| Commodity: |
Soyabean / Soybeans |
| Traits: |
Glufosinate tolerance,Mesotrione tolerance |
| Name of product applicant: |
Syngenta Crop Protection AG |
| Summary of application: |
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| Date of authorization: |
22/01/2022 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
EU Register of authorised GMOs
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| Summary of the safety assessment (food safety): |
Please see the EU relevant 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: |
Method for detection: Event specific real-time quantitative PCR based method for detection of the genetically modified soybean SYN-ØØØH2-5.
Reference material:AOCS 0112-A is accessible via the American Oil Chemists Society (AOCS) |
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Method for detection
Reference Material
Opinion of the European Food Safety Authority
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| Authorization expiration date (a blank field means there is no expiration date) |
21/01/2031 |
E-mail:
Organization/agency name (Full name): European Union
Contact person name: Alexandre Huchelmann
Website:
Physical full address: European Commission B232 04/106 1047 Brussels
Phone number: 3222954092
Fax number:
Country introduction: The process for authorising a new GMO is based on the EU regulation on GM food and feed (1829/2003). An application for authorising food or feed consisting of or made from a GMO must be submitted to the national authorities. The national authority then sends the application to the European Food Safety Agency (EFSA) for a risk assessment. EFSA then makes the application summary available to the public. No matter where in the EU the company applies, EFSA assesses the risks the GMO presents for the environment, human health and animal safety. If the application covers cultivation, EFSA delegates the environmental risk assessment to an EU country which sends EFSA its risk assessment report. After performing the risk assessment, EFSA submits its scientific opinion to the European Commission and to EU countries. The opinion is made available to the public, except for certain confidential aspects. Once EFSA publishes its risk assessment, the public has 30 days to comment on the Commission website for applications under Reg. 1829/2003, and on the Joint Research Centre website on the assessment report of the "lead" EU country for applications under Directive 2001/18. Within 3 months of receiving EFSA's opinion, the Commission grants or refuses the authorisation in a proposal. If it differs from EFSA’s opinion, it must explain why. National representatives approve the Commission’s proposal by qualified majority in: (1) The Standing Committee on the Food Chain and Animal Health if the application was submitted under Reg. 1829/2003; (2) The Regulatory Committee under Directive 2001/18/EC if the application was submitted under Dir. 2001/18. The proposal is adopted if the Committee agrees with it. If there is no opinion, the Commission may summon an Appeal Committee where EU countries can adopt or reject the proposal. If the Appeal Committee makes no decision, the Commission may adopt its proposal. Authorisations are valid for 10 years (renewable). Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
Bayer S.A. + Syngenta Agro S.A. |
| Summary of application: |
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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.): |
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| 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: |
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| 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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E-mail:
Organization/agency name (Full name): Ministerio de Agroindustria
Contact person name: Andrés Maggi
Website:
Physical full address: Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number: 54 11 5222 5986
Fax number:
Country introduction: In Argentina, the food and feed risk assessment process of transformation events, as the result of modern biotechnology, is carried out by the National Service for Agrifood Health and Quality (Senasa). The General Office of Biotechnology, is the area responsible for carrying out this task. It has an specific professional team and the advise of a Technical Advisory Committee composed of experts from several scientific disciplines representing different sectors involved in the production, industrialization, consumption, research and development of genetically modified organisms. Useful links
Relevant documents
Stacked events: Stacked events with all single events approved, are assessed as a new event, but with much less requirements, always on a case-by-case basis. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: National Service for Agrifood Health and Quality (Senasa)
https://www.argentina.gob.ar/senasa
https://www.argentina.gob.ar/senasa/programas-sanitarios/biotecnologia
| Name of product applicant: |
Bayer CropScience/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
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| 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: |
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| 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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E-mail:
Organization/agency name (Full name): Food Standards Australia New Zealand
Contact person name: Gaya Subramaniam
Website:
Physical full address: Level 4, 15 Lancaster Place, Majura Park ACT 2609, Australia
Phone number: +61 2 6271 2222
Fax number: +61 2 6271 2278
Country introduction: Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 115 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 10 staff) is located in Wellington on the North Island. Useful links
Relevant documents
Stacked events: FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)
No separate approval or safety assessment is necessary for foods derived from a stacked GM line that is the result of traditional breeding between a number of GM parent lines for which food has already been approved. Food from the parent lines must be listed in the Australia New Zealand Food Standards Code. The parent lines may contain any number of different genes. If food from any of the GM parent lines has not been approved, then a full pre-market safety assessment of food from the stacked line must be undertaken.
