| Commodity: |
Soyabean / Soybeans |
| Traits: |
Glufosinate tolerance |
| Name of product applicant: |
Bayer |
| Summary of application: |
|
| Upload: |
|
| 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)
|
| Summary of the safety assessment (food safety): |
Please see the EU relevant links below. |
| Upload: |
|
| 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 ACS-GMØØ6-4. - Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003. Please see the EU relevant links below. |
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Opinion of the European Food Safety Authority
Method for Detection
Reference Material
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
2/9/2022 |
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 Crop Science |
| Summary of application: |
Resistance to Glufosinate Ammonium (GA) is conferred by the expression of the gene phosphinothricin acetyl transferase (pat), derived from Streptomyces viridochromogenes.
GA controls weeds through the inhibition of glutamine synthetase (GS), which produces the accumulation of phytotoxic levels of ammonia in the plant. GS is responsible for the synthesis of amino acid glutamine as from glutamic and ammonia acid. It is the only enzyme in the plant that can detoxificate the ammonia released by photo breathing, the reduction of nitrate and the degradation of amino acids. Ammonia, still a plant nutrient and a metabolite, is toxic in excess and produces the death of the plant cell.
Although GS of S. viridochromogenes is sensitive to an L-phosphinothricin, the bacteria produce an inactivating enzyme, PAT.
PAT catalyzes the conversion of L- phosphinothricin to N-acetyl-L-phosphinothricin in the presence of acetyl-CoA as a co-substrate. N-acetyl-L- phosphinothricin does not inactivate GS, and therefore it does not have an herbicide activity. As a consequence, plants that express the PAT enzyme are resistant to phosphinothricin herbicides.
The stability and the mendelian segregation of the event was demonstrated.
PAT is the new expressed protein with low levels in grains and in forage. Have not similarity with allergenic or toxic proteins and have rapid degradation in SGF (simulated gastric fluids).
The event A5547-127 is substantial and nutritionally equivalent to its non transgenic counterpart, the parental line (A5547) and conventional varieties.
|
| Upload: |
|
| Date of authorization: |
21/05/2008 |
| 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.): |
|
| 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: |
Principles for the Assessment of Food and Feed derived from GMO in Argentina - Resolution Nº 412
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Ministerio de Agroindustria
Contact person name: Andrés Maggi
Website:
Physical full address: Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number: 54 11 5222 5986
Fax number:
Country introduction: In Argentina, the food and feed risk assessment process of transformation events, as the result of modern biotechnology, is carried out by the National Service for Agrifood Health and Quality (Senasa). The General Office of Biotechnology, is the area responsible for carrying out this task. It has an specific professional team and the advise of a Technical Advisory Committee composed of experts from several scientific disciplines representing different sectors involved in the production, industrialization, consumption, research and development of genetically modified organisms. 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 Pty Ltd |
| Summary of application: |
The GM soybean variety is known commercially as LibertyLink soybeans. Bayer CropScience is seeking approval for two lines; line A2704-12 and line A5547-127. Only line A2704-12 is intended for commercialisation at this stage.
Soybean lines A2704-12 and A5547-127 have been genetically modified to be tolerant to the herbicide glufosinate ammonium. Glufosinate ammonium (also referred to as
phosphinothricin) is a non-selective, contact herbicide that provides effective post-emergence control of many broadleaf and grassy weeds. The mode of action of the herbicide is to inhibit the enzyme glutamine synthetase, an essential enzyme involved with ammonium accumulation and nitrogen metabolism in plants. The inhibition of glutamine synthetase results in an over accumulation of ammonia in the plant, which leads to cell death. Tolerance to glufosinate ammonium is conferred though the expression in the plant of the enzyme phosphinothricin acetyltransferase (PAT), encoded by the pat gene from the soil bacteria Streptomyces viridochromogenes. The production of PAT by soybean lines A2704-12 and A5547-127 enables the post emergence use of glufosinate ammonium herbicides without risk
of damaging the crop. The applicant has stated that development of GM glufosinate
ammonium tolerant soybeans will provide a selective use for glufosinate ammonium, creating a valuable new weed management tool for soybean producers.
Soybean lines A2704-12 and A5547-127 have been developed for cultivation in the major soybean producing countries of the world. The applicant has indicated that at present they have no plans to develop glufosinate ammonium tolerant soybeans for cropping in either Australia or New Zealand. Food from soybean lines A2704-12 and A5547-127 will therefore be entering the Australian and New Zealand food supply as imported, processed, food products only.
There are three major food products derived from soybeans – seeds, oil and meal. Whole soybeans are used to produce soy sprouts, baked soybeans, roasted soybeans, full fat soy flour and the traditional soy foods such as miso, tofu, soy sauce and soymilk. Soybean oil has many food uses including in cooking oils, mayonnaise, margarine, salad dressings, sandwich spreads, and shortenings. Soybeans are also processed into lecithin, an emulsifying agent (food additive) found in a wide variety of foods. Finished food products containing soybean ingredients therefore include beer, noodles, breads, flours, sausage casings, pastries, crackers, meat substitutes, milk substitutes and confectionery among other things.
Soybean lines A2704-12 and A5547-127 will be used in conventional breeding programs to produce soybean hybrids tolerant to glufosinate ammonium. LibertyLink soybeans have been cleared for food use in the United States, Canada, Japan, South Africa (A2704-12 only) and Russia. |
| Upload: |
|
| Date of authorization: |
29/04/2004 |
| 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): |
|
| Upload: |
|
| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
|
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Application A481 - 'LibertyLink' Glufosinate-ammonium Tolerant Soybean A2704-12 A5547-127
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Food Standards Australia New Zealand
Contact person name:
Website:
Physical full address: Level 4, 15 Lancaster Place, Majura Park ACT 2609, Australia
Phone number: +61 2 6271 2222
Fax number: +61 2 6271 2278
Country introduction: Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 115 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 10 staff) is located in Wellington on the North Island. 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 S.A |
| Summary of application: |
Commercial release of soybean, event A2704-12, styled Liberty Link Soybean (LL Soybean), for the purpose of free registering, using, conducting essays, testing, sowing, transporting, storing, marketing, consuming, importing, releasing into the environment and disposing. LL Soybean was developed by inserting in the plant a pat gene responsible for synthesizing enzyme phosphinothricin N-acetyltransferase (PAT), which catalyzes conversion of L-phosphinothricin (gluphosinate ammonium) into non-toxic products, inactivating the active ingredient and this way granting the plant the trait of tolerance to the herbicide. |
| Upload: |
|
| Date of authorization: |
11/02/2010 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
Center for Environmental Risk Assessment
|
| Summary of the safety assessment (food safety): |
