4. Agreement of the minutes and review of actions from BPC Housekeeping issues For information
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1 10 September 2018 BPC-A Draft agenda 27 th meeting of the Biocidal Products Committee (BPC) October 2018 ECHA Conference Centre, Annankatu 18, Helsinki Starts on 16 October at 09:30, ends on 18 October at 16:00 1. Welcome and apologies 2. Agreement of the agenda BPC-A Declarations of potential conflicts of interest to agenda items 4. Agreement of the minutes and review of actions from BPC-26 BPC-M Administrative issues 5.1. Housekeeping issues 5.2. Other administrative issues and report from other Committees BPC Work programme for BPC 6.1. Revised BPC Work Programme BPC
2 6.2. Outlook for BPC BPC Status harmonised classification and labelling for active substances BPC Applications for approval of active substances * 7.1. Procedural and administrative aspects: Template BPC opinion for active substance approval BPC Catalogue of specific conditions and elements to be taken into account at the product authorisation stage for active substance approval BPC Presentation of PBT status in BPC opinion: potential PBTs BPC Draft BPC opinion on silver zinc zeolite for PT 2, 4, 7 and 9 Previous discussion(s): TM-II-2013, TM-IV-2013, WG-III-2015, WG-III- 2016,WG-V-2016, WG-V-2017 BPC A, B, C 7.3. Draft BPC opinion on silver zeolite for PT 2, 4, 7 and 9 Previous discussion(s): WG-V-2017 BPC A, B, C 7.4. Draft BPC opinion on silver copper zeolite for PT 2, 4, 7 and 9 Previous discussion(s): WG-V-2017 BPC A, B, C * For the discussions of the draft BPC opinions at least the following documents will be distributed: a draft BPC opinion (denoted by A), a draft assessment report (AR) which may cover more than one PT (denoted by B) and a document containing open issues covering all the PTs to be discussed for that substance (denoted by C). 2
3 7.5. Draft BPC opinion on silver sodium hydrogen zirconium phosphate for PT 2, 4, 7 and 9 Previous discussion(s): WG-V-2017 BPC A, B, C 7.6. Revised Assessment Report following the submission of data after active substance approval: Formaldehyde for PT 3 BPC Margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide for PT 19 BPC octyl-isothiazol-3(2H)-one (OIT) for PT 8 BPC epsilon-momfluorothrin for PT 18 BPC Bacillus thuringiensis subsp. kurstaki, serotype 3a3b, strain ABTS-351for PT 18 BPC Requesting further information as new test guidelines become available BPC Terminology primary and secondary exposure in the BPC opinion BPC
4 Item 8 Union authorisation 8.1 Update on Union authorisation 8.2 Draft BPC opinions on Union authorisation applications for a product family containing iodine / PVP-iodine Previous discussion(s): WG-IV-2018 BPC A, B, C, D 8.3 Working procedure for applications for major change of a Union authorisation BPC Union authorisation major change applications: cooperation during the evaluation stage BPC Item 9 Article 38 opinions 9.1 Draft BPC opinion on Questions on unresolved objections during mutual recognition of a PT 18 biocidal product family containing 1R-trans phenothrin for use against ants BPC A Item 10 Any other business Item 11 Action points and conclusions For the discussions of the draft BPC opinions at least the following documents will be distributed: a draft BPC opinion (denoted by A), a draft Summary of Product Characteristics (SPC) (denoted by B), a draft product assessment report (PAR) (denoted by C) and a document containing open issues to be discussed for the biocidal product or biocidal product familiy (denoted by D). 4
5 Provisional time schedule for the 27 th meeting of the Biocidal Products Committee (BPC) ECHA Conference Centre, Annankatu 18, Helsinki 16 October 2018: starts at 09:30; 18 October 2018 ends at 16:00 Please note that the time schedule indicated below are provisional and subject to possible change. The schedule is distributed to participants on a preliminary basis. If needed, followup discussions may take place on the following day for BPC opinions. Tuesday 16 October: morning session Items 1-5 Opening items and administrative issues Item 6 Work programme of the BPC Item 7.1 Procedural and administrative aspects: Template BPC opinion for active substance approval Catalogue of specific conditions and elements to be taken into account at the product authorisation stage for active substance approval Item 7.7 Item Presentation of PBT status in BPC opinion: potential PBTs Requesting further information as new test guidelines become available Terminology primary and secondary exposure in the BPC opinion Tuesday 16 October: afternoon session Item BPC opinions on silver: 7.2. Draft BPC opinion on silver zinc zeolite for PT 2, 4, 7 and Draft BPC opinion on silver zeolite for PT 2, 4, 7 and Draft BPC opinion on silver copper zeolite for PT 2, 4, 7 and Draft BPC opinion on silver sodium hydrogen zirconium phosphate for PT 2, 4, 7 and 9 Wednesday 17 October: morning session Item Draft BPC opinions on silver (continued) Wednesday 17 October: afternoon session Item Draft BPC opinions on silver (continued) 5
6 Thursday 18 October: morning session Item 7.6 Item 8.1 Item 8.2 Item 8.3 Item 8.4 Revised Assessment Report following the submission of data after active substance approval: Formaldehyde for PT Margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide for PT octyl-isothiazol-3(2H)-one (OIT) for PT epsilon-momfluorothrin for PT Bacillus thuringiensis subsp. kurstaki, serotype 3a3b, strain ABTS-351for PT 18 Update on Union authorisation Draft BPC opinions on Union authorisation applications for a product family containing iodine / PVP-iodine Working procedure for applications for major change of a Union authorisation Union authorisation major change applications: cooperation during the evaluation stage Thursday 18 October: afternoon session Item 9.1 Item 10 Item 11 Draft BPC opinion on Questions on unresolved objections during mutual recognition of a PT 18 biocidal product family containing 1Rtrans phenothrin for use against ants AOB Action points and conclusions End of meeting o0o 6
4. Agreement of the minutes and review of actions from BPC Housekeeping issues For information
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