Malaysia | BCH-RA-MY-105097 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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Risk Assessment generated by a regulatory process (RA)

last updated: 13 May 2022
General information
Risk Assessment Report of the Genetic Modification Advisory Committee (GMAC) for an Application for Approval for Release of Product of Imidazolinone-Tolerant CV127 Soybean for Supply or Offer to Supply
EN
02 Oct 2013
  • - 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
  • BPS-CV127-9 - Herbicide-tolerant soybean
    | BASF S.A. Resistance to herbicides - Imidazolinone, Sulfonylurea
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 approval for importation for release [sale/placing on the market - for direct use as food, feed and for processing (FFP)] of a product of a Living Modified Organism (Imidazolinone-Tolerant CV127 soybean) and has determined that the release of this product does not endanger biological diversity or human, animal and plant health. GMAC recommends that the proposed application for release be APPROVED WITH TERMS AND CONDITIONS subject to approval by other relevant agencies.
EN
EN
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The event-specific method for the quantification of CV127 soybean is based on a real-time quantitative TaqMan PCR procedure to determine the relative content of CV127 to total soybean DNA in a sample. The protocol was shown to be capable of detecting 0.04 % CV127 soybean DNA in a mixture of non-transgenic soybean DNA. The protocol consists of a method module for DNA extraction from soybeans and a method module for event-specific quantification of CV127 soybean DNA. For quantitative event-specific detection of CV127 soybean two real-time PCR systems are used: a soybean-specific reference PCR system and a PCR system for event- specific detection of CV127 soybean. The soybean-specific reference PCR system is based on the sequences of the soybean Le1 (lectin) gene. The event-specific real- time PCR system for CV127 soybean is located at the 3' insert-to-genomic soybean DNA junction. The forward primer-binding site is located in the CV127 insert, the binding site of the reverse primer is within genomic soybean DNA and the binding site of the probe spans the junction between the CV127 insert and genomic DNA.
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Information sharing with other databases
Yes
Yes
Yes
Yes
Yes
Additional Information
EN
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