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 uses
Date: 1994-12-16
Institutions: European Commission
Subjects: approximation of laws, consumer protection, foodstuff, foodstuffs legislation, human nutrition, labelling

COMMISSION  OF THE  EUROPEAN  COMMUNITIES 

COM(94) 600  final 

B r u s s e l s,  16.12.1994 

94/0327  (COD) 

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  uses 

(presented  by  the  Commission) 

EXPLANATORY  MEMORANDUM 

Justification  of the proposal  in terms  of  subsidiarity 

1.  What are the objectives of the proposed measure with regard to the Community's 

obligations? 

the 

from 

The  specific  directives  which 
framework  Council 
follow  on 
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  uses  contain 
provisions  on the  composition  of  the  dietary  products  in  question.  Amendments  to 
these  directives,  including  updates  allowing  for  technological  innovation,  have  to be 
approved  in accordance with the procedure of the Standing Committee for  Foodstuffs 
(regulatory  committee  Ilia)  and  require  consultation  of  the  Scientific  Committee  for 
Food.  This  procedure  takes  so  long  that  the  industries  which  have  produced 
innovations  are  unlikely  to benefit  fully  from  their  research,  since their  competitors 
have  plenty  of  time  to  adapt  their  products  to  the  new  composition  rules  before  the 
law can be amended  to enable the products to be marketed.  This proposal  introduces 
a procedure by which temporary  marketing authorizations can be granted  for  products 
resulting from  such  research.  This should  enable industries to enjoy  a return on their 
efforts  to develop improved  products, of which consumers are the main  beneficiaries. 
The procedure should also ensure that European industry is competitive at world level 

2. 

Does competence  for  the  proposed  measure lie solely  with  the  Community  or is 
it shared  with  the  Member  States? 

This  sector  is  being  harmonized  at  Community  level,  so the  proposed  measure  falls 
within  the exclusive  competence  of the  Community. 

3. 

To what  extent  is this a problem  on  a Community  scale? 

Given  that  the  proposal  is  designed  to  ensure  that  Community  rules  do  not  hamper 
innovation  in  the  products  sector  of  European  industry,  this  is  a  problem  on  a 
Community  scale. 

4.  What is the most effective solution taking into account  the means available to the 

Community  and  the Member  States? 

Since  it  is  impossible  to  guarantee  shorter  deadlines  for  the  directive  adaptation 
procedure,  the  most  effective  solution  is  temporary  authorization  to  market  new 
products resulting  from  innovation  pending the adaptation  of Community  law and its 
transposition  into national  law. 

However, such marketing authorization  could be granted only after  consultation of the 
Scientific  Committee  for  Food  to  check  that  the  proposed  technological  innovation 
does  not  pose  a  risk  to  consumer  health. 
In  addition,  Member  States  would  be 
consulted  through  the  Standing  Committee  for  Foodstuffs  to  determine  the  sort  of 
reception  which  would  be given to the draft  modification  of the Directive concerned 
This would  have to be submitted  to the Committee  as soon  as possible following  the 
temporary  authorization  decision 

An alternative  solution  would  have been  to allow  Member  States to grant  temporary 
marketing  authorizations.  However,  such  authorization  could  be  granted  only  in 
respect  of the national  territory  of the  Member  State concerned,  and  this would  have 
created  new  barriers  to the free  movement  of  foodstuffs. 

5.  What  practical  additional  benefit  will  the  proposed  measure  provide  and  what 

would  be the  cost  of  failure  to  take  action? 

The proposed measure will enable firms which manufacture  dietary  products to derive 
proper  benefit  from  their  research  by  allowing  them  sufficient  time  to  put  their  new 
products  on  the  market  without  being  faced  immediately  by  their  competitors,  who 
currently  exploit  the  lengthiness  and  transparency  of  the  procedure  to  adapt  their 
product range and incorporate other people's innovations into it  Lack of action would 
discourage these firms from  carrying out research  in the sector, given the cost of such 
research  and the lack  of any  potential  benefit.  This situation  would be prejudicial  to 
the  consumer,  who is the  main  beneficiary  of technological  innovations. 

