23.02.2017, 04:00PM (EET) | Webinar REACH 2017 Agenda: Key deadlines and actions for industry
Disclaimer 2
REACHLaw in brief What we do? We provide global regulatory compliance and environmental sustainability services to ensure market access and operational sustainability for global businesses SERVICE AREAS KEY FACTS ABOUT US OUR CLIENTS Established in Helsinki Global chemicals regulatory More than 300 customers compliance, e.g. Offices in Brussels, New from 40+ countries, from Delhi and Istanbul Fortune 100 companies to REACH CLP 30+ toxicologists, chemists, SMEs. lawyers, socio-econ. Major industries served: Turkish Biocides Compliance analysts, business and Oil, chemicals, specialty environmental specialists chemicals, metals, K-REACH China REACH 20+ local partners in aerospace and defence We prepare the required Europe, Asia, Latin-America sector and the USA dossiers to authorities, Our customers are 350+ REACH registrations by SDSs, labels and provide manufacturers, importers, related business strategy, 2010 deadline, 5% /all OR traders, downstream users, legal and monitoring Language support in industry associations and support. 10+ different languages governmental eSpheres investor Provide Outsourcing organizations. More info about Us at: solutions for chemical compliance management www.reachlaw.fi Supply chain compliance management tools: www.compliantsuppliers.com 3
REACH 2017 Webinar REACH timeline Focus of today REACH 1+ Pre- 1000+/”SVHC” 100+ Entry into registration registration registration registration force Deadline Deadline Deadline Deadline Registration of Substances Evaluation by ECHA and Member States Candidate listing and Authorisation applications for SVHC SVHC Roadmap Restrictions for Chemical substances presenting an unacceptable risk 1.6. 30.11. 1.12. 31.5. 31.5. 2015 2007 2013 2016 2018 2008 2009 2010 2011 2012 2014 2017 2019 2020 NOW 4
AGENDA FOR PRESENTATION 1. Introductions 2. Late Pre-registration closes on 31 May 2017 3. Lead Registrant for 2018 and testing 4. Authorisation deadlines 5. Enforcement 2 nd REACH review (REFIT evaluation) 6. 7. Brexit vote consequences Q&A after the presentation: 8. Conclusions Please send questions using the chat! 5
Introductions Registration 2018 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 25 000 “new” 3 000 “new” 3 400 substances substances substances 20 000 registrations 9 000 registrations 70 000 registrations As of 11 January 2017 ( newest available data ): • – Registrations: 48 318 (this incl. smaller volumes of already registered substances) – Unique substances: 10 557 6
Introductions Registration 2018: Know Your Substance Portfolio 1. Determine your chemical portfolio in terms of substances – Substances on their own – Mixtures: which substances are in these mixtures – (Articles: which substances are intended to be released from them, not very common case) 2. Identify your substances and determine REACH Scope – Manufacture/Import ≥ 1 t/a (1-10, 10-100) – No exemption from registration – Intermediate only or Full dossier? – Hazard classification? Picture courtesy of ECHA 7
Introductions I Registration is only the start… CoRAP Registration D list Evaluation D Candidate list Annual Screening Risk Year Substance s Annex 2017 162 managment D XIV list 2014- 893 2016 PACT AfA list ROI Courtesy list of ECHA 8
AGENDA FOR PRESENTATION 1. Introductions 2. Late Pre-registration closes on 31 May 2017 3. Lead Registrant for 2018 and testing 4. Authorisation deadlines 5. Enforcement 2 nd REACH review (REFIT evaluation) 6. 7. Brexit vote consequences Q&A after the presentation: 8. Conclusions Please send questions using the chat! 9
Late Pre-registration closes on 31 May 2017 Can you still late pre-register? YES if cumulatively (REACH Art. 28(6): Therefore excluded: + You manufacture or import — Non-phase in substances (not fulfilling the definition in Art. 3(20)) + An existing ”phase - in” substance (REACH Art. 3(20)) — Substances subject to previous 2010 and 2013 deadlines, i.e. + in quantities of ≥1 t/y - <100 t/y, manufactured/imported ≥100 t/y or with 31.5.2018 registration deadline CMR Cat. 1/2 ≥1 t/y (according to Directive 67/548/EEC) + for the first time, after 1.12.2008 — ”First - time” Only Representative for + You pre-register within 6 months of substances already exported to EEA first manufacturing/importing and no ≥1 t/y after 1 June 2008 (including to later than on 31 May 2017 Importers with a pre-/registration) You are allowed to continue manufacturing or You need to pass an ECHA inquiry and register import without registration until 31 May 2018 before you may start manufacture/import 10