event A2704-12, styled Liberty Link Soybean (LL Soybean), for the purpose of free registering, using, conducting essays, testing, sowing, transporting, storing, marketing, consuming, importing, releasing into the environment and disposing. LL Soybean was developed by inserting in the plant a pat gene responsible for synthesizing enzyme phosphinothricin N-acetyltransferase (PAT), which catalyzes conversion of L-phosphinothricin (gluphosinate ammonium) into non-toxic products, inactivating the active ingredient and this way granting the plant the trait of tolerance to the herbicide. Gene pat used was a modified version of a gene isolated from a soil-natural bacterium, Streptomyces viridochromogenes, and was inserted in the plant cells through a transformation process via biobalistics. The modification introduced in the pat gene was one of reducing, via site-directed mutagenesis, the content of G:C bases (frequent in bacteria genomes, yet atypical in plant genomes). The modifications conducted failed to modify the original sequence of PAT protein amino acids. The genetic elements present in the insert were pat gene, promoter 35S derived from Cauliflower Mosaic Virus (CaMV), and ƒÒ-Lactamase selection marker gene (ƒÒla) coming from Escherichia coli, which grants resistance to the antibiotic ampicillin. Plasmid vector used to replicate the insert was plasmid pB2/35SAcK derived from plasmid pUC19. The plasmid vector was linearized prior to the transformation process in order to deactivate gene ƒÒla coding sequence. Southern blot analyses showed that the LL Soybean genome contains two (2) copies of gene pat inserted in the genome of event A2704-12. A single copy of 3’ end fragment and a single copy of 5’ fragment of gene ƒÒla are present in the genome between the two pat cassettes and in inverted orientations, making expression of the antibiotic characteristic impossible. Stability of event A2704-12 for several generations was demonstrated by Southern blot analyses. The PAT protein is expressed in adequate intensity, enabling soybean A2704-12 to resist up to three times to the recommended amount of ammonium gluphosinate to be used in the field, being the only exogenous protein to be expressed in A2704-12 soybean. PAT protein was detected in low levels in plant tissues assayed (from 0.001% to 0.002% of total protein) and, as expected, no amount was detected in refined oil. Besides, it was shown that the protein is rapidly degraded in gastric and intestinal fluids, presenting great susceptibility to digestion and denaturation. In silico, in vitro and in animal analyses demonstrated that PAT protein fails to display allergenicity and toxicity. Assessment conducted by international organisms and data supplied by applicant demonstrated that the event failed to cause any harmful effect to both, the environment and non-target organisms, and that it fails to posses any other characteristic that may grant adaptive advantages. Evidence indicates that there is substantial equivalence, that is to say, transgenic LL plants are not fundamentally different from the non-transformed soybean genotypes, except for the tolerance to the herbicide ammonium gluphosinate. Regarding horizontal gene flow, it is practically impossible, since there are no feral kindred of soybean in the Brazilian territory. Besides, soybean is an autogamous plant, which makes vertical gene flow very difficult. A2704-12 soybean was approved for use in foods since 1998, in the United States; 2000, in Canada; 2002, in Japan; 2003, in Mexico; 2004, in Australia; 2007, in Taiwan; and 2009, in Korea and the Philippines. EFSA, the European Food Safety Authority reached a conclusion that products containing, or produced from, event A2704-12 fail to present any adverse effect to human or animal health, as well as to the environment, and the European Union approved imports of event A2704-12 for human and animal consumption in September 2008.
Although the issue is beyond the scope of CTNBio, it is worth stressing that gluphosinate ammonium is a non-systemic and non-selective herbicide, used mainly in the control of invading plants in post-emergence, both of large leave and narrow leave invaders, and is registered, approved and free to be marketed in Brazil by the Ministry of Agriculture and Supply (MAPA), IBAMA and the Ministry of Health, used in Brazil and several other countries to control pest plants, either with or without farming of transgenic plants resistant to the herbicide. The worldwide use of the herbicide relies on its biodegradability, low residual activity and low toxicity to humans, animals and other organisms of the food chain.
For the foregoing, the conclusion is that farming and consumption of Liberty Link Soybean (LL Soybean event A2704-12) is neither a potential cause of significant degradation of the environment nor a cause of risks to human and animal health. For the reasons above, there are no restrictions to the use of this soybean and its derivatives. Applicant shall submit a post-commercial release monitoring pursuant to CTNBio Ruling Resolution nº 5 within thirty days from publication of this Summary of Technical Opinion.
TECHNICAL OPINION
I. Identification of GMO
Name of GMO: Liberty Link Soybean, Event A2704-12.
Applicant: Bayer S.A.
Species: Glycine max L. Merr.
Inserted Characteristics: Tolerance to gluphosinate ammonium.
Method of insertion: Particle acceleration method (Biobalistics) in the soybean apical meristems, according to methodology described by Christou et al. (1988) and using previously fragmented plasmid pB2/35SAcK.
Proposed use: Free registration, using, essaying, testing, sowing, transporting, storing, commercializing, consuming, releasing, discarding and any other activities related to the GMO.
II. General Information
Soybean (Glycine max (L.) Merr) is a diploided tetraploid species (2n=40, belonging to family Leguminosae, subfamily Papilionoideae, tribe Phaseolae¸ genus Glycine, subgenus Soja.
Soybean is currently farmed in over 35 countries, being the United States, China, India, Argentina and Brazil the largest producers. Production of grains is targeted to several uses, such as oils (for margarines, salads, cooking), alimentary products including tofu, soy sauce, soymilk, soy meat (texturized protein). In addition, it is used as alimentary supplement in animal ration. Soybean has an extensive industrial use, ranging from production of antibodies to the use in soaps and disinfectants (OECD, 2000).
In Brazil, soybean is farmed in all regions, mainly in the Centre West (9.6 million hectares) and South (8.2 million hectares) (CONAB, 2005). Presence of weed (plant species different from the cultivated plant that are present in the cultivated area) is a limiting factor for soybean farming, leading to a loss ranging from 42% to 62% in Brazil. This way, controlling weed is very important in soybean farming and is conducted mainly by chemical ways, with the use of herbicides. Use of plants genetically modified for tolerance to herbicides has been important in managing pests in commercial cultivation of large cultures. All over the world, the area cultivated with tolerant soybean reached, in 2008, about 65.9 million hectares. Since 1998, genetically modified glyphosate tolerant (Roundup Ready Monsanto) soybean is extensively farmed in Brazil. About 65% of soybean produced in Brazil was RR® transgenic, representing 21.9 million hectares. Up to this moment, no harmful effect to the environment has been reported due to gene flow caused by this GMP.
However, massive use a same herbicide for consecutive crops, as the case of glyphosate, accelerates the process of invading plants that are naturally resistant to the herbicide (Owen, 2008). In this sense, the possible use of genetically modified soybean varieties that display resistance to another insecticide, such as the ammonium gluphosinate, represents an important tool for managing invaders, making increased longevity of such technologies possible. Soybean event A2704-12 plants display sensitiveness to other herbicides, such as glyphosate, indicating the substratum specificity of PAT protein and demonstrating that plants of this event may be managed by techniques usually used to eradicate undesired plants in the fields.
III. Description of the GMO and Proteins Expressed
Event A2704-12, styled LibertyLink Soybean, presents gene pat derived from a non-pathogenic soil bacterium (Wohlleben et al. 1992; Hérouet et al, 2005), Streptomyces viridochromogenes, which grants tolerance to herbicide gluphosinate ammonium. This exogenous gene codes for enzyme phosphinothricin N-acetyltransferase (PAT protein) that promotes inactivation of the herbicide. The nucleotide sequence of gene pat inserted in the soybean was modified, by site-directed mutagenesis, with the purpose of reducing the contents of G:C bases (frequent in bacterium genomes but atypical in plants) ensuring high expression of PAT protein. The modifications conducted failed to change the original sequence of the PAT protein amino acids.
Gene pat was replicated using plasmid pB2/35SAcK and the nucleotide sequence was inserted in the genome through particle acceleration technique. The plasmid displayed gene pat, promoter and terminator 35S (derived from Cauliflower Mosaic Virus (CaMV) and marker gene ƒÒla (resistance to antibiotic ampicillin).
