ANNEX U.K.

(a) Applicant and Authorisation holder: U.K.

Name

:

[F1 Syngenta Crop Protection NV/SA]

Address

:

[F1 Avenue Louise 489, 1050 Brussels, Belgium]

Textual Amendments

F1 Substituted by Commission Implementing Decision (EU) 2019/60 of 11 January 2019 amending Decision 2009/866/EC, Decision 2010/419/EU, Implementing Decision 2012/651/EU and Implementing Decision (EU) 2016/1685 as regards the representative of the authorisation holder (notified under document C(2019) 15) (Only the Dutch and French texts are authentic) (Text with EEA relevance).

On behalf of Syngenta Crop Protection AG — Schwarzwaldallee 215 — CH 4058 Basle — Switzerland.

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

(1)

Foods and food ingredients containing, consisting of, or produced from SYN-IR6Ø4-5 maize;

(2)

Feed containing, consisting of, or produced from SYN-IR6Ø4-5 maize;

(3)

Products other than food and feed containing or consisting of SYN-IR6Ø4-5 maize for the same uses as any other maize with the exception of cultivation.

The genetically modified SYN-IR6Ø4-5 maize, as described in the application, expresses a modified Cry3A protein which provides protection to certain coleopteran pests (Diabrotica spp.). A pmi gene, allowing transformed maize cells to utilise mannose as a sole carbon source, was used as a selectable marker in the genetic modification process.

(c) Labelling: U.K.

(1)

For the purposes of the specific 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’;

(2)

The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of SYN-IR6Ø4-5 maize referred to in Article 2(b) and (c) of this Decision.

(d) Method for detection: U.K.

• Event specific real-time PCR based method for the quantification of SYN-IR6Ø4-5 maize,

• Validated on seeds by the Community Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm,

• Reference Material: ERM®-BF423 accessible via the Joint Research Centre (JRC) of the European Commission, the Institute of Reference Materials and Measurements (IRMM) at http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm

(e) Unique identifier: U.K.

SYN-IR6Ø4-5.

(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 to 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 Community register of genetically modified food and feed. U.K.