REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on young child formulae
Date: 2016-03-31
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Food Safety Authority, baby food, consumer protection, dietary product, early childhood, food safety, foodstuffs legislation, human nutrition, labelling, launching of a product

EUROPEAN 
COMMISSION 

Brussels, 31.3.2016  
COM(2016) 169 final 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

on young child formulae 

{SWD(2016) 99 final} 

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TABLE OF CONTENTS 

INTRODUCTION....................................................................................... 3 

THE MARKET OF YOUNG-CHILD FORMULAE IN THE EU............. 3 

Products' presence and composition............................................................ 3 
Market size and value, prices and structure of the market .......................... 4 
The marketing of young-child formulae ..................................................... 5 

CONSUMERS' PERCEPTION AND BEHAVIOUR ................................ 5 

THE  LEGAL  FRAMEWORK  APPLICABLE  TO  YOUNG-CHILD 
FORMULAE............................................................................................... 6 

EFSA'S SCIENTIFIC ADVICE ON YOUNG-CHILD FORMULAE....... 8 

SUMMARY  OF  THE  ISSUES  RELATED  TO  YOUNG-CHILD 
FORMULAE............................................................................................... 8 

SUMMARY OF MEMBER STATES' AND INTERESTED PARTIES' 
POSITIONS .............................................................................................. 10 

CONCLUSIONS....................................................................................... 10 

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REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

on young-child formulae 

1. 

INTRODUCTION 

This report meets the obligation set for the Commission by Article 12 of Regulation 
(EU) No 609/2013 of the European Parliament and of the Council on food intended 
for  infants  and  young  children,  food  for  special  medical  purposes,  and  total  diet 
replacement for weight control ("Regulation on Food for Specific Groups", or "FSG 
Regulation")1.  

Article 12 requires the Commission to present to the European Parliament and to the 
Council,  after  consulting  the  European  Food  Safety  Authority  (EFSA),  a  report  on 
the necessity, if any, of special provisions for milk-based drinks and similar products 
intended for young children. 
This report builds upon two Scientific Opinions of EFSA2, a market study carried out 
for  EFSA3  and  extensive  consultation  with  national  competent  authorities  and 
interested parties. It is accompanied by a Staff Working Document (SWD) with more 
detailed information on its findings.  

2. 

2.1 

THE MARKET OF YOUNG-CHILD FORMULAE

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 IN THE EU 

Products' presence and composition  

Young-child  formulae  are  not  defined  in  EU  legislation.  They  can  be  described  as 
specifically  processed/formulated  protein-based  drinks  intended  to  satisfy  the 
nutritional  requirements  of  young  children  aged  1-3  years5.  While  the  number  of 
manufacturers  is  small,  there  are  hundreds  of  young-child  formulae  present  on  the 
EU market. The number of products per Member State can vary significantly.  

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Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food 
intended for infants and young children, food for special medical purposes, and total diet replacement 
for  weight  control  and  repealing  Council  Directive  92/52/EEC,  Commission  Directives  96/8/EC, 
1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and 
of  the  Council  and  Commission  Regulations  (EC)  No  41/2009  and  (EC)  No  953/2009  (OJ  L  181, 
29.6.2013, p. 35). 
EFSA  Panel  on  Dietetic  Products,  Nutrition  and  Allergies,  2013,  Scientific  Opinion  on  nutrient 
requirements and dietary intakes of infants and young children in the European Union, EFSA Journal 
2013;11(10):3408; EFSA Panel on Dietetic Products, Nutrition and Allergies, 2014, Scientific Opinion 
on the essential composition of infant and follow-on formulae. EFSA Journal 2014;12(7):3760. 
AINIA,  Centro  Tecnológico,  2013,  Report  of  “data  collection  with  respect  to  the  availability  and 
nutritional composition of different types of milk-based drinks and similar products for young children 
with  the  denomination  of  “growing  up  milks”  or  “toddlers'  milks”  or  with  similar  terminology 
currently on the market in EU Member States”, EFSA supporting publication 2013:EN-505. 
The denomination "young-child formulae" will be hereinafter used to refer to the products subject of 
the  report  (in  line  with  the  way  EFSA  referred  to  these  products  in  its  Scientific  Opinions  on  the 
matter).  
For  the  purposes  of  this  report,  the  concept  of  "young-child  formulae"  does  not  include  "fortified 
milks",  namely  milks  fortified  in  different  nutrients  (e.g.  vitamins  or  minerals)  and  marketed  to  the 
general  population  or  sub-groups  thereof  (e.g.  children  in  general),  but  not  exclusively  to  young 
children aged 1-3 years. 

