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OECD Unique Identifier details

MON-ØØ6Ø3-6
Commodity: Corn / Maize
Traits: Glyphosate tolerance
European Union
Name of product applicant: Monsanto Europe S.A.
Summary of application:

Genetically modified maize line NK 603 expresses the CP4 EPSPS protein which confers tolerance to the glyphosate herbicides.


Products:


1.) Foods and food ingredients containing, consisting of, or produced from MON-ØØ6Ø3-6 maize
2.) Feed containing, consisting or produced from MON-ØØ6Ø3-6 maize
3.) Products other than food and feed containing or consisting of MON-ØØ6Ø3-6 maize for the same uses as any other maize with the exception of cultivation

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Date of authorization: 24/04/2015
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): EU Register of authorised GMOs
Summary of the safety assessment (food safety):
Please see the EU relevant links below.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Method for detection: Event specific real-time quantitative PCR based method for genetically modified NK 603 maize Validated by the Joint Research Centre (JRC) of the European Commission, in collaboration with the European Network of GMO Laboratories (ENGL). Reference material: ERM®-BF415 accessible via the Joint Research Centre (JRC) of the European Commission, Institute for Reference Materials and Measurements (IRMM). Relevant links are provided below.
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Opinion of the European Food Safety Authority
Method for detection
Reference material
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Authorization expiration date (a blank field means there is no expiration date) 26/04/2025
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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).

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Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Australia
Name of product applicant: Monsanto Australia Ltd
Summary of application:
Glyphosate is the active ingredient of the proprietary herbicide Roundup® which is used widely as a non-selective agent for controlling weeds in primary crops. The corn is known commercially as Roundup Ready (RR) corn line NK603.

Glyphosate directly affects the shikimate biosynthetic pathway in plants. The mode of action of glyphosate is to specifically bind to and block the activity of 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS), an essential enzyme involved in the biosynthesis of aromatic amino acids in all plants, bacteria and fungi. Blocking the enzyme results in the breakdown of the synthesis of essential aromatic amino acids in cells, ultimately leading to the death of the plant.

Biochemical studies on the EPSPS enzyme from a variety of different species have shown that a natural variation in glyphosate binding affinity exists, particularly across bacterial species (Schultz et al. 1985). Tolerance to glyphosate in plants can therefore be achieved by introducing a bacterial version of the EPSPS gene producing a protein with a reduced binding affinity for glyphosate, thus allowing the plant to function normally in the presence of the herbicide.

In glyphosate-tolerant corn line NK603, the herbicide-tolerance trait is generated in the plants through the addition of a bacterial EPSPS gene derived from a common soil bacterium, Agrobacterium sp. strain CP4 (CP4 EPSPS). The enzyme produced from the introduced gene has a reduced affinity for the herbicide compared with the corn enzyme, and thus imparts glyphosate tolerance to the whole plant.

The bacterial CP4 EPSPS is used also in Roundup Ready varieties of soybean, canola,
sugar beet and cotton. Foods derived from these modified crop lines have previously been assessed for safety by ANZFA and have been approved5 for food use in Australia and New Zealand under Standard A18 – Food Produced Using Gene Technology in Volume 1(Standard 1.5.2 in Volume 2) of the Food Standards Code.

Corn is used predominantly as an ingredient in the manufacture of breakfast cereals, baking products, extruded confectionery and corn chips. Maize starch is used extensively by the food industry for the manufacture of many processed foods including dessert mixes and canned foods.

Despite the diverse uses of corn products in many foods, corn is a relatively minor crop in both Australia and New Zealand, with a declining area planted over the last decade. Consequently, there is a requirement to import products such as high-fructose corn syrup and maize starch to meet manufacturing demand. The glyphosate-tolerance trait has not been introduced into sweet corn or popcorn varieties and therefore the whole kernel from corn line NK603 is not consumed directly as food, but rather is processed into various corn fractions.
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Date of authorization: 20/06/2002
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.): OECD BioTrack Product Database
Summary of the safety assessment (food safety):
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Application A416 - To amend Standard A18 - Food produced using Gene Technology - Glyphosate-Tolerant Corn Line NK603
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Website:
Physical full address:
Level 4, 15 Lancaster Place, Majura Park ACT 2609, Australia
Phone number:
+61 2 6271 2222
Fax number:
+61 2 6271 2278
Country introduction:

Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 115 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 10 staff) is located in Wellington on the North Island.

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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)

