Communication from the Commission - TSE Road map
Date: 2005-07-15
Institutions: European Commission
Subjects: animal disease, animal nutrition, bovine spongiform encephalopathy, consumer protection, health legislation, veterinary legislation

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 15.07.2005 
COM(2005) 322 final 

COMMUNICATION FROM THE COMMISSION 

TSE Road map 

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TABLE OF CONTENTS 

1. 

2. 

Introduction .................................................................................................................. 4 

Amendments in the short and medium term (2005 - 2009). ........................................ 5 

2.1. 

Specified Risk Material................................................................................................ 5 

2.1.1.  Current legislation........................................................................................................ 5 

2.1.2.  Future policy option ..................................................................................................... 5 

2.2. 

Feed Ban ...................................................................................................................... 6 

2.2.1.  Current legislation........................................................................................................ 6 

2.2.2.  Future policy option ..................................................................................................... 6 

2.3. 

Monitoring programmes .............................................................................................. 7 

2.3.1.  Bovine animals............................................................................................................. 7 

2.3.2.  Small ruminants ........................................................................................................... 9 

2.3.3.  Cervids ....................................................................................................................... 10 

2.4. 

2.5. 

The categorisation of countries according their BSE risk.......................................... 10 

Review of culling policy with regard to TSEs in small ruminants ............................ 11 

2.5.1.  Current legislation...................................................................................................... 11 

2.5.2.  Future policy option ................................................................................................... 12 

2.6. 

Cohort culling in bovine animals ............................................................................... 12 

2.6.1.  Current legislation...................................................................................................... 12 

2.6.2.  Future policy option ................................................................................................... 12 

2.7. 

UK restrictions ........................................................................................................... 13 

2.7.1.  Current legislation...................................................................................................... 13 

2.7.2.  Future policy option ................................................................................................... 13 

3. 

3.1. 

3.2. 

3.3. 

3.4. 

4. 

5. 

Amendments on the long term (2009 - 2014) ............................................................ 14 

Surveillance................................................................................................................ 14 

Specified risk material................................................................................................ 14 

Certification of herds ................................................................................................. 14 

Genetic resistance in goat........................................................................................... 15 

alternative scenarios if the positive trend does not continue...................................... 15 

Conclusion ................................................................................................................. 15 

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6. 

7. 

8. 

Annex I....................................................................................................................... 17 

Annex II: Monitoring data ......................................................................................... 20 

Annex III: costs linked to the surveillance programme ............................................. 22 

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1. 

INTRODUCTION 

The  Commission  have  discussed  on  several  occasions  with  the  Member  States  and 
the European Parliament about the next steps in the BSE policy on different points 
such as SRM, feed ban and age of testing.  

We have come to the stage that amendments of certain measures could be envisaged 
if  the  positive  trend  continues  and  scientific  conditions  are  in  place  without 
endangering  the  health  of  the  consumer  or  the  policy  to  eradicate  BSE.  Indeed 
different  indicators  already  suggest  a  favourable  trend  in  the  BSE  epidemic  and  a 
clear improvement of the situation in recent years due to the risk reducing measures 
in  place.  Furthermore  inspection  reports  indicate  that  implementation  of  BSE 
requirements in the Member States has improved. The main indicators are presented 
in the charts 1 -3 in Annex I.  

There  is  a  significant  overall  decrease  in  the  number  of  cases  of  the  disease  across 
the  EU  (about  850  BSE  cases  in  2004  in  the  EU  25  compared  to  2129  BSE  cases 
in 2002 in the EU 15). It clearly demonstrates the downward trend of positive BSE 
cases detected over the last four years with a 35 % reduction since 2002.The decrease 
in  the  number  of  cases  by  birth  cohort  since  1996  is  presented  in  the  chart  I  in 
Annex I.  

The  chart  2  in  Annex  I  shows  the  year  of  birth  of  the  positive  BSE  cases  detected 
since  2001  excluding  UK.  The  top  of  the  curve  and  subsequent  downward  trend 
indicate the main contamination through feed in the years 1994 – 1995 followed by a 
sharp decrease due to the BSE measures taken e.g. partial feed ban in 1994 and total 
feed ban in 2001. The impact of the 2001 total feed ban can only be assessed in the 
coming years due to the mean incubation period of BSE of 6 – 8 years. 

The chart 3 in Annex I illustrates that the mean age of the positive cases in healthy 
slaughtered animals in EU 15 increased between 2001 to 2004 from 76.2 months to 
95.0  months  of  age;  in  2004,  the  mean  age  of  the  positive  cases  in  healthy 
slaughtered  animals  in  the  new  member  states  was  79.9  months.  This  indicates 
contamination during a well defined period in the past well before the stringent BSE 
measures came into force at Community level.  

