Use of IUCLID 4 by authorities

1
Use of IUCLID 4 by authorities
Seminar for Biocides Authorities, Sofia, 19 April
2006 Elisabeth Fassold Expert Centre Biocides
2
IUCLID Requirement

• REVIEW PROGRAMME, Reg. 2032/2003
• Annex IV, Requirements for the summary dossier
• (c) The formats made available by the Commission
  must be used for submission of the dossiers. In
  addition, the special software package (IUCLID)
  made available by the Commission must be used for
  those parts of the dossiers to which IUCLID
  applies. Formats and further guidance on data
  requirements and dossier preparation are
  available on the ECB homepage at
  http//ecb.jrc.it/biocides.
• NEW BIOCIDAL SUBSTANCES, BPD
• a IUCLID file is not part of the formal, legal
  requirements !

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Use of IUCLID, usefulness of IUCLID?

• TNsG on Dossier Preparation and Study Evaluation
  (TNsG DPSE)
• IUCLID applies to all studies performed on active
  biocidal substances
• IUCLID is supplement to Doc III
• IUCLID format version 4 is not detailed
• Reporting requirements in IUCLID key results and
  indication of study validity
• for key-studies or studies for which more
  detailed information is necessary Doc III-study
  summaries have to be provided in addition

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Use of IUCLID

• For the completeness check phase the TNsG DPSE
  proposes
• IUCLID study summaries to be used by the RMS as
  the basis for checking the selection of key
  study(ies)
• all key studies must also be entered into IUCLID
• TM Biocides proposes
• in order to avoid overlooking errors in IUCLID of
  influence on the selection of the key study(ies)
• IUCLID study summaries not the sole basis for
  checking the selection of key study(ies), but
• RMS also look into the original studies
  (Doc-level IV) to check their relevance and
  results
• For in-depth evaluation of the key study(ies) TM
  proposes
• in case of questions for a specific endpoint or a
  specific effect, refer to IUCLID and evaluate
  other original studies more closely

5
Responsibility for data submitted in IUCLID

• IUCLID is part of the summary dossier
• not part of the all-in-one-approach !
• no RMS version of the CA (for the CA report) !
• no active work of RMSs in the IUCLID dataset in
  the evaluation phase !
• accurateness of reporting and reliability of the
  data in IUCLID throughout the process remain with
  the participant !
• but RMS may ask the participant to update the
  information in IUCLID in case of contradiction to
  Doc-level IV test report
• for searchability after inclusion in, at least,
  local IUCLID software, it should be in electronic
  form as .exp file and in paper as pdf print-out

6
IUCLID-updates to final version

• IUCLID is not contained in the CAs reports
• but participant to provide a correct and
  comprehensive final IUCLID version
• after formal finalisation of dossier evaluation
  by the RMS and prior to Annex I/IA (non)inclusion
  has been decided on EU level
• TM proposal that final version of the IUCLID
  dataset is provided to the RMS within three
  months after the dispatch of the CA report to the
  Commission not effectively applied across RMS
  and
• RMS or the Commission to ask the participant for
  it ?