| Commodity: |
Corn / Maize |
| Traits: |
Lepidoptera resistance |
| Name of product applicant: |
Monsanto |
| Summary of application: |
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| Date of authorization: |
04/07/2017 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
EU Register of authorised GMOs
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| Summary of the safety assessment (food safety): |
Please see the EU relevant links below. |
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
Method for detection: Event-specific real-time PCR-based method for the quantification of MON-ØØ81Ø-6 maize. Reference Material: ERM-BF413 and ERM-AD413 accessible via the Joint Research Centre (JRC) of the European Commission. The relevant links are provided below. |
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Method for detection
Reference Material
Opinion of the European Food Safety Authority
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| Authorization expiration date (a blank field means there is no expiration date) |
03/07/2027 |
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: |
Monsanto Australia Ltd |
| Summary of application: |
One genetically modified corn line (MON 810) was generated by the transfer of the cry1A(b) gene into the parental line (genotype Hi-II) and confers protection against attack from insects. The protein product is an insecticidal crystal protein, whose toxic effect is specific to Lepidopteran insects, in this case the European Corn Borer.The insect-protected corn plant line is known commercially as Yieldgard corn as it is
protected against attack from Lepidopteran attack, particularly the European Corn Borer. The corn was developed by Monsanto Ltd for cultivation in the United States. Products derived from corn harvested from these plants may have been imported into Australia and New Zealand.
Domestic production of corn in both countries is supplemented by a small amount of
imported corn-based products, largely as high-fructose corn syrup, which is not currently manufactured in either Australia or New Zealand. Other products include maize starch which is used by the food industry for the manufacture of dessert mixes and canned foods and cornbased ingredients processed into breakfast cereals, baking products, extruded confectionary and corn chips. |
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| Date of authorization: |
07/12/2000 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
OECD BioTrack Product Database
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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 A346 - Food produced from insect protected corn line MON 810
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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: |
Monsanto do Brasil Ltda. |
| Summary of application: |
commercial release of genetically modified corn resistant to insects of the Lepidoptera order (Guardian Corn, Event MON810), as well as all the progenies coming from the
transformation event MON180, and its derivatives of crossing of lineages, and non—transgenic populations of corn with lineages bearing event MON810 |
| Upload: |
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| Date of authorization: |
16/08/2007 |
| 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): |
Event MON810. Integrated to its genome, Guardian corn that derives from lineage MON810, presents
gene cry1Ab, that comes from Bacillus thuringiensis subsp. kurstaki, which codifies protein Cry1Ab with toxic effect over insects of Lepidoptera order (Spodoptera frugiperda, earworm and Meromyza Americana). The transformation process consisted of the bombarding of vegetal material with
particles coated with the genetic material of interest, generating the corn lineage MON810 that contains gene cry1Ab of B. thuringiensis (classified as organism of risk class I of biosafety). The expression levels of protein Cry 1AB (also called Bt, from Bacillus thuringiensis) of lineage MON810 were evaluated on young leaves, grains, whole plant and pollen. The results showed the highest levels of expression on leaves (9.35 μg/g of dry weight), followed by the whole plant (4.31 μ/g of dry weight),
grains (0.31 μg/g of dry weight) and pollen (0.09 μg/g of dry weight). The protein is toxic only for the mentioned target insects, specifically to lepidopteron (worms) that exclusively have in their intestines specific receptors for this protein. Mammals do not have these receptors, or connection places, and, therefore, human beings, animals, and other organisms that are not target are not affected by
protein Bt, including other arthropods and also natural enemies of target-plagues. The protein sequence was compared to data banks of protein with allergenic properties, and no biologically meaningful homology was demonstrated between protein Cry1Ab as a whole and sequences of proteins with these properties. Due to digestibility characteristics of protein Cry1Ab on gastric and intestinal fluids, the probability that it presents allergenic action is extremely low. It is improbable that exogenous DNA may integrate itself to human genome, for DNA molecule is disintegrated during the digestion process, and would hardly stay intact to be used by the human or animal body cells. The introduction of gene cry1Ab did not result
on apparent alteration of nutritional importance, for the profiles of the main nutrients were similar to those
normally observed in other varieties, or under distinct conditions of cultivation. Thus, the results about chemical and centesimal composition of MON810 corn are in accordance with the Principle of Substantial Equivalence. Due to the smaller infestation by insects in relation to the traditional varieties of corn, there is less growth of associated fungus, micotoxins producers of pathologic importance for human beings and animals, and, consequently, considerably reducing the contamination and the presence of these toxins, contributing to improve the quality and food safety of grains. The possibility of transgenic plant, or
progenies coming from the crossing of lineage MON810 with other corn plants, to become weed species is minimum due to biological characteristics of the species, and to the fact that corn does not survive well without human intervention. Corn is an entirely domesticated plant, and needs the men to survive. Since the event introduced into corn does not have relation to the reproduction of the plant, or with its
interaction with the environment, it is expected that the transgenic corn Bt have environmental behavior similar to the common corn, having, therefore, no possibility of this corn to become an invasive plant or weed. B. thuringiensis is a soil microorganisms and the exposition of live organisms, and of the environment to this bacteria, or to any element extracted from it, is an event that occurs
abundantly in nature, not resulting in meaningful risk for the soil micro biota. Agriculturists, including those that prefer the so- called organic agriculture, have been spreading this bacteria for a long time over plants to avoid lepidopteron from destroying them. Various studies results have shown that corn MON810 does not cause negative impact over the community of non-targeted evaluated organisms. Information indicate that transgenic plants do not fundamentally differ from genotypes of untransformed corn, except for the resistance to insects of Lepidopteron order. The background of ten years of safe use of this
transgenic variety in the world points to great accumulation of trustworthy scientific information that
indicate that this variety is as safe for the environment, and for human and animal’s health as the hybrid corns varieties that have been being used. Additionally, there is no evidence of adverse reactions to the use of Guardian corn. For these reasons, there are no restrictions to the use of this corn, or of its derivatives for human or animal feeding.
CTNBio TECHNICAL OPINION
I. GMO Identification
Designation of GMO: Guardian Corn, Event MON810
Petitioner: Monsanto do Brasil Ltda.
Species: Zea mays – Corn
Inserted Characteristics: Resistance to insects of
Lepidoptera order
Method of characteristic introduction: Bombarding of
particles method
Proposed Use: Silage and grains Production for human and
animal consume of GMO and its derivatives.
II. General Information
Zea mays L., the corn, is a species that belongs to Maydae
tribe that is included in the sub-family Panicoideae,
Gramineae family (Poaceae). The genders belonging to Maydae
tribe include Zea and Tripsacum in the Western Hemisphere.
