ArticleEFSA journal. European Food Safety Authority2022
Guidance on the use of the benchmark dose approach in risk assessment.
Article in EFSA journal. European Food Safety Authority, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 109 papers, 2 of them syntheses that pooled it.
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109 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Toward Explainable Carcinogenicity Prediction: An Integrated Cheminformatics Approach and Consensus Framework for Possibly Carcinogenic Chemicals.Journal of chemical information and modeling · 2025Guideline
- Using systematic reviews for hazard and risk assessment of endocrine disrupting chemicals.Reviews in endocrine & metabolic disorders · 2015Pooled it
- Derivation of Provisional Chronic Oral Toxicity Values (PCOTV) for Novel Short-Chain PFAS Congeners.Journal of applied toxicology : JAT · 2026Review
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- Synergistic effects of combined exposure to hydroquinone and nitrofurantoin in T24 bladder cells: anArhiv za higijenu rada i toksikologiju · 2026Article
- Mutagenic and carcinogenic potency determinations for NDMA support the cumulative dose assumption underpinning the less-than-lifetime Threshold of Toxicological Concern.Archives of toxicology · 2026Article
- Overview of Current Regulatory and Methodological Approaches for the Risk Assessment of Mycotoxins.Toxins · 2026Review
- Update of the risk assessment on emerging and novel brominated flame retardants in food.EFSA journal. European Food Safety Authority · 2026Article
- Scientific Report on consumer health-based guidance values for trifluoroacetic acid.EFSA journal. European Food Safety Authority · 2026Article
- Principles of Food Safety and Toxicological Risk Assessment: Refining Hazards, Risk Management Communication, and Common Misconceptions.Comprehensive reviews in food science and food safety · 2026Review
- Scientific Opinion on waiving of the dog studies in the regulatory process of agrochemicals approval.EFSA journal. European Food Safety Authority · 2026Article
- A Method to Calibrate Chemical-Agnostic Quantitative Adverse Outcome Pathways on Multiple Chemical Data.Chemical research in toxicology · 2026Article
- Development of a QSAR model for predicting PPARα activation by PFAS based on human in vitro data of a comprehensive panel of legacy and novel PFAS.Archives of toxicology · 2026Article
- Glutamate: Safe and Adequate Intake Levels for Infants-Foods (Basel, Switzerland) · 2026Article
- Machine learning and free energy clustering reveal PAH protein binding linked to AD risk.iScience · 2026Article
- Benchmark Approach to Unravel Fluoride Toxicity: Liver and Kidney Disruptions in Subacutely Exposed Rats.Journal of xenobiotics · 2026Article
- Benchmark Response Values for Error-Corrected Sequencing Mutagenicity Assessment Technologies.Environmental and molecular mutagenesis · 2026Article
- Review on Predictive Models and Integration Strategies for Holistic Impact Assessment of Chemicals and Materials.Environmental science & technology · 2026Review
- Re-evaluation of sucralose (E 955) as a food additive and evaluation of a new application on extension of use of sucralose (E 955) in fine bakery wares.EFSA journal. European Food Safety Authority · 2026Article
- Rapid risk assessment on acute reference dose (ARfD) of cereulide in infants and information on acute consumption of infant formulae.EFSA journal. European Food Safety Authority · 2026Article
49 more citing papers are in PubMed but not listed here.
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25 authors.
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Abstract
The Scientific Committee (SC) reconfirms that the benchmark dose (BMD) approach is a scientifically more advanced method compared to the no-observed-adverse-effect-level (NOAEL) approach for deriving a Reference Point (RP). The major change compared to the previous Guidance (EFSA SC, 2017) concerns the Section 2.5, in which a change from the frequentist to the Bayesian paradigm is recommended. In the former, uncertainty about the unknown parameters is measured by confidence and significance levels, interpreted and calibrated under hypothetical repetition, while probability distributions are attached to the unknown parameters in the Bayesian approach, and the notion of probability is extended to reflect uncertainty of knowledge. In addition, the Bayesian approach can mimic a learning process and reflects the accumulation of knowledge over time. Model averaging is again recommended as the preferred method for estimating the BMD and calculating its credible interval. The set of default models to be used for BMD analysis has been reviewed and amended so that there is now a single set of models for quantal and continuous data. The flow chart guiding the reader step-by-step when performing a BMD analysis has also been updated, and a chapter comparing the frequentist to the Bayesian paradigm inserted. Also, when using Bayesian BMD modelling, the lower bound (BMDL) is to be considered as potential RP, and the upper bound (BMDU) is needed for establishing the BMDU/BMDL ratio reflecting the uncertainty in the BMD estimate. This updated guidance does not call for a general re-evaluation of previous assessments where the NOAEL approach or the BMD approach as described in the 2009 or 2017 Guidance was used, in particular when the exposure is clearly lower (e.g. more than one order of magnitude) than the health-based guidance value. Finally, the SC firmly reiterates to reconsider test guidelines given the wide application of the BMD approach.
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