CHEMICAL WATCH GLOBAL ENFORCEMENT SUMMIT 2015

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CHEMICAL WATCH GLOBAL ENFORCEMENT SUMMIT 2015 NEW FOR 2015 LE CHATELAIN BOUTIQUE HOTEL, BRUSSELS A unique opportunity to join our panels: twenty-one+ experts including EU and Member State officials, regulatory managers from industry and professional advisers as they share special perspectives and understanding of both European and global regulatory enforcement challenges in a relaxed, informal environment. TWO-DAY SUMMIT 20 21 22 OCTOBER

Global Enforcement Summit: 20-22 October 2014, Brussels NEW FOR 2015 CHEMICAL WATCH GLOBAL ENFORCEMENT SUMMIT 2015 20-22 OCTOBER 2015, BRUSSELS About this event An opportunity to participate in one of two pre-summit workshops scheduled or 20th October 2015. DAY 1: REACH AND CLP ENFORCEMENT Day one offers a holistic review of the REACH/CLP enforcement agenda - reviewing progress towards harmonized enforcement and exploring the very real need for standardisation across EU Member States, including restrictions and SVHCs. DAY 2: GLOBAL ENFORCEMENT OF CHEMICAL REGULATIONS Against a complex and changeable regulatory landscape, Day Two of the Summit brings together a panel of global regulatory experts, ready to answer your questions about the enforcement challenges facing industry today. Using a mixed format of presentations and in-depth Q&A panel discussions, the programme tackles enforcement issues around the world, including the EU, China, Taiwan, South Korea, Asean, Russia and the USA Who should attend? Heads of Regulatory Affairs/ Regulatory Managers Compliance Officers EHS Directors/Managers Government Regulators Product Registration Managers Toxicologists Risk Assessment Managers Lawyers Why attend? EXPERT SPEAKERS ON HAND Listen to senior representatives from regulators from across the EU, including Austria, Sweden, The UK, Germany, and Italy LATEST, JOINED-UP THINKING Get to know the latest thinking on harmonised enforcement of REACH and CLP from both sides of the discussion - those of industry and enforcers DETAILED UPDATE ON ASIA AND THE REST OF THE WORLD Bring yourself up-to-date with the complex and changeable enforcement landscape in S E Asia, Russia, and the USA TIME EFFICIENCY Gain a comprehensive update of the complex and changeable landscape of enforcement of chemical regulation around the world in just two days FOCUS Meet the experts and bring yourself up-to-date with the latest thinking across a wide range of jurisdictions Q&A PANEL SESSIONS Have your specific questions answers by making use of the multiple Q&A sessions. Remember, you can send in any questions you might have in writing in advance of the Summit.

Day 1: Enforcement of Reach & CLP DAY 1 (14 Oct): Enforcement of Reach & CLP DAY 1: WEDNESDAY 21 OCTOBER DAY 1 Enforcement of Reach & CLP 08:30 Registration 09:00 Keynote Eugen Anwander, Austrian Institute for environment and food safety, Austria SESSION 1 COMPLIANCE CHECK DECISIONS AND RESTRICTIONS 09:15 Follow-up to dossier evaluation and enforcement of evaluation decisions: current experience and challenges the follow-up process within ECHA some statistics on the cases handled under the follow-up process co-operation with the Member States for enforcement of evaluation decisions Ofelia Bercaru, Head of Unit, Directorate of Evaluation, ECHA, Finland 09:40 Restrictions: Experiences with adoption of new restrictions, whole process Practical enforceability of restrictions Feedback from enforcer to ECHA Benefits of enforcer involvement in legislative development Richard Hawkins, UK Environment Agency, UK 10:05 UK view of enforcing Restrictions: Who Enforces what? HSE, Case studies EA, Case Studies LA, Future Plans and EU level activity Mike Potts, HSE, UK 10:30 Enforceability of restrictions: tools and challenges Key elements to be considered when assessing the enforceability of a new restriction Challenges for enforcers Analytical methods: ECHA Forum s project on recommending analytical methods to check compliance with REACH Annex XVII restrictions Other supporting tools under development Maria Letizia Polci, Ministry of Health, Italy 10:55 Q&A Session 11:15 Refreshments and networking SESSION 2 FORUM: RECENT ENFORCEMENT DEVELOPMENTS INCLUDING PILOT PROJECTS 11:30 Authorisation from a Member State s perspective Practical considerations about authorisation decisions What DUs need to observe Enforcement impact Eugen Anwander 11:55 The Market Surveillance Approach Speaker to be confirmed 12:20 Learning from REF-3 projects related to ORs2) ORO the Only Representative Organisation, Fact and Figures (Brussels) The role of the OR under REACH OROs Best Practice Guide REF-3 Feedback on OR Inspections Guidance for Importers and non-eu Manufacturers Dieter Drohman, ORO President, Belgium 12:45 Q&A Session 13.00 Lunch SESSION 3 SVHCS IN ARTICLES 14:00 SVHCs in articles experience from enforcement in Sweden The Swedish Chemicals Agency responsibilities and mandate in enforcement of articles What do we want to achieve with our enforcement activities Experiences from enforcement activities Future work Mats Forkman, Head of unit Enforcement and Registries, Swedish Chemicals Agency, Sweden 14:25 REACH requirements on SVHC in articles a downstream user perspective Orgalime industries: what s the role of a second level downstream user and article manufacturer? Challenges and complexities of articles 7 and 33 in practice Impacts of complex, global supply chains and how to cope with them Gathering, storing, communicating meaningful information on SVHC in articles Robert van Beek, Chair of Orgalime Task Force Substances, Belgium

