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.
8.1.2 Procedure to be followed:
.1 The manufacturer should evaluate the Active Substances or Preparations and the potential discharge in accordance with the approval criteria specified in this procedure.
.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.
.3 The Administration having received a satisfactory application should as soon as possible propose an approval to the Organization.
.4 Members of the Organization may propose an approval.
.5 The Organization should announce and set the time frame for the evaluation of Active Substances and Preparations.
.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.
.7 The Organization should establish a Technical Group in accordance with its rules of procedure ensuring that proprietary data should be treated as confidential.
.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.
.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.
.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.
.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.
.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 Organization8. An Active Substance or Preparation may be used for Prototype or Type Approval testing for the approval of different BWMS without going through basic approval again.
8 Guidelines for approval of prototype ballast water treatment technologies and Guidelines for approval of Ballast Water Management Systems.
8.2. In accordance with Regulation D-3.2, a Ballast Water Management system using an Active Substance or Preparation to comply with the Convention (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 Approval tests in accordance with Guidelines for Approval of Ballast Water Management Systems. The results should be conveyed to the 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 with Regulation D-3.2. Active Substances or Preparations that have received Basic Approval by the Organization may be used for evaluation of Ballast Water Management systems using Active Substances or Preparations for Final Approval.
8.3 Notification of approval
8.3.1 The Organization will record the Basic and Final Approval of Active Substances and Preparations and Ballast Water Management systems 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.
8.4.1 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 Member of the Organization. The Member of the Organization should inform the Organization accordingly.
8.4.2 Manufacturers intending to significantly change any part of a Ballast Water Management System that has been approved by the Organization or the Active Substances and Preparations used in it should submit a new application.
8.5 Withdrawal of approval
8.5.1 The Organization may withdraw any approval in the following circumstances:
.1 If the Active Substances and Preparations or Ballast Water Management system that make use of Active Substances no longer conforms to requirements due to amendments of the Convention.
.2 If any data or test records differ materially from data relied upon at the time of approval and are deemed not to satisfy the approval condition.
.3 If a request for withdrawal of approval is made by the Member of the Organization on behalf of the manufacturer.
.4 If unreasonable harm to environment, human health, property or resources is demonstrated by any Member of the Organization or observer to have been caused by the approved Ballast Water Management system that make use of Active Substances or Preparations.
Approval Scheme for Active Substance or Preparation and Ballast Water Management systems that make use of Active Substances
1. BASIC APPROVAL
2. FINAL APPROVAL