Sääntelytoksikologia

Sääntelytoksikologia, or regulatory toxicology, is a specialized field that applies toxicological principles and data to support the development and implementation of regulations. Its primary goal is to protect human health and the environment from the adverse effects of chemical substances, biological agents, and physical hazards. This discipline bridges the gap between scientific understanding of toxicity and the practical needs of regulatory bodies responsible for risk assessment and management.

Regulatory toxicologists evaluate data from various sources, including in vitro studies, in vivo animal tests, epidemiological research, and in silico modeling. They assess the potential risks associated with exposure to specific substances in different contexts, such as consumer products, pesticides, pharmaceuticals, industrial chemicals, and food additives. This assessment involves determining hazard identification, dose-response relationships, exposure assessment, and risk characterization.

The outcomes of regulatory toxicology assessments inform decision-making processes for agencies like the European Chemicals Agency (ECHA), the U.S. Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). These decisions can lead to restrictions on the use of certain substances, requirements for labeling, establishment of exposure limits, or the approval or rejection of products.

Key activities in regulatory toxicology include preparing dossiers for chemical registration, conducting risk assessments for new and existing substances, reviewing scientific literature, and providing expert advice to policymakers. The field is dynamic, constantly evolving with new scientific methodologies and emerging toxicological concerns, such as endocrine disruption and nanomaterial safety.