Proposal for a European Parliament and Council Regulation laying down rules for the prevention and control of certain transmissible spongiform encephalopathies
Date: 1998-11-18
Institutions: European Commission
Subjects: animal disease, consumer protection, disease prevention, epidemiology, health legislation, veterinary legislation

C  45/2

EN

Official  Journal  of  the  European  Communities

19.2.1999

II

(Preparatory  Acts)

COMMISSION

Proposal  for  a  European  Parliament  and  Council  Regulation  laying  down  rules  for  the
prevention  and  control  of  certain  transmissible  spongiform  encephalopathies

(1999/C  45/02)

(Text  with  EEA  relevance)

COM(1998)  623  final  -  98/0323(COD)

(Submitted  by  the  Commission  on  7  January  1999)

THE  EUROPEAN  PARLIAMENT  AND  THE  COUNCIL
OF  THE  EUROPEAN  UNION,

human  and  animal  health  by  certain  TSEs,  to  adopt
specific  rules  in  the  form  of  a  Regulation  for  their
prevention  and  control;

Having  regard  to  the  Treaty  establishing  the  European
Community,  and  in  particular  Article  100a(cid:216)(˛)  thereof,

Having  regard  to  the  proposal  from  the  Commission,

Having  regard  to  the  opinion  of  the  Economic  and
Social  Committee,

Acting  in  accordance  with  the  procedure  laid  down  in
Article  189b  of  the  Treaty,

(1)(cid:217)Whereas  several  distinct  transmissible  spongiform
encephalopathies  (TSEs)  have  been  recognised  for
many  years  to  occur  separately  in  humans  and
spongiform  encepha(cid:220)
animals;  whereas  bovine 
lopathy 
in  bovine
animals 
following  years  was
in 
recognised  to  occur  in  other  species  of  animals;
whereas  a  new  variant  of  Creutzfeldt(cid:220)Jakob  Disease
(nv(cid:220)CJD)  was  described  in  1996;  whereas  evidence
is  accumulating  that  the  agent  causing  BSE 
is
identical  to  that  causing  nv(cid:220)CJD.

(BSE)  was 
in  1986  and 

first  recognised 

from 

(2)(cid:217)Whereas  since  1990  the  Community  has  adopted  a
series  of  measures  to  protect  human  and  animal
those
health 
measures  have  been  based  on 
safeguard
provisions  of  Council  Directives  on  veterinary
control  measures;  whereas  it  is  appropriate,  in  view
to
of 

the  risk  of  BSE;  whereas 

the  magnitude  of 

posed 

risk 

the 

the 

(3)(cid:217)Whereas  this  regulation  directly  concerns  public
health  and  is  relevant  to  the  functioning  of  the
internal  market;  whereas  it  covers  products  which
are  included  in  Annex  II  to  the  Treaty  as  well  as
products  which  are  not;  whereas,  therefore,  it  is
appropriate  to  choose  Article  100a  of  the  Treaty  as
the  legal  basis;

(4)(cid:217)Whereas  the  Commission  has  obtained  scientific
opinions,  in  particular  from  the  Scientific  Steering
Committee  and 
the  Scientific  Committee  on
Veterinary  Measures  related  to  Public  Health,  on
several  aspects  of  TSEs;  whereas  those  opinions
include  advice  on  measures  to  reduce  the  potential
risk 
from
exposure  to  infected  animal  products;

for  humans  and  animals 

resulting 

(5)(cid:217)Whereas  the  rules  should  apply  to  the  production
and  placing  on  the  market  of  live  animals  and
products  of  animal  origin;  whereas,  however,  they
should  not  apply 
to  cosmetic,  or  medicinal
products,  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  Regulation  are  kept  separate  from  those
covered  by  it  unless  they  meet  at  least  the  same
health  standards  as  the  latter;

(˛)(cid:217)At  the  moment  at  which  the  Amsterdam  Treaty  comes  into

force,  please  read  Article  152.

(6)(cid:217)Whereas  provision  should  be  made  for  safeguard
measures  to  be  taken  by  the  Commission  in  cases
where  a  risk  from  a  TSE  has  not  been  adequately

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C  45/3

addressed  by  the  competent  authority  of  a  Member
State  or  third  country;

(7)(cid:217)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;

(8)(cid:217)Whereas  Member  States  should  institute  education
programmes  for  those  involved  in  the  prevention
and  control  of  TSEs,  as  well  as  for  veterinarians,
farmers  and  workers  involved  in  the  transportation,
marketing  and  slaughter  of  farm  animals;

(9)(cid:217)Whereas  Member  States  should  carry  out  an  annual
programme  of  monitoring  for  BSE  and  scrapie  and
the  other
should 
Member  States  of  the  results  of  the  programme
each  year,  and  of  the  emergence  of  any  other  TSE;

the  Commission  and 

inform 

(10)(cid:217)Whereas 

tissues 

certain 

should  be
ruminant 
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;

(11)(cid:217)Whereas  measures  should  be  taken  to  prevent  the
transmission  of  TSEs  to  humans  or  animals  by
prohibiting  the  feeding  of  certain  categories  of
animal  protein  to  certain  categories  of  animals,  and
by  prohibiting  the  use  of  certain  ruminant  materials
in  human  food;  whereas  those  prohibitions  should
be  proportionate  to  the  risks  involved;

(12)(cid:217)Whereas  the  suspected  presence  of  any  TSE  in  any
the  competent

should  be  notified 

animal 

to 

the 

including  placing 

authority,  which  should  immediately  take  all  appro(cid:220)
priate  measures, 
suspect
animal  under  movement  restrictions  pending  the
outcome  of  an  assessment  or 
its  killing  under
the  competent
official 
authority  cannot  exclude  the  possibility  of  a  TSE,  it
should  have  the  appropriate  investigations  carried
out  and  should  retain  the  carcase  under  official
supervision  until  a  diagnosis  has  been  made;

supervision;  whereas 

if 

including 

the  necessary  measures 

(13)(cid:217)Whereas  in  the  event  of  official  confirmation  of  the
presence  of  a  TSE,  the  competent  authority  should
take  all 
the
destruction  of  the  carcase,  carrying  out  an  enquiry
to  identify  any  other  animals  at  risk,  and  placing
animals  and  products  of  animal  origin  identified  as
restrictions;
risk  under  movement 
carrying  a 
whereas  owners 
fully,
without  delay,  for  the  loss  of  animals  and  products
of  animal  origin  destroyed  pursuant  to  this  Regu(cid:220)
lation;

should  be  compensated 

(14)(cid:217)Whereas  Member 

should 

up
States 
contingency  plans  for  the  national  measures  to  be
implemented  in  the  event  of  an  outbreak  of  BSE;
whereas  those  plans  should  be  approved  by  the
Commission;  whereas  provision  should  be  made  for
extending  this  provision  to  TSEs  other  than  BSE;

draw 

and 

embryos;  whereas 

(15)(cid:217)Whereas  provisions  should  be  laid  down  covering
the  placing  on  the  market  of  certain  live  animals,
existing
semen,  ova 
Community  rules  on  the  identification  and  regis(cid:220)
tration  of  bovine  animals  provide  for  a  system
enabling  the  animals  to  be  traced  back  to  the  dam
and  herd  of  origin  in  accordance  with  the  inter(cid:220)
national  standards;  whereas  equivalent  guarantees
should  be  provided  for  bovine  animals  imported
from  third  countries;  whereas  the  animals  and
products  of  animal  origin  covered  by 
these
intra(cid:220)Community  trade  or
in 
provisions,  moving 
imported  from  third  countries,  should  be  accom(cid:220)
panied  by  the  certificates  required  by  Community
legislation, 
in
accordance  with  this  Regulation;  whereas  those
existing  rules  may  be  extended  to  cover  other  live
animals,  semen,  ova  and  embryos;

supplemented 

appropriate 

as 

(16)(cid:217)Whereas  the  placing  on  the  market  of  products  of
animal  origin  derived  from  bovine  animals  in  high
risk  areas  should  be  prohibited;  whereas,  however,
that  prohibition 
should  not  apply  of  certain
animal  origin  produced  under
products  of 
controlled  conditions  from  animals  which  can  be
demonstrated  not  to  pose  a  high  risk  of  infection
with  a  TSE;

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19.2.1999

(17)(cid:217)Whereas  it  is  necessary,  in  order  to  ensure  that  the
rules  concerning  the  prevention  and  control  of
TSEs  are  observed,  for  samples  to  be  taken  for
laboratory  testing;  whereas  in  order  to  guarantee
uniform  testing  procedures  and  results,  national  and
Community  Reference  Laboratories 
should  be
established;

the 

include 

implementation  of 

in  the  Member  States 

(18)(cid:217)Whereas  Community  inspections  should  be  carried
in  order  to  ensure
out 
uniform 
requirements
concerning  the  prevention  and  control  of  TSEs  and
the  application  of  audit
should  also 
procedures;  whereas  in  order  to  ensure  that  guar(cid:220)
antees  concerning  the  prevention  and  control  of
TSEs  equivalent  to  those  applied  by  the  Community
are  provided  by  third  countries  on  import  of  live
animals  and  products  of  animal  origin,  Community
on  the  spot  inspections  and  audits  must  be  carried
out  in  order  to  verify  that  the  import  conditions  are
met  by  exporting  third  countries;

(19)(cid:217)Whereas  trade  measures  for  TSEs  should  be  based
on 
international  standards,  guidelines  or  recom(cid:220)
mendations,  where  they  exist;  whereas,  however,
scientifically  justified  measures  resulting  in  a  higher
level  of  sanitary  protection  may  be  adopted 
if
measures  based  on 
international
the 
standards,  guidelines  or  recommendations  would
not  achieve 
sanitary
protection;

the  appropriate 

level  of 

relevant 

certain  measures 

task  of  adopting 

(20)(cid:217)Whereas  the  Commission  should  be  entrusted  with
for
the 
implementing  this  Regulation;  whereas  to  that  end,
procedures  should  be  laid  down  establishing  close
and  effective  cooperation  between  the  Commission
and 
the  Standing
Veterinary  Committee  and  the  Standing  Committee
for  Feedingstuffs;

the  Member  States  within 

(21)(cid:217)Whereas  this  Regulation  should  be  reviewed  in  the

light  of  new  scientific  information,

HAVE  ADOPTED  THIS  REGULATION:

CHAPTER  I

GENERAL  PROVISIONS

Article  1

Scope

1.(cid:218)(cid:217)This  Regulation  lays  down  rules  for  the  prevention,
transmissible
control 

eradication  of 

certain 

and 

spongiform  encephalopathies  (TSEs).  It  shall  apply  to  the
production  and  placing  on  the  market  of  live  animals
and  products  of  animal  origin.

2.(cid:218)(cid:217)This  Regulation  shall  not  apply  to:

(a)(cid:217)cosmetic  or  medicinal  products  or  medical  devices,
together  with  their  starting  materials  or  intermediate
products;

(b) products  which  are  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.

Article  2

Separation  of  products  of  animal  origin

In  order  to  avoid  cross(cid:220)contamination  or  substitution  of
the  products  of  animal  origin  referred  to  in  Article  1(1)
by  those  referred  to  in  Article  1(2),  they  shall  be  kept
separate  at  all  stages  unless  the  latter  are  produced  under
at 
in
least  the  same  conditions  of  health  protection 
respect  of  TSEs.

Rules  for  the  implementation  of  this  Article  shall  be
adopted  in  accordance  with  the  procedure  laid  down  in
Article  22.

