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REACH: 2018 and beyond


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Whether you are well-versed in chemical regulations or brand new to the field- you can't afford to miss Enhesa's upcoming webinar on November 14 & 16, 2017.
During the webinar, Enhesa's Head of Product Stewardship, Catarina Olagnier-Hastesko, will go over:

-A quick guide on REACH
-What is happening around EU REACH at the moment, including: new guidance on substances in Articles, new upcoming anti-poison Centre notification, 2018 registration deadline etc
-An update on the “spread of REACH” in the world, including some interesting comparisons and examples of differences
-An overview of upcoming issues

With 11+ years of experience in product stewardship, Catarina Olagnier-Hastesko is the Head of the Product Stewardship team at Enhesa. Ms. Olagnier-Hastesko is a Swedish lawyer with a LLM from both the College of Europe in Belgium and from the University of Lund in Sweden.

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REACH: 2018 and beyond

  1. 1. This document is confidential. All rights reserved. No part of this presentation may be reproduced, reused or transmitted in any form or by any means, electronic or mechanical, without written permission from Enhesa.
  2. 2. REACH: 2018 and Beyond… Presented By: Catarina Olagnier-Hästesko
  3. 3. ©2016 Enhesa. All rights reserved.REACH: 2018 and Beyond WE’VE GOT YOU COVERED 75+ Regulatory Experts 14,000+ Registered Users Three Global Locations All Industry Sectors 275+ Jurisdictions Compliance Intelligence Regulatory Forecaster Expert Support Services 4
  4. 4. ©2016 Enhesa. All rights reserved. 5 Enhesa Webinar Series An Overview Held on a regular basis Download webinars on Enhesa’s website. Our library of past webinars include: • Slide decks • Recordings Share your feedback on the post-webinar survey! Complimentary webinars on topics covering: • Environmental, health & safety • Product stewardship • EHS auditing Not on our mailing list? Send an email to: to have your name added to our distribution list. Do you have topic suggestions for our future webinars? • Note them on the post-webinar survey • Email us REACH: 2018 and Beyond 5
  5. 5. ©2016 Enhesa. All rights reserved. 6 PRACTICAL DETAILS Today’s Moderator Muting and Sound Quality Question and Answer o Due to the number of participants, we have muted everyone to ensure good sound quality o If you experience sound quality problems, please make sure you are using a wired connection with adequate bandwidth. If the problem continues, please call into the teleconference o Thank you for submitting your questions during registration. We will answer as many as possible during our Q&A session. o Tjeerd Hendel-Blackford, Head of Thought Leadership at Enhesa REACH: 2018 and Beyond 6
  6. 6. ©2016 Enhesa. All rights reserved. 7 TODAY’S PRESENTER REACH: 2018 and Beyond Catarina Olagnier Hästesko Head of the Product Stewardship team at Enhesa With 11+ years of experience in product stewardship, Catarina Olagnier-Hästesko is the Head of the Product Stewardship team at Enhesa. Ms. Olagnier-Hästesko is a Swedish lawyer with a LLM from both the College of Europe in Belgium and from the University of Lund in Sweden. 7
  7. 7. ©2016 Enhesa. All rights reserved. 8 Agenda… 1. Refresher on EU REACH 2. Guidance on articles 3. Upcoming issues in the EU 4. REACH Worldwide – zooming in on examples 5. Q&A REACH: 2018 and Beyond 8
  8. 8. ©2016 Enhesa. All rights reserved. REACH 9REACH: 2018 and Beyond Ensure high level of protection of human health and the environment Gather information Communicate information to the authorities Communicate information to the usersObligations Aim
  9. 9. ©2016 Enhesa. All rights reserved. Registration Evaluation AuthorizationRestriction of Chemicals REACH: 2018 and Beyond 10 R E Ch A
  10. 10. ©2016 Enhesa. All rights reserved. Registration Evaluation Authorization Restriction of Chemicals REACH: 2018 and Beyond 11
  11. 11. ©2016 Enhesa. All rights reserved. REGISTRATION No Data – No Market oManufacturers and importers in the EU and EEA (EU 28 + Norway, Iceland and Liechtenstein) oNon-EU manufacturers: Only representatives oWide scope – few exemptions (examples: waste, polymers, non-isolated intermediates) o1 metric tonne/year (or more) oTransitional period w differentiated deadlines based on quantity and hazard priority o≥ 1000 tonnes /y, CMR ≥1 t/y (2010), very toxic to aquatic organisms ≥100 t/y o≥ 100 tonnes/y (2013) o≥ 1 tonne / y (31 May 2018) REACH: 2018 and Beyond 12