Gene ƒÒla (ƒÒ-lactamase derived from Escherichia coli) that is present in the plasmid vector, was fragmented by restriction enzyme prior to the event insertion.
Southern blot hybridizations and amplifications by DNA-polymerase chain reaction were presented to demonstrate integration of the exogenous DNA fragment to the plant genome, the number of gene copies, presence or absence of other DNA elements and location of transgene parts. The results submitted indicate that event A2704-12 has two copies of gene pat and two non-functional fragments of gene ƒÒla. The event has a gene ƒÒla fragment copy of the 3’end and a copy of the 5’end. However, ƒÒla fragments are unable to reconstitute the gene for they are invertedly oriented, making its expression impossible. The construct inserted in the soybean genome fails to present sequences associated to mobility in the genome.
Homology analyses in event A2704-12 demonstrated that 2566 bp, of regions 5’-flanking 4044 bp, originated from the soybean chloroplast DNA and that the remaining sequences (1478 bp) originated from the soybean genomic DNA. Besides, 3430 bp of the pre-insertion site were amplified and sequenced, revealing deletion of 2082 bp of soybean genomic DNA in the transformation event site of insertion (Moens & Habex, 2006). The company attributed deletion and presence of chloroplast DNA sequence in the soybean genome to the biobalistics technique used. According to the results presented, the modifications failed to cause changes in aspects related to human and animal health and environment safety, as indicated by the studies described in the application for Commercial Release.
The characteristic of resistance to the gluphosinate ammonium herbicide followed the Mendelian way in this event, regarding generations assayed by applicant, indicating genetic stability of the insert. Likewise, Southern blot analyses demonstrate that DNA samples of event leaves coming from three generations show no difference in their band patterns, indicating that the insert is genetically stable.
Enzyme PAT is the only protein expressed by the transgene; it has 183 amino acids and molecular weight of 22 kDa. Plants of this event display 2.23 ƒÝg/g PAT protein in roots, 7.63 ƒÝg/g in stalks, 14.5 ƒÝg/g in leaves, and 1.66 ƒÝg/g in seeds (AgBios, 2009). Protein PAT failed to be identified in refined oil and lecithin fraction of the samples assayed. Though presence of PAT activity had been detected in peels and seeds, no activity was detected in soybean meal (AgBios, 2009). On average, contents of PAT protein in soybean A2704-12 fodder and straw are 0.0026% and 0.0012% respectively (Shillito, 1998). Although seeds present the lowest levels of PAT, averaging 0.00029% for event A2704-12 against the content of gross protein, the levels show high variation, ranging from 0.593 ƒÝg/g to 11.5 ƒÝg/g of fresh weight, according to location and cultivar.
IV. Aspects Related to Human and Animal Health
There is no available evidence indicating that PAT protein is toxic to human beings and other animals (OECD, 1999). Besides, data demonstrating the absence of acute oral toxicity of PAT protein in rats were assayed by FSANZ (2000) in a number of preceding occasions, where the conclusion was that the protein is atoxic to animals and humans (FSANZ, 2000, 2001a, b, 2003). Likewise, the conclusion applies to PAT protein present in A2704-12 soybean, since it is identical in the amino acid sequence to the PAT protein assessed in previous occasions.
To assess PAT protein similarity with other known toxins, sequence tests by amino acid homology were conducted with all current sequences of protein on the following reference databases: Swiss Prot, trEMBL, GeneSeq-Prot, PIR, PDB, DAD and GenPept. BLASTP program was used to compare PAT protein amino acids sequence with all available sequences in the different databases. No relevant similarity between PAT protein and known toxins was found. As expected, similarities were observed with other PAT proteins of different origins.
There is great interest in knowing whether new proteins introduced in food may cause allergic reactions to some individuals. Potential allergenicity of a new protein shall be assayed by a combination of different criteria, since no individual criterion is sufficient as a prevision character to allergenicity or non-allergenicity. The assessment concentrated on the study of amino acid similarity between the new protein and proteins containing known allergens, including structural properties and susceptibility to degradation by simulated digestion. Application of such criteria on a systematic way provides reasonable evidence on the potential of recently introduced proteins to act as allergen (Leher & Reese, 1998; Jones & Maryanski, 1991). PAT is the only new protein expressed in A2704-12 soybean. Therefore, this protein was assessed using these criteria for a possible allergenicity potential. PAT protein amino acid sequence was compared with the epitopes found in known allergens, present in available databases (SwissProt, trEMBL, GeneSeq-Prot, PIR, DAD and GenPept), with the purpose of identifying any amino acid sequence that might represent an isolated allergenic epitope. The criterion indicating allergenicity was one hundred percent identity to an allergen protein in a window size of eight amino acids. Results of the search failed to show such identity with known allergens.
Allergens commonly present in foods originated in plants are in general glycosylated proteins and, in their majority, tolerant to denaturation by heat remaining stable during the high temperatures involved in food cooking or processing. Studies determined that the enzyme is not heat resistant and is fully inactivated by temperatures over 75 ºC. Regarding in vitro digestibility, the majority of allergens normally present in food resist to peptic and acid conditions of the digestive tract, reaching and passing through the intestine mucosa to initiate an allergic response (Kimber et al., 1999; Astwood Fuchs, 1996; Metcalfe et al., 1996). A large number of studies was conducted with PAT protein to determine its potential as a toxic and allergenicity agent. The studies demonstrated that the protein is non-toxic to mammals, including humans. PAT protein was investigated for digestibility in models simulating digestion. Two studies were conducted: one recording PAT protein digestion in fluid digestibility (SGF) and the other simulating intestinal liquid (SIF). SGF contained pepsin and SIF contained pancreatin, a mixture of enzymes including amylase, trypsin, lipases, ribonuclease and protease. PAT extracted from ammonium gluphosinate tolerant corn leaves was treated with SGF and was rapidly digested (less than five seconds). No degradation took place in SGF in absence of pepsin. Pure PAT in SIF was digested within fifteen minutes. Besides those tests, Wehrmann et al. (1996) described that when protein PAT was tested in the presence of conditions simulating gastric juice, it was digested within seconds. Studies conducted by Esdaile (2002) demonstrate that the protein was digested within thirty seconds when incubated in the presence of gastric juice.
Summarizing, PAT protein has the following characteristics:
1. Has no homology with allergenic protein, toxin or nutrients;
2. Fails to display any glycosylation site (present in several allergenic products);
3. The protein is structurally unstable in acid environments;
4. It degrades and denatures rapidly in gastric and intestinal fluids of humans and domestic animals;
5. The protein has substrate-specific activity (acts solely on the GA compound and has no activity on glutamate amino acid);
6. Failed to show any adverse effect on mammals, even when high doses are administered in the vein;
7. The protein accumulates mainly in the seeds at very low levels, ranging from 0.003% to 0.0029% of total proteins. Protein levels were not affected when the culture was sprayed with ammonium gluphosinate herbicide.
Based on compositional assay involving analyses of total proteins, fat acids, fibers, carbohydrates, ashes, minerals (Ca, P, K, Fe, Mg, Zn), one may assert that insertion of the pat gene failed to change Event A2704-12 compositional tenor of Event A2704-12 as compared to its non-modified equivalent.
A2704-12 soybean is approved for use in foodstuffs since 1998 in the United States; 2000, in Canada; 2004, in Australia; 2002, in Japan; 2009, in Korea; 2003, in Mexico; 2009, in the Philippines; and 2007, in Taiwan. The European Unit approved its import for human and animal consumption in September 2008.
