INTERNATIONAL MARITIME ORGANIZATION

E
IMO

MARINE ENVIRONMENT PROTECTION

COMMITTEE
54th session
Agenda item 2

MEPC 54/2/12
28 February 2006
Original: ENGLISH

HARMFUL AQUATIC ORGANISMS IN BALLAST WATER

Report of the first meeting of the GESAMP-BWWG
Note by the Secretariat
SUMMARY
Executive summary:

This document contains the report of the first meeting of the

GESAMP Ballast Water Working Group (GESAMP-BWWG)
including the evaluation of the proposals for approval of Active
Substances submitted by Germany and the Republic of Korea

Action to be taken:

Paragraph 4

Related document:

MEPC 53/24

1
MEPC 53 instructed the Secretariat to explore the possibility of establishing a technical
group under the auspices of GESAMP to review the proposals for approval of Ballast Water
Management systems that make use of Active Substances. Through sustained efforts and under
significant time pressure, a GESAMP-Ballast Water Working Group was established and held its
first meeting from 23 to 27 January 2006 to evaluate two submissions by Germany and the
Republic of Korea.
2
Although the Committee did not consider the non-confidential description of the
technology by the Republic of Korea, as it was the case for Germany, the proposal for approval
by the Republic of Korea was accepted for evaluation by the GESAMP-BWWG with the
understanding that if submitted to MEPC 54 by the 13-week deadline will still leave four weeks
for delegations to submit relevant information in time for the evaluation.
3
It should be noted that, according to the estimates done by the GESAMP-BWWG, at least
20 weeks are needed for the evaluation, production and submission of the report in accordance
with the Committees Guidelines for submission of documents, with an additional 8 weeks for
the preparation of the meeting. Members are, therefore, kindly requested to submit the
non-confidential description of their methodologies to the session of MEPC before the one
expected to be decided on Basic Approval, or at the earliest opportunity after, but not after the
28 week deadline before the Basic Approval session of the Committee (see table in annex 2).

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.

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Action requested of the Committee

4
The Committee is invited to take into account the report of GESAMP-BWWG when
deciding on the Basic Approval for the two proposals and to consider the timeline contained in
paragraph 3 for future submissions.
***

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ANNEX 1

GESAMP-BALLAST WATER WORKING

GROUP
1st meeting

GESAMP-BWWG 1/9
20 February 2006
Original: ENGLISH

REPORT OF THE FIRST MEETING OF THE

GESAMP-BALLAST WATER WORKING GROUP
Table of Contents
Section

Paragraph Nos.

Page Nos.

INTRODUCTION ...............................

1.1 1.4

ISSUES OF CONFIDENTIALITY .....

2.1 2.3

3-4

TERMS OF REFERENCE ..

3.1 3.4

4-5

DEVELOPMENT OF A DRAFT METHODOLOGY

FOR INFORMATION GATHERING AND THE
CONDUCT OF WORK OF GESAMP-BWWG..

4.1 4-16

57

REVIEW OF PROPOSALS FOR APPROVAL OF

ACTIVE SUBSTANCES SUBMITTED BY
GERMANY AND THE REPUBLIC OF KOREA .

5.1 5.10

7 - 10

MATTERS ARISING FROM RECENT IMO

ACTIVITIES ..

10

CONSIDERATION OF QUERIES FROM MEMBERS

AND INDUSTRY

7.1 7.2

10 - 11

FUTURE WORK PROGRAMME AND TENTATIVE

DATE FOR THE NEXT MEETING ..

8.1 8.4

11 - 12

CONSIDERATION AND ADOPTION OF THE

REPORT ..

9.1 9.4

12

6
7
8
9

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ANNEXES
ANNEX 1

LIST OF MEMBERS ATTENDING THE FIRST SESSION OF THE GESAMP

BW WORKING GROUP

ANNEX 2

AGENDA FOR THE FIRST SESSION OF THE BALLAST WATER

WORKING GROUP OF GESAMP

ANNEX 3

TERMS OF REFERENCE
WORKING GROUP

ANNEX 4

DRAFT METHODOLOGY FOR INFORMATION GATHERING AND THE

CONDUCT OF WORK OF GESAMP-BWWG

ANNEX 5

REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES

SUBMITTED BY GERMANY (PERACLEAN OCEAN)

ANNEX 6

REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES

SUBMITTED BY REPUBLIC OF KOREA (ELECTROCLEAN)

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FOR

THE

GESAMP-BALLAST

WATER

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INTRODUCTION

GESAMP Ballast Water Working Group (GESAMP-BWWG) was held at IMO Headquarters,
London, from 23 to 27 January 2006, under the chairmanship of Mr. Finn Pedersen. A list of
members attending this first meeting is shown in annex 1, and the agenda, as approved by the
Group, is set out in annex 2.
1.2
Mr. Ren Coenen, IMO Technical Secretary of GESAMP, drew attention to the history,
developments and merits of GESAMP as the advisory scientific and multi-disciplinary body
within the United Nations system. Mr. Dandu Pughiuc, Head of the IMOs Office for Ballast
Water Management, and the Secretary for this meeting, briefed the Group on resolution
MEPC.126(53), which had been adopted in summer 2005, concerning the Procedure for
Approval of Ballast Water Management Systems that make use of Active Substances (G9).
Essentially, the approval procedure consists of two steps:

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

approval of a Ballast Water Management System based on a satisfactory submission of a
manufacturer developed in accordance with the (G9) and the further details of criteria as
being developed by the GESAMP-BWWG. In principle, the basic approval allows the
further development of the Ballast Water Management System through full-scale onboard ship development and testing.
Final approval: When full-scale on-board ship development and testing has been
satisfactorily completed, the Member of the Organization may apply for a final approval
of a Ballast Water Management System in accordance with Regulation D-3.2.

The Organization will record the Basic and Final Approval of Active Substances and
Preparations and Ballast Water Management systems that make use of Active Substances and
circulate the list once a year including the following information:

Name of Ballast Water Management system that make use of Active Substances and
Preparations;
Date of approval;
Name of manufacturer; and
Any other specifications, if necessary.

When a final approval has been given and the respective Active Substance included in the IMO
list, the respective Administration may issue the Type Approval Certificate in accordance with
the guidelines developed by the Organization.
1.3
GESAMP-BWWG was tasked to develop methodologies and information requirements
for conducting its work and to review the proposals submitted by Governments of IMO Members
for the approval of Active Substances in accordance with the Terms of Reference developed by
the Committee and accepted by the GESAMP Inter-Secretariat.
1.4
The Group considered its terms of reference and included some small amendments. The
terms of reference, as agreed by the Group, are shown at annex 3.
2

ISSUES OF CONFIDENTIALITY

2.1
Applications for Basic Approval regarding the use of Active Substances had been
submitted by two members of the Organization, namely, Germany and the Republic of Korea.
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The Secretariat informed the Group that part of the information packages submitted by Maritime
Administrations of IMO Members was non-confidential and was considered for submission to
MEPC 54. The Secretariat further emphasized that members of this Group were obliged to keep
relevant data of the submission confidential to protect the commercial interests of the producing
companies. The Group suggested that, after completion of the approval procedure, the following
data and information should no longer be regarded as confidential:

The name and address of the applicant

The names and addresses of the manufacturers of the Active Substance and/or the
preparation (if different)

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

The names of other substances which are regarded as dangerous according to the
UN GHS or relevant IMO regulations and contribute to the hazard documentation of the
preparation

Physical and chemical data concerning the Active Substance and preparation

A summary of the results of the tests required pursuant to Section 4.2 of the Procedure to
establish the effects of the substance(s) or preparation(s) on humans and the environment

Recommended methods and precautions against dangers resulting from handling, storage,
transport and fire

Any means of rendering the active substance or preparation harmless

Safety data sheets

Methods of chemical analysis

Methods of disposal of the product and of its packaging

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

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

2.2
In evaluating an application, the Group reserves its right to base its evaluation on any
available information and to use this information for justifying its conclusions and
recommendations in its evaluation reports irrespective of confidentiality issues. However, the
Group would recommend that the Organization prior to submission of the Groups evaluation
report to the MEPC consults with the Member of the Organization having proposed the Ballast
Water Management System. In cases where the evaluation report contains confidential
information, the Organization should decide on the future procedures.
2.3
In case there were requests to IMO for more information regarding an application, the
Organization would provide the name and address of the responsible national administration
which originally submitted the application for the Basic Approval. It could then respond, as it
feels appropriate.
3

TERMS OF REFERENCE

3.1
An expanded version of the Terms of Reference had been proposed to the
GESAMP-Ballast Water Working Group. The Group, at its first session, reviewed the expanded
form and introduced some small amendments. The expanded version, as adopted, is shown in
annex 3. GESAMP is invited to confirm the Terms of Reference as annexed to this report.
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3.2
When considering its Terms of Reference, the Group noted the disproportionality
between the resources available for the approval system developed for Ballast Water
Management Systems that make use of Active Substances and the far more comprehensive
international authorization systems for biocides and pesticides. International authorization
systems for biocides and pesticides make use of detailed guidance documents developed through
years of experience. The evaluation of risks to human health and the environment is a process
that requires substantial resources from the authorizing administrations.
3.3
Consequently, the Group considered it overly optimistic to expect that a well elaborated
draft methodology for information gathering and conduct of work of the GESAMP-Ballast Water
Working Group could be developed during the few meeting days available, as well as thorough
evaluations of proposals for approval of two applications regarding Active Substances.
3.4
The Group also suggested that MEPC may wish to look further into the Procedure for
approval of the use of Ballast Water Management systems that make use of Active Substances,
with a view to aligning the evaluation procedures and the levels of ambition with similar
international systems for authorization of the use of toxic chemicals as, e.g., biocides and
pesticides.
4

DEVELOPMENT OF A DRAFT METHODOLOGY FOR INFORMATION

GATHERING AND THE CONDUCT OF WORK OF GESAMP-BWWG

4.1
The Group noted that the MEPC Procedure for approval of ballast water management
systems that make use of active substances (G9) would form the basis for its work. In addition,
the submission of the European Commission MEPC 54/2/1 to MEPC 54 was seen as useful
guidance in defining the approaches for evaluation of proposals for approval of Active
Substances.
4.2
Prior to the meeting, the Secretariat had developed and circulated a first draft of a Draft
Methodology for Information Gathering in Accordance with the Procedure for Ballast Water
Management Systems that make use of Active Substances (G9), which was based on the two
aforementioned documents. The Group appreciated the work done and considered the document
as a good starting point for the further development of the methodology requested.
4.3
However, in discussing the possible approaches, the Group also noted a number of
apparent inconsistencies in Procedure (G9).
4.4
Some of the data required for preparation (mixtures of substances) according to (G9)
were seen as inappropriate. These include partition coefficients, biodegradation and
bioaccumulation data, as it is the individual substances in the preparation that may, or may not,
degrade or accumulate rather than the preparation itself.
4.5
The Group considered the appropriateness of conducting long-term (chronic) toxicity
testing with preparations and treated ballast water and concluded that this would have to be
considered on a case-by-case basis. In general, when a complex mixture is released to the aquatic
environment, the individual substances in the mixture will most likely behave differently
(i.e. some substances may degrade, some may sorb to particulate matter, some may evaporate,
etc.) and after a short time, the organisms in the environment will not be exposed to the original
mixture any more. Therefore, only in cases where the use results in very frequent releases to the
same environment from different ships and where organisms in the environment therefore may
be frequently exposed to treated ballast water, an assessment based on long-term testing of the
preparation and/or the treated ballast water may be appropriate. In cases where only infrequent
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releases take place, an assessment based on the long-term testing of the individual substances in
the preparation would be more useful.
4.6
The Group discussed various approaches for structuring the draft methodology. Although
a structure reflecting the sequential order of assessment of the hazards and risks to the ship, the
crew and the aquatic environment might have been preferred, the Group considered that the
structure of Procedure (G9) should be followed. This was further emphasized by the fact that the
Group was informed that several applications were under development in various Member States
(cf. agenda item 8).
4.7
It is the intention that the draft methodology should serve two purposes. On the one hand,
it should be guidance to applicants on what to consider in their development of a dossier for the
Ballast Water Management system using Active Substances. On the other hand, it should also be
guidance to the Group in its evaluation and review of applications. The Group further noticed
that, for the moment, the guidance is mainly intended to relate to dossiers submitted for basic
approval. Furthermore, the Group considered that a submission for final approval could probably
not be standardized, as a basic approval on a case-by-case basis might include preconditions that
need to be addressed during the full-scale development and testing and eventually reported in
connection with the application for the final approval.
4.8
The draft methodology developed by the Group is attached as annex 4. MEPC is invited
to comment on the draft and review its contents, as appropriate.
4.9
The Group recommends that future applications for basic approval of a Ballast Water
Management System should be prepared in accordance with the methodology proposed by the
Group (cf. Annex IV) in order to ensure the completeness of the application and to facilitate the
Groups work.
4.10 In addition, for future applications, the applicant is requested to complete a key data
summary table to enable the Group to have an overview of the properties of the product. A blank
key data summary table has been developed by the Group for this purpose and is included in
annex 4.
4.11 The assessment of the potential risks to the environment basically requires that a
Predicted Environmental Concentration (PEC) can be established and compared to a Predicted
No-Effect-Concentration (PNEC). When the PEC does not exceed the PNEC, it is considered
likely that no unacceptable toxic effects will occur.
4.12 In discussing possible scenarios for discharge of treated ballast water to the aquatic
environment, the Group realised that information was not available on basic assumptions
regarding the likely volume of treated ballast water, the duration and frequency of discharge, and
the dimensions of the receiving aquatic environment including area, water volume, water flow,
etc. Therefore, the Group considered the need to develop a generic Emission Scenario Document
(ESD) on ballast water in a way similar to the ESDs, developed by the OECD, on antifouling
paints as well as multiple other ESDs for various product types developed by the OECD, EU and
USA. A development of the most likely scenario, both short- and long-term, for discharge of
treated ballast water including documentation of appropriate models is needed. Considering the
efforts needed for developing such ESDs, the Group decided that development of an ESD for
ballast water would not be possible within the very limited time available. Instead the Group
recommends MEPC to initiate such a development, which pertains to all Ballast Water
Management systems and is seen as crucial for a thorough evaluation of the environmental risks
of discharge of ballast water.
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4.13 The Group also notes that several assessment factors (the value used to determine the
PNEC from the no-effect concentration determined experimentally) are currently in international
use. The Group intends to discuss assessment factors at the next meeting.
4.14 Section 2.3 of the Terms of Reference for the Group gives a mandate to assess the risk to
crew safety. The Group therefore thinks that the applicant should be required to provide a
preliminary assessment of risks to ship, crew and the environment, which is not a requirement
stated in the Procedure (G9).
4.15 The Group considered that toxicity of treated ballast water at discharge needs special
attention. Usually, 100% ballast water will contain active ingredients above the LC50 of the most
sensitive species. The risk assessment requires the use of a dilution factor (the amount of
short-term dilution that occurs as the ballast water enters the aquatic environment) in order to
conclude that products may be used safely. The Group was unsure as to whether the intention of
MEPC was to prevent the use of products that required the use of a dilution factor to reach a
favourable conclusion in the risk assessment. The Group requested clarification of this issue from
MEPC.
4.16 The Group took note of the intention to limit the effects to the environment as much as
possible, based on the requirement of the PEC/PNEC ratio < 1 as an initial analysis, but the
Group recommends the development of a tiered system in which an appropriate risk assessment
may show that the substance can be safely applied without unacceptable risks to the environment.
5

REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES SUBMITTED BY GERMANY AND THE REPUBLIC OF KOREA

Submission by Germany
5.1
The Group evaluated the application dossier submitted by Germany on the use of
Peraclean Ocean as a biocide for treatment of ballast water. In doing so, the Group noticed that
despite the voluminous application dossier, some information is missing which prevented a full
evaluation of possible risks to ship, crew and the environment:

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

of the safety to ship and crew.
Data on realistic occupational exposure scenarios required in order to characterize human
health risk of use and handling.
Justification for use of scenarios for modelling environmental exposure concentrations
and assumptions and details of the modelling;
Tests with treated ballast water on more species, including long-term data.
Justification for non-submission of data in cases where the data requirements of G9 are
not fulfilled.
The application dossier does not include documentation of the quality-control/qualityassurance programme as requested in Procedure (G9): 4.2.4.

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5.2
In evaluating the application, a number of concerns were raised regarding risks to both
ship, the crew and the environment that did not allow that the Group would recommend an onboard ship testing to be conducted before further studies have been conducted. The matters of
concern were:

Peraclean Ocean and the components of the preparation possess some toxicological
properties, such as, irritation and corrosiveness that may cause a risk to the ship and its
crew, if not managed properly because of the specific hazards associated with storage and
use on board ship (e.g. movement of ship, venting of gases from the product, control of
temperature, corrosion).

