Proposal for a COUNCIL DIRECTIVE ON THE SUBJECT OF ADDITIONAL MEASURES CONCERNING THE OFFICIAL CONTROL OF FOODSTUFFS
Date: 1992-02-06
Institutions: European Commission
Subjects: European standard, administrative cooperation, food inspection, foodstuff, professional qualifications, research body

COMVIISSION  OF  THE  EUROPEAN  COMMUNITIES 

C0M(91) 526  final - SYN 377 

Brussels, 6  February  1992 

Proposal  for a 

COUNCIL  DIRECTIVE 

ON THE SUBJECT OF ADDITIONAL  MEASURES  CONCERNING 

THE OFFICIAL  CONTROL  OF  FOODSTUFFS 

(presented  by  the Commission) 

-1  -

EXPLANATORY NOTE 

Council  Directive 89/397/EEC of  14 June 1989 on the official  control of 
foodstuffs, which deals with the general  principles of  food control, ai lows 
for  the adoption of more specific provisions. Article 13 of  that Directive, 
which was  Introduced at the request of the European Parliament, suggests 
provisions  in the field of the basic and further  training of food 
inspectors, quality standards for officiai  food control  laboratories, a 
Community  Inspection service and  the exchange of  information on  Inspections 
at Community  level. Article 13 requests the Commission  to report  to the 
European Pari lament and to the Council  about  the possibility of 
establishing such provisions and  in its document  (90) 392 final of  13 
September  1980, the Commission compiled with that  request. The document, 
which was generally weiI  received by the Member States, made  it clear  that 
further provisions  in this field are an essential  precondition  for an 
unrestricted  trade  In foodstuffs between the Member  States. The Directive 
proposed herewith  Is largely a consequence of  that document. 

Articles 1 and 2 

These articles define the scope of  the Directive. 

Article  3 

Widely differing methods are used  In the Member States for  the official 
control of  foodstuffs. Not only do considerable differences occur between a 
central  approach on the one hand, and a  local  approach on the other, but  In 
one country  the emphasis may be placed on the advisory  role of the food 
inspector, whereas  in another  he or she  is clearly seen as having a 
po11cIng  roIe. 

In point of  fact, the professional  function of a food  Inspector  In the 
Community  has not been defined.  In some Member States the term "food 
Inspector" applies to the academically  trained and  In others that  Is not 
the position. 

Although  there  Is no point  In drawing up Community  requirements for the 
training of  food  Inspectors, as  Song as the national  inspection systems 
diverge so sharply and the function  is not cleariy defined,  it Is 
nevertheless desirable to allocate areas  In which personnel  responsible for 
official  inspection must  have received certain minimum  training. This 
Includes such areas is (veterinary) medicine, chemistry, microbiology, food 
processing, food hygiene, law, etc. 

-z-

Artlcle  4 

In order  to avoid  barriers  to  trade  and  unnecessary  duplication  of 
laboratory  tests, mutual  recognition of  the  laboratory  results obtained  by 
the  inspection bodies  should  be  regarded  as an essential  precondition  for 
unrestricted  trade  in foodstuffs  between  Member  States. Given  that  these 
laboratory  results  serve  not  only  as  the basis  for  criminal  proceedings 
within  a Member  State  but  also - under  the  rapid  alert  system  -  as  the 
basis  for  Community  measures,  steps  should  be  taken  In the  Interests  both 
of  human  health  and  of  legal  security  to  introduce  mandatory  requirements 
in the  field  of  reliability  and  accuracy.  This means  that,  in  those 
laboratories  entrusted  by  the  competent  authorities  of  the Member  States 
with  the  control  of  foodstuffs,  a system  of  quality  standards  should  be 
Introduced,  so  that  the  quality  of  the  test  data  can  be  guaranteed. 

The  European  Standard  EN 45,000  series  provides  a satisfactory  model  for 
the  repetItIve work  of  these  laboratories but  it should  be  supplemented  by 
some  provisions  of  the OECD  principles  of  good  laboratory  practice  in order 
to  have  a  random  check  on  the  compliance  of  non  repetitive  laboratory  work 
with  Standard  Operating  Procedures. 

