I:\MEPC\54\2-12.doc For reasons of economy, this document is pr inted in a limited number. Delegates are kindly asked to bring their copies to mee tings and not to request additional copies. INTERNATIONAL MARITIME ORGANIZATION

IMO 

# E

MARINE ENVIRONMENT PROTECTION COMMITTEE 54th session Agenda item 2 MEPC 54/2/12 28 February 2006 Original: ENGLISH

HARMFUL AQUATIC ORGANI SMS IN BALLAST WATER

Report of the first meet ing 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 Wo rking 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 explor e 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 Wa ter 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 wa s 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 th e 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 eval uation, production and submission of the report in accordance with the Committeesí Guidelines for submission of documents, with an additional 8 weeks for the preparation of the meeting. Members are, therefore, kindly re quested to submit the non-confidential description of their methodologi es to the session of MEPC before the one expected to be decided on Basic Approval, or at the earliest oppor tunity after, but not after the 28 week deadline before the Basic Approval sess ion of the Committee (see table in annex 2).MEPC 54/2/12 - 2 -

I:\MEPC\54\2-12.doc 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 proposal s and to consider the timeline contained in paragraph 3 for future submissions.

***MEPC 54/2/12

I:\MEPC\54\2-12.doc 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 WATE R WORKING GROUP

Table of Contents

Section Paragraph Nos. Page Nos.

1 INTRODUCTION ÖÖ..ÖÖÖÖÖ............................. 1.1 ñ 1.4 3

2 ISSUES OF CONFIDENTIALITY Ö..ÖÖÖÖÖÖ... 2.1 ñ 2.3 3 - 4

3 TERMS OF REFERENCE ÖÖ..ÖÖÖÖÖÖÖÖÖ 3.1 ñ 3.4 4 - 5

4 DEVELOPMENT OF A DRAFT METHODOLOGY FOR INFORMATION GATHERING AND THE CONDUCT OF WORK OF GESAMP-BWWGÖ.. 4.1 ñ 4-16 5 ñ 7

5 REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES ñ SUBMITTED BY GERMANY AND THE REPUBLIC OF KOREA ÖÖ. 5.1 ñ 5.10 7 - 10

6 MATTERS ARISING FROM RECENT IMO ACTIVITIES ÖÖ..ÖÖÖÖÖÖÖÖÖÖÖÖÖÖ 6 10

7 CONSIDERATION OF QUERIES FROM MEMBERS AND INDUSTRY ÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖ 7.1 ñ 7.2 10 - 11

8 FUTURE WORK PROGRAMME AND TENTATIVE DATE FOR THE NEXT MEETING ÖÖÖ..ÖÖÖÖ 8.1 ñ 8.4 11 - 12

9 CONSIDERATION AND ADOPTION OF THE REPORT ÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖ.. 9.1 ñ 9.4 12MEPC 54/2/12 ANNEX 1 Page 2

GESAMP-BWWG 1/9 - 2 -

I:\MEPC\54\2-12.doc 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 FOR THE GESAMP-BALLAST WATER 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 ñ SUBMITTED BY GERMANY (PERACLEAN OCEAN)

ANNEX 6 REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES ñ SUBMITTED BY REPUBLIC OF KOREA (ELECTROCLEAN)MEPC 54/2/12 ANNEX 1 Page 3

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I:\MEPC\54\2-12.doc 1 INTRODUCTION

GESAMP Ballast Water Working Group (GESAM P-BWWG) was held at IMO Headquarters, London, from 23 to 27 January 2006, under the chairm anship of Mr. Finn Pedersen. A list of members attending this first mee ting is shown in annex 1, and the agenda, as approved by the Group, is set out in annex 2.

1.2 Mr. RenÈ Coenen, IMO Technical Secretary of GESAMP, drew attent ion to the history, developments and merits of GESAMP as the a dvisory scientific and multi-disciplinary body within the United Nations system. Mr. Dandu P ughiuc, Head of the IMOís Office for Ballast Water Management, and the Secretary for th is 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 proce dure consists of two steps:

• Basic approval: An Administration of a Me mber of the Organi zation may propose an approval of a Ballast Water Management Syst em based on a satisfactory submission of a manufacturer developed in accordance with the (G 9) and the further details of criteria as being developed by the GESAMP-BWWG. In pr inciple, 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 syst ems 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 me thodologies and information requirements for conducting its work and to review the propo sals submitted by Governments of IMO Members for the approval of Active Substa nces in accordance with the Te rms of Reference developed by the Committee and accepted by the GESAMP Inter-Secretariat.

1.4 The Group considered its terms of referen ce 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 A pproval regarding the use of Active Substances had been submitted by two members of the Organization, na mely, Germany and the Republic of Korea.MEPC 54/2/12 ANNEX 1 Page 4

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I:\MEPC\54\2-12.doc The Secretariat informed the Gr oup that part of the information packages submitted by Maritime Administrations of IMO Members was ìnon-confid entialî and was consider ed 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 in terests of the producing companies. The Group suggested th at, after completion of the appr oval procedure, the following data and information should no long er be regarded as confidential:

• The name and address of the applicant

• The names and addresses of the manufactur ers 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 c ontribute to the hazard documentation of the preparation

• Physical and chemical data concerning the Active Substance and preparation

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

• Recommended methods and precau tions 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 give n in the case of injury to persons.

2.2 In evaluating an application, the Group reserv es its right to base its evaluation on any available information and to use this info rmation for justifying its conclusions and recommendations in its evaluati on reports irrespective of confidentiality i ssues. 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 th e evaluation report contains confidential information, the Organization should decide on the future procedures.

2.3 In case there were requests to IMO for mo re information regardi ng an application, the Organization would provide the name and addre ss 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 Te rms of Reference as annexed to this report.MEPC 54/2/12 ANNEX 1 Page 5

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I:\MEPC\54\2-12.doc 3.2 When considering its Terms of Referen ce, 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 fr om the authorizing administrations.

3.3 Consequently, the Group considered it overly optimistic to expect th at 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 av ailable, as well as thorough evaluations of proposals for approval of two applications regarding Active Substances.

3.4 The Group also suggested that MEPC may wi sh 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 ev aluation procedures and the leve ls 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 M ETHODOLOGY FOR INFORMATION GATHERING AND THE CONDUCT OF WORK OF GESAMP-BWWG

4.1 The Group noted that the MEPC ìProcedure for approval of ballast water management systems that make use of active substances (G9)î would form the basis for its work. In addition, the submission of the European Commission ME PC 54/2/1 to MEPC 54 was seen as useful guidance in defining the approaches for ev aluation of proposals for approval of Active Substances.

4.2 Prior to the meeting, the Secretariat had develo ped and circulated a first draft of a ìDraft Methodology for Information Gathering in Accord ance with the Procedure for Ballast Water Management Systems that make use of Active Substances (G9)î, 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 substa nces 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 tr eated ballast water a nd concluded that this would have to be considered on a case-by-case basis. In general, wh en 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 so rb 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 th e use results in very frequent releases to the same environment from different ships and wher e organisms in the environment therefore may be frequently exposed to treate d ballast water, an assessment based on long-term testing of the preparation and/or the treated ba llast water may be appropriate. In cases where only infrequentMEPC 54/2/12 ANNEX 1 Page 6

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I:\MEPC\54\2-12.doc releases take place, an assessmen t based on the long-term testing of the individual substances in the preparation would be more useful.

4.6 The Group discussed various approaches fo r structuring the dr aft methodology. Although a structure reflecting the sequentia l order of assessment of the haza rds and risks to the ship, the crew and the aquatic environment might have b een preferred, the Group considered that the structure of Procedure (G9) should be followed. Th is was further emphasized by the fact that the Group was informed that several applications we re under development in various Member States (cf. agenda item 8).

4.7 It is the intention that the draft methodology should serv e two purposes. On the one hand, it should be guidance to applicants on what to c onsider in their development of a dossier for the Ballast Water Management system using Active Subs tances. On the other hand, it should also be guidance to the Group in its eval uation and review of applica tions. The Group further noticed that, for the moment, the guidance is mainly in tended to relate to dossiers submitted for basic approval. Furthermore, the Gr oup considered that a submission for final approva l could probably not be standardized, as a basic approval on a cas e-by-case basis might incl ude preconditions that need to be addressed during the full-scale deve lopment and testing and eventually reported in connection with the applica tion 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 applicat ions 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 comp leteness of the applicati on and to facilitate the Groupís work.

4.10 In addition, for future applications, the a pplicant is requested to complete a key data summary table to enable the Group to have an ov erview of the properties of the product. A blank key data summary table has been developed by the Group for th is 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 discha rge of treated ballast water to the aquatic environment, the Group realised that inform ation was not available on basic assumptions regarding the likely vo lume of treated ballast water, the dur ation 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 Emi ssion 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- a nd long-term, for discharge of treated ballast water including doc umentation of appropriate models is needed. Considering the efforts needed for developing such ESDs, the Group decided that devel opment of an ESD for ballast water would not be possi ble 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 fo r a thorough evaluation of the environmental risks of discharge of ballast water.MEPC 54/2/12 ANNEX 1 Page 7

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I:\MEPC\54\2-12.doc 4.13 The Group also notes that several assessment factors (the value us ed to determine the PNEC from the no-effect concentr ation determined experimentally) are currently in international use. The Group intends to discuss asse ssment factors at the next meeting.

4.14 Section 2.3 of the Terms of Reference for th e 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 environmen t, which is not a requirement stated in the Procedure (G9).

4.15 The Group considered that toxi city of treated ba llast water at discharge needs special attention. Usually, 100% ballast water will contain active ingredients above the LC 50 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 wa ter enters the aquatic en vironment) 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 th e effects to the envi ronment as much as possible, based on the requirement of the PEC/PN EC ratio < 1 as an initial analysis, but the Group recommends the development of a tiered syst em in which an appropriate risk assessment may show that the substance can be safely appl ied without unacceptable risk s 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 do ssier submitted by Germany on the use of Peraclean Ocean as a biocide for treatment of ba llast 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 applic ation on board ships allowing an evaluation of the safety to ship and crew.

• Data on realistic occupational exposure scenar ios required in order to characterize human health risk of use and handling.

• Justification for use of scenarios for mode lling environmental exposure concentrations and assumptions and details of the modelling;

• Tests with treated ballast water on more species, includi ng long-term data.

• Justification for non-submission of data in ca ses where the data re quirements of G9 are not fulfilled.

• The application dossier does not include doc umentation of the quality-control/qualityassurance programme as reque sted in Procedure (G9): 4.2.4.MEPC 54/2/12 ANNEX 1 Page 8

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I:\MEPC\54\2-12.doc 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 furt her studies have been conducted. The matters of

concern were:

• Peraclean Ocean and the components of th e 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 be cause of the specific hazards associated with storage and use on board ship (e.g. movement of ship, vent ing of gases from the product, control of temperature, corrosion).

