Date: 2025-04-11Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2025/699 of 9 April 2025 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize DP910521 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2025) 2114)
Issued by European Commission
· Directorate-General for Health and Food Safety
## Policy Analysis Report: Commission Implementing Decision (EU) 2025/699 Regarding Genetically Modified Maize DP910521
**1. Executive Summary:**
This report analyzes Commission Implementing Decision (EU) 2025/699 of April 9, 2025, which authorizes the placing on the market of products containing, consisting of, or produced from genetically modified maize DP910521. This new policy, based on a favorable scientific opinion from the European Food Safety Authority (EFSA), permits the use of this GM maize in food, feed, and other products (excluding cultivation) within the European Union. Key findings indicate specific labeling requirements (particularly regarding non-cultivation use), a mandatory monitoring plan for environmental effects, and the assignment of a unique identifier (DP915212) for the GM maize. This report provides an overview for affected industry stakeholders.
**2. Introduction:**
The purpose of this report is to provide an informative analysis of Commission Implementing Decision (EU) 2025/699, based solely on the provided text. This analysis aims to clarify the decision's key provisions, potential impact, and relevant implementation aspects for stakeholders in the affected industry.
**3. Policy Overview:**
* This is a *new* policy.
* **Core Objective(s):** To authorize the placing on the market of products containing, consisting of, or produced from genetically modified maize DP910521 within the EU, ensuring its safe use for human and animal health and the environment, while adhering to labeling and monitoring requirements.
**4. Background and Rationale:**
As a new policy, this decision likely addresses the increasing prevalence of genetically modified crops globally and the need for a standardized EU approval process based on scientific risk assessment. The application by Corteva Agriscience and EFSA's favorable opinion suggest the policy aims to balance innovation in agriculture with public safety and environmental concerns. The fact that the Standing Committee on Plants, Animals, Food and Feed did not deliver an opinion suggests that there were potentially concerns that required further deliberation via the appeal committee.
**5. Key Provisions / Changes:**
As this is a *new* policy, this section will detail the main components and rules:
* **Authorization:** The decision authorizes the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from genetically modified maize DP910521 (identified as DP915212). It also authorizes products containing or consisting of this GM maize for uses other than food and feed, explicitly excluding cultivation.
* **Unique Identifier:** The GM maize is assigned the unique identifier DP915212.
* **Labelling:** Standard labelling requirements apply as per Regulation EC No 1829/2003 and Regulation EC No 1830/2003. Crucially, products containing or consisting of GM maize DP910521, *except* for foods and food ingredients, must be labeled with the words "not for cultivation."
* **Detection Method:** A specific event-specific real-time PCR based method is specified for the detection of DP915212, validated by the EU reference laboratory. Reference materials are available via the American Oil Chemists Society (AOCS).
* **Monitoring Plan:** The authorization holder is required to implement a monitoring plan for environmental effects, as per Annex VII to Directive 2001/18/EC. Annual reports on the implementation and results of this monitoring plan must be submitted to the Commission.
* **Community Register:** All relevant information regarding the authorization will be entered into the Community register of genetically modified food and feed.
* **Authorization Holder:** Corteva Agriscience LLC is designated as the authorization holder, represented in the Union by Corteva Agriscience Belgium B.V.
* **Validity:** The decision is valid for a period of 10 years from the date of its notification.
**6. Target Audience and Stakeholders:**
Based on the provided text, the primary target audience and stakeholders include:
* **Corteva Agriscience LLC and Corteva Agriscience Belgium B.V.:** As the applicant and authorization holder, they are directly responsible for compliance with the decision's provisions, including labeling, monitoring, and reporting requirements.
* **Food and Feed Producers and Manufacturers:** Companies involved in the production, processing, and distribution of food and feed products containing, consisting of, or produced from GM maize DP910521 are directly affected by the authorization and labelling regulations.
* **Traders and Distributors:** Those involved in the import and export of products containing GM maize DP910521 must adhere to labeling and traceability requirements.
* **EU Reference Laboratory:** Responsible for validating the detection method.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** The European Commission is the issuing body. The European Food Safety Authority (EFSA) plays a key role in risk assessment. The EU Reference Laboratory is responsible for validating the detection method.
* **Timelines/Procedures:** The decision is effective for 10 years from the date of notification. Corteva Agriscience is required to submit annual reports on the environmental monitoring plan.
* The authorization holder has the responsibility to implement and ensure compliance with all provisions of the decision.
**8. Expected Outcomes / Impact of Changes:**
* The intended outcome is to facilitate the controlled introduction of GM maize DP910521 into the EU market for specific uses (food, feed, and other non-cultivation products).
* The decision aims to ensure transparency and traceability through labeling requirements and the community register.
* The environmental monitoring plan seeks to identify and mitigate any potential adverse effects of the GM maize on the environment.
* The policy is expected to have an economic impact on Corteva Agriscience by allowing them to market their GM maize products within the EU. It may also impact the competitiveness of EU agriculture depending on the adoption and acceptance of this GM maize.
