REACH 2018 Stay on the market - register your chemicals

Purpose of this presentation This presentation, with notes, was prepared by ECHA, the European Chemicals Agency, to assist you in preparing a presentation about the REACH 2018, i.e. last registration deadline of phase-in substances. The intention is that you can select relevant slides and modify them as necessary to suit your audience, whether it is management, workers, environmental health and safety professionals, authorities etc. You may use it without additional permission. This presentation gives a brief overview of the registration in the context of REACH and gives an overview of ECHA’s REACH 2018 Roadmap. It is the opening of a series of presentations relating to REACH 2018, which are on the ECHA website. We welcome your comments and suggestions at reach-2018@echa.europa.eu. Legal notice: The information contained in this presentation does not constitute legal advice and does not necessarily represent in legal terms the official position of the European Chemicals Agency. The European Chemicals Agency does not accept any liability with regard to the contents of this document. Release: May 2016, updated May 2017

Outline Background REACH registration by 2018 ECHA‘s REACH 2018 Roadmap Six phases to successful registration REACH 2018 Communication This slide set provides a package to explain ECHA’s approach to help inexperienced and SME registrants to fulfill their registration obligations of phase-in substances by 31 May 2018. The slide set is based on ECHA’s REACH 2018 Roadmap. It is available on ECHA’s website: http://echa.europa.eu/documents/10162/13552/reach_roadmap_2018_web_final_en.pdf.

Background In this section a short overview on the overall objectives of REACH registration is given.

REACH registration Knowledge on hazards and uses of substances is a pre-requisite for responsible action REACH puts the burden of proof to individual companies – they have to demonstrate that their substances can be used safely Companies collect information, analyse it and document their conclusions in a registration dossier Information from registrations is used by authorities and published by ECHA on its website Registration of chemicals already in the European market in a stepwise manner: 2010, 2013 and 2018 REACH reversed the burden of proof on safe use of chemicals: It is now up to companies to demonstrate that the chemicals they manufacture or import in the EU do not cause unacceptable risk to human health or the environment. Companies record their findings and conclusions in a registration dossier which is submitted to ECHA. Information in the registration dossiers is used for further regulatory processes At least 5% of the registration dossiers are evaluated, i.e. it is analysed whether the information provided is compliant with the REACH requirements. The registration database is screened for substances that might warrant further/EU-wide risk management measures such as harmonised classification, authorisation or restriction Registration dossiers are also the basis for substance evaluation, i.e. Member State analysis of substances of potential concern Finally, information given by companies in the registration dossiers is disseminated on the ECHA website for free as stipulated in REACH. Anybody interested can search information on substances that interest them. This helps European citizens to make informed decisions on chemicals they use and may be exposed to. REACH put in place a staggered system to register so called ”existing” chemicals, called phase-in substances under REACH. If potential registrants pre-registered them in 2008*, they could benefit from staggered registration deadlines 1 December 2010: substances manufactured/imported by a registrant at or more than 1000 tonnes/year, environmentally most dangerous substances manufactured/imported by a registrant at or more than 100 tonnes/year and CMR substances manufactured/imported by a registrant at or more than 1 tonne/year. 31 May 2013: substances manufactured/imported by a registrant at or more than 100 tonnes/year 31 May 2018: substances manufactured/imported by a registrant at or more than 1 tonnes/year *Companies that are only now entering the market for a phase-in substance manufacturing or importing it 1-100 tonnes/year can still late pre-register them by 31 May 2017. FURTHER READING: ECHA’s compliance check strategy: http://echa.europa.eu/documents/10162/13608/echa_cch_strategy_en.pdf Guidance in a Nutshell on Registration: http://echa.europa.eu/documents/10162/13632/nutshell_guidance_registration_en.pdf. NOTE: EU and Europe in the context of this presentation mean the EU Member States + the EEA countries Iceland, Liechtenstein and Norway where REACH Regulation applies.

