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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-MY-105628-4   |   PDF   |   Print   |  
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published: 24 Jun 2014 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
Risk assessment details
  • MOUSTICIDE™
    | EntoGenex Industries Sdn. Bhd. | 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
EN
Please refer to the Risk Assessment Report
EN
Please refer to the Risk Assessment Report
EN
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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Country's Decision or any other Communication Risk assessment 1