Amended proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE amending Directive 89/398/EEC on the approximation of the laws of Member States relating to foodstuffs intended for particular nutritional uses
Date: 1995-11-29
Institutions: European Commission
Subjects: approximation of laws, baby food, cereal product, dietary product, processed food product

COMMISSION  OF THE EUROPEAN  COMMUNITIES 

Brussels,  29.11.1995 
COM(95)  588  final 

94/0076 (COD) 

Amended  proposal  for  a 

EUROPEAN  PARLIAMENT  AND  COUNCIL  DIRECTIVE 

amending Directive 89/398/EEC on the approximation of the laws of Member States relating to 

foodstuffs  intended for particular nutritional uses 

(presented  by  the  Commission  pursuant  to  Article  189  a (2) 
of  the  EC-Treaty) 

Explanatory memorandum 

In  response  to  the  opinion  of  the  European  Parliament1  delivered  on  11 October  1995  on  the 
proposal  for  a European  Parliament  and  Council  Directive  amending  Directive  89/398/EEC  on 
the  approximation  of  the  laws  of  Member  States  relating  to  foodstuffs  intended  for  particular 
nutritional uses2 which aimed to modify  the list of groups of foods for particular nutritional uses 
for  which  specific  directives  shall  be  adopted,  and  in  accordance  with  article  189A of  the  EC 
Treaty, the Commission has decided to amend the above mentioned proposal. 

The Commission has accepted the amendments relating to : 

- 

- 

the introduction of a new recital referring  to the agreement on a "modus vivendi" between the 
European Parliament, the Council and the Commission (amendment 1). 

the  inclusion  of  foods  for  persons  suffering  from  carbohydrate  metabolism  disorders 
(diabetes)  in the groups of foods  listed  in Annex I for  which  specific  provisions  will  be laid 
down by specific directives (amendment  18 in part, amendment  16 in part). 

-  defining  the conditions for the use of the terms low-sodium, reduced-sodium  and  sodium-free 
and  gluten-free  for  dietetic  foods  where  the  scientific  basis  for  doing  so  is  available  (the 
principle of amendment  17). 

-  recalling  in the recitals that  it remains possible to harmonise  other  rules  for  other  groups of 

foods for particular nutritional uses (amendment 4) 

The Commission did not accept the amendments concerning : 

- 

- 

- 

the  inclusion  of  low-sodium  foods  and  gluten-free  foods  in  the  groups  of  foods  listed  in 
Annex I for  which  specific  directives  shall  be adopted  (amendments  18 in part,  amendment 
without number on a separate vote, amendment  16 in part).  The Commission  maintains that 
such  specific  directives  are  not  necessary  for  the  reasons  it  has  explained  in  its  original 
proposal and because in addition now it has accepted to define the conditions under which the 
terms relating to sodium and gluten content can be used. 

the  pesticide  levels  and  residues  in  infant  formulae  and  baby  foods  because  this  is  not  the 
appropriate directive for such references to be made (amendments 9 and, 10 and 16). 

the  addition  of  a new paragraph  in  article  4  stating  that  new  groups  of  foods  for  particular 
nutritional uses may be added in Annex I (amendment 5).  This is the case now and would be 
superfluous to have it in the articles.  An amendment (n° 4) for a recital on this point has been 
accepted. 

1 O.J 

2 O.J. N° C108  16.04.1994, p. 17 

I 

creation  of  a  new  Annex  la  comprising  allowed  claims  for  dietetic  foods  (amendment  6). 
There  are  no  suggestion  for  any  specific  claims  to  appear  in  that  Annex,  therefore  the 
Commission considers it unnecessary. 

3 

In  response  to  the  opinion  of  the  European  Parliament3  delivered  on  11 October  1995  on  the 
proposal  for  a European  Parliament  and  Council  Directive  amending  Directive  89/398/EEC  on 
the approximation of the laws of the Member States relating to foodstuffs  intended for particular 
nutritional  uses4  and  in  accordance  with  Article  189A  of  the  EC  Treaty,  the  Commission  has 
decided to amend the above proposal as follows : 

