Regulation (EU) n°528/2012 concerning the making available on the market and use of biocidal products Evaluation of active substances Assessment Report EMPENTHRIN Product-Type 18 (Insecticide) March 2019 (revised version) RMS = Belgium Competent EMPENTHRIN Assessment Authority Report: Report Belgium March 2018 Table of Contents 1 STATEMENT OF SUBJECT MATTER AND PURPOSE ..................................................................... 3 1.1 PRINCIPLE OF EVALUATION ....................................................................................................................... 3 1.2 PURPOSE OF THE ASSESSMENT ................................................................................................................... 3 1.3 PROCEDURE FOLLOWED ............................................................................................................................ 3 2 OVERALL SUMMARY AND CONCLUSIONS ..................................................................................... 5 2.1 PRESENTATION OF THE ACTIVE SUBSTANCE ............................................................................................. 5 2.1.1 Identity, Physico-Chemical Properties & Methods of Analysis ...................................................... 5 2.1.2 Intended Uses and Efficacy ............................................................................................................. 7 2.1.3 Classification and Labelling ........................................................................................................... 8 2.2 SUMMARY OF THE RISK ASSESSMENT ....................................................................................................... 9 2.2.1 Human Health Risk Assessment ...................................................................................................... 9 2.2.2 Environmental Risk Assessment .................................................................................................... 19 3 EXCLUSION CRITERIA ........................................................................................................................ 26 3.1 EXCLUSION CRITERIA .............................................................................................................................. 26 3.1.1 Assessment of CMR properties ...................................................................................................... 26 3.1.2 Assessment of endocrine disrupting properties ............................................................................. 27 3.1.3 PBT Assessment (following Annex XIII to Regulation (EC) No 1907/2006) ................................. 28 3.2 SUBSTITUTION CRITERIA.......................................................................................................................... 35 3.3 ASSESSMENT OF LONG-RANGE ENVIRONMENTAL TRANSPORTATION AND IMPACT ON ENVIRONMENTAL COMPARTMENTS ................................................................................................................................................ 36 4 DECISION ................................................................................................................................................. 37 4.1 BACKGROUND TO THE PROPOSED DECISION ............................................................................................. 37 4.2 REQUIREMENT FOR FURTHER INFORMATION ............................................................................................ 37 4.3 UPDATING THIS ASSESSMENT REPORT ..................................................................................................... 37 APPENDIX 1 : LISTING OF END POINTS ................................................................................................... 38 Chapter 1: Identity, Physical and Chemical Properties, Details of Uses, Further Information, and Proposed Classification and Labelling........................................................................................................ 38 Chapter 2: Methods of Analysis ............................................................................................................. 40 Chapter 3: Impact on Human Health ..................................................................................................... 42 Chapter 4: Fate and Behaviour in the Environment .............................................................................. 49 Chapter 5: Effects on Non-target Species .............................................................................................. 51 Chapter 6: Other End Points ................................................................................................................. 53 APPENDIX 2 : LIST OF INTENDED USES ................................................................................................... 54 APPENDIX 3 : LIST OF STUDIES .................................................................................................................. 55 Page 2 of 72 Competent EMPENTHRIN Assessment Authority Report: Report Belgium March 2018 1 STATEMENT OF SUBJECT MATTER AND PURPOSE 1.1 PRINCIPLE OF EVALUATION This assessment report has been established as a result of the evaluation of the active substance EMPENTHRIN as product-type 18 (Insecticides, acaricides and products to control other arthropods) carried out in the context of the work programme for the review of existing active substances provided for in Article 89 of Regulation (EU) No 528/2012, with a view to the possible approval of this substance. 1.2 PURPOSE OF THE ASSESSMENT The aim of the assessment report is to support the opinion of the Biocidal Products Committee and a decision on the approval of EMPENTHRIN for product-type 18, and, should it be approved, to facilitate the authorisation of individual biocidal products. In the evaluation of applications for product- authorisation, the provisions of Regulation (EU) No 528/2012 shall be applied, in particular the provisions of Chapter IV, as well as the common principles laid down in Annex VI. For the implementation of the common principles of Annex VI, the content and conclusions of this assessment report, which is available from the Agency web-site shall be taken into account. However, where conclusions of this assessment report are based on data protected under the provisions of Regulation (EU) No 528/2012, such conclusions may not be used to the benefit of another applicant, unless access to these data for that purpose has been granted to that applicant. 1.3 PROCEDURE FOLLOWED This assessment report has been established as a result of the evaluation of the active substance EMPENTHRIN as product-type 18 (Insecticides, acaricides and products to control other arthropods) carried out in the context of the work programme for the review of existing active substances provided for in Article 89 of Regulation (EU) No 528/2012, with a view to the possible approval of this substance. EMPENTHRIN (CAS no. 54406-48-3) was notified as an existing active substance, by Sumitomo Chemical (UK) plc, hereafter referred to as the applicant, in product-type 18. Commission Regulation (EC) No 1451/2007 of 4 December 2007 lays down the detailed rules for the evaluation of dossiers and for the decision-making process.. Page 3 of 72 Competent EMPENTHRIN Assessment Authority Report: Report Belgium March 2018 In accordance with the provisions of Article 7(1) of that Regulation, Belgium was designated as Rapporteur Member State to carry out the assessment on the basis of the dossier submitted by the applicant. The deadline for submission of a complete dossier for EMPENTHRIN as an active substance in Product Type 18 was April 30th 2006, in accordance with Annex V of Regulation (EC) No 1451/2007. On 26/04/2006, BELGIUM competent authorities received a dossier from the applicant. The Rapporteur Member State accepted the dossier as complete for the purpose of the evaluation on 31/01/2007. On 24/06/2016, the Rapporteur Member State submitted to the Commission and the applicant a copy of the evaluation report, hereafter referred to as the competent authority report. Please note that in February 2014 the first draft CAR was submitted. This submission was rejected because the P (persistence) assessment was unclear and no CLH dossier was submitted. Based on this no acceptance, the eCA enhanced the P-assessment and finalized the CLH. In order to review the competent authority report and the comments received on it, consultations of technical experts from all Member States (peer review) were organised by the Agency. Revisions agreed upon were presented at the Biocidal Products Committee and its Working Groups meetings and the competent authority report was amended accordingly. The competent authority report included a recommendation for the non-approval of EMPENTHRIN. Page 4 of 72 Competent EMPENTHRIN Assessment Authority Report: Report Belgium March 2018 2 OVERALL SUMMARY AND CONCLUSIONS 2.1 PRESENTATION OF THE ACTIVE SUBSTANCE 2.1.1 Identity, Physico-Chemical Properties & Methods of Analysis 2.1.1.1 Identity The exact identity of the active substance could not be proven due to the lack of a validated analytical method. CAS-No. 54406-48-3 * EINECS-No. / Other No. (CIPAC, ELINCS) / 1-ethynyl-2-methylpent-2-enyl 2,2-dimethyl-3-(2-methylprop-1- IUPAC Name enyl) cyclopropanecarboxylate Common name, Synonym - Molecular formula C18H26O2 H3C CH3 CH3 CH3 C H E O Structural formula 2 5 R C CH3 HC C O Molecular weight (g/mol) 274.40 g/mol Purity of a.s. > 96% * According to the discussion during