Communication from the Commission to the Council, the European Parliament,the Economic and Social Committee and the Committee of the Regions - First bi-annual BSE follow-up report
Date: 1998-05-06
Institutions: European Commission
Subjects: animal disease, cattle, health legislation, veterinary inspection

COMMISSION OF THE EUROPEAN COMMUNITIES 

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Brussels, 06.05.1998 
COM(1998) 282 final 

COMMUNICATION FROM THE  COMMISSION 

TO THE COUNCIL, THE EUROPEAN  PARLIAMENT, 
THE ECONOMIC AND SOCIAL  COMMITTEE 
AND THE COMMITTEE OF THE REGIONS 

FIRST BI-ANNUAL BSE FOLLOW-UP REPORT 

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I. 

AVANT-PROPOS 

TABLE OF CONTENTS 

II. 

ACTION  UNDERTAKEN  BY THE  COMMISSION  CONCERNING  BSE/TSE  SINCE 
NOVEMBER  1997 

1. 

SCIENTIFIC  ASPECTS 

1.1.  Scientific  committees  : procedures 

• 

i) Nomination  of Scientific  Committee  members 

ii) Publicising the results of the scientific  committees 

iii) Acceleration  of payment  procedures for the members of the Scientific  Committees -  Payment 

of indemnity  of SC members 

1.2.  Scientific  advice 

i) Scientific  Steering Committee  to discuss list of Specified  Risk Material (SRM) and  abolition 

of age limits on exclusion  of younger animals 

ii) Meat and  Bone Meal (MBM): Safety  of inactivation  processes 

iii) Destruction  of MBM 

iv) Post mortem BSE tests 

1.3.  Research  activities 

i) Adoption  by the Commission  of projects  on TSE research  following  the 29tn  April  1997 joint 

call  for proposals 

ii) Organisation  and completion  of study of methods to establish quantity  and quality of  feed 

materials in compound  feedstuffs 

2. 

INSPECTIONS 

2.1.  Legal  framework 

i) Replacement  of two Commission  Decisions relating to performance  of on-the-spot  checks 

ii) Co-operation  with Member States (Directive 89/608/EEC) 

2.2.  The  Food  and  Veterinary  Office  (FVO) 

i) Receipt of,  and response to, IGS report 

ii) Recruitment  of staff  under the Supplementary  and Amending Budget (SAB)  1997  -

Additional  increase  in staff  numbers  in FVO 

iii) Development  of internal manual of procedures  by FVO 

2.3.  BSE  inspections 

i) Further  follow-up  missions concerning the reporting of all BSE cases 

(Germany,  Italy and Sweden) 

ii) Over Thirty  Months Scheme (OTMS inspection ( 9 - 11  February  '98)) 

3. 

IMPLEMENTATION  OF  COMMUNITY  LAW 

3.1. 

Taking  appropriate  action  pursuant 

to Article  169  of  the  Treaty,  where  the  UK 

failed 

to  apply  Decision  96/239/EC  and  Directive  64/433/EEC 

3.2. 

Implementation  of  Community  law/inspections/infringements 

with  regard  to  BSE: 

overall  situation 

3.3.  New  information  obtained  by  the  FVO  inspectors  with  regard  to 

implementation 

of  Decision  96/449/EC 

4. 

SITUATION  WITH  REGARD  TO  THE  UK  BEEF  BAN 

6 

7 

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IS 

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4.1. 

Submission 

to  the  European  Parliament  of  the  report  of  the  mission  to  the 

UK  9-  13.6.97 

4.2.  Appropriate  action  on  the  basis  of  scientific  advice  on  the  UK's  Export  Certified 

Herd  Scheme  (ECHS) 

4.3. 

The  UK proposal  on  a Date-Based  Export  Scheme  (DBES) 

4.4. 

Introduction  of  a  legal  requirement  for  traceability  of gelatine  and  certain  other 

products  made  in  the  UK from  non-UK  material  / Reinforcement  of  veterinary 

checks 

with  regard  to Decision  96/239/EC 

5. 

LEGISLATION 

5.1.  Co-decision  procedure 

5.2.  General  legislative  measures 

i) Assessment  of further  changes to Directive  85/374/EEC 

ii) Food  policy and the general principles of Food  Law 

iii) Completion  of simplification  exercise on food  hygiene legislation,  including veterinary  and 

phytosanitary  legislation 

iv) Entry into force  of regulation  EC/820/97 (beef labelling) 

5.3.  Reinforcement  of  controls  in  the  European  Union 

5.4.  Surveillance  and  control  of  communicable  diseases  and  other  health  issues 

i) Establishment  of a Community network  for the surveillance and control  of  communicable 

diseases and of an action  programme on rare diseases 

ii) Reinforcement  of the protection  of the health and safety  of workers from risks related to 

exposure to BSE and TSE agents at work by the adoption  of Directive 97/65/EC 

iii) Proposal  on effective  surveillance of TSEs in animals in the Member States 

5.5.  Exclusion  of  risk  material  from  the food  and feed  chain 

i) Commission  consultation  paper on exclusion  of high risk material  from  the feed  chain and 

on a ban on feeding  animal protein to ruminants 

ii) Adoption  of a feed  ban on MBM not produced  in accordance with the standards of 

Decision  96/449/EC  and restriction  on use 

iii) SRM: Proposal to exclude specific  hazardous materials from  the human or animal  food  chain 

iv) Labelling of compound  feedingstuffs 

v) Destruction  of MBM / Landfill 

: 

6. 

INTERNATIONAL  ASPECTS 

6.1.  Participation,  collaboration 

and  membership  of  the  Commission 

in 

international 

organisations 

6.2.  MBM  safety  standards  + general  standards 

in  the  OIE 

6.3.  Hormones,  feedingstuffs  additives 

7. 

NVCJD  VICTIMS:  CURRENT  SITUATION  AND  ASSISTANCE  TO  NvCJD  VICTLMS 

ORGANISATIONS 

7.1.  Current  situation  regarding  CJD  and  nvCJD  cases  in  the  EU 

7.2.  Assistance 

to  nvCJD  victims  organisations 

8. 

FRAUDS  AND  FINANCIAL  ASPECTS 

8.1.  Fraud:  co-ordination 

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8.2.  Financial  consequences from findings  on the Over Thirty Months Scheme  (OTMS) 

and the selective  cull scheme, should there be justifications  of failures  by the UK 

authorities  to respect  Community Regulations 

III.  ANNEXES 

ANNEX  1A:  JOINT CALL FOR PROPOSALS ON TSE 

ANNEX  IB:  RESEARCH  THEMES 

ANNEX  2A:  SUMMARY  AND CONCLUSIONS  OF MISSIONS  TO ALL MEMBER  STATES  IN 1997 

REGARDING DECISION 96/449/EC 

ANNEX  2B:  ANIMAL  WASTE LEGISLATION-  WORKING  PROGRAMME  1998 

ANNEX  3: 

CURRENT  SITUATION  REGARDING  CJD  AND NVCJD  CASES IN THE EU 

ANNEX  4: 

LIST OF THEMES COVERED BY THE PRESENT  REPORT  IN THE  LIGHT OF THE  "BÔGE 

REPORT" OF THE EUROPEAN  PARLIAMENT,  IN ADDITION TO THE ACTION  PROMISED 

IN  DOCUMENT C O M ( 9 7)  5 09  FINAL 

44 

46 

46 

49 

51 

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57 

64 

I. 

AVANT-PROPOS 

On 20 October  1997, the Commission presented its final  consolidated report to 
the Temporary  Committee of the European Parliament on the Follow-up  of 
Recommendations  on BSE (COM(97) 509 final)  to the European  Parliament 
and to the Council. The report described major  achievements realised  in the 
field  of food  safety  and consumer protection and important developments in 
the fight  against BSE since February  1997. 

The Commission was however fully  aware of the need for further  action in 
addition to the initiatives taken between February and October  1997. By 
presenting its final  consolidated report, the Commission  consequently 
announced  an ambitious work programme and indicated that further  progress 
would be reported twice a year to the European Parliament and the Council. 
Furthermore, a common conference  will be organised before the end of  1998 
by the Commission and the European Parliament with a view to taking  stock 
of the situation in a future-oriented  perspective. 

The present first  bi-annual BSE follow-up  report informs  the European 
Parliament and the Council of the state of implementation of this work 
programme. In addition, the report describes developments  concerning 
questions which are of particular concern for the European Parliament, as 
reflected  in the report presented by Mr Bôge, which the European  Parliament 
adopted during its plenary session of  19 November  1997  l.  In this context, the 
Commission  confirms  that it shares the European Parliament's view that the 
improvement  of food  safety  and the restoration of major  consumer  confidence 
must be a major  target of the reform  of the Common Agricultural Policy as 
recently presented  in the Agenda 2000 proposals, in addition to the measures 
described in the present  communication. 

As already underlined  in the October  1997 report, the Commission  believes 
that consumer confidence  can only be restored through a close co-operation 
between the European Parliament, the Council and the Commission  and the 
Member States on the basis of a permanent commitment  to the objective  of 
protecting the consumers' health. 

By adopting a declaration on food  safety  at its meeting of  12-13 December 
1997 in Luxembourg, the European Council underlined that "food  safety  is 
more than ever a matter of major  concern for the public, and everything  must 
be done to restore public confidence  severely shaken by the BSE crisis" and 
"welcomed  the Commission's  undertaking to submit twice-yearly reports on 
BSE to the European Parliament  and the Council". 

The Commission  invites the European Parliament  and the Council to take note 
of the present  report. 

