BIOCIDES NOVEMBER, VIENNA. Why attend? About this event. Who should attend? biocides2013

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2 biocides2013 BIOCIDES NOVEMBER, VIENNA A unique opportunity to join our expert panel for a three-day event in Vienna at which we address legal issues and trade aspects of biocidal products, especially the challenge of transforming the regime from the Directive (BPD) to the Regulation (BPR). Seats strictly limited. Book now to avoid disappointment. About this event Why attend? The 2013 conference focuses on key aspects of the new Regulation (EU) No. 528/2012 concerning active substances and biocidal products. This includes the authorisation of biocidal products, and the core procedures for their application together with administrative and scientific assessment of these products. EXPERT PANEL Initial experience gained in the short period since adoption will be reviewed and the programme also includes valuable insight into the regulatory scene in the USA. The annual two-day Conference will be followed by two optional half-day Workshops on topics of key interest.the first Workshop offers a strategic view of the biocidal products market through to the end of the review programme in The second Workshop focuses on treated articles in relation to the BPR. Both the two-day Conference and the Workshops will give stakeholders insight into the current state of play of the Regulation. Listen to senior representatives from European Institutions, Regulators from Member States, together with industry representatives from across the EU CURRENT THINKING Gain valuable insight into the state of play of the BPR TIME EFFICIENCY Bring yourself up-to-date with the complex and changeable regulatory landscape concerning Biocides by attending two conference days and two workshops Q&A PANEL SESSIONS Have your specific questions answered by making use of the multiple Q&A sessions. Remember - you can send in any question you might have in respect of the Biocides regime in writing in advance of the conference Who should attend? FOCUS Registration holders Bring yourself up-to-date with the initial experience gained in the period since adoption National Competent Authorities FOCUSED WORKSHOPS Authorisation holders Producers Retailers Formulators Consultants Other stakeholders Participate in one or both of the halfday workshops to gain a more in-depth understanding of latest developments regarding treated articles and the review programme

3 CONFERENCE, DAY 1 (18 Nov.) 09:00 14:15 SESSION 1 14:45 10:00 Welcome 10:05 The New Regulation Applicable Since Speaker: European Institution 15:15 Union Authorisation Speaker: European Institution 15:40 First experience with the new tool. 16:30 11:45 17:10 Q&A Panel Discussion on Session One Nanomaterials How to apply the upcoming methods, criteria and assessment of relevant data to nanomaterials as defined in the BPR. Lunch & networking 17:35 National Authorisation Procedures Micro-Organism Assessment/Authorisation Micro-organisms as active substance or biocidal product their assessment and their authorisation respectively under BPR. 18:00 Q&A Panel Discussion on Session Four Authorisation Renewal Renewal of an authorisation granted under BPD subject to mutual recognition in accordance with art 31 & 40 BPR (with and without comparative assessment). 13:50 Biocidal Product Families The 3 national authorisation procedures according to the BPR (first authorisation, mutual recognition in sequence/ in parallel) and details (data requirements, time-lines, format, decision process, fees). 13:25 Biocidal Product families instead of frame formulation the right step forward? SESSION 2 13:00 Q&A Panel Discussion on Session Three SESSION 4 Speaker: European Institution 11:30 IUCLID :45 The procedure of an union authorisation from application to final decission a view from ECHA R4BP 3.0 New features and processing IUCLID 5.6 data implementation. 16:05 Approvals/Renewals The process of approval as well as the process of renewal of an approval of an active substance in view of the new regime (approval of active substances instead of their inclusion in Annex I/IA/IB) 11:05 SESSION 3 Hear about EU-wide priorities, investigations and update on the latest developments; Status of the upcoming amendments to the BPR, especially the Art 93, 94 and 95; How to cope with the provisions in case an active substance or a biocidal product not covered so far due to definition, wrong PT, misleading information or newly addressed; Progress made regarding the 42 tasks to be fulfilled (27 of them by the commission); 10:40 Q&A Panel Discussion on Session Two 18:15 PAR & SPC Under BPR Product Assessment Report (PAR) and harmonised Summary of Biocidal Product Characteristics (SPC) for single biocidal products or biocidal product families as part of an authorisation under the BPR (format, content, language). Q&A Panel Discussion on all topics of interest relating to the BPR 19:00 End of Day 1

