| | english | español | français |
Go to record ID

  Home|Finding Information|Record details   Printer-friendly version

Country's Decision or any other Communication
Record information and status
Record ID
107814
Status
Published
Date of creation
2015-04-07 07:56 UTC (johnny@nre.gov.my)
Date of last update
2020-08-03 06:47 UTC (anita@biosafety.gov.my)
Date of publication
2020-08-03 06:47 UTC (anita@biosafety.gov.my)

General information
Country submitting the decision or communication
  • Malaysia
Competent National Authority(ies) responsible for the decision or communication
Department of Biosafety Malaysia
Level 1, Podium 2, Wisma Sumber Asli
No. 25, Persiaran Perdana, Precinct 4
Putrajaya
Malaysia, 62574
Phone:+603 8886 1579,+603 8886 1746
Fax:+603-8890 4935
Email:dob@biosafety.gov.my
Url:Department of Biosafety Malaysia
Title / Reference number of the decision or communication
JBK(S) 602-1/1/20
Date of the decision
2015-02-17
Is the decision taken prior to entry into force of the Protocol?
No
Is this an amendment to a previous decision / communication?
No
Decision or communication details
Subject(s) of the decision
  • Decision on LMOs for intentional introduction into the environment (according Article 10 or domestic regulatory framework)
Was the decision triggered by a request for a transboundary movement of LMOs into the country?
No
Does the decision apply to transboundary movements of LMO(s) into the country?
No
Importer’s or Applicant’s contact details
Mr Mohd Alhafis Rusdi
Technology Officer
EntoGenex Industries Sdn. Bhd.
D-3A-08, Plaza Mont' Kiara, No 2 Jalan Kiara, Mont' Kiara
Kuala Lumpur
Malaysia, 50480
Phone:+603 6203 5531/5532
Email:al@entogenex.com
Url:http://entogenex.com/2014/
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
1) Release is limited to the TMOF_yeast imported from India to be formulated as Mousticide WP and Mousticide RH as end products and Mousticide WP product imported from Philippines. Any other formulation will required a new application for approval to be submitted to the NBB.
2) Product handling and safety instructions should be provided with the product. These instructions should include:
a) the use of PPE and follow up medical supervision of staff handling the product.
b) caution be exercised when used in combination with other larvicidal products since the safety of the combined effects have not been established.
3) Labelling should include application dosage and frequency, instructions for disposal as well as hazard warning.
4) Imported TMOF_yeast should be accompanied with data sheet that should include information on safety and standardized potency range of the product.
5) Post monitoring survey of end user to determine the effect on human health and environment. The survey should clearly outline the safety objectives to the end user and a brief product description.
6) Continuous environmental safety studies on effects of Mousticide WP and Mousticide RH to the Malaysian fauna are recommended. These studies should be carried out on the oil palm weevil and honey bee using the TMOF_yeast produced by IBD as well as TMOF_yeast imported from India.
7) Mousticide WP and Mousticide RH should not be applied to waterways such as treated drinking water sources.
8) Should the approved person receive any credible and/or scientifically proven information that indicates any adverse effect of Mousticide WP or Mousticide RH either locally or in other countries, the NBB authority shall be informed immediately.
9) If the production is to be done in a facility other than IBD, UTM, a notification of that chosen facility for contained use activity must be submitted to the NBB.
Reasons
This is to ensure that the product will not endanger the environment, human and animal health including non target organism.
Does the decision involve field trials?
No
Does the decision involve commercial release?
Yes
LMO identification
MOUSTICIDE™
Mr Mohd Alhafis Rusdi Changes in quality and/or metabolite content - Protein and amino acids
Risk assessment
Risk Assessment Report of the Genetic Modification Advisory Committee (GMAC) for an Approval to Import TMOF_Yeast to Produce Mousticide RH and Mousticide WP and Import of Mousticide WP for Release
MOUSTICIDE™
Mr Mohd Alhafis Rusdi

Changes in quality and/or metabolite content - Protein and amino acids