Food safety and quality
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OECD Unique Identifier details

SYN-BTØ11-1xSYN-IR162-4xSYN-IR6Ø4-5xMON-ØØØ21-9
Commodity: Corn / Maize
Traits: Coleoptera resistance,Glufosinate tolerance,Glyphosate tolerance,Lepidoptera resistance
Argentina
Name of product applicant: Syngenta Agro S.A.
Summary of application:
The stacked event Bt11xMIR162xMIR604xGA21 of maize confers resistant to certain lepidopteran and coleopteran insects, tolerance to herbicides which active principle is glyphosate and glufosinate ammonium. The single events were stacked by conventional crossing (sexual). The stacked event has two genes, mcry3A and pmi, from MIR604 event, two genes, vip3Aa20 and pmi, from MIR162 event, two genes, cry1Ab and pat, from Bt11 event and mepsps gene from GA21 event. The transgenes are inherited independently, since they presents mendelian segregation. Moreover, the applicant proved the gene stability and the effective levels of the expressed proteins. The protein mCry3A confer resistance to coleopteran insects (principal species of the genus Diabrotica) and the proteins Cry1Ab and Vip3Aa20 confers resistance to lepidopteran insects (some affected species are Spodoptera frugiperda, Helicoverpa zea and Diatraea saccharalis). The protein mEPSPS has similar structure and is functionally identical to the endogenous EPSPS enzyme of the plants, but with a reduced affinity to glyphosate. The enzyme phosphinothricin N-acetyltransferase (PAT) eliminates herbicidal activity of glufosinate (phosphinothricin) by acetylation. The enzyme phosphomannose isomerase (PMI) acts as a selectable marker allowing the use of mannose as a carbon source. After comparison of 65 analytes measured in grain and forage, in the compositional analysis study, it's concluded that maize with the stacked event Bt11xMIR162xMIR604xGA21 is equivalent to the commercial maize and parental lines. The allergenicity and toxicity assessment of proteins of new expression were carried out previously in the singles events. A 49 day study, carried out in 540 broiler chicken, demonstrate that no adverse dietary effects on chickens that consumed the stacked maize grain in the diets. 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. The Bt11xMIR162xMIR604xGA21 event is substantial and nutritionally equivalent to its non transgenic counterpart.
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Date of authorization: 07/02/2012
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 Bt11xMIR162xMIR604xGA21
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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: Syngenta Seeds K.K.
Summary of application:

Bt11 x MIR162 x MIR 604 x GA21 has been genetically modified for resistant to Lepidoptera and Coleoptera, and tolerant to glufosinate and glyphosate herbicides (modified cry1Ab,
modified vip3A, modified cry3Aa2, pat, mEPSPS, Zea mays subsp. mays (L. ) Iltis).

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Date of authorization: 08/03/2010
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 see 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:
Hirotoshi Maehara
Website:
Physical full address:
Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number:
81 3 6234 1074
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)
Mexico
Name of product applicant: Syngenta Agro, S.A. de C.V.
Summary of application:

Maíz (Zea mays) resistente a insectos Lepidópteros, Coleópteros, y con tolerancia a los herbicidas glufosinato de amonio y glifosato. Bt11XMIR162XMIR604XGA21.


 


Identificador OECD: SYN-BTÆ11-1 X SYN-IR162-4 X SYN-IR6Ø4-5 X MON-ÆÆÆ21-9


Información presentada (la documentación deberá presentarse en español y podrá estar contenida en archivo electrónico):






































1) Descripción de aplicaciones o usos propuestos del   alimento modificado



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2) Información concerniente a fuente, identidad y   función del material genético introducido, incluyendo pruebas de estabilidad



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3) Información sobre la descripción de la   modificación genética y su caracterización (descripción del método de   transformación genética, caracterización y descripción de los materiales   genéticos insertados)



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4) Información concerniente a la identidad y función   de la expresión de los productos modificados, incluyendo un estimado de la   concentración de la modificación en el cultivo modificado o su alimento   derivado



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5) Información concerniente a cualquier   alergenicidad esperada o conocida de la expresión del producto y el   fundamento para concluir que el alimento que la contiene pueda ser consumido   con seguridad



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6) Información comparando la composición o   características de los alimentos modificados con los alimentos derivados de   la variedad original u otras variedades comúnmente consumidas, con particular   énfasis sobre los nutrientes importantes y tóxicos que de manera natural   puedan presentarse en el alimento



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7) Información adicional (relevante para la   seguridad y evaluación nutricional del alimento modificado)



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8) Autorizaciones emitidas por otros países del   producto para consumo humano (copia)



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Usos propuestos:









Para ser procesado y usado en los alimentos de   consumo humano y animal, forraje y productos industriales en la misma forma   como los productos obtenidos con el maíz convencional.



