COMMISSION STAFF WORKING DOCUMENT Young-child formulae: background information Accompanying the document 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  
SWD(2016) 99 final 

COMMISSION STAFF WORKING DOCUMENT 

Young-child formulae: background information 

Accompanying the document 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

on young-child formulae 

{COM(2016) 169 final} 

EN 

   EN 

 
 
 
 
  
 
TABLE OF CONTENTS 

Introduction ................................................................................................................................ 2 

1.  Methodology and sources................................................................................................... 4 

2.  Terminology ....................................................................................................................... 6 

3.  The market of young-child formulae in the EU ................................................................. 8 

3.1. 
3.2. 
3.3. 

Products' presence in the different Member States .................................................. 8 
Products' composition and characteristics ............................................................... 9 
Market size and value, prices and structure of the market..................................... 13 
3.3.1.  Size of the market of young-child formulae....................................................... 13 
3.3.2.  Value of the market of young-child formulae .................................................... 15 
3.3.3.  Price of young-child formulae............................................................................ 15 
3.3.4.  Structure of the market of young-child formulae............................................... 17 
The marketing of young-child formulae ................................................................ 19 
4.  Consumer's perception and behaviour.............................................................................. 22 

3.4. 

4.2. 

4.1. 

United Kingdom..................................................................................................... 22 
4.1.1.  Consumption data............................................................................................... 22 
4.1.2.  Parents' and other caregivers' perception of young-child formulae ................... 24 
4.1.3.  Recommendations of health care professionals and national authorities........... 24 
Germany................................................................................................................. 25 
4.2.1.  Consumption data............................................................................................... 25 
4.2.2.  Parents' and other caregivers' perception of young-child formulae ................... 27 
4.2.3.  Recommendations of health care professionals and national authorities........... 28 
France..................................................................................................................... 30 
4.3.1.  Consumption data............................................................................................... 30 
4.3.2.  Parents' and other caregivers' perception of young-child formulae ................... 31 
4.3.3.  Recommendations of health care professionals and national authorities........... 34 
Summary for Chapter 4.......................................................................................... 35 
5.  Existing legal framework applicable to young-child formulae ........................................ 36 

4.3. 

4.4. 

EU rules applicable to young-child formulae when classified as dietetic foods ... 36 
EU rules applicable to young-child formulae when classified as food for normal 

5.1. 
5.2. 
consumption fortified in certain nutrients ............................................................................ 38 
Other horizontal EU rules applicable to young-child formulae............................. 39 
5.3. 
National rules applicable to young-child formulae................................................ 42 
5.4. 
Young-child formulae and the FSG Regulation .................................................... 43 
5.5. 
6.  EFSA's scientific advice on young-child formulae .......................................................... 45 

7.  Summary of Member States' and interested parties' positions ......................................... 48 

Annex I..................................................................................................................................... 50 

Annex II.................................................................................................................................... 51 

2 

 
 
 
 
INTRODUCTION 

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  ("the  Regulation  on  Food  for  Specific  Groups",  or  "FSG 
Regulation")1  introduces  compositional  and  information  requirements  for  certain  foods  for 
specific  groups  of  the  population.  The  Regulation  repeals  Directive  2009/39/EC  of  the 
European Parliament and of the Council on foodstuffs intended for particular nutritional uses2 
(so called "dietetic foods"), abolishes the concept of "dietetic food" and revises the framework 
applicable to these products.  

Article  12  of  the  Regulation  provides  that:  "By  20  July  2015,  the  Commission  shall,  after 
consulting the Authority, present to the European Parliament and to the Council a report on 
the necessity, if any, of special provisions for milk-based drinks and similar products intended 
for young children  regarding  compositional and labelling requirements and, if appropriate, 
other  types  of  requirements.  The  Commission  shall  consider  in  the  report,  inter  alia,  the 
nutritional  requirements  of  young  children,  the  role  of  those  products  in  the  diet  of  young 
children  and  whether  those  products  have  any  nutritional  benefits  when  compared  to  a 
normal diet for a child who is being weaned. Such a report may, if necessary, be accompanied 
by an appropriate legislative proposal." 

As  explained  in  recital  31  of  the  Regulation,  the  rationale  for  this  request  is  the  increasing 
number  of  milk-based  drinks  and  similar  products  being  placed  on  the  Union  market  and 
promoted  as  particularly  suitable  for  young  children.  Such  products,  which  can  be  derived 
from protein of animal or vegetable origin such as cows’ milk or soy, are often marketed as 
"growing up milks" or "toddlers’ milks" or with similar terminology. No specific composition 
requirement for these products is set in EU legislation. Different views exist on whether these 
products  are  necessary  to  satisfy  the  nutritional  needs  of  young  children  or  have  any 
nutritional benefits when compared to other foods that can constitute the normal diet of young 
children.   

This Staff Working Document (SWD) accompanies the Commission report to the European 
Parliament and to the Council on young-child formulae that meets the obligation set for the 
Commission  by  Article  12  of  the  FSG  Regulation.  The  SWD  provides  more  detailed 
information on the findings of the Commission report and is structured as follows: 

• 

• 

• 

• 

it  provides  a  description  of  the  methodology  and  the  sources  used  for  drafting  the 
report and an explanation of the relevant terminology; 

it provides a detailed picture of the market of young-child formulae in the EU;  

it  provides  a  description  of  consumer's  perception  and  behaviour  regarding  these 
products; 

it provides a description of the legal framework applicable to young-child formulae in 
the EU; 

1 

2 

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). 
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). 

3 

 
 
                                                 
• 

• 

it  recalls  the  main  points  of  the  European  Food  Safety  Authority  (EFSA)'s  scientific 
assessment on these products; 

it summarizes the positions of Member States and interested parties in the consultation 
phase. 

4 

 
 
 
1.  METHODOLOGY AND SOURCES 

As required by the FSG Regulation, the Commission consulted EFSA in preparation for the 
report  on  young-child  formulae.  The  report  and  this  SWD  build  upon  the  two  opinions 
adopted by EFSA on the subject: 

•  "Scientific Opinion on nutrient requirements and dietary intakes of infants and young 

children in the European Union"3, adopted on 9 October 2013; 

•  "Scientific  Opinion  on  the  essential  composition  of  infant  and  follow-on  formulae"4, 

adopted on 26 June 2014. 

The two opinions are summarised in Chapter 6 of this SWD. 

The  report  and  this  SWD  are  also  based  on  the  study  carried  out  by  the  Asociación  de 
Investigación de la Industria Agroalimentaria (AINIA) upon request of EFSA in preparation 
for  the  two  abovementioned  opinions:  "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"5.  The 
AINIA study provides detailed information on the market of young-child formulae in the EU 
and has served as a basis for the description of this market sector in Chapter 3 of this SWD.  

The report and this SWD take also into account the outcome of consultations with: 

•  national competent authorities in the context of the Expert Group on food intended for 
infants  and  young  children,  food  for  special  medical  purposes  and  total  diet 
replacement for weight control6 and  

•  interested parties in the context of the Working Group of the Advisory Group on the 

Food Chain and Animal and Plant Health on young-child formulae7. 

More specifically, a questionnaire on young-child formulae was sent on 27 May 2014 to all 
Member States, and on 3 June 2014 to Members of the Advisory Group on the Food Chain 
and  Animal  and  Plant  Health  and  selected  interested  parties.  The  targeted  consultation  was 
open until 18 July 2014 and replies received past the deadline were also considered.   

On the basis of the replies received to the questionnaire, a Working Document was submitted 
to the attention of the Working Group of the Advisory Group on the Food Chain and Animal 
and  Plant  Health  on  young-child  formulae  and  was  discussed  in  a  dedicated  meeting  on  19 

3 

4 

5 

6 

7 

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. 
Expert group on food intended for infants and young children, food for special medical purposes and total 
diet replacement for weight control, Reference E02893 in the Register of Commission Expert Groups and 
other similar entities,  
http://ec.europa.eu/food/safety/labelling_nutrition/special_groups_food/expert_group/index_en.htm 
Advisory Group on the Food Chain and Animal and Plant Health, Reference E00860 in the Register of 
Commission Expert Groups and other similar entities, 
http://ec.europa.eu/dgs/health_food-safety/advisory_groups_action_platforms/advisory_group_en.htm 

5 

 
 
                                                 
 
 
September 2014. That Working Document provided a summary of the contributions received 
to the questionnaire and described possible means for dealing with this subject at EU level, in 
order to obtain further feedback from interested parties. 

That same Working Document was submitted to the attention of Member States together with 
a  summary  record  of  the  discussion  with  interested  parties8.  The  two  documents  were 
discussed in a dedicated meeting of the Expert Group on food intended for infants and young 
children, food for special medical purposes and total diet replacement for weight control on 
10 October 2014.  

An  additional  Working  Document  describing  an  alternative  approach  (non-legislative 
measures),  which  was  not  covered  in  the  first  round  of  consultations,  was  submitted  to  the 
attention of the Working Group  of  the  Advisory  Group  on  the  Food  Chain  and  Animal  and 
Plant  Health  on  young-child  formulae  and  was  discussed  in  a  dedicated  meeting  on  17 
February  2015.  That  same  Working  Document  was  submitted  to  the  attention  of  Member 
States and discussed in a meeting of the Expert Group on food intended for infants and young 
children, food for special medical purposes and total diet replacement for weight control on 
18 February 2015.  

A  summary  of  the  comments  of  the  Member  States  and  interested  parties  is  provided  in 
Chapter 7 of this SWD. 

Additional sources to the report and the SWD will be quoted in footnotes. 

8 

During the preparation of the report, position papers were also provided by interested parties that were not 
originally consulted by the Commission. These documents were also considered in the preparation of the 
report. 

6 

 
 
                                                 
2.  TERMINOLOGY 

For the purposes of the report, the following terminology shall be used:  

- 

Infant: a child under the age of 12 months (Article 2(2)(a) of the FSG Regulation). 

-  Young  child:  a  child  aged  between  one  and  three  years  (Article  2(2)(b)  of  the  FSG 

Regulation). 

-  Young-child  formula:  this  will  be  the  denomination  used  to  refer  to  the  products 
subject  of  the  report,  namely  milk-based  drinks  and  similar  protein-based  products 
specifically processed/formulated and intended to satisfy the nutritional requirements 
of young children aged 1-3 years.   

Different  terminology  is  normally  used  to  refer  to  these  products  (e.g.  "growing-up 
milk"  or  "toddlers'  milks").  It  is,  however,  considered  preferable  not  to  use  the 
denomination "growing up milk", as this would imply a particular beneficial effect on 
growth  for  young  children.  Similarly  it  is  preferable  not  to  use  the  term  "toddlers' 
milk", as a "young child" is better defined by age in the legislation9.  

-  Fortified  milks:  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.  

- 

Infant  formula:  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  (Article  2(2)(c)  of  the  FSG  Regulation).  Infant 
formula is currently regulated by Directive 2006/141/EC10, which also provides a very 
similar definition of infant formula. 

-  Follow-on formula: 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 (Article 2(2)(d) of the FSG Regulation). 
Follow-on  formula  is  currently  regulated  by  Directive  2006/141/EC,  which  also 
provides a very similar definition of follow-on formula. 

-  Follow-up Formula: food intended for use as a liquid part of the weaning diet for the 
infant from the 6th month on and for young children (Art. 2.1.1 - Codex Alimentarius 
Standard for Follow-Up Formula11).  

-  Baby food: food 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,  excluding:  (i) 
processed cereal-based food; and (ii) milk-based drinks and similar products intended 
for  young  children;  (Article  2(2)(f)  of  the  FSG  Regulation).  Baby  food  is  currently 

9 
10 

11 

EFSA also referred to "young-child formulae" in its two opinions on the subject. 
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).  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).  Directive  2006/141/EC  will  be  repealed  and  replaced  from  22  February  2020  by 
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) 
Codex Alimentarius, Codex Standard for Follow-Up Formula - Codex Stan 156-1987. 

7 

 
 
                                                 
regulated  by  Directive  2006/125/EC12,  which  provides  a  very  similar  definition  of 
baby food. 

-  Nutrition claim: any claim which states, suggests or implies that a food has particular 
beneficial nutritional properties due to: (a) the energy (calorific value) it (i) provides; 
(ii)  provides  at  a  reduced  or  increased  rate;  or  (iii)  does  not  provide;  and/or  (b)  the 
nutrients  or  other  substances  it  (i)  contains;  (ii)  contains  in  reduced  or  increased 
proportions;  or  (iii)  does  not  contain  (Article  2(2)(4)  of  Regulation  (EC)  No 
1924/2006)13. 

-  Health  claim:  any  claim  that  states,  suggests  or  implies  that  a  relationship  exists 
between a food category, a food or one of its constituents and health (Article 2(2)(5) 
of Regulation (EC) No 1924/2006). 

- 

Interested parties: all components of the society that showed the Commission services 
an interest in young-child formulae during the preparation of the report. The concept 
includes, by way of example: industry stakeholders, consumers' associations and other 
NGOs. It excludes institutional counterparts like Member States or EFSA. A full list 
of such interested parties is provided in Annex. 

12 

13 

Commission  Directive  2006/125/EC  of  5  December  2006  on  processed  cereal-based  foods  and  baby 
foods for infants and young children (OJ L 339, 6.12.2006, p. 16). 
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). 

8 

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

This Chapter provides a detailed picture of the market of young-child formulae in the EU. It 
first  gives  an  account  of  the  presence  of  the  products  in  the  different  Member  States  and 
describes  the  products'  composition  and  characteristics.  It  then  provides  an  overview  of  the 
size of the market of young-child formulae, as well as information on the market's value and 
structure,  including  information  on  products'  price.  It  finally  describes  how  young-child 
formulae are marketed in the EU, providing information on a number of aspects, such as what 
sales denomination is used, what claims are made and what population groups are targeted. 
This overview only covers young-child formulae and does not cover fortified milks14.  

3.1. Products' presence in the different Member States 
Hundreds  of  young-child  formulae  are  present  on  the  EU  market.  Available  data15  from  17 
Member  States  representing  90  %  of  the  total  EU28  population  (calculated  from  Eurostat 
data), with significant geographic representation of the different areas of Europe, have listed 
244 different young-child formulae from 62 food business operators currently available on the 
market  (Austria  (n  =  18),  Belgium  (n  =  17),  Czech  Republic  (n  =  14),  Denmark  (n  =  0), 
Finland (n = 3), France (n = 34), Germany (n = 25), Greece (n = 11), Hungary (n = 5), Ireland 
(n = 10), Italy (n = 24), Netherlands (n = 16), Poland (n = 13), Portugal (n = 8), Spain (n = 
32), Sweden (n = 2) and United Kingdom (n = 12)).   

The  abovementioned  data  are  represented  in  Figure  1,  showing  that  the  countries  with  the 
greatest number of products collected were France and Spain, followed by Germany and Italy. 
In  contrast,  the  countries  with  the  smallest  number  of  products  collected  were  Finland, 
Sweden and Denmark.  

14 

15 

During the consultation phase, Member States and interested parties were asked to provide any available 
information on fortified milks. On the basis of the replies received, it appears that a number of fortified 
milk products exist in almost all Member States. The products are fortified with a series of micronutrients 
(e.g. very often with vitamin D, which is also mandatorily added to milk in some Member States) and in a 
limited number of cases and Member States with n-3 polyunsaturated fatty acids. Their protein content is 
normally  not  modified.  These  products  are  marketed  at  a  lower  price  than  young-child  formulae  and 
target  the  general  population  or  sub-groups  thereof  (e.g.  children)  with  specific  nutrition  and  health 
claims (e.g. fortified in vitamin D for bone health, or fortified in omega-3 for cardiovascular health). They 
however  never  target  young  children  only.  During  the  consultation  phase,  several  Member  States  also 
underlined  that  these  fortified  milk  products  can  contain  fruit  or  flavours  (e.g.  vanilla  or  chocolate). 
Different national competent authorities, 2014, Reply to the questionnaire on young-child formulae. 
AINIA  (2013)  p.  5-9;  EFSA  (2013),  p.  13;  Denmark  2014,  Reply  to  the  questionnaire  on  young-child 
formulae. 