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The  energy  content  and  composition  of  young-child  formulae  is  varied6.  In  most 
cases, cow's milk is used as a source of protein7 but the product's protein content is 
normally lower than in cow's milk and, in most cases, within the range permitted by 
the  legislation  for  infant  formulae  and  follow-on  formulae8.  Young-child  formulae 
are  fortified  in  a  number  of  micronutrients  (e.g.  iron,  vitamin  D),  polyunsaturated 
fatty acids (e.g. alpha-linolenic acid (ALA)) and other substances (e.g. taurine) that 
are commonly present in infant formulae and follow-on formulae and, in many cases, 
are  not  present  (or  present  in  lower  amounts)  in  cow's  milk.  Young-child  formulae 
can  contain  different  sugars  (e.g.  lactose,  sucrose,  glucose,  maltose),  sometimes 
honey and, in certain cases, flavourings (e.g. vanilla). 

2.2 

Market size and value, prices and structure of the market 

The market of young-child formulae experienced growth in almost all the reviewed 
countries  in  the  period  2008-2012.  In  2012,  retail  market  size  can  be  estimated  to 
more than 42 000 tonnes and retail market value to more than €500 million 9.  

The  price  of  young-child  formulae  varies  among  Member  States  depending  on  a 
number of parameters, such as the role of distributors and taxes. Their price is similar 
to (or slightly lower than) that of infant formulae or follow-on formulae and higher 
than  that  of  cow's  milk  or  fortified  milk10.  Young-child  formulae  are  distributed 
through different channels (retailers, specialised stores, websites and pharmacies) and 
prices in pharmacies tend to be slightly higher than in supermarkets.  

The  market  of  young-child  formulae  is  divided  among  a  small  number  of 
manufacturers. Products are manufactured in a few Member States and Switzerland 
and traded to the rest of the EU and to third countries. EU manufacturers are leaders 
in the global scene11.  

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AINIA (2013); EFSA (2013). 
Proteins from goat milk and soy are used in a limited number of products on the market. 
"Infant  formula"  is  a  "food  intended  for  use  by  infants  [i.e.  children  under  the  age  of  12  months] 
during the first months of life and satisfying by itself the nutritional requirements of such infants until 
the  introduction  of  appropriate  complementary  feeding"  (Article  2(2)(c)  of  the  FSG  Regulation). 
"Follow-on formula" is a "food intended for use by infants [i.e. children under the age of 12 months] 
when  appropriate  complementary  feeding  is  introduced  and  which  constitutes  the  principal  liquid 
element  in  a  progressively  diversified  diet  of  such  infants"  (Article  2(2)(d)  of  the  FSG  Regulation). 
Infant formula and follow-on formula are currently regulated by Commission Directive 2006/141/EC 
of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC 
(OJ L 401, 30.12.2006, p. 1), which also provides very similar definitions of these products. The FSG 
Regulation requires the Commission to adopt rules for infant formula and follow-on formula, by the 
means  of  delegated  acts,  taking  into  account  the  existing  requirements  of  Directive  2006/141/EC 
(Article 11(1) and recital 27 of the FSG Regulation). The new Commission delegated Regulation (EU) 
2016/127  of  25  September  2015  supplementing  Regulation  (EU)  No  609/2013  of  the  European 
Parliament and of the Council as regards the specific compositional and information requirements for 
infant  formula  and  follow-on  formula  and  as  regards  requirements  on  information  relating  to  infant 
and young child feeding (OJ L 25, 2.2.2016, p. 1) will repeal and replace Directive 2006/141/EC as of 
22 February 2020. 
AINIA (2013), p. 12-34. Data from 11 EU Member States, representing around 74% of the total EU 
28 population + Switzerland. 
Data provided by Member States and interested parties in the consultation phase (2014). 
Around  two  thirds  of  volumes  of  young-child  formulae  manufactured  in  France  are  produced  for 
export (out of this, one third is exported to other EU Member States and two thirds to third countries) 
and  France  exports  three  times  more  than  the  volume  of  imports,  Secteur  Français  des  Aliments  de 
l'Enfance (SFAE), 2014, Reply to the questionnaire on young-child formulae. 