4 CONFERENCE, DAY 2 (19 Nov.) 8:30 14:25 OECD's E-Chem-Portal - how to use and what to gain for biocides. SESSION 5 9:00 Speaker: International Organisation 14:50 Cumulative and Synergistic Effects Speaker: Member State Institution Speaker: International Organisation 15:15 Risk Envelope 9:50 15:40 Borderline Cases Borderline cases respectively dual use for products covered by Art. 2 Para 2 lit a-k of the BPR. Poison Information Database The poison information database acc Art 45 of the CLP regulation and how will it affect biocidal products. Risk envelope approach applicable for the authorisation of biocidal product families? thoughts. OECD Update OECD - Overview and update on current work relevant for biocides. Cumulative and synergistic effects to be taken into account during the authorisation of a biocidal product acc. to Art 19 para.2 lit d+e BPR. 9:25 E-Chem-Portal 16:10 Q&A Panel Discussion on Session Seven 10:15 10:30 Q&A Panel Discussion on Session Five 16:25 SESSION 6 11:00 A Court Decision The Söll- case (Court decision C 420/10, 2012) and the consequences for actives substances newly covered by the regime. Speaker: Law Firm 11:25 Q&A Panel Discussion on all topics of interest regarding the present and future enforcement of biocides regulations Comparative Assessments The comparative assessment of biocidal products in view of industry corner stones and burden of proof. 17:30 End of Day 2 Please note: Speakers will be senior representatives from European Institutions, National Competent Authorities together with representatives from industry across the EU. Speaker names will be announced in due course. 11:50 Treated Articles Overview on Treated articles - a brief update. Green Commitment: The conference is organised with a strong focus on the priciples of "Green Meeting" 12:15 12:30 Q&A Panel Discussion on Session Six Lunch & networking SESSION 7 14:00 Anti-Microbials Regulation in the USA The new draft on anti-microbials in the USA amended rules.

5 WEDNESDAYDAY 09 OCTOBER WORKSHOP, 3 (20 Nov.) 09:00-12:00 WORKSHOP ONE: VISION FOR :30-16:00 WORKSHOP TWO: TREATED ARTICLES 08:30 12:30 09:00 Workshop: Vision for Strategic Debate on the Impact of the BPR Regime Until the End of the Review Programme 13:00 Overview What impact will the BPR have on: The number of authorised products, their volumes or, in general, on changes to the national/eu markets The economic development of the EU, especially with regard to SMEs Incidences of resistance to biocidal products developed, environmental effects (adverse), cases of poisoning incidents and regarding occupational diseases The level of innovation and the creation of green jobs The number of active substances sustaining on the national/eu market, how many biocidal products will stay or be available (as real products or just family spin offs) How the required record keeping will affect the daily work of authorisation holders of biocidal products and how it will enforce compliance. Views/statements will be given by panelists; being Representatives from the European Parliament, the European Commission, National Competent Authorities, Industry and NGOs. These will subsequently be discussed with the audience. Treated articles in view of the BPR. Key issues to get the concept working (definitions, function/property, primary biocidal function substance/mixtures/articles, biocidal/ non-biocidal, sector specific labelling). 13:30 Labelling, information obligations and documentation requirements by manufacturers and suppliers (Art 58, 65, 66 BPR). 14:00 14:30 Efficiency How to prove that articles are treated with biocidal products or incorporate biocidal products in a sufficiently effective way. Speaker: Member State Institution 14:50 Guidance Guidance available for Treated Articles from experience with the BPD, from other sources such as Nordic Countries or US or coming up on the basis of the BPR. Morning Q&A Panel Discussion 12:00 Labelling, etc. 15:10 Afternoon Q&A Panel Discussion End of morning workshop 16:00 End of afternoon workshop Please note: Speakers will be senior representatives from European Institutions, National Competent Authorities together with representatives from industry across the EU. Speaker names will be announced in due course. HOW TO REACH THE VENUE From Airport Vienna: Commuter railway system S7 or CAT (CityAirportTrain) Wien Mitte metro U4 Schönbrunn (8min walk) or: Commuter railway S7 or CAT Wien Mitte metro U4 Hietzing tramway 10 get off at Penzingerstraße (3min walk). From Westbahnhof: Tramway 52 or 58 get off at Penzingerstraße find the hotel on the right side of Schlossallee (3min walk)

6 3 WAYS TO REGISTER orders@europeanbiocides.net PRICES (EXCLUDES WORKSHOPS) VAT FULLNOVEMBER 3 DAYS (18,19 & 20 NOVEMBER - INC. BOTH WORKSHOPS) Payment options: CHEMICAL WATCH SUBSCRIBERS - 50 discount on full 3-day rate, below 1. Invoice payable by bank transfer, credit card or chaque made payable to CW Research Ltd. ADDITIONAL DELEGATE PLACES qualify for a 10% reduction 2. Online using our secure order-form HALF-DAY WORKSHOP (20 NOVEMBER - PRICE PER WORKSHOP) FULL 3 DAYS (18,19 & 20 NOVEMBER - INC. BOTH WORKSHOPS) VAT VAT Payment must be made before the event starts LOCATION & TIMINGS AUSTRIA TREND HOTEL EVENT TIMINGS: Park Royal Palace Vienna Schlossallee 8, 1140 Vienna, Austria Monday 18 November: 09:00-19:00 Reservations: Tel.: +43 (1) Web: Wednesday 20 November: Morning Workshop: 08:30-12:00 Afternoon Workshop: 12:30-16:00 Tuesday 19 November: 08:30-17:30 CAN'T ATTEND? PRE-ORDER THE VIDEOS If you are unable to attend the live event itself, why not pre-order a copy of the high quality video recordings being made of this event? Delivered online, in MP4 format. Simply place your order for the recordings using the booking methods above. VIDEO DOWNLOAD: FULL 2 DAYS VAT