Proposal for a Council Decision on the prohibition of the use of material presenting risks as regards transmissible spongiform encephalopathies
Date: 1997-07-17
Institutions: European Commission
Subjects: animal disease, animal product, health control, import restriction, marketing

COMMISSION  OF THE  EUROPEAN  COMMUNITIES 

Brussels,  17.07.1997 
COM(97) 419 final 

Proposal  for a 

COUNCIL DECISION 

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

spongiform encephalopathies 

(presented by the Commission) 

EXPLANATORY MEMORANDUM 

BSE is thought to have arisen from sheep scrapie, although this is not confirmed.  Recent 

experiments  have  shown  that  sheep  can  be  infected  by  BSE,  producing  a  disease 

clinically  indistinguishable  from  scrapie.  It is therefore  possible  that BSE  is, in  fact,  a 

strain of scrapie. Furthermore, sheep in the Community have been fed on meat-and-bone 

meal, raising the possibility that they have been infected with BSE. 

A group of experts convened by WHO on 3 April  1996 recommended that  "No part or 

product  of  any  animal  which  has  shown  signs  of  a  transmissible  spongiform 

encephalopathy  should enter any food chain (human or animal)." and "Countries should 

not  permit  tissues  that  are  likely  to  contain  the  BSE  agent  to  enter  any  food  chain 

(human  or animal)." The  first  recommendation  is already  implemented  in  Community 

law. On 21 October  1996 the Scientific  Veterinary  Committee has given its opinion on 

-~-£ne"second recommendation (doc VI/6665/96 Rev 6 final) by written procedure. 

The Committee considered that, on the basis of studies of both experimental and natural 

infection,  and  allowing  for  a  margin  of  safety,  the  tissues  which  should  be  excluded 

from human food  and animal  feed  are the brain, eyes and spinal cord  from  cattle, sheep 

and  goats over one year of age and the spleens  of sheep and  goats over  six months  of 

age. On the basis of this advice, the attached  proposal  defines  these tissues, as well  as 

the  tonsils,  as  specified  risk  material  (hereafter  referred  to  as  SRM)  and  proposes  to 

prohibit their use. In addition, it is proposed  to prohibit the use of the vertebral  column 

of  cattle,  sheep  and  goats  for  the  production  of  mechanically  recovered  meat,  as  this 

process may result in the presence of fragments of spinal cord in the final product. 

The provisions are proposed to apply to all Member States but, as the risk of BSE in the 

UK remains  significantly  higher than in other Member  States, the existing measures in 

respect of the removal of specified bovine material in the UK will remain in force. 

2 -3 

The Commission proposal takes a precautionary approach, based on the scientific  advice 

first  outlined  by  the  WHO  expert  group  and  later  defined  in  detail  by  the  Scientific 

Veterinary Committee. 

When assessing the risk in Member States other than the UK and in third countries, the 

Commission  is aware  that  meat-and-bone  meal,  which  might  have  been  infected  with 

BSE,  was  exported  from  the  UK  in  considerable  quantities  between  the  early  1980s, 

when BSE entered the British herd, until  at least  1990 when  Member  States (and  most 

third countries) implemented national import bans on UK meat-and-bone meal. Animals 

in  many  other  countries  may  thus  have  been  exposed  to  infection,  to  an  unknown 

degree.  In  addition,  it  is estimated  that  a  significant  number  of  infected  animals  were 

dispatched from the UK in this period. Their tissues would have been rendered and may 

have been recycled in animal feed, thereby exposing animals in other Member States to 

the BSE agent. 

As no Member State or third country can at present demonstrate complete freedom  from 

all  transmissible  spongiform  encephalopathies  (for  example  BSE  or  scrapie),  it  is 

proposed  to  prohibit  the  use  of  the  specified  risk  materials  from  all  countries.  In 

accordance  with  the  Community's  WTO  obligations,  the  possibility  of  a  future 

derogation  for  third  countries  is  allowed  for  in  the  text.  Any  application  for  such  a 

derogation  would  have to  be made  in  accordance  with  international  rules  on freedom 

from TSEs  and  would  have  to  be  scientifically  reviewed  before  consideration  by  the 

Standing Veterinary Committee. 

No  such  derogation  is  proposed  for  Member  States,  as  the  exact  situation  regarding 

TSEs in Member States is unknown, with scrapie occurring throughout the Community. 

In addition, the granting of a derogation to a Member State on the basis of freedom  from 

TSEs would have to be accompanied by a ban on trade into that Member State of cattle, 

sheep and goats, thus disrupting the single market in live animals. 

Commission  Directive 97/1/EC of  10 January  1997 bans provisionally  the marketing of 

cosmetic  products  containing  certain  SRMs.  Similar  rules  with  regard  to  food  for 

humans and animals, medical and pharmaceutical products are necessary. 

As a certain period  of time is needed for  operators to adjust  to these rules, and for  the 

text  to  be  notified  to  the  WTO,  it  is  proposed  that  the  Decision  will  apply  from  1 

October 1997. 

