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) 
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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. 
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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. 
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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. 
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(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 
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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. 
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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. 
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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) 
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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. 
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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. 
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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: 
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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. 
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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. 
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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. 
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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 
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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. 

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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. 
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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. 
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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. 
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Montants estimé nécessaires pour 1992 : 
ÇJL CP 
1) B 5.300 2.410 844 
2) B 8/5.300 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. 
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PREVISIONS DE DEPENSES BUDGET 1992 
ACTION PROJETEE 
Documentation scientifique MOYENS D'ACTIONS 
Accès aux bibliothèques 
importantes type BLAISE (UK) 
Chemical Abstracts, National 
Library of Médecine (USA), 
DIMDI(FRG) etc. DEPENSES (ECU) 
530.000 
Evaluation Scientifique 
Publication des Evaluations 
Constitution d'une banque 
de données 
Coopération 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 
Rédaction, traductions des opinions 
du Comité Scientifique 675.000 
1. Achat de terminaux pour 
consultation de la base centrale 100.000 
2.Développcment du Logiciel 600.000 
3. Introduction des données 
initiales 100.000 
4. Mise à jour 150.000 
organisation des réunions 
de coordination avec les 
les chefs de file des contrais 200.000 
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PREVISIONS DE DEPENSES - BUDEGET 93-
ACTION PROJETEE 
Documentation scientifique 
Evaluation Scientifique MOYENS D'ACTIONS DEPENSES 
Accès aux bibliothèques 
importantes type BLAISE (UK) 
Chemical Abstracts, National 530.000 
Library of Médecine (USA), 
DIMDI(FRG) etc. 
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 
Publication des Evalutatioas 
Exploitation de la banque 
Coopération Scientifique c. Etude critique par les experts 
renomés des dossier composés 
sous points a. 310.000 
Rédaction, traductions des opinions 
du Comité Scientifique 675.000 
1. Mise à jour 150.000 
organisation des réunions 
de coordination avec les 
les chefs de file des contrats 200.000 
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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. 
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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. 

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