Summary

Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659, lays down the procedure for the renewal of the approval of active substances submitted under Article 14 of Regulation (EC) No 1107/2009. The list of those substances is established in Commission Implementing Regulation (EU) No 686/2012 as amended by Commission Implementing Regulation (EU) No 2016/183. Abamectin is one of the active substances listed in that Regulation.

In accordance with Article 1 of Regulation (EU) No 844/2012, the rapporteur Member State (RMS), Austria, and co-rapporteur Member State (co-RMS), Malta, received an application from the Abamectin Task Force comprising Industrias Afrasa, S.A., Lainco, S.A., Probelte S.A.U., Rotam Agrochem International Co Ltd and SAPEC Agro, S.A. for the renewal of approval of the active substance abamectin.

An initial evaluation of the dossier on abamectin was provided by the RMS in the renewal assessment report (RAR) and subsequently, a peer review of the pesticide risk assessment on the RMS evaluation was conducted by EFSA in accordance with Article 13 of Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659.

The European Food Safety Authority (EFSA) published its conclusion on the peer review of the pesticide risk assessment of abamectin on 20 August 2020. On 1 February 2022, the European Commission sent a mandate to EFSA with a request to review the exposure and risk assessments as regards birds and mammals, aquatic organisms and soil macroorganisms. The risk assessment to bees and non-target arthropods was also updated.

The uses of abamectin according to the representative uses as an insecticide and acaricide on tomato and strawberry in permanent greenhouses and walk-in tunnels, as proposed at the European Union (EU) level result in a sufficient insecticidal and acaricidal efficacy against the target organisms.

The assessment of the data package revealed no issues that need to be included as critical areas of concern with respect to the identity, physical, chemical and technical properties of abamectin or the respective formulation.

In the area of mammalian toxicology and non-dietary exposure, no critical areas of concern were identified.

The assessment of the data package revealed no issues that could not be finalised or that need to be included as critical areas of concern with respect to residues in food and feed for the representative uses in southern Europe (SEU), besides the fact that consumer risk assessment cannot be finalised due to the data gap identified in the Fate section with respect of drinking water. Consumer risk assessment cannot be finalised for the representative uses in northern Europe (NEU) since a data gap has been identified for residue trials performed under these conditions. The maximum residue level (MRL) proposed in Article 12 of Regulation (EC) No 396/2005 (EFSA, 2014b) will need to be revised as for change of toxicological reference values (acceptable daily intake (ADI) and acute reference dose (ARfD)), since it is envisaged that acute risk may be identified for some of the crops.

The data available on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at EU level, with the notable exception that a data gap was identified for information on the effect of water treatment processes on the nature of residues of both the active substance and its identified metabolites potentially present in surface water, when surface water is abstracted for the production of drinking water. This gap leads to the consumer risk assessment from the consumption of drinking water being not finalised for all the representative uses.

Based on the available information, abamectin does not meet the ED criteria for both humans and non-target organisms.

Background

Commission Implementing Regulation (EU) No 844/20121, as amended by Commission Implementing Regulation (EU) No 2018/16592, (hereinafter referred to as ‘the Regulation’), lays down the provisions for the procedure of the renewal of the approval of active substances, submitted under Article 14 of Regulation (EC) No 1107/20093. This regulates for the European Food Safety Authority (EFSA) the procedure for organising the consultation of Member States, the applicant(s) and the public on the initial evaluation provided by the rapporteur Member State (RMS) and/or co-rapporteur Member State (co-RMS) in the renewal assessment report (RAR), and the organisation of an expert consultation where appropriate.

In accordance with Article 13 of the Regulation, unless formally informed by the European Commission that a conclusion is not necessary, EFSA is required to adopt a conclusion on whether the active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 within 5 months from the end of the period provided for the submission of written comments, subject to an extension of an additional 3 months where additional information is required to be submitted by the applicant(s) in accordance with Article 13(3). Furthermore, in accordance with Article 13(3a), where the information available in the dossier is not sufficient to conclude the assessment on whether the approval criteria for endocrine disruption are met, additional information can be requested to be submitted in a period of minimum 3 months, not exceeding 30 months, depending on the type of information requested.

In accordance with Article 1 of the Regulation, the RMS Austria and co-RMS Malta received an application from the Abamectin Task Force comprising Industrias Afrasa, S.A., Lainco, S.A., Probelte S.A.U., Rotam Agrochem International Co Ltd and SAPEC Agro, S.A. for the renewal of approval of the active substance abamectin. Complying with Article 8 of the Regulation, the RMS checked the completeness of the dossier and informed the applicants, the co-RMS (Malta), the European Commission and EFSA about the admissibility.

The RMS provided its initial evaluation of the dossier on abamectin in the RAR, which was received by EFSA on 17 April 2019 (Austria, 2019).