9 

 
 
                                                 
Figure 1 - Number of products per Member State (source: AINIA data) 

Products per Member State

s
t
c
u
d
o
r
p
f
o
r
e
b
m
u
N

40
35
30
25
20
15
10
5
0

34

25

18

17

14

11

10

5

3

0

32

24

16

13

8

12

2

AT BE CZ DK FI FR DE EL HU IE IT NL PL PT ES SE UK

Member States

3.2. Products' composition and characteristics 

Almost half of the young-child formulae analysed by AINIA were in liquid form (44.7%, n = 
109) and the remaining were marketed in the form of powder to be reconstituted. The great 
majority  of  the  reviewed  young-child  formulae  (96%,  n  =  234)  is  based  on  cow's  milk  as  a 
source  of  protein.  Goat  milk  and  soy  are  the  sources  of  protein  used  in  three  and  seven 
formulae, respectively16.  

The  energy  content  of  the  analysed  young-child  formulae  is  varied,  and  so  is  their 
composition17. Tables 1-3 below provide an overview of the maximum, minimum and median 
values of the different nutrients present in the young-child formulae reviewed by AINIA.  

Table 1 - Maximum, minimum and median content of different macronutrients (source: AINIA data) 

Units 

Max (/100 kcal) 

Min (/100 kcal) 

Median (/100 kcal) 

Nutrient 

Protein 

Casein 

Whey Protein 

W/C (Whey/Casein) Ratio 

Carbohydrates 

Sugars 

Lactose 

Sucrose 

Glucose 

Maltose 

Maltodextrin 

Fat 

Saturated Fat 

g 

g 

g 

g 

g 

g 

g 

g 

g 

g 

g 

g 

g 

16 
17 

EFSA (2013), p. 13; AINIA (2013) p. 9.  
AINIA (2013); EFSA (2013). 

2.0 

0.1 

0.4 

0.5 

7.3 

3.1 

0.1 

0.6 

0.0 

0.1 

1.4 

3.0 

0.2 

2.6 

1.7 

0.7 

1.5 

12.6 

9.9 

9.0 

2.1 

0.5 

0.2 

4.1 

4.3 

1.4 

6.7 

2.4 

1.2 

6.3 

15.4 

13.7 

13.5 

10.4 

1.8 

5.0 

11.2 

5.7 

4.3 

10 

 
 
 
 
 
                                                 
Monounsaturated 

Polyunsaturated 

Linoleic Acid n-6 

Arachidonic Acid (ARA) 

Alpha Linolenic Acid n-3 

Eicosapentaenoic acid (EPA) 

Docosahexaenoic acid (DHA) 

Fibre 

g 

g 

g 

g 

mg 

mg 

mg 

g 

3.0 

3.4 

2.4 

0.2 

589.2 

81.8 

42.6 

2.4 

0.7 

0.4 

0.1 

0.0 

0.0 

11.8 

0.4 

0.0 

1.9 

0.9 

0.8 

0.0 

103.0 

19.0 

6.4 

0.8 

Table 2 - Maximum, minimum and median content of different minerals (source: AINIA data) 

Nutrient 

Sodium 

Potassium 

Chloride 

Calcium 

Phosphorus 

Magnesium 

Iron 

Zinc 

Copper 

Manganese 

Fluoride 

Selenium 

Iodine 

Chromium 

Molybdenum 

Units 

Max (/100 kcal) 

Min (/100 kcal) 

Median (/100 kcal) 

mg 

mg 

mg 

mg 

mg 

mg 

mg 

mg 

mg 

mg 

mg 

µg 

µg 

µg 

µg 

85.7 

322.9 

166.2 

270.8 

185.7 

49.0 

2.9 

3.0 

0.1 

1.0 

0.1 

6.7 

54.0 

1.5 

4.4 

15.9 

85.9 

14.1 

77.1 

46.4 

6.6 

1.0 

0.1 

0.0 

0.0 

0.0 

1.0 

0.0 

1.4 

4.1 

40.4 

126.8 

75.0 

126.9 

77.6 

10.4 

1.8 

1.1 

0.1 

0.0 

0.0 

2.4 

20.0 

1.4 

4.2 

Table 3 - Maximum, minimum and median content of vitamins and some other nutrients (source: AINIA data) 

Nutrient 

Vitamin A 

Vitamin D 

Vitamin E 

Vitamin K 

Vitamin C 

Thiamin 

 Riboflavin 

Niacin 

Vitamin B6 
Folic Acid 

Vitamin B12 
Biotin 

Pantothenic acid 

Choline 

Inositol 

Taurine 

Carnitine 

Units 

Max (/100 kcal) 

Min (/100 kcal) 

Median (/100 kcal) 

9.6 

0.9 

0.0 

0.0 

2.2 

0.0 

0.0 

0.0 

0.0 

0.0 

0.0 

0.0 

0.0 

0.8 

1.7 

0.3 

1.1 

101.6 

2.1 

1.6 

7.5 

15.4 

0.1 

0.2 

0.9 

0.1 

22.4 

0.3 

3.1 

0.7 

14.9 

6.4 

8.1 

2.1 

µg 

µg 

mg 

µg 

mg 

mg 

mg 

mg 

mg 

µg 

µg 

µg 

mg 

mg 

mg 

mg 

mg 

176.3 

6.0 

7.0 

16.3 

34.8 

1.2 

1.2 

4.1 

0.7 

42.2 

0.9 

7.5 

6.8 

123.2 

14.9 

19.4 

3.7 

11 

 
 
The  amounts  of  nutrients  reported  by  AINIA  were  generally  in  the  ranges  reported  by 
Specialised Nutrition Europe (SNE)18 and in the review by Crawley and Westland19. 

Table  4  below  provides  a  comparison  carried  out  by  EFSA  of  the  nutrient  composition  and 
energy  content  of  the  cow's  milk  based  young-child  formulae  reviewed  by  AINIA  with  the 
essential composition of cow's milk based infant formulae and follow-on formulae according 
to  Directive  2006/141/EC  and  the  nutrient  composition  and  energy  content  of  full  fat  cow's 
milk20. 

The  protein  content  of  the  reviewed  young-child  formulae  is  normally  lower  than  the  mean 
protein  content  of  cow's  milk  and  is,  in  most  cases,  within  the  permitted  range  for  infant 
formulae and follow-on formulae, as laid down in Directive 2006/141/EC. The carbohydrate 
content of the reviewed young-child formulae is normally higher than the mean carbohydrate 
content of cow's milk and, in most cases, within the permitted range for infant formulae and 
follow-on  formulae.  In  addition,  while  lactose  is  the  primary  sugar  present  in  cow's  milk, 
different sugars can be present in young-child formulae (lactose, sucrose, glucose, maltose). 
These  sugars  are  also  used  in  infant  formulae  and  follow-on  formulae,  in  line  with  the 
conditions  laid  down  in  Directive  2006/141/EC.  Sometimes  honey  is  added  to  young-child 
formulae21. The fat content of the reviewed young-child formulae is normally lower than the 
mean  fat  content  of  full  fat  cow's  milk  and,  in  most  cases,  within  the  permitted  range  for 
follow-on formulae. 

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. As underlined by EFSA22, 
in comparison with cow's milk, currently marketed young-child formulae contain more ALA, 
docosahexaenoic  acid  (DHA)  (if  added),  iron  and  vitamin  D  but  similar  amounts  of  iodine. 
The  median  content  of  these  nutrients  in  the  reviewed  young-child  formulae  is  within  the 
range  of  permitted  concentrations  in  follow-on  formulae  and,  except  for  iron,  also  in  infant 
formulae. These nutrients have been identified as critical nutrients by EFSA, as will be further 
described in Chapter 6.  

Table 4 - Nutrient composition and energy content of cow’s milk based young-child formulae currently on the 
EU market, of infant and follow-on formulae (cow’s milk based) as per Directive 2006/141/EC and of full-fat 
cow’s milk (source: EFSA, based on AINIA data) 

Young-child formula  
(cow’s milk based) 23 

P5  Median 

P95 

Follow-on formula  
(cow’s milk based) 
Min 

Max 

Infant formula 
(cow’s milk based) 
Min 

Max 

Cow’s milk, 
full fat 
Mean 

209.0 

281.0 

339.0 

251.0 

293.0 

251.0 

293.0 

289.0 

50.0 

67.0 

81.0 

P524  Median 

P95 

60.0 

Min 

70.0 

Max 

60.0 

Min 

70.0 

69.0 

Max 

Mean 

Energy  
(kJ/100 g) 
Energy 
(kcal/100 g) 
Nutrient per 

18 

19 

20 
21 
22 
23 
24 

Specialised Nutrition Europe (SNE), 2013, data shared with the European Commission and representing 
predominantly EU countries where SNE is present through one of its members associations. 
Crawley  H  and  Westland  S,  2013,  Fortified  milks  for  children  -  A  worldwide  review  of  fortified  milks 
marketed for children over 1 year of age, First Steps Nutrition Trust. 
EFSA (2013), p. 99-100.  
Belgium, 2014, Reply to the questionnaire on young-child formulae. 
EFSA (2013), p. 74. 
Based on 234 products. 
Percentiles are based on formulae containing the nutrient. 

12 

 
 
 
 
                                                 
Young-child formula  
(cow’s milk based) 23 

P5  Median 

P95 

Follow-on formula  
(cow’s milk based) 
Min 

Max 

Infant formula 
(cow’s milk based) 
Min 

Max 

Cow’s milk, 
full fat 
Mean 

2.1 

7.0 

2.6 

8.1 

3.6 

15 

11.1 

12.6 

14.3 

3.5 

0.4 

1.1 

2.2 

4.3 

1.4 

4.1 

6.4 

4.8 

2.1 

14.3 

22.3 

1.8 

– 

9.0 

4.0 

– 

– 

– 

3.5 

< 12 

14.0 

6.0 

– 

– 

– 

1.8 

– 

9.0 

4.4 

– 

– 

– 

3.0 

< 12 

14.0 

6.0 

– 

– 

– 

57.6 

103.0 

169.0 

> 50 

240 

>50 

240 

500.0 

758.0 

1 043.0 

300.0 

1 200.0 

300.0 

1 200.0 

100 kcal 

Protein  
(g/100 kcal) 
Taurine25  
(mg/100 kcal)  
Carbohydrates  
(g/100 kcal) 
Fat  
(g/100 kcal) 
SFA  
(g/100 kcal) 
ARA26  
(mg/100 kcal)  
DHA 27 
(mg/100 kcal)  
ALA 28 
(mg/100 kcal)  
LA 29 
(mg/100 kcal)  
Sodium  
(mg/100 kcal) 
Chloride  
(mg/100 kcal) 
Potassium  
(mg/100 kcal) 
Calcium  
(mg/100 kcal) 
Phosphorus  
(mg/100 kcal) 
Copper  
(µg/100 kcal) 
Iodine  
(µg/100 kcal) 
Iron  
(mg/100 kcal) 
Magnesium  
(mg/100 kcal) 
Manganese  
(µg/100 kcal) 
Selenium  
(µg/100 kcal) 
Zinc  
(mg/100 kcal) 
Vitamin A  
(µg RE/100 kcal) 
Vitamin D  
(µg/100 kcal) 
Vitamin E  
(mg TE/100 kcal) 

Vitamin K 
(µg/100 kcal) 

27.6 

40.3 

57.1 

61.2 

75.0 

114.0 

101.0 

127.0 

199.0 

94.4 

127.0 

220.0 

58.4 

77.3 

134.0 

35.0 

61.5 

118.0 

12.2 

20.2 

34.8 

1.3 

8.1 

5.9 

1.4 

0.7 

1.8 

2.4 

10.4 

20.0 

14.6 

106.0 

1.6 

1.2 

5.5 

2.0 

77.8 

102.0 

141.0 

1.4 

0.9 

2.1 

1.6 

3.3 

3.1 

4.5 

7.5 

11.8 

60.0 

160.0 

160.0 

140.0 

90.0 

100.0 

50.0 

2.0 

15.0 

100.0 

9.0 

1.5 

180.0 

3.0 

5.0 

25.0 

20.0 

50.0 

60.0 

50.0 

25.0 

35.0 

10.0 

0.3 

5.0 

1.0 

1.0 

0.5 

60.0 

1.0 

0.5/g PUFA, 
not < 0.5 mg/ 
100 kcal 
4.0 

20.0 

50.0 

60.0 

50.0 

25.0 

35.0 

10.0 

0.6 

5.0 

1.0 

1.0 

0.5 

60.0 

1.0 

0.5/g PUFA, 
not < 0.5 mg/
100 kcal 
4.0 

13 

25 
26 
27 
28 
29 

In 31% of all young-child formulae. 
In 12% of all young-child formulae. 
In 13% of all young-child formulae. 
In 78% of all young-child formulae. 
In 80% of all young-child formulae. 

4.8 

– 

6.8 

6.1 

– 

0.0 

0.0 

0 

70.0 

64.3 

146.5 

215.1 

176.7 

138.3 

0.0 

23.0 

< 0.1 

16.8 

0.0 

1.9 

0.6 

60.0 

160.0 

160.0 

140.0 

90.0 

100.0 

50.0 

1.3 

15.0 

100.0 

9.0 

1.5 

180.0 

57.5 

2.5 

5.0 

25.0 

0.1 

0.1 

0.0 

 
 
 
 
                                                 
Young-child formula  
(cow’s milk based) 23 

P5  Median 

0.07 

0.12 

0.14 

0.20 

0.06 

0.10 

P95 

0.27 

0.35 

0.30 

0.18 

0.27 

0.59 

3.1 

6.6 

2.2 

7.3 

Follow-on formula  
(cow’s milk based) 
Min 

Max 

Infant formula 
(cow’s milk based) 
Min 

Max 

Cow’s milk, 
full fat 
Mean 

0.06 

0.08 

0.3 

0.4 

0.06 

0.08 

0.3 

0.4 

0.035 

0.175 

0.035 

0.175 

0.1 

1.5 

0.5 

7.5 

0.1 

1.5 

0.5 

7.5 

22.4 

38.6 

10.0 

50.0 

10.0 

50.0 

0.57 

0.90 

0.42 

0.71 

3.1 

1.3 

0.3 

0.4 

1.5 

2.0 

0.3 

0.4 

1.5 

2.0 

8.7 

15.9 

23.4 

10.0 

30.0 

10.0 

30.0 

10.0 

14.9 

4.0 

6.3 

23.0 

13.5 

– 

– 

– 

– 

7 

4 

12 

40 

0.0 

0.3 

0.0 

0.7 

4.3 

9.1 

1.0 

0.6 

1.9 

Thiamine  
(mg/100 kcal) 
Riboflavin  
(mg/100 kcal) 
Pyridoxine 
(mg/100 kcal) 
Cobalamin  
(mg/100 kcal) 
Biotin  
(µg/100 kcal) 
Folate  
(µg/100 kcal) 
Niacin  
(mg/100 kcal) 
Pantothenic acid  
(mg/100 kcal) 
Vitamin C  
(mg/100 kcal) 
Choline30  
(mg/100 kcal)  
Inositol31  
(mg/100 kcal)  

The review from AINIA does not cover the presence of flavouring substances in young-child 
formulae, as this was not requested by EFSA for the purposes of its work. It has however been 
reported that at least certain young-child formulae in the market in the EU contain flavourings 
(e.g. vanilla)32. 

3.3. Market size and value, prices and structure of the market 

This  section  focuses  on  a  number  of  different  aspects  related  to  the  market  of  young-child 
formulae: market size and value, products' price and market structure. 

3.3.1.  Size of the market of young-child formulae 
On  the  basis  of  available  data33  from  11  EU  Member  States  (Austria,  Belgium,  Finland, 
France,  Germany,  Italy,  Netherlands,  Portugal,  Spain,  Sweden,  and  the  UK),  representing 
around 74% of the total EU28 population + Switzerland, the combined retail market size for 
young-child  formulae  in  terms  of  volume  for  these  countries  can  be  estimated  to  more  than 
42 000  tonnes  in  2012  (including  formulae  in  liquid  and  powder  form).  As  it  is  shown  in 
Figure  2  below,  the  biggest  markets  in  terms  of  volume  in  2012  were  France  and  Spain, 
followed  by  Italy,  UK  and  Germany.  The  smallest  reviewed  markets  were  Finland  and 
Sweden. 

