Use Of Infant Formula Research Articles

Should we be concerned about the use of lactose-free infant formulas?

Should we be concerned about the use of lactose-free infant formulas?

Close Relations, Practitioners or Social Networks: What Affects the Selection of Infant Formula Products?

This study examines which factors influence the preferences of mothers seeking advice on the use of infant formula in feeding practices. The effects of their close social circle, medical professionals and social network forums on feeding choices were evaluated. Data were collected from 638 questionnaires from mothers and were statistically analyzed. Our findings suggest that age may influence the preference to seek advice from a close social circle over consulting with medical professionals (p-value = 0.019 < 0.05). The educational level and the number of children impact the preferences of using infant formula over combining it with breastfeeding (p-value = 0.000 < 0.05 and p-value = 0.004 < 0.05, respectively). The research contributes to the understanding of the complex interplay between various demographic and socioeconomic factors and the decision-making process of mothers based on multiple social and digital sources of influence. The research presents valuable insights for healthcare policymakers and professionals in supporting mothers and providing them with up-to-date information. Feeding information can be distributed through all the communication channels that were examined in this study to benefit different socio-economic groups and to contribute to the well-being of infants in the long-run.

Human milk oligosaccharides produced by synthetic biology

The benefits of human breast milk (HBM) to newborn growth, development, and overall health have been well investigated. As breastfeeding rate has declined significantly, the use of infant formula has risen and remains a significant component of the infant's diet. HBM contains several essential nutritional components, with human milk oligosaccharides (HMO) being the third most abundant following lactose and lipids. A diverse array of HMOs is known to exert great benefits in intestinal, immune, and cognitive functions. In contrast to HBM, infant formula containing mainly bovine milk lacks the diversity of HMOs. Efforts have been made to replicate this characteristic in infant formula through chemical and chemoenzymatic synthesis as well as microbial production. Utilizing microbial hosts appears to be more favourable due to its accessibility and cost-efficiency. Escherichia coli has been preferably used due to its high incorporation of DNA, high-level expression capability, and rapid growth. However, potential endotoxin contamination raises health concerns and prevents approval as Generally Recognized as Safe (GRAS) by the FDA. This prompts the use of other microbes such as Bacillus subtilis. Future research in this area is needed to optimize effective procedures using microbial hosts, high yield production, and economic feasibility. This may lead to infant formulas closely mimicking HBM and its health benefits.

Health professionals' counselling on the use of infant formula: A scoping review.

Many parents experience lack of support and access to resources on how to prepare, handle, and provide formula milk to their infants. The purpose of this scoping review was to map and describe key information in existing research about how healthcare professionals receive information and how they inform and counsel parents about formula milk. A scoping review fulfilling the PRISMA-ScR checklist criteria used systematic searches targeting the study objective in the databases Embase, MEDLINE, and CINAHL on February 8th and 9th, 2022. Six studies with 959 participants in total were included. The research designs were focus group studies with and without combining individual interviews, an individual interview study, a study consisting of individual interviews and ethnographic observations, a survey, and a two-phase study consisting of a qualitative interview and a quantitative survey. Findings indicate lack of evidence-based information provided about infant formula by health care professionals when they counsel parents on formula feeding. Few studies focus on how healthcare professionals inform and counsel parents about formula milk. Health authorities should provide more evidence-based information to make formula feeding more feasible. Due to conflicting and omitted information, mothers often receive poor counselling on formula feeding.

FLUOROSIS PREVALENCE AT DIFFERENT REGIONS OF THE EARTH (LITERATURE REVIEW)