Brazil
Name of product applicant: Monsanto do Brasil Ltda.
Summary of application:
commercial release of genetically modified glyphosate tolerant corn Roundup Ready 2 Event NK603
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Date of authorization: 18/09/2008
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.): Center for Environmental Risk Assessment
Summary of the safety assessment (food safety):
NK603 corn expresses glyphosate protein CP4 5-Enol-pyruvylshikimate-3-phosphate synthase (CP4 EPSPS). Weed control performed by glyphosate is due to inhibition of EPSPS enzyme naturally produced by the plant. The enzyme catalyzes a critical phase of the metabolic way of shikimic acid for biosynthesis of aromatic amino acids in plants and microorganisms. CP4 EPSPS proteins have low glyphosate affinity, when compared with the wild EPSPS protein. Therefore, when the NK603 corn expressing protein CP4 EPSPS is treated with glyphosate, the plants keep developing normally. The continuous action of glyphosate tolerant CP4 EPSPS enzyme catalyzes the synthesis of amino acids required for the normal development of the plant. The biosynthetic way of aromatic amino acids is not found in animals, which explains the glyphosate selective activity in plants and contributes towards low toxicity to mammals. Two cp4 epsps gene expression cassettes were introducing in the corn genome through a single insert, producing NK603 corn. The cp4 epsps gene is derived from a bacterium common in the soil, Agrobacterium sp. strain CP4, which codifies the expression of protein EPSPS naturally tolerant to glyphosate. The gene donor organism, A. tumefaciens strain CP4 is a bacterium commonly found in the soil and causes galls in susceptible plants, with no scientific evidence indicating that it may cause adverse effects to humans or animals. Toxicity tests were conducted with EPSPS-synthase enzyme isolated from transformed plants. Ingestion through gastric gavage of the protein molecule in doses 1000 times above the figure for modified seeds failed to cause any physiologic change in animals tested. Results of in vitro proteolysis also verified rapid digestion and innocuousness of the engineered protein, removing any suspicions of allergenicity. CP4 EPSPS protein is atoxic, as demonstrated by a oral acute toxicity stud, when CP4 EPSPS was administered to mice in one single high dose. The protein, produced and purified from Escherichia coli, was characterized and showed to be equivalent to the CP4 EPSPS produced in the corn. The purified protein was orally administered to mice for assessing its acute toxicity. Acute administration was deemed as appropriate in assessing the safety of CP4 EPSPS, since toxic proteins act by means of acute mechanisms. The no-observed-effect-level (NOEL) for oral toxicity in mice was 572 mg/kg, the highest tested dose. The result represented a safety margin of about 260,000 times, based on the average daily consumption of corn in the United States and average expression of the protein in the glyphosate tolerant genetically modified corn (assuming that there is no loss of CP4 EPSPS throughout processing). There were no statistically different differences in body weight, aggregate body weight or food consumption between control groups (with the vehicle or bovine albumin serum) and groups treated with the purified CP4 EPSPS protein. EPSPS proteins are ubiquitous in nature and are naturally present in foods derived from plant and microbial sources and do not show significant homology of amino acids with proteins known to be toxic or allergenic to mammals. Apparently, the CP4 EPSPS protein was rapidly digested by in vitro gastric and bowel fluids. Besides, EPSPS proteins that have a history of safe use are widely used in the diet, corn is a plant unable to survive in natural conditions, without technical assistance. Therefore there is no possibility that the corn shall be transformed in an invading plant or pest. Even in case of un unlikely genic escape, the possibility of fixation of an allele containing the genic sequence that grants tolerance to glyphosinate in the population is very reduced in the absence of selective pressure. The NK603 corn demonstrated to be equivalent to conventional corn, with the exception of its tolerance to glyphosate. Its basic interactions with other living organisms in the environment are not deemed to be different from the ones of conventional corn. Though there is a potential exposure of weed, pests and pathogens of corn culture to the CP4 EPSPS and CP4 EPSPS L214P proteins that are expressed in the NK603 corn, there are no concerns that the process may negatively affect such populations. Through trophic transfer and decomposition processes, organisms that are not targets to CP4 EPSPS and CP4 EPSPS L324P proteins, such as predators and preys of corn pests, may be exposed to very low levels of such proteins without, however, emerging any evidence of negative effects on the non-target organisms. Environment safety of the EPSPS protein family is widely accepted, since the proteins are ubiquitous in nature (bacteria, fungi, algae and higher plants), do not have known toxicity, are not associated to pathogenicity and fail to grant any selective advantage to plants that contain the proteins. For the foregoing, there are no restrictions to the use of the genetically modified corn and its derivatives, either as human of animal food. In addition, the proteins stem from the EPSPS protein family, with a long history of safe consumption and exposure, occurring ubiquitously in plants and microorganisms. Analytic studies comparing the composition of kernel and forage of NK603 with the conventional corn show that the genetically modified glyphosate tolerant NK603 corn is substantially equivalent to conventional corn. Based on studies conducted during the several years of marketing NK603 corn and other glyphosate tolerant cultures expressing the CP4 EPSPS protein, coupled with the safe history of the corn as a consumption source for human and animal food, one reaches the conclusion that glyphosate tolerant NK603 corn, or Roundup Ready 2 corn is substantially equivalent and as safe as conventional corn. Coexistence of cultivars of conventional (either improved or wild) corn and cultivars of transgenic corn is possible from the agronomic viewpoint and shall comply with the provisions of CTNBio Ruling Directive no. 4. According to Article 1 of Law no. 11,460, of March 21, 2007 ”research and cultivation of genetically modified organisms may not be conducted in Amerindian areas and conservation units”. Regarding the scope of Article 14 of Law no. 11,105/05, CTNBio holds that the request complies with applicable legislation and regulation aimed at securing biosafety of the environment, agriculture, human and animal health. CTNBio Technical Opinion 1. GMO Identification GMO name: Roundup Ready 2 Corn – Event NK603 Applicant: Monsanto do Brasil Ltda. Species: Zea mays – Corn Inserted Feature: Glyphosate herbicide tolerance Insertion method: Biobalistics (particle acceleration) method Prospective use: Production of silage and kernel for human and animal consumption from the GMO and its derivatives II. General Information Zea mays L., corn, is a species of the Maydae tribe, included in the subfamily Panicoidae, family Graminea (Poacea). Genera belonging to the Maydae tribe include Zea and Tripsacum in the Western Hemisphere. Corn is a separate species within the Zea subgenus, with a chromosome number 2n = 20,21,22,24(9). The wild species closest to corn is teosinte, found in Mexico and some other places of Central America, where it may cross with cultivated corn in production fields. Cultivated corn may also cross with a more distant genus, the Tripsacum. The crossing seldom happens and results in a sterile male progeny. Corn has a history of eight thousand years in the Americas. Out of all cultivated plants, corn is probably the one possessing the largest genetic variability. Today, about three hundred races of corn are identified and, within each such race, there are thousands of cultivars. Corn is currently the cultivated species that reached the highest degree of domestication and it may only survive in nature when raised by man(4). Normally, the maintenance of this genetic variability has been achieved through individualized storage, in germplasm banks, under controlled humidity and temperature. There are several germplasm banks, in Brazil and all over the world. Embrapa, the Brazilian Agricultural Research Agency, has two germplasm banks, one at Embrapa Recursos Genéticos e Biotecnologia, Embrapa Genetic Resources and Biotechnology, in Brasília, Federal District, Brazil, and another at Embrapa Milho e Sorgo, Embrapa Maize and Sorghum, in Sete Lagoas, Brazil. Corn is farmed in over 100 countries, with a total estimated production of 705 million tons per year. Corn is one of the most important food sources in the world and is the raw material for a large range of products. From 70% to 80% of corn produced in Brazil is consumed by the swine and poultry productive chain. Brazil is the world third largest corn producer, with an output of about 35 million tons in 2005, behind the United States of America (282 million tons) and China (139 million tons)(11).In Brazil, corn is planted basically in two different crops (summer and safrinha, or small crop) and is cultivated in practically all the domestic territory, with 92% concentrated in the Southern Region (47% of production), Southeastern Region (21% of production) and Center Western Region (24% of production)(8). Corn is one of the most efficient plants in converting solar energy in food and is used as raw material for several products. The increase in corn consumption exceeded 100 million tons between 1993 and 2001, representing an average yearly increase of 11.1 million tons per year. A large part of this increased production was due to genetic improvement, leading to ears containing about 1,000 seed-corns. Increased corn production and consumption all over the world is associated to its multiple uses, population growth, changes in feeding habits, and growth in the number of farmed swine and poultry. Brazil is the world third largest consumer of pesticides. The country has currently 142 pesticides registered for corn. There are several reports of resistance cases caused by the constant and indiscriminate use of herbicides in corn farming in Brazil. According to CUT(24) citing data from the World Health Organization (WHO), one million people are intoxicated each year by farm pesticides in Brazil. The Ministry of Health confirms that in sixteen Brazilian states, farm defensives are the largest cause affecting farmers’ health. The use of herbicide tolerant corn, such as NK603 corn, has given an opportunity for efficient management of pests and rotation of herbicide principles in corn farming(13). One impact recorded is the reduction of herbicide use in farming pre-emergence. Farmers have reduced the rates of pre-emergent herbicide applied to the soil and, through the use of wide spectrum herbicides, as glyphosate, have managed to control pests in an effective way. Replacement of several herbicides by a single herbicide with a wider spectrum has resulted in savings around $25/ha. Studies conducted in the United States with herbicide tolerant corn suggest positive economic yields with the single use of glyphosate or glyphosate associated to conventional herbicides in pre-emergence(25). The results establish that herbicide tolerant corn, including NK603, provides an increase in productivity while reducing herbicide costs(7). Glyphosate tolerant NK603 corn was released for the first time in the United States for farming and marketing in 2000, and is currently farmed, or has its consumption permitted, in twelve countries: Argentina, Australia, Canada, China, European Unit, Japan, Korea, Mexico, Philippines, South Africa, Taiwan and USA. NK603 corn expresses CP4 5-Enol-pyruvylshikimate-3-phosphate synthase (CP4 EPSPS) proteins that are glyphosate tolerant. CP4 EPSPS protein is one of several EPSPS proteins found in nature, which are produced by plants, bacteria and fungi, but not by animals, since those do not possess the metabolic way for its synthesis. Therefore, different versions of the EPSPS protein are normally present in all food derived from plants and microorganisms. The gene donor organism, Agrobacterium tumefaciens strain CP4, is a bacterium normally found in the soil. It causes galls in susceptible plants and there is no scientific evidence indicating that it may cause adverse effects in humans or animals. It is worth noticing that the history of farming, marketing, use and experience with other genetically modified cultures that express CP4 EPSPS protein since the first marketing of RR soy in 1994, has shown that the protein failed to display any risk to the environment, and to human and animal health. III. Description of the GMO and Proteins Expressed Gene cp4 epsps, which codifies a glyphosate tolerant form of the 5-Enol-pyruvylshikimate-3-phosphate synthase (EPSPS) was isolated from the bacterium Agrobacterium tumefaciens strain CP4 and inserted in corn through biobalistics (particle acceleration). The action of glyphosate, causing the death of plants, takes place due to its ability to block the activity of the target enzyme (EPSPS) belonging to the biosynthetic way of aromatic amino acids tyrosine, phenylalanine and tryptophan. Thus, plant cells that express protein CP4 EPSPS keep producing aromatic amino acids essential to their metabolism, even in the presence of glyphosate. Protein CP4 EPSPS is one of several EPSPS proteins found in nature, produced by plants, bacteria and fungi, but not by animals, which lack the metabolic way for the protein synthesis. Therefore, different versions of the EPSPS protein are normally present in all food derived from plants and microorganisms. The gene donor organism, Agrobacterium tumefaciens strain CP4, is a bacterium normally found in the soil that causes galls in susceptible plants and there is no scientific evidence indicating that it may cause adverse effects in humans or animals. NK603 corn was produced through genetic transformation of a LH82XB73 corn lineage using a DNA fragment of 6706 pairs of bases (pb) containing two adjoining cassettes of gene cp4 epsps to express the CP4 EPSPS protein. Each such cassettes, namely, the proximal cassette (closer to the 5’ end) and distal cassette (closer to the 3’ end) contained a single copy of the cp4 epsps gene and regulating sequences. In both cassettes, sequences of the cp4 epsps genes were linked to transit polypeptide sequences to chloroplast (CTP2) obtained from an epsps gene of Arabidopsis thaliana. The function of transit polypeptides is transporting the CP4 EPSPS protein to the chloroplasts where the metabolic way responsible for synthesizing aromatic amino acids operates. CTP4s are removed from protein CP4 EPSPS after its delivery at the chloroplast. In the proximal cassette, fragment ctp2-epsps was placed under the control of rice promoter actin1 and its intron and, in the distal cassette, placed under the control of CaMV 35S modified promoter (e35S). At the distal cassette, between promoter e35S and the CTP2 sequence, an intron of 0.8 kb, from a corn protein, was also introduced, involved in answers to thermal shocks (hsps70) with the purpose of increasing the levels of genetic transcription. In both cassettes, sequences cp4 epsps were connected to the sequence of 0.3 kb of nopaline synthase 3’ (not translated) named NOS 3’, with the purpose of providing a sign for polyadenylation of the messenger RNA (mRNA). The DNA fragment of 6706 pb was used in the genetic transformation was isolated from plasmid PV-ZMGT32L as a single fragment through digestion with a restriction enzyme MIuI and separation in electrophoresis gel. Therefore, this fragment did not contain other plasmid elements as origin of plasmid replication and the sequence of gene npt II codifying the neomycin transferase type II enzyme. This enzyme grants resistance to aminoglycoside antibiotics such as kanamicyn and neomycin used to select the bacteria during the construct and multiplication of the plasmid. Transformed cells were selected in tissue culture in the presence of glyphosate. The DNA fragment was characterized using analyses of Southern Blot, a Polymerase Chain Reaction (PCR) technique, and sequencing of the inserted fragment and its bordering regions in the transformed corn genome. Results showed that the NK603 corn genome contains a single exogenous DNA insertion and that no DNA of the plasmid replication structure had been detected in the NK603 corn genome. Inside the single insert, a complete copy of the 6706 pb DNA fragment used in the transformation was found and one 217 pb fragment in the region of the actin promoter that fails to contain the necessary elements to act as a promoter. Both the proximal and distal cassettes of the cp4 epsps gene are present in the single insert and their genetic components are intact. In the distal cassette, the cp4 epsps gene nucleotide sequence differs from the original sequence used in the process of transformation in two nucleotides. One nucleotide change was silent while the other resulted in the substitution of an amino acid in position 214. The changed nucleotide in position 214 pb resulted in the coding of a leucine instead of a proline. This new sequence came to be called cp4 epsps L214p. Analyses of PCR products of terminal 3’ of the inserted DNA revealed the co-integration of a 305 pb additional DNA fragment of a chloroplast DNA. Results of computational biology showed that the co-integrated DNA corresponds to a part of DNA sequences codifying the alpha subunit of RNA polymerase and the ribosome protein S11. It is believed that the origin of this DNA is the chloroplast of the transformed cell. Proteins CP4 EPSPS and CP4 EPSPS L214P are present in small concentrations in seeds and forage of NK603 corn since rice actin promoters and e35s act in a constitutive way. Studies show that there is equivalence of both with proteins produced in Escherichia coli containing plasmid of heterologous expression possessing homology with EPSPS proteins that are naturally produced by plants and microorganisms used in human and animal food. Regarding nutritional and environmental safety, both the EPSPS proteins naturally present in non-transgenic plants and microorganisms and the CP4 EPSPS proteins expressed in glyphosate tolerant genetically modified cultures belong to a family of proteins known for their absence of toxicity, non association to pathogenicity events and failure to grant any selective advantage to plants or microorganisms containing them. Although primary amino acid sequences in different members of the EPSPS protein family show considerable divergence, the expressed proteins are highly related in terms of structure and function. IV. Aspects related to Human and Animal Health Security assessment of food derived from genetically modified raw-materials is based on risk analysis, a scientific methodology that encompasses the phases of risk assessment, risk management and risk communication. In the risk assessment, one pursues the qualitative and quantitative characterization of potential adverse effects, based on the concept of substantial equivalence to identify any differences between the new food and its conventional correspondent. Assessing the security of a genetically modified food raw-material, or its equivalence to conventional food, it is recommended that four elements are analyzed, namely: (1) Parental variety, i.e. the plant originating the new genetically modified raw-material; (2) Transformation process, including a characterization of the construct used and the resulting event; (3) Product of the inserted gene and potential toxicity and allergenicity and, finally; (4) Composition of the new variety resulting from genetic transformation. The data set of such analyses shall enable identifying and characterizing any potential adverse effect associated with consumption of the new raw-material, providing information to the risk management and risk communication phases. Changes to NK603 corn were caused by introducing the gene cp4 epsps, granting tolerance to the presence of the herbicide glyphosate in the pos-emergence phase of the plant. The engineered gene of the EPSPS synthase is the most studied transformation in plants, mainly soy and corn, with a large technical and scientific bibliography covering different aspects resulting from such transformation. The organism donor of gene cp4 epsps was the soil bacterium Agrobacterium sp., CP4strain. This organism donor of the gen inserted in NK603 corn is not used in the production of, nor used as, food. Besides, Agrobacteria species are non pathogenic to humans and animals and there are not reports that the epsps gene may be a determinant of the pathogenicity associated with Agrobacterium in plants. The EPSPS proteins catalyze the conversion of shikimic acid into 5-Enol-pyruvylshikimate-3-phosphate, which is an intermediary in the synthesis of aromatic amino acids and phenolic compounds. For their functions, EPSPS are essential to normal growth of plants and microorganisms. There is no toxicity associated to this family of proteins, which has a long history of environmental and nutritional safety. Besides, EPSPS proteins are not known for their persistence in the environment nor for affecting the phenotype of the host organisms with negative properties, such as pathogenicity or potentially development into pests. Several researchers conducted comprehensive characterizations of the CP4 EPSPS protein and the results showed that this protein has enzymatic properties equivalent to the EPSPS proteins endogenous to plants and microorganisms(14). In addition, detailed studies showed that the CP4 EPSPS protein is susceptive to proteolysis and enzymatic digestion, as it would be expected for an EPSPS protein. Besides, the data available from acute oral toxicity studies, in vitro digestibility and bioinformatics comparison of CP4 EPSPS confirm its equivalence to EPSPS proteins. Toxicity tests were conducted with EPSPS-synthase isolated from transformed plants. Harrison et. al.