CELEX: 51998PC0161
Language: en
Date: 1998-03-09
Title: Proposal for a Council Decision concerning emergency measures to protect against bovine spongiform encephalopathy, amending Decision 94/474/EC and repealing Decision 96/239/EC

COMMISSION OF THE EUROPEAN COMMUNITIES
                                                Brussels, 09.03.1998
                                                COM(1998) 161 final
                                Proposal for a
                            COUNCIL DECISION
concerning emergency measures to protect against bovine spongiform encephalopathy,
          amending Decision 94/474/EC and repealing Decision 96/239/EC
                       (presented by the Commission)
 ---pagebreak---  ---pagebreak---                          KXI'LANATOKYMKMORANDIJM
Aller announcement by the UK authorities of a |>ossible link between BSE and (Ml),
the Commission adopted on the 27th of March 19%, the Decision 96/239/EC which
prohibits dispatch from the United Kingdom of live bovine animals and bovine
products. In the Council of 22 June 1996, leading to the Florence Agreement, the
preconditions for the step by step lifting of the prohibitions were set out. The
implementation of an effective disease eradication plan, including selective slaughter
of potentially exposed animals and culling of animals over 30 months of age and their
destruction, is central in the preconditions. One of the main steps within the
framework of is a gradual removing of the export ban for animals and meat from
certified herds, i.e. without a history of BSE and no exposure to infected meat and
bone meal.
At the end of June 1996 the plan to eradicate BSE of the United Kingdom was
adopted. Satisfactory progress to eradicate the disease has been made. At the peak of
the epidemic, in 1992, 37.280 BSE cases were confirmed, last year a substantially
reduced number of 3.396 BSE cases were confirmed. To date over 3 million cattle
have been slaughtered and destroyed under the various programmes of the eradication
plan.
The United Kingdom first put forward in February 1997 a proposal for an Export
Certified Herds Scheme, with a view to lifting the restrictions. Following rejection by
the Scientific Veterinary Committee in June, the United Kingdom put forward a
modified proposal in July.
In the summer of 1997 new information on a large scale fraud with UK beef emerged.
Investigations by the UCLAF and the FVO showed deficiencies in the official control
of production of beef in the United Kingdom for dispatch from their territory,
 following this information the strategy on reinforcing veterinary controls in order to
prevent fraud has been decided, and was communicated through the (fourth) progress
report to the temporary Committee of the European Parliament on the follow-up of
                                       ±
 ---pagebreak---  recommendations on BSE in October. These conditions for a reinforced veterinary
 control system have been incorporated in the proposal.
 l'art of the proposal was already presented to the Member States in June 1997. At that
 stage only the withdrawal for the exemption for dispatch of gelatine from cattle
 slaughtered in the UK and some clarifications were proposed. The reinforced controls,
 the partial lifting of the prohibitions and further clarifications became opportune only
 recently, and therefore, were included in the present proposal.
This proposal was first discussed in a working group of the standing veterinary
committee on 29 January 1998, where it was generally commended. To the contrary it
met strong opposition in the Standing Veterinary Committee itself.            The crucial
element in the discussion was the acceptance of non-eligible animals in eligible herds.
This is endorsed by the Scientific Veterinary Committee on condition that non-
eligible animals cannot enter the scheme. It is justified by the assumption that
transmission from animal to animal does not take place. In the proposal non-eligible
animals are accepted in eligible herds, these non-eligible animals cannot enter the
scheme.
In the Standing Veterinary Committee meeting of 4 March Denmark, Greece,
Ireland, Italy, The Netherlands, Austria, Portugal, Finland, Sweden and, of-course,
the United Kingdom supported the proposal. Belgium, Germany, Spain and
Luxembourg voted against because they object to the possibility in the Export
Certified Herds Scheme for export from eligible herds to which ineligible animals
have been added. France abstained, not because they reject the proposal in principle,
but because they feel that there are too many outstanding technical issues still to
settle.
The Commission not having received a favourable opinion from the Standing
Veterinary Committee, is required under Article 17 of Directive 89/662 to submit a
proposal to the Council without delay.
                                            1.
 ---pagebreak---                                        PROPOSAI, for a
                                     COUNCIL DECISION
                                              of
    concerning emergency measures ui^rotecl against bovine spongiform encephalopathy,
               amending Decision 94/474/EC and repealing Decision 96/239/EC
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and
xoolechnical checks applicable in intra-Community trade in certain live animals and products
with a view to the completion of the internal market1, as last amended by Directive
92/118/EEC, and in particular Article 10(4) thereof,
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 market3, as last
amended by Directive 92/118/EEC, and in particular Article 9(4) thereof,
I laving regard the proposal of the Commission,
i
        OJ No L 224, 18.8.1990, p.29.
        OJ No L 62, 15.3.1993, p.49.
        OJ No L 395, 30.12.1989, p.13.
 ---pagebreak---  (I )   Whereas new information has been published in the I Initctl Kingdom further supporting
       the hypothesis that exposure to the bovine spongiform encephalopathy (BSE!) agent is
       linked to the new variant of Creulzfcldl Jacob Disease (CJD) in humans; whereas on 16
       September 1997 the Spongiform Encephalopathy Advisory Committee (SEAC) of the
       United Kingdom concluded that recent research provided compelling new evidence that
       the agent which causes BSE is identical to the agent which causes the new variant of
       CJD in humans; whereas on 18 September 1997 the Advisory Committee on Dangerous
       Pathogens (ACDP) concluded that the BSE agent should now be classified as a human
       pathogen;
 (2)   Whereas, in those circumstances and as an emergency measure, it is appropriate to
       prohibit temporarily the dispatch to the other Member States of all bovine animals from
       the United Kingdom and of all products consisting entirely or in part of, or
       incorporating materials derived from, bovine animals slaughtered in the United
       Kingdom which are liable to enter the human food or animal feed chains or are destined
       for use in cosmetic, pharmaceutical or medical products; whereas in order to prevent
      deflections of trade, the same prohibitions should also apply to exports to third
      countries;
(3)   Whereas, in order to protect animal and human health in the Community, the
      Commission adopted Decision 94/474/EC of 27 July              1994 concerning certain
      protection measures relating to bovine spongiform encephalopathy and repealing
      Decisions 89/469/1 -EC and 90/200/1 «EC, as last amended by Decision 95/287/EC\
      Decision 92/290/EEC of 14 May 1992 concerning certain protection measures relating
      to bovine embryos in respect of bovine spongiform encephalopathy (BSE) in the United
      Kingdom6, as amended by the Act of Accession of Austria, Finland and Sweden,
      Decision 94/381/EC of 27 June 1994 concerning certain protection measures with
      regard to bovine spongiform encephalopathy and the feeding of mammalian derived
4
        O J N o L 194, 29.7.1994, p.96.
5
        O J N o L 181, 1.8.1995, p.40.
6
        O J N o L 152,4.6.1992, p.37.
 ---pagebreak---       protein7, as amended by Decision 95/60/EC8, and Decision 96/449/EC of 18 July 1996
      on the approval of alternative heat treatment systems for processing animal waste with a
       view to the inactivation of spongiform encephalopathy agents";
 (4)   Whereas the United Kingdom has taken measures as a result of the publication of
      information on certain cases of CJD in that Member State;
 (5)  Whereas the United Kingdom has banned the use of mammalian meat-and-bone meal,
      regardless of ils origin, for feeding farm animals; whereas it is necessary to provide that
      mammalian meat-and-bone meal and farm animal feed and fertilizers containing
      mammalian meat-and-bone meal, which by their nature could enter the farm animal
      feed chain, may not be dispatched from the United Kingdom;
 (6)  Whereas the risk of transmissible spongiform encephalopathies (TSEs) entering the
      human food or animal feed chains through the consumption of protein derived from
      domestic carnivores is considered low; whereas that risk can be further reduced by
      requiring that domestic carnivores are not fed mammalian meat-and-bone meal
      originating in the United Kingdom; whereas it is therefore appropriate to provide that
      food for domestic carnivores which is produced in the United Kingdom but contains no
      mammalian meat-and-bone meal originating in that country may be dispatched from its
     territory to other Member Slates or to third countries;
(7)  Whereas the United Kingdom has taken measures to destroy certain bovine tissues;
(8)  Whereas Commission Decision 96/239/EC of 27 March 1996 on emergency measures
     to protect against bovine spongiform encephalopathy10, prior to its amendment by
     Decision 96/362/EC", prohibited the dispatch from the United Kingdom to other
       O J N o l , 172, 7.7.1994, p. 23.
       O J N o L 55, 11.3.1995, p.43.
       OJNoL 184, 24.7.1996, p.43.
10
       O J N o L 78, 28.3.1996, p.47.
li
       OJ No LI 39, 12.6.1996, p. 17.
 ---pagebreak---      Member Slates and to third countries, in particular, of bovine semen, and certain other
     products from the United Kingdom obtained from bovine animals slaughtered in Ihe
      United Kingdom which are liable to enter the animal feed or human food chains and
     materials destined for use in medicinal products, cosmetics or pharmaceutical products;
(9)   Whereas the Scientific Veterinary Committee was consulted on 18 April 1996 and on
     26 April 1996; whereas in the opinion of that Committee, bovine semen is considered
     to be safe for animal health with respect to BSE!;
(10) Whereas the Scientific Committee on Cosmetology was consulted on Ihe safety of
     certain bovine products on 11 April 1996; whereas the Liaison Committee of F!uropean
     Associations of the Perfume, Cosmetic Products and Toiletries Industries (Colipa) has
     recommended its members not to use source materials from United Kingdom bovine
     animals; whereas that Committee has declared that its members follow that
     recommendation; whereas Commission Directive 97/1/EC of 10 January 1997 adapting
     to technical progress Annexes II, III, VI, and VII of Council Directive 76/768/EEC on
     the approximation of the laws of the Member States relating to cosmetic products l2, has
     provisionally prohibited the placing on the market of cosmetic products containing
     certain tissues and fluids;
(11) Whereas the Scientilic Committee for Food was consulted on the safety of certain
     bovine products on 15 April 1996;
(12) Whereas the Committee for Proprietary Medicinal Products was consulted on 16 April
     1996; whereas the pharmaceutical sector had already introduced measures relating to
     the sourcing of materials and their treatment; whereas every medicinal product
     undergoes a pre-marketing approval before it is placed on the market by virtue of which
     the treatment process of any raw material is evaluated; whereas at the request of the
     F!uropean Medicines Evaluation Agency, all Community marketing authorization
     holders, or applicants with a positive opinion from the Committee for Proprietary
12
       O J N o L 16, 18.1.1997, p.85.
