The 7th Symposium focusing on authorisation of biocidal products and active substance approval within the Biocidal Product Regulation
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1 BIOCIDES SYMPOSIUM '16 BUDAPEST, HUNGARY The 7th Symposium focusing on authorisation of biocidal products and active substance approval within the Biocidal Product Regulation Seats strictly limited. Book now to avoid disappointment! NEW WOR KS ADD HOPS ED 12 M ON AY MAY 2016 TWO DAY CONFERENCE Brought to you by:
2 BIOCIDES SYMPOSIUM MAY BUDAPEST, HUNGARY About this event A symposium focusing on authorisation of biocidal products and active substance approval within the Biocidal Product Regulation This two-day symposium will focus on Regulation (EU) No 528/2012 and will provide an in-depth examination of the various product authorisation processes foreseen within the regulation. It will include presentations on applications for union authorisation together with authorisation of product families and presentations from the European Chemicals Agency, Member State Authorities and industry. Other key issues to be addressed within the symposium: Mutual recognition Product families Classification & labelling and SDS of biocidal products Private labelling Endocrine disruptors Active substance approval under the BPR The work of the ECHA Board of Appeal Recent data sharing appeals Enforcement experiences in Hungary and Austria Risk assessment Who should attend? Representatives of authorisation/registration holders, national competent authorities as well as other involved stakeholders (producers, retailers, formulators, consultants, etc.) dealing with these issues WHY ATTEND? EXPERT PANEL Listen to senior representatives from European institutions, regulators from member states, together with industry representatives and service providers from across the EU. CURRENT THINKING Gain valuable insight into the current state of BPR product authorisation and active substance approval. TIME EFFICIENCY Bring yourself completely up-to-date with the complex and changeable landscape of Biocides Product Authorisation by attending two conference days. 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 Biocides Product Authorisation and Active Substance Approval in writing in advance of the Symposium. FOCUS Bring yourself up to date on the various implementation activities relevant to product authorisation under the BPR.
3 DAY 1: Tuesday 10th May :00 Registration and Coffee 09:30 Welcome SESSION 1: Update from the regulators 09:40 ECHA update: recent developments and future perspectives ECHA activities: overall update IT tools: on-going work and further progress Union authorisation: achievements and future outlook Article 95: current status and next steps Chiara Pecorini, Scientific Officer, Biocides Assessment Unit, ECHA 10:10 Q&A Panel Session SESSION 2: Product authorisation 10:20 Union authorisation Member State viewpoint NL experiences and cost Marcel Hulsman, Account Manager Biocides, Board for the Authorisation of Plant Protection Products and Biocides, The Netherlands Austrian experience and cost Maria Amon, Waste Management, Chemicals Policy and Green Technology Division, V/5, Chemicals Policy and Biocides, Federal Ministry, Forestry, Environment and Water Management Austria 10:45 Same biocidal product authorisation Maria Amon, Waste Management, Chemicals Policy and Green Technology Division, V/5, Chemicals Policy and Biocides, Federal Ministry, Forestry, Environment and Water Management Austria 11:00 Q&A Panel Session 11:10 Refreshments and networking 11:30 Case Study Union Authorisation Gosia Oledska, Ecolab, Belgium 11:55 The Mutual Recognition Agreement (MRA) on biocidal products between the EU and Switzerland Historical background Swiss ordinance on biocides and BPR What is covered by the MRA (and what not)? What does the MRA mean in practice for companies in EU and CH? Organisation of the Swiss competent authority How a granted Union Authorisation is taken over in Switzerland Application of Art. 95 BPR Experiences made in mutual recognition since 2010 Brunhilde Kolp Buchs, Scientific Officer at the Swiss Federal Office of Public Health, Switzerland 12:20 Mutual recognition from a competent authority point of view Experiences with mutual recognition Referrals according to 35 Biocides Regulation Suggestions for a smoother performance Ev Kretschmar, Federal Institute for Risk Assessment, Germany 12:45 Q&A Panel Session 13:00 Lunch and networking 14:00 