I:\MEPC\55\2-16.doc 

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

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

INTERNATIONAL MARITIME ORGANIZATION

IMO 

E

MARINE ENVIRONMENT PROTECTION 

COMMITTEE 

55th session 

Agenda item 2 

MEPC 55/2/16

 7 July 2006

 Original: ENGLISH

HARMFUL AQUATIC ORGANISMS IN BALLAST WATER 

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

(GESAMP-BWWG) 

Note by the Secretariat 

SUMMARY

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

GESAMP Ballast Water Working Group (GESAMP-BWWG) and 

includes the evaluation of proposals for the approval of Active 

Substances submitted by Japan, the Republic of Korea and Sweden. 

Action to be taken: Paragraph 4 

Related documents: GESAMP-BWWG 2/9 (attached), MEPC 55/2/1, MEPC 55/2/2,MEPC 55/2/6 

Introduction

1 The second meeting of the GESAMP-BWWG was held from 22 to 26 May 2006, the 

report, of which, is attached to this document with the symbol GESAMP-BWWG 2/9. However, 

this report has still to be reviewed by GESAMP and, should there be any significant amendments 

to it, these will be reported to the Committee accordingly. 

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

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

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

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

3 As instructed by MEPC 54, the Group continued to develop the Draft Methodology for 

Information Gathering and the Conduct of Work of the GESAMP- BWWG, taking into account 

the comments made by the Committee and the submissions by the United States, Japan and the 

European Commission. As a result, several issues were raised which require guidance from the 

Committee. 

Action requested of the Committee

4 The Committee is invited to: 

 .1 agree that all information related to safety and environmental protection, including 

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

non-confidential (paragraphs 2.2 and 5.8.2); 
MEPC 55/2/16 - 2 - 

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 .2 agree with the Working Group’s responses to the comments made in 

MEPC 55/2/1, MEPC 55/2/2 and MEPC 55/2/6 (sections 5.5, 5.6 and 5.7); 

 .3 develop criteria which would specify how chemicals used in the treatment of 

ballast water can be handled and stored on board ship (paragraphs 5.8.4 to 5.8.6); 

 .4 develop a suitable Emission Scenario Document (ESD) to be used by applicants 

and the Group for the Risk Assessment of chemicals associated with ballast water 

treatment, particularly with regard to calculating the Predicted Environmental 

Concentration (PEC) (paragraphs 5.8.8 to 5.8.10); 

 .5 urge applicants to submit their applications in the standardized format indicated in 

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

GESAMP-BWWG (paragraphs 6.1.2 to 6.1.4 and Annex 4); 

 .6 advise the Group whether it should consider full-scale operational risks and, if so, 

which scenarios for the discharge of treated ballast water would be relevant and 

how should they be assessed (paragraphs 6.1.5 and 6.1.6): 

 .7 agree that the Group should not be requested to evaluate conceptual systems that 

do not include details of how the system would be working in practice 

(paragraph 6.2.1); 

 .8 agree that all possible chemicals produced by a proposed system should be 

considered by the Group in order to evaluate the risks associated with long-term, 

high volume, regular discharges into the marine environment and that the 

Draft Methodology should be amended to reflect this (paragraphs 7.3 and 7.4); 

 .9 agree with the proposed schedule of 19 to 23 February 2007 for the third meeting 

of the Group (paragraph 8.3); 

 .10 indicate to Administrations that the deadline for submissions to the third meeting 

of the BWWG is 15 December 2006 (paragraph 8.4); 

 .11 agree that Basic Approval should be granted to the system described in 

MEPC 55/2 (Japan) for further prototype testing and development and that the 

various concerns addressed by the Group should be addressed (Annex 5 and, in 

particular section 0); 

 .12 agree that Basic Approval should not be given to the system described in 

MEPC 55/2/3 (Republic of Korea) for the reasons given in Annex 6; and 

 .13 agree that Basic Approval should be granted to the system described in 

MEPC 55/2/4 (Sweden) for further prototype testing and development and that the 

various concerns addressed by the Group should be addressed (Annex 7 and, in 

particular, section 0). 

***
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GESAMP-BALLAST WATER WORKING 

GROUP 

2nd session 

Agenda item 9 

GESAMP-BWWG 2/9

 25 May 2006

 Original: ENGLISH

REPORT OF THE SECOND MEETING OF THE GESAMP-BALLAST WATER 

WORKING GROUP (GESAMP-BWWG) 

Table of Contents 

Section Page Nos. 

 

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

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

3 OUTCOME OF MEPC 54...................................................... 4 

4 TERMS OF REFERENCE ............................................................... 4 

5 DEVELOPMENT OF THE DRAFT METHODOLOGY FOR 

INFORMATION GATHERING AND THE CONDUCT OF 

WORK OF GESAMP-BWWG......................................................... 4-10 

6 REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE 

SUBSTANCES – SUBMITTED BY JAPAN, THE REPUBLIC 

OF KOREA AND SWEDEN ........................................................ 10-12 

7 CONSIDERATION OF QUERIES FROM MEMBERS AND 

INDUSTRY ...................................................................... 12 

8 FUTURE WORK PROGRAMME AND TENTATIVE DATE 

FOR THE NEXT MEETING ................................................... 12-13 

9 CONSIDERATION AND ADOPTION OF THE REPORT ......... 13 

ANNEXES 

ANNEX 1 LIST OF MEMBERS ATTENDING THE SECOND SESSION OF THE 

GESAMP-BWWG 

ANNEX 2 AGENDA FOR THE SECOND SESSION OF THE GESAMP-BWWG 

ANNEX 3 TERMS OF REFERENCE FOR THE GESAMP-BWWG 

ANNEX 4 DRAFT METHODOLOGY FOR INFORMATION GATHERING AND THE 

CONDUCT OF WORK OF GESAMP-BWWG 
GESAMP-BWWG 2/9 - 2 - 

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ANNEX 5 REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES – 

SUBMITTED BY JAPAN 

ANNEX 6 REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES – 

SUBMITTED BY REPUBLIC OF KOREA 

ANNEX 7 REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES – 

SUBMITTED BY SWEDEN 

ANNEX 8 TIMETABLE FOR ACTIVITIES RELATED TO THE 3RD MEETING OF THE 

GESAMP-BWWG 
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1 INTRODUCTION 

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

held at IMO Headquarters, London, from 22 to 26 May 2006, under the chairmanship of 

Mr Finn Pedersen. A list of members attending this meeting is shown in annex 1, and the 

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

1.2 The meeting was opened by Mr. J-C. Sainlos, MED Director, who informed the Group on 

the volume of work for this session and encouraged the participants to do their utmost to try to 

evaluate all the submissions if possible. However, he advised the Group that all concerned were 

aware of time limitations and the Group should not rush its proceedings to the detriment of 

scientific rigour. Mr. René Coenen, IMO Technical Secretary of GESAMP, reported on the 

contractual arrangements and invited the Group to agree upon criteria for identifying alternate 

members that could be invited to participate should any of the existing members become 

unavailable. Mr Dandu Pughiuc, Head of the IMO’s Office for Ballast Water Management, 

briefed the Group on the outcome of MEPC 54 regarding Ballast Water Management Systems 

that make use of Active Substances and the specific decisions concerning the work of the Group. 

1.3 The Chairman of GESAMP-BWWG briefly reported on the procedure for approving the 

report by GESAMP and on his participation in MEPC 54 and indicated that apart from reviewing 

the proposals for approval of Active Substances, the Group was tasked to continue the 

development of the Draft Methodology for information gathering and conduct of work taking 

into account comments made by the Committee and further proposals from the Member States. 

2 ISSUES OF CONFIDENTIALITY 

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

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

Sweden. The Secretariat informed the Group that the non-confidential parts of the submissions 

had been circulated as MEPC documents and emphasized that members of the Group were 

requested to keep the data contained in the application dossiers confidential to protect the 

commercial interests of the manufacturers. 

2.2 When evaluating an application, the Group felt that it should have the right to base its 

evaluation on any available information and to use this information for justifying its conclusions 

and recommendations irrespective of confidentiality issues. While the Group agreed that the 

details of the functioning of the Ballast Water Management System (BWMS) must be regarded 

as confidential to protect the rights of the manufacturer, it was considered that all the information 

related to physical properties, environmental fate and toxicity should be treated as nonconfidential. However, the Group recommended that the Organization, prior to submission of the 

Groups evaluation report to the MEPC, consults with the Member of the Organization having 

proposed the Ballast Water Management System. In cases where the evaluation report contains 

confidential information, the Organization should decide on the future procedures. The Group 

distinguished between requirements for confidentiality in G9 and the copyright applied to various 

studies and reports used in the preparation of the application dossier. 

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

application, the Organization may provide the name and address of the national Administration 

that originally submitted the application for approval, which could then respond, as it feels 

appropriate. 
GESAMP-BWWG 2/9 - 4 - 

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3 OUTCOME OF MEPC 54

3.1 A comprehensive introduction of the work carried out by relevant IMO bodies in the 

period from the first meeting of the Group was provided by the Secretariat (document 

GESAMP-BWWG 2/3). Particular emphasis was placed on the decisions of MEPC 54 related to 

the development of the Draft Methodology for information gathering and method of work of the 

GESAMP-BWWG and the Group was requested to: 

.1 further consider the document MEPC 54/2/6 (European Commission) with a view 

to identify inconsistencies with G9 and advise MEPC 55 accordingly; 

.2 consider the use of data waivers when preparing the application dossier and advise 

MEPC 55 accordingly; and 

.3 continue the development of the Draft Methodology during the 2nd meeting of the 

Group. 

3.2 The Group was invited to consider, under agenda item 5, the comments and proposals 

contained in documents MEPC 55/2/1 (United States), MEPC 55/2/2 (Japan) and MEPC 55/2/6 

(European Commission), and take action as appropriate. 

3.3 The Group was also invited to consider the questions addressed by IUCN and respond to 

the questions under agenda item 7. 

3.4 Finally, the Group was invited to reconsider the work programme, time line and number 

of application documents that could be evaluated in one session in the light of the experience 

gained and advise the Committee accordingly. 

4 TERMS OF REFERENCE 

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

MEPC 54 as contained in annex 3 of this report and decided to request further clarification from 

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

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

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

Methodology of information gathering and the conduct of work. 

5 DEVELOPMENT OF THE DRAFT METHODOLOGY FOR INFORMATION 

GATHERING AND THE CONDUCT OF WORK OF GESAMP-BWWG

5.1 The Group recalled that, during its first meeting and under severe time constraints, it had 

developed the draft Methodology for information gathering and the conduct of its work. 

5.2 It was noted that the report of its first meeting, which included such draft methodology, 

had been submitted to IMO’s Marine Environment Protection Committee (MEPC) as 

MEPC 54/2/12. 

5.3 The Group noted the comments on its draft methodology, which had been submitted to 

the fifty-fifth session of MEPC by the United States (MEPC 55/2/1), Japan (MEPC 55/2/2) and 

the European Commission (MEPC 55/2/6). 
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5.4 Having considered these comments in detail, the Group made the points identified in the 

following paragraphs of this section. 

5.5 Comments submitted by the United States (MEPC 55/2/1) 

5.5.1 The Group fully supported the view that transparency is important in both the Group’s 

working procedures and its deliberations in order to allow MEPC to make well informed 

judgements based on the Group’s recommendations. In this context, the Group recognized that 

any recommendation made to the Committee needed to be supported by appropriate data. 

(MEPC 55/2/1, paragraph 4). 

5.5.2 It was recognized that the Group had been selected by GESAMP which also held the CV 

of each of the members. Each member of the Group agreed that the CVs could be made 

available to any Member State on request to the GESAMP IMO Technical Secretary 

(MEPC 55/2/1, paragraph 4). 

5.5.3 Whilst the Group anticipated that its role might be to confirm and validate the 

Administration’s assessment of the proposed Active Substances/Preparations for use in the 

treatment of ballast water, it wished to emphasize its independent scientific role which allows it 

to make any recommendations that are scientifically based as appropriate. In this respect, the 

Group urged Member States submitting applications to present an initial Risk Assessment, which 

would facilitate the development of recommendations to MEPC. (MEPC 55/2/1, paragraph 5). 

5.5.4 Whilst recognizing its role is purely advisory, the Group agreed that, if it is going to 

provide MEPC with well informed, meaningful recommendations it would only be able to do this 

if appropriate data are provided. In line with its recommendatory function, the Group amended 

the text of its draft methodology, replacing demands such as “must” and “required” with less 

specific terminology such as “should”. However, in an attempt to assist those Governments and 

industry submitting proposals, it was considered important to make it clear that, without the 

appropriate and correct information, it may not be possible for the Group to assess the BWMS 

sufficiently, in order to allow an informed recommendation to be made to MEPC. (MEPC 55/2/1, 

paragraph 6). 

5.5.5 As indicated in MEPC 55/2/1, paragraph 7, and in order to prevent any misunderstanding 

with respect to testing methodologies, the Group agreed to amend the first sentence of 

paragraph 2.5.1 to: 

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

or equivalents). 

and to introduce a new paragraph 3.0.5 which reads: 

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

purpose of providing guidance to an Administration on possible methods that may be 

considered. Any other internationally recognised test method may also be used as well. 

5.5.6 The Group recalled that, in accordance with G9 the evaluation should consider Active 

Substances, Preparations including any of its components and Relevant Chemicals. 

(MEPC 55/2/1, paragraph 8). In addition, the Group agreed to the following interpretations of 

the definitions and requested MEPC to endorse this understanding: 
GESAMP-BWWG 2/9 - 6 - 

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 .1 Preparation, as defined in G9, should be limited to the first sentence only, which 

would be in line with typical definitions used in chemicals legislation and with the 

similar definition of Mixture used in the Globally Harmonized System (GHS) as 

shown below for comparison: 

 Mixture means a mixture or solution composed of two or more substances in 

which they do not react; and 

 .2 that the definition of Relevant Chemicals in G9, should be transformation and 

reaction products produced during and after employment of the BWMS. 

5.5.7 The Group recognized the concerns expressed about lack of data with missing 

justifications causing the Group to state that “in general it would not allow any approval”. The 

Group agreed that this statement was intended to be helpful to the submitting body as it is 

important to distinguish between missing essential data and data that are not relevant or practical 

to generate. However, in order to overcome this dilemma, it was agreed to amend the text to 

reflect the fact that lack of data with missing justification would make it difficult for the Group to 

make a meaningful recommendation to MEPC. (MEPC 55/2/1, paragraph 9). 

5.5.8 The Group noted that references to data waiver did not appear for all data and agreed to 

add such references into the appropriate places in the draft methodology (MEPC 55/2/1, 

paragraph 11). 

5.5.9 The Group agreed to remove: 

 .1 General obligations of the Convention; and 

 .2 Experimental application period. 

 and to add: 

 .1 Active Substance; 

 .2 Preparation; 

 .3 Other components of a preparation; and 

 .4 Relevant Chemicals. 

 to the Definitions section of the Methodology. 

5.5.10 Whilst recognizing that G9 does not make any reference to shipboard experiments, the 

Group understood that, following Basic Approval, further tests might be carried out using one or 

a few ships to ascertain both the practical functioning of the BWMS and the safety and 

environmental affects of the system submitted for approval. However, the Group agreed that, if a 

recommendation for Basic Approval would be subject to certain concerns being addressed, it 

would be important that such concerns had been properly considered by the Administration prior 

to further development of the system onboard ships and to Final Approval being considered 

(MEPC 55/2/1, paragraphs 13 and 14). 
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5.6 Comments submitted by Japan (MEPC 55/2/2) 

5.6.1 The Group recognized the point, made by Japan in MEPC 55/2/2, paragraph 4, that 

short-term assessment is also very important in the effect assessment of the Active Substances 

and Relevant Chemicals. 

5.6.2 However, the Group agreed that more time was necessary to consider this point in detail 

(MEPC 55/2/2, paragraph 5). 

5.7 Comments submitted by the European Commission (MEPC 55/2/6) 

5.7.1 The Group recognized that it had been charged with developing a methodology for its 

scientific assessment that would allow this to be undertaken in a transparent way and requested 

MEPC to endorse this methodology. (MEPC 55/2/6, paragraph 4). 

5.7.2 It was agreed that it was impractical for the Group to list all information submitted but 

that it would be useful as part of the submission made by the applicant. However, it was agreed 

that any additional data submitted or obtained and used by the Group in its assessment should be 

documented in its report to MEPC (MEPC 55/2/6, paragraph 6). In addition, it was emphasized 

the need for the deadline of submissions to MEPC to allow time for comments to be made by 

third parties that can be taken into account by the Group. 

5.7.3 The Group recognized the opinions related to the mandatory requirement for certain 

information (MEPC 55/2/6, paragraphs 7-10) and agreed that where the Group needs certain 

information to reach a scientific opinion, this should be made compulsory and requested MEPC 

to consider changing G9 to reflect this. 

5.7.4 The Group agreed that, when the PEC/PNEC ratio is >1, this would not necessarily mean 

that a product could not be recommended for Basic Approval but a detailed analysis would need 

to be carried out on a case-by-case basis if this result is to be overridden (MEPC 55/2/6, 

paragraph 16). 

5.7.5 The Group agreed that it would be useful to know the bioaccumulation potential of 

chemicals produced in the treatment of ballast water, especially for halogenated organic 

compounds and that analytical as well as test methods are available for this purpose. However, it 

was noted that G9 (paragraphs 5.3.1 and 5.3.7) did not require this aspect to be taken into 

account in the methodology (MEPC 55/2/6, paragraphs 17-19). 

5.7.6 The Group changed the text of the preambular paragraph as proposed. (MEPC 55/2/6, 

paragraph 20). 

5.7.7 The Group considered the proposals for the definitions of Basic Approval and Final 

Approval and expressed concern over the use of the phrase possible unacceptable adverse effects 

in the definition of Basic Approval. Instead, the original phrase a potential for unreasonable risk

was preferred as it allowed for suitable precautions to be put in place in order to permit the 

product to be used. (MEPC 55/2/6, paragraph 21). Furthermore, it was not clear to the Group 

whether recommendations for Basic Approval should only consider the use of the BWMS for 

development and prototype testing, or whether also the possible full-scale deployment onboard 

ships should be considered. This issue is further discussed in paragraphs 5.8.7 to 5.8.8. 
GESAMP-BWWG 2/9 - 8 - 

I:\MEPC\55\2-16.doc 

5.7.8 In addition, it was noted that neither of these definitions had been included in G9 and the 

Group requested that they should be added so that they can simply be reflected in the Group’s 

Draft Methodology. 

5.7.9 The Group recognized that the paragraph: 

 “A comprehensive report ........for basic approval.” 

was not appropriately placed under the list of definitions and deleted it as the content was already 

reflected elsewhere in the Draft Methodology (MEPC 55/2/6, paragraph 22). 

5.7.10 The Group agreed that all results of effect and exposure assessments with the related 

uncertainty analysis should be added to the list of non-confidential data in paragraph 2.4 

(MEPC 54/2/12, paragraph 23). The Group also agreed that Relevant Chemicals (including byand end-products) formed during or after use of the BWMS, including their physico-chemical, 

human health and environmental properties should not be considered as confidential. 

5.7.11 The Group recognized that, using the highest toxicity (e.g., lowest LC50 value) from a 

range of reported values, might be regarded as taking the safest approach. However, the point 

was made that an appraisal of the data and its sources sometimes enables the experts to identify 

values that might be regarded as outliers or inappropriate. Therefore, a Weight of Evidence 

approach should be used for deciding on the most appropriate values for use in the effect and risk 

assessment and is not to be seen as a probabilistic approach (MEPC 55/2/6, paragraph 24). 

5.7.12 The Group recognized that, in general, there is not much difference in sensitivity to 

chemicals between fresh water and marine organisms within the same taxonomical groups and 

agreed to delete the footnote related to paragraph 3.2.1 of the Draft Methodology as shown in 

MEPC 54/2/12. However, the Group also recognized that some important groups of organisms, 

which are present in the marine environment, are not present in freshwater (e.g., rotifers, 

echinoderms). It was agreed that these groups need to be considered separately whilst 

recognizing that this is done to some extent by the use of an appropriate Assessment Factor in the 

Risk Assessment (MEPC 55/2/6, paragraph 26). 

5.7.13 The Group considered the proposal to use a log Kow >3 instead of log Kow >5 as a trigger 

value for deciding when sediment toxicity testing would be appropriate and noted that the value 

used in the EU TGD was >3 and so agreed to amend the methodology accordingly 

(MEPC 55/2/6, paragraph 27). 

5.7.14 The Group agreed with the editorial changes proposed in MEPC 55/2/6, paragraphs 28, 

29, 30, 33, 34, 35, 36, 37, 39, 42, 43. 

5.7.15 The Group considered the proposal to update the text on bioaccumulation, partition 

coefficient and octanol/water partition coefficient and amended the section appropriately 

(MEPC 55/2/6, paragraphs 31-32). 

5.7.16 With regard to the criteria for the identification of PBT substances, the Group recognised 

that in the EU, the Toxicity criterion also includes CMR or endocrine disrupting effects. 

However, as this is not included in the Procedure G9, it was considered that they could not be 

added to the Draft Methodology of the Group (MEPC 55/2/6, paragraph 38). The Group, 

however, would welcome such an amendment of G9. 
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5.7.17 Nevertheless, the Group agreed that the reference to Log Pow and BCF in the G9 criteria 

were probably incorrectly reported as it would mean that, even if a BCF value had been 

experimentally determined, this would be overridden if the product had a Log Pow of >3. As a 

result, the Group agreed that the criteria should be understood as Experimentally determined 

BCF>2000 or, if no experimental BCF has been determined, Log Pow ≥ 3 and amended the text 

of the Draft Methodology accordingly. 

5.8 Other issues discussed 

5.8.1 In addition to the specific points raised in the various submissions to MEPC, the Group 

raised the following issues which it requested MEPC to consider and decide as appropriate: 

5.8.2 In considering the matter of confidentiality, the Group agreed that all data related to 

safety and environmental protection should be regarded as non-confidential. It was agreed that 

this should include specific toxicity data generated under the ownership of the applicant. 

5.8.3 Notwithstanding this view, the Group noted that its evaluation report would be sent to the 

applicant so that they could indicate whether there are any confidential aspects which need to be 

removed prior to submitting the report to MEPC. 

5.8.4 The Group recognized that there were no safety criteria, based on toxicological and/or 

physical properties, for making recommendations on the safe handling of chemicals employed in 

systems for treating ballast water. It was emphasized that, as such, chemicals are not simply 

cargoes, ships carrying them should be regarded more like a workplace environment and employ 

necessary measures to protect the crew. In addition, it was recognized that, where BWMSs are 

employed on passenger ships, special considerations would need to be taken into account in order 

to ensure the safety of such passengers. 

5.8.5 In this context, it was recognized that the volumes of any chemicals employed would 

vary, not only with the type of Management System, but also with the type of ship. Whilst a 

passenger ship might only require sufficient ballast water to compensate for the fuel being used, 

cargo ships might require much more ballast water to compensate for the state of loading of the 

ship. 

5.8.6 It was recognized that the degree of hazard presented by any chemicals involved and the 

amount required to treat the ballast water might vary considerably therefore, MEPC was 

requested to consider developing criteria which would specify how such chemicals would be 

handled and stored on board (cf., IMDG Code, IBC Code) and whether some chemicals might 

not be allowed at all on certain types of ships e.g., passenger ships. 

5.8.7 In addition to addressing the points raised by the United States, Japan and the EU, the 

Group expressed concerns about the definition of Basic Approval and Final Approval. It was 

recognized that a Basic Approval, as described in the definition, proposed by the EC 

(MEPC 55/2/6), that would only consider controlled discharges in relation to the further 

development and prototype testing could be considered by the Group when information on 

discharge conditions are provided. However, recommendations regarding Basic Approval for 

further development and prototype testing could not be seen as a prejudice for a Final Approval. 

For this, an assessment of environmental concentrations resulting from discharges under realistic 

conditions would be needed. However, the Group is not in possession of information on typical 

discharge situations that allows it to conduct such assessments. 
GESAMP-BWWG 2/9 - 10 - 

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5.8.8 As a result, the Group wanted to reiterate its request to MEPC (MEPC 54/21, 

paragraph 2.12) to indicate the basis of the exposure and risk assessment, preferably in the form 

of a suitable Emission Scenario Document (ESD), which should be adopted by MEPC and 

should specify, for a suitable number of realistic scenarios: 

 .1 the number of ships discharging ballast water into the aquatic environment 

including volume, duration and frequency; 

 .2 the dimensions of the receiving environment; 

 .3 the type of environment e.g., open or closed; 

 .4 the exchange of water in the environment; 

 .5 the water salinity range; 

 .6 the pH range of the water; and 

 .7 the concentration range of organic material. 

