countdown to registration member joint submissionmagic wand: allows you change information in...
TRANSCRIPT
Countdown to Registration Member Joint Submission
23rd September 2010
Overview
Introduction
Part I: Step-by-step approach to completing the member dossier and running plug-ins
Part II:Submission activities including joint submission, ECHA dossier checking and post-submission
Part III: Q & A and IUCLID demo
Recap on Registration
Responsibility for management of risks
with Manufacturer/Importer (M/I)
Registration requires M/I to:
Generate data on substances
Use data to assess risks
Develop risk management measures
Submit the Registration Dossier to the European Chemicals Agency (ECHA)
Information Exchange - SIEFs
Substance Information Exchange Forum
Formed by companies wishing to register the same substance
Facilitate data sharing and avoid duplication of studies
Agree Classification and Labelling
Share and collate information for registration
Leads to a single joint submission for each substance
No option to opt out but can decide how active to be
Roles in the SIEF – Lead Registrant
Appointed by consent of all members
ECHA must be informed of appointment
Acts with agreement of other registrants and submits the joint dossier
Most likely to submit their registration before the 30 Nov 2010 deadline
5
Roles in the SIEF – Member Registrant
Will register by deadline, but not the LR
Will submit own member dossier, after the joint submission
Request missing information from other SIEF members
Identify needs for further studies
Arrange to perform identified studies (where TP not required)
Agree on classification and labelling
SIEF Participation and Data Sharing
Joint submission dossier must contain:
Robust study summaries
Testing proposal (if required)
Classification and labelling
If information has been reviewed by assessor
Joint submission dossier may contain:
Guidance on safe use
Chemical safety report
SIEF Participation and Data Sharing
Member registrant must submit separately:
His identity
Identity of the substance
Information on manufacture and use(s)
Request as to which information should not be made publicly available
The lead registrant must submit the joint submission dossier first, followed by the dossiers of the other members
Opt-Out
Opt-out of JS under certain circumstances:
If disproportionately costly
If would lead to disclosure of confidential business information
If disagreement with LR on selection of information
Must be justified and documented
Higher fee (individual rather than joint)
Priority for compliance check by ECHA
Data Sharing and Joint Submission
One Substance
One SIEF
One Lead Registrant
One Joint Submission
IT Tools
IUCLID 5 IUCLID 5 is an IT application built to enter, store and report information on hazardous properties of chemicals
REACH ITOnline system used by industry for the secure submission of data and dossiers on chemicals to ECHA
Step-by-Step
Steps to complete the member dossier:1. Gather required information
2. Create the substance dataset
3. Create the dossier
4. Join the Joint submission
5. Submit the Dossier to ECHA
Gathering Data I
1. Identity of the registrant• Name, address, email, phone & fax
• Role in the supply chain (may be multiple)
• Pre-registration number
• LEO from REACH-IT must be synchronised with IUCLID
• SME status
Gathering Data II
2. Identity of the substance/composition • IUPAC name
• EC and/or CAS number
• Source and process (UVCB)
• Impurity and/or additive information
3. Manufacture and Uses• ‘Technological process’ for manufacturers only
• ‘Estimated quantities’ for all actors
• ‘Sites’ for manufacturer’s production sites only
Gathering Data III
• ‘Form in the supply chain’ must be completed (available as substance, substance in mixture, substance in article)
• At least one use must be filled in - your own use(s) and those intended by an actor in the supply chain or communicated to you
• Use Descriptors
4. Exposure information• Required for substances in the 1-10 T/Y band
• Substances ≥ 10 T/Y: exposure information is submitted in the CSR (own or joint)
Part I
Create the Substance Dataset
Create the Substance Dataset
Introduction
General Information
Manufacture, use and exposure
Chemical Safety Report
Dataset Checks (TCC tool)
Create the Dossier
Export the Dossier
Create the Substance Dataset
Introduction
General Information
Manufacture, use and exposure
Chemical Safety Report
Dataset Checks (TCC tool)
Create the Dossier
Export the Dossier
IUCLID 5
IUCLID 5 is the tool for industry to fulfill their REACH requirements
Available free of charge
The only tool for preparing the dossier
Download IUCLID 5.2
Due to compatibility issues with other programmes, you must download IUCLID 5.2 available at http://iuclid.echa.europa.eu/
Not an online tool
IUCLID Account Set-up
Create an account (internal administrator)
Import your legal entity object (LEO) from REACH-IT into IUCLID
Import the EC inventory and reference substance inventory (will download at step 7)
Create user accounts (administrator login does not support working in IUCLID)
Execute downloads and finish
Icons Explained
Legal Entity: Imported from REACH-IT LEO Legal Entity Site
Substance Dataset Reference Substance
Repeatable Block (hide; move block down; up; create; delete)
Golden Link: links information from local and downloaded inventories
Magic wand: allows you change information in automatically filled boxes
Mixture Dataset
Paper clip: allows you to attach files (word processing or pdf)
Confidentiality flag: fields that you can hide from public dissemination (cost)
Terminology Explained
Substance dataset: central core of information stored in IUCLID linking all entered data related to the substance
Reference substance: obtained from the inventory, links all known identifiers with the substance
Dossier: final information file, contains the substance dataset, legal entity, reference substance and dossier header
Dossier Header: the information entered by you while creating the dossier
IUCLID Main Page
Create the legal entity site (manufacturers only)
Select ‘New’
Create the legal entity site (manufacturers only)
Create the legal entity site (manufacturers only)
At a minimum
provide name,
town,
city and
country.