No separate approval is required for food derived from a line that is the product of a GM line, for which food has been approved, crossed traditionally with a non-GM line.
Where a single line containing a number of genes has been produced as a result of direct gene technology methods (rather than traditional crossing) then food derived from the line must undergo a full pre-market safety assessment before approval can be given Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)
| Name of product applicant: |
Bayer CropScience Inc. and Syngenta Seeds Canada Inc. |
| Summary of application: |
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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
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| 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: |
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| 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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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. 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: Neil Strand, Section Head of Novel Foods
| Name of product applicant: |
Bayern Crop Science |
| Summary of application: |
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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.): |
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| 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: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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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. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
Syngenta Japan KK Bayer CropScience Ltd. |
| Summary of application: |
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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.): |
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| Summary of the safety assessment (food safety): |
Please see the links below. |
| Upload: |
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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: |
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| 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) |
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E-mail:
Organization/agency name (Full name): Food Safety Commission Secretariat,Cabinet Office,
Contact person name: Kojiro Yokonuma
Website:
Physical full address: Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number: 81 3 6234 1122
Fax number: 81 3 3584 7392
Country introduction: Safety assessments of GM foods are mandatory under the Food Sanitation Law in Japan. The Ministry of Health, Labour, and Welfare (MHLW) legally imposes safety assessments of GM foods so that those that have not undergone safety assessments would not be distributed in the country. MHLW receives application and requests the Food Safety COmmission of Japan (FSCJ) to evaluate the safety of GM foods in terms of human health. Safety assessments are carried out by FSCJ. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
Syngenta Crop Protection Sdn. Bhd. |
| Summary of application: |
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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.): |
Department of Biosafety Malaysia
CBD Biosafety Clearing House
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| Summary of the safety assessment (food safety): |
Please refer to the Risk Assessment Report |
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
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| 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) |
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E-mail:
Organization/agency name (Full name): Department of Biosafety Malaysia
Contact person name: Dr. Anita Anthonysamy
Website:
Physical full address: Department of Biosafety,
Ministry of Natural Resources, Environment and Climate Change
Level 4, Block F11, Complex F
Lebuh Perdana Timur, Precinct 1
62000 Putrajaya, Malaysia
Phone number: +60380917322
Fax number: +60380917371
Country introduction: GM food safety assessment is a requirement by law under the Biosafety Act 2007 in Malaysia. The National Biosafety Board reviews and makes decisions on events based on a scientific/technical risk assessment, policy considerations as well as public input. The decisions and its related documents made are publicly available through the Malaysian Department of Biosafety Website and the Convention of Biological Diversity Biosafety Clearing House. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Department of Biosafety, Ministry of Natural Resources and Environmental Sustainability, Level 4, Block F11, Complex F Lebuh Perdana Timur, Precinct 1 62000 Putrajaya, Malaysia. Email: [email protected]. Url: www. biosafety.gov.my
Food Safety and Quality Division, Ministry of Health, Level 4, Menara Prisma, No. 26, Persiaran Perdana, Putrajaya, Malaysia, 62675. Phone: +603 88850797 Fax: +603 88850790 Email: [email protected]
| Name of product applicant: |
Syngenta Agro, S.A. de C.V. |
| Summary of application: |
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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.): |
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| 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: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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E-mail:
Organization/agency name (Full name): CIBIOGEM
Contact person name: Dra. Consuelo López López
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 Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
Bayer CropScience/Syngenta |