5.8.9 However, the Group considered that, even if such an ESD were available, it has no 

capacity to develop a suitable model that could be used for estimating environmental exposure 

concentrations or environmental dilution, and would consequently welcome the development and 

submission of such models, agreed by MEPC, to be used by applicants and the Group in its 

assessment of applications. 

5.8.10 In this context, the Group was aware of the existence of models that might be suitable, or 

might have possibilities to make them suitable, for the intended use. However, the Group 

emphasised that potential models would need to be evaluated for their pros and cons prior to 

acceptance. 

6 REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES –

SUBMITTED BY JAPAN, THE REPUBLIC OF KOREA AND SWEDEN 

6.1 General overview 

6.1.1 The Group noted that submissions had been received from Japan (MEPC 55/2), the 

Republic of Korea (MEPC 55/2/3) and Sweden (MEPC 55/2/4 and MEPC 55/2/5). However, 

due to lack of time, the Group was unable to consider the second submission from Sweden 

(MEPC 55/2/5). 

6.1.2 The Group noted that the format of the non-confidential submissions, their associated 

confidential data and literature references varied considerably. It was agreed that a standard 

approach to submitting data would greatly facilitate the workings of the Group as a considerable 

amount of time can be wasted in searching through the detailed references in order to validate 

data or provide more detailed information. It was recognized that such a standardized approach 

for all toxicological and environmental data was of particular importance. 

6.1.3 As a result, the Group requested that, in addition to a specific complete reference, a 

photocopy of the relevant part of such a reference be included in the supporting data with the 
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relevant information highlighted. This is particularly important where the reference is from a 

large publication which also contains a lot of data irrelevant to the submission. 

6.1.4 The Group also requested that each extracted reference is clearly identified and that the 

file containing them includes a complete index of such references. The Group also requested 

that, where possible, as much data as possible should be provided in electronic format to 

facilitate appropriate searches. 

6.1.5 The Group noted that: 

 .1 Final Approval, as described in G9 and advocated by the United States in 

MEPC 55/2/1 should only concern confirmation that the toxicity of treated ballast 

water at discharge conforms to the evaluation undertaken for the Basic Approval; 

and 

 .2 Basic Approval, as proposed in the definition by the EC in MEPC 55/2/6, is 

restricted to validating risks during prototype or type approval testing. 

6.1.6 As a result, the Group recognized that neither of these two definitions request an 

assessment of risks occurring during full-scale operational application on thousands of ships. 

The Group, therefore, requested advice from MEPC on whether it should consider this situation 

and if so, which assumptions or scenarios for discharge of treated ballast water are relevant and 

should be assessed. Awaiting clarification, the Group decided to develop separate 

recommendations for prototype and type approval testing and where appropriate for full-scale 

deployment. 

6.1.7 In the interim, it was agreed that recommendations for Basic Approval might take the 

form of: 

 .1 a recommendation regarding further development and testing onboard or a strictly 

limited number of ships under controlled conditions or land based systems; or 

 .2 a recommendation, regarding a full-scale deployment on many ships especially 

when the possible effects for humans and the environment have been considered 

as part of the Risk Assessment. 

6.2 General points arising from consideration of the submissions 

6.2.1 The Group agreed that at least one of the applications did not include a complete 

description of the system. In this context, it agreed that the Group should not be requested to 

evaluate conceptual systems that do not include details of how the system would be working in 

practice. Such omissions included the details on the maximum dosage of Active Substance and 

how such maximum dosage and maximum allowable discharge concentration would not be 

exceeded as required by G9 (paragraph 7.1.1). 

6.2.2 As a result, the Group requested MEPC to urge Administrations to check and validate 

potential submissions prior to submitting them to the Group for evaluation as requested in 

paragraph 8 of G9. 

6.3 Detailed review of the submissions

6.3.1 A detailed review of the submissions can be seen in: 
GESAMP-BWWG 2/9 - 12 - 

I:\MEPC\55\2-16.doc 

 .1 Annex 5 Basic Approval of Active Substances used by Special Pipe Ballast 

Water Management System (combined with Ozone treatment) 

submitted by Japan; 

 .2 Annex 6 Basic Approval of Active Substances used by NK Ballast Water 

Treatment System submitted by the Republic of Korea; and 

 .3 Annex 7 Basic Approval of Active Substances used by a Ballast Water 

Management System (EctoSys) submitted by Sweden. 

6.3.2 Rather than reproducing the summaries in this section of the report, Members are 

requested to note that each review contains a summary at the beginning. 

7 CONSIDERATION OF QUERIES FROM MEMBERS AND INDUSTRY 

7.1 The Group was informed about the general questions raised by IUCN during MEPC 54, 

which it addressed in the following paragraphs of this section. 

7.2 The Group recognized the concerns expressed by IUCN that no account was being taken 

of the possible formation of harmful by- and end-products in either ballast water or the marine 

environment. 

7.3 In this context, the Group emphasized the need to consider all possible chemicals and 

mixtures of chemicals produced by proposed systems in order to evaluate the risks associated 

with long-term, high volume, regular discharges into the marine environment. The Group also 

agreed that safety and environmental data associated with such products should also be regarded 

as non-confidential. 

7.4 As a result, the draft methodology was amended to take these points into account and 

MEPC was requested to approve such changes. 

8 FUTURE WORK PROGRAMME AND TENTATIVE DATE FOR THE NEXT 

MEETING 

8.1 The IMO Technical Secretary of GESAMP informed the Group on the difficulties to 

identify suitable mammalian toxicologists and suggested to agree upon a procedure that could be 

used when additional members were needed. Some members of the Group advised about 

potential candidates that could match the required profile, however, the Group agreed that 

ensuring as much as possible a uniform geographical representation is essential. The possibility 

of recruiting ad-hoc experts when highly specialized expertise is required, was also considered by 

the Group particularly for chemical reaction kinetics experts. 

8.2 Based on the experience gained during the first two meetings, the Group agreed to 

develop a set of generic profiles for potential members to assist in the development of a pool of 

experts, accepted by GESAMP, that could be called upon for future meetings. 

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

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

(MSC/Circ.1099, MEPC/Circ.405), the Group agreed that its next session should tentatively be 
 - 13 - GESAMP-BWWG 2/9 

I:\MEPC\55\2-16.doc 

scheduled from 19 to 23 February 2007 to allow sufficient time for evaluation and approval by 

GESAMP and timely submission to MEPC 56. 

8.4 Based on the experience of the first two meetings and taking into account the time needed 

for proper preparation of the next meeting, the Group recommended that MEPC 55 invites 

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

application dossiers by 15 December 2006 as indicated in timetable contained in annex 8 As 

agreed by MEPC 54, non-confidential data related to the proposals for approval of Active 

Substances should be submitted to MEPC 55 or at the earliest opportunity after that, but not later 

than 15 December 2006. 

8.5 Recognizing the possibility that more than three application dossiers may be submitted 

for its review and approval by MEPC 56, the Group expressed its availability to have an 

additional meeting before February 2007 if all necessary conditions are met and the 

non-confidential data related to the respective proposals have been circulated in advance (i.e., at 

MEPC 55) 

9 CONSIDERATION AND ADOPTION OF THE REPORT 

9.1 A draft report of the 2nd meeting of the GESAMP-BWWG was produced on Friday, 

26 May 2006 and after a paragraph-by-paragraph review the Group agreed on the final text and 

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

documents format and style. 

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

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

both in preparation and during the meeting week and closed the meeting at 1500hrs. 

*** 

GESAMP-BWWG 2/9 

I:\MEPC\55\2-16.doc 

ANNEX 1 

LIST OF MEMBERS ATTENDING THE 2ND SESSION 

OF THE GESAMP BALLAST WATER WORKING GROUP 

Mr. Finn Pedersen (Chairman) 

Special Adviser 

Danish Environmental Protection Agency 

Chemicals Unit 

Strandgade 29 E-mail: fpe@mst.dk 

DK-1401 Copenhagen E-mail pedersen_finn@hotmail.com 

Denmark Tel: +45 32 660289 

Ms Teresa Borges 

Senior Technical Officer 

General Health Directorate 

Rua de Arroios 97 

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

Portugal Tel: +351 21 3179767 

Mr. Egil Dragsund 

Principal Marine Biologist 

Environmental and Technical Solutions 

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

Veritasveien1 Tel: +47 67 57 8894 

NO- 1322 Høvik Fax: +47 67 57 9911 

Norway Mobile: +47 97 02 6956 

Mr. Shinichi Hanayama 

Senior Research Fellow 

Maritime Technology Department 

Ocean Policy Research Foundation 

1-15 Toranomon 

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

Tokyo105-0001 Tel: +813 3502 1886 

Japan Fax: +813 3502 2033 

Mr. Jan Linders 

Expert in Environmental Risk assessment 

 of Pesticides and Biocides 

RIVM-SEC 

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

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

Netherlands Fax: +31 30 274 4401 
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Mr. David Tongue 

Marine Manager 

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

12 Carthusian Street Tel: +44 2074718844 

London EC1M 6EZ Fax: +44 2074178877 

United Kingdom Mobile: +44 (0)7855391258 

IMO – GESAMP CONSULTANTS 

Mr. John Crayford 

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

Fleet Tel: +44 1252 6722 49 

Hampshire 

GU51 3AN 

United Kingdom

IMO SECRETARIAT

Mr. Jean-Claude Sainlos 

Director 

Marine Environment Division 

International Maritime Organization 

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

London SE1 7SR Tel: +44 (0)20 7587 3142 

United Kingdom Fax: +44 (0)207 463 4040 

Mr. Dandu Pughiuc 

IMO Technical Secretary to GESAMP-BWWG 

International Maritime Organization 

Marine Environment Division 

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

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

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

Mr. René Coenen 

IMO Technical Secretary to GESAMP 

International Maritime Organization 

Marine Environment Division 

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

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

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

*** 
GESAMP-BWWG 2/9 

I:\MEPC\55\2-16.doc 

ANNEX 2 

PROVISIONAL AGENDA FOR THE SECOND SESSION OF THE 

BALLAST WATER WORKING GROUP OF GESAMP 

1 Introduction 

2 Issues of confidentiality 

3 Outcome of MEPC 54 

4 Terms of reference and time frame 

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

6 Review of proposals for approval of Active Substances 

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

8 Future work programme and tentative date for the next meeting. 

9 Consideration and adoption of the report. 

*** 

GESAMP-BWWG 2/9 

I:\MEPC\55\2-16.doc 

ANNEX 3 

GESAMP-BALLAST WATER WORKING GROUP 

TERMS OF REFERENCE FOR THE TECHNICAL GROUP 

1 Consideration of development of necessary methodologies and information requirements 

in accordance with G9∗ for consideration by MEPC 54. 

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). 

 

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

management systems that make use of Active Substances (G9). 
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4 The Group shall keep confidential all data, the disclosure of which would undermine 

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

*** 
GESAMP-BWWG 2/9 

I:\MEPC\55\2-16.doc 

ANNEX 4 

DEVELOPMENT OF A DRAFT METHODOLOGY FOR INFORMATION 

GATHERING AND THE CONDUCT OF WORK OF GESAMP-BWWG 

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

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

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

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

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

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

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

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

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

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

2.7 Procedures and timelines .............................................................................................8 

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

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

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

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

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

3.1.4 Other Chemicals: ...................................................................................................10 

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

sensitive and representative organisms (G9: 4.2.1.1) ............................................................10 

3.2.1 Acute aquatic toxicity ............................................................................................10 

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

3.2.3 Endocrine disruption..............................................................................................11 

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

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

3.2.6 Food web/population effects..................................................................................12 

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

3.3.1 Acute toxicity.........................................................................................................13

3.3.2 Effects on skin and eye ..........................................................................................13 

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

3.3.4 Chronic toxicity .....................................................................................................14 

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

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

3.3.7 Mutagenicity/genotoxicity .....................................................................................15 

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

3.4.0 Data on environmental fate and effect under aerobic and anaerobic conditions .......16 

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

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

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

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

3.4.5 Potential physical effects on wildlife and benthic habitats....................................18 

3.4.6 Potential residues in seafood..................................................................................18 

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

3.5 Physical and chemical properties for the Active Substances and preparations and 

treated ballast water, if applicable (G9: 4.2.1.4 .....................................................................19 

3.5.1 Melting point..........................................................................................................19
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3.5.2 Boiling point ..........................................................................................................19

3.5.3 Flammability (flash point.......................................................................................19 

3.5.7 Oxidation/reduction potential ................................................................................20 

3.5.9 Autoignition temperature.......................................................................................20 

3.5.10 Explosive properties...............................................................................................20 

3.5.11 Oxidising properties...............................................................................................21 

3.5.12 Surface tension.......................................................................................................21

3.5.13 Viscosity ................................................................................................................21 

3.5.14 Thermal stability and identity of relevant breakdown products ............................21 

3.5.15 Reactivity towards container material ...................................................................21 

3.5.16 pH...........................................................................................................................21 

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

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

3.5.19 Other known relevant physical or chemical hazards .............................................22 

3.6 Analytical methods at environmentally relevant concentrations (G9: 4.2.1.5) .........22 

4 USE OF THE ACTIVE SUBSTANCE OR THE PREPARATION .....................................22 

4.1 The manner of application .........................................................................................22 

5 MATERIAL SAFETY DATA SHEETS (G9: 4.2.7) ............................................................23 

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

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

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

6.1.2 Bioaccumulation (G9: 5.1.1.2) ..............................................................................24 

6.1.3 Toxicity tests (G9: 5.1.2.3) ....................................................................................24 

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

6.2.2 Final approval ........................................................................................................25 

6.2.3 Determination of holding time...............................................................................25 

6.3 Risk characterisation and analysis .............................................................................25 

6.3.1 Reaction with organic matter (see G9: 4.2.1.3; this report 2.4.4)..........................25 

6.3.2 Characterisation of degradation route and rate (G9: 5.3.5) .......................................25 

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

6.3.4 Assessment of potential for bioaccumulation........................................................26 

6.3.5 Effects assessment .................................................................................................26 

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

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

6.3.8 Comparison of effect assessment with discharge toxicity .....................................28 

7 RISK ASSESSMENT............................................................................................................28

7.1 Risk to safety of ship..................................................................................................28 

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

7.3 Risks to the aquatic environment...............................................................................29 

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

9 MODIFICATION TO THE APPLICATION........................................................................30 

10 FINAL APPROVAL..........................................................................................................30 

APPENDIX....................................................................................................................................31 
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1 INTRODUCTION 

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

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

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

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

1.1 Terms and Definitions 

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

Ballast Water Convention to facilitate a consistent evaluation of submissions: 

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

and Management of 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, solvents, auxiliary substances, etc. 

.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 

than the Active Substance(s). 

.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 or human health. 

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

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

Basic Approval shall confirm that the available information does not indicate 

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

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

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

shall be considered when possible. 

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

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

includes a review of the Type Approval tests in accordance with Guidelines for 

Approval of Ballast Water Management Systems. The Final Approval shall 

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

including storage, handling and application of Active Substances or Preparations 

remain valid and the concerns have been addressed, as well as that the residual 
GESAMP-BWWG 2/9 

ANNEX 4 

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toxicity of the discharge conforms to the evaluation undertaken for Basic 

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

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

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

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

dealt with. 

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

reports through GESAMP to MEPC. When considering the comprehensive 

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

relevant information submitted to it. Experts working for GESAMP-BWWG act 

independently in their individual capacity. 

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

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

an advisory and multi-disciplinary body consisting of specialised experts 

nominated by the sponsoring agencies. Experts working for GESAMP act 

independently in their individual capacity. 

1.2 Abbreviations used in the text 

ABBREVIATIONS 

< less than 

< less than or equal to 

> greater than 

> greater than or equal to 

μg microgram 

 

b.p. boiling point 

bw body weight 

BWMS Ballast Water Management System 

 

oC degree Celsius (centigrade) 

CAS chemical abstract service 

cc cubic centimetre 

 

d day(s) 

 

EC50 effect concentration, 50% (median effective concentration) 

 

g gram 

GHS Globally Harmonized System 

G9 Procedure for approval of Ballast Water Management Systems that make

use of Active Substances (G9) Resolution MEPC.126(53) adopted 22 July 

2005 

 

h hour 

 

IARC International Agency for Research on Cancer 
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ABBREVIATIONS 

IC50 inhibition concentration, 50%; 

ISO International Organisation for Standardisation 

IUPAC International Union of Pure and Applied Chemistry 

 

kg kilogram 

Koc organic carbon-water partition coefficient 

 

l litre 

LC50 lethal concentration, 50% 

LD50 lethal dose, 50% 

LOAEL lowest observed adverse effect level 

LDLO lowest lethal dose 

LOEL lowest observed effect level 

 Log P logarithm of the octanol/water partition coefficient 

 

MEPC Marine Environment Protection Committee 

m.p. melting point 

mg milligram 

ml millilitre 

 

ng nanogram 

NOAEL no-observed-adverse-effect level 

NOEL no-observed-effect level 

 

OECD Organisation for Economic Co-operation and Development 

 

Pow octanol-water partition coefficient 

 

TLV threshold limit value 

US EPA United States Environmental Protection Agency 

 

WHO World Health Organization 

 

wt weight 

2 GENERAL 

2.1 Legal provision 

Regulation D-3.2 of the International Convention for the Control and Management of 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). 
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2.2 Principles of acceptability of BWMS that make use of Active Substances 

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

intended purpose through action on Harmful Aquatic Organisms and Pathogens in 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. Ballast Water Management systems that make use of Active Substances and 

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

the Convention. 

2.3 Submission of an application for Basic Approval 

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

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

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

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

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

Organization concerned (G9: 8.1.2.2). 

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

satisfactory and complete before submitting it to IMO. 

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

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

Division, International Maritime Organization, 4 Albert Embankment, London SE1 7SR, 

United Kingdom. 

2.3.4 Application requirements: 

 .1 a complete Application Dossier including all documents identified in 2.3.4 (one 

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

complete Application Dossier should contain a contents list indicating the location 

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

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

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

should follow this format, including its numbering, which is based on G9; 

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

overview of the application (electronic version); 

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

version); 

 .4 the assessment report (electronic version); and 

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

requirements of the G9 procedure (G9: 4.2.5). 
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2.4 Confidentiality and data protection 

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

approval procedure is completed and the Active Substance is approved, the following data 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 content 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 which are 

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

contribute to the hazard documentation of the preparation; 

.5 the 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; 

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

its components and Relevant Chemicals; 

.7 a summary of the results of the tests required pursuant to Section 4.2 of the 

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

and the environment; 

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

to Section 5.2 of the Procedure G9; 

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

storage, transport and fire; 

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

.11 Safety Data Sheets; 

.12 methods of chemical analysis; 

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

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

leakage; 

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

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

Sections 5.1 and 5.3 of Procedure G9; and 
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.17 the uncertainty analysis specified in Chapter 6.4.3 of Procedure G9. 

2.5 Test Methods 

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

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

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

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

be provided. 

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

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

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

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

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

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

submission of all available end-point data for Active Substances and Relevant Chemicals. 

2.5.4 The Administration should supply a list of test substances (for example trade names) 

specified in study reports and literature data and an explanation of how the tested substances 

relates to the current application. 

2.6 Alternatives to testing and non-submission of data 

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

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

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

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

within the applicability domain of the method. 

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

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

supplied. The same applies where it is not scientifically necessary or technically possible to 

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

Group’s evaluation of the Application Dossier. 

2.7 Procedures and timelines 

2.7.1 Procedures for the evaluation of the dossier are given in the Appendix to G9. If, in the 

course of the review by the Ballast Water Working Group, it becomes evident that additional data 

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

are submitted. 

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

Administration may appeal against any decision made by the Organization. The Organization 

will consider the appeal and respond in writing to the Member of the Organization. 

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

BWWG for an hour or so to answer questions regarding the system. 
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3.0 DATA-SET REQUIRED IN THE APPLICATION 

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

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

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

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

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

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

provided as well. 

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

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

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

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

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

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

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

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

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

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

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

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

internationally recognised test method may also be used as well. 

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

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

information: (G9: 4.2.2): 

 .1 the Trade name; 

 .2 compositional information of the Preparation including: 

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

following information: 

 .1 the Trade name (where relevant); 

 .2 the chemical (IUPAC) name; 

 .3 the CAS number; 

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

 .5 the Molar mass; 

 .6 the empirical formula; 

 .7 the structural formula; 

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

and CAS-numbers, etc.); and 

 .9 the identity of any stabilisers or necessary additives. 

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

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

products deemed to be Relevant Chemicals: 

 .1 the Chemical (IUPAC) name; 

 .2 the CAS number; 

 .3 the Molar mass; 

 .4 the empirical formula; and 

 .5 the structural formula. 

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

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

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

sensitive and representative organisms (G9: 4.2.1.1) 

3.2.0 For every Active Substance or preparation including any of its components, data should 

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

knowledge for each end point listed. 

3.2.1 Acute aquatic toxicity 

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

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

(Algae, Growth Inhibition Test), 202 (Daphnia sp. Acute Immobilization Test), 203 (Fish, Acute 
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Toxicity Test), Mysid shrimp acute toxicity test (USEPA 850.1035)) should be accepted. To 

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

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

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

estimating the acute toxicity of substances and discharge provide acceptable alternatives 

3.2.1.3 Such acute aquatic toxicity data are required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; 

 .3 Relevant Chemicals; and 

 .4 Treated ballast water (G9: 5.2.3) 

3.2.2 Chronic aquatic toxicity 

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

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

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

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

(e.g., echinoderms, molluscs). 

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

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

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

testing. 

3.2.2.3 Such chronic aquatic toxicity data are required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; 

 .3 Relevant Chemicals; and 

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

3.2.3 Endocrine disruption 

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

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

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

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

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

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

tests may be waived. 

3.2.3.2 Such information on endocrine disruption is required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 
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3.2.4 Sediment toxicity 

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

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

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

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

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

of two tests with marine species. 

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

specific marine sediment assessment is necessary. 

3.2.4.3 Such information on sediment toxicity is required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; 

 .3 Relevant Chemicals; and 

 .4 Treated Ballast water. 

3.2.5 Bioavailability/biomagnification/bioconcentration 

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

account the following points: 

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

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

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

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

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

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

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

bioaccumulation and biodegradation data; and 

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

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

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

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

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

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

 .1 Active Substances; 

 .2 Any components of a preparation; and 

 .3 Relevant Chemicals. 

3.2.6 Food web/population effects 

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

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

biodegradation data. 
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3.2.6.2 An assessment of secondary poisoning is redundant if for the substance of concern 

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

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

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

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

Section 2.3 below). 

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

 .1 Active substances; and 

 .2 Relevant Chemicals. 

3.3.0 Data on mammalian toxicity (G9: 4.2.1.2) 

3.3.0.1 Information which is not necessary need not be supplied. In such cases a justification 

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

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

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

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

human experience or epidemiological evidence should be presented and discussed. 

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

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

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

3.3.1 Acute toxicity 

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

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

inhalation. 

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

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

proposed or potential application of the substance/products. 

3.3.1.3 Such information on acute toxicity is required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals 

3.3.2 Effects on skin and eye 

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

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

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

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

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

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

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

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

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

properties, or is a severe skin irritant, an eye irritation test shall not be carried out. Results from 

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

submitted. 

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

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

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

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

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

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

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

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals 

3.3.3 Repeated-dose toxicity 

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

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

3.3.3.2 Such information on repeated dose toxicity is required for: 

 .1 Preparation including any of its components; 

 .2 Active Substance; and 

 .3 Relevant Chemicals 

3.3.4 Chronic toxicity 

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

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

necessary. 

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

3.3.4.3 Such information on chronic toxicity is required for: 

 .1 Preparation including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 
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3.3.5 Developmental and reproductive toxicity 

3.3.5.1 Testing should include: 

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

Two-Generation Reproduction Toxicity Study); and 

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

(OECD guideline 414 – Prenatal Developmental Toxicity Study). 

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

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

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

disruption and anticipated use and human exposure patterns. 

Such information on developmental and reproductive toxicity is required for: 

 .1 Preparation including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.3.6 Carcinogenicity 

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

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

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

be combined with the chronic toxicity studies. 

