Proposal for a Council Decision regulating the use of material presenting risks as regards transmissible spongiform encephalopathies and amending Commission Decisions 94/474/EC and 97/534/EC
Date: 1998-12-11
Institutions: European Commission
Subjects: animal disease, animal product, animal production, health risk, veterinary legislation

COMMISSION OF THE EUROPEAN  COMMUNITIES 

Brussels,  11.12.1998 
COM(1998) 749 final 

Proposal for a 
COUNCIL  DECISION 
regulating the use of material presenting risks as regards transmissible  spongiform 
encephalopathies and amending Commission Decisions 94/474/EC and 97/534/EC 

(presented by the  Commission) 

Hi 

EXPLANATORY  MEMORANDUM 

1.  The proposed  decision replaces and postpones  Commission  Decision  97/534/EC  laying 
down  the  rules  on  the  prohibition  of  the  use  of  material  presenting  risks  as  regards 
transmissible  spongiform  encephalopathies  (SRM).  It  respects  the  invitation  to  the 
Commission, of the Council of March  1998, to base an appropriate proposal  in the  field 
of SRMs on the OIE Code on BSE. 

It amends the provisions of 97/534/EC in respect of the following points: 

Cosmetic, medicinal and industrial products and medical devices are excluded  from 
the scope. 

The Decision allows Member  States and exporting third countries to remove  SRMs 
in  the 
light  of  their  geographical  risk.  The  following  procedure  applies: 
Member States  may  submit  the  data  necessary  to  allow  assessment  of  their 
geographical  BSE  risk  by  30  June  1999  at  the  latest.  Countries  which  have  not 
submitted  a dossier by this date will be placed  in a category  by the Commission  on 
the  basis  of  all  available  information.  The  data  of  countries  that  have  submitted  a 
dossier, will be assessed by the Scientific  Steering Committee. On the basis of their 
recommendation,  the  Commission  will  take  a  decision  after  consultation  of  the 
Member  States  (regulatory  committee  procedure).  Third  countries  will  also  be 
invited to submit the necessary data in the same time scale. 

The  list  of  SRM  is based  on  the  relevant  international  standard,  the  OIE  Code  on 
BSE,  and  its  currently  proposed  revision.  This  implies  an  enlargement 
in 
accordance  with  the  opinion  of  the  Scientific  Steering  Committee  (SSC)  of 
9 December  1997  in  areas  which  are  placed  in  Category  4,  i.e.  those  with  the 
highest  BSE risk.  On the basis  of the  lower  infectivity  levels  of  certain  tissues,  as 
listed in the opinion of the SSC of 27 March  1998, a choice was made not to require 
the removal in areas with a lower BSE risk of the tissues with the lowest  infectivity 
level and which were not recommended to be removed by the international  standard 
for  those  areas. This  list  will  apply  as from  1 October  1999, allowing  for  time  for 
the assessment  of the dossiers by the scientific  committees  and taking  into  account 
their  recommendations,  as  well  as  the  development  of  the  international  standard 
after  May  1999 and new scientific  advice. 

An  exemption  for  Member  States  applying  a  compulsory  single  carcass  test  for 
bovines  above  a certain age is introduced  in the Decision.  As  a precondition,  such 
tests must be approved by the Commission. A derogation for products derived  from 
tested carcasses to be imported from third countries is also  foreseen. 

2.  This proposed  decision  follows  the  advice  given  by the  SSC  on  9 December  1997 and 
on  27  March  1998  and  improves  consumer  safety  while  avoiding  unjustified  trade, 
economic  and  technical  conséquences.  In  addition,  it  allows  future  scientific  advice  to 
be taken into account and for respects WTO notification  requirements. 

3.  On  18 November  the  College  of  Commissioners  agreed  to  submit  the  proposal  to  the 
Standing  Veterinary  Committee  (SVC)  for  an  opinion.  On  26 November  the  proposal 
was  first  discussed  with  the  Member  States  in  a  working  group  of  the  SVC.  On 
2 December the proposal was presented for a vote to the SVC. The SVC gave a negative 
opinion.  Most  Member  States  objected  to  the  proposed  procedure  for  establishing  the 
TSE  status  of  countries,  which  requires  an  opinion  of  the  appropriate  scientific 
committee  and  will  be based  on an assessment  of the  incident, propagation  and  human 
exposure  risk.  In  proposing  the  classification  of  countries  the  Commission  will  base 
itself on the relevant  scientific  opinion taking the OIE Code on BSE into  consideration. 
Most  Member  States feel  that no clear criteria  are provided  for  in this text. In  addition, 
most  Member  States  object  to  the  complexity  of  the  ensuing  control  system  resulting 
from  different  lists  of  SRMs  applicable  in  countries  classified  according  to  four 
categories of TSE status. Finally, several technical remarks were made. 

The results of the vote were: 

Against:  B, DK, DE, GR, FR, IRL, IT, L, P, FIN 

Abstain:  NL, AUS, SW, UK 

No vote:  SP (because of the absence of Spanish interpretation). 

