Allinone approach

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All-in-one approach
Seminar for Biocides Authorities, Sofia, 19 April
2006 Elisabeth Fassold Expert Centre Biocides
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Overview

• Application dossier requirements
• Biocidal substances
• Biocidal products
• Guidance
• Work with the all-in-one approach
• CA report information transfer

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Application dossier requirements I

• Legal provisions, biocidal substances
• BPD Article 11, Procedure for inclusion of an
  active substance in Annex I, IA or IB
• 2nd Review Regulation (EC) No 2032/2003, Annex
  IV, Requirements for the complete dossier and
  the summary dossier
• Legal provisions, biocidal products
• BPD Article 8, Requirements for authorisation

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Application dossier requirements IIbiocidal
substances

• Annex IV, Requirements for the summary dossier
• (b) The summary dossier must include the
  following
• in the case of a collective dossier, the name
  of all participants concerned and a person
  designated by them as being responsible for
  the collective dossier and the processing of the
  dossier in accordance with this Regulation
• for each point of Annex IIA and IIB, or Annex
  IVA and IVB, to Directive 98/8/EC, and where
  specified the relevant parts of Annex IIIA and
  IIIB to the Directive, the summaries and results
  of studies and trials
• list of references used
• risk assessment
• overall summary and assessment
• a check by the participant or, where
  appropriate, by the person designated as
  responsible for a collective dossier of the
  completeness of the dossier.

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Application dossier requirements III biocidal
substances

• 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.

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Application dossier requirements IV biocidal
substances

• Annex IV, Requirements for the summary dossier
• (d) For existing active substances that have been
  or are being evaluated under the review
  programme for plant protection products in
  accordance with Article 8(2) of Directive
  91/414/EEC , the required format for an
  application for inclusion in Annex I thereto may
  be used for the preparation of the dossier for
  inclusion of the existing active substance in
  Annex I, IA or IB to Directive 98/8/EC, taking
  into account relevant differences in the dossier
  requirements. A summary of the dossier must be
  entered in IUCLID. Additional information
  related to the biocidal use must be submitted in
  accordance with the requirements of this
  Regulation.

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Guidance

• European Chemicals Bureau http//ecb.jrc.it/bioci
  des/
• Technical Notes for Guidance (TNsG) on
  Preparation of Dossiers and Study Evaluation
• includes all details on the all-in-one approach

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Application dossier - substances

• Dossier Structure
• National application form and other legal
  requirements
• Active Substance Annex I/IA inclusion plus
  Representative Product
• Application form (EU)
• Completeness check forms
• Study summaries - Doc III
• Risk assessment - Doc II
• Summary - Doc I
• Test and study reports (Doc IV)
• IUCLID file (supplement to Doc III)

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Structure of the dossier
TNsG on Preparation of Dossiers, modified to
practical use
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Work with the all-in-one approachCompleteness
check
Application form - doc I
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Work with the all-in-one approachCompleteness
check
Serves for
? communication with applicant
? after completeness confirmed it is sent to
applicant ? summary dossier

• after evaluation, all in one into CA report

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Work with the all-in-one approachCompleteness
check, quality of data
Completeness check form
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Work with the all-in-one approachEvaluation
Study summary - doc III

• after evaluation, all-in-one into CA report

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Risk assessment - doc II
Doc. II Risk Assessment
Doc. II-C Risk Characterisationfor Use of A.S.
in B.P.(s)
Doc II-AEffects and ExposureAssessmentActive
Substance

• The risk assessment should be performed by the CA
  based on
• the risk assessment submitted by the applicant
• the critically evaluated study summaries
• other relevant information

LIMITED ALL IN ONE
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Doc. IEvaluationReport

• Statement of subject matter and purpose
• Overall summary and conclusions
• Proposal for the decision
• Background for decision
• Proposed decision on inclusion in I, IA
• Justification for the restriction(s)
• Demand for further information
• Appendix List of end points
• List of abbreviations
• Check for completeness

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CA Report information transfer I
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CA Report information transfer II
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Product authorisation/registration- dossier
structure