MON-87411-9
Commodity:
Corn / Maize
Traits:
Resistance to diseases and pests > Insects > Coleoptera
Resistance to herbicides > Other modes of action > Glyphosate
Indonesia
Country profileName of Product Applicant:
PT. Branita Sandhini
Application Summary:
GM Maize event MON 87411 (resistance to Coleoptera and tolerance to Glyphosate)
Authorization Date:
05/11/2018
Authorization Scope:
Food
Safety Assessment Summary:
Indonesia National Agency for Drug and Food certified food safety for GM Maize event MON 87411 (resistance to Coleoptera and tolerance to Glyphosate)
Detection Method:
Relevant Links:
Authorization expiration date, if any:
Relevant documents upload:
European Union
Country profileName of Product Applicant:
Monsanto
Application Summary:
The genetically modified MON-87411-9 maize expresses the CP4 EPSPS protein, which confers tolerance to glyphosate-containing herbicides, the Cry3Bb1 protein and the DvSnf7 dsRNA, which confer resistance to corn rootworm (Diabrotica spp.).
Authorization Date:
26/07/2019
Authorization Scope:
Food and feed
Safety Assessment Summary:
Please see the EU relevant links below.
Detection Method:
Method for detection: Event-specific real-time quantitative PCR based method for detection of the genetically modified maize MON 87411-9. Reference material: AOCS 0215-B is accessible via the American Oil Chemists Society. The relevant links are provided below.
Relevant Links:
Authorization expiration date, if any:
28/07/2029
Relevant documents upload:
Indonesia
Country profileName of Product Applicant:
Monsanto Indonesia (PT. Branita Sandhini)
Application Summary:
A genetically modified (GM) corn line with OECD Unique Identifier MON-87411-9, hereafter referred to as MON87411, has been developed by Monsanto Company (Monsanto).
The corn has been modified to be tolerant to the herbicide glyphosate through the expression of the enzyme 5-enolpyruvyl-3-shikimatephosphate synthase (CP4 EPSPS) encoded by the cp4 epsps gene derived from the common soil bacterium Agrobacterium sp. strain CP4.
The corn is also protected against corn rootworm (CRW) (Diabrotica spp.) through: the expression of a cry3Bb1 gene that produces a modified Bacillus thuringiensis (subsp. kumamotoensis) Cry3Bb1 protein to protect against CRW larval feeding and the expression of a suppression cassette containing an inverted repeat sequence that corresponds to a region of the DvSnf7 gene from western corn rootworm (Diabrotica virgifera virgifera).
Authorization Date:
05/11/2018
Authorization Scope:
Food
Safety Assessment Summary:
Please see the link provided (in Indonesian)
Detection Method:
Authorization expiration date, if any:
Relevant documents upload:
Ghana
Country profileName of Product Applicant:
Bayer
Application Summary:
Bayer West-Central Africa S.A. has applied requesting for authorisation of genetically modified Maize (Zea mays) Event MON 87411 with the OECD unique identifier MON-87411-9 for direct use as food, feed or for processing in Ghana.
The Maize Event MON 87411 expresses cry3Bb1 and cp4 epsps genes which encode Cry3Bb1 and CP4 EPSPS proteins, respectively conferring protection against corn rootworm (Diabrotica spp.) and tolerance to glyphosate, respectively. It also contains DvSnf7 suppression cassette that expresses an inverted repeat sequence designed to match the sequence in western corn rootworm (WCR) and thereby utilizes the RNA interference (RNAi) pathway to control corn rootworm (Diabrotica spp.). This Maize Event MON 87411 has been reviewed and approved for diverse uses (food, feed or for processing and/or cultivation) in several countries.
Authorization Date:
15/02/2024
Authorization Scope:
Food and feed
Safety Assessment Summary:
The Board of the NBA considered the recommendations from the Technical Advisory Committee
(TAC) following the Committee's thorough evaluation of the applications submitted by the
applicant using information available on:
i. the Biosafety Clearing House (BCH), which is a mechanism set up by the Cartagena
Protocol on Biosafety to facilitate the exchange of information on Living Modified
Organisms (LMOs) and assist the Parties to better comply with their obligations under the
Protocol and to which Ghana is a Party,
ii. the Organisation for Economic Co-operation and Development (OECD) Biotrack Product
Database,
iii. the Food and Agriculture Organisation of the United Nations (FAO) genetically modifled
foods platform.
