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
Date: 2011-06-20
Institutions: European Commission
Subjects: baby food, care of mothers and infants, early childhood, health care, human nutrition

EUROPEAN COMMISSION 

Brussels, 20.6.2011 
COM(2011) 353 final 

2011/0156 (COD) 

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  

(presented by the Commission pursuant to Article 114 of the Treaty on the Functioning 
of the European Union) 

(Text with EEA relevance) 

{SEC(2011) 762 final} 
{SEC(2011) 763 final} 

 
 
  
 
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

• 

Grounds for and objectives of the proposal 

The  proposal  revises  the  legislation  on  foodstuffs  intended  for  particular 
nutritional  uses  covered  by  Directive  2009/39/EC  the  so-called  "Framework 
Directive  on  dietetic  foods".  The  provisions  of  Directive  2009/39/EC  were 
originally  adopted  in  1977.  After  several  amendments,  a  recast  version  was 
adopted in 2009 to include the rules of the new Comitology procedure.  

Foodstuffs for particular nutritional uses are foods that are different from foods 
for normal consumption and are, as currently regulated, specially manufactured 
products  intended  to  satisfy  the  particular  nutritional  requirements  of  specific 
categories  of  the  population.  The  designation  under  which  a  dietetic  food  is 
sold is accompanied by a suitability statement for the particular nutritional use 
and  the  specific  group  of  the  population  to  whom  the  food  is  intended,  e.g.: 
gluten-free  food  for  celiac  people,  processed  cereal-based  food  for  young 
children, infant formulae for infants from birth etc. 

After more than 30 years of application, the evolution of both the food market 
and  food  legislation  makes  an  overall  revision  necessary.  Indeed,  the 
application of the broad concept of "foodstuffs for particular nutritional uses" 
on  which  the  Framework  Directive  is  based  in  the  evolved  market  and  legal 
context  has  led  to  considerable  problems  for  stakeholders  and  controlling 
authorities. The classification of many foods as 'dietetic' foods and the need for 
such  a  category  of  foods  has  been  seriously  questioned,  although  the 
desirability of maintaining rules on certain specific categories of foods actually 
addressing nutritional benefits for certain sub-groups of the population is being 
recognised. 

in  pursuing 

Consequently, 
regulation  and 
simplification,  the  proposal  aims  to  rectify  this  situation  by  simplifying  and 
clarifying the rules that apply to products hitherto regulated as 'dietetic' foods, 
taking into account the evolution of the regulatory measures in relevant areas. 

the  objectives  of  better 

Given  the  above,  the  proposal  abolishes  the  concept  of  dietetic  foods  and 
provides  for  a  new  framework  establishing  general  provisions  only  for  a 
limited  number  of  well-established  and  defined  categories  of  food  that  are 
considered as essential for certain vulnerable groups of the population, i.e. food 
intended  for  infants  and  young  children  and  food  for  patients  under  medical 
supervision.  

Further  to  these  objectives,  the  proposal  also  aims  at  creating  a  single  legal 
measure that regulates lists of substances such as vitamins, minerals and other 
substances  that  may  be  added  to  the  categories  of  food  covered  by  this 
proposal. The currently existing three different lists of substances included in 
three different legal measures would be combined into a single one. Clarity for 

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stakeholders and Member States and better Union administration would be the 
outcome of the establishment of such a merged measure. 

The revision of the legislation is accompanied by an impact assessment giving 
an overview of the application of Directive 2009/39/EC.  

• 

General context 

The main objective of the Framework Directive was to remove the differences 
between national laws relating to foodstuffs for particular nutritional uses, thus 
allowing their free movement and creating fair conditions of competitions. 

Discussions with Member States and stakeholders have highlighted increasing 
difficulties for implementing the Framework Directive, in particular in relation 
to  more  recent  pieces  of  Union  legislation  such  as  the  legislation  on  food 
supplements (Directive 2002/46/EC), on the addition of vitamins and minerals 
and  other  substances  to  foods  (Regulation  (EC)  No  1925/2006)  and  nutrition 
and  health  claims  (Regulation  (EC)  No  1924/2006).  In  effect,  as  the  food 
market evolved, so did the Union legislation governing it in order to ensure the 
functioning of the internal market and guarantee the same level of protection to 
citizens across Europe. 

This unclear situation has led also to distortions of trade in the internal market 
due to different interpretation and enforcement of Directive 2009/39/EC across 
Member  States  and 
its  scope  of  application. 
Furthermore,  it  appears  that  these  more  recently  adopted  Union  legislations 
mentioned  above  would  adequately  cover  all  products  addressing  nutritional 
benefits  for  the  general  population  and  certain  sub-groups  thereof  with  less 
administrative burden and more clarity as to their scope. 

in  particular  regarding 

As foreseen in the Framework Directive, Member States were asked for their 
views  and  experience  on  the  implementation  of  certain  provisions  of  that 
Directive in order to prepare Commission reports on 1) the implementation of 
the notification procedure of the Framework Directive on dietetic foods and 2) 
the  desirability  of  special  provisions  for  foods  for  persons  suffering  from 
carbohydrate-metabolism disorders (diabetic foods).  

As  regards  foods  for  diabetic  people,  the  Commission's  report  concludes  that 
there  is  no  scientific  basis  on  which  to  develop  specific  compositional 
requirements  for  this  category  of  food  and  that  diabetic  people  should  eat  as 
healthily  as  possible  choosing  a  diet  from  a  variety  of  food  for  normal 
consumption.  Also,  the  report  on  the  implementation  of  the  notification 
procedure  points  out  that  the  category  of  food  regulated  under  that  provision 
differs  significantly  between  Member  States  creating  as  a  result  market 
distortions.  On  top,  a  company  is  requested  to  notify  to  the  competent 
authorities each product they want to market as a 'dietetic' product and has to 
repeat  that  procedure  in  all  the  Member  States  where  they  wish  to  place  the 
product  on  the  national  market.  The  resulting  administrative  burden  is 
significant for both the Member States and the company while the added value 
in terms of public health and consumer information is questionable. 

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All abovementioned issues led to the need to consider an in depth and global 
revision of the legislation on dietetic foods.  

• 

Existing provisions in the area of the proposal 

The  following  pieces  of  legislation  cover  the  area  of  foods  for  particular 
nutritional uses: 

– 

Directive  2009/39/EC  on  foodstuffs  intended  for  particular  nutritional 
uses,  "the  Framework  Directive  on  dietetic  foods".  The  Directive  lays 
down a common definition on foods for particular nutritional uses as well 
as general provisions (e.g. a general notification procedure for categories 
for foods not covered by specific Commission legislation) and common 
labelling rules.  

According to the definition, foods for particular nutritional uses are foods 
that  are  different  from  foods  for  normal  consumption  and  are  specially 
manufactured  products  intended  to  satisfy  the  particular  nutritional 
requirements of specific categories of the population. 

Specific measures adopted for certain categories of foods under that framework 
legislation are: 

– 

Commission  Directive  2006/141/EC  on  infant  formulae  and  follow-on 
formulae. 

* 

– 

This  Directive  was  adopted  originally  in  1991  and  revised  globally  in 
2006.  It  establishes  detailed  and  complete  compositional  and  labelling 
rules for products intended to infants from birth up to 12 months of age. 
Infant formulae are suitable as the sole source of nourishment during first 
months of life if infants are not breastfed while follow-on formulae may 
constitute the principal liquid element in a progressively diversified diet. 

Council Directive 92/52/EEC on infant formulae and follow-on formulae 
intended  for  export  to  third  countries  established  the  rules  for  infant 
formulae  and  follow-on  formulae  exported  or  re-exported  from  the 
European Union to third countries. 

Commission  Directive  2006/125/EC  on  processed  cereal-based  foods 
and baby foods for infants and young children. 

Directive 2006/125/EC was adopted originally in 1996 and was codified 
in  2006.  This  Directive  covers  foods  that  are  intended  to  be  part  of  a 
diversified  diet  of  infants  and  young  children.  It  lays  down  general 
compositional  and  labelling  rules  for  a  large  diversity  of  products.  No 
major changes have been introduced since its first date of adoption. 

– 

Commission  Directive  1999/21/EC  on  dietary  foods  for  special  medical 
purposes. 

Dietary foods for special medical purposes are intended for the exclusive 
or  partial  feeding  of  patients  with  disturbed  capacity  to  take  ordinary 

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food and whose dietary management cannot be achieved by modification 
of  the  normal  diet  or  by  other  dietetic  foods.  It  establishes  general 
compositional criteria and quite detailed labelling rules. These foods are 
to be used under medical supervision. No updates have been made since 
1999. 

– 

Commission  Directive  96/8/EC  on  foods  intended  for  use  in  energy-
restricted diets for weight reduction. 

This  Directive  covers  two  categories  of  products  intended  for  weight 
control: products presented as a replacement for the whole daily diet and 
products presented as a replacement for  one  or  more  meals  of  the  daily 
diet. 

It  sets  general  compositional  and  compulsory  labelling  rules  for  these 
products. 

– 

Commission  Regulation  (EC)  No  41/2009  concerning  the  composition 
and labelling of foodstuffs suitable for people intolerant to gluten. 

This Regulation was adopted in 2009. A transitional period applies until 
1 January  2012.  It  fixes  gluten  thresholds  and  associated  labelling  rules 
for  the  voluntary  indication  of  the  absence  of  gluten  in  products  for 
people suffering from a permanent intolerance to gluten (coeliac people). 
The  Regulation  foresees  that  the  statement  'gluten-free'  can  be  used  on 
foods for normal consumption as well. 

– 

Commission  Regulation  (EC)  No  953/2009  on  substances  that  may  be 
added for specific nutritional purposes in foods for particular nutritional 
uses. 

This  Regulation  adopted  in  2009  updates  and  replaces  Directive 
2001/15/EC  and  established  a  consolidated  list  of  substances  such  as 
vitamins,  minerals,  and  other  substances  that  may  be  used  in  dietetic 
foods  except  those  that  can  be  used  in  infant  formulae  and  follow-on 
formulae  and  in  cereal-based  foods  and  other  baby  foods  which  are 
included  in  the  relevant  specific  Directives.  The  addition  of  new 
substances  to  that  list  is  subjected  to  the  scientific  assessment  of  the 
European Food Safety Authority (EFSA). 

• 

Consistency with the other policies and objectives of the Union 

The  proposal  is  in  line  with  the  Commission's  Better  Regulation  Policy,  the 
Lisbon Strategy and the EU's Sustainable Development strategy. The emphasis 
is  on  simplifying  the  regulatory  process,  thus  reducing  the  administrative 
burden  and  improving  the  competitiveness  of  the  European  food  industry, 
while  ensuring  the  safety  of  food,  maintaining  high  level  of  public  health 
protection and taking global aspects into consideration.  

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2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

• 

Consultation of interested parties 

Consultation  methods,  main  sectors 
respondents 

targeted  and  general  profile  of 

There was a broad consultation of all interested parties seeking their views on 
the provisions and application of existing legislation and the need for change. 
The respondents were the competent authorities of the Member States, industry 
association representatives and consumer organisations. 

Summary of responses and how they have been taken into account 

– 

– 

Consumer  organisations  main  concern  is  that  certain  foods  are  unduly 
covered  by  special  designation/status  under  the  current  Framework 
Directive  which  could  put  them  out  of  the  scope  of  other  important 
provisions  –  e.g.  Regulation  on  Nutrition  and  Health  Claims.  These 
stakeholders  have  highlighted  that  where  there  are  no  compositional  or 
labelling  requirements  justified  by  specific  nutritional  needs  and 
consumer  protection  there  is  no  need  to  grant  a  special  status  to  foods. 
This  is  especially  the  case  when  this  status  allows  the  food  to  bear  a 
suitability  statement  that  could  be  confused  with  a  nutrition  or  health 
claim  or  make  the  food  appear  more  appropriate  than  a  similar  normal 
food. 

The specialised 'dietetic food' industry believes that clear and transparent 
legislation  governing  the  composition  of  products  for  the  dietetic  food 
sector is essential to maintain the protection of vulnerable groups of the 
population and those with special nutritional needs from a public health 
and  food  safety  perspective.  In  that  context,  they  suggest  to  strengthen 
the  current  legislation  and  to  include  in  a  positive  list  at  least  the 
following groups of products: 'Foods for infants and young children up to 
the  age  of  three  -  including  Low  Birth  Weight  Formula';  'Hospital 
Discharge  Formula';  'Breast  Milk  Fortifier  and  Growing  Up  Milks'; 
'Foods for pregnant and lactating women'; 'Foods for the elderly in good 
health';  ‘Foods  for  weight  management’;  ‘Foods  for  special  medical 
purposes’;  ‘Foods  for  sportspeople’;  ‘Dietary  foods  for  people  with 
gluten intolerance’; ‘Lactose-free foods’. 

In  addition,  the  dietetic  food  industry  emphasises  the  need  for  a 
transparent,  efficient  and  effective  procedure  for  the  expansion  of  the 
Union list. They argue that science still emerges in this area and therefore 
a flexible procedure must be offered to promote innovation. 

Nevertheless,  this  position  is  not  shared  by  all  parts  of  the  industry; 
certain  others  believe  that  the  same  rules  should  apply  to  all  foods  and 
that  there  is  no  reason  to  foresee  different  rules  except  in  very  limited 
cases,  where  nutritional  food  safety  issues  are  concerned.  For  certain 
categories of foods, additional rules may result in unnecessary burden on 

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the industry. In addition, they fear that a legal straight jacket may hamper 
innovation. 

–  Member  States  have  reported  that  the  legislation  on  dietetic  foods  is 
being used by some operators to circumvent the rules of subsequent food 
legislation  such  as  the  Regulation  on  claims,  distorting  the  notion  of  a 
food  for  particular  nutritional  uses,  and  resulting,  in  certain  cases,  in 
confusion  over  its  application  that  creates  unfair  competition  between 
businesses and difficulties for enforcement.  

Member  States  underline  that  the  most  important  aspect  to  maintain 
would be consumer safety.  

The  Commission  identified  in  its  impact  assessment  supporting  the 
proposal four options taking into account the aforementioned issues and 
compared  them  in  light  of  the  objectives  of  the  revision  (coherence, 
simplification, harmonisation and small businesses and innovation). 

• 

Collection and use of expertise 

There was no need for external expertise. 

• 

Impact assessment 

The  Commission  carried  out  an  impact  assessment  which  is  presented  in 
parallel to this proposal as a Commission Staff Working Paper.  

Four  different  options  have  been  considered  ranging  from  repealing  the 
legislation  to  establishing  a  reinforced  legislation  for  dietetic  foods.  These 
options  were  assessed  taking  into  account  their  economic,  social  and 
environmental impacts on the various stakeholders and authorities. In addition, 
a no-change scenario was considered as a reference against which to assess the 
possible impacts of the different options.  

Two different approaches have been considered:  

(1) 

(2) 

the  notion  of  dietetic  food  is  no  longer  needed  to  help  the  food  market 
today and should be abolished; 

the notion of dietetic food needs to be strengthened to bring it more into 
line with today's food market and consumers' needs.  

The four options (two following approach (1) and two following approach (2)) 
considered within the Impact Assessment have been developed to  ensure  that 
none of them would result in the removal of products from the market but they 
may  necessitate  potential  label  changes  and/or  reformulation  of  products  or 
have  an  impact  on  their  market  value. In  other  words,  the  options  considered 
for the revision of the dietetic food legislation do not foresee any ban per se of 
foods  currently  sold  as  foods  for  particular  nutritional  uses.  In  addition,  the 
proposed  rules  within  each  option  would  allow  for  market  adaptation  and 
therefore  a  sufficient  transitional  period  is  foreseen  to  help  have  a  smooth 
transition to the new legislation and minimise economic burden. 

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Summary of the options and the key impacts under each of them: 

• 

Option 1 – Repeal all the legislation on dietetic foods (Framework Directive 
and all the specific Directives adopted under that Framework) 

Repealing the concept of dietetic food will prevent further distortions between 
'dietetic' foods with suitability statements and 'normal' foods with nutrition and 
health  claims.  However,  whilst  such  an  option  appears  to  be  a  good  one  in 
terms  of  simplification  and  reducing  administrative  burden,  the  trade  off  in 
terms  of  the  introduction  of  national  legislation  to  compensate  the  repeal  of 
certain  Union  legislation  (e.g.  on  foods  intended  for  infants  and  young 
children) may be significant.  

• 

Option 2 – Repeal the Framework Directive on dietetic foods but maintain 
certain of the specific rules adopted under that Framework 

This  option  provides  the  same  simplification  and  administrative  burden 
reduction  benefits  as  option  1  but  also  gives  the  Union  the  possibility  to 
maintain for certain categories of foods, rules the harmonisation of which has 
provided  added  value  at  EU  level.  Having  no  general  rules  on  dietetic  foods 
anymore  and  clearer  rules  for  certain  specific  products  should  ensure  better 
coordination between the requirements of different pieces of legislation.  

• 

Option 3 – Revision of the Framework Directive establishing a positive list 
of dietetic foods with specific compositional and/or labelling rules 

The  main  advantage  of  setting  a  positive  list  for  dietetic  foods  with  specific 
compositional and labelling rules is that standardised rules would apply to the 
dietetic  food  sector  ensuring  harmonisation  across  the  European  Union. 
However,  the  burden  that  would  fall  on  the  industry  and  Member  States  for 
having to comply with additional specific dietetic food legislation to be able to 
target  food 
the  population  may  be  considered 
disproportionate particularly taking into account the minimal additional public 
health and consumer information benefits.  

to  certain  groups  of 

• 

Option 4 – Amending the Framework Directive replacing the notification 
procedure  with  a  centralised  Union  prior-authorisation  procedure  based 
on a scientific assessment 

The application of a standard prior-authorisation procedure would ensure more 
harmonisation  across  the  European  Union  than  the  general  notification 
procedure currently in place. However, the burden of prior authorisation before 
using a 'dietetic' suitability statement on a product seems to be disproportionate 
in terms of consumers' protection and information and would be highly costly 
for the industry and especially for SMEs. 

The Commission proposal follows option 2 - Repeal the Framework Directive 
on  dietetic foods but maintain  certain of the specific rules adopted under that 
Framework. 

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3. 

LEGAL ELEMENTS OF THE PROPOSAL 

• 

Summary of the proposed action 

Adoption  of  a  Regulation  of  the  European  Parliament  and  of  the  Council 
establishing rules  applicable to foods intended for  infants  and  young children 
and  to  foods  for  special  medical  purposes  and  concerning  a  Union  list  of 
substances which can be added to the foods covered by this proposal.  

The  proposal  simplifies  and  clarifies  legal  requirements  applying  to  certain 
categories of foods and establishes a single list of substances that may be added 
to the foods ('Union list') covered by this proposal. In particular, it: 

– 

– 

– 

– 

– 

– 

– 

– 

– 

provides  a  new  general  Framework  legislation  applying  to  well-defined 
categories of foods that have been identified as essential for certain well-
established groups of consumers with specific nutritional needs; 

establishes a clear and defined scope of application; 

maintains specific measures for categories of foods that are essential for 
certain groups of the population; 

lays  down  general  rules  as  regards  the  composition  and  labelling 
applying to these categories of foods; 

removes  differences  in  interpretation  and  difficulties  for  Member  States 
and  operators  in  applying  different  pieces  of  food  legislation  by 
simplifying the regulatory environment;  

removes the burdens associated with the notification procedure; 

ensures  that  similar  products  are  treated  in  the  same  way  across  the 
Union;  

removes  rules 
potentially conflicting; 

that  have  become  unnecessary,  contradictory  and 

establishes a single legal measure for substances that can be added to the 
foods covered by this proposal; 

The  new  proposal  will  repeal  Directive  92/52/EC,  Directive  2009/39/EC, 
Directive 96/8/EC and Regulation (EC) No 41/2009.  

The specific compositional and information requirements will be laid down in 
delegated  Regulations,  adopted  by  the  Commission,  in  accordance  with 
Article 290  of  the  Treaty  on  the  Functioning  of  the  European  Union  (TFEU) 
taking into account the general requirements laid down in this proposal as well 
as Commission Directives 2006/141/EC, 2006/125/EC, and 1999/21/EC.  

The adoption of the Union list implies the application of criteria set out in this 
proposal therefore implementing powers shall be conferred on the Commission 

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in that respect. Those powers shall be exercised in accordance with Regulation 
(EU) No 182/2011. 

Emergency  procedures  are  foreseen  in  situations  where  food  covered  by  this 
proposal  constitutes  a  serious  risk  to  human  health.  For  this  purpose, 
implementing  powers  shall  be  conferred  on  the  Commission  in  that  respect. 
Those  powers  shall  be  exercised  in  accordance  with  Regulation  (EU)  No 
182/2011 of the TFEU. 

• 

Legal basis 

This proposal is based on Article 114 TFEU. This legal basis is justified both 
by  the  objective  and  the  content  of  the  proposal.  Measures  adopted  under 
Article  114  TFEU  should  have  as  their  object  the  establishment  and 
functioning of the internal market. The proposal establishes a harmonised legal 
framework concerning the composition and information requirements for infant 
formulae and follow-on formulae, processed cereal-based foods and baby foods 
for infants and young children and foods for special medical purposes as well 
as  a  Union  list  of  substances  that  can  be  added  to  such  foods  since  it  is 
necessary to keep a harmonized framework for products addressed to particular 
vulnerable  parts  of  the  population  for  which  categories  of  food  constitute  the 
sole  source  of  nourishment.  The  objective  of  the  proposal  is  to  avoid  any 
differences  between  national  laws  relating  to  the  categories  of  food  at  issue 
impeding  their  free  movement  and  thus  having  a  direct  impact  on  the 
establishment and functioning of the internal market. 

• 

Subsidiarity principle 

The subsidiarity principle applies insofar as the proposal does not fall under the 
exclusive competence of the Union. 

The objectives of the proposal cannot be sufficiently achieved by the Member 
States for the following reason(s): 

Prior to the adoption of the Framework Directive, the national measures in the 
Member  States  differed  from  one  Member  State  to  another.  The  differences 
between these laws obliged the dietetic food industry to vary their production 
according  to  the  Member  State  for  which  the  products  were  intended.  To 
respond  to  this,  general  rules  and  a  number  of  specific  measures  have  been 
adopted at Union level. 

In order to harmonise intra-union trade and trade with third countries the Union 
does  have  the  right  to  act.  However,  this  should  be  balanced  against  the 
proportionality  of  the  measure  and  the  added  value  Union  rules  will  have  for 
citizens across all Member States.  

Individual action by Member States could lead to differing levels of food safety 
and  protection  of  human  health  and  confuse  consumers.  In  addition,  it  would 
endanger the free movement of these foods in the Union. 

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The core of the Union action would maintain existing rules for certain products 
that are traded widely within the Union and where there is agreement amongst 
Member States for the continuing need for specific composition and labelling 
rules to ensure the free movement of these goods. It also aims to simplify the 
regulatory  environment  as  regards  the  addition  of  substances  to  the  foods 
covered by this proposal. 

The proposal therefore complies with the subsidiarity principle. 

• 

Proportionality principle 

The  proposal  complies  with  the  proportionality  principle  for  the  following 
reason(s): 

The  proposal  harmonises  the  regulatory  framework  establishing  general 
provisions applying to certain categories of foods where the need for additional 
compositional  and  labelling  provisions  to  the  general  rules  applying  to  all 
foods  is  demonstrated.  Such  additional  provisions  contribute  to  consumer 
protection by ensuring that consumers receive nutritionally adequate foods and 
appropriate information.  

The  proposed  measures  are  sufficient  in  terms  of  reaching  the  objectives  of 
ensuring  that  consumers  make  informed  and  safe  choices  and  securing  the 
smooth functioning of the internal market. At the same time they do not impose 
an excessive or unjustified burden. 

The  absence  of  harmonisation  for  these  categories  of  foods  would  result  in  a 
proliferation  of  national  rules  resulting  in  different  levels  of  consumer 
protection between the Member States and increased burden for the industry.  

The  financial  burden  is  minimised  as  the  current  specific  provisions  exist 
already,  the  general  provisions  are  only  simplified  and  clarified  as  to  their 
scope of application. 

• 

Choice of instruments 

Proposed instruments: Regulation. 

Other type of measure would not be adequate for the following reason(s). 

The  existing  framework  is,  in  general,  prescriptive  with  little  flexibility  for 
Member States in how it should be applied. A Directive would have lead to an 
inconsistent approach in  the Union leading to uncertainty for both consumers 
and the industry. A Regulation provides a consistent approach for industry to 
follow  and  reduces  the  administrative  burden  as  operators  do  not  need  to 
familiarise  themselves  with  the  individual  national  legislation  in  the  Member 
States. 

Soft  law  instruments  such  as  guidelines  would  be  a  flexible  approach  to 
addressing certain changes needed in the current legislation but not all of them. 
In addition, due to the non-binding status such instruments are considered not 

EN 

10 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
sufficient to tackle differences in the interpretation and implementation of the 
legislation.  

4. 

BUDGETARY IMPLICATION 

None. 

5. 

ADDITIONAL INFORMATION 

• 

Simulation, pilot phase and transitory period 

There will be a transitory period for the application of the proposal. 

• 

Simplification 

The proposal provides for simplification of legislation. This is one of the main 
objectives  of  the  revision  of  the  legislation  on  foods  for  particular  nutritional 
uses. 

The  use  of  a  Regulation  as  the  legal  instrument  supports  the  objective  of 
simplification  because  it  guarantees  that  all  actors  have  to  follow  the  same 
rules at the same time. 

National  administrative  procedures  following  the  implementation  of  the 
general  notification  procedure  will  be  abolished  reducing  the  administrative 
burden associated with the implementation of the legislation. 

The provisions adopted in and under Directive 2009/39/EC that have become 
unnecessary, contradictory and potentially conflicting will be removed. 

The proposal is included in the Commission  Working  Programme for  2011 – 
Annex  III  –  Simplification  Rolling  Programme  and  Administrative  Burden 
Reduction initiatives under the reference 2009/SANCO/004. 

• 

Repeal of existing legislation 

The adoption of the proposal will lead to the repeal of existing legislation. 

• 

Recasting 

The proposal involves recasting. 

• 

European Economic Area 

The proposed act concerns an EEA matter and should therefore extend to the 
European Economic Area. 

• 

Detailed explanation of the proposal 

The Regulation provides the basis for the assurance of a high level of consumer 
protection  in  relation  to  foods  intended  for  infants  and  young  children  and  to 

EN 

11 

   EN 

 
 
 
 
 
 
 
 
 
 
 
foods  for  special  medical  purposes.  It  establishes  also  a  single  legal  measure 
that regulates the list of substances that can be added to the foods covered by 
the proposal (Chapter I). 

Chapters  II  and  III  provide  for  general  principles  and  specific  provisions  that 
shall apply to infant formulae and follow-on formulae, processed cereal-based 
foods  and  baby  foods  for  infants  and  young  children  and  foods  for  special 
medical purposes. 

Chapter IV relates to the establishment of a Union list of substances that can be 
added  to  the  foods  covered  by  the  proposal  and  provides  for  a  procedure  for 
updating the Union list. 

Chapter V provides for a general confidentiality clause. 

Chapter  VI  and  VII  concerns  all  the  procedural  provisions  related  to  the 
implementation of the new proposal, the delegation of powers, the procedures, 
the necessary amendments and the measures that are to be repealed. It specifies 
also  the  transitional  measures  that  would  apply  to  the  categories  of  foods 
currently regulated under Directive 2009/39/EC and the date of entry into force 
and application. 

EN 

12 

   EN 

 
 
 
 
 
2011/0156 (COD) 

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  

(presented by the Commission pursuant to Article 114 of the Treaty on the Functioning 
of the European Union) 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 114 thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national Parliaments, 

Having regard to the opinion of the European Economic and Social Committee, 

Acting in accordance with the ordinary legislative procedure1, 

Whereas: 

(1) 

(2) 

(3) 

Article 114 of the Treaty on the Functioning of the European Union (TFEU) provides 
that measures having as their object the establishment and functioning of the internal 
market and which concern inter alia health, safety and consumer protection must take 
as  a  base  a  high  level  of  protection  taking  account  in  particular  of  any  new 
development based on scientific facts.  

The free movement of safe and wholesome food is an essential aspect of the internal 
market  and  contributes  significantly  to  the  health  and  well-being  of  citizens,  and  to 
their social and economic interests. 

Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 
on foodstuffs  intended for particular nutritional uses2 lays down general rules on the 
composition  and  preparation  of  such  foods  that  are  specially  designed  to  meet  the 
particular  nutritional  requirements  of  the  persons  to  whom  they  are  intended.  The 

1 

2 

Position of the European Parliament of … and position of the Council at first reading of ... Position of 
the European Parliament of ... and decision of the Council of .... 
OJ L 124, 20.5.2009, p. 21. 

EN 

13 

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(4) 

(5) 

(6) 

(7) 

majority  of  the  provisions  laid  down  in  that  Directive  date  back  to  1977  and  should 
therefore be reviewed. 

Directive  2009/39/EC  establishes  a  common  definition  for  'foodstuffs  for  particular 
nutritional uses' and general labelling requirements, including that such foods should 
bear an indication of their suitability for the claimed nutritional purposes.  

The  general  composition  and  labelling  requirements  laid  down  in  Directive 
2009/39/EC are complemented by a number of non-legislative Union acts, which are 
applicable  to  specific  categories  of  food.  In  that  respect,  Commission  Directive 
2006/141/EC of 22 December 2006 lays down harmonised rules with respect to infant 
formulae  and  follow-on  formulae3,  whereas  Commission  Directive  2006/125/EC  of 
5 December 2006 lays down certain harmonised rules with respect to processed cereal-
based  foods  and  baby  foods  for  infants  and  young  children4.  Similarly,  harmonised 
rules  are  also  laid  down  by  Commission  Directive  96/8/EC  of  26  February  1996  on 
foods  intended  for  use  in  energy-restricted  diets  for  weight  reduction5,  Commission 
Directive  1999/21/EC  of  25  March  1999  on  dietary  foods  for  special  medical 
purposes6  and  Commission  Regulation  (EC)  No  41/2009  of  20  January  2009 
concerning  the  composition  and  labelling  of  foodstuffs  suitable  people  intolerant  to 
gluten7. 

In addition, Council Directive 92/52/EEC of 18 June 1992 lays down harmonised rules 
with  respect  to  infant  formulae  and  follow-on  formulae  intended  for  export  to  third 
countries8. 

Directive 2009/39/EC foresees that specific provisions could be adopted regarding the 
two following specific categories of food falling within the definition of foodstuffs for 
particular nutritional uses: 'food intended to meet the expenditure of intense muscular 
effort,  especially  for  sportsmen'  and  'food  for  persons  suffering  from  carbohydrate 
metabolism disorders (diabetes)'. With regard to food intended to meet the expenditure 
of  intense  muscular  effort,  no  successful  conclusion  could  be  reached  as  regard  the 
development  of  specific  provisions  due  to  widely  diverging  views  among  Member 
States and stakeholders concerning the scope of the specific legislation, the number of 
sub-categories  of  the  food  to  be  included,  the  criteria  for  establishing  composition 
requirements  and  the  potential  impact  on  innovation  in  product  development.  As 
regards  special  provisions  for  food  for  persons  suffering  from  carbohydrate 
metabolism  disorders  (diabetes),  a  Commission  report9  concludes  that  the  scientific 
basis for setting specific compositional requirements is lacking.  

(8) 

Directive  2009/39/EC  also  requires  a  general  notification  procedure  at  national  level 
for  food  presented  by  food  business  operators  as  falling  under  the  definition  of 
'foodstuffs for particular nutritional uses' and for which no specific provisions are laid 

3 
4 
5 
6 
7 
8 
9 

OJ L 401, 30.12.2006. p. 1.  
OJ L 339, 6.12.2006, p. 16. 
OJ L 55, 6.3.1996, p. 22. 
OJ L 91,7.4.1999, p. 29.  
OJ L 16, 21.1.2009, p. 3. 
OJ L 179, 1.7.1992, p. 129. 
COM (2008) 392 Report from the Commission to the European Parliament and the Council on foods 
for persons suffering from carbohydrate metabolism disorders (diabetes), Brussels, 26.6.2008. 

EN 

14 

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down in Union law, prior to their placing on the Union market, in order to facilitate the 
efficient monitoring of such food by the Member States.  

(9) 

A  report  from  the  Commission  to  the  European  Parliament  and  the  Council  on  the 
implementation of that notification procedure10 showed that difficulties may arise from 
different  interpretations  of  the  definition  of  foodstuffs  for  particular  nutritional  uses 
which  appeared  to  be  open  to  different  interpretations  by  the  national  authorities.  It 
therefore  concluded  that  a  revision  of  the  scope  of  Directive  2009/39/EC  would  be 
required  to  ensure  a  more  effective  and  harmonised  implementation  of  the  Union 
legislation.  

(10)  A study report11concerning the revision of the legislation on foodstuffs for particular 
nutritional uses confirms the findings of the Commission report on the implementation 
of the notification procedure and indicates that an increasing number of foodstuffs are 
today marketed and labelled as foodstuffs suitable for particular nutritional uses, due 
to  the  broad  definition  laid  down  in  Directive  2009/39/EC.  The  study  report  also 
points  out  that  the  type  of  food  regulated  under  that  legislation  differs  significantly 
between Member States; similar food could at the same time be marketed in different 
Member  States  as  food  for  particular  nutritional  uses  and/or  as  food  for  normal 
consumption  addressed  to  the  population  in  general  or  to  certain  sub-groups  thereof 
such  as  pregnant  women,  postmenopausal  women,  older  adults,  growing  children, 
adolescents, variably active individuals and others. This state of affairs undermines the 
functioning of the internal market, creates legal uncertainty for competent authorities, 
food  business  operators  and  consumers,  while  the  risks  of  marketing  abuse  and 
distortion of competition cannot be ruled out.  

(11) 

It appears that other Union acts recently adopted are more adapted to an evolving and 
innovative  food  market  than  Directive  2009/39/EC.  Of  particular  relevance  and 
importance in that respect are: Directive 2002/46/EC of the European Parliament and 
the Council of 10 June on the approximation of the laws of the Member States relating 
to food supplements12, Regulation (EC) No 1924/2006 of the European Parliament and 
the Council of 20 December 2006 on nutrition and health claims made on foods13 and 
Regulation  (EC)  No  1925/2006  of  the  European  Parliament  and  the  Council  of  20 
December  2006  on  the  addition  of  vitamins  and  minerals  and  other  substances  to 
foods14. Furthermore, the provisions of these Union acts would adequately regulate a 
number  of  the  categories  of  food  covered  by  Directive  2009/39/EC  with  less 
administrative burden and more clarity as to the scope and objectives.  

(12)  Moreover, experience shows that certain rules included in or adopted under Directive 

2009/39/EC are no longer effective to ensure the functioning of the internal market.  

10 

11 

12 
13 
14 

Report  from  the  Commission  to  the  European  Parliament  and  the  Council  on  the  implementation  of 
Article  9  of  Council  Directive  89/398/EEC  on  the  approximation  of  the  laws  of  the  member  States 
relating to foodstuffs intended for particular nutritional uses, COM (2008)393, dated 27.6.2008. 
An analysis of the European, social and environmental impact of the policy options for the revision of 
the Framework Directive on dietetic foods – Study report Agra CEAS Consulting, dated 29.4.2009.. 
OJ L 183, 12.7.2002, p. 51. 
OJ L 404, 30.12.2006, p. 9. 
OJ L 404, 30.12.2006, p. 26. 

EN 

15 

   EN 

 
                                                 
(13)  Therefore,  the  concept  of  “foodstuffs  for  particular  nutritional  uses”  should  be 
abolished and Directive 2009/39/EC should be replaced by the present act. To simplify 
its application and to ensure consistency throughout the Member States, the present act 
should take the form of a Regulation. 

(14)  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 safety15 establishes common principles and definitions for Union food 
law in order to ensure a high level of health protection and the effective functioning of 
the internal market. It establishes the principles of risk analysis in relation to food and 
establishes the structures and mechanisms for the scientific and technical evaluations 
which are undertaken by the European Food Safety Authority (hereinafter referred to 
as  'the  Authority').  Therefore,  certain  definitions  laid  down  in  that  Regulation  must 
also apply in the context of the present Regulation. Moreover, for the purpose of this 
Regulation,  the  Authority  should  be  consulted  on  all  matters  likely  to  affect  public 
health.  

(15)  A limited number of categories of food constitutes the sole source of nourishment of 
certain  groups  of  the  population  or  represent  a  partial  source  of  nourishment;  such 
categories  of  food  are  vital  for  the  management  of  certain  conditions  and/or  are 
essential  to  maintain  the  intended  nutritional  adequacy  for  certain  well-established 
vulnerable groups of the population. Those categories of food include infant formulae 
and  follow-on  formulae,  processed  cereal-based  food  and  baby  food  and  food  for 
special  medical  purposes.  Experience  has  shown  that  the  provisions  laid  down  in 
Commission Directive 2006/141/EC, Commission Directive 2006/125/EC, as well as 
Commission  Directive  1999/21/EC  ensure  the  free  movement  of  such  food  in  a 
satisfactory  manner,  while  ensuring  a  high  level  of  protection  of  public  health.  It  is 
therefore  appropriate  that  this  Regulation  focuses  on  the  general  compositional  and 
information requirements for infant formula and follow-on formulae, processed cereal-
based  food  and  baby  food  for  infants  and  young  children  and  to  food  for  special 
medical  purposes, 
into  account  Commission  Directive  2006/141/EC, 
Commission Directive 2006/125/EC and Commission Directive 1999/21/EC. 

taking 

(16)  To  ensure 

laid  down 

legal  certainty,  definitions 

in  Commission  Directive 
2006/141/EC,  Commission  Directive  2006/125/EC  and  Commission  Directive 
1999/21/EC  should  be  transferred  to  this  Regulation.  However,  the  definitions  of 
infant formulae and follow-on formulae, processed cereal-based food and baby food, 
and food for special medical purposes should be regularly adapted taking into account 
technical  and  scientific  progress  and  relevant  developments  at  international  level,  as 
appropriate. 

(17) 

It  is  important  that  ingredients  used  in  the  manufacture  of  the  categories  of  food 
covered  by  this  Regulation  are  appropriate  to  satisfy  the  nutritional  requirements  of, 
and  are  suitable  for  the  persons  to  whom  they  are  intended  and  that  their  nutritional 
adequacy  has  been  established  by  generally  accepted  scientific  data.  Such  adequacy 
should be demonstrated through a systematic review of the available scientific data.  

15 

OJ L 31, 1.2.2002, p. 1.  

EN 

16 

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(18)  General labelling requirements are laid down in Directive 2000/13/EC of the European 
Parliament and of the Council of 20 March 2000 on the approximation of the law of 
the  Member  States  relating  to  labelling,  presentation  and  advertising  of  foodstuffs16. 
Those general labelling requirements should, as a general rule, apply to the categories 
of food covered by this Regulation. However, this Regulation should also provide for 
additional  requirements  to,  or  derogations  from,  the  provisions  of  Directive 
2000/13/EC,  where  necessary,  in  order  to  meet  the  specific  objectives  of  this 
Regulation.  

(19)  This  Regulation  should  provide  the  criteria  for  the  establishment  of  the  specific 
compositional  and  information  requirements  for  infant  formula,  follow-on  formula, 
processed  cereal-based  food  and  baby  food,  and  food  for  special  medical  purposes, 
taking  into  account  Commission  Directive  2006/141/EC,  Commission  Directive 
2006/125/EC and Commission Directive 1999/21/EC. In order to adapt the definitions 
of infant formula, follow-on formula, processed cereal-based food and baby food, and 
food  for  special  medical  purposes  laid  down  in  this  Regulation  taking  into  account 
technical  and  scientific  progress  and  relevant  developments  at  international  level,  to 
lay down the specific compositional and information requirements with respect to the 
categories  of  food  covered  by  this  Regulation,  including  for  additional  labelling 
requirements to, or derogations from, the provisions of Directive 2000/13/EC and for 
the authorisation of nutrition and health claims, the power to adopt acts in accordance 
with  Article  290  of  the  Treaty  on  the  Functioning  of  the  European  Union  should  be 
delegated  to  the  Commission.  It  is  of  particular  importance  that  the  Commission 
carries  out  appropriate  consultations  during  its  preparatory  work,  including  at  expert 
level. The Commission, when preparing and drawing-up delegated acts, should ensure 
a  simultaneous,  timely  and  appropriate  transmission  of  relevant  documents  to  the 
European Parliament and Council.  

(20) 

It is appropriate to establish and update a Union list of vitamins, minerals, amino acids 
and  other  substances  that  may  be  added  to  infant  formula,  follow-on  formula, 
processed  cereal-based  food  and  baby  food,  and  food  for  special  medical  purposes, 
subject to certain criteria laid down in this Regulation. Given the fact that the adoption 
of the list implies the application of criteria set out in this Regulation, implementing 
powers should be conferred on the Commission in that respect. Those powers should 
be  exercised  in  accordance  with  Regulation  (EU)  No  182/2011  of  the  European 
Parliament and of the Council of 16 February 2011 laying down the rules and general 
principles concerning mechanisms for control by Member States of the Commission's 
exercise  of  implementing  powers17.  The  Commission  should  adopt  immediately 
applicable  implementing  acts  updating  the  Union  list,  where,  in  duly  justified  cases 
relating to public health, imperative grounds of urgency so require.  

(21)  At  present,  pursuant  to  the  Opinion  of  the  Scientific  Committee  on  Emerging  and 
Newly  Identified  Health  Risks  (SCENIHR)18  on  the  risk  assessment  of  products  of 
nanotechnologies, dated 19 January 2009, there is inadequate information on the risks 
associated  with  engineered  nanomaterials  and  existing  test  methods  may  not  be 

16 
17 
18 

OJ L 184, 17.7.1999, p. 23. 
OJ L 55, 28.2.2011, p. 13. 
Scientific  Committee  established  by  Commission  Decision  of  5  August  2008  setting  up  an  advisory 
structure  of  Scientific  Committees  and  experts  in  the  field  of  consumer  safety,  public  health  and  the 
environment and repealing Decision 2004/210/EC (2008/721/EC), OJ L 241, 10.9.2008, p. 21. 

EN 

17 

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sufficient  to  address  all  of  the  issues  arising  in  relation  to  engineered  nanomaterials. 
Therefore, engineered nanomaterials should not be included in the Union list for the 
categories of food covered by this Regulation, until an evaluation by the Authority is 
carried out.  

(22) 

(23) 

In the interests of efficiency and legislative simplification, there should be a medium-
term examination of the question whether to extend the scope of the Union list to other 
categories of food governed by other specific Union legislation.  

It  is  necessary  to  establish  procedures  for  the  adoption  of  emergency  measures  in 
situations where food covered by this Regulation constitutes a serious risk to human 
health.  In  order  to  ensure  uniform  conditions  for  the  implementation  of  emergency 
measures,  implementing  powers  should  be  conferred  on  the  Commission.  Those 
powers  should  be  exercised  in  accordance  with  Regulation  (EU)  No  182/2011.  The 
Commission  should  adopt  immediately  applicable  implementing  acts  relating  to 
emergency  measures,  where,  in  duly  justified  cases  relating  to  public  health, 
imperative grounds of urgency so require. 

(24)  Council  Directive  92/52/EEC  states  that  infant  formulae  and  follow-on  formulae 
exported  or  re-exported  from  the  European  Union  have  to  comply  with  Union  law 
unless  otherwise  required  by  the  importing  country.  This  principle  has  already  been 
established  for  food  in  Regulation  (EC)  No  178/2002.  For  the  sake  of  simplification 
and legal certainty, Directive 92/52/EEC should therefore be repealed.  

(25)  Regulation  (EC)  No  1924/2006  of  the  European  Parliament  and  of  the  Council  of 
20 December  2006  on  nutrition  and  health  claims  made  on  foods19  establishes  the 
rules  and  conditions  for  the  use  of  nutrition  and  health  claims  on  food.  Those  rules 
should  apply  as  a  general  rule  to  the  categories  of  food  covered  by  this  Regulation, 
unless otherwise specified in this Regulation or non-legislative acts adopted pursuant 
to this Regulation. 

(26)  Currently,  the  statements  'gluten-free'  and  'very  low  gluten'  may  be  used  for  food 
intended for particular nutritional uses and for food for normal consumption under the 
rules  specified  in  Commission  Regulation  (EC)  No  41/2009  concerning  the 
composition and labelling of foodstuffs suitable for people intolerant to gluten20. Such 
statements  could  be  construed  as  nutrition  claims,  as  defined  in  Regulation  (EC)  No 
1924/2006. For the sake of simplification, those statements should be regulated solely 
by  Regulation  (EC)  No  1924/2006  and  comply  with  requirements  therein.  It  is 
necessary  that  technical  adaptations  pursuant  to  Regulation  (EC)  No  1924/2006, 
incorporating  the  nutrition  claims  'gluten-free'  and  'very  low  gluten'  and  their 
associated  conditions  of  use  as  regulated  under  Regulation  (EC)  No  41/2009  be 
completed prior to the entry into application of this Regulation.  

(27) 

'Meal  replacement  for  weight  control'  and  'total  diet  replacement  for  weight  control' 
are considered as food for particular nutritional uses and are governed by specific rules 
adopted  under  Directive  96/8/EC.  However,  more  and  more  food  intended  for  the 
general population has appeared on the market carrying similar declarations which are 

19 
20 

OJ L 404, 30.12.2006, p. 9. 
OJ L 14, 20.1.2009, p. 5. 

EN 

18 

   EN 

 
                                                 
presented  as  health  claims  for  weight  control.  In  order  to  eliminate  any  potential 
confusion  between  food  marketed  for  weight  control  and  in  the  interests  of  legal 
certainty  and  coherence  of  Union  legislation,  such  statements  should  be  regulated 
solely by Regulation (EC) No 1924/2006 and comply with requirements therein. It is 
necessary  that  technical  adaptations  pursuant  to  Regulation  (EC)  No  1924/2006, 
incorporating the health claims referring to the body weight control for food presented 
as  'total  diet  replacement  for  weight  control'  and  as  'meal  replacement  for  weight 
control'  and  associated  conditions  of  use  as  regulated  under  Directive  96/8/EC  be 
completed prior to the entry into application of this Regulation.  

(28)  Since the objectives of the actions to be taken cannot be sufficiently achieved by the 
Member  States  and  can  therefore  be  better  achieved  at  Union  level,  the  Union  may 
adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 
of the Treaty on European Union. In accordance with the principle of proportionality, 
as set out in that Article, this Regulation does not go beyond what is necessary in order 
to achieve those objectives. 

(29)  Adequate  transitional  measures  are  necessary  to  enable  food  business  operators  to 

adapt to the requirements of this Regulation.  

HAVE ADOPTED THIS REGULATION: 

CHAPTER I 
SUBJECT MATTER AND DEFINITIONS 

Article 1 
Subject matter  

1. 

This  Regulation  establishes  compositional  and  information  requirements  for  the 
following categories of food: 

(a) 

infant formula and follow-on formula; 

(b)  processed cereal-based food and baby food for infants and young children; 

(c) 

food for special medical purposes. 

2. 

This Regulation provides the rules for the establishment and update of a Union list 
of.  vitamins,  minerals  and  other  substances  that  can  be  added  to  the  categories  of 
food referred to in paragraph 1. 

Article 2 
Definitions 

1. 

For the purposes of this Regulation, the following definitions shall apply:  

(a) 

the  definitions  of  'food'  and  'placing  on  the  market'  set  out  in  Articles  2  and 
3(8) of Regulation (EC) No 178/2002; 

EN 

19 

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(b) 

(c) 

(d) 

the definitions of 'labelling' and 'pre-packaged foodstuff' in points (a) and (b) of 
Article 1(3) of Directive 2000/13/EC; 

the definitions of 'nutrition claim' and 'health claim' set out in points (4) and (5) 
of Article 2(2) of Regulation (EC) No 1924/2006; and,  

the definition of 'other substance' set out in Article 2(2) of Regulation (EC) No 
1925/2006. 

2. 

The following definitions shall also apply: 

(a) 

‘Authority’  means  the  European  Food  Safety  Authority  established  by 
Regulation (EC) No 178/2002; 

(b) 

‘infants’ means children under the age of 12 months; 

(c) 

‘young children' means children between one and three years; 

(d) 

(e) 

'infant formula' means food used 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; 

formula'  means 

'follow-on 
infants  when  appropriate 
food  used  by 
complementary  feeding  is  introduced  and  constituting  the  principal  liquid 
element in a progressively diversified diet of such infants; 

(f) 

'processed cereal-based food' means food  

(i) 

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 and 

(ii)  pertaining to the following four categories: 

– 

– 

– 

– 

simple  cereals  which  are  or  have  to  be  reconstituted  with  milk  or 
other appropriate nutritious liquids; 

cereals  with  an  added  high  protein  food  which  are  or  have  to  be 
reconstituted with water or other protein-free liquid; 

pastas which are to be used after cooking in boiling water or other 
appropriate liquids; 

rusks  and  biscuits  which  are  to  be  used  either  directly  or,  after 
pulverisation,  with  the  addition  of  water,  milk  or  other  suitable 
liquids; 

(g) 

'baby food' means 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: 

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(i) 

processed cereal-based food and 

(ii)  milk intended for young children; 

(h) 

'food  for  special  medical  purposes'  means  food  intended  for  the  dietary 
management of patients to be used under medical supervision. It is intended for 
the exclusive or partial feeding of patients with a limited, impaired or disturbed 
capacity to take, digest, absorb, metabolise or excrete ordinary food or certain 
nutrients  contained  therein,  or  with  other  medically-determined  nutrient 
requirements,  whose  dietary  management  cannot  be  achieved  only  by 
modification of the normal diet. 

3. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 15 to adapt the definitions of 'infant formula', 'follow-on formula', 'processed 
cereal-based food' and 'baby food' and 'food for special medical purposes' taking into 
account technical and scientific progress and relevant developments at international 
level, as appropriate.  

CHAPTER II 
PLACING ON THE MARKET  

Article 3 
Placing on the market  

Food  referred  to  in  Article  1(1)  may  be  placed  on  the  market  only  if  it  complies  with  the 
provisions of this Regulation.  

Article 4  
Pre-packaged food  

Food referred to in Article 1(1) shall only be allowed on the retail market in the form of pre-
packaged food. 

Article 5 
Free movement of goods 

Member States may not, for reasons related to their composition, manufacturing, presentation 
or  labelling,  restrict  or  forbid  the  placing  on  the  market  of  food  which  complies  with  this 
Regulation. 

Article 6 
Emergency measures  

1. 

Where  it  is  evident  that  a  food  referred  to  in  Article  1(1)  is  likely  to  constitute  a 
serious risk to human health and that such risk cannot be contained satisfactorily by 
means of measures taken by the Member State(s) concerned, the Commission on its 
own  initiative  or  at  the  request  of  a  Member  State,  shall  without  delay  take  any 
appropriate 
including  measures  restricting  or 
prohibiting  the  placing  on  the  market  of  the  food  concerned,  depending  on  the 
gravity of the situation. Those measures shall be adopted by means of implementing 
acts in accordance with the examination procedure referred to in Article 14(2).  

interim  emergency  measures, 

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2. 

3. 

1. 

2. 

On duly justified imperative grounds of extreme urgency to contain and/or address a 
serious  risk  to  human  health,  the  Commission  shall  adopt  immediately  applicable 
implementing acts in accordance with the procedure referred to in Article 14(3).  

Where  a  Member  State  officially  informs  the  Commission  of  the  need  to  take 
emergency  measures  and  the  Commission  has  not  acted  in  accordance  with 
paragraph  1,  the  Member  State  concerned  may  adopt  any  appropriate  interim 
emergency measures, restricting or prohibiting the placing on the market of the food 
concerned,  depending  on  the  gravity  of  the  situation,  within  its  territory.  It  shall 
immediately inform the other Member States and the Commission thereof, giving the 
grounds  for  its  decision.  The  Commission  shall  adopt  implementing  acts  aiming  at 
extending, amending or abrogating the national interim emergency measures. Those 
implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred  to  in  Article  14(2).  The  Member  State  may  maintain  its  national  interim 
emergency  measures  until  the  implementing  acts  mentioned  in  this  paragraph  have 
been adopted.  

CHAPTER III 
REQUIREMENTS 

SECTION 1 

INTRODUCTORY PROVISIONS 

Article 7 
Introductory provisions  

Food  referred  to  in  Article  1(1)  shall  comply  with  any  requirement  of  Union  law 
applicable to food. 

The  requirements  laid  down  in  this  Regulation  shall  prevail  over  any  other 
conflicting requirement of Union law applicable to food. 

Article 8 
Opinions of the Authority  

The  European  Food  Safety  Authority  shall  provide  scientific  opinions  in  accordance  with 
Articles  22  and  23  of  Regulation  (EC)  No  178/2002  for  the  purpose  of  application  of  the 
present Regulation. 

SECTION 2 
GENERAL REQUIREMENTS  

Article 9 
General composition and information requirements 

1. 

The composition of food referred to in Article 1(1) shall be such that it is appropriate 
to  satisfy  the  nutritional  needs  of,  and  it  is  suitable  for  the  persons  to  whom  it  is 
intended, in accordance with generally accepted scientific data.  

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2. 

3. 

4. 

1. 

2. 

Food referred to in Article 1(1) shall not contain any substance in such quantity as to 
endanger the health of the persons to whom they are intended. 

The  labelling,  presentation  and  advertising  of  food  referred  to  in  Article  1(1)  shall 
provide adequate consumer information and must not be misleading.  

The dissemination of  any  useful information or recommendations with reference to 
the  categories  of  food  referred  to  in  Article  1  (1)  may  be  made  exclusively  by 
persons having qualifications in medicine, nutrition, pharmacy or other professionals 
responsible for maternal and child health care.  

SECTION 3 
SPECIFIC REQUIREMENTS 

Article 10 
Specific composition and information requirements 

Food referred to in Article 1(1) must comply with the requirements of Article 7 and 
composition and information requirements provided in Article 9. 

Subject  to  the  general  requirements  of  Articles  7  and  9  and  taking  into  account 
Directive 2006/141/EC, Directive 2006/125/EC and Directive 1999/21/EC as well as 
any technical and scientific progress, the Commission shall be empowered to adopt 
delegated Regulations, no later than [2 years after the date of the entry into force of 
this Regulation], in accordance with Article 15, with respect to the following: 

(a) 

the specific compositional requirements of food referred to in Article 1(1); 

(b) 

(c) 

(d) 

(e) 

(f) 

the  specific  requirements  on  the  use  of  pesticides  in  agricultural  products 
intended  for  the  production  of  such  food  and  on  pesticides  residues  in  such 
food;  

the  specific  requirements  on  labelling,  presentation  and  advertising  of  food 
referred  to  in  Article  1(1),  including  the  authorisation  of  nutrition  and  health 
claims thereof; 

the notification procedure for the placing on the market of a food referred to in 
Article 1(1) in order to facilitate the efficient official monitoring of such food 
on the basis of which food operators shall notify the competent authority of the 
Member State(s) where the product is being marketed; 

the  requirements  on  promotional  and  commercial  practices  relating  to  infant 
formulae; and,  

the  requirements  on  information  to  be  provided  on  infant  and  young  child 
feeding  in  order  to  ensure  adequate  information  on  appropriate  feeding 
practices. 

3. 

Subject  to  the  requirements  of  Articles  7  and  9  and  taking  into  account  relevant 
technical  and  scientific  progress,  the  Commission  shall  update  the  delegated 
Regulations mentioned in paragraph 2 in accordance with Article 15.  

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Where  in  the  case  of  emerging  health  risks,  imperative  grounds  of  urgency  so 
require,  the  procedure  provided  in  Article  16  shall  apply  to  delegated  acts  adopted 
pursuant to this paragraph.  

CHAPTER IV 
UNION LIST OF PERMITTED SUBSTANCES 

Article 11 
Union list of permitted substances 

1. 

Vitamins, minerals, amino acids and other substances may be added to food referred 
to in Article 1(1), provided that such substances meet the following conditions:  

(a) 

they  do  not,  on  the  basis  of  the  scientific  evidence  available,  pose  a  safety 
concern to the health of the consumer; and, 

(b) 

they are available for use by the human body. 

2. 

3. 

No later than [2 years after the date of the entry into force of this Regulation], the 
Commission  shall  establish  and  subsequently  update  a  Union  list  of  permitted 
substances  that  meet  the  conditions  of  paragraph  1,  by  means  of  implementing 
Regulations. The entry of a substance in the Union list shall include a specification of 
the  substance,  and,  where  appropriate,  specify  the  conditions  of  use  and  the 
applicable  purity  criteria.  Those  implementing  Regulations  shall  be  adopted  in 
accordance  with  the  examination  procedure  referred  to  in  Article  14(2).  On  duly 
justified  grounds  of  extreme  urgency  relating  to  emerging  health  risks,  the 
Commission  shall  adopt  immediately  applicable  implementing  acts  updating  the 
Union list in accordance with Article 14(3). 

The entry of a substance in the Union list referred to in paragraph 2 may be initiated 
either on the initiative of the Commission or following an application. Applications 
may be made by a Member State or by an interested party, who may also represent 
several interested parties (hereinafter referred to as the applicant). Applications shall 
be sent to the Commission, in accordance with paragraph 4.  

4. 

The application shall include:  

(a) 

the name and the address of the applicant; 

(b) 

the name and a clear description of the substance  

(c) 

the composition of the substance; 

(d) 

the proposed use of the substance and conditions thereof; 

(e) 

a  systematic  review  of  the  scientific  data  and  appropriate  studies  performed 
following  generally  accepted  expert  guidance  on  the  design  and  conduct  of 
such studies; 

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(f) 

scientific evidence demonstrating the quantity of the substance which does not 
endanger the health of the persons to whom it isintended and its suitability for 
the intended uses; 

(g) 

scientific evidence demonstrating that the substance is available for use by the 
human body;  

(h) 

a summary of the content of the application. 

When  a  substance  is  already  included  in  the  Union  list  and  there  is  a  significant 
change in the production methods, or there is a change in particle size, for example 
through  nanotechnology,  the  substance  prepared  by  those  new  methods  shall  be 
considered  as  different  substance  and  the  Union  list  shall  be  modified  accordingly 
before it can be placed on the Union market. 

Article 12 
Confidential information relating to applications 

Among  the  information  provided  in  the  application  referred  to  in  Article  11, 
confidential  treatment  may  be  given  to  information  the  disclosure  of  which  might 
significantly harm the competitive position of the applicant.  

Information relating to the following shall not, in any circumstances, be regarded as 
confidential: 

(i) 

the name and address of the applicant; 

(ii) 

the name and description of the substance; 

(iii) 

the justification for the use of the substance in or on specific food; 

(iv) 

information that is relevant to the assessment of the safety of the substance; 

(v)  where applicable, the analysis method(s) used by the applicant.  

Applicants shall indicate which of the information provided they wish to be treated 
as confidential. Verifiable justification must be given in such cases. 

The Commission shall decide after consulting with the applicants which information 
can  remain  confidential  and  shall  notify  applicants  and  the  Member  States 
accordingly. 

After  being  made  aware  of  the  Commission’s  position,  applicants  shall  have  three 
weeks in which to withdraw their application so as to preserve the confidentiality of 
the information provided. Confidentiality shall be preserved until this period expires. 

5. 

1. 

2. 

3. 

4. 

5. 

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CHAPTER V 
CONFIDENTIALITY  

Article 13 
General confidentiality clause 

The Commission, the Authority and the Member States shall, in accordance with Regulation 
(EC) No 1049/2001, take the necessary measures to ensure appropriate confidentiality of the 
information  received  by  them  under  this  Regulation,  except  for  information  which  must  be 
made public if circumstances so require in order to protect human health, animal health or the 
environment.  

CHAPTER VI 
PROCEDURAL PROVISIONS 

Article 14 
Committee 

1. 

2. 

The Commission shall be assisted by the Standing Committee on the Food Chain and 
Animal  Health.  That  committee  shall  be  a  committee  within  the  meaning  of 
Regulation (EU) No 182/2011. 

Where  reference  is  made  to  this  paragraph,  Article  5  of  Regulation  (EU) 
No 182/2011 shall apply. 

Where  the  opinion  of  the  committee  is  to  be  obtained  by  written  procedure,  that 
procedure shall be terminated without result when, within the time-limit for delivery 
of  the  opinion,  the  chair  of  the  committee  so  decides  or  a  simple  majority  of 
committee members so request.  

3. 

Where  reference  is  made  to  this  paragraph,  Article  8  of  Regulation  (EU) 
No 182/2011, in conjunction with Article 5 thereof, shall apply.  

Article 15 
Exercise of the delegation 

1. 

2. 

3. 

The  power  to  adopt  delegated  acts  is  conferred  on  the  Commission  subject  to  the 
conditions laid down in this Article.  

The delegation of power referred to in Articles 2(3) and 10 of this Regulation shall 
be conferred for an indeterminate period of time from the (*) [(*) Date  of  entry  into 
force of the basic legislative act or from any other date set by the legislator.] 

The delegation of powers referred to in Articles 2(3) and 10 of this Regulation may 
be revoked at any time by the European Parliament or by the Council. A decision of 
revocation shall put an end to the delegation of the power specified in that decision. 
It  shall  take  effect  the  day  following  the  publication  of  the  decision  in  the  Official 

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Journal of the European Union or at a later date specified therein. It shall not affect 
the validity of any delegated acts already in force.  

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council.  

A  delegated  act  adopted  pursuant  to  Articles  2(3)  and  10  of  this  Regulation  shall 
enter  into  force  only  if  no  objection  has  been  expressed  either  by  the  European 
Parliament or the Council within a period of 2 months of notification of that act to 
the European Parliament and the Council or if, before the expiry of that period, the 
European Parliament and the Council have both informed the Commission that they 
will  not  object.  That  period  shall  be  extended  by  2  months  at  the  initiative  of  the 
European Parliament or the Council. 

Article 16 
Urgency procedure  

Delegated  acts  adopted  under  this  Article  shall  enter  into  force  without  delay  and 
shall apply as long as no objection is expressed in accordance with paragraph 2. The 
notification  of  a  delegated  act  to  the  European  Parliament  and  to  the  Council  shall 
state the reasons for the use of the urgency procedure. 

Either  the  European  Parliament  or  the  Council  may  object  to  a  delegated  act  in 
accordance  with  the  procedure  referred  to  in  Article  15.  In  such  a  case,  the 
Commission  shall  repeal  the  act  without  delay  following  the  notification  of  the 
decision to object by the European Parliament or the Council. 

CHAPTER VII 
FINAL PROVISIONS 

Article 17 
Repeal 

Directive  92/52/EEC  and  Directive 2009/39/EC  are  repealed  from  [the  first  day  of 
the  month  2  years  after  the  date  of  the  entry  into  force  of  this  Regulation]. 
References to the repealed acts shall be construed as references to this Regulation. 

Directive 96/8/EC and Regulation (EC) No 41/2009 are repealed from [the first day 
of the month 2 years after the date of the entry into force of this Regulation].  

4. 

5. 

1. 

2. 

1. 

2. 

Article 18 
Transitional measures 

Food  not  complying  with  this  Regulation  but  complying  with  Directives 2009/39/EC  and 
96/8/EC, Regulations (EC) No 41/2009 and (EC) No 953/2009, and labelled prior to [2 years 
after the date of the entry into force of this Regulation] may continue to be marketed after that 
date until stocks are exhausted.  

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Article 19 
Entry into force 

This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

It shall apply from [the first day of the month 2 years after the entry into force], 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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