Proposal for a Directive of the European Parliament and of the Council on foodstuffs intended for particular nutritional uses (Recast)
Date: 2008-01-16
Institutions: European Commission
Subjects: baby food, consumer protection, dietary product, foodstuffs legislation, human nutrition, labelling, nutrition

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 16.01.2008 
COM(2008) 3 final 

2008/0003 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on foodstuffs intended for particular nutritional uses 

(Recast) 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

On  1  April  1987  the  Commission  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  codification  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  uses2  has  been  initiated  by  the  Commission  and  a  relevant 
proposal has been submitted to the legislative authority3. The new Directive was to 
have superseded the various acts incorporated in it4. 

In  the  meantime  Council  Decision  1999/468/EC  of  28  June  1999  laying  down  the 
procedures  for the exercise of implementing powers conferred on the Commission5 
has  been  amended  by  Decision  2006/512/EC,  which  introduced  a  regulatory 
procedure  with  scrutiny  for  measures  of  general  scope  designed  to  amend  non-
essential  elements  of  a  basic  instrument  adopted  in  accordance  with  the  procedure 
referred to in Article 251 of the Treaty, including by deleting some of those elements 
or by supplementing the instrument by the addition of new non-essential elements. 

In accordance with the joint statement of the European Parliament, the Council and 
the Commission6 on Decision 2006/512/EC, for this new procedure to be applicable 
to instruments adopted in accordance with the procedure laid down in Article 251 of 
the  Treaty  which  are  already  in  force,  those  instruments  must  be  adjusted  in 
accordance with the applicable procedures. 

It is therefore appropriate to transform the codification of Directive 89/398/EEC into 
a recast in order to incorporate the amendments necessary for the adjustment to the 
regulatory procedure with scrutiny. 

COM(87) 868 PV. 
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. 
COM(2004) 290 final. 
See Annex II, Part A of this proposal. 
OJ  L  184,  17.7.1999,  p.  23.  Decision  as  amended  by  Decision  2006/512/EC  (OJ  L  200,  22.7.2006, 
p. 11). 
OJ C 255, 21.10.2006, p. 1. 

1. 

2. 

3. 

4. 

5. 

1 
2 

3 
4 
5 

6 

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

2008/0003 (COD) 

Proposal for a 

DIRECTIVE …/…/EC OF THE EUROPEAN PARLIAMENT AND OF THE 
COUNCIL 

of […] 

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 Commission1, 

Having regard to the opinion of the European Economic and Social Committee2, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty3, 

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 uses4 has been 
substantially  amended  several  times5.  Since  further  amendments  are  to  be  made,  it 
should be recast in the interests of clarity. 

(cid:216) new 

1 
2 
3 
4 

5 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
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. 

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(2)  ⌦ Differences ⌫  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  functioning  of  the 
⌦ internal ⌫ market. 

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

(3) 

(4) 

(5) 

(6) 

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

The approximation of national laws ⌦ presupposes ⌫ 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 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. 

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

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(cid:208) 96/84/EC Recital 4 (adapted) 
and Recital 5 (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.  ⌦ However,  on  the  grounds  of 
consumer  health  protection,  marketing  authorisation  may  be  granted  only  after 
consultation of the European Food Safety Authority. ⌫ 

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

(9)  ⌦ 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  at  a  later  stage,  after  consultation  of  the  European 
Food Safety Authority ⌫. 

(10) 

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 

(11)  The  drawing-up  of  specific  Directives  implementing  the  basic  principles  of 
Community rules and amendments thereto are implementing  measures of a technical 
nature. Their adoption should be entrusted to the Commission in order to simplify and 
expedite the procedure. 

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

(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 Commission6. 

(cid:208) 

(13)  Power should be conferred on the Commission in particular to adopt certain specific 
Directives, a list of substances with specific nutritional purposes and other substances 

(cid:216) new 

6 

OJ  L  184,  17.7.1999,  p.  23.  Decision  as  amended  by  Decision  2006/512/EC  (OJ  L  200,  22.7.2006, 
p. 11). 

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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,  provisions  allowing  to  indicate  on  foodstuffs  for  normal 
consumption  that  they  are  suitable  for  a  particular  nutritional  use,  special  provisions 
for  foods  for  persons  suffering  from  carbohydrate  metabolism  disorders  (diabetes), 
rules  for  the  use  of  terms  concerning  the  reduction  or  absence  of  sodium  or  salt 
content or the absence of gluten, which may be used to describe the products, as well 
as  conditions  under  which  reference  may  be  made  in  labelling,  presentation  and 
advertising to a diet or to a category of persons. Since those measures are of general 
scope  and  are  designed  to  amend  non-essential  elements  of  this  Directive  or  to 
supplement this Directive by the addition of new non-essential elements, they should 
be adopted in accordance with the regulatory procedure with scrutiny provided for in 
Article 5a of Decision 1999/468/EC. 

(14)  When,  on  imperative  grounds  of  urgency,  the  normal  time-limits  for  the  regulatory 
procedure with scrutiny cannot be complied with, the Commission should be able to 
use the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for 
the adoption and amendment of a list  of substances with  specific nutritional purpose 
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, as well as for adoption of 
amendments  to  this  Directive  or  to  specific  Directives  when  it  is  established  that  a 
foodstuff  intended  for  particular  nutritional  uses  endangers  human  health  although  it 
complies with the relevant specific Directive. 

(15)  The  new  elements  introduced  into  this  Directive  only  concern  the  committee 
procedures. They therefore do not need to be transposed by the Member States. 

(16)  This  Directive  should  be  without  prejudice  to  the  obligations  of  the  Member  States 
relating  to  the  time-limits  for  transposition  into  national  law  and  application  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 

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

2.  Foodstuffs  for  particular  nutritional  uses  are  foodstuffs  which,  owing  to  their  special 
composition or manufacturing process, are clearly distinguishable from foodstuffs for normal 
consumption,  which  are  suitable  for  their  claimed  nutritional  purposes  and  which  are 
marketed in such a way as to indicate such suitability. 

⌦ 3. ⌫ A particular nutritional use must fulfil the particular nutritional requirements: 

⌦ (a) ⌫ 

of  certain  categories  of  persons  whose  digestive  processes  or  metabolism  are 

disturbed; or 

⌦ (b) ⌫ 

of  certain  categories  of  persons  who  are  in  a  special  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. 

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

Article 2 

(cid:208) 89/398/EEC 

2.  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) 
(cid:214) new 

However, in  accordance with provisions to be adopted (cid:214) by  the  Commission ,  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. 

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The  measures  referred  to  in  the  second  subparagraph,  designed  to  amend  non-essential 
elements  of  this  Directive  by  supplementing  it,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 15(3). 

(cid:216) new 

(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. 

2.  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) 
(cid:214) new 

Article 4 

1.  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) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

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

provisions regarding the quality of raw materials; 

hygiene requirements; 

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

a list of additives; 

provisions regarding labelling, presentation and advertising; 

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 ⌫, 

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– 

in  the  case  of  the  other  points,  (cid:214) by  the  Commission .  (cid:214) Those  measures, 
designed to amend non-essential elements of this Directive by supplementing it, shall 
be adopted in accordance with the regulatory procedure with scrutiny referred to in 
Article 15(3) 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. 

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

(cid:208) 89/398/EEC (adapted) 
(cid:214) new 

⌦ 3. ⌫  (cid:214) The  Commission  shall  adopt   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.  

(cid:214)Those  measures,  designed  to  amend  non-essential  elements  of  this  Directive  by 
supplementing  it,  shall  be  adopted   in  accordance  with  the  (cid:214) regulatory   procedure 
(cid:214) with scrutiny  ⌦ referred to ⌫ in Article ⌦ 15 ⌫ (cid:214) (3) . 

(cid:214) When  necessary,  those  measures  shall  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 15(4).  

(cid:208) 1999/41/EC Art. 1 pt. 1 
(adapted) 
(cid:214) new 

Article 5 

(cid:214) The  Commission  shall  adopt  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. 

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(cid:214)Those  measures,  designed  to  amend  non-essential  elements  of  this  Directive  by 
supplementing  it,  shall  be  adopted   in  accordance  with  the  (cid:214) regulatory   procedure 
(cid:214) with scrutiny  ⌦ referred to ⌫ in Article ⌦ 15 ⌫ (cid:214) (3) . 

