Date: 2025-04-11Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2025/694 of 9 April 2025 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 95275 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2025) 2115)
Issued by European Commission
· Directorate-General for Health and Food Safety
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**Report: Analysis of Commission Implementing Decision (EU) 2025/694 Regarding Genetically Modified Maize MON 95275**
**1. Executive Summary:**
This report analyzes Commission Implementing Decision (EU) 2025/694, which authorizes the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 95275 within the European Union. This decision follows a favorable scientific opinion from the European Food Safety Authority (EFSA) and establishes conditions for labeling, detection, and environmental monitoring. The authorization is valid for ten years and affects food, feed, and other product sectors, excluding cultivation.
**2. Introduction:**
This report aims to provide an informative overview of Commission Implementing Decision (EU) 2025/694 based solely on the provided text. The report details the policy's objectives, key provisions, affected stakeholders, implementation aspects, and expected outcomes.
**3. Policy Overview:**
* This is a *New Policy*.
* **Core Objective(s):** The primary objective, as inferred from the text, is to authorize the placing on the market of products derived from genetically modified maize MON 95275 within the EU, while ensuring safety for human and animal health and the environment, and providing for appropriate monitoring and labeling.
**4. Background and Rationale:**
* **New Policy:** The policy addresses the application by Bayer Agriculture B.V. for authorization to market products containing genetically modified maize MON 95275. The rationale stems from the need to regulate the introduction of genetically modified organisms (GMOs) into the food and feed supply chain and other product streams, balancing innovation with safety and consumer information, and to comply with Regulation (EC) No 1829/2003.
**5. Key Provisions / Changes:**
* **New Policy:** The decision establishes the following main provisions:
* **Authorization:** Authorizes the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from genetically modified maize MON 95275. It also allows the marketing of other products containing or consisting of the GM maize, *except* for cultivation.
* **Unique Identifier:** Assigns the unique identifier MON952757 to the genetically modified maize.
* **Labelling:** Specifies that products containing or consisting of the GM maize (except for food and food ingredients) must be labelled with "not for cultivation". Standard GMO labelling requirements under Regulations (EC) No 1829/2003 and 1830/2003 apply.
* **Detection Method:** Specifies a real-time PCR-based method for detecting the GM maize.
* **Monitoring Plan:** Requires the authorization holder to implement a monitoring plan for environmental effects and submit annual reports to the Commission.
* **Community Register:** Mandates the inclusion of relevant information in the Community register of genetically modified food and feed.
* **Authorization Holder:** Designates Bayer CropScience LP as the authorization holder, represented in the EU by Bayer Agriculture B.V.
* **Validity:** Sets the authorization validity period to 10 years.
**6. Target Audience and Stakeholders:**
The primary target audience and stakeholders are:
* **Bayer CropScience LP (and Bayer Agriculture B.V.):** As the authorization holder, they are directly responsible for complying with the decision's requirements (monitoring, reporting).
* **Food and Feed Industry:** Manufacturers, distributors, and retailers involved in the production and sale of food and feed products containing the GM maize.
* **Other Industries:** Those who use the maize for other non-cultivation purposes.
* **Consumers:** They are indirectly affected through the availability of products containing the GM maize and the associated labelling requirements.
* **EU Regulatory Bodies:** The European Commission and EFSA are involved in the oversight and implementation of the decision.
* **Member States Competent Authorities:** Responsible for enforcing the regulation.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:**
* European Commission: Responsible for overall implementation and oversight.
* Bayer CropScience LP: Responsible for implementing the monitoring plan and submitting reports.
* EU Reference Laboratory: Validates the detection method.
* **Timelines/Procedures:**
* The decision is effective from the date of its notification and is valid for 10 years.
* The authorization holder must submit annual reports on the monitoring plan.
* Information must be entered into the Community register.
**8. Expected Outcomes / Impact of Changes:**
* **New Policy:** The intended outcomes include:
* Legal and regulated access to the EU market for products containing genetically modified maize MON 95275.
* Compliance with EU regulations on GMOs.
* Ensured safety for human and animal health and the environment through risk assessment and monitoring.
* Transparency through labelling requirements.