V. Environmental Aspects
Soybean is a predominantly autogamic species, with crossed pollination rates below 1.0% (Sediyama et al., 1999; Borém, 2000). A paper involving pollen dispersion in Brazilian cerrado (Abud et al., 2003) records that crossed pollination rate is 0.45% at a distance of 0.5 m, 0.14% at 1.0 m and does not occur in detectable form at a distance of 6.5 m. Besides, soybean is an exotic species, originating from China with no sexually compatible feral kindred in Brazil. Therefore, crossed pollination with sylvan species in the natural environment is not possible to occur in the national territory.
Soybean is a domesticated species, highly dependent from humans for its survival. Therefore, there are no reasons to foresee survival of A2704-12 soybean outside farming environments. Besides, in the absence of selective pressure (use of the herbicide), expression of the gene grants no adaptive advantage.
Plants derived from A2704-12 event displayed the same agronomic and adaptability behavior than conventional lineage, without changing survival regulation and species reproduction characteristics. Comparative analyses of morphologic, phenotypic and agronomic characteristics enabled a conclusion that none of such variables has been affected as a result of genetic modification (Freyssinet, 2002). No characters were recorded that may grant either selective advantage or atypical behavior to the species.
According to applicant, experiments conducted in the United States and Porto Rico, involving visual observations along the evolution cycle to assess occurrence of atypical plants or plants responding differently to biotic pressure, indicate that insertion of the pat gene has not affected susceptibility/resistance to plagues and diseases of lineages derived from event A2704-12, even when subjected to different environmental conditions. Studies conducted in Paulínia, State of São Paulo, and São Gabriel do Oeste, State of Mato Grosso do Sul, failed to record abnormality in terms of occurrence of insects and fungi, and related to plant physiology. Post-harvest monitoring conducted in experimental areas recorded little soybean remaining plants, which were easily eliminated. This demonstrates that the GMP does not remain in the farm environment without human intervention and fails to display characteristics that would make it more aggressive or invading in the ecosystem than its conventional parental.
Ammonium gluphosinate (AG) is a synthetic compound corresponding to phosphinothricin, which is naturally produced by some soil microorganisms, and is duly registered and regularly traded in Brazil under the brand FINALE. Other brands (LIBERTY, BASTA, IGNITE) are of international use. AG biodegradability is one of the main characteristics of the product, in addition to its low toxicity to birds, insects, earthworms, fish and bees, among others. AG is neither mutagenic nor carcinogenic and has low risk of leaving residues in soil and water due to its short half-life. Herbicide gluphosinate is rapidly degraded in soil by action of microorganisms that use this molecule as a source of nitrogen, liberating CO2 and phosphorus. Soils maintained in laboratory conditions demonstrated that, at a temperature of 20 ºC, gluphosinate has a half-life of 10 days (Smith, 1988; OECD, 2002). According to Hoerlein (1994), this synthetic phosphinothricin (ammonium gluphosinate) is not toxic to fungi, nematodes and insects, yet has a large range action against monocotyledons and dicotyledons, post-emergent and having very rapid effect in controlling plants since emergence from soil to more advanced phases. GA activity in the target plant is exclusive and specific (inhibition of glutamine synthetase enzyme), acting in a way to minimize appearance of resistant plant pest populations.
VI. Restrictions to the use of GMO and its derivatives
Studies submitted by applicant demonstrated an absence of significant difference between genetically modified soybean and its conventional isoline in what regards agronomic characteristics, means of reproduction, dissemination and survival ability. All evidence presented in the proceeding and bibliographic references confirm the transgenic variety level of risk as equivalent to that of the non-transgenic regarding soil microbiota, other plants and human and animal health. Therefore, farming and consumption of A2704-12 soybean are neither a potential cause of significant environment degradation nor the origin of risks origin for human and animal health. These are the reasons to release this soybean and its derivatives from restrictions, except in locations mentioned by Law nº 11,460, of March 21, 2007.
VII. Considerations on particulars of different regions of the country (assistance to monitoring bodies):
As established in Article 1 of Law nº 11,460, of March 21, 2007, “research and cultivation of genetically modified organisms are forbidden in indigenous and conservation unit areas”.
VIII. Conclusion
The conclusions are that:
• Soybean is a domesticated species, highly dependent from the human species for its survival and, therefore, there are no scientific reasons to foresee survival of plants derived from lineage A2704-12 outside farming environments;
• Soybean is an exotic species, with no sexually compatible sylvan kindred in Brazil and crossed pollination with wild species in the natural environment may not occur in the Brazilian territory;
• Molecular analysis of A2704-12 soybean evidenced that integrity and stability of the insert was maintained;
• Analyses of segregation and genetic inheritance pattern are stable along successive generations;
• Agronomic and efficacy assessments of A2704-12 soybean indicate that the insertion failed to lead to expression of any other characteristics than expected, namely tolerance to herbicide ammonium gluphosinate (AG), and that the GMP has the same agronomic and adaptability behavior than the conventional lineage, with no change of the characters that regulate the species survival and reproduction;
• Herbicide gluphosinate is rapidly degraded in soil by action of microorganisms that use this molecule as a nitrogen source, liberating CO2 and phosphorus;
• AG is a synthetic compound corresponding to phosphinothricin, produced in nature by some soil microorganisms;
• Protein PAT has homology to no allergenic or toxic protein;
• Protein PAT fails to display significant risk for human and animal health and to the environment according to oral acute toxicity and in vitro digestibility studies;
• Foodstuffs based on soybean derived from Event A2704-12 have compositional/nutritional equivalence to products originating from non-modified soybean varieties;
• Environmental safety aspects were analyzed in local field studies where it was shown that the lineage coming from Event A2704-12 does not negatively affect survival of other plants and animals.
For the foregoing and taking provisions of Article 14 of Law nº 11,105, CTNBio holds that the request complies with applicable rules and legislations in effect aimed at securing environment, agriculture, and human and animal health biosafety, and concludes that Liberty Link Soybean (Event A2704-12) is substantially equivalent to conventional soybean and that its consumption is safe to human and animal health. Regarding the environment, |
| Upload: |
|
| 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 Comission
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
Not Applicable |
E-mail:
Organization/agency name (Full name): National Biosafety Technical Commission
Contact person name: Paulo Augusto Viana Barroso
Website:
Physical full address: SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number: 556120335087
Fax number:
Country introduction: Brazil had the first biosafety law approved in 1995. After the identification of the need to improve the biosafety system of Brazilian genetically modified organisms, a new law was published. The Law 11.105 / 05 establishes a technical committee dedicated to the analysis of the safety aspects of genetically modified organisms and a council of ministers that is dedicated to the analysis of the socioeconomic aspects of the commercial release of genetically modified organisms. In this context, Brazil already has several commercial products that involve genetically modified organisms (plants, human and veterinary vaccines, microorganisms for fuel production) and products derived from new genetic modification techniques. 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. Paulo Augusto Viana Barroso (President of national Biosafety Commission)
| Name of product applicant: |
Bayer CropScience Canada |
| Summary of application: |
The soybean lines A2704-12 and A5547-127 were developed through a specific genetic modification to be tolerant to glufosinate ammonium. The soybean plants have been transformed with a bacterial gene, phosphinothricin -N-acetyltransferase (PAT), that confers resistance to the glufosinate ammonium herbicides. The soybeans will be used in the same food applications as conventional soybeans.
|
| Upload: |
|
| Date of authorization: |
20/11/2000 |
| 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
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Health Canada
Contact person name: Neil Strand
Website:
Physical full address: 251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number: 613-946-1317
Fax number:
Country introduction: Federal responsibility for the regulations dealing with foods sold in Canada, including novel foods, is shared by Health Canada and the Canadian Food Inspection Agency (CFIA). Health Canada is responsible for establishing standards and policies governing the safety and nutritional quality of foods and developing labelling policies related to health and nutrition. The CFIA develops standards related to the packaging, labelling and advertising of foods, and handles all inspection and enforcement duties. The CFIA also has responsibility for the regulation of seeds, veterinary biologics, fertilizers and livestock feeds. More specifically, CFIA is responsible for the regulations and guidelines dealing with cultivating plants with novel traits and dealing with livestock feeds and for conducting the respective safety assessments, whereas Health Canada is responsible for the regulations and guidelines pertaining to novel foods and for conducting safety assessments of novel foods.
