The general principles of food law in the European Union - Commission Green Paper
Date: 1997-04-30
Institutions: European Commission
Subjects: approximation of laws, common agricultural policy, consumer protection, foodstuffs legislation, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 30.04.1997 
COM(97) 176 final 

THE GENERAL PRINCIPLES  OF FOOD LAW 

IN THE EUROPEAN UNION 

Commission  Green  Paper 

TABLE OF CONTENTS 

Executive Summary 

Parti 

Introduction 

1. 

2. 

3. 

3.1 

3.2 

3.3 

4. 

5. 

General remarks 

The economic context 

Development of Community activities in the foodstuffs  sector 

The Common agricultural policy and foodstuffs  legislation 

The Common Fisheries Policy 

Development  of the internal market in processed foodstuffs 

The industrial policy dimension 

The consumer, food  safety  and health protection 

Part II 

Simplification  and Rationalisation  of Community Food Law 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

Introductory remarks 

General considerations 

General regulatory  approach 

Role of self-regulation  in the foodstuffs  sector 

Horizontal or vertical approaches to food  law 

Subsidiarity and legislative simplification 

National legislative initiatives 

Need for further  legislation to complete the internal market 

Part III  Review  of existing Community legislation 

1. 

2. 

3. 

4. 

5. 

5.1 

5.2 

6. 

7. 

8. 

Review of Community decision-making procedures 

Transparency of Community legislation 

Use of the regulation as an alternative to directives 

Up-dating legislation to take account of technical 
and scientific  progress 

Rationalisation  of definitions used in Community 

foodstuffs  legislation 

Definition  of foodstuff. 

Definition  of placing on the market 

Food hygiene 

Food  quality 

Food  labelling 

m  -

v 

1 

1 

4 

5 

5 

6 

7 

9 

10 

12 

12 

13 

13 

15 

16 

17 

19 

21 

22 

22 

22 

23 

24 

25 

25 

26 

27 

30 

31 

Part  IV  Maintenance  of a high level of protection 

1. 

2. 

3. 

4. 

5. 

6. 

7 

7.1 

7.2 

8. 

9. 

General considerations 

The role of scientific  advice in the 

preparation of food  safety legislation 

Scientific  cooperation relating to food 

Management  of serious and urgent public health risks 

Radiological emergencies 

Zoonoses 

Introduction  of a general obligation to ensure that food  -

is safe and wholesome 

The current  situation at Community level 

Scope of the general obligation of safety  and wholesomeness 

Application of the principle of product liability 
in the foodstuffs  sector 
Meeting the new aspirations of consumers 

34 

34 

35 

38 

39 

41 

41 

44 

44 

45 

47 
48 

Part  V 

Ensuring  the effective  implementation  of internal  market  rules 

50 

1. 

2. 

3. 

3.1 

3.2 

4. 

5. 

General considerations 

Transposition  and application of Community law 

Control  and enforcement 

Veterinary controls 

Other official  controls of foodstuffs 

Sanctions 

Management  of the internal market in non-harmonized  areas 

Part  VI  The external  dimension 

1. 

2. 

2.1 

2.2 

2.3 

3. 

General  considerations 

The multilateral dimension 

The WTO Agreements 

Developments within the Codex Alimentarius 

The consequences of these developments for the Community 

The bilateral dimension 

50 

50 

51 

52 

53 

55 

55 

57 

57 

58 

58 

60 

:.. 61 

62 

Executive  Summary 

General Background 

1. 

Food  law is a matter  of great  public  concern.  A high  level  of  security  and  effective 
public control is necessary to  ensure that the food  supply is safe  and wholesome  and 
to ensure the effective  protection of the other interests of consumers. 

2.  With  every  household  spending  on  average  about  20%  of  its  disposable  income  on 
food  and drink, the sector is of vital importance to the European  economy.  The  food 
and  drink  processing  industries  alone  employ  some  2.3  million  people,  and  in  1996 
consumption within the Community will reach about ECU 500,000 million. 

3. 

4. 

The volume  of Community legislation  relating to  foodstuffs  has grown  substantially, 
in  particular  as  a  result  of  the  Internal  market  programme  and  the  progressive 
implementation  of  the  Common  Agricultural  Policy.  Today,  the  vast  majority  of 
national  food  legislation  has  been  harmonized  at  Community  level.  Even  in  areas 
which  have  not  been  harmonized,  the  application  of  the  general  Treaty  rules,  in 
particular Articles 30-36, provides a basis for the free  movement  of  foodstuffs. 

The new approach  of the Commission  on scientific  advice and  control,  as laid  down 
in the Communication  on Consumer Health and Food  Safety,  which has followed  the 
decision  on  the  separation  of  responsibilities  for  the  management  of  scientific 
committees,  and  for  control  activities  from  the  responsibilities  of  the  legislative 
departments, is not considered  in this Green Paper,  as it is mainly concerned  with the 
substantive  rules  of  Community  law  applicable  to  the  foodstuffs  sector.  The 
Commission,  as  described  in  the  above-mentioned  Communication,  has  taken 
measures  to  raise  the  performance  of  its  control  services  and  to  strive  for  their 
excellence by ensuring their independence, transparency  and  effectiveness. 

The aims of the Green Paper 

1. 

2. 

3. 

4. 

to  examine the  extent  to which the legislation  is meeting the needs  and  expectations 
of consumers, producers, manufacturers  and traders. 

to  consider  how  the  measures  to  reinforce  the  independence  and  objectivity, 
equivalence  and  effectiveness  of  the  official  control  and  inspection  systems  are 
meeting  their  basic  objectives  to  ensure  a  safe  and  wholesome  food  supply  and  the 
protection  of other interests of consumers. 

to launch a public debate on our food  legislation,  and thereby, 

to  enable  the  Commission  to  propose  appropriate  measures  for 
development  of Community food  law, where necessary. 

the  future 

As  a  starting  point  for  discussion,  the  Green  Paper  identifies  six  basic  goals  for 
Community  food  law: 

1. 

to ensure a high level of protection of public health, safety and the consumer; 

2. 

3. 

4. 

5. 

to ensure the free movement of goods within the internal market; 

to  ensure  that  the  legislation  is  primarily  based  on  scientific  evidence  and  risk 
assessment; 

to  ensure  the  competitiveness  of  European  industry  and  enhance  its  export 
prospects; 

to place the primary responsibility for safe food  on industry, producers and suppliers, 
using hazard  analysis and  critical control points (HACCP) type  systems, which must 
be backed up by effective  official  control and  enforcement; 

6. 

to ensure the legislation is coherent, rational and user  friendly. 

In  order  to  achieve  these  goals,  it  is  necessary  to  ensure  that  our  regulatory  approach 
covers the whole food  chain "from the stable to the table". This gives rise to two issues: 

1. 

2. 

the  extent  to  which  primary  agricultural  production  and  the  processed  foodstuffs 
sector should be brought within the same set of general rules; 

the principle  of producers' liability  for  defective  products  to  be  made  obligatory  for 
primary agricultural production (see Directive 85/374/EEC). 

Simplification  and  rationalisation  of Community  foodstuffs  legislation 

1.  Although desirable objectives,  simplification  and rationalisation  cannot be allowed  to 
result  in  a  reduction  in  the  level  of  protection  of  public  health  or  consumer 
protection.  Since  1985,  the  Commission  has  in  general  limited  its  internal  market 
proposals in the foodstuffs  sector to measures which are necessary for the  protection 
of public health and of consumers. 

2. 

3. 

It is important to ensure that the existing legislation  strikes the right balance between 
general  provisions  and  more  detailed  prescriptive  legislation,  between  the  use  of 
binding  legislation  and  recourse  to  voluntary  instruments  and  between  horizontal 
approaches and specific rules applicable to particular categories of  foodstuffs. 

The  application  of  the  principles  of  subsidiarity  and  legislative  simplification  in this 
area  have produced  mixed  results.  One particular  problem  has been  the  difficulty  of 
ensuring  that  the  practical  application  of the  subsidiarity  principle  does  not  result  in 
the  progressive  dismantling  of  the  internal  market  as  a  result  of  new  national 
legislative initiatives. In addition, the scope of Community legislation  may need to be 
extended  to  cover  certain  areas  where  the  internal  market  does  not  appear  to  be 
functioning  effectively. 

VI 

Review of existing  legislation 

1.  Extensive  consultation  of the  social partners  during the preparation  of legislation  is 
an  important  means  of  ensuring  that  the  legislation  meets  its  goals.  The  social 
partners  could  be  encouraged  to  participate  more  actively  in  the  evaluation  of  the 
costs and benefits of proposed new legislation. 

2.  Greater use of Regulations  instead  of Directives would  increase the transparency  of 
the  legislation  and  avoid  difficulties  arising  from  delayed  or  incorrect  transposition. 
The  Directive,  should  however,  remain  the  instrument  of  choice  for  framework 
legislation. 

3. 

4. 

5. 

•6. 

7. 

There are serious difficulties  in adapting existing legislation to technical and  scientific 
progress which would be reduced by the greater use of simplified  procedures. 

The  existing  definitions  which  are contained  in a variety  of legal  instruments  should 
be  rationalised  and  completed  by  new  definitions  of  foodstuffs  and  placing  on  the 
market. 

In  the  field  of  hygiene,  11  vertical  veterinary  hygiene  directives  co-exist  with  a 
general  directive  on the  hygiene  of  foodstuffs.  The  Commission  has  already  begun 
work  on  the  simplification  of  the  vertical  directives,  but  their  relationship  with  the 
general  directive  must  also be  considered.  Priority  should  be given to  ensuring  that 
there is a coherent and consistent body of Community hygiene rules. This can best be 
achieved  by  the  generalised  application  of  HACCP-type  principles,  and  by  limiting 
detailed  prescriptive  regulations  to  cases  where  they  are  considered  essential.  The 
desire for  consistency  must  also  be balanced  by the  need  to  maintain  the  necessary 
degree of flexibility  in the  design  and implementation  of food  hygiene regulations in 
order  to  ensure  a high  level  of  protection  without  imposing  an unnecessary  burden 
on business. 

In the field of  quality,  it  does  not  appear  that  the  differences  of  approach  resulting 
from  the  different  objectives  of internal  market  and  agricultural  legislation  give  rise 
to problems of incoherence or inconsistency. 

In  the  field  of  labelling,  binding  labelling  rules  should  ensure  that  consumers  are 
provided with  essential information  about the foodstuff  in a user-friendly  manner.  It 
is  necessary  to  strike  a  balance  which  ensures  that  consumers  receive  all  useful 
information,  whilst avoiding unnecessarily detailed  provisions. Manufacturers  should 
remain free to provide additional information  provided  it is not misleading.,  although 
in some cases, legislation may be necessary to govern the provision of this additional 
information.  In  this  context,  the  Green  paper  specifically  invites  comments  on  the 
approach followed  in Community legislation to claims and nutritional labelling. 

- vu -

Maintenance of a high level of protection 

1. 

2. 

3. 

4. 

5. 

6. 

The Treaty requires the Community to  contribute to the maintenance  of a high level 
of protection  of public health, the  environment  and  consumers. In  order to  ensure a 
high level of protection  and coherence, protective measures  should be based  on risk 
assessment,  taking  into  account  all  relevant  risk  factors,  including  technological 
aspects,  the  best  available  scientific  evidence  and  the  availability  of  inspection 
sampling and testing methods. Where a full risk assessment is not possible,  measures 
should be based on the precautionary principle. 

The  importance  of  an  independent  source  of  advice  which  will  command  public 
respect is crucial. The independence and objectivity  of scientific  advice and  scientific 
committees  must  be  guaranteed  at  all  levels.  The  Commission  has  taken  steps  to 
ensure  central  co-ordination  of  the  number,  scope,  composition  and  activities  of 
scientific  committees  so  that  a high  level  of  competence  and  full  consistency  of  its 
scientific  advice  is  ensured  and  the  necessary  resources  are  provided.  Every  effort 
must be made to present scientific  conclusions in a clear and cogent manner. 

Scientific  advice is of primary, but not  exclusive, importance.  Community  legislation 
has  on  a number  of  occasions  recognised  that  other  factors,  in  particular  consumer 
needs  and  concerns,  must  also  be  taken  into  consideration  during  the  decision 
making process. 

The  Community  must  have  adequate  means  to  take  preventative  action  against 
serious  and  urgent  public  health  risks.  The  Commission  has  a  range  of  safeguard 
powers  available,  but  it  is important  to  verify  that  there  are  no  gaps  in the  system. 
There  may  also  be  a  need  to  improve  communication  to  the  public  in the  event  of 
serious risks. 

The Community has a variety of strategies available for  the management  and  control 
of  zoonoses  (eradication,  reduction,  removal,  treatment).  The  Commission  invites 
comments  on  possible  improvements  to  the  arrangements  for  managing  the  risk  of 
zoonoses. 

The  legislation  should  set  out  clearly  the  responsibilities  of  producers,  processors, 
distributors and retailers to  supply safe, wholesome food fit for human  consumption, 
of  specified  quality  and  properly  identified,  as  well  as  the  responsibilities  of  the 
competent  control  authorities.  It  may  be  desirable  to  introduce  general  obligations 
on all economic operators to take all the steps necessary to ensure that  only safe and 
wholesome food  is placed  on the market.  Such obligations would  be independent  of 
consumer rights to redress in the framework of the Directive on liability for  defective 
products. 

7. 

The  extension  of  the  product  liability  directive  to  cover  primary  agricultural 
production  should  improve the  overall  level  of protection  of consumers,  but  should 

Vlll 

not  be considered 
official  control systems. 

,s an alternative to  appropriate  product  safety  rules and  effective 

8.  Recent  developments  have  highlighted  consumer  interest  in  food  production 
methods.  Community  food  legislation1  does  not  require  the  labelling  of  production 
methods  which  do  not  have  an  impact  on  the  food  characteristics  of  the finished 
product. However,  in certain cases, mandatory labelling  schemes may be  considered 
necessary,  such  as the recently  adopted  rules  on the  labelling  of beef.  Moreover,  it 
may  be  necessa:y  to  consider  an  appropriate  framework  for  voluntary  labelling 
schemes designed to address this interest. 

Ensuring the effects  e implementation  of internal market rules 

1. 

2. 

Timely  and  correct  implementation  of  Community  legislation  is  essential  for  the 
effective  operation  of the  internal  market.  Greater  use  should  be  made  of  Standing 
Committees  to  consider  questions  regarding  the  interpretation  of  Community 
legislation,  and  unforeseen  difficulties  which  may  arise  during  its  implementation. 
Consideration  should  be  given  to  the  establishment  of  a  forum 
in  which 
representatives  of  the  Commission,  member  States  and  interested  parties  could 
discuss general issues relating to the implementation of the legislation. 

The  primary  role  of  the  Community  in  the  field  of  control  is  not  to  replace  the 
Member  States, but  to  verify  that the necessary  controls  are being  carried  out  in an 
effective  and  equivalent  manner  throughout  the  internal  market.  The  legislation 
should  provide  for  appropriate  enforcement  and  control  measures.  Whilst  aimed  at 
achieving  a high level  of protection,  control  and  enforcement  measures  should  take 
into account the principle of proportionality and should also provide for the targeting 
of  controls  on  activities  presenting  the  greatest  risk.  Steps  should  be  taken  to 
reinforce  administrative  and  scientific  cooperation between Member  States  and with 
the  Commission  in  order  to  ensure  equivalence  of  enforcement  throughout  the 
Community  and  to  ensure  effective  mechanisms  to  prevent  the  marketing  of  unsafe 
food  and to trace the origins of,  and factors  contributing to, outbreaks of  food-borne 
disease.  The  fifth  Research  Framework  Programme  also  has  a  role  to  play  in  this 
respect.  In  order  to  reinforce  consumer  confidence,  efforts  have  been  made  in  the 
Communication  on  Consumer  Health  and  Food  Safety  to  improve the  transparency 
of the  control  system  at  Community  level,  and  the  need  for  greater  transparency  at 
national level should also be considered. 

3. 

The  sanctions  for  infringement  of  Community  internal  market  legislation  should  be 
equivalent  to  the  sanctions  set  out  in  domestic  legislation,  effective,  proportionate 
and dissuasive. 

l 

Directive 79/112/EEC on the labelling, presentation and advertising of  foodstuffs 
Regulation (EC) n° 374/97 on novel foods and novel food ingredients 

-  IX 

4. 

There are mechanisms for  examining new draft  national legislation,  principally  under 
Directive  83/189/EEC where  it  contains technical  regulations;  the  Commission  also 
ensures  respect  for  the  Community  rules  on  foodstuffs  by  the  investigation  of 
complaints.  The  new  procedure  for  mutual  information  on  national  measures 
derogating from the principle of free movement of goods is also expected to make an 
important contribution in this respect. 

In non-harmonized  areas, the primary instrument  for the management  of the  internal 
market  remains  the  principle  of  mutual  recognition,  which  requires  that  a  Member 
State  should  allow to  circulate freely in its territory goods produced  or marketed  in 
conformity  with  the  rules, tests  or  standards  found  in another  Member  State  which 
offer  an equivalent level of protection to its own rules, tests or standards. 

The External  Dimension 

1. 

2 

The Community is both  a major  importer  and exporter  of food.  As an importer,  the 
Community is obliged to ensure that imported foods meet the same high standards as 
have  been  laid  down  for  Community  production.  As  an  exporter,  the  Community 
must  be  able  to  reassure  governments  and  consumers  in  third  countries  that  food 
produced within the Community may be safely marketed in their countries. 

The  legislation  should  be  compatible  with  the  international  obligations  of  the 
Community,  in  particular  those  arising  under  the  WTO  agreements.  Equally,  the 
Community  must  work  in close partnership  with the Member  States,  producers  and 
industry  to  ensure  that  our  major  trading  partners  are  also  respecting  their 
obligations.  The  Community  should  be  able  to  participate  fully  in  international 
standardisation  activities  relating  to  the  foodstuffs  sector.  Where  possible,  the 
Community  should  negotiate  equivalence  agreements  or  mutual  recognition 
arrangements  with  major  trading  partners  to  ensure  in  all  cases,  a  high  level  of 
protection of the consumer. 

X  -

PART  I 

INTRODUCTION 

1.  General  remarks 

Following  more  than  30  years  of  legislative  activity,  the  great  majority  of  national 
food  law  has been  harmonized  at  Community  level. Recent  studies,  in  particular  the 
study  of  the  Impact  and  Effectiveness  of  the  Internal  market  Programme  on  the 
legislative 
Processed  Foodstuffs  Sector,  have  shown 
programme  in  the  foodstuffs  sector  has  had  a  generally  positive  impact,  although 
some  criticisms  have  been  expressed  of  overly  detailed  legislation,  fragmentation, 
difficulties  of  adapting  the  legislation  to  innovation,  and  problems  in  the  day-to-day 
functioning  of the  internal  market.  In  the  light  of  certain  recent  events,  in  particular 
BSE,  others  have raised  doubts  about  the  capacity  of the  legislation  to  entirely  fulfil 
its  objectives  to  ensure  a  high  level  of  protection  of  public  health  and  consumer 
protection. 

the  Community's 

that 

In  contrast  to  legislation  in  most  of  the  Member  States,  Community  food  law  has 
developed  piecemeal,  over  time,  and  there  is no  central  unifying  text  setting  out  the 
fundamental  principles of Community food  law and  clearly defining  the obligations  of 
In  recent  years,  there  have  been  increasing  calls  for  such  a 
those  concerned. 
legislative  framework,  most  notably  from  the  European  Parliament. 
In  1992,  the 
Commission  invited  three  eminent  food  law  experts  to  consider  the  need  for,  and 
possible  scope  of,  such  a  general  directive. 
In  May  1993,  at  the  request  of  the 
Commission, the European University Institute of Florence organised  a conference  on 
this question bringing together the three experts and representatives from  the Member 
States  and  the  Commission,  from  agricultural,  industrial  and  commercial  interests, 
and from  consumer groups. 

The aim of this Green Paper is to: 

examine the extent to which the legislation is meeting the needs  and  expectations 
of consumers, producers, manufacturers  and traders; 

consider  how  the  measures  to  reinforce  the  independence  and  objectivity, 
equivalence and effectiveness  of the official  systems for  the control  and  inspection 
of foodstuffs  are fulfilling  their objectives; 

invite  a  public  debate  on  our  food  legislation  to  provide  guidance  to  the 
Commission in its future  legislative initiative on food,  and accordingly; 

-1  -

- 

enable  the  Commission  to  propose  measures  allowing,  wherever  possible,  to 
improve  the protection  of public health  laid  down  in its measures  for  the  internal 
market and the common agricultural policy, improve the coherence of Community 
food  law,  consolidate  and  simplify  it,  improve  the  operation  of  the  internal 
market,  and  take  into  account  the  increasingly,  important  external  dimension, 
notably  the  policies  followed  by  our  most  advanced  trading  partners  and  the 
requirements of the WTO agreements. 

The new approach  of the  Commission  on scientific  advice  and  control,  as  laid  down 
in the Communication  on Consumer Health and Food  Safety,  which has followed  the 
decision  on  the  separation  of  responsibilities  for  the  management  of  scientific 
committees,  and  for  control  activities  from  the  responsibilities  of  the  legislative 
departments,  is not  considered  in this Green Paper,  as it is mainly concerned  with the 
substantive  rules  of  Community  law  applicable  to  the  foodstuffs  sector.  The 
Commission,  as  described  in  the  above-mentioned  Communication,  has  taken 
measures  to  raise  the  performance  of  its  control  services  and  to  strive  for  their 
excellence by ensuring their independence, transparency  and  effectiveness. 