Corn is a separate species within Zea sub-gender, with chromosome number 2n = 20,21,22,24 (15). 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 corn produced can also be crossed with the most distant genre Tripsacum. This crossing, however, occurs with great difficulty and results
on sterile-male progeny. Corn history is over eight thousand years old in the Americas. Out of all the cultivated plants, it is probably the one that has the greatest genetic variety. Today, there are around 300 races of corn, and within each race, thousands of crops. Corn is nowadays, the cultivated
species that reached the highest degree of domestication and only survives in nature when it is cultivated by men(6). 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 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 over 100 countries, with a total production estimated in 705 million tons/year. Corn is one of the most important sources of food in the world, and is raw material for the production of a wide range of products. In the productive chain of swine and
poultry, approximately 70 to 80% of the corn produced in Brazil is consumed. Brazil is the third biggest corn producer in the world with a production of approximately 35 million tons in 2005, behind only of the United states of America (282 million tons), and China (139 million tons)(19). In Brazil, corn is basically planted in two crops (summer plantation, and small crop), and it is cultivated practically all over the
national territory, being 92% of the production in the South (47% of production), Southeast (21% of production) and Center-West (24% of production). In the last years, insects have become plagues that limit
the corn culture in Brazil, especially insects of Lepidoptera order (Spodoptera frugiperda, earworm and
Meromyza Americana). It is estimated that they may cause damages of up to 34% on the production of corn grains. With the increase of the area cultivated with corn during the so-called “small crop” (three million hectares), closing the cycle of various plagues and diseases, the problema became bigger. In some areas of the Brazilian Center-West, it is necessary dozens of pulverizations with insecticides
in only one cycle of cultivation. Brazil is the third biggest consumer of agricultural defensives in the world. Nowadays, we have 142 registered agro toxics for corn, 107 only for worms. There are already
many cases of resistance for the constant and indiscriminate use of insecticides in corn culture in
Brazil. What’s more, one of the factors that mostly affects agriculturists’ health in Brazil is the use of agricultural defensives, which are responsible for the intoxication of a
million people every year.
Guardian corn, event MON810, consists of an alternative proposal for the control of worms, plagues of corn culture. It is based on the use of corn hybrids that derive from lineage MON810, genetically modified to be resistant to these worms attack. For this purpose, gene cry1Ab of Bacillus thuringiensis subsp. kurstaki (Bt), lineage HD-1 was inserted. The same lineage was used in commercial
formulations of B. thuringiensis of wide use in agriculture. Transgenic corn MON810 – Guardian Corn is
already cultivated, or commercialized in 14 countries (Argentina, Australia, Canada, China, European Union, Japan, Korea, Philippines, Mexico, South Africa, Switzerland, Taiwan, Uruguay and The United States of America). The event was developed with the introduction of gene cry1Ab of Bt in one corn lineage, through biobalistics process. The event expresses protein Cry1Ab, responsable for the death of worms during the whole vegetable cycle. This protein is specific for lepidopteron (worms), and does
not have toxic effect over dipterous (flies, bees, and others) or coleopterons (beetles, ladybugs and others). The protein produced on Bt corn is identical to the one found in nature, or in formulations for pulverizations available in the market for over 40 years. It is important to highlight that corn varieties containing this protein have been used in many countries in the world, and there is
no information that hybrids of corn containing cry genes have caused damage to the environment, or to human or other animal’s health.
In Brazil, many releases in the environment of Guardian corn, were conducted after approval by CTNBio in regions that represent the corn culture, including the states of São Paulo, Minas Gerais, Mato Grosso, Mato Grosso do Sul, Paraná, Goiás, Rio Grande do Sul, Distrito Federal, Santa
Catarina and Bahia.
III. Description of GMO and Expressed Proteins
The corn lineage MON810 was obtained through the genetic transformation, particles acceleration methodology or biobalistics, of plants of hybrid corn HI-II, resulting form the crossing of public lineages of corn A188 and B73, developed in the United States of America by the University of Minnesota, and by the University of the State of Iowa, respectively. According to the company’s information, the
genotypes represent around 50% of each material. These plants were transformed into vectors PV-ZMBK07 and PVZMGT10, generating the corn lineage MON810 that contains
gene cry1Ab of B. thuringiensis (classified as organism of risk class I of biosafety).
B. thuringiensis is a soil bacteria, gram-positive, initially isolated in Japan by Ishiata, and formally
described by Berliner in 1915. This microorganism forms crystals of endotoxins, proteins with insecticide action that act before and during the sporulation phase of its life cycle. Nowadays, there are many collections in the world that contain thousands of isolated B. thuringiensis, being many races classified based on their spectrum of action, their crystalline toxins and their genetic similarities.
Vector PV-ZMBK07 contains the gene that codifies endotoxin Cry1Ab, and vector PV-ZMGT10 contains genes cp4-epsps and gox. Gene cry 1Ab present in vector PV-ZMBK07 was put under control of transcriptional promoter E35S (around 0.6 kb). An intron of 0.8kb deriving from gene hsp70 of corn was
also inserted between the promoter and the gene cry1Ab.
This insertion was made in order to increase the levels of transgenic expression. To the reflux of the gene cry1Ab was put the sequence 3’-UTR (transcribed, but not translated) of 0.26 kb of nopaline synthase, which contains the signal of polyadenylation. The sequence of gene cry1Ab is composed
by 3468 nucleotides, and codifies one protein of B. thuringiensis sbsp. kurstaki HD-1 (Cry1Ab) of 1156 amino acids. To allow adequate levels of expression in corn, the sequence of gene was modified to adjust the use of códons and proportion A + T. Thus, the proteic sequence did not differ from the one obtained from B. thuringiensis. The molecular characterization was executed to identify the presence of vectors PV-ZMBK07 and PV-ZMGT10 on the genome of transformed corn plants, besides the number of copies
integrated to the genome. The molecular characterization of lineage MON810 was made by Southern Blot, indicating the integration of a sole copy of gene cry1Ab with the promoter 35S and the intron of corn hsp70 without any residue of sequences of the vector or of the gene nptll, of resistance to neomycin. Also, it was noticed the absence of genes gox and cp4-epsps of the construction on vector PV-ZMGT10. The absence o additional sequences on lineage MON810 restricts the evaluation of safety to the implications of the
presence of gene cry1Ab.
The genetic stability of elements present on vector PVZMBK07 was characterized from the execution of crossings, and evaluation of segregation of progenies derived from lineage MON810. The results indicate the occurrence of a sole functional insertion, in accordance with the Mendeliane Genetic. According to information present on the process, gene cry1Ab showed to be stable for seven generations of crossings with one of its recurrent parent (B73), and for six generations of crossings with a nonparental lineage (Mo17). These data were also confirmed from the hybridizations with a probe formed by part of gene
cry1Ab.