 


Descripción del producto de transformación:









El   híbrido de maíz con combinación de genes Bt11 x MIR162 x MIR604 x GA21 es   producto de cruza convencional de los siguientes híbridos modificados   genéticamente:


1.-Bt11   (OECD: SYN-BTØ11-1) que expresa la proteína Cry1Ab de Bacillus thuringiensis var.   kurstaki HD-1, para el control de ciertas plagas de lepidópteros y una   fosfinotricina acetiltransferasa (PAT) de Streptomyces   viridochromogenes que confiere tolerancia al herbicida glufosinato.


2.-MIR162   (OECD: SYN-IR162-4), expresa la proteína Vip3Aa20 sintética para el control   de ciertas plagas de Lepidópteros y una fosfomanosa isomerasa (PMI) de Escherichia coli cepa K-12 que actúa   como marcador de selección auxotrófico.


3.-MIR604   (OECD: SYN-IR604-5) expresa una proteína Cry3A modificada de Bacillus thuringiensis subsp. tenebrionis   ó mCry3A, que actúa contra algunas plagas de coleópteros y una PMI de Escherichia coli cepa K-12, como   marcador de selección.


4.-GA21   (OECD: MON-ØØØ21-9), expresa la proteína 5-enol-piruvilshikimato-3-fosfato   sintasa de maíz (Zea mays)   modificada (mEPSPS) que le confiere tolerancia a glifosato.



 

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Date of authorization: 04/08/2010
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:
Evaluación de la inocuidad: Alergenicidad: Los ensayos de digestión simulada y de estabilidad al calor, así como la comparación informática con alérgenos conocidos, demostraron que la probabilidad de alergenicidad de las proteínas insertadas es baja. Toxicidad: Los estudios de toxicidad aguda y subcrónica, así como la comparación informática con toxinas conocidas, demostraron que la toxicidad de las proteínas insertadas es baja. Nutricional: Los resultados de composición para el maíz SYN-BT11-1 X SYN-IR162-4 X SYN-IR6Ø4-5 X MON-21-9 confirman la equivalencia sustancial entre el maíz genéticamente modificado y el maíz convencional utilizado como control. Autorizaciones del producto para consumo humano emitidas por otros países: El evento Bt11 ha sido aprobado desde 1996 por varios países entre los que se pueden mencionar: Canadá, que lo autorizó para consumo humano (1996) y animal (1996); Japón liberación al ambiente (1996), consumo humano (1996) y animal (1996); E.U.A. Liberación al ambiente (1996) y consumo humano y/o animal (1996); Unión Europea Consumo humano (1998) y consumo animal (1998); Suiza para consumo humano (1998) y animal (1998); Argentina para consumo humano (2001) y animal (2001), Filipinas para consumo humano (2003) y animal (2003), liberación al ambiente (2005); Sudáfrica para consumo humano y/o animal (2002), liberación al ambiente (2003); Uruguay para liberación al ambiente (2004), consumo humano y/o animal (2004); México para consumo humano y/o animal (2007); Colombia para consumo humano (2008) y consumo animal (2008). El evento MIR162 ha sido aprobado en los siguientes países: E.U.A. para consumo humano y/o animal (2008), liberación animal (2010); Australia para consumo humano (2009); Brasil para liberación al ambiente (2009), consumo humano y/o animal (2009); Taiwán para consumo humano (2009); Rusia para consumo humano (2010); Canadá para liberación del ambiente (2010), consumo humano (2010) y animal (2010); Japón para consumo humano (2010); México para consumo humano y/o animal (2010); Filipinas para consumo humano (2010) y animal (2010). El evento MIR604 se ha aprobado en los países siguientes: Australia para consumo humano (2006); Canadá para la liberación al ambiente (2007), consumo humano (2007), consumo animal (2007); Japón para la liberación al ambiente (2007), consumo humano (2007) y animal (2007); México para consumo humano y/o animal (2007); Filipinas para consumo humano y/o animal (2007); Rusia para consumo humano (2007) y animal (2008); Corea para consumo humano (2007) y animal (2008); Taiwán para consumo humano (2007); E.U.A. para la liberación al ambiente (2007), consumo humano y/o animal (2007). El evento GA21: Aprobado en E.U.A. para consumo humano y/o animal (1996), liberación al ambiente (1997); en Canadá aprobado para liberación al ambiente (1998), consumo humano (1999) y animal (1998); en Argentina se aprobó para liberación al ambiente (1998), para consumo humano y/o animal (2005); Australia aprobado para consumo humano (2000); aprobado en Japón para liberación al ambiente (1998), consumo humano (1999) y animal (1999); aprobado en Corea para consumo humano (2002) y animal (2005); aprobado en México para consumo humano y/o animal (2002); aprobado en Sudáfrica para consumo humano y/o animal (2002); aprobado en China para consumo humano y/o animal (2004); Unión Europea para consumo humano (2006) y animal (2005); aprobado en Brasil para la liberación al ambiente (2008), consumo humano y/o animal (2008); aprobado en Filipinas para liberación al ambiente (2009), consumo humano (2003) y animal (2003). Conclusión: No se observaron efectos tóxicos, alérgicos o cambios nutrimentales sustanciales en el maíz genéticamente modificado evento SYN-BT11-1 X SYN-IR162-4 X SYN-IR6Ø4-5 X MON-21-9 Por lo tanto puede asegurarse que el evento es, con base en los conocimientos existentes hasta la fecha, tan inocuo como su homólogo convencional.
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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:
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:

La Comisión Intersecretarial de Bioseguridad de los Organismos Genéticamente Modificados está integrada por los titulares de las Secretarías de Medio Ambiente y Recursos Naturales Renovables (SEMARNAT), Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación (SAGARPA); Salud (SS); Hacienda y Crédito Público (SHCP); Economía (SE) y Educación Pública (SEP); así como por el Director General del Consejo Nacional de Ciencia y Tecnología (CONACYT).

La presidencia de la Comisión es rotatoria por periodos de dos años, entre los Secretarios de Salud, SAGARPA y SEMARNAT ya que son las Secretarías con un mayor ámbito de competencia en relación con el uso seguro de los Organismos Genéticamente Modificados (OGMs).

Ley de Bioseguridad de Organismos Genéticamente Modificados, estipula que para su implementación la Comisión debe coordinar las acciones pertinentes con las instancias del Gobierno para cumplir su objetivo.

La CIBIOGEM, cuenta con grupos de apoyo que son sus órganos técnicos y consultivos: Comité Técnico, Consejo Consultivo Científico, Consejo Consultivo Mixto y la Secretaría Ejecutiva.

¿Cuál es el propósito de la CIBIOGEM?

Coordinar las políticas de la administración pública federal referentes a diferentes actividades relacionadas con OGMs como son: la producción, importación, exportación, movilización, transporte, siembra, consumo y, en general uso y aprovechamiento de OGMs.

 

-Courtesy Translation-

The Intersecretarial Commission on Biosafety of Genetically Modified Organisms is made up of the heads of the Secreataries of Health (SSA); Agriculture, Livestock, Rural, Development, Fisheries and Food (SAGARPA); Environment and Natural Resources (SEMARNAT); Finance and Public Credit (SHCP); Economy (SE); Public Education, and the General Director of the National Council of Science and Technology.

The chair of the Commission rotates every two years among the Secretaries of Health, SEMARNAT and SAGARPA, the three entities most directly involved in policies concerning the use and biosafety of Genetically Modified Organisms (GMOs).

The Law on Biosafety of Genetically Modified Organisms states that the Commission aims to promote and coordinate the actions of Government agencies. CIBIOGEM receives support from the Executive Secretariat of CIBIOGEM, the Technical Committee, the Scientific Advisory Board and the Joint Advisory Council.

What is the purpose of the CIBIOGEM?

To coordinate the policies and federal regulation of activities related to Genetically Modified Organisms (GMOs) such as: production, import, export, mobilization, transportation, release into the environment, consumption, and general use of GMOs.

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: marriola@cofepris.gob.mx
Philippines
Name of product applicant: Syngenta Philippines
Summary of application:
Corn Bt11 x MIR162 x MIR604 x GA21 is a stacked hybrid developed by crossing Event Bt11, Event MIR162, Event MIR604 and Event GA21 using conventional breeding techniques.
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Date of authorization: 10/12/2010
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.):
Summary of the safety assessment:
Syngenta Philippines had 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 Administrative Order (AO) No. 8 Part 5 for stacked trait product corn: Bt11 x MIR162 x MIR 604 x GA21 which has been genetically modified for insect resistance and herbicide tolerance. A safety assessment of combined trait product corn: Bt11 x MIR162 x MIR 604 x GA21 was conducted as per Department of Agriculture 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/among the transgenes.
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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:
Upload:
Authorization expiration date:
E-mail:
bpibiotechsecretariat@yahoo.com
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Merle B. Palacpac
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