TY - JOUR

T1 - Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment

AU - Committee, EFSA Scientific

AU - More, Simon J

AU - Bampidis, Vasileios

AU - Benford, Diane

AU - Bragard, Claude

AU - Halldorsson, Thorhallur I

AU - Hernández-Jerez, Antonio F

AU - Hougaard Bennekou, Susanne

AU - Koutsoumanis, Kostas P

AU - Machera, Kyriaki

AU - Naegeli, Hanspeter

AU - Nielsen, Søren S

AU - Schlatter, Josef R

AU - Schrenk, Dieter

AU - Silano, Vittorio

AU - Turck, Dominique

AU - Younes, Maged

AU - Gundert-Remy, Ursula

AU - Kass, George E N

AU - Kleiner, Juliane

AU - Rossi, Anna Maria

AU - Serafimova, Rositsa

AU - Reilly, Linda

AU - Wallace, Heather M

PY - 2019

Y1 - 2019

N2 - 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 ?g/kg body weight (bw) per day. For organophosphates or carbamates, the relevant TTC value is 0.3 ?g/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 ?g/kg bw per day, 9 ?g/kg bw per day and 1.5 ?g/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.

AB - 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 ?g/kg body weight (bw) per day. For organophosphates or carbamates, the relevant TTC value is 0.3 ?g/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 ?g/kg bw per day, 9 ?g/kg bw per day and 1.5 ?g/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.

KW - Threshold of toxicological concern

KW - risk assessment

KW - Cramer classification scheme

U2 - 10.2903/j.efsa.2019.5708

DO - 10.2903/j.efsa.2019.5708

M3 - Journal article

C2 - 32626331

VL - 17

SP - 1

EP - 17

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 6

M1 - e05708

ER -