not in body tissues. 

Cosmetic Ingredient 

Review, 2005 

Acrylamide 

monomers 

Rats and 

mice 

Oral and percutaneous absorption, 

Excretion with urine or exhalation as 

CO2 in breath, only small proportion 

is excreted with faeces. 

EU, 2002 

Acrylamide 

monomers 

Rats selective accumulation in nerve cells 

was not observed ACGIH, 2001a 

3.7.2 Acrylamide monomers showed to be rapidly absorbed orally and percutaneously by 

different species so that unchanged substances and metabolites are widely distributed in living 

organisms. In particular, they are distributed to the male reproductive organs and to unborn 

babies through the placenta. There are only limited data on the in vivo fate of acrylamide 

monomers in humans, and it has been indicated that acrylamide is absorbed orally or 

percutaneously because acrylamide monomer adducts are detected in hemoglobin (EU, 2002). 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS 

4.1 Modes of degradation (biotic and abiotic) 

4.1.1 Hydrolysis (Ref. MEPC 57/2/2, 5.4.1.1) 

4.1.1.1 Hydrolysis properties do not apply to triiron tetraoxide and PAC because they are 

inorganic compounds. Since the half-life period of acrylamide monomers for hydrolysis is more 

than one year under the conditions of pH 5 to 9 and 55°C, acrylamide monomers are considered 

not to be easily hydrolyzed in environmental water (EU, 2002). Therefore, it is assumed that 

PASA is resistant to hydrolysis, as in the case of acrylamide in environmental water. 
GESAMP-BWWG 4/9 

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4.1.2 Biodegradability (biotic/abiotic) (Ref. MEPC 57/2/2, 5.4.1.2) 

4.1.2.1 Biodegradability does not apply to triiron tetraoxide or PAC because they are 

inorganic compounds. Regarding the biodegradability of PASA, there is a report on the 

degradation rate of activated sludge taken from an urban sewage treatment plant using the 

coulometer method, in which PASA was assessed to be non-biodegradable because it was hardly 

degraded after 300 hours (OEC, 2003). The group considers PASA as fairly undegradable as its 

degradation does not take place in several years (Khaitan et al., 2003) 2. 

4.1.2.2 The biodegradability of acrylamide monomers has been tested based on 

OECD TG301D. Since the biochemical oxygen demand (BOD) values for 28 days under the two 

levels of the concentration of testing substance, 2 mg/L and 5 mg/L, were 100 and 53.3%, 

respectively, it has been determined that acrylamide monomers are easily degraded at lower 

concentrations (<2 mg/L) (EU, 2002). 

4.1.2.3 A summary of the modes of degradation data for acrylamide monomers is shown in the 

table below:

Substance Method Degradability 

(Yes/No) 

Half-Life 

life period

Degradation rate References/ 

Comments

Acrylamide 

monomers 

OECD 301D 

Closed bottle 

BOD 

2 mg/L 

5 mg/L 

Yes <2 mg/L 

No 5 mg/L 

BOD 

2 mg/L: 

100% 

2 mg/L: 

53.3% 

EU, 2002 

Acrylamide 

monomers 

Aerobic 

degradability 

test with 

freshwater 

microorganisms 

acclimated for 

33-55 h 

Yes 55-70 h IPCS, 1985

Acrylamide 

monomers 

Aerobic 

degradability in 

different soils 

Yes 

18-45 h 

(25 mg/kg) 

95 h 

(500 

mg/kg) 

 EU, 2002 

4.2 Partition Coefficients

4.2.1 A partition coefficient is not applicable to triiron tetraoxide or PAC because they are 

inorganic compounds. Further, a partition coefficient is not applicable to PASA because it is a 

high molecular weight polymer compound. 

4.2.2 The octanol/water partition coefficient (log POW) for acrylamide monomer is -0.67 

to -1.65, and soil adsorption coefficient, KOC, is 0.195 L/kg (EU, 2002). 
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4.3 Persistence and Identification of Main Metabolites

No generation of degradation products occurs from any of triiron tetraoxide, PAC, and PASA. 

Since acrylamide monomers are resistant to hydrolysis and easily biodegraded and mineralized 

under aerobic conditions, degradation products are not generated. 

4.4 Reaction with Organic Matter 

Triiron tetraoxide, PAC, PASA, and acrylamide monomers all do not generate free radicals, and 

do not react with organic compounds. 

4.5 Potential Physical Effects on Wildlife and Benthic Habitats 

Triiron tetraoxice, PAC, PASA, acrylamide monomers, and flocs would have no physical effect 

on the habitat of fish species, avian species, marine mammals or benthic organisms. 

4.6 Potential Residues in Seafood 

The substances used in this system do not exhibit bioconcentration and so exhibit no potential 

persistence in seafood. 

4.7 Any Known Interactive Effects 

5 OTHER INFORMATION

5.1 Analytical Methods for Measuring the Concentration at environmentally Relevant 

Concentrations 

5.1.1 Triiron tetraoxide (Ref. MEPC 57/2/2, 5.6) 

The sample water is analysed by ICP emission spectroscopic analysis (ICP-AES) and detected as 

iron ions. 

5.1.2 PAC 

The sample water is analysed by ICP emission spectroscopic analysis (ICP-AES) and detected as 

aluminium ions. 

5.1.3 PASA 

According to the applicant, it is difficult to measure the amount of PASA directly, if its 

concentration in water is low. This situation is considered to be unsatisfactory by the Group and 

an acceptable analytical method should be developed. 

5.1.4 Acrylamide monomers 

Acrylamide monomers in the sample water are brominated using potassium bromide solution and 

potassium bromate solution under acidic conditions to obtain dibromo-derivatives. Excess 

bromine is reduced and eliminated with sodium thiosulfate, and the dibromo-derivatives are then 

extracted with ethyl acetate. Triethylamine is added to the solution to remove hydrogen bromide, 

and the obtained monobromo-derivatives are analysed by gas chromatography (GC). 
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5.2 Material Safety Data Sheet provided: Yes 

5.3 GHS Classification .................................... 

5.4 Risk Characterization 

 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

Triiron 

tetraoxide 

Not applicable No No 

PAC Not applicable No No 

PASA Yes No No 

Acrylamide 

monomers 

No No No 

Therefore, the Group concludes that none of the Active Substances is classified as 

PBT substances. 

*** 
GESAMP-BWWG 4/9 

I:\MEPC\57\2.doc 

ANNEX 6

REVIEW OF PROPOSAL FOR THE APPROVAL OF ACTIVE SUBSTANCES 

CleanBallast! using the basic approved EctoSys® technology 

Submitted for Final Approval by Germany as MEPC 57/2/3 

0 SUMMARY 

0.1 Final Approval of the CleanBallast! System the Ectosys® technology is not

recommended to be granted based on the submission provided by Germany.

