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OECD Unique Identifier details

MON-Ø4Ø32-6
Commodity: Soyabean / Soybeans
Traits: Glyphosate tolerance
European Union
Name of product applicant: Monsanto
Summary of application:

The genetically modified soybean MON-Ø4Ø32-6, as described in the application, expresses the CP4 EPSPS protein which confers tolerance to the glyphosate herbicide.

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Date of authorization: 10/02/2012
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Biosafety Clearing House (BCH)
OECD BioTrack Product Database
Summary of the safety assessment (food safety):
Please see the EU 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:
Event specific real-time quantitative PCR based method for genetically modified soybean MON-Ø4Ø32-6. - Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003. Please see the EU relevant links below. Reference Material: ERM®-BF410 accessible via the Joint Research Centre (JRC) of the European Commission, Institute for Reference Materials and Measurements (IRMM) at http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Opinion of the European Food Safety Authority
Opinion of the European Food Safety Authority
Method for Detection
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Authorization expiration date (a blank field means there is no expiration date) 2/9/2022
E-mail:
pablo.pindado-carrion@ec.europa.eu
Organization/agency name (Full name):
European Union
Contact person name:
Pablo PINDADO
Website:
Physical full address:
European Commission B232 04/106 1047 Brussels
Phone number:
00 32 2 298 67 06
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:
Australia
Name of product applicant: Monsanto Australia Ltd
Summary of application:
Monsanto Australia Ltd have made an application to ANZFA to vary Standard A18
to include food derived from glyphosateûtolerant soybeans in the Table to the
standard.
Glyphosate-tolerant soybean plants are known commercially as Roundup Ready
soybeans as they are tolerant to the proprietary herbicide, Roundup. The soybeans
were developed by Monsanto Ltd for cultivation in the United States. Soybeans
harvested from these plants have been imported into Australia, and presumably
New Zealand, since December 1996.
The parental soybean line A5403 was transformed with plasmid PV-GMGTO4 using
particle bombardment. Glyphosate-tolerant soybean line 40-3-2, which is the
subject of this application, was derived from the original transformant. This
transformation resulted in the transfer of the following genes: two CP4
5-enolpyruvyl shikimate-3ûphosphate synthase (EPSPS) genes fused to a petunia
EPSPS chloroplast transit peptide (CTP), the uidA gene and the nptII gene.
The CP4 EPSPS gene is derived from Agrobacterium sp. strain CP4. EPSPS is an
essential enzyme involved in the biosynthesis of the aromatic amino acids by the
shikimate metabolic pathway. This metabolic pathway is present in all plants,
bacteria and fungi. The mechanism of action of glyphosate is to inhibit this enzyme.
The Agrobacteriumûderived CP4 EPSPS has a reduced affinity for glyphosate,
therefore, its expression in the soybean is sufficient to compensate for the inhibition
of the endogenous EPSPS by glyphosate.
The uidA gene encodes the bacterial enzyme -glucuronidase (GUS) and is under the
control of the mannopine synthase promoter. This enzyme is used as a marker of
plant cell transformation. It converts the exogenously applied substrate,
5-bromoû4-chloro-3-indolyl -D-glucuronide, into a blue precipitate in the plant
cells in which the enzyme is expressed.
The nptII gene encodes the enzyme, neomycin phosphotransferase II and confers
resistance to the aminoglycoside antibiotics. This gene was used as a bacterial
selectable marker. The nptII gene is under the control of a bacterial promoter,
therefore, would not be expected to be expressed in the transformed plant cells.
Soybeans are imported for processing into vegetable oil, which is supplied to the
food industry, and protein meal, which is supplied to animal feed manufacturers
and, potentially, a small amount to the food industry. Local production of soybean
currently falls short of demand by approximately 50%.
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Date of authorization: 07/12/2000
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):
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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: Application A338 - Glyphosate tolerant soybean GTS 40-3-2
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
janet.gorst@foodstandards.gov.au
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Janet Gorst
Website:
Physical full address:
Boeing Building, 55 Blackall Street, Barton ACT 2600, Australia
Phone number:
+61 2 6271 2266
Fax number:
+61 2 6271 2278
Country introduction:

Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 120 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 15 staff) is located in Wellington on the North Island.