 ---pagebreak---         Medicinal Products or the Committee for Veterinary Medicinal Products, have
        continued that the products concerned do not contain bovine tissue of United Kingdom
        origin;
  (13) Whereas subsequently, additional information was made available in order to facilitate
        a more complete risk assessment; whereas, on that basis, the Scientific Veterinary
        Committee on 26 April 1996 concluded that a combination of appropriate sourcing of
        bovine materials used and the application of minimum processing standards which have
        been shown effectively to inactivate the BSE agent together give good reassurances
        about the safety of those materials for food or cosmetic use; whereas, consequently, the
        Scientific Veterinary Committee has recommended safety parameters for the production
        of those materials which are therefore considered to be safe;
 (14) Whereas the Commission accordingly considered that certain products, such as gelatin
       and tallow, were safe;
 (15) Whereas in 1988 the United Kingdom introduced a requirement for animals affected
       with BSE to be completely destroyed; whereas the Council, at its meeting on 1, 2 and 3
       April 1996, concluded that bovine animals over the age of 30 months should not enter
       the human food or animal feed chains or be used for cosmetic or pharmaceutical
       products; whereas such animals should not be used as source materials for certain
       bovine products;
(16) Whereas furthermore, certain bovine tissues should not be used as source materials for
      those products;
(17) Whereas Decision 96/362/EC amended Decision 96/239/EC to exempt certain products,
      such as gelatin, tallow and bovine semen, from the prohibition;
(18) Whereas the Scientific Veterinary Committee at its meeting on 17 July 1996 endorsed
      the report of the sub-Group for BSE of 26 June 1996, where it recommended that the
 ---pagebreak---        risk assessment for gelatin established by the Scientific Veterinary Committee on 26
       April 1996 be reappraised in the light of the uncertainties as to the inactivation of the
       BSE agent, due note being taken of the requirements of Decision 96/362/EEC;
 (19) Whereas Decision 96/362/EC laid down certain preconditions which had to be met
       before the United Kingdom could dispatch from its territory gelatin made from raw
       materials from bovine animals; whereas those preconditions have not been fulfilled and
       such dispatch has not been authorized; whereas, however, in order to regularize the
       situation, pending further scientific knowledge and advice, it is appropriate to withdraw
       the possibility of dispatch of gelatin made from raw materials from bovine animals
       slaughtered in the United Kingdom for human food, animal feed, cosmetics,
       pharmaceutical and medical purposes; whereas that is in conformity with the advice
       from the Multi-disciplinary Scientific Committee of 3 April 1997, according to which
       no production can be considered safe if the base material used for gelatin production is
       potentially infectious;
(20) Whereas the United Kingdom should be permitted to dispatch from its territory gelatin
      and di-calcium phosphate for technical purposes made from raw material from bovine
      animals slaughtered in the United Kingdom, provided that it is suitably labelled;
(21) Whereas the United Kingdom should also be permitted to dispatch from its territory
      gelatin produced from raw material from bovine animals not slaughtered in the United
      Kingdom; whereas the United Kingdom has introduced a system of traceability for such
      gelatin to ensure that the origin of the raw material is identifiable; whereas the
      Community rules should be supplemented by formally introducing a system of
      traceability; whereas such a system should be introduced for other products which are
      exempted from the overall ban; whereas a system of labelling should also be
      introduced;
(22) Whereas it is necessary to provide that products from bovine animals not slaughtered in
      the United Kingdom should come from approved establishments under official
 ---pagebreak---        veterinary control which have a system in place to ensure traceability to the origin of
       the raw materials; whereas, however, dispatch of those products from the United
       Kingdom may take place immediately, without prior inspection by the Commission;
 (23) Whereas it is necessary to lay down appropriate guarantees for the dispatch from the
       United Kingdom of certain products obtained from bovine animals which were not
       slaughtered in the United Kingdom;
 (24) Whereas a reliable system of controls throughout the Community is a pre-condition for
      the smooth functioning of the beef market; whereas it is clear from the investigations by
      the Unit on Coordination of Fraud Prevention (UCLAF) and the Food and Veterinary
      OHice of the Commission that there are deficiencies in official controls on production
      of beef in the United Kingdom for dispatch to other Member States and third countries;
      whereas it is, therefore, necessary to reinforce the system of veterinary checks in order
      to prevent fraud;
(25) Whereas reinforced checks should apply to all commercial consignments of fresh meat
      of bovine animals moving into, through or from the territory of the United Kingdom;
      whereas it is appropriate to require that all such consignments be sealed and unsealed
      by the competent authority and accompanied by veterinary certificates and, in the case
      of intra-Community trade, to require an official notification of the dispatch of a
      consignment by means of the ANIMO system as referred to in Commission Decision
      91/398/EEC of 19 July 1991 on a computerised network linking veterinary authorities
      (ANIMO)" or by fax;
(26) Whereas the veterinary supervision of the processing of meat derived from bovine
      animals slaughtered elsewhere than in the United Kingdom should also be reinforced;
(27) Whereas the United Kingdom put forward a first proposal for an Export Certified Herds
      Scheme to the Commission on 25 February 1997; whereas the Scientific Veterinary
13
        OJ No L 221, 9.8.1991, p. 30.
