| Commodity: |
Soyabean / Soybeans |
| Traits: |
Imidazolinone tolerance |
| Name of product applicant: |
BASF Plant Science GmbH |
| Summary of application: |
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| Date of authorization: |
24/04/2015 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
EU Register of authorised GMOs
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| Summary of the safety assessment (food safety): |
Please see the EU relevant links below.
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
Method for detection: Event specific real-time quantitative PCR based method for genetically modified BPS-CV127-9 soybean
Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003.
Reference material: AOCS 0911-B and AOCS 0911-D accessible via the American Oil Chemists Society.
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 |
E-mail:
Organization/agency name (Full name): European Union
Contact person name: Alexandre Huchelmann
Website:
Physical full address: European Commission B232 04/106 1047 Brussels
Phone number: 3222954092
Fax number:
Country introduction: The process for authorising a new GMO is based on the EU regulation on GM food and feed (1829/2003). An application for authorising food or feed consisting of or made from a GMO must be submitted to the national authorities. The national authority then sends the application to the European Food Safety Agency (EFSA) for a risk assessment. EFSA then makes the application summary available to the public. No matter where in the EU the company applies, EFSA assesses the risks the GMO presents for the environment, human health and animal safety. If the application covers cultivation, EFSA delegates the environmental risk assessment to an EU country which sends EFSA its risk assessment report. After performing the risk assessment, EFSA submits its scientific opinion to the European Commission and to EU countries. The opinion is made available to the public, except for certain confidential aspects. Once EFSA publishes its risk assessment, the public has 30 days to comment on the Commission website for applications under Reg. 1829/2003, and on the Joint Research Centre website on the assessment report of the "lead" EU country for applications under Directive 2001/18. Within 3 months of receiving EFSA's opinion, the Commission grants or refuses the authorisation in a proposal. If it differs from EFSA’s opinion, it must explain why. National representatives approve the Commission’s proposal by qualified majority in: (1) The Standing Committee on the Food Chain and Animal Health if the application was submitted under Reg. 1829/2003; (2) The Regulatory Committee under Directive 2001/18/EC if the application was submitted under Dir. 2001/18. The proposal is adopted if the Committee agrees with it. If there is no opinion, the Commission may summon an Appeal Committee where EU countries can adopt or reject the proposal. If the Appeal Committee makes no decision, the Commission may adopt its proposal. Authorisations are valid for 10 years (renewable). Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
Basf Argentina S.A. |
| Summary of application: |
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| Date of authorization: |
07/03/2013 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
• Inheritance studies conducted indicated that Mendelian segregation exists.
• New expression proteins in grain are expressed in low levels.
• It is substantially equivalent to its non-transgenic counterpart except for small changes in fat, Ca, Mg, beta tocopherol and daidzein that do not imply any risk for consumption, and can be considered as nutritious as conventional soy.
• No evidence of similarity or homology was found with known toxic proteins.
• There is no evidence of expression of known allergenic substances for the proteins expressed in the event.
• The feeding study carried out with broiler chickens showed that there are no adverse dietary effects.
It is concluded that the event CV127 is equivalent to its conventional counterpart, therefore, it is as safe and not less nutritious than conventional commercial soybean. |
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Decision Document - Safety Assessment Summary
GMO approvals for food/feed
Food and feed safety asssessment of GMOs - Argentina
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| Authorization expiration date (a blank field means there is no expiration date) |
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E-mail:
Organization/agency name (Full name): Ministerio de Agroindustria
Contact person name: Andrés Maggi
Website:
Physical full address: Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number: 54 11 5222 5986
Fax number:
Country introduction: In Argentina, the food and feed risk assessment process of transformation events, as the result of modern biotechnology, is carried out by the National Service for Agrifood Health and Quality (Senasa). The General Office of Biotechnology, is the area responsible for carrying out this task. It has an specific professional team and the advise of a Technical Advisory Committee composed of experts from several scientific disciplines representing different sectors involved in the production, industrialization, consumption, research and development of genetically modified organisms. Useful links
Relevant documents
Stacked events: Stacked events with all single events approved, are assessed as a new event, but with much less requirements, always on a case-by-case basis. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: National Service for Agrifood Health and Quality (Senasa)
https://www.argentina.gob.ar/senasa
https://www.argentina.gob.ar/senasa/programas-sanitarios/biotecnologia
| Name of product applicant: |
BASF Plant Science Company GmbH |
| Summary of application: |
A genetically modified (GM) soybean line BPS-CV127-9, hereafter referred to as CV127, has been developed that is tolerant to the imidazolinone class of herbicides.
Tolerance to imidazolinone herbicides in soybean line CV127 is achieved through expression of an imidazolinone-tolerant acetohydroxyacid synthase (AHAS)1 catalytic subunit encoded by the csr1-2 gene derived from the plant Arabidopsis thaliana. AHAS, which catalyses the first step in the biosynthesis of the branched-chain amino acids (valine, leucine, and isoleucine), is the target of several classes of structurally unrelated herbicides, including the imidazolinones, the sulfonylcarboxamides, the sulfonylureas and the triazolopyrimidines.
The AHAS catalytic subunit combines with a smaller regulatory subunit to form the AHAS enzyme complex. The regulatory subunit is necessary for full enzymatic activity and also for end-product feedback inhibition by the branched chain amino acids. The A. thaliana AHAS catalytic subunit expressed in soybean line CV127 has altered herbicide binding properties such that imidazolinone herbicides are unable to bind, and therefore inhibit, its activity. It is able to combine with the endogenous soybean regulatory subunit to form an imidazolinone-tolerant AHAS enzyme which is able to function in the presence of imidazolinone herbicides. |
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| Date of authorization: |
12/07/2012 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
OECD BioTrack Product Database
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| 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: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Application A1064 - Food derived from Herbicide-tolerant Soybean Line CV127
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E-mail:
Organization/agency name (Full name): Food Standards Australia New Zealand
Contact person name: Gaya Subramaniam
Website:
Physical full address: Level 4, 15 Lancaster Place, Majura Park ACT 2609, Australia
Phone number: +61 2 6271 2222
Fax number: +61 2 6271 2278
Country introduction: Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 115 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 10 staff) is located in Wellington on the North Island. Useful links
Relevant documents
Stacked events: FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)
No separate approval or safety assessment is necessary for foods derived from a stacked GM line that is the result of traditional breeding between a number of GM parent lines for which food has already been approved. Food from the parent lines must be listed in the Australia New Zealand Food Standards Code. The parent lines may contain any number of different genes. If food from any of the GM parent lines has not been approved, then a full pre-market safety assessment of food from the stacked line must be undertaken.
No separate approval is required for food derived from a line that is the product of a GM line, for which food has been approved, crossed traditionally with a non-GM line.
Where a single line containing a number of genes has been produced as a result of direct gene technology methods (rather than traditional crossing) then food derived from the line must undergo a full pre-market safety assessment before approval can be given Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)
| Name of product applicant: |
Embrapa Soja and BASF S.A |
| Summary of application: |
This GMOs is a genetically modified soybean, tolerant to herbicides of chemical class imidazolinones, Soybean CV127, Event BPS-CV127-9, for the purpose of its release into the environment, marketing, consumption and any other activity related to this GMO and derived progenies. The event has gene csr1-2 that codes for enzyme acetohydroxyacid-synthase (AHAS), which acts in the first phase of branched chain amino acid (valine, leucine and isoleucine) synthesis in plants and microorganisms. Inhibition of AHAS enzyme activity by imidazolinone binding causes cell death by the inability of cells to produce these amino acids, fundamental to synthesis of proteins and other derived amino acids that are fundamental for other metabolic routes. The gene codes for a single transit peptide that directs the translation product to plastids, where synthesis of such amino acids takes place. Soybean CV127 was the result of a transformation by means of biobalistics |
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| Date of authorization: |
10/12/2009 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
Center For environmental Risk Assessment
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| Summary of the safety assessment (food safety): |
The gene codes for a single transit peptide that directs the translation product to plastids, where synthesis of such amino acids takes place. Soybean CV127 was the result of a transformation by means of biobalistics. The following biochemical characteristics related to protein AHAS were assayed:
(i) molecular mass;
(ii) immunoreactivity;
(iii) enzymatic activity and its inhibition through feedback by product amino acids;
(iv) glycosilation;
(v) determination of peptide amino acids sequences derived from the purified protein.
