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
Date: 2008-06-27
Institutions: European Commission
Subjects: approximation of laws, baby food, dietary product, exchange of information, foodstuff, foodstuffs legislation

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 27.6.2008 
COM(2008) 393 final 

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 

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TABLE OF CONTENTS 

1. 

1.1. 

1.2. 

2. 

Introduction .................................................................................................................. 4 

Purpose and scope of Directive 89/398/EEC and of Article 9..................................... 5 

Evolution of the legal framework ................................................................................ 6 

Notifications reported by the Member States............................................................... 7 

2.1. 

Details by individual Member State............................................................................. 8 

2.1.1.  Austria .......................................................................................................................... 8 

2.1.2.  Belgium ........................................................................................................................ 8 

2.1.3.  Cyprus .......................................................................................................................... 8 

2.1.4.  Czech Republic ............................................................................................................ 8 

2.1.5.  Denmark....................................................................................................................... 8 

2.1.6.  Estonia.......................................................................................................................... 9 

2.1.7.  Finland.......................................................................................................................... 9 

2.1.8.  France........................................................................................................................... 9 

2.1.9.  Germany..................................................................................................................... 10 

2.1.10.  Greece ........................................................................................................................ 11 

2.1.11.  Hungary...................................................................................................................... 12 

2.1.12.  Ireland ........................................................................................................................ 12 

2.1.13.  Italy ............................................................................................................................ 12 

2.1.14.  Latvia.......................................................................................................................... 12 

2.1.15.  Lithuania .................................................................................................................... 13 

2.1.16.  Luxembourg ............................................................................................................... 13 

2.1.17.  Malta .......................................................................................................................... 13 

2.1.18.  The Netherlands ......................................................................................................... 13 

2.1.19.  Poland......................................................................................................................... 13 

2.1.20.  Portugal ...................................................................................................................... 13 

2.1.21.  Slovak Republic ......................................................................................................... 14 

2.1.22.  Slovenia...................................................................................................................... 14 

2.1.23.  Spain........................................................................................................................... 14 

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2.1.24.  Sweden ....................................................................................................................... 14 

2.1.25.  United Kingdom......................................................................................................... 15 

3. 

4. 

Discussion .................................................................................................................. 15 

Conclusion.................................................................................................................. 18 

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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 

1. 

INTRODUCTION 

In accordance with Article 9, paragraph 5 of Council Directive 89/398/EEC of 3 May 
1989  on  the  approximation  of  the  laws  of  the  Member  States  relating  to  foodstuffs 
intended for particular nutritional uses1 (dietetic foods), the European Commission is 
required  to  send  a  report  to  the  European  Parliament  and  the  Council  on  the 
implementation of Article 9 of the Directive. 

In 1994, the Commission sent to the Council a report on this issue (COM (94)475) 
under the original provisions of Article 9(5) of the Directive. The report covered the 
notifications received from the entry into force of the Directive in 1989 up to 1994. 

In  1999,  Directive  1999/41/EC2  amended  the  provisions  of  Article  9(5),  requiring 
regular  reports  on  the  implementation  of  the  Article  to  be  sent  to  the  European 
Parliament and the Council.  

To  enable  the  Commission  to  report  on  the  implementation  of  this  Article,  the 
Member States were asked in 2002 and 2006 by the Commission services to provide 
information on: 

1. 

The  number  of  food  products  that  have  been  notified  under Article  9  to  their 
competent authority.  

2.  Details of the particular nutritional uses of the notified products.  

The Member States were asked to indicate, when possible, if the notifications were 
related to the first time of placing a product on the market or if the products had been 
previously notified in another Member State. 

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2 

OJ L 186, 30.6.1989, p. 27–32. 
Directive  1999/41/EC  of  the  European  Parliament  and  of  the  Council  of  7  June  1999  amending 
Directive  89/398/EEC  on  the  approximation  of  the  laws  of  the  Member  States  relating  to  foodstuffs 
intended for particular nutritional uses. OJ L 172, 8.7.1999, p. 38–39. 

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Additionally,  comments  on  the  experience  of  implementing  the  provisions  of 
Article 9 within the country and the functioning of these provisions of the Directive 
were welcomed.  