Information flow from registration This is a schematic representation of the information flows related to registration. REACH is a risk based approach to chemicals management. Therefore for proper risk assessment information on both substance’s properties and uses are needed Information on uses comes from the downstream users. If they are organised, it is expected that their sector organisations collect information on uses and conditions of use and make it available to the registrants in a harmonised format (use maps). Even if downstream uses are not organised, they are encouraged to use the harmonised format to deliver their use information to registrants. Registrants as manufacturers and importers have the information on substances properties. Registrants document information on uses and properties in their registration dossier. If they register at or above ten tonnes/year, they will also conduct a chemical safety assessment covering the whole life cycle of their substance, and document the results in a chemical safety report. Authorities use the information in the registration dossiers for assessing the need for regulatory risk management measures such as harmonised classification and labelling, restriction and authorisation. Registration dossiers are also the basis for choosing substances for further scrutiny under substance evaluation process. Finally, majority of information in the registration dossiers is published for free on ECHA’s website. Registrants themselves use the information in the registration dossier and chemical safety report as a basis for compiling their safety data sheets. Under REACH, safety data sheets may have one or more exposure scenarios attached. Exposure scenarios outline use/use-group specific conditions for safe use of the substance. FURTHER READING: Guidance in a Nutshell on Chemical safety assessment: http://echa.europa.eu/documents/10162/13632/nutshell_guidance_csa_en.pdf Guidance in a Nutshell on the Compilation of safety data sheets: http://echa.europa.eu/documents/10162/13643/sds_nutshell_guidance_en.pdf. Guidance in a Nutshell for Downstream users: http://echa.europa.eu/documents/10162/13634/du_nutshell_guidance_en.pdf. Information on registered substances: http://echa.europa.eu/information-on-chemicals/registered-substances.

Public information on chemicals comes from registrations Infocard Brief Profile This slides illustrates how information submitted by companies to ECHA is published on ECHA’s website. The most concise way ECHA displays information on its website is called an ”Infocard”. It gives a summary of the key properties of the substance: how it is classified and whether it is hazardous or not. If the substance has worrying properties, the Infocard also shows how the substance is being scrutinised by the regulators. Brief profiles summarise the substance description and scientific properties from the registration dossier. Substance description gives an overview of the main substance identifiers, substance classification, on-going regulatory activities, main uses of the substance and which registrants manufacture and/or import the substance. Information in the Scientific properties section is structured by substance properties, further broken down into endpoints. Each endpoint includes three information blocks: Study results, type of study provided and summary data. Source data are the raw data which is the basis for the summaries in Infocards and brief profiles. Registration dossiers = IUCLID dossiers submitted to ECHA by companies who manufacture or import substances more than 1 tonnes/year. CoRAP list = Community rolling action plan. List of substances of potential concern that will be evaluated by Member States in the next three years. More information at http://echa.europa.eu/regulations/reach/evaluation/substance-evaluation/community-rolling-action-plan. Authorisation list = Substances that have been included in the Annex XIV of REACH. The use of these substances is not allowed unless an authorisation for the use is granted. More information at http://echa.europa.eu/web/guest/addressing-chemicals-of-concern/authorisation. Restriction list = Substances for which manufacturing, placing on the market or the use has been restricted. More information at http://echa.europa.eu/web/guest/addressing-chemicals-of-concern/restriction. Harmonised C&Ls = Substances for which classification and labelling has been harmonized throughout the EU. More information at http://echa.europa.eu/addressing-chemicals-of-concern/harmonised-classification-and-labelling. Approved active substances = Substances approved as active substances under the Biocidal Products Regulation. It is possible to get an authorisation for a biocidal product only for approved active substances. More information at http://echa.europa.eu/regulations/biocidal-products-regulation/approval-of-active-substances. PIC Annex I = Substances listed in the Prior Informed Consent Regulation Annex I. A consent of the recipient country is needed before these substances can be exported to them. More information at http://echa.europa.eu/regulations/prior-informed-consent-regulation. FURTHER READING: Information on registered substances: http://echa.europa.eu/information-on-chemicals/registered-substances. Registration dossiers CoRAP List Authorisation List Restriction List Harmonised C&Ls Approved Active Substances PIC Annex I Source Data

REACH registration by 2018 The registration of phase-in substances was staggered under REACH: deadlines were set for 1 December 2010, 31 May 2013 and 31 May 2018. The third deadline in 2018 is expected to have some very specific features.