The aim of the study is to analyze the literature about the fluorosis prevalence and the factors which lead to dental and bone fluorosis. The search for articles published in 2016-2023 was conducted by the authors in Scopus and Web of Science scientific data bases using the keywords “fluorosis”, “dental fluorosis”. To classify the severity of dental fluorosis, the index of developmental defects of enamel (DDE), the index of tooth surface fluorosis (TSIF), and mostly Dean’s index Thylstrup &amp; Fejerskov Index (TFI) are used. The risk factors for dental fluorosis include living in regions with high level of fluoride, drinking water with high level of fluoride or salt fluoridation, drinking bottled water, use of fluoride toothpastes among preschool children, early weaning, and use of infant formula for long time, and, as well as, a hot climate and high fluoride content in soil and food. The studies from India and China demonstrated that the average concentration of dental fluorosis and skeletal fluorosis at fluoride contained 6 mg/l. The prevalence of dental fluorosis in NorthernTanzania, where the fluorine content in daily drinking water is 3.6 mg/l, reaches 75,22%. In Ethiopia, where fluorine content is 5.09 mg/l, the prevalence of skeletal fluorosis ranges from 55.1% to 72.4%. In Kenya, the fluoride content in drinking water reaches 72 mg/l, so the prevalence of dental fluorosis is 80%. The prevalence of dental fluorosis is lower in South Western Saudi Arabia and Iran where fluoride level is lower. In Jordan, the prevalence of dental fluorosis reaches 39.9% due to the high fluoride content in miner rocks. Skeletal fluorosis is wide spread in some areas of Pakistan due to the contamination of ground water by industrial production. The prevalence of mild dental fluorosis is 39% in New castle where water is fluoridated, and 24% in non-fluoridated Manchester in England. Dean’s index and TFI index are mostly used to classify these variety of fluorosis. Various factors affect the appearance of dental and bone fluorosis worldwide, so the prevalence of fluorosis varies from 11,1 up to 100%.

Use of baby food products during the complementary feeding period: What factors drive parents' choice of products?

It is recommended that infants are introduced to complementary foods from 6 months old, moving from a solely milk diet to eating a family diet by 12 months old. Although home cooking of family foods is recommended, a rapidly growing market producing baby food products (BFP) such as jars, pouches and snacks has developed. These are often accompanied by marketing claims around nutritional, health and developmental impacts despite research highlighting high sugar content. Although numerous studies have explored drivers of infant formula choice and use, little research has examined the drivers of BFP use. This study used an online survey for United Kingdom parents of infants aged 4-12 months to explore use of BFP alongside perceptions and drivers to purchase products. Overall, 271 parents participated (173 used BFP and 98 did not), with a descriptive analysis of closed items and a thematic analysis for open ended text conducted. The top motivators for using BFP were convenience, time saving, and baby's perceived enjoyment of products. The most purchased puree was fruit based and the most purchased baby snacks were vegetable puffs/sticks, with snack purchases being more common than purees in this sample. Aspects such as perceived healthiness drove choice, with snack foods being seen to enhance self-feeding skills, appetite regulation and motor development. Those who did not use BFP did not trust them and preferred to feed their baby home cooked foods. The findings are important for professionals working with parents, to support them through the transition to solid foods, particularly around raising awareness of marketing techniques and how to check content of foods to make a more informed choice.

An expert panel on the adequacy of safety data and physiological roles of dietary bovine osteopontin in infancy.

Human milk, due to its unique composition, is the optimal standard for infant nutrition. Osteopontin (OPN) is abundant in human milk but not bovine milk. The addition of bovine milk osteopontin (bmOPN) to formula may replicate OPN's concentration and function in human milk. To address safety concerns, we convened an expert panel to assess the adequacy of safety data and physiological roles of dietary bmOPN in infancy. The exposure of breastfed infants to human milk OPN (hmOPN) has been well-characterized and decreases markedly over the first 6 months of lactation. Dietary bmOPN is resistant to gastric and intestinal digestion, absorbed and cleared from circulation within 8-24 h, and represents a small portion (<5%) of total plasma OPN. Label studies on hmOPN suggest that after 3 h, intact or digested OPN is absorbed into carcass (62%), small intestine (23%), stomach (5%), and small intestinal perfusate (4%), with <2% each found in the cecum, liver, brain, heart, and spleen. Although the results are heterogenous with respect to bmOPN's physiologic impact, no adverse impacts have been reported across growth, gastrointestinal, immune, or brain-related outcomes. Recombinant bovine and human forms demonstrate similar absorption in plasma as bmOPN, as well as effects on cognition and immunity. The panel recommended prioritization of trials measuring a comprehensive set of clinically relevant outcomes on immunity and cognition to confirm the safety of bmOPN over that of further research on its absorption, distribution, metabolism, and excretion. This review offers expert consensus on the adequacy of data available to assess the safety of bmOPN for use in infant formula, aiding evidence-based decisions on the formulation of infant formula.

