
Article 1 
Genetically modified soybean (Glycine max (L.) Merr.) DAS-68416-4, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier DAS-68416-4, in accordance with Regulation (EC) No 65/2004.
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 soybean DAS-68416-4;
((b)) feed containing, consisting of, or produced from soybean DAS-68416-4;
((c)) soybean DAS-68416-4 in products containing it or consisting of it for any other use than those provided in points (a) and (b), with the exception of cultivation.
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 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 the product and in the documents accompanying products containing or consisting of genetically modified soybean DAS-68416-4, with the exception of products referred to in Article 2(a).
Article 4 

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 annual reports on the implementation and the results of the activities set out in the monitoring plan to the Commission in accordance with Decision 2009/770/EC.
Article 5 
The method set out in point (d) of the Annex shall apply for the detection of soybean DAS-68416-4.
Article 6 
The information set out in the Annex shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.
Article 7 
The authorisation holder shall be Dow AgroSciences Europe on behalf of Dow AgroSciences LLC.
Article 8 
This Decision shall apply for a period of 10 years from the date of its notification.
Article 9 
This Decision is addressed to Dow AgroSciences Europe, European Development Centre, 3 Milton Park, Abingdon, Oxon OX14 4RN, United Kingdom.
Done at Brussels, 21 December 2017.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
ANNEX
(a) 
NameDow AgroSciences EuropeAddressEuropean Development Centre, 3 Milton Park, Abingdon, Oxon OX14 4RN, United Kingdom.

On behalf of

Dow AgroSciences LLC, 9330 Zionsville Road Indianapolis, Indiana 46268-1054, USA

(b) 

((1)) foods and food ingredients containing, consisting of, or produced from soybean DAS-68416-4;
((2)) feed containing, consisting of, or produced from soybean DAS-68416-4;
((3)) soybean DAS-68416-4 in products containing it or consisting of it for any other use than those provided in points (1) and (2), with the exception of cultivation.

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.

(c) 

((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 the products and in the accompanying documents of the products containing or consisting of soybean DAS-68416-4 with the exception of products referred to in point (a) of Article 2.

(d) 

((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
((3)) Reference Material: ERM®-BF432 accessible via the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/.

(e) 
DAS-68416-4;

(f) 
[Biosafety Clearing-House, Record ID number: published in the Community register of genetically modified food and feed when notified].

(g) 
Not required

(h) 
Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

[Link: plan published in the Community register of genetically modified food and feed]

(i) 
Not required.
Note: links to relevant documents may need to be modified over the time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.