Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005

Abstract

Regulation (EC) No 396/2005 establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. According to Article 12(1) of Regulation (EC) No 396/2005, EFSA shall provide within 12 months from the date of the inclusion or non‐inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing MRLs for that active substance. Among the substances that need to be reviewed under Article 12(1) of Regulation (EC) No 396/2005, EFSA identified six active substances for which a review of MRLs is no longer considered necessary. EFSA prepared a statement explaining the reasons why a review of MRLs for these substances became obsolete. The relevant question numbers are considered addressed by this statement.

Summary

Regulation (EC) No 396/2005 establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. According to Article 12(1) of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) shall provide within 12 months from the date of the inclusion or non‐inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing MRLs for that active substance.

According to the legal provisions, EFSA shall base its reasoned opinion on the relevant assessment report prepared under Directive 91/414/EEC or Regulation (EC) No 1107/2009. The reasoned opinion should cover all pesticide residues data relevant to the risk assessment and MRL setting for a given active substance, including analytical methods and limit of determination (LOD) for enforcement of the proposed MRLs. All proposed MRLs should accommodate uses authorised within the European Union (EU), and uses authorised in third countries that have a significant impact on international trade. Among the substances that need to be reviewed under Article 12(1) of Regulation (EC) No 396/2005, EFSA identified six active substances for which a review of MRLs is no longer considered necessary.

EFSA prepared a statement explaining the reasons why a review of MRLs for these substances became obsolete. The corresponding question numbers are considered addressed by this statement. Furthermore, for five active substances, the existing uses were assessed in the framework of the renewal (combined assessment). The list of active substances for which the MRL review was addressed during the renewal from December 2021 (after the adoption of the previous statement) until the adoption of this statement, is also reported as an Annex to this statement.

The statement was circulated to Member States for consultation via a written procedure before finalisation.

1. Introduction

Regulation (EC) No 396/20051 establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. According to Article 12(1) of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) shall provide within 12 months from the date of the inclusion or non‐inclusion of an active substance in Annex I to Directive 91/414/EEC2 a reasoned opinion on the review of the existing MRLs for that active substance. According to the legal provisions, EFSA shall base its reasoned opinion on the relevant assessment report prepared under Directive 91/414/EEC or Regulation (EC) No 1107/20093. The reasoned opinion should cover all pesticide residues data relevant to the risk assessment and MRL setting for a given active substance, including analytical methods and limit of determination (LOD) for enforcement of the proposed MRLs. All proposed MRLs should accommodate uses authorised within the European Union (EU), and uses authorised in third countries that have a significant impact on international trade.

Among the substances that need to be reviewed under Article 12(1) of Regulation (EC) No 396/2005, EFSA identified six active substances for which a review of MRLs is no longer considered necessary. EFSA prepared a statement explaining the reasons why a review of MRLs for these substances became obsolete. Furthermore, for five active substances the existing uses were assessed in the framework of the renewal (combined assessment). The list of active substances for which the MRL review was addressed during the renewal from December 2021 (after the adoption of the previous statement) until the adoption of this statement, is also reported in Annex A to this statement.

The draft statement was circulated to Member States (MSs) for consultation via a written procedure. Comments received by 20 October 2022 were considered during the finalisation of this 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, 2022).

2. Assessment

The following substances have been assessed by EFSA in this statement.

The active substance chlorsulfuron was included in Annex I to Council Directive 91/414/EEC in accordance with Commission Decision 2009/77/EC4. An EFSA conclusion on the peer review for the pesticide risk assessment is available for this active substance (EFSA, 2009). No Codex maximum residue limits (CXLs) are established by the Codex Alimentarius Commission and no import tolerances are currently in place for chlorsulfuron. The approval of this active substance expired on 31 December 2019 and therefore chlorsulfuron is currently not any longer approved. A draft Regulation SANTE/10176/2022, lowering the MRLs for this active substance to the relevant limits of determination according to Art 18(1)(b) of Regulation (EC) No 396/2005, has been favourably voted by the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) in September 2022. Once the Regulation will be adopted (expected in early 2023), the review of MRLs for this substance will become obsolete.

The active substance epoxiconazole was initially included in Annex I to Council Directive 91/414/EEC in accordance with Commission Directive 2008/107/EC5. An EFSA conclusion on the peer review for the pesticide risk assessment is available for this active substance (EFSA, 2008). Confirmatory data were also assessed by EFSA (2015). No CXLs are established by the Codex Alimentarius Commission and no import tolerances are currently in place for epoxiconazole. The application for the renewal of the approval was withdrawn by the applicant and the approval of epoxiconazole expired on 30 April 2020; therefore, epoxiconazole is currently not any longer approved. The draft Regulation SANTE/10176/2022, lowering the MRLs for this active substance to the relevant limits of determination according to Art 18(1)(b) of Regulation (EC) No 396/2005 has been favourably voted by the SCoPAFF in September 2022. Once the Regulation will be adopted (expected in early 2023), the review of MRLs for this substance will become obsolete.

