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Commission Implementing Decision (EU) 2021/1387 of 17 August 2021 authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean DAS-81419-2 × DAS–44406–6, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2021)5994) (Only the Dutch text is authentic) (Text with EEA relevance)

Commission Implementing Decision (EU) 2021/1387 of 17 August 2021 authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean DAS-81419-2 × DAS–44406–6, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2021)5994) (Only the Dutch text is authentic) (Text with EEA relevance)

Implementing Decision (EU) 2021/1387 · Decision · 10 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Genetically modified organism and unique identifier

Article 1

Genetically modified soybean ( Glycine max (L.) Merr) DAS-81419-2 × DAS–44406–6, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier DAS-81419-2 × DAS-444Ø6-6, in accordance with Regulation (EC) No 65/2004.

Authorisation

Article 2

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 × DAS-444Ø6-6; (b) feed containing, consisting of or produced from genetically modified soybean DAS-81419-2 × DAS-444Ø6-6; (c) products containing or consisting of genetically modified soybean DAS-81419-2 × DAS-444Ø6-6 for uses other than those provided for in points (a) and (b), with the exception of cultivation.

Labelling

Article 3

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 products containing or consisting of genetically modified soybean DAS-81419-2 × DAS-444Ø6-6, as referred to in Article 1, with the exception of products referred to in Article 2, point (a).

Method for detection

Article 4

The method set out in point (d) of the Annex shall apply for the detection of genetically modified soybean DAS-81419-2 × DAS-444Ø6-6.

Monitoring for environmental effects

Article 5

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.

Community register

Article 6

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.

Authorisation holder

Article 7

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

Validity

Article 8

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

Addressee

Article 9

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.

Supplementary provisions

ANNEXSupplementary provisions

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 × DAS-444Ø6-6; (2) feed containing, consisting of or produced from genetically modified soybean DAS-81419-2 × DAS-444Ø6-6; (3) products containing or consisting of genetically modified soybean DAS-81419-2 × DAS-444Ø6-6 for uses other than those provided for in points (1) and (2), with the exception of cultivation. The genetically modified soybean DAS-81419-2 × DAS-444Ø6-6 expresses the 2mepsps gene, which confers tolerance to glyphosate-based herbicides, the aad-12 gene, which confers tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and other related phenoxy herbicides, the pat gene, which confers tolerance to glufosinate-ammonium based herbicides and the synthetic cry1F and cry1Ac genes, which confer protection against certain lepidopteran pests. (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 × DAS–444Ø6–6, 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 events DAS-81419-2 and DAS-444Ø6-6 and further verified on soybean stack DAS-81419-2 × DAS-444Ø6-6; (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 (for DAS-81419-2) and ERM®-BF436 (for DAS-444Ø6-6) are 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 × DAS-444Ø6-6 (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: 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 ).

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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