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.

I:\MEPC\58\2-7.doc 

INTERNATIONAL MARITIME ORGANIZATION

IMO 

E

MARINE ENVIRONMENT PROTECTION 

COMMITTEE 

58th session 

Agenda item 2 

MEPC 58/2/7

 14 July 2008

 Original: ENGLISH

HARMFUL AQUATIC ORGANISMS IN BALLAST WATER 

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

Note by the Secretariat 

SUMMARY

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

GESAMP-Ballast Water Working Group (GESAMP-BWWG) and 

includes the evaluation of proposals submitted for approval by Japan, 

the Netherlands and the Republic of Korea 

Strategic direction: 7.1 

High-level action: 7.1.2 

Planned output: 7.1.2.4 

Action to be taken: Paragraph 4 

Related document: GESAMP-BWWG 6/9 (attached) 

Introduction

1 The sixth meeting of the GESAMP-Ballast Water Working Group (GESAMP-BWWG) 

was held at IMO Headquarters from 19 to 23 May 2008 and its report is attached to this 

document as GESAMP-BWWG 6/9. 

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

management systems that make use of Active Substances to treat ballast water prior to discharge 

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

annexes 5 to 7 of the attached report. 

3 Following the adoption of the revised “Procedure for approval of ballast water 

management systems that make use of Active Substances (G9)”, the GESAMP-BWWG 

developed an updated version of the Methodology for information gathering and the conduct of 

its work (the Methodology), as set out at annex 4 of the attached report, to ensure that it 

accurately reflects the provisions of the revised Procedure (G9). 
MEPC 58/2/7 - 2 - 

I:\MEPC\58\2-7.doc 

Action requested of the Committee

4 The Committee is invited to: 

 .1 endorse the updated version of the Methodology contained in annex 4*

 of the 

attached report; 

.2 note the Group’s intention to further develop the Methodology, in particular, on 

the aspect related to Human Exposure Scenario (HES), taking into account 

comments in document BLG 12/5/8 (United States) and the experience of 

other Administrations (paragraph 3.1.3); 

.3 invite interested Administrations to send their comments and suggestions on 

Human Exposure Scenario (HES) to the IMO Secretariat with an understanding 

that they will be disseminated among the members of the Group to facilitate 

the Group’s consideration (paragraph 3.1.4); 

.4 agree to the Group’s clarification on why analytic ballast water toxicity tests 

should be conducted immediately after treatment, at the middle, and at the end of 

the five-day period required in Guidelines (G8) and on how this information 

will be used in the evaluation (paragraphs 3.3.5 and 3.3.6); 

.5 note that after consideration of the logistical costs and timing implication related 

to the proposals contained in document BLG 12/5/10 (Norway), the Group 

identified a number of aspects which did not support the approach proposed 

(paragraphs 3.4.1 and 3.4.2); 

.6 note the Group’s willingness to designate its representatives to attend the 

proposed GloBallast Workshop on ballast water treatment technology test 

facilities, to present the Group’s expectations regarding the testing facilities and 

their procedures and to assist in the development of the relevant Guidance Manual 

(paragraphs 3.4.3 and 3.4.4); 

.7 invite Members to bring Procedure (G9) and the Methodology to the attention 

of concerned Administrations and to advise the applicants to structure their 

applications in accordance with the Methodology (paragraph 5.1.3); 

.8 request Administrations to evaluate the application dossier and confirm that it is 

satisfactory and complete before submitting to the Organization in accordance 

with Procedure (G9), bearing in mind that the Group might not be able to 

complete its evaluation if the data are not complete and presented in a clear and 

concise manner (paragraphs 5.1.4 and 5.1.5); 

.9 agree to the Group’s proposal to develop a database containing toxicological, 

ecotoxicological data and appropriate physical properties for chemical by-products 

produced by most of the systems, and to define one model with the same basic 

parameters when calculating Predicted Environmental Concentrations (PEC) 

(paragraphs 6.2 and 6.4); 

 

* Paragraphs and annexes referred in this section are those of document GESAMP-BWWG 6/9. 
 - 3 - MEPC 58/2/7 

I:\MEPC\58\2-7.doc 

.10 agree that additional time should be allocated to discuss the lessons learned and 

the general aspects related to the evaluation process without the pressure of having 

to review specific submissions (paragraph 7.2); 

 .11 agree that Basic Approval should be granted to the TG Ballastcleaner and 

TG Environmentalguard system submitted by Japan in document MEPC 57/2/8 

(annex 5); 

 .12 agree that Basic Approval should be granted to the Greenship’s Ballast Water 

Management System submitted by the Netherlands in document MEPC 57/2/7 

(annex 6); 

.13 agree that Final Approval should be granted to the Electro-Clean System (ESC) resubmitted by the Republic of Korea in document MEPC 58/2 (annex 7); and 

.14 approve the report in general. 

*** 

I:\MEPC\58\2-7.DOC 

GESAMP-BWWG 

6th session 

Agenda item 9 

GESAMP-BWWG 6/9

 23 May 2008

 Original: ENGLISH

REPORT OF THE SIXTH MEETING OF THE GESAMP-BALLAST WATER 

WORKING GROUP (GESAMP-BWWG) 

Table of Contents 

Section Page Number 

 

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

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

3 OUTCOME OF BLG 12 AND MEPC 57................................................. 4 

4 TERMS OF REFERENCE AND TIME FRAME ............................ 8 

5 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER 

MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE 

SUBSTANCES .......................................................................................... 

9 

6 FURTHER DEVELOPMENT OF THE METHODOLOGY FOR 

INFORMATION GATHERING AND THE CONDUCT OF WORK OF 

THE GESAMP-BWWG ......................................................... 

10 

7 ANY OTHER BUSINESS .................................................... 11 

8 CONSIDERATION AND ADOPTION OF THE REPORT .................. 11 
GESAMP-BWWG 6/9 - 2 - 

I:\MEPC\58\2-7.doc 

ANNEXES 

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

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

Annex 3 Terms of reference for the Technical Group (GESAMP-BWWG) 

Annex 4 The Methodology for information gathering and the conduct of work of the 

GESAMP-BWWG 

Annex 5 Review of proposals for approval of Ballast Water Management Systems that make 

use of Active Substances – TG Ballastcleaner and TG Environmentalguard, 

submitted for Basic Approval by Japan 

Annex 6 Review of proposals for approval of Ballast Water Management Systems that make 

use of Active Substances – A Combined Ballast Water Management System 

Consisting of Sediment Removal and an Electrolytic Process Using Seawater to 

Produce Active Substances, submitted for Basic Approval by the Netherlands 

Annex 7 Review of proposals for approval of Ballast Water Management Systems that make 

use of Active Substances – Electro-Clean System (ECS), submitted for Final 

Approval by the Republic of Korea 
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I:\MEPC\58\2-7.doc 

1 INTRODUCTION 

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

held at IMO Headquarters, London, from 19 to 23 May 2008, under the chairmanship 

of Mr. Jan Linders. 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. D. Pughiuc, Head, Marine Biosafety Section, welcomed members on behalf of 

the Director of the Marine Environment Division, Mr. M. Palomares, and conveyed the 

appreciation of the Secretary-General and the Member States for the work being carried out by 

the Group. 

1.3 Mr. Pughiuc indicated that there was a need to expand the membership of the Group and 

create a pool of experts in order to complete the difficult task of evaluating all of the proposals 

for approval of BWMS that make use of Active Substances in the limited time available between 

two subsequent sessions of MEPC. This task had been made more difficult by the need to have 

additional meetings, which not all members can always attend, as well as having to identify and 

invite members with very specific expertise. The Group was requested to recommend suitable 

experts that could be contacted by the Secretariat/GESAMP in this respect. 

1.4 The Group was informed that, in addition to their task of evaluating three submissions, 

MEPC 57 had raised a number of pertinent issues which the Group was being requested to 

consider. 

2 ISSUES OF CONFIDENTIALITY 

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

submitted by Japan (MEPC 57/2/8) and the Netherlands (MEPC 57/2/7). In addition, 

the Republic of Korea had re-submitted an application for Final Approval (MEPC 58/2). 

Two submissions were supplemented with additional and confidential supporting data, whereas 

the submission from the Netherlands did not provide any confidential information. 

2.2 The confidential nature of the additional data was recognized by the Group and was 

treated as such in order to protect the commercial interests of the manufacturers concerned. 

In order to ensure that the report did not contain any confidential information, the Group noted 

that the Secretariat would liaise with the relevant Administration prior to submitting the report 

to MEPC. 

2.3 Pursuant to paragraphs 4.2.2, 8.1.1 and 8.1.2.7 of the “Procedure for approval of 

ballast water management systems that make use of Active Substances (G9)”, all 

information gathered, materials, notes and reports obtained or made out during the work of 

the GESAMP-BWWG Group, including the report, were, and will be, treated as confidential. 

In this respect all the members of the Group and the Consultant signed the Statements of 

Acceptance related to confidentiality. 

2.4 The original copies of these Statements duly signed and dated by all involved were filed 

with the Technical Secretary of the Group and will be kept together with the submissions. 

2.5 The submissions (dossiers) were deposited in a safe place in IMO Headquarters 

(strong-room) and made available to the Consultant, at his request, during the working hours. 

They were available for consultation by the members of the Group for the duration of the 

meeting in the meeting room and returned to the Organization’s strong-room after the working 

hours. 
GESAMP-BWWG 6/9 - 4 - 

I:\MEPC\58\2-7.doc 

2.6 On completion of the work the Chairman of the GESAMP-BWWG obtained from the 

other members any documents, drafts and any other associated records and reports, which were 

transmitted to the Technical Secretary of the GESAMP-BWWG for retention in confidence. 

All electronic records and data held on personal computers/laptops were destroyed when they 

were no longer necessary for the work of the GESAMP-BWWG. 

3 OUTCOME OF BLG 12 AND MEPC 57 

3.1 Outcome of BLG 12 concerning Human Exposure Scenario 

3.1.1 The Group noted that BLG 12 had continued its work on matters related to 

the Methodology and, in particular, had addressed the aspects related to the Human Exposure 

Scenario (HES), safe handling and storage of chemicals used to treat ballast water and safety 

procedures for the resultant risks to the ships crew from treatment process. The Group noted 

that, having considered document BLG 12/5/8 (United States), BLG 12 had recognized that the 

information used in the technical comments regarding the Human Exposure Assessment (HEA) 

was based mainly on the experience of one country and so had recommended that other national 

regulations should be considered before incorporating the suggested changes in the assessment 

outlined in the GESAMP-BWWG report (MEPC 57/2/10, annex 4). 

3.1.2 It was also noted that BLG 12 had invited Administrations to provide their own 

experiences related to Human Exposure Assessment (HEA), currently being developed 

by GESAMP-BWWG, at their earliest opportunity and had forwarded document BLG 12/5/8 to 

the GESAMP-BWWG for consideration, comment and action. In addition, BLG 12 had 

instructed the Secretariat to explore the possibility of a more direct dialogue on this matter 

between interested Administrations and the GESAMP-BWWG at the earliest possible 

opportunity (BLG 12/17, paragraphs 5.8, 5.11, 5.42.6 and 5.42.7). 

3.1.3 The Group welcomed the comments made by the United States in document BLG 12/5/8 

and assigned two members to liaise directly with the United States to develop its proposals 

further and also take into consideration the experience of other Administrations when such 

information will be made available. 

3.1.4 In order to ensure a more direct dialogue regarding this particular aspect, the Group 

invited interested Administrations to send their comments and suggestions to the IMO Secretariat 

with an understanding that they will be disseminated among the members of the Group as soon as 

possible. 

3.1.5 The Group agreed to identify and reference the suggestions included in the HES for 

consideration by MEPC as appropriate. More text should be prepared on the outcome of the 

Group’s discussion. 

3.1.6 The Group agreed to further develop the HES questionnaire. 
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I:\MEPC\58\2-7.doc 

3.2 Methodology for information gathering and the conduct of work of 

GESAMP-BWWG and related issues 

3.2.1 The Group noted that MEPC 57 adopted the revised “Procedure for approval of 

ballast water management systems that make use of Active Substances (G9)” by 

resolution MEPC.169(57) and requested the GESAMP-BWWG to review its Methodology for 

information gathering and the conduct of work to ensure it accurately reflects the provisions of 

the revised Procedure (G9). Consequently, the Group prepared an updated version of 

the Methodology in light of the revised Procedure (G9), as set out at annex 4 of this report. 

3.2.2 In this connection, the Group noted that MEPC 57 had requested it, in particular, to 

replace the definitions for Basic Approval and Final Approval in the latest version of 

the Methodology with text which refers directly to the revised Procedure (G9). As a result, the 

Group amended the definition for Basic Approval to: 

 “Basic Approval means the preliminary approval of Active Substances and the ballast 

water management system that uses them in order to comply with the Ballast Water 

Management Convention. Basic Approval should confirm that the available information 

does not indicate possible unacceptable adverse effects or a potential for unreasonable 

risk to the environment, human health, property or resources. This should include 

consideration of potential risks associated with the Active Substance during full-scale 

deployment on commercial ships when possible.” 

and Final Approval to: 

 “Final Approval means the approval of a ballast water management system using an 

Active Substance or Preparation to comply with the Convention and includes a review 

of the Type Approval tests in accordance with Guidelines for approval of ballast water 

management systems (G8). The review does not include the re-evaluation of efficacy 

testing results conducted by Administrations under the Guidelines (G8). 

The Final Approval should confirm that previous evaluations of risks to ship, crew and 

the environment including storage, handling and application of Active Substances 

or Preparations remain valid and the concerns expressed during the Basic Approval 

process have been addressed, as well as that the residual toxicity of the discharge 

conforms to the evaluation undertaken for Basic Approval. The risk evaluation at 

Final Approval should take qualitatively into account cumulative effects that may occur 

due to the nature of shipping and port operations. The uncertainties involved in the 

application for approval should be considered during the Final Approval process, and 

advice on how these uncertainties can be dealt with should be provided as appropriate.” 

3.3 Review of the relationship between Procedure (G9) and Guidelines (G8) 

 

3.3.1 The Group recalled that it had previously considered that, if efficacy testing were required 

for two types of water then toxicity testing should be dealt with in a similar manner. It was 

thought that this was particularly important because the various amounts of Dissolved Organic 

Carbon (DOC) and Total Suspended Solids (TSS) could have a marked effect on the quantities of 

by-products produced by the treatment process that, in turn, would affect the toxicity of the 

treated ballast water (MEPC 56/2/2, Report of the third meeting of the GESAMP-BWWG, 

paragraph 5.4.6). 
GESAMP-BWWG 6/9 - 6 - 

I:\MEPC\58\2-7.doc 

3.3.2 In this context, the Group had also recalled that the time-period between treatment 

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

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

reflecting the minimum permitted discharge time, and following an appropriate longer 

interval (MEPC 56/2/2, paragraph 5.4.7). 

3.3.3 The Group recalled further that it had agreed that for ballast water management 

systems that treat the water at the intake, a 5-day lag-time between treatment and discharge 

as recommended by Guidelines (G8) to cover the possible re-growth of organisms is too 

long to allow representative sampling of water for ecotoxicity testing, as toxic chemicals 

will be degraded during the 5 days’ storage period. Consequently, the Group had proposed 

that in the future “whole effluent” ecotoxicity testing and related analytical chemistry of 

exposure conditions should be conducted immediately after treatment and 

after a 24 or 48 hours interval to provide meaningful information regarding the possible 

impact on the receiving environment. Paragraph 10.2.4 of the Methodology was modified 

to reflect this change. (MEPC 57/2/10, report of the fifth meeting of the GESAMP-BWWG, 

paragraph 4.2) 

3.3.4 The Group noted that MEPC 57 considered its concerns expressed in the previous 

meetings, regarding the appropriateness of the discharge toxicity data being submitted from 

the land-based toxicity tests during Type Approval under Guidelines (G8). The Group 

further noted that MEPC 57 requested it to provide additional clarification on why analytic 

ballast water toxicity tests should be conducted immediately after treatment, at the middle, 

and at the end of the five-day period required in Guidelines (G8) and as to how this 

information will be used in the evaluation. 

3.3.5 In considering this issue further, the Group agreed that: 

 .1 levels of chemical by-products produced by a system could vary with time 

following treatment of ballast water. e.g., the levels of all halomethanes, 

haloacetic acids and chloroamines might be expected to rise initially, if 

residual TROs were present, but then might decline later due to 

degradation/evaporation etc; 

 .2 such variation could also occur below the levels of analytical detection with 

unpredictable environmental effects; 

 .3 whilst full chronic aquatic toxicity testing of treated ballast water at various times 

following treatment would provide definitive data, such an approach would be 

expensive, time consuming and complex to perform; and 

 .4 sampling for whole effluent ecotoxicity testing and related analytical chemistry 

conducted prior to the completion of the five day storage period, specified in 

Procedure (G8) and recommended by the Group in paragraph 3.3.3 of this report, 

should only apply to systems which do not include either a neutralization or 

treatment step upon discharge. However, in cases where a neutralization step 

forms an integral part of the treatment system, it should be demonstrated that this 

step is capable of effectively neutralizing all levels of Active Substances which 

might be encountered in the system. 
 - 7 - GESAMP-BWWG 6/9 

I:\MEPC\58\2-7.doc 

3.3.6 Having taken these aspects into account the Group agreed that, in addition to the testing 

required by paragraphs 5.2.2, 5.2.3 and 5.2.4 of Procedure (G9), from a pragmatic standpoint, the 

following information would provide adequate safeguards for the environment: 

 .1 acute toxicity testing using fish, invertebrates and plants; or 

 .2 chemical analysis demonstrating that there is no significant negative changes 

during the five day tank holding time in the chemical by-products; or 

 .3 both chemical analysis and acute aquatic toxicity testing; 

immediately after treatment and after 24 or 48 hours. 

3.4 Logistical costs and timing implication of the proposal by Norway (BLG 12/5/10) for 

screening of ballast water treatment systems

3.4.1 After considering the proposals contained in document BLG 12/5/10 (Norway), the 

Group identified a number of aspects that did not support such an approach including: 

 .1 the Group noted that MEPC had already agreed that it would be for each 

Administration to decide whether a ballast water management system requires 

Active Substances approval or not; 

 .2 the Group and GESAMP itself have only advisory roles and should not liaise 

directly with the Administrations with regard to regulatory aspects which are the 

prerogatives of MEPC; 

 .3 the Group is an ad hoc body and has neither the administrative infrastructure nor 

the ability to meet at a short notice, whenever a request for screening is forwarded 

by an administration; 

 .4 the Group agreed that conducting the ‘screening of applications’ during its regular 

meetings, as a pre-requisite for evaluations in accordance with Procedure (G9) 

or Guidelines (G8), would add to the already overwhelming workload, delay the 

availability of the ballast water technologies and impact on the timely entry into 

force of the BWM Convention; 

 .5 notwithstanding this observation, the Group agreed to contribute to the 

development of specific guidance for the Administrations to ensure a uniform and 

rigorous assessment of all the proposed technologies should MEPC decide to 

develop such a guidance document. Furthermore, it was noted that paragraph 3.3 

of the Revised Procedure (G9) indicates that: 

 “any system which makes use of, or generates, Active Substances, 

Relevant Chemicals or free radicals during the treatment process to 

eliminate organisms in order to comply with the Convention should be 

subject to this Procedure.” 
GESAMP-BWWG 6/9 - 8 - 

I:\MEPC\58\2-7.doc 

.5.1 as a result, the Group believed that the inclusion of Relevant Chemicals and free 

radicals may address, to large extent, the concerns expressed by Norway regarding 

whether a ballast water management system requires Active Substances approval; 

 .6 with regard to the suggested ‘pre-evaluation’ of the testing programmes and 

testing facilities, the Group was of the view that, in addition to the difficulties 

identified in the paragraphs above, such a task would probably go beyond its area 

of expertise. The Group noted that there are well established organizations 

specialized in the evaluation and certification of the QMPs and QAPPs of the 

entities that may undertake type approval activities on behalf of the 

Administrations and that such organizations are, in most of the cases, recognized 

by the ISO. 

3.4.2 Notwithstanding the above-mentioned considerations, should MEPC be of the view 

that GESAMP-BWWG is the most appropriate body to perform the tasks indicated in 

document BLG 12/5/10, the Group would be prepared to accept the additional responsibilities 

provided that it will work only during its regular meetings and the resources will be increased to 

allow the assignment of additional experts to achieve a better division of the tasks. 

3.4.3 The Group noted that the GloBallast Programme has among its strategic objectives the 

development of a "Guidance Manual for Ballast Water Treatment Technology Test Facility” 

including recommended QMPs and QAPPs for testing procedures and is currently considering 

the possibility of organizing a workshop to address this issue. Such a workshop would: 

 .1 provide a forum for technology test facility developers, treatment technology 

developers, administrations and other interested parties to initiate a dialogue on 

the various aspects of this specific matter; 

 .2 facilitate the development of a manual that could be made widely available to 

interested stakeholders; and 

 .3 contribute to the establishment of a global network of test facilities that will 

promote continuous information exchange and experience sharing. 

3.4.4 The Group recognized that the GloBallast approach proposed may be an appropriate 

means of addressing this issue and agreed that it would contribute to this process by designating 

its representatives to attend the workshop, present the GESAMP-BWWG expectations regarding 

the testing facilities and procedures and assist in the development of the Guidance Manual if 

requested. 

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 used the table agreed at MEPC 56 and reproduced below to determine the 

timetable for activities related to its regular meetings and agreed to decide, on a case-by-case 

basis, on the timing of additional meetings as appropriate. 
 - 9 - GESAMP-BWWG 6/9 

I:\MEPC\58\2-7.doc 

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 

4.3 The Group noted that MEPC 59 will be held from 6 to 10 July 2009 and, using the above 

timetable, agreed that the deadline for submission of application dossiers and related documents 

for consideration by MEPC 59 should be 19 December 2008. 

4.4 The Group reconfirmed that its next meeting will take place from 30 June to 4 July 2008 

to review the remaining three proposals received before the deadline of 21 July 2008 and agreed 

to tentatively schedule its 8th meeting from 16 to 20 February 2009 subject to the submission of 

the application dossiers in accordance with the deadline agreed in paragraph 4.3 above. 

5 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER 

MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES 

5.1 General review of the submissions 

5.1.1 The Group noted that submissions for Basic Approval had been received from Japan 

and the Netherlands whilst a re-submission for Final Approval had been received from 

the Republic of Korea. 

5.1.2 Once again, the Group noted that some submissions had not been presented in the clear 

and concise manner required to allow it to evaluate the applicant’s system in an efficient manner. 

As a result, the Group found it necessary to ask for a lot of clarifications from some of the 

applicants and, as a result, was evaluating their responses as late as Friday of the meeting. It was 

considered that this hindered the efficient working practice of the Group. 

5.1.3 As a result, the Group requested MEPC to urge applicants and concerned Administrations 

to note the Methodology and the requirements of Procedure (G9) so that they may construct their 

applications in an appropriate format before the submission. 

5.1.4 The Group recalled that the Administration is expected to review any application prior to 

its submission to IMO (G9 8.1.2.3). However, the Group noted that some of the applications had 

neither a complete dataset nor test results with adequate Quality Control and Quality Assurance. 

As a result, the Group requested to MEPC to urge Administration to recall their position and 

tasks under Procedure (G9) and to manage the application accordingly. 
GESAMP-BWWG 6/9 - 10 - 

I:\MEPC\58\2-7.doc 

5.1.5 In addition, MEPC was requested to convey to future applicants that the Group might not 

be able to complete its evaluation if the data are not complete and presented in a clear and 

concise manner. 

5.2 Detailed review of the submissions 

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

 .1 Annex 5 Review of the ballast water management system using 

“TG Ballastcleaner and TG Environmentalguard” as 

Active Substances, submitted by Japan; 

 .2 Annex 6 Review of a combined ballast water management system consisting 

of sediment removal and an electrolytic process using seawater to 

produce Active Substances (Greenship Ltd), submitted for 

Basic Approval by the Netherlands; and 

 .3 Annex 7 Review of the ballast water management system using 

Active Substance (Electro-Clean Electrolytic Disinfection), 

submitted by the Republic of Korea. 

5.2.2 Having reviewed all of the information associated with the submissions, the Group 

recommended that: 

 .1 Basic Approval be granted to the “TG Ballastcleaner and 

TG Environmentalguard” system submitted by Japan; 

 .2 Basic Approval be granted to the Greenship Ltd system submitted by 

the Netherlands; and 

 .3 Final Approval be granted to the Electro-Clean system submitted by 

the Republic of Korea. 

6 FURTHER DEVELOPMENT OF THE METHODOLOGY FOR INFORMATION 

GATHERING AND CONDUCT OF THE WORK 

6.1 Having considered a number of submissions during the course of the first five meetings, 

the Group recognized that most of the systems tended to produce the same chemical by-products 

in the treated ballast water. 

6.2 As a result, the Group agreed that it would facilitate both the reporting and evaluation of 

systems if the toxicological, ecotoxicological data and appropriate physical properties for such 

chemicals were collected into a database and made available to all IMO Member States. 

6.3 It was recognized that such an approach would allow the Predicted No Effect 

Concentrations (PNEC) of these chemicals to be used by all applicants, which would provide a 

consistent approach. 

6.4 In addition, the Group recognized that the calculation of Predicted Environmental 

Concentrations (PEC) for those chemical by-products generated by the various systems have 

been generated by different models or by one model using different input parameters. In order to 

have a uniform approach to the generation of PECs, the Group agreed that it would be preferable 

to use one model with the same basic parameters in order to make comparisons of the results 

more meaningful. 
 - 11 - GESAMP-BWWG 6/9 

I:\MEPC\58\2-7.doc 

6.5 Notwithstanding these observations, the Group recognized that each applicant would still 

be required to provide full chemical analysis of the chemicals produced in the ballast. 

6.6 It was also agreed that full mammalian toxicity data profiles for all of these chemicals 

would also be provided where data were available. 

6.7 As a result, the Group requested MEPC to agree that this approach would facilitate the 

evaluation process and instruct the Secretariat to generate such a database. 

7 ANY OTHER BUSINESS 

7.1 Having considered several general issues that resulted from the review of the three 

specific applications for approval of ballast water management systems, the Group recognized 

the need to have time to consider more general aspects of the process. 

7.2 As a result, the Group requested MEPC to agree that the Group should meet for two days 

in order to have the time to discuss such issues without the pressure of having to review specific 

submissions. 

8 CONSIDERATION AND ADOPTION OF THE REPORT 

8.1 A draft report of the 6th meeting of the GESAMP-BWWG was produced 

on 23 May 2008, 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. 

8.2 In his closing remarks, Mr. M Palomares, Director, Marine Environment Division, 

acknowledged the hard work of the Group and congratulated its members for the results 

achieved. He also appreciated the work done on the Methodology for information gathering 

and conduct of work of the GESAMP-BWWG indicating that the Methodology will be 

disseminated as an IMO technical circular. With regard to the toxicity and hazards database 

proposed by the Group, Mr. Palomares informed that all the possibilities for developing such a 

tool will be explored and further advice will be sought from the Committee on this particular 

matter. A detailed briefing on the outcome of the recent annual meeting of GESAMP was 

provided by Mr. Palomares in his concluding remarks when he emphasized the need to expand 

the membership of the Group and to create a pool of experts to call upon as and when required. 

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

by the members of the Group throughout the week and closed the meeting at 17 h 30. 

***

GESAMP-BWWG 6/9 

I:\MEPC\58\2-7.DOC 

ANNEX 1 

LIST OF MEMBERS WHO ATTENDED THE SIXTH SESSION 

OF THE GESAMP-BWWG 

Mr. Jan Linders (Chairman) 

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 

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 

1-15-16 Toranomon 

Minato-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 6/9 

ANNEX 1 

Page 2 

I:\MEPC\58\2-7.doc 

Dr. Brigitte Behrends 

Marine Environment Chemist 

Marena Ltd. 

St. Annenstr. 27 

Jever 

D-26441 

Germany 

E-mail: 

Tel: 

Mobile: 

brigitte.behrends@belugagroup.com 

+49 (0) 4461 984 098 

+49 (0) 16 2244 3484 

Mr. Edward Lemieux 

Section Head, Corrosion Engineering, Code 

6136 

Centre for Corrosion Science & Engineering 

Naval Research Laboratory 

Key West, Florida 

USA 

E-mail: 

Tel: 

Fax: 

Mobile: 

edward.lemieux@nrl.navy.mil 

+1-305-293-4214 

+1-305-293-4217 

+1-240-475-6918 

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 

 

Mr. John Crayford 

2 Dunmow Hill 

Fleet 

Hampshire 

GU51 3AN 

United Kingdom 

E-mail: 

Tel: 

Mobile: 

j.crayford@ntlworld.com 

+44 (0)1252 672245 

+44 (0)795 0894 244 

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 6/9 

ANNEX 1 

Page 3 

I:\MEPC\58\2-7.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. René Coenen 

IMO Technical Secretary to GESAMP 

Marine Environment Division 

International Maritime Organization 

4 Albert Embankment 

London SE1 7SR 

United Kingdom 

E-mail: 

Tel: 

Fax: 

rcoenen@imo.org

+44 (0)20 7587 3239 (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 6/9 

I:\MEPC\58\2-7.DOC 

ANNEX 2 

AGENDA FOR THE SIXTH SESSION 

OF THE GESAMP-BALLAST WATER WORKING GROUP 

1 Introduction 

2 Issues of confidentiality 

3 Outcome of MEPC 57 and BLG 12 

4 Terms of reference and time frame 

5 Review of proposals for approval of Active Substances 

6 Further development of the Methodology for information gathering and 

conduct of work 

7 Any other business 

8 Consideration and adoption of the report 

*** 

GESAMP-BWWG 6/9 

I:\MEPC\58\2-7.DOC 

ANNEX 3 

TERMS OF REFERENCE FOR THE TECHNICAL GROUP 

(GESAMP-BWWG) 

1 Consideration of development of necessary methodologies and information requirements 

in accordance with G9∗ for consideration by MEPC 58. 

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 should 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 the Procedure for approval of ballast water management systems that make use 

of Active Substances (G9), adopted by resolution MEPC.126(53). 

GESAMP-BWWG 6/9 

I:\MEPC\58\2-7.DOC 

ANNEX 4 

METHODOLOGY FOR INFORMATION GATHERING AND THE 

CONDUCT OF WORK OF GESAMP-BWWG 

(Updated 23 May 2008) 

Page

1 INTRODUCTION................................................................................................... 4

1.1 Terms and definitions.............................................................................. 4

1.2 Abbreviations used in the text................................................................. 5

 

2 GENERAL............................................................................................................... 7

 2.1 Legal provision......................................................................................... 7

 2.2 Principles of acceptability of BWMS that make use of Active 

Substances..................................................................................................... 7

 2.3 Submission of an application for Basic Approval................................. 7

 2.4 Confidentiality and data protection........................................................ 8

 2.5 Test methods............................................................................................. 9

 2.6 Alternatives to testing and non-submission of data................................. 10

 2.7 Additional Data ....................................................................................... 10

 

3 APPLICATION DATA SET ................................................................................. 10

3.1 General ............................................................................ 10

3.2 Identification of the Substance or Preparation (G9: 4.1).................... 11

3.2.1 Preparations.................................................................................. 11

3.2.2 Active Substances............................................................................ 11

3.2.3 Relevant Chemicals (G9: 2.1.4).................................................. 12

3.2.4 Other Chemicals........................................................................... 12

3.3 Data on effects on aquatic plants, invertebrates and fish, and 

other biota, including sensitive and representative organisms 

(G9: 4.2.1.1).............................................................................................. 12

3.3.2 Acute aquatic toxicity................................................................... 12

3.3.3 Chronic aquatic toxicity............................................................... 13

3.3.4 Endocrine disruption................................................................... 13

3.3.5 Sediment toxicity.......................................................................... 13

3.3.6 Bioavailability/biomagnification/bioconcentration................... 14

3.3.7 Food web/population effects........................................................ 14

3.4 Data on mammalian toxicity (G9: 4.2.1.2)............................................ 15

3.4.1 

3.4.2 

General.................................................................... 

Acute toxicity................................................................................ 

15

15

3.4.3 Effects on skin and eye................................................................. 15

3.4.4 Repeated-dose toxicity................................................................. 16

3.4.5 Chronic toxicity............................................................................ 16

3.4.6 Developmental and reproductive toxicity.................................. 17

3.4.7 Carcinogenicity............................................................................. 17

3.4.8 Mutagenicity/genotoxicity........................................................... 17

3.4.9 Toxicokinetics............................................................................... 18
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I:\MEPC\58\2-7.doc 

3.5 Data on environmental fate and effect under aerobic and 

anaerobic conditions (G9: 4.2.1.3)......................................................... 18

3.5.1 

3.5.2 

General.................................................................... 

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

18

18

3.5.3 Bioaccumulation, partition coefficient, octanol/water partition 

coefficient.......................................................................................... 19

3.5.4 Persistence and identification of the main metabolites in the 

relevant media (ballast water, marine and fresh waters)......... 20

3.5.5 Reaction with organic matter...................................................... 20

3.5.6 Potential physical effects on wildlife and benthic habitats....... 20

3.5.7 Potential residues in seafood....................................................... 21

3.5.8 Any known interactive effects..................................................... 21

3.6 Physical and chemical properties for the Active Substances and 

preparations and treated ballast water, if applicable (G9: 4.2.1.4).... 21

3.6.2 Melting point................................................................................. 21

3.6.3 Boiling point.................................................................................. 21

3.6.4 Flammability (flash point)........................................................... 21

3.6.5 Density (relative density)............................................................. 22

3.6.6 Vapour pressure, vapour density................................................ 22

3.6.7 Water solubility/dissociation constant........................................ 22

3.6.8 Oxidation/reduction potential..................................................... 22

3.6.9 Corrosivity to the materials or equipment of normal ship 

construction................................................................................... 22

3.6.10 Auto-ignition temperature........................................................... 22

3.6.11 Explosive properties..................................................................... 23

3.6.12 Oxidizing properties..................................................................... 23

3.6.13 Surface tension.............................................................................. 23

3.6.14 Viscosity......................................................................................... 23

3.6.15 Thermal stability and identity of relevant breakdown 

products......................................................................................... 23

3.6.16 Reactivity towards container material....................................... 23

3.6.17 pH................................................................................................... 23

3.6.18 Salinity........................................................................................... 23

3.6.19 TOC, DOC, % particulate matter.............................................. 24

3.6.20 Other known relevant physical or chemical hazards................ 24

3.7 Analytical methods at environmentally relevant concentrations 

(G9: 4.2.1.5).......................................................................................................... 24

4 USE OF THE ACTIVE SUBSTANCE OR THE PREPARATION................... 24

4.1 The manner of application...................................................................... 24

5 MATERIAL SAFETY DATA SHEETS (G9: 4.2.7)........................................... 25

6 RISK CHARACTERIZATION............................................................................. 25

6.1 Screening for persistence, bioaccumulation and toxicity 

(G9: 5.1).................................................................................................... 25

6.1.1 Persistence (G9: 5.1.1.1).............................................................. 25

6.1.2 Bioaccumulation (G9: 5.1.1.2).................................................... 26

6.1.3 Toxicity tests (G9: 5.1.2.3).......................................................... 26
GESAMP-BWWG 6/9 

ANNEX 4 

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I:\MEPC\58\2-7.doc 

6.1.4 Does the Active Substance and/or preparation meet all 

three criteria for PBT?................................................................ 26

6.2 Evaluation of the treated ballast water (G9: 5.2)................................. 26

6.2.1 Basic Approval.............................................................................. 27

6.2.2 Final Approval.............................................................................. 27

6.2.3 Determination of holding time.................................................... 27

6.3 Risk characterization and analysis......................................................... 27

6.3.1 Reaction with organic matter 

(see G9: 4.2.1.3; this report 3.5.5).............................................. 27

6.3.2 Characterization of degradation route and rate (G9: 5.3.5)... 27

6.3.3 Prediction of discharge and environmental concentrations..... 27

6.3.4 Assessment of potential for bioaccumulation............................ 28

6.3.5 Effects assessment........................................................................ 28

6.3.6 Effects on aquatic organisms....................................................... 28

6.3.7 Effects on sediment....................................................................... 29

6.3.8 Comparison of effect assessment with discharge toxicity......... 30

7 RISK ASSESSMENT.............................................................................................. 30

7.1 Risk to safety of ship................................................................................ 30

7.2 Risks to human health.............................................................................. 30

7.2.2 Health effects in humans............................................... 31

7.2.3 Human Exposure Scenario............................................ 31

7.3 Risks to the aquatic environment........................................................... 32

8 ASSESSMENT REPORT (G9: 4.3)...................................................................... 32

9 MODIFICATION TO THE APPLICATION...................................................... 33

10 FINAL APPROVAL............................................................................................... 33

APPENDIX 1 – KEY DATA SUMMARY FORM FOR GESAMP- BWWG 

TECHNICAL EVALUATION OF BALLAST WATER 

MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE 

SUBSTANCES TO COMPLY WITH THE CONVENTION....... 35

APPENDIX 2 – HUMAN EXPOSURE ASSESSMENT................................... 41
GESAMP-BWWG 6/9 

ANNEX 4 

Page 4 

I:\MEPC\58\2-7.doc 

1 INTRODUCTION

This document contains the Methodology for information gathering and the conduct of work of 

the GESAMP-BWWG when undertaking technical evaluations in accordance with the 

“Procedure for the approval of ballast water management systems that make use of 

Active Substances (G9)”, as revised (adopted by resolution MEPC.169(57)). 

1.1 Terms and definitions 

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

Water Management Convention to facilitate a consistent evaluation of submissions: 

.1 Ballast Water Management Convention means the International Convention for 

the Control and Management of Ships’ Ballast Water and Sediments, 2004. 

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

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

harmless, or avoid the uptake or discharge of harmful aquatic organisms and 

pathogens within ballast water and sediments. 

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

Substances including any additives. This term also includes any Active 

Substances generated on board for purposes of ballast water management and any 

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

of Active Substances to comply with the Convention. 

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

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

pathogens. 

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

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

treatment of ballast water. 

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

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

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

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

.7 Basic Approval means the preliminary approval of Active Substances and the 

ballast water management system that uses them in order to comply with the 

Ballast Water Management Convention. Basic Approval should confirm that the 

available information does not indicate possible unacceptable adverse effects or a 

potential for unreasonable risk to environment, human health, property or 

resources. This should include consideration of potential risks associated with the 

Active Substance during full-scale deployment on commercial ships when 

possible. 
GESAMP-BWWG 6/9 

ANNEX 4 

Page 5 

I:\MEPC\58\2-7.doc 

.8 Final Approval means the approval of a ballast water management system using 

an Active Substance or Preparation to comply with the Convention and includes a 

review of the Type Approval tests in accordance with Guidelines for approval of 

ballast water management systems (G8). The review does not include the 

re-evaluation of efficacy testing results conducted by Administrations under the 

Guidelines (G8). The Final Approval should confirm that previous evaluations of 

risks to ship, crew and the environment including storage, handling and 

application of Active Substances or Preparations remain valid and the concerns 

expressed during the Basic Approval process have been addressed, as well as that 

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

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

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

port operations. The uncertainties involved in the application for approval should 

be considered during the Final Approval process, and advice on how these 

uncertainties can be dealt with should be provided as appropriate. 

