CELEX: 51998PC0749
Language: en
Date: 1998-12-11
Title: Proposal for a Council Decision regulating the use of material presenting risks as regards transmissible spongiform encephalopathies and amending Commission Decisions 94/474/EC and 97/534/EC

COMMISSION OF THE EUROPEAN COMMUNITIES
                                              Brussels, 11.12.1998
                                              COM(1998) 749 final
                                      Proposal for a
                                COUNCIL DECISION
   regulating the use of material presenting risks as regards transmissible spongiform
   encephalopathies and amending Commission Decisions 94/474/EC and 97/534/EC
                             (presented by the Commission)
Hi
 ---pagebreak---  ---pagebreak---                              EXPLANATORY MEMORANDUM
1. The proposed decision replaces and postpones Commission Decision 97/534/EC laying
   down the rules on the prohibition of the use of material presenting risks as regards
   transmissible spongiform encephalopathies (SRM). It respects the invitation to the
   Commission, of the Council of March 1998, to base an appropriate proposal in the field
   of SRMs on the OIE Code on BSE.
   It amends the provisions of 97/534/EC in respect of the following points:
        Cosmetic, medicinal and industrial products and medical devices are excluded from
        the scope.
        The Decision allows Member States and exporting third countries to remove SRMs
         in the light of their geographical risk. The following procedure applies:
        Member States may submit the data necessary to allow assessment of their
         geographical BSE risk by 30 June 1999 at the latest. Countries which have not
         submitted a dossier by this date will be placed in a category by the Commission on
        the basis of all available information. The data of countries that have submitted a
         dossier, will be assessed by the Scientific Steering Committee. On the basis of their
         recommendation, the Commission will take a decision after consultation of the
         Member States (regulatory committee procedure). Third countries will also be
         invited to submit the necessary data in the same time scale.
         The list of SRM is based on the relevant international standard, the OIE Code on
         BSE, and its currently proposed revision. This implies an enlargement in
         accordance with the opinion of the Scientific Steering Committee (SSC) of
         9 December 1997 in areas which are placed in Category 4, i.e. those with the
         highest BSE risk. On the basis of the lower infectivity levels of certain tissues, as
         listed in the opinion of the SSC of 27 March 1998, a choice was made not to require
         the removal in areas with a lower BSE risk of the tissues with the lowest infectivity
         level and which were not recommended to be removed by the international standard
         for those areas. This list will apply as from 1 October 1999, allowing for time for
         the assessment of the dossiers by the scientific committees and taking into account
         their recommendations, as well as the development of the international standard
         after May 1999 and new scientific advice.
         An exemption for Member States applying a compulsory single carcass test for
         bovines above a certain age is introduced in the Decision. As a precondition, such
         tests must be approved by the Commission. A derogation for products derived from
         tested carcasses to be imported from third countries is also foreseen.
2.  This proposed decision follows the advice given by the SSC on 9 December 1997 and
    on 27 March 1998 and improves consumer safety while avoiding unjustified trade,
    economic and technical conséquences. In addition, it allows future scientific advice to
    be taken into account and for respects WTO notification requirements.
 ---pagebreak--- 3. On 18 November the College of Commissioners agreed to submit the proposal to the
   Standing Veterinary Committee (SVC) for an opinion. On 26 November the proposal
   was first discussed with the Member States in a working group of the SVC. On
   2 December the proposal was presented for a vote to the SVC. The SVC gave a negative
   opinion. Most Member States objected to the proposed procedure for establishing the
   TSE status of countries, which requires an opinion of the appropriate scientific
   committee and will be based on an assessment of the incident, propagation and human
   exposure risk. In proposing the classification of countries the Commission will base
   itself on the relevant scientific opinion taking the OIE Code on BSE into consideration.
   Most Member States feel that no clear criteria are provided for in this text. In addition,
   most Member States object to the complexity of the ensuing control system resulting
   from different lists of SRMs applicable in countries classified according to four
   categories of TSE status. Finally, several technical remarks were made.
   The results of the vote were:
   Against:     B, DK, DE, GR, FR, IRL, IT, L, P, FIN
   Abstain:     NL, AUS, SW, UK
   No vote:     SP (because of the absence of Spanish interpretation).
