Food safety and quality
| share
 

OECD Unique Identifier details

SYN-E3272-5 x SYN-BTØ11-1 x SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 x SYN-Ø53Ø7-1 x MON-ØØØ21-9
Commodity: Corn / Maize
Traits: Insect resistance,Thermostable alpha-amylase production,Glyphosate tolerance,Lepidoptera resistance,Coleoptera resistance,Glufosinate tolerance
Colombia
Name of product applicant: SYNGENTA
Summary of application:

Authorization of the genetically modified maize 3272 x Bt11 x MIR604 x TC1507 x 5307 x GA21 resistant to lepidoptera and coleoptera and coleoptera pest attack, tolerant to herbicides glyphosate and glufosinate, and modified the quantity of bioetanol

Upload:
Date of authorization: 09/02/2017
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):
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.
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
drubio@minsalud.gov.co
Organization/agency name (Full name):
Ministerio de salud y proteccion social
Contact person name:
Daniel Rubio
Website:
Physical full address:
Carrera 13 No. 32- 76 piso 12, Bogotá
Phone number:
330 5000 ext 1256
Fax number:
Country introduction:

The 4525 decree of 2005, established the Ministry of Health and Social Protection as the competent authority for GMO for health and food purposes and creates the National Biosafety Technical Committee for GMO's used in health and food purposes (CTNSalud).

The CTNSalud is composed by the Ministry of Health and Social Protection, the National Food and Drug Surveillance Institute (INVIMA) and the Technology and Innovation Administrative Department (COLCIENCIAS). This committee is responsible for the assesment of risk assessments; to inquire for any additional information; assessment of any measurements in accordance to the Cartagena Protocol; and the recommendation for the authorization of GMO for health or food purposes.

Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Mexico
Name of product applicant: Syngenta Agro, S.A de C.V
Summary of application:

Authorization by COFEPRIS: 148



Corn (Zea mays) genetically modified (3272x Bt11 x MIR604 x TC1507 x 5307x GA21) resistant to Lepidoptera and Coleoptera, tolerant to glyphosate and glufosinate ammonium herbicides and with an alpha-amylase protein that catalyzes the hydrolysis of starch to soluble sugars.

Upload:
Date of authorization: 23/07/2015
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 (food safety):
No toxic, allergic or substantial nutritional changes were observed. Therefore it can be ensured that the genetically modified corn (Zea mays) OECD identifier: SYN-E3272 X SYN-BTØ11-1 X SYNIR6Ø4-5 X DAS-Ø15Ø7-1 X SYN-Ø53Ø7-1 X MON-ØØØ21-9 is, based on the existing knowledge to date, as innocuous as its conventional counterpart.
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
sortiz@conacyt.mx
Organization/agency name (Full name):
CIBIOGEM
Contact person name:
Dra. Sol Ortiz García
Website:
Physical full address:
San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number:
+52 (55) 5575-6878
Fax number:
Country introduction:

México ha buscado garantizar la inocuidad de los productos biotecnológicos para el uso y consumo de su población. Desde 1984 el artículo 282 bis 1 de la Ley General de Salud, contempló que la Secretaría de Salud debería regular aquellos productos biotecnológicos, o sus derivados, destinados al uso o consumo humano. En un inicio, con fundamento en este artículo, la Secretaria de Salud evaluó la inocuidad alimentaria de productos biotecnológicos, para su comercialización con fines de uso o consumo humano. A partir de 2005, con la entrada en vigor de la Ley de Bioseguridad de Organismos Genéticamente Modificados (LBOGM), se realizó la adecuación de la regulación para dar lugar a la Autorización que es el acto administrativo mediante el cual la Secretaría de Salud, a través de la Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), autoriza Organismos Genéticamente Modificados (OGMs), a efecto de que se pueda realizar su comercialización, así como su utilización con finalidades de Salud Pública o de Biorremediación.

Las facultades que corresponden a la Secretaría de Salud se estipulan en el artículo 16 de la LBOGM y lo relativo a la Autorizaciones se describe en los artículos 91 al 98 de dicha Ley. Quienes pretendan obtener una Autorización para Comercialización e Importación de OGMs deben presentar ante COFEPRIS, una solicitud por escrito acompañada de la información a que se refiere los artículos 23 al 32 del Reglamento de la Ley de Bioseguridad de OGMs.

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf

 

Courtesy translation

Mexico has sought to guarantee the safety of biotechnological products the use and consumption of its population. Since 1984, article 282 bis 1 from the General Law of Health, considered that the Secretary of Health should regulate those biotechnological products, or their derivatives, intended for food and feed use. Initially, the Secretary of Health evaluated the food safety of biotechnological products, based on this article, for commercialization with purposes of food, feed and processing. Subsequently in 2005, with the entry into force of the Law on Biosafety of Genetically Modified Organisms (LBOGM), the regulation was adapted to give rise to the Authorization, which is the administrative act through which the Secretary of Health, by means of the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), authorizes Genetically Modified Organisms (GMOs), to their commercialization, as well as their use for purposes of public health or bioremediation.

