| Commodity: |
Corn / Maize |
| Traits: |
Insect resistance |
| Name of product applicant: |
Monsanto Argentina S.R.L. |
| Summary of application: |
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| Date of authorization: |
29/10/2021 |
| 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.): |
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| Summary of the safety assessment (food safety): |
Organism subject to control:
Corn has a history of safe consumption and does not represent a concern for human or animal health based on its intended use.
Donor organisms and introduced genes:
- Cry1B.868: Bacillus thuringiensis
- Cry1Da_7: Bacillus thuringiensis
None of the elements present in the constructions used and expressed in this event has characteristics that represent a concern for human or animal health.
Characterization of the event:
MON-95379-3 maize was obtained by Agrobacterium tumefaciens-mediated transformation of immature embryos of the conventional LH244 maize line, and has the following characteristic:
- Protection against damage caused by susceptible lepidopteran insect pests.
Molecular characterization:
The plasmid vector PV-ZMIR522223 was used, which contains a single T-DNA, which encodes the expression cassettes of the Cry1B.868 and Cry1Da_7 proteins.
Insertion occurred at a single locus, did not disrupt any gene or other genetic element in the maize genome, is stable, and is inherited according to Mendelian principles of inheritance.
In the event MON-95379-3, the absence of sequences from the plasmid backbone outside the T-DNA region was corroborated, as well as the selection marker cp4epsps that was cleaved by the Cre recombinase, together with a loxP site, and not it is present in the MON 95379-3 sequence.
Compositional Analysis:
In the composition studies that were presented, no consistent significant differences were identified between the maize carrying the MON-95379-3 event and the non-transgenic controls, the values being within the ranges of the natural variability of maize reported in the literature.
The results obtained show that the analyzed event is substantially equivalent to its non-transgenic counterpart. The statistically significant differences found were not compositionally relevant from the perspective of the safety of food and feed derived from corn MON-95379-3.
Allergenic and Toxicological Characteristics:
The Cry1B.868 and Cry1Da_7 proteins originate from Bt, an organism that has not been reported as a source of known allergens or toxins for humans.
The Cry1B.868 and Cry1Da_7 proteins represent a small proportion of the total proteins in the corn kernel in the MON-95379-3 event.
Bioinformatic analyzes showed that the Cry1B.868 and Cry1Da_7 proteins do not share amino acid sequence homology with known allergens, gliadins, glutenins, so it is very unlikely that they contain allergenic cross-reactivity epitopes, and neither with toxic proteins that could cause an adverse effect on the health of people or animals, other than the effects on the target insect species.
In vitro experiments demonstrated that the Cry1B.868 and Cry1Da_7 proteins are rapidly digested by pepsin and pancreatin (proteases found in the human gastrointestinal tract) under physiological conditions, and are rapidly denatured at high temperatures.
On the other hand, the study of possible open reading frames (ORF) determined the absence of sequence similarity between the potential peptides that would be hypothetically generated, with known allergens or toxins in the consulted databases.
Feeding studies with the whole food:
There is no evidence to support the need to request additional studies in animals or feeding trials using the complete food, taking into account that:
- There is compositional equivalence of the event in relation to its conventional comparator.
- No adverse effects and toxic and / or allergenic characteristics for humans were observed in the expressed proteins.
Based on the foregoing, the feeding studies in animals with the complete food will not provide additional relevant information in terms of the evaluation of safety and nutritional quality of foods derived from MON-95379-3 corn.
In accordance with the foregoing, taking into account the available scientific knowledge and internationally accepted requirements and criteria, it is concluded that the maize that carries the MON-95379-3 event, with protection against damage caused by susceptible lepidopteran insect pests, is as safe and no less nutritious than its conventional counterpart, so there are no objections to its approval for human and animal consumption. |
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E-mail:
Organization/agency name (Full name): Ministerio de Agroindustria
Contact person name: Andrés Maggi
Website:
Physical full address: Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number: 54 11 5222 5986
Fax number:
Country introduction: In Argentina, the food and feed 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). The General Office of Biotechnology, is the area responsible for carrying out this task. It has an specific professional team and the advise of a Technical Advisory Committee composed of experts from several scientific disciplines representing different sectors involved in the production, industrialization, consumption, research and development of genetically modified organisms. Useful links
Relevant documents
Stacked events: Stacked events with all single events approved, are assessed as a new event, but with much less requirements, always 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)
https://www.argentina.gob.ar/senasa
https://www.argentina.gob.ar/senasa/programas-sanitarios/biotecnologia
| Name of product applicant: |
Bayer CropScience Proprietary Limited |
| Summary of application: |
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| Date of authorization: |
27/04/2022 |
| 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 database
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| Summary of the safety assessment (food safety): |
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A1226 - Food derived from insect protected corn line MON95379
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E-mail:
Organization/agency name (Full name): Food Standards Australia New Zealand
Contact person name:
Website:
Physical full address: Level 4, 15 Lancaster Place, Majura Park ACT 2609, Australia
Phone number: +61 2 6271 2222
Fax number: +61 2 6271 2278
Country introduction: Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 115 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 10 staff) is located in Wellington on the North Island. Useful links
Relevant documents
Stacked events: FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)
No separate approval or safety assessment is necessary for foods derived from a stacked GM line that is the result of traditional breeding between a number of GM parent lines for which food has already been approved. Food from the parent lines must be listed in the Australia New Zealand Food Standards Code. The parent lines may contain any number of different genes. If food from any of the GM parent lines has not been approved, then a full pre-market safety assessment of food from the stacked line must be undertaken.