This report integrates the information provided by Member States in 2002 and 2006 
and covers reported notifications received by Member States up to the end of 2005. 
This  time  limit  was  requested  by  the  Commission  services.  However,  subsequently 
the preparation of the report was coupled with the preparation of the report on foods 
for  people  with  carbohydrate-metabolism  disorders  (diabetes)  and  the  reflection  on 
the  need  for  a  global  revision  of  Directive  89/398/EEC  (including 
the 
implementation of Article 9). Such overall consideration of the issues took more time 
than expected but allowed for a more complete overview of the relevant sector. 

1.1. 

Purpose and scope of Directive 89/398/EEC and of Article 9 

to 

Directive 89/398/EEC concerns foodstuffs for particular nutritional uses, also called 
dietetic  foods.  Article  1  of  the  Directive  states  that  these  are  "foodstuffs  which, 
owing 
their  special  composition  or  manufacturing  process,  are  clearly 
distinguishable from foodstuffs for normal consumption, which are suitable for their 
claimed  nutritional  purposes  and  which  are  marketed  in  such  a  way  as  to  indicate 
such suitability."  

The  Article  states  also  that  a  particular  nutritional  use  must  fulfil  the  particular 
nutritional requirements:  

(1)  of  certain  categories  of  persons  whose  digestive  processes  or  metabolism  are 

disturbed; or 

(2)  of  certain  categories  of  persons  who  are  in  a  special  physiological  condition 
and  who  are  therefore  able  to  obtain  special  benefit  from  controlled 
consumption of certain substances in foodstuffs; or 

(3)  of infants or young children in good health. 

Annex I of the Directive contains a list of groups of foods for particular nutritional 
uses  for  which  specific  provisions  will  be  laid  down  by  specific  Directives.  The 
foodstuffs intended for a particular nutritional use which do not belong to one of the 
groups listed in Annex I are covered by the provisions of Article 9. 

Article 9 specifies that: 

"To  permit  efficient  official  monitoring  of  foodstuffs  intended  for  a  particular 
nutritional  use  which  do  not  belong  to  one  of  the  groups  listed  in  Annex  I,  the 
following specific provisions shall apply: 

1.  When a product as referred to above is placed on the market for the first time 
the  manufacturer  or,  where  a  product  is  manufactured  in  a  third  State,  the 
importer, shall notify the competent authority of the Member State where the 
product  is  being  marketed  by  forwarding  it  a  model  of  the  label  used  for  the 
product.  

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2.  Where  the  same  product  is  subsequently  placed  on  the  market  in  another 
Member  State  the  manufacturer  or,  where  appropriate,  the  importer  shall 
provide  the  competent  authority  of  that  Member  State  with  the  same 
information, together with an indication of the recipient of the first notification.  

3.  Where  necessary,  the  competent  authority  shall  be  empowered  to  require  the 
manufacturer  or,  where  appropriate,  the  importer,  to  produce  the  scientific 
work  and  the  data  establishing  the  product's  compliance  with  Article  1(2) 
together  with  the  information  provided  for  in  Article  7(3)(a).  If  such  work  is 
contained in a readily available publication, a mere reference to this publication 
shall suffice." 

The purpose of Article 9 of Directive 89/398/EEC is to permit the official monitoring 
of foodstuffs intended for particular nutritional uses that do not belong to the groups 
of  foodstuffs  listed  in  Annex  I  of  the  Directive,  for  which  specific  Directives  have 
been or will be developed.  

1.2. 

Evolution of the legal framework 

Initially, in 1989, Annex I listed nine groups of foodstuffs:  

1. 

2. 

3. 

4. 

Infant formulae 

Follow-up milk and other follow-up foods 

Baby foods 

Low-energy and energy-reduced foods intended for weight control 

5.  Dietary foods for special medical purposes 

6. 

Low-sodium foods, including low-sodium or sodium-free dietary salts 

7.  Gluten-free foods 

8. 

9. 

Foods  intended  to  meet  the  expenditure  of  intense  muscular  effort,  especially 
for sportsmen 

for  persons  suffering 

Foods 
(diabetes). 

from  carbohydrate-metabolism  disorders 

That  Annex  was  amended  by  Directive  1999/41/EC  and  two  groups  of  foodstuffs 
were deleted: low-sodium foods, including low-sodium or sodium-free dietary salts, 
and gluten-free foods. 

Articles 4a and 4b were added to Directive 89/398/EEC. Article 4a states that rules 
for the use of terms concerning the reduction or absence of sodium or salt (sodium 
chloride,  table  salt)  content,  and  the  absence  of  gluten,  shall  be  adopted  through  a 
comitology procedure. 

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Article  4b  states  that,  regarding  foods  for  persons  suffering  from  carbohydrate-
metabolism  disorders  (diabetes),  the  Commission  shall,  in  accordance  with  the 
comitology  procedure,  either  proceed  with  the  preparation  of  special  provisions  or 
present any appropriate proposals for amending the Directive. 

The current version of the Annex reads: 

– 

"Groups  of  foodstuffs  for  particular  nutritional  uses  for  which  specific 
provisions will be laid down by specific Directives: 

1. 

2. 

Infant formulae and follow-on formulae3 

Processed  cereal-based  foods  and  baby  foods  for  infants  and  young 
children4 

3. 

Food intended for use in energy-restricted diets for weight reduction5 

4.  Dietary foods for special medical purposes6 

5. 

Foods  intended  to  meet  the  expenditure  of  intense  muscular  effort, 
especially for sportsmen7; 

– 

Groups  of  foodstuffs  for  particular  nutritional  uses  for  which  specific 
provisions will be laid down by a specific Directive, dependent on the outcome 
of the procedure described in Article 4b: 

6. 

Foods  for  persons  suffering  from  carbohydrate-metabolism  disorders 
(diabetes).7" 

2. 

NOTIFICATIONS REPORTED BY THE MEMBER STATES 

This  section  summarises  the  information  on  notifications  of  dietetic  foods  that  are 
not listed in Annex I of Directive 89/398/EEC. Therefore, categories of foods listed 
in Annex I are in principle not taken into account. However, due to different ways of 
reporting and transposing the legislation, it has not always been possible to make this 
distinction  and  to  extract  the  exact  number  of  notifications  of  dietetic  foods  falling 
within the scope of Article 9 from the total communicated. 

The  starting  date  for  reception  of  the  notifications  varies  from  country  to  country, 
due  to  differences  in  the  time  taken  to  apply  the  necessary  procedures  through 
national legislation. 

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Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae 
and amending Directive 1999/21/EC. OJ L 401, 30.12.2006, p. 1–33. 
Commission  Directive  2006/125/EC  of  5  December  2006  on  processed  cereal-based  foods  and  baby 
foods for infants and young children (Codified version). OJ L 339, 6.12.2006, p. 16–35. 
Commission Directive 96/8/EC of 26 February 1996 on foods intended for use in energy-restricted diets 
for weight reduction. OJ L 55, 6.3.1996, p. 22–26. 
Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes. OJ 
L 91, 7.4.1999, p. 29–36. 
No specific directives have been adopted yet. 

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For countries that joined the European Union on 1 May 2004, the period taken into 
consideration starts from 1 May 2004, the date of accession.  

Data  from  Bulgaria  and  Romania  are  not  included  in  the  report  as  it  covers 
notifications received until the end of 2005. 

2.1. 

Details by individual Member State 

2.1.1.  Austria 

A total of 128 notifications have been received by the Austrian competent authority. 
The notified foods are described as: 

– 

– 

– 

– 

– 

foods for persons suffering from celiac disease - gluten-free foods (92), 

foods for persons suffering from phenylketonuria (12),  

foods for pregnant or breast-feeding (lactating) women (10),  

foods for premature infants and carbohydrate-substitution after birth; enriched 
mother milk for pre-term infants (10),  

foods for persons suffering from hypercholesterolemia (6). 

2.1.2.  Belgium 

One product has been notified to the Belgian competent authority. The request was 
for  a  “diet  honey”,  a  product  containing  60%  sweeteners,  for  the  replacement  of 
honey  for  people  who  suffer  from  diabetes.  It  was  not  accepted,  because  it  was 
considered not to be in line with Council Directive 2001/110/EC relating to honey. 
However,  it  has  to  be  noted  that,  as  mentioned  above,  foods  for  persons  suffering 
from  diabetes  are  not  currently  subject  to  the  notification  procedure  laid  down  in 
Article 9. 

2.1.3.  Cyprus 

No  notification  has  been  received  by  the  competent  authority  of  the  Republic  of 
Cyprus. 

2.1.4.  Czech Republic 

No notification has been received by the competent authority of the Czech Republic. 

2.1.5.  Denmark 

A  total  of  36  notifications  have  been  received  by  the  Danish  competent  authority. 
The notified foods are described as: 

– 

low-protein foods (19), 

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– 

– 

– 

very low-calorie diet foods (9), 

lactose-free foods (5), 

gluten-free foods (3). 

2.1.6.  Estonia  

A total of 19 notifications have been received by the Estonian competent authority. 
The notified foods have been described as: 

– 

– 

gluten-free foods (18), 

low-sodium foods (1). 

Placing  on  the  market:  The  marketing  of  three  of  these  foods  had  already  been 
notified in other Member States before notification in Estonia. 

2.1.7.  Finland 

A total of 350 notifications have been received by the Finnish competent authority. 
The notified foods are described as: 

– 

– 

– 

– 

low-lactose or lactose-free foods (201), 

gluten-free foods (131), 

cholesterol-lowering foods (17), 

low-protein foods (1). 

Note: Around 17% of the Finnish population suffer from lactose intolerance. For that 
reason  the  dairy  industry  has  developed  several  milk  products  that  are  suitable  for 
this population group.  

Placing on the market: All the notified products were placed on the market for the 
first time in Finland.  

2.1.8.  France 

A  total  of  92  notifications  have  been  received  by  the  French  competent  authority. 
The notified foods are described as: 

– 

– 

– 

– 

low-calorie food, not covered by specific legislation on weight reduction (34), 

high-protein and low-calorie foods (8), 

fortified foods for children and adolescents (cereals, biscuits and milk drinks) 
(46), 

fortified foods for seniors (milk drinks and biscuits) (2), 

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– 

– 

powder milk-based food for convalescents (1), 

gluten-free foods (1). 

Note: No information has been received for the period 2002-2005. 

Placing on the market: The French authority states that in general, no information is 
provided  about  whether  or  not  the  product  has  been  notified  in  another  Member 
State. 

2.1.9.  Germany 

A total of 338 notifications have been received by the German competent authority. 

Out  of  that  total,  119  notifications  (35%)  were  found  to  be  suitable  for  dietary 
purposes and in conformity with the legal provisions. The notified foods (including 
27 products for which the procedure is still ongoing) are described as:  

– 

– 

– 

– 

– 

– 

– 

Foods  for  hypercholesterolemics  and/or  persons  requiring  fat-modified  food 
(46) 

Foods for pregnant women and/or breastfeeding mothers (30) 

Foods for persons suffering from an absorption or digestion disorder and diet-
related nutrient deficiency (20) 

Foods for persons with an iron deficiency (14) 

Foods for persons requiring protein-modified food (in particular phenylalanine-
low foodstuffs) (12) 

Foods for persons with a deficiency in specific amino acids (11) 

Foods  for  persons  with  a  deficiency  in  certain  mineral  substances  (other  than 
iron) (7) 

– 

Other (6) 

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128 notifications (38%) were not accepted because of, for example, the absence of an 
objective designation of a particular consumer group, the mention of conditions not 
requiring  nourishment  with  specially  formulated  dietary  foods  (climacterium, 
migraine,  age,  stress,  need  to  build  up  resistance,  etc.)  and/or  a  lack  of  marked 
differences  compared  with  foodstuffs  for  normal  consumption,  such  as  food 
supplements8  or  foods  to  which  vitamins,  minerals  or  other  substances  have  been 
added9 ("fortified foods"). In addition some products were mainly intended for non-
nutritive  purposes,  so  that  classification  as  a  medicinal  product  could  not  be  ruled 
out.  

For  49  notifications  the  procedure  is  still  ongoing,  e.g.  due  to  court  proceedings 
pending  or  the  not  yet  completed  examination.  Furthermore,  42  products  were 
unnecessarily  notified  as  they  belong  to  categories  of  food  included  in  Annex  I  of 
89/398/EEC.  

Notes:  National  provisions  exempt  the  following  groups  of  dietetic  foods  from  the 
notification procedure laid down in Article 9: 

– 

– 

low-sodium foods including low-sodium or sodium-free dietary salts, 

gluten-free foods. 

Placing on the market: For 15 of the notified products it was stated that the products 
had already been on the market in another EU Member State before placement on the 
German  market.  Four  of  those  products  were  found  to  be  suitable  for  dietary 
purposes.  

2.1.10.  Greece 

A total of 15 notifications have been received and accepted by the Greek competent 
authority. An example of a notified product for particular nutritional uses is:  

– 

a  product  partially  covering  the  needs  of  certain  persons  that  present  peptic 
disturbances because of dietary excesses.  

Note:  Another  four  notifications  regarding  dietetic  food  for  partial  coverage  of  the 
nutritional needs of women during pregnancy and breastfeeding were not accepted, 
because there was no substantiation of the nutritional need.  

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"Food supplements" means foodstuffs the purpose of which is to supplement the normal diet and which 
are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone 
or in combination, marketed in dose form, namely forms  such as capsules, pastilles, tablets, pills and 
other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar 
forms  of  liquids  and  powders  designed  to  be  taken  in  measured  small  unit  quantities".  They  are 
regulated by Directive 2002/46/EC on food supplements. OJ L 183, 12.7.2002, p. 51–57. 
Foods  to  which  vitamins,  minerals  or  other  substances  have  been  added  are  regulated  by  Regulation 
(EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods. 
OJ L 404, 30.12.2006, p. 26–38. 

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2.1.11.  Hungary 

A  total  of  174  notifications  have  been  received  by  the  Hungarian  competent 
authority. The notified foods are all described as: 

– 

gluten-free foods (174).  

Note: Four of these products can be used by patients with phenylketonuria as well. 

2.1.12.  Ireland 

One product has been notified to the Irish competent authority. It is described as: 

– 

foods for people with lactose intolerance or lactase deficiency (1). 

Note:  The  specific  legislation  passed  into  law  in  Ireland  in  2002,  and  no  formal 
notification procedure was in place before that date. 

2.1.13.  Italy 

A total of 12000 notifications have been received by the Italian competent authority. 
Examples of notified foods for particular nutritional uses are:  

– 

– 

– 

– 

growth milk for infants,  

lactose-free milk,  

products for hydro-electrolytic regeneration in case of diarrhoea,  

food based on carbohydrates and group B vitamins to counteract ketose. 

Note: In the Italian legislation, notification is required also for food supplements and 
fortified foods. The Italian competent authority states that a significant proportion of 
the notifications is constituted by food supplements, but it was not possible to extract 
the number of dietetic foods from the total number of notifications. 

No information has been received for the period 2002-2005. 

2.1.14.  Latvia 

A total of four notifications have been received by the Latvian competent authority. 
The notified foods are described as: 

– 

dietetic  waters  suitable  for  different  purposes  (4).  For  example,  for  persons 
with an intensive amount of intellectual work, or for persons over 40, and who 
have a high radioactive environment and food pollution background. 

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2.1.15.  Lithuania 

No notification has been received by the Lithuanian competent authority. 

2.1.16.  Luxembourg 

No  notification  had  been  received  by  the  Luxembourg  competent  authority  until 
2001. No information has been received for the period 2002-2005. 

2.1.17.  Malta 

No notification has been received by the Maltese competent authority. 

2.1.18.  The Netherlands 

A  total  of  five  notifications  have  been  received  by  the  Dutch  competent  authority. 
The notified foods are described as: 

– 

foods low in sodium and marketed as suitable for low sodium diets (5). 

2.1.19.  Poland 

A total of 985 notifications have been received by the Polish competent authority. A 
substantial  part  of  those  (around  88%)  concerned  foodstuffs  intended  for  particular 
nutritional  uses  belonging  to  the  groups  of  foodstuffs  listed  in  Annex  1  of  the 
Directive.  

The remaining 119 notifications relate to food described as: 

– 

– 

– 

gluten-free foods (113), 

products with plant sterols (fat spreads and yoghurt drinks) (3), 

others: probiotics (2), growing up milk (1). 

2.1.20.  Portugal 

A total of 66 notifications have been received by the Portuguese competent authority. 
The notified foods have all been described as: 

– 

gluten-free foods (66). 

Note: The Portuguese authority reports on the notifications received from November 
2000, which is the date of the Decree-Law for transposition of Directive 1999/41/EC 
into national legislation. 

No information has been received for the period 2002-2005. 

Placing on the market: The marketing of these products had already been notified in 
other Member States before notification in Portugal. 

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2.1.21.  Slovak Republic 

No notification has been received by the Slovak Republic's competent authority.  

2.1.22.  Slovenia 

A total of 63 notifications have been received by the Slovenian competent authority. 
The notified foods are all described as: 

– 

gluten-free foods (63). 

Placing  on  the  market:  The  marketing  of  62  of  these  products  had  already  been 
notified in other EU Member States before notification was given to Slovenia. 

2.1.23.  Spain 

A total of 544 notifications have been received by the Spanish competent authority. 
A substantial part of those (around 50%) concerned foodstuffs intended for particular 
nutritional  uses  belonging  to  the  groups  of  foodstuffs  listed  in  Annex  1  of  the 
Directive, and therefore they are not included in this analysis. 

A total of 273 notifications have been accepted by the Spanish competent authority. 
The notified foods are described as:  

– 

– 

– 

gluten-free foods (215),  

low-sodium foods (56),  

foods for premature or low-birthweight babies (2). 

2.1.24.  Sweden 

A total of 1680 notifications have been received by the Swedish competent authority. 
The notified foods are described as: 

– 

– 

– 

– 

– 

– 

– 

gluten-reduced foods or naturally gluten-free foods (1128), 

foods reduced in or free from lactose, milk or milk protein (556),  

egg-free foods (160),  

soy-free foods (124),  

foods reduced in or free from protein/pea protein (89), 

phenylalanine-low foods (28), 

others:  foods  for  adults  with  an  extra  need  for  calcium,  such  as  women  after 
menopause  and  older  women  (6),  cholesterol-lowering  foods  and  foods  for 
extra  input  of  energy  or  proteins  (4),  foods  for  adults  with  an  extra  need  for 
iron (1) and other nutrients (2). 

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Note: The total of these notifications is higher than 1680 as each product can belong 
to  more  than  one  category  (for  example,  a  food  that  is  both  gluten-free  and  milk-
free). 

Placing on the market: Most products have not been notified in other Member States 
before placement on the Swedish market. 

2.1.25.  United Kingdom 

A total of 114 notifications have been received by the UK competent authority. The 
notified foods are described as: 

– 

– 

gluten-free foods (103),  

others:  breastmilk  fortifiers  (3),  growing  up  milk  (3)  and  foods  for  low-birth 
weight  infants  (2),  dietetic  salt  (1),  lactase  deficiency  management  foods  (1), 
weight management foods (1). 

Note: The specific legislation passed into UK law in 2002, and no formal notification 
procedure was in place before that date. 

Placing on the market: The UK does not have any information about whether these 
products have been notified for the first time in the UK, or if they have been notified 
previously in other Member States. 

3. 

DISCUSSION 

In  the  following  discussion  the  Commission  has  highlighted  the  main  issues  put 
forward  by  Member  States  regarding  the  implementation  of  Article  9,  grouping 
together relevant suggestions and examples from different Member States. 

1. 

2. 

Concerning  information  on  the  first-time  placing  of  a  product  on  the  market, 
several Member States expressed the view that it is often difficult to ascertain 
whether a food has been previously notified in another EU Member State. This 
can  be  due  to  the  fact  that  importers  often  do  not  specify  this  information. 
Moreover,  when  there  is  knowledge  that  the  food  has  been  placed  on  the 
market in the Community, the importer often does not know in which Member 
State. 

One Member State suggested simplifying the notification system and limiting it 
to  the  first  notification,  which  could  be  disseminated  electronically  between 
Member States. 

Some Member States commented that manufacturers or importers rarely notify 
modifications of the composition or of the labelling of dietetic foods that have 
been previously notified. Manufacturers and distributors sometimes change to a 
certain extent the composition, the claimed nutritional purpose, or the category 
of persons for whom the dietetic food is intended, so that a re-examination of 
compliance of the product with the legislation may become necessary.  

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3. 

4. 

One Member State underlined the fact that there is no obligation to inform the 
competent  authority  when  a  product  is  taken  off  the  market,  which  makes  it 
difficult  to  have  an  updated  overview  of  what  is  on  the  market.  Another 
Member  State  suggested  creating  the  obligation  for  notifiers  to  communicate 
any changes made to an already notified product.  

The  provisions  of  Article  9(3)  empower  Member  States,  where  necessary,  to 
require the manufacturer or the importer to produce the scientific work and the 
data establishing the product's compliance with Article 1(2). 

One  Member  State  suggested  exchanging  practices  and  specialist  knowledge 
among Member States on this issue. 

There  are  discrepancies  in  the  implementation  of  Article  9.  Several  Member 
States  have  received  notifications  for  foods  that  belong  to  one  of  the  groups 
listed in Annex I, which normally do not require notification under Article 9; 
even foods that are not covered by Directive 89/398/EEC have been notified. 
One  explanation  is  that  in  some  Member  States  notification  is  required  for  a 
wider  range  of  foods,  and  the  authorities  do  not  differentiate  between  the 
different types of notifications.  

On  the  other  hand,  an  analysis  of  the  notifications  shows  that  there  can  be  a 
number of reasons why it is difficult to apply the existing legislation. There are 
many so-called "borderline products", dietetic foods which may fall within the 
scope  of  different  pieces  of  legislation.  There  can  be  uncertainties  about 
dietetic foods being covered by a specific Directive or subject to the provisions 
of Article 9 as well as whether products are dietetic foods or normal foods. 

Article 9 vs. specific Directives 

Some Member States have taken the view that foods for people suffering from 
phenylketonuria  are  dietetic  foods  within  the  scope  of  Article  9,  while  others 
consider them as dietary foods for special medical purposes. The same kind of 
problem has occurred with "very low-energy products". 

Dietetic foods vs. foods for the general population 

Regarding  the  borderline  with  normal  foodstuffs,  the  most  frequent  cases  are 
summarised in the following examples:  

Some Member States consider foods with added plant sterols as dietetic foods, 
intended for people suffering from hypercholesterolemia, while other Member 
States consider these as foods for the general population.  

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A  similar  issue  arises  when  distinguishing  between  dietetic  foods  and  food 
supplements.  For  example,  some  Member  States  view  tablets  with  added 
vitamins  for  seniors  as  dietetic  food,  while  others  have  treated  them  as  food 
supplements. The Commission has noted that it is not possible for a food to be 
considered as both a dietetic food and a food supplement. In fact, according to 
the  definition  set  out  in  Article  2  (a)  of  Directive  2002/46/EC  on  the 
approximation  of  laws  of  Member  States  relating  to  foods  supplement,  the 
purpose of a food supplement is to supplement the normal diet. On the contrary 
dietetic  foods  are  foods  which  owing  to  their  special  composition  or 
manufacturing  process  are  suitable  for  a  specific  population  group.  As  a 
general  rule,  if  a  food  is  presented  in  a  dose  form,  as  referred  to  in  the 
definition of food supplements in Directive 2002/46/EC, it will be considered 
as  a  food  supplement;  but  if  a  case-by-case  examination  of  the  nutritional 
purpose of the food shows that it is intended for a certain category of persons 
who  are  in  a  special  physiological  condition  (and  not  for  the  general 
population), this product might be considered as a dietetic food. 

There  are  also  classification  concerns  regarding  fortified  foods  and  dietetic 
foods. In the report, for example, fortified cereals for children and adolescents 
have been notified as dietetic foods but, because of the recent entry into force 
of Regulation 1925/2006 on fortified foods (1 July 2007), such products could 
now be considered as fortified foods. 

