CELEX: 51989PC0509
Language: en
Date: 1989-10-17
Title: PROPOSAL FOR A COUNCIL REGULATION ( EEC ) LAYING DOWN THE VETERINARY RULES FOR THE DISPOSAL AND PROCESSING OF ANIMAL WASTE, FOR ITS PLACING ON THE MARKET AND FOR THE PREVENTION OF PATHOGENS IN FEEDSTUFFS

COMMISSION OF THE EUROPEAN COMMUNITIES
                                               COM(89) 509 f i n a l
                                               Brussels, 17 October 1989
                             Proposal for a
                       COUNCIL REGULATION (EEC)
  laying down the veterinary rules for the disposal and processing
     of animal waste, for i t s placing on the market and for the
                prevention of pathogens in feedstuffs
                     (presented by the Commission)
 ---pagebreak---                                  EXPLANATORY MEMORANDUM
   The Community must adopt the measures aimed at establishing the internal
   market during a period expiring on 31 December 1992.   The need for free
   movement of animals and animal products must be reconciled with the need to
   protect public and animal health.
   The present proposal intends to harmonize the rules for disposal of cadavers,
   slaughter offals and other animal waste in order to prevent the spread of
   pathogens into the environment and the animal production chain.    Depending on
   the type of material and the risks involved, appropriate measures should be
   taken to ensure that animal waste is destroyed or processed into harmless
   products.   For animal waste which is considered as high-risk, the Commission
   is proposing that the Member States set up a system of collection by
   designating, for each part of their territory one or more sterilization plants
   responsible for collecting high-risk material, in the defined part of the
   territory and sterilizing it.
   Such a system is at present functioning in most of the Member States and is in
   general considered as the most favourable and safest way of disposal.
   Nevertheless in some circumstances burning or burial should remain possible
   where this manner of disposal is preferred for practical reasons or when
    transport of cadavers of animals infected with epizootic diseases is too
    dangerous.
    The present proposal allows, under certain conditions, the profitable use of
    animal waste in other ways, for instance by using it for the preparation of
    petfood or technical products.   However, it should be ensured that such
    alternative ways of disposal are without special risks. Free movement in the
    Community of animal waste with a low-risk, when identified in an appropriate
   manner, should be possible, in order to process it in registered plants having
    adequate facilities to treat it in a safe way.
    Apart from some derogations for animal waste with a high risk, which have
    already been laid down in the proposal, it should be possible, in particular
    in order to take into account new technological developments, to lay down
    other derogations.  It is proposed that the Commission is entrusted to lay
    down these derogations and their applicatory rules.
21
 ---pagebreak---                                       - 2 -
The present Community hygiene rules concerning intra-Community trade in meat
and trade in poultry meat, do not apply to slaughter by-products which are
with the permission of the Member State of destination used for purposes other
than human consumption.   As it is proposed that these slaughter by-products
shall be processed in an approved sterilization plant or in a registered plant
preparing petfood, pharmaceutical or technical products, and must be clearly
identified, the present national rules should be repealed.
To be successful in reducing the spread of pathogens in the animal production
chain attention should be paid to the role of feedstuffs.    Feedstuffs consist
mostly, apart from animal protein and animal fat, of other components which
might be contaminated with pathogens.   It is, in the first place, the
responsibility of the manufacturer of feedstuffs to ensure the microbiological
safety of his products. Therefore it is proposed that the manufacturer should
take all preventive measures necessary, if necessary by subjecting feedstuffs
to a treatment to eliminate pathogens, and should carry out microbiological
checks at all stages of production.   To give support to industries and
 competent authorities it is also proposed that the Commission should develop
 guidelines with recommended rules for the hygienic production of feedstuffs.
 The Commission is proposing for the applicatory decisions the Regulatory
 Committee formula.  This choice is justified in this case by a desire not to
 disrupt the management process in the veterinary field.   It is without
 prejudice to the Commission's reference for the Consultative Management
 formula.
 This proposal appears in the timetable in the Annex to the White Paper on
 completing the internal market.