A number of concerns in relation to safety of ships have been raised due to the
physicochemical hazards of Peraclean Ocean. These concerns need to be addressed prior
to initiation of full-scale testing on board ships. The Group recommended, as mandatory,
the application of RMM (risk management measures) for the protection of the potentially
exposed populations (mainly the crew) to the main routes of concern: dermal and
inhalation. These control measures (Personal Protective Equipment - PPE and Respiratory
Protective Equipment - RPE) should be described and implemented, and must be put in
place for use and handling of the preparation at the different stages of the process and
with the different concentrations applied.

5.3
After a careful evaluation of the available information, the Group recommended that a
basic approval be issued allowing a further land-based development and testing. During this
phase, the above-mentioned concerns should be considered. Only when the development of the
technology and further assessment of risks to ship, crew and the environment have been
completed to the satisfaction of the respective Administration should a full-scale on-board testing
be initiated.
5.4
Before a final approval can be issued, a number of issues need to be investigated and
concluded on. These include:

The Group recommended that dermal and inhalation sub-chronic effects raised in some
studies should be further investigated, taking into account realistic occupational exposure
scenarios and covering non-accident situations. These data should be submitted before
final approval. The irritation effects in the respiratory tract triggered should be further
investigated in a repeated-dose inhalation study in order to assess the toxicity of the
substance at lower dose exposure. Additionally, a dermal absorption study in vitro with
intact skin at lower doses (diluted concentrations) should be conducted to anticipate the
risk of occupational exposure in non accidental situations.

Insufficient information was available on the likely composition and aquatic toxicity of
ballast water after treatment and this needed to be studied.

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

Ocean, particularly hydrogen peroxide, during treatment of ballast water as it seems to
depend on the content of organics and particles in ballast water. This should be further
studied and reliable estimates or measurements of concentrations of the components at
discharge should form the basis for the environmental risk assessment.

Exposure modelling has been performed using the MAMPEC model. The assumptions on
the scenarios as well as input parameters of the model are not presented in detail, which
hinders the evaluation of the reliability of the model results. The Group would require

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access to the input data and more information on the parameters within the model in order
to ascertain the validity of the results. Justification for the use of the models needs to be
provided.

5.5

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

submitted for a final approval.
The evaluation report is included as annex 5 to this report.

Submission by the Republic of Korea

5.6
The Group evaluated the application dossier submitted by Republic of Korea (ROK) on
the ELECTRO CLEAN system (ECS) as a possible methodology for treatment of ballast water.
In doing so, the Group noticed that the dossier does not live up to the basic requirements as
specified in the (G9) Procedure. In particular, the following information is missing:

Effects of the maximum total residual chlorine (TRC) concentration (20-30 mg/l) and also
a quantitative risk assessment to the environment.
Information on the reliability and accuracy of the control scheme.
The dossiers do not provide any data on the corrosivity of the treated ballast water.
Data on human exposure to the active substances not allowing risk evaluation of use and
handling.
Justification of non submission of data.
Calculation of the predicted environmental concentration (PEC) in the dossier and in
document MEPC 54/2/3 are based on the MAMPEC modelling from the German
application. The Group had several comments to the MAMPEC model results and further
pointed out that to use these without access to the input data does not produce any
valuable data. The calculated PEC values are therefore only used as indicative estimates
in this assessment.
The application dossier does not include documentation of the quality control/quality
assurance programme as requested in Procedure (G9): 4.2.4.

5.7
In evaluating the application, a number of concerns were raised regarding risks to both
ship, the crew and the environment that did not allow that the Group would recommend an onboard ship testing to be conducted before further studies have been conducted. The matters of
concern were:

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

chlorine (TRC) to levels that avoid risk to the environment in the case of short trips and
during the treatment of clean waters where the toxicity half-life seems to be longer. It
seems that the application of the ECS leads to creation of substantial amounts of very
reactive species, in particular chlorine solutions, that may result in increased corrosion of
the tank and piping. The potential damage to the ship has not been described.

The amounts of total residual chlorine (TRC) formed during the electrolytic process result
in concentrations in the treated ballast water that largely exceed limit values established
for discharge of waste water from land-based point sources. The degradation rate of TRC
is so low that substantial concentrations may be expected also at discharge of treated
ballast water. In addition, the potential health risk that may arise from human/mammalian
exposure to chlorinated by-products have not been sufficiently characterized.

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The formation of chlorinated and brominated by-products is not sufficiently described.

The Group is aware that plenty of studies have been conducted on formation of such
products and their environmental risks during electrolytic processes and during
chlorination. This needs to be further studied.

Acute aquatic toxicity tests have been conducted with sea water to different species
immediately after treatment with ECS. The tests showed that a dilution of up to more than
100 times is required before acute toxicity can be avoided. The degradation of toxicity in
the ballast water prior to discharge and the likely toxicity at discharge should be further
studied.

Exposure modelling has been performed using the MAMPEC model. The assumptions on
the scenarios as well as input parameters of the model are not presented in detail, which
hinders the evaluation of the reliability of the model results. The Group would require
access to the input data and more information on the parameters within the model in order
to ascertain the validity of the results. Justification for the use of the models needs to be
provided.

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

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

The dossier does not include documentation of which substances are produced in a
possible fresh water application. A full documentation of their properties should be
included.

Further land-based studies should be conducted to address the concerns for short- and
long-term impacts to the receiving waters before initiating before on-board testing takes
place.

5.8
After a careful evaluation of the available information, the Group recommended that a
basic approval be issued allowing a further land-based development and testing. During this
phase, the above-mentioned concerns should be considered. Only when the development of the
technology and further assessment of risks to ship, crew and the environment have been
completed to the satisfaction of the respective Administration should a full-scale on-board testing
be initiated.
5.9
Before a final approval can be issued, the risks to ship, crew and the environment need to
be further investigated and reported on based on the issues mentioned above and any other
information that is obtained during the further development work.
5.10

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

MATTERS ARISING FROM RECENT IMO ACTIVITIES

The Group noted that the Administrations of Sweden, Japan and Singapore have indicated
their intention to submit proposals for a basic approval of Active Substances during the coming
months. The Group agreed to take this information into account when considering its future
programme under agenda item 8.
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CONSIDERATION OF QUERIES FROM MEMBERS AND INDUSTRY

7.1

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

7.2

.1

Should Basic Approval preclude land-based testing?

.2

If Land-based testing has been conducted before receiving basic approval, should
they be conducted again after the basic approval has been granted?

.3

Can the Administration decide on the order of the land-based testing, request for
basic approval and shipboard testing?

.4

Is the Type Approval Certificate for Ballast Water Management systems that use
Active Substances issued by the National Administration or by IMO?

The Group offered the following views:

.1

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

ballast water management system, and is a practical way to initiate the research. It
was also felt that land based testing should normally be conducted in accordance
with national regulations and standards. The Group further noted that there was no
follow-up range of testing on land or on board ship that could be advised. The
more results from testing, even from different locations, became available, the
easier it was to establish a proper risk assessment regarding potential effects on
board and in coastal areas.

.2

The Group believed that the queries referring to a procedural aspect (7.1.2 to
7.1.4) may need to be referred to MEPC. The Group felt that this matter was
beyond its area of expertise.

FUTURE WORK PROGRAMME AND TENTATIVE DATE FOR THE NEXT

MEETING

8.1
Based on the first experience with the evaluation of proposals for approval of Active
Substances submitted by IMO Members, the Group considers that a greater effort should be
undertaken in securing that the application dossier was complete and that it conformed to the
basic requirements of Procedure (G9). If such basic requirements are not fulfilled, it may reduce
the evaluation capacity of the Group and, in worst cases, it might prevent that the evaluation of a
proposal be concluded.
8.2
The Group also noted that the approval system was a new activity of the Organization and
its members and that it was necessary to gain practical experience and to adapt the system
accordingly in order to create a well functioning system.
8.3
The Group further noted that the lack of guidance to applicants on the development of
application dossiers for ballast water treatment systems had resulted in the two applications
considered at this first meeting lacking important information. This had caused major difficulties
for the Group in its evaluation of possible risks to ships, crew and the environment. The
conclusions of the Group should be seen in this context.
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8.4

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The Group noted the following points for future work:

A thorough risk assessment needs to be included in the application dossier specifying the
used scenarios, the relevant exposures of crew and the environment, and the potential
effects and risks.

The Maritime Administrations of the member states should evaluate and be satisfied with
the state of the dossiers for compliance with Procedure (G9) and available guidance
before submission to the Group.

The Group may need an additional expert in mammalian toxicology

The Group has a limited capacity for processing applications within the timeframe
specified for the activity of the Group. Provided that the above conditions are fulfilled,
the Group finds it possible to evaluate two to three application dossiers for basic approval
per meeting (5 working days). There is potential for greater capacity once the
methodology has been developed and is being used by applicants. However, the Group
wants to reiterate once again that the level of detail in assessment under the proposed
conditions is far below a scientifically satisfactory level as currently practised in similar
international authorisation schemes.

The Group would find it useful to have a contact within the applicant company to whom
technical questions could be addressed during the Groups meeting, particularly relating
to the ballast water management system.
CONSIDERATION AND ADOPTION OF THE REPORT

9.1
The Group adopted the report and the Chairman thanked the members of the Group for
their efforts.
9.2
At the conclusion of this first session, Mr. J.-C. Sainlos, Director of the Marine
Environment Division of the Organization and Administrative Secretary of GESAMP thanked
the Chairman and the members of the working Group for their efforts. Noting the proposal of the
Group that additional expertise in human toxicology was needed to facilitate its future work, the
Secretariat would look into this matter.
9.3
The Group agreed that its next session should tentatively be held 22-26 May 2006 to
allow sufficient time for the evaluation, production of the report and submission to MEPC in
accordance with the Guidelines on organization and method of work of the Committee
(MSC/Circ.1099, MEPC/Circ.405).
9.4

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

***

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ANNEX 1
LIST OF MEMBERS ATTENDING THE FIRST SESSION
OF THE GESAMP BW WORKING GROUP
Mr. Finn Pedersen (Chairman)
Special Adviser
Danish Environmental Protection Agency
Chemicals Unit
Strandgade 29
DK-1401 Copenhagen
Denmark

E-mail:
Tel:

fpe@mst.dk
+45 32 660289

Ms. Teresa Borges

Senior Technical Officer
General Health Directorate
Alameda D. Afonso Henriques, 45
P-1049-005 Lisbon
Portugal

E-mail:
Tel:

tborges@dgsaude.min-saude.pt
+351 218430593

Mr. Egil Dragsund

Principal Marine Biologist
Environmental and Technical Solutions
Det Norske Veritas AS
Veritasveien1
NO- 1322 Hvik
Norway

E-mail:
Tel:
Fax:
Mobile:

egil.dragsund.dnv.com
+47 67 57 8894
+47 67 57 9911
+47 97 02 6956

Mr. Shinichi Hanayama

Senior Research Fellow
Maritime Technology Department
Ocean Policy Research Foundation
1-15 Toranomon
Minatoku-ku
Tokyo105-0001
Japan

E-mail:
Tel:
Fax:

s-hanayama@sof.or.jp
+813 3502 1886
+813 3502 2033

Mr. Jan Linders

Expert in Environmental Risk assessment
of Pesticides and Biocides
RIVM-SEC
P.O Box 1
NL- 3720 BA Bilthoven
Netherlands

E-mail:
Tel:
Fax:

jan.linders@rivm.nl
+31 30 274 3164
+31 30 274 4401

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Mr. Celso Mauro

Technical Consultant
PETROBRAS -CENPES
Av. Jequitib 950
Cidade Universitria
Ilha do Fundo, Rio de Janeiro
RJ CEP: 21941-598
Brazil

E-mail:
Tel:
Fax:

cmauro@petrobras.com.br
+55 21 38656659
+55 21 38654975

Mr. David Tongue

Marine Manager
International Chamber of Shipping
12 Carthusian Street
London EC1M 6EZ
United Kingdom

E-mail:
Tel:
Fax:
Mobile:

david.tongue@marisec.org
+44 2074718844
+44 2074178877
+44 (0)7855391258

E-mail:
Tel:
Fax:

info@alchemycompliance.com
+44 115 878 1489
+44 115 8781489

E-mail:
Tel:

manfrednauke@aol.com
+44 208 445 7958

IMO GESAMP CONSULTANTS

Dr. Mel Cooke
Director
Alchemy Compliance Ltd.
7 Western Fields
Ruddington
Nottinghamshire NG11 6JE
United Kingdom
Dr. Manfred Nauke
Technical Adviser to IMO
Marine Environment Division
16 Green Bank
Woodside Avenue
London N12 8AS
United Kingdom
IMO SECRETARIAT
Mr. Dandu Pughiuc
IMO Technical Secretary to GESAMP/BWWG
International Maritime Organization
Marine Environment Division
4 Albert Embankment
London SE1 7SR
United Kingdom

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E-mail:
Tel:
Fax:

dpughiuc@imo.org
+44 (0)20 7587 3247
+44 (0)20 7587 3261

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- 15 Mr. Ren Coenen
IMO Technical Secretary to GESAMP
International Maritime Organization
Marine Environment Division
4 Albert Embankment
London SE1 7SR
United Kingdom

E-mail:
Tel:
Fax:

***

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rcoenen@imo.org
+44 (0)20 7587 3239
+44 (0)20 7587 3261

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ANNEX 2
AGENDA FOR THE FIRST SESSION OF THE
BALLAST WATER WORKING GROUP OF GESAMP
1

Introduction

Issues of confidentiality

Terms of Reference

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

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

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

Matters arising from IMO and other Organizations relevant to the activity of the
GESAMP-BWWG

Consideration of queries from members and industry related work of the

GESAMP-BWWG

Future work programme and tentative date for the next meeting

Consideration and adoption of the report

***

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ANNEX 3
TERMS OF REFERENCE FOR THE
GESAMP-BALLAST WATER WORKING GROUP
This document is an expanded version of the terms of reference for the Group and
includes in full relevant reference to the G9 procedures.
1

Prepare the draft of methodologies and information requirements in accordance

with G9 for consideration by MEPC 54.

For Basic Approval - review the comprehensive proposals submitted by

Members of the Organization, along with additional data that have been
submitted, as well as other information available to the Group and report to the
Organization, in particular, the Group shall undertake the:
.1

Scientific evaluation of the data set out in the proposal for approval (G9,
paragraph 4.2, 6.1, 8.1.2.3, 8.1.2.4), i.e.:
(a)

data on effects on aquatic plants, invertebrates, fish and other biota,

including sensitive and representative organisms:
-acute aquatic toxicity
-chronic aquatic toxicity
-sediment toxicity
-bioavailability/biomagnification/bioconcentration
-food web/population effects

(b)

data on mammalian toxicity:

-acute mammalian toxicity
-effects on skin and eye
-chronic and long-term toxicity
-developmental and reproductive toxicity
-carcinogenicity, mutagenicity

(c)

data on environmental fate and effect aerobic and anaerobic:

- modes of degradation (biotic, abiotic)
- bioacculumation, octanol/water partition co-efficient
- persistence and identification of the main metabolites in
ballast water (marine and fresh water)

(d)

data on physical and chemical properties of Active Substances and

preparations and the treated ballast water, if applicable:
-melting points
-boiling points
-flammability

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-water solubility, dissociation constant (pKa)
-oxidation/reduction potential
-corrosivity to the material and equipment of normal ship
-autoignition temperature, and
-other known relevant physical chemical hazards

(e)

review of analytical methods at environmentally relevant

concentrations,

taking into account that testing procedures must contain rigorous quality
control/ quality assurance programme consisting of both:
- a quality management plan (QMP), and
- a quality assurance project plan (QAPP)
.2

Scientific evaluation of the assessment report contained in the proposal for

approval including the toxicity testing procedures with treated ballast
water, i.e.:
-acute aquatic toxicity:
short term L(E) Cx from freshwater or saltwater representatives of algae,
crustacean and fish
-chronic toxicity:
long-term NOECS or ECx, algae, crustacean and /or fish or other relevant
species representing at least three trophic levels

.3

Scientific evaluation of risks to ship and personnel including handling,

storage and application:
-hazard profiles, Material Safety Data Sheet
-physical and chemical properties,
-mammalian toxicity
taking into account trade circumstances (ice, tropical areas, etc.)

.4

Scientific evaluation of any further information that has been provided:

Contributions submitted by Parties, IMO-Members, UN agencies,
Non-Governmental Organizations and Governmental Organizations to the
request for approval

.5

Scientific review of the risk characterisation and analysis in the proposal

for approval:
-Evaluate potential impact in regard to:

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!

