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OECD Unique Identifier details

SYN-ØØØH2-5
Commodity: Soyabean / Soybeans
Traits: Glufosinate tolerance,Mesotrione tolerance
Argentina
Name of product applicant: Bayer S.A. + Syngenta Agro S.A.
Summary of application:

Syngenta Agro SA and Bayer SA have developed a transgenic soybean cultivar that is tolerant to the applications of herbicides containing glufosinate-ammonium and to herbicides belonging to the family of p-hydroxyphenylpyruvate dioxygenase (HPPD) inhibitors (such as mesotrione, among others). The soybean derived from the transformation event SYHT0H2, was developed using the transformation method mediated by Agrobacterium tumefasciens, with the aim of stably incorporating the genes pat and avhppd-03 into its genome.
The pat gene, derived from Streptomyces viridochromogenes, codes for the enzyme phosphinotricin acetyltransferase (PAT). When this protein is expressed in plants, it has the ability to acetylate L-phosphinothricin, the active component of the glufosinate-ammonium herbicide, resulting in a post-emergence herbicide-tolerant phenotype. The avhppd-03 gene codes for the enzyme p-hydroxyphenylpyruvate dioxygenase (AvHPPD-03) derived from oats (Avena sativa). The AvHPPD-03 protein has a lower binding affinity to the herbicides belonging to the family of HPPD inhibitors, in comparison to the HPPD enzyme native to soybeans. When the avhppd-03 gene is expressed in soybeans SYHT0H2 confers pre- and post-emergent tolerance to this type of herbicides.

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Date of authorization: 23/11/2016
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):
• Inheritance studies conducted indicated that Mendelian segregation exists. • New expression proteins are expressed in low levels. • It is compositionally equivalent to its non-transgenic counterpart. • No evidence of similarity or homology was found with known toxic proteins. • There is no evidence of expression of known allergenic substances for the proteins expressed in the event. It is concluded that the event is substantially equivalent to its conventional counterpart, therefore, it is as safe and no less nutritious than conventional commercial varieties.
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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: GMO commercial approvals in Argentina
GMO approvals for food/feed
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Authorization expiration date (a blank field means there is no expiration date)
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.

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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

Australia
Name of product applicant: Bayer CropScience/Syngenta
Summary of application:
A genetically modified (GM) soybean line with OECD Unique Identifier SYN-000H2-5, hereafter referred to as soybean SYHT0H2, has been developed to be tolerant to two herbicides with different modes of action, namely glufosinate-ammonium and mesotrione.
Tolerance to glufosinate ammonium is achieved through expression of the enzyme phosphinothricin acetyltransferase (PAT) encoded by two similar pat genes (pat-03-01 and pat-03-02) both derived from the soil bacterium Streptomyces viridochromogenes. Tolerance to mesotrione is achieved through expression of the p-hydroxyphenylpyruvate dioxygenase (AvHPPD-03) protein encoded by the avhppd-03 gene from oat (Avena sativa). The pat gene has been widely used for genetic modification of a number of crop species, including soybean. An HPPD protein has been previously assessed by FSANZ in Application A1051 where it was used to confer tolerance in soybean to isoxazole herbicides.
It is anticipated that soybean SYHT0H2 may be grown in the United States of America, Argentina, Brazil, China and India subject to approval. The Applicant has not indicated that there is any intention to grow the plant line 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: 27/02/2014
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
Summary of the safety assessment (food safety):
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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: A1081 – Food derived from Herbicide-tolerant Soybean Event SYHT0H2
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Authorization expiration date (a blank field means there is no expiration date)
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.

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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)

Canada
Name of product applicant: Bayer CropScience Inc. and Syngenta Seeds Canada Inc.
Summary of application:

Syngenta Seeds Canada and Bayer CropScience developed Herbicide Tolerant Soybean SYHT0H2 using recombinant DNA techniques to introduce the p-hydroxyphenylpyruvate dioxygenase (HPPD) coding sequence (avhppd-03) derived from Avena sativa (oat). Herbicides that inhibit HPPD have a lower binding affinity for the expressed AvHPPD-03 protein, which acts in place of the native soybean HPPD in the tyrosine catabolic pathway to provide the desired herbicide tolerance. This event was also modified to introduce two copies of the coding sequence for phosphinothricin acetyl-transferase (pat) from Streptomyces viridochromogenes strain Tü494. The expressed PAT protein acetylates L-phosphinothricin, the active compound in glufosinate herbicides, rendering it inert.

