Commission Implementing Decision (EU) 2025/1321 of 4 July 2025 authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 87705 × MON 87708 × MON 89788 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2025) 4349)

• CELEX: Implementing Decision (EU) 2025/1321
• Articles: 11

Article 1 Genetically modified organism and unique identifier

Genetically modified soybean ( Glycine max (L.) Merr.) MON 87705 × MON 87708 × MON 89788, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1, in accordance with Regulation (EC) No 65/2004.

Article 2 Authorisation

The following products are authorised for the purposes of Article 4(2) and Article 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:

(a)

foods and food ingredients containing, consisting of or produced from genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;

(b)

feed containing, consisting of or produced from genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;

(c)

products containing or consisting of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 for uses other than those provided for in points (a) and (b), with the exception of cultivation.

Article 3 Labelling

1.   For the purposes of the 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.   For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products.

3.   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 MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 as referred to in Article 1, with the exception of products referred to in Article 2, point (a).

Article 4 Method for detection

The method set out in point (d) of the Annex shall apply for the detection of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1.

Article 5 Monitoring plan 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 6 Post-market monitoring

1.   The authorisation holder shall ensure that the post-market monitoring plan for genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1, as set out in point (i) 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 post-market monitoring plan.

Article 7 Community 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 8 Authorisation holder

The authorisation holder shall be Bayer CropScience LP, represented in the Union by Bayer Agriculture BV.

Article 9 Validity

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

Article 10 Addressee

This Decision is addressed to Bayer CropScience LP, 800 N. Lindbergh Boulevard St. Louis, Missouri 63167, United States, represented in the Union by Bayer Agriculture BV, Haven 627, Scheldelaan 460, 2040 Antwerp, Belgium.

Schedules & Appendices

ANNEX

ANNEX

(a)

Applicant and authorisation holder:

Name

:

Bayer CropScience LP;

Address

:

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

Represented in the Union by: Bayer Agriculture BV, Haven 627, 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 as referred to in point (e);

(2)

feed containing, consisting of or produced from genetically modified soybean as referred to in point (e);

(3)

products containing or consisting of genetically modified soybean as referred to in point (e) for uses other than those provided for in points (1) and (2), with the exception of cultivation.

The genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1, as described in the application, is produced by crosses between soybean containing MON-877Ø5-6, MON-877Ø8-9 and MON-89788-1 events. MON-877Ø5-6 produces dsRNAs which downregulate endogenous fatty acid Δ12-desaturase (FAD2) and palmitoyl acyl carrier protein thioesterase (FATB) enzymes; MON-877Ø8-9 expresses the DMO protein and MON-89788-1 expresses the CP4 EPSPS protein. This combination confers an altered fatty acid profile (increased oleic acid and reduced linoleic acid content), and tolerance to herbicides containing glyphosate and to herbicides containing dicamba.

(c)

Labelling:

(1)

For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’;

(2)

For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products;

(3)

The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified soybean referred to in point (e), with the exception of the products referred to in point (b)(1).

(d)

Method for detection:

(1)

The quantitative event-specific PCR detection methods are those individually validated for genetically modified soybean MON-877Ø5-6, MON-877Ø8-9 and MON-89788-1 and further verified on soybean stack MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1.

(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: AOCS 0210-A (for MON87705), AOCS 0311-A (for MON87708) and AOCS 0906-B (for MON 89788) are accessible via the American Oil Chemists Society at https://www.aocs.org/crm .

(e)

Unique identifier:

MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1.

(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.

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

(i)

Post-market monitoring plan:

1.

The authorisation holder shall collect the following information:

(i)

quantities of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 for oil extraction, imported into the European Union for the placing on the market as or in products for food;

(ii)

In case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.

2.

The authorisation holder shall, based on the information collected and reported:

(i)

review the predicted consumption data of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;

(ii)

verify that the conditions of use of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 are those considered during the pre-market risk assessment.

Note:

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