REACH 2018 Prepare your registration as a IUCLID dossier

Purpose of this presentation This presentation, with notes, was prepared by ECHA, the European Chemicals Agency, to assist you in preparing a presentation about REACH 2018, i.e. the 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 phase 5 (Prepare your registration as IUCLID dossier) of ECHA’s REACH 2018 Roadmap. It belongs to a series of presentations relating to REACH 2018, which are on ECHA’s 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 2017

Phase 5: Prepare your registration as a IUCLID dossier Activities: Choose the best way for you to access IUCLID Create your substance dataset Fill in the data for your substance Create your registration dossier Check your registration dossier These are the five key activities in this phase of your preparations for registration.

Get IUCLID Online dossiers IUCLID Cloud IUCLID 6 Directly in REACH-IT No installation needed If your substances are registered as a member of a joint submission IUCLID Cloud Available online in ECHA Cloud Services For SMEs IUCLID 6 In all other cases, you can install the IUCLID 6 software Available for free on the IUCLID 6 website Desktop or Server versions IUCLID is an IT application to manage information on chemicals. It can be used in three different ways, all based on IUCLID 6 technology. Under certain circumstances, you can submit your dossier directly through REACH-IT, “online”. This applies if you are a member registrant who agreed with the information submitted in the joint part of the registration. For SMEs, IUCLID is made available through ECHA Cloud services. This takes away the burden of managing the IT aspects related to the software, such as installation and software updates. You can also choose to install IUCLID on your computer. You can download IUCLID for free from ECHA’s website and installation is very easy. Download the latest version, which is version 6. If you exchange files with registrants who registered for the previous deadlines, keep in mind that registrations now need to be prepared in IUCLID 6.

IUCLID terminology Legal entity: (natural or) legal person having obligations under REACH Reference substance: document containing the main substance identifiers (IUPAC name, CAS and EC numbers) Endpoint: outcome of fulfilling a certain information requirement ≈ property of the substance Universal unique identifier (UUID) When using IUCLID you will encounter several terms, such as: Legal entity. This is a document containing the details of the organisation using IUCLID. Under REACH, this will represent a natural or legal person who has to register a substance. The information given in IUCLID is for your own record-keeping as ECHA will use the information given in ECHA accounts or REACH-IT instead. By default, this legal entity is not included in your dossier. The Reference Substance: This is a document containing the key identifiers of your substance or its constituents such as the IUPAC name, CAS and EC numbers. Endpoints which represent properties of the chemicals to be registered and for which information is required to be communicated to ECHA. The endpoints information is collected IUCLID substance dataset. Each document in IUCLID is tagged with a universal unique identifier (UUID) that allows you to unequivocally identify a precise piece of information. [Note: Terms in bold in this slide, and in the notes should not be translated]

Create your substance dataset Specify which substance you will register You can get the substance dataset from the lead registrant or create your own The substance dataset specifies which substance the registration dossier will be for. You can edit the substance dataset at any time. Dossiers are created from the dataset, and they cannot be edited once created. You can ask for the substance data set from the lead registrant but you can also create your own.

Content of a substance dataset Section 1: Substance identification, composition(s), analytical information [Note: In this and following four slides only the blue box content to be translated]

Content of a substance dataset Section 2: Classification and labelling, PBT assessment

Content of a substance dataset Section 3: Manufacture, use and exposure

Content of a substance dataset Section 4-7: Study summaries in endpoint records (substance properties)

Content of a substance dataset Section 11 and 13: Guidance on safe use and assessment reports

Fill in the data for your substance Every co-registrant of the joint submission: Substance identity, including impurities Tonnages of the last three years Uses and conditions of use of the substance through its life cycle Lead registrant: Substance Identity Profile (SIP) Physico-chemical, toxicological, and ecotoxicological properties Classification and labelling information Once you have created your substance dataset, you can fill in the data that you have gathered. Each co-registrant needs to submit their own registration as part of the joint registration and your registration dossier needs to contain: the identity of your substance as manufactured/imported it, including concentration ranges and impurities the tonnages you have manufactured or imported during, at least, the last three years the uses and conditions of use in your supply chain throughout the lifecycle of the substance As a lead of a joint registration, your IUCLID dossier will need to contain: the substance identity profile. It is expected to specify the boundaries of the substance which the registrants agreed to cover with the data jointly submitted. the hazard data gathered by the SIEF: the physico-chemical properties, and toxicological and ecotoxicological data If some data is not provided, a justification needs to be included the classification and labeling of the substance derived from the gathered hazard data

Fill in the data for your substance Every co-registrant or the lead on their behalf For 1-10 tonnes per year: Guidance on safe use For 10-100 tonnes per year: Assessment of the persistent, bio-accumulative, and toxic properties of the substance (PBT assessment) Chemical safety report (CSR) Members who will submit own data or classification and labelling Data and justification for opting out for the data Some data can be submitted either jointly or individually, as agreed in the SIEF. As a member you can, under certain conditions, submit data in your own registration dossier rather than in the dossier of the lead registrant: You need to provide a justification why you are opting out from the joint submission of data. Make sure that the dossier is not incomplete or incompliant. If you are joining a SIEF and buying a letter of access for a substance that is already registered, it is important that you check that: your substance fits the substance identity profile of the registration, meaning that your substance is within the boundary composition and the data set fits your substance if there is a joint CSR, that your uses and conditions of use are covered in it You get enough information from the lead registrant to be able to recommend relevant safety measures and prepare your safety data sheets

Fill in the data: confidential business information (CBI) Confidentiality claims are reported in IUCLID for: Company name Uses of the substance Tonnage band, etc.… Need a comprehensive justification Subject to a fee Claims and justifications will be assessed If accepted, the information will not be published on the ECHA website Most of the information in your registration dossier will be published on ECHA’s website. Some parts, such as the name of your company and the uses of the substance, will be published unless you have claimed them confidential. You will need to indicate in IUCLID that you do not wish this information to be published. You will then need to enter a comprehensive justification in IUCLID and pay the fee in addition to the registration fee. After registration, ECHA will assess all your confidentiality claims. Useful links: https://echa.europa.eu/regulations/reach/registration/publishing-information-from-dossiers

Create your registration dossier Create dossier = read-only snapshot of your data to be submitted to ECHA for substance Choose the correct type of registration Lead or member dossier Tonnage band (1-10 or 10-100 tonnes per year) Full or intermediate (under strictly controlled conditions) When you have filled in all your data you can create a dossier.

Check your registration dossier Use the functionalities of IUCLID to check that all needed information is included in the dossier Validation Assistant: helps ensure that your dossier can be accepted as complete when you submit it (can also be used on the dataset, i.e. before the creation of the dossier) Dissemination preview: shows which information from your dossier will be made available to the public on ECHA’s website The last step before you are ready to submit your dossier is to check the dossier you have created. IUCLID has two specific functionalities to help with that. The most important functionality is the validation assistant. It helps you check if your dossier can be accepted as complete when you submit it. You can also use the validation assistant on your dataset before you create the dossier. Note that the validation assistant does not include the manual check that ECHA will do. The dissemination preview shows which information from your dossier will be made available to the public on ECHA's website. Use these functionalities and determine if you need to make changes to your dataset and create a new dossier. Useful links: Information on manual verification at the completeness check: https://echa.europa.eu/manuals

Few tips on IUCLID 6 In the table of contents of your dataset, select a view that suits your substance tonnage, and your role in the joint submission Use the Validation Assistant to check your substance dataset before creating a dossier; and then use it afterwards to check the dossier Right-click to access IUCLID 6 menu options

Few tips on IUCLID 6 Need help while filling in a field? Press F1 to access the help system Avoid retyping information: use the IUCLID 6 inventories and templates Some free-text fields come with their own text template that helps you fill out the field Contact ECHA if you need support for IUCLID use

IUCLID 6 website Subscribe to the latest news on IUCLID 6 Access the available documentation and download the version you need After creating a user account, you can subscribe to the news notifications. In most cases, you will want to download and install the desktop version of IUCLID. This version is for single users accessing IUCLID on their own computer. Useful links: https://iuclid6.echa.europa.eu/

ECHA Cloud Services Access from ECHA’s website Always work on the latest version of the application Reduced risks of data loss (backups managed by ECHA) Facilitate working anywhere (easier remote access) and delegation to consultants Possibilities for better online support No cost for users managing installations and hardware Data is more secure because of reduced number of local copies Access from ECHA’s website Aimed for SME users to prepare registration dossiers for REACH 2018 deadline Work fully on a web browser without installing anything locally 24/7 availability from anywhere in a secure cloud environment Trial version available for testing out the application If you are an SME preparing your registrations for the REACH 2018 deadline, consider using ECHA Cloud Services to reduce the need for technical support Useful links: https://echa.europa.eu/support/dossier-submission-tools/echa-cloud-services

Take away messages Choose the IUCLID version that is best for you Foresee sufficient time to fill in data and ensure that your dossier is fit for submission Support is available at https://echa.europa.eu/reach-2018 Contact ECHA if you need further support