**9. Conclusion:**
Commission Implementing Decision (EU) 2025/699 represents a significant step in the EU's regulatory framework for genetically modified organisms. It authorizes the use of GM maize DP910521 under specific conditions, emphasizing safety, traceability, and environmental monitoring. Industry stakeholders must understand and comply with the labeling and reporting requirements outlined in the decision to ensure continued access to the EU market for products containing this GM maize. The 10-year validity period necessitates continuous monitoring and adherence to the environmental plan to maintain authorization.
Key Entities Referenced
COMMISSION IMPLEMENTING DECISION EU 2025/699: An implementing decision of the European Commission.
Regulation EC No 1829/2003: Regulation of the European Parliament and of the Council on genetically modified food and feed.
European Parliament: Legislative branch of the European Union.
Council: Council of the European Union.
Corteva Agriscience Belgium B.V.: Company based in Belgium.
Corteva Agriscience LLC: Company based in the United States.
Netherlands: Member state of the European Union where the application was submitted.
Directive 2001/18/EC: Directive of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms.
European Food Safety Authority: An authority that issued a favourable scientific opinion.
Commission Regulation EC No 65/2004: Commission Regulation establishing a system for the development and assignment of unique identifiers for genetically modified organisms.
Regulation EC No 1830/2003: Regulation of the European Parliament and of the Council concerning the traceability and labelling of genetically modified organisms.
Commission Decision 2009/770/EC: Commission Decision establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms.
Regulation EC No 1946/2003: Regulation of the European Parliament and of the Council on transboundary movements of genetically modified organisms.
Standing Committee on Plants, Animals, Food and Feed: Committee that did not deliver an opinion within the time limit.
Treaty on the Functioning of the European Union: Treaty on which the decision is based.
Article 13(1): Article related to labelling requirements in Regulation EC No 1829/2003
Article 25(2): Article related to labelling requirements in Regulation EC No 1829/2003
Article 46: Article related to labelling requirements in Regulation EC No 1830/2003
Biosafety ClearingHouse: Mechanism for information exchange under the Cartagena Protocol.
DP910521: Genetically modified maize
Official Journal EN
of the European Union L series
2025/699 11.4.2025
COMMISSION IMPLEMENTING DECISION (EU) 2025/699
of 9 April 2025
authorising the placing on the market of products containing, consisting of or produced from
genetically modified maize DP910521 pursuant to Regulation (EC) No 1829/2003 of the European
Parliament and of the Council
(notified under document C(2025) 2114)
(Only the Dutch and French texts are authentic)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003on
genetically modified food and feed(1), and in particular Article 7(3) and Article 19(3) thereof,
Whereas:
(1) On 27 June 2022, Corteva Agriscience Belgium B.V., based in Belgium, on behalf of Corteva Agriscience LLC, based
in the United States, submitted an application to the national competent authority of the Netherlands for the placing
on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified
maize DP910521, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 (‘the application’). The
application also covered the placing on the market of products containing or consisting of genetically modified
maize DP910521 for uses other than food and feed, with the exception of cultivation.
(2) Pursuant to Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application included information
and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to
Directive 2001/18/EC of the European Parliament and of the Council(2). It also included the information required
pursuant to Annexes III and IV to that Directive and a monitoring plan for environmental effects in accordance with
Annex VII to that Directive.
(3) On 1 August 2024, the European Food Safety Authority (‘the Authority’) issued a favourable scientific opinion on
genetically modified maize DP910521 in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003(3).
The Authority concluded that genetically modified maize DP910521, as described in the application, is as safe as its
conventional counterpart and the tested non-genetically modified maize reference varieties with respect to the
potential effects on human and animal health and the environment. The Authority also concluded that the
consumption of genetically modified maize DP910521 does not represent any nutritional concern.
(4) In its scientific opinion, the Authority considered all the questions and concerns raised by the Member States in the
context of the consultation of the national competent authorities as provided for in Article 6(4) and Article 18(4) of
Regulation (EC) No 1829/2003.
(5) The Authority also concluded that the monitoring plan for the environmental effects, submitted by the applicant,
consisting of a general surveillance plan, is in line with the intended uses of the products.
(1) OJ L 268, 18.10.2003, p. 1, ELI: http://data.europa.eu/eli/reg/2003/1829/oj.
(2) Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment
of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1, ELI: http://data.europa.eu/
eli/dir/2001/18/oj).
(3) EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2024. Scientific Opinion on the assessment of genetically modified
maize DP910521 (application GMFF-2021-2473). EFSA Journal 2024; 22(8):8887; https://doi.org/10.2903/j.efsa.2024.8887.
ELI: http://data.europa.eu/eli/dec_impl/2025/699/oj 1/6EN
OJ L, 11.4.2025
(6) Taking into account those conclusions, the placing on the market of products containing, consisting of or produced
from genetically modified maize DP910521 should be authorised for the uses listed in the application.
(7) A unique identifier should be assigned to genetically modified maize DP910521 in accordance with Commission
Regulation (EC) No 65/2004(4).