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)

Bolivia
Name of product applicant: Monsanto Argentina S.A.I.C
Summary of application:

Evaluation of the application of Monsanto, for the realization of field tests with transgenic soybean event 40-3-2

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Date of authorization: 07/04/2005
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):
Has completed the analysis of risk of introduction of soybean event 40-3-2, reaching the conclusion that: - The RR soybean event 40-3-2, has a gene in its genetic structure that confers resistance to the herbicide glyphosate. - Under natural conditions, cross-pollination and subsequent transfer of genetic material, can only occur among sexually compatible plants. - In Bolivia there are not sexually compatible species cultivated soybeans, making it unlikely the transfer of genes to wild populations. - The head of the resistance to the herbicide glyphosate, gene confers no additional adaptive advantage (ability to spread and capacity of establishment in the environment) to the RR soybean event 40-3-2 or its progeny, over conventional soy. - No scientific evidence found to substantiate the possibility that the cultivation of RR soya event 40-3-2, has the capacity to become a weed or that its behavior differs from conventional soybeans in the absence of applications of glyphosate herbicide. - The head of the resistance to the herbicide glyphosate, gene confers pest carecterísticas the RR soybean event 40-3-2 or its progeny.
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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:
marcevilela@hotmail.com
Organization/agency name (Full name):
Ministerio de Desarrollo Rural y Tierras
Contact person name:
Marcela Vilela Porcel
Website:
Physical full address:
Av. Camacho No. 1471 Piso 3; zona Central La Paz- Bolivia
Phone number:
591-2- 2111103 int 1
Fax number:
591-2-2113012
Country introduction:
Useful links
Relevant documents
Stacked events:

The country don’t have stacked events.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Brazil
Name of product applicant: Monsanto do Brasil Ltda.
Summary of application:
The National Technical Biosafety Committee (CTNBio) concluded in its 5th extraordinary meeting in 24th September 1998, the evaluation of biosafety (environment and food/feed) regarding the use in commercial scale of the soybean cultivar genetically modified "Roundup Ready". The technical conclusive report refers to genotypes derived from the soybean line GTS 40-3-2 or its progenies tolerant to the herbicide glyphosate, according to the request sent to CTNBio by the Monsanto do Brasil Ltda. (process # 01200.002402/98-60).
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Date of authorization: 24/09/1998
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.): Center for Environmental Risk Assessment
Summary of the safety assessment (food safety):
CTNBio concluded that there is no evidence of environmental risk or to the human or animal health from the use of the genetically modified soybean in question. This decision was based on the following elements: A.1. Environmental Elements: A.1.1. A. Soybean is a predominant self-pollinated plant species with an outcrossing rate of about 1.0%. Soybean is an exotic species without wild relatives that are sexually compatible in Brazil. Therefore, cross-pollination with wild species in the natural environment is not possible in the national territory. A.1.2. Soybean is a domesticated species and highly dependent on the human intervention for survival. Thus, there is no scientific reason to predict that the soybean lines derived from GTS 40-3-2 will survive outside the agricultural environment. Furthermore, without the selective pressure (glyphosate use) the expression of the inserted gene does not provide any adaptive advantage (increased fitness). A.1.3. The transgenic insertion is molecularly characterized. There was no observation of any pleiotropic effects from the transgenic insertion in studies conducted in many environments. A.1.4. There are at least three weed species known to be naturally tolerant to the glyphosate herbicide (Richardia brasiliensis, Commelina virginica, Spermacoce latifolia). The use of the herbicide for over two decades in Brazil did not cause the development of any other weed species tolerant to glyphosate. The introduction of cultivars tolerant to glyphosate will not increase the selection pressure over weeds in terms of the glyphosate concentration (product/area). A.1.5. There is no evidence that the routine utilization of the herbicide glyphosate in the soybean crop has any negative effect in the biological nitrogen fixation process. This observation is based on trials conducted by government and private Brazilian institutions, which indicated that the continued use of the herbicide did not affect nodulation of the soybean cultivars. The marker gene nptII that codes for kanamycin resistance was not transferred into the GTS 40-3-2 line. A.1.6. There is no indication that the use of the cultivars derived from the GTS 40-3-2 will lead to significant alterations in the profile and population dynamics of insects associated to the conventional soybean crop. A.2. Human and Animal Health Elements: A.2.1. CTNBio concluded that the introduction of the transgene does not alter the chemical composition of the soybean, with the exception of the transgenic protein CP4 EPSPS. This conclusion in the equivalence of the chemical composition is based on evaluations conducted by scientific methodologies, published in international scientific referee journals. The safety of the protein CP4 EPSPS regarding the toxicological and allergenic aspects were also proved. It is important to mention that the utilization of the transgenic soybean and products thereof in South, Central and North America, Europe, and Asia there is not even one case of allergic reaction of any human person that is not allergic to the conventional soybean. Also, it is important to consider that individuals sensible to conventional soybean will continue to be sensible to the transgenic soybean; therefore, they should not use this product. A.2.2. The analysis of the literature did not confirm any alleged increase in the allergenicity of the transgenic soybean in relation to the commercial cultivars. The scientific articles available and cited about the matter did not demonstrate an increase in the levels of the proteins reactive to the serum of a pool of individuals sensible to soybean (Burks and Fuchs, 1995; J. Aller. Clin. Immun. 96:1008-1010). The authors point out that: "our studies demonstrated that the introduction of the gene coding for the EPSPS protein to confer tolerance to glyphosate did not cause any noticed modification, qualitative or quantitative, in the composition of the endogenous allergenic soybean proteins in any of the cultivars resistance to glyphosate analyzed". B. Technical Conclusive Opinion: CTNBio approves the request submitted by the Monsanto do Brasil Ltda (Process 01200.002402/98-60), observing the determinations below: B.1. CTNBio determines the monitoring of commercial production areas of soybean cultivars derived from the breeding line GTS 40-3-2 for a period of five years with the objective to develop "compared studies" about the plant species, insects and microorganisms present in the fields. The verification of potential significant alterations to biosafety may result in the immediate suspension of the commercial production. B.2. The interested party (Monsanto) must make available areas for conducting and be responsible for the scientific monitoring to generate the complementary information, which will be supervised by technical experts nominated by the CTNBio. The information must be obtained in parallel to the commercial production of the crop. The areas, dimensions, location will be established in regions representative of the soybean growing areas in mutual agreement between CTNBio and Monsanto. B.3. The monitoring must include the following: B.3.1. Variation of the specific composition of the weed species community in the area, including the composition and magnitude of the seed reserve in the soil, as part of the evaluation; B.3.2. Incidence of escapes of weed species determining if this was a consequence of the transfer of the transgene. B.3.3. Periodic evaluation of the population dynamics of the organisms "indicadors": insects, pathogens, nitrogen fixing and phosphate solubilizing microorganisms B.3.4. Provide an annual technical report to the executive secretary of the CTNBio by June 15th, following the crop season B.4. The monitoring areas will be open to a scientific auditing by the organized society institutions interested, with a previous authorization of the CTNBio, in the presence of the Agricultural Ministry inspector. B.5. The interested party (Monsanto) must inform in the package of the product that the users of the new technology may have technical visits of CTNBio, in the terms defined above. C. The CTNBio declares its own rights to reevaluate this guidelines any time the committee considers needed under a justification, the lines of direction listed in item B. D. CTNBio understands that due to reasons of legal nature related to labeling and planting authorization, the commercial use of the transgenic soybean is still pending.
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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:
Molecular Traditional Methods
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: National Biosafety Commision
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Authorization expiration date (a blank field means there is no expiration date) not applicable
E-mail:
gutemberg.sousa@mcti.gov.br
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Edivaldo Domingues Velini
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556134115516
Fax number:
556133177475
Country introduction:
Useful links
Relevant documents
Stacked events:

At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio

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

Dr. Edivaldo Domingues Velini (President of national Biosafety Commission)

Canada
Name of product applicant: Monsanto Canada Inc
Summary of application:
Monsanto has developed alfalfa (Medicago sativa L.) lines based upon transformation events J101 and J163. Alfalfa varieties containing these events express the CP4 5-enolpyruvylshikimate-3-phosphate (cp4-epsps) gene which confers tolerance to glyphosate herbicides (trade name, Roundup®). Health Canada has previously indicated no objection to the sale of glyphosate tolerant corn (NK603, Mon 802, Mon 832), cotton (1445), canola (GT 200, GT 73) and soybean (GTS 40-3-2) lines for human food applications in Canada. Like alfalfa events J101 and J163 these lines express the CP4 EPSPS enzyme which confers tolerance to glyphosate herbicides

The safety assessment performed by Food Directorate evaluators was conducted according to Health Canada's Guidelines for the Safety Assessment of Novel Foods. The assessment considered: how alfalfa events J101 and J163 were developed; how the composition and nutritional quality of alfalfa varieties containing these events compare to non-modified alfalfa varieties; and what the potential is for alfalfa derived from lines containing these events to be toxic or cause allergic reactions.

