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

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 maximum residue levels (MRLs) for that active substance. Among the active substances that need to be reviewed under Article 12(1) of Regulation (EC) No 396/2005, EFSA identified eight 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 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. In accordance with Article 12(1) of that Regulation, 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. 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 active substances that need to be reviewed under Article 12(1) of Regulation (EC) No 396/2005, EFSA identified eight active substances for which a review of MRLs is no longer considered necessary. EFSA therefore prepared a statement explaining the reasons why a review of MRLs became obsolete. The corresponding question numbers are considered addressed by this statement.

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

Introduction

Regulation (EC) No 396/20051 establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. In accordance with Article 12(1) of that Regulation, 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. 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 active substances that need to be reviewed under Article 12(1) of Regulation (EC) No 396/2005, EFSA identified eight active substances for which a review of MRLs is no longer considered necessary. EFSA therefore prepared a statement explaining the reasons why a review of MRLs is no longer considered necessary. The corresponding question numbers are considered addressed by this statement.

The draft statement was circulated to Member States for consultation via a written procedure. Comments received by 30 October 2017 were considered during the finalisation of this statement.

The collation of comments received on the draft statement is considered as background document to this statement and will be made publicly available.

Assessment

EFSA identified the following substances for which the dossier was submitted after entry into force of Regulation (EC) No 1107/20093 and thus the need for setting MRLs was considered in the EFSA conclusion. The European Commission proposed to amend the existing MRLs or set new MRLs on the basis of the EFSA conclusion. Therefore, the review of MRLs for the following substances becomes obsolete.

The non‐inclusion of the active substance tricyclazole in Annex I to Directive 91/414/EEC was provided for in Commission Decision 2008/770/EC.4 Following a new application in accordance with Article 7(1) of Regulation (EC) No 1107/2009, this active substance was not approved by Commission Implementing Regulation (EU) 2016/18265 on the basis of the EFSA conclusion (EFSA, 2015b). The MRLs for this substance are set at the limit of determination (LOD) by Commission Regulation (EU) 2017/9836 in accordance with Article 18 of Regulation (EC) No 396/2005. For the active substances for which all MRLs are reduced to the relevant LOD, default values are listed in Annex V in accordance with Article 18(1)(b) of Regulation (EC) No 396/2005. The Commission consulted the European Union reference laboratories as regards the need to adapt certain LODs. Those laboratories concluded that for certain commodities technical development permits the setting of lower LODs. Based on the information reported above, the review of MRLs for this substance becomes obsolete.

For the active substance halauxifen‐methyl, EFSA submitted a conclusion on the peer review of the pesticide risk assessment (EFSA, 2014e). In that framework, Commission Regulation (EU) 2016/677 sets MRLs for this active substance covering the representative uses according to good agricultural practices in the Union. Considering that there are no other uses authorised in the EU or import tolerances in place, the risk assessment performed in the EFSA conclusion is expected to cover all existing uses. Moreover, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limit (CXLs)) for this active substance. The Commission also consulted the European Union reference laboratories on the appropriate limits of determination. Therefore, the review of MRLs for this substance becomes obsolete.

For the active substance sulfoxaflor, EFSA submitted a conclusion on the peer review of the pesticide risk assessment (EFSA, 2014a). In that framework, Commission Regulation (EU) 2016/18 sets MRLs for this active substance covering both the representative uses according to Good Agricultural Practices (GAPs) in the Union and import tolerance requests from several third countries. Considering that there are no other uses authorised in EU or import tolerances in place, the risk assessment performed in the EFSA conclusion is expected to cover all existing uses. After the peer review, the existing CXLs were assessed by EFSA (2017) and legally implemented in the EU legislation by the Commission Regulation (EU) 2017/4059. The Commission consulted the European Union reference laboratories on the appropriate limits of determination. Therefore, the review of MRLs for this substance becomes obsolete.

For the active substance flumetralin, EFSA submitted a conclusion on the peer review of the pesticide risk assessment (EFSA, 2014d). In that framework, Commission Regulation (EU) 2016/48610 sets MRLs for this active substance covering the representative uses according to GAPs in the Union. Considering that there are no other uses authorised in EU or import tolerances in place, the risk assessment performed in the EFSA conclusion is expected to cover all existing uses. Moreover, no CXLs are established by the Codex Alimentarius Commission for this active substance. The Commission consulted the European Union reference laboratories on the appropriate limits of determination. Therefore, the review of MRLs for this substance becomes obsolete.

