• Open Access

Guidance on human health risk-benefit assessment of foods


  • EFSA Scientific Committee

  • Scientific committee members: Susan Barlow, Andrew Chesson, John D. Collins, Albert Flynn, Corrado L. Galli, Anthony Hardy, Klaus-Dieter Jany, Michael-John Jeger, Ada Knaap, Harry Kuiper, John-Christian Larsen, David Lovell, Josef Schlatter, Vittorio Silano, Frans Smulders, Philippe Vannier.
  • Correspondence: scientific.committee@efsa.europa.eu
  • Acknowledgement: EFSA wishes to thank the members of the Working Group on Risk Benefit Assessment for the preparation of the draft opinion: Ada Knaap (Chair), Diane Benford, Alan Boobis, Helmut Heseker, Rolaf van Leeuwen, Hildegard Przyrembel, Ivonne Rietjens, Josef Schlatter and Ivar Vågsholm and EFSA's staff member Bernard Bottex for the support provided to this EFSA scientific output.
  • Adoption date: 29 June 2010
  • Published date: 12 July 2010
  • Question number: EFSA-Q-2007-0043
  • On request from: EFSA


The Scientific Committee of the European Food Safety Authority (EFSA) developed guidance for performing risk-benefit assessments of food. The document focuses on human health risks and human health benefits, and does not address social, economic and other considerations such as “cost-effectiveness” considerations. It is considered as essential that formulation of the problem precedes the risk-benefit assessment as such. Agreement between the risk-benefit assessor and the risk-benefit manager on the terms of reference should be reached in order to ensure that the outcome of the assessment is useful and relevant for the risk-benefit manager goals. A stepwise approach is recommended for the risk-benefit assessment, i.e. i) initial assessment, addressing the question whether the health risks clearly outweigh the health benefits or vice versa, ii) refined assessment, aiming at providing semi-quantitative or quantitative estimates of risks and benefits at relevant exposure by using common metrics, and iii) comparison of risks and benefits using a composite metric such as DALYs or QALYs to express the outcome of the risk-benefit assessment as a single net health impact value. The outcome of each step of the assessment should also include a narrative of the strengths and weaknesses of the evidence base and its associated uncertainties. After each step of the risk-benefit assessment, discussion should take place between the risk-benefit assessor and the risk-benefit manager on whether sufficient information has been provided or whether the terms of reference should be refined in order to proceed with the next step of the assessment. Two examples (selenium as an indispensable nutrient, and fish consumption) illustrate the proposed approach for risk-benefit assessment.