CELEX: 51993PC0510
Language: en
Date: 1993-10-21
Title: Proposal for a COUNCIL DIRECTIVE fixing the principles governing the organisation of inspections in the field of animal nutrition

COMMISSION OF THE EUROPEAN COMMUNITIES
                                     COM(93) 5 10 f mal
                                     Brussels, 2 1 October 1993
                      Proposal for a
                    COUNCIL DIRECTIVE
              fixing the principles governing
          the organisation of inspections in the
                 field of animal nutrition
              (presented by the Commission)
 ---pagebreak---                                  - y\ -
                          EXPLANATORY MEMORANDUM
The purpose of this proposal is to lay down at Community level the
principles governing the organization of inspections in the field of
animal nutrition.
Experience gained since the adoption of the basic directives in this
sector has shown that close collaboration is needed between Member
States with regard to inspections if the internal market is to operate
smoothly. Animal nutrition is the largest of all livestock sectors,
accounting for more than 60% of agricultural income in the Community.
A framework of Community rules on the organization of official
inspections in this sector is necessary given the considerable economic
importance of feedingstuffs, the importance of scientific, technical and
administrative aspects and the requirements of free movement of goods,
as well as the need to protect human and animal health.
Given the particular situation with regard to animal nutrition, it seems
advisable to lay down more detailed rules for implementing official
inspections of feedingstuffs than those for official inspection of
foodstuffs under Council Directive 89/397/EEC. In this context, in
particular, account must be taken of potential danger to the health of
consumers of animal products (e.g. the dangers linked to the use of raw
materials containing undesirable substances such as heavy metals or the
illegal use of substances in animal fattening).
With this in mind, the primary objective of this draft proposal is to
create a climate of mutual confidence between Member States so that
inspections can be kept to the strict minimum required to safeguard
health.
The proposal is based on the following principles.
1. All products    and substances used    in animal  nutrition   should be
   covered.
2. Certain general principles are introduced (equivalence, regularity
   and proportionality of inspections) (Articles 3 and 4).
3. Systematic documentary and identity checks and random physical checks
   on imports from third countries (Articles 5 to 7 ) .
4. Intensified inspections at the place of origin and checks at the
   destination within the framework of the internal market (Articles 8
   to 11).
5. Establishment of cooperation between the Member           States where
    infringements are discovered      (Articles 12 and      13) and the
    introduction of checks on holdings (Article 14).
6. Provision is made for measures to be taken after inspections, the
   settlement of disputes and protective measures (Articles 6, 11 and 15
   to 19).
 ---pagebreak--- 7. Recommendations concerning    inspection programmes coordinated at
   Community level and the freedom of Member States regarding actual
   implementation (Articles 21 and 22).
It should be noted that a great deal of latitude has been left for
national   measures. The   principle   of   subsidiarity  is  therefore
respected, since the rules provide above all a framework within which
the Member States are free to make their own arrangements regarding the
implementation of checks.
 ---pagebreak---                                      - 2 -
                               Proposal for a
                              COUNCIL DIRECTIVE
                       fixing the principles governing
                   the organisation of inspections in the
                          field of animal nutrition
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing    the European Economic    Community,
and in particular Article 43 thereof,
Having regard to the proposal from the Commission^ 1 ),
Having regard to the opinion of the European Par Iiament^ 2 ),
Having regard to the opinion of the Economic and Social Committee^ 3 ),
Whereas animal  nutrition has become a very    important aspect of    Community
agr iculture;
Whereas fixing at Community level the principles governing the organization
of official inspections in the field of animal nutrition helps safeguard
public and animal health and protect the interests of consumers;
Whereas detailed rules must be laid down for the organisation of official
inspections of feedingstuf fs in view of the very wide range of products
used, the large volume of consignments of goods commercially traded, the
integrated structure of the sector and, in particular, the need to ensure
both the wholesomeness of the feedingstuff to be consumed by animals and the
quality of the foodstuff;
Whereas, in order to attain the desired objective, the rules laid down in
this Directive must cover all products and substances used in animal
nutrition   in the Community; whereas      inspections should therefore be
organized to cover products imported into or marketed in the Community-,
Whereas, to be effective, inspections must be carried out regularly; whereas
they must not be restricted as to the subject, stage or moment at which they
are carried out; whereas they must take the most suitable forms to ensure
their effectiveness;
Whereas, in order to ensure that inspection procedures are not evaded, it is