The Food Directorate has a legislated responsibility for pre-market assessment of novel foods and novel food ingredients as detailed in Division 28 of Part B of the Food and Drug Regulations (Novel Foods). Foods derived from alfalfa lines containing events J101 and J163 are considered novel foods under the following part of the definition of novel foods: "c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that

the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism"
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Date of authorization: 28/07/2005
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 decision document weblinks
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Novel Foods Decision
Novel Feeds Decision
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Neil.Strand@hc-sc.gc.ca
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

Canada
Name of product applicant: Monsanto Canada Inc.
Summary of application:
The GTS 40-3-2 line of soybean (Glycine max L.) was developed through a specific genetic modification to be tolerant to the activity of glyphosate herbicide. The novel variety was developed from the A5403 soybean variety (Asgrow Seed Co.) by insertion of a gene encoding a glyphosate tolerant variant of the endogenous 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS). Glyphosate specifically binds to and inactivates EPSPS, which is involved in the biosynthesis of the aromatic amino acids tyrosine, phenylalanine and tryptophan. This enzyme is present in all plants, bacteria, fungi, but not animals, which do not synthesize their own aromatic amino acids. Thus, EPSPS is normally present in food derived from plant and microbial sources. The modified soybean line permits farmers to use glyphosate containing herbicides, such as Roundup®, for weed control in the cultivation of soybean.

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Date of authorization: 09/04/1996
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
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Novel Foods Decision
Novel Feeds Decision
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Neil.Strand@hc-sc.gc.ca
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

Japan
Name of product applicant: Monsanto Japan Ltd.
Summary of application:

Soybean tolerant to glyphosate herbicide (cp4 epsps, Glycine max (L.) Merr.).

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Date of authorization: 30/03/2001
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 the link below (in Japanese).
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Food safety assessment performed by Ministry of Health, Labour and Welfare of Japan (in Japanese)
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
fscj-secretariat@cao.go.jp
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,GOJ
Contact person name:
Emi Takagi
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:
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: Monsanto
Summary of application:
Please refer to uploaded document.
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Date of authorization: 19/09/2008
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 uploaded document.
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
biosafety@nre.gov.my
Organization/agency name (Full name):
Department of Biosafety Malaysia
Contact person name:
Dr. Anita Anthonysamy
Website:
Physical full address:
Dept of Biosafety, Ministry of Natural Resources and Environment, Level 1, Podium 2, Wisma Sumber Asli, No. 25, Persiaran Perdana, Precinct 4, 62574 Putrajaya
Phone number:
+60388861153
Fax number:
+60388904935
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.

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

Malaysian Department of Biosafety 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: biosafety@nre.gov.my. Url: www. biosafety.nre.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: fsq-division@moh.gov.my
Mexico
Name of product applicant: Monsanto Comercial, S.A. de C.V.
Summary of application:

Authorization by COFEPRIS: 05


The genetically modified soybean MON-Ø4Ø32-6, as described in the application, expresses the CP4 EPSPS protein which confers tolerance to the glyphosate herbicide.

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Date of authorization: 18/09/1996
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: MON-Ø4Ø32-6 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:
sortiz@conacyt.mx
Organization/agency name (Full name):
CIBIOGEM
Contact person name:
Dra. Sol Ortiz García
Website:
Physical full address:
San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number:
+52 (55) 5575-6878
Fax number:
Country introduction:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

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

Philippines
Name of product applicant: Monsanto Philippines
Summary of application:
Monsanto Philippines Inc. has developed a soybean line, Soybean 40-3-2, derived from the Soybean A5403, which expresses their proprietary Roundup-ReadyTM genes. The soybean line was developed to allow the use of glyphosate, the active ingredient in Roundup® herbicide, as a weed control option.

