Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE amending Council Directive 89/398/EEC on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses
Date: 1994-03-28
Institutions: European Commission
Subjects: approximation of laws, baby food, cereal product, dietary product, processed food product

COMMISSION OF THE EUROPEAN COMMUNITIES 

C0M(94) 97 final 
Brussels, 28.03.1994 

94/0076 (COD) 

Proposal  for a 

EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 

amend Ing Counc M  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 

1.  MOTIVATION FOR THE PROPOSAL  IN TERMS OF SUBSIDIARITY 

1.  What are the objectives of the action envisaged  In relation to 

the obligations of the Community? 

At  the European Council  held  In Edinburgh on  11-12 December 1992, 

the Heads of State and Government took note of the  intention of the 

Commission  to  reconsider  the  need  for  certain  legislative 

initiatives which  had  previously  been  envisaged  (Part  A,  Annex  2 

section  3  of  the  Presidency  conclusions).  In  particular,  the 

Commission announced that  it would review the need to bring forward 

legislation  in respect of dietetic foodstuffs. The present proposal 

is  intended  to fulfil  the undertakings given by  the Commission  in 

this respect. 

2  Does the action envisaged result from an exclusive Community 

competence or  a  competence which  Is shared  between  the Community 

and the Member States. 

The  action  envisaged  results  from  an  exclusive  Community 

competence. 

3.  What  Is the Community dimension of the problem 

As  part  of  the  White  Paper  programme  for  the  realisation  of  the 

internal  market,  Council  Directive  89/398/EEC  of  3  May  1989  on 

foodstuffs  for particular nutritional uses has harmonized  the  laws 

of the Member States relating to dietetic foodstuffs. The Directive 

lays down the definition of the products concerned  and a number of 

very  important  provisions concerning  their  labelling, presentation 

and advert ising. 

In accordance with Article 9, when a new dietetic food  is placed on 

the market  for  the first  time  in a Member  State, the manufacturer 

or  importer  from  a  third  country  is  required  to  notify  the 

competent  authorities  of  the  Member  State  concerned,  and  provide 

them 

with 

a 

copy 

of 

the 

labelling. 

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The  manufacturer  is  obliged  to  keep  at  the  disposal  of  the 

competent  authorities  a  file  with  the  scientific  work  and  data 

establishing  the  product's  compliance  with  the  definitions  and 

labelling.  Should  a  Member  State  oppose  the  marketing  of  the 

foodstuffs concerned, a safeguard clause requires the Member  State 

to notify the Commission, and provides a basis for a decision to be 

taken at Community level. 

The  Annex  of  the  Directive  lists  a  series  of  9  categories  of 

dietetic  foodstuffs  which  are  to  be  the  subject  of  specific 

Community directives to be adopted by the Commission  in accordance 

with  a  regulatory  committee  procedure.  Until  such  time  as  these 

directives  are  adopted,  the  Member  States  may  maintain  In  force 

specific  national  rules  for  the  products  concerned.  Thus  the 

Directive does not provide a proper basis for the free circulation 

of these products. 

The  9  categories  of  dietetic  foodstuffs  listed  in  the  Annex  of 

Directive 89/398/EEC which are to be covered by specific directives 

are : 

infant formulae 

follow up milk and other follow-up foods 

baby foods 

low energy and energy reduced foods intended for weight control 

dietary foods for special medical  purposes 

low-sodium  foods,  Including  low-sodium  or  sodium-free  dietary 

salts 

gluten free foods 

foods  intended  to  meet  the  expenditure  of  intense  muscular 

effort, especially for sportsmen 

foods  for  persons  suffering  from  carbohydrate  metabolism 

disorders (diabetes). 

In accordance with the procedure  laid down  In Directive 89/398/EEC, 

the Commission  has already  adopted one Directive which  covers the 

first  two  categories  mentioned  above;  Directive  91/321/EEC  on 

Infant formulae and follow on formulae. 

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4.  What  Is the most efficacious solution  in comparison with  the means 

available to the Community and those cf the Member states? 

When  It  adopted  Directive  89/398/EEC,  the  Council  considered  that 

specific  legislation was required at the Community  level  In respect 

of all 9 categories of dietetic  foodstuffs mentioned  in the Annex. 

