Genetically Modified Organisms

DAS-81419-2

EU register of genetically modified food and feed.

Event DAS-81419-2
Authorisation holder Name Corteva Agriscience LLC
Authorisation holder Address 9330 Zionsville Road,
Indianapolis, IN 46268-1054,
United States of America

Represented in the Union by Corteva Agriscience Belgium B.V., Bedrijvenlaan 9, 2800 Mechelen, Belgium.
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.
Designation 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.
Labelling (1) For the purposes of the labelling requirements laid down in Articles 13(1) and 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 genetically modified soybean DAS-81419-2, with the exception of products referred to in point (b)(1)
Method for detection - Event specific real-time quantitative PCR based method for detection of the genetically modified soybean DAS-81419-2.

- Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published at https://gmo-crl.jrc.ec.europa.eu/method-validations
Reference material Reference Material: ERM®-BF437 is accessible via the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/
Unique identifier DAS-81419-2
Annex II to the Cartagena Protocol https://bch.cbd.int/database/record.shtml?documentid=116341
Conditions or restrictions on the placing on the market Not applicable
Post-market monitoring requirements Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC
Date of authorisation 18/08/2021
Legal base Commission Implementing Decision 2021/1386(EU) of 17 August 2021
Authorisation expiration date 17/08/2031
Further information on risk assessment Opinions of the European Food Safety Authority:
https://doi.org/10.2903/j.efsa.2016.4642
Version: 1.1.3