An integrated approach to the safety assessment of food additives in early life

Abstract

During the development of international standards by the Codex Alimentarius Commission, infant foods and their constituent ingredients are subject to rigorous risk analysis and are strictly regulated by many authorities. Various jurisdictions have approved only a limited number of additives specifically with regard to infant foods to fulfill specific technical requirements of quality. As part of the approval process, a rigorous safety assessment is essential to confirm that the use of additives does not pose any health risk for the consumer. An acceptable daily intake (ADI) may be derived from the toxicological databases. However, the ADI may not be applicable to infants because of the possible developmental sensitivities and potentially high exposure scenarios, leading to possible lower margins of safety than would often be determined for adult populations. There is interest in defining better food safety assessment approaches for pre-weaned infants aged less than 12-16 weeks. To confirm safe use in infants, we reviewed the suitability of the existing safety databases of six additives with historical uses in infant nutrition products. To determine further toxicity testing strategies, it is necessary to understand whether the chemical used in the additives is identical to endogenous physiological metabolites and/or whether immature organs of infants are targets of toxicity. Combined with an in-depth review of the existing relevant toxicological and nutritional studies, this integrated approach will facilitate decision-making. We propose a decision tree as a tool within this approach to help guide appropriate data requirements and identify data gaps. In cases of reasonable uncertainty, studies of targeted juvenile should be considered to investigate the safe use levels in food products.

Ecotoxicological Assessment of Heavy Metal and Its Biochemical Effect in Fishes

“…In the head, gills, abdomen, tails, fins, and scales of the Hypophthalmichthys molitrix , the concentration of Pb was found maximum (15.60, 17.15, 20.20, 14.32, 20.10, and 22.50 mg/kg, respectively), while Cd showed the minimum concentration (0.032, 0.112, 0.112, 0.096, 0.064, and 0.016 mg/kg, respectively). The concentrations of lead, nickel, and iron, described by the WHO were above the permissible levels, while the concentrations of chromium, copper, zinc, and cadmium were below the permissible limits [ 25 – 28 ].…”

Natural Compounds With Antibacterial Activity Against Cronobacter spp. in Powdered Infant Formula: A Review

“…Table 4, along with health benefits that have been ascribed to them and pertinent toxicological data. The authors recognize that lack of knowledge about the metabolism of food additives old or new, difficulties in determining accurate levels of exposure, and susceptibility to toxicity have historically hindered safety assessments in the neonatal context (150). Likewise, the purported health benefits noted in Table 4 are largely derived from animal studies or human feeding trials conducted with children or adults, and extrapolation of results to the neonatal situation is challenging.…”

Ten-day and four-week toxicity and toxicokinetics studies of alpha-glycosyl isoquercitrin in juvenile Göttingen minipigs

“…According to Constable et al, 25 who recently extensively discussed an integrated approach to the safety assessment of food additives in early life, currently there is neither scientific consensus nor guidance from regulatory bodies on the most suitable animal species to address toxicological data gaps in the early life period. It is suggested that the early life stage of pigs is close to human early life stage.…”