Following  a  full  reappraisal  of  the situation  In the  light  of  the 

experience  acquired  since  the  adoption  of  the  Directive,  and  in 

line with  the  conclusions  of  the  Edinburgh  summit,  the  Commission 

Is now of  the opinion  that  the number of specifIc Direct Ives should 

be  limited to four categories of products: 

infant  formulae  and  follow-on  formulae  (already  covered  by 

Directive 91/321/EEC) 

cereal  based foods and other baby foods^*) 

foods for weight  control  diets (*) 

dietary  foods for special medical purposes. 

For  these categories of product, which constitute the whole or part 

of  the  diet  for  potentially  vulnerable  groups  of  the  population 

over  a  substantial  period  of  time,  the  Commission  considers  that 

further  legislation  Is  necessary  in order  to  harmonize  essential 

requirements  linked  with  the  protection  of  public  health.  In  the 

absence  of  harmonized  provisions,  Member  States  will  adopt 

divergent positions which could not effectively be resolved  through 

the  general  provisions  of  Directive  89/398/EEC.  The  consultations 

undertaken  by  the  services  of  the  Commission  show  that  this 

assessment,  which  is  explained  in  Part  2,  is  shared  by  a 

substantial  majority  of  the  Member  States  and  by  the  industrial 

groups concerned. 

The  Commission  therefore  intends  to  resume  preparatory  work  on 

these  texts with  a view  to the adoption of  the  relevant  provisions 

as soon as possible. 

On  the  other  hand,  the  Commission  has  concluded  that  further 

Community  legislation  Is  not  necessary  for  the  four  other 

categories  of  products  mentioned  In  the  Annex  of  Directive 

89/398/EEC, namely : 

_4. 
(*)  The  titles  of  these  two  categories  have  been  changed  in order  to 

clarify  their scope. 

low sodium  foods,  Including  low-sodium  or  sodium-free  dietary 

salts 

gluten free foods 

foods  Intended  to  meet  the  expenditure  of  intense  muscular 

effort, especially for sportsmen 

foods for diabetics. 

For these other categories of products, the general  rules contained 

In  Directive  89/398/EEC  constitute  a  sufficient  basis  of 

harmonisation. 

The reasons for  these conclusions are also given  In greater detail 

In Part 2. 

The deletion of  these 4 categories of dietetic foodstuffs from the 

Annex will have the following consequences : 

the  Commission  will  no  longer  benefit  from  a  delegation  of 

powers from the Council  to adopt specific directives in respect 

of them; 

the normal  regime for the free movement of dietetic foodstuffs 

set out  In Directive 89/398/EEC will apply; thus Member  States 

will be required to dismantle any specific national  regulations 

governing  the products concerned which would  Impede their  free 

circulation,  such  as  authorization  procedures  or  specific 

compositional requirements. 

5.  What  Is the concrete added value provided by the action envisaged 

by the Community and what would be the cost of  Inaction? 

The  action  proposed  by  the  Commission  will  clarify  the  legal 

situation  in  respect  of  the  9  categories  of  dietetic  foodstuffs 

concerned.  In  the  absence  of  further  legislation,  economic 

operators  will  be  uncertain  as  to  whether  further  specific 

legislation  will  in  fact  be  adopted  In  respect  of  the  different 

categories of foodstuffs concerned. 

Moreover, as noted above, unless action  Is taken to amend the Annex 

to Directive 89/398/EEC, those categories of products  in respect of 

which the Commission does not  intend to make further proposais will 

be denied the benefits of the single market. 

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6.  What methods of action are available to the Community? 

For  the  reasons  given  above,  It  is necessary  to  amend  Directive 

89/398/EEC by a further Council Directive 

7.  Are  uniform  rules  necessary,  or  would  a  directive  setting  out 

general  principles and  leaving the  Implementation to Member States 

be sufficient? 

As noted above, for  infant formulae and follow on formulae, cereal 

based  foods and other  baby  foods, energy  reduced  foods for weight 

control  diets  and  foods  for  special  medical  purposes,  detailed 

Community rules are considered necessary. These rules would however 

be  limited  to  the  essential  requirements  necessary  for  the 

protection of public health. 

In  other  cases,  a  reference  to  the  general  rules  laid  down  In 

Directive 89/398/EEC  Is considered sufficient. 