GESAMP-BWWG 1/9

toxicity of Active Substances in treated ballast water and BW

discharges
production of free radicals, production rates
route of abiotic and biotic degradation, identify degradation rates under
specified conditions, e.g. pH, redox, temperature

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

normalised distribution coefficient (KOC)
-assess the potential for bioaccumulation in marine
or freshwater organisms if log POW is >3
-predict discharge concentrations at selected time intervals
- effects of Active Substances etc. on primary producers (algae)
consumers (crustaceans) and predators (fish) as well as secondary
poisoning
of mammalian and avian top-predators
-in case of lack of bioconcentration potential (BCF <500 L/g), an
assessment of secondary poisoning is redundant
- in case the potential for partition into the sediment is low
(e.g. KOC <500 L/ g) an assessment of sediment species is redundant
-effect assessment shall include the screening on carcinogenic, mutagenic
and endocrine disruptive properties
-effect assessment should be based on internationally recognised
guidelines
.6

Prepare scientific recommendations on whether the proposal demonstrated

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

.7

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

MEPC

For the Final Approval - the Group should review the discharge testing data and
confirm that the residual toxicity of the discharges conform to the evaluation
undertaken for the Basic Approval taking into account also handling, storage and
application requirements.

The Group shall keep confidential all data, which might undermine the
commercial interests of the applicant.

***
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- 20 ANNEX 4

Draft Methodology for Information Gathering in Accordance

with the Procedure for Approval of BWM Systems that Make
Use of Active Substances G9
1

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

General.............................................................................................................................24

2.1

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

2.2

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

2.3

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

2.4

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

2.5

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

2.6

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

2.7

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

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

3.1.

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

3.2
Data on effects on aquatic plants, invertebrates and fish, and other biota, including sensitive and
representative organisms (G9: 4.2.1.1) ................................................................................27
3.2.1

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

3.2.2

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

3.2.3

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

3.2.4

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

3.2.5

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

3.2.6

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

3.3

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

3.3.1

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

3.3.2

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

3.3.3

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

3.3.4

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

3.3.5

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

3.3.6

Carcinogenicity ................................................................................................30

3.3.7

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

3.3.8

Toxicokinetics..................................................................................................31

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

3.4.1

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

3.4.2

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

3.4.3
Persistence and identification of the main metabolites in the relevant media (ballast water,
marine and fresh waters) ..................................................................................................32
3.4.4

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

3.4.5

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

3.4.6

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

3.4.7

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

3.5
Physical and chemical properties for the active substances and preparations and treated ballast
water, if applicable (G9: 4.2.1.5) .........................................................................................33
3.5.1

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

3.5.2

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

3.5.3

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

3.5.4

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

3.5.5

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

3.5.6

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

3.5.7

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

3.5.8

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

3.5.9

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

3.5.10

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

3.5.11

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

3.5.12

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

3.5.13

Viscosity ..........................................................................................................35

3.5.14

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

3.5.15

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

3.5.16

pH.....................................................................................................................35

3.5.17

Salinity .............................................................................................................35

3.5.18

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

3.5.19

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

3.6

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

3.6.1
4

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

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

4.1

The manner of application .......................................................................................35

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Material Safety Data Sheets.............................................................................................36

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

6.1

6.1.1

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

6.1.2

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

6.1.3

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

6.1.4

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

6.2

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

6.2.1

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

6.2.2

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

6.2.3

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

6.3

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

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

6.3.1

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

6.3.2

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

6.3.3

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

6.3.4

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

6.3.5

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

6.3.6

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

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

7.1

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

7.2

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

7.3

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

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

Final approval ..................................................................................................................42

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This document gives the responsibility of the applicant in providing data to the Organisation, and
the procedures used by the Organization for evaluating applications, according to Resolution
MEPC.126(53) on a Procedure for the approval of Ballast Water Management Systems That
Make Use of Active Substances (G9).
1

Terms and Definitions

For the purpose of this paper:

.1

Ballast Water Convention means the International Convention for the Control
and Management of 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

General obligation of the Convention means, Parties undertake to give full and
complete effect to the provisions of this Convention and the Annex thereto in
order to prevent, minimize and ultimately eliminate the transfer of Harmful
Aquatic Organisms and Pathogens through the control and management of ships
Ballast Water and Sediments. (Article 2, para. 1)

.4

Active Substances means Active Substances or Preparations containing one or

more Active Substances used to comply with the Convention.

.5

Basic Approval means the approval of a comprehensive proposal regarding the

use of Active Substances submitted by a Member, normally through its Maritime
Administration, to the Organization.

.6

GESAMP Ballast Water Working Group means the Technical Group that
reports through GESAMP to MEPC. When considering the comprehensive
proposal, the Group shall take account of any other relevant data as well as other
relevant information submitted to it.
GESAMP is the IMO/FAO/UNESCO-IOC/WMO/WHO/IAEA/UN/UNEP Joint
Group of Experts on the Scientific Aspects of Marine Environmental Protection,
an advisory and multi-disciplinary body consisting of specialised experts
nominated by the sponsoring agencies. Experts working for GESAMP act
independently in their individual capacity.

.7

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

additional data regarding operational practices on board ships and discharge
testing data from the field, i.e. in ports and harbours, estuaries, coastal zones, etc..
The Final Approval shall also confirm that previous evaluations of risks to ship
and crew including storage, handling and application of active substances remain
valid.

.8

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

after the issue of Basic Approval, the Member of the Organization concerned shall
submit a report to the Organization summarizing the results gained with the
experimental application of the Active Substance, as well as any consequences

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that had to be taken into account in improving the system. This report will include
all non-confidential and public information.
A comprehensive report comprising all data resulting from the experimental application,
including the confidential information will be submitted to the Organization for evaluation by the
GESAMP-BWWG following the procedure for Basic Approval. The Group shall report through
GESAMP to MEPC confirming that the residual toxicity conforms to the evaluation undertaken
for Basic Approval
2

General

2.1
Legal provision
Regulation D-3.2 of the International Convention for the Control and Management of 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).
2.2
Principles of acceptability regarding Active Substances or Preparations
Active Substances or Preparations accomplish their intended purpose through action on Harmful
Aquatic Organisms and Pathogens in 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 or Preparation as well as the
Ballast Water Discharge should be subjected to toxicity testing in order to protect the receiving
environment or human health from toxic effects due to the discharges. Toxicity testing is needed
to determine if an Active Substance or Preparation can be used and under which conditions the
potential of harming the receiving environment or human health is acceptably low (G9: 3.2).
Ballast Water Management systems that make use of Active Substances and Preparations must
be safe in terms of the ship, its equipment and the personnel to comply with the Convention
(G9: 3.3).
2.3
Data submission
Procedure to be followed: The manufacturer should evaluate the Active Substances or
Preparations and the potential discharge in accordance with the approval criteria specified below
(G9: 8.1.2.1). Upon completion, the manufacturer should prepare an Application on the Active
Substances and Preparations and submit it to the Maritime Administration of a Member of the
Organization concerned (G9: 8.1.2.2).
Applications for basic approval of Active Substances to be evaluated by the GESAMP Ballast
Water Working Group should be addressed to: The Director, Marine Environment Division,
International Maritime Organization, 4 Albert Embankment, London SE1 7SR, United Kingdom
Application requirements:
Complete application including all documents below (one paper version), including full
study reports and full copies of literature. The complete application should contain a
contents list indicating the location of the information in the application. The order in
which the information is presented, including overall structure such as how information is
presented for the active substance, preparation, ballast water, risk assessment, assessment
report, should follow this format, including its numbering, which is based on G9
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Non-confidential summary document (as provided to MEPC) to provide an overview of

the application (electronic version)
A summary of the key data should be provided in a tabular format (electronic version)
The assessment report (electronic version)

Dossiers already used for registration of chemicals can be used to satisfy the data requirements of
the G9 procedure (G9: 4.2.5).
2.4
Confidentiality and data protection
The confidential information of the submitted documents should clearly be identified.
Once an approval procedure is completed and the active substance is approved, the following
data shall not be regarded as confidential:

The name and address of the applicant

The names and addresses of the manufacturers of the Active Substance and/or the
preparation (if different)

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

The names of other substances which are regarded as dangerous according to the UN
GHS or relevant IMO regulations and contribute to the hazard documentation of the
preparation

Physical and chemical data concerning the Active Substance and preparation

A summary of the results of the tests required pursuant to Section 4.2 of the Procedure to
establish the effects of the substance(s) or preparation(s) on humans and the environment

Recommended methods and precautions against dangers resulting from handling, storage,
transport and fire

Any means of rendering the active substance or preparation harmless

Safety data sheets

Methods of chemical analysis

Methods of disposal of the product and of its packaging

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

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

2.5
Test Methods
Tests should be carried out by internationally recognized guidelines (preferably OECD or
equivalent) (G9: 4.2.3), and according to an internationally recognised quality assurance system
(G9: 4.2.4) (eg GLP).
Information may be derived from existing data where an acceptable justification is provided. Full
copies of sources of data (eg literature papers) should be provided.
Care should be taken to provide full supporting references and copies of the appropriate test
laboratory reports in support of each application. Submissions that are lacking relevant
information may not be accepted for risk assessment. Many substances have acquired large
databases for many of the hazards concerned and a weight of evidence approach has become
necessary to ensure that the rating reflects the body of data rather than simply using the most
conservative value. This, however, requires the submission of all available end-point data for
Active Substances and relevant chemicals.
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The applicant should supply a list of test substances (for example trade names) specified in study
reports and literature data and an explanation of how the tested substances relates to the current
application.
2.6
Alternatives to testing and non-submission of data
Methods alternative to testing on organisms, e.g. in vitro testing methods, QSAR, extrapolation
by analogy to known chemicals, or grouping of similar substances, may be used whenever
justified. Sufficient documentation or references to documentation, on the validity of the method
should be provided, as well as documentation that the substance or preparation lies within the
domain of the method.
Information which is not necessary owing to the nature of the substance or of its proposed uses
and taking into account all proposed risk management measures need not be supplied. The same
applies where it is not scientifically necessary or technically possible to supply the information.
In such cases a justification must be submitted.
2.7
Procedures and timelines
The procedures for evaluation of the dossier are given in the Appendix to G9.
If in the course of the review by the Ballast Water Working Group it becomes evident that
additional data is found to be necessary to finalize the evaluation, the Group may request that
such data is submitted.
The applicant will be informed in writing of the decision of the Organization. The applicant may
appeal against any decision made by the Organization. The Organization will consider the appeal
and respond in writing to the Member of the Organization.
It may be useful for a technical representative of the company to be available to the BWWG for
an hour or so to answer questions regarding the system.
3
Data-set required in the application
The dossier should contain the information specified in G9. Non-submission of information
should be justified.
For active substances and/or preparations as appropriate, data on properties should be included.
For other components in preparations that may contribute to the hazards, data should be provided
as well.
Fate and effect testing should be performed in the laboratory with active substances and
preparations (G9: 5.3.1). However, the Group notes that assessment of fate (including
degradation, bioaccumulation) is not feasible for preparations, but only for individual substances.
Therefore degradation and fate testing of preparations is not appropriate.
For treated ballast water, the applicant should provide both acute and chronic toxicity data (G9:
5.2.2). The discharge toxicity tests should include chronic test methods with test species (fish,
invertebrate, algae) that address the sensitive life stage (G9: 5.2.4). The results should include
acute LC50 values and NOECs, and chronic NOECs or EC50s (G9: 5.2.5). Therefore 100% ballast
water discharge should be tested (G9: 5.2.6), if appropriate.
3.1

Identification of the substance or preparation (G9: 4.1)

Preparation
The application should include a list of the name and relative quantities of the components (G9:
4.2.2)
Trade name
composition (liquids in g/l; solids in %w/w; gases in %v/v), including CAS numbers and
chemical names
UN number and name
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Active substance
Trade name, chemical (IUPAC) name, CAS number, UN number and name
Molar mass, empirical formula, structural formula
Purity of the technical material and identification of impurities (chemical name and CASnumbers)
Identity of any stabilisers or necessary additives
Relevant chemicals (G9: 2.1.4)
Chemical (IUPAC) name, CAS number
Molar mass, empirical formula, structural formula
3.2
Data on effects on aquatic plants, invertebrates and fish, and other biota, including
sensitive and representative organisms (G9: 4.2.1.1)
For every Active Substance or preparation data should be presented and discussed either on the
basis of toxicological tests or existing toxicological knowledge for each end point listed.
3.2.1 Acute aquatic toxicity
Short-term L(E)Cx from freshwater or saltwater1 representatives of three taxonomic groups
(algae, crustaceans and fish) representing three trophic levels (OECD guidelines 201 (Algae,
Growth Inhibition Test), 202 (Daphnia sp. Acute Immobilization Test) and 203 (Fish, Acute
Toxicity Test)), Mysid shrimp acute toxicity test (USEPA 850.1035), and an activated sludge
respiration inhibition test (OECD guidelines 209, and other well established guidelines) shall be
accepted. To reduce further any remaining uncertainty, applicants should preferably also submit
data for two additional marine taxonomic groups (e.g. echinoderms, molluscs).
Preparation
Active substance
Information on other components
Relevant chemicals
Treated ballast water (G9: 5.2.3)
3.2.2 Chronic aquatic toxicity
Long-term NOECs or ECx from three freshwater or saltwater species (normally algae and/or
crustaceans and/or fish) representing three trophic levels (e.g. Fish: OECD 210, 215, or 212;
Daphnia: OECD 211). To reduce further any remaining uncertainty, applicants should preferably
also submit two long-term NOECs from additional marine taxonomic groups (e.g. echinoderms,
molluscs).
In case of whole effluent testing, EPA short term methods for estimating the chronic toxicity of
substances and discharge provide acceptable alternatives, since the identification of the sensitive
sub-lethal endpoints and vulnerable life-stages is the ultimate aim of the long-term testing.
Preparation
Active substance
Information on other components
Relevant chemicals
1

The species tested should be relevant to the environments likely to be affected due to the manner of use or
disposal of the substance. Seawater species should be used if the substance is likely to influence directly or
indirectly only estuarine or marine environments. If a marine or brackish water environment is affected but it is
not the only aquatic target environment, then a toxicity test in a marine or in a brackish water species,
respectively is required in addition to the fresh water tests.