3.3.6.2 Such information on carcinogenicity is required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances and 

 .3 Relevant Chemicals. 

3.3.7 Mutagenicity/genotoxicity 

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

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

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

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

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

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

3.3.7.2 Such information on mutagenicity and genotoxicity is required for: 

 .1 Preparations including any of its components; and 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 
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3.3.8 Toxicokinetics 

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

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

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

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

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

the need for any specific dermal toxicity testing. 

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

(G9: 4.2.1.3) 

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

preparation and Relevant Chemicals under aerobic and anaerobic conditions should be assessed, 

resulting in the identification of relevant metabolites in the relevant media (ballast water, marine 

and fresh waters) (G9: 5.3.4). 

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

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

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

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

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

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

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

3.4.1 Modes of degradation (biotic; abiotic) 

3.4.1.1 Testing should include: 

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

OECD guideline 111; 

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

Biodegradability) or equivalent guidelines if the Active Substance is discharged 

only into fresh water; 

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

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

discharged only into marine water; and 

 .4 studies on ready biodegradability according to OECD guideline 301 (or equivalent 

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

Substance is discharged into estuarine water (e.g., inland harbour with contact to 

seawater). 

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

should be conducted: 

 .1 a study on aerobic and anaerobic transformation in aquatic sediment systems 

according to OECD guideline 308 (Aerobic and Anaerobic Transformation in 
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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 phototransformation in 

water (1997) 

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

 .1 Active Substances; 

 .2 any other components of preparations; and 

 .3 Relevant Chemicals 

3.4.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient 

3.4.2.1 Testing should include: 

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

earlier in this document; 

 .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 (OECD 123 (Partition 

coefficient - slow stirring method) is required: 

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

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

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

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

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

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

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

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

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

 .1 Active Substances 

 .2 any other components of preparations; and 

 .3 Relevant Chemicals. 

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

and fresh waters). 
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3.4.3.1 The route of degradation in the higher tier simulation tests specified under section 3.4.1 of 

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

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

considered as Relevant Chemicals should be identified. 

3.4.3.2 Such information on persistence and metabolites is required for: 

 .1 Active Substances; 

 .2 any components of preparations; and 

 .3 Relevant Chemicals. 

3.4.4 Reaction with organic matter 

3.4.4.1 The reaction of radicals produced by the action of Active Substances1 with organic matter 

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

possible, quantitatively as to identify environmental concentrations. 

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

brominated) hydrocarbons which may be of concern to environmental or human health, in the 

presence of organic matter. For these substances, the freely and otherwise reasonably available 

information should be presented and discussed in relation to the proposed manner of application, 

since they are subject to the decision making criteria. 

3.4.4.3 Such information on the reaction with organic matter is required for: 

 .1 Active Substances; and 

 .2 Relevant Chemicals. 

3.4.5 Potential physical effects on wildlife and benthic habitats 

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

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

GESAMP Reports and Studies No. 64. 

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

for: 

 .1 Preparations including any of its components 

 .2 Active Substance; 

 .3 Relevant Chemicals; and 

 .3 Treated Ballast water 

3.4.6 Potential residues in seafood 

3.4.6.1 As appropriate, data shall be submitted to assess the risk that residues of the Active 

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

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

seafood shall be submitted. 

 

1

 MEPC 55/2/6 para 33 
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3.4.6.2 Such data on potential residues in seafood are required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.4.7 Any known interactive effects 

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

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

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

be reported. 

3.4.7.2 Such information on known interactive effects is required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.5 Physical and chemical properties for the Active Substances and preparations and 

treated ballast water, if applicable (G9: 4.2.1.4) 

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

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

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

3.5.1 Melting point 

Data on the melting point are required for: 

 .1 Preparations including any of its components; and 

 .2 Active substances. 

3.5.2 Boiling point 

Data on the boiling point are required for: 

 .1 Preparations including any of its components; and 

 .2 Active Substances. 

3.5.3 Flammability (flash point) 

Data on the flash point are required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals 

3.5.4 Density (relative density) 
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Data on the density are required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Treated Ballast water. 

3.5.5 Vapour pressure, vapour density 

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

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.5.6 Water solubility/dissociation constant 

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

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.5.7 Oxidation/reduction potential 

Data on the oxidation/reduction potentials are required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; 

 .3 Relevant Chemicals; and 

 .4 Treated Ballast water. 

3.5.8 Corrosivity to the materials or equipment of normal ship construction 

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

 .1 Preparations including any of its components; 

 .2 Active Substances; 

 .3 Relevant Chemicals; and 

 .4 Treated Ballast water. 

3.5.9 Autoignition temperature 

Data on the autoignition temperature are required for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.5.10 Explosive properties 

Data on the explosive properties are required for: 
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 .1 Preparations;2

 .2 Active Substance; and 

 .3 Relevant Chemicals. 

3.5.11 Oxidizing properties 

Data on the oxidizing properties are required for: 

 .1 Preparations; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.5.12 Surface tension 

Data on the surface tension are required for: 

 .1 Preparations; and 

 .2 Active Substance. 

3.5.13 Viscosity 

Data on the viscosity are required for: 

 .1 Preparations; and 

 .2 Active Substances. 

3.5.14 Thermal stability and identity of relevant breakdown products 

Data on the melting point are required for: 

 .1 Preparations including any of its components; and 

 .2 Active Substances. 

3.5.15 Reactivity towards container material 

Data on the reactivity towards container materials are required for: 

 .1 Preparations including any of its components; 

 .2 Active substances; 

 .3 Relevant Chemicals; and 

 .4 Treated ballast water. 

3.5.16 pH 

Data on the pH are required for: 

 .1 Preparations; and 

 .2 Treated Ballast water. 

 

2

 MEPC 55/2/6, para 34. 
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3.5.17 Salinity 

Data on the salinity are required for: 

 .1 Treated Ballast water. 

3.5.18 TOC, DOC, % particulate matter 

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

 .1 Treated Ballast water. 

3.5.19 Other known relevant physical or chemical hazards 

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

 .1 Preparations including any of its components; 

 .2 Active Substances; 

 .3 Relevant Chemicals; and 

 .4 Treated Ballast water 

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

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

methods at environmentally relevant concentrations are required for 

 .1 Preparations including any of its components; 

 .2 Active Substance; 

 .3 Relevant Chemicals. 

4 USE OF THE ACTIVE SUBSTANCE OR THE PREPARATION 

4.1 The manner of application 

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

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

time (G9: 4.2.6). 

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

addressing the following items: 

 .1 the technical manual or instructions by the Administration, including the product 

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

components and materials used, technical installation specifications, system 

limitations, and routine maintenance should be provided (BWWG), including 

quantity to be added to ballast water and maximum concentration of the Active 

Substance therein; 
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 .2 recommended methods and precautions concerning handling, use, storage, and 

transport; 

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

combustion gases, etc.; 

 .4 Emergency measures in case of an accident; 

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

in the marine environment; 

 .6 procedures of waste management of the Active Substance; 

 .7 the possibility of reuse or recycling; 

 .8 the possibility of neutralization; 

 .9 conditions for controlled discharge; and 

 .10 the amount of substance onboard ship 

4.1.3 Appropriate risk management measures (e.g., for neutralization of the Active Substance 

in case of emergency or if PEC/PNEC at discharge >1) should be described. These management 

measures are an integral part of the Ballast Water Management System and should be evaluated 

in the assessment. 

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

ship, personnel and the environment. 

5 MATERIAL SAFETY DATA SHEETS (G9: 4.2.7) 

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

been prepared for the United Nations Globally Harmonized System of Classification and 

Labelling of Chemicals (GHS) to aid in interpreting data for classifying substances as dangerous. 

Reference is also made to the MEPC approved hazard evaluation procedure published as 

GESAMP Reports and Studies No. 64 under the title The Revised GESAMP Hazard Evaluation 

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

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

detailed guidance on hazard identification. 

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

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

hazardous under GHS, this should also be clearly stated. 

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

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

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

the Key Data Summary Table. 
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6 RISK CHARACTERIZATION 

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

6.1.1 Persistence (G9: 5.1.1.1) 

6.1.1.1 Persistence is preferably assessed in simulation test systems to determine the half-life 

under relevant conditions. Biodegradation screening tests may be used to show that the 

substances are readily biodegradable. The determination of the half-life should include 

assessment of Relevant Chemicals. 

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

6.1.2 Bioaccumulation (G9: 5.1.1.2) 

6.1.2.1 The assessment of the bioaccumulation potential should use measured bioconcentration 

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

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

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

6.1.3 Toxicity tests (G9: 5.1.2.3) 

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

used for the assessment of the toxicity criterion. 

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

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

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

assessment. 

6.1.4 Does the Active Substance and/or preparation meet all three criteria for PBT? 

See G9: Table 1 

Criterion PBT criteria 

Persistence Half-life: 

> 60 days in marine water, or 

> 40 days in freshwater,* or 

> 180 days in marine sediment, or 

> 120 days in freshwater sedimenta 

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

experimentally BCF has been determined, Log Pow≥3 

Toxicity Chronic NOEC < 0.01 mg/l 

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

freshwater sediment can be overruled by data obtained under marine conditions. 

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

approval in accordance with paragraph 6.4.1 of the Procedure. 
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6.2 Evaluation of the treated ballast water (G9: 5.2) 

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

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

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

6.2.1 Basic approval 

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

BWMS (G9: 5.2.1) 

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 Laboratory toxicity tests with samples of ballast water treated with the BWMS during 

on-board testing should be conducted (G9: 5.2.2). 

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

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

must be approved by the Organization. 

6.2.3 Determination of holding time 

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

discharge, i.e., the necessary dilution of the treated ballast water. The half-life, decay and dosage 

rates, system parameters and toxicity should be used to determine the amount of time needed to 

hold the treated ballast water before discharge (5.2.7). An indication of the uncertainty of the 

holding time should be given, taking into account variables (e.g., temperature, pH, salinity and 

sediment loading). 

6.3 Risk characterization and analysis 

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

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

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

Chemicals that may be of concern to the environment. 

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

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

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

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

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

rates under specified conditions (e.g., pH, redox, temperature). 
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6.3.3 Prediction of discharge and environmental concentrations 

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

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

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

6.3.3.2 Environmental concentrations after discharge of treated ballast water under controlled 

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

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

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

components of Preparations, as appropriate, should be estimated. 

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). 
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6.3.6 Effects on aquatic organisms 

6.3.6.1 For assessment of effects to the aquatic environment, appropriate Predicted No-EffectConcentrations (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 caseby-case basis based on expert judgement. In cases where a comprehensive 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 (PNECsaltwater) is needed, this may be derived by applying a higher 

assessment factor than for the derivation of a PNECfreshwater to reflect the greater uncertainty in 

protecting sensitive species in saltwater environments. Where data are available for additional 

taxonomic groups, for example rotifers, echinoderms or molluscs, the uncertainties in the 

extrapolation are reduced and the magnitude of the assessment factor applied to a dataset can be 

lowered. 

6.3.6.4 For naturally occurring Active Substances not meeting PBT-Criteria and being rapidly 

degradable, the PNEC could be set along the background concentration in the environmental 

compartment under consideration. 

Table 2 Effect assessment for deriving PNECs for freshwater and saltwater 

 Assessment Factor 

Data set PNEClong PNECshort 

Freshwater assessment 

Lowest short-term L(E)C50 from fresh water 

species representing three trophic levels 

1000 10-100 

Lowest chronic NOEC from three freshwater or 

saltwater species representing three trophic levels 

10 

Saltwater assessment 

Lowest short-term L(E)C50 from marine species 

representing three trophic levels 

1000 10-100 

Lowest chronic NOEC from three freshwater or 

saltwater species representing three trophic levels 

100 

Lowest chronic NOEC from three saltwater species 

representing three trophic level 

100 

Lowest chronic NOEC from three freshwater or 

saltwater species representing three trophic levels + 

at least two chronic NOECs from additional marine 

taxonomic groups 

10 
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6.3.7 Effects on sediment 

6.3.7.1 Because sediment constitutes an important compartment of ecosystems, it may be 

important to perform an effects assessment for the sediment compartment for those substances 

that are likely to transfer substantially into the sediment. Most of the existing whole sediment 

tests measure acute toxicity and only a few measure long-term, sub-lethal endpoints. Only the 

latter tests are considered applicable to risk assessment because of the long-term exposure of 

benthic organisms to sediment-bound substances that occur under field conditions. Due to the 

generally long-term exposure of benthic organisms to sediment-bound substances, long-term 

tests with sub-lethal endpoints like reproduction, growth, emergence, sediment avoidance and 

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; 
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 .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) 

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 Administration of the Ballast Water Management System. 

Health effects in humans 

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

should include a screening on carcinogenic, mutagenic and endocrine disruptive properties. If 

the screening results give rise to concerns, this should give rise to a further effect assessment 

(G9: 5.3.12). 

7.3 Risks to the aquatic environment 

7.3.1 The potential risks to the aquatic environment during experimental development and type 

approval testing should be assessed. 

7.3.2 When no aquatic toxicity of the treated ballast water at discharge is found either through 

direct testing of the treated ballast water or if the estimates ratios between predicted 

concentrations of the Active Substance, components of preparations or Relevant Chemicals, as 

appropriate, and the respective PNEC values are below 1, no further assessment of direct toxic 

effects to the aquatic environment is necessary. 

7.3.3 In other cases, the dilution necessary to ensure that the PNEC values are not exceeded 

should be calculated by an appropriate model for relevant controlled use and discharge scenarios. 

7.3.4 The potential risks to the aquatic environment resulting from full-scale deployment 

onboard ships and discharge of treated ballast water under representative conditions should be 

assessed. The specific assessment might await further development of an appropriate Emission 

Scenario Document for discharge of treated ballast water. 
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8 ASSESSMENT REPORT (G9: 4.3) 

The Assessment report referred to in point 4.3 of the Procedure shall at least provide: 

 .1 an overview of the data and endpoints on which the risk characterization 

according to section 6 of the Procedure is based including a description of the 

quality of test reports; 

 .2 an assessment of risks to the safety of ships, crew (human health), the 

environment and resources (e.g., fisheries) during development and type approval 

testing as well as during full-scale deployment onboard ships in accordance with 

section 6 of the Procedure; 

 .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 which 

were determined experimentally, along with an identification or description of the 

modelling methodology; 

 .5 an evaluation of the association between the Ballast Water Management System 

making use of Active Substances or preparations containing one or more Active 

Substances to comply with the Convention in question, the related adverse effects 

and the environmental concentrations, either observed or expected based on the 

risk assessment and the effluent testing; 

 .6 a qualitative statement of the level of uncertainty in the evaluation referred to 

under the preceding paragraph; and 

 .7 a detailed description of risk management possibilities, e.g., for neutralization of 

the Active Substance in case of emergency or if PEC/PNEC at discharge >1. 

These management measures are an integral part of the Ballast Water 

Management System. 

9 MODIFICATION TO THE APPLICATION 

9.1 Administrations should report any modifications in names, including trade and technical 

name, composition or use of the Active Substances and Preparations in the Ballast Water 

Management systems approved by the Organization, to the Member of the Organization. The 

Member of the Organization should inform the Organization accordingly (G9: 8.4.1). 

9.2 Administrations intending to significantly change any part of a Ballast Water 

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

Preparations used in it should submit a new application (G9: 8.4.2). 

10 FINAL APPROVAL 

Further guidance on methodology and testing and sampling for final approval to be added. 
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APPENDIX 

Key Data Summary Form for the ‘Procedure for approval of BWM systems that Make Use 

of Active Substances (G9)’ 

The proposal for approval should include information on the data set either for the preparation, or 

for each component separately (G9: 4.2.2), or for the ballast water itself in the case of in situ

generated systems. 

Section 1: Identification (G9 4.1) 

Trade name of preparation: 

Composition of preparation, including identification of active ingredient(s): 

Ingredient (IUPAC name) Identification Numbers 

(e.g., CAS number) 

Percentage (indicating 

units, e.g., w/w, g/l) 

Active Substance 

1. Other component 

2. Other component 

3. Other component, etc. 

Identification of any Relevant Chemicals (IUPAC name, CAS number): 

Section 2: Effects on aquatic organisms (G9: 4.2.1.1) 

Acute aquatic toxicity 

Test substance Species (e.g., 

fish, Daphnia, 

algae) 

Effect 

(L(E)C50, 

duration ; 

NOEC) 

Value (units); 

range 

Reference/ 

comments 

Preparation 

Active Substance 

Other 

components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant 

Chemicals 

 

Ballast water 

Other 

Data waivers for acute aquatic toxicity 

Species Test substance Test Reason for not supplying 

the data 

 
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Chronic aquatic toxicity 

Test substance Species (e.g., 

fish, Daphnia, 

algae) 

Effect (NOEC; 

duration) 

Value 

(units); 

range 

Reference/ 

comments 

Preparation 

Active Substance 

Other 

components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant 

Chemicals 

 

Ballast water 

Other 

Data waivers for chronic aquatic toxicity 

Species Test substance Test Reason for not supplying 

the data 

 

Information on endocrine disruption 

Substance Information on endocrine disruption 

Preparation 

Active Substance 

Other components 

(1, 2, 3) 

Relevant Chemicals 

Other 

Sediment toxicity 

Test substance Species Effect 

L(E)C50; 

duration; 

NOEC 

Value 

(units); 

range 

Reference/ 

comments 

Preparation 

Active 

Substance 

 

Other 

components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant 

Chemicals 

 

Ballast water 

Other 
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Data waivers for sediment toxicity 

Test substance Species Test Reason for not supplying 

the data 

 

Bioavailability/biomagnification/bioconcentration 

Substance Log 

Pow 

BCF Cause 

for 

concern 

(yes/no) 

Reference/Comments 

Active Substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant 

Chemicals 

 

Other 

Food web/population effects 

Substance Cause for 

concern 

(yes/no) 

Comments 

Active Substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

Relevant 

Chemicals 

 

Other 

Section 3: Data on mammalian toxicity (G9 4.2.1.2) 

Acute Toxicity 

Substance Species Method 

guidelines 

Route; dose 

levels; 

duration of 

exposure 

Endpoint 

Oral LD50; 

Dermal 

LD50; 

Inhalation 

LC50 

Value 

(units) 

Reference/ 

Comments 

Preparation 

Active 

Substance 

 

Other 

components 

1. 

2. 

 
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(1, 2, 3) 3. 

Relevant 

Chemicals 

 

Other 

Skin Irritation 

Substance Species Method 

guidelines 

Average 

score (24, 

48, 72 h) 

Reversability 

(yes/no) 

Result Reference/ 

Comments 

Preparation 

Active 

Substance 

 

Other 

components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant 

Chemicals 

 

Other 

Eye Irritation 

Substance Species Method 

guidelines 

Average 

score (24, 

48, 72 h) 

Reversability 

(yes/no) 

Result Reference/ 

Comments 

Preparation 

Active 

Substance 

 

Other 

components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant 

Chemicals 

 

Other 

Skin sensitization 

Substance Species Method 

guidelines 

(Buehler, 

M&K) 

Sensitiser 

(y/n) 

Reference/Comments 

Preparation 

Active Substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant Chemicals 

Other 
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Repeated-dose toxicity 

Substance Species Method 

guidelines 

Route; 

Duration 

of study; 

dose levels 

and 

frequency 

of 

application

Results NOAEL; 

NOEL 

(units); 

range 

Reference/ 

Comments

Preparation 

Active Substance 

Other 

components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant 

Chemicals 

 

Other 

Data waivers for repeated-dose toxicity 

Test substance Test; species; 

route of exposure 

Reason for not supplying the data 

 

Developmental and reproductive toxicity 

Substance Species Method 

guidelines 

Route; 

Duration

; doses 

Effects; NOAEL 

maternal 

toxicity; NOAEL 

embryotoxicity; 

NOAEL 

parental; 

NOAEL F1; 

NOAEL F2 

(units); range 

Reference/ 

Comments 

Preparation 

Active Substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant 

Chemicals 

 

Other 
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Data waivers for developmental and reproductive toxicity 

Test substance Test; species; 

route of exposure 

Reason for not supplying the data 

 

Carcinogenicity 

Substance Species Method 

guidelines 

Route; 

Duration; 

doses; 

frequency of 

application 

Effects; 

NOAEL; 

NOEL 

(units) 

Reference/ 

Comments 

Preparation 

Active Substance 

Other 

components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant 

Chemicals 

 

Other 

Data waivers for carcinogenicity 

Test substance Test; species; 

route of exposure 

Reason for not supplying the data 

 

Mutagenicity/genotoxicity 

Substance Species 

(In vitro or 

in vivo) 

Method 

guidelines 

With/with

out 

activation; 

duration; 

concentrat

ions tested 

Results 

(positive/ 

negative) 

Reference/Co

mments 

Preparation 

Active Substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant 

Chemicals 

 

Other 
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Data waivers for mutagenicity/genotoxicity 

Test substance Test; Species; 

route of exposure 

Reason for not supplying the data 

 

Section 4: Data on environmental fate and effect under aerobic and anaerobic 

conditions (G9: 4.2.1.3) 

Modes of degradation (biotic; abiotic) 

Hydrolysis at pH 5, 7, 9 

Test substance Test; 

duration 

pH; 

temp 

Value (units); half 

life 

Reference/ 

comments 

Active Substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant Chemicals 

Other 

Data waivers for hydrolysis 

Test substance Test Reason for not supplying the data 

 

Biodegradability 

Test substance Test type; 

duration; 

sea-

/freshwater 

Readily 

biodegradable 

(y/n) 

Value 

(units); half 

life 

Identification 

of breakdown 

products 

Reference/ 

comments 

Active Substance 

Other 

components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant 

Chemicals 

 

Other 
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Data waivers for biodegradation 

Test substance Test Reason for not supplying the data 

 

Partition coefficients 

Test 

substance 

Coefficient 

(Pow; 

Koc; 

other) 

Test 

method; 

pH; temp 

Value (log 

units) 

Reference/ 

comments 

Active 

Substance 

 

Other 

components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant 

Chemicals 

 

Other 

Data waivers for partition coefficients 

Test substance Test Reason for not supplying the data 

 

Persistence and identification of the main metabolites 

Test substance Test; 

duration 

pH; 

temp 

Value (units); half 

life 

Reference/ 

comments 

Active Substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant Chemicals 

Other 

Data waivers for persistence and identification of the main metabolites 

Test substance Test Reason for not supplying the data 

 
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Reaction with organic matter 

Test substance Discussion of the reaction, including 

formation of hazardous byproducts 

Reference/ 

comments 

Active Substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

Relevant Chemicals 

Other 

Potential physical effects on wildlife and benthic habitats 

Test substance Physical 

description 

(state, 

solubility, 

viscosity) 

Discussion of potential effects Reference/ 

comments 

Preparation 

Active Substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant Chemicals 

Ballast water 

Other 

Potential residues in seafood 

Test substance Monitoring 

data/residues 

Impact on consumer safety Reference/ 

comments 

Preparation 

Active Substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant Chemicals 

Other 

Any known interactive effects 

Test substance Interaction with 

other chemicals, 

BWS, or receiving 

environment 

Discussion of potential 

effects 

Reference/ 

comments 

Active Substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant Chemicals 

Ballast water 

Other 
GESAMP-BWWG 2/9 

ANNEX 4 

Page 40 

I:\MEPC\55\2-16.doc 

Physical and chemical properties for the Active Substances and preparations and treated 

ballast water, if applicable (G9: 4.2.1.5) 

Property (with units 

and reference) 

Preparation Active 

Substance 

Other 

components (1, 

2, 3) 

Relevant 

Chemicals 

Ballast water 

Melting point (°C) 1. 

2. 

3. 

Boiling point (°C) 1. 

2. 

3. 

Flammability (flash 

point for liquids; °C) 

 1. 

2. 

3. 

Density (20 °C; kg/m3) 

Vapour pressure (20 °C; 

Pa) 

 1. 

2. 

3. 

Vapour density (air = 1) 1. 

2. 

3. 

Water solubility (temp; 

effect of pH; mg/l) 

 1. 

2. 

3. 

1. 

2. 

3. 

pH in solution 

Dissociation constant 

(pKa) 

 1. 

2. 

3. 

1. 

2. 

3. 

Oxidation-reduction 

potential 

 

Corrosivity to material 

or equipment 

 1. 

2. 

3. 

1. 

2. 

3. 

