CELEX: 51993PC0587
Language: en
Date: 1993-11-26
Title: Proposal for a COUNCIL REGULATION (EEC) laying down the conditions and arrangements for approving certain establishments operating in the animal feed sector and amending Directives 70/524/EEC and 74/63/EEC

COMMISSION OF THE EUROPEAN COMMUNITIES
                                          C0M(93) 587 final
                                          Brussels, 26 November 1993
                          Proposa I for a
                    COUNCIL REGULATION (EEC)
          laying down the conditions and arrangements
              for approving certain establishments
              operating in the animal feed sector
       and amending Directives 70/524/EEC and 74/63/EEC
                  (presented by the Commission)
 ---pagebreak---                                        -I-
                              Explanatory Memorandum
The draft Council Regulation forms part of the general Community rules and
regulations on animal feed and, more particularly, the scheme to register
manufacturers and their representatives.
At  matters    currently   stand,  various     directives   lay  down   the  minimum
conditions    that   manufacturers   of   additives,    premixtures    and  compound
feedingstuffs must observe.
Thus,   Council   Directives   70/524/EEC    on  additives   in  feedingstuffs   and
74/63/EEC on undesirable substances and products in feedingstuffs restrict
the use and handling of certain materials and products only to those persons
with   the  qualifications,   facilities    and   equipment  deemed   necessary  for
general safety.
In the light of the experience gained, and in the context of the operation
of the single market, it is proposed:
      to ensure legal clarity and to improve transparency by setting out the
     conditions     and   arrangements    applying    to   the   approval   of   the
      establishments in question;
      to   update     and   supplement     the    criteria    that   manufacturers,
      intermediaries and their possible representatives must meet;
      to amend Directives 70/524/EEC and 74/63/EEC in accordance with the
      provisions of this draft Regulation.
As regards    subsidiarity, it should be noted that the Member states are
required to manage the procedures for granting and withdrawing approval and
to ensure that the obligations laid down are met.
 ---pagebreak---                                    -, 2 -
As in other cases where highly scientific or technical annexes relating to
animal or human health are updated, provision should be made for close
cooperation between the Member States and the Commission   in the Standing
Committee on animal feed established by the Council Decision 70/372/EEC of
20 July 1970, so that the annex can be amended in line with scientific and
technical  progress.
 ---pagebreak---                                          3
                                Proposal for a
                          COUNCIL RFfilllATION fFFfM
                  laying down the conditions and arrangements
                      for approving certain establishments
                      operating in the animal feed sector
               and amending Directives 70/524/EEC and 74/63/EEC
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 proposai 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   Council   Directive    70/524/EEC   of  23  November  1970  concerning
                              (4)
additives   in feedingstuffs      , as last amended by Directive 93/    /EEC ( 5 ) ,
lays down the minimum conditions to be met by manufacturers of additives,
premixtures and compound feedingstuffs containing such products;
Whereas   this  legislation   restricts    the manufacture  and  use of  certain
categories of additives, premixtures and compound feedingstuffs containing
such additives and premixtures to those manufacturers who are included on a
nat ional Iist;
(1)
(2)
(3)
(4) 0J No L 270, 14.12.1970, p. 1.
(5)
 ---pagebreak---                                         -v-
Whereas with the operation of the single market in mind, some optional
provisions   which   still   allow   the  Member   States   to  derogate  from  the
Community provisions applying to the sector in question and to specify the
criteria for approving manufacturers should be abolished so as to avoid
distortions    of   competition    caused   by   the   Member   States'   different
applications and interpretations of already existing approval conditions and
to  prevent   any  potentially    adverse  effects   on   animals, humans   or  the
environment, given the risks inherent in using certain additives.
whereas,   to   govern   the   presence   of   certain   particularly   undesirable
substances in feedingstuffs, Council Directive 74/63/EEC of 17 December 1973
on the fixing of maximum permitted levels for undesirable substances and
products in feedingstuffa(&), as last amended by Directive            93/../EEC( 7 ),
limits their presence in raw materials to an acceptable level; whereas this
Directive also restricts the use of these raw materials to those persons who
have the necessary qualifications, facilities and equipment for the dilution
operations which ensure that the maximum levels laid down in the Directive
as regards the various types of compound feedingstuffs are complied with;
Whereas, in the light of the experience gained, additional rules should be
laid down relating to the registration of establishments engaged             in the
manufacture, storage or packaging of the products            in question, and the
recording of other persons in an official register;
whereas, with a view to ensuring the quality of the product and preventing
the risk of residues of certain additives in animal products or of high
levels of heavy metals or pesticides which might result in the defective
manufacture of the additives, premixtures or compound           feedingstuffs, the
intention   is to approve all manufacturers of additives, premixtures and
compound feedingstuffs on the basis of standard, specific criteria;
(6) 0J No L 38, 11.2.1974, p. 31.