 ---pagebreak---                                           Proposal for a
                                     COUNCIL DECISION
      regulating the use of material presenting risks as regards transmissible spongiform
      encephalopathies and amending Commission Decisions 94/474/EC and 97/534/EC
                                    (Text with EEA relevance)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 89/662/EEC of 11 December 1989 concerning veterinary
checks in intra-Community trade with a view to the completion of the internal market1, as last
amended by Directive 92/118/EEC2, and in particular Article 9(4) thereof,
Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and
zootechnical checks applicable in intra-Community trade in certain live animals and products
with a view to the completion of the internal market3, as last amended by Directive 92/118/EEC,
and in particular Article 10(4) thereof,
Having regard to Council Directive 90/675/EEC of 10 December 1990 laying down
the principles governing the organisation of veterinary checks on products entering
the Community from third countries4, as last amended by Directive 96/43/EC5, and in particular
Article 19 thereof,
Having regard to the proposal from the Commission6,
(1)     Whereas pursuant to Directive 89/662/EEC and Directive 90/425/EEC, the
        Member State of origin or dispatch is required to implement on its territory the
        appropriate measures to prevent all situations likely to constitute a serious hazard to
        animals or to human health;
(2)     Whereas several distinct transmissible spongiform encephalopathies (TSEs) have been
        recognised for many years to occur separately in humans and animals; whereas bovine
        spongiform encephalopathy (BSE) was first recognised in bovine animals in 1986 and
        in following years was recognised to occur in other species of animals; whereas a
        new variant of Creutzfeldt-Jakob Disease (nv-CJD) was described in 1996;
        whereas evidence is accumulating that the agent causing BSE is identical to that
        causing nv-CJD;
    OJL 395, 30.12.1989, p. 13.
    OJL 62, 15.3.1993, p. 49.
    OJL224, 18.8.1990, p. 29.
    OJ L 373, 31.12.1990, p. 1.
    OJL 162, 1.7.1996, p. 1.
    OJC
 ---pagebreak--- (3) Whereas rules should be laid down concerning the production and placing on the
    market of live animals and products of animal origin with respect to removal of, or
    absence of, specified risk material on the basis of the risk classification of the country
    or region concerned; whereas, however, those rules should not apply to cosmetic or
    medicinal products or medical devices, or their starting materials or intermediate
    products, for which other specific rules apply; whereas they should also not apply to
    products of animal origin which do not pose a risk to animal or human health since
    they are intended for purposes other than human food, animal feed or fertiliser;
    whereas it is appropriate to ensure that products of animal origin excluded from the
    scope of this Decision are kept separate from those covered by it unless they meet at
    least the same health standards as the latter;
(4) Whereas existing Community Directives provide for the protection of public health in
    respect of the use of specified risk material in cosmetic or medicinal products and
    medical devices placed on the market in the Community; whereas, therefore, those
    products may be excluded from the scope of this Decision;
(5) Whereas a procedure should be established for the determination of the
    epidemiological status, with respect to BSE, of countries or regions, on the basis of
    the assessment of the incident, propagation and human exposure risk using
    information supplied to the Commission; whereas Member States and third countries
    which choose not to apply for their status to be determined should be placed in
    a category by the Commission on the basis of all information available to
    the Commission;
(6) Whereas at its general assembly in Paris on 29 May 1998, the Office International
    des Epizooties (OIE) adopted a revised version of its Animal Health Code on BSE
    (OIE Code on BSE); whereas Article 3.2.13.14 of that Code recommends that bovine
    brain, eyes, spinal cord, tonsils, thymus, spleen, intestines, dorsal root ganglia,
    trigeminal ganglia and bones, and protein products derived from them from cattle over
    six months of age originating from countries with a high incidence of BSE should not be
    traded between countries; whereas the same Article recommends that bovine brain, eyes,
    spinal cord and distal ileum and protein products derived from them from cattle over
    six months of age originating from countries with a low incidence of BSE and born
    before the feedban was effectively enforced, should not be traded between countries;
    whereas it further recommends that brains and spinal cord (list under study) and protein
    products derived therefrom, from cattle, originating from a country or zone that has not
    demonstrated a BSE free status and has not declared any indigenous cases of the
    disease, which were born before the date from which the ban on the feeding of
    ruminants with meat-and-bone meal derived from ruminants was effectively enforced,
    and which were at the time of slaughter aged over 30 months (under study) should not
    be traded between countries;
(7) Whereas the Code Commission of the OIE, following recommendations of the
    scientific Ad Hoc Group on BSE epidemiology, issued proposed amendments to the
    OIE Code on BSE in September 1998; whereas the effect of those amendments would
    be to require that those tissues, instead of not being traded, should not be used for
    the preparation of human food, animal feed, cosmetics, pharmaceuticals or
    medical devices;
 ---pagebreak--- (8)    Whereas the Scientific Veterinary Committee in its opinion of 21 October 1996,
       recommended on the basis of its risk assessment that specified risk materials, defined as
       brain, spinal cord and eyes from cattle, sheep and goats over one year of age and spleens
       from sheep and goats over six months of age, should be removed from all human food
       and animal feed chains in countries or regions where a potential risk was identified, and
       that, in the case of fallen bovine animals, sheep and goats, either the specified risk
       materials should be removed so that they do not enter any human food or animal feed
       chain, or the whole carcase should be destroyed;
(9)    Whereas the Scientific Steering Committee (SSC) adopted an opinion on
       9 December 1997; whereas in that opinion the SSC suggested a new and enlarged
       list of specified risk materials and proposed that those materials should be
       excluded temporarily from human and animal consumption depending on the
       geographical source;
(10)   Whereas on the basis of the advice of the Scientific Veterinary Committee of
       21 October 1996, in accordance with the risk assessment carried out by that Committee,
       the Commission adopted Decision 97/534/EC of 30 July 1997 on the prohibition of the
       use of material presenting risks as regards transmissible spongiform encephalopathies7;
       as last amended by Council Decision 98/248/EC8; whereas in the light of the new
       scientific advice and the development of international standards the list of specified
       risk materials laid down in Decision 97/534/EC is no longer appropriate;
(11)   Whereas certain ruminant tissues should be designated as specified risk materials on
       the basis of the pathogenesis of TSEs and the epidemiological status of the country or
       region of origin or residence of the animal concerned; whereas the specified risk
       materials should be removed and disposed of in a manner which avoids any risk to
       human or animal health; whereas, in particular, they should not be placed on the
       market for human food, animal feed or fertiliser; whereas, however, provision should
       be made for an equivalent level of health protection to be achieved by means of a test
       for TSEs carried out on individual animals; whereas slaughter techniques presenting a
       risk of causing brain material to contaminate other tissues should not be permitted in
       countries or regions other than those presenting the lowest risk of BSE; whereas it is
       necessary for practical and precautionary reasons to exclude the use of distal ileum and
       spleens from sheep and goats and, as appropriate, bovine animals, irrespective of age,
       and mechanically recovered meat from the skull and vertebral column of bovine
       animals, sheep and goats;
(12)   Whereas equivalent guarantees should be required for imports from third countries;
       whereas the situation as regards TSEs may vary between countries and the import
       requirements should therefore be adapted to the particular situation of the country
       of origin;
7
    OJL216, 8.8.1997, p. 95.
8
    OJL 102, 2.4.1998, p. 26.
 ---pagebreak--- (13)    Whereas Commission Decision 94/474/EC of 27 July 1994 concerning certain
       protection measures relating to bovine spongiform encephalopathy and repealing
        Decisions 89/469/EEC and 90/200/EEC9, as last amended by Decision 98/272/EEC10,
        and Decision 97/534/EC should be amended accordingly;
(14)    Whereas this Decision should be reviewed in the light of new scientific information with
        regard to risk of exposure to TSEs resulting from infectivity in animal species, age
        categories, tissues or materials not yet covered by this Decision;
(15)    Whereas the measures provided for in this Decision are not in accordance with the
        opinion of the Standing Veterinary Committee; whereas they must therefore be adopted
        by the Council,
HAS ADOPTED THIS DECISION:
                                              Article 1
                                                Scope
1.      This Decision regulates the use of material presenting risks as regards certain
        transmissible spongiform encephalopathies (TSEs). It shall apply to the production and
        placing on the market of live animals and products of animal origin.
2.      This Decision shall not apply to:
        (a)     cosmetic or medicinal products or medical devices, together with their starting
                materials or intermediate products;
        (b)     products not destined for use in human food, animal feed or fertilisers,
                together with their starting materials or intermediate products;
        (c)     products of animal origin destined for exhibition, teaching, research, special
                studies or analysis.
3.      In order to avoid cross-contamination or substitution of the products of animal origin
        referred to in paragraph 1 by those referred to in paragraph 2, they shall be kept
        separate at all stages unless the latter are produced under at least the same conditions of
        health protection in respect of TSEs.
                                              Article 2
                                            Definitions
For the purposes of this Decision, the following definitions shall apply:
(1)     transmissible spongiform encephalopathies: all TSEs with the exception of those
        occurring in humans;
9
    OJL 194, 29.7.1994, p. 96.
10
    OJL 122, 24.4.1998, p. 59.
