| Commodity: |
Corn / Maize |
| Traits: |
Glufosinate tolerance |
| Name of product applicant: |
Bayer CropScience GmbH |
| Summary of application: |
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| Upload: |
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| Date of authorization: |
24/04/2015 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
EU Register of authorised GMOs
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| Summary of the safety assessment (food safety): |
Please see the EU relevant links below.
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
Method for detection: Event-specific quantitative detection method for ACS-ZMØØ3-2 maize
Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003.
Reference material: AOCS 0306-H and AOCS 0306-C accessible via the American Oil Chemists Society.
Relevant links are provided below.
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| 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
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| Authorization expiration date (a blank field means there is no expiration date) |
26/04/2025 |
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: |
Aventis Pty Ltd |
| Summary of application: |
Aventis Pty. Ltd. have made an application to ANZFA to amend the Australian Food
Standards Code, to include food derived from corn which has been genetically modified to be tolerant to the herbicide glufosinate ammonium. The corn is marketed as Liberty Link® corn.
Tolerance in T25 corn to the herbicide glufosinate ammonium is achieved through the
expression of the pat gene, which produces the phosphinothricin acetyl transferase (PAT) enzyme that chemically modifies the herbicide, thus rendering it inactive.
Glufosinateammonium tolerant corn line T25 can be grown under application of this herbicide. Maize varieties are generally classified into flint, pop, dent and flour lines based on the hardness of the kernel. Flint varieties are preferred by dry millers for flour, grits and meal based products such as cereals and dent varieties are preferred by wet millers for starch and starch based products such as high fructose corn syrup. Corn oil may be produced from the germ of all varieties. Fermentation of cereal grains is also used for beverage and alcohol production.
A wide variety of food products are derived from the genetically modified corn including highly processed corn-based food ingredients such as high-fructose corn syrup, which is not currently manufactured in either Australia or New Zealand. Corn ingredients include flour, syrup, oil, starch, meal or whole kernels and cobs. Corn-based processed products include snap frozen vegetable packs, corn chips, corn oil, breads, flours, popcorn, pastries, crackers, meat substitutes, milk substitutes, breakfast cereals, and confectionary. There are also many industrial uses of corn products.
Food derived from glufosinate ammonium tolerant corn line T25 are most likely to be
imported as processed food products, containing whole, part or constituents of corn and as corn derivatives. |
| Upload: |
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| Date of authorization: |
09/05/2002 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
OECD BioTrack Product Database
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| Summary of the safety assessment (food safety): |
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| Upload: |
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Application A375 - Glufosinate ammonium tolerant corn T25
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| Authorization expiration date (a blank field means there is no expiration date) |
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E-mail:
Organization/agency name (Full name): Food 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 corn tolerant to glufosinate (phosphinotricin)
of ammonium herbicide, genetically modified, as well, as of
all the progenies coming from the transformation event T25
and its derivatives of the crossing of lines of nontransgenic
populations of corn with lines bearing the event
T25 |
| Upload: |
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| Date of authorization: |
17/05/2007 |
| 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
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| Summary of the safety assessment (food safety): |
Liberty Link Corn –
event T25. The plant received gene pat, which is responsible for the syntheses of enzyme phosphinotricin – N- acetyltransferase (PAT), that catalyzes the conversion
of L-phosphinotricin (glufosinate of ammonium) to non-toxic products, inactivating the active ingredient, conferring then, on the plant the characteristic of tolerance to the
herbicide. Gene pat is a modified version of the isolated gene of the soil natural bacteria, Streptomycin viridochromogenes, Tü 494 race, and was inserted into the
vegetable cells through direct incorporation of DNA in corn protoplasts electroporation), through vector plasmid pUC/Ac. The initiating sequences drawn aiming at identifying the event, that are represented as confidential information in the document entitled “Previous communications to the presentation of the biosafety report of event T25” shall be made available to the public. Due to the fact that it is a commercial release, there is no need of keeping confidentiality. Protein PAT was detected in low levels on the vegetable tissues analyzed, and is fast degraded in gastric and intestinal fluids, presenting great susceptibility to digestion and thermal desnaturation, being highly improbable that it may have any toxic or allergenic effect. Genetic modification introduced in event T25 did not result in important differences of chemical composition regarding nutrients, being within the normal variation scope among the conventional varieties. The sylvan species closer to corn is the teosinte found in Mexico and in some Central America places. Therefore, there is no sylvan species in Brazil with which corn can be crossed. The coexistence between conventional corn cultivations (improved or creoles) and transgenic cultivations of corns is possible from the agronomic point of view. Thus, the probability of fixation of allele containing the gene sequence that confers tolerance to glufosinate of ammonium on the population is much reduced on the absence of selection pressure. Corn is a plant that is incapable of surviving in natural conditions, when not technically assisted. Therefore, there is no possibility of corn being transformed into an invasive plant or weed. Genetically modified cultures behave like correspondent
conventional cultures, and up to now there is no registration of great alterations on the structures of microbial communities of soils. Additionally, gene pat already exists in the soil, once it comes from the soil natural bacteria, S. viridochromogenes. Glufosinate of ammonium is registered in Brazil, at the Ministry of Agriculture, Cattle Breeding and Supply (MAPA), at IBAMA, and its monograph is approved by the Ministry of Health, being commercialized in Brazil and in many other countries.
Thus, other norms should be observed when corn T25 is registered, such as Law 7.802, of July 11th, 1989 (Agro toxic Law), especially regarding the limits acceptable for herbicides residues to be established by the registration and inspection organs and entities. The restrictions to the use of the GMO in analysis, and its derivatives are
conditioned to the coexistence norms, and to the postcommercialization monitoring plan, to be eventually published by CTNBio. Thus, CTNBio considers that this activity is not potentially causing meaningful degradation of the environment, or aggravations to human and animal’s health.
Zea gender belongs to Gramineae family and has four kinds, being corn Zea mays ssp.mays L., the species that has the biggest economical importance. The number of chromosomes in Z. mays is 2n = 20, 21, 22, 24(5). It has been widely known that the center of origin of Zea mays ssp.mays includes Mexico and Central America (12). Corn is an allogamous and annual plant. Genes dissemination may occur via crossed
pollination with a sexually compatible plant or sylvan parental plants in the surroundings. Corn is pollinated by the wind, and the dissemination of the pollen is determined by the speed and direction of the winds. However, corn pollen feasibility, in extremely favorable conditions, is maximum 24 hours. The sylvan species closer to corn is teosinte, found in Mexico and in some places in Central America, where it can be crossed with corn cultivated in production fields. The cultivated corn can also be crossed with the most distant genre Tripsacum. However, this crossing occurs with great difficulty, and results on sterile-male progeny. Corn history is over eight thousand years old in the Americas, and nowadays it is the cultivated species that
reached the highest degree of domestication, and only survives in nature when it is cultivated by men . Of all the cultivated plants, it is probably the one that has the biggest genetic variability. Today, there are around 300 identified corn races, and within each race, thousands of cultivations. The maintenance of this genetic variability has been usually made through individualized storage, in germoplasm banks, with controlled conditions of humidity and temperature. There are many corn germoplasm
banks in Brazil and in the world. Embrapa has two germoplasm banks, one at Embrapa Genetic Resources and Biotechnology, in Brasília-DF, and another one at Embrapa Corn and Sorghum, in Sete Lagoas-MG. Corn is commercially cultivated in more than 100 countries, with a total production estimated in 705 million tons/year.