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Date of authorization: 15/05/2014
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.): BioTrack Product Database
Summary of the safety assessment (food safety):
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: Novel Foods Decision Document
Novel Feeds Decision Document
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Health Canada
Contact person name:
Neil Strand
Website:
Physical full address:
251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number:
613-946-1317
Fax number:
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.

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 guidance document (i.e. Canadian Guidelines for the Safety Assessment of Novel Foods) 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.

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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:

Neil Strand, Section Head of Novel Foods

Colombia
Name of product applicant: Bayern Crop Science
Summary of application:

Authorization of the genetically modified soy SYHT0H2 tolerant to the herbicide glufosinate

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Date of authorization: 10/02/2017
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.
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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 (a blank field means there is no expiration date)
E-mail:
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.

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Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Japan
Name of product applicant: Syngenta Japan KK Bayer CropScience Ltd.
Summary of application:

A soybean SYHT0H2 tolerant to herbicide against p-hydroxyphenylpyruvate dioxygenase and to glufosinate

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Date of authorization: 25/04/2016
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 links below.
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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 (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,
Contact person name:
Mariko Murakami
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:

With regard to stacked events, FSCJ conducts the safety assessment of GM food based on the “Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants”.

Even if single events that are stacked have already approved, some products will be considered as new products and some will not.

Please refer to Article 5 and 6 of the MHLW’s notice, which is available at the following URL, for the details.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000053519.pdf

Article 6 was modified in 2014, and the modified version is available at the following URL.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000049695.pdf

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)

Malaysia
Name of product applicant: Syngenta Crop Protection Sdn. Bhd.
Summary of application:

Please refer to the decision document of the National Biosafety Board. 

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Date of authorization: 23/06/2016
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.): Malaysia Biosafety Clearing House
CBD Biosafety Clearing House
Summary of the safety assessment (food safety):
Please refer to the Risk Assessment Report
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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 (a blank field means there is no expiration date)
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 Environment and Water 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 Malaysia, Level 1, Podium 2, Wisma Sumber Asli No. 25, Persiaran Perdana, Precinct 4 Putrajaya, Federal Territory Malaysia, 62574. Phone: +603 8886 1746 / 1579. Fax: +603-8889 5604 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]
Mexico
Name of product applicant: Syngenta Agro, S.A. de C.V.
Summary of application:

Authorization by COFEPRIS: 138


A genetically modified (GM) soybean line with OECD Unique Identifier SYN-000H2-5, hereafter referred to as soybean SYHT0H2, has been developed to be tolerant to two herbicides with different modes of action, namely glufosinate-ammonium and mesotrione.

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Date of authorization: 24/02/2015
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):
UI OECD: SYN-ØØØH2-5 During the risk assessment of this GMO based on existing knowledge to date, no toxic or allergic effects neither substantial nutritional changes are observed. The event is as safe as its conventional counterpart. For more detail please find attached the risk assessment summary in this page.
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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 (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
CIBIOGEM
Contact person name:
Biól. Erica L. Hagman Aguilar
Website:
Physical full address:
San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number:
+52 (55) 53227700
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

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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: [email protected]%20

New Zealand
Name of product applicant: Bayer CropScience/Syngenta
Summary of application:

A genetically modified (GM) soybean line with OECD Unique Identifier SYN-000H2-5, hereafter referred to as soybean SYHT0H2, has been developed to be tolerant to two herbicides with different modes of action, namely glufosinate-ammonium and mesotrione. 
Tolerance to glufosinate ammonium is achieved through expression of the enzyme phosphinothricin acetyltransferase (PAT) encoded by two similar pat genes (pat-03-01 and pat-03-02) both derived from the soil bacterium Streptomyces viridochromogenes. Tolerance to mesotrione is achieved through expression of the p-hydroxyphenylpyruvate dioxygenase (AvHPPD-03) protein encoded by the avhppd-03 gene from oat (Avena sativa). The pat gene has been widely used for genetic modification of a number of crop species, including soybean. An HPPD protein has been previously assessed by FSANZ in Application A1051 where it was used to confer tolerance in soybean to isoxazole herbicides. 
It is anticipated that soybean SYHT0H2 may be grown in the United States of America, Argentina, Brazil, China and India subject to approval. The Applicant has not indicated that there is any intention to grow the plant line 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: 01/05/2014
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 (food safety):
In conducting a safety assessment of food derived from soybean line SYHT0H2, a number of criteria have been addressed including: a characterisation of the transferred gene and its origin, function and stability in the soybean genome; the changes at the level of DNA, protein and in the whole food; compositional analyses; evaluation of intended and unintended changes; and the potential for the newly expressed proteins to be either allergenic or toxic in humans. No potential public health and safety concerns have been identified in the assessment of soybean line SYHT0H2. On the basis of the data provided in the present Application, and other available information, food derived from soybean line SYHT0H2 is considered to be as safe for human consumption as food derived from conventional soybean cultivars.
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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: A1081 – Food derived from Herbicide-tolerant Soybean Event SYHT0H2
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministry for Primary Industries
Contact person name:
Fiapaipai Auapaau
Website:
Physical full address:
Pastoral House, 25 The Terrace, Wellington, 6012
Phone number:
+6448314946
Fax number:
Country introduction:

New Zealand and Australia share a joint food regulation system for the composition of labelling of most foods. Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of the joint 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.

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)

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

In accordance with Article VII. Section 20 of the JDC, no regulated article, whether imported or developed domestically, shall be permitted for direct use as food and feed, or for processing, unless: (1) the Biosafety Permit for Direct Use has been issued by the BPI; (2) in the case of imported regulated article, the regulated article has been authorized for commercial distribution as food and feed in the country of origin; and (3) regardless of the intended use, the regulated article does not pose greater risks to biodiversity, human and animal health than its conventional counterpart. The BPI Biotech Office provided the assessors, except for the SEC expert, the complete dossier submitted by Bayer. Upon receipt of the individual reports from the assessors, the BPI Biotech staff prepared this consolidated risk assessment report for the information of the public

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Date of authorization: 22/06/2018
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 ASSESSMENT AND RECOMMENDATIONS Based on the documents submitted by the applicant: A. Host Organism The STRP concurred that soybean is a source of nutrients especially of vitamins K and E. the refining and processing causes partial loss of these vitamins. The panel concurred that soybean is not source of toxicants and that the antinutrients present such as trypsin inhibitors and lectins, stachyrose, raffinose oligosaccharides and phytic acids are degraded during processing. Soybean contains recognized allergenic proteins but according to STRP 3, the relevant estimate of its allergenic potential is not complete. No significant level of amino acid homology exists between the PAT gene and any protein allergens. STRPs 1 and 3 concurred that processed soybeans in its final form is consumed as food as sprouts, vegetable oils, flour, soy foods (miso, soy milk, soy sauce, tofu) and as feed specifically as soybean meal of livestock, poultry, swine and pets. STRP 1 mentions that the developer provided the list of countries that use SYHT0H2 as feed while STRP2 argues that “there is no document presented that the transgenic soybean (SYHT0H2) have been used as food in any form” B. Transgenic Plant STRP2 comments that although adequate information points that (whole, oil) is used in variety of processed foods (94% of soybean food ingredient are consumed by human) there is no document presented that the transgenic soybean (SYHT0H2) have been used as food in any forms. The expert also notes that only data on regional diets has been provided by the World Health Organization Global Environment-Food Contamination Monitoring & Assessment Program (GEMs/Food) that can be used to estimate the likely daily food consumption of soybean-based products in the Philippines (WHO, 2012). The expert has mentioned that although it was shown that 98% of soybean meal has been processed for use as feed, no data was provided to show that SYHT0H2 was used in animal feeds. STRP1 presents the need to provide the document on approval of SYHT0H2 as food or feed in various countries listed in the Basic Info Sheet. STRPs 1 and 3 agreed that with the introduction of the novel food, it is probable that the consumption of the population will change depending on how acceptable the transgenic plant is. C. Donor Organism The panel confirms that SYHT0H2 contains that gene avhppd-03 derived from Avena sativa (common oat) which encodes the enzyme AvHPPD-03 and also pat gene derived from Streptomyces viridochromogenes. Oat does not contain proteins that are listed in the FAARP 2012 allergen database and is there fore non allergenic. Reports showed that S. viridochromogenes does not have a toxic or allergenic effect on humans or animals. The genetic inserts have no known allergic properties. The DNA insert in the transgenic soybean SYHT0H2 contains a single copy of avhppd-03, four copies of pat, a single copy of the avhppd-03 enhancer complex sequence, two copies of the 35S promoter, two copies of the CMP promoter, two copies of the TMV enhancer and five copies of the NOS terminator Southern blot analysis and nucleotide sequencing were done for the extensive characterization of the DNA inserted in SYHT0H2 soybean. In addition, the soybean genome sequence flanking the SYHT0H2 inserted were identified and characterized. Results showed that the SYHT0H2 inserted did not disrupt the function of any known soybean gene. These data collectively demonstrate that no deleterious changes occurred in the SYHT0H2 soybean genome as a result of the DNA insertion The PAT regulatory enzymes are reportedly not associated with food toxins and allergens backed up by the absence of a sequence homology with known allergens or toxins. D. Transformation System The transformation of immature soybean seed to produce herbicide tolerant soybean plants is mediated by Agrobacterium tumefaciens. The genetic element in the transformation plasmid pSYN1 used to produce SYHT0H2 soybean was adequately described. The developer provided sufficient information that the target of modification is the Nuclear DNA Complete experimental protocol was provided. E. Inserted DNA Genetic Stability PCR has demonstrated the presence of one insertion site. Southern blot and nucleotide sequencing demonstrated the integrity and order of genetic elements. There were no extraneous DNA fragments from the soybean