Prevalence and determinants of continued breastfeeding beyond 6 months among Algerian women. Evidence for Multiple Indicators Cluster Surveys

Breastfeeding is considered the best nutrition for infants and plays a significant role in a child's growth and development. In this regard, the World Health Organization (WHO) strongly recommends exclusive breastfeeding for the first 6 months of life, as well as continued breastfeeding when safe and appropriate complementary foods are introduced, up to 2 years of age or beyond. Nonetheless, breastfeeding practices remain sub-optimal in many parts of the world. In this respect, many children have shown not to be breastfed up to 6 months of age or are not breastfed during their first hours of life or are weaned too early. This allows for the use of infant formula, which can be life threatening due to poor hygiene, storage conditions or inappropriate foods. Likewise, breastfeeding rates in the Middle East and North Africa (MENA) region are lower than the global average. In Algeria, the breastfeeding rate up to 6 months of age is among the lowest in the world according to previous Multiple Indicators Cluster Surveys (MICS) reports. In addition, by the end of the sixth month, the percentage of children exclusively breastfed is less than 3% and only 23% of children receive breast milk at 22-23 months. The median duration of breast-feeding is 12 weeks. However, the socio-demographic factors associated with this sub-optimal breastfeeding practice are not explored in these reports, as studies and research conducted in this context using other data are few and mostly conducted in limited geographical areas. This stands for a descriptive cross-sectional study of all children who were breastfed in the MICS database, carried out in 2019, 8 709 children, including 4 471 boys and 4 238 girls, registered in the database. To explore factors associated with the duration of breastfeeding, we only included weaned children to minimize bias related to children who were still breastfeeding. This allowed to analyze data from 3 761 children, including 1 930 boys (5.4%) and 1,831 girls (48.6%). Through using a logistic regression model, we could attain the assessment of the role of different socio-demographic, economic and geographical factors in the maintenance of breastfeeding beyond 6 months. The prevalence of breastfeeding is 81.1%; the rate of exclusive breastfeeding of children aged 0-6 months is 28.7%. The factors associated with breastfeeding beyond six months are area of residence, mother's occupational status and wealth quintile. In fact, rural area appears to be a factor favoring the continuation of breastfeeding beyond six months, compared with urban area (OR = 1.29; CI [1.032-1.369]). Mothers living in the Eastern Highlands geographic region appear to be 1.56 times more likely to maintain breastfeeding for more than six months compared to those living in the Southern region (OR = 1.56; CI [1.123 - 1.677]). Children of non-working mothers are almost 1.5 times more likely to be breastfed after 6 months than those of working mothers (OR = 1.489; CI [1.107 - 1.947]). Parents belonging to the "richest" wealth quintiles appear to increase the chance of continued breastfeeding after 6 months with a 1.24-fold increase compared to those belonging to the "poorest" quintile (OR = 1.24; CI [1.086 - 1.812]). Factors such as the child's gender, maternal education level, and functional difficulties do not appear to be determining factors for the continuation of breastfeeding after six months. The prevalence and factors associated with the initiation and continuation of breastfeeding vary from one country to another. Notwithstanding the numerous studies to better comprehend mothers' breastfeeding behaviour and various initiatives for promotion thereof, many countries have low rates. In consequence, the downward trend in breastfeeding is directly linked to advances in the production and marketing of industrial milks, the lack of information and awareness among mothers and the lack of training of health professionals. In this respect, it is highly recommended to encourage behavioural changes, to improve communication about the duration of breastfeeding, to increase the use of postnatal counselling and training of paramedical staff according to the recommendations with support for mothers.This study is of great interest in developing countries like Algeria, in order to adopt preventive interventions, and to organise communication and pre- and post-natal counselling in the breastfeeding project. Clearly, this study should be enhanced with supplementary qualitative studies concerning the factors contributing to early discontinuation of breastfeeding.