Proposal for a 
COUNCIL  DECISION 
regulating the use of material presenting risks as regards transmissible  spongiform 
encephalopathies and amending Commission Decisions 94/474/EC and 97/534/EC 

(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, 

Having  regard  to  Council  Directive  89/662/EEC of  11 December  1989 concerning  veterinary 
checks in intra-Community  trade with a view to the completion  of the internal market1,  as last 
amended by Directive 92/118/EEC2, and in particular Article 9(4) thereof, 

Having  regard  to  Council  Directive  90/425/EEC  of  26  June  1990  concerning  veterinary  and 
zootechnical  checks  applicable  in  intra-Community  trade  in certain  live  animals  and  products 
with a view to the completion of the internal market3, as last amended by Directive 92/118/EEC, 
and in particular Article  10(4) thereof, 

Having  regard  to  Council  Directive  90/675/EEC  of  10  December  1990  laying  down 
the  principles  governing 
the  organisation  of  veterinary  checks  on  products  entering 
the Community from third countries4, as last amended by Directive 96/43/EC5, and in particular 
Article  19 thereof, 

Having regard to the proposal from the Commission6, 

(1)  Whereas  pursuant 

to  Directive  89/662/EEC  and  Directive  90/425/EEC, 

the 
Member  State  of  origin  or  dispatch  is  required  to  implement  on  its  territory  the 
appropriate  measures  to  prevent  all  situations  likely  to  constitute  a  serious  hazard  to 
animals or to human health; 

(2)  Whereas several distinct transmissible  spongiform  encephalopathies (TSEs) have been 
recognised for many years to occur separately in humans and animals; whereas  bovine 
spongiform  encephalopathy  (BSE) was first  recognised  in bovine animals in  1986 and 
in  following  years  was  recognised  to  occur  in  other  species  of  animals;  whereas  a 
in  1996; 
new  variant  of  Creutzfeldt-Jakob  Disease  (nv-CJD)  was  described 
whereas evidence  is  accumulating  that  the  agent  causing  BSE  is  identical  to  that 
causing nv-CJD; 

OJL 395, 30.12.1989, p. 13. 
OJL 62, 15.3.1993, p. 49. 
OJL224,  18.8.1990, p. 29. 
OJ L 373, 31.12.1990, p. 1. 
OJL  162, 1.7.1996, p. 1. 
OJC 

(3)  Whereas  rules  should  be  laid  down  concerning  the  production  and  placing  on  the 
market  of  live  animals  and  products  of  animal  origin  with  respect  to  removal  of,  or 
absence of,  specified  risk material on the basis of the risk classification  of the country 
or  region  concerned;  whereas,  however,  those  rules  should  not  apply  to  cosmetic  or 
medicinal  products  or  medical  devices,  or  their  starting  materials  or  intermediate 
products,  for  which other  specific  rules  apply;  whereas they  should  also not  apply  to 
products  of  animal  origin  which  do  not  pose  a  risk  to  animal  or human  health  since 
they  are  intended  for  purposes  other  than  human  food,  animal  feed  or  fertiliser; 
whereas  it  is  appropriate  to  ensure  that  products  of  animal  origin  excluded  from  the 
scope  of this Decision  are kept  separate  from  those  covered  by it unless they  meet  at 
least the same health standards as the latter; 

(4)  Whereas  existing  Community  Directives provide  for  the protection  of public  health  in 
respect  of  the  use  of  specified  risk  material  in  cosmetic  or  medicinal  products  and 
medical  devices  placed  on  the  market  in  the  Community;  whereas,  therefore,  those 
products may be excluded from the scope of this Decision; 

(5)  Whereas  a  procedure  should  be  established 

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; 

the  determination  of 

for 

(6)  Whereas  at  its  general  assembly  in  Paris  on  29  May  1998,  the  Office  International 
des  Epizooties  (OIE)  adopted  a  revised  version  of  its  Animal  Health  Code  on  BSE 
(OIE Code  on  BSE); whereas  Article  3.2.13.14  of that  Code  recommends  that  bovine 
brain,  eyes,  spinal  cord,  tonsils,  thymus,  spleen,  intestines,  dorsal  root  ganglia, 
trigeminal  ganglia and bones, and protein products derived from them  from  cattle over 
six months of age originating from countries with a high incidence of BSE should not be 
traded between countries; whereas the same Article recommends that bovine brain, eyes, 
spinal  cord  and  distal  ileum  and  protein  products  derived from them  from  cattle  over 
six months  of  age  originating  from  countries  with  a  low  incidence  of  BSE  and  born 
before  the  feedban  was  effectively  enforced,  should  not  be  traded  between  countries; 
whereas it further  recommends that brains and spinal cord (list under study) and protein 
products derived therefrom, from cattle, originating from a country or zone that has not 
demonstrated  a  BSE  free  status  and  has  not  declared  any  indigenous  cases  of  the 
disease,  which  were  born  before  the  date  from  which  the  ban  on  the  feeding  of 
ruminants  with  meat-and-bone  meal  derived  from  ruminants  was  effectively  enforced, 
and which were at the time of slaughter  aged  over  30 months (under study) should not 
be traded between countries; 