(7)
 ---pagebreak---                                        -s-
Whereas the obligation on all manufacturers to obtain approval will provide
the Member States with the opportunity to monitor them and possibly uncover
and   act  against   those  making   illegal use  of  authorized    substances   or
employing banned substances such as hormones or p-agonists;
Whereas the standard obligations which must be complied with to qualify for
approval should be laid down; whereas it is also necessary to give the
Commission the task of adopting detailed rules for the application of this
Regulation, including the imposition of appropriate penalties;
Whereas,   should the Council confer on the Commission responsibility           for
implementing   the rules laid down on the conditions and arrangements for
approving   the establishments    in question, provision    should    be made   for
close cooperation between the Member States and the Commission within the
Standing     Committee      for    Feedingstuffs    established      by     Council
Decision 70/372/EEC<8);
Whereas   to  ensure   greater  transparency  the  conditions   and   arrangements
relating to approval in the animal feed sector should be brought together in
a single text; whereas this entails adapting existing legislations;
Whereas the Member states are responsible for ensuring that the minimum
conditions for national authorities to grant approval as set out in this
Regulation   are met and that the establishments       subsequently    continue to
comply with the said conditions; whereas, however, these provisions must
apply without prejudice to the Community rules governing the organization of
official checks on animal feed;
Whereas it is necessary to adopt these measures at Community level in order
to better achieve the objectives of guaranteeing the quality and safety of
animal feedingstuffs,
 (8) OJ No L 170, 3.8.1970, p. 1
 ---pagebreak---                                        - y -
HAS ADOPTED THIS REGULATION:
                                     Article 1
1.   This Regulation lays down the conditions and arrangements for approving
     certain   categories   of   establishments    in  the  animal   feed   sector,
     hereinafter   referred   to   as   "establishments",  which   must   meet  the
     conditions laid down in Article 3 below with a view to the marketing of
     the products in question.
2.   This  Regulation   shall    apply    without  prejudice   to   the   Community
     provisions concerning the organization of official checks on animal
     feed.
3.   For the purposes of this Regulation, the definitions            laid down in
     Community legislation on animal feed shall apply where necessary.
                                     Article 2
From  .../.../19..., the establishments       shall apply   for  inclusion   in an
official register held by the competent national authority with a view to
being approved by the Member State.
                                     Article 3
1.   To be approved by the competent national authorities an establishment
     (a)     manufacturing    additives must meet      the conditions    listed  in
             Chapter I of the Annex;
     (b)     engaged in the manufacture, storage or packaging of premixtures
             must meet the conditions listed in Chapter II of the Annex;
     (c)     engaged in the manufacture, storage or packaging of compound
             feedingstuffs containing premixtures must meet the conditions
             listed in Chapter III A of the Annex;
     (d)     manufacturing     compound     feedingstuffs   from   raw    materials
              (ingredients) containing high levels of undesirable products or
             substances must meet the conditions listed in Chapter III B of
             the Annex;
 ---pagebreak---                                      -}-
      (e)    manufacturing compound feedingstuffs must meet the conditions
             listed in chapter III C of the Annex.
2.   The  amendments   that  need  to   be  made  to  the  Annex   by  virtue  of
     scientific and technological progress shall be adopted in accordance
     with the procedure laid down in Article 11.
                                   Article 4
Article 1 notwithstanding, manufacturers of compound feedingstuffs who use
premixtures  or   raw   materials   containing   high   levels   of   undesirable
substances and products with a view to their proper consumption may apply
for approval in accordance with this Regulation.       To be eligible for such
approval, they must meet the conditions laid down in Article 3(1)(c) or (d)
and set out in Chapters IIIA or IIIB, with the exception however of the
requirements laid down in point 7.