Article  3

Definitions

For  the  purposes  of  this  Regulation,  the  following  defi(cid:220)
nitions  and  those  laid  down  in  Annex  I  shall  apply:

1. transmissible  spongiform  encephalopathies  or  TSEs:  all
in
TSEs  with  the  exception  of  those  occurring 
humans;

2. placing  on  the  market:  any  operation  the  purpose  of
which  is  to  supply  live  animals,  semen,  embryos,  ova
or  products  of  animal  origin  covered  by  this  Regu(cid:220)
lation  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  between  a  Member  State  and  a  third
country  or  vice  versa;

3. products  of  animal  origin:  any  products  derived  from
or  containing  a  product  derived  from  any  animal;

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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  1(2)(a)  and
(b)  are  produced;

the  appropriate
competent  authority  has  not 
measures,  the  Commission  shall,  acting  on 
its  own
initiative  or  at  the  request  of  a  Member  State,  adopt  the
appropriate  safeguard  measures  without  delay.

taken 

5. competent  authority: 

the  central  authority  of  a
Member  State  competent  to  ensure  compliance  with
the  requirements  of  this  Regulation  or  any  authority
to  which  that  central  authority  has  delegated  that
competence;  it  shall  also  include,  where  appropriate,
the  corresponding  authority  of  a  third  country;

6. categories: 
Chapter  B;

the  categories  set  out 

in  Annex  II,

7. specified  risk  material:  the  tissues  specified  in  Annex
IV;  unless  otherwise  specified,  it  does  not  include
products  containing  or  derived  from  those  tissues;

8. farmed  animal:  any  vertebrate  or  invertebrate  animal
which  is  kept,  fattened  or  bred  for  reproduction  or
the  production  of  meat,  milk,  eggs,  wool,  fur,
feathers,  skins,  or  any  other  product  of  animal
origin;

9. skull:  the  bones  of  the  head,  including  the  bones  of

the  lower  jaw;

10. animals  suspected  of  being  infected:  animals  which
show  clinical  signs  compatible  with  TSE  and  for
which  no  alternative  diagnosis  has  been  established,
or  animals  showing  post(cid:220)mortem  lesions  or  reactions
in  laboratory  tests  giving  rise  to  reasonable  suspicion
of  the  presence  of  a  TSE.  BSE  shall  be  suspected  in
bovine  animals  aged  over  20  months  and  scrapie  in
ovine  and  caprine  animals  aged  over  12  months
displaying  behavioural  or  neurological  signs  where
the  disease  cannot  be  ruled  out  either  on  the  basis  of
response  to  treatment  or  following  laboratory  exam(cid:220)
ination;

11. holding:  any  place  in  which  animals  covered  by  this
Regulation  are  held,  kept,  bred,  handled  or  shown
to  the  public;

12. sampling:  the  taking  of  samples,  ensuring  a  stat(cid:220)
istically  correct  representation,  from  animals  or  their
environment,  or  from  products  of  animal  origin,  for
the  purpose  of  establishing  a  disease  diagnosis,  for
health  surveillance,  or  for  the  monitoring  of  the
absence  of  microbiological 
certain
materials  in  products  of  animal  origin.

agents  or 

Article  4

Safeguard  measures

1.(cid:218)(cid:217)Where  the  risk  of  transmission  of  a  spongiform
encephalopathy  constitutes  a  hazard  to  the  life  or  health
in  the  Community  and  the
of  humans  or  animals 

Where  a  Member  State  has  requested  such  measures  the
Commission  shall  decide  on  that  request  within  ten
working  days  after  receipt  thereof.

2.(cid:218)(cid:217)Within  ten  working  days  after  the  adoption  of  the
safeguard  measures,  the  Commission  shall,  in  accordance
with  the  procedure  laid  down  in  Article  22,  confirm,
amend  or  repeal  the  measures.

CHAPTER  II

DETERMINATION  OF  BSE  STATUS

Article  5

Classification

1.(cid:218)(cid:217)Member  States  or  third  countries  shall  submit  an
application  to  the  Commission,  accompanied  by  the
information  laid  down  in  Annex  II,  Chapter  A,  for  their
BSE  status  to  be  determined.

2.(cid:218)(cid:217)The  Commission,  acting  in  accordance  with  the
procedure  laid  down  in  Article  23,  shall  take  a  decision
in  respect  of  each  application  to  place  the  applicant
Member  State  or  third  country,  or  region  thereof,  in  one
of  the  categories  set  out  in  Annex  II,  Chapter  B.

the 

submission  of 

the  application. 

The  Commission  shall  take  its  decision  within  six  months
after 
the
Commission  finds  that  the  application  does  not  include
all  the  information  laid  down  in  Annex  II,  Chapter  A,  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.

If 

3.(cid:218)(cid:217)Member  States  or  third  countries  which  have  not
submitted  an  application  in  accordance  with  paragraph  1
within  six  months  after  the  date  referred  to  in  the  second
paragraph  of  Article  26  shall  be  placed  in  a  category  by
the  Commission  on  the  basis  of  all  information  available
to  the  Commission.

4.(cid:218)(cid:217)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  Regulation
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.

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5.(cid:218)(cid:217)The  decisions  referred  to  in  paragraph  2  and  3  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  recommended  criteria(cid:216)(˛)  set  out  in
Annex  II,  Chapter  B.

2.(cid:218)(cid:217)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  22,  applied  under  the  conditions  laid  down  in
Annex  IV,  point  7,  and  the  results  of  that  test  were
negative.

CHAPTER  III

PREVENTION  OF  TSEs

Article  6

Education  programme

Member  States  shall  establish  education  programmes  for
staff  of  the  competent  authority  and  of  diagnostic  labo(cid:220)
ratories,  for  veterinarians,  farmers  and  workers  involved
in  transportation,  marketing  and  slaughter  of  farmed
animals,  animal  breeders  and  keepers  and  persons
handling  animals  in  order  to  enhance  the  efficacy  of  the
monitoring  system,  referred  to 
in  Article  7,  and  to
encourage  reporting  of  cases  of  neurological  disease  in
adult  animals  and,  as  appropriate,  laboratory  findings
relating  to  TSEs.

Article  7

Monitoring  system

1.(cid:218)(cid:217)Each  Member  State  shall  carry  out  an  annual
programme  of  monitoring  of  BSE  and  scrapie 
in
accordance  with  Annex  III,  Chapter  A.

2.(cid:218)(cid:217)Each  Member  State  shall  inform  the  Commission
and  the  other  Member  States,  within  the  Standing
Veterinary  Committee,  of  the  results  obtained  from  the
monitoring  programme  referred  to  in  paragraph  1,  and
of  the  emergence  of  TSEs  other  than  BSE  or  scrapie.

3.(cid:218)(cid:217)The  information  for  each  calendar  year  shall  be
presented  in  a  report  submitted  to  the  Commission  at  the
latest  by  31  March  of  the  following  year.  It  shall  cover  at
least  the  information  referred  to  in  Annex  III,  Chapter  B.

Article  8

Specified  risk  material

1.(cid:218)(cid:217)The  specified  risk  materials  shall  be  removed  and
disposed  of  in  accordance  with  Annex  IV.  They  shall  not
be  placed  on  the  market  for  human  food,  animal  feed  or
fertilisers.

(˛)(cid:217)The  Commission  undertakes  to  propose  during  the  legis(cid:220)
lative  process,  criteria  for  the  assessment  of  the  propagation
and  human  exposure  risk.

3.(cid:218)(cid:217)In  Member  States,  or  regions  thereof,  which  are
not  placed  in  Category  1,  the  following  slaughter  tech(cid:220)
niques  shall  not  be  used  on  bovine,  ovine  or  caprine
animals  whose  meat  is  destined  for  human  or  animal
consumption:

(a)(cid:217)stunning  or  killing  by  means  of  a  gas  injected  into

the  cranial  cavity;

(b) laceration  after  stunning  of  central  nervous  tissue  by
instrument

rod(cid:220)shaped 

means  of  an  elongated 
introduced  into  the  cranial  cavity.

4.(cid:218)(cid:217)Rules  for  the  implementation  of  this  Article  shall  be
adopted  in  accordance  with  the  procedure  laid  down  in
Article  22.

Article  9

Animal  feeding

1.(cid:218)(cid:217)The  feeding  to  ruminants  of  protein  derived  from
mammals  is  prohibited.

2.(cid:218)(cid:217)In  Member  States,  or  regions  thereof,  which  are
placed  in  Category  4,  the  following  are  prohibited:

(a)(cid:217)the  feeding  to  any  farmed  animal  of  protein  derived

from  mammals;  and,

(b) the  feeding  to  any  mammal  of  protein  derived  from

ruminants.

3.(cid:218)(cid:217)Paragraphs  1  and  2  shall  apply  without  prejudice  to
the  provisions  of  Annex  V.

for 

the 

implementation  of 

4.(cid:218)(cid:217)Rules 
this  Article,
including  rules  on  the  prevention  of  cross(cid:220)contamination
and  on  sampling  and  methods  of  analysis  to  check
compliance,  shall  be  adopted  in  accordance  with  the
procedure  laid  down  in  Article  22.

Article  10

Certain  products  of  animal  origin  derived  from  or
containing  ruminant  products

1.(cid:218)(cid:217)In  Member  States,  or  regions  thereof,  which  are
placed  in  Category  4,  the  use  of  ruminant  materials  for
the  production  of  the  products  of  animal  origin  referred
to  in  Annex  VI  shall  be  subject  to  the  conditions  laid
down  in  that  Annex.

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2.(cid:218)(cid:217)In  Member  States,  or  regions  thereof,  which  are
not  placed  in  Category  1,  the  use  of  ruminant  skull  and
vertebral  column  for  the  production  of  mechanically
separated  meat  is  prohibited.

for 

the 

implementation  of 

3.(cid:218)(cid:217)Rules 
this  Article,
including  rules  on  production  standards,  shall  be  adopted
in  accordance  with  the  procedure  laid  down  in  Article
22.

CHAPTER  IV

CONTROL  AND  ERADICATION  OF  TSEs

Article  11

Notification  of  suspected  presence  of  TSEs

Without  prejudice  to  Council  Directive  82/894/EEC(cid:216)(˛),
the  suspected  presence  of  any  TSE  in  any  animal  shall  be
notified  immediately  to  the  competent  authority  of  the
Member  States  concerned.

The  competent  authority  shall  without  delay  take  the
measures  laid  down  in  Article  12  of  this  Regulation,
together  with  any  other  necessary  measures.

Article  12

Measures  with  respect  to  suspect  animals

1.(cid:218)(cid:217)Any  animal  suspected  of  being  infected  by  a  TSE
shall 
either  be  placed  under  official  movement
restrictions  pending  the  outcome  of  an  assessment  by  the
competent  authority  or  killed  under  official  supervision.

2.(cid:218)(cid:217)Where  the  competent  authority  decides  that  the
possibility  of  infection  with  a  TSE  cannot  be  ruled  out,
the  suspect  animal  shall  be  killed  and  its  brain  and  such
other  tissues  as  the  competent  authority  may  determine
shall  be  removed  and  sent  to  an  officially  approved
laboratory,  the  national  reference  laboratory  provided
for 
the  Community  reference
laboratory  provided  for  in  Article  17(2),  for  testing  for
the  presence  of  a  TSE  using  the  methods  referred  to  in
Article  18.

in  Article  17(1)  or 

3.(cid:218)(cid:217)All  parts  of  the  body  of  the  suspect  animal,
including  the  hide  but  excluding  the  tissues  which  are
being  tested  in  accordance  with  paragraph  2,  shall  be
retained  under  official  supervision  until  a  negative
diagnosis  has  been  made,  or  until  it  has  been  completely
destroyed  in  accordance  with  Annex  IV,  point  4  or,  as
appropriate,  point  5.

Article  13

Measures  following  confirmation  of  the  presence  of  TSE

1.(cid:218)(cid:217)Where  the  presence  of  a  TSE  has  been  officially
confirmed, 
following  measures  shall  be  applied
without  delay:

the 

(a)(cid:217)all  parts  of 

the  body  of 

the  animal  shall  be
completely  destroyed,  in  accordance  with  Annex  IV,
point  4  or,  as  appropriate,  point  5;

(b) an  inquiry  shall  be  carried  out  to  identify  all  animals

at  risk  in  accordance  with  Annex  VII,  point  1.

2.(cid:218)(cid:217)Where  the  presence  of  a  TSE  has  been  officially
confirmed,  all  animals,  semen,  ova  and  embryos  referred
to  in  Annex  VII,  point  2,  that  have  been  identified  to  be
at  risk  by  the  inquiry  referred  to  in  paragraph  1(b)  shall
be  placed  under  movement  restriction  or  killed  and
completely  destroyed 
in  accordance  with  Annex  IV,
point  4  or,  as  appropriate,  point  5.

