Abstract
The safety assessment of chemicals added or found in food has traditionally made use of data from in vivo studies performed on experimental animals. The nature and amount of data required to carry out a risk assessment is generally stipulated either in the different food legislations or in sectoral guidance documents. However, there are still cases where no or only limited experimental data are available or not specified by law, for example for contaminants or for some minor metabolites from active substances in plant protection products. For such cases, the Threshold of Toxicological Concern (TTC) can be applied. This review explores the use of the TTC approach in food safety in the European Union, in relation to the different food sectors, legal requirements and future opportunities.
Highlights
Regulatory risk assessment of chemicals added or found in food and feed, has traditionally made use of data from in vivo studies performed on experimental animals
In vivo studies provide critical information on how chemicals are handled by the body, in terms of their absorption, distribution, metabolism and excretion (ADME). This type of studies is generally requested by risk assessment bodies for the safety evaluation of chemicals to be put on the European market de novo or that are in need of a re-evaluation
In the European Union (EU), the food sector is strictly controlled by legislation when it comes to the safety of chemicals intentionally added to food, plant protection products, food contact materials, novel foods, GM products, and for a substantial number of contaminants
Summary
Regulatory risk assessment of chemicals added or found in food and feed, has traditionally made use of data from in vivo studies performed on experimental animals Such studies aim at identifying and characterizing the potential of chemicals for inducing adverse effects following short or prolonged exposure, directly or through exposure in utero. In vivo studies provide critical information on how chemicals are handled by the body, in terms of their absorption, distribution, metabolism and excretion (ADME). This type of studies is generally requested by risk assessment bodies for the safety evaluation of chemicals to be put on the European market de novo or that are in need of a re-evaluation. For addressing the potential effects of these data-poor chemicals on human health, the use of alternative to animal tests approaches is often recommended
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