Open AccessGuidance on the use of the Threshold of Toxicological Concern approach in food safety assessment
Author(s) -
More Simon J,
Bampidis Vasileios,
Benford Diane,
Bragard Claude,
Halldorsson Thorhallur I,
HernándezJerez 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,
GundertRemy Ursula,
Kass George E N,
Kleiner Juliane,
Rossi Anna Maria,
Serafimova Rositsa,
Reilly Linda,
Wallace Heather M
Publication year - 2019
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2019.5708
Subject(s) - acceptable daily intake , toxicology , no observed adverse effect level , risk assessment , exposure assessment , reference dose , body weight , environmental health , medicine , biology , computer science , pesticide , computer security , agronomy
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.