Specific effects on the thyroid relevant for performing a dietary cumulative risk assessment of pesticide residues: 2024 update
In: EFSA journal, Band 22, Heft 3
ISSN: 1831-4732
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In: EFSA journal, Band 22, Heft 3
ISSN: 1831-4732
In: EFSA journal, Band 18, Heft 4
ISSN: 1831-4732
In: EFSA journal, Band 20, Heft 10
ISSN: 1831-4732
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.
BASE
In: EFSA journal, Band 22, Heft 7
ISSN: 1831-4732
Abstract
The EFSA Scientific Committee has updated its 2010 Guidance on risk–benefit assessment (RBA) of foods. The update addresses methodological developments and regulatory needs. While it retains the stepwise RBA approach, it provides additional methods for complex assessments, such as multiple chemical hazards and all relevant health effects impacting different population subgroups. The updated guidance includes approaches for systematic identification, prioritisation and selection of hazardous and beneficial food components. It also offers updates relevant to characterising adverse and beneficial effects, such as measures of effect size and dose–response modelling. The guidance expands options for characterising risks and benefits, incorporating variability, uncertainty, severity categorisation and ranking of different (beneficial or adverse) effects. The impact of different types of health effects is assessed qualitatively or quantitatively, depending on the problem formulation, scope of the RBA question and data availability. The integration of risks and benefits often involves value‐based judgements and should ideally be performed with the risk–benefit manager. Metrics such as Disability‐Adjusted Life Years (DALYs) and Quality‐Adjusted Life Years (QALYs) can be used. Additional approaches are presented, such as probability of all relevant effects and/or effects of given severities and their integration using severity weight functions. The update includes practical guidance on reporting results, interpreting outcomes and communicating the outcome of an RBA, considering consumer perspectives and responses to advice.
In: EFSA journal, Band 17, Heft 6
ISSN: 1831-4732
In: 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 , Kleiner , J , Rossi , A M , Serafimova , R , Reilly , L & Wallace , H M 2019 , ' Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment ' , EFSA Journal , vol. 17 , no. 6 , e05708 , pp. 1-17 . https://doi.org/10.2903/j.efsa.2019.5708
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.
BASE
In: EFSA journal, Band 19, Heft 8
ISSN: 1831-4732
In: EFSA journal, Band 17, Heft 3
ISSN: 1831-4732
In: EFSA journal, Band 21, Heft 1
ISSN: 1831-4732