No separate approval is required for food derived from a line that is the product of a GM line, for which food has been approved, crossed traditionally with a non-GM line.
Where a single line containing a number of genes has been produced as a result of direct gene technology methods (rather than traditional crossing) then food derived from the line must undergo a full pre-market safety assessment before approval can be given Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)
| Name of product applicant: |
Monsanto do Brasil Ltda |
| Summary of application: |
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| Date of authorization: |
05/11/2020 |
| 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.): |
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| Summary of the safety assessment (food safety): |
The biosafety assessment of genetically modified corn resistant to insects, event MON 95379, concludes on its similarity to conventional maize in terms of biosafety to the environment and human and animal health. In the evaluation, CTNBio considered the opinions issued by the members of the Commission; documents submitted to the CTNBio Executive Secretariat by the applicant; results of planned releases to the environment and related texts. Studies and scientific publications independent of the applicant and carried out by third parties were also considered and consulted. |
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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: |
Molecular traddicional methods. |
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| Authorization expiration date (a blank field means there is no expiration date) |
not applicable |
E-mail:
Organization/agency name (Full name): National Biosafety Technical Commission
Contact person name: Paulo Augusto Viana Barroso
Website:
Physical full address: SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number: 556120335087
Fax number:
Country introduction: Brazil had the first biosafety law approved in 1995. After the identification of the need to improve the biosafety system of Brazilian genetically modified organisms, a new law was published. The Law 11.105 / 05 establishes a technical committee dedicated to the analysis of the safety aspects of genetically modified organisms and a council of ministers that is dedicated to the analysis of the socioeconomic aspects of the commercial release of genetically modified organisms. In this context, Brazil already has several commercial products that involve genetically modified organisms (plants, human and veterinary vaccines, microorganisms for fuel production) and products derived from new genetic modification techniques. Useful links
Relevant documents
Stacked events: At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Dr. Paulo Augusto Viana Barroso (President of national Biosafety Commission)
| Name of product applicant: |
Bayer CropScience Ltd. |
| Summary of application: |
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| Date of authorization: |
19/01/2022 |
| 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.): |
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| Summary of the safety assessment (food safety): |
The FSCJ concluded that no concern relavant to human health is raised on the MON95379 line |
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E-mail:
Organization/agency name (Full name): Food Safety Commission Secretariat,Cabinet Office,
Contact person name: Kojiro Yokonuma
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:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
Bayer Co. (Malaysia) Sdn. Bhd. |
| Summary of application: |
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| Date of authorization: |
02/11/2023 |
| 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
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| Summary of the safety assessment (food safety): |
Please refer to the Risk Assessment Report. |
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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 Natural Resources, Environment and Climate Change
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, Ministry of Natural Resources, Environment and Climate Change Level 4, Block F11, Complex F Lebuh Perdana Timur, Precinct 1 62000 Putrajaya, Malaysia. 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]
| Name of product applicant: |
Monsanto Philippines, Inc. |
| Summary of application: |
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| Date of authorization: |
22/03/2022 |
| 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.): |
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| Summary of the safety assessment (food safety): |
Toxicological and Allergenicity Assessment:
Bt-produced Cry1B.868 and Cry1Da_7 proteins were used for the safety assessment. The Bt-produced proteins are structurally and functionally equivalent to the plant-produced proteins present in corn MON 95379 based on the N-terminal sequence analysis, peptide mass mapping, functional activity assay, Western blot analysis and glycosylation analysis.[24][25].
It was observed that both Cry1B.868 and Cry1Da_7 at 75°C and above lost its functional activity to >98% with respect to the control heated at 15 and 30 minutes. The SDS-PAGE also showed the visible evidence of fading bands indicating the denaturation.[21]
Bioinformatics analysis and tools confirmed that Cry1B.868 and Cry1Da_7 proteins have no significant homology with any known toxins and allergens.[26].
Assessment of toxicity through acute oral gavage in mice resulted to NOAEL at 5000 mg/kg bw, no treatment related effects on survival, clinical observation, body weight gain, food consumption or gross pathology was observed.[25].
It was observed that the Cry proteins were present in all plant tissue and are highest in the grains of the plant. The percentage of Cry1B.868 in the grains is 0.0271% or 271 ppm and for Cry1Da_7 is 0.00026% or 2.6 ppm of the total grain protein.[27].