REACH 2018 Third and last registration deadline for phase-in substances Concerns: Companies that manufacture/import substances between 1 to 100 tonnes/year and have pre-registered them What is new? Higher % of SMEs Many SMEs might consider becoming lead registrants for the first time Many small SIEFs/registrants alone in their SIEF Less information  need to generate new data Different levels of sector organisations New economical and political contexts 31 May 2018 is the last registration deadline for phase-in substances. Companies cannot postpone their registration decision any longer by reducing production/import volumes. After the deadline, companies who want to enter the market for phase-in substances have to submit an inquiry to ECHA to be able to join an existing registration. CMR substances (carcinogenic, mutagenic or toxic for reproduction) manufactured or imported more than one tonne/year had their registration deadline already earlier, on 1 December 2010.

REACH 2018 - 2 Experience proves: REACH registration is manageable! Thousands of companies have already done it since 2008 More than 5 600 registrations for the last deadline received, 16% from SME companies ECHA, the European Commission, national authorities and industry organisations are joining their forces to support companies! FURTHER READING: REACH registration statistics, including also specific information regarding the 2018 deadline is available here: http://echa.europa.eu/regulations/reach/registration/registration-statistics.

ECHA’s REACH 2018 Roadmap ECHA’s REACH 2018 Roadmap is addressed to ECHA’s stakeholders, i.e. it is not support material addressed to (SME) registrants. It documents the Agency’s commitment to critically review the REACH registration process from start to finish to enhance the process and to more effectively support companies with their obligations. The objective of the actions under the Roadmap is to give more targeted support to SMEs and inexperienced registrants.

Roadmap document Published on 14 January 2015 Consultation with stakeholders June–September 2014 Comments received from 26 organisations Documents ECHA’s activities planned for 2014-2018 Actions to support inexperienced and SME registrants Main focus in improving the readability and accessibility of support material Milestones revised on an annual basis; annual progress report published Must be complemented by Member State and industry actions for successful management of the 2018 registration deadline Feedback received: Eleven national helpdesks, eight stakeholder organisations, five Member State Competent Authorities and two Forum* members *The Forum = The Forum for Exchange of Information on Enforcement. The Forum is a body of ECHA; it coordinates the network of Member State enforcement authorities.

Roadmap structure: Seven phases Know your portfolio Find co-registrants Share data Assess hazards and risks Prepare your dossier To make the registration process more palatable for inexperienced and SME registrants, ECHA has split it into seven distinct phases. In reality many of these phases overlap or there may be a need to go back and forth between the phases as information is accumulated during the process. Submit your registration Keep your dossier up-to-date

Know your portfolio Identify if you need to register (role in the supply chain) and if yes, which substances in your portfolio need to be registered Identify and name your substances  accurate identification essential for data sharing and joint registration Familiarise yourself with the information requirements Plan your work and inform your downstream users Phase 1: Know your portfolio It is crucial that companies has a clear overview on their duties well ahead of the deadline so that they can plan how to carry out all necessary registrations by the deadline of 31 May 2018. Correct substance identification in REACH terms (constituents, additives and impurities identified) at this stage is important for the next phases in the registration process. Time needed for registering one substance varies a lot, from a few months if a registration already exists to up to three years depending on the complexity of the substance, size of the SIEF, availability of information and subsequently amount of information that needs to be generated etc. Substances to be registered may be crucial for the businesses of downstream users. Also for their sake it is good to decide on registration intentions well ahead of the deadline and inform customers accordingly.

