This draft has not been adopted or endorsed by the European Commission. Any views expressed are the preliminary views of the Commission services and may not in any circumstances be regarded as stating an official position of the Commission. The information transmitted is intended only for the Member State or entity to which it is addressed for discussions and may contain confidential and/or privileged material. EN EN Commission Notice of XXX Step wise implementation of the EFSA Guidance Document on the Risk Assessment of Plant Protection Products on Bees (Apis mellifera, Bombus spp. and solitary bees) On 27 June 2013, the European Food Safety Authority adopted a Guidance Document on the Risk Assessment of Plant Protection Products on Bees (Apis mellifera, Bombus spp. and solitary bees)1 and re-published on 4 July 2014 (hereinafter, the 'EFSA Guidance Document'). This document provides Member States (MS) and applicants with guidance on how to assess the risks to honey bees, bumble bees and solitary bees from exposure to pesticides. In December 2013, a workshop of risk managers and risk assessors from MS concluded that the EFSA Guidance Document could not be used fully and immediately, because not all the scientific methodology was yet ready to be applicable in each area of the risk assessment. A step-wise implementation of the EFSA Guidance Document was proposed. After further consultation with the Standing Committee on Plants, Animals, Food and Feed and aiming at a harmonised and efficient implementation, the Commission notifies that the published EFSA Guidance Document on the Risk Assessment of Plant Protection Products on Bees (Apis mellifera, Bombus spp. and solitary bees) is to be implemented as follows: 1) The chapters of the EFSA Guidance Document listed in Part A should be used for the assessment of applications for the approval or renewal of approval of active substances and for the assessment of applications for an authorisation or a renewal of authorisation of plant protection products for which a dossier is submitted after 30 June 2019 . 2) The chapters of the EFSA Guidance Document listed in Part B should be used for the assessment of applications for the approval or renewal of approval of active substances and for the assessment of applications for an authorisation or a renewal of authorisation of plant protection products for which a dossier is submitted according to the different deadlines included in the table. 3) Part C lists further actions proposed in order to allow for full implementation of the EFSA Guidance Document. 1 European Food Safety Authority, 2013. EFSA Guidance Document on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees). EFSA Journal 2013;11(7):3295, 268 pp., doi:10.2903/j.efsa.2013.3295 Available online: www.efsa.europa.eu/efsajournal. 2 Part A Parts of the EFSA guidance document to be used for applications submitted after 30 31 June December 2019 HONEYBEES Screening step spray applications Trigger value Guideline/test protocol Acute contact adults HQ > 42 (downwards spray); OECD Test Guideline 214 Chapter 3.2.1 HQ > 85 (upwards/sideways) Table 2 Acute oral adults ETR > 0.2 OECD Test Guideline 213 Chapter 3.2.2 Table 3 Exposure from surface water ETRacute adults > 0.2; Use highest PECsw from Chapter 3.5.2 FOCUS step 1 or RAC for aquatic organisms. Exposure from puddle water ETRacute adults > 0.2; Use run-off PEC values from FOCUS Exposure to plant metabolites Reference to the EFSA Guidance Document of 4 July 2014 Chapter 3.5.3 Chapter 3.6 Screening step solid formulations Trigger value Guideline/test protocol Acute contact adults HQ >14 OECD Test Guideline 214 Chapter 3.3.1 fdep from Table H1b Acute oral adults ETR > 0.2 OECD Test Guideline 213 Chapter 3.3.2 Table 7 3 Reference to the EFSA Guidance Document of 4 July 2014 Exposure from surface water ETRacute adults > 0.2; Use highest PECsw from FOCUS step 1 or RAC for aquatic organisms. Exposure from puddle water ETRacute adults > 0.2; Use run-off PEC values Chapter 3.5.3 from FOCUS Exposure to plant metabolites Chapter 3.5.2 Chapter 3.6 Refined risk assessment for exposure via nectar and pollen following spray applications Trigger value Guideline/test protocol Reference to the EFSA Guidance Document of 4 July 2014 Refined exposure estimates ETRacute > 0.2 OECD Test Guideline 213 Chapter 3.2.2 Ef-values from tables X1a and X2a as appropriate for the relevant scenario ETRacute; for all relevant scenarios SV-values from Tables Jx and Jy as appropriate for the relevant