Cefic REACH-IT News Flash

REACH-ITREACH-ITOne of REACH-IT News Flash No 12-A 30 May 2008

Theme: Updated Newsflash re: REACH-IT Content: 0. Introduction

EDITOR’S NOTES. 1

1. IT SYSTEM FOR REACH ON 1ST OF JUNE 2008 3

1.1 Pre-registration – Pre-SIEF...... 3 1.1.1 Available in June...... 3 1.1.2 Impact...... 3 1.1.3 Cefic Recommendations...... 4

1.2 Inquiry...... 4 1.2.1 Available in June...... 4 1.2.2 Impact...... 5 1.2.3 Cefic Recommendations...... 5

1.3 Registration...... 5 1.3.1 Available in June...... 5 1.3.2 Impact...... 5 1.3.3 Recommendations...... 5

1.4 PPORD Notifications...... 6 1.4.1 Available in June...... 6 1.4.2 Impact...... 6 1.4.3 Recommendations...... 7

2. HOW TO GET MORE INFORMATION 7

3. WEB CONFERENCES 7

4. GLOSSARY 9

Editor’s notes. This newsflash contains news on development and implementation of IT systems for REACH. This publication is distributed

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regularly to Cefic Members, and is available on http://ecefic.cefic.org / REACH-IT / Information Folder / Newsflash REACH- IT / …...... Editor: Jack Wille, Cefic, Tel. +32-2 676 74 08; Email: [email protected] Disclaimer The information contained in ‘IT Architecture for Industry to support REACH’ is intended for guidance only and whilst the information is provided in utmost good faith and has been based on the best information currently available, is to be relied upon at the user’s own risk. No representations or warranties are made with regards to its completeness or accuracy and no liability will be accepted for damages of any nature whatsoever resulting from the use of or reliance on the information. Copyright Copyright © 2006 by Cefic (AISBL), all rights reserved except for the Cefic members. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, mechanical, photocopying, recording or otherwise, without prior written permission of the owner. Please apply to Jack Wille ([email protected], tel. +32-2-676 7408).

of 11 Printed 09/04/2018, 1:18 PM 0. Introduction. Based on latest news from ECHA about the status of REACH-IT and related procedures, the Newsflash no. 12 (distributed 23 May) has been updated to reflect most recent developments. Modified text is highlighted in yellow. .

1. IT system for REACH on 1st of June 2008 Some temporary procedures have been put in place by ECHA in order to ensure the compliance of Industries and MSCA with the REACH regulation. All REACH-IT modules that won’t be available on 1st of June are concerned by those temporary procedures.

1.1 Pre-registration – Pre-SIEF

1.1.1 Available in June . Sign-up process (Legal Entity and User) The sign-up module will be available in REACH-IT on 1st of June. Important: The Legal Entity UUID has to be referenced in all temporary procedure communication to ECHA

. Third Party Representative signing-up The Third Party Representative is considered to be a company, and have also a UUID (available 1 June).

. Single/on-line pre-registration The on-line pre-registration module will be available in REACH-IT on 1st of June.

. Bulk Pre-registration The bulk pre-registration module will be added later (ECHA: ‘…shortly after 1 June…’) – operational as soon as proved that it is working according to requirements.

. Pre-SIEF The Pre-SIEF web page shows data from Companies which pre-registered a particular substance (available 1 June).

. Feedback from the Agency will be made available via messages in an internal message box (available 1 June).

1.1.2 Impact . The sign-up process shall be done in REACH-IT.

. Pre-registration data entry through the on-line pre-registration can be done in REACH- IT. It means that company users can enter the Pre-Registration data via the web-based interface into the REACH-IT Workflow system; this implicates entry of Substances one by one.