(7)  Whereas  the  Code  Commission  of  the  OIE,  following  recommendations  of  the 
scientific  Ad  Hoc  Group  on  BSE  epidemiology,  issued  proposed  amendments  to  the 
OIE Code on BSE in September  1998; whereas the effect  of those amendments would 
be  to  require  that  those  tissues,  instead  of  not  being  traded,  should  not  be  used  for 
the  preparation  of  human  food,  animal 
feed,  cosmetics,  pharmaceuticals  or 
medical devices; 

(8)  Whereas  the  Scientific  Veterinary  Committee  in  its  opinion  of  21  October  1996, 
recommended on the basis of its risk assessment that specified  risk materials, defined  as 
brain, spinal cord and eyes from cattle, sheep and goats over one year of age and spleens 
from  sheep and goats over six months of age, should be removed from all human  food 
and animal feed  chains in countries or regions where a potential risk was identified,  and 
that,  in  the  case  of  fallen  bovine  animals,  sheep  and  goats,  either  the  specified  risk 
materials  should be removed  so that they  do not  enter any human  food  or animal  feed 
chain, or the whole carcase should be destroyed; 

(9)  Whereas 

the  Scientific  Steering  Committee 

(SSC)  adopted  an  opinion  on 
9 December  1997;  whereas  in  that  opinion  the  SSC  suggested  a  new  and  enlarged 
list  of  specified  risk  materials  and  proposed  that  those  materials  should  be 
excluded  temporarily  from  human  and  animal  consumption  depending  on  the 
geographical  source; 

(10)  Whereas  on  the  basis  of  the  advice  of  the  Scientific  Veterinary  Committee  of 
21 October  1996, in accordance with the risk assessment carried out by that Committee, 
the Commission adopted Decision 97/534/EC of 30 July  1997 on the prohibition of the 
use of material presenting risks as regards transmissible  spongiform  encephalopathies7; 
as  last  amended  by  Council  Decision  98/248/EC8;  whereas  in  the  light  of  the  new 
scientific  advice  and  the  development  of  international  standards  the  list  of  specified 
risk materials laid down in Decision 97/534/EC is no longer appropriate; 

(11)  Whereas  certain  ruminant  tissues  should  be  designated  as specified  risk  materials  on 
the basis of the pathogenesis of TSEs and the epidemiological  status of the country  or 
region  of  origin  or  residence  of  the  animal  concerned;  whereas  the  specified  risk 
materials  should  be  removed  and  disposed  of  in  a  manner  which  avoids  any  risk  to 
human  or  animal  health;  whereas,  in  particular,  they  should  not  be  placed  on  the 
market  for  human food,  animal feed  or fertiliser;  whereas, however,  provision  should 
be made for  an equivalent  level of health protection to be achieved by means of a test 
for TSEs carried out on individual  animals; whereas slaughter techniques presenting a 
risk  of causing  brain material  to contaminate  other tissues  should  not be permitted  in 
countries  or regions  other than those presenting  the  lowest  risk  of BSE; whereas it is 
necessary for practical and precautionary reasons to exclude the use of distal ileum and 
spleens  from  sheep  and  goats  and,  as appropriate,  bovine  animals,  irrespective  of age, 
and  mechanically  recovered  meat  from  the  skull  and  vertebral  column  of  bovine 
animals, sheep and goats; 

(12)  Whereas  equivalent  guarantees  should  be  required  for  imports  from  third  countries; 
whereas  the  situation  as  regards  TSEs  may  vary  between  countries  and  the  import 
requirements  should  therefore  be  adapted  to  the  particular  situation  of  the  country 
of origin; 

7  OJL216,  8.8.1997, p. 95. 
8  OJL  102, 2.4.1998, p. 26. 

(13)  Whereas  Commission  Decision  94/474/EC  of  27  July  1994  concerning  certain 
protection  measures  relating  to  bovine  spongiform  encephalopathy  and  repealing 
Decisions  89/469/EEC  and  90/200/EEC9,  as  last  amended  by  Decision  98/272/EEC10, 
and Decision 97/534/EC should be amended accordingly; 

(14)  Whereas this Decision should be reviewed in the light of new scientific information  with 
regard  to  risk  of  exposure  to  TSEs  resulting  from  infectivity  in  animal  species,  age 
categories, tissues or materials not yet covered by this Decision; 

(15)  Whereas  the  measures  provided  for  in  this  Decision  are  not  in  accordance  with  the 
opinion of the Standing Veterinary  Committee; whereas they must therefore  be adopted 
by the Council, 

HAS ADOPTED THIS DECISION: 

Article 1 
Scope 

1. 

This  Decision  regulates  the  use  of  material  presenting  risks  as  regards  certain 
transmissible  spongiform  encephalopathies  (TSEs). It shall apply to the production  and 
placing on the market of live animals and products of animal origin. 

2. 

This Decision shall not apply to: 

(a) 

(b) 

(c) 

cosmetic  or medicinal  products  or medical  devices, together  with  their  starting 
materials or intermediate products; 

products  not  destined  for  use  in  human  food,  animal  feed  or  fertilisers, 
together with their starting materials or intermediate products; 

products  of  animal  origin  destined  for  exhibition,  teaching,  research,  special 
studies or analysis. 

3. 

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

Article  2 
Definitions 

For the purposes of this Decision, the following  definitions  shall apply: 

(1) 

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

9  OJL  194, 29.7.1994, p. 96. 
10  OJL  122, 24.4.1998, p. 59. 

(2) 

(3) 

(4) 

(5) 

placing  on the market: any  operation  the purpose  of which  is to supply  live  animals, 
or products of animal  origin  covered  by this Decision to a third party  for  sale, or  any 
other  form  of transfer  against  payment  or  free  of  charge  to  a third  party  and  storage 
with a view to supply to a third party, regardless of whether the operation  takes  place 
within  a  Member  State,  between  Member  States  or  from  a  third  country  to  a 
Member State; 

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

starting  materials:  raw  materials  or  any  other  product  of  animal  origin  out  of 
which, or  with  the  help  of  which,  the  products  referred  to  in  Article  l(2)(a)  and  (b) 
are produced; 

competent  authority:  the  central  authority  of  a  Member  State  competent  to  ensure 
compliance  with  the  requirements  of  this  Decision  or  any  authority  to  which  that 
central authority has delegated such competence; 

(6) 

categories: the categories set out in Annex I; 

(7) 

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

(8) 

skull: the bones of the head, including the bones of the lower jaw. 

Article  3 
Classification  for determination of BSE status 

1. 

2. 

3. 

4. 

Member  States and  third  countries,  or regions thereof,  shall  be placed  in  one  of  four 
categories in accordance with Annex I. 

Member  States  or  third  countries  shall  submit  an  application  to  the  Commission, 
accompanied  by  the  information  laid  down  in  Annex  II  for  their  BSE  status  to 
be determined. 

The Commission,  acting  in accordance  with the procedure  laid down  in Article  17 of 
Directive  89/662/EEC, shall take a decision in respect of each application to place the 
applicant Member State or third country, or region thereof, in one of four  categories. 

The  Commission  shall take  its decision  within  six months after  the submission  of the 
application.  If  the  Commission  finds  that  the  application  does  not  include  all  the 
information  laid  down  in  Annex  II,  it  shall  ask  for  additional  information  within  a 
delay  to  be  specified.  The  final  decision  shall  then  be  taken  within  six  months  after 
submission of the complete  information. 

Member  States  or  third  countries  which  have  not  submitted  an  application  in 
accordance  with  paragraph  2  within  six  months  after  the  date  referred  to  in  the 
first paragraph  of Article  11 shall  be placed  in  a category  by the  Commission  on  the 
basis of all information  available to the Commission. 

5. 

6. 

1. 

2. 

3. 

4. 

5. 

Member  States  shall communicate  any  changes  in the circumstances  relevant to  their 
BSE  status  to  the  Commission  without  delay.  The  eligibility  of  third  countries  to 
export  to  the  Community  live  animals  or  products  of  animal  origin,  for  which  this 
Decision  provides  specific  rules,  shall  be  conditional  upon  their  undertaking  in 
writing to communicate any changes in the circumstances relevant to their BSE status 
to the Commission without delay. 

The decisions referred  to in paragraphs 3 and 4 shall be taken after  consultation of the 
appropriate  scientific  committee  and  shall be based  on an assessment  of the  incident, 
propagation and human exposure risk, taking into consideration the  recommendations 
oftheOIECodeonBSE. 

Article  4 
Specified  risk material 

Member  States shall ensure that  after  30  September  1999 the  specified  risk  materials 
are,  under  the  direct  supervision  of  an  official  of  the  competent  authority,  removed 
from  animals which were slaughtered  or which died on their territory  and disposed  of 
in accordance with Annex III. They shall not be placed on the market for human  food, 
animal feed or fertilisers after 30 September 1999. 

Paragraph  1  shall not apply where animals have been subjected to a test which has been 
approved by the Commission in accordance with the procedure laid down in Article  17 
of Directive 89/662/EEC, applied under the conditions laid down in Annex III, point 8, 
and the results of that test were negative. 

In  Member  States,  or  regions  thereof,  which  are  not  placed  in  Category  1,  the 
following  slaughter techniques  shall not  be used  on bovine, ovine or caprine  animals 
whose meat is destined for human or animal  consumption: 

(a) 

stunning or killing by means of a gas injected  into the cranial cavity; 

(b) 

laceration  after  stunning  of  central  nervous  tissue  by  means  of  an  elongated 
rod-shaped instrument introduced into the cranial cavity. 

The use of the skull and vertebral column of bovine, ovine and caprine animals for  the 
production of mechanically recovered meat in Member  States, or regions thereof which 
are not placed in Category  1 shall be prohibited after  30 September  1999. This shall not 
apply  to  animals  which  will  are  subjected  to  a  test  in  accordance  with  Annex  III, 
point 8. 

By  way  of  derogation  from  paragraph  1 the  Commission,  acting  in  accordance  with 
the procedure  laid down  in Article  17 of  Directive  89/662/EEC, may  take a  decision 
in  respect  of  the  date  of  effective  enforcement  of  the  prohibition  on  the  feeding  of 
mammalian  protein  to  ruminants  in  each  Member  State  or  region  thereof  placed  in 
Category  2 or  3, and  allow the  application  of paragraph  1 to  be  confined  to  animals 
which were born before that date in those countries or those regions. 

Article 5 
Placing on the market 

1. 

