Commission Implementing Decision of 10 February 2012 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87701 (MON-877Ø1-2) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2012) 701) (Only the Dutch and French texts are authentic) (Text with EEA relevance) (2012/83/EU) (c. 83)

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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-877Ø1-2 soybean.

(2)

Feed containing, consisting of, or produced from MON-877Ø1-2 soybean.

(3)

Products other than food and feed containing or consisting of MON-877Ø1-2 soybean for the same uses as any other soybean with the exception of cultivation.

The genetically modified MON-877Ø1-2 soybean, as described in the application, expresses the Cry1Ac protein which confers protection against certain lepidopteran pests.

(c) Labelling U.K.

(1)

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 ‘soybean’.

(2)

The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of MON-877Ø1-2 soybean 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 MON-877Ø1-2 soybean,

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

• reference material: AOCS 0809-A and AOCS 0906-A accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm

(e) Unique identifier U.K.

MON-877Ø1-2

(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 EU register of genetically modified food and feed. U.K.