30 
31 
32 

33 

In 34% of all young-child formulae. 
In 11% of all young-child formulae. 
Crawley H and Westland S, (2013), p. 53-58; First Steps Nutrition Trust, 2014, Reply to the questionnaire 
on young-child formulae. 
AINIA (2013), p. 12-34. This market share represents the top players accounting for 80% of the market in 
those countries. 

14 

 
 
 
 
 
 
                                                 
Figure 2 – Market size (volume as tonnes) per country – 2012 (source: AINIA data) 

Market size per country

15700

5120

4790

3975

1405

435

1889

624

350

~
0

~
0

s
e
n
n
o
T

20000

15000

10000

7760

5000

0

ES PT NL IT DE UK FR BE AT

SW FI SE

Member States + Switzerland

In the period 2008-2012, the market experienced growth in all the abovementioned countries 
with the exception of Portugal (where it decreased by 10.3% with a compound annual growth 
rate of -2.7%) and ranged from a 2.9% growth in Switzerland (compound annual growth of 
0.7%) to a 265.7% growth in Germany (compound annual growth of 38.3%). Notable growths 
were also reported in Spain (45.6% growth, with a compound annual growth of 9.8%), Italy 
(44.6% growth with a compound annual growth of 9.7%) and the Netherlands (40.2% growth 
with a compound annual growth of 8.8%).  

15 

 
 
 
 
3.3.2.  Value of the market of young-child formulae 
In  terms  of  market  value,  the  same  data  from  AINIA34  allow  to  estimate  a  combined  retail 
market  value  for  young-child  formulae  of  more  than  €500  million  for  the  12  countries  in 
2012. As it is shown in Figure 3 below, the biggest markets in terms of value in 2012 were 
France and Italy, followed by Spain, UK and Germany.  
Figure 3 – Market value (million €) per country (source: AINIA data) 35 

3.3.3.  Price of young-child formulae 

Figure 4 below shows the differences in retail market unit price for young-child formulae as 
reported  by  AINIA36.  Among  EU  Member  States,  in  2012,  prices  were  highest  in  Austria 
(€15-17.5 per kg) and lowest in Spain (€7.5-10 per kg).  

34 

35 
36 

AINIA (2013), p. 32. Data are only available in a chart. The value of €500 million should be considered 
an approximation based on rounded values. 
AINIA (2013), p. 32. 
AINIA  (2013),  p.  34.  Data  are  only  available  in  a  chart  and,  therefore,  referred  to  in  ranges  for 
presentational  purposes.  The  price  per  kg  reported  by  AINIA  does  not  allow  distinguishing  between 
products sold in powder and liquid form. 

16 

 
 
 
 
 
 
                                                 
Figure 4 – Retail market unit price (€ per kg) (source: AINIA data) 37 

Stakeholders confirmed38 that the price of young-child formulae can vary. They noted that a 
number of market parameters, such as the influence of retailers in setting the final price, food 
taxes, VAT etc. play a role in the final price paid by the consumer.  
Information  received  from  national  competent  authorities39  also  confirmed  that  prices  differ 
depending on Member State, brand, product presentation (liquid vs powder) and distribution 
channel.  More  specifically,  information  received  from  national  competent  authorities  shows 
that  the  price  of  young-child  formulae  is  very  similar  or  slightly  lower  than  that  of  infant 
formulae or follow-on formulae (it was underlined that in France the price tends to decrease 
with  age,  namely  that  infant formulae are slightly  more expensive than follow-on formulae, 
that are slightly more expensive than young-child formulae). Young-child formulae are also 
more expensive than cow's milk. By way of comparison, 1 litre of whole cow's milk in Spain 
(based on Eurostat data40) cost in 2012 on average €0.77. Considering that around 140 g of 
powdered product are needed to reconstitute 1 litre of young-child formulae41, and using the 

37 
38 

39 
40 

41 

AINIA (2013), p. 34. 
European  Natural  Soyfoods  Manufacturers  Association  (ENSA),  2014,  Reply  to  the  questionnaire  on 
young-child  formulae;  Secteur  Français  des  Aliments  de  l'Enfance  (SFAE),  2014,  Reply  to  the 
questionnaire on young-child formulae. 
Different national competent authorities, 2014, Reply to the questionnaire on young-child formulae.  
Eurostat, 2013, Detailed average prices report (2012),  
http://ec.europa.eu/eurostat/documents/272892/272992/Consumer_Prices_Research_2013.pdf/0effc4ed-
134c-4af4-a401-1a72fc74db8c 
Based on amounts generally recommended by manufacturers. 

17 

 
 
 
 
 
                                                 
 
reported price per kg by AINIA42, this would mean that an equivalent amount of reconstituted 
young-child formula cost at least €1.05 (36.4% more expensive th an cow's milk). Similarly, 1 
litre of whole cow's milk in the Netherlands (based on Eurostat data) cost in 2012 on average 
€0.88.  Based  on  the  same  assumptions,  1  litre  of  reconstituted  young-child  formulae  would 
cost at least €1.75 (98.9% more  expensive than cow's milk)43. 

Young-child formulae are distributed through different channels: retailers, specialised stores, 
websites  and,  in  a  more  limited  number  of  cases,  pharmacies.  Member  States  tend  to  agree 
that  when  formulae  are  sold  in  pharmacies,  prices  tend  to  be  slightly  higher  than  in 
supermarkets. It has also been reported by many Member States that the price of young-child 
formulae sold on the Internet is, in general, similar to that of formulae sold in super-markets 
(and  in  certain  cases  slightly  lower)44.  "Organic"  young-child  formulae  or  young-child 
formulae made from goat's milk protein are reported by some NGOs to be sold with a price 
premium45.  The  price  of  soy-based  young-child  formulae  is  reported  to  be  similar  to  other 
young-child formulae46.  

3.3.4.  Structure of the market of young-child formulae 

The market of young-child formulae is divided among a small number of players, with limited 
space for other actors. By way of example, in the UK, in 2012, the two companies with the 
largest share of the market occupied 96.5% of the retail market share by volume. Similarly, in 
France  in  the  same  year,  the  four  companies  with  the  largest  share  of  the  market  occupied 
82.8%  of  the  market  and  in  Germany  the  three  companies  with  the  largest  share  occupied 
98.6% of the market47. These companies are, in most cases, multinational companies selling 
their products in different Member States. Figures 5, 6 and 7 below provide a more detailed 
account of the situation in these three Member States. 

42 

43 

44 
45 

46 
47 

On the basis of AINIA data, the price per kg of young-child formulae in Spain is reported to be in the 
range  €7.5-10  per  kg.  The  lowest  value  in  the  range  (€7.5)  is  used  here  for  calculation  purposes.  This 
value is an estimation as it is based on prices reported by AINIA that represent the totality of the sector 
and do not distinguish between liquid and powder form. 
On the basis of AINIA data, the price per kg of young-child formulae in the Netherlands is reported to be 
in the range €12.5-15 per kg. The lowest value in the range (€12.5) is used here for calculation purposes. 
This value is an estimation as it is based on prices  reported by AINIA that represent the totality of the 
sector and do not distinguish between liquid and powder form. 
Different national competent authorities (2014). 
The International Baby Food Action Network (IBFAN), 2014, Reply to the questionnaire on young-child 
formulae (IBFAN's contribution also represents the position of the Baby Feeding Law Group); First Steps 
Nutrition Trust (2014). 
ENSA (2014). 
AINIA (2013).  

18 

 
 
                                                 
 Figure 5 – Market share by company in the UK – 2012 (source: AINIA data) 

Market share (UK)

0

3,50%

18,90%

0

Groupe Danone S.
A.

Pfizer, Inc.

Nestlé S. A. 

Own Label

77,60%

Others

Figure 6 – Market share by company in FR- 2012 (source: AINIA data) 

Market share (France)

13,50%

1,60%

Groupe Danone S. A.

2,10%

10,10%

17,70%

21,80%

Sodiaal

33,20%

Groupe Lactalis

Nestlé S.A. 

Hipp GmbH & Co. Vertrieb
KG.

Own label

Others 

19 

 
 
 
 
 
 
 
 
 
 
Figure 7 – Market share by company in Germany – 2012 (source: AINIA data) 

Market share (Germany)

1,30%

13,90%

25,60%

Nestlé S.A.

Groupe Danone S.A.

HiPP GmbH & Co.
Vertrieb KG.

59,10%

Others

It  has  been  reported48  that  young-child  formulae  are  manufactured  in  a  limited  number  of 
Member States (e.g. ES, BE, DE, NL, FR) and Switzerland and then traded to the rest of the 
EU  and  outside  the  EU.  Data  from  France  show  that  around  two  thirds  of  volumes  are 
produced  for  export  (out  of  this,  one  third  is  exported  to  other  EU  Member  States  and  two 
thirds to third countries). France exports three times more than the volume of imports. 

3.4. The marketing of young-child formulae 

As  explained  in  Chapter  1  of  this  SWD,  the  Commission  has  carried  out  extensive 
consultation with Member States and interested parties in preparation for the report on young-
child formulae.  The results  of  this  consultation have made it possible to identify a series of 
different aspects related to the marketing of young-child formulae in the EU.  

Sales denomination: the denomination most commonly used to market young-child formulae 
in the different EU Member States is "growing-up milk". "Toddlers' milk" is also commonly 
used, as well as "junior milk"/"junior drink", "milk based drink for young children"49 or "milk 
drink  for  toddlers".  It  has  been  reported  that  the  product  is  sometimes  called  "follow-on 
formula from 12 months"50. In case of soy-based products, the denomination used is "growing 
up drinks" or "soy drinks for children between 1-3 years with added minerals and vitamins"51. 
In the case of young-child formulae made from goat's milk protein, the denomination used is 
sometimes "milk based food based on powder goat milk for young child above 1 year"52. 

Use  of  claims  /  other  statements:  the  marketing  of  young-child  formulae  is  based  on  the 
product's  specific  formulation.  Operators  market  young-child  formulae  as  products  with  a 
specific formulation for the nutritional needs of young children. In this context, a variety of 
nutrition  claims  are  often  used  that  describe  the  products'  particular  nutritional  properties. 
These  nutrition  claims  are,  for  example,  related  to  ingredients  that  are  added  to  the  product 
and  that  are  considered  beneficial  for  young  children  (e.g.  "contains  vitamin  D"  or  "with 
iron",  "added  omega-3"),  or  to  nutrients  that  the  products  contain  in  reduced  proportion,  so 

48 
49 
50 
51 
52 

Different national competent authorities (2014); SFAE (2014). 
This is also the sales denomination in French law for the product. 
Sweden, 2014, Reply to the questionnaire on young-child formulae.  
ENSA (2014); Belgium (2014). 
Belgium (2014).  

20 

 
 
 
                                                 
that it is more suitable for young children (e.g. "contains less saturated fats than cow's milk", 
"reduced protein", "protein content adapted to the needs of young children").  

Specific health claims on the role of the different ingredients are also made (e.g. "calcium and 
vitamin  D  are  needed  for  normal  growth  and  development  of  bone  in  children"  or  "iron 
contributes  to  normal  cognitive  development  of  children"),  as  well  as  generic  statements  on 
the  role/suitability  of  the  products  in  contributing  to  healthy  growth  of  young  children. 
Special emphasis is, in particular, put on certain nutrients present in the products (e.g. iron, 
vitamin D) that are considered critical for young children (because intake through the diet is 
commonly reported as inadequate or nutrient status is low). 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.  Two 
NGOs reported that young-child formulae are shown as a "nutritional safety net" for parents53, 
and  nutritional  superiority  to  cow's  milk  is  often  used  as  a  marketing  argument  (e.g. 
"nutritionally superior to cow's milk", "contains 40 times more iron than cow's milk"). Certain 
brands focus on the "organic" nature of the product.  

Use of images: images of young children or, most often, imaginary characters or animals (e.g. 
teddy  bears,  giraffes,  rabbits  and  elephants)  are  present  on  the  label/advertising  of  the 
products.  When  images  of  young  children  are  used,  the  young  children  are  represented  as 
standing on their own feet in order to represent children older than one year of age (in cases of 
products  targeted  for  young  children  older  than  two  years  the  young  child  is  sometimes 
represented  as  more  active/walking).  In  the  case  of  young-child  formulae  made  from  goat's 
milk protein, pictures of goats are often used. Finally images of families are sometimes used.   

Statements  on  the  superiority  of  breastfeeding/recommendations  on  a  balanced  diet: 
statements on the superiority of breastfeeding are reported to be used, in certain cases, on a 
voluntary  basis,  and  appear  on  the  labelling/advertising  of  products  (e.g.  on  Internet 
websites). More often, products bear statements recommending that young-child formulae are 
consumed as part of a varied, balanced diet. The products are also marketed with statements 
on the suitable age for consumption and, sometimes, with statements indicating that they are 
not suitable for infants under 6 or 12 months.  

Targeted age range and differences in composition: young-child formulae are developed and 
marketed for young children aged 1-3 years or, in certain cases, for narrower sub-groups, the 
most  common  being  1-2  years  and  2-3  years.  It  has  been  reported  that  the  products  are 
sometimes marketed as suitable from 10 months on or from 15 months on54.   

When  an  operator  develops  different  products  for  different  age-related  sub-groups,  the 
composition varies. The main differences have been reported to be in the amount of energy 
and macro-nutrients. Products for the age range 2-3 years normally contain a lower level of 
energy, fat, protein and carbohydrates than those for the age range 1-2 years. With respect to 
micronutrients, some Member States reported that lower levels of micronutrients are present 
in  products  for  older  young  children,  although  the  difference  is  sometimes  only  minor55. 
Another  Member  State56  reported  that  higher  levels  of  micronutrients  can  be  present  in 

53 
54 

55 

56 

First Steps Nutrition Trust (2014); IBFAN (2014). 
It is reported that sometimes the product is marketed for children older than 3 years. This is however out 
of the scope of the report that covers only milk-based drink intended for young children. 
Czech  Republic,  2014,  Reply  to  the  questionnaire  on  young-child  formulae;  United  Kingdom,  2014, 
Reply to the questionnaire on young-child formulae. This was confirmed by First Steps Nutrition Trust 
and IBFAN in their contribution to the questionnaire on young-child formulae (2014). 
Ireland, 2014, Reply to the questionnaire on young-child formulae. 

21 

 
 
                                                 
products  for  older  young  children.  In  this  context,  the  association  representing  French 
producers  (Syndicat  Français  des  Aliments  de  l’Enfance,  SFAE)  explained  that  the 
composition of formulae targeting young children 2-3 years old tends to fit to the local dietary 
habits, taking into account the reduction in milk consumption in older young children. As a 
result, the formulae might be more concentrated in certain nutrients57. 

Distinction from infant and follow-on formulae: the distinction between young-child formulae 
and  infant  formulae  and  follow-on  formulae  is  ensured  by  the  product  denomination  (e.g. 
"growing-up milk", "toddlers' milk"), by an indication on the label of the age range for which 
the product is intended (e.g. "+1"), by the use of a numbering system based on the concept of 
staging (1 for infant formulae, 2 for follow-on formulae, 3 and 4 for young-child formulae58) 
and/or by the use of different colours/design on the labels.  

Some  Member  States  and  NGOs,  however,  underlined  that  the  distinction  between  young-
child formulae and infant formulae and follow-on formulae is, in certain cases, difficult, due 
to the strong similarities in the packaging between products of the same brand, and requires a 
careful  reading  of  the  product  label59.  It  was  also  noted  by  one  Member  State  that  the 
similarities  in  the  branding  between  infant  and  follow-on  formulae  on  one  side  and  young-
child formulae on the other, coupled with the fact that the products are presented next to each 
other,  in  the  same  area  of  shops,  can  give  the  message  to  consumers  that  young-child 
formulae are a logical consequence/necessity after one year of age60. During the meeting of 
the Working Group of the Advisory Group on the Food Chain and Animal and Plant Health of 
19  September  2014,  the  representative  of  IBFAN  (also  on  behalf  of  the  Baby  Feeding  Law 
Group) underlined that similarities in the branding of young-child formulae and formulae for 
infants have an impact on breastfeeding rates for infants and on wrong consumption of young-
child formulae before one year of age. 