Based on the improved situation, the Commission has taken this initiative to present 
a road map on the BSE strategy in the short, medium and long term.  

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Any  relaxation  following  the  scientific  assessment  should  be  initiated  by  an  open 
discussion with all stakeholders and supported by a strong communication strategy. 
Bearing in mind the political consequences following the first and second BSE crisis 
any relaxation although scientifically justified may call upon the political courage of 
the Member states to reduce the current measures in place. In setting our strategy the 
greatest importance is attached to maintaining the high level of consumer protection 
built  up  over  the  years  in  the  field  of  prevention,  control  and  eradication  of  the 
transmissible  spongiform  encephalopathies.  However,  in  this  process  it  is  also 
important  not  to  lose  sight  of  other  threats  to  animal  and  public  health  which  have 
emerged in recent years, including diseases such as SARS and new variants of avian 
influenza.  The  balance  of  evidence  is  increasingly  pointing  towards  the  need  to  re-
consider  the  current  priorities  in  the  field  of  food  safety  and  animal  health.  The 
encouraging trends in relation to BSE merit a considered review of the opportunities 
to focus on these new threats.  

2. 

AMENDMENTS IN THE SHORT AND MEDIUM TERM (2005 - 2009).  

2.1. 

Specified Risk Material  

Strategic goal:  

To ensure and maintain the current level of consumer protection by continuing 
to  assure  safe  removal  of  SRM  but  modify  list/age  based  on  new  &  evolving 
scientific opinion 

2.1.1.  Current legislation 

Specified risk material is the most important public health protection measure. The 
initial  list  of  SRM  was  established  based  on  the  scientific  knowledge  before  1995 
and the precautionary principle. Since then, the overall situation has been improved 
and  new  scientific  data  has  become  available.  The  restrictions  on  the  use  of  SRM 
include a prohibition to use such products for the production of derived products for 
use in food and feed such as tallow, gelatine, collagen and dicalcium phosphate. 

2.1.2.  Future policy option 

Any amendment of the current list of specified risk material should be based on new 
evolving scientific knowledge while maintaining the existing high level of consumer 
protection within the European Union. In addition, data from BSE active monitoring 
and surveillance should also be used to revise SRM policies. 

On  27-28  April  2005  the  European  Food  Safety  Authority  (EFSA)  adopted  an 
opinion on SRM supporting an increase of the current age limit for central nervous 
tissue from 12 to 21 or 30 months depending the value given to the extremely rare 
BSE  cases  detected  in  young  animals.  This  opinion  allows  for  reflection  on  an 
amendment of the current SRM list and in particular on the age limit for the removal 
of the vertebral column as a first step.  

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The list of SRM in small ruminants depends on the outcome of the risk assessment 
currently being carried out by EFSA.  

Pending  scientific  advice  on  tallow,  collagen  and  gelatine  processing  standards  for 
those  commodities  will  be  further  refined  with  possible  relaxation  compared  to  the 
current requirements.  

2.2. 

Feed Ban  

Strategic goal:  

A  relaxation  of  certain  measures  of  the  current  total  feed  ban  when  certain 
conditions are met  

2.2.1.  Current legislation  

A ban on the feeding of mammalian meat and bone meal (MBM) to cattle, sheep and 
goats  was  introduced  as  of  July  1994.  This  partial  ban  was  extended  to  a  total  EU 
wide  suspension  on  the  use  of  processed  animal  protein  in  feeds  for  any  animals 
farmed for the production of food on 1 January 2001 with some exceptions like the 
use  of  fish  meal  for  non-ruminants.  Any  presence  of  prohibited  constituents  of 
animal origin in feed is considered as a breach of the feed ban i.e. the zero-tolerance.  

2.2.2.  Future policy option  

The starting point when revising the current feed ban provisions should be risk-based 
but  at  the  same  time  taking  into  account  the  control  tools  in  place  to  evaluate  and 
ensure the proper implementation of this feed ban.  

2.2.2.1.  Environmental contamination (beet pulp) 

Analyses in Germany demonstrate that presence of bones in beet pulp is frequent (up 
to 10%) and cannot be avoided. The likely origin is bone fragments of wild animals 
in soil which stick to the beets and end up in sugar beet pulp fed to ruminants. The 
introduction of a tolerance on the presence of bone fragments in sugar beet pulp and 
other feedingstuffs due to this environmental contamination is being considered only 
when a robust risk assessment has demonstrated the absence of cross contamination 
or the fraudulent incorporation of meat-and-bone meal (MBM).  