Substance Dataset Creation
Select ‘New’
Substance Dataset Creation
Substance Dataset Creation
If you select the
template before
you enter data, it
will colour code
required endpoints
Substance Dataset Creation
Expand and Collapse the Tree
Substance Dataset Creation
Create the Substance Dataset
Introduction
General Information1.1 Identification
1.2 Composition
1.3 Identifiers
1.4 Analytical Information
(1.5 Joint Submission)
(1.7 Suppliers)
1.1 Substance Identification
The legal entity’s role in the supply chain
The reference substance
The substance composition
The contact details of the IUCLID owner
Identification
A Note on Confidentiality
Confidentiality may be selected for certain information fields based on:
Confidential Business Information (CBI), Intellectual Property (IP), Not Publically Available (no PA)
Certain information such as substance identification (see Art 119(1))cannot be made confidential
Each claim for confidentiality will cost the dossier submitter and a justification must be provided
Identification
IdentificationIdentification
IdentificationIdentification
If no substance
appears you must create
your own reference
substance by clicking on
‘New’.
IdentificationIdentification
1.2 Composition
Substance identity crucial
Substance, including any impurities or additives
Composition must be fully described
If a mono-constituent the constituent must correlate with the (reference) substance in section 1.1
Multiple constituents added using repeatable blocks (e.g. multi-constituent)
Impurities ≥ 1% must have at least one chemical identifier
If identifiers unknown, type ‘unknown’ under IUPAC name
Composition
Create a repeatable block
Composition
At least 1 constituent must
be provided
Composition
1.3 Identifiers
Links registration with the pre-registration or inquiry number
A regulatory programme must be selected and pre-registration or inquiry number entered
Identifiers
Fill in pre-registration
(or inquiry) number
1.4 Analytical Information
What’s needed? Spectral data (UV, IR, NMR, MS)
HPLC and GC
Description of the analytical methods sufficient to allow the methods to be reproduced
Analytical Information
Analytical methods (type or attach)
Analytical Information
Create a new block for each
result e.g. ir, uv etc.
Analytical Information
1.5 Joint Submission
Information on JS is obtained solely from REACH-IT, any information (name of JS) provided here will not be taken into account but can be used for your administrative purposes
If you are not submitting jointly, do not complete any information in this section
Joint Submission
JS name communicated in SIEF by LR
1.7 Suppliers (ORs ONLY)
Only representatives (ORs) are advised to complete this section with information on the importers whose tonnages represented
Letter of appointment from the non-EU manufacturer
Suppliers
Create the Substance Dataset
Introduction
General Information
Manufacture, use and Exposure3.1 Technological process
3.2 Estimated quantities
3.3 Sites
3.4 Form in the supply chain
3.5 Identified uses
3.6 Uses advised against
3.7 Waste from production and use
3.1 Technological Process
Description(s) of the technological process used in the manufacture of the substance or production of articles, as appropriate
Repeatable blocks, in case used in more than one process
ORs / importers must provide justification e.g. “as an importer I am not involved in the manufacture of substances or the production of articles”
Technological process
3.2 Estimated Quantities
Tonnage per year that is subject to REACH registration
Indication of M/I own use(s)
Tonnage calculated per calendar year, since REACH came into effect
Estimated quantities
3.3 Sites (Manufacturers ONLY)
Only complete if ticked checkbox for manufacturer in section 1.1
Manufacturing
Use
ORs / importers must skip this section (no justification required)
Sites
It will link to the LE site created
earlier
Sites
Sites
Sites
3.4 Form in the Supply Chain
Must indicate if registering: A substance
A substance in a mixture
A substance in an article
Physical state in which it is made available to downstream user
Form in the supply chain
Repeatable blocks for the % of
Substance in each mixture manu
or imported and each article
produced
Sites
3.5 Identified Uses
General description on the identified use(s)
One use per line created
At least one use must be provided
If several lines are created in the table, then all lines must be completed
If multiple uses, multiple lines must be created
Use Descriptors
Abbreviation Full Name Description
SU Sector of use category Main user groups for all usesof the substance known / communicated to you.
PC Chemical product category Chemical product type in which the substance is supplied to end user.
PROC Process category Application / process types relevant to occupational exposure
ERC Environmental release category
Conditions of use defined from environmental exposure
AC Article category Article types in subsequentservice and waste life.
Identified uses
Provide at least one use per line in any of the three use types
Identified uses
Identified uses
Identified uses
Identified uses
Identified uses
Where no use is recorded, a justification
with a reason must be provided
Identified uses
3.6 Uses advised against
Information on use(s) registrant advises against as specified in Annex VI section 3.7 of REACH and why
Uses advised against
3.7 Waste from Production and Use
Information on waste quantities and composition of the waste resulting from the production and identified use(s) as specified in section 3.6 of Annex VI of REACH
Non-manufacturers or no waste must provide a justification
Waste from production and use
Create the Substance Dataset
Introduction
General Information
Manufacture, use and Exposure
Chemical Safety Report
Dataset Checks (TCC tool)
Create the Dossier
Export the Dossier
Chemical safety report
Chemical Safety Report (CSR)
Whether you are providing your own CSR & Guidance on safe use (Opt-out) or not, you must create an endpoint in this section.
Opt-out: must meet the criteria of Article 11(3) and 19(2)
Otherwise you must communicate with the LR to ensure your uses are covered by their CSR
Chemical safety report
Chemical safety report
Chemical safety report
COFFEE BREAK
Part I…contd
Create the Substance Dataset
Introduction
General Information
Manufacture, use and Exposure
Chemical Safety Report
Dataset Checks (TCC tool)
Create the Dossier
Export the Dossier
TCC check on the substance dataset
TCC check on the substance dataset
TCC check on the substance dataset
Click on this in the grey
Areas only, and it will
bring you to the error
TCC check on the substance dataset
No constituent entered:
select edit and add the
constituent(s)
TCC check on the substance dataset
TCC check on the substance dataset
Create the Substance Dataset
Introduction
General Information
Manufacture, use and Exposure
Chemical Safety Report
Dataset Checks (TCC tool)
Create the Dossier
Export the Dossier
Create the Dossier
READ ONLY
Any changes must be made to the substance dataset and the dossier re-created
Run the TCC tool on the dossier again
When no more failures show up, your dossier is ready for export
Create the dossier
Create the dossier
Create the dossier
Select both EU REACH and No
Regulatory Purpose
Create the dossier
Create the dossier
Create the dossier
Create the dossier
Negative selection
Create the dossier
Create the dossier
Re-run the TCC tool
Re-run the TCC tool
Re-run the TCC tool
Create the Substance Dataset
Introduction
General Information
Manufacture, use and Exposure
Chemical Safety Report
Dataset Checks (TCC tool)
Create the Dossier
Export the Dossier
Exporting
Select the dossier for export
In the file menu, select export
Choose a file name and location on your drive
Select finish
This file can now be uploaded to REACH-IT
Export the dossier
It will look like this
on your desktop
Part II
Submission Activities
Submission Activities
Joining the joint submission
Submitting the Dossier
Business Rules Verification
Technical Completeness Check
Fees and invoicing
Post submission
Submission Activities
Joining the joint submission
Submitting the Dossier
Business Rules Verification
Technical Completeness Check
Fees and invoicing
Post submission
Chronology of Submission
Lead Registrant creates the Joint submission (& communicates tokens)
submits the Lead Dossier
passes BRV and dossier is accepted for processing
then
Member Registrantreceives a message in RIT
commence submissions
submission complete only when Lead dossier is complete
The Security Token
Automatically generated string of alpha- numeric characters
Made available to the LR on his creation of the Joint Submission Object (JSO)
Ensure a definite association between the Lead and member dossiers
Communicated to member registrant outside of REACH IT
Each token has a validity of 30 days
Member has 5 attempts to enter token
REACH IT
