Safety Assessment of Functional Foods

  • Bobbie Bradford
Living reference work entry


The safety assessment of functional foods follows the same paradigm established for conventional foods consisting of an assessment of the intrinsic hazards associated with the food/food ingredient combined with knowledge about the expected exposure that will occur. Addressing safety concerns on single components is relatively straightforward. However, functional foods can be whole foods and/or may consist of multiple components with increasing complexity (Fig. 1) which results in a different strategy often being required depending on the type of food/food ingredient. Traditionally whole foods have been considered safe because no evidence has accumulated on adverse effects and/or any intrinsic hazards have been addressed by adequate processing/preparation techniques. For example, red kidney beans need to be soaked and boiled at high temperatures to ensure destruction of phytohemagglutinin associated with gastrointestinal adverse effects ( However, if these whole foods are exotic compared with the region where they are now to be marketed, then it was recognized that there needed to be governance and guidance in how to determine the safety of such food. These now fall into the category of novel foods which are legislated for in Canada, Australia and New Zealand, and Europe, all of which require a premarket assessment. Detailed information on the origin, production, composition, nutritional characteristics, and prior exposure to the novel food is required (Edwards 2005). The European Novel Foods legislation in May 1997 ( established the need for determining safety of exotic fruits and vegetables introduced to Europe after this date.


Quantitative Structure Activity Relationship Safety Assessment Plant Sterol European Food Safety Authority Quantitative Structure Activity Relationship 
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References and Further Reading

  1. Constable A, Jonas D, Cockburn A, Davi A, Edwards G, Hepburn P, Herouet-Guicheney C, Knowles M, Moseley B, Oberdörfer R, Samuels F (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):2513–2525CrossRefPubMedGoogle Scholar
  2. Edwards G (2005) Safety assessment of novel foods and strategies to determine their safety in use. Toxicol Appl Pharmacol 207:S623–S627CrossRefGoogle Scholar
  3. EFSA (2009) General principles for the collection of national food consumption data in the view of a pan-European dietary survey. EFSA J 7(12):1435. [51 pp].
  4. Ellwood K, Balentine DA, Dwyer JT, Erdman JW, Cortney Gaine P, Kwik Uribe CL (2014) Considerations on an approach for establishing a framework for bioactive food components. Adv Nutr 5:693–701CrossRefPubMedGoogle Scholar
  5. Harwood M, Danielewska-Nikie B, Borzelleca JF, Flamm GW, Williams GM, Lines TC (2007) A critical review of the data related to the safety of quercetin and lack of evidence of in vivo toxicity, including lack of genotoxic/carcinogenic properties. Food Chem Toxicol 45:2179–2205CrossRefPubMedGoogle Scholar
  6. Hendriks HFJ, Brink EJ, Meijer GW, Princen HMG, Ntanios FY (2003) Safety of long-term consumption of plant sterol esters-enriched spread. Eur J Clin Nutr 57:681–692CrossRefPubMedGoogle Scholar
  7. Howlett J, Edwards DG, Cockburn A, Hepburn P, Kleiner J, Knorr D, Kozianowski G, Muller D, Peijnenburg A, Perrin I, Poulsen M, Walker R (2003) The safety assessment of novel foods and concepts to determine their safety in use. Int J Food Sci Nutr 54(Suppl):S1–S32CrossRefGoogle Scholar
  8. Johanns ES, van der Kolk LE, van Gemert HM, Sijben AE, Peters PW, de Vries I (2002) An epidemic of seizures after consuming herbal tea. Ned Tijdschr Geneeskd 146(17):813–816PubMedGoogle Scholar
  9. Knudsen I, Søborg I, Eriksen F, Pilegaard K, Pedersen J (2008) Risk management and risk assessment of novel plant foods: concepts and principles. Food Chem Toxicol 46:1681–1705CrossRefPubMedGoogle Scholar
  10. Lea LJ, Hepburn P (2006) Safety evaluation of phytosterol-esters. Part 9: results of a European post-launch monitoring programme. Food Chem Toxicol 44(8):1213–1222CrossRefPubMedGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2015

Authors and Affiliations

  1. 1.UnileverMilton KeynesUK

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