. If you have more than a few substances to pre-register we would recommend you using the other options. Those options are announced by ECHA to be available later, and added in the system after 1st of June:

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 Use of the IUCLID5 Plug-in tool developed to extract data from IUCLID5: This system allows extraction of pre-registration data from IUCLID5 to prepare a pre- registration XML1) file, either for one Substance (Single upload) or for a number of Substances (Bulk upload. The single and bulk XML files can be submitted to the European Chemicals Agency using the REACH-IT web application. The date when this will be available will be announced by ECHA soon.  A last option has been developed jointly by Cefic and CONCAWE. It is an Excel- XML transfer tool. It supports bulk submission of Pre-registration data only. As a first step, Users will populate Pre-registration data in a pre-formatted Excel spreadsheet. In the next step, conversion will take place from Excel to the published ECHA standard data format (XML) and a submission report will be created as soon as it has gone through a validation step with the REACH-IT system.

1.1.3 Cefic Recommendations . Sign-up in REACH-IT

. Rely on IUCLID 5 to be the current “master” for your own company information.

. The unique identifier – your UUID – is the main key of both IUCLID5 and REACH-IT, and is a key for unambiguous identification of your company when you submit a dossier later.

. To make sure that your company is identified in the same way in IUCLID5 and in REACH- IT, use your LEO data, by uploading the LEOX file to REACH-IT. In both systems, you will then have the SAME UUID.

. For more information on ECHA website: http://echa.europa.eu/reachit/createaccount- it_en.asp

1.1.4 Legal Entity implementation in REACH-IT . It became clear that a pre-registration submission (or on-line data entry) has to be done for each Legal Entity / Role combination, e.g. if a Legal Entity is a Manufacturer / Importer and at the same time also an Only Representative (OR), two different Legal Entity UUIDs are needed. . In addition, as result of the rule that an OR has to submit a separate (pre)-Registration dossier for each non-EU Manufacturer, a unique Legal Entity UUID is needed for each OR / non-EU Manufacturer combination. . Consequences: o Be aware of this situation to occur if you create Legal Entities in IUCLID5 / REACH-IT: Legal Entity in REACH-IT will not reflect the ‘real’ Legal Entity any longer, if those situations occur. o The name of the Legal Entity may be used to differentiate between the different Legal Entities, e.g. ‘Legal Entity ABC – MI’, ‘Legal Entity ABC – OR’. Assure you have naming conventions to be applied for Legal Entity names. o Reporting on the ‘real’ Legal Entity cannot be provided by means of the LE UUID.

1.2 Inquiry

1.2.1 Available in June . The INQUIRY module won’t be available in REACH-IT on 1st of June.

. The dossier ‘template’ does not exist in IUCLID5.

1 XML is a common standard for exchange of data between computer systems.

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. A user manual is in preparation to explain how to use IUCLID 5 to prepare the dossier.

1.2.2 Impact . Inquiry dossier has to be created using IUCLID5

. Companies have to download the ‘Inquiry information requirements form’ and ‘Submission form’ from ECHA website.

. The dossier needs to be submitted (with those forms) to ECHA by email or CD-ROM.

1.2.3 Cefic Recommendations . In IUCLID5, enter information in the appropriate sections - Notifier identification (section Legal Entity) - Substance identification (sections 1.1, 1.2, 1.4)

. Clearly specify your Legal Entity UUID on each submission form . For the list of information requirements which would require new studies, the form has to be used. . For more information on ECHA website: http://echa.europa.eu/reachit/inquiry_en.asp

1.3 Registration

1.3.1 Available in June . The Registration module won’t be available in REACH-IT on 1st of June.

. The dossiers can be prepared in IUCLID 5 – the functionality exists already.

. The individual registration is possible (non-phase-in!).

1.3.2 Impact . A submission form should be filled in by companies. This form can be downloaded from ECHA website.

. The dossier will be submitted by email or CD ROM to ECHA, with the submission form.

. The Technical Completeness Check will be done manually by ECHA.

. ECHA will send an ‘acknowledgment of receipt’ with the submission number and the submission date via email and letter.

. ECHA verify fee payment prior to send Registration number via email and letter.

. This temporary process should be the current process until the dossier submission is available in REACH-IT.

1.3.3 Recommendations . Rely on IUCLID5 to prepare dossiers.

. Fill in carefully the submission form in order to ensure that the dossier is properly identified (UUID), the fees will be properly calculated, your company can handle the

invoice via PO number,…. Note: Clearly specify your Legal Entity UUID on each submission form

. Use functional mailbox (with attached files) or send CD-ROM with the submission form to ECHA by express courier.

. Keep copy of dossiers and copy of submission documents by courier/by email in order to proof your compliance with REACH regulation.

. ECHA recommends not sending Joint Submission dossier until the functionality in REACH-IT is available – for a better and efficient management of the dossiers.

. For early Joint Submission dossiers, please contact ECHA directly, by sending email to [email protected] (Available from 1 June).

. For any problems related to confirmation of receipt, invoices, registration number, please contact ECHA via email (see ECHA website).

. For more information on ECHA website: http://echa.europa.eu/reachit/registration- it_en.asp

1.4 PPORD Notifications

1.4.1 Available in June . The PPORD module won’t be available in REACH-IT on 1st of June.

. The dossiers can be prepared in IUCLID 5 – the functionality exists already.

. A user manual is in preparation to explain how to use IUCLID 5 to prepare the dossier.

1.4.2 Impact . Use of IUCLID 5 to prepare the PPORD notification

. Enter information in appropriate sections: . Identify the notifier (section Legal Entity), . Identify the substance (section 1.1, 1.2, 1.4) . C&L (section 2.2) . List of customers (section 1.8) . Estimated quantity and/or information of PPOR programme (section 1.9)

. Create the dossier by using the PPORD dossier template.

. ECHA will send an ‘acknowledgment of receipt’ with the submission number and the submission date via email and letter.

. ECHA verify fee payment prior to send Registration number via email and letter.

. Notification number/notification date will be communicated to the MSCA(s) concerned.

. PPORD notification will be communicated by ECHA to MSCA on request

. The notification will be posted on CIRCA (1 folder per MSCA, only accessible by this MSCA)

1.4.3 Recommendations . Rely on IUCLID 5 to prepare PPORD dossiers.

. Clearly specify your Legal Entity UUID on each submission form

. Send via email to ECHA’s functional mailbox (with attached files) or send CD-ROM with the submission form by registered mail. Note: Officially PPORD dossiers have to be received by ECHA ultimately 2 June 2008 !!. However, PPORD dossiers which have a time stamp / post stamp of 2 June or before will be considered by ECHA to be received in time: . When you send by registered mail, make sure that the post stamp reflects a date equal or before 2 June 2008. . When you send by email, make sure you send it before or on 2 June 2008.

. Keep copy of dossiers and copy of submission documents by courier/by email in order to proof your compliance with REACH regulation.

. Read carefully the next detailed information that should be published soon on ECHA website.

. For any problems related to confirmation of receipt, invoices, notification number, please contact ECHA via email (see on website).

. For more information on ECHA website: http://echa.europa.eu/reachit/ppord_en.asp

2. How to get more information Information on temporary procedures will be . Made available on ECHA web site: http://echa.europa.eu/reachit_en.asp . Communicated to Industry Associations . Communicated to Member States Competent Authorities

If you would like to receive REACH(-IT) News alerts, send your email address to [email protected]

Release notes on the REACH-IT software implementations will be available at https://reachit.echa.europa.eu/ as of 1 June.

A specific section will be created on ECHA web site for each process . Workflows will be explained . Links with detailed instructions

Cefic members will be informed by Newsletters and e-Spotlight. Cefic members can also call Cefic workgroup members for any question.

3. Web conferences During June 2008, 2 web conference sessions have been scheduled at which you may participate, to obtain more background information on subjects which have been described in this newsflash:

6 June 2008 11:00 – 12:30 h. (Central European Time – CET) (Friday)

13 June 2008 9:30 – 11:00 h. (Central European Time – CET) (Friday) (Please connect 5-10 minutes before the conference starts). Key topic for this web conference: “REACH IT on 1 June 2008”

If you would like to participate, please send email note to Nathalie Allard, at [email protected] indicating: - Date of web conference to participate - Name(s) of persons who will attend the web conference - Company name - Email address to send web conference invitation to

After registering, you will receive dial-in information to attend the web conference.

4. Glossary

BOM Bill of Material C&L Classification and Labelling CAS# Chemical Abstracts Service number CBI Confidential Business Information CMR Carcinogen, Mutagen, or Reproductive Toxicant CRM Customer Relationship Management CSA Chemical Safety Assessment CSR Chemical Safety Report DBMS Database Management System DG ENT Director General Enterprise DG ENV Director General Environment DNEL Derived No Effect Level DU Downstream User DUNS D&B Unique Numbering System EBW Exposure Based Waiving EC European Commission ECB European Chemicals Bureau EChA or ECA European Chemicals Agency EC-Number EINECS and ELINCS Number (see also EINECS and ELINCS) EIF Entry into Force EINECS European Inventory of Existing Commercial Substances EIO Entry Into Operation ELINCS European List of notified Chemical Substances EM Environment Management EP European Parliament ERP Enterprise Resource Planning ES Exposure Scenario E-SDS Extended Safety Data Sheet EU European Union GES Generic Exposure Scenario GHS Global Harmonised System GLP Good Laboratory Practice HPV High Production Volume HSE Health, Safety and Environment HW Hardware

ICCA International Council of Chemical Associations IH Industry Hygiene IT Information Technology IUCLID5 International Uniform ChemicaL Information Database IUPAC International Union for Pure Applied Chemistry JRC Joint Research Centre JRE Java Runtime Environment JS Joint Submission LE Legal Entity LEO Legal Entity Object LEOX Legal Entity Object XML LR Lead Registrant M/I Manufacturer/Importer MS Members states MSDS Material Safety Data Sheet MSCA Member States Competent Authorities MNF Manufacturing NCD New Chemicals Database NLP No longer polymers OC Operating Conditions OCC Optimistic Concurrency Control OECD Organisation for Economic Co-operation and Development OH Occupational Health OR Only Representative OSOR One Substance, One Registration PBT Persistent, Bioaccumulative and Toxic substance PEC Predicted Effect Concentration(s) PNEC(s) Predicted No Effect Concentration(s) PPORD Product and Process Orientated Research and Development PPP Plant Protection Products (Q)SAR Qualitative Structure Activity Relationship REACH Registration, Evaluation, Authorisation and Restriction of Chemicals R&D Research & Development REIF REACH enters into force RIP REACH Implementation Project RMM Risk Management Measure RSS Robust Study Summary

SAICM Strategic Approach to International Chemicals Management SAT System Acceptance Test SC Supply Chain SCC Supply Chain Communication SDS Safety Data Sheet SE Benefits Socio-Economic Benefits SEA Socio Economic Analysis sES specific Exposure Scenario SFF SIEF Formation Facilitator SIAM SIDS Initial Assessment Meeting SIAR SIDS Initial Assessment Report SIDS Screening Information Data Set SIEF Substance Information Exchange Forum SIMS Substance Inventory Management System SME Small and Medium sized Enterprises SNIF Summary Notification Interchange Format SPORT Strategic Partnership on REACH Testing SRM Supplier Relationship Management SVHC Substances of Very High Concern SW Software TF Task Force TGD Technical Guidance Document TPR Third Party Representative UUID Universal Unique Identifier UVC Substances of poorly defined, complex or variable composition Substances of unknown or variable composition, complex reaction products or UVCB biological materials VAS Vertebrate Animals vPvB Very Persistent and very Bioaccumulative WF Work Flow XML Extended Markup Language

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