Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment

Simon J. More, Vasileios Bampidis, Diane Benford, Claude Bragard, Thorhallur I. Halldorsson, Antonio F. Hernández-Jerez, Susanne Hougaard Bennekou, Kostas P. Koutsoumanis, Kyriaki Machera, Hanspeter Naegeli, Søren S. Nielsen, Josef R. Schlatter, Dieter Schrenk, Vittorio Silano, Dominique Turck, Maged Younes, Ursula Gundert-Remy, George E.N. Kass, Juliane Kleiner, Anna Maria Rossi & 4 others Rositsa Serafimova, Linda Reilly, Heather M. Wallace, EFSA Scientific Committee

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

The Scientific Committee confirms that the Threshold of Toxicological Concern (TTC) is a pragmatic screening and prioritisation tool for use in food safety assessment. This Guidance provides clear step-by-step instructions for use of the TTC approach. The inclusion and exclusion criteria are defined and the use of the TTC decision tree is explained. The approach can be used when the chemical structure of the substance is known, there are limited chemical-specific toxicity data and the exposure can be estimated. The TTC approach should not be used for substances for which EU food/feed legislation requires the submission of toxicity data or when sufficient data are available for a risk assessment or if the substance under consideration falls into one of the exclusion categories. For substances that have the potential to be DNA-reactive mutagens and/or carcinogens based on the weight of evidence, the relevant TTC value is 0.0025 μg/kg body weight (bw) per day. For organophosphates or carbamates, the relevant TTC value is 0.3 μg/kg bw per day. All other substances are grouped according to the Cramer classification. The TTC values for Cramer Classes I, II and III are 30 μg/kg bw per day, 9 μg/kg bw per day and 1.5 μg/kg bw per day, respectively. For substances with exposures below the TTC values, the probability that they would cause adverse health effects is low. If the estimated exposure to a substance is higher than the relevant TTC value, a non-TTC approach is required to reach a conclusion on potential adverse health effects.

Original languageEnglish
Article numbere05708
JournalEFSA Journal
Volume17
Issue number6
DOIs
Publication statusPublished - 6 Jun 2019

Fingerprint

safety assessment
Food Safety
Toxicology
food safety
body weight
Body Weight
adverse effects
weight-of-evidence
toxicity
food law
prioritization
carbamates
organophosphorus compounds
carcinogens
chemical structure
committees
risk assessment
Food Legislation
screening
Decision Trees

Keywords

  • Cramer classification scheme
  • risk assessment
  • Threshold of toxicological concern

ASJC Scopus subject areas

  • Parasitology
  • Food Science
  • Microbiology
  • Animal Science and Zoology
  • veterinary (miscalleneous)
  • Plant Science

Cite this

More, S. J., Bampidis, V., Benford, D., Bragard, C., Halldorsson, T. I., Hernández-Jerez, A. F., ... EFSA Scientific Committee (2019). Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment. EFSA Journal, 17(6), [e05708]. https://doi.org/10.2903/j.efsa.2019.5708

Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment. / More, Simon J.; Bampidis, Vasileios; Benford, Diane; Bragard, Claude; Halldorsson, Thorhallur I.; Hernández-Jerez, Antonio F.; Hougaard Bennekou, Susanne; Koutsoumanis, Kostas P.; Machera, Kyriaki; Naegeli, Hanspeter; Nielsen, Søren S.; Schlatter, Josef R.; Schrenk, Dieter; Silano, Vittorio; Turck, Dominique; Younes, Maged; Gundert-Remy, Ursula; Kass, George E.N.; Kleiner, Juliane; Rossi, Anna Maria; Serafimova, Rositsa; Reilly, Linda; Wallace, Heather M.; EFSA Scientific Committee.

In: EFSA Journal, Vol. 17, No. 6, e05708, 06.06.2019.

Research output: Contribution to journalArticle

More, SJ, Bampidis, V, Benford, D, Bragard, C, Halldorsson, TI, Hernández-Jerez, AF, Hougaard Bennekou, S, Koutsoumanis, KP, Machera, K, Naegeli, H, Nielsen, SS, Schlatter, JR, Schrenk, D, Silano, V, Turck, D, Younes, M, Gundert-Remy, U, Kass, GEN, Kleiner, J, Rossi, AM, Serafimova, R, Reilly, L, Wallace, HM & EFSA Scientific Committee 2019, 'Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment', EFSA Journal, vol. 17, no. 6, e05708. https://doi.org/10.2903/j.efsa.2019.5708
More SJ, Bampidis V, Benford D, Bragard C, Halldorsson TI, Hernández-Jerez AF et al. Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment. EFSA Journal. 2019 Jun 6;17(6). e05708. https://doi.org/10.2903/j.efsa.2019.5708
More, Simon J. ; Bampidis, Vasileios ; Benford, Diane ; Bragard, Claude ; Halldorsson, Thorhallur I. ; Hernández-Jerez, Antonio F. ; Hougaard Bennekou, Susanne ; Koutsoumanis, Kostas P. ; Machera, Kyriaki ; Naegeli, Hanspeter ; Nielsen, Søren S. ; Schlatter, Josef R. ; Schrenk, Dieter ; Silano, Vittorio ; Turck, Dominique ; Younes, Maged ; Gundert-Remy, Ursula ; Kass, George E.N. ; Kleiner, Juliane ; Rossi, Anna Maria ; Serafimova, Rositsa ; Reilly, Linda ; Wallace, Heather M. ; EFSA Scientific Committee. / Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment. In: EFSA Journal. 2019 ; Vol. 17, No. 6.
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