Before  considering  the  policy  options  which  are  submitted  for  discussion,  it  is 
important  to reaffirm  the fundamental  goals and achievements  of EC  food  law, which 
should in no way be put into question.  These are : 

the  need  to  ensure  a high  level  of  protection  of  public  health  and  safety,  and  of 
consumer  protection; 

the need to ensure the free  circulation of goods within the single market; 

the  need  for  legislation  to  be  based  primarily  on  scientific  evidence  and  risk 
assessment,  in respect  of our international obligations; 

- 

the  need  to  ensure  the  competitiveness  of  the  European  industry,  allowing  for 
flexible  adaptation of the legislation to incorporate new technical  developments  as 
well as to enhance Community export prospects; 

the need to place  the primary responsibility for  safe food  with industry,  producers 
and  suppliers,  including  imports  from  third  countries,  through  self-checking 
provisions (so-called Hazard  Analysis Critical  Control Points  systems or HACCP) 
backed  up by official  controls and appropriate  enforcement; 

the need  for  legislation  to  be  coherent,  rational,  consistent,  simpler,  user-friendly 
and developed  in full  consultation with all interested parties. 

2-

It  is  also  necessary  to  stress  that  as  the  food  chain  becomes  increasingly  complex, 
with  a  growing  number  of  interventions  from  primary  producers  through  the  agro-
food  industry  to  distributors  and  retailers,  so it becomes  essential  to  ensure  that  our 
regulatory  approach  covers  all  potential  risks  to  the  safety  and  wholesomeness  of 
food,  at  all  stages  of  the  food  chain,  including  factors  arising  upstream,  from 
potentially hazardous inputs or environmental  contaminants; factors  arising during on 
farm  production  and  factors  arising  during  downstream  manufacturing,  processing 
distribution or storage. 

For  this  reason,  a further  objective  of this  Green  paper  is to  examine  whether  or  to 
what  extent processed  foodstuffs  and primary agricultural production  can be brought 
within the scope of the general rules applicable to foodstuffs,  despite their  differences. 
Similarly,  under  the  product  liability  Directive,  it  is  left  to  Member  States  to 
determine whether to  apply product  liability to  primary  production.  The  extension  of 
Community  rules  on  product  liability  to  all  operators  in  the  food  chain,  including 
primary producers is therefore  also considered. 

The  Commission  wishes  to  ensure  that  the  consultation  exercise  covered  by  this 
Green Paper  is as broad  as possible.  It therefore  invites any other  relevant  comments 
and  suggestions  from  interested  parties.  At  the  end  of  the  consultation  process  the 
Commission  will  consider  what  changes  may  be  necessary.  These  changes  may 
consist  of: 

a proposal for a general Directive on food  law; 
consolidation  and  simplification  of  certain  provisions,  or  reformulation  of 
existing legislation; 
suggestions  or  proposals  of  a  non-legislative  nature,  including  changes  in 
procedures or working methods. 

Comments on this Green paper should be addressed  before  31 July  1997 to. 

European  Commission 
Directorate General for Industry (Green Paper  on Food Law) 
200 rue de la Loi (RP  113/1) 
B-1049 Brussels 

-3 

2. 

The economic  context 

Within  the  Community,  every  household  spends  on  average  about  20%  of  its 
disposable  income  on  food  and  drink.  It  is  estimated  that  in  1996  consumption  of 
food  and  drink  and  tobacco  within  the  Community  will  amount  to  about  ECU 
500,000  million,  while  production  will  amount  to  ECU  510,000  million.  The 
Community  is  both  a  major  importer  and  a  major  exporter  of  foodstuffs.  In  1994 
exports  from  the  Community  reached  ECU  34,250  million,  while  imports  into  the 
Community were valued at ECU 24,480 million, leaving a favourable  trade balance of 
ECU  9,770  million,  an  increase  of  over  50%  when  compared  with  1992.  In  some 
food  sectors, however, there is a negative trade balance. For example there is a deficit 
of  fisheries  products  in  the  Community  which  amounted  to  ECU  6,172  million  in 
1994.  Over  2.3  million people are employed  by the food  and  drink  industries,  nearly 
50% of them in enterprises with less than  100 employees. A further  10 million people 
are  employed  in  primary  agricultural  production.  The  food  and  drink  sector  is  thus 
clearly of major importance for the European economy as a whole. 

Between  1984  and  1992 both  production  and  consumption  of food  and  drink  within 
the  EC  grew  at  a  constant  real  rate  of  about  2-2.5%  a  year.  However,  in  1992-93, 
this  rate  of  growth  slowed  to  below  1%. Much  of  this  growth  is  achieved  through 
higher added value, as, particularly in Northern Europe,  consumers  switch  from  fresh 
foodstuffs  to  "convenience"  processed  foods.  The  major  producers  have  reacted  to 
this long-term  change  by investing  heavily in increasing  their  production  capacity,  in 
the  modernisation  of  equipment  and  in new  technology.  Smaller  producers,  on  the 
other hand  are finding  themselves under growing pressure, not  only as a result  of the 
changing  pattern  of foodstuffs  demand, but  also because of the  major  changes  taking 
place  in the  retail  distribution  system,  notably  due to  the  increasing  concentration  in 
food  distribution  and  the growing  role of the supermarkets'  "own-brand"  products in 
the  market  place.  As  a  result,  many  smaller  producers  face  a  choice  of  seeking  a 
niche  in  a  quality  market  or  of  becoming  suppliers  of  "own-brand"  products  for 
supermarkets. 

Across the Community  as a whole, there are still substantial  regional variations in the 
market  for  foodstuffs,  particularly  between  the  northern  and  the  Mediterranean 
regions.  In  Southern  Europe,  consumption  of fresh  food  remains  relatively  high  and 
the  proportion  of  value  added  by  the  food  processing  industry  is  thus  significantly 
lower.  Nevertheless,  in  all  regions  there  has  been  considerable  diversification  of  the 
type  and  range  of  products  available,  and  this  trend  is  likely  to  continue  as 
manufacturers  seek  to  use  the  rules  of the  internal  market  to  obtain  new  outlets  for 
their products. 

- 4-

Against this background, it appears clear that the Community has a major  role to  play 
by  promoting  a transparent  and  stable  regulatory  environment  as the  foundation  for 
further  development  of this vital  sector.  In particular,  the transparency  and  efficient 
operation  of the internal  market  is of major  importance  for  the  survival  of  the  large 
number  of  smaller  and  medium-sized  companies  which  must  increasingly  compete 
with the giants of the multi-national agro-food  industry. 

3.  Background  to the development of Community activities in the foodstuffs  sector 

The  primary  influences  on  the  development  of  the  Community's  food  law  have 
resulted from the Common Agricultural Policy and the programme for  the  realisation 
of the  internal  market.  There  is  also  a  distinct  policy  for  fisheries  and  acquaculture, 
the Common Fisheries Policy. 

For  the  future,  the  development  of  Community  activities  in  this  sector  will  also  be 
strongly influenced  by the new provisions added by the Maastricht  Treaty  concerning 
human  health  protection  (Article  129),  consumer  protection  (Article  129a),  and  the 
environment  (Article 13Or). 

3.1  The Common Agricultural Policy and foodstuffs  legislation 

The  common  agricultural  policy  has  had  a  significant  impact  on  the  development  of 
food  law  within  the  Community.  Measures  taken  to  achieve  the  objectives  of  the 
CAP have inevitably  also resulted  in the development  of legislation which  affects  the 
sale of foodstuffs  of agricultural origin.  Three points in particular may be noted: 

1.  One  of  the  main  features  of  the  CAP  has  been  the  development  of  common 
organizations  of  the  market  for  the  major  agricultural  commodities,  along  with 
price  support  and  intervention  measures  funded  by  the  European  Agricultural 
Guidance  and  Guarantee  Fund  (EAGGF).  For  these  measures  to  operate 
effectively  and  to  avoid  fraud,  it  has  been  necessary  in  some  cases  to  establish 
quality specifications  to  define those products eligible for  support.  In addition,  as 
a  market  support  measure,  and  sometimes  in  the  absence  of  price  support 
mechanisms,  it  has been  considered  necessary  to  lay  down  quality  specifications 
for  products.  The nature and extent of these rules vary according to the  common 
organization  of  the  market  concerned.  In  some  cases  the  rules  may  have  little 
impact  on  the  marketing  of  the  finished  foodstuffs. 
In  others,  for  example  the 
common  organization  for  wine,  the  rules  constitute  a  comprehensive  and  self-
contained  marketing code. 

2.  To  secure free movement  of primary agricultural  produce within the  Community, 
it  has  been  considered  necessary  to  lay  down  detailed  rules  approximating  the 
laws  relating  to  human,  animal  or  plant  health.  For  example,  the  rules  on 
veterinary  hygiene  have  a  profound  influence  on  the  use  and  marketing  of 
foodstuffs  of  animal  origin.  It  is  also  necessary  to  ensure  that  the  techniques 
used  in agricultural  production  do not themselves  present  a risk to  public health. 
Thus, for  example, detailed  provisions have been laid down establishing limits  for 
residues of pesticides or veterinary medicines in  foodstuffs. 

3.  In  its  1989  communication  on  the  future  of  rural  society,  the  Commission 
indicated  its  intention  to  promote  a  product  quality  policy  at  Community  level. 
As a consequence, specific Community legislation has been adopted governing the 
use  of  quality  marks  or  labels to  identify  products  which  are  subject  to  a  special 
production  quality  requirement  (Regulation  2082/92),  originate  in  areas  known 
for  their  traditional  production  (Regulation  2081/92),  or  can  be  shown  to  be 
produced using special methods, such as organic foods. 

More  recently,  there  have  been  several  other  developments  of  importance  for  the 
consumer.  The  Council  has  recently  adopted  binding  rules  on  the  traceability  of 
products  of  bovine  origin,  and  consideration  is  being  given  to  further  measures  to 
improve the traceability of other animal products. Proposals are also in preparation  to 
extend organic labelling to cover foodstuffs  of animal origin. 

3.2  The Common  Fisheries  Policy 

While  the  term  primary  agricultural  production  is  usually  taken  to  include fisheries 
products, fishing  and acquaculture are covered by a quite separate Common Fisheries 
Policy  (CFP).  This  provides  specific  provisions  in  Community  food  law  for  fishery 
products.  The  common  organisation  of  the  market  involves  a  set  of  principles  and 
rules  dealing  with  common  marketing  standards,  producers  organizations,  internal 
market  price support mechanisms  and a régime for  trade with non-member  countries. 
Structural  assistance  mechanisms  for  fisheries  and  acquaculture  are  implemented 
under  the financial instrument  for fisheries guidance  (FIFG),  which  includes  finance 
for  improvement  and  control  of  quality  and  hygiene.  Detailed  rules  relating  to  the 
conservation  of  limited  fish  stocks  are  an  integral  part  of  the  CFP.  The  veterinary 
legislation  applying  to  fish  and  shellfish  is  currently  being  reviewed  as  part  of  the 
project  to  simplify veterinary legislation on products of animal origin. 

3.3  The development  of the internal  market  in processed  foodstuffs 

The  foodstuffs  sector  is  an  essential  part  of  the  internal  market,  both  from  the 
consumer's  point  of view and that  of economic operators. Thus all measures taken  at 
Community  and  national  level  have to  take  full  account  of  the  general  principles  of 
the internal market, and in particular the principle of the free movement of goods. 

The  Community  has  a variety  of instruments  at  its disposal for  the  realisation  of the 
internal market. 

application  of  the  general  principles  governing  the  free  movement  of  goods, 
notably  the  principle  of  mutual  recognition  derived  from  the  case  law  of  the 
Court  of  Justice  (which  requires  that a Member  state  should  allow  to  circulate 
freely  in  its  territory  goods  produced  or  marketed  in  conformity  with  the 
rules,  tests  or  standards  found  in  another  Member  State  which  offer  an 
equivalent  level of protection  to its own rules,  tests or  standards) 

detailed  harmonization  of  national  legislation  in those  cases where  application  of 
the  principle  of  mutual  recognition  does  not  provide  a  sufficient  basis  for  the 
internal market; 

- 

the use of framework  legislation,  setting out certain general principles, but leaving 
Member  States free to  adopt  stricter or more specific  rules, provided these do not 
create unjustified  restrictions on the operation of the internal market; 

- 

the use of voluntary instruments, such as standardization or codes of practice. 

Detailed  harmonization  of  national  foodstuffs  legislation,  in  order  to  secure  free 
movement,  began  in the  earliest  years  of the  Community.  From  1962  to  1985,  two 
approaches were  followed: 

-  horizontal  harmonization  covering  all  foodstuffs,  either  to  protect  public  health 
(e.g.  additives)  or  for  the  protection  of  other  consumer  interests,  such  as  the 
provision  of information  or the prevention of misleading trade practices  (e.g. with 
regard to  labelling) 

-  vertical  harmonization  laying  down  detailed  specifications  for  a  specific  type  of 
foodstuff;  eight  directives  were  adopted  covering  cocoa  and  chocolate  products, 
sugars,  honey,  fruit  juices  and  similar  products,  jams,  jellies  and  marmalades, 
preserved  milk, coffee  extracts and natural mineral waters. 

In addition,  mention  should be made of Council Directive  80/778/EEC on the quality 
of  drinking  water  for  human  consumption.  This  Directive  is  of  fundamental 
importance  for  the  foodstuffs  sector  as  all  water  used  in  a  food  production 
undertaking  for  the  manufacture,  processing,  preservation  or  marketing  of  products 
or  substances  intended  for  human  consumption  and  affecting  the  wholesomeness  of 
the foodstuff  in its finished form must comply with the requirements laid down in that 
Directive. 

Parallel with the legislative development  at Community level, the Court  of Justice has 
interpreted  Articles 30-36 of the EC Treaty. Following the jurisprudence  of the Court 
in the  Cassis  de Dijon  case,  the  Commission  completely  reviewed  its  policy  on  the 
harmonization  of foodstuffs  legislation and in  1985 presented  a communication to  the 
Council and the European Parliament  on the completion of the internal market  in the 
foodstuffs  sector (COM (85) 603 final). At the same time the scope of the principle of 
mutual recognition was  clarified. 

In  accordance  with 
legislation  would 
henceforth  be limited to the harmonization  of national rules justifiable  in terms  of the 
mandatory requirements identified  by the Court, namely: 

the  communication,  Community  food 

the protection of public health; 
the protection of other consumer interests, notably consumer  information; 
fair trading; 
the need to ensure appropriate official  controls. 

- 

- 

On the other  hand, the Commission indicated  that  in principle it would  no  longer  put 
forward  proposals  for  the  harmonization  of  quality  specifications,  such  as  rules 
relating to  the composition  or manufacture  of foodstuffs  which are not  related  to  the 
protection  of  public  health.  Instead,  the  Commission  believed  mutual  recognition 
the  labelling  rules  to  guarantee  consumer 
could  be  achieved  by  reinforcing 
information  and fair trading.  In addition, the Commission  encouraged  the industry  to 
develop quality policies based on the use of voluntary instruments. 

In  a further  communication  of  1989  on  the  free  movement  of  foodstuffs  within  the 
Community  the  Commission  summarized  the  principles  in  this  area  taking  into 
account  the jurisprudence  of the  Court.  In  its  1991 interpretative  communication  on 
the  names  under  which  products  are  sold,  the  Commission  specified  the  system  for 
mutual recognition of foodstuffs  in non-harmonized  areas together with the possibility 
of adopting  sectoral  provisions  considered  necessary  for  the implementation  of  other 
Community  policies,  for  example,  composition  requirements,  definition  of  organic 
production,  quality marks for traditional foods,  and designations of origin. 

Virtually  all  the  legislation  set  out  in  the  Commission's  1985  programme  has  now 
been  adopted,  with  the  exception  of  the  proposals  relating  to  food  irradiation, 
currently  under  consideration  by  the  Council  and  the  European  Parliament. 
In 
addition,  further  measures  have  been  adopted  to  take  account  of  problems  not 
foreseen  in  1985, notably  in respect  of food  hygiene,  contaminants,  and  cooperation 
between  the  Commission  and  the  Member  States  on  the  examination  of  scientific 
questions relating to  food. 

Since  1 January  1989,  Member  States  have  been  required  to  communicate  to  the 
Commission, under the procedure for the provision of information  set out in Directive 
83/189/EEC,  draft  technical  regulations  relating  to  foodstuffs.  Further  specific 
notification  procedures  apply  to  national  measures  concerning  food 
labelling, 
contaminants and food  hygiene. These are described in Part 2, section 7. 

Finally,  consideration  must  be  given  to  the  fact  that,  in  areas  not  covered  by 
Community  legislation,  the  developing  case  law  of  the  Court  of  Justice  provides  a 
continuing basis for the free movement of  foodstuffs. 

4. 

The industrial  policy  dimension 

In  section  2,  it  was  noted  that  primary  agricultural  production,  and  the  processed 
food  and  drink  sectors,  are  of  major  importance  to  the  European  economy.  It  is 
important,  therefore,  to  maintain the  competitiveness  of  these  sectors  as  a  means  of 
achieving  rising  living  standards  and  social  welfare  across  the  Community.  In  its 
recent  Communication  on Benchmarking  the  competitiveness  of  European  industry, 
the  Commission  indicated  that  the  primary  responsibility  for  ensuring  that  firms 
remain  competitive  remains  with  the  firms  themselves.  Nevertheless,  the  public 
authorities  sustain  competitiveness  by  putting  in  place  the  appropriate  framework 
conditions  under  which  enterprises  operate,  notably  by  providing  the  necessary 
infrastructure,  putting  in  place  an  appropriate  regulatory  environment  and  specific 
initiatives,  particularly  in  the  areas  of  innovation,  quality,  the  business  environment 
for  small  and  medium  sized  enterprises  and  economic  cohesion.  In  this  context,  the 
Commission has recently taken a series of general initiatives, such as the Green Paper 
on Innovation, the working document  on quality and the Multi-annual  programme  for 
SMEs,  which  are  equally  relevant  to  the  foodstuffs  sector.  Certain  of  these  issues, 
such as the need to ensure an appropriate regulatory environment,  which is conducive 
to innovation,  are touched  on at various points in this Green Paper.  The  Commission 
considers  that  it  is  important  to  ensure  that  these  industrial  policy  orientations  are 
integrated  into  its  regulatory  approach  to  the  foodstuffs  sector,  and  it  would  invite 
comments on any further  measures which may be necessary in this respect. 

5. 

The consumer, food  safety  and  health  protection 

As the previous sections have shown,  Community rules applicable to  foodstuffs  have 
developed  from  the  variety  of  different  legal bases  set  out  in  the  treaty,  in  order  to 
serve different  policy objectives. The legislation is also based on a complex division of 
responsibilities  between  the  Commission  and  the  Member  States.  The  situation  is 
complicated  and  difficult  to  understand,  not  only  for  the  average  citizen,  but 
sometimes also for the specialist.  This has led to criticisms that  the  Community  lacks 
a coherent  policy towards the foodstuffs  sector  as a whole, and  approaches  problems 
piecemeal. The general remarks at the beginning of this Part  have identified  a number 
of common goals which run all the way through Community food  law. 

The BSE  crisis has highlighted  the  need  for  a European  food  policy  centered  on  the 
requirement  that  only foodstuffs  which  are  safe,  wholesome  and fit for  consumption 
be placed  on the market. Health protection in relation with consumption of  foodstuffs 
is to  be  an  absolute  priority  at  any  time  and  not  only  something  to  be  looked  at  in 
emergency situations. 

The Commission has already taken steps to adapt the structure of its services, so as to 
make it possible to fully reach this objective. 

The  Commission  intends  to  develop  a  true  food  policy  which  attaches  fundamental 
importance to the protection of the consumer and his health. 

In  order  to  build  an  effective  food  safety  policy,  major  efforts  will  be  deployed  in 
order to ensure that: 

- 

the  most  recent  and  complete  scientific  evidence  is  taken  into  account  when 
deciding on legislative or other measures; 

-  a  precautionary  approach  is  the  rule  in  case  scientific  evidence  is  incomplete  or 
unconvincing one way or the other which makes a full risk assessment impossible; 

-  at  all  stages  of  the  food  chain,  there  is  clear  responsibility  for  the  safety  and 
wholesomeness  of food.  This implies corresponding  provisions for  liability  in case 
of damages caused to the consumer's health by unsafe  or unwholesome  food; 

-  control measures are taken at all critical points throughout  the food  chain (primary 
production,  processing,  transport,  handling  and  distribution,  display  at final point 
of sale). The same applies to imported  foodstuffs. 

-10 

-  appropriate  measures are taken to  ensure the correct  information  of the  consumer 

about the nature and content of  foodstuffs 

- 

the  responsibilities  of  the  various  controlling  agents  (eg  producers,  Member 
States'  authorities, Commission services...) as well as the nature of the control (eg 
on-site inspection, audit of control systems...) are clearly  defined. 

In this context,  account  must be taken  of the fact  that,  following  the  entry into  force 
of  the  Maastricht  Treaty,  the  Commission  has  acquired  new  responsibilities  to 
contribute to  the  attainment  of a high level  of human  health  protection  (Article  129) 
of protection  of consumers  (Article  129a), and  of the  environment  (Article  13Or). In 
recent  years,  increasing  attention  has  been  given  to  issues  such  as  nutrition  and 
health.The revision  of Article  129 of the  Treaty  is currently  under  discussion  by  the 
Inter-Governmental  Conference. 

Moreover,  in  recent  years,  increasing  attention  has  been  given  to  issues  such  as 
nutrition  and  health, which raises questions  as to  the  role  of the  Community  in  such 
areas. 

11 -

SIMPLIFICATION AND RATIONALISATION  OF COMMUNITY  FOOD LAW 

PART  n 

1. 