Specific sub-groups of the population with particular conditions: as it was confirmed by one 
stakeholder61, young-child formulae are developed for young children in good health but who 
may  have  inadequate  dietary  intakes  or  be  at  risk  of  inadequate  nutritional  status.  As  such, 
young-child  formulae  are  not  developed  for  specific  sub-groups  of  the  young-children 
population  with  particular  conditions.  However,  it  has  been  reported  that  young-child 
formulae  targeting  lactose  intolerant  consumers  are  on  the  market  in  different  EU  Member 
States.  These  products  are  lactose-free  (either  because  they  have  been  processed  to  remove 
the lactose content or because they are naturally lactose-free) and are normally targeting the 
age range 1-3 years.   

57 
58 

59 

60 
61 

SFAE (2014).  
From the information received, it appears, however, that the numbers 3 and 4 are not used consistently. In 
certain  cases,  number  3  stands  for  products  intended  for  infants  after  10  months,  and  number  4  for 
products  intended  for  young  children  after  15  months;  in  other  cases,  number  3  stands  for  products 
intended for young children after 12 months, and number 4 for products intended for young children after 
24 months. 
Slovakia,  2014,  Reply  to  the  questionnaire  on  young-child  formulae;  Austria,  2014,  Reply  to  the 
questionnaire on young-child formulae; UK (2014); IBFAN (2014); First Steps Nutrition Trust (2014). 
Croatia, 2014, Reply to the questionnaire on young-child formulae. 
SNE (2014). 

22 

 
 
 
                                                 
4.  CONSUMER'S PERCEPTION AND BEHAVIOUR 

This Chapter describes different aspects related to the behaviour of consumers of young-child 
formulae62. It focuses on consumption patterns of young children, analysing intakes of young-
child  formulae,  as  well  as  of  other  protein-rich  liquid  drinks  that  can  form  part  of  young 
children's  diet  (e.g.  breast  milk,  cow's  milk).  It  describes  parents'  and  other  caregivers' 
perception of young-child formulae, trying to address the question of why are these products 
consumed  (or  not  consumed)  by  young  children.  It  also  focuses  on  the  role  of 
recommendations of health care professionals and national authorities, as these are powerful 
factors influencing parents' and caregivers' behaviour when it comes to young-child formulae.  

In  this  context,  it  should  be  noted  that  young  children's  feeding  practices  vary  significantly 
throughout the EU, taking into account social, economic and cultural differences, differences 
in  the  recommendations  from  health  care  professionals  and  national  authorities  and  product 
availability. For this reason, no study exists reporting on intakes of breast milk, cow's milk, 
milk-based  drinks  and  similar  products  in  the  diet  of  young  children  throughout  the  EU. 
Similarly  no  single  study  reports  on  parents  and  other  caregivers'  perception,  behaviour, 
interest,  understanding  and  preference  with  respect  to  young-child  formulae  throughout  the 
EU. 

For the purposes of the report, three Member States will be analysed in depth in the following 
sections. These Member States have been identified as sufficiently representative of the EU in 
terms of market size, differences in feeding practices and recommendations from health care 
professionals  and  national  authorities.  A  conclusive  paragraph  summarizes  the  situation  for 
the overall EU, based on the submissions of Member States and interested parties. 

4.1. United Kingdom 

4.1.1.  Consumption data 

Relevant consumption data for young children in the UK can be obtained from the Diet and 
Nutrition Survey of Infants and Young Children (2011) and the National Diet and Nutrition 
Survey (2008/09 – 2011/12). 

The  Diet  and  Nutrition  Survey  of  Infants  and  Young  children  was  commissioned  by  the 
Department of Health and the Food Standards Agency to provide detailed information on the 
food consumption, nutrient intakes and nutritional status of infants and young children aged 4 
up to 18 months living in private households in the UK. The survey was carried out in 2011 in 
all four countries of the UK, and was designed to be representative of the UK population. The 
survey report was published in March 201363.  
Data  from  the  survey64,  represented  in  Table  5  below,  show  that  the  proportion  of  young 
children aged 12 to 18 months being still breastfed amounted to 8% with an estimated mean 
volume  of  290  g/day.  1%  were  still  given  "first  milk"  formula,  1%  "hungrier  baby  milk" 
formula, 16% "follow-on milk" formula and 3% "other milk products". 18% of children in the 
age range were given "growing-up milk" formulae, with a mean intake of 342 g/day. 79% of 
the respondents were given whole milk with a mean intake of 329 g/day (amounts similar to 

62 

63 

64 

Depending  on  the  context,  the  word  "consumer"  can  refer  either  to  young  children  or  to  parents  and 
caregivers and their role in young children's nutrition. 
Lennox A, Sommerville J, Ong K., Henderson H. and Allen R. (Eds), 2013, Diet and Nutrition Survey of 
Infants and Young Children, 2011. 
Lennox A, Sommerville J, Ong K., Henderson H. and Allen R (2013), Table 6.2. The terminology used is 
that of the survey. 

23 

 
 
                                                 
those of "growing up milks"). According to the survey, young-child formulae were also used 
by 3% of families with children aged 10-11 months with a mean intake of 397 g/day65. 
Table 5 - Total quantities of food consumed (grams) per day: consumers66 only, 12-18 months (source: Diet and 
Nutrition Survey of Infants and Young Children 2011) 

Food group 

Mean 

Median 

% consumers67 

Whole milk (3.8% fat) 

Semi skimmed milk (1.8% fat) 
Other milk and cream68 
Water 

'First milk' 

'Hungrier babies milk' 

Follow-on milk 

'Growing up milk' 

Soy milk 
Other milk products69 
Breast milk 

329 

169 

75 

143 

389 

350 

323 

342 

373 

387 

290 

341 

52 

15 

109 

394 

336 

311 

343 

308 

405 

230 

79 

13 

10 

76 

1 

1 

16 

18 

0 

3 

8 

The National Diet and Nutrition Survey was designed to assess the diet, nutrient intake and 
nutritional  status  of  the  general  population  aged  1.5  years  and  over,  living  in  private 
households in the UK. Jointly funded by Public Health England (PHE), an executive agency 
of the Department of Health, and the UK Food Standards Agency, the survey has been carried 
out in all four countries of the United Kingdom and is designed to be representative of the UK 
population.  Results  covering  the  first  four  years  of  the  rolling  programme  from  2008/09  to 
2011/12 were published in May 201470.  
Data from the survey71, represented in Table 6 below, show intakes and intake rates for milk 
and milk products and commercial foods for young children in the age range 18-36 months. 
The data are presented in a similar format to that of the Diet and Nutrition Survey of Infants 
and  Young  Children,  so  that  comparisons  can  be  made.  As  it  appears,  whole  cow's  milk  is 
consumed by a smaller percentage of respondents (64%) than in the age range 12-18 months. 
Amounts  consumed  are  also  reported  to  be  lower  (mean  of  280  g).  Consumption  of  semi 
skimmed milk picks up (43% of respondents, mean intakes of 192 g), while consumption of 
commercial toddler foods decreases significantly to 17% of respondents (mean consumption 
of 57 g). 

65 
66 
67 
68 
69 
70 

71 

Lennox A, Sommerville J, Ong K., Henderson H. and Allen R (2013), Table 6.2. 
Per cent consumers is over four days although the gram intake is per day. 
Small numbers of consumers are rounded down to zero.  
Includes 1% fat and skimmed milk. 
Includes hypoallergenic, goats and 'goodnight' milks. 
Bates B, Lennox A, Prentice A, Bates C, Page P, Nicholson S and Swan G (Eds), 2014, National Diet and 
Nutrition Survey: Results from Years 1, 2, 3 and 4 (combined) of the Rolling Programme (2008/2009 – 
2011/2012).  
Bates B, Lennox A, Prentice A, Bates C, Page P, Nicholson S and Swan G (2014), Table 5.2c. 

24 

 
 
                                                 
 
Table 6 - Total quantities of food consumed (grams) per day: consumers72 only, 18-36 months (source: National Diet and Nutrition 

Food group 
Whole milk (3.8% fat) 
Semi skimmed milk (1.8% fat) 
1% fat milk 
Skimmed milk (0.5% fat) 
Other milk and cream 
Commercial toddler foods 
Tea, coffee and water 

Mean 

Median 

% consum

280 
192 
214 
335 
205 
57 
228 

238 
144 
218 
200 
100 
25 
194 

64 
43 
0 
4 
22 
17 
81 

In brief, data from the surveys carried out in the UK show that breastfeeding rates are very 
low  after  one  year  of  age.  Cow's  milk  is  generally  consumed  for  the  entire  period  12-36 
months, but semi-skimmed milk is increasingly consumed with age. Consumption of formula 
products (part of the food group "commercial toddler food") decreases after 18 months. 

4.1.2.  Parents' and other caregivers' perception of young-child formulae 

An insight on parents' and other caregivers' perception of young-child formulae in the UK can 
be obtained from an online survey carried out by the consumer organisation Which? between 
8  November  and  6  December  2012.  The  survey  included  727  mothers  with  children  under 
three years old (478 of these had children between one and three). 

The  survey  showed  that:  “mothers  absorb  marketing  claims  about  the  benefits  of  added 
ingredients  in  milks  they  see  in  advertisements  and  marketing  material,  citing  these  as 
reasons why they use toddler milk. Top reasons for using these milks include: 

• 

• 

It was the next stage of formula so moved on automatically (46%) 

It has nutrients appropriate to development for this age (40%) 

•  Has more nutrients than cow’s milk (32%) 

•  Concerned that baby is not getting enough nutrients from food (27%). 

Which? also reported that: “parents will stick with the same brand when using follow-on and 
toddler  milks,  even  if  prices  rise.  When  originally  choosing  infant  formula,  parents  told  us 
trust and familiarity of the brand are two of the top three factors when choosing a formula 
milk, only surpassed by recommendation from a friend/family”73. 

4.1.3.  Recommendations of health care professionals and national authorities 

Survey information on health care professionals’ perception of formulae in the diet of young 
children  in  the  UK  is  not  available.  Similarly,  no  information  is  available  on  specific 
recommendations given by health care professionals in the UK on the intake of milk and/or 
formulae for young children.  

72 
73 

Per cent consumers is over the four days although the gram intake is per day. 
Which?, 2013, Toddler milks – a winning formula?, 
http://www.staticwhich.co.uk/documents/pdf/toddler-milks-a-winning-formula---which-report-
331142.pdf 

25 

 
 
 
                                                 
 
Useful  information  on  the  recommendations  given  by  national  authorities  in  the  UK  can  be 
obtained  from  the  website  NHS  Choice74,  which  provides  quick  to  read  advice  from  the 
government on health related issues.  

With respect to cow's milk and formula drinks in the diet of young children the website states: 
"from 12 months full-fat cows’ milk is fine as [young children's] main drink. Infant formula, 
follow-on formula or growing-up milk is not needed once your baby is 12 months old."  75 It 
also adds: "Cows’ milk doesn’t contain enough iron and other nutrients to meet young babies’ 
needs.  That's  why  it  shouldn’t  be  given  as  a  drink  to  babies  until  they  are  12  months  old. 
Whole milk should be given to children until  they  are two  years old, as they need the extra 
energy and vitamins it contains. Semi-skimmed milk can be introduced once your child is two 
years  old,  as  long  as  they're  a  good  eater  and  they  have  a  varied  diet.  Skimmed  and  1% 
milk are not suitable for children under five, as they don't contain enough calories. Lower-fat 
milks can be used in cooking from the age of one though"76. 

4.2. Germany 

4.2.1.  Consumption data 

No  up-to-date  representative  data  are  available  on  eating  habits  of  young  children  in 
Germany.  

A  partial  estimate  about  breastfeeding  rates  in  young  children  can  be  derived  from  a 
nationwide breastfeeding survey, which included 1 717 mother-child-pairs, but was conducted 
more  than  15  years  ago,  in  1997/9877.  This  survey  showed  that  the  rate  of  breastfeeding 
mothers  (breastfeeding  combined  with  complementary  feeding  and,  in  certain  cases, 
formulae) at 12 months of age amounted to 13%. No data on frequency and volumes of intake 
of formula products were collected in this study. 

Data  on  volumes  of  breast  milk,  formula  products  and  cow's  milk  consumed  can  be  drawn 
from  a  nationwide  survey  on  food  consumption  of  infants  and  young  children,  which  was 
conducted in 2001/02 in order to estimate the long and short-term dietary intake of pesticide 
residues (VELS Study) 78.  Data from the VELS study are shown below in Table 779. 

Estimates  of  intakes  of  breast  milk,  formula  products  and  cow's  milk  consumed  by  young 
children  in  Germany  can  also  be  drawn  from  data  collected  in  the  German  Dortmund 
Nutritional and Anthropometric Longitudinally Designed (DONALD) study. The DONALD 
study,  launched  in  1985  by  the  Research  Institute  of  Child  Nutrition  in  Dortmund,  is  a 
longitudinal  (open  cohort)  study  collecting  detailed  data  on  diet,  growth,  development  and 

74 
75 

76 

77 

78 

79 

http://www.nhs.uk/Pages/HomePage.aspx 
http://www.nhs.uk/Conditions/pregnancy-and-baby/Pages/help-baby-enjoy-
foods.aspx?tabname=Getting%20pregnant 
http://www.nhs.uk/conditions/pregnancy-and-baby/pages/drinks-and-cups-
children.aspx?tabname=Labour%20and%20birth 
Kersting M, Dulon M, 2002, Assessment of breast-feeding promotion in hospitals and follow-up survey of 
mother-infant pairs in Germany: the SuSe Study. Public health nutrition, Aug;5(4):547–552.  
Verzehrsstudie  zur  Ermittlung  der  Lebensmittelaufnahme  von  Säuglingen  und  Kleinkindern  für  die 
Abschätzung eines akuten Toxizitätsrisikos durch Rückstände von Pflanzenschutzmitteln. 
Forschungsinstitut  für  Kinderernährung  Dortmund (FKE), 2003,  Ernährungsphysiologische  Auswertung 
einer  repräsentativen  Verzehrsstudie  bei  Säuglingen  und  Kleinkindern  VELS  mit  dem  Instrumentarium 
der DONALD Studie, Schlussbericht. 

26 

 
 
                                                 
metabolism between infancy and adulthood. Data from the DONALD study are shown below 
in Table 880. 

Both the VELS and the DONALD study show that young children beyond the age of 1 year 
consume  very  low  amounts  of  breast  milk  and  rather  small  amounts  of  formula  products81. 
Also,  both  studies  show  that  these  intakes  decrease  with  age.  Both  studies  also  show  that 
intakes  of  milk  and  milk  products  remain  high  in  the  age  range  1-3  years  with  minor 
fluctuations in intakes.  

Table 7 – Mean intakes of different foods (gram per day) at different ages and divided by sex (source: VELS study) 

Food 

Mean intakes (at different age and per sex) 

Breast milk (g/d) 
Formula products (g/d) 
Milk and milk products (g/d) 

1 year 

2 years 

3 years 

Male 
15.7 
43.6 
289.9 

Female 
18.6 
81.5 
228.1 

Male 
0 
19.5 
303.0 

Female 
0 
13.4 
274.3 

Male 
0 
16.2 
274.9 

Female 
0 
0.1 
259.5 

Table 8 – Mean intakes of different foods (gram per day) at different ages (source: Hilbig) 

Food 

Mean intakes (at different ages) 

Breast milk (g/d) 
Formula products (g/d) 
Milk and milk products (g/d) 

12 months 
12.9 
146.1 
244.1 

18 months 
0.9 
41.2 
340.2 

24 months 
0.4 
19.9 
326.8 

36 months 
0 
13.4 
316.8 

Other relevant data can be obtained from an analysis of dietary records from the DONALD 
study  for  the  period  1986-200182.  The  data,  shown  in  Figure  8  below,  reveal  that  young 
children  aged  1  to  3  years  have  been  consuming  similar  total  amounts  of  milk  and  formula 
over the years (approximately 300 g per day). However, the proportion coming from formula 
compared to milk has started to shift, with a larger proportion of the gram intake coming from 
formula,  which  can  suggest  that  formula  products  are  replacing  cows’  milk  in  the  diets  of 
young children in Germany. 