Original proposal 

Amended proposal 

1. The following new recital is added after the 
first  recital : 

the  Commission 

Whereas  an  agreement  on  a  'modus  vivendi' 
between the European Parliament, the Council 
and 
the 
implementing  measures  for  acts  adopted  in 
accordance  with  the  procedure  laid  down  in 
Article  189b of the EC Treaty was reached on 
20 December 1994 

concerning 

2. The second recital is amended as follows : 

Whereas  to  date  such  a  Directive  relating  to  Whereas  to  date  such  a  Directive  relating  to 
infant  formulae  and  follow-on  formulae  has 
infant  formulae  and  follow-on  formulae  has 
been adopted; 
been adopted; 
whereas  there  are  reasons  relating  to  public  whereas  there  are  reasons  relating  to  public 
health  for  adopting  specific  provisions,  in  health  for  adopting  specific  provisions,  in 
accordance  with  Article  4  of  Directive  accordance  with  Article  4  of  Directive 
89/398/EEC,  for  cereal  based  foods  and baby  89/398/EEC, for cereal based  foods  and baby 
foods intended for infants and young children,  foods intended for infants and young children, 
foods  for  weight  control  diets,  foods  for 
foods  for  weight  control  diets  and  foods  for 
special medical  purposes  foreseen  in Annex I  special  medical  purposes  and  foods 
for 
carbohydrate 
to the said Directive; 
persons 
metabolism  disorders  (diabetes"!  foreseen  in 
Annex I to the said Directive. 

suffering 

from 

3  O.J 

4 O.J. N°C108  16.04.1994, p. 17 

low-sodium 

Whereas  the  same  imperative  reasons  for 
adopting  specific  provisions  for  the  other 
to  Directive 
groups 
in  Annex  I 
listed 
foods, 
89/398/EEC  namely 
including  low-sodium  or  sodium-free  dietary 
salts,  gluten-free  foods,  foods  intended  to 
meet  the  expenditure  of  intense  muscular 
effort,  especially  for  sportsmen  and  foods  for 
persons 
carbohydrate 
metabolism disorders (diabetes) cannot be put 
forward;  whereas  such  products  can  be 
adequately  marketed  and  be  efficiently 
monitored  officially 
the  general 
provisions of Directive 89/398/EEC. 

suffering 

under 

from 

3.  The third recital is amended as follows : 

low-sodium 

Whereas  the  same  imperative  reasons  for 
adopting  specific  provisions  for  the  other 
to  Directive 
groups 
in  Annex  I 
listed 
foods, 
89/398/EEC  namely 
including  low-sodium  or  sodium-free  dietary 
salts, gluten-free  foods, and foods  intended to 
meet  the  expenditure  of  intense  muscular 
effort,  especially  for  sportsmen  cannot be put 
forward;  whereas  such  products  can  be 
efficiently 
adequately  marketed  and  be 
monitored  officially  under 
the  general 
provisions  of Directive  89/398/EEC  provided 
that the conditions for the use of certain terms 
used  to  indicate  the  particular  nutritional 
property of products arc defined-

4.  The  following  new  recital  is  added  after 

the last recital 

Whereas  it  remains  possible  tô  harmonise  at 
Community  level  rules  for  other  groups  of 
foods  for  particular  nutritional  uses,  as 
interest  of  consumer 
necessary, 

the 

in 

protection  and 

free  movement  of  such 

foodstuffs, 

Article \ 

Directive 89/398/EEC is amended as follows : 

1. The  following  article  4a  is  inserted  in 

directive S9/398/EEC 

"Article 4a 
The  conditions  under  which  the  terms 
concerning 

-  reduction  or  absence  of  sodium  (salt) 

content 

-  absence of gluten (gluten  free) 
may  be  used  to  describe  the  products 
referred  to in Article  1 shall  be adopted  in 
accordance  with  the  procedure  laid  down 
in Article 13" 

Annex  I  to  directive  89/398/EEC_ojUhe_  2.  Annex I to directive 89/398/EEC  is hereby 
approximation  of  the  laws  of  the  Member 
States  relating  to  foodstuffs  intended  for 
particular  nutritional  uses 
is  hereby 
replaced by the following : 

replaced by the following : 

"ANNEX 1 

"ANNEX 1 

Groups  of  foods  for  particular  nutritional 
uses  for  which  specific  provisions  will  be 
laid down by specific directives1 

Groups  of  foods  for  particular  nutritional 
uses  for  which  specific  provisions  will  be 
laid down by specific directives1 

1.  Infant formulae and follow-on  formulae 
2.  Cereal based foods and baby foods 
3.  Food intended for weight control diets 
4.  Dietary 

for  special  medical 

foods 

1.  Infant formulae and follow-on  formulae 
2.  Cereal based foods and baby foods 
3.  Food intended for weight control diets 
4.  Dietary 

for  special  medical 

foods 

purposes 

purposes 

5.  Foods 

for  persons  suffering 

carbohydrate  metabolism 
(diabetes) 

from 
disorders 

It is understood that products already on the market when 

1 

It  is understood  that  products  already  on  the  market 

the Directive is adopted will not be affected  by it" 

when the Directive is adopted will not be affected  by 

C 

ISSN 0254-1475 

COM(95) 588  final 

DOCUMENTS 

EN 

06  10 

Catalogue number  : CB-CO-95-621-EN-C 

ISBN 92-77-96412-X 

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