Article  5 

It  is essential  that  for  mutual  recognition  of  laboratory  results  the 
working  methods  of  analysis, whenever  possible,  are  fully  validated,  i.e. 
methods  which  have  been  subjected  to a  full  collaborative  trial. 

Guidelines  on  criteria  for  the  validation  are given  In the Annex  of  Council 
Directive  85/591/EEC. 
The  first  section  of  that  Annex  states  that  methods  of  analysis  shall  be 
examined  with  respect  to specificity,  limit  of  detection,  sensitivity, 
accuracy  and  so  on. 

Provision  1  (III) of  this Annex  specifies  parameters  such  as  repeatability 
and  reproduceablIIty  values.  Information  on  these  can  be obtained  by 
carrying  out  a  full  collaborative  trial. 

§-

Article  6 

There are a number of  arguments  In favour of designating  a number of 
Community officials, who are entitled  to exercise control  acts  In the 
Member  States. As has been recognized  In other parts of  the food sector 
Including  fisheries, fresh meat, fruits and vegetables and wine, these 
officials may have a beneficial  Influence on the quality  and hygiene of 
products and production. 

They are expected  to : 

help  to coordinate  the uniform application of Community  law and, 

to assist  In resolving Member  States problems emanating from the free 
movement of  foodstuffs  In the Community. 

Furthermore  they may  help Member  States  in providing greater uniformity  in 
their control  procedures and  to promote optimal  use of  the Commission's 
Rapid Alert  System. 
This will  provide  for a more effective system of dealing with calamities 
and emergencies  in relation  to foodstuffs. 

Articles 7 and  8 

In July  1988 the European Parliament  adopted  the Stauffenberg  report 
(Document A2-248/87) on  Judicial  and administrative assistance between 
authorities and courts of  the Member  States  in respect of  legal provisions 
and quality  standards applicable  to foodstuffs. When debated  In Par ! lament 
the report was welcomed by the Commission, who undertook  to consider  the 
needs for  Increased  Judicial  and administrative assistance. The present 
article 7 reflects the report's view on administrative assistance  in ail 
supervisory  standards  in connection with  legal provisions and quality 
standards and all  proceedings  for  infringements of  the  law, applicable to 
foodstuffs. 
Article 8  Involves, on request, the Commission  In this exchange of 
Information. 

Article  10 

In order  to  improve confidence  In food products coming  from other Member 
States this article  foresees  In the publication of  the results of  the 
Commission's coordinated  control  programme. 

Article 11 

The deadlines  laid down  In this article  take account of  the  legislative 
procedures which must be completed  in the various Member States. 

-h-

PROPOSAL  FOR A COUNCIL DIRECTIVE 

ON THE SUBJECT OF ADDITIONAL MEASURES  CONCERNING 

THE OFFICIAL CONTROL OF  FOODSTUFFS 

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, 

In cooperation with  the European Parliament, 

Having  regard  to the opinion of  the Economic and Social  Committee, 

Whereas  it  is necessary  to adopt  measures with  the aim of progressively 

establishing  the  internal  market  over  the period  expiring  on 31  December 

1992; whereas  the  Internal  market  comprises  an area without  Internal 

frontiers  In which  the  free movement  of goods, persons, services and 

capital  is ensured; 

Whereas  trade  In foodstuffs occupies a very  Important  place  in the  Internal 

market; 

Whereas  it  is therefore essential  that  the application of Council  Directive 

89/397/EEC^1^ on  the official  control  of  foodstuffs  Is uniform  throughout 

the Member  States; whereas  this Directive  lays down general  rules on the 

official  control  of  foodstuffs; 

Whereas  there  Is a need  for  additional  rules designed  to  Improve  the 

control  procedures  In force  In the  Community; 

Whereas Member  States should  take  the necessary  action  to ensure  that  the 

staff of  the competent  authorities have sufficient  technical  and 

administrative  competence; 

