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Complementary food is needed when breast milk (or infant formula) alone is no longer sufficient for both nutritional and developmental reasons. The timing of its introduction, therefore, is an individual decision, although 6 months of exclusive breastfeeding can be recommended for most healthy term infants. The new foods are intended to 'complement' ongoing breastfeeding with those dietary items whose intake has become marginal or insufficient. Both breastfeeding and complementary feeding can have direct or later consequences on health. The evaluation of consequences of both early and late introduction of complementary food can neither disregard the effect of breastfeeding compared to formula feeding nor the composition or quality of the complementary food. Possible short-term health effects concern growth velocity and infections, and possible long-term effects may relate to atopic diseases, type 1 and 2 diabetes, obesity and neuromuscular development. On the basis of the currently available evidence, it is impossible to exactly determine the age when risks related to the start of complementary feeding are lowest or highest for most of these effects, with the possible exception of infections and early growth velocity. The present knowledge on undesirable health effects, however, is mainly based on observational studies, and although some mechanisms have been proposed, further prospective studies have to clarify these unsolved issues. Even less evidence on the consequences of the timing of complementary food introduction is available for formula-fed infants. Copyright © 2012 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Data from Berlin (Germany) show a significant correlation between the increase in the stork population around the city and the increase in deliveries outside city hospitals (out-of-hospital deliveries). However, there is no correlation between deliveries in hospital buildings (clinical deliveries) and the stork population. The decline in the number of pairs of storks in the German state of Lower Saxony between 1970 and 1985 correlated with the decrease of deliveries in that area. The nearly constant number of deliveries from 1985 to 1995 was associated with an unchanged stork population (no statistical significance). However, the relevance of the stork for the birth rate in that part of Germany remains unclear, because the number of out-of-hospital deliveries in this area is not well documented. A lack of statistical information on out-of-hospital deliveries in general is a severe handicap for further proof for the Theory of the Stork. The intended value (disclaimer): This article is not intended to disprove the value of serious epidemiological investigations. It is an example of how studies based on popular belief and unsubstantiated theory, seconded by low quality references and supported by coincidental statistical association could lead to apparent scientific endorsement. Insofar it is a humorous case study for education in perinatal epidemiology. [ABSTRACT FROM AUTHOR]

Abstract: The identification and characterization of benefits as a consequence of consumption of food, food constituents or nutrients used to be neglected in comparison to the assessment of risks because the safety of food had priority. Interest in benefit assessment is the consequence of the realisation that both adverse and positive effects on health can follow the consumption of the same food or food constituent and that a balance between the two should be the aim. Moreover, proven benefits in connection with food are the basis of health related claims on food labels. Benefit assessment should follow a procedure which is parallel to structured risk assessment and apply the same stringent criteria with respect to substantiation. Benefits will consist of either the reduction of the probability of adverse health effects or the increase of the probability of positive health effects. [Copyright &y& Elsevier]

The article presents a study that investigates the effectiveness of short verbal stress rating (VRSS) scale in measuring stress level of children in Sweden. The different methods of measuring children's stress and the experiment done on children to evaluate their stress level are mentioned. Moreover, results of the study show that VRSS are effective and valid.

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. [ABSTRACT FROM AUTHOR]

Abstract Dietary treatment of phenylketonuria is well established to be safe and to prevent developmental and mental impairment in patients with low or absent phenylalanine hydroxylase activity. The use of semi-synthetic diets necessitates careful and longitudinal control not only of physical and intellectual development, which are both near normal in well treated patients, but also of potential diet inherent insufficiencies of essential nutrients. Concern has been raised by some reports on growth retardation in young patients on strict diets and on decreased bone density in older phenylketonuric children. The clinical significance of these findings is not known. [ABSTRACT FROM AUTHOR]