2. 

Where  bovine,  ovine  or  caprine  animals  coming  from  countries,  or  regions  thereof, 
placed  in one category  are to be  slaughtered  after  30  September  1999 in the  territory 
of Member States in a lower category, paragraphs 2, 3 and 4 shall apply. 

The  Member  State  of  destination  shall  ensure  that  the  specified  risk  materials  are 
removed from the animals referred to in paragraph  1 and destroyed in accordance with 
Article  4.  Those  animals  shall  be  slaughtered  in  slaughterhouses  approved  for  that 
purpose by the competent authority and at the end of the normal slaughtering process. 

3. 

The Member State of dispatch shall ensure that: 

(a) 

for  bovine  animals,  the  animal  health  certificates  referred  to  in  Annex  F  to 
Council  Directive  64/432/EEC11  are  supplemented  by  the  following  words  to 
be entered in the section "Health data concerning bovine animals": 

"The BSE category of the animals listed below is Category  ...  (*); 

(*) 

Complete as appropriate with 1,2, 3 or 4."; 

(b) 

for  ovine  or  caprine  animals  the  animal  health  certificates  corresponding  to 
Model III in Annex E to Council Directive 91/68/EEC12 shall be  supplemented 
by the following  words to be entered in section V "Health  information": 

"BSE category of the animals listed below: Category  ...  (*); 

(*) 

Complete as appropriate with  1, 2, 3 or 4."; 

(c) 

for  all animals, the competent  authority  of the Member  State of destination  is 
informed  of the BSE category of the animals in each consignment by means of 
a specifically  coded ANIMO message or by fax. 

4. 

The third country of dispatch shall ensure that: 

(a) 

for bovine, ovine and caprine animals the appropriate certificates, as required by 
Community legislation, are supplemented by the following words: 

"The BSE category of the animals listed below is Category  ...  (*). 

(*) 

Complete as appropriate with 1,2, 3 or 4."; 

(b) 

the competent  authority  of the Member  State of destination  is informed  of the 
BSE  category  of the  animals  in  each  consignment  by  means  of  a  specifically 
coded ANIMO message or by fax. 

"  OJ L  121, 29.7.1964, p. 1977/64. 
12  OJL 46,  19.2.1991, p. 19. 

10 

Products  listed  in  Annex  IV  which  contain  material  derived  from  bovine,  ovine  or 
caprine animals and are imported into the Community after  30 September  1999 shall be 
accompanied  by  the  appropriate  certificate,  as  required  by  Community  legislation, 
supplemented by the following words: 

in 
"The  products  originate 
BSE category...  (*).  This  category  was  established  by  Commission  Decision 
[.../...](**). 

region  within  a  country 

from  a  country,  or 

(*) 

Complete as appropriate with 1,2, 3 or 4 

(**)  Complete". 

Where  those  products  are  imported  from  third  countries,  or  regions  thereof,  in 
Categories  3 and 4 or from third  countries, or regions thereof,  in  Category  2 in  which 
BSE  has  occurred,  the  appropriate  certificates,  as  required  by  Community  legislation, 
shall  be  supplemented  by  one  of  the  following  declarations  signed  by  the  competent 
authority of the country of production: 

"The  product  does  not  contain,  and  is  not  derived  from,  specified  risk  material  as 
defined  in  Decision  [.../...],  produced  after  30  September  1999,  or  mechanically 
recovered  meat obtained from  the skull or vertebral column of bovine, ovine or caprine 
animals, produced  after  30 September  1999. The animals have not been slaughtered by 
stunning or killing by means of a gas injected  into the cranial cavity, or slaughtered by 
laceration  after  stunning  of  central  nervous  tissue  by  means  of  an  elongated 
rod-shaped instrument introduced into the cranial cavity" 

or, 

"The product contains, or is derived from, material produced after  30 September  1999 of 
bovine,  or  as  appropriate,  ovine  or  caprine  animals  which  were  tested  and  found 
negative  for  the presence  of BSE using  a test which was  approved  in  accordance  with 
Commission Decision [.../...]". 

Any  reference  to  "products"  in  this  Article  is  a  reference  to  the  products  listed  in 
Annex IV, not to other products containing or derived from those products. 

By  way  of  derogation  from  paragraph  5, the  Commission  acting  in  accordance  with 
the procedure  laid  down  in Article  17 of  Directive  89/662/EEC, may  take  a  decision 
in  respect  of  the  date  of  effective  enforcement  of  a  prohibition  on  the  feeding  of 
mammalian protein to ruminants in any third country, or region thereof, in Category 2 
or  3,  and  allow  the  application  of  paragraph  5  to  be  confined  to  specified  risk 
materials derived from  animals which were born before that date in those countries or 
those regions. 

11 

Article  6 
Official  controls 

1. 

Member States shall carry out frequent official  controls to verify  the correct  application 
of this Decision and ensure that measures are taken to avoid contamination,  particularly 
in slaughterhouses, cutting plants, animal waste processing plants, high risk  processing 
plants  or premises  authorised  by  the  Member  States  in  accordance  with  Article  7  of 
Council Directive 90/667/EEC13, points of sale to the consumer and storage facilities. 

2. 

Member States shall in particular set up a system to ensure and check that: 

(a) 

(b) 

specified  risk  materials  used  for  products  referred  to  in  Article  1(2)  are 
exclusively used for the authorised purpose; 

where  live  bovine,  ovine  or  caprine  animals  are  received  by  Member  States 
placed  in a lower  BSE category  than that of the animals, those animals  remain 
under official  supervision until slaughter or dispatch from their territory. 

Article 7 
Further precautionary measures 

Member  States  may  take  precautionary  measures  going  beyond  the  measures  provided  for  in 
this Decision in relation to animals slaughtered on their own territory. 

Article 8 
Other acts 

This  Decision  shall  be  without  prejudice  to  the  provisions  of  Council  Decision  98/256/EC14, 
Decision 94/474/EEC and Commission Decision 98/653/EC15. 

Article 9 
Amendments 

1. 

Article 3(3) of Decision 94/474/EEC is hereby amended as follows: 

(a) 

Point (a) is deleted; 

(b) 

In point  (c), the words  "scientific  tests  are used to monitor  the  implementation 
of (a)  and  (b)"  are  replaced  by  "scientific  tests  are  used  to  monitor  the 
implementation of (b)". 

13  OJL  363, 27.12.1990, p. 51. 
14  OJL  113, 15.4.1998, p. 33. 
15  OJL311,20.11.1998,p.23. 

12 

2. 

Article  10 of Decision 97/534/EC is replaced by the  following: 

"Article 10 

This  Decision  shall  apply  from  such  time  as  the  Commission,  acting  in  accordance 
with the procedure laid down in Article  17 of Directive 89/662/EEC, shall determine". 

Article  10 
Review 

This Decision and the Decisions referred  to in Article 3 shall be reviewed regularly in the light 
of  new  epidemiological  information  and  scientific  information  with  regard  to  criteria 
determining  the  level  of  risk  in  regions,  and  the  risk  of  exposure  to  TSEs  resulting  from 
infectivity  in  other  animal  species,  age  categories,  tissues  or  materials.  Where  necessary  this 
Decision  shall  be  amended  after  consultation  of  the  appropriate  Scientific  Committee  and  in 
accordance with the procedure laid down in Article  17 of Directive 89/662/EEC. 

Article  11 
Application 

This Decision shall apply from 1  January 1999. 

It  does not  apply  to  products  which  were produced  before  1 October  1999 referred  to  in  this 
Decision, containing or derived from specified risk materials. 

Article  12 
Addressees 

This Decision is addressed to the Member States. 

Done at Brussels, 

For the Council 
The President 

13 

ANNEXI 

CLASSIFICATION 

I. 

For the purpose of determining the BSE status of Member  States or third countries, 
or  regions  within  Member  States  or  third  countries,  the  following  categories 
are established: 

A.  MEMBER STATES 

Category 1 (BSE free) 

Category 2 (provisionally BSE free) 

Category 3 (low BSE risk) 

Category 4 (high BSE risk) 

B. 

THIRD COUNTRIES 

Category 1 (BSE free) 

Category 2 (provisionally BSE free) 

Category 3 (low BSE risk) 

Category 4 (high BSE risk) 

II.  Where an animal moves from one category of a country or region to another, it shall 
acquire or retain the highest numerical BSE category of any country or region in which 
it has been kept for more than 24 hours, unless adequate guarantees can be provided that 
the  animals  were  not  fed  with  feed  from  that  country  or  region  with  the  highest 
numerical BSE category. 

14 

ANNEX II 

Information  to be submitted in support of an application for recognition of risk 
classification  under Article 3 

All data must be provided  on an annual basis and preferably  from  1980 onwards, but at least 
from  1988. 

to  provide  comprehensive  and  consistent 
Applicant  States  must  make  every  effort 
information.  Data  which  are  not  provided  or  are  incomplete  or  are  considered  as 
unsatisfactory  may be completed by reference to other sources of information  available to the 
Commission,  or  may  have  to  be  replaced  by  a worst-case  assumption  for  the  purposes  of  a 
risk assessment. 

Information  must be provided on: 

1. 

Structure and dynamics of the bovine, ovine and caprine animal  populations 

(a) 

absolute numbers of animals per species and breed, alive and at time of slaughter; 

(b) 

age distributions of animals per species and breed, sex and type; 

(c) 

age distribution of animals per species and breed, sex and type at time of slaughter; 

(d) 

geographical distribution of the animals by species and breeds; 

(e) 

(f) 

geographical  distribution  of  the  animals  by  husbandry  systems,  herd  sizes  and 
production purposes; 

system  of identification  and capacities  for  tracing  of animals  and  a system  of  control 
and  possible  sanctions  in  accordance  with  Community 
legislation  on  animal 
identification  and registration. 

2. 

Animal trade 

(a) 

imports and exports; 

(b) 

trade within the geographical area; 

(c) 

imports of embryos and semen; 

(d) 

use made of imported animals, embryos or semen; 

(e) 

mechanisms  used by  slaughterhouses  to identify  animals  and their  origins, as well  as 
data from these procedures. 

15 

3. 