Alimentation infantile et changements climatiques: une opportunité prometteuse.

The method of infant feeding has consequences for the production of greenhouse gases (GHG) as well as for the risks to infants posed by climate change. Breastfeeding can reduce the carbon footprint associated with the use of commercial infant formula by nearly 50% while reducing its water footprint and waste. It is also an excellent way of coping with emergencies associated with climate change, such as water shortages, since breastfed children are better protected than those fed with formula. To ensure that the protection offered by breastfeeding can be realized, we present elements that can help decision-makers seize a promising opportunity: improve infant feeding support for women and families.

Structure and digestibility of bovine casein complexes formed by enriching κ- and β-caseins in micellar casein concentrate together with minerals adjustment

Colloidal structure and infant in vitro gastrointestinal digestibility of casein complexes simulating caseins and minerals compositions of human casein micelles were studied. κ- and β-Caseins were fractionated from bovine micellar casein concentrate (MCC), and mixed with MCC to increase their ratios to 20% and 68%, followed by adding citrate (Cit), calcium (Ca), and inorganic phosphate (Pi) to obtain the casein complexes. The complexes enriched with κ- and β-caseins showed higher percentages of serum Ca, Pi and caseins, larger particle size, and looser internal structure. During gastric digestion, the complexes enriched with κ- and β-caseins formed smaller and looser coagula, which promoted degradation of intact caseins and formation of free amino groups and small peptides. During initial intestinal digestion, the complexes enriched with κ- and β-caseins formed more free amino groups and smaller peptides. These results offered a potential strategy to form human casein micelles analogues for use in infant formula.

A 21-day safety evaluation of biotechnologically produced 3-fucosyllactose (3-FL) in neonatal farm piglets to support use in infant formulas

3-Fucosyllactose (3-FL) is one of the most abundant fucosylated oligosaccharides in human breast milk and is an approved infant formula ingredient world-wide. 3-FL functions as a prebiotic to promote early microbial colonization of the gut, increase pathogen resistance and modulate immune responses. To investigate safety and potential gut microbiota effects, 3-FL was fed for 21-days to farm piglets beginning on Postnatal Day (PND) 2. Fructooligosaccharide (FOS), an approved infant formula ingredient, was used as a reference control. Standard toxicological endpoints were evaluated, and the gut microbiota were assessed. Neither 3-FL (245.77 and 489.72 mg/kg/day for males and 246.57 and 494.18 mg/kg/day for females) nor FOS (489.44 and 496.33 mg/kg/day males and females, respectively) produced any adverse differences in growth, food intake or efficiency, clinical observations, or clinical or anatomic pathology changes. Differences in the gut microbiota after 3-FL consumption (versus control and FOS groups) included the absence of Bifidobacterium species from the piglets, enrichment of Prevotellamassilia timonensis, Blautia species, Mediterranea massiliensis, Lachnospiraceae incertae sedis, and Eubacterium coprostanoligens and lower relative abundance of Allisonella histaminiformans and Roseburia inulinivorans. This study further supports the safe use of 3-FL produced using biotechnology as a nutritional ingredient in foods.

Cross-Sectional Analysis of Infant Diet, Outcomes, Consumer Behavior and Parental Perspectives to Optimize Infant Feeding in Response to the 2022 U.S. Infant Formula Shortage.

