PROPOSAL FOR A COUNCIL DIRECTIVE ON ASSISTANCE TO THE COMMISSION AND COOPERATION BY THE MEMBER STATES IN THE SCIENTIFIC EXAMINATION OF QUESTIONS RELATING TO FOOD
Date: 1991-04-03
Institutions: European Commission
Subjects: consumer survey, cooperation policy, human nutrition, public health, scientific cooperation, standing committee (EU)

COMMISSION OF THE EUROPEAN  COMMUNITIES 

C0M(91) 16 final - SYN 332 

Brussels, 3 April  1991 

Proposal  for a 

COUNCIL DIRECTIVE 

on assistance  to the Commission  and cooperation by the 

Member  States  in the scientific examination of  questions 

relating to food 

(presented by the Commission) 

-  2 -

EXPLANATORY  MEMORANDUM 

1. 

In  its  1985  Communication  on  Food  Law1  the  Commission  announced  a 

policy  for  the completion  of  the  internal  market  in the  food  sector. 

This 

policy  envisaged  the  adoption  by  the  Council  of  a  number  of  framework 

Directives  to  deal  with  those  essential  questions  for  which  Member  States 

could  still  invoke  Article  36 of  the  Treaty  and  for  which  common  measures 

are  needed  to  complete  the  single  market  without  frontiers. 

These 

questions  are  those  which  concern  Public  Health,  Fair  Trading  and  Public 

Controls. 

2. 

The  Commission  also  envisaged  that  the  laying  down  of  detailed 

measures  would  be  entrusted  to  the  Commission,  and  to  a  large  extent  the 

Council  has  concurred  with  this  approach.  Only  in  the  additives  Directive 

has  the Council  retained  for  itself  the power  to adopt  detailed  rules, but 

even  in  this  case  it  is  clear  that  the  technical  preparation  of  the 

proposals must  be carried out  by  the  Commission. 

3. 

In  1974  the  Commission  created  a  Scientific  Committee  for  Food  (SCF) 

to advise  it on  questions of  food  safety  and  this Committee  has  proved  its 

worth  as  an  independent  arbiter  of  food  safety  questions,  gaining 

international  recognition. 

In a  number  of  the  framework  directives,  such 

as  additives,  materials  in  contact  with  foodstuffs,  food  solvents, 

flavourings  and  dietary  products,  the  Council  requires  the  opinion  of  the 

Committee  to be given when  questions of  health  are  involved. 

Other  health  questions  relating  to  food,  such  as  questions  of  food 

microbiology  and  the use of  biotechnology  in the production  and  manufacture 

of  food, will  require opinions  from  the  Committee. 

These  new  demands  placed  on  the  Committee  are  not  sustainable  by  the 

present  administrative  arrangements,  resources  and  infrastructure. 

1 COM(85) 603  final. 

-  3 -

4. 

In  the  Member  States  tasks  equivalent  to  those  undertaken  by  the 

Scientific  Committee  for  Food  are  carried  out  by  similar  national  advisory 

bodies, 

designated 

research 

institutes 

or 

specialist 

government 

departments. 

Since,  under  new  Community  legislation,  assessments  at 

national  level  will  only  lead  to  temporary  authorizations,  considerable 

economies  can  be  achieved  by  using  the  available  national  resources  in a 

coordinated  manner  to  carry  out  those  Community  scientific  assessments 

which  will  replace national  assessments  in food  law. 

5. 

The  procedure of  petitioning  the Commission  directly  for  an  assessment 

will  necessitate  a  new  administrative  documentary  system  for  receiving, 

registering,  carrying  out  preliminary  verifications,  and  distributing 

documents  to  the  assessing  bodies  participating  in  the  cooperative 

assessment. 

Records  must  be  held  and  the  Commission  has  agreed  that 

wherever  possible  these  will  be  accessible  to  the  public. 

The 

preparation,  translation  and  publication  of  SCF  opinions  will  also  require 

increased  resources. 

6. 

For  ten  years  the  Commission  has  been  operating  an  alert  system  for 

food  contamination. 

This  has  handled  many  hundreds  of  cases  and  was  of 

particular  value  in  dealing  with  the  wine  contamination  scandals  and 

Chernobyl. 

The  removal  of  internal  frontier  controls  and  the  increased 

movement  of  goods  within  the  Community  will  place  greater  demands  on  this 

system,  necessitating  a  reinforcement  of  both  information  handling  and 

scientific  and  technical  assessment  infrastructure,  in order  that  opinions 

may  be  delivered  immediately,  which  will  sometimes  mean  emergency 

consultation of  the SCF. 

7. 

The  Directive on  public  controls2  lays down  a number  of  operations at 

Community  level  which  may  very  well  give  rise  to  a  number  of  questions 

requiring  scientific  appreciation. 

2 Directive 89/397/EEC, OJ  No L  186, 30.6.1989, p. 23. 

-  4 -

8. 

The  pre-legislative  assessment  of  safety  and  nutritional  aspects  can 

only  be  made  on  the  basis  of  sound  and  consistent  data  on  nutrition  and 

food  intake  throughout  the  Community. 

Ongoing  coordination  of  national 

food  intake  surveys  needs  to  be  established  and  the  results  analysed  to 

provide  basic scientific  information  for  legislation. 

9. 

National  situation 

Public  and  government  concern  with  food  safety  and  nutrition  has  been 

increasing  in recent  years. 

At  national  level, there  have been  calls  from 

consumers  to  set  up  an  independent  body  which  would  be  the  guardian  of 

public  health  and  nutrition. 

