Decisione UE In vigore

Decisione UE 2541/2025

Pubblicato: 16/12/2025 In vigore dal: 16/12/2025 Documento ufficiale

Cosa stabilisce la Decisione di esecuzione UE 2025/2541 sul rinnovo dell'autorizzazione del granturco geneticamente modificato MON 87427?

Spiegato da FiscoAI

La Decisione di esecuzione UE 2025/2541 rinnova per 10 anni l'autorizzazione all'immissione in commercio di prodotti contenenti, costituiti o derivati dal granturco geneticamente modificato MON 87427 (identificativo MON-87427-7). L'autorizzazione riguarda alimenti, mangimi e altri prodotti derivati da questo mais, ad eccezione della coltivazione, ed è stata rinnovata sulla base del parere scientifico favorevole dell'Autorità europea per la sicurezza alimentare (EFSA) del maggio 2025, che ha confermato l'assenza di nuovi rischi rispetto alla valutazione originaria del 2015. La decisione si applica ai produttori e distributori di alimenti e mangimi nell'Unione europea, in particolare a Bayer CropScience LP, titolare dell'autorizzazione, rappresentata in UE da Bayer Agriculture BV. In pratica, i prodotti contenenti questo mais modificato potranno circolare nel mercato europeo con l'obbligo di etichettatura specifica (indicazione "non per la coltivazione" su prodotti non alimentari) e il titolare dovrà presentare annualmente rapporti sull'implementazione del piano di monitoraggio degli effetti ambientali secondo i format stabiliti dalla Commissione.

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Riferimento normativo

Decisione di esecuzione (UE) 2025/2541 della Commissione, del 16 dicembre 2025, che rinnova l’autorizzazione all’immissione in commercio di prodotti contenenti, costituiti o derivati da granturco geneticamente modificato MON 87427 in conformità al regolamento (CE) n. 1829/2003 del Parlamento europeo e del Consiglio [notificata con il numero C(2025) 8558] EN: Commission Implementing Decision (EU) 2025/2541 of 16 December 2025 on renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize MON 87427 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2025) 8558)

