Food safety and quality: OECD Unique Identifier details

European Union
Name of product applicant:	Monsanto Europe S.A.
Summary of application:	Genetically modified soybean MON-877Ø8-9 expresses the DMO (dicamba mono-oxygenase) proteins which confer tolerance to dicamba-based herbicides. Products: 1) Foods and food ingredients containing, consisting of, or produced from MON-877Ø8-9 soybean 2) Feed containing, consisting or produced from MON-877Ø8-9 soybean 3) Products other than food and feed containing or consisting of MON-877Ø8-9 soybean for the same uses as any other soybean with the exception of cultivation
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Date of authorization:	24/04/2015
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.):	EU Register of authorised GMOs
Summary of the safety assessment (food safety):	Please see the EU relevant links below.
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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:	Method for detection: Event specific real-time PCR based method for the quantification of soybean MON-877Ø8-9. Validated on by the EU Reference Laboratory established under Regulation (EC) No 1829/2003. Reference material: AOCS 0311-A and AOCS 0906-A are accessible via the American Oil Chemists Society. Relevant links are provided below.
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:	Opinion of the European Food Safety Authority Method for detection Reference material
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Authorization expiration date (a blank field means there is no expiration date)	26/04/2025

E-mail:

[email protected]

Organization/agency name (Full name):

European Union

Contact person name:

Alexandre Huchelmann

Website:

http://www.europa.eu

Physical full address:

European Commission B232 04/106 1047 Brussels

Phone number:

3222954092

Fax number:

Country introduction:

The process for authorising a new GMO is based on the EU regulation on GM food and feed (1829/2003). An application for authorising food or feed consisting of or made from a GMO must be submitted to the national authorities. The national authority then sends the application to the European Food Safety Agency (EFSA) for a risk assessment. EFSA then makes the application summary available to the public. No matter where in the EU the company applies, EFSA assesses the risks the GMO presents for the environment, human health and animal safety. If the application covers cultivation, EFSA delegates the environmental risk assessment to an EU country which sends EFSA its risk assessment report. After performing the risk assessment, EFSA submits its scientific opinion to the European Commission and to EU countries. The opinion is made available to the public, except for certain confidential aspects. Once EFSA publishes its risk assessment, the public has 30 days to comment on the Commission website for applications under Reg. 1829/2003, and on the Joint Research Centre website on the assessment report of the "lead" EU country for applications under Directive 2001/18. Within 3 months of receiving EFSA's opinion, the Commission grants or refuses the authorisation in a proposal. If it differs from EFSA’s opinion, it must explain why. National representatives approve the Commission’s proposal by qualified majority in: (1) The Standing Committee on the Food Chain and Animal Health if the application was submitted under Reg. 1829/2003; (2) The Regulatory Committee under Directive 2001/18/EC if the application was submitted under Dir. 2001/18. The proposal is adopted if the Committee agrees with it. If there is no opinion, the Commission may summon an Appeal Committee where EU countries can adopt or reject the proposal. If the Appeal Committee makes no decision, the Commission may adopt its proposal. Authorisations are valid for 10 years (renewable).

Useful links

European Commission – EU Register of authorised GMOs

European Food Safety Authority (EFSA) – GMO Panel

European Commission – Authorisation procedure

Relevant documents

Stacked events:

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Australia
Name of product applicant:	Monsanto Australia Ltd
Summary of application:	A genetically modified (GM) soybean line, MON87708 has been developed that provides tolerance to the herbicide dicamba. This modification will provide soybean growers with a broader weed management strategy. Tolerance to dicamba is achieved through expression of the enzyme dicamba monooxygenase (DMO) encoded by the dmo gene derived from the common soil bacterium Stenotrophomonas maltophilia. The DMO protein has not previously been assessed by FSANZ. It is anticipated that soybean plants containing event MON87708 may be grown in the United States of America and Canada subject to approval. There is no plan to grow the line in Australia or New Zealand.
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Date of authorization:	24/05/2012
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 (food safety):
Upload:	A1063 GM Soybean MON87708 AppR SD1 Safety Assess.pdf
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:	Application A1063 - Food derived from Herbicide-tolerant Soybean MON87708
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Authorization expiration date (a blank field means there is no expiration date)

E-mail:

[email protected]

Organization/agency name (Full name):

Food Standards Australia New Zealand

Contact person name:

Website:

http://www.foodstandards.gov.au

Physical full address:

Level 4, 15 Lancaster Place, Majura Park ACT 2609, Australia

Phone number:

+61 2 6271 2222

Fax number:

+61 2 6271 2278

Country introduction:

Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 115 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 10 staff) is located in Wellington on the North Island.

Useful links

Federal Register of Legislation (Schedule 26)

Federal Register of Legislation (Std 1.5.2)

GM current applications and approvals

Relevant documents

Application Handbook as at 1 March 2016.pdf

Stacked events:

FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)

No separate approval or safety assessment is necessary for foods derived from a stacked GM line that is the result of traditional breeding between a number of GM parent lines for which food has already been approved. Food from the parent lines must be listed in the Australia New Zealand Food Standards Code. The parent lines may contain any number of different genes. If food from any of the GM parent lines has not been approved, then a full pre-market safety assessment of food from the stacked line must be undertaken.

No separate approval is required for food derived from a line that is the product of a GM line, for which food has been approved, crossed traditionally with a non-GM line.

Where a single line containing a number of genes has been produced as a result of direct gene technology methods (rather than traditional crossing) then food derived from the line must undergo a full pre-market safety assessment before approval can be given

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)

Brazil
Name of product applicant:	Monsanto do Brasil Ltda
Summary of application:	Commercial release of soybean Genetically modified for dicamba tolerance MON87708.
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Date of authorization:	08/12/2016
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.):	ISAAA
Summary of the safety assessment (food safety):	1 - No risk of the MON 87708 event was identified as a weed after the Process, the insertion and expression of the new genetic Metabolic alteration was observed in plants; 2 - There was also no higher incidence of disease or damage when MON 87708 Compared to conventional soybeans. The agronomic characteristics also did not reveal differences that Could indicate that MON 87708 is more susceptible to disease; 3- Based on the evaluation of the gene product, donor organism, chemical composition, interactions Environmental characteristics, pollen characteristics, exposure of MON 87708 soybean without causing adverse Non-target organisms; 4 - MON 87708 soy does not cause an increased risk of gene flow or gene introgression Inserted for other varieties; 5. That the possibility of horizontal gene transfer of the new material inserted into the MON 87708 soybean is extremely low, therefore, an increase in disease, damage, including The appearance of new lines more aggressive to the environment, human and animal use. 7- MON 87708 soy is approved in the USA (2015), Canada (2012) and Japan (2012 in Japan For open field cultivation) for planting, human and animal use (http://www.isaaa.org - updated in 10 August 2016). Industrialized products containing the MON 87708 soybean have already been Countries such as the USA, Europe, Australia, New Zealand, Mexico, Canada, South, Taiwan, Japan and the Philippines for human and animal consumption.
Upload:	MON87708.pdf
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:	molecular traditional methods
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:	CTNBio
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Authorization expiration date (a blank field means there is no expiration date)	not aplicable

E-mail:

[email protected]

Organization/agency name (Full name):

National Biosafety Technical Commission

Contact person name:

Paulo Augusto Viana Barroso

Website:

http://www.ctnbio.gov.br

Physical full address:

SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF

Phone number:

556120335087

Fax number:

Country introduction:

Brazil had the first biosafety law approved in 1995. After the identification of the need to improve the biosafety system of Brazilian genetically modified organisms, a new law was published. The Law 11.105 / 05 establishes a technical committee dedicated to the analysis of the safety aspects of genetically modified organisms and a council of ministers that is dedicated to the analysis of the socioeconomic aspects of the commercial release of genetically modified organisms. In this context, Brazil already has several commercial products that involve genetically modified organisms (plants, human and veterinary vaccines, microorganisms for fuel production) and products derived from new genetic modification techniques.