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2.3 

The marketing of young-child formulae12 

The denomination most commonly used to market young-child formulae in the EU is 
"growing-up  milk".  Other  denominations  used  are,  for  example,  "toddlers'  milk"  or 
"milk-based drink for young children"13.  

Young-child  formulae  are  marketed  as  products  specifically  formulated  for  the 
nutritional needs of young children. Generic statements on the role/suitability of the 
products  in  contributing  to  healthy  growth  of  young  children  are  used  and  the 
products  are  often  presented  as  playing  a  key  role  in  contributing  to  achieve  the 
nutritional requirements of young children and on the difficulty to otherwise achieve 
these requirements through the  normal diet. Nutritional  superiority to cows'  milk is 
often  used  as  a  marketing  argument  (e.g.  "contains  40  times  more  iron  than  cows' 
milk").  

In this context, a variety of nutrition claims are used to describe ingredients that are 
added  to  the  product  and  that  are  considered  beneficial  for  young  children  (e.g. 
"contains vitamin D" or "added omega-3"), or nutrients that the product contains in 
reduced  proportion,  for  improved  suitability  for  young  children  (e.g.  "reduced 
protein"). Authorised health claims on specific ingredients and referring to children's 
development  and  health  are  also  used  and  emphasis  is  put  on  those  nutrients 
considered  critical  for  young  children  (e.g.  "iron  contributes  to  normal  cognitive 
development of children).  

Young-child formulae are marketed for young children aged 1-3 years or, in certain 
cases,  for  narrower  sub-groups  (1-2  and  2-3  years).  The  distinction  with  infant 
formulae  and  follow-on  formulae  is  ensured  by  the  product  denomination  (e.g. 
"toddlers'  milk"),  by  an  indication  on  the  label  of  the  age  range  (e.g.  "+1")  or  of 
corresponding numbers (1 for infant formulae, 2 for follow-on formulae, 3 and 4 for 
young-child formulae) and/or by the use of different colours/design on the label.  

3.  CONSUMERS' PERCEPTION AND BEHAVIOUR 

Young children's feeding practices vary significantly throughout the EU, taking into 
account socioeconomic and cultural differences, differences in the recommendations 
from health care professionals and national authorities and product availability.  
In general terms, it can be reported14 that breastfeeding decreases significantly after 
the age of one year in the Member States, both in terms of rates and intakes. Formula 
products are competing with cows' milk in the diet of young children, and differences 
in  preferences  exist  depending  on  the  Member  State.  Consumption  of  young-child 
formula  is  generally  at  its  highest  in  the  age  range  12-18  months  and  decreases 
afterwards. At the same time, a corresponding increase in the consumption of cow's 
milk can be noted.  

Different  sources  of  information  influence  parents'  and  caregivers'  decisions  on 
young-child formulae, including not only the products' labelling and advertising, but 
also  advice  from  health  care  professionals,  and  exchanges  with  family  and  friends 
with previous experience. The most common arguments put forward by parents and 

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Data provided by Member States and interested parties in the consultation phase (2014). 
In case of soy-based products, the denomination normally used is "growing up drink". 
Data  provided  by  Member  States  and  interested  parties  in  the  consultation  phase  (2014).  The  SWD 
analyses in detail practices in UK, Germany and France. 

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caregivers for using young-child formulae are the suitability to the nutritional needs 
of young children and the superiority to cows' milk.  

In certain Member States, consumption of young-child formulae is recommended by 
national  authorities/health  care  professionals  for  practical  reasons  (i.e.  difficulty  to 
reach adequate intakes for all nutrients through a diversified diet). In other Member 
States, health care professionals and national authorities prefer to recommend cow's 
milk  consumption,  in  the  context  of  a  balanced  diet  (sometimes  together  with 
supplementation).  

4. 

