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8 APPROVAL
8.1 Approval Procedure
8.1.1 The manufacturer, who intends to obtain approval of the active substances product should prepare an application and submit it to an Administration.
8.1.2 The Party to the Convention will then submit the Application Form and Data on active substances products in the form set out at Appendix 1 to the Organization.
8.1.3 All proprietary data will be treated as confidential by the Organization and its Technical Group, the Competent Authorities involved, and the evaluating regulatory scientists, if any.
8.1.4 Procedural steps to be performed (time schedule to be developed):
.1 The manufacturer should evaluate the Active Substance or preparation and the potential effluent in accordance with the approval criteria specified in chapter [・・・].
.2 Upon completion, the manufacturer should prepare an Application Form with Data on the Active Substances Product in the form set out at Appendix I and submit it to the Administration concerned as specified in paragraph [・・・].
.3 Any Party to the Convention may submit data and propose an approval. A proposal containing the information in the form set out at Appendix 1 shall be submitted to the Organization.
.4 The Organization shall establish a Technical Group in accordance with its rules of procedure ensuring that proprietary data will be treated as confidential.
.5 The Technical Group shall 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 ship safety, the environment or human health. [In any case the Active Substance or preparation and its effluent shall meet the criteria listed in chapter 6.]
.6 The Technical Group's report shall 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.
.7 The competent Committee of the Organization shall decide whether to approve any proposal, introduce any modifications thereto, if appropriate, taking into account the technical group's report. Only Parties to the Convention may participate in decisions taken by the Committee.
.8 The Administration will inform the applicant about the approval of the active Substance or preparation and their approved manner of application by the Organization. The certificate provided by the Administration allows immediate application of the approved product.
8.2 Notification of Approval
8.2.1 The Organization will record the approval of active substances product in report of the relevant IMO meeting and circulate the list of approved Active Substances Products once a year listing:
Name of Active Substances Product;
Date of approval;
Expiry date of approval;
Name of manufacturer; and
Any other specifications, if necessary.
6.2.2 Any Administration should report to the Organization when the Administration approved any Ballast Water Management Systems (according to guideline [...]) which make use of approved Active Substances Product.
8.3 Term of Validity
8.3.1 The term of validity of the approval of active substances product will be ten years from the date of approval.
8.4 Renewal of Approval
8.4.1 Manufacturer, who intends to obtain renewal of approval of the active substance product shall prepare an Application Form and Data according Appendix I and submit them to the Administration involved in accordance with paragraph [...]. The Organization shall then proceed in accordance with paragraph [・・・].
8.5 Modification
8.5.1 Manufacturer should report any minor modifications in names, composition or use of the Active Substances product which has been approved by the Organization, to the Administration. The Administration should inform the Organization accordingly.
8.5.2 Manufacturer, who intends to significantly modify the Active Substances product which has been approved by the Organization, should prepare an Application Form and Data on Active Substances products according to paragraph [...]. The Administration and the Organization should proceed accordingly.
8.6 Withdrawal of approval
8.6.1 The Organization may withdraw the approval of an Active Substance, or preparation:
.1 if the Active Substances Product no longer conforms to the actual requirements due to amendments or implementation to the Convention.
.2 if any data or test records differ remarkably from data 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 Administration on behalf of the manufacturer.
.4 if unreasonable harm to safety, human health or the aquatic environment has been shown to be caused by the approved Active Substance or preparation.
Appendix 1
1. APPLICATION FORM FOR APPROVAL*/RENEWAL OF APPROVAL*
2. /PARTIAL MODIFICATION*//WITHDRAW OF APPROVAL*
3. OF ACTIVE SUBSTANCES PRODUCT
4. MANUFACTURER NAME:
5. PRODUCT NAME:
6. MAXIMUM ACTIVE SUBSTANCE PRODUCT CONCENTRATION:
7. TIME ELAPSED FROM TREATMENT TO DISCHARGE:
8. APPROVED ON (IF APPROVED):
9. THE NATIONAL ADMINISTRATION INVOLVED:
10. ATTACHMENT LIST:
11. REPORTING FORM FOR THE SUBMISSION OF DATA FOR THE EVALUATION OF ACTIVE SUBSTANCES
12. DATE OF APPLICATION:
13. MANUFACTURER ADDRESS:
14. TELEPHONE AND FAX NUMBER:
15. NAME OF CONTACT PERSON:
(A detailed format to be added at a later stage based on a reduced version of the revised IMO format "Characteristics of chemicals proposed for marine transport in bulk").
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