The biggest corn world producers are: The United States, China, Brazil, Mexico, France and India. Corn is used mainly for the production of animal food and processed
food, and recently, it has been used on the production of fuel alcohol. In the last harvest Brazil cultivated 12million hectares of corn. While the average productivity in
the USA is 9.0, and in Argentina it is 7.0 tons/ha, the average productivity in Brazil was 3.5 tons/ha. Such low productivity of corn culture in Brazil is not because of
lack of technology, but for the fact that a meaningful part of Brazilian agriculturists who plant corn do not use improved seeds, or do not have access to modern
technologies of cultivation. Agriculturists of the Brazilian Center-West that use modern technology and tropical simple hybrid seeds manage to produce an average
similar to the one obtained by its peers in the USA, that is, 9.0 tons/ha.
Scientific work of corn improvement (“hybrid corn era”) started in Brazil around 1930, at the Agronomic Institute of Campinas – IAC, and at the Federal University of Viçosa
– UFV. Today, we have in Brazil many national and foreign companies that at the 2006/2007 harvest made available around 275 different kinds of corn cultivation, improved and adapted to the tropical conditions of the country. This is the result of more than 50 years of genetically improved tropical corn that started with the so-called races of Creole corn. It is also important to highlight that, in this universe of 275 commercial genotypes, we have creoles varieties (corn improved by small agriculturists, whose seeds may be reused), and also state of the art simple hybrids (for high technology plantation, with production potential above 12 tons/ha). Today, Brazil develops the biggest, the most efficient, and the most traditional program of tropical corn improvement in the world. The commercial event Liberty Link Corn was obtained by the direct transformation of protoplasts through electroporation process. The tolerance to glufosinate of ammonium herbicide was obtained through the introduction of the gene that expresses the protein PAT (Phosphinotricin Nacetyltransferase) isolated from Streptomycin viridochromogenes that after catalyzing the acetilation of L-phosphinotricin (glufosinate of ammonium), promotes the inactivation of the active component. As a consequence, plants of the referred event of transformation are resistant to the herbicide, allowing its use in the control
of invasive plants. In Brazil, many planned releases of corn T25 in the environment, in experimental character, were conducted after approval by CTNBio in regions that represent the corn culture, including the states of São Paulo, Minas Gerais,
Mato Grosso do Sul, Paraná, Goiás, Rio Grande do Sul and Bahia.
III. GMO description and expressed proteins
The commercial event Liberty Link was obtained through the direct transformation of protoplasts of corn lineage He/89 through the use of polyethylene glycol (PEG) with the plasmodium pUC/Ac as a whole containing genic elements of interest. The transformed protoplasm were cultivated under selection conditions in the presence of glufosinate of ammonium herbicide, also known as L-Phosphinotricin (PPT – Phosphinotricin) until they originate cellular agglomerate that were later regenerated to normal plants according to protocol established by Mórocz and collaborators (14).
The main elements that compose the cassette of expression containing pat gene, as well as the main elements present on the plasmid pUC/Ac are:
a. plasmid pUC18: plasmid of Escherichia coli with high number of copies, used for cloning fragments of DNA;
b. ampR – gene that confers resistance to ampicillin obtained from E. coli, and that codified b – Lactamase (bla), being express4ed only in bacteria, once it is
under control of prokaryotic promoter;
c. Ori-pUC – replication origin (ColE1) of plasmid pUC18;
d. P-35S – promoter of transcribed 35S of virus of cauliflower mosaic;
e. pat – codifying sequence of pat gene of S. viridochromogenes modified with codons preferential for plants, once the original sequence presents high content of G:C, atypical for plants;
f. T-35S – terminator region not translated into proteins, obtained from the transcribed 35S of virus of cauliflower mosaic.
Molecular studies of event T25 presented in the process allow to visualize how a copy of the insert was introduced into the genome of LL corn. Bla gene that confers
resistance to ampicillin is present, but it was fragmented, and its portion of nucleotide 6 to 195 was eliminated from the event. The studies also show that a sequence similar to the promoter 35s is at the end of the insert flanking the other portion of bla gene present in the insert, corresponding to nucleotides 196 to 861. The replication
region (ColE1) of the plasmid pUC18 is also present in the insert, as well as the cassette of expression with the codifying sequence of pat gene with the promoters and
terminators regions of transcribed 35S in the correct conformation for the expression of pat gene, that was introduced into the corn genome in a sole copy through
direct incorporation by the electroporation method. In the event T25 characterization, regions of genomic DNA of corn, which flank the place of the insert were also
sequenced. That allowed identifying that the region where it was inserted presented high similarity with one of the gene alleles of alcoholic desidrogenase of corn. Such
allele was probably inactivated, but as this gene presents high number of copies on the genome of the species, the insertion of the elements described above have not
apparently harmed the development and the agronomic characteristics of the plants. No molecular data was presented confirming or not the inactivation of the
alcohol-desidrogenase (gene bank access No. AF1223535). However, the event T25 was tested on the field, and in contention in the United States and in Canada, and the
comparison between the event T25, and not genetically modified hybrid corn plants did not identify alterations on agronomic characteristics that are out of the normal range of variability for characteristics such as productivity, plants height, cycle, susceptibility to diseases and plagues, profitability components, and others. On planned releases in the environment conducted in Brazil, no alterations were observed in the agronomic characteristics of corn T25, which would be different from the patterns found in hybrids, and in not genetically modified corn lineages. Thus, it is possible to assume that the insertion of the fragment described above in the corn genome did not alter its normal fenotypical characteristics.
The sequencing of the genomic regions of corn that flank the insert are also important, for they allow identifying this event as unique. The flanks were sequenced on region 5’, 151pb, and on the region 3’, 121pb from the insert. The starting sequences drawn to identify the event, and that are presented as confidential information on the document “Previous Communications to the submission of the biosafety report of event T25” are available to the public. The sequencing of the entire insert present in the event T25 also allowed to identify, on the junction between the
major fragment of bla gene, and the region with elements similar to promoter 35S, two open reading frames (ORF – Open Reading Frame): ORF-1, codifying 253 amino acids and ORF-2, codifying 109 amino acids. The petitioner does not describe if these ORF codify some protein of known function. No data confirming or not the expression of these hypothetical proteins in event T25 have not been presented either. On both ORF, the initiation codon is found inside the fragment similar to promoter 35S, and not inside the fragment of bla gene. This situation, as well as the incomplete presence of the entire sequence of the promoter 35S in this region, would probably(16) make impractical the expression of ORF 1 and 2.
The construction used on the transformation puts bla gene under control of a prokaryotic promoter, making this gene to be expressed only in bacteria(10). Even being the bla gene incomplete in event T25, tests were conducted to identify the presence of enzyme b-lactamase and of transcribed ones. Enzymatic or transcribed activity of bla gene was not detected in none of the vegetative and
reproductive parts of Liberty Link corn. The analysis of PAT protein expression was made on leaves, roots, stems, grains and pollen through TLC, HPLC and
ELISA. It was not possible to detect the presence of protein activity in pollen grains. In seeds, roots, leaves and stems the detected activity was of 0.68, 5.36, 41.32
and 50.95 mU/mg, respectively. Considering that the promoter used is constructive CaMV 35S, one could expect PAT expression in every tissue on similar levels. However,
it is already known that promoter 35S, depending on the tissue and place of insertion in the genetically modified plant genome, may present variations in its gene activation
capacity.