The mechanism of action of toxins Cry have been extensively studied in lepidopteron, dipterous, and coleopterons. On the alkaline pH of insects’ intestines, proteins crystals ingested are dissolved, and the pro-toxins are ctivated by digestive proteinases of insects. The mechanism of action of proteins Cry revealed by Broderick and collaborators(9) indicates that the toxin Cry makes the intestinal epitheliums permeable, allowing bacteria of the digestive treat to contaminate hemolynpha, leading to a
septicemia picture and death of the worm.
The expression levels of protein cry1Ab on the lineage MON810 were evaluated in young leaves, grains, whole plant and pollen. Materials were collected in six places in the United States of America, and the levels o expression of the protein were evaluated by ELISA and Western blot. The results showed the highest levels of expression on leaves (9.35 μg/g of dry weight), followed by the whole plant (4.31 μg/g of dry weight), grains (0.31 μg/g of dry weight), and pollen (0.09 μg/g of dry weight). Later on, the transfer of the cassette of expression containing the gene cry1Ab for tropical germoplasm of corn was executed.
The first introductions of more adapted materials, or materials in phase of adaptation, were made in Brazil in 1998. According to the petitioner, these requests aimed at experimenting lineages derived from MON810 in Brazil and roceed to the introgression of the gene in improvement programs. To confirm the introgression of the cassette of expression on tropical lineages, an experiment of Southern
blot was executed, and it identified the presence of the transgene on the sample genotypes.
IV. Aspects Related to Human and Animals’ Health The evaluation of safety of foods derived from genetically modified raw material is based on risk analysis, scientific methodology that encompass the phases of evaluation, management and risk communication. 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
specifically: (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 inserted gene product and the potential toxicity and allergenicity, and; (4) the composition of the new variety deriving from the genetic transformation. The group of data of this analysis should allow for the identification and characterization of the potential adverse effects
associated to the consume of the new raw-material, subsidizing the phases of management and risk
communication. Z. mays is a well characterized species, having solid background of safety for human consume. During the process a considerable volume of information is presented, including the origin, domestication, identity, taxonomy, morphology, genetics hybridization and crossing, that reflect the profound degree of knowledge around this species.
Cultures of B. thuringiensis are registered at the National Health Surveillance Agency – ANVISA under diferente formulations for application in 30 kinds of vegetable cultures for food use. They are included on the toxicological classification of group IV, and there is no determined maximum limit of residues and safety interval.
In the process, it is mentioned that the sequence of gene cry1ab of B. thuringiensis was modified to provide high expression on corn, without, however, modifying the amino acids sequence. This alteration does not imply on increased risk, due to the variation on the repertoire of common bases to the genetic code of organisms. The transformation process consisted of the bombarding of vegetal material with particles coated with genetic material of interest. Once this is a physical process of DNA molecules transfer, that does not count with intermediation of any biological agent, and is executed with asepsis conditions, it is practically little the chances of having DNA molecules, other than those of the
genic construction present on particles, transferred to vegetable cells.
Protein Cry1Ab is a á-endotoxin, produced by B. thuringiensis that presents specific activity over the
digestive system of some family of insects. For its activity, the protein should be ingested by insects, whose stomach pH is capable of solubilizing protein. Under the proteases action, the protein is transformed on the activated form that is linked to specific receptors of high affinity present in insects and absent in mammals. The protein is only toxic for the mentioned target insects, more specifically to lepidopteron (worms), who have in their intestines, specific receptors for this protein. Mammals do not have such places of linkage, and, therefore, human beings, animals and other untargeted organisms are
not affected by protein Bt, including other arthropods and also natural enemies of target-plagues. Studies were conducted to evaluate the toxicity of corn MON810, and of protein Cry1Ab. Quails were fed with grains of corn of lineage MON810 with up to 10% of weight of bran of corn whole grains on the diet, and adverse or toxic effects have not been observed. Sanden and collaborators (37) concluded that corn MON810, added to 12% of fish food, are as safe as non-transgenic varieties, evaluating parameters of the intestinal treat of Atlantic salmon. Studies of food safety for mammals were carried out with the protein expressed in E. coli that turned out to be chemical and functionally equivalent to the one expressed
on lineage MON810, as well as in a formulation of microbial plaguecide (DIPEL) containing B. thuringiensis. Studies of acute oral toxicity for rats showed that the level reached, without noted effects, was 4000 mg/Kg of body weight being proposed a DL50 over this value. A recent published study that evaluated the sub-chronic toxicity (90 days) of Guardian corn in rats demonstrated that adding corn MON810 on levels of 11% and 33% to balanced diets did not bring any alterations to animals fed with the genetically modified variety, when compared to the non-modified lineage(24). Shimada and collaborators(39) demonstrated the absence of toxicity of protein Cry1Ab over culture of isolated hepatocites of bovine suggesting that the protein has low acute toxicity for mammal’s cells. Protein Cry1Ab does not present allergenicity characteristics, besides being degraded in the gastrointestinal system of mammals. Data available in literature(41) have indicated normal digestibility for the varieties of transgenic corn released for human consume. Okunuki and collaborators(34) argue that the protein allergenicity, if any, should be meaningless due to the digestibility characteristics of protein Cry1Ab in gastric and intestinal fluids. These authors demonstrate also that after being heated, the degradation is faster, what
suggests a smaller concentration of protein in foods based on corn that are heated during the processing.
The protein sequence was compared to data banks of proteins with allergenic properties. Meaningful biologically homology was not demonstrated between the complete protein Cry1Ab and sequences of proteins with these known proteins at the time of this process presentation. To check the allergenic potential of proteins extracted from the transgenic corn MON810, and of protein Cry1Ab, Batista and collaborators(7) evaluated two sensitive populations of individuals, through skin tests: children
with inhaling allergy, and allergy to foods , and individuals with asthma-rhinitis. Besides, they also
evaluated IgE levels in serum of individuals allergic to corn and pure transgenic proteins (Cry1Ab). Authors
concluded that the transgenic evaluated regarding the allergenic potential are safe. Similar results were
observed by Nakajima and collaborators(31) in patients with allergy to foods. In these patients, no meaningful levels of specific IgE against Cry1Ab in serum were found. The analysis of chemical composition of the variety obtained through transgene, mainly the levels of its nutrients and of 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 did not compromise its safety, nor resulted in non-intended effects. International data presented on the process
include the centesimal composition, profile of amino acids and fatty acids of genetically modified variety, and of cultivated parental varieties, under the same conditions, in the United States (1994), Italy, France (1995). In general, for all the analyzed parameters, there was no meaningful difference between the genetically modified variety, and its respective conventional counter-part, or the differences were within the variety normally noted in corn. Thus, it is possible to consider that the introduction of gene cry1Ab has not resulted on apparent alteration of nutritional importance, for the profiles of the main nutrients were similar to those normally conserved in other varieties, or under different conditions of cultivation.
