4.2.1 A proposal for approval should include information
on the properties or actions of the Preparation including any of its
components as follows:
-
.1 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.
-
.2 Data on mammalian toxicity:
- acute toxicity;
- effects on skin and eye;
- chronic and long-term toxicity;
- developmental and reproductive toxicity;
- carcinogenicity; and
- mutagenicity.
-
.3 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.
-
.4 Physical and chemical properties for the Active
Substances and Preparations and the treated ballast water, if applicable:
- melting point;
- boiling point;
- flammability;
- 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.
-
.5 Analytical methods at environmentally relevant
concentrations.
4.2.2 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.
4.2.3 The tests for Active Substances and Preparations
should be carried out in accordance with internationally recognized
guidelinesfootnote.
4.2.4 The testing process should contain a rigorous
quality control/quality assurance programme consisting of:
-
.1 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) (www.iso.org).
-
.2 The QMP addresses the quality control management
structure and policies of the Test Organization (including subcontractors
and outside laboratories).
-
.3 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.
4.2.5 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.
4.2.6 The proposal should describe the manner
of application of the Preparation for ballast water management, including
required dosage and retention time.
4.2.7 A proposal for approval should include (Material)
Safety Data Sheets ((M)SDS).