What is it about?
Infant formula products are strictly evaluated and regulated by many authorities, including Codex, US FDA and the European Commission. Within Codex, additive safety evaluation is undertaken by the Joint Expert Committee on Food Additives (JECFA). This evaluation is based on the derived Acceptable Daily Intake (ADI), though the ADI is generally not applicable for infants <12 weeks of age. The existing toxicological data for selected food additives have been compiled and reviewed, focusing on the suitability of the data to support safe use in early life.
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Why is it important?
Analysis of these data suggests that the necessity to generate additional data depends on knowledge of use levels and intakes, previous exposure in the target population addressing the requested use level, chemical nature of the additive, potential nutritional effects and its expected fate (ADME and digestion) in the infant.
Perspectives
In a multifaceted safety evaluation, taking into account the whole body of evidence, is essential to identify what additional data may be needed to ensure safety in early life. Defining good clinical data in terms of safety assessment for early life and investigating further if the approach can be used for complex ingredients, novel ingredients and contaminants.
Aaron O'Sullivan
University College Dublin
Read the Original
This page is a summary of: A science driven framework for the safety assessment of technologically justified food additives during early life, Toxicology Letters, October 2016, Elsevier,
DOI: 10.1016/j.toxlet.2016.07.550.
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