Soybean 40-3-2 was produced by inserting a modified 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) encoding gene from the soil bacterium Agrobacterium sp. strain CP4, which confers tolerance to glyphosate herbicide. Expression of the cp4 epsps gene in the plasmid used for transformation was regulated by an enhanced 35S promoter (E35S) from cauliflower mosaic virus (CaMV), a chloroplast transit peptide (CTP4) coding sequence from Petunia hybrida, and a nopaline synthase (nos 3') transcriptional termination element from Agrobacterium tumefaciens.
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Date of authorization: 19/07/2013
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Monsanto Philippines Inc. submitted an application to the Bureau of Plant Industry (BPI) requesting for biosafety permit under AO#8 Part 5 for Soybean 40-3-2 which has been genetically modified for herbicide resistance Roundup. Soybean 40-3-2 has been evaluated according to BPI’s safety assessment by concerned agencies of the Department of Agriculture (DA): [(Bureau of Animal Industry (BAI and Bureau of Agriculture, Fisheries and Product Standards (BAFPS)] and a Scientific Technical Review Panel (STRP). The process involves an intensive analysis of the nature of the genetic modification together with a consideration of general safety issues, toxicological issues and nutritional issues associated with the modified soybean. The petitioner/applicant published the said application in two widely circulated newspapers for public comment/review. BPI received no comment on the petition during the 30-day comment period. Review of results of evaluation by the BPI Biotech Core Team in consultation with DA-Biotechnology Advisory Team (DA-BAT) completed the approval process.
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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:
bpibiotechsecretariat@yahoo.com
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Merle B. Palacpac
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 521 1080
Fax number:
632 521 1080
Country introduction:

The Philippines is the first ASEAN country to establish a modern regulatory system for modern biotechnology. The country's biosafety regulatory system follows strict scientific standards and has become a model for member-countries of the ASEAN seeking to become producers of agricultural biotechnology crops. Concerns on biosafety in the Philippines started as early as 1987 when scientists from the University of the Philippines Los Banos (UPLB) and International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI) and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD) recognized the potential for harm of the introduction of exotic species and genetic engineering.

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Relevant documents
Stacked events:

Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.

 

Plant Products Carrying Stacked Genes Conferred Through (a) Genetic Engineering or b) Conventional Breeding, with Individual Traits That Have No Prior Approval:

A full risk assessnent as to  food and feed or processing shall be conducted,consistent with Part V of AO No. 8,"Approval Process For the Importation of Regulated Articles for Direct Use as Food and Feed or For Processing for plant products with multiple traits conferred through:

(a) genetic engineering, or

(b) conventional breeding, where the individual traits have no prior approval from the Bureau of Plant Industry (BPI) for direct use as food and feed or processing.

Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:

For plant products with multiple traits conferred through conventional breeding,with all individual events granted prior approval and included in the Approval Registry, a notlfication shall be submitted by the technology developer to the BPI, which shall conduct an evaluation in accordance with the relevant criteria in Annex I of this Memorandum Circular. The list of data contained in Annex I will not preclude the inclusion of other issues and concerns that will be raised by the BPI and the Scientific and Technical Review Panel (STRP) during the course of the desktop review.

Notificatlon Requirement for Plant Products Carrying Stacked Genes

All technology developers shall submit a notification to the Bureau of Plant Industry of their developed plant products carrying stacked genes and shall be required to comply with the relevant approval process listed above.

The Bureau of Plant Industry shall issue a certiflcate as to the approval of the stacked gene product and shall likewise include the transformation event in the official approval registry of plant products for food and feed or processing.

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

Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004

Republic of Korea
Name of product applicant: Monsanto Korea Ltd.
Summary of application:

Glyphosate herbicide tolerance

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Date of authorization: 24/06/2000
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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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:
mytrue85@korea.kr
Organization/agency name (Full name):
Ministry of Food and Drug Safety
Contact person name:
Website:
Physical full address:
Osong Health Technology Administration Complex, 187, Osongsaengmyeong 2-ro, Osong-eup, Cheongwon-gun, Chungcheonbuk-do, 363-700, Korea
Phone number:
82-43-719-2360
Fax number:
Country introduction:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Turkey
Name of product applicant: Special case: please show below
Summary of application:

Application for direct use as feed


Turkish Biosafety Law, entered in force in 2010, diverges from EU legislations in some points


 such as food and feed use require different separate applications, risk assessments and approvals.


