Food safety and quality
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OECD Unique Identifier details

ACS-BNØØ5-8xACS-BNØØ3-6
Commodity: Canola / Oilseed rape / Rape Seed
Traits: Glufosinate tolerance
Canada
Name of product applicant: Bayer CropScience Canada
Summary of application:
A novel hybridization system for canola (Brassica napus) has been developed by Plant Genetic Systems N.V. This system involves the use of two inbred parental lines. The first line (female) is male sterila and therefore does not produce pollen. The second line (male) codes for restoration of fertility. The hybrid plants resulting from the cross of these two lines are fully fertile and produce seed. Linked to this hybridization system is tolerance to the non-selective herbicide glufosinate ammonium, the active ingredient in Liberty® herbicide.

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Date of authorization: 12/03/1997
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:
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:
E-mail:
luc.bourbonniere@hc-sc.gc.ca
Organization/agency name (Full name):
Health Canada
Contact person name:
Luc Bourbonniere
Website:
Physical full address:
251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number:
613-957-1405
Fax number:
613-952-6400
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 (see Figure 1). 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 document 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:
Luc Bourbonniere, Section Head Novel Foods
China
Name of product applicant: Bayer Cropscience
Summary of application:

Genetically modified organism: ACS-BNØØ5-8 × ACS-BNØØ3-6  (MS8,RF3)  line of  Canola (Brassica napus L.) ; Exogenous gene:  barnase gene for male sterility, isolated from Bacillus amyloliquefaciens, barstar gene isolated from Bacillus amyloliquefaciens and bar gene, isolated from the common soil microorganism Streptomyces hygroscopicus;  Trait: Glufosinate ammonium herbicide tolerance and fertility restored; Transformation methods: Agrobacterium tumefaciens-mediated plant transformation; Safety level: Ⅱ

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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
Summary of the safety assessment:
Please see decision document uploaded
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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. 869-5-2007: Detection of Genetically Modified Plants and Derived Products Qualitative PCR Method for Herbicide-Tolerant Rapeseed MS8,RF3 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: 6/4/2007
E-mail:
fuzhongwen@agri.gov.cn
Organization/agency name (Full name):
Development Center for Science and Technology, Ministry of Agriculture
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: gmo@agri.gov.cn