Food safety and quality
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OECD Unique Identifier details

MON-87705-6
Commodity: Soyabean / Soybeans
Traits: Glyphosate tolerance,High oleic acid
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:
susti11@yahoo.com
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.  
Useful links
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).
Upload:
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:
fscj-secretariat@cao.go.jp
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,GOJ
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)