Introductory  remarks 

In  recent  years,  a  number  of  criticisms  have  been  expressed  concerning  the 
complexity,  fragmentation  and  incoherence  of  Community  food  law,  and  of  the 
difficulties  of  adapting  the  legislation  to  innovation.  In  particular  it  has  been 
suggested  that: 

certain  provisions  are  unnecessarily  detailed  or  prescriptive,  and  fail  to  take 
account of the development of internal control systems by industry to ensure the 
quality and safety  of food  products; 

there  are  instances  of  the  duplication  of  legislative  provisions,  or  of 
incoherences  between  different  vertical  rules  applicable  to  specific  sectors,  or 
between vertical and horizontal rules; 

the  complexity  of  the  legislation  and  the  slowness  of  Community  legislative 
procedures  makes  it  difficult  to  update  the  legislation  to  take  account  of 
technical and scientific  progress. 

At the political  level, the Internal  Market  Council  has  also  called  on the  Commission 
to consider the scope for the simplification  of internal market  legislation. 

The objective  of this Part is to consider the general approach  of the Community to the 
foodstuffs  sector,  in  the  light  of  these  criticisms,  and  to  consider  the  scope  for 
measures to simplify  and rationalise Community food  law. 

2.  General  considerations 

One of the essential responsibilities  of the public authorities has been to ensure that  an 
adequate  supply  of  safe  and  wholesome  food  is  available  to  consumers.  Today,  all 
developed  countries  have  adopted  a  substantial  body  of  legislation  which  seeks  to 
guarantee  that  food  is  safe,  wholesome  and  fit  for  human  consumption,  that 
commercial  transactions  are  conducted  fairly,  and  that  the  necessary  systems  of 
official  control  and inspection are put in place. 

In recent years,  a new range  of issues concerning  foodstuffs  has  emerged,  as a result 
of  increasing  scientific  knowledge  and  popular  awareness  of  the  links  between 
nutrition  and health,  and also as a result of the new aspirations  of consumers  who  are 
not  only  interested  in  "safe  food"  but  are  also  increasingly  concerned  about  the 
methods used  in agricultural  and food  production. 

-12 

As  work  towards  the  implementation  of  the  internal  market  and  the  common 
agricultural  policy  has  progressed,  national  rules  have  increasingly  been  replaced  by 
Community legislation.  Today, the vast  majority  of food  law has been harmonised  at 
Community level, and in many fields the scope for unilateral initiatives by the Member 
States  is  severely  restricted.  It  follows  that  the  Community  must  itself  develop 
policies which provide for  a high level of protection  and meet the legitimate  demands 
and  expectations  of  consumers,  but  avoid  legislation  which  imposes  unnecessary 
burdens  on  producers  and  industry,  the  costs  of  which,  of  course,  are  ultimately 
passed on to consumers through higher prices. 

As noted  above, since  1985, the scope of Community food  legislation has, in general, 
been limited  to  measures which  are necessary  for  the  protection  of public health,  for 
the protection  of other  consumer interests,  and for  the establishment  of the necessary 
control provisions. Moreover,  the fact  that  Community  legislation  has resulted  in the 
replacement  of  15 different  and sometimes conflicting  sets of rules with a single set of 
harmonized  rules has of itself made a significant  contribution  to  the  simplification  of 
food  law. 

Against  this general background  it  should  be clearly understood  that  there  can be no 
question  of  wholesale  deregulation  and  the  dismantling  of  the  system  of  protection 
which has been put in place. The objective is to provide a body of legislation which is 
effective,  straightforward,  simpler  to  understand,  and  more  user  friendly  for  those 
principally  concerned,  producers,  industry,  food  businesses,  enforcement  authorities 
and consumers. 

General  regulatory  approach 

Food  law  is  a  matter  of  great  public  concern.  Only  a  high  level  of  security  and 
effective  public control  can minimise the vulnerability  of food  to  health  scares  which 
can have a major  impact  on  consumer  demand,  industry  profits  and  employment.  An 
effective  legislative  and  regulatory  framework  is  therefore  essential.  Moreover,  in 
view of the increasing  complexity  of food  production  and  distribution,  it  is necessary 
to ensure that the entire food  chain is covered.  There is no point in strictly  controlling 
parts of the food  chain if contamination can be introduced  at other points. 

Nevertheless this regulatory  framework  must be  designed  and  implemented  in'such a 
way  as  to  take  full  account  of  the  fact  that  the  primary  responsibility  for  the 

13 

production  of  safe  and  wholesome  food  lies  with  producers  and  industry.  Thus, 
whenever  possible,  it  should  offer  industry  the flexibility to  design  and  implement 
appropriate internal monitoring procedures, provided these are backed up by  effective 
official  control systems. 

In  some  instances,  specific  detailed  legislation  may be  necessary.  This  is  particularly 
important  in cases where treatments  which  are  difficult  to  detect  could  otherwise  be 
used to conceal the effects  of unhygienic or unsound production methods. 

In  other  cases,  it  is  sufficient  that  regulatory  requirements  are  worded  in  terms  of 
their goals and intended result, rather than in terms of prescribing how that result is to 
be  achieved.  Once  a clear  legislative framework has been  established  setting  out  the 
goals  to  be  achieved,  economic  operators  can  be  left  to  implement  the  legislation, 
subject  to  the  effective  supervision  of  the  control  authorities,  using  HACCP-type 
systems, codes of practice and other appropriate instruments. 

The  difference  between  the two  approaches  is most  clearly  illustrated  in the field of 
food  hygiene,  where  they  co-exist.  For  food  products  of  animal  origin,  which  are 
sensitive  from  the  health  point  of  view,  a  series  of  detailed  vertical  directives 
prescribe  in  some  detail  the  hygiene  requirements  which  must  be  observed.  Other 
foodstuffs  are covered  by the general directive on food  hygiene. Although  it  contains 
some  prescriptive  provisions,  this  latter  directive  aims  at  a  more  general  approach, 
defining  the  objectives  of  food  hygiene  and  leaving  a large  measure  of flexibility for 
industry in its implementation.  The area of food  hygiene is considered  in greater detail 
in Part III,  Section 6. 

Both  approaches  offer  advantages  and  disadvantages.  Since  the  more  prescriptive 
approach  requires  the  legislator  to  identify  the  major  risk  factors  and  the  means  of 
managing  those  risks,  it  often  makes  it  easier  for  companies  to  identify  their 
obligations  and  it  facilitates  the  tasks  of  the  control  authorities.  The  more  general 
approach,  on  the  other  hand,  leaves  industry  with  greater  flexibility 
in  the 
implementation  of the legislation,  and is thus likely to  reduce compliance  costs, but it 
must  ensure  a  level  of  protection  of  public  health  which  is  equivalent  to  the  more 
prescriptive approach. It is also likely to reduce the need for frequent updating  of the 
legislation.  However,  it  requires  both  food  businesses  and  the  control  authorities  to 
take a much more active role in analysing the hazards presented  by different  activities 
and  ensuring that  effective  measures may be taken to  control them.  This may  present 
particular  difficulties  for  small  businesses  working  in  the  sector,  although  the 
elaboration  of industry wide codes of practice may provide a solution to this problem. 

14-

It  should  be  noted  that  the  two  approaches  are  not  necessarily  mutually  exclusive. 
Community legislation on food  additives provides an example of a field in which they 
have  been  successfully  combined.  The  legislation  is  based  upon  a  rigorous  safety 
evaluation  of all additives. Only those additives which have been found  to be safe  for 
use in food  may be used within the Community. Where the  safety  evaluation  has led 
to the conclusion that  it is necessary to  establish  a total  acceptable  daily intake  (adi) 
for  the  protection  of  public  health,  prescriptive  limits  are  set  for  the  use  of  each 
additive in each food in order to ensure that human exposure does not exceed the adi. 
However,  where  the  safety  evaluation  leads  to  the  conclusion  that  an  adi  is  not 
necessary,  the concept  of  "quantum satis" is applied.  This means that  industry  is  free 
to use the additive in question, in accordance with good  manufacturing  practice,  at a 
level no  higher  than is necessary  to  achieve the intended  purpose,  and  provided  that 
the consumer is not misled. 

In  these  circumstances,  the  Commission  considers  that  a  balanced  approach  is 
necessary  between  detailed  prescriptive  legislation,  and  a  more  general  legislative 
approach.  It would  invite comments  on whether that  balance is correctly  reflected  in 
current Community legislation. 

4.  Role of self regulation  in the foodstuffs  sector 

Because of the sensitivity of the foodstuffs  sector, there has always been some debate 
as  to  the  extent  to  which  the  use  of  self-regulatory  instruments,  such  as  codes  of 
practice  or  standards,  is  appropriate  either  as  an  alternative  to  regulation  or  to 
supplement it. 

Where  voluntary  instruments  are used,  it  is important  that  these  instruments  remain 
genuinely  voluntary  and  that  appropriate  safeguards  are  applied  in  order  to  ensure 
that the procedures for their elaboration  are transparent,  open to  all interested  parties 
and provide for the necessary quality control of the work. 

Hitherto,  the  use  of voluntary  instruments  as  an alternative  to  regulation  has  mainly 
taken place: 

in  the  field  of  compositional  specifications  for  foodstuffs. 
In  its  1985 
Communication  on  the  realisation  of  the  internal  market  for  the  foodstuffs 
sector,  the  Commission  announced  that  it  would  no  longer  bring  forward 
legislative  proposals  to  harmonize  compositional  specifications  for  foodstuffs, 
except  where  necessary  for  the  purposes  of  the  Common  Agricultural  Policy, 
and  would  encourage  instead  the use  of voluntary  standards  in this field. Since 
then,  the  experience  of  standardization  in  this  field  at  European  level  has  not 
been  particularly  successful,  and  virtually  no  European  standards  have  been 
adopted  concerning  quality  specifications  for  foodstuffs,  despite  several 
attempts.  However,  at  the  national, level,  there  has  been  an  increasing  use  of 
standards,  or  equivalent  instruments  such  as  codes  of  practice,  which  brings 
with it the risk of new de facto  barriers to intra Community trade. 

- 1 5-

in  the  field  of  methods  of  sampling  and  analysis,  where  the  experience  at 
Community level has been much more positive, and  a number  of standards have 
been adopted. 

In the field of food  hygiene, voluntary instruments  are being used  to  compliment  the 
existing legislation. Article 5 of Directive 93/43/EEC  encourages the  development  of 
codes of good  hygiene practices which food  businesses  can use  on  a voluntary basis, 
and which can  serve as guidelines for  the implementation  of the general principles  of 
food  hygiene  laid  down  in  the  Directive.  In  addition,  the  Directive  sets  out  a 
procedure  for  the recognition  of the guides at Community  level,  and  sets  out  certain 
guarantees to ensure that they are developed by representatives of the food  businesses 
involved,  and of other groups which are substantially  affected,  such as the  competent 
authorities and consumer groups, that they meet the hygiene requirements laid  down, 
that  they  are  practicable,  and  that  there  is  adequate  consultation  during  their 
preparation.  In addition to a number of initiatives at national level, the  Commission is 
aware that  a number of such guides are in preparation  at the European  level,  notably 
in the fields of edible ices, patisserie and the sale of hot  and  cold  foods  and  drinks by 
vending machines. 

The  Commission  would  welcome  comments  on the  role  of voluntary  instruments  in 
the foodstuffs  sector. It would also welcome comments on the possibility of widening 
the scope of application of existing national voluntary instruments  to  cover the whole 
Community. 

5.  Horizontal  or vertical  approaches  to food  law 

Because  of the  great  diversity  of the  foodstuffs  sector,  it  is  sometimes  necessary  to 
consider  whether  preference  should  be  given  to  a  horizontal  approach,  which  lays 
down general rules applicable to foodstuffs  in general, or whether  a vertical  approach 
laying down specific rules for a particular sector should not  sometimes be used. 

Within  the  framework  of  the  legislation  adopted  under  the  1985  White  Paper 
Programme  for  processed  foodstuffs,  priority has in general been given to  horizontal 
measures  which  apply  to  all  categories  of  foodstuffs  (additives,  flavours,  extraction 
solvents,  labelling,  nutritional  labelling,  hygiene  etc).  Nevertheless,  recourse  to 
vertical  measures  has  sometimes  been  considered  necessary,  notably  in  the  case  of 
foodstuffs  for particular nutritional purposes, and quick frozen  foodstuffs. 

In the case of the rules governing primary production  and products  of animal origin, a 
more  sectorally  based  approach  has  generally  been  used,  although  some  general 
legislation has also been adopted,  notably that dealing with  designations  of origin and 
specificities,  and the use of the organic label. 

- 1 6-

Specific  questions  concerning  the  co-existence  of  horizontal  and  vertical  texts  in 
existing Community legislation are dealt with in Part III. In general terms, however, it 
may be noted that rather than favouring  one approach  over the other in every case, it 
is a question of finding the appropriate balance between  the two  approaches,  both  of 
which  have  their  advantages  and  disadvantages.  The  horizontal  approach  makes  it 
possible  to  take  a  general  overview  of  a  particular  situation,  and  facilitates 
implementation,  particularly  for  food  businesses  working  in  many  sectors,  including 
not  only  manufacturers,  but  also  for  commerce  and  distribution.  The  vertical 
approach,  on the other hand makes it possible to adjust  the legislation to the needs of 
a  specific  sector,  particularly  in cases where  a more  targeted  approach  to  legislation 
has  been judged  necessary.  It  also  makes  it  possible  to  envisage  a  more  integrated 
regulatory approach which covers all aspects of a particular  sector. 

The Commission would particularly welcome comments on this issue. 

6. 

Subsidiarity  and  legislative  simplification 

Article 3b of the EC  Treaty  states that  in areas which do  not  fall  within  its  exclusive 
competence,  the  Community  shall  take  action,  in  accordance  with  the  principle  of 
subsidiarity,  only  if and  in  so  far  as the  objectives  of  the  proposed  action  cannot  be 
sufficiently  achieved  by the Member  States  and  can therefore,  by reason  of the  scale 
or effects  of the proposed  action, be better achieved by the Community. 

level 

For several years, it has been the practice of the Commission to include a 'Subsidiarity 
statement'  in  all new  legislative  proposals,  to  explain why  the  Commission  considers 
that  action  at  Community 
includes 
consideration  of the objectives  of the measure proposed  and whether  recourse to  less 
binding provisions would be sufficient  to achieve the objectives proposed.  In addition, 
on  16 January  1996, the Commission  adopted  general guidelines  on regulatory  policy 
which  are  intended  to  promote  the  coherence  of  Commission  activity,  to  rationalise 
and  modernise the evaluation  of the effects  of its proposals,  and to  reinforce  external 
consultations. 

is  necessary.  This  statement  also 

In  response  to  the  conclusions  of  the  Edinburgh  Summit  of  December  1992,  the 
Commission  has  undertaken  several  initiatives  to  simplify  existing  Community 
legislation  in  the  foodstuffs  sector.  These  initiatives  include  a  reconsideration  of 
whether  certain  items  of  legislation  are  necessary,  and  the  removal  of  unnecessarily 
restrictive provisions from  existing legislation. 

In April  1994 the  Commission  presented  a proposal  to  amend Directive  89/398/EEC 
on  foodstuffs  for  particular  nutritional  purposes  in  order  to  reduce  the  number  of 
specific  directives for  particular categories of dietetic foods  from  8 to 4. In effect,  the 

17 

Commission proposed  not to proceed with detailed  directives concerning low  sodium 
foods,  gluten  free  foods,  foods  for  diabetics  and  foods  for  athletes.  While  there  is 
general  agreement  that  there  is  no  need  for  detailed  directives  on  low  sodium  and 
gluten-free  foods,  and that  general  labelling  provisions would  suffice,  there  has been 
much  controversy  about the  need  for  directives  on  foods  for  diabetics  and  foods  for 
athletes.  The  Commission  amended  its  proposal  to  accept  an  amendment  from 
Parliament  calling  for  a  Directive  on  foods  for  diabetics.  However,  within  the 
Council,  a  substantial  majority  of  Member  States  contest  the  need  for  such  a 
Directive,  whilst  a  significant  number  of  Member  States  insist  on  the  need  for  a 
Directive on foods for athletes. 

In  addition,  on  17 April  1996, the Commission  adopted  a package  of 7 proposals  to 
simplify the old compositional  directives which were adopted  in the  1970s concerning 
honey,  sugars,  preserved  milks,  coffee  extracts, fruit juices  and  nectars, jams, jellies 
and  marmalades  and  chocolate  and  chocolate products.  Once again,  this exercise has 
given rise to  much controversy,  notably in respect  of the  compositional  rules  relating 
to  chocolate. 

These two examples clearly show that legislative simplification  is by no means an easy 
task.  Provisions  which  are  considered  as  unnecessarily  restrictive  by  some,  may  be 
considered  fundamentally  importantly others. The potential  advantages  of legislative 
simplification  must  be  carefully  balanced  against  the  risks  of  reopening  old 
controversies,  and  of  the  possibility  of  creating  a  long  period  of  uncertainty  for 
economic operators in the sectors concerned. 

The  Commission  has  presented  proposals  to  consolidate,  simplify  and  update  the 
drinking  water  directive  (COM  (94)  612).  A  further  Commission  initiative  for 
legislative  simplification  in  the  field  of  veterinary  hygiene  is  examined  in  Part  III, 
Section 6. 

One particular  problem  in the food  sector  is the  difficulty  of reconciling the  practical 
concepts  of  simplification  and  subsidiarity  with  the  maintenance  of  a  high  level  of 
protection,  as  well  as  with  the  effective  operation  of  the  internal  market  and  the 
common  agricultural  policy.  Each year,  Member  States take  a number  of  legislative 
measures for  reasons of protection  of public health or for  consumer protection.  Such 
measures  can  create  barriers  within  the  internal  market  or  problems  for  the 
functioning  of the CAP, leading to calls for Community legislation.  However,  what is 
considered  as  necessary  by  one Member  State  may be  considered  as  over-regulation 
by others. Nevertheless,  if they  are to be fully  effective,  the  principles  of  subsidiarity 
and  legislative  simplification  must  be  applied  at  national  as  well  as  at  Community 
level. 

- 1 8-

In conclusion, it is important to emphasise the need to  ensure that the right balance is 
found between the application  of the principles  of  subsidiarity  and  simplification,  on 
the one hand, and the needs of the internal market on the other. In order to  ensure a 
high level of protection of public health and of consumers, the foodstuffs  sector is and 
will  continue  to  be  highly  regulated.  In  the  absence  of  Community  legislation, 
Member  States  will  continue  to  adopt  new  legislation  which  they  consider  to  be 
necessary  tc  protect  health  or  consumers.  Unless  an  appropriate  response  can  be 
found  at  Community  level,  there  will  be  a  constant  risk  of  fragmentation  of  the 
internal market back into national markets. 

7.  National legislative  initiatives 

Although  the  volume  of  Community  legislation  relating  to  the  foodstuffs  sector  has 
slowed  substantially,  the  flow  of  new  national  legislation  shows  no  sign  of  abating. 
Each  year,  the  services  of  the  Commission  consider  some  60-80  new  national 
legislative initiatives relating to  the foodstuffs  sector  under  the procedures  laid  down 
in Directive 83/189/EEC. 

In  accordance  with  the  procedure,  Member  States  are  required  to  notify  draft 
technical  legislation  to  the  Commission  which  circulates  the  draft  to  the  other 
Member  States.  A  standstill  requirement  of  3  months  initially  applies.  If  the 
Commission,  or  a  Member  State,  considers  that  the  new  measures  will  give  rise  to 
barriers  to  trade  within  the  internal  market,  it  may  issue  a  detailed  opinion,  as  a 
consequence of which a Member  State must postpone the application  of its  measures 
for  six months. In this case, the Member  State must  report  on the  action  it  proposes 
to  take  in  response  to  the  detailed  opinion.  The  procedure  also  enables  the 
Commission to defer the adoption of the national measure for up to  one year to  allow 
time for the preparation of proposals for legislation at the Community level, or for  the 
adoption  of  pending  proposals.  In the  CIA  Security  International  case,  the  Court  of 
Justice has recently held that the failure of a Member state to notify  draft  legislation in 
accordance  with  Directive  83/189/EEC  will  result 
legislation  being 
unenforceable  against individuals. 

that 

in 

The procedure  under  Directive  83/189/EEC  enables the Commission  to  comment  on 
draft  legislation,  and  to  ask  Member  States  to  make  changes  which  would  minimise 
the  effect  on  intra-Community  trade.  In  a  number  of  cases,  the  Commission  has 
successfully  persuaded  a Member  State  to  modify  the  draft  in  order  to  bring  it  into 
conformity  with  Community  law,  for  example  by  the  insertion  of 
a  mutual 
recognition  clause  into  the  national  legislation.  The  application  of  this  procedure  is 
also important  in that  it highlights  areas where further  Community  legislation  may be 
needed. 

However,  further  specific  notification  procedures  also  apply to  the  foodstuffs  sector. 
The Community  rules on food  labelling, on contaminants  and  on food  hygiene  permit 
a Member  State to  adopt  more  specific  rules than those  adopted  at  Community  level. 

- 1 9-

In  line  with  the  principle  of  subsidiarity,  Member  States  can  therefore  adopt  more 
detailed  legislation  to  take  account  of  the  particular  situation  in  their  country. 
However,  in order  to  protect  the  Community  interest,  and  notably  the  operation  of 
the  internal  market,  the  Commission  is  given  powers  to  supervise  the  use  which 
Member  States  make  of this  possibility.  Thus Member  States  are  required  to  notify 
the texts to the Commission,  and allow the Commission three months to  examine the 
draft.  If the Commission has doubts about the effect  of the legislation  on the  internal 
market,  the  Commission  may  issue  a  negative  opinion.  Subject  to  a  favourable 
opinion from the Member  States within  the  Standing  Committee  for  Foodstuffs,  the 
Commission  may then require  a Member  State to  amend  or withdraw  the  text,  or  to 
postpone its adoption for  a period, which may exceed  one year, in order to  allow the 
preparation of Community legislation. 