 ---pagebreak---                                  Proposal for a
                           COUNCIL REGULATION (EEC)
        laying down the veterinary rules for the disposal and processing
                 of animal waste, for its placing on the market
                and for the prevention of pathogens in feedstuffs
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 of the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas the Community is to adopt measures designed to establish the inter-
nal market progressively over a period expiring on 31 December 1992;
Whereas livestock production occupies a very important position in agriculture
in the Community; whereas, in addition, animal waste, when not disposed of
correctly, may spread pathogens in the environment leading to decreased
productivity and margins in this sector;
Whereas the presence of pathogens in products of animal origin should be pre-
vented in order to ensure safe and healthy products for the consumer;
Whereas the free movement of products obtained by sterilization of animal
waste should be encouraged;
 (1) OJ No
 (2) OJ No
 (3) OJ No
 ---pagebreak---                                        - 2 -
Whereas provisions relating to* the production and placing on the market of
fresh meat and poultry meat have been laid down in Council Regulation (fresh
meat)      and Council Regulation (poultry meat) *    whereas these provisions
do not apply to slaughter by-products which are not intended for human
consumption; whereas it is opportune to lay down harmonized rules for the
trade and disposal of slaughter by-products;
Whereas in the context of the Community policy of harmonizing national animal
health and public health provisions governing trade in animals and animal
products, it is now necessary to create a harmonized system to ensure that
animal waste is disposed of in such a way that the risk of spreading pathogens
 is virtually eliminated;
Whereas animal waste should be processed in an approved and supervised
processing plant or disposed of in another suitable manner; whereas, in
addition,   animal  waste  associated  with  a  high  risk  should  be
 collected and transported directly to a processing plan designated by the
 Member State concerned; whereas in certain circumstances, especially when this
 is justified by distance and time of transport, the designated processing plant
 could be located in another Member State;
 Whereas profitable alternative uses for animal waste should be encouraged;
 whereas this should be possible when it is ensured that such alternative use
 is without risk to the health of livestock or humans;
 Whereas in order to prevent the introduction of pathogens in livestock,
 measures are also necessary to ensure the production of hygienically safe
 feedstuffs; whereas, for this purpose, the manufacturers of feedstuffs should
 monitor their production; whereas, in addition, guidelines for the hygienic
 production of feedstuffs should be developed;
 ---pagebreak---                                         - 3
Whereas the Commission should be entrusted with taking measures for implement-
ing this Regulation; whereas to that end procedures should be established for
co-operation between the Commission and the Member States,
HAS ADOPTED THIS REGULATION :
                                      CHAPTER I
                                 GENERAL PROVISIONS
                                      Article 1
1. This Regulation lays down animal and public health requirements for the
    disposal and processing of animal waste in order to destroy pathogens which
    might be present in this material, and for the production of feedstuffs in
    such a manner as to prevent the presence of pathogens therein.    This
    Regulation includes rules for the placing on the market of slaughter
    by-products, intended for purposes other than human consumption.
 2. This Regulation shall not affect the veterinary legislation concerning the
    eradication of specific diseases.
                                      Article 2
 For the purpose of this Regulation the following definitions shall apply :
 "animal waste" : low-risk and high-risk materials of animal or marine origin,
 including dead animals, which need to be disposed of or processed in such a
 way as to prevent the spread of animal diseases or zoonoses.    For the purposes
 of this Regulation animal excreta and table scraps are not regarded as animal
 waste;
 "low-risk materials" : slaughter by-products of animal or marine origin
 without special hazards for spreading animal diseases or zoonoses;
 "hifth-risk materials*'.: materials of animal or marine origin designated in
 this Regulation suspected or demonstrated to be a serious risk for spreading
  animal diseases or zoonoses;
 ---pagebreak---                                        - 4 -
"slaughter by-products** : by-products of slaughter, not intended for human
consumption, and exclusively derived from animals from which the meat has been
approved for human consumption;
"processing plant** : a plant in which animal waste is sterilized in order to
destroy pathogens;
"petfood" : food for dogs, cats and other pet animals, prepared or partly
prepared from meat or offals;
"technical products" : products intended for purposes other than human or
animal consumption;
"feedstuffs" : feedstuffs as defined in Article 2(a) of Council Directive
79/373/EEC (1);
"establishment" : processing plant, petfood plant or plants where slaughter
by-products are used for the preparation of technical products;
"competent authority" : the authority designated by the Member State concerned,
                                    CHAPTER II
                  RULES CONCERNING THE TREATMENT OF ANIMAL WASTE
                  AND PLACING ON THE MARKET OF THE FINAL PRODUCT
                              A. HIGH-RISK MATERIALS
                                     Article 3
1. The following high risk materials shall be processed in a nearby processing
    plant, designated by the Member State in accordance with Article 4(1), or
    disposed of by burning or burial in accordance with paragraph 2 :
    a) bovine animals, domestic pigs, goats, sheep, solipeds, poultry and other
       animals kept for agricultural production, which died on the farm,
       including stillborn and unborn animals;
 (1) OJ No L 86, 06.04.1979, p. 30.
