Food safety and quality
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OECD Unique Identifier details

DAS-59122-7xDAS-Ø15Ø7xMON-ØØ6Ø3-6
Commodity: Corn / Maize
Traits: Glyphosate tolerance,Lepidoptera resistance,Coleoptera resistance,Glufosinate tolerance
European Union
Name of product applicant: Pioneer
Summary of application:

The genetically modified maize DAS-59122-7xDAS-Ø15Ø7xMON-ØØ6Ø3-6, as described in the application, expresses the Cry34Ab1 and Cry35Ab1 proteins which confer protection against certain coleopteran pests, the Cry1F protein which confers protection against certain lepidopteran pests, the PAT protein which confers tolerance to the glufosinate-ammonium herbicides and the CP4 EPSPS protein which confers tolerance to glyphosate herbicides.


 

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Date of authorization: 03/08/2018
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 quantitative PCR based method for genetically modified maize DAS-59122-7xDAS-Ø15Ø7xMON-ØØ6Ø3-6. Reference material: ERM®-BF418 (for DAS-Ø15Ø7-1), ERM®-BF424 (for DAS-59122-7) and ERM®-BF415 (for MON-ØØ6Ø3-6) are accessible via the Joint Research Centre (JRC) of the European Commission. Please see the EU relevant links below.
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Method for detection
Reference Material
Opinion of the European Food Safety Authority
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Authorization expiration date (a blank field means there is no expiration date) 05/08/2028
E-mail:
Organization/agency name (Full name):
European Union
Contact person name:
Alexandre Huchelmann
Website:
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).

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