80 

81 

82 

Hilbig A, 2005 Längerfristige Trends bei der Ernährung von Säuglingen und Kleinkindern der DONALD 
Studie im Zeitraum 1989 – 1999.  
It should however be taken into account that when the data for these two analyses were collected, young-
child formulae in the form as they exist today were not on the market in Germany. 
Alexy  U,  Kersting  M,  2003,  Time  trends  in  the  consumption  of  dairy  foods  in  German  children  and 
adolescents, European Journal of Clinical Nutrition, 57, 1331-1337. 

27 

 
 
 
 
 
                                                 
Figure 8 - Time trends of ‘milk products’ and ‘formula’ intake in 1–3-y-old participants of the DONALD Study 
1986–2001 (source: Alexy and Kersting on the basis of data from the DONALD study) 

These conclusions are also supported by a more recent analysis of the dietary records from the 
DONALD study for the period 2005-2008 which revealed that an increasing number of young 
children  consumed  formula  products  as  an  alternative  to  cows'  milk83.  When  looking  more 
carefully into the data, this recent analysis also shows that the proportion of young children 
consuming formula products with an adapted protein content decreases rapidly from 90% at 
the age of 9 months to just 3% at the age of 36 months. As a comparison, the percentage of 
those children consuming cows' milk and cows' milk products significantly increases.  

In brief, data from surveys carried out in Germany show that breast milk consumption is very 
low after one year (both in term of rates and intakes). Intakes of formula products in young 
children  in  Germany  are  relatively  low,  and  decrease  with  age.  Consumption  of  cow's  milk 
remains on the contrary predominant. Recent data show however that an increasing number of 
young children are consuming formula products (as an alternative to cow milk). 

4.2.2.  Parents' and other caregivers' perception of young-child formulae 

The German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, BfR) 
carried  out  a  survey  in  2011  on  consumers'  perception  of  young-child  formulae84, 
interviewing 853 caregivers of young children and dividing them into two groups depending 
on whether they were used to purchase young-child formulae or cow's milk.  
Figure 9 below85 shows the main reasons given by respondents to the question "why are you 
buying young-child formula?".  

83 

84 

85 

Alexy  U,  Kersting  M,  2010,  DONALD  News  Kindermilch  oder  Kuhmilch  in  der  Kleinkindernährung, 
Ernährungs Umschau,  8: 405. 
Tilgner A, Ehlers A, Röder B, Martin A, Weißenborn A, 2013, What drives parents to buy toddler milk?, 
Ernaehrungs Umschau international, 60(7): 116–123. For more details refer to the final report from BfR 
on young-child formulae: Bundesinstitut für Risikobewertung, 2014, Kindermilch – Abschlussbericht. 
Tilgner A, Ehlers A, Röder B, Martin A, Weißenborn A, (2013). 

28 

 
 
 
                                                 
Figure 9 – Main reasons for purchasing young-child formulae (source: Tilgner et al.) 

The  most  common  answers  selected  by  respondents  were  health  reasons,  including  allergy 
avoidance, the better tolerance in comparison to cow’s milk, as well as the product's specific 
composition.  Other answers  provided referred to recommendations, taste, advertising offers, 
special quality seals and claims made by the manufacturers. 

Participants who could remember specific claims made on the products mostly recalled claims 
related  to  the  vitamin  and  mineral  content,  the  good  tolerance  of  the  products  and  claims 
related to the superiority of young-child formula  when  compared  to  cow’s  milk.  About  two 
thirds of the purchasers of young-child formulae preferred the products in powder form and 
regarded the longer shelf-life of the powder as an important advantage relative to cow’s milk. 
16% of the purchasers also saw disadvantages for toddler milk when compared to cow’s milk, 
the most important being the higher price86. 

When  asked  how  they  became  aware  of  young-child  formulae  for  the  first  time,  30.4%  of 
respondents indicated that information was obtained in retailers/supermarket. 20.5% indicated 
family members and acquaintances and 13.7% a midwife. 13.2% referred to advertising in the 
media, 11.5% to a doctor87.  

In brief, the survey shows that caregivers receive information on young-child formulae from 
different sources, including operators. Only a limited number of respondents became aware of 
the product following health care professionals' advice. 

4.2.3.  Recommendations of health care professionals and national authorities 

The BfR adopted in 2014 a report on young-child formulae. The report concludes that after 
the  age  of  1  year,  in  general,  there  is  no  nutritional  necessity  for  specific  foods  and  it  is 
desirable that young children adapt to a diversified diet with fresh ingredients consumed by 
the  family.  The  BfR  also  notes  that  young-child  formulae  can  increase  the  supply  of 
micronutrients  in  young  children,  but  are  not  better  suitable  for  these  purposes  than  other 
fortified  foods  or  the  early  introduction  of  meat  or  fish  in  the  diet  of  young  children.  The 
report  concludes  that  families  should  receive  information  explaining  the  importance  of 

86 
87 

Tilgner A, Ehlers A, Röder B, Martin A, Weißenborn A, (2013). 
BfR (2014), p. 12. 

29 

 
 
 
                                                 
ensuring  that  young  children  taking  part  in  the  family  diet  receive  a  diversified  diet,  that 
young-child formulae are unnecessary from a nutritional point of view and that their extensive 
consumption might lead to excess intakes of certain nutrients88.    

Considerations  on  young-child  formulae  are  also  provided  in  the  recommendations  on 
nutrition and  physical activity  for  children 1–3 years old from the network "Healthy start – 
Young child family network". This is a project of the Federal Government with the support of 
leading  institutions,  professional  societies  and  associations,  which  aims  to  develop 
harmonised  recommendations  for  actions  in  the  field  of  nutrition  and  physical  activity89.  In 
the  document  it  is  explained  that  cows'  milk  is  useful  food  for  young  children  and  that 
"special milk drinks" are in principle not necessary for a balanced diet of young children. The 
recommendations go beyond this statement and underline that if young-child formulae are to 
be used, preference should be given to those products that comply with the recommendations 
of the German Society of Paediatrics and Adolescent Medicine (DGKJ). 
The DGKJ adopted updated guidance90 on young child-formulae in 2011. In this document, 
DGKJ recalls that young-child formulae are in principle not necessary and that young children 
should  consume  1/3  litre  of  cow's  milk  (preferably  with  a  fat  content  of  1.5%)  and  milk 
products  per  day  as  part  of  a  balanced  diet  (vitamin  D  fortification  of  milk  is 
recommendable).  It  then  recommends  specific  compositional  requirements  for  young-child 
formulae  if  they  are  used  in  place  of  cow's  milk:  it  is  recommended  that  the  nutritional 
composition of young-child formulae is similar to whole cow's milk regarding nutrients such 
as  calcium,  vitamins  A  and  riboflavin  and  similar  to  low-fat  cow's  milk  regarding  energy 
content. The content of critical nutrients such as iodine and vitamin D should be in line with 
that  laid  down  in  Directive  2006/141/EC  on  infant  formulae  and  follow-on  formulae. 
Flavouring and sweetening agents should not be added.   

88 
89 

90 

BfR (2014) p.45. 
Koletzko  B,  Armbruster  M,  Bauer  C-P  et  al.,  2013,  Ernährung  und  Bewegung  im  Kleinkindalter 
Handlungsempfehlungen des Netzwerks „Gesund ins Leben – Netzwerk Junge Familie“, ein Projekt von 
IN FORM, Monatsschrift Kinderheilkunde, 12. 
Ernährungskommission der Deutschen Gesellschaft für Kinder- und Jugendmedizin e.V. (DGKJ)  (Böhles 
HJ, Fusch C, Genzel-Boroviczén O, Jochum F, Kauth T, Kersting M, Koletzko B, Lentze MJ, Mihatsch 
WA,  Przyrembel  H,  Wabitsch  M),  2011,  Zusammensetzung  und  Gebrauch  von  Milchgetränken  für 
Kleinkinder  Aktualisierte  Empfehlungen  der  Ernährungskommission  der  Deutschen  Gesellschaft  für 
Kinder- und Jugendmedizin (DGKJ), Monatsschrift Kinderheilkunde, 10, 159:981–984. 

30 

 
 
                                                 
4.3. France 

4.3.1.  Consumption data 

Relevant consumption data for France can be obtained from the NutriBébé Survey, carried out 
in 2013 by TNS Sofres on behalf of the French formulae manufacturers' association (SFAE). 
SFAE  has  been  requesting  every  eight  years  since  1981  a  national  survey  on  feeding 
behaviour and consumption in children under 3 years old. The 2013 survey was carried out on 
1 188  mothers  of  infants  and  young  children  representative  of  the  French  population91  and 
was divided in two parts: the first one describing caregivers' behaviour and the second one the 
nutritional intakes. 

Table  9  below  summarizes  the  outcome  of  the  2013  survey  with  respect  to  consumption  of 
breast milk, formula products and cow's milk in young children, taking into account different 
age ranges. As it appears, rates of consumption of breast milk are very low after one year of 
age.  Consumption  of  young-child  formula  is  at  its  peak  in  the  age  range  12-17  months  and 
tends to decrease afterwards, while consumption of cow's milk increases and reaches its peak 
in the age range 30-35 months.  

Table  9  –  Consumption  rates  of  breast  milk,  formula  products  and  cow's  milk  as  a  percentage  of  the  sample 
(source: NutriBébé survey 2013) 

Food 

Rate of consumption (at different ages) 

Breast milk (%) 
Infant Formula (%) 
Follow-on formula (%) 
Young child formula (%) 
Cow's milk (%) 

12-17 months 
6 
0 
2 
53 
33 

18-23 months 
9 
0 
4 
47 
35 

24-29 months  
2 
0 
0 
31 
64 

30-35 months  
0 
0 
0 
24 
73 

Table  10  below  summarizes  the  outcome  of  the  2013  survey  with  respect  to  intakes  of 
formula products and cow's milk in young children, taking into account different age ranges. 
As  it  appears,  intakes  of  formula  products  decrease  with  age,  while  intakes  of  cows'  milk 
increase (taking the largest part at 24 months). 

Table 10 – Intakes of formula products and cow's milk (grams) (source: NutriBébé survey 2013) 

Food 

Intakes (at different ages) 

Infant Formula (g) 
Follow-on formula (g) 
Young child formula (g) 
Cow's milk (g) 

12-17 months 
4.2 
23.3 
233.3 
164.6 

18-23 months 
2.5 
20.5 
221.9 
152.4 

24-29 months  
0 
2.6 
119.4 
213.0 

30-35 months  
0 
0 
68.0 
209.8 

91 

Detailed  analysis  of  the  results  of  the  NutriBébé  survey  are  starting  to  be  published  (see  in  particular 
Tavoularis G, 2015, Enquête Nutri-Bébé 2013 Partie 1. Présentation et considérations méthodologiques, 
Archives de  Pediatrie,  22  (10),  Supplement  1,  10S1–10S6  and  Bocquet  A,  Vidailhet  M,  2015,  Enquête 
Nutri-Bébé  2013  Partie  2.  Comment  les  mères  nourrissent-elles  leur  enfant?  Archives  de  Pediatrie,  22 
(10),  Supplement  1,  10S7–10S19). Data  covered  in  this Chapter have been  taken  from  the  publications 
above and integrated by: SFAE, 2014, "Que révèle l'enquete NutriBébé 2013?", le Pédiatre, 262, XLX; 
at: 
the 
SFAE 
on 
http://www.secteurfrancaisdesalimentsdelenfance.com/comment-sont-nourris-nos-bebes-en-2013/; 
the 
replies from France and SFAE to the questionnaire on young-child formulae (2014) and additional data 
that SFAE shared with the Commission on the results of the NutriBébé survey. 

accessible 

package 

website 

press 

the 

of 

31 

 
 
 
 
 
 
                                                 
Other data from the survey show that the percentage of mothers giving young-child formulae 
to  their  children  is  higher  among  mothers  who  are  still  breastfeeding  or  used  to  breastfeed 
(32%) than among  mothers who did not breastfeed (25%). On the contrary, consumption of 
cow's  milk  is  higher  among  non-breastfeeding  mothers  (48%)  than  among  mothers  who 
breastfed their babies at some point (31%). The preferred type of cow's milk is semi-skimmed 
milk (88% of caregivers in 2013) which is by far more consumed than whole cow's milk (12% 
in 2013). 76% of caregivers have a preference for normal cow's milk while 21% are interested 
in milk fortified with different vitamins (main one being vitamin D). 

Table 11 below summarizes the outcome of the previous survey, carried out for SFAE in 2005 
on  713  infants  and  young  children92.  As  it  appears,  similar  trends  were  already  present,  in 
particular with respect to the decrease in rates of consumption of young-child formulae  and 
increase  in  consumption  of  cow's  milk.  Full  comparability  between  the  studies  of  2005  and 
2013 cannot however be ensured because of the minor differences in the age range, and the 
fact that the 2005 survey was carried out on non-breastfeeding mothers only, so that no data 
exist on intakes of breast milk. 

Table  11  –  Consumption  rates  of  formula  products  and  cow's  milk  as  a  percentage  of  the  sample  (source: 
NutriBébé survey 2005) 

Food 

Rate of consumption (at different ages) 

Infant Formula (%) 
Follow-on formula (%) 
Young child formula (%) 
Cow's milk (%) 

13-18 months 
0 
9 
52 
34 

19-24 months 
0 
0 
27 
69 

25-30 months 
0 
0 
26 
73 

30-36 months 
0 
0 
8 
87 

In  brief,  data  from  France  confirm  trends  identified  in  Germany  and  the  UK,  whereby 
breastfeeding  is  low  after  one  year.  Young-child  formulae  consumption  is  at  its  peak  in  the 
period 12-18 months and decreases afterwards, replaced by consumption of cow's milk. These 
trends have been stable in the last 8 years. 

4.3.2.  Parents' and other caregivers' perception of young-child formulae 

The survey carried out for SFAE in 2013 also provides useful information on the perception 
of  caregivers  with  respect  to  young-child  formulae.  Figure  10  below  summarises  the  main 
reasons  given  by  respondents  to  the  question  "why  are  you  passing  on  to  young-child 
formula?".  

92 

Turberg-Romain  C,  Lelievre  B,  Le  Heuzey  M-F,  2007,  Evolution  of  feeding  behaviours  in  mothers  of 
infants and young children from 1 to 36 months old in France, Archives de Pediatrie, 14(10), 1250–1258. 

32 

 
 
 
 
                                                 
Figure 10 – Answers given to the question "why are you passing on to young-child formula?" (as a percentage of 
the sample (multiple answers were possible)) (source: NutriBébé survey) 

It better suits the nutritional needs of my child

My child had the right age to consume it

It is better adapted than cow's milk

It contains Iron

It is good for the health of my child

It was recommended to me

It contains Vitamin D

53%

48%

39%

38%

38%

37%

32%

I already gave it to another child

27%

Its protein content is adapted to the needs of my child

It contains essential fatty acids

It is good value for money

4%

23%

21%

As  it  appears,  the  most  frequent  answers  relate  to  the  better  suitability  of  young-child 
formulae to the nutritional needs of young children, to the fact that the young child had the 
right age to consume the product, to the superiority of the product when compared to cow's 
milk, to its iron content, to its positive impact on the health of young children and to the fact 
that the product was recommended by someone. Only 4% of respondents found the product to 
be good value for money. 

As  in  the  case  of  the  UK  and  Germany,  it  appears  that  parents  and  caregivers  absorb 
information they receive from different sources about young-child formulae. Figure 11 below 
summarises the most frequent answers given by respondents to the question "what influenced 
your  decision  to  give  young-child  formulae?".  In  the  case  of  France,  medical  advice  is 
reported  as  the  strongest  factor  influencing  the  decision,  followed  by  experience,  entourage 
and media. 

33 

 
 
 
Figure 11 – Answers given to the question "what influenced your decision to give young-child formulae?" (as a 
percentage of the sample (multiple answers were possible)) (source: NutriBébé survey) 

Medical advice

67%

Experience/instinct

59%

Entourage

20%

Media

19%

By way of comparison figures 12 and 13 below show the reasons given by respondents to the 
questions "why are you passing on to cow's milk?" and "what influenced your decision to give 
cow's milk?". The most common answers are focused on the right age of the young child to 
consume the product, the value for money aspect, experience, and practical implications. Only 
12% reported that their decision to pass on to cow's milk was linked to distrust in the benefits 
of young-child formulae.  