genome and transformation plasmid pSY N15954 FMV, enhancer and backbone sequences were absent. Sequence analysis of the Event SYHT0H2 Soybean insertion site at the 5’ and 3’ shows deletion of 15bp of soybean genomic sequence after the integration of the SYHT0H2 Soybean into the soybean genome and 7 bp present in the 3’ flanking region adjacent to the SYHT0H2 insert do not align to the sequence of the nontransgenic genome at the insertion site. No plasmid backbone was present as demonstrated by Southern blot analysis and two restriction enzyme digestion strategies. F. Genetic Stability The absence of unexpected bands indicates no extraneous fragments were in the insert. Southern blot was performed to demonstrate the genetic stability of the SYHT0H2 insert overtime. Stability was observed in 3 generations as confirmed by the Southern blot analysis. Real time PCR was used to determine the segregation ratios of the 2 genes and the observed ratio confirms that plants in each generation are expected to carry the gene. G. Expressed Material ELISA was used to quantify AvHPPD-03 and PAT protein from the different plant parts, with both proteins having metabolic role. Although there were considerable variabilities observed in the concentrations of AvHPPD-03 and PAT, the applicant claimed that the variabilities of the performance of their herbicide tolerant traits, (which have been demonstrated in replicate efficiency field trials) could not be attributed to the study conducted, as several levels of bias control were implemented throughout the study. Furthermore, the data on the heat stability studies of AvHPPD-03 and PAT proteins strongly suggested the reduction through processing into food/feed products would render minimal dietary exposure to these proteins. H. Toxicological Assessment The protein used in the assessment of toxicity was microbially produced AvHPPD03 from Eschericia coli and is reportedly non-toxic to mice as evidenced by the absence of mortality during two and 14-day observation. Sufficient data and analyses were provided by the developer indicating that the microbially produced AvHPPD-03 is biochemically and functionally equivalent to AvHPPD-03 produced in SYHT0H2 soybean and therefore is a suitable surrogate to evaluate the safety of AvHPPD-03 produced in SYHT0H2 soybean. Safety evaluation supports the innocuousness of the PAT gene which does not possess characteristics of a toxin or allergen, no N-glycosylation sites, easily degraded by gastric and intestinal fluids and devoid of adverse effects in mice after IV injection of a high dose. Utilizing the NCBI Entrez Protein Database in search of the similarity of the PAT amino acid sequences shows that it has no homologies with known toxins. Acute Oral Gavage tests were performed and reasonable certainty of safety is expected from the inclusion of PAT proteins inhuman food and animal feed. I. Allergenicity Assessment Both proteins were degraded by SGF and were inactivated at 65 oC and 55 0C respectively, no homology with any known or putative allergen, and there are reportedly no post-translational glycosylation in plant and microbiologically produced PAT proteins. There is a minimal chance of dietary exposure to the AvHPPD-03 and PAT protein via the transgenic soybean since they are estimated to be destroyed during processing when subjected to high temperatures. J. Nutritional Data Proximate Analysis concluded that there is no significant difference in key nutritional components of forage and seed from SYHT0H2 soybean were found to be similar in composition with the conventional soybean. The panel verified that the mean levels of calcium, magnesium and phosphorus did not differ from the control soybean while levels of iron and potassium differ significantly between the transgenic soybean and treated soybean and the control soybean at one location. No unintended, adverse consequences of the transformation process or expression of the transgenes in SYHT0H2 were evident that will affect human health and no possible risk in animal health as shown in the poultry feeding study. K. Recommendation The three recommends that the regulated article applied for human food and animal feed use is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health BPI-PPSSD ASSESSMENT AND RECOMMENDATION Host Organism (Glycine max L.) BPI-PPSD has verified that the developer provided sufficient information regarding the nutrients present in soybean which are proteins, fats, ash, carbohydrates, amino acids, minerals and vitamins. The developer also provided information on the antinutrients present in soybean meal such as stachyose, raffinose, trypsin inhibitors, lectins and phytic acid and that soybean is not associated with any toxicants. Soybean is on the list of common food that causes allergy as mentioned in Allergen Online. Soybean is consumed as food as soy milk, milk curd/tofu, whole cooked seed, edible soy oil, soy protein concentrate, isolated soy protein, hydrolyzed vegetable protein, textured soy protein and soy protein fibers. Its is also used as feed in the form of seed, forage/silage, hay, meal and hulls. Transgenic Plant (SYHT0H2) The developer provided a complete list of countries that have approved SYNT0H2 which includes Canada, Russia, Belarus, Kazakhstan, South Africa, Mexico, Australia, New Zealand, Korea, Japan and Taiwan and as feed in Canada, Colombia, Russia, South Africa, Mexico and Korea. SYHT0H2 is not likely to cause a change in consumption pattern in population subgroups. Donor Organisms (Avena sativa and Streptomyces viridochromogenes) Avena sativa is the donor organism for the avhppd-03 gene encoding the protein of the same name and is not considered an allergenic