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OECD Unique Identifier details

DAS-Ø15Ø7-1xDAS-59122-7
Commodity: Corn / Maize
Traits: Coleoptera resistance,Glufosinate tolerance,Lepidoptera resistance
European Union
Name of product applicant: Pioneer
Summary of application:

The genetically modified maize DAS-59122-7xDAS-Ø15Ø7xMON-ØØ6Ø3-6, as described in the application, expresses the Cry1F protein which confers protection against certain lepidopteran pests, Cry34Ab1 and Cry35Ab1 proteins which confer protection against certain coleopteran pests and the PAT protein which confers tolerance to the glufosinate-ammonium herbicides.


 

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Date of authorization: 28/07/2010
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.): Biosafety Clearing House (BCH)
OECD BioTrack Product Database
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:
Event specific real-time quantitative PCR based method for genetically modified maize DAS-Ø15Ø7xDAS-59122-7. - Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003. Please see the relevant EU links 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) 27/7/2020
E-mail:
pablo.pindado-carrion@ec.europa.eu
Organization/agency name (Full name):
European Union
Contact person name:
Pablo PINDADO
Website:
Physical full address:
European Commission B232 04/106 1047 Brussels
Phone number:
00 32 2 298 67 06
Fax number:
Country introduction:

The process for authorising a new GMO is based on the EU regulation on GM food and feed (1829/2003). An application for authorising food or feed consisting of or made from a GMO must be submitted to the national authorities. The national authority then sends the application to the European Food Safety Agency (EFSA) for a risk assessment. EFSA then makes the application summary available to the public. No matter where in the EU the company applies, EFSA assesses the risks the GMO presents for the environment, human health and animal safety. If the application covers cultivation, EFSA delegates the environmental risk assessment to an EU country which sends EFSA its risk assessment report. After performing the risk assessment, EFSA submits its scientific opinion to the European Commission and to EU countries. The opinion is made available to the public, except for certain confidential aspects. Once EFSA publishes its risk assessment, the public has 30 days to comment on the Commission website for applications under Reg. 1829/2003, and on the Joint Research Centre website on the assessment report of the "lead" EU country for applications under Directive 2001/18. Within 3 months of receiving EFSA's opinion, the Commission grants or refuses the authorisation in a proposal. If it differs from EFSA’s opinion, it must explain why. National representatives approve the Commission’s proposal by qualified majority in: (1) The Standing Committee on the Food Chain and Animal Health if the application was submitted under Reg. 1829/2003; (2) The Regulatory Committee under Directive 2001/18/EC if the application was submitted under Dir. 2001/18. The proposal is adopted if the Committee agrees with it. If there is no opinion, the Commission may summon an Appeal Committee where EU countries can adopt or reject the proposal. If the Appeal Committee makes no decision, the Commission may adopt its proposal. Authorisations are valid for 10 years (renewable).

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Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Brazil
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
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:
gutemberg.sousa@mcti.gov.br
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Edivaldo Domingues Velini
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556134115516
Fax number:
556133177475
Country introduction:
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. Edivaldo Domingues Velini (President of national Biosafety Commission)

Japan
Name of product applicant: DuPont K.K.
Summary of application:

1507×B.t. Cry34/35Ab 1 Event DAS-59122-7 (DAS-01507-1×DAS-59122-7) has been genetically modified for herbicide tolerance and insect resistance.

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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
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:
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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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
fscj-secretariat@cao.go.jp
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,GOJ
Contact person name:
Emi Takagi
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:
Useful links
Relevant documents
Stacked events:

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

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

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

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

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

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

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

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

Mexico
Name of product applicant: Híbridos Pioneer de México, S.A. de C.V. - Dow AgroSciences, S.A. de C.V.
Summary of application:

Authorization by COFEPRIS: 38


The genetically modified maize DAS-59122-7xDAS-Ø15Ø7xMON-ØØ6Ø3-6, as described in the application, expresses the Cry1F protein which confers protection against certain lepidopteran pests, Cry34Ab1 and Cry35Ab1 proteins which confer protection against certain coleopteran pests and the PAT protein which confers tolerance to the glufosinate-ammonium herbicides.

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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.):
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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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
sortiz@conacyt.mx
Organization/agency name (Full name):
CIBIOGEM
Contact person name:
Dra. Sol Ortiz García
Website:
Physical full address:
San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number:
+52 (55) 5575-6878
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:

Secretaría de Salud / Phone: +52 55 5080 5200 /Email: ralatorre@cofepris.gob.mx%20

Philippines
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.):
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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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
bpibiotechsecretariat@yahoo.com
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Merle B. Palacpac
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 521 1080
Fax number:
632 521 1080
Country introduction:

The Philippines is the first ASEAN country to establish a modern regulatory system for modern biotechnology. The country's biosafety regulatory system follows strict scientific standards and has become a model for member-countries of the ASEAN seeking to become producers of agricultural biotechnology crops. Concerns on biosafety in the Philippines started as early as 1987 when scientists from the University of the Philippines Los Banos (UPLB) and 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) recognized the potential for harm of the introduction of exotic species and genetic engineering.

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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

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

Application for direct use as feed


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


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

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Date of authorization: 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.):
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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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
iozkan@tagem.gov.tr
Organization/agency name (Full name):
General Directorate of Agricultural Research and Policy
Contact person name:
İsa Özkan
Website:
Physical full address:
İstanbul Yolu üzeri, Tarım Kampüsü No:38 06171 Yenimahalle/Ankara/Turkey
Phone number:
+90 312 315 52 86
Fax number:
+90 312 315 26 98
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. According to Biosafety Law it is forbidden to cultivate GM crops and animals, in Turkey. Biosafety Board founded in 22nd September 2010 to evaluate applications about GMO and products and perform tasks that are written in Biosafety Law and related regulations. Biosafety Board makes a “Decision” about applications on GMO and products via taking Scientific Committees’ risk assessment and socio-economic assessment into account. To date, 7 types of GM soybean and 25 types of GM maize were approved as feed for import.

 

For food, 29 different varieties (3 soybean, 21 maize, 3 oilseed rape, 1 sugar beet, 1 potato) has been applied and risk assessment for soybean and maize has been opened to public opinion. However, applicants withdrew due to the public pressure so Biosafety Board has not made any decision.

 

Biosafety Board makes a “Decision” about applications on GMO and products via taking Scientific Committees’ risk assessment and socio-economic assessment into account. Application evaluation process is like below:

  • Evaluation of application by Biosafety Board                              90 days
  • Feedback to the applicant                                                         15 days
  • Biosafety Board’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
  • Board’s final decision after taking reports and public opinions into account
  • Report’s presentation to Ministry by Board
  • Publishing the Positive Decision                                                30 days
  • Reclamation period to Negative Decision                                   60 days
  • Evaluation of reclamation by Board                                          60 days

 

Table 1: Decisions for GMO’s Depending on Usage

 

Usage

Positive

Negative

Date of desicion

Feed

3 GM soybean

-

Official   Gazette  no 27827 in  26 January    2011

Feed

16 GM maize

-

Official Gazette    no 28152 in  24 December 2011   (13 GM maize)

Official Gazette    no 28271 in  21 April 2012 (3 GM   maize)

Feed

-

6 GM  maize

13. Biosafety   Board Meeting decision

(26 March 2012)

Feed

-

3 GM oilseed rape

16. Biosafety   Board Meeting decision

(19 November 2012)

Feed

-

1 GM sugar beet

16. Biosafety   Board Meeting decision

(19 November 2012)

Bioetanol

-

22 GM maize

16. Biosafety   Board Meeting decision

(19 November 2012)

Feed

3 GM maize

-

Official   Gazette  no 29418 in  16 July 2015

Feed

2 GM soybean

-

Official   Gazette  no 29418 in  16 July 2015

Feed

2 GM soybean

-

Official   Gazette  no 29523 in  5 November 2015

Feed

6 GM maize

-

Official Gazette    no 29523 in  5 November 2015

 

 

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