(14) showed by means of ingestion by gastric gavage that protein molecule doses over one thousand times the one found in modified seeds fail to cause cause physiologic alterations in essayed animals. Results from in vitro proteolysis also confirm the prompt digestion and innocuousness of the engineered protein, removing any suspiciousness of allergenicity(14). In addition to the history of safe use of the EPSPS class proteins, studies were conducted that ratify the security of CP4 EPSPS proteins expressed in cultures such as soy, cotton, corn, canola and sugar beet. In one acute oral toxicity study, CP4 EPSPS was administered to mice, in one high dose, to confirm its safety(14). The results of such study showed that, as expected, the CP4 EPSPS protein is not toxic. The CP4 EPSPS protein was produced and purified from E. coli, was characterized and showed to be equivalent to the CP4 EPSPS produced in corn. The purified protein was orally administered to mice for acute toxicity assessment. Acute administration was deemed proper to assess the security of CP4 EPSPS, since toxic proteins act through acute mechanisms(23,18). The NOEL no observable effect for oral toxicity in mice was 572 mg/kg, the highest tested dose(12). The result represented a security margin of about two hundred and sixty thousand (260,000) times, based on the average daily consumption of corn in the United States and expression of the protein in the glyphosate tolerant genetically modified corn (assuming that there is no loss of CP4 EPSPS during processing). No statistically significant differences were observed in body weight, aggregate body weight or consumption of food among control groups (with the vehicle or bovine albumin serum) and groups treated with the purified CP4 EPSPS protein. This is an expected result, since most EPSPS proteins are atoxic. The CP4 EPSPS protein showed to be promptly digested in the gastric and bowel fluids in vitro. Besides, EPSPS proteins have a safe history of use, since they are present common diet. Dairy cows were fed with forage and with glyphosate tolerant genetically modified corn, while milk production and composition was assessed in comparison with the cows receiving the conventional plant(15). The results of this experiment indicate that there was no significant differences stemming from the food source, either in composition or yield of the milk produced by the animals. Sheep fed with glyphosate tolerant canola were assessed regarding digestibility and permanence time of the recombinant DNA in the gastrointestinal tract. The cp4 epsps gene and its fragments were monitored by PCR in real time and by conventional amplification of intestinal fluids incubated at 39ºC during periods of time from zero to 240 minutes. Results showed that genes present in fodder remained whole for a period relatively short, reducing the likelihood of its absorption by the animal, and indicate also that intestinal microorganisms are responsible for the rapid degradation of DNA at a pH 7(2). One long term study was conducted in salmons, with diets based on soybeans and corn modified with the cp4 epsps gene(22). Upon completion of the essays, the authors verified that there were no significant changes in corporeal development, pyloric cecum and middle intestine of the fish during the eight months of the experiment. CP4 EPSPS proteins are ubiquitous in nature and are naturally present in foods derived from plant and microbial sources. The proteins do not show significant homology of amino acids with proteins known to be toxic or allergenic to mammals. Besides, the CP4 EPSPS protein was rapidly digested by in vitro gastric and bowel fluids. Further, EPSPS proteins have a history of safe use and are widely present in our diet. Comparative allergenicity tests in sensibilized patients were conducted with conventional soybean and corn, genetically modified and the respective isolated heterolog proteins(5). Products tested proved to be safe regarding their allergenic potential, since there was no change in reactivity levels for modified kernel and the isolated proteins failed to cause any reaction in sensibilized individuals. Corn is not in the group of eight foods (milk, wheat, eggs, fish, crustaceans, peanuts, soybean and nuts) that answer for about 90% of allergies in humans. Allergy to corn may occur by ingestion of corn and its derivatives or through inhalation of its flour or pollen. Corn has a long history in human and animal feeding, with rare cases of harm caused to health. According to Metcalfe (2003), allergy cases reported in this plant species are not common, though recent studies show that previous diagnose methods may have underestimated the cases(21). Several very consistent scientific studies proved that the nutritional value of NK603 Corn, or Roundup Ready Corn is, on average, equal to that of conventional corn. We emphasize “on average” because both corn types record variations (deviations from average), and this variation was shown to be similar in both cases. Given the specific characteristics of the NK603 corn production process, one may foresee that, when cultivated under specific agronomic conditions (e.g., high competition with invading plants), the nutritional value of corn derived from such GMO is likely to be, in fact, higher than the conventional corn. V. Environmental Aspects Corn is a monoecious plant: a single individual has separately located male and female flowers. Corn plants are crossed fecundation plants and largely pollinated with the help of wind, insects, gravity and others. Introduction of the genic elements mentioned above did not change the reproductive characteristics of the plant. Therefore, the likelihood of crossed fecundation between hybrids and lineages of non genetically modified corn, and between plants of the NK603 event and other corn plants are the same. Corn is the species that reached the highest domestication level among cultivated plants, and has lost its ability to survive in nature such as, for instance, elimination of threshing. Thus, corn is a plant unable to survive in natural conditions, without technical assistance. Therefore there is no possibility that corn changes into an invading plant or pest. Genic flow in corn may take place through pollen transfer and through seed dispersion. Seed dispersion is easily controlled, since corn domestication eliminated the mechanisms for seed dispersion of the plant ancestors and the pollen movement is the only effective way for corn plant genes to escape. Studies on corn pollen dispersion have been conducted, and some show that corn pollen may cover long distances. However, the majority of the released pollen is deposited close to the culture, with a very low translocation rate outside the source culture. The main corn pollination agent is the wind and the distance that a viable pollen may cover depends on wind pattern, moistness and temperature. Luna et. al.(19) assessed the isolation distance and control of pollen, and showed that crossed pollination happens in a distance up to two hundred meters and no crossed pollination took place in distances exceeding three hundred meters from the pollen sources, when the corn ear still keeps the silk. Results indicate that pollen viability is kept for two hours and that crossed pollination was not observed in distances of three hundred meters from the pollen source. With low to moderate winds, estimates are that, comparing concentrations at 1m from the source culture, about 2% of pollen are recorded at 60m, 1.1% at 200m and 0,75-0,5% at 500m of distance. At 10m away from a field, on average, the number of pollen grains per unit of area is ten times lower than the figure recorded at 1m from the border. Therefore, if the established separation distances developed for production of corn seeds are observed, one expects that the transference of pollen to adjoining varieties is minimized, with no herbicide tolerant generic material. Even in case of a genic escape, the probability of allele fixation containing the genic sequence conferring tolerance to glyphosate in the population is very reduced in the absence of selection pressure. Cultivated corn is known for its interaction with different organisms in the environment, including microorganisms, wild animals and soil and aerial invertebrates. Besides, corn is known for its susceptibility to different fungi, viruses, bacteria, nematoids, pests caused by insects and acarine, use of pesticides and other agricultural practices, such as rotation of cultures and use of resistant or tolerant genotypes developed by classic improvement. Interaction of corn culture with wild vertebrates happen in large number and is well known, since corn is an excellent source of nutrition. Such interactions happen with birds and mammals that live or find shelter in the agricultural environment or close to this environment, in its borders, shrubs and dens. NK603 corn has shown to be equivalent to conventional corn, except for the glyphosate tolerant characteristic. Its basic interactions with other organisms in the environment are not held as different from interactions of conventional corn. Though there is the potential exposure of corn culture weeds, pests and pathogens to CP4 EPSPS and CP4 EPSPS L214P proteins that are expressed in NK603 corn, there are no concerns about the process causing adverse effects on such populations. Through trophic transference and decomposition process, organisms that are not targets of CP4 EPSPS and CP4 EPSPS L214P proteins, such as predators and preys of corn pests, may be exposed to very low levels of the proteins without evidence of negative effects on such organisms. Environment safety of the EPSPS protein family is well accepted, since the proteins are ubiquitous in nature (bacteria, fungi, algae and higher plants), have no known toxicity, association with pathogenicity and do not grant comparative selective advantage to plants that contain the proteins. Though EPSPS proteins are found in plants and microorganisms, primary amino acid sequences display considerable differences. Analyses of alignments using peptides (ALLPEPTIDES) show that members of the EPSPS protein family may have less than 25% of common identity in a window of about 450 amino acids (corresponding to the total size of CP4 EPSPS). Despite this low identity level of amino acid sequences, EPSPS family proteins are highly related in terms of structure and function(12). The EPSPS enzyme has no target organism, since it is an enzyme involved in the biochemical way of shikimic acid in plants and microorganisms. Any non target organism that interacts with a plant culture displays a close interaction with a number of plants and microorganisms and therefore is constantly exposed to EPSPS family proteins. Based on the history of occurrence and safe exposure of this protein family, there is no evidence that any EPSPS protein may display biological activity on a non target organism. VI. Restrictions to the use of the GMO and its derivatives According to Article 1 of Law no. 11,460, of March 21, 2007 ”research and cultivation of genetically modified organisms may not be conducted in Amerindian areas and conservation units”. Technical opinions related to agronomic performance reached a conclusion that there is equivalence between transgenic and conventional plants. Thus, this information suggest that transgenic plants are not fundamentally different from the non-transformed corn genotypes, except for the tolerance to glyphosate. Besides, there is no evidence of adverse reactions to the use of NK603 corn. For this reason, there are no restrictions to the use of this corn or its derivatives, either for human or animal feeding. The vertical genic flow to local varieties (the so-called Creole corns) of open pollination is possible and carries the same risk caused by the commercial genotypes available in the market (80% of the conventional corn farmed in Brazil come from commercial seeds that underwent a process of genetic improvement). Coexistence among cultivars of conventional (either cultivated of local varieties) and transgenic cultivars is possible from the agronomic viewpoint(6,20). After ten years of use in different countries, there was no problem detected for human and animal health, or to the environment that may be ascribed to transgenic maize. It shall be emphasized that the lack of negative results in cultivation of transgenic corn plants does not mean that this may not happen. Zero risk coupled with absolute safety is an inexistent combination in the biologic world, although there is a host of trustworthy scientific information and a safe historic of use of ten years that enable us to argue that the NK603 corn is as safe as conventional versions. Therefore, the applicant shall conduct post-commercial release monitoring under CTNBio Ruling Instruction no. 3. VII. Considerations on particulars of different regions of the country (information to supervising bodies) In Brazil, there are no kindred corn species in natural distribution. VIII. Conclusion Whereas: 1. Corn is the species that reached the highest domestication level among cultivated plants, and is unable to survive in nature with no human intervention. 2. In Brazil, there are no wild species with which corn may intercross, since the closest wild corn species is teosinte, found only in Mexico and in some Central America locations, where it may cross with corn cultivated in production fields. 3. There is established knowledge on safety of the use of corn in the human and animal food chain. 4. The transformation event in analysis failed to modify the composition and the nutritional value of corn. 5. There is no evidence that the transgene or the transformation event may cause adverse effects to human and animal health. 6. The history of NK603 corn use in the European Union (since 1999), USA (since 2000) and Canada (since 2001), in addition to the data on field tests conducted in Brazil (since 2000) give sufficient evidence that the kernel and products derived from Glyphosate Tolerant NK603 Corn are as safe as those of conventional corn. 7. There is robust scientific evidence that NK603 corn has no adverse effects on human and animal health, and this information is based in international scientific literature. 8. In 2003, the European Food Safety Authority (EFSA) examined a request for commercial release of NK603 corn and issue a favorable scientific opinion on December 4, 2003, with a conclusion that “NK603 corn is as safe as conventional corn and therefore the marketing of NK603 for processing and its use in human and animal food are unlikely to have any adverse effect on human and animal health or, in this context, on the environment.” 9. Given the detailed data provided by the applicant, the results obtained in control and security essays of the genetically modified organism in analysis, the elements credited to authors of scientific work mentioned and inexistence of evidence contrary to nutritional, toxicological and allergenic security, after thorough investigation, we are favorable to commercial release of NK603 corn for consumption in the human and animal food chain. 10. Corn is a plant that is unable to survive in natural conditions, without technical assistance. This way, there is no likelihood that corn may transform into an invading plant or weed. 11. Environmental safety of the EPSPS family proteins is well accepted, since the proteins are ubiquitous in nature (bacteria, fungi, algae and higher plants), exhibit no known toxicity, are not associated to pathogenicity and fail to grant any selective advantage to plants that do not contain such proteins. 12. In case of a genic escape, the likelihood of fixation of an allele containing the genic sequence that grants tolerance to glyphosate in the population is minimal in absence of selection pressure. 13. Basic interactions of NK603 corn with other organisms in the environment are not held different from interactions of conventional corn. 14. Organisms that are not targets of CP4 EPSPS and CP4 EPSPS L214P, such as predators and preys of corn pests, may be exposed to very low levels of the proteins without, however, evidence of negative effects on such organisms. 15. There is no evidence that any EPSPS protein will have biologic activity on non-target organisms. For the foregoing, and considering internationally accepted criteria in the process of risk analysis for genetically modified raw-materials, a conclusion emerges that Roundup Ready corn, derived from NK603, is as safe as its conventional equivalent. Third party independent scientific studies and publications provided by the applicant were also taken into consideration and consulted. CTNBio holds that the activity is not a potential cause of significant degradation to the environment nor of harm to human and animal health. Restrictions to the use of the GMO analyzed and its derivatives are conditioned to the provisions of CTNBio Ruling Resolutions no. 03 and 04. CTNBio analysis took into consideration opinions issued by members of the Commission and ad hoc consultants; documents delivered by applicant to CTNBio Office of the Executive Secretary; results from planned releases to the environment; lectures, texts and discussion of the public hearing held on 03.20.2007. Also taken into consideration were applicant’s studies and publications, conducted by third parties. 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RAPOPORT E. H.; LADIO A.; RAFFAELE E.; GHERMANDI L.; SANZ E.H. 1998. Malezas Comestíbles. Hay yuyos y yuyos. Ciencia Hoy, v.9. n.49. 53. RAPOPORT E.H.; DRAUSAL B.S. 2001. Edible plants, In: Encyclopedia of biodiversity. LEVIN S. (ed). New York: Academic Press, 375-382. 54. SABHARWAL N.; ICOZ I., SAXENA D.; STOSZKY G. 2007. Release of the recombinant proteins, human serum albumin, beta-glucuronidase, glycoprotein B from human cytomegalovirus, and green fluorescent protein, in root exudates from transgenic tobacco and their effects on microbes and enzymatic activities in soil. Plant Physiol Biochem. 45: 464-469. 55. SAXENA D.; FLORES S.; STOTZKY G. 1999. Insecticidal toxin in root exudates from Bt corn. Nature 402: 480. 56. SHAN G.; EMBREY S.K.; HERMAN R.A.; MCCORMICK R. 2008. Cry1F protein not detected in soil after three years of transgenic Bt corn (1507 corn) use. Environ Entomol. 37:255-62. 57. SHEWRY P.R.; et al.; 2007, Are GM and conventionally Bred Cereals Really Different? Food Sci. Technol. 18: 201.209. 58. SIQUEIRA J.O.; TRANNIN. 2008. Agrossistemas transgênicos. In: Biotecnologia e Meio Ambiente. Borem A.; Giudice M. DEL P. p. 225-309. 59. TAYLOR M.L.; HARTNELL G.F.; RIORDAN S.G.; et al. 2004. Comparison of broiler performance when fed diets containing grain from Roundup Ready (NK603), YieldGard x Roundup Ready (MON 810 X NK603), non-transgenic control, or commercial corn, Poult. Sci. 83: 1758-1758. 60. TAYLOR M.L.; HARTNELL G.; NEMETH M.; KARUNANANDAA K.; GEORGE B. 2005. Comparison of broiler performance when fed diets containing corn grain with insect-protected (corn rootworm and European corn borer) and herbicide-tolerant (glyphosate) traits, control corn, or commercial reference corn-revisted. Poult. Sci. 84: 1493-1899. 61. NUFFIELD COUNCIL ON BIOETHICS. 2004. The use of genetically modified crops in developing countries. 122pp. http://www.nuffieldbioethics.org 62. TRAVIK T.; HEINEMANN J. 2007. Genetic Engineering and Omitted Health Research: Still No answers to ageing questions. Third Word Network, 36p. 63. U.S. FOOD AND DRUG ADMINISTRATION. 2006. Recommendations for the early food safety evaluation of new-pesticidal proteins produced by new plant varieties intended for food use. Center for Food Safety and Applied Nutrition. U.S. Food and Drug Administration. http://www.cfsan.fda.gov/~dms/bioprgu2.htmal 64. VARGAS L.; BIANCHI M.A.; RIZZARDI M.A.; AGOSTINETTO D.; DAL MAGRO T. Conyza bonariensis resiste ao glyphosate na região sul do Brasil. Planta Daninha 25: 573.578. 65. VARGAS L.; RIZZARDI M.A.; BIANCHIM A.; 2007. Manejo e controle de espécies tolerantes ou resistentes ao glifosato. Plantio Direto mar/abr. 2007: p.30-33 66. VIDAL R.A; TREZZI M.M.; STACHLER J., LOUX M. 2007. Definindo resistência aos herbicidas. Plantio Direto jul/ago.2007. 67. VIDAL R.A.Q.; LAMEGO F.P. TREZZI M.M. 2006. Diagnóstico da resistência aos herbicidas em plantas daninhas. Planta Daninha 24: 597-604. 68. WILLIAMS G.M.; KROES R.; MUNRO I.C. 2000. Safety evaluation and risk assessment of the herbicide Roundup and its active ingredient, glyphosate, for humans. Regul. Toxicol. Pharmacol. 31: 117-165. 69. WORD HEALTH ORGANIZATION (WHO). 2005. Modern Food Biotechnology, Hunan Health and Development: An Evidence-Based Study. 76pp. http//www.who.int/foodsafety 70. YASMIN S.; D’SOUZA D. 2007. Effect of pesticides on the reproductive output of Eisena Fetida. Bull. Environ, Contam. Toxical. 79: 529-532.
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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 Commission
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Authorization expiration date (a blank field means there is no expiration date) not applicable
E-mail:
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Maria Sueli Felipe Soares
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556134115516
Fax number:
556133177475
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.