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

3.2.3 Endocrine disruption
Regarding the risks connected to endocrine disruption, non-standardized in vivo as well as in vitro
tests will be accepted as long as no internationally standardized tests are available (e.g. full-life-cycle
test on fish or amphibian metamorphosis assay). When substantial evidence on such effects is
available, this should be taken into account on a case-by-case basis in the PBT assessment (as a
substitute for the T end point) and in the effect assessment for each compartment of relevance. If
there is no indication for endocrine disruption e.g. due to the structure of the substance or results of
other available studies these tests may be waived.
Preparation
Active substance
Information on other components
Relevant chemicals
3.2.4 Sediment toxicity
Substances that are potentially capable of depositing on or adsorbing to sediments to a significant
extent have to be assessed for toxicity to sediment-dwelling organisms. Testing is required only if log
Kow > 5 or if there is similar adsorption behaviour and should include a maximum of three long-term
tests with species representing different living and feeding conditions (e.g. Chironomus spec. (OECD
218), Lumbriculus variegates) including a minimum of two tests with marine species.
For substances that are persistent in marine waters or may accumulate in sediments, a specific marine
sediment assessment is necessary.
Preparation
Active substance
Information on other components
Relevant chemicals
Ballast water
3.2.5 Bioavailability/biomagnification/bioconcentration
If log Pow > 3, testing should include:
One bioconcentration factor (BCF) determined in a bioconcentration study (at two dosing
levels) with fish (e.g. OECD 305) or bivalves. The BCF should be based on
uptake/elimination kinetics (k1/k2). The half-life for elimination should be reported. Fat
content in marine fish typically ranges between 0.5 and 15% of the whole body weight. BCF
should be normalized to 6% fat.
The biomagnification and persistence in the food web should be discussed based on the
results from aquatic toxicity testing, mammalian toxicity evaluation and bioaccumulation and
biodegradation data.
There are no data requirements on bio-availability since it is considered that the bioavailability in the toxicity test systems is equivalent to the conditions under assessment. If the
bioavailability of the Active Substance or relevant chemical in the discharge or the receiving
environment is to be assessed, consequently the bio-availability in the toxicity testing is to be
reconsidered.
Active substance
Information on other components
Relevant chemicals
3.2.6 Food web/population effects
The biomagnification and persistence in the food web should be discussed based on the results from
aquatic toxicity testing, mammalian toxicity evaluation and bioaccumulation and biodegradation
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data. An assessment of secondary poisoning is redundant if for the substance of concern absence
of bioaccumulation potential can be demonstrated (BCF <500 L/kg wet weight for the whole
organism at 6% fat). If not, testing should include:
One long-term NOECs based on reproduction studies with a bird species
Two NOECs from long-term studies with two mammalian species (from Section 2.3
below).
Active substance
Information on other components
Relevant chemicals
3.3
Data on mammalian toxicity (G9: 4.2.1.2)
Information which is not necessary need not be supplied (e.g. for a reduction of experiments
involving vertebrate animals, screening tests negative, appropriate risk management measures are
in place - see also point 2 above). In such cases a justification must be submitted. Lack of data
with missing justification will in general not allow any approval.
If available, human experience or epidemiological evidence should be presented and discussed.
3.3.1 Acute toxicity
The acute toxicity should be known for at least two routes of exposure, one of which should be
the oral route. Active Substances or Preparations that are gases or produce vapours during the use
should be tested by inhalation. The submission of dermal and/or inhalation studies instead of or
in addition to oral studies may be required depending on the physico-chemical properties of the
substance, the proposed or potential application of the substance/products. These tests should be
performed with the Active Substances or Preparation.
Preparation
Active substance
Information on other components
Relevant chemicals
3.3.2 Effects on skin and eye
The tests shall provide information on the degree and nature of skin, eye and associated mucous
membrane irritation, especially with regard to the reversibility of responses. The tests shall
provide sufficient information to assess the potential to cause skin sensitization reactions. Animal
testing should, whenever possible, be minimized. Tests should be performed with the Active
Substance(s).
Testing of Active Substances or Preparation should include a study on acute dermal
irritation/corrosion and a study on acute eye irritation/corrosion. The recommended tests are
OECD guidelines 404 (Acute Dermal Irritation/Corrosion) and 405 (Acute Eye
Irritation/Corrosion). These tests need not be carried out on a strong acid or base (pH below 2 or
above 11.5). Where the Active Substance or Preparation has shown to have potentially corrosive
properties, or is a severe skin irritant, eye irritation test shall not be carried out. It should be
possible to accept results from in vitro test methods, which are close to validation by recognized
organizations.
The recommended test for Skin Sensitization is OECD guideline 406. While the guinea-pig
Maximization test is considered to be the preferred adjuvant technique in certain cases there may
be good reasons for choosing the Buehler test or the Local Lymph Node Assay (LLNA).
However, scientific justification may be given when either of the two latter mentioned is used.
The test is not needed if the Active Substance or Preparation is already classified in an
internationally recognized system or otherwise known as a sensitizer.
Preparation
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Active substance
Information on other components
Relevant chemicals
3.3.3 Repeated-dose toxicity
A 90-day sub-chronic toxicity study in two species, one rodent and another mammalian species,
using the oral route unless another one is more appropriate.
Preparation
Active substance
Information on other components
Relevant chemicals
3.3.4 Chronic toxicity
A chronic toxicity study of a minimum duration of 12 months in two species, one rodent and
another mammalian species unless a full justification demonstrates that this test is not necessary.
Any chronic study can be combined with a carcinogenicity study.
Preparation
Active substance
Information on other components
Relevant chemicals
3.3.5 Developmental and reproductive toxicity
Testing should include:
A two-generation reproduction and fertility study (OECD guideline 416
Two-Generation Reproduction Toxicity Study)
A prenatal developmental toxicity (teratogenicity) study in two species (OECD
guideline 414 - Prenatal Developmental Toxicity Study).
However, these key data requirements can be modified (either reduced or accelerated or
extended) and influenced by factors such as structural relationships with a known reproductive
toxicant, the results of other toxicity studies (incl. toxicokinetics), concerns for endocrine
disruption and anticipated use and human exposure patterns.
Preparation
Active substance
Information on other components
Relevant chemicals
3.3.6 Carcinogenicity
Carcinogenicity studies for should be performed with one rodent and one other mammalian
species. The carcinogenicity testing of an Active Substance or preparation may not be required
where justification demonstrates that these tests are not necessary. Carcinogenicity studies may
be combined with the chronic toxicity studies.
Preparation
Active substance
Information on other components
Relevant chemicals
3.3.7 Mutagenicity/genotoxicity
Genotoxicity data should be available for Active Substances or preparations from at least three
tests: a bacterial gene mutation test, an in vitro mammalian cell cytogenicity study and an in vitro
mammalian cell gene mutation assay. In case of positive or equivocal results, further in vivo
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mutagenicity testing with bone marrow assay for chromosomal damage or a micronucleus test is
necessary. If this test is negative it should be evaluated whether mutagenicity or evidence of
DNA damage can be demonstrated in tissue other than bone marrow.
Preparation
Active substance
Information on other components
Relevant chemicals
3.3.8 Toxicokinetics
Basic data on toxicokinetics of Active Substances or Relevant Chemicals on adsorption,
distribution, metabolism and elimination (e.g. OECD 417) should be presented, if available, to
allow better understanding of toxic effects and a reduction of animal testing. The potential for
dermal absorption should be evaluated preferably in vitro or by phys-chem data to reduce the
need for any specific dermal toxicity testing.
3.4

Data on environmental fate and effect under aerobic and anaerobic conditions
(G9: 4.2.1.3)
The route of abiotic and biotic degradation of the Active Substances and other components under
aerobic and anaerobic conditions should be assessed, resulting in the identification of relevant
metabolites in the relevant media (ballast water, marine and fresh waters) (G9: 5.3.4).
The partition coefficients [solids-water partition coefficient (Kd) and/or organic carbon
normalized distribution coefficient (Koc)] of the Active Substances, other components and
Relevant Chemicals should be determined (G9: 5.3.6).
The data submitted in accordance with this paragraph should clarify, in addition to the
degradation of the substance, other relevant routes of dispersion in and from water, such as
volatilization, adsorption, sedimentation and transformation into bound residues. Accordingly the
exposure of organisms living in water and the sediment should be established.
3.4.1 Modes of degradation (biotic; abiotic)
Testing should include:

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

guideline 111

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

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

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

Seawater) or equivalent guidelines if the Active Substance is discharged only into marine
water
Studies on ready biodegradability according to OECD guideline 301 (or equivalent
guidelines) and OECD guideline 306 (or equivalent guidelines) if the Active Substance is
discharged into estuarine water (e.g. inland harbour with contact to seawater).

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

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

to OECD guideline 308 (Aerobic and Anaerobic Transformation in Aquatic Sediment
Systems) or equivalent guidelines if Koc >500 L/kg, using fresh or marine water

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depending on kind of aquatic ecosystem where discharge is intended. At least one system
with high organic matter/nutrient content and one with low organic matter/nutrient
content should be tested (see above)

A study on aerobic transformation of low concentrations of organic contaminants

according to OECD guideline 309 (Aerobic Mineralization in Surface Water - Simulation
Biodegradation Test) or equivalent guidelines, using fresh or marine water depending on
the kind of aquatic ecosystem where discharge is intended

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

(1998) and/or OECD Guidance document on phototransformation in water (1997)]
Active substance
Information on other components
Relevant chemicals
3.4.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient
Testing should include:

Data on bioconcentration and biomagnification, which have already been detailed earlier
in this document

A study into the log Pow according to OECD guideline 107 [Partition Coefficient
(n-octanol/water): Shake Flask Method] or equivalent test guidelines. For very hydrophobic
compounds a slow stirring method is required:

The partition coefficient between solids and liquids should be determined [e.g. according
to EU Technical Guidance Document on Risk Assessment (2003) for at least three
inocula, including freshwater sediment, marine sediment, and particulate matter (sludge)].

If no measured data are available for a specific adsorbing material, it is assumed that all
adsorption can be related to the organic matter of the medium, viz. standardization to Koc. This is
only valid for non-ionic substances. For ionic substances the Kp values and the test characteristics
(%clay, CEC, %o.c., pH) should be reported.
Active substance
Partition coefficient n-octanol/water including effect of pH (5 to 9) and temperature
Information on other components
Relevant chemicals
3.4.3

Persistence and identification of the main metabolites in the relevant media (ballast
water, marine and fresh waters)
The route of degradation in the tests required under section 3.4.1 of this document is to be
characterized, based on a mass balance including mineralization and formation of bound residue.
Metabolites formed in relative amounts of >5% of the initial dose at any point in time are to be
identified. For relevant chemicals the application shall contain all data as specified before, since
they are subject to the decision making criteria.
Active substance
Information on other components
Relevant chemicals
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3.4.4 Reaction with organic matter

The reaction of active substances that are radical producing agents, with organic matter shall be
addressed qualitatively as to identify products of concern to the environment. Radical producing
chemicals are capable of forming halogenated (chlorinated, brominated) hydrocarbons which
may be of concern to environmental or human health, in the presence of organic matter. For these
substances, the freely and otherwise reasonably available information should be presented and
discussed in relation to the proposed manner of application, since they are subject to the decision
making criteria.
Active substance
Information on other components
Relevant chemicals
3.4.5 Potential physical effects on wildlife and benthic habitats
Data requirements consist of physical-chemical properties also required later. Further guidance
can be found in the MEPC approved hazard evaluation procedure published as GESAMP Reports
and Studies No. 64.
Preparation
Active substance
Information on other components
Relevant chemicals
Ballast water
3.4.6 Potential residues in seafood
As appropriate, data shall be submitted to assess the risk that residues of the active substance end
up in seafood, the possible impact on consumer safety and the level of residues that may be
tolerated in seafood. Any available monitoring data on residues of the substance in seafood shall
be submitted.
Preparation
Active substance
Information on other components
Relevant chemicals
3.4.7 Any known interactive effects
Any knowledge (or absence of this knowledge) on interactive effects of the Relevant Chemicals
with the ballast water, with other preparations to be used in ballast water, with other physical or
chemical management of the ballast water, or with the receiving environment, should be
reported.
Active substance
Information on other components
Relevant chemicals
3.5
Physical and chemical properties for the active substances and preparations and
treated ballast water, if applicable (G9: 4.2.1.5)
Data are necessary for the Active Substances, their preparations, the treated ballast water on
board and the Relevant Chemicals discharged to allow for the identification of hazards for the
crew, the ship and the environment.
3.5.1 Melting point
Preparation
Active substance
Information on other components
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3.5.2 Boiling point

Preparation
Active substance
Information on other components
3.5.3 Flammability (flash point)
Preparation
Active substance
Information on other components
3.5.4 Density (relative density)
Preparation
Active substance
Ballast water
3.5.5 Vapour pressure, vapour density
Preparation
Active substance
Information on other components
3.5.6 Water solubility/dissociation constant
Active substance
Water solubility and effect of pH (5 to 9) and temperature on solubility where relevant
Dissociation constant (pKa)
Information on other components
Relevant chemicals
Water solubility and dissociation constant
3.5.7 Oxidation/reduction potential
Preparation
Active substance
Ballast water
also redox for ballast water used in type approval testing
3.5.8 Corrosivity to the materials or equipment of normal ship construction
Preparation
Active substance
Information on other components
Relevant chemicals
Ballast water
3.5.9 Autoignition temperature
Preparation
Active substance
3.5.10 Explosive properties
Active substance
3.5.11 Oxidising properties
Preparation
Active substance
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3.5.12 Surface tension

Preparation
Active substance
3.5.13 Viscosity
Preparation
Active substance
3.5.14 Thermal stability and identity of relevant breakdown products
Active substance
3.5.15 Reactivity towards container material
Preparation
Active substance
3.5.16 pH
Preparation
Ballast water used in type approval testing
3.5.17 Salinity
Ballast water used in type approval testing
3.5.18 TOC, DOC, % particulate matter
Ballast water used in type approval testing
3.5.19 Other known relevant physical or chemical hazards
Preparation
Active substance
Information on other components
Relevant chemicals
Ballast water
3.6

Analytical methods at environmentally relevant concentrations (G9: 4.2.1.5)

3.6.1 Analytical methods at environmentally relevant concentrations

Preparation
Active substance
Analytical methods for the detection of Active Substances in discharge water and sediment, at
environmentally relevant concentrations, are required. The methods including sampling should
be proven to be workable.
Relevant chemicals
Analytical methods for the detection of Relevant Chemicals in discharge water and sediment, at
environmentally relevant concentrations, are required. The methods including sampling should
be proven to be workable.
4

Use of the Preparation

4.1
The manner of application
The proposal should include the manner of application of the preparation for the Ballast Water
Management (BWM), including required dosage and retention time (G9: 4.2.6).
In relation to point 7 of the Procedure, the dossier should contain the necessary data addressing
the following items:
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The technical manual or instructions by the manufacturer, including the product

specification, process description, operational instructions, details of the major
components and materials used, technical installation specifications, system limitations,
and routine maintenance should be provided (BWWG), including quantity to be added to
ballast water and maximum concentration of the active substance therein.

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

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

gases etc.

Emergency measures in case of an accident

Possibility of destruction or decontamination following release in the marine environment

Procedures of waste management of the active substance

Possibility of reuse or recycling

Possibility of neutralization

Conditions for controlled discharge

Amount of substance on board ship

Risk management (e.g. for neutralization of the Active Substance in case of emergency or if
PEC/PNEC at discharge >1) should be described. These management measures are an integral
part of the Ballast Water Management System and should be evaluated in the assessment of the
ballast water discharge.
The risk management measures proposed should be evaluated in respect to the hazards to ship,
personnel and the environment.
5

Material Safety Data Sheets (G9: 4.2.7)

With respect to classification of hazards, a detailed technical guidance document has been
prepared for the United 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 applicant is referred to this document for a more detailed guidance on
hazard identification.
For the preparation, each active substance, each hazardous component, and each Relevant
Chemical, the classification under the GHS, and a Material Safety Data Sheet (G9: 6.3.2) should
be provided by the applicant. Key data for these should be summarised in the Key Data Summary
Table.
6

Risk Characterisation

6.1

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

6.1.1 Persistence (G9: 5.1.1.1)

Persistence is preferably assessed in simulation test systems to determine the half-life under
relevant conditions. Biodegradation screening tests may be used to show that the substances are
readily biodegradable. The determination of the half-life should include assessment of relevant
chemicals.
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For persistence and degradation data requirements, see 2.4.1 and 2.4.3 of this document.
6.1.2 Bioaccumulation (G9: 5.1.1.2)
The assessment of bioaccumulation potential should use measured bioconcentration factors in
marine (or freshwater organisms). Where tests are not applicable, or log Pow <3, the
bioconcentration factor may be estimated using structure activity relationships (SAR).
For bioaccumulation data requirements, see 2.2.5 and 2.4.2 of this document.
6.1.3 Toxicity tests (G9: 5.1.2.3)
Acute and/or chronic ecotoxicity data, ideally covering the sensitive life stages, should be used
for the assessment of the toxicity criterion.
For ecotoxicity data requirements, see 2.2 of this document.
It is necessary to consider, whether an effect assessment based on tests in freshwater species
offers sufficient certainty that sensitive marine species will be covered by any risk assessment.
6.1.4 Does the active substance and/or preparation meet all three criteria for PBT?
See G9: Table 1
Table 1

PBT criteria

Persistence

Half-life:
> 60 days in marine water, or
> 40 days in freshwater,a or
> 180 days in marine sediment, or
> 120 days in freshwater sedimenta
If Log Poctanol/water 3, then experimental
BCF required.
BCF > 2,000
Chronic NOEC < 0.01 mg/l

Bioaccumulation

Criteria for identification of PBT substances

Criterion

Toxicity

For the purpose of marine environmental risk assessment half-life data in freshwater and freshwater sediment can be
overruled by data obtained under marine conditions.