  Addition, our Law forsees prision sentences in some circumtances of Law violation and joint


 reponsibilities for the violation. Therefore, GM product owners avoid to make application for approval and non product developer have made application till now. Instead, some Turkish assosiations  such as poultry producers assosiations, animal feed assosiations have applied to get approval for import of GM products for their members. Thus, name of product applicants are not product developers for our country.


Turkish Feed Manufacturer's Association

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Date of authorization: 26/01/2011
Scope of authorization: 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):
After the evaluation of reports released by Scientific Risk Assessment Committee and Socio- economic Assessment Committee Biosafety Board has approved the use of genetically modified soybean MON40-3-2 and products thereof for animal feed.
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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:
iozkan@tagem.gov.tr
Organization/agency name (Full name):
General Directorate of Agricultural Research and Policy
Contact person name:
İsa Özkan
Website:
Physical full address:
İstanbul Yolu üzeri, Tarım Kampüsü No:38 06171 Yenimahalle/Ankara/Turkey
Phone number:
+90 312 315 52 86
Fax number:
+90 312 315 26 98
Country introduction:

Turkey is party to the Cartagena Protocol on Biosafety (CPB) since Jan 24, 2004. Biosafety applications in Turkey are carried out within the framework of the Biosafety Law (no.5977) which entered into force in 26 September 2010 and its relevant regulations (“The Regulation on Genetically Modified Organisms and Products” and “The Regulation Connected with Working Procedure and Principles of Biosafety Board and Committees”). Biosafety Law and two regulations came into force on 26th September 2010. According to Biosafety Law it is forbidden to cultivate GM crops and animals, in Turkey. Biosafety Board founded in 22nd September 2010 to evaluate applications about GMO and products and perform tasks that are written in Biosafety Law and related regulations. Biosafety Board makes a “Decision” about applications on GMO and products via taking Scientific Committees’ risk assessment and socio-economic assessment into account. To date, 7 types of GM soybean and 25 types of GM maize were approved as feed for import.

 

For food, 29 different varieties (3 soybean, 21 maize, 3 oilseed rape, 1 sugar beet, 1 potato) has been applied and risk assessment for soybean and maize has been opened to public opinion. However, applicants withdrew due to the public pressure so Biosafety Board has not made any decision.

 

Biosafety Board makes a “Decision” about applications on GMO and products via taking Scientific Committees’ risk assessment and socio-economic assessment into account. Application evaluation process is like below:

  • Evaluation of application by Biosafety Board                              90 days
  • Feedback to the applicant                                                         15 days
  • Biosafety Board’s “Decision”                                                     270 days

(Starts from feedback to the applicant)

  • Establishing of Scientific Committees
  • Report preparation of Committees
  • Report’s public release
  • Evaluation of public opinions by Committees
  • Board’s final decision after taking reports and public opinions into account
  • Report’s presentation to Ministry by Board
  • Publishing the Positive Decision                                                30 days
  • Reclamation period to Negative Decision                                   60 days
  • Evaluation of reclamation by Board                                          60 days

 

Table 1: Decisions for GMO’s Depending on Usage

 

Usage

Positive

Negative

Date of desicion

Feed

3 GM soybean

-

Official   Gazette  no 27827 in  26 January    2011

Feed

16 GM maize

-

Official Gazette    no 28152 in  24 December 2011   (13 GM maize)

Official Gazette    no 28271 in  21 April 2012 (3 GM   maize)

Feed

-

6 GM  maize

13. Biosafety   Board Meeting decision

(26 March 2012)

Feed

-

3 GM oilseed rape

16. Biosafety   Board Meeting decision

(19 November 2012)

Feed

-

1 GM sugar beet

16. Biosafety   Board Meeting decision

(19 November 2012)

Bioetanol

-

22 GM maize

16. Biosafety   Board Meeting decision

(19 November 2012)

Feed

3 GM maize

-

Official   Gazette  no 29418 in  16 July 2015

Feed

2 GM soybean

-

Official   Gazette  no 29418 in  16 July 2015

Feed

2 GM soybean

-

Official   Gazette  no 29523 in  5 November 2015

Feed

6 GM maize

-

Official Gazette    no 29523 in  5 November 2015

 

 

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Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
United States of America
Name of product applicant: Monsanto Company
Summary of application:
Soybean
Trait 1 Added Protein: 5-Enolpyruvylshikimate-3-phosphate synthase (EPSPS)
Source: Agrobacterium sp. strain CP4
Intended Effect: Tolerance to the herbicide glyphosate
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Date of authorization: 27/01/1995
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 consult the FDA website at 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: FDA's webpage for this variety
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
jason.dietz@fda.hhs.gov
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.