.9 GESAMP–Ballast Water Working Group (GESAMP-BWWG) means the 

Technical Group consisting of independent experts acting in their individual 

capacity that review the proposals for approval of ballast water management 

systems that make use of Active Substances submitted by the Administration and 

report, through GESAMP, to MEPC. When reviewing the proposals the Group 

should take account of any other relevant data as well as other relevant information 

submitted to it. 

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

Joint Group of Experts on the Scientific Aspects of Marine Environmental 

Protection, an advisory and multi-disciplinary body consisting of specialized 

experts nominated by the sponsoring agencies. Experts working for GESAMP act 

independently in their individual capacity. 

1.2 Abbreviations used in the text 

ABBREVIATIONS 

< less than 

< less than or equal to 

> greater than 

> greater than or equal to 

μg Microgram 

 

b.p. boiling point 

Bw body weight 

BWMS ballast water management system 

 

°C degree Celsius (Centigrade) 

CAS Chemical Abstract Service 

Cc cubic centimetre 

 

D day(s) 

DOC dissolved organic carbon 
GESAMP-BWWG 6/9 

ANNEX 4 

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I:\MEPC\58\2-7.doc 

EC50 effect concentration, 50% (median effective concentration) 

 

G gram 

GHS Globally Harmonized System 

G9 Procedure for approval of ballast water management 

systems that make use of Active Substances (G9), as revised, 

adopted by resolution MEPC.169(57) in April 2008. 

h hour 

 

IARC International Agency for Research on Cancer 

IC50 inhibition concentration, 50% 

ISO International Organization for Standardization 

IUPAC International Union of Pure and Applied Chemistry 

 

Kg kilogram 

Koc organic carbon-water partition coefficient 

 

L litre 

LC50 lethal concentration, 50% 

LD50 lethal dose, 50% 

LOAEL lowest observed adverse effect level 

LDLO lowest lethal dose 

LOEL lowest observed effect level 

Log P logarithm of the octanol/water partition coefficient 

 

MEPC Marine Environment Protection Committee 

m.p. melting point 

Mg milligram 

Ml millilitre 

 

Ng nanogram 

NOAEL No-observed-adverse-effect level 

NOEL No-observed-effect level 

 

OECD Organization for Economic Co-operation and Development 

Organization the International Maritime Organization 

POC particulate organic carbon 

Pow Octanol/water partition coefficient 

 

TLV threshold limit value 

US EPA United States Environmental Protection Agency 

 

WHO World Health Organization 

 

Wt weight 
GESAMP-BWWG 6/9 

ANNEX 4 

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I:\MEPC\58\2-7.doc 

2 GENERAL 

2.1 Legal provision 

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

Ships’ Ballast Water and Sediments, 2004, stipulates that ballast water management systems 

(BWMS) that make use of Active Substances to comply with the Convention shall be approved 

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

Committee (MEPC) adopted the “Procedure for approval of ballast water management systems 

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

Resolution MEPC.169(57) revoked the initial Procedure and provided a revised version of it. 

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

2.2.1 A ballast water management system that makes use of Active Substances accomplishes its 

intended purpose through action on harmful aquatic organisms and pathogens in ships’ ballast 

water and sediments. However, if the ballast water is still toxic at the time of discharge into the 

environment, the organisms in the receiving water may suffer unacceptable harm. Both the 

Active Substance itself or Preparation, as well as the treated ballast water, should be subjected to 

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

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

acceptably low (G9: 3.2). 

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

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

Convention should be subject to Procedure (G9) (G9: 3.3). 

2.2.3 Ballast water management systems that make use of Active Substances and Preparations 

must be safe in terms of the ship, its equipment and the personnel to comply with the Convention 

(G9: 3.4). 

2.3 Submission of an application for Basic Approval

2.3.1 The manufacturer of the ballast water management system should evaluate the Active 

Substance(s) or Preparation(s) and the potential discharge of treated ballast water in accordance 

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

should prepare an application dossier for the ballast water management system that makes use of 

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

Organization. An application should only be made once the ballast water management system, 

Active Substance or Preparation has been sufficiently designed, progressed and tested to provide 

the full data necessary for a Basic Approval (G9: 8.1.2.2). 

2.3.2 The Administration should evaluate the application dossier and confirm that it is 

satisfactory and complete before submitting it to IMO. Administrations should check the quality 

and completeness of any Basic or Final Approval submission, against the latest version of the 

Methodology for information gathering and the conduct work of the Technical Group agreed by 

the Organization, prior to its submission to the MEPC (G9: 3.6). 
GESAMP-BWWG 6/9 

ANNEX 4 

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I:\MEPC\58\2-7.doc 

2.3.3 Applications for Basic Approval of the ballast water management system, associated 

with Active Substances, to be evaluated by the GESAMP-BWWG should be addressed to: 

Marine Environment Division, International Maritime Organization, 4 Albert Embankment, 

London SE1 7SR, United Kingdom. 

2.3.4 Application contents: 

.1 a complete application dossier including all documents identified in this paragraph 

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

The complete application dossier should contain a contents list indicating the 

location of the information in the application. The order in which the information 

is presented, including overall structure such as how information is presented for 

the Active Substance, preparation, ballast water, risk assessment, assessment 

report, should follow this format, including its numbering, which is based on 

Procedure (G9); 

.2 a non-confidential summary document, which would be circulated as an MEPC 

document to provide an overview of the application (electronic version); 

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

(electronic version); 

.4 the assessment report (electronic version); and 

.5 dossiers already used for registration of chemicals can be used to satisfy the data 

provisions of Procedure (G9) (G9: 4.2.5). 

2.4 Confidentiality and data protection

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

All information related to safety and environmental protection, including physical/chemical 

properties, environmental fate and toxicity, should be treated as non-confidential (G9: 8.1.1). 

Once an approval procedure is completed and the system using the Active Substance is approved, 

the following data should not be regarded as confidential: 

 .1 the name and address of the Administration; 

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

preparation (if different); 

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

of the preparation; 

.4 the names of other components of preparations, in particular those that are 

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

contribute to the hazard documentation of the preparation; 

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

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

health; 
GESAMP-BWWG 6/9 

ANNEX 4 

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I:\MEPC\58\2-7.doc 

.5.1 the names of other chemicals that may be formed during or after the 

application of the BWMS with a technical justification for why they 

should not be treated as Relevant Chemicals; 

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

its components and Relevant Chemicals; 

.7 a summary of the results of the tests conducted pursuant to section 4.2 of the 

Procedure (G9) to establish the effects of the substance(s) or preparation(s) on 

humans and the environment; 

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

pursuant to section 5.2 of Procedure (G9); 

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

storage, transport and fire; 

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

.11 Safety Data Sheets; 

.12 methods of chemical analysis; 

 .13 methods of disposal of the product and of its packaging; 

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

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

.16 all results of the Persistence, Bioaccumulation and Toxic (PBT) assessment and 

the risk characterization pursuant to sections 5.1 and 5.3 of Procedure (G9); and 

 .17 the uncertainty analysis specified in paragraph 6.4.3 of Procedure (G9). 

2.5 Test methods

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

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

system (G9: 4.2.4) (e.g., Good Laboratory Practice (GLP)). Information may be derived from 

existing data where an acceptable justification is provided. Full copies of sources of data (e.g., 

literature papers) should be provided. 

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

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

information, it may not be possible for the GESAMP-BWWG to conduct a thorough risk 

assessment. 

2.5.3 Many substances have acquired large databases for many of the hazards concerned and a 

weight of evidence approach has become necessary to ensure that the rating reflects the body of 

data rather than simply using the most conservative value. This, however, means the submission 

of all available end-point data for Active Substances and Relevant Chemicals is necessary to 

enable a thorough review. 
GESAMP-BWWG 6/9 

ANNEX 4 

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I:\MEPC\58\2-7.doc 

2.5.4 A list of test substances (for example, trade names) specified in study reports and 

literature data and an explanation of how the tested substances relate to the current application 

should be provided. 

2.6 Alternatives to testing and non-submission of data

2.6.1 Alternative methods to testing on live organisms, e.g., in vitro testing methods, 

Quantitative structure-activity relationship (QSAR), extrapolation by analogy to known 

chemicals, or grouping of similar substances, may be used whenever justified. 

Sufficient documentation or references to documentation on the validity of the method should be 

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

domain of the method. 

2.6.2 Information that is not necessary, owing to the nature of the substance or of its proposed 

uses and taking into account all proposed risk management measures, need not be supplied. 

The same applies where it is not scientifically necessary or technically possible to supply the 

information. In such cases, a justification should be submitted, which would help the 

GESAMP BWWG’s evaluation of the application dossier. 

2.7 Additional data 

2.7.1 If, in the course of the review by the GESAMP-BWWG, it becomes evident that 

additional data are found to be necessary in order to finalize the evaluation, the Group may 

request that such data are submitted. 

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

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

3.0 APPLICATION DATA SET 

3.1 General 

3.1.1 The dossier should contain the information specified in Procedure (G9). In cases where 

information requested in accordance with Procedure (G9) has not been submitted and no 

justification for non-submission is provided, the GESAMP-BWWG may not be able to judge the 

reasons for not submitting the information that may influence its evaluation and development of 

recommendations. 

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

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

provided as well. 

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

Preparations (G9: 5.3.1). However, the GESAMP-BWWG notes that normally assessment of 

fate (including degradation, bioaccumulation) is not feasible for preparations, but only for 

individual substances. Therefore, degradation and fate testing of Preparations may not be 

appropriate. 

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

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

part of the land-based type approval process with test species (fish, invertebrate, algae) that address 

the sensitive life stage (G9: 5.2.4). The results should include acute LC50 values and 
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chronic NOECs (G9: 5.2.5). Therefore, 100% concentrations of samples of ballast water 

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

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

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

internationally recognized test method may also be used as well. 

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

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

information (G9: 4.2.2): 

 .1 the Trade name; 

 .2 compositional information of the Preparation including: 

 .1 the chemical (IUPAC) name of each component; 

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

in %v/v); 

 .3 the CAS number of each component; 

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

(where relevant); and 

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

stabilizer or inhibitor or solvent, etc. 

3.2.2 Active Substances: For each Active Substance, the applicant should provide the 

following information: 

 .1 the Trade name (where relevant); 

 .2 the chemical (IUPAC) name; 

 .3 the CAS number; 

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

 .5 the Molar mass; 

 .6 the empirical formula; 

 .7 the structural formula; 

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

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

and CAS-numbers, etc.); and 

 .10 the identity of any stabilizers or necessary additives. 
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3.2.3 Relevant Chemicals (G9: 2.1.4): Where the process might produce by-products when 

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

products deemed to be Relevant Chemicals: 

 .1 the Chemical (IUPAC) name; 

 .2 the CAS number; 

 .3 the Molar mass; 

 .4 the empirical formula; 

.5 the structural formula; and 

 .6 the classification in accordance with the GHS system. 

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

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

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

sensitive and representative organisms (G9: 4.2.1.1) 

3.3.1 For every Active Substance or Preparation including any of its components, data should 

be presented and discussed either on the basis of toxicological tests or existing toxicological 

knowledge for each end point listed. 

3.3.2 Acute aquatic toxicity

3.3.2.1 Short-term L(E)Cx from freshwater or saltwater representatives of 

three taxonomic groups (algae, crustaceans and fish) representing three trophic levels 

(e.g., OECD guidelines 201 (Algae, Growth Inhibition Test), 202 (Daphnia sp. Acute Immobilization 

Test), 203 (Fish, Acute Toxicity Test), Mysid shrimp acute toxicity test 

(USEPA 850.1035) should be accepted. To reduce further any remaining uncertainty, 

Administrations should, preferably, also submit data for two additional marine taxonomic groups 

(e.g., echinoderms, molluscs). 

3.3.2.2 In the case of whole effluent testing, US EPA or equivalent, short-term methods for 

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

3.3.2.3 Such acute aquatic toxicity data should be provided for: 

.1 Preparations including any of its components; 

.2 Active Substances; 

.3 Relevant Chemicals; and 

.4 Treated ballast water (G9: 5.2.3). 
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3.3.3 Chronic aquatic toxicity

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

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

or 212; Daphnia: OECD 211). To reduce further any remaining uncertainty, Administrations 

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

(e.g., echinoderms, molluscs). 

3.3.3.2 In case of whole effluent testing, US EPA short-term methods for estimating the chronic 

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

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

3.3.3.3 Such chronic aquatic toxicity data should be provided for: 

.1 Preparations including any of its components; 

.2 Active Substances; 

.3 Relevant Chemicals; and 

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

3.3.4 Endocrine disruption

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

as in vitro tests may be conducted as long as no internationally standardized tests are available 

(e.g., full-life-cycle test on fish or amphibian metamorphosis assay). When substantial evidence 

on such effects is available, this should be taken into account on a case-by-case basis and in the 

effect assessment for each compartment of relevance. If there is no indication for endocrine 

disruption – e.g., due to the structure of the substance or results of other available studies – these 

tests may be waived. 

3.3.4.2 Such information on endocrine disruption should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.3.5 Sediment toxicity

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

significant extent should be assessed for toxicity to sediment-dwelling organisms. Testing is 

considered relevant only if log Kow > 3 or if there is similar adsorption behaviour and should 

include a maximum of three long-term tests with species representing different living and feeding 

conditions (e.g., Chironomus spec. (OECD 218), Lumbriculus variegates) including a minimum 

of two tests with marine species. 

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

specific marine sediment assessment is necessary. 
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3.3.5.3 Such information on sediment toxicity should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; 

 .3 Relevant Chemicals; and 

.4 Treated ballast water. 

3.3.6 Bioavailability/biomagnification/bioconcentration

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

account the following points: 

 .1 One bioconcentration factor (BCF) determined in a bioconcentration study 

(at two dosing levels) with fish (e.g., OECD 305) or bivalves. The BCF should be 

based on uptake/elimination kinetics (k1/k2). The half-life for elimination should 

be reported. Fat content in marine fish typically ranges between 0.5 and 15% of 

the whole body weight. BCF should be normalized to 6% fat; 

 .2 The biomagnification and persistence in the food web should be discussed based 

on the results from aquatic toxicity testing, mammalian toxicity evaluation and 

bioaccumulation and biodegradation data; and 

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

bio-availability in the toxicity test systems is equivalent to the conditions under 

assessment. If the bioavailability of the Active Substance or Relevant Chemical in 

the discharge or the receiving environment is to be assessed, consequently, the 

bio-availability in the toxicity testing is to be reconsidered. 

3.3.6.2 Such information on bioavailability/biomagnification/bioconcentration should be 

provided for: 

 .1 Active Substances; 

 .2 Any components of a preparation; and 

 .3 Relevant Chemicals. 

3.3.7 Food web/population effects

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

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

biodegradation data. 

3.3.7.2 An assessment of secondary poisoning is redundant if for the substance of concern 

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

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

.1 one long-term NOECs based on reproduction studies with a bird species; and 
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.2 two NOECs from long-term studies with two mammalian species (from section 3.4 

below). 

3.3.7.3 Such information related to the food web/population effects should be provided for: 

 .1 Active substances; and 

.2 Relevant Chemicals. 

3.4 Data on mammalian toxicity (G9: 4.2.1.2) 

3.4.1 General

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

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

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

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

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

Structure Activity Relationships (QSAR), and grouping or read-across with similar substances. 

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

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

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

during or after application of the BWMS should be provided as well. 

3.4.2 Acute toxicity

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

should be the oral route. Active Substances or Preparations that are gases should be tested by 

inhalation. 

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

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

proposed or potential application of the substance/products. 

3.4.2.3 Such information on acute toxicity should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.4.3 Effects on skin and eye 

3.4.3.1 The tests should provide information on the degree and nature of skin, eye and 

associated mucous membrane irritation, especially with regard to the reversibility of responses. 

The tests should provide sufficient information to assess the potential to cause skin sensitization 

reactions. Animal testing should, whenever possible, be minimized. Tests should be performed 

with the Active Substance(s) or Preparation(s). 
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3.4.3.2 Testing of Active Substances or Preparation should include a study on acute dermal 

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

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

(Acute Eye Irritation/Corrosion). These tests need not be carried out on a strong acid or base 

(pH below 2 or above 11.5). Where the Active Substance or Preparation has shown to have 

potentially corrosive properties, or is a severe skin irritant, an eye irritation test should not be 

carried out. Results from in vitro test methods, which are close to validation by recognized 

organizations, may be submitted. 

3.4.3.3 The recommended test for Skin Sensitization is OECD guideline 406. While the 

guinea-pig Maximization test is considered to be the preferred adjuvant technique in certain 

cases, there may be good reasons for choosing the Buehler test or the Local Lymph Node 

Assay (LLNA). However, scientific justification should be given when either of the two latter 

mentioned is used. The test is not needed if the Active Substance or Preparation is already 

classified in an internationally recognized system or otherwise known as a sensitizer. 

3.4.3.4 Such information related to the effects on skin and eyes should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.4.4 Repeated-dose toxicity

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

species, using the oral route unless another one is more appropriate. 

3.4.4.2 Such information on repeated dose toxicity should be provided for: 

 .1 Preparation including any of its components; 

 .2 Active Substance; and 

 .3 Relevant Chemicals. 

3.4.5 Chronic toxicity

3.4.5.1 There is a need for a chronic toxicity study of a minimum duration of 12 months 

in two species – one rodent and another mammalian species – unless a full justification 

demonstrates that this test is not necessary. 

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

3.4.5.3 Such information on chronic toxicity should be provided for: 

 .1 Preparation including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 
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3.4.6 Developmental and reproductive toxicity

3.4.6.1 Testing should include: 

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

Two-Generation Reproduction Toxicity Study); and 

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

(OECD guideline 414 – Prenatal Developmental Toxicity Study). 

3.4.6.2 However, these key data can be modified (either reduced or accelerated or extended) 

and influenced by factors such as structural relationships with a known reproductive toxicant, the 

results of other toxicity studies (including toxicokinetics), concerns for endocrine disruption and 

anticipated use, and human exposure patterns. Such information on developmental and 

reproductive toxicity should be provided for: 

 .1 Preparation including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.4.7 Carcinogenicity

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

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

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

be combined with the chronic toxicity studies. 

3.4.7.2 Such information on carcinogenicity should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.4.8 Mutagenicity/genotoxicity

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

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

an in vitro mammalian cell gene mutation assay. In case of positive or equivocal results, further 

in vivo mutagenicity testing with bone marrow assay for chromosomal damage or a micronucleus 

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

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

3.4.8.2 Such information on mutagenicity and genotoxicity should be provided for: 

 .1 Preparations including any of its components; and 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 
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3.4.9 Toxicokinetics

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

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

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

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

dermal absorption should be evaluated preferably in vitro or by physico-chemical data to reduce 

the need for any specific dermal toxicity testing. 

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

(G9: 4.2.1.3) 

3.5.1 General 

3.5.1.1 The rate and route of abiotic and biotic degradation of the Active Substances, components 

of a preparation and Relevant Chemicals under aerobic and anaerobic conditions should be 

assessed, resulting in the identification of relevant metabolites in the relevant media 

(ballast water, marine and fresh waters) (G9: 5.3.4). 

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

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

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

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

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

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

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

3.5.2 Modes of degradation (biotic; abiotic)

3.5.2.1 Testing should include: 

 .1 a study on hydrolysis at pH 5, 7, and 9 under aerobic conditions according to 

OECD guideline 111; 

 .2 a study on ready biodegradability according to OECD guideline 301 

(Ready Biodegradability) or equivalent guidelines if the Active Substance is 

discharged only into fresh water; 

 .3 a study on ready biodegradability according to OECD guideline 306 

(Biodegradability in Seawater) or equivalent guidelines if the Active Substance is 

discharged only into marine water; and 

 .4 studies on ready biodegradability according to OECD guideline 301 

(or equivalent guidelines) and OECD guideline 306 (or equivalent guidelines) 

if the Active Substance is discharged into estuarine water (e.g., inland harbour 

with contact to seawater). 

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

studies should be conducted: 
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.1 a study on aerobic and anaerobic transformation in aquatic sediment systems 

according to OECD guideline 308 (Aerobic and Anaerobic Transformation in 

Aquatic Sediment Systems) or equivalent guidelines if Koc >500 L/kg, using fresh 

or marine water depending on kind of aquatic ecosystem where discharge is 

intended. At least one system with high organic matter/nutrient content and one 

with low organic matter/nutrient content should be tested (see above); 

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

according to OECD guideline 309 (Aerobic Mineralization in Surface Water 

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

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

and 

 .3 where relevant, a study on photo-transformation in water 

e.g., US EPA OPPTS 835.2210 (1998) and/or OECD Guidance document 

on photo-transformation in water (1997). 

3.5.2.3 Such information on the modes of degradation should be provided for: 

 .1 Active Substances; 

 .2 any other components of preparations; and 

 .3 Relevant Chemicals. 

3.5.3 Bioaccumulation, partition coefficient, octanol/water partition coefficient

3.5.3.1 Testing should include: 

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

earlier in this document; 

.2 a study into the log Pow according to OECD guideline 107 (Partition Coefficient 

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

(Partition coefficient – n-octanol/water HPLC method) or equivalent test 

guidelines. For very hydrophobic compounds, a slow stirring method is 

appropriate (e.g., OECD 123 (Partition coefficient – slow stirring method)); and 

.3 the partition coefficient between solids and liquids should be determined 

e.g., according to EU Technical Guidance Document on Risk Assessment (2003) 

for at least three inocula, including freshwater sediment, marine sediment, and 

particulate matter (sludge)(OECD 106). If no measured data are available for a 

specific adsorbing material, it is assumed that all adsorption can be related to the 

organic matter of the medium, viz. standardization to Koc. This is only valid for 

non-ionic substances. For ionic substances, the Kp values and the test 

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

3.5.3.2 Such information on bioaccumulation and partition coefficients should be provided for: 

 .1 Active Substances; 

 .2 any other components of preparations; and 

 .3 Relevant Chemicals. 
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3.5.4 Persistence and identification of the main metabolites in the relevant media 

(ballast water, marine and fresh waters) 

3.5.4.1 The route of degradation in the higher tier simulation tests specified under section 3.5.2 

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

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

considered as Relevant Chemicals should be identified. 

3.5.4.2 Such information on persistence and metabolites should be provided for: 

 .1 Active Substances; 

 .2 any components of preparations; and 

 .3 Relevant Chemicals. 

3.5.5 Reaction with organic matter

3.5.5.1 The reaction of radicals produced by the action of Active Substances with organic 

matter should be addressed qualitatively as to identify products of concern to the environment 

and, where possible, quantitatively as to identify environmental concentrations. 

3.5.5.2 Radical producing chemicals are capable of forming halogenated 

(chlorinated, brominated) hydrocarbons that may be of concern to environmental or human 

health, in the presence of organic matter. For these substances, the freely and otherwise 

reasonably available information should be presented and discussed in relation to the proposed 

manner of application, since they are subject to the decision-making criteria. 

3.5.5.3 Such information on the reaction with organic matter should be provided for: 

 .1 Active Substances; and 

 .2 Relevant Chemicals. 

3.5.6 Potential physical effects on wildlife and benthic habitats 

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

Further guidance can be found in the MEPC-approved hazard evaluation procedure published 

as GESAMP Reports and Studies No.64. 

3.5.6.2 Such data on the potential physical effects on wildlife and benthic habitats should be 

provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; 

 .3 Relevant Chemicals; and 

 .4 Treated ballast water. 
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3.5.7 Potential residues in seafood

3.5.7.1 As appropriate, data should be submitted to assess the risk that residues of the Active 

Substance end up in seafood, the possible impact on consumer safety and the level of residues 

that may be tolerated in seafood. Any available monitoring data on residues of the substance in 

seafood should be submitted. 

3.5.7.2 Such data on potential residues in seafood should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.5.8 Any known interactive effects

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

Chemicals with the ballast water, with other preparations to be used in ballast water, with other 

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

be reported. 

3.5.8.2 Such information on known interactive effects should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.6 Physical and chemical properties for the Active Substances and Preparations and 

treated ballast water, if applicable (G9: 4.2.1.4) 

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

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

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

3.6.2 Melting point: Data on the melting point should be provided for: 

 .1 Preparations including any of its components; and 

 .2 Active substances. 

3.6.3 Boiling point: Data on the boiling point should be provided for: 

 .1 Preparations including any of its components; and 

 .2 Active Substances. 

3.6.4 Flammability (flash point): Data on the flash point should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 
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 .3 Relevant Chemicals. 

3.6.5 Density (relative density): Data on the density should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Treated ballast water. 

3.6.6 Vapour pressure, vapour density: Data on the vapour pressure and vapour density 

should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.6.7 Water solubility/dissociation constant: Data on the water solubility and dissociation 

constants should be provided for: 

.1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.6.8 Oxidation/reduction potential: Data on the oxidation/reduction potentials should be 

provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; 

 .3 Relevant Chemicals; and 

 .4 Treated ballast water. 

3.6.9 Corrosivity to the materials or equipment of normal ship construction: Data on the 

corrosivity to materials of construction should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; 

 .3 Relevant Chemicals; and 

 .4 Treated ballast water. 

3.6.10 Auto-ignition temperature: Data on the auto-ignition temperature should be provided 

for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 
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3.6.11 Explosive properties: Data on the explosive properties should be provided for: 

 .1 Preparations; 

 .2 Active Substance; and 

 .3 Relevant Chemicals. 

3.6.12 Oxidizing properties: Data on the oxidizing properties should be provided for: 

 .1 Preparations; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.6.13 Surface tension: Data on the surface tension should be provided for: 

 .1 Preparations; and 

 .2 Active Substances. 

3.6.14 Viscosity: Data on the viscosity should be provided for: 

 .1 Preparations; and 

 .2 Active Substances. 

3.6.15 Thermal stability and identity of relevant breakdown products: Data on thermal 

stability and identity of relevant breakdown products should be provided for: 

 .1 Preparations including any of its components; and 

 .2 Active Substances. 

3.6.16 Reactivity towards container material: Data on the reactivity towards container 

materials should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active substances; 

 .3 Relevant Chemicals; and 

 .4 Treated ballast water. 

3.6.17 pH: Data on the pH should be provided for: 

 .1 Preparations; and 

 .2 Treated ballast water. 

3.6.18 Salinity: Data on the salinity should be provided for: 

 .1 Treated ballast water. 
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3.6.19 TOC, DOC, % particulate matter: Data on the TOC, DOC and % of particulate matter 

should be provided for: 

.1 Treated ballast water. 

3.6.20 Other known relevant physical or chemical hazards: Data on the any other known 

relevant physical or chemical hazards should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; 

 .3 Relevant Chemicals; and 

 .4 Treated ballast water. 

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

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

analytical methods at environmentally relevant concentrations should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substance; and 

 .3 Relevant Chemicals. 

4 USE OF THE ACTIVE SUBSTANCE OR THE PREPARATION 

4.1 The manner of application 

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

preparation for the ballast water management (BWM), including required dosage and retention 

time (G9: 4.2.6). 

4.1.2 In relation to section 7 of Procedure (G9), the dossier should contain the necessary data 

addressing the following items: 

 .1 the technical manual or instructions by the Administration, including the product 

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

components and materials used, technical installation specifications, system 

limitations, and routine maintenance should be provided, including quantity to be 

added to ballast water and maximum concentration of the Active Substance 

therein; 

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

transport; 

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

combustion gases, etc.; 

 .4 emergency measures in case of an accident; 
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 .5 an indication of the possibility of destruction or decontamination following release 

in the marine environment; 

 .6 procedures of waste management of the Active Substance; 

.7 the possibility of reuse or recycling; 

 .8 the possibility of neutralization; 

 .9 conditions for controlled discharge; and 

 .10 the amount of substance on board ship. 

4.1.3 Appropriate risk management measures (e.g., for neutralization of the Active Substance 

in case of emergency or if PEC/PNEC at discharge >1) should be described. These management 

measures are an integral part of the ballast water management system and should be evaluated in 

the assessment. 

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

ship, personnel and the environment. 

5 MATERIAL SAFETY DATA SHEETS (G9: 4.2.7) 

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

been prepared for the United Nations Globally Harmonized System of Classification and 

Labelling of Chemicals (GHS) to aid in interpreting data for classifying substances as dangerous. 

Reference is also made to the MEPC-approved hazard evaluation procedure published as 

GESAMP Reports and Studies No.64 under the title “The Revised GESAMP Hazard Evaluation 

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

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

detailed guidance on hazard identification. 

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

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

hazardous under GHS, this should also be clearly stated. 

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

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

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

the Key Data Summary Table. 

6 RISK CHARACTERIZATION 

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

6.1.1 Persistence (G9: 5.1.1.1)

6.1.1.1 Persistence is preferably assessed in simulation test systems to determine the half-life 

under relevant conditions. Biodegradation screening tests may be used to show that the 

substances are readily biodegradable. The determination of the half-life should include 

assessment of Relevant Chemicals. 
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6.1.1.2 For persistence and degradation data, see sections 3.5.2 and 3.5.4 of this document. 

6.1.2 Bioaccumulation (G9: 5.1.1.2)

6.1.2.1 The assessment of the bioaccumulation potential should use measured bioconcentration 

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

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

For bioaccumulation data, see sections 3.3.6 and 3.5.3 of this document. 

6.1.3 Toxicity tests (G9: 5.1.2.3) 

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

be used for the assessment of the toxicity criterion. 

6.1.3.2 For ecotoxicity data, see section 3.3 of this document. 

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

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

assessment. 

6.1.4 Does the Active Substance and/or Preparation meet all three criteria for PBT?

See Procedure (G9): Table 1. 

Criterion PBT criteria 

Persistence Half-life: 

> 60 days in marine water, or 

> 40 days in fresh water,*

 or 

> 180 days in marine sediments, or 

> 120 days in freshwater sediments 

Bioaccumulation Experimentally determined BCF > 2,000, or if 

no experimentally BCF has been determined, 

Log Pow≥3 

Toxicity Chronic NOEC < 0.01 mg/L 

*

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

can be overruled by data obtained under marine conditions. 

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

approval in accordance with paragraph 6.4.1 of Procedure (G9). 

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

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

the potential aquatic toxicity of the Active Substance, Preparation including any of its 

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

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

the BWMS (G9: 5.2.1). 

6.2.1.2 A system using Active Substances or Preparations that have received Basic Approval by 

the Organization may be used for evaluation of ballast water management systems using Active 

Substances or Preparations for Final Approval (G9: 8.2.1). 

6.2.2 Final Approval

6.2.2.1 Toxicity tests with samples of ballast water treated with the BWMS down from the 

land-based test set-up should be conducted (G9: 5.2.1.2 and 5.2.3). 

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

Active Substance or Preparation to comply with the Convention (that received Basic Approval) 

must be approved by the Organization. 

6.2.3 Determination of holding time

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

discharge, i.e. the necessary dilution of the treated ballast water. The half-life, decay and dosage 

rates, system parameters and toxicity should be used to determine the amount of time needed to 

hold the treated ballast water before discharge (G9: 5.2.7). An indication of the uncertainty of 

the holding time should be given, taking into account variables (e.g., temperature, pH, salinity 

and sediment loading). 

6.3 Risk characterization and analysis 

6.3.1 Reaction with organic matter (see G9: 4.2.1.3; this document: 3.5.5)

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

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

Chemicals that may be of concern to the environment. 

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

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

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

(see 3.5.2 above) should be assessed, resulting in the characterization of the Active Substances, 

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

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

6.3.3 Prediction of discharge and environmental concentrations

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

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

selected time intervals should be predicted (G9: 5.3.8). 
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6.3.3.2 Environmental concentrations after discharge of treated ballast water under controlled 

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

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

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

components of Preparations, as appropriate, should be estimated. 

6.3.3.3 Environmental concentrations, under suitable emission scenarios to be developed 

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

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

Preparations, as appropriate. 

6.3.4 Assessment of potential for bioaccumulation

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

Chemicals, the potential for bioaccumulation should be assessed in marine or freshwater 

organisms (fish or bivalves) if the logarithm octanol/water partition coefficient (log Pow) 

is >3 (G9: 5.3.7). 

6.3.5 Effects assessment

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

components and Relevant Chemicals is initially based on a dataset of acute and/or chronic 

ecotoxicity data for aquatic organisms, being primary producers (algae or sea grasses), 

consumers (crustaceans), predators (fish), (G9: 5.3.9). 

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

avian top-predators where relevant. Only toxicity studies reporting on dietary and oral exposure 

are relevant, as the pathway for secondary poisoning refers exclusively to the uptake of 

chemicals through the food chain. It might be necessary to extrapolate threshold levels for 

marine species from terrestrial species assuming there are interspecies correlations between 

laboratory bird species and marine predatory bird species and between laboratory mammals 

(e.g., rats) and the considerably larger marine predatory mammals. An assessment of secondary 

poisoning is redundant if the substance of concern demonstrates a lack of bioaccumulation 

potential (e.g., BCF < 500 L/kg wet weight for the whole organism at 6% fat) (G9: 5.3.10). 

6.3.5.3 An assessment of effects to sediment species should be conducted unless the potential of 

the substance of concern to partition into the sediment is low (e.g., Koc < 500 L/kg) (G9: 5.3.11). 

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

taking the indicated information into account, should be based on internationally recognized 

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

6.3.6 Effects on aquatic organisms

6.3.6.1 For assessment of effects to the aquatic environment, appropriate 

Predicted No-Effect Concentrations (PNEC) should be derived. A PNEC is typically derived at a 

level that, when not exceeded, protects the aquatic ecosystem against toxic effects of long-term 

exposures. However, for situations where only short-term exposures are expected, an additional 

PNEC for short-term exposure may be useful. PNEC values are normally derived from 

short-term and/or long-term aquatic toxicity results for relevant aquatic species by dividing the 

lowest available effect concentration with an appropriate assessment factor. For the aquatic 

effect assessment, the assessment factors, given in Table 2, should be guiding although these may 

be altered on a case-by-case basis based on expert judgment. In cases where a comprehensive 
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data-set is available, the PNEC may be derived with a mathematical model of the sensitivity 

distribution among species. 

6.3.6.2 PNEC values should be derived for any substances that may be found in treated ballast 

water in concentrations that may be of concern for the aquatic environment. The relevance of 

deriving PNEC values for Active Substances, any other components of preparations and/or 

Relevant Chemicals should thus be considered. 

6.3.6.3 When aquatic toxicity data are available only for freshwater species but a PNEC for the 

marine environment (PNEC saltwater) is needed, this may be derived by applying a higher 

assessment factor than for the derivation of a PNEC fresh water to reflect the greater uncertainty 

in protecting sensitive species in saltwater environments. Where data are available for additional 

taxonomic groups, for example, rotifers, echinoderms or molluscs, the uncertainties in the 

extrapolation are reduced and the magnitude of the assessment factor applied to a dataset can be 

lowered. 

6.3.6.4 For naturally occurring Active Substances not meeting PBT-Criteria and being rapidly 

degradable, the PNEC could be set along the background concentration in the environmental 

compartment under consideration. 

Table 2 – Effect assessment for deriving PNECs for fresh water and saltwater

 

 Assessment Factor 

Data-set PNEClong PNECshort 

Freshwater assessment 

Lowest short-term L(E)C50 from freshwater 

species representing three trophic levels 

1000 10-100 

Lowest chronic NOEC from three freshwater or 

saltwater species representing three trophic levels 

10 

Saltwater assessment 

Lowest short-term L(E)C50 from marine species 

representing three trophic levels 

1000 10-100 

Lowest chronic NOEC from three freshwater or 

saltwater species representing three trophic levels 

100 

Lowest chronic NOEC from three saltwater 

species representing three trophic level 

100 

Lowest chronic NOEC from three freshwater or 

saltwater species representing three trophic levels 

+ at least two chronic NOECs from additional 

marine taxonomic groups 

10 

6.3.7 Effects on sediment

6.3.7.1 Because sediment constitutes an important compartment of ecosystems, it may be 

important to perform an effects assessment for the sediment compartment for those substances 

that are likely to transfer substantially into the sediment. Most of the existing whole sediment 

tests measure acute toxicity and only a few measure long-term, sublethal endpoints. Only the 

latter tests are considered applicable to risk assessment because of the long-term exposure of 

benthic organisms to sediment-bound substances that occur under field conditions. Due to the 

generally long-term exposure of benthic organisms to sediment-bound substances, long-term 

tests with sub-lethal endpoints like reproduction, growth, emergence, sediment avoidance and 
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burrowing activity are regarded as most relevant. It is recommended to use pooled marine and 

freshwater sediment toxicity data for effect assessment for the sediment compartment. However, 

when sufficient data for ecologically relevant saltwater species are available, lower assessment 

factors can be applied. Since there are no chronic marine sediment test methods that are 

internationally accepted, the results from any tests should always be evaluated with caution. 

Table 3 – Effect assessment for deriving PNECs for sediment 

Data-set Assessment factor 

Freshwater assessment 

Three chronic sediment tests with species representing different 

living and feeding conditions 

10 

Saltwater assessment 

Three chronic sediment tests with species representing different 

living and feeding conditions 

50 

Lowest chronic NOEC from three freshwater or saltwater 

species representing different living and feeding conditions 

including at least two chronic NOECs from marine species 

10 

6.3.8 Comparison of effect assessment with discharge toxicity

The results of the effect assessment of the substances that are likely to be present in the treated 

ballast water at discharge are compared to the results of the toxicity testing of the treated ballast 

water. Any unpredicted results (e.g., lack of toxicity or unexpected toxicity in the treated ballast 

water at discharge) should give rise to a further elaboration on the effect assessment (G9: 5.3.14). 

7 RISK ASSESSMENT 

7.1 Risk to safety of ship 

7.1.1 The potential risk to the safety of the ship and crew raised by the operation of the BWMS 

should be assessed, taking into account the identified risk mitigation measures to be applied and 

any relevant legislative requirements such as provided in SOLAS and MARPOL. Potential risk 

to the ship/crew may include, inter alia: 

 .1 increased corrosion; 

 .2 fire and explosion; 

 .3 storage and handling of the substances; 

 .4 contact with, or inhalation of, process products; and 

 .5 noise. 

7.2 Risks to human health

7.2.1 The human health risk assessment should follow generally accepted guidelines including 

acute and long-term exposure situations. The risk assessment should entail hazard identification 

and, as appropriate, dose (concentration) – response (effect) assessment, exposure assessment 

and risk characterization. The population groups deemed to be at risk and so to be examined 

should include crew, passengers and all personnel, including the public, in ports. Potential health 

risks connected to the exposure of consumers via seafood or persons at the coast (e.g., beach) 
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after discharge should be evaluated. Special attention should be given to service and repair of the 

system by technicians and accidental situations on board (e.g., specific personal protection 

equipment). The evaluation of the risks to human health should include risk reduction 

(risk management) by regulations based on the SOLAS Convention as well as specific measures 

proposed by the manufacturer and of the ballast water management system that should then be 

assessed by the Administration concerned. 