6.  What  forms  of  action  are open  to the  Commission? 

Framework  Directive 89/398/EEC will  have to be amended to enable the Commission 
to grant  temporary  marketing  authorizations. 

7. 

Is it absolutely necessary to adopt uniform  rules or would a directive establishing 
general  principles  and  leaving  implementation  to  the  Member  States  be 
sufficient? 

Since  the  idea  is  to  introduce  a  Community  procedure  for  temporary  marketing 
authorization, the only solution is to amend Directive 89/398/EEC, adding a provision 
which  lays down  the precise  conditions  for  granting  authorization. 

Proposal  for  a 
EUROPEAN  PARLIAMENT  AND COUNCIL  DIRECTIVE 
amending  Directive  89/398/EEC 
on the approximation  of  ilie laws of  the  Member  States relating  to 
foodstuffs  intended  for  particular  nutritional  uses 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article  100a thereof, 

Having  regard  to the  proposal  from  the  Commission0\ 

Having  regard  to the opinion  of the Economic  and  Social  Committee(2), 

Acting  in  accordance  with  the  procedure  referred  to  in  Article  189b of the  Treaty, 

Whereas  Article 4  of  Council  Directive  89/398/EEC(3)  provides  that  specific  provisions 
applicable  to  the  groups  of  foodstuffs  appearing  in  Annex  I  thereto  must  be  laid  down  by 
means of  specific  Commission  directives; 

Whereas those specific  directives reflect  the state of knowledge at the time of their adoption; 
whereas, therefore,  any  amendment  to  include  innovations  based  on  scientific  and  technical 
progress  must  be  approved  in  accordance  with  the  procedure  laid  down  in  Article  13  of 
Directive  89/398/EEC; 

Whereas this  procedure,  which  includes  consultation  of  the  Scientific  Committee  for  Food 
and  requires  a favourable  opinion  from  the  Standing  Committee  for  Foodstuffs,  means that 
the period  after  which  a specific  directive  can be  amended  is relatively  long; 

Whereas the length  of the procedure  reduces the opportunity  available to the industry  which 
has produced  the technological  innovation  to benefit  from  the  fruits  of  its  research; 

Whereas  a  procedure  must  be  laid  down  which  allows  the  foods  resulting  from  these 
innovations  to  be  marketed  on  a  temporary  basis  pending  the  amendment  of  the  specific 
directive  concerned; 

Whereas, however, on the grounds of consumer health protection, marketing authorization can 
be granted  only  after  consultation  of the  Scientific  Committee  for  Food; 

Whereas  authorization  can  be granted  only  if the product  poses  no danger  to human  health, 

(1) 
(2) 
(3) 

OJ No 
OJ No 
OJ No L  186, 30.6.1989,  p. 27. 

HAVE  ADOPTED  THIS  DIRECTIVE: 

Article 1 

In  Article 4 of Directive  89/398/EEC, the following  paragraph  1A is added: 

"1A  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  Scientific  Committee  for  Food  and  the 
Member  States represented  within  the  Standing Committee  for  Foodstuffs,  authorize 
for  a two-year period the marketing  of food  which  does not  comply  with the rules as 
to  composition  laid  down  by  the  specific  directives  referred  to  in  Annex  I.  Where 
necessary,  the  Commission  may  include  in  the authorization  decision  labelling  rules 
relating  to the change  in  composition." 

Article 2 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative  provisions 
necessary  to comply with  this Directive by 30 September  1997  They  shall  forthwith  inform 
the Commission  thereof. 

When Member  States adopt these provisions, these shall  contain  a reference  to this Directive 
or  shall  be  accompanied  by  such  reference  at  the  time  of  their  official  publication.  The 
procedure  for  such  reference  shall  be adopted  by  Member  States. 

Article 3 

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

This Directive is addressed to the Member States. 

Article 4 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

ISSN 0254-1475 

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