In parallel  to the present  report,  a BSE vademecum for consumers  is being prepared  for  the general public. 
Before  its finalisation,  clarifications  were awaited  on the following  questions : 
- the scientific  evaluation of the safety  of certain products (tallow,  gelatine, ...); 
- the lifting  of the embargo with  regard  to the Export  Certified  Herds Scheme  in Northern  Ireland; 
- the definition  of the measures to be taken with respect to SRM. 

Work has now been accelerated  with a view to publishing the Vademecum before  the end of July  1998. 

6 

II. 

ACTION UNDERTAKEN  BY THE COMMISSION  CONCERNING 
BSE/TSE SINCE NOVEMBER  1997 l 

1- 

SCIENTIFIC  ASPECTS 

1.1. 

Scientific  committees  : procedures 

i) 

Nomination  of Scientific  Committee  members 

With Commission Decision of 5 November  1997,  132 members of the 
Scientific  Committees (SC) have been nominated, following  a selection 
process on which the EP was kept fully  informed. 

ii) 

Publicising the results of the scientific  committees 

All scientific  opinions and minutes of the meetings of the  scientific 
committees and the scientific  steering committee are published on the 
INTERNET  as soon as the responsible committee adopts them as final. The 
Scientific  Steering Committee (SSC) has recently published some preliminary 
opinions by this way, inviting comments which then had been taken into 
account before  finally  adopting the opinions. A brochure presenting the 9 
committees is in preparation. It is planned to publish the available opinions in 
form  of a series of booklets. 

iii) 

Acceleration  of payment procedures for the members of the  Scientific 
Committees -  Payment of indemnity of SC members 

A serious problem remains concerning the payment system. Thus there is still 
a large backlog of reimbursement  of the travel and subsistence expenses of 
members of the scientific  committees. 

Nevertheless, in April  1998 an important  specific  effort  has been made to clear 
the backlog and there is a commitment  that a significant  acceleration of the 
reimbursements will take place. The aim is to ensure that  reimbursements 
arrive on the accounts of the experts no later than 2 months after  the meeting. 

As regards the indemnity payment, the Commission has decided in agreement 
with the scientific  committees to make this by 3 payments per year, covering 

The present  report describes the action promised  by the Commission's  final  consolidated  report to the 
Temporary  Committee of the European Parliament on the follow-up  of recommendations  on BSE (COM(97) 
509final)  and additional  questions covered  in the light of the "Bôge report" of the European Parliament  (see 
also annex 4 of the present  report). A special  report concerning  recommendations on BSE was presented by 
the Commission  to the European Parliament  and the Council by the end of January 1998. 

7 

meetings held in the period November to February, March to June, and July to 
October. The payments for the first period are now underway. 

1.2. 

Scientific  advice 

i) 

Scientific  Steering Committee to discuss list of Specified  Risk Material 
(SRM) and abolition  of age limits on exclusion  of younger  animals 

The SSC was requested to continue the work started by the Multidisciplinary 
Scientific  Committee (MDSC) and adopted on 9 December  1997 an opinion 
on SRMs in which it proposed  a list of tissues that should be classified  as 
SRM. In establishing this list, the SSC took account of the relative  infectivity 
of the respective tissues in infected  animals but also took into account the 
species and age of animals. In further  opinions of 26-27 March  1998, the SSC 
concluded that this list may be modulated on the basis of a risk assessment 
which takes into account the geographical origin of the animals, their species 
and their ages. 

On 23 January  1998 the SSC issued an opinion on that geographical risk. It 
defined  three risk elements and concluded that it should be possible to assess 
the geographical risk if sufficient  data were available. It also specified  an ideal 
set of data and undertook to carry out a regional risk assessment  as soon as 
appropriate data would be available. 

On 20 February  1998 the SSC issued several preliminary opinions which 
where open for comments by any interested party until  16 March  1998. In its 
final opinions adopted on 26 March  1998, the SSC took account of the 
comments  received.. 

In an attempt to establish a comprehensive analytical framework,  one of these 
opinions addressed the BSE-risk in general. The SSC recognised  three  major 
issues, namely the risk for humans from direct and indirect consumption  of 
potentially infective bovine material and the risk of propagating the disease by 
recycling the infective  agent via the animal feed  chain. 

As SRMs are identified  as key factors  in assessing these risks, the SSC 
presented  a table of the relative infectivity  of suggested SRMs from an 
infected  bovine (data provided by SEAC, Feb.  1998). This table shows that the 
brain and the spinal cord of an infective bovine together represent  89.6% of 
the total infective  load of such an animal. The trigeminal and dorsal root 
ganglia represent 6.4% and the ileum another 3.3%. Excluding these six 
tissues would reduce the infective  load entering the food  and feed  chains when 
such an animal is slaughtered by 99.3%. The SSC also confirmed  its list of 
SRM presented on 9 December  1997 but added that lungs should not be 
regarded  as SRM if suitable slaughtering procedures are in place. The SSC 
also clarified  that it would not be necessary to exclude the entire intestine if 
separation of the ileum from the rest proves to be practical. 

The SSC re-affirmed  that the presence of BSE in sheep and goats is possible 
but not confirmed.  It nevertheless insisted that certain parts of these animals 
should be classified  as SRM (head, spinal cord of animals older than  1 year 
and spleen and distal ileum at all ages). 

Concerning the age limit, the SSC did state in its opinion of December 1997 
that animals under  12 months of age do not carry any SRM other than the 
intestine (now reduced to the ileum) and the spleen (only ovine and caprine). 
The reason being that the infective  load seems not to be likely to reach a 
critical  level before  that age, even if infection  would have taken place at birth. 

ii) 

Meat and Bone Meal (MBM): Safety of inactivation  processes 

The SSC has been working on an opinion on the safety of MBM since October 
1997. Intensive discussions took place between Prof. Taylor and other 
experimental  researchers in this field and Prof. Riedinger, who based his 
arguments on an analysis of available literature data and an extrapolation  from 
microbiological  infections  to BSE. 

The debate can be summarised as follows: The experimental data seem to 
indicate an efficiency  of the inactivation process of 10"2 to 10"3. The calculation 
of Riedinger seems to indicate that a reduction by 10"6 is realistic (even up to 
10"9). However, the latter values are only possible if clearly defined  conditions 
are perfectly  respected. 

The SSC came therefore to the conclusion that in high risk countries no MBM 
should be produced from ruminants with the aim to feed it to any mammalian 
animal. 

In countries with a lower risk, safety  of MBM could be reached by respecting 
the necessary process conditions and suppressing  SRMs. 

In countries without a BSE risk or where the risk is considered negligible, 
MBM could be safely produced by any method. However, as a precautionary 
measure the SSC recommends also in these cases certain actions to eliminate 
the remote risk that spontaneous cases might occur. 

iii) 

Destruction  of MBM 

This question is included into a more general one currently addressed by the 
SSC  concerning the safe disposal of animals and animal tissues  assumed to 
carry a risk of being  infected  with BSE (SRM). An opinion is envisaged for 
June or July. 

iv) 

Post mortem BSE tests 

A group of experts from  inside and outside the Commission  Services visited 
two companies, which claimed early in 1998 to have a BSE-test. They 
reported positively on the perspectives but added that there could be no 
guarantee that either of these tests could finally be developed up to an extent 
that it could be used for official  purposes. As a result the Commission has 
launched a procedure to validate such tests. Any provider of a test is invited to 
participate in that validation procedure. First results are hoped for end 1998. It 
is worth noting that in the meantime the Commission has become aware of 
other tests  approaching "applicability, which have not been validated  either. 

In this context the Joint Research Center (JRC) has an important role to play as 
it can provide support to the Commission in some important tasks related to 
the possible validation of the two available post-mortem BSE  diagnostics 
methods, in particular  as regards the handling and codification  of samples, the 
critical assessment of results and the preparation of a final report. The JRC will 
work closely with other Commission services such as DG XXIV, DG XII, DG 
VI and DG III to ensure an appropriate planning  and co-ordination  of logistic 
aspects. 

Within the Community research programmes BIOMED, BIOTECH and FAIR 
the Commission  is funding  or in the process to fund  9 projects  on diagnostic 
issues for human and animal TSE. These projects  intend to evaluate the 
effectiveness  of different  markers (cerebrospinal  fluid,  specific  antibodies, 
specific  proteins) or methods (use of transgenic animals, magnetic resonance, 
cultured cells) as potential diagnostic tools for in vivo and in vitro diagnosis. 

1.3.  Research  activities 

i) 

• 

Adoption  by the Commission  of projects on TSE research following  the 
29th April  1997 joint call for proposals 

First joint  call for proposals  in the field  of transmissible  spongiform 
encephalopathies 

The  1st Joint Call for proposals on research in the field of transmissible 
spongiform  encephalopathies (TSE) was launched by the Commission on 
29 April  1997 in the framework  of its three Community research  programmes 
on Life  Sciences and Technologies (BIOMED, BIOTECH and FAIR) as part 
of the Action plan for Research on TSE. 

The call included six main research themes: 

1. 

2. 

3. 

4. 

5. 

6. 

clinical, social and epidemiological research on human  spongiform 
encephalopathies (SEs); 

the infectious  agent and its transmission mechanisms; 

diagnosis of SEs; 

risk assessment  of SEs; 

treatment and prevention of SEs; 

co-ordination of research activities between Member States. 

This call attracted a wide response from the scientific  community and an 
excellent mobilisation of expertise from most Member States. Altogether, 
66 proposals (39 in BIOMED,  15 in BIOTECH and  12 in FAIR)  involving 
308 laboratories were received. 

