RIP 4.4: Guidance document on preparation of Annex XV dossiers Erik van de Plassche and Hlne Magaud

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RIP 4.4 Guidance document on preparation of
Annex XV dossiers Erik van de Plassche and
Hélène Magaud European Chemicals Bureau, DG JRC
/ IHCPElina Karhu (DG ENTR)Peter van der Zandt
(DG ENV)TC CL Arona 3rd October 2006
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RIP 4.4

• Contractor BRE in consortium with RPA and IEH
• Project time 14 months
• Kick-off March 2005
• Stakeholder Expert Group (SEG) meetingsSEG 1
  May 2005SEG 2 September 2005SEG 3 December
  2005
• Additional SEG on Restrictions 23 January 2006
• SEG 4 March 2006
• Interim consultations Combined RRSM/LWG, TC CL
  and PBT WG
• Final report 30 May 2006

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Annex XV

• If action should be taken under
• Restrictions unacceptable risk to human health
  or environment and community wide action needed
• Authorisation identification of SVHC
• Harmonised classification and labelling
• ?
• Proposal for action has to be put forward
  according to Annex XV requirements

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Process Annex XV dossier

• Registration CSR from one or more registrants
• ?
• Substance Evaluation request for more
  information
• ?
• Annex XV dossier
• ?
• (Priority setting for Annex XIV inclusion)
• ?
• Annex I of 67/548 / Annex VI GHS
• Annex XIV inclusion and authorisations
• Annex XVII

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(No Transcript)
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Guidance Document Annex XV

• Introduction
• Annex XV
• Links to other guidance and processes under REACH
• Dossier for harmonised CL
• Dossier for identification of substances of very
  high concern (SVHC)
• Dossier for restrictions proposal
• Appendices

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Guidance Document Annex XVHarmonised CL

• Content
• Introduction
• Legal basis
• Process
• Information collection
• Information review
• Producing the report
• Annexes format, examples, related EU legislation

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Harmonised CL

• Characteristics
• Process related guidance (RIP 3.6 Guidance on
  CL under GHS)
• Based on experience of current legislation no
  intensive discussions in SEG
• Content
• Justification for other endpoints than CMR and
  respiratory sensitization Annex on relevant EU
  legislation
• Information for priority setting removed to
  Annex XV Identification SVHC
• Annex XV dossier for one or more endpoints
• Examples
• Format

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Consultation

• Interim consultation TC CL comments received
  from UK, DE and FR were incorporated in final
  report
• Consultation RRSM/LWG June 8
• Consultation TC NES June 14
• Consultation TC CL October 3
• Written comments asap
• Send by e-mail to reach.support_at_jrc.it

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Final guidance

• Commission will incorporate comments from
  consultations and produce final document for
  discussion at CWG (22-23 November)
• Basis will be the legal text agreed by the
  Council in June 2006
• Document has to be brought in line with other
  RIPs afterwards, if needed

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RIP 3.10 Substance Identification

• Substances as defined in RIP 3.10
• Mono constituent substances
• Multi constituent substances
• UVCBs
• To be incorporated in format Chapter 1

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Final guidance

• Guidance on developing Annex XV dossiers will be
  integrated into the overall guidance package
  final report will be split-up in three Guidance
  Documents
• Each Guidance Document will contain introduction
• Requirements Regulation
• Main tasks of actors involved including reference
  to other guidance
• Workflows and time lines
• Overview of relevant formats

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Guidance Documents
Harmonised CL
Registration

• Introduction
• Requirements in the regulation
• Man tasks of the actors
• The workflows
• The time limits

Authorisation MS
Authorisation IND
Restriction
DU requirements
Evaluation
Articles
CSA
SEA
Substance ID
CL