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

the Procedure shall not be approved.
6.2

Evaluation of the treated ballast water (G9: 5.2)

The advantage of toxicity testing on the ballast water discharge is that it integrates and addresses
the potential by-products of the formulation and interactions with the system.
6.2.1 Basic approval
Testing should be performed in laboratory (G9: 5.2.1)
6.2.2 Final approval
Discharge test with whole system (G9: 5.2.2).
In accordance with Regulation D-3.2, a Ballast Water Management system using an Active
Substance or Preparation to comply with the Convention (which received basic approval) must
be approved by the Organization. For this purpose, the Member of the Organization submitting
an application should conduct the Type Approval tests in accordance with Guidelines for
Approval of Ballast Water Management Systems. The results should be conveyed to the
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Organization for confirmation that the residual toxicity of the discharge conforms to the
evaluation undertaken for Basic Approval. This would result in Final Approval of the Ballast
Water Management system in accordance with Regulation D-3.2. Active Substances or
Preparations that have received Basic Approval by the Organization may be used for evaluation
of Ballast Water Management systems using Active Substances or Preparations for Final
Approval (G9: 8.2.1).
6.2.3 Determination of holding time
The test data should be used to determine the no adverse-effect concentration upon discharge.
The half-life, decay and dosage rates, system parameters and toxicity should be used to determine
the amount of time needed to hold the treated ballast water before discharge (5.2.7). An
indication of the uncertainty of the holding time should be given, taking into account variables
(e.g. temperature, pH, salinity and sediment loading).
6.3

Risk characterisation and analysis

6.3.1 Reaction with organic matter (see G9: 4.2.1.3; this report 2.4.4)
The reaction with organic matter of active substances and preparations that produce free radicals
should be addressed qualitatively, so as to identify products of concern to the environment.
6.3.2 Characterisation of persistence (G9: 5.3.5)
The route of abiotic and biotic degradation of the Active Substances and Preparations under
aerobic and anaerobic conditions (see 2.4.1 above) should be assessed, resulting in the
characterization of the persistence of the Active Substances, Preparations and Relevant
Chemicals in terms of degradation rates under specified conditions (e.g. pH, redox, temperature).
6.3.3 Prediction of discharge concentrations
Based on the information on fate and behaviour of Active Substances and Preparations, the
discharge concentrations at selected time intervals should be predicted (G9: 5.3.8).
6.3.4 Assessment of potential for bioaccumulation
For Active Substances and Preparations, the potential for bioaccumulation should be assessed in
marine or freshwater organisms (fish or bivalves) if the logarithm octanol/water partition
coefficient (log Pow) is >3 (G9: 5.3.7).
6.3.5 Effects assessment
The effect assessment of the Active Substances, Preparations and Relevant Chemicals is initially
based on a dataset of acute and/or chronic ecotoxicity data for aquatic organisms, being primary
producers (algae or sea grasses), consumers (crustaceans), predators (fish), and should include
secondary poisoning to mammalian and avian top-predators, as well as data for sediment species
(G9: 5.3.9).
In the effect assessment only toxicity studies reporting on dietary and oral exposure are relevant,
as the pathway for secondary poisoning refers exclusively to the uptake of chemicals through the
food chain. It is necessary to extrapolate threshold levels for marine species from terrestrial
species assuming there are interspecies correlations between laboratory bird species and marine
predatory bird species and between laboratory mammals (e.g. rats) and the considerably larger
marine predatory mammals.
An assessment of secondary poisoning is redundant if the substance of concern demonstrates a
lack of bioaccumulation potential (e.g., BCF < 500 L/kg wet weight for the whole organism at
6% fat) (G9: 5.3.10).
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An assessment of sediment species is redundant if the potential of the substance of concern to

partition into the sediment is low (e.g., Koc < 500 L/kg) (G9: 5.3.11).
The effect assessment of the Active Substances, Preparations and Relevant Chemicals, taking the
indicated information into account, should be based on internationally recognized guidance
(e.g. OECD) (G9: 5.3.13).
Health effects in humans
The effect assessment of the Active Substances, Preparations and Relevant Chemicals should
include a screening on carcinogenic, mutagenic and endocrine disruptive properties. If the
screening results give rise to concerns, this should give rise to a further effect assessment (G9:
5.3.12).
Effects on aquatic organisms
Considering the deliberate discharge of Active Substances and/or relevant chemicals into the
environment, where only data for algae, crustaceans and fish is available, for the derivation of a
predicted no effect concentration in salt water (PNECsaltwater) a higher assessment factor than that
for the derivation of predicted no effect concentration in fresh water (PNECfreshwater) should be
applied, to reflect the greater uncertainty in protecting sensitive species in saltwater
environments. Where data is available for additional taxonomic groups, for example rotifers,
echinoderms or molluscs, the uncertainties in the extrapolation are reduced and the magnitude of
the assessment factor applied to a dataset can be lowered. For naturally occurring Active
Substances not meeting PBT-Criteria and being rapidly degradable, the PNEC could be set along
the background concentration in the environmental compartment under consideration. Both acute
and chronic data on algae, crustaceans and fish are required by the Procedure; however, because
of their greater relevance for the situation at hand, only assessment factors based on chronic
effects are considered. There are some circumstances where expert judgment may be applied to
the interpretation of a dataset which may allow a pragmatic approach to the application of the
assessment factors and the generation of new data. In each case where expert judgment is so
applied, a full justification must be provided.
Table 2 Effect assessment for deriving PNECs for freshwater and saltwater
Data set

Assessment factor

Freshwater assessment

Lowest chronic NOEC from three freshwater or saltwater 10

species representing three trophic levels
Saltwater assessment

Lowest chronic NOEC from three freshwater or saltwater 100

species representing three trophic levels
Lowest chronic NOEC from three saltwater species [10, 100]
representing three trophic level
Lowest chronic NOEC from three freshwater or saltwater 10
species representing three trophic levels + at least two
chronic
NOECs
from
additional
marine
taxonomic groups
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Effects on sediment
Because sediment constitutes an important compartment of ecosystems it may be important to
perform an effects assessment for the sediment compartment for those substances that are likely to
transfer substantially into the sediment. Most of the existing whole sediment tests measure acute
toxicity; only a few measure long-term, sub-lethal endpoints. Only the latter tests are considered
applicable to risk assessment because of the long-term exposure of benthic organisms to sedimentbound substances that occur under field conditions. Due to the generally long-term exposure of
benthic organisms to sediment-bound substances, long-term tests with sub-lethal endpoints like
reproduction, growth, emergence, sediment avoidance and burrowing activity are regarded as most
relevant. It is recommended to use pooled marine and freshwater sediment toxicity data for effect
assessment for the sediment compartment. However, when sufficient data for ecologically relevant
saltwater species are available, lower assessment factors can be applied. Since there are no chronic
marine sediment test methods that are internationally accepted the results from any tests should
always be evaluated with caution.
Table 3 Effect assessment for deriving PNECs for sediment
Data set

Assessment factor

Freshwater assessment
Three chronic sediment tests with species representing
different living and feeding conditions

10

Saltwater assessment
Three chronic sediment tests with species representing
different living and feeding conditions
Lowest chronic NOEC from three freshwater or saltwater
species representing different living and feeding conditions
including at least two chronic NOECs from marine species

50
10

6.3.6 Comparison of effect assessment with discharge toxicity

The results of the effect assessment are compared to the results of the discharge toxicity testing. Any
unpredicted results (e.g., lack of toxicity or unexpected toxicity in the discharge assessment) should
give rise to a further elaboration on the effect assessment (G9: 5.3.14).
Predicted environmental exposure and possible effects
For the purposes of the initial analysis referred to in point 5.2.6. of the Procedure, the ratio of the
predicted exposure concentration of Active Substances or relevant chemicals in the treated ballast
water at discharge and the predicted no effect concentration should be equal to or below 1
(PEC/PNEC 1). If this condition is fulfilled, use of the Active Substance or preparations for ballast
water treatment and subsequent discharge are acceptable without further consideration.
However, it should be noted that due to dilution after discharge of treated ballast water, the predicted
exposure concentration within the water compartment will be lower in the local environment (e.g.
port area) and may be significantly lower in the marine and the coastal environment. In addition, the
PEC after discharge might be reduced by appropriate risk management measures, e.g. by the use of a
neutralizing agent for remaining Active Substances or preparations. Therefore, a predicted
PEC/PNEC ratio greater than 1 (PEC/PNEC >1) in the ballast water at discharge may eventually be
acceptable, if it is established in the risk assessment that under field conditions no unacceptable
impact, either directly or indirectly, occurs on the viability of exposed organisms, including marine
and estuarine organisms, due to the discharge of ballast water treated with systems making use of
Active Substances or preparations.
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All models and assumptions to derive a predicted exposure concentration within the water
compartment after discharge should be stated (e.g. the effects of risk mitigation measures,
quantities discharged, size of the receiving compartment, dilution factors, distribution etc. the
OECD Emission Scenario Document for Antifouling Paints and other publicly available
Technical Guidance Documents might be suitable starting points).
When no quantitative risk characterization can be carried out, for example for marine areas or
when a PEC or PNEC cannot be properly derived, a qualitative risk characterization should be
conducted.
Risks to human health
The human health risk assessment should follow generally accepted guidelines including acute
and long-term exposure situations. The risk assessment shall entail hazard identification and, as
appropriate, dose (concentration) response (effect) assessment, exposure assessment and risk
characterization. The population groups at risk to be examined should include crew, passengers,
as well as personnel and the public in ports. Potential health risks connected to the exposure of
consumers via seafood or persons at the coast (e.g. beach) after discharge should be evaluated.
Special attention should be given to service and repair of the system by technicians and
accidental situations on board (e.g. specific personal protection equipment). The evaluation of the
risks to human health should include risk reduction (risk management) by regulations based on
the SOLAS Convention as well as specific measures proposed by the manufacturer of the Ballast
Water Management System.
7

Assessment report (G9: 4.3)

7.1

Quality of the test reports (G9: 4.3.1)

7.2

Risk characterisation

7.3
Consideration of the uncertainty associated with the assessment
The Assessment report referred to in point 4.3 of the Procedure shall at least provide:

An overview of the data and endpoints on which the risk characterization according to
section 6 of the Procedure is based
A risk characterization for the environment, human health, property (e.g. ship) or
resources (e.g. fisheries) in accordance with section 6 of the Procedure
If any monitoring has been conducted, a summary of the results of that monitoring,
including information on the analytical methodology used, ship movements and a general
description of the area monitored
A summary of the available data on environmental exposure and any estimates of
environmental concentrations developed through the application of mathematical models,
using all available environmental fate parameters, preferably those which were
determined experimentally, along with an identification or description of the modelling
methodology
An evaluation of the association between the Ballast Water Management System making
use of Active Substances or preparations containing one or more Active Substances to
comply with the Convention in question, the related adverse effects and the
environmental concentrations, either observed or expected based on the risk assessment
and the effluent testing
A qualitative statement of the level of uncertainty in the evaluation referred to under the
preceding paragraph
A detailed description of risk management possibilities, e.g. for neutralization of the

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Active Substance in case of emergency or if PEC/PNEC at discharge >1. These

management measures are an integral part of the Ballast Water Management System.
8

Modification to the application

Manufacturers should report any modifications in names, including trade and technical name,
composition or use of the Active Substances and Preparations in the Ballast Water Management
systems approved by the Organization, to the Member of the Organization. The Member of the
Organization should inform the Organization accordingly (G9: 8.4.1).
Manufacturers intending to significantly change any part of a Ballast Water Management System
that has been approved by the Organization or the Active Substances and Preparations used in it
should submit a new application (G9: 8.4.2).
9

Final approval

Further guidance on methodology and testing and sampling for final approval to be added.

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APPENDIX

Key Data Summary Form for the 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
(eg CAS number)

Percentage
(indicating
units,
eg
w/w, g/l)

Active substance
1. Other component
2. Other component
3. Other component, etc.
Identification of any relevant chemicals (IUPAC name, CAS number):
Section 2:
Effects on aquatic organisms (G9: 4.2.1.1)
Acute aquatic toxicity
Test substance

Preparation
Active substance
Other components
(1, 2, 3)

Species
(eg
fish, Daphnia,
algae)

Effect (L(E)C50;
duration)

Value (units);
range

Reference/
comments

1.
2.
3.

Relevant
chemicals
Ballast water
Other
Data waivers for acute aquatic toxicity
Species

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Test substance

Test

Reason for not

supplying the data

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Chronic aquatic toxicity

Test substance

Species
(eg
fish, Daphnia,
algae)

Effect
(NOEC;
duration)

Value (units);
range

Reference/
comments

Preparation
Active substance
Other components 1.
(1, 2, 3)
2.
3.
Relevant
chemicals
Ballast water
Other
Data waivers for chronic aquatic toxicity
Species

Test substance

Test

Reason for not

supplying the data

Information on endocrine disruption

Substance

Information on endocrine disruption

Preparation
Active substance
Other components
(1, 2, 3)
Relevant chemicals
Other
Sediment toxicity
Test substance

Species (eg fish,

Daphnia, algae)

Effect [L(E)C50;
duration; NOEC]

Value (units);
range

Reference/
comments

Preparation
Active substance
Other
1.
components (1, 2, 2.
3)
3.
Relevant
chemicals
Ballast water
Other
Data waivers for sediment toxicity
Test substance

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Species

Test

Reason for not

supplying the data

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Bioavailability/biomagnification/bioconcentration
Substance

Log Pow

BCF

Cause
for
concern
(yes/no)

Reference/Comments

Active substance
Other components 1.
(1, 2, 3)
2.
3.
Relevant
chemicals
Other
Food web/population effects
Substance

Cause for
concern
(yes/no)

Comments

Active substance
Other components 1.
(1, 2, 3)
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)

Preparation
Active
substance
Other
components
(1, 2, 3)
Relevant
chemicals
Other

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1.
2.
3.

Reference/
Comments

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Skin Irritation
Substance

Species

Method
guidelines

Average
score (24,
48, 72 h)

Reversability
(yes/no)

Result

Reference/
Comments

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

Preparation
Active
substance
Other
components
(1, 2, 3)

1.
2.
3.

Relevant
chemicals
Other
Skin sensitization
Substance

Species

Preparation
Active substance
Other components 1.
(1, 2, 3)
2.
3.
Relevant
chemicals
Other

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Method
guidelines
(Buehler,
M&K)

Sensitiser
(y/n)

Reference/Comments

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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
1.
components (1, 2, 2.
3)
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;

Reference/
Comments

NOAEL parental;
NOAEL F1; NOAEL
F2
(units); range

Preparation
Active substance
Other components 1.
(1, 2, 3)
2.
3.
Relevant
chemicals
Other
Data waivers for developmental and reproductive toxicity
Test substance

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Test; species; route

of exposure

Reason for not supplying the data

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Carcinogenicity
Substance

Species

Method
guidelines

Route; Duration;
doses;
frequency of
application

Effects;
NOAEL;
NOEL (units)

Reference/
Comments

Preparation
Active substance
Other
components
(1, 2, 3)

1.
2.
3.

Relevant
chemicals
Other
Data waivers for carcinogenicity
Test substance

Test; species; route

of exposure

Reason for not supplying the data

Mutagenicity/genotoxicity
Substance

Species
(In vitro or
in vivo)

Method
guidelines

With/witho
ut
activation;
duration;
concentrati
ons tested

Results
(positive/
negative)

Reference/Com
ments

Preparation
Active substance
Other components 1.
(1, 2, 3)
2.
3.
Relevant
chemicals
Other
Data waivers for mutagenicity/genotoxicity
Test substance

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Test; Species; route

of exposure

Reason for not supplying the data

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Section 4:
Data on environmental fate and effect under aerobic and anaerobic
conditions (G9: 4.2.1.3)
Modes of degradation (biotic; abiotic)
Hydrolysis at pH 5, 7, 9
Test substance

Test;
duration

Active substance
Other components
(1, 2, 3)

pH;
temp

Value (units); half life

Reference/
comments

1.
2.
3.

Relevant chemicals
Other
Data waivers for hydrolysis
Test substance

Test

Reason for not supplying the data

Biodegradability
Test substance

Active substance
Other components
(1, 2, 3)

Test type;
duration;
sea/freshwat
er

Readily
biodegradabl
e (y/n)

Value (units);
half life

Identification
of
breakdown
products

Reference/
comments

1.
2.
3.

Relevant
chemicals
Other
Data waivers for biodegradation
Test substance

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Test

Reason for not supplying the data

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Partition coefficients
Test substance

Active
substance
Other
components
(1, 2, 3)
Relevant
chemicals
Other

Coefficient
(Pow; Koc;
other)

Test method;
pH; temp

Value (log units)

Reference/
comments

1.
2.
3.

Data waivers for partition coefficients

Test substance

Test

Reason for not supplying the data

Persistence and identification of the main metabolites

Test substance

Active substance
Other components
(1, 2, 3)

Test;
duration

pH;
temp

Value (units); half life

Reference/
comments

1.
2.
3.

Relevant chemicals
Other
Data waivers for persistence and identification of the main metabolites
Test substance

Test

Reason for not supplying the data

Reaction with organic matter

Test substance

Active substance
Other components
(1, 2, 3)
Relevant chemicals
Other

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Discussion of the reaction, including

formation of hazardous byproducts

1.
2.
3.

Reference/
comments

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Potential physical effects on wildlife and benthic habitats

Test substance

Physical
description
(state,
solubility,
viscosity)

Discussion of potential effects

Reference/
comments

Impact on consumer safety

Reference/
comments

Discussion of potential effects

Reference/
comments

Preparation
Active substance
Other components 1.
(1, 2, 3)
2.
3.
Relevant chemicals
Ballast water
Other
Potential residues in seafood
Test substance

Preparation
Active substance
Other components
(1, 2, 3)

Monitoring
data/residues

1.
2.
3.

Relevant chemicals
Other
Any known interactive effects
Test substance

Active substance
Other components
(1, 2, 3)
Relevant chemicals
Ballast water
Other

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Interaction
with other
chemicals,
BWS, or
receiving
environment

1.
2.
3.

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Physical and chemical properties for the active substances and preparations and treated ballast
water, if applicable (G9: 4.2.1.5)
Property (with units
and reference)

Melting point (C)

Boiling point (C)
Flammability (flash
point for liquids;
C)
Density (20 C;
kg/m3)
Vapour
pressure
(20 C; Pa)
Vapour density (air
= 1)
Water
solubility
(temp; effect of pH;
mg/l)
pH in solution
Dissociation
constant (log Koc)
Oxidationreduction potential
Corrosivity
to
material
or
equipment
Reactivity
to
container material
Autoignition
temperature (C)
Explosive
properties
Oxidising
properties
Surface tension
Viscosity
Thermal stability
and identity of
breakdown
products
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Preparati
on

Active
substance

Other
components
(1, 2, 3)

1.
2.
3.
1.
2.
3.
1.
2.
3.
1.
2.
3.
1.
2.
3.
1.
2.
3.
1.
2.
3.
1.
2.
3.

Relevant
chemicals

Ballast
water

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chemical properties

GESAMP-BWWG 1/9

1.
2.
3.

