Guidelines for Safety Assessments of Nutrient-related Food Additives

Abstract

The designation of food additives is based on risk assessment by the Food Safety Commission of Japan (FSCJ) and subsequent review by the Ministry of Health, Labour and Welfare. However, risk assessment of food additives for nutrient fortification, so-called nutrient-related food additives, requires consideration of their intrinsic characteristics, i.e. that a nutrient is biologically essential. Recently, the FSCJ have established novel guidelines for safety assessment of nutrient-related food additives based on special consideration of their safety. In these guidelines, as the main emphasis is on safety data for humans, concrete parameters for identifying adverse health effects in humans and methods for assessing the highest intake in human as an alternative point of departure to no observed adverse effect level (NOAEL) are described. This paper gives an outline of these guidelines focusing especially on safety assessment of nutrient-related food additives.