Commission Implementing Decision (EU) 2018/1111
of 3 August 2018
authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87427 × MON 89034 × NK603 (MON-87427-7 × MON-89Ø34-3 × MON-ØØ6Ø3-6) and genetically modified maize combining two of the events MON 87427, MON 89034 and NK603, and repealing Decision 2010/420/EU
(notified under document C(2018) 5014)
(Only the Dutch and French texts are authentic)
(Text with EEA relevance) (revoked)

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Decision revoked: (E.) (20.5.2022) by The Genetically Modified Food and Feed (Authorisations) (England) Regulations 2022 (S.I. 2022/486), regs. 1(b), 4(e); (W.) (20.5.2022) by The Genetically Modified Food and Feed (Authorisations) (Wales) Regulations 2022 (S.I. 2022/472), regs. 1(2)(c), 4(e); and (S.) (31.5.2022) by The Genetically Modified Food and Feed (Authorisations) (Scotland) Regulations 2022 (S.S.I. 2022/137), regs. 1(1), 4(e)

Article 1 Genetically modified organism and unique identifier
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Article 2 Authorisation
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Article 3 Labelling
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Article 4 Monitoring for environmental effects
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Article 5 Method for detection
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Article 6 Register
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Article 7 Authorisation holder
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Article 8 Repeal
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Article 9 Validity
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Article 10 Addressee
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ANNEX (a) Applicant and authorisation holder:

Name
Bayer Agriculture BVBA

Address
Scheldelaan 460, 2040 Antwerp, Belgium
On behalf of:
Monsanto Company — 800 N. Lindbergh Boulevard — St. Louis, Missouri 63167 — United States of America.
(b) Designation and specification of the products:
(1) foods and food ingredients containing, consisting of, or produced from genetically modified maize (Zea mays L.) referred to in point (e);
(2) feed containing, consisting of, or produced from genetically modified maize (Zea mays L.) referred to in point (e);
(3) genetically modified maize (Zea mays L.) referred to in point (e) in products containing them or consisting of them for uses other than those provided for in points (1) and (2), with the exception of cultivation.
MON-87427-7 maize expresses CP4 EPSPS protein, which confers tolerance to glyphosate-based herbicides.
MON-89Ø34-3 maize expresses the Cry1A.105 and Cry2Ab2 proteins, which confer protection against certain lepidopteran pests.
MON-ØØ6Ø3-6 maize expresses CP4 EPSPS protein and the variant CP4 EPSPS L214P, which confer tolerance to glyphosate-based herbicides.
(c) Labelling:
(1) For the purposes of the labelling requirements laid down in Article 13(1) and Article 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 the accompanying documents of the products containing or consisting of the maize specified in (e), with the exception of foods and food ingredients.
(d) Method for detection:
(1) The quantitative event-specific PCR detection methods for maize MON-87427-7 × MON-89Ø34-3 × MON-ØØ6Ø3-6 are those validated for genetically modified maize events MON-87427-7, MON-89Ø34-3 and MON-ØØ6Ø3-6.
(2) Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
(3) Reference Material: ERM®-BF415 (for MON-ØØ6Ø3-6) is accessible via the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/ as well as AOCS 0512-A (for MON-87427-7), AOCS 0906-E (for MON-89Ø34-3) are accessible via the American Oil Chemists Society at https://www.aocs.org/crm
(e) Unique identifiers:
MON-87427-7 × MON-89Ø34-3 × MON-ØØ6Ø3-6;
MON-87427-7 × MON-ØØ6Ø3-6;
MON-89Ø34-3 × MON-ØØ6Ø3-6;
MON-87427-7 × MON-89Ø34-3.
(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:
[Biosafety Clearing-House, Record ID number: published in the ... register of genetically modified food and feed when notified].
(g) Conditions or restrictions on the placing on the market, use or handling of the products:
Not required.
(h) Monitoring plan for environmental effects:
Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
[Link: plan published in the ... register of genetically modified food and feed]
(i) Post-market monitoring requirements for the use of the food for human consumption
Not required.
Note: links to relevant documents may need to be modified over the time. Those modifications will be made available to the public via the updating of the ... register of genetically modified food and feed.