The aim of risk assessment is “to identify and evaluate the potential adverse effects of LMOs on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health" (from Annex III of the Cartagena Protocol) and it is used by the competent authorities to make informed decisions regarding living modified organisms (LMOs).

Risk assessment should be carried out in a scientifically sound and transparent manner, taking into account expert advices and guidelines developed by relevant international organizations.
Lack of knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk or the occurrence of an acceptable risk.
Risks associated with LMOs or derived products, namely LMOs processed materials containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology, should be considered in relation to risks posed by the unmodified recipient or parental organisms in the environment that potentially could receive them.
Risk assessment should be carried out on a case by case basis. The nature and the level of details required for the requested information may vary from case to case depending on the living organism concerned, on its intended use and on the potential receiving environment.

According to Annex III of the Cartagena Protocol risk assessment includes the following steps:

  1. an identification of any novel genotypic and phenotypic characteristics associated with the living modified organism that may have adverse effects on biological diversity in the likely potential receiving environment, taking into account  risks to human health;
  2. an assessment of the likelihood of these adverse effects being realized, given the degree and type of exposure in the environment that could receive the living modified organism;
  3. an assessment of the possible consequences in case that these adverse effects occur;
  4. an estimation of the overall risk posed by the living modified organism on the basis of the evaluation of the probability that identified adverse effects and the relative negative consequences will occur;
  5. a recommendation indicating whether or not risks are acceptable or manageable, including, where necessary, identification of strategies to manage these risks;
  6. if there is uncertainty regarding the level of risk, it could be useful to request additional information on specific issues of concern, and apply appropriate strategies for risk management and / or monitoring the living modified organism in the receiving environment.

Tools for risk assessment