Some  examples  of  the  way  in  which  these  questions  are  dealt  with  are  as 

fol lows: 

(a)  The  United  Kingdom  decided  in  October  1989  to  concentrate  all  food 

safety  questions  in one department  of  the Ministry  of  Agriculture, and 

there  is  direct  consumer  involvement.  The  government  also  has 

recourse  to the advice of  a number  of  independent  committees: 

-  The Committee  on Toxicology  (COT) for  safety  questions 

-  The Committee on Medical  Aspects of  food  (COMA) 

-  The Committee on Microbiology  in foods 

-  Two  new  committees  dealing  with  novel  foods  and  novel  food 

processes. 

The  UK  Food  Advisory  Committee  is  consulted  by  the  government  on 

questions of  proposed  legislation or  concern  in the  food  sector. 

-  5 -

(b)  In  France  and  Belgium  the  government  consults  the  Conseil  Supérieur 

d'Hygiène  Publique,  which  is similar  to  the  Scientific  Committee  for 

Food  in  that  it  is  made  up  of  highly  qualified  scientists.  This 

Committee  has  a number  of  sections - to deal  with  the  various  aspects 

of  food, e.g.  hygiene, nutrition, etc. 

(c)  In Germany  the  government  has  entrusted  all  questions  of  food  safety 

to  the  "Max  Von  Pettenkofer-Institut  des  Bundesgesundheitsamtes"  in 

Berlin, which  enjoys considerable  scientific  resources. 

(d)  In  Italy  the government  obtains  scientific  expertise  from  the  Istituto 

Super lore di  SanIta, which  also has  its own  assessment  resources. 

10.  The  European  Parliament 

(a)  The  report  on  the  food  industry  drawn  up  by  MEP  Raftery  in  the 

Committee  on  Economic  and  Monetary  Affairs  and  Industrial  Policy  and 

adopted  by  the  Parliament  in April  1989  notes  that  the  Commission  is 

gaining  new  delegated  responsibilities  and  considers  that  it  is 

essential  to  ensure  that  the  Commission  and  the  Scientific  Committee 

for  Food  are  given  sufficient  resources  to  undertake  their  new 

functions  in an  open  and  transparent  manner,  while  keeping  secrecy  to 

a  minimum,  and  that  the  European  Parliament  should  be  kept  fully 

informed of  the use of  the new powers. 

The  report  concludes  that  the  Commission  should  consider  the 

establishment  of  a  new  Food  Law  Unit  which  would  help  the  Commission 

carry  out  its  new  tasks.  The  report  asks  the  Commission  to  make 

proposals within  six months. 

(b)  Reports  by  MEPs  Albert3,  Collins4  and  Pimenta5  all  call  on  the 

Commission  to  consider  strengthening  its resources  in  respect  of  food 

safety. 

3 PE  130.366/Fln 

4  PE  130.073/Fln 

5 PE 

/Fin 

-  6 -

11.  Position of Member  States 

On  15  and  16  June  1989,  at  a  meeting  of  senior  officials  specializing  in 

food  law,  the  representatives of  the Member  States  agreed  that  in view  of 

the  new  situation  created  by  the  adoption  of  the  various  food  framework 

directives  there  was  a  need  to  pool  national  and  Community  resources  and 

set  up  a  new  procedure  for  scientific  evaluation. 

On  13 November  1989  a 

further  meeting  was  held  at  which  the  elements  of  a  procedure  for 

collaborative  evaluation  were  drawn  up.  The  essential  elements  of  this 

scheme were as  follows: 

-  the  detailed  work  of  evaluation  would  be  carried  out  by  national  bodies, 

which would  prepare  a monograph  on  the matter  under  consideration; 

-  the  Scientific  Committee  for  Food  rapporteur  dealing  with  a  particular 

topic and  the evaluating  body would  be  from different  Member  States; 

-  the Commission's  SCF  secretariat  would manage  the day-to-day  distribution 

of evaluation  files and  all  questions of general  documentation; 

-  the  operation  of  the  collaborative  scheme  would  be  overseen  by  the 

Standing  Committee  for  Food,  paying  particular  attention  to  priorities, 

the balance of work  and  resources; 

- Member  States would  provide  the resources  for  the detailed  evaluation  and 

the Commission  would  seek  resources  to finance  the cooperative  element; 

- specialist  staff  should  be  seconded  to  the  SCF  secretariat  from  national 

institutions or other  appropriate bodies. 

-  7  -

The  cooperative  scheme  should  not  only  deal  with  assessments  which  are 

necessary  for  legislation,  but  could  be  consulted  on  any  questions 

relating  to  food which  have  an element  of  scientific  assessment  and  would 

also cooperate on matters  such  as  food  intake  surveys  required  as a basis 

for  food  safety  and  nutritional  assessment. 

12.  Position of  consumers 

European  consumer  organizations  have  in  general  strongly  supported  the 

Commission's  efforts  towards  providing  mandatory  legislation  on  questions 

relating  to  health  and  safety  and  consumer  information. 

They  would  also 

like  questions  relating  to  food  safety,  which  are  a  cause  of  legitimate 

concern  to consumers,  to be  dealt  with  rapidly  and  efficiently. 

13.  Position of  industry 

European  Industry  and  commerce  realize  that  there  is  little  likelihood  that 

the  important  regulatory  decisions,  on  which  depend  the  realization  of  a 

single market  for  foodstuffs, will  be  taken  in time unless  the  arrangements 

for  the organization  of  the  necessary  underlying  scientific  evaluation  are 

significantly  Improved  and  streamlined. 

They  believe  that  given  the 

present  arrangements  it  will  not  be  possible  to  meet  the  need  for  any 

timeframe  which  would  be  considered  commercially  relevant  for  technical 

evaluations  in  the  field  of  additives,  new  foods,  dietetic  foods,  or 

materials  in  contact. 

They  are  also  concerned  that  questions  of  safety 

should  be  effectively  and  expeditiously  dealt  with  to  meet  legitimate 

consumer  concerns. 

-  8 -

14.  Basis  for  a solution 

The  principal  role  of  the  Commission  hitherto  has  been  that  of  policy 

formation  and  the  preparation  of  legislative  initiatives. 

