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

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

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... Expert Group (SEG) meetings: SEG 1: May 2005. SEG 2: September 2005 ... Based on experience of current legislation: no intensive discussions in SEG. Content: ... – PowerPoint PPT presentation

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


1
RIP 4.4 Guidance document on preparation of
Annex XV dossiers Erik van de Plassche and
Hélène Magaud European Chemicals Bureau, DG JRC
/ IHCP Elina Karhu (DG ENTR) Peter van der Zandt
(DG ENV) TC CL Arona 3rd October 2006
2
RIP 4.4
  • Contractor BRE in consortium with RPA and IEH
  • Project time 14 months
  • Kick-off March 2005
  • Stakeholder Expert Group (SEG) meetings SEG 1
    May 2005 SEG 2 September 2005 SEG 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

3
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

4
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

5
(No Transcript)
6
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

7
Guidance Document Annex XV Harmonised CL
  • Content
  • Introduction
  • Legal basis
  • Process
  • Information collection
  • Information review
  • Producing the report
  • Annexes format, examples, related EU legislation

8
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

9
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

10
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

11
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

12
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

13
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
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