Food safety and quality
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OECD Unique Identifier details

REN-ØØØ38-3xMON-ØØ81Ø-6
Commodity: Corn / Maize
Traits: Increased lysine content,Lepidoptera resistance
Argentina
Name of product applicant: Monsanto Argentina S.A.I.C.
Summary of application:
The stacked event LY038xMON810 maize confers resistance to lepidopteran insects and lysine high content to grain. Both parental events, LY038 and MON810, were stacked by conventional crossing (sexual). The stacked event has the cry1Ab gene from MON810 event and the gene cordapA from LY038 event. The transgenes are inherited in independent form, since it presents mendelian segregation. Moreover, the applicant proved the gene stability and the effective levels of the expressed proteins. The protein Cry1Ab confers resistance to certain lepidopteran insects and the cDHDPS protein allows to raise the level of lysine in the grain.
After comparison of 85 analytes measured in grain and forage, in the compositional analysis study, it is concluded that maize LY038xMON810 is equivalent to conventional maize except for the intentional increase levels of free lysine and total lysine in grain and increase levels of lysine associated catabolites: saccharopine and α -aminoadipic acid. Also no unexpected effects were found in a 42 day feeding study conducted in broilers with maize grain LY038xMON810.
The allergenicity and toxicity assessment of the new expression proteins were carried out previously in both single events.
Taking into account the assessment of genetic stability, molecular characterization, products and levels of expression, compositional analyses and morphoagronomic studies, no metabolic interaction is expected that might impact on the food safety when single events are stacked in a conventional way.
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Date of authorization: 04/04/2008
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:
Please see decision document weblinks
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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: Principles for the Assessment of Food and Feed derived from GMO in Argentina - Resolution Nº 412
Decision document of food/feed safety assessment of event LY038xMON810
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Authorization expiration date:
E-mail:
mjunco@senasa.gov.ar
Organization/agency name (Full name):
SENASA (National Service for Agrifood Health and Quality)
Contact person name:
Mariano Junco
Website:
Physical full address:
Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number:
54 11 4121 5276
Fax number:
54 11 4121 5258
Country introduction:
The food risk assessment process of transformation events, as the result of modern biotechnology, is carried out by the National Service for Agrifood Health and Quality (Senasa), regulatory agency depending on the Ministery of Agriculture, Livestock and Fisheries. The Agrifood Quality Directorate of Senasa, is the area responsible for carrying out this task. It has an specific scientific team and the advise of a Technical Advisory Committee composed of experts from different scientific disciplines representing different sectors involved in the production, industrialization, consumption, research and development of genetically modified organisms.
Useful links
Relevant documents
Stacked events:
Argentina hasn't a specific authorization mechanism for food/feed safety assessment for stacked events. In principle, stacked events are assessed like another single event on a case-by-case basis.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
National Service for Agrifood Health and Quality (Senasa) (http://www.senasa.gov.ar)
Japan
Name of product applicant: Monsanto Japan Ltd.
Summary of application:

LY038xMON810 maize has genetically modified for High lysine and Lepidoptera resistant (cordapA, cry1Ab, Zea mays subsp. mays (L.) Iltis).

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Date of authorization: 12/11/2007
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:
Please see the link 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)
Upload:
Authorization expiration date:
E-mail:
fscj-secretariat@cao.go.jp
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,GOJ
Contact person name:
Ryusuke Matsuoka
Website:
Physical full address:
Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number:
81 3 6234 1119
Fax number:
81 3 3584 7392
Country introduction:
The safety assessment of foods and food additives produced by recombinant DNA techniques (hereafter GM foods) is mandatory under the Food Sanitation Law. The Ministry of Health, Labour, and Welfare (MHLW) receives application from Applicant and requests the Food Safety Commission of Japan (FSCJ) to evaluate the safety of GM foods, and the FSCJ evaluates the safety in terms of human health. Within the FSCJ, the Expert Committee of Genetically Modified Foods conducts safety assessments based on following standards and policies (1) Standards for the Safety Assessment of Genetically Modified Foods (2) Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants (3) Standards for the Safety Assessment of Food Additives Produced Using Genetically Modified Microorganisms (4) Policies Regarding the Safety Assessment of Highly Purified Non-Protein Food Additives including Amino Acids Produced Using Genetically Modified Microorganisms It is forbidden to import or sell genetically modified foods or food products made from such foods that have not undergone safety assessment. After FSCJ submits a notification to MHLW, MHLW gives notice on the Official Gazette.
Useful links
Relevant documents
Stacked events:
With regard to stacked events, FSC conducts the Safety Assessment of GM Foods based on the “Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants”
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)
Japan
Name of product applicant: Monsanto Japan Ltd.
Summary of application:

LY038xMON810 maize has genetically modified for High lysine and Lepidoptera resistant (cordapA, cry1Ab, Zea mays subsp. mays (L.) Iltis).

Upload:
Date of authorization: 12/11/2007
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:
Please see the link 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)
Upload:
Authorization expiration date:
E-mail:
fscj-secretariat@cao.go.jp
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,GOJ
Contact person name:
Ryusuke Matsuoka
Website:
Physical full address:
Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number:
81 3 6234 1119
Fax number:
81 3 3584 7392
Country introduction:
The safety assessment of foods and food additives produced by recombinant DNA techniques (hereafter GM foods) is mandatory under the Food Sanitation Law. The Ministry of Health, Labour, and Welfare (MHLW) receives application from Applicant and requests the Food Safety Commission of Japan (FSCJ) to evaluate the safety of GM foods, and the FSCJ evaluates the safety in terms of human health. Within the FSCJ, the Expert Committee of Genetically Modified Foods conducts safety assessments based on following standards and policies (1) Standards for the Safety Assessment of Genetically Modified Foods (2) Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants (3) Standards for the Safety Assessment of Food Additives Produced Using Genetically Modified Microorganisms (4) Policies Regarding the Safety Assessment of Highly Purified Non-Protein Food Additives including Amino Acids Produced Using Genetically Modified Microorganisms It is forbidden to import or sell genetically modified foods or food products made from such foods that have not undergone safety assessment. After FSCJ submits a notification to MHLW, MHLW gives notice on the Official Gazette.
Useful links
Relevant documents
Stacked events:
With regard to stacked events, FSC conducts the Safety Assessment of GM Foods based on the “Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants”
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)