(8) For the products covered by this Decision, no specific labelling requirements, other than those provided for 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 of the European Parliament and of the Council(5), appear to be necessary. However, in order to
ensure that the use of those products remains within the limits of the authorisation granted by this Decision, the
labelling of the products containing or consisting of genetically modified maize DP910521, with the exception of
foods and food ingredients, should contain a clear indication that they are not intended for cultivation.
(9) The authorisation holder should submit annual reports on the implementation and on the results of the activities set
out in the monitoring plan for environmental effects. Those results should be presented in accordance with the
requirements laid down in Commission Decision 2009/770/EC(6).
(10) The opinion of the Authority does not justify the imposition of other specific conditions or restrictions for the
placing on the market, for the use and handling of food and feed containing, consisting of or produced from
genetically modified maize DP910521 or for the protection of particular ecosystems/environment and/or
geographical areas, as provided for in Article 6(5), point (e), and Article 18(5), point (e), of Regulation (EC)
No 1829/2003.
(11) All relevant information on the authorisation of the products covered by this Decision should be entered in the
Community register of genetically modified food and feed referred to in Article 28(1) of Regulation (EC)
No 1829/2003.
(12) This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on
Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2), point (c), of
Regulation (EC) No 1946/2003 of the European Parliament and of the Council(7).
(13) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid
down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it to the appeal
committee for further deliberation. The appeal committee did not deliver an opinion,
(4) Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique
identifiers for genetically modified organisms (OJ L 10, 16.1.2004, p. 5, ELI: http://data.europa.eu/eli/reg/2004/65/oj).
(5) Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and
labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified
organisms and amending Directive 2001/18/EC (OJ L 268, 18.10.2003, p. 24, ELI: http://data.europa.eu/eli/reg/2003/1830/oj).
(6) Commission Decision 2009/770/EC of 13 October 2009 establishing standard reporting formats for presenting the monitoring
results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing
on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council (OJ L 275, 21.10.2009, p. 9, ELI:
http://data.europa.eu/eli/dec/2009/770/oj).
(7) Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of
genetically modified organisms (OJ L 287, 5.11.2003, p. 1, ELI: http://data.europa.eu/eli/reg/2003/1946/oj).
2/6 ELI: http://data.europa.eu/eli/dec_impl/2025/699/ojEN
OJ L, 11.4.2025
HAS ADOPTED THIS DECISION:
Article 1
Genetically modified organism and unique identifier
Genetically modified maize (Zea mays L.) DP910521, as specified in point (b) of the Annex to this Decision, is assigned the
unique identifier DP-91Ø521-2, 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 maize DP-91Ø521-2;
(b) feed containing, consisting of or produced from genetically modified maize DP-91Ø521-2;
(c) products containing or consisting of genetically modified maize DP-91Ø521-2 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 ‘maize’.
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 maize DP-91Ø521-2 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 maize DP-91Ø521-2.
Article 5
Monitoring plan 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.
ELI: http://data.europa.eu/eli/dec_impl/2025/699/oj 3/6EN
OJ L, 11.4.2025
Article 6
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 7
Authorisation holder
The authorisation holder shall be Corteva Agriscience LLC, represented in the Union by Corteva Agriscience Belgium B.V.
Article 8
Validity
This Decision shall apply for a period of 10 years from the date of its notification.
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 B.V., rue Montoyer 25, 1000 Brussels, Belgium.
Done at Brussels, 9 April 2025.
For the Commission
Olivér VÁRHELYI
Member of the Commission
4/6 ELI: http://data.europa.eu/eli/dec_impl/2025/699/ojEN
OJ L, 11.4.2025
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., rue Montoyer 25, 1000 Brussels, Belgium.
(b) Designation and specification of the products:
(1) foods and food ingredients containing, consisting of or produced from genetically modified maize (Zea mays L.)
DP-91Ø521-2;
(2) feed containing, consisting of or produced from genetically modified maize (Zea mays L.) DP-91Ø521-2;
(3) products containing or consisting of genetically modified maize (Zea mays L.) DP-91Ø521-2 for uses other than
those provided for in points (1) and (2), with the exception of cultivation.
The genetically modified maize DP-91Ø521-2 expresses the mo-pat gene, which confers tolerance to herbicides
containing glufosinate-ammonium, the cry1B.34 gene, which confers protection against certain lepidopteran insect
pests, and the pmi gene, which was used as a selection marker in the genetic modification process.
(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
‘maize’.
(2) The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products
containing or consisting of genetically modified maize DP-91Ø521-2, with the exception of products referred
to in point (b)(1).
(d) Method for detection:
(1) event specific real-time PCR based method for the quantification of genetically modified maize DP-91Ø521-2;
(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: AOCS 0822-B (for DP-91Ø521-2) and AOCS 0822-A (for its non-GM counterpart), are
accessible via the American Oil Chemists Society (AOCS), at https://www.aocs.org/crm?SSO=True.
(e) Unique identifier:
DP-91Ø521-2
(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 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.
ELI: http://data.europa.eu/eli/dec_impl/2025/699/oj 5/6EN
OJ L, 11.4.2025
(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 requirements for the use of the food for human consumption:
Not required.
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.
6/6 ELI: http://data.europa.eu/eli/dec_impl/2025/699/oj