Preparations of the recombinant protein were obtained from young leaves of Soybean CV127 cultivated under field conditions. All results indicated full equivalence of the recombinant protein derived from Soybean CV127 to the same protein produced by a heterolog system.
Environmental safety of Soybean CV127 was comparatively analyzed with its non-GM isoline and two other conventional varieties of soybean in essays held in different places that represent soybean farming in Brazil. The following phenotypic, agronomic and ecologic characteristics were assayed:
(i) seed germination rate;
(ii) seed vigor;
(iii) comparative follow-up along time of main development phases;
(iv) height of plants;
(v) leaf-dropping;
(vi) susceptibility of diseases and field pest-insects;
(vii) grain yield;
(viii) insect population in plants and soil (microfauna);
(ix) populations of parasitic and free-living nematodes;
(x) soil microbial biomass; and
(xi) relevant factors for nitrogen fixation to soil by Bradyrhizobium symbiosis.
All data obtained in this study demonstrated that Soybean CV127 is equivalent to its non-GM equivalent and two soybean varieties used as controls. Results of the study on number, germination patterns and morphologic and microspore (pollen) characteristics, as well as germination characteristics, indicated that there were no significant differences between the transgenic variety and its non-GM isoline. Equally, there was no difference recorded in seed dormancy and likelihood of emergence of long-term reproduction structures, which are practically non-existing in soybean. Additionally, studies were submitted supporting that the GM soybean analyzed has no difference from its non-GM isoline regarding ability to extract or introduce substances into the soil, equaling, therefore, the potential impact to environment caused by conventional soybean. Biodegradability of plant soybean tissues in soil after harvest was assayed, as well as that of protein AHAS, and the result was that GM and non-GM plants behave equally. Regarding aspects of human and animal feeding safety assessment and harmful effects to the environment, data submitted lead to an understanding that there were no pleiotropic and epistatic effects caused by inserted genes in the course of at least seventeen generations of soybean containing the transgenic construct. Besides, no allergenic potential was detected in the protein introduced, and studies demonstrated its digestibility in simulated gastric fluid and in guinea-pigs. Results submitted confirm the transgenic variety risk level as equivalent to that of non-transgenic ones regarding soil microbiota, non-target vertebrate and invertebrate animals and other plants. In conclusion, alimentary safety of Soybean CV127 is rooted in the transgene nature and remaining exogenous DNA sequences introduced in the plant, its behavior, and the plant proliferation environment that is restricted to tillage of small, middle and large extensions. CTNBio analyzed the reports submitted by applicants in addition to independent scientific literature.
TECHNICAL OPINION
I GMO identification:
GMO Designation: Soybean CV127
Applicant: BASF S.A. and Embrapa Soja
Species: Glycine max (L.) Merr
Inserted Characteristics: Tolerance to herbicide of the imidazolinone chemical class
Insertion Method: Soybean CV127, classified as Risk Class I, was obtained by transformation through biobalistics of a commercial variety of Conquista soybean, using a plasmid Pac321 DNA fragment of about 6.2 kb, containing the expression cassette of Arabidopsis thaliana gene csr1-2 (granting tolerance to herbicides of the imidazolinone chemical class) and the complete sequence of protein AsSEC61y gamma subunit.
Prospective Use: Free registration, use, essays, tests, sowing, transport, storage, marketing, consumption, release and discarding and any other activities related to this GMO.
II. General Information
Applicants developed a soybean variety tolerant to herbicides of imidazolinone chemical class, an event styled BPS-CV127-9, “Soybean CV127” hereinafter. This soybean derives from a single transformation event obtained by biobalistic introduction of Arabidopsis thaliana genes csr1-2 with its native promoter and untranslated native region (UTR) 3’. Gene csr1-2 codes a major subunit of acetohydroxiacid synthase that grants tolerance to imidazolinone chemical class herbicides. A fragment of plasmid pAC321 DNA, containing the expression cassette, was used to modify the original apical meristheme tissue embryo axis of a soybean seed belonging to Conquista, a Brazilian variety most used by soybean farmers, widely adaptable to Brazilian regions. The resulting phenotype is a soybean that enables farmers to use imidazolinone group herbicide while causing no harm to the plant. Gene csr1-2 codes for a single polypeptide, formed by 670 amino acids including protein AtAHASL (or AHAS), the Arabidopsis thaliana cytoplast transit peptide (CTP), responsible for directing the protein to chloroplasts (where branched chain amino acids biosynthesis takes place). During the transport phase of protein ArAHASL to the chloroplast, the transit peptide is removed to produce active enzyme AHAS. The enzyme grants tolerance to imidazolinone group herbicide given by a punctual mutation that results in substituting one asparagine for the serine amino acid in position 653. Enzyme AHAS catalytic subunit has a property to link with herbicides while keeping the normal plant biosynthetic function (Pang et al., 2002).
III. Aspects Related to Human and Animal Health
The weed control by imidazolinones results from inhibition of acetohydroxyacid synthase enzyme in plants, which acts in the valine, leukine and isoleucine amino acid synthesis route. They act in both mono- and dicotiledoneae (Shaner and Mallipudi, 1991). The initial transformer came from buds of meristhem tissues with plant regeneration while exposed to the herbicide. Reselection occurred up to the F4 generation. Molecular follow-up monitoring the inserted gene single copy stability and agronomic performance. Development followed with retrocrossing between T4 and Conquista soybean that gave way to the new line (603) conducted up to F8, once more under agronomic and molecular monitoring, followed by a new crossing with the Conquista variety to obtain the 127 line (generation F7), the origin of Soybean CV127.
Genetic maps detailing the plasmid and insert were submitted by applicants. The Arabidopsis thaliana DNA sequences were presented, together with the protein amino acid sequence. Southern blots demonstrated existence of a single insertion event and pointed out to the location of several diagnostic probes evidencing an absence of elements from the vector used (such as the ampicillin antibiotic resistance gene). The analysis also evidenced absence of 501 pb open reading frame (ORF) expression generated by duplicating 376 base pairs of a sequence part that is the coder for gene csr1-2, directly before the 3’ integration point.
Inserted gene csr1-2 codifies for a 670 amino acid protein that has a transit peptide to the chloroplast, which is removed after translocation. The gene, besides the mutation granting resistance to the herbicide, carries mutation R272K, with no recognized phenotype. The Arabidopsis thaliana gene still not recorded, AtSEC61-gamma, appears as part of its promoter upstream gene csr1-2. It codes for an endoplasmatic reticulum transport short protein (69 amino acids), ubiquitous in plants and other eucaryotes. It expression was assessed in soybean and its transcription was found in very low levels in leaf tissue, while remaining the protein undetectable in leaves and kernels within the detection levels of the Western blot method (5 and 15 ppb, respectively). Self-specific PCR tests were developed for identification and verification of Soybean CV127.
Besides, Soybean CV127 and controls kernels collected in four locations within Brazil were processed to produce the most used soybean fractions in human and animal food: refined oil, soybean meal and protein fraction. Protein AHAS expression level was assayed in each of the processed fractions. Results confirmed that protein AHAS is present in very low levels, though effective in granting resistance to the herbicide.
Genetic inheritance pattern was tested and showed to be typically Mendelian. No pleiotropic or epistatic effects resulting from insertion in Soybean CV127 were detected.
Protein AHAS is expressed in soybean in small amounts. The assay was conducted with Brazilian samples, coming from seven field essays on the 2006 and 2007 crops, and from six essays on the 2007 late summer crop. ELISA tests revealed quantities lower than one part per million (dry tissue). The figures range from about 500 ng per gram (leaves) to about 15 ng per gram (kernels) considering dry weight (DW). In kernel processed fractions (oil, flour and isolated protein) detection of the protein was not possible. Applicants submitted additional information related to materials and methods for determining concentration of proteins AHAS and SEC61(gamma) in Soybean CV127 tissues, complying with a CTNBio request. The document describes in detail the procedures employed, using two biologic replicas for experiment, each one generating three technical replicas for the ELISA tests. A total of thirteen charts display the quantitative data of analyses conducted with the different samples that were collected. Protein AHAS was analyzed at the applicant laboratory in Brazil and tests for quantification of SEC61(gamma) protein were conducted in Germany.