necessary to provide that Member States shall not exclude a product from
appropriate inspection on the grounds that it is intended for export outside
the Community;
Whereas products from third countries must be subject       to documentary  and
identity checks on entry into the Community territory;
Whereas principles should be laid down to govern the organization of and
steps to be taken following the physical checks to be carried out by the
competent authorities; whereas, in this context, the issue of a certificate
stating that checks have been carried out is justified;
  (1) OJ No
  (2) OJ No
  (3) OJ No
 ---pagebreak---                                     - 3 -
Whereas, with regard to intra-Communlty trade, emphasis should be placed on
the checks to be carried out at the place of dispatch and in limiting those
that could be carried out at the destination with a view to eliminating
checks at the Community's internal borders;
Whereas this solution requires greater confidence in the inspections carried
out by the Member State of dispatch; whereas the dispatching Member State
must ensure that such checks are carried out in an appropriate fashion;
Whereas, in the Member State of destination, spot checks could be carried
out at the place of destination; whereas, however, in the event of
presumption of irregularity, the check could, exceptionally, be carried out
while the products are in transit;
Whereas provision should be made for action      to be  taken where  a check
discloses that a consignment is irregular;
Whereas provision should be made for a procedure to settle disputes which
may arise concerning consignments;
Whereas provision must be made for protective measures*, whereas, for reasons
of effectiveness, such measures should primarily be the responsibility of
the Member State of dispatch; whereas the Commission must be able to take
action, particularly by making on-the-spot visits and adopting measures
appropriate to the situation;
Whereas, although undertakings should not have the right to oppose
inspections, their legitimate rights must nevertheless be preserved, in
particular the right to manufacturing secrecy and the right of appeal;
Whereas the authorities responsible for inspections may differ from one
Member State to another; whereas it is therefore desirable to publish a list
of the competent authorities in the field in each Member State, with an
indication of the territories for which they are competent and the
laboratories authorized to carry out analyses in connection with such
inspect ions;
Whereas, although it is primarily for the Member States to lay down their
inspection programmes, it is necessary, with a view to the proper
functioning of the internal market, to arrange also for coordinated
programmes at Community level;
Whereas the Commission should be entrusted the task of adopting measures for
applying this Directive,
HAS ADOPTED THIS DIRECTIVE:
 ---pagebreak---                                     - 4 -
                                  Article 1
1. This Directive fixes the principles governing         the   organisation  of
   inspections in the field of animal nutrition.
2. This Directive shall apply without prejudice to:
   -  the Community customs rules,
   -  the Community rules on safeguard measures.
                                  Art icle 2
1  For the    purposes  of this  Directive   the following   definitions  shall
   apply:
   a) "official inspection in the field of animal nutrition", hereinafter
      called "inspection" means an inspection by the competent authorities
      of the compliance, in particular, of:
      -   raw mater ials,
      -   straight feedingstuffs,
      -   compound feedingstuffs,
      -   feedingstuffs intended for particular nutritional purposes,
      -   additives used in animal nutrition,
      -   si I age agents,
      -   certain products used in animal nutrition
      with provisions aimed at preventing risks to public and animal
      health, guaranteeing fair commercial       transactions or protecting
      consumer interests, including provisions on consumer information.
   b) "documentary check" means verification of the documents accompanying
      a product;
   c) "identity check" means verification, by visual inspection only, for
      consistency between the documents, the labelling and the products-,
   d) "physical check" means a check of the product           itself, possibly
      including sampling and laboratory testing;
   e) "import" means the entry of products from third countries into the
      customs territory of the Community;
   f) "importer" means any natural or legal person who presents products
      for importation into the Community;
   g) "product" means feedingstuffs and all substances used in animal
      nutr it ion;
 ---pagebreak---                                         - 5 -
    h) "competent authority" means the central authority of a Member State,
        empowered to carry out checks, or any authority to which it has
        delegated such powers;
    I) "establishment" means any undertaking which produces, manufactures,
        stores, processes or packaging products;
2.  The definitions given in the Community legislation relating to the field
    of animal nutrition apply where appropriate.
                                      Art icle 3
1.  Member States shall take all the necessary measures to ensure         that
    inspections are carried out in accordance with this Directive.
2.  Member States shall not exclude a product from appropriate inspection on
    the grounds that it is intended for export outside the Community.