food. The PAT genes were derived from Streptomyces viridochromogenes, a common non pathogenic soil bacterium. PAT proteins and its homologues are not known to cause toxicity or allergenicity to humans or animals. History of safe use was attributed to both organisms. Expressed Material (AvHPPD-03 and PAT proteins) The enzyme AvHPPD expressed by avhppd-03 gene confers tolerance to commercial application rates of HPPD-inhibiting herbicides such as mesotrione. It is not known to be homologous to known toxin or allergen as supported by analyses provided by developer. PAT expressed by pat-09 genes is an enzyme involved in the inactivation of glufosinate ammonium through acetylation. History of safe use was attributed to PAT proteins which are not associated with any known toxins or allergens. The developer provided sufficient information that there is no possibility of any interaction of AvHPPD and PAT in a metabolic pathway. Conclusion After thorough evaluation of the documents provided by the applicant, Syngenta Philippines, Inc., the Plant Product Safety Services Division- Bureau of Plant Industry concluded that the regulated article, soybean SYHT0H2 is substantially equivalent to the conventional soybean. BAI ASSESSMENT AND RECOMMENDATIONS Based on the documents submitted by the applicant, BAI made the following assessment: A. Host Organism BAI has agreed that soybean is a source of key nutrients, such as vitamins K and E. The agency has identified soybean to be a source of antinutrients but not of toxicants. Soybean has been identified as a source of common food allergy with this event having 38 protein sequences of soybean allergens mentioned on the Allergen Online and is used as food and feed. B. Transgenic Plant BAI has stated that consumption patterns by population subgroups will not be changed as a result of introducing the novel food. C. Donor Organism BAI verifies that the synthetic gene avhppd-03,was derived from common oats which is not considered allergenic. The agency also verifies that pat genes were derived from S. viridochromogenes strain Tu494 which has not been reported as toxic or allergenic in humans or animal and that all potentially inserted regulatory sequences were adequately described. D. Transformation System BAI stated that Agrobacterium tumefaciens-mediated transformation of immature soybean seed of variety ‘Jack’ was used to produce SYHT0H2 soybean with nuclear DNA as the target of transformation. E. Inserted DNA Genetic Stability BAI confirms that the Southern blot analyses sufficiently confirmed a single integration site within the SYHT02 soybean genome and that the presence of the expected size insert was confirmed by sequencing. The likelihood that a novel protein would result from the putative ORFs of the insert was ruled out by bioinformatics analyses and showed no biological similarity to any known putative allergen or toxin. Backbone sequences were absent from the transformation plasmid. BAI confirms that the avhppd-03 gene has only been expressed in soybean while the pat gene has been expressed in maize and cotton. F. Genetic Stability BAI states that the Southern Blot analyses confirms the inheritance of the introduced traits in all three generations studied and that segregation was observed by PCR analysis and is ratio was found to be within expected values for a gene inherited according to Mendelian principles. The results of segregation analysis confirm that SYHT02 soybean carries a single insert consisting of two partial copies of the T-DNA. G. Expressed Material BAI states that the applicant provided the novel protein’s expression levels from different plant parts using ELISA. The metabolic activity of PAT and its homologues is highly specific and is limited to the acetylation of the glufosinate-ammonium herbicide, details of which were described. H. Toxicological Assessment BAI has concurred that all information relative to the toxicological assessment done to AvHPPD-03 and PAT are sufficiently described. They also agreed that the information on the digestibility studies, heat inactivation studies, Amino acid sequence comparison studies, acute oral gavage studies and protein equivalence to source proteins of the three expressed novel proteins are adequate. The two proteins are expressed independently of each other but functional activity is maintained. I. Allergenicity Assessment BAI states that bioinformatics comparisons did not find any significant level of similarity with proteins in the Allergen Protein Database. Dietary exposure to the proteins is considered minimal or non-existent. J. Nutritional Data BAI has concurred that there are no statistically differences identified between SYHT0H2 and the control soybean in terms of proximate analysis of grains and forage, levels of key nutrients and anti-nutrients and that there is no biological relevance in terms of safety. K. Recommendation After a thorough scientific review and evaluation of the documents provided by the Bureau of Plant Industry (BPI) to the BAI-Biotech Team, the Team has found scientific evidence that the regulated article applied for animal feed use is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health.
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Authorization expiration date (a blank field means there is no expiration date) June 21, 2023
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Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Geronima P. Eusebio
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Physical full address:
San Andres St., Malate, Manila
Phone number:
632 404 0409 loc 203
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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.

