Procedure for setting regulatory limits for contaminants in food Regulatory limits

The scientific risk assessment is an assessment of the risks related to the presence of a contaminant in foodstuffs for human health and is the basis for any and all measures to be taken. If the contaminant is not a genotoxic carcinogen, then a health-based guidance value is derived. Human exposure (average and 95th percentile) is assessed in relation to this health-based guidance value. Particular attention is paid to vulnerable groups within the population and to high-level consumers. The exposure assessment also identifies the foods/food groups that contribute significantly to exposure. The occurrence data are obtained for these foods and food groups following the application of good practices and used to determine the appropriate maximum level to be set for the protection of consumer health. Maximum levels are set at a strict level that is reasonably achievable when good agricultural, fishery and manufacturing practices are followed and that takes into account the risk related to the consumption of the food.

If the contaminant(s) is a genotoxic carcinogen or if current exposure of the population or of vulnerable groups in the population is close to or greater than the tolerable daily intake, then the maximum levels are set at a level that is "as low as reasonably achievable" (ALARA). These approaches ensure that food business operators apply measures that prevent and reduce contamination as much as possible to protect the public health. To protect infants and young children, a vulnerable group, the maximum levels are set as the lowest achievable through the strict selection of raw materials used to manufacture these foods. This strict selection of raw materials also is appropriate for the production of some specific foodstuffs, e.g., bran, for direct consumption.

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