The  new 

decisions of  the Council  in the  field of  food  law confer  on  the  Commission 

not  only  the  execution  and  Implementation  of  many  legislative  acts  but  an 

obligation  to  consult  the  Scientific  Committee  for  Food  on  questions  of 

health. 

There  is, therefore,  a mandatory  requirement  in Community  law  to 

provide  the  means  to  execute  these  tasks  of  scientific  assessment  and 

support  for  the  legislative  function  and  to  deal  with  similar  tasks 

necessary  to the proper  functioning  and development  of  the common market  in 

food. 

The considerable  progress achieved  lends urgency  to the situation  since all 

those  concerned  are now  turning  directly  to  the Commission  to  fulfil  those 

tasks  previously  carried  out  at  national  level. 

This  proposal  will  also 

result  in considerable  savings  in national  resources  by  avoiding  multiple 

assessments  being  carried  out  where  applications  are made  through  national 

authorities. 

12) 

-  9  -

Since  the  Scientific  Committee  has  no  scientific  support  staff,  scientific 

bodies  in  the  Member  States  will  be  asked  to  carry  out  the  detailed 

assessments  necessary  for  compiling  monographs  and  similar  synoptic 

documents,  on  the  basis  of  which  the  Scientific  Committee  for  Food  will 

deliver  Its  opinions.  The  preparation  of  each  document  will  generally 

require  several  weeks  of  work  by  the  scientific  personnel  of  the  national 

assessment  bodies,  in collaboration with  a  relatively  small  Commission  team 

responsible  for  coordinating  the  work  and  assisting  the  Commission  in  its 

various  activities.  This  solution  would  obviate  the  need  to  set  up  an 

agency.  Instead  of  setting  up  a structure within  the Commission  capable  of 

carrying  out  the  necessary  assessments,  recourse  will  be  had  to  existing 

facilities  in  the  Member  States.  Thus  the  principle  of  subsidiarity  will 

mean major  savings  in terms of  personnel. 

This  will  also  enable  the  Community  better  to  fulfil  its  international 

obligations,  which  are  being  increased  by  the  realization  of  the  internal 

market  and  the  probable  creation  of  an  international  mechanism  for  solving 

questions  of  food  safety  within  the  framework  of  the WHO/FAO  Codex  and  the 

GATT  during  the Uruguay  Round. 

Since  some  of  our  trading  partners  do  not  necessarily  have  the  scientific 

expertise  of  the  Community,  it  should  be  possible  for  the  Commission  to 

negotiate  participation  by  third  countries  and  their  contribution  to 

scientific  evaluation  of  food  questions,  if both  parties  consider  it  to  be 

desirable. 

it  is  considered  that  the  functions  which  need  to  be  carried  out  in  this 

sector  can  best  be  undertaken  by  the  cooperation  system  put  forward  in  the 

accompanying  proposal,  which  responds  to  the  request  of  the  European 

Parliament  on  this  question,  as  expressed  in  the  resolution  accompanying 

the Raftery  report. 

The  appropriations  needed  for  this  action  will  be  determined  by  the  annual 

budgetary  procedure.  They  will  be  covered  by  the  ordinary  development  of 

Articles B5-3000 and  B8-530 which  must  take account  both  of  the  constraints 

imposed  by  the  ceiling  in heading  4  of  the  financial  perspective  and  of  a 

detailed  examination  of  the  other  priorities  to  be  financed  by  these 

Art icles. 

-  10 -

Proposal  for a 
COUNCIL DIRECTIVE 

on assistance to the Commission and cooperation by the 

Member States  in the scientific examination of questions 

relating to food 

THE COUNCIL OF THE EUROPEAN COMMUNITIES, 

Having  regard  to  the Treaty  establishing  the European  Economic  Community, 

and  in particular  Article 100a thereof, 

Having regard to the proposal  from the Commission,1 

In cooperation with the European Parliament,2 

Having regard  to the opinion of the Economic and Social  Committee,3 

Whereas  the  completion  and  smooth  operation  of  the  internal  market  for 

foodstuffs make  it necessary  to examine  and evaluate  scientific  questions 

relating  to  food  in disciplines  such  as  medicine,  nutrition,  toxicology, 

food contamination, microbiology, biotechnology and chemistry, particularly 

when these questions concern human health; 

Whereas  in  order  to  assist  with  this  task  the  Commission  set  up  a 

Scientific Committee for Food by Decision 74/234/EEC;4 

Whereas  consultation  of  this Committee  is currently  required,  in  relation 

to questions of  public  health, by  a number  of  Directives  such  as  those on 

dietetic  foodstuffs, materials  and  articles  intended  to come  into  contact 

with foodstuffs, additives, flavourings and extraction solvents; 

Whereas  in  order  to  ensure  the  smooth  running  of  this  Committee  the 

Commission needs scientific support  from the Member States; 

1 

2 

3 

4 

0J No L 136, 20.5.1974, p. 1. 

-  11  -

Whereas  the  Commission  also  needs  scientific  and  logistical  support  for 

other  questions  of  public  interest  essential  to  the  operation  of  the 

internal  market,  such  as  the  handling  of  incidents  involving  food 

contamination  and  public  controls  and  in general  where  it  is necessary  to 

lay down  new  rules concerning  foodstuffs  which  may  affect  human  health; 

Whereas,  in  order  to  ensure  that  these  tasks  are  carried  out,  the 

Commission  must  have  access  to  the  information  and  assistance  available  in 

the Member  States, which must  facilitate  the accomplishment  of  its work; 

Whereas  the  completion  of  the  internal  market  is giving  rise  to  increased 

participation  of  the  Community  represented  by  the  Commission  in  the 

meetings  and  work  on  foodstuffs  of  international  organizations  such  as  the 

WHO,  FAO,  JECFA,  GATT,  Council  of  Europe,  OECD  and  also  in  bilateral 

relations; 