Useful links

Brazilian National Biosafety Commission – CTNBio

Relevant documents

Stacked events:

At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Dr. Paulo Augusto Viana Barroso (President of national Biosafety Commission)

Canada
Name of product applicant:	Monsanto Canada Inc.
Summary of application:	Monsanto Canada developed Dicamba Tolerant Soybean MON 87708 by modifying a proprietary, commercial soybean variety (A3525) using recombinant DNA techniques to introduce the dicamba mono-oxygenase (dmo) coding sequence derived from the bacterium Stenotrophomonas maltophilia. The sequence codes for the DMO protein which catalyzes the demethylation of the herbicide Dicamba to the non-herbicidal compounds 3,6-dicholorosalicylic acid (DCSA) and formaldehyde.
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Date of authorization:	12/10/2012
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 (food safety):	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 (a blank field means there is no expiration date)

E-mail:

[email protected]

Organization/agency name (Full name):

Health Canada

Contact person name:

Neil Strand

Website:

http://www.hc-sc.gc.ca/fn-an/gmf-agm/index-eng.php

Physical full address:

251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1

Phone number:

613-946-1317

Fax number:

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.

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 guidance document (i.e. Canadian Guidelines for the Safety Assessment of Novel Foods) 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

Health Canada Novel Foods Webpage

Canadian Guidelines for the Safety Assessment of Novel Foods

CFIA's Novel Feeds Webpage

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:

Neil Strand, Section Head of Novel Foods

Colombia
Name of product applicant:	Compañia Agricola S.A.S
Summary of application:	Authorization of the genetically modified maize MON87708 olerant to herbicide Dicamba
Upload:	Resolucion 1259 de 2015.pdf
Date of authorization:	22/04/2015
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):	Based on the risk assessment, it can be concluded that the event shows the same risks as its conventional counterpart. Therefore the National Technical Biosafety Committee for GMO use exclusively in Health and human consumption (CTNSalud) recommends its authorization.
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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):

Ministerio de salud y proteccion social

Contact person name:

Daniel Rubio

Website:

http://[email protected]

Physical full address:

Carrera 13 No. 32- 76 piso 12, Bogotá

Phone number:

330 5000 ext 1256

Fax number:

Country introduction:

The 4525 decree of 2005, established the Ministry of Health and Social Protection as the competent authority for GMO for health and food purposes and creates the National Biosafety Technical Committee for GMO's used in health and food purposes (CTNSalud).

The CTNSalud is composed by the Ministry of Health and Social Protection, the National Food and Drug Surveillance Institute (INVIMA) and the Technology and Innovation Administrative Department (COLCIENCIAS). This committee is responsible for the assesment of risk assessments; to inquire for any additional information; assessment of any measurements in accordance to the Cartagena Protocol; and the recommendation for the authorization of GMO for health or food purposes.

Useful links

Relevant documents

Stacked events:

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Colombia
Name of product applicant:	Compañía Agrícola S.A.S
Summary of application:	GMO authorization for MON88708 soy as food for direct use or processing.
Upload:	1- Resolución 2020032882 de 2020.pdf
Date of authorization:	30/09/2020
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):	Based on the risk assessment, it can be concluded that the event shows the same risks as its conventional counterpart. Therefore, the National Technical Committee for GMO use exclusively in health and human consumption (CTNSalud) recommends its authorization.
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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):

Ministerio de salud y proteccion social

Contact person name:

Daniel Rubio

Website:

http://[email protected]

Physical full address:

Carrera 13 No. 32- 76 piso 12, Bogotá

Phone number:

330 5000 ext 1256

Fax number:

Country introduction:

Useful links

Relevant documents

Stacked events:

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Ghana
Name of product applicant:	Bayer West-Central Africa S.A.
Summary of application:	Bayer West-Central Africa S.A. has applied requesting for authorisation of genetically modified Soybean (Glycine max) Event MON 87708 with the OECD unique identifier MON-877Ø8-9 for direct use as food, feed or for processing in Ghana. The Soybean Event MON 87708 expresses dmo gene which encodes DMO protein that confers tolerance to dicamba herbicide. Dicamba Tolerant Soybean MON 87708 has been reviewed and approved for diverse uses (food, feed or for processing and/or cultivation) in several countries.
Upload:	12_Decision Document on Genetically Modified Organism BAYER.pdf
Date of authorization:	15/02/2024
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):	The Board of the NBA considered the recommendations from the Technical Advisory Committee (TAC) following the Committee's thorough evaluation of the applications submitted by the applicant using information available on: i. the Biosafety Clearing House (BCH), which is a mechanism set up by the Cartagena Protocol on Biosafety to facilitate the exchange of information on Living Modified Organisms (LMOs) and assist the Parties to better comply with their obligations under the Protocol and to which Ghana is a Party, ii. the Organisation for Economic Co-operation and Development (OECD) Biotrack Product Database, iii. the Food and Agriculture Organisation of the United Nations (FAO) genetically modified foods platform. The following considerations were evaluated: a. development of the modified events including the rnolecular biology data that characterizes the genetic change; b. proximate analyses; major constituents (fats, proteins, carbohydrates) and minor constituents (minerals and vitamins); c. composition of, and nutritional information (including anti-nutrients) on the GM products compared to their conventional counterparts; d. the potential for causing allergic reactions; e. microbiological and chemical safety of the event(s); f. the potential for production of new toxins in the event(s); and, g. the potential for any unintended or secondary effects;
Upload:	MON 87708 (DT soy) FINAL VERSION.docx
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:
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Authorization expiration date (a blank field means there is no expiration date)	3 years

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.

Indonesia
Name of product applicant:	Monsanto Indonesia (PT. Branita Sandhini
Summary of application:	Genetically modified soybean MON-877Ø8-9 expresses the DMO (dicamba mono-oxygenase) proteins which confer tolerance to dicamba-based herbicides
Upload:	87708.pdf
Date of authorization:	13/10/2015
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 refer to the document (in Indonesian)
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 (a blank field means there is no expiration date)

E-mail:

[email protected]

Organization/agency name (Full name):

Indonesian Agency for Agricultural Research and De

Contact person name:

Sustiprijatno

Website:

http://www.litbang.pertanian.go.id

Physical full address:

BB Biogen Jl Tentara Pelajar 3A Bogor 16111 Indonesia

Phone number:

+622518333440

Fax number:

+622518334420

Country introduction:

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.
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

Indonesia Biosafety Clearing House

National Agency of Drug and Food Control

Indonesian Center for Agricultural Biotechnology and Genetic Resources Research and Development (in Indonesian)

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

Indonesia
Name of product applicant:	Monsanto Indonesia (PT. Branita Sandhini)
Summary of application:	A genetically modified (GM) soybean line MON-87708 has been developed by Monsanto Company to be tolerant to dicamba-based herbicide through the expression of dmo gene to produce dicamba mono-oxygenase enzyme and tolerant to glyphosate herbicide is achieved through expression of the enzyme 5-enolpyruvyl-3-shikimatephosphate synthase (CP4 EPSPS).
Upload:	17. Kedelai PRG event MON 87708.pdf
Date of authorization:	13/10/2015
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 attached documents (in Indonesian)
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 (a blank field means there is no expiration date)

E-mail:

[email protected]

Organization/agency name (Full name):

Indonesian Agency for Agricultural Research and De

Contact person name:

Sustiprijatno

Website:

http://www.litbang.pertanian.go.id

Physical full address:

BB Biogen Jl Tentara Pelajar 3A Bogor 16111 Indonesia

Phone number:

+622518333440

Fax number:

+622518334420

Country introduction:

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.
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

Indonesia Biosafety Clearing House

National Agency of Drug and Food Control

Indonesian Center for Agricultural Biotechnology and Genetic Resources Research and Development (in Indonesian)

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

Iran
Name of product applicant:	Monsanto
Summary of application:	MON 87708 soybean line was developed as a marker-free LMO to exhibit tolerance to dicamba (3,6-dichloro-2-methoxybenzoic acid) herbicide.
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Date of authorization:	28/01/2019
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):	Competent National Authority: Ministry of Health and Medical Education- Food & Drug Administration. Risk Assessment file is uploaded. https://bch.cbd.int/en/database/RA/BCH-RA-IR-115205/1
Upload:	RA-MON-87708-9.pdf
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):

ABRII

Contact person name:

Gholamreza Salehi Jouzani

Website:

http://microbial.abrii.ac.ir/en/ShowMember/31/Gholamreza-SalehiJouzani

Physical full address:

Agricultural Biotechnology Research Institute of Iran (ABRII), Mahdasht Road, 31535-1897, Karaj, Iran

Phone number:

0098(26)32701132

Fax number:

0098(26)32701132

Country introduction:

Iran has ratified Cartagena Protocol on Biosafety in 2003. The National Biosafety Law has also been ratified in 2009. The regulations for the National Biosafety Law have been prepared and approved during last ten years. All these laws and regulations deal with Living GMOs (LMOs) and there is no Law for the regulation of the non-living GMOs. All these laws and regulations are accessible at: http://bch.cbd.int/database/results?searchid=622770. Codex principles for the risk analysis of foods derived from modern biotechnology and other guidelines such as the Codex guidelines for the conduct of food safety assessment of foods produced using recombinant-DNA plants and microorganisms are widely accepted and used.

