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Safety assessment of additives and ingredients for infants and young children


Nigel Baldwin*, Danika Martyn, Kirt R. Phipps
*Corresponding author
Intertek, Farnborough, United Kingdom


At the request of the European Commission (EC), the European Food Safety Authority (EFSA) will re evaluate all food additives currently approved for infants and young children.  EFSA has subsequently published guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age, which details exposure assessment principles and a decision tree approach to risk assessment.  A key consideration for the toxicological risk assessment is systemic availability, which for many additives and ingredients may result in expensive and lengthy reproductive and developmental toxicity studies being requested.  Exposure assessment becomes more complex for young children (compared with infants) due to an increasingly varied diet, who can have particularly high intakes of specific foods.  Experienced scientific judgement is crucial to ensure all aspects of this safety assessment are considered for new and existing food additives and ingredients.


Food ingredients and additives for infants (up to 1 year) and young children (1 to 3 years) require special considerations for their safety assessment.  Because risk = hazard x exposure, both must be assessed in this context.  Recently the European Food Safety Authority (EFSA) has been mandated by the European Commission (EC) to re-evaluate the safety of specific food additives which are currently, or had been previously, permitted in foods intended for this age group, which will be reviewed in this article.

This review will cover five key areas.  First, we will look at the mandates given by the EC to EFSA in relation to the specific re-evaluation of food additives (as well as contact materials, pesticides and contaminants) in foods for these age groups.  Second, we will provide an overview of the first stage of the EFSA process – the publication of guidelines for assessing safety for infants less than 16 weeks of age.  Third, we will briefly discuss how this new approach may be extrapolated to nutritional/physiological ingredients being developed and requiring approval (such as novel food ingredients).  Following this, ...

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