Log on to REACH IT from the ECHA Website
Confirm Membership of the Joint Submission
Joint Submission
Confirm Membership
Use of the Security Token
JS Formaldehyde
835-d34-c518-297849814
Confirm Membership of the Joint Submission
Confirming membership of a JS: Step 2
Confirm Membership of the Joint Submission
Insert contact of person responsible for the submission if different from original contact
Confirm Membership of the Joint Submission
Formaldehyde
Confirm Membership
Joint Submission Status
View Status of the Joint Submission
Submission Activities
Joining the Joint submission
Submitting the Dossier
Business Rules Verification
Technical Completeness Check
Fees and invoicing
Post submission
Registration/Notification
Submit Registration/Notification
Submit the Member Dossier in REACH IT Submit a New Registration
Submit the Member Dossier in REACH IT
Registration
Submit the Member Dossier in REACH IT Provide Registration Info
Verify Company size by ticking the declaration
Related to a Joint submission must be
selected
JS Formaldehyde
Submit the Member Dossier in REACH IT Upload IUCLID 5 file
Submit the Member Dossier in REACH IT Confirm Submission
Confirm Submission
Submit the Member Dossier in REACH IT Issuing preliminary submission Number
Message relating to the Submission will appear in the RIT message Box
Submission Activities
Joining the Joint submission
Submitting the Dossier
Business Rules Verification
Technical Completeness Check
Fees and invoicing
Post submission
Business Rules Verification
Screen Shot
Business rule verification
Business rules Verification
Set of prerequisites that must be fulfilled before REACH IT can establish that the dossier can be handled
Checked in REACH IT
For example: Incorrect IUCLID format ( Must be 5.2), no valid identifier eg pre-registration, inquiry number etc
Once passed, Dossier progresses to processing
Business Rules Verification
Majority automatic (Enforce rules) and results found in submission report
Other (Mandatory rules) checked by ECHA and failures communicated via PDF file under ‘Annotations section’
Examples: Top Ten
Run the TCC tool also for BR checking
Submission Activities
Joining the Joint submission
Submitting the Dossier
Business Rules Verification
Technical Completeness Check
Fees and invoicing
Post submission
Technical Completeness (ECHA)
Activity performed by ECHA on all dossiers
Same as TCC Tool Check
Check on all required elements of the dossier type and receipt of fees
Consequence: 2 failures = repayment of fee
Completeness Check (ECHA)
Within 3 weeks or 3 months (from 30th Sept 2010)
If dossier is incomplete or invoice not paid ECHA will communicate extended deadline
Failure to meet this deadline: a second deadline is set
Failure to meet second deadline, failure to pay and failure to submit missing information = 2nd Failure of TCC and second fee chargeable
Submission Activities
Joining the Joint submission
Submitting the Dossier
Business Rules Verification
Technical Completeness Check
Fees and invoicing
Post submission
Invoicing
An invoice is issued for a registrationIf the dossier is accepted for processing and
If a fee is required according to the Fee Regulation
Invoice is sent via the REACH IT internal messaging system
Main factors affecting the Fee amount ;Tonnage band
Dossier type
Company size
Confidentiality Claims
Joint versus individual submission
Invoice location
Arrangements with accounting department
Pay the invoice in time (currently max 44 days from date of opening the invoice; for 2010 dossiers submitted after 1 Oct, will become max 60 days)
One invoice, one payment
Fees & Invoicing
A new Fee calculator tool to be released in October
IUCLID Plug-in available from the IUCLID website
Submission Activities
Joining the Joint submission
Submitting the Dossier
Business Rules Verification
Technical Completeness Check
Fees and invoicing
Post submission
Post Submission
Request for updates
Communications from ECHA
ECHA sends registration number to Lead once dossier is considered complete
ECHA will send registration number to member once member dossier is considered complete
ECHA REACH IT web-pages
Help
Helpdesk [email protected]
Countdown to Registration Webpage
Email communications
Packs
IUCLID Demo
Guidance documents
Part III
Q & A and IUCLID demo