Food safety and quality
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OECD Unique Identifier details

MON 87769
Commodity: Soyabean / Soybeans
Traits: High stearidonic acid
Iran
Name of product applicant: Monsanto
Summary of application:

The development of MON 87769 involved the introduction of two desaturase genes, Primulae juliae  Δ6 desaturase (Pj.D6D) and  Neurospora crassa  Δ15 desaturase (Nc.Fad3) that result in the seed-specific production of the PjΔ6D and NcΔ15D proteins. This results in the increased synthesis of stearidonic acid (SDA) in the LM soybean.
 


 


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Date of authorization: 08/05/2019
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Competent National Authority: Ministry of Health and Medical Education- Food & Drug Administration. Risk Assessment file is uploaded. https://bch.cbd.int/en/database/RA/BCH-RA-IR-115199/1
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
ABRII
Contact person name:
Gholamreza Salehi Jouzani
Website:
Physical full address:
Agricultural Biotechnology Research Institute of Iran (ABRII), Mahdasht Road, 31535-1897, Karaj, Iran
Phone number:
0098(26)32701132
Fax number:
0098(26)32701132
Country introduction:

Iran has ratified Cartagena Protocol on Biosafety in 2003. The National Biosafety Law has also been ratified in 2009. The regulations for the National Biosafety Law have been prepared and approved during last ten years. All these laws and regulations deal with Living GMOs (LMOs) and there is no Law for the regulation of the non-living GMOs. All these laws and regulations are accessible at: http://bch.cbd.int/database/results?searchid=622770. Codex principles for the risk analysis of foods derived from modern biotechnology and other guidelines such as the Codex guidelines for the conduct of food safety assessment of foods produced using recombinant-DNA plants and microorganisms are widely accepted and used.

The process for authorization of new LMO release includes comprehensive risk assessment and management analysis. Ministry of Agriculture (Jihade Keshavarzi) is responsible for approval of the release, import, export, transit and use of Agricultural Related LMOs. The requests should be forwarded to: a[email protected]; with a CC to National Focal Point: [email protected]. Cartagena Protocol on Biosafety National Focal Point is in charge of all liaison affairs related to the Cartagena Protocol on Biosafety and acts as the contact point for the communications received. The Ministry of Health and Medical Education is in charge with the approval of all LMOs related to food and medicine. Environmental Protection Organization is in charge with the environmental release of LMOs in the wild nature and/or related to the wild organisms. Detailed procedure for authorization of GM food and feed is under preparation.

Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Agricultural Jihad Ministry
 
Tehran, Tehran
Iran (Islamic Republic of)
Phone: +98-21-64583301
Fax: +98-21-88947075
Email: [email protected]
Url: http://www.maj.ir

 

Ministry of Health and Medical Education- Food & Drug Administration
Food and Drug Administration, Fakhrerazi St., Enghelab Ave.
Tehran
Iran (Islamic Republic of), 1314715311
Phone: 009821-61927130
Fax: 009821-66405570
Email: [email protected],[email protected]
Url: http://fda.behdasht.gov.ir/