BIOCIDES 2016 19 TH ANNUAL CONFERENCE VIENNA, AUSTRIA A unique opportunity to join our expert panel for a two day event in Vienna which focuses on the latest information and advice on the application of the EU Biocidal Products Regulation (BPR) Seats Strictly Limited. Book now to avoid disappointment 30 NOVEMBER DECEMBER 01 TWO-DAY CONFERENCE, PRE- AND POST- CONFERENCE WORKSHOPS Brought to you by:
BIOCIDES 2016 19 TH ANNUAL CONFERENCE 30 NOVEMBER 01 DECEMBER, VIENNA, AUSTRIA About this event Regulators, authorities and biocides businesses are continuing to get to grips with the intricacies of the EU Biocidal Product Regulation - putting the provisions into practice and, where necessary, developing further explanation and understanding of the application of this hugely complex piece of legislation. As implementation progresses, more companies, across more industrial sectors, are feeling the effects and increasingly need to know their obligations if they are going to remain within the law. Companies also need to understand the likely impacts of the regulation on the supply of ingredients that are often critical to the performance of their products. The 2016 conference focuses on key aspects of Regulation (EU) No. 528/2012 concerning the approval of active substances and authorisation of biocidal products. Presentations include the latest developments from the European Commission and ECHA. As well as drilling down to the recent detail of this complex regulation, speakers will address topics such as efficacy testing of disinfectants, risk assessment, enforcement, EDCs and other borderline topics including MRLs, cosmetics and medical devices. The programme also includes some insight into the regulatory scene for biocides in the US, South Korea and Vietnam. Who should attend? Authorisation holders Registration holders National Competent Authorities Producers Retailers Formulators Consultants Other Stakeholders WHY ATTEND? EXPERT PANEL Listen to senior representatives from European institutions, regulators from Member States together with industry representatives from across the EU and elsewhere in the world! 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 a choice of 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 writing any questions you might have in respect of the biocides regime in advance of the conference. FOCUS Bring yourself up-to-date with the BPR since implementation and learn about developments in the rest of the world. FOCUSED WORKSHOPS Participate in one of the focused additional workshops to gain a more in-depth understanding of latest developments.
DAY 1: 30 November 2016 Chair: David Dillon, Senior Managing Scientist, Exponent International, UK 08:30 Coffee and Registration SESSION 1: Updates from the Authorities 09:00 Updates from the EU Commission In-situ product authorisation dossiers Special cases: ozones and free radicals Criteria for EDCs Criteria for Roadmap 2020 Martinus Nagtzaam, Policy officer, EU Commission, Belgium 09:30 Update on progress in the review programme of active substances Achievements of the Biocidal Products Committee and its Working Groups ECHA projects related to active substance approval Overview of progress regarding the efficacy of disinfectants and the new guidance for PT 1-4 and guidance being developed for PT 5, 11, 12, 14, 18 Kirsi Myöhänen, Scientific Officer, Biocides Assessment Unit, ECHA, Finland 09:55 Updates and future developments of R4BP 3 and SPC editor New features of the Biocides IT tools in 2016 Overview of items for future development Roberto Gilioli, Scientific Officer, Biocides Assessment Unit, ECHA, Finland 10:20 Q&A 10:35 Refreshments and networking SESSION 2: Experiences with Active Substance Approval 10:55 Chlorine-based biocides: Experiences from a decade of support Background to the actives, the consortia and activities to date Key milestones and challenges faced during the process Supporting an active product Meeting the data requirements Addressing (disinfection) by-products Learnings and future industry wish list Chris Howick, Product Regulation Manager, INOVYN Chlorvinyls Limited, UK 11:20 Rodenticides: experiences with authorisation renewal and harmonisation efforts Background Renewal of anticoagulant a.s. Public consultation of a.s. and comparative assessment of products Renewal of authorization of biocidal products Summary and conclusion Joergen Larsen, EU-coordinator, Danish EPA, Denmark 11:45 New active substances for treating articles: The adventure of Article 94 transitional measures Implications of regulating treated articles under the BPR New active