THE LEGAL FRAMEWORK APPLICABLE TO YOUNG-CHILD FORMULAE 

Until  19  July  2016  Directive  2009/39/EC  of  the  European  Parliament  and  of  the 
Council15 (which largely reproduces legislation adopted in 1989) lays down rules on 
foodstuffs  intended  for  particular  nutritional  uses  (so-called  "dietetic  foods").  This 
Directive  defines  dietetic  foods  as  "foodstuffs  which,  owing  to  their  special 
composition  or  manufacturing  process,  are  clearly  distinguishable  from  foodstuffs 
for  normal  consumption,  which  are  suitable  for  their  claimed  nutritional  purposes 
and which are marketed in such a way as to indicate such suitability" (Article 1(2) of 
the Directive). The Directive does not contain an exhaustive list of product categories 
that  are  to  be  considered  dietetic  foods  and,  today,  17  Member  States  and  Norway 
classify young-child formulae as dietetic foods16, on the basis of the definition given 
above.  These  products  must  comply,  as  a  consequence,  with  the  rules  of  Directive 
2009/39/EC,  in  particular,  the  general  rule  whereby  the  nature  or  composition  of 
these  products  "shall  be  such  that  the  products  are  appropriate  for  the  particular 
nutritional use intended" (Article 3(1) of the Directive). They must also comply with 
mandatory  labelling  requirements,  for  example  to  indicate  their  suitability  for  the 
intended purpose (Article 9 of the Directive), and must be notified to the competent 
authorities of the Member States where they are placed on the market (Article 11 of 
the  Directive).  10  Member  States  do  not  classify  young-child  formulae  as  dietetic 
foods17. 

In  2011,  the  Commission  adopted  a  legislative  proposal  to  simplify  the  legal 
framework  applicable  to  dietetic  foods18.  The  proposal  aimed  at  abolishing  the 
obsolete concept of "dietetic food", at repealing Directive 2009/39/EC and replacing 
it  with  a  new  framework  covering  foods  for  certain  vulnerable  groups  of  the 
population, for which specific rules were needed.  

The European Parliament and the Council adopted the proposal in an amended form 
(the FSG Regulation), kept young-child formulae out of the scope of the Regulation 
but  decided  to  require  the  Commission  to  further  analyse  in  a  report  if  specific 
provisions for these products are necessary.  

The  FSG  Regulation  will  enter  into  application  on  20  July  2016.  On  that  date, 
Directive  2009/39/EC  will  be  repealed  and  young-child  formulae  placed  on  the 
market today as "dietetic foods" will be classified as normal foods, fortified in certain 

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Directive  2009/39/EC  of  the  European  Parliament  and  of  the  Council  of  6  May  2009  on  foodstuffs 
intended for particular nutritional uses (OJ L 124, 20.5.2009, p. 21). 
Data provided by Member States (2014).  
Data provided by Member States (2014). Young-child formulae are not on the market in Denmark. 
European  Commission,  2011,  Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the 
Council on food intended for infants and young children and on food for special medical purposes, 
COM (2011) 353. 

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nutrients and targeting a specific sub-group of the population (i.e. young children), as 
it  is  the  case  already  in  the  10  Member  States  that  do  not  classify  young-child 
formulae as dietetic foods. 

Under  the  new  legal  framework,  young-child  formulae  fall  under  the  scope  of 
Regulation (EC) No 1925/2006 of the European Parliament and of the Council19 and 
have to comply with the rules of this Regulation (e.g. on the addition of vitamins and 
minerals and on labelling, presentation and advertising). Article 15 of the Regulation 
allows Member States to establish notification obligations for manufacturers in order 
to monitor the market.  

Young-child formulae need also to comply with the other relevant rules of EU law 
that apply to all foods. For example, young-child formulae must be safe in line with 
the  rules  of  Regulation  (EC)  No  178/2002  of  the  European  Parliament  and  of  the 
Council20.  Food  additives,  pesticide  residues  and  novel  substances  in  young-child 
formulae  must  comply,  respectively,  with  the  rules  of  Regulations  of  the  European 
Parliament and of the Council (EC) No 1333/200821, (EC) No 396/200522 and (EC) 
No  258/9723.  Young-child  formulae  must  provide  food  information,  including  the 
nutrition declaration, in line with the rules of Regulation (EU) No 1169/2011 of the 
European  Parliament  and  of  the  Council24  and  can  only  bear  specific  nutrition  and 
health claims authorised at EU level pursuant to Regulation (EC) No 1924/2006 of 
the  European  Parliament  and  of  the  Council25.  The  use  of  such  claims  must  be  in 
compliance with specific conditions of use as well as with the general principles and 
requirements  of  Regulation  (EC)  No  1924/2006.  In  particular,  Article  3  of  the 
Regulation forbids use of misleading claims as well as of claims giving rise to doubt 
about the safety and/or the nutritional adequacy of other foods. Article 4(1) foresees 
that: "food or certain categories of food must comply with [nutrient profiles] in order 

Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 
on  the  addition  of  vitamins  and  minerals  and  of  certain  other  substances  to  foods  (OJ  L  404, 
30.12.2006, p. 26). 
Regulation  (EC)  No  178/2002  of  the  European  Parliament  and  of  the  Council  of  28  January  2002 
laying  down  the  general  principles  and  requirements  of  food  law,  establishing  the  European  Food 
Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). 
Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 
on food additives (OJ L 354, 31.12.2008, p. 16). 
Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on 
maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending 
Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).  
Regulation  (EC)  No  258/97  of  the  European  Parliament  and  of  the  Council  of  27  January  1997 
concerning  novel  foods  and  novel  food  ingredients  (OJ  L  43,  14.2.1997,  p.  1).  Regulation  (EC)  No 
258/97  shall  be  repealed  on  1  January  2018  by  Regulation  (EU)  2015/2283  of  the  European 
Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 
1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 
of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 
327, 11.12.2015, p. 1). 
Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on 
the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) 
No  1925/2006  of  the  European  Parliament  and  of  the  Council,  and  repealing  Commission Directive 
87/250/EEC,  Council  Directive  90/496/EEC,  Commission  Directive  1999/10/EC,  Directive 
2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 
2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18). The rules 
on  the  nutrition  declaration  of  Regulation  (EU)  No  1169/2011  shall  fully  apply  from  13  December 
2016. 
Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 
on nutrition and health claims made on foods (OJ L 404, 30.12.2006, p. 9). 

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to  bear  nutrition  or  health  claims  (…)"26.  Article  10(3)  foresees  that  references  to 
general benefits of foods for overall good health may only be made if accompanied 
by more specific health claims.  

National rules on young-child formulae only exist in France and were adopted in the 
context of the legislation on dietetic foods27. 

5. 

EFSA'S SCIENTIFIC ADVICE ON YOUNG-CHILD FORMULAE 

In preparation for this report, the European Commission asked for EFSA's scientific 
advice.  In  its  opinion  of  9  October  201328,  EFSA  concluded  that  young-child 
formulae are one of the means to increase n-3 polyunsaturated fatty acids, iron and 
vitamin D intakes of infants and young children (these were identified by EFSA as 
nutrients,  together  with  iodine,  at  risk  of  inadequacy  for  some  infants  and  young 
children in the EU).  

According  to  EFSA,  however,  other  means,  such  as  fortified  cows'  milk,  fortified 
cereals  and  cereal-based  foods,  supplements  or  the  early  introduction  of  meat  and 
fish into complementary feeding and their continued regular consumption, are other 
efficient alternatives to increase intakes of these nutrients. EFSA therefore concluded 
that  no  unique  role  of  young-child  formulae  can  be  identified,  so  they  cannot  be 
considered  as  necessary  to  satisfy  the  nutritional  requirements  of  young  children 
when compared with other foods that may be included in their normal diet.  
In its opinion of 26 June 201429, EFSA noted, in addition, that formulae consumed 
during the first year of life can continue to be used by young children and therefore 
did  not  consider  it  necessary  to  propose  specific  compositional  criteria  for  young-
child formulae. 

6. 

SUMMARY OF THE ISSUES RELATED TO YOUNG-CHILD FORMULAE 

As  described  in  the  previous  sections,  young-child  formulae  are  widespread  in  the 
EU.  The  EU  market  for  these  products  is  growing  and  their  free  circulation  in  the 
Internal Market has been efficient so far. EU manufacturers are leaders in the global 
scene  and,  in  this  context,  it  should  be  noted  that  Codex  Alimentarius  is  currently 
carrying out a revision of STAN 156-198730 that will also include revised rules for 
young-child formulae.  