 ---pagebreak--- (2) placing on the market: any operation the purpose of which is to supply live animals,
    or products of animal origin covered by this Decision to a third party for sale, or any
    other form of transfer against payment or free of charge to a third party and storage
    with a view to supply to a third party, regardless of whether the operation takes place
    within a Member State, between Member States or from a third country to a
    Member State;
(3) products of animal origin: any products derived from or containing a product derived
    from any animal;
(4) starting materials: raw materials or any other product of animal origin out of
    which, or with the help of which, the products referred to in Article l(2)(a) and (b)
    are produced;
(5) competent authority: the central authority of a Member State competent to ensure
    compliance with the requirements of this Decision or any authority to which that
    central authority has delegated such competence;
(6) categories: the categories set out in Annex I;
(7) specified risk material: those tissues specified in Annex III; unless otherwise
    specified, it does not include products containing or derived from those tissues;
(8) skull: the bones of the head, including the bones of the lower jaw.
                                         Article 3
                     Classification for determination of BSE status
1.  Member States and third countries, or regions thereof, shall be placed in one of four
    categories in accordance with Annex I.
2.  Member States or third countries shall submit an application to the Commission,
    accompanied by the information laid down in Annex II for their BSE status to
    be determined.
3.  The Commission, acting in accordance with the procedure laid down in Article 17 of
    Directive 89/662/EEC, shall take a decision in respect of each application to place the
    applicant Member State or third country, or region thereof, in one of four categories.
    The Commission shall take its decision within six months after the submission of the
    application. If the Commission finds that the application does not include all the
    information laid down in Annex II, it shall ask for additional information within a
    delay to be specified. The final decision shall then be taken within six months after
    submission of the complete information.
4.  Member States or third countries which have not submitted an application in
    accordance with paragraph 2 within six months after the date referred to in the
    first paragraph of Article 11 shall be placed in a category by the Commission on the
    basis of all information available to the Commission.
 ---pagebreak--- 5.  Member States shall communicate any changes in the circumstances relevant to their
    BSE status to the Commission without delay. The eligibility of third countries to
    export to the Community live animals or products of animal origin, for which this
    Decision provides specific rules, shall be conditional upon their undertaking in
    writing to communicate any changes in the circumstances relevant to their BSE status
    to the Commission without delay.
6.  The decisions referred to in paragraphs 3 and 4 shall be taken after consultation of the
    appropriate scientific committee and shall be based on an assessment of the incident,
   propagation and human exposure risk, taking into consideration the recommendations
    oftheOIECodeonBSE.
                                        Article 4
                                 Specified risk material
1. Member States shall ensure that after 30 September 1999 the specified risk materials
   are, under the direct supervision of an official of the competent authority, removed
   from animals which were slaughtered or which died on their territory and disposed of
   in accordance with Annex III. They shall not be placed on the market for human food,
   animal feed or fertilisers after 30 September 1999.
2. Paragraph 1 shall not apply where animals have been subjected to a test which has been
   approved by the Commission in accordance with the procedure laid down in Article 17
   of Directive 89/662/EEC, applied under the conditions laid down in Annex III, point 8,
   and the results of that test were negative.
3. In Member States, or regions thereof, which are not placed in Category 1, the
   following slaughter techniques shall not be used on bovine, ovine or caprine animals
   whose meat is destined for human or animal consumption:
   (a)      stunning or killing by means of a gas injected into the cranial cavity;
   (b)      laceration after stunning of central nervous tissue by means of an elongated
            rod-shaped instrument introduced into the cranial cavity.
4. The use of the skull and vertebral column of bovine, ovine and caprine animals for the
   production of mechanically recovered meat in Member States, or regions thereof which
   are not placed in Category 1 shall be prohibited after 30 September 1999. This shall not
   apply to animals which will are subjected to a test in accordance with Annex III,
   point 8.
5. By way of derogation from paragraph 1 the Commission, acting in accordance with
   the procedure laid down in Article 17 of Directive 89/662/EEC, may take a decision
   in respect of the date of effective enforcement of the prohibition on the feeding of
   mammalian protein to ruminants in each Member State or region thereof placed in
   Category 2 or 3, and allow the application of paragraph 1 to be confined to animals
   which were born before that date in those countries or those regions.
 ---pagebreak---                                            Article 5
                                    Placing on the market
1.     Where bovine, ovine or caprine animals coming from countries, or regions thereof,
       placed in one category are to be slaughtered after 30 September 1999 in the territory
       of Member States in a lower category, paragraphs 2, 3 and 4 shall apply.
2.     The Member State of destination shall ensure that the specified risk materials are
       removed from the animals referred to in paragraph 1 and destroyed in accordance with
       Article 4. Those animals shall be slaughtered in slaughterhouses approved for that
       purpose by the competent authority and at the end of the normal slaughtering process.