 ---pagebreak---       Committee concluded at its meeting of II June 1997 that that proposal was not
      adequate; whereas the United Kingdom put forward a modified proposal dated 1 July
       1997; whereas the Scientific Veterinary Committee issued an opinion on that revised
      proposal on 17 September 1997 stating that the major obstacle to approving the scheme
      for the entire territory of the United Kingdom was the lack of a comprehensive
      computerised movement and tracing system and associated database for live cattle in
      Great Britain but that an adequate system did appear to exist in Northern Ireland;
      whereas the Committee concluded furthermore that small modifications could be made
      to minor aspects of the scheme at the request of the competent Commission
     departments in order to comply with certification or control requirements; whereas the
      Food and Veterinary Office conducted a feasibility inspection in Northern Ireland from
      3 to 7 November 1997; whereas the United Kingdom has agreed to further
     improvements in line with the recommendations made following that inspection;
     whereas, therefore, a partial lifting of the prohâwtion <m the dispatch of products from
     bovine animals slaughtered in Northern Ireland is appropriate;
{28) Whereas inspections carried out by the Commission services have shown that the
     system of veterinary checks m Northern Ireland is more effective; whereas, therefore, a
     stcp4>y-s1ep approach is -appropriate, starting; with the ïiftiag of the prohibrtfons on the
     dispatch of products from bovine animals slaughtered, cut, processed ^tnd stored in
     estaMisbments exclusively used for products destined for dispatch to oilier Member
     States and third countries, located in Northern Ireland; whereas subsequent steps will
     include the lifting of the prohibition on the processing of oligible meat from Northern
     Ireland in Great Britain, under conditions which wiîl be laid down at a later stage;
     wliereas the Commission will immediately start investigating, with the authorities of
     the United Kingdom, by what means and under what conditions those restrictions may
     be farther relaxed;
(29) Whereas in order to prevent fraud meat derived from bovine animals slaughtered in the
     United Kingdom should bear, in addition to the health mark provided for in Article
     3(l)(A)(e) of Council Directive 64/433/JvlvC of 26 June 1964 on health conditions for
 ---pagebreak---       (he production and marketing of fresh meat , as last amended by Directive 95/23/EC15,
      a distinct mark which cannot be confused with the Community health mark;
 (30) Whereas most of the provisions of Decision 94/474/EC are no longer in conformity
      with the opinion of the Scientific Veterinary Committee of 17 September 1997 and
      should therefore be deleted;
(31) Whereas Decision 96/239/1 {C required the United Kingdom to provide reports on the
      BSE situation every two weeks; whereas that period has been found to be too short and
      should be extended to one month;
(32) Whereas the Commission should continue to carry out Community inspections in the
      United Kingdom to verify the application of the measures provided for in this Decision;
(33) Whereas the foregoing entails a fundamental reworking of Decision 96/239/EC;
      whereas, in the interests of clarity, that Decision should be repealed;
(34) Whereas this Decision will be reviewed in the light of new scientific information;
(35) Whereas the Standing Veterinary Committee has not given a favourable opinion,
14
       OJ 121,29.7.1964, p. 2012/64
'•     OJ L 2 4 3 , 11.10.1995, p. 7.
                                                 10
 ---pagebreak---  HAS AIXXPTED THIS DECISION:
                                          (TIAI'TKKI
     Live bovine animals, bovine embryos, mcat-and-bonc meal and related products
                                            Article 1
 Pending an overall examination of the situation, and notwithstanding Community provisions
 adopted to protect against USE, the United Kingdom shall ensure that the following are not
 dispatched from its territory to other Member States or to third countries:
        (a)     live bovine animals and bovine embryos;
        (b)    meat meal, bone meal, and meat-and-bone meal of mammalian origin;
        (e)    animal feed and fertilizers containing material referred to in (b).
                                            Aâ3cje_2
By way of derogation from Article 1, food destined for domestic carnivores containing
material referred to in Article I (b) may be dispatched to other Member Slates or to third
countries provided that those materials did not originate from the United Kingdom and that
the conditions laid down in Articles 9 and 10 are complied with.
                                               li
 ---pagebreak---                                           CHAPTER II
        Materials derived from bovine animals slaughtered in the United Kingdom
                                             Article 3
Pending an overall examination of the situation, and notwithstanding Community provisions
adopted to protect against BSE, the United Kingdom shall ensure that the following are not
dispatched from its territory to other Member States or to third countries, when derived from
bovine animals slaughtered in the United Kingdom:
        (a)     meal;
       (b)     products which arc liable to enter the human food or animal feed chains;
       (e)     materials which are destined for use in cosmetics or medical or pharmaceutical
               products.
                                            Article 4
I.     By way of derogation from Article 3, the United Kingdom may authorize the
production and the dispatch from its territory to other Member States or to third countries of:
       (a)   amino acids, peptides and tallow, which have been produced in establishments
       under official veterinary supervision which have been shown to be operating in
       accordance with the conditions set out in Annex I;
       (b)     tallow products and products derived from tallow by saponification,
       transesterification or hydrolysis, where these are manufactured from tallow produced
       in accordance with this Article.
                                               12
 ---pagebreak---  2.      The United Kingdom shall ensure that the products referred to in paragraph 1 are
 labelled or otherwise identified to show the establishment of production and to indicate that
 they are suitable for use in human food, animal feed, cosmetics or medical or pharmaceutical
 products.