                                      Art icle 4
1.  Inspections shall be carried out :
    a) at regular intervals;
    b) where non-compliance is suspected.
2.  Inspections shall be carried out using means proportionate to the
    desired objective, particularly by means of auditing systems based on
    r i sk ana lysis.
3.  Inspections shall cover all stages of production, manufacture, import,
    processing, storage, transport, distribution and marketing of these
    products.
    They shall also cover uses prohibited in relation to animal nutrition.
4.  As a general      rule,   inspections   shall be carried out without prior
    warning.
5.  The competent authority shall, in each case, select the stage or stages
    as listed in paragraph 3 most appropriate for the intended purpose of
    the inspection.
                                      CHAPTER I
                            IMPORTS FROM THIRD COUNTRIES
                                      Article 5
Notwithstanding Article 4(1), Member States shall take all the necessary
steps to ensure that imported products are subjected by the competent
authorities to a documentary and identity check in order to verify:
    -   their nature,
    -   their origin,
    -   their geographical destination.
 ---pagebreak---                                        6 -
                                   Article 6
1. Member States shall ensure the conformity of products by means of random
   physical checks.
2. Where the checks show that products do not meet the conditions laid down
    in Article 1(2), Member States shall prohibit their importation into and
   order their redispatch out of the Community territory.
3. However, before taking this step, the competent authorities may, if
   circumstances permit, allow the Importer or his representative the
   cho i ce
   (a)     in the case of serious infringements:
          - of destroying the products in the territory of the Member State
             where the check was carried out;
          - of using the products for other purposes;
          - of decontaminating them where appropriate;
   (b)     in the case of minor infringements:
          - of regularizing the position within a deadline to be determined.
4. The costs incurred in the redispatch, destruction, decontamination or
   use for other purposes of the products shall be borne by the importer or
   his representative.
                                   Article 7
1. Where the competent authority decides to reject products, it shall
   inform the Commission and the other Member States of its decision,
   indicating the infringements found.
2. In order to avoid the duplication of checks in the Member State of
   destination, where products are not         intended to be released for
   circulation in the territory of the Member State where the check was
   carried out, the competent authority which performed the physical check
   shall provide the person concerned with certificates indicating the type
   of check carried out and its outcome. Commercial documents shall contain
   a reference to this certificate.
   However, the right of the Member State of destination       to carry out
   random chacks on products shall not be affected.
3. For the purposes of p&ragraph 2, a standard certificate shall be adopted
   in accordance with the procedure laid down in Article 24 before 1
   January 1995.
 ---pagebreak---                                       - 7 -
                                   CHAPTER II
                          TRADE WITHIN THE COMMUNITY
                                    Article 8
Member States shall take all necessary measures to ensure that products
intended for dispatch to another Member State are inspected with the same
care as those intended for marketing on their own territory.
                                    SECTION I
                                CHECKS AT ORIGIN
                                    Art icle 9
1.  Exporting Member States shall ensure that the competent authority
    carries out checks on establishments in order to satisfy itself that
    they meet their obligations under the Community rules and that products
     intended for trade comply with Community requirements.
2.  Where there are grounds for suspecting that requirements are not being
    met, the competent authority shall carry out the necessary checks and,
     if the suspicion is confirmed,, take the appropriate measures.
                                   SECTION M
                           CHECKS AT THE DESTINATION
                                   Article 10
1.  The competent authority of the Member State of destination may, at
    places of destination, check the compliance of products by means of non-
    disciminatory random checks.
2.   In addition, where the competent authority of the Member State of
    transit or the Member State of destination has information leading it to
    suspect an infringement, checks may also be carried out during the
    transport of products in its territory.
 ---pagebreak---                                         8 -
                                   Article 11
1.   If, during a check carried out at the place of destination of a
    consignment or during transport, the competent authorities of a Member
    State establish the non-compliance of the products, they may, where
    circumstances permit, give the consignor, the receiver or any other
    person so entitled, the choice:
     (a)   in the case of a serious infringement:
          - of destroying the products,
          - of using the products for other purposes, including returning
             them with the authorization of the competent authority of the
             country of the establishment of origin, or
          - of decontaminating them where applicable;
    (b)    in the case of a minor infringement:
          - regularizing the situation within a deadline to be determined.
2.  The costs incurred in the redispatch, destruction, decontamination or
    use for other purposes of the products shall be borne by the consignor,
    the receiver or any other person so entitled.
