CELEX: 51991PC0526
Language: en
Date: 1992-02-06
Title: Proposal for a COUNCIL DIRECTIVE ON THE SUBJECT OF ADDITIONAL MEASURES CONCERNING THE OFFICIAL CONTROL OF FOODSTUFFS

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)
 ---pagebreak---                                      -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.
 ---pagebreak---                                     -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.
 ---pagebreak---                                        §-
                                   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.
 ---pagebreak---                                     -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
 ---pagebreak--- 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.
 ---pagebreak---                                      -<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.
 ---pagebreak---                                     -£-
                                  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
 ---pagebreak---                                   -dP-
                                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.
 ---pagebreak---                                   -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.
 ---pagebreak---                                     -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
 ---pagebreak---                                      -•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.
 ---pagebreak---                                        -/<?-
                           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.
 ---pagebreak---                                       - • # -
                            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
 ---pagebreak---                                     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.
 ---pagebreak---                                    - 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.
 ---pagebreak---                                    - / /
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.
 ---pagebreak---  ---pagebreak---                                                                      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