3.       I he United Kingdom shall ensure that products referred to in paragraph 1 (a) which
are dispatched to other Member States in accordance with this Article are accompanied by a
health certificate issued by an official veterinarian stating that they conform to the conditions
laid down in this Decision and attesting to the frequency of official controls carried out.
4.       Before an establishment may commence or recommence the dispatch of products
pursuant to this Article, the United Kingdom shall forward to the Commission and the other
Member States the list of the establishments referred to in paragraph 1 (a), identifying for
each establishment the purpose for which it has been approved. It shall notify the
Commission and the other Member States immediately of any amendments to that list.
5.       Community inspections shall be carried out on the implementation of official controls
in respect of each of the products referred to in paragraph 1 before the dispatch of those
products may commence or recommence.
6.      The Commission, after having consulted the Member States in the framework of the
Standing Veterinary Committee, shall set the date on which establishments may commence or
recommence dispatch of the products referred to in paragraph 1 (a).
                                             Article 5
          he United Kingdom shall ensure that gelatin, di-calcium phosphate, collagen, tallow,
                tallow products and products derived from tallow by saponification,
                transesterilication or hydrolysis which are produced for technical use from raw
                materials derived from bovine animals slaughtered in the United Kingdom are
                                                 13
 ---pagebreak---                  labelled or otherwise identified to show the establishment of production and
                         their unsuilability for use in human food, animal feed, cosmetics or
                         medical or pharmaceutical products.
                                              Article 6
  1.     By way of derogation from Article 3, the United Kingdom may authorize the dispatch
 to other Member Slates or to third countries of the following products derived from bovine
 animals born and reared in Northern Ireland which have been slaughtered in Northern Ireland
 in slaughterhouses exclusively used for that purpose, in accordance with the conditions laid
 down in this Article, Article 7, Articles 9 to 12 and Annex II:
                k
        (a)      fresh meat' as defined by Directive 64/433/EEC;
        (b)     'minced meal1 and 'meat preparations' as defined by Council Directive
                94/65/1 •C"';
        (c)     'meat products' as defined by Council Directive 77/99/EEC'7;
2.      The fresh meat referred to in paragraph 1 (a) shall be deboned and all adherent tissues,
including obvious nervous and lymphatic tissues shall be removed in cutting plants in
Northern Ireland, exclusively used for eligible products. Cold storage shall take place in
Northern Ireland in chambers exclusively used for eligible products. Cutting, storage and
transport shall be carried out in accordance with the conditions laid down in this Article,
Article 7, Articles 9 to 12 and Annex II.
3.      The fresh meal referred to in paragraph 1 (a) may be used for the production of
products referred to in paragraph 1 (b) and (c) in establishments in Northern Ireland
16
        OJ No L 368, 31.12.1994, p.10.
17
        OJ No L 26, 31.1.1977, p.85.
                                                 14
 ---pagebreak---  exclusively used for eligible products, in accordance with the conditions laid down in this
 Article, in Article 7, Articles 9 to 12 and Annex II.
 4.      l'or the purposes of this Article, eligible products means products referred to in
 paragraph 1 and products derived from bovine animals not slaughtered in the United
 Kingdom which comply with the conditions laid down in Article 9 to 13.
 5.      The Commission, after having carried out Community inspections and after having
 informed the Member States, shall set the date on which dispatch of the products referred to
 in paragraph 1 may commence.
6.       The Commission shall review the provisions of this Article at least every three
months and shall take appropriate measures in accordance with the procedure laid down in
Article 18 of Directive 89/662/EEC.
                                              Article 7
 1.     The meat and products referred to in Article 6(1) shall be marked or labelled with an
additional distinct mark which cannot be confused with the Community health mark.
2.       Meat and products as referred to in Article 6(1) which are destined for placing on the
market in the I Jnited Kingdom shall not bear the additional mark referred to in paragraph 1 of
this Arlicle. Where such a mark is present, it shall be cancelled or removed from the meal or
cancelled from the label at the time that meat or those products leave the establishment. The
Community health mark shall not be removed except where that is unavoidable in the cutting
process.
3.      The United Kingdom shall forward to the Commission and the other Member States
the model of the additional mark referred to in paragraph 1 before dispatch commences.
 ---pagebreak---                                         CHAPTER HI
    Materials derived from bovine animals not slaughtered in the United Kingdom
                                           Article 8
The United Kingdom shall ensure that the provisions of Articles 9 to 13 are complied with
when the following products derived from bovine animals not slaughtered in the United
Kingdom are dispatched from its territory to other Member Stales or to third countries:
       (a)     'fresh meat' as defined by Directive 64/433/EEC;
      (b)     'minced meat' and 'meat preparations' as defined by Council Directive
              94/65/1 vC;
      (c)     'meat products" and 'other products of animal origin' as defined by Council
             Directive 77/99/EEC;
      (d)food which is destined for domestic carnivores;
      (e)    gelatin and di-calcium phosphate, tallow, tallow products, and products
             derived from tallow by saponification, transesterification or hydrolysis, amino
             acids, peptides and collagen which are liable to enter the human food or animal
             feed chains, or are destined for use in cosmetics or medical or pharmaceutical
             products.