The number of inserts was estimated through Southern Blots made with five enzymes of restriction, and confirmed as a copy through tests of segregation in the progeny of
crossings made between hemizygote plants and nongenetically modified lineages. These results indicated that pat gene is transmitted in a stable way between generations and behaves as a normal and dominant gene.
IV. Aspects related to Human and Animal’s Health The evaluation of food safety derived from genetically modified raw material is based on risk analysis, scientific
methodology that encompass evaluation, management, and risk communication phases. On the risk evaluation phase one looks for the qualitative and quantitative characterization of potential adverse effects, having as base the concept of substantial equivalence, for the identification of eventual differences between the new food and its conventional correspondent.
To evaluate safety of genetically modified food raw material, or its equivalence to conventional food, it is recommended that four main elements are analyzed, more
notably: (1) parental variety, that is, the plant that originated the new genetically modified raw material; (2) the transformation process, including the characterization
of the construction used, and of the resulting event; (3) the gene product inserted and the potential of toxicity and allergenicity, and finally; (4) the composition of the new variety deriving from the genetic transformation. The group of data of these analysis should allow for the identification and characterization of the potential
different effects associated to the consume of the new raw material, subsidizing the management and risk communication phases.
According to the petitioner, event T25 derives from the transformation of cells of lineage He/89 of common corn Zea mays, a species deeply characterized, and about which there is solid safety background for human and animal consume.
Information about identity, origin and chemical composition are reported, and a copy of the publication was attached to the process, which provides abundant data regarding its composition, highlighting the variations naturally observed
in the presence of nutrients.
The analysis of chemical composition of the variety obtained through gene manipulation, mainly of the levels of its nutrients and eventual toxic compositions naturally present, aims at guaranteeing that this new variety is as nutritive and safe as its conventional equivalent. Thus, it serves to confirm that intentional effects of
modification do not compromise its safety, or results in unintended effects. The introduction of cassette of expression containing pat gene, as well as other gene
elements described before, do not alter the substantial equivalence of Liberty Link corn in relation to the quality and quantity of metabolite normally found in corn. The data presented by the petitioner are related to the centesimal composition, to the profiles of amino acids, fatty acids, mineral and vitamins, besides the content of phitate, both for the genetically modified variety, with and without the use of glufosinate, and for the conventional variety, cultivated under the same conditions and on the same region during the same period. At the beginning, results from analysis conducted with plants cultivated abroad in two regions were presented. Late on, due to questionings made by CTNBio’s members, data regarding plants cultivated in the country in different environments were presented, in the state of Goiás and Paraná. These compositions analysis were made in the country at the Institute Adolfo Lutz, of São Paulo. In general, for all the parameters analyzed, there was a
meaningful difference between the genetically modified variety and the conventional one, or the differences noted were within the variability normally observed among
conventional corn varieties. Anyway, the small differences found in relation to event T25 do not affect the nutritional value, or safety, for they were similar to the ones usually found in other varieties, or under different conditions of cultivation. In this regard, it is important to highlight that there were differences among the results
obtained for the cultivations executed in Goiás and in Paraná, even for the conventional variety, without, thou, resulting in meaningful difference of the latter for the genetically modified variety. Thus, it is clear that the environmental conditions were more determining for the differences in the chemical composition, than the presence of pat gene in the genome of the transformation event T25.
In relation to the levels of residues of glufosinate of ammonium left in the plant, due to its use during the cultivation of transgenic variety, studies executed in
Brazil showed that there were no differences between those levels found in the parental variety when compared to the transgenic variety (event T25), when the herbicide is applied in accordance with the patterns of the Brazilian legislation for the evaluation of the maximum limits of residues.
PAT protein is degraded by the gastric juice of animals and by similar artificial gastric juice of human beings, losing its physical-chemical characteristics after oral
exposition. Thus, the protein is not expected to be fully absorbed, and, therefore, it is highly improbable that the protein may reduce different or toxic effects. Besides, PAT
protein activity in the different parts of corn is low (around mU/mg of protein).
References about acute toxicity were described in documents of the Environmental Protection Agency of the United States and of DG Health and Consumer Protection of the European Commission indicating lack of toxicity. “The oral acute
toxicity test of PAT protein produced in bacteria showed lack of effects in a dose of 2,500 mg/kg”(19). “The enzyme phosphinotricin acetyltransferase (PAT) should not present biosafety problems. The quantitative level of PAT in grains is very low. Its enzymatic function is specific for a substrate that is naturally absent in human beings, called phosphinotricin. Besides, it is degraded and inactivated in human artificial gastric fluid containing pepsin in pH 1.0- 1.2. Therefore, it is improbable that it maintains any enzymatic activity in vivo. What’s more, no homology between PAT protein and toxins known was found. Native PAT protein (51% of purity) was evaluated for acute toxicity in rats, and no effect in 5.0 g doses per kg of corporal
weight was reported” (4). There are no reports saying that PAT protein has allergenic
activity. Analysis of sequences of PAT protein show that it does not present places capable of glicolisation what could theoretically, confer allergenicity to protein. However, a possible source of PAT protein allergenicity would be the expression of protein in pollen, what does not seem to occur. Gene pat sequence and PAT protein were compared to data banks, and it was observed that they do not present
meaningful homology with other sequences of nucleotides and proteins, except for others genes of resistance to phosphinotricin including gene pat of S. viridochromogenes and bar gene of S. hygroscopicus.
V. Environmental Aspects
Corn is a monoic plant: a sole individual contains male and female flowers located separately. Corn plants are plants of crossed fecundation and widely pollinated with the wind help, insects, gravity and others. The introduction of gene
elements previously described did not alter the reproductive characteristics of the plant. Therefore, the probability of crossed fecundation between plants of the
event T25 and other corn plants is the same as the one that occurs between hybrids and corn lineages not genetically modified.
Corn is the species that reached the highest level of domestication among cultivated plants, losing its characteristics of survival in nature as, for example,
degrana elimination. Thus, corn is a plant that is incapable of surviving in natural conditions, when not technically assisted. Therefore, there is no possibility of
corn being transformed into an invasive plant or weed.
Gene flow in corn may occur through pollen transfer and seeds dispersion. Seeds dispersion is easily controlled, once the domestication of corn eliminated the ancient
mechanisms of seeds dispersion, and, therefore, the pollen movement is the only effective escape mean of genes of corn plants.
Studies about corn pollen dispersion have been conducted, and some of them show that corn pollen may travel long distances. However, most pollen that is released is
deposited near the culture, with very low translocation rate outside the source culture. The predominant pollination agent for corn is the wind and the distance that viable pollen may travel depends on wind patterns, humidity and temperature. Luna et al. evaluate the distance of isolation and control of pollen and demonstrate that crossed pollination occurs in a maximum distance of 200m and no crossed pollination happened in the same distances or over 300 meters in relation to pollen sources,
in non detasseling condition. The results indicate that pollen viability is kept for 2h, and that crossed pollination was not observed in 300 meters distances from
the pollen source.
Under low to moderate winds, it was estimated that comparing concentrations to 1 of source culture, approximately 2% of pollen are annotated at 60m, 1.1% at 200m and 0.75-0.5% at 500m of distance. At 10m from a field, in average, the number of pollen grains per area unit is ten times smaller than the one observed at 1m from the border. Therefore, if the established distances of separation developed for corn seed production are observed, it is expected that the pollen transfer to the adjacent varieties are minimized, and it shall not have any genetic material with tolerance to herbicide. Even in case of having a gene escape, the probability of allele fixation
containing the gene sequence that confers tolerance to glufosinate of ammonium in the population is much reduced in the absence of selection pressure.