Late Pre-registration closes on 31 May 2017 Possibilities for ”late” non -EU manufacturers Strategy to avoid business disruptions for non-EU manufacturer wishing to appoint an Only Representative for the first time now while the late pre-registration conditions are not fulfilled: Only Representative (OR) inquiry and registration • • Until completed OR registration: Channel exports through validly pre-/registered EU customers (importers) – established importers may have already pre-/registered – ”first - time” importers may still be eligible for late pre - registration OR registration relieves importers covered by it • from (further) registration / update responsibilities. 11
Late Pre-registration closes on 31 May 2017 Possibilities for ”late” non -EU manufacturers Makes good business sense to appoint an OR Why? 1. more control over the whole REACH process 2. centralised administration function 3. control of confidential and proprietary data/information 4. only one registration cost per substance 5. your importers become ‘downstream users’ of the OR 6. updating of registration info is easier 7. competitive advantage www.reachlaw.fi 12
EU Only Representatives REACHLaw is one of the foremost Only Representatives in the EU, representing several hundred non-EU/EEA companies worldwide ( North America, South America, non-EU/EEA Europe, Asia, Africa, Oceania, Middle East, … ) 13
AGENDA FOR PRESENTATION 1. Introductions 2. Late Pre-registration closes on 31 May 2017 3. Lead Registrant for 2018 and testing 4. Authorisation deadlines 5. Enforcement 2 nd REACH review (REFIT evaluation) 6. 7. Brexit vote consequences Q&A after the presentation: 8. Conclusions Please send questions using the chat! 14
Lead Registrant for 2018 Way Forward for 2018 Registrations for once you know your REACH substance portfolio EU/EEA Manufacturer / Importer Only Representative = Role If not already pre-registered: “late” pre-register the substance = Activities (where permitted) = Decisions If a non competent company has taken Check whether (2010 / the LR position 2013) joint registration then available YES NO is available? options are only difficult ones due to the OSOR Prepare Co-Registration dossier(s), principle Leadership for 2018 registration is already purchase LoA(s) and registers taken up by a company that can be trusted to produce the registration in time ahead of the YES NO 31.5.2018 deadline? Decide whether to participate in leader- Consider whether to take the lead registrant ship cooperation / consortium or monitor role a.s.a.p. well before 2018 the progress and purchase LoA later (No time to waste) Prepare Co-Registration dossier(s), Prepare Lead Registration dossier and sell purchase LoA(s) and register LoA(s) to Co-Registrants and submit registration 15
Lead registrant for 2018 Steps to be completed: A Big Responsiblity Getting started Prepare joint submission Submission and follow-up • Lead dossier to ECHA SIEF communication Identification of critical • • • Grant joint submission substances for 2018 • Data collection incl. uses access to co-registrants • Data gap analysis without lead registrant Update (extended) • • 2018 test program, incl. • Estimate registration Safety Data Sheet non-testing methods costs • Data gap filling: Testing • Keep dossier up-to-date Selection of consultant • Prepare IUCLID dossier (spontaneous updates) • Obtain lead registrant • ≥10 t/y: Chemical Safety Respond to authority • • mandate from (pre-)SIEF requests, e.g. ECHA Assessment and CSR, and inform ECHA compliance check incl. Hazard assessment ( Leadership agreement • C&L) and Exposure Continuous financial • ( less common for 2018 ) Assessment (if hazardous) management, e.g. • Define and agree Financial management, • reimbursement in case of substance ID esp. cost calculations new co-registrants SIEF Agreement / LoA • NOW URGENT Submit before April 2018 16
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