0.2 The Group noted that the proposed system treats the ballast water both on uptake and at 

discharge. The use of a secondary treatment at discharge is to address any potential for 

re-growth of organisms in the ballast tank. At uptake the ballast water is filtered and then treated 

by electrolysis directly in the ballast water pipe. At discharge the ballast water is treated by 

electrolysis only. Chemicals are not required to be stored onboard. However, it was noted that 

e.g. Hydroxyl radicals, Chlorine gas and Hydrogen gas are produced and should be regarded as 

Active Substances and Relevant Chemicals. In addition a number of Disinfection By-Products 

(DPB) were identified by the Applicant and should be regarded as Relevant Chemicals. 

0.3 The required concentrations of Active Substances in seawater, measured as Total 

Residual Oxidants (TRO), are stated in the submission to reach a maximum of 2 mg/L. 

The Group noted that no such levels were given for fresh water. Therefore, the Group considers 

the concentration of 2 mg/L as both the Maximum Dosage and the Maximum Allowable 

Discharge Concentration according to G9. 

0.4 The Group noted the Applicants explanation that the high levels of disinfection 

by-products such as THM were due to the fact that the EctoSys® system was run differently in the 

land based tests than it will be run during normal operation onboard ships. No information from 

analyses were provided from samples taken in land based tests with the electrodes run as the 

applicant states is the normal way on board ships. This was found to be a significant 

shortcoming in the application. 

0.5 The Group noted that no detailed information about the control system which could 

ensure that the maximum designed TRO-concentration is maintained was included in the 

CleanBallast! system application dossier. However, the dossier did indicate that an algae 

monitoring sensor is to be included in the industrialized version of the system installed onboard 

ships. This sensor was still under development and the Group therefore concludes that the 

control system was not fully developed at the time of application. 

0.6 The Applicant carried out hydrogen measurements in a full-scale system. The lowest 

explosion limit for hydrogen gas is 4% under standard conditions. The highest measured value 

was 0.25%, which is 16 times below the explosion limit. It is also noted that a de-aeration 

component has been added immediately following the electrolysis phase and that a hydrogen 

content monitor has been included to monitor the discharge from the de-aeration pipe that will 

shut down the system should hydrogen concentrations at this point reach dangerous levels. 

The Group considers that the information provided together with the mitigation measures 

incorporated are acceptable in addressing this identified risk. The group recognized that the 

formation of oxygen in a full-scale test has not been investigated. 
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0.7 The Group noted that chronic aquatic toxicity studies were not carried out in a land-based 

installation as required by the G9 guideline, but in a lab-based installation. The Applicant 

emphasizes that it is the TRO concentration which is relevant in relation to the toxicity of the 

treated water and not the scale of the installation. However, the Group considers that it is both 

the level of TRO and the organic matter concentration which determine the quantity of 

halogenated by-products (DBP) and therefore also to some extent the toxicity of the treated 

water. Toxicity tests with water samples from the land based efficacy tests as required by the G8 

and G9 guidelines are intended to ensure that adequate levels of TRO and organic matter are used 

in all tests and that the chemical characterisation of treated water is adequately assessed. 

0.8 The Group considered that Brominated DBPs (Disinfection By-Products) are the 

toxicologically relevant compounds generated by the process. As the applicant was unable to provide 

adequate information regarding human exposure, e.g. as indicated in GESAMP-BWWG 3.9 and 

MEPC 57/2/3), the Group noted that an adequate conclusion as to the outcome of the Human 

Risk Assessment could not be achieved. Therefore, the Group recommended that human 

exposure when handling ballast water treatment operations should be restricted and RMM put 

in place. 

0.9 The Group noted that tests to determine the corrosive properties of the treated ballast 

water had yet to commence, and therefore the level of the potential risk of accelerated corrosion 

to the ballast water piping and structure that may be raised by use of this system remains to 

be assessed. 

0.10 Based on information provided in the application for Basic approval a PEC/PNEC ratio 

of discharged ballast water in Rotterdam harbour can be calculated to be 0.85, i.e. below 1 and 

indicating no cause for concern. Based on this ratio, the Group concludes that under the 

conditions of the test there would be a low risk for the environment. However, it is not clear to 

the Group whether the system will really operate as stated, given that the control system is not 

fully developed and the EctoSys® was run differently in the land based tests than it will be in 

normal operation onboard ships. 

0.11 For a final risk assessment to the environment the Group needs a better explanation of 

the presence and performance of the algae or other monitor in addition to information on the 

validity and applicability of the model used. Calculations with the MAMPEC-model are 

recommended as a reference, i.e. using as many of the same parameter values as possible. 

Under the assumptions used by the applicant in running the model, there seems to be no risk to 

the environment but the Group needs more information to have confidence in the applied tools 

and methods. 

1 INTRODUCTION 

1.1 The data for this product were extracted from the submission of Germany to 

MEPC (MEPC 57/2/3) and the application dossier and additional information received following 

request of the Group to the applicant. 
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2 COMPLETENESS OF DOSSIER 

2.1 It was noted that the applicant had submitted the following material for consideration by 

the GESAMP BWWG: 

 .1 A non-confidential Application Dossier, which contains a summary of the data 

and results (MEPC 57/2/3). 

 .2 A confidential Application Dossier for Final Approval, which contains 

information about the disinfection mechanism of the CleanBallast! system, results 

from land-based efficacy tests, ecotoxicity tests, data sets of Active Substances 

and disinfection by-products. 

 .3 Further, the Applicant submitted appendices with acute and chronic toxicity test 

protocols and results from chemical analysis. 

2.2 The Group noted that the following information was not provided in the dossier: 

 .1 Long-term corrosion testing that was advised by GESAMP BWWG to be 

performed following the Basic Approval submission has not yet commenced. 

 .2 Information concerning human exposure to active substances, relevant chemicals 

and by-products or an appropriate Human Exposure Scenario (MEPC 56/2/2, 

annex 9). 

 3. A full description of the control system of the disinfection unit. 

2.3 After request of the Group the Applicant submitted the following information: 

 .1 A summary of acute toxicity of treated ballast water to freshwater organisms with 

Chemical parameters in fresh water during the CleanBallast! LBTA process. 

 .2 Technical information of the CleanBallast! system, including a block diagram and 

a manual of the system and a description of the EctoSys® electrolytic cell. 

3 DESCRIPTION OF BWMS AND DATA-SET REQUIRED IN THE APPLICATION 

3.1 Description of the ballast water management system 

3.1.1 The proposed ballast water treatment system is a combined system intended to treat the 

ballast water at both uptake and discharge. The system consists of a 50 μm disc filtration phase 

followed by an electrochemical disinfection phase (EctoSys® electrolytic cell). 

3.1.2 At uptake the ballast water is filtered and then treated by electrolysis directly in the 

ballast water pipe. At discharge the filter is by-passed and the ballast water is treated by 

the EctoSys® component a second time. The use of secondary treatment at discharge is to 

address any potential for re-growth of organisms in the ballast tank. 
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3.1.3 The chemicals used for disinfection are directly produced by electrolysis of the ballast 

water and therefore there is no need for the storage of additional chemicals on board. Organisms 

are inactivated by indirect oxidation from Active substances and direct oxidation at the 

anode surface. 