An anonymous, electronic, cross-sectional, retrospective survey was used. U.S. parents (n = 178) whose infants were ~10 weeks old during the shortage completed the survey. Of parents, 81% switched formulas during the shortage, 87% switched because they could not find the formula they typically used, 34% switched 3-5 times, 29% of parents visited ≥4 stores/24 h and 26% of parents traveled >20 miles/24 h to purchase formula. Use of infant formula increased (p < 0.01); in infants requiring specialty formula, use of intact cow's milk formula increased (p < 0.05) and use of premature infant formulas decreased (p < 0.05). Infants relying on specialty formulas experienced at least one undesirable outcome compared with non-specialty users. Parents used social media, relatives/friends and healthcare providers for support during the shortage, but their helpfulness scores were suboptimal. Parents reported the need for greater infant formula availability, free prenatal lactation education and postpartum lactation support. Government, regulatory and healthcare policy oversight are needed to protect the infant feeding system, including more commercially available products, access to banked donor milk and lactation support.

Australian Women's Experiences of Establishing Breastfeeding after Caesarean Birth.

Breastfeeding exclusivity and duration rates are lower after caesarean birth, yet the factors contributing to these are not well understood. This mixed-methods study used an anonymous online questionnaire to examine the facilitators and barriers to establishing breastfeeding as identified by Australian women after a caesarean birth. Quantitative data were reported using descriptive statistics, and multivariable models were used to determine the factors associated with breastfeeding outcomes including the timing of breastfeeding initiation, birth experience, and commercial infant formula use. Qualitative data were analysed using an inductive thematic analysis. Data were obtained for N = 961 women, of which <50% reported skin-to-skin contact during breastfeeding initiation. The barriers to breastfeeding included aspects of clinical care and reduced mobility, while unrushed care, partner support, and physical help with picking up the baby were helpful. Following a non-elective caesarean birth, women had half the odds of early breastfeeding initiation (OR = 0.50; 95% CI: 0.36, 0.68; p ≤ 0.001) and 10 times the odds to report a negative birth experience (OR = 10.2; 95% CI: 6.88, 15.43; p < 0.001). Commercial milk formula use was higher in primiparous women (OR = 2.16; 95% CI: 1.60, 2.91; p < 0.001) and in those that birthed in a private hospital (OR = 1.67; 95% CI: 1.25, 2.32; p = 0.001). Pain and reduced mobility, as well as conflicting and rushed care, negatively impacted breastfeeding after a caesarean birth, while delayed breastfeeding initiation, higher pain ratings, and negative birth experiences were more common for women that birthed by non-elective caesarean. This study adds valuable insights into the physical, emotional, and clinical care needs of women in establishing breastfeeding after a surgical birth. Clinical staffing and care should be modified to include full access to partner support to meet the specific needs of breastfeeding women after a caesarean birth.

Risk factors for infant formula usage during the initial hospital stay in term and late pre-term neonates after implementation of a breastfeeding support program: A retrospective case–control study from a tertiary care hospital

Background: Infant formula usage in hospitals is inevitable in certain circumstances. We explored the high-risk groups who required formula during hospital stays during the post-intervention phase of a quality improvement initiative for improving exclusive breastfeeding (EBF) rates in hospitals. Methods: A retrospective and case–control study was conducted involving 50 cases of neonates who received infant formula and 200 control who were exclusively breastfed. Data regarding maternal and neonatal details were from breastfeeding assessment forms and case record which was collected prospectively during the program. We compared common risk factors between the two groups. Results: There was a strong association between infant formula usage and cesarean sections, assisted reproductive technology (ART) conceptions, multiple gestations, neonatal intensive care unit admissions, being small for gestational age, and being an infant of a diabetic mother. First-h breastfeeding was associated with a higher likelihood of EBF in the hospital. In the final model, ART conception, multiple gestations, and delayed initiation of breastfeeding were strong predictors of the use of infant formula in the hospital. Conclusion: Initiating breastfeeding within the 1st h promotes EBF. ART conception and multiple gestations remain strong risk factors for formula usage, the social, physiological, and genetic reasons for which will need to be studied in detail.

Third stage of the kangaroo method: exclusive breastfeeding and growth of preterm and/or low birth weight newborns.