| Summary of application: |
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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
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| 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: |
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| 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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E-mail:
Organization/agency name (Full name): Ministry for Primary Industries
Contact person name: john vandenbeuken
Website:
Physical full address: Pastoral House, 25 The Terrace, Wellington, 6012
Phone number: 0298942581
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:
| Name of product applicant: |
SYNGENTA PARAGUAY S.A. |
| Summary of application: |
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| Date of authorization: |
08/11/2019 |
| 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.): |
SYN-ØØØH2-5
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| Summary of the safety assessment (food safety): |
The food and feed safety assessment was performed following the CODEX Guidelines. |
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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: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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E-mail:
Organization/agency name (Full name): Ministerio de Agricultura y Ganadería
Contact person name: Santiago Bertoni
Website:
Physical full address: Yegros 437 entre 25 de mayo y Cerro Cora
Phone number: +595 981 256262
Fax number:
Country introduction: The agricultural sector is one of the economic pillars of Paraguay in its contribution to the GDP, with the main crops being soybean, cassava, maize, wheat, sugar cane, and cotton. It should also be noted that Paraguay is the world’s fourth exporter of soybean. In 2020, the area planted with crops was 4.67 million hectares and consisted of soybean (3.56 million hectares), maize (1.08 million hectares), and cotton (18,000 hectares). Agricultural biotechnology was first regulated in Paraguay in 1997. In 2012, the system was adjusted through the creation of the National Agricultural and Forestry Biosafety Commission (CONBIO), “with the mission to manage, analyze, and issue recommendations on all matters related to the introduction, confined field trials, pre-commercial and commercial release, and other intended uses of GE crops” Almost 94% of the soybean, 36% of the maize, and 56% of the cotton planted in the country are GE. Useful links
Relevant documents
Stacked events: When a stacked event is approved, all possible combinations are approved. Previously evaluated single events are not reevaluated in stacks. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: In 2012, the system was adjusted through the creation of the National Agricultural and Forestry Biosafety Commission (CONBIO), “with the mission to manage, analyze, and issue recommendations on all matters related to the introduction, confined field trials, pre-commercial and commercial release, and other intended uses of GE crops”. Additional information https://conbio.mag.gov.py/
| Name of product applicant: |
Syngenta Paraguay S.A. |
| Summary of application: |
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| Date of authorization: |
08/11/2019 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
The Commercial Release Opinion of the National Commission of Agricultural and Forestry Biosafety (CONBIO), in its substantial part states: "...Recommends technically: (1) The commercial release of event SYN-ØØØH2-5 (SYNHT0H2) (2) In case of detecting an unexpected effect, the company is under the obligation to communicate it to CONBIO". Please see decision document weblinks. For further information, please refer to the decision document link. |
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E-mail:
Organization/agency name (Full name): Ministerio de Agricultura y Ganadería
Contact person name: Santiago Bertoni
Website:
Physical full address: Yegros 437 entre 25 de mayo y Cerro Cora
Phone number: +595 981 256262
Fax number:
Country introduction: The agricultural sector is one of the economic pillars of Paraguay in its contribution to the GDP, with the main crops being soybean, cassava, maize, wheat, sugar cane, and cotton. It should also be noted that Paraguay is the world’s fourth exporter of soybean. In 2020, the area planted with crops was 4.67 million hectares and consisted of soybean (3.56 million hectares), maize (1.08 million hectares), and cotton (18,000 hectares). Agricultural biotechnology was first regulated in Paraguay in 1997. In 2012, the system was adjusted through the creation of the National Agricultural and Forestry Biosafety Commission (CONBIO), “with the mission to manage, analyze, and issue recommendations on all matters related to the introduction, confined field trials, pre-commercial and commercial release, and other intended uses of GE crops” Almost 94% of the soybean, 36% of the maize, and 56% of the cotton planted in the country are GE. Useful links
Relevant documents
Stacked events: When a stacked event is approved, all possible combinations are approved. Previously evaluated single events are not reevaluated in stacks. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: In 2012, the system was adjusted through the creation of the National Agricultural and Forestry Biosafety Commission (CONBIO), “with the mission to manage, analyze, and issue recommendations on all matters related to the introduction, confined field trials, pre-commercial and commercial release, and other intended uses of GE crops”. Additional information https://conbio.mag.gov.py/