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Stacked events:

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

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

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

Canada
Name of product applicant: Monsanto Canada Inc.
Summary of application:
The 603 line of corn (Zea maysL.) was developed through a specific genetic modification to be tolerant to glyphosate containing herbicides. This novel variety was developed from an inbred dent corn line by insertion of a bacterial 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) encoding gene which provides enhanced tolerance to glyphosate compared to the native corn EPSPS.

Glyphosate specifically binds to and inactivates EPSPS, which is involved in the biosynthesis of the aromatic amino acids tyrosine, phenylalanine and tryptophan. This enzyme is present in all plants, bacteria and fungi, but not in animals, which do not synthesize their own aromatic amino acids. Thus, EPSPS is normally present in food derived from plant and microbial sources. The modified corn line permits farmers to use glyphosate containing herbicides, such as Roundup®, for weed control in the cultivation of corn.

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Date of authorization: 19/02/2001
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): BioTrack Product Database
Summary of the safety assessment (food safety):
Please see decision document weblinks
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Novel Foods Decision
Novel Feeds Decision
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
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.

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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

Colombia
Name of product applicant: Compañia Agricola S.A.S
Summary of application:

Authorization of the genetically modified maize NK603 tolerant to herbicide glyphosate 

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Date of authorization: 27/09/2019
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Based on the risk assessment, it can be concluded that the event shows the same risks as its conventional counterpart. Therefore the National Technical Biosafety Committee for GMO use exclusively in Health and human consumption (CTNSalud) recommends its authorization.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministerio de salud y proteccion social
Contact person name:
Daniel Rubio
Website:
Physical full address:
Carrera 13 No. 32- 76 piso 12, Bogotá
Phone number:
330 5000 ext 1256
Fax number:
Country introduction:

The 4525 decree of 2005, established the Ministry of Health and Social Protection as the competent authority for GMO for health and food purposes and creates the National Biosafety Technical Committee for GMO's used in health and food purposes (CTNSalud).