The secondary ecological impacts, that refer to effect in the environment, especially in the ecosystem of the soil, are very discussed nowadays due to the complexity of the
soil. The organisms of the soil are usually very exposed to the contact with genetically modified plants, both with direct contact, and through the fall of leaves, reticular
exudates or even decomposition of roots. Through the reports in literature, genetically modified cultures behave similarly to conventional correspondent cultures, and
meaningful alterations have not been detected until now on the structures of microbial communities of the soils.
Studies of plants intact genes transfer to microorganisms show extremely low possibilities of transfer, suggesting that the probability of occurrence of this event is, in
practice, extremely low. There is no evidence that plants genes have even been transferred to bacteria in natural conditions. Moreover, gene pat already exists in the soil, once it comes from a natural soil bacteria, S. viridochromogenes. Glufosinate of ammonium is a non systemic and non selective herbicide used, mainly, in the control of post-emergency invasive plants of wide leaves, and of thin ones. Such herbicide is registered in Brazil, at the Ministry of Agriculture, Cattle Breeding, and Supply (MAPA), at the Brazilian Institute of Environment and Renewable Natural
Resources (IBAMA), and with monograph approved by the Ministry of Health, being commercialized in Brazil and in other countries. Its wide use in the world is due to the
fact that it is biodegradable, presents low residual activity, low toxicity to men, animals, and other organism of the food chain. It is considered persistent and movable
in the soil, and in sandy soils up to 80% may be lixiviate. Depending on handling conditions, edafoclimatic conditions, microbial activity, and other factors, glufosinate of
ammonium has half-life in the soil that varies from 12 to 70 days. However, residues have been found in the soil after 100 days. Therefore, if it is used outside its recommendations, glufosinate of ammonium herbicide has potential for contaminating water courses and groundwater as any other herbicide used in genetically modified
cultures or not. However, it is highlighted that other norms should be observed when T25 corn is registered, such as Law 7.802, of July 11th, 1989 (Agro Toxic Law)
especially regarding the acceptable limits for residues of herbicides to be established by the registration and inspection organs and entities mentioned above.
VI. Restriction to the use of GMO and its derivatives:
Technical opinions regarding the agronomic performance came to the conclusion that there is equivalence between transgenic and conventional plants. Thus, information
indicate that transgenic plants do not fundamentally differ from non transformed corn genotypes, except for the tolerance to glufosinate of ammonium herbicide.
Additionally, there is no evidence of different reactions to the use of Liberty Link corn. So, there is no restriction to the use of this corn, or of its derivatives,
be it for human or for animal food. The vertical genic flow for local varieties (called creoles corns) of open pollination is possible and presents the same risk caused by commercial genotypes available in the market (80% of planted conventional corn in Brazil comes from commercial seeds that went through a process of genetic improvement). The coexistence between conventional corns cultivation (improved or creoles) and transgenic cultivations of corns is possible from the agronomic point
of view (3,13). Therefore, CTNBio will eventually publish norms about coexistence of genetically modified corn with non modified varieties.
VII. Considerations about the particularities of different
regions of the country (subsidies to inspection organs): Small variations of centesimal composition, not meaningful ones, were found between the corn planted in the South
region (Paraná), and the one planted in the Center West Region (Goiás) that were imputed, not to the presence of the transformation event, but to environment conditions. Therefore, there are no restrictions to the use of this corn, at least in relation to the South, Southeast and Center West of the country. The registration and inspection organs, in the ambit of their competences, will establish acceptable limits of
residues to herbicide glufosinate of ammonium used in plantations cultivated with corn T25.
According to what is established on art. 1 of Law 11.460, of March 21st, 2007, “it is vetoed the research and cultivation of genetically modified organisms in indigenous
lands and areas of conservation units”. CTNBio will eventually publish norms about the coexistence of genetically modified corn with non modified varieties.
VII. Conclusion
Considering that event T25 derives from the lineage He/89 of common corn (Zea mays), species with solid safety background for human and animal consume, and that the introduced gene, pat, does not codified proteins known as toxic or allergenic, and results on the enzyme Lphosphinotricin- N-acetyltransferase, with high specificity
for the herbicide glufosinate of ammonium.
Considering that the gene construction used on the transformation resulted on the instable insertion of a copy of pat gene, and regulating regions of the mosaic virus of
cauliflower on the genome of corn, besides a non-functional incomplete sequence of the gene of resistance to ampicillin, resulting only on PAT expression, without
apparent harm to the plant or to the environment. Considering also that:
1. Corn is the species that reached the highest degree of domestication among plants cultivated, being able to survive in nature without human intervention. 2. The sylvan species closer to corn is teosinte, found in Mexico and in some places in Central America, where it can be crossed with corn cultivated in production fields.
Therefore, there are no sylvan species in Brazil with which corn can be crossed.
3. Protein PAT has rapid degradation in gastric and intestinal fluids (7,20).
4. Recombinant enzyme PAT was detected in low levels of analyzed vegetable tissues, and presented great susceptibility to digestion and thermal denaturation by the
processing, being highly improbable that it may have any toxic or allergenic effect
5. There are many proteins similar to PAT in nature without any evidence of adverse effect to men, animals, or plants have been described, and that its subtract is highly
specific, not having any sequence of amino acids with homology to toxins or allergens.
6. Genetic modification introduced in event T25 did not result in important differences of chemical composition regarding nutrients, being within the normal variation
scope among the conventional varieties.
7. Microorganisms S. hygroscopicus and S. viridochromogenes are saprophyte bacteria of the soil, and there are many species of Streptomycin genre similar to S. hygroscopicus and S. viridochromogenes, and among them, many containing
pat and bar genes.
8. DNA molecule is a natural food component, not presenting any evidence that such molecule may have adverse molecule effect to men when ingested in food in acceptable quantities (no direct toxic effect).
9. There is no evidence that intact genes of plants may be transferred and functionally integrated in human genome, or of other mammals exposed to this DNA or foods manufactured with these elements
10. Plants tolerant to glufosinate of ammonium containing PAT protein have been cultivated in the United States and in Canada for approximately a decade without any
registration of adverse effect to human and animal food.
Besides, many regulating agencies of varied countries have approved these plants for these plants for human and animal use including Australia, Japan and European Union.
11. The petitioner answered to all questionings postulatedon the Normative Instruction No. 20 at CTNBio. 12. None of the questions indicate that this corn may
present adverse effects on human and animal food. 13. After ten years of use in different countries, no problem was detected for human, animal’s health, or to the
environment that may be attributed to transgenic corns. It is necessary to emphasize that the lack of negative effects resulting of corn transgenic plants does not mean that they may not happen. Zero risk and absolute safety does not exist in biologic world, although an accumulation of trustworthy scientific information already exists, and a safe background of ten years use allows us to state that corn T25 is as safe as conventional versions. Thus, thepetitioner is conditioned to conduct monitoring of postcommercial release on the terms to be eventually established by CTNBio.
14. The coexistence among cultivations of conventional corns (improved or creoles) and transgenic cultivations is possible from the agronomic point of view.
15. The probability of allele fixation, containing the gene sequence that confers tolerance to glufosinate of ammonium on the population is much reduced in the absence of selection pressure.