From a nutritional point of view, young-child formulae are not necessary but are one 
of the means to increase intakes of certain nutrients at risk of inadequacy for some 
young  children  in  the  EU.  There  is  no  reported  safety  issue  with  respect  to  young-
child  formulae  in  the  EU  and  the  content  of  different  nutrients  in  these  products  is 
generally  within  the  ranges  of  permitted  concentrations  in  follow-on  formulae. 
However, some young-child formulae may contain substances (e.g. sugars, flavours) 
at amounts that are generally not recommended for young children (bearing in mind 
the  role  of  sugars  consumption  in  obesity  development,  or  the  impact  of  sugars  or 

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30 

Nutrient profiles, to be established by the Commission, are not set yet and this condition is therefore 
not applicable for the moment.  
Arrêté du 30 mars 1978 fixant les dispositions relatives aux aliments lactés diététiques, JO 24-05-1978 
p. NC 4070-4075. 
EFSA (2013). 
EFSA (2014). 
Codex Alimentarius, Codex Standard for Follow-Up Formula - Codex Stan 156-1987. 

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flavours on the development of young-children's taste). Others may lack the nutrients 
identified  by  EFSA  as  being  at  risk  of  inadequate  intake  for  young  children,  or 
contain nutrients for which there is no such risk.  

These issues can be addressed by the regulatory framework for food in the EU. For 
example,  these  products  must  provide  a  nutrition  declaration  in  line  with  the 
conditions laid down in Regulation (EU) No 1169/2011. In addition, a product may 
bear claims only in line with the rules of Regulation (EC) No 1924/2006. In this case, 
Article  10(3)  of  Regulation  (EC)  No  1924/2006  establishes  that  generic  statements 
referring  to  non-specific  health  benefits  of  the  product  (these  could  include 
statements  on  the  product's  suitability  for  young  children)  can  only  be  used  if 
accompanied by a specific authorised claim (e.g. "calcium and vitamin D are needed 
for normal growth and development of bone in children"). Furthermore, Article 4 of 
Regulation (EC) No 1924/2006 could be used to lay down conditions on the nutrient 
profiles  that  young-child  formulae  should  respect  in  order  to  bear  claims  (thus 
ensuring  the  adequate  composition  of  formulae  bearing  claims).  Article  4  of 
Regulation (EC) No 1924/2006 has however not been applied yet.  

The  marketing  of  young-child  formulae  may  in  certain  cases  be  considered 
misleading  because  it  raises  unjustified  doubts  on  the  nutritional  adequacy  of 
ordinary  foods  (e.g.  to  state  "contains  40  times  more  iron  than  cow's  milk"  when 
cow's milk is not supposed to contain iron). From a legal point of view, however, this 
would  constitute  a  misapplication  of  relevant  provisions  in  EU  legislation  (e.g. 
Article 3 of Regulation (EC) No 1924/2006 which forbids claims that raise doubts on 
the nutritional adequacy of other foods). 

As  of  20  July  2016  all  young-child  formulae  in  the  market  in  the  EU  will  be 
classified in the same way (normal foods fortified in certain nutrients) and will have 
to comply with the relevant existing horizontal rules of EU food law.  

While  no  change  is  expected  in  those  Member  States  that  already  classify  young-
child formulae as food for normal consumption, some developments in the other 17 
Member States can already be anticipated based on the information available at this 
stage. 

For example, the repeal of Directive 2009/39/EC is expected to open up access to the 
market by abolishing the "special status" of dietetic foods and repealing the general 
compositional  requirements  and  the  existing  notification  procedure  applicable  to 
dietetic  foods.  This  could  theoretically  increase  competition  and  offer  of  products, 
and  positively  affect  prices.  While  increased  competition  could  make  it  more 
difficult  for  young-child  formulae  manufacturers  to  be  rewarded  for  their 
investments,  the  opening  up  of  the  market  would  increase  competitiveness  in  the 
general food sector and reduce market distortions. Legal certainty would increase (all 
products would be classified in the same way in the entire EU), the legal framework 
would be simplified and administrative burden would be reduced for business (e.g. 
abolition  of  the  notification  procedure  for  dietetic  foods,  provided  that  Member 
States do not require a notification for fortified foods).  

