Commission Implementing Decision (EU) 2018/1112 of 3 August 2018 renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2018) 5020) (Text with EEA relevance.)

• CELEX: Implementing Decision (EU) 2018/1112
• Articles: 10

Article 1 Genetically modified organism and unique identifier

Genetically modified maize ( Zea mays L.) GA21, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-ØØØ21-9, in accordance with Regulation (EC) No 65/2004.

Article 2 Renewal of the authorisation

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

(a)

food and food ingredients containing, consisting of or produced from maize GA21;

(b)

feed containing, consisting of or produced from maize GA21;

(c)

maize GA21 in products containing it or consisting of it for any other use than those provided for in points (a) and (b), 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 the products containing or consisting of maize GA21, with the exception of food and food ingredients.

Article 4 Method for detection

The method set out in point (d) of the Annex shall apply for the detection of maize GA21.

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

Article 7 Authorisation holder

The authorisation holder shall be Syngenta Crop Protection AG, Switzerland, represented by Syngenta Crop Protection NV/SA, Belgium.

Article 8 Validity

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

Article 9 Addressee

This Decision is addressed to Syngenta Crop Protection NV/SA, Avenue Louise 489, 1050 Brussels, Belgium.

Schedules & Appendices

ANNEX

ANNEX

(a)    Applicant and authorisation holder:

Name

:

Syngenta Crop Protection AG

Address

:

Schwarzwaldallee 215, CH-4058 Basel, Switzerland

Represented by Syngenta Crop Protection NV/SA, Avenue Louise 489, 1050 Brussels, Belgium.

(b)    Designation and specification of the products:

(1)

food containing, consisting of, or produced from maize GA21;

(2)

feed containing, consisting of, or produced from maize GA21;

(3)

maize GA21 in products containing it or consisting of it for any other use than those provided for in points (1) and (2), with the exception of cultivation.

Maize GA21, as described in the application, expresses the mEPSPS protein which confers tolerance to glyphosate herbicide.

(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 maize GA21, with the exception of food and food ingredients.

(d)    Method for detection:

(1)

Event-specific real-time quantitative PCR-based method for detection of the genetically modified maize MON-ØØØ21-9.

(2)

Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/summaries/GA21Syngenta_validated_Method_correctedVersion1.pdf

(3)

Reference Material: AOCS 0407-A and AOCS 0407-B are accessible via the American Oil Chemists Society (AOCS) at https://www.aocs.org/crm

(e)    Unique identifier:

MON-ØØØ21-9

(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 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 of the European Parliament and of the Council  ( 1 ) .

[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.

( 1 )   Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC ( OJ L 106, 17.4.2001, p. 1 ).