2.2.2.2.  Fish meal  

• 

The use of fishmeal is currently prohibited in feed intended for ruminants and 
there are also important conditions applying to its use in feed intended for non-
ruminants.  In  order  to  obtain  a  more  risk  based  policy,  an  introduction  of  a 
tolerance  level  with  regard  to  a  small  presence  of  fishmeal  in  ruminant  feed 
due to cross contamination may be proposed. The purpose of such tolerance is 
to solve the unwanted side effects of the fishmeal ban on the feeding of non-
ruminants while respecting the position of the European Parliament, currently 
against the use of fishmeal in feedingstuffs for ruminants.  

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• 

The European Parliament is expected to have a general discussion of fishmeal 
mid 2005. A decision on a possible relaxation regarding the fishmeal ban will 
take  into  consideration  the  outcome  of  the  discussion  in  the  European 
Parliament. 

2.2.2.3.  Lifting feed ban provisions for non-ruminants  

Further  improvement  in  differentiating  animal  proteins  specific  to  certain  species 
may result in an amendment of the provisions with regard to the use in feedingstuffs 
of  animal  products,  in  particular  non-ruminant  proteins  taking  into  account  the 
prohibition on intra-species recycling in Regulation (EC) No 1774/2002 (e.g. poultry 
MBM  to  pigs).  Differential  tests  are  already  awaited  since  2001.  The  mandatory 
treatment of mammalian proteins at 133°C, 3 Bars during 20 minutes results in very 
small fragments of animal proteins which are hard to detect by the current analytical 
methods. 

Awaiting  the  validation  of  discriminatory  tests  and  pending  the  results  of  the 
quantitative  risk  assessment  by  the  EFSA  on  the  risk  linked  to  small  amount  of 
MBM, an introduction of a tolerance level with regard to a small presence of meat-
and-bone meal in feed may be proposed without jeopardising the current eradication 
measures.  

2.2.2.4.  Tallow  

Currently there are no specific restrictions with regard to the use of tallow in feed (or 
food)  to  prevent  transmission  of  TSEs.  The  restriction  on  the  use  of  specified  risk 
material  is  applicable  in  addition  to  the  mandatory  purification  of  rendered  fat  at 
0.15%  insoluble  impurities  in  Regulation  (EC)  No  1774/2002.  A  possible  need  for 
future  provisions  on  tallow,  in  particular  for  use  in  milk  replacers  depends  on  the 
result of the quantitative risk assessment (QRA). 

2.3.  Monitoring programmes  

Strategic goal:  

To reduce the numbers of tests of bovine animals and at the same time continue 
to measure the effectiveness of the measures in place with a better targeting of 
the surveillance activity 

2.3.1.  Bovine animals  

2.3.1.1.  Current legislation  

Up  until  the  middle  of  2000,  the  majority  of  BSE  cases  detected  were  found  by 
means of traditional passive surveillance, i.e. through the examination and mandatory 
reporting of animals suspected of showing signs or clinical symptoms of BSE. The 
detection of BSE in healthy slaughtered cattle in 2000 indicated the need for active 
monitoring which was introduced in the whole community in the beginning of 2001. 
The  active  monitoring  programme  became  fully  operational  in  July  2001  and  still 
includes:  

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– 

– 

The testing of all risk animals over 24 months of age (fallen stock, emergency 
slaughtered animals and animals with clinical signs at ante-mortem inspection)  

The testing of all healthy slaughtered bovine animals above 30 months of age 
(a total of 10 million cattle per year) 

The  table  1  in  Annex  II  gives  the  number  of  animals  tested  since  2001  for  the 
different  age  categories  and  different  categories  (healthy  slaughter,  risk  animals, 
fallen stock).  

For countries that have determined that BSE exists within the cattle population, the 
goal  of  surveillance  is  monitoring  of  the  effectiveness  of  control  measures  such  as 
feed  ban  and  SRM  removal  by  following  the  evolution  of  BSE  prevalence.  In 
addition in countries without (recent) BSE cases, the final goal of surveillance is to 
demonstrate that BSE is below an agreed threshold. It should be noted as well that, 
although  active  BSE  monitoring  is  not  a  public  health  protection  measure,  it  has 
contributed  to  increased  consumer  confidence  and  has  played  a  role  in  the 
communication strategy of certain member states. In addition the surveillance results 
have  provided  the  necessary  data  to  evaluate  an  amendment  of  the  current  list  of 
specified risk materials.  