Whereas  in  the  Member  States  there  are  various  institutions  whose  task  is 

to  provide  their  governments  with  scientific  back-up  on  questions 

concerning  foodstuffs;  whereas  it  is  necessary  to  use  these  resources 

effectively  to support  Community  activities  through  cooperation; 

Whereas  there  must  therefore  be  an  approximation  of  the  provisions 

governing  these  bodies  in order  that  they  may  cooperate  directly  with  the 

Commission  with  the aim  especially  of  drawing  up  future  rules  to ensure  the 

free  movement  of  foodstuffs,  on  the  basis  of  all  the  scientific  data 

aval table; 

Whereas  it  is  necessary  to  make  provision  for  third  countries  to 

participate  in this  cooperation; 

Whereas  the  Commission  must  be  responsible  for  the  management  of  this 

cooperation  and  the Member  States  for  their  part  must  assist  In  this  task, 

in the context  of  the Standing  Committee  for  Food, 

HAS ADOPTED  THIS  DIRECTIVE: 

-  12  -

Article 1 

Member  States  shall  take  the  necessary  measures  to  adapt  the  laws, 

regulations  and  administrative  provisions which  govern,  in particular, 

the  functioning  of  their  competent  authorities  and  bodies  so  as  to 

enable  them  to  cooperate  with  the  Commission  and  lend  it  the 

ass(stance  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  medicine,  toxicology,  biology, 

microbiology,  nutrition, physics  and  chemistry. 

This  Directive  shall  apply  when  a Council  act  requires  the  opinion  of 

the Scientific  Committee  for  Food. 

This  Directive  shall  also  apply  in  all  cases  where  scientific 

appraisal  of  questions  of  public  interest  in  the  field  of  the  free 

movement  of  foodstuffs  proves  necessary  and  particularly  where  there 

is a risk  to public  health. 

Article  2 

1. 

Member  States  shall  designate  the  authorities  or  bodies  which  will 

cooperate  with  the  Commission  by  performing  the  tasks  laid  down  in 

Article  3 and  shall  notify  the Commission  accordingly. 

-  13 

Article  3 

1. 

The  principal  tasks  to be carried out  by  the designated  authorities or 

bodies  participating  in the  cooperation  are  listed  in Annex  I. 

2. 

The  following  measures  shall  be  executed  in  accordance  with  the 

procedure  laid down  In Article  5: 

-  establishment  of  programmes  of  work  for  fixed  periods  in  the  areas 

of  activity  listed  in Annex  I; 

-  establishment  of  rules  for  the  administrative  management  of  the 

cooperation; 

-  establishment  of  rules  for  the  appraisal  of  requests  for  scientific 

assessment  submitted  to  the  Commission  or  to  Member  States  in 

accordance  with  Council  acts  which  require  the  consultation  of  the 

Scientific  Committee  for  Food-, 

-  for  extensive  studies, deciding  the programme  of  work  to be  carried 

out  and  designating  the  authorities  or  bodies  to  cooperate  in  a 

particular  study. 

3. 

Annex  I may  be  supplemented,  in  accordance  with  the  procedure  laid 

down  in Article  5,  to  include  other  areas  of  activity  relating  to  the 

object  of  this  Directive. 

-  14 -

Article  4 

The  Commission  is  hereby  authorized  to  open  negotiations  with  a  view  to 

concluding  agreements  with  third  countries  guaranteeing  their  participation 

in the cooperation  procedures  laid  down  in Article 3(2). 

Article  § 

The  Commission  shall  be  assisted  by  the  Standing  Committee  on  Food  set  up 
by Council  Decision  69/414/EEC1. 

The  Commission  representative  shall  submit  to  the  Committee  a  draft  of  the 

measures  to be  taken.  The Committee  shall  deliver  its opinion  on  the  draft 

within  a  time  limit  which  the  chairman  may  lay  down  according  to  the 

urgency  of  the matter,  if necessary  by means of  vote. 

The  opinion  shall  be  recorded  in  the  minutes;  in  addition,  each  Member 

State  shall  have  the  right  to  ask  for  its  position  to  be  recorded  in  the 

minutes. 

The  Commission  shall  take  the  utmost  account  of  the  opinion  delivered  by 

the  Committee.  It  shall  inform  the  Committee  of  the  manner  in  which  its 

opinion  has been  taken  into  account. 

OJ  No L  291, 19.11.1969, p.  9. 

-  15 -

Article  6 

Member  States  shall  bring 

into  force  the  laws,  regulations  and 

administrative  provisions  necessary  to  comply  with  this  Directive  before 

1 January  1993.  They  shall  forthwith  inform  the Commission  thereof. 

When  Member  States  adopt  these  provisions,  these  shall  contain  a  reference 

to  this  Directive or  shall  be  accompanied  by  such  reference  at  the  time of 

their  official  publication.  The  procedure  for  such  reference  shall  be 

adopted  by Member  States. 

Article  7 

This Directive  is addressed  to the Member  States. 

Done at  Brussels, 

For  the Council 

The  President 

-  16 -

ANNEX I 

The  principal  tasks  to  be  carried  out  by  the  designated  authorities  or 

bodies  participating  in the cooperation  shall  include: 

-  drawing  up  risk  assessment  protocols  in  relation  to  food  and  methods 

of  nutritional  evaluation; 

-  examining  test  data  submitted  to  a  Member  State  or  to  the  Commission 

under  the  requirements  of  a  Community  act  and  the  production  of  a 

monograph  for  assessment  by  the Scientific Committee  for  Food; 

-  carrying  out  food  intake surveys, particularly  those  necessary  for  the 

determination or  evaluation  of  the conditions  of  use of  food  additives 

or  the  laying  down of  limit  values  for  other  substances  in  food; 

-  conducting  investigations  relating  to  components  of  diets  or  of 

biological  or  chemical  food  contaminants; 

-  carrying  out  scientific  work  in  relation  to  food  control,  and  in 

particular  that  arising  from  the  programmes  of  official  inspection 

laid  down  under  Directive  89/397/EEC; 

-  collecting  and  storing  data  relating  to  the  abovementioned  activities 

for  assessment  by  official  bodies  or,  where  appropriate,  by  the 

pub lie; 

-  helping 

the 

Commission 

honour 

the 

Community's 

International 

commitments  by  providing  expertise on  food  safety  questions. 