(1) OJ  nr L 186 of  30.06.1989, p. 23 

Whereas,  In order  to guarantee  the quality of  the  test  data, a system of 

quality  standards should  be  Introduced  for  laboratories entrusted  by  the 

Member  States with  the official  control  of  foodstuffs, whereas such a 

system  should  comply with generally  accepted  and standardized  norms; 

whereas,  In addition,  It  is essential  that  these  laboratories use vai'dated 

methods of analysis, whenever  possible; 

Whereas  the development  of  trade  in foodstuffs between  the various Member 

States necessitates  closer  cooperation  between  the authorities  involved  in 

the control  of  foodstuffs; 

Whereas general  rules are required  for  the Commission  officials  specialized 

In the control  of  foodstuffs which  cooperate with  specific officials of  the 

Member  States  In order  to ensure  the uniform  application of  legislation on 

foodstuffs; 

Whereas provisions should  be  laid down under which  the national  authorities 

and  the Commission must  provide mutual  administrative assistance with a 

view  to ensuring  proper  application of  the  legislation on  foodstuffs, in 

particular  through  preventive  action  and  the detection of  Infringements or 

behaviour  suspected  of  Infringing the rules; 

Whereas,  In view of  the nature of  the  Information exchanged  pursuant  to 

this Directive,  It should  be covered  by the requirements of commercial  or 

professional  secrecy; 

Whereas  the results of  the  implementation of  the  Commission's 

coordinated  programme  on  the control  of  foodstuffs should  be published; 

HAS ADOPTED THIS DIRECTIVE: 

Article 1 

1. This Directive  supplements Council  Directive  89/397/EEC. 

2. This Directive  shall  apply without  prejudice  to the provisions  adopted 

In the context  of more specific Community  rules. 

- < f-

Artlcle  2 

This  Directive 

1) 

ensures  that  the  training of  the  food  control  officials  is such  th?t 

their  technical  and  administrative  competence  Is adequate; 

2) 

provides  for  generally  accepted  quality  standards  for  laboratories 

entrusted  by  the Member  states with  the official  control  of  foodstuffs 

and  the use of  validated  methods of  analysis by  these  laboratories 

whenever  possible; 

3) 

Introduces provisions  for officials of  the Commission  to cooperate 

with  the competent  author it les of  the Member  States  In carrying  out 

controls  in the  field of  foodstuffs; 

4) 

lays down  rules  for  an  administrative  mutual  aid system between  Member 

States; 

5) 

provides  for  the circulation  of  annual  reports on  the  Implementation 

of  a coordinated  programme  on  the control  of  foodstuffs whlthln th-3 

Community. 

Article  3 

Member  States shall  ensure  that  the competent  authorities  have a sufficient 

number  of  suitably  qualified  and experienced  staff, notably  in areas  such 

as chemistry,  (veterinary) médecine, microbiology,  food  hygiene, food 

processing  and  law so  that  the controls, referred  to  In article 5 of 

Council  Directive  89/397/EEC, can be  carried  out  adequately. 

-£-

Article  4 

1. 

Member  States shall  take all measures necessary  to ensure  that  the 

laboratories referred  to  In article 7 of Council  Directive 

89/397/EEC comply  with  the general  criteria  for  the operation of 

testing  laboratories  laid down  In European  standard  EN 45001 

supplemented  by Standard Operating  Procedures  and  the random  audit of 

their  compliance by quality  assurance personnel,  In accordance  with 
the OECD principles  n° 2 and 7 of good  laboratory  practice.^2* 

2. 

In assessing  the  laboratories referred  to  In article 7 of Council 

Directive  89/397/EEC Member  States shall 

a) apply  the criteria  laid down  In European  standard  EN 45002 and 

b) require  the use of proficiency  testing  schemes. 

Laboratories meeting  the assessment  criteria  shall  be presumed  to 

fulfil  the criteria  referred  to  in the  first  paragraph. 

Laboratories which  do not meet  the assessment  criteria  shall  not  be 

considered  as  laboratories  referred  to  In article 7 of  Council 

Directive 89/397/EEC. 

3. 

Member  States shall  recognize  bodies  responsible  for  the assessment  of 

laboratories as referred  to  In article 7 of Council  Directive 

89/397/EEC. These bodies shall  comply with  the genera! criteria  for 

laboratory  accreditation  bodies  laid down  In European  Standard  EN 

45003. 