7.2.2 Health effects in humans 

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

should include a screening on carcinogenic, mutagenic and endocrine disruptive properties. 

If the screening results give rise to concerns, this should give rise to a further effect assessment 

(G9: 5.3.12). 

7.2.3 Human Exposure Scenario

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

risk assessment procedure for ballast water management systems, using the guidance contained 

in appendix 2 of this document (G9: 6.3.3). 

7.2.3.2 There are normally four stages when carrying a quantitative risk assessment: 

 .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? 

7.2.3.3 The identification of “unit operations” in the whole BWM process of each system is 

important to the understanding human exposures. 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. 

7.2.3.4 The risk assessment should include a description of 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. 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. The risk assessment should also include 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. 
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7.2.3.5 Maintenance, equipment failure and accident situations should be considered separately 

from conditions of normal operation. 

7.3 Risks to the aquatic environment

7.3.1 The potential risks to the aquatic environment during experimental development and type 

approval testing should be assessed. 

7.3.2 When no aquatic toxicity of the treated ballast water at discharge is found either through 

direct testing of the treated ballast water or if the estimates ratios between predicted 

concentrations of the Active Substance, components of preparations or Relevant Chemicals, as 

appropriate, and the respective PNEC values are below 1, no further assessment of direct toxic 

effects to the aquatic environment is necessary. 

7.3.3 In other cases, the dilution necessary to ensure that the PNEC values are not exceeded 

should be calculated by an appropriate model for relevant controlled use and discharge scenarios. 

7.3.4 The potential risks to the aquatic environment resulting from full-scale deployment 

on board ships and discharge of treated ballast water under representative conditions should be 

assessed. An Emission Scenario Document (ESD) should be provided by the applicant as part of 

the Risk Assessment procedure for ballast water management systems. The ESD should be based 

on the worst case discharge scenario and should be regarded as the first stage of a stepped 

approach to the development of a full ESD, when more data on potential discharges and 

technologies becomes available (G9: 6.4.4). 

8 ASSESSMENT REPORT (G9: 4.3)

8.1 The Assessment report referred to in section 4.3 of Procedure (G9) should at least 

provide: 

 .1 an overview of the data and endpoints on which the risk characterization 

according to section 6 of Procedure (G9) is based including a description of the 

quality of test reports; 

 .2 an assessment of risks to the safety of ships, crew (human health), the 

environment and resources (e.g., fisheries) in accordance with section 6 of 

Procedure (G9); 

 .3 if any monitoring has been conducted, a summary of the results of that 

monitoring, including information on the analytical methodology used, ship 

movements and a general description of the area monitored; 

 .4 a summary of the available data on environmental exposure and any estimates of 

environmental concentrations developed through the application of mathematical 

models, using all available environmental fate parameters, preferably those that 

were determined experimentally, along with an identification or description of the 

modelling methodology; 
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 .5 an evaluation of the association between the ballast water management system 

making use of Active Substances or Preparations containing one or more Active 

Substances to comply with the Convention in question, the related adverse effects 

and the environmental concentrations, either observed or expected based on the 

risk assessment and the effluent testing; 

 .6 a qualitative statement of the level of uncertainty in the evaluation referred to 

under the preceding paragraph; and 

 .7 a detailed description of risk management possibilities, e.g., for neutralization of 

the Active Substance in case of emergency or if PEC/PNEC at discharge >1. 

These management measures are an integral part of the ballast water management 

system. 

9 MODIFICATION TO THE APPLICATION

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

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

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

The Member of the Organization should inform the Organization accordingly (G9: 8.4.1). 

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

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

used in it should submit a new application (G9: 8.4.2). 

10 FINAL APPROVAL

10.1 In accordance with paragraph 5.2.1 of 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 section 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). The results should be conveyed to the Organization for 

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

undertaken for Basic Approval. This would result in Final Approval of the ballast 

water management system in accordance with regulation D-3.2. Active 

Substances or Preparations that have received Basic Approval by the Organization 

may be used for evaluation of ballast water management systems using Active 

Substances or Preparations for Final Approval (G9: 8.2.1); 

.3 it is to be noted that from the Guidelines (G8) land-based testing only the results 

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

in accordance with Procedure (G9). All other Guidelines (G8) testing remains for 

the assessment and attention of the Administration. Although Basic Approval 

under Procedure (G9) should not be a pre-requisite of Type Approval testing, as 

an Administration can regulate discharges from its own ships in its own 
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jurisdiction. Basic Approval would still be required, and the specific technology 

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

(G9: 8.2.2); 

 .4 it should be noted that once a system has received Final Approval under 

Procedure, then the respective applicant should not have to retrospectively submit 

new data if there is a change in the Methodology agreed by the Organization 

(G9: 8.2.3); 

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

intervals after treatment (preferably immediately after treatment and 

after a 24 or 48 hours interval), and organisms normally found in the selected 

types of seawater should be used in the toxicity testing; 

.6 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; 

.7 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 

.8 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. 

* * * 
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APPENDIX 1 

KEY DATA SUMMARY FORM FOR GESAMP-BWWG TECHNICAL EVALUATION 

OF BALLAST WATER MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE 

SUBSTANCES TO COMPLY WITH THE CONVENTION 

(For each piece of data selected for the Summary Form, the range of data that this has been 

chosen from should be included as an appendix e.g., if the Summary Form includes an 

Acute Oral LD50 for a Rat, the appendix should include the complete list of values identified in 

the literature from which this value was chosen as a proposal to the BWWG.) 

1 CHEMICAL IDENTIFICATION 

Trade Name of Preparation 

Composition of Preparation 

Component Chemical Name CAS Number Concentration (%) AS, RC or Other*

 

*

 Indicate whether the chemical is believed to be one of the following, giving justification for 

each proposal: 

AS = Active Substance 

RC = Relevant Chemical 

Other = Any other Chemical e.g., solvent 

List of ALL potential by-products produced in ballast water 

Chemical Name CAS Number Concentration 

(%)

(bio)degradation 

rate or half-life 

 

Notes: 1 A separate index for the Active Substance(s) and all by-products should be created 

unless a scientific explanation is provided to justify not including them. 

2 A chemical analysis should also be provided to show the concentration of possible 

by-products produced in the treated ballast water. Such analyses should be carried 

out to a level of detection commensurate with the level of naturally occurring 

chemical in seawater and/or the level that could be justified as not being 

hazardous to human health or the environment, where appropriate. 

 3 A clear description of, or reference to, the chemical analysis should be provided 

along with the length of time, after treatment, that the analysis was carried out. 

It is recommended that there should be: 

 .1 one analysis carried out following the shortest possible time that the 

treated ballast water would be permitted to be discharged; and 

 .2 one analysis carried out [5] five days later. 
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Data on each component of the 

preparation and by-product produced in ballast water

Chemical Name 

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

Where the applicant considers that it is not necessary to complete the data form for a 

given chemical, a full justification should be given (e.g., the 1⁄2-life of the chemical is only 

a few seconds and so will have disappeared by the time the ballast water is discharged 

into the sea) 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data 

Species LC50 

(mg/l/duration) 

Reference/Comments/Justification 

for missing data 

Fish 

Crustacea 

Algae 

2.2 Chronic Aquatic Toxicity Data 

Species LC50(mg/l/duration) 

or 

NOEC(mg/ l 

/duration 

Reference/Comments/Justification 

for missing data 

Fish 

Crustacea 

Algae 

2.3 Information on Endocrine Disruption 

Species Information Reference/Comments/Justification 

for missing data 

Fish 

Crustacea 

Algae 

2.4 Sediment Toxicity 

Species Information Reference/Comments/Justification 

for missing data 

Fish 

Crustacea 

Algae 

2.5 Bioavailability/Biomagnification/Bioconcentration 

Log Pow Reference/Comments/Justification 

for missing data 

BCF 
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2.6 Food Web/Population Effects 

A description of potential food web and population effects should be provided supported 

by a full justification. 

3 MAMMALIAN TOXICITY 

3.1 Acute mammalian Toxicity

 Value Species Reference/Comments/Justification 

for missing data 

Oral LD50 (mg/l) 

Dermal LD50 (mg/l) 

Inhalation LC50

(mg/l/4 h) 

 

3.2 Corrosion/Irritation 

 Species Method Results 

(including 

scores where 

available) 

Reference/Comments/Justification 

for missing data

Skin 

Eye 

3.3 Sensitization 

 Species Method 

(e.g., Buehler, 

M&K) 

Results 

(Sensitizer 

Y/N) 

Reference/Comments/Justification 

for missing data

Skin 

Inhalation 

3.4 Repeated-Dose Toxicity 

Exposure Route 

Exposure Duration 

Exposure dose 

Species 

Method 

Results 

NOAEL 

NOEL 

Reference/Comments/ 

Justification for missing data 
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3.5 Development and Reproductive Toxicity 

Exposure Route 

Exposure Duration 

Exposure dose 

Species 

Method 

Results 

NOAEL 

NOEL 

Reference/Comments/ 

Justification for missing data 

3.6 Carcinogenicity/Mutagenicity/Reprotoxicity 

 Species Method Details Results Reference/Comments/ 

Justification for 

missing data 

Carcinogenicity 

Mutagenicity 

Reprotoxicity 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND ANAEROBIC 

CONDITIONS 

4.1 Modes of degradation (biotic and abiotic) 

 Sea 

water or 

Fresh 

Water 

Test 

Duration 

Results Break-down 

products 

Reference/Comments/ 

Justification for 

missing data 

Hydrolysis 

at pH 5 

 

Hydrolysis 

at pH 7 

Hydrolysis 

at pH 9 

Biodegradation 

1/2-Life NR 

4.2 Partition Coefficients 

 Method Results Reference/Comments/Justification for 

missing data

Log Pow 

Koc 
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4.3 Persistence and Identification of Main Metabolites 

 Method Results Reference/Comments/Justification 

for missing data

Persistence 

 

4.4 Reaction with Organic Matter 

4.5 Potential Physical Effects on Wildlife and Benthic Habitats 

4.6 Potential Residues in Seafood 

4.7 Any Known Interactive Effects 

5 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER, IF APPLICABLE 

Property Value Reference/Comments/Justification 

for missing data 

Melting point (°C) 

Boiling point (°C) 

Flammability (flash point for liquids; °C) 

Density (20°C; kg/m3) 

Vapour pressure (20°C; Pa) 

Vapour density (air = 1) 

Water solubility (temp; effect of pH; mg/l) 

pH in solution 

Dissociation constant (pKa) 

Oxidation-reduction potential 

Corrosivity to material or equipment 

Reactivity to container material 

Auto-ignition temperature (°C) 

Explosive properties 

Oxidizing properties 

Surface tension 

Viscosity 

Thermal stability and identity of 

breakdown products 

Other physical or chemical properties 
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6 OTHER INFORMATION 

6.1 Analytical Methods for Measuring the Concentration at environmentally Relevant 

Concentrations 

Method 

Applicability 

Sensitivity 

Reference/Comments/Justification 

for missing data 

6.2 Material Safety Data Sheet provided (Yes/No) ................................................ 

6.3 GHS Classification .................................................................................. 

6.4 Risk Characterization 

Persistent (y/n) Bioaccumulative 

(y/n) 

Toxic (y/n) Reference/Comments/Justification for 

missing data 

 

* * * 
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APPENDIX 2 

HUMAN EXPOSURE ASSESSMENT 

1 INTRODUCTION 

1.1 In risk assessment for human health, the normal procedure is to compare the exposure 

levels to which the population is exposed or likely to be exposed with those levels at which no 

toxic effects are expected to occur. 

1.2 There are normally four stages when carrying a quantitative risk assessment: 

 .1 Hazard identification – 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. 

1.3 The greatest part of information about the potential human toxic effects of chemical 

substances is obtained from studies on animals. 

1.4 In assessing an acceptable level of a particular substance, the procedure usually follows 

moving from an experiment database of animal or preferably human data (e.g., epidemiological 

studies) giving a No Observed Adverse Effect Level (NOAEL) or a Lowest Observed Adverse 

Effect Level (LOAEL) to deriving exposure limit at a lower exposure value, to allow for the 

uncertainties in the data. Comparison of this exposure limit with a measured or estimated 

exposure level is then used to judge whether the situation is satisfactory or whether risk 

management measures are required. 

2 THE MARGIN OF SAFETY (MOS) OR MARGIN OF EXPOSURE (MOE) 

APPROACH 

2.1 In this procedure the ratio of NOAEL determined in the animal studies and expressed in 

mg/kg/day is compared with the level to which a human may be exposed: 

 MOS or MOE = NOAEL mg/kg/d

 Exposure mg/kg/d 

2.2 Assuming that the exposure of a human population to a substance in drinking water 

is 1 mg/L, for 60 kg woman consuming on average 2 L of water/day, then: 

 Exposure= 1 mg/L x 2 L/day = 0.03 mg/kg/day 

 60 kg 
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2.3 The next step in the MOS approach is to derive and apply a so-called “reference MOS” 

(MOSref). The MOSref is an overall assessment factor (AF) addressing differences between 

animal experimental data and real human exposure situation, taking into account variability and 

uncertainty. Normally, the value for each AF is based on substance-specific information or, 

if missing, on default values. It is common in Human Risk Assessment to use an MOSref 

of 100 (10 for interspecies variability – between animals and humans – and 10 for intraspecies 

variability – among humans). 

2.4 Example: taking into account the exposure value referred in 2.2. (0.03mg/kg/day) and, 

for instances, a NOAEL for developmental toxicity of 100 mg/kg/day, the MOS will be 100/0.03, 

i.e. 3333, a reassuring large value comparing to MOSref (100). However, if this value was much 

lower or lower than MOSref, it would indicate an inadequate MOS value over the NOAEL and 

an unacceptable human risk towards this adverse effect. 

2.5 The selection of the critical NOAEL for RA will depend on the extent, duration and 

route of human exposure and the selection of the most critical adverse effect. 

3 EXPOSURE ASSESSMENT 

3.1 The aim of assessing human exposure is to obtain a realistic estimate of total human 

exposure, expressed in terms of dose per unit weight, e.g., mg/kg. 

3.2 In principle, the exposure of a human population could be assessed by representative 

monitoring data and/or model calculations based on available information on substances with 

analogous uses and exposure patterns or properties. 

3.3 The predictions of exposure levels should describe a reasonable worst case situation, 

covering normal use patterns and where general public or workers may be exposed to the same 

substance. It is important to assess the reliability and the representativeness of the exposure 

measurements. 

3.4 Where data are of an unsatisfactory quality, it is useful to conduct an assessment using 

“worst case” assumptions. If this indicates a risk of no concern, the assessment needs no further 

refinement. 

3.5 The most probable scenarios for human exposure to BWMS still need to be properly 

identified. However, one can assume two potential groups, with some characteristics of each and 

expected route of exposure as follows: 

 .1 Crew (exposed occupationally): 

 .1.1 exposure assumed during working week – 8-hour day, 5 days per week; 

 .1.2 relatively healthy part of general population; and 

 .1.3 exposure routes: normally inhalation and dermal. 
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 .2 General public/Human exposure via environment – Users of coastal amenities, 

beach coastlines and offshore installations and harbours: 

 .2.1 exposure intermittent – needs to be estimated; 

 .2.2 exposures may not be controlled; 

 .2.3 exposure routes: oral, inhalation and/or dermal; and 

 .2.4 includes vulnerable groups e.g., children and elderly people. 

3.6 Normally occupational exposure will be an external exposure, i.e. the amount in contact 

with the skin, inhaled, or the concentration in the atmosphere. Where the conclusion is that this 

level “is of concern”, it may be necessary to determine internal exposure, i.e. the amount taken 

into the tissues of the body, or its bioavailability. 

3.7 The predictions of the consequences of exposure have to be carried out for each exposed 

human population (e.g., workers, general public) and for each effect. 

4 OCCUPATIONAL EXPOSURE 

4.1 The most common routes of exposure in the workplace are by inhalation or by absorption 

through intact skin. Dermal exposure may also result in local effects, such as irritation or 

dermatitis. 

4.2 Exposure should always be assessed in the first instance for the unprotected worker and, 

if appropriate, a second assessment should be made taking PPE (personal protective equipment) 

into account. 

4.3 Of primary importance in developing the assessment of occupational exposure is a full 

understanding of the processes and unit operations in which exposure occurs, and of the actual 

work activities resulting in exposure. With this background knowledge, the following questions 

have to be answered: 

 .1 what is the population of potentially exposed individuals? 

 .2 what are the magnitude, frequency and duration of inhalation and dermal 

exposures? 

 .3 what personal protective equipment and control measures are used to reduce or 

mitigate exposure? and 

 .4 how effective are they in reducing exposure? 

4.4 The overall assessment of each type of exposure should be repeated for all the various 

production processes and uses made for the chosen chemical, and from a knowledge of the 

frequency and duration of exposure the “worst case” highlighted. 
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4.5 If “real” data are missing for a chosen substance, as an alternative to modelling it may be 

possible to substitute data from another chemical with a similar pattern of exposure. 

4.6 The following major factors can affect exposure potential: 

 .1 size of activity – the greater the quantity of the substance involved or the higher 

the concentration in solution, the greater the potential for exposure is likely to be. 

Any potential hazard from 10 tons is likely to be much greater than that of 10 mg; 

 .2 physical characteristics of the activity – particle size of a solid or volatility of a 

liquid are also likely to affect the exposure, as is the presence of barriers to the 

exposure and containment of the substance away from human contact. Procedures 

involving elevated temperature, particularly with substances with significant 

vapour pressures, may engender an enhanced inhalation exposure; and 

 .3 time of exposure – the duration and frequency of exposure to an activity will also 

be a factor – the longer the time of exposure the higher the exposure potential. 

4.7 The quantitative human exposure assessment results in a reasonable worst-case estimate 

for external exposure via the inhalation and dermal route (the main routes of concern for 

occupational exposure) that are taken forward to the risk characterization. 

4.8 These estimates are obtained for all relevant scenarios that have been identified taking 

into account all relevant available information. 

4.9 In the risk characterization phase these estimates are combined with the results of the 

effects assessment and conclusions are drawn whether or not there is a concern for any scenarios 

assessed. 

5 CONTROL OF THE RISK 

5.1 When a risk assessment results in the conclusion that the risk is too high, consideration 

has to be given to introducing the following controls that will lower this risk to acceptable levels: 

 .1 Prevention that includes: 

 .1.1 elimination; 

 .1.2 substitution; and 

 .1.3 good hygiene practice. 

 .2 Physical segregation that includes: 

 .2.1 complete enclosure with extraction; 

 .2.2 local exhaust ventilation with or without partial enclosure; and 

 .2.3 screening. 
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.3 Personal protection that includes: 

 .3.1 respiratory protective equipment including respirators and self-contained 

breathing apparatus; and 

 .3.2 protective clothing (eye and head protection, gloves, shoes, etc.). 

6 OCCUPATIONAL EXPOSURE QUESTIONS 

6.1 Questions need to be addressed by the applicant in the Application for Basic Approval of 

a BWMS are as follows: 

.1 What are the chemical substances/products used/generated at the workplace and 

what is their physical-state (gas, liquid or solid) and concentration? 

.2 Where and how the substances/products are used/generated at the workplace? 

.3 By whom the substances/products will be directly used (primary exposure)? 

.4 Description of the operator tasks, frequency and duration at each operation unit – 

please include the relevant tasks in the process flow chart. 

.5 What are the expected measures to reduce worker exposure (PPE, RPE)? 

.6 Who else may be exposed (secondary exposure)? 

7 REFERENCES 

 .1 Chemical Risk Assessment – UNEP/IPCS, WHO, 1999; and 

 .2 Technical Guidance Document on Risk Assessment, European Chemicals Bureau 

(ECB) – Part I, European Communities, 2003. 

***

GESAMP-BWWG 6/9 

I:\MEPC\58\2-7.DOC 

ANNEX 5 

REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER MANAGEMENT 

SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES 

TG Ballastcleaner and TG Environmentalguard 

 

Submitted for Basic Approval by Japan 

0 SUMMARY 

0.1 The Group noted that the TG Ballastcleaner/TG Environmentalguard system uses a 

combination of filtration and chemical treatment to treat the ballast water followed by further 

chemical treatment to neutralize the Active Substance. 

0.2 The Group noted that this system requires the onboard storage of chemicals used in this 

system. To address the hazards associated with the release in the environment and human 

exposure, the Group used the highest concentration levels of the chemicals present in the 

mixtures and therefore the outcome represented a worst-case scenario. 

0.3 With the additional information received during the meeting of the GESAMP-BWWG, 

the Group was of the opinion that Basic Approval should be granted to the BMWS that makes 

use of TG Ballastwater and TG Environmentalguard submitted by Japan. 

0.4 When applying for Final Approval in the future the following subjects need to be 

addressed carefully: 

 .1 Considering corrosion, the Group agreed that the applicant’s response was 

insufficient to quantitatively assess the corrosion impact to relevant metallic and 

non-metallic materials likely to be used in ballast water tanks, piping and fixtures. 

For non-metallic gasket materials, the applicant responded that tests were not 

started since they have sufficient information for suitable materials but no details 

or data were provide. 

 .2 The applicant should provide appropriate QAs and QCs and indicate why there are 

different detection limits for the same substance being analysed. 

 .3 Further measurement and analysis of discharge concentration of THMs and HAAs 

with adequate QA/QC should be taken during the full scale land-based test before 

the submission of final approval. 

 .4 The chemical analyses for THMs were not performed under adequate QAPPs and 

so recommended that all chemical measurement and analyses should be performed 

under QAPPs. 

 .5 Final Approval submission should provide full details of the dosing control 

arrangements so as to ensure certainty of maintaining specified dosage levels of 

Active Substances. 
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 .6 The Group was satisfied that the flow diagram, provided, was suitable for 

Basic Approval. It is appreciated that further details for evaluation be supplied for 

review during any Final Approval. 

 .7 The applicant indicated to continue gathering information related to the two 

chemicals, bromochloroacetic acid and bromodichloroacetic acid and, if no 

additional data were to be found, they would carry out further algal tests as 

required. 

 .8 The Group was satisfied that the applicant had given due preliminary 

consideration to the concerns concerning temperature control put forward but 

requested that these safety mitigation measures and requirements should be fully 

detailed in the operating manual presented for any Final Approval. 

 .9 Whilst recognizing the validity of the pressure monitoring/control, the Group 

considered that further verification of this should be made during the ship board 

testing and included in the documentation for Final Approval. 

 .10 The Group is of the opinion that the acute toxicity testing for treated ballast water 

is needed and that the information for acute toxicity testing by simulated ballast 

water in a laboratory scale and full scale land-based system for evaluation. 

In addition the Group requested that quantification analysis and degradation rates 

of sodium sulphite in various conditions should be carried out for the submission 

for Final Approval. 

 .11 The Group recommended that the following human exposure information related 

to TG BallastCleaner should be addressed: 

 .1 in advance identification of all leaking points; these are to be considered 

critical points for the HSE (due to the corrosive properties of the 

preparation); 

 .2 foreseen safety measures for spills/leaks in the waste water collection tank; 

and 

 .3 manual handheld (residual chlorine meter) measurements of residual 

chlorine concentration in the waste water tank. 

1 INTRODUCTION 

1.1 The data used to evaluate this system were extracted from that supplied by the Japanese 

document MEPC 57/2/8 which was supplemented by additional confidential information 

provided by the applicant. Further information was provided by the applicant in response to 

specific questions posed. 

2 COMPLETENESS OF DOSSIER 

2.1 The Group agreed that further information should have been provided and so 

clarifications were requested. The queries (Q) put to the applicant, its answers (A) and 

the Group’s reaction (R) are summarised in the rest of this section. 
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2.2 (Q) Corrosion – While several references are made within the dossier regarding the 

corrosiveness of the treatment the anticipated severity is not estimated. Mitigation measures of 

epoxy coatings or linings are also identified, but it is not clear what the corrosion rate within 

coatings defects or uncoated materials may be. Are there any quantitative test or literature data 

available which characterize the corrosivity of TG Ballast Cleaner on steel, galvanized steel, 

zinc anode materials used in cathodic protection systems or common gasket materials 

(e.g., EPDM rubber)? 

2.2.1(A) In response to this question, the applicant stated that it had compared the differences of 

corrosion under the seawater with and without sodium hypochlorite at the available chlorine 

concentration of 20 mg/L. 

2.2.2 There were no differences between the epoxy coated steel and galvanized steel. 

For uncoated steel, there were some differences in the corrosion rates and we are continuing to 

collect the quantitative data. For coating defect, small differences were observed so far and we 

are still continuing to collect more data. For zinc anode materials used in cathodic protection 

systems, we have not started the corrosion test yet but we will start the test to evaluate the 

effectiveness of the cathodic protection systems. For gasket materials we have not started the 

corrosion test yet, because we have enough information of the suitable materials for gasket even 

at higher concentration of sodium hypochlorite such as TG Ballastcleaner. 

2.2.3 (R) With respect to the effect of TG BallastCleaner on tank and pipe coatings, the Group 

considered the applicant’s response to be thorough since a substantive test report was provided, 

but that these results were only indicative of performance using the proposed Active Substance 

since the tests were conducted at a reduced concentration. The applicant did answer the Group’s 

query sufficiently regarding acceptable materials for Active substance storage and distribution 

piping. Finally, with respect to corrosion, the Group agreed that the applicant’s response was 

insufficient to quantitatively assess the corrosion impact to relevant metallic and non-metallic 

materials likely to be used in ballast water tanks, piping and fixtures. For non-metallic gasket 

materials, the applicant responded that tests were not started since they have sufficient 

information for suitable materials but no details or data were provide. 

2.3 (Q) Representative concentration of bromoform - The highest discharge concentration 

for the Bromoform was measured during the early life stage toxicity testing against Java Medaka

(ref. 14-5(2)). During the same test period, the variation in the concentration was measured 

(ref. 14-5(1) and (ref. 14-5(3)). The Group considered that the QA and number of samples 

analysed fell far short of a representative values for THMs and HAAs and so requested an 

explanation of why there was such a huge variation observed during the same toxicity testing 

period. 

2.3.1 (A) The applicant stated that the certificated reference 14-5(2) clearly states that sampling 

timing was on 27th October and sample is moved to laboratory on 1st November. 

2.3.2 (R) The Group concluded that as this sample was four days old, it was possible that volatile 

organic compounds such as THMs were not representative of the true concentrations which were 

expected to be higher and so asked how can this old sample be regarded as representative? 

Furthermore the certification paper does not include the procedures for analysis methods, and 

storage conditions during the movement and repeatability results. The applicant should provide 

appropriate QAs and QCs and indicate why there are different detection limits for the same 

substance being analysed. 
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I:\MEPC\58\2-7.doc 

2.3.3 (A) In answering this query, the applicant stated: 

 .1 the variation of bromoform concentrations shown in Table 4-1-1 is possibly due to 

the differences in temperature as the experiment was not conducted in the 

temperature controlled room, which may be equivalent to the actual ballast water. 

Furthermore, this experiment was intended to examine the toxicity of the 

simulated ballast water and the analysis of THMs is conducted as references. 

The reason why the concentrations of HAAs were not measured was that at the 

time of this experiment we did not pay attention to HAAs as referenced 

substances. If it is required, we are ready to conduct the experiments again and 

analyse HAAs along with more data for THMs formed in seawater from the 

Port of Oigawa, for example; 

 .2 for the storage condition, “Samples are sealed after sodium sulphite is added, and 

are kept in a cool and dark place until quantitative analysis.” as stated in the note 

of Table 4-1-1 on page 67 of the “Report on Assessment”, which is in accordance 

with JIS K 0102, “Testing methods for industrial wastewater” published by 

Japanese Industrial Standards Committee. Therefore, we consider THMs were 

preserved until analysis; 

 .3 the analysis method of THMs in the Reference 14-4(1) was headspace GC 

with ECD. Since we failed to clarify as GC with ECD in this reference, we would 

like to add this information at the time when we are allowed to apply for the final 

approval; 

 .4 the analysis method of THMs in the References 14-5(1), (2) and (3) was HS 

(Headspace)-GC/MS as stated in those test reports; 

 .5 regarding the QAs and QCs of these experiments they were conducted in 

accordance with the standard analysis methods of JWWA (Japan Water Works 

Association); and 

 .6 the differences in the Detection limits come from the differences in the 

laboratories that we used for conveniences. We will try to keep conformity in 

the Detection limits hereafter. 

2.3.4 (R) Having considered these additional clarifications, the Group considered that the further 

measurement and analysis of discharge concentration of THMs and HAAs with adequate QA/QC 

should be taken during the full scale land-based test before the submission of final approval. 

2.3.5 The Group noted that, from the response of the applicant, the maximum discharge 

concentrations of THMs (i.e. bromoform ) had been measured during the laboratory-scale 

toxicity testing. The Group recognized that the simulation procedure for treated ballast water in 

laboratory-scale tests had significant differences between that of onboard testing. The Group 

noted that after adding the neutralizer, the stirring process was performed in 20 minutes. Such a 

long stirring process could reduce the concentration of volatile by-products and so might not be 

representative of those in discharged ballast water. 
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2.3.6 For the QA/QC, the Group noted that the applicant had not provided QAPPs for 

chemical analysis which had been performed in several laboratories and also noted that some of 

the certificated reports for volatile THMs stated that the sampling date and person in charge of 

sampling were “unknown”. The Group strongly recommended that all chemical measurement 

and analyses should be performed under QAPPs and result of DQOs also should be included in 

the certificated reports. 

The Group strongly recommended that all chemical measurement and analyses should be 

performed under QAPPs and result of DQOs also should be included in the certificated reports. 

2.4 (Q) Dose - It was noted that the submission indicated that a dose rate of 20 mg/L FAC is 

required to ensure efficacy and that the maximum intended dosage to the ballast water 

is 30 mg/L FAC. It was also noted that the concentration of free active chlorine 

in TG Ballastwater is 5–13 wt%. 

2.4.1 With the large variation in the concentration of FAC that may be available, the Group 

wanted to know how the dosing rate to ballast water is to be monitored and controlled to ensure 

the required levels are obtained and not exceeded. 

2.4.2 (A) The applicant indicated that since the concentration of sodium hypochlorite 

in TG Ballastcleaner is explicitly known for each delivery, the concentration of FAC is 

controlled at a specified level using information from Flow Meter and chlorine sensor as shown 

in Figure 2-1 on page 6 of the “Report on Assessment”. 

2.4.3 (R) The Group accepted that the applicants’ response was sufficient for the purposes of 

a Basic Approval evaluation. However, any Final Approval submission should provide full 

details of the dosing control arrangements so as to ensure certainty of maintaining specified 

dosage levels of Active Substances. 

2.5 Coating system of storage equipment and piping - The Group noted that appropriate 

materials for the storage tank of TG Ballastcleaner are stated in paragraph 5-2-3 on page 107 of 

the “Report on Assessment”. The Group noted that: 

 .1 the internal surfaces of piping and valves running from storage tank to injection 

nozzle which come into contact with the chemical are made of titanium, steel with 

lining or a coating of polypropylene, polyethylene, or polyvinyl chloride; 

 .2 the internal surfaces of chemical injection pump and nozzles which contact with 

the chemical are made of the same materials described above; 

 .3 appropriate materials for the storage tank of TG Environmentalguard are stainless 

steel or steel with lining or coating of polypropylene, polyethylene, or polyvinyl 

chloride; and 

 .4 the chemical injection system designed for onboard tests are shown in appendix 2, 

as an example. 

2.6 The Group agreed that appropriate initial consideration had been given to the selection of 

coatings and materials for the storage tank and injection piping. The application for final 

approval should further specify the detailed requirements for corrosion protection for all parts of 

the treatment system. 
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2.7 Dissimilar metals, galvanized piping/zinc anodes – The Group started to examine the 

effect of ballast water treated with TG Ballastcleaner on dissimilar metals, galvanized piping zinc 

anodes with limited results. However, this will be fully examined during consideration of the 

application for Final Approval. 

2.8 (Q) Schematic of system/monitoring/control/safety (gas detection/alarms/protection of 

crew – The Group requested a detailed schematic diagram of the intended plant showing valve 

positioning, monitoring and control functions, and alarm detector sites. 

2.8.1 (A) The applicant provided a system flow diagram and the list of equipment. 

2.8.2 (R) The Group was satisfied that the flow diagram, provided, was suitable for Basic 

Approval but more details should be supplied for review during any Final Approval. 

2.9 (Q) SDS & Classification and Labelling - The Group noted that, according to the SDS 

for TG Ballastcleaner this preparation is classified according to European regulations (section 15) 

as Irritant with risk phrases R31 and R36/37/38. However the pH is stated to be above 11.5 

(section 9), which would justify a classification of R34 (Corrosive, Causes burns). As a result, 

the Group asked if the data under section 11 relate to the preparation or to sodium hypochlorite. 

2.9.1 In addition, it was noted that TG Environmentalguard is classified in the same way as TG 

Ballastcleaner and so requested justification for this as, according to European regulations, both 

sodium sulphite and sodium sulphate are non-classified (The information in section 15 appeared 

to be a copy of the same section in TG Ballastcleaner). 

2.9.2 Furthermore, the Group noted some inconsistencies in the SDS since the data presented 

under section 11 is not in accordance with the classification as presented under section 15, and 

the symptoms described under section 3. 

2.9.3 The Group also noted that there was no correlation between the concentration of sodium 

hypochlorite in TG Ballastcleaner and the data under section 11 of the corresponding SDS. 

The applicant was asked to comment on these apparent discrepancies. 

2.9.4 (A) In response, the applicant indicated that section 15 of the SDS 

for TG Environmentalguard was deliberately taken from that of TG Ballastcleaner to provide a 

safer operation. 

2.9.5 (R) The Group was concerned about the answers to these queries and so, to assist the 

applicant, referred to the regulations according to GHS (UNECE, second revised edition, 2007) 

where the following is said under A4.3.11.2 about the information required for section 11 of 

the SDS: 

 “The data included in this subsection should apply to the substance or mixture as used. 

The toxicological data should describe the mixture. If that information is not available, 

the classification under GHS and the toxicological properties of the hazardous ingredients 

should be provided.” 
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2.9.6 The Group agreed that all information in a Safety Data Sheet has to be in line, if a 

preparation is unclassified then the recommendations for e g measures for First Aid have to be 

made accordingly. It is not acceptable to deliberately over-classify a substance or a preparation, 

that is, to “upgrade” the information in section 15 (which should reflect the information on the 

label). 

2.9.7 The applicant indicated that there are two versions of the TG Ballastcleaner, one 

with 5-6% of sodium hypochlorite and one with 12-13% of sodium hypochlorite. In accordance 

with current European regulations (directive 1999/45/EC) for classification this would result in 

the two different preparations of TG Ballastcleaner requiring two different classifications, the 

first is an Irritant (R31-36/38) and the second one is Corrosive (R31-34) (since the classification 

limit of 10% is exceeded). The Group decided, for its work, to use the 13% of sodium 

hypochlorite as a worst-case scenario. 

2.9.8 (Q) Details of the composition of TG Ballastcleaner and TG Environmentalguard – 

The Group requested more precise information about the amount of sodium hypochlorite in 

the TG Ballastcleaner. In particular, it wanted to know whether the amount was above 10%, or 

below as the submission indicated a concentration range that straddles this classification limit, 

i.e. 5-13%. (Classification limit for classifying as corrosive according to European regulations 

is 10%). 

2.9.9 (A) In response, the applicant indicated that there were two types of TG Ballastcleaner, 

one with concentrations ranging from 5.5-6% and the other with concentrations 

ranging from 12.5-13%. In addition the applicant stated that the concentration of 

TG Environmentalguard was normally above and around 10% and at the most 22%. 

2.9.10 (R) The Group noted this response which was regarded as acceptable for Basic Approval. 

2.10 (Q) Bromodichloroacetic acid and dibromochloroacetic acid data – It was noted that 

in the dossier presented to the Group, there was no information on the potential 

Relevant Chemicals, bromochloroacetic acid and bromodichloroacetic acid. 

2.10.1 (A) The applicant indicated that analyses for both chemicals had been carried out but the 

substances were below the limit of detection. In addition the applicant was of the opinion that 

only trace amounts would be formed during the formation of disinfection by-products (DBP). 

2.10.2 (R) The Group agreed with the applicant that both substances should be exempt from a 

detailed risk assessment. Nevertheless, the Group indicated that it would appreciate being kept 

informed of any newly established (eco)toxicological information. However, the Group did not 

agree with the statement of the applicant that a risk assessment is not needed because of missing 

information. 

2.10.3 In this context, the Group noted that the applicant was continuing to gather information 

related to these two chemicals and, if no additional data were to be found, they would carry out 

further algal tests as required. 

2.11 (Q) Oxygen deficiency in discharged water – Recognizing that the neutralizing agent, 

sodium sulphite, causes oxygen deficiency when added to the discharge ballast water and that the 

limit for chronic oxygen deficiency is 4.8 mg/L, the Group asked if there were plans to monitor 

the dissolved oxygen (DO) concentration in the treated ballast water to ensure that it is above this 

limit prior to discharge. Are there any plans to raise the DO by e.g., aeration? 
GESAMP-BWWG 6/9 

ANNEX 5 

Page 8 

I:\MEPC\58\2-7.doc 

2.11.1 (A) In response, the applicant indicated that there is no intention to use equipment to 

increase the DO as there is no significant deficiency of oxygen in discharged water with normal 

dosage of sodium sulphite. It was also indicated that, in practical experiments it was shown that 

unless the concentration of sodium sulphite is over 40mg/L, no oxygen deficiency was created. 

Therefore, the discharged water does not have any effects on the survival of marine organisms. 

2.11.2(R) The Group accepted the explanation of the applicant that the calculated concentration 

of sodium sulphite would not cause any significant oxygen deficiency in the discharged ballast 

water. 

2.12 (Q) Temperature control – It was noted that TG Ballastcleaner has to be kept in the 

temperature range 0oC – 20oC and that lagging of piping between storage tank and injection unit 

may be necessary to avoid freezing. However, the Group recognized that the environment that 

ships operate in frequently exceeds 20o

C especially in the engine room where the injection 

equipment will be usually installed. As a result, the applicant was asked what provisions were 

being taken to ensure the maximum temperature of storage tank and piping remains below 20oC? 

2.12.1(A) The applicant informed the Group that TG Ballastcleaner is to be chilled by the 

electrical chilling system as shown in Figure 4-1-1 on page 65 of the “Report on Assessment”. 

Chilled TG Ballastcleaner is supplied from storage tank into piping during the operation of the 

system. After the operation TG Ballastcleaner in the piping is replaced with water. 

2.12.2(R) The Group was satisfied that the applicant had given due preliminary consideration to 

the concerns put forward but requested that these safety mitigation measures and requirements 

should be fully detailed in the operating manual presented for any Final Approval. 

2.13 (Q) Pressure monitoring/control – The Group noted that when treatment stops, the 

storage tank outlet and injection unit inlet valves are to be shut simultaneously by remote control 

for safety and crew protection. However, the Group requested information on what detectors and 

alarms are intended to be fitted for leakage detection of chemicals and/or gases (chlorine) in the 

event of storage tank/system overpressure or excessive temperatures. In particular, information 

was requested on how the supply pipe is to be protected against overpressure if temperature 

exceeds 20o

C. 