• A number of concerns in relation to safe ty of ships have been raised due to the physicochemical hazards of Peraclean Ocean. Th ese 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 th e main routes of concern: dermal and inhalation. These control measures (Personal Protective Equipment - PPE and Respiratory Protective Equipment - RPE) should be descri bed 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 availabl e information, the Group recommended that a basic approval be issued allo wing a further land-based devel opment and testing. During this phase, the above-mentioned concerns should be c onsidered. 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 s hould a full-scale on-board testing be initiated.

5.4 Before a final approval can be issued, a numbe r of issues need to be investigated and concluded on. These include:

• The Group recommended that dermal and inhala tion sub-chronic effects raised in some studies should be further investigated, taki ng into account realistic occupational exposure scenarios and covering non-accid ent situations. These data should be submitted before final approval. The irritation e ffects in the respiratory trac t triggered should be further investigated in a repeated-dose inhalation st udy 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 (d iluted 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 a nd this needed to be studied.

• There seems to be insufficient information on degradation of components of Peraclean Ocean, particularly hydrogen peroxide, during tr eatment of ballast water as it seems to depend on the content of organics and particle s in ballast water. This should be further studied and reliable estimates or measuremen ts of concentrations of the components at discharge should form the basis for the environmental risk assessment.

• Exposure modelling has been performed usi ng the MAMPEC model. The assumptions on the scenarios as we ll 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 requireMEPC 54/2/12 ANNEX 1 Page 9

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I:\MEPC\54\2-12.doc access to the input data and more information on the parameters within the model in order to ascertain the validity of the results. Justif ication for the use of the models needs to be provided.

• Based on the updated information, a revised envi ronmental risk assessment needs to be submitted for a final approval.

5.5 The evaluation report is include d 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 doe s not live up to the ba sic requirements as specified in the (G9) Procedure. In part icular, the following information is missing:

• Effects of the maximum total residual chlorine (TRC) concentration ( 20-30 mg/l) and also a quantitative risk assessme nt to the environment.

• Information on the reliability and accuracy of the control scheme.

• The dossiers do not provide any data on the co rrosivity of the treated ballast water.

• Data on human exposure to the active substanc es not allowing risk evaluation of use and handling.

• Justification of non submission of data.

• Calculation of the predicted environmental concentration (P EC) 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 acce ss 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 doc umentation of the quality control/quality

assurance programme as reque sted 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 furt her 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 seem s to be longer. It seems that the application of the ECS leads to creation of substa ntial amounts of very reactive species, in particular chlorine solu tions, 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) fo rmed during the electrolytic process result in concentrations in the treated ballast wate r 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 ma y be expected also at discharge of treated ballast water. In addition, th e potential health risk that may arise from human/mammalian exposure to chlorinated by-products have not been sufficiently characterized.MEPC 54/2/12 ANNEX 1 Page 10

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I:\MEPC\54\2-12.doc • The formation of chlorinated and brominated by-products is not sufficiently described. The Group is aware that plenty of studies have been cond ucted on formation of such products and their environm ental risks during electrolytic processes and during chlorination. This needs to be further studied.

• Acute aquatic toxicity tests have been c onducted with sea water to different species immediately after treatment with ECS. The test s showed that a diluti on 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 lik ely toxicity at discha rge should be further studied.

• Exposure modelling has been performed usi ng the MAMPEC model. The assumptions on the scenarios as we ll 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. Justif ication 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 docum entation of their properties should be included.

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

5.8 After a careful evaluation of the availabl e information, the Group recommended that a basic approval be issued allo wing a further land-based devel opment and testing. During this phase, the above-mentioned concerns should be c onsidered. 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 s hould a full-scale on-board testing be initiated.

5.9 Before a final approval can be issued, the risk s to ship, crew and the environment need to be further investigated and reported on based on the issu es mentioned above and any other information that is obtained duri ng the further development work.

5.10 The evaluation report is include d as annex 6 to this report.

6 MATTERS ARISING FROM RECENT IMO ACTIVITIES

The Group noted that the Admi nistrations of Sweden, Japan and Singapore have indicated their intention to submit proposal s for a basic approval of Activ e Substances during the coming months. The Group agreed to take this inform ation into account when considering its future programme under agenda item 8.MEPC 54/2/12 ANNEX 1 Page 11

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I:\MEPC\54\2-12.doc 7 CONSIDERATION OF QUERIE S FROM MEMBERS AND INDUSTRY

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

.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 orde r of the land-based testing, request for basic approval and shipboard testing?

.4 Is the Type Approval Certificate for Ba llast Water Management systems that use Active Substances issued by the Na tional Administration or by IMO?

7.2 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 shoul d 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 c ould be advised. The more results from testing, even from di fferent 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 refe rring 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.

8 FUTURE WORK PROGRAMME AND TENTATIVE DATE FOR THE NEXT MEETING

8.1 Based on the first experience with the ev aluation 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 ëa pplication dossierí 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 cas es, 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 creat e a well functioning system.

8.3 The Group further noted that the lack of gui dance 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 importa nt information. This had caused major difficulties for the Group in its evaluation of possible risk s to ships, crew and the environment. The conclusions of the Group should be seen in this context.MEPC 54/2/12 ANNEX 1 Page 12

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I:\MEPC\54\2-12.doc 8.4 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 stat es should evaluate and be satisfied with the state of the dossiers for compliance wi th 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 proce ssing applications within the timeframe specified for the activity of the Group. Provi ded 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 appli cants. However, the Group wants to reiterate once again that the level of detail in assessment under the proposed conditions is far below a scientifically satisfa ctory level as currently practised in similar international authorisation schemes.

• The Group would find it useful to have a cont act within the applic ant company to whom technical questions could be addressed during the Groupís m eeting, particularly relating to the ballast water management system.

9 CONSIDERATION AND ADOPTION OF THE REPORT

9.1 The Group adopted the report and the Chairm an thanked the members of the Group for their efforts.

9.2 At the conclusion of this first session, Mr. J.-C. Sainlo s, Director of the Marine Environment Division of the Or ganization 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 s hould tentatively be he ld 22-26 May 2006 to allow sufficient time for the evaluation, producti on of the report and submission to MEPC in accordance with the Guidelines on organiza tion 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.

* * *MEPC 54/2/12 ANNEX 1 Page 13

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I:\MEPC\54\2-12.doc 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 E-mail: fpe@mst.dk DK-1401 Copenhagen Tel: +45 32 660289 Denmark

Ms. Teresa Borges Senior Technical Officer General Health Directorate Alameda D. Afonso Henriques, 45 P-1049-005 Lisbon E-mail: tborges@dgsaude.min-saude.pt Portugal Tel: +351 218430593

Mr. Egil Dragsund Principal Marine Biologist Environmental and Te chnical Solutions Det Norske Veritas AS E-mail: egil.dragsund.dnv.com Veritasveien1 Tel: +47 67 57 8894 NO- 1322 H ̄vik Fax: +47 67 57 9911 Norway Mobile: +47 97 02 6956

Mr. Shinichi Hanayama Senior Research Fellow Maritime Technology Department Ocean Policy Research Foundation 1-15 Toranomon Minatoku-ku E-mail: s-hanayama@sof.or.jp Tokyo105-0001 Tel: +813 3502 1886 Japan Fax: +813 3502 2033

Mr. Jan Linders Expert in Environmental Risk assessment of Pesticides and Biocides RIVM-SEC P.O Box 1 E-mail: jan.linders@rivm.nl NL- 3720 BA Bilthoven Tel: +31 30 274 3164 Netherlands Fax: +31 30 274 4401MEPC 54/2/12 ANNEX 1 Page 14

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I:\MEPC\54\2-12.doc Mr. Celso Mauro Technical Consultant PETROBRAS -CENPES Av. Jequitib· 950 Cidade Universit·ria Ilha do Fund„o, Rio de Janeiro E-mail: cmauro@petrobras.com.br RJ CEP: 21941-598 Tel: +55 21 38656659 Brazil Fax: +55 21 38654975

Mr. David Tongue Marine Manager International Chamber of Shipping E-mail: david.tongue@marisec.org 12 Carthusian Street Tel: +44 2074718844 London EC1M 6EZ Fax: +44 2074178877 United Kingdom Mobile: +44 (0)7855391258

IMO ñGESAMP CONSULTANTS

Dr. Mel Cooke Director Alchemy Compliance Ltd. 7 Western Fields Ruddington E-mail: info@alchemycompliance.com Nottinghamshire NG11 6JE Tel: +44 115 878 1489 United Kingdom Fax: +44 115 8781489

Dr. Manfred Nauke Technical Adviser to IMO Marine Environment Division 16 Green Bank Woodside Avenue E-mail: manfrednauke@aol.com London N12 8AS Tel: +44 208 445 7958 United Kingdom

IMO SECRETARIAT

Mr. Dandu Pughiuc IMO Technical Secretary to GESAMP/BWWG International Maritime Organization Marine Environment Division 4 Albert Embankment E-mail: dpughiuc@imo.org London SE1 7SR Tel: +44 (0)20 7587 3247 United Kingdom Fax: +44 (0)20 7587 3261MEPC 54/2/12 ANNEX 1 Page 15

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I:\MEPC\54\2-12.doc Mr. RenÈ Coenen IMO Technical Secretary to GESAMP International Maritime Organization Marine Environment Division 4 Albert Embankment E-mail: rcoenen@imo.org London SE1 7SR Tel: +44 (0)20 7587 3239 United Kingdom Fax: +44 (0)20 7587 3261

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

AGENDA FOR THE FIRS T SESSION OF THE BALLAST WATER WORKIN G GROUP OF GESAMP

1 Introduction

2 Issues of confidentiality

3 Terms of Reference

4 Development of a draft methodology for info rmation gathering in accordance with the Procedure for Approval of BWM that ma kes use of Active Substances (G9)

5 Review of proposals for approval of Activ e Substances submitted by Germany and the Republic of Korea

6 Matters arising from IMO and other Organi zations relevant to the activity of the GESAMP-BWWG

7 Consideration of queries from memb ers and industry related work of the GESAMP-BWWG

8 Future work programme and tent ative date for the next meeting

9 Consideration and adoption of the report

* * *MEPC 54/2/12 ANNEX 1 Page 17

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I:\MEPC\54\2-12.doc ANNEX 3

TERMS OF REFERENCE FOR THE GESAMP-BALLAST WA TER 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.