10 

Following an evaluation of the scientific  and technical quality of the projects 
as well as their impact on ethical terms, carried out by the  Commission 
assisted by independent  experts, 22 proposals were considered to be of 
excellent quality and therefore  worthwhile to deserve funding.  The 
distribution of proposals among the three research programmes was  12 in 
BIOMED, 7 in BIOTECH  and 3 in FAIR. 

Following the unanimous positive opinion of the three programme  committees 
concerned, the Commission  adopted on the  16 February  1998, 22 projects  for a 
total amount of 21.9 Million ECU. A detailed description of the projects  is 
shown in Annex  1 A. 

These projects will be financed  as a result of the decision taken by the 
European Parliament  and the Council of Ministers on  1  December  1997 on the 
financial  complement to the 4th Framework programme which raised by 
115 million ECU the total budget for European Union research  programmes 
including 35 million ECU for TSE research. 

A particularly  attractive characteristic of these projects  is their combination  of 
widely separate but nevertheless complementary  skills (e.g. structure of 
proteins, tissue culture, epidemiology,  etc) through the joint development  of 
specialised  teams some of which have had no prior involvement  in the TSE 
field, maximising the chances of achieving results. 

The adopted projects  strengthen and complement the ongoing research  in this 
field within these programmes and will also allow the development  of a 
comprehensive research effort  on issues which can be considered  as a pre 
requisite  for a proper risk assessment, namely: 

European epidemiology, aimed at ensuring, on a harmonised  scale, the 
identification,  comparison and epidemiological  surveillance of TSEs 
both in humans and in animals; 

identification  of the agent(s) responsible for TSEs, with a view to 
determining its principal characteristics  and transmission  mechanisms; 

development  of diagnostic tools, using techniques such as magnetic 
resonance, electroencephalography  and use of specific  antibodies; 

risk assessment, notably with regard to risks associated with the 
consumption  of livestock products and with blood  transfusions; 

therapeutic  and preventive strategies, the examination of the properties 
of certain families  of substances with a view to determining  their 
suitability as therapeutic agents; 

co-ordination  of the research activities of the Member States, with the 
development  of the first network comprising  11 Member States for the 
epidemiological  surveillance of scrapie and the establishment  of a 
common scientific  database on scientific  research and public  decision 
making on TSE. 

11 

• 

Specific call for proposals for the FAIR  programme 

This call for proposals was implemented by means of an internal 
redeployment within the FAIR programme, freeing ECU 8.8 million. The 
contracts corresponding to the eight projects  selected last year have been 
drawn up. Five have already been signed, and the other three are about to 
be. This research work, announced in the previous report in autumn  1997, 
is therefore  now under way. 
Full information  on these projects, and on all other research  projects 
administered by DG VI in the area of TSE under the FAIR, AIR and 
CAMAR programmes, can be accessed on the DG VI Internet  server 
(address: http://europa.eu.int/en/comm/dg06). 

• 

Launching  of the 2nd joint  call for proposals  in the field  of TSE research 

On 28 January  1998, the Commission organised  a workshop  in the area of TSE 
risk assessment with a view to the launching of a 2nd joint call for proposals in 
the field of TSE research which would tackle in a more focused  way  further 
issues in this area. 

This workshop, attended by leading independent  experts in the field, aimed at 
reviewing the existing knowledge and at identifying  research priorities in this 
area. 

The 2nd joint call for proposals within the research programmes BIOMED, 
BIOTECH  and FAIR was launched on  17 March  1998 and will include 3 main 
research themes based on the experts'  recommendations: 

1. 

risk 

assessment of SEs; 

2. 

3. 

treatment  and prevention of SEs; 

co-ordination  of research activities between Member States. 

The deadline  for submission of proposals is  17 June  1998. A detailed 
description of the research themes is shown in Annex  IB. 

ii) 

Organisation  and completion  of study of methods to establish  quantity 
and quality  of feed materials  in compound  feedstuffs 

A validation  study on two analytical methods concerning BSE  is being  carried 
out by the JRC-Environment  Institute (also with the participation  of the 
Institute  for Reference  Materials and Measurements) with funding  from 
DG XXIV.  The following  two validation methods will be  investigated: 

12 

Validation of a method for the detection of the appropriate  heat treatment of 
animal  meals 

The detection of an appropriate heat treatment of animal meals (20 minutes at 
133°c at 3 bars) in the context of the Decision  96/449/EC will be  investigated. 
An appropriate heat treatment  is not always guaranteed because of the  different 
technical installations  for heat treatment that are in use in the Member  States. 
There is, therefore,  a need for a suitable method able to detect compliance with 
requirements in the above mentioned Decision, and to allow to determine 
clearly whether or not animal meals have been thermally treated according to 
the Decision; 

A recently developed method based on an ELISA (Enzyme Linked 
Immunosorbent  Assay) technique will be validated on an international  level by 
JRC in order to demonstrate the general suitability of the method  (a negative 
result of the ELISA test indicates a properly heat treated animal meal). 

The delivery of results of the validation is foreseen  for the end of  1998.  In 
addition, "reference" animal meal samples (heat treated under various 
conditions) will be produced and will be made available to the public  after  the 
validation  study. 

Detection  of mammalian  meals in feedingstuff  of plant  origin 

The detection of mammalian meals in feedingstuff  of plant origin will be 
investigated. In the context of BSE, the source of mammalian  feedingstuff 
should be known  and labelled correctly.  Therefore  validated methods  are 
needed  in order to prove the absence or presence of mammalian meals in 
feedingstuff.  The method to be validated by JRC is the one based on 
mitochondrial  DNA  determination. 

The delivery of results of this validation is foreseen  for the end of 
1998/beginning of  1999. In addition, JRC will prepare the reference  material 
samples of relevant  feedingstuff. 

These detection methods could be extended to investigate the presence of meal 
from  other animal species. 

Method  based on DNA analysis 

The presence of mammalian meals in feedingstuffs  of plant origin can be 
detected by determination of animal DNA. The method of choice should  allow 
to detect bovine material in meals even at a level of about 0.1 % in 
feedingstuff.  However, when the mammalian meals added to the  feedingstuff 
have been heat treated according to the Decision 96/449/EC there is most 
probably only a small chance that the mammalian DNA is still detectable. 
Therefore,  other methods based on microscopy, immunoassay or 
spectroscopies  should be also investigated  and validated by JRC in the  future. 

13 

The JRC  intends to carry out the following  three studies, after  the validation of 
the above mentioned two methods are completed: 

Methods  based on microscopy 

At least two microscopic method approaches are already available in the 
European  Union. The JRC will propose to validate both microscopic methods. 

Method  based on ELISA  technique 

This ELISA test for the detection of ruminant  and porcine heat stable proteins 
in compound  animal feedingstuff  has been already validated within the United 
Kingdom. Contacts have already been taken between the JRC and those 
responsible for the UK validation study, in order to collaborate on a validation 
study on a European level. 

Development  of rapid screening methods 

The JRC wishes to start research on the possibility to use the Fourier 
Transform  - Near Infrared  (FT-NIR) spectroscopic method and the  Differential 
Scanning Calorimetry (DSC) technique as rapid methods for the detection of 
animal proteins in compound  feedingstuff.  The experimental work could be 
initiated  in 1998. 

The Commission  will take account of these results with the aim of drawing up 
a draft  amendment  to Council Directive 70/373/EEC on the introduction of 
Community methods of sampling and analysis for the official  control  of 
feedingstuffs. 

2. 

INSPECTIONS 

2.1. 

Legal  framework 

i) 

Replacement  of two Commission  Decisions  relating to performance  of on-
the-spot  checks 

The following  Commission Decisions were published  in Official  Journal L 38, 
of  12 February  1998: 

Commission Decision  98/139/EC of 4 February  1998 laying down  certain 
detailed rules concerning on-the-spot checks carried out in the  veterinary 
field  by Commission experts in the Member  States. 

•  Commission Decision  98/140/EC of 4 February  1998 laying down  certain 
detailed rules concerning on-the-spot checks carried out in the  veterinary 
field  by Commission experts in third countries. 

These Decisions replace existing Community  legislation  in this  field,  and have 
the following  main  effects: 

14 

a reduction in the time allowed to the Commission to despatch its mission 
findings  to the country concerned from 2 months to 20 working days; 

a reduction  in the time allowed to Member States to respond  to mission 
findings  from  2 months to 25 working days. The same provision will be 
applied administratively to third countries; 

where an emergency health risk has been identified,  the above  exchanges 
must take place as quickly as possible. A maximum period of  10 working 
days is allowed for the Commission to despatch its report, and the same 
period  for the Member State to respond; 

the findings  of inspections and any recommendations  for action will be 
made available to the European Parliament and to the public, subject  to 
the need to respect the provisions of Article 214 of the Treaty of the 
European  Community; 

account is taken of the potential impact on the organisation and 
performance  of control missions in the context of agreements between the 
European  Community  and third countries on sanitary measures  applicable 
to trade. 

ii) 

Co-operation  with Member States (Directive 89/608/EEC) 

•  Application  of Directive  89/608/EEC 

In application  of article 9 (2) of Directive  89/608/EEC the  Commission's 
services (DG XXIV) on 3 April 98 informed  the veterinary  authorities of all 
Member States about severe irregularities which were revealed during FVO 
inspections to Member States. The practices observed were undermining the 
traceability of meat. Basic principles of n;eat trade in the Community  were 
disregarded  and thereby fraudulent  international  trade  facilitated. 