16. There is no need of maintenance of confidentiality in relation to the commercial release.
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
Traditional Molecular Methods. |
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
National Biosafety Comission
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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: |
Corn transformants T14 and T25 were developed through genetic modification to be tolerant to glufosinate ammonium, which is the active ingredient of the herbicide Liberty®. The modification permits farmers to use the broad-spectrum herbicide for weed control in the cultivation of corn without damaging the crop.
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| Date of authorization: |
03/04/1997 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
BioTrack Product Database
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| Summary of the safety assessment (food safety): |
Please see decision document weblinks |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Novel Foods Decision
Novel Feeds Decision
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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: |
Bayer Cropscience |
| Summary of application: |
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| Date of authorization: |
06/04/2004 |
| 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
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| Summary of the safety assessment (food safety): |
Please see decision document uploaded |
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
Chinese Agriculture Department Announcement No. 869-14-2007: Detection of Genetically Modified Plants and Derived Products Qualitative PCR Method for Herbicide-Tolerant Maize T25 and Its Derivates |
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Authority concern of GMO
Ministry of Agriculture of China
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| Authorization expiration date (a blank field means there is no expiration date) |
6/4/2007 |
E-mail:
Organization/agency name (Full name): Development Center for Science and Technology, Min
Contact person name: Fu Zhongwen
Website:
Physical full address: Room 717, Nongfeng Building, No.96 Dong San Huan Nan Lu, Chaoyang District, Beijing, 100122, P. R. China
Phone number: +86-10-59199389
Fax number: +86-10-59199391
Country introduction: Regulations on Safety of Agricultural Genetically Modified Organisms (hereafter referred to as the Regulations)was promulgated by Decree No. 304 of the State Council of the People’s Republic of China on May 23, 2001. Implementation Regulations on Safety Assessment of Agricultural Genetically Modified Organisms, Implementation Regulations on the Safety of Import of Agricultural Genetically Modified Organisms and Implementation Regulations on Labeling of Agricultural Genetically Modified Organisms are formulated by Ministry of Agriculture on January 5, 2002 in accordance with the Regulations. The State Council establishes a system of joint ministry conference for the safety administration of agricultural GMOs. The joint ministry conference for the safety administration of agricultural GMOs shall be composed of officials from relevant departments of agriculture, science and technology, environment protection, public health, foreign trade and economic cooperation, inspection and quarantine, and be responsible for the decision-making and coordination of major issues with respect to the safety administration of agricultural GMOs. According to Article 9 of the Regulations, a national biosafety committee (NBC) shall be established and in charge of safety assessment of agricultural GMOs. The NBC shall be composed of experts who are engaged in biological research, production, processing, inspection and quarantine with respect to agricultural GMOs, as well as experts in the fields of public health and environmental protection. The office term of the NBC shall be three years. Ministry of Agriculture is responsible for the nationwide supervision and administration of the safety of agricultural GMOs. The Ministry of Agriculture sets up an office for biosafety administration of agricultural GMOs(OBA), which will be in charge of the administration of the safety assessment of agricultural GMOs. OBA is Affiliated to the Department of Science, Technology and Education. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: office for biosafety administration of agricultural GMOs(OBA), the Department of Science, Technology and Education,MOA, P. R. China Tel:+86-10-59193059, Fax:+86-10-59193072, E-mail: [email protected]
| Name of product applicant: |
Bayern Crop Science |
| Summary of application: |
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| Date of authorization: |
26/01/2012 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
Based on the risk assessment, it can be concluded that the event shows the same risks as its conventional counterpart. Therefore the National Technical Biosafety Committee for GMO use exclusively in Health and human consumption (CTNSalud) recommends its authorization. |
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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 South Africa on behalf of BASF Agricultural Solutions Seed US LLC |
| Summary of application: |
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| Date of authorization: |
30/06/2022 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
Risk Assessment
Decision
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| Summary of the safety assessment (food safety): |
Findings showed that safety and nutritional assessments of the maize event T25 approved in Argentina, Canada, European Union, South Africa, Republic of Korea, and USA confirm the event is as safe as its conventional counterpart. The TAC also noted that there are other countries where similar approvals had been granted on the maize event T25 including Australia, Japan, Mexico, New Zealand, Brazil, Viet Nam, Philippines, Nigeria, and Colombia. These countries have also approved the maize event T25 for various purposes, including for cultivation, and for direct use as food, feed or for processing (FFP).
The TAC concludes that, based on the assessment of the maize event T25 approved for direct use as food, feed or for processing in the country of origin (South Africa) and 14 other countries, there are no biosafety concerns with the event intended to be imported for direct use as food, feed and for processing in Ghana. |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Risk Assessment
Decision
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JUNE 29, 2025 |
E-mail:
Organization/agency name (Full name): Ministry of Environment Science Technology and Inn
Contact person name: Eric Amaning Okoree
Website:
Physical full address: Ministries Accra
Phone number: 00233208163038
Fax number: 00233302688913/68866
Country introduction: The Ministry of Environment, Science, Technology and Innovation, is responsible for the regulation of all activities related to the management of the environment for the purpose of attaining sustainable development in line with the Millenium development goals. Consequently, the Ministry is responsible for the implementation of the Biosafety Law (Act 831) which came into force on 31 December 2011.
The Ministry imlemented the National Biosafety Authority in July 2015 to be responsible for all matters on rDNA-derived foods. The NBA receives, reviews and decides on all applications of this nature. Based on the type of application, the Act 831 constituted the Technical Advisory Committee to review the application and submit report to the Board of the NBA to make decision. Ghana has not yet carried out any rDNA-derived food safety assessment however, the NBA has approved confined field trials of rDNA-derived cotton, sweet potato, rice and cowpea. Currently, the National Biosafety Clearing House is undergoing maintenance, however the Ghana page on the Global Biosafety Clearing House has additional information that may be accessed through the following address: bch.cbd.int/about/countryprofile.shtml?country=gh Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: National Biosafety Authority, working with the Food and Drugs Authority as the Regulatory Agency for Food safety.
| Name of product applicant: |
PT. BASF Indonesia |
| Summary of application: |
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| Date of authorization: |
12/08/2020 |
| 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 cliring house
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| Summary of the safety assessment (food safety): |
Indonesian National Agency of Drug and Food Control certified food safety for GM Maize event T25 tolerant to Glufosinate |
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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: |
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| Date of authorization: |
25/10/2016 |
| 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.): |
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| Summary of the safety assessment (food safety): |
Competent National Authority: Ministry of Agriculture-Jehad, Agricultural Research, Education and Extension Organization (AREEO). Risk Assessment file is uploaded.
https://bch.cbd.int/en/database/RA/BCH-RA-IR-114165/2 |
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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:
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Agricultural Jihad Ministry
Tehran, Tehran
Iran (Islamic Republic of)
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Ministry of Health and Medical Education- Food & Drug Administration
Food and Drug Administration, Fakhrerazi St., Enghelab Ave.
Tehran
Iran (Islamic Republic of), 1314715311
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| Name of product applicant: |
BASF (Malaysia) Sdn. Bhd. |
| Summary of application: |
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| Date of authorization: |
08/01/2013 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
Department of Biosafety Malaysia
CBD Biosafety Clearing House
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| Summary of the safety assessment (food safety): |
Please refer to uploaded document. |
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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E-mail:
Organization/agency name (Full name): Department of 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 de México, S.A. de C.V. |
| Summary of application: |
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| Date of authorization: |
27/04/2007 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
UI OECD: ACS-ZMØØ3-2
During the risk assessment of this GMO based on existing knowledge to date, no toxic or allergic effects neither substantial nutritional changes are observed. The event is as safe as its conventional counterpart.