Allergenicity was tested in silico by comparison with a FARRP v. 8.0 database (containing 1,313 proteins) using two different methods of screening. The results failed to reveal any allergenic potential. High digestibility and instability to heath (60ºC) exhibited by both the optimized and feral protein are characteristics of non-allergenic proteins. Soybean has 33 known natural allergenic proteins and the patterns of such proteins in Soybean CV127 and Conquista were similar. Besides, the proteins were verified to be non-glycosylated, a positive fact since proteins with a potential to cause allergies are in general glycosylated.
The BLASTP tool compared the csr1-2 protein sequence with the remaining ones deposited with GenBank and there was no significant homology with any toxic protein of a reference database. Acute toxicity tests in mice used a 2.62g/kg of body weight dose. There was no clinical sign of toxicity or effect on weight of animals treated. The weight of organs examined fourteen days after gavage (brain, spleen, kidney, liver and heart) was similar to the ones measured in control groups. Innocuity of the dose represents a safety factor above 5 x 108 regarding the human daily average consumption in Brazil, assuming that the protein is present in all soybeans consumed. A recent revision by the EFSA (Alink et al., 2008) on animal tests to assess safety of foods derived from genetically modified plants concluded that there is no biologically relevant difference, within the parameters of the test, in animals used to demonstrate food safety when fed with genetically modified plants.
Digestibility of protein AHAS in gastric and intestinal fluids was fast (30 seconds). About seventy components were examined to assay centesimal composition, proteins, lipids, ashes, carbohydrates, calories, alimentary fibers, humidity, post-treatment fibers, amino acids, fat acids, minerals, vitamins, isoflavones, phospholipids, and antinutrients. Herbicide-treated Soybean CV127 was compared to assess any important alteration on the above parameters. Analyses included kernels, fodder and processed fraction of soybean (oil, soybean meal and concentrated protein). The data indicated equivalence in composition among Soybean CV127, Conquista soybean and two other non-transgenic commercial varieties currently marketed. This equivalence was also confirmed in feeding animals with broiler chickens (576 individuals) fed on a balanced diet (42 days) in treatments containing meals of two commercial soybeans and isoline. Results were equivalent in body weight gain, ration consumption, clinical signs, mortality, behavior, microscopic pathology, hematological and biochemical parameters, demonstrating nutritional equivalence. There was no evidence of adverse effects on animals fed on Soybean CV127. The studies conducted with rats failed to record any clinical sign of toxicity and there was no significant difference in body weight and average absolute weight on different organs selected (brain, spleen, kidneys, liver and heart) when compared with the control group. Besides no adverse effect or lesion related to the treatment was recorded in the study, ratifying the atoxic nature of protein AHAS in mammals.
Although the request for this particular soybean is the first in the world, varieties of imidazolinones chemical class herbicide resistant plants, expressing enzyme AHASL were obtained by induced or spontaneous mutagenesis, with the same substitution for amino acid S653N in corn, canola, rice, lentil and sunflower. The varieties are commercial known as Clearfield and are already farmed in several countries, including Brazil, for over fifteen years.
For the foregoing, there are no experimental evidences that Soybean CV127 presents any toxicological or nutritional risk for humans or animals, when compared with conventional soybean varieties. Taking into account internationally accepted criteria in the process of analyzing risk in genetically modified raw materials, based on the concept of substantial equivalence, the modification introduced by genetic manipulation, inserting a gene of a non-toxic or invasive model plant, such as Arabidopsis thaliana, simply granted the soybean resistance to imidazolinone class herbicides.
IV. Environmental Aspects
Varieties of herbicide resistant plants have been obtained by induced or spontaneous mutagenesis in corn, canola, lentil and sunflower. Specifically for the imidazolinone chemical class herbicides, this approach was already used in cultivated varieties in different countries with a technology named Clearfield. For the sake of alimentary and agronomic safety strategy, existence of herbicide resistant varieties with different action mechanisms is desirable so that a farmer may have tools for managing resistant invading plants whenever they appear as a result of the applied pressure (Fedoroff and Brown, 2004). Herbicide tolerant varieties have contributed in widening direct sowing cultivars, a highly beneficial practice to the environment. Attempts to obtain the imidazolinone resistance in soybeans through chemically induced mutation resulted in partial resistance only, which was useless in the fields. The mutagenesis process results in global alterations of gene expression that are higher than those obtained by genetic engineering, as shown in rice by Batista et al. (2008). The fact is an additional assurance of safety provided by directed genetic manipulation. The interested companies submitted a well grounded application with a complete molecular and chemical characterization of the insert and its products.
Results of studies on number, germination pattern and morphological characterization of microspores (pollen), as well as germination characteristics indicate absence of significant differences between the plant transgenic and non-transgenic isolines. Equally, there was no recorded difference regarding seed dormancy or likelihood of establishment of long term reproduction structures that, on soybean, are practically nihil.
Documents submitted by applicants discuss aspects of a possible horizontal transfer and consequences of the event. The conclusions, supported by competent bibliographic references, concur to the fact that, besides being unlikely, no relevant consequence will take place with horizontal transfer of the transgene to the microbiota inhabitants.
A number of studies were submitted in this analysis that support the assertion that the GM soybean analyzed is no different from its non-GM isoline regarding ability to extract or introduce substances in soil, equaling, therefore, the potential impact to the environment under this viewpoint. Biodegradability of soybean plant tissues in soil was assessed after harvest, as well as that of the AHAS protein, providing equal results for modified and conventional plants.
Quantitative and qualitative results of Soybean CV127 agronomic behavior were equivalent to conventional soybean plants either in the present or absence of imidazolinone class herbicides during two harvest periods in different places of the country. The aspects assessed were: seed size and germination, vigor of plants, initial and final stand, green stem, plant height, dehiscence, leaf-dropping, days to flourish and maturing, grain yield and seed quality. The conclusion was that Soybean CV127 plants and derivatives showed agronomic properties compatible with those of conventional plants of the farmed soybean in Brazil.
All studies related to assessments of human and animal safety and adverse effects to the environment clearly lead to the understanding that there was not and are not pleiotropic and epistatic effects of the inserted genes along at least seventeen generations of soybean containing the genetic construct. Bibliographic data and results submitted confirmed the transgenic variety risk level as being equivalent to that of non-transgenic ones regarding soil microflora, non-target vertebrate and invertebrate animals, as well as other plants.
Tests were additionally conducted to assess incidence of soybean foliar diseases, based on statistic studies of foliar area damage. In no place and for no disease any significant difference between Soybean CV127 and the isoline was recorded, demonstrating that insertion of gene csr1-2 failed to affect susceptibility to diseases. Studies were also conducted in seven places during the 2006-2007 harvest and in six places during the 2007 late summer harvest to assess Soybean CV127 effects to nematodes, with a number of treatments, in both presence and absence of some herbicides. Data enabled a conclusion that, independently from the herbicide, the soybean fails to cause impact in free-living nematode populations and to contribute for an increased number of parasite nematodes in the plant.
Studies aimed at assessing incidence of predators, number of insects of orders Coleoptera, Lepidoptera and Hemiptera detected in Soybean CV127 failed to record statistically significant differences in plants of the isoline or of the conventional soybeans in the four moments of the sampling. Besides, the damage caused by insect feeding among treatments and among essay locations was minimal, no differences recorded among treatments. Resistance to insect damage and effect of Soybean CV127 in pest insect populations in the fields were no different from the ones found in the isoline and varieties of conventional soybean.
Assessment of symbiontic organisms was conducted in seven essays during the 2006-2007 harvest and six during the 2007 late summer harvest. There were no significant differences in populations, and figures were compatible to the ones commonly found in experiments with bradyrhizobium-inoculated soybean. A good nodulation was recorded in all places and treatments. Regarding the remaining microorganisms, especially those of the microbial carbon biomass (MCB) there was no statistically significant differences recorded among treatments in any place and for different phases of plant development. Analysis of variance was conducted for all places and no significant differences were recorded among treatments. Equally, for the microbial nitrogen biomass, no statistically significant difference was found among treatments.
The technique of rDNA profiles, also used in 2006-2007 harvest and 2007 late summer harvest samples, was used to qualitative assessment of the soil microbial community. The results showed that there were no effects caused by the different treatments or by application of different herbicides in the soil microbial community qualitative characteristics.
Regarding soil microfauna, population and diversity were assayed in seven places during the 2006-2007 harvest and in six places during the late summer 2007 harvest. Results of the impact assessment in cultivation of herbicide-treated genetically modified soybean showed an absence of changes in populations and community diversity of soil macro-organisms when compared to the isoline and to commercial varieties used as standards.