In Brazil, there were analysis of centesimal composition of two hybrids derived from the lineage MON810, C806-guardian, cultivated in the municipalities of Campo Novo dos Parecis (MT), Uberaba (MG), and Pirassununga (SP) on the 1998-1999 crop. Similarly to what was observed for corn samples of lineage MON810 cultivated abroad, there was no meaningful difference in relation to the conventional variety, or the differences were within the variability normally found in corn. Data suggest that, also on plants cultivated in Brazil, the introduction of gene cry1Ab has not resulted on apparent nutritional alteration. Thus, results about chemical and centesimal composition of corn 810 are in accordance with the Principle of Substantial Equivalence that affirms that, if food is modified by any technique and has the same chemical and physical composition, texture, nutritional value, and does not present toxic substance
different from the original food, these foods are substantially equivalent, and, therefore, should not be
differentiated or segregated. According to Codex Alimentarius, the Principle of Substantial Equivalence is a key element on the process of innocuousness evaluation of new food in relation to its conventional homologous. It is relevant to consider that the protection given to grains by toxin Bt against damages of worms on the spike drastically reduces the incidence of rancid grains. The presence of rancid grains is associated to production of micotoxins, and it is a serious problem on corn. Thus, the smaller observed infestation by insects brings as consequence a smaller growth of fungus that produce micotoxins of pathologic importance for humans and animals, considerably reducing contamination, and consequently, the presence of such toxins (22,23,28,35,43,44), contributing to improve the quality and level of food safety of grains.
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 help of the wind, insects, gravity and others. The introduction of genic elements previously described has not altered the reproductive characteristics of the plant. Therefore, the same chances of crossed fecundation that occur between
hybrids and conventional corn lineages - not genetically modified - will occur between plants of event MON810 and other corn plants.
Corn genic flow may occur through pollen transfer and sedes dispersion. Seeds dispersion is easily controlled, once corn domestication eliminated the ancient mechanisms of seeds dispersion, and pollen movement is the only effective mean of corn plants genes escape.
Studies about corn pollen dispersion have been conducted, and some of them show that corn pollen may travel long istances. 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 and collaborators have evaluated the distance of isolation and control of pollen, and have demonstrated 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 the viability of pollen is kept for 2h, and that crossed pollination was not observed in 300 meters distances from the pollen source. Comparing the concentrations at 1 m of source culture,
under low to moderate winds, it was estimated that approximately 2% of pollen is 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 área 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 is minimized, and the presence of any genetic materials resistant to insects is improbable. Corn is an allogamous and annual plant, the predominant pollination agent for corn is the wind and the distance that pollen may travel depends on wind patterns, humidity and temperature. Corn pollen is dispersed freely around the area cultivated with this gramineae, and it may reach the stigma-style of the same genotype, or of different genotypes, and in adequate conditions, it starts its germination, originating the pollinic tube that promotes fecundation of the ovule within the average period of 24 hours.
The possibility of the transgenic plant to become a weed, as well as the lineage crossing MON810 with other corn plants, to originate a weed is very low, due to the biological characteristics of the species, and to the fact that corn does not survive without men intervention, result of the selection made during its evolution. Corn is the species that reached the highest degree of domestication among cultivated plants, having lost its survival characteristics in nature, such as, for example, degrana elimination. Thus, corn is a plant that is incapable of surviving in natural conditions, when not technically assisted. So, it is expected that transgenic Bt corn has an environmental behavior similar to the common corn, therefore, there is no possibility that corn is transformed into an invasive plant or weed. The possibility of gene cry1Ab of the transgenic plant pass to other organisms, as for example, soil microorganisms is practically null (32, 40). Once B. thuringiensis is a soil microorganisms, the expositions of live organisms, and of the environment to this bacteria, or to any elemento extracted from it, is an event that occurs abundantly in nature, not resulting in meaningful risk for the soil micro biota.
Another remote possibility is the transfer of exogenous DNA to the human being that would consume corn MON810. Depending on the composition of the ingested food, the amount of DNA ingested by a person varies between 0.1 and 1.0 per day. The gene inserted into corn MON810 represents a quantity 20,000 times smaller than this. Besides, DNA molecule is disintegrated during the digestion impeding it to be absorbed as a whole by intestine cells, likewise, men and animal do not absorb DNA of billions of bacteria that live in the intestine, or of any non-transgenic food. Additionally, commercial formulations of B. thuringiensis containing these proteins have been being used in Brazil and in other countries for the control of some agricultural plagues for 40 years. Due to its insecticides properties, spray products based on Bt are the most efficacious commercial bio-insecticides used for protecting crops, and forests, and they start to substitute the measures of conventional control that present practical limitations(14). Nowadays, bio-pesticides based on toxin Bt represent around 90% of the world market of bio-pesticides, being widely used as an alternative to chemical insecticides in terms of safety to untargeted organisms,
and when there is the development of resistance to chemical insecticides. Cry1Ab protein safety was tested for the following organisms: bees (Apis melifera L.) in larvae and adults, benefic pollinizer; crisopideo (Cryperla carnea) benefic predator; a hymenoptera (Brachymeria intermedia),
parasitoid benefic insect of the domestic fly; ladybug (Hippodamia convergens) benefic predator insect; worms (Esenia fétida); micro-crustaceous of aquatic environments, Daphnia magna. Field studies carried out in Brazil, about insect populations present in transgenic corn plantations derived from the lineage MON810, showed that the presence of natural enemies, and of non-target insects in these fields is similar. Field essays made for the evaluation of insects population dynamics, such as beetles, ladybugs (Coleopteran), syrphidae (Dipteral), bugs (Hemiptera) have not demonstrated meaningful impacts on entomofauna of the studied regions.
Corn MON810 has not present effect over the population dynamics of the predominant species of spiders and benefic insects of different trophic guilds either, including nontarget plagues and benefic insects (Carabidae, Coccinellidae, Chrysopidae, Hemerobiidae, Syrphidae, Tachinidae and Apidae). The bees’ population, A. mellifera, was bigger in the evaluated areas. This result may be explained this way: (1) protein Cry1Ab does not act in the digestive system of the bees, for it is specific only for some lepidopteron species; (2) bees freely feed from the pollen for the smaller use of insecticides on corn MON810
plantations.
