02019D1308 — EN — 16.02.2021 — 001.001

This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

►B COMMISSION IMPLEMENTING DECISION (EU) 2019/1308 of 26 July 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 87411 (MON-87411-9), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2019) 5487) (Only the Dutch and French texts are authentic) (Text with EEA relevance) (OJ L 204 2.8.2019, p. 85)

Amended by:









▼B

COMMISSION IMPLEMENTING DECISION (EU) 2019/1308

of 26 July 2019

authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 87411 (MON-87411-9), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document C(2019) 5487)

(Only the Dutch and French texts are authentic)

(Text with EEA relevance)







Article 1

Genetically modified organism and unique identifier

Genetically modified maize (Zea mays L.) MON 87411, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-87411-9, as provided for in Regulation (EC) No 65/2004.

Article 2

Authorisation

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 MON-87411-9 maize;

(b) feed containing, consisting of or produced from MON-87411-9 maize;

(c) products containing or consisting of MON-87411-9 maize for uses other than those provided for in points (a) and (b) of this Article, with the exception of cultivation.

Article 3

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 documents accompanying products containing or consisting of MON-87411-9 maize, with the exception of products referred to in point (a) of Article 2.

Article 4

Method for detection

The method set out in point (d) of the Annex shall apply for the detection of MON-87411-9 maize.

Article 5

Monitoring for environmental effects

1. The authorisation holder 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 holder 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 Decision 2009/770/EC.

Article 6

Community register

The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as referred to in Article 28(1) of Regulation (EC) No 1829/2003.

▼M1

Article 7

Authorisation holder

The authorisation holder shall be Bayer CropScience LP, United States, represented in the Union by Bayer Agriculture BV, Belgium.

▼B

Article 8

Validity

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

▼M1

Article 9

Addressee

This Decision is addressed to Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.

▼B









ANNEX

▼M1

(a) Applicant and authorisation holder:

Name: Bayer CropScience LP

Address: 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States

Represented by Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium

▼B

(b) Designation and specification of the products:

(1) foods and food ingredients containing, consisting of or produced from MON-87411-9 maize;

(2) feed containing, consisting of or produced from MON-87411-9 maize;

(3) products containing or consisting of MON-87411-9 maize for uses other than those provided in points (1) and (2), with the exception of cultivation.

The genetically modified MON-87411-9 maize expresses the CP4 EPSPS protein, which confers tolerance to glyphosate-containing herbicides, the Cry3Bb1 protein and the DvSnf7 dsRNA, which confer resistance to corn rootworm (Diabrotica spp.).

(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 documents accompanying the products containing or consisting of MON-87411-9 maize, with the exception of products referred to in point (b)(1) of this Annex.

(d) Method for detection:

(1) Event-specific real-time quantitative PCR based method for detection of the genetically modified maize MON 87411.

(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: AOCS 0215-B is accessible via the American Oil Chemists' Society (AOCS) at https://www.aocs.org/crm

(e) Unique identifier:

MON-87411-9

(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 Community 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 Community 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 Community register of genetically modified food and feed.