Proposal for a Council Decision on the prohibition of the use of material presenting risks as regards transmissible spongiform encephalopathies and repealing Decision 97/534/EC
Date: 1998-03-09
Institutions: European Commission
Subjects: animal disease, export, health risk, public health, veterinary inspection

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 09.03.1998 
COM(1998) 160  final 

Proposal for a 

COUNCIL DECISION 

on the prohibition of the use of material presenting risks as regards transmissible 

spongiform encephalopathies and repealing Decision 97/534/EC 

(presented by the Commission) 

EXPLANATORY  MEMORANDUM 

1.  The decision replaces 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  amends  its  provisions  in  respect  of  the 

following  points : 

The  list  of  SRM  is  enlarged  in  accordance  with  the  opinion  of  the  Scientific 

Steering  Committee  (SSC) of 9 December  1997. This  list  will  apply  as from  1 July 

1998. 

The  Decision  allows  Member  States  and  Third  countries  with  regard  to  their 

exports to the Community  to ask  for a total  or partial  derogation  from  the SRM ban 

in the light of their geographical  risk. The following  procedure applies : 

Member  States  requesting  a  derogation  must  submit  the  data  necessary  to  allow 

assessment of their geographical  USE risk until 30 June  1998 at the latest,  for 

these 

Member  States,  the  entry  into  force  of  the  enlarged  Community  SRM  list  will  be 

suspended  until 31 December  1998 in order to allow for the scientific  assessment and 

the  subsequent  decision  making.  However,  Member  States  with  BSE  cases  in  their 

cattle  population  have  to  apply  SRM  removal  rules  on  the  basis  of  a  shorter  list. 

However  this  list  cannot  be  shorter  than  the  list  recommended  by  the  Office 

international des Epizooties (OIE) in 1997. 

Third countries will also be invited to submit the necessary data in the same time 

scale.  Imports  from  third  countries,  which  have  followed  this  invitation  (except 

Switzerland  which  has native BSE cases), will  be exempted  from  the requirement  of 

SRM  removal  until  31  December  1998. I'or imports  from  Switzerland  the  1997 OIE 

list of SRM will apply  until this date. 

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  after  validation  will  have  been  carried 

out.  A  derogation  for  relevant  products  derived  from  tested  carcasses  to  be  imported 

from third countries  is also  foreseen. 

A  derogation  for  the  use  of  SRM  in  certain  products  covered  by  sectoral 

legislation, e.g.  medicinal  and cosmetic  products, and industrial  products is  foreseen. 

2.  This decision  is  in accordance  with  the advice  given  by  the  SSC  on  9  December 

1997  and  improves  consumer  safety  while  avoiding  unjustified  trade,  economic  and 

technical  consequences.  In addition  it allows  for taking  into account  future  scientific 

advice and  for respecting  WTO notification  requirements. 

3.  This  decision  will  be  combined  with  the  reinforced  implementation  of  existing 

measures  for  minimising  the  BSE  risk and improved  surveillance  (see  separate  draft 

decision  on epidemio-surveillance for TSE and amending Decision  94/474/EC). 

In  the  Standing  Veterinary  Committee  meeting  of  4  March  Greece,  Spain  and 

Sweden  supported  the  proposal.  The  Netherlands  voted  against  the proposal  because 

they  feel  TSEs  are diseases  for which  régionalisation  is  impossible  in  principle.  The 

United  Kingdom,  France,  Luxembourg,  Portugal  and  Belgium  are  against 

régionalisation  before 

the  criteria  have  been  harmonised,  but  could  accept 

régionalisation  in  future.  Belgium,  Denmark,  Germany,  Ireland,  Italy,  Austria  and 

Finland  are  against  the  proposal  because  of  the  enlarged  list  of  SRMs,  which  they 

consider  unscientific  and  which  would  automatically  come  into  force  on  1 January 

1999, in the absence of a Commission decision. 

The  Commission  not  having  received  a  favourable  opinion  from  the  Standing 

Veterinary  Committee,  is  required  under  Article  17 of  Directive  89/662  to  submit a 

porposal  to the Council  without delay. 

1 

PROPOSAL for a 

COUNCIL  DECISION 

of 

on the prohibition of the use of material  presenting risks as regards transmissible 

spongiform  encephalopathies and repealing  Decision  97/534/EC 

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  market  , as last amended by Directive 92/118/EEC  , and in particular Article 9 

(4)  thereof, 

I laving 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  market, 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  organization  of  veterinary  checks  on  products  entering  the 

Community  from  third  countries  ,  as  last  amended  by  Directive  96/43/EC5,  and  in 

particular Article  19 thereof, 

I laving regard the proposal of the Commission, 

1  OJ No L 395, 30.12.1989, p. 13. 
2  OJ No 1.62,  15.3.1993, p. 49. 
,  OJNoL224,  18.8.1990, p. 29. 
4  OJ No L 373, 31.12.1990, p.  I. 
5  O J N oL  162,  1.7.1996, p.  I. 

5" 

(1)  Whereas  under  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  new  information  has  been  published  in  the  United  Kingdom  further 

supporting 

the  hypothesis 

that  exposure 

to 

the  bovine 

spongiform 

encephalopathy  (BSE)  agent  is  linked  to  the  new  variant  of  Creutzfeldt  Jacob 

Disease  (CJD)  in  humans;  whereas  on  16  September  1997  the  Spongiform 

Encephalopathy  Advisory  Committee  (SEAC)  of  the  United  Kingdom 

concluded  that  recent  research  provided  compelling  new  evidence  that  the 

agent  which causes  BSE  is  identical  to the agent which causes  the new  variant 

of CJD in humans; whereas on  18 September  1997 the Advisory  Committee  on 

Dangerous  Pathogens  (ACDP)  concluded  that  the  BSE  agent  should  now  be 

classified  as a human pathogen; 

(3)  Whereas  Commission  Decision  94/381/EC  of  27  June  1994  concerning  certain 

protection  measures  with  regard  to  bovine  spongiform  encephalopathy  and  the 

feeding  of  mammalian  derived  protein ',  as  amended  by  Decision  95/60/LC7, 

prohibited  the  feeding  of  mammalian  protein  to  ruminants  throughout  the 

Community; 

(4)  Whereas  Commission  Decision  96/239/EC  of  27  March  1996  on  emergency 

measures to protect against bovine  spongiform  encephalopathy8,  as amended by 

Decision  96/362/EC9,  was  adopted  pending  further  evaluation  of  the  new 

information and further measures to protect animal and public health; 

"  O J N o l,  172, 7.7.1994, p. 23. 
7  ( ) J N o L 5 5,  11.3.1995, p. 43. 
K  OJ No L 78, 28.3.1996, p. 47. 
9  O J N oL  139, 12.6.1996, p. 17. 

€ 

(5)  Whereas  Commission  Decision  96/449/EC of  18 July  1996 on the approval  of 

alternative heat treatment systems for processing animal waste with a view to the 

inactivation of spongiform  encephalopathy agents  , lays down the best available 

method  for  processing  animal  waste  as  regards  spongiform  encephalopathy 

agents; 

(6)  Whereas a group of experts convened  by  WHO on  3 April  1996 recommended 

that  no part or product of any animal  which  had shown  signs of a transmissible 

spongiform  encephalopathy  (FSE)  should  enter  any  food  chain  (human  or 

animal), and that countries should not permit tissues that are likely to contain the 

BSE  agent  to  enter  any  food  chain  (human  or  animal); whereas  the  Scientific 

Veterinary  Committee  has  assessed  the  measures  needed  in  the  whole 

Community  in  order  to  put  the  recommendations  of that  group  of experts  into 

effect; 

(7)  Whereas the  Scientific  Veterinary  Committee  has concluded  on the  basis of  its 

risk assessment that the rendering procedure using  133 °C at 3 bar for 20 minutes 

is the most important factor  to assure the safety  of meat-and-bone meal, but that 

this system  cannot  completely  guarantee  the complete  removal  of a TSE agent 

present  in  the  material  to  be rendered  if the system  is challenged  with  material 

with high infcctivity; 

(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 food  and feed  chains in countries or regions where a potential 

risk  is identified, and that, in the case of fallen  cattle, sheep and goats, either the 

specified  risk materials should be removed so that they do not enter any  food or 

feed chain, or the whole carcase should be destroyed; 

10  OJ No L 184,24.7.1996, p. 43. 

((>)  Whereas on  the basis of the advice of the Scienlilic  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 encephalopathies 

, as amended by Decision 97/866/EC  ; 

( 10)  Whereas the Scientific  Steering Committee (SSC) adopted an opinion on 9 

December  1997; whereas in this 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; 

(11)  Whereas in the light of the new scientific  advice  it is necessary  to amend the 

list of specific  risk materials laid down in Decision 97/534/EC; whereas this 

list should apply as from  1 July  1998; whereas Member States and third 

countries in so far as concerns their exports to the Community  should be 

allowed  to ask for a total or partial derogation from the ban on specified  risk 

materials in the light of their geographical  risk; whereas it is necessary  to 

establish a procedure  for submission of the data necessary  to allow  assessment 

of the geographical  BSE risk; whereas pending such scientific  assessment and 

the subsequent decision  on the matter, the application of the enlarged  list of 

specified  risk materials should be suspended  until a date not later than 31 

December  1998; whereas, however,  Member States and third countries with 

BSE cases  in their bovine animal  population and currently applying the 

removal  of risk materials should at least remove the materials recommended by 

the World Organisation for Animal Health (Office  international des Epizooties; 

OIE) in  1997; 

11  O J N"  L 216, 8.8.1997, p.95. 
12 OJL  351, 23.12.1997, p. 69. 

(12)  Whereas Article 3.2.13.12 of the Animal Health Code of the OIE recommends 

that bovine brain, eyes, spinal cord, tonsils, thymus, spleen and distal ileum 

(tissues under study) 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 that Code recommends in the same 

Article that bovine brain, eyes, spinal cord and distal ileum (tissues under study) 

and protein products derived  from  them from cattle over six months of age, 

originating from countries with a low incidence of BSE, which were born before 

the feed ban was effectively  enforced  should not be traded between countries; 

(13)  Whereas it is necessary  for practical and precautionary reasons to exclude the use 

of spleens from ovine and caprine animals, irrespective of age, and mechanically 

recovered meat from the vertebral column of bovine, ovine and caprine animals; 

(14)  Whereas  measures  must  be  implemented  in  order  to  protect  ruminants  from 

scrapie  pending  a  proper  epidemiological  evaluation  of  the  situation  in  the 

Community; 

(15)  Whereas certain  Member States have already excluded certain  material  from  the 

food  and  feed  chains;  whereas  the  United  Kingdom  has  prohibited  tissues  in 

addition to those recommended by the Scientific  Veterinary Committee; 

( 16)  Whereas the United Kingdom is considered to be a country with a high incidence 

of BSE; whereas the tissues included on the list of specified  bovine materials of 

the United Kingdom are in conformity  with the list of the aforementioned  Article 

of the Animal  Health Code; whereas, therefore,  the United  Kingdom  should  be 

authorized  to  keep  the existing  national  measures  in  respect  of the  removal  of 

specified  bovine material in force; 

( 17)  Whereas a risk assessment based on accepted  scientific  methodology  may show 

that there is a significantly  higher risk of exposure of animals or humans to TSEs 

in  certain  Member  Stales;  whereas  those  Member  States  may  take  action  in 

respect  of  the  removal  of  additional  risk  material  from  animals  slaughtered  on 

their territory; 

(18)  Whereas  equivalent  guarantees  are  required  for  imports  from  third  countries; 

whereas the situation as regards TSEs may vary between countries and the import 

requirements may therefore be adapted to the particular situation of the countries 

of origin  or dispatch;  whereas  the  import  of  specified  risk  materials  should  be 

allowed only for the purposes for which their use in the Community is permitted; 

( 1 <))  Whereas the 20th Commission  Directive 97/1 /EC of 10 January  1997 adapting to 

technical  progress Annexes  II, III, VI and  VII of Council  Directive  76/768/EEC 

on  the  approximation  of  the  laws  of  the  Member  States  relating  to  cosmetic 

products  bans  provisionally  the  marketing  of  cosmetic  products  containing 

bovine, ovine and caprine tissues and fluids from the encephalon, the spinal cord 

and  the  eyes,  and  the  ingredients  derived  therefrom;  whereas  that  Directive  is 

being amended to take account of the provisions of Decision 97/534/EC; 

(20)  Whereas the marketing of medicinal  products in the Community  is regulated by 

Council Directive 75/318/EEC of 20 May  1975 on the approximation of the laws 

of  Member  States  relating  to  analytical,  pharmaco-toxicological  and  clinical 

standards  and  protocols  in  respect  of  the  testing  of  proprietary  medicinal 
products  , as last amended by Directive l)3/39/HHC  , and by Council  Directive 

81 /852/EEC  of  28  September  1981  on  the  approximation  of  the  laws  of  the 

Member  States  relating  to  analytical,  pharmaco-toxicological  and  clinical 

standards  and  protocols  in  respect  of  the  testing  of  veterinary  medicinal 
products16, as last amended  by Directive 93/40/EEC  ; whereas these Directives 

n  O J N oL  16,  18.1.1997, p. 85. 
14  O J N o l,  147, 9.6.1975, p.  I. 
15 OJ  1,214, 24.8.1993,  p. 22. 
16  OJ  No  L 317, 6.11.1981,  p.  16. 

10 

are being amended to take account of the provisions of Decision 97/534/EC; 

(21)  Whereas  the  amendments  to  Directives  97/1/EC,  75/318/EEC  and  81/852/EEC 

provide  for the protection  of public  health  in respect  of the use of specified  risk 

material  in  cosmetic  and  medicinal  products  placed  on  the  market  in  the 

Community;  whereas,  therefore,  the  regulation  of  these  products  may  be 

excluded  from  the  scope  of  this  Decision;  whereas,  however,  there  remains  a 

need  to  allow  for  derogations  for  the  production  of  medicinal  products  and 

medical  devices, their starting materials or intermediate products, in those cases 

where  the  competent  authority  has  determined  that  no  satisfactory  alternative 

exists;  whereas  the  operation  of  any  such  derogation  will  be  regulated  by 

Community rules laid down elsewhere; 

(22)  Whereas for in vitro diagnostic  medical  devices the use of SRM should  remain 

possible  where  necessary  for  the  correct  performance  of  such  products; 

whereas  conditions  of  use  of  specified  risk  materials  including  related  time 

schedules  should  be laid  down  in this  Decision  for  medical  devices  within  the 

IK 

meaning  of  Council  Directive  90/385/EEC  ,  as  last  amended  by  Directive 

93/68/EEC  ,  and  Council  Directive  93/42/EEC  ;  whereas  those  conditions 

should  not apply to in vitro medical devices; 

(23)  Whereas the measures provided for in this Decision will further  contribute to the 

safe  sourcing, processing and use of ruminant material  for  food,  feed,  medicinal 

products, medical devices and cosmetic products; 

(24)  Whereas there are no effective  controls or tests which can determine whether or 

not particular tissues have been used in the manufacturing  of products;; whereas, 

therefore;  those  tissues  should  be removed  at slaughterhouses  and  subsequently 

destroyed;  whereas  Member  States  should  also  be  authorised  to  permit  their 

17 OJL 214, 24.8.1993, p. 31. 
18  OJNoL  189,20.7.1990, p. 17. 
19 OJL 220, 30.8.1993, p.  1 
20 OJL  169, 12.7.1993, p. 1. 

11 

removal  at  cutting  plants,  high-risk  processing  plants  or  premises  referred  to  in 

Article  7  of  Council  Directive  90/667/EEC 

,  as  last  amended  by  Directive 

92/118/EEC,  and,  as  regards  vertebral  columns,  at  the  point  of  sale  to  the 

consumer; 

(25)  Whereas  it  is  appropriate  to  provide  for  derogations  to  permit  the  use  of 

materials  covered  by  this  Decision  for  teaching  and  research  purposes,  for  the 

production  of  products  for  purposes  other  than  human  food,  animal  feed, 

medicinal  products or cosmetic  products and  for  feeding  fur  animals,  in  addition 

to  the  derogations  referred  to  above  in  respect  of  medicinal  products,  medical 

devices and cosmetic  products; 

(26)  Whereas  inspections  were carried  out  in the  Member  States  in  1996 and  1997 to 

check  the  implementation  of  Community  measures  on  BSE;  whereas  the  results 

of 

those 

inspections  have  revealed  certain  deficiencies, 

in  particular 

in 

surveillance  and  implementation  of the prohibition  on use of mammalian  protein 

in ruminant  feed; whereas further  inspections are necessary; 

(27)  Whereas  in  view  of  previous  trade  in  certain  products,  in  particular  meat  and 

bone  meal  and  live animals, the possible  presence of TSE agents cannot  be  ruled 

out  in  any  of  the  Member  Slates;  whereas  further  scientific  evaluation  is 

necessary  before  a  linal  assessment  of  the  regional  risk  of  the  presence  of  TSE 

agents can  be made; 

(28)  Whereas this Decision  will be reviewed  in the light of new scientific  information 

with regard to risk of exposure to TSEs resulting from infectivity  in other  animal 

species, age categories, tissues or materials not  covered by this Decision; 

(29)  Whereas the possibility  exists that post-mortem  tests for  BSE may  be 

developed  and  validated;  whereas  it is appropriate  to provide  for  the  approval 

of such  tests to lay down  rules  for their  use; whereas  provision  should  be  made 

()JN"L363, 27.12.1990, p.51 

12 

for an exemption  for Member States applying a compulsory  single carcass test 

for bovine animals above a certain age; 

(30)  Whereas  scientific  investigations  have  indicated  that  stunning  or  killing  by 

means  of  a  gas  injected  into  the  cranial  cavity  and  pithing  may  result  in 

fragments of brain tissue entering the circulation  and lodging  in certain organs; 

whereas  this  could  present  a  risk  to  consumers  of  those  organs;  whereas, 

therefore,  those  practices  should  be  prohibited  in  areas  where  there  is  a  risk 

from  BSE; 

(31 )  Whereas for reasons of transparency  Decision 97/534/EC  should be repealed and 

replaced by this Decision; 

(32)  Whereas the Standing Veterinary Committee has not given a favourable opinion, 

13 

HAS ADOPTED THIS DECISION: 

Article  1 

1. 

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

(a) 

"specified  risk  material" shall  mean: 

(i) 

the skull, including the brain and dura mater, the pituitary 

gland, the eyes, the tonsils, the intestines from the duodenum 

to the rectum, the vertebral column, including the dorsal root 

ganglia, spinal cord and dura mater, of: 

bovine animals aged over  12 months, 

ovine and caprine animals which are aged over  12 

months or have a permanent incisor tooth erupted 

through the gum; 

(ii) 

the spleens of ovine and caprine animals; 

(b) 

"native  case  of  BSE"  shall  mean  a  case  of  BSE  for  which  an 

epidemiological  investigation  conducted  by  the  competent  authority 

led to the conclusion  that exposure  of the affected  animal  to the agent 

took place within the territory of the country concerned; 

(c) 

"pithing"  shall  mean  the  laceration  after  stunning  of  central  nervous 

tissue  by means of an elongated  rodshaped  instrument  introduced  into 

the cranial cavity. 

2. 

Unless  otherwise  specified,  any  reference  to  "specified  risk  material"  in  this 

Decision  is  a  reference  to  the  tissues  specified  in  paragraph  1  (a),  not  to 

products containing or derived from those tissues. 

14 

Article  2 

I. 

Member  Slates  shall  ensure  that  the  following  slaughter  techniques  are  not 

used after  30 June  1998 on bovine, ovine and caprine animals whose  meat is  intended 

for human or animal  consumption: 

(a) 

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

that method; 

(b) 

pithing. 

2. 

The use of the vertebral column of bovine, ovine and caprine animals for the 

production of mechanically  recovered meat shall be prohibited after 30 June  1998. This 

shall  not apply to animals which are subjected to a test in accordance with Article 6. 

Article  3 

1. 

Member  States  shall  ensure  that  after  30  June  1998  the  specified  risk 

materials  from  animals  which  died  or  were  slaughtered  on  their  territory,  are 

removed  under the direct supervision of an official  of the competent authority and are 

destroyed  in accordance  with Article 4. 

2. 

The specified  risk materials shall  be removed at slaughterhouses. 

3. 

By  way  of  derogation  from  paragraph  2,  Member  States  may  allow  the 

removal  of: 

(a) 

specilied  risk  material  at cutting  plants,  high  risk  processing  plants or 

premises  referred  to  in  Article  7  of  Directive  90/667/EEC.  Those 

establishments  shall  be  approved  for  that  purpose  by  the  competent 

authority; 

15 

(b) 

the  vertebral  column  at  the  point  of  sale  to  the  consumer  on  their 

territory. 

4. 

The Commission  may establish conditions,  in particular with regard to 

checks,  in  accordance  with  the  procedure  laid  down  in  Article  18  of  Directive 

89/662/EEC. 

5. 

By  way  of  derogation  from  paragraph  1,  where  bovine,  ovine  or  caprine 

animals  have  died  or  have  been  killed  in  the  context  of  disease  control  measures, 

their  entire  body  may  be  destroyed  by  one  of  the  methods  referred  to  in  Article  4 

without removal  of the specified risk materials. 

Article  4 

Specified  risk  material  shall  be  stained  with  a  dye  immediately  on  removal.  All 

specilied risk material, including that obtained before  1  July  1998, shall be destroyed: 

(a) 

by 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. 

16 

Article 5 

1. 

Member  States may derogate from the provisions of Articles 3 and 4 to allow 

the burning or burial of specified  risk material or entire bodies in  the circumstances set 

out in Article 3(2) of Directive 90/667/EEC. 

2. 

Member Slates may derogate  from  the provisions of Articles  3 and 4 to allow 

the use of specified  risk material: 

(a) 

for  the  purposes  of  teaching  or  research  in  officially  recognized 

establishments; 

(b) 

for feeding fur animals. 

3. 

Member Stales may derogate  from  the provisions of Article 4 to allow the use 

of specified  risk material: 

(a) 

for  the  production  of  medicinal  products,  their  starting  materials  or 

intermediate  products  subject 

to 

the  provisions  of  Directives 

75/318/EEC and 81/852/EEC; 

(b) 

for the production of in-vitro diagnostic medical devices and of medical 

devices within the meaning of Directive 93/42/EEC which are not 

intended to come into direct contact with patients, including their 

starting materials or intermediate products; 

(c) 

for the production of medical devices within the meaning of Directive 

90/385/EEC and of Directive 93/42/EEC which are intended to come in 

direct contact with patients, including their starting materials or 

intermediate products; further  conditions are laid down in Annex II; 

17 

(d) 

for  the  production  of  cosmetic  products,  their  starting  materials  or 

intermediate  products,  subject 

to 

the  provisions  of  Directive 

76/768/EEC; 

(e) 

for the production of products other than those referred to in points (a) 

to (d) which are not intended for use in human food, animal feed or 

fertilisers. 

Article 6 

I. 

Member States may authorise, as an alternative to the removal of specilicd 

risk materials provided  for in Articles 3 and  12 or by way of derogation  from  the 

prohibition  laid down in Article 2 (2), the application of a post-slaughter test which 

has been approved in accordance with Article  18 of Directive 89/662/EEC, provided 

that at least: 

(a) 

tests are be carried out in the slaughterhouses on all bovine animals 

aged over  12 months, and as appropriate, on all ovine and caprine 

animals which are aged over  12 months or have a permanent incisor 

tooth erupted through the gum; 

(b) 

the spleens of ovine and caprine animals are removed and destroyed in 

accordance with Article 4; 

(c) 

no bovine, ovine or caprine material leaves the slaughterhouse  before 

the results of the tests on all slaughtered animals produced in the same 

batch, that is after one process of cleaning and disinfection  of the 

slaughterchain and before the next, have been received and accepted 

by the competent authority; 

(d) 

when a post-slaughter test gives a positive result, all bovine, ovine and 

caprine material produced in the same batch after the last process of 

cleaning and disinfection  of the slaughterchain  is destroyed in 

accordance with Article 4. 

2. 

With respect to products referred  to in Annex III which may be imported into 

the Community, third countries may authorise as an alternative to the removal of 

specified  risk materials, the application of a post-slaughter test which has been 

approved  in accordance with this Decision, provided that at least the conditions set 

out  in paragraph  1  are met. 

Article 7 

1. 

To ensure that this Decision is applied correctly, 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 

take measures to avoid contamination. 

2. 

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

(a) 

where  derogations  have  been  granted  in accordance  with  Article  3 (3) 

for  the removal  of specified  risk  materials at establishments  other than 

slaughterhouses,  those  materials  are  completely  separated  from  other 

waste,  are  collected  separately,  and  are destroyed  in accordance  with 

Article 4; 

(b) 

specified  risk  materials  for  which  derogations  have  been  granted  in 

accordance  with  Article  5  (2)  and  (3)  are  exclusively  used  for  the 

authorised purpose; 

19 

(c) 

where  live  bovine,  ovine  or caprine  animals  originating  from  Member 

States or third countries in which native cases of BSE have occurred are 

received  by  Member  States  in  which  no  native  cases  of  BSE  have 

occurred  in accordance  with Article  12 (3), those animals remain under 

official  supervision  until  their  slaughter  or  until  dispatch  from  their 

territory. 

Article  8 

1. 

Without  prejudice  to  Article  5  (2)  and  (3),  the  import  into  the  Community  of 

specified  risk material shall be  prohibited after 30 June 1998. 

2. 

In order  to  be  imported  into  the  Community  after  30  June  1998,  products  of 

animal  origin  listed  in Annex  III which contain material derived from bovine, ovine or 

caprine  animals  produced  after  30  June  1998  and  are  intended  for  human  food  or 

animal  feed  must  be  accompanied  by  the  appropriate  certificate,  as  required  by 

Community  legislation,  supplemented  by  a  declaration  signed  by  the  competent 

authority of the country of production, worded as follows: 

"The  product  docs  not  contain,  and  is  not  derived  from,  specified  risk 

material,  as defined  in Commission  Decision  [98/ 

/EC], which  was 

produced  after  30  June  1998  or mechanically  recovered  meat  obtained 

from  the vertebral  column of bovine,  ovine or caprine  animals  after  30 

June 1998." 

or, 

"The  product  contains,  or is  derived  from,  material  produced  after  30 

June  1998  of  bovine,  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 [98/—/EC]". 

20 

Article  9 

Member  Stales  may  lake  further  precautionary  action  in relation  to animals  slaughtered 

on their own  territory. 

Article  10 

1. 

Member States or third countries may apply  for derogations  from  the provisions 

of this Decision, in the light of their epidemiological  status with respect to TSEs. 

2. 

Member  States or third  countries  wishing  to apply  for derogations  as referred  to 

in  paragraph  I  shall  submit  to  the  Commission  before  1 July  1998  an  application, 

together  with  supporting  documents,  for  recognition  of  their  epidemiological  status 

with  respect  to  TSEs  compiled  in  at  least  one  of  the  official 

languages  of  the 

Community,  in accordance with the provisions  laid down in Annex I. 

3. 

Without  prejudice  to  Articles  11 and  12  (1),  Member  States  which  submit  an 

application  in accordance  with  paragraph  2 shall  not  be obliged  to  apply  this  Decision 

to animals  which  were bom on and  have never  left  their territory, or to animals bom  or 

reared  on  the  territory  of another  country  which  has  likewise  submitted  an  application 

in accordance  with  paragraph 2. 

4. 

Without  prejudice  to  Article  11 (2)  and  Article  12 (2)  and  (3),  third  countries 

which  submit  an  application  in  accordance  with  paragraph  2  shall  not  be  obliged  to 

apply  Article 8. 

5. 

The  Commission  shall  communicate 

to  the  Member  States,  within 

the 

framework  of the  Standing  Veterinary  Committee,  the  names  of the  Member  States  or 

third countries which  have applied for derogations as referred  to in paragraph  1. 

21 

Article  11 

1. 

The  conditions  which  arc  to  apply  to  Member  States  and  third  countries 

which  have  submitted  an application  in accordance  with  Article  10 shall  be  laid  down 

by decision taken in accordance with the procedure  laid down  in Article  18 of  Directive 

89/662/EEC  after  consultation of the appropriate  Scientific  Committee and  if necessary 

after  Community  inspections.. 

2. 

The  Commission  shall  take a Decision  in accordance  with  paragraph  1 before 

1 January  1999.  Where  such  a Decision  is not  taken,  the  provisions  of Articles  2  and 

3 and, as appropriate,  Article  8 (2) shall  apply. 

Article  12 

1. 

Notwithstanding  Articles  10 and  11,  Member  States  in  which  native  cases  of 

BSE  have occurred  shall  ensure  that  from  1 July  1998 at the  latest, or, where  the  first 

native  case  of  BSE  occurs  after  31  May  1998,  no  later  than  one  month  after  official 

confirmation  thereof,  the  brains, eyes  spinal  cord  and  distal  ileum  of  bovine  animals 

aged  over  12  months  are  removed  in  accordance  with  the  conditions  laid  down  in 

Article  3(1)  and  (2)  from  animals  which  died  or  were  slaughtered  on  their  territory 

and  are destroyed  in accordance with  Article 4. 

2. 

Notwithstanding  Articles  10  and  11,  in  order  to  be  imported 

into  the 

Community  after  30  June  1998, products  of  animal  origin  listed  in  Annex  III  which 

contain  material  derived  from  bovine  animals  produced  after  30  June  1998  in  third 

countries  in  which  native  cases  of  BSE  have  occurred,  and  are  intended  for  human 

consumption  or  animal  feed,  must  from  1 July  1998  at  the  latest,  or  where  the  first 

native  case  of  BSE  occurs  after  31  May  1998,  no  later  than  one  month  after  official 

confirmation  thereof,  be  accompanied  by  the  appropriate  certificate,  as  required  by 

Community 

legislation,  supplemented  by  a  declaration  signed  by  the  competent 

authority  of the country  of production, worded  as  follows: 

22 

"The  product  does  not  contain  and  is  not  derived  from  brains,  eyes, 

spinal cord and distal  ileum of bovine animals aged over  12 months as 

referred  to in Commission  Decision  [98/ 

/EC] which  were obtained 

after  30 June  1998 or mechanically  recovered  meat  obtained  from  the 

vertebral column of bovine animals after 30 June 1998." 

or, 

"The  product  contains  or  is  derived  from  material  produced  after  30 

June  1998 of bovine animals which were tested  and  found  negative  for 

the  presence  of  BSE  using  a  test  which  was  approved  in  accordance 

with Commission  Decision [98/—/EC] ". 

However,  where  the  first  native  case  of  BSE  occurs  after  31  May  1998  the  date 

referred  to in the declaration may be replaced by a date no later than one month  after 

official  confirmation thereof. 

3. 

Notwithstanding  Articles  10 and  11, where animals coming  from  countries in 

which  native cases of BSE have occurred  are to be slaughtered  after  30 June  1998 in 

(he territory of Member States in which no native cases have occurred: 

(a) 

the  Member  State  of  destination  shall  ensure  that  the  specified  risk 

materials, or at least the risk  materials  referred  to  in  paragraph  1, are 

removed from  those animals 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. 

23 

(b) 

the Member State of dispatch shall ensure that: 

(i) 

the  animal  health  certificates  are  supplemented  by  the 

following  words to be entered  for bovine animals  in the section 

"Health  data  concerning  bovine  animals"  of  the  certificate 

22 
referred  to in Annex  l; to Council  Directive 97/12/EC  : 

The  animals  listed  below  were  bom  or  reared  (  )  in  a 

Member  State or third country  (  ) in which native  cases 

of BSE have occurred'; or, 

(  ) Delete  if not appropriate 

for  ovine  and  caprine  animals  at  the  request  of  the  Member 

State  of  destination,  in  section  V  "Health  information"  of  the 

certificates  referred  to  in  Annex  E  to  Council  Directive 

9I/68/EEC21: 

'the  animals  listed  below  were  born  or  reared  (')  in  a 

Member State or third country (  ) in which native  cases 

of BSE have occurred'. 

(  ) Delete if not appropriate 

(ii) 

the competent  authority  of the place  of destination  is  informed 

of  the  nature  of  the  bovine  animals,  or,  at  the  request  of  the 

Member  State  of  destination,  of  the  nature  of  the  ovine  and 

caprine  animals, 

in  each  consignment  by  means  of  a 

specifically  coded  AN I MO message or by fax; 

22 O J N oL  109, 25.4.1997, p.I. 
2 3O J N o L 4 6,  19.2.1991, p. 19. 

24 

(c) 

the third country of dispatch shall ensure that: 

(i) 

the appropriate  animal  health  certificates  are  supplemented  by 

the  following  words, to  be entered  in  the  appropriate  sections 

on health information  for bovine animals: 

'the  animals  listed  below  were  born  or  reared  ( )  in a 

Member State or third country ( ) in which native cases 
Member State or third cour 

of BSE have occurred'; or, 

(  ) Delete if not appropriate 

for  ovine  and  caprine  animals  at  the  request  of  the  Member 

State of destination: 

The  animals  listed  below  were  born  or  reared  (  )  in  a 

Member Slate or third country ( ) in which native cases 

of BSE have occurred' 

(  ) Delete if not appropriate 

(ii) 

the competent authority of the place of destination  is  informed 

of  the  nature  of  the  bovine  animals,  or,  at  the  request  of  the 

Member  State  of  destination,  of  the  nature  of  the  ovine  and 

caprine animals, in each consignment by fax. 

25 

Article  13 

1. 

This  Decision  shall  be  without  prejudice  to  the  provisions  of  Decision 

96/239/EC and Decision 94/474/EEC. 

2. 

Decision  97/534/EC  is hereby repealed and references to that Decision  shall 

be construed  as references  to the present  Decision. 

Article  14 

This Decision and the decisions referred to in Article  11 (1) shall be reviewed regularly 

in the  light of  new epidemiological  information  and scientific  information  with regard 

to  criteria  for  determining  the  level  of  risk  in  specific  regions  and  to  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  in  accordance 

with the procedure  laid down  in Article  18 of  Directive  89/662/EEC after  consultation 

oflhe  appropriate Scientific  Committee. 

Article  15 

This  Decision  shall  apply  from  1  April  1998.  It  does  not  apply  to  products  as 

referred  to  in  this  Decision,  containing  or  derived  from  specified  risk  materials 

produced before  1  July  1998. 

26 

Article 16 

This Decision is addressed to the Member States. 

Done at Brussels 

For the Council 

27 

ANNEX1 

Information  to be submitted in support of an application for recognition of 
epidemiological status under article 10 

All data must be provided on an annual basis and preferably  from  1980 onwards, but 
at least  from  1988. 
Applicant Slates must make every effort  to provide comprehensive and consistent 
information.  Data which are not provided or are regarded as incomplete or as 
unsatisfactory  may have to be replaced  by worst case assumption  for the purposes of a 
risk assessment. 

Information  must be provided on: 

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

(a)  absolute numbers of animals per species and breed, alive and at time of slaughter; 
(b) age distributions of animals per species and breed, sex and type; 
(c)  age distribution of animals per species and breed, sex and type at time of 

slaughter; 

(d) geographical distribution of the animals by species and breeds; 
(e)  geographical distribution of the animals by husbandry systems, herd sizes and 

production purposes; 

(0  system of identification  and capacities for tracing of animals. 

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. 

3. Animal feed 

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

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

husbandry system (in particularly the proportion of that MBM fed to bovine, ovine 
and caprine animals);. 

(c)  exported  MBM, specifying  country of destination. 

28 

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 oflaboratory  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; 
(I)  methodologies oflaboratory  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)  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 tallow 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)  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. 

29 

ANNEX H 

Use of specified  risk materials for the production of medical devices 

Specified  risk material must not be used for the manufacture of active 

implantable medical devices within the meaning of Directive 90/385/EEC and 

of medical devices within the meaning of Directive 93/42/EEC which are 

intended to come in direct contact with patients, unless the use of such 

material  is authorized  in accordance with this Decision. 

Without prejudice to point  1  and unless the use of specified  risk material is 

authorized in accordance with this Decision: 

(a) 

tallow derivatives may be used provided that they are produced 

following an appropriate, documented and validated method such as : 

transesterilication or hydrolysis at not less than 200°C for not 

less than 20 minutes under pressure (glycerol, fatty acids and 

fatty acid esters production); 

saponification  with NaOH  12 M : 

batch process : at not less than 95 °C for not less than 3 

hours, 

continuous process : at not less than  I40°C for not less 

than 8 minutes under pressure or equivalent.; 

(b)  materials of bovine, ovine or caprine origin which may be derived from 

specified  risk material may be used until 30 September  1999 as 

reagents or where they are only indirectly associated with the 

manufacturing  process or disappear from that manufacturing  process, 

unless there are no adequate alternatives; 

30 

(c) 

intestinal  material of bovine, ovine or caprine origin  may be used  for 

the production of sutures provided that: 

that raw material is sourced from countries where there is 

reliable evidence that no native cases of BSE have occurred, 

sourcing  is subject to veterinary control and inspection, 

that raw material used originated from animals certified  by a 

veterinarian as being fit for human consumption, 

evidence on safety  of sourcing,  including  health attestations  is 

retained by the manufacturer and 

all  relevant production processes are carried out in accordance 

with legal requirements so as to provide optimal  security; 

(d) 

materials of bovine, ovine or caprine origin which may be derived from 

specific  risk material  may be used until  31  March 2000 at the latest in 

the production of medical devices, for which and for so  long as there 

are no satisfactory  alternatives. 

3. 

Where materials of bovine, ovine or caprine origin are used, a risk  assessment 

must  be performed  which addresses all  relevant aspects, including  those in 

relation to the sourcing, nature and quantities of animal  material  used, 

production  processes and conditions of use of finished devices.  The above 

mentioned procedure shall  be documented. 

4. 

Compliance  with the provisions this Annex  must be verified  in the  framework 

of application of the procedures laid down  in Directives 90/385/EEC and 

93/42/EEC. 

5. 

Without prejudice to Article  15, the provisions of this Annex  must apply  to 

medical  devices manufactured,, after 31  March  1999 at the latest. 

31 

(Products referred  to in Article 6 (2), Article 8 (2) and Article  12 (2)) 

ANNEX  III 

(a)  'Fresh meat', as defined  by Council  Directive 64/433/EEC  ; 

(b)  'Minced  meat'  and  'meal  preparations',  as  defined  by  Council  Directive 

94/65/EC2; 

(c)  'Meat  products'  and  'other  products  of  animal  origin',  as  defined  by  Council 

Directive 77/99/EEC3; 

(d)  'Milk  products', as defined  by Council  Directive 92/46/EEC  , which are destined 

for human consumption  and containing gelatin or tallow; 

(e)  'Milk  products',  as  defined  by  Council  Directive  92/118/EEC,  which  are 

destined  for animal  consumption and containing gelatin or tallow; 

(0 

'Fishery  products',  as  defined  by  Council  Directive  91/493/EEC\  which  are 
destined for human consumption and containing gelatin or tallow; 

(g)  'Egg  products',  as  defined  by  Council  Directive  89/437/EEC  ,  which  are 

destined  for human consumption and containing gelatin or tallow; 

(h)  'Snails  or  frogs'  legs', as  referred  to  in Council  Directive  92/118/EEC,  which  are 

destined  for human consumption and containing gelatin or tallow; 

(i) 

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

(j) 

'Gelatin', as referred  to in Council  Directive 92/118/EEC; 

(k)  'Petfood',  as referred  to in Council  Directive 92/118/EEC; 

(I)  'Processed  animal protein', as referred to in Council  Directive 92/118/EEC; 

(m) 'Bones' and 'bone products', as referred to in Council  Directive  92/118/EEC; 

(n)  'Raw  material  for  the  manufacture  of  animal  feedingstuffs',  as  referred  to  in 

Council  Directive 92/118/EEC. 

1  OJ No L  121, 29.7.1964, p. 2012/64. 
2  OJ No L 368, 31.12.1994, p. 10. 
3  OJ No L 26, 31.1.1977, p.85. 
4  OJNoL268,  14.9.1992, p. 1. 
5  OJ No L 268, 24.9.1991, p. 15. 
6  OJ No L 212,22.7.1989, p. 87. 

32 

ISSN 0254-1475 

COM(98) 160 final 

DOCUMENTS 

EN 

05  15  03  02 

Catalogue  number  :  CB-CO-98-152-EN-C 

ISBN 92-78-31954-6 

Office  for Official  Publications of the European Communities 

L-2985  Luxembourg 

3> S