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) 
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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. 
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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. 
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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. 
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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. 
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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. 
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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 
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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. 
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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. 
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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 
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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. 
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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. 
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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 
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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. 
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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. 
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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. 

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COM(91) 526 final 
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