Risk Evaluations that satisfy Annex II

Annex II to the Rotterdam Convention sets out the criteria against which the Chemical Review Committee (CRC) will consider notifications of final regulatory actions on particular chemicals. 

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A key criterion of Annex II is found in part (b) which states that the CRC shall establish that the final regulatory action has been taken as a consequence of a risk evaluation.  This evaluation shall be based on a review of scientific data in the context of the conditions prevailing in the Party in question.  For this purpose, the documentation provided shall demonstrate that:

  1. Data have been generated according to scientifically recognized methods;
  2. Data reviews have been performed and documented according to generally recognized scientific principles and procedures;
  3. The final regulatory action was based on a risk evaluation involving prevailing conditions within the Party taking the action.”

It is mandatory that any risk evaluation used to take a final regulatory action on a chemical must satisfy these criteria before the chemical can be recommended for listing by the CRC.  Therefore, those risk evaluations that have already satisfied Annex II criteria are good examples when considering either undertaking a risk evaluation on a chemical or when bridging information from other evaluations.

Consequently, a compendium of these accepted risk evaluations is presented and can be accessed here.  DNAs are reminded, however, that any use of a risk evaluation undertaken by another Party is dependent on that other Party having similar local conditions.  Only then can a risk evaluation, through the process of bridging information be considered acceptable by the CRC.   DNAs may also contact other DNAs especially in their PIC region to share information that may be pertinent to making a decision for a final regulatory action on a given chemical.