CELEX: 51992PC0128
Language: en
Date: 1992-03-30
Title: 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

COMMISSION OF THE EUROPEAN COMMUNITIES
                                                  C0M(92) 128 final  - SYN 332
                                                  Brussels, 30 March 1992
                                  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)
fer-'-
 T     Sf
 ---pagebreak---                          'c -
                 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;
 ---pagebreak---                         - y
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.
 ---pagebreak---                                       'A-
                                    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
 ---pagebreak---                                        "<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  the Sclent ific Committee for Food should be involved much more
                       policies that: affect food, diet and publ ic 1health:
widely ii n Commun i t y
Whereas  the process of achieving a satisfactory scientific b ase for matters
relating to food saifetv' must,, in the interests of consumers and 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
 ---pagebreak---                                     -/ -
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.
 ---pagebreak---                                   -I
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.
 ---pagebreak---                                       e-
                                  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
 ---pagebreak---                                      -9-
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.
 ---pagebreak---                                    -yfC-
                                 Artlcle 7
This Directive is addressed to the Member States
Done at Brussels,                             For the Council
                                              The President
 ---pagebreak---                                    -H-
                                 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.
 ---pagebreak---  ---pagebreak---                                                                      ISSN 0254-147
                                                              COM(92)128fina
                                                      DOCUMENTS
EN                                                                             1;
                                Catalogue number: CB-CO-92-141-EN-(
                                                             ISBN 92-77-42657-
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