Food for infants and young children

To ensure appropriate nutritional composition and safety of foods specifically manufactured for infants and young children, as well as appropriate consumer information, the Commission has defined specific rules for such foodstuffs.

The rules concern infant and follow-on formulae, processed-cereal based foods and baby foods.

Glossary

Infants	Children under the age of 12 months
Young children	Children aged between 1 and 3 years
Infant formulae	Food used by infants during the first months of life and satisfying by themselves the nutritional requirements of such infants until the introduction of appropriate complementary feeding
Follow-on formulae	Food used by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants
Processed cereal baby-food and baby foods	Food intended for use by infants when they are weaned and by young children as a supplement to their diet and/or for their progressive adaptation to ordinary food

Formulae

Infant formulae and follow-on formulae are products designed to satisfy the specific nutritional requirements of healthy infants (children under the age of 12 months).

These products were specifically covered by Commission Directive 2006/141/EC, adopted under the old legislative framework of Directive 2009/39/EC and subsequently amended on several occasions.

The Directive laid down the requirements for the composition and labelling of infant formulae and follow-on formulae.

The annexes of the Directive give criteria for the composition (energy, protein, carbohydrate, fat, mineral substances, vitamins and certain other ingredients) of infant formulae and follow-on formulae including, where necessary, minimum and maximum levels.

Directive 2006/141/EC also encompassed the specific rules on the presence of pesticides residues in infant and follow-on formulae, previously set out in Commission Directive 1999/50/EC. It required that infant formula and follow-on formula contain no detectable levels of pesticide residues, meaning not more than 0.01 milligrams of pesticide residues per kilogram.

The Directive also prohibits the use of certain very toxic pesticides in the production of infant and follow-on formulae and establishes levels lower than the general maximum level of 0.01 milligrams per kilogram for a few other very toxic pesticides.

What has the new Regulation on Food for Specific Groups done?

For infant formulae and follow-on formulae from 20 July 2016?

The Regulation:

Set general compositional and labelling rules. In addition, it extends to the labelling of follow-on formula the restriction of use of pictures or text which may idealise the use of products (previously only applicable to infant formula)
Required the Commission to adopt, through delegated act, specific compositional and information rules for infant and follow-on formulae, which replaced Directive 2006/141/EC. Commission delegated Regulation (EU) 2016/127 was adopted on 25 September 2015 and started to apply on 22 February 2020, except in respect of infant formula and follow-on formula manufactured from protein hydrolysates, to which it will apply from 22 February 2022. Until that date, the relevant rules of Directive 2006/141/EC remain applicable. The new delegated Regulation:
- Updates the existing compositional requirements on the basis of the latest scientific advice
- Modifies the rules on labelling to ensure consistency with horizontal rules of Regulation (EU) No 1169/2011 on the provision of food information to consumers, taking into account the specificities of the products
- Forbids the use of nutrition and health claims on infant formula to protect breast-feeding
- Facilitates the monitoring activities of national competent authorities by requiring operators to notify them of the placing on the market of many follow-on formulae (in addition to infant formulae, for which the obligation already existed).

In addition to the requirements in Regulation (EU) 2016/127, infant formulae and follow-on formulae must also comply with other specific provisions laid down in the relevant measures of EU law on hygiene, on the use of food additives, on the presence of contaminants and on the use of materials intended to come into contact with the products.

Submission of dossiers on infant and/or follow-on formula manufactured from protein hydrolysates

From 22 February 2022, infant formula and follow-on formula manufactured from protein hydrolysates will have to comply with the new requirements of delegated Regulation (EU) 2016/127.

As explained in the delegated Regulation's recitals, these requirements may be updated in the future in order to allow the placing on the market of formulae manufactured from protein hydrolysates with different compositions following a case-by-case evaluation of their safety and suitability by the European Food Safety Authority.

In addition, after the assessment by the Authority, on the basis of studies, where it is demonstrated that a specific formula manufactured from protein hydrolysates reduces the risk of developing allergy to milk proteins, further consideration will be given to how to adequately inform parents and caregivers about that property of the product.

Food business operators should submit dossier for evaluation of an infant and/or follow-on formula manufactured from protein hydrolysates via the E-submission Food Chain Platform.