2.13.1(A).2 In response, the applicant indicated that even if the temperature of TG Ballastcleaner 

in storage tank exceeds 20o

C, no chlorine gas is generated and only slight amount of oxygen gas 

is generated as stated in 4-1 on page 65 of the “Report on Assessment”. Each of the storage 

tanks are equipped with two pressure/vacuum vent valves, respectively. One of these valves 

opens when tank’s internal pressure exceeds the set pressure value and the other does when the 

internal pressure drops below the set pressure value. In order to avoid overflow from the tank in 

filling TG Ballastcleaner and manage the supply of chemicals, the tank system is equipped with a 

high-level alarm and liquid surface level gaze. 

2.13.2(R) Whilst recognizing the validity of this response, the Group considered that further 

verification of this should be made during the ship board testing and included in the 

documentation for Final Approval. 

2.14(Q) Missing toxicity data for treated ballast water – The Group noted that, for the 

toxicity testing of the treated ballast water, only of Early Life Stage for fish and chronic toxicity 

testing for invertebrate and phytoplankton were reported. As G9 clearly requests both acute and 

chronic toxicity testing (5.2.2 of G9), the applicant was asked if there were any additional data 

for toxicity testing. 
GESAMP-BWWG 6/9 

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Page 9 

I:\MEPC\58\2-7.doc 

2.14.1 The Group agreed that, as this system includes a neutralization process just before 

discharge using sodium sulphite, which, although it has a short life has a high toxicity to marine 

organisms but the toxicity testing does not appear to reflect such a potential short-term risk. 

Also the application did not include the results from the simulation model for short term or even 

for the real measurement of degradation rates in natural seawater for sodium sulphite. As a 

result, the applicant was asked how the risk analysis for sodium sulphite can be evaluated without 

these data. 

2.14.2(A) In response, the applicant stated that it did not have any additional data for toxicity 

tests, because the early life stages of fish and chronic toxicity testing for invertebrate and 

phytoplankton are most sensitive organisms. IDEA consultants Inc. understand that the result 

satisfies the G9 guideline. IDEA stated that “Combining the toxicity results on the test 

organisms, the simulated ballast water to which the test group treated with 30mg/L of residual 

chlorine was exposed had no lethal or sublethal effects in the early life stages of Java medaka

and on the bodies of juvenile marine gammarids (Hyale barbicornis).” on page 97 of the “Report 

on Assessment” 

2.14.3 The degradation rate is the very important parameter. If a low degradation rate is 

assumed, the PEC/PNEC ratio exceeds 1.0 but according to our experiments, sodium sulphite 

becomes sodium sulphate in the treated ballast water within 15 minutes as stated on page 85 of 

the “Report on Assessment”. 

2.14.4 The most sensitive data, EC50 of 16 – 32 mg/l in 6.4 – 8.9h on page 90 of the “Report on 

Assessment” was taken from IUCLID DATASET. But we consider that these data have been 

obtained in an irregular procedure, so we are searching for the original literature. 

2.14.5 The additional tests regarding the DO decrease due to sodium sulphite and its biological 

effect have been planned and already started. So far we have obtained data those show no effects 

on DO. 

2.14.6(R) Having considered these additional clarifications, the Group was still of the opinion 

that the acute toxicity testing for treated ballast water is needed and that the information for acute 

toxicity testing by simulated ballast water was not provided in the dossier. 

2.14.7 The Group recalled that G9 clearly requests both the acute and chronic toxicity testing 

and in this particularly system, there is potential short-term risk from sodium sulphite just around 

the discharge point which the applicant had already recognized. Furthermore, the Group recalled 

that the procedure to control the dose of neutralizer (sodium sulphite) had not been clearly 

described in the dossier, so there were possibilities that the neutralizer was dosed at higher levels 

than required to neutralize the TRC. This would result in residual sodium sulphite being 

discharged to the receiving water before efficient degradation (i.e. 15 minutes). The Group 

recommended that acute toxicity testing using with adequate simulation procedure should be 

performed in a laboratory scale and full scale land-based system for evaluation. In addition, 

the Group requested that quantification analysis and degradation rates of sodium sulphite in 

various conditions should be carried out for the submission for Final Approval. 
GESAMP-BWWG 6/9 

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Page 10 

I:\MEPC\58\2-7.doc 

2.15(Q) HES The Group drew the applicant’s attention to the fact that the Human Exposure 

Scenario (HES) had not been completed. 

2.15.1(A) The applicant indicated that, if allowed to proceed to the application 

for Final Approval, then the following scenarios would be provided in accordance with the 

methodology of specific operation procedure of the ballast water management system: 

 .1 Loading of chemicals 

 .2 Ballasting operation 

 .3 De-ballasting operation 

 .4 Inspection and maintenance of storage tanks 

 .5 Inspection and maintenance of ballast tank 

 .6 Measures for trouble and emergency 

2.15.2(R) The Group encouraged the applicant to develop the relevant human exposure 

scenarios according to HSE methodology. In this context, and in addition to the information 

already provided (e-mail 21/05/08), the Group recommended that the following human exposure 

information related to TG Ballastcleaner should be addressed: 

 .1 in advance identification of all leaking points; these are to be considered critical 

points for the HES (due to the corrosive properties of the preparation); 

 .2 foreseen safety measures for spills/leaks in the waste water collection tank; and 

 .3 manual handheld (residual chlorine meter) measurements of residual chlorine 

concentration in the waste water tank. 

2.16 Q) Lower LODs for disinfection by-products – The Group considered that 

the Level of Quantification (LOQ) for the methods used in the analyses of disinfection 

by-products in treated ballast water were too high. It was pointed out that it is common to 

determine these contaminants in surface waters at levels of 0.1 μg/L. The potential levels may 

therefore be understated, but may as well remain within acceptable limits. Therefore, it remains 

to be confirmed that the potential amount of by-products produced by the system is sufficiently 

low and meets the international standards on these substances. The applicant was requested to 

clarify this uncertainty with additional analyses during the full scale testing on land and/or 

on board ships by the applicant.

2.16.1(A) .15.1 The applicant indicated that it agreed with these concerns and so would ask the 

certified laboratories of chemical analysis to quantify these contaminants in surface water at 

levels of 0.1μg/L hereafter. 

2.16.2(R) The Group noted this response. 

2.17 In addition to these concerns, the Group noted that the applicant had identified a number 

of chemicals which might be produced by the system. Of these, eleven had been identified as 

potentially requiring aquatic toxicity evaluation one of which (sodium sulphite) was also 

identified as requiring mammalian toxicity evaluation. However, the Group noted that the 

applicant did not provide any information on dihalogenated hydrocarbons and chloroamines 

potentially formed during treatment. In addition, the applicant had indicated that two chemicals 

(sodium hypochlorite and sodium sulphate) required mammalian toxicity evaluation only because 

these would be neutralized by sodium sulphite prior to being released in the environment. 
GESAMP-BWWG 6/9 

ANNEX 5 

Page 11 

I:\MEPC\58\2-7.doc 

2.18 The Group expressed the following concerns related to the applicant’s decisions to select 

chemicals for evaluation: 

 .1 sodium sulphite: The applicant indicated that it was not necessary to test this for 

chronic aquatic toxicity as it reacts with residual chlorine and dissolved oxygen; 

 However, it was noted that the applicant had indicated that the theoretical 

maximum concentration in treated ballast water was 22 mg/L. However, it was 

also noted (MEPC 57/2/8, annex, para. 4.6) that residual sodium sulphite reacts 

with naturally occurring dissolved oxygen to become sodium sulphate 

within 10 minutes and so the Group accepted that chronic aquatic toxicity testing 

for this product was not necessary; 

 .2 sodium hypochlorite: The applicant indicated that this was reduced by aquatic 

organisms, organic matter and sodium sulphite. Whilst no indication of the 

completeness and speed of this reaction was given in MEPC 57/2/8, the Group 

noted that the reaction was complete (Report on Assessment of Ballast Water 

Management System that makes use of TG Ballastcleaner and 

TG Environmentalguard, table 3-9-2); 

 .3 residual chlorine: The Group recognized that this would be reduced, during 

discharge by sodium sulphite, as part of the treatment. Whilst no indication of the 

completeness and speed of this reaction was given in MEPC 57/2/8, the Group 

noted that the process was complete (Report on Assessment of Ballast Water 

Management System that makes use of TG Ballastcleaner and 

TG Environmentalguard, table 3-9-2); 

 .4 bromochloroacetic acid: The applicant indicated that this was only generated 

in trace amounts. However, the Group noted that this had been measured at 

0.007 mg/L and so should be evaluated as an Active Substance or Relevant 

Chemical; 

 .5 other haloacetic acids: The Group noted that these had been detected at levels 

up to 0.03 mg/L in treated ballast water and so should be evaluated as 

Active Substances or Relevant Chemicals; and 

 .6 haloacetonitriles: The Group accepted that these chemicals had not been 

detected at levels up to 0.001 or 0.004 mg/L and so need not be evaluated as an 

Active Substance or Relevant Chemical. 

2.19 The Group noted that the following chemicals would be stored onboard as components of 

either TG Ballastcleaner or TC Environmentalguard and should be regarded as Active Substances: 

 .1 sodium hypochlorite (5-13%); 

 .2 sodium hydroxide (<1%); 

 .3 sodium chloride (<13%); 

 .4 sodium sulphite; and 

 .5 sodium sulphate. 
GESAMP-BWWG 6/9 

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I:\MEPC\58\2-7.doc 

2.20 However, the Group: 

 .1 recognized that sodium hypochlorite would be neutralized by sodium sulphite 

prior to discharge to sea and so only required evaluation of the risks to ship’s 

crews and ship safety; 

 .2 agreed that sodium chloride would not present any hazards in storage and would 

be diluted to 0.2% natural seawater concentrations and so need not be subject to 

Risk Assessment; 

 .3 noted that the applicant had provided both aquatic toxicity and mammalian 

toxicity data for evaluation as part of the Risk Assessment; and 

 .4 agreed that sodium sulphate need only be evaluated for its risks to the crew and 

safety of the ship as, when discharged to sea it is at 1% of natural seawater 

concentration. 

3 DESCRIPTION OF THE SYSTEM 

3.1 Overview

3.1.1 This Ballast Water Management System (BWMS) comprises the following modular 

components: 

 .1 the filtration of suspended particles >50μm, during ballasting operations, which 

are then returned to the sea in backwash water; 

 .2 TG Ballastcleaner is added to the ballast water during uptake as a preparation. 

The dosage level of Active Substance was reported as 30mg/l of Free Active 

Chlorine (FAC); and 

 .3 during deballasting, residual chlorine contained in the disinfected ballast water is 

reduced and eliminated by adding TG Environmentalguard (sodium sulphite in the 

ratio of 0.021% to seawater) in order to protect marine habitats in the surrounding 

seawater where the treated ballast water is discharged. The Group expressed 

concern that it was not clear whether the dose rate for the neutralizing solution 

was fixed or could be varied to reflect the level of TRC in the ballast water. This 

issue should be clarified for Final Approval. 
GESAMP-BWWG 6/9 

ANNEX 5 

Page 13 

I:\MEPC\58\2-7.doc 

3.1.2 A schematic representation of the system, provide by the applicant, is shown below: 

3.1.3 Further details of the system, including reference to a cavitation generator, and its 

installation onboard were provided to the Group as confidential information. The Group 

considered that the cavitation phase might affect the composition of chemicals in the ballast 

water and so, in the application for Final Approval, the applicant should indicate that all tests 

were carried out following treatment by ALL parts of the treatment system. 

3.2 Active Substances (AS), Relevant Chemicals (RC) and Other Chemicals (OC)

3.2.1 It was recognized that the Active Substance (sodium hypochlorite), used by this system, 

can react with inherently occurring chemicals to produce by-products, some of which might be 

regarded as Relevant Chemicals. 

3.2.2 However, it was noted that some of these were not detected in the treated ballast water 

and so it was agreed that these need not be evaluated. In addition, it was noted that: 

 .1 the concentration of sodium chloride produced by the system was only 0.2% of 

the natural background concentration in sea water (Section 4-4-1 of the 

confidential “Report on Assessment of Ballast Water Management System that 

Make Use of TG Ballastcleaner and TG Environmentalguard”); 

 .2 the concentration of sodium sulphate produced by the system was 1% of 

the natural background level in seawater (Section 4-4-1 of the confidential 

“Report on Assessment of Ballast Water Management Systems that Make Use of 

TG Ballastcleaner and TG Environmentalguard”); 

 .3 the reactions associated with the degradation of sodium hypochlorite and sodium 

sulphite were as shown below: 

 NaClO + Na2SO3 → NaCl + 2Na2SO4 

 The excess of sodium sulphite becomes sodium sulfate by reacting with dissolved 

oxygen in ballast water by the following reaction: 

 2Na2SO3 + O2 → Na2SO4 

NaClO ...

TG Ballastcleaner TG Environmentalguard 

Ballast 

NaClO 

Na2SO3 Na2SO4

Seawater 

Freshwater 

BALLASTING DEBALLASTING 

Disinfected 

Ballast Water 

Treated Ballast Water 

Ballast Line 

Water Environment 

NaClO Na2SO3

Filter 

Back 

Wash 

Water 
GESAMP-BWWG 6/9 

ANNEX 5 

Page 14 

I:\MEPC\58\2-7.doc 

.4 Hypochlorous acid (See also MEPC 57/2/8, annex, para. 3.1.1): The applicant 

indicated that this was readily reduced with sodium sulphite, as shown in the 

reaction below, and so the Group agreed that this chemical need not be subject to 

a complete Risk Assessment: 

 Na2SO3 + HClO → Na2SO4 + HCl 

 .5 Hypobromous acid (See also MEPC 57/2/8, annex, para. 3.1.1): The applicant 

indicated that this was readily reduced with sodium sulphite, as shown in the 

reaction below, and so the Group agreed that this chemical need not be subject to 

a complete Risk Assessment: 

 Na2SO3 + HBrO → Na2SO4 + HBr 

 .6 Sodium hypobromate (See also MEPC 57/2/8, annex, para. 3.1.1): The applicant 

indicated that this was reduced with sodium sulphite, as shown in the reaction 

below, and so the Group agreed that this chemical need not be subject to a 

complete Risk Assessment: 

 Na2SO3 + NaBrO → Na2SO4 + NaBr

3.2.3 Such chemicals are shown in the table below as shaded 

Substance Chemical 

Formula 

Identification no. Concentration Proposed

Status by 

applicant 

Sodium 

hypochlorite 

described as 

FAC

NaClO CAS no. 7681-52-9 

EINECS no. 231-668-3 

UN no. 1791 

IMCO Class 8.0 

5–13 wt% (as 

FAC) 

AS 

Sodium 

hydroxide 

NaOH CAS no. 1310-73-2 

EINECS no.215-185-5 

UN no. UN1824 

IMCO Class 8.0 

<1 wt% in TG 

Ballastcleaner 

corresponding 

to 12% FAC 

OC 

Sodium 

chloride 

NaCl CAS no. 7647-14-5 Less than 13 

wt% 

corresponding 

to 12% FAC 

OC 

Sodium 

sulphite 

Na2SO3 22 mg/L 

(calculated 

maximum 

concentration) 

OC* 

Sodium 

sulphate 

Na2SO4 

Hypochlorous 

acid 

HClO CAS no. 7790-92-3 --- RC 
GESAMP-BWWG 6/9 

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I:\MEPC\58\2-7.doc 

Substance Chemical 

Formula 

Identification no. Concentration Proposed

Status by 

applicant 

Chloroform CHCl3 CAS no. 67-66-3 0.04 mg/l RC 

Bromodichloro

methane 

CHBrCl2 CAS no. 75-27-4 0.015 mg/l RC* 

Dibromochloro

methane 

CHBr2Cl CAS no. 124-48-1 0.012 mg/l RC* 

Bromoform CHBr3 CAS no. 75-25-2 0.47 mg/l RC* 

Hypobromous 

acid 

HBrO CAS no. 13517-11-8 --- RC 

Sodium 

hypobromite 

NaBrO CAS no. 13824-96-9 --- RC 

Sodium 

bromate 

NaBrO3 CAS no. 7789-38-0 0.0094 mg/l RC* 

Monochloroacetic acid 

CH2ClCOO

H 

CAS no. 79-11-8 0.002 mg/l RC* 

Dichloroacetic 

acid 

CHCl2COO

H 

CAS no. 79-43-6 0.022 mg/l RC* 

Trichloroacetic 

acid 

CCl3COOH CAS no. 76-03-9 0.03 mg/l RC* 

Bromochloroacetic acid 

CHBrClCO

OH 

CAS no. 5689-96-8 0.003 mg/l RC 

Bromodichloro

acetic acid 

CBrCl2COO

H 

CAS no. 71133-14-7 <0.01 mg/l RC 

Dibromochloro

acetic acid 

CBr2ClCOO

H 

CAS no. 5278-95-5 <0.03 mg/l RC 

Bromoacetic 

acid 

CH2BrCOO

H 

CAS no. 79-08-3 0.007 mg/L RC 

Dibromoacetic 

acid 

CHBr2COO

H 

CAS no. 631-64-1 0.055 mg/L RC* 

Tribromoacetic 

acid 

CBr3COOH CAS no. 75-96-7 <0.05 mg/l RC 

Chloroacetonitrile 

CH2ClCN CAS no. 107-14-2 <0.001 mg/l RC 

Dichloroacetonitrile CHCl2CN CAS no. 3018-12-0 <0.004 mg/l RC 

Trichloroacetonitrile CCl3CN CAS no. 545-06-2 <0.001 mg/l RC 

Dibromoacetonitrile CHBr2CN CAS no. 3252-43-5 <0.001 mg/l RC 

Bromochloroacetonitrile CHBrClCN CAS no. 83463-62-1 <0.001 mg/l RC 
GESAMP-BWWG 6/9 

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I:\MEPC\58\2-7.doc 

Substance Chemical 

Formula 

Identification no. Concentration Proposed

Status by 

applicant 

Monochloramine NH2Cl CAS no. 10599-90-3 --- RC 

* = Identified by the applicant for risk evaluation

3.2.4 The Group noted that the applicant had identified the following eleven chemicals as 

either Active Substances or Relevant Chemicals possibly requiring evaluation (MEPC 57/2/8, 

annex, Summary): 

 .1 sodium sulphite (acute toxicity only); 

 .2 sodium bromate; 

 .3 chloroform; 

 .4 bromodichloromethane; 

 .5 dibromochloromethane; 

 .6 bromoform; 

 .7 monochloroacetic acid; 

 .8 dichloroacetic acid; 

 .9 trichloroacetic acid; 

 .10 bromoacetic acid; and 

 .11 dibromoacetic acid. 

3.2.5 However, the Group noted that bromochloroacetic acid might also require some degree of 

evaluation. 

3.2.6 The Group also noted that the applicant: 

.1 had grouped data on some of the products under halomethanes and haloacetic 

acids; 

.2 had concluded that only mammalian toxicity data were needed for sodium 

hypochlorite, sodium sulphite and sodium sulphate 

3.2.7 An indication of the data provided by the applicant for various chemicals is shown in the 

table below: 
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ANNEX 5 

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Data provided for or referenced for chemicals associated with the BWMS 

Chemical Aquatic Ecotoxicity Mammalian Toxicity 

 AE CE ED ST B AMT C/I CT D/R C/M

Sodium 

hypochlorite √ √ √ √ √

F √ R 

C √

Sodium sulphite 

A √

R √ √ √ √ √

Sodium sulphate √ √ √ √ √

Active Substances 

Sodium hydroxide 

Sodium bromate M √

N √ R R √ 

 

Chloroform F √ √

C √ √

A √ √

R R √ 

Bromodichloromet

hane F √

C √

 A 

R R √ 

Dibromochloromet

hane F √

C √

 A 

 

Halomethanes 

Bromoform F √ √

C √

A √ √

R R √ 

Monochloroacetic 

acid √ √ R R √ 

Dichloroacetic acid √ R R √ 

Trichloroacetic acid √ R R √ 

Bromoacetic acid √ √ R R √ 

Bromochloroacetic 

acid 

Haloacetic acids 

Dibromoacetic acid √ R R √ 

Dibromoacetonitril

e 

√ R R √ 

AE = Acute Ecotoxicity 

CE = Chronic Ecotoxicity 

ED = Endocrine Disruption 

ST = Sediment Toxicity 

B = Bioavailability/biomagnification/bioconcentration 

AMT = Acute Mammalian Toxicity 

C/I = Skin/Eye Corrosion/Irritation 

CT = Chronic and Long-term Toxicity 
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D/R = Developmental and Reproductive Toxicity 

C/M = Carcinogenicity and Mutagenicity 

F = Fish 

C = Crustacea 

A = Algae 

R = Property referenced but no data provided 

√ = Data provided 

4 HUMAN HEALTH ASSESSMENT 

4.1 TG Ballastcleaner 

4.1.1 The Group considered sodium hypochlorite to be the critical toxicant in terms of human 

health effects and therefore used this Active Substance to address the hazards of the preparation 

and to further its risk assessment. In this context the Group noted the classification of this 

preparation as shown in the MSDS provided by the applicant: 

 Xi; R36/37/38, R31 

4.1.2 The applicant indicated that there are two versions of the TG Ballastcleaner, one 

with 5-6% of sodium hypochlorite and one with 12-13% of sodium hypochlorite. In accordance 

with current European regulations (directive 1999/45/EC) for classification this would result in 

the two different preparations of TG Ballastcleaner driving two different classifications, the first 

is an Irritant (R31-36/38) and the second one is Corrosive (R31-34) (since the classification limit 

of 10% is exceeded) and so two different SDSs are needed to reflect this. The Group decided for 

its work to use the 13% of sodium hypochlorite as a worst-case scenario. 

4.1.3 For clarification the Group referred to the regulations according to GHS (UNECE, second 

revised edition, 2007) where the following is said under A4.3.11.2 about the information required 

for section 11 of the SDS which states: 

 “The data included in this subsection should apply to the substance or mixture as used. 

The toxicological data should describe the mixture. If that information is not available, 

the classification under GHS and the toxicological properties of the hazardous ingredients 

should be provided.” 

4.1.4 The Group noted that, according to the presented data, as shown in the table below, the acute 

toxicity of sodium hypochlorite is low by the oral, dermal and inhalation routes of exposure. 

Acute toxicity 

Route of exposure Species Effect Reference 

Oral 

(12.5% sodium hypochlorite) 

Rat LD50> 5.8 g/kg bw RAR EC, 2007

Dermal 

(unspecified concentration sodium 

hypochlorite) 

Rabbit LD0> 10 g/kg bw () RAR EC, 2007

Inhalation 

(unspecified concentration sodium 

hypochlorite) 

Rat LC0>10.5 mg/l (1h) RAR EC, 2007
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4.1.5 The Group noted that, according to the presented data, shown in the following two tables, 

sodium hypochlorite (12.7%) a moderate skin irritant and a severe eye irritant 

4.1.6 The Group also noted that, according to RAR EC (2007), corrosivity from animal studies 

show that 12.7% of hypochlorite solution produced severely irritant or corrosive effects to the 

eye. However the same concentration applied to rabbit skin does not show corrosive effects, 

only moderate irritation was observed. Sodium hypochlorite aerosols may be irritant to the 

respiratory tract. 

4.1.7 The Group agreed that the overall evaluation of both animal and human data supports the 

current EU classification as irritant above 5% and as corrosive above 10% which is pertinent to 

the hazards to be expected with TG Ballastcleaner. 

Skin irritation 

Substance Species Exposure 

duration 

Effect Reference 

Sodium hypochlorite 

12.7% 

(as FAC) 

Rabbit 24 hours Intact skin and abraded 

skin. Result: Moderately 

irritating 

RAR EC, 2007 

Eye Irritation 

Substance Species Exposure 

duration 

Method Effect Reference 

Sodium 

hypochlorite 

12.7% 

(as FAC) 

Rabbit 14days Draize 

method 

Severely 

irritating. 

Recovery not 

complete at 

14 days 

RAR EC, 2007 

4.1.8 Sensitization – The Group noted that, according to existing data, sodium hypochlorite 

does not show a potential to cause delayed contact hypersensitivity (draft Risk Assessment 

Report (RAR) on sodium hypochlorite, EU Assessment 793/93). 

4.1.9 Repeated Dose Toxicity – The Group noted the repeated dose toxicity data shown in the 

table below and the NTP, 1992 which is considered to be the key study for deriving a NOEL for 

risk characterization for the oral route. 

4.1.10 Concerning the repeated exposure by dermal route, EC (RAR, 2007), the NTP concluded 

that no systemic effects were seen following dermal exposure to 10000mg/L NaClO. A NOEL 

of 1% from the study of Kurokawa (1984) is chosen to evaluate the local dermal effects. 
GESAMP-BWWG 6/9 

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4.1.11 For the evaluation of the effects of inhalation exposure, it is proposed to use data from 

chlorine gas. The NOAEL for repeated exposure to chlorine gas is 0.5 ppm in studies performed 

with rhesus monkeys and human volunteers. 

Substance Species Dose/route of 

exposure 

Duration 

of 

treatment 

Effects Reference 

Sodium 

hypochlorite 

SpragueDawley 

rats 

Drinking-water 

0, 3, 10, 16 or 

21 mg/kg bw 

per day as FAC 

90 days NOEL of 10 mg/kg 

bw based on 

reduced body 

weight gain 

Daniel et al., 

1990 (EHC, 

2000) 

Sodium 

hypochlorite 

B6C3F1 

Mice 

Drinking water 

0, 70, 140 and 

275 mg/L as 

FAC 

2 years NOEL 13.75 mg/kg 

bw (or 275 mg/l as 

FAC) 

No treatment 

related adverse 

effects were 

observed 

NTP, 1992 

4.1.12 Carcinogenicity/Mutagenicity – The Group noted that sodium hypochlorite is not 

classified by IARC as to its carcinogenicity to humans (Group 3). Several studies have shown 

that sodium hypochlorite produces mutagenic responses in bacterial systems and mammalian 

cells in vitro. However, there is no evidence of activity in mammalian test systems in vivo. 

4.1.13 In conclusion, based on the results of the effects assessment of sodium hypochlorite, 

the Group considered that the human health hazards of TG Ballastcleaner (up to 13% NaClO) are 

due to its corrosive properties. 

4.1.14 Therefore, the Group recommended that engineering measures are put in place in 

addition to the use of PPE/RPE in order to minimise human exposure. 

4.2 THM generation in conjunction with TG Ballastcleaner 

4.2.1 The Group considered that chlorinated and brominated disinfection by-products (THM) 

are the toxicological relevant compounds generated by the preparation as they have a potential 

for human genotoxicity/carcinogenicity. According to WHO Guidelines for Drinking Water 

Quality, 2003, these compounds have to be kept under toxicological critical levels 

(e.g., bromate <10μg/L; bromoform <100μg/L; chloroform <200 μg/L). 

4.2.2 Acute toxicity of trihalomethanes – The Group noted that the Acute toxicity (LD50) of 

trihalomethanes (Chloroform, Bromodichloromethane, dibromochloromethane and bromoform) 

on 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. 

4.2.3 The Group also noted that chloroform (GHS classification, Annex VI, COM (2007) 355 

final), bromodichloromethane and chlorodibromomethane (self classification by commercial 

suppliers) are all classified as harmful if swallowed. However, it was noted that bromoform is 

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

bromate (as potassium bromate) is classified as toxic if swallowed (GHS classification, 

Annex VI, COM (2007) 355 final). 
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4.2.4 Genotoxicity/Carcinogenicity – The Group noted that chloroform and other THMs 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). 

4.2.5 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). 

4.2.6 Chloroform is classified according to its carcinogenic properties (suspected of causing 

cancer) (GHS classification, Annex VI, COM (2007) 355 final), this conclusion also applies for 

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). 

4.3 HAA generation in conjunction with TG Ballastcleaner

4.3.1 The Group noted that: 

 .1 monochloroacetic acid is classified according to GHS as acute tox 3 (ingestion), 

and as skin corr 1 B (hazard statements; H301 and H314); 

 .2 dichloroacetic acid is classified according to GHS as skin corr 1 A 

(hazard statement; H314); 

 .3 trichloroacetic acid is classified according to GHS as skin corr 1 A 

(hazard statement; H314); 

 .4 monobromoacetic acid is classified according to GHS as acute tox 3 (inhalation, 

skin contact, ingestion, and as skin corr 1 A (hazard statements; H331, H311, 

H301 and H314); and 

 .5 dibromoacetic acid is classified according to GHS (self-classification according to 

supplier) as acute tox 3 (inhalation, skin contact, ingestion, and as skin corr 1 B 

(hazard statements; H331, H311, H301 and H314). 

4.4 TG Environmentalguard 

4.4.1 The Group noted that the classification of the preparation which was stated to be in 

accordance with the current European system for classification and labelling, according to the 

MSDS (TG Environmentalguard, first issue May 1, 2007), provided by the applicant was: 

 Xi; R36/37/38, R31 

4.4.2 However, the Group also noted that the SDS presented by the applicant for 

the TG Environmentalguard is not accurate since the basis for classification as Irritant is lacking. 

(The Group noted that according to self-classification by major suppliers in Europe the two 

active substances in TG Environmentalguard are regarded as non-classified and only slightly 

irritating by oral route, skin contact as well as by inhalation). Section 11 of the supplier SDS 

confirms that this preparation is to be regarded as slightly irritating. Yet, in section 15, the 

above-mentioned classification is presented without any justification. 
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4.4.3 According to the presented data, the Group agreed that sodium sulphite is not an acute 

toxicant by oral route, neither is it considered to be an eye or skin irritant. Furthermore there 

seemed to be neither any relevant toxicological concerns towards repeated exposure to sodium 

sulphite nor to its developmental toxicity or mutagenicity. 

4.4.4 In addition, the Group noted that sodium sulphite is classified as IARC group 3 

(Not classifiable as to its carcinogenicity) since no data were available on the carcinogenicity in 

experimental animals of sulphites. Evaluation by IARC states that there is inadequate evidence

for the carcinogenicity in experimental animals of sulphites. 

4.4.5 According to the presented data, sodium sulphate is not considered to be an acute toxicant 

by oral route, neither is it considered to be an eye or skin irritant. Furthermore there seemed to be 

neither any relevant toxicological concerns towards repeated exposure to sodium sulfate nor to 

developmental toxicity, mutagenicity or carcinogenicity. 

4.4.6 In conclusion, based on the results of the effects assessment of sodium sulphite and 

sodium sulphate, the Group considers that the hazardous properties of TG Environmentalguard 

are slight irritation. Therefore, the Group recommended that engineering measures are put in 

place in addition to the use of PPE/RPE in order to minimize human exposure. 

4.5 Human Exposure Assessment based on HES 

4.5.1 The Group encourages the applicant to proceed the building up of the HES for the BWTS 

according to human exposure assessment methodology, therefore being able to identify the tasks 

that may pose a risk to human health and if necessary to elaborate a proposal for RMM. 

4.5.2 In this context, and in addition to the information already forwarded by the Applicant 

(e-mail 21/05/08), the Group added the following requirements for TG Ballastcleaner when being 

submitted for Final Approval: 

 .1 all leaking points should be identified in advance and considered critical points for 

the HES (due to the corrosive properties of the preparation); 

 .2 foreseen safety measures for spills/leaks in the waste water collection tank 

(2.5 parts of TG Environmentalguard and 1 part of TG Ballastcleaner); and 

 .3 manual handheld (residual chlorine meter) measurements of residual chlorine 

concentration in the waste water tank. 
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5 RISKS TO THE SAFETY OF THE SHIP, ITS CREW AND THE GENERAL 

PUBLIC

5.1 Storage and handling of preparations 

5.1.1 The Group considered that the most relevant risk to human health associated with the 

onboard storage of the preparation TG Ballastcleaner (up to 13% NaClO) is due to its corrosive 

properties. Therefore, the Group recommended that, in addition to the use of PPE/RPE, risk 

reduction features should be incorporated into the system design specification so as to minimize 

the possibilities of human exposure.. 

5.1.2 The Group considered that the hazardous properties of TG Environmentalguard are slight 

irritation based on the results of the toxicological evaluation of sodium sulphite and sodium 

sulphate. Therefore, the Group recommended that engineering measures are put in place in 

addition to the use of PPE/RPE in order to minimise human exposure. 

5.1.3 The Group recommended that the storage arrangements for the substances involved are 

verified as fully compliant with all relevant maritime regulations and Codes for the storage and 

carriage of such preparations, including the location of the storage facilities and PPE and risk 

mitigation measures required. 

5.1.4 The Group further recommends that the procedures for the loading and handling of the 

preparations are fully detailed in the operations manual, including all PPE and safety 

considerations necessary for safe handling. 

5.2 Chlorine Gas 

5.2.1 The Group considered that there is a small possibility that the use of this ballast water 

treatment system may result in an accumulation of chlorine gas in the treated ballast tanks. 

This possibility should be considered and monitored during onboard testing to ensure that 

chlorine gas accumulation in the ballast tanks will not raise a risk to the crew. 

5.3 Corrosion 

5.3.1 The Group considered that the data submitted regarding TG Ballastcleaner indicate it to 

be corrosive to steel both in the concentrate and the treated ballast water concentrations. 

The Group noted that the supplemental material stated that: 

.1 the treatment with TG Ballastcleaner is corrosive to steel, ballast and supply 

piping and storage tanks; 

.2 such treatment contact surfaces should be coated (tanks) with an epoxy resin 

coating system or lined (pipes) with polypropylene, polyvinylchloride or 

polyethylene or constructed of Titanium or its alloys; and 

.3 the Handling Manual additionally recognizes that gasket materials used in the 

injection piping must be sufficiently resistant. 
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5.3.2 At the request of the Group regarding long-term corrosion evaluations, the applicant 

submitted additional data regarding long term coatings studies reported in appendixes 1-2 of the 

supplemental material, entitled ”Endurance Tests of Epoxy coated steel with Simulated Fault”. 

This effort evaluated the effects of sodium hypochlorite and hydrogen peroxide on coated steel 

coatings adhesion. The relevant portion of the document reports: 

 .1 a 100-day, ten-cycle alternate immersion study of coal tar epoxy and modified 

epoxy coated steel substrates conducted; 

 .2 each sample was tested in duplicate and was applied with a 40 mm cross-cut 

scribe which penetrated the coating; 

 .3 each cycle included a 7-day immersion period and a 3-day dry period; 

 .4 the immersion portion of the cycle included a either artificial seawater or artificial 

seawater with an initial dose of either 20 mg/L sodium hypochlorite or a 50 mg/L 

dose of hydrogen peroxide or a natural seawater. The test solution was newly 

prepared for each cycle; 

 .5 the TRO was recorded at the beginning and end of each test cycle, TRO 

concentrations varied from 18-23 mg/L and generally < 1 mg/L at the beginning 

and end of the cycle, respectively; 

 .6 the samples were evaluated for appearance, coatings adhesion of the scribed area 

and the unperturbed coating according to JIS K 5400 and coating hardness 

according to pencil hardness test, JIS K 5600; 

 .7 from the visual appearance of samples coated with a modified epoxy coating 

(typical for use in the marine vessel industry), samples exposed to sodium 

hypochlorite had more apparent corrosion, judged by the presence of corrosion 

products, and some discoloration of the coating had occurred. However, the 

applicant notes that no blistering or exfoliation of the scribed area and the coating 

remained intact. No penetration depths or corrosion rates were measured to assess 

the relative increase in corrosion rate in 20 mg/L TRC seawater. The Group noted 

from the provided photographs that the scribed area of the coating exhibited 

substantially more corrosion products and rust staining, as compared to the 

artificial seawater exposure which reflected only discrete corrosion products along 

the scribe; 

.8 regarding coatings adhesion testing subsequent to testing in the respective test 

conditions, the adhesion strength deteriorated about 3.4% for the condition in 

which 20 mg/L of sodium hypochlorite was added versus a deterioration of 

about 1.9% in artificial seawater. As a result, the applicant concluded that although 

there was a tendency towards deterioration there were no significant differences; 

.9 evaluation of the scribed area coating adhesion through a cellophane tape peel test 

revealed no coatings exfoliation in any case; 

.10 with the modified epoxy paint, lower (softer) results were obtained compared to 

the untested material for all test solution conditions, but the results were similar 

for the artificial sea water. In other words, with the modified epoxy paint, there 

was a tendency towards softening with the passing of test time regardless of 

sodium hypochlorite presence; 
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.11 From these test data, the applicant concluded the following: 

.11.1 For the modified epoxy paint, discoloration occurred for the condition in 

which 20 mg/L of sodium hypochlorite was added; 

.11.2 Although there were differences in the degree of rusting for the cross cut 

parts of the modified epoxy paint, the coat film in the vicinity of the cross 

cut was in sound condition; 

.11.3 For the adhesion strength of the cross cut parts after the tests no peeling of 

the coat film could be noticed; and 

.11.4 from the pencil hardness test and the adhesion strength test no significant 

differences could be noticed between the artificial seawater solutions with 

and without 20 mg/L sodium hypochlorite was added. 

5.3.3 The Group agreed that: 

.1 the marine coatings evaluation study conducted by the applicant was useful and 

significant in evaluating the impact of 20 mg/L TRO concentration seawater on 

conventional marine epoxy coatings. In addition, the Group accepted from these 

studies the conclusion that conventional epoxy systems shall be sufficiently 

protective in 20 mg/L TRO concentration treated seawater. However, as the 

proposed treatment concentration of the TG Ballastcleaner is 30 mg/L, these data 

may only be indicative of likely performance; 

.2 with regards to corrosion of carbon steel, the applicants results and conclusions 

make it apparent that increased corrosion rate may be expected, but their studies 

did not sufficiently assess or quantify the expected corrosion rate of carbon steel. 

Also, as the proposed treatment concentration of the TG Ballastcleaner 

is 30 mg/L TRO, these data may only be indicative of likely substrate corrosion 

effects since they were carried out at 20 mg/L TRO; 

.3 the applicant did not provide either literature or test data which quantify the extent 

of corrosion on either relevant metallic or non-metallic materials. While the need 

for epoxy coatings within the ballast tanks is recognized, it cannot be expected 

that ballast tanks will be maintained with a defect free coating systems as ship 

tanks can be expected to have exposed substrates of up to 15% of the coated 

surface; and 

.4 with respect to non-metallic materials, it is known that TRO exceeding 1 mg/l can 

cause degradation of some non-metallic materials commonly used as gaskets or 

sealing materials, but the applicant does not address this concern. 

5.3.4 The Group recommended that the long term studies, as appropriate, be carried out or 

otherwise documented from literature to quantify, at the treatment concentration, the expected 

uniform or localized corrosion rates on typical marine vessel metallic (e.g., steel, galvanized 

steel, zinc, stainless steel, etc...) and non-metallic materials (e.g., EPDM rubber) used for ballast 

tanks, fixtures and piping. Studies of the same rigor and approach of those submitted for the 

coatings effects are encouraged using methods which are applicable for the direct measurement 

and quantification of corrosion rates or material degradation. 
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5.4 Other concerns 

5.4.1 The Group noted that this system requires the onboard storage of solutions containing 

sodium hypochlorite, sodium hydroxide, sodium chloride, sodium sulphite and sodium sulphate. 