Biocidal Product Families (1) Marcel Hulsman, Account Manager Biocides, Board for the Authorisation of Plant Protection Products and Biocides, The Netherlands 14:25 Biocidal Product Families (2) case study Isabelle Demoment, Regulatory Manager, HYPRED SA, France 14:50 Biocidal Product authorisation in Consortia, including BPF The experience we have gained with consortia on product level Reasons to join a consortium Cost saving aspect Advantages & disadvantages of working together The use of the BPF concept in a consortium Dossier preparation in a consortium Dossier submission options in a consortium Tineke Dewilde, Senior Project Scientist, ARCHE, Belgium 15:15 Q&A Panel Session 15:30 Refreshments and networking SESSION 3: Other important developments 15:50 Classification & labelling and SDS of biocidal products how to handle the changes for BP Main classification and labelling requirements Link to CLP and REACH Main challenges (national/union authorisation) Changes in classification and labelling: key consideration Christian Gruendling, Technical Director, FCIO, Austria 16:15 Cooperation and cost sharing private labelling under the BPR Private labeling a practical solution to reduce costs and administrative efforts Definition of different possible models for private labelling under the BPR Highlight on potential problems and dangers Guidance on how to choose the best option Henning Krueger, JUR Solution LLP, Germany
4 16:40 What does the deadline 1 September 2016 mean for the regulatory compliance of treated articles intended for food contact applications? Anna Gergely, Director EHS Regulatory, Steptoe & Johnson LLP, Belgium 17:05 Identification and regulation of endocrine-disrupting biocides state of the implementation and its controversial policy debate Endocrine disruptors a global threat The legal provisions on endocrine-disrupting biocides according to BPR exclusion and derogation The process of the implementation of endocrine-disrupting criteria under severe criticism Current impact assessment economy or science? Recommendations from an NGO point of view Susanne Smolka, Senior Policy Advisor (Biocides / Pesticides), PAN, Germany 17:30 Q&A Panel Session 17:45 Close of Day One/Cocktails 09:50 agpure nanosilver, a nanostructured biocide: technology, nanosafety and regulatory background Introduction antimicrobial nanosilver Nanosilver technology and products Benefits of using nanosilver Regulatory background (EU-BPR, nanospecific data) Nanosafety: projects and results Gregor Schneider, Head of Business Development (Biologist), RAS AG, Germany 10:15 Iodine active substance case study: Impact of the BPR for an SME Status before REACH and BPR Impact of the transitional period Impact of BPR Peter Hamerli, Managing Director, Alkimia, Hungary & Agnes Botos, REACH, GHS & Biocide consultant, Hungary 10:40 Q&A Panel Session 10:55 Refreshments and networking Session 5: The ECHA Board of Appeal DAY 2: Weds 11th May :30 Registration and Coffee SESSION 4 : Active substance approval under the BPR 09:00 Update on the review programme of active substances Achievements of the Biocidal Products Committee and its Working Groups New Review Programme Regulation ECHA projects related to active substance approval Kirsi Myöhänen, Scientific Officer, ECHA 09:25 Supplying in-situ generated substances, experience from the submission of the Active Chlorine generated from Sodium Chloride by Electrolysis Dossier Definition of the active Article 95 requirements Working with the Evaluating CA Risk Assessment Preparation Co-operation with data owners of related dossiers Data Sharing Do s and Don ts Nick Meakin, CEO, Aqualution Systems Ltd, UK 11:15 The work of the ECHA Board of Appeal (BoA) An outline of the appeal process BoA decisions under the BPR to date Pending appeals to the BoA under the BPR Andrew Fasey, Technically Qualified Member of the Board of Appeal, European Chemicals Agency, Finland 11:40 A review of recent data sharing appeals Darren Abrahams, Steptoe & Johnson LLP, Belgium Session 6: Enforcement 12:05 Member State co-operation in enforcement activities Eugen Anwander, Senior scientific officer, Austrian Institute for Environment and Food Safety, Vorarlberg State Service, Austria 12:30 Q&A Panel Session 12:45 Lunch and networking 13:45 MEGB current activity MEGB activity and its evolution since the beginning MEGB interface and dialogue with industry MEGB: harmonized views for biocidal products authorization? Maristella Rubbiani, Head of Unit, Istituto Superiore di Sanità Roma, Italia