Figure 12 – Answers given to the question "why are you passing on to cow's milk?" (as a percentage of the 
sample (multiple answers were possible)) (source: NutriBébé survey) 

My child had the right age to consume it

It is good value for money

I already gave it to another child

It is simpler to have one milk for the entire family

46%

42%

33%

28%

My child prefers its taste

17%

It is good for the health of my child

It was recommended to me

14%

14%

I don't believe in the benefits of young-child formulae

12%

It better suits the nutritional needs of my child

10%

Experience/instinct  is  cited  as  the  most  common  influencing  factor  (the  influence  of 
experience  appears  higher  in  the  decision  to  give  cow's  milk  than  to  give  young-child 
formulae,  75%  vs.  59%).  Medical  advice  is  mentioned  only  by  28%  of  respondents  (while 

34 

 
 
 
 
67% of respondents mentioned medical advice as an influencing factor for the decision to use 
young-child formulae). 

Figure 13 – Answers given to the question "what influenced your decision to give cow's milk?" (as a percentage 
of the sample (multiple answers were possible)) (source: NutriBébé survey) 

Experience/instinct

75%

Entourage

Medical advice

Media

3%

31%

28%

4.3.3.  Recommendations of health care professionals and national authorities 

The  medical  community  in  France,  and  more  specifically  paediatricians,  support  the 
consumption  of  young-child  formulae  for  the  period  12-36  months.  Different  articles  have 
been written on the subject by paediatricians, and the consumption of young-child formulae is 
recommended at amounts of 500 ml per day (it is recommended not to exceed the total daily 
amount  of  800  ml/day  of  all  milk  products  in  order  to  avoid  excess  protein  intake)93.  It  is 
argued  that  the  daily  consumption  of  cow's  milk  after  one  year  risks  contributing  to 
inadequate intakes of a number of nutrients in young children. Consumption of young-child 
formulae contributes to avoiding the risk of inadequate intakes for all these nutrients (with the 
exception of vitamin D) without any risk for excess intakes (if recommended consumption is 
followed)94. 

The  paediatricians'  recommendations  on  consumption  of  young-child  formulae  are  in  line 
with those of the Programme National Nutrition Santé (PNNS), a public health plan launched 
in 2001 with  the  aim to  improve health through nutrition95. The  PNNS proposes  a series of 
nutrition recommendations based on scientific advice, with the aim to help the population and 
the professionals understand the information received on nutrition.  

93 

94 

95 

Bocquet A, Bresson JL, Briend A, Chouraqui JP, Darmaun D, Dupont C, Frelut ML, Ghisolfi J, Goulet O, 
Putet  G,  Rieu  D,  Turck  D,  Vidailhet  M,  Merlin  JP,  Rives  JJ,  2003,  Alimentation  du  nourrisson  et  de 
l’enfant en bas âge - Réalisation pratique, Archives de pédiatrie, 10(1), 76-81.  
Comité de nutrition de la Société française de pédiatrie (Ghisolfi J, Vidailhet M, Fantino M, Bocquet A, 
Bresson JL, Briend A, Chouraqui JP, Darmaun D, Dupont C, Frelut ML, Girardet JP, Goulet O, Hankard 
R, Rieu D, Turck D), 2011, Lait de vache ou lait de croissance : quel lait recommander pour les enfants 
en bas âge (1–3 ans) ? Archives de pédiatrie, 18(4), 355-358. 
http://www.mangerbouger.fr/pnns/ 

35 

 
 
 
                                                 
With respect to young-child formulae, the PNNS recommends96 their consumption until three 
years of age at amounts of 500 ml/day because of their adapted composition to the needs of 
young children. Alternatively, whole milk should be preferred to skimmed milk. The PNNS' 
recommendation  also  recognises 
to  occasionally  substitute  formula 
consumption  with  dairy  products  fortified  in  iron,  vitamins  and  essential  fatty  acids,  and  to 
introduce cheese in the diet. 

the  possibility 

4.4. Summary for Chapter 4  

The  data  described  in  sections  4.1.  to  4.3.  show  a  series  of  common  trends  with  respect  to 
different  aspects  related  to  the  behaviour  of  consumers  of  young-child  formulae  that  are 
confirmed,  with  some  variations,  by  the  information  provided  by  Member  States  and 
interested parties in the consultation phase. 

As  regards  consumption  data,  it  can  be  reported  that  breastfeeding  decreases  significantly 
after the age of one year in the different 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 the preference exist depending on the Member State. However, it can generally 
be reported that consumption of young-child formula is at its highest in the age range 12-18 
months. After this period, consumption of formula products decreases with age. At the same 
time, a corresponding increase in the consumption of cow's milk can be noted.  

As  regards  parents'  and  other  caregivers'  perception,  it  can  be  reported  that  in  the  different 
Member States, different sources influence parents' and caregivers' decisions on young-child 
formulae, including manufacturers through labelling and advertising, health care professionals 
and other persons in their entourage with previous experience (e.g. family, friends). The most 
common  arguments  put  forward  by  parents  and  caregivers  to  justify  preference  for  young-
child formulae are the suitability to the nutritional needs of young children, the superiority to 
cows' milk, its adapted composition, and the fact that the products correspond to the age of the 
young children. 

As regards recommendations of health care professionals and national authorities, significant 
differences can be reported among Member States. In certain Member States consumption of 
young-child formulae is recommended 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) instead of young-child 
formulae. In certain Member States, while young-child formulae are not recommended, health 
care professionals suggest the consumption of products with a specific composition, in order 
to better target the nutritional needs of young children. 

96 

http://www.mangerbouger.fr/pour-qui-242/enfants/la-phase-de-diversification-6-mois-3-ans/bien-manger-
57/la-3eme-etape-de-diversification-apres-1-an.html 

36 

 
 
                                                 
5.  EXISTING LEGAL FRAMEWORK APPLICABLE TO YOUNG-CHILD FORMULAE 

Young-child  formulae  are  currently  not  covered  by  specific  legislative  measures  under  EU 
law. Nevertheless, like all foods, they have to comply with the different provisions of EU law 
that are relevant for them. 
Pursuant  to  Article  17(1)  of  Regulation  (EC)  No  178/200297  (the  "General  Food  Law" 
Regulation), food business operators have the responsibility to ensure that the food they place 
on the market complies with the relevant provisions of EU law.    

National  competent  authorities  are  responsible  for  the  enforcement  of  EU  food  law  (Article 
17(2)  of  the  General  Food  Law  Regulation).  In  this  context,  they  are  competent  for  the 
classification of products and for deciding which legislation specific products have to comply 
with. This can result, in certain cases, in the same product having to comply with different EU 
legal acts depending on the Member States in which it is placed on the market.  
According to the information received from Member States' competent authorities98, young-
child  formulae  are  currently  classified  as  foodstuffs  intended  for  particular  nutritional  uses 
(so-called "dietetic foods") in 17 Member States99 and Norway. This legislation, however, has 
been repealed in 2013 with effect from 20 July 2016 (see Chapter 5.5).  

According  to  the  same  sources,  young-child  formulae  are  classified  as  foods  for  normal 
consumption fortified in certain nutrients pursuant to Regulation (EC) No 1925/2006100 in 10 
Member States101.  

This  Chapter  describes  the  rules  applicable  today  to  young-child  formulae  when  they  are 
classified  as  dietetic  foods  and  when  they  are  classified  as  foods  for  normal  consumption 
fortified in certain nutrients. It then describes some of the other horizontal rules of EU food 
law  young-child  formulae  have  to  comply  with,  regardless  of  young-child  formulae's 
classification status, and existing rules applicable to these products at national level. It finally 
summarizes  how  young-child  formulae  were  considered  in  the  revision  of  the  legislation 
applicable to dietetic foods that led to the adoption of the FSG Regulation. 

5.1. EU rules applicable to young-child formulae when classified as dietetic foods 

Directive  2009/39/EC  (recast  version  of  older  legislation,  first  adopted  in  1977)  defines 
foodstuffs  for  particular  nutritional  uses  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). Article 
1(3)  of  the  Directive  explains  that  "a  particular  nutritional  use  shall  fulfil  the  particular 
nutritional  requirements:  (a)  of  certain  categories  of  persons  whose  digestive  processes  or 
metabolism  are  disturbed;  or  (b)  of  certain  categories  of  persons  who  are  in  a  special 

97 

98 
99 

100 

101 

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). 
Different national competent authorities (2014). 
Bulgaria, Cyprus, Czech Republic, Croatia, Finland, France, Germany, Hungary, Ireland, Italy, Lithuania, 
Netherlands,  Poland,  Portugal,  Romania,  Slovenia  (although  the  products  only  recently  entered  the 
market) and Sweden. 
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). 
Austria, Belgium, Estonia, Greece, Latvia, Luxembourg, Malta, Slovakia, Spain, United Kingdom. 

37 

 
 
                                                 
physiological condition and who are therefore able to obtain special benefit from controlled 
consumption of certain substances in foodstuffs; or (c) of infants or young children in good 
health".  

Directive 2009/39/EC does not contain an exhaustive list of product categories that are to be 
considered dietetic foods. As already explained in the previous paragraph, on the basis of the 
definition given above, today, 17 Member States + Norway classify young-child formulae as 
dietetic  foods.  These  products  need  therefore  to  comply  with  the  rules  of  Directive 
2009/39/EC.   

Directive 2009/39/EC sets a series of general principles and requirements for dietetic foods. 
By  way  of  example,  it  foresees  that  "the  nature  or  composition  of  [dietetic  foods]  shall  be 
such  that  the  products  are  appropriate  for  the  particular  nutritional  use  intended"  (Article 
3(1)  of  the  Directive).  It  requires  dietetic  foods  to  "comply  with  any  mandatory  provisions 
applicable  to  foodstuffs  for  normal  consumption,  save  as  regards  changes  made  to  them  to 
ensure their conformity with the definitions (…)" (Article 3(2) of the Directive). It lays down a 
series of mandatory labelling requirements for these products (Article 9 of the Directive) to 
make  sure  that  dietetic  foods  provide  the  nutrition  declaration  (Article  9(3)(b)),  as  well  as 
indication of their particular nutritional characteristics (Article 9(2) and 9(3)(a)). In the case 
of  products  intended  for  infants  and  young  children  in  good  health,  that  indication  shall  be 
replaced  by  a  reference  to  the  purpose  for  which  they  are  intended.  According  to  Article 
2(2)(b)  of  the  Directive,  food  for  normal  consumption  cannot  be  labelled,  presented  or 
advertised  in  a  way  that  is  likely  to  give  the  impression  that  dietetic  foods  are  involved. 
Article  10(1)  of  the  Directive  then  foresees  that  "the  products  shall  only  be  allowed  on  the 
retail market in pre-packaged form, and the packaging shall completely cover the products". 

Article 4 of Directive 2009/39/EC foresees the adoption of specific provisions for a number of 
categories of dietetic foods listed in Annex to the Directive. With respect to foods for infants 
or  young  children  in  good  health,  the  Annex  does  not  list  young-child  formulae,  but  lists 
infant  formulae  and  follow-on  formulae  (specifically  regulated  today  by  Commission 
Directive  2006/141/EC)  and  processed  cereal-based  foods  and  baby  foods  (specifically 
regulated today by Commission Directive 2006/125/EC). 

Young-child  formulae  clearly  do  not  fall  under  the  scope  of  these  two  Commission 
Directives. Indeed, infant formulae and follow-on formulae are defined as foods intended for 
particular nutritional use by infants (i.e. children under the age of 12 months) (Article 2 (c) 
and (d) of Directive 2006/141/EC), unlike young-child formulae, which are foods intended for 
use  by  young  children  (i.e.  children  aged  between  one  and  three  years).  Directive 
2006/125/EC clearly excludes milks intended for young children from its scope (Article 1(3) 
of Directive 2006/125/EC). Since young-child formulae do not belong to any of the categories 
of dietetic foods for which specific rules were to be adopted, young-child formulae classified 
as dietetic food need to comply only with the general requirements of Directive 2009/39/EC.  

In  accordance  with  Article  11  of  Directive  2009/39/EC,  in  order  to  permit  efficient  official 
monitoring  of  dietetic  foods  which  do  not  belong  to  one  of  the  groups  listed  in  Annex, 
manufacturers  or  importers  of  dietetic  food  shall  notify  the  competent  authorities  of  the 
Member  States  where  the  product  is  placed  on  the  market,  by  forwarding  it  a  model  of  the 
label  used  for  the  product.  The  competent  authority  is  empowered,  where  necessary,  to 
require the manufacturer  or,  where  appropriate,  the  importer,  to  produce  the  scientific  work 
and the data establishing the product's compliance with Directive 2009/39/EC.  

38 

 
 
If young-child formulae are classified as dietetic foods they will also have to comply with the 
rules of Regulation (EC) No 953/2009102. 

5.2. EU  rules  applicable  to  young-child  formulae  when  classified  as  food  for  normal 

consumption fortified in certain nutrients 

Regulation (EC) No 1925/2006 "harmonises the provisions laid down by law, regulation or 
administrative action in Member States which relate to the addition of vitamins and minerals 
and  of  certain  other  substances  to  foods,  with  the  purpose  of  ensuring  the  effective 
functioning  of  the  internal  market,  whilst  providing  a  high  level  of  consumer  protection" 
(Article 1(1)).  

If  a  Member  State  does  not  classify  young-child  formulae  as  dietetic  foods,  it  will  consider 
these  products  as  foods  for  normal  consumption,  fortified  in  certain  nutrients,  and  therefore 
falling under the scope of Regulation (EC) No 1925/2006. In this case, young-child formulae 
have to comply with the rules of this Regulation103.  

The Regulation foresees that only vitamins and minerals listed in Annex to the Regulation in 
the  form  described  therein  can  be  added  to  foods  (Article  3(1)).  It  lays  down  general 
principles  for  the  addition  of  vitamins  and  minerals  to  foods  (Article  3(2)),  a  series  of 
restrictions  on  the  addition  of  vitamins  and  minerals  (Article  4),  rules  on  purity  criteria 
(Article  5)  and  specific  conditions  for  the  addition  of  vitamins  and  minerals  (Article  6). 
Article 6(1), in particular, foresees that "when a vitamin or a mineral is added to foods, the 
total amount of the vitamin or mineral present, for whatever purpose, in the food as sold shall 
not exceed maximum amounts". These amounts, to be established by the Commission, are not 
set yet and this condition is therefore not applicable for the moment. Article 6(6) establishes 
that  "the  addition  of  a  vitamin  or  a  mineral  to  a  food  shall  result  in  the  presence  of  that 
vitamin or mineral in the food in at least a significant amount where this is defined according 
to  [Annex  XIII  of  Regulation  (EU)  No  1169/2011  on  the  provision  of  food  information  to 
consumers104](…)". In the case of beverages, significant amounts are to be calculated as 7,5 % 
of the nutrient reference values for vitamins and minerals (for the adult population) specified 
in Annex XIII of Regulation (EU) No 1169/2011. These values are to be supplied by 100 ml 
of  the  product.  Article  6(6)  also  foresees  the  possibility  for  the  Commission  to  adopt 
"measures  determining  the  minimum  amounts,  including  any  lower  amounts,  by  derogation 
from the significant amounts mentioned above, for specific foods or categories of foods (…)". 

Article  7  of  the  Regulation  lays  down  requirements  on  the  labelling,  presentation  and 
advertising of foods to which vitamins and minerals have been added and foresees that such 
labelling, presentation and advertising: 

102 

103 

104 

Commission  Regulation  (EC)  No  953/2009  of  13  October  2009  on  substances  that  may  be  added  for 
specific nutritional purposes in foods for particular nutritional uses (OJ L 269, 14.10.2009, p. 9). 
Regulation  (EC)  No  1925/2006  applies  without  prejudice  to  the  provisions  concerning  "foods  for 
particular nutritional uses and, in the absence of specific provisions, compositional requirements of such 
products rendered necessary by the particular nutritional requirements of the persons for whom they are 
intended" (Article 1(3)(a) of Regulation (EC) No 1925/2006). 
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). 

39 

 
 
                                                 
a)  "(…) shall not include any mention stating or implying that a balanced and varied diet 

cannot provide appropriate quantities of nutrients (…)" (Article 7(1)); 

b)  "(…) shall not mislead or deceive the consumer as to the nutritional merit of a food 

that may result from the addition of these nutrients" (Article 7(2)). 

