Migration of NCD to IUCLID 5 Assignment of registration numbers

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Migration of NCD to IUCLID 5Assignment of
registration numbers

• 3rd Meeting of the REACH - CA
• 27-28 March 2008
• Document CA-12-2008

Christel Musset, ECHA
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Background

• Legal aspects
• Notification under Dir. 67/548/EEC considered as
  registered under REACH
• ECHA to provide a registration number by 1
  December 2008
• Hand-over file
• ECB transfers the New Chemical database (NCD) to
  ECHA
• ECB migrates the 7500 notifications
  (corresponding to 4750 substances) from the SNIF
  format to IUCLID 5 format
• ECB distributes the migrated files to the MS CAs

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Background

• Discussion points at the last CA meeting
• Distribution of the migrated files to the
  notifiers
• via the MS CAs
• Distribution of the registration numbers to the
  notifiers
• via REACH-IT after a verification carried out by
  the MS CA of the identity of the requester
• Outcome
• Comments to be provided by the MS CAs until
  mid-January
• Revised proposal

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Background

• Comments from MS CAs received in January 2008
• Follow-up document prepared in February, with the
  following changes to the initial proposal
• SNIF migration tool distributed to industry
  companies can migrate their own SNIF files for
  further updating their dossiers under REACH if
  necessary or preparing a registration dossier
  (intermediates). No need to contact the CAs to
  get their files.
• Simplified verification procedure done by the MS
  CA via REACH-IT, in case the identity of the
  company requesting a registration number does not
  match the identity mentioned in the notification
  file.

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Background

• Further comments received in February 2008
  detailed in Annex of CA/12/2008
• Summary
• Simplified proposal was welcome
• Additional concern about potential mismatch
  between the requester in REACH-IT and the
  notifier in the NCD
• Question of sole representative / only
  representative

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Status

• Migration tool SNIF to IUCLID 5
• On schedule
• ECB will be in the position to migrate the files
  by 1 June 2008
• SNIF migration plug-in could be released to
  industry, as soon as all testing steps for public
  release are completed. No final date announced
  yet.
• Assignment of registration numbers
• Implementation of the functionality in REACH-IT
  is postponed
• Distribution of registration numbers from
  September 2008

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Workflow

• Migrated files
• ECB sends migrated files to ECHA and to the MS
  CAs, starting in June 2008.
• ECHA publishes the SNIF migration tool (expected
  date June 2008?) as a plug-in to IUCLID 5
• Companies can migrate their own SNIF files
• Companies will be able to contact their CAs to
  get their original files (depending on the MS)
• (ECHA will not distribute the files because of
  confidentiality and need to build a specific
  workflow in REACH-IT)

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Workflow

• Registration numbers
• Notifier identifies himself in REACH-IT (sign-up,
  as of 1 June).
• Notifier requests his registration number via
  REACH-IT (dedicated menu as of September 2008)
• If match between requester and notifier, the
  registration number is sent (MS CA is simply
  informed)
• If no match, the MS CA is requested (via
  REACH-IT) to start the verification.
• If OK, then the registration number is sent (as
  in step 3)
• If non OK, the requester receives a letter from
  ECHA of the negative result. The requester is
  invited to contact his CA for clarification and
  starts from step 2 again when the problem is
  solved

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Other issues

• Sole representative / only representative
• Proposed to add a legal text on the REACH-IT web
  site by which the requester confirms that he is
  entitled to receive the registration number.
• It is not planned to ask the requester to
  submit any contractual arrangement in REACH-IT.

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Thank you for your attention