5 DAY 2: Weds 11th May :10 Preparations for checking compliance with Article 95 in Hungary Enforcement control in Hungary Raising public awareness regarding compliance with Article 95 Nation-wide training for the chemical safety inspectors on how to check compliance with Article 95 Further steps Emese Szanto, EU-coordinator, biocidal products, Hungarian Biocide Competent Authority Office of the Chief Medical Officer of State, Hungary 14:35 Practical insights from experiences with biocides inspections for SMEs in Austria Eugen Anwander, Senior scientific officer, Austrian Institute for Environment and Food Safety, Vorarlberg State Service, Austria 15:00 Article 95 Burden or Reward? Background on article 95 Industry obligations How Bayer approached them Difficulties encountered Questions for future handling A proposal to ease the process and the enforcement in future Elmar Rump, Regulatory Affairs, Bayer, France 15:25 Q&A Panel Session 15:40 Refreshments and networking Session 7: Risk Assessment 16:00 Environmental risk assessment Environmental Risk Assessment (ERA) general overview Hazard assessment determination of PNECs: end points and assessment factors Exposure assessment calculation of PECs: emission scenarios and models Refinement challenges Karen Howard, Head of Biocides (Europe), Exponent International Ltd, UK 16:25 Human health risk assessment under BPR Principles of human health risk assessment Approaches to dietary risk assessment Approaches to animal safety assessment Sven Ruhl, Project manager, Dr Knoell GmbH, Germany 16:50 Q&A Panel Session Close 2 HALF DAY WORKSHOPS on 12th May 2016: AM 09:00 12:30 Planning a biocidal product family authorisation Topics to be covered: Part 1: How to set up a product family and considerations for authorisation This session will include interactive exercises putting into practice the concepts and rules for BPF formation and structuring a test programme around a family. Considerations for forming a biocidal product family (BPF) and the use of meta SPC What to include in the family and when; future proofing? Justifying a BPF product grouping Interactive exercise: defining a BPF Determination of a test programme Interactive exercise: proposing a test programme Part 2: Preparing a dossier and SPC for a BPF dossier Attendees with access to IUCLID may wish to follow the examples presented in this session. Using IUCLID for biocides and how to handle BPF within IUCLID. Creating an SPC and using the SPC template for a BPF with me-ta-spc. Sara Kirkham, Senior Consultant, CEHTRA UK and Carlo Poncipe, Senior Consultant, CEHTRA UK PM 13:00 16:30 Building a successful product dossier using the right data This workshop will aim to provide you with the practical tools to build a successful product dossier. We will provide you with advice on avoiding the many potential pitfalls that exist. The workshop aims to cover the following topics and will have an interactive element. Planning, Scheduling and communications Data gap analysis including the assessment of data quality Strategic use of Biocidal Product Families (as appropriate); inc. sub-families (meta) and data considerations Data waiving possibilities Data generation How to make best use of data in risk assessment, consideration of available models, tips on possible refinement of models IUCLID overview of key sections and tips on how to approach the dossier preparation Product Assessment Report (PAR) key considerations Product label, SDS and generation of the SPC Karen Howard, Head of Biocides (Europe), Exponent International Limited, UK and Alison McGuire, Senior Managing Scientist Regulatory (Biocides), Exponent International Limited, UK
6 3 WAYS TO REGISTER orders@chemicalwatch.com +44(0) PRICES MAY TWO-DAY SYMPOSIUM 850 +VAT (27%) (Early bird price if booked before 29 February 2016) TWO-DAY SYMPOSIUM 895 +VAT (27%) (Standard price if booked on/after 29 February 2016) 12 MAY WORKSHOPS 275 +VAT (27%) each Payment options: 1. Invoice payable by bank transfer, credit card or check made payable to CW Research LLC. 2. Online using our secure order-form Payment must be made before the Symposium starts LOCATION & TIMINGS SOFITEL BUDAPEST CHAIN BRIDGE Szechenyl Istvan Ter 2 Budapest, Hungary Tel: +36(06) EVENT TIMINGS: Tuesday 10 May :00 17:45 Wednesday 11 May : Thursday 12 May Workshops AM PM Reservations: orders@chemicalwatch.com Tel: +44(0)
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