CELEX: 51991PC0523
Language: en
Date: 1992-02-13
Title: Proposal for a COUNCIL REGULATION ( EEC ) laying down Community procedures for contaminants in food

COMMISSION OF THE EUROPEAN COMMUNITIES
                                       C0M(91) 523 final - SYN 379
                                       Brussels, 13 February 1992
                            Proposal for a
                      COUNCIL REGULATION (EEC)
     laying down Community procedures for contaminants In food
                    (presented by the Commission)
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                           EXPLANATORY MEMORANDUM
Contaminants may enter food by Incorporation during the growth of organisms
which are used as food and at all subsequent stages of processing and
marketing.
Contaminants are substances In general present In the environment and that
result In food as a consequence of the production or preparation of the
food and not intentionally added to It. Contaminants are substances that
should not be present in foodstuffs, if possible, or else be kept at
minimum levels. The presence of a contaminant In food has normally a
residual character. In most of the cases contaminants are very difficultly
removed from the foodstuff even after applying normal operations Involved
 In processing, (washing, filtering or, In general, purification or
separation techniques.
However, the presence of a contaminant does not render automatically a food
unfit for human consumption or unwholesome.   On the other hand, there are
undesirable substances that are naturally present In certain foods, like
natural toxicants, and they are not contaminants. These natural toxicants
are normally eliminated during the preparation (In particular cooking) of
foods.
The best way of avoiding the presence of contaminants In food is acting at
the sources to limit their presence in the environment. The Community has
already a wide variety of measures aiming at eliminating or limiting the
presence of dangerous substances In the environment that may enter the food
chain as contaminants.
An example of the effectiveness of the policy of taking preventive measures
at source for environmental contaminants is the decrease of the presence of
 lead as a contaminant in food following the progressive Introduction of
 lead free petrol.
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Raw materials with levels of contaminants that could render the food
dangerous for the public health or unwholesome should not be used for the
manufacture of foodstuffs. The entry into the food chain of contaminants
can therefore be avoided by monitoring at the early stages in the food
chain, e.g. the raw materials.
Advances in scientific knowledge are not only enabling the effect of these
substances on public health and their origins in food to be better
understood, but also are enabling them to be detected at decreasingly lower
levels.
Many of the existing rules on contaminants which are laid down at Member
State level are the result of an historical evolution of measures adopted
to deal with specific situations and as such may differ.   These differences
can constitute an obstacle to the common market in foodstuffs which has to
be achieved by 1992.
 In assessing the tolerable level of a contaminant In food it is necessary
from toxicoiogical studies to define a tolerable dally intake.   Since the
same contaminant may occur In a variety of foods It is necessary when
defining the tolerable level to consider all the likely sources of the
contaminant and to define the tolerable levels in the light of the
contribution of various foods to the diet.
 It Is therefore inappropriate to lay down contaminant levels in vertical
 legislation for specific food groups without taking Into consideration its
presence in other foods.   A flexible instrument is envisaged which enables
decisions to be made in view of the general toxicoiogical objectives to be
achieved and taking into account all aspects of food production and
processing.
Water Is, however, a special case since it Is not only consumed directly
and used as a food ingredient but Is also used for washing and processing
foodstuffs.
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Rules for pesticides and veterinary medical products derive directly from
their use In agriculture and allowable residues form part of the
considerations relating to their use.
Similarly, contaminants arising from migration from materials in contact
with food are best controlled by regulating the material in contact rather
than by fixing limits in the foodstuff Itself.
The occurrence of natural radioactivity In foods Is the result of a natural
distribution of radioactive isotopes in the biosphere Including the human
organism.   It Is therefore necessary only to regulate the presence of
radioactivity In foodstuffs In relation to nuclear Incidents and following
the occurrence at Chernobyl; the Community has adopted a permanent
regulation to this effect.
Microbiological contamination will be the subject of separate general
provisions.
Once this framework Regulation is adopted, the Commission Intends to
examine existing national rules on contaminants in the light of modern
toxicoiogical assessment with a view to adopting Community rules where
appropriate.   The Commission has already requested the communication of
national rules In order that work may be started on the scientific
assessment.   Subsequent national measures will be notified under the
procedure of Council Directive 83/189/EEC which provides for a delay period
for national Implementation, permitting appropriate action to be taken at
Community level.
 In carrying out this work the Commission intends to give priority to those
contaminants of special concern such as heavy metals.
Action may be generated directly at Community level as a resuit of
scientific research, of cooperation on food scientific assessment or
 Information arising from public controls, or from the food rapid alert
system.
