Commission Implementing Decision of 6 November 2013 authorising the placing on the market of products containing, consisting of, or produced from genetically modified (GM) maize MON 89034 × 1507 × MON88017 × 59122 (MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7), four related GM maizes combining three different single GM events (MON89034 × 1507 × MON88017 (MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3), MON89034 × 1507 × 59122 (MON-89Ø34-3 × DAS-Ø15Ø7-1 × DAS-59122-7), MON89034 × MON88017 × 59122 (MON-89Ø34-3 × MON-88Ø17-3 × DAS-59122-7), 1507 × MON 88017 × 59122 (DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7)) and four related GM maizes combining two different single GM events (MON89034 × 1507 (MON-89Ø34-3 × DAS-Ø15Ø7-1), MON89034 × 59122 (MON-89Ø34-3 × DAS-59122-7), 1507 × MON88017 (DAS-Ø15Ø7-1 × MON-88Ø17-3), MON 88017 × 59122 (MON-88Ø17-3 × DAS-59122-7)) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2013) 4755) (Only the Dutch, English and French texts are authentic) (Text with EEA relevance) (2013/650/EU) (c. 650)

F1 ANNEX U.K.

Textual Amendments

F1 Word in Annex omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 205; 2020 c. 1, Sch. 5 para. 1(1)

(a) [F2 Authorisation holders U.K.

(1)

Corteva Agriscience LLC, 9330 Zionsville Road, Indianapolis, Indiana 46268-1054, United States of America, represented in Great Britain by Corteva Agriscience UK Limited, Cpc2 Capital Park, Fulbourn, Cambridge, CB21 5XE, United Kingdom, and

(2)

Bayer CropScience LP, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States of America, represented in Great Britain by Bayer CropScience Limited, 230 Cambridge Science Park, Milton Road, Cambridge, CB4 0WB, United Kingdom.]

Textual Amendments

F2 Words in Annex point (a) substituted (26.4.2023) by The Genetically Modified Food and Feed (Authorisations and Modifications of Authorisations) (Wales) Regulations 2023 (S.I. 2023/379), regs. 1(2)(c), 7(4); The Genetically Modified Food and Feed (Authorisations and Modifications of Authorisations) (England) Regulations 2023 (S.I. 2023/235), regs. 1(b), 7(4); by virtue of The Genetically Modified Food and Feed (Authorisations and Modifications of Authorisations) (Scotland) Regulations 2023 (S.S.I. 2023/59), regs. 1(1), 7(4)

(b) Designation and specification of the products U.K.

(1)

foods and food ingredients containing, consisting of, or produced from genetically modified maizes (Zea mays L.) as specified in (e);

(2)

feed containing, consisting of, or produced from genetically modified maizes (Zea mays L.) as specified in (e);

(3)

the genetically modified maizes (Zea mays L.) as specified in (e) in products containing it or consisting of it for any other uses than (1) and (2), with the exception of cultivation.

MON-89Ø34-3 maize expresses the Cry1A.105 and Cry2Ab2 proteins which confer protection against certain lepidopteran pests.

DAS-Ø15Ø7-1 maize, expresses the Cry1F protein which confers protection against certain lepidopteran pests and the PAT protein, which confers tolerance to the herbicide glufosinate-ammonium.

MON-88Ø17-3 maize expresses a modified Cry3Bb1 protein which provides protection to certain coleopteran pests and the CP4 EPSPS protein which confers tolerance to the herbicide glyphosate.

DAS-59122-7 maize expresses Cry34Ab1 and Cry35Ab1 proteins which confer protection against certain coleopteran pests and the PAT protein, which confers tolerance to the herbicide glufonisate-ammonium.

(c) Labelling U.K.

(1)

For the purposes of the specific 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 documents accompanying products containing or consisting of the maizes specified in (e) with the exception of products referred to in point (a) of Article 2.

(d) Methods for detection U.K.

• Event specific real-time PCR based methods for quantitative detection of genetically modified maize MON-89Ø34-3, DAS-Ø15Ø7-1, MON-88Ø17-3 and DAS-59122-7 maize; the detection methods validated on the single-trait events and verified on MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7 would function with a comparable efficacy for the individual GMOs as specified in (e);

• DNA extraction method validated on ground maize seeds by the European Union Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx

• Reference Material: ERM®-BF424 (for DAS-59122-7) and ERM®-BF418 (for DAS-Ø15Ø7-1) accessible via the Joint Research Centre (JRC) of the European Commission, Institute for Reference Materials and Measurements (IRMM) at https://irmm.jrc.ec.europa.eu/rmcatalogue and AOCS 0906-E and AOCS 0406-A (for MON-89Ø34-3) and AOCS 0406-D and AOCS 0406-A (for MON-88Ø17-3) accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm

(e) Unique identifiers U.K.

• MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7;

• MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3;

• MON-89Ø34-3 × DAS-Ø15Ø7-1 × DAS-59122-7;

• MON-89Ø34-3 × MON-88Ø17-3 × DAS-59122-7;

• DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7;

• MON-89Ø34-3 × DAS-Ø15Ø7-1;

• MON-89Ø34-3 × DAS-59122-7;

• DAS-Ø15Ø7-1 × MON-88Ø17-3;

• MON-88Ø17-3 × DAS-59122-7.

(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity U.K.

Biosafety Clearing-House, Record ID: see [to be completed when notified].

(g) Conditions or restrictions on the placing on the market, use or handling of the products U.K.

Not required.

(h) Monitoring plan U.K.

Monitoring plan for environmental effects conforming with Annex VII of Directive 2001/18/EC.

[Link: plan published on the internet]

(i) Post market monitoring requirements for the use of the food for human consumption U.K.

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 F1 ... register of genetically modified food and feed. U.K.