| Commodity: |
Canola / Oilseed rape / Rape Seed |
| Traits: |
Glufosinate tolerance,Kanamycin resistance |
| Name of product applicant: |
Bayer CropScience Canada |
| Summary of application: |
The MS1 and RF2 lines of canola (Brassica napus) were developed through a specific genetic modification of cultivar Drakkar to display the traits of nuclear male sterility and fertility restoration, respectively, and to be tolerant to glufosinate ammonium herbicide. The induction of male sterility (MS) was accomplished by insertion of the gene encoding barnase ribonuclease (RNase), and enzyme that disrupts RNA production and thus normal cell functioning resulting in arrested anther development. The trait of restored fertility (RF) was due to the introduction of the gene encoding a specific inhibitor of the barnase RNase. Only hybrids derived from the crossing of MS1 and RF2 are fertile. Both of the novel varieties, MS1 and RF2, contain a gene encoding the enzyme, phosphinothricin N-acetyl transferase (PAT), from Streptomyces hygroscopicus. Phosphinothricin containing herbicides, such as glufosinate ammonium, act by inhibiting glutamine synthetase resulting in the accumulation of toxic levels of ammonia. The PAT enzyme detoxifies phosphinothricin by acetylation into an inactive compound. Hybrids derived from MS1 and RF2 crosses permit farmers to use phosphinothricin containing herbicides for weed control in the cultivation of canola.
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| Date of authorization: |
17/08/1995 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
BioTrack Product Database
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| Summary of the safety assessment (food safety): |
Please see decision document weblinks |
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| 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: |
Novel Foods Decision
Novel Feeds Decision
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E-mail:
Organization/agency name (Full name): Health Canada
Contact person name: Neil Strand
Website:
Physical full address: 251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number: 613-946-1317
Fax number:
Country introduction: Federal responsibility for the regulations dealing with foods sold in Canada, including novel foods, is shared by Health Canada and the Canadian Food Inspection Agency (CFIA). Health Canada is responsible for establishing standards and policies governing the safety and nutritional quality of foods and developing labelling policies related to health and nutrition. The CFIA develops standards related to the packaging, labelling and advertising of foods, and handles all inspection and enforcement duties. The CFIA also has responsibility for the regulation of seeds, veterinary biologics, fertilizers and livestock feeds. More specifically, CFIA is responsible for the regulations and guidelines dealing with cultivating plants with novel traits and dealing with livestock feeds and for conducting the respective safety assessments, whereas Health Canada is responsible for the regulations and guidelines pertaining to novel foods and for conducting safety assessments of novel foods.
The mechanism by which Health Canada controls the sale of novel foods in Canada is the mandatory pre-market notification requirement as set out in Division 28 of Part B of the Food and Drug Regulations.
Manufacturers or importers are required under these regulations to submit information to Health Canada regarding the product in question so that a determination can be made with respect to the product's safety prior to sale. The safety criteria for the assessment of novel foods outlined in the current guidance document (i.e. Canadian Guidelines for the Safety Assessment of Novel Foods) were derived from internationally established scientific principles and guidelines developed through the work of the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organisation (FAO), World Health Organisation (WHO) and the Codex Alimentarius Commission. These guidelines provide for both the rigour and the flexibility required to determine the need for notification and to conduct the safety assessment of the broad range of food products being developed. This flexibility is needed to allow novel foods and food products to be assessed on a case-by-case basis and to take into consideration future scientific advances. Useful links
Relevant documents
Stacked events: Food: Consistent with the definition of "novel food" in Division 28 of the Food and Drug Regulations, the progeny derived from the conventional breeding of approved genetically modified plants (one or both parents are genetically modified) would not be classified as a novel food unless some form of novelty was introduced into such progeny as a result of the cross, hence triggering the requirement for pre-market notification under Division 28. For example, notification may be required for modifications observed in the progeny that result in a change of existing characteristics of the plant that places those characteristics outside of the accepted range, or, that introduce new characteristics not previously observed in that plant (e.g. a major change has occurred in the expression levels of traits when stacked). In addition, the use of a wild species (interspecific cross) not having a history of safe use in the food supply in the development of a new plant line may also require notification to Health Canada. However, molecular stacks are considered new events and are considered to be notifiable as per Division 28.
Feed: Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Neil Strand, Section Head of Novel Foods
| Name of product applicant: |
Bayer Cropscience |
| Summary of application: |
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| Date of authorization: |
06/04/2004 |
| 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): |
Please see decision document uploaded |
| Upload: |
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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: |
Chinese Agriculture Department Announcement No. 869-6-2007: Detection of Genetically Modified Plants and Derived Products Qualitative PCR Method for Herbicide-Tolerant Rapeseed MS1,RF2 and Their Derivates |
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Authority concern of GMO
Ministry of Agriculture of China
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| Authorization expiration date (a blank field means there is no expiration date) |
6/4/2007 |
E-mail:
Organization/agency name (Full name): Development Center for Science and Technology, Min
Contact person name: Fu Zhongwen
Website:
Physical full address: Room 717, Nongfeng Building, No.96 Dong San Huan Nan Lu, Chaoyang District, Beijing, 100122, P. R. China
Phone number: +86-10-59199389
Fax number: +86-10-59199391
Country introduction: Regulations on Safety of Agricultural Genetically Modified Organisms (hereafter referred to as the Regulations)was promulgated by Decree No. 304 of the State Council of the People’s Republic of China on May 23, 2001. Implementation Regulations on Safety Assessment of Agricultural Genetically Modified Organisms, Implementation Regulations on the Safety of Import of Agricultural Genetically Modified Organisms and Implementation Regulations on Labeling of Agricultural Genetically Modified Organisms are formulated by Ministry of Agriculture on January 5, 2002 in accordance with the Regulations. The State Council establishes a system of joint ministry conference for the safety administration of agricultural GMOs. The joint ministry conference for the safety administration of agricultural GMOs shall be composed of officials from relevant departments of agriculture, science and technology, environment protection, public health, foreign trade and economic cooperation, inspection and quarantine, and be responsible for the decision-making and coordination of major issues with respect to the safety administration of agricultural GMOs. According to Article 9 of the Regulations, a national biosafety committee (NBC) shall be established and in charge of safety assessment of agricultural GMOs. The NBC shall be composed of experts who are engaged in biological research, production, processing, inspection and quarantine with respect to agricultural GMOs, as well as experts in the fields of public health and environmental protection. The office term of the NBC shall be three years. Ministry of Agriculture is responsible for the nationwide supervision and administration of the safety of agricultural GMOs. The Ministry of Agriculture sets up an office for biosafety administration of agricultural GMOs(OBA), which will be in charge of the administration of the safety assessment of agricultural GMOs. OBA is Affiliated to the Department of Science, Technology and Education. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: office for biosafety administration of agricultural GMOs(OBA), the Department of Science, Technology and Education,MOA, P. R. China Tel:+86-10-59193059, Fax:+86-10-59193072, E-mail: [email protected]
| Name of product applicant: |
Bayer Korea Ltd. |
| Summary of application: |
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| Date of authorization: |
31/08/2005 |
| 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.): |
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| Summary of the safety assessment (food safety): |
Please see the link below(in Korean). |
| Upload: |
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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:
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