DAS-68416-4
EU register of genetically modified food and feed.
| Event | DAS-68416-4 |
| Authorisation holder Name | Corteva Agriscience LLC, United States, represented in the Union by Corteva Agriscience Belgium BV. |
| Authorisation holder Address | Corteva Agriscience LLC, 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States, represented in the Union by Corteva Agriscience Belgium BV, Bedrijvenlaan 9, 2800 Mechelen, Belgium |
| Products |
(1) Foods and food ingredients containing, consisting of, or produced from DAS-68416-4 soybean; (2) Feed containing, consisting of, or produced from DAS-68416-4 soybean; (3) Products, other than food and feed, containing or consisting of DAS-68416-4 soybean for the same uses as any other soybean with the exception of cultivation. |
| Designation | DAS-68416-4 soybean expresses the AAD-12 protein, which confers tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and other related phenoxy herbicides, and the PAT protein, which confers tolerance to glufosinate ammonium-based herbicides. |
| 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 products containing or consisting of DAS-68416-4 soybean and referred to in Article 2(b) and (c). |
| Method for detection |
(1) Event specific real-time quantitative PCR based method for DAS-68416-4 soybean; the detection method is validated on the single-trait event using genomic DNA extracted from seeds of DAS-68416-4 soybean;
(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. |
| Reference material | ERM®-BF432 accessible via the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/ |
| Unique identifier | DAS-68416-4 |
| Annex II to the Cartagena Protocol | http://bch.cbd.int/database/record.shtml?documentid=113273 |
| Conditions or restrictions on the placing on the market | Not required |
| Monitoring plan | |
| Post-market monitoring requirements | Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC. |
| Date of authorisation | 21/12/2017 |
| Legal base |
Art. 7(3) and Art. 19(3) of the Regulation (EC) No 1829/2003 Commission Implementing Decision (EU) 2017/2449 of 21 December 2017 Amended by Commission Implementing Decision (EU) 2019/239 of 6 February 2019 Amended by Commission Implementing Decision (EU) 2021/1161 of 13 July 2021 |
| Authorisation expiration date | 22/12/2027 |
| Further information on risk assessment |
Opinion of the European Food Safety Authority:
http://registerofquestions.efsa.europa.eu/roqFrontend/questionDocumentsLoader?question=EFSA-Q-2017-00067 |