substances coming into focus Downstream users take responsibility for approval of their hitherto unsupported active substances Time constraints with a view to the deadline 31 August 2016 (Article 94), particularly with respect to data gathering data and dossier preparing Affected products and potential consequence of non-approval Joint application by several downstream users Thomas Sendor, Manager Product Safety & Regulatory Compliance, Ramboll Environ Germany GmbH, Germany 12:10 Achieving and working with active substance approval for pt 21 Background to antifouling and PT21 Short background: I-Tech and Selektope The legal setting when most PT21 dossiers were developed BPD Risk assessment The evaluation process under BPD and BPR Changed data requirements Changed guidance BPD to BPR Outcome Approved for what Product approvals how Current status for PT21 actives and products in EU Harmonised chemical legislation in EU? Cecilia Ohlauson, Regulatory Affairs Manager, I-Tech AB, Sweden 12:35 In-situ active substance and experiences with applying for approval under the BPR Postantibiotic era, no new antibiotics in the next five years Surfaces in hospitals are ubiquitously contaminated by multiresistant micro-organisms Solution: Self-sanitizing surfaces, the answer against hospital acquired infections Problems with biocidal regulation Consequences of the problems with acceptance as in situ generated biocide J. Peter Guggenbichler, CEO, Amistec, Austria 13:00 Q&A 13:15 Lunch and networking SESSION 3: Risk Assessment 14:15 The future of pest management The impact so far from BPR Challenges ahead due to CLH classification The importance of professional pest controllers CEPA certified the new standard for pest management Dee Ward Thompson, Technical Manager, British Pest Control Association (BPCA), UK
Day 2: 1 December 2016 14:40 Guidance for the human and environmental risk assessment of disinfection by-products DBPs may pose risk to human health or the environment Overview of the steps taken to develop a harmonised approach to risk assessment Resulting guidance Challenges for future assessments Els Smit, Senior Scientific Advisor, National Institute for Public Health and the Environment, the Netherlands 15:05 A regulatory approach for mixture toxicity assessment Mixture toxicity and concepts for the assessment Authorisation procedure of biocides (active substances vs. products) Tiered approach for the mixture toxicity assessment of biocides as described in the Transitional Guidance on mixture toxicity assessment for biocidal products for the environment Anja Kehrer, Scientific Officer, Federal Environment Agency (UBA), Germany 15:30 Comparative risk assessment further developments Comparative risk assessment concepts for the assessment First experience from the product authorisation First results from a project sponsored by UBA: Development of criteria for a more quantitative comparative assessment for the environment Beatrice Schwarz-Schulz, Head of Subsection, Federal Environment Agency (UBA), Germany 15:55 Q&A 16:10 Refreshments and networking SESSION 4: EDCs 16:30 Development of criteria for the identification of EDCs: Outcome of the Berlin Workshop Draft Regulation proposed by the EU Commission Open points for discussion Vera Ritz, Head of Unit Steering and Overall Assessment Biocides, Federal Institute for Risk Assessment, Germany 16:55 Industry s Views on the Proposed EDC Criteria for Biocides Background to the criteria (industry views) Points of contention both from industry s point of view and other stakeholders: Why hazard characterisation is relevant? What we would like to see happen. Thoughts and experiences with REACH Peter Smith, Executive Director, European Chemical Industry Council Cefic aisbl, Belgium 17:20 NGO response to EDC criteria Scientific challenges Legal challenges Implementation challenges Giulia Carlini, Project Attorney, Environmental Health Program, Center for International Environmental Law (CIEL), Switzerland, 17:55 Q&A 18:15 Close of Day One 08:00 Registration SESSION 5: Borderline Topics 08:30 Overview of CLH process CLH process in general Specific considerations for biocidal active substances and BP Kirsi Myöhänen, Scientific Officer, Biocides Assessment Unit, ECHA, Finland 08:55 Assessing biocide residues in food Transfer of biocide residues into food Guidance documents for residue evaluation Dietary risk assessment approaches Kathrin Gottlob, Scientific Officer, Federal Institute for Risk Assessment, Germany 09:25 Residue levels in food is there chemistry between us? Aims of the food industry Safety versus good