02015D0698 — EN — 28.02.2022 — 001.001

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►B COMMISSION IMPLEMENTING DECISION (EU) 2015/698 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean 305423 (DP-3Ø5423-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2015) 2773) (Only the Dutch and French texts are authentic) (Text with EEA relevance) (OJ L 112 30.4.2015, p. 71)

Amended by:









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COMMISSION IMPLEMENTING DECISION (EU) 2015/698

of 24 April 2015

authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean 305423 (DP-3Ø5423-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document C(2015) 2773)

(Only the Dutch and French texts are authentic)

(Text with EEA relevance)







Article 1

Genetically modified organism and unique identifier

Genetically modified 305423 soybean (Glycine max (L.) Merr.), as specified in point (b) of the Annex to this Decision, is assigned the unique identifier DP-3Ø5423-1, as provided for in Regulation (EC) No 65/2004.

Article 2

Authorisation

The following products are authorised for the purposes of Articles 4(2) and 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 DP-3Ø5423-1 soybean;

(b) feed containing, consisting of, or produced from DP-3Ø5423-1 soybean;

(c) DP-3Ø5423-1 soybean in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

Article 3

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. For the purposes of the labelling requirements laid down in Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products.

3. The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of DP-3Ø5423-1 soybean with the exception of products referred to in point (a) of Article 2.

Article 4

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 Decision 2009/770/EC.

Article 5

Post-market monitoring in accordance with Article 6(5)(e) of Regulation (EC) No 1829/2003

1. The authorisation holder shall ensure that the post-market monitoring plan of the DP-3Ø5423-1 soybean oil, as set out in point (g) 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 post-market monitoring plan for the duration of the authorisation.

Article 6

Community register

The information set out in the Annex to this Decision 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.

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Article 7

Authorisation holder

The authorisation holder shall be Corteva Agriscience LLC, United States, represented in the Union by Corteva Agriscience Belgium BV.

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Article 8

Validity

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

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Article 9

Addressee

This Decision is addressed to 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.

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ANNEX

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(a) Applicant and authorisation holder

Name : Corteva Agriscience LLC

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

Represented in the Union by Corteva Agriscience Belgium BV, Bedrijvenlaan 9, 2800 Mechelen, Belgium.

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(b) Designation and specification of the products

1. Foods and food ingredients containing, consisting of, or produced from DP-3Ø5423-1 soybean.

2. Feed containing, consisting of, or produced from DP-3Ø5423-1 soybean.

3. DP-3Ø5423-1 soybean in products containing it or consisting of it for any other use than 1 and 2, with the exception of cultivation.

The genetically modified DP-3Ø5423-1 soybean, as described in the application, has a reduced expression of the soybean enzyme omega-6 desaturase, which results in a high oleic acid and reduced linoleic acid profile, and expresses an optimised Glycine max-hra gene, which confers tolerance to acetolactate synthase-inhibiting herbicides.

(c) Labelling

1. For the purposes of the specific 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. For the purposes of the labelling requirements laid down in Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products.

3. The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of DP-3Ø5423-1 soybean with the exception of products referred to in point (a) of Article 2.

(d) Method for detection

— Event specific real-time PCR based method for the quantification of DP-3Ø5423-1 soybean.

— Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003 on genomic DNA extracted from soybean seeds, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx

— Reference Material: ERM-BF426 accessible via the Joint Research Centre (JRC) of the European Commission, the Institute for Reference Materials and Measurements (IRMM) at http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm

(e) Unique identifier

DP-3Ø5423-1

(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity

Biosafety Clearing-House, Record ID: see [to be completed when notified].

(g) Conditions or restrictions on the placing on the market, use or handling of the products

Post-market monitoring in accordance with Article 6(5)(e) of Regulation (EC) No 1829/2003

1. The authorisation holder shall collect the following information: (i) quantities of DP-3Ø5423-1 soybean oil and 305423 soybeans for oil extraction, imported into the European Union for the placing on the market as or in products for food; (ii) in case of import of products mentioned under (i), results of database searches in FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.

2. The authorisation holder shall, based on the information collected and reported, review the nutritional assessment conducted as part of the risk assessment.

(h) Monitoring plan for environmental effects

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

[Link: plan published on the internet]

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.