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: [email protected].
•
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
2
Phase 5: Prepare your
registration as a IUCLID dossier
Activities:
1.
2.
3.
4.
5.
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
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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
• Available online in
ECHA Cloud Services
• No installation
needed
• For SMEs
• In all other cases, you
can install the IUCLID
6 software
• Available for free on
the IUCLID 6 website
• Desktop or Server
versions
4
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)
Create your substance dataset
• Specify which substance you will register
• You can get the substance dataset from the lead
registrant or create your own
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Content of a substance dataset
Section 1: Substance
identification,
composition(s), analytical
information
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
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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
13
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
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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)
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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
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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
ECHA Cloud Services
•
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
Always work on
the latest
version of the
application
Data is more
secure because
of reduced
number of local
copies
Reduced risks
of data loss
(backups
managed by
ECHA)
No cost for
users managing
installations
and hardware
Facilitate
working
anywhere
(easier remote
access) and
delegation to
consultants
Possibilities for
better online
support
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