The active substance Metarhizium brunneum strain Ma 43 (formerly formerly Metarhizium anisopliae var. anisopliae strain BIPESCO 5/F52) was initially included in Annex I to Council Directive 91/414/EEC by Commission Directive 2008/113/EC6. Following the EFSA peer review of the pesticide risk assessment (EFSA, 2020), the approval of Metarhizium brunneum strain Ma 43 was renewed as a low‐risk active substance by Commission Implementing Regulation (EU) 2022/3837. The MRLs are currently set to the default MRL of 0.01 mg/kg according to Art 18(1)(b) of Regulation (EC) No 396/2005. In the light of this specific situation, the Commission and EFSA agreed that the substance would not need to undergo a full Article 12 review.

With regard to the five assessment criteria according to the Commission guidance SANCO/11188/2013 Rev. 2 (European Commission, 2015) for potential inclusion in Annex IV of Regulation (EC) No 396/2005, i.e. approval as basic substance (criterion I), listed in Annex I of Regulation (EC) No 396/2005 (criterion II), having no identified hazardous properties (criterion III), natural exposure is higher than the one linked to the use as plant protection product (criterion IV) and consumer exposure is not expected considering the representative uses (criterion V), not all the criteria were met for Metarhizium brunneum strain Ma 43 for the following reasons:

• Criteria I and II are not met.

• Criterion III is partially met. Metarhizium brunneum strain Ma 43 itself is not infective and not pathogenic and is not related to any known pathogens. However, the microorganism could produce non‐viable residues (metabolites) in plant matrices. The main metabolites produced by M. brunneum are destruxin A, B, D and E, cytochalasin C, D and E and swainsonine. Other metabolites were also identified in the literature review. With data from the available literature, showing negative results in supportive genotoxicity/cytotoxicity tests, no concern was raised; however, the full toxicological profile of destruxins and cytochalasins cannot be determined, no toxicological information has been identified for other possible metabolites, while swainsonine was identified as causal agent of food poisoning in livestock (grazing on plants contaminated by other fungi closely related to M. brunneum). It was reported that the consumption of this toxin containing plants leads to nervous signs and neurological alterations, also confirmed in mice and rat studies (EFSA, 2020).

• Criterion IV is inconclusive. No information on the levels of Metarhizium brunneum strain Ma 43 and its metabolites naturally occurring in food commodities is available in the renewal assessment report submitted in the framework of the peer review for the renewal.

• Criterion V is inconclusive. According to the representative uses, Metarhizium brunneum strain Ma 43 can be used by soil incorporation or by foliar spray on several edible crops. Based on the available evidence, for applications in the greenhouse and for uses in the root crop category, endophytic behaviour and therewith production of metabolites cannot be excluded (EFSA, 2020). Nevertheless, no information is available on the levels of parent and metabolites expected in food commodities from treated crops.

It should be noted that the data gaps and concerns identified in the EFSA conclusion for the metabolites were discussed by the Standing Committee on Plants, Animals, Food and Feed in view of the renewal of the approval of Metarhizium brunneum strain Ma 43 as a low‐risk substance in accordance with Regulation (EC) No 1107/2009. The Committee concluded that according to the available information the exposure and, consequently, the risk to humans or livestock arising from the production of metabolites upon field application can be considered negligible. Furthermore, the species M. brunneum is not known to be related to any human, animal, or plant pathogen, and it has been used as a biocontrol agent for over a decade without leading to any adverse effects on humans (European Commission, 2022a).

The active substance plants oil/citronella oil has been temporarily included in Annex IV of Regulation (EC) No 396/2005 by Commission Regulation (EC) No 839/20088. Plants oil/citronella oil has been approved by Commission Directive 2008/127/EC9. An EFSA conclusion on the peer review for the pesticide risk assessment is available for this active substance (EFSA, 2012). No CXLs are established by the Codex Alimentarius Commission for this active substance. The application for the renewal of the approval was withdrawn by the applicant and the approval of plants oil/citronella oil expired on 30 August 2022. In the light of this specific situation, the Commission and EFSA agreed that the substance would not need to undergo a full Article 12 review.

With regard to the five assessment criteria according to the Commission guidance SANCO/11188/2013 Rev. 2 (European Commission, 2015) for potential inclusion in Annex IV of Regulation (EC) No 396/2005, not all the criteria were met for plants oil/citronella oil for the following reasons:

• Criteria I and II are not met.