In  order  to  simplify  the  administrative  procedures  involved  in  notification,  the 
Commission  has  introduced  arrangements  whereby  all  notifications  are  submitted 
initially  to  a  single  entry  point.  However,  the  later  stages  of  the  procedure  differ 
considerably.  Under Directive  83/189/EEC,  if a Member  State  insists  on  maintaining 
its  draft  legislation,  claiming  it  is justified  under  Article  36  of  the  Treaty,  it  may 
proceed  to  the  adoption  of  the  national  text  once  the  relevant  standstill  period  has 
expired.  In this case, the Commission must  decide whether  or  not  to  refer  the  matter 
to  the  Court  of  Justice  for  a  definitive  ruling  on  whether  the  national  measure  is 
compatible  with  Community  law.  Under  the  specific  procedures  applicable  to 
foodstuffs,  the  Commission  has the possibility,  subject  to  a Committee  procedure,  to 
require  a  Member  State  to  amend  or  discontinue  legislation  which  is  considered 
unnecessary or disproportionate. 

The  Commission  considers  that  in  the  interests  of  administrative  efficiency,  it  is 
important  to  maintain  the  principle  of  one* entry  point  for  all  notifications.  On  the 
other  hand,  during  the  later  stages  of  the  procedure,  the  extension  of  the  powers 
which  are  provided  by  the  labelling,  contaminants  and  hygiene  rules  to  cover  the 
entire foodstuffs  sector may provide a means for  resolving the problem  of reconciling 
the  principles  of  subsidiarity  and  simplification  with  the  operation  of  the  internal 
market.  In  particular,  it  would  enable  the  Commission,  working  closely  with  the 
Member  States,  to  develop  clear  principles  for  the  treatment  of  new  national 
legislative  initiatives,  for  defining  the conditions under which they would  be  regarded 
as  creating  difficulties  for  the  internal  market,  and  the  circumstances  under  which 
national initiatives would give rise to a need for new Community legislation. 

On  the  other  hand,  it  is  clear  that  the  development  of  such  procedures  must  not  be 
allowed  to  interfere  with  the  fulfilment  of the  Commission's  obligation  to  ensure  the 
proper  application  of  Articles  30-36  of  the  Treaty  by  Member  States.  The 
Commission would invite comments on this issue. 

2 0-

8.  Need for further Community legislation to complete the internal  market 

In  some  non-harmonized  areas,  the  Member  States  have  frequently  emphasised  the 
difficulty  of using mutual recognition  clauses to  resolve problems  of  free  circulation. 
In  areas  where  the  protection  of  public  health  is  involved,  Member  States  may 
consider  that  their  proposed  or  existing  national  legislation  is  justified  for  the 
protection  of  public  health  under  Article  36,  and  therefore  be  unwilling  to  apply 
mutual recognition. In such cases, the need for further  Community legislation must be 
considered  in  the  light  of  the  public  health  interests  concerned,  and  in  accordance 
with the principles described above. 

Following  an  analysis  of the  complaints  received  in  recent  years  relating  to  the  free 
movement  of  foodstuffs,  the  Commission  has  identified  three  areas  where  the 
principle  of  mutual  recognition  cannot  by  itself  solve  the  adverse  effects  on  the 
internal  market.  The  Commission  therefore  intends to  initiate technical  consultations 
as  soon  as possible  on the need  for,  and possible  scope  of,  Community  legislation  in 
respect  of  processing  aids,  the  addition  of  vitamins  and  minerals  to  foodstuffs  and 
dietary supplements. 

-21 

PART  m 

REVIEW OF EXISTING COMMUNITY  LEGISLATION 

1.  General  considerations 

The  objective  of  this  Part  is  to  review,  in  the  light  of  the  general  considerations 
described  in the previous  part,  various  measures which might  be taken  to  rationalise 
or  simplify  existing  Community  legislation.  It  begins with  a  consideration  of  certain 
aspects  of  the  Community's  working  procedures,  such  as  the  choice  of  legal 
instrument  and  the  possibility  to  update  the  legislation  in  the  light  of  technical  and 
scientific  progress.  It  also  considers  the  scope  for  improving  the  coherence  of  the 
legislation  through  the  introduction  of  common  terms  and  definitions.  It  concludes 
with  a review  of the three  main  areas  of  Community  food  law  (hygiene,  quality  and 
labelling)  which  have given rise to  criticism that  certain  provisions  are  unnecessarily 
detailed  or unnecessarily  restrictive,  or which give rise to  difficulties  arising  from  the 
co-existence  of  legislative  texts  of  a  horizontal  and  a  vertical  nature,  including 
possible  problems  of  coherence  between  those  texts.  However,  the  Commission 
would  also invite comments on any areas which are not specifically  mentioned here. 

2. 

Transparency  of Community  legislation 

Adequate  consultation  of  the  socio-economic  interests  affected  by  Community 
legislation  before  and  during  the  decision-making  process  is  the  foundation  of 
transparency.  In  order  to  be  effective,  consultation  should  not  be  limited  to  the 
technical  aspects  of a proposal,  but  should  also  enable the  social  partners  to  provide 
all  relevant  information  and  comment  regarding  the  legislative  approach  envisaged 
and the costs and benefits  of the proposed measure. 

The Advisory  Committee  on Foodstuffs  was  established  in  1975 by the  Commission 
in order to  provide  a framework  for  the representation  of the socio-economic  groups 
primarily  concerned  by  the  foodstuffs  sector,  agriculture,  commerce,  consumers, 
industry  and  workers.  It  may  give  its  opinion  on  any  question  relating  to  the 
harmonisation of legislation in the foodstuffs  sector. Analogous Committees have also 
been  established  in  the  veterinary  sector,  and  in  the  various  agricultural  product 
sectors.  Meetings  of  these  Committees  provide  a  valuable  opportunity  to  reconcile 
the various  positions  of the different  parties on draft  legislation. However,  if they  are 
to be effective  it is necessary that  documents  are circulated  in good  time before  each 
meeting  and  that  the  participants  are  able  to  consult  fully  with  the  various  interests 
which they  represent. 

- 2 2-

The services of the Commission are currently taking a number of steps to improve the 
consultation  of  the  socio-economic  partners  during  the  preparation  of  Community 
legislation,  including  publication  of  notices  of  intention  to  legislate  in  the  Official 
Journal,  increased  use  of  Green  Papers  and  other  consultation  documents  and 
increased contacts with interested parties. Nevertheless, difficulties  still arise when the 
other  institutions  propose  major  changes  to  Commission  proposals,  the  effects  of 
which are often  difficult  or impossible to evaluate within the limited time available. 

3.  Use of the regulation as an alternative to directives 

In  certain  cases,  the  Community  has  undertaken  the  approximation  of  national 
legislation  in  two  stages.  In  the  first  stage,  a  framework  text  sets  out  the  general 
criteria and principles applicable to the matter. In the second  stage, a series of  specific 
provisions  are  adopted  to  ensure  the  full  and  uniform  implementation  of  these 
principles throughout  the Community.  These implementing  provisions  are  sometimes 
extremely  detailed,  and  leave  little  or  no  margin  of  discretion  to  Member  States  in 
their implementation. Examples include the specific  Community  provisions  relating  to 
additives, materials in contact with foodstuffs  and extraction solvents. 

In  other  cases,  although  contained  in  a  single  text,  the  provisions  of  Directives  are 
also extremely detailed and leave little margin of discretion to Member States. 

In such circumstances, the use of the regulation  as an alternative to the directive may 
present several advantages: 

the  use  of  the  regulation  facilitates  the  uniform  application  of  the  legislation 
throughout  the internal  market; 

the use of  the regulation  increases the transparency  of  Community  law; 

since  national  implementing  legislation  is  not  necessary,  the  use  of  the 
regulation  facilitates  the  rapid  updating  of  Community  legislation  to  take 
account of  technical and  scientific  developments. 

For  these  reasons  it  is  suggested  that  consideration  be  given  to  greater  use  of 
Regulations  in  appropriate  cases,  both  in  primary  and  in  secondary  Community 
legislation.  However,  legislation  which  is  limited  in  scope  to  the  harmonisation  of 
general principles and criteria,  such as legislation  on the official  control  of  foodstuffs, 
would  continue to be adopted by means of a directive. 

23 

4.  Updating legislation  to take account of technical and scientific  progress 

The  ability  to  amend  legislation  rapidly  to  take  account  of  technical  and  scientific 
progress is of fundamental  importance. From the point of view of innovation,  and the 
competitiveness  of  European  industry,  it  is  important  that  innovatory  products  can 
gain rapid  access to  a continental-scale  market. From the public health point  of view, 
also, it is important  to be able to  adapt the legislation quickly to take  account  of new 
risk factors which may emerge. 

However,  experience  suggests that the  Community  does  not  possess  the  instruments 
which  are  necessary  to  respond  to  the  quickening  pace  of  innovation  and  the  ever-
increasing range of scientific  knowledge. 

One reason  for  this  is the unwillingness  of the  Council  and Parliament  to  delegate  to 
the Commission the necessary powers for the technical implementation  of Community 
legislation.  Although the Council and Parliament have delegated  significant  powers to 
the  Commission  in  fields  such  as  contaminants,  general  food  hygiene,  materials  in 
contact  with  foodstuffs,  foodstuffs  for  particular  nutritional  purposes  and  food 
labelling,  in  other  areas,  such  as  food  additives,  extraction  solvents  and  veterinary 
legislation, there has been much less delegation of competence to the Commission. 

For  example,  in  the  field  of  food  additives,  any  amendment  to  add  or  withdraw  an 
additive  from  the  positive  list,  or  to  enlarge  or  restrict  the  conditions  of  use  of  an 
additive,  must  be  adopted  using the  co-decision  procedure.  Once  allowance  is  made 
for  the time  necessary  for  an evaluation  of the public health  aspects  by the  Scientific 
Committee  for  Food,  the  preparation  of a Commission  proposal,  and  the  completion 
of two,  possibly  three  readings  by the  Council  and Parliament  under  the  co-decision 
procedure,  an  average  of  about  5  years  is  necessary  to  complete  the  procedure  at 
Community  level.  This  increases  to  6-7  years  if allowance  is  also  made  for  the  time 
necessary  for  the  adoption  of national implementation  measures.  In  contrast,  in most 
if  not  all  Member  States  a  similar  decision  would  be  taken  rapidly  by  a  ministerial 
decision,  on  advice  from  the  competent  national  scientific  advisory  committee,  and 
without the need for primary legislation. 

Even if powers are delegated to the Commission, they are often  subject  to  procedures 
which  are  inappropriately  burdensome.  For  example,  in  a  declaration  on  the  powers 
of  implementation  of  the  Commission  annexed  to  the  Single  European  Act,  the 
Intergovernmental  Conference  requested 
to  give  the  Advisory 
Committee  procedure  in particular  a predominant  place  in the  interests  of  speed  and 
in  the  decision-making  process,  for  the  exercise  of  the  powers  of 
efficiency 
implementation  conferred  on  the  Commission  within  the  field  of  Article  100a". 
However, 
rejected 
Commission  proposals  for  a  type  I  Consultative  Committee,  in  favour  of  a  type  III 
Regulatory  Committee,  which  requires  a  favourable  opinion  from  a  qualified 

the  Council  has  systematically 

the  foodstuffs 

'the  Council, 

sector, 

in 

- 2 4-

majority  of Member States before the Commission can take a decision. In the fields  of 
veterinary  hygiene,  the  Council  systematically  has  recourse  to  a type  Illb  procedure 
which enables a simple majority  of Member  States to block any action at  Community 
level. 

The Commission considers that the adaptation of Community legislation to innovation 
and  technical  progress  in  the  foodstuffs  sector  constitutes  a  serious  problem  which 
requires  careful  consideration.  Comments  received  from  interested  parties  on  this 
matter  will  be  considered  in  the  light  of  the  outcome  of  the  institutional  and 
intergovernmental  discussions in progress. 

5.  Rationalisation  of definitions  used  in Community  foodstuffs  legislation 

Existing  Community  foodstuffs  legislation  already  contains  a  series  of  definitions, 
including definitions  of food  additives, food flavourings, food  flavourings,  processing 
aids,  contaminants,  pesticide residues, residues of veterinary  medicines,  materials  and 
articles  intended  to  come  into  contact  with  foodstuffs,  labelling,  nutrition  labelling, 
nutrition claims, official  control of foodstuffs  and hygiene of  foodstuffs. 

Community  veterinary  legislation  also includes  definitions  of meat,  red  meat,  poultry 
meat,  rabbit  meat, farmed  game, wild game,  fishery  products,  bivalve molluscs,  milk, 
milk products,  egg products,  eggs,  snails, frogs  legs, other  products  of animal  origin 
and processed  products. 

In the past,  doubts  have  sometimes  arisen as to whether these  definitions,  apply  only 
to  those  specific  pieces  of  legislation  in  which  they  are  contained  or  whether  they 
apply  more  generally.  To  remove  any  further  doubt,  the  Commission  proposes  to 
stipulate that these definitions  are generally applicable to all Community legislation  on 
foodstuffs. 

5.1  Definition  of  "foodstuffs" 

Although the legislation  of most Member  States contains a definition  of  "foodstuffs", 
the Community does not as yet have its own definition.  The European Parliament  has 
officially  asked  the  Commission  to  make  a  proposal  to  this  effect,  because  a 
Community  definition  would  ensure that  all Community  legislation  on foodstuffs  will 
actually apply to the same products and substances in all Member  States. 

The  following  definition,  based  on  that  contained  in  the  Codex  Alimentarius,  is 
suggested  for  consideration: 

"Foodstuff  means  any  substance  or  product,  whether  processed,  partially 
processed  or  unprocessed,  intended  to  be  ingested  by  humans,  with  the 
exception  of  tobacco as  defined  by Directive  89/662/EEC,  medicinal  products 
as  defined  by Directive  65/65/EEC,  and  narcotic  or psychotropic  substances 
controlled  by  Member  States  pursuant 
international 
conventions. 

the  relevant 

to 

25 

This  definition  is  deliberately  wide  in  scope  and  is  intended  to  cover  all  products 
intended  for  direct  human  consumption,  including  drinks  and  chewing  gum,  and  all 
substances  used  in  the  manufacture,  preparation  and  processing  of  foods,  including 
raw materials, ingredients, contaminants and residues in the broadest sense. 

The  concept  of  ingestion  is  intended  to  cover  all  products  which  pass  through  the 
gastrointestinal  tract,  including  products  taken by mouth  or  nose  or  administered  by 
gastric  intubation.  On  the  other  hand,  the  definition  would  not  cover  products 
administered  parenterally directly into the blood  stream. 

A  further  question  concerns  the  application  of  the  definition  to  primary  production 
which  may  be  intended  either  for  human  consumption  or  for  industrial  use  (e.g. 
potatoes  which  may  either  be  consumed  as  food  or  used  for  the  production  of 
industrial  starch,  or  chemicals  which  may  be  used  as  food  additives  or  for  other 
industrial  purposes.)  Their  inclusion  within  the  scope  of  the  definition  would  mean 
that  producers  would  have  to  fulfil  all  the  relevant  obligations. arising  under 
Community  food  legislation,  which may be inappropriately  restrictive. However,  it is 
obviously  necessary to  ensure that  all substances used  in food  meet  the  requirements 
of Community legislation. The Commission would invite comments on this question. 

5.2  Definition  of "placing on the market" 

The  concept  of  "placing  on  the  market"  is  used  several  times  in  Community  food 
legislation,  without  being  defined.  A  definition  of  marketing  is  included  in  the 
veterinary  hygiene  directives,  but  this  is  not  entirely  suitable  for  the  purposes  of 
foodstuffs  legislation  because  it  excludes  retail  sale.  Other  definitions  of  placing  on 
the market  are included  in the new approach  directives  and Directive  90/220/EEC  on 
the  deliberate  release  of  genetically  modified  organisms  into  the  environment,  but 
these also are not entirely appropriate to the foodstuffs  sector. 

One possible definition would be: 

"placing  on  the  market"  means  any  operation  the  purpose  of  which  is  to 
supply foodstuffs  to a  third party,  including  supply for  sale  or any  other  form 
of transfer against payment  or free  of charge to a third party  and storage  with 
a  view to supply to a third party,  with the exception of supply for  the  purposes 
of scientific  research conducted under the supervision of the Member  States. " 

To  ensure  full  compliance  with  Community  regulations  on  health  protection,  the 
proposed  definition  covers  not  only  commercial  transactions  but  also  charitable 

26 

operations  and  the  provision  of  free  samples.  The  definition  would  also  apply  to  all 
types of supply of foodstuffs,  including supply by restaurants,  canteens, hospitals  and 
the armed  forces.  However  term  "third  party"  has been used  deliberately  in order  to 
exclude  storage  or  the  transfer  of  foodstuffs  to  family  or  friends  within  the  family 
home. 

6. 

Food  hygiene 

The field of food  hygiene would  appear to  raise some of the most  difficult  questions 
for the simplification  and rationalisation of Community food  legislation. 

For  foodstuffs  of  animal  origin,  a  series  of  11 vertical  directives  establish  specific 
conditions  of hygiene for  the  categories  of foodstuffs  concerned:  fresh  meat,  poultry 
meat;  meat  products,  minced  meat  and  meat  preparations;  rabbit;  farmed  and  wild 
game;  fish;  shellfish;  eggs  and  egg  products;  milk  and  milk  products;  and  other 
products  such  as  frogs  legs,  snails  and  honey.  Further  legislation  covers  the 
importation  and  control  of  foodstuffs  from  third  countries.  These  directives  set  out 
specific  regulatory  requirements  for  those  aspects  of  the  products  concerned  which 
are considered  particularly  sensitive, while using  a HACCP  based  approach  for  other 
aspects. 

For  foodstuffs  which  are  not  covered  by  these  specific  provisions,  the  general 
Directive  on the  hygiene  of foodstuffs  applies  (Directive  93/43/EEC).  This  Directive 
applies a more generalized  approach to hazard  management,  based  on the  application 
of  HACCP  principles  and  the  development  of  voluntary  codes  of  good  hygiene 
practice. 

The  co-existence  of  these  different  texts  has  resulted  in  numerous  criticisms  of 
inconsistency  and  incoherence.  Thus  Article  1 (2)  of  the  general  hygiene  directive 
requires  the  Commission  to  establish  the  relationship  between  the  specific  hygiene 
rules and those of the general directive and, if necessary, make proposals. 

As a first step in this process, the Commission has launched  a large scale  consultation 
exercise  on the inter-relationship  between  the vertical veterinary  hygiene  rules  which 
apply to foodstuffs  of animal origin. To this end, the services of the Commission have 
prepared  a  Guide  to  certain  rules  governing  the  production,  marketing  and 
importation  of products of animal origin intended  for  human consumption.  The guide 
envisages  the  consolidation  of  the  provisions  of  14  separate  directives  relating  to 
animal and  public health  into  a single text  which would  also  covers the  conditions  of 
imports  from  third  countries.  Certain  common  principles,  such  as HACCP  would  be 
extended  to  cover  all the Directives, and certain unnecessarily  detailed  provisions  and 
contradictions in the texts would be eliminated. 

2 7-

At  the  same  time  the  Commission  has  launched  a  consultation  exercise  on  the 
possibilities  for  simplification  of the  rules.  In  particular,  the  Commission  specifically 
invited comments from interested parties on the following  points; 

the  role  of  voluntary  instruments  such  as  standards  or  codes  of  practice  in 
veterinary hygiene; 
temperature control requirements; 
the  need  and  appropriateness  of  derogations  for  small  and  medium-sized 
enterprises; 
the international dimension of veterinary hygiene rules; 
the role of self-control by manufacturers  and the role of the public authorities; 
authorization procedures and procedures for the approval of establishments; 
conformity  marking. 

Further questions have also been raised concerning the inclusion in hygiene legislation 
of quality or labelling provisions which are not directly related to food  hygiene. 

Once  the  relationship  between  the  specific  vertical  hygiene  directives  has  been 
clarified,  consideration  must  be  given  to  the  relationship  between  them  and  the 
general directive on food  hygiene. In this context, it would  appear appropriate to give 
priority to ensuring  that there is a coherent  and consistent body of legislation  relating 
to  food  hygiene.  This  can  best  be  achieved  by the  application  of HACCP  principles 
and  limiting  detailed  prescriptive  provisions  to  cases  where  they  are  considered 
essential. 

Nevertheless,  it  should be noted that there is scope for  some flexibility in the  manner 
in  which  HACCP  principles  are  conceived  and  applied.  According  to  the  Codex 
Alimentarius  Guidelines  for  the  Application  of  the  Hazard  Analysis  Critical  Control 
Point  System, HACCP  is a system which  identifies  specific  hazards  and  preventative 
measures for their control. The system consists of seven principles. 

1. 

Identify  the potential hazards associated with food  production at all stages,  from 
growth,  processing,  manufacture  and  distribution,  until 
the  point  of 
consumption.  Assess  the  likelihood  of  occurrence  of  the  hazards  and  identify 
preventative measures for their control.  ' 

2.  Determine  the  points/procedures/operational  steps  that  can  be  controlled  to 
eliminate the hazards or minimize their likelihood  of occurrence (Critical  control 
point (CCP). 

3. 