The following considerations were evaluated:
J development of the modified events including the rnolecular biology data that characterizes
the genetic change;
,/ proximate analyses; major constituents (fats, proteins, carbohydrates) and minor
constituents (minerals and vitamins);
J composition of, and nutritional information (including anti-nutrients) on the GM products
compared to their conventional counterparts;
'/ the potential for causing allergic reactions;
,/ microbiological and chemical safety of the event(s);
J the potential for production of new toxins in the event(s); and,
J the potential for any unintended or secondary effects;
Detection Method:
Relevant Links:
Authorization expiration date, if any:
15/02/2027
Relevant documents upload:
New Zealand
Country profileName of Product Applicant:
Monsanto Australia Ltd
Application Summary:
A genetically modified (GM) corn line with OECD Unique Identifier MON-87411-9, hereafter referred to as MON87411, has been developed by Monsanto Company (Monsanto).
The corn has been modified to be both tolerant to the herbicide glyphosate and protected against corn rootworm (CRW) (Diabrotica spp.), an insect pest.
Tolerance to glyphosate is achieved through expression of the enzyme 5-enolpyruvyl-3-shikimatephosphate synthase (CP4 EPSPS) encoded by the cp4 epsps gene derived from the common soil bacterium Agrobacterium sp. strain CP4. The safety of the CP4 EPSPS protein has previously been assessed by FSANZ.
Protection against CRW occurs via two genetic modifications:
The expression of a cry3Bb1 gene that produces a modified Bacillus thuringiensis (subsp.kumamotoensis) Cry3Bb1 protein to protect against CRW larval feeding. The safety of the Cry3Bb1 protein has previously been assessed by FSANZ.
The expression of a suppression cassette containing an inverted repeat sequence that corresponds to a region of the DvSnf7 gene from western corn rootworm (Diabrotica virgifera virgifera). Expression of the inverted repeat results in the formation of a double-stranded RNA (dsRNA) transcript containing a fragment of the DvSnf7 gene. When ingested by CRW, it is recognised by the insect’s RNA interference (RNAi) machinery leading to the down regulation of the CRW DvSnf7 gene and ultimately death of the insect.
According to the Applicant, MON87411 will not be offered for commercial use as a stand-alone product, but will be combined, through traditional breeding, with other approved GM corn lines (a process known as ‘stacking’). It is further intended that any lines containing the MON87411 event will be grown in North America, and approval for cultivation in Australia or New Zealand is not being sought. Therefore, if approved, food derived from this line may enter the Australian and New Zealand food supply as imported food products.
Authorization Date:
31/12/2015
Authorization Scope:
Food
Safety Assessment Summary:
In conducting a safety assessment of food derived from MON87411, a number of criteria
have been addressed including: a characterisation of the transferred gene sequences, their
origin, function and stability in the corn genome; the changes at the level of DNA, protein and RNA in the whole food; compositional analyses; and evaluation of intended and unintended changes.
No potential public health and safety concerns have been identified in the assessment of
herbicide-tolerant and insect-protected corn line MON87411-9. On the basis of the data
provided in the present Application, and other available information, food derived from
MON87411 is considered to be as safe for human consumption as food derived from
conventional corn varieties.
Detection Method:
Relevant Links:
Authorization expiration date, if any:
Relevant documents upload:
Australia
Country profileName of Product Applicant:
Monsanto Australia Ltd
Application Summary:
A genetically modified (GM) corn line with OECD Unique Identifier MON-87411-9, hereafter referred to as MON87411, has been developed by Monsanto Company (Monsanto).
The corn has been modified to be both tolerant to the herbicide glyphosate and protected against corn rootworm (CRW) (Diabrotica spp.), an insect pest.
Tolerance to glyphosate is achieved through expression of the enzyme 5-enolpyruvyl-3-shikimatephosphate synthase (CP4 EPSPS) encoded by the cp4 epsps gene derived from the common soil bacterium Agrobacterium sp. strain CP4. The safety of the CP4 EPSPS protein has previously been assessed by FSANZ.
