Commission Implementing Decision (EU) 2022/798 of 19 May 2022 authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 87769 × MON 89788 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2022) 3182) (Only the Dutch text is authentic) (Text with EEA relevance)

• CELEX: Implementing Decision (EU) 2022/798
• Articles: 11

Article 1 Genetically modified organism and unique identifier

Genetically modified soybean ( Glycine max (L.) Merr.) MON 87769 × MON 89788, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-87769-7 × 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-87769-7 × MON-89788-1;

(b)

feed containing, consisting of or produced from genetically modified soybean MON-87769-7 × MON-89788-1;

(c)

products containing or consisting of genetically modified soybean MON-87769-7 × 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 stearidonic acid’ 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 products containing or consisting of genetically modified soybean MON-87769-7 × MON-89788-1, 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-87769-7 × MON-89788-1.

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 genetically modified soybean MON-87769-7 × MON-89788-1 and its products, in particular its refined bleached deodorised oil, 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 for the duration of the authorisation.

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, Scheldelaan 460, BE-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, 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-87769-7 × MON-89788-1;

(2)

feed containing, consisting of or produced from genetically modified soybean MON-87769-7 × MON-89788-1;

(3)

products containing or consisting of genetically modified soybean MON-87769-7 × MON-89788-1 for uses other than those provided for in points (1) and (2), with the exception of cultivation.

The genetically modified soybean MON-87769-7 expresses Δ15 desaturase which results in conversion of linoleic acid to α-linolenic acid and Δ6 desaturase which results in conversion of α-linolenic to stearidonic acid (SDA). SDA is a normal intermediate in the formation of the long-chain omega-3 polyunsaturated fatty acids.

The genetically modified soybean MON-89788-1 expresses the cp4 epsps gene, which confers tolerance to glyphosate-containing herbicides.

(c)    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 stearidonic acid’ 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 soybean specified in point (e), with the exception of 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-87769-7 and MON-89788-1 and further verified on soybean stack MON-87769-7 × 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 0809 (for MON-87769-7), and AOCS 0906 (for MON-89788-1) are accessible via the American Oil Chemists Society at https://www.aocs.org/crm.

(e)    Unique identifier:

MON-87769-7 × 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 requirements for the use of the food for human consumption:

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 genetically modified soybean MON-87769-7 × MON-89788-1 for oil extraction, imported into the Union for their placing on the market;

(ii)

quantities of genetically modified soybean MON-87769-7 × MON-89788-1 oil, imported into the European Union for the placing on the market, in particular, quantities of refined bleached deodorised oil, and;

(iii)

quantities of products for food containing this refined bleached deodorised oil, imported into the European Union for the placing on the market;

(iv)

in case of import, consumption data for humans of products listed in points (i) to (iii).

(2)

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

(i)

review the predicted consumption data of genetically modified soybean MON-87769-7 × MON-89788-1;

(ii)

verify that the conditions of use of genetically modified soybean MON-87769-7 × 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 via the updating of the Community register of genetically modified food and feed.