The CTNSalud is composed by the Ministry of Health and Social Protection, the National Food and Drug Surveillance Institute (INVIMA) and the Technology and Innovation Administrative Department (COLCIENCIAS). This committee is responsible for the assesment of risk assessments; to inquire for any additional information; assessment of any measurements in accordance to the Cartagena Protocol; and the recommendation for the authorization of GMO for health or food purposes.

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Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Indonesia
Name of product applicant: Monsanto Indonesia (PT. Branita Sandhini)
Summary of application:

Genetically modified maize line NK 603 expresses the CP4 EPSPS protein which confers tolerance to the glyphosate herbicides.

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Date of authorization: 22/02/2011
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Please see the relevant document below.
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Indonesian Agency for Agricultural Research and De
Contact person name:
Sustiprijatno
Website:
Physical full address:
BB Biogen Jl Tentara Pelajar 3A Bogor 16111 Indonesia
Phone number:
+622518333440
Fax number:
+622518334420
Country introduction:
  1. 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.
  2. 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.  
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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

Iran
Name of product applicant: Kala Tejarat Khalij Fars
Summary of application:

MON-ØØ6Ø3-6 - Roundup Ready™ maize for direct use as food or processing.

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Date of authorization: 06/01/2019
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Competent National Authority: Ministry of Health and Medical Education- Food & Drug Administration. Risk Assessment file is uploaded.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Iran Standard and Industrial Research Institute
Contact person name:
Behzad Ghareyazie
Website:
Physical full address:
No 5, Bijan Alley, Jahanshahr, Karaj
Phone number:
00989121271496
Fax number:
00982632704539
Country introduction:

Iran has ratified Cartagena Protocol on Biosafety in 2003. The National Biosafety Law has also been ratified in 2009. The regulation for the National Biosafety Law is under the review. All these laws and regulations deal with Living GMOs (LMOs) and there is no Law for the regulation of the non-living GMOs. All these laws and regulations are accessible at: http://bch.cbd.int/database/results?searchid=622770. Codex principles for the risk analysis of foods derived from modern biotechnology and other guidelines such as the Codex guidelines for the conduct of food safety assessment of foods produced using recombinant-DNA plants and microorganisms are widely accepted and used.

The process for authorization of new LMO release includes comprehensive risk assessment and management analysis. Ministry of Agriculture (Jihade Keshavarzi) is responsible for approval of the release, import, export, transit and use of Agricultural Related LMOs. The requests should be forwarded to: [email protected]; with a CC to National Focal Point: [email protected]. Cartagena Protocol on Biosafety National Focal Point is in charge of all liaison affairs related to the Cartagena Protocol on Biosafety and acts as the contact point for the communications received. The Ministry of Health and Medical Education is in charge with the approval of all LMOs related to food and medicine. Environmental Protection Organization is in charge with the environmental release of LMOs in the wild nature and/or related to the wild organisms. Detailed procedure for authorization of GM food and feed is under preparation.

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Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Agricultural Jihad Ministry
 
Tehran, Tehran
Iran (Islamic Republic of)
Phone: +98-21-64583301
Fax: +98-21-88947075
Email: [email protected]
Url: http://www.maj.ir

 

Ministry of Health and Medical Education- Food & Drug Administration
Food and Drug Administration, Fakhrerazi St., Enghelab Ave.
Tehran
Iran (Islamic Republic of), 1314715311
Phone: 009821-61927130
Fax: 009821-66405570
Email: [email protected],[email protected]
Url: http://fda.behdasht.gov.ir/

 

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

Maize tolerant to glyphosate herbicide (cp4 epsps, Zea mays subsp. mays (L.) Iltis).

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Date of authorization: 30/03/2001
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): BioTrack Product Database
Summary of the safety assessment (food safety):
Please see the link below (in Japanese).
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Food safety assessment performed by Ministry of Health, Labour and Welfare of Japan (in Japanese)
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,
Contact person name:
Mariko Murakami
Website:
Physical full address:
Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number:
81 3 6234 1122
Fax number:
81 3 3584 7392
Country introduction:
Safety assessments of GM foods are mandatory under the Food Sanitation Law in Japan. The Ministry of Health, Labour, and Welfare (MHLW) legally imposes safety assessments of GM foods so that those that have not undergone safety assessments would not be distributed in the country. MHLW receives application and requests the Food Safety COmmission of Japan (FSCJ) to evaluate the safety of GM foods in terms of human health. Safety assessments are carried out by FSCJ.
Useful links
Relevant documents
Stacked events:

With regard to stacked events, FSCJ conducts the safety assessment of GM food based on the “Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants”.

Even if single events that are stacked have already approved, some products will be considered as new products and some will not.

Please refer to Article 5 and 6 of the MHLW’s notice, which is available at the following URL, for the details.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000053519.pdf

Article 6 was modified in 2014, and the modified version is available at the following URL.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000049695.pdf

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

Food Safety Commission of Japan (http://www.fsc.go.jp/english/index.html), Ministry of Health, Labour and Welfare (http://www.mhlw.go.jp/english/policy/health-medical/food/index.html)

Malaysia
Name of product applicant: Monsanto
Summary of application:
Please refer to uploaded document.
Upload:
Date of authorization: 19/09/2008
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Malaysia Biosafety Clearing House
CBD Biosafety Clearing House
Summary of the safety assessment (food safety):
Please refer to uploaded document.
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Department of Biosafety Malaysia
Contact person name:
Dr. Anita Anthonysamy
Website:
Physical full address:
Department of Biosafety Ministry of Environment and Water 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.

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

Department of Biosafety Malaysia, Level 1, Podium 2, Wisma Sumber Asli No. 25, Persiaran Perdana, Precinct 4 Putrajaya, Federal Territory Malaysia, 62574. Phone: +603 8886 1746 / 1579. Fax: +603-8889 5604 Email: [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]
Mexico
Name of product applicant: Monsanto Comercial, S.A. de C.V.
Summary of application:

Authorization by COFEPRIS: 16


Maize tolerant to glyphosate herbicide (cp4 epsps, Zea mays subsp. mays (L.) Iltis).

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Date of authorization: 07/06/2002
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.):
Summary of the safety assessment (food safety):
UI OECD: MON-ØØ6Ø3-6 During the risk assessment of this GMO based on existing knowledge to date, no toxic or allergic effects neither substantial nutritional changes are observed. The event is as safe as its conventional counterpart. For more detail please find attached the risk assessment summary in this page.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
CIBIOGEM
Contact person name:
Biól. Erica L. Hagman Aguilar
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

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

Secretaría de Salud / Phone: +52 55 5080 5200 /Email: [email protected]%20

New Zealand
Name of product applicant: Monsanto Australia Ltd
Summary of application:

Glyphosate is the active ingredient of the proprietary herbicide Roundup® which is used widely as a non-selective agent for controlling weeds in primary crops. The corn is known commercially as Roundup Ready (RR) corn line NK603.

Glyphosate directly affects the shikimate biosynthetic pathway in plants. The mode of action of glyphosate is to specifically bind to and block the activity of 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS), an essential enzyme involved in the biosynthesis of aromatic amino acids in all plants, bacteria and fungi. Blocking the enzyme results in the breakdown of the synthesis of essential aromatic amino acids in cells, ultimately leading to the death of the plant.

Biochemical studies on the EPSPS enzyme from a variety of different species have shown that a natural variation in glyphosate binding affinity exists, particularly across bacterial species (Schultz et al. 1985). Tolerance to glyphosate in plants can therefore be achieved by introducing a bacterial version of the EPSPS gene producing a protein with a reduced binding affinity for glyphosate, thus allowing the plant to function normally in the presence of the herbicide.

In glyphosate-tolerant corn line NK603, the herbicide-tolerance trait is generated in the plants through the addition of a bacterial EPSPS gene derived from a common soil bacterium, Agrobacterium sp. strain CP4 (CP4 EPSPS). The enzyme produced from the introduced gene has a reduced affinity for the herbicide compared with the corn enzyme, and thus imparts glyphosate tolerance to the whole plant.

The bacterial CP4 EPSPS is used also in Roundup Ready varieties of soybean, canola,
sugar beet and cotton. Foods derived from these modified crop lines have previously been assessed for safety by ANZFA and have been approved5 for food use in Australia and New Zealand under Standard A18 – Food Produced Using Gene Technology in Volume 1(Standard 1.5.2 in Volume 2) of the Food Standards Code.

Corn is used predominantly as an ingredient in the manufacture of breakfast cereals, baking products, extruded confectionery and corn chips. Maize starch is used extensively by the food industry for the manufacture of many processed foods including dessert mixes and canned foods.

Despite the diverse uses of corn products in many foods, corn is a relatively minor crop in both Australia and New Zealand, with a declining area planted over the last decade. Consequently, there is a requirement to import products such as high-fructose corn syrup and maize starch to meet manufacturing demand. The glyphosate-tolerance trait has not been introduced into sweet corn or popcorn varieties and therefore the whole kernel from corn line NK603 is not consumed directly as food, but rather is processed into various corn fractions.

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Date of authorization: 20/12/2002
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): OECD BioTrack Product Database
Summary of the safety assessment (food safety):
Food derived from glyphosate-tolerant corn line NK603 has been evaluated according to the safety assessment guidelines prepared by ANZFA. The assessment considered the following issues: (1) the nature of the genetic modification; (2) general safety issues such as novel protein expression and the potential for transfer of novel genetic material to cells in the human digestive tract; (3) toxicological issues; and (4) nutritional issues. On the basis of the submitted scientific data and other available information, ANZFA has concluded that food derived from glyphosate-tolerant corn line NK603 is as safe and wholesome as food from other commercial varieties of 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:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Application A416 - To amend Standard A18 - Food produced using Gene Technology - Glyphosate-Tolerant Corn Line NK603
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministry for Primary Industries
Contact person name:
Fiapaipai Auapaau
Website:
Physical full address:
Pastoral House, 25 The Terrace, Wellington, 6012
Phone number:
+6448314946
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.

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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:

Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)

Philippines
Name of product applicant: Monsanto Philippines
Summary of application:

On March 29, 2019, Monsanto Philippines submitted corn NK603 as a renewal application for commercial propagation to the Bureau of Plant Industry (BPI) under the DOST-DA-DENR-DOH-DILG Joint Department Circular (JDC) No. 1 Series of 2016. After reviewing the Risk Assessment Report and attachments submitted by the applicant the Scientific and Technical Review Panel (STRP), has stated that corn NK603 is as safe for human food and animal feed as its conventional counterpart.