3.1.4 The Active Substances are produced by applying a direct current between the anodes and 

cathodes affecting the full flow of ballast water. The required concentrations of Active 

Substances in seawater, measured as Total Residual Oxidants, are given by the submission as 

maximum 2 mg/L. The Group noted that no such levels were given for fresh water. 

3.1.5 The submission indicates that when run with an over potential between the electrodes the 

system can be operated in fresh water and low salinity waters. Active substances produced under 

these conditions are hydroxyl radicals. However, a different behaviour of the system could be 

expected under these circumstances and this was not investigated by the applicant. 

3.1.6 The Group noted that no information about the control system which could ensure that he 

maximum designed TRO-concentration is maintained during ballasting and deballasting was 

included in the CleanBallast! system. However, the dossier indicated that there are plans to 

incorporate an “algae monitor” as part of its control system to automatically adjust the levels of 

chemicals generated according to plankton content of the treated water. The algae monitor 

sensor is to be included in the final version of the system to be installed onboard ships. 

The CleanBallast! version used in the land based tests was therefore considered not to be the final 

version, but still under development. 

3.1.7 A de-aerator is fitted immediately after the electrolysis equipment to reduce the quantity 

of hydrogen gas in the treated water, the air vent from the de-aerator is monitored for H2 content 

for additional safety. The disc filters are automatically back-flushed to sea during the uptake of 

ballast water and are bypassed and not used for discharge treatment. 

3.1.8 The Group also noted that the description of the system indicated that it incorporated an 

automatic shut-down in case of leakage. 

3.2 Identification of 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 and low levels of chlorine gas in situ with the aid of an 

electrochemical treatment (EctoSys®). As a result, chemicals are neither required to be stored 

onboard nor generated on demand. 

3.2.2 It was recognized that the process would generate free radicals which were expected to 

have half-lives in the order of micro seconds to milliseconds, but which 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.
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3.2.3 The following Active Substances and Relevant Chemicals are identified by the dossier:

 .1 In seawater, chlorine gas (Cl2) is formed at the anode surface and exists in 

equilibrium with HOCl and OCl- depending on the pH. These oxidants will react 

with bromide ions and produce HOBr and BrO-. 

.2 Hydrogen gas is formed at the cathode surface by the electrolysis of water. 

.3 It was noted that the Applicant had identified a number of disinfection 

by-products (DPB). The Applicant focused on the formation of DBP in high 

salinity waters, as a result of the request from the Group to investigate the 

formation of chlorinated organics. 

3.2.4 Table 1 lists the concentrations of disinfection by-products supplied by the Applicant in 

the non-confidential dossier for land-based type approval tests (LBTA) for cycle 3 plus the 

values extracted from further 4 LBTA test cycles (extracted from the lab reports). Haloacetic 

acids (HAA) were analysed in 4 test cycles, only. 

Table 1: Analysis of disinfection by-products in ballast water treated with EctoSys® 

in a land-based full-scale installation 

(Ref. MEPC 57/2/3, table 1, page 11 and Appl. Dossier file 3, chapter 4). 

 Deballasting Deballasting 

Parameter Unit 

after treatment 

tank 

Effluent 

treatment Effluent control 

 1 2 3 

TOC mg/L 9.9 (2.3-29.3) 11.2 (3.25-31.1) 12.6 (4.2-34.2) 

Bromate μg/L 27 55 (26 – 87) <1 

 

Trihalomethanes 

(THM) 

Trichloromethane μg/L <0.3 <0.3 <0.3 

Dichlorobromomethane μg/L 0.2 (0.2-6) 0.54 (0.5-9) <0.1 

Dibromochloromethane μg/L 6.8 (<1-8.5) 13 (<0.1-16) <0.1 

Tribromomethane μg/L 180 (170-260) 330 (260-410) <0.1 (<0.1-0.1) 

Sum THM μg/L 190 (180-270) 340 (270-430) 0 (<0.1-0.1) 

 

Haloacetic acids 

(HAA) 

Monochloroacetic acid μg/L 0.14 (<0.1-1.3) 0.57 (0.57-0.76) <0.1 (<0.1-0.12) 

Dichloroacetic acid μg/L 0.12 (0.12-0.26) 0.26 (0.26-0.44) <0.1 

Trichloroacetic acid μg/L <0.05 (<0.05-0.16) 0.06 (<0.05-0.15) 0.08 (<0.05-0.08)

Monobromoacetic acid μg/L 0.33 (0.33-1.2) 3 (2.3-4.2) <0.1 

Dibromoacetic acid μg/L 21 (20-47) 43 (43-93) <0.1 (<0.1-0.41) 

Tribromoacetic acid μg/L 0.66 (0.66-1.3) 1.6 (1.6-2.1) <0.1 

Sum HAA μg/L 22.25 (22.3-50.1) 48.5 (48.5-100) 0.08 (0.08-0.41) 

 

AOX mg/L Cl 0.08 (0.06-0.57) 0.16 (0.08-0.23) 0.07 (<0.02-0.09)
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3.2.5 Sampling points have been determined at several places. One sampling 

point (1) represents a filtered and electrochemically (EctoSys®) treated water sample, which was 

stored in a treatment tank. Sampling point (2) represents the water sample from the treatment 

tanks, which were treated with EctoSys® a second time before discharge, whilst sampling 

point (3) represents an untreated sample (see Table 1). 

3.2.6 Bromate concentration was measured during the full-scale tests, but due to matrix effects 

the LOQ was found to be 0.2 mg/L. All measured bromate concentrations were <0.2 mg/L. 

Therefore, the applicant additionally analysed bromate during the chronic toxicity studies with 

ICP-MS, where a small-scale laboratory-based CleanBallast! unit was applied. The applicant 

states that the scale of the installation is of no significance for the formation of bromate, but the 

level of Total Residual Oxidants is significant. 

3.2.7 Based on the results for trihalomethanes the US-EPA limit for drinking water (80 μg/L) 

has been exceeded by a factor of 2.75 on average. However, the applicant states that the 

electrodes worked under reversed polarity, which creates higher THM concentrations. 

In a lab-based study during chronic toxicity tests, the THM concentration was found to 

be 34.45 μg/L at a TRO concentration of 2 mg/L. No information on analytical chemistry were 

provided from samples taken in land based tests with the electrodes run as the applicant states is 

the normal way on board ships (see paragraph 3.2.9). 

3.2.8 The US-EPA limit of 60 μg/L for total haloacetic acids was exceeded in two cases 

(71 and 100 μg/L) during deballasting with EctoSys® treatment. 