Reactivity to container 

material 

 

Autoignition 

temperature (°C) 

 

Explosive properties 

Oxidising properties 

Surface tension 

Viscosity 1. 

2. 

3. 

Thermal stability and 

identity of breakdown 

products 

 

Other physical or 

chemical properties 

 1. 

2. 

3. 

1. 

2. 

3. 

Shaded cells, data not required 

Salinity, TOC, DOC, and % particulate matter are required for the ballast water used in type 

approval testing. 
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Analytical methods at environmentally relevant concentrations (G9: 4.2.1.5) 

Substance Analytical method; 

conditions; applicability 

(water/sediment) 

Sensitivity Reference/ 

comments 

Preparation 

Active Substance 

Relevant 

Chemicals 

 

Other 

Use of the preparation 

Brief description of the handling storage and use: 

Material safety data sheets 

Substance Provided 

(yes/no) 

Classification according to 

GHS 

Reference/ 

comments 

Preparation 

Active Substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Other 

Risk characterization 

Substance Persistent (y/n) Bioacumulative 

(y/n) 

Toxic (y/n) Reference/ 

comments 

Preparation 

Active Substance 

Other components 

(1, 2, 3) 

1. 

2. 

3. 

 

Relevant 

Chemicals 

 

Other 

Evaluation of the treated ballast water 

Conclusion of the half-life of the toxicity of the treated ballast water, and the recommended 

holding time. 

Risk characterization 

Conclusion on the effects of reaction with organic matter 

Conclusion of persistence 

Conclusion on the discharge concentration 

*** 

GESAMP-BWWG 2/9 

I:\MEPC\55\2-16.doc 

ANNEX 5 

REVIEW OF PROPOSAL FOR APPROVAL OF ACTIVE SUBSTANCE 

Ozone - submitted by Japan 

0 SUMMARY 

0.1 The Group noted that the Active Substance (ozone) is generated on demand and so there 

will not be any safety hazards associated with the storage of the chemical onboard. However, as 

ozone is very toxic by inhalation and may also have long-term health effects, appropriate 

measures must be taken to ensure that there is no hazardous human exposure to this chemical. 

0.2 The Group noted that two by-products of the system (hypobromous acid ion and 

hypobromous acid were generated in such small amounts as not to be regarded as Relevant 

Chemicals but that bromate ion should be. However, the Group also considered that bromoform 

might be generated in sufficient quantities to produce a potential risk and that this should be 

investigated further. 

0.3 The Group noted that bromate ion has a high potential for mutagenicity and 

carcinogenicity and, therefore, human exposure should be avoided completely. This is 

particularly important if the crew has to enter a ballast water tank after treatment. 

0.4 The Group agreed that neither Ozone nor bromate ion exhibited PBT potential but 

bromoform needs to be considered in detail, if considered to be a Relevant Chemical, once the 

data are made available. 

0.5 The Group agreed that Ozone does not pose any environmental risk due to its very short 

half-life. However the Total Residual Oxidant (TRO) by-products, which include bromate ions, 

are a cause for concern along with bromoform. 

0.6 As the Group had major reservations about the estimation of the Predicted Environmental 

Concentration (PEC), it was concluded that the TRO should not present an unacceptable risk to 

the environment during further prototype development and testing provided that sufficient 

dilution of discharged ballast water is secured. Nevertheless, this aspect should be considered in 

greater detail once a standard environmental scenario has been agreed by MEPC which can be 

run by suitable models. 

0.7 However, the Group did not agree with the applicant that bromoform should not be 

regarded as a Relevant Chemical and so proposed that further information on the generated 

amounts and the physical and biological properties is provided along with the associated 

predicted environmental fate so that a proper Risk Assessment can be carried out on this 

by-product of the system. 
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ANNEX 5 

Page 2 

I:\MEPC\55\2-16.doc 

0.8 Whilst recognizing that the application contained much of the information required by the 

Group to carry out an evaluation of the potential hazards and a subsequent Risk Assessment 

associated with the proposed system, the Group had a number of concerns, inter alia: 

 .1 more information is required regarding the formation of bromoform and its 

associated risks; 

 .2 more information is required regarding the effects of discharges during onboard 

testing and development; 

 .3 more information is required regarding the potential environmental effects should 

Final Approval be granted which would allow the system to become operational 

on a large scale, i.e., installed on many ships; 

0.9 The Group recommended that Basic Approval be granted to the system described in the 

Japanese submission (MEPC 55/2) for further prototype testing and development, based on the 

Guidelines developed by the Organization. The various concerns raised should be addressed to 

the satisfaction of the Group and MEPC. This recommendation does not prejudice the results of 

an eventual risk assessment of a full-scale operational application to be considered for Final 

Approval. Therefore, the Group stressed that, at this stage, it was not possible to judge whether 

the system would be suitable for recommending Final Approval. 

1 INTRODUCTION 

1.1 Data used to evaluate this product were, primarily, extracted from MEPC 55/2 and 

supplemented with additional information provided by the applicant or identified by the Group 

from other sources. 

1.2 Whilst the applicant had provided a considerable amount of additional reference data, 

these were incorporated in large extracts of information which was not relevant to the 

submission. The Group agreed that this made identification of the relevant data for validation 

difficult and time-consuming. 

2 COMPLETENESS OF DOSSIER 

2.1 The Group noted that full information about the quality control/quality assurance 

programme implemented in the testing process of the Ballast Water Management System was not 

provided in the dossier. In addition, it was noted that, whilst the testing of the treated ballast 

water had been done to GLP standards, other data provided were taken from the literature where 

the quality of the data could not be determined. 

2.2 It was noted that MEPC 55/2 states that the reaction between Ozone and bromate ion in 

the seawater produces hypobromous acid ion, hypobromous acid and bromate ion and the ratio of 

such reaction products varies with pH. It was also noted that MEPC 55/2 states further that only 

the bromate ion is generated in the pH range of 5 to 8 which is the assumed range of ballast 

water. 
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ANNEX 5 

Page 3 

I:\MEPC\55\2-16.doc 

2.3 As a result, no data were provided for hypobromous acid ion or hypobromous acid. The 

Group considered that it might have been useful to see quantitative data to support this claim. 

2.4 It was further noted that the dossier did not include information about other chemicals 

such as bromoform that may be relevant according to open available literature (see section 3.3). 

The Group therefore recommended that relevant sampling and analysis is included in the further 

testing onboard ships and in landbased tests and that these data are submitted in the application 

for final approval. 

3 DESCRIPTION OF BWMS 

3.1 BWMS components 

3.1.1 The submission informs that the ballast water treatment and disinfecting system 

comprises of four main sections as follows: 

 .1 the first being a pre-treatment filtration unit, 

 .2 the second contains a mechanical treatment element and a chemical treatment 

element where ozone generated on board is injected into the ballast water; 

 .3 the third is a gas/liquid separation unit where undissolved ozone is removed and 

then destroyed; and 

 .4 the fourth and final section is a post-treatment unit designed to control the 

concentration of oxidants remaining in the ballast water 

3.1.2 It was noted that the system is designed to store the treated ballast water in the ballast 

tank for at least 48 hours before it is discharged. It was also noted that the applicant had stated 

that with post treatment, even a storage time of less than 48 hours will reduce the concentration 

to an acceptable level. 

3.1.3 It was noted that the applicant had indicated that the treatment system is fully automated 

with the controls intended to be integrated in the ships ballasting consol. The in-line main 

treatment unit is to be located in the ships ballast main after the main ballast pump and the 

disinfection treatment will be applied during uptake of ballast water. 

3.2 Application 

3.2.1 Ozone will be generated on demand and will be injected into the ballast water to a 

maximum level of 4 mg Ozone/litre ballast water. It is recommended that the treated water 

remain in the ballast tank for at least 48h to ensure the decay of Relevant Chemicals to a level 

acceptable to the receiving environment. The system includes a ballast water discharge 

conditioning unit to treat oxidants remaining in the ballast water at discharge. 

3.2.2 It was noted that there is no need to store ozone on board ship and the submission 

identifies the intended safety measures to be put in place that will reduce the risk of crew 

exposure to ozone. 
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ANNEX 5 

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I:\MEPC\55\2-16.doc 

3.3 Active Substance(s) 

3.3.1 The manufacturer indicates that: 

 .1 ozone is the Active Substance employed in this system; and 

 .2 bromate ions, which are generated to a level of 3.3mg TRO/litre ballast water 

following treatment with ozone at 4mg/l, should be considered as Relevant 

Chemicals. 

3.3.2 It was noted that, in a similar system employing ozone as the Active Substance, the 

applicant indicated that bromoform should be considered as a Relevant Chemical. When this 

point was queried, the applicant informed the Group that bromoform would only be produced in 

any significant quantities at pH values lower than found in seawater. However, it was noted that 

in the available open literature there were several papers3

 documenting other Relevant Chemical 

products (halogenated organic compounds) that may be formed in low concentrations when 

applying Ozonation of seawater with a certain organic carbon content. 

3.3.4 It was further noted that the level of bromate and other oxidants in treated ballast water 

will depend on the organic content of seawater. An increase in the organic content will increase 

the oxidant demand of the seawater and thereby reduce the bromate (or the total residual 

oxidant – TRO) concentration. 

 

3

 .1 Driedger, A., et al. 2001. Inactivation of Bacillus subtilis spores and formation of bromate during 

Ozonation. Wat. Res. Vol. 35, No. 12, pp. 2950 – 2960. (included in the Korean application) 

 .2 von Gunten, U. & Hoigné, L., 1994. Bromate formation during ozonation of bromide-containing 

waters: bromate formation mechanisms. Environ. Sci. Technology, 32(1), pp.1234-1242. (included 

and referred in the Japanese application) 

 .3 Fabbricino, M. & G.V. Korshin, 2005. Formation of disinfection by-products and applicability of 

differential absorbance spectroscopy to monitor halogenation in chlorinated coastal and deep ocean 

seawater. Desalination 176 (2005), pp. 57 – 69. 
GESAMP-BWWG 2/9 

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Page 5 

I:\MEPC\55\2-16.doc 

4 PHYSICOCHEMICAL PROPERTIES 

4.1 The following table was copied directly from table 5 of the annex to MEPC 55/2. 

Physical property Ozone 

Bromate ion 

(Potassium bromate)

CAS number 10028-15-6 7789-38-0 

Molecule weight 48.0 2) 167.0 

Liquid concentration 1358g/L

(at -112°C)3) ―

Evaporation heat 15.2kJ/moL 3) ―

°Melting point -193°C 2) (350°C) 

Boiling point -112°C 2) (Decomposes at 370°C) 

Flammability Non-combustible but promotes burning of other 

substances. No inflammability to liquid2). ―

Density (20°C) 2.144g/L(N.T.P) 

(at 0°C, 101kPa) 3) (3.27 g/m3

) 

Vapour pressure (20°C; Pa) >1 atm4) ―

Vapour density 

(air=1) 

1.6 2)

(air=1) ―

Water solubility 0.1g/100mL 

(at 0°C)2)

7.5g/100ml (25°C) 

(133 g/l @ 40°C) 

pH in solution ― ―

Dissociation constant(pKa) Definition for liquid; no relation with gas. 8.62 

Oxidation reduction potential 2.07V 3、5) ―

Corrosivity to Material Yes Yes 

Reactivity to container material Yes ―

Auto ignition temperature (°C) 

Noncombustible but promotes burning of other 

substances. Various reactions may cause a fire or 

explosion.2)

―

Explosive Properties 

May cause a fire or explosion when heated or 

coming in contact with a combustible material 

(alkene, ether)2)

―

Oxidizing properties Yes missing 

Surface tension 

3.84×10-2N/mm 

(at -183°C)3) ―

Viscosity 1.57×10-3Pa.s (at -183°C)3) 66.6~67.6※

Thermal stability and 

breakdown product Oxygen ―

Other physical and Chemical 

property Nothing of noteworthy Oxidizing property 

※Value assuming the water coefficient of viscosity at 0°C to be 100 (density, 14.02~34.64wt%)

―:data not required 

4.2 It should be noted that the dashes indicate ”data not required” which might not be strictly 

correct. If it is not applicable or relevant then, perhaps this should be indicated and the reason 

given. 

5.0 HUMAN HEALTH HAZARDS 

5.0.1 Based on existing literature data concerning ozonation as a disinfection system and taking 

into account that the presence of bromide ion in the seawater leads to the formation of additional 

brominated DBPs (Disinfectant By-Products), the Group decided to consider bromoform also as 
GESAMP-BWWG 2/9 

ANNEX 5 

Page 6 

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Relevant Chemical and thus, whenever the information is available, to consider it along with 

bromate as to toxicological effects assessment. 

5.1 Acute toxicity 

5.1.1 The acute toxicity data evaluated by the Group are presented in the following tables: 

 Ozone 

Exposure Route Value range Species Reference 

Inhalation LC50 

(mg/L/4h) 

0.012 – 0.014 Mouse Cheminfo by CCOHS (Canadian Centre for 

Occupational Health and Safety) 

Oral LD50 (mg/kg bw) n.a. 

Dermal LD50 (mg/kg bw) n.a. 

n.a. not applicable 

 Bromate 

Exposure Route Value Range Species Reference 

Oral LD50 (mg/kg bw)) 280-495 Rats, Mice, and 

Hamsters 

WHO, 2005 

 Sub-acute toxicity

NOAEL oral (mg/kg 

bw/day) 2 weeks 

108 (based on changes in 

enzyme activities) 

SPF mice WHO, 2005 

 Bromoform 

Exposure Route Value Range Species Reference 

Oral LD50 (mg/kg bw)) 1388-1550 Rats and Mice EHC 216, 2000 

5.1.2 The Group accepted the non submission of oral and dermal toxicity data for ozone due to 

the fact that it is a gas and thus inhalation is the main exposure route of concern. However, it 

would be advisable that a justification covering this aspect was presented by the applicant. The 

same applies as above for the acceptance of missing inhalation and dermal toxicity data for 

bromate. 

5.1.3 Ozone: from submitted information and several studies in humans mentioned in literature 

(EHC 216, 2000), the group concluded that even very low doses of ozone can be harmful to the 

upper respiratory tract and the lungs. In addition, synergistic effects seem to exist, as exposure to 

very low concentrations initially increases reactivity of the airways to other inhaled substances 

(bronchial hyperresponsiveness) and cause inflammatory response in the respiratory tissue. 

Other symptoms observed following acute exposure to 0.5-1.5μg/L (0.25 - 0.75 ppm) include 

cough, shortness of breath, tightness of the chest, dyspnea, headache and nausea. More severe 

symptoms have been observed following concentrations higher than 0.002mg/L (1ppm) that 

included reduce lung function, extreme fatigue, dizziness, inability to sleep and cyanosis. An 

acute occupational exposure to approximately to 0.022mg/L (11 ppm) caused severe respiratory 

irritation and almost caused unconsciousness. A 30 min exposure to 0.1 mg/L (50 ppm) is 

considered potentially lethal. 

5.1.4 Bromate: lethal doses seem to be very similar across rodent species, also the toxic signs 

and symptoms; at autopsy, hyperaemia of the stomach was observed and congestion of the lungs. 

Also, damage to renal tubules including necrosis in the proximal tubular epithelium. Sub-acute 

adverse effects from bromate (potassium bromate) were reported in an oral study made with 

SPF mice during 2 weeks as changes in enzyme activities, at doses of 270mg/kg bw/day and 

above. A NOAEL was set at 108mg/kg bw/day (WHO, 2005). 
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5.1.5 Bromoform: among the brominated trihalomethanes THMs, bromoform is ranked as the 

least potent as a lethal acute oral toxicant. Toxic signs are reported relating to disruption of renal 

function. 

5.2 Effects on skin and eye 

5.2.1 Ozone: based on applicant’s submitted information (EHS, 1990), ozone seems not to 

cause any adverse effect on the skin but is irritating to the eyes when exposed to 

0.004mg/L (2ppm) for several minutes; other information (CCOHS) refers that ozone gas can 

probably cause skin irritation due to its oxidizing ability, but only at concentrations capable of 

causing severe respiratory injury. 

5.2.2 A summary of the skin and eye irritancy potential of ozone and bromate ions is shown in 

the following table: 

Ozone 

 Observation Species Reference/Comments 

Skin Not irritant EHP (1990) 

Eyes Irritant (>0.04mg/L for 

several minutes) 

Human EHP (1990) 

Bromate 

Skin Irritant Human RTECS 

Eyes Irritant Human RTECS 

5.3 Irritation to the respiratory tract 

The Group noted that inhalation exposure to ozone causes coughing and/or breathing difficulties 

at 0.03μg/L to 1.2μg/L (0.015-0.6 ppm) (information retrieved from MSDS). 

5.4 Repeated dose toxicity 

5.4.1 Ozone: from the available information, it was not possible to address the dose-response 

effects in relation to repeated inhalation exposure (sub-chronic, 90 days) to ozone. However, the 

Group may predict similar effects on the lungs of humans and other mammals even at low 

concentrations. In addition, it is referred in literature that the severity of respiratory responses 

seem to be reduced following repeated daily exposures due to an apparently “functional 

adaptation”. 

5.4.2 Bromate: it was noted that the exposure of rats to bromate for 15 weeks demonstrated a 

No Observed Adverse Effect Level (NOAEL) of 30 mg/kg bw/day. One study via oral route, 

made with F344 rats, for 13 weeks, showed, at a dose of 63 mg/kg bw/day, adverse effects with 

significant increases in blood serum parameters indicative of liver and kidney toxicity (including 

glutamate oxaloacetate transaminase, lactate dehydrogenase, cholinesterase and blood urea 

nitrogen). 

5.4.3 Bromoform: a 13-week study was performed in rats where a NOAEL 

of 25mg/kg bw/day could be derived on the basis of the absence of liver lesions whereas in the 

study in mice was 100mg/kg bw/day (NTP, 1989). 
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5.5 Chronic and long-term toxicity 

5.5.1 Ozone: in a series of well conducted studies, mice and rats exposed to 0.01-0.02mg/kg 

bw/day for 105 to 130 weeks had increased incidence of non-carcinogenic lesions of the nose and 

lungs (NTP,1994). Several studies also examined the effects of the long-term effects on 

monkeys. Exposures ranging from 0.003-0.013mg/kg bw/day for 3-18 months consistently 

showed significant structural alterations to lungs. Many of them seem to be irreversible 

six months after exposure stopped (COSHH). 

5.5.2 Studies in humans examining the potential effects of long-term occupational exposures to 

ozone have reported headaches, irritation to nose and throat, chest constriction and lung 

congestion in exposed workers. These studies suggest that long-term exposures to ozone may 

result in impaired lung function which is consistent with animal study results 

5.5.3 Bromate: the systemic toxicity of bromate (administered as potassium salt) has been 

reported from long-term studies designed to evaluate bromate carcinogenicity in F344 rats and 

B6C3F1 mice (WHO, 2005). The data show that the kidney is the major target organ of 

bromate-associated toxicity and that rats are more sensitive than mice to bromate treatment. 

5.5.4Following fifteen month exposure to 30mg/kg bw/day of bromate in drinking water, 

changes to the kidneys of the exposed rats were observed along with increased blood urea 

nitrogen and structural abnormalities of the cortical tubules. From these observations, NOAEL 

could not be determined but a LOAEL of 30mg of bromate/kg bw/day had been identified as part 

of the study. 

5.5.5 Bromoform was studied in a 2-year study with rats resulting in a small increase in 

tumours of the large intestine, at dose of 200mg/kg bw/day. 

5.6 Mutagenicity/Genotoxicity 

5.6.1 Ozone: there are a number of studies in literature to examine the potential for 

mutagenicity of ozone in humans but due to some deficiencies not all of them seem to be 

conclusive. 

5.6.1.1 However, the Group noted that positive results (cytogenetic aberrations) were observed in 

the lymphocytes of hamsters exposed to 0.0048-0.086mg/kg bw for 5 hours and in the lung 

macrophages of female rats exposed to 0.0024-0.016mg/kg bw for 6 hours. However, several 

studies have shown however, that ozone is mutagenic in bacteria and in mammalian and human 

cells in vitro following inhalation exposure (NTP, 1994; Mutation Research, 1992). 

5.6.2 Bromate: in particular potassium bromate, is considered mutagenic both in vitro and 

in vivo. In fact, positive results were obtained in bacteria test (Ames test), chromosome 

aberrations in cultured Chinese hamster fibroblast cells, acute cytogenetic effects on rat bone 

marrow cells and in the mouse micronucleus test. 

5.6.3 Bromoform: bromoform is largely positive in bacterial assays of mutagenicity and 

appeared to be more potent than the other brominated THMs. In vivo studies have given 

contradictory results. 

5.6.4 From the available information, the Group concluded that there may be a concern towards 

the mutagenicity/genotoxicity potential of ozone following inhalation exposure and towards 
GESAMP-BWWG 2/9 

ANNEX 5 

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subsequent brominated by-products, in particular potassium bromate, following oral exposure 

may be of concern. 

5.7 Developmental and reproductive toxicity 

5.7.1 Ozone: a study reported offspring of rats continuously exposed to 0.02 or 0.03mg/kg bw 

for four days during middle or late pregnancy had reduced growth rates after birth and delayed 

behavioural development. Maternal toxicity was not reported. 

5.7.1.1 Another study reported a decrease in foetal body weight gain in the offspring of mice 

exposed to 0.024 but not to 0.008 or 0.016mg/kg bw, on days 7-17 of pregnancy. Signs of 

maternal toxicity were observed (Tox. Applied Pharmac.,1979). 

5.7.2 Embryotoxicity (increased resorptions) was observed in rats exposed to 0.03 and 

0.04mg/kg bw, but not 0.013-0.025mg/kg bw. Maternal toxicity was not reported (COSHH). 

5.7.2.1 Continuous exposure of mice from six days prior to mating to postnatal day 22 resulted in 

reduced body weight and slight effects in neurobehaviour development of the offspring. 

Maternal toxicity was not evaluated (Arch.Toxicology, 1995). 

5.7.3 No effects on reproductive performance (proportion of successful pregnancies, litter size, 

offspring viability and sex ratio) were noted in mice exposed for 6 days prior to mating to 

postnatal day 22 (dose was not referred) (Arch.Toxicology, 1995). 

5.7.4 Bromate: no effects on reproductive performance had been observed in a study made 

with rats and mice fed with 15mg potassium bromate per kg body weight over five and eight 

generations, respectively. Based on the test results, the Group concluded that bromate does not 

indicate to have developmental or reproductive toxicity. 

5.7.5 Bromoform: Ruddick et al. (1983) conducted a teratological investigation in 

Sprague-Dawley rats, where bromoform was administered by gavage at dose of 50, 100 or 

200mg/kg bw/day on gestation days 6-15. Evidence of foetotoxic response was observed, but 

there were no foetal malformations. This study was used to examine effects on fertility and 

reproduction in Swiss CD-1 female rats. There were no detectable effects of bromoform on 

reproduction function. Bromoform was found to induce resorption in F344 pregnant rats, at 

higher doses (150 and 200mg/kg bw/day). 

5.8 Carcinogenicity 

5.8.1 Ozone: no data were submitted by the applicant for the carcinogenicity potential 

assessment of ozone. From a study with rats and mice exposed to 0.0024, 0.01 and 

0.02mg/kg bw of ozone for 105 to 130 weeks, there was no evidence for carcinogenicity in male 

and female rats, inconclusive evidence in male mice, and some evidence in female mice. Ozone 

did not have tumour promoter properties (NTP, 1994). 

5.8.2 No human carcinogenicity information related to ozone exposure is available. The 

American Conference of Governmental Industrial Hygienists (ACGIH) has designated this 

chemical as not classified as a human carcinogen (A4). 

 

5.8.3 Bromate: is an active oxidant in biological systems and has been shown to cause an 

increase in renal tumours, peritoneal mesotheliomas and thyroid follicular cell tumours in rats, 
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and to a lesser extent in hamsters and mice. The lowest dose at which an increased incidence of 

renal tumours was observed in rats was 6mg/kg bw/day. 

5.8.4 A clear dose-response relationship has been observed in tumour incidence and the 

severity/progression of tumours. The weight of evidence clearly indicates that bromate has the 

potential to be a human carcinogen. 

5.8.4.1 IARC classified it in Group 2B (possible human carcinogen). 

5.8.5 Bromoform: IARC has evaluated carcinogenicity of bromoform and concluded that there 

is inadequate evidence for its carcinogenicity in humans and limited evidence for its 

carcinogenicity in experimental animals. IARC classified Bromoform in Group 3 (not classifiable 

as to its carcinogenic potential to humans). 

