Food safety and quality
| share
 

OECD Unique Identifier details

DAS-Ø15Ø7-1 x MON-ØØ81Ø-6 x SYN-IR162-4 x MON-ØØ6Ø3-6
Commodity: Corn / Maize
Traits: Herbicide tolerance,Insect resistance
Argentina
Name of product applicant: Pioneer Argentina S.R.L.
Summary of application:

Pioneer has used classical breeding techniques to obtain corn with the accumulated event DAS-Ø15Ø7-1 x MON-ØØ81Ø-6 x SYN-IR162-4 x MON-ØØ6Ø3-6 (TC1507 x MON810 x MIR162 x NK603), combining the characters expressed by the individual events conferring protection against lepidopteran insects and tolerance to herbicides.
The proteins Cry1F, Cry1Ab and Vip3A20 expressed by these accumulated events, confer protection against the attack of plague insects, such as Diatraea sacharallis, while the expression of the PAT and CP4 EPSPS proteins provide tolerance to herbicides based on glufosinate-ammonium and glyphosate.

Upload:
Date of authorization: 29/01/2016
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.):
Summary of the safety assessment (food safety):
• Inheritance studies conducted indicated that Mendelian segregation exists. • New expression proteins are expressed in low levels. • It is compositionally equivalent to its non-transgenic counterpart. • No evidence of similarity or homology was found with known toxic proteins. • There is no evidence of expression of known allergenic substances for the proteins expressed in the event. It is concluded that the event is substantially equivalent to its conventional counterpart, therefore, it is as safe and no less nutritious than conventional commercial varieties.
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: GMO commercial approvals in Argentina
GMO approvals for food/feed
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministerio de Agroindustria
Contact person name:
Andrés Maggi
Website:
Physical full address:
Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number:
54 11 5222 5986
Fax number:
Country introduction:

In Argentina, the food and feed risk assessment process of transformation events, as the result of modern biotechnology, is carried out by the National Service for Agrifood Health and Quality (Senasa). The General Office of Biotechnology, is the area responsible for carrying out this task. It has an specific professional team and the advise of a Technical Advisory Committee composed of experts from several scientific disciplines representing different sectors involved in the production, industrialization, consumption, research and development of genetically modified organisms.

Useful links
Relevant documents
Stacked events:

Stacked events with all single events approved, are assessed as a new event, but with much less requirements, always on a case-by-case basis.

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

National Service for Agrifood Health and Quality (Senasa)

https://www.argentina.gob.ar/senasa

 

https://www.argentina.gob.ar/senasa/programas-sanitarios/biotecnologia

Brazil
Name of product applicant: Du Pont do Brasil
Summary of application:

Commercial release of maize TC15Ø7 x MON81Ø x MIR162 x NK6Ø3

Upload:
Date of authorization: 09/04/2015
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.): ISAAA
Summary of the safety assessment (food safety):
Du Pont do Brasil S. A - Pioneer Seeds Division, requested CTNBio's opinion on the biosafety of hybrid corn selected by conventional crossing resulting from the combination of TC15Ø7 x MON81Ø x MIR162 x MON6Ø3 events, for the purpose of their release into the environment, Marketing, consumption and any other activities related to that GMO and its progenies. Event TC15Ø7 x MON81Ø x MIR162 x MON6Ø3 and its subcombinations are produced by conventional crosses between individual genetically modified events that have already been evaluated for risk by CTNBio. TC1507 maize contains the cry1F gene and the pat gene. The insecticidal protein present in TC1507 maize is a truncated Cry1F protein derived from strain PS81I from Bacillus thuringiensis var. Aizawai. The pat gene, from Streptomice viridrochromogenes, confers tolerance to the herbicide glufosinate ammonium. The MON810 maize line contains the B. thuringiensis cry1Ab gene. The MIR162 event, which contains the Vip3Aa protein is a Bacillus thurigiensis protein, but unlike the crystal proteins (Cry) of Bacillus thuringiensis, Vip proteins (Vegetative Insecticidal Proteins) are produced during bacterial growth. The NK603 event contains the cp4 epsps gene encoding a glyphosate-tolerant form of the enzyme 5-enolpyruvlyshikimate-3-phosphate synthase (EPSPS) was isolated from the bacterium Agrobacterium tumefaciens CP4 strain. The applicant also requested authorization for the subcombinations: DAS-Ø15Ø7-1 (TC1507) x SYN-IR162-4 (MIR162) x MON-ØØ603-6 (NK603); DAS-Ø15Ø7-1 (TC1507) x SYN-IR162-4 (MIR162); SYN-IR162-4 (MIR162) x MON-ØØ603-6 (NK603) and MON-Ø810-6 (MON810) x SYN-IR162-4 (MIR162). The analysis of the risk assessment of the combined event TC1507 x MON810 x MIR162 x NK603 occurred on a case-by-case basis and considered, according to Art. 3 of RN 5/2008, the information previously presented for the individual events that contain the same genetic construct and The information of the present commercial release proposal, aiming to verify if the data presented by the applicant corroborate the hypothesis that there is no interaction between the inserts present in the combined event. In the proposed commercial release of the event TC1507 x MON810 x MIR162 x NK603 the information presented included the molecular characterization of the event; Evaluation of protein expression; The composition analysis of different plant tissues, insect studies and the results of experiments for agronomic and phenotypic evaluations of the combined event. CTNBio evaluated combined event data for molecular characterization (PCR and Southern Blot), grain and forage composition, expression of heterologous proteins, control of target insects and herbicide tolerance, and no evidence of interactions was found between the four events that indicated The need for additional risk analyzes to those already carried out for individualized events, both in human and animal health as well as in the environment. According to article 2 of RN no. 15/2015, which amends Art. 22 of RN no. 5/2008, the company submitted a request for commercial release of the subcombinations of this event: DAS-Ø15Ø7-1 (TC1507) x SYN-IR162 -4 (MIR162) x MON-Ø603-6 (NK603); DAS-Ø15Ø7-1 (TC1507) x SYN-IR162-4 (MIR162); SYN-IR162-4 (MIR162) x MON-Ø603-6 (NK603); MON-Ø810-6 (MON810) x SYN-IR162-4 (MIR162) and were also deferred by CTNBio. CTNBio reviewed the reports submitted by the applicant as well as independent scientific literature. Scientific studies carried out to evaluate biosafety, agronomic and phenotypic characteristics, as part of the risk assessment of this GMO, included representative regions for corn cultivation in Brazilian territory. CTNBio concluded that the event TC15Ø7 x MON81Ø x MIR162 x MON6Ø3 and said subcombinations keep with the biota the same ratio as conventional maize. The restrictions on the use of the GMO under analysis and its derivatives are conditioned to the provisions of Law 11,460 of March 21, 2007.
Upload:
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: National Biosafety Commission
Upload:
Authorization expiration date (a blank field means there is no expiration date) Not Applicable
E-mail:
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Maria Sueli Felipe Soares
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556134115516
Fax number:
556133177475
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
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. Edivaldo Domingues Velini (President of national Biosafety Commission)

Colombia
Name of product applicant: Dupont Colombia S.A
Summary of application:

Authorization of the genetically modified maize TC1507 X MON810 X MIR162 X NK603 resistant to lepidoptera pest attack and tolerant to herbicides glyphosate and glufosinate

Upload:
Date of authorization: 25/08/2015
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.
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:
Organization/agency name (Full name):
Ministerio de salud y proteccion social
Contact person name:
Daniel Rubio
Website:
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: Dupont de Colombia S.A
Summary of application:

GMO authorization for TC1507 X MON810 X MIR162 X NK603 maize as food for direct use or processing.

Upload:
Date of authorization: 25/08/2020
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.
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:
Organization/agency name (Full name):
Ministerio de salud y proteccion social
Contact person name:
Daniel Rubio
Website:
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:
Japan
Name of product applicant: DuPont K.K.
Summary of application:

A stacked maize TC1507 x MON810 x MIR162 x NK603 has been obtained through conventional breeding of each of the parental organisms. The modifications in these lines confer tolerance to the glyphosate and glufosinate herbicides and resistance to Lepidoptera and European Corn Borer pests.

Upload:
Date of authorization: 28/01/2013
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.): BCH Database
Summary of the safety assessment (food safety):
Please see the link 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)
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,
Contact person name:
Mariko Murakami
Website:
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
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)

Philippines
Name of product applicant: Pioneer Hi-Bred
Summary of application:

Pioneer Hi-Bred Philippines, Inc. has filed an application with attached technical dossiers to the Bureau of Plant Industry on June 13, 2014 for a biosafety notification for direct use as food and feed or for processing under Administrative Order (AO) No. 8, Part 5 for combined trait product maize TC1507 x MON810 x MIR162 x NK603, which was developed by conventionally crossing four genetically modified maize events (TC1507, MON810, MIR162 and NK603) for insect (lepidopteran) protection and herbicide resistance.


A safety assessment of combined trait product maize TC1507 x MON810 x MIR162 x NK603was conducted as per Department of Agriculture Administrative Order No. 8 Series of 2002 and Memorandum Circular No. 8, Series of 2004.  The risk assessment focused on the gene interaction, effect on metabolic pathways and differential gene expression between/among the transgenes.


The Public Information Sheet (PIS) of the said application was published in Malaya Business Insight and The Daily Tribune on September 3, 2014 for public comments/review. BPI received no comment on the petition during the 15-days comment period.


Review of results of evaluation by the BPI Biotech Core Team completed the approval process.

Upload:
Date of authorization: 28/10/2014
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):
The inserted genes, cry1F, pat, cry1Ab, vip3Aa20, pmi and cp4 epsps genes, and their gene products have history of safe use and have been assessed by many countries and local regulators for food and feed safety. Cry1F, PAT, Cry1Ab, Vip3Aa20, PMI and CP4 EPSPS proteins expressed in TC1507 x MON810 x MIR162 x NK603 maize do not present the characteristics associated with allergenic proteins. No interactions among the gene products or negative synergistic effects are expected in the stack hybrid product. The lack of potential interaction between the transgenes in TC1507 x MON810 x MIR162 x NK603 maize and the evidence that the stacked product is as safe as its conventional counterpart further affirms the safety of the lower-order stack combinations. Based on nutrient composition results from forage samples analyzed for proximates, fiber and minerals; and grains samples analyzed for proximates, fiber, fatty acids, amino acids, minerals, vitamins, secondary metabolites and anti-nutrients, TC1507 x MON810 x MIR162 x NK603 maize was found to be comparable to forage and grain derived from non-genetically modified (non-GM) near-isoline control maize and non-GM commercial reference maize. The World Health Organization (1995) stated that when two plants that are substantially equivalent to conventional varieties are crossed by conventional breeding techniques, the combined trait product is expected to be substantially equivalent to the single event products.
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:
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Geronima P. Eusebio
Website:
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
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

Republic of Korea
Name of product applicant: DuPont (Korea) Inc.
Summary of application:

Glufosinate herbicide tolerance , Glyphosate herbicide tolerance  , Lepidopteran insect resistance          

Upload:
Date of authorization: 10/04/2013
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.):
Summary of the safety assessment (food safety):
Please see the link below(in Korean).
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:
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: