REACH-IT News Flash No 12-A

REACH IT on 1 June 2008

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REACH-IT News Flash No 12-A

30 May 2008

Theme: Updated Newsflash re: REACH-IT

Content:

0. Introduction

Editor’s notes.

1.IT system for REACH on 1st of June 2008

1.1Pre-registration – Pre-SIEF

1.1.1Available in June

1.1.2Impact

1.1.3Cefic Recommendations

1.2Inquiry

1.2.1Available in June

1.2.2Impact

1.2.3Cefic Recommendations

1.3Registration

1.3.1Available in June

1.3.2Impact

1.3.3Recommendations

1.4PPORD Notifications

1.4.1Available in June

1.4.2Impact

1.4.3Recommendations

2.How to get more information

3. Web conferences

4. Glossary

Editor’s notes.

This newsflash contains news on development and implementation of IT systems for REACH. This publication is distributed regularly to Cefic Members, and is available on / REACH-IT / Information Folder / Newsflash REACH-IT / …...... Editor: Jack Wille, Cefic, Tel. +32-2 676 74 08; Email:
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 (, tel. +32-2-676 7408).

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Printed 19/05/2019, 8:57 AM

REACH-IT News Flash No 12-A

REACH IT on 1 June 2008

  1. 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

1.1.1Available 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).

1.1.2Impact

  • 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:

 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 XML[1]) 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.

1.1.3Cefic 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:

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:
  • 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.
  • 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.
  • Reporting on the ‘real’ Legal Entity cannot be provided by means of the LE UUID.

1.2 Inquiry

1.2.1Available in June

  • The INQUIRY module won’t be available in REACH-IT on 1st of June.
  • The dossier ‘template’ does not exist in IUCLID5.
  • A user manual is in preparation to explain how to use IUCLID 5 to prepare the dossier.

1.2.2Impact

  • 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.

1.2.3Cefic 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:

1.3 Registration

1.3.1Available 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!).

1.3.2Impact

  • 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.

1.3.3Recommendations

  • 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 (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:

1.4 PPORD Notifications

1.4.1Available 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.

1.4.2Impact

  • 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)

1.4.3Recommendations

  • 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:

2. How to get more information

Information on temporary procedures will be

  • Made available on ECHA web site:
  • 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

Release notes on the REACH-IT software implementations will be available at 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 (Friday) / 11:00 – 12:30 h. (Central European Time – CET)
13 June 2008 (Friday) / 9:30 – 11:00 h. (Central European Time – CET)

(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 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
UVCB / Substances of unknown or variable composition, complex reaction products or biological materials
VAS / Vertebrate Animals
vPvB / Very Persistent and very Bioaccumulative
WF / Work Flow
XML / Extended Markup Language

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