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Date of authorization: 29/05/2019
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Toxicological Assessment SDS-PAGE and Western blot methods were used in assessing the digestibility of corn NK603 CP4 EPSPS proteins (CP4 EPSPS and CP4 EPSPS L214P) in simulated gastric fluid (SGF, containing pepsin). Results from these experiments demonstrated that CP4 EPSPS produced from E. coli were rapidly digested after incubation in SGF. The SDS-PAGE Colloidal Blue gel staining method demonstrated that at least 98% of the E. coli-produced CP4 EPSPS proteins were digested in SGF within 15 seconds and the estimated T50 result for SGF is below 15 seconds. There were no observed protein bands due to degradation of the CP4 EPSPS. Western blot analysis confirmed that greater than 95% of the E. coliproduced CP4 EPSPS proteins were digested in SGF within 15 seconds. The estimated T50 CP4 EPSPS is less than 15 minutes and was determined in the temperature dependence studies which demonstrated that the enzymatic activity is eliminated after 15 minutes incubation at 65°C. The impact of heating and in vitro digestibility of CP4 EPSPS has also been confirmed by Okunuki et al. (2002). Upon comparison of amino acid sequences of the CP4 EPSPS to protein sequences in the toxin database using the FASTA sequence alignment tool, the protein shared sequence similarities to homologous EPSPS proteins which have not been described as toxins relevant to human health. No other significant structural homology was observed. Acute oral toxicity study was conducted with E. coli-produced CP4 EPSPS protein and was administered as a single dose by gavage to three groups of 10 male and 10 female CD-1 mice at dose levels up to 572 mg/kg. Results show that there were no treatment-related effects on survival, clinical observations, body weight gain, food consumption or gross pathology. Therefore, the No Observable Adverse Effect Level (NOAEL) for CP4 EPSPS was considered to be 572 mg/kg. Allergenicity Assessment The amino acid sequence of the CP4 EPSPS protein was compared to a database of protein sequences associated with allergy and celiac disease using the sequence alignment tool FASTA and demonstrated that CP4 EPSPS shared no structurally significant sequence similarity to sequences within the allergen database. In addition, the CP4 EPSPS sequence was compared to the allergen database using an algorithm that scans for a window of eight linearly contiguous identical amino acids and results showed that The CP4 EPSPS protein sequence does not share eight linearly contiguous amino acid identities to any sequence in the allergen database. These results confirm that the CP4 EPSPS protein does not share any relevant amino acid sequence similarities with known allergens, gliadins, or glutenins. Further analysis of the physicochemical and functional properties provides a detailed characterization of the corn NK603-produced CP4 EPSPS and CP4 EPSPS L214P proteins and establish its equivalence to the E. coli-produced CP4 EPSPS proteins. Nutritional Data Results of the study provided shows that there were no statistically significantly differences observed for proximate analysis in forage grain and antinutrients between corn NK603 and the conventional control. Reference grain and forage samples from the E.U. field trials also included 19 conventional, commercial hybrids (five hybrids per site with one hybrid planted at two sites), planted under the same environmental conditions. All test values of proximate were within the 99% tolerance interval established from the commercial varieties. The studies provided by the applicant show that all test values of forage, grain and antinutrients were within or similar to literature range or historical range. Differences observed in key nutrients were not biologically relevant and meaningful from a food and feed safety perspective.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
Upload:
Authorization expiration date (a blank field means there is no expiration date) May 28, 2024
E-mail:
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Geronima P. Eusebio
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 404 0409 loc 203
Fax number:
Country introduction:

In 1987, scientists from the University of the Philippines Los Banos (UPLB) and the International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI), and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD), recognizing the potential harm of the introduction of exotic species and genetic engineering, formed a committee and formulated the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. The committee went on to draft a Philippine biosafety policy, which was submitted to the Office of the President. On October 15, 1990, recognizing the potential for modern biotechnology both in improving the lives of the people and in creating hazards if not handled properly, President Corazon C. Aquino issued Executive Order 430 creating the National Committee on Biosafety of the Philippines (NCBP) that will formulate, review and amend national policy on biosafety and formulate guidelines on the conduct of activities on genetic engineering. The NCBP is comprised of representative of the Departments of Agriculture (DA); Environment and Natural Resources (DENR); Health (DOH); and Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science; and 2 respected members of the community. On July 16, 2001, President Gloria Macapagal-Arroyo issued the Policy Statement on Modern Biotechnology, reiterating the government policy on promoting the safe and responsible use of modern biotechnology. On April 3, 2002, Department of Agriculture Administrative Order No. 8, Series of 2002 was issued implementing the guidelines for importation and release into the environment of Plants and Plant Products Derived from the Use of Modern Biotechnology. On March 17, 2006, President Gloria Macapagal-Arroyo issued Executive Order No.514 Establishing the National Biosafety Framework, prescribing guidelines for its implementation, reorganizing the National Committee on Biosafety of the Philippines, and for other purposes. On December 8, 2015, the Philippine Supreme Court declared DA AO8 null and void and any application for contained use, field testing, propagation and commercialization, and importation of GMOs was temporarily enjoined. In response to the nullification of DA AO8, the Technical Working Group composed of representatives from the Departments of Agriculture (DA), Science and Technology (DOST), Environment and Natural Resources (DENR), Health (DOH), and Interior and Local Government (DILG) drafted the Joint Department Circular No. 1, Series of 2016 (JDC No.1, S2016) titled 'Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically-Modified Plant and Plant Products Derived from the Use of Modern Biotechnology'. There were series of meeting and five public consultations conducted before the JDC No.1, S2016 was approved and signed by the Secretaries of the abovementioned agencies on March 7, 2016 and took effect on April 15, 2016. Under this Circular, more government agencies were involved such as the Department of Science and Technology (DOST) to regulate applications for contained use and confined test of regulated articles; Department of Agriculture (DA) to evaluate applications for field trial, commercial propagation and transboundary movement of regulated articles; Department of Environment and Natural Resources (DENR) to evaluate environmental risks and impacts of regulated articles; Department of Health (DOH) to evaluate of environmental health impacts of regulated articles; and Department of the Interior and Local Government (DILG) to supervise public consultation during field trial.

 

Useful links
Relevant documents
Stacked events:

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

 

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

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

(a) genetic engineering, or

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

Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:

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

Notificatlon Requirement for Plant Products Carrying Stacked Genes

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

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

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

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

Philippines
Name of product applicant: Monsanto Philippines Inc.
Summary of application:

On March 29, 2019, Monsanto Philippines submitted corn NK603 as a renewal application for commercial propagation to the Bureau of Plant Industry (BPI) under the DOST-DA-DENR-DOH-DILG Joint Department Circular (JDC) No. 1 Series of 2016. After reviewing the Risk Assessment Report and attachments submitted by the applicant the Scientific and Technical Review Panel (STRP), has stated that corn NK603 is as safe for human food and animal feed as its conventional counterpart.

