Date: 2025-04-11Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2025/692 of 9 April 2025 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 94804 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2025) 2116)
Issued by European Commission
· Directorate-General for Health and Food Safety
## Policy Analysis Report: Commission Implementing Decision (EU) 2025/692 Regarding Genetically Modified Maize MON 94804
**1. Executive Summary:**
This report analyzes Commission Implementing Decision (EU) 2025/692, which authorizes the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 94804 within the European Union. This is a new policy. The decision follows a favorable scientific opinion from the European Food Safety Authority (EFSA). Key findings include the authorization of the specified GM maize for food, feed, and other non-cultivation uses, subject to specific labeling requirements and a monitoring plan for environmental effects. The authorization is valid for 10 years.
**2. Introduction:**
This report provides an overview and analysis of Commission Implementing Decision (EU) 2025/692 based solely on the text provided. The purpose is to inform affected industry stakeholders about the scope, provisions, and implications of this decision regarding the use of genetically modified maize MON 94804.
**3. Policy Overview:**
* **Core Objective(s):** The core objective is to authorize the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 94804 for specific uses within the EU, subject to defined conditions and regulations. This authorization is based on EFSA's assessment of safety for human and animal health and the environment.
**4. Background and Rationale:**
* **New Policy:** This implementing decision addresses the application by Bayer Agriculture BV for authorization to place GM maize MON 94804 on the market. The policy addresses the need for a regulatory framework to govern the introduction and use of genetically modified organisms in the food and feed chain, ensuring safety and compliance with EU regulations. The underlying problem the policy addresses is how to regulate the placing of genetically modified Maize on the market.
**5. Key Provisions / Changes:**
* The decision authorizes the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from genetically modified maize MON 94804.
* It also authorizes products containing or consisting of this GM maize for uses other than food and feed, *excluding cultivation*.
* The GM maize is assigned the unique identifier MON94844.
* The name of the organism for labeling purposes shall be maize.
* Products containing or consisting of the GM maize, *except* for foods and food ingredients, must be labelled with the words "not for cultivation."
* A specific real-time PCR-based method for the detection of the GM maize is mandated. The method is validated by the EU reference laboratory.
* The authorisation holder is required to implement a monitoring plan for environmental effects.
* The authorisation holder must submit annual reports to the Commission regarding the monitoring plan.
* All relevant information will be entered into the Community register of genetically modified food and feed.
* The authorisation is valid for 10 years from the date of notification.
**6. Target Audience and Stakeholders:**
Based on the provided text, the primary target audience and stakeholders include:
* Bayer CropScience LP (and its representative Bayer Agriculture BV), the authorization holder.
* Food and feed producers and distributors who intend to use or sell products containing, consisting of, or produced from genetically modified maize MON 94804.
* Consumers who may be exposed to products containing this GM maize.
* The European Food Safety Authority (EFSA).
* EU member state authorities responsible for enforcement of food and feed safety regulations.
**7. Implementation Aspects (Inferred):**
* **Responsible agency/bodies:** The European Commission is ultimately responsible for implementing the decision. EFSA provides the scientific basis for the decision. Member States are responsible for enforcement within their jurisdictions. The authorization holder, Bayer, is responsible for adhering to the monitoring and reporting requirements.
* **Timelines or procedures:** The decision is effective for 10 years from the date of notification. The authorization holder must submit annual reports on the environmental monitoring plan.
**8. Expected Outcomes / Impact of Changes:**
* The intended outcome is to allow the controlled and regulated use of GM maize MON 94804 within the EU, subject to safety assessments and monitoring.
* The "not for cultivation" labeling requirement aims to prevent unintended cultivation of the GM maize outside of authorized trials or contained environments.
* The monitoring plan seeks to ensure there are no unforeseen adverse environmental effects.
* Adherence to detection method allows the verification of the presence of the GM maize.
**9. Conclusion:**
Commission Implementing Decision (EU) 2025/692 authorizes the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 94804 for a period of 10 years, under specific conditions and regulations. The decision is significant for food and feed producers, distributors, and consumers, as it allows for the use of this GM maize within the EU market. The decision includes measures for labelling and environmental monitoring to mitigate potential risks and ensure compliance. The authorized uses EXCLUDE cultivation.
Key Entities Referenced
COMMISSION IMPLEMENTING DECISION EU 2025/692: Commission Implementing Decision authorising the placing on the market of products containing genetically modified maize MON 94804.
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: Refers to the Council of the European Union.
Article 7(3): Article related to the Regulation EC No 1829/2003.
Article 19(3): Article related to the Regulation EC No 1829/2003.
Treaty on the Functioning of the European Union: Treaty that forms the constitutional basis of the European Union.
Bayer Agriculture BV: Company based in Belgium.
Bayer CropScience LP: Company based in the United States.
Netherlands: Country where the application was submitted.
Article 5: Article related to the Regulation EC No 1829/2003.
Article 17: Article related to the Regulation EC No 1829/2003.
maize MON 94804: Genetically modified maize.
Article 5(5): Article related to the Regulation EC No 1829/2003.
Article 17(5): Article related to the Regulation EC No 1829/2003.
Annex II: Annex to Directive 2001/18/EC.
Directive 2001/18/EC: Directive of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms.
Annexes III: Annex to Directive 2001/18/EC.
Annex IV: Annex to Directive 2001/18/EC.
Annex VII: Annex to Directive 2001/18/EC.
Article 28(1): Article related to the Regulation EC No 1829/2003.
Article 9(1): Article related to the Regulation EC No 1946/2003.
Article 15(2): Article related to the Regulation EC No 1946/2003.
European Food Safety Authority: Authority that issued a scientific opinion on the genetically modified maize MON 94804.
Article 6: Article related to the Regulation EC No 1829/2003.
Article 18: Article related to the Regulation EC No 1829/2003.
Article 6(4): Article related to the Regulation EC No 1829/2003.
Article 18(4): Article related to the Regulation EC No 1829/2003.
Article 6(5): Article related to the Regulation EC No 1829/2003.
Article 18(5): Article related to the Regulation EC No 1829/2003.
Commission Regulation EC No 65/2004: Commission Regulation establishing a system for the development and assignment of unique identifiers for genetically modified organisms.
Article 13(1): Article related to the Regulation EC No 1829/2003.
Article 25(2): Article related to the Regulation EC No 1829/2003.
Article 46: Article related to the Regulation EC No 1830/2003.
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.
Article 6(5), point e: Article related to the Regulation EC No 1829/2003.
Article 18(5), point e: Article related to the Regulation EC No 1829/2003.
Regulation EC No 1946/2003: Regulation of the European Parliament and of the Council on transboundary movements of genetically modified organisms.
Cartagena Protocol on Biosafety to the Convention on Biological Diversity: International agreement on biosafety.
Standing Committee on Plants, Animals, Food and Feed: Committee involved in the decision-making process.
appeal committee: Committee for further deliberation.
MON94844: Unique identifier assigned to genetically modified maize Zea mays L. MON 94804.
Article 4(2): Article related to the Regulation EC No 1829/2003.
Article 16(2): Article related to the Regulation EC No 1829/2003.
Article 13(1): Article related to the Regulation EC No 1830/2003.
Bayer CropScience LP: Authorisation holder.
Community register of genetically modified food and feed: Register for information on genetically modified food and feed
Official Journal EN
of the European Union L series
2025/692 11.4.2025
COMMISSION IMPLEMENTING DECISION (EU) 2025/692
of 9 April 2025
authorising the placing on the market of products containing, consisting of or produced from
genetically modified maize MON 94804 pursuant to Regulation (EC) No 1829/2003 of the European
Parliament and of the Council
(notified under document C(2025) 2116)
(Only the Dutch text is 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 14 February 2023, Bayer Agriculture BV, based in Belgium, submitted on behalf of Bayer CropScience LP, based
in the United States, 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
MON 94804, 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 MON 94804 for uses other than food and feed, with the exception of cultivation.
(2) In accordance with 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 26 April 2024, the European Food Safety Authority (‘the Authority’) issued a favourable scientific opinion on the
genetically modified maize MON 94804 in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003(3).
The Authority concluded that genetically modified maize MON 94804, 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 MON 94804 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 assessment of genetically modified
maize MON 94804 for food and feed uses, under Regulation (EC) No 1829/2003 (application GMFF-2022-10651). EFSA Journal
2024; 22(4): 8714, 20 pp. https://doi.org/10.2903/j.efsa.2024.8714.
ELI: http://data.europa.eu/eli/dec_impl/2025/692/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 MON 94804 should be authorised for the uses listed in the application.
(7) A unique identifier should be assigned to genetically modified maize MON 94804 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 MON 94804, 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 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/2025/692/ojEN
OJ L, 11.4.2025
HAS ADOPTED THIS DECISION:
Article 1
Genetically modified organism and unique identifier
Genetically modified maize (Zea mays L.) MON 94804, as specified in point (b) of the Annex to this Decision, is assigned the
unique identifier MON-948Ø4-4, 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 maize MON-948Ø4-4;
(b) feed containing, consisting of or produced from genetically modified maize MON-948Ø4-4;
(c) products containing or consisting of genetically modified maize MON-948Ø4-4 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 ‘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 MON-948Ø4-4 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 MON-948Ø4-4.
Article 5
Monitoring plan for environmental effects
1. The authorisation holder shall ensure that the monitoring plan for environmental effects 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/2025/692/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
referred to in Article 28(1) of Regulation (EC) No 1829/2003.
Article 7
Authorisation holder
The authorisation holder shall be Bayer CropScience LP, represented in the Union by Bayer Agriculture BV.
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 Bayer CropScience LP, 800 N. Lindbergh Boulevard St. Louis, Missouri 63167, United States,
represented in the Union by Bayer Agriculture BV, Haven 627, Scheldelaan 460, 2040 Antwerp, 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/2025/692/ojEN
OJ L, 11.4.2025
ANNEX
(a) Applicant and authorisation holder:
Name: Bayer CropScience LP
Address: 800 N. Lindbergh Boulevard St. Louis, Missouri 63167, United States,
represented in the Union by Bayer Agriculture BV, Haven 627, Scheldelaan 460, 2040 Antwerp, Belgium.
(b) Designation and specification of the products:
(1) foods and food ingredients containing, consisting of or produced from genetically modified maize as referred to
in point (e);
(2) feed containing, consisting of or produced from genetically modified maize as referred to in point (e);
(3) products containing or consisting of genetically modified maize as referred to in point (e), for uses other than
those provided for in points (1) and (2), with the exception of cultivation.
The genetically modified maize MON-948Ø4-4 expresses the GA20ox_SUP microRNA (miRNA), which leads to a
reduction in the overall plant height.
(c) Labelling:
(1) For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) 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 the genetically modified maize referred to in point (e), with the exception of the
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 MON-948Ø4-4.
(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: AOCS 1221-B is accessible via the American Oil Chemists Society at https://www.aocs.
org/crm.
(e) Unique identifier:
MON-948Ø4-4
(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]
ELI: http://data.europa.eu/eli/dec_impl/2025/692/oj 5/6EN
OJ L, 11.4.2025
(i) Post-market monitoring requirements for the use of the food for human consumption:
Not required.
Note: links to the 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/2025/692/oj