The veterinary services were asked to give priority to the official  controls on 
identification  of fresh  meat, documentation  of trade and the performance  of 
self controls by the industry, as foreseen  by Community  legislation. In 
accordance with article  11 of Directive  89/608/EEC  further  discussions of the 
issue with Member States will take place in the Standing  Veterinary 
Committee when the reports of the above mentioned missions will be 
presented. 

•  Amendment  of Directive  89/608/EEC, where necessary, and  reinforcing 

controls when emergency measures apply 

These questions were dealt with in the special report to the European 
Parliament  concerning recommendations  on BSE. 

15 

2.2.  The Food and Veterinary Office  (FVO) 

i) 

Receipt of,  and response to, IGS report 

The Commission communication to the European Parliament  and the Council 
on food, veterinary and plant health control and inspection 
(COM (1998) 32fmal)  provided the response to the IGS report. 

The Commission  fully  endorsed the recommendations made in this report> In 
particular, it has decided that its control and inspection responsibilities  will 
continue to be undertaken by the FVO, under the overall responsibility  of the 
Commission, rather than being assumed by an external Agency. 

The IGS report  fully  supported the introduction of the new working 
procedures, originally described in the earlier Commission communication  on 
consumer health and food  safety (COM(97)  183final). The action necessary to 
introduce these changes is in hand within the FVO. 

It should be noted that following  the conclusions of the European Council of 
October  1993, the Commission has moved the Food  and Veterinary  Office  to 
Ireland on  1 September  1997. Experience has begun to indicate that the 
establishment  of the Office  in Ireland poses certain operational and  financial 
difficulties. 

ii) 

Recruitment of staff under the Supplementary  and Amending  Budget 
(SAB)  1997 -  Additional  increase in staff numbers in FVO 

As indicated in the Commission communication to the European Parliament 
and the Council on food, veterinary and plant health control and inspection 
(COM(1998) 32 final), the Commission is taking action to fill the  166 extra 
posts identified  by the IGS report (SEC(97) 482/3) of  11 March  1997 as being 
necessary for its control services to meet their commitments. 

35 additional posts were made available under the SAB  1997.  All of these 
have now been filled. 99 posts and credits for  12 auxiliaries have been 
allocated in the  1997 and  1998 allocation procedures both through 
redeployment  (66) and by allocating new posts (33). 

Altogether,  146 of the  166 necessary extra posts identified  in the IGS Report 
have thus been made available and will be filled in  1998.. The remainder 
(around 20 posts) will be made available in the  1999 allocation of resources. 

Several selections for the recruitment  of temporary  agents  have been 
organised  and completed.  The remaining candidates on. existing  competition 
reserve lists have been recruited to the maximum extent possible.  Of the two 
competitions  launched  last summer for veterinary, phytosanitary  and other 
food  experts, one (at the A5/A4 level) is completed  and recruitments  are 
beginning  from  the reserve list; while the other (at the A7/A6 level) will be 
completed  in June  1998. For the last 20 posts for  1999, it is also intended to 
begin the recruitment procedures in  1998. 

16 

The recruitment  exercise has made major training efforts  necessary. These 
have been initiated in particular with regard to audit procedures. 

iii) 

Development  of internal manual of procedures by FVO 

An initial manual of operations has been prepared, and is now in use by the 
FVO. In particular this covers the planning, performance  and reporting 
procedures for control and inspection missions. It allows a standardised 
approach to be adopted to the manner in which these activities are undertaken. 
This document represents an important first step towards the final adoption of 
the complete manual of procedures, which will also include  standardised 
formats  for reports and other documents, as well as detailed rules for the 
performance  of audits. 

2.3. 

BSE  inspections 

i) 

Further follow-up  missions concerning the reporting of all BSE cases 
(Germany, Italy and Sweden) 

The results of these missions were summarised in the Special Report to the 
European Parliament concerning recommendations on BSE. 

ii) 

Over Thirty Months Scheme (OTMS inspection  ( 9 - 11  February  '98)) 

A joint mission to inspect the implementation of the scheme for slaughter and 
destruction of bovines over thirty months of age was undertaken by inspectors 
of the Clearance of Accounts Unit of DG VI and the FVO from 9 to 
11 February  1998.  Priorities of the mission were measures to avoid material 
from  these animals to enter the food  and feed chains.  Improvements have 
been noticed since the previous missions.  However,  some  further 
improvement  is still required in the context of slaughtering bovines under the 
rules of the OTMS. 

The draft  report has been sent to the UK authorities for comments.  The final 
report will be submitted to the European Parliament and to the  Standing 
Veterinary  Committee. 

3. 

IMPLEMENT A TION OF COMMUNITY LA W 

3.1. 

Taking  appropriate  action pursuant to Article 169 of the Treaty, where 
tHëUK failed  to apply Decision 96/239/EC and Directive  64/433/EEC 

Following  intervention from the Commission the United Kingdom  adopted 
during August and September  1997 new national rules to better provide for the 
imposition  and enforcement  of the export ban imposed by  Commission 
Decision 96/239/EC  as amended. Administrative circulars governing the 
enforcement  of the new  legislation  have  also been  supplied.  The  competent 

17 

Commission  services concluded on 29 October  1997 that the  legislative 
measures were now generally adequate.  Need for improvement with regard to 
the practical  enforcement  at some ports has been  identified  in the report of the 
FVO mission from 29 September to 3 October  1997. 

• 

In respect of insufficient  controls at meat plants involving  alleged 
breaches not only of General Community Veterinary and Public Health 
Legislation under Council Directives 64/433/EEC and 89/662/EEC but 
also the BSE export ban imposed by  Decision 96/239/EC the 
* 
Commission opened an Article  169 procedure by letter dated 
22 September  1997. 

As the United Kingdom reply of 20 October  1997 was not considered to 
constitute a legal justification  for the inadequacies noted in the FVO 
report the Commission decided to send the Reasoned  Opinion. 

On  2 April  1998 the UK submitted  a document outlining  improvements 
in the level of supervision in meat plants in Great Britain and initiatives to 
move towards compliance with EC rules. Commission services have 
considered the technical and legal implications of this document. 

•  Another issue considered in this context is the notification  sent to the 
Commission by the Dutch authorities concerning the presence on the 
Dutch market of beef consommé and similar products seized in the 
Netherlands. 

In the framework  of the Rapid alert system, the Commission  services 
recently forwarded  this notification  to all Member States. These  foodstuffs 
fall undoubtedly under Article  1 of Decision 96/239/EC.  The UK 
authorities are still investigating this. However it is still unclear whether 
these products were prepared from bovines slaughtered outside the United 
Kingdom. The same products were also withdrawn from the Canadian 
Market. 

3.2. 

Implementation  of Community law/inspections/infringements  with  regard 
to BSE: overall  situation 

a) 

Community law obligations with regard to BSE 

The respect by the Member States of their Community law obligations with 
regard to BSE has been subject to strict monitoring by the  Commission 
services. New results of inspections in Member States have been  carefully 
examined in respect to possible infringements  of Community  law. 

In cases where it has been established that national law and  administrative 
practices within a Member State did not reflect  that Member  State's 
obligations or that the Member State concerned failed to enforce the applicable 

18 

legislation within its territory the Commission has intervened with the Member 
State in order to ensure compliance. 

In cases where early voluntary compliance by a Member State has not 
followed  the Commission's  intervention, infringement  proceedings under 
Article  169 of the EC Treaty have been opened. 

Thus, on 26 June  1997 the Commission decided to open  infringement 
proceedings against ten Member States in respect of their apparent  failure  to 
enforce  some aspect of Community legislation concerning BSE. The  subject 
matter of these initial proceedings concerned principally  inadequate 
implementation  of Commission Decision 96/449/EC (heat treatment  system 
for processing animal waste) and failure to sufficiently  control the respect of 
Commission  decision 94/381/EC prohibiting "the use of mammalian tissues in 
feeding  stuffs  destined  for ruminants. 

In addition, in the light of the results of the new FVO inspections carried out in 
the second half of  1997, relating primarily to the application of Decision 
96/449/EC, new infringement  proceedings were launched on 25 March  1998 
against two other Member States. 

The Commission regards the meticulous implementation  of both these texts as 
vital if BSE is to be eradicated  and the possible risks to human health pending 
eradication are avoided. In this respect, it should be noted that the  Commission 
is now making full  use of the internal reforms  decided in July  1996 to speed up 
the Article  169 procedures: infringement  cases ready for a decision, in 
particular those concerning BSE, are now handled on a bi-monthly basis, 
which leads to increased interventions with the Member States. In addition, 
time limits granted to Member States for replying to the letters of  formal 
notice or the reasoned opinions have been sharply reduced (to  15 days only). 

b) 

The Member States concerned by the infringement  procedures  mentioned 
above are as  follows: 

1.  France 

France failed  to implement Decision 96/449/EC on the grounds that it disputed 
the efficacy  of the technical parameters  for processing animal waste  imposed 
by the decision and questions the legal basis on which the text was  adopted. 

The Commission decided on 26 June  1997 to open an infringement  procedure. 
Following the dispatch by the Commission of a letter of formal  notice on 
7 July  1997 and a Reasoned Opinion on 22 December  1997 the French 
Government  communicated  on 9 March  1998 the text of an arrêté ministériel 
of 6 February  1998 providing for obligatory treatment of animal waste in 
accordance with Commission Decision 96/449/EC. 

2.  Belgium 

The OAV inspection visit in November  1996 brought to light shortcomings  in 
the system for monitoring the application of Decision 94/3 81/EC (feed ban), 
particularly the lack of sampling for microscopic analysis of ruminant  feed at 
various stages of the process (production, marketing, use). 

