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Abstract The European Commission asked EFSA to deliver an opinion on the nutritional safety and suitability of a specific protein hydrolysate. It is derived from a whey protein concentrate and used in an infant and follow‐on formula manufactured by FrieslandCampina Nederland B.V., which submitted a dossier to the European Commission to request an amendment of Regulation (EU) 2016/127 with respect to the protein sources that may be used in the manufacture of infant and/or follow‐on formula. The protein hydrolysate under evaluation is sufficiently characterised with respect to the fraction of the hydrolysed protein. In the pertinent intervention study provided, an infant formula manufactured from the protein hydrolysate with a protein content of 2.4 g/100 kcal and consumed as the sole source of nutrition by infants for 3 months led to a growth equivalent to a formula manufactured from intact cow's milk protein with a protein content of 2.1 g/100 kcal. Data on gastrointestinal tolerance of the formula did not raise any concerns. No experimental data have been provided on the nutritional safety and suitability of this protein source in follow‐on formula. Given that it is consumed with complementary foods and the protein source is nutritionally safe and suitable in an infant formula that is the sole source of nutrition of infants, the Panel considers that the protein hydrolysate is also a nutritionally safe and suitable protein source for use in follow‐on formula. The Panel concludes that the protein hydrolysate under evaluation is a nutritionally safe and suitable protein source for use in infant and follow‐on formula, as long as the formula in which it is used contains a minimum of 2.4 g/100 kcal protein and complies with the compositional criteria of Regulation (EU) 2016/127 and the amino acid pattern in its Annex IIIA.

BackgroundStandard infant formulae often have higher protein content than breastmilk in order to compensate for potentially lower digestibility; excess protein intake may promote adverse effects later in life. A new partially hydrolyzed whey-based (pHF-W) follow-on formula (FoF) with age-adapted protein content was evaluated for growth and gastrointestinal (GI) tolerance in healthy infants.MethodsFormula-fed (FF) infants (n = 108) received standard pHF-W formula (1.9 g protein/100 kcal) from enrollment (age ≤ 30 days) until age 120 days followed by new pHF-W FoF (1.6 g protein/100 kcal) until 360 days. Weight gain velocity (WGV) (mean daily WG from enrollment to age 180 days) was compared to WHO growth standards and a breastfed (BF) reference group (n = 86) (non-inferiority margin –3 g/day). GI tolerance was assessed using a validated questionnaire (scale range 13−65).ResultsWGV in FF infants (mean ± SD 24.0 ± 4.4 g/day) was non-inferior to BF (23.7 ± 3.9 g/day) and WHO standards (all p ≤ 0.013). Weight-for-age, length-for-age, weight-for-length, and head circumference-for-age z-scores of FF infants were not significantly different from BF at any timepoint. Symptoms of GI intolerance were low (≤23) at all timepoints and similar between groups.ConclusionA new pHF-W FoF with age-adapted protein content fed sequentially after standard pHF-W infant formula is safe, well-tolerated, and promotes a healthy growth pattern consistent with BF infants and WHO standards during the first year of life.Clinical trial registration[https://clinicaltrials.gov/], identifier [NCT03276663].

Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on bovine milk osteopontin (bmOPN) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF concerns OPN derived from bovine whey. The NF is intended to be used at a maximum use level of 151 mg/L, in infant formula (IF), follow‐on formula (FoF) and ready‐to‐eat dairy‐based meals for children up to 35 months of age. As compared to the concentrations naturally present in cow’s milk and concentrations found in IF on the market reported in the literature, the proposed use level of the NF represents an about 10‐fold higher concentration of bmOPN. The intended use levels of the NF would provide bmOPN at a concentration within the range of human milk (hm) OPN. In a 6‐month study, 14, 72 and 140 mg bmOPN/L in reconstituted (as consumed) IF were given to 279 infants in order to study possible effects on frequency and severity of adverse events, and growth, formula intake and stool consistency. Despite that a number of inconsistencies and limitations were noted in the study report, the Panel considers that the results obtained from this study do not raise safety concerns. Considering the source of the NF, that neither the toxicological studies nor the provided infant study do raise safety concerns, and the low bmOPN plasma levels in infants resulting from the consumption of the NF, the Panel considers that the margin of exposure (i.e. 36) between the NOAEL of the subchronic toxicity study (1,200 mg/kg bw per day) and the highest P95 estimate for infants (33.4 mg/kg bw per day) is sufficient. The Panel concludes that the NF is safe under the proposed conditions of use.

Previous reviews of the effect of young child formulas on health outcomes in infants and toddlers have been inconclusive. In this study, we undertook a contemporary synthesis of studies investigating the effects of consuming fortified milk beverages (compared to cow’s milk or unfortified comparator formula) on growth and/or nutritional status in children 1–3 years of age. Five electronic databases were searched (PubMed, Web of Science, Scopus, ProQuest, and Cochrane Library) for randomised controlled trials comparing fortified milk against control milk in young children (9–48 months), published between January 1990 and June 2022. Outcomes were growth, body composition, biochemical markers, and/or nutritional status. Mean differences (MD) were pooled using random-effects meta-analysis where there were ≥3 studies. The risk of bias was assessed using the Cochrane Risk of Bias 2.0 tool. Nineteen articles (12 studies; n = 4795) met the inclusion criteria. Heterogeneity was substantial, likely attributable to considerable variation in study characteristics. Fortified milk was associated with increased weight gain (MD = 0.14 kg [95% CI 0.06, 021], p = 0.0003) compared with control milk. Subgroup analyses demonstrated increases in weight in lower-income countries, and in studies with intervention periods > 6 months. There were no effects of fortified milks on other anthropometric measures. Haemoglobin (MD = 3.76 g/L [95% CI 0.17, 7.34], p = 0.04) and ferritin (MD = 0.01 nmol/L [95% CI 0.00, 0.02], p = 0.02) concentrations were increased in infants consuming fortified milks. Fortified milk beverages appear to offer a safe and acceptable source of complementary nutrition as a short-term strategy for addressing nutritional deficits and may modestly promote weight gain in vulnerable populations when provided for periods > 6 months. This study was prospectively registered with PROSPERO (CRD42022339920) and funded by the Infant Nutrition Council.