3.     The Member State of dispatch shall ensure that:
       (a)     for bovine animals, the animal health certificates referred to in Annex F to
               Council Directive 64/432/EEC11 are supplemented by the following words to
               be entered in the section "Health data concerning bovine animals":
               "The BSE category of the animals listed below is Category ... (*);
               (*)      Complete as appropriate with 1,2, 3 or 4.";
       (b)     for ovine or caprine animals the animal health certificates corresponding to
               Model III in Annex E to Council Directive 91/68/EEC12 shall be supplemented
               by the following words to be entered in section V "Health information":
               "BSE category of the animals listed below: Category ... (*);
               (*)      Complete as appropriate with 1, 2, 3 or 4.";
       (c)     for all animals, the competent authority of the Member State of destination is
               informed of the BSE category of the animals in each consignment by means of
               a specifically coded ANIMO message or by fax.
4.     The third country of dispatch shall ensure that:
       (a)     for bovine, ovine and caprine animals the appropriate certificates, as required by
               Community legislation, are supplemented by the following words:
               "The BSE category of the animals listed below is Category ... (*).
               (*)      Complete as appropriate with 1,2, 3 or 4.";
       (b)     the competent authority of the Member State of destination is informed of the
               BSE category of the animals in each consignment by means of a specifically
               coded ANIMO message or by fax.
"  OJ L 121, 29.7.1964, p. 1977/64.
12
   OJL 46, 19.2.1991, p. 19.
                                               10
 ---pagebreak--- Products listed in Annex IV which contain material derived from bovine, ovine or
caprine animals and are imported into the Community after 30 September 1999 shall be
accompanied by the appropriate certificate, as required by Community legislation,
supplemented by the following words:
"The products originate from a country, or region within a country in
BSE category... (*). This category was established by Commission Decision
[.../...](**).
(*)       Complete as appropriate with 1,2, 3 or 4
(**)      Complete".
Where those products are imported from third countries, or regions thereof, in
Categories 3 and 4 or from third countries, or regions thereof, in Category 2 in which
BSE has occurred, the appropriate certificates, as required by Community legislation,
shall be supplemented by one of the following declarations signed by the competent
authority of the country of production:
"The product does not contain, and is not derived from, specified risk material as
defined in Decision [.../...], produced after 30 September 1999, or mechanically
recovered meat obtained from the skull or vertebral column of bovine, ovine or caprine
animals, produced after 30 September 1999. The animals have not been slaughtered by
stunning or killing by means of a gas injected into the cranial cavity, or slaughtered by
laceration after stunning of central nervous tissue by means of an elongated
rod-shaped instrument introduced into the cranial cavity"
or,
"The product contains, or is derived from, material produced after 30 September 1999 of
bovine, or as appropriate, ovine or caprine animals which were tested and found
negative for the presence of BSE using a test which was approved in accordance with
Commission Decision [.../...]".
Any reference to "products" in this Article is a reference to the products listed in
Annex IV, not to other products containing or derived from those products.
By way of derogation from paragraph 5, the Commission acting in accordance with
the procedure laid down in Article 17 of Directive 89/662/EEC, may take a decision
in respect of the date of effective enforcement of a prohibition on the feeding of
mammalian protein to ruminants in any third country, or region thereof, in Category 2
or 3, and allow the application of paragraph 5 to be confined to specified risk
materials derived from animals which were born before that date in those countries or
those regions.
                                         11
 ---pagebreak---                                              Article 6
                                         Official controls
1.      Member States shall carry out frequent official controls to verify the correct application
        of this Decision and ensure that measures are taken to avoid contamination, particularly
        in slaughterhouses, cutting plants, animal waste processing plants, high risk processing
        plants or premises authorised by the Member States in accordance with Article 7 of
        Council Directive 90/667/EEC13, points of sale to the consumer and storage facilities.
2.      Member States shall in particular set up a system to ensure and check that:
        (a)     specified risk materials used for products referred to in Article 1(2) are
                exclusively used for the authorised purpose;
        (b)     where live bovine, ovine or caprine animals are received by Member States
                placed in a lower BSE category than that of the animals, those animals remain
                under official supervision until slaughter or dispatch from their territory.
                                             Article 7
                                 Further precautionary measures
Member States may take precautionary measures going beyond the measures provided for in
this Decision in relation to animals slaughtered on their own territory.
                                             Article 8
                                            Other acts
This Decision shall be without prejudice to the provisions of Council Decision 98/256/EC14,
Decision 94/474/EEC and Commission Decision 98/653/EC15.
                                             Article 9
                                          Amendments
1.      Article 3(3) of Decision 94/474/EEC is hereby amended as follows:
        (a)     Point (a) is deleted;
        (b)     In point (c), the words "scientific tests are used to monitor the implementation
                of (a) and (b)" are replaced by "scientific tests are used to monitor the
                implementation of (b)".