The faculties that correspond to the Secretary of Health are stipulated in Article 16 of the LBOGM and what is related to the Authorizations is described in Articles 91 to 98 of this Law. Those who seek to obtain an Authorization for GMOs merchandising and importation, must present to COFEPRIS, a written request accompanied by the information referred into articles 23 to 32 of the Regulation of the Law on Biosafety of Genetically Modified Organisms.

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf

Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Secretaría de Salud / Phone: +52 55 5080 5200 /Email: ralatorre@cofepris.gob.mx%20

Philippines
Name of product applicant: Syngenta Philippines Inc.
Summary of application:

On December 16, 2016, Syngenta Philippines Inc. applied the stacked trait product corn 3272 x Bt11 x MIR604 x TC1507 x 5307 x GA21 for direct use as food and feed, or for processing as an original application under the DOST-DA-DENR-DOH-DILG Joint Department Circular No. 1 Series of 2016 (JDC No.1, S2016). After reviewing the Risk Assessment Report and attachments submitted by the applicant; the Scientific and Technical Review Panel (STRP) member, BPI-Plant Products Safety Services Division (BPI-PPSSD) and Bureau of Animal Industry (BAI) has found no interaction of the resulting gene product of the regulated article applied for direct use as food and feed, or processing based on scientific evidences provided. The STRP, BAI, and BPI-PPSSD concurred that the likelihood of interaction of the proteins involved in the combined trait product: Amy797E in 3272, Cry1Ab in Bt11 , mCry3A in MIR604, Cry1F in TC1507, eCry3.1Ab in 5307, mEPSPS is highly unlikely to produce any known allergen or toxins to human and animals because of the difference on their mode of action. There is no known mechanism of interaction among the RNA-based suppression and the proteins that could lead to adverse effects in human, animals or environment which is not likely to interact. Furthermore, the assessors affirmed that there are no possible unintended effects of stacked genes on the metabolism of the plant based on the previous assessments of individual transformation events. In addition, stability and expression of the gene will never be affected since molecular analyses also indicated the absence of any marker gene in 3272 x Bt11 x MIR604 x TC1507 x 5307 x GA21 genome. After thorough scientific review and evaluation of Syngenta’s duly accomplished Environmental Risk Assessment (ERA) and Project Description Report (PDR) forms, the Department of Environment and Natural Resources – Biosafety Committee (DENR-BC), recommended for the issuance of a biosafety permit for this regulated event provided that the conditions set by DENR are complied. Also, the Department of Health – Biosafety Committee (DOH-BC), after a thorough scientific review and evaluation of the accomplished Environmental Health Risk Assessment form, concluded that corn 3272 x Bt11 x MIR604 x TC1507 x 5307 x GA21 will not pose any significant risk to the health and environment and that any hazards could be managed by the measures set by the department. Hence, the DOH-BC also recommended for the issuance of biosafety permit for the stacked trait product. Lastly, after assessing that there will be no negative socio-economic, ethical and cultural concerns that will arise from the adoption of Genetically Modified Organisms, the Socioeconomic, Ethical and Cultural (SEC) expert recommended for the approval and issuance of biosafety permit of corn 3272 x Bt11 x MIR604 x TC1507 x 5307 x GA21 for direct use as food and feed, or for processing