The mechanism by which Health Canada controls the sale of novel foods in Canada is the mandatory pre-market notification requirement as set out in Division 28 of Part B of the Food and Drug Regulations.
Manufacturers or importers are required under these regulations to submit information to Health Canada regarding the product in question so that a determination can be made with respect to the product's safety prior to sale. The safety criteria for the assessment of novel foods outlined in the current guidance document (i.e. Canadian Guidelines for the Safety Assessment of Novel Foods) were derived from internationally established scientific principles and guidelines developed through the work of the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organisation (FAO), World Health Organisation (WHO) and the Codex Alimentarius Commission. These guidelines provide for both the rigour and the flexibility required to determine the need for notification and to conduct the safety assessment of the broad range of food products being developed. This flexibility is needed to allow novel foods and food products to be assessed on a case-by-case basis and to take into consideration future scientific advances. 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: |
|
| Upload: |
|
| Date of authorization: |
19/08/2014 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
|
| Summary of the safety assessment (food safety): |
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. |
| Upload: |
|
| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
|
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Ministerio de salud y proteccion social
Contact person name: Daniel Rubio
Website:
Physical full address: Carrera 13 No. 32- 76 piso 12, Bogotá
Phone number: 330 5000 ext 1256
Fax number:
Country introduction: The 4525 decree of 2005, established the Ministry of Health and Social Protection as the competent authority for GMO for health and food purposes and creates the National Biosafety Technical Committee for GMO's used in health and food purposes (CTNSalud).
The CTNSalud is composed by the Ministry of Health and Social Protection, the National Food and Drug Surveillance Institute (INVIMA) and the Technology and Innovation Administrative Department (COLCIENCIAS). This committee is responsible for the assesment of risk assessments; to inquire for any additional information; assessment of any measurements in accordance to the Cartagena Protocol; and the recommendation for the authorization of GMO for health or food purposes. 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: |
BASF Química Colombiana S.A |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
10/06/2020 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
|
| Summary of the safety assessment (food safety): |
Based on the risk assessment, it can be concluded that the event shows the same risks as its conventional counterpart. Therefore, the National Technical Committee for GMO use exclusively in health and human consumption (CTNSalud) recommends its authorization.
|
| Upload: |
|
| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
|
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Ministerio de salud y proteccion social
Contact person name: Daniel Rubio
Website:
Physical full address: Carrera 13 No. 32- 76 piso 12, Bogotá
Phone number: 330 5000 ext 1256
Fax number:
Country introduction: The 4525 decree of 2005, established the Ministry of Health and Social Protection as the competent authority for GMO for health and food purposes and creates the National Biosafety Technical Committee for GMO's used in health and food purposes (CTNSalud).
The CTNSalud is composed by the Ministry of Health and Social Protection, the National Food and Drug Surveillance Institute (INVIMA) and the Technology and Innovation Administrative Department (COLCIENCIAS). This committee is responsible for the assesment of risk assessments; to inquire for any additional information; assessment of any measurements in accordance to the Cartagena Protocol; and the recommendation for the authorization of GMO for health or food purposes. 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: |
PT. BASF Indonesia |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
21/07/2020 |
| 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.): |
Indonesia Biosafety Clearing House
|
| Summary of the safety assessment (food safety): |
Indonesian National Agency of Drug and Food certified food safety for GM Soybean event A5547-127 (tolerance to Glufosinate) |
| Upload: |
|
| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
|
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Indonesian Agency for Agricultural Research and De
Contact person name: Sustiprijatno
Website:
Physical full address: BB Biogen Jl Tentara Pelajar 3A Bogor 16111 Indonesia
Phone number: +622518333440
Fax number: +622518334420
Country introduction:
- Indonesia has ratified Protocol on Biosafety to the Convention on Biological Diversity (CBD) through the Indonesian Law No. 21 / 2004. In the implementation, biosafety assessment for GM products, based on Goverment Regulation Number 21 /2005, Indonesia has regulated GM products on several items including : product kinds and requrements, research and developement, product importation, product assessment, release and distribution, supervision and monitoring, and institution and financing. We have also Law for food No. 18 /2012 which also consists of regulation for GM food.
- Indonesia already have procedure /application on GMO biosafety assessment and National Authorized Institution who conducting the biosafety assessment . Each GM food should have authorization from Goverment before it can be released and distributed. An application for authorisation for new GM food should be submited to Biosafety Commision through related Ministry or authorised Non Departement Goverment Agency (LPND) . Biosafety Commision, then sends the application to the National Agency for Drug and Food Control (Badan POM) for technical team to evaluate the GM food safety. The recommendation by technical team will be sent back to Biosafety Commision. The recommendation and GM Food safety certificate will be released by Biosafety Commision to the applicant through related ministry or LPND.
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: National Agency of Food and Drug Control (BPOM): http://www.pom.go.id/new/home/en
| Name of product applicant: |
Bayer CropScience |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
28/01/2019 |
| 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): |
Competent National Authority: Ministry of Health and Medical Education- Food & Drug Administration. Risk Assessment file is uploaded.
https://bch.cbd.int/en/database/RA/BCH-RA-IR-115209/1 |
| Upload: |
|
| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
|
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): ABRII
Contact person name: Gholamreza Salehi Jouzani
Website:
Physical full address: Agricultural Biotechnology Research Institute of Iran (ABRII), Mahdasht Road, 31535-1897, Karaj, Iran
Phone number: 0098(26)32701132
Fax number: 0098(26)32701132
Country introduction: Iran has ratified Cartagena Protocol on Biosafety in 2003. The National Biosafety Law has also been ratified in 2009. The regulations for the National Biosafety Law have been prepared and approved during last ten years. All these laws and regulations deal with Living GMOs (LMOs) and there is no Law for the regulation of the non-living GMOs. All these laws and regulations are accessible at: http://bch.cbd.int/database/results?searchid=622770. Codex principles for the risk analysis of foods derived from modern biotechnology and other guidelines such as the Codex guidelines for the conduct of food safety assessment of foods produced using recombinant-DNA plants and microorganisms are widely accepted and used.
The process for authorization of new LMO release includes comprehensive risk assessment and management analysis. Ministry of Agriculture (Jihade Keshavarzi) is responsible for approval of the release, import, export, transit and use of Agricultural Related LMOs. The requests should be forwarded to: a[email protected]; with a CC to National Focal Point: [email protected]. Cartagena Protocol on Biosafety National Focal Point is in charge of all liaison affairs related to the Cartagena Protocol on Biosafety and acts as the contact point for the communications received. The Ministry of Health and Medical Education is in charge with the approval of all LMOs related to food and medicine. Environmental Protection Organization is in charge with the environmental release of LMOs in the wild nature and/or related to the wild organisms. Detailed procedure for authorization of GM food and feed is under preparation. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
|
Agricultural Jihad Ministry
Tehran, Tehran
Iran (Islamic Republic of)
|
|
Ministry of Health and Medical Education- Food & Drug Administration
Food and Drug Administration, Fakhrerazi St., Enghelab Ave.