Some  reformulation  and  relabelling  costs  should  be  expected  (e.g.  compliance  of 
products  today  classified  as  dietetic  foods  with  the  requirements  on  vitamins  and 
minerals in Regulation (EC) No 1925/2006, adjustments of these products' labels to 
remove  references  to  "dietetic  foods"  or  to  comply  with  the  rules  on  the  nutrition 
declaration of Regulation (EU) No 1169/2011 on the provision of food information 
to consumers as from 13 December 2016).  

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One  could  argue  that,  with  the  abolition  of  Directive  2009/39/EC  and  its  general 
requirement  whereby  the  nature  or  composition  of  the  products  "shall  be  such  that 
the  products  are  appropriate  for  the  particular  nutritional  use  intended", 
manufacturers today marketing young-child formulae as dietetic foods would be left 
with  broader  flexibility  in  deciding  the  composition  of  their  products,  which  may 
lead to unsatisfactory composition of these foods. 

Developments in the market after 2016 cannot entirely be foreseen at this stage and 
this  description  can  therefore  not  fully  take  into  account  all  potentially  relevant 
factors.  One  big  element  of  uncertainty  that  could  strongly  influence  future 
developments  in  the  field  is  how  Member  States  will  react  after  Directive 
2009/39/EC is repealed. In any case, all draft national rules will be assessed by the 
Commission in order to verify compliance with EU law. 

7. 

SUMMARY OF MEMBER STATES' AND INTERESTED PARTIES' POSITIONS 

When  consulted  on  whether  specific  action  at  EU  level  is  needed  for  young-child 
formulae, the majority of Member States' experts expressed support for new action. 
Other Member States' experts expressed the different view that no specific action is 
needed for young-child formulae, raising in particular concerns that additional action 
would enhance their status without justification and, ultimately, mislead consumers. 
These national  authorities  also  underlined that horizontal rules of  EU  food  law  can 
efficiently regulate these products (as it is already the case in ten Member States).  

Additional  action  was  supported  by  most  interested parties (both industry and non-
industry related).  

8.  CONCLUSIONS 

In  accordance  with  Article  12  of  the  FSG  Regulation,  this  report  addresses  the 
necessity,  if  any,  of  special  provisions  for  milk-based  drinks  and  similar  products 
intended for young children (i.e. young-child formulae) regarding compositional and 
labelling requirements. 

The following can be concluded: 

•  The European Food Safety Authority (EFSA) issued scientific advice on young-
child formulae in 2013 whereby these products are one of the means to increase 
intakes of certain  nutrients at  risk of inadequacy for  some  young children in the 
EU.  However,  according  to  EFSA,  these  products  have  "no  unique  role"  and 
"cannot  be  considered  as  a  necessity  to  satisfy  the  nutritional  requirements  of 
young  children"  when  compared  to  other  foods  that  may  be  included  in  their 
normal diet; 

•  The  composition  of  young-child  formulae  is  varied.  However,  the  content  of 
different  nutrients  in  these  products  is  generally  within  the  ranges  of  permitted 
concentrations  in  follow-on  formulae.  There  is  no  reported  safety  issue  with 
respect to these products; 

•  The  correct  and  complete  application  of  the  general  framework  of  EU  food  law 
seems sufficient to adequately regulate the composition of young-child formulae 
(e.g. food additives, addition of vitamins and minerals or use of novel substances) 

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and  the  communication  on  the  characteristics  of  the  products  (e.g.  food 
information, nutrition and health claims).  

•  After 20 July 2016, the situation will evolve in those Member States that today 
classify young-child formulae as dietetic foods as a consequence of the repeal of 
Directive  2009/39/EC  and  its  general  requirement  whereby  the  nature  or 
composition of the products "shall be such that the products are appropriate for 
the  particular  nutritional  use  intended".  Many  developments  after  2016  cannot 
be  foreseen  at  this  stage  given  that  no  concrete  information  exists  on  how 
operators or consumers will adapt to the new legal framework or on how Member 
States  will  react  at  national  level  to  the  impossibility  to  continue  using  the 
aforementioned provision of Directive 2009/39/EC. In any case, all draft national 
rules will be assessed by the Commission in order to verify compliance with EU 
law. 

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