Foods for infants and other groups
Foods for specific groups are designed to fulfil the nutritional requirements of vulnerable population Community of humans, animals or plants from the same species groups. In the EU, foods for specific groups (FSG) include:
- Foods intended for infants (children under the age of 12 months) and young children (aged between one and three years), including:
- Infant and follow-on formulae;
- Processed cereal-based foods: simple cereals, cereals with an added high protein A type of molecule composed of complex strings of amino acids (protein building blocks) food, pastas, rusks and biscuits;
- Baby foods.
- Foods for special medical purposes.
- Total diet replacement for weight control.
Latest
February 2024 – our nutrition experts are updating EFSA’s Guidance on the scientific principles and data required to assess the safety and relative bioavailability A term to describe how much of a substance gets into the blood through a variety of routes, including the diet. It may refer to vitamins, additives, pesticides or medicines of new substances proposed as sources of micronutrients for use in food supplements, fortified foods and foods for specific groups (for infants and young children, for medical purposes, and total diet replacements for weight control).
A draft of the updated Guidance is now available for feedback - if you are a nutrition expert, scientist or have scientific information to share, we want to hear from you during our public consultation!
Guidance documents are used by applicants when submitting scientific information in applications for market authorisation and by risk assessors during the evaluation process. We regularly update these documents to take account of the latest science and recent experience in the evaluation of applications. In addition, the European Commission asked EFSA to cover two new areas in the guidance document:
- new forms of micronutrients (e.g. micronutrient metabolites, new molecules having vitamin Dietary substance needed in very small amounts to support normal growth and maintenance of health in humans and animals. Most vitamins are 'essential' as they are not made within the body activity), many of which are novel foods; and
- quantification of the relative bioavailability of the micronutrient from the new source to derive of a conversion factor for labelling purposes.
Send us your feedback by 14 April!
Milestones
2021
EFSA publishes a statement on additional scientific evidence in relation to the essential composition of total diet replacement for weight control.
2020
A special virtual issue of the EFSA Journal contains our scientific advice on infant and young child (‘toddler’) nutrition, covering topics such as the safety assessment of infant formulas, the appropriate age to introduce complementary feeding The period when complementary foods are given to an infant together with either breast milk or formula or both, and substances that may be added to or may be unintendedly present in foods consumed by infants.
2019
EFSA updates its scientific advice on the appropriate age range for the introduction of complementary foods to infants.
2017
August
EFSA publishes a protocol for a systematic review on health outcomes related to the age of introduction of complementary food into an infant’s diet.
May
EFSA publishes a scientific opinion Opinions include risk assessments on general scientific issues, evaluations of an application for the authorisation of a product, substance or claim, or an evaluation of a risk assessment on the safety and suitability for use by infants of follow-on formulae with a protein content of at least 1.6 g/100 kcal.
Guidance is published on preparing applications for infant and/or follow-on formulae manufactured from protein hydrolysates.
2015
Guidance is published on preparing applications for foods for special medical purposes.
2014
EFSA publishes a scientific opinion on the essential composition of infant and follow-on formulae.
2009
EFSA publishes a scientific opinion on the appropriate age for the introduction of complementary foods to infants.
EFSA's role
EFSA provides scientific advice to support risk managers and decision-makers in the European Commission, Parliament and Members States, particularly in the areas below.
Infant and follow-on formulae
We evaluate on a case-by-case basis the safety and suitability of infant or follow-on formulae that differ in composition from that specified in EU regulations, including when manufactured from protein hydrolysates. The European Commission and Member States consider this advice when deciding whether to authorise a requested modification. We carry out our assessment based on applications provided by food operators who should use our scientific and technical guidance document when preparing their dossiers.
Foods for special medical purposes (FSMPs)
The European Commission may ask EFSA to evaluate the composition and proposed uses of a FSMP, to support them decide whether that food should be classified as FSMP. In this context, we published a scientific and technical guidance document to assist in the preparation and presentation of FSMP dossiers.
Scientific nutrition advice
Some of our scientific nutrition advice regarding food for infants (<1 year) and young children (1-3 years) is described in the topic on DRVs and a special edition of the EFSA Journal, the Summary report on dietary reference values for nutrients, the update of the tolerable upper intake level (UL) for vitamin D for infants, and the Overview on tolerable upper intake levels as derived by the Scientific Committee on Food (SCF) and the EFSA NDA Panel.
Scientific advice on other substances in foods for infants
In some other areas of EFSA’s work, we sometimes receive requests for scientific advice in relation to foods for infants or other groups. For example, in May 2018, we published a scientific opinion on pesticides in foods for infants and young children. In April 2017, our Scientific Committee adopted a guidance on risk assessment of substances present in food intended for infants below 16 weeks of age, focusing on an age for which health-based guidance values (i.e. ‘safe levels’) were traditionally not considered applicable. This work helps our expert Panel on Food Additives and Flavourings to carry out evaluations in accordance with EFSA’s Guidance on food additives evaluation published in 2012.