                                              16
 ---pagebreak---                                               Article 9
 I.       The products referred to in Article 8 shall come from and, as appropriate, have passed
 through, establishments in the United Kingdom:
          (a)     which have been approved by the competent authority;
          (b)     which are under official veterinary supervision or, in the case of products
          derived from tallow by saponification, Iranscslerifixation or hydrolysis, under
         the supervision of the competent authority;
         (e)    which have put in place a system of tracing of the raw material which will
         guarantee the origin of the material throughout the whole production chain;
         (d)    which have put in place a registration system of amounts of incoming and
         outgoing materials to allow for cross-checking consignments entering or leaving;
         (e)    in which the products are unloaded, processed, stored, handled, loaded and
         transported separately from, or at different times from, products which do not comply
         with the conditions laid down in this Article and Articles 10, 11 and 12.
2.       The United Kingdom shall forward to the Commission and the other Member States
the list of establishments which meet the conditions referred to in paragraph 1, identifying for
each establishment the purpose for which it has been approved. It shall notify the
Commission and the Member States immediately of any amendments to that list.
                                                 17
 ---pagebreak---                                             Article K>
 1.      Products referred to in Article 8 (a) to (d) shall come from and, as appropriate, have
 passed through establishments in the United Kingdom:
        (a)      in which all unloading, processing, storage or other handling and loading of
        products takes place under official supervision;
        (b)     in which the products are stored in cold stores in chambers which are not used
                at the same time for storing any bovine products which do not comply with the
                conditions laid down in this Article, in Articles 9, 11, 12 and 13 and are kept
        locked under the seal of the competent authority when the latter is not present;
        (c)     in which the products, with the exception of the products referred to in Article
                8 (d), are marked or labelled with an additional distinct mark which cannot be
               confused with the Community health mark;
       (d)     in which the products eligible for dispatch from the United Kingdom under
               this Article and Articles 9, 11, 12 and 13, but destined for placing on the
               market in the United Kingdom do not bear the additional mark referred to in
               point (c). Where such a mark is present, it shall be cancelled or removed from
               the meat or cancelled from the label at the time that meat or those products
               leave the establishment.
The United Kingdom shall forward to the Commission and the other Member States the
model of the additional mark.
                                               18
 ---pagebreak--- 2.        lor the purposes of the health marking and application of additional marks provided
 for in Community legislation, the competent authority shall keep and maintain under its
 responsibility:
       (a)       the instruments intended for meat health marking and application of additional
       marks, which may be handed over to auxiliaries only at time of marking and for the
       length of time required for that purpose;
       (b)       any labels bearing a health mark or an additional mark. Those labels shall be
       serially numbered and the requisite quantity shall may be given to auxiliaries at the time
       when they are to be used.
3.       The products referred to in paragraph 1 shall be transported in means of transport that
are sealed by the competent authority.
When those products are dispatched to other Member States, they shall be accompanied by a
health certificate issued by an official veterinarian staling that the conditions referred to in
this Article and Articles 9, II, 12 and 13 are met, identifying all establishments where they
were obtained, processed, handled or stored and identifying all labels and their serial numbers
in the consignment.
Meat shall be accompanied by the health certificate referred to in Annex IV to Directive
64/43 3/EEC identifying in the "Identification of Meat" section of the certificate all labels
and their serial numbers in the consignment.
The following words shall be added to all certificates:
         'produced in accordance with Commission Decision [98/../I.ÏC]'
4.      The United Kingdom shall inform the competent authority of the place of destination
of each consignment by means of the ANIMO system or by fax.
                                                 19
 ---pagebreak---                                               Article
  Without prejudice to Article 7 (2) and Article 10(1) (d), where products referred to in Article
 8 (a) come from and, as appropriate, have passed through establishments in the United
 Kingdom, (he health marks shall not be removed except where that is unavoidable in the
 cutting process.
                                             Article 12
 The products referred to in Article 8 (e) which are dispatched to other Member States shall be
 labelled in order to identify the establishment of production and to indicate that they have
 been produced in accordance with this Decision and, as appropriate, that they are suitable for
 use in human food, animal Iced, cosmetics or medical or pharmaceutical products.
                                             Article 13
 1.      A Member State which dispatches meat as referred to in Article 8 (a) from an
establishment or Community approved border inspection post in its territory through the
territory of the United Kingdom or to an establishment approved in accordance with Article 9
shall ensure that the meat is accompanied by a veterinary certificate issued by an official
veterinarian or the certificate issued by the competent authority of the border inspection post.
The originals of all certificates shall accompany the consignment to the establishment of its
destination.
2.       The meat as referred to in Article 8 (a) shall be transported in an officially sealed
vehicle.
                                                20
 ---pagebreak--- The seal may be broken only for official inspection purposes.
3.      A Member Stale which dispatches products referred to in Article 8 (e) or any raw
materials for use in the production of those products to an establishment approved in
accordance with Article 9 shall ensure that they are labelled or otherwise identified to show
the establishment and Member State in which they were produced.
                                             21
 ---pagebreak---                                        UIAI'TKK IV
                                      Final provisions
                                          Article 14
The Commission shall carry out Community inspections on-the-spot in the United Kingdom
to verify the application of the provisions of this Decision, in particular in relation to the
 implementation of official controls.
                                         Artklc 15
The United Kingdom shall send the Commission every month a report on the application of
the protective measures taken against BSE, in accordance with national and Community
provisions.
