20-23 November November ECHA Conference Centre (Annankatu 18, Helsinki)

Transcription

1 7 November 2018 RAC/A/47/2018 Final Draft Agenda 47 th meeting of the Committee for Risk Assessment November November 2018 ECHA Conference Centre (Annankatu 18, Helsinki) Tuesday 20 November starts at Friday 30 November ends at Item 1 Welcome and Apologies Item 2 Adoption of the Agenda RAC/A/47/2018 For adoption Item 3 Declarations of conflicts of interest to the Agenda Item 4 Appointment of (co-)rapporteurs a) Appointment of (co-)rapporteurs for CLH dossiers, restriction dossiers, authorisation applications and Article 77(3)(c) requests Item 5 Report from other ECHA bodies and activities a) Report on RAC 46 action points, written procedures and update on other ECHA bodies b) RAC workplan for all processes RAC/47/2018/01 (room document) 1

2 c) General RAC procedures d) INTERACT Project RAC/47/2018/02 RAC/47/2018/03 e) RAC Stakeholder Satisfaction Survey 2018 Item 6 Requests under Article 77(3)(c) 6.1 Copper compounds (M-factor) Item 7 Requests under Article 95 (3) None Harmonised classification and labelling (CLH) 8.1 General CLH issues 8.2 CLH dossiers A. Hazard classes for agreement without plenary debate (fast-track) potassium (oxido-nno-azoxy)cyclohexane; cyclohexylhydroxydiazene 1-oxide, potassium salt; [K-HDO]: physical hazards, acute toxicity, STOT SE, serious eye damage / eye irritation, skin sensitisation, germ cell mutagenicity, environmental hazards bis(n-hydroxy-n-nitrosocyclohexylaminato-o,o')copper; bis(n-cyclohexyldiazenium-dioxy)-copper; [Cu-HDO]: physical hazards, acute toxicity, STOT SE, serious eye damage / eye irritation, skin sensitisation, germ cell mutagenicity thiencarbazone-methyl (ISO): acute toxicity, STOT SE, skin corrosion / irritation, serious eye damage / eye irritation, STOT RE, germ cell mutagenicity, toxicity to reproduction, environmental hazards hexythiazox (ISO): environmental hazards flurochloridone (ISO): physical hazards, acute toxicity, STOT SE, skin corrosion / irritation, serious eye damage / eye irritation, skin sensitisation, STOT RE, germ cell mutagenicity, carcinogenicity, environmental hazards iprovalicarb (ISO): physical hazards, acute toxicity, skin corrosion / irritation, serious eye damage / eye irritation, skin sensitisation, germ cell mutagenicity, toxicity to reproduction, STOT SE, environmental hazards 2,4-Dinitrophenol: acute oral toxicity dibenzo[def,p]chrysene: germ cell mutagenicity 2

3 mancozeb (ISO): skin sensitisation, environmental hazards 4,5-dichloro-2-octyl-2H-isothiazol-3-one (DCOIT): physical hazards, acute dermal toxicity, germ cell mutagenicity, carcinogenicity, STOT RE pirimiphos-methyl (ISO): acute toxicity, germ cell mutagenicity, environmental hazards octhilinone (ISO); [OIT]: acute dermal toxicity, serious eye damage / eye irritation, STOT SE fluxapyroxad: physical hazards, acute toxicity, STOT SE, skin corrosion / irritation, serious eye damage / eye irritation, germ cell mutagenicity, environmental hazards, hazardous to ozone layer oxathiapiprolin (ISO): physical hazards, acute toxicity, STOT SE, skin corrosion / irritation, serious eye damage / eye irritation, respiratory or skin sensitisation, STOT RE, germ cell mutagenicity m-bis(2,3-epoxypropoxy)benzene; resorcinol diglycidyl ether: acute dermal toxicity Silthiofam (ISO): acute toxicity, skin corrosion / irritation, serious eye damage / eye irritation, skin sensitisation, STOT SE, germ cell mutagenicity, environmental hazards Pydiflumetofen: environmental hazards [HH to be confirmed] B. Hazard classes for agreement with plenary debate 1) potassium (oxido-nno-azoxy)cyclohexane; cyclohexylhydroxydiazene 1- oxide, potassium salt; [K-HDO] 2) bis(n-hydroxy-n-nitrosocyclohexylaminato-o,o')copper; bis(n-cyclohexyldiazenium-dioxy)-copper; [Cu-HDO] 3) thiencarbazone-methyl (ISO); methyl 4-[(4,5-dihydro-3-methoxy-4-methyl- 5-oxo-1H-1,2,4-triazol-1-yl)carbonylsulfamoyl]-5- methylthiophene-3- carboxylate 4) 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4- stannatetradecanoate; [DOTE] 5) hexythiazox (ISO); trans-5-(4-chlorophenyl)-n-cyclohexyl-4-methyl-2-oxo- 3-thiazolidine-carboxamide 6) flurochloridone (ISO); 3-chloro-4-(chloromethyl)-1-[3- (trifluoromethyl)phenyl]pyrrolidin-2-one 7) iprovalicarb (ISO) isopropyl [(2S)-3-methyl-1-{[1-(4- methylphenyl)ethyl]amino}-1-oxobutan-2-yl]carbamate 8) 2,4-dinitrophenol 9) phosphine 10) dibenzo[def,p]chrysene 11) mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt 12) 2-(4-tert-butylbenzyl)propionaldehyde 13) 4,5-dichloro-2-octyl-2H-isothiazol-3-one (DCOIT) 14) pirimiphos-methyl (ISO) 15) octhilinone (ISO); 2-octyl-2H-isothiazol-3-one; [OIT] 16) 3-(difluoromethyl)-1-methyl-N-(3',4',5'-trifluorobiphenyl-2-yl)pyrazole-4- carboxamide; fluxapyroxad 17) oxathiapiprolin (ISO); 1-(4-{4-[5-(2,6-difluorophenyl)-4,5-dihydro-1,2-3