3.(cid:218)(cid:217)Pending  the  completion  of  the  measures  referred  to
in  paragraph  1(b)  and  paragraph  2,  the  holding  on  which
the  animal  was  present  when  the  presence  of  a  TSE  was
suspected  shall  be  placed  under  official  surveillance  and
all  movement  of  animals  susceptible  to  TSEs,  their
semen,  ova  and  embryos,  from  or  to  the  holding  shall  be
subject  to  authorisation  by  the  competent  authority,  with
a  view  to  ensuring  immediate  tracing  and  identification
of 
in
question.

their  semen,  ova  and  embryos 

the  animals, 

4.(cid:218)(cid:217)Owners  shall  be  compensated  without  delay  for  the
loss  of  the  animals  that  have  been  killed  in  accordance
with  Article  12(2)  and  paragraph  2  of  this  Article,  or  the
semen,  embryos  and  ova  that  have  been  destroyed  in
accordance  with  paragraphs  1  and  2  of  this  Article.  The
compensation  shall  not  be  less  than  100(cid:216)%  of  the  market
value.

5.(cid:218)(cid:217)The  provisions  of  paragraph  2  shall  be  amended  in
accordance  with  the  procedure  laid  down  in  Article  23.

6.(cid:218)(cid:217)Rules  for  the  implementation  of  this  Article  shall  be
adopted  in  accordance  with  the  procedure  laid  down  in
Article  22.

Article  14

Contingency  plan

to  be 

contingency  plan 

1.(cid:218)(cid:217)A 
the  national
the  event  of  an
measures 
occurrence  of  BSE  shall  be  drawn  up  by  each  Member
State  in  accordance  with  the  general  criteria  laid  down  in
Community  rules  on  the  control  of  animal  diseases.

specifying 
in 

implemented 

(˛)(cid:217)OJ  L  378,  31.12.1982,  p.  58.

This  plan  must  provide  for  access  to  the  personnel,
facilities,  equipment  and  all  other  appropriate  materials
necessary  for  the  rapid  and  efficient  eradication  of  BSE.

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2.(cid:218)(cid:217)The  contingency  plans  referred  to  in  paragraph  1
shall  be  submitted  to  the  Commisison  no  later  than  six
months  after 
the  second
paragraph  of  Article  26.

the  date  referred 

to 

in 

3.(cid:218)(cid:217)The  Commission  shall  approve  the  contingency
plans  in  accordance  with  the  procedure  laid  down  in
Article  22.

Article  16

Bovine,  ovine  or  caprine  meat  and  certain  products  of
animal  origin  thereof

1.(cid:218)(cid:217)The  following  products  of  animal  origin  containing
material  derived  from  bovine,  ovine  or  caprine  animals
shall  be  subject  to  the  rules  laid  down  in  paragraphs  2  to
6  of  this  Article  and  Annex  IX.

The  plans  may  subsequently  be  amended  or  supple(cid:220)
mented,  in  accordance  with  the  same  procedure.

(a)

fresh  meat  as  defined  by  Council  Directive
64/433/EEC(cid:216)(˛);

4.(cid:218)(cid:217)The  provisions  of  paragraphs  1,  2  and  3  may  be
extended  to  TSEs  other  than  BSE  in  accordance  with  the
procedure  laid  down  in  Article  23.

5.(cid:218)(cid:217)Rules  for  implementation  of  this  Article  shall  be
adopted  in  accordance  with  the  procedure  laid  down  in
Article  22.

CHAPTER  V

PLACING  ON  THE  MARKET

Article  15

Live  animals,  semen,  embryos  and  ova

1.(cid:218)(cid:217)The  placing  on  the  market  of  bovine,  ovine  or
caprine  animals  and  their  semen,  embryos  and  ova  shall
be  subject  to  the  conditions  laid  down  in  Annex  VIII,
Chapter  A.  The  animals  and  their  semen,  embryos  and
ova  shall  be  accompanied  by  the  appropriate  animal
health  certificates  as  required  by  Community  legislation,
subject  to  the  conditions 
in  Annex  VIII
Chapter  D.

laid  down 

2.(cid:218)(cid:217)The  animals  referred  to  in  Annex  VIII,  Chapter  B
imported  from  countries  or  regions  thereof  in  Categories
2,  3  and  4  shall  be  identified  by  a  permanent  identifi(cid:220)
cation  system  enabling  them  to  be  traced  back  to  the
dam  and  herd  of  origin.

3.(cid:218)(cid:217)Placing  on  the  market  of  first  generation  progeny,
semen,  ova  and  embryos  of  TSE  suspect  or  confirmed
animals  shall  be  subject  to  the  conditions  laid  down  in
Annex  VIII,  Chapter  C.

4.(cid:218)(cid:217)The  provisions  of  paragraphs  1,  2  and  3  may  be
extended  to  other  animals,  semen,  ova  or  embryos  in
accordance  with  the  procedure  laid  down  in  Article  23.

5.(cid:218)(cid:217)Rules  for  the  implementation  of  this  Article  shall  be
adopted  in  accordance  with  the  procedure  laid  down  in
Article  22.

(b) minced  meat  and  meat  preparations  as  defined  by

Council  Directive  94/65/EC(cid:216)(ˇ);

(c) meat  products  and  other  products  of  animal  origin
as  defined  by  Council  Directive  77/99/EEC(cid:216)(—);

(d) milk  products  as  defined  by  Council  Directive
92/46/EEC(cid:216)((cid:209))  which  are  destined 
for  human
consumption  and  contain  gelatin  or  rendered  animal
fat;

(e) milk  products  as  defined  by  Council  Directive
92/118/EEC(cid:216)((cid:210))  which  are  destined 
for  animal
consumption  and  contain  gelatin  or  rendered  animal
fat;

(f)

fishery  products  as  defined  by  Council  Directive
91/493/EEC(cid:216)((cid:211))  which  are  destined 
for  human
consumption  and  contain  gelatin  or  rendered  animal
fat;

(g) egg  products  as  defined  by  Council  Directive
89/437/EEC(cid:216)((cid:212))  which  are  destined 
for  human
consumption  and  contain  gelatin  or  rendered  animal
fat;

(h)

snails  or  frogs’  legs  as  referred  to  by  Directive
92/118/EEC  which  are  destined 
for  human
consumption  and  contain  gelatin  or  rendered  animal
fat;

(i)

rendered 
92/118/EEC;

fats 

as 

referred 

to 

by  Directive

(j)

gelatin  as  referred  to  by  Directive  92/118/EEC;

(k) petfood  as 
EEC;

referred 

to  by  Directive  92/118/

(l)

processed  animal  protein  as  referred  to  by  Directive
92/118/EEC;

(˛)(cid:217)OJ  121,  29.7.1964,  p.  2012/64.
(ˇ)(cid:217)OJ  L  368,  31.12.1994,  p.  10.
(—)(cid:217)OJ  L  26,  31.1.1977,  p.  85.
((cid:209))(cid:217)OJ  L  268,  14.9.1992,  p.  1.
((cid:210))(cid:217)OJ  L  62,  15.3.1993,  p.  49.
((cid:211))(cid:217)OJ  L  268,  24.9.1991,  p.  15.
((cid:212))(cid:217)OJ  L  212,  22.7.1989,  p.  87.

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(m)(cid:217)bones  and  bone  products  as  referred  to  by  Directive

92/118/EEC;

(n)

raw  material  for  the  manufacture  of  animal  feed(cid:220)
ingstuffs  as  referred  to  by  Directive  92/118/EEC.

2.(cid:218)(cid:217)Products  referred  to 
in  paragraph  1  containing
material  derived  from  bovine  animals  coming  from
countries  or  regions  thereof  in  Category  4  shall  not  be
placed  on  the  market.

3.(cid:218)(cid:217)The  prohibition  referred  to  in  paragraph  2  shall  not
apply  to  the  products  referred  to  in  Annex  IX,  Chapter
following
A.I  containing  material  derived 
bovine  animals:

from 

the 

(a)(cid:217)animals  born  after  the  date  from  which  the  ban  on
the  feeding  of  ruminants  with  protein  derived  from
mammals  has  been  effectively  enforced  which  are
eligible  under  a  Date(cid:220)based  Scheme,  or,  as  appro(cid:220)
priate,  an  equivalent  scheme,  as  laid  down  in  Annex
IX,  Chapter  A.II;  or

(b) animals  which  were  born,  raised  and  had  remained
in  herds  with  a  certified  history  of  freedom  from
BSE  and  are  eligible  under  a  Certified  Animal
Scheme,  or,  as  appropriate,  an  equivalent  scheme,  as
laid  down  in  Annex  IX,  Chapter  A.III.

4.(cid:218)(cid:217)For  the  purpose  of  import  into  the  Community,
products  referred  to  in  paragraph  1  shall  be  accompanied
by  the  appropriate  certificate,  as  required  by  Community
the
legislation, 
provisions  laid  down  in  Annex  IX,  Chapter  B.II.

accordance  with 

supplemented 

in 

Where  such  products  are  imported  from  third  countries
or  regions  thereof  in  Category  4,  or  regions  within  such
the
third  countries, 
conditions  laid  down  in  Annex  IX,  Chapter  B.I.

shall  also  comply  with 

they 

5.(cid:218)(cid:217)If  necessary,  the  provisions  of  paragraphs  1  to  4
may  be  extended  to  products  of  animal  origin  other  than
those  referred  to  in  paragraph  1  in  accordance  with  the
procedure  laid  down  in  Article  23.

6.(cid:218)(cid:217)Rules  for  the  implementation  of  this  Article  shall  be
adopted  in  accordance  with  the  procedure  laid  down  in
Article  22.

2.(cid:218)(cid:217)The  Community 
its
function  and  duties  shall  be  those  laid  down  in  Annex  X,
Chapter  B.

laboratory  and 

reference 

Article  18

Sampling  and  laboratory  methods

1.(cid:218)(cid:217)Sampling  and  laboratory  testing  for  the  presence  of
a  TSE  shall  be  carried  out  using  the  methods  and
protocols  laid  down  in  Annex  X,  Chapter  C.  In  the
absence  of  such  methods  and  protocols,  those  recom(cid:220)
mended  in  the  Manual  of  Standards  for  Diagnostic  Tests
and  Vaccines  of  the  International  Office  for  Epizootics
(IOE/OIE),  May  1998  edition  shall  apply.

2.(cid:218)(cid:217)Rules  for  the  implementation  of  paragraph  1  shall
be  adopted  in  accordance  with  the  procedure  laid  down
in  Article  22.

Article  19

Community  controls

inspections  and  audits  of  all 

1.(cid:218)(cid:217)The  Commission  shall, 
in  cooperation  with  the
competent  authorities  of  the  Member  States,  carry  out
on(cid:220)the(cid:220)spot 
levels  of
production  and  placing  on  the  market  of  animals  and
products  of  animal  origin  covered  by  this  Regulation  and
of  the  organisation  and  functioning  of  the  competent
authorities  in  the  Member  States  and  in  third  countries,
in  order  to  ensure  that  the  provisions  of  this  Regulation,
rules  adopted  pursuant 
safeguard
measures  are  applied  uniformly.

thereto  and  any 

2.(cid:218)(cid:217)Rules  for  the  implementation  of  paragraph  1  shall
be  adopted  in  accordance  with  the  procedure  laid  down
in  Article  22.

CHAPTER  VII

FINAL  PROVISIONS

Article  20

CHAPTER  VI

Amendments  to  Annexes  and  transitional  measures

REFERENCE  LABORATORIES,  SAMPLING,  TESTING
AND  CONTROLS

Article  17

Reference  laboratories

1.(cid:218)(cid:217)The  national  reference  laboratory  in  each  Member
State  and  their  functions  and  duties  shall  be  those  laid
down  in  Annex  X,  Chapter  A.

The  Commission  shall,  after  obtaining  the  opinion  of  the
appropriate  Scientific  Committee  on  any  matter  likely  to
have  an  effect  on  health:

(a)(cid:217)amend  or  supplement  the  Annexes  in  accordance

with  the  procedure  laid  down  in  Article  23;

(b) adopt  any  appropriate 

transitional  measures 
laid  down 

the  procedure 

in
in

accordance  with 
Article  22.