2 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, th e Group shall undertake the:

.1 Scientific evaluation of the data se t 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, in vertebrates, 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 a nd effect aerobic and anaerobic:

- modes of degradation (biotic, abiotic) - bioacculumation, octanol/wat er 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 -flammabilityMEPC 54/2/12 ANNEX 1 Page 18

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I:\MEPC\54\2-12.doc -density -water solubility, diss ociation 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 te sting procedures must contain rigorous quality control/ quality assu rance 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 toxi city testing procedures with treated ballast water, i.e.:

-acute aquatic toxicity:

short term L(E) C x from freshwater or saltwater representatives of algae, crustacean and fish

-chronic toxicity:

long-term NOECS or EC x, algae, crustacean and /or fish or other relevant species representing at l east 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 circumst ances (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 th e risk characterisation and analysis in the proposal for approval:

-Evaluate potential impact in regard to:MEPC 54/2/12 ANNEX 1 Page 19

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I:\MEPC\54\2-12.doc ! toxicity of Active Substances in treated ballast water and BW discharges

! production of free radicals, production rates

! route of abiotic and biotic degradat ion, identify degradation rates under specified conditions, e.g. pH, redox, temperature

-determine solid-water partition co-efficient (K d ), and/or organic carbon normalised distribution coefficient (K OC ) -assess the potential for bioaccumulation in marine or freshwater organisms if log P OW is >3

-predict discharge concentrations at selected time intervals

- effects of Active Substances etc. on primary producers (algae) consumers (crustaceans) and pred ators (fish) as well as secondary poisoning of mammalian and avian top-predators

-in case of lack of bioconcentrati on potential (BCF <500 L/μg), an assessment of secondary poisoning is redundant

- in case the potential for partiti on into the sediment is low (e.g. K OC <500 L/ μg) an assessment of sediment species is redundant

-effect assessment shall include th e screening on carci nogenic, mutagenic and endocrine disruptive properties

-effect assessment should be base d 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

3 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 in to account also handling, storage and application requirements.

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

* * *MEPC 54/2/12 ANNEX 1 Page 20

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I:\MEPC\54\2-12.doc ANNEX 4 

## Draft Methodology for Information Gathering in Accordance with the ëProcedure for Approval of BWM Systems that Make Use of Active Substances G9í

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

2 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 a nd non-submission of data .................................................26

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

3 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/biomagnifica tion/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 repr oductive toxicity ........................................................30

3.3.6 Carcinogenicity ................................................................................................30

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

3.3.8 Toxicokinetics..................................................................................................31MEPC 54/2/12 ANNEX 1 Page 21

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I:\MEPC\54\2-12.doc 3.4 Data on environmental fate a nd 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 meta bolites 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, % partic ulate matter.....................................................................35

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

3.6 Analytical methods at environmentally re levant concentrations (G9: 4.2.1.5)........35

3.6.1 Analytical methods at environmen tally relevant concentrations .....................35

4 Use of the Pr eparation......................................................................................................35

4.1 The manner of application .......................................................................................35MEPC 54/2/12 ANNEX 1 Page 22

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I:\MEPC\54\2-12.doc 5 Material Safety Data Sheets.............................................................................................36

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

6.1 Screening for persistence, bioaccumu lation and toxicity (G9: 5.1) .........................36

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 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

7 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

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

9 Final approval ................................................................................................................. .42MEPC 54/2/12 ANNEX 1 Page 23

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I:\MEPC\54\2-12.doc This document gives the responsibility of the app licant 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 C onvention for the Control and Management of Shipsí Ballast Water and Sediments, 2004.

.2 Ballast Water Management means mechanical, physical, chemical and biological processes - either singularly or in combin ation - to remove, render harmless, or avoid the uptake or discha rge of Harmful Aquatic Organisms and Pathogens within Ballast Water and Sediments.

.3 General obligation of the Convention means, ìParties undertake to give full and complete effect to the provisions of th is Convention and the Annex thereto in order to prevent, minimize and ultimatel y eliminate the transfer of Harmful Aquatic Organisms and Pathogens through th e control and management of shipsí Ballast Water and Sediments.î (Article 2, para. 1)

.4 Active Substances means Active Substances or Pr eparations containing one or more Active Substances used to comply with the Convention.

.5 Basic Approval means the approval of a compre hensive 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. Wh en considering the comprehensive proposal, the Group shall take a ccount 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 Scien tific 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 thei r individual capacity.

.7 Final Approval means a review of the Basi c Approval, supplemented with additional data regarding operational pr actices on board ships and discharge testing data from the field, i.e. in ports a nd harbours, estuaries, coastal zones, etc.. The Final Approval shall also confirm that previous evaluations of risks to ship and crew including storage, handling and a pplication of active substances remain valid.

.8 Experimental application period ñ In maximum, five year s (according to G10), after the issue of Basic Approval, the Me mber of the Organization concerned shall submit a report to the Organization summarizing the results gained with the experimental application of the Active S ubstance, as well as any consequencesMEPC 54/2/12 ANNEX 1 Page 24

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I:\MEPC\54\2-12.doc that had to be taken into account in impr oving the system. This report will include all non-confidential and public information.

A comprehensive report comprising all data re sulting from the experimental application, including the confidential information will be submitted to the Organization for evaluation by the GESAMP-BWWG following the procedure for Basi c Approval. The Group shall report through GESAMP to MEPC confirming that the residual t oxicity conforms to th e evaluation undertaken for Basic Approval

2 General

2.1 Legal provision Regulation D-3.2 of the Internat ional Convention for the Contro l and Management of Shipsí Ballast Water and Sediments, 2004, stipulates th at 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 Envi ronment Protection Committee (MEPC) adopted the Procedure fo r approval of Ballast Water Ma nagement 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 accomplis h their intended purpose through action on Harmful Aquatic Organisms and Pathogens in shipsí ballast water and sediments. However, if the ballast water is still toxic at the time of discharge into the environment, the organisms in the receiving water may suffer unacceptable harm. Both the Activ e Substance or Preparation as well as the Ballast Water Discharge should be subjected to toxi city 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 environmen t 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 an d the personnel to comply with the Convention (G9: 3.3).

2.3 Data submission Procedure to be followed: Th e manufacturer should evaluate the Active Substances or Preparations and the potential discharge in accord ance with the approval criteria specified below (G9: 8.1.2.1). Upon completion, the manufacturer s hould 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: Th e Director, Marine Environment Division, International Maritime Organization, 4 Albert Embankment, London SE1 7SR, United Kingdom

Application requirements:

• Complete application including all documents below (one pa per version), including full study reports and full copies of literature . The complete application should contain a contents list indicating the lo cation of the information in the application. The order in which the information is presen ted, including overall structure such as how information is presented for the active substance, preparati on, ballast water, risk assessment, assessment report, should follow this format, includi ng its numbering, which is based on G9MEPC 54/2/12 ANNEX 1 Page 25

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I:\MEPC\54\2-12.doc • Non-confidential summary document (as provid ed to MEPC) to provide an overview of the application (electronic version)

• A summary of the key data shou ld be provided in a tabular format (electronic version)

• The assessment report (electronic version)

Dossiers already used for registratio n 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 th e 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 manufactur ers 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 re garded as dangerous according to the UN GHS or relevant IMO regulations and cont ribute to the hazard documentation of the preparation

• Physical and chemical data concerning the Active Substance and preparation

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

• Recommended methods and precau tions 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 give n in the case of injury to persons.

2.5 Test Methods Tests should be carried out by internationall y recognized guidelines (preferably OECD or equivalent) (G9: 4.2.3), and according to an intern ationally recognised quali ty assurance system (G9: 4.2.4) (eg GLP). Information may be derived from existing data wh ere an acceptable justification is provided. Full copies of sources of data (eg lite rature papers) should be provided. Care should be taken to provide full supporting references and c opies of the appropriate test laboratory reports in support of each applica tion. Submissions that are lacking relevant information may not be accepted for risk asse ssment. 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 s ubmission of all availabl e end-point data for Active Substances and relevant chemicals.MEPC 54/2/12 ANNEX 1 Page 26

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I:\MEPC\54\2-12.doc 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 a nd 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 na ture of the substance or of its proposed uses and taking into account all proposed risk manageme nt measures need not be supplied. The same applies where it is not scientif ically necessary or t echnically possible to supply the information. In such cases a justification must be submitted.

2.7 Procedures and timelines The procedures for evaluation of the dossi er are given in the Appendix to G9. If in the course of the revi ew by the Ballast Water Working Group it becomes evident that additional data is found to be necessary to fi nalize the evaluation, the Group may request that such data is submitted. The applicant will be informed in writing of th e decision of the Organization. The applicant may appeal against any decision made by the Organiza tion. The Organization will consider the appeal and respond in writing to the Member of the Organization. It may be useful for a technica l representative of the company to be available to the BWWG for an hour or so to answer que stions regarding the system.

3 Data-set required in the application The dossier should contain the information speci fied in G9. Non-submission of information should be justified. For active substances and/or prep arations as appropriate, data on properties should be included. For other components in preparations that may cont ribute 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 pr ovide 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 addres s the sensitive life stage (G9: 5.2.4). The results should include acute LC 50 values and NOECs, and chronic NOECs or EC 50 s (G9: 5.2.5). Theref ore 100% ballast water discharge should be tested (G9: 5.2.6), if appropriate.

3.1 Identification of the substa nce 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; so lids in %w/w; gases in %v/v ), including CAS numbers and chemical names

• UN number and nameMEPC 54/2/12 ANNEX 1 Page 27

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I:\MEPC\54\2-12.doc 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, invert ebrates and fish, and other biota, including sensitive and representative organisms (G9: 4.2.1.1)

For every Active Substance or preparation data s hould be presented and di scussed either on the basis of toxicological tests or existing toxi cological knowledge for each end point listed.

