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Country's Decision or any other Communication
(DEC)
published: 07 Apr 2015
last updated: 03 Aug 2020
No
JBK(S) 602-1/1/20
EN
17 Feb 2015
No
- Decision on LMOs for intentional introduction into the environment (according to Article 10 or domestic regulatory framework)
No
No
-
Person:Mr Mohd Alhafis RusdiTechnology Officer,D-3A-08, Plaza Mont' Kiara, No 2 Jalan Kiara, Mont' KiaraKuala Lumpur,
50480, MalaysiaPhone: +603 6203 5531/5532,Fax:Email: al@entogenex.com,Website: http://entogenex.com/2014/,Related OrganizationEntoGenex Industries Sdn. Bhd. ()Private sector (business and industry)D-3A-08, Plaza Mont' Kiara, No 2 Jalan Kiara, Mont' KiaraKuala Lumpur,
50480, MalaysiaPhone: +603 6203 5531/5532,Fax:Email: al@entogenex.com,Website: http://entogenex.com/2014/,
No
Yes
Yes
Approval of the import and/or use of the LMO(s) with 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.
EN
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.
This is to ensure that the product will not endanger the environment, human and animal health including non target organism.
EN
-
BCH-LMO-SCBD-106444-1 Living Modified Organism MOUSTICIDE™EntoGenex Industries Sdn. Bhd. | Changes in quality and/or metabolite content (Protein and amino acids)
-
BCH-RA-MY-107813-2 Risk Assessment generated by a regulatory process 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 ReleaseMOUSTICIDE™ | Yeast, PICPA, Changes in quality and/or metabolite content
- NBB Decision_EntoGenex_TMOF & Mousticide [ English ]
- Department of Biosafety Malaysia [ English ]