For more detail please find attached the risk assessment summary in this page.
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E-mail:
Organization/agency name (Full name): CIBIOGEM
Contact person name: Dra. Consuelo López López
Website:
Physical full address: San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number: +52 (55) 53227700
Fax number:
Country introduction: México ha buscado garantizar la inocuidad de los productos biotecnológicos para el uso y consumo de su población.
Desde 1984 el artículo 282 bis 1 de la Ley General de Salud, contempló que la Secretaría de Salud debería regular aquellos productos biotecnológicos, o sus derivados, destinados al uso o consumo humano.
En un inicio, con fundamento en este artículo, la Secretaria de Salud evaluó la inocuidad alimentaria de productos biotecnológicos, para su comercialización con fines de uso o consumo humano. A partir de 2005, con la entrada en vigor de la Ley de Bioseguridad de Organismos Genéticamente Modificados (LBOGM), se realizó la adecuación de la regulación para dar lugar a la Autorización que es el acto administrativo mediante el cual la Secretaría de Salud, a través de la Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), autoriza Organismos Genéticamente Modificados (OGMs), a efecto de que se pueda realizar su comercialización, así como su utilización con finalidades de Salud Pública o de Biorremediación.
Las facultades que corresponden a la Secretaría de Salud se estipulan en el artículo 16 de la LBOGM y lo relativo a la Autorizaciones se describe en los artículos 91 al 98 de dicha Ley.
Quienes pretendan obtener una Autorización para Comercialización e Importación de OGMs deben presentar ante COFEPRIS, una solicitud por escrito acompañada de la información a que se refiere los artículos 23 al 32 del Reglamento de la Ley de Bioseguridad de OGMs.
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf
Courtesy translation
Mexico has sought to guarantee the safety of biotechnological products the use and consumption of its population. Since 1984, article 282 bis 1 from the General Law of Health, considered that the Secretary of Health should regulate those biotechnological products, or their derivatives, intended for food and feed use. Initially, the Secretary of Health evaluated the food safety of biotechnological products, based on this article, for commercialization with purposes of food, feed and processing. Subsequently in 2005, with the entry into force of the Law on Biosafety of Genetically Modified Organisms (LBOGM), the regulation was adapted to give rise to the Authorization, which is the administrative act through which the Secretary of Health, by means of the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), authorizes Genetically Modified Organisms (GMOs), to their commercialization, as well as their use for purposes of public health or bioremediation.
The faculties that correspond to the Secretary of Health are stipulated in Article 16 of the LBOGM and what is related to the Authorizations is described in Articles 91 to 98 of this Law. Those who seek to obtain an Authorization for GMOs merchandising and importation, must present to COFEPRIS, a written request accompanied by the information referred into articles 23 to 32 of the Regulation of the Law on Biosafety of Genetically Modified Organisms.
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
Aventis Pty Ltd |
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| Date of authorization: |
20/12/2002 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
OECD BioTrack Product Database
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| Summary of the safety assessment (food safety): |
Food from glufosinate ammonium tolerant corn line T25 corn has been evaluated according to the safety assessment guidelines prepared by ANZFA. The assessment considered the following issues: i) the nature of the genetic modification; ii) general safety issues such as novel protein expression and the potential for transfer of antibiotic resistance genes to microorganisms in the human digestive tract; iii) toxicological issues; and iv) nutritional issues.
On the basis of the data submitted in the present application, it is concluded that food derived from glufosinate ammonium tolerant corn line T25 is as safe and wholesome as food from other commercially available corn varieties. A detailed food safety report on these foods has been prepared. |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Application A375 - Glufosinate ammonium tolerant corn T25
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E-mail:
Organization/agency name (Full name): Ministry for Primary Industries
Contact person name: john vandenbeuken
Website:
Physical full address: Pastoral House, 25 The Terrace, Wellington, 6012
Phone number: 0298942581
Fax number:
Country introduction: New Zealand and Australia share a joint food regulation system for the composition of labelling of most foods. Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of the joint food standards in Australia and New Zealand. The main office (approximately 120 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 15 staff) is located in Wellington on the North Island. Useful links
Relevant documents
Stacked events: FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5) Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
BASF PARAGUAYA S.A. |
| Summary of application: |
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| Date of authorization: |
04/08/2021 |
| 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.): |
ACS-ZMØØ3-2
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| Summary of the safety assessment (food safety): |
Simplified approval procedure: Through Ministry of Agriculture and Livestock Resolutions 1030 and 1071 there was stated a differentiated treatment for the commercial release of novel GE crops and for GE crops that have been approved in third countries, whose scientific, technical and safety characteristics are well-founded. Paraguayan Ministry of Agriculture’s Resolutions authorize taking into consideration the decision documents from third countries with regard to both human and animal food safety in the cases where these evaluations have been based on Codex Alimentarius, such as the Guidelines for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants and carried out in countries with time-tested regulatory systems and transparent procedures.
Concerning environmental safety, assessments are accepted for GE crops that besides having been authorized for commercial planting in countries with sound regulatory systems, include in the decision documents considerations as follows: that the GE crop under review has been studied under different environmental conditions, behaving in the same way as the conventional non-GE counterpart; that it will be managed in an agronomic manner similar to any GE or conventional hybrid/variety of the species; another aspect is that Paraguay is not center of origin of that crop, and finally two relevant characteristics are that there are no related weeds in Paraguay with which the GE crop could cross-breed and that the main target pests and the main non-target arthropod species present in Paraguay have been taken into account in the GE risk assessment carried out in those countries.
The Commercial Release Opinion of the National Commission for Agricultural and Forestry Biosafety (CONBIO), in its substantial part states: "...Recommends technically: (1) The commercial release of the event T25 (2) In case of detection of an unexpected effect, the company is obliged to inform CONBIO". |
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Paraguay’s Path Toward the Simplification of Procedures in the Approval of GE Crops
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E-mail:
Organization/agency name (Full name): Ministerio de Agricultura y Ganadería
Contact person name: Santiago Bertoni
Website:
Physical full address: Yegros 437 entre 25 de mayo y Cerro Cora
Phone number: +595 981 256262
Fax number:
Country introduction: The agricultural sector is one of the economic pillars of Paraguay in its contribution to the GDP, with the main crops being soybean, cassava, maize, wheat, sugar cane, and cotton. It should also be noted that Paraguay is the world’s fourth exporter of soybean. In 2020, the area planted with crops was 4.67 million hectares and consisted of soybean (3.56 million hectares), maize (1.08 million hectares), and cotton (18,000 hectares). Agricultural biotechnology was first regulated in Paraguay in 1997. In 2012, the system was adjusted through the creation of the National Agricultural and Forestry Biosafety Commission (CONBIO), “with the mission to manage, analyze, and issue recommendations on all matters related to the introduction, confined field trials, pre-commercial and commercial release, and other intended uses of GE crops” Almost 94% of the soybean, 36% of the maize, and 56% of the cotton planted in the country are GE. Useful links
Relevant documents
Stacked events: When a stacked event is approved, all possible combinations are approved. Previously evaluated single events are not reevaluated in stacks. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: In 2012, the system was adjusted through the creation of the National Agricultural and Forestry Biosafety Commission (CONBIO), “with the mission to manage, analyze, and issue recommendations on all matters related to the introduction, confined field trials, pre-commercial and commercial release, and other intended uses of GE crops”. Additional information https://conbio.mag.gov.py/
| Name of product applicant: |
Bayer CropScience Inc |
| Summary of application: |
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| Date of authorization: |
21/06/2021 |
| 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.): |
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| Summary of the safety assessment (food safety): |
Corn T25 has been evaluated according to safety assessment by concerned agencies of the Department of Agriculture, such as the Bureau of Animal Industry (BAI) for feed safety, and Bureau of Fisheries and Product Standards (BAFPS) for food safety, and a Scientific Technical Review Panel (STRP) members. The process involves an intensive analysis of the nature of the genetic modification together with a consideration of general safety issues, toxicological and nutritional issues associated with the modified corn
The petitioner/applicant published the Public Information Sheet (PIS) of the said application in two widely circulated newspapers to solicit comments from the public. During the 30-day posting period, the Bureau of Plant Industry (BPI) received no comment on the petition.