3.2.1 Acute aquatic toxicity Short-term L(E)Cx from freshwater or saltwater 1 representatives of three taxonomic groups (algae, crustaceans and fish) representing thre e trophic levels (OECD guidelines 201 (Algae, Growth Inhibition Test), 202 (Daphnia sp. Ac ute 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 es tablished guidelines) shall be accepted. To reduce further any remaining uncertaint y, applicants should preferably also submit data for two additional marine taxonomi c 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 tr ophic levels (e.g. Fish: OECD 210, 215, or 212; Daphnia: OECD 211). To reduce further any remaini ng uncertainty, applicants should preferably also submit two long-term NOECs from additio nal marine taxonomic groups (e.g. echinoderms, molluscs). In case of whole effluent testing, EPA short term methods for estimating th e chronic toxicity of substances and discharge provide acceptable alternatives, since the identification of the sensitive sub-lethal endpoints and vulnerabl e 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 environm ents 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.MEPC 54/2/12 ANNEX 1 Page 28

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I:\MEPC\54\2-12.doc 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 a ssessment for each compartment of relevance. If there is no indication for endocrine disruption ñ e.g. due to the structure of the substance or results of other available studies ñ these tests may be waived. 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 sedime nt-dwelling organisms. Testing is required only if log K ow > 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/biomagnif ication/bioconcentration If log P ow > 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 ( k 1 / k 2 ). 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, mammalia n 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 biodegradationMEPC 54/2/12 ANNEX 1 Page 29

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I:\MEPC\54\2-12.doc data. An assessment of secondary poisoning is re dundant if for the substance of concern absence of bioaccumulation potential can be demonstrat ed (BCF <500 L/kg wet weight for the whole organism at 6% fat). If not, testing should include:

• One long-term NOECs based on reproduc tion 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, sc reening tests negative, appropriat e risk management measures are in place - see also point 2 above). In such case s a justification must be submitted. Lack of data with missing justification will in general not allow any approval. If available, human experience or epidemiol ogical 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 gase s or produce vapours during the use should be tested by inhalation. The submission of de rmal and/or inhalation studies instead of or in addition to oral studies may be required de pending 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 w ith 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 minimi zed. Tests should be performed with the Active Substance(s). Testing of Active Substances or Prepara tion should include a study on acute dermal irritation/corrosion and a study on acute eye irritation/corrosi on. The recommended tests are OECD guidelines 404 (Acute Dermal Irri tation/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 Preparat ion 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 Sensitizati on is OECD guideline 406. While the guinea-pig Maximization test is considered to be the prefe rred 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 wh en either of the two latter mentioned is used. The test is not needed if the Active Substance or Preparation is alre ady classified in an internationally recognized system or otherwise known as a sensitizer. PreparationMEPC 54/2/12 ANNEX 1 Page 30

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I:\MEPC\54\2-12.doc Active substance Information on other components Relevant chemicals

3.3.3 Repeated-dose toxicity A 90-day sub-chronic toxicity st udy 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 ñ Two-Generation Reproduction Toxicity Study)

• A prenatal developmental toxicity (ter atogenicity) study in two species (OECD guideline 414 - Prenatal Deve lopmental Toxicity Study).

However, these key data requirements can be modified (either reduced or accelerated or extended) and influenced by factors such as st ructural relationships with a known reproductive toxicant, the results of other toxicity studies (incl. toxic okinetics), 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 perfor med with one rodent and one other mammalian species. The carcinogenicity testing of an Active Substance or preparati on may not be required where justification demonstrates that these tests are not necessa ry. 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 availa ble for Active Substances or pr eparations from at least three tests: a bacterial gene mutation test, an in vitr o mammalian cell cytogenicity study and an in vitro mammalian cell gene mutation assay. In case of positive or equivocal results, further in vivoMEPC 54/2/12 ANNEX 1 Page 31

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I:\MEPC\54\2-12.doc mutagenicity testing with bone marrow assay for chromosomal damage or a micronucleus test is necessary. If this test is negative it should be ev aluated 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 Substa nces 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 tes ting. The potential for dermal absorption should be eval uated 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 sh ould be assessed, resulting in th e identification of relevant metabolites in the relevant media (ballast wa ter, marine and fresh waters) (G9: 5.3.4). The partition coefficients [solids-water partition coefficient (K d ) and/or organic carbon normalized distribution coefficient (K oc )] of the Active Substa nces, other components and Relevant Chemicals should be determined (G9: 5.3.6). The data submitted in accordance with this pa ragraph should clarify, in addition to the degradation of the substance, other relevant rout es of dispersion in and from water, such as volatilization, adsorption, sedime ntation and transformation into bound residues. Accordingly the exposure of organisms living in water a nd 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 unde r 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 (B iodegradability in Seawater) or equivalent guidelines if the Activ e Substance is discharged only into marine

water

• Studies on ready biodegradability according to OECD guideline 301 (or equivalent guidelines) and OECD guideline 306 (or equiva lent guidelines) if the Active Substance is discharged into estuarine water (e.g. inland harbour w ith contact to seawater).

If the Active Substance is not readily biodegradable, then the fo llowing higher ti er studies are

necessary:

• A study on aerobic and anaerobic transformation in aquatic sediment systems according to OECD guideline 308 (Aerobic and Anaerobi c Transformation in Aquatic Sediment Systems) or equivalent guidelines if Ko c >500 L/kg, using fresh or marine waterMEPC 54/2/12 ANNEX 1 Page 32

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I:\MEPC\54\2-12.doc depending on kind of aquatic ecosystem where discharge is intended. At least one system with high organic matter/nutrient content and one with low or ganic matter/nutrient content should be tested (see above)

• A study on aerobic transformation of low con centrations of organic contaminants according to OECD guideline 309 (Aerobic Mine ralization in Surface Water - Simulation Biodegradation Test) or equivale nt guidelines, using fresh or marine water depending on the kind of aquatic ecosystem where discharge is intended

• Where relevant, a study on photo-transformati on 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 OE CD 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 Ri sk Assessment (2003) for at least three inocula, including freshwater se diment, 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 matte r of the medium, viz. standardization to K oc . This is only valid for non-ionic substances . For ionic substances the K p values and the test characteristics (%clay, CEC, %o.c., pH) should be reported. Active substance Partition coefficient n-octanol/w ater 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 chemicalsMEPC 54/2/12 ANNEX 1 Page 33

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I:\MEPC\54\2-12.doc 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 halogenate d (chlorinated, brominated) hydrocarbons which may be of concern to environmenta l or human health, in the presen ce of organic matter. For these substances, the freely and othe rwise reasonably available inform ation should be presented and discussed in relation to the proposed manner of app lication, 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 pr operties also required la ter. Further guidance can be found in the MEPC approved hazard eval uation 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 sa fety and the level of residues that may be tolerated in seafood. Any availabl e 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 balla st 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, th eir preparations, the tr eated 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 componentsMEPC 54/2/12 ANNEX 1 Page 34

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I:\MEPC\54\2-12.doc 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 (pK a ) Information on other components Relevant chemicals Water solubility and dissociation constant

3.5.7 Oxidation/reduction potential Preparation Active substance Ballast water also ëredoxí for ballast water us ed in type approval testing

3.5.8 Corrosivity to the materials or equi pment 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 substanceMEPC 54/2/12 ANNEX 1 Page 35

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I:\MEPC\54\2-12.doc 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 environmenta lly relevant concentrations (G9: 4.2.1.5)

3.6.1 Analytical methods at environm entally relevant concentrations Preparation Active substance Analytical methods for the detect ion of Active Substances in di scharge 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 detec tion of Relevant Chemicals in di scharge 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 applicat ion of the prep aration 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 dossi er should contain the n ecessary data addressing the following items:MEPC 54/2/12 ANNEX 1 Page 36

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I:\MEPC\54\2-12.doc • The technical manual or instructions by the manufacturer, in cluding the product specification, process description, operati onal instructions, details of the major components and materials used, technical inst allation specifications, system limitations, and routine maintenance should be provided (BWWG), including quantit y to be added to ballast water and maximum concentrati on 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 decontaminati on 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) shoul d be described. These management measures are an integral part of the Ballast Water Management System a nd 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 techni cal guidance document has been prepared for the United Nationsí Globally Harmonized System of Classificat ion and Labelling of Chemicals (GHS) to aid in interpreting data for cl assifying substances as dangerous. Reference is also made to the MEPC approved hazard eval uation procedure published as GESAMP Reports and Studies No. 64 under the title ëThe Revi sed GESAMP Hazard Evaluation Procedure for Chemical Substances Carried by Shipsí, 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 thes e should be summarised in the Key Data Summary Table.

6 Risk Characterisation

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

6.1.1 Persistence (G9: 5.1.1.1) Persistence is preferably asse ssed 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 a ssessment of relevant chemicals.MEPC 54/2/12 ANNEX 1 Page 37

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I:\MEPC\54\2-12.doc For persistence and degradation data require ments, see 2.4.1 and 2.4.3 of this document.

6.1.2 Bioaccumulation (G9: 5.1.1.2) The assessment of bioaccumula tion potential should use measured bioconcentration factors in marine (or freshwater organisms). Where te sts are not applicable, or log Pow <3, the bioconcentration factor may be estimated usi ng 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 requiremen ts, see 2.2 of this document. It is necessary to consider, wh ether 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 prep aration meet all th ree criteria for PBT ? See G9: Table 1

Table 1 Criteria for identific ation of PBT substances Criterion 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 sediment a Bioaccumulation If Log P octanol/water ≥ 3, then experimental BCF required. BCF > 2,000 Toxicity Chronic NOEC < 0.01 mg/l

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

Active Substances or Preparati ons 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 wa ter discharge is that it integrates and addresses the potential by-products of the formulati on and interactions with the system.

6.2.1 Basic approval Testing should be performe d in laboratory (G9: 5.2.1)

6.2.2 Final approval Discharge test with w hole 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 C onvention (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 Approva l tests in accordance with Guidelines for Approval of Ballast Water Management System s. The results should be conveyed to theMEPC 54/2/12 ANNEX 1 Page 38

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I:\MEPC\54\2-12.doc 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 w ith Regulation D-3.2. Ac tive Substances or Preparations that have receive d Basic Approval by the Organizati on may be used for evaluation of Ballast Water Management systems using Ac tive 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 parame ters and toxicity should be used to determine the amount of time needed to hold the treate d 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 characterisati on 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 substan ces 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 persis tence 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 shoul d be predicted (G9: 5.3.8).

6.3.4 Assessment of potential for bioaccumulation For Active Substances and Preparations, the pote ntial for bioaccumulation should be assessed in marine or freshwater organisms (fish or biva lves) 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, Pr eparations and Relevant Chemicals is initially based on a dataset of acute and/or chronic ecotoxi city data for aquatic organisms, being primary producers (algae or sea grasses), consumers (crust aceans), predators (fish) , and should include secondary poisoning to mammalian and avian top-pred ators, as well as data for sediment species (G9: 5.3.9).

In the effect assessment only toxicity studies re porting on dietary and oral exposure are relevant, as the pathway for secondary poisoning refers ex clusively 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 correlati ons between laboratory bird species and marine predatory bird species and betw een laboratory mammals (e.g. rats) and the considerably larger marine predatory mammals. An assessment of secondary pois oning is redundant if the substance of con cern 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).MEPC 54/2/12 ANNEX 1 Page 39

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I:\MEPC\54\2-12.doc 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, Pr eparations 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 co ncerns, this should give rise to a further effect assessment (G9: 5.3.12).

Effects on aquatic organisms Considering the deliberate discharge of Active S ubstances and/or relevant chemicals into the environment, where only data for algae, crustacean s and fish is available, for the derivation of a predicted no effect concentration in salt water (PNEC saltwater ) a higher assessment factor than that for the derivation of predicted no effect concentration in fresh water (PNEC freshwater ) should be applied, to reflect the greater uncertainty in protecting sensitive species in saltwater environments. Where data is available for addi tional 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-Crite ria and being rapidly degradable , the PNEC could be set along the background concentration in the environmen tal 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 circumstan ces where expert judgme nt 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 justificat ion must be provided.

