Risk assessment and risk management

Risk assessment (Art. 15 of the Cartagena Protocol )

The objective 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).

It 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.

Risk management (art. 16 of the Cartagena Protocol)

Based on the scientific and technical information emerging during the risk assessment, which induces the decision maker to accept or not the assessed risk, with eventual limitations and requirements, the risk management is carried out on the basis of the application of appropriate mechanisms, measures and strategies to regulate, manage and control risks identified and associated with the use, handling and transboundary movement of LMOs.

An important aspect in the process of management of the risk deriving from LMOs is the so-called post-release monitoring, i.e. the activity of observation during the period following the emission in the environment of the LOM.

Monitoring allows to:

  • verify the effectiveness of containment measures taken by the person making the release and their compliance with applicable law;
  • check that no adverse effects, arising from factors not included in the risk assessment phase, emerge from LMOs on human and animal health and on the environment.

The European Food Safety Authority (EFSA) is an independent European agency, funded and operating independently by the European Commission, the European Parliament and EU Member States. It was established in January 2002 by Regulation (EC) n. 178/2002  as European reference body for risk assessment regarding food and feed safety.
It develops scientific advice providing a sound basis for the process of adopting European legislation on food and feed safety enabling the European Commission, the European Parliament and EU Member States to make urgent and effective decisions in risk assessment and risk management.

Tools for risk assessment and risk management

The risk assessment in Italy