• Criterion III is inconclusive. Among the components of citronella oil, methyl eugenol and methyl isoeugenol are identified as toxicologically relevant impurities, being potential genotoxic carcinogens. However, during the peer review the experts agreed that the toxicological profile of citronella oil (with a composition compliant with the representative technical specification) cannot be concluded based on the available data (EFSA, 2012).

• Criterion IV is inconclusive. No information on the level of citronella oil naturally occurring in food commodities is available in the draft assessment report submitted in the framework of the peer review for the approval.

• Criterion V is partially met. The representative use supported for the approval of citronella oil was for spot spray treatment on common ragwort growing on grassland, green cover, amenity grassland and land temporarily removed from production. A quantitative consumer exposure assessment to the residues of citronella oil, its potential metabolites and the known relevant impurities (methyl eugenol and methyl isoeugenol) in animal commodities was considered not relevant since negligible contamination of the feed items was expected in view of the representative use. Nevertheless, a data gap was set to determine an appropriate withholding period before livestock can be allowed to re‐enter the treated areas, in order to minimise the exposure of livestock and taking into account that treated ragwort may become more palatable when dying off (EFSA, 2012).

The active substance straight chain Lepidopteran pheromones (SCLPs) was initially included in Annex I to Council Directive 91/414/EEC by Commission Directive 2008/127/EC ⁹ . Following the EFSA peer review of the pesticide risk assessment (EFSA, 2021), the approvals of SCLPs (acetates) as low‐risk active substances, and Straight chain Lepidopteran pheromones (aldehydes and alcohols) were renewed by Commission Implementing Regulation (EU) 2022/125110. The MRLs are currently set to the default MRL of 0.01 mg/kg according to Art 18(1)(b) of Regulation (EC) No 396/2005. In the light of this specific situation, the Commission and EFSA agreed that the substance would not need to undergo a full Article 12 review.

With regard to the five assessment criteria according to the Commission guidance SANCO/11188/2013 Rev. 2 (European Commission, 2015) for potential inclusion in Annex IV of Regulation (EC) No 396/2005, not all the criteria were met for SCLPs for the following reasons:

• Criteria I and II are not met.

• Criterion III is partially met. SCLPs covers several substances. The application for renewal of approval of SCLPs concerned 37 individual substances, which are alcohols (8), acetates (25) or aldehydes (4), and 11 blends consisting of different combinations of these single substances. Reduced data requirements for SCLPs have been proposed by the RMS and agreed by EFSA and the member state experts according to their non‐toxic and targeted mode of action, their typically low rates of application expected to result in a low human exposure and their low toxicological concern. However, this rationale is applicable when long‐term exposure above the background level can be excluded (OECD, 2001). Since according to the residue data, following spray applications, residues above the background could not be excluded for the alcohol (E,E)‐8,10‐dodecadien‐1‐ol and for its aldehyde and acid metabolites (see also criterion V), during the peer review further toxicological assessment was performed for these substances. Based on the data available, an ADI of 0.33 mg/kg bw per day was set only for (E,E)‐8,10‐dodecadien‐1‐ol while it was concluded that, in the absence of acute effects, an acute reference dose (ARfD) was not needed. For SCLPs that are aldehydes and acetates, it was concluded that reference values were not needed (EFSA, 2021).

• Criterion IV is partially met. SCLPs can be used by foliar spray application as microencapsulated active substance or via dispenser. Residues above the natural background levels are not expected for uses via dispensers. For uses with spray applications, if the capsules cannot remain intact during the treatment, an exposure higher compared to the natural background levels might be expected (EFSA, 2021).

• Criterion V is partially met. When the active substance is used via dispenser, no residues are expected in the edible crops. On the opposite, for uses with spray applications done until 1 day before harvest, residues above the limit of determination cannot be excluded in the edible crops. This conclusion is supported by the field trials on apples submitted in the framework of the peer review: in one out of the five trials performed with spray application (high and low volume) of (E,E)‐8,10‐dodecadien‐1‐ol and reflecting the Good Agricultural Practice (GAP) conditions for pome fruits, residues were above the limit of determination (0.02 mg/kg). Therefore, during the peer review a data gap was identified for three additional trials on apples compliant with the critical GAP conditions for spray application and analysing for (E,E)‐8,10‐dodecadien‐1‐ol (EFSA, 2021).

It should be noted that the data gaps identified in the EFSA conclusion were discussed by the Standing Committee on Plants, Animals, Food and Feed in view of the renewal of the approval of the active substances SCLPs (acetates) as low‐risk active substances and SLCPs (aldehydes and alcohols) in accordance with Regulation (EC) No 1107/2009. The Committee concluded that as SCLPs are characterised by high volatility and rapid dissipation in air, residues of SCLPs are expected to be negligible and below 0.01 mg/kg following application by spraying or via dispensers. Moreover, the Committee concluded that the study conducted with (E,E)‐8,10‐dodecadien‐1‐ol, which led to residues above the LOD in apples, was performed not in line with the GAP as the spray application was done in late autumn and the low temperatures might have led to the solidification of the substance which led to the findings of residues. Based on these considerations, they concluded that it is not expected that use in accordance with the GAP will lead to residues and that, therefore, no toxicological reference values need to be set for SCLPs (European Commission, 2022b).

