ffc_auth-maizebt11mir162mir604ga21anditssub-combinationsbt11mir162mir604bt11mir162ga21bt11mir604ga21mir162mir604ga21bt11mir162bt11mir604bt11ga21mir162mir604mir162ga21mir604ga21.uniqueidentifiersofthesub-combinationsarelistedintheindividualpage.

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ffc_auth-maizebt11mir162mir604ga21anditssub-combinationsbt11mir162mir604bt11mir162ga21bt11mir604ga21mir162mir604ga21bt11mir162bt11mir604bt11ga21mir162mir604mir162ga21mir604ga21.uniqueidentifiersofthesub-combinationsarelistedintheindividualpage. figure au registre OGM en alimentation humaine et animale de l’Union européenne.

⚠️ « Autorisé » n’est pas « sans danger » : c’est un registre réglementaire, pas un avis sanitaire.

Ce que le registre en dit

Domain code	ffc
Authorisation type code	ffc_auth
Gmff product name	Maize Bt11 × MIR162 × MIR604 × GA21 and its sub-combinations: Bt11 × MIR162 × MIR604; Bt11 × MIR162 × GA21; Bt11 × MIR604 × GA21; MIR162 × MIR604 × GA21; Bt11 × MIR162; Bt11 × MIR604; Bt11 × GA21; MIR162 × MIR604; MIR162 × GA21; MIR604 × GA21.
Gmff unique identifier	SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-ØØØ21-9; SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5; SYN-BTØ11-1 × SYN-IR162-4 × MON-ØØØ21-9; SYN-BTØ11-1 × SYN-IR6Ø4-5 × MON-ØØØ21-9; SYN-IR162-4 × SYN-IR6Ø4-5 × MON-ØØØ21-9; SYN-BTØ11-1 × SYN-IR162-4; SYN-BTØ11-1 × SYN-IR6Ø4-5; SYN-BTØ11-1 × MON-ØØØ21-9; SYN-IR162-4 × SYN-IR6Ø4-5; SYN-IR162-4 × MON-ØØØ21-9; SYN-IR6Ø4-5 × MON-ØØØ21-9.
Gmff category	1974789
Gmff company	1974859
Gmff product details show if	gmffProducts,gmffDesignation,gmffLabelling,gmffMethodForDetection,gmffReferenceMaterial,gmffAnnexIICartagenaProtocol,gmffCondOrRestrOnPlacingOnMarket,gmffPostMarketMonitoringReq,gmffFurtherInfoOnRiskAssessment,gmffEvent,gmffMonitoringPlan
Gmff products	(1) Foods and food ingredients containing, consisting of, or produced from the GMOs, as referred to in the "Unique identifiers" row; (2) Feed containing, consisting of, or produced from the GMOs, as referred to in the "Unique identifiers" row; (3) Products, other than food and feed, containing or consisting of the GMOs, as referred to in the "Unique identifiers" row, for the same uses as any other maize with the exception of cultivation.
Gmff designation	The genetically modified maize SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-ØØØ21-9 maize, as described in the application, is produced by crosses between maize containing SYN-BTØ11-1, SYN-IR162-4, SYN-IR6Ø4-5 and MON-ØØØ21-9 events and expresses the Cry1Ab and Vip3Aa20 proteins which confer protection against certain lepidopteran pests; Cry3A protein which confers protection against certain coleopteran pests; mEPSPS protein which confers tolerance to the glyphosate herbicide and PMI protein which was used as a selectable marker.
Gmff labelling	(1) For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the 'name of the organism' shall be 'maize'. (2) The words 'not for cultivation' shall appear on the label of and in documents accompanying products containing or consisting of from the GMOs, as referred to in the "Unique identifiers" row and referred to point (2) and (3) in the “Products” row.
Gmff method for detection	Event specific real-time quantitative PCR based methods for SYN-BTØ11-1, SYN-IR162-4, SYN-IR6Ø4-5 and MON-ØØØ21-9 maizes; the detection methods are validated on the single-trait events and verified on genomic DNA extracted from seeds of SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-ØØØ21-9 maize. Validated by the European Union Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx .
Gmff reference material	ERM®-BF412 (for SYN-BTØ11-1), ERM®-BF446 (for SYN-IR162-4) and ERM®-BF423 (for SYN-IR6Ø4-5) accessible via the Joint Research Centre (JRC) of the European Commission, at https://crm.jrc.ec.europa.eu/ and AOCS 0407-A and AOCS 0407-B (for MON-ØØØ21-9) accessible via the American Oil Chemists Society at https://www.aocs.org/crm?SSO=True .
Gmff annex i i cartagena protocol	https://bch.cbd.int/database/record.shtml?documentid=110991
Gmff cond or restr on placing on market	Specific conditions for the placing on the market as mentioned in the Commission Implementing Decision (EU) 2016/1685 of 16 September 2016 .
Gmff monitoring plan	Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC
Gmff post market monitoring req	Not required.
Gmff further info on risk assessment	Opinion of the European Food Safety Authority: https://doi.org/10.2903/j.efsa.2015.4297 https://doi.org/10.2903/j.efsa.2017.4745
Gmff event	Bt11 × MIR162 × MIR604 × GA21, and its sub-combinations: Bt11 × MIR162 × MIR604; Bt11 × MIR162 × GA21; Bt11 × MIR604 × GA21; MIR162 × MIR604 × GA21; Bt11 × MIR162; Bt11 × MIR604; Bt11 × GA21; MIR162 × MIR604; MIR162 × GA21; MIR604 × GA21.
Legislation existing ref	1973892
Gmff legislation type	1974783
Legislation existing ref	1974243
Gmff authorisation date	2016-09-19T10:00:00.000+00:00
Gmff expiry date	2026-09-18T10:00:00.000+00:00
Gmff renew req subm on time	yes
Product status	Renewal process ongoing

Source : Commission européenne, portail FIP, registre « OGM en alimentation humaine et animale », capture du 2026-09-03.