Shaded cells, data not required

Salinity, TOC, DOC, and % particulate matter are required for the ballast water used in type approval testing.

Analytical methods at environmentally relevant concentrations (G9: 4.2.1.5)

Substance

Analytical method; conditions;

applicability (water/sediment)

Sensitivity

Reference/
comments

Preparation
Active substance
Relevant chemicals
Other
Use of the preparation
Brief description of the handling storage and use:
Material safety data sheets
Substance

Provided
(yes/no)

Classification according to GHS

Reference/
comments

Bioacumulative
(y/n)

Reference/
comments

Preparation
Active substance
Other components 1.
(1, 2, 3)
2.
3.
Other
Risk characterisation
Substance

Persistent (y/n)

Toxic (y/n)

Preparation
Active substance
Other
1.
components (1, 2, 2.
3)
3.
Relevant
chemicals
Other
Evaluation of the treated ballast water
Conclusion of the half-life of the toxicity of the treated ballast water, and the recommended
holding time.
Risk characterisation
Conclusion on the effects of reaction with organic matter
Conclusion of persistence
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Conclusion on the discharge concentration

Conclusion on the potential for bioaccumulation
Conclusions on the effects assessment
Human health
Aquatic organisms
Sediment
Conclusion of the comparison of effect assessment with discharge toxicity

***

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ANNEX 5
REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES SUBMITTED BY GERMANY
(PERACLEAN OCEAN)
The basis for the groups evaluation of PERACLEAN OCEAN was the application
dossier submitted by Germany. No further data sources were consulted.
1

Completeness of the dossier

The application dossier is not considered to be complete as the following information is missing:

A detailed description of the intended application on-board ships allowing full evaluation
of the safety to ship and crew
Data on realistic occupational exposure scenarios are required in order to characterize
human health risk of use and handling.
Justification for use of scenarios for modelling environmental exposure concentrations
Tests with treated Ballast Water on more species, including long-term data
Justification for non-submission of data
Identity

Preparation data
PERACLEAN OCEAN consists of the following components (approximate concentrations):

Peracetic acid (PAA) [79-21-0]

Hydrogen peroxide [7722-84-1]
Acetic acid [64-19-7]
Water

H3CC(=O)-O-OH
HOOH
CH3-COOH
H2O

14 - <17%
13 - <15%
24 - <29%
<39 - 49%

Peracetic acid is the Active Substance, which is in a dynamic equilibrium with hydrogen
peroxide in both the formulated preparation and in ballast water during use. Peracetic acid is a
strong oxidising agent with a non-specific mode of action.
PERACLEAN OCEAN is specified as scheduled in the IMDG Code under UN No. 3109,
organic peroxide Type F, liquid, with a classification of 5.2.

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Physicochemical properties
Property
Molecular weight
Physical state
Melting point [C]
Boiling point [C]
(Relative
)density
[kg/m3]
Vapour pressure [Pa]
Solubility [g/L]
Log Kow
pKa
Viscosity
Henrys law constant
Flash point [C]
Autoignition temperature
[C]
Flammability
Explosive properties
3

PAA

H2O2

Acetic acid
60
Clear, colourless liquid
-16
100
1050

76.05
Clear, colourless liquid
-50
> 60
1150

34.02
Clear, colourless liquid
-0.40
150 (d)
1442.5

1.1 10-5
1000
-0.52
8.2

300
Miscible
-1.5
11.62

1570
Miscible
-0.23

5 10-12
96
265

4.5 10-6

5.4 10-4
40
485
Flammable
Not explosive

Application

The recommended application of PERACLEAN OCEAN is a concentration of 150 mg/L in the

ballast water for a minimum period of 1 day and for preferably a period of 2 days.
The submission informs PERACLEAN OCEAN is applied to the ballast water by an automated
dosing system that addresses the variations in flow rates of ballast pumps. The product is dosed
after a two stage filtration process designed for pre-separation of solids above 50 m.
4

Human health hazards

PERACLEAN OCEAN is a preparation used for Ballast Water disinfection whose biocidal
activity is based on peroxygen mechanism due mainly to the physical-chemical properties of the
peracetic acid (PAA) and hydrogen peroxide. Whenever possible, and preferably, the
toxicological evaluation should be based on the evaluation of the preparation test results.
Hazard classification for PAA at 15% as in the Annex I to Dir 67/548/EEC:
C; R20/21/22-35
It is a severe corrosive to skin and eyes, harmful by inhalation, if swallowed, and in contact with
skin. Irritant to mucous membranes of the respiratory tract.
Hazard classification for H2O2 at 14.3% as in the Annex I to Dir 67/548/EEC:
Xn; R22-41
It is considered harmful if swallowed and a there is a risk of serious damage to eyes.
Classification information reflects hazard and does not take account of potential exposure.
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Acute toxicity
Route of exposure
Oral
(15% PAA)
Dermal
(15% PAA)
Inhalation, aerosol

LD 50 or LC50
1021 mg/kg bw

Species
Rat

Reference
Degussa, 1982

1957 mg/kg bw

Rabbit

Kuhn, 1996

Ca 0.5-1.3 mg/L/4h Rat

Terrell, 1986

The test results mentioned in the presented studies confirm that the preparation is harmful by oral
and dermal routes and it is considered toxic by inhalation. However, the Group agreed to take
into consideration that, as PAA is highly unstable, there were difficulties in generating a stable
atmosphere and therefore accurate measurements of the test atmosphere and droplets of aerosol
were difficult to achieve. In these circumstances, LC50 value should be used with caution.
During the observation periods from the referred studies the commonly reported adverse effects
were related to irritation of skin (dermal route) and to mucous membranes either from the
gastrointestinal tract (oral route) or the respiratory tract (inhalation route). The clinical and
pathological signs were presumably associated with these inflammatory reactions. According to
the reports, these effects were considered to be local (near the point of contact), depending on the
concentration applied, and not inducing systemic toxicity.
Additionally, in a dermal acute study (Kuhn 1996), reported signs of toxicity (nasal discharge)
could be attributed to systemic effects at high dose levels. However, it is likely that in this
particular study these signs were caused by additional inhalation exposure.
It is considered that PAA due to its intrinsic physical-chemical properties log P<0, high water
solubility and high hydrolysis rates at pH near 7 (body pH) - and in case of damaged skin, can
efficiently diffuse through the internal membranes and be absorbed in the cells. This process is
assumed not to induce target organ toxicity, perhaps with exception of stomach where pH is
around 2 and PAA can be stable nor bioaccumulate as the parent compound will rapidly be
absorbed, distributed in the body fluid and metabolized by catalases into HOAc and H2O and
O2, being further eliminated by the different routes (urine, faeces and exhaled air).
Effects on skin and eye
Skin irritation
A study was performed according to OECD TG 404 to address skin irritation (Degussa, 1990).
After one single application of 0.5 ml PAA 15% in skin rabbit, 4 h of occlusive exposure, the
results were indicative of severe corrosiveness.
Skin sensitization
No skin sensitization was observed in two Buhler tests in guinea pigs with different formulations
of PAA (5% and 12%). In one guinea pig maximisation test, a positive result was claimed but the
report does not permit critical evaluation of the results (ECETOC JACC N 40, 2001).

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Eye irritation
A study from Cascieri and Freeman (1983) was submitted by the applicant to address this
endpoint, where 17% PAA was tested in rabbit eyes and found to be extremely irritant to washed
and unwashed eyes. A classification of severe irritant was determined.
Irritation to the respiratory tract
An acute inhalation test was performed by Janssen (1989) to investigate irritating properties of
nebulised PAA 15%. The RD50 referring to a concentration of PAA inducing a 50% reduction of
respiratory rate was calculated to be 21.5 to 24.1 mg/m3. After exposure the respiratory rates
returned to normal and the animals recovered fully within 3 days. No other clinical signs and no
histopathological changes were observed.
Repeated Dose Toxicity
An oral sub-chronic study (90 d) in rats with PAA 5% (CEFIC, PAR, 2003).was submitted by the
applicant in order to investigate the toxic effects resulting from repeated dose administration.
Clinical and histopathological data suggest local acute irritant effects on trachea and lungs
attributed to gavage administration rather than systemic effects. The findings are in accordance
with the toxicokinetics weight of evidence and support that PAA will not be systematically
available beyond the site of first contact.
According to the test conditions, a NO(A)EL (no observed adverse effect level) at 5 mg/kg
bw/day was identified based on local irritant effects. By extrapolation, this value would
correspond approximately to 1.7 mg/kg bw/day of PAA 15%. Applying an assessment factor of
100 for intra- and interspecies variability, a NO(A)EL (humans) of 0.017mg/kg bw/day could be
estimated. However, due to deficiencies relating to the stability of the test substance during the
experimental period and to the uncertainty inherent to extrapolation calculations, this value
should be considered with caution.
Several sub-chronic studies mentioned in the literature report effects arising from oral, dermal or
inhalation exposure to PAA that seem to be related with local irritation at the site of contact.
However, some systemic effects on liver, kidney and perhaps spleen (significative differences in
white blood cells counting) cannot be ruled out and therefore no clear NAEL can be derived from
available studies (ECETOC JACC, N40).
From the overall assessment of acute and sub-chronic effects, it should be recommended that the
irritation effects in the respiratory tract triggered in some inhalation studies (Janssen, 1989;
Janssen and Van Doorn, 1994) should be further investigated in a repeated dose inhalation study
in order to assess the toxicity of the substance at lower dose exposure. Additionally, a dermal
absorption study in vitro with non damaged skin at lower doses (diluted concentrations) should
be conducted to anticipate the risk of occupational exposure in non accidental situations.
Mutagenicity/Genotoxicity
The evaluation of the battery of genotoxic and mutagenic tests submitted by the applicant,
coming from literature search and using different concentrations (%) of the test substance, gives
limited information on the effects of PAA on DNA and its potential to induce gene and
chromosome mutations both in vivo and in vitro. Several bacterial tests were presented but due to
cytotoxic effects at higher doses resulting from the biocidal nature of PAA, these are of limited
value for appraisal of these effects. However, as a general conclusion the Group can accept at this
stage that PAA doesnt show a significant potential concern for mutagenicity/genotoxicity.
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Chronic and long term toxicity, developmental and reproductive toxicity, carcinogenicity
The applicant submitted a justification for non-submission of the following studies:

sub-chronic toxicity study with a second species

chronic toxicity study
developmental and reproductive study
carcinogenicity study

The argument presented in the justification for non-submission was the fact that by testing PAA
was proven to be not systemically available and therefore unable to reach specific organs.
This justification can be accepted at this stage based on specific toxicokinetics and also the fact
that there is limited reliable information available concerning the testing of these endpoints
(chronic or carcinogenicity studies, teratogenic and multigeneration studies), and doesnt allow a
critical assessment of the potential for toxicity of these health effects (ECETOC JACC, N 40,
2001).
5

Risks to safety of ship and crew

The submission states that PERACLEAN OCEAN is safe to the ship and crew during normal
operation provided the manufacturers procedures are followed. As the dosing is fully automated,
no crew handling of the chemical is required. However, due to the inherent dangerous properties
of PERACLEAN OCEAN in its undiluted form many different safety measures are essential to
reduce risks to a level that may be acceptable and permit its use on-board ship.
PERACLEAN OCEAN is classified as corrosive and oxidizing. Under the influence of heat or
catalytically active substances it is liable to rapid exothermic decomposition and decomposes into
water, acetic acid, and oxygen. If ingested or inhaled it has a severe caustic effect. In contact
with the skin or eyes it is considered severely corrosive. It reacts on contact with iron, copper,
brass, bronze and zinc and may react with organic substances causing fire. It must not be
brought into contact with combustibles, greases, or oils. It must be protected from direct sunlight
and stored away from all sources of heat in a well ventilated area.
PERACLEAN OCEAN is recommended to be stored in free-standing firmly installed tanks of
volume up to 50m3 constructed of special grade stainless steel, or in exchangeable containers, in
a well ventilated independent compartment, depending upon the space availability on deck or
below deck. The storage room should be of fireproof and seamless construction with an acid
resistant floor. PERACLEAN OCEAN must not be confined in vessels, piping systems, or
between valves. There must always be pressure release, such as a rupture disc, or breathing
devices fitted to any volume that can be closed. For storage tanks a pressure release of at least
100 cm2 per metric tonne is required. The storage temperature should not exceed 35 0C. A
device should be provided for rapid overboard discharge of the storage tank in case of
emergency. The amount stored should be kept as low as reasonably practicable. Exposure to
any external source of heat is to be prevented. Connection to containers is identified as a
particular hazard to personnel and the use of personal protective equipment including a full
chemical protective suit and respiratory protection is required for this task and in accidental
situations.
The requirement for a storage temperature below 35 0C without the use of a temperature
controlled atmosphere will preclude the use of this product in some areas, particularly where
tropical conditions may be encountered. Positioning of storage space ventilation outlets will
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require careful consideration to avoid risk to personnel should any spillage or operation of the
pressure release device occur. As compatibility of materials is essential, then the overboard
emergency discharge arrangements will require particular consideration. It is worthy of note that
the IMDG Code requires transport of this type of commodity on deck only.
Only suitable stainless steel should be used for piping, hose lines, fittings, seals and pumps. All
transmission piping must be easily accessible and welded in one piece whenever possible.
It is envisaged that storage in the engine-room will not be possible due to both safety and
temperature reasons; therefore a long supply pipe to the dosing unit will be necessary. Even
though the submission states that due to the automated process in ballast water application and
dosing, personnel exposure is unlikely to occur during the treatment operations, leakages will
always be of concern and the routing of the supply pipe away from all sources of heat such as
engine exhaust arrangements and steam piping will require care, particularly as the product
decomposes at temperature greater than 60 0C Flushing arrangements for the supply piping and
dosing system will need to be considered to permit maintenance without the possibility of
spillage or leakage of the chemical to the engine room. It is recommended that extraction
ventilation is provided by way of the dosing unit to remove traces of a possible vinegar smell
(acetic acid); this may be problematic where the dosing unit is arranged in the engine-room as
positive pressure ventilation is an engine-room norm. It will be necessary to provide venting
arrangements for the supply piping or other breathing devices to outside the engine room to avoid
potentially dangerous contaminations. Personal protective equipment including respiratory
protection, hand protection, eye protection, acid proof clothing and rubber or plastic boots will
require to be supplied ready for use in locations where there is any possibility of spillage or
leakage.
As PERACLEAN OCEAN is a strong oxidizing agent and highly reactive; fire will always be a
concern. The potential for leakage to bilges contaminated with oils must be considered.
Automatic sprinkler systems should be located above the storage tank and dosing section, and
fire fighting instructions recommend the use of positive pressure breathing apparatus.
The recommended safety precautions such as the use of positive pressure breathing apparatus and
full chemical personal protection are not normally encountered on ships other than specialized
chemical carriers. In consideration of the risks that may be encountered in the use of this
product, it may be appropriate to require additional training in the use of dangerous chemicals for
crewmembers to that available from the supplier, such as that provided by the dangerous cargo
endorsement for chemicals.
The submission states that tests with diluted PERACLEAN OCEAN show no damage to standard
epoxy tank coatings. It is recommended that the corrosive effect is monitored for confirmation of
this statement. As the substance is highly reactive with zinc, further confirmation that use of this
product is permissible where the ships ballast system piping is internally galvanised is necessary.

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Environmental fate and exposure

Fate and behaviour properties

Property
Hydrolysis
pH4
pH7

PAA
DT50 = 48 h
DT50 = 48 h

pH9
Photolysis
Degradation in seawater

DT50 = 720 min

Ready biodegradation
Biodegradation
Sorption
Bioconcentration
Anaerobic degradation

> 70%
Rapid
Very low
No
-

H2O2
Variable but
short

DT50 = 3.6 h
DT20 = 25-35
min
n.p.
DT50 = 21h 5d
Very low
No
-

Acetic acid
> 70%
Very low (e.j.)
No
-

Fate in ballast water tanks

The prescribed optimum dosage of PERACLEAN is an initial concentration in the ballast water
at 150 mg PERACLEAN/L corresponding to initial concentrations of peracetic acid of 23 mg/L,
hydrogen peroxide of 21 mg/L and acetic acid of 38 mg/L.
After application in ballast water, a complete decay of peracetic acid was observed after 10-15
hours of exposure. Hydrogen peroxide degrades more slowly.
According to the available dossier, three different experiments have been conducted for
simulating degradation in ballast water.
In one experiment with application of 150 mg Peraclean/L to filtered clean seawater (low
concentration of POC/DOC), the concentrations of hydrogen peroxide were measured to 20 mg/L
after 5-10 hours and 15 mg/L after 50 hours of exposure corresponding to a degradation of
approximately 25%. In another experiment with dosing Kiel Harbour water with 17.2 mg/L resp.
30 mg/L, the H2O2 concentrations after 24 hours were 1.4 2.5 mg/L depending on the initial
concentrations (corresponding to approximately 92% degradation in 24 hours). The amount of
H2O2 at the end of the BW treatment seems to be proportional to the amount of organic matter in
the water.
Assuming a minimum holding time of 2 days according to use specifications, a maximum
content of hydrogen peroxide of 15 mg/L may be used as the basis for further evaluation of
environmental fate and effects.

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Fate in the environment

After discharge of ballast water to the aquatic environment, hydrogen peroxide will undergo
further degradation in the water phase. Based on the physicochemical properties of the substance,
no significant sorption to particulate or organic matter is expected and neither is volatilisation.
For the long-term assessment, the applicant uses the MAMPEC model to estimate PEC in port of
Rotterdam and also to assess the worst case without the effect of degradation of active substance
after discharge. There are no data documenting the discharged concentration of active substances
used in the model and the model is documented neither in the report nor in the dossiers. It is
therefore difficult to control the calculated PEC values used in the table below.
Discharged volumes are presented in document MEPC 53/2/12 (approximately 390,000 ton/day).
The total load of H2O2 used in the MAMPEC model is given to be 30 kg H2O2/day from the
ballast water. The concentration in the discharged ballast water can from this be calculated to be
0.077 mg H2O2/l.
Without more details about the input data to the model and a documentation of the model, it is
difficult for the Group to accept the presented PEC.
7

Environmental hazards

7.1
Short-term and long-term aquatic toxicity test data are available for peracetic acid (PAA),
hydrogen peroxide and the preparation PERACLEAN OCEAN with a range of marine and
freshwater species.
Peracetic acid (PAA)
The group considers that the following studies are the key studies for peracetic acid:

Fish acute toxicity, 96 h LC50 = 1.6 mg/L2 (rainbow trout)

Fish chronic toxicity, 7 d NOEC = 1.9 mg/L (survival of Menidia)
Crustaceans acute toxicity, 48 h EC50 = 0.5 mg/L (Daphnia)
Crustaceans chronic toxicity, 21 d NOEC = 0.05 mg/L (Daphnia reproduction)
Algae growth, 72 h NOEC = 0.074 mg/L
Bivalve acute toxicity, 48 h EC50 = 0.27 mg/L (blue mussel larvae)

The Group noted some errors in the summary dossier, e.g. Macomona lilliana is not a fish, but a
bivalve (shellfish) and the effect concentrations for Mytilus edulis are in mg/L and not in mg/mL.
Based on the available test data, a Predicted No-Effect-Concentration for long-term exposure can
be derived using an assessment factor of 10 to the lowest effect data resulting in PNEC = 0.007
mg PAA/L. However, the Group noted that PAA does not persist long in the environment.

The test data are difficult to interpret and the effect concentration may refer to a 5% PAA solution corresponding to
a LC50 = 0.08 mg PAA/L.
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PAA is degraded almost completely after less than 24 hours. The Group has therefore based its
consideration/assessment on the presence of a residual concentration of hydrogen peroxide
(H2O2) as the most relevant substance contributing to the toxicity.
Hydrogen peroxide (H2O2)
Considering the toxicity criteria for identification of PBT substances in Table 1 in the G9
Guidelines (Chronic NOEC < 0.01 mg/L) and the EC50/NOEC data for the most sensitive
organism presented in the submitted dossier (table below), it can be concluded that H2O2 and
thereby the PERACLEAN itself are not considered to be toxic.
H2O2 toxicity values for the most sensitive organism (Source: DEGUSSA AG March 15, 2005, risk
characterization In: Request for approval of PERACLEAN OCEAN for ballast water Treatment, Assessment
report)

Taxonomic
group
Fish
Crustaceans
Algae
Snail
Bivalve
-

Species

Endpoint

Mortality
Pimephales
promelas
Daphnia magna Immobilisation
Growth
Skeletonema
inhibition
costatum
Growth
Chlorella vulgaris
inhibition
Mortality
Physa sp.
Mortality
Dreissena
polymorpha
Mortality &
Mytilus
development
galloprovincialis

Result

Reference

LC50 (96h): 16.4 mg/L

EU 2003

EC50 (24h): 2.3 mg/L

EC50 (72h): 1.38 mg/L
NOEC (72h): 0.63 mg/L
EC50 (72h): 2.5 mg/L
NOEC (72h): 0.1 mg/L
EC50 (96h): 17.7 mg/L
LC30 (56d): 5 mg/L
NOEC: 2 mg/L
EC50 (48h): 1.58 mg/L
NOEC (48h): 1.25 mg/L

EU 2003
EU 2003
EU 2003
EU 2003
EU 2003
Dossier

In the EU risk assessment report, a PNEC of 10 g/L was derived. The applicant, however,
considers this value to be very conservative due to a number of reasons.
8

Environmental risks

PBT assessment
The following properties of the components of PERACLEAN OCEAN are found:
Peracetic acid
Hydrogen peroxide
Acetic acid

Persistence
Very quickly
degradable
Readily biodegradable

Bioaccumulation
Log Pow = -0.52

Toxicity
NOEC = 0.07 mg/L

Log Pow = -1.5

NOEC = 0.1 mg/L

None of the components of PERACLEAN OCEAN fulfils any of the three PBT criteria and
consequently, none of the components are assessed to be PBT substances.
Toxicity of treated ballast water
Short-term aquatic toxicity test with ballast water sampled immediately after treatment and 48
hours after treatment have been conducted with bivalve larvae (Mytilus galloprovincialis). In
addition, as the treatment resulted in a change of the pH in the ballast water, a test was conducted
with a pH-adjusted sample.
The following results of the toxicity tests were obtained:
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Freshly treated sample, EC50 = 2.4%

Treated sample (48 hours storage), EC50 = 18.6%
Treated sample (48 hours storage, pH adjusted), EC50 = 17.6%

Thus, the toxicity of the ballast water decreased by 86% during 48 hours of treatment. Assuming
a concentration of 15 mg/L of hydrogen peroxide after 48 hours treatment, the EC50 determined
corresponds to a concentration of hydrogen peroxide at 2.5 mg/L. This corresponds to the EC50
determined in the same test with hydrogen peroxide at 1.6 mg/L.
Environmental risk assessment
The test system used for testing the toxicity of treated ballast water was chosen by the applicant
as it was among the most sensitive of species tested with hydrogen peroxide. Short-term toxicity
to other species incl. algae seems to be at the same level. Taking the toxicity of the treated ballast
water as well as the toxicity of hydrogen peroxide to aquatic species into account the Group
considered that some acute impact may be expected in the surrounding area of the discharge
depending on the amount of organic matter and suspended solids in the ballast water to be treated
and the dilution processes occurring in the receiving environment.
The environmental risk of the estimated and measured concentrations of hydrogen peroxide in
treated ballast water has been assessed as well. The application report concludes that the
calculated PEC of H2O2 is lower than PNEC as presented in the table below.
The Group calculated also PEC/PNEC ratio considering the toxicity data for the most sensitive
organism (see table below) and other information from the dossier. The H2O2 PNEC in water
proposed by the EU (in EU, 2003, Hydrogen Peroxide, Summary Risk Assessment Report) is 10
g/L. In the calculations the Group used both conservative and non-conservative PEC values as
provided in document MEPC 53/2/12 included in the dossier. The PEC/PNEC ratios are
presented in the table below.
PEC/PNEC for H2O2 discharged

Source
MEPC 53/2/12
(worst case scenario
with H2O2
degradation)
MEPC 53/2/12
(worst case scenario
without H2O2
degradation)

PEC
(g/l)

NOEC
(g/l)

Assessment PNEC(g/l)
factor

PEC/PNEC

4.9

100

10

10

0.49

9.9

100

10

10

0.99

If we accept the PEC values calculated with the MAMPEC model, the Group can conclude that
for the long term the risk of discharge will be acceptable even for the high concentration at
discharge. However, as mentioned above, the use of the MAMPEC model as well as the scenario
and input parameters have not be sufficiently justified in the dossier.

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Conclusions and recommendations

Upon application of PERACLEAN OCEAN in ballast water, the PAA is degraded almost
completely after less than 24 hours. Hydrogen peroxide, however, degrades more slowly with the
degradation rate depending on the content of organic matter and particles in the ballast water.
Applying the recommended dosing of 150 mg/L PERACLEAN OCEAN, a typical concentration
of hydrogen peroxide at 2 mg/L may be expected in the discharged ballast water. In cases where
ballast water has a low content of organic matter and particles, and where the holding time is
short (48 hours or less), concentrations of up to 15 mg/L of hydrogen peroxide may be expected.
Aquatic toxicity testing with treated ballast water shows that the acute toxicity encountered can
be ascribed mainly to the content of hydrogen peroxide. It is further noted that even with the
lowest concentration of hydrogen peroxide in the treated ballast water (2 mg/L), a dilution of the
discharged ballast water of at least 200 times is required to reach environmental concentrations
below the Predicted No-Effect-Concentration at 10 g/L according to the EU Risk Assessment
Report available.
Exposure modelling has been performed using the MAMPEC model. The assumptions on the
scenarios as well as input parameters of the model are not presented in detail, which hinders the
evaluation of the reliability of the model results. It appears from the dossier that resulting
concentrations in the aquatic environment after discharge and dilution are at the maximum of 510 g/L of hydrogen peroxide which is lower than or equal to the PNEC value established. Thus,
the application and discharge of PERACLEAN OCEAN seem to cause no unacceptable harm to
the environment.
Based on the above evaluation and conclusions, the Group recommends that a basic approval of
the use of PERACLEAN OCEAN as a ballast water biocide should be given. However, the fullscale testing as well as an eventual application for a final approval should consider a number of
issues:

A number of concerns in relation to safety of ships have been raised in section 5 due to
the physico-chemical hazards of PERACLEAN OCEAN. These concerns need to be
addressed prior to initiation of full-scale testing onboard ships.
Based on the submitted scientific information about the toxicological profile of PAA 15%
preparation, we can anticipate major concerns towards acute adverse effects
(corrosiveness, severe irritant for skin and eye, irritant for the respiratory tract). In this
sense, we recommend as mandatory the application of RMM (risk management measures)
for the protection of the exposed populations to the main routes of concern: dermal and
inhalation. These control measures (PPE and RPE) must be put in place for use and
handling of the preparation at the different stages of the process and with the different
concentrations applied.
Additionally, it is recommended that dermal and inhalation sub-chronic effects in
presented studies should be further investigated, taking into account realistic occupational
exposure scenarios and covering non-accident situations. These data should be submitted
before final approval.
There seems to be insufficient information on degradation of components of
PERACLEAN OCEAN during treatment of ballast water as it seems to depend on the
content of organics and particles in ballast water. This should be further studied and

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reliable estimates or measurements of concentrations of the components at discharge

should form the basis for the environmental risk assessment.
The selection of appropriate scenarios for discharge of treated ballast water needs
consideration and justification. This would include proposals for numbers of ships in the
harbour, the volume of treated ballast water, the frequency and duration of discharges, the
dimensions of the harbour including water volume and flow. The Group notes that this is
not necessarily an obligation of the individual applicant, but that this might be considered
at a general level (cf. the report of the BWWG 1 meeting).
Based on the updated information, a revised environmental risk assessment needs to be
submitted for a final approval.

However, after a careful evaluation of the available information, the Group recommends that
a basic approval is issued allowing a full-scale development and testing.

***

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ANNEX 6
REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES
- SUBMITTED BY REPUBLIC OF KOREA
(ELECTROCLEAN)
ELECTRO CLEAN evaluation report
The basis for the Working Groups evaluation of ELECTRO CLEAN system (ECS) was the
application dossier submitted by the Republic of Korea. Further data sources were found in the
IUCLID data base hosted by the European Commissions European Chemicals Bureau.
1

Completeness of the dossier

The application dossier is not considered to be complete as the following information is missing:

Effects of the maximum total residual chlorine (TRC) concentration (20-30 mg/l) and also
a quantitative risk assessment to the environment.
Information on the reliability and accuracy of the control scheme.
The dossiers do not provide any data on the corrosivity of the treated ballast water.
Data on human exposure to the active substances not allowing risk evaluation of use and
handling
Justification of non submission of data
Calculation of the predicted environmental concentration (PEC) in the dossier and in
document MEPC 54/2/3 are based on the MAMPEC modelling from the German
application. The Group had several comments to the MAMPEC model results and further
pointed out that to use these without access to the input data does not produce any
valuable data. The calculated PEC values are therefore only used as indicative estimates
in this assessment.
Identity

Physicochemical properties
Property
Molecular weight
Physical state
Melting point [C]
Boiling point [C]
(Relative) density [kg/m3]
Vapour pressure [Pa]
Solubility [g/L]
Log Kow
pKa
Viscosity [cP]
Henrys law constant [-]
Flash point [C]
Auto ignition temperature
[C]
Flammability
Explosive properties
NA = not applicable
I:\MEPC\54\2-12.doc

Cl2

HOCl

HO

70.906
Gas
-101
-35
3.214 [g/m3]
6.8 105
14.6

17
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA

52
liquid
-6
40 (d)
1.1
NA
Miscible
-3.42
0.01327

NA
NA
(d) = decomposition at indicated temperature

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3
Application
The submission informs of Electro-Clean technology which disinfects ballast water by
electrolysis. Disinfection is carried out directly from the electrical potential and from the
generation of free chlorine, sodium hypochlorite and hydroxyl radicals, and by electrochemical
oxidation through the creation of ozone and hydrogen peroxide. No chemicals are required to be
stored on board as the active substances are produced electrically in-situ from the uptake of
ballast water within the electrolysis module by fully automatic operation using a remote
monitoring/control system. A pre-filter is used to remove larger solids.
In this system, the generated initial concentrations of active substances are controlled by applied
current density to the flow cell of the electrolysis cell. And the volume directly influences the
TRC concentration at discharge and environmental risks. In the background documents, planned
to set the sensor at the exit point of the system before ballast tank and monitors the value,
which is used for the control parameter of the systems. But there is no description about the
sensor; directly measuring TRC, or some indirect sensor for ORP, etc.
It is not clear to the Group whether or not the ELECTRO CLEAN system (ECS) is able to
function if freshwater is used as ballast water.
4

Human health hazards

The active substances Cl2, HOCl, OCl, and OH radicals are produced electrolytically in situ and
presumably have a very short-life.
The biocidal efficacy of the formulation is considered to be a result of its equilibrium formulation
which in fact is regulated by the equipment itself. It is considered to be a preparation whose
efficacy to be attained must be permanently monitored. Toxicological data presented by the
applicant are disperse and relating to different concentrations of the different compounds
involved in the disinfection process whose composition in the equilibrium solution includes free
chlorine, sodium hypochlorite and hydroxyl radicals.
Table Qualitative health effects assessment relating to the compounds existing in the equilibrium
solution (Hypochlorite, Chlorine, Hydroxyl radicals)
Main compounds in the equilibrium solution
Chlorine
health Hypochlorite

Human
endpoints
Acute toxic effects
Oral

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Irritation, pain,
inflammation of mucoses.
In severe cases causes
ulceration and perforation
of gastro intestinal tract.
Health effects depend on
several factors: amount,
concentration and pH of
the solution

Irritant effects

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 shortterm mechanism is the

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endpoints

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Main compounds in the equilibrium solution

Chlorine
health Hypochlorite

Hydroxyl radicals
respiration
compensation. A longterm mechanism is the
renal compensation.

Dermal
Inhalation

Mild irritation to corrosive

injury 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

Effects on skin
and eye
Skin irritation
Can cause mild irritation to
corrosive injury depending
on the duration of contact,
concentration and pH of
the solution
Skin sensitization
Negative results have been
obtained for 8% sodium
hypochlorite solution;
insufficient information
available to characterize
this endpoint
Eye irritation
Mild irritation to corrosive
injury depending on the
concentration and pH of
the solution and on the
duration of contact, as
well. If warmed at higher
temperature can release
significant amounts of gas
which is a severe eye
irritant
Hypochlorite does not easily
Irritation to the
form vapours however in
respiratory tract
more concentrated solutions
and at high pH, mists that
I:\MEPC\54\2-12.doc

Irritant effects
This is the major route
of concern, chlorine
gas vapours are heavy
and settle down in low
areas
Irritant effects; acute
inflammatory effects
towards the
respiratory tract

Acute inflammatory
effects

Acute inflammation
effects towards cornea
and conjunctiva

Acute effects

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Human
endpoints

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Main compounds in the equilibrium solution

Chlorine
health Hypochlorite

form can cause mild to

severe irritation of the nose
and throat
Repeated
Dose Not available
Toxicity (90 d)
It
was
shown
that
Toxicokinetics
hypochlorite
does
not
accumulate in the body, it
reacts with tissues and
apparently
is
readily
absorbed in serum and
eliminated from plasma with
half-life of 44 h.
Chronic and long From the applicants report it
term
toxicity was not possible to conclude
if the substance is an
health effects
occupational skin sensitizer;
however some sporadic
cases are reported.