4. 

Establish critical limits which must be met to ensure the CCP is under control. 

Establish  a  system  to  monitor  control  of  the  CCP  by  scheduled  testing  or 
observations. 

28 

5. 

6. 

7. 

Establish  the  corrective  action  to  be  taken  when  monitoring  indicates  that  a 
particular CCP is not under control. 

Establish  procedures  for  verification  which  include  supplementary  tests  and 
procedures to confirm that the HACCP system is working  effectively. 

Establish  documentation  concerning  all  procedures  and  records  appropriate  to 
these principles and their application. 

In the general hygiene directive, the first five of these principles are implemented  into 
Community legislation. However,  it was not considered  necessary to lay down  formal 
requirements  regarding  verification  and  documentation.  Each  food  business  is  left 
with  the  flexibility  to  decide  what  requirements  are  necessary,  subject  to  the 
supervision  of the  competent  authority.  On the  other  hand,  because  of the  nature  of 
the foodstuffs  concerned,  the basic principles for  own checks set out in the veterinary 
hygiene directives  include  detailed  rules on keeping  a written  record  for  presentation 
to  the competent  authority.  This example illustrates the need  to  maintain  a degree  of 
flexibility  in the design  and  implementation  of food  hygiene regulations  to  ensure  the 
maintenance  of  a  high  level  of  protection,  whilst  keeping  the  regulatory  burden  for 
business to a minimum. The search for consistency and coherence  should not result in 
the imposition of a uniform  system where it is inappropriate. 

It  is  generally  recognised  that  in  order  to  be  effective,  any  system  of  food  hygiene 
legislation  must  cover  the  entire  food  chain, from primary  production  until  the  point 
of  consumption.  The  general  food  hygiene  directive  covers  all  stages  of  food 
production  and  distribution  after  primary  agricultural  production.  However,  there  is 
no  general  Community  legislation  covering  the  hygiene  of  products  of  non-animal 
origin  at  the  primary  agricultural  production  stage.  The  Commission  would  invite 
comments  on whether  the  existing  rules to  ensure  the  safety  and  hygiene  of  primary 
products  of  non-animal  origin,  such  as  the  rules  on  pesticide  residues,  and 
contaminants are  sufficient. 

In the case of foodstuffs  of animal origin, the primary production  stage is covered  by 
the  veterinary  hygiene  rules.  These  directives  cover  all  stages  from  primary 
production  to  distribution.  However,  retail  sale  is,  in  general,  excluded  from  the 
scope  of  the  veterinary  hygiene  rules,  and  the  general  hygiene  directive  therefore 
applies.  The  Commission  would  invite  comments  on  whether  the  retail  supply  of 
products  of  animal  origin  should  continue  to  be  covered  by the  general  directive,  or 
whether it should be brought within the scope of the veterinary hygiene directives. 

-29 

7. 

Food  quality 

In its  1985 communication  on the completion of the Internal Market  in the  foodstuffs 
sector, the Commission indicated that it would  no longer bring forward  proposals  for 
vertical  legislation  imposing  qualitative  specifications  for  particular  categories  of 
product. Instead,  the Commission indicated that it would  rely on the use  of labelling, 
together with the application of voluntary instruments, to provide the basis for  mutual 
recognition  of national rules in accordance with the principles laid down by the  Court 
of Justice. 

In  accordance  with this  approach,  the  question  of  quality  standards  and  certification 
within the internal market  (relating to products  or  companies)  is left  to the  voluntary 
initiative  of  operators.  Obviously,  however,  these  instruments  should  be  used  in 
compliance with the rules on misleading information  and should  not  create barriers  to 
trade.  Moreover,  to  ensure  that  these  instruments  are  reliable,  operators  should  be 
encouraged to adhere to the standards recognized  at international  and European level, 
in particular  the ISO 9000  and EN 29 000  series.  Subsequently,  the  Commission  has 
taken  a  series  of  general  initiatives  designed  to  encourage  the  development  of  a 
European quality policy. 

A  rather  different  approach  has  been  followed  in  the  agricultural  sector.  It  is  not 
possible, given the specific  objectives  of the CAP, to envisage removing  all possibility 
of laying down  qualitative  specifications  concerning  product  composition.  Within  the 
framework  of  the  common  organisations  of  the  market,  quality  specifications  are 
necessary  for  example  where  financial  support  is  provided  under  the  Community 
budget. 

Where quality promotion  and certification  policy is concerned,  specific  measures have 
been  introduced,  particularly  with  regard  to  rural  development.  These  instruments 
relate  to  organic  farming  products,  certificates  of  specific  character  relating  to 
traditional products and protected geographical indications. 

Generally,  the  Commission  does  not  consider  that  the  differences  of  approach 
followed  under  internal market  and  agricultural  legislation give rise to  inconsistencies 
or  distortions  of competition. Nevertheless,  in the context  of the  simplification  of the 
veterinary  hygiene  rules,  it  may be worth  reviewing  the  quality  provisions  contained 
in the  legislation.  In  principle  it would  appear  that  where they  are  necessary,  quality 
provisions  should have their place in specific  quality legislation,  and be removed  from 
veterinary  legislation,  unless  a  health  link  is  established.  The  Commission  would 
welcome comments on this point. 

30 

8. 

Food  labelling 

Council  Directive  79/112/EEC  on  the  labelling,  presentation  and  advertising  of 
foodstuffs  was explicitly designed  to  constitute  a single legislative framework for  the 
compulsory  rules  on  the  labelling  of  foodstuffs.  The  Directive  has  been  now  been 
amended  many  times.  The  most  recent  amendments,  adopted  by  the  European 
Parliament and the Council in  1996, introduce the principle of quantitative  declaration 
of  ingredients  (QUID)  and  makes  changes  to  the  rules  on  the  labelling  of  the  sales 
name of the product  to take  account  of recent  case law  of the  Court  of Justice.  The 
Commission  intends  to  present  a  proposal  for  the  formal  consolidation  of  the 
Directive as soon as possible. 

Directive  79/112/EEC  is  based  upon  the  principle  of  functional  labelling.  The 
objective  of the Directive is to  ensure that  consumers  are provided  with the  essential 
information  as  regards  the  composition  of  the  product,  its  manufacturer,  and  its 
methods  of  storage  and  preparation  which  are  necessary  to  ensure  consumer  safety 
and  fair  competition.  Producers  and  manufacturers  are  free  to  provide  whatever 
additional  information  they wish,  provided  that  this is accurate  and  does  not  mislead 
the consumer. 

In addition to the rules laid down in Directive 79/112/EEC, a number of vertical texts 
contain specific mandatory labelling provisions, such as the Community rules on wine, 
fresh fruit and vegetables, eggs, and the specific  directives on foodstuffs  for  particular 
nutritional  purposes.  The Commission would  invite comment  on whether  it would  be 
desirable  to  consolidate  these  separate  provisions  into  a  single  labelling  text,  or 
whether  in the  interests  of  flexibility,  it  is  preferable  that  these  requirements  should 
continue to be set out in specific texts. 

Recently,  some concern  has been  expressed  that  certain  aspects  of the  labelling  rules 
have become unnecessarily  detailed.  In particular,  there have been  occasions,  both at 
Community  and at  national level, where legislation  has required  information  which is 
already  included  on  the  label,  for  example  in  the  list  of  ingredients,  to  be  repeated 
more prominently  elsewhere  on the label. In the  Sauce Béarnaise  case,  however,  the 
Court  recognises that the inclusion  of information  in the list of ingredients  is in many 
instances sufficient  information  for the consumer. 

-31 

However,  concern  has  also  been  expressed  that  other  aspects  of  the  labelling  rules 
may  not  always  provide  sufficient  information  for  the  consumer.  For  example,  the 
Commission  has  recently  been  asked  to  consider  amending  the  labelling  rules  to 
provide  for  more  information  about  the  possible  presence  of  known  allergens  in 
foodstuffs,  even in cases where the allergens are present  at very low levels,  including 
trace levels. Likewise, criticism has also been expressed  of the current  rules regarding 
the labelling of compound ingredients of foodstuffs.  Under current legislation, it is not 
necessary to list the ingredients of a compound ingredient separately, if the  compound 
ingredient  makes up less than 25% of the finished product.  Thus,  for  example,  in the 
case  of  a tart  which  contains  less  than  25% of  pastry,  it  is  sufficient  to  include  the 
mention  "pastry"  on  the  list  of  ingredients,  and  it  is  not  necessary  to  list  all  the 
ingredients of the pastry separately. It has been suggested that this upper limit of 25% 
is too high, and should be reduced to, perhaps, 5%. 

In  addition  to  the  core  mandatory  labelling  requirements,  certain  Community 
legislation  has  been  adopted  to  govern  the  provision  of  additional  information  by 
producers or manufacturers  on a voluntary basis. For example, within the  Community 
nutritional  labelling  is  not  obligatory.  However,  if  manufacturers  wish  to  make 
nutritional claims or to provide nutritional information  they must  do  so in accordance 
with  a  standardised  format.  Similarly,  Council  Regulation  (EEC)  2092/91  sets  out 
rules governing the use of the organic label on vegetables and vegetable products, and 
the  Commission  has  recently  proposed  rules  for  the  use  of  the  organic  label  on 
products of animal origin. 

It  is  important  that  Community  labelling  legislation  should  strike  the  right  balance 
between  mandatory  core labelling requirements  and the use of voluntary  instruments. 
The  Commission  would  invite  comments  on  whether  the  legislation  does  strike  the 
correct balance. 

As  noted  above,  producers  or  manufacturers  are  currently  free  to  make  whatever 
statements or claims they like on the labelling of foodstuffs,  provided those claims are 
correct  and  not  misleading.  The  responsibility  for  verifying  such  claims  lies  with 
Member  States. In recent years the range of claims being made  on food  labels  and in 
the  advertising  of  foodstuffs  has  increased  dramatically.  Health  claims  present 
particular  difficulties  because  the  alleged  beneficial  effects  of  a  particular  foodstuff 
may  be  the  subject  of  scientific  discussion,  making  it  difficult  for  the  competent 

32 

authorities to verify  the claim made. The Commission is aware of certain cases where 
the  Member  States  have  adopted  different  positions  on  the  acceptability  of  certain 
claims,  leading  to  problems  for  the  free  movement  of  the  foodstuffs  concerned.  At 
one  stage,  the  Commission  had  envisaged  bringing  forward  specific  legislation  to 
cover  food  claims, by defining  the  circumstances  under  which  certain  claims may  be 
made.  However,  this  work  encountered  a  number  of  technical  difficulties,  and  has 
been  shelved,  at  least  for  the  time-being.  Instead  consideration  is  being  given  to 
reinforcing  the  provisions  of  the  misleading  advertising  directive.  The  Commission 
would  specifically  invite  comments  on  the  approach  which  should  be  followed  at 
Community level to the regulation of claims, including  not  only compositional  claims 
such  as  'light'  and  'low-fat',  but  also  health  and  similar  types  of  claims  which  are 
increasingly being made on so-called 'functional  foods'. 

In  addition,  during  1997  the  Commission  intends  to  undertake  a  review  of  the 
nutritional  labelling  directive,  in particular,  in  order  to  up-date  certain  provisions  of 
the  Directive  to  take  account  of  new  scientific  information.  In  this  context,  the 
Commission would  specifically  invite comments on whether nutrional labelling should 
be made  compulsory  and whether  the nutritional  information  required  is  sufficient  to 
guarantee proper information  for the consumer.  This will provide the occasion for  the 
Commission  to  consider  other  comments  relating  to 
that  Directive.  At  the 
international level, the relevant Codex Alimentarius standards are also under review. 

Finally,  the  regulation  on  novel  foods,  which  include  inter  alia  foods  containing 
GMOs or produced  from  GMOs has been  adopted  recently.  This regulation  contains 
labelling  requirements  on  the  presence  of  certain  materials  such  as  GMOs.  The 
Commission  attaches  great  importance  to  the  correct  implementation  of  these 
labelling rules. 

33 

PART  IV 

MAINTENANCE OF A HIGH LEVEL OF PROTECTION 

1.  General  considerations 

Article  100a  (3)  of  the  Treaty  requires  the  Commission,  in  its  internal  market 
proposals  concerning  health,  safety,  environmental  and  consumer  protection  to  take 
as  a  base  a  high  level  of  protection.  Article  129  of  the  Treaty  provides  that  health 
protection  requirements  shall  form  a  constituent  part  of  the  Community's  other 
policies.  Moreover,  Article  129a  requires  the  Community  to  contribute  to  the 
attainment  of  a  high  level  of  consumer  protection  through  the  internal  market 
measures adopted  pursuant to  Article  100a and by specific  action which  supplements 
and  supports  the  policies  of  the  Member  States  to  protect  the  health,  safety  and 
economic interests of consumers and to provide adequate information  to consumers. 

In his  speech  to  the European  Parliament  on  18 February  1997, the  President  of the 
Commission made a plea for the gradual establishment  of a proper  food  policy giving 
pride  of  place  to  consumer  protection  and  consumer  health.  In  this  spirit,  the  Union 
must provide itself with the necessary means of action, identifying  two imperatives: 

the  closer  involvement  of the  Parliament  in the  decision-making  process;  to  this 
end  the  Commission  will  make  more  use  of  Article  100a  for  proposals  in  the 
veterinary  and phytosanitary field having as their principal objective  the health  of 
the  consumer,  whilst  trying  to  persuade  the  Intergovernmental  Conference  to 
accept that all legislative decisions should be taken by co-decision: 

the  need  to  give  the  Community  true  powers  in  the  field  of  health.;  thus  the 
Commission  has  presented  a  concrete  proposal  to  the  IGC  for  a  substantially 
revised  Article  129, involving three major  improvements: 
-  an  improved  procedure  for  coordinating  the  policies  pursued  by  Member 

- 

States 
the  possibility,  where  necessary  for  harmonization  at  Community  level  in  the 
field of human health; 

-  co-decision on health matters. 

34 

So far as food  safety is concerned, there -can be no scope for  compromise. The Treaty 
requires the Commission to take as a base a high level  of protection in its  proposals 
and to ensure that public health requirements are fully integrated into its policies. This 
level of protection  must be kept under  constant  review,  and where necessary  it must 
be  adjusted  to  take  account  of  new  information,  or  of  a  re-evaluation  of  existing 
information.  The aim of this Part is to review how these objectives are integrated  into 
the Community's policies for the management  of the internal market and the  common 
agricultural policy, and to invite suggestions for possible improvements. 

2.  The role of scientific  advice in the preparation of food safety legislation. 

In  principle,  the  Commission  considers  that  the  prior  consultation  of  independent 
scientific  experts  is  the  best  means  of  guaranteeing  scientific  objectivity  and 
consistency of hazard analysis during the preparation of rules relating to public health. 
To be effective,  the process of risk assessment  must  cover the entire food  chain.  For 
example,  in  assessing  the  safety  of  a  chemical  found  in  food,  all  sources  of  human 
exposure to the chemical must be considered,  including its presence as a  contaminant 
in  food  or  drinking  water,  and  human  exposure  resulting  from  its  use  as  a  food 
additive, a pesticide or a veterinary medicine. A number of scientific  committees  have 
responsibilities  which  relate  to  the  foodstuffs  sector,  including  the  Scientific 
Committee  for  Food  (SCF),  the  Scientific  Veterinary  Committee,  the  Scientific 
Committee  for  Pesticides,  the  Scientific  Committee  for  Animal  Nutrition,  and  the 
Scientific  Committee  for  Toxicity  and  Eco-toxicity.  An  integrated  approach  to  risk 
assessment  may  require  consultation  of  several  of  these  Committees.  Each 
Committee's risk assessment  will include particular  features  not  covered  by the  other 
committees,  for  example  good  veterinary  or  agricultural  practices.  The  involvement 
of several  committees is therefore  necessary,  but  coordination  is essential  in order  to 
avoid repeated  evaluation of the same risk or unnecessary duplication of  effort. 

In addition, it should be noted that the Committee for  Veterinary Medicinal Products, 
which  is  attached  to  the  European  Medicines  Evaluation  Agency  in  London,  is 
responsible  for  the  evaluation  of  the  safety  of  residues  of  veterinary  medicines  in 
foodstuffs  of animal origin. 

A  number  of  existing  Community  legislative  texts  provide  for  the  compulsory 
consultation  of the  SCF before  the  adoption  of legislation  which  may  have  an  effect 
on  public  health,  for  example  in the  fields  of  additives,  contaminants,  food  hygiene, 
materials in contact and novel foods. 

3 5-

If the scientific  assessment  process is to be credible and command  public  confidence, 
sufficient  guarantees  must  be  provided  of  the  objectivity  and  independence  of  the 
scientific  advice  received.  With  this  objective  in  mind,  the  Commission  has 
developed  a  new  approach  on  the  scientific  advice  which  is  laid  down  in  the 
Communication  on  Consumer  Health  and  Food  safety  recently  presented  to  the 
Council  and European Parliament.  This new  approach  will reinforce  the three  main 
principles  of  scientific  excellence,  independence  and  transparency  of  the  Scientific 
Committees by: 

ensuring  that  the  scientific  qualification  and  competence  are  the  criteria  for 
selecting members  of the  scientific  Committees  and  that  the  selection  process  is 
transparent  vis  à  vis  the  European  Parliament,  Members  States,  economic 
operators and consumers. 

ensuring that members of the Scientific  Committees are free from interests which 
may  be  in  conflict  with  the  requirement 
In  this 
respect requirements and procedures for  declaration of interests will be extended. 

to  give  independent  advice. 

operating  an  overall  policy  of  transparency  in  the  whole  process  of  scientific 
advice.  In  particular  European  Institutions  and  national  authorities  as  well  as 
well all interested parties, including consumers, both individuals and associations, 
will  have  access  to  information  on  the  working  procedures  of  the  Committees 
and to their advice. 

Furthermore the regrouping  of all Scientific  Committees under the  same  Commission 
Directorate  General will ensure  a greater  synergy  and  a better  co-ordination  of their 
work. 

The Commission will also continue its efforts  to: 

consolidate  the  principle  of  obtaining  Community  scientific  advice  before 
drafting  Community  foodstuffs  provisions  that  could  affect  public  health 
(although  certain exceptions will be necessary,  in particular  in the case of urgent 
safeguard  measures). 

apply  a  single  procedure  to  assess  all  relevant  risks  (the  'one  door,  one  key" 
principle) 

36 

On  the  other  hand,  it  is  important  to  note  the  limits  of  the  role  of  the  scientific 
committees.  At  both  the  Community  level  and  the  global  level,  a  clear  distinction  is 
drawn between  the  concepts  of risk assessment  and  risk  management.  According  to 
definitions which are under consideration by Codex Alimentarius, risk assessment  is a 
scientifically  based  process  consisting  of  the  identification  and  characterization  of 
hazards,  the  assessment  of  exposure  and  the  characterization  of  the  risk.  Risk 
management,  on the  other hand,  is the process  of weighing  policy  alternatives  in the 
light  of  the  results  of  risk  assessment  and,  if  required,  selecting  and  implementing 
appropriate  control  options,  including  regulatory  measures.  While  the  task  of  risk 
assessment  may  be  delegated  to  scientific  advisory  bodies,  the  task  of  risk 
management  remains  the  responsibility  of  the  regulatory  authorities,  and  at 
Community level of Council, Commission and the European Parliament. 

Particular  difficulties  may arise in those cases where, because of scientific  uncertainty 
or  an  absence  of  data,  the  Scientific  Committees  are  unable  to  undertake  a 
comprehensive  risk  assessment.  In  such  cases,  in  accordance  with  the  obligation  to 
provide  a high  level  of protection,  it would  appear  necessary  to  take  a  conservative 
approach to risk management through the application of the precautionary principle. 

Likewise,  the  Community's  framework  research  programme  should  make  particular 
efforts  in  respect  of  research  and  applications  intended  to  improve  knowledge  and 
techniques making it possible to improve the assessment  of epidiemiological  and  food 
risks, and of the means of reducing such risks. 

A  further  problem  concerns  the  collection  of  the  data  which" is  necessary  for  the 
evaluation  of risk. In the  case  of new  substances,  the  applicant  is  clearly  responsible 
for  collecting  and  submitting  the  data  necessary  for  review.  In  order  to  assistant 
applicants,  guidelines  and  similar  documents  are  used  to  describe  the  information 
which will be necessary for  evaluation. However,  in the case of contaminants,  or new 
risk  factors  arising  for  existing  substances  there  may  be  difficulties  in  obtaining  the 
necessary  data.  In  order  to  meet  this  problem,  the  Community  has  established 
procedures  for  scientific  cooperation  between  Member  States  and  the  Commission 
for the examination of scientific  questions relating to  food. 

-37 

3. 

Scientific  cooperation  relating to food 

The  principles  of  the  scientific  cooperation  process  were  formalised  in  Directive 
93/5/EEC, on assistance to the Commission and cooperation by the Member  States in 
the scientific examination of questions relating to food,  adopted on 25 February  1993. 
The  Directive  sets  out  the  principle  that  Member  States  shall  take  the  necessary 
measures  to  enable  their  competent  authorities  and  bodies  to  co-operate  with  the 
Commission  and  lend  it  the  assistance  it  needs  in  the  scientific  examination  of 
questions  of public interest  relating  to  food,  particularly  in the field of public  health, 
through  disciplines  such  as  those  associated  with  medicine,  nutrition,  toxicology, 
biology,  hygiene,  food  technology,  biotechnology,  novel  foods  and  processes,  risk 
assessment techniques, physics and chemistry. 

