Food safety and quality
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OECD Unique Identifier details

MON-88Ø17-3xMON-ØØ81Ø-6
Commodity: Corn / Maize
Traits: Coleoptera resistance,Glyphosate tolerance,Lepidoptera resistance
European Union
Name of product applicant: Monsanto
Summary of application:

The genetically modified maize MON-88Ø17-3xMON-ØØ81Ø-6, as described in the application, expresses a modified Cry3Bb1 protein which provides protection to certain coleopteran pests, Cry1Ab protein which confers protection against certain lepidopteran insect pests and the CP4 EPSPS protein which confers tolerance to glyphosate herbicides.

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Date of authorization: 28/07/2010
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.): Biosafety Clearing House (BCH)
OECD BioTrack Product Database
Summary of the safety assessment:
Please see the EU relevant links below.
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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:
Event specific real-time quantitative PCR based method for genetically modified maize MON-88Ø17-3xMON-ØØ81Ø-6. - Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003. Please see the EU relevant links below.- Reference Material: AOCS 0406-D (MON-88Ø17-3) for accessible via the American Oil Chemists Society (AOCS) at http://www.aocs.org/tech/crm/corn.cfm and ERM®-BF413 (for MON-ØØ81Ø-6) accessible via the joint Research Centre (JRC) of the European Commission, the institute of Reference Materials and Measurements (IRMM) at http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Opinion of the European Food Safety Authority
Method for Detection
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Authorization expiration date: 27/7/2020
E-mail:
pablo.pindado-carrion@ec.europa.eu
Organization/agency name (Full name):
European Union
Contact person name:
Pablo PINDADO
Website:
Physical full address:
European Commission B232 04/106 1047 Brussels
Phone number:
00 32 2 298 67 06
Fax number:
Country introduction:
The process for authorising a new GMO is based on the EU regulation on GM food and feed (1829/2003). An application for authorising food or feed consisting of or made from a GMO must be submitted to the national authorities. The national authority then sends the application to the European Food Safety Agency (EFSA) for a risk assessment. EFSA then makes the application summary available to the public. No matter where in the EU the company applies, EFSA assesses the risks the GMO presents for the environment, human health and animal safety. If the application covers cultivation, EFSA delegates the environmental risk assessment to an EU country which sends EFSA its risk assessment report. After performing the risk assessment, EFSA submits its scientific opinion to the European Commission and to EU countries. The opinion is made available to the public, except for certain confidential aspects. Once EFSA publishes its risk assessment, the public has 30 days to comment on the Commission website for applications under Reg. 1829/2003, and on the Joint Research Centre website on the assessment report of the "lead" EU country for applications under Directive 2001/18. Within 3 months of receiving EFSA's opinion, the Commission grants or refuses the authorisation in a proposal. If it differs from EFSA’s opinion, it must explain why. National representatives approve the Commission’s proposal by qualified majority in: (1) The Standing Committee on the Food Chain and Animal Health if the application was submitted under Reg. 1829/2003; (2) The Regulatory Committee under Directive 2001/18/EC if the application was submitted under Dir. 2001/18. The proposal is adopted if the Committee agrees with it. If there is no opinion, the Commission may summon an Appeal Committee where EU countries can adopt or reject the proposal. If the Appeal Committee makes no decision, the Commission may adopt its proposal. Authorisations are valid for 10 years (renewable).
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Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Japan
Name of product applicant: Monsanto Japan Ltd.
Summary of application:

MON 88017 x MON 810 has been genetically modified for insect protection and glyphosate herbicide tolerance.