13
    OJL 363, 27.12.1990, p. 51.
14
    OJL 113, 15.4.1998, p. 33.
15
     OJL311,20.11.1998,p.23.
                                                  12
 ---pagebreak--- 2.      Article 10 of Decision 97/534/EC is replaced by the following:
                                          "Article 10
        This Decision shall apply from such time as the Commission, acting in accordance
        with the procedure laid down in Article 17 of Directive 89/662/EEC, shall determine".
                                          Article 10
                                            Review
This Decision and the Decisions referred to in Article 3 shall be reviewed regularly in the light
of new epidemiological information and scientific information with regard to criteria
determining the level of risk in regions, and the risk of exposure to TSEs resulting from
infectivity in other animal species, age categories, tissues or materials. Where necessary this
Decision shall be amended after consultation of the appropriate Scientific Committee and in
accordance with the procedure laid down in Article 17 of Directive 89/662/EEC.
                                          Article 11
                                         Application
This Decision shall apply from 1 January 1999.
It does not apply to products which were produced before 1 October 1999 referred to in this
Decision, containing or derived from specified risk materials.
                                           Article 12
                                          Addressees
This Decision is addressed to the Member States.
Done at Brussels,                                                     For the Council
                                                                      The President
                                                13
 ---pagebreak---                                                                                   ANNEXI
                                   CLASSIFICATION
I.   For the purpose of determining the BSE status of Member States or third countries,
     or regions within Member States or third countries, the following categories
     are established:
    A.       MEMBER STATES
             Category 1 (BSE free)
             Category 2 (provisionally BSE free)
             Category 3 (low BSE risk)
             Category 4 (high BSE risk)
    B.       THIRD COUNTRIES
             Category 1 (BSE free)
             Category 2 (provisionally BSE free)
             Category 3 (low BSE risk)
             Category 4 (high BSE risk)
II. Where an animal moves from one category of a country or region to another, it shall
    acquire or retain the highest numerical BSE category of any country or region in which
    it has been kept for more than 24 hours, unless adequate guarantees can be provided that
    the animals were not fed with feed from that country or region with the highest
    numerical BSE category.
                                            14
 ---pagebreak---                                                                                      ANNEX II
     Information to be submitted in support of an application for recognition of risk
                                 classification under Article 3
All data must be provided on an annual basis and preferably from 1980 onwards, but at least
from 1988.
Applicant States must make every effort to provide comprehensive and consistent
information. Data which are not provided or are incomplete or are considered as
unsatisfactory may be completed by reference to other sources of information available to the
Commission, or may have to be replaced by a worst-case assumption for the purposes of a
risk assessment.
Information must be provided on:
1.      Structure and dynamics of the bovine, ovine and caprine animal populations
(a)     absolute numbers of animals per species and breed, alive and at time of slaughter;
(b)     age distributions of animals per species and breed, sex and type;
(c)     age distribution of animals per species and breed, sex and type at time of slaughter;
(d)     geographical distribution of the animals by species and breeds;
(e)     geographical distribution of the animals by husbandry systems, herd sizes and
        production purposes;
(f)     system of identification and capacities for tracing of animals and a system of control
        and possible sanctions in accordance with Community legislation on animal
        identification and registration.
2.      Animal trade
(a)     imports and exports;
(b)     trade within the geographical area;
(c)     imports of embryos and semen;
(d)     use made of imported animals, embryos or semen;
(e)     mechanisms used by slaughterhouses to identify animals and their origins, as well as
        data from these procedures.
                                                15
 ---pagebreak--- 3.  > Animal feed
(a)  domestic production of Meat and Bone Meal (MBM), and its use per species and
     husbandry system (in particularly the proportion of the domestically produced MBM
     fed to bovine, ovine and caprine animals);
(b)  imports of MBM, specifying country of origin, and its use per species and
     husbandry system (in particularly the proportion of that MBM fed to bovine, ovine
     and caprine animals);
(c)  exported MBM, specifying country of destination.
4.   Meat and bone meal (MBM) bans
(a)  complete description;
(b)  dates of introduction;
(c)  actual implementation, policing and compliance figures;
(d)  possibilities of cross-contamination with other feed.
5.   Specified bovine offal (SBO) and specified risk materials (SRM) bans
(a)  complete description;
(b)  dates of introduction;
(c)  actual implementation, policing and compliance figures.
