Food safety and quality
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OECD Unique Identifier details

MON 81Ø
Commodity: Corn / Maize
Traits: Insect resistance
Antigua and Barbuda
Name of product applicant: Monsanto Company
Summary of application:

This represents a food and feed safety assessment conducted by Antigua and Barbuda for imported products likely to contain insect-resistant maize containing the event, MON810.

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Date of authorization: 24/11/2021
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.):
Summary of the safety assessment (food safety):
Based on an assessment of available information from developed and developing countries, Maize variety MON810 appears to be as safe as its non-genetically modified counterparts. The allergenicity and toxicity of MON810 has not been increased nor has its nutritional content been significantly changed as a result of the genetic modification process, when compared with conventional, non-GM maize varieties.
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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:
Not applicable
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)
E-mail:
Organization/agency name (Full name):
Plant Protection - Department of Agriculture
Contact person name:
Dr. Janil Gore-Francis
Website:
Physical full address:
Central Cotton Station, Friars Hill Road, St. John's, Antigua
Phone number:
+1 268 764-1255
Fax number:
+1 268 562-1923
Country introduction:

Antigua and Barbuda is a two-island nation which is located in the Eastern Caribbean.  The population of under 100,000 - with approximately 1600 living in Barbuda just prior to the September 2017 devastation by Hurricane Irma - is largely of African descent.  The economy is largely service oriented, with trade imports contributing approximately US$450 million, and exports amounting to about US$40 million.

The Convention on Biological Diversity and the Cartagena Protocol on Biosafety were ratified by Antigua and Barbuda on December 29, 1993 and December 9, 2003, respectively.  The Nagoya Protocol on Access and Benefit Sharing was ratified on March 12, 2017.

Antigua and Barbuda has, since 2002, been actively involved in assessing, developing and implementing a national biosafety framework for the country.  Stakeholder consultations, training of regulators, development of national draft legislation, regulatory attachments and other capacity building activities constitute the main efforts in the process.  In recent times, through a UNEP-GEF funded regional project, several activities were undertaken at the regional level with a view to harmonise the issue of biosafety across the Caribbean region.

Food and feed safety assessment capacity building stakeholder training activities were conducted in the first quarter of 2018 to assist te country in the process going forward.

Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

In Antigua and Barbuda, food safety assessments is a shared activity amongst several competent authorities.  The details are as follows:

 

ANTIGUA AND BARBUDA BUREAU OF STANDARDS [CODEX Focal Point], Ministry of Foreign Affairs, Trade & Immigration; Old Parham Road; St. John's, Antigua; Email: [email protected]; website: www.abbs.gov.ag

Contact persons:

1.Mrs. Dianne Lalla-Rodrigues - Director

2. Mrs. Solange Baptiste - Manager of Information Services

 

DEPARTMENT OF ANALYTICAL SERVICES [Biosafety Testing Laboratory]; Ministry of Agriculture, Fisheries & Barbuda Affairs, Dunbars, Friars Hill Road, St. John's, Antigua; Email - [email protected]; Tel. +1(268)462-6281, +1(268)764-8338

Contact person

Dr. Linroy Christian - Director of Analytical Services

 

DEPARTMENT OF THE ENVIRONMENT [Focal Point]; Ministry of Health, Wellness & the Environment; No. 1 Victoria Park, Botanical Gardens, Sir Sidney Walling Highway, St. John's, Antigua; Email - [email protected]; Tel. +1(268)462-4625; Website - www.environment.gov.ag

Contact person:

Ambassador Diann Black-Layne - Director

 

PLANT PROTECTION [Biosafety Clearing House]; Department of Agriculture; Ministry of Agriculture, Fisheries & Barbuda Affairs; Central Cotton Station Building, Friars Hill Road, St. John's, Antigua; Tel. +1(268)562-2776, +1(268)764-1255, +1(268)764-7378; Fax. +1(268)562-1923; Email: [email protected]; Website - www.agriculture.gov.ag/index.php/plant-protection 

Contact persons:

1. Dr. Janil Gore-Francis - Chief Plant Protection Officer

2. Mrs. Kishma Primus-Ormond - Senior Plant Protection Officer

 

VETERINARY & LIVESTOCK DIVISION [Animal Health]; Ministry of Agriculture, Fisheries & Barbuda Affairs, P.O. Box 1282, St. John's, Antigua; Tel. +1(268)562-7592, +1(268)764-1263; Email - [email protected]

Contact person:

Dr. Tubal Edwards - Chief Veterinary Officer

 

 

Indonesia
Name of product applicant: Monsanto Indonesia (PT. Branita Sandhini)
Summary of application:

Maize MON810 has been modified to be tolerant to the herbicide glyphosate through the expression of the cp4 epsps gene derived from the common soil bacterium Agrobacterium sp. strain CP4 and resistant to the Lepidopteran insect through the expression of cry1Ab gene.

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Date of authorization: 05/11/2018
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):
Please see the attachment (in Indonesian)
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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:
Organization/agency name (Full name):
Indonesian Agency for Agricultural Research and De
Contact person name:
Sustiprijatno
Website:
Physical full address:
BB Biogen Jl Tentara Pelajar 3A Bogor 16111 Indonesia
Phone number:
+622518333440
Fax number:
+622518334420
Country introduction:
  1. Indonesia has  ratified Protocol  on Biosafety to the  Convention on Biological Diversity (CBD) through the Indonesian Law No. 21 / 2004.  In the implementation, biosafety  assessment for GM products, based on Goverment Regulation Number 21 /2005, Indonesia  has regulated GM products on  several items including : product kinds and requrements, research and developement,  product importation,  product assessment, release and distribution, supervision and monitoring, and institution and financing. We have also Law for food  No. 18 /2012 which also consists of regulation for GM food.
  2. Indonesia already have procedure /application on GMO  biosafety assessment and National Authorized Institution who conducting  the biosafety  assessment .  Each GM food  should have authorization from Goverment  before it can be released and distributed. An application for authorisation for new  GM food  should be submited to  Biosafety Commision  through related Ministry or authorised Non Departement Goverment Agency (LPND) . Biosafety Commision, then sends the application to the National Agency for Drug and Food Control (Badan POM) for technical team to evaluate  the GM food safety.  The recommendation by technical team will be sent  back  to Biosafety Commision. The recommendation and GM Food safety certificate will be released by Biosafety Commision to the applicant through  related ministry or LPND.  
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

National Agency of Food and Drug Control (BPOM): http://www.pom.go.id/new/home/en

Russian Federation
Name of product applicant: Monsanto Company
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 maize line MON810 (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: 12/07/2000
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 transgenic maize line MON 810 resistant to European corn borer attest to the absence of any toxic, genotoxic, immune system modulating, or allergenic effects of this maize line. By chemical composition, transgenic maize line MON 810 was identical to conventional maize. 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 maize line MON 810 to be used in the food industry and placed on the market without restrictions. More information is on P. 142-158 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:
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