Two doctorate theses analyze the possible impacts caused by corn MON810 over the different taxonomic groups that represent biodiversity of Brazilian agro-system where corn plantation is carried out. The main conclusion was that corn MON810 does not have negative impact over the evaluated insects’ community.
Data available in literature corroborate to the results found, and are also evidence that among the
advantages of use of cry gene, in relation to other control methods of lepidopteron, is the absence of negative effects in non-target insects, mammals and human beings, the high specificity and efficiency against target-insects, the environmental degradability, and the safety of manipulation and use.
One should highlight that any insects control measure that allow for the reduction on the use of chemical defensives should be considered as a priority under the point of view of environmental and nutritional safety. 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 indicates that transgenic plants do not fundamentally differ from non transformed corn genotypes, except for resistance to insects of Lepidoptera order. Additionally, there is no evidence of adverse reactions to the use of Guardian corn. Thus, there is no restriction to the use of this corn, or of its derivatives to human or animal feeding.
The vertical gene flow for local varieties (called creoles corn) 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 genetic improvement process). The coexistence between conventional corns cultivation (improved or creoles), and transgenic cultivations of corns is possible from the agronomic point of view
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
Molecular traditional Methods |
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
National Biosafety Comission
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Not Aplicable |
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: |
Monsanto Canada Inc. |
| Summary of application: |
MON810 offers the Canadian grower protection against the loss of yield due to infestation with the European Corn Borer (ECB), a damaging lepidopteran insect pest in Canadian corn production.
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| Date of authorization: |
17/02/1997 |
| 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: |
Monsanto Company |
| Summary of application: |
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| Date of authorization: |
20/02/2004 |
| 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. 2122-16-2014: Detection of genetically modified plants and derived products
Qualitative PCR method for insect-resisteant maize MON810 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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20/2/2007 |
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: |
PT. Bayer Indonesia |
| Summary of application: |
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| Date of authorization: |
10/05/2022 |
| 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): |
Indonesia National Agency of Drug and Food certified food safety for GM Maize event MON 810 (resistance to Lepidoptera) |
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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: |
Kenya Agricultral Research Organization and African Agricultural Research Foundation (AATF) |
| Summary of application: |
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| Date of authorization: |
28/01/2016 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
Biosafety Clearing House
Organization for Economic Cooperation and Development (OECD)
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| Summary of the safety assessment (food safety): |
See attachment |
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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: |
PCR based method for detection of the product is as provided in the link below to EU Database of Reference Methods for GMO Analysis
URL: http://gmo-crl.jrc.ec.europa.eu/gmomethods/
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Biosafety Clearing House
Organization for economic Cooperation and Development (OECD)
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| Authorization expiration date (a blank field means there is no expiration date) |
28/01/2021 |
E-mail:
Organization/agency name (Full name): Kenya Bureau of Standards
Contact person name: Danset Moranga
Website:
Physical full address: Kenya Bureau of Standards Popo Road, Off Mombasa Road
Phone number: 0723549062
Fax number:
Country introduction: The National Biosafety Authority (NBA) was established pursuant to the provisions of the Biosafety Act No. 2 of 2009. The overarching mandate of NBA is to exercise general supervision and control over development, transfer, handling and use of genetically modified organisms (GMOs) so as to ensure safety of human and animal health and provide adequate protection of the environment. NBA is the competent authority of the Government of the Republic of Kenya and is the Focal Point of the Cartegena Protocol on Biosafety.. The Authority regulates all activities involving GMOs in food, feed, research, industry, trade and environmental release. Since its inception in 2010, the Authority has developed a number of Regulations such as the Contained use Regulations, 2011 to guide research on GMOs, the Environmental release Regulations, 2011, Import, Export and Transit Regulations, 2011.The latest Regulations on Labelling GMOs that came into force as from May 2012 is intended to ensure that GMOs are clearly labelled so that consumers are made aware that the food, feed or product is genetically modified so that they can make informed choices and also to facilitate the traceability. 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, RED HILL ROAD, OFF LIMURU ROAD, P.O. BOX 28251, 00100, NAIROBI, KENYA
| Name of product applicant: |
Monsanto |
| Summary of application: |
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| Date of authorization: |
19/09/2008 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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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| Authorization expiration date (a blank field means there is no expiration date) |
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E-mail:
Organization/agency name (Full name): Department of Biosafety Malaysia
Contact person name: Dr. Anita Anthonysamy
Website:
Physical full address: Department of Biosafety,
Ministry of Natural Resources, Environment and Climate Change
Level 4, Block F11, Complex F
Lebuh Perdana Timur, Precinct 1
62000 Putrajaya, Malaysia
Phone number: +60380917322
Fax number: +60380917371
Country introduction: GM food safety assessment is a requirement by law under the Biosafety Act 2007 in Malaysia. The National Biosafety Board reviews and makes decisions on events based on a scientific/technical risk assessment, policy considerations as well as public input. The decisions and its related documents made are publicly available through the Malaysian Department of Biosafety Website and the Convention of Biological Diversity Biosafety Clearing House. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Department of Biosafety, Ministry of Natural Resources, 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: |
Monsanto Comercial, S.A. de C.V. |
| Summary of application: |
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| Date of authorization: |
06/11/2002 |
| 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.): |
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| Summary of the safety assessment (food safety): |
UI OECD: MON-ØØ81Ø-6
During the risk assessment of this GMO based on existing knowledge to date, no toxic or allergic effects neither substantial nutritional changes are observed. The event is as safe as its conventional counterpart.
For more detail please find attached the risk assessment summary in this page.
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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E-mail:
Organization/agency name (Full name): CIBIOGEM
Contact person name: Dra. Consuelo López López
Website:
Physical full address: San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number: +52 (55) 53227700
Fax number:
Country introduction: México ha buscado garantizar la inocuidad de los productos biotecnológicos para el uso y consumo de su población.
Desde 1984 el artículo 282 bis 1 de la Ley General de Salud, contempló que la Secretaría de Salud debería regular aquellos productos biotecnológicos, o sus derivados, destinados al uso o consumo humano.
En un inicio, con fundamento en este artículo, la Secretaria de Salud evaluó la inocuidad alimentaria de productos biotecnológicos, para su comercialización con fines de uso o consumo humano. A partir de 2005, con la entrada en vigor de la Ley de Bioseguridad de Organismos Genéticamente Modificados (LBOGM), se realizó la adecuación de la regulación para dar lugar a la Autorización que es el acto administrativo mediante el cual la Secretaría de Salud, a través de la Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), autoriza Organismos Genéticamente Modificados (OGMs), a efecto de que se pueda realizar su comercialización, así como su utilización con finalidades de Salud Pública o de Biorremediación.