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Article  21

Committees

The  Commission  shall  be  assisted  by 
the  Standing
Veterinary  Committee.  However,  the  Commission  shall
be  assisted  by  the  Standing  Committee  for  Feedingstuffs
or  the  Standing  Committee  for  Foodstuffs  for  matters
falling  exclusively  within  their  respective  competences.

Article  22

Management  procedure

Where  reference  is  made  to  the  procedure  laid  down  in
this  Article,  the  representative  of  the  Commission  shall
submit  to  the  committee  a  draft  of  the  measures  to  be
taken.  The  committee  shall  deliver  its  opinion  on  the
draft  within  a  time  limit  which  the  Chairman  may  lay
down  according  to  the  urgency  of  the  matter.  The
opinion  shall  be  delivered  by  the  majority  laid  down  in
Article  148(2)  of  the  Treaty  in  the  case  of  decisions
which  the  Council  is  required  to  adopt  on  a  proposal
from  the  Commission.  The  votes  of  the  representatives  of
the  committee  shall  be
the  Member  States  within 
weighted  in  the  manner  set  out  in  that  Article.  The
chairman  shall  not  vote.

if  these  measures  are  not 

The  Commission  shall  adopt  measures  which  shall  apply
immediately.  However, 
in
accordance  with  the  opinion  of  the  committee,  they  shall
be  communicated  by  the  Commission  to  the  Council
forthwith.  In  that  event,  the  Commission  may  defer
application  of  the  measures  which  it  has  decided  for  a
period  of  not  more  than  one  month  from  the  date  of
such  communication.

The  Council,  acting  by  a  qualified  majority,  may  take  a
different  decision  within  the  time  limit  referred  to  in  the
previous  paragraph.

Article  23

Regulatory  procedure

Where  reference  is  made  to  the  procedure  laid  down  in
this  Article,  the  representative  of  the  Commission  shall
submit  to  the  committee  a  draft  of  the  measures  to  be
taken.  The  committee  shall  deliver  its  opinion  on  the
draft  within  a  time  limit  which  the  Chairman  may  lay
down  according  to  the  urgency  of  the  matter.  The

opinion  shall  be  delivered  by  the  majority  laid  down  in
Article  148(2)  of  the  Treaty  in  the  case  of  decisions
which  the  Council  is  required  to  adopt  on  a  proposal
from  the  Commission.  The  votes  of  the  representatives  of
the  committee  shall  be
the  Member  States  within 
weighted  in  the  manner  set  out  in  that  Article.  The
chairman  shall  not  vote.

The  Commission  shall  adopt  the  measures  envisaged  if
the
they  are 
committee.

in  accordance  with 

the  opinion  of 

If  the  measures  envisaged  are  not  in  accordance  with  the
opinion  of  the  committee,  or  if  no  opinion  is  delivered,
the  Commission  shall,  without  delay,  submit  to  the
Council  a  proposal  relating  to  the  measures  to  be  taken.
The  Council  shall  act  by  a  qualified  majority.

If,  on  the  expiry  of  a  period  of  three  months  from  the
date  of  referral  to  the  Council,  the  Council  has  not
acted,  the  proposed  measure  shall  be  adopted  by  the
Commission.

Article  24

Consultation  of  scientific  committees

The  appropriate  scientific  committees  shall  be  consulted
on  any  matter  falling  within  the  scope  of  this  Regulation
which  is  likely  to  have  an  effect  on  public  health.

Article  25

Communication  of  national  provisions

The  Member  States 
the
shall 
Commission  the  text  of  all  provisions  of  national  law
which  they  adopt  in  the  field  covered  by  this  Regulation.

communicate 

to 

Article  26

Entry  into  force

This  Regulation  shall  enter  into  force  on  the  twentieth
day  following  that  of 
in  the  Official
Journal  of  the  European  Communities.

its  publication 

It  shall  apply  from  1  July  2000.

This  Regulation  shall  be  binding 
directly  applicable  in  all  Member  States.

in 

its  entirety  and

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ANNEX  I

Definitions

(a) indigenous  case  of  BSE:  a  case  of  BSE  which  has  not  been  clearly  demonstrated  to  originate  directly

from  the  importation  of  live  cattle,  bovine  embryos  or  ova;

(b) batch  of  animals:  a  group  of  animals  slaughtered  after  one  complete  process  of  emptying,  cleaning  and

disinfection  of  the  slaughter  room  and  before  the  next  such  process;

(c) rendered  ruminant  fat:  rendered  fats  derived  in  part  or  entirely  from  ruminant  animals;

(d) mechanically  separated  meat:  residual  meat  obtained  by  mechanical  means  from  flesh(cid:220)bearing  bones  after

initial  boning;

(e) discrete  adipose  tissue:  internal  and  external  body  fat  removed  during  the  slaughter  and  cutting  process,
in  particular  fresh  fat  from  the  heart,  caul,  kidneys  and  mesentery  of  bovine  animals,  and  fat  from
cutting  rooms;

(f) cohort:  a  group  of  animals  which  were  reared  together  during  the  first  year  of  their  life;

(g) ovine  or  caprine  animals  for  breeding  and  fattening:  ovine  and  caprine  animals  intended  to  be  trans(cid:220)
ported  to  the  place  of  destination,  either  directly  or  via  an  approved  market  or  assembly  centre,  other
than  ovine  or  caprine  animals  for  slaughter,  meaning  animals  of  the  ovine  or  caprine  species  intended
to  be  taken  either  directly  or  via  an  approved  market  or  assembly  centre  to  a  slaughterhouse  in  order
to  be  slaughtered  there;

(h) fresh  meat:  fresh  meat  as  defined  by  Council  Directive  64/433/EEC;

(i) minced  meat  and  meat  preparations:  minced  meat  and  meat  preparations  as  defined  by  Directive

94/65/EC;

(j) meat  products:  meat  products  as  defined  by  Directive  77/99/EEC;

(k) official  passport:  passport  as  defined  by  Council  Regulation  (EC)  No  820/97(cid:216)(˛);

(l) official  computerised  identification  and  tracing  system:  a  database  system  as  provided  for  by  Regulation

(EC)  No  820/97.

(˛)(cid:217)OJ  L  117,  7.5.1997,  p.  1.

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ANNEX  II

DETERMINATION  OF  BSE  STATUS

CHAPTER  A

Information  to  be  submitted  in  support  of  an  application  for  recognition  of  risk  classification  under
Article  5

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(cid:220)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)(cid:217)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)(cid:217)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.

3. Animal  feed

(a)(cid:217)domestic  production  of  Meat  and  Bone  Meal  (MBM),  and  its  use  per  species  and  husbandry  system
(in  particular  the  proportion  of  the  domestically  produced  MBM  fed  bovine,  ovine  and  caprine
animals);

(b) imports  of  MBM,  specifying  country  of  origin,  and  its  use  per  species  and  husbandry  system  (in

particular  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)(cid:217)complete  description;

(b) dates  of  introduction;

(c) actual  implementation,  policing  and  compliance  figures;

(d) possibilities  of  cross(cid:220)contamination  with  other  feed.

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5. Specified  bovine  offal  (SBO)  and  specified  risk  materials  (SRM)  bans

(a)(cid:217)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)(cid:217)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;

(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)(cid:217)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  areas  from  which  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)(cid:217)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.

CHAPTER  B

Definition  of  categories

I.(cid:217)For  the  purpose  of  determining  the  BSE  status  of  Member  States  or  regions  thereof,  the  following

categories  are  recommended:

CATEGORY  1

1.(cid:217)a  risk  assessment  based  on  the  information  laid  down  in  Chapter  A  has  demonstrated  that  appro(cid:220)

priate  measures  have  been  taken  to  manage  any  risk  identified;

2.(cid:217)the  measures  laid  down  in  Articles  6,  7,  11,  and  12  have  been  complied  with  for  at  least  seven  years;

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3.(cid:217)all  cases  of  BSE  have  been  clearly  demonstrated  to  originate  directly  from  the  importation  of  live
cattle,  embryos  or  ova  and  the  measures  laid  down  in  Article  12  and  13  have  been  applied  with
respect  to  all  animals  in  which  the  disease  has  been  confirmed.

However,  where  the  measures  laid  down  in  Articles  6  and  7  are  not  complied  with,  the  Member  State
or  region  thereof  may  be  placed  in  Category  1  provided  that:

-(cid:217)the  measures  laid  down  in  Articles  11  and  12  have  been  been  complied  with  for  at  least  seven

years;  and,

-(cid:217)it  has  been  proven  that  for  at  least  eight  years  no  ruminant  meat(cid:220)and(cid:220)bone  meal  has  been  fed  to

ruminants.

However,  where  indigenous  cases  of  BSE  have  occurred,  the  Member  State  or  region  thereof  may  be
placed  in  Category  1  provided  that:

-(cid:217)the  last  indigenous  case  of  BSE  occurred  more  than  seven  years  ago;  and,

-(cid:217)the  measures  laid  down  in  Articles  6,  7,  11,  and  12  have  been  complied  with  for  at  least  seven

years;  and,

-(cid:217)the  measures  laid  down  in  Article  9  are  complied  with  and  have  been  effectively  enforced  for  at

least  eight  years.

CATEGORY  2

1.(cid:217)a  risk  assessment  based  on  the  information  laid  down  in  Chapter  A  has  demonstrated  that  appro(cid:220)

priate  measures  have  been  taken  to  reduce  any  risk  identified;

2.(cid:217)the  measures  laid  down  in  Articles  6,  7,  11,  and  12  are  complied  with,  but  have  not  been  complied

with  for  seven  years;

3.(cid:217)all  cases  of  BSE  have  been  clearly  demonstrated  to  originate  directly  from  the  importation  of  live
cattle,  embryos  or  ova  and  the  measures  laid  down  in  Article  12  and  13  have  been  applied  with
respect  to  all  animals  in  which  the  disease  has  been  confirmed.

However,  where  the  measures  laid  down  in  Articles  6  and  7  are  not  complied  with,  the  Member  State
or  region  thereof  may  be  placed  in  Category  2  provided  that:

-(cid:217)measures  laid  down  in  Articles  11  and  12  are  complied  with  but  have  not  been  complied  with  for

seven  years;  and,

-(cid:217)it  has  been  proven  that  for  at  least  eight  years  no  meat(cid:220)and(cid:220)bone  meal  has  been  fed  to  ruminants.

However,  where  indigenous  cases  of  BSE  have  occurred,  the  Member  State  or  region  thereof  may  be
placed  in  Category  2  provided  that:

-(cid:217)the  last  indigenous  case  of  BSE  occurred  more  than  seven  years  ago;

-(cid:217)the  measures  laid  down  in  Articles  6,  7,  11,  and  12  are  complied  with  but  have  not  been  complied

with  for  seven  years;  or

-(cid:217)the  measures  laid  down  in  Article  9  are  complied  with  but  have  not  been  effectively  enforced  for

eight  years.

However,  where  indigenous  cases  of  BSE  have  occurred  during  the  past  seven  years,  the  Member  State
or  region  thereof  may  be  placed  in  Category  2  provided  that:

-(cid:217)the  measures  laid  down  in  Articles  6,  7,  11,  and  12  have  been  complied  with  for  seven  years;  and,

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-(cid:217)the  BSE  incidence  rate,  calculated  on  the  basis  of  indigenous  cases  during  the  past  12  months,  has
been  less  than  1  case  per  million  within  the  cattle  population  over  24  months  of  age  in  the  Member
State  or  region  thereof.

CATEGORY  3

1.(cid:217)a  risk  assessment  based  on  the  information  laid  down  in  Chapter  A  has  demonstrated  that  appro(cid:220)

priate  measures  have  been  taken  to  reduce  any  risk  identified,

2.(cid:217)the  measures  laid  down  in  Articles  6,  7,  11,  and  12  are  complied  with;

3.(cid:217)the  BSE  incidence  rate,  calculated  on  the  basis  of  indigenous  cases  during  the  past  12  months,  has
been  greater  than  or  equal  to  1  case  per  million  and  less  than  or  equal  to  200  cases  per  million
within  the  cattle  population  over  24  months  of  age  in  the  Member  State  or  region  thereof.