- 17 -

Fiche Financière 

1.  Ligne budgétaire concernée 

B5-300 - Actions communautaires relatives à  l'achèvement  du marché 
Intérieur. 

B8-530 - Dépenses d'appui  et de sout$n aux actions relatives à 
l'achèvement du marché  intérieur. 

2.  Base  Juridique 

Article 100A du Traité. 

3.  Description de  l'action, objectifs, personnes concernées 

Mise en place d'une coopération scientifique entre  les Etats membres 
et  la Commission  afin d'utiliser efficacement  les données 
scientifiques existantes dans  les différents pays de  la CEE concernant 
l'alimentation humaine et ce dans  le cadre de  la procédure  d'adoption 
de  la  législation communautaire en  la matière. 

Cette coopération doit permettre à une équipe de scientifiques 
travaillant  au sein de  la Commission d'obtenir  auprès  d'instituts 
spécialisés au sein des Etats membres des évaluations ou des 
Informations sur des sujets pour  lesquels une disposition  législative 
doit être prise.  L'objectif  principal  de cette coopération est la 
constitution de dossiers servant  de base de discussion pour  le Comité 
Scientifique de  l'Alimentation Humaine qui  doit être consulté  lorsque 
des dispositions sont susceptibles d'avoir  une  incidence sur  la santé 
publique. A titre d'exemple,  il peut être cité  le projet  sur  les 
préparations pour nourrissons. Avant  de pouvoir  fixer des règles de 
composition  concernant  les produits,  Il a été nécessaire d'établir 
quels étalent  les besoins nutrItionnels des nourrissons. Une même 
démarche sera nécessaire pour  les autres catégories de personnes 
soumises à une alimentation particulière. 

4.  Justification de  l'action 

La consultation du Comité Scientifique de  l'Alimentation Humaine est à 
présent  prévue expressément  dans un certain nombre  de directive-cadres 
telles que ce I les relatives aux additifs alimentaires, arômes, 
matériaux  en contact  avec des denrées alimentaires  ....  De 
nombreuses dispositions d'application doivent  être adoptées dans  les 
mois à venir. 

- 18 -

Cette coopération sera également  très utile pour  traiter  des questions 
d'Intérêt  public  liées à  la santé telle que  la contamination des 
aliments ou  le contrôle des denrées alimentaires ainsi  que pour 
participer  à des réunions  Internationales consacrées à ces questions. 

Incidence financière sur  les crédits de personnel  et de fonctionnement 
courant  (partie A du budget) 

La mise en place de cette coopération scientifique permettra de mettre 
en présence quelques milliers de scientifiques travaillant dans les 
organismes compétents des différents Etats membres.  A titre 
d'exemple, La Food and Drug Administration a à sa disposition ± 8000 
personnes pour effectuer  des tâches similaires.  Pour pouvoir d'une 
part mettre en oeuvre  la coopération et d'autre part coordonner  les 
résultats obtenus de  la part des organismes nationaux  (voir  annexe), 
Il est nécessaire de constituer au sein des services de  la Commission 
une équipe restreinte composée de scientifiques de formations diverses 
(toxicologue, nutrItionlste, chimiste, médecin) permettant  de couvrir 
l'ensemble  des secteurs pour  lesquels  la Commission est compétente. 

Cette équipe constitue en fait  le "quartier général" de  l'ensemble de 
l'opération.  Une première analyse a permis d'évaluer  les besoins en 
personnel à 
-  12 fonctionnaires A 
-  1 fonctionnaire C1 
-  3 fonctionnaires C5/C4 
ce qui  représente une économie significative pour  le budget de 
Communautés européennes par rapport  aux autres solutions qui avaient 
été envisagées telle que  la création d'une Agence. 

Afin de confirmer  cette première analyse, un contrat  d'étude a été 
passé en vue d'évaluer  très précisément  les besoins en personnel  et en 
matériel  liés à cette coopération scientifique ainsi  que de mettre en 
place des méthodes efficaces de fonctionnement du secrétariat. 

Les besoins en personnel  sont à satisfaire, soit par redéploiement 
Interne, soit dans  le cadre de  la procédure budgétaire par décision de 
la Commission dans  le cadre de  l'allocation des ressources. 

Dans  l'hypothèse où  le recrutement  de ce personnel  statutaire ne 
serait pas possible, il faudrait prévoir  des crédits relevant du poste 
"dépenses d'appui" afin de recruter des auxiliaires ou de faire appel 
à des experts nationaux détachés conformément  au règlement  Interne de 
la Commission en date du 22.05.1990, relatif aux mini-budgets. 

-  19 -

6. 

Incidence  financière  de  l'action  sur  les crédits  d'Intervention 
(part le B  du  budget) 

Les  crédits  couvriront  un  certain  nombre  de  frais  tels  que  droit 
d'accès  à des  bibliothèques, à des  banques  de données,  contrats 
d'évaluation  avec  des  Instituts, publication  et  traduction  de  rapport 
et  constitution  d'une  banque  de données  dont  le montant  peut  être 
évalués  à 4.675.000  ECU pour  1992. Les  contrats  d'évaluation 
permettront  principalement  de  réévaluer  les substances  déjà  autorisées 
par  la Commission,  d'où  l'impossibilité  de  facturer  les évaluations à 
des utilisateurs  en  particulier. Toutefois,  lorsqu'il  s'agit  de 
demander  l'autorisation pour  des  substances  nouvelles  émanant  de 
l'Industrie,  tous  les frais d'évaluation  et  de  constitution  de  dossier 
sont  à  leur  charge, ce qui  permet  de  restreindre  les coûts  de  ta 
Commission. 