scenario Consider risk mitigation measures Chapter 9 Appendix S Consider further refinement of exposure estimate 4 Semi-field and field effects studies Based on EPPO 2010 and Chapter 6.1.2 OECD 2007 with further and Appendix details as provided in O Appendix O Refined risk assessment for contact exposure following spray application Trigger value Guideline/test protocol Refined exposure estimate HQ > 42 (downwards spray); OECD Test Guideline 214 fdep values HQ > 85 (upwards/sideways) from Table H1a and further guidance in Appendix H Consider risk mitigation measures Reference to the EFSA Guidance Document of 4 July 2014 Chapter 9 Appendix S Consider further refinement of exposure estimate Semi-field and field effects studies EPPO 2010 and OECD Chapter 6.1.2 2007 with further details and Appendix as provided in Appendix O O especially regarding the use of statistics and the number of colonies and fields needed. Refined risk assessment for exposure via nectar and pollen following seed treatment or granule application applications Trigger value Guideline/test protocol Reference to the EFSA Guidance Document of 4 July 2014 Refined exposure estimates ETRacute > 0.2 OECD Test Guideline 213 Chapter 3.3.2 SV-values from Tables 5 ETRacute; for all relevant scenarios Jxx and Jyy as appropriate for the relevant scenario Ef values from Table X1c Consider risk mitigation measures Chapter 9 Appendix S Consider further refinement of exposure estimate Semi-field and field effects studies EPPO 2010 and OECD Chapter 6.1.2 2007 with further details and Appendix as provided in Appendix O O especially regarding the use of statistics and the number of colonies and fields needed. Refined risk assessment for contact exposure following seed treatment or granule application Trigger value Guideline/test protocol Reference to the EFSA Guidance Document of 4 July 2014 Refined exposure estimate HQ >14 OECD Test Guideline 214 Chapter 3.3.2 Ef-values from Table X1b SV-values from Table Jxx Consider risk mitigation measures Chapter 9 Appendix S 6 Consider further refinement of exposure estimate Semi-field and field effects studies EPPO 2010 and OECD Chapter 6.1.2 2007 with further details and Appendix as provided in Appendix O O especially regarding the use of statistics and the number of colonies and fields needed. 7 Part B Parts of the EFSA guidance document to be used for applications submitted at a date to be specified in a further Commission Notice on the implementation of a revised EFSA Guidance Document on the risk assessment for bees to be used for applications submitted after publication of the revised EFSA Guidance Document on the risk assessment for bees . HONEYBEES Chronic adults Larvae Guideline/test protocol Implementation date Reference to the EFSA Guidance Document of 4 July 2014 OECD Test Guideline 245 To be used for applications submitted at a date to be specified in a further Commission Notice on the implementation of a revised EFSA Guidance Document on the risk assessment for bees To be used for applications submitted after publication of the revised EFSA Guidance Document on the risk assessment for bees. Chapter 3.2.2 Table 3 OECD Guidance Document 239 To be used for applications submitted at a date to be specified in a further Commission Notice on the implementation of a revised EFSA Guidance Document on the risk assessment for bees.To be used for applications submitted after Chapter 3.3.2 Table 7 Chapter 3.5.2 Chapter 3.5.3 Ef-values from tables X1a and X2a as appropriate for the relevant scenario SV-values from Tables Jx and Jy as appropriate for the relevant scenario Ef values from Table 8 Guideline/test protocol Exposure from surface water (chronic risk) Implementation date publication of the revised EFSA Guidance Document on the risk assessment for bees Use highest PECsw from To be used for FOCUS step 1 or RAC for applications submitted at aquatic organisms. a date to be specified in a further Commission Notice on the implementation of a revised EFSA Guidance Document on the risk assessment for bees.To be used for applications submitted after publication of the revised EFSA Guidance Document on the risk assessment for bees Exposure from puddle water (chronic risk) Use run-off PEC values from To be used for FOCUS applications submitted at a date to be specified in a further Commission Notice on the implementation of a revised EFSA Guidance Document on the risk assessment for bees.To be used for applications submitted after publication of the revised EFSA Guidance