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

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Title: Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment
Authors: More, Simon JohnBampidis, VasileiosBenford, Dianeet al.
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Date: 6-Jun-2019
Online since: 2019-07-22T10:28:19Z
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-bystep 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 lg/kg body weight (bw) per day. For organophosphates or carbamates, the relevant TTC value is 0.3 lg/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 lg/kg bw per day, 9 lg/kg bw per day and 1.5 lg/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.
Type of material: Journal Article
Publisher: Wiley
Journal: EFSA Journal
Volume: 17
Issue: 6
Copyright (published version): 2019 European Food Safety Authority
Keywords: Threshold of toxicological concernRisk assessmentCramer classification scheme
DOI: 10.2903/j.efsa.2019.5708
Language: en
Status of Item: Peer reviewed
Appears in Collections:Veterinary Medicine Research Collection

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