19 

On 26 June  1997, the Commission decided to commence  infringement 
proceedings. Following the sending of a letter of formal notice on 7 July  1997 
and subsequent  correspondence, the Belgian authorities  agreed to  supplement 
their programme of administrative and accounting controls with microscopic 
analyses of samples of ruminant  feed taken at different  stages of the process 
(107 analyses in  1997)'. 

In addition, following  the finding  during the FVO visit on  18 September  1997 
of defects  in the system for monitoring the application of Decision  96/449/EC 
in Belgium, the Commission has decided to commence new  infringement 
proceedings. 

3.  Luxembourg 

The infringement  procedure against Luxembourg begun on 26 June  1997 was 
targeted initially at the shortcomings in the system for monitoring the 
application of Decision 94/381/EC highlighted by the FVO inspection visit on 
23 November  1996, in particular the lack of sampling for  microscopic 
analysis of animal feed  at different  stages of the process, and secondly at 
integrating Decision 94/3 81/EC into Luxembourg national  legislation. 

In response to the letter of formal  notice of 7 July  1997, the Luxembourg 
authorities established  a programme for taking 40 samples per year of 
ruminant  feed  for analyses relating to the entire process (see (1)). 

In addition, the Luxembourg authorities have transposed Decision 94/381/EC 
into national law. 

4.  Netherlands 

A veterinary inspection mission took place in December  1996. Failure to 
complete approval of all plants processing animal waste and failure  to provide 
a list of all plants concerned and also incomplete implementation of Decision 
96/449/EC motivated the Decision on 26 June  1997 by the Commission to 
open an infringement  procedure and the dispatch of a formal notice on 7 July 
1997.  At present the only remaining problem concerns the approval of 6 low-
risk establishments which do not meet certain housing requirements  laid 
down in the relevant EC rules. 

5.  Germany 

Following  a veterinary mission in November  1996, a decision to open an 
infringement  procedure was taken on 26 June  1997 and a formal  notice was 
sent on 7 July  1997 for the following  reasons: 
failure  to implement Decision 96/449/EC  as far as particle size parameter is 
concerned; 

The  Commission  services  are  looking  into this programme  and  also exploring  the  manner  in which  to 
adopt  a legal  instrument  providing  for  a control  system  to properly  enforce  Decision  94/381/EC  (see 
under  point  5.3:  reinforcing  routine controls  in animal  feed). 

20 

also national exemption from the requirements of processing under Decision 
96/449/EC  of certain by-products used for animal feed of processing  material 
fit for human  consumption. 
With regard to the first complaint, the German authorities have complied by 
amending the Regulations concerning rendering plants. With regard to the 
interpretation  of the derogations set out in Article  1(2) of Decision 
96/449/EC, Germany maintained its original position. In the light of this 
situation, the Commission has decided to propose to the Standing  Veterinary 
Committee a clarification  of the texts of Decision 96/449/EC  in question. 

6.  Spain 

An infringement  procedure was decided on 26 June  1997 and a letter of 
formal  notice was issued on 7 July  1997, based on a FVO mission in October 
1996, for the following  reasons: 

Risk material considered as low risk processed into animal feed without  being 
treated in accordance with the parameters of Decision 96/449/EC; 

Enforcement  of feed ban imposed by Decision 94/3 81/EC is inadequate, 
because no official  analysis of feed  to detect mammalian Meat and Bone meal 
is made; 

Spain failed  also to ensure that a waste processing plant had its processing 
procedures validated  as required by Community  Legislation. 

A Reasoned opinion has been issued on 3 February  1998. As a result of a 
further  inspection in October  1997, it appeared that the Spanish  authorities 
changed their position on the first point and consider that Decision  96/449/EC 
does apply to low risk material within the meaning of Council  Directive 
90/667/EEC. With regard to the problem of the enforcement  of the feed  ban, 
the Spanish authorities stated in their reply to the Reasoned opinion, that they 
are improving their programme of control, which is under analysis by the 
Commission  services (see footnote  (1)). Concerning point 3, the Commission 
considers that further  examinations will be required to ensure the complete 
conformity  of the Spanish plants with the validation process. 

7.  Sweden 

A veterinary inspection mission in November  1996 established that  Sweden 
failed  to transpose Article 3(2) of Directive 90/667/EC by the due date and 
also to officially  approve rendering plants as required by Article 4(1) of 
Directive 90/667/EEC. 

Commission's  interpretation  of Decision 96/449/EC as far as processing of 
bones fit for human consumption into animal feed  is disputed by Sweden. 

Sweden's  enforcement  of the ban under Decision 94/381/EC of incorporating 
mammalian material in ruminant  feed  is considered inadequate in so far  as the 
Swedish control regime only envisages annual analysis of  100 samples. 

21 

A letter of formal  notice was issued by the Commission on 7 July  1997  after 
the Commission decided to open an infringement  procedure on 26 June  1997. 

A veterinary inspection mission carried out in Sweden from  24 to 
28 November  1997 confirmed  régularisation of the first two previous 
grounds. 

The Commission  intends to modify  Decision 96/449/EC in such a way that it 
clearly reflects  the Commission's  construction thereof. 

The Commission  services have been supplied with information  to the  effect 
that the Swedish administration  foresees  to take 200 samples in the course of 
1998 (see footnote (1)). 

8.  Finland 

*• 

The Commission took the decision on 26 June  1997 to open an  infringement 
procedure and issued a letter of formal notice was issued by the Commission 
on 7 July  1997, after  a FVO mission on October  1996, for the  following 
reasons: 

Carcasses of dead ruminants used as food  for certain wild animals contrary to 
Directive 90/667/EEC  and Decision 96/449/EC. 

Inadequate enforcement  of feed ban under Decision 94/3 81/EC as inadequate 
controls imposed to detect mammalian protein in ruminant feed  (notably no 
microscopic  tests). A Finnish reply to this allegation is being currently 
examined by the Commission  services. 

9. 

Italy 

Based on the results of a visit by Commission veterinary inspectors between 
25 and 29 November  1996 and subsequent discussion of the results, the 
Commission began infringement  proceedings on 26 June  1996 with regard to 
the application  of Decision 94/381/EC, and in particular to the  insufficient 
number of specific  controls concerning the accidental or fraudulent inclusion 
of mammalian meat- or bonemeal in ruminant  feed. 

The Italian reply to the letter of formal  notice sent on 7 July  1997 provided 
indications as to the number of controls carried out, their type  (documentary 
and microscopic  analysis), the detection rate of suspect samples and the 
follow-up  in such cases (760 controls carried out between May  1996 and May 
1997,  155 of them microscopic; eight own-initiative cases) (see footnote  (1)). 

10.  Portugal 

A letter of formal  notice, based on the decision of 26 June  1997 by the 
Commission to open an infringement  procedure, was issued by the 
Commission  on  10 July  1997 for the following  failure  to co-operate with 
Commission  in answering its written requests for information,  which is a 
breach of Article 5 of the EC Treaty. 

22 

In addition to the breach of its obligations mentioned above, the veterinary 
inspection mission to Portugal which took place between  15-21 June  1997 
recorded infringements  of Directive 90/667/EEC and Decision 96/449/EC and 
a complementary  letter of formal notice was sent on 3 December  1997. No 
reply has been received. Therefore  the Commission decided to dispatch a 
Reasoned  Opinion on 7 April 1998. 

11.  Denmark 

A veterinary inspection mission in July  1997 showed that two plants were not 
operating in full  conformity  with the requirements of Decision 96/449/CE  and 
some mammalian meat and bone meal which had not been processed as 
required had been sold in Denmark or exported to third countries. 
Furthermore the control of mammalian meat and bone meal during the 
transport from one plant to another in order to complete the process laid down 
in the decision, appeared  not to be sufficient.  Therefore  the  Commission 
decided on 25 March  1998 to open an infringement  proceeding. 

12.  Greece 

In the light of the finding by the FVO, during the inspection visit carried out 
between 29 September and 3 October  1997, of significant  shortcomings in the 
implementation  of Decisions 94/381/EC and  96/449/EC, the Greek 
authorities have provided information  on specific measures adopted in order 
to comply strictly with the requirements of Decision 96/449/EC. However, 
there have been no indications concerning the implementation of Decision 
94/381/EC. The Commission therefore  decided on 25 March  1998 to send a 
letter of formal  notice demanding that samples be taken and analysed with a 
view to establishing that proteins derived from mammalian tissues are not 
being used in ruminant  feed. 

c) 

Position in relation to Member States - handling illegal UK exports 

In relation to the illegal beef exports the Commission is also continuing its 
examination on whether those Member States where the illegal beef was 
handled  after  it left the United Kingdom also failed  to control adequately the 
respect of Community  legislation. In this connection correspondence has been 
exchanged with the Belgian and German authorities. The FVO inspection 
carried out between 8-12  September  1997 brought to light failures  in the 
keeping of records to allow the monitoring of the entry and exit of meat into 
and out of packing plants and cold storage depots, resulting from 
shortcomings  in German regulations. As the reply from  the German 
authorities was considered unsatisfactory,  the Commission decided to begin 
infringement  proceedings. In the case of Belgium, new Royal Decrees and 
circulars have stepped up the system of checks on premises. 

d) 

Other cases 

In relation to France the prohibition  of use of fishmeal in animal feed  and 
requirements on import of petfood from certain 3rd countries (notably the 
USA and Canada) are currently being  examined. 