6.   Surveillance of TSE, with particular reference to BSE and scrapie
(a)  incidence of laboratory confirmed cases of BSE and scrapie;
(b)  age distribution, geographical distribution, and countries of origin of cases;
(c)  incidence of neurological disorders in which TSE could not be excluded on clinical
     grounds in any animal species;
(d)  methodologies and programmes of surveillance and recording of clinical cases of BSE
     and scrapie, including awareness training for farmers, veterinarians, supervisory
     bodies and authorities;
(e)  incentives for reporting cases, compensation and reward schemes;
(f)  methodologies of laboratory confirmation and recording of suspect cases of BSE
     and scrapie;
                                             16
 ---pagebreak--- (g) strains of BSE and scrapie agents possibly involved;
(h) existing systems or current plans for targeted active surveillance.
7.  Rendering and feed processing
(a) all rendering and feed processing systems used;
(b) nature of the records of rendering and processing plants;
(c) quantitative and qualitative parameters of MBM and rendered animal fat production
    by each of the processing systems;
(d) the geographical areasfromwhich the rendered materials originate;
(e) the type of raw material used;
(f) parameters on separate processing lines for materials from healthy and
    suspected animals;
(g) transport and storage systems for MBM or feed containing MBM.
8.  BSE or scrapie related culling
(a) culling criteria;
(b) date of introduction of the culling scheme and of any subsequent modification;
(c) animals culled (details as specified in point 1);
(d) sizes of herds in which animals were culled.
                                             17
 ---pagebreak---                                                                                 ANNEX III
                            SPECIFIED RISK MATERIAL
    The following tissues shall be designated as specified risk materials depending on the
    category of the country of origin or residence of the animal, determined in accordance
    with Article 3:
    CATEGORY 1
    No tissues are designated as specified risk materials.
    CATEGORY2
    In countries, or regions within countries, placed in Category 2, the following are only
    designated as specified risk materials where BSE has occurred16:
    (a)    the brain and spinal cord of:
                    bovine animals aged over 30 months,
                    ovine and caprine animals which are aged over 12 months or have a
                    permanent incisor erupted through the gum;
    (b)     the distal ileum and spleen of ovine and caprine animals of all ages.
    CATEGORY3
                                         i
    (a)     the entire head excluding the tongue, including the brain and dura mater,
            pituitary gland, eyes, trigeminal ganglia and tonsils; the spinal cord and dura
            mater of bovine animals aged over six months and of ovine and caprine
            animals aged over 12 months;
    (b)     the distal ileum of bovine, ovine and caprine animals, and spleen of ovine and
            caprine animals of all ages.
    CATEGORY4
    (a)     the entire head excluding the tongue, including the brain and dura mater,
            pituitary gland, eyes, trigeminal ganglia and tonsils; the thymus; the intestines
            from the duodenum to the rectum; the vertebral column, including dorsal root
            ganglia, unless specific measures have been taken covering meat-and-bone
            meal and maternal transmission and in the light of the latest available
            scientific advice; spinal cord and dura mater of bovine animals aged over
            six months and of ovine and caprine animals aged over 12 months;
pending OIE confirmation.
                                            18
 ---pagebreak--- (b)      other bones of bo vine animals aged over 30 months;
(c)      the distal ileum and spleen of bovine, ovine and caprine animals of all ages.
Pursuant to a Decision in respect of the date of effective enforcement of a prohibition
on the feeding of mammalian protein to ruminants in each country, or region of within
a country, placed in Category 2 or 3, as referred to in Articles 4(5) and 5(6), the
application of the provisions related to specified risk materials may be confined to
those derived from animals which were born before that date in those countries or
those regions.
Member States shall ensure that the specified risk materials are removed
at slaughterhouses.
However, in Member States or regions within Member States that are not placed in
Category 4, the removal and subsequent destruction according to point 5 of specified
risk materials from raw material for the production of rendered ruminant fat derivatives
is not required provided that the derivatives are produced in accordance with Annex V.
By way of derogation from point 3, Member States may allow the removal of:
(a)      specified risk material at cutting plants, high risk processing plants or premises
         referred to in Article 7 of Directive 90/667/EEC, under the direct supervision
         of an official of the competent authority. Those establishments shall be
         approved for that purpose by the competent authority;
(b)      the vertebral column or bones at the point of sale to the consumer on
         their territory.
Member States shall set up a system to ensure and check that, where the removal of
specified risk materials takes place at establishments other than slaughterhouses, those
materials are completely separated from other waste, are collected separately and are
disposed of in accordance with point 5.