3.2.9 The Group noted that the applicant had provided the following additional information to 

explain the reason for the high levels of chemicals produced as by-products by the system: 

Clarification of high THM concentrations by Member State 

“In order to prevent mineral hydroxide deposits from seawater on the cathode surface, 

the polarity of the electrodes is reversed in certain time intervals. During normal 

operation the last electrode is working at cathodic potential reducing effectively THM 

formed previously in the cell. At reversed polarity, the last electrode before the water 

leaves the cell is working at anodic potential at which the applied current partly forms 

TRO. When the cell ends with an anode, the THM formed as disinfection by-product from 

anodically produced TRO can not be further reduced at any cathodic surface. This result 

in higher THM concentration compared to running the electrochemical cell with normal 

polarity. Due to relatively frequent polarity reversal, the treated water originates from 

both normal and reversed operation mode of the EctoSys® resulting in a mean THM 

concentration during common operation of the CleanBallast! system. In contrast, in the 

test cycle, which results are shown in Table 1, the reversed mode alone was used during 

both the ballasting and deballasting procedure and therefore presents the highest THM 

concentrations possibly produced and an unrealistic worst-case due to normally applied 

reversal (Ref. MEPC 57/2/3, 3.5.2.1.1).” 
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3.3 Data on effects on aquatic plants, invertebrates and fish, and other biota, including 

sensitive and representative organisms 

3.3.1 Acute aquatic toxicity 

3.3.1.1 Haloacetic acids (Ref. extracted from MEPC 57/2/3, 3.5.2.1.4) 

Toxicity of HAA on two aquatic plants (Myriophyllum, L. gibba) was investigated in the 

laboratory by Hanson et al. (2004, I and II). HAA have low toxic effect in the mg/L range for 

EC10 and in the g/L range for EC50. MCAA was generally the most toxic. 

3.3.2 Chronic aquatic toxicity 

3.3.2.1 Bromate 

Concentrations of up to 13.6 mg/L bromate stimulates cell division of phytoplankton cells. 

Chronic toxicity of bromate was calculated by Hutchinson et al. 1997 by applying a factor 

of 10 to the acute toxicity value (31 mg/L), i.e. 3 mg/L. 

Table 2: Data on chronic aquatic toxicity of bromate 

 Organism Bromate mg/L Reference 

Freshwater Daphnia magna 48 h LC50 179 

Marine Mysid shrimp 96 h LC50 176 

Marine Juvenile fish 96 h LC50 427-512 

Marine Early life stages 

of fish 

96 h LC50 31 

Review by 

Hutchinson et al. 1997 

MEPC 57/2/3, 3.5.2.1.4 

The Applicant states that DBP can only form in water with higher salinities and that 

concentrations of DBP are in the range of drinking water standards. 

3.4 Data on mammalian toxicity (G9: 4.2.1.2) 

3.4.1 Free Active Chlorine (Cl2, HOCl, OCl-, and OH radicals) 

The Group noted that the toxicological dataset for the active substances has been already 

provided for Basic Approval (MEPC 55/2/4). 

3.4.2 Disinfection By-Products (DBP) 

3.4.2 Trihalomethanes (Ref. MEPC 57/2/3, 3.5.2.1.4) 

3.4.2.1 Acute toxicity

The acute toxicity (LD50) of trihalomethanes (chloroform, bromodichloromethane, 

chlorodibromomethane and bromoform) to rats has been found to be in the range of 848-1388 

mg/kg (Chu et al.., 1980). Clinical effects following single oral doses were sedation, ataxia, 

piloerection, and prostration. In this study, bromoform was the least toxic compound. 
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Chloroform (GHS classification, Annex VI, COM (2007) 355 final), bromodichloromethane and 

chlorodibromomethane (self classification by commercial suppliers) are all classified as harmful 

if swallowed. On the other hand, bromoform is classified as toxic by inhalation 

(GHS classification, Annex VI, COM (2007) 355 final). Bromate (as potassium bromate) is 

classified as toxic if swallowed (GHS classification, Annex VI, COM (2007) 355 final). 

3.4.3 Genotoxicity/Carcinogenicity 

Chloroform and other THM have been shown to increase tumours of the liver, kidney or large 

intestine in rats and mice. The weight of evidence suggests that chloroform is non-genotoxic and 

there are data, to indicate that tumours only occur at high doses where there is also tissue damage 

(Fawell, 2000). 

The evidence suggests that the use of a threshold approach, based on the tolerable daily 

intake (TDI) would be the most appropriate way of determining safe levels in drinking water 

(WHO, 1998). The application of this standard to ballast water is however unclear. 

Chloroform is classified according to its carcinogenic properties (suspected of causing cancer) 

(GHS classification, Annex VI, COM (2007) 355 final), this conclusion also applies to 

bromodichloromethane (self classification by commercial suppliers). Bromate (as potassium 

bromate) is classified according to its carcinogenic properties (may cause cancer) 

(GHS classification, Annex VI, COM (2007) 355 final). 

3.4.5.2.3 Toxicokinetics/Metabolism 

Chloroform, bromodichloromethane, chlorodibromomethane and bromoform are stored and 

metabolised rapidly in human body fluids with relatively rapid clearance rates (Batterman 

et al., 2002), depending on the lipophilic properties (partition coefficients) of the 

concerned THM. 

3.4.6 Modes of degradation (biotic; abiotic) 

3.4.6.1 Haloacetic acids (Ref. MEPC 57/2/3, 3.5.2.1.4) 

Dichloroacetic acid (DCAA), the third highest ballast water effluent concentration, is rapidly 

biodegradable (Rodriguez et al., in press). MCAA is expected to degrade even faster, due to less 

halogen in the molecule. 

4 HUMAN HEALTH ASSESSMENT 

4.1 The assessment of the human health risks of the EctoSys Ballast Water Treatment system 

has already been evaluated by the Group at Basic Approval. The general conclusion was: 

4.2 From the supplied information it was concluded that the critical health effects resulting 

from human exposure to the active substances and relevant compounds existing in the solution 

are mostly acute in nature; however, some concerns are also addressed in literature related to 

toxicity to respiratory and developmental/reproductive function and carcinogenicity, depending 

on the severity of exposure and presumably under long term exposures (e.g., occupational 

scenarios). 
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4.3 Other relevant factors have also to be taken into account when assessing human exposure 

towards chemicals include, inter alia: 

.1 the variability in individual sensitivity; 

.2 the fact that complex mixtures of disinfectants and DBPs, according to current 

knowledge, interact in an additive way, at low concentration. 

4.4 The Group expressed concern regarding the potential for cumulative toxicological effects 

of the mixture of chemicals generated by EctoSysTM . 

5 RISK TO SAFETY OF SHIP AND CREW 

5.1 Risk to safety of ship 

5.1.1 Hydrogen formation 

Hydrogen gas can be formed during the electrolytic disinfection process. The reaction 

mechanism was described in the Application for Basic Approval, MEPC 55/2/4). In the 

recommendations the Group made at Basic Approval, further investigations on potential 

hydrogen gas formation in full-scale ballast water treatment systems were considered necessary 

and that the application of a safety factor of at least 2 should be applied. 

