Proposal for a Directive of the European Parliament and of the Council on foodstuffs intended for particular nutritional uses (Codified version)
Date: 2004-04-22
Institutions: European Commission
Subjects: approximation of laws, foodstuff, health policy, labelling

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 22.4.2004 
COM(2004) 290 final 

2004/0090 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on foodstuffs intended for particular nutritional uses 

(Codified version) 

(presented by the Commission) 

EN 

   EN 

 
 
 
  
 
 
1. 

2. 

3. 

4. 

EXPLANATORY MEMORANDUM 

In  the  context  of  a  people’s  Europe,  the  Commission  attaches  great  importance  to 
simplifying  and  clarifying  Community  law  so  as  to  make  it  clearer  and  more 
accessible to the ordinary citizen, thus giving them new opportunities and the chance 
to make use of the specific rights it gives him. 

This aim cannot be achieved so long as numerous provisions that have been amended 
several times, often quite substantially, remain scattered, so that they must be sought 
partly  in  the  original  instrument  and  partly  in  later  amending  ones.  Considerable 
research work, comparing many different instruments, is thus needed to identify the 
current rules. 

For  this  reason  a  codification  of  rules  that  have  frequently  been  amended  is  also 
essential if Community law is to be clear and transparent. 

On  1  April  1987  the  Commission  therefore  decided1  to  instruct  its  staff  that  all 
legislative measures should be codified after no more than ten amendments, stressing 
that  this  was  a  minimum  requirement  and  that  departments  should  endeavour  to 
codify at even shorter intervals the texts for which they are responsible, to ensure that 
the Community rules were clear and readily understandable. 

The  Conclusions  of 
the  Edinburgh  European  Council 
(December 1992) confirmed this2, stressing the importance of codification as it offers 
certainty as to the law applicable to a given matter at a given time. 

the  Presidency  of 

Codification  must  be  undertaken  in  full  compliance  with  the  normal  Community 
legislative procedure. 

Given  that  no  changes  of  substance  may  be  made  to  the  instruments  affected  by 
codification, the European Parliament, the Council and the Commission have agreed, 
by  an  interinstitutional  agreement  dated  20  December  1994,  that  an  accelerated 
procedure may be used for the fast track adoption of codification instruments. 

is 

this  proposal 

to  undertake  a  codification  Council 
The  purpose  of 
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  uses3.  The 
new Directive will supersede the various acts incorporated in it4; this proposal fully 
preserves the content of the acts being codified and hence does no more than bring 
them together with only such formal amendments as are required by the codification 
exercise itself. 

1 
2 
3 

4 

COM(87) 868 PV. 
See Annex 3 to Part A of such Conclusions.  
Carried out pursuant to the Communication from the Commission to the European Parliament and the 
Council – Codification of the Acquis communautaire, COM(2001) 645 final. 
See Annex II, Part A of this proposal. 

2 

 
 
  
 
                                                 
5. 

The codification proposal was drawn up on the basis of a preliminary consolidation, 
in all official languages, of Directive 89/398/EEC and the instruments amending it, 
carried out by the Office for Official Publications of the European Communities, by 
means  of  a  data-processing  system.  Where  the  Articles  have  been  given  new 
numbers,  the  correlation  between  the  old and  the  new  numbers  is  shown  in  a  table 
contained in Annex III to the codified Directive. 

3 

 
 
  
 
(cid:208) 89/398/EEC (adapted) 

2004/0090 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on foodstuffs intended for particular nutritional uses 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article ⌦ 95 ⌫ thereof, 

Having regard to the proposal from the Commission, 

Having regard to the opinion of the European Economic and Social Committee1, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty2, 

Whereas: 

(1) 

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 uses3 has been 
substantially amended several times4. In the interests of clarity and rationality the said 
Directive should be codified. 

(cid:208)  

(2)  ⌦ D ⌫ifferences  between  national  laws  relating  to  foodstuffs  for  particular 
nutritional  uses  impede  their  free  movement,  may  create  unequal  conditions  of 
competition,  and  thus  ⌦ have ⌫  a  direct  impact  on  the  establishment  and 
functioning of the common market. 

(cid:208) 89/398/EEC Recital 2 (adapted) 

1 
2 
3 

4 

OJ C 
OJ C 
OJ  L  186,  30.6.1989,  p.  27.  Directive  as  last  amended  by  Regulation  (EC)  No  1882/2003  of  the 
European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 
See Annex II, Part A. 

4 

 
 
  
 
 
 
 
                                                 
(3) 

The approximation of national laws presuppose ⌦ s ⌫ the drawing-up of a common 
definition,  the  determination  of  measures  enabling  the  consumer  to  be  protected 
against fraud concerning the nature of these products and the adoption of rules to be 
complied with in labelling the products in question. 

(cid:208) 89/398/EEC Recital 3 (adapted) 

(cid:208) 89/398/EEC Recital 4 

(4) 

The products covered by this Directive are foodstuffs, the composition and preparation 
of which must be specially designed to meet the particular nutritional requirements of 
the  persons  for  whom  they  are  mainly  intended.  It  may  be  necessary,  therefore,  to 
provide for derogations from the general or specific provisions applicable to foodstuffs 
in order to achieve the specific nutritional objective. 

(5) 

Although  foodstuffs  intended  for  particular  nutritional  uses  which  are  the  subject  of 
specific  provisions  can  be  efficiently  monitored  on  the  basis  of  the  general  rules  for 
monitoring  all  types of foodstuffs, this  is not  always the  case  for those foodstuffs in 
respect of which no such specific provisions exist. 

(cid:208) 89/398/EEC Recital 5 

(cid:208) 89/398/EEC Recital 6 

(6) 

For the latter the usual means available to the monitoring bodies might not in certain 
cases enable them to check whether a foodstuff actually has the particular nutritional 
properties attributed to it. It is necessary therefore to provide that, where necessary, the 
person  responsible  for  placing  that  foodstuff  on  the  market  should  assist  the 
monitoring body in carrying out its activities. 

(7)  ⌦ Specific provisions applicable to certain groups of foodstuffs should be laid down 

by means of specific Directives. ⌫  

(cid:208) 89/398/EEC Recital 8 (adapted) 

(8) 

A  procedure ⌦ should ⌫  be  laid  down  which  allows  the  foodstuffs  resulting  from 
technological innovations to be placed on the market on a temporary basis in order that 
proper  benefit  may  be  derived  from  the  fruits  of  industry  research  pending  the 
amendment of the specific Directive concerned. 

(cid:208) 96/84/EC Recital 4 (adapted) 

5 

 
 
  
 
 
 
 
 
 
 
(9) 

However, on the grounds of consumer health protection, marketing authorisation may 
be granted only after consultation of the ⌦ European Food Safety Authority ⌫ . 

(cid:208) 96/84/EC Recital 5 (adapted) 

(cid:208) 1999/41/EC Recital 5 (adapted) 

(10)  ⌦ Since it ⌫ is not clear whether an adequate basis exists for specific provisions to 
be  adopted  for  the  group  of  foods  intended  for  persons  suffering  from  carbohydrate 
metabolism  disorders  (diabetes) ⌦ ,  the  Commission  should  be  allowed  to  adopt  or 
propose  the  relevant  provisions  in  a  later  stage,  after  consultation  of  the  European 
Food Safety Authority ⌫ . 

(11) 

It is still possible to harmonise, at Community level, rules applicable to other groups 
of foodstuffs for particular nutritional uses, in the interests of consumer protection and 
the free movement of such foodstuffs. 

(cid:208) 1999/41/EC Recital 7 

(cid:208)  

(12)  The measures necessary for the implementation of this Directive should be adopted in 
accordance  with  Council  Decision  1999/468/EC  of  28  June  1999  laying  down  the 
procedures for the exercise of implementing powers conferred on the Commission5. 

(13)  This  Directive  should  be  without  prejudice  to  the  obligations  of  the  Member  States 
relating to the time-limits for transposition into national law of the Directives set out in 
Annex II, Part B, 

HAVE ADOPTED THIS DIRECTIVE: 

(cid:208) 89/398/EEC 

1. 

This Directive concerns foodstuffs for particular nutritional uses. 

Article 1 

2. 

Foodstuffs for particular nutritional uses are foodstuffs which, owing to their special 
composition  or  manufacturing  process,  are  clearly  distinguishable  from  foodstuffs 

(cid:208) 89/398/EEC (adapted) 

5 

OJ L 184, 17.7.1999, p. 23. 

6 

 
 
  
 
 
 
 
 
 
 
                                                 
for  normal  consumption,  which  are  suitable  for  their  claimed  nutritional  purposes 
and which are marketed in such a way as to indicate such suitability. 

⌦ 3. ⌫ 

A particular nutritional use must fulfil the particular nutritional requirements: 

1. 

2. 

⌦ (a) ⌫ 

of  certain  categories  of  persons  whose  digestive  processes  or 

metabolism are disturbed; or 

⌦ (b) ⌫ 

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

⌦ (c) ⌫ 

of infants or young children in good health. 

Article 2 

The  products  referred  to  in  Article  ⌦ 1(3)(a)  and  (b) ⌫  may  be  characterised  as 
‘dietetic’ or ‘dietary’. 

(cid:208) 89/398/EEC 

In  the  labelling,  presentation  and  advertising  of  foodstuffs  for  normal  consumption 
the following shall be prohibited: 

(a) 

(b) 

the  use  of  the  adjectives  ‘dietetic’  or  ‘dietary’  either  alone  or  in  conjunction 
with other words, to designate these foodstuffs; 

all other markings or any presentation likely to give the impression that one of 
the products referred to in Article 1 is involved. 

(cid:208) 89/398/EEC (adapted) 

However,  in  accordance  with  provisions  to  be  adopted  according  to  the  procedure 
⌦ referred  to ⌫  in  Article  ⌦ 15(2)⌫  ,  it  shall  be  possible  for  foodstuffs  for 
normal  consumption  which  are  suitable  for  a  particular  nutritional  use  to  indicate 
such suitability. 

⌦ Such ⌫  provisions  may  lay  down  the  arrangements  for  indicating  this 
suitability. 

(cid:208) 89/398/EEC 

Article 3 

1. 

The nature or composition of the products referred to in Article 1 must be such that 
the products are appropriate for the particular nutritional use intended. 

7 

 
 
  
 
 
 
 
2. 

1. 

The  products  referred  to  in  Article  1  must  also  comply  with  any  mandatory 
provisions applicable to foodstuffs for normal consumption, save as regards changes 
made to them to ensure their conformity with the definitions given in Article 1. 

(cid:208) 89/398/EEC (adapted) 

Article 4 

The  specific  provisions  applicable  to  the  groups  of ⌦ foodstuffs ⌫  for  particular 
nutritional  uses  appearing  in  Annex  I  shall  be  laid  down  by  means  of  specific 
Directives. 

Such specific Directives may cover in particular: 

(a) 

essential requirements as to the nature or composition of the products; 

(b)  provisions regarding the quality of raw materials; 

(c) 

hygiene requirements; 

(d)  permitted changes within the meaning of Article 3(2); 

(e) 

a list of additives; 

(f) 

provisions regarding labelling, presentation and advertising; 

(g) 

sampling  procedures  and  methods  of  analysis  necessary  for  checking 
compliance with the requirements of the specific Directives. 

Such specific Directives shall be adopted: 

– 

– 

in  the  case  of  point  (e),  in  accordance  with  the  procedure  laid  down  in 
Article ⌦ 95 of the Treaty ⌫ , 

in  the  case  of  the  other  points,  in  accordance  with  the  procedure ⌦ referred 
to ⌫ in Article ⌦ 15(2) of this Directive ⌫ . 

Provisions  likely  to  have  an  effect  on  public  health  shall  be  adopted  after 
consultation of the ⌦ European Food Safety Authority. ⌫ 

(cid:208) 96/84/EC Art. 1 (adapted) 

⌦ 2. ⌫ 

To enable foodstuffs intended for particular nutritional uses and resulting from 
scientific  and  technological  progress  to  be  placed  on  the  market  rapidly,  the 
Commission  may,  after  consulting  the ⌦ European  Food  Safety  Authority ⌫  and 
in accordance with the procedure ⌦ referred to ⌫ in Article ⌦ 15(2)⌫, authorise 
for a two-year period the placing on the market of foodstuffs which do not comply 
with the rules as to composition laid down by the specific directives ⌦ for groups of 
foodstuffs for particular nutritional uses ⌫ referred to in Annex I. 

