Food safety and quality
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OECD Unique Identifier details

ACS-BNØØ5-8xACS-BNØØ3-6xMON-ØØØ73-7
Commodity: Canola / Oilseed rape / Rape Seed
Traits: Fertility restoration,Glufosinate tolerance,Glyphosate tolerance,Male sterility
Japan
Name of product applicant: Bayer Crop Science Ltd.
Summary of application:

Glufosinate and Glyphosate herbicide-tolerant, male-sterile and fertility-restored oilseed rape (Modified bar, modified cp4 epsps, modified gox v247, barnase, barstar, Brassica napus L.).

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Date of authorization: 02/03/2011
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:
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 Food Safety Commission of Japan (in Japanese)
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Authorization expiration date:
E-mail:
fscj-secretariat@cao.go.jp
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,GOJ
Contact person name:
Hirotoshi Maehara
Website:
Physical full address:
Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number:
81 3 6234 1074
Fax number:
81 3 3584 7392
Country introduction:
The safety assessment of foods and food additives produced by recombinant DNA techniques (hereafter GM foods) is mandatory under the Food Sanitation Law. The Ministry of Health, Labour, and Welfare (MHLW) receives application from Applicant and requests the Food Safety Commission of Japan (FSCJ) to evaluate the safety of GM foods, and the FSCJ evaluates the safety in terms of human health. Within the FSCJ, the Expert Committee of Genetically Modified Foods conducts safety assessments based on following standards and policies (1) Standards for the Safety Assessment of Genetically Modified Foods (2) Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants (3) Standards for the Safety Assessment of Food Additives Produced Using Genetically Modified Microorganisms (4) Policies Regarding the Safety Assessment of Highly Purified Non-Protein Food Additives including Amino Acids Produced Using Genetically Modified Microorganisms It is forbidden to import or sell genetically modified foods or food products made from such foods that have not undergone safety assessment. After FSCJ submits a notification to MHLW, MHLW gives notice on the Official Gazette.
Useful links
Relevant documents
Stacked events:
With regard to stacked events, FSC conducts the Safety Assessment of GM Foods based on the “Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants”
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: Bayer de México, S.A. de C.V.
Summary of application:

Canola (Brassica napus) con esterilidad masculina y fertilidad reconstituida, tolerante a los herbicidas glufosinato de amonio y glifosato.


Canola MS8 x RF3 x GT73


OECD: ACS-BNØØ5-8 x ACS-BNØØ3-6 X MON-ØØØ73-7


 


Usos propuestos:









Para ser procesado y usado en los alimentos de   consumo humano y animal, forraje y productos industriales en la misma forma   como los productos obtenidos con la canola convencional.



 


Descripción del producto de transformación:









La canola ACS-BNØØ5-8 x ACS-BNØØ3-6 x MON-ØØØ73-7   fue obtenida mediante cruzamiento convencional de los respectivos eventos   parentales. Contiene los siguientes elementos.



  •   Gen bar de Streptomyces   hygroscopicus que codifica para la proteína PAT, que le confiere   tolerancia al glufosinato de amonio.

  •   Gen barnasa de Bacillus   amyloquefaciens, que codifica para la enzima ribonucleasa barnasa   (RNAasa)

  •   Gen barstar de Bacillus   amyloquefaciens, que codifica para un inhibidor de la enzima barnasa   ribonucleasa

  •   Gen cp4 epsps, de Agrobacterium tumefaciens cepa CP4, que codifica   para la enzima EPSPS que le confiere tolerancia al glifosato.

  •   Gen goxv247, de Ochrobactrum   anthopi cepa LBAA que codifica para la enzima glifosato oxidasa, que   degrada el glifosato en AMPA y glioxilato.


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Date of authorization: 23/09/2011
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:
UI OECD: ACS-BNØØ5-8 x ACS-BNØØ3-6 X MON-ØØØ73-7 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.
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:
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:

La Comisión Intersecretarial de Bioseguridad de los Organismos Genéticamente Modificados está integrada por los titulares de las Secretarías de Medio Ambiente y Recursos Naturales Renovables (SEMARNAT), Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación (SAGARPA); Salud (SS); Hacienda y Crédito Público (SHCP); Economía (SE) y Educación Pública (SEP); así como por el Director General del Consejo Nacional de Ciencia y Tecnología (CONACYT).

La presidencia de la Comisión es rotatoria por periodos de dos años, entre los Secretarios de Salud, SAGARPA y SEMARNAT ya que son las Secretarías con un mayor ámbito de competencia en relación con el uso seguro de los Organismos Genéticamente Modificados (OGMs).

Ley de Bioseguridad de Organismos Genéticamente Modificados, estipula que para su implementación la Comisión debe coordinar las acciones pertinentes con las instancias del Gobierno para cumplir su objetivo.

La CIBIOGEM, cuenta con grupos de apoyo que son sus órganos técnicos y consultivos: Comité Técnico, Consejo Consultivo Científico, Consejo Consultivo Mixto y la Secretaría Ejecutiva.

¿Cuál es el propósito de la CIBIOGEM?

Coordinar las políticas de la administración pública federal referentes a diferentes actividades relacionadas con OGMs como son: la producción, importación, exportación, movilización, transporte, siembra, consumo y, en general uso y aprovechamiento de OGMs.

 

-Courtesy Translation-

The Intersecretarial Commission on Biosafety of Genetically Modified Organisms is made up of the heads of the Secreataries of Health (SSA); Agriculture, Livestock, Rural, Development, Fisheries and Food (SAGARPA); Environment and Natural Resources (SEMARNAT); Finance and Public Credit (SHCP); Economy (SE); Public Education, and the General Director of the National Council of Science and Technology.

The chair of the Commission rotates every two years among the Secretaries of Health, SEMARNAT and SAGARPA, the three entities most directly involved in policies concerning the use and biosafety of Genetically Modified Organisms (GMOs).

The Law on Biosafety of Genetically Modified Organisms states that the Commission aims to promote and coordinate the actions of Government agencies. CIBIOGEM receives support from the Executive Secretariat of CIBIOGEM, the Technical Committee, the Scientific Advisory Board and the Joint Advisory Council.

What is the purpose of the CIBIOGEM?

To coordinate the policies and federal regulation of activities related to Genetically Modified Organisms (GMOs) such as: production, import, export, mobilization, transportation, release into the environment, consumption, and general use of GMOs.

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: marriola@cofepris.gob.mx