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Date of authorization: 29/05/2019
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
1. Host Organism a. Generally, corn does not contain known allergens or produce significant toxins or antinutrients warranting analytical or toxicological tests. However, in some casestudies, allergenic reactions were reported [3][4]. b. Maize or corn is being consumed in varied forms. It can be eaten raw. Most of the human consumption of maize is in the form of maize-based ingredients such as high fructose corn syrup, starch, sweeteners, cereals, oil and alcohol [3]. 2. Transgenic Plant a. Corn NK603 has been reviewed and approved for food and/or feed use in many countries which were listed by the applicant. In terms of food and feed safety, results from compositional studies support the overall conclusion that corn NK603 was not a major contributor to variation in component levels in maize grain and forage and confirmed the compositional equivalence of corn NK603 to the conventional control in levels of these components [3][4][5]. b. Since corn NK603 was found to be substantially equivalent to conventional maize with similar genetic background, there is no anticipated change in the use pattern for the product [3][5]. 3. The Donor Organism a. Agrobacterium sp. strain CP4 is the donor organism for corn NK603 and is not known to be toxic or allergenic [3]. b. CP4 EPSPS protein is not known to be toxic or allergenic. CP4 EPSPS protein produced in corn NK603 is also present in many commercial biotechnologyderived crops and that a history of the safe use of CP4 EPSPS protein has been demonstrated [3]. 4. Transformation System a. Plasmid vector PV-ZMGT32 developed by Monsanto Company, was used for the transformation of maize to produce NK603 and a detailed description of the expression cassette was adequately provided by the applicant [3][6] [8]. b. Particle acceleration transformation was the method used and the complete experimental protocol was provided by the applicant [3]. 5. Inserted DNA Validation of the results from molecular analyses confirmed that corn NK603 contains a single copy of T-DNA containing the cp4 epsps expression cassettes that is 5 stably integrated at a single insertion site and no detectable additional genetic elements. The result was demonstrated sufficiently by Southern blot analysis and PCR and sequence analysis [3][8]. 6. Genetic Stability a. The potential for creating novel chimeric ORFs were tested by PCR and DNA sequencing which verified the 5’ and 3’ ends of the insert in corn NK603. The sequences flanking the insert were confirmed to be native to maize. Western blot confirmed the expression of the full-length CP4 EPSPS proteins in corn NK603 and results indicate that the two CP4 EPSPS proteins are indistinguishable in Western blot analysis with the available polyclonal antibody, since the proteins are essentially identical. The reported data support the conclusion that only the two full-length CP4 EPSPS proteins are encoded by the insert in corn NK603 [3][8]. b. The reported data show that corn NK603 does not contain backbone sequences from the backbone sequences. This was sufficiently demonstrated by Sacl restriction enzyme digestion, hybridization and Southern blotting. [3][7]. c. The reported results from Southern blot analysis demonstrated the stability of the DNA insert across multiple generations on F1 generation and the fifth generation of back-crossing of corn NK603. The analysis confirmed that a single integration locus was maintained through five generations of breeding, thereby confirming the stability of the insert [3][7]. 7. Expressed Material The reported mean level of CP4 EPSPS proteins in forage was 25.6 qg/g tissue on a fresh weight basis while the level of CP4 EPSPS proteins in grain from event NK603 was 10.9 tig/g tissue. This was measured by performing a double antibody sandwich enzyme-linked immunosorbent assay (ELISA) from the collected forage and grain tissues from the field sites treated with glyphosate in the U.S. Other relevant information in this methodology was provided by the applicant [3][9]. 8. Toxicological Assessment a. SDS-PAGE and Western blot methods were used in assessing the digestibility of corn NK603 CP4 EPSPS proteins (CP4 EPSPS and CP4 EPSPS L214P) in simulated gastric fluid (SGF, containing pepsin). Results from these experiments demonstrated that CP4 EPSPS produced from E. coli were rapidly digested after incubation in SGF. The SDS-PAGE Colloidal Blue gel staining method demonstrated that at least 98% of the E. coli-produced CP4 EPSPS proteins were digested in SGF within 15 seconds and the estimated T50 result for SGF is below 15 seconds. There were no observed protein bands due to degradation of the CP4 EPSPS. Western blot analysis confirmed that greater than 95% of the E. coliproduced CP4 EPSPS proteins were digested in SGF within 15 seconds [3][10][11]. b. The estimated T50 CP4 EPSPS is less than 15 minutes and was determined in the 6 temperature dependence studies which demonstrated that the enzymatic activity is eliminated after 15 minutes incubation at 65°C. The impact of heating and in vitro digestibility of CP4 EPSPS has also been confirmed by Okunuki et al. (2002).[12][13]. c. Upon comparison of amino acid sequences of the CP4 EPSPS to protein sequences in the toxin database using the FASTA sequence alignment tool, the protein shared sequence similarities to homologous EPSPS proteins which have not been described as toxins relevant to human health. No other significant structural homology was observed [3][11][14]. d. Acute oral toxicity study was conducted with E. coli-produced CP4 EPSPS protein and was administered as a single dose by gavage to three groups of 10 male and 10 female CD-1 mice at dose levels up to 572 mg/kg. Results show that there were no treatment-related effects on survival, clinical observations, body weight gain, food consumption or gross pathology. Therefore, the No Observable Adverse Effect Level (NOAEL) for CP4 EPSPS was considered to be 572 mg/kg [3][15]. 9. Allergenicity Assessment a. The amino acid sequence of the CP4 EPSPS protein was compared to a database of protein sequences associated with allergy and celiac disease using the sequence alignment tool FASTA and demonstrated that CP4 EPSPS shared no structurally significant sequence similarity to sequences within the allergen database. b. In addition, the CP4 EPSPS sequence was compared to the allergen database using an algorithm that scans for a window of eight linearly contiguous identical amino acids and results showed that The CP4 EPSPS protein sequence does not share eight linearly contiguous amino acid identities to any sequence in the allergen database. c. These results confirm that the CP4 EPSPS protein does not share any relevant amino acid sequence similarities with known allergens, gliadins, or glutenins. Further analysis of the physicochemical and functional properties provides a detailed characterization of the corn NK603-produced CP4 EPSPS and CP4 EPSPS L214P proteins and establish its equivalence to the E. coli-produced CP4 EPSPS proteins [3][11][14][16]. 10.Nutritional Data a. Results of the study provided shows that there were no statistically significantly differences observed for proximate analysis in forage grain and antinutrients between corn NK603 and the conventional control [3][17][18][19][20]. b. Reference grain and forage samples from the E.U. field trials also included 19 conventional, commercial hybrids (five hybrids per site with one hybrid planted at two sites), planted under the same environmental conditions. All test values of proximate were within the 99% tolerance interval established from the 7 commercial varieties [3][17][18][19][20]. c. The studies provided by the applicant show that all test values of forage, grain and antinutrients were within or similar to literature range or historical range [3] [19][20] d. Differences observed in key nutrients were not biologically relevant and meaningful from a food and feed safety perspective [3][17][18][19][20]. 11.The Host Plant Environment a. Maize is a wind pollinated species with plant morphology that facilitates cross pollination [21]. b. The references provided by the applicant on hybridization with cultivated Zea mays L., wild annual species of subgenus Zea mays subsp. mexicana, wild perennial species of subgenus Tripsacum have described the possible formation of viable interspecific and/or intergeneric hybrids. From the studies provided, there are no scientific reports confirming the transfer of genetic material from maize to other species with which maize cannot sexually interbreed. Thus, the probability for horizontal gene flow to occur is negligible [22][23][24]. 12.The Consequences of Outcrossing a. In the Philippines, there is no known sexually compatible wild species. This among other factors reported by the applicant support that the assessment that the risk of loss of this wild species due to the development of the GM variety is very low [22][25]. b. There are no anticipated changes in habitat or geographic distribution. Corn NK603 has been shown to be no different from conventional maize in its phenotypic, ecological, and compositional characteristics, except for the introduced trait of glyphosate tolerance [6]. 13.Weediness Potential a. There is no adverse environmental impact is expected from the introduction of Corn NK603 to pests and/or diseases on current cultivation and management practices for maize. As shown by previous studies, corn NK603 has been shown to be no different from conventional maize in its phenotypic, ecological, and compositional characteristics, except for the introduced trait of glyphosate tolerance [6]. b. Mode of dissemination is through seeds. Plant produces a male (tassel) and female (ear) flower borne on the same plant but different positions. A well-developed ear shoot has 750 to 1,000 ovules (potential kernels), each producing a silk. However, under good conditions only 400 to 600 ovules will be fertilized and eventually produce kernels. Under favorable conditions, a pollen grain upon landing on a receptive silk will develop a pollen tube containing the male genetic material, develop and grow inside the silk, and fertilize the female ovary within 24 hours. 8 Pollen grains are borne in anthers, each of which contains a large number of pollen grains. The anthers open and the pollen grains pour out after dew has dried off the tassels. Pollen is light and can be carried considerable distances by the wind. However, most of it settles within 6 to 15 meters (20 to 50 feet). Pollen shed is not a continuous process. It stops when the tassel is too wet or too dry and begins again when temperature conditions are favorable [21]. STRP’S RECOMMENDATION Find sufficient evidence that the regulated article applied for direct use will not pose any significant risk to health and environment as its conventional counterpart and that any risks posed to health and environment could be managed by the following measures; 1. Continuous monitoring of planted sites for weed shifts and herbicide resistance development. 2. Product stewardship. 3. Provision of guidance on the planting of corn NK603 in hilly areas.
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
Upload:
Authorization expiration date (a blank field means there is no expiration date) May 28, 2024
E-mail:
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Geronima P. Eusebio
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 404 0409 loc 203
Fax number:
Country introduction:

In 1987, scientists from the University of the Philippines Los Banos (UPLB) and the International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI), and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD), recognizing the potential harm of the introduction of exotic species and genetic engineering, formed a committee and formulated the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. The committee went on to draft a Philippine biosafety policy, which was submitted to the Office of the President. On October 15, 1990, recognizing the potential for modern biotechnology both in improving the lives of the people and in creating hazards if not handled properly, President Corazon C. Aquino issued Executive Order 430 creating the National Committee on Biosafety of the Philippines (NCBP) that will formulate, review and amend national policy on biosafety and formulate guidelines on the conduct of activities on genetic engineering. The NCBP is comprised of representative of the Departments of Agriculture (DA); Environment and Natural Resources (DENR); Health (DOH); and Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science; and 2 respected members of the community. On July 16, 2001, President Gloria Macapagal-Arroyo issued the Policy Statement on Modern Biotechnology, reiterating the government policy on promoting the safe and responsible use of modern biotechnology. On April 3, 2002, Department of Agriculture Administrative Order No. 8, Series of 2002 was issued implementing the guidelines for importation and release into the environment of Plants and Plant Products Derived from the Use of Modern Biotechnology. On March 17, 2006, President Gloria Macapagal-Arroyo issued Executive Order No.514 Establishing the National Biosafety Framework, prescribing guidelines for its implementation, reorganizing the National Committee on Biosafety of the Philippines, and for other purposes. On December 8, 2015, the Philippine Supreme Court declared DA AO8 null and void and any application for contained use, field testing, propagation and commercialization, and importation of GMOs was temporarily enjoined. In response to the nullification of DA AO8, the Technical Working Group composed of representatives from the Departments of Agriculture (DA), Science and Technology (DOST), Environment and Natural Resources (DENR), Health (DOH), and Interior and Local Government (DILG) drafted the Joint Department Circular No. 1, Series of 2016 (JDC No.1, S2016) titled 'Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically-Modified Plant and Plant Products Derived from the Use of Modern Biotechnology'. There were series of meeting and five public consultations conducted before the JDC No.1, S2016 was approved and signed by the Secretaries of the abovementioned agencies on March 7, 2016 and took effect on April 15, 2016. Under this Circular, more government agencies were involved such as the Department of Science and Technology (DOST) to regulate applications for contained use and confined test of regulated articles; Department of Agriculture (DA) to evaluate applications for field trial, commercial propagation and transboundary movement of regulated articles; Department of Environment and Natural Resources (DENR) to evaluate environmental risks and impacts of regulated articles; Department of Health (DOH) to evaluate of environmental health impacts of regulated articles; and Department of the Interior and Local Government (DILG) to supervise public consultation during field trial.

 

Useful links
Relevant documents
Stacked events:

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

 

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

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

(a) genetic engineering, or

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

Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:

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

Notificatlon Requirement for Plant Products Carrying Stacked Genes

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

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

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

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

Republic of Korea
Name of product applicant: DuPont (Korea) Inc.
Summary of application:

Glyphosate herbicide tolerance


 

Upload:
Date of authorization: 26/12/2002
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Please to see link below(in Korean).
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministry of Food and Drug Safety
Contact person name:
Website:
Physical full address:
Osong Health Technology Administration Complex, 187, Osongsaengmyeong 2-ro, Osong-eup, Cheongwon-gun, Chungcheonbuk-do, 363-700, Korea
Phone number:
82-43-719-2360
Fax number:
Country introduction:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Russian Federation
Name of product applicant: Monsanto Company
Summary of application:

There were submitted (1) data enabling to identify the matter of research (species, variety, and the transformation event); (2) data on the initial parental organism and the donor organism for introduced genetic sequences;  (3) data on the genetic modification method, genetic construction, and the level of gene expression; (4) data on identification of GM maize line NK603 (identification methods, protocol of analysis, description of primers, reference materials); (5) data on registration of the GM line  in other countries and the results of safety assessment which conducted for registration purposes of GMO in other countries.

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Date of authorization: 16/05/2002
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
By all examined parameters, the data of complex safety assessment of transgenic maize line NK 603, tolerant to glyphosate, attest to the absence of any toxic, genotoxic, immune system modulating, or allergenic effects of this maize line. By chemical composition, transgenic maize line NK 603 was identical to conventional maize. Based on the results of the studies, the State Sanitation Service of the Russian Federation (Department of State Sanitation and Epidemiological Inspectorate) granted the Registration Certificate which allows the transgenic maize line NK 603 to be used in the food industry and placed on the market without restrictions. More information is on P. 158-175 of monograph ”Genetically Modified Food Sources. Safety Assessment and Control”, published by Elsevier Inc. Academic Press in 2013, the uploaded file.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
FSBI «Institute of Nutrition» RAMS
Contact person name:
Nadezhda Tyshko
Website:
Physical full address:
109240, Russia, Moscow, Ustinsky Proezd, 2/14
Phone number:
+7(495)698-53-64
Fax number:
Country introduction:

The development of the GMO safety assessment currently used in the Russian Federation started in 1995–1996. The methodological approaches to comprehensive complex medical and biological assessment of GMOs were developed in the Russian Federation with due regard for international and national experience as well as new scientific approaches based on the achievements of contemporary fundamental science: genomic and proteomic analysis, detection of DNA damage or mutagenic activity, identification of products of free-radical modifications of DNA or other sensitive biomarkers. GMO safety assessment is carried out for the state registration. Any novel food derived from plant GMO produced in Russia or imported into Russia for the first time is subject to the state registration . Guidance for safety assessment is specified in MU 2.3.2.2306-07 “Medico-Biological Safety Assessment of Plant Genetically Modified Organisms”. According to the accepted regulations,the human health assessment of a novel GMO to be placed on the domestic market includes the following: ■ Molecular assessment includes analysis of genetic construction, genetic modification method, and the gene expression level. ■ Technological assessment includes determination of organoleptic and functional properties, analysis of technological characteristics of the finished products. ■ Human health safety assessment includes several sections of required assessments: analysis of compositional equivalence and toxicological,genotoxicological, and allergological safety studies. ■ Methods for identification include qualitative and quantitative assay of GMO in food (studies targeted at determination of correspondence of these methods to those used in Russia in order to provide monitoring of use and labeling of GM food). The list and the scope of required studies is determined on the basis of analysis of information of the GMO submitted for registration; however, the above-mentioned studies are required. If significant changes in the GMO’s genome, proteome, or metabolome are shown, additional studies may be required to determine: biological value and absorbency reproductive effect; gonadotoxic, embryotoxic, teratotoxic effect; potential carcinogenic effect; lifetime, etc.

