Commission Implementing Decision (EU) 2021/1386 of 17 August 2021 authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean DAS-81419-2 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2021) 5993) (Only the Dutch text is authentic) (Text with EEA relevance)

• CELEX: Implementing Decision (EU) 2021/1386
• Articles: 10

Article 1 Genetically modified organism and unique identifier

Genetically modified soybean ( Glycine max (L.) Merr.) DAS-81419-2, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier DAS-81419-2, 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 DAS-81419-2;

(b)

feed containing, consisting of or produced from genetically modified soybean DAS-81419-2;

(c)

products containing or consisting of genetically modified soybean DAS-81419-2 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.   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 DAS-81419-2 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 DAS-81419-2.

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 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 7 Authorisation holder

The authorisation holder shall be Corteva Agriscience LLC represented in the Union by Corteva Agriscience Belgium B.V.

Article 8 Validity

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

Article 9 Addressee

This Decision is addressed to Corteva Agriscience LLC, 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States of America, represented by Corteva Agriscience Belgium B.V., Bedrijvenlaan 9, 2800 Mechelen, Belgium.

Schedules & Appendices

ANNEX

ANNEX

(a)

Applicant and authorisation holder:

Name: Corteva Agriscience LLC

Address: 9330 Zionsville Road, Indianapolis, IN 46268-1054, United States

Represented in the Union by: Corteva Agriscience Belgium B.V., Bedrijvenlaan 9, 2800 Mechelen, Belgium.

(b)

Designation and specification of the products:

(1)

foods and food ingredients containing, consisting of or produced from genetically modified soybean DAS-81419-2;

(2)

feed containing, consisting of or produced from genetically modified soybean DAS-81419-2;

(3)

products containing or consisting of genetically modified soybean DAS-81419-2 for uses other than those provided for in points (1) and (2), with the exception of cultivation.

The genetically modified soybean DAS-81419-2 expresses the synthetic cry1Fv3 gene and the synthetic cry1Ac gene, which confer protection against certain lepidopteran pests. In addition, the pat gene, conferring tolerance to glufosinate-ammonium-based herbicide, was used as a selection marker in the genetic modification process.

(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)

The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of soybean DAS-81419-2, with the exception of products referred to in point (b)(1).

(d)

Method for detection:

(1)

Event specific real-time quantitative PCR based method for detection of the genetically modified soybean DAS-81419-2;

(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: ERM ® -BF437 is accessible via the Joint Research Centre (JRC) of the European Commission at https://ec.europa.eu/jrc/en/reference-materials/catalogue.

(e)

Unique identifier:

DAS-81419-2

(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  ( 1 )

[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 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.

( 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 ).