Article 5 

Member  States shall  ensure  that  the methods of  analysis used  by  the 

laboratories  referred  to  In article 7 of Council  Directive  89/397/EEC 

comply  whenever  possible with  the provisions of  paragraph  1 and  2 of 
the annex of Council  Directive 85/591/EEC<3>  of  23 December  1985 con 

cerning  the  introduction of Community  methods of sampling  and  analysis 

for  the monitoring of  foodstuffs  Intended  for  human  consumption. 

(2) section  M  of Annex  2 of  the Decision of  the Council  of  the 

Organisation  for  Economic  Cooperation snd Development  of  12 May  1981 

concerning  the mutual  acceptance of data 

In  the assessment  of 

chemicals, C  (61)30  (final). 

(3) OJ  nr L 372 of  31.12.1985, p. 50 

- d P-

Artlcle  6 

1. 

The  Commission  shall  designate  specific  officials  to cooperate  with 

the competent  authorities  of  the Member  States  In the control  of  of 

foodstuffs. The Commission  shall  ensure  that  such  officials  possess 

the  technical  expertise  and  appropriate experience  to carry out  these 

controls. 

2. 

The Commission  may  request  the competent  authorities  of  the  Member 

States  to carry  out  controls  In conjunction  with  Its  specific 

officials. 

3. 

In performing  their  duties,  the Commission's  specific  officials  shall 

have  the  right  to carry  out  the operations provided  for  In Article 5 

of  Council  Directive  89/397/EEC  on  the official  control  of  foodstuffs. 

For  the purpose  of  participating  in the controls  referred  to  In 

paragraph  2, the Commission's  specific  officials  shall  produce  written 

authorisation  specifying  their  Identity  and  status. 

4. 

A Member  State  in whose  territory  controls  by  the  Commission's 

specific  officials  are  being  carried  out, shall  give  all  the  necessary 

assistance  to enable  them  to do  their work  properly. 

5. 

After  the execution  of  each  control  operation  as  referred  to  In 

paragraph  2, the Commission  shall  forward  a  report  on  the work  of  Its 

specific  officials  to  the competent  authorities of  the Member  States 

concerned;  that  communication  shall  record  any  difficulties 

encountered  or  Infringements  noted. 

- f-

Article  7 

1. 

The  competent  authorities of  the Member  States shall  afford  each  other 

administrative  assistance  In all  supervisory  procedures  In connection 

with  legal  provisions and  quality  standards  applicable  to  foodstuffs 

and  in all  proceedings  for  infringements of  the  law applicable  to 

foodstuffs. 

2. 

On  request,  the  competent  authority  concerned  shall  provide  the 

request Ing authorIty with  ail  Information  enabling  that  authority  to 

guarantee  compliance  with  legal  provisions  and  quaiIty  standards 

applicable  to  foodstuffs within  its  Jurisdiction. 

In obtaining  the  Information  requested,  the authority  requested  to 

assist  or  the authority  to which  It has delegated  responsibility  snail 

proceed  as  If  it were  acting  in discharge of  Its own  responsibilities 

or  at  the  request  of  another  authority  in  its home  country. 

3. 

The  authority  requested  to assist  shall  provide  the  requesting 

authority  with  ail  evidence  and  documents or  certified  true  copies 

thereof  which  are  In  its possession  or which  It has acquired  pursuant 

to paragraph  2 and which  may assist  the requesting  authority  in the 

conduct  of  the procedures  referred  to  in  Its request. 

4. 

The  Information  and  documents  provided  pursuant  to paragraphs  2 and  3 

shall  be  forwarded  immediately  and  through  the most  appropriate 

channels  In each  case. 

-AO-

Artlcle  8 

On  request,  the  competent  authorities  of  the Member  States  shall  afford  the 

Commission  with  the  information,  evidence  and  documents  as  referred  to  in 

article 7  paragraphs  2 and  3. 

Article  9 

1. 

Information  forwarded  pursuant  to  this Directive,  In whatever  form, 

shall  be  confidential.  Information  shall  be  covered  by  professional  or 

commercial  secrecy  and  shall  qualify  for  the protection  conferred  by 

the  national  law of  the Member  States which  received  it on  Information 

of  the  same  type  and  by  the  corresponding provisions applying  at 

Community  level. 