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Relevant documents
Stacked events:

Russia follows the national Methodical Guidelines  2.3.2.3388-16 “Medical and biological safety assessment of genetically modified stack events of plant origin ”

Our position regarding GM stacks registration is very close to the EU approach.

 

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

Federal Research Centre of nutrition and biotechnology Viktor A. Tutelyan Ustinsky proezd, 2/14 109240 Moscow, RUSSIA E-mail: [email protected] Tel.:+7 495 698-53-60

Singapore
Name of product applicant: Monsanto
Summary of application:

Apply for use as food, feed or as ethanol

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Date of authorization: 23/05/2006
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Corn line NK603 (MON-00603-6) is tolerant to glyphosate. It is generated through the addition of a bacterial EPSPS gene derived from Agrobacterium sp. strain CP4 (CP4 EPSPS). The enzyme produced from the CP4 EPSPS gene has a reduced affinity for the herbicide compared with the corn enzyme, and thus confers glyphosate tolerance to the plant. NK603 contains two linked copies of the CP4 EPSPS gene, each with separate regulatory sequences. No extraneous bacterial genes were transferred. CP4 EPSPS protein and the sequence variant CP4 EPSPS L214P (which differs by one amino acid from the expected protein sequence as a result of a nucleotide change to one to the transferred CP4 EPSPS genes) are non-toxic and non-allergenic to humans. Composition analyses showed that grain from NK603 corn was equivalent in composition to that of other commercial corn varieties. Food derived from NK603 corn is considered as safe as food derived from other corn varieties.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
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:

More information on the guidelines for the safety assessment of stacked events can be found on GMAC’s website:

http://www.gmac.sg/Index_Singapore_Guidelines_on_the_Release_of_Agriculture_Related_GMOs.html

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

Singapore Food Agency (SFA)

Turkey
Name of product applicant: Special case: please show below
Summary of application:

 


Application for direct use as feed


 


Turkish Biosafety Law, entered in force in 2010, diverges from EU legislations in some points
 such as food and feed use require different separate applications, risk assessments and approvals.
  Addition, our Law forsees prision sentences in some circumtances of Law violation and joint
 reponsibilities for the violation. Therefore, GM product owners avoid to make application for approval
and non product developer have made application till now. Instead, some Turkish assosiations
 such as poultry producers assosiations, animal feed assosiations have applied to get approval
for import of GM products for their members. Thus, name of product applicants are not product
developers for our country.


 


Turkish Feed Manufacturer's Association
Turkish Poultry Meat Producers and Breeders Association
Turkish Egg Producers Association


 

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Date of authorization: 24/12/2011
Scope of authorization: Feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
After the evaluation of reports released by Scientific Risk Assessment Committee and Socio- economic Assessment Committee and also by considering public opinion, Biosafety Board has approved the use of genetically modified maize NK603 and products thereof for animal feed.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
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]

United States of America
Name of product applicant: Monsanto Company
Summary of application:
Corn
Trait 1 Added Protein: 5-Enolpyruvylshikimate-3-phosphate synthase (EPSPS)
Source: Agrobacterium sp. strain CP4
Intended Effect: Tolerance to the herbicide glyphosate
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Date of authorization: 18/10/2000
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Please consult the FDA website links below.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: FDA's webpage regarding this variety
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food and Drug Administration
Contact person name:
Jason Dietz
Website:
Physical full address:
5100 Paint Branch Parkway, College Park MD 20740
Phone number:
240-402-2282
Fax number:
Country introduction:

The United States is currently in the process of populating this database. The Food and Drug Administration regulates food and feed (food for humans and animals) from genetically engineered crops in conjunction with the Environmental Protection Agency (EPA). EPA regulates pesticides, including those that are plant incorporated protectants genetically engineered into food crops, to make sure that pesticide residues are safe for human and animal consumption and do not pose unreasonable risks of harm to human health or the environment. FDA In the Federal Register of May 29, 1992 (57 FR 22984), FDA published its "Statement of Policy: Foods Derived from New Plant Varieties" (the 1992 policy). The 1992 policy clarified the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act with respect to human and animal foods derived from new plant varieties and provided guidance to industry on scientific and regulatory issues related to these foods. The 1992 policy applied to all foods derived from all new plant varieties, including varieties that are developed using genetic engineering (also known as recombinant deoxyribonucleic acid (rDNA) technology). In the 1992 policy, FDA recommended that developers consult with FDA about foods from genetically engineered plants under development and developers have routinely done so. In June 1996, FDA provided additional guidance to industry on procedures for these consultations (the consultation procedures). These procedures describe a process in which a developer who intends to commercialize food from a genetically engineered plant meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the genetically engineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food. FDA evaluates the submission and if FDA has questions about the summary provided, it requests clarification from the developer. At the conclusion of the consultation FDA responds to the developer by letter. The approach to the safety assessment of genetically engineered food recommended by FDA during consultations, including data and information evaluated, is consistent with that described in the Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants. EPA The safe use of pesticidal substances is regulated by EPA. Food from a genetically engineered plant that is the subject of a consultation with FDA may contain an introduced pesticidal substance, also known as a plant-incorporated protectant (PIP), that is subject to food (food for humans and animals) safety and environmental review by EPA. PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. Both the PIP protein and its genetic material are regulated by EPA. When assessing the potential risks of PIPs, EPA requires studies examining numerous factors, such as risks to human health, non-target organisms and the environment, potential for gene flow, and insect resistance management plans, if needed. In regulating PIPs, decisions are based on scientific standards and input from academia, industry, other Federal agencies, and the public. Before the first PIP product was registered in 1995, EPA required that PIP products be thoroughly tested against human safety standards before they were used on human food and livestock feed crops. EPA scientists assessed a wide variety of potential effects associated with the use of PIPs, including toxicity, and allergenicity. These potential effects were evaluated in light of the public's potential exposures to these pesticides, taking into account all potential combined sources of the exposure (food, drinking water, etc.) to determine the likelihood that a person exposed at these levels would be predisposed to a health risk. Based on its reviews of the scientific studies and often peer reviews by the Federal Insecticide, Fungicide and Rodenticide Scientific Advisory Panel, EPA determined that these genetically engineered PIP products, when used in accordance with approved label directions and use restrictions, would not pose unreasonable risk to human health and the environment during their time-limited registration.

Useful links
Relevant documents
Stacked events:

Stacked events that are each plant incorporated protectants, as defined by the Environmental Protection Agency, must be registered by the Envriornmental Protection Agency before they can be commercialized.  Food/feed safety asssessment of single events are generally sufficient to ensure the safety of food/feed from stacked events.   

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

Food and Drug Administration ([email protected]); Environmental Protection Agency

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

The NK603 line of maize was developed to allow the use of glyphosate, the active ingredient in the herbicide Roundup®, as a weed control option. NK603 contains a form of the plant enzyme 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) that allows the plant to survive the otherwise lethal application of glyphosate.

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Date of authorization: 21/06/2011
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.): BCH
Summary of the safety assessment (food safety):
Please refer to uploaded document
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: GNBio
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministerio de Ganadería, Agricultura y Pesca
Contact person name:
Alejandra Ferenczi
Website:
Physical full address:
Constituyente 1476, Piso 2, Of. 212B. Montevideo, Uruguay
Phone number:
+598 2 4104155 int 3
Fax number:
Country introduction:

The Uruguayan National Biosafety System (SNB for its acronym in Spanish) includes safety assessments of food end feed, environmental risk assessment, risk management, and risk communication. The National Biosafety Cabinet (GNBio) is the competent authority on biosafety of GMOs. Integrated by: The Minister of Agriculture, MGAP (chair); Minister of Health (MSP); Minister of Economy (MEF); Minister of Environment (MVOTMA); Minister of Foreign Affairs (MRREE); and Minister of Industry (MIEM). This Cabinet is the last responsible to make decisions over a submitted request. It has the authority to define policies to be followed with respect to biosafety in all scopes of GMO application. Other committees of experts and scientists give support to decisions of GNBio through risk analysis of biotechnological products. The Risk Management Commission (CGR) is composed by one delegate of each of the ministries represented within GNBio.  The CGR advises GNBio on GMO biosecurity issues; elaborates reference terms for risk assessments; manages the risk communication participation process; is responsible for follow-up and monitoring of authorized events. The Risk Assessment in Biosecurity (ERB) is composed of experts proposed by the CGR and designated by GNBio among specialists in the different areas of risk assessment. Is responsible for considering, on a case-by-case basis, the potential risks and benefits of each new biotech product; assure case-by-case risk assessment evaluation based on scientific methods; writes an operational plan (pre-report) of risk assessment according to CGR directives; advises CGR based on the results of the analysis of risk assessment, and provides information during the consultation process. The Institutional Articulation Committee (CAI) is a committee of technical experts from nine different national public and research institutions, which analyzes the risk assessment of new events and prepares a technical report. The technical analysis is coordinated by ERB organized in different ad hoc groups of experts. The Ad hoc experts groups are technical-scientific specialists in different areas of knowledge related to the analysis of GMO events like characterization and molecular identification of events, environmental and food safety aspects. 

Useful links
Relevant documents
Stacked events:

GM vegetables from cross-pollinated species, such as corn, with stacked events are not considered as a new product. In the case of GM vegetables from self-pollinated species, such as soybean, are considered as a new product even if all single events stacked have already been approved. However, there is an abbreviated analysis procedure in cases where single events were already analyzed. Stacked events not yet analyzed must have the individual risk assessment report.

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

GNBio office. E-mail: [email protected]; Adress: Constituyente 1476, piso 2, oficina 212B, Montevideo 11200, Uruguay.