5.9 Toxicokinetics 

5.9.1 Ozone: is absorbed in both the upper and lower respiratory tract. It is a potent oxidant that 

reacts with protein and lipids, particularly within biological membranes. A small amount of 

inhaled ozone is absorbed into the blood. The extreme reactivity of ozone limits its ability to 

accumulate. 

5.9.2 Bromate: following from oral administration, bromate is rapidly absorbed from the 

Gastro Intestinal Tract (GIT). It was not detected in rat tissues following intragastric dose, but 

was significantly increased in plasma, red blood cells, pancreas, kidneys, stomach, and small 

intestine. 

5.9.3 Bromate may be converted into hypobromic acid by hypochloric acid in the stomach. 

Liver and kidney tissues may degrade bromate to bromide by a process involving glutathione, 

although only small amounts appear to be reduced in this way. Bromate is excreted mainly by 

urine as bromate and bromide; some may also be eliminated by faeces. Bromate concentrations 

in urine peak at about 1h, and bromate is not detectable in plasma after 2h. 

 

5.9.4 Bromoform: toxikocinetic information was not found by the Group however some 

considerations can be draw. Although bromoform appear to have greater propensity for 

metabolism, it appears to be less potent toxicant and carcinogen based on the NTP (1985,1987) 

bioassays and numerous in vivo toxicity studies. A possible explanation is less bioavailability 

resulting from the greater lipophilicity of this compound (logPow~240) which, together with 

greater reactivity of bromoform metabolites, may also prevent it from reaching critical target 

sites.

5.10 Conclusions from Human Health Hazard Assessment: 

5.10.1 From the human health effects assessment and taking into consideration the substances at 

the effective concentrations in the disinfection process described in the Japanese Application 

Dossier, the Group is able to reach the following conclusions: 

5.10.2 Ozone: Ozone is very toxic by inhalation route and it is, therefore, highly 

recommendable to apply strict mitigation measures to avoid human inhalation exposure during 

the process. In addition, by oral exposure and due to its oxidant properties, there may be a 

concern towards ozone potential for mutagenicity. 
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5.10.3 Bromate (potassium bromate): Several studies indicate high potential for mutagenicity/ 

carcinogenicity in humans. The current MCL (Maximum Contaminant Level) in the United 

States is 0.010mg/L and the maximum contaminant level goal is zero, because of the possibility 

that bromate may function as a genotoxic carcinogen. Therefore the exposure should be totally 

avoided. 

5.10.4 Bromoform and other brominated DBP: as highly reactive compounds capable of 

bioaccumulating, exposure to these on the long-term should be minimized. 

5.10.5 Other relevant factors which have to be taken into account when assessing human 

exposure towards chemicals include: 

 .1 the variability in individual sensitivity; and 

 .2 the fact that complex mixtures of disinfectants and DBPs, according to the actual 

knowledge, interact in an additive way, at low concentration. Therefore, the 

Group raised an additional concern about the potential for cumulative 

toxicological effects of the mixture of chemicals generated by the system proposed 

by the Japanese Application. 

6 RISKS TO SAFETY OF SHIP AND CREW 

6.1 The submission recognises and identifies that the use of ozone as an Active Substance 

presents a potential risk to the crew in that ozone in the atmosphere in relatively small quantities 

is an irritant and in slightly higher concentrations is acutely toxic. Recognised National standard 

permitted values for maximum average levels for ozone can be as low as 0.05ppm/24hr (State of 

New York). The applicant indicated that the risk of exposure of the crew to ozone is mitigated 

by the provision of ozone densitometer monitoring to areas that may be affected by leakage from 

the system linked to visible and audible alarms and an automatic system shut down function 

together with ozone level monitoring at the ballast tank air vents. The inclusion of a gas 

separation unit together with a waste ozone destruction unit after the treatment unit further 

reduces the risk of free ozone being released in the ballast tank. 

6.2 The group considers the BWMS risk reduction measures proposed adequately mitigate 

concerns relating to the use of ozone as an Active Substance to an acceptable risk level. It is also 

recognised that in most cases the presence of ozone is readily identifiable in small concentrations 

by smell. It is recommended that placards giving additional warnings of the hazards related to 

the inhalation of ozone be provided onboard to promote a general awareness. 

6.3 The Group noted that the submission reasons that only a negligible amount of material 

will be generated by reaction with organic matter when using ozone as a disinfectant. However, 

other studies have determined that, in sea water, the production of carcinogenic brominated 

trihalomethanes (THMs), including bromoform, may be significant. 

6.4 As a result, the Group recommended that the THM levels in the ballast tank are regularly 

measured during the further prototype development and testing period and that precautionary 

measures to mitigate any risk to the crew from contact with THMs are put in place until it can be 

demonstrated that the risk is negligible. 
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6.5 It was considered that the system configuration could potentially produce significant 

noise with a possibility of affect to the health of crew working in the vicinity of the system. It is 

recommended that operational noise levels are monitored during shipboard trials and verified to 

remain within the IMO accepted limits for machinery spaces. 

6.6 The submission identifies the risk of corrosion arising from the oxidizing effects of ozone 

and concludes that the only areas requiring materials with additional corrosion resistance 

properties such as stainless steel are those contained within the additional requirements for the 

provision of the BWMS. It is recommended that the initial assessment of a limited corrosive 

effect is verified by regularly monitoring the actual conditions of the ships ballast system piping, 

protective coatings and ballast tank structure during the onboard trial period. 

7 ENVIRONMENTAL FATE AND EXPOSURE 

7.1 Environmental fate and behaviour properties 

7.1.1 The Group noted that when ozone is injected into ballast water it reacts with both the 

natural organic and inorganic compounds and it depredates with a half-life of about six sec. to 

30 sec. Some of the degradation rates for dissolved ozone are shown in Table T7.3 below. Even 

in the ballast tank, dissolved ozone exists in a very short time, and during the degradation process 

it produces some oxidants. 

7.1.2 The Group also noted that main fate considered in the ballast tank and marine 

environment is that of those oxidants. 

Table T7.1 Overview of fate for dissolved ozone in water media 

. Degradation Rate for ozone 

Test 

Substance 

1⁄2 Life Time Degradation 

Process 

References 

Ozone 

(sea water) 5.8sec Abiotic Theoretical rate (W.Haag et al.,1983) 

Ozone 

(sea water) 5.3 sec Abiotic Theoretical rate (W.Haag et al.,1983) 

Ozone 

(fresh water) 30 min Abiotic Theoretical rate (Siddiqui M.S. et all,1995) 

7.2 Fate in ballast water tanks 

7.2.1 Some of the main reactions when ozone is injected into seawater are shown below: 

 .1 O3 + Br → O2 + OBr 

 .2 O3 + OBr → 2O2 + Br 

 .3 2O3 + OBr → 2O2 + BrO3

-

 .4 Br- + O3 ↔ OBr 

 .5 OBr-

 + H+ ↔ HOBr 
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 .6 HOBr + Organic matter → CHBr3 

 .7 HOBr + NH3 ↔ NH2Br 

7.2.2 The application dossier claims that the reaction #6 and #7 do not occur in the high pH(>8) 

and water with high contents of bromium compounds. However, with reference to its comments 

in Section 3.3 the Group recommended that this process should be analysed further. 

7.2.3 The Group noted that two methods for identification of the concentration of bromate ion 

in treated ballast water are applied (ion chromatogram and iodine titration). It was, however, not 

always clear for the Group which of these methods that were applied in the toxicity and 

degradation tests carried out by the applicant and included in the dossier. 

7.2.4 The results of analyses applying iodine titration include all oxidants present in the treated 

ballast water and is given as mg TRO per litre (TRO = Total Residual Oxidant) in the dossier. 

As several Relevant Chemicals may be present in the treated ballast water, the Group 

recommended that toxicity data and degradation data found in analyses of the treated ballast 

water are related to TRO and not only to the concentration of bromate ion. 

7.2.5 The dossier states that the initial concentration of Active Substance in the ballast tanks 

is 3.3 mg/l given as TRO depending on salinity, organic content, pH and other properties of the 

treated water. TRO is degraded through a number of reactions between the oxidants and other 

natural chemicals in the sea water. 

7.3 Fate in the environment 

7.3.1 It was noted that the dossier presented a various number for the degradation rates of 

Active Substances and Relevant Chemicals, they are summarised as follows. 

Table T7.2 Overview of fate of Relevant Chemicals in seawater 

. Degradation Rate for Relevant Chemicals 

Test 

Substance 

1⁄2 Life Time Degradation 

process 

References 

Bromate ion ~12h Abiotic MEPC55/2, p8,No Ref. 

Bromate ion 226 sec Biotic Ref.26 

TRO 15h 

Abiotic Dossier 

Comment: Measured value in low TOC 

natural seawater(1.1mg-TOC/l) 

7.3.2 In general, the degradation rate of TRO in the clean natural sea water given in the dossier 

is similar to other available studies and dossiers. 

7.3.3 The group noted that the dossier did not include any information about degradation rates 

in sediment and freshwater for bromate ions or TRO. 

7.3.4 Bioaccumulations 

The Group noted that the bromate ion is not bioaccumulative. Data for bromoform is not given in 

the dossier, but is included in the table (T7.3) below. 
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Table T7.3 Bioaccumulation data for Relevant Chemicals 

 Bioaccumulation (B) 

Test Substance Log Pow B criterion fulfilled 

(Yes/No) 

Ozone Missing 

(<1) No 

Bromate ion <1 No 

Bromoform 2.40 No 

7.4 Environmental exposure 

7.4.1 From the results of the different characteristics of the chemicals in the Japanese 

application the Group concluded that TRO would be the most important group of chemicals to 

take into account for the risk assessment, excluding bromoform. In the dossier, the 

environmental exposure was estimated using the model MAM-PEC, for the port of Rotterdam. 

An overview of the assumptions of the 4 scenarios is given in table T7.4. 

Table T7.4 Exposure scenarios considered. 

# Resulting maximum 

concentration 

(mg/L) 

Scenario description 

1 0.16 anticipated normal concentration in ballast water 48h after 

ozone treatment with discharge treatment 

2 1.6 concentration following the maximum concentration of ozone 

treatment 

3 3.44 average concentration immediately after ozone treatment 

4 4.56 anticipated concentration without discharge (decomposition) 

treatment 

7.4.2 According to the submission, the model predicts that average concentrations of TRO in 

the water of the harbour after a period of 10 years in use are estimated to amount: 0.278, 2.78, 

5.81 and 7.93 μg/L, respectively. 

7.4.3 As these results were obtained with a model that has not yet been evaluated by the Group 

or a body of IMO, the Group considered that these results should be interpreted with care and be 

only used as indicative. The Group also noted that the Rotterdam harbour scenario was based on 

an average dilution of treated ballast water after discharge of more than 1,000 times and that in 

many other environments and even in some basins of Rotterdam harbour, such a high dilution 

might not be found. Relevant scenarios should be developed and agreed upon before 

representative environmental exposure concentrations can be estimated. 
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8 ENVIRONMENTAL EFFECTS 

8.1 Aquatic toxicity of Active Substance & Relevant Chemical 

8.1.1 Acute aquatic toxicity 

The data on the acute toxicity of the Active Substance and the Relevant Chemical is shown in 

table T8.1. 

Table T8.1 Overview of acute toxicity data. 

Test 

Substance 

F 

C 

A 

Species Effect Value (mg/L) 

F Oncorhynchus mykiss 96h LC50 0.0093 

Ozone C Missing 

A Missing 

F Cyprinus carpio 41h LC50 0.26 

C Polycelis nigra 24h LC50 32 

M Crassostrea gigas 24h NOEC 32 

Bromate 

ion 

A Missing 

 F = Fish, C = Crustacea, A = Algae, M = Molluscs 

8.1.2 Chronic aquatic toxicity 

8.1.2.1 The data on the chronic toxicity of the Active Substance and the Relevant Chemical is 

shown in table T8.2. 

Table T8.2 Overview of chronic toxicity data. 

Test 

Substance 

F 

C 

A 

Species Effect Value (mg/L) 

F Oncorhynchus mykiss 90d NOEC 0.005 

Ozone C Missing 

A Missing 

F Missing 

C Missing Bromate 

ion A Skeletonema costatum 7d NOEC 0.125 

8.1.3 Derivation of the Predicted No Effect Concentration (PNEC) 

8.1.3.1 As the group accepts the minor role of ozone after the treatment of the ballast water the 

risk assessment has been focussed on bromate ion. Therefore only for bromate the PNEC has 

been derived. The acute toxicity data presented in the Table T8.1 is considered complete for 

bromate but Table T8.2 does not show a complete data set for the chronic toxicity of bromate. 

8.1.3.2 To establish the PNEC the lowest value of the acute and of the chronic data are 

considered: 41h LC50 = 0.26 mg/L for Cyprinus carpio and 7d NOEC = 0.125 mg/L for 
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Skeletonema costatum. Applying an assessment factor of 1000 to the first and of 100 to the 

second reveals a PNEC of 0.26 μg/L as the lowest value. Furthermore, no chronic toxicity data 

are available for the most sensitive group of species (fish). Therefore, the value of 0.26 μg/L is 

considered the PNEC. 

8.2 Aquatic toxicity of treated ballast water 

8.2.1 The Group noted that the Company had indicated that there were no existing chronic 

toxicity data for either ozone or bromate ions. However, chronic toxicity tests had been carried 

out on the treated ballast water containing bromate ions following treatment with ozone at the 

maximum recommended rate of 4mg/L. The results of these experiments are show in Table T8.3. 

Table T8.3 Results of chronic toxicity experiment. 

Test 

Substance 

F 

C 

A 

Species Effect Value 

F Oryzias javanicus 21d NOEC 100% treated ballast 

water 

C Hyale barbicorins 21d NOEC 100% treated ballast 

water 

Treated ballast 

water containing 

bromate ions 

(0.16 mg/L as 

TRO) A Skeletonema costatum 72h NOEC 100% treated ballast 

water 

8.2.2 The Group concluded from this experiment that no chronic toxicity of treated ballast 

water was measured and, furthermore, that exposure of the environment will not exceed a 

concentration of 0.16 mg/L as TRO. 

9 ENVIRONMENTAL RISK CHARACTERIZATION 

9.1 PBT assessment 

9.1.1 Based on the assessment of PBT shown in the table below, the Group agreed that neither 

ozone nor bromate ion should be classified as PBT chemicals 

Compound Persistence (P) 

1⁄2 Life: 

>60d in seawater 

>40d in freshwater 

>180d in sea sediment 

>120d in fw sediment 

Bioaccumulation (B) 

BCF > 2000 

Log Pow >3 

Toxicity (T) 

Chronic NOEC<0.01 mg/l 

Ozone No No Yes 

Bromate ion No No No 

9.2 Assessment of treated ballast water 

9.2.1 According to the experiment carried out (see section 8.2) it was established that a 

concentration of 0.16 mg/L of TRO did not affect several organisms after treatment of 100% 

ballast water with ozone. 
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9.2.2 However, the group considered that there was a discrepancy between the toxicity data 

available on bromate (see Tables T8.1 and T8.2) resulting in a derived PNEC for bromate of 

0.26μg/L and the concentration of bromate in treated ballast water at 0.16 mg/L causing no effect 

in the chronic toxicity tests with treated ballast water (cf., Table T8.3). 

9.2.3 As a result it was agreed that before a final assessment can be made, further information 

or clarification is needed on this point. 

9.3 Environmental risk assessment 

9.3.1 The Group noted that the half-life for ozone in seawater was 5.3 s to 30 min. depending 

on the ambient conditions and so would be degraded prior to being released into the marine 

environment. 

9.3.2 It was noted that the lowest measured acute toxicity for bromate ions was 0.26mg/l and 

that the lowest chronic No Effect Concentration (NOEC) for bromate ions was 0.125mg/l 

resulting in an estimated PNEC of 0.26μg/L whilst the concentration of bromate ions in the 

ballast water prior to discharge was commonly 0.16 mg/l (measured as TRO). 

9.3.3 However, the Predicted Environmental Concentration (PEC) in the Rotterdam harbour 

had been calculated using the MAM-PEC model (version 1.6) for the following concentrations of 

the bromate ions measured as Total Residual Oxidant (TRO) which might be present in ballast 

water prior to discharge: 

 .1 0.16 mg/l anticipated normal concentration 48h after ozone treatment with 

discharge treatment; 

 .2 1.6 mg/l anticipated concentration without discharge (decomposition) 

treatment; 

 .3 3.44 mg/l average concentration immediately after ozone treatment; and 

 .4 4.56 mg/l concentration following the maximum concentration of ozone 

treatment. 

9.3.4 It was noted that cases .3 and .4 were both accidental discharges which are not realistic to 

model for a 10 year period. The PEC values for scenarios 3 and 4, given in the Table 9.1 below, 

are therefore highly conservative. 

Table T9.1 Risk assessment for bromate (as TRO) 

Bromate 

discharge 

PEC in harbour after 10y 

(μg/l) 

PNEC 

(μg/l) 

PEC/PNEC 

0.16 mg/l 0.722 0.26 2.78 

1.6mg/l 7.22 0.26 27.8 

3.34mg/l 15.1 0.26 58.1 

4.56mg/l 20.6 0.26 79.2 

9.3.5 It was noted that on page 16 section 9.2 in the dossier the applicant concluded that long 

term effects will be sufficiently secured without decomposition treatment. However, the Group 

considered that this was an analysis performed without the use of an assessment factor. As a 

result, it was agreed that treatment at discharge (decomposition treatment) would be necessary to 

achieve PEC/PNEC values below 1. 
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9.3.6 These results of the model MAM-PEC should be evaluated with care and should be 

considered as indicative values only. As suitable emission scenarios are not available to the 

Group, it would be useful to evaluate potential models, in future, for their usefulness in the 

evaluation of Active Substances under G9. 

9.3.7 Based on this estimation, the risk for aquatic organisms after exposure to bromate ions 

produced during ozone treatment of ballast water cannot be ruled out. 

9.3.8 Bromoform: The applicant considered the substance bromoform not as a Relevant 

Chemical. However, the GESAMP BWWG does not agree with this. Although bromoform may 

be formed in quite small quantities the mere possibility of formation of bromoform together with 

the known characteristics, phys/chem., fate, ecotoxicity and mammalian toxicity, the Group 

considers that an assessment of the formation of bromoform should be done before application 

for Final Approval. 

10 CONCLUSIONS AND RECOMMENDATIONS 

10.1 Risks to safety of ships 

10.1.1 It was noted that the applicant had indicated that the need for corrosion resistant 

materials, due to the corrosive effect of ozone, would be limited to the additional piping and 

equipment required for the fitting of the treatment system. 

10.2 Risks to crew 

10.2.1 It was recognized that, as ozone is generated as required, there will not be a need to store 

the Active Substance. As a result, the only potential exposure of the crew will be from leaks 

around the generator and its associated piping when the ballast water is being treated. 

10.2.2 However, the Group noted that there was a potential risk to the health of the crew arising 

from the exposure to ozone from accidental system leakage. It was acknowledged that the 

submission recognised this risk and identified onboard risk control measures to be put in place 

that will reduce the possibility of crew exposure to ozone if a plant leakage should occur. The 

group also identified the possibility that brominated trihalomethanes (THM’s), which are known 

to be potentially carcinogenic, could be present in the ballast tanks as a consequence of the 

disinfection process, and that this potential risk to crew health should, eventually, be further 

explored by monitoring this class of chemicals. It was also felt that there was a possibility that 

the process itself could give rise to excessive noise levels in the vicinity of the treatment unit. 

10.2.3 This potential exposure scenario affects the way the hazardous properties of the Active 

Substance and Relevant Chemicals need to be considered when evaluating the risks to the crew. 

10.3 Risks to the environment 

10.3.1 Under normal operating conditions it is expected that the discharge concentration of TRO 

will be about 0.16 mg/L as TRO. Compared with the derived PNEC for bromate of 0.26μg/l, 

a dilution of more than 500 times would be required before long-term toxicity can be avoided. 

The Group was not aware of information that allows an evaluation of whether this can be 

obtained under realistic and representative conditions. 
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10.3.2 However, provided that a sufficient dilution of discharge ballast water can be assured, the 

Group was of the opinion that prototype development and testing could be conducted without 

unreasonable risks to the aquatic environment. This conclusion does not prejudice any future 

conclusions regarding environmental risks associated with full-scale operational implementation 

of the proposed BWMS. 

10.3.3 Moreover, the formation of the chemical bromoform has not been considered as a 

potential hazard. According to the Group, this substance should have been identified as a 

Relevant Chemical and, therefore, an appropriate Risk Assessment should have been carried out. 

10.4 Recommendations 

10.4.1 Having considered the available information the Group recommended that Basic 

Approval is given to this proposal. The Group also recommended that Basic Approval should be 

limited to further prototype development and type approval testing only. 

10.4.2 Furthermore, the Group recommended that the following conditions should apply during 

the further development and testing of the proposed system: 

.1 due consideration should be given to the fact that the risk assessment currently 

performed has been based upon an incomplete data set and therefore the risk 

assessment should be considered as indicative only. A complete data set may 

result in a different conclusion. 

.2 due consideration should be given to the fact that the information on the substance 

bromoform as a possible Relevant Chemical is considered insufficient for a risk 

assessment on this chemical on all topics, therefore, additional information should 

be provided on this substance. 

.3 the discharge from the “waste ozone destruction unit” should be suitably sited and 

included to the ozone monitoring and alarm system; 

.4 it should be confirmed that the levels of THM and free ozone in the ballast tanks 

remain acceptable. Additional safety precautions should be put in place until such 

confirmation is obtained; 

.5 it should be confirmed that noise levels when the system is in operation remain 

within permitted levels for machinery spaces; and 

.6 it should be confirmed that the initial assessment that the corrosion effect will be 

limited, and that there is no additional corrosion effect to ballast piping, ballast 

tanks or degradation of protective coatings resulting from use of the system. 

.7 the apparent discrepancy between the measured chronic toxicity of the treated 

ballast water and the assessment of bromate should be investigated further. 

Awaiting the results of such investigations, the discharge of ballast water treated 

with ozone during further development and testing should only take place under 

controlled conditions and into an environment where a sufficient dilution can be 

assured for avoiding unreasonable risks to the aquatic environment. 
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10.4.2 The Group suggested that MEPC invites the Administration of Japan to ensure that all the 

above conditions are taken into account and appropriate measures are put in place during further 

development and testing of the Special Pipe Ballast Water Management System (combined with 

Ozone treatment). 

10.4.4 Furthermore, the group emphasized that it could not judge whether a full-scale 

deployment would cause unacceptable environmental damage as no representative and realistic 

emission scenarios are available. Consequently, suitable realistic scenarios describing emissions 

of treated ballast water into representative water courses should be developed, documented and 

applied for assessing the environmental risks under full-scale deployment of the proposed 

system. Such scenarios should describe various release situations with regard to dimensions of 

the receiving environment, water flow and exchange, number of ships, frequency, duration and 

volume of discharges of treated ballast water, etc. The Group encouraged MEPC to consider the 

development and agreement of such emission scenarios, which should then be applied by the 

applicant in an eventual application for Final Approval. 

*** 
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I:\MEPC\55\2-16.doc 

ANNEX 6 

REVIEW OF PROPOSAL FOR APPROVAL OF ACTIVE SUBSTANCE 

Ozone - submitted by the Republic of Korea 

0 SUMMARY 

0.1 The Group noted that the application took the form of a general concept for a system to be 

developed. As such, there were no firm proposals for the actual BWMS to be installed and so 

this aspect could not be evaluated. 

0.2 The Group noted that the applicant had identified bromate ions and bromoform as 

Relevant Chemicals formed as by-products from treating ballast water with ozone. 

0.3 The Group noted that bromate ion has a high potential for mutagenicity and 

carcinogenicity and therefore human exposure should be avoided completely. This is particularly 

important if the crew has to enter a ballast water tank after treatment. 

0.4 However, as the application only provided generic details on the safety requirements for 

the proposed system, it was not possible to evaluate it adequately. In addition, no information 

was supplied regarding the potential corrosivity of the Active Substance or Relevant Chemicals 

to the materials of construction of the ship and the associated equipment to be used in the 

proposed system. 

0.5 As no information had been provided on the dose of ozone to be used in the application, 

the Group could not give an estimation of the concentration levels of ozone and Relevant 

Chemicals expected to be found in the environment. 

