Commission Implementing Regulation (EU) 2026/312 of 10 February 2026 renewing the approval of the active substance maltodextrin as a low-risk active substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011
Date: 2026-02-10
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: market approval, plant health control, plant health product








L_202600312EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2026/312


11.2.2026







            COMMISSION IMPLEMENTING REGULATION (EU) 2026/312
of 10 February 2026
         
renewing the approval of the active substance maltodextrin as a low-risk active substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011
(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 1107/2009, of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) in conjunction with Article 22(1) thereof,

Whereas:







(1)


Commission Implementing Regulation (EU) No 355/2013 (2) included maltodextrin as an active substance in Annex I to Council Directive 91/414/EEC (3).












(2)


Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).












(3)


The approval of the active substance maltodextrin, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 28 February 2027.












(4)


An application for the renewal of the approval of the active substance maltodextrin was submitted to Ireland, the rapporteur Member State, and France, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) and within the time period provided for in that Article.












(5)


The applicant submitted the supplementary dossier required to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be admissible by the rapporteur Member State.












(6)


The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 11 November 2022. In its draft renewal assessment report, the rapporteur Member State proposed to renew the approval of maltodextrin.












(7)


The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.












(8)


On 18 February 2025, the Authority communicated to the Commission its conclusion (6) indicating that plant protection products containing maltodextrin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.












(9)


On 9 July 2025, the Commission presented a renewal report to the Standing Committee on Plants, Animals, Food and Feed and on 2 October 2025 a draft of this Regulation.












(10)


The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined and taken into consideration.












(11)


It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance maltodextrin that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.












(12)


The Commission further considers that maltodextrin is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Maltodextrin is not a substance of concern and fulfils the conditions set in point 5 in Annex II to Regulation (EC) No 1107/2009.












(13)


It is therefore appropriate to renew the approval of maltodextrin pursuant to Article 22 of Regulation (EC) No 1107/2009 as a low-risk active substance.












(14)


In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge and the outcome of the risk assessment, it is, however, necessary to set a minimum purity of the active substance as manufactured, in order to ensure the safety of the active substance to be used in plant protection products.












(15)


Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.












(16)


Commission Implementing Regulation (EU) 2025/2316 (7) extended the approval period of maltodextrin to 28 February 2027 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply earlier than that date.












(17)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,





HAS ADOPTED THIS REGULATION:



Article 1

Renewal of the approval of the active substance

The approval of the active substance maltodextrin, as specified in Annex I to this Regulation, is renewed, subject to the conditions laid down in that Annex.


Article 2

Amendments to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.


Article 3

Entry into force and date of application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 April 2026.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 February 2026.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj.

(2)  Commission Implementing Regulation (EU) No 355/2013 of 18 April 2013 approving the active substance maltodextrin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 109, 19.4.2013, p. 14, ELI: http://data.europa.eu/eli/reg_impl/2013/355/oj).

(3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1, ELI: http://data.europa.eu/eli/dir/1991/414/oj).

(4)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2011/540/oj).

(5)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26, ELI: http://data.europa.eu/eli/reg_impl/2012/844/oj).

(6)  Conclusion on pesticides peer review of the pesticide risk assessment of the active substance maltodextrin; EFSA Journal 2025; 23:e9294. Available online: https://doi.org/10.2903/j.efsa.2025.9294.

(7)  Commission Implementing Regulation (EU) 2025/2316 of 17 November 2025 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances aluminium silicate, difenoconazole, diflufenican, disodium phosphonate, extract from tea tree, flurochloridone, indolylbutyric acid, maltodextrin, phosphane, plant oils/clove oil, plant oils/spear mint oil, potassium phosphonates and triclopyr (OJ L, 2025/2316, 18.11.2025, ELI: http://data.europa.eu/eli/reg_impl/2025/2316/oj).




ANNEX I










Common Name, Identification Numbers


IUPAC Name


Purity (1)



Date of approval


Expiration of approval


Specific provisions




Maltodextrin
CAS No: 9050-36-6
CIPAC No: 801


None allocated


≥ 853 g/kg maltodextrin with chain lengths 3 – 20 monomer units; with dextrose equivalence (DE) 18-20.


3 March 2026


3 March 2041


For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report of maltodextrin dated 11 December 2025 and in particular Appendices I and II thereto, shall be taken into account.
In this overall assessment Member States shall pay particular attention to the protection of honeybees.
Conditions of use shall include risk mitigation measures, where appropriate.






(1)  Further details on the identity and specification of the active substance are provided in the renewal report.





ANNEX II
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:






(1)


in Part B, entry 44 on maltodextrin is deleted;










(2)


in Part D, the following entry is added:











No


Common Name, Identification Numbers


IUPAC Name


Purity (1)



Date of approval


Expiration of approval


Specific provisions




‘57


Maltodextrin
CAS No: 9050-36-6
CIPAC No: 801


None allocated


≥ 853 g/kg maltodextrin with chain lengths 3 – 20 monomer units; with dextrose equivalence (DE) 18-20.


3 March 2026


3 March 2041


For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report of maltodextrin dated 11 December 2025 and in particular Appendices I and II thereto, shall be taken into account.
In this overall assessment Member States shall pay particular attention to the protection of honeybees.
Conditions of use shall include risk mitigation measures, where appropriate.’










(1)  Further details on the identity and specification of the active substance are provided in the renewal report.



ELI: http://data.europa.eu/eli/reg_impl/2026/312/oj
ISSN 1977-0677 (electronic edition)