02018D1113 — EN — 08.07.2019 — 001.001

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►B COMMISSION IMPLEMENTING DECISION (EU) 2018/1113 of 3 August 2018 renewing the authorisation for the placing on the market of food and feed produced from genetically modified sugar beet H7-1 (KM-ØØØH71-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2018) 5029) (Only the Dutch, French and German texts are authentic) (Text with EEA relevance) (OJ L 203 10.8.2018, p. 32)

Amended by:









▼B

COMMISSION IMPLEMENTING DECISION (EU) 2018/1113

of 3 August 2018

renewing the authorisation for the placing on the market of food and feed produced from genetically modified sugar beet H7-1 (KM-ØØØH71-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document C(2018) 5029)

(Only the Dutch, French and German texts are authentic)

(Text with EEA relevance)







Article 1

Genetically modified organism and unique identifier

Genetically modified sugar beet (Beta vulgaris subsp. vulgaris) H7-1, as specified in point (b) of the Annex, is assigned the unique identifier KM-ØØØH71-4, in accordance with Regulation (EC) No 65/2004.

Article 2

Renewal of 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) foods and food ingredients produced from KM-ØØØH71-4 sugar beet;

(b) feed produced from KM-ØØØH71-4 sugar beet.

Article 3

Labelling

For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, the ‘name of the organism’ shall be ‘sugar beet’.

Article 4

Method for detection

The method set out in point (d) of the Annex shall apply for the detection of sugar beet H7-1.

Article 5

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 6

Authorisation holders

1. The authorisation holders shall be:

(a) KWS SAAT SE, Germany; and

(b) ►M1 Monsanto Company, United States of America, represented by Bayer Agriculture BVBA, Belgium ◄ .

2. Both authorisation holders shall be responsible for fulfilling the duties imposed on authorisation holders by this Decision and Regulation (EC) No 1829/2003.

Article 7

Validity

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

Article 8

Addressee

This Decision is addressed to:

(a) KWS SAAT SE, Grimsehlstrasse 31, 37574 Einbeck, Germany; and

(b) ►M1 Bayer Agriculture BVBA, Scheldelaan 460, 2040 Antwerp, Belgium ◄ .









ANNEX

▼M1

(a) Applicants and Authorisation holders:

Name: KWS SAAT SE Address: Grimsehlstrasse 31, 37574 Einbeck, Germany and

Name: Monsanto Company Address: 800 N, Lindbergh Boulevard, St. Louis, Missouri 63167, United States of America

Represented by Bayer Agriculture BVBA, Scheldelaan 460, 2040 Antwerp, Belgium.

▼B

(b) Designation and specification of the products:

(1) Foods and food ingredients produced from KM-ØØØH71-4 sugar beet;

(2) Feed produced from KM-ØØØH71-4 sugar beet.

The genetically modified KM-ØØØH71-4 sugar beet, as described in the application, expresses the CP4 EPSPS protein after insertion of the cp4 epsps gene from Agrobacterium sp. strain CP4 into sugar beet (Beta vulgaris subsp. vulgaris).

The CP4 EPSPS protein confers tolerance to glyphosate containing herbicides.

(c) Labelling:

For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, the ‘name of the organism’ shall be ‘sugar beet’.

(d) Method for detection:

(1) Event specific realtime PCR-based method for the quantification of KM-ØØØH71-4 sugar beet.

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

(3) Reference Material: ERM®-BF419 is accessible via the Joint Research Centre (JRC) of the European Commission, at https://ec.europa.eu/jrc/en/reference-materials/catalogue/

(e) Unique identifier:

KM-ØØØH71-4

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

Not applicable.

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

Not required.

(h) Monitoring plan for environmental effects:

Not applicable.

(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.