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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
32025D1321
Document type
DEC_IMPL
Sector
Legislation
Date of document
2025-07-04
In force since
2025-07-07
End of validity
2035-07-07
Status
In force

Text

Article-level text, parsed from the formex manifestation.

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.

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