8.1.1 All proprietary data should be treated as
confidential by the Organization and its Technical Group, the Competent
Authorities involved, and the evaluating regulatory scientists, if
any. However, all information related to safety and environmental
protection, including physical/chemical properties, environmental
fate and toxicity, should be treated as non-confidential.
8.1.2 Procedure to be followed:
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.1 The manufacturer should evaluate the Active
Substances or Preparations and the potential discharge in accordance
with the approval criteria specified in this procedure.
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.2 Upon completion, the manufacturer should prepare
an Application on the Active Substances and Preparations and submit
it to the Member of the Organization concerned. An application should
only be made once the ballast water management system, Active Substance
or Preparation has been sufficiently designed, progressed and tested
to provide the full data necessary for a Basic Approval.
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.3 The Administration having received a satisfactory
application should as soon as possible propose an approval to the
Organization.
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.4 Members of the Organization may propose an
approval.
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.5 The Organization should announce and set the
time frame for the evaluation of Active Substances and Preparations.
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.6 Parties, Members of the Organization, the United
Nations and its Specialized Agencies, intergovernmental organizations
having agreements with the Organization and non-governmental organizations
in consultative status with the Organization may submit information
that is relevant to the evaluation.
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.7 The Organization should establish a Technical
Group in accordance with its rules of procedure ensuring that proprietary
data should be treated as confidential.
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.8 The Technical Group should review the comprehensive
proposal along with any additional data submitted and report to the
Organization whether the proposal has demonstrated a potential for
unreasonable risk for environment, human health, property or resources
in accordance with the criteria specified in this procedure.
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.9 The Technical Group's report should be in written
form and circulated to the Parties, Members of the Organization, the
United Nations and its Specialized Agencies, intergovernmental organizations
having agreements with the Organization and non-governmental organizations
in consultative status with the Organization, prior to its consideration
by the competent Committee.
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.10 The Committee of the Organization should decide
whether to approve any proposal, introduce any modifications thereto,
if appropriate, taking into account the Technical Group's report.
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.11 The Member of the Organization that submitted
the application to the Organization should inform in writing the applicant
about the decision made with regard to the respective Active Substance
or Preparation and their manner of application.
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.12 Active Substances or Preparations receiving
Basic Approval by the Organization may be used for prototype or type
approval testing based on the guidelines developed by the Organizationfootnote. 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 BWMS.
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.13 An applicant seeking to take advantage of
an Active Substance or Preparation's Basic Approval should provide
in its application a written agreement from the applicant whose Active
Substance or Preparation has been granted the initial Basic Approval.