Testo normativo

Official Journal
of the European Union
EN
L series
2025/2541
18.12.2025
COMMISSION IMPLEMENTING DECISION (EU) 2025/2541
of 16 December 2025
on renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize MON 87427 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
(notified under document C(2025) 8558)
(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 2003 on genetically modified food and feed
(
1
)
, and in particular to Article 11(3) and Article 23(3) thereof,
Whereas:
(1)
Commission Implementing Decision (EU) 2015/2281
(
2
)
authorised the placing on the market of food and feed containing, consisting of or produced from genetically modified maize MON 87427. The scope of that authorisation also covers the placing on the market of products, other than food and feed, containing or consisting of genetically modified maize MON 87427 for the same uses as any other maize, with the exception of cultivation.
(2)
On 19 March 2024, Bayer Agriculture B.V., based in Belgium, on behalf of Bayer CropScience LP, based in the United States of America (‘the applicant’), submitted an application to the Commission, in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003, for the renewal of that authorisation.
(3)
On 13 May 2025, the European Food Safety Authority (‘the Authority’) issued a favourable scientific opinion on genetically modified maize MON 87427
(
3
)
in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that the renewal application did not contain evidence of any new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on genetically modified maize MON 87427, issued by the Authority in 2015
(
4
)
.
(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 environmental effects, consisting of a general surveillance plan, submitted by the applicant, is in line with the intended uses of the products.
(6)
Taking into account those conclusions, the authorisation for the placing on the market of food and feed containing, consisting of or produced from genetically modified maize MON 87427 and of products containing or consisting of genetically modified maize MON 87427 for other uses than food or feed, with the exception of cultivation, should be renewed.
(7)
A unique identifier has been assigned to genetically modified maize MON 87427, in accordance with Commission Regulation (EC) No 65/2004
(
5
)
, in the context of its initial authorisation by Implementing Decision (EU) 2015/2281. That unique identifier should continue to be used.
(8)
As regards the products covered by this Decision, no specific labelling requirements, other than those provided for in Article 13(1) and Article 25(2), points (a) and (b), 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
(
6
)
, appear to be necessary. However, in order to ensure that the use of products containing or consisting of genetically modified maize MON 87427 remains within the limits of the authorisation granted by this Decision, the labelling of such products, 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
(
7
)
.
(10)
The opinion of the Authority does not justify the imposition of specific conditions or restrictions for the placing on the market, for the use and handling, including post-market monitoring requirements regarding the consumption of the food and feed containing, consisting of, or produced from genetically modified maize MON 87427, or for the protection of particular ecosystems/environment or geographical areas, as provided for in Article 6(5)(e) and Article 18(5)(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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council
(
8
)
.
(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,
HAS ADOPTED THIS DECISION:
Article 1
Genetically modified organism and unique identifier
Genetically modified maize (
Zea mays
L.) MON 87427, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-87427-7, in accordance with Regulation (EC) No 65/2004.
Article 2
Renewal of the authorisation
The authorisation for the placing on the market of the following products is renewed in accordance with the conditions set out in this Decision:
(a)
foods and food ingredients containing, consisting of or produced from genetically modified maize (
Zea mays
L.) MON-87427-7;
(b)
feed containing, consisting of or produced from genetically modified maize (
Zea mays
L.) MON-87427-7;
(c)
products containing or consisting of genetically modified maize (
Zea mays
L.) MON-87427-7 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), points (a) and (b), 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-87427-7, 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-87427-7.
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.
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, United States of America, represented in the Union by Bayer Agriculture B.V., Belgium.
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 OF AMERICA, represented in the Union by Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, BELGIUM.
Done at Brussels, 16 December 2025.
For the Commission
Olivér VÁRHELYI
Member of the Commission
(
1
)
OJ L 268, 18.10.2003, p. 1
, ELI:
http://data.europa.eu/eli/reg/2003/1829/oj
.
(
2
)
Commission Implementing Decision (EU) 2015/2281 of 4 December 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87427 (MON-87427-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (
OJ L 322, 8.12.2015, p. 67
, ELI:
http://data.europa.eu/eli/dec_impl/2015/2281/oj
).
(
3
)
EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2025. Assessment of genetically modified maize MON 87427 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2023-21254).
EFSA Journal
2025; 23 (5):9380.
https://doi.org/10.2903/j.efsa.2025.9380
.
(
4
)
EFSA GMO Panel, 2015. Scientific Opinion on the application (EFSA-GMO-BE-2012-110) for the placing on the market of tissue-selective herbicide-tolerant genetically modified maize MON 87427 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto.
EFSA Journal
, 13(6), 4130.
https://doi.org/10.2903/j.efsa.2015.4130
.
(
5
)
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
).
(
6
)
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
).
(
7
)
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
).
(
8
)
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
).
ANNEX
(a)
Applicant and authorisation holder:
Name
:
Bayer CropScience LP
Address
:
800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States of America
Represented in the Union by: Bayer Agriculture BV, 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-87427-7;
(2)
feed containing, consisting of or produced from genetically modified maize (
Zea mays
L.) MON-87427-7;
(3)
products containing or consisting of genetically modified maize (
Zea mays
L.) MON-87427-7 for uses other than those provided for in points (1) and (2), with the exception of cultivation.
The genetically modified maize MON-87427-7 expresses the CP4 EPSPS gene which confers tissue-selective tolerance to glyphosate herbicides. The CP4 EPSPS expression is absent or limited in male reproductive tissues, which eliminates or reduces the need for detasseling when MON-87427-7 is used as female parent in hybrid maize seed production.
(c)
Labelling:
(1)
For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2), points (a) and (b), 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 the genetically modified maize MON-87427-7, with the exception of products referred to in point (b)(1).
(d)
Method for detection:
(1)
event-specific real-time quantitative PCR methods validated for genetically modified maize MON-87427-7;
(2)
validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at
https://gmo-crl.jrc.ec.europa.eu/method-validations
(3)
reference material: AOCS 0512-A2 (for MON-87427-7) and AOCS 0406-A (for its non-GM counterpart) are accessible via the American Oil Chemists Society at
https://www.aocs.org/technical-products/certified-reference-materials-crms/
.
(e)
Unique identifier:
MON-87427-7
(f)
Information required pursuant to 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 of the European Parliament and of the Council
(
1
)
.
[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 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.
(
1
)
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
).
ELI: http://data.europa.eu/eli/dec_impl/2025/2541/oj
ISSN 1977-0677 (electronic edition)

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La Decisione UE 2025/2541 è il riferimento normativo per l'autorizzazione di organismi geneticamente modificati (OGM) nel settore alimentare e dei mangimi, disciplinata dal Regolamento (CE) 1829/2003. Operatori del settore agroalimentare, importatori e distributori devono conoscere i requisiti di etichettatura, tracciabilità e monitoraggio ambientale previsti dal Regolamento (CE) 1830/2003 e dalla Direttiva 2001/18/EC, nonché gli obblighi di registrazione nel registro comunitario degli OGM e di notifica al Protocollo di Cartagena sulla biosicurezza.