Draft Agenda 23 rd meeting of the Member State Committee

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ECHA/MSC-23/2012/A/23 Draft agenda Draft Agenda 23 rd meeting of the Member State Committee 24-27 April 2012 ECHA Conference Centre Annankatu 18, in Helsinki, Finland 24 April: starts at 9:00 27 April: ends at 13:00 Item 1 Welcome and Apologies Item 2 Adoption of the Agenda MSC/A/023/2012 Item 3 Declarations of conflicts of interest to items on the Agenda Item 4 Administrative issues Meeting calendar for 2013 ECHA/MSC-23/2012/37 Item 5 Adoption of the draft minutes and conclusions and action points of the MSC-22 Draft minutes of the MSC-22 MSC/M/22/2012 Item 6 Dossier evaluation Closed session for Session 1 on TPE-10/2012 and for 6d Indicative time plan for 6c is Day 1& 2, for 6d Day 3&4 a. General topics: 1. 2 nd species in developmental toxicity testing

and discussion 2. Selection of route of administration for human health higher tier testing and discussion 3. Read-Across Assessment Framework development/principles of the second tier (Tier II) and discussion 4. Update by Commission representative on Use of the Extended One- Generation Reproductive Toxicity Study (EOGRTS) under REACH and CLP ECHA/MSC-23/2012/39 5. Proposal for organisation of the MSC work for high number of dossier evaluation cases (Partly closed session) Feedback from case-owner and stakeholder participation discussion in the Management Board ECHA/MSC-23/2012/036 and agreement 6. Status report on ongoing evaluation work b. Written procedure reports on seeking agreement on draft decisions on dossier evaluation ECHA/MSC-23/2012/002 c. Introduction to and preliminary discussion on draft decisions on compliance checks and testing proposals after MS-CA reactions (Session 1, tentatively open session except for TPE-010) followed by agreement seeking under 6c: ECHA/MSC-23/2012/001 - CCH-003/2012 Dichloro(dimethyl)silane (EC No. 200-901-0) ECHA/MSC-23/2012/030-031 - CCH-004/2012 Silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)- (EC No. 213-668- 5) ECHA/MSC-23/2012/003-004 - TPE-002/2012 2,2-bis(hydroxymethyl)propionic acid (EC No. 225-306-3) ECHA/MSC-23/2012/015-016 - TPE-010/2012 (Closed session) ECHA/MSC-23/2012/021-022 - CCH-006/2012 Tert-butyl hydroperoxide (EC No. 200-915-7) ECHA/MSC-23/2012/006-007 - CCH-008/2012 Vinyl 2-ethylhexanoate (EC No. 202-297-4) ECHA/MSC-23/2012/009-010 - TPE-023/2012 Silicon (EC No. 231-130-8) ECHA/MSC-23/2012/018-019

- TPE-033/2012 Sodium hydroxymethanesulphinate (EC No. 205-739-4) ECHA/MSC-23/2012/012-013 - TPE-038B/2012 2-Ethylhexyl Nitrate (EC No. 248-363-6) ECHA/MSC-23/2012/024-025 - TPE-048/2012 Tert-butyl 2-ethylperoxyhexanoate (EC No. 221-110-7) ECHA/MSC-23/2012/027-028 and discussion d. Seeking agreement on draft decisions on compliance checks and testing proposals when amendments were proposed by MS s (Session 2, closed) - CCH-003/2012 Dichloro(dimethyl)silane (EC No. 200-901-0) ECHA/MSC-23/2012/030-032 - CCH-004/2012 Silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)- (EC No. 213-668- 5) ECHA/MSC-23/2012/003-005 - TPE-002/2012 2,2-bis(hydroxymethyl)propionic acid (EC No. 225-306-3) ECHA/MSC-23/2012/015-017 - TPE-010/2012 ECHA/MSC-23/2012/021-023 - CCH-006/2012 Tert-butyl hydroperoxide (EC No. 200-915-7) ECHA/MSC-23/2012/006-008 - CCH-008/2012 Vinyl 2-ethylhexanoate (EC No. 202-297-4) ECHA/MSC-23/2012/009-011 - TPE-023/2012 Silicon (EC No. 231-130-8) ECHA/MSC-23/2012/018-020 - TPE-033/2012 Sodium hydroxymethanesulphinate (EC No. 205-739-4) ECHA/MSC-23/2012/012-014 - TPE-038B/2012 2-Ethylhexyl Nitrate (EC No. 248-363-6) ECHA/MSC-23/2012/024-026 - TPE-048/2012 Tert-butyl 2-ethylperoxyhexanoate (EC No. 221-110-7) ECHA/MSC-23/2012/027-029 Cases returned from written procedures for agreement seeking in the meeting: 1 - TPE-018/2012 2-Octyldodecan-1-ol (EC No. 226-242-9) ECHA/MSC/D/2012/054-056 - TPE-025/2012 (1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate BDP (EC No. 425-220-8) ECHA/MSC/D/2012/063-065 - TPE-026/2012 (1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate BDP (new registration) (EC No. 425-220-8) ECHA/MSC/D/2012/066-068 - TPE-027/2012 Benzene, 1,1'-oxybis-, tetrapropylene derivs., sulfonated, sodium salts (DOWFAX 2A1) (List number 601-601-6) ECHA/MSC/D/2012/069-071 - TPE-028B/2012 Hydroxycyclohexyl phenyl ketone (EC No. 213-426-9) ECHA/MSC/D/2012/124, 125 & 127 1 Note to members: The documents listed for each case here may be found in the substance specific folders in CIRCABC, as were made available for the written procedures, and are not available in the MSC- 23 folders.

- TPE 040/2012 Dust, steelmaking (EC No. 266-005-7) ECHA/MSC/D/2012/101-103 - TPE-049/2012 Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts (EC No. 931-534-0) - TPE-056/2012 Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4- hydroxyphenyl)propionate) (EC No. 229-722-6) ECHA/MSC/D/2012/0083-085 ECHA/MSC/D/2012/089-091 - TPE-57B/2012 Strontium nitrate (EC No. 233-131-9) ECHA/MSC/D/2012/119, 120 & 122 For agreement e. Items for discussion following commenting by MSCAs (Tentatively closed session) Items from the MSCA commenting round for MSC-24, including some consistency proposals from DK Item 7 Authorisation process 1. SVHC identification process a) Multiple entries for Refractory Ceramic Fibres on the candidate list potential corrective measures b) SVHC time schedule for 2012 ECHA/MSC-23/2012/33 2. Recommendation of substances for Annex XIV inclusion a) Discussion of the draft recommendation/prioritisation results ECHA/MSC-23/2012/034 & 035 b) Time-table of MSC for drafting the opinion on ECHA s draft recommendation on priority substances for Annex XIV ECHA/MSC-23/2012/037 For decision Item 8 Manual of Decisions (MoD) Any topics identified by members Item 9 Report from other ECHA bodies and activities Closed session for 9a a) Management of MSC documents

and discussion b) Report from the 1 st ECHA PBT working group Item 10 Any other business Suggestions from members: GLP: Systematic feedback and EU collaboration Exposure assessment in Tier 1 Item 11 Adoption of conclusions and action points Table with action points and decisions from MSC-23

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