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Date of authorization: 10/11/2005
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.): OECD BioTrack Product Database
Summary of the safety assessment:
Please refer to the link 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)
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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.
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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)
Philippines
Name of product applicant: Monsanto Philippines
Summary of application:
A commercial inbred line with the inserted genes of MON 810 is developed by the conventional backcrossing of MON 810 and a non transgenic elite inbred line. The resulting commercial inbred line with the inserted genes of MON 810 is then crossed with another inbred line, which contains the inserted genes of MON 88017. The resulting seeds are stacked traits F1 hybrid variety
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Date of authorization: 01/07/2011
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:
Monsanto Philippines, Inc. has filed an application with attached technical dossiers to the Bureau of Plant Industry (BPI) for a biosafety notification for direct use as food, feed and for processing under Department of Agriculture (DA)- Administrative Order (AO) No. 8 Part 5 for combined trait corn: MON 88017 x MON 810 which has been genetically modified for insect protection and glyphosate herbicide tolerance. A safety assessment of combined trait product corn: MON 88017 x MON 810 was conducted as per Administrative Order No. 8 Series of 2002 and Memorandum Circulars Nos. 6 and 8, Series of 2004. The focus of risk assessment is the gene interactions between the two transgenes. Review of results of evaluation by the BPI Biotech Core Team in consultation with DA-Biotechnology Advisory Team (DA-BAT) completed the approval process.
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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:
E-mail:
bpibiotechsecretariat@yahoo.com
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Thelma L. Soriano
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 521 1080
Fax number:
632 521 1080
Country introduction:
The Philippines is the first ASEAN country to establish a modern regulatory system for modern biotechnology. The country's biosafety regulatory system follows strict scientific standards and has become a model for member-countries of the ASEAN seeking to become producers of agricultural biotechnology crops. Concerns on biosafety in the Philippines started as early as 1987 when scientists from the University of the Philippines Los Banos (UPLB) and International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI) and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD) recognized the potential for harm of the introduction of exotic species and genetic engineering. The joint committee formed the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. This proposal was eventually adapted into a Philippine Biosafety policy by virtue of Executive Order No 430, Series of 1990, issued by then President Corazon C. Aquino on October 15, 1990, which created the National Committee on Biosafety of the Philippines (NCBP). The NCBP formulates, reviews and amends national policy on biosafety and formulates guidelines on the conduct of activities on genetic engineering. The NCBP comprised of representative from the Department of Agriculture (DA); Department of Environment and Natural Resources (DENR); Health (DOH); and Department of Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science and 2 respected members of the community. The Philippines’ Law, Executive Order No.514 (EO514), Series of 2006 entitled “Establishing the National Biosafety Framework (NBF), Prescribing Guidelines for its Implementation, Strengthening the National Committee on Biosafety of the Philippines, and for Other Purposes was also issued. This order sets the establishment of the departmental biosafety committees in the DA, DENR, DOH and DOST. The mandates jurisdiction and other powers of all departments and agencies in relation to biosafety and biotechnology is guided by the NBF in coordination with the NCBP and each other in exercising its power. The Department of Agriculture (DA) issued Administrative Order No 8, Series of 2002, (DA AO8, 2002), which is part of EO 514, for the implementation of guidelines for the importation and release into the environment of plants and plant products derived from the use of modern biotechnology. The DA authorizes the Bureau of Plant Industry (BPI) as the lead agency responsible for the regulation of agricultural crops developed through modern biotechnology. The BPI has adopted a protocol for risk assessment of GM crops for food and feed or for processing based on the Codex Alimentarius Commission’s Guideline for the Conduct of Food Safety assessment of Foods Derived from Recombinant-DNA plants and a protocol for environmental risk assessment in accordance with the Cartagena Protocol on Biosafety and with the recommendation of the Panel of Experts of the Organization for Economic Cooperation and Development (OECD). DA AO8, 2002 ensures that only genetically food crops that have been well studied and found safe by parallel independent assessments by a team of Filipino scientists and technical personnel from the concerned regulatory agencies of the Department are allowed into our food supply and into our environment. The DA AO 8, 2002 has a step by step introduction of GM plant into the environment. The research and development phase would require testing the genetically modified (GM) crop under controlled conditions subject to regulation by the government agencies. The first stage of evaluation for GM crops is testing under contained facilities such as laboratories, greenhouses and screenhouses. After satisfactory completion of testing under contained facilities, confined environmental release or field trial is done. Confined field trial (CFT) is the first controlled introduction of the GM crop into the environment. The approval for field trial shall be based on the satisfactory completion of safety testing under contained conditions. Unconfined environmental release or commercialization of the product would follow after the safe conduct of the CFT. Approval for propagation shall only be allowed after field trials and risk assessment show no significant risk to human and animal health and the environment.
Useful links
Relevant documents
Stacked events:
Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004