Tehran
Iran (Islamic Republic of), 1314715311
|
| Name of product applicant: |
Bayer CropScience |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
24/04/2016 |
| 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): |
Competent National Authority: Ministry of Health and Medical Education- Food & Drug Administration. Risk Assessment file is uploaded.
https://bch.cbd.int/en/database/RA/BCH-RA-IR-114062/2 |
| Upload: |
|
| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
|
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): ABRII
Contact person name: Gholamreza Salehi Jouzani
Website:
Physical full address: Agricultural Biotechnology Research Institute of Iran (ABRII), Mahdasht Road, 31535-1897, Karaj, Iran
Phone number: 0098(26)32701132
Fax number: 0098(26)32701132
Country introduction: Iran has ratified Cartagena Protocol on Biosafety in 2003. The National Biosafety Law has also been ratified in 2009. The regulations for the National Biosafety Law have been prepared and approved during last ten years. All these laws and regulations deal with Living GMOs (LMOs) and there is no Law for the regulation of the non-living GMOs. All these laws and regulations are accessible at: http://bch.cbd.int/database/results?searchid=622770. Codex principles for the risk analysis of foods derived from modern biotechnology and other guidelines such as the Codex guidelines for the conduct of food safety assessment of foods produced using recombinant-DNA plants and microorganisms are widely accepted and used.
The process for authorization of new LMO release includes comprehensive risk assessment and management analysis. Ministry of Agriculture (Jihade Keshavarzi) is responsible for approval of the release, import, export, transit and use of Agricultural Related LMOs. The requests should be forwarded to: a[email protected]; with a CC to National Focal Point: [email protected]. Cartagena Protocol on Biosafety National Focal Point is in charge of all liaison affairs related to the Cartagena Protocol on Biosafety and acts as the contact point for the communications received. The Ministry of Health and Medical Education is in charge with the approval of all LMOs related to food and medicine. Environmental Protection Organization is in charge with the environmental release of LMOs in the wild nature and/or related to the wild organisms. Detailed procedure for authorization of GM food and feed is under preparation. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
|
Agricultural Jihad Ministry
Tehran, Tehran
Iran (Islamic Republic of)
|
|
Ministry of Health and Medical Education- Food & Drug Administration
Food and Drug Administration, Fakhrerazi St., Enghelab Ave.
Tehran
Iran (Islamic Republic of), 1314715311
|
| Name of product applicant: |
Bayer Crop Science Ltd. |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
08/07/2002 |
| 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). |
| Upload: |
|
| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
|
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Food safety assessment performed by Ministry of Health, Labour and Welfare of Japan (in Japanese)
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Food Safety Commission Secretariat,Cabinet Office,
Contact person name: 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: |
BASF (Malaysia) Sdn. Bhd. |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
11/02/2014 |
| 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.): |
Department of Biosafety Malaysia
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: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Department of Biosafety Malaysia
Contact person name: Dr. Anita Anthonysamy
Website:
Physical full address: Department of Biosafety,
Ministry of 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, Environment and Climate Change 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: |
Bayer CropScience Pty Ltd |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
22/07/2004 |
| 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): |
Food from soybean lines A2704-12 and A5547-127 has been evaluated according to the safety assessment guidelines prepared by FSANZ. The safety assessment included the following: • a detailed characterisation of the genetic modification to the plant; • a consideration of the safety of any transferred antibiotic resistance genes; • characterisation of any novel proteins, including their potential toxicity and allergenicity; • a consideration of the composition and nutritional adequacy of the food, including whether there had been any unintended changes to the food. The applicant submitted a comprehensive data package in support of their application and provided studies on the molecular characterisation of lines A2704-12 and A5547-127, the potential toxicity and allergenicity of PAT, compositional analyses of food derived from lines A2704-12 and A5547-127, and animal feeding studies to demonstrate the nutritional adequacy of the food. In addition to information supplied by the applicant, the evaluation also had regard to other available information and evidence, including from the scientific literature, general technical information, other regulatory agencies and international bodies. No potential public health and safety concerns were identified in the assessment of food from soybean lines A2704-12 and A5547-127. Therefore, on the basis of all the available evidence, including detailed studies provided by the Applicant, it has been concluded that food derived from soybean lines A2704-12 and A5547-127 is as safe and wholesome as food derived from other soybean varieties. |
| Upload: |
|
| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
|
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Application A481 - 'LibertyLink' Glufosinate-ammonium Tolerant Soybean A2704-12 A5547-127
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Ministry for Primary Industries
Contact person name: 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: |
Bayer CropScience Inc |
| Summary of application: |
Bayer CropScience Inc. has filed an application with attached technical dossiers to the Bureau of Plant Industry on April 26, 2016 for a biosafety permit for direct use as food, feed or for processing under the DOST-DA-DENR-DOH-DILG Joint Department Circular No. 1 series of 2016 (JDC No.1 s2016).
In accordance with Article VII. Section 20 of the JDC, no regulated article, whether imported or developed domestically, shall be permitted for direct use as food and feed, or for processing, unless: (1) the Biosafety Permit for Direct Use has been issued by the BPI; (2) in the case of imported regulated article, the regulated article has been authorized for commercial distribution as food and feed in the country of origin; and (3) regardless of the intended use, the regulated article does not pose greater risks to biodiversity, human and animal health than its conventional counterpart.
The BPI Biotech Office provided the assessors, except for the SEC expert, the complete dossier submitted by Bayer.
Extensive safety evaluation of A5547-127 in terms of genetic stability, agronomic characteristics, food compositional analysis, and potential toxicity and allergenicity was undertaken by the concerned agencies [Bureau of Animal Industry (BAI), Bureau of Plant Industry- Plant Products Safety Services Division] and a Scientific Technical Review Panel (STRP) following the JDC No. 1 s2016's guidelines for the release of genetically modified organisms.
Bayer provided data on the identity of A5547-127, a detailed description of the transformation method, data and information on the gene insertion sites, copy number and levels of expression in the plant, the role of the inserted genes and regulatory sequences in donor organisms and full nucleotide sequences. The novel protein was identified, characterized and compared to the original bacterial protein, including an evaluation of their potential toxicity to livestock and non-target organisms. Relevant scientific publications were supplied.
The DA-Biosafety Committee evaluated the assessment of all agencies including the SEC experts and recommended for the approval of the said application. |
| Upload: |
|
| Date of authorization: |
01/02/2017 |
| 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): |
The safety assessment considers the safety of the bacterial Streptomyces donor organisms, S. hygroscopicus and S. viridochromogenes, from which the bar and the pat coding sequences were originally isolated. These Streptomyces species are widespread in nature. They are a common part of the living biosphere all over the world and very few Streptomyces species are associated with human, animal or plant pathogens. There are many species of Streptomyces similar to S. hygroscopicus and S. viridochromogenes and many of them are likely to contain pat or bar homologues. The same enzymatic specificity as observed with the PAT proteins has been identified in at least six other bacterial species from five genera of common soil bacteria and it is expected that at least some of these bacteria contain pat or bar homologues. None of these homologues have been reported as being toxic or allergenic in humans or animals in the review by Kutzner (1981).