However,  where  the  BSE  incidence  rate,  calculated  on  the  basis  of  indigenous  cases  during  the  past  12
months,  has  been  less  than  1  case  per  million  within  the  cattle  population  over  24  months  of  age  in  the
Member  State  or  region  thereof,  the  Member  State  or  region  thereof  shall  also  be  placed  in  Category
3  if  one  or  more  of  the  requirements  of  points  1  and  2  of  Category  2  are  not  met.

However,  where  there  has  been  no  case  of  BSE,  the  Member  State  or  region  thereof  shall  also  be
placed  in  Category  3  if:

-(cid:217)a  risk  assessment  based  on  the  information  laid  down  in  Chapter  A  has  been  conducted  which

demonstrates  the  presence  of  one  or  more  risk  factors;  and,

-(cid:217)the  measures  laid  down  in  Articles  11  and  12  are  not  complied  with.

CATEGORY  4

1.(cid:217)a  risk  assessment  based  on  the  information  laid  down  in  Annex  II  Chapter  A  has  demonstrated  that

appropriate  measures  have  been  taken  to  reduce  any  risk  identified;

2.(cid:217)the  measures  laid  down  in  Articles  6,  7,  11,  and  12  are  complied  with;

3.(cid:217)the  BSE  incidence  rate,  calculated  on  the  basis  of  indigenous  cases  during  the  past  12  months,  has
been  greater  that  200  cases  per  million  within  the  cattle  population  over  24  months  of  age  in  the
Member  State  or  region  thereof.

However,  where  the  BSE  incidence  rate,  calculated  on  the  basis  of  indigenous  cases  during  the  past  12
months,  has  been  greater  than  or  equal  to  1  case  per  million  and  less  than  or  equal  to  200  cases  per
million  within  the  cattle  population  over  24  months  of  age  in  the  Member  State  or  region  thereof,  the
Member  State  or  region  thereof  shall  be  placed  in  Category  4  if  one  or  more  of  the  requirement  of
point  1  or  the  measures  laid  down  in  Articles  6,  7,  11,  and  12  are  not  met.

Where  a  Member  State  or  region  thereof  should  be  placed  in  Category  4  pursuant  to  the  criterion  of
point  3,  but  one  or  more  of  the  requirement  of  point  1  and  the  measures  laid  down  in  Articles  6,  7,  11,
and  12  are  not  met,  the  Member  State  or  region  thereof  shall  be  placed  in  Category  4  and  Article  4
applies.

II.(cid:217)For  the  purpose  of  determining  the  BSE  status  of  third  countries  or  regions  thereof,  the  same  four
categories  on  the  basis  of  equivalent  health  guarantees  shall  be  defined  providing  equivalent  health
guarantees  to  those  referred  to  in  Part  I.

III.(cid:217)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  numercial  BSE  category.

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ANNEX  III

MONITORING  SYSTEM

CHAPTER  A

Minimal  requirements  for  a  programme  for  monitoring  of  BSE  and  scrapie

Selection  of  subpopulation

Without  prejudice  to  Article  12,  selection  must  be  by  means  of  a  risk  assessment  of  subpopulations  of
native(cid:220)born  animals  displaying  clinical  signs  compatible  with  TSEs  and,  in  a  decreasing  order  of  relevance,
of  higher(cid:220)risk  animals.  Within  each  subpopulation  and  age  group,  selection  must  be  random.

Animals  examined  in  accordance  with  Article  12  may  be  included  in  the  sample.

1. Criteria  for  the  selection  of  native(cid:220)born  animals  displaying  clinical  signs  compatible  with  TSEs:

-(cid:217)animals  displaying  behavioural  or  neurological  signs  lasting  for  at  least  15  days  and  resistant  to
treatment.  However,  animals  displaying  such  signs  which  die  within  15  days  and  in  which  case  an
alternative  diagnosis  has  not  been  identified,  should  be  considered  as  suspect  animals.  They  shall  be
examined  in  accordance  with  Article  12  and  may  be  included  in  the  monitoring  programme;

-(cid:217)moribund  animals  without  signs  of  infectious  or  traumatic  illness;

-(cid:217)animals  displaying  other  progressive  disease  conditions.

2.(cid:217)The  following  risks  must  be  taken  into  account  for  the  selection  of  higher  risk  animals:

-(cid:217)animals  originating  from  countries  with  indigenous  TSE;

-(cid:217)animals  which  have  consumed  potentially  contaminated  feedingstuffs;

-(cid:217)animals  born  or  derived  from  TSE  infected  dams  or  sires.

Animal  species  and  type  of  TSE

1.(cid:217)Bovine  animals  must  be  examined  for  the  presence  of  BSE.

2.(cid:217)Ovine  and  caprine  animals  must  be  examined  for  the  presence  of  scrapie  and  BSE.

Age  of  the  targeted  animals

The  sample  must  target  the  oldest  animals  in  the  subpopulation.  However,  all  targeted  bovine  animals  must
be  over  20  months  of  age  and  all  targeted  ovine  and  caprine  animals  must  be  over  12  months  of  age.
Targeted  bovine  animals  displaying  progressive  disease  conditions  without  showing  neurological  signs  must
be  over  four  years  of  age.

Sample  size

The  minimum  number  of  animals  to  be  examined  on  an  annual  basis  must  comply  at  least  with  the  sample
sizes  referrd  to  in  the  Table  for  animals  in  subpopulations  of  native(cid:220)born  animals  displaying  clinical  signs
compatible  with  TSEs.  Suspected  animals  which  have  been  examined  in  accordance  with  Article  12  may  be
included  within  the  minimum  sample  size.

Samples  from  the  subpopulations  of  higher(cid:220)risk  animals  must  be  collected  at  the  time  when  the  animals  are
slaughtered  or  killed.

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Table

Minimum  number  of  annual  neurohistological  investigations  of  animals  showing  clinical  signs  compatible
with  TSE

Native(cid:220)born  cattle  population  20  months  of  age
or  older  or  native(cid:220)born  ovine  and  caprine  population
12  months  of  age  or  older

Minimum  number  of  brains  to  be  examined

100(cid:216)000

300(cid:216)000

500(cid:216)000

700(cid:216)000

1(cid:216)000(cid:216)000

2(cid:216)500(cid:216)000

5(cid:216)000(cid:216)000

7(cid:216)000(cid:216)000

10(cid:216)000(cid:216)000

20(cid:216)000(cid:216)000

30(cid:216)000(cid:216)000

40(cid:216)000(cid:216)000

10

30

50

69

99

195

300

336

367

409

425

433

CHAPTER  B

Annual  report

The  annual  report  must  contain  data  on:

1.(cid:217)the  total  number  of  animals  and  age  structure  examined  within  the  different  groups  of  the  respective

populations  of  bovine,  ovine  and  caprine  animals  categorized  according  to  epidemiological  criteria;

2.(cid:217)the  overall  mortality  and  mortality  due  to  neurological  diseases  per  animal  species;

3.(cid:217)official  records  on  the  number  and  types  of  animals  or  carcases  placed  under  movement  restrictions  in

accordance  with  Article  12;

4.(cid:217)the  number  and  outcome  of  the  investigations  carried  out  in  accordance  with  Article  12;  these  records

must  be  kept  for  at  least  seven  years;

5.(cid:217)TSEs  in  animals  other  than  bovine,  ovine  and  caprine  animals;

6.(cid:217)training,  in  particular  of  official  veterinarians  with  responsibilities  for  the  epidemiosurveillance  of  TSEs,

in  accordance  with  Article  6.

ANNEX  IV

Specified  risk  material

1.(cid:217)The  following  tissues  shall  be  designated  as  specified  risk  materials  depending  on  the  category  of  origin

or  residence  of  the  animal,  determined  in  accordance  with  Article  5:

CATEGORY  1

No  tissues  are  designated  as  specified  risk  materials.

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CATEGORY  2

In  countries  or  regions  thereof  placed  in  Category  2  the  following  are  only  designated  as  specified  risk
materials  where  BSE  has  occurred(cid:216)(˛):

(a)(cid:217)the  brain  and  spinal  cord  of:

-(cid:217)bovine  animals  aged  over  30  months,

-(cid:217)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.

CATEGORY  3

(a)(cid:217)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.

CATEGORY  4 (˛)

(a)(cid:217)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,  spinal  cord  and  dura  mater  of  bovine  animals  aged
over  six  months  and  of  ovine  and  caprine  animals  aged  over  12  months;

(b) and  other  bones  of  bovine  animals  aged  over  30  months;

(c) the  distal  ileum  and  spleen  of  bovine,  ovine  and  caprine  animals  of  all  ages.

2.(cid:217)Member  States  shall  ensure  that  the  specified  risk  materials  are  removed  at  slaughterhouses.

However,  in  Member  States  or  regions  thereof  which  are  not  placed  in  Categroy  4,  the  removal  and
subsequent  destruction  according  to  point  4  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  VI.

3.(cid:217)By  way  of  derogation  from  point  2,  Member  States  may  allow  the  removal  of:

(a)(cid:217)specified  risk  material  at  cutting  plants,  high  risk  processing  plants  or  premises  referred  to  in  Article
7  of  Council  Directive  90/667/EEC(cid:216)(ˇ),  under  the  direct  supervision  of  an  official  of  the  competent
authority.  Those  establishments  shall  be  approved  for  that  purpose  by  the  competent  authority;

(˛)(cid:217)Peding  OIE  confirmation  during  the  legislative  process.
(ˇ)(cid:217)OJ  L  363,  27.12.1990,  p.  51.

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(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  4.

4. 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)(cid:217)by  direct  incineration;  or,

(b) provided  that  the  colour  of  the  dye  is  detectable  after  processing,  by  processing  followed  by:

(i)(cid:217)incineration;

(ii)(cid:217)burning  as  fuel;  or,

(iii)(cid:217)another  method,  which  precludes  all  risk  of  transmission  of  a  TSE,  and  is  authorised  and

supervised  by  the  competent  authority.

5. Without  prejudice  to  Articles  12  and  13,  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.

6. Member  States  may  derogate  from  the  provisions  of  points  2  and  4  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.

7. The  application  of  a  test  as  an  alternative  to  the  removal  of  specified  risk  materials  may  be  authorised

under  the  following  conditions:

(a)(cid:217)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  slaught(cid:220)
erhouse  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(cid:220)slaughter  test  gives  a  positive  result,  all  bovine,  ovine  and  caprine  material  produced  in

the  same  batch  is  destroyed  in  accordance  with  point  4.

8. By  way  of  derogation  from  Article  8  the  Commission  may;

(a)(cid:217)acting  in  accordance  with  the  procedure  laid  down  in  Article  22,  take  a  decision  in  respect  of  the
date  of  effective  enforcement  of  the  provisions  of  Article  9(1),  or  as  appropriate,  the  prohibition  on
the  feeding  of  mammalian  protein  to  ruminants  in  each  country  or  region  thereof  placed  in
Category  2  or  3,  and  allow  the  provisions  of  Article  8  to  be  confined  to  animals  which  were  born
before  that  date  in  those  countries  or  regions;

(b) after  consultation  of  the  appropriate  scientific  committee  and  based  on  an  assessment  of  the
incident,  propagation  and  human  exposure  risk,  acting  in  accordance  with  the  procedure  laid  down
in  Article  22,  take  a  decision  to  allow  the  use  of  vertebral  column  and  dorsal  root  ganglia  for  food,
feed  and  fertilisers  from  animals  in  or  coming  from  each  country  or  region  thereof  in  Category  4.

9. 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.

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ANNEX  V

Animal  feeding

The  prohibition  laid  down  in  Article  9(1)  and  (2)  shall  not  apply  to  the  following  products:

(a)(cid:217)milk  and  milk  products;

(b) hydrolised  proteins  derived  from  fleshings  from  hides;

(c) dried  plasma  and  other  blood  products.

The  prohibition  laid  down  in  Article  9(2)(b)  shall  not  apply  to  the  production  of  dog  food.