Food consumption by infants in Europe
To support EFSA in delivering its scientific advice, the EFSA Comprehensive European Food Consumption Database contains data on food consumption habits and patterns across the EU, in particular from surveys covering infants and young children. A new release of the database was published in April 2018, which for the first time includes data collected under EFSA’s EU Menu project
EU framework
Regulation EU 609/2013 on Foods for Specific Groups (FSG) covers the following food categories, for which delegated acts provide specific composition and labelling rules that will progressively replace the previous legal framework:
- Infant and follow-on formulae – Regulation EU 2016/127 applies to these formulae from 2020, except for those manufactured from protein hydrolysates, for which the provisions will be applicable from 2021.
- Processed cereal-based foods and other baby foods – regulation pending.
- Foods for special medical purposes – Regulation EU 2016/128 applies from 2019.
- Total diet replacement for weight control – Regulation EU 2017/1798 applies from 2022.
The annex of the FSG Regulation establishes the list of substances that can be added to one or more of these food categories. This list will apply when the corresponding acts listed above become applicable.
The labelling, presentation and advertising of foods for specific groups should provide information on their appropriate use. In this context, EFSA updated its scientific advice on the appropriate age of introduction of complementary feeding into an infant’s diet.
The FSG Regulation does not cover foods intended for sportspeople and young-child formulae, meal replacements for weight control, gluten protein found in wheat, barley and rye. The symptoms of coeliac disease are triggered by the ingestion of gluten-free or very-low gluten foods, foods without lactose or with a reduced content of lactose.
The regulation specifies that:
- Regulation EU 1169/2011 covers the use of ‘gluten-free’ and ‘very low gluten’ foods, and Regulation EU 828/2014 the related information to consumers.
- The use of statements on meal replacement products is covered by Regulation EC 1924/2006 on nutrition and health claims made on foods, and Regulation EU 2016/1413.
- Regulation EU 1169/2011 defines the use of statements indicating the absence or reduced presence of lactose in food, taking into account EFSA’s scientific advice on lactose thresholds in lactose intolerance and galactosaemia.
More information on EU legislation on foods for specific groups and rules that apply in the transition phase is available from the European Commission website.
Other legal frameworks
Some novel foods may be used in foods for specific groups, after an authorisation process that includes a scientific evaluation by EFSA. An implementing regulation provides the list of novel foods authorised for the EU market, including their conditions of use.
EFSA provides scientific advice for the evaluation of the safety and bioavailability of new sources of nutrients in foods. The principle behind such evaluations is described in the EFSA topic on food supplements.
Foods for specific groups may contain additives at maximum levels specified in Annex II and III of Regulation EC 1333/2008 on food additives, on which EFSA provides scientific advice.
FAQ
Infants are children under the age of 12 months.
- Infant formula is defined as a ‘food intended for use by infants during the first months of life and satisfying by itself the nutritional requirements of such infants until the introduction of appropriate complementary feeding’.
- Follow-on formula is defined as a ‘food intended for use by infants when appropriate complementary feeding is introduced and which constitutes the principal liquid element in a progressively diversified diet of such infants’.
Foods intended for infants (<12 months) and young children (1-3 years old) may be infant and follow-on formula, processed cereal-based foods and baby foods.
Processed cereal-based foods and baby foods are both ‘intended to fulfil the particular requirements of infants in good health while they are being weaned and of young children in good health as a supplement to their diet and/or for their progressive adaptation to ordinary food’.
Processed cereal-based foods is an umbrella term for the following categories:
- Simple cereals which are or have to be reconstituted with milk or other appropriate nutritious liquids.
- Cereals with an added high protein food which are or have to be reconstituted with water or other protein-free liquid.
- Pastas which are to be used after cooking in boiling water or other appropriate liquids.
- Rusks and biscuits which are to be used either directly or, after pulverisation, with the addition of water, milk or other suitable liquids.
The category ‘baby food’ excludes processed cereal-based foods and milk-based drinks and similar products intended for young children.
For more information see the EU framework section of the European Commission.
Consumers of foods for special medical purposes (FSMPs) have different nutritional needs to the general healthy population. An FSMP is specially processed or formulated and intended for the dietary management of patients, and to be used under medical supervision.
An FSMP ‘is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone’.
For more information see our FAQ on foods for special medical purposes and the EU framework section of the European Commission.
Total diet replacement for weight control is defined as a ‘food specially formulated for use in energy restricted diets for weight reduction which, when used as instructed by the food business operator, replaces the whole daily diet’.
For more information see the EU framework section of the European Commission.
The European Commission has published comprehensive information on the objectives and scope of the regulation on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control (FSG Regulation), as well as the many issues surrounding the transition between the previous and the new legal frameworks.