23 

Italian restrictions on fish meal similar to those of France are also being 
examined. 

e) 

Conclusions 

In conclusion, the commencement of infringement  proceedings  following 
FVO inspection visits in the Member States has brought about  considerable 
progress in the bringing into line of the national regulations of the Member 
States concerned, and in actual compliance with the Community  regulations 
under examination. Where shortcomings persist, the Commission will 
continue with the proceedings already begun. Similarly, the Commission will 
commence new proceedings as and when new inspections establish the 
existence of new infringements.  In other situations, where  reinforcing 
Community regulations appears to be a more legally certain approach, the 
Commission will make the appropriate legislative proposals. This is 
particularly the case with the level of checks required in Member States in 
connection with the application of Decisions 94/381/EC and 96/449/EC. 

With regard to the recommendation made to the Commission to carry out 
follow-up  inspections on principle, prior to any infringement  proceedings, to 
verify  whether shortcomings uncovered and pointed out during previous 
inspections have actually been rectified,  the Commission points out that the 
principle of on-the-spot verification  of the fulfilling  of commitments made 
following  the veterinary inspection has already been applied on several 
occasions in the infringement  dossiers. In the context of the BSE dossiers, the 
Commission has systematically  set out in a pre-infringement  letter the 
deficiencies  noted during inspection visits and, on the basis of comments by 
the Member States, commenced infringement  proceedings where those 
infringements  apparently persisted. Follow-up visits are very useful  in 
highlighting the persistence of infringement  situations, especially where 
practices are concerned, and for moving on to the following  stages of the 
infringement  proceedings (reasoned opinion or reference  to the courts). 

However, it would not be normal practice to delay the initiation of 
infringement  proceedings until follow-up  missions have been undertaken, as 
this might lead to further  delay in any necessary action being taken. 

3.3.  New information  obtained by the FVO inspectors with regard to 

implementation  of Decision  96/449/EC 

As indicated in the Special Report to the European Parliament of January  1998 
all intended missions concerning implementation  of Decision 96/449/EC  were 
carried out.  All draft  reports were submitted to the Member States and the 
Commission services responsible for infringement  procedures.  The results 
were summarised in the Special Report to the European Parliament.  A 
document describing the general conclusions of the inspectors on the basis of 
the results was finalised  and was discussed with Member States in April  1998. 
This document is annexed to the present report (see annex 2A).  Follow-up 
missions are currently being undertaken. 

24 

In order to follow up points raised by the inspection service and to reconsider 
legislation, taking into account the latest scientific  advice, a working 
programme has been established (cf. annex 2B). 

As part of this working programme an amendment of Decision 96/449 EC is in 
preparation in order to: 

•  Clarify  problems of legal interpretation raised in the framework of the 

infringement  procedures and during the Community inspection missions in 
Member States, and in particular the  following: 

-  definition  in article  1  (high-low risk, catering waste etc.) 
-  derogations laid down in article  1(2) ('bones fit for human  consumption', 

fertilisers  etc.); 

• 

• 

introduce health requirements for the production of tallow and MBM in line 
with the new advice of 26-27 March  1998 of the Scientific  Steering 
Committee; 

take into account some technical remarks made by the FVO in its document 
describing the  general conclusions (see: 1st paragraph of point  3.3.) 
validation of rendering plants, post-sterilisation treatment,  etc.). 

Furthermore, the Scientific  Veterinary Committee will be asked to reconsider 
its document on the validation procedure for rendering plants, in view of the 
standards imposed by Decision 96/449/EC. 

4. 

SITUATION  WITH REGARD  TO THE UK BEEF BAN 

4.1. 

Submission  to the European Parliament of the report of the mission  to the 
UK 9-13.6.97 

The report of the FVO mission to the UK from  9 to  13 June  1997 with regard 
to the pre-conditions of the Florence Agreement  (Doc. XXIV/1525a/97-EN) 
was submitted to the European Parliament in October  1997. 

4.2.  Appropriate  action on the basis of scientific  advice on the UK's  Export 

Certified  Herd Scheme (ECHS) 

In the Council Decision on emergency measures to protect against BSE, 
repealing Commission Decision 96/239/EC and amending  Commission 
Decision 94/474/EC, it was decided to lift  the ban on exports from Northern 
Ireland  for herds authorised  for export. 

This first step to lift  the UK beef export ban could be taken because a 
computerised  traceability system for bovines is in place in Northern Ireland. 
Strict controls on the eligibility of the animals to be slaughtered under the 
scheme and on the separation and traceability of the products have been laid 
down following  a mission undertaken by the FVO in November  1997 to assess 

25 

the proposed procedures and controls concerning the Export Certified  Herd 
Scheme (ËCHS). 

As foreseen  by the Council Decision (see Article 6(5)) a further  mission has 
been carried out to inspect the implementation of the ECHS. Following this 
mission, Northern Irish authorities have taken all necessary action to 
implement the ECHS rules as laid down in Council Decision 98/256/EC. The 
implementation phase is well managed and national legislation including the 
rules of the ECHS is planned to come into effect  in the beginning of  May ft 
1998. Only one slaughterhouse and one cutting plant asked for approval and 
are foreseen  to receive it. The mission report will be presented to the  Standing 
Veterinary  Committee in due time in order to inform  the Member States on the 
outcome of the mission. Subsequently the Commission shall set the date on 
which dispatch may commence. 

4.3. 

The UK proposal on a Date-Based Export Scheme (DBES) 

The UK draft  relates to the export of meat and meat products from bovine 
animals aged between six and 30 months born after  1  August  1996, to a cow 
which was still alive six months after the animal's birth, or imported  after  that 
date and raised in the UK. 

The UK's proposal of a date-based export scheme was submitted to the SSC 
on 2 Octobre  1997 and it issued opinions on the proposal at its meetings of 
8/9 December  1997 and 22/23 January  1998. On 27 January  1998, a revised 
version of the proposal was received on which the SSC commented  at its 
meeting of  19/20 February  1998. The SSC is largely in agreement with the 
proposal, insofar  as it would ensure a sufficient  degree of safety  of de-boned 
meat. 

The Commission  services have held a number of meetings with the UK 
authorities to discuss the possibilities for a date-based export scheme, in the 
light of the opinions of the SSC. 

The Commission  intends to put forward  the appropriate legislative proposal 
shortly. 

4.4. 

Introduction  of a legal requirement for traceability  of gelatine and certain 
other products made in the UK from non-UK material / Reinforcement  of 
veterinary checks with regard to Decision  96/239/EC 

The Council, meeting on  16 and  17 March  1998, adopted Decision  98/256/EC 
on emergency measures to protect against BSE, repealing  Commission 
Decision 96/239/EC  and amending Commission Decision 94/474/EC. 

It is worthwhile recalling that Commission Decision 96/239/EC of 
27 March  1996 imposed an absolute ban on the export of live bovine animals, 
their meat and meat products, tallow and gelatine, and mammalian  derived 
meat- and bonemeal from the United Kingdom.  Commission 
Decision 96/362/EC of  11 June  1996 permitted the resumption under certain 
conditions of exports from the United Kingdom of meat, meat products, meat 

26 

preparations  for human consumption, food  for domestic carnivores  obtained 
from  bovine animals which were not slaughtered in the United Kingdom  and 
products obtained  from  bovine animals slaughtered outside or within the 
United Kingdom. 

The new Decision of  17 March  1998 restricts to technical purposes the export 
of gelatine, di-calcium phosphate, collagen, tallow, tallow products and 
products derived from tallow produced in the United Kingdom from animals 
slaughtered  in the United Kingdom, thus excluding their use in the human and 
animal food  chain or in the manufacture  of cosmetic, medical or 
pharmaceutical  products. 

In addition, the Council Decision on emergency measures to protect  against 
BSE, repealing Commission Decision 96/239/EEC and amending  Commission 
Decision 94/474/EEC  introduces a legal obligation for the traceability of 
gelatine and other products manufactured  in the United Kingdom from 
material not originating in the United Kingdom and eligible for  export, 
strengthening  in particular the conditions governing labelling, marking and 
certification.  Furthermore, processing of these products must be carried out in 
a different  place or at a different  time from non-eligible products. 

Finally, it steps up the controls to be carried out by official  veterinarians in 
authorised  establishments. FVO inspections are also intended to  verify 
application of the provisions and implementation  of official  controls. 

These control elements were elaborated by an inter-service expert group and 
had been described in the FinaJ consolidated  Report on the follow-up  of 
recommendations  on BSE (COM(97) 509 final). 

Furthermore following  new control provisions, which have been included in 
the Council Decision, transit of beef through the United Kingdom has now to 
take place in sealed trucks and to be covered by veterinary  certification. 

5. 

LEGISLATION 

5.1.  Co-decision  procedure 

The Commission would, first of all, recall that it has defined  and  implemented 
a policy, whereby it has proposed the use of a legal base, which implies the 
appropriate involvement  of Parliament: this policy will continue in line with 
the Commission's  undertaking thereon to Parliament. Indeed, as the 
Parliament rightly points out, the Commission has introduced proceedings in 
the Court of Justice against the Council, because that institution did not accept 
the legal base proposed by the Commission. 

The Commission also notes with satisfaction  Parliament's support for  its 
commitment  to the creation of an adequate legal base which would meet 
present and future  needs on public health at Community level. The new 
provisions of the Amsterdam Treaty regarding public health serve to broaden 
the scope and effectiveness  of the Community's competence in the domain. In 
particular, the new Article  152 effectively  makes the link between  veterinary 

27 

and phytosanitary measures and public health and it makes that link within the 
context of the co-decision procedure. This last innovation will, of course, 
ensure the full  participation of Parliament in any future  measures in the field. 

The Commission is strongly of the view that the new Article  152 creates a 
more precise legislative apparatus which would ensure a situation, such as the 
BSE crisis, be effectively  covered at Community level. 

In the current context, it is worthwhile highlighting the following  dossiers: 

Proposal  for a Council Regulation on measures to promote and market 
quality beef and veal and on information  measures concerning the  labelling 
of beef and veal, repealing Regulation  (EEC) No 2067/92. 

The Commission has amended the initial legal basis (Article 43 only) and 
accepted the European Parliament's  amendment concerning the inclusion of 
Article  129 as the legal basis for consumer information  measures. This 
amendment has not been accepted by the Council, but it has been unable to 
obtain unanimity in order to amend it. As a result, the former  Regulation 
remains in force; 

Council Regulation  (EC) No 820/97 of 21 April  1997 establishing  a system 
for the identification  and registration of bovine animals and regarding the 
labelling of beef and beef products. 

The Council adopted its decision unanimously, contrary to the opinions of 
the Commission  and the Parliament. The Commission is currently  contesting 
this decision before  the European Court of Justice (Case C296/97 of 22 July 
1997). The Court's judgement will not be announced until  1999; 

Preparation of a TSE regulation based on Article  100a. 

As soon as possible, the Commission will submit to the Council  and the 
European Parliament  a proposal for a global, long-term system for the 
surveillance of transmissible spongiform  encephalopathies  on the basis of 
Article  100a. 

5.2.  General  legislative  measures 

i) 

Assessment  of further  changes to Directive  85/374/EEC 

By  adopting  proposal  for  a  Directive  COM(97)  478  of  1 October  1997,  the 
Commission  followed  the  EP's  recommendation  in  1997  to  extend  Directive 
85/374/EEC  to  primary  agricultural  products.  The  current  proposal  should 
meet the European Parliament's concerns in the context of BSE. 

However,  the  Commission  must  report  every  five  years  on  the  application  of 
the  1985 Directive  (Article 21 of Directive  85/374/EEC). In the context  of this 
periodical  monitoring,  the  Commission  may  present  further  proposals  to 
modify  the Directive. 

28 

Once the current proposal  is adopted by the European Parliament  and  Council, 
consultation  will  take place  to assess whether  any  other  initiative  is needed  in 
a context broader than the follow-up  of the BSE enquiry. 

In its Opinion of 29 January  1998, the ECOSOC supports this approach. 

ii) 

Food policy and the general principles  of Food Law 

The Commission published  in May  1997 a Green Paper on the General 
Principles of Food Law in the European Union. In response to this 
consultation document, the Commission has received some  150 comments, 
which are at present being analysed by the responsible services. The 
Commission intends to give its reply to these comments in the form  of a 
communication to the Council  and the European Parliament to be published 
before  the summer this year. This communication will outline the principles 
on which the Commission will base its future  actions as regards  food 
legislation  and wherever possible, a timetable for legislative proposals. 

Furthermore the Commission has organised together with the European 
Parliament in November  1997 a Conference  on Food Policy and Food Law 
and published  a conference report in December. The information  gathered 
during this conference  will also be taken into account in the preparation  of the 
above-mentioned  communication. 

iii) 

Completion  of simplification  exercise on food hygiene legislation, 
including veterinary  and phytosanitary  legislation 

The Commission is currently involved in simplifying  the legislation on 
veterinary hygiene (13 Directives on food hygiene and three on animal health) 
and the Directive on the hygiene of foodstuffs  (Directive 93/43/EC). This 
work should be completed by the end of  1998. The new legislation will be 
based on a general application of the Hazard Analysis and Critical  Control 
Points (HACCP) principles, extended to cover the entire production  chain. 

iv) 

Entry into force of regulation  EC/820/97  (beef  labelling) 

The Commission's  implementing regulations relating to Council  Regulation 
(EC) No 820/97 establishing a system for the identification  and registration  of 
bovine animals and regarding the labelling of beef and beef products  have 
been  adopted. 

With regard to identification  and registration,  they relate to: 

transitional provisions for the start-up period of the system for the 
identification  and registration of bovine  animals 
(Regulation  (EC) No 2628/97); 

eartags, holding registers and passports (Regulation (EC) 2629/97); 

29 

the minimum level of controls to be carried out 
(Regulation (EC) No 2630/97); 

the application of minimum administrative  sanctions 
(Regulation (EC) No 494/98). 

With regard to labelling, they relate to: 

mutual recognition (Regulation (EC) No  1141/97, Article 1); 

minimum requirements  for the  specification 
(Regulation  (EC) No  1141/97, Article 2); 

- 

checks (Regulation (EC) No  1141/97, Article 3); 

sanctions (Regulation (EC) No  1141/97, Article 4). 

approvals granted by third countries (Regulations (EC) Nos 2406/97 and 
824/98 amending Regulation (EC) No  1141/97). 

In addition, the Commission will submit to the European Parliament  and the 
Council during the first half of the year a draft  Directive based on Article  100a 
and amending Directive 64/432/EEC on animal health problems  affecting 
intra-Community trade in bovine animals and swine, to enable the 
Commission, if necessary, to adopt implementing procedures relating to 
databases in order both to ensure exchanges of data between the  different 
national bases and to guarantee their operational nature. 

The Commission also launched the IDEA pilot project  at the beginning of 
1998 on the electronic identification  of bovine animals. 

Finally, a report in accordance with Article  10 of Council Directive 
92/102/EEC on the identification  and registration of animals has been drawn 
up and will be presented to the Council. 

In its proposal for a Council Regulation on measures to promote, and market 
quality beef and veal and on information  measures concerning the labelling of 
beef and veal repealing Regulation  (EEC) No 2067/92, the  Commission 
included  a measure intended to inform  consumers of the guarantees offered  by 
the labelling system. Provision has been made for funding  this measure. 

However, the Council has not adopted this proposal. 

5.3.  Reinforcement  of  controls in the European  Union 

•  Harmonisation  of  control  plans 

In May  1998, the Commission is to submit to the Standing  Veterinary 
Committee a draft  Commission Decision laying down the procedures 
concerning essential information  relating to the veterinary checks carried out 
under the terms of Directive 89/662/EEC. The draft  provides  for the 

30 

computerised  forwarding  to the Commission, in accordance with a harmonised 
model, of essential information  relating to checks carried out at the point of 
origin and on arrival at destination. In particular, this information  relates to the 
number of establishments subject to checks, the quantities checked, the checks 
carried out, the results of those checks and the staff deployed to carry them 
out. 
In accordance with Article  16 of Directive 89/662/CEE, the information  will 
be examined by the Commission within the framework of the Standing 
Veterinary  Committee. 

Reinforcing  sanctions 

With regard to Regulation EC/820/97 (beef labelling) rules on the  application 
of minimal  levels of administrative sanctions have been laid down by 
Regulation EC/494/98 (see point 5.2. iv). 

Reinforcing  routine controls 

in meat production plants 

Following inspections carried out in the Member States, which highlighted 
fraudulent  practices in contravention of Community regulations  governing 
BSE, the Commission is to submit to the Council a draft  Council  Directive 
amending Directive 64/433/EEC on health problems affecting  intra-
Community trade in fresh meat with a view to stepping up health measures. It 
is planned  to step up official  checks on the production process, health marking 
and certification  procedures, and to introduce a requirement  for meat 
production plants to keep records of their animal feed  production. 

in animal  feed 

Article 22 of Directive 95/53/CE fixing the principles governing the 
organisation  of official  inspections in the field of animal nutrition obliges the 
Member States to draw up, by  1 October  1998 at the latest, programmes 
setting out the number and frequency of inspections, which must be  performed 
regularly. In the light of the shortcomings noted in the Member States, the 
Commission is currently assessing the regulations with a view to stepping up 
the effectiveness  of the checks carried out by Member States to ensure 
compliance with Decision 94/3 81/CE prohibiting the use of mammalian 
derived protein in ruminant  feed. 

Thus, with regard to the sampling method, a draft  amendment to Directive 
76/371/CEE is being studied.  In addition, the Commission will take into 
account the results of the study of microscopic methods of analysing the 
composition  of animal feed,  and will submit a draft  amendment to Directive 
70/373/CEE  (see also item 1.3.ii). 

Finally, the Commission intends to amend Article 22 of Directive 95/53/CE in 
order to give itself the possibility of drawing up specific  programmes of 
checks at Union level, laying down in particular their frequency, alongside the 
general national programmes provided  for in that Article. 

31 

The SSC recommends to avoid cross-contamination between raw material 
from  different  animal species and between the final products to be consumed 
by different  species. The Commission will propose the necessary EC 
legislation  to include measures to avoid contamination of ruminant  feed  with 
mammalian protein during production and transport. Furthermore, the 
Commission will propose the necessary EC legislation  to lay down details 
concerning controls based, if possible, on a uniform  analytical method, as soon 
as such a method will be available and validated. 

5.4. 

Surveillance and control of communicable diseases and other health 
issues 

i) 

Establishment  of a Community network for the surveillance  and control 
of communicable  diseases  and of an action programme on rare diseases 

The surveillance  and control of communicable diseases is one of the  major 
strands of action in the field of public health. The strategy that the 
Commission has developed in this area encompasses the following  closely -
co-ordinated  activities: 

• 

Setting up and building on co-operative networks on specific  diseases 
involving the surveillance authorities and competent institutes of the 
Member States; initiating and developing the most important  field 
epidemiologist training action outside the US, the production  and 
dissemination to the surveillance and control constituencies  of monthly 
survey publications and a weekly electronic bulletin, and the 
establishment  of methods and protocols for collecting and  sharing 
surveillance data; and facilitating regular contacts and co-operative  efforts 
of the surveillance institutes of the Member States, all in the context of 
the 5-year (1996-2000) Community programme of action on AIDS and 
certain other communicable diseases. 