Il est  estimé  que 51,5% de ces  crédits  seront  des  dépenses 
opérationnelles et  48,5% des dépenses  d'appui  sur  la base  des  critères 
du  règlement  mini-budget. 

Le  niveau  réel  des dépenses  de  nature  administrative  qui  peuvent  être 
Imputées  sur  la  ligne budgétaire  B8-530  sera  déterminé  annuellement 
par  la Commission,  conformément  aux  règles  du mini-budget  du 
22.5.1990. 

Certaines  dépenses  telles que  les contrats  d'évaluation  et  les droits 
à  des  bibliothèques devront  être  prévues  chaque  année  tandis que  pour 
la banque  de  donnée;  seuls  des  frais  de mise  à  jour  seront  nécessaires 
ce  qui  veut  que  les crédits  pour  les budgets  au  delà  de  1992 seront  de 
moindre  importance. 

Il  faut  préciser  que  le choix  des  instituts  toxicologiques  avec 
lequel s seront  passés  les contrats  variera  en  fonction  du  programme  de 
traval I annuel. 

7. 

Financement  des  dépenses  d'intervention 

Les  crédits  nécessaires  pour  cette  action  seront  fixés par  la 
procédure  budgétaire  annuelle.  Ils seront  couverts  par  révolution 
normale  des articles 85-300 et  B8-530 qui  doivent  tenir  compte  des 
contraintes  Imposées  par  le plafond  de  la rubrique  4 des  perspectives 
financières  et  d'un  examen  approfondi  des  autres  priorités  à  financer 
par  ces  articles. 

- 20 -

Montants estimé nécessaires pour  1992 : 

1)  B  5 . 3 00 
2)  B  8 / 5 . 3 00 

ÇJL 

2 . 4 10 
2 . 2 65 

CP 

844 
2 . 2 65 

Incidence sur  les ressources 

Dans  les années à venir,  Il pourrait être envisagé de faire payer une 
contribution aux personnes désirant  avoir  accès à  la banque de données 
créée pour  la Commission mais  les ressources resteront  insignifiantes 
par  rapport  aux dépenses. 

9.  Régime de contrôle 

Contrôle ordinaire. 

-  21 

-

PREVISIONS DE DEPENSES BUDGET  1992 

ACTION  PROJETEE 

MOYENS  D'ACTIONS 

DEPENSES (ECU) 

Documentation  scientifique 

Accès aux  bibliothèques 
importantes type BLAISE (UK) 
Chemical  Abstracts, National 
Library of Médecine (USA), 
DIMDI(FRG) etc. 

530.000 

Evaluation  Scientifique 

a.  Contrats avec des intstituts 
toxicolugiques pour le monitorage 
permanent  du développement  de la 
connaissance scientifique  pour 460 
additifs alimentaires et contaminants 
(20 contrats de  100.000 Ecu/ans) 
Complété les vide dans la literature 
par des travaux de laboratoire 
vérification  des résultats. 

b.  Identification  des priorités pour 
les évaluations 

r.  Etude critique par des experts 
renommés des dossiers composés 
sous points a. 

Publication des Evaluations 

Rédaction,  traductions des opinions 
du Comité Scientifique 

Constitution d'une banque 
de données 

1. Achat de terminaux  pour 

consultation  de la base centrale 

2.Développcment du Logiciel 

3.  Introduction des données 

initiales 

Coopération  Scientifique 

4.  Mise à jour 

organisation des réunions 
de coordination avec les 
les chefs de file des contrais 

2.000.000 

100.000 

310.000 

675.000 

100.000 

600.000 

100.000 

150.000 

200.000 

-  22  -

PREVISIONS  DE DEPENSES - BUDEGET 93-

ACTION  PROJETEE 

MOYENS D'ACTIONS 

DEPENSES 

Documentation  scientifique 

Accès aux  bibliothèques 

importantes  type BLAISE (UK) 
Chemical  Abstracts, National 
Library  of Médecine (USA), 
DIMDI(FRG) etc. 

530.000 

Evaluation  Scientifique 

a.  Contrats avec des intstituts 
toxicologiques  pour  le monitorage 
permanent  du  développement  de la 
connaissance scientifique  sur 460 
additifs  alimentaires et  contaminants 
(20 contrats  de 100.000  Ecu/ans) 
Complété les vides dans la  literature 
par  travaux  de  laboratoire 
vérification  des résultats. 

b.  Identification  des priorités  pour 
les évaiuatioas 

c. Etude critique par  les experts 
renomés  des dossier  composés 
sous points a. 

Publication  des  Evalutatioas 

Rédaction,  traductions  des opinions 

Exploitation  de la  banque 

Coopération  Scientifique 

du  Comité Scientifique 

1. Mise à jour 

organisation  des réunions 
de coordination  avec les 
les chefs  de file des contrats 

2.000.000 

100.000 

310.000 

675.000 

150.000 

200.000 

- 23 -

ANNEX 

Proposed staff estimates for Scientific Cooperation 

1.  A officials 

12 A officials 

The basic principle of  the approach chosen  for  the scientific cooperation 
proposal  is that of using to the maximum  the principle of subsidiarity. 
The scientific work would be carried out by  institutes and bodies  in the 
Member  States whose total  scientific graduate staff must  approach  that of 
the FOA namely 600 graduates  (eg over  100 in the MAFF  food science division 
In the UK. A similar number  In the food science staff of  the Max von 
Pettenkoffer  in Berlin +/- 30  In the Netherlands, ± 30  In  Denmark).  The 
Commission staff would be primarily responsible  for coordination of the 
work of  the national  bodies and  Institutes with  the SCF and servicing the 
SCF. The Commission staff would  therefore be very  limited  in number to 
about  2% of  the number of scientific staff  in the Member  States' institutes 
who are cooperating  in the scheme and whose work  they would be 
coordlnat ing. 
There would however be anciliiary tasks which devolve  from the consequences 
of  the achievement of  the Common Market and  the Commission's general 
responsibl111 ies. 

