Lack of confirmatory data following Article 12 MRL reviews for dicloran, fenazaquin and tebufenozide

Abstract

In accordance with Article 31 of Regulation (EC) No 178/2002, the European Commission mandated EFSA to issue a statement concerning confirmatory data that were not submitted by the set deadline by the applicant following Article 12 MRL reviews under Regulation (EC) No 396/2005 for the active substances dicloran, fenazaquin and tebufenozide. EFSA assessed the availability and completeness of the confirmatory information and prepared a statement providing a conclusion on whether the existing tentative maximum residue levels (MRLs) are supported by data. The statement also included indications to risk managers whether the tentative MRLs currently established by Regulation (EC) No 396/2005 could be maintained. Before finalisation, the statement was circulated to Member States for consultation via a written procedure.

1. BACKGROUND AND TERMS OF REFERENCE

During the review of maximum residue levels (MRLs) for pesticide active substances in accordance with Article 12 of Regulation (EC) No 396/2005 ¹ (“the Regulation”), EFSA may identify data gaps for certain commodity/crop combinations. If no risk to consumers is identified, EFSA can propose tentative MRLs pending submission of further information to address the data gaps identified. These data gaps are subsequently indicated in specific footnotes in Annex II of the Regulation with indication on the date by which the applicant is required to submit the missing information (i.e. confirmatory data) to EFSA in support of the proposed MRL.

There are two possible main outcomes of this process:

1. the applicant submits such information by the deadline indicated in the footnotes set in Annex II of the Regulation. In this case, the Commission mandates EFSA as part of the monthly mandate for MRL applications to prepare and publish a reasoned opinion on the outcome of the evaluation of the confirmatory data, confirming the tentative MRL in case this data is sufficient to address the data gap, or otherwise identifying the need for further consideration by risk managers and/or suggesting lowering of the tentative MRL to the Limit of Quantification (LOQ) of the analytical method and/or proposing a fall back MRL.

2. the applicant does not submit such information by the deadline indicated in Annex II of the Regulation. In this case, the Commission mandates EFSA to provide a scientific statement to support the Commission's risk management action where no data was submitted by the applicant by the deadline indicated in the footnotes set in Annex II of the Regulation.

In January 2026, in accordance with Article 31 of Regulation (EC) No 178/2002, ² the European Commission mandated EFSA to issue a statement concerning confirmatory data that were not submitted by the applicant within the set deadline, following the Article 12 MRL review. The request concerned the following substances/commodity combinations: dicloran on onions; fenazaquin on citrus fruits, pome fruits, strawberries, tomatoes and teas; tebufenozide on cherries, rice, swine liver, kidney and edible offals, bovine liver, kidney and edible offals, sheep fat, liver, kidney and edible offals, goat fat, liver, kidney and edible offals, equine liver, kidney and edible offals, poultry muscle, fat, liver, kidney, edible offals, milk and bird eggs.

EFSA was asked:

• to confirm the lack of the confirmatory data required and draw a conclusion on the completeness of the data necessary to support the existing MRLs;

• to give an indication to risk managers whether the tentative MRLs currently established by Regulation (EC) No 396/2005 can be maintained or not.

The Commission also requested EFSA to share the draft statement for Member States' consultation prior to finalisation.

In February 2026, EFSA assessed the availability and completeness of the confirmatory information and prepared a statement providing a conclusion on whether the existing tentative MRLs are supported by data and giving indications to risk managers whether the tentative MRLs currently established by Regulation (EC) No 396/2005 could be maintained.

Before finalisation, the draft statement was circulated to Member States (MSs) for consultation via a written procedure. Comments received by 02 March 2026 were considered during the finalisation of the statement.

The collation of comments received on the draft statement is considered as a background document to this statement and is made publicly available (EFSA, 2026).

2. ASSESSMENT

2.1. Dicloran

In 2013, when reviewing the existing MRLs for dicloran in line with Article 12 of Regulation (EC) No 396/2005, EFSA identified some information as unavailable (data gaps) and derived tentative MRLs for the use on onions which was not fully supported by data despite no risk to consumers was identified (EFSA, 2013). In particular, the following data gap was noted by EFSA and implemented in the MRL legislation by Commission Regulation (EU) No 1126/2014 ³ :

1. Residue trials on onions considering metabolite 4‐amino‐3,5‐dichlorophenol (DCHA)

The regulation indicated that confirmatory data should be provided by 24 October 2016 by a party having an interest in maintaining the proposed tentative MRL.

Following consultation with Member States through a written procedure, it is confirmed that no confirmatory data have been submitted within the established deadline. Furthermore, it is noted that the existing tentative MRL set during the Art 12 Review was originally established on the basis of a Codex MRLs (CXL) that was revoked in 2021 (CAC, 2021). Therefore, the currently established MRL on onions is not supported by data.