In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and the applicants, the Abamectin Task Force comprising Industrias Afrasa, S.A., Lainco, S.A., Probelte S.A.U., Rotam Agrochem International Co Ltd and SAPEC Agro, S.A., for consultation and comments on 29 May 2019. EFSA also provided comments. In addition, EFSA conducted a public consultation on the RAR. EFSA collated and forwarded all comments received to the European Commission on 29 July 2019. At the same time, the collated comments were forwarded to the RMS for compilation and evaluation in the format of reporting table. In addition, the applicants were invited to respond to the comments received. The comments and the applicants’ response were evaluated by the RMS in column 3.

The need for expert consultation and the necessity for additional information to be submitted by the applicants in accordance with Article 13(3) of the Regulation were considered in a telephone conference between EFSA, the RMS and co-RMS on 11 October 2019. On the basis of the comments received, the applicants’ response to the comments and the RMS’s evaluation thereof, it was concluded that additional information should be requested from the applicants, and that EFSA should conduct an expert consultation in the areas of mammalian toxicology, residues, environmental fate and behaviour and ecotoxicology.

The outcome of the telephone conference, together with EFSA’s further consideration of the comments, is reflected in the conclusions set out in column 4 of the reporting table. All points that were identified as unresolved at the end of the comment evaluation phase and which required further consideration, including those issues to be considered in an expert consultation, were compiled by EFSA in the format of an evaluation table.

The conclusions arising from the consideration by EFSA, and as appropriate by the RMS, of the points identified in the evaluation table, together with the outcome of the expert consultation and the written consultation on the assessment of additional information, where these took place, were reported in the final column of the evaluation table.

A final consultation on the conclusions arising from the peer review of the risk assessment took place with Member States via a written procedure in June 2020.

EFSA published its conclusion on the peer review of the pesticide risk assessment of abamectin on 20 August 2020 (EFSA, 2020a) in which, inter alia, a critical area of concern was identified regarding the chronic risk to aquatic invertebrates from abamectin for all the uses in permanent greenhouses and in walk-in tunnels. In addition, a high risk was identified for walk-in tunnels uses for birds and mammals, aquatic invertebrates (for the metabolite 8-carboxy-6-hydroxy avermectin B_1a in permanent greenhouses as well), honeybees, non-target arthropods, earthworms and other soil macroorganisms.

EFSA was requested to update its conclusion as the results of this mandate within five months from receiving the updated RAR and LoEP from the RMS, which were received by EFSA on 28 February 2022 (Austria, 2022). On 13 May 2022, the RMS submitted a new version of the updated RAR and LoEP including also new calculations of the lower application rate for bees and non-target arthropods, in agreement with Commission, as were missing from the mandate while a high risk in walk-in tunnels was identified in the previous conclusion (Austria, 2022).

This conclusion report summarises the outcome of the peer review of the risk assessment of the active substance and the representative formulation, evaluated on the basis of the representative uses of abamectin as an insecticide and acaricide on tomato and strawberry, as proposed by the applicants, and updated following the request from Commission to review the exposure and risk assessments as regards birds and mammals, aquatic organisms and soil macroorganisms. The updated conclusions of the risk assessment as regards bees and non-target arthropods are also reported. In accordance with Article 12(2) of Regulation (EC) No 1107/2009, risk mitigation options identified in the RAR and considered during the peer review are presented in the conclusion.

A list of the relevant end points for the active substance and the formulation is provided in Appendix 18.

Given the importance of the RAR, including its revisions (Austria, 2020, 2022), and the peer review report, both documents are considered as background documents to this conclusion and thus are made publicly available.

It is recommended that this conclusion and its background documents would not be accepted to support any registration outside the EU for which the applicant has not demonstrated that it has regulatory access to the information on which this conclusion report is based.

The active substance and the formulated product

Abamectin is the ISO common name for mixture of ≥ 80% avermectin B_1a: (10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.1^4,8.0^20,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-l-arabino-hexopyranosyl)-3-O-methyl-α-l-arabino-hexopyranoside and ≤ 20% avermectin B_1b: (10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.1^4,8.0^20,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-l-arabino-hexopyranosyl)-3-O-methyl-α-l-arabino-hexopyranoside (IUPAC).

The representative formulated product for the evaluation was ‘Abamectin 1.8% EC’, an emulsifiable concentrate (EC) containing 18 g/L abamectin.

The representative uses evaluated were spray applications as an insecticide and acaricide against dipteran leafminers and mites in permanent greenhouses and walk-in tunnels (that are closed at the time the application is made) with soil bound growing systems of tomato and strawberry. Full details of the Good Agricultural Practices (GAPs) can be found in the list of end points in Appendix 18.

Data were submitted to conclude that the uses of abamectin according to the representative uses proposed at EU level result in a sufficient efficacy against the target organisms, following the guidance document SANCO/2012/11251-rev. 4 (European Commission, 2014b).

A data gap has been identified for a search of the scientific peer-reviewed open literature on the active substance and its relevant metabolites, dealing with side effects on health and published within the 10 years before the date of submission of the dossier, to be conducted and reported in accordance with EFSA guidance on the submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009 (EFSA, 2011).