Abstract
Recently, the European Commission issued a Delegated Regulation updating the compositional and information requirements for infant and follow-on formulae that are to be applied at the latest in February 2021. This new regulation changes the status of docosahexaenoic acid (DHA) from an optional ingredient to a mandatory nutrient in these formulae at levels between 20 and 50mg/100kcal (0.5–1% of fatty acids). By contrast, arachidonic acid (ARA) becomes an optional nutrient. Following publication of the new regulation, global scientific experts have expressed concerns regarding the potential health risks of new infant formulae containing only DHA, especially at levels higher than those in breast milk and infant formulae marketed to date. Both DHA and ARA play a crucial role in infant development. First, breast milk, the gold standard for infant feeding, contains both DHA and ARA. Second, during development, the conversion of linoleic acid into ARA through desaturation steps is not sufficient to meet nutritional needs, especially in carriers of newly identified genetic variants in fatty acid desaturases, which weaken the biosynthetic production of ARA. Third, circulating levels of DHA and ARA in breastfed infants can only be matched with the addition of both fatty acids to formulae. And fourth, most studies performed to date have demonstrated that important physiological and developmental endpoints are sensitive to the ratio of dietary ARA:DHA. The precautionary principle applies when implementing the new EU regulation for infant and follow-on formulae. As a consequence, given the vulnerability of developing infants as well as the absence of conclusive evidence that formulae with at least 20mg DHA/100kcal, but no ARA, are safe and suitable to support the growth and development of infants similar to their breastfed peers, it remains necessary to still market formulas containing both ARA and DHA until proved otherwise.
Highlights
Nutritional deficiencies during the first 1000 days of life have a long-lasting impact on health status [1]
Among lipids contained in breast milk (BM), the long-chain polyunsaturated fatty acids (LCPUFA) arachidonic acid (ARA; 20:4n-6) and docosahexaenoic acid (DHA; 22:6n-3) are one of the key factors necessary for infants
In regard to visual development, trials performed with formulae containing a level of DHA close to the mean one in BM, i.e., 0.32% of total fatty acids, proved to be more likely to yield an improvement in visual maturation
Summary
Nutritional deficiencies during the first 1000 days of life have a long-lasting impact on health status [1]. The European Food Safety Authority (EFSA), on its end, considers that 100 mg DHA/day and 140 mg ARA/day are adequate for the majority of children until the age of 6 months, and 100 mg DHA/day until 24 months of age [6] Until recently, these recommendations had not been translated into a mandatory addition of DHA and ARA in infant formulae, neither at the global level by the Codex Alimentarius [7] nor by the European Union [8]. Elaborating on the basis of this EFSA opinion, the Commission Delegated Regulation (EU) 2016/127 that defines the latest compositional criteria for infant and follow-on formulae mandates addition of DHA in the exact levels recommended by the EFSA, while the addition of ARA remains optional.
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