 

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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, Mesotrione herbicide tolerance


 

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Date of authorization: 04/11/2014
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):
Please see the link below(in Korean).
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Organization/agency name (Full name):
Ministry of Food and Drug Safety
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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
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Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Russian Federation
Name of product applicant: Syngenta Crop Protection AG
Summary of application:

There were submitted (1) data enabling to identify the matter of research (species, variety, and the transformation event); (2) data on the initial parental organism and the donor organism for introduced genetic sequences;  (3) data on the genetic modification method, genetic construction, and the level of gene expression; (4) data on identification of GM soybean line SYHT0H2 (identification methods, protocol of analysis, description of primers, reference materials); (5) data on registration of the GM line  in other countries and the results of safety assessment which conducted for registration purposes of GMO in other countries.

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Date of authorization: 12/01/2016
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):
Peer review of the data submitted by the applicant and the results of complex medical and biological studies of transgenic soybean line SYHT0H2 tolerant to HPPD-inhibiting herbicides, such as mesotrione, and to herbicides containing glufosinate ammonium, attest to the absence of any toxic, reprotoxic, genotoxic, or allergenic effects of this soybean line. By biochemical composition, transgenic soybean line SYHT0H2 was identical to conventional soybean. GM soybean line SYHT0H2 has been registered for food use, listed in the State Register, and licensed for use in the territory of the Russian Federation, import into the territory of the Russian Federation, and placing on the market without restrictions.
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Organization/agency name (Full name):
FSBI «Institute of Nutrition» RAMS
Contact person name:
Nadezhda Tyshko
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Physical full address:
109240, Russia, Moscow, Ustinsky Proezd, 2/14
Phone number:
+7(495)698-53-64
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Country introduction:

The development of the GMO safety assessment currently used in the Russian Federation started in 1995–1996. The methodological approaches to comprehensive complex medical and biological assessment of GMOs were developed in the Russian Federation with due regard for international and national experience as well as new scientific approaches based on the achievements of contemporary fundamental science: genomic and proteomic analysis, detection of DNA damage or mutagenic activity, identification of products of free-radical modifications of DNA or other sensitive biomarkers. GMO safety assessment is carried out for the state registration. Any novel food derived from plant GMO produced in Russia or imported into Russia for the first time is subject to the state registration . Guidance for safety assessment is specified in MU 2.3.2.2306-07 “Medico-Biological Safety Assessment of Plant Genetically Modified Organisms”. According to the accepted regulations,the human health assessment of a novel GMO to be placed on the domestic market includes the following: ■ Molecular assessment includes analysis of genetic construction, genetic modification method, and the gene expression level. ■ Technological assessment includes determination of organoleptic and functional properties, analysis of technological characteristics of the finished products. ■ Human health safety assessment includes several sections of required assessments: analysis of compositional equivalence and toxicological,genotoxicological, and allergological safety studies. ■ Methods for identification include qualitative and quantitative assay of GMO in food (studies targeted at determination of correspondence of these methods to those used in Russia in order to provide monitoring of use and labeling of GM food). The list and the scope of required studies is determined on the basis of analysis of information of the GMO submitted for registration; however, the above-mentioned studies are required. If significant changes in the GMO’s genome, proteome, or metabolome are shown, additional studies may be required to determine: biological value and absorbency reproductive effect; gonadotoxic, embryotoxic, teratotoxic effect; potential carcinogenic effect; lifetime, etc.