Table 2 Effect assessment for deriving PNEC s for freshwater and saltwater

Data set Assessment factor

Freshwater assessment Lowest chronic NOEC from three freshwater or saltwater species representing three trophic levels 10

Saltwater assessment Lowest chronic NOEC from three freshwater or saltwater species representing three trophic levels 100

Lowest chronic NOEC from three saltwater species representing thr ee trophic level [10, 100]

Lowest chronic NOEC from three freshwater or saltwater species representing three trophic levels + at least two chronic NOECs from additional marine taxonomic groups 10MEPC 54/2/12 ANNEX 1 Page 40

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I:\MEPC\54\2-12.doc 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 l ong-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 intern ationally accepted the results from any tests should always be evaluated with caution.

Table 3 Effect assessment for deriving PNECs for sediment

Data set Assessment factor

Freshwater assessment Three chronic sediment tests with species representing different living and feeding conditions 10

Saltwater assessment Three chronic sediment tests with species representing different living and feeding conditions 50

Lowest chronic NOEC from three freshwater or saltwater species representing different living and feeding conditions including at least two chronic NOECs from marine species 10

6.3.6 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 unexpect ed 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 compartmen t 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 asse ssment 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.MEPC 54/2/12 ANNEX 1 Page 41

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I:\MEPC\54\2-12.doc 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 fa ctors, distribution etc. ñ the OECD Emission Scenario Document for Antif ouling 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 derive d, a qualitative risk char acterization should be conducted.

Risks to human health The human health risk assessment should follo w generally accepted guidelines including acute and long-term exposure situations. The risk assessm ent shall entail hazard identification and, as appropriate, dose (concentration) ñ response (effect) assessment , exposure assessment and risk characterization. The population gr oups at risk to be examined should include crew, passengers, as well as personnel and the public in ports. Potential health risk s 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 e quipment). The evaluation of the risks to human health should include risk redu ction (risk management) by regulations based on the SOLAS Convention as well as specific measur es proposed by the manufact urer 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, proper ty (e.g. ship) or resources (e.g. fisheries) in accordance with section 6 of the Procedure

• If any monitoring has been conducted, a summ ary of the results of that monitoring, including information on the analytical me thodology used, ship movements and a general description of the area monitored

• A summary of the available data on envi ronmental exposure and any estimates of environmental concentrations developed through the application of mathematical models, using all available environmental fate pa rameters, preferably those which were determined experimentally, along with an id entification or description of the modelling methodology

• An evaluation of the association between th e Ballast Water Management System making use of Active Substances or preparations co ntaining one or more Active Substances to comply with the Convention in question, the related adverse effects and the environmental concentrations, either observe d or expected based on the risk assessment and the effluent testing

• A qualitative statement of the le vel of uncertainty in the ev aluation referred to under the preceding paragraph

• A detailed description of ri sk management possibilities, e.g. for neutralization of theMEPC 54/2/12 ANNEX 1 Page 42

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I:\MEPC\54\2-12.doc 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 Memb er of the Organization. The Member of the Organization should inform the Or ganization accordingly (G9: 8.4.1). Manufacturers intending to significa ntly change any part of a Ba llast 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.MEPC 54/2/12 ANNEX 1 Page 43

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

# Key Data Summary Form for the ëProcedure for approval of BWM systems that Make Use of Active Substances (G9)í

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 th e 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 id entification 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 chem icals (IUPAC name, CAS number):

Section 2: Effects on aquatic organisms (G9: 4.2.1.1 ) Acute aquatic toxicity Test substance Species (eg fish, Daphnia, algae) Effect (L(E)C 50 ; duration) Value (units); range Reference/ comments

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

Data waivers for acute aquatic toxicity Species Test substance Test Reason for not supplying the dataMEPC 54/2/12 ANNEX 1 Page 44

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I:\MEPC\54\2-12.doc Chronic aquatic toxicity Test substance Species (eg fish, Daphnia, algae) Effect (NOEC; duration) Value (units); range Reference/ comments

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

Data waivers for chronic aquatic toxicity Species Test substance Test Reason for not supplying the data

Information on endocrine disruption Substance Information on endocrine disruption Preparation Active substance Other components (1, 2, 3) Relevant chemicals Other

Sediment toxicity Test substance Species (eg fish, Daphnia, algae) Effect [L(E)C 50 ; duration; NOEC] Value (units); range Reference/ comments Preparation Active substance Other components (1, 2, 3) 1. 2. 3. Relevant chemicals Ballast water Other

Data waivers for sediment toxicity Test substance Species Test Reason for not supplying the dataMEPC 54/2/12 ANNEX 1 Page 45

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I:\MEPC\54\2-12.doc Bioavailability/biomagnification/bioconcentration Substance Log P ow BCF Cause for

concern (yes/no) Reference/Comments

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

Food web/population effects Substance Cause for

concern (yes/no) Comments

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

Section 3: Data on mamma lian toxicity (G9 4.2.1.2)

Acute Toxicity

Substance Species Method guidelines Route; dose levels; duration of exposure Endpoint [Oral LD 50 ; Dermal LD 50 ; Inhalation LC 50 ] Value (units) Reference/ Comments

Preparation

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

3. Relevant chemicals OtherMEPC 54/2/12 ANNEX 1 Page 46

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

Substance Species Method guidelines Average score (24, 48, 72 h) Reversability (yes/no) Result Reference/ Comments

Preparation

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

3. Relevant chemicals Other

Eye Irritation

Substance Species Method guidelines Average score (24, 48, 72 h) Reversability (yes/no) Result Reference/ Comments

Preparation

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

3. Relevant chemicals Other

Skin sensitization

Substance Species Method guidelines (Buehler, M&K) Sensitiser (y/n) Reference/Comments

Preparation

Active substance Other components (1, 2, 3) 1. 2. 3. Relevant chemicals OtherMEPC 54/2/12 ANNEX 1 Page 47

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I:\MEPC\54\2-12.doc Repeated-dose toxicity

Substance Species Method guidelines Route; Duration of study; dose levels and frequency of application Results NOAEL; NOEL (units); range Reference/ Comments

Preparation

Active substance

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

3. Relevant chemicals Other

Data waivers for repeated-dose toxicity Test substance Test; species; route of exposure Reason for not supplying the data

Developmental and reproductive toxicity

Substance Species Method guidelines Route; Duration; doses Effects; NOAEL maternal toxicity; NOAEL embryotoxicity; NOAEL parental; NOAEL F1; NOAEL F2 (units); range Reference/ Comments

Preparation

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

3. Relevant chemicals Other

Data waivers for developmen tal and reproductive toxicity Test substance Test; species; route of exposure Reason for not supplying the dataMEPC 54/2/12 ANNEX 1 Page 48

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I:\MEPC\54\2-12.doc 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, 2, 3) 1. 2.

3. Relevant chemicals Other

Data waivers for mutagenicity/genotoxicity Test substance Test; Species; route of exposure Reason for not supplying the dataMEPC 54/2/12 ANNEX 1 Page 49

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I:\MEPC\54\2-12.doc Section 4: Data on environmental fate and effect under aerobic and anaerobic conditions (G9: 4.2.1.3)

Modes of degradation (biotic; abiotic)

Hydrolysis at pH 5, 7, 9 Test substance Test; duration pH; temp Value (units); half life Reference/ comments Active substance Other components (1, 2, 3) 1. 2. 3. Relevant chemicals Other

Data waivers for hydrolysis Test substance Test Reason for not supplying the data

Biodegradability Test substance Test type; duration;

sea- /freshwat

er Readily biodegradabl e (y/n) Value (units); half life Identification of breakdown products Reference/ comments

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

Data waivers for biodegradation Test substance Test Reason for not supplying the dataMEPC 54/2/12 ANNEX 1 Page 50

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I:\MEPC\54\2-12.doc Partition coefficients Test substance Coefficient (P ow ; K oc ; other) Test method; pH; temp Value (log units) Reference/ comments

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

Data waivers for partition coefficients Test substance Test Reason for not supplying the data

Persistence and identification of the main metabolites Test substance Test; duration pH; temp Value (units); half life Reference/ comments Active substance Other components (1, 2, 3) 1. 2. 3. Relevant chemicals Other

Data waivers for persistence and identification of the main metabolites Test substance Test Reason for not supplying the data

Reaction with organic matter Test substance Discussion of the reaction, including formation of hazardous byproducts Reference/ comments Active substance Other components (1, 2, 3) 1. 2. 3. Relevant chemicals OtherMEPC 54/2/12 ANNEX 1 Page 51

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I:\MEPC\54\2-12.doc Potential physical effects on w ildlife and benthic habitats Test substance Physical description (state, solubility, viscosity) Discussion of potential effects Reference/ comments

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

Potential residues in seafood Test substance Monitoring data/residues Impact on consumer safety Reference/ comments Preparation Active substance Other components (1, 2, 3) 1. 2. 3. Relevant chemicals Other

Any known inter active effects Test substance Interaction with other chemicals, BWS, or receiving environment Discussion of potential effects Reference/ comments

Active substance Other components (1, 2, 3) 1. 2. 3. Relevant chemicals Ballast water OtherMEPC 54/2/12 ANNEX 1 Page 52

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I:\MEPC\54\2-12.doc Physical and chemical properties for the active s ubstances and preparations and treated ballast water, if applicable (G9: 4.2.1.5)

Property (with units and reference) Preparati

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

Melting point (°C) 1. 2. 3. Boiling point (°C) 1. 2. 3. Flammability (flash point for liquids; °C) 1. 2. 3. Density (20 °C; kg/m 3 ) Vapour pressure (20 °C; Pa) 1. 2. 3. Vapour density (air = 1) 1. 2. 3. Water solubility (temp; effect of pH; mg/l) 1. 2. 3. pH in solution Dissociation constant (log K oc ) 1. 2. 3.Oxidationreduction potential Corrosivity to material or equipment 1. 2. 3. Reactivity to container material Autoignition temperature (°C) Explosive properties Oxidising properties Surface tension Viscosity Thermal stability and identity of breakdown productsMEPC 54/2/12 ANNEX 1 Page 53

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I:\MEPC\54\2-12.doc Other physical or chemical properties 1. 2. 3. Shaded cells, data not required Salinity, TOC, DOC, and % particulate matt er are required for the ballast wate r 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 Preparation Active substance Other components (1, 2, 3) 1. 2. 3. Other

Risk characterisation Substance Persistent (y/n) Bioacumulative (y/n) Toxic (y/n) Reference/ comments Preparation Active substance Other components (1, 2, 3) 1. 2. 3. Relevant chemicals Other

Evaluation of the treated ballast water Conclusion of the half-life of the toxicity of the treated ba llast water, and the recommended holding time.