Regarding assessment of soybean dispersion mechanisms in the air, water and soil, insertion of the csr1-2 gene failed to change any botanical trait of the plant. Soybean has no natural dispersion mechanisms for its propagation and reproduction structures in air, water and soil; however it may be disseminated by insects, agricultural tools and man. Soybean is predominantly self-fertile. In case of pollen dissemination by insects, it may take place by hymenopters, though in significantly low rates (Beard and Knoles, 1971; Erickson et al., 1978). Thus, Soybean CV127 is botanically comparable to its isoline.
Regarding horizontal gene transfer from plants to bacterium, followed by functional expression, it involves an extremely complex process that demands successive phases with very low probability of occurrence. As the first phase, the gene must be available intact in the environment, but this is extremely improbable in view of the endonuclease action of the plant itself. Besides, the quantity of the insert is significantly smaller when compared to the plant genomic DNA. Once made available in intact form, the gene must be captured by an able microorganism, yet not all microorganisms may be transformed in a laboratory facility that uses optimized conditions not found in nature. Studies concluded that after different transformation essays, the quantity of bacterium in the soil and rhizosphere that are naturally transformable is extremely low (Richter and Smalla, 2007). After the events have taken place, besides containing the complete gene coding sequence, the DNA fragment must contain, in addition, sequences that are homologue to the genome of the receiving organism to facilitate a stable integration to the fragment by homologue recombination. Finally, the gene must contain its appropriate sequences for expression; however in this case and in most transformation events, cassettes are constructed with promoters that do not act as transition promoters in bacteria and fungi, even facing the possibility of stable integration to the host genome. Thus, transference of gene csr1-2 features a very poor likelihood, under the demonstrated conditions, as shown in other studies (Miki and McHugh, 2004; Van de Eede et al., 2004).
V. Restrictions to the use of the GMO and its derivatives
As established by Article 1 of Law nº 11,460, of March 21, 2007 “research and cultivation of genetically modified organisms may not be conducted in indigenous lands and areas of conservation units.”
Studies submitted by applicants demonstrated lack of significant difference between genetically modified soybean and its conventional isoline regarding agronomic characteristics, reproduction mode, dissemination and survival ability. All evidence submitted in the proceeding and bibliographic references confirm the risk level or the transgenic variety as being equivalent to that of the non-transgenic varieties regarding soil microbiota, as well as other plants and human and animal health. Thus, cultivation and consumption of Soybean CV127 are not a potential cause of significant degradation to the environment or risks to human and animal health. For these reasons, there are no restrictions to the use of such soybean and its derivatives, except in places mentioned in Law nº 11,460, of March 21, 2007.
Soybean is an exotic species to Brazil and there are no feral kindred able to cross and originate descendants. Gene flow between soybean plants is already studied in tropical conditions. Soybean is an autogamous species, with full flowers, and crossed pollination rates of 0.5% to 1% have been recorded according to the type and place of the cultivar, being eight meters the maximum distance to enable gene flow.
After ten years of use in different countries, no problem has been recorded to human and animal health or to the environment that could be traced to transgenic soybeans.
It shall be emphasized that lack of negative effects in transgenic plant farming is not a guaranty that such effects may not occur. Zero risk and absolute safety do not exist in the biologic world, although there is a mass of reliable scientific information of use of transgenic varieties in agriculture. Therefore, applicant shall conduct post-commercial release monitoring under CTNBio Ruling Resolution nº 3 and according to this Technical Opinion.
The monitoring plan includes assessment of GM and non-GM plants in regions that are representative in soybean farming, such as the States of Rio Grande do Sul, Paraná, Minas Gerais, Mato Grosso e Bahia, for five consecutive years and in areas not below three hectares in each location. The following indicators shall be assessed:
(i) Change in composition of species in the infesting community (diasporas bank and invading plants);
(ii) effects coming from herbicide resistance development in invading plants;
(iii) study of nutritional status and phytosanity;
(iv) changes in soil physical and chemical characteristics;
(v) herbicide degraders; and
(vi) studies of impacts to human and animal health.
Each such assessment was adequately described in the proceeding.
VI. Considerations on particulars of different regions of the country (background information to monitoring agencies).
As established by Article 1 of Law nº 11,460, of March 21, 2007 “research and cultivation of genetically modified organisms may not be conducted in indigenous lands and areas of conservation units.”
VII. Conclusion
Considering that soybean is a well characterized plant with a solid history of safety for human consumption and the genes introduced into this variety code for proteins that are ubiquitous in nature.
Considering that centesimal composition data fail to point out significant differences between genetically modified conventional varieties, suggesting their nutritional equivalence.
Whereas:
1. AHAS protein is present in plants and microorganisms and in several natural mutants presenting tolerance to the imidazolinones class herbicides. Therefore, humans and animals have a long history of use of this protein in food;
2. Several imidazolinone tolerant that produce AHAS enzyme with the same substitution at position 653 (substitution of asparagine for serine), present in Soybean CV127, have been marketed under the brand name Clearfield® and farmed for several years without adversely affecting human and animal health and the environment;
3. Molecular analysis of Soybean CV127 evidenced that integrity and stability of the insert was maintained;
4. Segregation analysis and genetic inheritance pattern are stable along successive generations; and
5. Agronomic and efficacy assessments of Soybean CV127 indicated that the insertion failed to lead to expression of any other characteristic but the expected one, tolerance to herbicides of the imidazolinones chemical class.
For the foregoing and considering internationally accepted criteria in the process of risk analysis of genetically modified raw materials one may conclude that Soybean CV127 is as safe as its conventional equivalents. In the context of the competences attributed to CTNBio under Article 14 of Law nº 11,105/05, CTNBio considered that the request complies with the rules and laws in effect aimed at securing biosafety of the environment, agriculture, human and animal health, and reached a conclusion that Soybean CV127 is substantially equivalent to conventional soybean and its consumption is equally safe for human and animal consumption. Regarding the environment, CTNBio concluded that Soybean CV127 is not a potential cause of significant degradation to the environment, maintaining with the biota a relation identical to conventional soybean.
CTNBio holds this activity is not a potential cause of significant degradation to the environment and of harm to human and animal health. Restrictions to the use of the GMO studied and its derivatives are conditioned to the provisions of Law nº 11,460, of March 21, 2007.
CTNBio analysis considered the opinions issued by the Commission Members; ad hoc consultants; documents submitted by applicant to CTNBio Office of the Executive Secretary; results of planned releases into the environment; lectures, texts. Independent scientific studies and publications submitted by applicant and conducted by third parties were also taken into account.
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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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Not Applicable |
E-mail:
Organization/agency name (Full name): National Biosafety Technical Commission
Contact person name: Paulo Augusto Viana Barroso
Website:
Physical full address: SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number: 556120335087
Fax number:
Country introduction: Brazil had the first biosafety law approved in 1995. After the identification of the need to improve the biosafety system of Brazilian genetically modified organisms, a new law was published. The Law 11.105 / 05 establishes a technical committee dedicated to the analysis of the safety aspects of genetically modified organisms and a council of ministers that is dedicated to the analysis of the socioeconomic aspects of the commercial release of genetically modified organisms. In this context, Brazil already has several commercial products that involve genetically modified organisms (plants, human and veterinary vaccines, microorganisms for fuel production) and products derived from new genetic modification techniques. Useful links
Relevant documents
Stacked events: At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Dr. Paulo Augusto Viana Barroso (President of national Biosafety Commission)
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BASF Canada Inc. |
| Summary of application: |
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| Date of authorization: |
31/10/2012 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
BioTrack Product Database
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| Summary of the safety assessment (food safety): |
Please see decision document weblinks |
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Novel Foods Decision Document
Novel Feeds Decision Document
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E-mail:
Organization/agency name (Full name): Health Canada
Contact person name: Neil Strand
Website:
Physical full address: 251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number: 613-946-1317
Fax number:
Country introduction: Federal responsibility for the regulations dealing with foods sold in Canada, including novel foods, is shared by Health Canada and the Canadian Food Inspection Agency (CFIA). Health Canada is responsible for establishing standards and policies governing the safety and nutritional quality of foods and developing labelling policies related to health and nutrition. The CFIA develops standards related to the packaging, labelling and advertising of foods, and handles all inspection and enforcement duties. The CFIA also has responsibility for the regulation of seeds, veterinary biologics, fertilizers and livestock feeds. More specifically, CFIA is responsible for the regulations and guidelines dealing with cultivating plants with novel traits and dealing with livestock feeds and for conducting the respective safety assessments, whereas Health Canada is responsible for the regulations and guidelines pertaining to novel foods and for conducting safety assessments of novel foods.