2.3.1.2.  Future policy option  

(a)  Epidemiological considerations  

Based  on  the  results  of  the  ongoing  monitoring  programme  and  forthcoming 
results of the full testing programmes in the new Member States, a revision of 
the  monitoring  programme  may  be  envisaged  in  2005  in  order  to  lay  down  a 
strategy  which  moves  from  the  current  testing  regime  to  maintenance 
surveillance  based  on  the  CRL  model  in  the  long  term.  Different  options  for 
such transition should be analysed with epidemiologists and statisticians taking 
into account the above goals and cost benefits. Such options are:  

• 

• 

The  gradual  increase  of  the  age  limit  starting  for  healthy  slaughtered 
animals  and  fallen  stock.  The  increase  of  the  age  would  depend  on  the 
results of the ongoing surveillance programme.  

A decrease of monitoring of cattle born in years from which statistically 
sufficient  information  on  the  BSE  prevalence  is  available  but  focussing 
on  (recent)  years  of  birth  from  which  only  limited  information  is 
available.  

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(b)  Cost – benefit considerations  

Bearing in mind the goal of the surveillance the costs linked to the surveillance 
programme  should  be  weighted  against  the  information  received  through  the 
surveillance.  The  detailed  costs  are  enclosed  as  Annex  II  to  this  paper.  The 
costs include the co-financing by the Commission and the cost financed by the 
Member states1.  

The table 2 in Annex II gives the costs linked to the finding per positive case 
found in the different age groups. Note that the cost linked to the finding of 
the  one  positive  case  in  2002  in  healthy  slaughter  surveillance  stream  in 
the age group 30 -35 months is 302 Mio EURO.  

2.3.2. 

Small ruminants  

2.3.2.1.  Current legislation  

Apart from the mandatory examination and reporting of sheep and goats suspected of 
showing signs or clinical symptoms of a TSE, an active monitoring programme was 
introduced in the beginning of 2002. Since the confirmation of BSE in a goat in the 
beginning of 2005, the active monitoring includes:  

– 

– 

The testing of a minimum sample size including up to 10 000 sheep and 10 000 
goats  per  Member  State  of  risk  animals  over  18  months  of  age  (fallen  stock, 
emergency slaughtered animals and animals with clinical signs at ante-mortem 
inspection)  

The  testing  of  10  000  healthy  slaughtered  ovine  animals  above  18  months  of 
age  in  Member  States  with  a  large  population  and  a  minimum,  statistically 
based but high number of healthy slaughtered goats over 18 months of age. In 
most Member States all healthy slaughtered goats are tested.  

The current extended monitoring in goats will be reviewed in the second half of 2005 
and allows a fast and better estimate of BSE in goats in order to assess if the positive 
BSE case in the goat born in 2000 and slaughtered in France in 2002 was an isolated 
case.  

2.3.2.2.  Future policy option 

Future monitoring in small ruminants depends on the estimated prevalence of BSE in 
such animals based on the results of the current extended monitoring in goats and the 
results  from  discriminatory  testing  of  new  cases  and,  if  possible,  analysis  of  TSE 
cases in the past. In case the results of the ongoing monitoring indicate that the single 
BSE cases found in the goat was an isolated case, monitoring can be reduced or only 
continued for a limited period of time to increase the confidence in the results of the 
increased testing.  

1 

Average cost of a BSE rapid test is budgeted at 50 EURO with 8 Euro co-financed by the Commission. 

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In  the  worst  case  scenario  where  an  increase  of  BSE  cases  is  detected  in  the  small 
ruminant population, an increase of the surveillance might be envisaged.  

2.3.3.  Cervids  

At  this  moment  no  measures  are  foreseen  within  EU  regarding  Chronic  Wasting 
Disease (CWD. There is no evidence to suggest that CWD has occurred in the EU, or 
at  least  if  it  has  it  must  be  at  a  very  low  prevalence,  since  otherwise  it  should  be 
expected  to  have  been  detected  by  now.  Nor  is  there  any  concrete  evidence  of 
transmission of CWD to humans, or of susceptibility of deer to BSE. If experimental 
or field evidence of either were discovered, this would warrant a change in policy as 
regards CWD. 

Because  of  the  limited  surveillance  data  in  EU,  a  survey  will  be  initiated  in  the 
beginning  of  2006,  the  goal  of  which  is  to  confirm  the  situation.  This  will  be  a 
targeted  survey,  in  line  with  the  EFSA  opinion.  However  before  starting  with  the 
survey different risk management measures should be considered during the course 
of  survey  preparation  mainly  related  to  the  action  following  the  detection  of  a 
positive CWD case in cervids taking account of the scientific opinion linked to the 
risk. 

2.4. 

The categorisation of countries according their BSE risk.  