Risk characterisation Conclusion on the effects of reaction with organic matter

Conclusion of persistenceMEPC 54/2/12 ANNEX 1 Page 54

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

* * *MEPC 54/2/12 ANNEX 1 Page 55

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I:\MEPC\54\2-12.doc ANNEX 5

REVIEW OF PROPOSALS FOR APPRO VAL OF ACTIVE SUBSTANCES - SUBMITTED BY GERMANY (PERACLEAN OCEAN)

The basis for the groupís evaluation of PERACLEAN OCEAN was the application dossier submitted by Germany. No furthe r 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 scenar ios are required in order to characterize human health risk of use and handling.

• Justification for use of scenarios for mode lling environmental exposure concentrations

• Tests with treated Ballast Water on mo re species, including long-term data

• Justification for non-submission of data

2 Identity

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

• Peracetic acid (PAA) [79-21-0] H 3 CñC(=O)-O-OH 14 - <17%

• Hydrogen peroxide [7722-84-1] HñOñOñH 13 - <15%

• Acetic acid [64-19-7] CH 3 -COOH 24 - <29%

• Water H 2 O <39 - 49%

Peracetic acid is the Active Substance, whic h is in a dynamic equilibrium with hydrogen peroxide in both the formulated pr eparation and in ballast water du ring use. Peracetic acid is a strong oxidising agent with a non-specific mode of action.

PERACLEAN OCEAN is specifi ed as scheduled in the IMDG Code under UN No. 3109, organic peroxide Type F, liqui d, with a classification of 5.2.MEPC 54/2/12 ANNEX 1 Page 56

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

Property PAA H 2 O 2 Acetic acid Molecular weight 76.05 34.02 60Physical state Clear, colourless liquid Clear, colourless liquid Clear, colourless liquid Melting point [  ̊ C] -50 -0.40 -16 Boiling point [  ̊ C] > 60 150 (d) 100 (Relative )density [kg/m 3 ] 1150 1442.5 1050

Vapour pressure [Pa] 1.1 10 -5 300 1570 Solubility [g/L] 1000 Miscible Miscible Log Kow -0.52 -1.5 -0.23 pKa 8.2 11.62 Viscosity Henryís law constant 5 10 -12 4.5 10 -6 5.4 10 -4 Flash point [  ̊ C] 96 40 Autoignition temperature [  ̊ C] 265 485

Flammability Flammable Explosive properties Not explosive

3 Application

The recommended application of PERACLEAN OC EAN is a concentration of 150 mg/L in the ballast water for a minimum period of 1 da y and for preferably a period of 2 days.

The submission informs PERACLEAN OCEAN is app lied to the ballast water by an automated dosing system that addresses the va riations in flow rates of balla st pumps. The product is dosed after a two stage filtration process designed for pre-separation of solids above 50 μm.

4 Human health hazards

PERACLEAN OCEAN is a preparat ion used for Ballast Water disinfection whose biocidal activity is based on peroxygen mechanism due main ly 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, harm ful by inhalation, if swallowed, and in contact with skin. Irritant to mucous memb ranes 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.MEPC 54/2/12 ANNEX 1 Page 57

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

Route of exposure LD 50 or LC50 Species Reference Oral (15% PAA) 1021 mg/kg bw Rat Degussa, 1982

Dermal (15% PAA) 1957 mg/kg bw Rabbit Kuhn, 1996

Inhalation, aerosol 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 di fficulties in generating a stable atmosphere and therefore accurate measurements of the test atmosphere and droplets of aerosol were difficult to achieve. In these circumstan ces, 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 rout e) and to mucous membranes either from the gastrointestinal tract (oral route) or the resp iratory tract (inhalation r oute). 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 caus ed by additional inhalation exposure.

It is considered that PAA due to its intrinsic physical-chemical properti es ñ log P<0, high water solubility and high hydroly sis 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 or gan toxicity, perhaps with excep tion of stomach ñ where pH is around 2 and PAA can be stable ñ nor bioaccumu late as the parent compound will rapidly be absorbed, distributed in the body fluid and meta bolized 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 te sts in guinea pigs with different formulations of PAA (5% and 12%). In one guinea pig maximisa tion test, a positive resu lt was claimed but the report does not permit critical evaluati on of the results (ECETOC JACC N 40, 2001).MEPC 54/2/12 ANNEX 1 Page 58

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I:\MEPC\54\2-12.doc 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 ësevere irritantí was determined.

Irritation to the respiratory tract An acute inhalation test was pe rformed by Janssen (1989) to inve stigate irritating properties of nebulised PAA 15%. The RD50 refe rring 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 cha nges 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 investigat e the toxic effects resulting fr om repeated dose administration.

Clinical and histopathological da ta 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 P AA will not be systematically available beyond the site of first contact.

According to the test conditi ons, a NO(A)EL (no observed advers e 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%. Applyi ng 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 defici encies 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 literat ure report effects arising from oral, dermal or inhalation exposure to PAA that seem to be related with local irri tation 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 ther efore no clear NAEL can be derived from available studies (ECETOC JACC, N40).

From the overall assessment of acute and sub-chr onic effects, it should be recommended that the irritation effects in the respiratory tract trig gered 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 occ upational exposure in non acci dental 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. Se veral bacterial tests were presented but due to cytotoxic effects at higher doses resulting from th e biocidal nature of PA A, these are of limited value for appraisal of these effects. However, as a general conclusion the Group can accept at this stage that PAA doesnít show a significant poten tial concern for mutagenicity/genotoxicity.MEPC 54/2/12 ANNEX 1 Page 59

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I:\MEPC\54\2-12.doc Chronic and long term toxicity, developmenta l and reproductive toxicity, carcinogenicity The applicant submitted a justification for non-submission of the following studies:

• sub-chronic toxicity stud y with a second species

• chronic toxicity study

• developmental and reproductive study

• carcinogenicity study

The argument presented in the ju stification for non-submission wa s the fact that by testing PAA was proven to be not systemically available a nd 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 re liable information avai lable concerning the testing of these endpoints (chronic or carcinogenicity studies , teratogenic and multigeneration studies), and doesnít 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 manufacturer sí procedures are followed. As the dosing is fully automated, no crew handling of the chemical is required. However, due to th e inherent dangerous properties of PERACLEAN OCEAN in its undilu ted 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 a nd oxidizing. Under the influence of heat or catalytically active substances it is liable to ra pid exothermic decomposition and decomposes into water, acetic acid, and oxygen. If i ngested 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 orga nic substances causing fire. It must not be brought into contact with combustible s, 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-standi ng firmly installed tanks of volume up to 50m 3 constructed of special grad e stainless steel, or in ex changeable containers, in a well ventilated independent compartment, de pending upon the space availability on deck or below deck. The storage room should be of fi reproof and seamless construction with an acid resistant floor. PERACLEAN OCEA N must not be confined in vessels, piping systems, or between valves. There must always be pressure release, such as a rupt ure disc, or breathing devices fitted to any volume that can be closed. For storage tanks a pressure release of at least 100 cm 2 per metric tonne is required. The storage temperature should not exceed 35 0 C. 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. C onnection 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 protecti on is required for this task and in accidental situations.

The requirement for a storage temperature below 35 0 C without the use of a temperature controlled atmosphere will preclude the use of th is product in some areas, particularly where tropical conditions may be encountered. Positi oning of storage space ve ntilation outlets willMEPC 54/2/12 ANNEX 1 Page 60

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I:\MEPC\54\2-12.doc require careful consideration to avoid risk to personnel should an y spillage or operation of the pressure release device occur. As compatibility of materials is essential, then the overboard emergency discharge arrangements will require particul ar 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 unlik ely to occur during the treatment operations, leakages will always be of concern and the rout ing of the supply pipe away from all sources of heat such as engine exhaust arrangements and steam piping w ill require care, particularly as the product decomposes at temperature greater than 60 0 C 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 engi ne 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 nor m. It will be necessary to provide venting arrangements for the supply piping or other breath ing devices to outside th e engine room to avoid potentially dangerous contaminations. Person al protective equipment including respiratory protection, hand protection, eye pr otection, acid proof clothing a nd 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 us e of positive pressure breathing apparatus and full chemical personal protection are not normally encountered on ships ot her than specialized chemical carriers. In consider ation of the risks that may be encountered in the use of this product, it may be appropriate to require additional training in th e 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 test s with diluted PERACLEAN OCEAN show no damage to standard epoxy tank coatings. It is recommended that the co rrosive effect is monitored for confirmation of this statement. As the substance is highly reactive with zinc, further confir mation that use of this product is permissible where the sh ips ballast system piping is inte rnally galvanised is necessary.MEPC 54/2/12 ANNEX 1 Page 61

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I:\MEPC\54\2-12.doc 6 Environmental fate and exposure

Fate and behaviour properties

Property PAA H 2 O 2 Acetic acid Hydrolysis pH4 DT50 = 48 h - pH7 DT50 = 48 h Variable but short -

pH9 DT50 = 3.6 h - Photolysis - - Degradation in seawater DT50 = 7ñ20 min DT20 = 25-35 min -

Ready biodegradation > 70% n.p. > 70% Biodegradation Rapid DT50 = 21h ñ 5d - Sorption Very low Very low Very low (e.j.) Bioconcentration No No No Anaerobic degradation - - -

Fate in ballast water tanks

The prescribed optimum dosage of PERACLEAN is an initial concentration in the ballast water at 150 mg PERACLEAN/L correspondi ng 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 wate r, a complete decay of perace tic acid was observed after 10-15 hours of exposure. Hydrogen per oxide degrades more slowly.

According to the available dossier, three diffe rent 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 peroxi de 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 H 2 O 2 concentrations after 24 hours were 1.4 ñ 2.5 mg/L depending on the initial concentrations (corresponding to approximately 92% degradatio n in 24 hours). The amount of H 2 O 2 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.MEPC 54/2/12 ANNEX 1 Page 62

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I:\MEPC\54\2-12.doc Fate in the environment

After discharge of ballast wa ter to the aquatic environmen t, hydrogen peroxide will undergo further degradation in the water phase. Based on the physicochemical properti es of the substance, no significant sorption to particul ate 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 degrada tion of active substance after discharge. There are no data documenting th e discharged concentration of active substances used in the model and the model is documented ne ither in the report nor in the dossiers. It is therefore difficult to control the calculate d PEC values used in the table below.

Discharged volumes are presented in docum ent MEPC 53/2/12 (approximately 390,000 ton/day). The total load of H 2 O 2 used in the MAMPEC model is given to be 30 kg H 2 O 2 /day from the ballast water. The concentration in the discharged ballast water can from this be calculated to be 0.077 mg H 2 O 2 /l.

Without more details about the i nput data to the model and a docum entation 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 fo r peracetic acid (PAA), hydrogen peroxide and the preparation PERAC LEAN 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/L 2 (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 NO EC = 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-Concentra tion 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.