                                  SECTION M l
                     COOPERATION IN CASES OF INFRINGEMENT
                                  Article 12
In the cases provided for in Article 11, the competent authority of the
Member State of destination shall contact the competent authorities of the
Member State of dispatch without delay. The latter authorities shall take
all necessary measures and notify the competent authority of the former
Member State of the nature of the checks carried out, the decisions taken
and the reasons for such decisions.
If the authority of the Member State of destination fears that such measures
are inadequate, the competent authorities of the two Member States shall
together seek ways and means of remedying the situation; if appropriate this
may involve an on-the-spot inspection.
Where the checks provided for in Article 11 show repeated irregularities,
the competent authority of the Member State of destination shall inform the
Commission and the competent authorities of the other Member States.
 ---pagebreak---                                       - 9
                                   Article 13
1.  The Commission, at the request of the competent authority of the Member
    State of destination or on its own initiative, and taking into account
    the nature of the infringements established, may :
    -   send representatives, after informing the authorities of the Member
        State concerned and after inviting the competent authorities of that
        Member State to accompany them or after receiving an invitation from
        the said authorities,
    -   request the competent authority to intensify       its  checks  on  the
        products of the establishment concerned.
2.   It shall inform the Member States of its findings.
    Pending the Commission's findings, the Member State of dispatch must, if
    so requested by the Member State of destination, intensify checks on
    products coming from the establishment in question.
    The Member State of destination may, for its part, intensify checks on
    products coming from the same establishment.
3.  Without delay the Commission shall review the situation within the
    committee referred to in Article 23. It may adopt the necessary
    decisions in accordance with the procedure laid down in Article 25;
     including those relating to intra-Community movements of products.
                                   SECTION IV
                            INSPECTIONS ON HOLDINGS
                                  Article 14
Member States shall ensure that the competent authority has access to places
where agricultural production      is carried   in order to check that the
conditions for production and use of products are complied with.
                                  CHAPTER I I I
                              GENERAL PROVISIONS
                                  Article 15
1.  Member States shall ensure that inspections are carried out in such a
    way that delays in the delivery of products are minimized and that
     inspections do not result in unjustified obstacles to the marketing
    thereof.
2.  They shall provide that officials responsible      for  controls  shall  be
    subject to professional confidentiality.
 ---pagebreak---                                      -• 10 -
                                   Article 16
 1.  Products may be sampled for the purpose of analysis.
     Member States shall adopt the provisions necessary:
     -   to ensure that those   subject   to checks are entitled   to a second
        op i n i on ;
     -   to preserve samples;
2.  Analyses shall be carried out by official    laboratories.
    Member States may also authorize other      laboratories to carry out such
    analyses.
3.  Member States shall ensure that sampling and analysis are carried out in
    accordance with Community rules.
    However, in the absence of Community rules and methods, Member States
    shall take the necessary steps to ensure that inspections are carried
    out :
        in accordance with standards recognized by international bodies;
    -    in the absence of such standards, in accordance with national rules
        which comply with the general principles of the Treaty.
4.  Detailed rules for the application of this Article shall be adopted in
    accordance with the procedure laid down in Article 24.
                                  Article 17
Member States shall adopt the appropriate laws or administrative measures to
penalize any infringement of Community rules by natural or legal persons
where it is found that Community rules have been infringed.
                                   Article 18
Rights of appeal existing under the laws in force in the Member States
against decisions by the competent authorities shall not be affected by this
Direct iva.
Decisions taken by the competent authority and the reasons for such
decisions shall be notified to the operator concerned by such decisions or
his representative.
If the operator concerned or his representative so requests, the said
decisions and reasons shall be communicated to him in writing with details
of the rights of appeal which are available to him under the law in force in
the Member State performing the checks and of the procedure and time limits
applI cable.
 ---pagebreak---                                     - 11 -
                                 Article 19
1.   In the case of dispute between two Member States or between a Member
    State and an operator established in another Member State the two
    parties concerned may, if they so agree, within a maximum period of one
    month, submit the dispute for the assessment of an expert whose name
    appears on a list of Community experts to be drawn up by the Commission.
2.  Detailed rules for the application of this Article shall be adopted in
    accordance with the procedure laid down in Article 24.
                                  Article 20
Each Member State shall communicate to the Commission:
    the competent authority or authorities, their geographical coverage and
    their sphere of competence,
    the laboratory or laboratories approved by the competent authorities and
    responsible for carrying out analyses connected with the inspections.