The Applicant declares that it is impossible to build up explosive concentrations (≥4%) of 

hydrogen gas in the ballast water tanks when using the CleanBallast! system, as the ballast water 

tanks are open to venting during ballasting and deballasting. 

The Group noted that the applicant has performed further tests and calculations to determine the 

levels of hydrogen concentrations that may be experienced during operation of the system. 

It is also noted that a de-aeration component has been added immediately following the 

electrolysis phase and that a hydrogen content monitor has been included to monitor the 

discharge from the de-aeration pipe that will shut down the system should hydrogen 

concentrations at this point reach dangerous levels. The Group considers that the information 

provided together with the mitigation measures incorporated are acceptable in addressing this 

identified risk. 

5.2 Corrosion effect tests (Ref. MEPC 57/2/1, 5.1.2) 

The Group noted that the long-term corrosion testing that had been advised was to be performed 

following the Basic Approval presentation has not yet commenced. 

5.3 Risks to human health 

The Group considered in the Basic Approval, that the critical health effects associated with 

human exposure to the active substances generated by the CleanBallast are mostly acute in 

nature. This concern was reiterated during Final Approval submission and therefore RMM 

remain to be clearly identified and implemented. 
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Additionally, the Group raised concern in the Basic Approval regarding exposure to the relevant 

DBP compounds such as chlorinated and brominated under occupational scenarios. The Group 

considered that human health concerns remain in the Final Approval application as there is 

uncertainty regarding the THM concentrations that can be generated by the system, namely by 

electrodes working under reversed polarity. It is acknowledged that the DBP, especially 

bromate, chloroform and bromoform have a potential for bioaccumulation and human 

genotoxicity/carcinogenicity and will therefore have to be kept below toxicologically critical 

levels (bromate <10μg/L; bromoform <100μg/L; chloroform <200 μg/L, WHO Guidelines for 

Drinking Water Quality, 2003). 

Bromate concentrations were measured at the sampling points during the deballasting (DB) part 

of the treatment process with values of 27 μg/L and 55 μg/L (see Table 1). Additionally, the 

concentrations measured for haloacetic acids during deballasting with EctoSys® treatment, 

exceeded the US-EPA limit of 60 μg/L. Although the applicant states that the scale of the 

installation is of no significance for the formation of bromate, the level of Total Residual 

Oxidants is considered to be significant and therefore the Group considered that there is a risk 

that unacceptable levels of bromate and brominated DBP can be produced by the system. 

As the current MCL (Maximum Contaminant Level) in the USA for bromate 

(potassium bromate) is 10 μg/L, and the maximum contaminant level goal is zero, the Group 

considers that the human health concern towards exposure to levels of bromate generated by the 

system still remain to be fully clarified namely by applicant submission of data relating to a 

human exposure scenario where bromate and other chlorinated and brominated DBP may 

be present. 

The Group noted that the applicant did not provide any information concerning human exposure 

or attempt to describe a Human Exposure Scenario (MEPC 56/2/2, annex 9); therefore an 

adequate conclusion as to the outcome of the Human Risk Assessment could not be achieved. 

The Group recommended that human exposure when handling ballast water treatment operations 

should be restricted and RMM put in place.

6 RISKS TO THE AQUATIC ENVIRONMENT 

6.1 ASSESSMENT OF PERSISTENCE (P), BIOACCUMULATION (B) AND 

TOXICITY (T) 

6.1.1 Persistence (G9: 5.1.1.1) 

This aspect was evaluated during Basic Approval. It was concluded that none of the chemicals 

used in the EctoSys Ballast Water Treatment system was to be considered as a PBT substance. 

6.1.2 Does the Active Substance, Preparation and/or Relevant Chemicals meet all three 

PBT criteria? 

Conclusions on PBT are already evaluated under Basic Approval. The Group concluded that 

none of the substances used in this BW system should be classified as PBT substances. 
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7 ASSESSMENT OF TREATED BALLAST WATER 

7.1 Toxicity tests 

7.1.1 Acute toxicity of whole effluents in LBTA tests 

7.1.1.1 Brackish water 

The Group noted that acute toxicity tests were carried out with the treated ballast water from a 

land based installation (G9: 5.2.3). Tests were performed with brackish water and with 

organisms of only one trophic level. In parallel, the degradation of Total Residual Oxidants 

(TRO) was determined. 

A so-called ‘Kinetic’ ecotoxicity study was carried out with Tetraselmis suecica during the 

LBTA tests, during the deballasting procedure, samples being taken at a distance of 1 m away 

from the point of discharge and 30 cm below the water surface. 

Table 3: Results of the Ecotox studies (Viability of Tetraselmis s.) and TRO concentrations 

for the LBTA cycle 3 

Sampling location & time Viability TRO [mg/L] 

 Control Treated Corners Control Treated Corners

Untreated harbour water 0.649 0.155 

*DP 10 min deballasting 0.584 0.581 0.150 

*DP 20 min deballasting 0.622 0.699 0.194 

*DP 5 min after end of 

deballasting 0,640 0.668 0.154 

*DP 10 min after end of 

deballasting 0.598 0.637 0.130 

Right corner, before discharge 0.625 0.133 

Left corner, before discharge 0.621 0.142 

Right corner, 30 min after 

discharge 0.622 0.137 

Left corner, 30 min after 

discharge 0.642 0.148 

 * DP= discharge point 

The EC50 of the whole effluent was determined by measuring the reduction of fluorescence of the 

marine bacterium Vibrio fischeri at predetermined time intervals after ballast water treatment and 

after sampling. All other measurements revealed that the EC50 was not reached. 

A high toxicity of the untreated control samples were related to high H2S concentrations in the 

storage tank caused by sulphate reducing bacteria. 
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Table 4: Acute toxicity on whole effluent 

FCA Species Salinity 

[PSU] 

Time after 

treatment 

EC50 

(mL/L) References/Comments 

B Vibrio fischeri

bacteria 

Brackish 

water 10 min >500 ISO 11348-2-L34 MEPC 57/2/3, 3.7.1.1.3 

B Vibrio fischeri

bacteria 

Brackish 

water 10 min 600 MEPC 57/2/3, 3.7.1.1.3 

A Phaeodactylum 

tricornutum

Brackish 

water 380 MEPC 57/2/3, 3.7.1.1.4 

A Phaeodactylum 

tricornutum

Brackish 

water 500 MEPC 57/2/3, 3.7.1.1.4 

Toxicity tests with several marine organism were carried out. In the Table below an overview of 

the results is given. The data concern the treated ballast water. 

Table 5: Marine organism toxicity test with treated ballast water 

T Species L(E)C50 Value Unit Remark 

B Light bacteria sp. 3h-EC50 100 % EC50 not reached 

B Light bacteria sp. 50m-LC50 100 % EC50 not reached 

A P. tricornutum 72h-EC50 9 % Inhibition 

B Light bacteria sp. 30m-LC50 32 % 

A P. tricornutum 72h-EC50 38 % Inhibition 

B Light bacteria sp. 30m-LC50 31 % 

A P. tricornutum 72h-EC50 23 % Inhibition 

 T refers to type of organism: B = bacteria, = A = algae. 

The Applicant states that acute toxicity studies with marine algae on the whole effluent were 

submitted with the Basic Approval already (MEPC 55/2/16, annex 7, paragraph 8.2). 

7.1.1.2 Freshwater studies 

The Applicant also carried out toxicity tests under freshwater conditions, which were delivered 

following a request from the Group. However, the worst case TRO concentration of 2 mg/L 

could not be achieved in freshwater. The test organisms used were the invertebrate 

Daphnia magma, the algae Scenedesmus sp. and the vertebrate Danio rero. 

7.1.2 Chronic toxicity of whole effluents in LBTA tests 

The Group noted that due to the rapid decay of TRO and DBP, the chronic toxicity studies were 

carried out using a separate ballast water treatment installation (10 m3

/h) at the laboratory 

performing the studies. Further, the applicant states that the TRO level and not the scale of the 

installation is relevant. The test water was seawater (32-35 PSU) filtered at <10 μm with a 

constant TRO level of 2 mg/L. This water was led continuously to the test basins to maintain a 

constant supply of high TRO level water to the test organisms. The results are summarized 

in Table 5. 
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Table 5: Chronic toxicity tests with treated ballast water and 2 mg/L TRO 

(b = biomass, r = reproduction, s = survival, h = hatch, l = length, 

w + dry weight, n.d. = not determinable) 

FCA Species Effect Value Reference 

A [%] Skeletonema 

costatum 

96 h EbC50 

NOECb 

96 h ErC50 

NOECr

3.9 

n.d. 

6.3 

3.2 

ISO 10253:1995(E) 

MEPC 57/2/3, 3.7.2.2 p. 26 

C [%] Tisbe battagliai 21 d NOECs 

21 d NOECr 

21 d LOECs 

21 d LOECr

1.0 

3.2 

3.2 

10 

OECD 211 (marine equivalent) 

MEPC 57/2/3, 3.7.2.3 p. 27 

F [mg/L] Cuprinodon 

Variegates 

(Sheepshead 

Minnow) 

32 d NOECh 

32 d NOECs 

32 d NOECl 

32 d NOECw 

Total NOEC 

32 d LOECh 

32 d LOECs 

32 d LOECl 

32 d LOECw 

Total LOEC 

3.2 

1.0 

10 

10 

1.0 

10 

3.2 

>10 

>10 

3.2 

OECD 210 

MEPC 57/2/3, 3.7.2.3 p. 27 

The reported water quality parameters for the chronic toxicity studies were: 

pH: 7.98 – 8.17 

Salinity: 34.5 – 35.2 PSU 

Ammonium N: <10 μg/L 
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7.2 Degradation of TRO 

The Group noted that TRO decay was determined in the dark to prevent photocatalytic 

degradation. These data confirm the previous results and statements (MEPC 55/2/4, 

paragraph 5.2.7.2) that the TRO degrades rapidly during the first 20 minutes. Figure 1 shows 

measured TRO decay over the initial time period after treatment in undisturbed stored samples 

(sample port C) during five LBTA deballasting procedures in brackish water. 

TRO degradation in CleanBallast! deballasting effluent

0.0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

1.6

1.8

0 20 40 60 80 100 120 140 160

Time [min]

TRO [mg/l]

LBTA cycle 1

LBTA cycle 2

LBTA cycle 3

LBTA cycle 4

LBTA cycle 5

Figure 1: TRO decay in stored effluent from the LBTA type approval set-up 

(without discharge to the receiving water) 

From these data it can be concluded that the half life of TRO is about 30 minutes. 

7.3 Prediction of discharge and environmental concentrations 

7.3.1 Emission scenario of active substance 

In their application for Basic Approval, the Applicant reported carrying out modelling studies of 

ballast water discharges in generic, open and closed harbours as well as case studies of ballast 

water discharge in Bremerhaven, based on the worst-case acute NOEC values of the disinfection 

unit effluent (MEPC55/2/4). This was complemented with new simulations at the actual site of 

the land-based type approval installation (Bremerhaven). To confirm model predictions, on-site 

measurements at the land-based installation with direct TRO measurements were carried out. 

The measured TRO concentrations were below the predicted concentrations and according to the 

applicant showed that the model calculates worst-case concentrations. TRO concentrations 

would account for <7% of the harbour concentrations shortly after effluent discharge and would 

be diluted and degraded to <1 ng/L after 7.5 h. 

Furthermore, the Applicant carried out a case-study based on the Port of Rotterdam using the 

MAM-PEC model. The worst-case scenario for the Port of Rotterdam with all ships using the 

CleanBallast! system and synchronous discharge revealed a total concentration of 0.12 μg/L TRO. 
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Case studies of ballast water discharge based on Bremerhaven were also carried out. The model 

predictions were also controlled by manually taking samples at different distance from the 

discharge point, and measured for TRO. Other model parameters can be found in the 

Application Dossier. 

The simulations included two cases: 

.1 Dilution down to 0.3% v/v, the acute NOEC including a safety factor of 10 

(Basic approval, MEPC 55/2/4, 9.3). 

.2 Dilution down to 0.1%, the chronic NOEC for the whole effluent including a 

safety factor of 10 (Final approval, MEPC 57/2/3). 

With the discharge scenarios defined by the number of ships, their positions and certain loads, the 

model was used to predict the time taken for concentrations to fall below 0.3% and 0.1%, 

respectively, of the raw effluent concentration. With the first-order degradation rate set to fit real 

data measured in Bremerhaven during the LBTA test cycles, the results could be summarized in 

Tables 7 and 8. 

Table 7: Harbour modelling results for a closed harbour 

Discharge 

rate 

(m3/h) 

Discharge 

duration 

(h) 

Time for 

concentration to 

reach 0.3% 

(h) 

Time for 

concentration to 

reach 0.1% 

(h) 

1000 5 4 5 

1000 10 4 5 

5000 5 6 7 

5000 10 6 7 

Table 8: Generic harbour modelling results for a tidal harbour 

Discharge 

rate 

(m3

/h) 

Discharge 

duration 

(h) 

Time for 

concentration to 

reach 0.3%) 

 (h) 

Time for 

concentration to 

reach 0.1% 

 (h) 

1000 5 2 2 

1000 10 2 3 

5000 5 3 4 

5000 10 3 5 
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7.4 Comparison of effect assessment with discharge toxicity 

The applicant provided the following information regarding risk modelling: 

“Physical processes (i.e. mixing), will be different for every port and variable within a 

port, depending primarily on factors such as fresh water input dynamics, tides, and 

winds. Mixing will have two components, vertical and lateral, to disperse the oxidant 

away from the ship’s point of discharge. To assess the potential effect of mixing, the 

overall decay half-life of the oxidant has to be considered. 

Modelling of the ballast water discharge dilution in generic harbours down to the acute 

NOEC (using a safety factor of 10) resulting from the Final Approval toxicity tests, and 

also down to the chronic NOEC (incl. safety factor) was performed as a more direct 

supplement to the toxicity studies. A specific generic harbour scenario was developed 

using available data from the harbour of Rotterdam. This specific latter study was used 

to determine a realistic PEC/PNEC ratio, provided all ships in a representative 

commercial harbour were equipped with the proposed CleanBallast! system and under 

worst-case treatment and discharge conditions. This might also be of use in later 

joint-efforts of developing an ESD for BWT (paragraph 3.8.4 of the application dossier).”

8 ENVIRONMENTAL RISK ASSESSMENT 

8.1 PNEC and NOEC 

In order to estimate the PNECTRO-saltwater value, the corresponding value for TRC in sea water 

of 0.3 μg/L was taken, including a safety factor of 10. This value is derived from the dilution of 

the effluent, plus the degradation of TRO in natural water to result in a PEC. 

It was noted that the LOEC of three marine organisms under long-term exposure conditions to 

the whole effluent was 1% effluent v/v. Therefore, the PNEC for the whole effluent would 

be 0.14 μg/L according to the Basic Approval dossier. 

8.2 PEC 

The Group noted that a steady state PEC of the TRO in Rotterdam under a worst case condition 

was predicted by the MAM-PEC model to be 0.12 μg/L 

8.3 Calculation of PEC/PNEC ratios

The PNECTRO-saltwater value evaluated by the Group during Basic Approval was 0.14 mg/L 

including a safety factor of 10. Therefore the PEC/PNEC ratio is 0.12/0.14 = 0.85. Based on 

this ratio the Group concludes that under the conditions of the test there would be no risk for the 

environment. However, it is not clear to the Group whether the system really operates like this 

as the presence and working of the algae monitor is not sufficiently described. 
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8.4 Assessment of the risk characterization 

8.4.1 The Group cannot yet agree to accept the risk characterization and risk assessment as 

carried out by the applicant, as the functioning of the algae monitor was not clearly described nor 

was it finally developed. If the re-growth of algae is relatively small but high enough to trigger 

the treatment at discharge the level of TRO discharged may be relatively high as only a minor 

part will be used as oxidative agent to remove the organisms from the ballast water. 

8.4.2 The applicant has used a different model to MAMPEC, for which the Group is not aware 

of the specific characteristics nor was the group informed about possible reasons to use this 

model instead of MAMPEC. The Group needs at least some benchmark results to judge the 

comparability between both models. 

8.4.3 The Group concludes that the quality of test reports on whole effluent toxicity testing 

with treated ballast water is considered sufficient.

9 CONCLUSIONS AND RECOMMENDATIONS 

9.1 Risks to the safety of the ship 

The Group noted that the risk of explosion due to the generation of Hydrogen gas in the 

electrolysis process identified during the assessment for Basic Approval of this system had been 

fully considered by the applicant. A de-aerator has been incorporated in the system as an 

additional risk mitigation measure, including a hydrogen monitor in its vent arrangement that 

will shut down the system should dangerous level of hydrogen be detected. The Group 

therefore considers that this risk has been adequately addressed and controlled by the applicant. 

The Group noted that tests to determine the corrosive properties of the treated ballast water had 

yet to commence, and therefore the level of the potential risk of accelerated corrosion to the 

ballast water piping and structures due to the use of this system remain to be assessed. 

9.2 Risks to the crew and general public 

Chlorinated and Brominated DBPs (Disinfection By-Products) are the toxicologically relevant 

compounds due to their human genotoxicity/carcinogenicity potential generated by the process. 

As the applicant did not provide information concerning potential for human exposure or 

describe a Human Exposure Scenario (MEPC 56/2/2, annex 9), the Group noted that a conclusion 

as to the outcome of the Human Risk Assessment could not be reached. The Group, therefore, 

can only adopt a precautionary approach and recommend that human exposure when handling 

ballast water treatment operations should be restricted and Risk Mitigation Measures be put 

in place.

9.3 Risks to the environment 

9.3.1 The Group noted that both “the maximum dosage concentration” using two treatments 

and “the maximum allowable discharge concentration” for TRC are the same for this system. 

In general, the maximum dosage concentration is chosen to ensure efficacy to all marine 

organisms. Thus this dose concentration (2 mg/L) exerts sufficient acute aquatic toxicity to kill 

all the organisms even in high densities as defined in G8. If the second treatment during 

deballasting was carried out at the same dosage of 2 mg/L, this will clearly have significant 

ecotoxicity to organisms in the receiving water and be entrained into the discharge plume. 
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The Group was of the opinion that the discharge of large volumes of ballast water treated with 

the CleanBallast! system using EctoSysTM system might result in TRO concentrations in the 

receiving environment that might cause acute toxic effects to aquatic organisms 

(refer MEPC 55/2/16, annex 7, paragraph 9.3.4). 

9.3.2 The Group noted that the application shows that clear short-term effects can occur, so 

that the ballast water discharge still has non-acceptable risks to marine ecosystems, even if the 

long-term risks, such as PEC/PNEC ratio, described in 6.3.5 are acceptable. The Group 

emphasized that more mitigation procedure at second treatment should be considered. 

9.3.3 The group has already recommended to the applicant for the mitigation of discharging 

second treatment water with high acute toxicity at the basic approval (MEPC 55/2/16, annex 7, 

paragraph 0.7 and 10.4.2.4), as follows. 

As the treated ballast water showed signs of relatively high toxicity, the Group recommended 

that ballast water treated with the EctoSys system would require a relatively high dilution 

immediately after discharge into the environment in order to avoid acute toxic effects.

Furthermore, the Group recommends that the following conditions should apply during the 

further development and testing of the proposed system: ...... it might be worthwhile to explore 

possibilities to fine-tune the EctoSysTM system so treatment at de-ballasting can be avoided or at 

least reduced, as this seems to create a relatively high initial toxicity of the treated ballast water 

at discharge.

9.3.4 The Group was of the opinion that the technical evidence to ensure that the maximum 

dosage remains below 2 mg/L is not clear in this final application. However, at the final 

approval, the dossier identifies that “Studies have shown that the CleanBallast! system always 

fulfils performance and other requirements at initial (directly after the advanced electrochemical 

treatment step) concentrations of 2 mg/L Total Residual Oxidants (TRO) or below in the 

discharge water.” Thus, the Group noted that using EctoSysTM in CleanBallast! system, some 

control scheme for over-potential TRC production to reduce the maximum dose from 4 to 2 mg/L 

is needed at both treatments. The application dossier does not contain the description of how the 

typical TRC capacity is limited and controlled during operation. 

9.3.5 The applicant provided an additional feature using “the algae monitor” to control the 

CleanBallast! system. It is not the task of GESAMP BWWG to evaluate the performance of this 

monitor; how this monitor can count the viable number of phytoplankton. However, the 

information of algae monitor is not completely disclosed to the Group from applicant, so that the 

Group cannot to evaluate its performance and reliability at all.