Protection against CRW occurs via two genetic modifications:
The expression of a cry3Bb1 gene that produces a modified Bacillus thuringiensis (subsp. kumamotoensis) Cry3Bb1 protein to protect against CRW larval feeding. The safety of the Cry3Bb1 protein has previously been assessed by FSANZ.
The expression of a suppression cassette containing an inverted repeat sequence that corresponds to a region of the DvSnf7 gene from western corn rootworm (Diabrotica virgifera virgifera). Expression of the inverted repeat results in the formation of a double-stranded RNA (dsRNA) transcript containing a fragment of the DvSnf7 gene. When ingested by CRW, it is recognised by the insect’s RNA interference (RNAi) machinery leading to the down regulation of the CRW DvSnf7 gene and ultimately death of the insect.
According to the Applicant, MON87411 will not be offered for commercial use as a stand-alone product, but will be combined, through traditional breeding, with other approved GM corn lines (a process known as ‘stacking’). It is further intended that any lines containing the MON87411 event will be grown in North America, and approval for cultivation in Australia or New Zealand is not being sought. Therefore, if approved, food derived from this line may enter the Australian and New Zealand food supply as imported food products.
Authorization Date:
06/08/2015
Authorization Scope:
Food
Safety Assessment Summary:
Detection Method:
Relevant Links:
Authorization expiration date, if any:
Relevant documents upload:
Paraguay
Country profileName of Product Applicant:
MONSANTO
Application Summary:
Commercial release. MON-87411-9 maize was modified to contain a suppression cassette that expresses an inverted repeat sequence designed to match the sequence of western corn rootworm (WCR). The expression of the suppression cassette results in the formation of a double-stranded RNA (dsRNA) transcript containing a 240 bp fragment of the WCR Snf7 gene (DvSnf7). Upon consumption, the plant-produced dsRNA in MON 87411 is recognized by the CRW’s RNA interference (RNAi) machinery resulting in down regulation of the targeted DvSnf7 gene leading to CRW mortality. MON 87411 also contains a cry3Bb1 gene that produces a modified Bacillus thuringiensis (subsp. kumamotoensis) Cry3Bb1 protein to protect against CRW larval feeding. In addition, MON 87411 contains the cp4 epsps gene from Agrobacterium sp. strain CP4 that encodes for the 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) protein, which confers tolerance to glyphosate.
Authorization Date:
08/11/2019
Authorization Scope:
Food and feed
Safety Assessment Summary:
The food and feed safety assessment was performed following the CODEX Guidelines.
Detection Method:
Relevant Links:
Authorization expiration date, if any:
Relevant documents upload:
Republic of Korea
Country profileName of Product Applicant:
Monsanto Korea Ltd.
Application Summary:
Glyphosate herbicide tolerance , Coleopteran insect resistance
Authorization Date:
28/09/2016
Authorization Scope:
Food and feed
Safety Assessment Summary:
Please see the link below(in Korean).
Detection Method:
Relevant Links:
Authorization expiration date, if any:
Relevant documents upload:
Malaysia
Country profileName of Product Applicant:
Monsanto Malaysia Sdn. Bhd.
Application Summary:
Please refer to the NBB Decision Document
Authorization Date:
10/11/2020
Authorization Scope:
Food and feed
Safety Assessment Summary:
Please refer to the Risk Assessment Report
Detection Method:
Relevant Links:
Authorization expiration date, if any:
Relevant documents upload:
Brazil
Country profileName of Product Applicant:
Monsanto do Brasil Ltda.
Application Summary:
Exemption from post-commercial release monitoring plan for genetically modified insect resistant and glyphosate tolerant corn MON 87411
Authorization Date:
05/08/2020
Authorization Scope:
Food and feed
Safety Assessment Summary:
In view of the above and considering the criteria contained in national legislation, it is possible to conclude that the exemption from the monitoring plan for genetically modified corn resistant to insects and tolerant to glyphosate MON 87411 meets the norms and legislation in force that aim to guarantee the biosafety of the environment , agriculture, human and animal health. Thus, this exemption from the post-commercial release monitoring plan of the genetically modified maize resistant to insects and tolerant to glyphosate MON 87411 was granted
Detection Method:
Molecular Traddcional methods.
Relevant Links:
Authorization expiration date, if any:
Relevant documents upload:
Japan
Country profileName of Product Applicant:
Monsanto Japan Ltd.
Application Summary:
MON 87411 line, a Maize Tolerant to Glyphosate and Resistant to Coleoptera
Authorization Date:
16/02/2017
Authorization Scope:
Food and feed
Safety Assessment Summary:
Please see the links below.
Detection Method:
Relevant Links:
Authorization expiration date, if any:
Relevant documents upload:
Singapore
Country profileName of Product Applicant:
Monsanto
Application Summary:
Apply for use as food, feed and for processing
Authorization Date:
08/05/2019
Authorization Scope:
Food and feed
Safety Assessment Summary:
Corn line MON87411 (MON-87411-9) contains three expression cassettes: (1) A DvSnf7 cassette contains two DvSnf7 fragments (from Diabrotica virgifera virgifera) in an inverted repeat sequence. Expression of the cassette results in the formation of a double-stranded RNA (dsRNA) transcript. When the dsRNA is ingested by the corn rootworm (CRW) insect, it triggers RNA interference (RNAi) of the CRW DvSnf7 gene, leading to death of the insect; (2) A cry3Bb1 cassette contains the cry3Bb1 gene (from Bacillus thuringiensis subsp. kumamotoensis ) that confers tolerance to CRW via the expression of the Cry3Bb1 protein which has a direct adverse effect on the gut of insects feeding on the plant; and (3) A cp4 epsps cassette contains the cp4 epsps gene (from Agrobacterium sp. strain CP4) that encodes a protein conferring tolerance to the herbicide glyphosate. MON87411 was generated through Agrobacterium-mediated transformation. Molecular analyses of MON87411 indicate there is a single insertion site comprising a single, complete copy of each of the three expression cassettes. The introduced genetic elements are stably inherited from one generation to the next. MON87411 expresses two novel proteins, Cry3Bb1 and CP4 EPSPS, which are non-toxic and non-allergenic to humans. Grain containing the DvSnf7 dsRNA is considered to be as safe as grain derived from conventional corn varieties. Grain from MON87411 is compositionally equivalent to grain from conventional corn varieties. Food derived from MON87411 is considered to be as safe as food derived from conventional corn varieties.
Detection Method:
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Authorization expiration date, if any:
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United States of America
Country profileName of Product Applicant:
Monsanto Company
Application Summary:
CornTrait 1 Added Protein or DNA: double stranded RNA with the partial sequence of the Snf7 transcript from the western corn rootwormSource: Diabrotica virgifera virgiferaIntended Effect: Resistance to Corn RootwormTrait 2 Added Protein or DNA: Cry3Bb1Source: Bacillus thuringiensisIntended Effect: Resistance to Corn RootwormTrait 3 Added Protein or DNA: 5-Enolpyruvylshikimate-3-phosphate synthase (EPSPS) from cp4 epsps geneSource: Agrobacterium strain CPRIntended Effect: Tolerance to the herbicide glyphosate
Authorization Date:
23/10/2015
Authorization Scope:
Food and feed
Safety Assessment Summary:
Please consult the website links below.
Detection Method:
Authorization expiration date, if any:
Relevant documents upload:
Mexico
Country profileName of Product Applicant:
Monsanto Comercial, S. de R. L. de C.V.
Application Summary:
Authorization by COFEPRIS: 151
Maize (Zea mays) genetically modified (MON-87411-9) resistant to coleoptera, suppression of the DvSnf7 gene and tolerant to the glyphosate herbicide. OECD Identifier: MON-87411-9
Authorization Date:
17/08/2015
Authorization Scope:
Food and feed
Safety Assessment Summary:
No toxic, allergic or substantial nutritional changes were observed. Therefore it can be ensured that the Genetically Modified Corn (Zea mays). OECD Identifier: MON-87411-9 is, based on existing knowledge to date, is as innocuous as its conventional counterpart.
Detection Method:
Relevant Links:
Authorization expiration date, if any:
Relevant documents upload:
Colombia
Country profileName of Product Applicant:
Compañia Agricola S.A.S
Application Summary:
Authorization of the genetically modified maize MON87411 resistant to coleoptera pest attack and tolerant to herbicide glyphosate
Authorization Date:
28/11/2016
Authorization Scope:
Food
Safety Assessment Summary:
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.
Detection Method:
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Authorization expiration date, if any:
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