| Name of product applicant: |
Syngenta Philippines Inc. |
| Summary of application: |
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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 |
E-mail:
Organization/agency name (Full name): Bureau of Plant Industry
Contact person name: Geronima P. Eusebio
Website:
Physical full address: San Andres St., Malate, Manila
Phone number: 632 404 0409 loc 203
Fax number:
Country introduction: In 1987, scientists from the University of the Philippines Los Banos (UPLB) and the International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI), and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD), recognizing the potential harm of the introduction of exotic species and genetic engineering, formed a committee and formulated the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. The committee went on to draft a Philippine biosafety policy, which was submitted to the Office of the President. On October 15, 1990, recognizing the potential for modern biotechnology both in improving the lives of the people and in creating hazards if not handled properly, President Corazon C. Aquino issued Executive Order 430 creating the National Committee on Biosafety of the Philippines (NCBP) that will formulate, review and amend national policy on biosafety and formulate guidelines on the conduct of activities on genetic engineering. The NCBP is comprised of representative of the Departments of Agriculture (DA); Environment and Natural Resources (DENR); Health (DOH); and Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science; and 2 respected members of the community. On July 16, 2001, President Gloria Macapagal-Arroyo issued the Policy Statement on Modern Biotechnology, reiterating the government policy on promoting the safe and responsible use of modern biotechnology. On April 3, 2002, Department of Agriculture Administrative Order No. 8, Series of 2002 was issued implementing the guidelines for importation and release into the environment of Plants and Plant Products Derived from the Use of Modern Biotechnology. On March 17, 2006, President Gloria Macapagal-Arroyo issued Executive Order No.514 Establishing the National Biosafety Framework, prescribing guidelines for its implementation, reorganizing the National Committee on Biosafety of the Philippines, and for other purposes. On December 8, 2015, the Philippine Supreme Court declared DA AO8 null and void and any application for contained use, field testing, propagation and commercialization, and importation of GMOs was temporarily enjoined. In response to the nullification of DA AO8, the Technical Working Group composed of representatives from the Departments of Agriculture (DA), Science and Technology (DOST), Environment and Natural Resources (DENR), Health (DOH), and Interior and Local Government (DILG) drafted the Joint Department Circular No. 1, Series of 2016 (JDC No.1, S2016) titled 'Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically-Modified Plant and Plant Products Derived from the Use of Modern Biotechnology'. There were series of meeting and five public consultations conducted before the JDC No.1, S2016 was approved and signed by the Secretaries of the abovementioned agencies on March 7, 2016 and took effect on April 15, 2016. Under this Circular, more government agencies were involved such as the Department of Science and Technology (DOST) to regulate applications for contained use and confined test of regulated articles; Department of Agriculture (DA) to evaluate applications for field trial, commercial propagation and transboundary movement of regulated articles; Department of Environment and Natural Resources (DENR) to evaluate environmental risks and impacts of regulated articles; Department of Health (DOH) to evaluate of environmental health impacts of regulated articles; and Department of the Interior and Local Government (DILG) to supervise public consultation during field trial.
Useful links
Relevant documents
Stacked events: Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.
Plant Products Carrying Stacked Genes Conferred Through (a) Genetic Engineering or b) Conventional Breeding, with Individual Traits That Have No Prior Approval:
A full risk assessnent as to food and feed or processing shall be conducted,consistent with Part V of AO No. 8,"Approval Process For the Importation of Regulated Articles for Direct Use as Food and Feed or For Processing for plant products with multiple traits conferred through:
(a) genetic engineering, or
(b) conventional breeding, where the individual traits have no prior approval from the Bureau of Plant Industry (BPI) for direct use as food and feed or processing.
Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:
For plant products with multiple traits conferred through conventional breeding,with all individual events granted prior approval and included in the Approval Registry, a notlfication shall be submitted by the technology developer to the BPI, which shall conduct an evaluation in accordance with the relevant criteria in Annex I of this Memorandum Circular. The list of data contained in Annex I will not preclude the inclusion of other issues and concerns that will be raised by the BPI and the Scientific and Technical Review Panel (STRP) during the course of the desktop review.
Notificatlon Requirement for Plant Products Carrying Stacked Genes
All technology developers shall submit a notification to the Bureau of Plant Industry of their developed plant products carrying stacked genes and shall be required to comply with the relevant approval process listed above.
The Bureau of Plant Industry shall issue a certiflcate as to the approval of the stacked gene product and shall likewise include the transformation event in the official approval registry of plant products for food and feed or processing. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004
| Name of product applicant: |
Syngenta Korea |
| Summary of application: |
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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.): |
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| Summary of the safety assessment (food safety): |
Please see the link below(in Korean). |
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E-mail:
Organization/agency name (Full name): Ministry of Food and Drug Safety
Contact person name:
Website:
Physical full address: Osong Health Technology Administration Complex, 187, Osongsaengmyeong 2-ro, Osong-eup, Cheongwon-gun, Chungcheonbuk-do, 363-700, Korea
Phone number: 82-43-719-2360
Fax number:
Country introduction:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
Syngenta Crop Protection AG |
| Summary of application: |
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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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E-mail:
Organization/agency name (Full name): FSBI «Institute of Nutrition» RAMS
Contact person name: Nadezhda Tyshko
Website:
Physical full address: 109240, Russia, Moscow, Ustinsky Proezd, 2/14
Phone number: +7(495)698-53-64
Fax number:
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. Useful links
Relevant documents
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
| Name of product applicant: |
Syngenta |
| Summary of application: |
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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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E-mail:
Organization/agency name (Full name): Singapore Food Agency (SFA)
Contact person name: Dr Tan Yong Quan
Website:
Physical full address: 52 Jurong Gateway Road 14-01 JEM Office Tower Singapore 608550
Phone number: (65)68052750
Fax number:
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. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Singapore Food Agency (SFA)
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Syngenta |
| Summary of application: |
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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)
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| 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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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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E-mail:
Organization/agency name (Full name): Department of Agriculture Forestry and Fisheries
Contact person name: Nompumelelo Mkhonza
Website:
Physical full address: 30 Hamilton street, Harvest House building, Arcadia, Pretoria, 0001
Phone number: +2712 319 6382
Fax number: +2712 319 6298
Country introduction:
Useful links
Relevant documents
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
| Name of product applicant: |
Syngenta Seeds (Thailand) Limited. |
| Summary of application: |
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| Date of authorization: |
04/12/2022 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
The food safety assessment performed by the National Center for Genetic Engineering and Biotechnology (BIOTEC) as advisory and technical arm of Thai FDA. BIOTEC conduct food safety assessment according to codex guideline and based on the safety data and information provided by the applicant (as specified in Annex 2 attached to Notification of the Ministry of Public Health No.431). According to the existing scientific data and information available during the safety assessment, it is concluded that the soybean event SYHT0H2 is substantially equivalent to its conventional counterpart in terms of morphology, nutrition, toxicity and allergenicity. |
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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: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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E-mail:
Organization/agency name (Full name): National Burequ of Agricultural Commodity and Food
Contact person name: Director of Office of Standard Development
Website:
Physical full address: 50 Phahonyothin Rd., Lardyao, Chathuchak, Bangkok 10900
Phone number: +6625612277 ext.1401
Fax number: +6625613373
Country introduction: National Bureau of Agricultural Commodity and Food Standards (ACFS) is a governmental agency under the Ministry of Agriculture and Cooperatives (MOAC) responsible for the development of national agricultural and food standards. The Agricultural Standards Act B.E. 2551 (2008) establishes the mechanisms for the development of Thai Agricultural Standards (TAS) as either voluntary or mandatory standards. This is based on scientific data, consumer’s health and fair trade. Within the TAS, there are four standards relating GM food assessment, namely Principle for the Risk Analysis of Foods Derived from Biotechnology (TAS 9010-2006), Assessment of Possible Allergenicity (TAS 9011-2006), Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (TAS 9012-2006) and Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms (TAS 9013-2006). These standards are adapted from relevant Codex standards. Safety assessment for imported GM crops and foods is done by the cooperation of the Food and Drug Administration (FDA) and the National Center for Genetic Engineering and Biotechnology (BIOTEC)via the Committees relating National Committees to consider technical and political issues. The Committees comprise representatives from all relevant governmental and non-governmental key sectors including experts on genetic modification, toxicity and others.
The safety assessment process of GM food in Thailand is on a voluntary basis. According to the current laws and regulations, there is no approval authority. Useful links
Relevant documents
Stacked events: The safety assessment for stacked events is divided into two patterns. The first pattern is for stacked events whose GM parents have never approved by FDA or other competent authority. Those stacked events shall be fully assessed in line with GM foods. Another pattern is introduced for the safety assessment of stacked event lines where from GM parents had already been approved. In the second pattern, the information of the parents could be used for consideration, as appropriate. However, the information relevant to interaction between genes and new proteins of stacked event should be mainly taken into account. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Food and Drug Administration (FDA) and National Center for Genetic Engineering and Biotechnology (BIOTEC)
| Name of product applicant: |
Syngenta Seeds, Inc. and Bayer Crop Science AG |
| Summary of application: |
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| Date of authorization: |
28/03/2014 |
| 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.): |
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| 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: |
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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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E-mail:
Organization/agency name (Full name): Food and Drug Administration
Contact person name: Jason Dietz
Website:
Physical full address: 5100 Paint Branch Parkway, College Park MD 20740
Phone number: 240-402-2282
Fax number:
Country introduction: 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. Useful links
Relevant documents
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:
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