The  Information  referred  to  In the  first  subparagraph  may  not  In 

particular  be  transmitted  to persons  other  than  those  who,  in the 

Member  States  or  Community  Institutions,  need  to know  such  information 

for  the  purposes  of  their  work.  Nor  may  It be used  for  the  purposes 

other  than  those  provided  for  by  this  Directive,  unless  the  authority 

which  provided  It has given  explicit  consent  and  provided  that  the 

provisions  In force  in the Member  States where  the  authority  which 

received  It has  Its seat,  do not  prevent  such  notification or 

utI IIzatIon. 

2. 

This  Directive  shall  not  prevent  the use,  in the  course  of  court 

proceedings  or  prosecutions  started  subsequently  for  failure  to  comply 

with  requirements  on  foodstuffs, of  Information  obtained  pursuant  to 

this  Directive. 

3. 

The  findings  of  the  specific  officials of  the Commission  or  of  the 

competent  authorities  of  a Member  State  In the  course  of  application 

of  this Directive  may  be  Invoked  by  the  competent  authorities of  the 

-•fi-

other Member States or by the Commission, in such cases, they shall 

have no less value because of the fact that they do not come from the 

Member State In question. 

Article 10 

Once a year the Commission shall forward to the European Parliament and to 

the Council a report, containing the seperate section on  Implementation of 

the coordinated programme, contributed by each Member State, as referred to 

in article 14 paragraph 3 sub-paragraph 3 of Council Directive 89/397/EEC. 

Article 11 

Member States shall bring  Into force the laws, regulations and 

administrative provisions necessary to comply with this Directive before 

(-). 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 «hall be 

adopted by Member states. 

Article 12 

This Directive le addressed to the Member States. 

- / < ?-

impact  assessment  form 

The  Impact  of  the proposal  on  business with special  reference  to small  and 
medium  sized  enterprises  (SMEs) 

Title of  the proposal 

Draft  proposal  for  a Council  Directive  on  the subject  of  additional 
measures  concerning  the official  control  of  foodstuffs. 

Reference  Number  (Répertoire) 

The  proposal 

This proposal  which  alms at  Improving  the official  control  of  foodstuffs, 
Introduces  provisions  applicable  to the  national  food  inspection  services 
and  not  to  the  food businesses  themselves. 
Therefore  the propsosal  has no direct  impact  on  the SMEs. 

- • #-

FINANCIAL  STATEMENT 

SECTION  1; FINANCIAL  IMPLICATIONS 

1.  Title of operation 

Community  inspection service 

2.  Budget  headings  involved 

A 11: Staff  In active employment 

B8-530:  Completing  the  Internal market - Support  expenditure 

3.  Legal  basis 

Article  100a of  the Treaty 

4.  Description of operation 

4.1  Officials responsible  for Community  Inspection, as envisaged by 

Directive 89/397/EEC on  the official  control  of  foodstuffs, must  in 
general  assume  "auditing" tasks, which will  involve assistance, on  the 
one hand,  in ensuring  that Community  law  Is being correctly applied 
and, on  the other,  in resolving  problems between Member  States caused 
by the free movement of  foodstuffs  In the Community. 

4.2  Duration:  Indefinite 

4.3  Target population 

Directly  involved: bodies responsible  for  the control  of  foodstuffs  in 
the Member  States 

Indirectly  involved: economic operators  In the food sector 

5.  Classification of expenditure or  revenue 

5.1  Non-compuIsor y 
5.2  Non-differentlated, the expenditure  Involved being chiefly expenditure 

on staff 
5.3  Revenue : n M 

u-

6. 

Type of expenditure or  revenue 

6.4  On  regular or outside staff 
6.5  No 
6.6  No 

7. 

Financial  impact on appropriations for operations (Part B of  the 
budget) 

7.1  In accordance with  the scales applied by  the Commission  to outside 

staff and to the purchase of data-processing equipment. 

