Food safety and quality
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OECD Unique Identifier details

BPS-CV127-9.
Commodity: Soyabean / Soybeans
Traits: Herbicide tolerance
Iran
Name of product applicant: BASF Plant Science
Summary of application:

Genetically modified soybean line BPS-CV127-9 expresses the acetohydroxyacid synthase large sub-unit from Arabidopsis thaliana which confers tolerance to the imidazolinone herbicides.


 
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Date of authorization: 23/04/2018
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-114069/2
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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:
[email protected]
Organization/agency name (Full name):
ABRII
Contact person name:
Gholamreza Salehi Jouzani
Website:
http://microbial.abrii.ac.ir/en/ShowMember/31/Gholamreza-SalehiJouzani
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
Laws and Regulations- Iran BCH
Decisions- Iran BCH
Risk Assessments- Iran BCH
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/

 

Paraguay
Name of product applicant: BASF
Summary of application:

The csr1-2 coding sequence from Arabisopsis thaliana is 2013 bp long and includes the S653N point mutation which confers tolerance to imidazolinone herbicides.

In CV127, transcription is directed by the 5’ and 3’ untranslated regions (UTR) containing the putative promoter and terminator regions, respectively, of the csr1-2 gene from Arabidopsis thaliana.

In addition to the S653N mutation found in the donor organism, DNA sequence analysis revealed that the csr1-2 gene cassette contains three point mutations relative to the PvuII linear DNA fragment of pAC321. One of the point mutations is a G to A mutation at position 272 in the csr1-2 gene, which results in an amino acid change from arginine to lysine. The other two mutations are genetically silent.

Sequence analysis revealed that parts of the PvuII transformation fragment are not contained within the transgene insert in CV127. Deletions of unannotated Arabidopsis genomic DNA occurred both at the 5’ end and 3’ end during insertion into the soybean genome.
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Date of authorization: 20/02/2014
Scope of authorization: Food and feed
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):
The Commercial Release Opinion of the National Commission for Agricultural and Forestry Biosafety (CONBIO), in its substantial part states: "...Recommends technically: (1) The commercial release of the event CV127 (2) In case of detection of an unexpected effect, the company is obliged to inform CONBIO".
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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:
Upload:
Authorization expiration date (a blank field means there is no expiration date) no
E-mail:
[email protected]
Organization/agency name (Full name):
Ministerio de Agricultura y Ganadería
Contact person name:
Santiago Bertoni
Website:
http://conbio.mag.gov.py
Physical full address:
Yegros 437 entre 25 de mayo y Cerro Cora
Phone number:
+595 981 256262
Fax number:
Country introduction:

The agricultural sector is one of the economic pillars of Paraguay in its contribution to the GDP, with the main crops being soybean, cassava, maize, wheat, sugar cane, and cotton. It should also be noted that Paraguay is the world’s fourth exporter of soybean. In 2020, the area planted with crops was 4.67 million hectares and consisted of soybean (3.56 million hectares), maize (1.08 million hectares), and cotton (18,000 hectares). Agricultural biotechnology was first regulated in Paraguay in 1997. In 2012, the system was adjusted through the creation of the National Agricultural and Forestry Biosafety Commission (CONBIO), “with the mission to manage, analyze, and issue recommendations on all matters related to the introduction, confined field trials, pre-commercial and commercial release, and other intended uses of GE crops” Almost 94% of the soybean, 36% of the maize, and 56% of the cotton planted in the country are GE.

Useful links
CONBIO
Paraguay’s Path Toward the Simplification of Procedures in the Approval of GE Crops
Relevant documents
Stacked events:

When a stacked event is approved, all possible combinations are approved. Previously evaluated single events are not reevaluated in stacks.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

In 2012, the system was adjusted through the creation of the National Agricultural and Forestry Biosafety Commission (CONBIO), “with the mission to manage, analyze, and issue recommendations on all matters related to the introduction, confined field trials, pre-commercial and commercial release, and other intended uses of GE crops”. Additional information https://conbio.mag.gov.py/