4 oxazol-3-yl]-1,3-thiazol-2-yl}piperidin-1-yl)-2-[5-methyl-3-(trifluoromethyl)- 1H-pyrazol-1-yl]ethanone 18) m-bis(2,3-epoxypropoxy)benzene 19) silthiofam (ISO); N-allyl-4,5-dimethyl-2-(trimethylsilyl)thiophene-3- carboxamide 20) N-methoxy-N-[1-methyl-2-(2,4,6-trichlorophenyl)-ethyl]-3-(difluoromethyl)- 1-methylpyrazole-4-carboxamide; pydiflumetofen 21) hexyl 2-(1-(diethylaminohydroxyphenyl)methanoyl) benzoate 22) lead and adoption Item 9 Restrictions 9.1 Restriction Annex XV dossiers a) Conformity check and key issues discussion 1) N,N-dimethylformamide 2) Five cobalt salts b) Opinion development 1) Plastic and rubber granulates containing PAHs first draft opinion 2) Substances used in tattoo inks and permanent make-up final draft opinion For adoption Item 10 Authorisation 10.1 General authorisation issues a) Update on incoming/future applications b) AfA A-listing draft procedure RAC/47/2018/ Authorisation applications a) Agreement on draft opinions 1. CT_MAHLE (1 use) 4

5 2. CT_Doosan (1 use) and agreement b) Adoption of final opinions 1. CT_Hapoc_2 (1 use) and adoption Review reports a) Discussion on key issues 1. RR1_TCE_Spolana c) Adoption of final opinions a. RR1_DEHP_PP (2 uses) and adoption Item 11 AOB Item 12 Action points and main conclusions of RAC-47 Table with Conclusions and Action points from RAC-47 For adoption 5

6 PROVISIONAL TIMELINE FOR THE DISCUSSIONS AT RAC-47 Please note that this timeline is provisional. Changes can be made before and during the meeting in order to accommodate the discussions. WEEK 1 Item 1 Item 2 Item 3 Item 5 Item 9 Tuesday 20 November: Afternoon session Welcome and Apologies Adoption of the Agenda Declarations of conflicts of interest to the Agenda - Report from other ECHA bodies and activities - Restrictions Item 9 Item 10 - Restrictions Wednesday 21 November: Morning session - Authorisation applications Item 10 : Wednesday 21 November: Afternoon session - Authorisation applications : Thursday 22 November: Morning session Thursday 22 November: Afternoon session : Item 6: - Request under Article 77(3) : Friday 23 November: Morning session 6

7 WEEK 2 Item 1 Item 3 Tuesday 27 November: Morning session Welcome and Apologies Declarations of conflicts of interest to the Agenda Tuesday 27 November: Afternoon session Wednesday 28 November: Morning session Wednesday 28 November: Afternoon session Thursday 29 November: Morning session Thursday 29 November: Afternoon session Friday 30 November: Morning session Item 4 -Appointment of rapporteurs 7