Decision 2013/650

Contents

Article 1Genetically modified organism and unique identifiers#

As provided for in Regulation (EC) No 65/2004, the following unique identifiers are assigned:

(a)for genetically modified maize (Zea mays L.) MON89034 × 1507 × MON 88017 × 59122:unique identifier MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7;

(b)for genetically modified maize (Zea mays L.) MON89034 × 1507 × MON 88017:unique identifier MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3;

(c)for genetically modified maize (Zea mays L.) MON 89034 × 1507 × 59122:unique identifier MON-89Ø34-3 × DAS-Ø15Ø7-1 × DAS-59122-7;

(d)for genetically modified maize (Zea mays L.) MON 89034 × MON88017 × 59122:unique identifier MON-89Ø34-3 × MON-88Ø17-3 × DAS-59122-7;

(e)for genetically modified maize (Zea mays L.) 1507 × MON 88017 × 59122:unique identifier DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7;

(f)for genetically modified maize (Zea mays L.) MON 89034 × 1507:unique identifier MON-89Ø34-3 × DAS-Ø15Ø7-1;

(g)for genetically modified maize (Zea mays L.) MON 89034 × 59122:unique identifier MON-89Ø34-3 × DAS-59122-7;

(h)for genetically modified maize (Zea mays L.) MON 1507 × MON 88017:unique identifier DAS-Ø15Ø7-1 × MON-88Ø17-3;

(i)for genetically modified maize (Zea mays L.) MON 88017 × 59122:unique identifier MON-88Ø17-3 × DAS-59122-7.

These genetically modified maizes (Zea mays L.) are specified in point (b) of the Annex to this Decision.

Article 2Authorisation#

The following products are authorised for the purposes of Article 4(2) and Article 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:

(a)foods and food ingredients containing, consisting of, or produced from the GMOs specified by their unique identifiers in Article 1;

(b)feed containing, consisting of, or produced from the GMOs specified by their unique identifiers in Article 1;

(c)the GMOs specified by their unique identifiers in Article 1 in products containing them or consisting of them for any other use than (a) and (b), with the exception of cultivation.

Article 3Labelling#

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 documents accompanying products containing or consisting of the GMOs specified by their unique identifiers in Article 1 with the exception of products referred to in point (a) of Article 2.

Article 4Monitoring for environmental effects#

1.The authorisation holders shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.

2.The authorisation holders shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with the Decision 2009/770/EC.

Article 5Community register#

The information set out in the Annex to this Decision shall be entered in the EU register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Article 6Authorisation holders#

1.The authorisation holders shall be:

(a)Corteva Agriscience LLC, United States of America, represented by Corteva Agriscience Belgium B.V.; and

(b)Bayer CropScience LP, United States of America, represented by Bayer Agriculture BV, Belgium.

2.Both authorisation holders shall be responsible for fulfilling the duties imposed on authorisation holders by this Decision and Regulation (EC) No 1829/2003.

Article 7Validity#

This Decision shall apply for a period of 10 years from the date of its notification.

Article 8Addressees#

This Decision is addressed to:

(a)Corteva Agriscience LLC, 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States of America, represented by Corteva Agriscience Belgium B.V., Bedrijvenlaan 9, 2800 Mechelen, Belgium; and

(b)Bayer CropScience LP, 800 N. Lindbergh Boulevard, St Louis, Missouri, 63167, United States of America, represented by Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.

(a) Applicants and Authorisation holders

Name: | Corteva Agriscience LLCAddress: | 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States of America

represented by Corteva Agriscience Belgium B.V., Bedrijvenlaan 9, 2800 Mechelen, Belgium

and

Name:	Bayer CropScience LP
Address:	800 N. Lindbergh Boulevard, St Louis, Missouri, 63167, United States of America

represented by Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.

(b) Designation and specification of the products

(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

(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

—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

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.

Article 1Genetically modified organism and unique identifiers#

Article 2Authorisation#

Article 3Labelling#

Article 4Monitoring for environmental effects#

Article 5Community register#

Article 6Authorisation holders#

Article 7Validity#

Article 8Addressees#

(a) Applicants and Authorisation holders

(b) Designation and specification of the products

(c) Labelling

(d) Methods for detection

(e) Unique identifiers

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

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

(h) Monitoring plan

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

History · 1 version

Connections

Article 1Genetically modified organism and unique identifiers#

Article 2Authorisation#

Article 3Labelling#

Article 4Monitoring for environmental effects#

Article 5Community register#

Article 6Authorisation holders#

Article 7Validity#

Article 8Addressees#

(a) Applicants and Authorisation holders

(b) Designation and specification of the products

(c) Labelling

(d) Methods for detection

(e) Unique identifiers

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

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

(h) Monitoring plan

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

Key facts