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

TOXICITY (T)

6.1 The Group noted that the following classifications could be made on the PBT-Criteria as 

presented in the table below: 

Substance for PBT criteria Persistence (P) 

(Yes or No)

Bioaccumulation (B) 

(Yes or No)

Toxicity (T) 

(Yes or No)

Trihalomethanes Yes No No 

Sodium bromate Yes No No 

Haloacetic acids Yes No No 

Haloacetonitoriles Yes No No 

Sodium sulphite No No No 

6.2 Based on the results of table 6.1 the Group concluded that these chemicals should not be 

classified as PBT-substances. 

7 ENVIRONMENTAL RISK ASSESSMENT

7.1 The Group noted that the applicant had used the MAM-PEC model to estimate the 

Predicted Environmental Concentrations of the various chemicals in the Port of Rotterdam. 

7.2 From the data generated by the MAM-PEC model and the aquatic toxicity data associated with 

various Relevant Chemicals, the Group agreed on the PEC/PNEC ratios shown in the table below. 

Calculation of the PEC/PNEC Ratios 

Toxicity Value PNEC BW 

conc. 

Dil. 

factor 

PEC PEC/P

NEC 

Chemical substance 

Endpoint Conc. 

(mg/l) 

Assess 

ment 

factor (μg/l) (μg/l) 

Chloroform (freshwater) EC50 72h 13.3 1000 13.3 40 58 0.69 0.052 

Chloroform (seawater) LC50 96h 28 1000 28 40 58 0.69 0.025 

Bromoform (freshwater) LC50 96h 29 1000 29 470 145 3.24 0.11 

Bromoform (seawater) LC50 96h 7.1 1000 7.1 470 145 3.24 0.46 

Monochloroacetic acid EC50 48h 0.028 1000 0.028 2 252 0.008 0.28 

Trichloroacetic acid EC50 96h 0.3 1000 0.3 30 102 0.294 0.98 

Bromoacetic acid EC50 72h 0.2 1000 0.2 7 58 0.121 0.61 

Sodium sulphite EC50 6.4-

8.9h 

25.2 100 252 22000 67600 0.33 0.0013
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7.3 The Group found that the assessment factor of 100 for the acute aquatic toxicity of 

sodium sulphite was not regarded as sufficient and the lowest EC50 was found to be 16 instead 

of 25.2 mg/L (Table 3.2.1.6, MEPC 57/2/8). According to the Methodology an assessment factor 

of 1000 would have to be applied for an acute aquatic toxicity value. However, even with an 

assessment factor of 1000 and application of the lower EC50 the PEC/PNEC remains well below 1. 

8 CONCLUSIONS AND RECOMMENDATIONS 

8.1 Risks to the safety of the ship

8.1.1 The Group agreed that providing the precautions referred to under section 5, are adhered 

to, there should be no undue safety concerns for the ship while the additional work is carried out 

to allow an application for Final Approval to be made. 

8.2 Risks to the crew and general public 

8.2.1 Having considered the hazards and risks associated with the onboard storage 

of TG Ballastcleaner and TG Environmentalguard, the Group concluded that the major human 

health risk associated with the system is related to the corrosive properties of TG Ballastcleaner 

(up to 13% NaClO). Therefore, the Group recommended that engineering measures are put in 

place in addition to the use of PPE/RPE in order to minimise human exposure. 

8.2.2 The Group encouraged the applicant to proceed in the building up of the relevant human 

exposure scenarios according to HES methodology. In this context and in addition to the 

information already provided (e-mail 21/05/08), the Group recommended that following human 

exposure information related to TG Ballastcleaner should be addressed: 

 .1 in advance identification of all leaking points; these are to be considered critical 

points for the HES (due to the corrosive properties of the preparation); 

 .2 foreseen safety measures for spills/leaks in the waste water collection tank; and 

 .3 manual handheld (residual chlorine meter) measurements of residual chlorine 

concentration in the waste water tank. 

8.3 Risks to the environment 

8.3.1 Based on the information provided, the Group agreed that there would be no undue risks 

to the environment while the necessary work is being undertaken to make an application 

for Final Approval. 

8.4 Recommendations 

8.4.1 Having considered all of the data submitted for Basic Approval, the Group agreed to 

recommend to MEPC that Basic Approval be granted to this system. 
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8.4.2 When applying for Final Approval in the future, the following subjects need to be 

addressed carefully: 

 .1 Considering corrosion, the Group agreed that the applicant’s response was 

insufficient to quantitatively assess the corrosion impact to relevant metallic and 

non-metallic materials likely to be used in ballast water tanks, piping and fixtures. 

For non-metallic gasket materials, the applicant responded that tests were not 

started since they have sufficient information for suitable materials but no details 

or data were provide. 

 .2 The applicant should provide appropriate QAs and QCs and indicate why there are 

different detection limits for the same substance being analysed. 

 .3 Further measurement and analysis of discharge concentration of THMs and HAAs 

with adequate QA/QC should be taken during the full scale land-based test before 

the submission of final approval. 

 .4 The chemical analyses for THMs were not performed under adequate QAPPs and 

so recommended that all chemical measurement and analyses should be performed 

under QAPPs. 

 .5 Final Approval submission should provide full details of the dosing control 

arrangements so as to ensure certainty of maintaining specified dosage levels of 

Active Substances. 

 .6 The Group was satisfied that the flow diagram, provided, was suitable for 

Basic Approval. It is appreciated that further details for evaluation be supplied for 

review during any Final Approval. 

 .7 The applicant indicated to continue gathering information related to the 

two chemicals, bromochloroacetic acid and bromodichloroacetic acid and, if no 

additional data were to be found, they would carry out further algal tests as 

required. 

 .8 The Group was satisfied that the applicant had given due preliminary 

consideration to the concerns concerning temperature control put forward but 

requested that these safety mitigation measures and requirements should be fully 

detailed in the operating manual presented for any Final Approval. 

 .9 Whilst recognizing the validity of the pressure monitoring/control, the Group 

considered that further verification of this should be made during the ship board 

testing and included in the documentation for Final Approval. 

 .10 The Group is of the opinion that the acute toxicity testing for treated ballast water 

is needed and that the information for acute toxicity testing by simulated ballast 

water in a laboratory scale and full scale land-based system for evaluation. 

In addition the Group requested that quantification analysis and degradation rates 

of sodium sulphite in various conditions should be carried out for the submission 

for Final Approval. 
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 .11 The Group recommended that the following human exposure information related 

to TG BallastCleaner should be addressed: 

 .1 in advance identification of all leaking points; these are to be considered 

critical points for the HSE (due to the corrosive properties of the 

preparation); 

 .2 foreseen safety measures for spills/leaks in the waste water collection tank; 

and 

 .3 manual handheld (residual chlorine meter) measurements of residual 

chlorine concentration in the waste water tank. 

* * * 
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Appendix 5.1 

Chemical and biological properties of Trihalomethanes 

1 CHEMICAL IDENTIFICATION

1.1 Various data were presented on the following chemicals included in this group: 

 .1 chloroform; 

 .2 bromodichloromethane; 

 .3 dibromochloromethane; and 

 .4 bromoform. 

1.2 However, it was noted that no data had been provided for dibromochloromethane which 

had been identified in concentrations similar to that of bromodichloromethane. 

1.3 The chemical formulae and identification numbers are shown in paragraph 3.2.5 of the 

main section of this report. 

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

Substance Type/Organism Endpoint Concentration 

(mg/l) 

Reference 

Fish (Freshwater) 

(Lepomis macrochirus) 

LC50 96h 18 IUCLID 

Fish (seawater) 

(Limanda limanda)

LC50 96h 28 as above 

Crustacean (Freshwater) 

(Daphnia magna) 

EC50 48h 29 as above 

Crustacean (seawater) 

Brine shrimp 

(Artemia salina) 

EC50 24h 30.37 G.D. Foster et al.

(1984) 

Phytoplankton (Freshwater) 

(Chlamydomonas reinhardtii)

EC50 72h 13.3 IUCLID 

Chloroform 

Aquatic Plant (seawater) 

Diatom (Skeletonema 

costatum) 

EC50 120h 437 as above 

Fish 

Common carp 

(Cyprinus carpio) egg 

EC50 

72-120h 

67.4 J.S. Mattice et al.

(1981) 

Bromodichloromethane 

Crustacean 

Ciliate 

(Tetrahymena pyriformis) 

EC50 24h 240 Y. Yoshioka et al.

(1985) 

Dibromochloromethane Fish 

Common carp 

(Cyprinus carpio) egg 

LC50 72-

120h 

33.5 J.S. Mattice et al.

(1981) 
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Substance Type/Organism Endpoint Concentration 

(mg/l) 

Reference 

 Crustacean 

Ciliate 

 (Tetrahymena pyriformis) 

EC50 24h 65 Y. Yoshioka et al.

(1985) 

Fish (Freshwater) 

Bluegill (Lepomis 

macrochirus) 

LC50 96h 29 R.J. Buccafusco et al.

(1985) 

Fish (Seawater) 

Sheepshead minnows 

(Cyprinodon variegatus) 

LC50 96h 7.1 G.S. Ward et al.

(1981) 

Crustacean (Freshwater) 

Water flea (Daphnia pulex) 

LC50 96h 44 J.R. Trabalka et al.

(1977) 

Crustacean (Seawater) 

Brown Shrimp 

(Peaneus aziecus) 

LC50 96h 26 ECOTOX 

Phytoplankton (Freshwater) 

Green algae 

(Selenastrum capricornutum) 

EC50 96h 38.6 PAN Pesticides 

Database 

Bromoform 

Phytoplankton (Seawater) 

Diatom 

(Skeletonema costatum) 

EC50 96h 12.3 ECOTOX 

2.2 Chronic Aquatic Toxicity Data

2.2.1 The Group noted that the applicant had identified the species which was most sensitive to 

each of the chemicals and had provided chronic toxicity data for each species/chemical 

combination. 

Substance Type/Organism Endpoint Conc. 

(mg/l) 

Reference 

Chloroform Fish 

(Oncorhynchus mykiss)

LC50 27d 2.03 IUCLID 

 Crustacean 

(Daphnia magna)

NOEC 

21d 

13 as above 

 Phytoplankton 

Diatom 

(Skeletonema costatum) 

NOEC 5d 216 U.M. Cowgill 

et al. (1989) 

Bromoform Fish 

Sheepshead minnow (Cyprinodon 

variegatus) 

NOEC 4d 2.9 P.T. Heitmuller 

et al. (1981) 

 Mollusk Littleneck clam (Protothaca 

staminea) 

Not 

reported 

7 C.I. Gibson et al.

(1979) 

NUREG/CR0835 PNL-3023 

 Phytoplankton Green algae 

(Selenastrum capricornutum) 

NOEC 4d 10 Pan Pesticides 

Database 

Bromodichloromethane No data provided 

Dibromochloromethane No data provided 
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2.3 Information on Endocrine Disruption

2.3.1 The Group noted that the applicant had been unable to find any information on the 

endocrine disruption potential of trihalomethanes. 

2.4 Sediment Toxicity

2.4.1 The Group [noted][concurred with the applicant] that the evaluation of the effects on 

benthic organisms was unnecessary for trihalomethanes as the absorption coefficient of all 

chemicals in this group are <500 l/kg. 

2.4.2 However, the Group indicated that it would have preferred to see specific values 

identified rather than be described as “<500 l/kg”. 

2.5 Bioavailability/Biomagnification/bioconcentration

2.5.1 The Group noted the following log Pow and calculated BCF values for trihalomethanes 

and recognized that, as they were all <3, the bioaccumulation potential of these compounds is 

expected to be low. 

Chemical substance Log Pow BCF (l/kg) Reference 

Relevant Chemicals 

Chloroform 1.52 1.7 Syracuse Research Corporation, 

Bromodichloromethane 1.61 2.0 Syracuse Research Corporation, 

Dibromochloromethane 1.70 2.4 Syracuse Research Corporation, 

Bromoform 1.79 2.8 Syracuse Research Corporation, 

3 MAMMALIAN TOXICITY 

3.1 The Group noted that no mammalian toxicity data had been provided for the group 

of Trihalomethanes. 

3.2 However, the Group recalled that it had been considered necessary to review the 

toxicology of some THM generated by other systems and considered that such a review was 

necessary for this system (please see section 4 of the Report). 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic) 

 Sea 

water or 

Fresh 

Water 

Test 

Duration 

Results Break-down 

products 

Reference/Comments/ 

Justification for 

missing data 

1/2-Life Seawater NR >60days MEPC 57/2/8, annex, 

para. 4.3 
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4.2 Partition Coefficients

Chemical substance log Pow BCF (l/kg) Reference 

Relevant Chemicals 

Chloroform 1.52 1.7 Syracuse Research Corporation 

Bromodichloromethane 1.61 2.0 Syracuse Research Corporation 

Dibromochloromethane 1.70 2.4 Syracuse Research Corporation 

Bromoform 1.79 2.8 Syracuse Research Corporation 

4.3 Persistence and Identification of Main Metabolites

4.3.1 No information provided. 

4.4 Reaction with Organic Matter

4.4.1 No information provided.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats 

4.5.1 No information provided. 

4.6 Potential Residues in Seafood

4.6.1 No information provided. 

5 PHYSICAL PROPERTIES

5.1 No physical property data were provided for this group of chemicals. 

6 OTHER INFORMATION

6.1 Analytical Methods for Measuring the Concentration at Environmentally Relevant 

Concentrations

6.1.1 No information provided. 

6.2 Material Safety Data Sheet provided: No 

6.3 GHS Classification Not provided 

6.4 Risk Characterization

Substance for PBT criteria Persistence (P) 

(Yes or No)

Bioaccumulation (B) 

(Yes or No)

Toxicity (T) 

(Yes or No)

Trihalomethanes Yes No No 

* * * 
GESAMP-BWWG 6/9 

ANNEX 5 

Page 34 

I:\MEPC\58\2-7.doc 

Appendix 5.2 

Chemical and biological properties of Haloacetic acids and Haloacetonitriles 

1 CHEMICAL IDENTIFICATION

1.1 Various data were presented on the following chemicals included in this group: 

 .1 monochloroacetic acid; 

 .2 dichloroacetic acid; 

 .3 trichloroacetic acid; 

 .4 bromoacetic acid; and 

 .5 dibromoacetic acid. 

1.2 The chemical formulae and identification numbers are shown in paragraph 3.2.5 of the 

main section of this report. 

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

Substance Type Organism Endpoint Concentration 

(mg/l) 

Reference 

Rotifera 

(monochloroacetic 

acid) 

Rotifer (Brachionus 

calyciforus) 

EC50 48h 68.9 P. Radix et al.

(1999) 

Phytoplankton algae 

(monochloroacetic 

acid) 

Green algae 

(Scenedesmus 

subspicatus) 

EC50 48h 0.028 R. Kuhn et al.

(1990) 

Others Amphibian 

(dichloroacetic acid) 

African clawed frog 

(Xenopus laevis) 

EC50 96h 3,560 D.J. Fort et al.

(1993) 

Fish 

(trichloroacetic acid) 

Fathead minnow 

(Pimephales 

promelas) 

LC50 96h 2,000 W.H. Dennis 

Jr. et al. (1979) 

Others Amphibian 

(trichloroacetic acid) 

African clawed flog 

(Xenopus laevis) 

EC50 96h 1,740 D.J. Fort et al.

(1993) 

Phytoplankton algae 

(trichloroacetic acid) 

Green algae 

(Chlorella 

pyrenoidosa) 

LC50 14d 0.3 T. Bednarz 

(1981) 

Crustacean 

(bromoacetic acid) 

Water flea (Daphnia 

magna) 

EC50 24h 65 R. Kuhn et al.

(1989) 

Phytoplankton 

(bromoacetic acid) 

Green algae 

(Scenedesmus 

subspicatus) 

EC50 72h 0.2 as above 

(1990) 

Haloacetic 

acids 

Fish 

(dibromoacetic acid) 

Fathead minnow

(Pimephales 

promelas) 

LC50 96h 69 M.A. Mayes

et al. (1985)

ECOTOX 
GESAMP-BWWG 6/9 

ANNEX 5 

Page 35 

I:\MEPC\58\2-7.doc 

Substance Type Organism Endpoint Concentration 

(mg/l) 

Reference 

Haloacetonitriles Fish 

(dibromoacetonitrile) 

Fathead minnow 

(Pimephales 

promelas) 

LC50 96h 0.55 M.A. Mayes 

et al. (1985) 

2.2 Chronic Aquatic Toxicity Data 

Substance Type/Organism Endpoint Concentration 

(mg/l) 

Reference 

Chloroacetic acid Crustacean Water flea 

(Daphnia magna) 

NOEC 21d 32 R. Kuhn et al. (1989) 

Bromoacetic acid Crustacean Water flea 

(Daphnia magna) 

NOEC 21d 3.2 as above 

2.3 Information on Endocrine Disruption

2.3.1 The Group noted that the applicant had been unable to find any information on the 

endocrine disruption potential of haloacetic acids or haloacetonitriles. 

2.4 Sediment Toxicity

2.4.1 The Group noted that the evaluation of the effects on benthic organisms was unnecessary 

for haloacetic acids and haloacetonitriles as the absorption coefficient of all chemicals in this 

group are <500 l/kg. 

2.4.2 However, the Group indicated that it would have preferred to see specific values 

identified rather than be described as “<500 l/kg”. 

2.5 Bioavailability/Biomagnification/bioconcentration

2.5.1 The Group noted the following log Pow and calculated BCF values for the haloacetic 

acids and haloacetonitriles and recognized that, as they were all <3, the bioaccumulation 

potential of these compounds is expected to be low. 

Chemical substance logPow BCF (l/kg) Reference 

Relevant Chemicals 

Chloroacetic acid 0.34 2.1×10-1 Syracuse Research Corporation, 

Dichloroacetic acid 0.52 3.0×10-1 Syracuse Research Corporation, 

Trichloroacetic acid 1.44 1.5 Syracuse Research Corporation, 

Bromochloroacetic acid 0.61 3.5×10-1 Syracuse Research Corporation, 

Bromoacetic acid 0.43 2.5×10-1 Syracuse Research Corporation, 

Dibromoacetic acid 0.70 4.1×10-1 Syracuse Research Corporation, 

Chloroacetonitrile 0.11 1.4×10-1 Syracuse Research Corporation, 

Dichloroacetonitrile 0.29 2.0×10-1 Syracuse Research Corporation, 

Trichloroacetonitrile 1.21 1.0 Syracuse Research Corporation, 

Bromoacetonitrile 0.20 1.7×10-1 Syracuse Research Corporation, 

Dibromoacetonitrile 0.47 2.7×10-1 Syracuse Research Corporation, 

Monochloramine -1.19 1.4×10-2 Syracuse Research Corporation, 
GESAMP-BWWG 6/9 

ANNEX 5 

Page 36 

I:\MEPC\58\2-7.doc 

3 MAMMALIAN TOXICITY 

3.1 The Group noted that no mammalian toxicity data had been provided for the group of 

haloacetic acids haloacetonitrils and haloamines. 

3.2 However, the Group recalled that it had been considered necessary to review the 

toxicology of some HAA generated by other systems and considered that such a review was 

necessary for this system (section 4 of the Report). 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic) 

 Sea 

water or 

Fresh 

Water 

Test 

Duration 

Results Break-down 

products 

Reference/Comments/ 

Justification for 

missing data 

1/2-Life Seawater NR >60days MEPC 57/2/8, annex, 

para. 4.3 

4.2 Partition Coefficients

Chemical substance logPow BCF (l/kg) Reference 

Relevant Chemicals 

Chloroacetic acid 0.34 2.1×10-1 Syracuse Research Corporation, 

Dichloroacetic acid 0.52 3.0×10-1 Syracuse Research Corporation, 

Trichloroacetic acid 1.44 1.5 Syracuse Research Corporation, 

Bromochloroacetic acid 0.61 3.5×10-1 Syracuse Research Corporation, 

Bromoacetic acid 0.43 2.5×10-1 Syracuse Research Corporation, 

Dibromoacetic acid 0.70 4.1×10-1 Syracuse Research Corporation, 

Chloroacetonitrile 0.11 1.4×10-1 Syracuse Research Corporation, 

Dichloroacetonitrile 0.29 2.0×10-1 Syracuse Research Corporation, 

Trichloroacetonitrile 1.21 1.0 Syracuse Research Corporation, 

Bromoacetonitrile 0.20 1.7×10-1 Syracuse Research Corporation, 

Dibromoacetonitrile 0.47 2.7×10-1 Syracuse Research Corporation, 

Monochloramine -1.19 1.4×10-2 Syracuse Research Corporation, 

4.3 Persistence and Identification of Main Metabolites

4.3.1 No information provided. 

4.4 Reaction with Organic Matter

4.4.1 No information provided.
GESAMP-BWWG 6/9 

ANNEX 5 

Page 37 

I:\MEPC\58\2-7.doc 

4.5 Potential Physical Effects on Wildlife and Benthic Habitats 

4.5.1 No information provided. 

4.6 Potential Residues in Seafood

4.6.1 No information provided. 

5 PHYSICAL PROPERTIES

5.1 No physical property data were provided for this group of chemicals. 

6 OTHER INFORMATION

6.1 Analytical Methods for measuring the Concentration at Environmentally Relevant 

Concentrations 

6.1.1 No information provided. 

6.2 Material Safety Data Sheets provided No 

6.3 GHS Classification Not provided

6.4 Risk Characterization

Substance for PBT criteria Persistence (P) 

(Yes or No)

Bioaccumulation (B) 

(Yes or No)

Toxicity (T) 

(Yes or No)

Haloacetic acids Yes No No 

Haloacetonitoriles Yes No No 

* * * 
GESAMP-BWWG 6/9 

ANNEX 5 

Page 38 

I:\MEPC\58\2-7.doc 

Appendix 5.3 

Chemical and biological properties of Sodium bromate 

1 CHEMICAL IDENTIFICATION

1.1 The chemical formula and identification numbers are shown in paragraph 3.2.5 of the 

main section of this report. 

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

2.2 Chronic Aquatic Toxicity Data

2.2.1 The Group noted that no chronic aquatic toxicity data had been supplied for sodium 

bromate. 

2.3 Information on Endocrine Disruption

2.3.1 The Group noted that the applicant had been unable to find any information on the 

endocrine disruption potential of sodium bromate. 

2.4 Sediment Toxicity

2.4.1 The Group noted that the evaluation of the effects on benthic organisms was unnecessary 

for sodium bromate as its absorption coefficient is <500 l/kg. 

2.5 Bioavailability/Biomagnification/bioconcentration

2.5.1 The Group noted that no data had been provided for sodium bromate but as an inherent 

component of seawater agreed that it was unnecessary to provide it. 

3 MAMMALIAN TOXICITY 

3.1 The Group noted that no mammalian toxicity data had been provided for sodium bromate. 

3.2 However, the Group recalled that bromate ions are deemed to be genotoxic/carcinogenic 

and information should be provided in the application for Final Approval. 

Type Organism Endpoint Concentration 

(mg/L) 

Reference 

Mollusk Pacific oyster 

(Crassostrea gigas) 

EC50 96h > 30 E.A. Crecelius 

(1979) 

Nematodes & 

Flatworms 

Planarian 

(Polycelis nigra)

LT50 48h 3,018 J.R. Erichsen 

Jones (1941) 
GESAMP-BWWG 6/9 

ANNEX 5 

Page 39 

I:\MEPC\58\2-7.doc 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

 ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic) 

 Sea water 

or Fresh 

Water 

Test 

Duration 

Results Break-down 

products 

Reference/Comments/ 

Justification for 

missing data 

1/2-Life Seawater NR >60days MEPC 57/2/8, 

annex, para. 4.3 

4.2 Partition Coefficients

Chemical substance log Pow BCF (l/kg) Reference 

Relevant Chemicals 

Sodium bromate -7.18 3.7×10-7 Syracuse Research Corporation, 

4.3 Persistence and Identification of Main Metabolites

4.3.1 No information provided. 

4.4 Reaction with Organic Matter

4.4.1 No information provided.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats 

4.5.1 No information provided. 

4.6 Potential Residues in Seafood

4.6.1 No information provided. 

5 PHYSICAL PROPERTIES

5.1 No physical property data were provided for this group of chemicals. 

6 OTHER INFORMATION

6.1 Analytical Methods for measuring the Concentration at Environmentally Relevant 

Concentrations 

6.1.1 No information provided. 

6.2 Material Safety Data Sheets provided No 

6.3 GHS Classification Not provided

6.4 Risk Characterization

Substance for PBT criteria Persistence (P) 

(Yes or No)

Bioaccumulation (B) 

(Yes or No)

Toxicity (T) 

(Yes or No)

Sodium bromate Yes No No 

* * * 
GESAMP-BWWG 6/9 

ANNEX 5 

Page 40 

I:\MEPC\58\2-7.doc 

Appendix 5.4 

Chemical and biological properties of Sodium sulphite 

1 CHEMICAL IDENTIFICATION

1.1 The chemical formula and identification numbers are shown in paragraph 3.2.5. 

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

Type Organism Endpoint Concentration

(mg/l) 

Reference 

Fish Leuciscus idus NOEC 96h

LC50 96h 

220 

220-460 

IUCLID 

Crustacean Daphnia magna TLm 100h 203 as above 

Mollusk Buccinum undatum LC50 24h 400 as above 

Echinoderm Psammechinus miliaris LC50 24h 330(as SO3) as above 

Phytoplankton Green algae 

(Chlamydomonas reinhardtii) 

(Chlorella vulgaris) 

(Scenedesmus basiliensis) 

EC50 8.9h

EC50 6.4h

EC50 8.2h

16-32 (as SO3) 

as above 

as above 

as above 

A. STAMM (1980) 

2.2 Chronic Aquatic Toxicity Data

2.2.1 The Group noted that no chronic toxicity data had been provided for sodium sulphite. 

2.3 Information on Endocrine Disruption

2.3.1 The Group noted that the applicant had been unable to find any information on the 

endocrine disruption potential of sodium sulphite. 

2.4 Sediment Toxicity

2.4.1 The Group noted that the evaluation of the effects on benthic organisms was unnecessary 

for sodium sulphite as its absorption coefficient is<500 l/kg. 

2.5 Bioavailability/Biomagnification/bioconcentration

2.5.1 The Group noted the following log Pow and calculated BCF values sodium sulphite and 

recognized that, as it is <3, the bioaccumulation potential of it is expected to be low. 

Chemical substance log Pow BCF (l/kg) Reference 

Active substance 

Sodium Sulphite -7.78 1.3×10-7 Syracuse Research Corporation, 
GESAMP-BWWG 6/9 

ANNEX 5 

Page 41 

I:\MEPC\58\2-7.doc 

3 MAMMALIAN TOXICITY 

3.1 Oral Toxicity 

Substance Species (animal) LD50 Reference 

Sodium sulphite Rat 2.61 g/kg bw IUCLID, Na2SO3,(2000) 

3.1.1 According to the presented data, sodium sulphite is not considered to be an acute toxicant 

by oral route. 

3.2 Dermal Toxicity

3.2.1 No data provided. 

3.3 Inhalation Toxicity

3.3.1 No data provided. 

3.4 Corrosion/Irritation

3.4.1 Skin irritation data 

Substance Species 

(animal) 

Exposure 

duration 

Concentration Observation and 

remark 

Reference 

Sodium 

sulphite 

Rabbit Not 

reported 

Not reported Not irritating 

Draize 

IUCLID, 

Na2SO3,(2000) 

3.4.1.1 According to the presented data, sodium sulphite is not considered to be a skin irritant. 

3.4.2 Eye Irritation data 

Substance Species 

(animal) 

Exposure 

duration & 

concentration 

Method Observation and 

remark 

Reference 

Sodium 

sulphite 

Rabbit Not reported BASF-test Not irritating IUCLID, 

Na2SO3,(2000) 

3.4.2.1 According to the presented data, sodium sulphite is not considered to be an eye irritant. 

3.5 Sensitization

3.5.1 No data provided. 

3.6 Repeated Dose Toxicity

Substance Species 

(animal)

Dosage route & 

concentration 

Duration of 

treatment 

Observation and 

remark 

Reference 

Sodium 

sulphite 

No data. 

WHO has recognized as non toxic. 

WHO Food 

Additives 

Series21 IPCS 

INCHEM Home
GESAMP-BWWG 6/9 

ANNEX 5 

Page 42 

I:\MEPC\58\2-7.doc 

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

towards repeated exposure to sodium sulphite. 

3.7 Developmental toxicity data 

Substance Species 

(animal) 

Dosage route & 

concentration 

Duration of 

treatment 

Observation 

and remark 

Reference 

Sodium 

sulphite 

Rat 

Wistar 

Oral Feed 

0.32; 0.63; 1.25; 

2.5 and,5% 

(300, 1100, 2100 

and 3300 mg/kg) 

8-20 days of 

gestation, daily 

20 days and 

after birth. 

No significant 

effect 

IUCLID Na2SO3

(55)(56)(57) 

3.7.1 From the submitted data there seems to be no relevant toxicological concerns towards 

developmental toxicity. 

3.8 Reproductive Toxicity Data

Substance Species 

(animal) 

Dosage route & 

concentration 

Duration of 

treatment 

Observation 

and remark 

Reference 

Sodium 

sulphite 

No data 

With WHO’s recognition testing for reproductive toxicity is deemed 

unnecessary. 

WHO Food 

Additives 

Series 21 IPCS 

INCHEM Home 

3.9 Carcinogenicity

Substance Species 

(animal) 

Type of test, 

duration 

Doses 

(mg/L, FAC) 

Observation and 

remark 

Reference 

Sodium 

sulphite 

No specific data 

IARC designates as “group 3”. 

Pan 

Pesticides 

Database 

3.9.1 Sodium sulphite is classified as IARC group 3 (Not classifiable as to its carcinogenicity) 

since no data were available on the carcinogenicity in experimental animals of sulphites. 

Evaluation by IARC states that there is inadequate evidence for the carcinogenicity in 

experimental animals of sulphites. 

3.10 Mutagenicity

Substance Species Type of test Concentration 

(mg/l) 

Observation 

and remark 

Reference 

Sodium 

sulphite 

In vitro: 

Salmonella 

typhimurium 

OECD 

Guide-line 

471 “Genetic 

Toxicology: 

Salmonella 

typhimurium 

Reverse 

Mutation 

Assay” 

20-500 μg/ plate 

Metabolic activation: 

with and without 

Negative IUCLID 

Na2SO3(2000) 
GESAMP-BWWG 6/9 

ANNEX 5 

Page 43 

I:\MEPC\58\2-7.doc 

3.10.1 From the submitted data on Ames test there seems to be no relevant toxicological 

concerns towards mutagenicity. 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic) 

 Sea 

water or 

Fresh 

Water 

Test 

Duration 

Results Break-down 

products 

Reference/Comments/ 

Justification for 

missing data 

1/2-Life Seawater NR >60days MEPC 57/2/8, annex, 

para. 4.3 

4.2 Partition Coefficients

Chemical substance log Pow BCF (l/kg) Reference 

Relevant Chemicals 

Sodium bromate -7.18 3.7×10-7 Syracuse Research Corporation, 

4.3 Persistence and Identification of Main Metabolites

4.3.1 No information provided. 

4.4 Reaction with Organic Matter

4.4.1 No information provided.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats 

4.5.1 No information provided. 

4.6 Potential Residues in Seafood

4.6.1 No information provided. 

5 PHYSICAL PROPERTIES

5.1 No physical property data were provided for this group of chemicals. 

6 OTHER INFORMATION

6.1 Analytical Methods for measuring the Concentration at Environmentally Relevant 

Concentrations 

6.1.1 No information provided. 

6.2 Material Safety Data Sheets provided No 
GESAMP-BWWG 6/9 

ANNEX 5 

Page 44 

I:\MEPC\58\2-7.doc 

6.3 GHS Classification Not provided

6.4 Risk Characterization

Substance for PBT criteria Persistence (P) 

(Yes or No)

Bioaccumulation (B) 

(Yes or No)

Toxicity (T) 

(Yes or No)

Sodium sulphite No No No 

* * * 
GESAMP-BWWG 6/9 

ANNEX 5 

Page 45 

I:\MEPC\58\2-7.doc 

Appendix 5.5 

Chemical and biological properties of Sodium hypochlorite 

1 CHEMICAL IDENTIFICATION

1.1 The chemical formula and identification numbers for sodium hypochlorite are shown in 

paragraph 3.2.5 of the main section of this report. 

2 EFFECTS ON AQUATIC ORGANISMS

2.1 The Group noted that no data had been provided for the effects of sodium hypochlorite on 

aquatic organisms. 

2.2 However, the Group recognized that as this Active Substance employed as part of 

the BWMS is degraded by the use of sodium sulphite before being released into the sea, such 

information was unnecessary. 

3 MAMMALIAN TOXICITY

Regarding the toxicological evaluation of sodium hypochlorite please see section 4 of the Report. 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic) 

4.1.1 The Group noted that such information was not necessary as the product is denatured with 

sodium sulphite prior to the ballast water being released into the sea. 

4.2 Partition Coefficients

4.2.1 The Group noted that such information was not necessary as the product is denatured with 

sodium sulphite prior to the ballast water being released into the sea. 

4.3 Persistence and Identification of Main Metabolites

4.3.1 No information provided but none necessary. 

4.4 Reaction with Organic Matter

4.4.1 No information provided but none necessary.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats 

4.5.1 No information provided but none necessary. 
GESAMP-BWWG 6/9 

ANNEX 5 

Page 46 

I:\MEPC\58\2-7.doc 

4.6 Potential Residues in Seafood

4.6.1 No information provided but none necessary. 

5 PHYSICAL PROPERTIES

5.1 The Group noted the physical properties of sodium hypochlorite, as provided by the 

applicant, and shown in the table below: 

Chemical name Sodium hypochlorite 

Molar mass 74.44 g/mol 

Formula NaClO 

Melting point -20 to -30oC 

Boiling point 96 to 120oC at 1013 hPa 

Specific gravity 1.15 (13.1wt% as FAC) aqueous solution at 25oC 

Vapor Pressure 17.4 – 20 kPa at 20oC 

Aqueous solubility 29.3 g/100g at 0oC 

PH >11.5 

Octanol-water partition coefficient log Pow=-3.42 

6 OTHER INFORMATION

6.1 Analytical Methods for measuring the Concentration at Environmentally Relevant 

Concentrations 

6.1.1 No information provided. 

6.2 Material Safety Data Sheets provided No 

6.3 GHS Classification Not provided

6.4 Risk Characterization

Substance for PBT criteria Persistence (P) 

(Yes or No)

Bioaccumulation (B) 

(Yes or No)

Toxicity (T) 

(Yes or No)

 

* * * 
GESAMP-BWWG 6/9 

ANNEX 5 

Page 47 

I:\MEPC\58\2-7.doc 

Appendix 5.6 

Chemical and biological properties of sodium sulphate 

1 CHEMICAL IDENTIFICATION 

1.1 The chemical formula and identification numbers for sodium sulphate are shown in 

paragraph 3.2.5 of the main section of this report. 

2 EFFECTS ON AQUATIC ORGANISMS

2.1 The Group noted that the applicant had not provided any data on the effects of sodium 

hypochlorite on aquatic organisms. 

2.2 However, the Group agreed that, as this would be discharged to sea at 1% of the 

concentration of natural seawater, such data would not be required. 

3 MAMMALIAN TOXICITY

3.1 Oral Toxicity 

Substance Species (animal) LD50 Reference 

Sodium sulfate Mouse 5.99 g/kg bw OECD SIDS, 

Okahara, (2005) 

3.3.1 According to the presented data, sodium sulfate is not considered to be an acute toxicant 

by oral route. 

3.2 Dermal Toxicity

2.2.1 No data provided. 

3.3 Inhalation Toxicity

2.2.2 No data provided. 

3.4 Skin irritation data 

Substance Species 

(animal) 

Exposure 

duration 

Concentration Observation and 

remark 

Reference 

Sodium 

sulfate 

Rabbit 4 hours 

Occlusive 

500 mg Slightly irritating 

EC classification-not 

irritating OECD 404, 

Draize 

OECD SIDS, 

Na2SO4,(2005) 

3.4.1 According to the presented data, sodium sulphite is not considered to be a skin irritant. 
GESAMP-BWWG 6/9 

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3.5 Eye Irritation data 

Substance Species 

(animal) 

Exposure 

duration & 

concentration 

Method Observation and 

remark 

Reference 

Sodium 

sulfate 

Rabbit 90 mg, 

pulverized 

into 

conjunctival 

sac 

OECD 

guideline 

405 

Slight irritating 

redness of the 

conjunctiva 

observed. The 

redness was 

reversible within 7 

days. 

OECD SIDS, 

Na2SO4,(2005) 

3.5.1 According to the presented data, sodium sulfate is not considered to be an eye irritant. 

3.6 Sensitization

3.6.1 No data provided 

3.7 Repeated Dose Toxicity

Substance Species 

(animal)

Dosage route & 

concentration 

Duration of 

treatment 

Observation and 

remark 

Reference 

Sodium 

sulfate 

Rats 

Sprague 

Dawley 

In food 0.84% in 

diet 

27 and 44 

weeks daily 

NOAEL 320-400 

mg/kg/day 

Mortality, tumor, 

Body weight, food 

and water 

consumption 

OECD SIDS, 

Na2SO4,(2005) 

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

towards repeated exposure to sodium sulfate. 

3.8 Developmental toxicity data 

Substance Species 

(animal) 

Dosage route & 

concentration 

Duration of 

treatment 

Observation 

and remark 

Reference 

Sodium 

sulfate 

The limited available data give no indication that sodium sulfate is 

toxic for development. 

OECD SIDS 

(2005) 

3.8.1 From the submitted data there seems to be no relevant toxicological concerns towards 

developmental toxicity. 
GESAMP-BWWG 6/9 

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3.9 Reproductive Toxicity Data

Substance Species 

(animal) 

Dosage route & 

concentration 

Duration of 

treatment 

Observation 

and remark 

Reference 

Sodium 

sulfate 

The available data on fertility are quite limited but in view of the fact 

that the substance is abundantly occurring in the body, toxicity for 

reproduction is unlikely. 

OECD SIDS 

(2005) 

3.9.1 From the submitted data there seems to be no relevant toxicological concerns towards 

reproductive toxicity. 

3.10 Carcinogenicity

Substance Species 

(animal) 

Type of test, 

duration 

Doses (mg/l, 

FAC) 

Observation and 

remark 

Reference 

Sodium 

sulfate 

Swiss 

albino 

mice 

Carcinogenicity 

26 weeks, daily 

31 μg in 0.01 

ml (0.9%) per g 

body weight, 

s.c. injected 

Tumor of subcutis 

and/or skin in 1% 

of the female and 

4% in male 

(normal for this 

strain in this lab). 

OECD SIDS 

(2005) 

3.10.1 From the submitted data there seems to be no relevant toxicological concerns towards 

carcinogenicity. 