Day 1: Enforcement of Reach & CLP Day 2: Global Enforcement of Chemicals Regulation Day 1 (cont), DAY 2 (15 Oct): Emerging Regulatory Challenges around the World DAY 2: THURSDAY 22 OCTOBER 14.50 The lack of compliance/ enforcement of SVHC in articles notification and the right to know Tatiana Santos, Senior policy officer - Chemicals and nanotechnology, European Environment Bureau, Belgium 15:15 Q&A Session 15:20 Refreshments and networking SESSION 4 CASE STUDY 1 ON CHEMICAL REGULATORY COMPLIANCE GLOBALLY, INCLUDING MANAGEMENT STRUCTURES, IT SYSTEMS, ETC 15:45 The Electronics sector Hans Wendschlag, Environmental Manager, Hewlett Packard, Sweden 16:10 Regulatory Compliance in the Global Outdoor, Sport, and Fashion Apparel Industry Overview of OIA and the OIA Chemicals Management Working Group, and partnership with the Zero Discharge of Hazardous Chemicals group and the Sustainable Apparel Coalition 16:35 Key Chemicals Management Tools in use in the apparel industry (i.e. Higg Index Chemicals Management Module, ZDHC Audit Protocol) - these identify industry best practices along a spectrum from basic compliance to leading practice (green chemistry and innovation) Industry advantages and challenges around regulatory compliance Beth Jensen, Director of Corporate Responsibility, Outdoor Industry Association (OIA), USA SESSION 5 ROUNDTABLE DISCUSSION: HOW TO CREATE A MORE LEVEL PLAYING FIELD FOR COMPANIES IN EU! 17:20 Close of Day One DAY 2 Global Enforcement of Chemicals Regulation SESSION 6 COMPLIANCE CHECK DECISIONS AND RESTRICTIONS 09:00 Enforcement of Chemicals Regulation in China Updates of chemical regulation in China; Enforcement of chemical regulation (MEP Order 22, Decree 591, etc); Practical Advice for chemical industries Eric Xiong, CIRS, China 09:25 Enforcement of Chemicals Regulation in Taiwan Updates of chemical regulation in Taiwan; Enforcement of chemical regulation (TCSCA, OSHA, etc); Practical Advice for chemical industries Eric Xiong 09:50 The Implementation and Enforcement of GHS in China A timeline of GHS implementation in China GHS relevant law and standards in China A comparison between GB and CLP Enforcement and penalties Specific requirements for SDS/label for HazChem registration How to comply with China GHS Cloris Pan, CIRS, China 10:15 Q&A Session 10:30 Refreshments and networking 10:45 The Enforcement of Chemicals Regulation in South Korea Low volume registration (<1ton) based on actual practice Polymer of low concern based on actual practice Interim measures from TCCA to K-REACH Interpretation of Q&A published on April 10 by the Authority Ami Fukuroi, Senior Researcher, Chemicals & Environment & Safety Division, KTR, South Koreaes 11:10 Enforcement in other ASEAN countries Update of chemical regulations in the ASEAN region GHS status in the ASEAN region Experiences with enforcement of chemical legislations in these countries Deirdre Lawler, Head of Industrial Chemicals & Biocides - Regulatory Affairs, Dr. Knoell Consult GmbH, Germany 11:35 Q&A Session SESSION 7 FORUM: RECENT ENFORCEMENT DEVELOPMENTS INCLUDING PILOT PROJECTS