B. SPECIFIC COMMENTS 

1.  Following the conclusions of the European Council held at Edinburgh 

on  11-12  December  1992, the  Commission  has  undertaken  to  review 

whether  It is necessary to proceed with the preparation of detailed 

Community  legislation  for  ail  groups  of  products.  Following  this 

review, the Commission  Is now proposing that  in addition to infant 

formulae  and  follow-on  formulae  (already  covered  by  Directive 

91/321/EEC) the number of groups of products should  be reduced  to 

three namely : 

cereal  based  foods  and  baby  foods  Intended  for  infants  and 

young chiIdren 

foods  intended for weight control diets 

dietary foods for special medical purposes 

The Commission considers that further specific  legislation relating 

to  each  of  these  categories  of  products  is  necessary  for  the 

fol lowing reasons 

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cereal  based  foods  and  baby  foods  Intended  for  Infants  and 

young  children  ;  these  are  products  Intended  for  weaning 

children,  are  used  as  part  of  a  diversified  diet  and  do not 

constitute the sole source of nourishment  for that group of the 

population.  However  when  they  are  used  they  contribute  a 

substantial  part  of  their  diet.  Therefore  their  composition 

must  comply  with  certain minimum  requirements  in order  to be 

appropriate  for  and  satisfy  the  nutritional  requirements  of 

Infants and young children.  In addition appropriate  information 

for  the  nature,  composition  and  use  of  these  products  are 

essential. The  adoption of  Community  rules on  the  above will 

ensure the free circulation of these products. 

foods for weight control diets ; these are specially formulated 

products which are used by a  large number of the persons. They 

can be used  to replace on or more meals while  the rest of the 

daily  diet  Is covered by normal  foods or  they  can  replace the 

whole  of  the  daily  diet  in which  case  they  become  the  sole 

source  of  nourishment.  The  time  period  during  which  these 

products can be used may vary from days to weeks. Therefore the 

same arguments as above are applicable as to the necessity for 

Community  rules on the essential  composition and  labelling for 

these products. 

foods for special medical purposes ; such products are used for 

the dietary  management  of  specific metabolic or physiological 

conditions. There  Is a  large range of  such products which are 

being  developed  by  Industry  in  close  collaboration  with  the 

medical  and  other  related  professions  and  which  are  used  or 

should  be used  under  close  medical  supervision.  It  is also a 

category of products the composition of which  is in continuous 

evolution  In order  to  follow  scientific developments. Because 

of  the  nature  of  these  products  their  misuse  can  present 

certain health risks. For these reasons  it would be appropriate 

to adopt specific  labelling provisions for these products. 

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2.  On  the  other  hand,  the  Commission  considers  that  the  correct 

application  of  the  provisions  laid  down  In Directive  89/398/EEC, 

together  with  the  provisions  on  nutritional  labelling  for 

foodstuffs  laid  down  by  Directive  90/496/EEC  should  provide  a 

sufficient  basis  for  the free circulation of  the other  categories 

of  products,  and  that  there  Is  no  need  for  futher  specific 

directives  on  these  products,  it  Is  obvious  that  national 

provisions applicable  to such producgts will have to be abolished. 

The reasons for these conclusions are as follows ; 

Low sodium foods  ; the Commission accepts  that  there may be a 

need to define terms such as "low sodium" and  "reduced sodium" 

and the circumstances under which such terms may be used on the 

labelling. The Commission notes also that such  terms are being 

used  for  both  foods  for  particular  nutritinal  uses  and  for 

ordinary foods. Definitions and  limits have been recommended by 

the  Scientific  Committee  for  Food  and  are  discussed  at 

international  level  (Codex  AIimentarlus).  The  Commission  is 

currently  examining  the  possible  actions  to  be  taken  for 

defining  these terms at Community  level. There  is therefore no 

need  for  a  further  specific  directive  on  this  category  of 

foodstuffs. 

Gluten free foods  ; the essential  feature of these products is 

the complete or  virtual  (only  traces) absence of  gluten which 

Is vital  for a proportion of the population. Whether for common 

or  for  dietetic  foodstuffs  It  is  necessary  to  define  the 

conditions under which  the term  "gluten free" can be used. The 

definition  of  these  conditions  however  will  be  sufficient  to 

characterise  these  products  and  therfore  renders  the  adoption 

of  a specific  directive unnecessary. The  scientific basis for 

defining  these  conditions  is  not  yet  available  to  the 

Commission.  The  necessary  action  will  be  taken  when  this 

scientific work has been completed. 

-8-

Foods  for  diabetics  ; these  products  are  intended  for  use by 

persons who are usually aware of the nutritional  needs arising 

from  their  specific  metabolic  problems  and  of  the  dietary 

managment  of  them. Therefore  information on  the nature of  the 

product  and on  Its nutritional  content  as provided  for by the 

framework  directive  89/398/EEC  Is the most  important element. 

