Source: EURLEX
Language: en
Format: md

**COMVIISSION OF THE EUROPEAN COMMUNITIES**

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                         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

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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

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**`concerning the`** **`mutual`** **`acceptance of data`** _**In**_ **`the`** **`assessment`** **`of`**

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  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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**ISSN 0254-1475**

###### **COM(91) 526 final**

## **DOCUMENTS**

##### **E N 10** **Catalogue number : CB-CO-91-594-EN-C** **ISBN92-77-78962-X**

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