  12. 12. ©2016 Enhesa. All rights reserved. 2018 REGISTRATION Last registration deadline for ‘existing’ (phase-in) substances (for 1-100 t/y) 31 May 2018 o130,000 pre-registered substances remaining oCompanies must work together (incl. competitors) and share data in the 'Substances Information Exchange Forum' (SIEF) oCertain substances have hundreds of registrants (consortia) oShare data, exchange information and agree on C&L oDatasharing costs: (not for profit) study, administrative costs, risk premium, inflation, late-come penalties not allowed, reimbursement scheme, use rights oUpdates when changed: quantities, use, new knowledge of risk, C&L, CSR… REACH: 2018 and Beyond 13
  13. 13. ©2016 Enhesa. All rights reserved. Registration Evaluation Authorization Restriction of Chemicals REACH: 2018 and Beyond 14
  14. 14. ©2016 Enhesa. All rights reserved. EVALUATION European Chemicals Agency (ECHA) evaluates the registration dossiers o Min. 5% of dossiers (2010 batch- 35%) o List of substances potentially subject to compliance check Member States evaluate the substances o Prioritised upon hazard and total quantity on the market oCommunity rolling action plan (CoRAP) for 2018-2020 includes 107 substances o Already have 12,000 unique substances to evaluate o Harmonised C&L o OEL o Substance of Very High Concern (SVHC) “Candidate List” o Restriction REACH: 2018 and Beyond 15
  15. 15. ©2016 Enhesa. All rights reserved. Registration Evaluation Authorization Restriction of Chemicals REACH: 2018 and Beyond 16
  16. 16. ©2016 Enhesa. All rights reserved. RESTRICTIONS oAnnex XVII oList of marketing and use rules for substances both in mixtures and articles Examples: o“Cadmium…shall not be used or placed on the market…if concentration is ≥ 0,01 % w/w in…metal parts of jewellery” oSubstances that are classified as carcinogenic, mutagenic or toxic to reproduction (CMR), category 1A or 1B, shall not be placed on the market, or used…for supply to the general public oForward warning: List of restriction intentions published by ECHA REACH: 2018 and Beyond 17
  17. 17. ©2016 Enhesa. All rights reserved. Registration Evaluation Authorization Restriction of Chemicals REACH: 2018 and Beyond 18
  18. 18. ©2016 Enhesa. All rights reserved. AUTHORIZATION oAuthorization List - a list of ”banned” substances (Annex XIV) oCommission adopts authorization decisions oAuthorizations are granted for specific uses, persons, time limits, and e.g. conditions of risk management oMay be reviewed if new data comes up oFew authorizations granted (list available on EU Commisison website) REACH: 2018 and Beyond 19
  19. 19. ©2016 Enhesa. All rights reserved. LISTS BEFORE THE LIST 20REACH: 2018 and Beyond Registry of Intentions Proposal from ECHA/MS Candidate List/ SVHC 2/year 174 substances Recommendations 1/year 24 substances 7 consultations (2017) Authorization list 43 substances Commission Decision
  20. 20. ©2016 Enhesa. All rights reserved. DEFINING ARTICLES Candle Wax Crayon Paper Substances Mixtures Articles Articles with Intended Release REACH: 2018 and Beyond 21
  21. 21. ©2016 Enhesa. All rights reserved. OBLIGATIONS FOR ARTICLES INCL SVHC Obligation to submit a notification to ECHA If SVHC in the article in a concentration above 0.1% w/w and >1 tonne/y, Unless:  no exposure to humans or the environment, or  the substance has already been registered for that use Obligation to communicate information to users If SVHC in the article in a concentration above 0.1% w/w What: Sufficient information to allow safe use (minimum name of the substance) When: B2B – always; B2C - within 45 days of request - free of charge REACH: 2018 and Beyond 22
  22. 22. ©2016 Enhesa. All rights reserved. THE 0.1 % CONCENTRATION “Once an article – always an article” REACH: 2018 and Beyond 23 SVHC > 0.1% w/w SVHC < 0.1% w/w
  23. 23. ©2016 Enhesa. All rights reserved. NEW GUIDANCE ON SUBSTANCES IN ARTICLES “Complex object” and “very complex object” How to calculate the concentration limit in different types of complex objects: • Main rule: article by article (w/w) • A different scenario: • Complex article coated with a mixture containing a SVHC • Two articles glued together with adhesive containing SVHC  SVHC calculated in relation to the total weight of the complex object when the glue or paint contains a SVHC- the glue or paint has “become an integral part of the object” REACH: 2018 and Beyond 24
  24. 24. ©2016 Enhesa. All rights reserved. NEW GUIDANCE ON SUBSTANCES IN ARTICLES (CONT.) Notification needs to contain a description of the articles that contain the SVHC and the technical use of the substance in those articles “In most cases: Easier to submit a notification than to demonstrate that the exemptions apply”. (ECHA Webinar 2 Nov 2017) Obligation to inform users: Which articles that contain the SVHC in concentrations above 0.1% Sufficient information to allow safe use during the entire life cycle of the article: Examples given by ECHA: “Due to the presence of this substance…wash hands after handling, do not open, keep away from children, dispose of as WEEE, …” REACH: 2018 and Beyond 25