 ---pagebreak---                                        - 5 -
   b) dead   animals  not  referred  to  in  (a)  but  which  are  designated   by
       the competent authority of the Member State;
   c) animals which are killed either on the farm, or after arrival at the
       processing plant, in order to eradicate epizootic diseases;
   d) animal waste originating from animals which show, during veterinary
       inspection at slaughter, clinical signs or evidence of diseases communi-
       cable to humans and which are for that reason, or due to the presence of
       residues, excluded from human consumption;
   e) those parts of slaughtered animals not presented for post-mortem
       inspection, with the exception of hides, skins, hooves, feathers, wool,
       horns and similar products;
   f) meat, poultry meat, fish, fish products, game and meat products, which
       are spoiled;
   g) animals, fresh meat, poultry meat, fish, game and meat products imported
       from third countries, not complying with the veterinary requirements for
       their importation into the Community, unless they are re-exported or
       their import   is   accepted  under restrictions laid down in Community
       provisions.
2. The competent authorities may decide that high-risk material must be
   disposed by burning or by burial, when :
   - the transport of animals infected or suspected to be infected with an
      epizootic disease to the nearest rendering plant is rejected because of
      the danger of animal health involved;
   - a wide-spread epizootic disease leads to a lack of capacity at the pro-
      cessing plant;
   - the animal waste concerned originates from places with difficult access;
   - the animals are infected with or suspected to be infected with a serious
      disease, which may constitute a threat to human or animal health, and
      which could survive heat-treatment;
   - the quantity and the distance to be covered does not justify its
      collection.
    Burial shall be deep enough to prevent carnivorous animals from digging up
    the cadavers and shall be in dry ground.   Before burial the cadavers shall
    be covered with creoline or other substance prescribed by the competent
    authority.
 ---pagebreak---                                         - 6 -
                                      Article 4
1. Member States shall designate for each part of their territory one or
   more processing plants for the collection and processing of high risk
   material.    A Member State may decide to designate a processing plant in
    another Member State after agreement with that other Member State.
2. Processing plants shall :
    (i)    be approved by the competent authority and meet the requirements of
           Annex II, Chapter I;
    (ii)   handle, process and store animal waste in accordance with Annex II,
           Chapter II;
    (iii) be checked by the competent authority in accordance with Article 10;
    (iv)   ensure that the products of processing satisfy the requirements of
           Annex II, Chapter III.
                                B. LOW-RISK MATERIALS
                                      Article 5
 1. Low-risk materials shall be processed in an approved processing plant, in a
    petfood plant, in a plant preparing pharmaceutical or technical products or
    must be disposed of by burning or burial in accordance with Article 3(2).
 2. Processing plants processing low-risk materials shall meet the requirements
     laid down in Article 4, paragraph 2. When low-risk materials are processed
     together with high-risk materials, the mixture is considered as high-risk
    materials.
 3. Establishments, using low-risk materials for the preparation of petfood,
     pharmaceutical or technical products shall :
     (i) be registered by the competent authority and satisfy the conditions of
          Annex III;
     (ii) be inspected by the competent authority at regular intervals to check
          compliance with this Regulation.
 ---pagebreak---                                       - 7 -
                                    Article 6
The treatment which certain slaughter by-products must undergo during the
preparation of petfood may be established in accordance with the procedure
laid down in Article 21 insofar as this is necessary for the protection of pet
animals or for public or animal health reasons.