Principal  tasks are: 

- Acting as coordinators and scientific secretaries for each of  the seven 

subgroups of  the SCF dealing with 

-  add 111ves; 
-  novel  food; 
-  nutrition; 
-  packaging mater I a Is; 
-  flavours; 
-  contaminants 
-  hygiene. 

- The  fulfilment of mandatory  requirements  of directives requiring the 

assessment of dossiers presented by  Industry  for approval or reapproval. 
These concern  food additives ± 500, materials  In contact with food ± 
2000, novel  foods ± 200 In the first 3 years, flavours 11,000-12,000 
substances, solvents ±  15 and nutritional  evaluation  in support of 
legislation on  topics such as ROA's of vitamins and minerals, foods for 
special  nutritional  use and nutritional  labelling. 

- 24 -

These dossiers consist of scientific  research on toxicity, 
carcinogenicity etc and are mostly very  large.  The average cost to 
Industry  In producing  this  information  Is several million ECU per dossier 
and can be as much as 80 million ECU for one substance. 

The assessment  of a dossier will  take on the average 4-5 months and could 
take much  longer  for  larger  flies. The Commission staff would carry out the 
preliminary examination of the file for acceptability before allocating It 
to a national  institute. They would  then act as coordinators between the 
institute and  the SCF. 

- The  information submitted  in the flies will be stored  in retrievable 

electronic  form and this  Is the subject of a study contract by a systems 
analyst  (extracts from preliminary report  attached). Already approaching 
a million pages and estimated  to be several million  in five years 

It will need  to be easily retrievable  to meet  the requirement  for : 

-  updating of the files as new  information becomes available; 

-  review of  the assessments by the SCF  In the  light of this evidence 

on a five year basis; 

-  to meet  the commitment  for public access to all non-confident la I 

sclent If ic data-, 

-  to support  international  and bilateral  discussions on food safety 

quest ions. 

The management of  this data will  be a considerable  task. 

- The secretariat would also arrange the scientific support  for biannual 

consultation on food safety matters with  the US/FDA  (The FDA are sending 
15 staff  to Brussels for the next  food/pharmaceutlea is meeting).  Also 
the annual  bllaterals with Japan and Canada.  The achievement of the EEA 
will also require regular meetings of experts as will  relations and 
support with central  European Countries. 

- With  the adoption of the directives on food most of  the subjects dealt 
with by Codex Allmentarius  at national  level will now be dealt with 
using a coordinated Community approach.  Meetings of  the Codex  Involving 
scientific staff already exceed 8 weeks per year and the coordination of 
scientific questions will be a full  time task  for one man. 

- The expected adoption of  the GATT sanitary and phytosanltary code will be 

yet another Community obligation  to be serviced by the scientific 
coopérât Ion. 

- The coordination of  the control of  foodstuffs, which  Is a requirement 

placed on the Commission by the control  directive will  Imply also 
coordination of scientific support  as will  the effective operation of the 
food alert system. 

-  25  -

2. 

C  officials 

4  C  officials 

The  support  staff  of  4 Cs  Is commensurate  with  the A  staff  requested. 
Finally  It should  be  borne  In mind  that  the  cooperation  proposed  will 
eliminate  duplicates  of  work  by  Member  States  and  result  In economics  which 
will  for  exceed  the  coordination  staff  proposed  to  fulfil  Community 
obiigatIons. 

P.S.  Since  1 January  1990 over  100 new  dossiers  have  been  submitted  for 

évaluât ion. 

-  26  -

ELEMENTS  D'ANALYSE  COUT-EFFICACITE 

1. 

OBJECTIFS  ET  COHERENCE  AVEC  LA  PROGRAMMATION  FINANCIERE 

1.1. Object if(s) spécifique(s) de  l'action  proposée.  Il  doit  être 

quantifié  (dans  la mesure  du  possible) et  présenté  pour  chacune  des 
années  concernées  s'il  s'agit  d'une  action  pluriannuelle. 

L'objectif  principal  de  cette  action  est  de  permettre  au  Comité 
Scientifique  de  l'Alimentation  humaine  de  fonctionner  correctement  et 
donc  d'émettre  des  avis  sur  les dossiers  qui  lui  sont  soumis  dans  des 
délais  raisonnables.  Si  cet  objectif  est  atteint,  la Commission  sera 
alors  en  mesure  d'exercer  de  façon  satisfaisante  les compétences  que 
le Conseil  lui  a  confiées,  à  savoir  l'adoption  de  directives  contenant 
soit  des  listes positives  d'additifs  autorisés,  soit  des  %  maximum 
acceptables  de  décontaminants  soit  encore  les besoins  en  nutriments  de 
certaines  catégories  de  personne  (bébés,  diabétiques...).  Cet  objectif 
est  particulièrement  difficile  à  quantifier;  si  ce  n'est  en  nombre  de 
projet  de  Directive  à  réaliser  par  an. 

1.2.  L'action  est-elle  prévue  dans  la programmation  financière  de  la DG 

pour  les  années  concernées? 

Cette  action  sera  prévue  dans  la programmation  financière  de  1992  qui 
est  en  cours  d'élaboration  ainsi  que  dans  celle  des  années 
ulterleures. 

1.3.  Indiquez  à quel  objectif  plus  général  défini  dans  la  programmation 

financière  de  la DG  correspond  l'objectif  de  l'action  proposée. 