Day 2: Global Enforcement of Chemicals Regulation Day 1 (cont), DAY 2 (15 Oct): Emerging Regulatory Challenges around the World 11:50 Taking Action on Toxics and Chemical Safety: Meeting the Challenge of Enforcing the Toxics Substances Control Act Implement next generation enforcement Focus on risk Monitor imports for compliance Encourage self-audits Include projects with an environmental or public health benefit Develop significant cases Rosemarie Kelley, Acting Deputy Director, Office of Civil Enforcement, Office of Enforcement and Compliance Assurance, U.S. Environmental Protection Agency, USA 12:15 Enforcement aspects of the current chemical legislation in the Russian Federation Russian chemical regulatory framework: main characteristics and specifics Enforcement authorities: structure and responsibilities Enforcement process Current challenges and future prospects Emilia Vassileva, Regulatory Research Analyst Central and Eastern Europe, 3E Company, USA 12:40 Q&A Session 13.00 Lunch SESSION 8 CASE STUDY 2 ON CHEMICAL REGULATORY COMPLI- ANCE GLOBALLY, EG MANAGEMENT STRUCTURES, IT SYSTEMS, ETC 14:00 The Automotive sector Chemical Compliance A Challenge not only for the global automotive industry Existing tools and processes in the automotive Industry Where are the weak points? Current initiatives in the automotive sector for further improvement Our expectations of legislators and other sectors Timo Unger, Manager, Environmental Affairs, Hyundai Motor Europe, Germany SESSION 9 OTHER AREAS OF ENFORCEMENT: 14:25 Enforcement of regulations for biocides perspectives from an EU Member State The Swedish Chemicals Agency responsibilities and mandate in enforcement of regulations for biocides The Biocidal Product regulation from our perspective as authority responsible for enforcement Cooperation with Customs Experiences from enforcement activities treated articles, proactive and reactive controls How do we cooperate in the EU and can we do it better Mats Forkman, Head of unit Enforcement and Registries, Swedish Chemicals Agency, Sweden 14:50 Making a Difference: Ensuring Compliance with U.S. Antimicrobial Pesticide Regulations How next generation compliance efforts affect pesticides enforcement How USEPA decides which pesticide cases to develop How USEPA monitors pesticide imports for compliance What USEPA does to encourage self-auditing and disclosures Rosemarie Kelley, Acting Deputy Director, Office of Civil Enforcement, Office of Enforcement and Compliance Assurance, U.S. Environmental Protection Agency, USA 15:15 Q&A Session 15:30 Refreshments and networking 15:45 Nanomaterials in EU regulation Nanomaterials as any other chemicals - application of EU regulation on chemicals to nanomaterials Existing and planned provisions specific to nanomaterials Implementation and enforcement - first experience and ongoing activities Helene Kanellopoulos, DG Environment,EU Commission, Belgium 16:10 The political framework for nanomaterials in the EU a field for better regulation? More than 10 years of safety research for nanomaterials what do we know about their safety Overview over existing regulation for nanomaterials in the EU and member states and its pitfalls How to shape a political framework for nanomaterials in Europe that appropriately addresses possible risks and leaves room for innovation Dr Carolin Kranz, Senior Manager, Communications & Government Relations BASF Group, Nanotechnology, Germany 16:35 Civil Society Perspective on 6 years of nano policy and regulations: How were the existing EU regulations adapted and enforced in relation to nanomaterials, 16:35 For what results? What have the respective roles of stakeholders been in this process? What should the next steps be? David Azoulay, Managing Attorney, CIEL, Switzerland SESSION 10 PANEL DISCUSSION SESSION 17:45 Close of Summit

Optional One-Day Workshops Day 1 (cont), DAY 2 (15 Oct): Emerging Regulatory Challenges around the World TUESDAY 20 OCTOBER WORKSHOP 1 Preparation for Inspection under REACH After 7 years the REACH regulation is firmly established as the cornerstone of safe management and use of chemicals within the EU. The various protocols of the regulation are all now active and are impacting on virtually all industry sectors and business activities from manufacture to retail. With regulation comes enforcement and inspection and lots of questions: - who are the regulators? is each Member State the same? how is enforcement co-ordinated? what is the focus of inspections? and what are the penalties for non-compliance? Using a mixture of presentations, discussions and exercises this workshop will answer all these but more importantly it will provide attendees with the information they need to ensure that they can manage inspection with confidence and, just as importantly, what action is needed to embed REACH compliance into the company management and ethos. 0900 Coffee and Registration 0930-1700 SESSION 1 INTRODUCTION TO ENFORCEMENT The European Chemicals Agency is charged with managing REACH across the EU but each Member State (MS) has legislated for enforcement and penalties. It is important to understand who is responsible for what and how enforcement is co-ordinated across all MS Roles & responsibilities of regulators ECHA MSCA (Member State Competent Authority) Customs MS variations Co-ordination between regulators The Forum MSCA reporting Joint enforcement projects Inspection targets and strategies Penalties & prosecutions SESSION 2 INSPECTIONS Inspections may be initiated for a range of reasons and understanding the reasons helps provide focus for the preparation Triggers for inspection Focus of inspections Regional and industrial sector variations Non-regulatory inspections SESSION 3 KEY AREAS OF INTEREST TO INSPECTORS: Inspectors may look at any aspect of the regulation they chose but the focus is likely be driven by company activity, its track record and aspects most likely to impact on safe chemical use. However a number of key areas can be identified Preregistration and registration status & documentation Exemptions from registration SDS & e-sds management Generation of SDS Implementation of SDS Supply chain management SVHC management Authorisation and Restrictions CLP compliance SESSION 4 SUCCESSFUL INSPECTION: Good preparation is the key to a successful inspection and this starts with a commitment to compliance and an ability to demonstrate that commitment Management company policy defined roles & responsibilities management procedures training record keeping integration internal audit review Preparation who is requesting the inspection scope & focus of inspection review of previous inspection identification of any weaknesses collation and management of documentation briefing of staff Workshop Leaders: Simon Brearley, Senior Regulatory Consultant, The Reach Centre, UK Tarn Brown, Regulatory Consultant, The Reach Centre, UK

