ANNEX U.K.

[F1 (a) Applicant and authorisation holder U.K.

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.]

Textual Amendments

F1 Substituted by Commission Implementing Decision (EU) 2019/1579 of 18 September 2019 amending Decisions 2008/933/EC, 2009/813/EC, 2009/814/EC and 2010/429/EU and Implementing Decisions 2012/82/EU, 2012/83/EU, 2012/347/EU, 2013/649/EU, (EU) 2015/683, (EU) 2015/684, (EU) 2015/685, (EU) 2015/686, (EU) 2015/687, (EU) 2015/688, (EU) 2015/689, (EU) 2015/693, (EU) 2015/695, (EU) 2015/696, (EU) 2015/700, (EU) 2015/701, (EU) 2015/2279, (EU) 2015/2281, (EU) 2016/1216, (EU) 2016/1217, (EU) 2017/1207, (EU) 2018/1111, (EU) 2018/2045 and (EU) 2018/2046 as regards the representative of the authorisation holder for placing on the market certain genetically modified food and feed in the Union (notified under document C(2019) 6520) (Only the Dutch text is authentic) (Text with EEA relevance).

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

1.

foods and food ingredients containing, consisting of, or produced from MON-ØØØ73-7 oilseed rape, with the exception of isolated seed protein;

2.

feed produced from MON-ØØØ73-7 oilseed rape.

The genetically modified MON-ØØØ73-7 oilseed rape, as described in the applications, expresses the CP4 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS) and glyphosate oxidoreductase variant 247 (GOXv247) proteins which confer tolerance to glyphosate-based herbicides.

(c) Labelling U.K.

For the purposes of the specific 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 ‘oilseed rape’.

(d) Method for detection U.K.

• Event-specific real-time PCR based method for the quantification of MON-ØØØ73-7 oilseed rape.

• Validated on genomic DNA, extracted from seeds by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx

• Reference Material: AOCS 0304-A and AOCS 0304-B are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm

(e) Unique identifier U.K.

MON-ØØØ73-7

(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity U.K.

Biosafety Clearing-House (to be entered in the F2 ... register of genetically modified food and feed when notified).

Textual Amendments

F2 Word in Annex point (f) 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, 287(a); 2020 c. 1, Sch. 5 para. 1(1)

(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 (to be entered in the F3 ... register of genetically modified food and feed when notified).

Textual Amendments

F3 Word in Annex point (h) 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, 287(b); 2020 c. 1, Sch. 5 para. 1(1)

(i) Post-market monitoring requirements for the use of the food for human consumption U.K.

Not required.