Nutritional Data:
Grain and forage compositional analyses of samples from corn MON 95379 demonstrated statistical differences in terms of protein and carbohydrates. The difference noted is within the range of the literature values and ILSI database and can be attributed to the natural variation within the conventional control grown at multiple locations.[8].
Nine amino acids found in corn grains namely: alanine, glutamic acid, isoleucine, leucine, methionine, phenylalanine, serine, threonine, and valine, were found significantly different from the conventional control. However, the difference is not biologically relevant since all values are within the range of literature value.[8]
Safety assessment based on the nutritional data indicates that there is no significant difference between the proximate, fiber, amino acid, fatty acid, mineral, and vitamin levels of corn MON 95379 and conventional corn that can be considered biologically relevant.[8]. |
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E-mail:
Organization/agency name (Full name): Bureau of Plant Industry
Contact person name: Geronima P. Eusebio
Website:
Physical full address: San Andres St., Malate, Manila
Phone number: 632 404 0409 loc 203
Fax number:
Country introduction: In 1987, scientists from the University of the Philippines Los Banos (UPLB) and the 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), recognizing the potential harm of the introduction of exotic species and genetic engineering, formed a committee and formulated the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. The committee went on to draft a Philippine biosafety policy, which was submitted to the Office of the President. On October 15, 1990, recognizing the potential for modern biotechnology both in improving the lives of the people and in creating hazards if not handled properly, President Corazon C. Aquino issued Executive Order 430 creating the National Committee on Biosafety of the Philippines (NCBP) that will formulate, review and amend national policy on biosafety and formulate guidelines on the conduct of activities on genetic engineering. The NCBP is comprised of representative of the Departments of Agriculture (DA); Environment and Natural Resources (DENR); Health (DOH); and Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science; and 2 respected members of the community. On July 16, 2001, President Gloria Macapagal-Arroyo issued the Policy Statement on Modern Biotechnology, reiterating the government policy on promoting the safe and responsible use of modern biotechnology. On April 3, 2002, Department of Agriculture Administrative Order No. 8, Series of 2002 was issued implementing the guidelines for importation and release into the environment of Plants and Plant Products Derived from the Use of Modern Biotechnology. On March 17, 2006, President Gloria Macapagal-Arroyo issued Executive Order No.514 Establishing the National Biosafety Framework, prescribing guidelines for its implementation, reorganizing the National Committee on Biosafety of the Philippines, and for other purposes. On December 8, 2015, the Philippine Supreme Court declared DA AO8 null and void and any application for contained use, field testing, propagation and commercialization, and importation of GMOs was temporarily enjoined. In response to the nullification of DA AO8, the Technical Working Group composed of representatives from the Departments of Agriculture (DA), Science and Technology (DOST), Environment and Natural Resources (DENR), Health (DOH), and Interior and Local Government (DILG) drafted the Joint Department Circular No. 1, Series of 2016 (JDC No.1, S2016) titled 'Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically-Modified Plant and Plant Products Derived from the Use of Modern Biotechnology'. There were series of meeting and five public consultations conducted before the JDC No.1, S2016 was approved and signed by the Secretaries of the abovementioned agencies on March 7, 2016 and took effect on April 15, 2016. Under this Circular, more government agencies were involved such as the Department of Science and Technology (DOST) to regulate applications for contained use and confined test of regulated articles; Department of Agriculture (DA) to evaluate applications for field trial, commercial propagation and transboundary movement of regulated articles; Department of Environment and Natural Resources (DENR) to evaluate environmental risks and impacts of regulated articles; Department of Health (DOH) to evaluate of environmental health impacts of regulated articles; and Department of the Interior and Local Government (DILG) to supervise public consultation during field trial.
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.
Plant Products Carrying Stacked Genes Conferred Through (a) Genetic Engineering or b) Conventional Breeding, with Individual Traits That Have No Prior Approval:
A full risk assessnent as to food and feed or processing shall be conducted,consistent with Part V of AO No. 8,"Approval Process For the Importation of Regulated Articles for Direct Use as Food and Feed or For Processing for plant products with multiple traits conferred through:
(a) genetic engineering, or
(b) conventional breeding, where the individual traits have no prior approval from the Bureau of Plant Industry (BPI) for direct use as food and feed or processing.
Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:
For plant products with multiple traits conferred through conventional breeding,with all individual events granted prior approval and included in the Approval Registry, a notlfication shall be submitted by the technology developer to the BPI, which shall conduct an evaluation in accordance with the relevant criteria in Annex I of this Memorandum Circular. The list of data contained in Annex I will not preclude the inclusion of other issues and concerns that will be raised by the BPI and the Scientific and Technical Review Panel (STRP) during the course of the desktop review.
Notificatlon Requirement for Plant Products Carrying Stacked Genes
All technology developers shall submit a notification to the Bureau of Plant Industry of their developed plant products carrying stacked genes and shall be required to comply with the relevant approval process listed above.
The Bureau of Plant Industry shall issue a certiflcate as to the approval of the stacked gene product and shall likewise include the transformation event in the official approval registry of plant products for food and feed or processing. 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
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