>  Animal feed 

(a) 

(b) 

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

imports  of  MBM,  specifying  country  of  origin,  and  its  use  per  species  and 
husbandry system  (in  particularly  the  proportion  of  that  MBM  fed  to  bovine,  ovine 
and caprine animals); 

(c) 

exported MBM, specifying  country of destination. 

4. 

Meat and bone meal (MBM) bans 

(a) 

complete  description; 

(b) 

dates of introduction; 

(c) 

actual implementation, policing and compliance  figures; 

(d) 

possibilities of cross-contamination  with other feed. 

5. 

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

(a) 

complete description; 

(b) 

dates of introduction; 

(c) 

actual implementation, policing and compliance  figures. 

6. 

Surveillance of TSE, with particular reference to BSE and scrapie 

(a) 

incidence of laboratory confirmed  cases of BSE and scrapie; 

(b) 

age distribution, geographical distribution, and countries of origin of cases; 

(c) 

(d) 

incidence  of  neurological  disorders  in  which  TSE  could  not  be  excluded  on  clinical 
grounds in any animal species; 

methodologies and programmes of surveillance and recording of clinical cases of BSE 
and  scrapie,  including  awareness  training  for  farmers,  veterinarians,  supervisory 
bodies and authorities; 

(e) 

incentives for reporting cases, compensation and reward schemes; 

(f) 

methodologies  of  laboratory  confirmation  and  recording  of  suspect  cases  of  BSE 
and scrapie; 

16 

(g) 

strains of BSE and scrapie agents possibly involved; 

(h) 

existing systems or current plans for targeted active surveillance. 

7. 

Rendering and feed processing 

(a) 

all rendering and feed processing systems used; 

(b) 

nature of the records of rendering and processing plants; 

(c) 

quantitative and qualitative parameters of MBM and rendered  animal fat  production 
by each of the processing systems; 

(d) 

the geographical areas from which the rendered materials originate; 

(e) 

the type of raw material used; 

(f) 

parameters  on  separate  processing 
suspected animals; 

lines  for  materials  from  healthy  and 

(g) 

transport and storage systems for MBM or feed containing MBM. 

8. 

BSE or scrapie related culling 

(a) 

culling criteria; 

(b) 

date of introduction of the culling scheme and of any subsequent modification; 

(c) 

animals culled (details as specified in point 1); 

(d) 

sizes of herds in which animals were culled. 

17 

ANNEX III 

SPECIFIED RISK MATERIAL 

The  following  tissues shall  be designated  as  specified  risk  materials  depending  on  the 
category  of the country  of origin or residence  of the animal, determined  in  accordance 
with Article 3: 

CATEGORY 1 

No tissues are designated as specified  risk materials. 

CATEGORY2 

In countries, or regions within countries, placed in Category 2, the following  are only 
designated as specified  risk materials where BSE has occurred16: 

(a) 

the brain and spinal cord  of: 

bovine animals aged over 30 months, 

ovine  and  caprine  animals  which  are  aged  over  12  months  or  have  a 
permanent incisor erupted through the gum; 

(b) 

the distal ileum and spleen of ovine and caprine animals of all ages. 

CATEGORY3 

i 

(a) 

the  entire  head  excluding  the  tongue,  including  the  brain  and  dura  mater, 
pituitary  gland,  eyes, trigeminal  ganglia  and  tonsils; the  spinal  cord  and  dura 
mater  of  bovine  animals  aged  over  six  months  and  of  ovine  and  caprine 
animals aged over  12 months; 

(b) 

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

CATEGORY4 

(a) 

the  entire  head  excluding  the  tongue,  including  the  brain  and  dura  mater, 
pituitary  gland, eyes, trigeminal  ganglia and tonsils; the thymus; the  intestines 
from  the duodenum to the rectum; the vertebral  column,  including  dorsal  root 
ganglia,  unless  specific  measures  have  been  taken  covering  meat-and-bone 
meal  and  maternal  transmission  and  in  the  light  of  the  latest  available 
scientific  advice;  spinal  cord  and  dura  mater  of  bovine  animals  aged  over 
six months and of ovine and caprine animals aged over  12 months; 

pending OIE  confirmation. 

18 

(b) 

other bones of bo vine animals aged over 30 months; 

(c) 

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

Pursuant to a Decision in respect of the date of effective  enforcement  of a prohibition 
on the feeding  of mammalian protein to ruminants in each country, or region of within 
a  country,  placed  in  Category  2  or  3,  as  referred  to  in  Articles  4(5)  and  5(6),  the 
application  of  the  provisions  related  to  specified  risk  materials  may  be  confined  to 
those  derived  from  animals  which  were  born  before  that  date  in  those  countries  or 
those regions. 

Member  States  shall  ensure 
at slaughterhouses. 

that 

the  specified 

risk  materials  are 

removed 

However,  in  Member  States  or  regions  within  Member  States  that  are  not  placed  in 
Category  4,  the  removal  and  subsequent  destruction  according  to  point  5  of  specified 
risk materials from raw material for the production of rendered ruminant  fat  derivatives 
is not required provided that the derivatives are produced in accordance with Annex V. 

By way of derogation from point 3, Member States may allow the removal  of: 

(a) 

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

(b) 

the  vertebral  column  or  bones  at  the  point  of  sale  to  the  consumer  on 
their territory. 

Member  States  shall  set  up  a  system  to  ensure  and  check  that,  where  the  removal  of 
specified  risk materials takes place  at establishments  other than  slaughterhouses,  those 
materials are completely  separated  from  other waste, are  collected  separately  and  are 
disposed of in accordance with point 5. 

Member  States  shall  ensure  that  specified  risk  material  is  stained  with  a  dye 
immediately on removal, and that all specified risk material is completely destroyed: 

(a) 

by direct incineration; or, 

(b) 

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

(i) 

incineration; 

(ii) 

burning as fuel; or, 

(iii) 

another method, which precludes all risk of transmission of a TSE, and is 
authorized and supervised by the competent authority. 

19 

Where  bovine, ovine  or  caprine  animals  have  died  or have been killed  in the  context 
of disease control measures, Member  States may allow disposal  of the entire body  of 
those animals without removal of the specified  risk materials. 

Member States may derogate from the provisions of points 3 and 5 to allow the burning 
or  burial  of  specified  risk  material  or  entire  bodies,  without  prior  staining,  or,  as 
appropriate,  removal  of  the  specified  risk  materials,  in  the  circumstances  set  out  in 
Directive 90/667/EEC. 

The  application  of  a test  as  an  alternative  to  the  removal  of  specified  risk  materials 
may be authorised under the following  conditions: 

(a) 

(b) 

tests are carried  out in slaughterhouses  on all animals eligible  for  the  removal 
of specified  risk materials; 

no  bovine,  ovine  or  caprine  product  intended  for  human  food  or  animal  feed 
leaves  the  slaughterhouse  before  the  results  of  the  tests  on  all  slaughtered 
animals  produced  in  the  same  batch  have  been  received  and  accepted  by  the 
competent authority; 

(c) 

when a post-slaughter test gives a positive result, all bovine, ovine and  caprine 
material produced in the same batch is destroyed in accordance with point 5. 

Member States shall carry out frequent  official  controls, particularly in slaughterhouses, 
cutting plants, animal waste processing plants, high risk processing  plants  or  premises 
referred  to  in  Article  7 of  Directive  90/667/EEC,  points  of  sale to the  consumer  and 
storage facilities, and shall ensure that measures are taken to avoid contamination. 

20 

ANNEX IV 

The products referred to in Article 5(5) are: 

(a) 

(b) 

(c) 

(d) 

(e) 

fresh  meat:  fresh  meat  as  defined  by  Council  Directive  64/43 3/EEC  on  health 
problems affecting intra-Community trade in fresh meat17; 

minced meat and meat preparations:  minced  meat  and meat preparations  as  defined 
by Council Directive 94/65/EC18; 

meat products  and other products of animal origin: meat products and other products 
of animal origin as defined by Council Directive 77/99/EEC19; 

milk products,  as defined  by  Council  Directive  92/46/EEC20,  which  are destined  for 
human consumption and containing gelatin or rendered animal fat; 

milk products,  as defined  by Council  Directive  92/118/EEC21, which are destined for 
animal consumption and containing gelatin or rendered animal fat; 

(f) 

fishery  products,  as defined  by  Council  Directive  91/493/EEC22,  which  are destined 

for human consumption and containing gelatin or rendered animal fat; 

(g) 

Ça) 

(i) 

(j) 

egg products,  as defined  by Council  Directive  89/437/EEC23, which are destined  for 
human consumption and containing gelatin or rendered animal fat; 

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

rendered fats,  as referred to by Council Directive 92/118/EEC; 

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

(k) 

petfood, as referred to by Council Directive 92/118/EEC; 

(1) 

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

(m) 

bones and bone products, as referred to by Council Directive 92/118/EEC; 

(n) 

raw  material  for 
Council Directive 92/118/EEC. 

the  manufacture  of  animal  feedingstujfs,  as  referred  to  by 

17  OJ 121,29.7.1964, p. 2012/64. Directive as last amended by Directive 95/23/EC (OJ L 243, 11.10.1995, 

P- 7). 

18  OJL 368, 31.12.1994, p. 10. 
19  OJL26, 31.1.1977, p. 85. 
20  OJ L 268,  14.9.1992, p. 1. 
21  OJL62,  15.3.1993, p.49. 
22  OJL268,24.9.1991, p. 15. 
23  OJL212, 22.7.1989, p. 87. 

21 

ANNEXV 

Tallow derivatives may be used for the production of human food,  animal  feed  or fertilisers 
provided  that  they  are  produced  by  an  appropriate,  validated  and  strictly  certified  method 
such as: 

1. 

Transesterification  or hydrolysis  at not less than 200°C  for not less than 20  minutes 
under pressure (glycerol, fatty acids and fatty acid esters production); or 

2. 

Saponification with NaOH 12 M (glycerol and soap production): 

in a batch process: at not less than 95°C for not less than three hours; or, 

in  a  continuous  process:  at  not  less  than  140°C,  2  bars  for  not  less  than 
eight minutes, or equivalent. 

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

22 

ISSN 0254-1475 

COM(98) 749 final 

DOCUMENTS 

EN 

03  05  02  10 

Catalogue  number  :  CB-CO-98-764-EN-C 

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