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Permethrin Product-Type 18 (Insecticides, Acaricides and Products to Control Other Arthropods)

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Permethrin Product-Type 18 (Insecticides, Acaricides and Products to Control Other Arthropods) Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products Evaluation of active substances Assessment Report Permethrin Product-Type 18 (Insecticides, acaricides and products to control other arthropods) Rapporteur: Ireland April 2014 Permethrin Product-type 18 April 2014 Permethrin PT18 Assessment report CONTENTS 1. Statement Of Subject Matter And Purpose ..................................... 3 1.1. Procedure Followed ............................................................... 3 1.2. Purpose Of The Assessment Report .......................................... 4 2. Overall Summary And Conclusions ............................................... 5 2.1. Presentation Of The Active Substance ...................................... 5 2.1.1. Identity, Physico-Chemical Properties And Methods Of Analysis ..................................................................................... 5 2.1.2. Intended Uses And Efficacy ............................................... 8 2.1.3. Classification And Labelling .............................................. 11 2.2. Summary Of The Risk Assessment ......................................... 15 2.2.1. Human Health Risk Assessment ....................................... 16 2.2.2. Environmental Risk Assessment ....................................... 28 2.2.3. List Of Endpoints ............................................................ 45 2.2.4. Conclusions and Decision of the Assessment Report ............. 44 Appendix I: List Of Endpoints .......................................................... 46 Chapter 1: Identity, Physical And Chemical Properties, Classification And Labelling ................................................................................ 46 Chapter 2:Methods Of Analysis ..................................................... 50 Chapter 3:Impact On Human Health ............................................. 52 Chapter 4:Fate And Behaviour In The Environment ......................... 56 Chapter 5:Effects On Non-Target Species ...................................... 70 Chapter 6:Other Endpoints .......................................................... 73 Appendix II: List Of Intended Uses .................................................. 74 Appendix III: List Of Studies ........................................................... 76 2 Permethrin Product-type 18 April 2014 1. STATEMENT OF SUBJECT MATTER AND PURPOSE 1.1. PROCEDURE FOLLOWED This assessment report has been established as a result of the evaluation of Permethrin as product-type 18 (insecticide), 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. Permethrin (CAS no. 52645-53-1) was notified as an existing active substance, by Tagros Chemicals India Ltd and by TANATEX B.V., hereafter referred to as the applicant, in product-type 18. It should be noted: The application in support of permethrin by TANATEX B.V. was originally submitted under product-type 9 (fibre, leather, rubber and polymerised materials preservatives). However, following discussions at the Competent Authority meeting in Brussels during July 2011 it was determined and concluded: “The meeting took note of the document submitted by Tanatex on the subject of the change of PT (from PT 9 to 18) for the dossier submitted for permethrin under the review programme. The meeting however concluded that the protection of wool carpets against larvae of moths and carpets beetles should fall under PT 18, as PT 9 cover substances intended to protect textiles from micro-organisms only. However, it was noted that the ESD for PT9 could be utilised for this assessment.” Commission Regulation (EC) No. 1451/2007 of 4 December 20071 lays down the detailed rules for the evaluation of dossiers and for the decision-making process. In accordance with the provisions of Article 7(1) of that Regulation, Ireland 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 Permethrin as an active substance in product-type 18 was 30 April 2006, in accordance with Annex V of Regulation (EC) No. 1451/2007. On 28 April 2006, the Irish competent authorities received a dossier from the applicant Tagros. The Rapporteur Member State accepted the dossier as complete for the purpose of the evaluation on 26 June 2008, following an extension of the completeness check period in order that additional data could be submitted. On 27 January 2009, the Irish competent authorities received a dossier from the applicant TANATEX B.V. (with a letter of Access to data on permethrin held by Bayer Environmental Science). Following an extension of the completeness check period to the 30 June 2009, the Rapporteur Member State accepted the dossier as complete for the purpose of the evaluation on 19 June 2009. On 21 June 2010, the Rapporteur Member State submittedto the Commission and the applicant a copy of the evaluation report, hereafter referred to as the competent authority report. In accordance with Article 16 of Regulation (EC) No 1451/2007, the Commission made the competent authority report publicly available by electronic means on 22 June 2010. This report did not include such information that was to be treated as confidential in accordance with Article 19 of Directive 98/8/EC. 1 Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market. OJ L 325, 11.12.2007, p. 3 3 Permethrin Product-type 18 April 2014 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 Commission. Revisions agreed upon were presented at technical and competent authority meetings and the competent authority report was amended accordingly. 1.2. PURPOSE OF THE ASSESSMENT REPORT The aim of the assessment report is to support the opinion of the Biocidal Products Committee and a decision on the approval of Permethrin 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. 4 Permethrin Product-type 18 April 2014 2. OVERALL SUMMARY AND CONCLUSIONS 2.1. PRESENTATION OF THE ACTIVE SUBSTANCE 2.1.1. Identity, Physico-Chemical Properties and Methods of Analysis CAS No.: 52645-53-1 EC No.: 258-067-9 Other No. (CIPAC, ELINCS): 331 (CIPAC) IUPAC Name: 3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2- dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate CA Name: (3-phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)- 2,2-dimethylcyclopropanecarboxylate Common name, synonym: Permethrin Molecular formula: C21H20Cl2O3 Purity: Permethrin has four stereoisomers: 1Rcis, 1Scis, 1Rtrans, and 1Strans. Two pairs of diastereomers (each consisting of a non- racemic pair of enantiomers) are present in a ratio of ca. 25:75 Specification ≥93.0% w/w sum of all isomers Permethrin is a reaction mass of four stereoisomers 1Rcis permethrin content = 5.0 – 10.0% w/w. 1Scis permethrin content = 15.0 – 20.0% w/w. 1Rtrans permethrin content = 45.0 – 55.0% w/w. 1Strans permethrin content = 17.0 – 27.0% w/w. Structural formula 1Rcis isomer – 1Scis isomer – 5 Permethrin Product-type 18 April 2014 1Rtrans isomer – 1Strans isomer – Molecular weight (g/mol): 391.29 g/mol Application in support of permethrin PT18 was received from two notifiers - TANATEX B.V. (with access to the Bayer Environmental Science/Sumitomo Chemicals (UK) Ltd source of permethrin) and Tagros Chemicals India Ltd. Permethrin technical (CAS number 52645-53-1) is manufactured in India by Bilag Industries for Bayer Environmental Science/Sumitomo Chemicals (UK) Ltd. Tagros Chemicals India Ltd manufactures its’ own source of Permethrin technical. The minimum purities of the Tagros and Bayer sources of technical material are based on representative batch data from the respective manufacturing facilities. The minimum purity of the Tagros source is 93% w/w sum of all permethrin isomers. Total cis range: 25 – 28% ratio Total trans range: 72-75% ratio 1Rcis range: 7.9 – 8.3% w/w. 1Scis range: 15.8 – 16.7% w/w. 1Rtrans range: 45.4 – 46.1% w/w. 1Strans range: 22.5 – 23.0 % w/w. The minimum purity of the Bayer source is 95% w/w sum of all permethrin isomers. Total cis range: 22 – 28% ratio Total trans range: 72-78% ratio 1Rcis range: 5.0 – 10.0% w/w. 1Scis range: 15-20% w/w. 1Rtrans range: 45 – 55% w/w. 1Strans range: 17 – 27 % w/w. Following evaluation of the confidential data supplied by the two notifiers, Bayer/Sumitomo and Tagros Ltd., it is
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