# In Vitro New Approach Methodologies for Toxicity Assessment of Emerging Food Contaminants in Indonesia: A Proposed Strategy for BPOM Regulatory Integration
> Hardjo M.

URL kanonis: https://discover.unhas.ac.id/publications/pub_scopus_105046731498
Jurnal / Konferensi: Journal of Applied Toxicology
Tahun terbit: 2026
DOI: https://doi.org/10.1002/jat.70394
ISSN: 0260437X
Kuartil SJR: Q2
Citations: 0

## Authors
- Hardjo M.

## Abstract
The accelerating global diversification of food chemicals-encompassing mycotoxins, heavy metals, organophosphate pesticide residues and the increasingly prevalent burden of microplastics and nanoplastics (MNPs)-creates an urgent demand for rapid, human-relevant and ethically acceptable toxicity testing platforms. Conventional animal-based bioassays are insufficient to characterise the thousands of substances awaiting safety evaluation, a deficit particularly acute in tropical food-producing regions including Indonesia where environmental contamination profiles and regulatory infrastructure differ markedly from high-income countries. New approach methodologies (NAMs), comprising validated in vitro cell and organoid systems, high-throughput screening (HTS), multiomics toxicogenomics, in silico modelling and adverse outcome pathway (AOP) frameworks, represent a paradigm shift in food safety toxicology. This review critically appraises current evidence on in vitro NAMs for emerging food contaminants, with emphasis on (i) 2D cell line and 3D organoid/organ-on-chip models for hepatotoxicity, enterotoxicity and nephrotoxicity; (ii) mechanistic pathways-oxidative stress, mitochondrial dysfunction, genotoxicity and intestinal barrier disruption-as interrogated through standardised in vitro endpoints; (iii) AOP frameworks as regulatory bridges between molecular initiating events and adverse outcomes; (iv) high-throughput transcriptomics (HTTr) and Cell Painting integration for mechanism-informed hazard prioritisation; and (v) in vitro-to-in vivo extrapolation (IVIVE) via physiologically based toxicokinetic (PBTK) modelling. Critical gaps in chronic-exposure data, mixture toxicity assessment and BPOM regulatory acceptance are discussed. A novel evidence-based NAM validation roadmap tailored to the Southeast Asian regulatory context is proposed.

## Keywords
- Adverse Outcome Pathway
- Toxicogenomics
- Context (archaeology)
- Toxicity
- Biology
- In vitro toxicology
- Risk assessment
- Biotechnology
- Food safety
- Genotoxicity
- Computational biology
- Pharmacology
- Animal testing
- Reproductive toxicity
- Test strategy
- Toxicology
- Exposure assessment
- In silico
- Bioaccumulation
- Environmental health
- Microplastics
- Toxicokinetics
- Bioassay
- Bioinformatics
- Mitochondrial toxicity
- Risk analysis (engineering)
- Adverse effect
- Medicine
- Generally recognized as safe
- Physiologically based pharmacokinetic modelling
- Toxicodynamics
- Biochemical engineering

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Sumber: Discover Unhas — RIMS Universitas Hasanuddin.
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