Proposal for a COUNCIL REGULATION ( EEC ) laying down Community procedures for contaminants in food
Date: 1992-02-13
Institutions: European Commission
Subjects: food contamination, food standard, foodstuff, human nutrition, public health, toxic substance

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) 

- 2 -

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. 

-  3  -

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. 

-  4 -

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. 

- 5 -

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) 

- 6 -

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. 

HAS ADOPTED  THIS REGULATION  : 

-  7  -

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. 

-  8  -

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. 

-  9  -

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 cW  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 

(8)  OJ  N° L 291  Of  19.11.1969, p. 9. 

For  the Counc 11 

The  President 

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