The STRP and agencies’ assessment and review of results of evaluation by the BPI Biotech Core Team in consultation with DA-Biotechnology Advisory Team (DA-BAT) completed the approval process.
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August 21, 2024 |
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: |
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| Date of authorization: |
30/12/2003 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
Please see the link below(in Korean). |
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E-mail:
Organization/agency name (Full name): Ministry of Food and Drug Safety
Contact person name:
Website:
Physical full address: Osong Health Technology Administration Complex, 187, Osongsaengmyeong 2-ro, Osong-eup, Cheongwon-gun, Chungcheonbuk-do, 363-700, Korea
Phone number: 82-43-719-2360
Fax number:
Country introduction:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
Bayer CropScience AG |
| Summary of application: |
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| Date of authorization: |
05/09/2001 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
By all examined parameters, the data of complex safety assessment of transgenic
maize line T25 tolerant to glufosinate ammonium attest to the absence
of any toxic, genotoxic, immune system modulating, or allergenic effects of
this maize line. By chemical composition, transgenic maize line T25 was
identical to conventional maize.
Based on the results of the studies, the State Sanitation Service of the
Russian Federation (Department of State Sanitation and Epidemiological
Inspectorate) granted the Registration Certificate which allows the transgenic
maize line T25 to be used in the food industry and placed on the market
without restrictions.
More information is on P. 205-221 of monograph ”Genetically Modified Food Sources. Safety Assessment and Control”, published by Elsevier Inc. Academic Press in 2013,
the uploaded file.
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E-mail:
Organization/agency name (Full name): FSBI «Institute of Nutrition» RAMS
Contact person name: Nadezhda Tyshko
Website:
Physical full address: 109240, Russia, Moscow, Ustinsky Proezd, 2/14
Phone number: +7(495)698-53-64
Fax number:
Country introduction: The development of the GMO safety assessment currently used in the Russian Federation started in 1995–1996. The methodological approaches to comprehensive complex medical and biological assessment of GMOs were developed in the Russian Federation with due regard for international and national experience as well as new scientific approaches based on the achievements of contemporary fundamental science: genomic and proteomic analysis, detection of DNA damage or mutagenic activity, identification of products of free-radical modifications of DNA or other sensitive biomarkers. GMO safety assessment is carried out for the state registration. Any novel food derived from plant GMO produced in Russia or imported into Russia for the first time is subject to the state registration . Guidance for safety assessment is specified in MU 2.3.2.2306-07 “Medico-Biological Safety Assessment of Plant Genetically Modified Organisms”. According to the accepted regulations,the human health assessment of a novel GMO to be placed on the domestic market includes the following: ■ Molecular assessment includes analysis of genetic construction, genetic modification method, and the gene expression level. ■ Technological assessment includes determination of organoleptic and functional properties, analysis of technological characteristics of the finished products. ■ Human health safety assessment includes several sections of required assessments: analysis of compositional equivalence and toxicological,genotoxicological, and allergological safety studies. ■ Methods for identification include qualitative and quantitative assay of GMO in food (studies targeted at determination of correspondence of these methods to those used in Russia in order to provide monitoring of use and labeling of GM food). The list and the scope of required studies is determined on the basis of analysis of information of the GMO submitted for registration; however, the above-mentioned studies are required. If significant changes in the GMO’s genome, proteome, or metabolome are shown, additional studies may be required to determine: biological value and absorbency reproductive effect; gonadotoxic, embryotoxic, teratotoxic effect; potential carcinogenic effect; lifetime, etc. Useful links
Relevant documents
Stacked events: Russia follows the national Methodical Guidelines 2.3.2.3388-16 “Medical and biological safety assessment of genetically modified stack events of plant origin ”
Our position regarding GM stacks registration is very close to the EU approach.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Federal Research Centre of nutrition and biotechnology Viktor A. Tutelyan Ustinsky proezd, 2/14 109240 Moscow, RUSSIA E-mail: [email protected] Tel.:+7 495 698-53-60
| Name of product applicant: |
Bayer CropScience |
| Summary of application: |
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| Date of authorization: |
27/08/2014 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
Maize line T25 was developed through a specific genetic modification to allow the use of glufosinate ammonium. The pat gene, conferring tolerance to glufosinate ammonium, was cloned from the common aerobic soil actinomycete, Streptomyces viridochromogenes, and encodes the enzyme phosphinothricin-N-acetyltransferase (PAT). A single copy of the pat gene was transferred to corn resulting in the development of herbicide tolerant (glufosinate ammonium) corn line T25. Segregation analyses indicate that the transferred DNA is integrated into the corn genome as a single and stable insert. There was no evidence of toxicity for PAT protein. The PAT protein does not possess characteristics of known protein allergens and is unlikely to be allergenic. The nutritional qualities of cone line T25 were found to be comparable to the conventional corn lines. T25 is equivalent to food derived from other commercial varieties of corn in terms of its safety and nutritional adequacy. |
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E-mail:
Organization/agency name (Full name): Singapore Food Agency (SFA)
Contact person name: Dr Tan Yong Quan
Website:
Physical full address: 52 Jurong Gateway Road 14-01 JEM Office Tower Singapore 608550
Phone number: (65)68052750
Fax number:
Country introduction: The Singapore Food Agency (SFA) is a Statutory Board established under the Ministry of Sustainability and the Environment (MSE) to oversee food safety and security. SFA’s mission is to ensure and secure a supply of safe food. SFA adopts a risk-based approach to food safety. Foods with foodborne hazards that may pose potential food safety risks to consumers are subjected to more stringent checks, regardless of their country of origin. SFA has in place an integrated system to ensure that both imported and domestically produced foods are safe for consumption. The system comprises control measures such as source accreditation, inspection and surveillance of food, laboratory analysis, food legislation and recall of food products, which safeguard food safety from farm to fork. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Singapore Food Agency (SFA)
| Name of product applicant: |
BASF (Thai) Limited |
| Summary of application: |
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| Date of authorization: |
04/12/2022 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
The food safety assessment performed by the National Center for Genetic Engineering and Biotechnology (BIOTEC) as advisory and technical arm of Thai FDA. BIOTEC conduct food safety assessment according to codex guideline and based on the safety data and information provided by the applicant (as specified in Annex 2 attached to Notification of the Ministry of Public Health No.431). According to the existing scientific data and information available during the safety assessment, it is concluded that the maize event T25 is substantially equivalent to its conventional counterpart in terms of morphology, nutrition, toxicity and allergenicity. |
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E-mail:
Organization/agency name (Full name): National Burequ of Agricultural Commodity and Food
Contact person name: Director of Office of Standard Development
Website:
Physical full address: 50 Phahonyothin Rd., Lardyao, Chathuchak, Bangkok 10900
Phone number: +6625612277 ext.1401
Fax number: +6625613373
Country introduction: National Bureau of Agricultural Commodity and Food Standards (ACFS) is a governmental agency under the Ministry of Agriculture and Cooperatives (MOAC) responsible for the development of national agricultural and food standards. The Agricultural Standards Act B.E. 2551 (2008) establishes the mechanisms for the development of Thai Agricultural Standards (TAS) as either voluntary or mandatory standards. This is based on scientific data, consumer’s health and fair trade. Within the TAS, there are four standards relating GM food assessment, namely Principle for the Risk Analysis of Foods Derived from Biotechnology (TAS 9010-2006), Assessment of Possible Allergenicity (TAS 9011-2006), Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (TAS 9012-2006) and Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms (TAS 9013-2006). These standards are adapted from relevant Codex standards. Safety assessment for imported GM crops and foods is done by the cooperation of the Food and Drug Administration (FDA) and the National Center for Genetic Engineering and Biotechnology (BIOTEC)via the Committees relating National Committees to consider technical and political issues. The Committees comprise representatives from all relevant governmental and non-governmental key sectors including experts on genetic modification, toxicity and others.