Article 7 of the Regulation also requires  mandatory nutrition labelling of products to which 
vitamins and minerals have been added. 

In order to facilitate efficient monitoring of foods to which vitamins and minerals have been 
added,  Article  15  of  the  Regulation  allows  Member  States  (but  does  not  require  them)  to 
require  the  manufacturer  or  the  person  placing  foods  containing  such  substances  on  the 
market  in  their  territory  to  notify  the  competent  authority  of  that  placing  on  the  market  by 
providing a model of the label used for the product.  

5.3. Other horizontal EU rules applicable to young-child formulae 

Regardless  of  whether  young-child  formulae  are  classified  as  dietetic  foods  pursuant  to 
Directive 2009/39/EC or foods for normal consumption fortified in certain nutrients pursuant 
to Regulation (EC) No 1925/2006, they need to comply with all the other relevant horizontal 
rules of EU food law that apply to them.  

By  way  of  example,  young-child  formulae  need  to  comply  with  the  requirements  of 
Regulation (EC) No 178/2002, in particular with Article 14(1)  and 14(2) whereby "1.  Food 
shall not be placed on the market if it is unsafe". "2. Food shall be deemed to be unsafe if it is 
considered to be: (a) injurious to health; (b) unfit for human consumption". 

Young-child formulae also need to comply with rules on labelling laid  down  by  Regulation 
(EU)  No  1169/2011  on  the  provision  of  food  information  to  consumers.  In  this  context, the 
labelling  of  young-child  formulae  must  provide  a  series  of  mandatory  particulars,  must 
comply with provisions laying down specific conditions for the provision of information on 
labelling  and  must  respect  some  general  principles  (that  also  apply  to  the  presentation  and 
advertising  of  young-child  formulae).    In  particular,  pursuant  to  Article  7(1)  of  Regulation 
(EU)  No  1169/2011,  the  labelling,  presentation  and  advertising  of  young-child  formulae 
"shall not be misleading, particularly: 

(a) as  to  the  characteristics  of  the  food  and,  in  particular,  as  to  its  nature,  identity, 
properties, composition, quantity, durability, country of origin or place of provenance, 
method of manufacture or production; 

(b) by attributing to the food effects or properties which it does not possess; 

(c)  by suggesting that the food possesses special characteristics when in fact all similar 
foods  possess  such  characteristics,  in  particular  by  specifically  emphasising  the 
presence or absence of certain ingredients and/or nutrients; 

(d) by  suggesting,  by  means  of 

the  description  or  pictorial 
the  appearance, 
representations, the presence of a particular food or an ingredient, while in reality a 
component  naturally  present  or  an  ingredient  normally  used  in  that  food  has  been 
substituted with a different component or a different ingredient". 

In addition, food information on young-child formulae "shall be accurate, clear and easy to 
understand for the consumer" (Article 7(2) of the Regulation). 

Young-child formulae then need to comply with the rules of Regulation (EC) No 1924/2006 
on  nutrition  and  health  claims  made  on  foods.  In  accordance  with  this  Regulation,  nutrition 
and health claims made in commercial communications, whether in the labelling, presentation 

40 

 
 
or  advertising  of  young-child  formulae,  must  be  based  on  and  substantiated  by  generally 
accepted scientific evidence (Article 1(2) and 6(1) of the Regulation). Only permitted claims 
that  are  included  in  lists  established  at  EU  level  on  the  basis  of  EFSA's  assessment  can  be 
used on young-child formulae, and provided that they comply with the general principles and 
requirements laid down in the Regulation as well as with the specific conditions existing for 
them. 

By  way  of  example,  Article  3  of the  Regulation foresees  that  "(…) the use of  nutrition and 
health claims shall not: 

a)  be false, ambiguous or misleading; 

b)  give rise to doubt about the safety and/or the nutritional adequacy of other foods;  

c)  encourage or condone excess consumption of a food; 

d)  state,  suggest  or  imply  that  a  balanced  and  varied  diet  cannot  provide  appropriate 

quantities of nutrients in general. (…) 

e)  refer  to  changes  in  bodily  functions  which  could  give  rise  to  or  exploit  fear  in  the 
consumer, either textually or through pictorial, graphic or symbolic representations". 

Article  4(1)  foresees  that:  "food  or  certain  categories  of  food  must  comply  with  [nutrient 
profiles] in order to bear nutrition or health claims (…)". Nutrient profiles, to be established 
by  the  Commission,  are  not  set  yet  and  this  condition  is  therefore  not  applicable  for  the 
moment. 

Article 5 of the Regulation foresees that: 

1.  "The  use  of  nutrition  and  health  claims  shall  only  be  permitted  if  the  following 

conditions are fulfilled: 

(a)  the  presence,  absence  or  reduced  content  in  a  food  or  category  of  food  of  a 
nutrient or other substance in respect of which the claim is made has been shown 
to have a beneficial nutritional or physiological effect, as established by generally 
accepted scientific evidence; 

(b)  the nutrient or other substance for which the claim is made: 

(i)  is  contained  in  the  final  product  in  a  significant  quantity  as  defined  in 
Community legislation or, where such rules do not exist, in a quantity that 
will produce the nutritional or physiological effect claimed as established 
by generally accepted scientific evidence; or 

(ii)  is  not  present  or  is  present  in  a  reduced  quantity  that  will  produce  the 
nutritional  or  physiological  effect  claimed  as  established  by  generally 
accepted scientific evidence; 

(c)  where applicable, the nutrient or other substance for which the claim is made is in 

a form that is available to be used by the body; 

(d)   the  quantity  of  the  product  that  can  reasonably  be  expected  to  be  consumed 
provides  a  significant  quantity  of  the  nutrient  or  other  substance  to  which  the 
claim  relates,  as  defined  in  Community  legislation  or,  where  such  rules  do  not 
exist, a significant quantity that will produce the nutritional or physiological effect 
claimed as established by generally accepted scientific evidence; 

(…) 

41 

 
 
2.  The use of nutrition and health claims shall only be permitted if the average consumer 
can be expected to understand the beneficial effects as expressed in the claim (…)". 

Article 9 of the Regulation lays down specific conditions on comparative nutrition claims:  

1.  "(…) a comparison may only be made between foods of the same category, taking into 
consideration  a  range  of  foods  of  that  category.  The  difference  in  the  quantity  of  a 
nutrient and/or the energy value shall be stated and the comparison shall relate to the 
same quantity of food.  

2.  Comparative  nutrition  claims  shall  compare  the  composition  of  the  food  in  question 
with a range of foods of the same category, which do not have a composition which 
allows them to bear a claim, including foods of other brands". 

Article 10 of the Regulation lays down specific conditions for health claims. In particular, it is 
foreseen that:  

2.  "(…) Health claims shall only be permitted if the following information is included in 

the labelling, or if no such labelling exists, in the presentation and advertising: 

(a) a statement indicating the importance of a varied and balanced diet and a healthy 

lifestyle; 

(b) the quantity of the food and pattern of consumption required to obtain the claimed 

beneficial effect; 

(…) 

(d) an  appropriate  warning  for  products  that  are  likely  to  present  a  health  risk  if 

consumed to excess. 

3.  Reference  to  general,  non-specific  benefits  of  the  nutrient  or  food  for  overall  good 
health  or  health-related  well-being  may  only  be  made  if  accompanied  by  a  specific 
health claim (…)". 

As explained in the guidance on the implementation of the Regulation (EC) No 1924/2006 on 
claims105,  since  young-child  formulae  are  products  intended  exclusively  to  young  children, 
health claims on these products should be considered as health claims referring to children's 
development  and  health  (covered  by  Article  14(1)(b)  of  the  Regulation).  These  claims  are 
listed on the EU Register of nutrition and health claims made on foods106. 

105 

106 

Directorate-General  for  Health  and  Consumers  (SANCO)  2007,  Guidance  on  the  implementation  of 
Regulation  N°  1924/2006  on  nutrition  and  health  claims  made  on  foods,  Conclusions  of  the  Standing 
Committee on the food chain and animal health 
http://ec.europa.eu/food/safety/docs/labelling_nutrition_claim_reg-2006-124_guidance_en.pdf 
http://ec.europa.eu/nuhclaims/ 

42 

 
 
                                                 
 
Finally, young-child formulae must comply with a number of other rules of EU food law (e.g. 
rules  on  food  additives107,  flavourings108,  pesticide  residues109,  contaminants110,  hygiene111, 
novel foods112). 

5.4. National rules applicable to young-child formulae 

As  of  today,  only  France  has  adopted  specific  national  rules  on  the  composition  of  young-
child  formulae113.  In  addition,  France  has  established  a  working  practice  for  these  products 
based  on  the  advice  of  the  Scientific  Committee  for  Food  (SCF)  of  1993  on  the  "essential 
composition of infant formulae and follow-on formulae". In that opinion, the SCF concluded 
that "if a formula is to be used by 1-3 year old children it should have the same composition 
as the follow-on formula made for infants"114. On that basis, if the young-child formula put on 
the  market  in  France  complies  with  the  requirements  of  follow-on  formula  laid  down  in 
Directive 2006/141/EC, it only needs to be notified to the French competent authorities. If the 
composition  is  different,  a  dossier  must  be  prepared  to  show  the  product's  safety  and 
suitability as foreseen by Directive 2009/39/EC115.  

In this context it should be noted that several other Member States have established working 
practices for assessing the composition of young-child formulae on the basis of the labelling 
reference  values  laid  down  in  Annex  VII  of  Directive  2006/141/EC  for  infants  and  young 
children116.  

107 

108 

109 

110 

111 

112  

113 

114 

115 
116 

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 1334/2008 of the European Parliament and of the Council of 16 December 2008 on 
flavourings and certain food ingredients with flavouring properties for use in and on foods and amending 
Council  Regulation  (EEC)  No  1601/91,  Regulations  (EC)  No  2232/96  and  (EC)  No  110/2008  and 
Directive 2000/13/EC (OJ L 354, 31.12.2008, p. 34). 
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). 
Council  Regulation  (EEC)  No  315/93  of  8  February  1993  laying  down  Community  procedures  for  
contaminants in food (OJ L 37, 13.2.1993, p. 1). 
Regulation  (EC)  No  852/2004  of  the  European  Parliament  and  of  the  Council  of  29  April  2004  on  the 
hygiene  of  foodstuffs  (OJ  L  139,  30.4.2004  p.1);  Regulation  (EC)  No  853/2004  of  the  European 
Parliament  and  of  the  Council  of  29  April  2004  laying  down  specific  hygiene  rules  for  food  of  animal 
origin (OJ L 139, 30.4.2004, p.55). 
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). 
Arrêté du 30 mars 1978 fixant les dispositions relatives aux aliments lactés diététiques, JO 24-05-1978 p. 
NC 4070-4075. 
Scientific  Committee  for  Food,  1993,  Report  on  the  essential  requirements  for  infant  formulae  and 
follow-on 
http://ec.europa.eu/food/safety/docs/labelling_nutrition-
special_groups_food-children-scf_reports_34_en.pdf 
France (2014). 
Different national competent authorities (2014). 

formulae, 

series, 

34th 

9, 

43 

 
 
                                                 
5.5. Young-child formulae and the FSG Regulation  

In 2011, the Commission adopted a proposal for a Regulation of the European Parliament and 
the  Council  to  revise  the  legislation  applicable  to  dietetic  foods117.  The  Commission's 
proposal  stemmed  from  the  considerations  that  more  and  more  food  products  exist  on  the 
market that target specific groups of the population and that the horizontal rules of EU food 
law adopted in the past 15 years (e.g. Regulation (EC) No 1924/2006 on nutrition and health 
claims, Regulation (EC) No 1925/2006 on fortified foods) adequately ensure, in most cases, 
protection of consumers and good functioning of the Internal Market.  

The Commission's proposal aimed at simplifying the existing legal framework, at abolishing 
the obsolete concept of "dietetic food" which had proven not fit for today's market and legal 
context, at repealing Directive 2009/39/EC and replacing it with a new framework covering 
foods for certain vulnerable groups of the population (i.e. infants, young children and people 
with specific diseases/disorders/medical conditions) for which specific rules were needed. In 
the  Commission's  view,  the  new  Framework  would  set  general  principles  and  requirements 
and  would  be  followed  by  delegated  acts  to  be  adopted  by  the  Commission  to  set  specific 
rules for the products included in the scope of the new Regulation (infant formulae, follow-on 
formulae,  processed  cereal-based  foods  and  baby  foods  for  infants  and  young  children  and 
food  for  special  medical  purposes).  In  the  Commission's  view,  food  for  other  population 
groups would be sufficiently covered by other horizontal rules of EU food law.  

The  Commission's  proposal  did  not  include  young-child  formulae  in  its  scope.  The  Impact 
Assessment that accompanied it118 did not specifically analyse the market of these products. 

During  the  negotiations  on  the  Commission's  proposal,  the  European  Parliament  adopted 
amendments  requiring  the  Commission  to  prepare  a  report  on  young-child  formulae. 
According to the European Parliament, a report, based on the advice of EFSA, should assess 
the  need  for  special  provisions  for  these  products.  The  Council  agreed  with  the  European 
Parliament in its common position and proposed to require the Commission to draft a report 
on these products within two years from the entry into force of the Regulation. The Council 
requested  the  Commission  to  consider  in  the  report,  among  others,  the  nutritional 
requirements of young children, the role of these products in the diet of young children and 
whether  these  products  have  any  nutritional  benefits  when  compared  to  a  normal  diet  for  a 
child  who  is  being  weaned.  The  Commission  agreed  with  the  European  Parliament  and  the 
Council on the usefulness of a report, especially taking into account that different views exist 
on whether these products are needed or not to satisfy the nutritional requirements of young 
children119.  

The  Commission's  proposal  was  amended  and  adopted  by  the  European  Parliament  and  the 
Council  on  12  June  2013  with  reference  (EU)  No  609/2013  (the  FSG  Regulation).  Young-
child formulae remain out of the scope of the FSG Regulation. However, as explained in the 

117 

118 

119 

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. 
European  Commission,  2011,  Staff  Working  Paper  -  Impact  Assessment  accompanying  the  document 
"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", SEC (2011) 762. 
European  Commission,  2013,  Communication  from  the  Commission  to  the  European  Parliament 
pursuant  to  Article  294(6)  of  the  Treaty  on  the  Functioning  of  the  European  Union  concerning  the 
position  of  the  Council  at  first  reading  with  a  view  to  the  adoption  of  a  Regulation  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, COM (2013) 241, p. 4-5. 

44 

 
 
                                                 
introduction  of  this  SWD,  Article  12  of  the  FSG  Regulation  required  the  Commission  to 
adopt a report on young-child formulae by 20 July 2015. 

The FSG Regulation will enter into application on 20 July 2016 and, on that date, Directive 
2009/39/EC will be repealed and the concept of "dietetic food" will disappear. Young-child 
formulae  placed  on  the  market  today  as  "dietetic  foods"  will  be  classified  as  normal  foods, 
fortified in certain nutrients and targeting a specific sub-group of the population (i.e. young 
children), as it is the case already in ten Member States. 

45 

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

As required by the FSG Regulation, in preparation for its report, the Commission consulted 
EFSA  and  asked  the  Authority  to  provide  advice  on  the  following  points  with  respect  to 
young-child formulae120: 

•  "Provide advice on the nutritional requirements of infants and young children and, in 
particular,  on  those  requirements  that  may  be  satisfied  by  breast  milk,  milk-based 
drinks and similar products. In this context it will also be important to provide advice 
to the Commission on how these nutritional requirements evolve during the age period 
0-3 years. 

(…) 

•  Provide  advice  on  the importance of  the role that 'growing-up milks' may have as a 
liquid  element  in  the  diet  of  young  children,  with  respect  to  elements  such  as  the 
pattern of consumption, the nutritional intake and any other relevant aspect related to 
exposure  to  substances  that  may  be  present  in  their  diet.  In  this  context  it  would  be 
useful to take into account that different products are on the market which may have a 
considerably varied composition. 

•  Provide advice on whether 'growing-up milks' are necessary to satisfy the nutritional 
requirements  of  young  children  or  have  any  nutritional  benefits  when  compared  to 
other foods that may be included in the normal diet of young children (such as breast 
milk, infant formulae, follow-on formulae,  cows' milk and other similar products).  

