1.1 The "Procedure for approval of ballast water
management systems that make use of Active Substances (G9)" (Procedure
(G9)) provides that, subject to evaluation against the criteria
developed by the Organization, an Active Substance or Preparation
may be used for Prototype or Type Approval testing for the approval
of different ballast water management systems (BWMS).
1.2 The objective of this document is to provide
guidance for the manufacturers and the Administration, and for other
interested parties, in preparing an application based on the use of
an original Basic Approval and, for its subsequent evaluation by the
GESAMP-BWWG for Final Approval according to Procedure (G9).
1.3 An Active Substance or Preparation should
be identical to the Active Substance or Preparation that has already
received Basic Approval and its treatment concentration should be
less than or equal to the original Basic Approval. In addition, any
recommendations by the MEPC for the Basic Approval, including neutralization
and maximum allowable discharge concentration (MADC) considerations,
should be applied.
1.4 The document provides a framework including
criteria to enable direct comparison of the physical nature of the
system, the chemical nature of the Active Substance or Preparation,
and the legal and commercially sensitive nature of the information
and data being transferred.
1.5 When considering an application, the use of
an Active Substance or Preparation should be substantially similar
to the original application that has gained Basic Approval, as this
needs to be considered in the context of the BWMS within which it
is used. This is because of the way different systems use the Active
Substance or Preparation, that may change the nature of the Active
Substance or Preparation itself. For example, hydrogen peroxide can
be used as a chemical treatment on its own or as a catalyst in combination
with a secondary method.
1.6 Any BWMS that has been granted approval to
use a Basic Approval from another system is still subject to the Final
Approval process, as set out in Procedure (G9).
1.7 Any BWMS seeking to use the Basic Approval
from another system should also meet conditions or requirements placed
on the original Basic Approval by the Committee.
1.8 Before considering the development of an application
to use a Basic Approval from another system, an applicant should consider
that the less similarity between the two systems, the more data that
will need to be supplied to evaluate the application.