Food safety and quality
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OECD Unique Identifier details

MON-87705-6
Commodity: Soyabean / Soybeans
Traits: Glyphosate tolerance,High oleic acid
Colombia
Name of product applicant: Compañia Agricola S.A.S
Summary of application:

Authorization of the genetically modified soy MON87705 tolerant to the herbicide glyphosate andd reduce enzimatic activity FATB and FAD2

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Date of authorization: 25/07/2019
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):
Based on the risk assessment, it can be concluded that the event shows the same risks as its conventional counterpart. Therefore the National Technical Biosafety Committee for GMO use exclusively in Health and human consumption (CTNSalud) recommends its authorization
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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):
Ministerio de salud y proteccion social
Contact person name:
Daniel Rubio
Website:
Physical full address:
Carrera 13 No. 32- 76 piso 12, Bogotá
Phone number:
330 5000 ext 1256
Fax number:
Country introduction:

The 4525 decree of 2005, established the Ministry of Health and Social Protection as the competent authority for GMO for health and food purposes and creates the National Biosafety Technical Committee for GMO's used in health and food purposes (CTNSalud).

The CTNSalud is composed by the Ministry of Health and Social Protection, the National Food and Drug Surveillance Institute (INVIMA) and the Technology and Innovation Administrative Department (COLCIENCIAS). This committee is responsible for the assesment of risk assessments; to inquire for any additional information; assessment of any measurements in accordance to the Cartagena Protocol; and the recommendation for the authorization of GMO for health or food purposes.

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Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Indonesia
Name of product applicant: Monsanto Indonesia (PT. Branita Sandhini
Summary of application:

The genetically modified soybean is soybean tolerant to glyphosate herbicide and contains low saturated fatty acid and high oleic acid

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Date of authorization: 13/06/2013
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):
Please refer to the document (in Indonesian)
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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):
Indonesian Agency for Agricultural Research and De
Contact person name:
Sustiprijatno
Website:
Physical full address:
BB Biogen Jl Tentara Pelajar 3A Bogor 16111 Indonesia
Phone number:
+622518333440
Fax number:
+622518334420
Country introduction:
  1. Indonesia has  ratified Protocol  on Biosafety to the  Convention on Biological Diversity (CBD) through the Indonesian Law No. 21 / 2004.  In the implementation, biosafety  assessment for GM products, based on Goverment Regulation Number 21 /2005, Indonesia  has regulated GM products on  several items including : product kinds and requrements, research and developement,  product importation,  product assessment, release and distribution, supervision and monitoring, and institution and financing. We have also Law for food  No. 18 /2012 which also consists of regulation for GM food.
  2. Indonesia already have procedure /application on GMO  biosafety assessment and National Authorized Institution who conducting  the biosafety  assessment .  Each GM food  should have authorization from Goverment  before it can be released and distributed. An application for authorisation for new  GM food  should be submited to  Biosafety Commision  through related Ministry or authorised Non Departement Goverment Agency (LPND) . Biosafety Commision, then sends the application to the National Agency for Drug and Food Control (Badan POM) for technical team to evaluate  the GM food safety.  The recommendation by technical team will be sent  back  to Biosafety Commision. The recommendation and GM Food safety certificate will be released by Biosafety Commision to the applicant through  related ministry or LPND.  
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Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

National Agency of Food and Drug Control (BPOM): http://www.pom.go.id/new/home/en

Japan
Name of product applicant: Monsanto Japan Ltd.
Summary of application:

Low saturated fatty acid and high oleic acid soybean tolerant to glyphosate herbicide (FAD2-1A, FATB1-A, modified cp4 epsps, Glycine max (L.) Merr.).

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Date of authorization: 25/09/2012
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.): OECD BioTrack Product Database
Summary of the safety assessment (food safety):
Please see the links below (in Japanese).
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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: Food safety assessment performed by Food Safety Commission of Japan (in Japanese), Food
Food safety assessment performed by Food Safety Commission of Japan (in Japanese), Feed
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,
Contact person name:
Mariko Murakami
Website:
Physical full address:
Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number:
81 3 6234 1122
Fax number:
81 3 3584 7392
Country introduction:
Safety assessments of GM foods are mandatory under the Food Sanitation Law in Japan. The Ministry of Health, Labour, and Welfare (MHLW) legally imposes safety assessments of GM foods so that those that have not undergone safety assessments would not be distributed in the country. MHLW receives application and requests the Food Safety COmmission of Japan (FSCJ) to evaluate the safety of GM foods in terms of human health. Safety assessments are carried out by FSCJ.
Useful links
Relevant documents
Stacked events:

With regard to stacked events, FSCJ conducts the safety assessment of GM food based on the “Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants”.

Even if single events that are stacked have already approved, some products will be considered as new products and some will not.

