Commission Implementing Decision (EU) 2022/529 of 31 March 2022 authorising the placing on the market of products containing, consisting of or produced from genetically modified oilseed rape 73496 (DP-Ø73496-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2022) 1868) (Only the Dutch text is authentic) (Text with EEA relevance)

• CELEX: Implementing Decision (EU) 2022/529
• Articles: 11

Article 1 Genetically modified organism and unique identifier

Genetically modified oilseed rape ( Brassica napus L.) 73496, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier DP-Ø73496-4, in accordance with Regulation (EC) No 65/2004.

Article 2 Authorisation

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 oilseed rape DP-Ø73496-4;

(b)

feed containing, consisting of or produced from genetically modified oilseed rape DP-Ø73496-4;

(c)

products containing or consisting of genetically modified oilseed rape DP-Ø73496-4 for uses other than those provided for in points (a) and (b), with the exception of cultivation.

Article 3 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 ‘oilseed rape’.

2.   The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying the products containing or consisting of genetically modified oilseed rape DP-Ø73496-4 as referred to in Article 1, with the exception of products referred to in Article 2, point (a).

Article 4 Method for detection

The method set out in point (d) of the Annex shall apply for the detection of genetically modified oilseed rape DP-Ø73496-4.

Article 5 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 the format set out in Decision 2009/770/EC.

Article 6 Post-market monitoring

1.   The authorisation holder shall ensure that the post-market monitoring plan for genetically modified oilseed rape DP-Ø73496-4, as set out in point (i) 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.

Article 7 Community register

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.

Article 8 Authorisation holder

The authorisation holder shall be Corteva Agriscience LLC, represented in the Union by Corteva Agriscience Belgium B.V.

Article 9 Validity

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

Article 10 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 B.V., Bedrijvenlaan 9, 2800 Mechelen, Belgium.

Schedules & Appendices

ANNEX

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 oilseed rape DP-Ø73496-4;

(2)

feed containing, consisting of or produced from genetically modified oilseed rape DP-Ø73496-4;

(3)

products containing or consisting of genetically modified oilseed rape DP-Ø73496-4 for uses other than those provided for in points (1) and (2), with the exception of cultivation.

The genetically modified oilseed rape DP-Ø73496-4 expresses the gat4621 gene, which confers tolerance to glyphosate-based herbicides.

(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 ‘oilseed rape’.

(2)

The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of oilseed rape DP-Ø73496-4, with the exception of products referred to in point (b)(1).

(d)

Method for detection:

(1)

Event specific real-time quantitative PCR based method for detection of the genetically modified oilseed rape DP-Ø73496-4;

(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 ® -BF434 is accessible via the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/

(e)

Unique identifier:

DP-Ø73496-4

(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

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

(i)

Post-market monitoring plan:

1.

The authorisation holder shall collect the following information:

(i)

quantities of genetically modified oilseed rape DP-Ø73496-4 imported into the Union for the placing on the market and of products derived from genetically modified oilseed rape DP-Ø73496-4 for food and for feed;

(ii)

in case of import, consumption data for humans and animals of genetically modified oilseed rape DP-Ø73496-4 and of products derived from genetically modified oilseed rape DP-Ø73496-4 for food and for feed.

2.

The authorisation holder shall, based on the information collected and reported:

(i)

review the predicted consumption data of genetically modified oilseed rape DP-Ø73496-4;

(ii)

verify that the conditions of use of genetically modified oilseed rape DP-Ø73496-4 are those considered during the pre-market risk assessment.

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.