                                 C. DEROGATIONS
                                    Article 7
1. The competent authorities may exceptionally authorize thé use of :
   (i)  animal waste for scientific purposes;
   (ii) animal waste, referred to in Article 3, paragraph 1(a), (b) and (e)
        and in Article 5, for the feeding of zoo, circus and fur animals, and
        in special cases for other animals.
2. In accordance with the procedure laid down in Article 21 other exceptions
   and the conditions to be respected for their application may be established.
                              D. GENERAL PROVISIONS
                                    Article 8
Animal waste shall be collected, transported and identified in accordance with
the hygiene requirements laid down in Annex I.
                                    Article 9
Operators of processing plants shall adopt all measures necessary to comply
with the requirements of this Regulation and shall, in particular :
 ---pagebreak---                                       - 8 -
- identify and control the critical points in the processing plant;
- take samples in order to check the microbiological condition of the products
  after heat-treatment;
- record and keep the results of the various checks and tests for presentation
  to the competent authorities for a period of at least two years;
- give each dispatched batch a lot number in such a way that it is possible to
  trace back the period of its production.  This lot number must appear on the
  document accompanying the lot or on the label.
                                   Article 10
1. The competent authorities shall carry out, at regular intervals, inspect-
   ions and random checks at the approved processing plants on :
   - their compliance with the provisions of this Regulation;
   - the microbiological condition of the products after heat treatment.
2. The analyses and tests shall be carried out in accordance with proven and
   scientifically recognized methods, in particular those laid down in
   Community provisions or other international standards.
                                   Article 11
1. Each Member State shall draw up a list of approved processing plants and
   shall give each plant an official number. The Member States shall forward
   this list to the other Member States and the Commission.
2. If inspections reveal that not all requirements of this Regulation are
   being met the competent authority shall take appropriate action.
 ---pagebreak---                                        - 9 -
                                    Article 12
1. Veterinary experts from the Commission may, in so far as it is necessary to
    ensure uniform application of this Regulation, make on-the-spot checks;
    they may in particular verify whether approved establishments are actually
    complying with this Regulation.  The Commission shall inform the Member
    States of the results of the investigations.
    A Member State in whose territory a check is being carried out shall give
    all the necessary assistance to the experts carrying out their duties.
    The general provisions for implementing this Article shall be determined in
    accordance with the procedure laid down in Article 21.
2. The Member State concerned shall take all measures necessary to take
    account of the results of the checks referred to in paragraph 1. If the
    Member State fails to take those measures, the Commission may, in accor-
    dance with the procedure laid down in Article 20, prohibit the placing on
    the market of products coming from a processing plant which no longer
    complies with the provisions of this Regulation.
                                    Article 13
The rules laid down in Council Regulation No              (1), concerning vete-
rinary checks in intra-Community trade, with a view to the realisation of the
 internal market, will apply, in particular with respect to the organisation of
and the action to be taken following the controls carried out by the Member
State of destination, and the safeguard measures to be applied.
(1) C0M(88) 383 final
 ---pagebreak---                                        - 10 -
                                    CHAPTER III
              RULES RELATING TO MICROBIOLOGICAL CONTROL OF FEEDSTUFFS
                                    Article 14
Manufacturers of feedstuffs shall adopt all measures necessary to avoid the
contamination of feedstuffs with pathogens.    In particular they must :
- establish, if necessary, the appropriate treatment by heat and pressure or
   other method to decontaminate feed components of animal, marine or vegetable
   origin;
- identify and control the critical points in processing;
- take measures to avoid recontamination;
- carry out microbiological controls in accordance with Article 15.
                                     Article 15
1. Manufacturers of feedstuffs shall at regular intervals carry out microbio-
    logical controls.
2. The microbiological controls shall include :
    - examination for salmonella or enterobacteriaceae in different feed compo-
      nents of animal, marine or vegetable origin;
    - examination for salmonella or enterobacteriaceae in feedstuffs;
    - if necessary, examination of possible sources of contamination, such as
      floor sweepings, dust, containers and vehicles.
 3. When the microbiological controls reveal that feedstuffs are contaminated
    with pathogens the manufacturer shall take appropriate action, in parti-
    cular the manufacturer shall :
    - (re-)process contaminated lots;
    - intensify the controls.
 ---pagebreak---                                       - 11 -
                                    Article 16
The Commission may establish a recommendation with guidelines for the hygienic
manufacturing of feedstuffs.   This recommendation may include criteria for
sampling and microbiological criteria.
                                    CHAPTER IV
                                 FINAL PROVISIONS
                                    Article 17
1. The Commission, acting in accordance with the procedure laid down in
    Article 21, shall establish the detailed arrangements for the checks
    provided for in Article 10(1).
2. The Commission, acting in accordance with the same procedure, shall
    establish the reference methods for bacteriological examinations.
                                    Article 18
 The Annexes to this Regulation shall be amended by the Commission, in
 accordance with the procedure laid down in Article 21, in order in particular
 to bring it into line with technological progress.
                                    Article 19
 Until the implementation of Community rules concerning the importation of
 animal waste, their products and feedstuffs from third countries, Member
 States shall apply to those importations conditions at least equivalent to
 those laid down in this Regulation.   However, import of high-risk
 materials referred to in Article 3(1)(a) to (l)(f) shall be prohibited.
 ---pagebreak---                                       - 12 -
                                    Article 20
1. Where the procedure laid down in this Article is to be followed, matters
   shall be referred without delay by its Chairman, either on his own
   initiative or at the request of a Member State, to the Standing Veterinary
   Committee (hereinafter called "the Committee") set up by Council Decision
   68/361/EEC (1).
2. 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.   The opinion shall be delivered by the 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.
3. The Commission shall adopt the measures envisaged if they are in accordance
   with the opinion of the Committee.
4. 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 of fifteen days from the date of referral to
    the Council, the Council has not acted, the proposed measures shall be
    adopted by the Commission.
 (1) 0J No L 255, 18.10.1968, p. 23.
 ---pagebreak---                                       - 13 -
                                    Article 21
1. Where the procedure laid down in this Article is to be followed, the
   following provisions shall apply.
2. 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 the time limit which the Chairman lays down according to
   the urgency of the matter.   The opinion shall be delivered by the 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.
3. The Commission shall adopt the measures envisaged if they are in accordance
   with the opinion of the Committee.
4. 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 of three months from the date of referral to
   the Council, the Council has not acted, the proposed measures shall be
    adopted by the Commission.
                                    Article 22
This Regulation shall enter into force on 1 January 1991.
This Regulation shall be binding in its entirety and directly applicable in
all Member States.
Done at Brussels,                                           For the Council
 ---pagebreak---                                       ANNEX I
            HYGIENE REQUIREMENTS FOR THE COLLECTION AND TRANSPORTATION
                                  OF ANIMAL WASTE
1. Animal waste shall be collected and transported to the establishments in
   suitable containers or vehicles in such a way as to prevent leakage. The
   containers and vehicles must be adequately covered.
2. Vehicles and reusable containers shall be maintained in a clean condition.
3. The competent authority shall take the necessary measures to control the
   movement of high-risk materials, if necessary by requiring the keeping of
   records or of documents which shall accompany these materials during their
   transportation to the place of disposal, or by sealing.
4. During transportation low-risk materials shall be accompanied by a document
   indicating :
   a) the origin;
   b) name or nature of the animal waste;
   c) the quantity.
   When not transported directly in bulk from the slaughterhouse to a process-
    ing plant the information referred to in point a), b ) , c) and the words
   "Inedible, not for human consumption" shall also be indicated on a label
   attached to the container, cartons or other packaging material in letters
   of at least 2 cm high.
 ---pagebreak---                                       ANNEX II
                     HYGIENE REQUIREMENTS FOR PROCESSING PLANTS
Chapter I : Approval requirements for processing plants
1. Buildings and facilities shall meet the following requirements :
   a) the premises of the processing plant shall be adequately separated from
      the public highway and other premises such as slaughterhouses.     Premises
       for the processing of high-risk material shall not be at the same site
       as slaughterhouses, unless in a completely separated building;
       unauthorised persons and animals shall have no access to the plant;
   b) the plant shall have a clean and an unclean section, adequately
       separated.   The unclean section shall have a covered place to receive
       the animal waste and shall be constructed in such a way that it is easy
       to clean and disinfect.   Floors must be laid in such a way as to
       facilitate the draining of liquids.    It shall have adequate lavatories,
       changing rooms and washbasins for staff.
       In the unclean section, where appropriate, there shall be adequate faci-
       lities for deskinning or dehairing of animals and a storage room for
       hides;
    c) a sufficient capacity and steam production is required for the process-
        ing of animal waste in accordance with Chapter II.
    d) the unclean section shall, if appropriate, contain equipment to reduce
        the size of animal waste and equipment for loading the crushed animal
       waste into the processing unit;
    e) a closed processing installation is required in which the animal waste
       must be processed in accordance with Chapter II. This installation must
        be fitted with :      »•
        - measuring equipment to check temperature and pressure at critical
          points;
        - recording devices to record continuously the results of measurements;
        - an adequate safety system to prevent insufficient heating;
 ---pagebreak---                                        - 2 -
   f) to exclude recontamination the installations and facilities for the
       unloading of the processing installation, further processing of the
       heated material and the storage of the final products shall be
       adequately separated from the unclean section.
2. The processing plant shall have adequate facilities to clean and disinfect
   the containers in which animal waste is received and vehicles in which it
    is tranported.
3. Adequate facilities shall be provided to disinfect wheels of vehicles
    transporting high-risk material immediately before they leave the site.
4. A waste water disposal system which meets hygienic requirements is required,
5. The processing plant shall have its own laboratory or make use of the ser-
    vices of a laboratory equipped to make the essential analyses and in parti-
    cular to check conformity with Chapter III.
Chapter II : Hygiene requirements relating to operations
1. Animal waste shall be processed as soon as possible after arrival. It
    shall be stored properly until processed.
2. Containers and vehicles used for the transport of animal waste must be
    cleaned, washed and disinfected after each use.
3. Persons working in the unclean section shall not enter to the clean section
    without changing their working clothes and foot-gear.   Equipment and
    utensils shall not be taken from the unclean section into the clean section.
4. Waste water originating in the "unclean" area in a processing plant dealing
    with high-risk materials shall be decontaminated in a sterilisation unit or
    by chemical means.
 5. Preventive measures against rodents, insects or other vermin shall be sys-
    tematically taken.
 ---pagebreak---                                        - 3 -
6. Animal waste shall be processed under the following conditions :
   a) before heating, if appropriate, the materials must be crushed to reduce
       the size of particles;
   b) animal waste must be processed in such a way that after processing the
       products satisfy the microbiological standards laid down in Chapter III.
       In accordance with the procedure laid down in Article 21 the F -value
                                                                     o
       which must be achieved in the centre of the largest particle shall be
       laid down.  The most important parameters of the procedure shall be
       recorded continuously by reliable methods, providing evidence of
       sufficient heating.
7. Installations and equipment shall be kept in a good state of repair and
   measuring equipment must be calibrated at regular intervals.
8. The finished products shall be stored at the processing plant in such a way
   as to exclude recontamination.
9. Hides shall be salted over a period of at least 8 days using salt with 5 %
    soda added.
Chapter III : Requirements concerning the products after processing
1. In the case of high-risk materials, samples of the product, directly taken
    after completion of the sterilization process, must be free from
    heat-resistent spores of bacteria (Clostridium perfringens absent in 1 g).
2. Samples of the final products from both low-risk and high-risk material
    taken during storage at the processing plant shall comply with the follow-
    ing standard :
 ---pagebreak---                                    - 4 -
Salmonella in 25 g : n = 5, c = 0, m = 0, M = 0
                                                   2
enterobacteriaceae : n = 5, c = 2, m = 10, M = 3x10 in 1 g.
where :
n « number of sample units comprising the sample;
m » threshold value for the number of bacteria; the result is considered
    satisfactory if the number of bacteria in all sample units does not
    exceed m;
M » maximum value for the number of bacteria; the result is considered
    unsatisfactory if the number of bacteria in one or more sample units is
    M or more;
c * number of sample units the bacterial count of which may be between m
    and M, the sample still being considered acceptable if the bacterial
    count of the other sample units is m or less.
 ---pagebreak---                                     ANNEX III
         REGISTRATION REQUIREMENTS FOR ESTABLISHMENTS PREPARING PETFOOD.
                      PHARMACEUTICAL OR TECHNICAL PRODUCTS
Establishments using,animal waste for the preparation of petfood,
pharmaceutical or technical products shall satisfy the following conditions to
be registered by the competent authorities :
a) they shall have adequate provisions to store and to treat the animal waste
   in a safe way;
b) they shall have adequate arrangements to destroy unused animal waste
   remaining after the production of petfood, technical products or
   pharmaceuticals, or they must sent it to a processing plant or to an
   incinerator.
 ---pagebreak---                                                                                (PVET/EN/0020)
                F I N A N C I A L                    S T A T E M E N T
     Concerning;
     Draft proposal for a Council Regulation laying down the veterinary rules for the
     disposal and processing of anisal waste, its placing on the larket and for the
     prevention of pathogens in feedstuffs.
1.   Budget heading             Item               Title
          III B                  382               Inspection In Agriculture
2.   Legal basis
     Article 43 of the Treaty.
3.   Classification ; Non-coipuIsory expenditure
4.   Purpose / description of the seasure
     Verification of the application of the Regulation (Art. 12)
5.   Method of calculation
5.1. Fors of expenditure : Mission expenses
5.2. Conunlty contribution : 100 X
5.3. Calculation
      200 lisslon days per year at ECU 170 per day (current cost of inspections)
      ECU 34,000 per year.
6.    Financial Implication as regards operating appropriations
6.1. Schedule of appropriations (ECU •llllon)
         Year                   C.A./P.A.
         1991                      0.034
         1992                      0.034
         1993                      0.034
         1994                      0.034
         1995                      0.034
         Following years
         Total                    0.170
6.2. Financing during current year : NIL
 7.   Observations :
      This proposal also calls for 1 additional A7/6 post.
      The Budget Couittee will decide under which Ites this expenditure will be charged
      when the 1990 draft budget Is drawn up.
 ---pagebreak---                           IMPACT SUR L'ACTIVITE ECONOMIQUE
Désignation de la      Projet de proposition de Règlement du Conseil arrêtant les
proposition            règles sanitaires relatives à l'élimination et à la
                       transformation des déchets animaux, à leur mise sur le
                       marché et à la protection des aliments des animaux contre
                        les agents pathogènes.
Objectifs               Cette proposition vise à harmoniser les règles concernant
                        l'élimination des déchets animaux, les échanges de
                        sous-produits d'abattage destinés à d'autres usages que la
                        consommation humaine et à la lutte contre les agents
                        pathogènes des aliments des animaux en vue de protéger la
                        santé des personnes et des animaux et de modifier les
                        conditions d'importation actuellement en vigueur dans les
                        Etats membres.
Effets sur l'activité : Cette proposition définit tout d'abord les exigences
 économique             sanitaires relatives à l'élimination des déchets animaux
                        et aux échanges de sous-produits d'abattage.
                        Cette partie de la proposition a été conçue de telle
                        manière que son effet sur les entreprises commerciales
                        puisse être considéré comme faible étant donné que la
                         proposition inclut, à tout prendre, les systèmes
                         actuellement en vigueur dans les divers Etats membres en
                         les. déclarant équivalents.
                         La seconde partie de la proposition institue des mesures
                         de contrôle microbiologiques des aliments des animaux sur
                         le lieu de production.   Les dépenses relatives à ces
                         mesures seront limitées et largement compensées étant
                         donné qu'elles remplacent les coûts engagés par l'acheteur
                         en vue de vérifier la qualité de l'aliment et sa
                         conformité avec les exigences sanitaires à l'importation.
                         L'impact global sur l'activité économique devrait être
                         faible.
 ---pagebreak---  ---pagebreak---  ---pagebreak---                                                                      ISSN 0254-1475
                                                              COM(89) 509 final
                                                      DOCUMENTS
EN                                                                              03
                                Catalogue number : CB-CO-89-500-EN-C
                                                             ISBN 92-77-54349-3
Office for Official Publications of the European Communities
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