The proposal for approval of an Active Substance or a Preparation should include a
chemical identification and description of the chemical components even if generated onboard.
A chemical identification should be provided for any Relevant Chemicals.
4.2 Data-set for Active Substances and Preparations4.2.1
A proposal for approval should include information on the properties or actions of the
Preparation including any of its components as follows:
Data on effects on aquatic plants, invertebrates, fish, and other biota, including
sensitive and representative organisms:
• acute aquatic toxicity;
• chronic aquatic toxicity;
• endocrine disruption;
• sediment toxicity;
• bioavailability/biomagnification/bioconcentration; and
• food web/population effects.
Data on mammalian toxicity:
• acute toxicity;
• effects on skin and eye;
• chronic and long-term toxicity;
• developmental and reproductive toxicity;
• carcinogenicity; and
Data on environmental fate and effect under aerobic and anaerobic conditions:
• modes of degradation (biotic; abiotic);
• bioaccumulation, partition coefficient, octanol/water coefficient;
• persistence and identification of the main metabolites in the relevant media
(ballast water, marine and fresh waters);
• reaction with organic matter;
• potential physical effects on wildlife & benthic habitats;
• potential residues in seafood; and
• any known interactive effects.
Physical and chemical properties for the Active Substances and Preparations and
the treated ballast water, if applicable:
• melting point;
• boiling point;
• density (relative density);
• vapour pressure, vapour density;
• water solubility / dissociation constant (pKa);
• oxidation/reduction potential;
• corrosivity to the materials or equipment of normal ship construction;
• autoignition temperature; and
• other known relevant physical or chemical hazards.
Analytical methods at environmentally relevant concentrations.
A proposal for approval should include the above data set either for the Preparation or for
each component separately, and a list of the name and relative quantities (in volumetric
percentages) of the components should be also attached. As described in section 8.1, all
proprietary data should be treated as confidential.
The tests for Active Substances and Preparations should be carried out in accordance with
internationally recognized guidelines5
5 Preferably Organization for Economic Cooperation and Development (OECD) Guidelines for Testing of
Chemicals (1993) or other equivalent tests. 4.2.4
The testing process should contain a rigorous quality control/quality assurance
programme consisting of:
Both a Quality Management Plan (QMP) and a Quality Assurance Project Plan
(QAPP). Guidance on preparation of these plans, along with other guidance
documents and other general quality control information are available for
download from the International Organization for Standardization (ISO)
The QMP addresses the quality control management structure and policies of the
Test Organization (including subcontractors and outside laboratories).
The QAPP is a project specific technical document reflecting the specifics of the
system to be tested, the test facility, and other conditions affecting the actual
design and implementation of the required experiments.
Dossiers already used for registration of chemicals can be submitted by the applicant to
satisfy the required data needed for the evaluation of Active Substances and Preparations
according to this procedure.
The proposal should describe the manner of application of the Preparation for Ballast
Water Management, including required dosage and retention time.
A proposal for approval should include (Material) Safety Data Sheets ((M)SDS).
4.3 Assessment report4.3.1
A proposal for approval should include an assessment report. The assessment report
should address the quality of the test reports, the risk characterization and a consideration of the
uncertainty associated with the assessment.