Commission Implementing Decision (EU) 2026/457

Contents

THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed^note, and in particular Article 7(3) and Article 19(3) thereof,Whereas:

(1)On 30 May 2023, Bayer Agriculture B.V., based in Belgium, on behalf of Bayer CropScience LP, based in the United States, and KWS SAAT SE & Co. KGaA, based in Germany, (‘the applicants’) submitted an application to the national competent authority of the Netherlands for the placing on the market of food, food ingredients and feed produced from genetically modified sugar beet KWS20-1, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 (‘the application’).

(2)On 12 May 2025, the European Food Safety Authority (‘the Authority’) issued a favourable scientific opinion^note on genetically modified sugar beet KWS20-1 in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. The Authority concluded that genetically modified sugar beet KWS20-1, as described in the application, is as safe as its conventional counterpart and the tested non-genetically modified sugar beet reference varieties with respect to the potential effects on human and animal health and the environment. The Authority also concluded that the consumption of food and feed produced from genetically modified sugar beet KWS20-1 does not represent any nutritional concern.

(3)In its scientific opinion, the Authority considered all the questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for in Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(4)Taking into account those conclusions, the placing on the market of food, food ingredients and feed produced from genetically modified sugar beet KWS20-1 should be authorised for the uses listed in the application.

(5)By the letter of 19 January 2026, Bayer Agriculture B.V., based in Belgium, informed the Commission that Bayer CropScience LP converted its legal form and changed its name to Bayer CropScience LLC as of 1 January 2026.

(6)A unique identifier should be assigned to genetically modified sugar beet KWS20-1 in accordance with Commission Regulation (EC) No 65/2004^note.

(7)For the products covered by this Decision, no specific labelling requirements, other than those provided for in Article 13(1) and Article 25(2), points (a) and (b), of Regulation (EC) No 1829/2003, appear to be necessary.

(8)The opinion of the Authority does not justify the imposition of other specific conditions or restrictions for the placing on the market, for the use and handling of food, food ingredients and feed produced from genetically modified sugar beet KWS20-1, as provided for in Article 6(5), point (e), and Article 18(5), point (e), of Regulation (EC) No 1829/2003.

(9)All relevant information on the authorisation of the products covered by this Decision should be entered in the Community register of genetically modified food and feed referred to in Article 28(1) of Regulation (EC) No 1829/2003.

(10)The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

HAS ADOPTED THIS DECISION:

Article 1Genetically modified organism and unique identifier#

Genetically modified sugar beet (Beta vulgaris L.) KWS20-1, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier KB-KWS2Ø1-6, in accordance with Regulation (EC) No 65/2004.

Article 2Authorisation#

The following products are authorised in accordance with the conditions set out in this Decision:

(a)foods and food ingredients produced from genetically modified sugar beet KB-KWS2Ø1-6;

(b)feed produced from genetically modified sugar beet KB-KWS2Ø1-6.

Article 3Labelling#

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

Article 4Method for detection#

The method set out in point (d) of the Annex shall apply for the detection of genetically modified sugar beet KB-KWS2Ø1-6.

Article 5Community register#

The information set out in the Annex shall be entered in the Community register of genetically modified food and feed, as referred to in Article 28(1) of Regulation (EC) No 1829/2003.

Article 6Authorisation holders#

The authorisation holders shall be:

(a)Bayer CropScience LLC, represented in the Union by Bayer Agriculture B.V., Belgium;

(b)KWS SAAT SE & Co. KGaA, Germany.

Article 7Validity#

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

Article 8Addressee#

This Decision is addressed to:

(a)Bayer CropScience LLC, 800 N. Lindbergh Boulevard, St. Louis, Missouri, 63167, United States, represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040 Antwerp, Belgium;and

(b)KWS SAAT SE & Co. KGaA, Grimsehlstrasse 31, Einbeck, 37574, Germany.

(a)Applicants and authorisation holders:

(1)

Address:800 N. Lindbergh Boulevard, St Louis, Missouri, 63167, United States,

Name:Bayer CropScience LLC

represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040, Antwerp, Belgium;and

(2)

Address:Grimsehlstrasse 31, Einbeck, 37574, Germany.

Name:KWS SAAT SE & Co. KGaA

(b)Designation and specification of the products:

(1)foods and food ingredients produced from genetically modified sugar beet (Beta vulgaris L.) KB-KWS2Ø1-6;

(2)feed produced from genetically modified sugar beet (Beta vulgaris L.) KB-KWS2Ø1-6;

The genetically modified sugar beet KB-KWS2Ø1-6 expresses the dmo gene, which confers tolerance to herbicides containing dicamba, the pat gene, which confers tolerance to herbicides containing glufosinate-ammonium and the cp4 epsps gene, which confers tolerance to herbicides containing glyphosate.

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

(d)Method for detection:

(1)event-specific real-time PCR based method for the quantification of genetically modified sugar beet KB-KWS2Ø1-6;

(2)validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published at https://gmo-crl.jrc.ec.europa.eu/method-validations;

(3)reference material: AOCS 0523-B (for KB-KWS2Ø1-6) and AOCS 1206-A (for its non-GM counterpart), are accessible via the American Oil Chemists Society (AOCS), at https://www.aocs.org/crm?SSO=True.

(e)Unique identifier:KB-KWS2Ø1-6

(f)Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:Not required.

(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 required.

(i)Post-market monitoring requirements for the use of the food for human consumption:Not required.

Note:links to the relevant documents may need to be modified over time. Those modifications will be made available to the public through the updating of the Community register of genetically modified food and feed.