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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:

Food and Drug Administration (premarkt@fda.hhs.gov); Environmental Protection Agency

Uruguay
Name of product applicant: Monsanto Co.
Summary of application:

The GTS 40-3-2 line of soybean (Glycine max L.) was developed through a specific genetic modification to be tolerant to the activity of glyphosate herbicide. The novel variety was developed from the A5403 soybean variety (Asgrow Seed Co.) by insertion of a gene encoding a glyphosate tolerant variant of the endogenous 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS). Glyphosate specifically binds to and inactivates EPSPS, which is involved in the biosynthesis of the aromatic amino acids tyrosine, phenylalanine and tryptophan. This enzyme is present in all plants, bacteria, fungi, but not animals, which do not synthesize their own aromatic amino acids. Thus, EPSPS is normally present in food derived from plant and microbial sources. The modified soybean line permits farmers to use glyphosate containing herbicides, such as Roundup®, for weed control in the cultivation of soybean.

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Date of authorization: 02/10/1996
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
Summary of the safety assessment (food safety):
Please refer to uploaded document
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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: Gabinete Nacional de Bioseguridad, Resoluciones
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
mibarra@mgap.gub.uy
Organization/agency name (Full name):
Ministerio de Ganadería, Agricultura y Pesca
Contact person name:
Mariela Ibarra
Website:
Physical full address:
Constituyente 1476, Piso 3, Of. 310. Montevideo, Uruguay
Phone number:
+598 2 4104155/59, I
Fax number:
+598 2 4198175
Country introduction:
The uruguayan regulatory framework includes safety assessments of food end feed, environmental risk asessment, risk management, and risk communication. The inter-ministerial National Biosafety Commission (GNBio) is the competent authority on biosafety of GMOs. Integrated by: The Minister of Agriculture, MGAP (chair); Minister of Health (MSP); Minister of Economy and Finance (MEF); Minister of Housing, Territorial Ordering and the Environment (MVOTMA); Minister of Foreign Affairs (MRREE); and Minister of Industry, Energy and Mining (MIEM). This commission is the last responsible to make decisions over a submitted request. It has the authority to define policies to be followed with respect to biosafety in all scopes of GMO application. Other committees of experts and scientists give support to decisones of GNBio through risk analysis of biotechnological products. The Commission for Risk Management (CGR) is composed by one delegate of each of the ministries represented within GNBio. This commission is also chaired by the representative of the Ministry of Agriculture. The CGR advises GNBio on GMO biosecurity issues; elaborates reference terms for risk assessments; manages the participation process; is responsible for follow-up and monitoring of authorized events. The Evaluation of Risk in Biosecurity (ERB) is composed of experts proposed by the CGR and designated by GNBio among specialists in the different areas of risk assessment. Is responsible for considering, on a case-by-case basis, the potential risks and benefits of each new biotech product; assure case-by-case risk assessment evaluation based on scientific methods; writes an operational plan (pre-report) of risk assessment according to CGR directives; advises CGR based on the results of the analysis of risk assessment, and provides information during the consultation process. The Institutional Articulation Committee (CAI) Is a committe of technical experts from different national public and research institutions, which performs technical risk assessment of new events; prepares a technical report. The group is coordinated by the ERB coordinator. It include different groups of assesment. The Ad hoc experts groups are technical-scientific specialists in different areas of knowledge related to the analysis and evaluation of risk on new GMO events like characterization and molecular identification of events (GAHCIM) and human and animal health (GAHSHA).
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Relevant documents
Stacked events:
Evaluation of the stacked events is focused on the possible interactions between the single events contained in the particular trait. Each staked component must have the individual risk assesment report.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
GNBio office. E-mail: bioseguridad@mgap.gub.uy; Adress: Constituyente 1476, Montevideo, Uruguay.