The mechanism by which Health Canada controls the sale of novel foods in Canada is the mandatory pre-market notification requirement as set out in Division 28 of Part B of the Food and Drug Regulations.
Manufacturers or importers are required under these regulations to submit information to Health Canada regarding the product in question so that a determination can be made with respect to the product's safety prior to sale. The safety criteria for the assessment of novel foods outlined in the current guidance document (i.e. Canadian Guidelines for the Safety Assessment of Novel Foods) were derived from internationally established scientific principles and guidelines developed through the work of the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organisation (FAO), World Health Organisation (WHO) and the Codex Alimentarius Commission. These guidelines provide for both the rigour and the flexibility required to determine the need for notification and to conduct the safety assessment of the broad range of food products being developed. This flexibility is needed to allow novel foods and food products to be assessed on a case-by-case basis and to take into consideration future scientific advances. Useful links
Relevant documents
Stacked events: Food: Consistent with the definition of "novel food" in Division 28 of the Food and Drug Regulations, the progeny derived from the conventional breeding of approved genetically modified plants (one or both parents are genetically modified) would not be classified as a novel food unless some form of novelty was introduced into such progeny as a result of the cross, hence triggering the requirement for pre-market notification under Division 28. For example, notification may be required for modifications observed in the progeny that result in a change of existing characteristics of the plant that places those characteristics outside of the accepted range, or, that introduce new characteristics not previously observed in that plant (e.g. a major change has occurred in the expression levels of traits when stacked). In addition, the use of a wild species (interspecific cross) not having a history of safe use in the food supply in the development of a new plant line may also require notification to Health Canada. However, molecular stacks are considered new events and are considered to be notifiable as per Division 28.
Feed: Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Neil Strand, Section Head of Novel Foods
| Name of product applicant: |
BASF |
| Summary of application: |
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| Date of authorization: |
26/01/2012 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
Based on the risk assessment, it can be concluded that the event shows the same risks as its conventional counterpart. Therefore the National Technical Biosafety Committee for GMO use exclusively in Health and human consumption (CTNSalud) recommends its authorization. |
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E-mail:
Organization/agency name (Full name): Ministerio de salud y proteccion social
Contact person name: Daniel Rubio
Website:
Physical full address: Carrera 13 No. 32- 76 piso 12, Bogotá
Phone number: 330 5000 ext 1256
Fax number:
Country introduction: The 4525 decree of 2005, established the Ministry of Health and Social Protection as the competent authority for GMO for health and food purposes and creates the National Biosafety Technical Committee for GMO's used in health and food purposes (CTNSalud).
The CTNSalud is composed by the Ministry of Health and Social Protection, the National Food and Drug Surveillance Institute (INVIMA) and the Technology and Innovation Administrative Department (COLCIENCIAS). This committee is responsible for the assesment of risk assessments; to inquire for any additional information; assessment of any measurements in accordance to the Cartagena Protocol; and the recommendation for the authorization of GMO for health or food purposes. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
BASF Japan K.K. |
| Summary of application: |
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| Date of authorization: |
04/12/2012 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
OECD BioTrack Product Database
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| Summary of the safety assessment (food safety): |
Please see the links below (in Japanese). |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Food safety assessment performed by Food Safety Commission of Japan (in Japanese), Food
Food safety assessment performed by Food Safety Commission of Japan (in Japanese), Feed
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E-mail:
Organization/agency name (Full name): Food Safety Commission Secretariat,Cabinet Office,
Contact person name: Kojiro Yokonuma
Website:
Physical full address: Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number: 81 3 6234 1122
Fax number: 81 3 3584 7392
Country introduction: Safety assessments of GM foods are mandatory under the Food Sanitation Law in Japan. The Ministry of Health, Labour, and Welfare (MHLW) legally imposes safety assessments of GM foods so that those that have not undergone safety assessments would not be distributed in the country. MHLW receives application and requests the Food Safety COmmission of Japan (FSCJ) to evaluate the safety of GM foods in terms of human health. Safety assessments are carried out by FSCJ.
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
BASF (Malaysia) Sdn. Bhd. |
| Summary of application: |
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| Date of authorization: |
23/10/2013 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
Department of Biosafety Malaysia
CBD Biosafety Clearing House
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| Summary of the safety assessment (food safety): |
Please refer to uploaded document. |
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E-mail:
Organization/agency name (Full name): Department of Biosafety Malaysia
Contact person name: Dr. Anita Anthonysamy
Website:
Physical full address: Department of Biosafety,
Ministry of Natural Resources, Environment and Climate Change
Level 4, Block F11, Complex F
Lebuh Perdana Timur, Precinct 1
62000 Putrajaya, Malaysia
Phone number: +60380917322
Fax number: +60380917371
Country introduction: GM food safety assessment is a requirement by law under the Biosafety Act 2007 in Malaysia. The National Biosafety Board reviews and makes decisions on events based on a scientific/technical risk assessment, policy considerations as well as public input. The decisions and its related documents made are publicly available through the Malaysian Department of Biosafety Website and the Convention of Biological Diversity Biosafety Clearing House. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Department of Biosafety, Ministry of Natural Resources, Environment and Climate Change Level 4, Block F11, Complex F Lebuh Perdana Timur, Precinct 1 62000 Putrajaya, Malaysia. Email: [email protected]. Url: www. biosafety.gov.my
Food Safety and Quality Division, Ministry of Health, Level 4, Menara Prisma, No. 26, Persiaran Perdana, Putrajaya, Malaysia, 62675. Phone: +603 88850797 Fax: +603 88850790 Email: [email protected]
| Name of product applicant: |
BASF Mexicana, S.A. de C.V. |
| Summary of application: |
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| Date of authorization: |
02/05/2011 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
UI OECD: BPS-CV127-9
During the risk assessment of this GMO based on existing knowledge to date, no toxic or allergic effects neither substantial nutritional changes are observed. The event is as safe as its conventional counterpart.
For more detail please find attached the risk assessment summary in this page.
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E-mail:
Organization/agency name (Full name): CIBIOGEM
Contact person name: Dra. Consuelo López López
Website:
Physical full address: San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number: +52 (55) 53227700
Fax number:
Country introduction: México ha buscado garantizar la inocuidad de los productos biotecnológicos para el uso y consumo de su población.
Desde 1984 el artículo 282 bis 1 de la Ley General de Salud, contempló que la Secretaría de Salud debería regular aquellos productos biotecnológicos, o sus derivados, destinados al uso o consumo humano.
En un inicio, con fundamento en este artículo, la Secretaria de Salud evaluó la inocuidad alimentaria de productos biotecnológicos, para su comercialización con fines de uso o consumo humano. A partir de 2005, con la entrada en vigor de la Ley de Bioseguridad de Organismos Genéticamente Modificados (LBOGM), se realizó la adecuación de la regulación para dar lugar a la Autorización que es el acto administrativo mediante el cual la Secretaría de Salud, a través de la Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), autoriza Organismos Genéticamente Modificados (OGMs), a efecto de que se pueda realizar su comercialización, así como su utilización con finalidades de Salud Pública o de Biorremediación.
Las facultades que corresponden a la Secretaría de Salud se estipulan en el artículo 16 de la LBOGM y lo relativo a la Autorizaciones se describe en los artículos 91 al 98 de dicha Ley.
Quienes pretendan obtener una Autorización para Comercialización e Importación de OGMs deben presentar ante COFEPRIS, una solicitud por escrito acompañada de la información a que se refiere los artículos 23 al 32 del Reglamento de la Ley de Bioseguridad de OGMs.
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf
Courtesy translation
Mexico has sought to guarantee the safety of biotechnological products the use and consumption of its population. Since 1984, article 282 bis 1 from the General Law of Health, considered that the Secretary of Health should regulate those biotechnological products, or their derivatives, intended for food and feed use. Initially, the Secretary of Health evaluated the food safety of biotechnological products, based on this article, for commercialization with purposes of food, feed and processing. Subsequently in 2005, with the entry into force of the Law on Biosafety of Genetically Modified Organisms (LBOGM), the regulation was adapted to give rise to the Authorization, which is the administrative act through which the Secretary of Health, by means of the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), authorizes Genetically Modified Organisms (GMOs), to their commercialization, as well as their use for purposes of public health or bioremediation.