  25. 25. ©2016 Enhesa. All rights reserved. NEW GUIDANCE ON SUBSTANCES IN ARTICLES (CONT.) Compliance Management – in practice oGuidance states the “determination of the concentration of a Candidate List substance in an article must always be done on a case-by-case basis.” oCompanies need to go through entire object, article by article to determine if SVHC is present (knowledge about use of SVHC and materials that could potentially contain SVHC, as well as knowledge about the materials in the very complex objects) Enforcement: EU-wide enforcement project from October 2017 – June 2018 oTo date very few notifications o Main focus: consumer products, electrical products, building and interior articles oAnalysis will be performed on individual articles (past experience many companies claim that their products don’t contain SVHC but they do) oEasier for enforcement authority when they can test any component REACH: 2018 and Beyond 26
  26. 26. ©2016 Enhesa. All rights reserved. AN OVERVIEW OF UPCOMING ISSUES oGrouped chemicals approach oTax on chemicals oEarly warning systems & tracking chemicals in their lifecycles oLifecycle – sourcing requirements oGreen / sustainable chemistry (avoiding hazardous substance generation) oFocus on prevention (hazard elimination and risk reduction) oSharing data and BAT/BEP oAccess to increase of information- informed decisions by companies and consumers oSINlist – SINimilarity oNGOs will continue pushing for voluntary action by companies o Disclosure of ingredients o Substitution of hazardous substances 27REACH: 2018 and Beyond
  27. 27. ©2016 Enhesa. All rights reserved. ENDOCRINE DISRUPTORS • EDs are a category of SVHCs that can be subject to Autorisation regime. • No clear defining criteria in EU legislation (incl. REACH) • After years of discussion MSs and Commission had agreed on criteria in July 2017. Needed agreement by Parliament to become final. • October 2017: Parliament voted against the proposed ED criteria (not sufficient to protect human health and the environment) • Commission has to come up with a new definition of EDs. • Consequence: Not expected to see legally binding criteria for EDs soon REACH: 2018 and Beyond 28
  28. 28. ©2016 Enhesa. All rights reserved. NANOMATERIALS 2017: ECHA published two new guidance documents to help companies register nanoforms under REACH Pending draft amendment to REACH (public consultation ended on 6 Nov. 2017) proposed: • New risk assessment and risk management measures for nanoforms to address their specific toxicological profiles and exposure patterns. • Manufacturers and importers of nanoforms would have to provide specific information in their REACH registration dossier, like particle size, shape and surface properties of nanoforms. • Downstream users modifying the nanoforms of a substance they use would have to notify their supply chain or cover their use in their chemical safety report (CSR). • Foreseen entry into force: 1 January 2020 REACH: 2018 and Beyond 29
  29. 29. ©2016 Enhesa. All rights reserved. ANTI-POISON CENTRE NOTIFICATION oAim: information available for emergency responses in cases of intoxication oImporters and downstream users placing hazardous mixtures on the market oAll the components Implementation: 1 January 2020 to 1 January 2025 oBefore placing the mixture on the market oUnique Formula Identifiers – labelling requirement oProduct Categorization System oCentral Notification Portal oPlanning required: Budget & Resources REACH: 2018 and Beyond 30
  30. 30. ©2016 Enhesa. All rights reserved. BREXIT – UK REACH? No decision taken yet • 30 March 2019 – UK becomes a non-EU country • ECHA: o UK registrations will be regarded as “non-existent” and authorisations will cease to have an effect o Only representatives in the UK can no longer be used o Downstream users in the EU will become importers and need to register o UK Lead registrants to transfer role to other registrant or transfer role to own legal entity in EU 27 • Industry wants to keep ’Status Quo’ (according to UK’s Chemical Business Association (CBA) Brexit position paper – Sep 2017): o UK chem industry considers crucial that UK remains a member of the Single Market and Customs Union o “the pragmatic and most cost-effective way forward is to adopt the REACH, CLP, and Biocides legislation into UK law on exactly the same institutional, functional, and legislative terms as they are currently operating” o Should Brexit negotiations fail to deliver this outcome several CBA member companies suggest exploring derogations to trade in substances regulated on a risk-based approach (rather than hazard- based). 31REACH: 2018 and Beyond
  31. 31. ©2016 Enhesa. All rights reserved. THE WORLD OF REACH-LIKE LEGISLATION Proposed EU +EEA Implemented
  32. 32. ©2016 Enhesa. All rights reserved. TURKISH REACH: KKDIK Published on: 23 June 2017 Intentionally aligned with EU REACH, to facilitate trade with the EU REACH: 2018 and Beyond 33 Similarities oDefinitions and scope oControl systems (registration, restriction and authorization) oData requirements Differences oSame deadline regardless of tonnage (≥ 1 t/y) opreregistration by end of 2020 oregistration by end of 2023 oNeed Certified Chemical Safety Assessors (qualified according to Turkish rules) oTurkish language
  33. 33. ©2016 Enhesa. All rights reserved. K-REACH Act on the Registration and Evaluation of Chemicals (“K-REACH”) In force: 1 June 2015 Registration Designated existing substance (≥ 1 t/y) New substance (all) Annual reporting Hazard assessment Risk assessment Designated as toxic substance Designated as restricted/banned substance Designated as autorization substance Substances Products Product containing > 0.1% hazardous chemicals ≥ 1 t/y Notification Publication of standards for safety & labeling 34
  34. 34. ©2016 Enhesa. All rights reserved. K-REACH (cont.) Proposed Amendments • Registration required for ALL existing substances ≥ 1 t/y (not limited to ‘priority evaluation chemicals’) • Repeal of annual reporting requirements (both for existing and new substances) • New separate K-BPR proposed would consolidate rules regarding ‘products of concern’ in K-REACH • For <100kg/y new substances, a notification system would be introduced to replace current small quantity registration Current differences with EU • Registration of existing chemical substances (≥1t/y) only required for priority evaluation chemicals (list of designated existing substances by the regulator) • Annual reporting volume and uses (for all new substances and ≥ 1t/y existing substances) • Covers biocides (‘products of concern’) • (Simplified ) registration required for new substances in volumes <1t/y 35
  35. 35. ©2016 Enhesa. All rights reserved. K-REACH (cont.) Proposed Amendments • A pre-registration system for existing substances • Proposed registration deadlines for existing substances ≥ 1 t/y: • 2021: >= 1000 t/y and carcinogenic, mutagenic or toxic for reproduction (CMR) • 2024: 100 - 1000 t/y • 2027: 10 - 100 t/y • 2030: 1 -10 ton/y • Data requirements depend on tonnage bands and GHS classifications. For substances which are not classified as hazardous according to GHS, required data can be significantly reduced • Further requirements to inform downstream users of hazardous chemicals Current differences with EU • Korean language • No SIEF concept (can share data anyway) • Application of confirmation of registration exemption required for substances for R&D purpose, non-isolated intermediates and surface treated substances • Notification and risk assessment of consumer products containing hazardous substances • Registration of polymers required 36
  36. 36. ©2016 Enhesa. All rights reserved. RUSSIAN REACH-LIKE o Technical Regulation for chemical product safety (Government Decree no. 1019) – will enter into force 1 July 2021 o Distinguishes o Existing chemicals, meaning substances and mixtures already listed in the “Register of Substances and Mixtures” (Data base managed by authorities incl. approx. 10.000 substances); and o New chemicals (chemical not listed in the Register or mixture containing at least 0.1% w/w substance not listed in the register) o Companies intending to introduce new chemicals on the Russian market must notify the register, including: substance identification, intended uses, measures for risk prevention, analytical report, physio- chemical properties, data on toxicology and eco-toxicology, chemical safety report… o In addition to the notification of new chemicals, chemical products will also have to obtain a registration certificate (type of conformity assessment) before being placed on the market. Two alternative procedures, depending on the level of risk involved with the product: o “Account State Registration” for lower risk chemical products o “Permitting State Registration for higher risk chemical products (including those containing new substances) o More implementing legislation is expected to set out procedures details and make the system operational o May still register under the ‘current regime’ (before 1 July 2021) and be regarded as an existing substance 37
  37. 37. ©2016 Enhesa. All rights reserved. 38 Increase efficiency, save money and time Facilitate communication of EHS risks, performance, and value to all stakeholders Be proactive and prepare for EHS regulatory change Focus on your core business Access to local expertiseEnsure quality and standard information globally ? WHY REACH: 2018 and Beyond 38
  38. 38. ©2016 Enhesa. All rights reserved. 39
  39. 39. Thank You! ©2016 Enhesa. All rights reserved. 40