Upload:
Date of authorization: 25/06/2018
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 (food safety):
STRP, BAI, PPSSD ASSESSMENT 3272 x Bt11 x MIR604 x TC1507 x 5307 x GA21 is a glyphosate and dicamba herbicide tolerant soybean developed by Syngenta Company through conventional breeding techniques from the single event products 3272, Bt11, MIR604, TC1507, 5307 and GA21. The safety of each single event, 3272, Bt11, MIR604, TC1507, 5307 and GA21 has recently been assessed and approved for direct use for food and feed, or for processing (FFP) by the Bureau of Plant Industry in 2013, 2013, 2012, 2013, 2015 and 2013, respectively. Gene Interaction Based on the documents provided by the developer, the STRP, BAI and PPSSD agreed that the eight (8) proteins being expressed in the combined trait product, DMO and CP4 EPSPS, will not produce new or identified allergen or toxin because they are unlikely to interact due to the different mode of action of each protein. Amy797E in 3272, Cry1Ab in Bt11 , mCry3A in MIR604, Cry1F in TC1507, eCry3.1Ab in 5307, mEPSPS in GA21, PAT in Bt11 and TC1507, and PMI in 3272, MIR604 and 5307 were assessed using different comprehensive bioinformatics analyses and showed that these proteins have no significant homology and similarity to any known allergen and toxins that could lead to potential adverse effect on human and animal health. There proteins are also unlikely to accumulate in the same subcellular components of the corn genome. For Bt11, the cry1Ab and pat gene expressions are both driven by the 35S promoter, for 3272, the amy797E gene expression is driven by maize gamma-zein (GZein) promoter. This promoter provides endosperm-specific expression in Zea mays. The gene includes 19 amino acid N-terminal maize gamma-zein signal sequence (GZein ss) and a C-terminal SEKDEL endoplasmic reticulum retention signal (ER rs) and pmi expressions of 3272 is driven by ZmUbilnt promoter. For MIR604, the mcry3A gene expression is driven by the MTL promoter, MIR604 pmi gene expression is driven by the ZmUbi, for TC1507, the cry1F and pat gene expression are driven by the maize Ubi1ZM and 35S promoters, respectively and for 5307, ecry3.1Ab expression is driven by CMP promoter and 5307 pmi is driven by ZmUbilnt promoter and are intended to accumulate at the cytoplasm because no cellular localization sequences are present. Modified EPSPS enzyme in GA21 or otherwise, is known to accumulate in the chloroplast. A chloroplast transit peptide that directs the protein to the chloroplast is included in the gene that codes for mEPSPS. The transit peptide is cleaved off of the protein when it is transferred into the chloroplast. The assessors also agreed that the indication that all proteins have been immediately imported to the chloroplast upon synthesis is when the protein is isolated from the plant, only the cleaved version of the protein will be found. Metabolic Pathways The mode of action and metabolic pathways of each protein are significantly different from each other. The protein, amy797E was derived from alpha-amylase genes from three (3) hyperthermophilic microorganism of the archael order Thermococcales. Alpha amylase catalyzes hydrolysis of starch by cleaving the internal α-1,4-glucosidic bonds into dextrins, maltose and glucose. Cry proteins selectively binds to a specific sites localized in the midgut cells of susceptible insects which leads disruption of midgut ion flow or swelling of cells and eventually death of insect. Cry1 proteins are known to cause toxicity against certain Lepidopteran insects while Cry3 protein are known to be specific against Coleopteran insects. Modified EPSPS is involved in the shikimic pathway of aromatic amino acid biosynthesis Phosphinothricin-N-acetyl transferase detoxifies glufosinate ammonium through acetylation of phosphinothricin to N-acetyl-glufosinate, 3-methylphosphinicopropionic acid (MPP) and 3-methylphosphinicoacetic acid (MPA). PMI convert mannose to fructose-6-phosphate improving energy status of the cells and preventing accumulation of derivatized mannose. It was being used as selectable marker employed only during selection of transformed cells in culture. Gene Expression The concentrations of Cry1Ab, Amy797E, mCry3A, Cry1F, eCry3.1Ab and mEPSPS proteins in tissues of the stacked-trait 3272 x Bt11 x MIR604 x TC1507 x 5307 x GA21 maize hybrid were similar to those of the corresponding single event maize hybrids 3272, Bt11, MIR604, TC1507, 5307, and GA21. These concentrations were determined and quantified using ELISA. As expected, PAT concentrations in tissues of the stacked-trait were higher than those from each of the component single event hybrid due to the presence of 2 copies of the pat gene in the stacked-trait hybrid, while Bt11, MIR604 and TC1507 maize hybrids each contain 1 copy of the pat gene. Southern Blot Analysis showed that the marker genes, pat and pmi, are transferred and expressed in 3272 x Bt11 x MIR604 x TC1507 x 5307 x GA21 stack. History of safe use was attributed with pat and pmi genes. Comprehensive bioinformatics analyses showed that these proteins have no significant homology and similarity to any known allergen and toxins that could lead to potential adverse effect on human and animal health. Since the hybridization bands detected were of the expected sizes, this demonstrated that 3272 x Bt11 x MIR604 x TC1507 x GA21 corn contains 1 copy per genome of pmi from 3272 corn, 1 copy per genome of pmi from MIR604, and 1 copy per genome of pmi from 5307 corn, as expected. The DNA hybridization patterns for 3272 x Bt11 x MIR604 x TC1507 x GA21 corn corresponded to the hybridization bands observed for 3272, MIR604, and 5307 corn, with all the restriction digestion enzymes used. Conclusion After a thorough and scientific evaluation of the documents provided by Syngenta Philippines Inc. and other related literature, scientific evidence indicates that the stacked genes of soybean 3272 x Bt11 x MIR604 x TC1507 x 5307 x GA21 applied for direct use as food and feed or for processing has no evidence of interaction on the resulting gene products and as safe as its conventional counterpart.
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date) June 24, 2023
E-mail:
bpibiotechsecretariat@gmail.com
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

Republic of Korea
Name of product applicant: Syngenta Korea
Summary of application:

Glufosinate herbicide tolerance, Glyphosate herbicide tolerance, Coleopteran insect resistance ,            Lepidopteran insect resistance , Multiple insect resistance , Modified alpha amylase

Upload:
Date of authorization: 27/10/2014
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 (food safety):
Please see the link below(in Korean).
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
mytrue85@korea.kr
Organization/agency name (Full name):
Ministry of Food and Drug Safety
Contact person name:
Website:
Physical full address:
Osong Health Technology Administration Complex, 187, Osongsaengmyeong 2-ro, Osong-eup, Cheongwon-gun, Chungcheonbuk-do, 363-700, Korea
Phone number:
82-43-719-2360
Fax number:
Country introduction:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: