Commission Decision of 3 March 2006 authorising the placing on the market of food containing, consisting of, or produced from genetically modified maize line 1507 (DAS-Ø15Ø7-1) and renewing the authorisation to place on the market feed produced from such maize, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (2006/197/EC)

ANNEX U.K.

(a) Applicants and authorisation holders

:

Name

:

Pioneer Overseas Corporation

Address

:

Avenue des Arts 44, B-1040 Brussels.

On behalf of Pioneer Hi-Bred International, Inc., 400 Locus Street, Suite 800, Des Moines, IA50309, United States of America

and

Name

:

Dow AgroSciences Europe Ltd

Address

:

European Development Centre, 3 Milton Park, Abingdon, Oxon OX14 4RN, United Kingdom.

On behalf of Mycogen Seeds c/o Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054, United States of America.

[F1 (b) Designation and specification of the products

:

(i)

foods and food ingredients containing, consisting of, or produced from DAS-Ø15Ø7-1 maize;

(ii)

feed produced from DAS-Ø15Ø7-1 maize.

The genetically modified DAS-Ø15Ø7-1 maize, as described in the application, is resistant to the European corn borer ( Ostrinia nubilalis ) and certain other lepidopteran pests and is tolerant to the herbicide glufosinate-ammonium. The genetically modified DAS-Ø15Ø7-1 maize contains the following DNA sequences in two cassettes:

— cassette 1

:

A synthetic version of the truncated cry 1F gene from Bacillus thuringiensis subsp. aizawai , which confers resistance to the European corn borer ( Ostrinia nubilalis ) and certain other lepidopteran pests, under the regulation of the ubiquitin promoter ubi ZM1(2) from Zea mays L. and the ORF25PolyA terminator from Agrobacterium tumefaciens pTi15955,

— cassette 2

:

A synthetic version of the pat gene from Streptomyces viridochromogenes strain Tü494, which confers tolerance to the herbicide glufosinate-ammonium, under the regulation of the 35S promoter and terminator sequences from Cauliflower Mosaic Virus .]

[F1 (c) Labelling

:

• No specific requirements other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003.

• For the purpose of Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, the ‘name of organism’ shall be ‘maize’.]

Textual Amendments

F1 Substituted by Commission Decision of 17 June 2011 amending Decision 2006/197/EC as regards the renewal of the authorisation to place on the market existing feed produced from genetically modified maize line 1507 (DAS-Ø15Ø7-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2011) 4159) (Only the Dutch, English and French texts are authentic) (Text with EEA relevance) (2011/365/EU).

(d) Method for detection

:

• Event specific real-time quantitative PCR based method for genetically modified maize DAS-Ø15Ø7-1.

• Validated by the Community reference laboratory established pursuant to Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.it/detectionmethods/TC1507-WEB-Protocol-Validation.pdf

• Reference Material: ERM®-BF418 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

:

DAS-Ø15Ø7-1

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

:

Biosafety Clearing House, Record ID: see Decision 2006/197/EC.

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

:

Not required.

(h) Monitoring plan

:

Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC

(Link: http://gmo-crl.jrc.it/detectionmethods/TC1507-WEB-Protocol-Validation.pdf)

(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 time. Those modifications will be made available to the public via the updating of the F2 ... Register of genetically modified food and feed. U.K.

Textual Amendments

F2 Word in Annex omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 61; 2020 c. 1, Sch. 5 para. 1(1)