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OECD Unique Identifier details

MON-ØØ863-5xMON-ØØ6Ø3-6
Commodity: Corn / Maize
Traits: Coleoptera resistance,Glyphosate tolerance,Kanamycin resistance
European Union
Name of product applicant: Monsanto
Summary of application:

The genetically modified maize MON-ØØ863-5xMON-ØØ6Ø3-6, as described in the application, expresses a modified Cry3Bb1 protein which provides protection to certain coleopteran pests and CP4 EPSPS protein which confers tolerance to glyphosate herbicides. A nptII gene, conferring kanamycin and neomycin resistance, was used as a selectable marker.

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Date of authorization: 02/03/2010
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 methods for genetically modified maize MON-ØØ863-5 and MON-ØØ6Ø3-6 maize validated on MON-ØØ863-5xMON-ØØ6Ø3-6. - Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003. Please see the EU relevant 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) 1/3/2020
E-mail:
fredrik.beckvid-tranchell@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 2 296 65 76
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:
Japan
Name of product applicant: Monsanto Japan Ltd.
Summary of application:

Maize tolerant to glyphosate herbicide and resistant to Coleoptera (cry3Bb1, cp4 epsps, Zea mays subsp. mays (L.) Iltis).

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Date of authorization: 30/06/2003
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.): BioTrack Product Database
Summary of the safety assessment (food safety):
Please see the link below (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 Ministry of Health, Labour and Welfare of Japan (in Japanese)
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
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)

Philippines
Name of product applicant: Monsanto Philippines
Summary of application:
Corn event NK 603 (Trade name: Roundup-Ready Corn) and all corn lines/hybrids derived from this Event contain the CP4 EPSPS coding sequence from Agrobacterium sp CP4 strain. The CP4 EPSPS sequence encodes for the production of the naturally-occurring CP4 EPSPS protein that renders the corn NK 603 tolerant to glyphosate, a herbicide known to be environmentally-compatible.

Corn Event MON 863 (Trade name: Yieldgard Corn Rootworm) and all corn lines/hybrids derived from this event contain the cry3Bb1 coding sequence from Bacillus thuringiensis sp kumamotoensis strain. The cry3Bb1 gene was modified to produce a protein with enhanced insecticidal activity against the coleopteran pest, CRW, and was codon optimized for expression in monocotyledonous
plants.

A commercial inbred line with the inserted genes of MON 863 is developed by the conventional backcrossing of MON 863 and a non transgenic elite inbred line. The resulting commercial inbred line with the inserted genes of MON 863 is then crossed with another inbred line, which contains the inserted genes of Corn NK 603. The resulting seeds are stacked traits F1 hybrid variety.
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Date of authorization: 08/01/2010
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.):
Summary of the safety assessment (food safety):
Monsanto Philippines, Inc. has filed an application with attached technical dossiers to the Bureau of Plant Industry (BPI) for a biosafety notifications for direct use as food, feed and for processing under Department of Agriculture (DA) Administrative Order (AO) No. 8 Part 5 for Combined trait product corn: Nk603 x MON863 which has been genetically modified for herbicide tolerance and insect resistance. A safety assessment of combined trait product corn: Nk603 x MON863 was conducted as per AO 8 Series of 2002. 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.

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

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 applicant is not product developers for our country.


 


Turkish Poultry Meat Producers and Breeders Association

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Date of authorization: 05/11/2015
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 Biosafety Board has approved the use of genetically modified maize MON863xNK603 and products thereof for animal feed.
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
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

 

 

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