In order to  enable the cooperation process to  operate effectively,  each Member  State 
is required  to  designate  a  single  authority  which  is responsible  for  cooperation  with 
the  Commission  and  distribution  of work  to  the  appropriate  institute.  The  principal 
tasks  to  be  carried  out  in the  scientific  cooperation  process  include  matters  relating 
to; 

the  drawing  up  of  protocols  for  the  assessment  of  risks  relating  to  food 
components and elaborating methods of nutritional  evaluation; 
assessing the nutritional adequacy of the diet; 
examining  test  data  submitted  to  the  Community  and  the  production  of  a 
monograph for the SCF; 
carrying out food  intake surveys; 
conducting investigations relating to the components of diets in various Member 
States or of biological or chemical food  contaminants; 
helping the Commission honour the Community's  international  commitments by 
providing expertise on food  safety questions. 

On the basis  of  suggestions  received  from  Member  States,  and  of its  own  priorities, 
the Commission  is required  to  prepare and update  an inventory  of tasks  for  scientific 
cooperation.  The  inventory  includes  a  summary  description  of the  task,  the  name  of 
the  co-ordinating  country,  the  name  of  the  other  countries  participating  in  the  task 
and the time limit for  its completion.  The  current  inventory  includes  a series  of tasks 
relating  to  the  collection  of  information  about  chemical  and  microbiological 
contaminants  of  foods,  flavours,  dietary  intake  and  exposure  assessments  and 
examination of scientific  aspects of nutrition. 

38-

The  management  of each  task  is the  responsibility  of the  coordinating  institute.  The 
Commission  undertakes  the  overall  management  of  the  scientific  co-operation 
process.  The  costs  of  the  tasks  are  primarily  met  by  the  Member  states  concerned. 
The Commission provides limited additional financial support to cover the extra  costs 
of coordinating  and convening meetings with experts from Member  States.  Although 
it is still too  soon to make a definitive judgement,  the preliminary results suggest  that 
scientific  cooperation  is  a  useful  and  very  cost  effective  method  of  pooling 
information  and resources on certain issues. 

On the other hand it is important to recognise the cornplementary nature of the role of 
the  scientific  cooperation  process  and  the  role  of  the  SCF.  In  the  area  of  risk 
assessment,  the  role  of  scientific  cooperation  is  to  collect  and  collate  the  best 
available  information  available  to  Member  States  on  a  particular  problem.  This 
information  is  then  transmitted  to  the  SCF  in  order  to  provide  a firm basis  for  the 
evaluation of risk by the SCF, which retains its role as the primary source of advice to 
the  Commission  on  scientific  questions  relating  to  food.  As  a  centre  of  independent 
scientific  expertise, the Joint Research Centre can also contribute towards this policy. 

4.  Management  of serious and  urgent  public health  risks 

Safeguard  clauses  are  included  in  all  Community  legislation  for  the  protection  of 
public health.  They allow Member  States to  apply restrictions  to  the  marketing  of a 
product  or  substance  if there  is good  reason  to  suppose that  it  constitutes  a  danger, 
even though it conforms  to  existing Community regulations. A rapid  alert  system was 
formally  established  in  1984  for  the  exchange  of  information  about  serious  and 
immediate risks to the health and safety  of consumers,  and  subsequently  incorporated 
into Directive 92/59/EEC. If necessary, the Commission  can convene meetings  of the 
relevant  scientific  committees at very short notice to consider the risk. 

Moreover,  with  the  completion  of  the  single  market  the  Community  received 
important powers, in particular under Directive 92/59/EEC  on general product  safety, 
to intervene and remove from the internal market  products which present  serious and 
immediate risks to  consumers. However,  in accordance with Directive  92/59/EC,  the 
Commission  can  only intervene  on the basis  of information  which  is received  from  a 
Member State. 

In  addition, the Commission  has adopted  a communication  on the handling  of urgent 
situations  in the  context  of the  implementation  of  Community  rules  (COM(93)  430 
final of  16 December  1993),  It  describes  the  machinery  already  in  place  in  various 
areas and proposes topics for consideration and discussion. 

39 

In addition, in the context of the veterinary health directives and Directive  93/43/EEC 
on  hygiene,  the  Commission  may  in  certain  cases  adopt  provisional  emergency 
measures,  which  are  effective  immediately,  subject  to  ratification  by  a  committee 
procedure  within  a very  short  period.  In its order  of  12 July  1996 in the  application 
for  interim  relief  brought  by  the  United  Kingdom  against  the  emergency  measures 
against BSE imposed by the  Commission, the  Court  of Justice recognised  that  in the 
application  of  these  procedures,  paramount  importance  must  be  accorded  to  the 
protection  of  public health,  even  at  the  expense  of  serious,  and  possibly  irreparable, 
damage to commercial and social interests. 

There  is  however  an  important  difference  between  the  scope  of  the  powers  of  the 
Commission under the safeguard  clauses in the veterinary directives and in the general 
hygiene  directive.  The  safeguard  clauses  in  the  veterinary  directives  apply  both  to 
risks arising from products imported from third  countries  and from products  in intra-
Community trade. The safeguard  clause contained in Article  10 of the general hygiene 
directive,  on  the  other  hand,  is limited  to  risks  arising  from  products  imported  from 
third  countries.  The Commission would  therefore  invite comments  on the  desirability 
of  extending  the  scope  of  the  latter  safeguard  clause  to  include  products  in  intra-
Community trade. 

Where  a  serious  risk  applies  to  several  categories  of  products  and  thus  triggers 
several  emergency  procedures,  there  must  be  adequate  coordination  to  ensure  the 
consistency of the various measures which are taken. It is also essential to  ensure that 
the  procedures  are  clearly  understood  by  all  those  concerned  in  managing  serious 
risks,  including  the  competent  authorities  of  the  Member  States,  consumers  and 
industry. 

Finally  experience  suggests  there  may  be  a  need  to  improve  arrangements  for  the 
management  of  and  responsibility  for  communication  to  the  public  in  the  event  of 
serious  risks.  The  operation  of  rapid  alert  and  safeguard  procedures  requires 
cooperation  and mutual  confidence  between Member  States  and  full  consideration  of 
the needs  of consumers  and industry. Whilst reliable information  about  serious  health 
risks  arising  from  foodstuffs  must  be  made  available  to  the  public  as  quickly  as 
possible,  it  is important  to  avoid  false  alerts  and  alarmist  messages.  In  some  cases in 
the past,  actions have been taken  affecting  a whole  product  category,  when  only one 
particular  product was involved. Whenever possible,  public information  and  warnings 
should  be targeted  at  specific  products  and  be  commensurate  with  the  nature  of the 
hazard. 

The  Commission  would  invite  comments  on  measures  which  might  be  taken  to 
improve the capacity of the Community to deal with serious and urgent risks to  public 
health relating to  foodstuffs. 

- 40 

5.  Radiological  Emergencies 

situations, 

In  normal 
situation),  protection  against 
contamination  of  foodstuffs  by  radio-active  substances  is  ensured  by  Council 
Directive 80/836/EURATOM, which will be repealed with effect  from  13 May 2000. 
This Directive is replaced by Directive 96/29/EURATOM. 

(i.e.  a  non-accidental 

Following  the  Chernobyl  accident,  a  number  of  provisions  dealing  with  accidental 
situations  have  also  been  adopted.  The  provisions  currently  in  force  following  the 
Chernobyl  accident  are  set  out  in  Council  Regulation  737/90  of  22  March  1990 
which  supplemented  and  adjusted  the  regulations  adopted  hitherto.  This 'Regulation 
will remain in force until the end of March 2000. 

The  system  that  will  be  applicable  in  case  of  future  accidents  is  laid  down  by 
Regulation  3954/87  of  22  December  1987,  which  provides  that  in  the  event  of  an 
accident, 
impose  predetermined  maximum  permitted 
contamination  levels.  This  emergency  action  may then  be  adjusted  according  to  the 
exact nature and scope of the incident  concerned. 

the  Commission  may 

Council Regulation  89/2219/EEC  of  18 July  1989 prohibits  the  export  of  foodstuffs 
with  a  contamination  level  exceeding  the  maximum  levels  permissible  within  the 
Community. 

On  14  December  1987,  the  Council  adopted  Decision  87/600/EURATOM  on 
Community  arrangements  for  the  exchange  of  information  in  the  event  of  a 
radiological  emergency.  According to this mechanism, the information  exchange  also 
covers activity levels measured  in foodstuffs  and drinking water. 

Zoonoses 

As  defined  in  existing  Community  legislation,  zoonoses  are  any  disease  and/or 
infection  which  is likely  to  be  naturally  transmitted  from  animals  to  man.  The  most 
important zoonoses which may be transmitted by food  include: 

viral contaminations, eg. Norwalk virus and hepatitis, type A, in shellfish; 

bacterial  infections,  eg.  Salmonella,  Campylobacter,  E.  coli, B melitensis,  bovine 
tuberculosis; 

bacterial intoxications, eg. Staphylococcal enterotoxaemia, botulism; 

protozoal parasites, eg Cryptosporidium,  Toxoplasmosis; 

cestode infections,  eg. Cysticercus bovis, cysticercus cellulosae; 

nematode infections,  eg Trichinellosis. 

41 

Specific  Community  rules have been adopted  in respect  of a number  of the  bacterial 
infections,  eg bovine tuberculosis,  bovine, ovine and  caprine brucellosis,  with  a view 
to their control and eradication in the animal population (and thereby their elimination 
from the human population). These programmes are based  on the principle of testing 
live  animals  and  the  slaughter  of  any  giving  a  positive  reaction.  In  some  cases, 
vaccination  is  also  employed  as  a  means  of  reducing  infection  levels  in  the  animal 
population.  Considerable  success has been achieved  in respect  of bovine  tuberculosis 
and brucellosis, although matters are less well advanced for ovine/caprine brucellosis. 

All of the Community legislation concerning the hygiene of products  of animal  origin 
intended  for  human  consumption  includes provisions which will  serve to  control  the 
risk  of  spread  of  zoonoses  from  the  animal  to  the  human  population.  These  range 
from the specific,  eg ante and post mortem inspection of animals in abattoirs,  through 
to  the  general,  eg  requirements  for  hygienic  construction  and  operation  of  food 
processing  premises  and  provisions  for  minimum  processing  conditions  and  storage/ 
transport temperatures. 

In  addition  to  these  vertical  Directives  which  provide  directly  or  indirectly  for  the 
control  of  zoonoses,  the  Council  has  adopted  Directive  92/117/EEC  concerning 
measures  for  protection  against  specified  zoonoses  and  specified  zoonotic  agents  in 
animals  and  products  of  animal  origin  in  order  to  prevent  outbreaks  of  food-borne 
infections  and intoxications.  The requirements of the Directive are, in essence,  aimed 
at the monitoring  and  control of a series of zoonoses. Member  States  are required  to 
report  yearly  on  the  occurrence,  trends  and  sources  of  zoonotic  infections  (in  the 
human  population,  domestic  animals,  animal  feedingstuffs  and  wildlife)  recorded 
during the  previous year.  The Directive also provides for  actions to  monitor,  control 
and  ultimately  to  eradicate  some  invasive  salmonella  serotypes  in  poultry  breeding 
flocks. 

Experience  suggests  that  some  of the time  limits  for  Member  States  to  take  certain 
measures  were  over-optimistic  and  that  certain  technical  provisions  of  the  Directive 
need to be reviewed. 

The  Commission  therefore  invites  comments  on  possible  improvements  to  this 
Directive. 

Options  For  Control  Of Zoonoses 

By  their  very  nature,  zoonotic  agents  can  be  found  in  at  least  two  host  species.  In 
many  cases,  eg  Salmonella,  a  wide  range  of  different  hosts  may  be  infected,  with 
clinical  disease  not  necessarily  being  evident  in  all  affected  animals.  It  follows  that 
control  and  eradication  programmes  can  intervene  at  a number  of  different  points in 
the  infective  cycle,  and that  it  may be  necessary  to  use  more than  one  approach.  In 
addition  to  the general  principles  of good  hygiene  at  all  stages  of the  food  chain,  as 
dealt with elsewhere in this Paper,  specific  strategies include: 

- 4 2-

- 

- 

- 

eradication  of the agent from the animal population or the environment 

reduction in the level of infection  in the animal population to a point where it no 
longer  poses  a  threat  to  human  health,  eg  processing  of  animal  feedingstuffs, 
vaccination  programmes,  treatment  of  infected  animals  and  destruction  of 
clinically infected  animals 

removal  of the  agent  from  the  food  chain,  eg  by  specific  treatment  during  the 
processing of the raw material, such that any agent is destroyed 

Eradication  is an expensive option, not  only because  of the need  to  organise  labour 
and resource intensive testing programmes, but also to  destroy infected  animals. It is 
dependent upon the existence of an adequately  sensitive and  specific  live animal test, 
as  well  as  support  from  the  farming  community.  Furthermore,  success  can  only  be 
anticipated  where  the  disease  has  a  limited  host  range  (with  no  significant  wildlife 
involvement).  This  approach  can be justified  where  significant  public  health,  animal 
health  or  economic  problems  are  posed  by  the  disease,  eg  bovine  tuberuclosis, 
brucellosis. 

Reduction  involves a series of different  measures aimed at different  points in the live 
animal  production  cycle.  It  is  often  used  as  a  precursor  to  a  full  eradication 
programme. Even where this is not the intention,  a coordinated  programme to  reduce 
disease levels in the  animal population  can have a significant  impact  on the  degree to 
which  the  consumer  is  exposed  to  risk  of  infection.  Such  programmes  generally 
require  a high  degree  of cooperation  between  farmers,  suppliers,  processors  and  the 
official  services. 

Removal  of  the  agent  from  the  food  chain  generally  involves  the  treatment  of  the 
food  by  a  specific  method,  irrespective  of  whether  the  agent  is  present.  It  is 
particularly useful  where the detection of the infective  agent is either too  expensive or 
unreliable.  It  can  include  heat  treatment,  drying,  curing,  pickling,  freezing  etc. 
Although  effective,  this  approach  does  not  generally  preclude  the  possibility  of 
reinfection,  eg  cooked  meat  stored  with  raw  meat  is  often  implicated  in  food 
poisoning outbreaks." 

43 

7. 

Introduction  of a general obligation to ensure that food  is safe and  wholesome 

Existing  Community  legislation  imposes  a  series  of  specific  obligations  on  food 
producers  to  ensure  that  foodstuffs  meet  the  requirements  laid  down  in  the 
Community rules. At national level, however, certain Member States have gone a step 
further.  In  addition  to  transposing  existing  Community  legislation,  they  have  also 
introduced  into  their  domestic  legislation  a  general  obligation  of  food  safety.  Thus 
food  businesses are required to ensure that only food which is safe, wholesome and fit 
for  human  consumption  is placed  on the market.  Any food  business which markets a 
food  which  is  not  safe,  wholesome  and  fit  for  human  consumption  will  commit  an 
offence  under the law of the Member  State concerned,  and will be liable to  a criminal 
or administrative penalty. 

The objective of this section is to invite comments on whether it would be appropriate 
to  introduce  at  Community  level  a  similar  general  obligation  on  food  businesses  to 
ensure that food  is safe, wholesome and fit for  human consumption.  It is important  to 
emphasise  that  such  a general  obligation  of  safety  and  wholesomeness  would  be  an 
obligation  owed  by  food  businesses  directly  to  the  competent  authorities  under  the 
penal  or  administrative  law of the Member  State  concerned.  It  would  thus  be totally 
separate  from  the  question  of  the  liability  of  producers  to  consumers  for  defective 
products,  which  is  covered  in  the  following  section.  Moreover,  the  introduction  of 
such a general  obligation would  not  entail  the  introduction  of new  prior  approval  or 
notification  systems by Member  States. 

7.1  The current situation at  Community  level 

Although  Community food  legislation  sets out a series of specific  obligations  on  food 
businesses,  with  the  exception  of  the  general  Product  Safety  Directive,  it  does  not 
currently  contain  a general  legal  obligation  that  only  food  which  is  safe,  wholesome 
and fit for  human consumption  should  be placed  on the market.  Individual  Directives 
approach  the  question  in  different  ways:  there  is  an  explicit  requirement  in  some 
vertical  hygiene Directives  for  certain  products  to  be fit for  human  consumption;  an 
implicit  requirement  for  this  in  other  vertical  Directives;  and  a  requirement  in  the 
general  hygiene  Directive 
the  "preparation,  processing,  manufacturing, 
packaging,  storing,  transportation,  handling  and  offering  for  sale  or  supply  of 
foodstuffs  shall be carried out in a hygienic way". 

that 

-44 

safety 

imposes  on 
Article  3(1)  Directive  92/59/EEC  on  general  product 
manufacturers  the  obligation  to  place  only  safe  products  on  the  market.  However, 
doubts have been expressed  as to whether the concept  of product  safety  which is laid 
down by Directive 92/59/EEC is rather different from the requirement that  foodstuffs 
should be safe, wholesome and fit for human consumption. For example, food  may be 
adulterated  with  substances  which  do  not  of  themselves  present  a  health  risk,  and 
would  not  make  the  foodstuff  unsafe  within  the  meaning  of  Directive  92/59/EEC. 
Nevertheless,  such  foodstuffs  would  not  normally  be  considered  as  fit  for  human 
consumption. 

The  introduction  of  a  general  obligation  of  food  safety  and  wholesomeness  would 
thus  serve  to  reinforce  the  overall  level  of  consumer  protection  within  the 
Community, by encouraging  all food  businesses to introduce their  own internal  safety 
and  supervision  procedures.  This  obligation  of  safety  may  also  help  simplify  overall 
Community  food  legislation,  since  it  would  avoid  the  need  for  more  specific 
regulations  in  areas  where  the  general  provisions  would  be  sufficient  to  guarantee 
product  safety. However,  it would also be necessary to ensure that the introduction  of 
a  new  obligation  of  safety  and  wholesomeness  does  not  result  in  the  creation  of 
barriers to trade within the internal market.  Thus, all measures  should  be  compatible 
with the principles  of the  internal  market,  and  particular  the  Treaty  rules  on the  free 
movement of goods. 

7.2  Scope of the general  obligation  of safety  and  wholesomeness 

In  order  to  be  effective,  any  new  general  obligation  of  safety  and  wholesomeness 
should in principle apply to the whole food  chain from primary production to the  final 
sale  of  the  foodstuff  to  the  consumer.  It  must  also  take  account  of  the  fact  that 
interactions  between  producers,  manufacturers  and  distributors  are  becoming 
increasingly  complex.  Thus  for  example,  in  many  cases  primary  producers  have 
contractual  obligations  to  manufacturers  or  distributors  to  meet  specifications  which 
cover  quality  or  safety.  Distributors  increasingly  have products  produced  under  their 
own brand-name and play a key role in product conception and design. 

This  new  situation  should  result  in  greater  joint  responsibility  throughout  the  food 
chain,  rather  than  dispersed  individual  responsibilities.  Each  link  in  the  food  chain 
should  take  the  measures  necessary  to  ensure  food  safety  within  the  context  of  its 
own  specific  activities,  applying  HACCP-type  principles,  and  other  similar 
instruments.  Where  a product  is found  to  be not  up  to  standard,  the  liability  of  each 
link  in  the  chain  should  be  reviewed  according  to  whether  or  hot  it  has  properly 

-45 

fulfilled  its  own  specific  responsibilities.  For  example,  it  would  appear  wrong  in 
principle to  hold  a food  retailer  responsible for  the presence  of an excessive  quantity 
of  food  additives  in  a  canned  product  over  which  the  retailer  has  no  control. 
However,  where  cooked  sliced  cold  meats  are  found  to  be  microbiologically 
contaminated  at the  point  of  sale, further  investigation  will be required  to  determine 
whether  the  contamination  arose  as  a  result  of  poor  hygiene  during  manufacture,  a 
failure  to  respect  the  cold  chain during  distribution  or  poor  handling  and  storage  at 
the point of sale. 

This  raises  the  question  of  the  so-called  "due  diligence"  defence.  When  a  food 
business  markets  a  foodstuff  which  does  not  conform  to  the  safety  requirements 
prescribed  by Community  or  national law, that  business  may  be  liable to  criminal  or 
administrative  penalties undef  the  law of the Member  State  concerned.  However,  in 
some Member  States  the  business  will not  be  liable  if it  can  demonstrate  that  it  has 
taken  all the  steps which  could  reasonably  be  expected  of  it  to  ensure  that  the  food 
meets  the  legal  requirements  ("due  diligence").  Thus,  compliance  with  the  due 
diligence  obligation  constitutes  an  absolute  means  of  defence  in  any  subsequent 
judicial  or  administrative  procedure.  In  other  Member  States  however,  the  operator 
will still be liable, although the fact  that the company has exercised  due diligence will 
be taken into account in order to reduce the severity of the penalties imposed. 

During preliminary consultations, the Commission received  a number  of requests  that 
the  introduction  of  a  general  obligation  of  food  safety  into  Community  legislation 
should be accompanied by the introduction  of a "due diligence"  defence. 

The  Commission  is  aware  that  determining  the  facts  and  circumstances  which  may 
render  an  operator  liable  to  criminal  or  administrative  penalties  is  a  complex  matter 
which depends very much on the structure of the different  national legal systems. 

However, it also considers that taking account of the  obligation to take all reasonable 
care  to  ensure  food  safety  in  the  sanctions  system  is  an  important  means  of 
recognizing the responsibility  of companies  to  ensure  that  their  products  conform  to 
the  regulations.  Accordingly,  failure  to  fulfil  the  obligation  should  result  in  tougher 
penalties  where  products  do  not  conform  to  the  regulations,  while  fulfilment  of  the 
obligation should result either in application of the defence  of due diligence or at least 
in less severe penalties. 

