Food safety and quality
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OECD Unique Identifier details

A 27Ø4-12
Commodity: Soyabean / Soybeans
Traits: Herbicide tolerance
Ghana
Name of product applicant: BASF South Africa on behalf of BASF Agricultural Solutions Seed US LLC
Summary of application:

The A2704-12 soybean event is modified by incorporating the pat gene into its genome. The modified plants produce the enzyme phosphinothricin acetyl-transferase (PAT), which confers tolerance to herbicides with glufosinate ammonium as an active ingredient. PAT acetylates and thereby detoxifies glufosinate. Other countries, in addition to South Africa, where this event has been authorised for direct use as food, feed, or for processing include Argentina (cultivation, food and feed), Brazil (cultivation, food and feed), Nigeria (food, feed and processing), and the United States of America (cultivation, food and feed) among others.


 
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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.): Decision
Risk Assessment
Summary of the safety assessment (food safety):
The TAC concludes that, based on the assessment of the soybean event A2704-12 approved for direct use as food, feed or for processing in the country of origin (South Africa) and 13 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. Taking these evaluations into account, TAC has no objection to the authorisation of genetically modified soybean (Glycine max) event A2704-12 with OECD unique identifier ACS-GMØØ5- 3 for direct use as food, feed or for processing in Ghana. TAC also recommends that the duration for this authorisation should be three years with subsequent renewals being administrative-based. The proposed three-year duration also aligns with the food product registration validity period stipulated by the Ghana Food and Drugs Authority (FDA).
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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: Decision
Risk Assessment
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Authorization expiration date (a blank field means there is no expiration date) JUNE 29, 2025
E-mail:
[email protected]
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
Ghana on the global BCH
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. 

Russian Federation
Name of product applicant: Bayer CropScience AG
Summary of application:

There were submitted (1) data enabling to identify the matter of research (species, variety, and the transformation event); (2) data on the initial parental organism and the donor organism for introduced genetic sequences;  (3) data on the genetic modification method, genetic construction, and the level of gene expression; (4) data on identification of GM soybean line A2704-12 (identification methods, protocol of analysis, description of primers, reference materials); (5) data on registration of the GM line  in other countries and the results of safety assessment which conducted for registration purposes of GMO in other countries.
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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.):
Summary of the safety assessment (food safety):
By all examined parameters, the data of complex safety assessment of glufosinate- tolerant transgenic soybean line A2704-12 attest to the absence of any toxic, genotoxic, immune system modulating, or allergenic effects in this soybean variety. Analysis of the biochemical composition of transgenic soybean line A2704-12 and the protein concentrate derived from it demonstrated its identity to the composition of conventional soybean. 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 A2704-12 to be used in the food industry and to be placed on the market without restrictions. More information is on P. 69-90 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:
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:
[email protected]
Organization/agency name (Full name):
FSBI «Institute of Nutrition» RAMS
Contact person name:
Nadezhda Tyshko
Website:
http://www.ion.ru
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
www.ion.ru
http://rospotrebnadzor.ru/
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