Find your co-registrants Check your pre-registration Identify the lead registrant, or Find your co-registrants Discuss the sameness of your substance to share data and submit jointly Phase 2: Find your co-registrants REACH requires companies who register the same substance to do it jointly. This reduces costs, effort and contributes to REACH’s aim of reducing unnecessary testing on animals. If the substance has already been registered, a new registrant has to contact the existing SIEF (SIEF = Substance information exchange forum), typically through the lead registrant. If the substance has not yet been registered, pre-registrants must contact each other to confirm substance sameness and form the a SIEF. In this case, it’s important to be active early - this will allow the SIEF adequate time to get organised and prepare the registration.

Share data Organise your SIEF cooperation, or get active in the existing SIEF of your substance Share data to meet your information requirements Avoid unnecessary testing on animals Reduce costs of registration Negotiate costs in a fair, transparent and non- discriminatory manner Share the costs of common data Phase 3: Get organised in your SIEF You have to agree with your co-registrants on how you organise your SIEF, in other words, how to manage the SIEF administration. There is no mandatory way how the SIEF should operate. There are a lot of tips on ECHA’s website on what to consider, such as communication, decision making, and financial administration. SIEF has the main tasks of 1) facilitating the exchange of information to prevent duplication of studies and 2) agreeing on the classification and labelling of the substance. In practice, agreeing on the data and cost sharing model is central. European Commission’s Implementing Regulation on Joint Submission of Data and Data Sharing provide some guidelines on these: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32016R0009.

Assess hazards and risks Information required depends on tonnage and uses 1-10 tonnes: Possible reduced data requirements for less hazardous substances > 10 tonnes: chemical safety report needed Pay attention to data quality: relevance, adequacy and reliability Animal testing is the last resort - consider alternatives first Some long-term studies require a testing proposal Phase 4: Assess hazards and risks This phase is the core of the registration: the SIEF members consider what information they already have available and the SIEF decides on the strategy to fulfil the remaining information requirements. The SIEF needs also to decide whether or not to outsource this work or part of it. Reduced data requirements apply to low risk, low tonnage substances. Read more about this in ECHA’s Annex III Strategy (http://echa.europa.eu/documents/10162/2621167/echa_annex_iii_strategy_en.pdf). Practical support from ECHA on how to apply Annex III criteria is available at http://echa.europa.eu/information-on-chemicals/annex-iii-inventory. ECHA provides an IT tool, Chesar (chemical safety assessment and reporting tool), for free for conducting the chemical safety assessment and preparing the chemical safety report and exposure scenarios. The tool is available at https://chesar.echa.europa.eu/.

Prepare your dossier Prepare your technical dossier in IUCLID Identity of the registrant Identity of the substance Information on the substance’s intrinsic properties Information on use and exposure Companies preparing a member dossier without any opt-outs can do it on-line in REACH-IT Chemical safety report needs to be included if manufacture/import is at or above 10 tonnes/year Use of ECHA tool Chesar recommended ECHA Cloud Services is an option designed for SMEs to access IUCLID without the need to install the application Phase 5: Prepare your dossier IUCLID (International Uniform ChemicaL Information Database) is a software application to capture, store, maintain and exchange data on intrinsic and hazard properties of chemical substances. It is the software to prepare registration dossiers for REACH. ECHA provides it free of charge. IUCLID is available here http://iuclid6.echa.europa.eu/. ECHA Cloud Services is a secure online platform used to distribute ECHA’s IT applications in a cloud environment. See more at https://echa.europa.eu/support/dossier-submission-tools/echa-cloud-services.