The active substance topramezone (formerly BAS 670H) was assessed for a possible inclusion in Annex I to Directive 91/414/EEC. Commission Decision 2003/850/EC11 recognised in principle the completeness of the dossier submitted by the applicant. An EFSA conclusion on the peer review for the pesticide risk assessment is available for this active substance (EFSA, 2014). On 29 June 2020, the applicant withdrew the application for approval of topramezone. Consequently, topramezone was not approved by Commission Implementing Regulation (EU) 2021/7912. The draft regulation SANTE/10088/2022, lowering the MRLs for this active substance to the relevant limits of determination has been favourably voted by the SCoPAFF in September 2022. Once the Regulation will be adopted (expected in early 2023), the review of MRLs for this substance will become obsolete.

Based on the above explanation, the following question numbers are considered addressed (Table 1).

Table 1.

List of active substances that do not require MRL review

No	Question number (MRL review)	Active substance	RMS	Status under Reg (EC) No 1107/2009	Assessment made by EFSA	MRL Regulation
1.	EFSA‐Q‐2010‐00182	Chlorsulfuron	PL	Not approved	EFSA (2009)	Draft Regulation SANTE/10176/2022 Relevant limits of determination (LOD) according to Art 18(1)(b) Reg 396/2005
2.	EFSA‐Q‐2009‐00127	Epoxiconazole	PL	Not approved	EFSA (2008, 2015)	Draft Regulation SANTE/10176/2022 Relevant limits of determination (LOD) according to Art 18(1)(b) Reg 396/2005
3.	EFSA‐ Q‐2009‐00131	Metarhizium brunneum strain Ma 43	NL	Approved	EFSA (2020)	Default MRL of 0.01 mg/kg according to Art 18(1)(b) Reg 396/2005
4.	EFSA‐Q‐2009‐00177	Plant oils/Citronella oil	FR	Not approved	EFSA (2012)	Reg. (EC) No 839/2008 Temporarily included in Annex IV
5.	EFSA‐Q‐2009‐00007	Straight chain Lepidopteran pheromones	IT	Approved	EFSA (2021)	Default MRL of 0.01 mg/kg according to Art 18(1)(b) Reg 396/2005
6.	EFSA‐ Q‐2020‐00754	Topramezone	FR	Not approved	EFSA (2014)	Draft Regulation SANTE/10176/2022 Relevant limits of determination (LOD) according to Art 18(1)(b) Reg 396/2005

3. Conclusions

Among the active substances that need to be reviewed under Article 12 of Regulation (EC) No 396/2005, EFSA identified six active substances for which a review of MRLs is not needed. EFSA therefore prepared a statement explaining the reasons why a review of MRLs is no longer necessary for these active substances. The corresponding question numbers are considered addressed by this statement.

Abbreviations

ADI

acceptable daily intake

ARfD

acute reference dose

CXL

codex maximum residue limit

DAR

draft assessment report

GAP

Good Agricultural Practice

LOD

limit of determination

MRL

maximum residue level

MS

Member States

PRIMo

(EFSA) Pesticide Residues Intake Model

RMS

rapporteur Member State

SANCO

Directorate‐General for Health and Consumers

SCoPAFF

Standing Committee on Plants, Animals, Food and Feed

Annex A – Active substances for which the Article 12 review was addressed in the framework of the peer review for the renewal

Question number	Active substance	RMS	Adoption date
EFSA‐Q‐2009‐00184	Fish oil	CZ	15/12/2021	https://www.efsa.europa.eu/it/efsajournal/pub/7079
EFSA‐Q‐2009‐00185	Sheep fat	CZ	15/12/2021	https://www.efsa.europa.eu/it/efsajournal/pub/7073
EFSA‐Q‐2009‐00179	Rape seed oil	NL	30/3/2022	https://www.efsa.europa.eu/it/efsajournal/pub/7305
EFSA‐Q‐2017‐00451	Quartz sand	LV	10/8/2022	https://www.efsa.europa.eu/en/efsajournal/pub/7552
EFSA‐Q‐2017‐00130	Aluminium silicate (aka kaolin)	EL	14/10/2022	https://www.efsa.europa.eu/en/efsajournal/pub/7637

Suggested citation: EFSA (European Food Safety Authority) , 2023. Statement on pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2023;21(2):7723, 11 pp. 10.2903/j.efsa.2023.7723