0.6 However, the Group anticipated that ozone would not present an environmental risk due 

to its short half-life but the levels of bromate ions (TRO) and bromoform would need to be 

thoroughly investigated before a recommendation related to Basic Approval could be anticipated. 

0.7 Due to the lack of required data, the Group were unable to carry out any meaningful Risk 

Assessment and so do not recommend that this system be given Basic Approval 

1 INTRODUCTION 

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

support its submission MEPC 55/2/3 and supplemented by additional information identified by 

the Group. Where more than one value were identified for any of the properties, only those 

considered by the Group to be the most relevant were included in this summary dossier. 

2 COMPLETENESS OF DOSSIER 

2.1 The Group noted that information about the following subjects was not included in the 

dossier: 
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 .1 quality control/quality assurance programme implemented in the testing process of 

the Ballast Water Management System; 

 .2 an overview of the ballast water management system (BWMS) with description of 

the components of the system; 

 .3 an overview of how the BWMS may be integrated to the ships ballast water 

system and how control of the system is to be effected; 

 .4 the planned dosage of ozone to be injected into the ballast water and applied in 

several of the experiments presented in the dossier. This information was later 

provided by request from the Group in a meeting with technical experts from the 

applicant and in an email dated 25 May 2006; 

 .5 how ozone will be injected into the ballast water pipe; 

 .6 safety considerations regarding the presence of free ozone in the ballast tanks; and 

 .7 a full consideration of the corrosive implications arising from the use of ozone. 

3.0 DESCRIPTION OF BWMS 

3.0.1 It was noted that the submission indicates the intention to select a ship, design a single 

point Ozone injection system for this ship, install the system and test effectiveness. Only the 

general concept for such a system was provided with no firm proposals for the actual BWMS to 

be installed. The generic safety requirements for an ozone system were provided. 

3.1 Application 

3.1.1 It was noted that the only component of the BWMS identified in the dossier was the 

application of ozone generated onboard as ballast water treatment to be applied through a single 

point injection system. 

3.1.2 The submission indicated that whilst ozone has been used to disinfect drinking water 

safely , the presence of bromide ions in seawater leads to the formation of bromate ions and 

bromoform which is not the case with drinking water. 

3.2 Active Substance(s) 

3.2.1 The Active Substance in this BWMS is ozone. 

3.2.2 When ozone is injected into seawater, it was noted that the applicant had indicated that 

the following Relevant Chemicals will be formed: 

 .1 bromate ion (BrO3

-

) is produced from the reaction of ozone with bromides in 

seawater. It will be found as an equilibrium between bromate ion, hypbromous 

acid and sodium bromate; and 

 .2 bromoform (CHBr3) is produced from the reaction of ozone with naturally 

occurring organic matter in water used for ballast. 
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3.2.3 It was noted that another proposal submitted for the use of ozone as the Active Substance 

to treat ballast water, did not indicate that bromoform would be produced in potentially 

significant amounts. 

3.2.4 Identity of Active Substance and Relevant Chemicals 

3.2.4.1 Table T3.1 gives the information on the identity of the Active Substance whilst 

Table T3.2 gives the identity information for the Relevant Chemicals. 

Table T3.1 Identification on the Active Substance. 

Chemical 

name 

CAS number 

(UN number) 

Molar mass Empirical 

formula 

Structural 

formula 

Purity 

Ozone 10028-15-6 

(1956) 

48.00 O3 10 – 15% 

w/w 

Table T3.2 Identification on the Relevant Chemicals. 

Chemical 

name 

CAS 

number 

(UN 

number) 

Molar mass Empirical 

formula 

Structural formula Purity 

Hydrogen 

hypobromite 

13517-11-8 96.91 HOBr HO-Br By-product 

Bromoform 75-25-2 

(2515) 

252.73 CHBr3 By-product 

Bromate ion 15541-45-4 127.90 BrO3

-

 

 

By-product 
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4 PHYSICOCHEMICAL PROPERTIES 

4.1 The following table (T4.1) shows the properties of the Active Substance (Ozone) and 

Relevant Chemicals. 

Table T4.1: Physicochemical properties of Active Substances and Relevant Chemicals 

Physical property Ozone Sodium bromate Potassium bromate Bromoform 

CAS number 10028-15-6 7789-38-0 7758-01-2 75-25-2 

Molecule weight 48 150.90 167.01 252.77 

Melting point Missing 38°C ???? 350°C 8.0-8.5 °C 

Boiling point -111.9°C Missing At 370°C decomposes 149.5 °C 

Flash point Missing Missing Missing Missing 

Density (20°C) 2.14 kg/m3

 3.339g/m3 3.27 g/m3 Missing 

Vapour pressure @ 

20°C (Pa) 5460000 Missing Missing 0.667 

Vapour density 

(air=1) 2.144 g/l @ 0°C Missing Missing 8.72 (air = 1) 

(calculated) 

Water solubility Missing 275 g/l @ 0°C 

909 g/l @ 100°C 

133 g/l @ 40°C 

497.5 g/l @ 100°C 3100mg/l (25°C) 

pH in solution Missing Missing Missing Not available 

Octanol / water 

partition coefficient 

(log Pow) 

 0.38 

Dissociation 

constant(pKa) Missing Missing Missing 2.06 

Oxidation reduction 

potential 2.07 Eo(V) Missing Missing Missing 

Corrosivity to 

Material Yes Missing Missing Not corrosive 

Reactivity to 

container material Missing Missing Missing Missing 

Auto ignition 

temperature (°C) Missing Missing Missing Missing 

Explosive 

Properties Yes Missing Missing Missing 

Oxidizing 

properties 

Powerful 

oxidiser Missing Missing Missing 

Surface tension Missing Missing Missing 46.18 mN/m at 15 °C 

Viscosity Missing Missing Missing 2.15 mPa.s (dynamic) 

Thermal stability 

and breakdown 

product 

Missing Missing Missing Gradually decomposes at 

elevation of temperature 

Other physical and 

Chemical property Missing Missing Missing Missing 

4.2 It should be noted that the missing data in the table T3 above might be important for a full 

assessment. If it is not applicable or relevant then this should be indicated and the reason given. 

5 HUMAN HEALTH HAZARDS 

5.0.1 Based on existing literature data concerning ozonation as a disinfection system and taking 

into account that the presence of bromide ion in the seawater leads to the formation of additional 

brominated DBPs (Disinfectant By-Products), the Group decided to treat bromoform also as 

Relevant Chemical and thus, whenever the information is available, to consider it along with 

bromate as to human toxicological effects assessment. 
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5.1 Acute toxicity 

5.1.1 The acute toxicity data evaluated by the Group are presented in the following tables: 

 Ozone 

Exposure Route Value range Species Reference 

Inhalation LC50 (mg/L/4h) 0.012 – 0.014 Mouse Cheminfo by CCOHS (Canadian Centre for 

Occupational Health and Safety) 

Oral LD50 (mg/kg bw) n.a. 

Dermal LD50 (mg/kg bw) n.a. 

n.a. not applicable 

 Bromate 

Exposure Route Value Range Species Reference 

Oral LD50 (mg/kg bw)) 280-495 Rats, Mice, and Hamsters WHO, 2005 

 Sub-acute toxicity

NOAEL oral (mg/kg 

bw/day) 2 weeks 

108 (based on changes in 

enzyme activities) 

SPF mice WHO, 2005 

 Bromoform 

Exposure Route Value Range Species Reference 

Oral LD50 (mg/kg bw)) 1388-1550 Rats and Mice EHC 216, 2000 

5.1.2 The Group accepted the non submission of oral and dermal toxicity data for ozone due to 

the fact that it is a gas and thus inhalation is the main exposure route of concern. However, it 

would be advisable that a justification covering this aspect was presented by the applicant. The 

same applies as above for the acceptance of missing inhalation and dermal toxicity data for 

bromate. 

5.1.3 Ozone: from submitted information and several studies in humans mentioned in literature 

(EHC 216, 2000), the group concluded that even very low doses of ozone can be harmful to the 

upper respiratory tract and the lungs. In addition, there seems to exist synergetically effects, as 

exposure to very low concentrations initially increases reactivity of the airways to other inhaled 

substances (bronchial hyperresponsiveness) and cause inflammatory response in the respiratory 

tissue. Other symptoms observed following acute exposure to 0.5-1.5μg/L (0.25 - 0.75 ppm) 

include cough, shortness of breath, tightness of the chest, dyspnea, headache and nausea. More 

severe symptoms have been observed following concentrations higher than 0.02mg/L (1ppm) 

that included reduce lung function, extreme fatigue, dizziness, inability to sleep and cyanosis. 

An acute occupational exposure to approximately to 0.022mg/L (11 ppm) caused severe 

respiratory irritation and almost caused unconsciousness. A 30 mn exposure to 0.1 mg/L 

(50 ppm) is considered potentially lethal. 

5.1.4 Bromate: lethal doses seem to be very similar across rodent species, also the toxic signs 

and symptoms; at autopsy, hyperaemia of the stomach was observed and congestion of the lungs. 

Also, damage to renal tubules including necrosis in the proximal tubular epithelium. Sub-acute 

adverse effects from bromate (potassium bromate) were reported in a oral study made with 

SPF mice during two weeks as changes in enzyme activities, at doses of 270mg/kg bw/day and 

above. A NOAEL was set at 108mg/kg bw/day (WHO, 2005). 

5.5.5 Bromoform: among the brominated THMs, bromoform is ranked as the least potent as a 

lethal acute oral toxicant. Toxic signs are reported relating to disruption of renal function. 
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5.2 Effects on skin and eye 

5.2.1 Ozone: based on applicant’s submitted information (EHS, 1990), ozone seems not to 

cause any adverse effect on the skin but is irritating to the eyes when exposed to 4mg/L (2ppm) 

for several minutes; other information (CCOHS) refers that ozone gas can probably cause skin 

irritation due to its oxidizing ability, but only at concentrations capable of causing severe 

respiratory injury. 

5.2.2 A summary of the skin and eye irritancy potential of ozone and bromate ions is shown in 

the following table: 

Ozone 

 Observation Species Reference/Comments 

Skin Not irritant EHP (1990) 

Eyes Irritant (>0.04mg/L for 

several minutes) 

Human EHP (1990) 

Bromate 

Skin Irritant Human RTECS 

Eyes Irritant Human RTECS 

5.3 Irritation to the respiratory tract 

The Group noted that inhalation exposure to ozone causes coughing and/or breathing difficulties 

at 0.03μg/L to 1.2μg/L (0.015-0.6 ppm) (information retrieved from MSDS). 

5.4 Repeated dose toxicity 

5.4.1 Ozone: from the available information, it was not possible to address the dose-response 

effects in relation to repeated inhalation exposure (sub-chronic, 90 days) to ozone. However, the 

Group may predict similar effects on the lungs of humans and other mammals even at low 

concentrations. In addition, it is referred in literature that the severity of respiratory responses 

seem to be reduced following repeated daily exposures due to an apparently “functional 

adaptation”. 

5.4.2 Bromate: it was noted that the exposure of rats to bromate for 15 weeks demonstrated a 

No Observed Adverse Effect Level (NOAEL) of 30 mg/kg bw/day. One study via oral route, 

made with F344 rats, for 13 weeks, showed, at a dose of 63 mg/kg bw/day, adverse effects with 

significant increases in blood serum parameters indicative of liver and kidney toxicity (including 

glutamate oxaloacetate transaminase, lactate dehydrogenase, cholinesterase and blood urea 

nitrogen). 

5.4.3 Bromoform: a 13-week study was performed in rats where a NOAEL of 

25mg/kg bw/day could be derived on the basis of the absence of liver lesions whereas in the 

study in mice was 100mg/kg bw/day (NTP, 1989). 

5.5 Chronic and long-term toxicity 

5.5.1 Ozone: in a series of well conducted studies, mice and rats exposed to 

0.01-0.02mg/kg bw/day for 105 to 130 weeks had increased incidence of non-carcinogenic 

lesions of the nose and lungs (NTP,1994). Several studies also examined the effects of the longterm effects on monkeys. Exposures ranging from 0.003-0.013mg/kg bw/day for 3-18 months 
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consistently showed significant structural alterations to lungs. Many of them seem to be 

irreversible six months after exposure stopped (COSHH). 

5.5.2 Studies in humans examining the potential effects of long-term occupational exposures to 

ozone have reported headaches, irritation to nose and throat, chest constriction and lung 

congestion in exposed workers. These studies suggest that long-term exposures to ozone may 

result in impaired lung function which is consistent to animal studies results. 

5.5.3 Bromate: the systemic toxicity of bromate (administered as potassium salt) has been 

reported from long-term studies designed to evaluate bromate carcinogenicity in F344 rats and 

B6C3F1 mice (WHO, 2005). The data show that the kidney is the major target organ of 

bromate-associated toxicity and that rats are more sensitive than mice to bromate treatment. 

5.5.4 Following 15 months’ exposure to 30mg/kg bw/day of bromate in drinking water, 

changes to the kidneys of the exposed rats were observed along with increased blood urea 

nitrogen and structural abnormalities of the cortical tubules. From these observations, NOAEL 

could not be determined but a LOAEL of 30mg of bromate/kg bw/day had been identified as part 

of the study. 

5.5.5 Bromoform was studied in a 2-year study with rats resulting in a small increase in 

tumours of the large intestine, at dose of 200mg/kg bw/day. 

5.6 Mutagenicity/Genotoxicity 

5.6.1 Ozone: there are a number of studies in literature to examine the potential for 

mutagenicity of ozone in humans but due to some deficiencies not all of them seem to be 

conclusive. 

5.6.2 However, the Group noted that positive results (cytogenetic aberrations) were observed in 

the lymphocytes of hamsters exposed to 0.0048-0.086mg/kg bw for 5 hours and in the lung 

macrophages of female rats exposed to 0.0024-0.016mg/kg bw for 6 hours. However, several 

studies have shown that ozone is mutagenic in bacteria and in mammalian and human cells 

in vitro following inhalation exposure (NTP, 1994; Mutation Research, 1992). 

5.6.3 Bromate: in particular potassium bromate, is considered mutagenic both in vitro and 

in vivo. In fact, positive results were obtained in bacteria test (Ames test), chromosome 

aberrations in cultured Chinese hamster fibroblast cells, acute cytogenetic effects on rat bone 

marrow cells and in the mouse micronucleus test. 

5.6.4 Bromoform: bromoform is largely positive in bacterial assays of mutagenicity and 

appeared to be more potent than the other brominated THMs. In vivo studies have given 

contradictory results. 

5.6.5 From the available information, the Group concluded that there may be a concern towards 

the mutagenicity/genotoxicity potential of ozone following inhalation exposure and towards 

subsequent brominated by-products, in particular potassium bromate, following oral exposure. 
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5.7 Developmental and reproductive toxicity 

5.7.1 Ozone: a study reported offspring of rats continuously exposed to 0.02 or 0.03mg/kg bw 

for four days during middle or late pregnancy had reduced growth rates after birth and delayed 

behavioural development. Maternal toxicity was not reported. 

5.7.2 Another study reported a decrease in foetal body weight gain in the offspring of mice 

exposed to 0.024 but not to 0.008 or 0.016mg/kg bw, on days 7-17 of pregnancy. Signs of 

maternal toxicity were observed (Tox. Applied Pharmac.,1979). 

5.7.3 Embryotoxicity (increased resorptions) was observed in rats exposed to 0.03 and 

0.04mg/kg bw, but not 0.013-0.025mg/kg bw. Maternal toxicity was not reported (COSHH). 

5.7.4 Continuous exposure of mice from six days prior to mating to postnatal day 22 resulted in 

reduced body weight and slight effects in neurobehaviour development of the offspring. 

Maternal toxicity was not evaluated (Arch.Toxicology, 1995). 

5.7.5 No effects on reproductive performance (proportion of successful pregnancies, litter size, 

offspring viability and sex ratio) were noted in mice exposed for six days prior to mating to 

postnatal day 22 (dose was not referred) (Arch.Toxicology, 1995). 

5.7.6 Bromate: no effects on reproductive performance had been observed in a study made 

with rats and mice fed with 15mg potassium bromate per kg body weight over five and eight 

generations, respectively. Based on the test results, the Group concluded that bromate does not 

indicate to have developmental or reproductive toxicity. 

5.7.7 Bromoform: Ruddick et al. (1983) conducted a teratological investigation in 

Sprague-Dawley rats, where bromoform was administered by gavage at dose of 50, 100 or 

200mg/kg bw/day on gestation days 6-15. Evidence of foetotoxic response was observed, but 

there were no foetal malformations. This study was used to examine effects on fertility and 

reproduction in Swiss CD-1 female rats. There were no detectable effects of bromoform on 

reproduction function. Bromoform was found to induce resorption in F344 pregnant rats, at 

higher doses (150 and 200mg/kg bw/day). 

5.8 Carcinogenicity 

5.8.1 Ozone: no data were submitted by the applicant for the carcinogenicity potential 

assessment of ozone. From a study with rats and mice exposed to 0.0024, 0.01 and 

0.02mg/kg bw of ozone for 105 to 130 weeks, there was no evidence for carcinogenicity in male 

and female rats, inconclusive evidence in male mice, and some evidence in female mice. Ozone 

did not have tumour promoter properties (NTP, 1994). 

5.8.2 No human carcinogenicity information related to ozone exposure was available. The 

American Conference of Governmental Industrial Hygienists (ACGIH) has designated this 

chemical as not classifiable as a human carcinogen (A4). 

 

5.8.3 Bromate: is an active oxidant in biological systems and has been shown to cause an 

increase in renal tumours, peritoneal mesotheliomas and thyroid follicular cell tumours in rats, 

and to a lesser extent in hamsters and mice. The lowest dose at which an increased incidence of 

renal tumours was observed in rats was 6mg/kg bw/day. 
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5.8.4 A clear dose-response relationship has been observed in tumour incidence and the 

severity/progression of tumours. The weight of evidence clearly indicates that bromate has the 

potential to be human carcinogen. 

5.8.5 IARC classified it in Group 2B (possible human carcinogen). 

5.8.6 Bromoform: IARC has evaluated carcinogenicity of bromoform and concluded that there 

is inadequate evidence for its carcinogenicity in humans and limited evidence for its 

carcinogenicity in experimental animals. IARC classified Bromoform in Group 3 (not 

classifiable as to its carcinogenic potential to humans). 

5.9 Toxicokinetics 

5.9.1 Ozone: is absorbed in both the upper and lower respiratory tract. It is a potent oxidant that 

reacts with protein and lipids, particularly within biological membranes. A small amount of 

inhaled ozone is absorbed into the blood. The extreme reactivity of ozone limits its ability to 

accumulate. 

5.9.2 Bromate: following from oral administration, bromate is rapidly absorbed from the GIT. 

It was not detected in rat tissues following intragastric dose, but was significantly increased in 

plasma, red blood cells, pancreas, kidneys, stomach, and small intestine. 

5.9.3 Bromate may be converted into hypobromic acid by hypochloric acid in the stomach. 

Liver and kidney tissues may degrade bromate to bromide by a process involving glutathione, 

although only small amounts appear to be reduced in this way. Bromate is excreted mainly by 

urine as bromate and bromide; some may also be eliminated by faeces. Bromate concentrations 

in urine peak at about 1h, and bromate is not detectable in plasma after 2h. 

 

5.9.4 Bromoform: toxikocinetic information was not found by the Group however some 

considerations can be draw. Although bromoform appear to have greater propensity for 

metabolism, it appears to be less potent toxicant and carcinogen based on the NTP (1985,1987) 

bioassays and numerous in vivo toxicity studies. A possible explanation is less bioavailability 

resulting from the greater lipophilicity of this compound (logPow~240) which, together with 

greater reactivity of bromoform metabolites, may also prevent it from reaching critical target 

sites. 

5.9.5 Bromoform: Limited data indicate that bromoform is rapidly and efficiently taken up by 

the Gastro Intestinal Tract (GIT) but further studies to confirm and refine estimates would be 

valuable. No toxicokinetic data exist for inhalation exposure and dermal absorption. Of 

particular interest would be studies that seek to clarify the role of metabolism in toxicity, the 

mechanism by which metabolites and adducts lead to toxic effects, and the protective 

mechanisms such as cellular antioxidants. Available toxicity data indicate that target tissues are 

similar in humans, rats and mice. Limited data suggest that effect levels are generally similar 

across species (US Department of Health and Human Services, 2005). 

5.9.6 Although bromoform has greater propensity for metabolism, it appears to be less potent 

toxicant and carcinogen than other brominated THM based on the NTP (1985,1987) bioassays 

and numerous in vivo toxicity studies. A possible explanation is the less bioavailability resulting 

from the greater lipophilicity of this compound (logPow~240) which associated to greater 

reactivity of bromoform metabolites, may prevent it from reaching critical target sites.
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5.10 Conclusions from Human Health Hazard Assessment: 

5.10.1 From the human health effects assessment and taking into consideration the substances at 

the effective concentrations in the disinfection process described in the republic of Korea’s 

Application Dossier, the Group was able to reach the following conclusions: 

5.10.2 Ozone: very toxic by inhalation route and therefore highly recommendable to apply strict 

mitigation measures to avoid human inhalation exposure during the process. In addition, by oral 

exposure and due to its oxidant properties, there may be a concern towards ozone potential for 

mutagenicity. 

5.10.3 Bromate (potassium bromate): several studies indicate high potential for 

mutagenicity/carcinogenicity in humans. The current MCL (Maximum Contaminant Level) in 

the United States is 0.010mg/L and the maximum contaminant level goal is zero, because of the 

possibility that bromate may function as a genotoxic carcinogen. Therefore the exposure should 

be totally avoided. 

5.10.4 Bromoform and other brominated DBP: as highly reactive compounds capable of 

bioaccumulating, exposure to these on the long-term should be minimized. 

5.10.5 Other relevant factors which have to be taken into account when assessing human 

exposure towards chemicals: 

 .1 the variability in individual sensitivity; and 

 .2 the fact that complex mixtures of disinfectants and DBPs, according to the actual 

knowledge, interact in an additive way, at low concentration. Therefore, the 

Group raised an additional concern about the potential for cumulative 

toxicological effects of the mixture of chemicals generated by the system proposed 

by the Korean Application 

6 RISKS TO SAFETY OF SHIP AND CREW 

6.1 The Group noted that the dossier provided generic safety requirements required for an 

ozone system. However, no indication was given on how these requirements are to be applied 

when such a system is used onboard a ship. Therefore a quantitative assessment of the risks with 

such an application and use of ozone was unobtainable. 

6.2 The proposal indicates that the production of the carcinogenic Brominated 

Trihalomethanes (THM’s) may be significant but no risk mitigation measures have been 

proposed. 

6.3 An indication of the corrosive properties that may be associated with high oxidising 

agents and a potential assessment of the corrosive effect that may be experienced in the ballast 

tank was provided. However, there appeared to be no consideration of corrosion problems that 

may be anticipated in ballast water piping as a result of installation of such a system. 
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7 ENVIRONMENTAL FATE AND EXPOSURE 

7.1 Environmental fate and behaviour properties 

7.1.1 Table T7.1 gives an overview of the data available for different processes occurring in the 

environment. 

Table T7.1 Overview of fate processes for ozone, bromate ion and bromoform. 

Property Ozone Bromate ion Bromoform 

Hydrolysis 

pH5 (seawater) ≤5 sec 

pH7 (seawater) ≤5 sec 

pH9 (seawater) ≤5 sec 

Photolysis 

Degradation in seawater 

Ready biodegradation 1 h 

Biodegradation W: 38 d 

S: 75 d 

Sed: 340 d 

A: 380 d 

Sorption (Koc) 2.06 

Bioconcentration 14 

Anaerobic degradation 

7.1.2 It was noted that: 

 .1 bromoform is stable in water; 

 .2 no information was available the oxidation or photolysis of bromoform in water; 

and 

 .3 only limited biodegradation had been observed for bromoform. 

7.2 Fate in ballast water tanks 

7.2.1 As stated in the application dossier the formation of the Active Substance is described 

with the following reaction equations: 

O3 + Br-

 O2 + OBr- k = 160 ± 20 M-1s

-1

O2 + OBr- 2O2 + Br- k = 330 ± 60 M-1s

-1

OBr- + H3O+ HOBr + H2O k = 2.09 109 M-1s

-1

HOBr + H2O OBr- + H3O+ pKa = 8.8 ~ 9.0 

2O3 +OBr-

 2O2 + BrO3

-

 k = 100 ± 20 M-1s

-1

HOBr + NH3 NH2Br + H2O k = 7.5 107

 M-1s

-1 

where O3 and OBr-

 are considered the real actives and k is the reaction rate constant. 

