Commission Implementing Decision (EU) 2025/2554

Contents

Article 1Genetically modified organism and unique identifier#

Genetically modified soybean (Glycine max (L.) Merr.) MON 87708, as specified in point (b) the Annex, is assigned the unique identifier MON-877Ø8-9, in accordance with Regulation (EC) No 65/2004.

Article 2Renewal of the authorisation#

The authorisation for the placing on the market of the following products is renewed as regards:

(a)foods and food ingredients containing, consisting of or produced from genetically modified soybean MON-877Ø8-9;

(b)feed containing, consisting of or produced from genetically modified soybean MON-877Ø8-9;

(c)products containing or consisting of genetically modified soybean MON-877Ø8-9, for uses other than those provided for in points (a) and (b), with the exception of cultivation.

Article 3Labelling#

1.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 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 the documents accompanying the products containing or consisting of genetically modified soybean, referred to in Article 1, with the exception of products referred to in Article 2, point (a).

Article 4Method for detection#

The method set out in point (d) of the Annex shall apply for the detection of genetically modified soybean MON-877Ø8-9.

Article 5Monitoring for environmental effects#

1.The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.

2.The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with the format set out in Decision 2009/770/EC.

Article 6Community 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(1) of Regulation (EC) No 1829/2003.

Article 7Authorisation holder#

The authorisation holder shall be Bayer CropScience LLC, United States, represented in the Union by Bayer Agriculture B.V., Belgium.

Article 8Validity#

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

Article 9Addressee#

This Decision is addressed to 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.

(a)Applicant and authorisation holder:Name: Bayer CropScience LLCAddress: 800 N. Lindbergh Boulevard St. Louis, Missouri 63167, United States,represented in the Union by: Bayer Agriculture B.V., Scheldelaan 460, 2040 Antwerp, Belgium.

(b)Designation and specification of the products:

(1)foods and food ingredients containing, consisting of or produced from genetically modified soybean MON-877Ø8-9;

(2)feed containing, consisting of or produced from genetically modified soybean MON-877Ø8-9;

(3)products containing or consisting of genetically modified soybean MON-877Ø8-9 for uses other than those provided for in points (1) and (2), with the exception of cultivation.

The genetically modified soybean MON-877Ø8-9 expresses the dmo gene, which confers tolerance to dicamba-based herbicides.

(c)Labelling:

(1)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, 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 the documents accompanying the products containing or consisting of the genetically modified soybean MON-877Ø8-9, with the exception of the products referred to in point (b)(1).

(d)Method for detection:

(1)Event specific real-time PCR based method for the quantification of genetically modified soybean MON-877Ø8-9;

(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 0311-A (for MON-877Ø8-9) and AOCS 0906-A (for the non-GM counterpart) is accessible via the American Oil Chemists Society (AOCS), at https://www.aocs.org/crm?SSO=True.

(e)Unique identifier:MON-877Ø8-9

(f)Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:[Biosafety Clearing-House, Record ID number: published in the Community register of genetically modified food and feed when notified].

(g)Conditions or restrictions on the placing on the market, use or handling of the products:Not required.

(h)Monitoring plan for environmental effects:Monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC of the European Parliament and of the Council^note.

*[Link: plan published in the Community register of genetically modified food and feed]

(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 via the updating of the Community register of genetically modified food and feed.