Commission Implementing Decision (EU) 2026/1419 of 29 June 2026 renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 87705 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2026) 4402)

• CELEX: Implementing Decision (EU) 2026/1419
• Articles: 11

Article 1 Genetically modified organism and unique identifier

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

Article 2 Renewal 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-877Ø5-6;

(b)

feed containing, consisting of or produced from genetically modified soybean MON-877Ø5-6;

(c)

products containing or consisting of genetically modified soybean MON-877Ø5-6, 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), 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.   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 the genetically modified soybean, 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.

Article 5 Monitoring 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 in accordance with Article 6(5)(e) of Regulation (EC) No 1829/2003

1.   The authorisation holder shall ensure that the post-market monitoring plan of the MON-877Ø5-6 soybean oil, as set out in point (g) 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 for the duration of the authorisation.

Article 7 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(1) of Regulation (EC) No 1829/2003.

Article 8 Authorisation holder

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

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 LLC, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States, represented in the Union by Bayer Agriculture BV, Scheldelaan 460, 2040, Antwerp, Belgium.

Schedules & Appendices

ANNEX

ANNEX

(a)

Applicant and authorisation holder:

Name

:

Bayer CropScience LLC

Address

:

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-877Ø5-6;

(2)

feed containing, consisting of or produced from genetically modified soybean MON-877Ø5-6;

(3)

products containing or consisting of genetically modified soybean MON-877Ø5-6, for uses other than those provided for in points (1) and (2), with the exception of cultivation.

The genetically modified soybean MON-877Ø5-6 has a reduced expression of fatty acid Δ12-desaturase (FAD2) and palmitoyl acyl carrier protein thioesterase (FATB) enzymes, which results in an increased oleic acid and a reduced linoleic acid profile and expresses the CP4 EPSPS protein, which confers tolerance to glyphosate-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)

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 the genetically modified soybean MON-877Ø5-6, 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-877Ø5-6;

(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 0210-A2 (for MON-877Ø5-6) and AOCS 0906-A (for the non-GM counterpart) are accessible through the American Oil Chemists Society (AOCS), at https://www.aocs.org/

(e)

Unique identifier:

MON-877Ø5-6

(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:

Post-market monitoring in accordance with Article 6(5)(e) of Regulation (EC) No 1829/2003

1.

The authorisation holder shall collect the following information:

(i)

quantities of MON-877Ø5-6 soybean oil and MON-877Ø5-6 soybeans 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, review the nutritional assessment conducted as part of the risk assessment.

(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  ( *1 ) .

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

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.

( *1 )   Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC ( OJ L 106, 17.4.2001, p. 1 , ELI:  http://data.europa.eu/eli/dir/2001/18/oj ).