Transcript Slide 1

Countdown to REACH
Registration
Majella Cosgrave and Roseleen Murphy
Health & Safety Authority
21st April 2010
Overview
Overview of registration
Actors in the supply chain and roles
SIEF participation and data sharing
Getting started in IUCLID5 and REACH IT
Roles and tasks of lead and member
registrants
Dossier generation and submission
Guidance and user manuals available
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REACH Scope
Applies to actors in the supply chain:
Manufacturers
Importers
Distributors
Downstream Users
Chemicals
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)
4
Scope of registration
Generally, substance on its own or in a
preparation, or incorporated into an
article, manufactured in, or imported into,
the EU, at quantities greater than 1 tonne
per annum, must be registered
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Actors in the supply chain
Manufacturer – manufactures a substance
Importer – imports a substance into EU from
outside the EU
√ Both have registration duties (if substance M/I
above 1 tonne per annum)
Downstream user: sources substance in EU
Distributor: stores and place substance on
market (sources in EU)
× Neither have registration duties
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Pre-registration to
Registration
Pre-Registration
Ran from 1st June - 1st Dec 2008
Applied to M/I substances > 1 tonne/yr
System to allow for ‘staggered’
registration of ‘existing substances’
Facilitated the formation of Information
Exchange Forums (SIEFs) and data
sharing
Completed via REACH IT
2.75m received (143,000 substances)
Registration Timelines
30th November 2010
Phase-in substances M/I at > 1000t/yr
& CMR> 1t/yr & R50/53 > 100 t/yr
31st May 2013
Phase-in substance M/I at > 100t/yr
31st May 2018
Phase-in substances M/I > 1t/yr
Information Exchange: SIEFs
Substance Information Exchange Forum
Formed for each pre-registered substance
with the same identity
Consists of potential registrants, data holders
Forum to help registrants who intend to
register the same substance
Facilitates data sharing and allows for
agreement on classification and labelling
Different roles within a SIEF…….
All SIEF participants
React to requests for information from
other participants
Provide other participants with existing
studies, upon request
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Potential registrants
Request missing information from other
SIEF members
Identify needs for further studies
Arrange to perform identified studies
Agree on classification and labelling
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Data holders
Any person holding data on the substance
and willing to share it
Must respond to a query from potential
registrant if they hold data
Not entitled to request data
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SIEF Formation Facilitator
Pre-registrant could volunteer at pre-SIEF
to be the SIEF formation Facilitator (SFF)
Role was/is to initiate discussions
Facilitates exchange of information to
allow SIEF to be formed
No formal recognition in REACH
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Lead Registrant
All SIEFs must elect a lead registrant
Can be only one LR for a substance
Not automatically given to SFF
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
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Consortia
Type of co-operation between groups of
registrants to help with data sharing
No requirement under REACH
May have more than one consortium in
the same SIEF
Consortia members still have data sharing
obligations with the other SIEF members
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Data Sharing and Joint Submission
One
Substance
One Joint
Submission
One SIEF
One Lead
Registrant
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SIEF participation and Data sharing
Article 29(3) of REACH outlines the
fundamental rule for SIEF functioning:
“SIEF participants shall provide other
participants with existing studies, react to
requests by other participants for
information, collectively identify needs for
further studies……and arrange for such
studies to be carried out”
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SIEF Participation and Data Sharing
Purpose of SIEFs is to share data and
avoid duplication of testing
A SIEF is formed when companies agree
substance is the same
Members assess and share data and
prepare common parts of JS together
Requests for data related to vertebrate
testing to be responded to within 1 month
Financial compensation to be agreed
amongst the members
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SIEF Participation and Data Sharing
Joint submission dossier must contain:
Classification and labelling
Robust study summaries
Testing proposal (if required)
If information has been reviewed by assessor
Joint submission dossier may contain:
Guidance on safe use
Chemical safety report
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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
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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
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Information requirements
Annexes of REACH describe the requirements
Annex VI:
Registrant identity
Substance identity
C&L
Information about uses
Guidance on safe use
………
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Information requirements
Annexes VII to X
Physiochemical, toxicological, ecotoxicological
studies
Depend on tonnage:
1-10T: Annex VII
10-100T: Annex VII + VIII
100-1000T: Annex VII + VIII + IX
>1000T: Annex VII + VIII + IX + X
Chemical safety report: only for >10T
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Fulfilling information requirements
4 step process:
Gather existing information
Consider the information needs
Identify the information gaps
Generate new information or propose a testing
strategy in line with REACH obligations
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Fulfilling information requirements
Gather all available information, both inhouse and publicly available:
Intrinsic properties of the substance
Manufacture and use
Exposure
Risk management measures
Agree on a form of cooperation within the
SIEF regarding cost sharing
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Fulfilling information requirements
Evaluate the available data and determine
key study for each endpoint
Prepare robust study summaries (reflect
objectives, methods, results and conclusions of full study)
Determine precisely the information
requirements, depending on tonnage
Compare information requirements and
available information; data holders may
hold missing information
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Generation of new information/
testing proposal
If information gap, registrants must:
Generate information for Annexes VII and VIII
Prepare a testing proposal for Annexes IX and X
Registrant cannot proceed alone in generation
of new data; one must perform study on
behalf of others
All who require study must contribute to cost
Within 3 weeks of payment, right to receive
copy of full study report
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Right to study reports
Ownership of full study report
Parties who commissioned and paid for study
Legitimate possession of full study report
Term not defined; have a copy with right to use it
Right to refer to data
Mainly where owner provides ‘letter of access’
Copy of report, with no letter of access or right to
use the data not sufficient (unless publicly available
and not protected under copyright)
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Key Messages
Registration applies to substances M/I at
greater than 1 tonne per annum
One substance - one SIEF - one lead
registrant - one joint submission
Purpose of SIEF is to share data, avoid animal
testing, prepare joint dossier
Joint (lead) dossier and member dossiers
Information requirements tonnage dependent
Generation of data must be agreed within the
SIEF
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Dossier Submission Overview
IT Tools
Registration Dossier
Creating your IUCLID 5 Dossier
Creating a Joint Submission (LR)
Joining the Joint Submission (MR)
Submitting the dossier to ECHA
Post submission
Fees and invoicing
Known issues
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IT - Tools
REACH IT
Online system used by industry for the
secure submission of data and dossiers
on chemicals to ECHA
IUCLID 5
IUCLID 5 is an IT application built to
enter, store and report information on
hazardous properties of chemicals
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Create a REACH-IT account
From REACH-IT main page click the
“Sign up as a company” link.
