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Preliminary Considerations for ECHA's Guidance on the “Methodology To Preliminary considerations for ECHA’s guidance on the “Methodology to assess the risk to bees and other non-target arthropod pollinators from the use of biocides” Summary of consultation feedback December 2020 2 Preliminary considerations for ECHA’s guidance Disclaimer This publication is solely intended for information purposes and does not necessarily represent the official opinion of the European Chemicals Agency. The European Chemicals Agency is not responsible for the use that may be made of the information contained in this document. Version Changes Preliminary considerations for ECHA’s guidance on the “Methodology to assess the risk to bees and other non-target arthropod pollinators from the use of biocides” Reference: ECHA-20-H-24-EN ISBN: 978-92-9481-733-4 Cat. Number: ED-04-20-730-EN-N DOI: 10.2823/060407 Publ.date: December 2020 Language: EN © European Chemicals Agency, 2020 Cover page © European Chemicals Agency If you have questions or comments in relation to this document please send them (quote the reference and issue date) using the information request form. The information request form can be accessed via the Contact ECHA page at: http://echa.europa.eu/contact European Chemicals Agency P.O. Box 400, FI-00121 Helsinki, Finland Preliminary considerations for ECHA’s guidance 3 Table of Contents 1. INTRODUCTION ...................................................................................................... 4 1.1 Background and Terms of Reference (ToR) as provided by the requestor ....................... 4 1.2 Overview of ECHA’s Pollinator Expert Group approach ................................................. 5 1.3 Scope and structure of this document ....................................................................... 7 1.4 Collected feedback .................................................................................................. 7 2. SCOPING TOPICS .................................................................................................... 9 2.1 Exposure routes relevant to arthropod pollinators ...................................................... 11 2.1.1 Introduction.................................................................................................................... 11 2.1.2 Potential exposure of pollinators via first receiving compartments (i. e. due to releases) .......... 12 2.1.3 Potential exposure of pollinators via subsequent compartments ............................................ 17 2.1.3.1 Subsequent compartments following release to STP.............................................................. 17 2.1.3.2 Subsequent compartments after releases to soil and surface water ........................................ 18 2.1.3.3 Subsequent compartments after releases to air .................................................................... 18 2.1.3.4 Plants as a source of potential poisoning ............................................................................. 19 2.1.4 Exposure matrices relevant for pollinators due to biocides uses ............................................. 24 2.2 Biocidal active substances and products relevant for risk assessment of arthropod pollinators .......................................................................................................... 31 2.2.1 Universe of biocidal active substances ................................................................................ 31 2.2.2 Rapidly degrading, reacting and volatile substances ............................................................. 31 2.2.3 The process of translocation from roots to nectar, pollen and guttation water (systemicity) ...... 34 2.2.4 Grouping of active substances and mode of action (MoA) ..................................................... 36 2.3 Pollinators families and testing methods relevant for the risk assessment of arthropods pollinators .......................................................................................................... 40 2.3.1 Background .................................................................................................................... 40 2.3.2 Use of ecotox data performed with other insects or arthropods ............................................. 51 2.3.3 Available guidance from other organisations ....................................................................... 57 2.3.4 Testing methods and guidelines ........................................................................................ 58 2.3.5 Literature & Publications ................................................................................................... 62 ANNEX I. REFERENCE TO POLLINATORS IN CURRENT BIOCIDES GUIDANCE ............ 65 4 Preliminary considerations for ECHA’s guidance 1. Introduction 1.1 Background and Terms of Reference (ToR) as provided by the requestor On 2 December 2019, the European Commission mandated ECHA to develop a guidance for assessing the risks to arthropod pollinators (including bees) from biocides exposure to ensure a high and harmonised level of protection of the environment, taking into account EFSA’s Guidance Document on the Risk Assessment of Plant Protection Products on Bees (currently under review). In addition, ECHA was requested to specify the information required to enable a conclusion by the evaluating authority on whether products comply with the criteria under Article 19(1)(b)(iv) of the Biocidal Products Regulation concerning bees and other arthropod pollinators. According to the mandate, the following elements are to be considered by ECHA when addressing this question: - In order to develop a specific guidance to assess the risk to arthropod pollinators (including bees) from the use of biocides, ECHA shall use any information already available, and in particular the past and current work of EFSA in this field. - To ensure that all available information can be considered in the opinion a targeted consultation of stakeholders should occur. For this consultation, if ECHA considers it appropriate, an overview of biocidal active substances and biocidal products to which arthropod pollinators could be exposed and which may trigger directly or indirectly the occurrence of adverse effects in them could be prepared. - The current references to the assessment of risk to arthropod pollinators included in the ECHA Guidance on the Biocidal Products Regulation shall also be considered, along with the work in this field already carried out by the competent authorities and scientific bodies from the EU Member States. As a deadline for this work, the COM specified “ECHA shall inform DG SANTE on the outcome of this evaluation no later than 31 December 2021.” ECHA initiated during 2020 several actions to consider the elements included in the mandate: • In reference to the work being done at EFSA, ECHA and EFSA are in constant communication in relation to risk assessment to bees. Both agencies are regularly attending the meetings being held by ECHA or EFSA in regards to this topic and reviewing the available documentation. • In relation to the consultation of stakeholders, ECHA carried out a call for expression of interest to be part of the “Ad hoc ECHA Pollinators Guidance Stakeholder Consultation Group”. The role, composition and responsibility of the group and the criteria to select the representatives of the group was specified in the call. The group will be consulted two or three times during the guidance development. Preliminary considerations for ECHA’s guidance 5 1.2 Overview of ECHA’s Pollinator Expert Group approach The preparation of this guidance will be dealt with by in-house experts from ECHA together with experts from MSCAs by forming a dedicated expert group (i.e. ECHA´s Pollinators Expert Group). The work on the guidance started already in 2019 with the consolidation of the group and the group has met several times during 2020. As a first step, the group assessed the terms of reference (ToR) specified in the mandate from the Commission and decided to start with a scoping document before proceeding to the drafting phase. This is critically important in the guidance development for biocides as there is currently no specific guidance available to assess risk for arthropod pollinators. According to the ToRs, ECHA shall use any information already available, and in particular the past and current work of EFSA in this field. In this regard it is important to highlight that there are fundamental differences between plant protection products (PPP) and biocidal products that explains also why the approach to this guidance may differ in some aspects to the EFSA guidance. It also underlines why it is so important to discuss the scope before the drafting phase starts. On one hand, the type of application of biocides is fundamentally different to the type of application of PPP which leads to potentially different routes and levels of exposure of arthropod pollinators to active substances which may influence the focus of the guidance. Under biocides there are 22 different product types (as illustrated by Figure 1) and only a few of them can be compared to the type of use of PPP. The main uses of PPPs take place outdoors by direct application of the substance to plants or seeds in the field while in biocides most applications take place indoors and exposure to pollinators may only occur after the substance mobilizes through different compartments. As for outdoor uses of biocides, many are relatively limited in regard to spatial scale and/or are due to unintentional releases during application
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