ANNEX  VI

Standards  for  certain  products  of  animal  origin  derived  from  or  containing  ruminant  material

1. Conditions  for  production  of  certain  products  of  animal  origin  as  referred  to  in  Article  10(1)

The  use  of  ruminant  material  for  the  production  of  the  following  products  of  animal  origin  is
prohibited:

(a)(cid:217)mechanically  separated  meat;

(b) dicalcium  phosphate  destined  for  feeding  to  all  farmed  animals;

(c) gelatine,  unless  it  is  produced  from  ruminant  hides;

(d) rendered  ruminant  fat  derivatives;

(e) rendered  ruminant  fat,  unless  it  is  produced  from:

(i)(cid:217)discrete  adipose  tissue,  which  itself  was  found  fit  for  human  consumption;

(ii)(cid:217)raw  material  which  has  been  processed  in  accordance  with  the  standards  laid  down  pursuant  to

Directive  90/667/EEC.

The  prohibition  on  the  use  of  ruminant  material  shall  not  apply  to  material  derived  from  animals  which
have  been  tested  in  accordance  with  Annex  IV,  point  7,  and  have  given  a  negative  result.

2. Appropriate  production  processes

For  rendered  ruminant  fat  derivatives  derived  from  ruminant  materials  for  use  in  the  production  of
human  food,  animal  feed  or  fertilisers:  validated  and  strictly  certified  methods  such  as:

1.(cid:217)Transesterification  or  hydrolysis  at  not  less  than  200(cid:216)›C  for  not  less  than  20  minutes  under  pressure

(glycerol,  fatty  acids  and  fatty  acid  esters  production);  or,

2.(cid:217)Saponification  with  NaOH  12M  (glycerol  and  soap  production):

-(cid:217)in  a  batch  process:  at  not  less  than  95(cid:216)›C  for  not  less  than  three  hours;  or

-(cid:217)in  a  continuous  process:  at  not  less  than  140(cid:216)›C,  two  bars  for  not  less  than  eight  minutes,  or

equivalent.

Moreover,  other  tallow  deriviatives  (e.g.  fatty  alcohols,  fatty  amines,  fatty  amides)  produced  from  the
abovementioned  products  and  submitted  to  further  processes  may  also  be  used.

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ANNEX  VII

Eradication  of  transmissible  spongiform  encephalopathy

1.(cid:217)The  inquiry  referred  to  in  Article  13(1)(b)  shall  identify:

(a)(cid:217)in  the  case  of  bovine  animals:

-(cid:217)all  embryos,  ova  and  first  generation  progeny  of  a  female  animal  in  which  the  disease  was
confirmed  and  which  embryos  or  progeny  were  collected  or  born  after  or  within  two  years
before  clinical  onset  or  diagnosis  of  the  disease  in  its  dam;

-(cid:217)all  animals  of  the  cohort  of  the  animal  in  which  the  disease  was  confirmed;

-(cid:217)the  possible  origin  of  the  disease  and  other  holdings  on  which  there  are  animals  which  may  have

become  infected  by  the  TSE  agent  or  exposed  the  the  same  feed  or  contamination  source;

-(cid:217)the  movement  of  potentially  contaminated  feedingstuffs,  animals,  ova,  semen  or  embryos,  or  any
other  means  of  transmission,  which  may  have  transmitted  the  TSE  agent  to  or  from  the  holding
in  question.

(b) in  the  case  of  ovine  and  caprine  animals:

-(cid:217)all  other  ruminants  on  the  holding  of  the  animal  in  which  the  disease  was  confirmed;

-(cid:217)the  parents,  all  semen,  embryos,  ova,  and  first  generation  progeny  of  the  animal  in  which  the

disease  was  confirmed;

-(cid:217)all  animals  of  the  cohort  of  the  animal  in  which  the  disease  was  confirmed;

-(cid:217)the  possible  origin  of  the  disease  and  the  identification  of  other  holdings  on  which  there  are
animals  which  may  have  become  infected  by  the  TSE  agent  or  exposed  to  the  same  feed  or
contamination  source;

-(cid:217)the  movement  of  potentially  contaminated  feedingstuffs,  animals,  ova,  semen  or  embryos,  or  any
other  means  of  transmission,  which  may  have  transmitted  the  TSE  agent  to  or  from  the  holding
in  question.

2.(cid:217)The  requirement  of  Article  13(2)  shall:

(a)(cid:217)in  case  of  confirmation  of  BSE  in  a  bovine  animal,  apply  to  bovine  animals,  embryos  and  ova

identified  by  the  inquiry  referred  to  in  point  1(a),  first  and  second  indent;

(b) in  case  of  confirmation  of  BSE  in  an  ovine  or  caprine  animal,  apply  to  all  ruminant  animals,
embryos  and  ova  and  ovine  and  caprine  semen  identified  by  the  inquiry  referred  to  in  point  1(b),
first  to  fifth  indent.

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ANNEX  VIII

PLACING  ON  THE  MARKET  OF  LIVE  ANIMALS,  SEMEN,  EMBRYOS  AND  OVA

CHAPTER  A

Conditions  for  placing  on  the  market

I. Conditions  which  apply  irrespective  of  the  category  of  the  country  of  origin  or  residence  of  the  animal

1.(cid:217)The  conditions  as  referred  to  in  Article  15(1)  shall  apply  to  movements  relating  to:

-(cid:217)dispatch  to  other  Member  States;

-(cid:217)dispatch  to  third  countries;

-(cid:217)import  into  the  Community  from  third  countries.

2.(cid:217)The  following  conditions  shall  apply  to  movements  as  referred  to  in  point  1  of  bovine  embryos  and

ova:

Bovine  embryos  and  ova  shall  be  derived  from  female  animals  which,  at  the  time  of  collection:

-(cid:217)were  not  suspected  of  being  affected  by  BSE;

-(cid:217)themselves  complied  with  the  conditions  laid  down  in  Part  II.

3.(cid:217)The  following  conditions  shall  apply  to  movements  as  referred  to  in  point  1  of  ovine  and  caprine

animals:

Ovine  or  caprine  animals  for  breeding  or  fattening  shall:

(a)(cid:217)come  from  a  holding  satisfying  the  following  requirements:

-(cid:217)the  animals  are  identified;

-(cid:217)no  case  of  scrapie  has  been  confirmed  for  at  least  two  years;

-(cid:217)checking  by  sampling  is  carried  out  at  slaughter  on  old  female  animals,  intended  for  culling

coming  from  that  holding;

-(cid:217)female  animals  are  only  introduced  into  that  holding  if  they  come  from  a  holding  which

complies  with  the  same  requirements;

(b) have  been  continuously  kept  on  a  holding  or  holdings  complying  with  the  requirements  laid

down  in  point  (a)  since  birth  or  for  the  last  two  years.

4.(cid:217)Ovine  or  caprine  animals  imported  into  the  Community  shall  meet  requirements  which  provide
equivalent  health  guarantees  to  those  required  by  this  Regulation  or  pursuant  to  this  Regulation.

II. Conditions  which  apply  depending  on  the  category  of  the  country  of  origin  or  residence  of  the  animal

determined  in  accordance  with  Annex  II,  Chapter  B

1.(cid:217)The  conditions  as  referred  to  in  Article  15(1)  shall  apply  to  movements  relating  to:

-(cid:217)dispatch  to  other  Member  States;

-(cid:217)dispatch  to  third  countries;

-(cid:217)import  into  the  Community  from  third  countries.

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2.(cid:217)The  BSE  category  of  bovine,  ovine  and  caprine  animals  shall  be  communicated  to  the  Member  State

of  destination.

3.(cid:217)The  following  conditions  shall  apply  to  movements  as  referred  to  in  point  1  of  bovine  animals

coming  from  or  having  resided  in  countries  or  regions  thereof  placed  in:

Category  2  and  3

The  animals  must  have:

(a)(cid:217)been  born,  raised  and  have  remained  in  herds  in  which  no  case  of  BSE  had  been  confirmed  for

at  least  seven  years;  or

(b) been  born  after  the  date  at  which  ban  on  the  feeding  or  ruminants  with  meat(cid:220)and(cid:220)bone  meal

derived  from  mammalians  has  been  effectively  enforced.

In  addition,  bovine  animals  imported  into  the  Community  shall  come  from  a  country  or  region
thereof  in  which:

(a)(cid:217)the  BSE  affected  cattle  are  killed  and  completely  destroyed;

(b) the  feeding  of  ruminants  with  meat(cid:220)and(cid:220)bone  meal  derived  from  mammalians  has  been  banned

and  the  ban  has  been  effectively  enforced.

Category  4

The  animals  must  have:

(a)(cid:217)never  been  fed  mammalian  meat(cid:220)and(cid:220)bone  meal  and  been  born  after  the  date  at  which  the  ban
on  the  feeding  of  farmed  animals  with  meat(cid:220)and(cid:220)bone  meal  derived  from  mammalians  has  been
effectively  enforced;

(b) been  born,  raised  and  have  remained  in  herds  in  which  no  case  of  BSE  had  been  confirmed  for
at  least  seven  years,  and  which  contain  only  cattle  born  on  the  farm  or  coming  from  a  herd  of
equal  status.

In  addition,  bovine  animals  imported  into  the  Community  shall  come  from  a  country  or  a  region
thereof  in  which  the  BSE  affected  cattle  are  killed  and  completely  destroyed.

CHAPTER  B

Identification  of  live  animals  on  import

The  requirement  laid  down  in  Article  15(2)  shall  apply  to:  bovine  animals.

Conditions  relating  to  progeny  of  TSE  suspect  or  confirmed  animals  referred  to  in  Article  15(3)

CHAPTER  C

It  is  prohibited  to  place  on  the  market:

-(cid:217)the  first  generation  progeny,  embryos  and  ova  of  TSE  suspect  or  confirmed  female  bovine  animals;

-(cid:217)the  first  generation  progeny,  semen,  embryos  and  ova  of  BSE  confirmed  ovine  and  caprine  animals.

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CHAPTER  D

Animal  health  certificates

1.(cid:217)The  certificates  referred  to  in  Article  15(1)  shall  be  required  for  animals  and  semen,  embryos  and  ova  of

those  animals  when:

-(cid:217)dispatched  to  other  Member  States;

-(cid:217)imported  into  the  Community  from  third  countries.

2.(cid:217)The  certificates  shall  be  supplemented  in  accordance  with  the  following  conditions:

(a) Intra(cid:220)Community  trade  in  bovine  animals

The  animal  health  certificates  referred  to  in  Annex  F  to  Council  Directive  64/432/EEC(cid:216)(˛)  shall  be
supplemented  by  the  following  words  to  be  entered  in  the  section  "Health  data  concerning  bovine
animals’:

"The  animals  listed  below  comply  with  the  conditions  laid  down  in  Regulation  (EC)  No  .(cid:216).(cid:216)./.(cid:216).(cid:216).
of  the  European  Parliament  and  of  the  Council,  and  their  BSE  category  is  Category  .(cid:216).(cid:216).(cid:216)(*).
This  category  was  established  by  Commission  Decision  .(cid:216).(cid:216)./.(cid:216).(cid:216)./EC(cid:216)(**);

(*)(cid:217)Complete  as  appropriate  with  1,  2,  3  or  4.
(**)(cid:217)Complete.’

(b) Intra(cid:220)Community  trade  in  ovine  and  caprine  animals

The  animals  health  certificates  corresponding  to  Model  III  in  Annex  E  to  Council  Directive
91/68/EEC(cid:216)(ˇ)  shall  be  supplemented  by  the  following  words  to  be  entered  in  section  V  "Health
information’:

"BSE  category  of  the  animals  listed  below:  Category  .(cid:216).(cid:216).(cid:216)(*).  This  category  was  established  by
Commission  Decision  .(cid:216).(cid:216)./.(cid:216).(cid:216)./EC(cid:216)(**);

(*)(cid:217)Complete  as  appropriate  with  1,  2,  3  or  4.
(**)(cid:217)Complete.’

Point  (e)  of  section  V  "Health  information’  of  the  certificate  corresponding  to  Model  III  in  Annex  E
to  Council  Directive  91/68/EEC  states  that:

"(e)(cid:217)they  meet  the  requirements  with  regard  to  scrapie  laid  down  in  Article  15  of  Regulation

(EC)  No  .(cid:216).(cid:216)./.(cid:216).(cid:216).  of  the  European  Parliament  and  of  the  Council’.