Day 1 (cont), DAY 2 (15 Oct): Emerging Regulatory Challenges around the World WORKSHOP 2 GHS IMPLEMENTATION - A PRACTICAL GUIDE GHS, Globally Harmonized System, is a system for classification, labelling and packaging of chemicals. It was adopted by the UN in 2001, and it is the aim that all countries worldwide should implement the system in order to insure uniform methods for evaluation and communication of hazards. In the EU, GHS was implemented in January 2009. The EU implementation is called CLP, Classification, Labelling and Packaging of chemicals. This workshop is designed to be a practical guide to the implementation of GHS and CLP. Speakers will explain the key provisions of GHS, including labeling, training and SDS requirement. They will also summarise the current adoptions and future anticipated adoptions around the globe. The programme is designed to be highly practical and will include hands on group sessions. 0900 Coffee and Registration 0930-1700 SESSION 1 THE ROLE OF THE UN, FROM THE 1992 RIO EARTH SUMMIT AND AGENDA 21 TO GHS AND ITS GLOBAL IMPLEMENTATION, THE POLITICAL BACKGROUND TO GHS SESSION 3 THE CLP ELEMENT Speaker: Alex Paul, The REACH Centre, UK CLP, European Specific SESSION 4 GHS AROUND THE WORLD: PRACTICAL GUIDANCE FOR ACHIEVING GHS COMPLIANCE Understanding classification requirements for substances vs. mixtures Hierarchy of data and how to handle complex calculations A comparative analysis of country/authority variations An overview of classification cut-off limits Exemptions Best practices in labeling and SDS authoring Real world examples of how companies are working toward compliance Speakers: Catherine Bland, Technical Sales Support Manager EMEA, 3E Company & Paul Lloyd, Manager, Quality Systems & Products, 3E Company Speaker from UNITAR, United Nations Institute for Training and Research, Geneva SESSION 2 GHS 101: EXPLORING THE IMPACT OF A HARMONIZED SYSTEM The history and purpose of GHS Understanding the terminology Key provisions of GHS, including labeling, training and SDS requirement Sources of information/classification A summary of current adoptions around the globe A look ahead at anticipated adoptions Understanding the building blocks approach Speakers: Catherine Bland, Technical Sales Support Manager EMEA, 3E Company & Paul Lloyd, Manager, Quality Systems & Products, 3E Company, USA

Global Enforcement Summit: 20-22 October 2014, Brussels 3 WAYS TO TO REGISTER 1 www.chemicalwatch.com/enforcementsummit2015 2 3 sales@chemicalwatch.com +44(0) 1743 818 293 PRICES TWO-DAY SUMMIT 995 (Early Bird price if booked before 31/8/2015 NON SUBSCRIBERS: 1195 (after 31/08/2014) TWO-DAY SUMMIT 945 (Early Bird price if booked before 31/8/2015 CHEMICAL WATCH -SUBSCRIBERS: 1145 (after 31/08/2014) WORKSHOP 1: PREPARATION FOR INSPECTION UNDER REACH 545 Payment options: 1. Invoice payable by bank transfer, credit card or cheque made payable to CW Research Ltd. 2. Online using our secure order-form Payment must be made before the event starts WORKSHOP 2: GHS IMPLEMENTATION A PRACTICAL GUIDE 545 LOCATION & TIMINGS Le Chatelain Boutique Hotel Brussels Rue du Chatelain 17 B-1000 Brussels Belgium Reservations: Tel.: +32.2.646.00.55 res@le-chatelain.com We have arranged a special bedroom rate for Summit participants at Le Chatelain Boutique Hotel: 165 per night. Participants will be sent a link for booking hotel accommodation directly with the hotel. EVENT TIMINGS: Tuesday 20 October 09:30-17:00 Wednesday 21 October 09:00-17:30 Thursday 22 October 09:00-17:30