Has not been suggested as

mutagenic according to
available information.
However, some effects
concerning sperm shape
have been recorded
No specific conclusions
Developmental
and reproductive about the potential for
developmental toxicity in a
toxicity
chlorinated drinking water
study.
There is insufficient
information to draw
conclusions. However, some
indicative effects of altered
sperm shape have been
detected
It is not classified by IARC.
Carcinogenicity
In most studies there is a
lack of statistical evaluation
of the results and lack of
dose-response relationship

Not available

May cause dyspnea,

palpitations, chest pain
reactive, upper airways
dysfunction syndrome
Chronic exposure to
chlorine gas is one of
the most frequent
causes of occupational
asthma

Mutagenicity/Gen
otoxicity

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

Chlorine was
considered teratogenic
in experimental
animals

Lymphoma has been

observed in relation to
water treatment with
chlorine. Associations
with increased renal,
bladder and gastric
cancers have been
registered

Hydroxyl radicals

Not available

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From the above information it is concluded that the main health effects are acute in nature;
however some concerns are addressed related to the reproductive system under long term
exposure scenarios.
5
Risks to safety of ship and crew
The submission states that the application of Electro-Clean technology is safe to the ship and
crew during operation as the level of active substances produced is below recognised standards
for dangerous substances, and that the active substances generated remain within the closed
ballast water system.
The dossier presented refers to tests with simulated ballast water indicating that Trihalomethane
(THM) discharges remain within acceptable limits. The residual chlorine levels immediately
following treatment are given as being in the range of 1030 parts per million. Other studies
have suggested that THM is formed from the breakdown of chlorine and organic matter and that
THM generation increases with pH, time, temperature and the amount of organic matter present.
A level of 10 ppm chlorine has been suggested as providing the highest production of THM and
that levels above 1 ppm/THM can produce unacceptable levels.
It is indicated that there may be a need to ventilate hydrogen generated during the electrolytic
generation in order to prevent accumulation.
It is also stated that free chlorine gas was generated during the process.
As both hydrogen and chlorine gas are explosive, and as THM is a carcinogenic, it should be
confirmed that residual levels of these substances within the ballast tanks following the treatment
process remain within acceptable limits for crew and ship safety. Monitoring of levels of these
substances and additional appropriate safety procedures should be required for the opening of
treated ballast tanks and personnel tank entry until it has been verified that such precautions are
unnecessary.
The submission informs that tests with chlorine solutions have previously resulted in an
increased degradation effect on tank coatings together with increased corrosion. This may be
especially relevant for ballast piping after the treatment unit as additional turbidity caused by gas
generation may be anticipated.
No data of the corrosivity of treated ballast water was provided in the dossier. However, other
reports available for the Group indicate an increase of approximately 100% of normal corrosion
rates in the lower sections of ballast tanks. The initial concentration of TRC in these studies were
reported to be around 5 mg TRC/L, while the initial studies in the ECS is given to be between 20
and 30 mg TRC/L. The applicant therefore should provide corrosion studies going over at least
six months.

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Environmental fate and exposure

6.1

Fate and behaviour properties

Property
Hydrolysis
pH4
pH7
pH9
Photolysis
Degradation in seawater
Ready biodegradation
Biodegradation
Sorption
Bioconcentration
Anaerobic degradation

Cl2
Dissociation
Dissociation
Dissociation
Very quick
Dissociation
NA
NA
NA
NA
NA

HOCl

HO
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA

Unstable
Unstable
Unstable
Very quick
Unstable
NA
NA
NA
NA
NA

NA = not applicable
6.2

Fate in ballast water tanks

Considerations:
As stated in the application dossier the formation of the Active Substance is described
with the following reaction equations:
HCl + HOCl
Cl2 + H2O
HOCl
H+ + OCl
where HOCl and OCl are considered the real actives.

The amount of chloride ions present in seawater is about 19.5 g Cl/L.

In seawater also bromine is a natural constituent amounting about 0.068 mg Br/L.
At normal pH-values in seawater OCl will react with bromine to HOBr which is even
more reactive than HOCl.
Both substances may oxidise organic compounds present in seawater which
subsequently are degraded to finally H2O and CO2.
In the literature it is known that amongst these oxidation products also
trihalomethanes, halophenols, and chlorinated acetic acids are formed.
Another concern was the release of metals from the oxidised material.

Research into the above areas showed generally no increase to higher levels than the detection
limits of the chemicals of concern. Concentrations determined stayed generally well below the
limit of detection.
Some experiments determined the half life of total residual chlorine (TRC). TRC is defined as the
amount of chlorine still active. It was found that there is a significant difference in the TRC
levels after exposure in light or dark conditions. Generally, under light conditions the TRC-levels
decreased to low levels (>90% decrease) but under dark conditions a much lower decrease was
found especially within the first couple of days. After this time often a quick decrease followed,
but levels stayed at much higher levels than under light conditions. Levels up to 30% of initial
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concentration and in one case up to about 60% of the initial level was still present. In such cases
dechlorination with e.g. sodium bisulfite was recommended.
Therefore, TRC levels up to 20 mg/L may be expected in certain circumstances based on
normally generated rates of HOCl (30 mg/L). Such levels exceed to a great extent the USEPAstandard of 0.013 mg/L for effluents.
6.3
Fate in the environment
After discharge of the ballast water the amount of TRC will be reduced very quickly because of
the changed light conditions; although the turbidity of the receiving waters will limit the decay.
6.4
PEC calculation
The document MEPC 54/2/3 in item 5.4 presents information about the effect of TRC discharged
to sea water. PEC is presented for a scenario simulating discharge of ballast water treated by the
system at the Rotterdam harbour. It was considered that the total residual chlorine (TRC) at
discharge, proposed in Doc. MEPC54/2/3, was too high because this number was estimated to be
the concentration at the exit of the system. We can expect that some degradation of TRC in
ballast tanks along the time. The Group also calculated a PEC for a TRC concentration of 5 mg/l
in the discharged water for a more realistc scenario using the same dilution ratio (about 2140 ).
7

Environmental hazards

7.1
Active substance and preparation
The active substances from the Electro-Clean treatment system are stated to be:

Cl2 (Chlorine)
HOCl (Hydrogen hypochlorite)
OCl (hypochlorite ion)
OH (hydroxyl free radicals)

Remarks:
High concentrations (20 30 mg/L) of the above mentioned active substances will
quickly react with other substances in the seawater and the active substances will be an
equilibrium mixture of hypochlorous acid (HOCl), hypochlorite ions (OCl),
hypobromous acid (HOBr), hypobromite ions (OBr) and others. These are often referred
to as chlorine produced oxidants (CPO) in seawater or total residual oxidants (TRO) in
freshwater and refer to the sum of all oxidant compounds produced. Data for bromide
compounds are not presented or discussed in the dossiers. By the presence of bromide in
sea water during the electrolytic process, bromine and consequently hypobromous acid
and hypobromite will be also produced and no consideration was given about these
actives substances in this assessment.
There is little information about the active substances formed when electrolysing
freshwater.
7.2

Aquatic toxicity data

Remarks:
1. In the dossiers some data have been indicated as chronic. According to the Group
these should be considered as acute toxicity data.

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2.

The test data claimed to present acute toxicity with 30 and 60 minutes exposure.
They should be considered as not relevant for assessing environmental hazards and
they are therefore not used in this assessment.
3. Short term and long-term aquatic toxicity test data are available for all these
compounds in open literature data-sets with a range of marine and freshwater species.
To some extent the Group has compiled such data for this assessment.
Chlorine
Aquatic toxicity data of chlorine with some species are presented in the table below:
Taxonomic group Species
Endpoint
Result
Reference
Invertebrate
Mortality
4 h TL50: 0.019
Keratella
mg/l
cochearis
Fresh Water Fish Salmo gardnerii Mortality
168 h LC50 =
0.08 mg/l
Hypochlorite ion/Hydrogen hypochlorite
Aquatic toxicity data of hypochlorite with key species are presented in the table below:
Taxonomic
Species
Endpoint
Result
Reference
group
Algae
Growth
EC50
(24h): IUCLID
Thalassiosira
inhibition
0.075 mg/L
guilardii
Crustaceans
LC50
(24h): IUCLID
Ceriodaphnia sp. Mortality
0.006 mg/L
Fish
LC50
(96h): IUCLID
Clupea harengus Mortality
0.033-0.097
mg/L
Mortality
LC50
(96h): IUCLID
Oncorhyncus
0.023-0.052
gorbuscha
mg/L

Estimated NOEC from acute results from Daphnia neonate individuals = 0.031 mg/l
NOEC for Mysid (opossum shrimp) = 0.087 mg/l

Free hydroxyl radicals

This compound is extremely short lived in the ballast tanks and will probably not be discharged
to the environment. Acute toxicity data are therefore not presented.
7.3

Conclusion and recommendation

Should be pointed out that due to the presence of bromide in the sea during the electrolitic
process bromine and consequently hypobromous acid and hypobromite will also be produced and
no consideration about these active substances is contained in this assessment.

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Environmental risks

8.1
PBT assessment
The following properties of the components of ELECTRO CLEAN are found:
Compound
Persistence
Bioaccumulation
Toxicity
Chlorine
Hypochlorite
NOEC: 31 g/L
Free hydroxyl radical
Very quickly
degradable
None of the substances identified in the application dossier as being generated in the
electrolytical process fulfil the criteria for PBT substances. Other substances that might be
generated during and after the process may possess PBT properties, but it has not been possible
to consider this in the current evaluation due to lack of information.
8.2
Toxicity of treated water when discharged
Remarks:
Some of the data provided in the three dossiers regarding possible concentrations of
active substances in the discharged treated ballast water seem to be contradictory to the
conclusions in the application (MEPC 54/2/3). This is in particular the case for the decay
rates presented for TRC where several studies indicate that TRC may be higher than 8
mg/L after 1 2 days (or more), while the application states (MEPC 54/2/3 p. 21) that the
TRC in the discharge will be less than a few mg/L and on p.24 section 7.2.5 the halflife
under dark condition is 2 days. According to the BMT study provided in the dossier
(Book 3) the resulting biological efficacy of 8-9 mg TRC/L is high (approx. 96%). From
this it may be concluded that the acute toxicity may be high when treated ballast water is
discharged.
In the dossiers and MEPC 54/2/3 there are several references to permitted effluent limits
of TRC. According to USEPA 1999 the CMC (Criteria Maximum Concentration) is 13
g/L of chlorine (as free chlorine). This value is also used as limit for CPO in effluent
water to enclosed bays and estuaries in the 2005 Draft from California Environmental
Protection Agency (1 hour average concentration), the 4 day maximum average
concentration is given to be 7.5 g/L.
Dilution calculations are copied from the German application and contain even less
background information about the basic assumptions on the scenario and the input data
for the calculations than the original. These dilution calculations are therefore of little
value for this assessment.
Data from several studies presented in the dossiers are not used in the application
(MEPC 54/2/3)
The retention time of treated water before testing the aquatic toxicity of the dilution series
is not given, but the Group assumes this to be immediately after treatment.
The aquatic toxicity of treated ballast water is tested in a dilution series presented in pages 80-81
in Technical Add Documents (Book 3). There was no information about the concentration of
TRC in the tested water. Dilutions of the treated ballast water vary between 1:1 and 1:250.
Results may be calculated as an indication of LC50 for the treated ballast water, which results in
the following approximate values of LC50:
- Algae: < 0.4 2%
- Ciliates: 5 10 %
- Copepods (Acartia): 40 %
- Fish: 10 20%
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Based on these estimates, the Group concludes that a dilution of around 100 times is necessary
for avoiding acute toxic effects of the treated ballast water.
Therefore, considering the degradation of the TRC presented in the dossiers and the toxicity
values above, acute impacts to the aquatic biota may be expected in the surrounding area of the
discharge.
8.3
PEC/PNEC
The reported NOEC for calculation of the PEC/PNEC ratio was considered. The NOEC from
chronic toxicity results available for hypochlorite for daphnia provided from the dossier was used
and it was also assumed that the TRC was referred to hypochlorite. The PEC/PNEC for the TRC
of 5 mg/l was calculated for daphnia. [I dont understand this sentence? In my view, it could go
out.] The lowest acute toxicity data available for other organisms was used. The table below
presents the values of PEC/PNEC.
PEC/PNEC for NaOCl discharged

Source

PEC
(g/l)

NOEC
(g/l)

Dossier & Doc.

MEPC 54/2/3

14

31

Dossier & Doc.

MEPC 54/2/3

14

87

Calculated

2.33

31

Calculated

2.33

Assessment PNEC(g/l)
factor
10
3.1
100
0.31

PEC/PNEC
4.52
45.2

10
100

8.7
0.87

1.61
16.1

10
100
10
100

3.1
0.31
0.6
0.06

0.75
7.52
3.8
38

In general, the PEC/PNEC is higher than 1 for the majority of the cases. The results suggest that
there is a possibility of long term effects in a receiving environment by the continuous discharge
of the water treated by the system.
9

Conclusions and recommendations

9.1
The active substances produced by the system appear to produce short term impacts and
potential long term impacts to the receiving environment.
9.2. The Group considered that human exposure to the active substances generated by ECS is
most probably associated to acute health effects (irritation to skin and respiratory tract) therefore
recommended as mandatory the application RMM (risk management measures) for the protection
of the exposed populations to the main routes of concern: dermal and inhalation. In addition, and
taking into account the actual scientific knowledge, the adverse health effects associated to
chlorinated by-products exposure should be further investigated, mostly on the long term
scenarios.
9.3
Mitigation procedures or operations should be established to reduce the TRC to levels
that avoid risk to the environment in the case of short trips and during the treatment of fresh
waters.
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9.4
It seems that the application of the ECS leads to creation of substantial amounts of very
reactive species, in particular chlorine solutions that may lead to increased corrosion of the tank
and piping. The potential damage to the ship has not been elucidated.

The amounts of total residual chlorine (TRC) formed during the electrolytic process
result in concentrations in the treated ballast water that largely exceed limit values
established for discharge of waste water from land-based point sources. The
degradation rate of TRC is so low that substantial concentrations may be expected
also at discharge of treated ballast water. In addition, the potential health risks have
not been sufficiently characterised.
Acute aquatic toxicity tests have been conducted with sea water to different species
immediately after treatment with ECS. The tests showed that a dilution of up to more
than 100 times is required before acute toxicity can be avoided.
The assessment of environmental exposure concentrations have apparently been based
directly on the same model calculations with the MAMPEC model as presented in the
application dossier submitted by a separate applicant. The Group would require access
to the input data and more information on the parameters within the model in order to
ascertain the vailidity of the results.
Finally, an aquatic risk assessment based on the measured concentrations in treated
ballast water, the dilution model assuming a dilution of approximately 2,000 times
and derived Predicted No-Effect-Concentrations for hypochlorite showed an
estimated risk to the aquatic environment.
The dossier does not include documentation of which actives are produced in fresh
water application. A full documentation of their properties should be included.
The application dossier does not include documentation of the quality control/quality
assurance programme as requested in G9: 4.2.4.

9.5
After considering all of the above concerns, it is the opinion of the Group that the
proposal has not demonstrated whether there is a potential for unreasonable risk for environment,
human health, property and resources. The Group therefore considers it appropriate that further
land-based studies be conducted before on board testing eventually takes place. Consequently,
the Group recommends that the Organization should grant a basic approval to the proposed
Electro Clean System with conditions that land-based testing address the concerns for short- and
long-term impacts to the receiving waters before an eventual on-board testing is approved.

***

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MEPC 54/2/12
ANNEX 2
TIME SCHEDULE FOR REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST
WATER MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES
BY THE GESAMP-BWWG
Deadline

Action by submitting Member

28 weeks

provide the Letter of

Agreement
transfer the necessary
fees
submit the
comprehensive
proposals for approval
(dossiers)
submit the
non-confidential
document to MEPC

Time
allocation
8 weeks

20 weeks

n/a

1 week

19 weeks

n/a

1 week

18 weeks

14 weeks

Confirm their
acceptance for the
distribution of the report
after checking that no
confidential data is
contained
n/a

4 weeks

Activities to be undertaken by
the Secretariat
recruitment of consultant
contracting and travel
arrangements for the
members of the Group
verification of the
dossiers
correspondence with the
submitting members for
completion of dossiers if
required
consolidation of the
additional relevant
information received from
interested parties
facilitate the meeting of
the GESAMP-BWWG
assist consultant to
finalise the report and
circulate the final draft to
GESAMP
coordinate GESAMP
review and approval of
the report

1 week

13 weeks

n/a

13 weeks

week of
MEPC

n/a

1 week

consolidate the final

report and prepare the
submission to MEPC
Documents Section
processes, translates and
distributes the report as an
MEPC document
Committee takes into
account the report of the
GESAMP-BWWG when
deciding on Basic
Approval

_____________

Members are kindly request to submit the non-confidential data to the session of the MEPC before the one
expected to decide or at their earliest opportunity after, but not after 28 week deadline indicated in the above.
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