(c) Intra(cid:220)Community  trade  in  bovine  embryos  and  ova

The  appropriate  animal  health  certificates  as  laid  down  in  Community  rules  on  trade  in  bovine
embryos  and  ova  shall  be  supplemented  by  the  following  words  to  be  entered  in  the  section  on
health  data:

"The  embryos  and  ova  were  derived  from  females  which,  at  the  time  of  collection,  were  not
suspected  of  being  affected  by  BSE,  and  which  themselves  complied  with  the  conditions  laid
down  in  Regulation  (EC)  No  .(cid:216).(cid:216)./.(cid:216).(cid:216).  of  the  European  Parliament  and  of  the  Council.

The  BSE  category  of  the  Member  State,  or  region  within  a  Member  State,  in  which  the
embryos  or  ova  were  collected, 
.(cid:216).(cid:216).(cid:216)(*).  This  category  was  established  by
Commission  Decision  .(cid:216).(cid:216)./.(cid:216).(cid:216)./EC(cid:216)(**);

is  Category 

(*)(cid:217)Complete  as  appropriate  with  1,  2,  3  or  4.
(**)(cid:217)Complete.’

(˛)(cid:217)OJ  121,  29.7.1964,  p.  1977/64.
(ˇ)(cid:217)OJ  L  46,  19.2.1991,  p.  19.

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(d) Intra(cid:220)Community  trade  in  ovine  or  caprine  semen,  embryos  or  ova

The  appropriate  animal  health  certificates  as  laid  down  in  Community  rules  on  trade  in  ovine  or
caprine  semen,  embryos  and  ova,  shall  be  supplemented  by  the  following  words  to  be  entered  in  the
section  on  health  data:

"The  semen,  embryos  and  ova  were  derived  from  donor  animals  which,  at  the  time  of
collection,  were  not  suspected  of  being  affected  by  either  BSE  or  scrapie,  and  which  them(cid:220)
selves  complied  with  the  conditions  laid  down  in  Regulation  (EC)  No  .(cid:216).(cid:216)./.(cid:216).(cid:216).  of  the  European
Parliament  and  of  the  Council.

The  BSE  category  of  the  Member  State,  or  region  within  a  Member  State,  in  which  the  semen,
embryos  or  ova  were  collected, 
.(cid:216).(cid:216).(cid:216)(*).  This  category  was  established  by
Commission  Decision  .(cid:216).(cid:216)./.(cid:216).(cid:216)./EC(cid:216)(**);

is  Category 

(*)(cid:217)Complete  as  appropriate  with  1,  2,  3  or  4.
(**)(cid:217)Complete.’

(e) Import  into  the  Community  of  bovine,  ovine  and  caprine  animals

The  appropriate  certificates,  as  required  by  Community  legislation,  shall  be  supplemented  by  the
following  words:

"The  animals 
listed  below  provide  equivalent  guarantees  to  those  of  Regulation  (EC)
No  .(cid:216).(cid:216)./.(cid:216).(cid:216).  of  the  European  Parliament  and  of  the  Council  and  their  BSE  category  is
Category  .(cid:216).(cid:216).(cid:216)(*).  This  category  was  established  by  Commission  Decision  .(cid:216).(cid:216)./.(cid:216).(cid:216)./EC(cid:216)(**);

(*)(cid:217)Complete  as  appropriate  with  1,  2,  3  or  4.
(**)(cid:217)Complete.’

(f)

Import  into  the  Community  of  bovine  embryos  and  ova

The  appropriate  certificates,  as  required  by  Community  legislation,  shall  be  supplemented  by  the
following  words:

"The  embryos  and  ova  were  derived  from  females  which,  at  the  time  of  collection,  were  not
suspected  of  being  affected  by  BSE,  and  which  themselves  provide  guarantees  equivalent  to
those  of  Regulation  (EC)  No  .(cid:216).(cid:216)./.(cid:216).(cid:216).  of  the  European  Parliament  and  of  the  Council.

The  BSE  category  of  the  country,  or  region  within  a  country,  in  which  the  embryos  or  ova
were  collected,  is  Category  .(cid:216).(cid:216).(cid:216)(*).  This  category  was  established  by  Commission  Decision
.(cid:216).(cid:216)./.(cid:216).(cid:216)./EC(cid:216)(**);

(*)(cid:217)Complete  as  appropriate  with  1,  2,  3  or  4.
(**)(cid:217)Complete.’

(g) Import  into  the  Community  of  ovine  or  caprine  semen,  embryos  or  ova

The  appropriate  certificates,  as  required  by  Community  legislation,  shall  be  supplemented  by  the
following  words:

"The  semen,  embryos  and  ova  were  derived  from  donor  animals  which,  at  the  time  of
collection,  were  not  suspected  of  being  affected  by  either  BSE  or  scrapie,  and  which  them(cid:220)
selves  provide  guarantees  equivalent  to  those  of  Regulation  (EC)  No  .(cid:216).(cid:216)./.(cid:216).(cid:216).  of  the  European
Parliament  and  of  the  Council.

The  BSE  category  of  the  country,  or  region  within  a  country,  in  which  the  semen,  embryos  or
ova  were  collected,  is  Category  .(cid:216).(cid:216).(cid:216)(*).  This  category  was  established  by  Commission  Decision
.(cid:216).(cid:216)./.(cid:216).(cid:216)./EC(cid:216)(**);

(*)(cid:217)Complete  as  appropriate  with  1,  2,  3  or  4.
(**)(cid:217)Complete.’

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19.2.1999

ANNEX  IX

PLACING  ON  THE  MARKET  OF  BOVINE,  OVINE  OR  CAPRINE  MEAT  AND  CERTAIN
PRODUCTS  OF  ANIMAL  ORIGIN

CHAPTER  A

Conditions  for  placing  on  the  market

I.(cid:217)The  following  products  of  animal  origin  are  exempt  from  the  prohibition  referred  to  in  Article  16(2),

provided  that  they  are  derived  from  animals  that  comply  with  the  conditions  of  Article  16(3):

-(cid:217)fresh  meat;

-(cid:217)minced  meat;

-(cid:217)meat  preparations;

-(cid:217)meat  products;

-(cid:217)food  which  is  destined  for  domestic  carnivores.

Date(cid:220)based  Scheme  (DBS)

II.(cid:217)Deboned  fresh  meat  of  which  all  adherent  tissues,  including  obvious  nervous  and  lymphatic  tissue  has
been  removed,  and  the  products  of  animal  origin  referred  to  in  Part  I  therefrom,  derived  from  eligible
animals  from  countries  or  regions  thereof  in  Category  4  may  be  marketed  in  accordance  with  Article
16(3)(a)  when  obtained  from  animals  born  after  the  date  at  which  the  animal  feeding  standards  laid
down  in  Article  9  were  effectively  enforced,  and  which  are  certified  to  meet  the  conditions  laid  down
in  point  1  and  produced  in  establishments  which  meet  the  condition  laid  down  in  point  10.  The
competent  authority  shall  ensure  that  the  conditions  with  respect  to  controls,  laid  down  in  points  2  to
8  and  10,  are  complied  with.

1.(cid:217)(a)(cid:217)The  animal  is  clearly  identified,  enabling  it  to  be  traced  back  to  the  dam  and  herd  of  origin;  its
unique  eartag  number,  date  and  holding  of  birth  and  all  movements  after  birth  are  recorded
either  in  the  animal’s  official  passport  or  on  an  official  computerised  identification  and  tracing
system;  the  identity  of  its  dam  is  known;

(b) the  animal  is  more  than  six  months  but  less  than  30  months  of  age,  determined  by  reference  to

an  official  computer  record  of  its  date  of  birth,  or  to  the  animal’s  official  passport;

(c) the  competent  authority  has  obtained  and  verified  positive  evidence  that  the  dam  of  the  animal

has  lived  for  at  least  six  months  after  the  birth  of  the  eligible  animal;

(d) the  dam  of  the  animal  has  not  developed  BSE  and  is  not  suspected  of  having  contracted  BSE.

Controls

2.(cid:217)If  any  animal  presented  for  slaughter  or  any  circumstance  surrounding  its  slaughter  does  not  meet
all  of  the  requirements  of  this  Regulation,  the  animal  must  be  automatically  rejected  and  its
passport  withheld.  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  of  desti(cid:220)
nation.  The  competent  authority  of  the  place  of  destination  must  take  the  appropriate  measures.

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3.(cid:217)Slaughter  of  eligible  animals  must  take  place  in  slaughterhouses  exclusively  used  for  slaughter  of

animals  under  a  Date(cid:220)based  Scheme  or  under  a  Certified  Animal  Scheme.

4.(cid:217)The  competent  authority  must  ensure  that  procedures  used  in  the  cutting  plants  ensure  that  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.

5.(cid:217)Meat  must  be  traceable  back  to  the  eligible  animal,  or  after  cutting,  to  the  animals  cut  in  the  same
batch,  by  means  of  an  official  tracing  system  until  the  time  of  slaughter.  After  slaughter,  labels
must  be  capable  of  tracing  fresh  meat  and  products  referred  to  in  Part  I  back  to  the  eligible  animal
to  enable  the  consignment  concerned  to  be  recalled.  In  case  of  petfood  accompanying  documents
and  records  must  enable  tracing.

6.(cid:217)All  approved  eligible  carcasses  must  have  individual  numbers  correlated  with  the  eartag  number.

7.(cid:217)The  Member  State  must  have  detailed  protocols  in  place  covering:

(a)(cid:217)tracing  and  controls  prior  to  slaughter;

(b) controls  during  slaughter;

(c) processing  of  petfood;

(d) all  labelling  and  certification  requirements  after  slaughter  to  the  point  of  sale.

8.(cid:217)The  competent  authority  must  set  up  a  system  for  recording  checks  on  compliance  so  that  control

can  be  demonstrated.

The  establishment

9.(cid:217)To  obtain  approval,  the  establishment  must  devise  and  implement  a  system  whereby  the  eligible
meat  and/or  eligible  product  is  identifiable  and  all  meat  can  be  traced  back  to  the  eligible  animal,
or  after  cutting,  to  the  animals  cut  in  the  same  batch.  The  system  must  facilitate  full  traceability  of
the  meat  or  products  of  animal  origin  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  of  the
establishment  to  the  competent  authority.

10.(cid:217)The  competent  authority  must  assess,  approve  and  monitor  the  system  provided  by  the  estab(cid:220)
lishment  in  order  to  ensure  that  it  provides  full  segregation  and  traceability  both  backwards  and
forwards.

Certified  Animal  Scheme  (CAS)

III.(cid:217)Deboned  fresh  meat  of  which  all  adherent  tissues,  including  obvious  nervous  and  lymphatic  tissue  has
been  removed,  and  the  products  of  animal  origin  referred  to  in  Part  I  therefrom,  derived  from  eligible
animals  from  countries  or  regions  thereof  in  Category  4,  may  be  marketed  in  accordance  with  Article
16(3)(b)  when  obtained  from  animals  which  are  certified  to  meet  the  conditions  laid  down  in  point  2
and  coming  from  herds  in  which  no  case  of  BSE  has  occurred  in  the  last  seven  years  and  which  are
certified  to  meet  the  conditions  laid  down  in  point  1  and  produced  in  establishments  which  meet  the
condition  laid  down  in  point  11.  The  competent  authority  shall  ensure  that  the  conditions  with  respect
to  the  computerised  tracing  system  and  the  controls,  laid  down  in  points  3  to  10  and  12,  are  complied
with.

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19.2.1999

Herd  conditions

1.(cid:217)(a)(cid:217)A  herd  is  a  group  of  animals  forming  a  separate  and  distinct  unit,  that  is  a  group  of  animals
which  is  managed,  housed  and  kept  separately  from  any  other  group  of  animals  and  which  is
identified  with  unique  herd  and  animal  identification  numbers.

(b) A  herd  is  eligible  when  for  at  least  seven  years,  there  has  been  no  confirmed  case  of  BSE,  nor
a  suspect  case  for  which  the  diagnosis  of  BSE  has  not  been  ruled  out,  in  any  animal  which  was
still  in  or  had  moved  through  or  from  the  herd.

(c) As  an  exception  to  the  provisions  in  point  (b),  a  herd  that  has  been  in  existence  for  less  than
seven  years  may  be  considered  eligible,  after  a  thorough  investigation  by  the  competent
veterinary  authority,  on  condition  that:

(i)(cid:217)all  animals  born  or  moved  into  the  newly  established  herd  complied  with  the  conditions  set

out  in  point  2(a),  (d)  and  (e);  and,

(ii)(cid:217)the  herd  has  complied  with  the  conditions  set  out  in  point  (b)  during  its  entire  existence.

