European Journal of Nutrition

, 48:33

Safety impact—the risk/benefits of functional foods

  • Gérard Pascal
Supplement

Abstract

It is amazing to see how much the approach of the food risk analysis evolved in the recent years. For half a century and the birth of the risk assessment methodology in the food domain, only no appreciable health risk was considered acceptable by the manager. This is the vocabulary used in the case of a voluntary, deliberated human action, as the use of food additives (definition of ADI). In the case of risks not resulting from such an action, as that of the presence of contaminants, the risk assessor allocates provisional tolerable daily, weekly or monthly intake that are the basis for regulation. This vocabulary is in agreement with the objective which consists in approaching closer possible of the zero risk which is the wish of a majority of the consumers. Some years ago, the risk managers insisted to obtain from the assessors as often as possible a quantitative risk evaluation. More recently even, the managers would like to decide on the basis of a balance of risk and benefit acceptable for management purposes. Finally, they hope that general principles and tools will be available for conducting a quantitative risk-benefit analysis for foods and food ingredients. What is possible in the case of functional foods (FF)? Based on the definition of FF proposed in the programme FUFOSE, one has to distinguish between different situations in order to assess the risk: that of a micro-, that of a macro-component or that of a whole food. These situations have been clearly described in the document resulting from FOSIE. The standardized methodology relevant to assess micro-components is not well adapted to the assessment of whole food. Concepts of substantial equivalence and of history of safe use could be useful tools in this case. However, quantitative risk assessment remains a very difficult exercise. If a process for the assessment of health benefit of FF has been proposed as an outcome of the PASSCLAIM action, the quantification of this benefit needs adequate tools. An EFSA scientific colloquium on “Risk-Benefit Analysis of Foods” organized in July 2006 concluded that the risk-benefit analysis should mirror the current risk analysis paradigm and that its assessment should be performed with common scales. Disability adjusted life years (DALYs) or quality adjusted life years (QUALYs) have been proposed as some of these common scales. However, the meeting “concluded that the data available to undertake a quantitative risk-benefit assessment may be too scarce”. Because it was considered that it was premature to formulate guidelines on good risk-benefit analysis practice and it is now time to “learning by doing”, a reference to the upcoming ILSI Europe project BRAFO was done. All these aspects are discussed, in particular in relation to the specific case of FF.

Keywords

Functional foods Safety Risk Benefits 

References

  1. 1.
    Agett PJ, Antoine J-M, Asp N-G et al (2005) PASSCLAIM—process for the assessment of scientific support for claims on foods. Eur J Nutr 44(Suppl 1):1–30Google Scholar
  2. 2.
    Barlow S, Dybing E, Edler L et al (2002) Food safety in Europe (FOSIE): risk assessment of chemicals in food and diet. Food Chem Toxicol 40(2/3):137–428Google Scholar
  3. 3.
    Committee on Carcinogenicity of chemicals in food, consumer products and the environment (COC) (2004) Guidance on a strategy for the risk assessment of chemical carcinogens. http://www.advisorybodies.doh.gov.uk/coc/guideline04.pdf
  4. 4.
    Constable A, Jonas D, Cockburn A et al (2007) “History of safe use” as applied to the safety assessment of novel foods and foods derived from genetically modified organisms. Food Chem Toxicol 45(12):2513–2525CrossRefGoogle Scholar
  5. 5.
    Diplock AT, Aggett PJ, Ashwell M et al (1999) Scientific concepts of functional foods in Europe: consensus document. Br J Nutr 81(Suppl 1):S1–S27Google Scholar
  6. 6.
    Dybing E, Doe J, Groten J et al (2002) Hazard characterisation of chemicals in food and diet: dose response, mechanisms and extrapolation issues. Food Chem Toxicol 40(2/3):237–282Google Scholar
  7. 7.
    EFSA (2005) Opinion of the Scientific Committee on a request from EFSA related to a harmonised approach for risk assessment of substances which are both genotoxic and carcinogenic, adopted on 18 October 2005. EFSA J 282:1–31Google Scholar
  8. 8.
    EFSA (2007) 6th Scientific Colloquium report: risk-benefit analysis of foods: methods and approaches (13–14 July 2006), July 2007Google Scholar
  9. 9.
    EU Scientific Committee for Food (SCF) (1997) Thirty-ninth series of report, the assessment of novel foods:Google Scholar
  10. 10.
    EU Scientific Steering Committee (SSC) (2000) Opinion on harmonisation of risk assessment procedures, Adopted on 26−27 October 2000. European Commission pp 173, annexes pp 261Google Scholar
  11. 11.
    Food Safety Council (1978) Proposed system for food safety assessment. Food Cosmet Toxicol 16(Suppl 2):1–136Google Scholar
  12. 12.
    Havelaar AH et al (2000) Balancing the risks and benefits of drinking water disinfection: disability adjusted life years on the scale. Environ Health Perspect 108(4):315–321CrossRefGoogle Scholar
  13. 13.
    JECFA (2000) Joint FAO/WHO Expert consultation of foods derived from biotechnology, Topic 1: the concept of substantial equivalence, its historical development and current use. Biotech 2000/03, WHO, GenevaGoogle Scholar
  14. 14.
    Renwick AG, Flynn A, Fletcher RJ et al (2004) Risk–benefit analysis of micronutrients. Food Chem Toxicol 42(12):1922–2004Google Scholar
  15. 15.
    Roberfroid MB (2002) Global view on functional foods: European perspectives. Br J Nutr 88(Suppl 2):S133–S138CrossRefGoogle Scholar
  16. 16.
    Truhaut R (1991) The concept of the acceptable daily intake: an historical review. Food Addit Contam 8(2):151–162Google Scholar
  17. 17.
    Council US-National Research (1980) Risk assessment/safety evaluation of food chemicals, subcommittee on food toxicology. National Academy of Sciences Press, Washington, DCGoogle Scholar
  18. 18.
    Van Esch GJ, Kroes R (1984) Acceptable daily intake: Truhaut’s concept still acceptable today. Hommage to Professor René Truhaut, Paris, 19 October 1984 (Imprimerie Tardy, Quercy, Cahors), pp 1124–1127Google Scholar
  19. 19.
    WHO (1987) Principles for the safety assessment of food additives and contaminants in food. Environmental Health Criteria, n70. Geneva, WHOGoogle Scholar

Copyright information

© ILSI Europe 2009

Authors and Affiliations

  • Gérard Pascal
    • 1
  1. 1.Institut National de la Recherche Agronomique—INRANutrition Humaine et Sécurité AlimentaireParis Cedex 07France

Personalised recommendations