In the Figure F1 these main reactions of the chemistry of ozone are depicted. 
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Figure F1 Main reaction scheme for ozone. 

7.2.2 The Group noted that, as no information had been provided on the dose of ozone during 

the application to ballast water it was not possible to give an estimation of the concentration 

levels of ozone and the Relevant Chemicals in the environment. Further inquiry revealed that a 

normal operation procedure would result in a concentration of about 1 mg O3/L. The maximum 

concentration of O3 would be 1.7 mg O3/L ballast water. It should however be noted that this 

concentration is applied to the ballast water before performing its disinfecting activity. However, 

the applicant indicated that the concentration of Ozone released from the tank would be close to 

zero. 

7.2.3 The group concluded that the main components to take into account for the risk 

assessment would be bromate (as TRO) and bromoform. Further considerations are therefore 

focussed on these two chemicals. 

7.3 Fate in the environment 

 Bioaccumulation (B) 

Test Substance Log Pow BCF B 

(Yes/No) 

Ozone Missing (<1) Missing Missing (No) 

TRO Missing Missing Missing 

Bromate ion Missing Missing Missing 

Bromoform 2.40 (EPI Suite) 14 No 

7.4 Environmental exposure 

7.4.1 The Group noted that the applicant had not provided any information on the 

environmental exposure risks of the Active Substance or Relevant Chemicals. 
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8 ENVIRONMENTAL EFFECTS 

8.1 Aquatic toxicity of Active Substance/Preparation/Relevant Chemicals 

Acute aquatic toxicity data in fish, crustaceans, algae and other organisms. The data on the acute 

toxicity of the Active Substance and the Relevant Chemical is shown in Table T8.1. 

Table T8.1 Overview of acute toxicity data. 

Test 

Substance 

F 

C 

A 

Species Effect Value 

F Morone americana 96-h LC50 0.20 mg/L as TRO 

Ozone C Daphnia magna 48-h LC50 0.011 mg/L 

A Nannochloris sp. 72-h EbgCx <0.45 mg/L as TRO 

F Morone saxatilis 96-h LC50 0.08 mg/L as TRO 

C Crab 48-h LC50 0.08 mg/L as TRO 

Total 

Residual 

Oxidant 

(TRO) 

A Skeletonema costatum 24-h EbgCx <0.1 mg/L as TRO 

F Oncorhynchus keta 96-h LC50 512 mg/L 

C Crassostrea gigas 48-h EC50 30 mg/L Bromate 

ion A Missing 

F Cyprinodon variegates 96-h LC50 7.1 mg/L 

Bromoform C Americamysis bahia 96-h LC50 24.4 mg/L 

A Skeletonema costatum 168-h IC50 32 mg/L 

 F = Fish, C = Crustacea, A = Algae 

8.1.2 Based on these data the 96-h LC50 = 0.08 mg/L as TRO is selected as the value to take 

into account in the further considerations on the risk assessment. For bromate the 48-h EC50 = 

30 mg/L will be used and for bromoform the 96-h LC50 = 7.1 mg/L. 

8.1.3 No data waivers were considered necessary as all the required data had been provided. 

8.2 Chronic Aquatic toxicity of Active Substance/Preparation/Relevant Chemicals 

8.2.1 The only data provided on the chronic toxicity of one of the Relevant Chemicals are 

shown in table T8.2. 

Table T8.2 Overview of chronic toxicity data. 

Test 

Substance 

F 

C 

A 

Species Effect Value 

F Cyprinodon variegates 28-d NOEC 4.8 mg/L 

Bromoform C 

A 
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8.2.2 The only value available for deriving a chronic PNEC for bromoform is therefore 

28-d NOEC = 4.8 mg/L for the species Cyprinodon variegates. This value was used in the 

further considerations on the risk assessment. 

8.3 Derivation of a Predicted No Effect Concentration (PNEC) 

8.3.1 TRO: As for TRO only acute toxicity data are available the PNEC will be derived by an 

assessment factor of 1000 on the lowest value: PNEC = 0.08 μg/L as TRO. 

8.3.2 Bromate: As there appeared to be a discrepancy between the data submitted by this 

applicant and that submitted by another applicant, the Group decided to use those values 

calculated for the Japanese submission. 

8.3.3 Bromoform: As for bromoform there is one chronic value available. An assessment 

factor of 100 is applied to this value resulting in a PNECchronic = 48 μg/L and 3 acute data, the 

lowest of which is 7.1 mg/L. Using an assessment factor of 1000 the PNECacute is established at 

7.1 μg/L. Of these two data the lowest value is taken as the resulting PNEC: PNEC = 7.1 μg/L as 

bromoform. 

9 ENVIRONMENTAL RISK CHARACTERIZATION 

9.1 PBT Assessment 

9.1.1 Three products were identified as being relevant to assess for their Persistence (P), 

Bioaccumulation potential (B) and their Toxicity (T). The assessment of these products is shown 

below: 

Compound Persistence (P) 

1⁄2 Life: 

>60d in seawater 

>40d in freshwater 

>180d in sea sediment 

>120d in fw sediment 

Bioaccumulation (B) 

Log Pow >3 

Toxicity (T) 

Chronic NOEC<0.01 mg/L 

Ozone No No 

Bromate ion No 

Bromoform Yes No No 

9.1.2 The Group agreed that, although no information was available on the B-characteristics of 

ozone and bromate ion it was not expected that any of these substances would meet the criteria 

and should be classified as a PBT substance. 

9.2 Assessment of treated ballast water 

9.2.1 The Group noted that experiments to determine the concentrations of Active Substances 

(Ozone) and Relevant Chemicals (Bromate ions and Bromoform) yielded the following results: 
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Concentration 

(mg/L) 

Ozone 1.36 at time zero 

Total Residual Oxidant (TRO) 5.0 

Bromate ion <0.002 (Detection Limit) 

Bromoform 0.136 (max. observed) 

9.2.2 From these data the group concludes that the maximum concentration relevant for the 

environment would be TRO and bromoform. The concentration for TRO of 5 mg/L and for 

bromoform 0.136 mg/L would be relevant to take into account for further exposure of the aquatic 

environment. 

9.3 Environmental risk assessment 

9.3.1 The Group noted that the half-life for ozone in seawater was reported as only 5.8s and so 

would be degraded prior to being released into the marine environment. 

9.3.2 The Group agreed that as the applicant had not provided any information on the 

Predicted Environmental Concentrations (PECs), it was not possible to carry out a proper 

Risk Assessment.

10 CONCLUSIONS AND RECOMMENDATIONS 

10.1 Due to missing basic information about the components of the BWMS which were not 

included in the dossier such as: 

 .1 an overview of the ballast water management system (BWMS) with description of 

the components of the system; 

 .2 an overview of how the BWMS may be integrated to the ships ballast water 

system and how control of the system is to be effected; 

 .3 how ozone will be injected into the ballast water pipe; 

 .4 safety considerations regarding the presence of free ozone in the ballast tanks; and 

 .5 a full consideration of the corrosive implications arising from the use of ozone. 

the Group was not able to carry out a proper evaluation of the hazards or a meaningful Risk 

Assessment of the system. 

10.2 The Group agreed that the risk to the environment related to the presence of TRO and 

bromoform should be further assessed. 

10.3 The Group recognized that the exposure to the Active Substance ozone is very limited as 

the substance will react with organic matter and therefore degrades rapidly. On the other hand 

the formation of bromate and bromoform as a Relevant Chemical are of serious human and 

environmental concern. Possibly remaining total residual oxidant (TRO) will still be present in 

concentrations that may cause concern. 
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10.4 With respect to the environment, the application of ozone as an Active Substance results 

in a concern for the release of total residual oxidant (TRO) and bromoform. Further elaboration 

on the risks established by additional data may reduce these risks. 

10.5 Taking all conclusions together the Group did not recommend giving Basic Approval for 

the NK Ballast Water Treatment System submitted by Republic of Korea as there are too many 

questionable topics that remain unanswered. 

*** 
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ANNEX 7 

REVIEW OF PROPOSAL FOR THE APPROVAL OF ACTIVE SUBSTANCES 

EctoSysTM which generates hydroxyl radicals, free active chlorine and hydrogen 

Submitted by Sweden 

0 SUMMARY 

0.1 The Group noted that the proposed system is an electrochemical device which oxidises 

microorganisms and other contaminants on the electrode surface. As such, chemicals are neither 

required to be stored onboard nor generated on demand. However, it was noted that Hydroxyl 

radicals, Free Active Chlorine and Hydrogen are produced as by-products and should be regarded 

as Active Substances and Relevant Chemicals. 

0.2 Whilst the applicant indicated that no other harmful substances, such as trihalomethanes, 

are formed, the Group noted that this was only on small scale tests and so requested further 

information once the scale of such tests are increased. 

0.3 The Group agreed that the health effects of the Active Substances/Relevant Chemicals are 

primarily due to acute exposure though some concerns are also addressed in literature related to 

toxicity to respiratory and developmental/reproductive function and carcinogenicity, depending 

on the severity of exposure and presumably under long term exposures (e.g., occupational 

scenarios). As a result, the Group proposed that this aspect should be investigated further. 

0.4 Whilst noting that the applicant had indicated that the levels of hydrogen and oxygen 

which are formed during the treatment process do not reach hazardous concentrations, concern 

was expressed that this might not necessarily be the case under all circumstances as the 

associated safety factor was only x2 and it was thought that this might not be enough. As a 

result, it was proposed that this aspect be investigated further under all possible conditions. 

0.5 Whilst recognizing that the short-term corrosivity experiments indicated that the treated 

ballast water was not corrosive to the materials of construction, the Group welcomed the fact that 

the applicant is to carry out further long-term studies in this area. 

0.6 Whilst recognizing the difficulties involved, the Group noted that the chemical 

composition of the ballast water treated with the EctoSys system. Furthermore, the Group agreed 

that most of those identified were degradable. However, it was proposed that further 

investigations should be undertaken with halogenated organics to show whether or not they could 

be excluded from the Risk Assessment. 

0.7 As the treated ballast water showed signs of relatively high toxicity, the Group 

recommended that ballast water treated with the EctoSys system would required a relatively high 

dilution immediately after discharge into the environment in order to avoid acute toxic effects. 

0.8 Taking all factors into account, the Group recommended that Basic Approval is given to 

the Ectosys system in order to allow further investigation and development to take place. 

However, the Group stressed that, at this stage, it was not possible to judge whether the system 

would be suitable for recommending Final Approval. 
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1 INTRODUCTION 

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

MEPC (MEPC 55/2/4) and the application dossier. 

2 COMPLETENESS OF DOSSIER 

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

the GESAMP BWWG: 

 .1 Application Dossier 

 .2 Summary (MEPC 55/2/4) 

2.2 The Group noted that an Assessment Report had not been submitted as part of the 

Application Dossier, but that the Summary, as submitted to MEPC 55, was so detailed that no 

separate Assessment Report was considered necessary. 

2.3 The Group further noted that the BWMS was designed for in situ generation of very 

short-lived active species in the ballast water including hydroxyl radicals and chlorine gas. Due 

to the short half-life of these species, no data for these species were included in the Application 

Dossier. Further reaction products include free active chlorine and information on various 

chlorine compounds had been included in the dossier. Thus, the Group considered the 

Application Dossier to be complete. 

3 DESCRIPTION OF BWMS 

3.1 The Group noted that the applicant indicated that the EctoSysTM system is an 

electrochemical system utilizing electrodes with high oxygen overpotential producing powerful 

disinfectants such as the hydroxyl radical directly into the ballast water, causing oxidation of 

microorganisms and other contaminants on the electrode surface. It was further stated that small 

amounts of harmless disinfecting by-products (i.e., free active chlorine) are produced that prevent 

regrowth of species in the tank. Individual modules can be dimensioned for treatment flow rates 

up to 500m3

/h. It was also noted that the applicant indicated an intention for the ballast water to 

be typically treated during both its uptake and discharge. 

3.2 It was also noted that the submission indicated that the EctoSysTM system generates the 

Active Substances in situ and so there are no products to be transported or generated onboard 

prior to injection into the ballast water. 

3.1 Application 

3.1.1 The Group noted that the application had indicated that the EctoSysTM is used for ballast 

water treatment as the disinfecting step following a mechanical separation of contaminants down 

to 40-45μm scale. The submission stated that the EctoSysTM comprises an electrochemical cell 

fitted directly in the ballast water line utilising catalytically inactive electrodes that produce 

highly oxidative species without the problems associated with conventional chlorine electrolysis. 
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3.1.2 Furthermore, it was noted that the only process control referred to in the application was 

“a number of automatic safety clamping devices that will shut the system off if an external 

emergency (such as for instance pump failure causing decreased flow rates) occurs”. There was 

no indication of the use of system sensors to monitor the rate of production of the reaction 

products or control the applied current and so take into account variances in salinity. It was also 

noted that the application stated that the system is designed for purification and disinfection in 

high flow applications with conductive media such as natural sea water or brackish water, the 

effect of system in fresh water was not clarified. 

3.1.3 The Group further noted that the application data provided was mainly based on 

small-scale pilot equipments and that there was indication of possible scaling-up problems that 

are to be thoroughly investigated and reported during the future test phases. It was agreed that a 

full assessment and verification of the acceptability of actual system data will be necessary prior 

to granting a Final Approval to the system. 

3.2 Active Substance(s) and Relevant Chemical(s) 

3.2.1 It was noted that the submission stated that it is not possible to make a complete account 

of all chemical species formed in the reactor, but that the following easily identified Active 

Substances and Relevant Chemicals can be produced in detectable concentrations by the small 

scale system tested prior to the application for basic approval: 

 .1 Hydroxyl radicals OH·; 

 .2 Free Active Chlorine which includes the following: 

 .2.1 Chlorine gas: Cl2, 

 .2.2 HOCl and ClO-

 which react to form sodium hypochlorite at levels of 

0.05 - 2 ppm amongst others 

 .2.3 As the Free Active Chlorine reacts with a range of naturally occurring 

chemicals it is also referred to as Total Residual Oxidants (TRO); and 

 .3 Hydrogen gas H2(g). 

3.2.2 The dossier states that no harmful substances such as trihalomethanes (THM) or 

Absorbable Organic Halogens (AOX) are formed because of cell design and electrode 

configuration. Table 7 at page 36 in MEPC 55/2/4 presents results of analysis performed as 

documentation for this statement. The Group noted, however, that these tests are only with small 

scale systems and that other available documentation about electrolysis of seawater includes 

other chemicals that may be formed such as bromate and bromoform. The Group, therefore, 

recommended that identification of possible Relevant Chemicals should be included in the 

further assessment of the method together with analysis of these in treated ballast water. 

3.2.3 The Group notes further that there is no information in the applicant dossier about Active 

Substances formed when applying the ballast water treatment system in fresh water. 

4 PHYSICOCHEMICAL PROPERTIES 

4.1 Physicochemical properties of Relevant Chemicals formed during application of the 

proposed system in ballast water are presented in the table below. 
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Physical property Hydroxyl 

radical 

Sodium 

hypochlorite Hydrogen Bromoform

CAS number 3352-57-6 7681-52-9 01333-74-0 75-25-2 

Molecular weight 17.01 74.4 2 252.7 

Melting point (°C) -20 to -30 -259°C 8.3°C 

Boiling point (°C) 96-120 -253 150° C 

Flash point (°C) 

Density (20°C) 

Vapour pressure @ 20°C (Pa) 

Vapour density 

(air=1) 

Water solubility 29.3% 

pH in solution 

Dissociation constant(pKa) 3100mg/l (25°C) 

Oxidation reduction potential Strong oxidiser 

Corrosivity to Material 2.06 

Reactivity to container material 

Auto ignition temperature (°C) 

Explosive Properties Anhydrous form is 

very explosive 

Oxidizing properties 

Surface tension 

Viscosity 

Thermal stability and breakdown 

product 

Other physical and Chemical 

property 

Due to the 

short half-life 

(nanoseconds) 

it is not 

practical to 

measure the 

usual physical 

properties 

 

 All the above data were extracted from the manufacturers supporting information 

(Annex, p11-12) 

5 HUMAN HEALTH HAZARDS 

5.1 General observations 

5.1.1 It was noted that the disinfection system proposed by the Swedish application dossier 

involves an electrochemical system, EctoSysTM, which generates in practice an equilibrium 

solution of chemicals: free chlorine (sodium hypochlorite) and hydroxyl (OH) radicals. The 

Active Substances Cl2, HOCl, OCl-, and OH radicals are produced electrolytically in situ and 

have presumably a very short-life. Brominated DBPs (Disinfection By-Products) will result from 

the process and will have to be taken into account due to its potential toxicity. 

5.1.2 The Group performed a qualitative evaluation of the human health effects based on 

published data whenever there was lack of toxicological data submitted by the applicant. 

5.1.3 Most of the experimental chlorine toxicity data are found under the WHO drinking-water 

disinfectants and disinfectant by-products research program where evidence is normally 
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associated to chlorine administered in drinking-water. Although being aware that this exposure is 

not particularly relevant to exposures to chlorine or hypochlorite in the Ballast Water Treatment 

processes, the Group consider the data to substantiate the qualitative assessment. 

5.2 Acute toxicity 

5.2.1 Hydroxyl radicals: systemic toxicity of hydroxyl ions confounds with elevated blood 

pH. Normal pH of blood is 7.35. The alkalosis causes hyperactivity to the central nervous 

system with above pH 7.8, tetanus, extreme excitability. A short-term mechanism is the 

respiration compensation. A long-term mechanism is the renal compensation. 

5.2.2 Free active chlorine (NaClO-): irritation, pain, inflammation of mucoses. In severe 

cases causes ulceration and perforation of gastro intestinal tract. Mild irritation to corrosive 

injury by dermal route depending on the concentration. Vapours are not easily formed however 

with more concentrated solutions and high pH or if mixed with acids higher % of chlorine may 

be released causing mild to severe irritation of nose and throat. Lethal effects can also occur, 

derived from aspiration of sodium hypochlorite solution into the lungs. Health effects depend on 

concentration and pH of the solution. 

5.2.3 Chlorine: Irritant effects on mucoses and skin are reported. Acute inflammatory effects 

of chlorine gas towards the respiratory tract are also well reported because of its use as a 

chemical warfare agent during World War I (Das & Blanc, 1993). The acute effects seem to be 

reversible in 1-4 weeks after exposure. However, two reports suggest that chronic sequelae to 

acute exposure to chlorine gas may be more prevalent than previously appreciated 

(Moore & Sherman, 1991). The severity of the health effects will depend on concentration of 

chlorine and pH of the solution. 

5.3 Effects on skin and eye 

5.3.1 Hydroxyl radicals: no available data. 

5.3.2 Free active chlorine (NaClO-

): can cause mild skin irritation to corrosive injury 

depending on the duration of contact, concentration and pH of the solution. In a skin 

sensitization test, negative results have been obtained for 8% sodium hypochlorite solution. 

5.3.2.1 Mild eye irritation to corrosive injury depending on the concentration and pH of the 

solution and on the duration of contact, as well. If warmed at higher temperature can release 

significant amounts of gas which is a severe eye irritant. 

Free Active Chlorine (Sodium hypochlorite) 

No data provided (values assumed from EC Classification of >10%) 

Exposure Route Value Species Reference/comments 

Inhalation LC50 

(mg/l/4h) 

>20 Unspecified Not classified by acute toxicity 

(EC classification) 

Oral LD50 (mg/kg) >2000 Unspecified Not classified by acute toxicity 

(EC classification) 

Dermal LD50 (mg/kg) >2000 Unspecified Not classified by acute toxicity 

(EC classification) 
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5.3.3 Chlorine: acute inflammatory effects to exposed skin. Acute inflammatory effects 

towards cornea and conjunctiva. 

5.4 Irritation to the respiratory tract 

5.4.1 Hydroxyl radicals: no available data 

5.4.2 Free active chlorine (NaClO-

): sodium hypochlorite does not easily form vapours 

however in more concentrated solutions and at high pH, form mists that can cause mild to severe 

irritation of the nose and throat. 

Free active chlorine (NaClO-

) 

5.4.3 Chlorine: irritant effects by inhalation and acute inflammatory effects towards the 

respiratory tract. This is the major route of concern, as chlorine gas vapours are heavy and settle 

down in low areas. 

5.5 Repeated dose toxicity 

5.5.1 Hydroxyl radicals: no available data 

5.5.2 Free active chlorine (NaClO- ): the concentration required to produce irritation and 

decreased basal cell viability in the skin of guinea pigs after an application period of two weeks 

was 0.5% sodium hypochlorite (equivalent to 139mg/kg bw/day); 0.1% (equivalent to 

28mg/kg bw/day) resulted in no effect on basal cell viability relative to control animals 

(Cotter et al., 1985). 

5.5.2.1 Hasegawa et al. (1986) examined the effects of higher concentrations of sodium 

hypochlorite (0.025, 0.05, 0.1, 0.2 or 0.4%, equivalent to 7, 14, 28, 55 and 111mg/kg bw per day) 

administered in drinking-water to male and female F344 rats for 13 weeks. No evidence of 

treatment-related pathology was observed in this study. 

5.5.2.2 Several rodent studies with administered sodium hypochlorite in drinking-water have 

suggested immunological changes. Exon et al. (1987) examined immunotoxicological effects of 

sodium hypochlorite at 5, 15 or 30mg/litre (0.7, 2.1 or 4.2.mg/kg bw per day) in the drinking 

water of male Sprague-Dawley rats for nine weeks. The effects on macrophage activity suggest 

that some impairment does occur at relatively low levels of sodium hypochlorite although the 

significance of which is still unknown. Modification of macrophage function seems to be one of 

the most sensitive responses identified in studies of chlorine or hypochlorite in experimental 

animals (EHC 216, WHO, 2000). 

Free Active Chlorine (Sodium hypochlorite) 

No data provided (values assumed from EC Classification of >10%)

 Observation Species Reference/Comments 

Skin Corrosive after <4h 

exposure 

Unspecified Corrosive (EC Classification) 

Eyes Corrosive Unspecified Corrosive (EC Classification) 

Observation Species Reference/comments 

Respiratory 

irritation 

Corrosive Unspecified Corrosive (EC classification) 
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5.5.3 Chlorine: a study from Daniel et al. (1990a) evaluated the toxicity of chlorine prepared 

by bubbling chlorine gas into distilled water and adjusting pH to 9.4. The nominal 

concentrations of chlorine were approxim. 0, 3, 10, 16 or 21 mg/kg bw per day, administered as 

drinking-water to both male and female Sprague-Dawley rats (10 per sex per dose) for 90 days. 

5.5.3.1 No deaths occurred in any treatment group. A NOEL (No Observed Effect Level) of 

10 mg/kg bw per day was identified by the authors based on reduced body weight gain however 

this cannot be considered a true toxicological end-point as can be associated to a reduced 

palatability of the drinking-water. 

5.6 Chronic and long-term toxicity 

5.6.1 Hydroxyl radicals: no available data 

5.6.2 Free active chlorine (NaClO-): from the applicants report it was not possible to 

conclude if the substance is an occupational skin sensitizer; however, some sporadic cases are 

reported in literature. 

5.6.3 Chlorine: in a 2-year study, the National Toxicology Program (NTP, 1992) examined 

chlorine at 0, 70, 140 or 275 mg/litre in drinking-water of F344 rats and B6C3F1 mice. The only 

treatment-related non-tumour pathology was found to be a dilatation of renal tubules in male 

mice at the highest dose level (275 mg/litre). No non-neoplastic lesions were observed in either 

male or female rats. 

5.6.3.1 A NOAEL can be derived of approximately 15 mg/kg bw per day in the two-year studies 

in rats and mice. 

5.6.3.2 Chronic exposure to chlorine gas may cause dyspnea, palpitations, chest pain reactive, 

upper airways dysfunction syndrome. It is one of the most frequent causes of occupational 

asthma. 

5.6.3.3 Relevant evidence based on epidemiological studies with survivors from World War I, 

clearly indicated bronchitis and limited chest and diaphragmatic movement, even emphysema. 

Most studies suggested high incidences of acute respiratory disease and a lesser prevalence of 

chronic sequelae. 

