Commodity: |
Soyabean / Soybeans |
Traits: |
Herbicide tolerance |
Name of product applicant: |
BASF South Africa on behalf of BASF Agricultural Solutions Seed US LLC |
Summary of application: |
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Date of authorization: |
30/06/2022 |
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.): |
Risk Assessment
Decision
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Summary of the safety assessment (food safety): |
Findings showed that safety and nutritional assessments of the soybean event A5547-127approved in Argentina, Brazil, Nigeria, South Africa, USA, Australia, and European Union confirm the event is as safe as its conventional counterpart. The TAC also noted that there are other countries where similar approvals had been granted on the soybean event A5547-127 including Canada, Japan, Mexico, New Zealand, Republic of Korea, Viet Nam, Philippines, Costa Rica, Uruguay, and Colombia. These countries have also approved the soybean event A5547-127 for various purposes, including for cultivation, and for direct use as food, feed or for processing (FFP)
The TAC concludes that, based on the assessment of the soybean event A5547-127approved for direct use as food, feed or for processing in the country of origin (South Africa) and 16 other countries, there are no biosafety concerns with the event intended to be imported for direct use as food, feed and for processing in Ghana. |
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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: |
Risk Assessment
Decision
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Authorization expiration date (a blank field means there is no expiration date) |
JUNE 29, 2025 |
E-mail:
Organization/agency name (Full name): Ministry of Environment Science Technology and Inn
Contact person name: Eric Amaning Okoree
Website:
Physical full address: Ministries Accra
Phone number: 00233208163038
Fax number: 00233302688913/68866
Country introduction: The Ministry of Environment, Science, Technology and Innovation, is responsible for the regulation of all activities related to the management of the environment for the purpose of attaining sustainable development in line with the Millenium development goals. Consequently, the Ministry is responsible for the implementation of the Biosafety Law (Act 831) which came into force on 31 December 2011.
The Ministry imlemented the National Biosafety Authority in July 2015 to be responsible for all matters on rDNA-derived foods. The NBA receives, reviews and decides on all applications of this nature. Based on the type of application, the Act 831 constituted the Technical Advisory Committee to review the application and submit report to the Board of the NBA to make decision. Ghana has not yet carried out any rDNA-derived food safety assessment however, the NBA has approved confined field trials of rDNA-derived cotton, sweet potato, rice and cowpea. Currently, the National Biosafety Clearing House is undergoing maintenance, however the Ghana page on the Global Biosafety Clearing House has additional information that may be accessed through the following address: bch.cbd.int/about/countryprofile.shtml?country=gh
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: National Biosafety Authority, working with the Food and Drugs Authority as the Regulatory Agency for Food safety.
Name of product applicant: |
Bayer CropScience AG |
Summary of application: |
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Upload: |
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Date of authorization: |
15/10/2002 |
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.): |
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Summary of the safety assessment (food safety): |
By all examined parameters, the data of complex safety assessment of glufosinate-
tolerant transgenic soybean line A5547-127 attest to the absence of any
toxic, genotoxic, immune system modulating, or allergenic effects of this soybean
variety. Analysis of the biochemical composition of transgenic soybean
line A5547-127 and the protein concentrate derived from it showed its identity
to the composition of their conventional counterparts.
Based on the results of the studies, the State Sanitation Service of the
Russian Federation (Department of State Sanitation and Epidemiological
Inspectorate) granted the Registration Certificate which allows the transgenic
soybean line A5547-127 to be used in the food industry and placed on the
market without restrictions.
More information is on P. 90-108 of monograph ”Genetically Modified Food Sources. Safety Assessment and Control”, published by Elsevier Inc. Academic Press in 2013,
the uploaded file.
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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): FSBI «Institute of Nutrition» RAMS
Contact person name: Nadezhda Tyshko
Website:
Physical full address: 109240, Russia, Moscow, Ustinsky Proezd, 2/14
Phone number: +7(495)698-53-64
Fax number:
Country introduction: The development of the GMO safety assessment currently used in the Russian Federation started in 1995–1996. The methodological approaches to comprehensive complex medical and biological assessment of GMOs were developed in the Russian Federation with due regard for international and national experience as well as new scientific approaches based on the achievements of contemporary fundamental science: genomic and proteomic analysis, detection of DNA damage or mutagenic activity, identification of products of free-radical modifications of DNA or other sensitive biomarkers. GMO safety assessment is carried out for the state registration. Any novel food derived from plant GMO produced in Russia or imported into Russia for the first time is subject to the state registration . Guidance for safety assessment is specified in MU 2.3.2.2306-07 “Medico-Biological Safety Assessment of Plant Genetically Modified Organisms”. According to the accepted regulations,the human health assessment of a novel GMO to be placed on the domestic market includes the following: ■ Molecular assessment includes analysis of genetic construction, genetic modification method, and the gene expression level. ■ Technological assessment includes determination of organoleptic and functional properties, analysis of technological characteristics of the finished products. ■ Human health safety assessment includes several sections of required assessments: analysis of compositional equivalence and toxicological,genotoxicological, and allergological safety studies. ■ Methods for identification include qualitative and quantitative assay of GMO in food (studies targeted at determination of correspondence of these methods to those used in Russia in order to provide monitoring of use and labeling of GM food). The list and the scope of required studies is determined on the basis of analysis of information of the GMO submitted for registration; however, the above-mentioned studies are required. If significant changes in the GMO’s genome, proteome, or metabolome are shown, additional studies may be required to determine: biological value and absorbency reproductive effect; gonadotoxic, embryotoxic, teratotoxic effect; potential carcinogenic effect; lifetime, etc.
Useful links
Relevant documents
Stacked events: Russia follows the national Methodical Guidelines 2.3.2.3388-16 “Medical and biological safety assessment of genetically modified stack events of plant origin ”
Our position regarding GM stacks registration is very close to the EU approach.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Federal Research Centre of nutrition and biotechnology Viktor A. Tutelyan Ustinsky proezd, 2/14 109240 Moscow, RUSSIA E-mail: [email protected] Tel.:+7 495 698-53-60
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