The faculties that correspond to the Secretary of Health are stipulated in Article 16 of the LBOGM and what is related to the Authorizations is described in Articles 91 to 98 of this Law. Those who seek to obtain an Authorization for GMOs merchandising and importation, must present to COFEPRIS, a written request accompanied by the information referred into articles 23 to 32 of the Regulation of the Law on Biosafety of Genetically Modified Organisms.
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
BASF Plant Science Company GmbH |
| Summary of application: |
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| Date of authorization: |
20/09/2012 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
The safety assessment of soybean line CV127 is provided in the supporting document (SD1) and included the following key elements:
a characterisation of the transferred genes, their origin, function and stability in the
soybean genome
the changes at the level of DNA and protein in the whole food
detailed compositional analyses
evaluation of intended and unintended changes
the potential for the newly expressed proteins to be either allergenic or toxic in
humans.
The assessment of soybean line CV127 was restricted to food safety and nutritional issues. Any risks related to the release into the environment of GM plants used in food production, or the safety of animal feed or animals consuming feed derived from GM plants have not been addressed in this assessment.
No potential public health and safety concerns have been identified.
On the basis of the data provided in the present Application, and other available information, food derived from soybean line CV127 is considered to be as safe for human consumption as food derived from conventional soybean cultivars.
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Application A1064 - Food derived from Herbicide-tolerant Soybean Line CV127
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E-mail:
Organization/agency name (Full name): Ministry for Primary Industries
Contact person name: john vandenbeuken
Website:
Physical full address: Pastoral House, 25 The Terrace, Wellington, 6012
Phone number: 0298942581
Fax number:
Country introduction: New Zealand and Australia share a joint food regulation system for the composition of labelling of most foods. Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of the joint food standards in Australia and New Zealand. The main office (approximately 120 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 15 staff) is located in Wellington on the North Island. Useful links
Relevant documents
Stacked events: FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5) Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
BASF Philippines, Inc |
| Summary of application: |
BASF Philippines, Inc. has developed a new genetically modified soybean that is tolerant to the imidazolinone class of herbicides. The imidazolinone herbicides control a wide spectrum of grass and broadleaf weeds and possess high biological efficacy at low application rates. The herbicide tolerant BPS-CV127 soybean (also referred to as CV127) are derived from a single transformation event and was developed to address weed control challenges to soybean growers. Introduction of CV127 soybean varieties will offer soybean growers an additional tool for controlling problem weeds as well as an important option for weed resistance management. The imidazolinone-tolerant soybean exhibits similar herbicide tolerance properties as various imidazolinone-tolerant crops produced. |
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| Date of authorization: |
29/10/2010 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
BASF Philippines, Inc. submitted an application to the Bureau of Plant Industry requesting for biosafety permit under A.O. #8 for soybean which has been genetically modified for weed resistance.
BASF Philippines, Inc. has provided information on the safe history of use of the crop, the source of the donor gene, the molecular characterization of CV127 soybean, the stability of the inserted genetic elements, characterization and expression levels of AHAS proteins produced in the CV127 soybean plant, lack of any allergenicity or toxicity characteristics associated with AHAS protein and CV127 soybean, as well as the nutrient composition of the soybean grain, forage and grain processed fractions, and overall food and feed safety of CV127 soybean plants. Relevant scientific publications were also supplied.
CV127-9 Soybean has been evaluated according to BPI‘s safety assessment by concerned agencies: Bureau of Animal Industry (BAI), Bureau of Agriculture Fisheries and Product Standards (BAFPS) and a Scientific Technical Review Panel (STRP) members. The process involved an intensive analysis of the nature of the genetic modification with a consideration of general safety issues, toxicological, nutritional and environmental issues associated with the modified soybeans.
The petitioner/applicant published the said application in two (2) widely circulated newspapers for public comment/review. BPI received positive comments on the petition supporting the application for direct use as food and feed or for processing of CV127-9 Soybean during the 30-day comment period.
Review of results of evaluation by the BPI Biotech Core Team completed the approval process.
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E-mail:
Organization/agency name (Full name): Bureau of Plant Industry
Contact person name: Geronima P. Eusebio
Website:
Physical full address: San Andres St., Malate, Manila
Phone number: 632 404 0409 loc 203
Fax number:
Country introduction: In 1987, scientists from the University of the Philippines Los Banos (UPLB) and the International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI), and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD), recognizing the potential harm of the introduction of exotic species and genetic engineering, formed a committee and formulated the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. The committee went on to draft a Philippine biosafety policy, which was submitted to the Office of the President. On October 15, 1990, recognizing the potential for modern biotechnology both in improving the lives of the people and in creating hazards if not handled properly, President Corazon C. Aquino issued Executive Order 430 creating the National Committee on Biosafety of the Philippines (NCBP) that will formulate, review and amend national policy on biosafety and formulate guidelines on the conduct of activities on genetic engineering. The NCBP is comprised of representative of the Departments of Agriculture (DA); Environment and Natural Resources (DENR); Health (DOH); and Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science; and 2 respected members of the community. On July 16, 2001, President Gloria Macapagal-Arroyo issued the Policy Statement on Modern Biotechnology, reiterating the government policy on promoting the safe and responsible use of modern biotechnology. On April 3, 2002, Department of Agriculture Administrative Order No. 8, Series of 2002 was issued implementing the guidelines for importation and release into the environment of Plants and Plant Products Derived from the Use of Modern Biotechnology. On March 17, 2006, President Gloria Macapagal-Arroyo issued Executive Order No.514 Establishing the National Biosafety Framework, prescribing guidelines for its implementation, reorganizing the National Committee on Biosafety of the Philippines, and for other purposes. On December 8, 2015, the Philippine Supreme Court declared DA AO8 null and void and any application for contained use, field testing, propagation and commercialization, and importation of GMOs was temporarily enjoined. In response to the nullification of DA AO8, the Technical Working Group composed of representatives from the Departments of Agriculture (DA), Science and Technology (DOST), Environment and Natural Resources (DENR), Health (DOH), and Interior and Local Government (DILG) drafted the Joint Department Circular No. 1, Series of 2016 (JDC No.1, S2016) titled 'Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically-Modified Plant and Plant Products Derived from the Use of Modern Biotechnology'. There were series of meeting and five public consultations conducted before the JDC No.1, S2016 was approved and signed by the Secretaries of the abovementioned agencies on March 7, 2016 and took effect on April 15, 2016. Under this Circular, more government agencies were involved such as the Department of Science and Technology (DOST) to regulate applications for contained use and confined test of regulated articles; Department of Agriculture (DA) to evaluate applications for field trial, commercial propagation and transboundary movement of regulated articles; Department of Environment and Natural Resources (DENR) to evaluate environmental risks and impacts of regulated articles; Department of Health (DOH) to evaluate of environmental health impacts of regulated articles; and Department of the Interior and Local Government (DILG) to supervise public consultation during field trial.
Useful links
Relevant documents
Stacked events: Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.
Plant Products Carrying Stacked Genes Conferred Through (a) Genetic Engineering or b) Conventional Breeding, with Individual Traits That Have No Prior Approval:
A full risk assessnent as to food and feed or processing shall be conducted,consistent with Part V of AO No. 8,"Approval Process For the Importation of Regulated Articles for Direct Use as Food and Feed or For Processing for plant products with multiple traits conferred through:
(a) genetic engineering, or
(b) conventional breeding, where the individual traits have no prior approval from the Bureau of Plant Industry (BPI) for direct use as food and feed or processing.
Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:
For plant products with multiple traits conferred through conventional breeding,with all individual events granted prior approval and included in the Approval Registry, a notlfication shall be submitted by the technology developer to the BPI, which shall conduct an evaluation in accordance with the relevant criteria in Annex I of this Memorandum Circular. The list of data contained in Annex I will not preclude the inclusion of other issues and concerns that will be raised by the BPI and the Scientific and Technical Review Panel (STRP) during the course of the desktop review.
Notificatlon Requirement for Plant Products Carrying Stacked Genes
All technology developers shall submit a notification to the Bureau of Plant Industry of their developed plant products carrying stacked genes and shall be required to comply with the relevant approval process listed above.
The Bureau of Plant Industry shall issue a certiflcate as to the approval of the stacked gene product and shall likewise include the transformation event in the official approval registry of plant products for food and feed or processing. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004
| Name of product applicant: |
BASF Korea |
| Summary of application: |
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| Date of authorization: |
10/04/2013 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
Please see the link below(in Korean). |
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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E-mail:
Organization/agency name (Full name): Ministry of Food and Drug Safety
Contact person name:
Website:
Physical full address: Osong Health Technology Administration Complex, 187, Osongsaengmyeong 2-ro, Osong-eup, Cheongwon-gun, Chungcheonbuk-do, 363-700, Korea
Phone number: 82-43-719-2360
Fax number:
Country introduction:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
BASF Plant Science Company GmbH |
| Summary of application: |
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| Date of authorization: |
20/07/2012 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
Peer review of the data submitted by the applicant and the results of complex
medical and biological studies of transgenic soybean line BPS-CV127-9 tolerant to sulfonylurea herbicide, attest to the absence of any toxic, genotoxic, sensitization, immunomodulating, or allergenic effects of this soybean line. By biochemical composition, transgenic soybean line BPS-CV127-9 was identical to conventional soybean.
GM soybean line BPS-CV127-9 tolerant to sulfonylurea herbicide has been registered for food use, listed in the State Register, and licensed for use in the territory of the Russian Federation, import into the territory of the Russian Federation, and placing
on the market without restrictions.
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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E-mail:
Organization/agency name (Full name): FSBI «Institute of Nutrition» RAMS
Contact person name: Nadezhda Tyshko
Website:
Physical full address: 109240, Russia, Moscow, Ustinsky Proezd, 2/14
Phone number: +7(495)698-53-64
Fax number:
Country introduction: The development of the GMO safety assessment currently used in the Russian Federation started in 1995–1996. The methodological approaches to comprehensive complex medical and biological assessment of GMOs were developed in the Russian Federation with due regard for international and national experience as well as new scientific approaches based on the achievements of contemporary fundamental science: genomic and proteomic analysis, detection of DNA damage or mutagenic activity, identification of products of free-radical modifications of DNA or other sensitive biomarkers. GMO safety assessment is carried out for the state registration. Any novel food derived from plant GMO produced in Russia or imported into Russia for the first time is subject to the state registration . Guidance for safety assessment is specified in MU 2.3.2.2306-07 “Medico-Biological Safety Assessment of Plant Genetically Modified Organisms”. According to the accepted regulations,the human health assessment of a novel GMO to be placed on the domestic market includes the following: ■ Molecular assessment includes analysis of genetic construction, genetic modification method, and the gene expression level. ■ Technological assessment includes determination of organoleptic and functional properties, analysis of technological characteristics of the finished products. ■ Human health safety assessment includes several sections of required assessments: analysis of compositional equivalence and toxicological,genotoxicological, and allergological safety studies. ■ Methods for identification include qualitative and quantitative assay of GMO in food (studies targeted at determination of correspondence of these methods to those used in Russia in order to provide monitoring of use and labeling of GM food). The list and the scope of required studies is determined on the basis of analysis of information of the GMO submitted for registration; however, the above-mentioned studies are required. If significant changes in the GMO’s genome, proteome, or metabolome are shown, additional studies may be required to determine: biological value and absorbency reproductive effect; gonadotoxic, embryotoxic, teratotoxic effect; potential carcinogenic effect; lifetime, etc. Useful links
Relevant documents
Stacked events: Russia follows the national Methodical Guidelines 2.3.2.3388-16 “Medical and biological safety assessment of genetically modified stack events of plant origin ”
Our position regarding GM stacks registration is very close to the EU approach.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Federal Research Centre of nutrition and biotechnology Viktor A. Tutelyan Ustinsky proezd, 2/14 109240 Moscow, RUSSIA E-mail: [email protected] Tel.:+7 495 698-53-60
| Name of product applicant: |
BASF |
| Summary of application: |
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| Date of authorization: |
20/06/2012 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
Biosafety Clearing House (BCH)
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| Summary of the safety assessment (food safety): |
The GM soybean CV127 has been assessed in terms of the Genetically Modified Organisms Act, 1997 by the Advisory Committee, a scientific panel and the Executive Council an intergovernmental decision making body. The assessment considered amongst others the following: The source of the gene, nature of host organism, protein expression, toxicology and allergenicity issues. |
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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E-mail:
Organization/agency name (Full name): Department of Agriculture Forestry and Fisheries
Contact person name: Nompumelelo Mkhonza
Website:
Physical full address: 30 Hamilton street, Harvest House building, Arcadia, Pretoria, 0001
Phone number: +2712 319 6382
Fax number: +2712 319 6298
Country introduction:
Useful links
Relevant documents
Stacked events: South Africa does not have a specific review/authorization mechanism for stacked events. Stacked events just like single events are subjected to a safety assessment as per the GMO Act. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Department of Agriculture,Forestry and Fisheries (DAFF) http://www.daff.gov.za
| Name of product applicant: |
Special case: please show below |
| Summary of application: |
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| Date of authorization: |
02/08/2017 |
| Scope of authorization: |
Feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
After the evaluation of reports released by Scientific Risk Assessment Committee and
Socio- economic Assessment Committee Biosafety Board has approved the use
of genetically modified soybean BPS-CV127-9 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: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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E-mail:
Organization/agency name (Full name): DG of Agricultural Research and Policies (TAGEM)
Contact person name: Ramazan BULBUL
Website:
Physical full address: Universiteler Mah. Dumlupınar Bulvarı, Eskişehir Yolu 10. Km
Çankaya/ANKARA/TURKEY
Phone number: +90 312 307 60 48
Fax number: +90 312 307 61 90
Country introduction: Turkey is party to the Cartagena Protocol on Biosafety (CPB) since Jan 24, 2004. Biosafety applications in Turkey are carried out within the framework of the Biosafety Law (no.5977) which entered into force in 26 September 2010 and its relevant regulations (“The Regulation on Genetically Modified Organisms and Products” and “The Regulation Connected with Working Procedure and Principles of Biosafety Board and Committees”). Biosafety Law and two regulations came into force on 26th September 2010.
Main objectives of the Biosafety Law are;
- to prevent risks that may arise from GMO’s and products which are produced by using of modern biotechnology by taking into account scientific and technological developments;
- to establish and implement biosafety system to ensure protection and sustainability of environment, biological diversity and health of human, animal and plant;
- to inspect, regulate and monitor the activities in the scope of the law.
The Law includes specific points regarding research, development, processing, releasing on the market, monitoring, using, import, export, handling, transportation, packaging, labelling, storage and similar operations in relation to GMO and GMOPs.
Veterinarian medicinal products and medicinal products for human use and also cosmetic products which are permitted or certified by the Ministry of Health are out of this Law’s scope.
According to Biosafety Law following actions connected with GMO and GMOPs are prohibited:
- Releasing GMO and GMOPs on the market without approval of Ministry of Agriculture and Forestry.
- Production of genetically modified plants and animals.
- Using GMO and GMOPs in baby food and baby formulae, follow-on baby food and follow-on formulae, infant and kid’s nutritional supplements
According to the Biosafety Law, which was enacted in 2010, the Biosafety Board, which was established within the scope of the Law, was responsible for evaluating the applications regarding GMO and its products.
However, the duties and powers of the Biosafety Board were assigned to the Ministry of Agriculture and Forestry with the Presidential Circular No. 2018/3 published in the Official Gazette on the date of August 2, 2018.
The task of evaluating the applications related to GMO and its products, performing the secretarial services of the Committees and other duties specified in the Biosafety Law and related regulations has been assigned to General Directorate of Agricultural Research and Policies (TAGEM) under the Ministry of Agriculture and Forestry pursuant to Ministerial Approval dated 05/12/2018.
Ministry of Agriculture and Forestry makes a “Decision” about applications on GMO and products via taking Scientific Committees’ risk assessment and socio-economic assessment into account.
For each application the Ministry of Agriculture and Forestry assigns a new committee and each committee makes different assessment for each application. It is important to note that in Turkey food and feed each have a different assessment application.
Members of scientific committees are selected from the List of Experts.
11 members are selected for each GMO application.