To evaluate the rates of exclusive breastfeeding (EBF) and growth of preterm and/or low birth weight newborns during the third stage of the Kangaroo Method (TSKM), at discharge. Retrospective study in a reference public maternity hospital between Jan/2014 and Dec/2017, including the preterm (less than 37 weeks) and/or low birth weight (less than 2500 g) newborn infants. Information was collected from medical records. Statistics analysis was done in SPSS software. 482 infants were included and followed up at the TSKM ambulatory. The average gestational age was 33 weeks (variation: 24-39 weeks) and birth weight, 1715g (variation: 455-2830 g). EBF occurred in 336 (70.1%) infants at hospital discharge, and in 291 (60.4%) at TSKM discharge. Each additional day of hospital stay increased the chance of infant formula (IF) use by 9.3% at hospital discharge and by 10.3% at TSKM discharge. Staying in the Kangaroo Neonatal Intermediate Care Unit (KNICU) favored EBF at hospital discharge and TSKM discharge (p<0.001). Not performing the kangaroo position increased the chance formula administration to the newborn infant at hospital discharge by 11%. Weight gain and head circumference growth were higher in infants using formula (p<0.001). The length of hospital stay and not performing the kangaroo position favored the use of infant formula at hospital and TSKM discharge. Staying in the KNICU favored exclusive breastfeeding at hospital and TSKM discharge. Weight gain and HC growth were higher in newborns receiving infant formula.

Review on Key Features of Infant Feeding: Human Milk and Infant Formula

Human breast milk (HBM) is the finest source of nutrition for almost all infants. Breast milk as a bodily fluid has many benefits beyond somatic cell growth, including regulation of postnatal intestinal function, immune ontogeny, and brain development. However, breastfeeding is strongly recommended, breastfeeding may not always be possible, suitable or solely adequate1. Hence, Infant formula is often an alternative source of infant nutrition when breastfeeding is unacceptable or impossible. The composition of infant formula should be as close as possible to the composition of human breast milk, both in terms of content and chemical specification2. Infant formulas try to mimic the nutritional composition of breast milk as closely as possible. A number of substitutes to milk-based formula also exist. In this article, we review nutritional information for breast milk and infant formulas to help you better understand the importance of breastfeeding and the use of infant formulas up to 24 months of age when alternative feeding is required. In general, breast milk is the ideal food to ensure that an infant's nutritional needs are met.&#x0D; Keywords: breast milk; infant formula; type of infant formula; benefits

Formation of casein micelles simulating human milk casein composition from bovine caseins: Micellar structure and in vitro infant gastrointestinal digestion

Bovine casein micelles in infant formula differ from human micelles in composition, structure and digestion. Preparation conditions, micellar structure and in vitro gastrointestinal digestion under infant of casein micelles formed from bovine caseins but simulating human micelles were investigated. Bovine caseins were fractionated and formulated based on the composition of human caseins, i.e., at a ratio of 68:20:12 for β-, κ- and αs1-caseins. Citrate (Cit), calcium (Ca), and inorganic phosphate (Pi) were added into casein dispersions (0.4% caseins, w/v) to obtain casein micelles. Optical absorbances showed that the optimal conditions of formation were mineral addition in the order of Cit → Ca → Pi over three cycles and final concentrations of 2.1–2.8 mM Cit, 6.1–7.1 mM Ca and 1.5–3.0 mM Pi. For micelles formed using 2.3 mM Cit, 7.1 mM Ca, and 2.8 mM Pi (the average concentrations in human milk), the particle size, micellar hydration, internal structure and morphology were similar to those of human micelles, while the percentage of serum caseins was lower and the molar ratio of Ca:casein was higher. During the gastrointestinal digestion, the gastric flocs, free amino groups and molecular weight distribution of peptides were close to those of human micelles, with casein degradation rate being lower, while the flocs were smaller and the free amino groups and casein degradation rate were higher compared to bovine micelles. These results suggested a potential to form micelles with composition, structure and digestion close to human micelles for use in infant formula.

Safety of oil from Schizochytrium limacinum (strain TKD-1) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283.