Las facultades que corresponden a la Secretaría de Salud se estipulan en el artículo 16 de la LBOGM y lo relativo a la Autorizaciones se describe en los artículos 91 al 98 de dicha Ley.
Quienes pretendan obtener una Autorización para Comercialización e Importación de OGMs deben presentar ante COFEPRIS, una solicitud por escrito acompañada de la información a que se refiere los artículos 23 al 32 del Reglamento de la Ley de Bioseguridad de OGMs.
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf
Courtesy translation
Mexico has sought to guarantee the safety of biotechnological products the use and consumption of its population. Since 1984, article 282 bis 1 from the General Law of Health, considered that the Secretary of Health should regulate those biotechnological products, or their derivatives, intended for food and feed use. Initially, the Secretary of Health evaluated the food safety of biotechnological products, based on this article, for commercialization with purposes of food, feed and processing. Subsequently in 2005, with the entry into force of the Law on Biosafety of Genetically Modified Organisms (LBOGM), the regulation was adapted to give rise to the Authorization, which is the administrative act through which the Secretary of Health, by means of the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), authorizes Genetically Modified Organisms (GMOs), to their commercialization, as well as their use for purposes of public health or bioremediation.
The faculties that correspond to the Secretary of Health are stipulated in Article 16 of the LBOGM and what is related to the Authorizations is described in Articles 91 to 98 of this Law. Those who seek to obtain an Authorization for GMOs merchandising and importation, must present to COFEPRIS, a written request accompanied by the information referred into articles 23 to 32 of the Regulation of the Law on Biosafety of Genetically Modified Organisms.
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
Monsanto Australia Ltd |
| Summary of application: |
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| Date of authorization: |
20/12/2000 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
OECD BioTrack Product Database
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| Summary of the safety assessment (food safety): |
Insect-protected corn line MON 810 has been evaluated according to ANZFA’s safety
assessment guidelines. The process involves an extensive analysis of the nature of the
genetic modification together with a consideration of general safety issues, toxicological
issues and nutritional issues associated with the new GM food. This approach establishes
whether or not a food produced from GM corn is as safe and nutritious as food produced
from non-GM varieties.
The detailed information available on the genetic modification used to produce Yieldgard
corn indicates that no unintentional changes have taken place at the molecular level and that the novel genetic material is stably inserted and maintained over several generations.
Data on the potential toxicity and allergenicity of the protein encoded by the transferred gene have been reviewed, and indicate that the new protein expressed in insect-protected corn is non-toxic and unlikely to have allergenic effects.
Compositional analyses demonstrate no significant differences between insect-protected corn and its conventional counterparts. This constitutes further evidence that no unintentional effects have occurred as a result of the genetic modification.
In assessing all of the above data, ANZFA has concluded that insect-protected corn line
MON 810 does not raise any public health and safety concerns. |
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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 A346 - Food produced from insect protected corn line MON 810
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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: |
MONSANTO PARAGUAY S. A. |
| Summary of application: |
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| Date of authorization: |
24/10/2012 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
MON-ØØ81Ø-6
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| Summary of the safety assessment (food safety): |
The food and feed safety assessment was performed following the CODEX Guidelines. 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 MON 810 (2) In case of detection of an unexpected effect, the company is obliged to inform CONBIO". |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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| Authorization expiration date (a blank field means there is no expiration date) |
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E-mail:
Organization/agency name (Full name): 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: |
Monsanto Philippines |
| Summary of application: |
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| Date of authorization: |
23/02/2018 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
Monsanto Company has developed insect-protected corn event MON810 by inserting cry1Ab gene which naturally produces Bacillus thuringiensis (Bt) protein in the maize. MON810 is protected from feeding damage by Asian corn borer, European corn borer, the southwestern corn borer, and the pink borer. The benefits of planting the transgenic corn are: 1) a reliable means to control these major pests; 2) control target insects while not harming beneficial species; 3) reduced chemical pesticide usage; 4) reduced exposure of applicator; 5) a fit with the Integrated Pest Management (IPM) and sustainable agricultural systems; 6) reduced fumonisin mycotoxin level in corn kernels; and 7) no additional labor or machinery required, allowing both large and small growers to maximize hybrid yields. Additional to this, the quality of produce would be maintained and crop damage would be reduced thus more produce could be sold. The gene of interest was isolated from the Bacillus thuringiensis var. kurstaki HD-1 strain found in DIPEL, the leading microbial insecticide in agricultural use. This gene was bombarded in the embryonic corn tissue with plasmid PV-ZMBK07. Southern blot analysis of MON810 corn demonstrated that a single functional copy of the cry1Ab coding sequence was integrated into the corn genome and that coding sequence is inherited in the expected Mendelian pattern. The Cry1Ab protein shows no amino acid sequence homology to known protein toxins, and is rapidly degraded with loss of insecticidal activity under mammalian digestion condition. There were no toxicity indications during administration of Cry1Ab oral gavage. The cry1Ab gene was not derived from an allergenic source. The protein does not have immunologically relevant sequence similarity with known allergens or possess characteristics of known protein allergens. It was also reported to have no harmful effects on other types of organisms. Compositional analyses were performed. The compositional values of MON810 corn were compared with that of the control line, as well as published literature values. Compositional data confirmed that MON 810 corn is substantially equivalent to the parental hybrid as well as traditional corn hybrids. It was also confirmed that MON 810 corn plants are as safe and nutritious as conventional corn varieties. A comprehensive phenotypic, agronomic, environmental interaction assessment was conducted which included the evaluation of characteristics for seed germination, disease and pest susceptibilities and yield characteristics. Results indicate that MON 810 does not possess weediness potential, increased susceptibility or tolerance to specific abiotic stresses, diseases, or arthropods, or characteristics that would confer a plant pest risk compared to conventional corn. |
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| Authorization expiration date (a blank field means there is no expiration date) |
February 22, 2023 |
E-mail:
Organization/agency name (Full name): Bureau of Plant Industry
Contact person name: Geronima P. Eusebio
Website:
Physical full address: San Andres St., Malate, Manila
Phone number: 632 404 0409 loc 203
Fax number:
Country introduction: In 1987, scientists from the University of the Philippines Los Banos (UPLB) and the International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI), and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD), recognizing the potential harm of the introduction of exotic species and genetic engineering, formed a committee and formulated the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. The committee went on to draft a Philippine biosafety policy, which was submitted to the Office of the President. On October 15, 1990, recognizing the potential for modern biotechnology both in improving the lives of the people and in creating hazards if not handled properly, President Corazon C. Aquino issued Executive Order 430 creating the National Committee on Biosafety of the Philippines (NCBP) that will formulate, review and amend national policy on biosafety and formulate guidelines on the conduct of activities on genetic engineering. The NCBP is comprised of representative of the Departments of Agriculture (DA); Environment and Natural Resources (DENR); Health (DOH); and Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science; and 2 respected members of the community. On July 16, 2001, President Gloria Macapagal-Arroyo issued the Policy Statement on Modern Biotechnology, reiterating the government policy on promoting the safe and responsible use of modern biotechnology. On April 3, 2002, Department of Agriculture Administrative Order No. 8, Series of 2002 was issued implementing the guidelines for importation and release into the environment of Plants and Plant Products Derived from the Use of Modern Biotechnology. On March 17, 2006, President Gloria Macapagal-Arroyo issued Executive Order No.514 Establishing the National Biosafety Framework, prescribing guidelines for its implementation, reorganizing the National Committee on Biosafety of the Philippines, and for other purposes. On December 8, 2015, the Philippine Supreme Court declared DA AO8 null and void and any application for contained use, field testing, propagation and commercialization, and importation of GMOs was temporarily enjoined. In response to the nullification of DA AO8, the Technical Working Group composed of representatives from the Departments of Agriculture (DA), Science and Technology (DOST), Environment and Natural Resources (DENR), Health (DOH), and Interior and Local Government (DILG) drafted the Joint Department Circular No. 1, Series of 2016 (JDC No.1, S2016) titled 'Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically-Modified Plant and Plant Products Derived from the Use of Modern Biotechnology'. There were series of meeting and five public consultations conducted before the JDC No.1, S2016 was approved and signed by the Secretaries of the abovementioned agencies on March 7, 2016 and took effect on April 15, 2016. Under this Circular, more government agencies were involved such as the Department of Science and Technology (DOST) to regulate applications for contained use and confined test of regulated articles; Department of Agriculture (DA) to evaluate applications for field trial, commercial propagation and transboundary movement of regulated articles; Department of Environment and Natural Resources (DENR) to evaluate environmental risks and impacts of regulated articles; Department of Health (DOH) to evaluate of environmental health impacts of regulated articles; and Department of the Interior and Local Government (DILG) to supervise public consultation during field trial.
Useful links
Relevant documents
Stacked events: Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.
Plant Products Carrying Stacked Genes Conferred Through (a) Genetic Engineering or b) Conventional Breeding, with Individual Traits That Have No Prior Approval:
A full risk assessnent as to food and feed or processing shall be conducted,consistent with Part V of AO No. 8,"Approval Process For the Importation of Regulated Articles for Direct Use as Food and Feed or For Processing for plant products with multiple traits conferred through:
(a) genetic engineering, or
(b) conventional breeding, where the individual traits have no prior approval from the Bureau of Plant Industry (BPI) for direct use as food and feed or processing.
Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:
For plant products with multiple traits conferred through conventional breeding,with all individual events granted prior approval and included in the Approval Registry, a notlfication shall be submitted by the technology developer to the BPI, which shall conduct an evaluation in accordance with the relevant criteria in Annex I of this Memorandum Circular. The list of data contained in Annex I will not preclude the inclusion of other issues and concerns that will be raised by the BPI and the Scientific and Technical Review Panel (STRP) during the course of the desktop review.
Notificatlon Requirement for Plant Products Carrying Stacked Genes
All technology developers shall submit a notification to the Bureau of Plant Industry of their developed plant products carrying stacked genes and shall be required to comply with the relevant approval process listed above.
The Bureau of Plant Industry shall issue a certiflcate as to the approval of the stacked gene product and shall likewise include the transformation event in the official approval registry of plant products for food and feed or processing. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004
| Name of product applicant: |
Monsanto Korea Ltd. |
| Summary of application: |
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| Date of authorization: |
29/06/2002 |
| 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.): |
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| Summary of the safety assessment (food safety): |
Please to see 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: |
Monsanto |
| Summary of application: |
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| Date of authorization: |
21/09/2011 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
Corn line MON 810 (MON-00810-6) was generated by the transfer of the cry1A(b) gene (from Bacillus thuringiensis) into the parental line (genotype Hi-II) and confers protection against attack from insects. The protein product Cry1A(b) is an insecticidal crystal protein, whose toxic effect is specific to Lepidopteran insects, in this case the European Corn Borer. No other genes were transferred to the corn plant. The introduced gene for cry1A(b) was found to be stably integrated into the corn plant genome and is genetically stable over multiple generations. The new protein Cry1A(b) expressed in insect protected corn is non-toxic and unlikely to have allergenic effects. Compositional analyses demonstrate no significant differences between insect-protected corn and its conventional counterparts. Corn line MON 810 is regarded as equivalent to food derived from conventional corn. |
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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| Authorization expiration date (a blank field means there is no expiration date) |
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E-mail:
Organization/agency name (Full name): 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: |
MONSANTO THAILAND CO., LTD. |
| 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 MON810 is substantially equivalent to its conventional counterpart in terms of morphology, nutrition, toxicity and allergenicity. |
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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): National Burequ of Agricultural Commodity and Food
Contact person name: Director of Office of Standard Development
Website:
Physical full address: 50 Phahonyothin Rd., Lardyao, Chathuchak, Bangkok 10900
Phone number: +6625612277 ext.1401
Fax number: +6625613373
Country introduction: National Bureau of Agricultural Commodity and Food Standards (ACFS) is a governmental agency under the Ministry of Agriculture and Cooperatives (MOAC) responsible for the development of national agricultural and food standards. The Agricultural Standards Act B.E. 2551 (2008) establishes the mechanisms for the development of Thai Agricultural Standards (TAS) as either voluntary or mandatory standards. This is based on scientific data, consumer’s health and fair trade. Within the TAS, there are four standards relating GM food assessment, namely Principle for the Risk Analysis of Foods Derived from Biotechnology (TAS 9010-2006), Assessment of Possible Allergenicity (TAS 9011-2006), Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (TAS 9012-2006) and Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms (TAS 9013-2006). These standards are adapted from relevant Codex standards. Safety assessment for imported GM crops and foods is done by the cooperation of the Food and Drug Administration (FDA) and the National Center for Genetic Engineering and Biotechnology (BIOTEC)via the Committees relating National Committees to consider technical and political issues. The Committees comprise representatives from all relevant governmental and non-governmental key sectors including experts on genetic modification, toxicity and others.
The safety assessment process of GM food in Thailand is on a voluntary basis. According to the current laws and regulations, there is no approval authority. Useful links
Relevant documents
Stacked events: The safety assessment for stacked events is divided into two patterns. The first pattern is for stacked events whose GM parents have never approved by FDA or other competent authority. Those stacked events shall be fully assessed in line with GM foods. Another pattern is introduced for the safety assessment of stacked event lines where from GM parents had already been approved. In the second pattern, the information of the parents could be used for consideration, as appropriate. However, the information relevant to interaction between genes and new proteins of stacked event should be mainly taken into account. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Food and Drug Administration (FDA) and National Center for Genetic Engineering and Biotechnology (BIOTEC)
| Name of product applicant: |
MONSANTO THAILAND CO., LTD. |
| 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 MON810 is substantially equivalent to its conventional counterpart in terms of morphology, nutrition, toxicity and allergenicity. |
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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| Authorization expiration date (a blank field means there is no expiration date) |
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E-mail:
Organization/agency name (Full name): National Burequ of Agricultural Commodity and Food
Contact person name: Director of Office of Standard Development
Website:
Physical full address: 50 Phahonyothin Rd., Lardyao, Chathuchak, Bangkok 10900
Phone number: +6625612277 ext.1401
Fax number: +6625613373
Country introduction: National Bureau of Agricultural Commodity and Food Standards (ACFS) is a governmental agency under the Ministry of Agriculture and Cooperatives (MOAC) responsible for the development of national agricultural and food standards. The Agricultural Standards Act B.E. 2551 (2008) establishes the mechanisms for the development of Thai Agricultural Standards (TAS) as either voluntary or mandatory standards. This is based on scientific data, consumer’s health and fair trade. Within the TAS, there are four standards relating GM food assessment, namely Principle for the Risk Analysis of Foods Derived from Biotechnology (TAS 9010-2006), Assessment of Possible Allergenicity (TAS 9011-2006), Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (TAS 9012-2006) and Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms (TAS 9013-2006). These standards are adapted from relevant Codex standards. Safety assessment for imported GM crops and foods is done by the cooperation of the Food and Drug Administration (FDA) and the National Center for Genetic Engineering and Biotechnology (BIOTEC)via the Committees relating National Committees to consider technical and political issues. The Committees comprise representatives from all relevant governmental and non-governmental key sectors including experts on genetic modification, toxicity and others.
The safety assessment process of GM food in Thailand is on a voluntary basis. According to the current laws and regulations, there is no approval authority. Useful links
Relevant documents
Stacked events: The safety assessment for stacked events is divided into two patterns. The first pattern is for stacked events whose GM parents have never approved by FDA or other competent authority. Those stacked events shall be fully assessed in line with GM foods. Another pattern is introduced for the safety assessment of stacked event lines where from GM parents had already been approved. In the second pattern, the information of the parents could be used for consideration, as appropriate. However, the information relevant to interaction between genes and new proteins of stacked event should be mainly taken into account. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Food and Drug Administration (FDA) and National Center for Genetic Engineering and Biotechnology (BIOTEC)
| Name of product applicant: |
Special case: please show below |
| Summary of application: |
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| Date of authorization: |
21/04/2012 |
| 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 and also by considering public opinion,
Biosafety Board has approved the use of genetically modified maize MON810 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: |
Monsanto Company |
| Summary of application: |
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| Date of authorization: |
19/12/1996 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
Please see EPA BRAD and FDA consultation. |
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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: |
EPA BRAD
FDA Consultation
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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: |
Monsanto Co. |
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| Date of authorization: |
20/06/2003 |
| 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.): |
BCH
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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: |
GNBio
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E-mail:
Organization/agency name (Full name): Ministerio de Ganadería, Agricultura y Pesca
Contact person name: Alejandra Ferenczi
Website:
Physical full address: Constituyente 1476, Piso 2, Of. 212B. Montevideo, Uruguay
Phone number: +598 2 4104155 int 3
Fax number:
Country introduction: The Uruguayan National Biosafety System (SNB for its acronym in Spanish) includes safety assessments of food end feed, environmental risk assessment, risk management, and risk communication. The National Biosafety Cabinet (GNBio) is the competent authority on biosafety of GMOs. Integrated by: The Minister of Agriculture, MGAP (chair); Minister of Health (MSP); Minister of Economy (MEF); Minister of Environment (MVOTMA); Minister of Foreign Affairs (MRREE); and Minister of Industry (MIEM). This Cabinet is the last responsible to make decisions over a submitted request. It has the authority to define policies to be followed with respect to biosafety in all scopes of GMO application. Other committees of experts and scientists give support to decisions of GNBio through risk analysis of biotechnological products. The Risk Management Commission (CGR) is composed by one delegate of each of the ministries represented within GNBio. The CGR advises GNBio on GMO biosecurity issues; elaborates reference terms for risk assessments; manages the risk communication participation process; is responsible for follow-up and monitoring of authorized events. The Risk Assessment in Biosecurity (ERB) is composed of experts proposed by the CGR and designated by GNBio among specialists in the different areas of risk assessment. Is responsible for considering, on a case-by-case basis, the potential risks and benefits of each new biotech product; assure case-by-case risk assessment evaluation based on scientific methods; writes an operational plan (pre-report) of risk assessment according to CGR directives; advises CGR based on the results of the analysis of risk assessment, and provides information during the consultation process. The Institutional Articulation Committee (CAI) is a committee of technical experts from nine different national public and research institutions, which analyzes the risk assessment of new events and prepares a technical report. The technical analysis is coordinated by ERB organized in different ad hoc groups of experts. The Ad hoc experts groups are technical-scientific specialists in different areas of knowledge related to the analysis of GMO events like characterization and molecular identification of events, environmental and food safety aspects. Useful links
Relevant documents
Stacked events: GM vegetables from cross-pollinated species, such as corn, with stacked events are not considered as a new product. In the case of GM vegetables from self-pollinated species, such as soybean, are considered as a new product even if all single events stacked have already been approved. However, there is an abbreviated analysis procedure in cases where single events were already analyzed. Stacked events not yet analyzed must have the individual risk assessment report. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: GNBio office. E-mail: [email protected]; Adress: Constituyente 1476, piso 2, oficina 212B, Montevideo 11200, Uruguay.
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MON 810 |
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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): |
The data and information in safety assessment support the conclusion that the foods and feeds derived from MON 810 are expected to be as safe and nutritious as the comparable foods and feeds derived from conventional corn. This conclusion is based on several lines of evidence including:
1) The detailed molecular characterization of the inserted DNA, which confirmed the presence of an intact cry1Ab gene cassette stably integrated at a single locus of the corn genome,
2) The history of safe use and the biochemical characterization of the Cry1Ab protein produced in MON 810,
3) A safety assessment of the Cry1Ab protein, which shows the lack of acute toxicity and allergenic potential,
4) Compositional and nutritional assessments demonstrating that MON 810 is equivalent in composition to conventional corn. |
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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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