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Regulatory Toxicology

Issues Relevant to Toxicology

  1. H. Paul A. Illing PhD, FIBiol, FRSC, FRSPH, FIOSH1,
  2. Timothy C. Marrs OBE, MD, DSc, FRCP, FRCPath, FBTS, FATS2,3,4

Published Online: 15 DEC 2009

DOI: 10.1002/9780470744307.gat114

General, Applied and Systems Toxicology

General, Applied and Systems Toxicology

How to Cite

Illing, H. P. A. and Marrs, T. C. 2009. Regulatory Toxicology. General, Applied and Systems Toxicology. .

Author Information

  1. 1

    Paul Illing Consultancy Services Ltd., Heswall, Wirral, Cheshire, UK

  2. 2

    Edentox Associates, Edenbridge, Kent, UK

  3. 3

    National Poisons Information Service (Birmingham Centre) and West Midlands Poisons Unit, Birmingham, UK

  4. 4

    University of Central Lancashire, Preston, Lancashire School of Health and Postgraduate Medicine, UK

Publication History

  1. Published Online: 15 DEC 2009

Abstract

Regulatory toxicology is the process whereby information relevant to the evaluation of the toxicity of agents is obtained by organizations and evaluated by or on behalf of governmental or international organizations. The aim is to protect workers, consumers, the public generally and the environment. The requirements of many regulatory systems are closely defined in terms of both the studies required and the interpretations to be placed upon the results obtained. There are various models for the regulation of chemicals, which may be based upon equity, utility or technical feasibility criteria, or a combination of these. Some chemicals are subject to premarketing authorization systems, so that the organization which wishes to market the substance needs permission before doing so. In most countries, the marketing of human and veterinary pharmaceuticals follows this pattern. Other systems have lists of allowed or proscribed substances or are simply notification schemes. With the latter, the individual substance does not need to be authorized but its use/sale/manufacture has to notified, together with the basic properties of the compound. There has been a recent trend to harmonize regulatory systems within trading blocks such as the European Union (EU) and North American Free Trade Area (NAFTA) and also between these blocks.

Keywords:

  • risk assessment;
  • risk management;
  • regulation;
  • pharmaceuticals;
  • veterinary medicines;
  • pesticides (plant protection products/biocides);
  • food additives/contaminants;
  • food contact materials;
  • industrial chemicals