2.2. Fenazaquin

In 2020, when reviewing the existing MRLs for fenazaquin in line with Article 12 of Regulation (EC) No 396/2005, EFSA identified some information as unavailable (data gaps) and derived tentative MRLs for those uses which were not fully supported by data despite no risk to consumers was identified (EFSA, 2020). In particular, the following data gaps were noted by EFSA and implemented in the MRL legislation by Commission Regulation (EU) No 2021/1110 ⁴ :

1. Residue trials supporting the import tolerance uses on citrus fruits, pome fruits, strawberries and tomatoes.

2. A validated analytical method for the detection of fenazaquin in tea and additional residue trials analysing for TBPE in tea.

The regulation indicated that confirmatory data should be provided by 7 July 2023 by a party having an interest in maintaining the proposed tentative MRLs.

For what concerns citrus fruits, following consultation with Member States through a written procedure, it is confirmed that no confirmatory data have been submitted within the established deadline. Nevertheless, it is noted that an MRL application for new import tolerances has been submitted in 2024 to the Evaluating Member State (EMS) Greece (EFSA‐Q‐2024‐00503). ⁵ The application is currently at intake phase.

For what concerns pome fruits, following consultation with Member States through a written procedure, it is confirmed that no confirmatory data have been submitted within the established deadline. Therefore, the currently established MRL on pome fruits is not supported by data. It is also noted that a Codex MRL exists for apples but cannot be proposed for implementation in EU legislation as a reservation was raised by the EU delegation (CAC, 2023).

For what concerns strawberries, following consultation with Member States through a written procedure, it is confirmed that no confirmatory data has been submitted to support the most critical Good Agricultural Practice (GAP) assessed during the MRL review. Therefore, the currently established MRL on strawberries is not supported by data. Nevertheless, a lower MRL was derived under an MRL application recently assessed by EFSA (EFSA, 2025a).

For tomatoes, following consultation with Member States through a written procedure, it is confirmed that no confirmatory data has been submitted to support the most critical GAP assessed during the MRL review. Therefore, the currently established MRL on tomatoes is not supported by data. However, a higher MRL was derived under an MRL application recently assessed by EFSA (EFSA, 2025a, 2025b).

It is noted that the higher MRL derived by EFSA was included in the draft Regulation voted at the ScoPAFF meeting held on 24–25 November 2025 (PLAN/2025/2567 Rev.1). However, at the time of drafting this statement, the Regulation is not yet applicable.

For tea, it is noted that an MRL application on requested confirmatory data was submitted in 2024 to the EMS Germany (EFSA‐Q‐2024‐00422). ⁶ The application is currently at intake phase.

2.3. Tebufenozide

In 2018, when reviewing the existing MRLs for tebufenozide according to Article 12 of Regulation (EC) No 396/2005, EFSA identified some information as unavailable (data gaps) and derived tentative MRLs for those uses which were not fully supported by data despite no risk to consumers was identified (EFSA, 2018). In particular, the following data gaps were noted by EFSA and implemented in the MRL legislation by Commission Regulation (EU) No 2019/973 ⁷ :

1. Five additional trials on cherries (sweet) compliant with the northern outdoor GAP;

2. Eight trials on rice compliant with the southern outdoor GAP and analysed according to the residue definition for enforcement and risk assessment separately;

3. Confirmatory analytical methods for animal matrices.

The regulation indicated that confirmatory data should be provided by 14 June 2021 by a party having an interest in maintaining the proposed tentative MRLs.

For cherries, following consultation with Member States through a written procedure, it is confirmed that no confirmatory data to support the existing tentative MRL on cherries were submitted by the applicant by the established legal deadline. Therefore, the currently established MRL on cherries is not supported by data. It is noted that the existing MRL for this commodity is already set at the LOQ.

For rice and the commodities of animal origin, following consultation with Member States through a written procedure, it is confirmed that no confirmatory data to support the existing tentative MRLs were provided. However, for these commodities, CXL were adopted by the Codex Alimentarius Commission in 2025. It is noted that no reservations were raised by the EU delegation (CAC, 2025; EFSA, 2025b).

3. CONCLUSIONS AND RECOMMENDATIONS

EFSA assessed the availability of the confirmatory data and confirmed that for all the active substances/commodity combinations applicants did not submit confirmatory data by the given deadline. Accordingly, EFSA provided indications to risk managers on whether the existing tentative MRLs could be maintained, lowered to the limit of quantification, or replaced by alternative MRLs, including recently adopted Codex MRLs, where applicable (see details in Table 1 below). ⁸ , ⁹ , ¹⁰

TABLE 1.

