Food safety and quality
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OECD Unique Identifier details

SYN-Ø53Ø7-1
Commodity: Corn / Maize
Traits: Coleoptera resistance
Australia
Name of product applicant: Syngenta Seeds Pty Ltd
Summary of application:
Insect-protected corn line 5307, a product of Syngenta Seeds Pty Ltd, is a genetically
modified (GM) corn that is protected from feeding damage caused by the larvae of a number of insect pest species. Protection is conferred by expression in the plant of a chimeric insecticidal protein derived from two naturally occurring crystal (Cry) proteins found in Bacillus thuringiensis (Bt), a common soil bacterium. The Cry proteins exert their effect by causing lysis of midgut epithelial cells, which leads to gut paralysis, cessation of feeding and eventual death of the insect larvae. The lysis of the epithelial cells is mediated by the binding of the activated Cry protein to specialised receptors on the cells of the insect midgut.
The gene introduced into corn line 5307, ecry3.1Ab, encodes a chimeric protein engineered from selected portions of the modified Cry3A (mCry3A) and Cry1Ab proteins. The chimeric eCry3.1Ab protein is insecticidally active against the larvae of Western corn rootworm (Diabrotica virgifera virgifera Le Conte), Northern corn rootworm (D. Longicornis barberi Smith and Lawrence) and Mexican corn rootworm (D. Virgifera zeae Krysan and Smith). These coleopteran species cause significant damage to corn crops grown in North American regions.
Corn line 5307 also contains the bacterial pmi gene, also known as manA, which is derived from Escherichia coli strain K-12. Expression of the PMI protein in plants allows growth on mannose as a carbon source. This was used as a selectable marker to assist with identification of transformed corn cells in the early stages of plant development.
Corn is not a major crop in Australia or New Zealand. Corn line 5307 is intended for use mainly in conventional plant breeding programs to generate agricultural products suitable for commercial cultivation in the United States and Canada, and is not intended for cultivation in Australia or New Zealand. If approved, food from this line may enter the Australian and New Zealand food supply as imported food products.
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Date of authorization: 26/04/2012
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:
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: Application A1060 - Food derived from Insect-protected Corn Line 5307
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Authorization expiration date:
E-mail:
janet.gorst@foodstandards.gov.au
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Janet Gorst
Website:
Physical full address:
Boeing Building, 55 Blackall Street, Barton ACT 2600, Australia
Phone number:
+61 2 6271 2266
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 120 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 15 staff) is located in Wellington on the North Island. The Food Standards Australia New Zealand Act 1991 establishes the mechanisms for the development and variation of joint food regulatory measures and creates FSANZ as the agency responsible for the development and maintenance of a joint Australia New Zealand Food Standards Code (the Code). The Code is read in conjunction with corresponding NZ and State & Territory food legislation as well as other appropriate legislative requirements (e.g. Trade Practices; Fair Trading). Within the Code, Standard 1.5.2 deals with Foods produced using Gene Technology. Applicants seeking to have a GM food approved, request a variation to Std 1.5.2 to have the GM food (from a particular line) included in the Schedule to Std 1.5.2. Only those GM foods listed in the Schedule can legally enter the food supply. An Application Handbook provides information that is required to make an application to vary the Code. This Handbook is a legal document and therefore the specified mandatory information must be supplied. For GM foods, there is also a Guidance Document that, as the name suggests, provides applicants with further details and background information on the data needed for the safety assessment of GM foods. The assessment process must be completed within a statutory timeframe (9 - 12 months depending on the complexity of the application) and involves at least one public consultation period. All GM applications involve an Exclusive Capturable Commercial Benefit i.e. applicants are required to pay a fee (outlined in the Application Handbook). Following the last public consultation, an Approval Report is prepared and is considered by the FSANZ Board who make a decision about whether the requested variation to the Code should be approved or not. The Board's decision is then passed on to the Legislative and Governance Forum on Food Regulation (the Forum), a committee comprising senior goevernment Ministers from Australia and NZ. This Committee has approximately 2 months to review the Board's decision. If the Board's approval is accepted by the Forum, the approval is then gazetted and becomes law.
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)
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)
Canada
Name of product applicant: Syngenta Canada Inc.
Summary of application:

Syngenta Seeds Canada developed Insect Resistant Maize 5307 using recombinant DNA techniques to introduce the coding sequence for a synthetic insecticidal protein (ecry3.1Ab). This coding sequence was engineered using the coding sequences from two naturally occurring Cry proteins (Cry3A and Cry1Ab) from Bacillus thuringiensis. The sequence codes for the eCry3.1Ab protein which is an insecticidal agent for corn rootworm (Diabrotica spp.) pests. The introduction of this gene confers resistance to coleopteran corn pests.