The process for authorization of new LMO release includes comprehensive risk assessment and management analysis. Ministry of Agriculture (Jihade Keshavarzi) is responsible for approval of the release, import, export, transit and use of Agricultural Related LMOs. The requests should be forwarded to: a [email protected]; with a CC to National Focal Point: [email protected]. Cartagena Protocol on Biosafety National Focal Point is in charge of all liaison affairs related to the Cartagena Protocol on Biosafety and acts as the contact point for the communications received. The Ministry of Health and Medical Education is in charge with the approval of all LMOs related to food and medicine. Environmental Protection Organization is in charge with the environmental release of LMOs in the wild nature and/or related to the wild organisms. Detailed procedure for authorization of GM food and feed is under preparation.

Useful links

Laws and Regulations- Iran BCH

Decisions- Iran BCH

Risk Assessments- Iran BCH

Relevant documents

Stacked events:

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Agricultural Jihad Ministry

Tehran, Tehran

Iran (Islamic Republic of)

Phone:	+98-21-64583301
Fax:	+98-21-88947075
Email:	[email protected]
Url:	http://www.maj.ir

Ministry of Health and Medical Education- Food & Drug Administration

Food and Drug Administration, Fakhrerazi St., Enghelab Ave.

Tehran

Iran (Islamic Republic of), 1314715311

Phone:	009821-61927130
Fax:	009821-66405570
Email:	[email protected],[email protected]
Url:	http://fda.behdasht.gov.ir/

Japan
Name of product applicant:	Monsanto Japan Ltd.
Summary of application:	Soybean line MON87708 has been genetially modified to be tolerant to dicamba herbicide (modified dmo, Glycine max (L.) Merr.).
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Date of authorization:	03/10/2013
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.):	OECD BioTrack Product Database
Summary of the safety assessment (food safety):	Please see the links below (in Japanese).
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:	Food safety assessment performed by Food Safety Commission of Japan (in Japanese), Food Food safety assessment performed by Food Safety Commission of Japan (in Japanese), Feed
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Authorization expiration date (a blank field means there is no expiration date)

E-mail:

[email protected]

Organization/agency name (Full name):

Food Safety Commission Secretariat,Cabinet Office,

Contact person name:

Kojiro Yokonuma

Website:

http://www.fsc.go.jp/

Physical full address:

Akasaka 5-2-20 Minato Ward,Tokyo,Japan

Phone number:

81 3 6234 1122

Fax number:

81 3 3584 7392

Country introduction:

Safety assessments of GM foods are mandatory under the Food Sanitation Law in Japan. The Ministry of Health, Labour, and Welfare (MHLW) legally imposes safety assessments of GM foods so that those that have not undergone safety assessments would not be distributed in the country. MHLW receives application and requests the Food Safety COmmission of Japan (FSCJ) to evaluate the safety of GM foods in terms of human health. Safety assessments are carried out by FSCJ.

Useful links

Food Safety Commission of Japan, Genetically Modified Food/Feed

Food Safety Commission of Japan, Risk Assessment Report (Genetically Modified Food)

Ministry of Health, Labour and Welfare / Foods Produced by Recombinant DNA Techniques

Relevant documents

Stacked events:

With regard to stacked events, FSCJ conducts the safety assessment of GM food based on the “Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants”.

Even if single events that are stacked have already approved, some products will be considered as new products and some will not.

Please refer to Article 5 and 6 of the MHLW’s notice, which is available at the following URL, for the details.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000053519.pdf

Article 6 was modified in 2014, and the modified version is available at the following URL.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000049695.pdf

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)

Malaysia
Name of product applicant:	Monsanto Malaysia Sdn. Bhd.
Summary of application:	Please refer to the NBB Decision Document
Upload:	NBB Decision Monsanto MON87708 soybean.pdf
Date of authorization:	10/12/2019
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.):	Department of Biosafety Malaysia CBD Biosafety Clearing House
Summary of the safety assessment (food safety):	Please refer to the Risk Assessment Report
Upload:	GMAC Malaysia RA Report MON 87708 soybean.pdf
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):

Department of Biosafety Malaysia

Contact person name:

Dr. Anita Anthonysamy

Website:

http://www.biosafety.gov.my

Physical full address:

Department of Biosafety, Ministry of Natural Resources, Environment and Climate Change Level 4, Block F11, Complex F Lebuh Perdana Timur, Precinct 1 62000 Putrajaya, Malaysia

Phone number:

+60380917322

Fax number:

+60380917371

Country introduction:

GM food safety assessment is a requirement by law under the Biosafety Act 2007 in Malaysia. The National Biosafety Board reviews and makes decisions on events based on a scientific/technical risk assessment, policy considerations as well as public input. The decisions and its related documents made are publicly available through the Malaysian Department of Biosafety Website and the Convention of Biological Diversity Biosafety Clearing House.

Useful links

Department of Biosafety Malaysia

CBD Biosafety Clearing House

Relevant documents

Stacked events:

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Department of Biosafety, Ministry of Natural Resources, Environment and Climate Change Level 4, Block F11, Complex F Lebuh Perdana Timur, Precinct 1 62000 Putrajaya, Malaysia. Email: [email protected]. Url: www. biosafety.gov.my

Food Safety and Quality Division, Ministry of Health, Level 4, Menara Prisma, No. 26, Persiaran Perdana, Putrajaya, Malaysia, 62675. Phone: +603 88850797 Fax: +603 88850790 Email: [email protected]

Mexico
Name of product applicant:	Monsanto Comercial, S.A. de C.V.
Summary of application:	Authorization by COFEPRIS: 108 Soybean line MON87708 has been genetially modified to be tolerant to dicamba herbicide (modified dmo, Glycine max (L.) Merr.).
Upload:	108.pdf
Date of authorization:	06/07/2012
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):	UI OECD: MON-877Ø8-9 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 (a blank field means there is no expiration date)

E-mail:

[email protected]

Organization/agency name (Full name):

CIBIOGEM

Contact person name:

Dra. Consuelo López López

Website:

https://conacyt.mx/cibiogem/cibiogem

Physical full address:

San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.

Phone number:

+52 (55) 53227700

Fax number:

Country introduction:

México ha buscado garantizar la inocuidad de los productos biotecnológicos para el uso y consumo de su población.

Desde 1984 el artículo 282 bis 1 de la Ley General de Salud, contempló que la Secretaría de Salud debería regular aquellos productos biotecnológicos, o sus derivados, destinados al uso o consumo humano.

En un inicio, con fundamento en este artículo, la Secretaria de Salud evaluó la inocuidad alimentaria de productos biotecnológicos, para su comercialización con fines de uso o consumo humano. A partir de 2005, con la entrada en vigor de la Ley de Bioseguridad de Organismos Genéticamente Modificados (LBOGM), se realizó la adecuación de la regulación para dar lugar a la Autorización que es el acto administrativo mediante el cual la Secretaría de Salud, a través de la Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), autoriza Organismos Genéticamente Modificados (OGMs), a efecto de que se pueda realizar su comercialización, así como su utilización con finalidades de Salud Pública o de Biorremediación.