5.7 Mutagenicity/Genotoxicity 

5.7.1 Hydroxyl radicals: no available data 

5.7.2 Free active chlorine (NaClO-

): 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. It is not clear to what extent 

this is influenced by the formation of mutagenic by-products as a result of reactions with 

components of the incubation media (Rosenkranz et al., 1976). 

5.7.3 Chlorine: no available data however, as a strong oxidizing agent, chlorine has 

presumably a potential for chromosomal aberrations, at cytotoxic doses. 
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5.8 Developmental and reproductive toxicity 

5.8.1 Hydroxyl radicals: no available data 

5.8.2 Free active chlorine (NaClO- ): some indicative effects of altered sperm shape have 

been detected in several studies with chlorinated drinking-water. Meier et al. (1985b) reported 

that oral administration of sodium hypochlorite (pH 8.5) prepared from chlorine gas and 

administered at 4 or 8 mg/kg bw per day for 5 weeks increased the incidence of sperm 

abnormalities in B6C3F1 mice. 

5.8.3 Chlorine: in general, animal studies have demonstrated no reproductive or teratogenic 

effects of chlorine (Druckrey, 1968). A number of subsequent studies have studied the effects of 

chlorine or hypochlorite however there is insufficient information to draw conclusions about the 

potential for developmental toxicity (EHC 216, WHO, 2000). 

5.9 Carcinogenicity 

5.9.1 Hydroxyl radicals: no available data. 

5.9.2 Free active chlorine (NaClO-

) in most animal studies there is a lack of statistical 

evaluation of the results and lack of dose-response relationship. Sodium hypochlorite is not 

classified by IARC as to their carcinogenicity to humans (Group 3). 

5.9.3 Chlorine: lymphoma has been observed in relation to water treatment with chlorine. 

Associations with increased renal, bladder and gastric cancers have been registered. 

5.10 Toxicokinetics 

5.10.1 Hydroxyl radicals: no available data. 

5.10.2 Free active chlorine (NaClO-

): it was shown that hypochlorite does not accumulate in 

the body, it reacts with tissues and apparently is readily absorbed in serum and eliminated from 

plasma with a half-life of 44 h. 

5.10.3 Chlorine: there are no specific toxicities of chlorine for which a mechanism needs to be 

proposed. It is a strong oxidizing agent, and it must be presumed that the toxicological mode of 

action induced at high doses by either gaseous chlorine or solutions of hypochlorite is at least 

partially related to this property. 

5.11 Conclusions from Human Health Hazard Assessment: 

5.11.1 From the above information it is concluded that the critical health effects resulting from 

human exposure to the active substances and relevant compounds existing in the solution are 

mostly acute in nature; however, some concerns are also addressed in literature related to toxicity 

to respiratory and developmental/reproductive function and carcinogenicity, depending on the 

severity of exposure and presumably under long term exposures (e.g., occupational scenarios). 

5.11.2 Other relevant factors have also to be taken into account when assessing human exposure 

towards chemicals include, inter alia: 

 .1 the variability in individual sensitivity; 
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 .2 the fact that complex mixtures of disinfectants and DBPs, according to the actual 

knowledge, interact in an additive way, at low concentration. 

5.11.3 Therefore, the Group raised an additional concern towards the potential for cumulative 

toxicological effects of the mixture of chemicals generated by EctoSysTM . 

5.11.4 Disinfectant By-Products (DBPs) – Trihalomethanes (THMs) 

5.11.4.1 THMs are expected to be the most prevalent by-products of disinfection by using 

chlorine. 

5.11.4.2 These compounds are volatile liquids at room temperature, therefore, as chemicals 

vaporize during water usage, inhalation becomes an important exposure route in addition to 

ingestion. 

5.11.4.3 According to experimental data (EHC 216, 2000), a variety of non-neoplastic 

toxic effects have been associated with short-term and long-term exposure of experimental 

animals to high doses of THMs, and each of the most common THMs – chloroform, BDCM 

(bromodichloromethane), DBCM (dibromochloromethane) and bromoform – has been shown to 

be carcinogenic to rodents in high-dose chronic studies. 

5.11.4.4 Chloroform is generally the predominant THM in chlorinated water and is also the 

most extensively studied chemical of this class as it has been used for clinical purposes for 

decades. Animal studies have indicated that chloroform can induce cancer only after chronic 

exposure to cytotoxic doses, therefore it seems clear that low exposures do not trigger these 

adverse effects. 

5.11.4.5 When bromine is present in the water (e.g., seawater), lipid solubility of the 

halomethanes is enhanced (and consequently, uptake into the tissues) and generally increases 

their chemical reactivity and the likelihood of biotransformation to a reactive intermediate. 

5.11.4.6 According to existing information (EPA 216, 2000), cancer following chronic 

exposure is the primary hazard of concern for brominated THMs.

6 RISKS TO SAFETY OF SHIP AND CREW 

6.1. The Group concurred with the submission which stated that there are no risks with 

handling chemicals which can be associated with the EctoSysTM ballast water treatment system as 

the Active Substances and Relevant Chemicals are produced in situ and therefore not handled. 

6.2 The Group noted that the dossier presented indicated that trihalomethanes (THMs) is 

produced as a secondary disinfection by-product, but that because of the low levels of chlorines 

that are formed (<2ppm) combined with the high pH of sea water THM levels are well below 

United States EPA drinking water standards. Other studies suggested that THM is formed from 

the breakdown of chlorine and organic matter and that THM generation increases with pH, time, 

temperature and the amount of organic matter present, and that levels above 1ppm residual 

chlorine can produce unacceptable levels. 
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6.3 Furthermore it was noted that both Hydrogen and Oxygen are formed during the 

electrolysis process. The applicant indicated that no harmful concentrations of hydrogen gas 

(4%) will build up in the ballast tanks or surrounding systems and that a reliable degassing 

system will also be included to the complete ballast water treatment system. 

6.4 In addition, it was noted that, as hydrogen gas is explosive, and as THMs have a potential 

for carcinogenicity, it should be confirmed that residual levels of these substances within the 

ballast tanks following the treatment process in large scale tests remain within acceptable limits 

for crew and ship safety. This was considered to be particularly relevant as there remains doubt 

about the reliability of scaling-up data in this application. It was agreed that it will be necessary 

to consider the positioning of any system degassing discharge vents very carefully. The Group 

suggested that the possibility of the presence of free chlorine gas in the ballast tank should also 

be restricted due to the acute irritant effects by inhalation. 

6.5 It was noted that the applicant had made initial short term studies into the corrosive 

properties of the treated ballast water that partly confirm the claim that there is no change 

following treatment and that long-term corrosion studies had commenced to verify this. The 

Group noted that other studies had determined that the presence of residual chlorine, even in 

small quantities, have the ability to degrade tank coatings and dramatically increase normal 

corrosion rates, the results of the long term corrosion studies, particularly the effect on system 

piping directly following the treatment plant and ships ballast tanks will be relevant. 

7 ENVIRONMENTAL FATE AND EXPOSURE 

7.1 Environmental fate and behaviour properties 

7.1.1 The Group noted that when seawater is electrolysed applying anodic oxidation utilizing 

electrodes with high oxygen overpotential, organisms are removed both by direct oxidation at the 

anode (not producing any Active Substances) and by forming oxidants in the seawater which 

indirectly oxidate organisms and other organic carbon in the ballast water. 

7.2 Fate in ballast water tanks 

7.2.1 The Group noted that the following reactions are formed when seawater (marine and 

brackish) is electrolysed by use of the method described: 

1. H2O → 1

/2O2 + 2H+ + 2e - 

2. H2O → •OH + H+

 + e -

3. •OH → 1/2O2 + H+ + e -

4. 3H2O → O3 + 6H+ + 6e -

5. 2Cl -→ Cl2 + 2e -

7.2.2 However, it was also noted that the applicant’s dossier also included information about 

other reactions as a result of secondary oxidation compounds (e.g., hydroxyl radicals or 

hypochlorite reacting with natural chemicals in seawater). Most of the results from analysis of 

e.g., THM and AOX documenting concentrations below detection limits except concentrations of 

bromoform at up to 0.07 mg/L. Thus, the Group recommended that more detailed information 

about these Relevant Chemicals is provided in the application for final approval. 
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7.2.3 Referring to comments above and information given in the applicant dossier the Group 

recommended that at least the following analysis are performed of the treated ballast water in the 

further land based and onboard testing and documented in the application for final approval: 

.1 Chloro- and bromo-organic compounds (including THM – Trihalomethane and 

AOX – Absorbable Organic Halogens); 

.2 A general toxicity analysis (aggregate acute and chronic toxicity); 

.3 Bromate formation. 

7.2.4 A number of analyses of free active chlorine, after the first treatment, in various samples 

treated with the EctoSysTM system had been carried out by use of the N,N-diethyl-p-phenylenediamine (DPD) method. In general, the concentrations of free active chlorine were below 

2 mg/L. The applicant considers that the free active chlorine should be interpreted as Total 

Residual Oxidants (TRO). 

7.2.5 In connection with testing of the aquatic toxicity of treated ballast water, the application 

of the EctoSysTM system with treatment at ballasting and deballasting was simulated and the 

concentrations of free and residual chlorine were measured by a DPD method. The 

concentrations varied considerably, but the majority of the measured concentrations were in the 

range of 1-4 mg/L. It was considered noteworthy that the concentrations, after the second 

treatment, in general were much higher than after the first treatment, which might be a result of a 

considerable reduction in the concentration of organics from the first to the second treatment as a 

result of the first treatment. The Group assumed that the free chlorine measured here should be 

interpreted as TRO. 

7.2.6 Thus, the Group considered that concentrations of TRO in treated ballast water might also 

reflect discharges of treated ballast water in real-life situations. However, a further evaluation of 

these measurements is not possible, but the Group would recommend that more specific chemical 

measurements are undertaken during the further development process. 

7.3 Fate in the environment 

7.3.1 The EctoSysTM treatment system is intended to be applied both at ballasting and 

deballasting which means that the Relevant Chemicals formed although to some extent 

transformed in the ballast water tank during voyage, they will be formed again at discharge of the 

ballast water. The same transformation processes as taking place in the ballast water prior to 

discharge will thus also take place after discharge. 
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7.3.2 An overview of degradation half-lives of Active Substances and Relevant Chemicals is 

presented in the table below: 

Substance Half-life Comment Reference 

Hydroxyl radical, OH· Nano-seconds 

Chloride gas, Cl2 

Hypochlorite, ClOand hypochlorous 

acid, HClO 

Weeks? Estimated EPI Suite 

Free active chlorine 

(TRO) 

< 1 hour Reduction to 

background level 

Bromoform Weeks-months? Estimated EPI Suite 

7.3.3 Information on octanol/water partition coefficients, when available, is provided in the 

table below. 

Substance Octanol/water 

partition coefficient 

(log Pow) 

Comment Reference 

Hydroxyl radical, OH· Not relevant 

Chloride gas, Cl2 

Hypochlorite, ClOand hypochlorous 

acid, HClO 

-3.42 Estimated EPI Suite 

Free active chlorine 

(TRO) 

 

Bromoform 2.4 Measured EPI Suite 

7.3.4 Although the Group considered that an octanol/water partition coefficient might not be 

the most appropriate indicator of a bioaccumulation potential of small inorganic compounds, it is 

the judgement of the Group that none of the reaction products formed possess properties that 

allow a significant bioaccumulation. 

7.4 Environmental exposure 

7.4.1 The Group noted that the applicant had developed a model for estimating dilution of 

ballast water discharged into a port. The model had been run for both a generic port scenario and 

for the port of Bremerhaven. 

7.4.2 Figures showing the results of running the model for two generic port scenarios of 

different sizes in terms of dilutions of the treated ballast water at various points in the ports are 

included in the Dossier. Results are also included showing the time from discharge to the 

(average?) concentration of the treated ballast water is so low that no acute toxic effects are 

expected. This is discussed further in section 9.3 below. 

7.4.3 The Group is not aware of information that can justify the choice of input values for 

setting up one or more realistic models. 
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8 ENVIRONMENTAL EFFECTS 

8.1 Aquatic toxicity of Active Substance/Preparation/Relevant Chemicals 

8.1.1 A large number of test results of acute aquatic toxicity of Relevant Chemicals to various 

species were included in the application Dossier and a few of these are summarised in the table 

below. 

Test 

Substance 

F 

C 

A 

Species Effect Value Reference/Comments 

F Leiostomus 

xanthurus LC50 0.09mg/L MEPC 55/2/4, Anx, p22 

& p26 

C Pandalus 

goniurus LC50 0.09mg/L MEPC 55/2/4, Anx, p23 

& p27 

A 11 

Phytoplankton 

species 

LC50

0.075 - 

0.33mg/L 

MEPC 55/2/4, Anx, p 25 

& p29 

Free Active 

Chlorine 

(Sodium 

hypochlorite) 

M Molluscs 48h EC50 0.26mg/L MEPC 55/2/4, Anx, p31 

F Lepomis 

macrochirus 96h LC50 29mg/L MEPC 55/2/4, Anx, p38 

C Daphnia magna 48h LC50 29mg/L MEPC 55/2/4, Anx p38 Bromoform 

A LC50 

8.1.2 The Group noted that acute aquatic toxicity of free active chlorine is typically seen at 

concentrations of approx. 0.1 mg/L. 

8.1.3 Information on aquatic toxicity after long-term exposure is shown below. 

Test 

Substance 

F 

C 

A 

Species Effect Value Reference/Comments 

F Menidia penensulae

eggs 28d NOEC 0.04mg/l Co. rep Anx p23 & p26 

C Crassostrea virginica & 

Rangia cuneata 15d NOEC 0.007mg/l Co. rep Anx p24 & p27 

Free Active 

Chlorine 

A Phytoplankton 21d effect 0.001mg/l Co. rep Anx p25 & p29 

8.2 Aquatic toxicity of treated ballast water 

8.2.1 Information on acute aquatic toxicity of treated ballast water is summarised in the table 

below. The test samples were prepared by treating seawater and a 50:50 mixture of seawater and 

fresh water by the EctoSysTM system, storing the treated sample for three days, and re-treating the 

sample before initiation of the tests. This approach was intended to simulate the intended 

application in practice. 
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Test 

Substance 

F 

C 

A 

Species Effect Value Reference/Comments 

F Turbot & 

Rainbow trout 24h LC50 5.5% MEPC 55/2/4 Anx, p41 

C Tisbe battagliai 48h LC50 5.5-14% MEPC 55/2/4 Anx, p42 

A 

Skeletonema 

costatum 

72 h EC50

3.6-9.2% 

(biomass) 

6.4-11% 

(growth rate) 

MEPC 55/2/4 Anx, p42 

Ballast 

Water 

(Whole 

effluent 

toxicity test) A 

Skeletonema 

costatum 

72h NOEC 

3.0% 

(both biomass 

and growth 

rate) 

MEPC 55/2/4 Anx, p42 

The value for treated ballast water shows dilution ratio by natural seawater or 50:50 natural 

seawater/freshwater. 

8.2.2 The applicant had indicated that there was no need to carry out chronic toxicity tests for 

the treated ballast water as the acute tests exposed the organisms to a higher concentration of 

treated ballast water for a longer time than would occur in practice. The Group noted that the 

NOEC obtained in the 72 hours growth test with algae should be considered as a chronic toxicity. 

8.2.3 The Group welcomed the testing of the aquatic toxicity of treated ballast water, but also 

noted that the fish toxicity tests had been carried out using a duration of exposure of 24 hours 

while the normal exposure duration for acute toxicity tests with fish is normally 96 hours. Thus, 

the toxicity may have been underestimated. 

8.2.4 The Group recognized that the toxicity had been tested with samples that had been 

retrieved immediately after a second treatment in accordance with the intended use of the system, 

and that after discharge and dilution in the environment the toxicity may be reduced as a result of 

transformation of the reactive species produced. However, no information is available on the rate 

with which the toxicity degrades after discharge. 

8.2.5 No internationally agreed approach for deriving a PNEC for complex samples has been 

developed, but the Danish EPA proposes that an assessment factor of 10 is used for deriving a 

short-term PNEC (PNECacute) when acute toxicity data are available for three aquatic species 

(Danish EPA 1995). For ballast water treated with the EctoSysTM system, a PNECacute = 0.4% 

equalling a dilution of approx. 250 times. 

9 ENVIRONMENTAL RISK CHARACTERIZATION 

9.1 PBT Assessment 

9.1.1 An indication of the compliance of the Relevant Chemicals with the PBT criteria is given 

in the table below. 
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Compound Persistence (P) Bioaccumulation 

(B)

Toxicity (T)

Hydroxyl radical, OH· No No ? 

Chloride gas, Cl2 No No ? 

Hypochlorite, ClO- and 

hypochlorous acid, HClO 

No No ? 

Free Active Chlorine No No Yes 

Bromoform Yes? No No? 

9.1.2 Based on the overview, the Group concludes that none of the Relevant Chemicals fulfil 

all of the three PBT criteria and consequently, none of the chemicals can be considered as 

PBT substances. 

9.2 Assessment of treated ballast water 

9.2.1 Concentrations of free and residual chlorine and TRO has been measured in treated 

ballast water at typical concentrations of 1-4 mg/L. Considering that the acute toxicity of 

hypochlorite representing free active chlorine (or TRO) has been measured at typical 

concentrations at around 0.1 mg/L, which would then correspond to a dilution of 10-40 times of 

the treated ballast water. 

9.2.2 Considering that the direct toxicity tests with the treated ballast water indeed showed an 

acute toxicity at 3.6-14% corresponding to dilutions at 7-28 times, the Group concluded that this 

corresponded well to the expected dilution required, if free active chlorine is the main cause of 

the aquatic toxicity. 

9.3 Environmental risk assessment 

9.3.1 The Group noted that the applicant had run models to determine the Predicted 

Environmental Concentration (PEC) of treated ballast water in closed and open harbours using 

reasonable discharge volumes and unreasonably high ones. The results were expressed in terms 

of the time taken to reach the No Observed Effect (NOEC) level at 3% of the treated ballast 

water as determined in acute toxicity tests. However, this NOEC level was applicable to only the 

four species representing three groups of organisms and, consequently, the Group would propose 

to apply an Assessment Factor of 10 to the lowest effect concentration derived in an acute 

toxicity test for deriving a short-term PNEC (PNECacute) 

9.3.2 The Group noted that a discharge rate at 5,000 m3

/h during 10 hours is a reasonable 

scenario for VLCC, and in this case, the applicant estimated that only after more than 500 hours 

were the treated ballast water diluted so much that no acute toxicity was expected. 

9.3.3 Furthermore, the Group noted that under the worst case scenario, the concentration of 

Free Active Chlorine in ballast water during treatment would be < 2 ppm (<2 mg/l) compared to 

the USA/EPA drinking water standard of 4 mg/l. 

9.3.4 Consequently, the Group was of the opinion that discharge of large volumes of ballast 

water treated with the EctoSysTM system might result in concentrations of treated ballast water in 

the receiving environment that might cause acute toxic effects to aquatic organisms. 
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10 CONCLUSIONS AND RECOMMENDATIONS 

10.1 Risks to safety of ships 

10.1.1 The Group noted that experiments carried out so far indicate that ballast water treated by 

the proposed system does not show any increase in corrosive properties to materials used in the 

hulls of ships. However, the Group noted that other studies had shown that the presence of 

residual chlorine could greatly increase corrosion rates. For this reason, the Group welcomed the 

intention to perform longer term studies and recommended that further consideration should be 

given to the results of these tests. 

10.2 Risks to crew 

10.2.1 The Group noted that any chemicals produced by the system would be produced in situ

and so there was no potential exposure from leaking delivery pipe work to the ballast water. 

10.2.2 It was also noted that hydrogen gas had been identified by the applicant as a Relevant 

Chemical and concern was expressed the gas might be produced in sufficient amounts to cause 

an explosion. However, it was noted that, in experiments carried out in a closed tank 

environment, the system produced a maximum of 2000 ppm of hydrogen compared to the 

4000 ppm needed for an ignitable mixture with oxygen. In addition, it was noted that the system 

was to include a degassing system which would further reduce this potential risk. 

10.2.3 Whilst recognizing that the generation of hydrogen by the system should not cause a 

safety problem, the results of the tests currently being performed should be taken into account, 

particularly as the safety margin (x2) was not that great. 

10.2.4 Notwithstanding this observation, the Group agreed that the only potential exposure of the 

crew to the Active Substances might be via leaking pipe work in the pump room but the levels of 

Free Active Chlorine should not present a safety hazard to the crew. 

10.3 Risks to the environment 

10.3.1 The Group noted that the characterisation of the chemical composition of ballast water 

treated with the EctoSysTM system is far from complete. However, most of the individual 

components identified were considered to be degradable in the aquatic environment, although 

formation of halogenated organics as, e.g., bromoform cannot be excluded. 

10.3.2 The Group is also aware of that the EctoSysTM system is designed to treat ballast water 

both at ballasting and deballasting in order to be sufficiently effective. In particular the treatment 

of ballast water at discharge that has already been treated seems to result in formation of relative 

high concentrations of TRO, which might be the main reason for a relatively high initial toxicity 

of the treated ballast water requiring an initial dilution of up to 250 times in order to avoid acute 

toxic effects to the aquatic ecosystem. 

10.3.3 The Group notes that the measured acute toxicity of treated ballast water is found at a 

dilution that corresponds to the dilution required if the content of free active chlorine is the main 

component responsible for the toxicity. 
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10.4 Recommendations 

10.4.1 Having considered the available information the Group recommends that Basic Approval 

is given to this proposal. The Group also recommends that Basic Approval should be limited to 

further prototype development and type approval testing only. 

10.4.2 Furthermore, the Group recommends that the following conditions should apply during 

the further development and testing of the proposed system: 

 .1 discharge of ballast water treated with the EctoSysTM system should only take 

place under controlled conditions and into an environment where a sufficient 

dilution can be assured for avoiding acute aquatic toxicity; 

 .2 degradation of the toxicity of the treated ballast water should be studied, in 

particular during the initial period after discharge; 

 .3 further analyses of the content of reactive and potentially toxic species should be 

provided, in particular the possible formation of halogenated organics; 

 .4 it might be worthwhile to explore possibilities to fine-tune the EctoSysTM system 

so treatment at de-ballasting can be avoided or at least reduced, as this seems to 

create a relatively high initial toxicity of the treated ballast water at discharge. 

10.4.3 The Group suggested that MEPC invites the Administration of Sweden to ensure that all 

the above conditions are taken into account and appropriate measures are put in place during 

further development and testing of the EctoSysTM. 

10.4.4 Furthermore, the group wants to emphasize that it cannot judge whether a full-scale 

deployment would cause unacceptable environmental damage as no representative and realistic 

emission scenarios are available. Consequently, suitable realistic scenarios describing emissions 

of treated ballast water into representative water courses should be developed, documented and 

applied for assessing the environmental risks under full-scale deployment of the proposed 

system. Such scenarios should describe various release situations with regard to dimensions of 

the receiving environment, water flow and exchange, number of ships, frequency, duration and 

volume of discharges of treated ballast water, etc. The Group encourages MEPC to consider the 

development and agreement of such emission scenarios, which should then be applied by the 

applicant in an eventual application for Final Approval. 

11 REFERENCES 

11.1 In evaluating the application, the Group made use of the following references: 

 .1 Application Dossier 

 .2 Summary (MEPC 55/2/4) 

 .3 Disinfectants and Disinfectant By-Products (Environmental Health Criteria 216, 

(WHO, 2000) 

 .4 Bromate in Drinking Water (WHO/SDE/WSH/05.08/78, 2005) 

 .5 US-EPA: EPI Suite estimation program and database 

 .6 Danish EPA (1995): Guidance document for risk assessment of industrial 

wastewater. Danish EPA, Environmental Project No. 298. 

*** 

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I:\MEPC\55\2-16.doc 

ANNEX 8 

TIMETABLE FOR ACTIVITIES RELATED TO THE 3RD MEETING OF THE 

GESAMP-BWWG

Date Activity 

15 December 2006 Deadline for submission of application dossiers and related 

documents. 

15 December 2006-16 February 

 2007 

Preparation of the meeting. 

19- 23 February 2007 3rd Meeting of the GESAMP-BWWG. 

26 February - 2 March 2007 Editing and completion of the draft report. 

5-9 March 2007 Administrations confirm that no confidential data is 

contained in the report. 

12 March – 6 April 2007 Review and approval by GESAMP. 

9- 13 April 2007 Produce the final report based on comments by GESAMP. 

13 April 2007 13 weeks deadline for MEPC 56 documents. 

___________