Strategic goal:  

Simplification  of  the  categorisation  criteria  and  conclude  the  categorisation  of 
the countries before 1 July 2007.  

The objective of a categorisation according to the BSE risk is to define trade rules for 
every  risk  category  which  will  give  the  necessary  guarantees  to  protect  animal  and 
public health for the importing countries. The conditions for such trade are already 
laid  down  in  the  current  recommendations  of  the  Terrestrial  Animal  Health  Code 
(“Code”) of the World Organisation for Animal health (OIE).  

The current five categorisation criteria in the Code lead to a final BSE status, which 
did not necessarily reflect the real situation. This is because some of the other criteria 
are unnecessarily rigid, and not adapted to the risk. Furthermore the present system 
with  five  categories  is  very  complicated.  It  is  also  not  necessary  to  maintain  three 
different categories for countries with a BSE risk, as the trade conditions are largely 
similar.  The  five  categories  were  introduced  in  the  TSE  Regulation,  pending 
agreement  in  the  OIE  on  a  revised  system.  OIE  started  two  years  ago  a  process  to 
review  and  simplify  the  categorisation  of  countries  according  their  BSE  risk  into 
three categories.  

At  the  General  Session  in  May  2005  an  agreement  was  reached  on  the  simplified 
categorisation  procedure  including  the  requirements  on  surveillance  within  the 
different  categories.  The  simplified  categorisation  procedure 
three 
categories:  

includes 

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Category  1:  Countries  with  a  negligible  BSE  risk  and  a  reduced  active 
surveillance  programme  detecting  a  design  prevalence  of  1  per  50  000  - 
imports allowed without restrictions;  

Category  2:  Countries  with  a  controlled  BSE  risk  and  active  surveillance 
programme detecting a design prevalence of 1 per 100 000 – imports allowed 
when SRM removed;  

Category  3:  Countries  with  an  undetermined  BSE  risk.  The  country  will  be 
allowed to export only a limited list of tradable products. 

Based  on  this  new  international  standard  the  current  provisions  under  the  TSE 
Regulation should be amended. Following adoption of the new categorisation criteria 
the  countries  should  be  categorised  starting  with  the  major  trading  partners.  If  OIE 
does  not  succeed  in  categorising  the  countries  before  1  July  2007  the  Community 
should categorise the countries according to the new international standard.  

2.5. 

Review of culling policy with regard to TSEs in small ruminants 

Strategic goal:  

Review and relaxation of the eradication measures for small ruminants taking 
into account the new diagnostic tools available but ensuring the current level of 
consumer protection 

2.5.1.  Current legislation 

The current provisions require a whole herd culling if TSE is detected in goats and a 
whole or partial (sensitive  genotypes) culling if TSE is detected in  sheep  including 
atypical cases. In order to improve the genetic resistance within the sheep population 
a  minimal  breeding  programme  became  mandatory  for  flocks  of  high  genetic  merit 
from 1 April 2005 on. Atypical cases are TSE cases in which BSE is excluded often 
detected  by  active  surveillance  without  clinical  signs,  with  no  or  very  limited 
spreading in a flock, but present in sheep with genotypes considered resistant to BSE 
(in contrast to classical scrapie). Furthermore the molecular discriminatory testing in 
force since January 2005, may exclude the presence of BSE within a few weeks in 
most TSE cases. When BSE is excluded, a public health risk is no longer present and 
total herd culling might be considered disproportionate on public health grounds. 

The table below gives the number of positives sheep and goats within infected herds  

Sheep 

Goats 

2002 

2003 

2004 

1.3% 

2.8% 

3.5% 

0.7% 

0.3% 

1.2% 

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It should be noted that in most flocks no additional cases are detected by culling, in 
particular when atypical cases had been found. In other flocks, a TSE infection was 
demonstrated in up to 40% of the animals. 

2.5.2.  Future policy option 

The Commission would like to propose a relaxation of the culling policy for all cases 
where BSE is excluded (sheep and goats) with an increased testing regime within the 
infected flocks and the slaughter for human consumption of all animals of all ages in 
infected  herds  if  negative  by  rapid  testing.  Conditions  for  herd  certification  should 
also be considered as an additional way of eradicating TSEs.  

2.6. 

Cohort culling in bovine animals  

Strategic goal: 

To stop the immediate culling of the cohort  

2.6.1.  Current legislation 

The  current  legislation  on  TSE  foresees  the  killing  and  destruction  (culling)  of  the 
cohort animals linked to a positive BSE. The cohort animals are animals without any 
symptoms but which are assumed to be a higher risk of being infected with BSE due 
to  an  epidemiological  link.  This  includes  in  case  of  female  animals  the  progeny  of 
the  positive  BSE  case  (“birth”  cohort)  or  animals  which  received  the  same  feed  as 
the positive animal in the first year of their life (“feed” cohorts).  