A similar proposal when put to the Standing Veterinary  Committee for an opinion on 3 

December  1996  did  not  obtain  a  qualified  majority.  Having  received  an  unfavorable 

opinion the Commission  submitted  the proposal  to the Council  on  17 December  1996, 

where it was rejected by simple majority. 

Inspections  carried  out  in the  Member  States  in  1996 revealed  certain  deficiencies,  in 

particular  in  the  surveillance  and  implementation  of  the  ban  on  use  of  mammalian 

protein in ruminant feed. Trade in certain products in particular meat and bone meal and 

live  animals  from  the  UK  took  place  in  the  past.  Hence  no  Member  State  can  be 

considered 

to  be  free  from  a  potential  risk  from 

transmissible  spongiform 

encephalopathies. 

This proposal implements in part the future  actions to be taken on BSE as mentioned in 

the communication to the Commission of 14 May 1997. 

The Commission not having received a favourable opinion from the Standing 

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

proposal to the Council without delay. 

PROPOSAL FOR A COUNCIL DECISION 

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

spongiform encephalopathies 

(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 

1 

2 

market,  as  last  amended  by  Directive  92/118/EEC ,  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  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, 

Having regard to the proposal of the Commission, 

1  OJ No L 395,30.12.1989, p.13. 
2  OJNoL 62, 15.3.1993, p. 49. 
3  OJ No L 224, 18.8.1990, p. 29. 
4  OJ No L 373,31.12.1990, p. 1. 
5  OJNoL162,  1.7.1996, p. 1. 

Whereas according to the second subparagraph  of Article 9(1) of Directive  89/662/EEC 

and  the  second  subparagraph  of  Article  10(1)  of  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; 

Whereas  as  a  result  of  information  on  the  appearance  of  cases  of  a  new  variant  of 

Creutzfeldt-Jakob  disease  in the  United  Kingdom  a risk  of  transmission  of the  bovine 

spongiform  encephalopathy  (BSE)  agent  to  humans  or  other  animals  cannot  be  ruled 

out; 

Whereas  Commission  Decision  94/3 81/EC  of  27  June  1994  concerning  certain 

protection measures with regard to bovine spongiform  encephalopathy  and the  feeding 

ft 

7 

of  mammalian  derived  protein  ,  as  amended  by  Decision  95/60/EC  ,  prohibited  the 

feeding of mammalian protein to ruminants throughout the Community; 

Whereas  Commission  Decision  96/23 9/EC of 27 March  1996 on emergency  measures 

o 

to  protect  against  bovine  spongiform  encephalopathy  ,  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; 

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  OJ No L 172, 7.7.1994, p. 23. 
7  OJ No L 55, 11.3.1995, p. 43. 
8  OJ No L 78,28.3.1996, p. 47. 
9  OJNoL139,  12.6.1996, p. 17. 
10  OJ No LI 84,24.7.1996, p. 43. 

Whereas a group of experts convened  by  WHO on  3 April  Î996 recommended  that no 

part  or  product  of  any  animal  which  had  shown  signs  of  a  transmissible  spongiform 

encephalopathy  (TSE)  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  implement  the 

recommendations of the aforementioned  group of experts; 

Whereas  the  Scientific  Veterinary  Committee  has  concluded  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  infectivity; 

Whereas  the  Scientific  Veterinary  Committee  has  stated  that  several  Member  States 

including  the  United  Kingdom  have  reported  scrapie  in  native-born  sheep,  that  the 

presence  of  scrapie  cannot  be excluded  in any  Member  State where  sheep  are  present 

and that only a thorough epidemiological  investigation conducted to common  standards 

will give the necessary information about the scrapie status of each country; 

Whereas  measures  must  be  implemented  in  order  to  protect  ruminants  from  scrapie 

pending a proper epidemiological evaluation of the situation in the Community; 

Whereas the Scientific  Veterinary Committee has therefore recommended that  specified 

risk materials, defined  as brain, spinal cords 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; 

Whereas  it is necessary  for  practical  reasons to exclude the use of  spleens from sheep 

and  goats,  irrespective  of  age,  and  mechanically  recovered  meat  from  the  vertebral 

column of cattle, sheep and goats; 

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; whereas Article 3.2.13.12 of the 

Animal  Health  Code of the International  Office  of Epizootics recommends that bovine 

brains, 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  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 afore  mentioned  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; 

Whereas a risk analysis 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 States; whereas those Member States may take action in respect of the removal 

of additional risk material of animals slaughtered on their territory; 

Whereas,  although  the  situation  as  regards  TSEs  may  vary  between  Member  States, 

uniform  rules throughout  the  Community  should  be adopted  in  order to  ensure  a high 

level of health protection and to avoid distortion of trade; 

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 country of origin; 

Whereas  Commission  Directive  97/1/EC  of  10  January  1997  adapting  to  technical 

progress  Annexes  If,  III,  VI  and  VIÏ  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  the  measures  provided  for  in  this  Decision  further  contribute  to  the  safe 

sourcing,  processing  and  use  of  ruminant  material  for  food,  feed,  medical  and 

pharmaceutical products and cosmetic products; 