Las facultades que corresponden a la Secretaría de Salud se estipulan en el artículo 16 de la LBOGM y lo relativo a la Autorizaciones se describe en los artículos 91 al 98 de dicha Ley.

Quienes pretendan obtener una Autorización para Comercialización e Importación de OGMs deben presentar ante COFEPRIS, una solicitud por escrito acompañada de la información a que se refiere los artículos 23 al 32 del Reglamento de la Ley de Bioseguridad de OGMs.

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf

Courtesy translation

Mexico has sought to guarantee the safety of biotechnological products the use and consumption of its population. Since 1984, article 282 bis 1 from the General Law of Health, considered that the Secretary of Health should regulate those biotechnological products, or their derivatives, intended for food and feed use. Initially, the Secretary of Health evaluated the food safety of biotechnological products, based on this article, for commercialization with purposes of food, feed and processing. Subsequently in 2005, with the entry into force of the Law on Biosafety of Genetically Modified Organisms (LBOGM), the regulation was adapted to give rise to the Authorization, which is the administrative act through which the Secretary of Health, by means of the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), authorizes Genetically Modified Organisms (GMOs), to their commercialization, as well as their use for purposes of public health or bioremediation.

The faculties that correspond to the Secretary of Health are stipulated in Article 16 of the LBOGM and what is related to the Authorizations is described in Articles 91 to 98 of this Law. Those who seek to obtain an Authorization for GMOs merchandising and importation, must present to COFEPRIS, a written request accompanied by the information referred into articles 23 to 32 of the Regulation of the Law on Biosafety of Genetically Modified Organisms.

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf

Useful links

Comisión Intersecretarial de Bioseguridad de los Organismos Genéticamente Modificados

Sistema Nacional de Información

Relevant documents

Reglamento de la Ley de Bioseguridad de los Organismos Genéticamente Modificados.pdf

Expediente científico sobre el glifosato y los cultivos GM.pdf

Stacked events:

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Secretaría de Salud / Teléfono: +52 55 5080 5200 / Correo electrónico: [email protected]%20

New Zealand
Name of product applicant:	Monsanto Australia Ltd
Summary of application:	A genetically modified (GM) soybean line, MON87708 has been developed that provides tolerance to the herbicide dicamba. This modification will provide soybean growers with a broader weed management strategy. Tolerance to dicamba is achieved through expression of the enzyme dicamba monooxygenase (DMO) encoded by the dmo gene derived from the common soil bacterium Stenotrophomonas maltophilia. The DMO protein has not previously been assessed by FSANZ. It is anticipated that soybean plants containing event MON87708 may be grown in the United States of America and Canada subject to approval. There is no plan to grow the line in Australia or New Zealand.
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Date of authorization:	02/08/2012
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 (food safety):	In conducting a safety assessment of food derived from soybean line MON87708, a number of criteria have been addressed including: a characterisation of the transferred gene, its origin, function and stability in the soybean genome; the changes at the level of DNA, protein and in the whole food; compositional analyses; evaluation of intended and unintended changes; and the potential for the newly expressed protein to be either allergenic or toxic in humans. No potential public health and safety concerns have been identified in the assessment of soybean line MON87708. On the basis of the data provided in the present Application, and other available information, food derived from soybean line MON87708 is considered to be as safe for human consumption as food derived from conventional soybean cultivars.
Upload:	1_A1063 GM Soybean MON87708 AppR SD1 Safety Assess.pdf
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:	Application A1063 - Food derived from Herbicide-tolerant Soybean MON87708
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Authorization expiration date (a blank field means there is no expiration date)

E-mail:

[email protected]

Organization/agency name (Full name):

Ministry for Primary Industries

Contact person name:

john vandenbeuken

Website:

http://www.mpi.govt.nz

Physical full address:

Pastoral House, 25 The Terrace, Wellington, 6012

Phone number:

0298942581

Fax number:

Country introduction:

New Zealand and Australia share a joint food regulation system for the composition of labelling of most foods. Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of the joint food standards in Australia and New Zealand. The main office (approximately 120 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 15 staff) is located in Wellington on the North Island.

Useful links

Ministry for Primary Industries

Food Standards Australia New Zealand

Food Standards Australia New Zealand (FSANZ) submissions

Relevant documents

Stacked events:

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)

Paraguay
Name of product applicant:	MONSANTO
Summary of application:	MON 87708 soybean line was developed as a marker-free LMO to exhibit tolerance to dicamba (3,6-dichloro-2-methoxybenzoic acid) herbicide.
Upload:	33-2019-Resolucion MAG N 276-LC SOJA MON 87751 x MON 87701 x MON 87708 x MON 89788 (1).pdf
Date of authorization:	08/11/2019
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.):	MON-877Ø8-9
Summary of the safety assessment (food safety):	Simplified approval procedure: Through Ministry of Agriculture and Livestock Resolutions 1030 and 1071 there was stated a differentiated treatment for the commercial release of novel GE crops and for GE crops that have been approved in third countries, whose scientific, technical and safety characteristics are well-founded. Paraguayan Ministry of Agriculture’s Resolutions authorize taking into consideration the decision documents from third countries with regard to both human and animal food safety in the cases where these evaluations have been based on Codex Alimentarius, such as the Guidelines for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants and carried out in countries with time-tested regulatory systems and transparent procedures. Concerning environmental safety, assessments are accepted for GE crops that besides having been authorized for commercial planting in countries with sound regulatory systems, include in the decision documents considerations as follows: that the GE crop under review has been studied under different environmental conditions, behaving in the same way as the conventional non-GE counterpart; that it will be managed in an agronomic manner similar to any GE or conventional hybrid/variety of the species; another aspect is that Paraguay is not center of origin of that crop, and finally two relevant characteristics are that there are no related weeds in Paraguay with which the GE crop could cross-breed and that the main target pests and the main non-target arthropod species present in Paraguay have been taken into account in the GE risk assessment carried out in those countries. The Commercial Release Opinion of the National Commission for Agricultural and Forestry Biosafety (CONBIO), in its substantial part states: "...Recommends technically: (1) The commercial release of the event MON87708 (2) In case of detection of an unexpected effect, the company is obliged to inform CONBIO".
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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:	Paraguay’s Path Toward the Simplification of Procedures in the Approval of GE Crops
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Authorization expiration date (a blank field means there is no expiration date)

E-mail:

[email protected]

Organization/agency name (Full name):

Ministerio de Agricultura y Ganadería

Contact person name:

Santiago Bertoni

Website:

http://conbio.mag.gov.py

Physical full address:

Yegros 437 entre 25 de mayo y Cerro Cora

Phone number:

+595 981 256262

Fax number:

Country introduction:

The agricultural sector is one of the economic pillars of Paraguay in its contribution to the GDP, with the main crops being soybean, cassava, maize, wheat, sugar cane, and cotton. It should also be noted that Paraguay is the world’s fourth exporter of soybean. In 2020, the area planted with crops was 4.67 million hectares and consisted of soybean (3.56 million hectares), maize (1.08 million hectares), and cotton (18,000 hectares). Agricultural biotechnology was first regulated in Paraguay in 1997. In 2012, the system was adjusted through the creation of the National Agricultural and Forestry Biosafety Commission (CONBIO), “with the mission to manage, analyze, and issue recommendations on all matters related to the introduction, confined field trials, pre-commercial and commercial release, and other intended uses of GE crops” Almost 94% of the soybean, 36% of the maize, and 56% of the cotton planted in the country are GE.