Member States shall ensure that specified risk material is stained with a dye
immediately on removal, and that all specified risk material is completely destroyed:
 (a)      by direct incineration; or,
 (b)      provided that the colour of the dye is detectable after processing, by processing
          followed by:
          (i)     incineration;
          (ii)    burning as fuel; or,
          (iii)   another method, which precludes all risk of transmission of a TSE, and is
                  authorized and supervised by the competent authority.
                                           19
 ---pagebreak--- Where bovine, ovine or caprine animals have died or have been killed in the context
of disease control measures, Member States may allow disposal of the entire body of
those animals without removal of the specified risk materials.
Member States may derogate from the provisions of points 3 and 5 to allow the burning
or burial of specified risk material or entire bodies, without prior staining, or, as
appropriate, removal of the specified risk materials, in the circumstances set out in
Directive 90/667/EEC.
The application of a test as an alternative to the removal of specified risk materials
may be authorised under the following conditions:
(a)     tests are carried out in slaughterhouses on all animals eligible for the removal
        of specified risk materials;
(b)     no bovine, ovine or caprine product intended for human food or animal feed
        leaves the slaughterhouse before the results of the tests on all slaughtered
        animals produced in the same batch have been received and accepted by the
        competent authority;
(c)     when a post-slaughter test gives a positive result, all bovine, ovine and caprine
        material produced in the same batch is destroyed in accordance with point 5.
Member States shall carry out frequent official controls, particularly in slaughterhouses,
cutting plants, animal waste processing plants, high risk processing plants or premises
referred to in Article 7 of Directive 90/667/EEC, points of sale to the consumer and
storage facilities, and shall ensure that measures are taken to avoid contamination.
                                          20
 ---pagebreak---                                                                                              ANNEX IV
The products referred to in Article 5(5) are:
(a)     fresh meat: fresh meat as defined by Council Directive 64/43 3/EEC on health
         problems affecting intra-Community trade in fresh meat17;
(b)      minced meat and meat preparations: minced meat and meat preparations as defined
         by Council Directive 94/65/EC18;
(c)      meat products and other products of animal origin: meat products and other products
         of animal origin as defined by Council Directive 77/99/EEC19;
(d)      milk products, as defined by Council Directive 92/46/EEC20, which are destined for
         human consumption and containing gelatin or rendered animal fat;
(e)      milk products, as defined by Council Directive 92/118/EEC21, which are destined for
         animal consumption and containing gelatin or rendered animal fat;
(f)   fishery products, as defined by Council Directive 91/493/EEC22, which are destined
         for human consumption and containing gelatin or rendered animal fat;
(g)      egg products, as defined by Council Directive 89/437/EEC23, which are destined for
         human consumption and containing gelatin or rendered animal fat;
Ça)      snails or frogs' legs, as referred to by Council Directive 92/118/EEC, which are
         destined for human consumption and containing gelatin or rendered animal fat;
(i)      renderedfats, as referred to by Council Directive 92/118/EEC;
(j)      gelatin, as referred to by Council Directive 92/118/EEC;
(k)      petfood, as referred to by Council Directive 92/118/EEC;
(1)      processed animal protein, as referred to by Council Directive 92/118/EEC;
(m)      bones and bone products, as referred to by Council Directive 92/118/EEC;
(n)      raw material for the manufacture of animal feedingstujfs, as referred to by
         Council Directive 92/118/EEC.
17
    OJ 121,29.7.1964, p. 2012/64. Directive as last amended by Directive 95/23/EC (OJ L 243, 11.10.1995,
    P- 7).
18
    OJL 368, 31.12.1994, p. 10.
19
    OJL26, 31.1.1977, p. 85.
20
    OJ L 268, 14.9.1992, p. 1.
21
    OJL62, 15.3.1993, p.49.
22
    OJL268,24.9.1991, p. 15.
23
    OJL212, 22.7.1989, p. 87.
                                                      21
 ---pagebreak---                                                                                      ANNEXV
Tallow derivatives may be used for the production of human food, animal feed or fertilisers
provided that they are produced by an appropriate, validated and strictly certified method
such as:
1.     Transesterification or hydrolysis at not less than 200°C for not less than 20 minutes
       under pressure (glycerol, fatty acids and fatty acid esters production); or
2.      Saponification with NaOH 12 M (glycerol and soap production):
               in a batch process: at not less than 95°C for not less than three hours; or,
               in a continuous process: at not less than 140°C, 2 bars for not less than
               eight minutes, or equivalent.
Moreover, other tallow derivatives (e.g. fatty alcohols, fatty amines, fatty amides) produced
from the abovementioned and submitted to further processes may also be used.
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 ---pagebreak---                                                                 ISSN 0254-1475
                                                           COM(98) 749 final
                                             DOCUMENTS
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