                                         Article 16
This Decision shall be reviewed regularly in the light of new scientific information. This
Decision shall be amended, where appropriate, after consultation of the appropriate
Scientific Committee, in accordance with the procedure laid down in Article 18 of Directive
89/662/EEC.
                                         Article 17
Member States shall adopt the necessary measures to comply with this Decision. They shall
immediately inform the Commission thereof.
                                             7.2
 ---pagebreak---                                             Article 18
Decision 94/474/EC is hereby amended as follows:
       (I)      Article 1 shall be deleted.
       (2)     In Article 3, paragraphs I and 2 shall be deleted.
       (3)     Article 4 shall be deleted.
                                            Article 19
Decision 96/239/EC is hereby repealed.
                                            Article 20
This Decision is addressed to the Member States.
Done at Brussels,
                                                             For the Council
                                               23
 ---pagebreak---                                              ANNEX I
                                             Chapter 1
 1.     The following products may be exported from the United Kingdom in application of the
        provisions of Articles 4 to 7:
    (a) amino acids and peptides produced from hides and skins by a process which involves
        exposure of the material to a pH of 1 to 2, followed by a pH of >11, followed by heat
        treatment at 140°C for 30 minutes at 3 bar;
    (b) tallow and tallow products produced from material from animals lit for human
        consumption which has been subjected to one of the processes described in Chapter 2;
    (c) products derived from tallow by one of the processes described in Chapter 3.
2.      Products referred to in point I must be filtered after production.
3.      Bovine animals which are showing signs of BSE and animals over 30 months of age
        may not be used as source materials (as provided for by Commission Regulation (EC)
        No 716/96) for production of the products referred to in point 1
4.      The following tissues may not be used for production of products referred to in point 1
        skull, vertebral column, brain, spinal cord, eye, tonsil, thymus, intestine or spleen.
        OJL 99, 20.4.1996, p. 14
                                                                  o2V
 ---pagebreak---                                            Chapter 2
 A.     Production standards for tallow produced in the United Kingdom from material
 derived from bovine animals slaughtered in the United Kingdom
  I.     fallow may be produced only in systems described in Chapters I to IV, VI and VII of
                                                7I
 the Annex
 the        to Commission Decision 92/562/EEC , in which the following minimum conditions
     Annex to
are achieved:
CHAPTER I       (Batch/Atmospheric/Natural Fat)
                150 mm particle size maximum
                Temperature           >100°C         >110°C       >120°C
                Time                  125 min        120 min      50min
CHAPTER II (Batch/Pressure/Natural Pat)
                50 mm particle size minimum
                Temperature             MX)°C          133°C
                 lime                 25 min         20 min
                Pressure (absolute)                  3 bar
CHAPTER III (Continuous/Atmospheric/Natural Pat)
                30 mm particle size maximum
                Temperature           >100°C        >110°C       >120°C
                Time                  95 min        55 min       13 min
CHAPTER IV (Continuous/Atmospheric/Added Fat and Continuous/Pressure/Added Fat)
A N D VI        30 mm particle size maximum
                Temperature           > 100°C       > 110°C      > 120°C        > 130°C
                rime                  16 min         13 min      8 min          3 min
CHAPTER VII(Continuou.s/Atnu>spheric/Defatted)
                20 mm particle size maximum
                Temperature           >80°C         >100°C
                Time                  120 min       60 min
21
        O J L 359,9.12.1992, p. 23.
                                                             25
 ---pagebreak---  The above temperature/lime requirements may run concurrently.
 2.      The United Kingdom may authorize plants only if they have been shown by
 methods laid down in Section B to be operating in accordance with the conditions set
 out in point 1.
 3.      Batch systems which achieve the parameters laid down in point 2 for continuous
 systems operating in accordance with Chapters III, IV, VI or VII may also be
 authorized.
 B.      Procedures for the validation of plants for the processing of animal waste of
 ruminant origin for the production of tallow in the United Kingdom, using
 methods described in the Annex to Decision 92/562/EEC
 1.      Temperature - continuous and batch systems
         Temperature monitoring devices must be situated regularly throughout the
equipment in order to record temperature at different stages in the process. Records
should be kept and calibrations completed at regular intervals.
2.       Pressure (Chapter II only)
         Pressure monitoring devices must be installed in order to record pressure at
stages in the process. Records must be kept and calibrations completed at regular
intervals.
3.      Particle size - all systems
                                            Jlo
 ---pagebreak---                                           Chapter 3
   Human food, animal feed, medical or pharmaceutical products, their starting
                           materials or intermediate products
 fallow derivatives may be used provided that they are produced by an appropriate,
validated and strictly certified method such as:
1. T ransesterilication 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 3 hours; or,
         in a continuous process: at not less than 140°C, 2 bars for not less than 8
         minutes, or equivalent.
           Cosmetic products, starting materials or intermediate products
 fallow derivatives may be used provided that the following methods have been used
and strictly certified by the producer:
1. 'I ransesterilication or I Iydrolysis at at least 200°C, 40 bars for 20 minutes
    (glycerol and fatty acids and esters); or,
2. Saponification with NaOH 12M (glycerol and soap):
         in a batch process: at 95°C for 3 hours; or,
         in a continuous process: at 140°C, 2 bars for 8 minutes or equivalent.
