02017D1207 — EN — 24.09.2019 — 001.001

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►B COMMISSION IMPLEMENTING DECISION (EU) 2017/1207 of 4 July 2017 renewing the authorisation for the placing on the market of genetically modified maize MON 810 (MON-ØØ81Ø-6) products pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2017) 4453) (Only the Dutch and French texts are authentic) (Text with EEA relevance) (OJ L 173 6.7.2017, p. 18)

Amended by:









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COMMISSION IMPLEMENTING DECISION (EU) 2017/1207

of 4 July 2017

renewing the authorisation for the placing on the market of genetically modified maize MON 810 (MON-ØØ81Ø-6) products pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document C(2017) 4453)

(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 810, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-ØØ81Ø-6, in accordance with Regulation (EC) No 65/2004.

Article 2

Renewal of the authorisation

The authorisation of the following products is renewed in accordance with the conditions set out in this Decision:

(a) foods and food ingredients produced from MON-ØØ81Ø-6 maize, with the exception of pollen;

(b) feed containing, consisting of or produced from MON-ØØ81Ø-6 maize;

(c) MON-ØØ81Ø-6 maize in products containing it or consisting of it for any other use than food or feed, with the exception of cultivation.

Article 3

Labelling

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 of the European Parliament and of the Council ( 1 ), the ‘name of the organism’ shall be ‘maize’.

Article 4

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 to this Decision, 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 the format set out in Decision 2009/770/EC.

Article 5

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 referred to in Article 28 of Regulation (EC) No 1829/2003.

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Article 6

Authorisation holder

The authorisation holder shall be Bayer Agriculture BVBA, Belgium, representing Monsanto Company, United States of America.

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Article 7

Validity

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

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Article 8

Addressee

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

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ANNEX

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(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.

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(b) Designation and specification of the products:

(1) foods and food ingredients produced from MON-ØØ81Ø-6 maize, with the exception of pollen;

(2) feed containing, consisting of, or produced from MON-ØØ81Ø-6 maize;

(3) MON-ØØ81Ø-6 maize in products containing it or consisting of it for any other use than food or feed, with the exception of cultivation.

The genetically modified MON-ØØ81Ø-6 maize as described in the applications expresses the Cry1Ab protein, derived from Bacillus thuringiensis subsp. kurstaki, which confers protection against predation by certain lepidopteran insect pests, including the European corn borer (Ostrinia nubilalis) and pink borers (Sesamia spp.).

(c) Labelling:

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’;

(d) Method for detection:

(1) Event-specific real-time PCR-based method for the quantification of MON-ØØ81Ø-6 maize;

(2) Validated by the Federal Institute for Risk assessment (BfR) in collaboration with the Joint Research Centre of the European Commission and other parties, and verified by the EU Reference Laboratory established under Regulation (EC) No 1829/2003 on genomic DNA extracted from maize seeds, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx

(3) Reference Material: ERM-BF413 and ERM-AD413 accessible via the Institute for Reference Materials and Measurements (IRMM) of the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/

(e) Unique identifier:

MON-ØØ81Ø- 6

(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.