The European Commission asked EFSA to deliver an opinion on the nutritional safety and suitability of a specific protein hydrolysate. It is derived from whey protein concentrate and used in infant and follow‐on formula by HIPP‐Werk Georg Hipp OHG. The dossier that was submitted to the European Commission aimed at requesting an amendment of Regulation (EU) 2016/127 with respect to the protein sources that may be used in infant and/or follow‐on formula. This opinion does not cover the assessment of the safety of the food enzymes used in the manufacture of the protein hydrolysate. 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 1.9 g/100 kcal and consumed as the sole source of nutrition by infants for 3 months led to growth equivalent to a formula manufactured from intact cow's milk protein with the same protein content. No experimental data have been provided on the nutritional safety and suitability of this protein source in follow‐on formula. However, given that it is consumed with complementary foods and the protein source is considered 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 1.9 g/100 kcal protein and complies with the compositional criteria of Commission Delegated Regulation (EU) 2016/127 and the amino acid pattern in its Annex IIIA. [ABSTRACT FROM AUTHOR]

The European Commission asked EFSA to deliver an opinion on the nutritional safety and suitability of a specific protein hydrolysate. It is derived from whey protein concentrate and used in an infant and follow‐on formula by Danone Trading ELN 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. This opinion does not cover the assessment of the safety of the food enzymes used in the manufacture of the protein hydrolysate. 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 2.3 g/100 kcal and consumed as the sole source of nutrition by infants for 3.5 months led to growth equivalent to a formula manufactured from intact cow's milk protein (2 g protein/100 kcal). No experimental data have been provided on the nutritional safety and suitability of this protein source in follow‐on formula. However, given that it is consumed with complementary foods and the protein source is considered 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 2.3 g/100 kcal protein and complies with the compositional criteria of Commission Delegated Regulation (EU) 2016/127 and the amino acid pattern in its Annex IIIA. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) derived dietary reference values (DRVs) for sodium. Evidence from balance studies on sodium and on the relationship between sodium intake and health outcomes, in particular cardiovascular disease (CVD)-related endpoints and bone health, was reviewed. The data were not sufficient to enable an average requirement (AR) or population reference intake (PRI) to be derived. However, by integrating the available evidence and associated uncertainties, the Panel considers that a sodium intake of 2.0 g/day represents a level of sodium for which there is sufficient confidence in a reduced risk of CVD in the general adult population. In addition, a sodium intake of 2.0 g/day is likely to allow most of the general adult population to maintain sodium balance. Therefore, the Panel considers that 2.0 g sodium/day is a safe and adequate intake for the general EU population of adults. The same value applies to pregnant and lactating women. Sodium intakes that are considered safe and adequate for children are extrapolated from the value for adults, adjusting for their respective energy requirement and including a growth factor, and are as follows: 1.1 g/day for children aged 1-3 years, 1.3 g/day for children aged 4-6 years, 1.7 g/day for children aged 7-10 years and 2.0 g/day for children aged 11-17 years, respectively. For infants aged 7-11 months, an Adequate Intake (AI) of 0.2 g/day is proposed based on upwards extrapolation of the estimated sodium intake in exclusively breast-fed infants aged 0-6 months. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Nutrition, Novel Foods and Food Allergens (NDA) revised its 2009 Opinion on the appropriate age for introduction of complementary feeding of infants. This age has been evaluated considering the effects on health outcomes, nutritional aspects and infant development, and depends on the individual's characteristics and development. As long as foods have an age-appropriate texture, are nutritionally appropriate and prepared following good hygiene practices, there is no convincing evidence that at any age investigated in the included studies (< 1 to < 6 months), the introduction of complementary foods (CFs) is associated with adverse health effects or benefits (except for infants at risk of iron depletion). For nutritional reasons, the majority of infants need CFs from around 6 months of age. Infants at risk of iron depletion (exclusively breastfed infants born to mothers with low iron status, or with early umbilical cord clamping (< 1 min after birth), or born preterm, or born small-for-gestational age or with high growth velocity) may benefit from earlier introduction of CFs that are a source of iron. The earliest developmental skills relevant for consuming pureed CFs can be observed between 3 and 4 months of age. Skills for consuming finger foods can be observed in some infants at 4 months, but more commonly at 5-7 months. The fact that an infant may be ready from a neurodevelopmental perspective to progress to a more diversified diet before 6 months of age does not imply that there is a need to introduce CFs. There is no reason to postpone the introduction of potentially allergenic foods (egg, cereals, fish and peanut) to a later age than that of other CFs as far as the risk of developing atopic diseases is concerned. Regarding the risk of coeliac disease, gluten can be introduced with other CFs. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) has derived dietary reference values (DRVs) for chloride. There are no appropriate biomarkers of chloride status, no balance studies and no adequate evidence on the relationship between chloride intake and health outcomes that can be used to set DRVs for chloride. There is a close relationship between sodium and chloride balances in the body. Sodium chloride is the main source of both electrolytes in European diets and similar urinary excretion levels of sodium and chloride (on a molar basis) are typically observed in Western populations. Hence, the Panel considered that reference values for chloride can be set at values equimolar to the reference values for sodium for all population groups, and are as follows: 1.7 g/day for children aged 1-3 years, 2.0 g/day for children aged 4-6 years, 2.6 g/day for children aged 7-10 years, 3.1 g/day for children aged 11-17 years and 3.1 g/day for adults including pregnant and lactating women. Consistent with the reference values for sodium, these levels of chloride intake are considered to be safe and adequate for the general EU population, under the consideration that the main dietary source of chloride intake is sodium chloride. For infants aged 7-11 months, an adequate intake of 0.3 g/day is set. [ABSTRACT FROM AUTHOR]