7.2  Up to 100%  If  It proves  impossible  to recruit  regular  staff. 

7.3  1992, with  the recruitment  of  five external  persons: 

3 A auxiIiarles 
1 B aux 11iary 
1 C auxiIIary 

Commitment  appropriations - payment  appropriations 

284 550 - 284 550 

8. What  anti-fraud measures are planned  in the proposal  for  the operation? 

Not applI cab le 

Section 2: Administrative expenditure (Part A of  the budget) 

1.  Will  the proposed operation  Involve an  Increase  In the number of 

Commission staff? 

Yes 

15 A officials 

2 B officials 
3 C officials 

This assessment  of  required  staff  Is based on the  following 
considerations.  In order  to ensure  the success of  the audits of 
national  inspection arrangements  two officials are needed: one from 
the Member  State which  is the subject of  the audit, and who  therefore 
has basic knowledge of  the authorities of his country, and  the other 
from a different  Member  State, to ensure  total  impartlalIty.  Where 
the mission  involves the settlement  of  a dispute between Member 
States, three officials will  be needed:  two with  a good knowledge of 
the systems of  the Member  States concerned  and a third  to act  as 
Impartial mediator. 

The missions themselves will  last  two weeks, though  it may  take two 
months to prepare and draw up  the report. 

-  is-. 

Similar working methods are already  being used by  the Commission's 
other  inspection services, which employ  between  15 and  20  inspectors. 

These officials will  be recruited gradually.  Five are to be  recruited 
in 1992, five  In 1993 and  five  in 1994. 

The required staff  are to be found either  by  Internal  redeployment or 
under  the annual  budget  procedure. 

2. 

Indicate the amount of staff and administrative expenditure  Involved 
In the proposed operation.  Explain  the method of calculation. 

Where regular  staff  are  involved, the costs are assessed  by DG  IX. 

Where outside staff  are  Involved, the Commission's current  scales have 
been used. 

Section 3: Elements of cost-effectiveness analysis 

1.  Objectives and coherence with  financial  programming 

1.1  Completion of  the  internal  market  In the food sector will  be effective 

only when  the national  Inspections are considered  equivalent  in each 
Member  State and are recognized  as such by all  the Member States. 
Even though  the Member  States remain responsible  for  the control  of 
foodstuffs, the Commission has a key  role to play  In this area, e.g. 
by checking  that  the  Inspections are performed  to a high standard  and 
putting  the authorities  responsible  for control  in the various 
Member  States  in contact with each other, and possibly  acting as 
mediator  in cases of dispute. 

1.2  Yes 

1.3  The principal  objective  falls within  the overall  objective of 

completing  the  Internal  market  and more generally within  the  framework 
of ensuring  the uniform  application of Community  law. 

- // 

2. 

Grounds for  the operation 

Similar objectives could be attained  by setting up a  "Food Agency", 
though  this approach  has been rejected, since the proliferation of 
such bodies  is politically undesirable.  Moreover, even  though  it is 
hard to put an exact  figure on  the cost of setting up a new agency, it 
would undoubtedly  be greater  than  that of recruiting  15 officials. 

Lastly,  in view of  the auditing duties to be entrusted  to these 
officials,  It  is better  for  them  to be completely  Independent of  the 
Member States. 

Moreover, similar  arrangements exist  In other  food sectors, such as 
fisheries, fresh meat, etc. 

3.  Monitoring and evaluation of  the operation 

3.1  - Number of audit  reports 

-  Number of settlements of disputes between Member  States 

3.2  A work programme will  be finalized at  the beginning of each year. 

This will  then be evaluated  and set  down  in a report.  The report will 
be used  to draw up  the following  year's work programme. 

3.3  The chief causes of uncertainty  are, firstly, whether  it will  actually 

be possibile to recruit  the necessary  staff and, secondly, the extent 
to which  the national  bodies responsible  for  the control  of  foodstuffs 
wiI I cooperate. 

ISSN 0254-1475 

COM(91) 526 final 

DOCUMENTS 

EN 

10 

Catalogue number : CB-CO-91-594-EN-C 

ISBN92-77-78962-X 

Office for Official Publications of the European Communities 
1^2985 Luxembourg