Useful links

CONBIO

Paraguay’s Path Toward the Simplification of Procedures in the Approval of GE Crops

Relevant documents

Stacked events:

When a stacked event is approved, all possible combinations are approved. Previously evaluated single events are not reevaluated in stacks.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

In 2012, the system was adjusted through the creation of the National Agricultural and Forestry Biosafety Commission (CONBIO), “with the mission to manage, analyze, and issue recommendations on all matters related to the introduction, confined field trials, pre-commercial and commercial release, and other intended uses of GE crops”. Additional information https://conbio.mag.gov.py/

Philippines
Name of product applicant:	Monsanto Philippines
Summary of application:	Monsanto Philippines, Inc. has developed biotechnology-derived soybean MON87708 that is tolerant to dicamba herbicide. MON87708 was developed through Agrobacterium tumefaciens-mediated transformation of conventional conventional A3525 meristem tissue with the 2T-DNA plasmid vector PV-GMHT4355. PV-GMHT4355 contains two separate T –DNAs: first T-DNA contains the dmo expression cassette regulated by the peanut chlorotic streak caulimovirus promoter and the pea E9 3’ non translated region. The dmo gene, which was derived from Stenotrophomonas maltophilia (S. maltophilia); the second T-DNA (T-DNA II) contains the cp4 epsps expression cassette, functioned as a marker gene, under the regulation of the figwort mosaic virus (FMV) promoter and the pea E9 3’non-translated region. MON87708 contains a dmo expression cassette that produces a single MON87708 DMO precursor protein that is post- translationally processed into two forms of the dicamba mono-oxygenase (DMO) protein; referred to a MON87708 DMO protein and MON87708 DMO+27 protein. The active form of these proteins confer dicamba tolerance.
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Date of authorization:	05/05/2014
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):	Monsanto Philippines submitted an application to the Bureau of Plant Industry (BPI) requesting for Biosafety Permit under Administrative Order Number 8 (AO#8) Part 5 for Soybean MON87708 which has been genetically modified for herbicide tolerance. Monsanto Philippines has provided data on the identity of the soybean MON87708, a detailed description of the modification method, data and information on the gene insertion sites, copy numbers and levels of expression in the plant, the role of the inserted genes and regulatory sequences in donor organisms, and full nucleotide sequences. The novel proteins were identified, characterized, and compared to the original bacterial proteins, including an evaluation of their potential toxicity to livestock. Relevant scientific publications were also supplied. Soybean MON87708 has been evaluated according to BPI’s safety assessment by concerned agencies of the Department of Agriculture (DA) such as :{(Bureau of Animal Industry (BAI), Bureau of Agriculture, Fisheries and Product Standards (BAFPS)} and a Scientific Technical Review Panel (STRP). The process involves an intensive analysis of the nature of the genetic modification together with a consideration of general safety issues, toxicological issues and nutritional issues associated with the modified soybean. The petitioner/applicant published the Public Information Sheet (PIS) of the said application in two widely circulated newspapers for public comment/review. BPI received no comments on the petition during the 30-day comment period. Review of results of evaluation by the BPI Biotech Core Team completed the approval process.
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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):

Bureau of Plant Industry

Contact person name:

Geronima P. Eusebio

Website:

http://biotech.da.gov.ph/

Physical full address:

San Andres St., Malate, Manila

Phone number:

632 404 0409 loc 203

Fax number:

Country introduction:

In 1987, scientists from the University of the Philippines Los Banos (UPLB) and the International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI), and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD), recognizing the potential harm of the introduction of exotic species and genetic engineering, formed a committee and formulated the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. The committee went on to draft a Philippine biosafety policy, which was submitted to the Office of the President. On October 15, 1990, recognizing the potential for modern biotechnology both in improving the lives of the people and in creating hazards if not handled properly, President Corazon C. Aquino issued Executive Order 430 creating the National Committee on Biosafety of the Philippines (NCBP) that will formulate, review and amend national policy on biosafety and formulate guidelines on the conduct of activities on genetic engineering. The NCBP is comprised of representative of the Departments of Agriculture (DA); Environment and Natural Resources (DENR); Health (DOH); and Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science; and 2 respected members of the community. On July 16, 2001, President Gloria Macapagal-Arroyo issued the Policy Statement on Modern Biotechnology, reiterating the government policy on promoting the safe and responsible use of modern biotechnology. On April 3, 2002, Department of Agriculture Administrative Order No. 8, Series of 2002 was issued implementing the guidelines for importation and release into the environment of Plants and Plant Products Derived from the Use of Modern Biotechnology. On March 17, 2006, President Gloria Macapagal-Arroyo issued Executive Order No.514 Establishing the National Biosafety Framework, prescribing guidelines for its implementation, reorganizing the National Committee on Biosafety of the Philippines, and for other purposes. On December 8, 2015, the Philippine Supreme Court declared DA AO8 null and void and any application for contained use, field testing, propagation and commercialization, and importation of GMOs was temporarily enjoined. In response to the nullification of DA AO8, the Technical Working Group composed of representatives from the Departments of Agriculture (DA), Science and Technology (DOST), Environment and Natural Resources (DENR), Health (DOH), and Interior and Local Government (DILG) drafted the Joint Department Circular No. 1, Series of 2016 (JDC No.1, S2016) titled 'Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically-Modified Plant and Plant Products Derived from the Use of Modern Biotechnology'. There were series of meeting and five public consultations conducted before the JDC No.1, S2016 was approved and signed by the Secretaries of the abovementioned agencies on March 7, 2016 and took effect on April 15, 2016. Under this Circular, more government agencies were involved such as the Department of Science and Technology (DOST) to regulate applications for contained use and confined test of regulated articles; Department of Agriculture (DA) to evaluate applications for field trial, commercial propagation and transboundary movement of regulated articles; Department of Environment and Natural Resources (DENR) to evaluate environmental risks and impacts of regulated articles; Department of Health (DOH) to evaluate of environmental health impacts of regulated articles; and Department of the Interior and Local Government (DILG) to supervise public consultation during field trial.

Useful links

Biotechnology Philippines

BCH Pilipinas

Relevant documents

Stacked events:

Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.

Plant Products Carrying Stacked Genes Conferred Through (a) Genetic Engineering or b) Conventional Breeding, with Individual Traits That Have No Prior Approval:

A full risk assessnent as to food and feed or processing shall be conducted,consistent with Part V of AO No. 8,"Approval Process For the Importation of Regulated Articles for Direct Use as Food and Feed or For Processing for plant products with multiple traits conferred through:

(a) genetic engineering, or

(b) conventional breeding, where the individual traits have no prior approval from the Bureau of Plant Industry (BPI) for direct use as food and feed or processing.

Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:

For plant products with multiple traits conferred through conventional breeding,with all individual events granted prior approval and included in the Approval Registry, a notlfication shall be submitted by the technology developer to the BPI, which shall conduct an evaluation in accordance with the relevant criteria in Annex I of this Memorandum Circular. The list of data contained in Annex I will not preclude the inclusion of other issues and concerns that will be raised by the BPI and the Scientific and Technical Review Panel (STRP) during the course of the desktop review.

Notificatlon Requirement for Plant Products Carrying Stacked Genes

All technology developers shall submit a notification to the Bureau of Plant Industry of their developed plant products carrying stacked genes and shall be required to comply with the relevant approval process listed above.