For the active substance 3‐decen‐2‐one, an application was submitted in accordance with Article 6(1) of Regulation (EC) No 396/2005 for the inclusion of that active substance in Annex IV to Regulation (EC) No 396/2005. The active substance was not approved in accordance with Regulation (EC) No 1107/2009 by Commission Decision 2008/770/EC4 on the basis of EFSA conclusion (EFSA, 2015a). It is therefore not appropriate to include the substance in Annex IV to Regulation (EC) No 396/2005 and the MRLs are set at the relevant LOD via Commission Regulation (EU) 2016/186611. The Commission consulted the European Union reference laboratories on the appropriate LODs. Therefore the review of MRLs for this substance becomes obsolete.

For the active substance cyantraniliprole, EFSA submitted a conclusion on the peer review of the pesticide risk assessment (EFSA, 2014c). Following the peer review, Commission Regulation (EU) 2017/17112 sets MRLs for this active substance covering the representative uses according to good agricultural practices in the Union and MRL applications for table grapes and various crops assessed by EFSA under Article 10 of Regulation 396/2005 (EFSA, 2015d, 2016a). The existing CXLs were also assessed by EFSA (2014b, 2015c, 2016b) and legally implemented in the EU legislation by the Commission Regulations (EU) 2015/84513 and 2017/62614. The Commission consulted the European Union reference laboratories on the appropriate limits of determination. Therefore, the review of MRLs for this substance becomes obsolete.

For the active substance methyl nonyl ketone, EFSA submitted a conclusion on the peer review of the pesticide risk assessment (EFSA, 2012). The approval of this active substance was withdrawn with the Commission Implementing Regulation (EU) 2017/78115. However, this substance was also provisionally included in Annex IV of Regulation (EC) No 396/2005 by Commission Regulation (EU) 839/2008, which means that no MRL are currently required. Moreover, neither import tolerances nor CXLs are currently in place for methyl nonyl ketone.

Quassia was not included in Annex I to Council Directive 91/414/EEC following voluntarily withdrawal. The MRLs have been set to the default MRL of 0.01 mg/kg according to Art 18(1)(b) Regulation (EC) No 396/2005. Therefore, the review of MRLs for this substance becomes obsolete.

Based on the above explanation, the following question numbers are considered addressed.

Conclusions

Among the active substances that need to be reviewed under Article 12 of Regulation (EC) No 396/2005, EFSA identified eight 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.

Other statements addressing additional active substances that do not require a review of MRLs (e.g. in view of inclusion in Annex IV of Regulation (EC) No 396/2005) may be issued by EFSA if needed.

Abbreviations

Codex Alimentarius Commission

Codex Committee on Pesticide Residues

codex maximum residue limit

European Union Reference Laboratories for Pesticide Residues (former CRLs)

Good Agricultural Practice

limit of determination

maximum residue level

Organisation for Economic Co‐operation and Development

rapporteur Member State

Question number (MRL review)	Active substance	RMS	Status under Reg (EU) No 1107/2009	Assessment made by EFSA	MRL Regulation
EFSA‐Q‐2009‐00021	Tricyclazole	IT	Not approved	EFSA (2015b)	Commission Regulation (EU) 2017/983
EFSA‐Q‐2015‐00476	Halauxifen‐methyl	UK	Approved	EFSA (2014e)	Commission Regulation (EU) 2016/67
EFSA‐Q‐2015‐00485	Sulfoxaflor	IE	Approved	EFSA (2014a, 2017)	Commission Regulation (EU) 2016/1, 2017/405
EFSA‐Q‐2015‐00740	Flumetralin	HU	Approved	EFSA (2014d)	Commission Regulation (EU) 2016/486
EFSA‐Q‐2016‐00116	3‐decen‐2‐one	NL	Not approved	EFSA (2015a)	Commission Regulation (EU) 2016/1866
EFSA‐Q‐2016‐00549	Cyantraniliprole	UK	Approved	EFSA (2014b,c, 2015c,d, 2016a,b)	Commission Regulation (EU) 2017/171, 2015/845, 2017/626
EFSA‐Q‐2009‐00094	Quassia	IT	Not approved	No peer review by EFSA	Regulation (EC) No 396/2005
EFSA‐Q‐2009‐00175	Methyl nonyl ketone	BE	Not approved	EFSA (2012)	Annex IV of Regulation (EC) No 396/2005

RMS: rapporteur Member State; MRL: maximum residue level.