References for making a risk evaluation

The term “Risk Evaluation” is used by the Rotterdam Convention in relation an evaluation of intrinsic toxicological and ecotoxicological properties and actual or expected relevant exposure, which may include information on actual incidents. One of the key criteria in Annex II of the Convention for listing chemicals under the Convention is to establish that the final regulatory action has been taken as a consequence of a risk evaluation. 

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The term “Risk Assessment”, according to (IPCS 2004), “is a process intended to calculate or estimate the risk to a given target organism, system, or (sub)population, including the identification of attendant uncertainties, following exposure to a particular agent, taking into account the inherent characteristics of the agent of concern as well as the characteristics of the specific target system. The risk assessment process includes four steps: hazard identification, hazard characterization (related term: Dose–response assessment), exposure assessment, and risk characterization. It is the first component in a risk analysis process.”

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To further support DNAs in their decision-making, scientific documentation is referenced and available here. The information is sourced from the Rotterdam Convention, reputable international organizations including WHO, FAO and other relevant IGOs, OECD, accredited institutions and national agencies. 

The documentation is presented by subject matter including:

  • Tools for making a risk evaluation
  • Hazard identification and classification
  • Exposure
  • Bridging information
  • Risk evaluations on Annex III chemicals
  • Annex I verified notifications
  • Annex II verified notifications for each region

As many developing countries do not have the requisite resources and skills to carry out in-depth scientific analyses linked to risk evaluation of toxic substances, such scientifically sound evaluations may not be forthcoming from developing countries. 

DNAs are reminded that the use of bridging information is available. The concept of ‘bridging information’ holds where the risk or hazard evaluations and exposure assessments completed in one country may be used by another country in support of its notification of final regulatory action submitted in accordance with Article 5 of the Rotterdam Convention, as long as both countries have similar local conditions.  More on bridging information is available here.

DNAs should seek to contact other DNAs both from developing countries and developed countries, especially in their region, to share information on making a risk evaluation. Contact information for DNAs is available here.