Abstract: BRAFO, Benefit-Risk Analysis for Foods, was a European Commission project funded within Framework Six as a Specific Support Action and coordinated by ILSI Europe. BRAFO developed a tiered methodology for assessing the benefits and risks of foods and food components, utilising a quantitative, common scale for health assessment in higher tiers. This manuscript reports on the implications of the experience gained during the development of the project for the further improvement of benefit–risk assessment methodology. It was concluded that the methodology proposed is applicable to a range of situations and that it does help in optimising resource utilisation through early identification of those benefit–risk questions where benefit clearly outweighs risk or vice versa. However, higher tier assessments are complex and demanding of time and resources, emphasising the need for prioritisation. Areas identified as requiring further development to improve the utility of benefit–risk assessment include health weights for different populations and endpoints where they do not currently exist, extrapolation of effects from studies in animals to humans, use of in vitro data in benefit–risk assessments, and biomarkers of early effect and how these would be used in a quantitative assessment. [Copyright &y& Elsevier]

Within the group of botanical products there is a large range of variation with regard to their properties. Some products are identical to foods while others come close to or are medicines. Botanical products are regulated differently within the different member states of the European Union (EU) and globally. They are regulated either as food or as medicinal products, and in the latter case often with simplified registration procedures. These differences are caused by differences in traditional use, in cultural and historical background, in scientific substantiation and in enforcement of current legislation. One may expect that in the future differences will remain, unless EU legislation is enacted with sufficient room for different approaches. The strengths and weaknesses of the different regulatory procedures have been reviewed and evaluated as well as the current methods for quality, efficacy and safety evaluation. Criteria to categorize botanical products have been defined, such that botanical products can be regulated under the current food and medicinal regulations. Furthermore, a decision tree has been developed as a tool to distinguish herbal medicinal products from botanical health products and vice versa, and to provide a stepwise framework for the assessment of safety and efficacy. [Copyright &y& Elsevier]

Food authorities should base their decisions on both risk assessment and benefit assessment in relation to foods, food constituents or nutrients when risk–benefit assessment can be carried out. Benefit assessment should mirror the well-established steps of risk assessment. However, methods for their comparison, weighing risks against benefits, have as yet to be developed. The general framework currently available in risk–benefit health assessment of food is described and illustrated with two examples: food fortification with vitamins and minerals, and the consumption of vegetables in relation to their nitrate content. [Copyright &y& Elsevier]