practice Problems and concerns The need for an holistic approach Iain Mortimer, Group Technical Manager, Apetito Ltd, UK 09:50 New EU Medical Device Regulation Changes ahead with the focus on disinfectants Key changes Product scope expansion Dual use Qualified person More stringent clinical evidence Rigorous post-market oversight Timeline How can you prepare? Stephan Solloch, Medical Devices and Pharma Applications, Lonza AG Regulatory Assurance Consumer Care EMEA, Switzerland 10:15 Q&A 10:30 Refreshments and networking SESSION 6: Other BPR Issues 10:50 Efficacy testing of disinfectants PT 1-5 Why efficacy matters why we need to assess efficacy Efficacy requirements for disinfectants what products have to achieve Design, selection and use of CEN and other efficacy test methods Linking test results, performance standards and label claims Mike Baldry, Regulatory Affairs Consultant, Antec International Ltd, UK 11:15 ebiozide is an IT-project of the Austrian CA is a systematic collection of data on biocidal products requests reporting directly into the database covers the amounts of products made available on the Austrian market per year processes annually reports from Authorisation holders enables assessments by the Austrian CA focusses on the quantities of active substances guarantees the confidentiality of the data has positive side effects: Austrian Biocidal Product Register
Pre-conference workshop application SPC to WORD available at the information desk (booth) of the Austrian Authority Maria Amon, Austrian Competent Authority for Biocides,Federal Ministry of Agriculture, Forestry, Environment and Water Management, Austria 11:40 SPC to Word & feedback from PBR IT meeting Gerhard Thanner, Austrian Competent Authority for Biocides, Federal Ministry of Agriculture, Forestry, Environment and Water Management, Austria 11.55 Will there be any effective preservatives left for paints? The use of preservatives in paints The sensitizer challenge The holistic approach why is it so important? What happened to innovation? Marian Rabone Johannesen, R&D Manager Biology, Jotun, Norway 12:20 Q&A 12:35 Lunch and networking SESSION 7: Enforcement 13:35 Enforcement of the BPR A view from the UK An Overview of the UK regime The Biocides Enforcement Group Mike Potts, HM Inspector of Health and Safety, Health & Safety Executive, Chemicals Regulation Directorate, UK 14:00 Enforcement of Article 95 provision Koen Van Maldegem, Partner, Field Fisher LLP, Belgium 14:25 Q&A 14:40 Refreshments and networking SESSION 8: An International Overview of Biocides Regulation 15:00 The management of biocidal products in Korea The lessons we learned from the humidifier disinfectant accident in Korea The relevant authorities related to biocidal products The management of biocidal products in K-REACH MOE's plan to legislate biocidal product regulation in Korea and its activities Sanghee Park, Manager, Chemtopia, South Korea 15:25 TSCA reform and the regulation of biocides in the US William McCormick, Research Fellow, Global Stewardship, The Clorox Company, USA 15:50 Vietnam Decree 91/2016/ND-CP (and other relevant regulations) on the management of chemicals, insecticides and disinfectants used in households and for health purposes Product notification/ registration requirements Labeling requirements Compliance deadlines Nhat Nguyen, Senior Regulatory Analyst, Asia Pacific, 3E Company/Verisk Analytics, USA 16.15 Q&A 16:30 Close of conference Workshop 1 Pre-conference, 29 November 2016, 09.00-17.00 Introduction to the BPR Morning Session Background and Introduction This session will introduce you to the core principles of the BPR, including active substances and biocidal products, product-types and treated articles. The information outlined will form the basis of the more advanced afternoon session and Workshop 2. The session will cover: Core principles of the Biocidal Products Regulation What is the BPR? What is a biocide active substances, biocidal products and treated articles defined Product-types, biocidal claims and functions Product decision tree: do you have a biocidal product or a treated article? Includes worked examples Introduction to associated obligations Active substance approval: submission of an application and understanding the status of ongoing applications Treated articles: labelling and communication Article 95: approved suppliers of active substances What is Article 95? How to understand if you are in compliance. Transitional measures: how to market your biocidal product during active substance evaluation Who is responsible and what do they do? Afternoon Session Product Authorisation Product Definition Recap (biocidal product vs. treated articles) How do you market your biocidal product? Introduction to product authorisation: what is it, who is involved and what are the timelines? Product authorisation types and conditions Annex II and Annex III of the BPR Understanding what data is required Data adaptations Data sharing What does the regulation say? Practical considerations How to prepare and submit and application the key points IT Tools (IUCLID 6, R4BP 3 and the SPC editor) (covered in more detail in Workshop 2)
