Malaysia | BCH-RA-MY-105628 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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Risk Assessment generated by a regulatory process (RA)

last updated: 17 May 2022
General information
Risk Assessment Report of the GMAC for an Approval to Release Products of TMOF yeast
EN
19 Apr 2011
  • - Competent National Authority: BCH-CNA-MY-48230-13 | BCH-CNA-MY-48230-13
    Competent National Authority
    Department of Biosafety Malaysia ()
    Ministry of Environment and Water Level 4, Block F11, Complex F Lebuh Perdana Timur, Precinct 1
    Putrajaya,
    62000, Malaysia
    Phone: +603 80917 317,
    Fax: +603-8091 7371,
  • - Person: Dr. Norwati Adnan | BCH-CON-MY-254013-4
    Person
    Dr. Norwati Adnan
    Director, Department of Biosafety
    Department of Biosafety, Ministry of Environment and Water Ministry of Environment and Water, Level 4, Block F11, Complex F, Lebuh Perdana Timur, Precinct 1
    Putrajaya, Putrajaya
    62000, Malaysia
    Phone: +603 - 80917 319,
    Fax:
Risk assessment details
  • MOUSTICIDE™
    | Mr Mohd Alhafis Rusdi Changes in quality and/or metabolite content - Protein and amino acids
Methodology and points to consider
Please refer to the Risk Assessment Report
EN
Please refer to the Risk Assessment Report
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Please refer to the Risk Assessment Report
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Please refer to the Risk Assessment Report
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GMAC has conducted a thorough evaluation of the application for the release activities of TMOF _Yeast (Technical Grade Active Ingredient, TGAI) product and has determined that the release of this product in limited amount does not endanger biological diversity or human, animal and plant health (as per the amounts currently with the MOH). This applies to the use of Mousticide WP and Mousticide RH (produced from CEPP, UTM). However, assessment should be done again if the TMOF contains a different formulation other than the Mousticide WP and Mousticide RH as well as if these products (Mousticide WP and Mousticide RH) are produced again in another facility as there may be variables in the effectiveness of the protocols used as well as variations in the risk exposure pathways. GMAC recommends that the proposed application for release be APPROVED WITH TERMS AND CONDITIONS as listed in section IV - Proposed Terms and Conditions for Certificate of Approval. GMAC also recommends that section VI – “Identification of Issues to be addressed for subsequent release of this product” be communicated at the same time to the applicant. 
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Information sharing with other databases
Yes
Yes
No
Additional Information
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Records referencing this document Show in search
Record type Field Record(s)
Country's Decision or any other Communication Risk assessment 1