The Bureau of Plant Industry shall issue a certiflcate as to the approval of the stacked gene product and shall likewise include the transformation event in the official approval registry of plant products for food and feed or processing.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004

Philippines
Name of product applicant:	Monsanto Philippines, Inc.
Summary of application:	On June 20, 2018 Monsanto Philippines Inc. filed for application of soybean MON87708 for direct use as food and feed, or for processing, as original application under the DOST-DA-DENR-DOH-DILG Joint Department Circular (JDC) No. 1 Series of 2016. After reviewing the Risk Assessment Report and attachments submitted by the Monsanto Philippines Inc., the assessors namely: Scientific and Technical Review Panel (STRP), BPI Plant Products Safety Services Division (BPI-PPSSD) and Bureau of Animal Industry-Biotech Team (BAI-BT), concurred that soybean MON87708 is as safe for human food and animal feed as its conventional counterpart.
Upload:	APP_FORM_MON87708.pdf
Date of authorization:	22/03/2022
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.):
Summary of the safety assessment (food safety):	Toxicological Assessment: The digestibility study indicated that DMO is rapidly degraded in simulated gastric fluid (SGF) within 30 seconds of incubation. The estimated T50 result for SGF is below 0.5 minutes [1][27]. Based on the bioassay data, DMO protein was deactivated after exposure to 55OC and above for 30 min [1][20]. Bioinformatics analyses using FASTA sequence alignment program and TOX-2010 database provided by the developer indicated that DMO has no significant homology to any known toxin [1][20]. Acute oral toxicity study indicated no treatment related adverse effects on survival, clinical observations, body weight gain, food consumption or gross pathology of mice administered with DMO protein [1][28]. Allergenicity Assessment: The results of bioinformatics analysis provided by the developer using FASTA sequence alignment tool and ALLERGENSEARCH program showed that DMO protein has no homology to any known toxins in the FARPP sequence AD_2010 database [1][32]. Based on the concentration of DMO protein in grain and percent dry weight of total protein in MON 87708, the percent of DMO protein in one gram of MON 87708 grain the DMO protein is 0.011% which represents a very small portion of total protein in MON 87708 harvested grain [1]. The results of assessment of the binding potential of human serum IgE antibodies and soybean-specific IgE binding to endogenous allergens provided showed comparable results with the IgE binding and conventional reference soybean varieties which do not pose any increased allergenicity concern [1][29]. Nutritional Data: Compositional analysis indicated significant differences between all proximate levels of MON 87708 and the non-transgenic soybean. It indicated significantly higher levels of ash, carbohydrates and fiber and significantly lower levels of protein in MON 87708 compared to non-transgenic soybean [1][7]. Results of the proximate analysis showed that the differences between the mean values obtained from MON 87708 and its conventional counterpart were not biologically relevant since all proximate levels of MON 87708 were still within the range of commercial reference varieties and literature values [7]. Compositional analysis indicated significant differences between all amino acid, fatty acid and vitamin E levels of MON 87708 and the non-transgenic soybean [7]. Combined-site analysis showed that majority of the parameters in MON 87708 were significantly lower than the non-transgenic soybean except for cystine, palmitic acid, linoleic acid, linolenic acid and vitamin E [1][7]. Statistical differences observed between MON 87708 and non-transgenic soybean were not biologically relevant since all key nutrient levels of MON 87708 were still within the range of commercial reference varieties and literature values [7]. Compositional analysis indicated significant differences between all antinutrient and isoflavone levels of MON 87708 and the non-transgenic soybean. Combined-site analysis showed that the levels of phytic acid, raffinose and stachyose in MON 87708 were significantly lower than the non-transgenic soybean while the level of daidzein was significantly higher [7]. Based on the compositional analysis, soybean MON 87708 is conventionally equivalent to that of conventional soybean. Hence, any effect of processing on the level of anti-nutrient in MON 87708 would be similar to that of the conventional soybean [33][34]. Statistical differences observed between MON 87708 and non-transgenic soybean were not biologically relevant since all antinutrient and isoflavone levels of MON 87708 were still within the range of commercial reference varieties and literature values. [7].
Upload:	CONSOL_SOYBEAN_MON_87708.pdf
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Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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E-mail:

[email protected]

Organization/agency name (Full name):

Bureau of Plant Industry

Contact person name:

Geronima P. Eusebio

Website:

http://biotech.da.gov.ph/

Physical full address:

San Andres St., Malate, Manila

Phone number:

632 404 0409 loc 203

Fax number:

Country introduction:

Useful links

Biotechnology Philippines

BCH Pilipinas

Relevant documents

Stacked events:

Plant Products Carrying Stacked Genes Conferred Through (a) Genetic Engineering or b) Conventional Breeding, with Individual Traits That Have No Prior Approval:

(a) genetic engineering, or

(b) conventional breeding, where the individual traits have no prior approval from the Bureau of Plant Industry (BPI) for direct use as food and feed or processing.

Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:

Notificatlon Requirement for Plant Products Carrying Stacked Genes

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004

Republic of Korea
Name of product applicant:	Monsanto Korea Ltd.
Summary of application:	Dicamba herbicide tolerance
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Date of authorization:	02/10/2013
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 link below(in Korean).
Upload:	MON87708_report.pdf
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Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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E-mail:

[email protected]

Organization/agency name (Full name):

Ministry of Food and Drug Safety

Contact person name:

Website:

Physical full address:

Osong Health Technology Administration Complex, 187, Osongsaengmyeong 2-ro, Osong-eup, Cheongwon-gun, Chungcheonbuk-do, 363-700, Korea

Phone number:

82-43-719-2360

Fax number:

Country introduction:

Useful links

Relevant documents

Stacked events:

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

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 soybean line MON87708 (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:	02/07/2019
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):	Peer review of the data submitted by the applicant and the results of complex medical and biological studies of transgenic soybean line MON87708 tolerant to the herbicide dicamba, attest to the absence of any toxic, reprotoxic, genotoxic, or allergenic effects of this soybean line. By biochemical composition, transgenic soybean line MON87708 was identical to conventional soybean. GM soybean line MON87708 has been registered for food use, listed in the State Register, and licensed for use in the territory of The Eurasian Economic Union, import into the territory of The Eurasian Economic Union, and placing on the market without restrictions.
Upload:	1_Regulation of GM food use in Russia_article_2016.pdf
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Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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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

Singapore
Name of product applicant:	Monsanto
Summary of application:	Apply for the purpose of food, feed and processing
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Date of authorization:	23/07/2019
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):	Soybean line MON87708 (MON-87708-9) is tolerant to the herbicide dicamba. This is achieved through expression of the enzyme dicamba mono-oxygenase (DMO) encoded by the dmo gene derived from Stenotrophomonas maltophilia. Soybean cultivar A3525 was transformed with two gene expression cassettes using an Agrobacterium-mediated method. The first cassette contained the dmo gene while the second cassette contained, as a marker, the commonly used cp4 epsps gene that confers tolerance to the herbicide glyphosate. Molecular analyses of soybean line MON87708 indicate there is a single insertion site comprising a complete copy of the dmo expression cassette. The second expression cassette containing the cp4epsps gene, that was used in the initial transformation, was deliberately segregated out and so is absent from MON87708. The introduced genetic elements are stably inherited from one generation to the next. Soybean line MON87708 expresses one new protein, DMO, which is non-toxic and non-allergenic to humans. Composition analyses showed the levels of key components in seed from soybean line MON87708 are similar to non-GM control or within the range of levels found in non-GM commercial soybean cultivars. Food derived from soybean line MON87708 is as safe as food derived from conventional soybean cultivars.
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Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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E-mail:

[email protected]

Organization/agency name (Full name):

Singapore Food Agency (SFA)

Contact person name:

Dr Tan Yong Quan

Website:

http://www.sfa.gov.sg

Physical full address:

52 Jurong Gateway Road 14-01 JEM Office Tower Singapore 608550

Phone number:

(65)68052750

Fax number:

Country introduction:

The Singapore Food Agency (SFA) is a Statutory Board established under the Ministry of Sustainability and the Environment (MSE) to oversee food safety and security. SFA’s mission is to ensure and secure a supply of safe food. SFA adopts a risk-based approach to food safety. Foods with foodborne hazards that may pose potential food safety risks to consumers are subjected to more stringent checks, regardless of their country of origin. SFA has in place an integrated system to ensure that both imported and domestically produced foods are safe for consumption. The system comprises control measures such as source accreditation, inspection and surveillance of food, laboratory analysis, food legislation and recall of food products, which safeguard food safety from farm to fork.

