Commission Implementing Regulation (EU) 2026/321 of 12 February 2026 amending Implementing Regulations (EU) 2017/1506 and (EU) No 540/2011 as regards the conditions of approval of the active substance maleic hydrazide
Date: 2026-02-12
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: market approval, plant health control, plant health product








L_202600321EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2026/321


13.2.2026







            COMMISSION IMPLEMENTING REGULATION (EU) 2026/321
of 12 February 2026
         
amending Implementing Regulations (EU) 2017/1506 and (EU) No 540/2011 as regards the conditions of approval of the active substance maleic hydrazide
(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 13(2) thereof,

Whereas:







(1)


Commission Implementing Regulation (EU) 2017/1506 (2) renewed the approval of the active substance maleic hydrazide subject to the condition that Member States ensure that the label of the treated crops includes the indication that the crops were treated with maleic hydrazide, and the accompanying instructions to avoid exposure of livestock. This implied that maleic hydrazide cannot be used on crops that are fed to animals.












(2)


On 30 March 2021, Belgium received an application pursuant to Article 7(1) of Regulation (EC) No 1107/2009 from the ‘Maleic Hydrazide Task Force’ for the amendment of the conditions of approval of maleic hydrazide by removing the above-mentioned condition to allow for the use of maleic hydrazide on crops intended to be fed to livestock.












(3)


In accordance with Article 9(3) of Regulation (EC) No 1107/2009, on 26 March 2021, Belgium, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) of the admissibility of the application.












(4)


The rapporteur Member State assessed the information provided by the applicant and submitted a draft renewal assessment report to the Authority and the Commission on 12 October 2021. In its draft renewal assessment report, the rapporteur Member State proposed to amend the conditions of approval of maleic hydrazide by removing the above-mentioned condition to allow for the use of maleic hydrazide on crops intended to be fed to livestock.












(5)


The Authority circulated the draft assessment report received from the rapporteur Member State to the applicant and the other Member States. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested the applicant to supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the form of an updated draft renewal assessment report in March 2024.












(6)


In July 2025, the Authority sent to the applicant, the Member States and the Commission its conclusion (3) on the peer review of the pesticide risk assessment of the active substance maleic hydrazide. The Authority concluded that all the representative uses of plant protection products containing maleic hydrazide assessed, including the use on crops intended to be fed to livestock, can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. Based on the new toxicological data submitted in the application for the amendment of the conditions of approval, the Authority concluded that the concern previously identified, that led to the restriction being set in Implementing Regulation (EU) 2017/1506, had been addressed, and concluded that metabolite 3-pyridazinone is not genotoxic and proposed an acceptable daily intake for this metabolite.












(7)


The Commission presented an addendum to the renewal report of maleic hydrazide to the Standing Committee on Plants, Animals, Food and Feed on 1 October 2025 and a draft of this Regulation regarding the amendment of the conditions of the approval of maleic hydrazide on 10 December 2025.












(8)


The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 13(1) of Regulation (EC) No 1107/2009, on the addendum to the renewal report. The applicant submitted its comments, which were taken into due consideration.












(9)


The Commission therefore considers that the concern that led to the restriction set in Implementing Regulation (EU) 2017/1506 has been addressed and that the outcome of the risk assessment is favourable to an amendment of the conditions of approval to remove the existing restriction to not use maleic hydrazide on crops intended to be fed to livestock.












(10)


It is therefore appropriate to amend the conditions of approval of maleic hydrazide to remove the current condition that Member States are to ensure, where appropriate, that the label of the treated crops includes the indication that the crops were treated with maleic hydrazide, and the accompanying instructions to avoid exposure of livestock.












(11)


Implementing Regulation (EU) 2017/1506 and, in accordance with Article 13(4) of Regulation (EC) No 1107/2009, Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.












(12)


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

Amendment to Implementing Regulation (EU) 2017/1506

Annex I to Implementing Regulation (EU) 2017/1506 is amended in accordance with Annex I to this Regulation.


Article 2

Amendment 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

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 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) 2017/1506 of 28 August 2017 renewing the approval of the active substance maleic hydrazide 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 222, 29.8.2017, p. 21, ELI: http://data.europa.eu/eli/reg_impl/2017/1506/oj).

(3)  Conclusion on pesticides peer review of the pesticide risk assessment of the active substance maleic hydrazide; EFSA Journal 2025;23:e9522. Available online: https://doi.org/10.2903/j.efsa.2025.9522.




ANNEX I
Annex I to Implementing Regulation (EU) 2017/1506 is replaced by the following:



‘ANNEX I










Common Name, Identification Numbers


IUPAC Name


Purity (1)



Date of approval


Expiration of approval


Specific provisions




Maleic hydrazide
CAS No 123-33-1
CIPAC No 310


6-hydroxy-2H-pyridazin-3-one


≥ 979 g/kg
The impurity hydrazine shall not exceed 0,028 mg/kg in the technical material.


1 November 2017


31 October 2032


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 on maleic hydrazide, and in particular Appendices I and II thereto, as well as its addendum, shall be taken into account.
In this overall assessment Member States shall pay particular attention to:






—


the protection of consumers;










—


the operator and worker safety; the conditions of the use shall include the application of adequate personal protective equipment.




Conditions of use shall include risk mitigation measures, where appropriate.






            ’
         


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





ANNEX II
Row 117, maleic hydrazide, in Part B of the Annex to Implementing Regulation (EU) No 540/2011 is replaced by the following:












No


Common Name, Identification Numbers


IUPAC Name


Purity (1)



Date of approval


Expiration of approval


Specific provisions




‘117


Maleic hydrazide
CAS No 123-33-1
CIPAC No 310


6-hydroxy-2H-pyridazin-3-one


≥ 979 g/kg
The impurity hydrazine shall not exceed 0,028 mg/kg in the technical material.


1 November 2017


31 October 2032


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 on maleic hydrazide, and in particular Appendices I and II thereto, as well as its addendum, shall be taken into account.
In this overall assessment Member States shall pay particular attention to:






—


the protection of consumers;










—


the operator and worker safety; the conditions of the use shall include the application of adequate personal protective equipment.




Conditions of use shall include risk mitigation measures, where appropriate.’







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



ELI: http://data.europa.eu/eli/reg_impl/2026/321/oj
ISSN 1977-0677 (electronic edition)