Some categories of normal foods were considered as dietetic foods by certain 
Member States because of the use of claims such as "soy-free" or "milk-free". 
This  was  based  on  the  reasoning  that  these  foods  were  intended  specially  for 
persons with intolerances or allergies to specific ingredients. It should be noted 
that, in the case of "allergen labelling", the indications concerning the presence 
of  allergens  are  already  covered  by  Directive  2000/13/EC  on  general  food 
labelling10.  The  objective  of  that  legislation  is  to  provide  consumers  with 
comprehensive information on foodstuffs. To ensure that consumers suffering 
from  an  allergy  or  intolerance  have  information  on  the  ingredients  to  which 
they are sensitive, there is a requirement to indicate on the label a reference to 
the  name  of  the  allergenic  ingredients  identified  in  the  legislation.  It  is 
generally accepted that people who are sensitive to specific substances look at 
the list of ingredients for relevant information. In addition, foods which do not 
contain potentially allergenic ingredients cannot be automatically considered as 
dietetic foods.  

10 

Directive  2000/13/EC  of  20  March  2000  on  the  approximation  of  the  laws  of  the  Member  States 
relating to the labelling, presentation and advertising of foodstuffs. OJ L 109, 6.5.2000, p. 29–42, last 
amended  by  Commission  Directive  2007/68/EC  of  27  November  2007  amending  Annex  IIIa  to 
Directive  2000/13/EC  of  the  European  Parliament  and  of  the  Council  as  regards  certain  food 
ingredients. OJ L 310, 28.11.2007, p. 11-14. 

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It  should  be  noted  that  the  report  concerns  relevant  notifications  made  to 
Member  States  before  some  of  the  recent  food  legislation  was  in  place.  The 
evolution of EU legislation, such as the adoption of Directive 2002/46/EC on 
food  supplements,  is  already  having  an  effect  on  the  notification  system. 
Moreover, the recent entry into force of the Regulations on fortified foods and 
on nutrition and health claims is expected to have an impact on the category of 
foods notified under the Article 9 procedure. 

5. 

Looking  at  the  summary  table  that  presents  an  overview  of  the  notifications 
received  (see  Annex),  it  appears  that  a  good  percentage  of  the  total  of  3689 
notifications  (57%,  2107  notifications)  refers  to  gluten-free  products,  and  a 
second  significant  proportion  (21%,  764  notifications)  refers  to  lactose-free 
products.  It  can  thus  be  seen  that  there  are,  among  the  high  number  of 
notifications,  some  generally  accepted  categories  common  to  many  of  the 
Member States. 

4. 

CONCLUSION 

The provisions of Article 9 aim at facilitating the official monitoring of the products 
placed on the market. But, as a general comment, the majority of the Member States 
consider  that  the  notification  system  should  be  rationalised  to  ensure  more 
harmonised implementation of the provisions of this article across the EU.  

Categories  of  products  such  as  "gluten-free"  and  "lactose-free",  which  represent  a 
substantial proportion of the notifications, will be regulated through specific rules for 
the  use  of  such  terms  as  provided  for  in  Directive  89/398/EEC  on  dietetic  foods 
(Article 4a) and Regulation 1924/2006 on nutrition and health claims made on foods 
(recital  22).  Consequently,  only  the  remaining  products  for  which  specific  rules 
cannot  be  laid  down  because  they  are  innovative  products  or  because  they  are  not 
part of a generally recognised category of food will be covered by the provisions of 
Article 9. 

Inconsistencies  may  arise  from  different  interpretations  of  the  definition  of 
"foodstuffs  for  particular  nutritional  uses"  in  Article  1  of  Directive  89/398/EEC  on 
dietetic  foods,  which  has  different  elements  and  appears  to  be  open  to  different 
interpretations by the authorities.  

The provisions in Article 1 of Directive 89/398/EEC on dietetic foods indicate that, 
in addition to being aimed at certain categories of persons, dietetic foods have to be, 
owing to their special composition or manufacturing process, clearly distinguishable 
from foodstuffs for normal consumption. This report shows that this definition is not 
uniformly  interpreted  among  the  Member  States  and  therefore  agreement  on  the 
scope  of  application  needs  to  be  sought.  This  would  also  help  to  clarify  the 
differences in the scope of application between different pieces of legislation such as 
Directive  2002/46/EC  on  food  supplements  and  Regulation  1925/2006  on  the 
addition of vitamins and minerals and of certain other substances to foods (fortified 
foods).  

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In  the  light  of  these  considerations  it  becomes  clear  that  revision  of  Article  9, 
together with revision of other relevant articles, as appropriate, would be required for 
more effective and harmonised implementation of the dietetic food legislation. 

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