provide information on:
• user contact details
• User ID / password
• upload LEOX
• company size …
• billing information
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REACH IT from Pre-registration
Account Creation per Legal Entity
UUID number, user name and
password generated
Contains pre-registrations and preSIEF details
Use this account for Registration
Allows for the formation of SIEFs
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IUCLID 5
IUCLID 5 is the tool for industry to fulfill
their REACH requirements
The only tool for preparing the
dossier: IUCLID 5
Available free of charge on ECHA
website
Where to get IUCLID 5
Freely available on the IUCLID 5
website
http://iuclid.echa.eu
Current Version of IUCLID is 5.2.
Only compatible with REACH IT 2.0
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Sign -Up
A unique combination of username and password is
requested to be used to access the website
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Legal Entity Object LEO
A unique identifier for your legal entity
All registrants required to have LEO
assigned to their company in order to:
Install the IUCLID 5 application
Submit a registration dossier via REACH
IT
A Leo was created for pre-registration
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LEO Synchronisation
IUCLID 5 and REACH-IT have to have the
same LEO (i.e. they need to be
synchronized)
One unique Legal Entity Object (LEO)
REACH-IT
IUCLID 5
LEO Synchronisation
If you have signed-up in REACH-IT for Preregistration purposes but have not yet
synchronised IUCLID 5 with REACH-IT you
must:
1.
2.
3.
Login on the REACH-IT webpage
Download from REACH-IT the company information
(LEO)
Upload the LEO in your IUCLID 5 application (during
installation)
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IT Tools in summary
REACH IT for data submission
www.echa.europa.eu/reachit_en.asp
IUCLID 5 for data gathering and dossier creation
www.iuclid5/eu
One Legal Entity = One LEO file
Must synchronise LEO between REACH IT and
IUCLID 5
Must use IUCLID version 5.2 for dossier
submission
Ref:
ECHA Industry User Manual 1: ‘Getting
started with REACH IT’
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The Registration Dossier
A set of information submitted
electronically by a registrant for a
particular substance with 2 main
components:
A technical dossier always
required(intrinsic properties of the substance)
A chemical safety report (CSR) where
required
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IUCLID 5 Dossier creation
To prepare a REACH registration dossier
you should:
1. Complete a substance dataset
Substance
(data set)
2. Create from that substance dataset a
Dossier
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Roles of Lead & Member Registrants
Different roles in relation to Dossier
Creation
EACH SIEF must appoint a Lead
Registrant (LR) to submit the Joint
dossier on behalf of all registrants
Other SIEF members known as
Member Registrants(MR)
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Lead Registrant Dossier Creation
LR gathers and prepares the technical data
Selects the highest tonnage band within the Joint
Submission template
Creates the Joint Dossier in IUCLID 5
Allows members to join the joint submission
Submits the Joint Dossier before 30th November
recommended in September (includes his own
Registration)
Receives his Registration Number
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LR Dossier Creation
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Lead or Joint Dossier
Joint submission dossier must contain:
Classification and labelling
Robust study summaries
Testing proposal (if required)
If information has been reviewed by assessor
Technical Dossier
Joint submission dossier may contain:
Guidance on safe use
Chemical safety report
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Member Registrant Dossier Creation
REACH Dossier templates
available in IUCLID 5
dossier creation wizard
http://echa.europa.e
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u
MR Dossier Requirements
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
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Section 1 General Information
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Importance of substance identity
Accurate Substance identity is essential;
to ensure that ECHA can be confident in the chemical
identity of each substance
to establish whether two substances (or more) are the
same
to ensure data sharing and joint submission operates
effectively and correctly
to ensure that the substance identity is clearly defined
for hazard and risk communication
one substance= one SIEF=one dossier=one registration
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Substance Identity
Substance Identity
IUPAC name, EINECS or ELINCS name and
number, usual trade names, CAS name and
number
Composition: Purity, impurities and additives
together with relevant identifiers and
concentrations
Analytical Data:
Spectral and Chromatographic data
Description of analytical methods used
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Summary of Information Requirements
JS LEAD registrant
Dossier
JS MEMBER
Dossier
Joint Submission Creation (Lead Registrant)
Creates Joint Object in REACH IT
Invites Member Registrants to join the Joint
Submission
Communicate the Joint Submission name to