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 the safety of Schizochytrium sp. (TKD-1) oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Schizochytrium sp. is a single-cell microalga. The strain TKD-1, used by the applicant (ATK Biotech Co. Ltd.), belongs to the species Schizochytrium limacinum. The NF is a mixture of triglycerides in which docosahexaenoic acid (DHA) represents 53%-61% of fatty acids. The applicant proposed to use the NF in infant formulae (IF) and follow-on formulae (FOF). The use levels proposed by the applicant were derived from Regulation (EU) 2016/127, which states the mandatory addition of DHA to IF and FOF at the level of 20-50 mg/100 kcal. S. limacinum was attributed the qualified presumption of safety (QPS) status with the qualification 'for production purposes only'. Data provided by the applicant demonstrated the absence of viable cells in the NF. No toxicological studies were performed with the NF. However, based on the available toxicological data on oils derived from Schizochytrium sp., the QPS status of the source of the NF, the production process, the composition of the NF and the absence of marine biotoxins and viable cells in the NF, the Panel considers there are no concerns with regard to toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use.

Safety of oil from Schizochytrium sp. (strain CABIO-A-2) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283.

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 the safety of Schizochytrium sp. (strain CABIO-A-2) oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. S. sp. is a single-cell microalga. The NF is a mixture of triglycerides in which docosahexaenoic acid (DHA) represents 38%-44% of fatty acids. The applicant proposed to use the NF in infant formulae (IF) and follow-on formulae (FOF). The use levels proposed by the applicant were derived from Regulation (EU) 2016/127, which states the mandatory addition of DHA to IF and FOF at the level of 20-50 mg/100 kcal. The evidence provided demonstrated that the strain S. sp. CABIO-A-2 is phylogenetically closely related to the strain S. sp. ATCC 20888. The assessment of some already authorised S. sp. oils in the Union list were also based on similarities with the strain ATCC 20888. The applicant provided a 90-day repeated dose toxicity study in rats with the NF. No adverse effects were observed up to the highest dose tested, i.e. 10.2 g/kg body weight (bw) per day. Taking into account the toxicity studies performed with the NF and with DHA-oils derived from strains belonging to the genus Schizochytrium, its phylogenetical profile, the production process, the composition of the NF and the absence of marine biotoxins and viable cells in the NF, the Panel considers that there are no concerns with regard to the toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use.

Early Introduction of Novel and Less-Studied Food Allergens in the Plant-Based Era: Considerations for US and EU Infant Formula Regulations

Early life feeding practices may affect the long-term health of individuals, particularly in terms of the development of non-communicable diseases, such as metabolic and allergic diseases. Accumulating evidence suggests that the interplay of breastfeeding and/or formula feeding followed by the introduction of solids plays a role in the occurrence of non-communicable diseases both in the short and long term. International food allergy guidelines recommend that breastfeeding women do not need to avoid food allergens and do not recommend any infant formula for allergy prevention. Guidelines regarding solid food introduction for food allergy prevention recommend the introduction of well-cooked eggs and peanuts around 4–6 months of age, and not to delay the introduction of other food allergens. There is also an increasing trend to feed infants a plant-based or plant-forward diet and have access to infant formulas based on plant-based ingredients. The use of novel plant-based infant formulas raises a few questions reviewed in this paper: (1) Do fortified, plant-based infant formulas, compliant with US Food and Drug Administration (FDA) regulations and European Food Safety Authority (EFSA) (European) guidelines, support adequate infant growth? (2) Are plant-based infant formulas suitable for the management of cow’s milk allergy? (3) Does feeding with novel, plant-based infant formulas increase the risk of food allergies to the food allergens they contain? (4) Does feeding infants plant-based food allergens in early life increase the risk of allergic and severe allergic reactions? The review of the literature indicated that (1) plant-based formulas supplemented with amino acids and micronutrients to comply with FDA regulations and EFSA guidelines, evaluated in sufficiently powered growth studies, can support adequate growth in infants; (2) currently available plant-based infant formulas are suitable for the management of CMA; (3) an early introduction and continuous intake of food allergens are more likely to prevent food allergies than to increase their risk; and (4) an early introduction of food allergens in young infants is safe.