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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.

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.

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.

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 provide scientific and technical guidance for the preparation and presentation of applications for authorisation of infant and/or follow-on formula manufactured from protein hydrolysates. This guidance document addresses the information and data to be submitted to EFSA on infant and follow-on formulae manufactured from protein hydrolysates with respect to the safety and suitability of the specific formula and/or the formula's efficacy in reducing the risk of developing allergy to milk proteins. The guidance will be further reviewed and updated with the experience gained from the evaluation of specific applications for authorisation, and in the light of future Community guidelines and legislation. 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, EFSA was asked to provide scientific and technical guidance for the preparation and presentation of a dossierfor evaluation of an infant and/or follow-on formula manufactured from protein hydrolysates. This guidance document addresses the information and data to be submitted to EFSA on infant and follow-on formulae manufactured from protein hydrolysates with respect to the nutritional safety and suitability of the specific formula and/or the formula's efficacy in reducing the risk of developing allergy to milk proteins. The guidance will be further reviewed and updated with the experience gained from the evaluation of specific dossiers, and in the light of applicable Union guidelines and legislation. The guidance was adopted by the Panel on Dietetic Products, Nutrition and Allergies on 5 April 2017.Upon request from the European Commission in 2020, it has been revised to inform food business operators of the new provisions in the pre-submission phase and in the procedure set out in the General Food Law, as amended by the Transparency Regulation. This revised guidance applies to all dossiers submitted as of 27 March 2021 and shall be consulted for the preparation of dossiers intended to be submitted from that date onwards. For dossiers submitted prior to 27 March 2021, the previous guidance, published in May 2017 remains applicable.

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide scientific and technical guidance for the preparation and presentation of applications for authorisation of infant and/or follow‐on formula manufactured from protein hydrolysates. This guidance document addresses the information and data to be submitted to EFSA on infant and follow‐on formulae manufactured from protein hydrolysates with respect to the safety and suitability of the specific formula and/or the formula's efficacy in reducing the risk of developing allergy to milk proteins. The guidance will be further reviewed and updated with the experience gained from the evaluation of specific applications for authorisation, and in the light of future Community guidelines and legislation. 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 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.