Summary table.

Code number	Commodity	Existing EU MRL (mg/kg)	Existing CXL (mg/kg)	Outcome
				MRL (mg/kg)	Comment
Dicloran
220020	Onions	0.2	–	LOQ	No confirmatory data were submitted. Existing tentative MRL not supported by data. Risk managers can consider lowering the MRL to the LOQ.
Fenazaquin
110000	Citrus fruit	0.3	0.4 a for oranges 0.3 a for all other citrus fruits	0.3	No confirmatory data were submitted. Reservation was raised by EU on the CXLs. MRL application is on‐going. Risk managers can consider maintaining existing MRL and footnote pending the outcome of the MRL application.
130000	Pome fruits	0.159	0.3 a for apples	LOQ	No confirmatory data were submitted. Existing tentative MRL is not supported by data and reservation was raised by EU on the CXL. Risk Managers can consider lowering to the LOQ.
152000	Strawberries	0.49	–	0.3	No confirmatory data were submitted. A lower MRL was derived by EFSA under an MRL application. Risk managers can consider deleting footnote and set MRL at recently derived lower value.
231010	Tomatoes	0.059	0.3 a	0.2	No confirmatory data were submitted. A higher MRL was derived by EFSA following an MRL application and included for legal implementation in the draft Regulation PLAN/2025/2567 Rev.1, but not yet applicable. Reservation was raised by EU on the CXL. Risk managers can consider deleting footnote and set MRL at recently derived higher value.
610000	Teas	99	–	9	No confirmatory data were submitted. MRL application is on‐going. Risk managers can consider maintaining existing MRL and footnote pending the outcome of the MRL application.
Tebufenozide
140020	Cherries (sweet)	0.01*	–	0.01*	No confirmatory data submitted. Tentative MRL not supported by data. Risk Managers can consider maintaining the existing MRL as already set at the LOQ.
500060	Rice	310	0.6	0.6	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1011030	Swine Liver	0.0510	0.06	0.06	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1011040	Swine Kidney	0.02* 10	0.06	0.06	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1011050	Swine Edible offals (other than liver and kidney)	0.0510	0.06	0.06	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1012030	Bovine Liver	0.0510	0.06	0.06	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1012040	Bovine Kidney	0.02* 10	0.06	0.06	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1012050	Bovine Edible offals (other than liver and kidney)	0.0510	0.06	0.06	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1013020	Sheep fat	0.0510	0.2	0.2	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1013030	Sheep Liver	0.0510	0.06	0.06	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1013040	Sheep Kidney	0.02* 10	0.06	0.06	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1013050	Sheep Edible offals (other than liver and kidney)	0.0510	0.06	0.06	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1014020	Goat fat	0.0510	0.2	0.2	No confirmatory data were submitted. Risk managers can consider the newly adopted CXs for MRL setting.
1014030	Goat Liver	0.0510	0.06	0.06	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1014040	Goat Kidney	0.02* 10	0.06	0.06	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1014050	Goat Edible offals (other than liver and kidney)	0.0510	0.06	0.06	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1015030	Equine Liver	0.0510	0.06	0.06	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1015040	Equine Kidney	0.02* 10	0.06	0.06	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1015050	Equine Edible offals (other than liver and kidney)	0.0510	0.06	0.06	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1016010	Poultry Muscle	0.02* 10	0.02*	0.02*	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1016020	Poultry Fat	0.02* 10	0.02	0.02	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1016030	Poultry Liver	0.02* 10	0.02*	0.02*	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1016040	Poultry Kidney	0.02* 10	0.02*	0.02*	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1016050	Poultry Edible offals (other than liver and kidney)	0.02* 10	0.02*	0.02*	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1020000	Milk	0.01* 10	0.02	0.02	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.
1030000	Birds eggs	0.02* 10	0.02	0.02	No confirmatory data were submitted. Risk managers can consider the newly adopted CXL for MRL setting.

Abbreviations: CXL, Codex MRLs; LOQ, limit of quantification; MRL, maximum residue level.

^*Indicates that the MRL is set at the limit of quantification.

^a Reservations were raised by EU delegation on the advancement of these CXLs (CAC, 2023). Therefore, they were not proposed for implementation in the EU Legislation.

ABBREVIATIONS

DCHA

4‐amino‐3,5‐dichlorophenol

EMS

Evaluating Member State

GAP

Good Agricultural Practice

LOQ

limit of quantification

MRL

maximum residue level

MS

Member States

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2026‐00041

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EFSA (European Food Safety Authority) , (2026). Lack of confirmatory data following Article 12 MRL reviews for dicloran, fenazaquin and tebufenozide. EFSA Journal, 24(4), e10064. 10.2903/j.efsa.2026.10064