• 

If considered appropriate, advise the Commission with respect to the appropriate age 
range and the essential composition of 'growing-up milks'." 

EFSA provided its advice to the Commission in two different opinions: 

•  Scientific Opinion on nutrient requirements and dietary intakes of infants and young 

children in the European Union, adopted on 9 October 2013; 

•  Scientific  Opinion  on  the  essential  composition  of  infant  and  follow-on  formulae, 

adopted on 26 June 2014. 

In  its  first  opinion,  EFSA  first  analysed  the  nutritional  requirements  of  infants  and  young 
children  in  the  EU  by  identifying  the  levels  of  nutrients  considered  adequate  to  cover  the 
needs  of  the  majority  of  healthy,  term,  normal  weight  infants  and  young  children.  It  then 
compared these levels to data on intakes as well as to data on nutrient status for infants and 
young children, in order to identify critical nutrients in the diet of infants and young children 
for which there are risks of insufficient intakes in the EU. EFSA analysed different ways of 
tackling  intakes  of  these  critical  nutrients  and,  in  that  context,  analysed  the  role  of  young-
child formula in the diet of young children.  

Below are identified the most important aspects of EFSA's opinion of 2013: 

•  "Based  on  the  information  available,  the  Panel  considers  that  dietary  intakes  of  LA 
[linoleic  acid],  calcium,  phosphorus,  magnesium,  copper,  selenium,  chromium, 

120 

European Commission, 2013, Request for a scientific opinion on milk based drinks and similar products 
intended for infants and young children, Ares (2013) 238583. In preparation for the adoption of delegated 
Regulation  (EU)  2016/127  laying  down  specific  rules  for  infant  formulae  and  follow-on  formulae 
pursuant to Article 11(1) of the FSG Regulation, EFSA was also asked to provide advice on the essential 
composition requirements of infant formulae and follow-on formulae, by updating the relevant opinions 
of the Scientific Committee for Food on the matter. 

46 

 
 
                                                 
molybdenum,  manganese,  fluoride,  vitamin  A,  vitamin  E,  vitamin  K,  thiamin, 
riboflavin,  niacin,  pantothenic  acid,  pyridoxine,  biotin,  folate,  cobalamin,  vitamin  C 
and choline in infants and young children living in Europe do not give rise to concern 
over the risk of inadequate intakes". 

•  "Intakes of energy, protein, salt and potassium of infants and young children living in 
Europe are generally high and intakes of dietary fibre low. Intakes of protein, salt and 
potassium  do  not  reach  levels  which  are  of  concern.  The  Panel  notes  that  energy 
intakes above requirements may lead to an unfavourable gain in body mass". 

•  "Intakes  of  n-3  PUFAs  [omega-3  polyunsaturated  fatty  acids],  iron,  vitamin  D  and 
iodine in some infants and young children living in Europe are critical and (…) some 
sub-groups in this population may be at risk of inadequacy". 

•  "In the first year of life, formulae (infant and follow-on formulae) provide caregivers 
with a safe alternative to breast milk when breast milk is not available to the infant, 
and in replacement of cow’s milk, the consumption of which in large amounts in the 
first  year  of  life  is  generally  discouraged  in  infant  feeding  recommendations  and 
FBDG [food based dietary guidelines] of European countries". 

•  "After the first year of life, FBDG generally advise the use of cow’s milk in moderate 
quantities  (around  300  to  500  mL  per  day)  as  an  important  source  of  nutrients  for 
young children". 

•  "When  formulae  are  consumed  after  the  first  year  of  life,  they  continue  to  replace 
cow’s milk in whole or in part in the diet of young children which contains little or no 
ALA, DHA and iron and small amounts of vitamin D (…). However, at this age cow’s 
milk consumption is no longer discouraged and no recommendations for replacement 
of  this  food  category  by  other  alternatives  exist  from  medical  societies  at  European 
level". 

•  "Formulae,  including  young-child  formulae,  are  one  of  the  means  to  increase  n-3 
PUFA, iron and vitamin D intakes in infants and young children living in Europe with 
inadequate or at risk of inadequate status  of these nutrients. However, other means, 
such as fortified cow’s 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". 

•  "In  comparison  with  cow’s  milk,  currently  marketed  young-child  formulae  contain 
more  ALA,  DHA  (if  added),  iron  and  vitamin  D  but  similar  amounts  of  iodine.  The 
median  content  of  these  nutrients  in  young-child  formulae  is  within  the  range  of 
permitted  concentrations  in  follow-on  formulae  and,  except  for  iron,  also  in  infant 
formulae". 

•  "Therefore,  no  unique  role  of  young-child  formulae  with  respect  to  the  provision  of 
critical  nutrients  in  the  diet  of  infants  and  young  children  living  in  Europe  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 the normal diet of young children (such as breast milk, infant formulae, follow-on 
formulae and cow’s milk)."121 

121 

EFSA (2013) [format and order modified for the purposes of the document]. 

47 

 
 
                                                 
In its second opinion, after having proposed compositional requirements for infant formulae 
and  follow-on  formulae,  EFSA  covered  the  remaining  question  asked  by  the  Commission, 
namely whether EFSA considered it appropriate to advise the Commission with respect to the 
appropriate age range and the essential composition of young-child formulae. 

After  having  recalled  its  conclusions  from  the  first  opinion,  EFSA  noted  that  "formulae 
consumed during the first year of life can continue to be used by young children. Therefore, 
the  Panel  does  not  consider  it  necessary  to  propose  specific  compositional  criteria  for 
formulae consumed after one year of age ".122 

EFSA's second opinion was released as a draft for public consultation. The final opinion took 
into account the comments received and a technical report123 was published together with the 
opinion,  in  which  EFSA  commented  on  the  different  comments  received  (that  were  also 
published). 

122 
123 

EFSA (2014). 
EFSA,  2014,  Outcome  of  a  public  consultation  on  the  draft  Scientific  Opinion  of  the  EFSA  Panel  on 
Dietetic  Products,  Nutrition  and  Allergies  (NDA)  on  the  essential  composition  of  infant  and  follow-on 
formulae, EFSA supporting publication 2014:EN-633. 

48 

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

Member  States'  experts  and  interested  parties  shared  with  the  Commission  services  their 
views  on  young-child  formulae.  Below  is  provided  an  overall  summary  of  the  different 
positions124. 

The majority of Member States' experts expressed support (although to different extents) for 
additional action at EU level125. In this context, they often referred to: the increased level of 
consumer  protection  that  this  approach  would  ensure  for  vulnerable  consumers  (both  with 
respect to composition and marketing of young-child formulae), the increased legal certainty 
on the status of and rules applicable to the products, and the elimination of the risk of Member 
States adopting legislation at national level to regulate young-child formulae.  

Other Member States' experts expressed the different view that young-child formulae are not 
necessary for young children, as highlighted by EFSA, and raised the concern that additional 
action would enhance their status, make their consumption increase and, ultimately, possibly 
mislead consumers. These national authorities also referred to the experience in the Member 
States that currently consider young-child formulae as fortified foods. This experience shows, 
in their view, that horizontal rules of EU food law are sufficient to efficiently regulate these 
products.  

BEUC  (the  European  Consumer  Organisation)  argued  that  legislative  action  would  allow 
regulating the composition of young-child formulae to make it suitable for young children and 
restricting marketing practices used for these products. NGOs (IBFAN, the International Baby 
Food  Action  Network,  and  BFLG,  the  Baby  Feeding  Law  Group)  acknowledged  that  this 
approach  could  theoretically  allow  to  establish  an  appropriate  regulatory  framework  for 
young-child formulae and an adequate level of consumer protection. They, however, warned 
that  a  full  evaluation  can  only  be  carried  out  if  the  specific  provisions  that  would  apply  to 
young-child formulae are known (in their view, such specific provisions have, for example, a 
key role to ensure that consumers are informed that the products are not necessary).  

Young-child  formulae  manufacturers  (SNE)  called  for  additional  action  and  argued  that 
legislative  action  to  have  young-child  formulae covered  by  the  rules  on  follow-on  formulae 
could have a positive effect on consumer protection and on ensuring fair competition between 
operators. In their view, this approach would also guarantee legal clarity, free circulation of 
goods (as it would avoid adoption of rules at national level), innovation and competitiveness 
of  the  specific  sector.  This  approach  was  also  supported  by  the  associations  representing 
ingredients'  manufacturers  (ELC,  the  Federation  of  European  Specialty  Food  Ingredients 
Industries) and the dairy industry (EDA, the European Dairy Association, who underlined that 
specific rules on young-child formulae should ensure that dairy terms are protected and milk 
is not denigrated by comparisons with the composition of young-child formulae).    

124 

125  

This paragraph is based on the discussions in the different meetings of the Expert Group on food intended 
for infants and young children, food for special  medical purposes and total diet replacement for weight 
control (minutes available on DG SANTE website) and on all the documents submitted to DG SANTE on 
the matter during the consultation phase and afterwards. 
To include young-child formulae in the concept of follow-on formula and make them comply with some 
requirements applicable to follow-on formula. 

49 

 
 
 
 
 
 
 
 
                                                 
ENSA  (the  association  representing  natural  soy  products  manufacturers),  stated  that 
horizontal rules of EU food law are sufficient to regulate young-child formulae and expressed 
concerns that legislative action to have young-child formulae covered by the rules on follow-
on  formulae  would  force  manufacturers  of  soy-based  young-child  formulae  to  reformulate 
their products.  

50 

 
 
 
ANNEX I 

LIST OF INTERESTED PARTIES 

The interested parties listed below provided comments in writing to the Commission services 
on young-child formulae or participated to the meeting of the Working Group of the Advisory 
Group on the Food Chain and Animal and Plant Health of 19 September 2014 on the subject 

Acronym 

Full name 

AESGP 
BEUC 
BFLG 

CELCAA 
EDA 
EHPM 

ELC 
ENSA 
IBFAN 
PAN Europe 
SFAE 
SNE 

Association of the European Self-Medication Industry 
The European Consumer Organisation 
Baby  Feeding  Law  Group  (in  particular  Baby  Milk  Action  and 
First Steps Nutrition Trust) 
Comité Européen de liaison des commerces agroalimentaires 
European Dairy Association  
European  Federation  of  Associations  of  Health  Product 
Manufacturers 
Federation of European Specialty Food Ingredients Industries 
European Natural Soyfoods Manufacturers Association 
International Baby Food Action Network 
Pesticide Action Network Europe 
Secteur Français des Aliments de l’Enfance 
Specialised Nutrition Europe 

51 

 
 
 
 
ANNEX II 

BIBLIOGRAPHY 

(excluding legislation, websites, documents sent to the Commission) 

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 

Alexy  U,  Kersting  M,  2003,  Time  trends  in  the  consumption  of  dairy  foods  in  German 
children and adolescents, European Journal of Clinical Nutrition, 57, 1331-1337 

Alexy  U,  Kersting  M,  2010,  DONALD  News  Kindermilch  oder  Kuhmilch  in  der 
Kleinkindernährung, Ernährungs Umschau,  8: 405 

Bates  B,  Lennox  A,  Prentice  A,  Bates  C,  Page  P,  Nicholson  S  and  Swan  G  (Eds),  2014, 
National  Diet  and  Nutrition  Survey:  Results  from  Years  1,  2,  3  and  4  (combined)  of  the 
Rolling Programme (2008/2009 – 2011/2012) 

Bocquet A, Bresson JL, Briend A, Chouraqui JP, Darmaun D, Dupont C, Frelut ML, Ghisolfi 
J, Goulet O, Putet G, Rieu D, Turck D, Vidailhet M, Merlin JP, Rives JJ, 2003, Alimentation 
du  nourrisson  et  de  l’enfant  en  bas  âge  -  Réalisation  pratique,  Archives  de  pédiatrie,  10(1), 
76-81 

Bocquet  A,  Vidailhet  M,  2015,  Enquête  Nutri-Bébé  2013  Partie  2.  Comment  les  mères 
nourrissent-elles leur enfant? Archives de Pediatrie, 22 (10), Supplement 1, 10S7–10S19 

Bundesinstitut für Risikobewertung, 2014, Kindermilch – Abschlussbericht 

Comité de nutrition de la Société française de pédiatrie (Ghisolfi J, Vidailhet M, Fantino M, 
Bocquet A, Bresson JL, Briend A, Chouraqui JP, Darmaun D, Dupont C, Frelut ML, Girardet 
JP, Goulet O, Hankard R, Rieu D, Turck D), 2011, Lait de vache ou lait de croissance : quel 
lait recommander pour les enfants en bas âge (1–3 ans) ? Archives de pédiatrie, 18(4), 355-
358 

Crawley  H  and  Westland  S,  2013,  Fortified  milks  for  children  -  A  worldwide  review  of 
fortified milks marketed for children over 1 year of age, First Steps Nutrition Trust 

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 

EFSA, 2014, Outcome of a public consultation on the draft Scientific Opinion of the EFSA 
Panel  on  Dietetic  Products,  Nutrition  and  Allergies  (NDA)  on  the  essential  composition  of 
infant and follow-on formulae, EFSA supporting publication 2014:EN-633 

Eurostat, 2013, Detailed average prices report (2012) 

Ernährungskommission  der  Deutschen  Gesellschaft  für  Kinder-  und  Jugendmedizin  e.V. 
(DGKJ)    (Böhles  HJ,  Fusch  C,  Genzel-Boroviczén  O,  Jochum  F,  Kauth  T,  Kersting  M, 
Koletzko B, Lentze MJ, Mihatsch WA, Przyrembel H, Wabitsch M), 2011, Zusammensetzung 
und  Gebrauch  von  Milchgetränken  für  Kleinkinder  Aktualisierte  Empfehlungen  der 

52 

 
 
Ernährungskommission der Deutschen Gesellschaft für Kinder- und Jugendmedizin (DGKJ), 
Monatsschrift Kinderheilkunde, 10, 159:981–984 

Forschungsinstitut  für  Kinderernährung  Dortmund  (FKE),  2003,  Ernährungsphysiologische 
Auswertung einer repräsentativen Verzehrsstudie bei Säuglingen und Kleinkindern VELS mit 
dem Instrumentarium der DONALD Studie, Schlussbericht 

Hilbig A, 2005 Längerfristige Trends bei der Ernährung von Säuglingen und Kleinkindern der 
DONALD Studie im Zeitraum 1989 – 1999 

Kersting M, Dulon M, 2002, Assessment of breast-feeding promotion in hospitals and follow-
up  survey  of  mother-infant  pairs  in  Germany:  the  SuSe  Study.  Public  health  nutrition, 
Aug;5(4):547–552 

Koletzko  B,  Armbruster  M,  Bauer  C-P  et  al.,  2013,  Ernährung  und  Bewegung  im 
Kleinkindalter Handlungsempfehlungen des Netzwerks „Gesund ins Leben – Netzwerk Junge 
Familie“, ein Projekt von IN FORM, Monatsschrift Kinderheilkunde, 12 

Lennox  A,  Sommerville  J,  Ong  K.,  Henderson  H.  and  Allen  R.  (Eds),  2013,  Diet  and 
Nutrition Survey of Infants and Young Children, 2011 

Scientific Committee for Food, 1993, Report on the essential requirements for infant formulae 
and follow-on formulae, 34th series, 9 

Secteur Français des Aliments de l’Enfance, 2014, "Que révèle l'enquete NutriBébé 2013?", le 
Pédiatre, 262, XLX 

Tavoularis  G,  2015,  Enquête  Nutri-Bébé  2013  Partie  1.  Présentation  et  considérations 
méthodologiques, Archives de Pediatrie, 22 (10), Supplement 1, 10S1–10S6  

Tilgner  A,  Ehlers  A,  Röder  B,  Martin  A,  Weißenborn  A,  2013,  What  drives  parents  to  buy 
toddler milk?, Ernaehrungs Umschau international, 60(7): 116–123 

Turberg-Romain  C,  Lelievre  B,  Le  Heuzey  M-F,  2007,  Evolution  of  feeding  behaviours  in 
mothers  of  infants  and  young  children  from  1  to  36  months  old  in  France,  Archives  de 
Pediatrie, 14(10), 1250–1258 

Which?, 2013, Toddler milks – a winning formula? 

53