The composition data from all trial sites were statistically analyzed with analysis of variance methods using a model with fixed factors for treatment (the transgenic and the non-transgenic seeds) and for site as well as their interaction term.
The proximate, fiber and amino acid analyses of the toasted meal samples confirm that the contents in the transgenic and non-transgenic soybean toasted meals are not different. The data derived from comparisons of proximate and fiber compounds in raw commodity soybean and processed soybean meal used as feed show variations within commercial references and literature ranges. Based on the statistical evaluation of the proximates, the seeds from soybean A5547-127 and the products derived from them were found to be nutritionally equivalent to their traditional non-transgenic counterpart.
Comparisons were also made with the non-modified comparator with respect to key nutrients. Relevant results are presented particularly on minerals and vitamins in seeds, tocopherol in food grade oil, amino acids in seeds and toasted meal, and fatty acids in seeds and food grade oil. The data derived from the comparisons of key nutrients in raw commodity soybean and processed soybean meal used as feed show variations within commercial and literature reference ranges.
The comparison establishes that seeds from glufosinate tolerant soybean event A5547-127 provide the same nutritional value as soybean seeds currently being consumed. There is no safety issue related to the consumption of A5547-127 soybean seed since the contents of all nutrients are comparable to the contents in seeds from other commercial soybean lines.
|
| Upload: |
|
| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
|
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
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: |
BASF Philippines, Inc. |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
01/03/2021 |
| 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): |
Permit Conditions:
The applicant has complied with the biosafety permit for direct use as food and feed, or for processing of Soybean A5547-127 (Number 17-002 FFP) through the information dissemination pertaining to the FFP approval, and the identification of appropriate measures in case of accidental release in the environment.
Other Scientific Papers:
The genetic stability of the insert, protein expression analysis, comparative analyses of compositional, agronomic and phenotypic characteristics, and toxicity and allergenicity analyses of the novel proteins indicate that a two stack (FG72 and A5547-127) and a three-stack event (MON 87708, MON 89788 and A5547-127) shows no new data that could pose food safety risk to humans [3][4].
Toxicological and allergenicity studies indicate that the novel protein does not share similarities to known toxins and allergens [3][4].
The crops’ genetic stability was not affected by the PAT protein and did not display any signs similar to a toxin or allergen protein when exposed to heat and gastrointestinal fluid [3].
There are no proven potential allergenicity of the PAT protein produced by Soybean A5547-127 according to the results based on the submitted final report of PAT protein Bioinformatics assessment of amino acid sequence identity [6].
Through the FASTA algorithm, COMPARE allergen database, and complete query sequence search, it is shown that the PAT protein is not significantly similar to any known allergenic protein and has no potential N-glycosylation sites [6].
|
| Upload: |
|
| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
|
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
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: |
Bayer Korea Ltd. |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
06/10/2011 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
|
| Summary of the safety assessment (food safety): |
Please see the link below(in Korean). |
| Upload: |
|
| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
|
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
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: |
Bayer |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
31/12/2014 |
| 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.): |
|
| Summary of the safety assessment (food safety): |
Soybean line A5547-127 (ACS-GM006-4) was developed to allow the use of glufosinate ammonium, the active ingredient in phosphinothricin herbicides as a weed control option in soybean crops. It was generated through the transfer of the pat gene to commercially available soybean line A5547. The pat gene encodes the protein phosphinothricin acetyltransferase (PAT), an enzyme that confers tolerance to glufosinate ammonium (phosphinothricin). The pat gene is derived from S. virochromogenes. Molecular analyses of soybean line A5547-127 indicate that the transferred pat gene is stably integrated into the plant genome at a single insertion site and is stably inherited from one generation to the next. Soybean line A5547-127 expresses a single new protein – PAT, which is non-toxic and non-allergenic to humans. Composition analyses showed that food from soybean line A5547-127 is equivalent in composition to that from other commercial soybean varieties. Food produced from soybean line A5547-127 is as safe as food produced from other soybean varieties. |
| Upload: |
|
| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
|
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
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)
| Name of product applicant: |
BASF (Thai) Limited |
| Summary of application: |
|
| Upload: |
|
| 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.): |
|
| 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 A5547-127 is substantially equivalent to its conventional counterpart in terms of morphology, nutrition, toxicity and allergenicity. |
| Upload: |
|
| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
|
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
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: |
Special case: please show below |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
05/11/2015 |
| 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 A5547-127 and products thereof for animal feed.
|
| Upload: |
|
| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
|
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): DG of Agricultural Research and Policies (TAGEM)
Contact person name: Ramazan BULBUL
Website:
Physical full address: Universiteler Mah. Dumlupınar Bulvarı, Eskişehir Yolu 10. Km
Çankaya/ANKARA/TURKEY
Phone number: +90 312 307 60 48
Fax number: +90 312 307 61 90
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.
Main objectives of the Biosafety Law are;
- to prevent risks that may arise from GMO’s and products which are produced by using of modern biotechnology by taking into account scientific and technological developments;
- to establish and implement biosafety system to ensure protection and sustainability of environment, biological diversity and health of human, animal and plant;
- to inspect, regulate and monitor the activities in the scope of the law.
The Law includes specific points regarding research, development, processing, releasing on the market, monitoring, using, import, export, handling, transportation, packaging, labelling, storage and similar operations in relation to GMO and GMOPs.
Veterinarian medicinal products and medicinal products for human use and also cosmetic products which are permitted or certified by the Ministry of Health are out of this Law’s scope.
According to Biosafety Law following actions connected with GMO and GMOPs are prohibited:
- Releasing GMO and GMOPs on the market without approval of Ministry of Agriculture and Forestry.
- Production of genetically modified plants and animals.
- Using GMO and GMOPs in baby food and baby formulae, follow-on baby food and follow-on formulae, infant and kid’s nutritional supplements
According to the Biosafety Law, which was enacted in 2010, the Biosafety Board, which was established within the scope of the Law, was responsible for evaluating the applications regarding GMO and its products.
However, the duties and powers of the Biosafety Board were assigned to the Ministry of Agriculture and Forestry with the Presidential Circular No. 2018/3 published in the Official Gazette on the date of August 2, 2018.
The task of evaluating the applications related to GMO and its products, performing the secretarial services of the Committees and other duties specified in the Biosafety Law and related regulations has been assigned to General Directorate of Agricultural Research and Policies (TAGEM) under the Ministry of Agriculture and Forestry pursuant to Ministerial Approval dated 05/12/2018.
Ministry of Agriculture and Forestry makes a “Decision” about applications on GMO and products via taking Scientific Committees’ risk assessment and socio-economic assessment into account.
For each application the Ministry of Agriculture and Forestry assigns a new committee and each committee makes different assessment for each application. It is important to note that in Turkey food and feed each have a different assessment application.
Members of scientific committees are selected from the List of Experts.
11 members are selected for each GMO application.
List of Experts has been made up by the evaluation of Ministry of Agriculture and Forestry from the applicants who applied via using the Biosafety Clearing-House Mechanism of Turkey. Applicants were faculty members and experts of Universities and TÜBİTAK (The Scientific and Technological Research Council of Turkey).
To date, 13 types of GM soybean and 23 types of GM maize were approved as feed for import.
Besides, by the use of aspergillus oryzae, developed through modern biotechnological methods, licences for industrial α-amylase, glucoamylase and hemicellulase enzyme production were granted.