2 The test data are difficult to interpret and the effect co ncentration may refer to a 5% PAA solution corresponding to a LC50 = 0.08 mg PAA/L.MEPC 54/2/12 ANNEX 1 Page 63

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I:\MEPC\54\2-12.doc 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 (H 2 O 2 ) as the most relevant substanc e contributing to the toxicity.

Hydrogen peroxide (H 2 O 2 ) Considering the toxicity criteria for identifica tion of PBT substances in Table 1 in the G9 Guidelines (Chronic NOEC < 0.01 mg/L) and th e EC50/NOEC data for the most sensitive organism presented in the submitted dossier (table below), it can be concluded that H 2 O 2 and thereby the PERACLEAN itself are not considered to be toxic.

H 2 O 2 toxicity values for the most sensitive organi sm (Source: DEGUSSA AG March 15, 2005, risk characterization In: Request for approval of PER ACLEAN OCEAN for ballast wa ter Treatment, Assessment report)

Taxonomic
group Species Endpoint Result Reference

Fish Pimephales promelas Mortality LC50 (96h): 16.4 mg/L EU 2003

Crustaceans Daphnia magna Immobilisation EC50 (24h): 2.3 mg/L EU 2003 Algae Skeletonema

costatum Growth inhibition EC50 (72h): 1.38 mg/L NOEC (72h): 0.63 mg/L EU 2003

- Chlorella vulgaris Growth inhibition EC50 (72h): 2.5 mg/L NOEC (72h): 0.1 mg/L EU 2003

Snail Physa sp. Mortality EC50 (96h): 17.7 mg/L EU 2003 Bivalve Dreissena polymorpha Mortality LC30 (56d): 5 mg/L NOEC: 2 mg/L EU 2003

- Mytilus galloprovincialis Mortality & development EC50 (48h): 1.58 mg/L NOEC (48h): 1.25 mg/L Dossier

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

8 Environmental risks

PBT assessment The following properties of the compone nts of PERACLEAN OCEAN are found:

Persistence Bioaccumulation Toxicity Peracetic acid Very quickly degradable Log Pow = -0.52 NOEC = 0.07 mg/L

Hydrogen peroxide Readily biodegra dable Log Pow = -1.5 NOEC = 0.1 mg/L Acetic acid

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 ba llast water, a test was conducted with a pH-adjusted sample.

The following results of the toxicity tests were obtained:MEPC 54/2/12 ANNEX 1 Page 64

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I:\MEPC\54\2-12.doc • Freshly treated sample, EC50 = 2.4%

• Treated sample (48 hours storage), EC50 = 18.6%

• Treated sample (48 hours storag e, pH adjusted), EC50 = 17.6%

Thus, the toxicity of the ball ast 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 corre sponds 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 test ed 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 peroxi de to aquatic species into account the Group considered that some acute impact may be ex pected 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 occurri ng in the receiving environment.

The environmental risk of the estimated and measured concentr ations of hydrogen peroxide in treated ballast water has been assessed as well. The application report concludes that the calculated PEC of H 2 O 2 is lower than PNEC as presented in the table below.

The Group calculated also PEC/PNEC ratio considering th e toxicity data for the most sensitive organism (see table below) and other information from the dossier. The H 2 O 2 PNEC in water proposed by the EU (in EU, 2003, Hydrogen Peroxi de, Summary Risk Assessment Report) is 10

μ g/L. In the calculations the Group used both cons ervative and non-conserva tive 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 H 2 O 2 discharged Source PEC (μg/l) NOEC (μg/l) Assessment factor PNEC(μg/l) PEC/PNEC

MEPC 53/2/12 (worst case scenario with H 2 O 2 degradation) 4.9 100 10 10 0.49

MEPC 53/2/12 (worst case scenario without H 2 O 2 degradation) 9.9 100 10 10 0.99

If we accept the PEC values calculated with th e MAMPEC model, the Gr oup can conclude that for the long term the risk of discharge will be acceptable even for th e 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 su fficiently justified in the dossier.MEPC 54/2/12 ANNEX 1 Page 65

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I:\MEPC\54\2-12.doc 9 Conclusions and recommendations

Upon application of PERACLEAN OCEAN in balla st water, the PAA is degraded almost completely after less than 24 hours. Hydrogen peroxide, however, de grades more slowly with the degradation rate depending on the content of organic matter and particles in the ballast water. Applying the recommended dosi ng of 150 mg/L PERACLEAN OCEA N, a typical concentration of hydrogen peroxide at 2 mg/L ma y be expected in the discharged ballast water. In cases where ballast water has a low content of organic matte r and particles, and where the holding time is short (48 hours or less), concentr ations of up to 15 mg/L of hydr ogen peroxide may be expected.

Aquatic toxicity testing with treated ballast wate r shows that the acute t oxicity encountered can be ascribed mainly to the content of hydrogen per oxide. It is further note d that even with the lowest concentration of hydrogen pe roxide in the treated ballast wa ter (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 μg/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 mode l are not presented in de tail, which hinders the evaluation of the reliability of the model results . It appears from the dossier that resulting concentrations in the aquatic e nvironment after discha rge and dilution are at the maximum of 5- 10 μg/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 PERACLEA N 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 ac ute adverse effects (corrosiveness, severe irritant for skin and eye, irritant for the respiratory tract). In this sense, we recommend as mandatory the applic ation 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 a nd RPE) must be put in place for use and handling of the preparation at the different stages of the pr ocess and with the different concentrations applied.

• Additionally, it is recommended that dermal and inhalation sub-chronic effects in presented studies should be further investigat ed, taking into account realistic occupational exposure scenarios and covering non-accident s ituations. These data should be submitted before final approval.

• There seems to be insufficient information on degradation of components of PERACLEAN OCEAN during treatme nt of ballast water as it seems to depend on the content of organics and partic les in ballast water. This should be further studied andMEPC 54/2/12 ANNEX 1 Page 66

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I:\MEPC\54\2-12.doc reliable estimates or measurements of con centrations 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 justif ication. This would include propos als for numbers of ships in the harbour, the volume of treated ba llast water, the frequency and duration of discharges, the dimensions of the harbour including water volu me and flow. The Group notes that this is not necessarily an obligation of the individual applican t, but that this mi ght be considered at a general level (cf. the re port of the BWWG 1 meeting).

• Based on the updated information, a revised envi ronmental risk assessment needs to be submitted for a final approval.

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

* * *MEPC 54/2/12 ANNEX 1 Page 67

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I:\MEPC\54\2-12.doc ANNEX 6

REVIEW OF PROPOSALS FOR APPRO VAL OF ACTIVE SUBSTANCES - SUBMITTED BY RE PUBLIC OF KOREA (ELECTROCLEAN)

ELECTRO CLEAN evaluation report

The basis for the Working Groupís evaluation of ELECTRO CLEAN system (ECS) was the application dossier submitted by the Republic of Ko rea. Further data sources were found in the IUCLID data base hosted by the European Commissionís 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 assessme nt to the environment.

• Information on the reliability and accuracy of the control scheme.

• The dossiers do not provide any data on the co rrosivity of the treated ballast water.

• Data on human exposure to the active substanc es not allowing risk evaluation of use and handling

• Justification of non submission of data

• Calculation of the predicted environmental concentration (P EC) 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 acce ss to the input data does not produce any valuable data. The calculated PEC values are therefore only used as indicative estimates in this assessment.

2 Identity

Physicochemical properties Property Cl 2 HO

⋅ HOCl Molecular weight 70.906 17 52 Physical state Gas NA liquid Melting point [  ̊ C] -101 NA -6 Boiling point [  ̊ C] -35 NA 40 (d) (Relative) density [kg/m 3 ] 3.214 [g/m 3 ] NA 1.1 Vapour pressure [Pa] 6.8 10 5 NA NA Solubility [g/L] 14.6 NA Miscible Log Kow NA -3.42 pKa NA Viscosity [cP] NA 0.01327 Henryís law constant [-] NA Flash point [  ̊ C] NA Auto ignition temperature [  ̊ C] NA

Flammability NA Explosive properties NA NA = not applicable (d) = decomposition at indicated temperatureMEPC 54/2/12 ANNEX 1 Page 68

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I:\MEPC\54\2-12.doc 3 Application The submission informs of Electro-Clean te chnology which disinfects ballast water by electrolysis. Disinfection is carried out direct ly 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 chemical s are required to be stored on board as the active substances are pr oduced 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 concentratio ns of active substances are controlled by applied current density to the flow cell of the electrolys is cell. And the volume di rectly influences the TRC concentration at discharge and environmenta l risks. In the background documents, planned to set the ìsensorî at the exit point of the system before ballast tank and monitors the value, which is used for the control pa rameter of the systems. But th ere is no description about the sensor; directly measuring TRC, or so me 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 Cl 2 , HOCl, OCl

ñ , and OH radicals are produced electrolytically in situ and presumably have a very short-life.

The biocidal efficacy of the formulation is consider ed to be a result of it s 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 concentr ations of the di fferent compounds involved in the disinfection pro cess 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 Human health endpoints Hypochlorite Chlorine Hydroxyl radicals

Acute toxic effects Oral Irritation, pain, inflammation of mucoses. In severe cases causes ulceration and perforation of gastro inte stinal tract. Health effects depend on several factors: amount, concentration and pH of the solution Irritant effects 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, extremeexcitability. A shortterm mechanism is theMEPC 54/2/12 ANNEX 1 Page 69

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I:\MEPC\54\2-12.doc Main compounds in the equilibrium solution Human health endpoints Hypochlorite Chlorine Hydroxyl radicals

respirationcompensation. A longterm mechanism is the renal compensation. Dermal Mild irritation to corrosive injury depending on the concentration Irritant effects

Inhalation 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 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

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 Acute inflammatory effects

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 Acute inflammation effects towards cornea and conjunctiva

Irritation to the respiratory tract Hypochlorite does not easily form vapours however in more concentrated solutions and at high pH, mists that Acute effectsMEPC 54/2/12 ANNEX 1 Page 70

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I:\MEPC\54\2-12.doc Main compounds in the equilibrium solution Human health endpoints Hypochlorite Chlorine Hydroxyl radicals

form can cause mild to severe irritation of the nose and throat Repeated Dose Toxicity (90 d) Not available Not available Not available

Toxicokinetics It was shown that hypochlorite does not accumulate in the body, it reacts with tissues and apparently is readily absorbed in serum and eliminated from plasma with half-life of 44 h. Chronic and long term toxicity health effects From the applicants report it was not possible to conclude if the substance is an occupational skin sensitizer; however some sporadic cases are reported. 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 Has not been suggested as mutagenic according to available information. However, some effects concerning sperm shape have been recorded Developmental and reproductive toxicity No specific conclusions about the potential for developmental toxicity in a chlorinated drinking water study. There is insufficient information to draw conclusions. However, some indicative effects of altered sperm shape have been detected Chlorine was considered teratogenic in experimental animals

Carcinogenicity It is not classified by IARC. In most studies there is a lack of statistical evaluation of the results and lack of dose-response relationship Lymphoma has been observed in relation to water treatment with chlorine. Associations with increased renal, bladder and gastric cancers have been registeredMEPC 54/2/12 ANNEX 1 Page 71

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I:\MEPC\54\2-12.doc From the above information it is concluded that the main health effects are acute in nature; however some concerns are addressed relate d to the reproductive system under long term exposure scenarios.