3.11 Mutagenicity

Substance Species Type of test Concentration 

(mg/l) 

Observation 

and remark 

Reference 

Sodium 

sulfate 

In vitro: 

Salmonella 

typhimurium 

Ames test 

under GLP 

Salmonella 

Microsome 

test 

 312-5,000μg 

Metabolic S-9 

activation: with and 

without 

Negative OECD SIDS 

(2005) 

3.11.1 From the submitted data on Ames test there seems to be no relevant toxicological 

concerns towards mutagenicity. 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic) 

4.1.1 The Group noted that such information was not necessary as the product is denatured with 

sodium sulphite prior to the ballast water being released into the sea. 

4.2 Partition Coefficients

4.2.1 The Group noted that such information was not necessary as the product is denatured with 

sodium sulphite prior to the ballast water being released into the sea. 
GESAMP-BWWG 6/9 

ANNEX 5 

Page 50 

I:\MEPC\58\2-7.doc 

4.3 Persistence and Identification of Main Metabolites

4.3.1 No information provided but none necessary. 

4.4 Reaction with Organic Matter

4.4.1 No information provided but none necessary.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats 

4.5.1 No information provided but none necessary. 

4.6 Potential Residues in Seafood

4.6.1 No information provided but none necessary. 

5 PHYSICAL PROPERTIES

Chemical name Sodium sulfate 

Molar mass 142.05 g/mol 

Formula Na2SO4

Melting point 888oC 

Boiling point 1429 oC 

Specific gravity 1.10 g/cm3 (10wt%) at 27oC 

Vapor Pressure Substantially 0 mm Hg at ambient temperature

Aqueous solubility 19.5 g/100g at 0oC 

PH Neutral 

Octanol-water partition coefficient logPow=-4.4 

6 OTHER INFORMATION 

6.1 Analytical Methods for measuring the Concentration at Environmentally Relevant 

Concentrations

6.1.1 No information provided. 

6.2 Material Safety Data Sheet No 

6.3 GHS Classification No 

6.4 Risk Characterization 

*** 
GESAMP-BWWG 6/9 

I:\MEPC\58\2-7.DOC 

ANNEX 6 

REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER MANAGEMENT 

SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES 

A Combined Ballast Water Management System consisting of Sediment Removal and an 

Electrolytic Process using Seawater to produce Active Substances 

Submitted for Basic Approval by the Netherlands 

0 SUMMARY

0.1 The Group noted that the Combined Ballast Water Management System uses a 

combination of filtration and electrolysis to treat the ballast water. 

0.2 The Group was satisfied that, as the system does not involve the storage or generation of 

chemicals to treat ballast water, there were no associated storage safety problems. 

0.3 However, it was recognized that the system produces various Relevant Chemicals with 

safety and environmental concerns. 

0.4 The Group reviewed the hazards and risks associated with each of the Relevant 

Chemicals, as shown in appendices 1-3. 

0.5 The Group concluded that chlorinated and brominated disinfection by-products are the 

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

genotoxicity/carcinogenicity; therefore they will have to be kept below toxicological critical 

levels (bromoform <100 μg/L, WHO Guidelines for Drinking Water Quality, 2003). The Group 

noted that the applicant didn’t provide information concerning the Human Exposure Scenario 

(MEPC 56/2/2, annex 9) and therefore the risk characterization for human health could not be 

adequately performed. 

0.6 Having reviewed all the information in the non-confidential submission and all 

information received from the Applicant during the GESAMP-BWWG meeting the Group 

decided to propose to MEPC to grant Basic Approval to the BWMS submitted by the 

Netherlands with the following considerations if the system has to be reviewed for 

Final Approval in the future:

.1 All the topics addressed under Chapter 2 (Completeness of the Dossier as 

mentioned below) have to be addressed by the Applicant carefully.

.2 The Group noted that the applicant did not provide information concerning the 

Human Exposure Scenario (MEPC 56/2/2, annex 9) and therefore the risk 

characterization for human health could not be adequately performed. 

.3 The Group considered that the organic content of the test water with treated 

natural seawater should be provided for Final Approval. 

.4 The Group considered that the Level of Quantification (LOQ) for the haloacetic 

acids were too high. This may lead to understatement of the potential levels in the 

treated ballast water. This uncertainty should be clarified in additional analyses 

during the full scale testing on land and/or onboard ships by the applicant. 
GESAMP-BWWG 6/9 

ANNEX 6 

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I:\MEPC\58\2-7.doc 

1 INTRODUCTION

1.1 The data used to evaluate this system were extracted from that supplied by 

the Netherlands in document MEPC 57/2/7, which was supplemented by additional confidential 

information provided by the applicant after a request for further information by the Group during 

its meeting. The Group recognized by that the submission by the Netherlands did not contain 

any confidential information. 

2 COMPLETENESS OF DOSSIER

2.1 The Group had the following concerns which it considered should be addressed prior to 

application for Final Approval. Having put such concerns to the applicant, the Group’s reaction 

to the responses received are also shown below: 

 .1 a more detailed description of the system needs to be provided to include 

inter alia: 

 .1 system layout – the Group agreed that the additional information provided 

was acceptable for Basic Approval; 

 .2 details of the protection devices and failsafe controls incorporated – the 

Group agreed that the additional information provided was acceptable for 

Basic Approval; 

 .3 specific details of the treatment (e.g., is treatment upon intake and/or 

treatment upon discharge) – the Group agreed that the additional 

information provided was acceptable; 

 .4 maximum dose concentration – the Group noted that this was stated as 

2mg/L but not consistently reported throughout the documentation; 

 .5 maximum allowable discharge concentration – Having received the 

response from the applicant, the Group still wanted to know the maximum 

discharge concentration that the system would produce NOT what is 

allowable; and 

 .6 means of determining and controlling dosage rates (including differing 

salinity of uptake water) – Having received the response from the 

applicant, the Group was satisfied that the additional information provided 

was acceptable for Basic Approval noting that it was not sufficient for 

Final Approval; 

 .2 it was noted that the tests referred to in the submission had been carried out with a 

single dose of 10 mg/L sodium hypochlorite and this resulted in table 2.4 where 

different disinfection by-products had been determined. It was not clear what 

would happen if the system had been applied at both ballasting and deballasting – 

the response satisfied the Group but it still wanted to know the concentration of 

by-products at the point of discharge; 
GESAMP-BWWG 6/9 

ANNEX 6 

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I:\MEPC\58\2-7.doc 

 .3 the quantification of THMs and HAAs for salted fresh water maybe completely 

different from those obtained from natural seawater or brackish water – the 

applicant indicated that tests had been carried out in natural seawater; 

 .4 the Group needed clarification of whether the doses are for both ballast intake and 

discharge and how it is ensured that the maximum concentration of FAC is 

environmentally acceptable at the time of discharge – the Group was not entirely 

satisfied with the response and agreed that a complete description of monitoring 

and control systems would be needed for Final Approval; 

 .5 the Group noted that the application, indicated that the generation of free 

hydrogen gas does not pose risk to the ship or crew but requested further 

verification of this statement – Based on the response, the Group recognized that 

the theoretical calculations indicated little risk, however, as hydrogen will be 

entrained in solution and the treated ballast water in the tank will have little free 

volume then this risk will require further evaluation during full scale testing to 

verify the calculated no risk indicated; 

 .6 results of the corrosion monitoring need to be presented – the Group agreed that 

the information provided was acceptable for Basic Approval but more information 

would be required for Final Approval; 

 .7 the risks associated with the additional known by-products may need to be 

quantified e.g., dibromochloromethane and bromochloroacetic acid. The 

additional data provided to the Group were acceptable for Basic Approval; 

 .8 references 1 and 10-18 had not been included on the CD - these were subsequently 

sent; and 

 .9 the Group requested the input parameters used to run the MAMPEC model for all 

substances – these data were provided and the Group noted that the calculated 

PEC had been made using a degradation rate for FAC but if this was not applied 

the resultant PEC produces a PEC/PNEC ratio of 70 and 110. Whilst recognizing 

that the PEC is a long term steady state value, some concern was still expressed 

that the short term exposure had not been taken properly into account. It was also 

agreed that this treatment system required further development and refinement as 

system discharging this level of FAC would probably not be recommended, by the 

Group, for Final Approval. 

3 DESCRIPTION OF THE SYSTEM

3.1 Overview 

3.1.1 The Group noted that this Ballast Water Management System (BWMS) consists of two 

modular components: 

.1 the Sedimentor, a multi-hydrocyclone unit, which is reported as being capable of 

removing particles >20 μm with an efficiency of 100% and particles of >10 μm 

with an efficiency of > 80%; and 
GESAMP-BWWG 6/9 

ANNEX 6 

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I:\MEPC\58\2-7.doc 

.2 the Termanox, which electrolyses the ballast water producing Active Substances 

including Free Active Chlorine (FAC) for the deactivation of biota, at both 

ballasting and de-ballasting. 

3.1.2 In addition it was noted that both the Sedimentor and the Termanox comprise modular 

components to handle ballast water flows ranging from 50 m3/h to >5,000 m3/h. 

3.1.3 The applicant indicated that the type of electrolytic cell employed in this system has a 

long-lasting coating that requires maintenance (cleaning) once a year for approximately three to 

five years. 

3.1.4 The Group noted that no chemicals are stored onboard as the FAC is generated in situ. 

3.2 Chemical reactions involved in the electrolysis of seawater (provided by the applicant) 

An idealized drawing of a cell in which an aqueous solution of sodium chloride is electrolysed

NaCl (s) + H2O (l) Æ Na+ (aq)+ Cl- (aq) 

3.2.1 The Na+ ions migrate toward the negative electrode and the Cl- ions migrate toward the 

positive electrode. There are two substances that can be reduced at the cathode: Na+ ions and 

water molecules. 

Cathode (-): 

 Na+

 + e- Na Eo

red = -2.71 V 

 2 H2O + 2 e- H2 + 2 OH- Eo

red = -0.83 V 

3.2.2 Because it is much easier to reduce water than Na+ ions, the only product formed at the 

cathode is hydrogen gas. 

3.2.3 There are also two substances that can be oxidized at the anode: Cl- ions and water 

molecules. 

Anode (+): 

 2 Cl- Cl2 + 2 e- Eo

ox = -1.36 V 

 2 H2O O2 + 4 H+ + 4 e- Eo

ox = -1.23 V 
GESAMP-BWWG 6/9 

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3.2.4 The standard-state potentials for these half-reactions are so close to each other that we 

might expect to see a mixture of Cl2 and O2 gas collect at the anode. In practice, the only product 

of this reaction is Cl2. 

3.2.5 In summary, electrolysis of aqueous NaCl solutions gives a mixture of hydrogen and 

chlorine gas and an aqueous sodium hydroxide solution. 

 

2 NaCl(aq) + 2 H2O(l) 2 Na+

(aq) + 2 OH-(aq) + H2(g) + Cl2(g) 

3.2.6 The products of the electrolysis of aqueous sodium chloride react with water to form 

sodium hypo-chlorite. 

 Cl2(g) + H2O(l) HOCl(aq) + H+ (aq)+ Cl- (aq) 

 HOCl (aq) H+ (aq) + ClO- (aq) 

3.2.7 The Group noted that the applicant did not include or consider the bromide analogues of 

these reactions in natural seawater. 

3.3 Active Substances (AS), Relevant Chemicals (RC) and Other Chemicals (OC)

3.3.1 It was recognized that the generation of Free Active Chlorine (FAC), by electrolysis, 

leads to the formation of other halogenated by-products in seawater due to the reaction with 

organic compounds and other components in seawater such as ammonia. 

3.3.2 The applicant identified Free Active Chlorine (FAC) and Total Residual Chlorine 

as Active Substances and measured their concentrations in seawater taken from the harbour 

of Harlingen (the Netherlands) and treated with the system at a rate of 100 m3

/h. It was noted 

that neither the initial dose leading to the concentration of TRC and FAC shown below nor the 

organic content of the test water, was indicated. The results are shown below: 

Active Substance Sampling time (minutes after treatment) 

Control 

(Untreated water) 0 30 120 

TRC mg/L <0.01 2.38 1.83 1.15 

FAC mg/L <0.01 1.67 1.25 0.51 

3.3.3 The Group noted that the applicant had identified the following potential Relevant 

Chemicals which might be formed as a result of the treatment process and which had been the 

quantifiably analysed in the treated ballast water. The results of the analyses provide are shown 

in the table below: 
GESAMP-BWWG 6/9 

ANNEX 6 

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Concentrations (μg/L) of potential Relevant Chemicals in treated natural seawater samples

Compound Time of Sampling After Treatment 

Units Control 0 min 30 min 12 h 24 h 

Halomethanes 

dichloromethane μg/L <1.0 <1.0 <1.0 <1.0 <1.0 

1,1-dichloroethane μg/L <0.5 <0.5 <0.5 <0.5 <0.5 

1,2-dichloroethane μg/L <0.5 <0.5 <0.5 <0.5 <0.5 

trans-1,2-dichloroethene μg/L <0.5 <0.5 <0.5 <0.5 <0.5 

cis-1,2-dichloroethene μg/L <0.5 <0.5 <0.5 <0.5 <0.5 

1,2-dichloropropane μg/L <0.5 <0.5 <0.5 <0.5 <0.5 

trichloromethane μg/L <0.1 <0.1 <0.1 <0.1 <0.1 

tetrachloromethane μg/L <0.1 <0.1 <0.1 <0.1 <0.1 

1,1,1-trichloroethane μg/L <0.1 <0.1 <0.1 <0.1 <0.1 

1,1,2-trichloroethane μg/L <0.1 <0.1 <0.1 <0.1 <0.1 

trichloroethene μg/L <0.1 <0.1 <0.1 <0.1 <0.1 

tetrachloroethene μg/L <0.1 <0.1 <0.1 <0.1 <0.1 

sum C/T dichloroethene μg/L <0.5 <0.5 <0.5 <0.5 <0.5 

sum chloroaliphatics μg/L <2.1 <2.1 <2.1 <2.1 <2.1 

dibromomethane μg/L <0.5 <0.5 <0.5 <0.5 <1.2 

tribromomethane μg/L <0.5 200 200 280 290 

bromodichloromethane μg/L <0.5 1.3 <0.5 <0.5 <0.5 

dibromochloromethane μg/L <0.5 9.5 9.1 12 13 

 

Haloacetic acids 

Chloroacetic Acid μg/L <1 <1 <1 <1 <1 

Dichloroacetic acid μg/L <1 <1 <1 <1 <1 

Trichloroacetic acid μg/L <1 <1 <1 <1 <1 

Bromoacetic acid μg/L <1 <1 <1 <1 <1 

Dibromoacetic acid μg/L <1 62 50 64 <1 

tribromoacetic acid μg/L <1 <1 <1 <1 <1 

Bromochloroacetic acid μg/L <1 1.3 1.6 2.1 <1 

Dibromochloroacetic acid μg/L <1 <1 <1 <1 <1 

Bromodichloroacetic acid μg/L <1 <1 <1 <1 <1 

3.3.4 It was noted that the halomethanes had been analysed according to NEN/ISO 15680 and 

that the haloacetic acids had been analysed using GC-MS, all analyses being performed at 

accredited laboratories. However, it was also noted that the applicant had not reported the 

organic content of the test water which had yielded the above results. 

3.3.5 The Group also noted that, in a separate test, using fresh surface water, to which salt had 

been added, chloroamines had been analysed. Whilst it was noted that no chloroamines had been 

detected in this test, concern was expressed that the fresh water might not contain sufficient 

organic compounds, to produce measurable quantities of chloroamines as a result of the treatment 

process. As a result, the Group considered that the organic content of the test water should be 

provided for Final Approval. 
GESAMP-BWWG 6/9 

ANNEX 6 

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3.3.6 Based on the analytical data shown in the table above and general information about 

electrolysis, the Group concurred with the views of the applicant that: 

 .1 Free Active Chlorine should be treated as an Active Substance; 

 .2 the hydroxyl radicals formed during the electrolytic process should not be 

regarded as Relevant Chemicals due to their very short half-lives; and 

 .3 the formation of hydrogen and chlorine, during the process, should be regarded as 

a potential safety hazard which needs to be evaluated further. 

3.3.7 In addition, the Group considered that all identified by-products including 

dibromochloromethane, tribromomethane, dibromoacetic acid and bromochloroacetic acid 

should be treated as Relevant Chemicals and should be analysed for in samples from the land 

based tests. The Group considered further that the Levels of Quantification (LOQ) for the 

haloacetic acids were too high and that this may lead to an underestimation of the levels in the 

treated ballast water. This uncertainty should be clarified in additional analyses during the full 

scale testing on land and/or onboard ships by the applicant. 

3.3.8 The physicochemical and biological properties of the Active Substance and Relevant 

Chemicals are shown in appendices 1-3. 

4 HUMAN HEALTH ASSESSMENT

4.1. The Group considered that the human health risk assessment had not been satisfactorily 

provided. Therefore, the Group recommended that for Final Approval the following information 

should be submitted: 

.1 an (M)SDS of the active substances and relevant chemicals generated by the 

system (5. Methodology (G9)); 

.2 a description and full understanding of the processes and unit operations in which 

human exposure may occur; and 

.3 a human health risk assessment based on the human exposure scenario – HES 

(7.2.3. Methodology, appendix 2 (G9)). 

4.2 The Group noted that, according to the presented data (Appendix I, part 3, Mammalian 

toxicity), tribromomethane is considered to be harmful by oral exposure. Furthermore, 

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

COM (2007) 355 final). However, dibromoacetic acid, is not considered to be an acute oral 

toxicant. Furthermore the Group concluded that the acute toxicity of sodium hypochlorite is low 

by the oral, dermal and inhalation routes of exposure. 

4.3 It was also noted that hypochlorite is classified as a skin and eye irritant. 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). 
GESAMP-BWWG 6/9 

ANNEX 6 

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4.4 From the submitted data, the Group noted that some reproductive toxicological effects 

were observed associated with exposure to dibromoacetic acid and tribromomethane to rodents 

at high doses. 

4.5 Based on the overall information, the Group agreed that the relevant toxicological 

concerns related to human exposure towards hypochlorite, tribromomethane and dibromoacetic 

acid were mostly acute in nature and should be addressed by the appropriate risk mitigation 

measures put in place. 

4.6 In addition, Chlorinated and Brominated DPB have demonstrated a potential for human 

genotoxicity/carcinogenicity therefore the Group recommended that these relevant chemicals will 

have to be kept below toxicological critical levels (e.g., bromate <10 μg/L; bromoform <100 μg/L;

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

5 RISKS TO SAFETY OF THE SHIP, ITS CREW AND THE GENERAL PUBLIC

5.1 The Group recognized that as the Active Substance and Relevant Chemicals are generated 

in situ, there were not any storage hazards or risks. Whilst recognizing the irritancy potential to 

skin eyes and the respiratory system of FAC, at the concentrations, indicated by the applicant, in 

the treated ballast water or released into the environment, the Group agreed that these chemicals 

were unlikely to pose any threat to people. 

5.2 However, the Group agreed that additional safety precautions should be specified 

following further evaluation of the risks posed by the system, particularly including 

precautionary measures to be taken when entering ballast water tanks. 

5.3 The Group noted that whilst the applicant stated that the electrolytic cells and connecting 

pipes were fully protected by special coatings, no data or descriptions were provided of these 

coatings and their resistant to highly oxidative solutions. 

5.4 The Group also noted that applicant considers FAC corrosive but that its disappearance 

will be rapid and that tank coatings will be sufficient corrosion mitigation. The Group noted that 

the applicant did not provide either literature or test data which quantify the extent of corrosion 

on either relevant metallic or non-metallic materials at the treatment concentration or possible 

exposure concentration. While the need for coatings within the ballast tanks is recognized, it 

cannot be expected that ballast tanks will be maintained with a defect free coating systems as 

ship tanks can be expected to have exposed substrates of up to 15% of the coated surface. With 

respect to non-metallic materials, it is known that TRC exceeding 1 mg/L can cause degradation 

of some non-metallic materials commonly used as gaskets or sealing materials requiring the use 

of fluorinated polymer materials. 

5.5 Finally the Group recognized that the applicant did not provide either literature or test 

data which quantify the extent of corrosion on either relevant metallic or non-metallic materials. 

While the need for epoxy coatings within the ballast tanks is recognized, it cannot be expected 

that ballast tanks will be maintained with a defect free coating systems as ship tanks can be 

expected to have exposed substrates of up to 15% of the coated surface. 

5.6 With respect to non-metallic materials, it is known that TRO exceeding 1 mg/L can cause 

degradation of some non-metallic materials commonly used as gaskets or sealing materials, but 

the applicant does not address this concern. 
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5.7 The Group recommends that long-term studies, as appropriate, be carried out or otherwise 

documented from literature to quantify, at the treatment and possible exposure concentrations, 

resultant ballast tank coatings degradation and the expected uniform and localized corrosion rates 

on typical marine vessel metallic (e.g., steel, galvanized steel, zinc, stainless steel, etc.) and 

non-metallic materials (e.g., EPDM rubber) materials used for ballast tanks, fixtures and piping. 

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

TOXICITY (T) 

6.1 The Group agreed on the following PBT characteristics of the AS and RC associated with 

this system: 

Chemical Persistent (y/n) Bioaccumulative 

(y/n) 

Toxic (y/n) 

Sodium hypochlorite 

(FAC) 

No No Yes 

Tribromomethane Yes No No 

2,2-Dibromoacetic acid No No No 

6.2 Based on the results of table 6.1 the Group concluded that these chemicals should not be 

classified as PBT-substances. 

7 ENVIRONMENTAL RISK ASSESSMENT 

7.1 Calculation of the predicted environmental concentrations of the Active Substance 

and the Relevant Chemicals 

7.1.1 The Group noted that for the calculation of the Predicted Environmental Concentration 

(PEC), the model MAM-PEC, version 2.0, had been applied. This model is freely available and 

can be downloaded. The model has been developed by Delft Hydraulics (now DELTARES) and 

the Free University, Amsterdam. The model was developed to calculate leaching of anti-fouling 

paints from ships. It is based on the assumption that a permanent source of the pollutant is 

present in the harbour and casualties a steady state concentration f the pollutant. Calculations can 

be done for different harbours with different dimensions and “surroundings”, which in practice 

means the channel to which the harbour is connected. It also has the possibility for calculations 

in a shipping lane of 200 km2

. In this application, a standard OECD-EU harbour has been used 

with an exchange volume of 51,117,000 m3

 per tidal period of 12.1 hours. The daily volume of 

discharged treated ballast water and the concentration of the Active Substance and Relevant 

Chemicals are critical input data. The Group recognized that reliable data on daily discharge of 

ballast water is difficult to obtain and that other applicant had used volumes varying 

between 396,000 m3/day (Republic of (Korea) and 50,000 m3/day (Sweden). 

7.1.2 The Group also noted that, according to the authorities of the Port of Rotterdam, the real 

value will be closer to 50,000 than 396,000. It depends on the type of harbour and in 

Rotterdam the intake of ballast water is higher than the discharge, since the majority of ships 

arrive laden. A port that handles mainly tankers that arrive unloaded, may have a higher daily 

discharge than the Port of Rotterdam. The Group noted that this applicant had used the figure 

of 200,000 m3/day. 
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7.2 Calculation of PEC/PNEC ratios 

7.2.1 After request of the Group the Applicant delivered information about the input data for 

the MAM-PEC model, which enabled the Group to re-calculate the PEC data delivered by the 

applicant presented in the table below. 

Chemical PEC 

(μg/L) 

Toxicity

(μg/L) 

Factor 

applied 

PNEC 

(μg/L) 

PEC/PNEC 

1.25 

0.06 

Free Active Chlorine 0.34 (harbour) 

0.017 (Surroundings) 

0.014 (Shipping Lane) 

2.7 10 0.27 

0.05 

0.03 

0.0008 

Tribromomethane 1.28 (Harbour) 

0.036 (Surroundings) 

0.005 (Shipping lane) 

4800 100 48 

0.0001 

0.003 

0.0001 

2,2-Dibromoacetic 

acid 

0.019 (Harbour) 

0.001 (Surroundings) 

0.0007 (Shipping lane) 

6900 1000 6.9 

0.0001 

7.2.2 Based on the delivered information, a final worst case discharge concentration 

of 2.6 mg/L for FAC and under allowance of a degradation rate, the PEC was found to be 0.218. 

This results in a PEC/PNEC of 0.8 and slightly lower PEC/PNEC values for the other substances. 

Based on this, the Group has no concerns regarding long-term environmental aquatic risk of the 

relevant substances. However, the short-term local impact at the point of discharge could be 

significant. 

7.2.3 Further, the Group has concerns regarding treatment of ballast water during discharge 

with max 2 mg/L. With some residual FAC in the ballast water this could well exceed the 

allowable PEC/PNEC. 

7.2.4 The Group requested the measurements of FAC and relevant by-products after storage of 

the treated ballast water for a maximum of two days and a second treatment during discharge. 

7.2.5 For better comparability, the Group would be in favour of the application of the 

commercial harbour scenario within the MAM-PEC model until a better scenario or model is 

available for the application of ballast water discharge. 

8 CONCLUSIONS AND RECOMMENDATIONS

8.1 Risks to safety of the ship 

8.1.1 The Group agreed that the information submitted by the applicant was insufficient to 

characterize the effect of treatment with the proposed electrolytic process and Active Substances 

on the degradation of coatings or the corrosion of materials associated ballast tank, piping and 

fixtures. 

8.1.2 The Group recommends that long term studies, as appropriate, be carried out or otherwise 

documented from literature to quantify, at the treatment and possible exposure concentrations, 

resultant ballast tank coatings degradation and the expected uniform and localized corrosion rates 

on typical marine vessel metallic (e.g., steel, galvanized steel, zinc, stainless steel, etc.) and 

non-metallic materials (e.g., EPDM rubber) materials used for ballast tanks, fixtures and piping. 
GESAMP-BWWG 6/9 

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8.2 Risks to the crew and general public 

8.2.1 The Group concluded that chlorinated and brominated disinfection by-products are the 

toxicological relevant compounds generated by the electrochemical process as they have a 

potential for uptake and human genotoxicity/carcinogenicity concerns; therefore they will have to 

be kept below toxicological critical levels (e.g., bromate <10μg/L; bromoform <100μg/L; 

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

8.2.2 The Group agreed that the human health risk assessment had not been satisfactorily 

provided. Therefore, the Group recommended that for Final Approval, information should be 

submitted concerning: 

 .1 the (M)SDS of the Active Substances and Relevant Chemicals generated by the 

system; and 

 .2 the description and full understanding of the processes and unit operations in 

which human exposure may occur and the human health risk assessment based on 

the human exposure scenario (HES). 

8.3 Risks to the environment 

8.3.1 Having reviewed all of the information submitted with this application, the Group agreed 

that this system will not cause any harm to the environment when carrying the further work 

which is necessary to apply for Final Approval. 

8.4 Recommendations 

8.4.1 Having considered all of the data submitted for Basic Approval, the Group agreed to 

recommend to MEPC that Basic Approval be granted to this system. 

8.4.2 However, the Group wished to inform MEPC that, in order to make such a 

recommendation, it was necessary to make reference to information gained through experience of 

evaluating previous applications as the data submitted with this application were regarded 

as inadequate. The Group recommended that the following aspects should be given due 

consideration if the system has to be reviewed for Final Approval in the future: 

.1 All the topics addressed under Chapter 2 (Completeness of the Dossier as 

mentioned above) have to be addressed by the Applicant carefully. 

.2 The Group noted that the applicant did not provide information concerning the 

Human Exposure Scenario (MEPC 56/2/2, annex 9) and therefore the risk 

characterization for human health could not be adequately performed. 

.3 The Group considered that the organic content of the test water with treated 

natural seawater should be provided for Final Approval. 

.4 The Group considered that the Level of Quantification (LOQ) for the haloacetic 

acids were too high. This may lead to understatement of the potential levels in the 

treated ballast water. This uncertainty should be clarified in additional analyses 

during the full scale testing on land and/or onboard ships by the applicant. 

* * * 
GESAMP-BWWG 6/9 

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Appendix 6.1 

Physical and biological properties of Free Active Chlorine (FAC) in the form of 

hypochlorite ions (primarily sodium hypochlorite) 

1 CHEMICAL IDENTIFICATION

1.1 The Group recognized that this was the Active Substance generated by the system 

(paragraph 3.3.7 of this report). 

1.2 The Group accepted that the FAC is present as hypochlorite in seawater and would be 

interpreted as Total Residual Oxidants (TRO). 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute aquatic toxicity 

Species Effect Value 

(mg/L)

References 

F Oncorhynchus kisutch 96 h LC50 0.032 

C Ceriodaphnia dubia 24 h LC50 0.005 

A Thalassiosira pseudonana 24 h IC50 0.075 

M Crassostrea virginica 96 h EC50 0.023 

RAR Hypochlorite (Ref. 33); Thatcher, 

1978; Taylor, 1993; Gentile et al., 1979; 

Roberts and Gleeson, 1978 

MEPC 57/2/7, annex, p.14, para. 3.1.1 

 F = Fish, C = Crustacea, A = Algae, M = Mollusc 

2.2 Chronic aquatic toxicity 

 Species Effect Value 

(mg/L) 

References 

F Menidia peninsulae 28d NOEC 0.04 

Chlorineproduced 

oxidant 

C Pandalus danae 28d NOEC 0.05 mg/L Free 

Active Chlorine 

A Unknown species 7d NOEC 0.0027 mg/L 

TRO 

M Crassostrea virginica 15d NOEC 0.007 mg/L 

TRO 

RAR Hypochlorite 

(Ref. 33); Goodman, 

1983; Gibson, 1976; 

Cairns, 1990; Liden, 

1980. 

MEPC 57/2/7, annex, 

p.14, para. 3.1.1

 F = Fish, C = Crustacea, A = Algae, M = Mollusc 

2.3 Information on Endocrine Disruption 

The Group noted that no reports indicating that FAC might have any endocrine effects on aquatic 

organisms had been found. The Group agreed that, as with other similar applications there was 

no reason to suspect that the Relevant Chemicals would have any endocrine disrupting effects. 
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2.4 Sediment toxicity/bioavailability/biomagnification/bioconcentration/foodweb-population 

effects 

2.4.1 It was noted that the Log Pow value of hypochlorous acid is -0.87 (estimated) and that of 

sodium hypochlorite -3.42 (estimated), which are both smaller than the criteria of Log Pow=3. 

The Koc value of sodium hypochlorite is 14.3 l/kg (estimated by EPI Suite TM), which is smaller 

than 500 l/kg. 

2.4.2 The Group, therefore, agreed that FAC was neither expected to absorb to sediment nor to 

accumulate in the food web (see also results of MAM-PEC). 

3 MAMMALIAN TOXICITY

3.1 Acute mammalian toxicity 

Exposure Route Value Species References 

Oral LD50 (mg/kg) 850 rat WHO 2000 (Calcium 

hypochlorite 

Dermal LD50 (mg/kg) >10000 rabbit MEPC 57/2/1 

Inhalation LC50 (mg/l/4h) >10.5 rat MEPC 57/2/1

3.1.1 The Group agreed that, according to submitted and existing data (RAR EC, 2007), 

the Group concluded that the acute toxicity of sodium hypochlorite is low by the oral, dermal and 

inhalation routes of exposure. 

3.2 Corrosion/irritation 

 Species Method Results 

(including scores 

where available) 

References 

Skin Rabbit OECD 404 2% slight (1.2) 

20% severe (5.2) 

IUCLID 2000 

Eye Rabbit 5.25% irritant 

0.5% slight irritant 

0.05% NOEC 

Pashley, 1985 

3.2.1 The Group agreed that, according to the presented data, sodium hypochlorite is to be 

regarded as a skin and eye irritant and is classified under GHS as skin corrosive 1B 

(GHS classification, Annex VI, COM (2007) 355 final). 

3.3 Sensitization 

3.3.1 The Group noted that a 2.8% solution of sodium hypochlorite solution was not found to 

be a skin sensitizer in guinea pigs (IUCLID 2000). According to existing data sodium 

hypochlorite does not show a potential to cause delayed contact hypersensitivity 

(draft Risk Assessment Report (RAR) on sodium hypochlorite, EU Assessment 793/93). 
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3.4 Repeated dose toxicity 

Exposure Route Oral 

Exposure Duration 90 days 

Exposure dose 200 mg/l TRO in drinking water 

Species Mouse 

Method 

Results 

NOAEL 50 mg/l (10-12 mg/kg/day) 

NOEL 

Reference Daniel et al. (1991) 

3.5 Chronic and long-term toxicity 

Exposure Route Oral 

Exposure Duration 2 years 

Exposure dose Up to 24.2 mg/kg/day (14.4 in rats, 24.2 in Mouse) 

Species Rat and Mouse 

Method 

Results 

NOAEL 14.4 mg/kg/day 

NOEL 

Reference NTP, 1992 

3.5.1 The Group noted the existing and submitted data and concluded that: 

 .1 the NTP, 1992 is considered to be the key study for deriving a NOEL for risk 

characterization for the oral route; 

 .2 concerning the repeated exposure by dermal route, EC (RAR, 2007), no systemic 

effects were had been seen following dermal exposure to 10000mg/L NaClO. As 

a result, the NOEL of 1% from the study of Kurokawa (1984) was chosen to 

evaluate the local dermal effects; and 

 .3 in evaluating the effects of inhalation exposure, it was proposed to use data from 

chlorine gas. The NOAEL for repeated exposure to chlorine gas is 0.5 ppm in 

studies performed with rhesus monkeys and human volunteers. 

3.6 Development and reproductive toxicity 

Exposure Route Oral 

Exposure Duration 7 generations 

Exposure dose 100 mg TRO/l (drinking water treated with sodium 

hypochlorite) 

Species Rat 

Method 

Results 

NOAEL 14.4 mg/kg/day 

NOEL 

Reference Druckrey, 1968 
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I:\MEPC\58\2-7.doc 

3.6.1 The Group noted that the submitted study (Druckrey, 1968) showed no reproductive or 

teratogenic effects of chlorine. In addition, and according to existing and submitted data, the 

Group concluded that there was insufficient information to draw conclusions about the potential 

for developmental toxicity (EHC 216, WHO, 2000). 

3.7 Carcinogenicity/mutagenicity 

 Species Method 

Details 

Results Reference 

Carcinogenicity Not 

carcinogenic

NTP, 1992 

Mutagenicity Not 

mutagenic

Hayashi, 1988; Meier et al., 

1985 

3.7.1 From the available data the Group concluded that: 

 .1 sodium hypochlorite is not classified by IARC as to its carcinogenicity to humans 

(Group 3); and 

 .2 whilst several studies have shown that sodium hypochlorite produces mutagenic 

responses in bacterial systems and mammalian cells in vitro, there is no evidence 

of activity in mammalian test systems in vivo. 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND ANAEROBIC 

CONDITIONS 

4.1 Environmental fate 

4.1.1 The Group noted that the half-life of hypochlorous acid and hypochlorite ions at pH 7.0 

(main formula is HClO) is about 0.8 hour and the half-life at pH 8.0 (main formula is ClO-

) is 

about 1.4 hour. The A.I.S.E. document (ref.1) reports a half-life of 45-60 minutes. 

4.1.2 In addition, it was noted that, in the presence of organic material, FAC disappears very 

quickly, due to its oxidizing property. The Group, therefore, agreed that the resulting TRO in the 

receiving water is expected to be very low. 

4.2 Partition coefficients 

 Method Results Reference 

Log Pow estimated -3.42 EPI Suite TM

Koc estimated 14.3 l/kg EPI Suite TM 

4.3 Persistence and Identification of Main Metabolites 

4.3.1 The Group noted that Free Active Chlorine degrades in less than an hour and so is not 

expected to be persistent on release into the marine environment. 
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4.4 Reaction with organic matter 

4.4.1 The Group recognized that when FAC reacts with organic material in water, by-products 

such as halomethanes and halogenated acetic acids are formed and that this was consistent with 

the chemical analysis carried out on sea water treated by this system. 

4.5 Potential physical effects on wildlife and benthic habitats 

4.5.1 The Group noted that FAC are highly water-soluble inorganic chemicals (IUCLID, 2000) 

which do not float on the surface or sediment to the bottom. As a result, the Group agreed that 

these are unlikely to have any physical effects on wildlife or benthic habitats. 

4.6 Potential Residues in Seafood 

4.6.1 The Group noted that no reports concerning the persistence of FAC in seafood were 

available. However, due to its low Log Pow, these chemicals are not expected to bioaccumulate 

in seafood. 

4.7 Any known interactive effects 

4.7.1 The Group noted that FAC may generate corrosive gas including gaseous chlorine under 

high temperature or low pH condition (<pH 4) but that these conditions will not occur in the 

environment [or in the ballast water tanks]. 

5 PHYSICAL AND CHEMICAL PROPERTIES 

Physical property Sodium hypochlorite 

CAS number 7681-52-9 

Molecule weight 74.44 

Melting point (°C) -25 

Boiling point (°C) 107 

Flash point (°C) 

Density (kg/dm3) at 25°C 1.23*103 

Vapour pressure @ 20°C (Pa) 1740-2000 

Water solubility (g/L) miscible(293) 

pH in solution 14 

Octanol/water partition coefficient 

(log Pow) 

-0.87 

Dissociation constant (pKa) 7.63 

Corrosivity to material or 

equipment 

Reactivity to container material 

Auto ignition temperature (oC) 

Explosive properties 

Surface tension 

Viscosity 

Oxidation reduction potential 1.7 

Oxidizing properties Strong oxidizing agent 

Viscosity (mPa.s) 2.6 
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6 OTHER INFORMATION 

6.1 PH, salinity, TSS, POC, DOC 

6.1.1 The Group noted that the pH and salinity of the treated ballast water was the same as the 

natural values of the uptake water. The pH varied from 7.4 to 8.0. Salinity varied from 

22-34 PSU. TSS, DOC and POC were analysed in samples taken during the test on killing rates 

in the summer of 2007. All parameters varied highly due to conditions in the harbour through 

tidal movements and ship movements. TSS varied between 20 and 100 mg/l. POC values were 

in the range 0.5 – 29 mg/l and DOC values were in the range of 1.0–52 mg/l. 

6.2 Material Safety Data Sheet provided: No 

6.3 GHS Classification: No 

6.4 Risk Characterization 

6.4.1 Characteristics of the Active Substance 

6.4.1.1 The Group agreed that the Active Substance (Free Active Chlorine) has the following 

characteristics 

Persistent 

(y/n) 

Bioaccumulative

(y/n) 

Toxic (y/n) Reference 

No No Yes MEPC 57/2/7 

6.4.2 Data Input 

6.4.2.1 The Group agreed with the applicant that the following data used to calculate the 

Predicted Environmental Concentration (PEC) was appropriate: 

.1 Load: 334 kg/day (based on 200,000m3

/day and maximum of 1.67 mg/l); 

.2 Half-life: 0.041 days in water; and

.3 The MAM-PEC model calculates for FAC a steady state situation (= PEC) in the 

harbour of 0.34 μg/l and of 0.017 μg/l in the surroundings. The model calculates a 

steady state situation in the shipping lane of 0.014 μg/l. 