Scientific advice on the composition of infant formulae and follow-on formulae

Scientific and technical guidance for the preparation and presentation of a dossier for evaluation of an infant and/or follow-on formula manufactured from protein hydrolysates (Revision 1)1
Scientific opinion on the update of the tolerable upper intake level for vitamin D for infants
Scientific Opinion on the essential composition of infant and follow-on formulae (2014)
Scientific Opinion on the suitability of goat milk protein as a source of protein in infant formulae and in follow-on formulae (2012)
Scientific Opinion related to the safety and suitability for particular nutritional use by infants of formulae based on whey protein partial hydrolysates with a protein content of at least 1.9 g protein/100 kcal (2005)
Scientific Opinion related to the safety and suitability for particular nutritional use by infants of fructooligosaccharides in infant formulae and follow-on formulae (2004)
Scientific Opinion related to the evaluation of goats' milk protein as a protein source for infant formulae and follow-on formulae (2004)
Statement replying to applicant's comment on the Panel's Opinion relating to the evaluation of goat's milk protein as a protein source for infant formulae and follow-on formulae (2005)
Report on the revision of essential requirements of infant formulae and follow-on formulae (2003)
Statement on the use of resistant short chain carbohydrates (oligofructose and oligogalactose) in infant formulae and in follow-on formulae (2001)
Additional statement on the use of resistant short chain carbohydrates (oligofructosyl-saccharose and oligogalactosyl-lactose) in infant formulae and in follow-on formulae (2001)
Scientific Opinion on the calculation of vitamin E content of infant formulae and follow-on formulae (1996)
Scientific Opinion on phthalates in infant formulae (1996)
Report on essential requirements for infant formulae and follow-on formulae (1993)
Report on infant formulae claimed to be 'hypoallergenic' or 'hypoantigenic' (1991)
Report on the minimum requirements for soya-based infant formulae and follow-up milks (1988)
First report on the essential requirements of infant formulae and follow-up milks based on cows' milk proteins (1983)
First Addendum to the Report concerning the essential requirements of infant formulae and follow-up milks based on cows' milk (1989)
First Addendum to the Report concerning the minimum requirements for soya-based infant formulae and follow-up milks (1989)
Second Addendum concerning the essential requirements of infant formulae and follow-up milks based on cows' milk proteins and the minimal requirements for soya-based infant formulae and follow-up milks (1991)

Additional Scientific Advice

Scientific Opinion on a maximum residue limit (MRL) of 0.01 mg/kg for pesticides in foods intended for infants and young children (1997)
Further advice on the Scientific Opinion on a maximum residue limit (MRL) of 0.01 mg/Kg for pesticides in foods intended for infants and young children (1998)
Scientific Opinion on lindane in foods intended for infants and young children (1998) (currently unavailable)
Scientific Opinion on lindane in baby foods (1994)

Cereals and other baby foods

Processed cereal-based foods and other baby foods (weaning foods) are specifically intended for infants (children under the age of 12 months) and young children (between one and three years) as they progress onto a mixed family diet.

Processed cereal-based foods and baby foods for infants and young children are currently covered by Commission Directive 2006/125/EC, adopted under the old legislative framework of Directive 2009/39/EC.

It sets out rules on the composition and labelling of processed-cereal based foods and other baby foods. It gives criteria for the composition (protein, carbohydrate, fat, mineral substances and vitamins) of weaning foods including, where necessary, minimum and maximum levels.

The Directive encompasses the specific rules on the presence of pesticides residues in processed cereal-based baby foods and baby foods set out in Commission Directive 99/39/EC and requires that this type of food contains no detectable levels of pesticide residues, meaning not more than 0.01 milligrams of pesticide residues per kilogram.

In addition, the Directive prohibits the use of certain very toxic pesticides in the production of processed cereal-based baby foods and baby foods and establishes levels lower than the general maximum level of 0,01 milligrams per kilogram for a few other very toxic pesticides.

In addition to the requirements in Directive 2006/125/EC, processed cereal-based foods and baby foods must also comply with other specific provisions laid down in the relevant measures of EU law on hygiene, on the use of food additives, on the presence of contaminants and on the use of materials intended to come into contact with the products.

What has the new Regulation on Food for Specific Groups done?

For processed cereal-based foods and other baby foods from 20 July 2016?

The Regulation:

Set general compositional and labelling rules
Required the Commission to adopt, through delegated act, specific compositional and labelling rules for processed cereal-based foods and baby foods, which will replace Directive 2006/125/EC. Until the finalisation of the delegated act, the rules of Directive 2006/125/EC remain applicable.

Scientific advice on the composition of processed cereal-based foods and baby foods

Scientific Opinion on maximum limits for vitamins and minerals in processed cereal-based foods and baby foods (1996)
First report concerning the essential requirements for weaning foods (1990)
Scientific opinion on the appropriate age range for introduction of complementary feeding into an infant's diet
Scientific opinion on calcium l‐methylfolate as a source of folate added for nutritional purposes to infant and follow‐on formula, baby food and processed cereal‐based food

Additional scientific advice on pesticide residues in foods for infants and young children

Scientific Opinion on a maximum residue limit (MRL) of 0.01 mg/kg for pesticides in foods intended for infants and young children (1997)
Further advice on the Scientific Opinion expressed on the 19 September 1997 on a maximum residue limit (MRL) of 0.01 mg/Kg for pesticides in foods intended for infants and young children (1998)
Scientific Opinion on lindane in foods intended for infants and young children (1998)
Scientific Opinion on lindane in baby foods (1994)

Food for infants and young children