COMMISSION STAFF WORKING PAPER 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: Directorate-General for Health and Consumers, European Commission
Subjects: baby food, care of mothers and infants, early childhood, health care, human nutrition

EUROPEAN COMMISSION 

Brussels, 20.6.2011 
SEC(2011) 763 final 

COMMISSION STAFF WORKING PAPER 

SUMMARY OF THE 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 

[Previously known as the Summary of the Impact Assessment accompanying document 
to the Proposal to revise the Dietetic Food Framework Legislation] 

{COM(2011) 353 final} 
{SEC(2011) 762 final} 

 
 
 
 
  
 
 
1.  PROBLEM DEFINITION 

Foods for particular nutritional uses or 'dietetic' foods 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  e.g.  foods  for 
infants and young children, medical foods, foods for weight reduction, gluten-free foods etc. 
The dietetic food legislation was implemented since 1977 in order to ensure free movements 
of goods and prevent unequal conditions of competition. 

It consists of a Framework Directive1 and specific measures adopted for certain categories of 
foods: 

- Infant formulae and follow-on formulae2;  

- Processed cereal-based foods and baby foods for infants and young children (baby foods)3;  

- Foods intended for use in energy-restricted diets for weight reduction (slimming foods)4; 

- Foods for special medical purposes (medical foods)5;  

- Foods for people intolerant to gluten (gluten-free foods)6.  

Due  to  diversification  and  specialisation  of  foods  over  the  last  decades,  new  pieces  of 
legislation have been adopted. Of particular importance in this context are the legislation on 
food supplements7, fortified foods8 and nutrition and health claims9.  

Discussions with Member States and stakeholders have highlighted difficulties relating to the 
implementation of the dietetic food legislation and its interaction with more recent pieces of 
legislation. The main problems identified relate to the following issues. 

'Dietetic' food or 'normal' food 

As  the  development  of  food  and  its  marketing  is  becoming  more  and  more  targeted  to 
specific  categories  of  consumers  (e.g.  fortified  foods  for  children,  food  supplements  for 
pregnant women, fortified food to boost the immune system etc.), it could be argued that a 
vast number of products on the market today are developed/aimed for a certain group of the 
population  with  specific  nutritional  needs.  It  is  sometimes  more  and  more  difficult  to  see 
where  that  distinction  between  'normal'  foods  intended  for  the  'general'  population  and 
'dietetic' foods intended for a 'specific' group of the population lies. 

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9 

OJ L 124, 6.5.2009, p. 21. 
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. 5. 
OJ L 183, 12.7.2002, p. 51–57. 
OJ L 404, 30.12.2006, p. 26–38. 
OJ L 404, 30.12.2006, p. 9–25. 

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Understanding the interaction – 'dietetic' suitability statement or claim? 

When the framework legislation was adopted, in December 1976, the compulsory 'dietetic' 
suitability  statement  foreseen  on  the  label  of  dietetic  foods  was  intended  to  cover  a  large 
scope and was not limited to defined information. Following the adoption of the Nutrition 
and  Health  Claims  Regulation  in  2006,  which  covers  all  statements  made  on  foods 
implying a nutrition and/or a health benefit, the interaction between the different pieces of 
legislation  becomes  less  clear.  Today,  in  cases  where  no  further  rules  have  been  set  in 
specific pieces of legislation, the indication of 'dietetic' suitability, as eroded by the Claims 
Regulation, would be restricted to the indication of the group of the population to whom the 
food is intended. 

Legislation shopping  

Member States have reported10 that the legislation on dietetic foods is being used by some 
operators to  circumvent the rules of  legislation adopted subsequently to it, thus distorting 
the notion of a food for particular nutritional uses and resulting in certain cases in confusion 
over its application.  

It appears that some operators notify under the dietetic food legislation a 'normal' food in 
order to be able to use a 'dietetic' suitability statement (mandatory according to the dietetic 
food legislation) instead of the equivalent claim and therefore avoid the requirements of the 
claims  Regulation  (EU  prior-authorisation  with  scientific  assessment).  This  possibility 
distorts  the  market  and  results  in  an  uneven  playing  field  for  food  operators  and  unfair 
competition, as some businesses can gain an unfair advantage over a competitor by using a 
dietetic food statement instead of having the same claim authorized. This is particularly true 
for the potential dietetic foods that are subject to the notification procedure or for which no 
specific rules have been laid down.  

Concrete examples of distortions: 

Between Member States and businesses 

•  Some Member States will consider that a food marketed as 'food suitable for people with 
digestion  disorders'  is  a  'normal'  food  bearing  a  claim  under  the  Nutrition  and  Health 
Claims  legislation  and  request  it  be  subject  to  EU  prior-authorisation.  Other  Member 
States  will  consider  it  as  a  'dietetic'  food  that  should  be  notified  at  national  level.  A 
business operating in different Member States may therefore have to comply for the same 
product with different rules depending on the competent authorities' interpretation of the 
legislation  

For consumers 

•  A  consumer  might  pay  more  for  a  'dietetic  chocolate  suitable  for  diabetic  people' 
considered  as  being  specially  formulated  for  diabetic  people  than  for  a  similar  'normal' 
chocolate bearing a nutrition claim "low in sugar".  

10 

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. 

2

 
 
                                                 
Stakeholders most affected 

The  proposal  will  have  a  direct  impact  on  specialised  dietetic  food  producers  and  Member 
States  competent  authorities  and  an  indirect  impact  on  general  EU  food  producers  and 
consumers. 

Intervention necessary 

After  more  than  30  years  of  existence  of  the  Framework  Directive  on  dietetic  foods,  this 
revision is also an opportunity to simplify the legal framework, reduce administrative burden 
whenever  possible  and  to  facilitate  innovation  as  well  as  to  only  intervene  when  EU  action 
provides substantial added value over individual Member States action. 

2.  ANALYSIS OF SUBSIDIARITY 

The Framework Directive was based on Article 100a of the EC Treaty, now become Article 
114 of the Treaty on the Functioning of the European Union (TFEU) and aims at establishing 
an  internal  market  for  dietetic  foods  products  while  ensuring  a  high  level  of  protection  of 
consumers. 

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 
were adopted at EU level. 

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

3.  POLICY OBJECTIVES 

Overall objectives: 

The main aim of the revision is to ensure appropriate consumer information for specific 
foods and good functioning of the internal market within the context of the Commission's 
commitment  to  smart  regulation  (proportionality,  reduction  of  burden,  legal  clarity,  and 
better enforcement) for Member States and businesses.  

Specific objectives:  

•  Objective  1:  Coherence  –  To  remove  the  difference  in  interpretation  and  difficulty  in 
implementation  of  the  dietetic  food  legislation  given  the  development  of  other  food 
legislation  and  to  appropriately  coordinate  and  align  rules  for  specific  foods  with  other  
food legislation 

•  Objective  2:  Simplification  –  To  remove  the  rules  that  have  become  unnecessary, 
contradictory  and  potentially  conflicting  and  to  reduce  the  administrative  burden 
associated with the implementation of the legislation. 

•  Objective 3: Harmonisation – To ensure that similar products are treated in the same way 
across the Union and to allow the free movement and equal conditions of competitions for 
goods. 

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•  Objective  4:  Small  Businesses  and  Innovation  –  To  ensure  that  any  change  to  the 
management  of  foods  currently  covered  by  the  Framework  Directive  does  not  impact 
disproportionately on small businesses (as they have limited capacities to invest additional 
resources  in  obtaining  external  legal  expertise  to  understand  the  legislation)  or  place 
unnecessary additional burdens on food businesses operators that may hinder innovation. 

4.  POLICY OPTIONS 

Different  policy  options  can  be  identified  in  order  to  achieve  each  of  the  four  objectives 
described in section 3:  

•  Option  1 – Repeal all the legislation on dietetic foods (Framework Directive and all the 

specific Directives adopted under that Framework) 

•  Option 2 – Repeal the Framework Directive on dietetic food but maintain certain of the 

specific rules adopted under that Framework  

•  Option  3  –  Revise  the  Framework  Directive  establishing  a  positive  list  of  dietetic  foods 

with specific compositional and/or labelling rules 

•  Option 4 – Amend the Framework Directive replacing the notification procedure with EU 

centralised prior-authorisation procedure based on a scientific assessment.  

5.  ASSESSMENT OF IMPACTS 

In  order  to  undertake  the  impact  assessment  a  range  of  potential  impacts  were  identified 
through consultation with Member States and stakeholders. This Impact Assessment analyses 
the  likely  social,  economic  and  environmental  impacts  –  be  they  direct  or  indirect  –  of  the 
different  policy  options.  As  the  Framework  legislation  on  dietetic  food  was  established  to 
ensure good functioning of the internal market the major focus of the analysis is on economic 
impacts  of  the  options  (administrative  burden,  reformulation  and  labelling,  innovation, 
competitiveness  and  price)  rather  than  social  costs  (e.g.  public  health).  However,  as  in  some 
areas there could be such potential social impacts - consumer protection and information and 
loss of employment – and, these have been where possible assessed. The loss of employment 
has  been  identified  under  the  economic  impacts  sections  in  particular  when  considering  the 
impact  on  SMEs.  The  wider  social  analysis  of  the  four  options  could  not  find  any  other 
significant impacts particularly on social wellbeing. The assessment of each option in terms of 
environmental impacts has not identified significant impacts (either negative or positive). 

Summary of impacts: 

Positive Impacts of Each Policy Option

Negative Impacts of Each Policy Option

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option 1

option 2

option 3

option 4

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Economic 

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Economic 

option 1

option 2

option 3

option 4

 
 
 
 
 
 
Option 1 

Abolishing the concept of dietetic food will prevent further distortions between dietetic foods 
and 'normal' foods with claims. However, whilst this appears to be a good option 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 EU legislation related for example to 
foods intended to infants and young children may be significant.  

Option 2 

Option  2  provides  the  same  simplification  and  administrative  burden  reduction  benefits  as 
option 1 but also gives the EU the possibility to maintain for certain categories of foods, rules 
the harmonisation of which has provided added value at European 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 

The main advantage of setting a positive list for dietetic foods with specific compositional and 
labelling  requirements  is  that  standardised  rules  would  apply  to  the  dietetic  foods  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 foods 
legislation  to  be  able  to  target  foods  to  certain  groups  of  the  population  may  be  considered 
disproportionate  particularly  taking  into  account  the  minimal  additional  public  health  and 
consumer information benefits.  

Option 4 

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  obtaining  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. 

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6.  COMPARISON OF OPTIONS  

Option 1  Option 2  Option 3  Option 4 

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Nutritional quality for the intended use 

- - 

Consumer Information 

Internal Market Function 

Coherence  

- remove difference in interpretation 

- coordinate and align with other rules 

Simplification 

- remove unnecessary rules 

- reduce administrative burden 

Harmonisation 

- 

- 

+ + 

+ + 

+ + 

+ + 

+ + 

+ + 

+ 

+ 

+ 

+ + 

+ 

+ + 

+ 

+ + 

+ 

- 

- - 

+ 

- to ensure that similar products are treated 
in the same way across the union 

- - 

+ + 

++ 

SMEs and Innovation 

- no disproportionate impact on SMEs 

- clear and simple rules to prevent barriers 
to innovate 

+ 

+ 

+ 

- 

+ + 

+ - 

Magnitude of impact of the criteria compared: ++ strongly positive; + positive, -- strongly negative, - negative 

+ + 

+ 

+ + 

+ 

+ 

-- 

-- 

+ 

-- 

-- 

The  impacts  of  the  options  considering  the  repeal  of  the  dietetic  food  legislation  (options  1 
and 2) were estimated mainly as being positive with regard to the objectives of the revision - 
coherence  and  simplification  of  the  legislation,  harmonised  intra-union  trade  and  growth  of 
the  markets  and  taking  into  account  SMEs.  However,  these  positive  impacts  would  be 
counter-balanced by the loss of harmonised rules for products intended to vulnerable groups 
of the population. Therefore, specific legislation for categories of foods for which the lack of 
additional compositional and labelling rules to the general rules could compromise nutritional 
safety should be maintained. 

The  options  of  maintaining  and  reinforcing  the  legislation  on  dietetic  foods  (option  3:  by 
maintaining  and  establishing  specific  rules  or  option  4:  by  imposing  a  prior-authorisation 
regime to all dietetic foods) were considered as placing on industry, Member States and the 
Commission  disproportionate  burdens 
in 
comparison  to  the  benefit  to  public  health  and  consumer  information.  In  addition,  third 
country trade might be affected by additional requirements and such approach would close the 
sector and restrict competitiveness (especially for SMEs). 

(administrative,  operational,  enforcement) 

6

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Preferred option 

It is concluded that the revision of the legislation should be done in accordance with option 2 
assuming  that  the  maintenance  of  separate  legislation  on  dietetic  foods  in  addition  to  other 
existing rules of food legislation is no longer justified in the current food market.  

In line with the Commission's Smart Regulation policy, option 2 offers the best approach to 
simplification,  clarity,  coherence  and  reduction  of  administrative  burden  without  losing 
harmonisation that has proved beneficial at EU level in terms of consumer nutritional safety 
and internal market functioning. 

Removing the concept of dietetic food would prevent differences in interpretation, as all foods 
will be considered in the same way by general legislation. However, the analysis of option 2 
demonstrates  that  certain  rules  established  under  the  specific  pieces  of  dietetic  foods 
legislation  should  be  maintained  when  it  is  considered  that  the  general  labelling  and  safety 
rules are not sufficient to ensure adequate nutritional composition of the food to protect the 
most vulnerable consumers and appropriate consumer information across the Member States 
(e.g. foods intended to infants and young children and medical foods). 

7.  MONITORING AND EVALUATION 

A set of indicators and data to be collected was proposed to enable future measurement of the 
economic and social impact of initiative. 

7