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Stacked events:

Russia follows the national Methodical Guidelines  2.3.2.3388-16 “Medical and biological safety assessment of genetically modified stack events of plant origin ”

Our position regarding GM stacks registration is very close to the EU approach.

 

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Federal Research Centre of nutrition and biotechnology Viktor A. Tutelyan Ustinsky proezd, 2/14 109240 Moscow, RUSSIA E-mail: [email protected] Tel.:+7 495 698-53-60

Singapore
Name of product applicant: Syngenta
Summary of application:

Apply for direct use as food to feed or for processing

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Date of authorization: 22/10/2018
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):
Soybean line SYHT0H2 (SYN-000H2-5) has been developed to tolerate two herbicides, glufosinate-ammonium and mesotrione. Tolerance to glufosinate ammonium is achieved through expression of the enzyme phosphinothricin acetyltransferase (PAT) encoded by a pat gene obtained from Streptomyces viridochromogenes. Tolerance to mesotrione is achieved through expression of the p-hydroxyphenylpyruvate dioxygenase (AvHPPD-03) protein encoded by the avhppd-03 gene from oat (Avena sativa). Molecular analyses showed that there is a single insertion site at which there are two inverted and truncated copies of the T-DNA from plasmid pSYN15954 with each copy containing a small added insertion sequence. With respect to the novel genes, there is a single copy of the avhppd-03 gene and four copies of the pat gene. There are also extra copies of various regulatory elements. No DNA sequences from the backbone of the transformation vector, including antibiotic resistance marker genes, were transferred to the plant. The introduced genetic elements are stably inherited from one generation to the next. Soybean line SYHT0H2 expresses two new proteins, AvHPPD-03 and PAT, which are unlikely to be toxic or allergenic in humans. Composition analyses showed that there were statistical significant differences in a number of analytes but the differences were typically small and all mean values were within both the reference range obtained for non-GM reference varieties grown at the same time and the literature range. Food derived from soybean line SYHT0H2 is considered to be as safe as food derived from conventional soybean cultivars.
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Organization/agency name (Full name):
Singapore Food Agency (SFA)
Contact person name:
Dr Tan Yong Quan
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Physical full address:
52 Jurong Gateway Road 14-01 JEM Office Tower Singapore 608550
Phone number:
(65)68052750
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Country introduction:

The Singapore Food Agency (SFA) is a Statutory Board established under the Ministry of Sustainability and the Environment (MSE) to oversee food safety and security. SFA’s mission is to ensure and secure a supply of safe food.  SFA adopts a risk-based approach to food safety. Foods with foodborne hazards that may pose potential food safety risks to consumers are subjected to more stringent checks, regardless of their country of origin. SFA has in place an integrated system to ensure that both imported and domestically produced foods are safe for consumption.  The system comprises control measures such as source accreditation, inspection and surveillance of food, laboratory analysis, food legislation and recall of food products, which safeguard food safety from farm to fork.

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Stacked events:

More information on the guidelines for the safety assessment of stacked events can be found on GMAC’s website:

http://www.gmac.sg/Index_Singapore_Guidelines_on_the_Release_of_Agriculture_Related_GMOs.html

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Singapore Food Agency (SFA)

South Africa
Name of product applicant: Syngenta
Summary of application:

The GM soybean SYHT0H2 is produced by Agrobacterium mediated transformation. The soybean expresses HPPD and Pat proteins which confer tolerance to herbicide products containing mesotrione and glufosinate.