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Date of authorization: 22/02/2013
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.): BioTrack Product Database
Summary of the safety assessment:
Please see decision document weblinks
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: Novel Foods Decision
Novel Feeds Decision
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Authorization expiration date:
E-mail:
luc.bourbonniere@hc-sc.gc.ca
Organization/agency name (Full name):
Health Canada
Contact person name:
Luc Bourbonniere
Website:
Physical full address:
251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number:
613-957-1405
Fax number:
613-952-6400
Country introduction:
Federal responsibility for the regulations dealing with foods sold in Canada, including novel foods, is shared by Health Canada and the Canadian Food Inspection Agency (CFIA). Health Canada is responsible for establishing standards and policies governing the safety and nutritional quality of foods and developing labelling policies related to health and nutrition. The CFIA develops standards related to the packaging, labelling and advertising of foods, and handles all inspection and enforcement duties. The CFIA also has responsibility for the regulation of seeds, veterinary biologics, fertilizers and livestock feeds. More specifically, CFIA is responsible for the regulations and guidelines dealing with cultivating plants with novel traits and dealing with livestock feeds and for conducting the respective safety assessments, whereas Health Canada is responsible for the regulations and guidelines pertaining to novel foods and for conducting safety assessments of novel foods. The mechanism by which Health Canada controls the sale of novel foods in Canada is the mandatory pre-market notification requirement as set out in Division 28 of Part B of the Food and Drug Regulations (see Figure 1). Manufacturers or importers are required under these regulations to submit information to Health Canada regarding the product in question so that a determination can be made with respect to the product's safety prior to sale. The safety criteria for the assessment of novel foods outlined in the current document were derived from internationally established scientific principles and guidelines developed through the work of the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organisation (FAO), World Health Organisation (WHO) and the Codex Alimentarius Commission. These guidelines provide for both the rigour and the flexibility required to determine the need for notification and to conduct the safety assessment of the broad range of food products being developed. This flexibility is needed to allow novel foods and food products to be assessed on a case-by-case basis and to take into consideration future scientific advances.
Useful links
Relevant documents
Stacked events:
Food: Consistent with the definition of "novel food" in Division 28 of the Food and Drug Regulations, the progeny derived from the conventional breeding of approved genetically modified plants (one or both parents are genetically modified) would not be classified as a novel food unless some form of novelty was introduced into such progeny as a result of the cross, hence triggering the requirement for pre-market notification under Division 28. For example, notification may be required for modifications observed in the progeny that result in a change of existing characteristics of the plant that places those characteristics outside of the accepted range, or, that introduce new characteristics not previously observed in that plant (e.g. a major change has occurred in the expression levels of traits when stacked). In addition, the use of a wild species (interspecific cross) not having a history of safe use in the food supply in the development of a new plant line may also require notification to Health Canada. However, molecular stacks are considered new events and are considered to be notifiable as per Division 28.

Feed:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Luc Bourbonniere, Section Head Novel Foods
Japan
Name of product applicant: Syngenta Japan K.K.
Summary of application:

Corn line 5307 is a genetically modified (GM) corn that is protected from feeding damage caused by the larvae of a number of insect pest species.

Upload:
Date of authorization: 26/02/2013
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).
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: 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) 5307. Identificador OECD: SYN-Ø53Ø7-1. Resistente a insectos coleópteros por la expresión de la proteína insecticida eCry3.1Ab.


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 evento 5307 expresa las proteínas eCry3.1Ab y PMI, la primera   confiriéndole resistencia a las especies plaga del maíz: gusano occidental de   la raíz (Diabrotica virgifera virgifera)   y gusano norteño de la raíz (Diabrotica   longicornis barberi), y la segunda actuando como marcador de selección.   Se obtuvo por transformación genética mediada por Agrobacterium tumefaciens, realizada sobre embriones inmaduros de   líneas de maíz. El gen pmi fue   obtenido de Escherichia coli cepa   K-12 y la proteína que codifica fue utilizada como un marcador selectivo   durante el desarrollo del maíz 5307.


El plásmido insertado contiene dos casetes de importancia para la   transformación, uno con los genes de interés y otro con los marcadores de   selección. El gen mcry3A que   codifica para la proteína mCry3A es una versión modificada de la proteína   Cry3A perteneciente al grupo de proteínas insecticidas cristalinas (Cry)   producidas por Bacillus thuringiensis.   Las células de maíz que producen la proteína PMI pueden utilizar la manosa   como fuente primaria de carbono.



 

Upload:
Date of authorization: 26/08/2013
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-Ø53Ø7-1 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: Estados Unidos (2012) Canadá (2013) Japón (2013) Conclusión: No se observaron efectos tóxicos, alérgicos o cambios nutrimentales sustanciales en el maíz genéticamente modificado evento SYN-Ø53Ø7-1 Por lo tanto puede asegurarse que el evento es, con base en los conocimientos existentes hasta la fecha, tan inocuo como su homólogo convencional.
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:
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