6.4.3 Aquatic Toxicity Risk Assessment 

 

6.4.3.1 Using the results from the environmental modelling and the estimated PNEC values 

obtained from the aquatic toxicity testing, the Group agreed on the following PEC/PNEC ratios 

for the Active Substance, Free Active Chlorine: 

 PEC 

(μg/L) 

Toxicity 

(μg/L) 

Factor 

applied 

PNEC 

(μg/L) 

PEC/PNEC 

0.34 (harbour) 

0.017 (Surroundings) 

0.014 (Shipping Lane) 

2.7 10 0.27 

1.25 

0.06 

0.05 
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6.4.3.2 In calculating the above PEC/PNEC ratio for Free Active Chlorine, the Group also 

recalled the following estimations which had been made: 

 .1 0.07 μg/L (MEPC 56/2/2) 

 .2 0.04 μg/L (MEPC 57/2/7, ref. 33) 

 .3 8 μg/L (MEPC 57/2/1) 

* * * 
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Appendix 6.2 

Physical and biological properties of Tribromomethane 

1 CHEMICAL IDENTIFICATION 

1.1 As shown in section 3.4 of the main report. 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute aquatic toxicity 

Species Effect Value 

(mg/L) 

Calculated 

NOEC 

(mg/L) 

References 

F Cyprinodon variegates 96 h LC50 7.1 2.9 

C Daphnia magna 24-48 h LC50 46 <7.8 

A Skeletonema costatum 96 h EC50 12.3 

Ward et al., 1981; 

Heitmuller et al., 1981; 

Ecotox, 2005; 

LeBlanc, 1980 

MEPC 57/2/7, annex, 

p.19, para. 3.2.1

 F = Fish, C = Crustacea, A = Algae 

2.2 Chronic aquatic toxicity 

 Species Effect Value Reference 

F Cyprinodon variegatus 28d NOEC 4.8 mg/l 

C 

A

Ward et al., 1981 

MEPC 57/2/7, annex, 

p.19, para. 3.2.1

2.3 Information on endocrine disruption 

2.3.1 The Group noted that no reports had been found, indicating that tribromomethane might 

have any endocrine effects on aquatic organisms. 

2.4 Sediment toxicity/bioavailability/biomagnification/bioconcentration/food web-population 

effects 

2.4.1 The Group noted that the Log Pow value of tribromomethane is 2.4 (ATDSR, 2005), 

which is smaller than the criteria of Log Pow = 3. The Koc value of tribromomethane 

is 114.8 l/kg (annex 7 to MEPC 56/2/2), which is smaller than 500 l/kg. As a result, the Group 

agreed that tribromomethane is not expected to absorb to sediment or to accumulate in the food 

web. 
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3 MAMMALIAN TOXICITY 

3.1 Acute mammalian toxicity 

 

Exposure Route Value Species References 

Oral LD50 (mg/kg) 1147 Rat Chu et al., 1980 

MEPC 57/2/7, annex, p.19, 

para. 3.2.2 

Dermal LD50

(mg/kg) 

 

Inhalation LC50

(mg/l/4 h) 

>7000 ppm/1/h Dog MEPC 56/2, 

para 2.3.2.2 

MEPC 57/2/7, annex, p.19, 

para. 3.2.1 

 Sub-acute toxicity 

NOAEL oral (mg/kg 

bw/day) 2 weeks 

 

3.1.1 The Group agreed that the LD50 values presented in the submitted studies, indicate that 

bromoform is harmful if swallowed. In addition, and according to GHS classification, 

bromoform is toxic if inhaled. 

3.2 Corrosion/irritation 

 Species Method Results Reference 

Skin Rabbit Moderately 

irritating

Eye Rabbit Moderately 

irritating 

Respiratory 

system 

Unspecified Moderately 

irritating 

Torkelson et al., 1994 

MEPC 57/2/7, annex, 

p.19, para. 3.2.2

3.2.1 According to the data in the above table, the Group noted that bromoform is classified 

under GHS as an eye irritant (eye irritant 2) and a skin irritant (skin irritant 2). 

3.3 Sensitization 

The Group noted that no sensitization data had been reported for tribromomethane. 
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3.4 Repeated dose toxicity 

Exposure Route Oral 

Exposure Duration 13 weeks 

Exposure dose 50 mg/kg/day 

Species Rat 

Method 

Results 

NOAEL 25 mg/kg/d 

NOEL 

Reference NTP, 1989 

3.5 Chronic and long-term toxicity 

Exposure Route ? 

Exposure Duration 1 year 

Exposure dose 6.2-57 mg/kg/d (Rat) 

8.3-73 mg/kg/d (Mouse) 

Species Rat and Mouse 

Method 

Results 

NOAEL <6.2 mg/kg/d 

NOEL <6.2 mg/kg/d

Reference Moore et al., 1994 

MEPC 57/2/7, annex, para. 3.2.2 

3.5.1 From the existing and submitted data, the Group concluded that there are concerns related 

to nephropathy and hepatopathy under repeated exposure to bromoform. 

3.6 Development and reproductive toxicity 

Exposure Route 

Exposure Duration Not given for rat study 

105 d for Mouse study 

Exposure dose 50-200 mg/kg 

Species Rat and Mouse 

Method 

Results foetotoxicity observed in rats 

No fertility effects seen in Mouse study 

NOAEL 

NOEL 

Reference WHO, 2000 

3.6.1 The Group concluded from the submitted and existing information (EHC 216, 2000) that, 

although there were no observed effects on fertility parameters, there may be some reprotoxicity 

concerns (foetotoxicity) related to exposure to bromoform. 
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3.7 Carcinogenicity/mutagenicity 

 Species Method 

Details 

Results References 

Carcinogenicity Human Probable 

Human 

Carcinogen 

U.S. EPA (IRIS) 

MEPC 56/2/7, annex, 

para. 3.2.2 

Mutagenicity Salmonella. 

Mammalian

cells 

Ames test Mixed 

Mixed 

Simmon et al., 1978; 

Simmon et al., 1979; 

NTP, 1989; Rapson 

et al., 1980; Varma 

et al., 1988; Morimoto, 

1983; Fuji et al., 1993; 

Galloways et al., 1985 

3.7.1 The Group evaluated the carcinogenicity and mutagenicity data submitted for bromoform 

and concluded that there are positive animal data indicating that bromoform can cause liver and 

intestinal tumours. 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROVIC CONDITIONS 

4.1 Modes of degradation (abiotic) and persistence 

4.1.1 The Group noted that the rate constant of hydrolysis for tribromomethane is estimated 

at 3.2x10-11/sec (Mabey, W. et al.,1978). 

4.2 Partition coefficients 

 Method Results Reference 

Log Pow observed 2.4 CITI, 1992; Sangster, 1994 

Koc observed 114.8 l/kg MEPC 56/2/2, annex 7 

4.3 Persistence and Identification of Main Metabolites 

4.3.1 The Group noted that tribromomethane is a stable compound in water with an estimated 

half-life of 686 years. 

4.4 Reaction with Organic Matter 

4.4.1 The Group noted that no reports on the reaction of tribromomethane with organic matter 

had been found. 

4.5 Potential physical effects on wildlife and Benthic Habitats 

4.5.1 The Group noted that Tribromomethane has a higher specific gravity than seawater 

(2.890 at 20°C) and a low solubility (3.1 g/l (20°C)). Therefore, according to an evaluation 

based on the GESAMP hazard evaluation (GESAMP, 2002), the compound is classified as 

Rating S (substances having a potential effect on benthic habitats). 
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4.6 Potential Residues in Seafood 

Tribromomethane has a low bioaccumulation potential and therefore it is unlikely that residues 

will be found in seafood (see paragraph 3.2.1). 

5 PHYSICAL AND CHEMICAL PROPERTIES 

Property Value Reference/Comments/Justification 

for missing data 

Melting point (°C) 

Boiling point (°C) 

Flammability (flash point for liquids; °C) Nonflammable 

MEPC 

Density (20°C; kg/m3) 

Vapour pressure (20°C; Pa) 534 

Vapour density (air = 1) 

Water solubility (temp; effect of pH; mg/l) Slightly 

soluble 

pH in solution 

Dissociation constant (pKa) 

Oxidation-reduction potential 

Corrosivity to material or equipment 

Reactivity to container material 

Auto-ignition temperature (°C) 

Explosive properties 

Oxidising properties 

Surface tension 

Viscosity 

Thermal stability and identity of 

breakdown products 

Other physical or chemical properties 

6 OTHER INFORMATION 

6.1 Analytical method for measuring the concentration at environmentally relevant 

concentrations: 

Method GC-MS 

Applicability salt water 

Sensitivity < 0.5 – 0.1 μg/l 

Reference NEN/EN/ISO 15680 

6.2 Material Safety Data Sheet provided: No

6.3 GHS Classification: No
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6.4 Environmental Risk Characterization 

6.4.1 Characterization of the Relevant Chemical (Tribromomethane) 

6.4.1.1 The Group agreed that the Relevant Chemical (Tribromomethane) has the following 

characteristics: 

Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n) Reference 

Yes No No MEPC 57/2/7 

6.4.2 Data Input 

6.4.2.1 The Group agreed with the applicant that the following data used to calculate the 

Predicted Environmental Concentration were appropriate: 

.1 Load: 58 kg/day (based on 200.000 m3/day and maximum of 0.290 mg/l)

.2 Half-life: 340 days in sediment

 .3 The MAM-PEC model calculates for tribromomethane a steady state situation 

(PEC) in the harbour of 1.28 μg/l and of 0.036 μg/l in the surroundings. 

The model calculates a steady state situation in the shipping lane of 0.005 μg/l. 

6.4.3 Aquatic Toxicity Risk Assessment 

6.4.3.1 Using the results from the environmental modeling and the estimated PNEC values 

obtained from the aquatic toxicity testing, the Group agreed ton the following PEC/PNEC ratios 

for the Relevant Chemical, Tribromomethane: 

 PEC 

(μg/L) 

Toxicity 

(μg/L) 

Factor 

applied 

PNEC 

(μg/L) 

PEC/PNEC 

1.28 (Harbour) 

0.036 (Surroundings) 

0.005 (Shipping Lane) 

4800 100 48 

0.03 

0.0008 

0.0001 

6.4.3.2 In calculating the above PEC/PNEC ratio for tribromomethane, the Group also recalled 

the following estimations for PNEC which had been made: 

 .1 7.1 μg/L (MEPC 56/2/2) 

 .2 146 μg/L (MEPC 57/2/7, ref. 33) 

 .3 1.5 μg/L (RIVM, 2005) 

* * * 
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Appendix 6.3 

Physical and biological properties of 2,2 Dibromoacetic Acid 

1 CHEMICAL IDENTIFICATION 

1.1 As shown in section 3.4 of the main report. 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute aquatic toxicity data 

 Species Effect Value Reference 

F Pimephales promelas 96 h LC50 6.9 mg/l Mayes et al, 1985 

C 

A

 F = Fish, C = Crustacea, A = Algae 

2.2 Chronic aquatic toxicity 

The Group noted that no data were available on the chronic aquatic toxicity of 2,2-dibromoacetic 

acid. 

2.3 Information on endocrine disruption 

The Group noted that no reports had been found, indicating that 2,2 dibromoacetic acid might 

have any endocrine effects on aquatic organisms. 

2.4 Sediment toxicity/bioavailability/biomagnification/bioconcentration/food web-population 

effects 

The Log Pow value of 2,2 dibromoacetic acid is 1.22 (observed), which is smaller than the 

criteria of log Pow = 3. The Koc value of 2,2 dibromoacetic is 1.90 l/kg (), which is smaller 

than 500 l/kg. 

The Group, therefore, agreed that 2,2 dibromoacetic acid is not expected to be absorbed onto 

sediment or be accumulated in the food web. 

3 MAMMALIAN TOXICITY 

3.1 Acute mammalian toxicity 

Exposure Route Value Species Reference 

Oral LD50 (mg/kg) 1737 Rat Linder et al., 1994 

Dermal LD50 (mg/kg) 

Inhalation LC50

(mg/l/4 h) 

 
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3.2 Corrosion/irritation 

 Species Method Results Reference 

Skin Corrosive 

Eye Severe 

Lung Severe 

Assumed as a strong acid

3.2.1 The Group noted that, according to the presented data, dibromoacetic acid is considered 

to be corrosive to skin and a sever irritant to the respiratory system and eyes. 

3.3 Sensitization 

3.3.1 The Group noted that no sensitization data had been reported for 2,2 dibromoacetic acid. 

3.4 Repeated dose toxicity 

Exposure Route Oral Oral

Exposure Duration 28d 3 months 

Exposure dose 0-2000 mg/l 

Species Mouse Mouse

Method 

Results No deaths but various effects seen at >500 mg/l 

NOAEL 38 mg/kg/d Not reported 

NOEL Not reported 

Reference WHO, 2004 

3.5 Chronic and long-term toxicity 

Exposure Route Oral Oral

Exposure Duration 2 years 2 years

Exposure dose 0-1000 mg/l 

Species Mouse Rat 

Method 

Results Increased body weights at 50 

and 500 mg/l in males only 

Decrease body weights at 500 

and 1000 mg/l 

NOAEL Not reported Not reported

NOEL Not reported Not reported

Reference NTP, 2005 

3.5.1 From the above data, the Group concluded that there was no relevant toxicological 

concern regarding the repeated exposure to dibromoacetic acid. 
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3.6 Development and reproductive toxicity 

Exposure Route Oral 

Exposure Duration 

Exposure dose 0-250 mg/kg/d 

Species Rat 

Method 

Results Increased E2 at 250 mg/kg/d 

NOAEL 125 mg/kg/d 

NOEL 

Reference Cummings et al. (1998) 

3.6.1 The Group noted, from the submitted data, that whilst some reproductive toxicological 

effects were observed, these were associated with exposure to high doses. 

3.7 Carcinogenicity/mutagenicity 

 Species Method 

Details 

Results Reference 

Carcinogenicity Mouse and 

Rat 

Carcinogenic 

(tumours/cancers 

observed) 

NTP, 2007 

Mutagenicity Salmonella 

typhimurium 

Ames 

test 

Positive at 10 mg/l NTP, 2007; Giller 

et al., 1997 

3.7.1 Relevant adverse effects related to target organs (liver and testes) 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 (WHO Guidelines for Drinking Water Quality, 2003). 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND ANAEROBIC 

CONDITIONS 

4.1 Environmental fate 

4.1 The Group noted that Holmes et al. (2001) had measured the decay rate 

of 2,2 dibromoacetic acid with in vivo and vitro toxicity tests and that they reported a half-life 

of 1.5 hours. 

4.2 Partition coefficients 

 Method Results Reference 

Log Pow estimated 1.22 EPI Suite TM

Koc estimated 1.90 l/kg EPI Suite TM

4.3 Persistence and Identification of Main metabolites 

4.3.1 No data. 
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4.4 Reaction with Organic Matter

4.4.1 The Group noted The 2,2 dibromoacetic acid is highly soluble in water; actually it is 

highly hygroscopic. It, therefore, is not expected to react substantially with organic matter nor 

will it precipitate in wildlife or benthic habitats or accumulate in seafood. 

5 PHYSICAL AND CHEMICAL PROPERTIES 

Property Value Reference/Comments/Justification 

for missing data 

Melting point (°C) 

Boiling point (°C) 

Flammability (flash point for liquids; °C) Nonflammable 

MEPC 57/2/7, annex, para. 3.3.4 

Density (20°C; kg/m3) 

Vapour pressure (20°C; Pa) 0.023 MEPC 57/2/7, annex, para. 3.3.4 

Vapour density (air = 1) 

Water solubility (temp; effect of pH; mg/l) Highly 

soluble 

MEPC 57/2/7, annex, para. 3.3.4 

pH in solution 

Dissociation constant (pKa) 

Oxidation-reduction potential 

Corrosivity to material or equipment 

Reactivity to container material 

Auto-ignition temperature (°C) 

Explosive properties 

Oxidising properties 

Surface tension 

Viscosity 

Thermal stability and identity of 

breakdown products 

Other physical or chemical properties 

6 OTHER INFORMATION 

6.1 Analytical methods for measuring the concentration at environmentally relevant 

concentrations

Method GC-MS 

Applicability salt water 

Sensitivity < 1 μg/l

Reference RPS Laboratories: Halacet_V1 methodology 

6.2 Material Safety Data Sheet provided: No 

6.3 GHS Classification: No
GESAMP-BWWG 6/9 

ANNEX 6 

Page 29 

I:\MEPC\58\2-7.doc 

6.4 EnvironmentaL Risk Characterization 

6.4.1 Characteristics of the Relevant Chemical (2,2-Dibromoacetic Acid) 

6.4.1.1 The Group agreed that the Relevant Chemical (2,2-Dibromoacetic Acid) has the 

following characteristics: 

Persistent 

(y/n) 

Bioaccumulative 

(y/n) 

Toxic 

(y/n) 

Reference 

No No No MEPC 57/2/7 

6.4.2 Data Input

6.4.2.1 The Group agreed with the applicant that the following data, used to calculate the 

Predicted Environmental Concentration (PEC) were appropriate: 

.1 Load: 13 kg/day (based on 200.000 m3/day and maximum of 0.064 mg/L) 

.2 Half-life: 0.0625 day in water

.3 The MAM-PEC model calculates for 2,2 dibromoacetic acid a steady state 

situation (PEC) in the harbour of 0.019 μg/l and of 0.001 μg/l in the surroundings. 

The model calculates a steady state situation in the shipping lane of 0.0007 μg/l. 

6.4.3 Aquatic Toxicity Risk Assessment 

6.4.3.1 Using the results from the environmental modelling and the estimated PNEC values 

obtained from the aquatic toxicity testing, the Group agreed ton the following PEC/PNEC ratios 

for the Relevant Chemical, 2,2-dibromoaceti acid: 

 PEC 

(μg/L) 

Toxicity 

(μg/L) 

Factor 

applied 

PNEC 

(μg/L) 

PEC/PNEC 

0.019 (Harbour) 

0.001 (Surroundings) 

0.0007 (Shipping Lane) 

6900 1000 6.9 

0.003 

0.0001 

0.0001 

6.4.3.2 In calculating the above PEC/PNEC ratio for 2,2-dibromoacetic acid, the Group also 

recalled the following estimations for PNEC which had been made: 

 .1 6.9 μg/L (MEPC 56/2/2); and 

 .2 0.72 μg/L (MEPC 57/2/7, ref. 33) 

*** 

GESAMP-BWWG 6/9 

I:\MEPC\58\2-7.DOC 

ANNEX 7 

REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER MANAGEMENT 

SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES 

Electro-Clean System (ECS) 

Submitted for Final Approval by the Republic of Korea 

0 SUMMARY

0.1 The Group noted that the Electro-Clean System (ECS) uses an electrolytic process to 

effect disinfection. The system produces Active Substances in situ which are neutralized by 

sodium thiosulphate to demand. The Group recognized the importance of the neutralization 

process as an environmental risk mitigation measure. 

0.2 The Group also noted that hydrogen and chlorine gases are produced by the system and 

that the risks associated with these products have been recognized and mitigated by the inclusion 

of monitoring, alarm and shut-down functions to the system. 

0.3 The Group was pleased to find the additional information, provided by the applicant, in 

response to the remarks made in the report of the last evaluation of this system. For example the 

Group noted that this was the first application which it had reviewed which included some 

quantitative human risk assessment. 

0.4 The Group appreciated the attempts by the applicant to provide details of evaluations of 

the various chemicals by employing EUSES 2.1 and MAM-PEC 1.6. Although these tools have 

not been adopted by the Group, it was considered useful to review the results provided. 

0.5 However, the Group expressed its concern that the many data changes and additional 

information provided after the application dossier for Final Approval had been received, made 

review very difficult. 

0.6 The Group noted some deficiencies regarding the compliance with test guidelines of one 

specific part of the toxicity tests (algae) which were possibly due to a lack of consistent 

Quality Assurance. However, taking all of the tests (fish, Daphnids and algae) into account, it 

was agreed that the system would not produce an unreasonable risk to the receiving environment. 

0.7 Having reviewed the additional information provided since the last application 

for Final Approval, the Group agreed to recommend to MEPC that Final Approval of 

the ECS system should be granted subject to the following: 

 .1 maximum allowable dosage of Active Substances

10 mg/ L as TRO which should be monitored and recorded during uptake by TRO 

sensors maintained adequately; 

 .2 maximum allowable discharge concentrations of Active Substances

<0.02 mg/ L as TRO which should be monitored and recorded during discharge by 

TRO sensors maintained adequately; and 

 .3 further corrosion tests being carried out – see section 4.7. 
GESAMP-BWWG 6/9 

ANNEX 7 

Page 2 

I:\MEPC\58\2-7.doc 

1 INTRODUCTION

1.1 The data used to evaluate this system were extracted from that supplied by 

the Republic of Korea in document MEPC 58/2 which was supplemented by additional 

confidential information provided by the applicant. Further information was provided by the 

applicant in response to specific questions posed before and during the meeting. 

1.2 It was noted that Basic Approval for the ECS had been granted by MEPC 54 based on the 

recommendations made by the Group in MEPC 54/2/12. 

1.3 It was recalled that an application for Final Approval of this system had been rejected 

by MEPC 57 based on the Group’s recommendation (MEPC 57/2). 

2 COMPLETENESS OF THE DOSSIER

2.1 The Group recalled that, at its fourth meeting, it had recommended that Final Approval 

should not be granted to ECS as it had identified important information was missing from the 

application. 

2.2 Confidential information supplied in addition to that included in MEPC 58/2

2.2.1 The Group noted that the applicant had provided the following manuals: 

 .1 Cover Manual 

 .2 Non-Confidential Report 

 .3 Appendix I – Recommendations of BESAMP-BWWG and concerns of KOREA 

that submitted the dossier for Final Approval 

 .4 Appendix II – Preliminary report for the Type Approval Test Used by 

Electro-clean Ballast Water Management System 

 .5 Appendix III – Analysis of Active Substances and Relevant Chemicals 

 .6 Appendix IV – Key data summary of Active Substances, Relevant Chemicals and 

Other Components 

 .7 Appendix V – Installation & Operation Manual of Electro-Clean System 

 .8 Appendix VI – MSDS of Active Substances, Relevant Chemicals and Other 

Components 

 .9 Appendix VII-1 – Toxicity Test Report 

 .10 Appendix VII-2 – Toxicity Test Report 

 .11 Appendix VIII – Corrosivity Test Report 

 .12 Appendix 8-I – Corrosivity Test Report 

 .13 Appendix 8-II – Corrosivity Test Report 

 .14 Appendix IX – Data sheet of MAM-PEC and EUSES for Risk Assessment 

 .15 Appendix X – Quality Assurance Project Plan (QAPP) for the full scale testing of 

the Electro-Clean ballast water management system of Techcross Inc. 

 .16 Appendix X, Annex A – References – Volume 1 (A1: bio-Efficacy, A2: Active 

Substances) 

 .17 Appendix X, Annex A – References – Volume 2 (A3: Toxicity) 

 .18 Appendix X, Annex B – Quality Manual of ISO/IEC 17025 System at the South 

Sea Institute of KORDI 

 .19 Appendix XI – Estimated results for ECS treated water by EPI and TOPKAT 
GESAMP-BWWG 6/9 

ANNEX 7 

Page 3 

I:\MEPC\58\2-7.doc 

 .20 Reference 1 (A-C) 

 .21 Reference 2 (E-1) 

 .22 Reference 3 (E-2) 

 .23 Reference 4 (E-3) 

 .24 Reference 5 (E-4) 

 .25 Reference 6 (H) 

 .26 Reference 7 (I-N) 

 .27 Reference 8-I (O) 

 .28 Reference 8-II (O) 

 .29 Reference 9 (R-T) 

 .30 Reference 10 (U-W) 

 .31 Reference 11 (Estimated results for ECS treated water by EPI and TOPKAT) 

 .32 Reference 11-2 (Estimated results for ECS treated water by EPI and TOPKAT) 

 .33 Reference 11-3 (Estimated results for ECS treated water by EPI and TOPKAT) 

3 DESCRIPTION OF THE BWMS

3.1 Overview of the system

3.1.1 The Group noted that the application for Final Approval described the system as 

consisting of: 

 .1 an electrolysis module; 

 .2 a rectifier; 

 .3 a heat-exchanger; 

 .4 a power distributor; 

 .5 a control PC; 

 .6 a neutraliser; and 

 .7 several sensors. 

3.1.2 It was noted that the electrolysis module is installed in the middle of the ballast pipe and 

disinfects micro-organisms in the ballast water. The Rectifier receives AC power from MCC 

and supplies DC power to the electrolysis module while periodically changing the polarity of 

electrodes by the timer setting. When the rectifier is operated, it generates heat, and so 

a Heat-exchanger is used to cool it. The Power distributor supplies power to the ECS 

with 3-phase 440V input power and electricity is supplied to the control PC, rectifier and sensor 

units by the magnet. The controller unit on the distributor switches on the magnet in an 

emergency to prevent problems that may occur in the system. A Control PC is installed in 

ballast room or on the distributor panel and controls ECS. It collects all data-from sensor units 

and all components of ECS- through RTU and controls the ECS with these data. 
GESAMP-BWWG 6/9 

ANNEX 7 

Page 4 

I:\MEPC\58\2-7.doc 

3.1.3 The Neutralisation system is installed in order to decrease TRO concentration by ECS 

before discharging the treated water in ballast tanks. It is connected to inflow neutraliser 

automatically into ballast pipe. The Programmable Logic Controller (PLC) would automatically 

control the amount of neutralizer according to the TRO concentration. ECS is designed to be 

operated automatically, reflecting data from the following sensor units: 

 .1 conductivity sensor; 

 .2 pH sensor; 

 .3 Temperature sensor; 

 .4 TRO sensor; and 

 .5 Gas sensor and Flow meter for H2 and Cl2. 

3.2 Electro-Clean System Process 

3.2.1 The Group noted that the ballast water treatment process of the Electro-Clean System 

(ECS) comprises a series of processes as outlined in the diagram below: 

3.2.2 It was noted that the conductivity of the ballast water is measured at uptake and the 

results sent to the Control PC. The Control PC uses this information to adjust the current needed 

to be supplied to electrolysis module in order to generate a TRO of 10 mg/L to disinfect the 

ballast water. In addition, a TRO sensor is located after the treatment prior to the ballast tank, 

which supplies a feedback control signal to the control PC to further adjust the current needed to 

maintain the TRO concentration at 10 mg/L. This disinfection process includes the part that 

supplies current to the electrodes in the ECS module and the cooler unit (rectifier, power 

distributor and heat-exchanger) that is controlled by the online TRO sensor and control PC. 
GESAMP-BWWG 6/9 

ANNEX 7 

Page 5 

I:\MEPC\58\2-7.doc 

3.2.3 In order to minimize the toxic effects of TRO, the treated water is neutralised, at 

discharge, by sodium thiosulphate and the TRO concentration of neutralised water is checked 

again using the online TRO sensor. 

 Note: sodium bisulphite was reported in the previous application for Final Approval as 

the neutralizing agent. This has been replaced by sodium thiosulphate. 

3.2.4 The Group noted that for the reliability of the systems, all the TRO sensors are located in 

parallel so that the PLC can easily detect the lack of signal or sensor’s malfunctions. 

3.3 Gas detection and hazard mitigation functions 

3.3.1 The Group noted that the ECS included the following safety features: 

 .1 a water leakage detector, which is installed on electrolysis module which, in the 

event of any detected water leakage, operates the alarm system and shuts the 

system down; 

 .2 gas separators are installed on ballast pipe to remove chlorine and hydrogen; 

 .2.1 the Group considered that this facility might also release bromoform to the 

atmosphere thus reducing the level of bromoform in the discharge water; 

 .3 an on-line gas-detector activates an alarm system when the level of hydrogen 

exceeds 3% and activates system shut down at levels exceeding 4%; 

 .3.1 additional information provided by the applicant (e-mail 11/04/08) indicated that 

the system had been changed so that the alarm system is activated at 2% hydrogen 

and the system is shut down automatically when the concentration reaches 3%; 

 .4 on-line gas-detector activates an alarm system when the level of chlorine 

exceeds 0.8 ppm and causes the ECS to shut down at levels exceeding 1 ppm; and 

 .4.1 additional information provided by the applicant (e-mail 11/04/08) indicated that 

the system had been changed so that the alarm system is activated at 0.6 ppm 

chlorine and the system is shut down automatically when the concentration 

reaches 0.8 ppm. 

3.4 Identification of Active Substance (AS), Relevant Chemicals (RC) and Other 

Chemicals (OC)

3.4.1 The Group noted that the applicant had identified the following chemicals as AS, RC 

or OC: 

Chemical name

Control 

water 

(μg/L)

Treated water 

(μg /L) before 

neutralization

Treated water 

(μg /L) after 

neutralization

LOD* 

(μg /L) 

LOQ* 

(μg /L) 

History 

HOCl (OCl-) N.D. 1400 N.D. 10 40 A 

HOBr (OBr-) N.D. 6390 N.D. 2 6 A 

Active 

Substances 

O3 (H2O2) N.D. 478 N.D. 20 60 
GESAMP-BWWG 6/9 

ANNEX 7 

Page 6 

I:\MEPC\58\2-7.doc 

Chemical name

Control 

water 

(μg/L)

Treated water 

(μg /L) before 

neutralization

Treated water 

(μg /L) after 

neutralization

LOD* 

(μg /L) 

LOQ* 

(μg /L) 

History 

2,3-dihydroxybenzoic acid N.D. N.D. N.D. 10 20 

OH2,5-dihydroxybenzoic acid N.D. N.D. N.D. 20 50 

Trichloromethane 0.20 0.12 0.13 0.006 0.02 A 

Dibromomethane N.D. 0.07 0.06 0.006 0.02 

Bromodichloromethane 0.02 0.31 0.12 0.008 0.03 A 

Dibromochloromethane 0.02 14.35 8.04 0.006 0.02 A 

Tribromomethane 0.10 481.67 373.96 0.005 0.02 A 

1,2,3-Trichloropropane N.D. N.D. N.D. 0.006 0.02 

2-Chlorotoluene N.D. N.D. N.D. 0.006 0.02 

4-Chlorotoluene N.D. N.D. N.D. 0.006 0.02 

1,2-Dibromo-3-Chloropropane N.D. N.D. N.D. 0.009 0.03 

1,3,5-Tribromobenzene N.D. N.D. N.D. 0.011 0.03 

1,2,4-Tribromobenzene N.D. N.D. N.D. 0.011 0.03 

Trichloroacetonitrile N.D. N.D. N.D. 0.004 0.01 

Dichloroacetonitrile N.D. N.D. N.D. 0.003 0.01 

Bromochloroacetonitrile N.D. N.D. N.D. 0.004 0.01 

Dibromoacetonitrile 0.16 36.84 21.49 0.003 0.01 

2,4-Dibromophenol 0.01 0.02 0.02 0.002 0.01 

2,6-Dibromophenol 0.01 0.02 0.01 0.002 0.01 

2,4,6-Tribromophenol 0.01 0.28 0.38 0.002 0.01 

2-Chlorophenol N.D. N.D. N.D. 0.003 0.01 

2,4-Dichlorophenol N.D. N.D. N.D. 0.002 0.01 

2,4,6-Trichlorophenol N.D. N.D. N.D. 0.004 0.01 

Pentachlorophenol N.D. N.D. N.D. 0.002 0.01 

Monochloroacetic acid 0.19 1.31 1.26 0.005 0.02 A 

Monobromoacetic acid N.D. 26.33 22.98 0.006 0.02 A 

Relevant 

Chemicals 

Dichloroacetic acid 0.06 0.88 ≤ 0.74 0.010 0.03 A 
GESAMP-BWWG 6/9 

ANNEX 7 

Page 7 

I:\MEPC\58\2-7.doc 

Chemical name

Control 

water 

(μg/L)

Treated water 

(μg /L) before 

neutralization

Treated water 

(μg /L) after 

neutralization

LOD* 

(μg /L) 

LOQ* 

(μg /L) 

History 

Trichloroacetic acid N.D. N.D. N.D. 0.011 0.03 A 

Bromochloroacetic acid N.D. 11.59 7.87 0.011 0.03 A 

Dibromoacetic acid N.D. 270.96 163.38 0.011 0.03 A 

Bromodichloroacetic acid N.D. N.D. N.D. 0.010 0.03 A 

Dibromochloroacetic acid N.D. ≤ 5.61 ≤ 7.00 0.009 0.03 A 

Tribromoacetic acid N.D. ≤289.67 183.41 0.011 0.03 A 

Bromate ion N.D. 41.21 26.18 0.11 0.37 A 

Other 

component Sodium thiosulphate N.A. N.A. 1633 - - 

*

LOQ: Limit of Quantification (SD*10, n=7), *LOD: Limit of Detection (SD*3.14, n=7) = MDL 

 History: A = Identified in last application for Final Approval 

 Shaded chemicals are those which could be detected in the treated ballast water and so 

were considered as potential Relative Chemicals. 

3.4.2 The Group recognized that those chemicals which were deemed to be Active Substances 

could not be identified within the limits of detection, in the treated/neutralized ballast water and 

so did not require a complete Risk Assessment. In addition, it was agreed that the other 

chemicals which could be identified as being present in the treated ballast water above the limits 

of detection (shaded in the above table) should be regarded as Relevant Chemicals which would 

need to be subject to a complete Risk Assessment. 

4 THE APPLICANT’S RESPONSES TO THE CONCERNS OF THE GROUP 

EXPRESSED AT ITS FOURTH MEETING 

4.1 Storage of the neutralizing agent and the control of its addition to the ballast water 

(MEPC 57/2, GESAMP-BWWG 4/9, annex 4, para. 2.3.1) 

4.1.1 The Group noted that the applicant had provided details of how the neutralizing agent 

is stored onboard and is dosed automatically into the ballast pipe under the control of the 

Programmable Logic Controller (PLC) according to the concentration of TRO 

(MEPC 58/2, annex, paragraphs 3.1 and 3.2.1). 

4.2 Had the discharge toxicity tests been conducted on samples drawn from the G8 

land-based efficacy tests as required by G9 

 (MEPC 57/2, GESAMP-BWWG 4/9, annex 4, para. 0.4). 

4.2.1 The Group noted that the discharge toxicity tests had been conducted on samples drawn 

from the G8 land-based efficacy tests (Data supplied by the applicant: Appendix I Folder, 

GESAMP REVIEW, section 1). 
GESAMP-BWWG 6/9 

ANNEX 7 

Page 8 

I:\MEPC\58\2-7.doc 

4.2.2 However, the Group considered that these tests had not been carried out under 

adequate Quality Control for the whole effluent toxicity testing, so that the resultant PNEC 

values calculate from these data could have large uncertainties. It was noted that this comment 

had been made when the previous submission for FA had been considered (MEPC 57/2, annex 7, 

section 7.1.1.1.). 

4.2.3 The Group also recognized that, notwithstanding the test deficiencies of the algal test, the 

fish and daphnia tests were satisfactory and clearly showed no ecotoxicological effects to the 

organisms tested. As the tests were expected to be negative, because of the neutralizing agent, 

the Group decided to accept all of the whole effluent tests as a basis for making its 

recommendations. 

4.3 Concentration of organic matter and salinity of the test samples

4.3.1 The Group recalled that it had considered the concentration of organic matter in the water 

used in the land-based tests to be too low and that this would lead to a reduction in the levels of 

by-products generated by the system (MEPC 57/2, GESAMP-BWWG 4/9, annex 4, para. 0.5). 

4.3.2 In addition, it was recalled that the salinity of the test water samples were not in 

accordance with the standards defined in G9. 

4.3.3 However, it was noted that the applicant had conducted further tests using more realistic 

concentrations of Particulate Organic Content (POC), Dissolved Organic Content (DOC) and 

Total Suspended Solids (TSS) (Data supplied by the applicant: Appendix I Folder, 

GESAMP REVIEW, section 1). 

4.3.4 Details of the salinity and organic content of the test water are shown below: 

Water quality of seawater (Masan Bay) 

Date Sample pH Temp. 

(°C) 

Salinity 

(PSU) 

DO 

(mg/L) 

TSS 

(mg/L) 

DOC 

(mg/L) 

POC 

(mg/L) 

06-06-2007 

Test 

water 

8.0 19.8 33.4 6.9 48.8 1.6 3.3 

20-06-2007 

Test 

water 

8.2 20.5 33.2 7.0 90.3 1.7 10.1 

07-12-2007 

Test 

water 

8.1 9.5 32.7 9.3 40.4 1.6 2.9 

17-12-2007 

Test 

water 

7.9 9.3 32.1 10.1 63.1 2.0 1.7 

16-01-2008 

Test 

water 

8.1 6.9 32.9 10.2 58.5 1.8 1.1 
GESAMP-BWWG 6/9 

ANNEX 7 

Page 9 

I:\MEPC\58\2-7.doc 

Water quality of brackish water (Sumjin Estuary) 

Date Sample pH Temp. 

(°C) 

Salinity 

(PSU) 

DO 

(mg/L) 

TSS 

(mg/L) 

DOC 

(mg/L) 

POC 

(mg/L) 

01-08-2007 

Test 

water 

7.9 27.0 19.3 6.5 52.9 5.4 6.2 

22-08-2007 

Test 

water 

8.3 27.9 18.2 8.5 60.3 6.7 6.0 

29-08-2007 

Test 

water 

7.9 26.5 18.6 7.8 60.3 6.5 5.5 

10-09-2007 

Test 

water 

8.0 23.9 19.2 8.9 63.5 5.7 6.3 

22-10-2007 

Test 

water 

8.0 21.6 20.1 19.1 57.9 6.1 5.8 

20-02-2008 

Test 

water 

8.5 5.9 16.8 11.7 59.5 5.4 6.1 

Additionally, toxicity tests were conducted on 22nd October 2007 and 17th December 2007 with 

discharged water treated with ECS during land-based tests. 

(Refer to Appendix 7: Toxicity Test Report.) 

4.4 Lack of information associated with by-products potentially produced by the system

4.4.1 It was recalled that, previously, the applicant had only identified a limited number of 

by-products which the system could potentially generate compared with similar systems 

considered by the Group and data found in the open literature. In addition, it was recalled 

that the applicant had not provided any information regarding the potential reaction between 

chlorine gas and bromide ions which are an inherent constituent of seawater 

(MEPC 57/2, GESAMP-BWWG 4/9, annex 4, para. 0.6). 

4.4.2 However, the Group noted that the applicant had identified more potential by-products as 

shown under paragraph 4.3 and had also provided the following information related to the 

reaction mechanisms of chloride and bromide ions: 

 .1 active substances like HOCl (OCl– ), HOBr (OBr– ), O3, H2O2 and OH-

 radicals are 

generated by the ECS during its operation. The synergistic effect of these Active 

Substances efficiently removes various micro-organisms in ballast water; 
GESAMP-BWWG 6/9 

ANNEX 7 

Page 10 

I:\MEPC\58\2-7.doc 

 .2 HOCl and OCl– are generated at electrolysis procedure. Chlorine and water react 

to form hypochlorous acid (HOCl) and hydrochloric acid (HCl). In turn, the 

HOCl dissociates into the hypochlorite ion (OCl– ) and the hydrogen ion (H+), 

according to the following reactions: 

 Cl2 + H2O Q HOCl + HCl 

 HOCl Q H+

 + OCl– 

 .3 hypochlorous acid is weak acid (pKa of about 7.5), meaning it dissociates slightly 

into hydrogen and hypochlorite ions. Between a pH of 6.5 and 8.5 this 

dissociation is incomplete and both HOCl and OCl– species are present to some 

extent. Below a pH of 6.5, no dissociation of HOCl occurs, while above a pH 

of 8.5, complete dissociation to OCl– occurs. As the germicidal effects of HOCl 

are much higher than that of OCl-

, chlorination at a lower pH is preferred 

(Alternative Disinfectant EPA, 1999). The OCl– and HOCl species are 

commonly referred to as free chlorine, which is extremely reactive with cell 

components of numerous micro-organisms; 

 .4 bromine occurs naturally in sea water where it is present as bromide salts or 

organic bromine substances. These substances are produced by several sea 

organisms. Bromine is present mostly in the form of soluble salts in seawater, salt 

lakes and brine. Chlorine will also oxidise bromide to form hypobromous acids 

shown in the reactions below: 

 Cl2 + H2O Q HClO + H+ + Cl- 

 HOCl + Br- Q HOBr + Cl-

 .5 hypobromous acid (HOBr) is an effective biocide. The rate of hypobromous acid 

and hypobromite ions is determined by the pH value of the water. When the pH 

value is a between 6.5 and 9 both hypobromous acid and hypobromite ions can be 

found in water (Lenntech, Disinfectants Bromine, Water treatment & air 

purification Holding B.V.); 

 .6 ozone is a stronger and faster-acting oxidiser. Because ozone is an unstable 

molecule, it should be generated at the point of application for use in water 

treatment. It is generally formed by, combining an oxygen atom with an oxygen 

molecule. Ozone is far more efficient in killing bacteria, viruses, spores and cysts 

(Muhammad Arif Malik, Abdul Ghaffar & Salman Akbar Malik, 2000); 

 .7 hydrogen peroxide (H2O2) is a very unstable oxidant. In general these can 

adequately remove micro-organisms. H2O2 is non-persistent, has innocuous or 

even beneficial degradation products, and does not accumulate. Hydrogen 

peroxide is a normal metabolite in nearly all organisms and naturally produced by 

sunlight in water; and 

 .8 the OH- radical is a very reactive oxidative species with half-life in the order of 

milliseconds, thus never leaving the reactor. OH- radical, through the exchange of 

ions, instantaneously disinfect the bacteria and aquatic micro-organisms around it 

(Glaze et al., 1987; Alternative Disinfectant EPA, 1999). 
GESAMP-BWWG 6/9 

ANNEX 7 

Page 11 

I:\MEPC\58\2-7.doc 

4.5 Human exposure to brominated by-products and other volatile substances 

potentially generated by the system

4.5.1 The Group recalled that the previous submission had lacked any data related to the risks 

to humans who might be exposed to brominated by-products and other volatile substances 

(MEPC 57/2, GESAMP-BWWG 4/9, annex 4, para. 0.7). As a result, the Group was unable to 

carry out a full Human Risk Assessment and could only make recommendations to mitigate any 

risks to humans based on a precautionary approach. 

4.5.2 In addition, the Group recalled that, in considering the previous submission by this 

applicant, it had expressed concern that the concentrations of Total Residual Chlorine (TRC), 

formed by this system, largely exceed the limit values established for the discharge of waste 

water from land-based point sources. As the degradation rate of the TRC is so low, 

substantial concentrations of TRC might be expected in the discharged ballast water which is 

of concern as the potential health risks have not been sufficiently characterized 

(MEPC 57/2, GESAMP-BWWG 4/9, Annex 4, para. 9.4.1). 

4.5.3 However, the Group noted that the applicant had prepared various exposure scenarios for 

individual Active Substances, Relevant Chemicals and Other Components. Such scenarios 

assumed that the crew might be exposed to treated ballast water whilst the public might be 

exposed to treated ballast water which had first been neutralized using sodium thiosulphate. 

4.5.4 The Group accepted the results of the EASE/EUSES 2.1 Risk Assessments made by the 

applicant. However, the Group noted that a comprehensive justification for the selection of 

the N(L)OAEL values used in the Risk Assessment (which study, critical effect, etc.) and MOE 

calculations used in the risk characterization were not provided. The Group also recommended 

that the applicant could elaborate further on the relevant human exposure scenarios associated 

with the system through an adequate description of the processes and unit operations where 

worker exposure may occur. 

4.6 Measurement and control mechanisms for hydrogen and chlorine

4.6.1 It was recalled that, whilst the applicant had indicated that the highest levels of hydrogen 

and chlorine measured during tests were 4% and 0.9 ppm respectively, the Group considered that 

adequate measurement and control mechanisms for these chemicals needs to be put in place 

(MEPC 57/2, GESAMP-BWWG 4/9, annex 4, paras. 0.8, 0.12 and 0.13). 

4.6.2 In making such recommendations, the Group had taken into account that 

the Lower Explosion Limit for hydrogen is 4% and the published fifteen minute acute 

human exposure limit for chlorine is 1 ppm and the workplace exposure limit is 0.5 ppm 

(8-hr weighted average). 

4.6.3 The Group noted that the applicant had indicated that monitoring alarm and shut-down 

functions had been included in the system to mitigate the potential risks, details, of which, were 

described in section 4 of appendix 1 of confidential documentation. 

4.6.4 However, it was noted that, for hydrogen, the alarm system was designed to operate at 2% 

and the system would shut down if the level exceeded 3%. In addition, it was noted that, for 

chlorine, the alarm system would operate at 0.6 ppm and the system would shut down at 0.8 ppm. 
GESAMP-BWWG 6/9 

ANNEX 7 

Page 12 

I:\MEPC\58\2-7.doc 

4.6.5 Having taken these factors into account, the Group was satisfied that these facilities 

provided adequate safeguards to ensure that the crew were not exposed to hazardous levels of 

chlorine and the levels of hydrogen would not be hazardous to the ship. 

4.7 Corrosivity testing

4.7.1 The Group recalled that it had, noted that, previously, the applicant had carried out 

corrosion tests using coated test samples and so it was only the coating being tested. This led to 

the concern that the Active Substances, such as chlorine, generated by the system, might lead to 

increased corrosion of the tank and piping (MEPC 57/2, GESAMP-BWWG 4/9, annex 4, 

paragraphs 0.9, 0.14 and 9.4). 

4.7.2 The Group noted, that, in response to these concerns, the applicant had provided the 

following information (Section 5 of Appendix I to supplementary information): 

 .1 electrochemical studies (e.g., potentiostatic tests, potentiodynamic polarization, 

Tafel plot analyses and potential vs. Time studies) on uncoated/coated samples, 

pipe materials, and ballast tank samples were conducted from 10th January 

to 2nd March 2008 with various initial TRO concentrations up to 10 ppm. 

In addition, the ballast tanks in the test barge were inspected after 2 years of 

undefined usage rate to assess the relative coatings damage in the seawater and 

chlorinated seawater. Detailed test report is provided as appendix 8 of the 

application dossier; 

 .2 the uncoated test samples are the substantial materials for ballast tanks and the 

coated test samples are the materials pasted with Zn primer, which was assumed 

to be a zinc rich epoxy primer as opposed to a galvanized coating; 

 .3 the applicant conducted a visual assessment of the corrosion condition of barge 

ballast tanks used to conduct the land based testing. The applicant indicates that 

these tanks were coated with a typical epoxy amine coating 150-200 μm thick, 

operated for two years throughout the testing of their treatment system, but 

the Group noted that no details regarding the cumulative time of exposure to 

treated or control waters were provided nor the corrosion condition of these tanks 

prior to testing. The applicant determined from the inspection of these tanks 

resulted in comparable corrosion on overhead and vertical bulkhead surfaces, but 

that the tank bottom of the control/natural seawater exposed tank had more sever 

corrosion than the chlorinated seawater tanks. The applicant concludes from this 

inspection that chlorination was beneficial to corrosion of the substrate; 

.4 the applicant conducted Tafel plot analyses of polarization curves generated with 

an initial 600 s lag time and subsequent 2 mV/s scan rate on uncoated steel 

samples. From these corrosion potentials and corrosion current densities were 

determined, though the calculation of Tafel slopes were not provided. In this case, 

the corrosion current density is proportional to the corrosion rate as dictated 

by Faraday’s Law. The applicant concluded from these analyses that when TRO 

was 2 ppm, the corrosion current density was rather lower than in seawater, but 

when TRO was 6 and 10 ppm, it was almost same as in seawater. 

Thus, under 10 ppm TRO, corrosivity would be similar or lower than in seawater. 

However, the Group noted that, Tafel analyses are not advisable for assessment of 

long term corrosion rates or in-service performance (note that these were 

conducted in a period of minutes). These are ideal for rudimentary or preliminary 

evaluations of material behaviour or relative corrosivity; 
GESAMP-BWWG 6/9 

ANNEX 7 

Page 13 

I:\MEPC\58\2-7.doc 

.5 Tafel analyses were repeated for samples with a zinc primer. These data exhibited 

the lowest corrosion current density at TRO 2mg/L whereas the highest corrosion 

current density was shown in natural seawater. TRO 6mg/L and 10mg/L have 

lower or similar corrosion current density to natural seawater. Consequently, the 

reaction between Zn primer and TRO causes less remarkable corrosion than 

natural seawater. However, the Group was concerned that these conclusions are 

largely based on averaged polarization curves which exhibited highly disparate 

data. Polarization curves generated with identical conditions resulted in corrosion 

potentials distributed over 200-300 mV vs. Ag/AgCl, likewise corrosion current 

densities are distributed over an order of magnitude. These results are irregular 

and are cause for concern regarding either the experimental procedure or the 

presence of other uncontrolled variables;

 .6 in Tafel analysis of pipe materials by TRO concentrations generated by ECS, 

corrosion potential and corrosion current density have been calculated. Natural 

seawater shows the highest corrosion potential than seawater with TRO 

concentrations. On the other hand, natural seawater and seawater with TRO 

concentrations show almost similar results on corrosion current density. 

Therefore, the applicant considers that TRO has only little effect on corrosivity. 

The Group noted that this conclusion is not in keeping with published long term 

corrosion rates for steel in chlorinated seawater; and 

 .7 in summary, the applicant concluded that, TRO does not cause corrosion as severe 

as natural seawater because seawater with TRO concentrations shows less or 

similar corrosion to natural seawater in electrochemical experiments and Tafel 

analysis. In addition, comparing floors of ballast tanks on the test barge during 

the internal inspection, the tanks with ECS treated water shows even 

less corrosivity than the tanks with natural seawater. 

4.7.3 Having considered this additional information, the Group recognized that the applicant 

had concluded that treatment with the Electro-Clean system would result in comparable or 

reduced corrosion rates on steel and zinc primer coated steel relative to equivalent exposures in 

natural seawater. 

4.7.4 However, the Group determined that this conclusion could not be accepted since it 

contradicts known and published data regarding increased corrosion of carbon steel in 

chlorinated seawater. Furthermore, the electrochemical data are not considered of sufficient 

length or uniformity to support this conclusion. 

4.7.5 The Group noted that the applicant attempted to evaluate long term performance based on 

the inspection of barge ballast tanks used during testing, but the Group agreed that visual 

examination of such broad areas was insufficient, alone, without further detail and usage history. 

The Group recommends a monitoring programme be instigated to provide for the long-term 

inspection of ballast systems using the ECS treatment to ensure that no common obvious or 

extensive corrosion failures occur as a result of using the ballast water treatment system. As this 

type of inspection is difficult to perform properly and quantitatively, it is recommended that such 

inspections should be conducted by trained inspection personnel. The Group further 

recommended that longer term studies on both uniform and localized corrosion rate 

determination of corrosion of carbon steel be performed at the TRO levels in ballast water 

applied by the treatment system. 
GESAMP-BWWG 6/9 

ANNEX 7 

Page 14 

I:\MEPC\58\2-7.doc 

4.8 Neutralization System

4.8.1 It was recalled that, at the time of the previous submission, the applicant had not 

tested the neutralization system under operational conditions and so the Group had 

considered that effective neutralization of TRO in the discharge water could not be ensured 

(MEPC 57/2, GESAMP-BWWG 4/9, annex 4, para. 0.1). 

 Note: In the previous submission the applicant used “TRC” as the parameters for 

Active Substance. However, the Group agreed that the applicant now used “TRO” 

parameters measured by TRO sensors instead of TRC in this FA. 

4.8.2 In addition, the Group recalled that it had observed that mitigation procedures should be 

established to reduce the TRO to levels acceptable to the environment in the case of 

short trips and during the treatment of fresh waters (MEPC 57/2, GESAMP-BWWG 4/9, 

annex 4, para. 9.3). 

4.8.3 Furthermore, it was recalled that it had been of the opinion that the amounts of total 

residual oxidant (TRO) formed during the electrolytic process could result in concentrations in 

the treated ballast water which exceed the limit values established for discharge of waste water 

from land-based point sources. The Group had agreed that, as the degradation rate of TRO is not 

fast enough (1/2 life = 1 day) in ballast tanks to avoid substantial concentrations of TRO in the 

receiving environment for short voyages (1-2 days) and the health risks had not been 

characterized sufficiently. 

4.8.4 The Group noted that, having considered these points, the applicant had provided the 

following information: 

 .1 the initial concentration of TRO produced by the ECS had been reduced 

from 20-30 mg/L to 10 mg/L and, following neutralization process just before 

discharge, TRO is mitigated in the discharged water; 

 .2 the neutralizing agent had been changed from sodium bisulphite, which was stated 

at the previous submission, to sodium thiosulphate; 

 .3 an automatic process, which will be operated at all discharge operation, had been 

installed in order to neutralize any TRO produced by the disinfection process. 

This neutralization process is controlled by the PLC which, automatically controls 

the volume of sodium thiosulphate added according to the actual level of TRO 

determined; and 

 .4 concentrations of TRO present in the discharged ballast water, following this 

automated treatment, were <0.02 mg/L in various TRC range (2.1 -8.2 mg/L) both 

in land-based test and on-board test as shown below: 
GESAMP-BWWG 6/9 

ANNEX 7 

Page 15 

I:\MEPC\58\2-7.doc 

TRO concentration changes through neutralization system after at land-based test 

TRO concentration 

before 

neutralization 

(mg/L) 

Automatic 

neutralization 

system 300m3/hr 

fixed pump flow rate 

(L/h) 

Amount of 

Neutralizer (kg/m3) 

TRO concentration 

after neutralization 

(mg/L) 

2.3 15.0 0.0082 <0.02 

4.3 36.0 0.0196 <0.02 

5.8 39.0 0.0212 <0.02 

8.2 42.0 0.0228 <0.02 

TRO concentration changes through neutralization system at shipboard test 

TRO concentration 

before 

neutralization 

(mg/L) 

Automatic 

neutralization 

system 300m3

/hr 

fixed pump flow rate 

(L/h) 

Amount of 

Neutralizer (kg/m3) 

TRO concentration 

(mg/L) after 

neutralization 

2.1 14.4 0.0078 <0.02 

4.1 33.6 0.0183 <0.02 

5.8 37.8 0.0203 <0.02 

7.8 41.1 0.0223 <0.02 

Refer to Appendix 5: Installation & Operation Manual of Electro-Clean System (ECS). 

4.8.5 Having considered this information, the Group concluded that by installation of this 

neutralization process, the system could mitigate the risk to marine ecosystem significantly not 

only against short voyages. The Group also noted that the reliability of control system including 

that of TRC sensors is important to guarantee the maximum discharge concentration 

of TRC (< 0.02 mg/L). 

4.9 Acute and Chronic Aquatic Toxicity Tests on ECS Treated Ballast Water

4.9.1 The Group recalled that the acute tests, carried out using seawater treated with the ECS, 

had shown that a dilution of more than 100 times had been required in order to remove its acute 

aquatic toxicity properties (MEPC 57/2, GESAMP-BWWG 4/9, annex 4, para. 9.4.2). 
GESAMP-BWWG 6/9 

ANNEX 7 

Page 16 

I:\MEPC\58\2-7.doc 

4.9.2 The Group noted that the applicant had made the following points in relation to this 

observation: 

 .1 further toxicity tests had been carried out using ECS treated and neutralized water: 

 .1 immediately after treatment; and 

 .2 after 72-hour storage in the ballast tank. 

 .2 as neutralization is part of the ECS system, TRO was not detected in the treated 

water which is used for toxicity testing. 

4.9.3 The Group noted that the aquatic toxicity test results, shown in table 5/4 of section 5.2.2.1 

of MEPC 58/2, show that the treated brackish water does not show any acute or chronic toxicity. 

4.10 Risk Assessment Related to Environmental Exposure with an Adequate Model

4.10.1 The Group recalled that it had noticed, in the previous application, that the 

environmental exposure concentrations had, apparently, been based on MAMPEC model 

calculations submitted by a previous applicant. As a result, the Group had requested that the 

input data and model parameters be made available to ascertain the validity of the results 

(MEPC 57/2, GESAMP-BWWG 4/9, annex 4, para. 9.4.3). 

4.10.2 The Group noted that, in response, the applicant had indicated that: 

 .1 as the Active Substances were not detected in the discharged ballast water after 

neutralization, Risk Assessment for such substances were not considered; and 

 .2 the PEC/PNEC ratio for the by-products, after neutralization was <1. 

4.11 Operation of ECS system on Fresh Water

4.11.1 The Group recalled that the previous submission did not include documentation on 

the Active Substance which may be produced by the ECS system in fresh water and so it had 

requested full documentation of the properties of such AS (MEPC 57/2, GESAMP-BWWG 4/9, 

annex 4, para. 9.4.5). 

4.11.2 The Group noted that, in response to this request, the applicant had provided the 

following information: 

Analytical result of Active substances in fresh water 

Chemical name

Control 

water 

(mg/L)

Treated water

(mg/L) before 

neutralisation

Treated water 

(mg/L) after 

neutralisation

LOD* 

(mg/L) 

LOQ* 

(mg/L) 

0.86 N.D. 

0.80 N.D. 

Active 

substances HOCl(OCl-

) N.D. 

0.82 N.D. 

0.01 0.04 
GESAMP-BWWG 6/9 

ANNEX 7 

Page 17 

I:\MEPC\58\2-7.doc 

Chemical name

Control 

water 

(mg/L)

Treated water

(mg/L) before 

neutralisation

Treated water 

(mg/L) after 

neutralisation

LOD* 

(mg/L) 

LOQ* 

(mg/L) 

0.722 N.D. 

HOBr(OBr 0.635 N.D. -) N.D. 

0.582 N.D. 

0.002 0.006 

2.49 N.D. 

O3 (H2O2) N.D. 2.32 N.D. 

2.46 N.D. 

0.02 0.06 

N.D. N.D. 

2,3-dihydroxybenzoic acid N.D. N.D. N.D. 

N.D. N.D. 

0.01 0.02 

N.D. N.D. 

N.D. N.D. 

OH2,5-dihydroxybenzoic 

acid N.D. 

N.D. N.D. 

0.02 0.05 

Operating condition of rectifier at 200 ton/h 

Condition Salinity Conductivity Ampere of rectifier Voltage of rectifier 

2.8‰ 4 mS 3000A 12V 

18‰ 25 mS 1980A 5.2V 

20‰ 28 mS 1950A 4.8V 

Treatment 

capacity: 

200 ton/h 

TRO: 10mg/L 32‰ 45 mS 1950A 4.5V 

Operating condition of rectifier at 300 ton/hr 

Condition Salinity Conductivity Ampere of rectifier Voltage of rectifier 

2.8‰ 4 mS 4500A 14V 

18‰ 25 mS 2950A 6.5V 

20‰ 28 mS 2900A 5.9V 

Treatment 

capacity: 

300 ton/h 

TRO: 10 mg/L 32‰ 45 mS 2900A 5.5V 

The applicant indicated that the ECS generated TRO 10mg/L successfully in saline concentration 

of 2.8‰. 

4.11.3 Having considered this additional information, the Group was satisfied with the 

information provided. 
GESAMP-BWWG 6/9 

ANNEX 7 

Page 18 

I:\MEPC\58\2-7.doc 

4.12 Quality Assurance Plan

4.12.1 The Group recalled that the previous application did not include documentation of 

the Quality Control/Quality Assurance Programme as requested in G9:4.2.4. 

4.12.2 The Group noted that the QAPP for the full-scale testing was provided 

(Additional Data, appendix 10). Also, the Group noted that for the chemical analysis, there are 

adequate data quantity objectives (DQOs) and the results report include the attainment 

against DQOs, such as repeatability for zero blank and calibration control for GC-MS. 

4.12.3 Having considered this information, the Group concluded that, for the toxicity testing, 

the applicant did not provide both adequate QA and QC. As a result, the Group requested MEPC 

to recommend that, for future applications, a thorough review of the QAPP is conducted by the 

appropriate authorities in the Republic of Korea. 

5 RISKS TO THE SAFETY OF THE SHIP, ITS CREW AND THE GENERAL 

PUBLIC

5.1 The Group recognized that the Active Substances and Relevant Chemicals are generated 

in situ and so there were not any associated storage hazards or risks. Nevertheless, it was agreed 

that there are risks associated with the potential exposure of the crew to such products from the 

treated ballast water which need to be taken into account. 

5.2 In addition, it was noted that the neutralizing agent, sodium thiosulphate does need to be 

stored on board and so its hazards and associated risks need to be taken into consideration. 

5.3 In this context the Group recognized that, with the exception of sodium thiosulphate, 

none of the Relevant Chemicals exceeded a concentration of 0.11 mg/L in the treated ballast 

water either before or after neutralization of the Active Substances. Taking this into account and 

being aware that the chemicals have different volatilities, the Group noted that the potential 

health hazards associated to this system would be: 

 .1 acute effects: inhalation toxicity (TROs); corrosiveness (hypochlorite); and 

 .2 long-term effects: mutagenicity/carcinogenicity (brominated and chlorinated DBP). 

5.4 Recognizing that sodium thiosulphate is to be stored on board ship, the Group took 

account of its human toxicological hazards as an undiluted chemical. In this respect, it was noted 

that: 

 .1 the oral toxicity of sodium thiosulphate is low (>2500 mg/kg); 

 .2 no dermal toxicity for sodium thiosulphate was provided. However, the Group 

considered that, based on the oral toxicity, this was expected to be low also; and 

 .3 sodium thiosulphate has irritative properties towards the respiratory tract (MSDS). 

5.5 Notwithstanding these observations, the Group recommended that all normal safety and 

hygiene standards are applied to mitigate the risks of exposure to such chemicals. 
GESAMP-BWWG 6/9 

ANNEX 7 

Page 19 

I:\MEPC\58\2-7.doc 

5.6 Whilst recognizing the lack of real data associated with sodium thiosulphate, the Group 

agreed that the risks to the crew would require mitigating by the inclusion of detailed procedures 

and PPE requirements for the handling and loading of this chemical in the operational manual. 

5.7 Recognizing that there are potential hazards associated with the exposure of the crew to 

treated ballast water, the Group noted that the applicant had applied the European Union System 

for the Evaluation of Substances (EUSES) for estimating the potential risk to both the crew and 

general population who might become exposed to the treated ballast water. The results of this 

application are shown below: 

Risk assessment results for crew 

Potential by-products Ratio MOS/Ref-MOS for vapour 

inhalation 

Hypochlorite 1.29

Hypobromite - 

Ozone - 

Dibromochloromethane 121 

Tribromomethane 333 

Dibromoacetonitrile - 

2,4,6-Tribromophenol 127 

Monochloroacetic acid 33.4 

Monobromoacetic acid 8.82 

Dichloroacetic acid 19.3 

Dibromoacetic acid 38.4 

Bromochloroacetic acid 18.2 

Tribromoacetic acid 88.3 

Bromate ion 2.77 
GESAMP-BWWG 6/9 

ANNEX 7 

Page 20 

I:\MEPC\58\2-7.doc 

Risk assessment results for general population 

Ratio MOS/Ref-MOS 

Local Regional 

Potential by products 

Inhalatory Total 

Exposure Inhalatory Total Exposure 

Dibromochloromethane 2.25E+09 5.34E+03 1.02E+12 9.31E+09 

Tribromomethane 2.23E+06 2.12E+06 6.41E+06 1.28E+07 

Dibromoacetonitrile - - - - 

2,4,6-Tribromophenol 2.59E+10 5.77E+03 1.57E+13 1.6E+10 

Monochloroacetic acid 9.44E+06 4.5E+04 1.56E+11 1.76E+10 

Monobromoacetic acid 1.11E+07 4.69E+03 2.09E+11 2.27E+09 

Dichloroacetic acid 1.46E+08 5.97E+03 8.73E+11 3.37E+09 

Dibromoacetic acid 1.53E+08 2.18E+03 6.68E+11 3.29E+08 

Bromochloroacetic acid 9.31E+06 3.74E+04 1.47E+11 1.87E+10 

Tribromoacetic acid 9.6E+08 1.84E+03 1E+12 1.49E+08 

Sodium thiosulphate - - - - 

 Ref: Additional data, Appendix 9: Data sheet of MAM-PEC and EUSES for risk assessment. 

5.8 Being aware that the results of EUSES risk assessment showed some level of uncertainty 

due to insufficient background calculations provided, the Group noted, however, that 

the Risk Characterization Ratios (RCR) for the Relevant Chemicals identified were above 1 

therefore showing limited risk. However, bromate ions produced values close to 1 in 

the Risk Assessment for the crew and therefore the Group recommended that all the normal safety 

practices should be employed by the crew when entering the ballast tanks. In addition, the Group 

considered that ECS treated ballast water would not pose an undue risk to the general public. 

5.9 With regard to the risk to the crew and the ship from the potential generation of hydrogen 

and/or chlorine gases, the Group was satisfied that the alarm/shut-down facilities built into the 

system were adequate. However, the Group considered that there is a potential for the crew to be 

exposed to THMs in the air emitting from the gas venting system, therefore, the siting of the vent 

outlet requires careful consideration to mitigate this potential risk. 

6 RISKS TO THE ENVIRONMENT 

6.1 Persistence (P), Bioaccumulation (B) and Toxicity (T)

6.1.1 The Group noted that none of the Active Substances or Relevant Chemicals should be 

considered as meeting the PBT criteria defined in G9. 

Ref: Additional information, Appendix IV. 
GESAMP-BWWG 6/9 

ANNEX 7 

Page 21 

I:\MEPC\58\2-7.doc 

PBT character of Active Substances and Relevant Chemicals 

Chemical Persistent 

(y/n) 

Bioaccumulative 

(y/n) 

Toxic 

(y/n) 

Hypochlorous acid 

(No) 

1/2-Life: Not reported 

No 

Log Pow=-2.46 

Yes 

133d NOEC for Ictalurus punctatus, 

0.005mg/l 

Hypobromous 

acid/hypobromite 

No 

1/2-Life: 10.5days 

No 

Log Pow = 1.03 

BCF = 1.236 

(No) 

NOEC = No data 

Hydrogen peroxide 

No 

Anticipated 1/2-Life is 

from hours to a few 

days 

No 

Log Pow <-1.5 

No 

NOEC = 2mg/l ( zebra mussel) 

Ozone 

No 

Decomposes very 

rapidly in natural 

water 

(No) (No) 

NOEC = No data 

Hydroxyl radical 

No 

Evaluated as hydrogen 

No 

Evaluated as 

hydrogen 

No 

Evaluated as hydrogen peroxide 

Trichloromethane 

Yes 

BOD=0% (14days) 

No 

LogPow= 2 

BCF= 1.4-13 

No 

Ceriodaphnia dubia NOEC= 

3.4 mg/l/11 days 

Dibromomethane 

Yes 

1/2 – Life = 22years 

No 

Log Pow = 1.7 

BCF = 4.06 

No 

Cyprinodon variegates NOEC= 

4.8 mg/l/28 days (Tribromomethane) 

Bromodichloromethane 

Yes 

BOD=51-59% 

(28days) 

No 

LogPow= 2 

BCF= 7 

No 

Oryzias latipes NOEC= 

0.78 mg/l/21days 

Dibromochloromethane 

Yes 

Biowin2 (Non-Linear 

Biodeg Probability) = 

0.0000 : Does Not 

Biodegrade Fast / 

Appendix 11, page 

106, 107 

No 

Log Pow = 2.16 

BCF = 9.188 

No 

Daphnia magna NOEC = 

0.063 mg/l/21days (GLP) 

Tribromomethane 

Yes 

Biowin2 (Non-Linear 

Biodeg Probability) = 

0.0000 : Does Not 

Biodegrade Fast / 

Appendix 11, page 

125, 126 

No 

Log Pow = 2.4 

BCF = 14.06 

No 

Cyprinodon variegates NOEC= 

4.8 mg/l/28 days 
GESAMP-BWWG 6/9 

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Page 22 

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Dibromoacetonitrile 

Yes 

Aquatic fate: 5% and 

20% of 

dibromoacetonitrile 

 are lost via hydrolysis 

in 10 days at pH 6 and 

8, respectively 

Biowin2 (Non-Linear 

Biodeg Probability) = 

0.0170 : Does Not 

Biodegrade Fast / 

Appendix 11, page 

144, 145 

No 

Log Pow = 0.47 

BCF = 1.34 

No 

Pimephales promelas LC50= 

0.55 (mg/l/96 h)

2,4-Dibromophenol 

Yes 

BOD=0% (28days) 

No 

Log Pow =3.29 

BCF = 12-40 

No 

Oryzias latipes LC50= 12mg/l/96 h 

2,6-Dibromophenol 

Yes 

Biowin2 (Non-Linear 

Biodeg Probability) = 

0.0467 : Does Not 

Biodegrade Fast / 

Appendix 11, page 

182, 183 

No 

Log Pow =3.29 

BCF = 30.7 

No 

Oryzias latipes LC50= 12mg/l/96 h

(2,4-dibromophenol) 

2,4,6-Tribromophenol 

Yes 

BOD=49 % (28 days) 

1/2 – Life >32 days 

 (Fresh water)

Biowin2 (Non-Linear 

Biodeg Probability) = 

0.0030 : Does Not 

Biodegrade Fast/ 

Appendix 11, page 

202, 203 

No 

Log Pow =3.89 

BCF = 513 

No 

Daphnia magna NOEC= 

0.1 (mg/l/21 days) (GLP) 

Monochloroacetic acid 

No 

BOD=100 % (28 

days) 

Biowin2 (Non-Linear 

Biodeg Probability) = 

0.6123 : Biodegrades 

Fast / page 221, 222 

No 

Log Pow = 0.22 

BCF = 3.162 

No 

Brachydanio rerio LOEC= 

25 (mg/l/28 days) 

Monobromoacetic acid 

No 

BOD=73% 8-10days 

No 

Log Pow = 0.41 

BCF = 3.162 

No 

Daphnia magna NOEC= 

1.6 (mg/l/21days) 

Dichloroacetic acid 

Yes 

Biowin2 (Non-Linear 

Biodeg Probability) = 

0.1318 : Does Not 

Biodegrade Fast / 

Appendix 11, page 

260, 261 

No 

Log Pow = 0.92 

BCF = 3.162 

No 

Nitocra spinipes LC50= 23 (mg/l/96 h) 
GESAMP-BWWG 6/9 

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Page 23 

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Bromochloroacetic acid 

Yes 

Biowin2: 0.5801 NonLinear Model = 

0.0060 : Does Not 

Biodegrade Fast / 

Appendix 11, page 

279, 280 

No 

Log Pow = 0.61 

BCF = 3.162 

No 

Brachydanio rerio LOEC= 

25 (mg/l/28 days) (Monobromoacetic 

acid) 

Dibromoacetic acid 

No 

Biowin2 (Non-Linear 

Biodeg Probability) = 

0.0002 : Does Not 

Biodegrade Fast / 

Appendix 11, page 

298, 299 

No 

Log Pow = 0.70 

BCF = 3.162 

(No) 

Pimephales promelas LC50= 

69 (mg/l/96 h) 

Tribromoacetic acid 

Yes 

Biowin2 (Non-Linear 

Biodeg Probability) = 

0.0000 : Does Not 

Biodegrade Fast 

No 

Log Pow = 1.71 

BCF = 3.162 

(No) 

Pimephales promelas LC50= 

69 (mg/l/96 h) (Dibromoacetic acid) 

Bromate ion 

No 

Biowin2 (Non-Linear 

Biodeg Probability) = 

0.6541 : Biodegrades 

Fast / Appendix 11, 

page 336, 337 

No 

Log Pow = -7.18 

BCF = 3.162 

(No) 

Morone saxatilis LC50= 

404 (mg/l/96 h)

Sodium thiosulphate 

No 

Biowin2 (Non-Linear 

Biodeg Probability) = 

0.6822 : Biodegrades 

Fast / Appendix 11, 

page 354, 355 

No 

Log Pow = -2.32 

BCF = 3.162 

Yes

Oncorhynchus mykiss NOEC= 

600 (mg/l/18 months) 

6.1.2 The Group concluded based on the Table of section 6.1.1 that none of 

the Relevant Chemicals defined in this application should be considered as a PBT-compound. 

6.2 Calculation of PEC/PNEC Ratios 

6.2.1 The Group noted the revised data in the table below provided by the applicant 

on 12/05/08. 

Chemical PEC (Max) 

(mg/L) 

Toxicity 

(mg/L) Factor Applied PNEC (mg/L) 

PEC/PNEC 

(Max) 

Trichloromethane 2.42E-08 3.4 

100 Three L(E)C50 from fresh water or sea 

water (algae, crustaceans and fish) + Three 

long-term NOEC from fresh water (algae, 

crustaceans and fish) 

0.034 7.12E-07 

Dibromomethane 1.47E-08 2.9 

100 Three L(E)C50 from fresh water or sea 

water (algae, crustaceans and fish) + Three 

long-term NOEC from fresh water (algae, 

crustaceans and fish) 

0.029 5.07E-07 
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ANNEX 7 

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I:\MEPC\58\2-7.doc 

Bromodichlorometh

ane 

2.60E-08 0.79 

500 Three L(E)C50 from fresh water or sea 

water (algae, crustaceans and fish) + Two 

long-term NOEC from fresh water 

(crustaceans and fish) 

0.00158 1.65E-05 

Dibromochlorometh

ane 

2.31E-06 0.063 

500 Three L(E)C50 from fresh water or sea 

water (algae, crustaceans and fish) + Two 

long-term NOEC from fresh water (fish and 

crustaceans) 

0.000126 1.83E-02 

Tribromomethane 1.34E-04 2.9 

100 Three L(E)C50 from fresh water or sea 

water (algae, crustaceans and fish) + Three 

long-term NOEC from fresh water (algae, 

crustaceans and fish) 

0.029 4.62E-03 

Dibromoacetonitrile 3.96E-06 0.55 10,000 One L(E)C50 from fresh water or sea 

water (fish) 0.000055 7.20E-02 

2,4-Dibromophenol 9.06E-08 12 10,000 Two L(E)C50 from fresh water or sea 

water (fish and algae) 0.0012 7.55E-05 

2,6-Dibromophenol 4.76E-08 12 10,000 Two L(E)C50 from fresh water or sea 

water (fish and algae) 0.0012 3.97E-05 

2,4,6-

Tribromophenol 4.28E-06 0.1 

1,000 Three L(E)C50 from fresh water or sea 

water (algae, crustaceans and fish) + One 

long-term NOEC from fresh water 

(crustaceans) 

0.0001 4.28E-02 

Monochloroacetic 

acid 2.04E-07 0.033 

500 Three L(E)C50 from fresh water or sea 

water (algae, crustaceans and fish) + Two 

long-term NOEC from fresh water 

(crustaceans and fish) 

0.000066 3.09E-03 

Monobromoacetic 

acid 4.08E-06 1.4 

500 One L(E)C50 from fresh water or sea 

water (algae) + One long-term NOEC from 

fresh water (crustaceans) 

0.0028 1.46E-03 

Dichloroacetic acid 1.97E-07 23 

1,000 One L(E)C50 from fresh water or sea 

water (fish) + One long-term LC50 from 

fresh water (crustaceans) 

0.023 8.57E-06 

Bromochloroacetic 

acid 1.59E-06 0.033 

500 Three L(E)C50 from fresh water or sea 

water (algae, crustaceans and fish) + Two 

long-term NOEC from fresh water 

(crustaceans and fish) 

0.000066 2.41E-02 

Dibromoacetic acid 1.28E-03 69 10,000 One L(E)C50 from fresh water or sea 

water (fish) 0.0069 1.86E-01 

Tribromoacetic acid 1.69E-03 69 10,000 One L(E)C50 from fresh water or sea 

water (fish) 0.0069 2.45E-01 

Bromate ion 6.40E-04 13.6 10,000 Two L(E)C50 from fresh water or sea 

water (algae and fish) 0.00136 4.71E-01 

Sodium thiosulphate 3.99E-02 600 

1,000 Two L(E)C50 from fresh water or sea 

water (crustaceans and fish) + One long-term 

NOEC from fresh water (fish) 

0.6 6.65E-02 

6.2.2 The Group disagreed with some of the assessment factors of the table in section 6.2.1. 

An assessment factor of 10,000 is not needed in these cases. Also the assessment factor 

of 500 lacks a basis as it is not used in the TGD. However, considering that the valid assessment 

factor to be chosen should be less than the factor applied by the applicant the resulting PNEC 

will be higher and therefore, the PEC/PNEC ratio lower than presented in table of section 6.2.1. 
GESAMP-BWWG 6/9 

ANNEX 7 

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6.3 MAM-PEC Model 

6.3.1 The Group welcomed the quantity of input data, which allowed evaluation of the PEC 

data for the relevant by-products. However, some problems arose from the large variety of basic 

physical and chemical data and some errors by the Applicant in transferring the data into the 

model. Degradation rates taken from the EPI suite, for example, were reported as daily 

degradation, whereas they were given an hourly degradation rates from the EPI study. Yet, the 

PEC/PNEC ratios were not affected significantly by these errors. 

7 CONCLUSIONS AND RECOMMENDATIONS 

7.1 Risks to the safety of the ship 

7.2 Risks to the crew and the general public 

7.2.1 The Group agreed that the human health risk assessment provided by the applicant 

showed limited risk towards active substances and relevant chemicals generated by the system. 

However, bromate ions produced values close to 1 in the Risk Assessment for the crew and 

therefore the Group recommended that all the normal safety practices should be employed by the 

crew when entering the ballast tanks. In addition, the Group considered that ECS treated ballast 

water would not pose an undue risk to the general public. 

7.2.2 The Group also recommended that when operating the ECS, the applicant could further 

elaborate on the relevant human exposure scenarios associated to the system through an adequate 

description of the processes and unit operations where worker exposure may occur. 

7.3 Risks to the environment 

7.3.1 Having considered all of the information provided, the Group agreed that this system 

would not pose any undue risk to the environment. 

7.4 Recommendations 

7.4.1 Having reviewed the additional information provided since the last application 

for Final Approval, the Group agreed to recommend to MEPC that Final Approval of 

the ECS system should be granted. 

___________