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Related Concept Videos

Drug Toxicity: Overview01:00

Drug Toxicity: Overview

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Drug toxicity quantifies the harm a compound causes to an organism, varying by dose and potentially impacting whole systems or specific organs like the liver. Toxic reactions may arise from venomous insect or spider bites, with effects ranging from mild symptoms to severe outcomes such as brain damage or death. Common forms of acute poisoning include ethanol intoxication and overdose of pain or fever medications, with substances like GHB and heroin being particularly lethal at doses close to...
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Toxicity Testing in Animals01:23

Toxicity Testing in Animals

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Toxicity tests in animals are grounded on two main assumptions: first, the effects observed in laboratory animals can be extrapolated to humans, especially when adjusted for body surface area; second, high-dose exposure in animals is essential to identify potential human hazards from lower doses. This is based on the quantal dose-response concept, which faces the challenge of extrapolating results from relatively few test animals to much larger human populations. For example, a 0.01% incidence...
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Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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Drug Regulation01:25

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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Drug Control Governance: Regulatory Bodies and Their Impact01:03

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Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
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The ability of a drug to produce structural deformations and functional abnormalities in the developing embryo or the fetus is called teratogenicity, and the drug producing this effect is known as a teratogen. Teratogenic effects include stillbirth, miscarriage, intrauterine growth restriction, and neurocognitive delay. A teratogen may affect the embryo at different stages of development, which is important in determining the type and extent of the damage. During blastocyst formation, the early...
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Detection of Mold in Food by Enzyme-Linked Immunosorbent Assay.

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Patulin Production by Some Fungal Species in Relation to Water Activity and Temperature.

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Related Experiment Video

Updated: Mar 25, 2026

Detection of Regulated Ergot Alkaloids in Food Matrices by Liquid Chromatography-Trapped Ion Mobility Spectrometry-Time-of-Flight Mass Spectrometry
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Worldwide regulations for ochratoxin A.

H P van Egmond1

  • 1National Institute of Public Health and Environmental Protection, Laboratory for Residue Analysis, Bilthoven, The Netherlands.

IARC Scientific Publications
|January 1, 1991
PubMed
Summary

Globally, 60 countries regulate mycotoxins in food and feed, with growing attention to ochratoxin A. Current regulations for ochratoxin A lack a strong scientific basis, necessitating rationalization.

Area of Science:

  • Food safety and toxicology
  • Regulatory science
  • Analytical chemistry

Background:

  • Mycotoxin regulations are established in approximately 60 countries, influencing food and animal feed safety standards.
  • Aflatoxins are the most commonly regulated mycotoxins, but regulatory scope is expanding to include others.
  • Ochratoxin A is a significant nephrotoxic mycotoxin, with regulatory limits proposed or enacted by at least 11 countries since 1990.

Purpose of the Study:

  • To review the current global regulatory landscape for mycotoxins, with a specific focus on ochratoxin A.
  • To assess the factors influencing the establishment of mycotoxin regulations.
  • To evaluate the scientific basis of existing ochratoxin A tolerance levels.

Main Methods:

  • Review of existing national and international regulations concerning mycotoxin levels in food and animal feed.

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  • Analysis of factors influencing regulatory development, including toxicological data, exposure assessments, and trade considerations.
  • Examination of the scientific literature and data supporting established ochratoxin A limits.

    • Main Results:

    • Approximately 60 countries have regulations for mycotoxins, primarily aflatoxins, with increasing numbers addressing other mycotoxins.
    • Ochratoxin A is the only regulated nephrotoxic mycotoxin, with limits ranging from 1-50 µg/kg for food and 100-1000 µg/kg for animal feed.
    • The scientific foundation for current ochratoxin A regulations appears to be weak.

    Conclusions:

    • The global regulatory framework for mycotoxins is evolving, reflecting increased awareness and analytical capabilities.
    • Existing regulations for ochratoxin A, while present in numerous countries, require strengthening based on robust scientific evidence.
    • Rationalization of ochratoxin A tolerance levels is crucial for consistent and scientifically sound food and feed safety.