The question  of the  "due diligence"  defence  should  also  be  considered  in  connection 
with  the  possibility  of  extending  the  scope  of  the  obligation  of  safety  to  primary 
production. 

The Commission would welcome detailed comments on these matters. 

46-

8.  Application of the principle of product liability in the foodstuffs  sector 

Council  Directive  85/374/EEC  on  liability  for  defective  products  establishes  the 
principle  that  a  producer  will  be  liable  for  a  defect  in  his  product.  The  Directive 
applies  to  foodstuffs  as  well  as  to  other  products.  However,  the  definition  of  a 
product in Article 2 of the Directive excludes primary agricultural products and game. 
For the purposes of the directive, primary agricultural products means the products of 
the soil, of  stock-farming  and  of fisheries, excluding  products which have undergone 
initial processing. In principle, therefore,  unprocessed  agricultural products  and game 
are  excluded  from  the  scope  of  the  product  liability  directive,  although  Member 
States  may  choose to  provide that  these  products  are  covered.  So  far,  only  Greece, 
Luxembourg, Finland and Sweden have  availed themselves of this option. 

In  recent  years,  increasing  demands  have  been  heard,  in  particular  from  consumer 
organisations, for the inclusion of unprocessed  primary agricultural production within 
the scope of the product liability directive. These demands have increased  recently,  as 
a result of the BSE scare. 

In principle,  the  inclusion  of unprocessed  primary  agricultural  production  within  the 
scope  of  the  product  liability  directive  would  constitute  an  important  step  in  the 
protection  of consumers under Community  legislation. Nevertheless,  it  should  not  be 
thought  that  such an extension would  constitute  a solution to  all the  problems which 
may arise. Article 4 of the Directive provides that the injured  person  shall be required 
to  prove  the  damage,  the  defect  and  the  causal  relationship  between  the  defect  and 
the damage. Experience  has  shown that  it is very  difficult  to  trace the precise  source 
of  outbreaks  of  food-borne  disease.  The  longer  the  period  between  exposure  to  the 
contaminated  foodstuff  and  the  onset  of  symptoms,  the  greater  these  difficulties 
become. In the  specific  case of BSE,  even if a link is proved  with the  new variant  of 
Creutzfeldt Jakob Disease, the very long incubation period involved  means that it will 
probably  be  impossible  to  prove  that  a  particular  product  is  responsible  for  the 
damage caused. 

A further  question  concerns  the  difficulty  of tracing  the  origin  of the  foodstuff  from 
the  point  of  sale to  the  consumer  back  to  the  point  of  production.  The  Community 
has recently  adopted  measures to  ensure the traceability  of products  of bovine  origin 
back  to  the  point  of  production  and  it  has  been  suggested  that  these  rules  might  be 
extended  to  other products  of animal origin.  Consideration  is also needed  of whether 
further  rules  on  traceability  should  be  laid  down  in  legally  binding  instruments,  or 
whether  these would  better be covered  by voluntary  instruments.  A number  of  major 
food  retailers  and  distributors  are  known  to  be  developing  systems  to  improve  the 
traceability  of  foodstuffs.  In  this  context  it  should  be  noted  that  Article  1(3)  of  the 
product  liability directive provides that  "where the producer  of the product  cannot  be 
identified,  each supplier shall be treated as its producer..." 

47 

In these circumstances, it would appear that the extension of the scope of the product 
liability directive to  cover unprocessed  primary agricultural  production  should  not  be 
considered  as  an  alternative  to  the  development  of  appropriate  product  safety  rules 
and  effective  official  control  systems  but  as  an  additional  measure  in  its  own  right. 
The Commission would invite comments on this question. 

9  Meeting the new aspirations of consumers 

The principal  concern  of Community  food  law until now has been to  ensure the  free 
circulation  of  foodstuffs 
in  the  Community,  largely  through  harmonized  food 
legislation.  In  contrast,  Community food  law has not  dealt  to  any great  extent  either 
with  nutritional  issues  or  with finding ways  of meeting  public  concerns.  This  Green 
Paper,  coming  as it  does  at  a time when  public  concerns  about  food  and  health  are 
high,  provides  an  opportunity  to  launch  a  debate  about  new  approaches  to  these 
issues, both within general food  policy and specific legislation. 

Food law constitutes one of the main components of a policy on food  and nutrition.  It 
could play a role in increasing the awareness  of Community  citizens  about  their  food 
purchases,  diets  and  meal  preparation,  and  could  help  encourage  them  to  make 
healthy  choices which would  lead to  improved  health  and the  reduction  of  morbidity 
and  premature  mortality.  In  this  process,  a  collaborative  effort  of  the  health  sector, 
consumers, governments, industry and the Community itself would benefit  all parties. 

The  Commission  invites  comments  on  what  approach  should  be  followed  at 
Community  level  with  regard  to  nutrition  and  health,  which  initiatives  should  be 
pursued  and where this would require adaptations of Community food  law. 

In  addition,  consumers  have  become  increasingly  concerned  about  the  methods  by 
which their foods  are produced. Increasing numbers of consumers wish to ensure that 
the foods  which they eat  are produced  in a manner which is environmentally  friendly 
and  which  meet  the  welfare  needs  of farm  animals. Recent  events,  and  in  particular 
fears  about  the  possible  transmission  of BSE  to  humans,  have  highlighted  concerns 
that certain production methods may also have an impact on food  safety. 

Other  discussions  have  focussed  on  the  ethical  and  environmental  impact  of  new 
scientific  developments  such  as  GMOs  in  foodstuffs  and  the  application  of  cloning 
techniques. 

48 

Community  legislation  already  contains  many  provisions which  are intended  to  meet 
these  concerns.  Strict  rules  govern  the use  of  pesticides  and  veterinary  medicines  in 
food  production,  in  order  to  ensure  that  such  use  is  kept  to  the  minimum  which  is 
compatible with good  agricultural  or veterinary  practice. Limits are being  established 
to  ensure  that  residues  of  pesticides  and  veterinary  medicines,  and  contaminants  of 
agricultural or environmental  origin do not  present  a risk to  the health  of consumers. 
The  Community  has  also  adopted  rules relating  to  the  welfare  of  farm  animals. The 
details  of  such  rules  fall  outside  the  scope  of  this  Green  Paper.  Nevertheless,  they 
give rise to two important  issues of direct relevance to food  law: the  safety  issue and 
the question of consumer  information. 

So far  as food  safety  is concerned,  there  is no  scope  for  compromise.  The  previous 
sections  of  this  part  have  described  how  risk  assessment  and  risk  management 
techniques are integrated  into the Community's policies for the foodstuffs  sector.  The 
maintenance  of  a  high  level  of  protection  implies  that  it  would  not,  however,  be 
appropriate  to  authorize  unsafe  foods  or  food  production  methods  subject  to  a 
labelling requirement. If they are not safe, they cannot be permitted. 

So  far  as  labelling  is  concerned,  at  present,  Directive  79/112/EEC  only  requires 
information  on processes  or treatments to  be provided  on food  labels in cases where 
the  omission  of  such  information  is  likely  to  create  confusion  in  the  mind  of  the 
consumer,  for  example  where  products  are  powdered,  freeze  dried,  deep-frozen, 
concentrated  or  smoked.  In  addition  irradiated  foodstuffs  must  always  be  labelled. 
However,  Community  legislation  does  not  require  the  labelling  of  production 
methods  or processes which do not have an impact  on the food  characteristics  of the 
finished  product.  There  have  recently  been  extensive  discussions  between  the 
Parliament,  Council  and  Commission  on  the  extent  to  which  a  systematic  labelling 
requirement  should  be  imposed  on  foodstuffs  produced  by  modern  biotechnology 
during  the  examination  of  the  Commission's  proposal  for  a  Regulation  on  Novel 
Foods and Novel Food Ingredients. 

In  general,  experience  suggests  that  where  there  is  a genuine  consumer  demand  for 
more information  about  certain aspects  of a foodstuff,  this demand  will frequently  be 
met by producers and distributors on a voluntary basis, for  example through labelling, 
telephone  information  lines or the Internet.  It  may be necessary to  consider  the  need 
for  new  Community  measures  to  encourage  the  development  of  such  voluntary 
initiatives.  Moreover,  in  certain  cases,  such  as  the  recent  beef  labelling  scheme, 
further  mandatory  measures  may  be  appropriate.  The  Commission  would  invite 
comments on this question. 

49 

PART  V 

ENSURING THE EFFECTIVE IMPLEMENTATION  OF 
INTERNAL MARKET RULES 

1.  General  considerations 

Now  that  the  harmonization  of  national  foodstuffs  legislation  has  largely  been 
completed,  it  is  necessary  to  ensure  that  the  internal  market  operates  effectively  in 
order to provide the benefits anticipated for producers and consumers. 

The need  to  ensure efficient  management  of the  internal  market  has been  recognised 
by  the  Sutherland  Report  of  October  1992:  "The  Internal  Market  after  1992; 
Meeting  the  Challenge"  and  by  the  European  Council.  A  series  of  Commission 
communications to the Council have also emphasised  the need  for  efficient  operation 
of the internal market: 

Management  of the mutual recognition  of national  rules  after  1992 (COM  (93) 
669 final, 15 December  1993) 
Development  of  administrative  cooperation  for 
implementation  and 
application  of  Community  legislation  in  the  framework  of  the  internal  market 
(COM (94) 29 final, 16 February  1994) 
Making  the  most  of  the  internal  market  (COM  (93)  632  final,  22  December 
1993). 
the action plan for the Internal Market (COM (97)  184) 

the 

More  recently, the Internal market  Council  has adopted  a series  of resolutions  which 
are  intended  to  ensure  that  the  rules  governing  the  operation  of  the  internal  market 
are  as  simple  and  straightforward  as  possible.  The  possibilities  for  the  simplification 
of Community  food  law have been  extensively  considered  in Part  II,  and  will not  be 
repeated here. 

The  objective  of  this  Part  is  to  review  the  current  arrangements  for  ensuring  the 
effective  implementation  of Community  legislation within the internal  market,  and  to 
invite suggestions for  improvements. 

2. 

Transposition  and  application  of Community  law 

In order to  ensure the proper functioning  of the internal market,  it is clearly necessary 
to  monitor  of  the  transposition  of  Community  directives  by  Member  States  and  to 
verify  that  the  Community  rules  are applied  correctly.  The Commission  has  arranged 
for  a series  of specific  studies on the implementation  of the foodstuffs  directives,  and 
the results  of these  studies are being analysed.  Cases of incorrect  implementation will 
be pursued with the Member  States concerned. 

50-

In  addition  to  national  legislation  transposing  Community  legislation,  it  is  common 
practice  for  the  national  authorities  to  issue  implementing  instructions  or  guidelines 
for  enforcement  for  official  control  bodies,  especially  when  the  legislation  is  very 
broad  in scope.  Such guidelines are intended  to  ensure that the  legislation is applied 
uniformly  throughout  the  Member  State  concerned,  and  to  resolve  practical 
implementation problems. 

Nevertheless,  such  guidelines  may  cause  problems  for  management  of  the  internal 
market when Member  States adopt different  interpretations of the legislation, with the 
result  that  provisions  are not  applied uniformly  throughout  the internal  market.  It  is 
important  therefore  that  transparency  be  maintained  at  Community  level* and  that 
these differences  be resolved wherever there is divergence. 

For  several  years,  the  Commission  has  followed  an  informal  working  practice  of 
submitting  questions  concerning  the implementation  of  Community  legislation  to  the 
Standing  Committees.  A  similar  approach  has  been  followed  when  unforeseen 
difficulties  have arisen during the implementation of the legislation. In many instances, 
these discussions have resulted in agreement between the competent  authorities of the 
Member  States and the Commission about the manner in which the legislation is to be 
interpreted  or  applied.  The  Commission  considers  that  this  is  a  useful  procedure 
which  should  continue,  and  that  the  conclusions  of  the  Committee  should  be  made 
more widely  available to  interested  parties, it being understood  that  such  conclusions 
have no formal  legal  status,  and that in the event  of a dispute,  ultimate  responsibility 
for the interpretation  of Community law lies with the Court of Justice. 

Finally, in the interests of transparency,  all parties concerned  should be encouraged  to 
discuss  the  implementation  and  application  of  Community  legislation  openly  in  a 
forum  where  Member  States  can  be  consulted  and  where  different  socio-economic 
interests can express an opinion.  To this end the Commission would  invite  comments 
on the desirability  of convening periodic meetings with  representatives from Member 
States,  producers,  industry,  commerce  and  consumers  to  discuss  general  issues 
relating to the implementation of Community legislation. However,  matters relating to 
the  non-compliance  of  national  legislation  with  Community  law  would  be  excluded 
from  the  scope  of such meetings,  and would  continue to be  dealt  with  in  accordance 
with established  Commission procedures. 

3. 

Control  and  enforcement 

In accordance with the Treaty, responsibility for  control  and  enforcement  of EC  rules 
primarily  rests  with  the  competent  authorities  of  the  Member  States.  Community 
legislation has followed  the traditional practice in the Member  States which lays down 
specific  rules for  the inspection  of foods  of animal origin and  more general  principles 
for the inspection of other  foods. 

-51 

The main role  of the  Community  in the field of control  is not  to  replace  the  control 
and enforcement  activities of the competent  authorities  of the Member  States, but  to 
control  the  manner  in  which  they  are  implementing  the  relevant  legislation  in  their 
own countries. 

In  order  to  guarantee  the  independence  and  effectiveness  of  control  activities 
undertaken  at Community level, the Commission has reviewed  the  organisation  of its 
inspection  and  control  services  and  has  submitted  to  the  Council  and  the  European 
Parliament a Communication on its future policy in this field. In view of the important 
contribution  of  control  activities  to  effective 
implementation  of  Community 
legislation, which is a matter of common effort  between the Commission and national 
authorities, the Commission is willing to receive comments from interested  parties on 
its new policy. 

3.1  Veterinary  controls 

Legislation  on  controls  in  the  veterinary  sector,  on  foods  of  animal  origin,  is  fully 
harmonized  at  Community  level  by  vertical  Directives  which  lay  down  the  control 
provisions  for  each  product  or  class  of  products  (fresh  meat,  poultry  meat,  meat 
products,  fish  and  fishery  products,  milk  and  milk  products,  etc).  These  rules  are 
currently being reviewed with the aim of producing a codified,  simplified,  version (see 
part II, paragraph  8.1). 

In the  existing hierarchy  of controls,  the producer  is responsible  in the first place  for 
producing  food  which  is fit for  human  consumption;  the  national  control  authorities 
are  responsible  for  the  day-to-day  enforcement  of  the  Community  rules  for  the 
specific  products  concerned;  and the Commission is responsible for  checking that  the 
national  authorities  are  applying  the  Community  rules  effectively  and  uniformly.  It 
will  be  necessary  to  examine  this  present  division  of  responsibilities  for  control  of 
food.  This  question  will  need  to  be  addressed  as  part  of  the  ongoing  simplification 
exercise for  veterinary legislation,  as well as in the light of the  Commission's  internal 
review of its inspection and control services. 

The  Commission  sponsors  regular  training  courses  which  bring  together  veterinary 
inspectors  from  several  Member  States  to  coordinate  their  approach  to  the 
application of Community legislation 

52 

The Commission's  Community  Office  of Veterinary  and Phytosanitary Inspection  and 
Control  has been  responsible  for  carrying  out  on-the-spot  checks  in Member  States, 
and in third  countries  exporting  animals  or  animal  products  to  the  Community.  The 
Office  has recently  been transferred  to Directorate  General XXIV  "Consumer  Policy 
and Health  Protection,  and  in  recognition  of  its  new  functions,  if  has  been  entitled 
"EC  Office  for  Product  Quality  Control  and  Audit.  The  role  of  the  Office  is  to 
monitor 
the 
implementation  of relevant  Community legislation,  rather than to  substitute for  them, 
rather than to  substitute for them. The office  is presently  able to  cover  only a part  of 
its duties as specified  in Community legislation. 

the  performance  of  national  control  authorities 

in  checking 

The  Commission  has  reviewed  the  role,  responsibilities  and  manner  of  operation  of 
this  Office,  and  has  submitted  to  the  Council  and  the  European  Parliament  a 
Communication on this matter. 

3.2  Other  Official  Controls  of  Foodstuffs 

Community  legislation  has laid  down the  general  principles  of  the  official  control  of 
foodstuffs.  Control  consists  of  inspection,  sampling  and  analysis,  inspection  of  staff 
hygiene,  examination  of  written  and  documentary  material  and  examination  of 
verification  systems  set  up  by  undertakings.  Inspections  shall  cover  all  stages  of 
production,  manufacture,  import  into the Community,  processing,  storage,  transport, 
distribution  and  trade.  Products  which "are intended  for  consignment  to  another  EC 
Member  State  must  be  controlled  with  the  same  care  as  products  intended  for 
marketing  in the Member  State concerned,  and  a product  must  not  be  excluded  from 
control simply because it is intended for export from the Community. 

In addition,  procedures  have been developed  for  administrative  cooperation  between 
the Member  States on matters relating to  control  and  enforcement  in order  to  ensure 
that  the  necessary  controls  are  being  carried  out  effectively  and  equivalently  across 
the  Community.  Thus,  each  year  the  Commission  establishes  a  coordinated 
programme  for  the  control  of  foodstuffs.  The  Member  States  exchange  statistical 
information  about  the  operation  of  the  control  systems,  the  number  of  inspections 
carried  out  and  the  nature  of the  infringements  found.  The  competent  authorities  of 
the Member  States  are  required  to  afford  each  other  administrative  assistance  in  all 
supervisory  procedures  relating  to  the  legal  provisions  and  quality  standards 
applicable  to  foodstuffs  and  in  all  proceedings  for  the  infringement  of  foodstuffs 
legislation. Exchanges of national food  inspectors  are taking place within the Karolus 
programme.  In  addition,  a  small  centralized  Community  food  control  unit  has  been 
established  to  verify  the  equivalence  and  efficiency  of  the  national  control  systems. 
These  inspectors  are  currently  completing  their  programme  of  first  visits  to  each  of 
the Member  States. 

- 5 3-

The objective  of these activities is to facilitate  the operation  of the internal market by 
establishing  mutual  confidence  between  the  national  inspectors,  thus  removing  the 
need to repeat controls for products produced in other Member States. 

Nevertheless,  it  should  be  emphasised  that  the  official  inspectorates  of  the  Member 
States  have  limited  resources  and  cannot  inspect  every batch  of  every  product  on  a 
market  where  the  consumption  of  foodstuffs  is  evaluated  at  some  ECU  500,000 
million. 

Moreover,  systematic  official  inspections  would  not  be  appropriate  in  view  of  the 
quality and safety control procedures developed in the industry in recent years. 

For  this  reason,  official  inspections  in  all  industrialized  countries  are  focusing 
increasingly  on  the  suitability  and  reliability  of  companies'  own  internal  control 
procedures  for  meeting  product  conformity  objectives.  This  means  that  public 
resources  are used  more  efficiently,  since inspection  authorities  can  concentrate  their 
efforts  on those companies whose activities give grounds for  concern,  and reduce the 
frequency  of  official  inspections  of those  companies  which  have  introduced  reliable 
and suitable control systems. 

It  would  therefore  seem  appropriate,  if a  safety  obligation  is to  be  imposed  on  food 
companies, to include in Community provisions a general requirement that the  official 
inspectorates  should  determine the intensity  and frequency of inspections  not  only in 
accordance  with  the  level  of  risk  presented  by  foodstuffs  and  the  operations 
concerned,  but  also  as  a  function  of  the  suitability  and  reliability  of  internal 
procedures  introduced  by  companies  for  ensuring  and  verifying  that  foodstuffs 
conform  to  the  required  standards.  Applying  this  principle  would  bring  the  general 
provisions  on  the  inspection  of  foodstuffs  into  line  with  Article  8  of  the  general 
directive on food  hygiene, which states that all food  premises should be inspected  at a 
frequency  which has regard  to the risk associated  with the premises. In  addition,  due 
account  should  be taken,  in the  operation  of the  control  systems  of new tools  which 
are being developed by the industry such as indicators of freshness which may be used 
to indicate whether there has been a break in the cold  chain during the distribution  of 
a product. 

Finally,  concerns  have  been  expressed  about  the  lack  of  transparency  of  certain 
aspects  of food  inspection  and  control  activities,  and  the  lack  of  consumer  access  to 
the  work  of  the  inspection  systems.  These  questions  have  been  addressed  in  the 
Commission's Communication  on Consumer Health and Food  Safety. 

54 

4. 

Sanctions 

In its Communication  on the role of sanctions  in the  implementation  of  Community 
legislation in the field of the internal market (COM (95)  162 final), the  Commission 
concluded  that  the  sanctions  laid  down  by  Member  States  for  the  infringement  of 
internal  market  legislation  should  be  equivalent  to  the  sanctions  set  out  in  the 
corresponding  provisions  of  national  legislation,  effective,  proportionate  and 
dissuasive. These general principles were endorsed by the Internal Market Council in 
its resolution of 6 June  1996. It would therefore  appear that these  principles  should 
be  introduced  into  Community  food  legislation.  The  Commission  would  invite 
comments on this question. 

5.  Management  of the Internal Market in non-harmonized  areas 

In sectors which have not been harmonized  at  Community level, the jurisprudence  of 
the  Court  of Justice  provides  a basis  for  ensuring  the  free  movement  of  foodstuffs. 
The  primary  instrument  for  the  management  of  the  internal  market  remains  the 
application  of the  principle  of mutual  recognition,  as  it  results  from  the  case  law  of 
the Court of Justice following the Cassis de Dijon judgement. 