8 

 
 
  
 
 
 
If  necessary,  the  Commission  may  add  in  the  authorisation  decision  labelling  rules 
relating to the change in composition.  

(cid:208) 89/398/EEC (adapted) 

⌦ 3. ⌫ 

A  list  of  substances  with  specific  nutritional  purposes  such  as  vitamins, 
mineral  salts,  amino  acids  and  other  substances  intended  to  be  added  to  foodstuffs 
intended for particular nutritional uses, together with the purity criteria applicable to 
them, and, where appropriate, the conditions under which they should be used, shall 
be  adopted 
in 
Article ⌦ 15(2) ⌫. 

the  procedure  ⌦ referred 

in  accordance  with 

to ⌫ 

(cid:208) 1999/41/EC Art. 1 pt. 1 
(adapted) 

Article 5 

Rules  for  the  use  of  terms  concerning  the  reduction  or  absence  of  sodium  or  salt  (sodium 
chloride, table salt) content ⌦ or ⌫ the absence of gluten, which may be used to describe 
the  products  referred  to  in  Article  1,  shall  be  adopted  in  accordance  with  the  procedure 
⌦ referred to ⌫ in Article ⌦ 15(2) ⌫ . 

Article 6 

Before  8  July  2002,  the  Commission  shall,  after  consulting  the  ⌦ European  Food  Safety 
Authority  ⌫  ,  present  to  the  European  Parliament  and  to  the  Council  a  report  on  the 
desirability  of  special  provisions  for  foods  for  persons  suffering  from  carbohydrate 
metabolism disorders (diabetes). 

In the light of the conclusions of this report, the Commission shall either, in accordance with 
the procedure ⌦ referred to ⌫ in Article ⌦ 15(2) ⌫ , proceed with the preparation of the 
special provisions concerned or shall present, in accordance with the procedure laid down in 
Article 95 of the Treaty, any appropriate proposals for amendments to this Directive. 

(cid:208) 89/398/EEC Art. 5 (adapted) 

Article 7 

Conditions under which reference may be made in labelling, presentation and advertising to a 
diet or to a category of persons for which a product referred to in Article 1 is intended may be 
adopted in accordance with the procedure ⌦ referred to ⌫ in Article ⌦ 15(2) ⌫ . 

9 

 
 
  
 
 
 
 
1. 

2. 

1. 

2. 

3. 

(cid:208) 89/398/EEC Art. 6 (adapted) 

Article 8 

The labelling and the labelling methods used, the presentation and the advertising of 
the  products  referred  to  in  Article  1  ⌦ shall ⌫  not  attribute  properties  for  the 
prevention,  treatment  or  cure  of  human  disease  to  such  products  or  imply  such 
properties. 

Derogations from the first subparagraph may be provided for in accordance with the 
procedure  ⌦ referred  to ⌫  in  Article  ⌦ 15(2) ⌫  in  exceptional  and  clearly 
defined  cases.  Derogations  may  be  continued  until  that  procedure  has  been 
completed. 

Paragraph  1  shall  not  prevent  the  dissemination  of  any  useful  information  or 
recommendations exclusively intended for persons having qualifications in medicine, 
nutrition or pharmacy. 

(cid:208) 89/398/EEC Art. 7 (adapted) 

Article 9 

⌦ Directive 2000/13/EC of the European Parliament and of the Council ⌫6 , shall 
apply  to  the  products  referred  to  in  Article  1  ⌦ of  this  Directive ⌫  ,  under  the 
conditions set out ⌦ in paragraphs 2, 3 and 4 of this Article ⌫ . 

The designation under which a product is sold shall be accompanied by an indication 
of  its  particular  nutritional  characteristics.  However,  in  the  case  of  the  products 
referred to in Article ⌦ 1(3)(c) ⌫ , this reference shall be replaced by a reference 
to the purpose for which they are intended. 

The  labelling  of  products  for  which  no  specific  Directive  has  been  adopted  in 
accordance with Article 4 shall also include: 

(a) 

(b) 

the  particular  elements  of  the  qualitative  and  quantitative  composition  or  the 
special manufacturing process which gives the product its particular nutritional 
characteristics; 

the  available  energy  value  expressed  in  kilojoules  and  kilocalories  and  the 
carbohydrate,  protein  and  fat  content  per  100  grams  or  100  millilitres  of  the 
product  as  marketed  and,  where  appropriate,  per  specified  quantity  of  the 
product as proposed for consumption. 

If,  however,  the  energy  value  is  less  than  50  kilojoules  (12  kilocalories)  per 
100 grams  or  100  millilitres  of  the  product  as  marketed,  these  particulars  may  be 
replaced either by the words ‘energy value less than 50 kilojoules  (12 kilocalories) 

6 

⌦ OJ L 109, 6.5.2000, p. 29 ⌫. 

10 

 
 
  
 
 
 
                                                 
per  100 grams’  or  by 
(12 kilocalories) per 100 millilitres’. 

the  words  ‘energy  value 

less 

than  50  kilojoules 

4. 

The  particular  labelling  requirements  for  those  products  for  which  a  specific 
Directive has been adopted shall be laid down in that Directive. 

(cid:208) 89/398/EEC Art. 8 (adapted) 

Article 10 

1. 

2. 

The  products  referred  to  in  Article  1  shall  only  be  allowed  on  the  retail  market  in 
pre-packaged form, and the packaging shall completely cover the products. 

Member States may permit derogations from ⌦ paragraph 1 ⌫ for purposes of the 
retail trade provided that the product is accompanied by the particulars provided for 
in Article ⌦ 9 ⌫ at the time when it is put on sale. 

(cid:208) 89/398/EEC Art. 9 (adapted) 

Article 11 

⌦ 1. ⌫ 

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: 

⌦ (a)⌫  ⌦ w ⌫hen  a  product  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 ⌦ ; ⌫ 

⌦ (b) ⌫  ⌦ w ⌫here 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 ⌦ ; ⌫ 

⌦ (c) ⌫  ⌦ w ⌫here  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) 
in 
Article ⌦ 9 ⌫(3)(a).  If  such  work  is  contained  in  a  readily  available 
publication, a mere reference to this publication shall suffice. 

together  with 

information 

provided 

the 

for 

⌦ 2. ⌫ Member States shall communicate to the Commission the identity of the competent 
authorities  within  the  meaning  of  ⌦ paragraph  1 ⌫  and  any  other  useful 
information on them. 

11 

 
 
  
 
 
 
The  Commission  shall  publish  this  information  in  the  Official  Journal  of  the 
European ⌦ Union ⌫ . 

⌦ 3. ⌫ 

Detailed rules for implementing paragraphs ⌦ 1 and 2 ⌫ may be adopted in 

accordance with the procedure ⌦ referred to ⌫ in Article ⌦ 15(2) ⌫. 

⌦ 4. ⌫ 

Before  8  July  ⌦ 2005 ⌫  and  every  three  years  thereafter,  the  Commission 
shall send the European Parliament and the Council a report on the implementation 
of this Article. 

(cid:208) 1999/41/EC Art. 1 pt. 2 
(adapted) 

(cid:208) 89/398/EEC Art. 10 

Article 12 

1. 

2. 

1. 

2. 

3. 

Member  States  shall  not,  for  reasons  related  to  their  composition,  manufacturing 
specifications, presentation or labelling, prohibit or restrict trade in products referred 
to  in  Article  1  which  comply  with  this  Directive  and  where  appropriate,  with 
Directives adopted in implementation of this Directive. 

Paragraph 1 shall not affect national provisions which are applicable in the absence 
of Directives adopted in implementation of this Directive. 

(cid:208) 89/398/EEC Art. 11 (adapted) 

Article 13 

Where a Member State has detailed grounds for establishing that a foodstuff intended 
for a particular nutritional use which does not belong to one of the groups listed in 
Annex  I  does  not  comply  with  Article  1(2)  ⌦ and  (3) ⌫  or  endangers  human 
health,  albeit  freely  circulating  in  one  or  more  Member  States,  that  Member  State 
may temporarily suspend or restrict trade in that product within its territory. It shall 
immediately inform the Commission and the other Member States thereof and give 
reasons for its decision. 

The  Commission  shall  examine  as  soon  as  possible  the  grounds  adduced  by  the 
Member  State  concerned,  consult  the  Member  States  within  the  Committee 
⌦ referred to in Article 15(1) ⌫ , and shall then deliver its opinion without delay 
and take appropriate measures. 

If  the  Commission  considers  that  the  national  measure  must  be  dispensed  with  or 
modified,  it  shall  ⌦ adopt  the  appropriate  measures  in  accordance  with ⌫  the 
procedure ⌦ referred to ⌫ in Article ⌦ 15(2) ⌫ . 

12 

 
 
  
 
 
 
 
1. 

2. 

3. 

1. 

2. 

(cid:208) 89/398/EEC Art. 12 (adapted) 

Article 14 

Where  a  Member  State,  as  a  result  of  new  information  or  of  a  reassessment  of 
existing  information  made  since  one  of  the  specific  Directives  was  adopted,  has 
detailed  grounds  for  establishing  that  a  foodstuff  intended  for  particular  nutritional 
uses  endangers  human  health  although  it  complies  with  the  relevant  specific 
Directive, that Member State may temporarily suspend or restrict application of the 
provisions  in  question  within  its  territory.  It  shall  immediately  inform  the  other 
Member States and the Commission thereof and give reasons for its decision. 

The  Commission  shall  examine  as  soon  as  possible  the  grounds  adduced  by  the 
Member State concerned and shall consult the Member States within the Committee 
⌦ referred to in Article 15(1) ⌫ , and shall then deliver its opinion without delay 
and take appropriate measures. 

If  the  Commission  considers  that  amendments  to  this  Directive  or  to  the  specific 
Directives are necessary in order to remedy the difficulties mentioned in paragraph 1 
and to ensure the protection of human health, it shall ⌦ adopt those amendments in 
accordance  with ⌫  the  procedure  ⌦ referred  to ⌫  in  Article  ⌦ 15(2) ⌫  .  The 
Member State which has adopted safeguard measures may in that event retain them 
until the amendments have been adopted. 

(cid:208) 1882/2003 Art. 3 and 
Annex III, pt. 15 (adapted) 

Article 15 

The Commission shall be assisted by the Standing Committee on the Food Chain and 
Animal  Health,  set  up  by  Article  58  of  Regulation  (EC)  No  178/2002  ⌦ of  the 
European  Parliament  and  of  the  Council ⌫  7,  hereinafter  referred  to  as  “the 
Committee”. 

Where  reference  is  made  to  this  ⌦ paragraph ⌫ 
,  Articles  5  and  7  of 
Decision 1999/468/EC  shall  apply,  having  regard  to  the  provisions  of  Article  8 
thereof. 

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three 
months. 

3. 

The Committee shall adopt its rules of procedure. 

7 

OJ L 31, 1.2.2002, p. 1. 

13 

 
 
  
 
 
 
                                                 
(cid:208)  

Article 16 

Directive 89/398/EEC, as amended by the acts listed in Annex II, Part A, is repealed, without 
prejudice to the obligations of the Member States relating to the time-limits for transposition 
into national law of the Directives set out in Annex II, Part B. 

References  to  the  repealed  Directive  shall  be  construed  as  references  to  this  Directive  and 
shall be read in accordance with the correlation table in Annex III. 

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

Article 17 

(cid:208) 89/398/EEC Art. 16 

Article 18 

This Directive is addressed to the Member States. 

Done at Brussels, […] 

For the European Parliament 
The President 
[…] 

For the Council 
The President 
[…] 

14 

 
 
  
 
 
 
(cid:208) 1999/41/EC Art. 1 pt. 3 
(adapted) 

ANNEX I 

⌦ A. ⌫ 

Groups  of  foodstuffs  for  particular  nutritional  uses  for  which  specific 

provisions will be laid down by specific Directives1: 

1. 

2. 

3. 

4. 

5. 

infant formulae and follow-on formulae 

processed, cereal-based foods and baby foods for infants and young children 

food intended for use in energy-restricted diets for weight reduction 

dietary foods for special medical purposes 

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

⌦ B. ⌫ 

Groups  of  foodstuffs  for  particular  nutritional  uses  for  which  specific 
provisions will be laid down by a specific Directive2, dependent on the outcome of 
the procedure described in Article ⌦ 6 ⌫ : 

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

____________ 

1 
2 

It is understood that products already on the market when Directive is adopted will not be affected by it. 
It is understood that products already on the market when Directive is adopted will not be affected by it. 

15 

 
 
  
 
 
                                                 
(cid:207) 

ANNEX II 

Part A 

Repealed Directive with its successive amendments 
(referred to in Article 16)  

Council Directive 89/398/EEC 

(OJ L 186, 30.6.1989, p. 27) 

Directive 96/84/EC of the European Parliament and of 
the Council 

(OJ L 48, 19.2.1997, p. 20) 

Directive 1999/41/EC of the European Parliament and 
of the Council 

(OJ L 172, 8.7.1999, p. 38) 

Regulation (EC) No 1882/2003 of the European 
Parliament and of the Council 

(OJ L 284, 31.10.2003, p. 1) 

Part B 

List of time limits for transposition into national law 
(referred to in Article 16) 

Directive 

Time-limits for 
transposition 

Permission of trade 
in products 
complying with this 
Directive 

Prohibition of trade 
in products not 
complying with this 
Directive 

89/398/EEC 

16 May 1990 

16 May 19911 

96/84/EC 

30 September 1997 

1999/41/EC 

8 July 1999 

8 July 2000 

8 January 2001 

____________ 

1 

In accordance with Article 15 of Directive 89/398/EEC: 
“1. Member states shall amend their laws, regulations and administrative provisions in such way as: 
- 
- 
They shall forthwith inform the Commission thereof. 
2. Paragraph 1 shall not affect those national provisions which in the absence of the Directives referred 
to in Article 4 apply to certain groups of foodstuffs intended for particular nutritional uses.” 

to permit trade in products complying with this Directive not later than 16 May 1990, 
to prohibit trade in products not complying with this Directive with effect from 16 May 1991. 

16 

 
 
  
 
 
 
 
 
                                                 
 
 
 
 
 
ANNEX III 

CORRELATION TABLE 

Directive 89/398/EEC 

This Directive 

Article 1(1) 

Article 1(2)(a) 

Article 1(2)(b) 

Article 1(1) 

Article 1(2) 

Article 1(3) 

Article 1(2)(b)(i), (ii) and (iii) 

Article 1(3)(a), (b) and (c) 

Article 2(1) 

Article 2(2) 

Article 2(3) 

Article 3 

Article 4(1) 

Article 4(1a) 

Article 4(2) 

Article 4a 

Article 4b 

Article 5 

Article 6 

Article 7 

Article 8 

Article 2(1) 

Article 2(2) first subparagraph 

Article 2(2) second and third subparagraphs 

Article 3 

Article 4(1) 

Article 4(2) 

Article 4(3) 

Article 5 

Article 6 

Article 7 

Article 8 

Article 9 

Article 10 

Article 9 introductory words 

Article 11(1) introductory words 

Article 9 points 1, 2 and 3 

Article 11(1)(a), (b) and (c) 

Article 9 point 4, first and second sentence 

Article 11(2) 

Article 9 point 4, third sentence 

Article 9 point 5 

Article 10 

Article 11 

Article 11(3) 

Article 11(4) 

Article 12 

Article 13 

17 

 
 
  
 
Article 12 

Article 13 

Articles 14 and 15 

– 

Article 16 

Annex I 

Annex II 

– 

Article 14 

Article 15 

– 

Articles 16 and 17 

Article 18 

Annex I 

– 

Annexes II and III 

____________ 

18