Document on the risk assessment for bees Accumulative risk assessment Research still ongoing No protocols yet available Reference to the EFSA Guidance Document of 4 July 2014 X1c Chapter 9 Appendix S Chapter 6.1.2 and Appendix O To be used for Chapter 8 applications submitted 1 year after availability of internationally agreed 9 Guideline/test protocol Implementation date Reference to the EFSA Guidance Document of 4 July 2014 protocols Repeated exposure No protocols yet available laboratory test on larval development beyond pupation of honeybees To be used for applications submitted 1 year after availability of internationally agreed protocols Screening step for assessment of exposure to residues in honeydew No protocols yet available To be used for Chapter 3 applications submitted 1 and Chapter year after availability of 9 internationally agreed protocols Exposure from guttation fluid More information is needed on which crops and under what circumstances guttation droplets are produced and to what extent guttation droplets are used as a water source To be used for applications submitted at a date to be specified in a further Commission Notice on the implementation of a revised EFSA Guidance Document on the risk assessment for bees.To be used for applications submitted after publication of the revised EFSA Guidance Document on the risk assessment for bees Chapter 3.5.1 Extrapolation rules [to be verified if necessary to To be used for for residue trials maintain this line ] applications submitted at (minor crops, northa date to be specified in a south, etc.) further Commission Notice on the implementation of a revised EFSA Guidance Document on the risk assessment for bees.To be used for applications submitted after 10 Guideline/test protocol Implementation date Reference to the EFSA Guidance Document of 4 July 2014 publication of the revised EFSA Guidance Document on the risk assessment for bees Sublethal effects, More information is needed HPG and other methods to address No protocols yet available physiological effects, and effects on homing flight To be used for Appendix W applications submitted 1 year after availability of internationally agreed protocols Risk from exposure No protocols yet available to residues in succeeding crops To be used for applications submitted 1 year after availability of internationally agreed protocols Development of No protocols yet available landscape-level exposure assessment criteria/methods To be used for Chapter 5.1.5 applications submitted 1 year after availability of internationally agreed protocols BUMBLEBEES Screening step spray applications Guideline/test protocol Implementation date Reference to the EFSA Guidance Document of 4 July 2014 Acute adults OECD Test Guideline 247 To be used for applications Chapter 3.2.2 Table 3 8.2.1.1 oral 11 submitted at a Appendix P date to be specified in a further Commission Notice on the implementation of a revised EFSA Guidance Document on the risk assessment for bees To be used for applications submitted after publication of the revised EFSA Guidance Document on the risk assessment for bees Acute contact adults OECD Test Guideline 246 To be used for Chapter applications Table 2 submitted at a date to be specified in a further Commission Notice on the implementation of a revised EFSA Guidance Document on the risk assessment for bees To be used for applications submitted after publication of the revised EFSA Guidance 3.2.1 12 Document on the risk assessment for bees Screening step solid formulations Guideline/test protocol Implementation date Reference to the EFSA Guidance Document of 4 July 2014 Acute adults oral OECD Test Guideline 247 To be used for Chapter 3.3.2. applications Table 7 submitted at a date to be specified in a further Commission Notice on the implementation of a revised EFSA Guidance Document on the risk assessment for bees To be used for applications submitted after publication of the revised EFSA Guidance Document on the risk assessment for bees Acute contact adults OECD Test Guideline 246 To be used for applications submitted at a date to be specified in a further Chapter 3.3.1 fdep from Table H1b 13 Commission Notice on the implementation of a revised EFSA Guidance Document on the risk assessment for bees To be used for applications submitted after publication of the revised EFSA Guidance Document on the risk assessment for bees Chronic toxicity Guideline/test protocol Implementation date Reference to the EFSA Guidance Document of 4 July 2014 No protocols