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

EFSA Scientific Committee; 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; Rositsa Serafimova; Linda Reilly; Heather M Wallace

doi:10.2903/j.efsa.2019.5708

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

EFSA Scientific Committee, 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 KleinerAnna Maria Rossi, Rositsa Serafimova, Linda Reilly, Heather M Wallace

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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.

Originalsprog	Engelsk
Artikelnummer	e05708
Tidsskrift	EFSA Journal
Vol/bind	17
Udgave nummer	6
Sider (fra-til)	1-17
Antal sider	17
ISSN	1831-4732
DOI	https://doi.org/10.2903/j.efsa.2019.5708
Status	Udgivet - 1 jun. 2019

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10.2903/j.efsa.2019.5708

Guidance Threshold of Toxicological ConcernForlagets udgivne version, 1,9 MB

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Committee, EFSA. S., More, S. J., Bampidis, V., Benford, D., Bragard, C., Halldorsson, T. I., Hernández-Jerez, A. F., Hougaard Bennekou, S., Koutsoumanis, K. P., Machera, K., Naegeli, H., Nielsen, S. S., Schlatter, J. R., Schrenk, D., Silano, V., Turck, D., Younes, M., Gundert-Remy, U., Kass, G. E. N., ... Wallace, H. M. (2019). Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment. EFSA Journal, 17(6), 1-17. [e05708]. https://doi.org/10.2903/j.efsa.2019.5708

Committee, EFSAS, 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 2019, 'Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment', EFSA Journal, bind 17, nr. 6, e05708, s. 1-17. https://doi.org/10.2903/j.efsa.2019.5708

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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.",

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AU - More, Simon J

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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

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N2 - 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.

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KW - Threshold of toxicological concern

KW - risk assessment

KW - Cramer classification scheme

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

Abstract

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