Decision Opinion Support Document

1
Decision / Opinion Support Document

• 3rd REACH CA Meeting
• Jack de Bruijn
• Directorate B Operations

2
Opinions / Decisions

• Evaluation, be it evaluation of testing
  proposals, compliance checking or substance
  evaluation
• Harmonised Classification and Labelling
• Restrictions and
• Identification of Substances of Very High Concern
• And later on authorisation

3
Generic Information Flow

• ECHA Output
• Opinions
• Decisions

External Input (mostly static)
Internal and Committee Discussions
Registrants comments
Third party comments or information
MS and Agency comments
4

• Full scientific and technical reasoning behind
  ECHA opinions and decisions needs to be available
  !

5
Why?

• To provide full transparency on the scientific
  and technical reasons for the decisions/opinions
• To ensure consistency between substances
• To ensure consistency over time
• To document the ST reasoning in a way that will
  allow the Commission to take decisions within the
  (short) timelines set in REACH
• To record in one place the information needed by
  industry arising from the decisions (e.g.
  updating their dossiers)

6
Practical considerations

• Not a new document! The original document is used
  as a starting point.
• Add amendments, where necessary, showing
• New scientific information brought forward
• Differences in scientific argumentation leading
  to conclusions
• If needed, minority views or diverging opinions
  in or between Committees

7
Who does the work?

• 3 Options
• ECHA secretariat
• Committee (Member)
• The entity who prepared the original proposal
  (i.e ECHA secretariat or MS CA)
• Considerations
• Whos most knowledgeable of underlying
  literature?
• Who has easy access to the relevant info?
• Conclusion
• Entity who developed the dossier is most suitable
  party to develop the DSD

8
Sharing the burden of preparing the DSD/OSD

• MS CAs
• Substance Evaluation Decisions
• Annex XV dossiers
• ECHA
• Dossier Evaluation Decisions
• Annex XV dossiers, if requested by COM

9
Next steps

• Discussion at Ctees
• Discussion at CA meeting
• Preparation of examples for different DSD/OSD
  cases to be presented at next ctee meetings
• Clarify the interplay between the DSD, the
  minutes of the Ctee meetings and the format and
  contents of the final decision/opinion
• Clarify procedural aspects in terms of
• Timing of the preparation and adoption of the
  document
• What happens in cases where there is no (or
  partial) support of the Committee for the initial
  proposal

10
Comments?