Threshold of labeling of GMO products that are approved by Ministry of Agriculture and Forestry is 0.9%.
There are not any applications for using GMO and products as food.
After placing GMO and GMOPs on the market; the Ministry controls and inspects whether or not conditions designated by decision are met.
Activities of analysis are performed in laboratories designated by the Ministry.
In the case of any non-compliance detected with relation to the GMO Legislation (such as a failure to specify the contained GMO on the label, identification of an unapproved gene, etc.) legal action is taken.
Application evaluation process is like below:
- Evaluation of application by Ministry of Agriculture and Forestry 90 days
- Feedback to the applicant 15 days
- Ministry of Agriculture and Forestry’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
Ministry of Agriculture and Forestry’s final decision after taking reports and public opinions into
account
- Publishing the Positive Decision 30 days
- Reclamation period to Negative Decision 60 days
- Evaluation of reclamation by Ministry of Agriculture and Forestry 60 days
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Ministry of Agriculture and Forestry
General Directorate of Agricultural Research and Policies
Focal Point of the FAO GM Foods Platform
Ramazan BULBUL
Email: [email protected]
| Name of product applicant: |
AgrEvo |
| Summary of application: |
Soybean
Trait 1 Added Protein: Phosphinothricin acetyltransferase (PAT)
Source: Streptomyces viridochromogenes
Intended Effect: Tolerance to the herbicide glufosinate-ammonium
|
| Upload: |
|
| Date of authorization: |
15/05/1998 |
| 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.): |
|
| Summary of the safety assessment (food safety): |
Please consult the FDA website links below. |
| 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: |
FDA's webpage regarding this variety
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
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:
| Name of product applicant: |
Bayer Crop Science |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
19/09/2012 |
| 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.): |
BCH
|
| 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: |
GNBio
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Ministerio de Ganadería, Agricultura y Pesca
Contact person name: Alejandra Ferenczi
Website:
Physical full address: Constituyente 1476, Piso 2, Of. 212B. Montevideo, Uruguay
Phone number: +598 2 4104155 int 3
Fax number:
Country introduction: The Uruguayan National Biosafety System (SNB for its acronym in Spanish) includes safety assessments of food end feed, environmental risk assessment, risk management, and risk communication. The National Biosafety Cabinet (GNBio) is the competent authority on biosafety of GMOs. Integrated by: The Minister of Agriculture, MGAP (chair); Minister of Health (MSP); Minister of Economy (MEF); Minister of Environment (MVOTMA); Minister of Foreign Affairs (MRREE); and Minister of Industry (MIEM). This Cabinet 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 decisions of GNBio through risk analysis of biotechnological products. The Risk Management Commission (CGR) is composed by one delegate of each of the ministries represented within GNBio. The CGR advises GNBio on GMO biosecurity issues; elaborates reference terms for risk assessments; manages the risk communication participation process; is responsible for follow-up and monitoring of authorized events. The Risk Assessment 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 committee of technical experts from nine different national public and research institutions, which analyzes the risk assessment of new events and prepares a technical report. The technical analysis is coordinated by ERB organized in different ad hoc groups of experts. The Ad hoc experts groups are technical-scientific specialists in different areas of knowledge related to the analysis of GMO events like characterization and molecular identification of events, environmental and food safety aspects. Useful links
Relevant documents
Stacked events: GM vegetables from cross-pollinated species, such as corn, with stacked events are not considered as a new product. In the case of GM vegetables from self-pollinated species, such as soybean, are considered as a new product even if all single events stacked have already been approved. However, there is an abbreviated analysis procedure in cases where single events were already analyzed. Stacked events not yet analyzed must have the individual risk assessment report. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: GNBio office. E-mail: [email protected]; Adress: Constituyente 1476, piso 2, oficina 212B, Montevideo 11200, Uruguay.
| Name of product applicant: |
A5547-127 |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
22/08/2016 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
|
| Summary of the safety assessment (food safety): |
A5547-127 soybean is as safe as and substantially equivalent to its conventional counterpart. It shows no different allergenic or toxic potential compared to conventional soybean currently in the market. Compositional analyses of beans from A5547-127 soybean and current commercial soybean varieties were compared for compositional and nutritional parameters including moisture, crude fat, crude protein, crude fiber, ash, carbohydrates, mineral content, amino acid profile, and fatty acid composition. The data and findings show that A5547-127 soybean is compositionally and nutritionally equivalent to currently grown conventional commercial soybean varieties.
- The low potential for toxicity of the PAT protein present in A5547-127 soybean is demonstrated by examining the amino acid sequence homology, chemical characteristics of the protein and by acute oral toxicity testing in rats. The nucleotide sequence of the pat gene and the deduced amino acid sequence of the PAT protein were compared with sequences available for known toxins in the GenBank database and showed no significant homology with any known toxins or allergens.
- The PAT enzyme expressed in A5547-127 soybean does not possess characteristics typical of known protein allergens and is extremely unlikely to be allergenic. There were no regions of homology when the sequences of the introduced protein were compared to the amino acid sequences of known protein allergens. There was no evidence found of post-translational modifications such as acetylation, glycosylation or phosphorylation of the PAT protein. Unlike known protein allergens, the PAT protein was rapidly degraded by acid and/or enzymatic hydrolysis when exposed to simulated gastric fluids. In vitro digestibility studies, under simulated mammalian gastric conditions, demonstrated that the PAT enzyme was inactivated within one minute and was rapidly degraded. No adverse effects have been reported to be associated with this protein.
- To date A5547-127 soybean has been assessed for safety and approved for food and feed uses in over 16 countries worldwide. There are no adverse effects assumed with use of A5547-127 soybean and as a consequence there is no need for a case specific monitoring plan relating to import of herbicide tolerant A5547-127 soybean. The beans derived from A5547-127 soybean needs no specific or additional treatment and will be handled in the same way as any other conventional soybean commodity. |
| Upload: |
|
| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
|
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Ministry of Agriculture and Rural development
Contact person name: Nguyen Thi Thanh Thuy
Website:
Physical full address: 2, Ngoc Ha, Ba Dinh, Ha Noi, Viet Nam
Phone number: +84 08044643
Fax number: +83 4 38433637
Country introduction: The process for authorizing a GM food, feed is based on the Vietnam regulation on GM food and feed (Circular No. 02/2014/TT-BNNPTNT). An application for authorizing food, feed derived or made from a GM plant must be submitted to national authorities (Ministry of Agriculture and Rural Development-MARD). The national authority proceeds prior review the dossier/application and makes the application summary report available to the public. The authority then sends the application to the Food, Feed Safety Committee (FFSC) members for reviewing and risk assessment. FFSC is inter-ministerial committee established by the Minister of Agriculture and Rural Development in order to consult to MARD’s minister for issuance, revocation the Food, feed safety Certificate. Once FFSC performing the risk assessment (desktop reviewing), the public has 30 days to comment on MARD website for application. Within 180 days of receiving the appropriate application, FFSC complete the assessment and submit the final report to the national authority/MARD under Circular 02/2014/TT-BNNPTNT. Within 30 days receiving FFSC comment and conclusion, the national authority grants or refuses to issuing certificate.
Safety regulations have derived based upon the internationally established scientific guidelines and principles of Codex Alimentarius Commission, FAO, WHO and OECD.
FFSC does not separately assess food, feed from stacked event lines where food, feed from the GM parental events has already been approved separately; Mandate notification of stacked events by developers. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
|
|