yet available To be used for Chapter 6.2.1 applications submitted at a date to be specified in a further Commission Notice on the implementation of a revised EFSA Guidance Document on the risk assessment for bees To be used for applications submitted after publication of the revised 14 EFSA Guidance Document on the risk assessment for bees Risk to larvae Higher studies tier No protocols yet available To be used for Chapter 6.2.1 applications submitted at a date to be specified in a further Commission Notice on the implementation of a revised EFSA Guidance Document on the risk assessment for bees To be used for applications submitted after publication of the revised EFSA Guidance Document on the risk assessment for bees To be used for applications submitted at a date to be specified in a further Commission Notice on the implementation of a revised EFSA Guidance Document on 15 the risk assessment for beesTo be used for applications submitted after publication of the revised EFSA Guidance Document on the risk assessment for bees Study with microcolonies To be used for applications submitted at a date to be specified in a further Commission Notice on the implementation of a revised EFSA Guidance Document on the risk assessment for bees To be used for applications submitted after publication of the revised EFSA Guidance Document on the risk assessment for bees Chapter 6.2.2 and Appendix P (with possibility for applicants to modify) Semi-field and combined field-tolaboratory tests To be used for applications submitted at a date to be specified in a further Chapter 6.2.2 and Appendix P (with possibility for applicants to 16 Commission modify) Notice on the implementation of a revised EFSA Guidance Document on the risk assessment for bees To be used for applications submitted after publication of the revised EFSA Guidance Document on the risk assessment for bees SOLITARY BEES Guideline/test protocol Acute contact A ring test is currently and the test itself is ready to be Implementation date Reference to the EFSA Guidance Document of 4 July 2014 To be used for Chapter applications 6.3.1 submitted 1 year after availability 17 Acute oral Chronic toxicity Risk to larvae implemented. However lack of guidance for higher tier testing. A ring-test is currently ongoing but more work is needed regarding feeding of Osmia with a specific amount of food. No protocols yet available. of internationally agreed protocols To be used for Chapter applications 6.3.1 submitted 1 year after availability of internationally agreed protocols To be used for applications submitted at a date to be specified in a further Commission Notice on the implementation of a revised EFSA Guidance Document on the risk assessment for bees To be used for applications submitted after publication of the revised EFSA Guidance Document on the risk assessment for bees No protocols yet To be used for available. applications submitted at a date to be specified in a further Commission Notice on the implementation Chapter 6.3.1 Chapter 6.3.2.1 18 Semi-field field test and of a revised EFSA Guidance Document on the risk assessment for bees Document on the risk assessment for bees.To be used for applications submitted after publication of the revised EFSA Guidance Document on the risk assessment for bees To be used for Chapter applications 6.3.2.2 and submitted at a 6.3.2.3 date to be specified in a further Commission Notice on the implementation of a revised EFSA Guidance Document on the risk assessment for bees To be used for applications submitted after publication of the revised EFSA Guidance Document on the risk assessment for bees 19 Part C Further actions proposed in order to allow for full implementation of the EFSA Guidance Document.  A review of the Guidance Document based on new scientific information and data.  Reconsideration of background mortality and trigger values.  Validation (cross-check) by using available higher tier data whether the level of conservatism introduced with current trigger values seems appropriate for different toxicity tests and exposure routes.  Detailed definition of protection goals for bumble bees and solitary bees.  Development of the following test: o Chronic oral toxicity test with bumble bees. o Larval toxicity test with bumble bees. o Accumulative toxicity risk assessment for bumble bees. o Field tests with bumble bees. o Chronic oral toxicity test with solitary bees. o Larval toxicity test with solitary bees. o Accumulative toxicity risk assessment for solitary bees. 20