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Date of authorization: 17/04/2014
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.): Biosafety Clearing House (BCH)
Summary of the safety assessment (food safety):
The GM soybean SYHT0H2 has been assessed in terms of the Genetically Modified Organisms Act, 1997 by the Advisory Committee a scientific panel and the Executive Council an intergovernmental decision making body. The assessment considered amongst others the following: The source of the gene, nature of host organism, protein expression, toxicology and allergenicity issues.
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Organization/agency name (Full name):
Department of Agriculture Forestry and Fisheries
Contact person name:
Nompumelelo Mkhonza
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Physical full address:
30 Hamilton street, Harvest House building, Arcadia, Pretoria, 0001
Phone number:
+2712 319 6382
Fax number:
+2712 319 6298
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Stacked events:

South Africa does not have a specific review/authorization mechanism for stacked events. Stacked events just like single events are subjected to a safety assessment as per the GMO Act.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Department of Agriculture,Forestry and Fisheries (DAFF) http://www.daff.gov.za

United States of America
Name of product applicant: Syngenta Seeds, Inc. and Bayer Crop Science AG
Summary of application:

Please consult the FDA website links below.

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Date of authorization: 28/03/2014
Scope of authorization: Food and feed
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Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: FDA's webpage regarding this variety
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Organization/agency name (Full name):
Food and Drug Administration
Contact person name:
Jason Dietz
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Physical full address:
5100 Paint Branch Parkway, College Park MD 20740
Phone number:
240-402-2282
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The United States is currently in the process of populating this database. The Food and Drug Administration regulates food and feed (food for humans and animals) from genetically engineered crops in conjunction with the Environmental Protection Agency (EPA). EPA regulates pesticides, including those that are plant incorporated protectants genetically engineered into food crops, to make sure that pesticide residues are safe for human and animal consumption and do not pose unreasonable risks of harm to human health or the environment. FDA In the Federal Register of May 29, 1992 (57 FR 22984), FDA published its "Statement of Policy: Foods Derived from New Plant Varieties" (the 1992 policy). The 1992 policy clarified the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act with respect to human and animal foods derived from new plant varieties and provided guidance to industry on scientific and regulatory issues related to these foods. The 1992 policy applied to all foods derived from all new plant varieties, including varieties that are developed using genetic engineering (also known as recombinant deoxyribonucleic acid (rDNA) technology). In the 1992 policy, FDA recommended that developers consult with FDA about foods from genetically engineered plants under development and developers have routinely done so. In June 1996, FDA provided additional guidance to industry on procedures for these consultations (the consultation procedures). These procedures describe a process in which a developer who intends to commercialize food from a genetically engineered plant meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the genetically engineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food. FDA evaluates the submission and if FDA has questions about the summary provided, it requests clarification from the developer. At the conclusion of the consultation FDA responds to the developer by letter. The approach to the safety assessment of genetically engineered food recommended by FDA during consultations, including data and information evaluated, is consistent with that described in the Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants. EPA The safe use of pesticidal substances is regulated by EPA. Food from a genetically engineered plant that is the subject of a consultation with FDA may contain an introduced pesticidal substance, also known as a plant-incorporated protectant (PIP), that is subject to food (food for humans and animals) safety and environmental review by EPA. PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. Both the PIP protein and its genetic material are regulated by EPA. When assessing the potential risks of PIPs, EPA requires studies examining numerous factors, such as risks to human health, non-target organisms and the environment, potential for gene flow, and insect resistance management plans, if needed. In regulating PIPs, decisions are based on scientific standards and input from academia, industry, other Federal agencies, and the public. Before the first PIP product was registered in 1995, EPA required that PIP products be thoroughly tested against human safety standards before they were used on human food and livestock feed crops. EPA scientists assessed a wide variety of potential effects associated with the use of PIPs, including toxicity, and allergenicity. These potential effects were evaluated in light of the public's potential exposures to these pesticides, taking into account all potential combined sources of the exposure (food, drinking water, etc.) to determine the likelihood that a person exposed at these levels would be predisposed to a health risk. Based on its reviews of the scientific studies and often peer reviews by the Federal Insecticide, Fungicide and Rodenticide Scientific Advisory Panel, EPA determined that these genetically engineered PIP products, when used in accordance with approved label directions and use restrictions, would not pose unreasonable risk to human health and the environment during their time-limited registration.

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Stacked events:

Stacked events that are each plant incorporated protectants, as defined by the Environmental Protection Agency, must be registered by the Envriornmental Protection Agency before they can be commercialized.  Food/feed safety asssessment of single events are generally sufficient to ensure the safety of food/feed from stacked events.   

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Food and Drug Administration ([email protected]); Environmental Protection Agency