                                   Article 5
Where the additive    is an antibiotic, coccidiostat      or another    medicinal
substance listed in Groups A or D of the Annexes to Directive 70/524/EEC and
already authorized for manufacture as a veterinary medication within the
meaning of Article 24 of Directive 81/851/EEC, the conditions laid down in
Article 3(1)(a) and contained in chapter I of the Annex to this Regulation
shall not apply, with the exception however of the requirements stipulated
in points 3, 5, 6.2 and 7.
                                   Article 6
1.   For each activity, the competent national authority shall enter the
     establishments in the official register referred to in Article 2 under
     an individual registration number which identifies them, once it has
     established   that  they   satisfy   the  conditions   laid  down   by  this
     Regulation.
 ---pagebreak---                                       -s -
2.   The Member States shall update the official register and correct or
     replace, where necessary, any entry where an establishment decides to
     engage in activities which are in addition to or replace those for
     which it was initially registered.
                                    Article 7
The  practical   arrangements   for   approving   establishments  located  in   a
non-member   country    and   putting    animal   feedingstuffs,  additives    or
premixtures  into   circulation   within   the  Community  shall be  adopted   in
accordance with the procedure laid down in Article 11.
                                    Article 8
Each Member State shall publish each year, and by 30 November at the latest,
a list of the establishments and representatives approved in accordance with
Articles 3 and 7 which it has found to comply with the requirements listed
in the Annexes hereto.
The Member state shall send the list to the other Member States and to the
Commission before 31 December of each year.
Any amendments made to the lists after 30 November          shall be separately
notified to the other Member States and to the Commission.
                                    Article 9
Detailed rules for the application of this Regulation shall be adopted in
accordance with the procedure laid down in Article 11.
                                    Article 10
The   Commission   shall    be   assisted    by   the  Standing  Committee    for
Feedingstuffs, established by Council Decision 70/372/EEC of 20 July 1970,
hereinafter referred to as "the Committee".
 ---pagebreak---                                     -    <\-
                                  Article 11
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 depending on the
urgency of the matter, with a vote being taken, where appropriate.
The opinion shall be recorded in the summary record.            Each Member State
shall also have the right to request that its position be recorded in the
summary record.
The Commission shall take full note of the Committee's opinion.           It shall
inform the Committee of the way in which it took account thereof.
                                 Article 12
Council Directive 70/524/EEC of 23 November 1970 concerning additives in
feedingstuffs is hereby amended as follows:
1.   Article 13(1) is replaced by the following:
     "1.     Member states shall require that antibiotics, coccidiostats and
             other medicinal substances, growth promoters, trace elements
             and  vitamins  listed    in   Annex   I  or   Annex  II,  premixtures
             prepared from these additives with a view to being incorporated
             in compound feedingstuffs and compound feedingstuffs containing
             these premixtures may only be put on the market under the
             conditions  referred   to    in   the   Annex   to  Regulation  (EEC)
             No .../...  and in particular only if they have been produced
             by manufacturers who have been approved in accordance with the
             provisions of the said Regulation."
2.   The reference to Annex III in Article 13(2) is replaced by a reference
     to the Annex to Regulation (EEC) No .../...
3.   Article 13(3) is deleted.
 ---pagebreak--- 4.   Paragraph 4 of Article 13 becomes paragraph 3.
5    Article 13(5) is deleted.
6.   Annex III is deleted.
                                    Article 13
council Directive 74/63/EEC of 17 December 1973 on the fixing of maximum
permitted levels for undesirable substances and products in feedingstuffs is
hereby amended as follows:
Point (a) of Article 3a(2) is replaced by the following:
"(a) it  is  intended   for use by manufacturers     of compound  feedingstuffs
     entered  on  a   national   list  in  accordance  with  the provisions  of
     Regulation  (EEC) No .../... and meeting the requirements set out in
     chapter III B of the Annex and"
                                    Article 14
This  Regulation   shall   enter   into   force  twelve  months  following  its
publication in the Official Journal of the European Communities.
This Regulation shall be binding in its entirety and directly applicable in
all Member States.
Done at                                         For the Council
                                                The President
 ---pagebreak---                                           - ll-
                                         ANNEX
Chapter I.   Conditions     which     must     be     fulfilled     by    establishments
             manufacturing additives in order to obtain approval
1«   Facilities and Equipment
     Facilities   and manufacturing equipment shall be located, designed,
     constructed,    adapted    and    maintained      to   suit   the   manufacture   of
     additives.   The lay-out, design and operation of the facilities and
     equipment   must   minimize     the    risk   of   error    and   permit   effective
     cleaning   and maintenance       in   order    to   avoid   contamination, cross-
     contamination by other products and any adverse effects generally on
     the quality of the products.
     Facilities and equipment to be used for manufacturing operations which
     are   essential    for    the   quality      of   the    products    shall   undergo
     appropriate    and   regular    checks,     in    accordance    with   the   written
     procedures.
2.   Personnel
     The   manufacturer    or    his    staff    must    possess    the   knowledge   and
     experience necessary for the manufacture of additives.
3.   Production
     The    manufacturer     must    ensure     that     the    additives    conform   to
     Directive 70/524/EEC and that all manufacturing operations are carried
     out in accordance with the information given in the application.                    A
     qualified person responsible for production must be designated.
      The different stages in production shall be carried out according to
      pre-established written instructions and procedures. Measures shall be
      taken to avoid cross-contamination and errors. The critical stages in
      the manufacturing process shall be regularly checked, in accordance
      with the written procedures.
 ---pagebreak---                                    -<2 -
4.  Quality control
    The manufacturer   shall  establish  and maintain   a quality    control
    laboratory to carry out the necessary examination and analysis of raw
    materials, packaging materials and intermediate and finished products
    testing.  A qualified person responsible for quality control shall be
    designated.
    Before releasing the finished products for sale or distribution, their
    compliance with the specifications as supplied with the application
    for authorization must be checked and guaranteed.
    Samples of the active substance and of each batch of finished product
    shall be retained in order to ensure traceability.
5.  Storage
    Additives shall be stored in such a way as to to be easily identified
    and to avoid any confusion with other products. They shall be stored
    in suitable places to which only authorized persons have access.
6.  Documentation
6.1 Documentation of manufacturing process and controls
    The manufacturer must have a system of documentation        based upon
    specifications,  manufacturing   formulae,  processing  and   packaging
    instructions, procedures and the various summary sheets and records
    covering the different manufacturing operations performed.     This set
    of documents shall make it possible to trace the manufacturing history
    of each batch produced and to establish responsibility when complaints
    arise.
6.2 Commercial register
    The manufacturer must record the following information to facilitate
    traceability : the nature and quantity of the additives produced, the
    respective dates of manufacture and batch number if appropriate and
    the names and addresses of the approved manufacturers of premixtures
    or approved intermediaries to whom the additives have been delivered,
    along with an indication of the nature and quantity of additives
    delivered and batch number, if appropriate.
 ---pagebreak---                                           -13 -
7.   Commercial Intermediaries
     Where the manufacturer delivers additives to a person other than an
     approved manufacturer of premixtures, that person and any subsequent
     intermediary shall be equally bound by the obligations laid down in
     points 5 and 6.2.
8.   Complaints and product recall
     The manufacturer shall implement a system for recording and dealing
     with   complaints, together       with   an   effective    system   for  recalling
     promptly and at any time the products in the distribution network.
     Where   there   is a risk     to human      health, the     authorities   must  be
     informed.   Any   goods   returned     must   be   reassessed    and  approved  by
     quality control before being resold, where appropriate.
chapter II. Conditions     which      must    be     fulfilled     by    establishments
             manufacturing premixtures in order to obtain approval
1.   Facilities and Equipment
     Facilities    and manufacturing equipment shall be located, designed,
     constructed,    adapted    and    maintained     to   suit   the   manufacture  of
     premixtures. The lay-out, design and operation of both facilities and
     equipment   must   minimize     the   risk   of   error    and   permit  effective
     cleaning   and   maintenance     in order     to   avoid   contamination, cross-
     contamination and any adverse effects generally on the quality of the
     products.    Facilities    and   equipment     to   be  used   for   manufacturing
     operations which are essential for the quality of the products shall
     undergo appropriate and regular checks, in accordance with the written
     procedures.
     There must be a prevention scheme and regular control measures must be
     applied   to   prevent   the    entrance    of   rodents,    insects,   birds  and
     domestic animals as far as possible.
2.   Personnel
     The   manufacturer    or    his    staff   must    possess    the   knowledge  and
     experience necessary for the manufacture of premixtures.
 ---pagebreak---                                      -14 -
3.  Production
    A qualified person responsible for production must be designated. The
    different stages in production shall be carried out according to
    pre-established written instructions and procedures. Measures shall be
    taken to avoid cross-contamination and errors. The critical stages in
    the manufacturing process shall be regularly checked in accordance
    with the written procedures: incorporation, chronological order of
    production, meters and weighing apparatus, mixer, returns.
4.  Quality control
    The manufacturer    must   guarantee    and verify    the  nature, content,
    uniformity  and   stability   of   the   additives   in  the  premixture.  A
    quality control plan must be established and implemented with a view
    to achieving this goal.     A qualified person responsible for quality
    control must be designated.
    samples of the finished product shall be kept in order to ensure
    traceability.
5.  Storage
    The additives and premixtures shall be stored in such a way as to be
    identifiable and to avoid confusion with other products. They shall be
    stored  in suitable places to which only           authorized persons have
    access.
    There must be a prevention scheme and regular control measures must be
    applied  to  prevent   the   entrance    of  rodents, insects, birds     and
    domestic animals as far as possible.
6.  Documentation
6.1 Documentation of manufacturing process and controls
    The  manufacturer   must   have   a   system   of  documentation   based  on
    specifications,   manufacturing     formulae,    processing   and  packaging
    instructions, procedures and the various summary sheets and records
    covering the different manufacturing operations performed.          This set
    of documents shall make it possible to trace the manufacturing history
    of each batch produced and to establish responsibility when complaints
    arise.
 ---pagebreak---                                         -15 -
6.2  Commercial register
     The manufacturer must record the following information in order to
     ensure   traceability    : the name of      the approved manufacturers        and
     suppliers, the nature and quantity of the additives used and batch
     number if appropriate, the date of manufacture, the name and address
     of the approved compound feedingstuff manufacturers or intermediaries
     for whom the premixture is intended and the nature and quantity of the
     premixture delivered.
7.   Commercial intermediaries
     Where the manufacturer delivers premixtures to a person other than an
     approved manufacturer of compound feedingstuffs, that person and any
     subsequent intermediary shall be equally bound by the obligations laid
     down in points 5 and 6.2.
8.   Complaints and product recall
     The manufacturer shall implement a system for recording and dealing
     with   complaints, together with       an   effective   system    for  recalling
     promptly and at any time the products in the distribution network.
     Where   there  is   a risk   to  human    health, the     authorities    must be
     informed.   Any   goods  returned    must   be   reassessed    and  approved   by
     quality control before being resold, where appropriate.
chapter III.   conditions    which    must    be    fulfilled    by    establishments
               manufacturing    compound    feedingstuffs     in   order   to   obtain
               approval
III.A :    Conditions     which    must    be     fulfilled     by     establishments
          manufacturing compound feedingstuffs containing the premixtures
           referred to in chapter II, in order to obtain approval.
 ---pagebreak---                                       -16 -
1. Facilities and Equipment
   Facilities   and manufacturing equipment shall be located, designed,
   constructed,    adapted    and   maintained   to   suit   the  manufacture   of
   compound feedingstuffs containing premixtures. The lay-out, design and
   operation of the facilities and equipment must be such as to minimize
   the risk of error and permit effective cleaning and maintenance in
   order  to   avoid   contamination, cross-contamination        and  any  adverse
   effects generally on the quality of the products.
   Facilities and equipment to be used for manufacturing operations which
   are  essential    for  the quality    of   the   products   shall  undergo the
   appropriate checks in accordance with the written procedures.
   There must be a prevention scheme and regular control measures must be
   applied   to  prevent    the   entrance   of   rodents,   insects,   birds  and
   domestic animals as far as possible.
2. Personnel
   The manufacturer or his staff must possess the knowledge and have the
   appropriate experience for the manufacture of compound feedingstuffs
   containing premixtures.
3. Production
   A qualified person responsible for production must be designated. The
   different   stages   in production     shall be carried      out according   to
   pre-established written instructions and procedures. Measures shall be
   taken to avoid cross-contamination and errors. Critical stages in the
   manufacturing process shall be regularly checked in accordance with
   the   written    procedures:     incorporation,     chronological    order   of
   production, meters and weighing apparatus, mixer, returns.
 ---pagebreak---                                      -17 -
4.  Quality control
    The  manufacturer   must   guarantee   and    verify   the  nature,   content,
    uniform mix of the additives in the premixture.            A quality control
    plan must be established and implemented with a view to achieving this
    goal.   A qualified   person responsible      for quality    control must be
    designated.
    The various analytical components must be checked for conformity with
    Directive 79/373/EEC    by   means    of    a   quality   control   plan   and
    appropriate methods.
    Samples of the finished product shall be kept in order to ensure
    traceability.
5.  Storage
    The premixtures and/or additives shall be stored in such a way as to
    be identifiable and to avoid confusion with other products. They shall
    be stored in suitable places to which only authorized persons have
    access.
    There must be a prevention scheme and regular control measures must be
    applied   to prevent   the   entrance    of   rodents,   insects,  birds   and
    domestic animals as far as possible.
6.  Documentation
6.1 Documentation of the manufacturing process and controls
    The  manufacturer   shall   have   a  system    of   documentation   based  on
    specifications,   manufacturing     formulae,     processing   and  packaging
    instructions, procedures and the various summary sheets and records
    covering the different manufacturing operations performed.            This set
    of documents shall make it possible to trace the manufacturing history
    of each batch processed and establish responsibility when complaints
    arise.
 ---pagebreak---                                          -18 -
6.2   Commercial register
      The manufacturer must record the following information in order to
      ensure traceability : the name of the approved premixture supplier and
      approved manufacturer if he is not the supplier, the batch number if
      appropriate, the nature and quantity of the premixture and the use to
      which it will be put.
7.    Complaints and product recall
      The manufacturer shall implement a system for recording and dealing
     with   complaints, together with        an   effective    system   for  recalling
      promptly and at any time the products in the distribution network.
     Where   there   is a risk     to human     health, the     authorities    must  be
      informed.   Any   goods  returned    must   be   reassessed   and   approved   by
     quality control before being resold, where appropriate.
Ill B.     Conditions     which     must    be     fulfilled     by    establishments
           manufacturing      compound     feedingstuffs      from    raw    materials
           containing high levels of undesirable substances and products
1.   Facilities and Equipment
     Facilities    and manufacturing equipment shall be located, designed,
     constructed,     adapted   and   maintained    to   suit   the   manufacture    of
     compound feedingstuffs from raw materials containing high levels of
     undesirable substances and products. The lay-out, design and operation
     of the facilities and equipment must be such as to minimize the risk
     of errors and permit effective cleaning and maintenance in order to
     avoid   contamination,     cross-contamination      and   any  adverse    effects
     generally    on the quality of the products.
     Facilities and equipment to be used for manufacturing operations which
     are  essential    for the quality      of   the   products   shall   undergo the
     appropriate checks in accordance with the written procedures.
     There must be a prevention scheme and regular control measures must be
     applied   to   prevent   the   entrance   of    rodents,   insects,    birds   and
     domestic animals as far as possible.
 ---pagebreak---                                    -19 -
2. Personnel
   The manufacturer or his staff must possess the knowledge and have the
   necessary  experience   for the manufacture of compound      feedingstuffs
   from raw materials containing high levels of undesirable substances
   and products.
3. Production
   A qualified person responsible for production must be designated. The
   different  stages   in production   shall be carried   out   according  to
   pre-established written instructions and procedures. Measures shall be
   taken to avoid cross-contamination and errors.    The critical stages in
   the manufacturing process shall be regularly checked in accordance
   with the written procedures: incorporation, chronological order of
   production, meters and weighing apparatus, mixer, returns.
4. Quality control
   The manufacturer must guarantee and verify the nature, content, and
   uniform mix of the undesirable products and substances in the compound
   feedingstuff.   A   quality  control   plan  must   be   established   and
   implemented to achieve this goal and to comply with the maximum limits
   permitted in compound feedingstuffs.     A qualified person responsible
   for quality control must be designated.
   The various analytical components must be checked for conformity with
   Directive 79/373/EEC    by  means   of   a  quality   control   plan   and
   appropriate methods.
   Samples of the finished product shall be kept in order to ensure
   traceability.
5. Storage
   The raw materials and the compound feedingstuffs shall be stored in
   such a way as to be identifiable and to avoid confusion with other
   products.  They   shall be  stored   in suitable  places   to which   only
   authorized persons have access.
 ---pagebreak---                                    - JLO -
    There must be a prevention scheme and regular control measures must be
    applied  to  prevent   the  entrance    of   rodents,    insects,  birds   and
    domestic animals as far as possible.
6.  Documentation
6.1 Documentation of the manufacturing process and controls
    The  manufacturer   shall  have  a   system    of   documentation   based   on
    specifications,   manufacturing    formulae,     processing   and   packaging
    instructions, procedures and the various summary sheets and records
    covering the different manufacturing operations performed.           This set
    of documents shall make it possible to trace the manufacturing history
    of each batch produced and establish responsibility when complaints
    arise.
6.2 Commercial register
    The manufacturer must record the following information in order to
    ensure  traceability   : the name    of   the   supplier   of  raw materials
    containing high levels of undesirable substances and products and the
    name of the manufacturer if he is not the supplier, the nature and
    quantity of undesirable substances and products and the use to which
    they will be put.
7.  Complaints and product recall
    The manufacturer shall implement a system for recording and dealing
    with  complaints, together    with   an   effective    system  for  recalling
    promptly and at any time the products in the distribution network,
    where  there  is   a risk  to  human    health, the     authorities   must  be
    informed.  Any   goods  returned  must    be  reassessed    and  approved   by
    quality control before being resold, where appropriate.
 ---pagebreak---                                         - XI -
III C.    Conditions     which     must     be      fulfilled      by     establishments
          manufacturing compound feedingstuffs in order to obtain approval
1.   Facilities and Equipment
     Facilities   and manufacturing equipment shall be located, designed,
     constructed,    adapted   and    maintained      to   suit  the    manufacture    of
     compound   feedingstuffs.    The    lay-out, design       and   operation    of  the
     facilities and equipment must be such as to minimize the risk of error
     and  permit   effective    cleaning    and maintenance       in    order  to   avoid
     contamination, cross-contamination and any adverse effects generally
     on the quality of the products.
     Facilities and equipment to be used for manufacturing operations which
     are  essential   for   the quality     of    the   products    shall   undergo the
     appropriate checks.
     There must be a prevention scheme and regular control measures must be
     applied  to   prevent    the   entrance     of   rodents,    insects,    birds   and
     domestic animals as far as possible.
2.   Personnel
     The manufacturer or his staff must possess the knowledge and have the
     appropriate experience for the manufacture of compound feedingstuffs.
3.   Production
     A qualified person responsible for production must be designated. The
     different   stages   in production      shall be carried         out  according   to
     pre-established    written    instructions      and   procedures.     The  critical
     stages in the manufacturing process must be checked: incorporation,
     meters and weighing apparatus, mixer.
4.   Quality control
     The manufacturer must have the means to guarantee                   and verify   the
     uniform mix of     the   ingredients     in the compound        feedingstuff. The
     various   analytical components must be checked             for conformity      with
     Directive 79/373/EEC      by    means    of    a    quality    control    plan   and
     appropriate    methods.    A   qualified     person    responsible     for   quality
     control must be designated.
 ---pagebreak---                               - 22 -
storage
The raw materials and the compound feedingstuffs shall be stored in
such a way as to be identifiable and to avoid confusion with other
products. They shall be stored in suitable places.
There must be a prevention scheme and regular control measures must be
applied  to  prevent  the  entrance  of rodents,   insects, birds  and
domestic animals as far as possible.
 ---pagebreak---                                              2-S
                                                                     KSN 0254-1475
                                                              COM(93) 587 final
                                                      DOCUMENTS
EN                                                                             03
                                 Catalogue number : CB-CO-93-624-EN-C
                                                             ISBN 92-77-61647-4
Office for Officiai Publications of the European Communities
L-2985 Luxembourg