5 Risks to safety of ship and crew The submission states that the application of El ectro-Clean technology is safe to the ship and crew during operation as the level of active subs tances produced is be low recognised standards for dangerous substances, and that the active s ubstances generated remain within the closed ballast water system.

The dossier presented refers to tests with simula ted ballast water indicating that Trihalomethane (THM) discharges remain within acceptable limits. The residua l chlorine levels immediately following treatment are given as being in the range of 10ñ30 parts per million. Other studies have suggested that THM is formed from the br eakdown of chlorine and organic matter and that THM generation increases with pH, time, temperat ure 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 ve ntilate 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 ga s 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 a nd 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 to gether with increased co rrosion. This may be especially relevant for ballast piping after the tr eatment unit as additional turbidity caused by gas generation may be anticipated.

No data of the corrosivity of treated ballast wa ter was provided in the dossier. However, other reports available for the Group i ndicate an increase of approx imately 100% of normal corrosion rates in the lower sections of ballast tanks. The in itial concentration of TRC in these studies were reported to be around 5 mg TRC/L, while the initial studies in the ECS is gi ven to be between 20 and 30 mg TRC/L. The applicant th erefore should provide corrosion studies going over at least six months.MEPC 54/2/12 ANNEX 1 Page 72

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I:\MEPC\54\2-12.doc 6 Environmental fate and exposure

6.1 Fate and behaviour properties

Property Cl 2 HO

⋅ HOCl Hydrolysis pH4 Dissociation NA Unstable pH7 Dissociation NA Unstable pH9 Dissociation NA Unstable Photolysis Very quick NA Very quick Degradation in seawater Dissociation NA Unstable Ready biodegradation NA NA NA Biodegradation NA NA NA Sorption NA NA NA Bioconcentration NA NA NA Anaerobic degradation NA NA NA

NA = not applicable

6.2 Fate in ballast water tanks

Considerations:

• As stated in the application dossier the fo rmation of the Active S ubstance is described with the following reaction equations: Cl 2 + H 2 O HCl + HOCl HOCl H + + OCl

ñ where HOCl and OCl

ñ are considered the real actives.

• The amount of chloride ions pres ent in seawater is about 19.5 g Cl

ñ /L.

• In seawater also bromine is a natu ral constituent amounting about 0.068 mg Br

ñ

/L.

• At normal pH-values in seawater OCl

ñ 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 H 2 O and CO 2

.

• In the literature it is known that am ongst these oxidation products also trihalomethanes, halophenols, and ch lorinated 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 leve ls than the detection limits of the chemicals of concern. Concentrati ons determined stayed generally well below the limit of detection.

Some experiments determined the half life of tota l residual chlorine (TRC). TRC is defined as the amount of chlorine still active. It was found th at there is a significan t 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 und er light conditions. Levels up to 30% of initialMEPC 54/2/12 ANNEX 1 Page 73

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I:\MEPC\54\2-12.doc concentration and in one case up to about 60% of th e 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). Suchlevels 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 turbidit y of the receiving waters will limit the decay.

6.4 PEC calculation The document MEPC 54/2/3 in item 5.4 presents info rmation 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 consider ed that the total resi dual chlorine (TRC) at discharge, proposed in Doc. ME PC54/2/3, 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 sc enario using the same d ilution 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:

• Cl 2 (Chlorine)

• HOCl (Hydrogen hypochlorite)

• OCl

ñ (hypochlorite ion)

• OH· (hydroxyl free radicals)

Remarks:

• High concentrations (20 ñ 30 mg/L) of the above mentioned activ e substances will quickly react with other substances in the se awater and the active substances will be an equilibrium mixture of hypochlorous acid (HOCl), hypochlorite ions (OCl

ñ ), hypobromous acid (HOBr), hypobromite ions (OBr

ñ ) and others. These are often referred to as chlorine produced oxidants (CPO) in s eawater 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 th e dossiers. By the presence of bromide in sea water during the electrolytic process, bromine and consequently hypobromous acid and hypobromite will be also produced an d no consideration wa s given about these actives substances in this assessment.

• There is little information about the activ e substances formed when electrolysing freshwater.

7.2 Aquatic toxicity data Remarks:

1. In the dossiers some data have been indi cated as chronic. According to the Group these should be considered as acute toxicity data.MEPC 54/2/12 ANNEX 1 Page 74

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I:\MEPC\54\2-12.doc 2. The test data claimed to present acute toxicity with 30 and 60 minutes exposure. They should be considered as not releva nt for assessing environmental hazards and they are therefore not used in this assessment. 3. Short term and long-term a quatic 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 Keratella cochearis Mortality 4 h TL50: 0.019 mg/l Fresh Water Fish Salmo gardnerii Mortality 168 h LC50 = 0.08 mg/l

Hypochlorite ion/Hydrogen hypochlorite Aquatic toxicity data of hypochl orite with key species are pr esented in the table below: Taxonomic

group Species Endpoint Result Reference

Algae Thalassiosira guilardii Growth inhibition EC50 (24h): 0.075 mg/L IUCLID

Crustaceans Ceriodaphnia sp. Mortality LC50 (24h): 0.006 mg/L IUCLID

Fish Clupea harengus Mortality LC50 (96h): 0.033-0.097 mg/L IUCLID

Oncorhyncus gorbuscha Mortality LC50 (96h): 0.023-0.052 mg/L IUCLID

• 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 wi ll 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 contai ned in this assessment.MEPC 54/2/12 ANNEX 1 Page 75

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I:\MEPC\54\2-12.doc 8 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 μ g/L Free hydroxyl radical Very quickly degradable

None of the substances identified in the ap plication dossier as be ing generated in the electrolytical process fulfil the criteria for PB T substances. Other substances that might be generated during and after the process may posse ss PBT properties, but it has not been possible to consider this in th e current evaluation due to lack of information.

8.2 Toxicity of treated water when discharged Remarks :

• Some of the data provided in the three do ssiers 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 part icular the case for the decay rates presented for TRC where several studies indicate that TRC ma y be higher than 8 mg/L after 1 ñ 2 days (or more), while the a pplication states (MEPC 54/2/3 p. 21) that the TRC in the discharge will be ìless than a few mg/Lî 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 toxici ty may be high when tr eated ballast water is discharged.

• In the dossiers and MEPC 54/2/3 there are severa l references to permitted effluent limits of TRC. According to USEPA 1999 the CMC (Criteria Maximum Concentration) is 13

μ g/L of chlorine (as free chlori ne). This value is also used as limit for CPO in effluent water to enclosed bays and estuaries in the 2005 Draft from Ca lifornia Environmental Protection Agency (1 hour average con centration), the 4 da y maximum average concentration is given to be 7.5 μ g/L.

• Dilution calculations are copied from the German application and contain even less background information about the basic assump tions 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 te sted in a dilution series presented in pages 80-81 in Technical Add Documents (Book 3). There wa s no information about the concentration of TRC in the tested water. Dilutions of the tr eated 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 ñ 2%

- Ciliates: 5 ñ 10 %

- Copepods (Acartia): 40 %

- Fish: 10 ñ 20%MEPC 54/2/12 ANNEX 1 Page 76

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I:\MEPC\54\2-12.doc 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/PN EC ratio was considered. The NOEC from chronic toxicity results availa ble for hypochlorite for daphnia provi ded from the dossier was used and it was also assumed that the TRC was refe rred to hypochlorite. The PEC/PNEC for the TRC of 5 mg/l was calculated for daphni a. [I donít understand this sent ence? In my view, it could go out.] The lowest acute toxicity data availabl e for other organisms was used. The table below presents the values of PEC/PNEC.

PEC/PNEC for NaOCl discharged Source PEC (μg/l) NOEC (μg/l) Assessment factor PNEC(μg/l) PEC/PNEC

10 3.1 4.52 Dossier & Doc.

MEPC 54/2/3 14 31 100 0.31 45.2

10 8.7 1.61 Dossier & Doc.

MEPC 54/2/3 14 87 100 0.87 16.1

10 3.1 0.75 Calculated 2.33 31 100 0.31 7.52 10 0.6 3.8 Calculated 2.33 6 100 0.06 38

In general, the PEC/PNEC is higher than 1 for th e 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 pr oduce 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 respirator y tract) therefore recommended as mandatory the application RMM (r isk 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 scie ntific knowledge, the adverse health effects associated to chlorinated by-products exposure should be furt her 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.MEPC 54/2/12 ANNEX 1 Page 77

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I:\MEPC\54\2-12.doc 9.4 It seems that the applicati on 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 ba llast water that largely exceed limit values established for discharge of waste wa ter from land-based point sources. The degradation rate of TRC is so low that s ubstantial 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 c onducted with sea water to different species immediately after treatment w ith 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 conc entrations 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 assumi ng a dilution of approximately 2,000 times and derived Predicted No-Effect-Concentr ations for hypochl orite 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 doc umentation of the quality control/quality assurance programme as requested in G9: 4.2.4.

9.5 After considering all of the above concer ns, it is the opinion of the Group that the proposal has not demonstrated whet her there is a potential for unr easonable risk for environment, human health, property and resources. The Group th erefore considers it appropriate that further land-based studies be conducted before on board testing eventually takes place. Consequently, the Group recommends that the Organization s hould grant a basic appr oval to the proposed Electro Clean System with conditi ons that land-based te sting address the concerns for short- and long-term impacts to the receiving waters befo re an eventual on-board testing is approved.

***MEPC 54/2/12

I:\MEPC\54\2-12.doc 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 Time allocation Activities to be undertaken by the Secretariat 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 ∗ 8 weeks • 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 20 weeks n/a 1 week • facilitate the meeting of the GESAMP-BWWG 19 weeks n/a 1 week • assist consultant to finalise the report and circulate the final draft to GESAMP 18 weeks • Confirm their acceptance for the distribution of the report after checking that no confidential data is contained 4 weeks • coordinate GESAMP review and approval of the report

14 weeks n/a 1 week • consolidate the final report and prepare the submission to MEPC 13 weeks n/a 13 weeks • Documents Section processes, translates and distributes the report as an MEPC document week of

MEPC n/a 1 week • Committee takes into account the report of the GESAMP-BWWG when deciding on Basic Approval

_____________

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