Food safety and quality
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OECD Unique Identifier details

DAS-Ø6275-8
Commodity: Corn / Maize
Traits: Glufosinate tolerance,Lepidoptera resistance
Canada
Name of product applicant: Dow AgroSciences Canada Inc.
Summary of application:
Dow AgroSciences has developed corn (Zea mays) lines based upon transformation event TC6275. Corn plants containing this vector stacked trait event express two novel proteins: phosphinothricin acetyl-transferase (PAT) which confers tolerance to glufosinate herbicides, and the Cry1F protein which exhibits insecticidal activity against certain Lepidopteran pests such as the European Corn Borer (Ostrinia nublialis).

Health Canada has previously indicated no objection to the sale of the insect resistant, glufosinate tolerant corn event 1507 expressing the Cry1F and PAT proteins for human food applications. The Cry1F protein from event 1507 is identical to that expressed in TC6275. The PAT protein from event 1507 is a variant sharing 85% amino acid sequence identity with that expressed in TC6275. Health Canada has also previously indicated no objection to the sale of the single trait glufosinate tolerant corn event DLL25 for human food applications. The PAT protein from event DLL25 is identical to that expressed in TC6275.

The safety assessment performed by Food Directorate evaluators was conducted according to Health Canada's Guidelines for the Safety Assessment of Novel Foods. The assessment considered: how corn event TC6275 was developed; how the composition and nutritional quality of corn grain derived from plants containing this event compare to non-modified corn; and what the potential is for food products derived from plants containing this event to be toxic or cause allergic reactions.

The Food Directorate has a legislated responsibility for pre-market assessment of novel foods and novel food ingredients as detailed in Division 28 of Part B of the Food and Drug Regulations (Novel Foods). Foods derived from corn lines containing event TC6275 are considered novel foods under the following part of the definition of novel foods: "c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that

i) the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism".


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Date of authorization: 28/06/2006
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.): BioTrack Product Database
Summary of the safety assessment (food safety):
Please see decision document weblinks
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Novel Foods Decision
Novel Feeds Decision
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Neil.Strand@hc-sc.gc.ca
Organization/agency name (Full name):
Health Canada
Contact person name:
Neil Strand
Website:
Physical full address:
251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number:
613-946-1317
Fax number:
Country introduction:

Federal responsibility for the regulations dealing with foods sold in Canada, including novel foods, is shared by Health Canada and the Canadian Food Inspection Agency (CFIA). Health Canada is responsible for establishing standards and policies governing the safety and nutritional quality of foods and developing labelling policies related to health and nutrition. The CFIA develops standards related to the packaging, labelling and advertising of foods, and handles all inspection and enforcement duties. The CFIA also has responsibility for the regulation of seeds, veterinary biologics, fertilizers and livestock feeds. More specifically, CFIA is responsible for the regulations and guidelines dealing with cultivating plants with novel traits and dealing with livestock feeds and for conducting the respective safety assessments, whereas Health Canada is responsible for the regulations and guidelines pertaining to novel foods and for conducting safety assessments of novel foods.

The mechanism by which Health Canada controls the sale of novel foods in Canada is the mandatory pre-market notification requirement as set out in Division 28 of Part B of the Food and Drug Regulations.

Manufacturers or importers are required under these regulations to submit information to Health Canada regarding the product in question so that a determination can be made with respect to the product's safety prior to sale. The safety criteria for the assessment of novel foods outlined in the current guidance document (i.e. Canadian Guidelines for the Safety Assessment of Novel Foods) were derived from internationally established scientific principles and guidelines developed through the work of the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organisation (FAO), World Health Organisation (WHO) and the Codex Alimentarius Commission. These guidelines provide for both the rigour and the flexibility required to determine the need for notification and to conduct the safety assessment of the broad range of food products being developed. This flexibility is needed to allow novel foods and food products to be assessed on a case-by-case basis and to take into consideration future scientific advances.

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Relevant documents
Stacked events:

Food: Consistent with the definition of "novel food" in Division 28 of the Food and Drug Regulations, the progeny derived from the conventional breeding of approved genetically modified plants (one or both parents are genetically modified) would not be classified as a novel food unless some form of novelty was introduced into such progeny as a result of the cross, hence triggering the requirement for pre-market notification under Division 28. For example, notification may be required for modifications observed in the progeny that result in a change of existing characteristics of the plant that places those characteristics outside of the accepted range, or, that introduce new characteristics not previously observed in that plant (e.g. a major change has occurred in the expression levels of traits when stacked). In addition, the use of a wild species (interspecific cross) not having a history of safe use in the food supply in the development of a new plant line may also require notification to Health Canada. However, molecular stacks are considered new events and are considered to be notifiable as per Division 28.

Feed:

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

Neil Strand, Section Head of Novel Foods

Japan
Name of product applicant: Dow Chemical JapanLtd.
Summary of application:

Maize resistant to Lepidoptera and tolerant to glufosinate herbicide.


(Modified cry1F, modified bar, Zea mays subsp. mays (L.) Iltis)

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Date of authorization: 17/08/2007
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): OECD BioTrack Product Database
Summary of the safety assessment (food safety):
Please see the links below.
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Food safety assessment performed by Food Safety Commission of Japan (Food)
Food safety assessment performed by Food Safety Commission of Japan (Feed)
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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)

United States of America
Name of product applicant: Dow AgroSciences
Summary of application:

Maize Optimized Cry1F Maize

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Date of authorization: 27/05/2005
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.): EPA BRAD
FDA Consultation
Summary of the safety assessment (food safety):
Please see EPA BRAD and FDA consultation.
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:
cristina.soerensen@mag.gov.py
Organization/agency name (Full name):
Ministerio de Agricultura y Ganadería
Contact person name:
María Cristina Soerensen Gonzalez
Website:
Physical full address:
Yegros 437 entre 25 de mayo y Cerro Cora
Phone number:
+595 21 492948
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: