REACH: What ITI members need to know to limit business risk Insert then choose Picture select your picture. Right click your picture and Send to back. Sarah Medearis ERM Partner, Product Stewardship Services Lead Copyright 2017 by ERM Worldwide Limited and/or its affiliates ( ERM ). All Rights Reserved. No part of this work may be reproduced or transmitted in any form or by any means, without prior written permission of ERM. The business of sustainability
What this session is all about. Overview REACH Substances in Articles (Sept 2015 ECJ Ruling) 2018 REACH Registration Deadline and Obligations REACH SVHC s and Notification/Communication Requirements REACH Compliance Challenges and Strategies Reduce Hazardous Chemicals Communicating Chemical Hazards Manufacturer, Importer, User Responsibility 2 2
Overview of REACH Substances in Articles Reduce Hazardous Chemicals Manufacturer, Importer, User Responsibility Communicating Chemical Hazards The Building business a sustainable of sustainability organization through learning CONTENTS COPYRIGHT 2011 ERM
REACH applies to substances put on market within the EEA* All** Uses In Mixtures, Alloys, Articles Complete Life Cycle * Includes Iceland, Norway, Liechtenstein ** Unless specific equivalent legislation exists Substances*** *** Includes metals and monomers used to make alloys, polymers (plastics) 4 4
REACH products and substances in scope 5 5
REACH substances mixtures articles 6 6
September 10, 2015 ECJ ruling and once an article, always an article under REACH September 10, 2015, EU Court of Justice (ECJ) clarified what constitutes an article under REACH Placed unprecedented burden on producers of complex articles REACH compliance must now be evaluated down to the individual component level down the supply chain Evaluate and communicate/notify of SVHC s on an individual component level 7 7
REACH requirements for substances in articles Registration: Only for substances >1 tpy that are intended to be released from articles (Articles 7(1)) Registration Notification: Only for candidate list substances >0.1% w/w and >1 tpy in articles (Article 7(2)) Communication: Only for the candidate list substances >0.1% w/w in articles (Article 33) ECHA Notification Substances in Articles DU Communication Restrictions: may apply (Annex XVII) to substances in articles. Source: ECHA Guide on requirements for substances in articles, Dec 2015) DU = Downstream User ECHA = European Chemicals Agency Restriction 8 8
REACH substances of concern in articles 3-step process for SVHCs* 1. Member State/ECHA propose a substance that meets SVHC criteria 1,000+ substances that meet SVHC Criteria Class 1A, 2A CMR** PBT/ vpvb*** Equivalent concerns (e.g., endocrine disruptors) 9 2. Candidate List of Substances Publish Candidate List Triggers obligations for suppliers of SVHCs alone, in mixtures or articles 3. ECHA prioritizes and recommends substances for Annex XIV Authorisation List with sunset dates Sunset data from which placing on market and SVHC use is prohibited unless authorization granted or the use is exempt Continuous process * SVHC = substances of very high concern **CMR = Carcinogenic, Mutagenic, Reprotoxicant *** PBT = Persistent, Bioaccumulative and Toxic, vpvb = very Persistent, very Bioaccumulative Candidate List Annex XIV 9 173 Substances Obligations for suppliers of the SVHCs alone, in mixtures and in articles Authorisation List 34 Substance entries Companies applying for Authorisation
REACH substances with restricted uses in a nutshell Specified supply/use/presence not allowed Can apply to substances alone, in mixtures and/or in articles REACH Annex XVII with ~450 substances Took effect on 1 June 2009 Applies to specific uses No general tonnage threshold Not always an outright ban All uses allowed except Restricted uses 10 http://echa.europa.eu/addressing-chemicals-of-concern/restrictions/list-of-restrictions/list-of-restrictions-table 10
REACH registration vs authorisation in a nutshell 11 Registration Process to gather information about substances Considers life cycle and supply chain uses Duty of substance manufacturer/ importer Triggered at 1 tonne per year per legal entity Involves Cooperation with others: sharing and generating information New ways of working: SIEFs, joint submission New software tools: REACH-IT and IUCLID5 Expert resources Changes to business plans Lots of money Authorisation No EEA supply or use after sunset date Applies to substances alone and in mixtures REACH Annex XIV: Authorisation List Applies to all uses, unless exemption applies Must seek and gain permission from European Commission for the use of the substance No general tonnage threshold 11
Key Elements and Impacts of REACH Key Elements of REACH Each manufacturer/importer to pre-register and register substances and have accurate information Downstream users informed in order to manage risks The law forces a move to safer substances And Inevitably Some substances will: not be on the market be more expensive be in limited supply be phased out Some uses will not be part of registration 12 12
2018 REACH Registration Deadline and Obligations Reduce Hazardous Chemicals Communicating Chemical Hazards Manufacturer, Importer Responsibility The Building business a sustainable of sustainability organization through learning CONTENTS COPYRIGHT 2011 ERM
Registration timeline 1 June 2007 1 June 2008 1 Dec 2008 6 months Phase-in registration deadlines 30 Nov 2010 31 May 2013 31 May 2018 REACH EIF* Pre-registration Registration of CMR cat 1 & 2 1tpy R50/53 (v toxic to aquatic life) 100tpy phase-in substances 1000 tpy Registration of phase-in** substances 100 tpy Registration of phase-in** substances 1 tpy 14 Registration of non-phase-in substances & phase-in** substances that have not been pre-registered * European Interoperabilty Framework for pan European REACH services ** Phase-in substances are chemicals to be phased into REACH and are either current EINECS substances, substances manufactured in the EU but not placed on market before 6/1/07 or no longer polymer substances. Non-phase in substances are substances notified under previous scheme from 1981 and considered already registered under REACH (ELINCS), any new chemical invented after 6/1/07, registered under REACH and >1 tpy 14
Summary of REACH obligations down the value chain Processor/Formulator Article Manufacturer Downstream User Manufacturer Article Importer An EU legal Importer entity using a substance An EU legal entity manufacturing Any legal or entity using substances or mixtures in An EU legal Any EU entity legal to produce entity responsible a mixture/polymer. for the import Use An EU legal entity who imports assembling a finished good. the course Only of industrial or professional activities. manufacturing of substances a within scope or mixtures. of suppliers Registration, registration. finished goods or components. use substances within Only scope use of substances within the scope of suppliers substance. Communications Communications & Authorisation. obligations Supply registration, and Communication of presence of Communication of Registration, registration. Poss. Authorisation supply chain possible chain Authorisation disruption & restriction SVHC s & restriction SVHC s, Authorisation supply chain Communication, disruption. req t. disruption, restriction. Authorisation. Agent/Distributor An EU legal entity who distributes chemicals and articles with no chemical handling. Communication obligations. Consumer An EU legal citizen. Has the right to Retailer ask retailers about the presence of SVHC s An EU legal entity who supplies to the general public. Communication of SVHC presence in mixtures and articles within 45 days of consumer request. 15
Summary of REACH obligations down the value chain 16
REACH SVHC s and Notification/ Communication Requirements Reduce Hazardous Chemicals Manufacturer, Importer Responsibility Communicating Chemical Hazards The Building business a sustainable of sustainability organization through learning CONTENTS COPYRIGHT 2011 ERM
REACH notification and communication requirements: articles with Candidate List substances 18 Duties outlined in REACH Article 7(2) (ECHA Notification) and Article 33 (User Communication) Notification and Communication requirements for articles containing Candidate List SVHC > 0.1% w/w Notify ECHA if >1 tpy per SVHC per legal entity and not already registered for your use Proactive B2B communication for industrial, commercial users that Candidate List SVHC present and about safe use (no tonnage trigger) Reactive B2C communication to individual consumers the same information within 45 days of request (no tonnage trigger) 18
Proactive communication of industrial and commercial users (B2B) under REACH Provide the recipient... sufficient information, available to the supplier... safe use... Articles with Cand. List SVHC s >0.1% w/w (on a part/component level) Need a plan and coordinator; brief customers How to communicate: Technical datasheets? Information on invoices? SDS/Labels? Advertisements? Website posting not sufficient 19 Applies to articles produced/ imported before the substance included in the Candidate List 19
Reactive communication to consumers under REACH (B2C) EEA consumers have right to same information, by written request Supplier must provide requested information within 45 days Need a plan, a coordinator & a focal point for contact Need to understand the law and the requests 20 20
REACH Compliance Challenges and Strategies Reduce Hazardous Chemicals Manufacturer, Importer Responsibility Communicating Chemical Hazards The Building business a sustainable of sustainability organization through learning CONTENTS COPYRIGHT 2011 ERM
REACH compliance challenges and strategies 22 Compliance Challenges Keeping abreast of substances included in Candidate List (Annex XIV) or subject to Restriction (Annex XVII) Identify SVHCs >0.1% in supplier parts/components for communication Identify SVHCs >0.1% in supplier parts/components that you then put into EEA >1 tpy for ECHA notification Compliance Strategies Chemicals Management Program that: Tracks regulatory updates (e.g., subscription services) Manages supplier REACH compliance declarations (e.g., resources, processes, tools) Tracks substance volume thresholds for products put on market Track industry-wide supplier database and standards (e.g., IPC Standard 1754, CDX, IMDS, IAEG WG2) Communicates and Notifies SVHCs >0.1%, >1 tpy 22
REACH compliance strategies and best practices for articles Outsourced Services & Software Industry associations Annex XIV and XVII Chemical Regulatory Updates Supplier Parts REACH Compliance Mgmt Software and industry-wide databases Internal supply chain resources Supply chain audits Software flagging SVHC>0.1% based on supplier data Software flagging SVHCs >1 tpy based on sales SVHC Concentration and Volume Tracking SVHC Communication/ Notification Standard SVHC communication materials Tracking customer uses ECHA Notification 23 23
REACH compliance programs are cross-functional Engineering Material, part specifications EHS Regulatory Tracking, REACH compliance Program Purchasing Supplier engagement, supplier approval, document management Sales Product/substance volume tracking, customer use and inquiry management 24 24
REACH compliance strategies and best practices for articles Address non-compliance Address tool, processes or resources deficiencies Notify leadership of progress, risks and mitigation measures Act Plan REACH Compliance Strategy Communicate resources, processes and tools and supplier requirements Develop program KPI s Check Do Audit suppliers Audit REACH compliance program across BU s functions Execute plan and engage internal and external resources, tools, and harmonized processes 25 25
REACH Is a risk to business continuity Presents significant strategic business issues And opportunities Compliance involves all business functions Regulatory, legal, safety, quality, purchasing, sales Meeting obligations Staying competitive 26 26
REACH Compliance References ECHA Guidance on Requirements for substances in articles. December 2015. https://echa.europa.eu/documents/10162/23036412/articles_en.pdf/cc2 e3f93-8391-4944-88e4-efed5fb5112c ECHA REACH guidance. https://echa.europa.eu/guidancedocuments/guidance-on-reach ECHA Substances restricted under REACH. https://echa.europa.eu/addressing-chemicals-of-concern/restrictions ECHA Authorisation List. https://echa.europa.eu/addressing-chemicalsof-concern/authorisation/recommendation-for-inclusion-in-theauthorisation-list/authorisation-list REACH Enforcement in the UK. http://www.hse.gov.uk/reach/ourwork.htm 27 27
Questions/Discussion Thank you Sarah Medearis, ERM, sarah.medearis@erm.com Reduce Hazardous Chemicals Communicating Chemical Hazards The Building business a sustainable of sustainability organization through learning Manufacturer, Importer, User Responsibility CONTENTS COPYRIGHT 2011 ERM