Submit your registration Check and update the information that is relevant for registration in REACH-IT Carefully assess your SME status Set up or join the joint submission in REACH-IT Submit your registration dossier: first the lead registrant, then all co-registrants Follow up on the communication in REACH-IT Phase 6: Submit your registration REACH-IT is an IT tool that supports industry, Member State competent authorities and the European Chemicals Agency to securely submit, process and manage data and dossiers. More information is available here http://echa.europa.eu/web/guest/support/dossier-submission-tools/reach-it. SMEs benefit from reduced registration fees. Therefore the SME status is declared at the submission phase in REACH-IT and some supporting documentation needs to be provided. Wrongly declared SME status lead to an administrative charge and the balance to the correct fee to be paid. More information at http://echa.europa.eu/support/small-and-medium-sized-enterprises-smes/sme-fees-under-reach-and-clp. ‘One substance, one registration’ principle is enforced by ECHA at the submission phase: If there is an existing registration for a given substance, subsequent registrants are guided to join that registration if they are submitting outside it. REACH-IT is available at https://reach-it.echa.europa.eu/.

Keep you registration up-to-date Registration dossier is a living document! Duty to update the registration dossier if Regulatory decision New information on substance (properties, uses) Be proactive Consult ECHA’s Evaluation Progress Reports for most common anomalies in registration dossiers Follow regulatory developments for your substance on the ECHA website Phase 7: Keep your registration dossier up-to-date ECHA’s Evaluation Progress Reports can be found here: http://echa.europa.eu/web/guest/about-us/the-way-we-work/plans-and-reports Use PACT (Public Activities Coordination Tool) to follow the regulatory activities. It is available here: http://echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-concern/pact.

REACH 2018 Communication Awareness raising about REACH 2018 is important so that all companies having registration obligations start early enough. This section introduces ECHA’s REACH 2018 web pages which are a one-stop-shop for the Agency’s REACH 2018 advice. It also introduces the REACH 2018 Communicators’ Network - an informal gathering of communicators from Member States, the Enterprise Europe Network and industry organisations - to enhance awareness about REACH 2018.

REACH 2018 website: http://echa.europa.eu/reach-2018 Simple language Available in 23 languages Structured around the registration workflow ECHA support material for each step organised in three layers of complexity Getting started Essential reading Going deeper Advance notice on upcoming issues ECHA asks all stakeholders to join and promote the REACH 2018 web pages as the central point of REACH 2018 information and help.

Notice the following features for each phase Left-hand panel with easy navigation between all REACH 2018 phases News relevant for the phase Practical examples and case studies for a phase

Support material in three categories Getting started: An overview of what the phase is about Essential reading: More about the content to help you decide e.g. if you need to outsource the work Going deeper: How to carry out the tasks For each phase, support material has been organised in three layers of increasing complexity to allow a structured entry into the topics.

REACH 2018 Communicators’ Network Set up to: Plan and coordinate awareness raising activities Help to produce and distribute material in all EU languages Collect feedback from target audiences Measure impact of coordinated activities ECHA, European Commission, Member States, industry organisations, Enterprise Europe Network local organisations Active since early 2015 The network includes members from the Member States, industry organisations, the Enterprise Europe Network and the European Commission and ECHA. Its task is to coordinate awareness raising activities for the last deadline of 31 May 2018. It works on a voluntary basis, and mainly virtually. The aim is to coordinate communication activities across the EU Member States and organisations. ECHA is constantly looking for new not-for-profit members to join the network. More information at http://echa.europa.eu/press/reach-2018-communicators-network.

Joint activities around phase launches What ECHA is doing to promote each of the REACH 2018 Roadmap phases Press release in 23 EU languages One hour webinar outlining the content of the phase Special e-News Articles in the ECHA Newsletter LinkedIn posting Twitter posting Sharing all of these with the REACH 2018 Communicators’ Network  All these can be used by ECHA’s stakeholders in their own communication

Awareness raising through various audiences REACH 2018 leaflets available Generic leaflet Leaflet targeted to workers’ representatives (jointly with ETUC) Both available in 23 languages here http://echa.europa.eu/reach-2018. In addition, there is a leaflet for non-EU companies (in English) outlining what non-EU companies can do to support their European customers to fulfil their obligations under REACH and CLP.