                                                 n
 ---pagebreak---                                          A1NNKX II
 1.       I )choncd fresh meat and products referred to in Article 6 ( I ) (b) and (c) from
thai meal derived from bovine animals slaughtered in Northern Ireland may be
dispatched from Northern Ireland in application of the provisions of Article 6 when
obtained from eligible animals which originate from eligible herds.
Eligible herds
2.       A herd is a group of animals forming a separate and distinct unit, that is a
group of animals which were managed, housed and kept separately from any other
group of animals and which were identilied with unique herd and animal
identification numbers.
3.       A herd is eligible when for at least 8 years, there has been no confirmed case
of BSK, nor a suspect ease for which the diagnosis of BSli has not been ruled out, in
any animal which was still in or had moved through or from the herd.
4.       As an exception to the provisions in point 2, a herd that has been in existence
for less than 8 years may be considered eligible, after a thorough epidemiological
investigation by the competent veterinary authority, on condition that:
       (a)       all animals born or moved into the newly established herd complied
       with the conditions set out in point 6 (a), (c), (d) and (e); and,
       (b)       the herd has complied with the conditions set out in point 3 during its
       entire existence.
5.       If a herd is newly established on a holding which experienced a confirmed
case of BSK in any animal which was still in or had moved through or from a herd on
that holding, the newly established herd can only be eligible after a thorough
epidemiological investigation by the competent veterinary authority, taking into
account compliance with each of the following conditions to the satisfaction of the
competent veterinary authority:
                                                 âr
 ---pagebreak---       (a) all animals of the affected herd have been removed or killed;
      (b) all feed has been removed and destroyed and all feed containers thoroughly
           cleansed;
      (c) all buildings have been emptied and thoroughly cleansed before the new
           animals were admitted;
      (d) all conditions set out in point 4 have been complied with.
 Eligible animals
6.        A bovine animal is eligible if it has been born and reared in Northern Ireland
and at the time of slaughter:
     (a) all records of its birth, identity and movements arc recorded on an official
           computerised tracing system;
     (b) it is more than 6 months but less than 30 months of age, determined by
           reference to an official computer record of its date of birth;
     (c) its dam has lived for at least 6 months after its birth;
     (d) its dam has not developed BSE and is not suspected of having contracted
           BSli;
     (e) the herd of birth of the animal and all herds through which it has ever moved
           are eligible.
7.       The official computerised tracing system referred to in point 6 (a) will be
accepted only where it has been in operation for sufficient lime to contain all the
information relating to the lifetime and movements of the animals needed to check
compliance with the requirements of this Decision, and only in respect of animals
born after the system came into operation. Historical data loaded into a computer for
any period before the system was operational will not be accepted for this purpose.
Controls
8.       If any animal presented for slaughter or any circumstance surrounding its
slaughter does not meet all of the requirements of this Decision, the animal must be
                                                  J9
 ---pagebreak---   automatically rejected. If that information becomes available after slaughter, the
 competent authority must immediately cease issuing certificates, and cancel issued
 certificates. If dispatch has already taken place, the competent authority must notify
 the competent authority of the place ol destination. The competent authority of the
 place of destination must take the appropriate measures.
 (
   ).      Slaughter of eligible animals must take place in slaughterhouses exclusively
 used for that purpose. Cutting, deboning and processing must take place in
 establishments exclusively used for products which are eligible for dispatch to other
 Member Slates or third countries. Cold storage must lake place in chambers,
 exclusively used for products which are eligible for dispatch to other Member States
 or third countries. All establishments through which the products pass before such
 dispatch must be situated in Northern Ireland.
 10.      The competent authority must ensure that procedures used in the cutting plants
ensure thai the following lymph nodes have been removed:
        Popliteal, ischiatic, superficial inguinal, deep inguinal, medial and lateral iliac,
        renal prefemoral, lumbar, costocervical, sternal, prescapular, axilliary and
       caudal deep cervical.
 11.      Meat must be traceable back to the herd of the eligible animal by means of the
computerised tracing system until the time of slaughter. After slaughter, labels must
be capable of tracing fresh meat and products referred to in Article 6 ( 1 ) (b) and (c)
back to the herd to enable the consignment concerned to be recalled.
12.       All approved eligible carcasses must have individual numbers correlated with
the ear tag number.
13.       The I Inited Kingdom must have detailed protocols in place covering:
      (a) tracing and controls prior to slaughter;
      (b) controls during slaughter;
      (c) all labelling and certification requirements after slaughter to the point of sale.
                                                    io
 ---pagebreak---  14.     The competent authority must set up a system for recording checks on
 compliance so that control can be demonstrated.
The establishment
 15.     To obtain approval, the establishment must, in addition to all other
requirements of this Decision, devise and implement a system whereby the eligible
meat and/or eligible product is identifiable and all meat or products can be traced back
to its herds of origin. The system must facilitate lull traceability oflhe meal or
products at all stages and records must be retained for at least two years. Details of the
system to be employed must be given, in writing, by the management oflhe
establishment to the competent authority.
 16.     The competent authority must assess, approve and monitor the system
provided by the establishment in order to ensure that it provides full segregation and
traceability both backwards and forwards.
                                                3i
 ---pagebreak---  ---pagebreak---                                                                   ISSN 0254-1475
                                                            COM(98) 161 final
                                              DOCUMENTS
EN                                                            03 05 02     15
                                    Catalogue number : CB-CO-98-153-EN-C
                                                             ISBN 92-78-31965-1
Office foi Official Publications of the European Communities
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