CELEX: 51991PC0016
Language: en
Date: 1991-04-03
Title: 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

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)
 ---pagebreak---                                           - 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.
 ---pagebreak---                                          - 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 controls 2 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.
 ---pagebreak---                                        - 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.
 ---pagebreak---                                          - 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    Albert 3 ,   Collins 4 and   Pimenta 5  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
 ---pagebreak---                                    - 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.
 ---pagebreak---                                      - 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.
 ---pagebreak---                                         - 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)
 ---pagebreak---                                        - 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.
 ---pagebreak---                                     - 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.
 ---pagebreak---                                           - 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:
 ---pagebreak---                                     - 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.
 ---pagebreak---                                   - 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.
 ---pagebreak---                                      - 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/EEC 1 .
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.
 ---pagebreak---                                    - 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
 ---pagebreak---                                      - 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.
 ---pagebreak---  ---pagebreak---                                        - 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.
 ---pagebreak---                                 - 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.
 ---pagebreak---                                      - 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.
 ---pagebreak---                                    - 20 -
          Montants estimé nécessaires pour 1992 :
                             ÇJL             CP
    1) B 5 . 3 0 0           2.410            844
   2) B 8 / 5 . 3 0 0        2.265           2.265
    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.
 ---pagebreak---                                              - 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         530.000
                                Library of Médecine (USA),
                                DIMDI(FRG) etc.
 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.           2.000.000
                               b. Identification des priorités pour
                               les évaluations                         100.000
                               r. Etude critique par des experts
                               renommés des dossiers composés
                               sous points a.                          310.000
Publication des Evaluations    Rédaction, traductions des opinions
                               du Comité Scientifique                  675.000
Constitution d'une banque      1. Achat de terminaux pour
de données
                              consultation de la base centrale        100.000
                              2.Développcment du Logiciel             600.000
                              3. Introduction des données
                              initiales                               100.000
Coopération Scientifique      4. Mise à jour                          150.000
                              organisation des réunions
                              de coordination avec les
                              les chefs de file des contrais         200.000
 ---pagebreak---                                           - 22 -
                      PREVISIONS DE DEPENSES - BUDEGET 93-
 ACTION PROJETEE                MOYENS D'ACTIONS                     DEPENSES
Documentation scientifique   Accès aux bibliothèques
                                importantes type BLAISE (UK)
                                Chemical Abstracts, National         530.000
                                Library of Médecine (USA),
                               DIMDI(FRG) etc.
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.           2.000.000
                               b. Identification des priorités pour
                               les évaiuatioas                         100.000
                               c. Etude critique par les experts
                               renomés des dossier composés
                              sous points a.                           310.000
Publication des Evalutatioas   Rédaction, traductions des opinions
                              du Comité Scientifique                   675.000
Exploitation de la banque
                               1. Mise à jour                         150.000
Coopération Scientifique
                              organisation des réunions
                              de coordination avec les
                              les chefs de file des contrats         200.000
 ---pagebreak---                                       - 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.
 ---pagebreak---                                        - 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.
 ---pagebreak---                                      - 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.
 ---pagebreak---                                       - 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.
 ---pagebreak---                                      - 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.
 ---pagebreak---                                       - 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.
 ---pagebreak---  ---pagebreak---                                                                                  ISSN 0254-1475
                                                                    COM(91) 16 final
                                                      DOCUMENTS
EN                                                                                          03
                                 Catalogue number : CB-CO-9M36-EN-C
                                                               ISBN 92-77-70938-3
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