The safety assessment process of GM food in Thailand is on a voluntary basis. According to the current laws and regulations, there is no approval authority. Useful links
Relevant documents
Stacked events: The safety assessment for stacked events is divided into two patterns. The first pattern is for stacked events whose GM parents have never approved by FDA or other competent authority. Those stacked events shall be fully assessed in line with GM foods. Another pattern is introduced for the safety assessment of stacked event lines where from GM parents had already been approved. In the second pattern, the information of the parents could be used for consideration, as appropriate. However, the information relevant to interaction between genes and new proteins of stacked event should be mainly taken into account. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Food and Drug Administration (FDA) and National Center for Genetic Engineering and Biotechnology (BIOTEC)
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Special case: please show below |
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| Date of authorization: |
16/07/2015 |
| 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.): |
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| 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 maize T25 and products thereof for animal feed.
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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: |
Corn
Trait 1 Added Protein: Phosphinothricin acetyltransferase (PAT)
Source: Streptomyces viridochromogenes
Intended Effect: Tolerance to the herbicide glufosinate-ammonium
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| Date of authorization: |
14/12/1995 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
Please consult the FDA website links below. |
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
FDA's webpage regarding this variety
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E-mail:
Organization/agency name (Full name): Food and Drug Administration
Contact person name: Jason Dietz
Website:
Physical full address: 5100 Paint Branch Parkway, College Park MD 20740
Phone number: 240-402-2282
Fax number:
Country introduction: The United States is currently in the process of populating this database. The Food and Drug Administration regulates food and feed (food for humans and animals) from genetically engineered crops in conjunction with the Environmental Protection Agency (EPA). EPA regulates pesticides, including those that are plant incorporated protectants genetically engineered into food crops, to make sure that pesticide residues are safe for human and animal consumption and do not pose unreasonable risks of harm to human health or the environment. FDA In the Federal Register of May 29, 1992 (57 FR 22984), FDA published its "Statement of Policy: Foods Derived from New Plant Varieties" (the 1992 policy). The 1992 policy clarified the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act with respect to human and animal foods derived from new plant varieties and provided guidance to industry on scientific and regulatory issues related to these foods. The 1992 policy applied to all foods derived from all new plant varieties, including varieties that are developed using genetic engineering (also known as recombinant deoxyribonucleic acid (rDNA) technology). In the 1992 policy, FDA recommended that developers consult with FDA about foods from genetically engineered plants under development and developers have routinely done so. In June 1996, FDA provided additional guidance to industry on procedures for these consultations (the consultation procedures). These procedures describe a process in which a developer who intends to commercialize food from a genetically engineered plant meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the genetically engineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food. FDA evaluates the submission and if FDA has questions about the summary provided, it requests clarification from the developer. At the conclusion of the consultation FDA responds to the developer by letter. The approach to the safety assessment of genetically engineered food recommended by FDA during consultations, including data and information evaluated, is consistent with that described in the Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants. EPA The safe use of pesticidal substances is regulated by EPA. Food from a genetically engineered plant that is the subject of a consultation with FDA may contain an introduced pesticidal substance, also known as a plant-incorporated protectant (PIP), that is subject to food (food for humans and animals) safety and environmental review by EPA. PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. Both the PIP protein and its genetic material are regulated by EPA. When assessing the potential risks of PIPs, EPA requires studies examining numerous factors, such as risks to human health, non-target organisms and the environment, potential for gene flow, and insect resistance management plans, if needed. In regulating PIPs, decisions are based on scientific standards and input from academia, industry, other Federal agencies, and the public. Before the first PIP product was registered in 1995, EPA required that PIP products be thoroughly tested against human safety standards before they were used on human food and livestock feed crops. EPA scientists assessed a wide variety of potential effects associated with the use of PIPs, including toxicity, and allergenicity. These potential effects were evaluated in light of the public's potential exposures to these pesticides, taking into account all potential combined sources of the exposure (food, drinking water, etc.) to determine the likelihood that a person exposed at these levels would be predisposed to a health risk. Based on its reviews of the scientific studies and often peer reviews by the Federal Insecticide, Fungicide and Rodenticide Scientific Advisory Panel, EPA determined that these genetically engineered PIP products, when used in accordance with approved label directions and use restrictions, would not pose unreasonable risk to human health and the environment during their time-limited registration. Useful links
Relevant documents
Stacked events: Stacked events that are each plant incorporated protectants, as defined by the Environmental Protection Agency, must be registered by the Envriornmental Protection Agency before they can be commercialized. Food/feed safety asssessment of single events are generally sufficient to ensure the safety of food/feed from stacked events. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
T 25 |
| Summary of application: |
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| Date of authorization: |
09/09/2015 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
T25 corn is as safe as and substantially equivalent to its conventional counterpart. It shows no different allergenic or toxic potential compared to conventional corn currently in the market. Compositional analyses of grains from T25 corn and current commercial corn 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 T25 corn is compositionally and nutritionally equivalent to currently grown conventional commercial corn varieties.
- The low potential for toxicity of the PAT protein expressed in T25 corn is demonstrated by examining the amino acid sequence homology, chemical characteristics of the protein and by acute oral toxicity testing. 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 T25 corn 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 enzyme.
- To date, no hazard related to T25 had been reported nor any risk could be identified in the past 18 years, thus necessitating not the need for any post-market monitoring and it has T25 corn has already been in the market for over 15 years with no reported concerns. T25 corn has been approved for food and feed uses in 17 countries worldwide. Therefore, it are no adverse effects assumed with use of T25 corn and as a consequence there is no need for a case specific monitoring plan relating to import of herbicide tolerant T25 corn. The grain derived from T25 needs no specific or additional treatment and will be handled in the same way as any other conventional corn commodity.
This application aims for food and feed use of herbicide-tolerant T25 corn in Vietnam. |
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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E-mail:
Organization/agency name (Full name): 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:
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