| Commodity: |
Corn / Maize |
| Traits: |
Coleoptera resistance,Glufosinate tolerance,Lepidoptera resistance |
| Name of product applicant: |
Pioneer |
| Summary of application: |
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| Date of authorization: |
03/08/2018 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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: the quantitative event-specific PCR detection methods for maize 1507 × 59122 × MON 810 × NK603 are those validated for genetically modified maize events DAS-Ø15Ø7-1, DAS-59122-7, MON-ØØ81Ø-6 and MON-ØØ6Ø3-6. Reference material: ERM®-BF418 (for DAS-Ø15Ø7-1), ERM®-BF424 (for DAS-59122-7), ERM®-BF413 (for MON-ØØ81Ø-6) and ERM®-BF415 (for MON-ØØ6Ø3-6) are accessible via the Joint Research Centre (JRC) of the European Commission. The relevant links are provided below. |
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Method for detection
Reference Material
Opinion of the European Food Safety Authority
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| Authorization expiration date (a blank field means there is no expiration date) |
05/08/2028 |
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: |
Du Pont do Brasil & Dow AgroSicence |
| Summary of application: |
Commercial release of genetically modified maize insect resistant and tolerant to glufosinate ammonium, event TC1507 x DAS-59122-7 |
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| Date of authorization: |
20/06/2013 |
| 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.): |
Center for Environmental Risk Assessment
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| Summary of the safety assessment (food safety): |
The event TC1507 x DAS-59122-7 was generated by crossing the maize TC1507 and DAS-59122-7, for classical genetic crosses, being possessed of genes and Cry1F/pat Cry34Ab1/Cry35Ab1/pat, and are responsible for the production of proteins Cry1F / phosphinothricin acetyltransferase (PAT) and Cry34Ab1/Cry35Ab1/PAT. Proteins Cry34Ab1 and Cry35Ab1 are directed to the protection of plants against insect pests of the order Coleoptera root while. Cry1F have specific action against insect pests of the order Lepidoptera. Additionally, maize TC1507 × DAS-59122-7 PAT protein expressed in both events parenting, responsible for tolerance to the herbicide glufosinate ammonium. The PAT protein is an enzyme that acts on glufosinate ammonium, being able to modify it, rendering it inactive, phosphinothricin by acetylation of the free amine in its grouping. Protein expression studies were carried out in Brazil with events TC1507, DAS-59122-7 and the combined event TC1507 x DAS-59122-7. For analysis of protein expression corn TC1507 x DAS-59122-7 protein Cry1F, PAT and Cry34Ab1 Cry35Ab1 were measured using the quantitative method of Enzyme Linked Immunosorbent Assay (ELISA) in tissues of leaf, pollen, root, whole plant, forage and grains, resulting in the combined event, compared with simple events, similarity of values, corroborating the results obtained for phenotypic, agronomic, compositional and reproductive, indicating absence of gene interaction arising from sexual reproduction.
Corn TC1507 × DAS-59122-7 shows Mendelian inheritance expected for independent loci. The phenotypic stability of the event TC1507 x DAS-59122-7 was observed for more than 10 generations during the conversion of production lines and hybrids. In every generation there is the characteristic of tolerance to the herbicide glufosinate ammonium, which is inherited stably. Likewise, the characteristic of resistance to coleopteran and lepidopteran insects pests also remained stable and was transferred as expected for all successive generations of progeny during the conversion process. The expression results also confirm these observations, showing stability of expression levels of proteins Cry1F, Cry34Ab1, Cry35Ab1 and PAT maize TC1507 x DAS-59122-7. Substantial equivalence combined corn compared to conventional corn, and rapid denaturation and degradation of proteins Cry1F Cry34Ab1, Cry35Ab1 and PAT during processing, attest to the safety of the consumption of genetically modified maize and products derived from it. Analysis of the nutritional composition of maize TC1507 x DAS-59122-7 opposite to conventional corn show similarity between the two products with respect to the content of protein, fiber, carbohydrates, oils, ash, minerals, fatty acids, amino acids, vitamins, metabolites and anti-nutrients . This similarity confirms data published in scientific-technical literature on maize TC1507 x DAS-59122-7 that the presence of cry genes that confer control of insect pests and the pat gene which determines tolerance to the herbicide glufosinate ammonium does not cause changes the nutritional composition of the GMO, as well as those that may be caused by biotic to abiotic.
Proteins Cry1F, Cry34Ab1, Cry35Ab1 and PAT no have homology with allergenic proteins considered, either with known toxins. These proteins were tested for acute oral toxicity study in mice to evaluate the potential toxicity to humans and animals. No acute effect, chronic or subchronic was detected due to the consumption of these proteins. Research conducted in Brazil showed that maize TC1507 x DAS-59122-7 did not differ from conventional maize on agronomic, morphological, reproductive, as well as the chemical and nutritional composition, with the exception only of the characteristics of tolerance to the herbicide glufosinate-based ammonium and the characteristics of insect resistance. The agronomic traits for the comparative study of the effect of the event TC1507 x DAS-59122-7 used as a reference control corn with the same genetic background combined event. The comparative analysis of treatments indicated that no statistically significant difference was observed between transgenic maize TC1507 x DAS-59122-7 with respect to conventional corn. The agronomic data, botanic and reproductive behaviors of combined event TC1507 x DAS-59122-7 and its simple events (TC1507 and DAS-59122-7), compared to their conventional hybrids in different germplasm, demonstrated the similarity of the TC1507 × maize DAS-59122-7 and its components with conventional maize. Data from studies of the environmental assessment shows that the introduction of simple event TC1507 and DAS-59122-7 in combined event TC1507 x DAS-59122-7 in maize adapted to the abiotic and biotic Brazilian caused no adverse effect on the morphology, physiology, reproductive characteristics, type of dissemination of plant response to major pathogens, survival characteristics, except for changing the response of plants to control insect pests of shoots and roots of maize. Given the above CTNBio concludes that the cultivation and consumption of maize TC1507 x DAS-59122-7 is not potentially cause significant degradation of the environment, or risks to human and animal health. For this reason, there are no restrictions on the use of this corn and its derivatives. The monitoring shall be submitted by the company in accordance with the standards contained in the Normative Resolution No. 9 of December 2, 2011 CTNBio
CTNBio examined the reports submitted by the applicants and independent scientific literature.
Under the powers conferred by Art. 14 of the Low 11. 105/05, CTNBio considered that the application meets the standards and legislation to ensure the biosafety of the environment, agriculture, human and animal health and concluded that maize TC1507 x DAS-59122-7
is substantially equivalent to conventional maize consumption being safe for human and animal health. Regarding the environment, CTNBio concluded that cultivation of maize TC1507 x DAS-59122-7 is not potentially cause significant degradation of the environment, biota keeping with the identical relation to conventional corn.
CTNBio clarifies that this statement does not exempt the applicant from complying with other existing laws in the country, applicable to the subject of the application. |
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
molecular traditional methods |
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
National Biosafety Commission
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| Authorization expiration date (a blank field means there is no expiration date) |
Not Applicable |
E-mail:
Organization/agency name (Full name): National Biosafety Technical Commission
Contact person name: Paulo Augusto Viana Barroso
Website:
Physical full address: SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number: 556120335087
Fax number:
Country introduction: Brazil had the first biosafety law approved in 1995. After the identification of the need to improve the biosafety system of Brazilian genetically modified organisms, a new law was published. The Law 11.105 / 05 establishes a technical committee dedicated to the analysis of the safety aspects of genetically modified organisms and a council of ministers that is dedicated to the analysis of the socioeconomic aspects of the commercial release of genetically modified organisms. In this context, Brazil already has several commercial products that involve genetically modified organisms (plants, human and veterinary vaccines, microorganisms for fuel production) and products derived from new genetic modification techniques. Useful links
Relevant documents
Stacked events: At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Dr. Paulo Augusto Viana Barroso (President of national Biosafety Commission)
| Name of product applicant: |
Dupont Colombia S.A |
| Summary of application: |
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| Date of authorization: |
04/07/2018 |
| 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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| 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): 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: |
Dow AgroSciences & Pioneer Hi-Bred International Inc. |
| Summary of application: |
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| Date of authorization: |
29/10/2016 |
| Scope of authorization: |
Feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
Competent National Authority: Ministry of Agriculture-Jehad, Agricultural Research, Education and Extension Organization (AREEO). Risk Assessment file is uploaded.
https://bch.cbd.int/en/database/RA/BCH-RA-IR-114174/2 |
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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): ABRII
Contact person name: Gholamreza Salehi Jouzani
Website:
Physical full address: Agricultural Biotechnology Research Institute of Iran (ABRII), Mahdasht Road, 31535-1897, Karaj, Iran
Phone number: 0098(26)32701132
Fax number: 0098(26)32701132
Country introduction: Iran has ratified Cartagena Protocol on Biosafety in 2003. The National Biosafety Law has also been ratified in 2009. The regulations for the National Biosafety Law have been prepared and approved during last ten years. All these laws and regulations deal with Living GMOs (LMOs) and there is no Law for the regulation of the non-living GMOs. All these laws and regulations are accessible at: http://bch.cbd.int/database/results?searchid=622770. Codex principles for the risk analysis of foods derived from modern biotechnology and other guidelines such as the Codex guidelines for the conduct of food safety assessment of foods produced using recombinant-DNA plants and microorganisms are widely accepted and used.
The process for authorization of new LMO release includes comprehensive risk assessment and management analysis. Ministry of Agriculture (Jihade Keshavarzi) is responsible for approval of the release, import, export, transit and use of Agricultural Related LMOs. The requests should be forwarded to: a[email protected]; with a CC to National Focal Point: [email protected]. Cartagena Protocol on Biosafety National Focal Point is in charge of all liaison affairs related to the Cartagena Protocol on Biosafety and acts as the contact point for the communications received. The Ministry of Health and Medical Education is in charge with the approval of all LMOs related to food and medicine. Environmental Protection Organization is in charge with the environmental release of LMOs in the wild nature and/or related to the wild organisms. Detailed procedure for authorization of GM food and feed is under preparation. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
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Agricultural Jihad Ministry
Tehran, Tehran
Iran (Islamic Republic of)
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Ministry of Health and Medical Education- Food & Drug Administration
Food and Drug Administration, Fakhrerazi St., Enghelab Ave.
Tehran
Iran (Islamic Republic of), 1314715311
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| Name of product applicant: |
DuPont K.K. |
| Summary of application: |
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| Date of authorization: |
15/12/2005 |
| 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): |
Please refer to the link below of safety assessment performed by Food Safety Commission of Japan (in Japanese). |
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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: |
Food safety assessment performed by Food Safety Commission of Japan (in Japanese)
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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: |
Híbridos Pioneer de México, S.A. de C.V. - Dow AgroSciences, S.A. de C.V. |
| Summary of application: |
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| Date of authorization: |
26/05/2006 |
| 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: DAS-Ø15Ø7-1xDAS-59122-7
During the risk assessment of this GMO based on existing knowledge to date, no toxic or allergic effects neither substantial nutritional changes are observed. The event is as safe as its conventional counterpart.
For more detail please find attached the risk assessment summary in this page.
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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E-mail:
Organization/agency name (Full name): CIBIOGEM
Contact person name: Dra. Consuelo López López
Website:
Physical full address: San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number: +52 (55) 53227700
Fax number:
Country introduction: México ha buscado garantizar la inocuidad de los productos biotecnológicos para el uso y consumo de su población.
Desde 1984 el artículo 282 bis 1 de la Ley General de Salud, contempló que la Secretaría de Salud debería regular aquellos productos biotecnológicos, o sus derivados, destinados al uso o consumo humano.
En un inicio, con fundamento en este artículo, la Secretaria de Salud evaluó la inocuidad alimentaria de productos biotecnológicos, para su comercialización con fines de uso o consumo humano. A partir de 2005, con la entrada en vigor de la Ley de Bioseguridad de Organismos Genéticamente Modificados (LBOGM), se realizó la adecuación de la regulación para dar lugar a la Autorización que es el acto administrativo mediante el cual la Secretaría de Salud, a través de la Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), autoriza Organismos Genéticamente Modificados (OGMs), a efecto de que se pueda realizar su comercialización, así como su utilización con finalidades de Salud Pública o de Biorremediación.
Las facultades que corresponden a la Secretaría de Salud se estipulan en el artículo 16 de la LBOGM y lo relativo a la Autorizaciones se describe en los artículos 91 al 98 de dicha Ley.
Quienes pretendan obtener una Autorización para Comercialización e Importación de OGMs deben presentar ante COFEPRIS, una solicitud por escrito acompañada de la información a que se refiere los artículos 23 al 32 del Reglamento de la Ley de Bioseguridad de OGMs.
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf
Courtesy translation
Mexico has sought to guarantee the safety of biotechnological products the use and consumption of its population. Since 1984, article 282 bis 1 from the General Law of Health, considered that the Secretary of Health should regulate those biotechnological products, or their derivatives, intended for food and feed use. Initially, the Secretary of Health evaluated the food safety of biotechnological products, based on this article, for commercialization with purposes of food, feed and processing. Subsequently in 2005, with the entry into force of the Law on Biosafety of Genetically Modified Organisms (LBOGM), the regulation was adapted to give rise to the Authorization, which is the administrative act through which the Secretary of Health, by means of the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), authorizes Genetically Modified Organisms (GMOs), to their commercialization, as well as their use for purposes of public health or bioremediation.
The faculties that correspond to the Secretary of Health are stipulated in Article 16 of the LBOGM and what is related to the Authorizations is described in Articles 91 to 98 of this Law. Those who seek to obtain an Authorization for GMOs merchandising and importation, must present to COFEPRIS, a written request accompanied by the information referred into articles 23 to 32 of the Regulation of the Law on Biosafety of Genetically Modified Organisms.
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
Pioneer Hi-Bred Phillipines and Dow AgroSciences |
| Summary of application: |
The 1507 x 59122 maize has been obtained from traditional breeding methods between progeny of two genetically modified maize. The two GM maize events are DAS-59122-7 referred to as 59122 maize and DAS-Ø15Ø 7-1, referred to as 1507 maize. No new genetic modification has been introduced in 1507 x 59122 maize.
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| Date of authorization: |
07/02/2012 |
| 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): |
Pioneer Hi Bred Philippines and Dow Agro Sciences of the Philippines have filed an application with attached technical dossiers to the Bureau of Plant Industry (BPI) for a biosafety notification for direct use as food, feed and for processing under Department of Agriculture (DA)- Administrative Order (AO) No. 8 Part 5 for combined trait corn: 1507 x 59122 which has been genetically modified for insect protection and herbicide tolerance.
A safety assessment of combined trait product corn: 1507 x 59122 was conducted as per Administrative Order No. 8 Series of 2002 and Memorandum Circulars Nos. 6 and 8, Series of 2004. The focus of risk assessment is the gene interactions between the two transgenes.
Review of results of evaluation by the BPI Biotech Core Team in consultation with DA-Biotechnology Advisory Team (DA-BAT) completed the approval process.
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| 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): 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: |
DuPont (Korea) Inc. |
| Summary of application: |
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| Date of authorization: |
02/02/2006 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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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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| Authorization expiration date (a blank field means there is no expiration date) |
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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: |
Special case: please show below |
| Summary of application: |
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| Date of authorization: |
21/04/2012 |
| Scope of authorization: |
Feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
After the evaluation of reports released by Scientific Risk Assessment Committee and
Socio- economic Assessment Committee and also by considering public opinion,
Biosafety Board has approved the use of genetically modified maize 1507x59122 and products thereof for animal feed. |
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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]
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