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

DC FieldValueLanguage
dc.contributor.authorMore, Simon John-
dc.contributor.authorBampidis, Vasileios-
dc.contributor.authorBenford, Diane-
dc.contributor.authoret al.-
dc.date.accessioned2019-07-22T10:28:19Z-
dc.date.available2019-07-22T10:28:19Z-
dc.date.copyright2019 European Food Safety Authorityen_US
dc.date.issued2019-06-06-
dc.identifier.citationEFSA Journalen_US
dc.identifier.issn1831-4732-
dc.identifier.urihttp://hdl.handle.net/10197/10941-
dc.description.abstractThe 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.en_US
dc.language.isoenen_US
dc.publisherWileyen_US
dc.subjectThreshold of toxicological concernen_US
dc.subjectRisk assessmenten_US
dc.subjectCramer classification schemeen_US
dc.titleGuidance on the use of the Threshold of Toxicological Concern approach in food safety assessmenten_US
dc.typeJournal Articleen_US
dc.internal.authorcontactothersimon.more@ucd.ieen_US
dc.statusPeer revieweden_US
dc.identifier.volume17en_US
dc.identifier.issue6en_US
dc.identifier.doi10.2903/j.efsa.2019.5708-
dc.neeo.contributorMore|Simon John|aut|-
dc.neeo.contributorBampidis|Vasileios|aut|-
dc.neeo.contributorBenford|Diane|aut|-
dc.neeo.contributoret al.||aut|-
dc.description.othersponsorshipEuropean Food Safety Authorityen_US
dc.date.updated2019-07-22T08:50:09Z-
item.grantfulltextopen-
item.fulltextWith Fulltext-
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