CEC05-01 Basic concepts of Regulatory Toxicology (Theoretical lecture)

IF 2.9 3区医学 Q2 TOXICOLOGY

Toxicology letters Pub Date : 2025-09-01 DOI:10.1016/j.toxlet.2025.07.030

G. Kass

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Abstract

While history books contain numerous descriptions of intoxications due to the consumption of mycotoxins and exposure to heavy metals, regulatory toxicology only emerged in the early 20th century, when industrialization and the use of chemicals in everyday products and food raised concerns about their potential risks. In 1905, France pioneered its Law on the Repression of Fraud, followed in 1906 by the creation of the U.S. Food and Drug Administration (FDA), marking the first major step toward regulating toxic substances. However, it was only in the 1940s and 1950s that toxicology gained more recognition as a specialized field with the growth of the chemical and pharmaceutical industries and, in Europe, the establishment of national agencies and the development of safety standards. The formation of the European Union (EU) brought about a harmonized approach to chemical regulation with the creation of European Medicines Agency (EMA) (1995), the European Food Safety Authority (EFSA) (2002) and the European Chemicals Agency (ECHA) (2007).

The objective of regulatory toxicology is to protect human health and the environment. This requires the establishing of safe exposure limits, supported by appropriate toxicity testing that follow accepted guidelines. The key activities falling within the remit of regulatory toxicology include the following.

Hazard identification and characterisation: to understand the toxicological properties of substances by performing laboratory studies to test for short-term to long-term toxicity, reproductive-developmental toxicity, adverse effects on the genetic material and for other potential adverse effects. Where thresholds (Points of Departure) can be identified, these can be used to derive health-based guidance values.

Risk Assessment: to determine the level of risk associated with exposure to a particular substance.

Risk Management: to establish appropriate safety standards, labelling requirements and restrictions on the use of harmful substances.

This first introductory presentation will set the scene for the CEC5 ‘Regulatory Toxicology in the context of the EU Legislations’

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CEC05-01调节性毒理学基本概念（理论讲座）

虽然历史书中有许多关于因食用真菌毒素和接触重金属而中毒的描述，但监管毒理学直到20世纪初才出现，当时工业化和在日常产品和食品中使用化学品引起了人们对其潜在风险的担忧。1905年，法国率先制定了《打击欺诈法》，随后在1906年，美国食品和药物管理局（FDA）成立，标志着监管有毒物质的第一步。然而，直到20世纪40年代和50年代，随着化学和制药工业的发展，以及欧洲国家机构的建立和安全标准的制定，毒理学才作为一个专业领域得到了更多的认可。随着欧洲药品管理局（EMA）（1995年）、欧洲食品安全局（EFSA）（2002年）和欧洲化学品管理局（ECHA）（2007年）的成立，欧盟（EU）的形成带来了统一的化学品监管方法。管制毒理学的目标是保护人类健康和环境。这就要求建立安全的接触限度，并根据公认的准则进行适当的毒性试验。管制毒理学范围内的主要活动包括以下内容。危害识别和表征：通过进行实验室研究来了解物质的毒理学特性，以测试短期到长期毒性、生殖发育毒性、对遗传物质的不利影响和其他潜在的不利影响。在能够确定阈值（起点）的情况下，可使用这些阈值来得出基于健康的指导值。风险评估：确定与接触特定物质有关的风险水平。风险管理：对有害物质的使用建立适当的安全标准、标签要求和限制。第一次介绍性演讲将为CEC5“欧盟立法背景下的监管毒理学”奠定基础。

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