Useful links

https://www.sfa.gov.sg/food-import-export/commercial-food-imports

Relevant documents

Stacked events:

More information on the guidelines for the safety assessment of stacked events can be found on GMAC’s website:

http://www.gmac.sg/Index_Singapore_Guidelines_on_the_Release_of_Agriculture_Related_GMOs.html

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Singapore Food Agency (SFA)

Thailand
Name of product applicant:	Bayer Thai Co., Ltd.
Summary of application:	Commodity: Soybean (Glycine max L.) Soybean event MON87708 has been genetically modified to expresses enzymedicamba mono-oxygenase (DMO) which confers tolerance to dicamba-based herbicide.
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Date of authorization:	04/12/2022
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):	The food safety assessment performed by the National Center for Genetic Engineering and Biotechnology (BIOTEC) as advisory and technical arm of Thai FDA. BIOTEC conduct food safety assessment according to codex guideline and based on the safety data and information provided by the applicant (as specified in Annex 2 attached to Notification of the Ministry of Public Health No.431). According to the existing scientific data and information available during the safety assessment, it is concluded that the soybean event MON 87708 is substantially equivalent to its conventional counterpart in terms of morphology, nutrition, toxicity and allergenicity.
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E-mail:

[email protected]

Organization/agency name (Full name):

National Burequ of Agricultural Commodity and Food

Contact person name:

Director of Office of Standard Development

Website:

http://www.acfs.go.th

Physical full address:

50 Phahonyothin Rd., Lardyao, Chathuchak, Bangkok 10900

Phone number:

+6625612277 ext.1401

Fax number:

+6625613373

Country introduction:

National Bureau of Agricultural Commodity and Food Standards (ACFS) is a governmental agency under the Ministry of Agriculture and Cooperatives (MOAC) responsible for the development of national agricultural and food standards. The Agricultural Standards Act B.E. 2551 (2008) establishes the mechanisms for the development of Thai Agricultural Standards (TAS) as either voluntary or mandatory standards. This is based on scientific data, consumer’s health and fair trade. Within the TAS, there are four standards relating GM food assessment, namely Principle for the Risk Analysis of Foods Derived from Biotechnology (TAS 9010-2006), Assessment of Possible Allergenicity (TAS 9011-2006), Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (TAS 9012-2006) and Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms (TAS 9013-2006). These standards are adapted from relevant Codex standards. Safety assessment for imported GM crops and foods is done by the cooperation of the Food and Drug Administration (FDA) and the National Center for Genetic Engineering and Biotechnology (BIOTEC)via the Committees relating National Committees to consider technical and political issues. The Committees comprise representatives from all relevant governmental and non-governmental key sectors including experts on genetic modification, toxicity and others.

The safety assessment process of GM food in Thailand is on a voluntary basis. According to the current laws and regulations, there is no approval authority.

Useful links

Thai Agricultural Standards relevant to GM foods

Relevant documents

TAS-9011-2006.pdf

TAS-9012-2006.pdf

TAS_9013-2006.pdf

Stacked events:

The safety assessment for stacked events is divided into two patterns. The first pattern is for stacked events whose GM parents have never approved by FDA or other competent authority. Those stacked events shall be fully assessed in line with GM foods. Another pattern is introduced for the safety assessment of stacked event lines where from GM parents had already been approved. In the second pattern, the information of the parents could be used for consideration, as appropriate. However, the information relevant to interaction between genes and new proteins of stacked event should be mainly taken into account.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Food and Drug Administration (FDA) and National Center for Genetic Engineering and Biotechnology (BIOTEC)

Türkiye
Name of product applicant:	Special case: please show below
Summary of application:	Application for direct use as feed Turkish Biosafety Law, entered in force in 2010, diverges from EU legislations in some points such as food and feed use require different separate applications, risk assessments and approvals. Addition, our Law forsees prision sentences in some circumtances of Law violation and joint reponsibilities for the violation. Therefore, GM product owners avoid to make application for approval and non product developer have made application till now. Instead, some Turkish assosiations such as poultry producers assosiations, animal feed assosiations have applied to get approval for import of GM products for their members. Thus, name of product applicant is not product developers for our country. Turkish Poultry Meat Producers and Breeders Association
Upload:	Report of scientific committee- Soybean-MON 87708.pdf
Date of authorization:	02/08/2017
Scope of authorization:	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):	After the evaluation of reports released by Scientific Risk Assessment Committee and Socio- economic Assessment Committee Biosafety Board has approved the use of genetically modified soybean MON87708 and products thereof for animal feed.
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E-mail:

[email protected]

Organization/agency name (Full name):

DG of Agricultural Research and Policies (TAGEM)

Contact person name:

Ramazan BULBUL

Website:

http://www.tagem.gov.tr

Physical full address:

Universiteler Mah. Dumlupınar Bulvarı, Eskişehir Yolu 10. Km Çankaya/ANKARA/TURKEY

Phone number:

+90 312 307 60 48

Fax number:

+90 312 307 61 90

Country introduction:

Turkey is party to the Cartagena Protocol on Biosafety (CPB) since Jan 24, 2004. Biosafety applications in Turkey are carried out within the framework of the Biosafety Law (no.5977) which entered into force in 26 September 2010 and its relevant regulations (“The Regulation on Genetically Modified Organisms and Products” and “The Regulation Connected with Working Procedure and Principles of Biosafety Board and Committees”). Biosafety Law and two regulations came into force on 26th September 2010.

Main objectives of the Biosafety Law are;

to prevent risks that may arise from GMO’s and products which are produced by using of modern biotechnology by taking into account scientific and technological developments;
to establish and implement biosafety system to ensure protection and sustainability of environment, biological diversity and health of human, animal and plant;
to inspect, regulate and monitor the activities in the scope of the law.

The Law includes specific points regarding research, development, processing, releasing on the market, monitoring, using, import, export, handling, transportation, packaging, labelling, storage and similar operations in relation to GMO and GMOPs.

Veterinarian medicinal products and medicinal products for human use and also cosmetic products which are permitted or certified by the Ministry of Health are out of this Law’s scope.

According to Biosafety Law following actions connected with GMO and GMOPs are prohibited:

Releasing GMO and GMOPs on the market without approval of Ministry of Agriculture and Forestry.
Production of genetically modified plants and animals.
Using GMO and GMOPs in baby food and baby formulae, follow-on baby food and follow-on formulae, infant and kid’s nutritional supplements

According to the Biosafety Law, which was enacted in 2010, the Biosafety Board, which was established within the scope of the Law, was responsible for evaluating the applications regarding GMO and its products.

However, the duties and powers of the Biosafety Board were assigned to the Ministry of Agriculture and Forestry with the Presidential Circular No. 2018/3 published in the Official Gazette on the date of August 2, 2018.

The task of evaluating the applications related to GMO and its products, performing the secretarial services of the Committees and other duties specified in the Biosafety Law and related regulations has been assigned to General Directorate of Agricultural Research and Policies (TAGEM) under the Ministry of Agriculture and Forestry pursuant to Ministerial Approval dated 05/12/2018.

Ministry of Agriculture and Forestry makes a “Decision” about applications on GMO and products via taking Scientific Committees’ risk assessment and socio-economic assessment into account.

For each application the Ministry of Agriculture and Forestry assigns a new committee and each committee makes different assessment for each application. It is important to note that in Turkey food and feed each have a different assessment application.

Members of scientific committees are selected from the List of Experts.

11 members are selected for each GMO application.

List of Experts has been made up by the evaluation of Ministry of Agriculture and Forestry from the applicants who applied via using the Biosafety Clearing-House Mechanism of Turkey. Applicants were faculty members and experts of Universities and TÜBİTAK (The Scientific and Technological Research Council of Turkey).

To date, 13 types of GM soybean and 23 types of GM maize were approved as feed for import.

Besides, by the use of aspergillus oryzae, developed through modern biotechnological methods, licences for industrial α-amylase, glucoamylase and hemicellulase enzyme production were granted.

Threshold of labeling of GMO products that are approved by Ministry of Agriculture and Forestry is 0.9%.

There are not any applications for using GMO and products as food.

After placing GMO and GMOPs on the market; the Ministry controls and inspects whether or not conditions designated by decision are met.

Activities of analysis are performed in laboratories designated by the Ministry.

In the case of any non-compliance detected with relation to the GMO Legislation (such as a failure to specify the contained GMO on the label, identification of an unapproved gene, etc.) legal action is taken.