members
Assigns ‘Tokens’ to member registrants
This communication must be completed outside
of REACH IT in secure manner
Submits Dossier before 30th November
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The Security Token
Generated by REACH IT
Categorised block of text
Issued by the LR outside of REACH
IT
Currently has a validity of 30 Days
If not utilised LR can re-issue
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Joining the Joint Submission
Once the LR has created the joint
submission in REACH IT
The MR must confirm
membership using the joint submission
name and the security token
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Viewing the Joint Submissions
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Submitting the Dossier
LR may submit the lead dossier
Only once the joint submission has been
created
A MR may submit the Member dossier
Only once the joint submission has been
created,
Membership has been confirmed
The LR has submitted the lead dossier
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Recommendations to Lead Registrants
Directors Contact Group, Industry/ ECHA liaison
recommends that the LR
Communicates the date they intend to submit the Lead
Dossier
Give the MR a ‘cut-off’ date after which they ‘freeze’ the
dossier will not allow:
Accepting previously identified dormant members
Substance sameness discussions
Operational rules discussions
Sharing existing data
Agreeing C&L
Finalising the CSR
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Joint Submission Summary
LR creates the Joint Object in REACH IT
Communicates the JS name and security tokens
to MRs
LR may communicate submission date and ‘Cut
off’ date to MRs
LR submits the Lead Dossier (at least 2 months in
advance of deadline)
MR confirms membership of JS
MR submits member dossier before 30th
November
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Post Submission and known issues
Business rules validation
Technical Completeness Check
Fees and Invoicing
Deactivation of SIEF interest
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Business Rules Validation
Business Rules Validation automatic
system check at ECHA
Format e.g. wrong IUCLID 5 template
used
Administrative e.g wrong registration
update does not provide a valid
reference number
Technical REACH IT cannot ‘understand’
the substance identifiers
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Technical Completeness Check
A mandatory Check carried out by ECHA to ascertain that
all the necessary elements required for a registration
including the fee have been provided
Carried out within 3 weeks or 3 months if submitted during
the last 2 months from September 2010
Where the information is incomplete ECHA sends a request
for missing information and sets a deadline for submission
of the complete dossier
After second TCC failure a new fee will need to be paid
TCC tool as IUCLID 5 plug-in check TCC of own dossier
before submission
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Fees and Invoicing
Fees automatically set based on your
company details
Invoice will be sent to REACH IT once the
dossier has been accepted for processing
NOTE Only to REACH IT inbox
Invoice sets a deadline
One chance to extend deadline
If not paid dossier is rejected
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Invalid & unnecessary Pre-registrations
Pre-registrant not Manufacturing a
substance
Pre-registrant not importing from outside
the EU
Pre-registered a preparation rather than a
substance
Pre-registered the wrong substance
Company activity winding up
Non EU supplier has appointed an Only
Representative
Invalid & unnecessary Pre-registrations
Substance does not require a registration
Non Isolated Intermediates e.g. Ozone
Annex V substances e.g. by-products
Articles e.g. iron bars
Substance used in food/feeding stuffs
Waste or recovered substances
Substances in articles , without intended
release
Substance is not M/I >1t/yr
Deactivation within the Pre-SIEF
‘Deactivate their interest’ in the preregistration
Alerts the SFF or the LR to the fact
Does not delete the pre-registration and
can be reversed
Does not negate the duties of the preregistrant for the life of the SIEF
Can demonstrate their status in REACH IT
Summary Post Submission
Automatic Business Rules Validation
TCC Check: Registrants should use
Tool
Fees and Invoicing automatically set
May be processing delays
No registration number until fees
have been paid
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Key Points
Communicate widely within your SIEF
Let your LR know that you intend to register this year
Ensure you have a valid UUID and LEO for use of IT
systems
LR must ensure the data set for the substance is complete
MR must ensure that member dossier is complete
Sign up to the joint submission using name and token
Use the TCC tool before dossier submission
Pay the appropriate fee
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Guidance and Help
ECHA Technical Guidance Documents
ECHA REACH IT Data submission manuals
New! Guidance Fact Sheets
IUCLID 5 help iuclid/eu
HSA REACHright.ie
[email protected] or 1890289389
IBEC reachaid.ie and [email protected]
LR Webinars at
http://echa.europa.eu/news/webinars_en.asp
REACHright E-Bulletin
Targeted communications from the helpdesk
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