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, 

in  order  to  ensure  that  the  tissues  and  fluids  in  question  have  not  been  used  in  the 

manufacture  of products which are marketed in the Community, it is essential to ensure 

that those tissues are removed  and stained at the point of production,  and  subsequently 

destroyed by incineration, following rendering where necessary; whereas such measures 

will  also  ensure  that  those  tissues  are  excluded  from  food,  feed,  medical  and 

pharmaceutical products and cosmetic products; 

Whereas the Council, at its meeting of 17 December  1996, rejected by a simple  majority 

the Commission's  proposal on removal of specified risk materials; 

Whereas  inspections  were  carried  out  in  Member  States  in  1996  to  check  the 

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

inspections  are  now  available;  whereas  those  inspections  have  revealed  certain 

deficiencies,  in  particular  in  surveillance  and  implementation  of  the  ban  on  use  of 

mammalian protein in ruminant feed; 

" O J N oL  16, 18.1.1997, p. 85. 

10 

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 States; whereas on the basis of the results of the inspections, no Member State 

can therefore be considered to be free from a potential risk from TSEs; 

Whereas  the  Commission  will  review  this  Decision  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 yet covered by this Decision; 

Whereas the Commission will make proposals to set up an effective  TSE surveillance in 

the Member States; 

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

HAS ADOPTED THIS DECISION: 

Article 1 

For the purposes of this Decision "specified  risk material" shall be defined  as follows: 

(a) 

the skull, including the brain and eyes, tonsils and spinal cord  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; 

(b) 

the spleens of ovine and caprine animals. 

11 

Article  2 

The use of specified risk material for any purpose shall be prohibited. 

Article 3 

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

of mechanically recovered meat shall be prohibited. 

Article 4 

1. 

Specified risk material shall be stained with a dye on removal and either: 

(a) 

destroyed by incineration, or 

(b) 

provided  that  the  colour  of  the  dye  is  detectable  after  processing, 

processed  and  subsequently  incinerated,  buried,  burned  as  fuel  or 

otherwise disposed of by a similar method which precludes  the risk of 

transmission of a TSE. 

2. 

In  exceptional  circumstances  and  by  way  of  derogation  from  paragraph  1, 

specified risk material  may  be burned  or buried  in  strict  compliance  with the 
conditions laid down in Article 3(2) of Council Directive 90/667/EEC12. 

3. 

Member States may derogate from the provisions of Article 2 and paragraphs 1 

and 2 of this Article to allow the use of specified risk material for the purposes 

of teaching or research in officially recognized establishments 

12 OJ No L 363, 27.12.1990, p.51. 

12 

Article 5 

To ensure the correct application of this Decision, Member States shall carry out regular 

official  controls,  particularly  in  slaughterhouses,  cutting  plants,  storage  facilities  and 

animal waste processing plants, and take measures to avoid cross-contamination. 

Article 6 

1. 

Without  prejudice  to  Article  4(3)  the  import  into  the  Community  of  specified 

risk material is prohibited. 

2. 

In order to be imported into the Community, products of animal origin intended 

for food  or feed  shall 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  does  not  contain,  and  is  not  derived  from,  specified  risk 

material  as  defined  in  Council  Decision  97/ 

/EC  or  mechanically 

recovered  meat obtained  from  the vertebral  column  of bovine, ovine or 

caprine animals". 

3. 

In order to enable their products to be imported into the Community, producers 

of medical, pharmaceutical,  or cosmetic products, or their  starting  materials  or 

intermediate  products,  shall  upon  request  by  the  competent  authority  of  a 

Member  State,  supply  a  declaration  signed  by  the  competent  authority  of  the 

country of production, worded as follows: 

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

material as defined in Council Decision 97/—/EC  ". 

Reference  to the present Decision 

Reference to the present Decision 

13 

4. 

At  the  request  of  a  third  country,  derogations  from  the  provisions  of  this 

Decision  may  be  granted,  after  consultation  of  the  appropriate  Scientific 

Committee  and  in  accordance  with  the  procedure  laid  down  in  Article  18  of 

Directive  89/662/EEC,  subject  to  submission  by  the  third  country  of  adequate 

scientific data to justify  its request. 

Article 7 

Member  States may take further  action in relation to animals  slaughtered  on their  own 

territory. 

Article 8 

This Decision shall be reviewed regularly in the light of new scientific  information  with 

regard 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 

after  consultation  of  the  appropriate  Scientific  Committee  and  in  accordance  with  the 

procedure laid down in Article 18 of Directive 89/662/EEC. 

Article 9 

This Decision shall be without prejudice to the provisions of Decision 96/239/EC. 

Article 10 

This Decision shall apply from 1  October 1997. 

14 

Article 11 

This Decision is addressed to the Member States. 

Done at Brussels 

For the Council 

15 

ISSN 0254-1475 

COM(97) 419  final 

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