The inappropriate concentration of copper (Cu) and zinc (Zn) in formulae for infants can lead to abnormal micronutrient intake and adverse health outcomes. This study aimed to determine the concentration of Cu and Zn in different formulae and evaluate the Cu/Zn ratio. Besides, the daily intake (DI) of both micronutrients was estimated. Cu and Zn concentration in 103 formulae for infants, available in the Polish market, were assessed using atomic absorption spectrometry. The estimated DI was calculated from the average energy requirements for the 0–6 months aged infants. The microelement content of formulae was mostly in good agreement with that declared by the manufacturer (5–10% variations compared to the labeled values). The Cu/Zn ratio ranged from 1:8 to 1:25. The estimated DI of Cu was in the range of 0.14–1.11 mg/day. Six (6.7%) of the formulae did not meet the recommended range of Cu intake, especially during the first month of life and in the case of formulae for special medical purposes. The estimated DI of Zn varied from 2.27–11.25 mg/day. In most cases, the concentration of Cu and Zn in infant formulae was within the recommended range. It would be advisable to consider monitoring the DI of Cu and reconsider the Cu content in formulae for infants in proportion to its expected consumption.

A healthy child passes through a process of growth and harmonious development, his environment and food quality representing determining premises of his health, especially during the first two years. When breastfeeding is impossible due to the absence of milk secretion installation or to an insufficient amount of maternal milk, the alternative sources of feeding consist either in the administration of milk formulas or, under precarious social-economical conditions, in cow milk. As each infant has its individual needs, there is a variety of milk formulas, such that to provide the infant an adequate quantitative and qualitative nutrition, optimum for a harmonious development. There are several categories of formulas, based on proteins from milk or soy, hydrolyzed proteins and amino acids, as well as differences between the products from each category.

Abstract Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the safety and suitability for use by infants of follow‐on formulae (FOF) based on cow's milk intact protein with a protein content of at least 1.6 g/100 kcal (rounded value) that meet otherwise the requirements of relevant EU legislation. If the formula under evaluation is considered to be safe and suitable for use by infants, the NDA Panel is also asked to advise on whether FOF based on goat's milk intact protein, soy protein isolates or protein hydrolysates are also safe and suitable for infants under the same conditions. The Panel concludes that the use of FOF with a protein content of at least 1.6 g/100 kcal from either intact cow's milk protein or intact goat's milk protein otherwise complying with the requirements of relevant EU legislation is safe and suitable for healthy infants living in Europe with an intake of complementary foods of a sufficient quality. This conclusion does not apply to infant formula (IF). The Panel also concludes that the safety and suitability of FOF with a protein content of at least 1.6 g/100 kcal manufactured from either protein hydrolysates or soy protein isolates cannot be established with the available data. The same conclusion applies to IF. The NDA Panel endorsed a draft of this scientific opinion on 14 December 2016 for public consultation. The draft document has been revised and updated according to the comments received, where appropriate.

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the essential composition of infant and follow-on formula. This opinion reviews the opinion provided by the Scientific Committee on Food in 2003 on the essential requirements of infant and follow-on formulae in light of more recent evidence and by considering the Panel’s opinion of October 2013 on nutrient requirements and dietary intakes of infants and young children in the European Union. The minimum content of a nutrient in formula proposed in this opinion is derived from the intake levels the Panel had considered adequate for the majority of infants in the first six months of life in its previous opinion and an average amount of formula consumed during this period. From a nutritional point of view, the minimum contents of nutrients in infant and follow-on formula proposed by the Panel cover the nutritional needs of virtually all healthy infants born at term and there is no need to exceed these amounts in formulae, as nutrients which are not used or stored have to be excreted and this may put a burden on the infant’s metabolism. Therefore, the Panel emphasises that maximum amounts should be interpreted not as target values but rather as upper limits of a range which should not be exceeded.

Abstract On request from the European Commission following an application by Dairy Goat Co‐operative (NZ) Ltd, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on the suitability of goat milk protein as a source of protein in infant and follow‐on formulae. The Panel considered compositional data of an infant and a follow‐on formula made from whole goat milk that retained the natural whey‐to‐casein ratio of goat milk, data from a double‐blind, randomised, controlled, three‐centre trial, and a re‐analysis of the data of the trial which formed the basis of a previous evaluation of the Panel. A study in 200 Australian infants, randomised to receive an infant formula with unmodified goat milk protein or a cow milk formula exclusively for at least four months and thereafter in addition to complementary food until 12 months did not show statistically significant or clinically relevant differences in weight, length or head circumference development. The growth pattern of formula‐fed infants differed, as expected, from that of the WHO growth standard in particular with respect to weight‐for‐length. The results of this study were supported by the results of the trial considered in the Panel's earlier assessment, in which, however, the sample size was insufficient to draw conclusions. The Panel concludes that protein from goat milk can be suitable as a protein source for infant and follow‐on formulae, provided the final product complies with the compositional criteria laid down in Directive 2006/141/EC.