* The introduction of this GMO maize could help to reduce the impact on crops by certain pests.
**9. Conclusion:**
Commission Implementing Decision (EU) 2025/694 authorizes the placing on the market of products containing genetically modified maize MON 95275, subject to specific conditions. It reflects the EU's regulatory framework for GMOs, aiming to balance innovation with safety and transparency. Bayer CropScience LP, as the authorization holder, has specific obligations regarding monitoring and reporting. The decision has implications for the food and feed industry, other industries, and consumers.
Key Entities Referenced
COMMISSION IMPLEMENTING DECISION EU 2025/694: Commission Implementing Decision of the European Union with the reference number 2025/694
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
European Commission: Executive branch of the European Union
Treaty on the Functioning of the European Union: Treaty defining the scope of the European Union
Bayer Agriculture B.V.: Company based in Belgium
Bayer CropScience LP: Company based in the United States
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: Agency of the European Union that provides independent scientific advice on food-related risks
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: EU committee involved in the decision-making process
Biosafety ClearingHouse: Mechanism established by the Cartagena Protocol on Biosafety to facilitate the exchange of information on living modified organisms
Cartagena Protocol on Biosafety to the Convention on Biological Diversity: International agreement on biosafety
MON 95275: Genetically modified maize
Community register of genetically modified food and feed: Register containing information on authorized genetically modified food and feed
MON952757: Unique identifier for the genetically modified organism MON 95275
American Oil Chemists Society AOCS: Organization providing reference materials.
Official Journal EN
of the European Union L series
2025/694 11.4.2025
COMMISSION IMPLEMENTING DECISION (EU) 2025/694
of 9 April 2025
authorising the placing on the market of products containing, consisting of or produced from
genetically modified maize MON 95275 pursuant to Regulation (EC) No 1829/2003 of the European
Parliament and of the Council
(notified under document C(2025) 2115)
(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 29 April 2022, Bayer Agriculture B.V., based in Belgium, on behalf of Bayer CropScience LP, 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
MON 95275, 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 95275 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 MON 95275 in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003(3).
The Authority concluded that genetically modified maize MON 95275, 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 95275 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 containing, consisting of
or produced from genetically modified maize MON 95275.
(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 MON 95275 (application GMFF-2022-5890). EFSA Journal 2024; 22(8):8886. https://doi.org/10.2903/j.efsa.2024.8886.
ELI: http://data.europa.eu/eli/dec_impl/2025/694/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 95275 should be authorised for the uses listed in the application.
(7) A unique identifier should be assigned to genetically modified maize MON 95275 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 95275, 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 MON 95275 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/2025/694/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 95275, as specified in point (b) of the Annex to this Decision, is assigned the
unique identifier MON-95275-7, 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-95275-7;
(b) feed containing, consisting of or produced from genetically modified maize MON-95275-7;
(c) products containing or consisting of genetically modified maize MON-95275-7 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-95275-7 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 MON-95275-7.
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/2025/694/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 Bayer CropScience LP, represented in the Union by Bayer Agriculture 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 Bayer CropScience LP, 800 N. Lindbergh Boulevard, St Louis, MO 63167, United States,
represented in the Union by Bayer Agriculture B.V., 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/2025/694/ojEN
OJ L, 11.4.2025
ANNEX
(a) Applicant and authorisation holder:
Name: Bayer CropScience LP
Address: 800 N. Lindbergh Boulevard, St Louis, MO, 63167, United States,
represented in the Union by Bayer Agriculture B.V., 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 (Zea mays L.)
MON-95275-7;
(2) feed containing, consisting of or produced from genetically modified maize (Zea mays L.) MON-95275-7;
(3) products containing or consisting of genetically modified maize (Zea mays L.) MON-95275-7 for uses other
than those provided for in points (1) and (2), with the exception of cultivation.
The genetically modified maize MON-95275-7 expresses the mpp75Aa1.1 and vpb4Da2 genes and the double-
stranded RNA DvSnf7, which confer protection against certain coleopteran insect pests.
(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 MON-95275-7, 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 MON-95275-7.
(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-A (for MON-95275-7) and AOCS 0406-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:
MON-95275-7
(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/2025/694/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/2025/694/oj