List of Experts has been made up by the evaluation of Ministry of Agriculture and Forestry from the applicants who applied via using the Biosafety Clearing-House Mechanism of Turkey. Applicants were faculty members and experts of Universities and TÜBİTAK (The Scientific and Technological Research Council of Turkey).
To date, 13 types of GM soybean and 23 types of GM maize were approved as feed for import.
Besides, by the use of aspergillus oryzae, developed through modern biotechnological methods, licences for industrial α-amylase, glucoamylase and hemicellulase enzyme production were granted.
Threshold of labeling of GMO products that are approved by Ministry of Agriculture and Forestry is 0.9%.
There are not any applications for using GMO and products as food.
After placing GMO and GMOPs on the market; the Ministry controls and inspects whether or not conditions designated by decision are met.
Activities of analysis are performed in laboratories designated by the Ministry.
In the case of any non-compliance detected with relation to the GMO Legislation (such as a failure to specify the contained GMO on the label, identification of an unapproved gene, etc.) legal action is taken.
Application evaluation process is like below:
- Evaluation of application by Ministry of Agriculture and Forestry 90 days
- Feedback to the applicant 15 days
- Ministry of Agriculture and Forestry’s “Decision” 270 days
(Starts from feedback to the applicant)
Establishing of Scientific Committees
Report preparation of Committees
Report’s public release
Evaluation of public opinions by Committees
Ministry of Agriculture and Forestry’s final decision after taking reports and public opinions into
account
- Publishing the Positive Decision 30 days
- Reclamation period to Negative Decision 60 days
- Evaluation of reclamation by Ministry of Agriculture and Forestry 60 days
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Ministry of Agriculture and Forestry
General Directorate of Agricultural Research and Policies
Focal Point of the FAO GM Foods Platform
Ramazan BULBUL
Email: [email protected]
| Name of product applicant: |
BASF Plant Science |
| Summary of application: |
Soybean
Trait 1 Added Protein: Large catalytic subunit of acetoxhydroxyacid synthase (At-AHAS-L)
Source: Arabidopsis thaliana
Intended Effect: Tolerance to imidazolinone herbicides
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| Date of authorization: |
01/02/2012 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
Please consult the FDA website links below. |
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
FDA's webpage regarding this variety
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E-mail:
Organization/agency name (Full name): Food and Drug Administration
Contact person name: Jason Dietz
Website:
Physical full address: 5100 Paint Branch Parkway, College Park MD 20740
Phone number: 240-402-2282
Fax number:
Country introduction: The United States is currently in the process of populating this database. The Food and Drug Administration regulates food and feed (food for humans and animals) from genetically engineered crops in conjunction with the Environmental Protection Agency (EPA). EPA regulates pesticides, including those that are plant incorporated protectants genetically engineered into food crops, to make sure that pesticide residues are safe for human and animal consumption and do not pose unreasonable risks of harm to human health or the environment. FDA In the Federal Register of May 29, 1992 (57 FR 22984), FDA published its "Statement of Policy: Foods Derived from New Plant Varieties" (the 1992 policy). The 1992 policy clarified the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act with respect to human and animal foods derived from new plant varieties and provided guidance to industry on scientific and regulatory issues related to these foods. The 1992 policy applied to all foods derived from all new plant varieties, including varieties that are developed using genetic engineering (also known as recombinant deoxyribonucleic acid (rDNA) technology). In the 1992 policy, FDA recommended that developers consult with FDA about foods from genetically engineered plants under development and developers have routinely done so. In June 1996, FDA provided additional guidance to industry on procedures for these consultations (the consultation procedures). These procedures describe a process in which a developer who intends to commercialize food from a genetically engineered plant meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the genetically engineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food. FDA evaluates the submission and if FDA has questions about the summary provided, it requests clarification from the developer. At the conclusion of the consultation FDA responds to the developer by letter. The approach to the safety assessment of genetically engineered food recommended by FDA during consultations, including data and information evaluated, is consistent with that described in the Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants. EPA The safe use of pesticidal substances is regulated by EPA. Food from a genetically engineered plant that is the subject of a consultation with FDA may contain an introduced pesticidal substance, also known as a plant-incorporated protectant (PIP), that is subject to food (food for humans and animals) safety and environmental review by EPA. PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. Both the PIP protein and its genetic material are regulated by EPA. When assessing the potential risks of PIPs, EPA requires studies examining numerous factors, such as risks to human health, non-target organisms and the environment, potential for gene flow, and insect resistance management plans, if needed. In regulating PIPs, decisions are based on scientific standards and input from academia, industry, other Federal agencies, and the public. Before the first PIP product was registered in 1995, EPA required that PIP products be thoroughly tested against human safety standards before they were used on human food and livestock feed crops. EPA scientists assessed a wide variety of potential effects associated with the use of PIPs, including toxicity, and allergenicity. These potential effects were evaluated in light of the public's potential exposures to these pesticides, taking into account all potential combined sources of the exposure (food, drinking water, etc.) to determine the likelihood that a person exposed at these levels would be predisposed to a health risk. Based on its reviews of the scientific studies and often peer reviews by the Federal Insecticide, Fungicide and Rodenticide Scientific Advisory Panel, EPA determined that these genetically engineered PIP products, when used in accordance with approved label directions and use restrictions, would not pose unreasonable risk to human health and the environment during their time-limited registration. Useful links
Relevant documents
Stacked events: Stacked events that are each plant incorporated protectants, as defined by the Environmental Protection Agency, must be registered by the Envriornmental Protection Agency before they can be commercialized. Food/feed safety asssessment of single events are generally sufficient to ensure the safety of food/feed from stacked events. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
Basf S.A. |
| Summary of application: |
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| Date of authorization: |
29/10/2014 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
BCH
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| Summary of the safety assessment (food safety): |
Please refer to uploaded document |
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
GNBio
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E-mail:
Organization/agency name (Full name): Ministerio de Ganadería, Agricultura y Pesca
Contact person name: Alejandra Ferenczi
Website:
Physical full address: Constituyente 1476, Piso 2, Of. 212B. Montevideo, Uruguay
Phone number: +598 2 4104155 int 3
Fax number:
Country introduction: The Uruguayan National Biosafety System (SNB for its acronym in Spanish) includes safety assessments of food end feed, environmental risk assessment, risk management, and risk communication. The National Biosafety Cabinet (GNBio) is the competent authority on biosafety of GMOs. Integrated by: The Minister of Agriculture, MGAP (chair); Minister of Health (MSP); Minister of Economy (MEF); Minister of Environment (MVOTMA); Minister of Foreign Affairs (MRREE); and Minister of Industry (MIEM). This Cabinet is the last responsible to make decisions over a submitted request. It has the authority to define policies to be followed with respect to biosafety in all scopes of GMO application. Other committees of experts and scientists give support to decisions of GNBio through risk analysis of biotechnological products. The Risk Management Commission (CGR) is composed by one delegate of each of the ministries represented within GNBio. The CGR advises GNBio on GMO biosecurity issues; elaborates reference terms for risk assessments; manages the risk communication participation process; is responsible for follow-up and monitoring of authorized events. The Risk Assessment in Biosecurity (ERB) is composed of experts proposed by the CGR and designated by GNBio among specialists in the different areas of risk assessment. Is responsible for considering, on a case-by-case basis, the potential risks and benefits of each new biotech product; assure case-by-case risk assessment evaluation based on scientific methods; writes an operational plan (pre-report) of risk assessment according to CGR directives; advises CGR based on the results of the analysis of risk assessment, and provides information during the consultation process. The Institutional Articulation Committee (CAI) is a committee of technical experts from nine different national public and research institutions, which analyzes the risk assessment of new events and prepares a technical report. The technical analysis is coordinated by ERB organized in different ad hoc groups of experts. The Ad hoc experts groups are technical-scientific specialists in different areas of knowledge related to the analysis of GMO events like characterization and molecular identification of events, environmental and food safety aspects. Useful links
Relevant documents
Stacked events: GM vegetables from cross-pollinated species, such as corn, with stacked events are not considered as a new product. In the case of GM vegetables from self-pollinated species, such as soybean, are considered as a new product even if all single events stacked have already been approved. However, there is an abbreviated analysis procedure in cases where single events were already analyzed. Stacked events not yet analyzed must have the individual risk assessment report. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: GNBio office. E-mail: [email protected]; Adress: Constituyente 1476, piso 2, oficina 212B, Montevideo 11200, Uruguay.
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