Therefore  the  Commission  considers  that  no  further  specific 

provisions need to be adopted. 

Foods  for  sportsmen  ;  these  products  belong  to  a  fast 

developing  and  diversified  group.  Their  composition  varies 

according  to  the  specific  need,  i.e.  muscle  building, short 

effort,  endurance,  etc.  and  can  emphasise  the  protein, 

carbohydrate,  vitamin  or  mineral  content  with  intermediate 

combinations.  The  labelling  rules  provided  In  the  framework 

directive are again, to the Commission's opinion, sufficient to 

inform  the  potential  users  of  the  particular  nutritonal 

properties  of  the  products  and  their  use  and  the  adoption of 

further specific measures are considered unnecessary. 

It should be again stressed  that products that will not be the subject 

of specific directives will  have to comply with  the rules of directive 

89/398/EEC.  Therefore  their  efficient  official  monitoring  will  be 

ensured  through  their  notification to the competent  authorities of the 

Member  States  In  accordance  with  article  9  of  that  directive.  In 

addition  article  11 of  the same directive  (safeguard  clause) provides 

for  the  procedure  to  be  followed  when  Member  States  have  detailed 

grounds for establishing that a product  is not a dietetic product or It 

endangers human health. 

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Proposal  for a Directive of  the European Parliament  and  the Council 

amending Council  Directive 89/398/EEC 

on  the approximation of  the  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  Commission/1) 

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

Acting  in accordance with  the procedure  referred  to  in Article  189 B of 

the Treaty  establishing  the European  Community, 

Whereas  Article  4  of  Directive  89/398/EEC  on  the  approximation  of  the 

laws  of  the  Member  States  relating  to  foodstuffs  intended  for 

particular 

nutritional 

uses  provides  that  specific 

provisions 

applicable  to  the  groups  of  foods  appearing  in Annex  I shall  be  laid 

down by means of  specific Commission Directives ; 

Whereas  to  date  such  a  directive  relating  to  infant  formulae  and 

follow-on  formulae  has  been  adopted  ;  whereas  there  are  reasons 

relating  to  public  health  for  adopting  specific  provisions,  in 

accordance  with  article  4  of  Directive  89/398/EEC,  for  cereal  based 

foods and  baby  foods  intended  for  infants and  young  children,  foods for 

weight  control  diets and  foods  for  special  medical  purposes  foreseen  in 

Annex  I of  the said  Directive ; 

(1) 

(2) 

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Whereas the same  Imperative reasons for adopting specific provision for 

the other groups  listed  in Annex  I of Directive 89/398/EEC namely  low-

sodium  foods,  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 

suffering  from  carbohydrate metabolism  disorders  (diabetes) cannot  be 

put  forward  ; whereas such products can be adequately  marketed  and be 

efficiently  monitored  officially  under  the  general  provisions  fo 

Directive 89/398/EEC. 

Whereas  the  deletion  of  these  categories  from  Annex  I of  Directive 

89/398/EEC  would  be  in  line  with  the  desirability  to  avoid 

unnecessarily detailed  legislation ; 

HAVE ADOPTED THIS DIRECTIVE : 

Article 1 

Annex  I of Directive 83/398/EEC on the approximation of the laws of the 

Member  States  relating  to  foodstuffs  intended  for  particular 

nutritional  uses  is hereby replaced by the following : 

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"ANNEX I 

Groups of foods for particular nutritional uses for which 

specific provisions will be laid down by specific directives  (*) 

1.  Infant formulae and follow-on formulae 

2.  Cereal-based foods and baby foods 

3.  Food  intended for weight control diets 

4.  Dietary foods for special medical purposes 

(*)  It  Is  understood  that  products  already  on  the  market  when  the 

Directive  is adopted will not be affected by it". 

Article 2 

1.  Member  States  shall  bring  Into  force  the  laws,  regulations  and 

administrative provisions necessary  to comply with  this Directive. 

They  shall  immediately  inform  the  Commission  thereof.  Those 

provisions shall be applied  in such a way as to : 

permit  trade  in  products  complying  with  this  Directive  by 

(1) 

prohibit trade  In products not complying with this Directive by 

(2) 

(1) 12 months following adoption 

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2.  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 adoted by member States. 

Article 3 

This Directive Is addressed to the Member States 

Done at Brussels, 

For the European Parliament 

For the Council 

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