9.3.6 Regarding the total system including this new algae monitor, the Group was concerned 

that the applicant was unable to provide sufficient information on this essential component. 

The Group noted that the algal monitor had not yet been tested in an operational system. 

Therefore, the Group considers that as this Self-Protection procedure is not yet proven in practice 

and the confidence in the maintenance of the maximum allowable discharge concentration of 

TRO at any time, cannot be ensured at this phase. The group was of the opinion that the algae 

monitor seems to be used for the measurement of biological density or efficacy levels and not for 

the measurement of the chemical properties such as TRO levels. Considering the whole system 

design, even if the algae monitor sensor has enough performance and reliability, the total system 

should first be proven in practice. 
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9.3.7 The Group also has noted at basic approval that there are possibilities that during the 

second treatment greater quantities of relevant chemicals may be produced than at the first 

treatment (refer MEPC 55/2/16, annex 7, 7.2.5). The Group strongly recommended that for the 

second treatment, the maximum dose of 2 mg/L should be reduced to a minimum needed to 

achieve the demand for G8 efficacy. Further, if the algae monitor works in practice, the second 

treatment should be stopped, when there are no viable organisms in the discharged ballast water. 

9.3.8 For a final environmental risk assessment the Group needs a better explanation of the 

presence and performance of the algae monitor and information on the validity and applicability 

of the model used. For reference reasons also calculations with the MAMPEC-model are 

recommended using as many as possible the same parameter values. Under the assumptions of 

the applicant there seems no risk for the environment but the Group needs more confidence in 

the applied tools and methods. 

9.4 Recommendations 

 .1 Final Approval of the CleanBallast! System the Ectosys technology is not

recommended to be granted based on the submission provided by Germany. 

 .2 The Group noted that the proposed system treat the ballast water both on uptake 

and at discharge. The use of a secondary treatment at discharge is to address any 

potential for re-growth of organisms in the ballast tank. At uptake the ballast 

water is filtered and then treated by electrolysis directly in the ballast water pipe. 

At discharge the ballast water is treated by electrolysis only. Chemicals are not 

required to be stored onboard. However, it was noted that e.g. Hydroxyl radicals, 

Chlorine gas and Hydrogen gas are produced and should be regarded as Active 

Substances and Relevant Chemicals. In addition a number of Disinfection 

By-Products (DPB) were identified by the Applicant and should be regarded as 

Relevant chemicals. 

 .3 The required concentrations of Active Substances in seawater, measured as 

Total Residual Oxidants, are given by the submission as maximum 2 mg/L. 

The Group noted that no such levels were given for fresh water. Therefore, the 

Group considers the concentration of 2 mg/L as both the Maximum Dosage and 

the Maximum Allowable Discharge Concentration according to the 

G9-evaluation, respectively. 

 .4 The Group noted that the Applicant had explained that high levels of disinfection 

by-products such as THM were due to the fact that the EctoSys® system was run 

differently in the land based tests than it will be in normal operation onboard 

ships. The Group further considered that a full chemical characterization of water 

treated by the CleanBallast! system run in normal mode should be provided 

together with toxicity tests with the same water. 

 .5 The Group noted that no detailed information about the control system which 

could ensure that the maximum designed TRO-concentration is maintained was 

included in the CleanBallast! system. However, the dossier indicated that an algae 

monitor sensor is to be included in the industrialized version of the system 

installed onboard ships. This sensor was still under development and the Group 

therefore concludes that the control system was not fully developed and therefore 

not an integrated part of the system under evaluation by the Group. 
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 .6 The Applicant carried out hydrogen measurements in a full-scale system. 

The lowest explosion limit for hydrogen gas is 4% under standard conditions. 

The highest measured value was 0.25%, which is 16 times below the explosion 

limit. It is also noted that a de-aeration component has been added immediately 

following the electrolysis phase and that a hydrogen content monitor has been 

included to monitor the discharge from the de-aeration pipe that will shut down 

the system should hydrogen concentrations at this point reach dangerous levels. 

The Group considers that the information provided together with the mitigation 

measures incorporated are acceptable in addressing this identified risk. The group 

recognised that the formation of oxygen in a full-scale test has not been 

investigated. 

 .7 The Group noted that the long-term corrosion testing that had been advised in the 

Basic approval evaluation has not yet commenced. 

 .8 The Group noted that chronic aquatic toxicity studies were not carried out in a 

land-based installation as required by the G9 guideline, but in a lab-based 

installation. The Applicant emphasizes that it is the TRO concentration which is 

relevant in relation to the toxicity of the treated water and not the scale of the 

installation. The Group considers both the level of TRO and organic matter 

essential for the quantity of halogenated by-products (DBP) and therefore also for 

the toxicity of the treated water. Toxicity tests with water samples from the land 

based efficacy tests as required by the G8 and G9 guidelines will ensure that 

adequate levels of TRO and organic matter is used in all tests and the chemical 

characterisation of treated water. 

 .9 The Group considered that Brominated DBPs (Disinfection By-Products) are the 

toxicological relevant compounds generated by the process. As the applicant 

couldn’t provide information concerning the Human Exposure Scenario 

(3.9. MEPC 57/2/3), the Group noted that an adequate conclusion as to the 

outcome of the Human Risk Assessment could not be achieved. Therefore, the 

Group recommended that human exposure when handling ballast water treatment 

operations should be restricted and RMM put in place. 

 .10 The Group noted that the risk of explosion due to the generation of Hydrogen gas 

in the electrolysis process identified during the assessment for Basic Approval of 

this system had been fully considered by the applicant. A de-aerator has been 

incorporated to the system that includes a hydrogen monitor in its vent 

arrangement that will shut down the system should dangerous level of hydrogen 

be detected as an additional risk mitigation measure. The Group therefore 

considers that this risk has been adequately addressed and controlled by 

the applicant. 

 .11 The Group noted that tests to determine the corrosive properties of the treated 

ballast water had yet to commence, and therefore the level of the potential risk of 

accelerated corrosion to the ballast water piping and structure that may be raised 

by use of this system remains to be assessed. 
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 .12 Based on information provided in the application for Basic approval a PEC/PNEC 

ratio of discharged ballast water in Rotterdam harbor can be calculated to 0.85. 

Based on this ratio the Group concludes that under the conditions of the test there 

would be low risk for the environment. For a final risk assessment to the 

environment the Group needs, however, a better explanation of the presence and 

performance of the algae monitor and information on the validity and applicability 

of the model used. For reference reasons also calculations with the 

MAMPEC-model are recommended using as many as possible the same 

parameter values. 

Under the assumptions of the applicant there seems no risk for the environment 

but the Group needs more confidence in the applied tools and methods. 

.13 During the evaluation process and interactions with the German authorities it 

showed that research on the second treatment procedure was still under testing for 

biological efficacy, influence to the environment and risk on crew and ship. 

_____________