2.6.2.  Future policy option  

Reflection  on  alternatives  to  the  current  destruction  of  the  cohort  can  be  made.  A 
proposed alternative would be to defer the culling and destruction at the end of the 
productive  life,  as  foreseen  within  the  International  OIE  Animal  Health  Code  or  to 
allow the slaughtered animals into the food chain following a negative rapid testing 
result. Although this relaxation would allow breeding and use of milk the decision to 
derogate from the culling should be the responsibility of the Member states in order 
to  take  into  account  the  potential  consequences  for  their  export  markets.  The 
derogation to defer the culling would be the Member States decision. This relaxation 
would not endanger the current level of consumer protection. A relaxation would not 
only  reduce  the  economical  impact  but  also  the  social  consequences  following  the 
complete destruction of the cohorts being often one of the main reasons to object to 
the culling policy.  

The table below shows the number of animals culled and tested in 2003 – 2004 and 
the number of positives detected within the cohort animals.  

Year 
Animals tested 
BSE cases 

2003 
25.747 
10 

2004 
16.471 
5 

Total 
42.218 
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In the medium term slaughter for human consumption can be considered subject to a 
negative TSE  test, removal of specified risk materials and a decreasing prevalence. 
However, as the BSE prevalence reduces, the cost of culling also reduces and from a 
consumers perception (and trade) point of view the total herd culling for destruction 
may be the preferred option in particular in Member states where BSE was absent or 
very rare. This would be a Member States decision. 

2.7. 

UK restrictions  

Strategic goal:  

To  discuss  the  lifting  of  the  additional  restrictions  on  exports  of  beef  and  beef 
products from the UK if the preset conditions are complied with.  

2.7.1.  Current legislation  

Council  Decision  98/256/EC  (UK  embargo  Decision)  and  subsequent  amendments 
provides that the United Kingdom is to ensure that live bovine animals and products 
thereof  are  not  dispatched  from  its  territory  to  other  Member  States  or  to  third 
countries except under certain specified conditions (deboned, exclusion of cattle aged 
over 30 months etc).  

2.7.2.  Future policy option 

In  1996  the  United  Kingdom  introduced  the  Over-Thirty-Months  (OTM)  Rule  as  a 
public  health  protection  measure  which  bans  meat  from  most  cattle  aged  over 
30 months  at  slaughter  from  being  destined  for  human  consumption.  On 
1 December 2004  the  United  Kingdom  informed  the  Commission  on  the  decision 
taken to replace the OTM rule with a testing regime as in the other Member States 
and to exclude permanently cattle born before 1 August 1996 from the food and feed 
chain. 

Regarding the possible lifting of the UK embargo different conditions should be in 
place to start the discussion. These include a UK incidence fallen below the 200 BSE 
cases  per  million  adult  cattle  and  a  favourable  outcome  of  the  audit  mission  of  the 
Food  and  Veterinary  Office  (FVO)  in  June  2005.  On  the  10  March  2005  the 
European  Food  Safety  Authority  (EFSA)  confirmed  the  incidence  below  200  BSE 
cases per million adult cattle. 

When both conditions are complied with, in particular a favourable outcome of the 
FVO inspection, a discussion with the Member states on the lifting of the embargo 
could be initiated likely in the fourth quarter of 2005. 

EN 

13 

   EN 

 
3. 

AMENDMENTS ON THE LONG TERM (2009 - 2014) 

Strategic goal:  

To modify measures in line with current technology and new evolving scientific 
knowledge.  

In  case  the  positive  trend  continues,  taking  into  account  the  relaxation  of  the 
measures in the short and medium term, a further relaxation of the measures can be 
envisaged. The use of validated live animal tests may in the future allow tracing and 
culling  the  positive  animals  and  therefore  shortening  the  period  before  further 
relaxation measures can be taken. The different options could include: 

3.1. 

Surveillance  

Different scenarios can be envisaged on the long term:  

– 

– 

The  gradual  decrease  in  the  level  of  surveillance  can  be  maintained  if  the 
positive  trend  continues  focusing  on  older  animals  or  on  birth  cohorts  from 
which only limited information is available.  

If  only  BSE  cases  are  detected  in  animals  above  10  year  i.e.  born  before 
1 January 2002, it may be decided to exclude those animals permanently from 
the feed and food chain (destruction scheme) and provide financial support for 
the  culling  of  those  animals  at  the  end  of  their  productive  live.  The  final 
surveillance  strategy  would  be  reduced  to  the  examination  of  the  clinical 
suspect animals (passive surveillance) and a maintenance strategy in line with 
the OIE recommendations.  