Application evaluation process is like below:

Evaluation of application by Ministry of Agriculture and Forestry 90 days
Feedback to the applicant 15 days
Ministry of Agriculture and Forestry’s “Decision” 270 days

(Starts from feedback to the applicant)

Establishing of Scientific Committees

Report preparation of Committees

Report’s public release

Evaluation of public opinions by Committees

Ministry of Agriculture and Forestry’s final decision after taking reports and public opinions into

account

Publishing the Positive Decision 30 days
Reclamation period to Negative Decision 60 days
Evaluation of reclamation by Ministry of Agriculture and Forestry 60 days

Useful links

http://www.tbbdm.gov.tr

Relevant documents

Stacked events:

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Ministry of Agriculture and Forestry

General Directorate of Agricultural Research and Policies

Focal Point of the FAO GM Foods Platform

Ramazan BULBUL

Email: [email protected]

United States of America
Name of product applicant:	Monsanto Company
Summary of application:	Soybean Trait 1 Added Protein: dmo gene expressing a dicamba mono-oxygenase (DMO) precursor protein that is post-translationally processed into two isoforms Source: Stenotrophomonas maltophilia strain DI-6 Intended Effect: Tolerance to the herbicide dicamba
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Date of authorization:	11/10/2011
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):	Please consult the FDA website links below.
Upload:
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Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:	FDA's webpage regarding this variety
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E-mail:

[email protected]

Organization/agency name (Full name):

Food and Drug Administration

Contact person name:

Jason Dietz

Website:

http://www.fda.gov

Physical full address:

5100 Paint Branch Parkway, College Park MD 20740

Phone number:

240-402-2282

Fax number:

Country introduction:

The United States is currently in the process of populating this database. The Food and Drug Administration regulates food and feed (food for humans and animals) from genetically engineered crops in conjunction with the Environmental Protection Agency (EPA). EPA regulates pesticides, including those that are plant incorporated protectants genetically engineered into food crops, to make sure that pesticide residues are safe for human and animal consumption and do not pose unreasonable risks of harm to human health or the environment. FDA In the Federal Register of May 29, 1992 (57 FR 22984), FDA published its "Statement of Policy: Foods Derived from New Plant Varieties" (the 1992 policy). The 1992 policy clarified the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act with respect to human and animal foods derived from new plant varieties and provided guidance to industry on scientific and regulatory issues related to these foods. The 1992 policy applied to all foods derived from all new plant varieties, including varieties that are developed using genetic engineering (also known as recombinant deoxyribonucleic acid (rDNA) technology). In the 1992 policy, FDA recommended that developers consult with FDA about foods from genetically engineered plants under development and developers have routinely done so. In June 1996, FDA provided additional guidance to industry on procedures for these consultations (the consultation procedures). These procedures describe a process in which a developer who intends to commercialize food from a genetically engineered plant meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the genetically engineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food. FDA evaluates the submission and if FDA has questions about the summary provided, it requests clarification from the developer. At the conclusion of the consultation FDA responds to the developer by letter. The approach to the safety assessment of genetically engineered food recommended by FDA during consultations, including data and information evaluated, is consistent with that described in the Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants. EPA The safe use of pesticidal substances is regulated by EPA. Food from a genetically engineered plant that is the subject of a consultation with FDA may contain an introduced pesticidal substance, also known as a plant-incorporated protectant (PIP), that is subject to food (food for humans and animals) safety and environmental review by EPA. PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. Both the PIP protein and its genetic material are regulated by EPA. When assessing the potential risks of PIPs, EPA requires studies examining numerous factors, such as risks to human health, non-target organisms and the environment, potential for gene flow, and insect resistance management plans, if needed. In regulating PIPs, decisions are based on scientific standards and input from academia, industry, other Federal agencies, and the public. Before the first PIP product was registered in 1995, EPA required that PIP products be thoroughly tested against human safety standards before they were used on human food and livestock feed crops. EPA scientists assessed a wide variety of potential effects associated with the use of PIPs, including toxicity, and allergenicity. These potential effects were evaluated in light of the public's potential exposures to these pesticides, taking into account all potential combined sources of the exposure (food, drinking water, etc.) to determine the likelihood that a person exposed at these levels would be predisposed to a health risk. Based on its reviews of the scientific studies and often peer reviews by the Federal Insecticide, Fungicide and Rodenticide Scientific Advisory Panel, EPA determined that these genetically engineered PIP products, when used in accordance with approved label directions and use restrictions, would not pose unreasonable risk to human health and the environment during their time-limited registration.

Useful links

Genetically Engineered Plants for Food & Feed

Completed Consultations on Bioengineered Plant Foods

Relevant documents

Stacked events:

Stacked events that are each plant incorporated protectants, as defined by the Environmental Protection Agency, must be registered by the Envriornmental Protection Agency before they can be commercialized. Food/feed safety asssessment of single events are generally sufficient to ensure the safety of food/feed from stacked events.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Food and Drug Administration ([email protected]); Environmental Protection Agency

Vietnam
Name of product applicant:	MON-877Ø8-9
Summary of application:	The herbicide tolerant soybean MON 87708 contains a dmo gene derived from the bacterium Stenotrophomonas maltophilia that produces a single MON 87708 DMO precursor protein that is post-translationally processed into two forms of the dicamba mono oxygenase (DMO) protein necessary to confer dicamba tolerance. MON 87708 was developed through Agrobacterium-mediated transformation of conventional soybean meristem tissue with the 2T DNA plasmid vector PV GMHT4355.
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Date of authorization:	20/04/2015
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):	The data and information in the safety assessment demonstrate that the food and feed derived from MON 87708 are as safe and nutritious as conventional soybean, a familiar crop with a long history of safe consumption. The food and feed safety of MON 87708 was confirmed through multiple, well established lines of evidence: 1. The safety of the donor organism, S. maltophilia, based on its ubiquitous presence in the environment, presence in healthy individuals, and the incidental presence in foods without any adverse safety reports. 2. A detailed molecular characterization of the inserted DNA demonstrated a single, intact copy of the T DNA stably inserted in a single locus within the soybean genome. 3. A history of safe use has been established for MON 87708 DMO. Data confirmed that MON 87708 DMO is unlikely to be a toxin or allergen based on extensive information collected. MON 87708 DMO was readily digestible in simulated gastric fluid,and showed no oral toxicity or cause any adverse effect in mice. 4. A compositional assessment of seed and forage confirmed that MON 87708 is compositionally equivalent to conventional soybean.
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Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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E-mail:

[email protected]

Organization/agency name (Full name):

Ministry of Agriculture and Rural development

Contact person name:

Nguyen Thi Thanh Thuy

Website:

http://www.mard.gov.vn

Physical full address:

2, Ngoc Ha, Ba Dinh, Ha Noi, Viet Nam

Phone number:

+84 08044643

Fax number:

+83 4 38433637

Country introduction:

The process for authorizing a GM food, feed is based on the Vietnam regulation on GM food and feed (Circular No. 02/2014/TT-BNNPTNT). An application for authorizing food, feed derived or made from a GM plant must be submitted to national authorities (Ministry of Agriculture and Rural Development-MARD). The national authority proceeds prior review the dossier/application and makes the application summary report available to the public. The authority then sends the application to the Food, Feed Safety Committee (FFSC) members for reviewing and risk assessment. FFSC is inter-ministerial committee established by the Minister of Agriculture and Rural Development in order to consult to MARD’s minister for issuance, revocation the Food, feed safety Certificate. Once FFSC performing the risk assessment (desktop reviewing), the public has 30 days to comment on MARD website for application. Within 180 days of receiving the appropriate application, FFSC complete the assessment and submit the final report to the national authority/MARD under Circular 02/2014/TT-BNNPTNT. Within 30 days receiving FFSC comment and conclusion, the national authority grants or refuses to issuing certificate.

Safety regulations have derived based upon the internationally established scientific guidelines and principles of Codex Alimentarius Commission, FAO, WHO and OECD.

FFSC does not separately assess food, feed from stacked event lines where food, feed from the GM parental events has already been approved separately; Mandate notification of stacked events by developers.

Useful links

Relevant documents

Stacked events:

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: