Guidance on Information Requirements and Chemical Safety Assessment RIP 3'2 and 3'3 Frans M' Christe

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Guidance on Information Requirements and
Chemical Safety Assessment(RIP 3.2 and
3.3)Frans M. Christensen and colleaguesEuropea
n Commission, DG JRCInstitute for Health and
Consumer Protection (IHCP) European Chemicals
Bureau (ECB)3rd REACH CA meeting, agenda item
5.2 (4.2)27-28 March 2008, Brussels
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Overview Process

• Draft guidance made available to REACH CAs end of
  NOV 2007
• Detailed presentation by RIP 3.2-2 contractor
  (Thomas Jostmann, CEFIC) at REACH CA meeting
  19-20 DEC 2007
• COM assessed that the guidance was not yet ready
  for endorsement and CAs asked for more time for
  reading/commenting.
• -gt Dead-line for written comments extended to 18
  January 2008 realising that next circulation to
  CAs would only be a couple of weeks prior to
  March CA meeting
• Guidance updated and written CA comments
  addressed under the RIP 3.2-2 contractor lead
  (CEFIC) with significant contributions from ECHA,
  RIVM, TNO and ECB
• Updated guidance and responses to comments
  uploaded on CIRCA 7-11 March 2008

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Updated guidance

• Detailed presentation of the draft guidance
  during the Dec 2007 CA meeting
• The cover note gives a rather detailed overview
  of changes since the latest version
• Responses to comments outline how CA comments
  received by 18 January have been addressed
• -gt No detailed presentation of the guidance at
  this meeting

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Updated guidance

• Main changes
• Pathfinder/road-map Section A1 and as a guide
  in the cTGD
• Streamlining of content and terminology and
  deletion of redundant text
• Improved cross-referencing (although still not
  perfect)
• Content-related clarifications and amendments
  largely based on the written CA comments

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CAs invited to endorse

• .. the current version of the guidance
  considering
• The extensive stakeholder process over the past
  three years
• The first registration dead-line is quickly
  approaching need for making guidance available
  on ECHA web-site
• The foreseen further process and updates (as
  outlined in cover note and summaries in the
  following slides)

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Next steps - 1

• Issues not needing further CA endorsement
• Guidance updated under time pressure -gt Still
  need for editorial work, in particular
• Cross-referencing, terminology harmonisation
• Merging of glossaries (appendix to Ch. R. 7 and
  Chapter R. 20) and how this links to glossary on
  ECHA web-site
• Further limited clarifications agreed during this
  meeting

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Nest steps - 2

• Additional elements of the guidance to be further
  elaborated and presented for endorsement at June
  CA or via written procedure
• Consumer exposure assessment, incl. role of the
  ECETOC TRA and Cons-expo. Expert group (based on
  RIP 3.2-2 SEG established). Meeting 11 April
  2008, Helsinki.
• Exposure Scenarios for preparations/generic
  exposure scenarios. Arona network /extended RIP
  3.2-2 SEG meeting planned. 1.5 days during 19-21
  May (exact dates and venue to be confirmed).
• Further development of Part F (preparing the CSR,
  incl. format) in close cooperation with the
  CSA-CSR-IT tool project. Meeting planned for 24
  April, Helsinki. Sub-group of RIP 3.2-2 SEG.
• Finalisation of chapter R.18 (how to address the
  waste phase in a CSR as a resulting life cycle
  stage).
• Specific annex on risk/safety assessment of
  metals and metal compounds. Special workshop
  planned as part of the TC NES meeting in April

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Next steps - 3

• Additional elements of the guidance to be further
  elaborated during 2008-2009 and presented for
  endorsement as appropriate
• Guidance on how to address Annex VI(6)
  information related to use and exposure for 1-10
  tonne/a substances.
• CSA-CSR generator IT tools. Further addressed
  under separate agenda item
• Continued work on the Exposure Scenario concept
• Guidance on use of human data for setting DNELs
  and DMELs. On-going. Drafting group established
  based on CA nominations for NOV 2007 workshop on
  the same issue
• Other supportive information, e.g. libraries of
  generic exposure scenarios

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Next steps - 4

• Practical examples and tools (to be) developed
  and made available by industry
• Examples based on RIP 3.2-2 and RIP 3.3-2
  activities, including exposure scenario examples.
  CEFIC in cooperation with DU organisations. NB!
  Industry is invited to cooperate closely with the
  CSA-CSR tool project
• Risk Management Measures (RMM) library. Made
  available on CEFIC web-site as developed in RIP
  3.2-2 project. CEFIC intends to maintain and
  develop it further.
• Standard phrases for extended Safety Data Sheets
  (eSDS). Lead by Business Europe.

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Next Steps - 5

• ECHA will make endorsed guidance available
• before 1 June 2008 based on step 1
• shortly thereafter additional elements based on
  step 2
• Further updates based on step 3 and other
  comments/experience collected will follow the
  ECHA endorsement procedures
• Specific comments to any published guidance can
  be submitted via the ECHA guidance web-site

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Thank you for your attention !