(d) If  a  herd  is  newly  established  on  a  holding  which  experienced  a  confirmed  case  of  BSE  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  investigation  by  the  competent  veterinary
authority,  taking  into  account  compliance  with  each  of  the  following  conditions  to  the  satis(cid:220)
faction  of  that  authority:

(i)(cid:217)all  animals  of  the  affected  herd  previously  established  on  the  same  holding  have  been

removed  or  killed;

(ii)(cid:217)all  feed  has  been  removed  and  destroyed  and  all  feed  containers  thoroughly  cleansed;

(iii)(cid:217)all  buildings  have  been  emptied  and  thoroughly  cleansed  before  the  new  animals  were

admitted;

(iv) all  conditions  set  out  in  point  (c)  have  been  complied  with.

Animal  conditions

2.(cid:217)(a)(cid:217)all  records  of  its  birth,  identity  and  movements  are  recorded  on  an  official  computerised

tracing  system;

(b) it  is  more  than  six  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  six  months  after  its  birth;

(d) its  dam  has  not  developed  BSE  and  is  not  suspected  of  having  contracted  BSE;

(e) the  herd  of  birth  of  the  animal  and  all  herds  through  which  it  has  ever  moved  are  eligible.

Computerised  tracing  system

3.(cid:217)The  official  computerised  tracing  system  referred  to  in  point  2(a)  will  be  accepted  only  where  it
has  been  in  operation  for  sufficient  time  to  contain  all  the  information,  relating  to  the  lifetime  and
movements  of  the  animals,  needed  to  check  compliance  with  the  requirements  of  this  Regulation,
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.

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Controls

4.(cid:217)If  any  animal  presented  for  slaughter  or  any  circumstance  surrounding  its  slaughter  does  not  meet
all  of  the  requirements  of  this  Regulation,  the  animal  must  be  automatically  rejected  and  its
passport  withheld.  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  of  desti(cid:220)
nation.  The  competent  authority  of  the  place  of  destination  must  take  the  appropriate  measures.

5.(cid:217)Slaughter  of  eligible  animals  must  take  place  in  slaughterhouses,  exclusively  used  for  slaughter  of

animals  under  a  Date(cid:220)based  Scheme  or  under  a  Certified  Animal  Scheme.

6.(cid:217)The  competent  authority  must  ensure  that  procedures  used  in  the  cutting  plants  ensure  that  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.

7.(cid:217)Meat  must  be  traceable  back  to  the  herd  of  the  eligible  animal,  or  after  cutting,  to  the  animals  cut
in  the  same  batch,  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  Part  I  back  to
the  herd  to  enable  the  consignment  concerned  to  be  recalled.  In  case  of  petfood  accompanying
documents  and  records  must  enable  tracing.

8.(cid:217)All  approved  eligible  carcasses  must  have  individual  numbers  correlated  with  the  eartag  number.

9.(cid:217)The  Member  State  must  have  detailed  protocols  in  place  covering:

(a)(cid:217)tracing  and  controls  prior  to  slaughter;

(b) controls  during  slaughter;

(c) processing  of  petfood;

(d) all  labelling  and  certification  requirements  after  slaughter  to  the  point  of  sale.

10.(cid:217)The  competent  authority  must  set  up  a  system  for  recording  checks  on  compliance  so  that  control

can  be  demonstrated.

The  establishment

11.(cid:217)To  obtain  approval,  the  establishment  must  devise  and  implement  a  system  whereby  the  eligible
meat  and/or  eligible  product  is  identifiable  and  all  meat  can  be  traced  back  to  its  herds  of  origin,
or  after  cutting,  to  the  animals  cut  in  the  same  batch.  The  system  must  facilitate  full  traceability  of
the  meat  or  products  of  animal  origin  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  of  the
establishment  to  the  competent  authority.

12.(cid:217)The  competent  authority  must  assess,  approve  and  monitor  the  system  provided  by  the  estab(cid:220)
lishment  in  order  to  ensure  that  it  provides  full  segregation  and  traceability  both  backwards  and
forwards.

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19.2.1999

CHAPTER  B

Import  into  the  Community  of  products  of  animal  origin

I.(cid:217)Import  into  the  Community  from  countries  or  regions  thereof,  placed  in  Category  4  of  the  products  of
animal  origin  referred  to  in  Article  16(3)  shall  be  prohibited  if  they  contain  or  are  derived  from  the
following  products  or  material  derived  from  ruminant  animals:

-(cid:217)mechanically  separated  meat;

-(cid:217)dicalcium  phosphate  destined  for  feeding  farmed  species;

-(cid:217)gelatine  unless  produced  from  hides;

-(cid:217)rendered  ruminant  fat  derivatives;

-(cid:217)rendered  ruminant  fat  unless  produced  from  discrete  adipose  tissue,  which  itself  was  found  fit  for
human  consumption,  or  from  raw  material  which  has  been  processed  in  accordance  with  the
standards  laid  down  pursuant  to  Directive  90/667/EEC.

II.(cid:217)The  appropriate  certificates,  as  required  by  Community  legislation,  shall  be  supplemented  by  the

following  words:

"The  products  of  animal  origin  provide  guarantees  equivalent  to  those  of  Regulation  (EC)
No  .(cid:216).(cid:216)./.(cid:216).(cid:216).  of  the  European  Parliament  and  of  the  Council  and  originate  from  a  country,  or
region  within  a  country  in  BSE  Category  .(cid:216).(cid:216).(cid:216)(*).  This  category  was  established  by  Commission
Decision  .(cid:216).(cid:216)./.(cid:216).(cid:216)./EC(cid:216)(**);

(*)(cid:217)Complete  as  appropriate  with  1,  2,  3  or  4.
(**)(cid:217)Complete.’

When  importing  from  third  countries  or  regions  thereof  which  are  not  placed  in  Category  1,  the  appro(cid:220)
priate  certificates,  as  required  by  Community  legislation,  shall  be  supplemented  by  declaration  signed  by
the  competent  authority  of  the  country  of  production,  worded  as  follows:

"The  product  does  not  contain,  and  is  not  derived  from,  specified  risk  material  as  defined  in  Regu(cid:220)
lation  (EC)  No  .(cid:216).(cid:216)./.(cid:216).(cid:216).  of  the  European  Parliament  and  of  the  Council.  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(cid:220)shaped
instrument  introduced  into  the  cranial  cavity’

or

"The  product  contains,  or  is  derived  from,  material  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  .(cid:216).(cid:216)./.(cid:216).(cid:216)./EC’.

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ANNEX  X

REFERENCE  LABORATORIES,  SAMPLING  AND  LABORATORY  METHODS

CHAPTER  A

National  reference  laboratories

1.(cid:217)The  designated  national  reference  laboratory  shall:

(a)(cid:217)have  at  its  disposal  facilities  and  expert  personnel  enabling  it  to  show  at  all  times,  and  especially
when  the  disease  in  question  first  appears  the  type  and  strain  of  the  agent  of  TSEs,  and  to  confirm
results  obtained  by  regional  diagnostic  laboratories.  Where  it  is  not  capable  of  identifying  the
strain(cid:220)type  of  the  agent,  it  shall  set  up  a  procedure  to  ensure  that  the  identification  of  the  strain  is
referred  to  the  Community  reference  laboratory;

(b) verify  diagnostic  methods  used  in  regional  diagnostic  laboratories;

(c) be  responsible  for  coordination  of  diagnostic  standards  and  methods  within  the  Member  State.  To

this  end,  it:

-(cid:217)may  provide  diagnostic  reagents  to  laboratories  approved  by  the  Member  State;

-(cid:217)shall  control  the  quality  of  all  diagnostic  reagents  used  in  the  Member  State;

-(cid:217)shall  periodically  arrange  comparative  tests;

-(cid:217)shall  hold  isolates,  or  corresponding  tissues,  of,  or  containing,  the  agents  of  the  disease  in

question  from  cases  confirmed  in  the  Member  State;

-(cid:217)shall  ensure  confirmation  of  results  obtained  in  diagnostic  laboratories  approved  by  the  Member

State.

(d) cooperate  with  the  Community  reference  laboratory.

2.(cid:217)However,  by  way  of  derogation  from  point  1,  Member  States  which  do  not  have  a  national  reference
laboratory  shall  use  the  services  of  the  Community  reference  laboratory  or  of  national  reference  labora(cid:220)
tories  in  other  Member  States.

3.(cid:217)The  national  reference  laboratories  are:

Austria:

Belgium:

Denmark:

Germany:

Finland:

France:

Greece:

Ireland:

Italy:

Luxembourg:

Netherlands:

Portugal:

Spain:

Sweden:

United  Kingdom:

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CHAPTER  B

Community  reference  laboratory

1.(cid:217)The  Community  reference  laboratory  for  TSEs  is:

2.(cid:217)The  functions  and  duties  of  the  Community  reference  laboratory  are:

(a)(cid:217)to  coordinate,  in  consultation  with  the  Commission,  the  methods  employed  in  the  Member  States

for  diagnosing  transmissible  spongiform  encephalopaties,  specifically  by:

-(cid:217)storing  and  supplying  corresponding  tissues  containing  the  agent,  for  the  development  or

production  of  the  relevant  diagnostic  tests,  typing  strains  of  the  agent;

-(cid:217)supplying  standard  sera  and  other  reference  reagents  to  the  national  reference  laboratories  in

order  to  standardize  the  tests  and  reagents  used  in  the  Member  States;

-(cid:217)building  up  and  retaining  a  collection  of  corresponding  tissues  containing  the  agents  and  strains

of  TSES;

-(cid:217)organizing  periodic  comparative  tests  of  diagnostic  procedures  at  Community  level;

-(cid:217)collecting  and  collating  data  and  information  on  the  methods  of  diagnosis  used  and  the  results

of  tests  carried  out  in  the  Community;

-(cid:217)characterizing  isolates  of  the  TSE  agent  by  the  most  up(cid:220)to(cid:220)date  methods  to  allow  greater  under(cid:220)

standing  of  the  epidemiology  of  the  disease;

-(cid:217)keeping  abreast  of  the  developments  in  the  surveillance,  epidemiology  and  prevention  of  TSEs

throughout  the  world;

-(cid:217)retaining  expertise  on  prion  diseases  to  enable  rapid  differential  diagnosis;

-(cid:217)acquiring  a  thorough  knowledge  of  the  preparation  and  use  of  diagnostic  methods  used  to

control  and  eradicate  TSEs;

(b) to  assist  actively  in  the  diagnosis  of  outbreaks  of  TSEs  in  Member  States  by  receiving  samples  from
TSE  infected  animals  for  confirmatory  diagnosis,  characterization  and  epidemiological  studies;

(c) to  facilitate  the  training  or  retraining  of  experts  in  laboratory  diagnosis  with  a  view  to  the  harmon(cid:220)

ization  of  diagnostic  techniques  throughout  the  Community.

CHAPTER  C

Sampling  and  laboratory  methods

1.(cid:217)The  tests  performed  in  the  framework  of  the  monitoring  programme,  referred  to  in  Article  7,  shall
comprise  on  an  annual  basis,  a  range  of  tests,  including  at  least  histopathology  examination  of  brain
tissue,  immunocytochemical,  immunodiagnostic  tests  for  the  detection  of  scrapie  associated  fibrils
(SAFs)  and,  when  the  TSE  occurs  in  ovine  or  caprine  animals,  tests  to  identify  the  strain(cid:220)type  of  the
agent.

2.(cid:217)For  confirmation  of  the  suspected  presence  of  a  TSE,  pursuant  to  Article  12(2),  the  tests  performed
shall  at  least  comprise  histopathology  examination  of  brain  tissue.  The  competent  authority  may  also
require  the  use  of  other  laboratory  tests  such  as  immunocytochemical  and  immunodiagnostic  tests  for
the  detection  of  scrapie  associated  fibrils  (SAFs),  where  their  use  is  considered  appropriate.  In  case  of  a
first  appearance  of  the  disease  all  three  tests  should  be  performed.