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                  Proposal for a Council Regulation (EEC)
         laying down Community procedures for contaminants in food
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community,
and in particular Article 100 A thereof,
Having regard to the proposal from the Commission^1), and In cooperation
with the European Par I lament<2),
Having regard to the opinion of the Economic and Social Committee^,
Whereas It Is Important to adopt measures with the aim of progressively
establishing the internal market over a period expiring on 31 December
1992; whereas the Internal market shall comprise an area without internal
frontiers in which the free movement of goods, persons, services and
capital is ensured;
Whereas the differences in rules adopted by the Member States may hinder
the functioning of the common market and whereas It Is necessary to lay
down a procedure for the adoption of harmonized Community rules;
Whereas contaminants may enter Into food at any stage from production to
consumption ;
Whereas it is essential, in the interest of public health protection, to
keep these contaminants at levels which are toxicoiogically acceptable ;
(1)
(2)
(3)
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Whereas further restrictions should be observed whenever they are
achievable through good professional practices ; whereas the compliance
with such good practices can be efficiently controlled by public
authorities, given the professional training and experience of their
agents ;
Whereas this regulation should apply without prejudice to the provisions
adopted In the context of more specific Community rules ;
Whereas Member States are required to notify draft technical standards and
regulations in foodstuffs to the Commission, Including those on
contaminants, through Council Directive 83/189/EEC<4), as last amended by
Council Directive 88/182/EEC*5), and whereas the notification procedure In
that directive shall continue to apply to foodstuffs;
Whereas the Scientific Committee for Food shall be consulted on all
questions which may have an effect on public health;
(4) OJ N° L 109 Of 26.04.83, p. 8.
(5) OJ N° L 81 of 26.03.88, p. 75.
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HAS ADOPTED THIS REGULATION :
                                  Article 1
1.    This Regulation lays down the procedure for establishing rules on
      contaminants In foodstuffs.
2.    This Regulation shall apply without prejudice to the provisions
      adopted In the context of more specific Community rules.
                                  Article 2
For the purposes of this Regulation "contaminant" means any substance not
 Intentionally added to food, which Is present In such food as a result of
the production, manufacture, processing, preparation, treatment, packing,
packaging, transport or storage of such food or as a result of
environmental contamination.
                                  Article 3
1.    No foodstuff shall be marketed if it contains a contaminant in an
      amount which Is toxicoiogically unacceptable.
2.    Furthermore, contaminants shall be kept at levels which are as low as
      reasonably achievable through good practices during all stages
      mentioned in Article 2.
3.    Where necessary to Implement paragraph 1, maximum tolerances for
      specific contaminants shall be estai I shed In accordance with the
      procedure laid down in Article 8.
      These tolerances shall be adopted in the form of a non-exhaustive
      Community list and may Include :
      -  different limits for the same contaminant In different foodstuffs
      -  analytical detection limits
      -  a reference to the method of sampling and analysis to be applied.
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                                   Article 4
In derogation of Article 10 of Council Directive 83/189/EEC of
28 March 1983( 6 ) laying down a procedure for the provision of information
in the field of technical standards and regulations, as last amended by
Council Directive 88/182/EEC^ 7 ^, notification of draft technical standards
and regulations on contaminants shall continue to be made using the
procedure of Articles 8 and 9 of that Directive.
                                   Article 5
Provisions that may have an effect upon public health shall be adopted
after consultation with the Scientific Committee for Food.
                                   Article 6
1.   Where a Member State, as a result of new information or of a
     re-assessment of existing Information, has detailed grounds for
     considering that a contaminant In food, although complying with this
     Regulation or specific Regulations adopted pursuant to this
     Regulation, endangers human health, that Member State may temporarily
     suspend or restrict application of the provisions in question in its
     territory.    It shall immediately inform the other Member States and
     the Commission thereof and give reasons for its decision.
2.   The Commission shall examine the grounds given by the Member State
     referred to in paragraph 1 as soon as possible within the Standing
     Committee on Foodstuffs, and shall then deliver its opinion forthwith
     and take the appropriate measures.
(6)  OJ N° L 109 Of 26.04.83, p. 8.
(7)  OJ N° L 81 Of 26.03.88, p. 75.
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                                      Article 7
Member States shall not prohibit or restrict trade In foods which comply
with this Regulation or specific Regulations adopted pursuant to this
Regulation for reasons related to aspects covered by the provisions of this
Regulation.
                                      Article 8
1.    Where the procedure laid down in this Article is to be followed, the
      Commission shall be assisted by the Standing Committee on Foodstuffs,
      set up under Decision 6 4 / 4 1 4 / E E c W acting In an advisory capacity,
      hereinafter referred to as "the Committee".
2.    The Chairman shall submit to the Committee a draft of 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 taking a vote.
3.    The opinion shall be recorded in the minutes; in addition, each Member
      State shall have the right to ask to have Its position recorded in the
      minutes.
4.    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 9
This Regulation shall enter into force on 1 January 1993.
This Regulation shall be binding In Its entirety and directly applicable in
a 11 Member States.
Done at                                                        For the Counc 11
                                                               The President
 (8)  OJ N° L 291 Of 19.11.1969, p. 9.
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                                                              COM (91) 523 final
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