European Commission Proposal for Harmonised Classification and Labelling Based on Regulation (EC) No 1272/2008 (CLP Regulation) CLOMAZONE Volume 1 Clomazone (ISO); 2-(2-chlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one EC: - CAS: 81777-89-1 Rapporteur Member State: Denmark Co-Rapporteur Member State: Germany September 2018 Clomazone Volume 1 Version History When What 2005/March Initial DAR 2005/June Revised Vol. 1 2018/January Draft RAR 2018/October Revised vol. 1 according to ECHA accordance check. 2 Clomazone Volume 1 Table of contents RAPPORTEUR MEMBER STATE: DENMARK ............................................................................................. 1 1 STATEMENT OF SUBJECT MATTER AND PURPOSE FOR WHICH THIS REPORT HAS BEEN PREPARED AND BACKGROUND INFORMATION ON THE APPLICATION ................................... 9 1.1 CONTEXT IN WHICH THIS DRAFT ASSESSMENT REPORT WAS PREPARED ................................................ 9 1.1.1 Purpose for which the draft assessment report was prepared ............................................................. 9 1.1.2 Arrangements between rapporteur Member State and co-rapporteur Member State .......................... 9 1.1.3 EU Regulatory history for use in Plant Protection Products .............................................................. 9 1.1.4 Evaluations carried out under other regulatory contexts .................................................................. 10 1.2 APPLICANT INFORMATION ..................................................................................................................... 10 1.2.1 Name and address of applicant(s) for approval of the active substance ........................................... 10 1.2.2 Producer or producers of the active substance ................................................................................. 12 1.2.3 Information relating to the collective provision of dossiers ............................................................. 13 1.3 IDENTITY OF THE ACTIVE SUBSTANCE ................................................................................................... 13 1.3.1 Common name proposed or ISO-accepted and synonyms ............................................................... 13 1.3.2 Chemical name (IUPAC and CA nomenclature) ............................................................................. 13 1.3.3 Producer’s development code number ............................................................................................. 13 1.3.4 CAS, EEC and CIPAC numbers ..................................................................................................... 13 1.3.5 Molecular and structural formula, molecular mass .......................................................................... 13 1.3.6 Method of manufacture (synthesis pathway) of the active substance............................................... 14 1.3.7 Specification of purity of the active substance in g/kg .................................................................... 14 1.3.8 Identity and content of additives (such as stabilisers) and impurities .............................................. 14 1.3.8.1 Additives ............................................................................................................................................... 14 1.3.8.2 Significant impurities ............................................................................................................. 14 1.3.8.3 Relevant impurities ................................................................................................................. 14 1.3.9 Analytical profile of batches ........................................................................................................... 14 1.4 INFORMATION ON THE PLANT PROTECTION PRODUCT .......................................................................... 14 B.1.1.1. Applicant ......................................................................................................................................................... 14 B.1.1.2. Producer of the plant protection product .......................................................................................... 14 B.1.1.3. Trade name or proposed trade name and producer's development code number of the plant protection product ........................................................................................................................... 14 B.1.1.4. Detailed quantitative and qualitative information on the composition of the plant protection product ........................................................................................................................................................ 14 B.1.1.4.1. Composition of the plant protection product .......................................................................... 15 B.1.1.4.2. Information on the active substances ...................................................................................... 15 B.1.1.4.3. Information on safeners, synergists and co-formulants ........................................................... 15 B.1.1.5. Type and code of the plant protection product ................................................................................. 15 B.1.1.6. Function ........................................................................................................................................................... 15 B.1.1.7. Field of use envisaged ...................................................................................................................... 15 B.1.1.8. Effects on harmful organisms ........................................................................................................... 15 1.4.1 Applicant ........................................................................................................................................................ 15 1.4.2 Producer of the plant protection product ......................................................................................... 16 1.4.3 Trade name or proposed trade name and producer's development code number of the plant protection product ........................................................................................................................... 16 1.4.4 Detailed quantitative and qualitative information on the composition of the plant protection product ............................................................................................................................................................ 16 1.4.4.1 Composition of the plant protection product .......................................................................... 16 1.4.4.2 Information on the active substances ...................................................................................... 16 1.4.4.3 Information on safeners, synergists and co-formulants ........................................................... 16 3 Clomazone Volume 1 1.4.5 Type and code of the plant protection product ................................................................................ 16 1.4.6 Function .......................................................................................................................................... 16 1.4.7 Field of use envisaged ..................................................................................................................... 17 1.4.8 Effects on harmful organisms ......................................................................................................... 17 1.5 DETAILED USES OF THE PLANT PROTECTION PRODUCT ........................................................................ 17 1.5.1 Details of representative uses .......................................................................................................... 18 1.5.2 Further information on representative uses ..................................................................................... 20 1.5.3 Details of other uses applied for to support the setting of MRLs for uses beyond the representative uses ................................................................................................................................................. 20 1.5.4 Overview on authorisations in EU Member States ......................................................................... 20 2 SUMMARY OF ACTIVE SUBSTANCE HAZARD AND OF PRODUCT RISK ASSESSMENT ........ 25 2.1 IDENTITY ................................................................................................................................................ 30 2.1.1 Summary of identity ....................................................................................................................... 30 2.2 PHYSICAL AND CHEMICAL PROPERTIES [EQUIVALENT TO SECTION 7 OF THE CLH REPORT TEMPLATE] ............................................................................................................................................. 31 2.2.1 Summary of physical and chemical properties of the active substance ........................................... 31 2.2.1.1 Evaluation of physical hazards [equivalent to section 8 of the CLH report template] ............ 38 2.2.2 Summary of physical and chemical properties of the plant protection product .............................. 43 2.3 DATA ON APPLICATION AND EFFICACY .................................................................................................. 43 2.3.1 Summary of effectiveness ..............................................................................................................