Post-conference workshop Workshop 2 Post-Conference, 2 December 2016, 09.00-17.00 The BPR IT tools to submit your applications, Morning Session Background and Introduction The workshop will provide an introduction to the IT Tools (IUCLID 6, R4BP3 and SPC editor) you need to prepare and to submit your authorisation application. By building an interactive sample dossier, the workshop will cover all the steps you need to know for preparing and submitting your dossier. For the first hour of the workshop the trainer will give some background on the different IT tools to ensure all attendees are up to date on the latest developments. The trainer will then lead a group exercise to prepare a sample product authorisation dossier based on a dummy biocidal product. The details for this exercise will be provided to attendees on the day. There will be opportunities throughout the workshop to request further information and demos, where time permits, on the IT tools covered. The session will cover: Introduction to IUCLID 6 What is IUCLID and why are you required to use it? A bit of history: development of IUCLID and current state of play IUCLID 5 vs IUCLID 6: main changes and similarities Migration of IUCLID 5 to IUCLID 6 Practical considerations on installation of IUCLID 6 Expected future developments Introduction to R4BP 3 What is R4BP and why are you required to use it? What does R4BP look like? Setting up an ECHA account Expected future developments Introduction to the SPC Editor What is the SPC Editor and why are you required to use it? Information requirements Expected future developments Afternoon Session Interactive dossier build session Creating a biocidal product dossier in IUCLID 6 (assuming Union or National Product Authorisation Option) Dossier vs Substance or Mixture Database First use of IUCLID 6: setting up inventories, legal entities, user accounts and role management Importing documents:.i6z files Creating a substance database Completing substance identity information Entering endpoint data: (Robust) Study Summaries and Study Summaries Classification and labelling and other hazard data Section 13 Documents Linking to a mixture database Use of plug-ins Creating a dossier: Exporting and printing dossiers Creating an SPC From IUCLID Using the SPC Editor Submission of a product authorisation application via R4BP Dossier submission: Case Owner and Asset Owner Additional information Supporting documents Post-submission Monitoring your application (case) Responding to tasks Invoicing in R4BP The evaluation pipeline The workshops will be lead by: Siobhan Murphy, Senior Regulatory Scientist, The REACH Centre Ltd., UK Dr Rosalinda Gioia, Managing Regulatory Scientist, The REACH Centre Ltd., UK Our thanks to our exhibitors Reservations: https://chemicalwatch.com/biocides-2016 Email: orders@chemicalwatch.com Tel: +44(0)1743 818293
3 WAYS TO REGISTER 1 https://chemicalwatch.com/biocides-2016 2 3 orders@chemicalwatch.com +44(0)1743 818293 PRICES 30 NOVEMBER - 01 DECEMBER 2016 TWO-DAY CONFERENCE 895 +VAT (20%) PRE-CONFERENCE WORKSHOP 1 29 NOVEMBER 2016 545 +VAT (20%) POST-CONFERENCE WORKSHOP 2 2 DECEMBER 2016 545 +VAT (20%) Payment options: 1. Invoice payable by bank transfer, credit card or check made payable to CW Research Ltd 2. Online using our secure order-form Payment must be made before the event starts LOCATION & TIMINGS Austria Trend Hotels HOTEL SAVOYEN VIENNA Rennweg 16, 1030 Wien Tel: +43-1-20633-9105 Fax: +43-1-20633-9111 www.austria-trend.at/ Hotel-Savoyen-Vienna We have arranged a special bedroom rate for Conference participants at the Hotel Savoyen Vienna. Standard rooms = 130 Delegates will be sent a special link to make reservations directly with the hotel. EVENT TIMINGS: Tuesday 29 November 2016 Workshop 1 09:00-17:00 Wednesday 30 November 2016 Conference Day 1 08:30-18.15 Thursday 1 December 2016 Conference Day 2 08:00-16:30 Friday 2 December 2016 Workshop 2 09:30-17:00 Reservations: https://chemicalwatch.com/biocides-2016 Email: orders@chemicalwatch.com Tel: +44(0)1743 818293