These lists shall be published   in the C Series of the Official  Journal of
the European Communities.
                                  Article 21
Member States shall assign a central department or body to coordinate
implementation of the inspections provided for in this Directive. In
particular, that department or body shall be responsible for:
    drawing up the plans enabling the competent departments to carry out the
    required inspections,
    coordinating the activities of regional departments responsible for
    carrying out inspections,
    collecting the results of those inspections and the data which must be
    sent to the Commission.
                                  Article 22
1.  Member States shall draw up a plan setting out the national measures to
    be taken to achieve the aim of this Directive.
    These plans must take into account the specific situation of each Member
    State and specify the type and frequency of the inspections, which must
    be performed regularly.
 ---pagebreak---                                      - 12 -
 2.  Before 30 November each year, the Member States shall transmit to the
     Commission all relevant information concerning the implementation of the
     plans referred to in paragraph 1 during the previous year, specifying:
     -   the criteria used in drawing up the plans;
     -   the number and type of inspections carried out;
    -    the number and type of infringements found.
3.  Before 30 November each year, and before 30 November 1995 for the first
     time, the Commission shall make a recommendation to the Member States,
    after    having   consulted  them within     the  Standing   Committee  for
     Feedingstuffs, concerning a coordinated inspection programme for the
     following year. This recommendation may be amended at a later date as
     required by the implementation of the coordinated programme.
    The coordinated programme shall indicate, in particular,       the priority
    criteria to be followed for its implementation.
    The information provided for in paragraph 2 shall contain a separate
    section specifically concerning       implementation of the coordinated
    programme.
                                   Article 23
The    Commission   shall   be  assisted   by   the  Standing    Committee  for
Feedingstuffs, set up by Council Decision 70/372/EEC of          20 July 1970,
hereinafter referred to as "the Committee".
                                   Article 24
Where the procedure laid down in this        Article  is  to  be  followed, the
following provisions shall apply:
The representative of the Commission shall submit to the Committee a draft
of the measures to be taken. The Committee shall deliver its opinion on the
draft within a time limit which the chairman may lay down according to the
urgency of the matter, if necessary by taking a vote.
The opinion shall be recorded in the minutes-, in addition, each Member State
shall have the right to ask to have its position recorded in the minutes.
The Commission shall take the utmost account of the opinion delivered by the
Committee. It shall inform the Committee of the manner in which its opinion
has been taken into account.
                                   Article 25
Where the procedure laid down in       this  Article  is  to  be  followed, the
following provisions shall apply..
The representative of the Commission shall submit to the Committee a draft
of the measures to be taken. The Committee shall deliver its opinion on the
draft within a time limit which the chairman may lay down according to the
urgency of the matter.
 ---pagebreak---                                        13 -
The opinion shall be delivered by y he majority laid down in Article 148(2)
of the Treaty in the case of decisions which the Council is required to
adopt on a proposal from the Commission. The votes of the representatives of
the Member States within the Committee shall be weighted in the manner set
out in that Article. The Chairman shall not vote.
The Commission shall adopt the measures envisaged if they are in accordance
with the opinion of the Committee.
 If the measures envisaged are not in accordance with the opinion of the
Committee, or if no opinion is delivered, the Commission shall without delay
submit to the Council a proposal relating to the measures to be taken. The
Council shall act by a qualified majority.
If, on   the expiry of a period to be specified in each act adopted by the
Council    pursuant to this paragraph but which may under no circumstances
exceed   three months from the date of referral to the Council, the Council
has not   acted, the Commission shall adopt the proposed measures.
                                   Article 26
1.  Member States shall bring into force the laws, regulations and
    administrative provisions necessary to comply with this Directive not
     later than 1 January 1995. They shall forthwith inform the Commission
     thereof. The provisions adopted shall apply from 1 January 1995.
    When these measures are adopted by the Member States, they shall contain
    a reference to this Directive or shall be accompanied by such reference
    on the occasion of their official publication. The methods of making
    such a reference shall be laid down by the Member States.
2.  Member States shall communicate to the Commission the text of the
    provisions of national law which they adopt in the area covered by this
    Direct ive.
                                   Article 27
This Directive is addressed to the Member States.
Done at
                                                   For the CounciI
                                                   The President
 ---pagebreak---                                                                      ISSN 0254-1475
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