Please refer to Article 5 and 6 of the MHLW’s notice, which is available at the following URL, for the details.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000053519.pdf

Article 6 was modified in 2014, and the modified version is available at the following URL.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000049695.pdf

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

Food Safety Commission of Japan (http://www.fsc.go.jp/english/index.html), Ministry of Health, Labour and Welfare (http://www.mhlw.go.jp/english/policy/health-medical/food/index.html)

Malaysia
Name of product applicant: Monsanto Malaysia Sdn. Bhd.
Summary of application:

Please refer to the NBB Decision Document

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Date of authorization: 10/11/2020
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.): Department of Biosafety Malaysia
CBD Biosafety Clearing House
Summary of the safety assessment (food safety):
Please refer to the Risk Assessment Report
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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):
Department of Biosafety Malaysia
Contact person name:
Dr. Anita Anthonysamy
Website:
Physical full address:
Department of Biosafety Ministry of Environment and Water Level 4, Block F11, Complex F Lebuh Perdana Timur, Precinct 1 62000 Putrajaya, Malaysia
Phone number:
+60380917322
Fax number:
+60380917371
Country introduction:

GM food safety assessment is a requirement by law under the Biosafety Act 2007 in Malaysia. The National Biosafety Board reviews and makes decisions on events based on a scientific/technical risk assessment, policy considerations as well as public input. The decisions and its related documents made are publicly available through the Malaysian Department of Biosafety Website and the Convention of Biological Diversity Biosafety Clearing House.

Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Department of Biosafety Malaysia, Level 1, Podium 2, Wisma Sumber Asli No. 25, Persiaran Perdana, Precinct 4 Putrajaya, Federal Territory Malaysia, 62574. Phone: +603 8886 1746 / 1579. Fax: +603-8889 5604 Email: [email protected] Url: www. biosafety.gov.my

 

Food Safety and Quality Division, Ministry of Health, Level 4, Menara Prisma, No. 26, Persiaran Perdana, Putrajaya, Malaysia, 62675. Phone: +603 88850797 Fax: +603 88850790 Email: [email protected]
Singapore
Name of product applicant: Monsanto
Summary of application:

Apply for use as food or feed or for processing 

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Date of authorization: 25/02/2015
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):
Soybean line MON87705 (MON-87705-6) is genetically modified with increased levels of oleic acid with an associated decrease in levels of linoleic acid and saturated fatty acids, relative to conventional soybean oils. This is achieved using a gene silencing mechanism to specifically down-regulate the expression in seeds of two endogenous genes encoding key enzymes, FATB and FAD2, involved in fatty acid biosynthesis. MON87705 also contains the cp4 epsps gene from Agrobacterium sp. strain CP4, that confers tolerance to glyphosate-containing herbicides. Molecular characterisation of MON87705 showed that a functional two gene suppression cassette and intact cp4 epsps gene co-integrated into the soybean genome at a single insertion site. The complete FAD2-1A/FATB1-A suppression cassette, under the control of a seed specific promoter, expresses an RNA that contains an inverted repeat of the soybean fad2-1a and fatb1-a gene segments. The RNA transcript forms a double-stranded RNA structure (hairpin) that suppresses endogenous FATB and FAD2 RNA levels via RNA interference (RNAi) mechanisms, subsequently leading to the desired fatty acid phenotype. The genetic elements introduced into MON87705 were demonstrated to be stably integrated into the soybean genome. The CP4 EPSPS protein is neither toxic nor allergenic in humans. Except for the intended changes to four major fatty acids, the composition of MON87705 seed is comparable to that of the conventional soybean. Food derived from soybean MON87705 is considered as safe as food derived from conventional soybean.
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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)
E-mail:
Organization/agency name (Full name):
Singapore Food Agency (SFA)
Contact person name:
Dr Tan Yong Quan
Website:
Physical full address:
52 Jurong Gateway Road 14-01 JEM Office Tower Singapore 608550
Phone number:
(65)68052750
Fax number:
Country introduction:

The Singapore Food Agency (SFA) is a Statutory Board established under the Ministry of Sustainability and the Environment (MSE) to oversee food safety and security. SFA’s mission is to ensure and secure a supply of safe food.  SFA adopts a risk-based approach to food safety. Foods with foodborne hazards that may pose potential food safety risks to consumers are subjected to more stringent checks, regardless of their country of origin. SFA has in place an integrated system to ensure that both imported and domestically produced foods are safe for consumption.  The system comprises control measures such as source accreditation, inspection and surveillance of food, laboratory analysis, food legislation and recall of food products, which safeguard food safety from farm to fork.

Useful links
Relevant documents
Stacked events:

More information on the guidelines for the safety assessment of stacked events can be found on GMAC’s website:

http://www.gmac.sg/Index_Singapore_Guidelines_on_the_Release_of_Agriculture_Related_GMOs.html

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

Singapore Food Agency (SFA)