– 

The option to test every animal with a live animal test, if available, at a certain 
age could also be envisaged.  

3.2. 

Specified risk material  

If BSE cases are not detected below a certain age or drop below an agreed prevalence 
the obligation to remove the specified risk material may be withdrawn within this age 
group. Alternatively, a permanent minimal list of SRM in particular nervous tissues 
(brain,  spinal  cord)  of  cattle  of  certain  age  groups  may  be  considered  as  a 
precautionary measure against future epidemics or sporadic cases.  

3.3. 

Certification of herds  

Following  the  testing  of  all  cattle  with  a  live  animal  test  a  certification  of  the  herd 
status  could  be  introduced  in  line  with  the  farm  certification  as  it  is  the  case  for 
tuberculosis or brucellosis.  

EN 

14 

   EN 

 
3.4. 

Genetic resistance in goat  

In  case  further  research  indicates  genetic resistance  of  certain  genotypes  within  the 
goat population the eradication strategy should be reviewed in the light of these new 
developments.  

4. 

ALTERNATIVE SCENARIOS IF THE POSITIVE TREND DOES NOT CONTINUE  

All  indicators  regarding  the  prevalence  of  BSE  in  bovine  animals  suggest  that  a 
future increase of BSE cases is unlikely. An alternative scenario should be included 
if  the  positive  trend  is  not  confirmed  in  certain  Member  states.  Furthermore  when 
considering a medium and long term strategy regarding small ruminants and cervids 
a possible worst case scenario should also be envisaged. This would include: 

• 

Non-favourable trend of BSE in certain Member states  

If the positive trend is not confirmed in certain Member states more stringent 
measures regarding SRM removal compared to the other Member states could 
be envisaged. At the last stage a temporary embargo might be envisaged which 
will  allow  addressing  the  situation  in  the  individual  Member  state  without 
penalising the other Member states where the negative trend is not confirmed.  

• 

BSE in small ruminants 

If,  following  the  intensive  surveillance  in  goats,  BSE  would  be  confirmed  at 
large scale within the sheep and goat population stringent measures should be 
taken which would include the full testing of small ruminants and consequently 
discriminatory testing of the TSE cases and an extensive list of SRM based on 
the scientific opinions which could lead in the worst scenario to the complete 
destruction of the carcass.  

This will also enforce the need for a breeding programme for resistance within 
the sheep population.  

• 

Chronic Wasting Disease (CWD) in cervids  

If CWD would be confirmed following the survey planned in 2006 a decision 
on the removal of specified risk material may be permanently in place.  

5. 

CONCLUSION 

We have come a long way and the Commission has introduced a comprehensive set 
of  stringent  Community  measures.  In  the  last  10  years,  the  Commission  has 
generated  70  primary  and  implementing  acts  which  set  stringent  measures  at 
Community  level.  The  key  piece  of  legislation  to  protect  human  and  animal  health 
from the risk of BSE and other TSE's was adopted on 22 May 2001. This Regulation 
(EC)  No  999/2001  of  the  European  Parliament  and  of  the  Council  lays  down  rules 
for  the  prevention,  control  and  eradication  of  certain  transmissible  spongiform 
encephalopathies, and is commonly known as the "TSE Regulation". This Regulation 
was applicable, within a very short time frame, as of 1 July 2001. 

EN 

15 

   EN 

 
 
 
 
 
Different  factors  indicate  a  favourable  trend  in  the  BSE  epidemic  and  a  clear 
improvement of the situation over the past years due to the risk reducing measures in 
place. The goal for the coming years for the TSE regulation is to ensure a relaxation 
of the measures while assuring the high level of food safety introduced through the 
TSE controls over the past 10 years. The relaxation of the measures should be risk 
based  and  reflect  advances  in  technology  as  well  as  evolving  scientific  knowledge 
and would also have a positive impact on the competitiveness of the industries and 
farmers involved within the Community.  

EN 

16 

   EN 

 
6. 

