COMMISSION OF THE EUROPEAN COMMUNITIES 
C0M(92) 128 final - SYN 332 
Brussels, 30 March 1992 
fer-'-
T Sf Amended 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 pursuant to Article 149(3) 
of the EEC-Treaty) 
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EXELANAIQBY_MEMQBAMDI1M 
1 . This modified proposal introduces those amendments 
voted on 12 March 1992 by the European Parliament which, 
in some cases having been subjected to editorial changes, 
the Commission can accept. 
The modifications concern the following points and are 
acceptable for the reasons stated: 
the introduction of recitals and amendments to 
articles which clarify the scope of the directive; 
the introduction of a more equitable basis for the 
distribution to the institutes in the Member States of 
the tasks envisaged to be subject to the scientific 
co-operation; 
the introduction of an undertaking to establish an 
inventory of the relevant scientific expertise within 
the European Community and to encourage the 
maintainance of that expertise by a process of peer 
review; 
clarification of the procedure by which the programme 
of work to be subject to the scientific co-operation 
will be determined; 
the introduction of an undertaking to inform the 
Parliament of the operation of the scientific co­
operation on a regular basis; 
further definition of the principal tasks to be 
carried out under the scientific co-operation. 
2. The following amendments were not acceptable to the 
Commission and for the following reasons: 
recitals relating to the overall structure of 
Community food policy and which are therefore not 
appropriate to the scope of the proposal; 
recitals and amendments to articles instituting 
consumer involvement which is not appropriate in view 
of the strictly scientific nature of the examination 
of the questions envisaged by the proposal; 
the introduction of a Community system of appraisal 
and accreditation of scientific institutes in the 
Member States which is an unnecessary assumption of 
responsibilities best left to the Member States; 
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the introduction of a measure of public access to the 
proceedings relating to the scientific examination of 
questions relating to foodstuffs and the personal 
interests of the members of the Scientific Committee 
for Food which goes beyond that reasonably necessary 
for the proper and smooth operation of the scientific 
co-operation. 
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Amended 
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, novel foods and processes, hygiene, food 
quality, labelling, methods of analysis, risk assessment techniques, and 
inspection and enforcement, particularly when these questions concern human 
health; 
Whereas consumers are entitled to a Community food policy which promotes 
safe food particularly regarding nutritional, microbiological and 
toxicological issues: 
1 O.J. No. C 108, 23.4.1991, p.7 
2 
3 O.J. No. C 14, 20.1.1992, P.6 
"<7 " 
Whereas in order to assist with this task the Commission set up a 
Scientific Committee for Food by Decision 74/234/EEC;1 
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 
widely i 
Whereas the Sclent ific 
i n Commun i t y 
the 
relating to process 
food sai Committee 
policies 
of 
fetv that 
achieving 
' must, , in for Food should be 
: affect food, diet involved 
and publ 
a satisfactory scientific b 
the interests of consumers much more 
ic 1 
ase 
and health: 
for matters 
industry be 
independent, transparent and effective: 
Whereas in order to ensure the smooth running of this Committee the 
Commission needs scientific support from the Member States; 
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 open access to the information and assistance 
available in the Member States, which must facilitate the accomplishment of 
its work in an open way: 
Whereas the completion of the internal market and the need to protect 
standards in the Community must give rise to increased participation of the 
Community represented by the Commission in the meetings and work on 
foodstuffs of international organisations such as the WHO, FAO, JECFA, 
GATT, Council of Europe, OECD and also in bilateral relations; 
1 O.J. No. L 136, 20.5.1974, p.1 
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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 
available; 
Whereas it is necessary to enhance and strengthen the remit and expertise 
of the Scientific Committee for Food, particularly with the aim of 
increasing the effectiveness of the EC in food issues: 
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: 
Article 1 
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 assistance it needs in the scientific examination of 
questions of public interest relating to food, particularly in the 
field of public health, through disciplines such as medicine, 
nutrition, toxicology, biology, microbiology, biotechnology, novel 
foods and processes, methods of analysis, risk assessment 
techniques, physics and chemistry. 
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2. (a) This Directive shall apply when a Council act requires the opinion 
of the Scientific Committee for Food. 
(b) For the purposes of the completion and operation of the internal 
market this Directive shall also apply to any question relating to 
the protection of the health and safety of persons arising from the 
consumption of food, in particular the composition of food, 
processes which are liable to modify food, the use of food 
additives and other processing aids as well as the presence of 
contaminants and the nutritional impact of Community legislation on 
diet and health. 
Article 2 
1. Each Member State shalI designate the authority or body which wi11 
be responsible for the cooperation with the Commission and for 
distribution of work to appropriate Institutes within Member States 
as regards the tasks laid down in Article 3 and shall notify the 
Commission accordingly. 
2. The tasks to be carried out In accordance with the inventory of 
tasks adopted in accordance with Article 3(2) 1st indent, shall be 
distributed between the responsible authorities or bodies mentioned 
in paragraph 1. by common agreement between the Commission and the 
competent authorities or bodies of the Member States on the basis 
of scientific expertise and within the limits set by the resources 
available in the Member States. 
3. The Commission shall also: 
a) Initiate a Community inventory of scientific expertise and 
excellence on these issues. 
b) Encourage international peer review assessment of such 
laboratories and personnel. 
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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 the Annex. 
2. The following measures shall be executed in accordance with the 
procedure laid down in Article 5: 
- establishment, and updating at least every six months, of the 
inventory of tasks and their associated priorities; 
- establishment of rules for the administrative management of the 
cooperat ion; 
- 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; 
Article 4 
The Commission may, after consultations with the authorities or bodies 
mentioned in Article 2(1). invite third countries to participate in the 
carrying out of the tasks mentioned in Article 3(2). 1st indent. 
Article 5 
The Commission shall be assisted by the Standing Committee on Food set up 
by Council Decision 69/414/EEC.1 
1 O.J. No. L 291, 19.11.1969, p.9 
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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. 
Article Sb 
The Commission shall report to the European Parliament on the structures, 
work and efficiency of the Scientific Committee for Food within three years 
of the implementation of this Directive and every three years thereafter. 
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. 
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Artlcle 7 
This Directive is addressed to the Member States 
Done at Brussels, For the Council 
The President 
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A N NEX 
The principal tasks to be carried out by the designated authorities or 
bodies participating in the cooperation shall include: 
drawing up protocols for the assessment of risks relating to food 
components and elaborating methods of nutritional evaluation. 
- assessing the nutritional adequacy of the diet. 
examining test data submitted to 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 Commity's international commitments 
by providing expertise on food safety questions. 

ISSN 0254-147! 
COM(92)128fina 
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Catalogue number: CB-CO-92-141-EN-( 
ISBN 92-77-42657-
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