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 64/414/EEcW 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. 

KSN 0254-1475 
COM (91) 523 final 
DOCUMENTS 
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ISBN 92-77-78982-4 
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