L'objectif  de  cette  action  se  situe  en  premier  lieu dans  le cadre  de 
L'objectif  général  de  l'achèvement  du marché  intérieur  et  de  façon 
plus  générale  dans  le cadre  de  l'harmonisation  de  la  législation  des 
Etats membres  et  de  la gestion  de  cette  législation  harmonisée. 

2. 

JUSTIFICATION  DE  L'ACTION 

2.1.  Justification  de  l'action  choisie  par  rapport  à une  alternative  qui 

permettrait  d'atteindre  les mêmes  objectifs.  La  justification  doit  se 
baser  notamment  sur  trois  critères: 

a)  coût 
b) effet  dérivés  (impact  au-delà  de(s) objectlf(s)  spéciflque(s)) 
c) effet  multiplicateurs  (capacité  de mobilisation  d'autres  sources  de 

fInancement) 

Deux  autres  solutions ont  été  envisagées  pour  atteindre  un  même 
résultat.  La  première  consistait  à effectuer  l'ensemble  des 
évaluations  au  sein  de  la Commission,  ce  qui  aurait  alors  nécessité  le 
recrutement  d'une  centaine  de  personnes  ainsi  que  l'achat  de  matériel 
et  de  documentation  appropriée. 

-  27 -

Cette solution a été  jugée  Irréaliste quant aux coûts  financiers 
qu'elle aurait engendrés.  Il faut savoir qu'aux USA,  la Food and Drug 
Administration dispose de moyens considérables pour effectuer  ce genre 
de travaiI. 

La deuxième possibilité aurait été  la création d'une Agence comme 
celle qui est prévue pour  les médicaments, mais  il s'est avéré que la 
multiplication de ce type d'organismes externes à  la Commission 
n'était pas politiquement souhaitable. De plus,  Il est 
particulièrement difficile d'en évaluer  les coûts financiers. 

La voie choisie à savoir  l'utilisation de ressources scientifiques 
nationales est donc en terme de coût  la plus économique même si 
certaines dépenses demeurent  à  la charge de  la Commission, notamment 
celles qui  sont  liées à  la réévaluation périodique des produits qui 
ont été autorisés.  Celles-ci ne représentent  d'ailleurs qu'une petite 
partie  des coûts engendrés par  les travaux  scientifiques qui  seront à 
la charge des Etats membres. 

De plus,  lorsqu'il  s'agit d'autoriser  une nouvelle substance, les 
dossiers sont établis par  les industries concernées. Seuls  les frais 
de fonctionnement du Comité Scientifique restent à  la charge de la 
Commission. 

La réussite de  l'objectif  principal  aura un  impact  Important sur  les 
entreprises qui  pourront  être fixées plus rapidement  sur  le sort 
réservés aux  substances soumises à l'évaluation. 

3.  SUIVI  ET EVALUATION DE L'ACTION 

3.1.  Indicateurs de performance  sélectionnés 

Nombre de substances évaluées/par  an 
Délai  pour obtenir  l'avis du Comité scientifique 
Nombre de projet de Directive 

3.2. Modalité et périodicité de  l'évaluation  prévues 

Une évaluation annuelle sera effectuée par  rapport au programme de 
travail  qui aura été élaboré dans  le cadre du Comité permanent  des 
denrées alimentaires et qui comportera des objectifs spécifiques et 
quantifiés et  les  Indicateurs de performance y afférants. D'autre 
part, chaque contrat passé avec des  Instituts toxIcologiques fera 
l'objet d'une évaluation. 

3.3. Principaux  facteurs d'Incertitude pouvant affecter  les résultats 

spécifiques de  l'action. 

Le principal  facteur d'incertitude provient d'une part des 
possibilités réelles de recruter  le personnel  nécessaire pour  assurer 
au sein de  la Commission  la coordination et  le suivi  de cette activité 
et d'autre part des crédits qui pourront être effectivement alloués 
dans  le cadre de  la ligne B5-300. 

Du côté des Etats membres, Il s'agit surtout d'une volonté politique 
de s'Impliquer dans cette coopération scientifique. 

- 28 -

Fiche d'Impact  de certains actes  législatifs 
sur  les PME et  l'emploi 

Projet  de Directive du Conseil  concernant  l'assistance  des Etats membres à 
la Commission et  leur coopération en matière d'examen  scientifique des 
questions relatives aux denrées alimentaires. 

1. OBLIGATIONS ADMINISTRATIVES DECOULANT DE L'APPLICATION DE LA 

LEGISLATION POUR LES ENTREPRISES 

Néant. 

2. AVANTAGES  POUR L'ENTREPRISE 

- OUI 
-  LESQUELLES  Le système  Instauré par  la directive devrait 
permettre grâce à un meilleur fonctionnement 
du Comité Scientifique de  l'Alimentation 
humaine à  la Commission et au Conseil  de se 
prononcer  plus rapidement  sur  les demandes 
visant à faire admettre de nouveaux  additifs, 
arômes  ... ce qui est très  Important pour 
les entreprises qui sont à  l'origine  des 
recherches. 

3.  INCONVENIENTS POUR  L'ENTREPRISE 

(coûts supplémentaires) 

- NON 

4.  EFFETS SUR L'EMPLOI 

Néant. 

5. Y A-T-IL EU CONCERTATION PREALABLE AVEC LES PARTENAIRES 

SOCIAUX ? 

- NON 

6. Y A-T-IL UNE APPROCHE ALTERNATIVE MOINS CONTRAIGNANTE ? 

Non. 

ISSN 0254-1475 

COM(91) 16 final 

DOCUMENTS 

EN 

03 

Catalogue number : CB-CO-9M36-EN-C 
ISBN 92-77-70938-3 

PRICE 

l-30jM«et:3.50ECU 

per iddirionil 10 ft$ui  1.25 ECU 

Office for Official Publications of the European Communities 
L-2985 Luxembourg