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  

⌦ (a) ⌫ 

in  accordance  with  the  procedure  laid  down  in  Article  13  proceed  with  the 

preparation of the special provisions concerned, or 

⌦ (b) ⌫ 

present,  in  accordance  with  the  procedure  laid  down  in  Article 95  of  the 

Treaty, any appropriate proposals for amendments to this Directive. 

The  measures  referred  to  in  point  (a),  designed  to  amend  non-essential  elements  of  this 
Directive by supplementing it, shall be adopted in accordance with the regulatory procedure 
with scrutiny referred to in Article 15(3) of this Directive. 

(cid:216) new 

(cid:208) 89/398/EEC Art. 5 (adapted) 
(cid:214) new 

Article 7 

(cid:214) The  Commission  may  adopt   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. 

(cid:214)Those  measure,  designed  to  amend  non-essential  elements  of  this  Directive  by 
supplementing  it,  shall  be  adopted   in  accordance  with  the  (cid:214) regulatory   procedure 
(cid:214) with scrutiny  ⌦ referred to ⌫ in Article ⌦ 15 ⌫ (cid:214) (3) . 

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

Article 8 

1.  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. 

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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. 

2.  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 

1. ⌦ Directive 2000/13/EC of the European Parliament and of the Council ⌫7, ⌦ 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 ⌫. 

2. 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 ⌦ covered by ⌫ 
Article ⌦ 1(3)(c) ⌫, this reference shall be replaced by a reference to the purpose for which 
they are intended. 

3. 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 
its  particular  nutritional 
manufacturing  process  which  gives 
characteristics; 

the  product 

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) per 100 grams’ or by the words 
‘energy value less than 50 kilojoules (12 kilocalories) per 100 millilitres’. 

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

7 

⌦ OJ L 109, 6.5.2000, p. 29 ⌫. 

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

Article 10 

1.  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. 

2. 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)  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 ⌦ ; ⌫ 

⌦ (b)  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 ⌦ ; ⌫ 

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

⌦ 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. 

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

⌦ 3. ⌫ Detailed rules for implementing paragraph ⌦ 2 ⌫ may be adopted in accordance 
with the procedure ⌦ referred to ⌫ in Article ⌦ 15(2) ⌫. 

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⌦ 4. ⌫ ⌦ Every three years, and for the first time before 8 July 2002 ⌫, 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.  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. 

2.  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 

1. 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. 

2.  The  Commission  shall  examine  as  soon  as  possible  the  grounds  adduced  by  the  Member 
State  concerned,  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. 

3. 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) ⌫. 

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(cid:208) 89/398/EEC Art. 12 (adapted) 
(cid:214) new 

Article 14 

1.  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. 

2.  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. 

3. 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 ⌫.  

(cid:214) Those  measures,  designed  to  amend  non-essential  elements  of  this  Directive,  shall  be 
adopted   ⌦ in  accordance  with ⌫  the  (cid:214) regulatory   procedure  (cid:214) with  scrutiny  
⌦ referred to ⌫ in Article ⌦ 15 ⌫ (cid:214) (4) .  

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) 
(cid:214) new 

Article 15 

1.  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 ⌫8, hereinafter referred to as “the Committee”. 

2.  Where 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

this  ⌦ paragraph ⌫,  Articles  5  and  7  of 

is  made 

reference 

to 

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

8 

OJ L 31, 1.2.2002, p. 1. 

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(cid:214) 3.  Where  reference  is  made  to  this  paragraph,  Article  5a(1)  to  (4),  and  Article  7  of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.  

(cid:214) 4. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 
of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.  

3. 

The Committee shall adopt its rules of procedure. 

(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 and application 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 
[…] 

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(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 Directives: 

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 Directive, dependent on the outcome of the 
procedure described in Article ⌦ 6 ⌫: 

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

____________ 

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(cid:207) 

ANNEX II 

Part A 

Repealed Directive with list of 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 

point 15 of Annex III only 

List of time limits for transposition into national law and application 
(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. 

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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(1)(a) 

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(3) 

Article 11(4) 

Article 12 

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Article 11 

Article 12 

Article 13 

Article 14 

Article 13(1) and (2) 

Article 15(1) and (2) 

Article 13(3) 

– 

– 

Article 15(3) and (4) 

Articles 14 and 15 

– 

– 

Article 16 

Annex I 

Annex II 

– 

Articles 16 and 17 

Article 18 

Annex I 

– 

Annexes II and III 

____________ 

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