In its interpretative  communications,  the Commission  has presented  its  interpretation 
of the  principles  concerning  the free movement  of foodstuffs  in the  light  of the  case 
law of the  Court.  For  example, in its  1989 Communication  on the free movement  of 
foodstuffs  within  the  Community,  the  Commission  set  out  its  interpretation  of  the 
rules  applicable  in  the  absence  of  Community  legislation.  The  Member  States  are 
required  to  admit to  their territory  foodstuffs  lawfully  produced  and  marketed  in the 
other  Member  States.  The  importation  and  marketing  of  such  foodstuffs  may  be 
restricted,  in the absence of harmonized  rules at Community  level,  only where  such a 
measure 

can be demonstrated  to be necessary in order to  satisfy  mandatory  requirements 
(public  health,  protection  of  consumers,  fairness  of  commercial  transactions, 
environmental protection); 

is proportionate to the desired objective, and 

is the means of achieving that objective which least hinders trade. 

In these  communications,  the Commission  also described  the major  specific  problems 
which concerned the free movement of foodstuffs,  namely: 

trade description (i.e. the name under which imported foodstuffs  can be sold); 

the presence of additives in  foodstuffs. 

-55 

Subsequently,  the  major  problems  described  in the  Communications  appear  to  have 
been  largely  resolved,  either  as  a  result  of  the  harmonisation  of  legislation  or  as  a 
result  of  developments  in the  case  law  of the  Court.  However,  other  problem  areas 
have emerged, such as those mentioned in Part II, Section 8. 

Hitherto,  the  Commission  has  disposed  of  two  main  mechanisms  for  managing  the 
internal market in non-harmonised  sectors; 

the examination of draft  national technical  regulations which have been  notified 
in accordance with Directive 83/189/EEC (considered in Part II section 7) 

the  investigation  of  complaints  that  Member  States  are  infringing  the  rules  on 
the free movement of goods laid down by Articles 30-36  of the Treaty.  Despite 
a certain reticence on the part  of industry to bring forward  formal  complaints to 
the  Commission,  the  foodstuffs  sector  still  accounts  for  the  largest  number  of 
complaints  received  by  the  Commission  under  Arts  30-36  of  the  Treaty.  The 
Commission  has  taken  a  number  of  initiatives  to  rationalise  and  expedite  the 
complaints  procedures.  In  addition,  the  possibility  of  pursuing  a  complaint 
before  the  national  courts,  and  if necessary  obtaining  a preliminary  ruling  from 
the  Court  of Justice  in  accordance  with  Article  177,  constitutes  an  alternative 
means of redress 

From  1  January  1997, the Commission has had available an important new mechanism 
for  the management  of the  internal  market.  In  accordance  with  the  provisions  of the 
Decision  of  the  European  Parliament  and  the  Council  establishing  a  procedure  for 
mutual  information  on  national  measures  derogating  from  the  principle  of  the  free 
movement of goods within the Community, Member  States are required  to  inform  the 
Commission  of any measure which  impedes  the  free  circulation  of  a type  of  product 
or  model  of  a  product  which  is  legally  produced  or  marketed  in  another  Member 
State,  subject  to  the  conditions  laid  down  in  the  decision.  The  progressive 
implementation of this new procedure is providing the Commission with a much more 
accurate over-view of the true situation within the internal market,  enabling it to  take 
appropriate remedial action where necessary. 

The Commission would  invite comments  on the free movement  of foodstuffs  in non-
harmonized  areas,  and  particularly  on  whether  the  principles  described  above  have 
been fully  implemented  at national level, and are still valid. 

56 

PART VI 

THE EXTERNAL DIMENSION 

1.  General  considerations 

The  effects  of the  Community's  food  legislation  are  not  confined  to  the  Community 
alone. In accordance with the EEA agreement,  Community food  legislation is applied 
in Norway  and  Iceland,  and  it will  shortly  be  applied  in Liechtenstein.  T\\e applicant 
countries  in  central  and  eastern  Europe  and  Cyprus  are  in  the  process  of  adjusting 
their  legislation  to  apply  Community  rules  in  preparation  for  their  accession  to  the 
Community.  The  customs  union  agreement  between  the  Community  and  Turkey 
provides  for  the  harmonization  of  legislation,  legislation  and  negotiations  with 
Switzerland  are also at an advanced  stage. A number of other third  countries are also 
using  Community  legislation,  which  often  closely  reflects  the  relevant  international 
standards established by Codex Alimentarius, as a model for their own legislation. 

The principles of the internal market  also apply to goods from non-member  countries 
which  have  been  put  into  free  circulation.  Such  products  must  meet  all  the 
requirements  which  are  laid  down  in  Community  legislation  for  products  produced 
within  the  Community.  For  foodstuffs  of  animal  or  plant  origin,  there  are  specific 
veterinary  and  phytosanitary  inspection  and  certification  procedures  which  are 
undertaken  at the point of entry into the Community,  and specific  controls relating to 
quality  standards  for  unprocessed  fruits  and  vegetables  for  export  and  import.  The 
Community also carries out inspections in non-Community countries. 

In  other  cases,  there  are  no  special  procedures  for  the  inspection  or  certification  of 
imports  and  exports.  Controls  on products  are undertaken  on  a random  basis,  at  the 
point  of entry,  or  at the point  of destination,  and the  activities  of importers  may also 
be  subject  to  control.  Consideration  may  need  to  be  given  to  better  coordination  of 
controls  on  imports.  It  is  also  worth  recalling  that  foodstuffs  are  part  of  the  list  of 
products  which  are  more  specifically  covered  by  controls  performed  under  Council 
Regulation  (EEC)  339/93  on checks  for  conformity  with the  rules  on  product  safety 
in the case of products imported from third countries. 

In  addition,  to  being  a  major  food  importer,  the  Community  is  also  a  major  food 
exporter.  Indeed  it  is  estimated  that  in  1996  the  Community  will  have  a  favourable 
trade  balance  in excess  of ECU  10,000  million  in food  and  drink  products.  In  these 
circumstances, it is important  to  ensure that the Community's own internal  legislation 
provides  adequate  reassurances  for  our  major  trading  partners,  and  that  our  exports 
do  not  encounter  unjustified  restrictions  in  gaining  access  to  markets  outside  of  the 
Community. 

5 7-

Recent years have seen important changes in the multilateral trading system applicable 
to  foodstuffs,  and in the bilateral  relationships between the Community  and  its  major 
trading partners. 

2. 

The multilateral  dimension 

Both  the  recent  changes  introduced  by the  WTO  Agreements  and  those  relating  to 
the Codex Alimentarius have an impact on food law. 

* 

2.1  The WTO  Agreements 

Several  of  the  agreements  concluded  at  the  end  of  the  Uruguay  round  have  had 
important  effects  on the  foodstuffs  sector.  The  Agreement  on  Agriculture  is  having 
significant  effects  on  the  conditions  of  international  trade  in  foodstuffs.  The 
implementation  of the Agreement  on Trade-Related  Aspects  of Intellectual  Property 
Rights  will  facilitate  the  international  recognition  of  denominations  of  origin  and 
certificates  of  specificity  which  have  been  granted  in  accordance  with  the  relevant 
Community  regulations.  However,  it  is  the  amendment  of  the  Agreement  on 
Technical  Barriers  to  Trade  (TBT)  and  the  new  Agreement  on  Sanitary  and 
Phytosanitary  Measures  (SPS) which will  have the most  important  consequences  for 
Community foodstuffs  legislation. 

These two Agreements are designed to prevent technical legislation which is intended 
for the protection of the human health or safety,  the protection  of the health or life  of 
humans  animals  or  plants,  consumer  protection  against  deceptive  practices  and 
environmental  protection  being  used  to  create  or  resulting  in  unjustified  barriers  to 
international  trade.  The  Community  is  a  full  party  to  both  agreements,  which 
therefore  apply  both  to  Community  legislation  and  to  legislation  adopted  by  the 
Member  States. 

The Agreements  encourage WTO members to participate fully  in the  development  of 
harmonised  international  standards  with  a  view  to  reducing  the  barriers  to  trade 
arising from conflicting  national rules. If a member observes the  standards,  guidelines 
and  recommendations  prepared  by  the  relevant  international  organizations  when 
adopting  a  measure,  the  measure  in  question  is  presumed  to  comply  with  the 
provisions of the Agreements. However,  both Agreements  also recognise the right of 
members,  as  Sovereign  entities,  to  lay down  measures  which  provide  a  greater  level 
of protection  than that  provided  for by the relevant  international  standards,  providing 
that these measures do not result in unjustifiable  restrictions on international trade. 

58 

In  order  to  encourage  transparency,,  both  Agreements  provide  for  the  prior 
notification  of  draft  measures  which  could  affect  international  trade,  thus  giving  the 
other WTO members an opportunity to comment on them. 

The  TBT  Agreement  applies  to  all  products,  including  agricultural  products,  and 
covers  all  measures  which  could  affect  international  trade.  It  does  not,  however, 
apply to sanitary and phytosanitary measures as defined  in the SPS Agreement. 

In  order to  achieve its  objectives,  the  Agreement  lays  down  a number  of principles: 
the  measures  of  the  contracting  countries  should  have  a  legitimate  objective;  the 
measures  adopted  should  be  appropriate  or  proportionate  to  those  objectives,  there 
should  be no  alternatives which  cause less disruption to  international  trade  and  there 
should be no discrimination. 

In the food  sector, the aims which, under the TBT Agreement,  might justify  measures 
taken  by a  contracting  party which  diverge from the  relevant  international  standards 
include:  prevention  of practices which might be misleading (misleading  information), 
protection  of  human  health  or  safety,  protection  of  animal  life  or  health,  and 
protection of the environment. 

Justification  for  measures  taken  to  achieve  these  legitimate  objectives  might  include 
scientific  and technical data, related processing methods or the end-use of products. 

The SPS Agreement  applies to measures; 

to  protect  animal  or  plant  life  or  health  from  risks  arising  from  the  entry, 
establishment  or  spread  of  pests,  diseases,  disease-carrying  organisms  or 
disease-causing organisms; 
to  protect  human  or  animal  life  or  health  from  risks  arising  from  additives, 
contaminants, toxins or disease-causing organisms in foods; 
to  protect  human  life  or  health  from  risks  arising  from  diseases  carried  by 
animals,  plants  or  products  thereof,  or from the  entry,  establishment  or  spread 
of pests; 
to  prevent  or  limit  other  damage  from  the  entry,  establishment  or  spread  of 
pests. 

The basic aim of the SPS Agreement is to maintain the sovereign right of any member 
to provide the level of health protection  it deems appropriate, but to  ensure that these 
sovereign  rights  are  not  misused  for  protectionist  purposes  and  do  not  result  in 
unnecessary barriers to international trade. 

-59 

The measures which members adopt to achieve their chosen level  of protection must 
be based  on an assessment  of risks to health, taking  into  account  available  scientific 
evidence,  processes  and  production  methods,  inspection,  sampling  and  testing 
methods  and,  in  the  case  of  animal  and  plant  life  and  health,  relevant  economic 
factors. 

Measures  must  not  arbitrarily  or unjustifiably  discriminate  between  members where 
identical  or similar conditions  prevail.  They must  be  not  more  trade-restrictive than 
required to  achieve the appropriate level  of protection,  taking into  account technical 
and economic feasibility. Members may introduce or maintain measures which result 
in  a  higher  level  of  protection  than  would  be  achieved  by  measures  based  on 
international  standards,  guidelines  or  recommendations  -if  there  is  a  scientific 
justification or as a consequence of the level of protection the member  determines to 
be appropriate. 

Unlike  the  TBT  Agreement,  the  SPS  Agreement  refers  specifically  to  some  of  the 
international  organizations  whose  standards,  guidelines  and  recommendations  it 
considers  to  be  relevant.  These  are,  for  food  safety  the  Codex  Alimentarius 
Commission,  for  animal  health  and zoonoses  the  International  Office  of  Epizootics 
and for plant health the International Plant Protection Convention. 

WTO  members  failing  to  comply  with  the  relevant  international  standards  may  be 
challenged in several ways: 

WTO Members  considering  that the  national  measures  notified  to  them under 
the notification procedures conflict with the SPS and TBT Agreements may ask 
for justification; 

the  national  measures  may  be  brought  before  the  committees  responsible  for 
managing the  Agreements;  for  example the  SPS  Agreement  states  that  in the 
case of legislation having a major impact on international trade, a list of which is 
to  be drawn up by the management  committee,  a Member which fails to apply 
an international standard will have to explain its reasons to the committee; 

disputes  may be  settled  by  special  panels  set  up  within  the  framework  of  the 
WTO. 

2.2  Developments within the Codex Alimentarius 

In  1962  the Food  and Agriculture  Organization  and the World  Health  Organization 
set up a joint FAO/WHO committee on the Codex Alimentarius to prepare standards, 
recommendations and guidelines with a view to protecting consumer health, ensuring 
fair  trading  practices  and  facilitating  international  trade.  By  1994,  Codex  had  146 
member  countries.  It  had  established  237  commodity  food  standards,  41  codes  of 

60 

practice  covering  hygiene  and  food  technology.  185  pesticides  had  been  evaluated 
leading to the establishment  of 3,274 maximum residue limits for  pesticides. 760  food 
additives  and  25  contaminants  had  also  been  evaluated  together  with  54  veterinary 
drugs. 

In March  1991  a  conference  on  food  standards,  chemicals  in  food  and  international 
trade  organized  by the FAO  and  the WHO,  in cooperation  with  GATT,  built  on  the 
experience gained by GATT to plan future  progress on the Codex Alimentarius  and a 
new SPS Agreement. 

The  SPS  Agreement  gives 
the  standards, 
recommendations,  guidelines  and  codes  of  good  hygiene  practice  adopted  by  the 
Codex. 

international  reference  status 

to 

The Codex  has  started  a radical  overhaul  of its approaches  and  procedures  so that  it 
can perform  the  role  assigned  to  it under  the  SPS.  This  has  resulted  in  a number  of 
reforms  to improve the efficiency  of procedures for preparing and adopting standards. 
In  addition,  the  content  of  a  large  number  of  Codex  standards  is being  reviewed  to 
take account  of the new WTO Agreements. However,  the relationship  of Codex with 
the SPS Agreement needs to be clarified  and refined  further. 

in  devising  and 
The  Community  is  determined 
implementing  these new  approaches,  and to  seek a high level of health  and  consumer 
protection,  and must make sure it has the necessary resources to do this. 

to  play  a  constructive  part 

2.3  The consequences  of these developments  for  the  Community 

These  developments  have  several  consequences  for  Community  activities  in the  food 
sector. 

1. 

2. 

The  Community  will  increasingly  be  required  to  provide  scientific  justification 
for  its measures  at  international  level.  The  suggestions  set  out  above  for  prior 
consultation  of  scientific  committees  should  also  be  considered  as  proposals  in 
connection with changes required of the Community at international level. 

Since  the  Community  must  be able to justify  measures  which  diverge  from  the 
relevant  international  standards,  it  is  important  to  take  account  of  the 
international  dimension  in  the  Community's  scientific  assessment  work.  The 
members  of  Community  scientific  committees  must  be  able  to  cooperate  with 
international 
their  other  colleagues,  particularly  within 
committees  of  scientific  experts  like  the  Joint  Expert  Committee  on  Food 
Additives (JECFA) and the Joint Meeting on Pesticide Residues  (JMPR), which 
are  responsible  for  preparing  the  scientific  assessments  of  hazards  which  form 
the scientific basis for preparation of Codex standards. International  assessments 
of  specific  hazards  should,  where  they  exist,  be  taken  into  account  as  far  as 
possible, without,  however compromising the Community's level of protection. 

the  context  of 

61 

3. 

4. 
' 

The new  situation  provides  the  Community  not  only with  a challenge,  but  also 
with an opportunity to  ensure that new measures  adopted  by our  major  trading 
partners  are  also  in accordance with  their  international  obligations.  In  order  to 
take the best advantage of this opportunity, the Community must be prepared  to 
mobilise the resources  necessary to  scrutinise the  measures  which  are  prepared 
by our  trading  partners.  This can  only be  achieved  through  a  close  partnership 
between the Commission, Member  States and those whose interests  are directly 
at stake, in particular Community producers and industry. 

The  Community  must  also  be  capable  of  playing  a  full  role  during  the 
negotiations  within  Codex  Alimentarius  and  other  fora  which  lead  to  the 
standards.  Full  Community 
international 
adoption  and  acceptance  of 
participation is essential in order to  ensure that the Community  interest  is taken 
into  consideration  during  the  preparation  of  international  standards  which  will 
be used  as a reference  point for judging the legitimacy  of the Community's  own 
legislation.  The  current  situation  where  the  Community  is  a  full  party  to  the 
WTO  agreements,  but  is  accorded  only  the  status  of  an  observer  during  the 
elaboration  of  international  standards  by  Codex,  constitutes  an  unacceptable 
anomaly,  which  must  be  remedied  as  soon  as  possible  by  the  accession  of  the 
Community to full  membership of Codex Alimentarius. A proposal to this  effect 
has  been  presented  to  the  Council;  the  latter  has  granted  the  Commission  a 
mandate and negotiations have begun with the Codex  Secretariat. 

Likewise,  given  the  competences  of  the  Community  in  the  field  of  plant 
protection,  and  taking  account  of  the  objectives  of  the  International  Plant 
Protection  Convention  (IPPC),  the  Community  is participating  in the  review  of 
the IPPC and intends subsequently to adhere to it. 

As  a  corollary,  Community  participation  in  international  scientific  efforts  to 
assess  existing  hazards  should  be  increased.  Directive  93/5/EEC  on  scientific 
cooperation  already  provides  the  basis  for  Community  bodies  to  take  part  in 
international  scientific  cooperation.  The  proposal  for  a  5th  framework 
programme also foresees  such reinforced  participation. 

3. 

The bilateral  dimension 

Developments  at  global  level  also  provide  a  general  framework  within  which 
individual  countries may also  sign their own bilateral  equivalence  agreements.  Article 
4  of  the  SPS  Agreement  encourages  the  development  of  bilateral  equivalence 
agreements,  and  the  Codex  Alimentarius  Committee  on  Food  Import/Export 
Certification  and  Inspection  Systems  is  also  preparing  guidelines  to  encourage  the 
development  of bilateral  agreements.  These  agreements  make  it  possible  to  evaluate 
in  practical  terms  those  sectors  where  the  regulations  and  guarantees  provided  by 
official  inspection  and  certification  schemes  are recognized  as equivalent,  i.e.  which, 
although  they  may  be  different,  are  considered  to  provide  the  same  level  of 
protection.  Recognition  of  equivalence  helps  facilitate  trade  by  simplifying  the 
conditions of trade between the signatory countries. 

62 

Such  agreements  are particularly  necessary  when  systems  of  legislation  are based  on 
the  implementation  during production  or  processing  of  prevention  measures  such  as 
those  based  on  HACCP  principles.  Proof  that  the  system  is  being  applied  can  be 
provided  only by carrying out inspections in the companies themselves  and not  solely 
by inspecting the finished product. 

These agreements also make it possible to manage public official  inspection  resources 
more  efficiently  without  reducing  the  level  of  consumer  protection  by  avoiding 
unnecessary  repetition  of  inspections  which  have  been  properly  carried  out  by  the 
exporting  country.  In  addition,  they  could  facilitate  technical  cooperation  between 
various  countries  in  the  area  of  scientific  research,  and  the  preparation  of  food 
regulations, and controls and  certification. 

In this context,  it should be recalled that  on 21  September  1992 the  Council  adopted 
a  Decision  authorizing  the  Commission  to  negotiate  agreements  between  the 
Community  and  certain non-member  countries  on  mutual  recognition  with  a view  to 
conformity  assessment. 
In  addition,  on  the  basis  of  other  Council  mandates,  the 
Commission  has  opened  negotiations  with  a  view  to  bilateral  veterinary  and 
phytosanitary  equivalence  agreements.  An  agreement  with  New  Zealand  has  been 
agreed  by  the  Council  and  signed.  A  proposal  for  an  agreement  with  the  Czech 
Republic  has  been  completed  and  submitted  to  the  Council.  Negotiations  are 
including  Australia,  Canada  and  the  United 
continuing  with  other  trading  partners, 
States; South American countries, in particular Argentina,  Chile and Uruguay  and  the 
associated  countries of Central and Eastern Europe. 

equivalence  agreements  outside  the 
In  order  to  facilitate  the  development  of 
veterinary  and phytosanitary  sectors, consideration  should be given to  completing  the 
existing provisions on official  control with measures designed to: 

ensure  that  inspections  of  imported  and  exported  products  comply  with 
international  rules,  particularly  by taking  account  of  proportionality  in  relation 
to hazards as proposed  above and allowing  agreements recognizing  equivalence 
to be taken into consideration; 

allow  the  specific  team  of  Community  officials  responsible  for  assessing  and 
checking  the  equivalence  and  effectiveness  of  official  food  control  systems  in 
Member  States  as  referred  to  in  Directive 93/99/EEC  also  to  cooperate  with 
Member  States  in assessing  and  inspecting  the  official  control  systems  of  non-
member  countries  within  the  framework  of  negotiating  and  managing  an 
agreement recognizing equivalence. 

In  addition,  the  Community  maintains  a  variety  of  bilateral  contacts  with  its  major 
trading  partners  on regulatory  issues relating to  the food  sector,  including  the Trans-
Atlantic Dialogue, and regulatory  cooperation. 

63 

ISSN 0254-1475 

COM(97)  176 final 

DOCUMENTS 

EN 

03  06  01  10 

Catalogue  number  :  CB-CO-97-196-EN-C 

ISBN 92-78-19509-X 

Office  for  Official  Publications  of the European  Communities 

L-2985  Luxembourg