ANNEX I 

Chart 1: BSE cases from 2001 to 2004 

2500

2000

1500

1000

500

s
e
s
a
c
E
S
B

0

EU 10

EU 15

2001

2167

2002

2124

2003

12

1364

2004

27

825

EN 

EU 10
EU 15

17 
EN 

 
 
 
 
 
Chart 2 : BSE cases by birth cohorts 

s
e
s
a
c
E
S
B

2000

1800

1600

1400

1200

1000

800

600

400

200

0

1980 1981 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001

EU 25

1

1

1

4

5

29

66

75

101 125 219 418 848 1380 1740 775 381 208

84

27

2

Birth Cohort

EN 

18 
EN 

 
 
 
 
 
Chart 3: Mean age of positive cases in healthy slaughtered animals in EU 15 

s
e
s
a
c
E
S
B

f
o
e
g
a
n
a
e
M

100,0

95,0

90,0

85,0

80,0

75,0

70,0

65,0

60,0

EU 15

EN 

2001

76,2

2002

85,9

Year

2003

93,1

2004

95,0

19 
EN 

 
 
 
 
 
 
 
 
7. 

ANNEX II: MONITORING DATA  

Table 1: number of bovine animals tested from January 2001 to December 2004 

Age group 

Healthy slaughtered 

Risk animals 

Fallen Stock 

< 24 months 
24-29 
30-35 
36-41 
42-47 months 
>= 48 months 
Total 

3.370.000 
3.035.000 
6.715.000 
3.065.000 
2.400.000 
17.235.000 
35.820.000 

70.000 
455.000 
655.000 
395.000 
330.000 
3.060.000 
4.965.000 

55.000 
355.000 
515.000 
310.000 
260.000 
2.405.000 
3.900.000 

EN 

20 
EN 

 
 
 
Table 2: costs (Mio €) per BSE case detected between January 2001 until December 2004 

Age group 

Healthy slaughter 

Risk animals 

<24 months 
24-29 months 
30-35 months 
36-41 months 
42-47 months 
All <48 months 

All =>48 months 
All Ages 

No cases 
No cases 
302 
69 
11 
64 

0,76 
1,56 

No cases 
10,2 
29,5 
17,8 
0,9 
4,3 

0,04 
0,07 

EN 

21 
EN 

 
 
 
8. 

ANNEX III: COSTS LINKED TO THE SURVEILLANCE PROGRAMME  

Table 1: estimated age distribution of bovine animals tested from January 2001 to December 2004 

Age group 

< 24 months 
24-29 
30-35 
36-41 
42-47 months 
>= 48 months 
Total 

Healthy 
slaughtered 
3.370.000 
3.035.000 
6.715.000 
3.065.000 
2.400.000 
17.235.000 
35.820.000 

Risk animals 

(Fallen Stock) 

70.000 
455.000 
655.000 
395.000 
330.000 
3.060.000 
4.965.000 

55.000 
355.000 
515.000 
310.000 
260.000 
2.405.000 
3.900.000 

Table 2: Number of BSE cases in young bovine animals detected from January 2001 until December 2004 

Age group 
< 24 months 
24-29 months 
30-35 months 
36-41 months 
42-47 months 
Total < 48 
months 

2001 
0 
0 
0 
0 
3 
3 

Healthy slaughter 

2002 
0 
0 
1 
1 
0 
2 

2003 
0 
0 
0 
1 
2 
3 

2004 
0 
0 
0 
0 
5 
5 

2001 
0 
2 
0 
0 
5 
7 

Risk animals 
2003 
2002 
0 
0 
0 
0 
0 
1 
0 
1 
3 
1 
3 
3 

2004 
0 
0 
0 
0 
2 
2 

EN 

22 
EN 

 
 
 
Table 3: Number of test carried out from January 2001 until December 2004 per detected case 

Age group 

24-29 months 
30-35 months 
36-41 months 
42-47 months 
All ages 

Healthy 
slaughter 
No cases 
6.715.000 
1.532.500 
240.000 
34.743 

Risk animals 

177.500 
515.000 
310.000 
16.250 
1.572 

Table 4: Costs (Mio €) of BSE monitoring between January 2001 until December 2004 

The global costs of BSE testing is estimated at 40-50 € per tests with 45€ is taken as a mean cost 

Age group 

<24 months 
24-29 months 
30-35 months 
36-41 months 
42-47 months 
All <48 months 
All Ages 

Healthy 
slaughter 
152 
137 
302 
138 
108 
836 
1.612 

Risk animals 

3 
20 
29 
18 
15 
86 
223 

EN 

23 
EN 

 
 
 
  
  
  
Table 5: costs (Mio €) per BSE case detected between January 2001 until December 2004 

Age group 

<24 months 
24-29 months 
30-35 months 
36-41 months 
42-47 months 
All <48 months 
All =>48 months 
All Ages 

Healthy 
slaughter 
No cases 
No cases 
302 
69 
11 
64 
0,76 
1,56 

Risk animals 

No cases 
10,2 
29,5 
17,8 
0,9 
4,3 
0,04 
0,07 

EN 

24 
EN