•  Creating, as part of the Community's IDA programme, the  appropriate 
technical infrastructure  for the timely and accurate exchange of data 
between the administrations in charge of the surveillance, prevention,  and 
control of communicable diseases in order to enable them to take the 
requisite measures as soon as outbreaks occur. 

•  Undertaking a major co-operative effort  with the US in the context of the 
New Transatlantic Agreement (NTA), and in collaboration with the 
WHO, to set up a global effective  early warning system and response 
network  for communicable diseases. 

•  Convening  expert groups on specific  topics of communicable  disease 
surveillance and control (such as Ebola, avian influenza, blood  safety, 
etc.) and providing for the regular mutual consultation and rendering of 
regulatory advice among key national experts from the Member States. 

•  Collecting and collating epidemiological data on CJD from focal  points 
designated by the Member States, on the basis of protocols developed in 

32 

the context of the 4th Community R&TD Programme  and forwarding  this 
information  to the Council and the European Parliament,  at  6-month 
intervals, following  the express request of the former  to assist Health 
Ministers in their deliberations concerning that disease and its 
implications for public health action. 

Launching  a major  initiative to equip the Community with an instrument 
to counter the emergence or spread of communicable  diseases, by tabling 
a proposal  for a decision by the European Parliament  and the Council, 
pursuant to Article  129, to set up a Community network  for the 
surveillance and control of communicable diseases with express 
obligations on the Member States for detecting and responding to 
communicable  disease outbreaks. 

The proposal was presented on 8 March  1996, before  the  announcement 
of a possible link between BSE and CJD, and envisaged the compulsory 
notification,  alert, and other public health measures on a number of 
diseases, including  CJD. It aims at securing a broad enabling measure (the 
decision by the European Parliament  and the Council), within which a 
series of further  decisions by the Commission or the Council could be 
promulgated  on specific  topics. The areas covered were: 

• 

• 

• 

• 

the creation of a network for the sharing of validated  information 
derived  from  the surveillance of selected diseases including CJD: 

*& 

the establishment  of requirements for the epidemiological  and 
microbiological  surveillance methods used, including case  definitions 
and the format  of data to be  transmitted; 

the use of the network  for rapid alert in the case of 
outbreaks/emergencies  occurring both within and outside the 
Community relating to  specific  diseases; 

the use of the network to provide information  to the Member States on 
control measures applied  and the results of special investigations  into 
outbreaks; 

•  provision  for the consultation  and co-ordination  of the Member  States 

concerning protective measures; 

•  provision  for Community protective measures. 

The EP gave a favourable  opinion on the proposal on  13 November  1996, as 
did ECOSOC  on 25 September  1996 and the CoR on  13 June  1996. The 
Commission  tabled  an amended proposal, accepting most of the EP's 
amendments, on 5 February  1997. 

The Council  adopted  on 22 July  1997 a common position on this proposal 
The Commission  reserved its position on the Council's common position, as, 
in its view, the text agreed by the Council represented  a considerable  watering 
down of its initial proposals, especially with regard to the possibility  of taking 
measures at the level of the Community. It pointed out that the goal of the 

system proposed was the introduction of appropriate counter-measures  both at 
the national  and Community level, and thus exclusion  or circumscription  of 
the latter would deprive the system of much of its value. 

On  14 January  1998 the European Parliament  adopted 22 amendments to the 
common position. The Commission accepted wholly or partially  17 of these 
amendments and forwarded  to the Council an amended proposal on 
13 February  1998. The Council noted that it could not accept all of the 
Parliament's  amendments, and preparatory work is now in hand with a view to 
the launching of the conciliation procedure once trilogue deliberations  have 
reached the appropriate point. 

•  A further  important  step in respect of action on CJD was taken on 26 May 
1997 when the Commission presented  a communication  and a proposal 
for a European Parliament  and Council decision adopting a 5-year 
Community public health action programme on rare diseases pursuant to 
Article  129 of the EC Treaty (OJ C203, 3 July  1997, p.6). One of the 
objectives  of the programme is to promote actions in favour  of patient  and 
family  support  groups who have been directly or indirectly affected  by 
rare diseases, including neurodegenerative  conditions. 

The actions envisaged  in pursuit of this objective  include: 

• 

• 

promoting the establishment  of groups of those persons with the same 
rare conditions or those professionally  involved in order to  disseminate 
their experience, to facilitate  training and to co-ordinate their activities at 
national  and Community  level; 

promoting collaboration  and networking between support groups and the 
setting-up of umbrella bodies, focusing particularly on efforts  to 
encourage the continuity of work and cross-national  co-operation. 

The programme  explicitly recognises that patient  support groups  (including 
sufferers  and their families)  can play a key role in relation to rare diseases as 
there is often  a lack of information  and health care facilities  relating to such 
diseases.  Patient  support groups have a  wealth of knowledge and  experience 
in dealing with rare diseases. 

*£> 

Following the adoption of a favourable  opinion by the European Parliament at 
its March  1998 session, the Commission has forwarded  an amended proposal 
to Council, with a view to the adoption of a common position by the latter at 
its meeting on 30 April 1998. 

ii) 

Reinforcement  of the protection  of the health and safety  of workers  from 
risks related to exposure to BSE and TSE agents at work by the  adoption 
of Directive 97/65/EC 

In application  of Council Directive 90/679/EEC  as amended by Council 
Directive 93/88/EEC, employers are obliged to carry out a risk assessment  for 
all activities in which workers may be exposed, either inadvertently  or 

34 

intentionally, to biological  agents at the workplace, and to apply any necessary 
protective measures which result. 

On November  1997 the Commission adopted Directive 97/65/EC to be 
transposed  into national law by Member States by 30 June  1998, strengthening 
the existing provisions under Directive 90/679/EEC  on the protection of 
workers  from risks related to exposure to biological  agents at work, to cover 
situations arising from  exposure to agents responsible  for BSE and other 
related TSEs, and thus reinforcing  the protection of workers,  including 
farmers,  abattoir workers, veterinarians, doctors, zoo-keepers and laboratory 
workers. 

Commission  Directive 97/65/EC makes technical amendments to the 
provisions of Directive 90/679/EEC by replacing in particular the existing 
recommendation by an obligation for the application of containment  level 
3(**) measures to be applied for all workers exposed to the agents  responsible 
for BSE and other related animal TSEs which will now be classified  in the 
same hazard group as the agent responsible for CJD, including the new variant 
CJD, under the Community classification  of biological  agents. 

iii) 

Proposal  on effective  surveillance of TSEs in animals in the Member 
States 

After  receiving the opinion of the Standing Veterinary  Committee, meeting on 
3-4 March  1998, the Commission adopted a Decision  concerning 
epidemiological  TSE surveillance and amending Decision  94/474/EC, 
enablin'g a harmonised  approach in the Member States and imposing  a duty to 
notify  detected cases of TSE to the Commission  and to the other Member 
States (Decision 98/272/CE, OJ L 122, 24 April  1998). 

As soon as possible, the Commission will submit to the Council and the 
European Parliament  a proposal for a global, long-term system  for the 
surveillance of transmissible  spongiform  encephalopathies on the basis of 
Article  100a. 

5.5. 

Exclusion  of risk material from the food  and feed chain 

i) 

Commission  consultation  paper on exclusion  of high risk material  from 
the feed  chain  and on a ban on feeding  animal protein  to ruminants 

The Commission  consultation paper was published on the Internet from 
14 November  1997. 

In addition the Consultation Paper was directly addressed to a number of 
professional  associations, organisations, federations  and other bodies, and was 
presented  to the following  Committees: the Standing Veterinary  Committee, 
the Standing Committee of Animal Nutrition, the Waste Management 
Committee and the Veterinary Advisory  Committee. 

35 

Until the end of February  1998, the Commission received  75 comments on this 
consultation,  from  a wide variety of organisations, including  farmers, 
Tenderers, feed  manufactures,  meat producers, consumers and  professional 
organisations, as well as from  governments of Member States and Third 
countries, and individual citizens. 

All of these comments were accepted by the Commission  and are currently 
being collated and assessed. The relevant document  titled "Summary of the 
Comments Received  on the Consultation Paper on Meat and Bone Meal" is 
available. 

This should  lead to an amendment to Council Directive 90/667/EEC  laying 
down the veterinary rules for the disposal and processing of animal waste,  for 
its placing on the market and for the prevention of pathogens in feedstuffs  of 
animal or fish origin and amending Directive 90/425/EEC. 

ii) 

Adoption  of a feed ban on MBM not produced  in accordance with the 
standards  of Decision  96/449/EC and restriction  on use 

On 21 October  1997, the Commission adopted Decision  97/735/EC 
concerning certain protection measures with regard to trade in certain types of 
mammalian  animal waste. 

Following article  1 (2) of this Decision Member States shall ensure that 
mammalian  animal waste falling within the scope of Decision  96/449/EC 
which has not been processed in accordance with the parameters laid down in 
that Decision cannot enter the feed  chain. 

This Decision restricts trade in wastes processed in accordance with the 
parameters laid down in Decision 96/449/EC1 to well-defined  purposes such as 
incineration  or use as fuel. The Member State of destination must have been 
informed  by the Member State of origin and must have authorised the receipt 
of the material. The material must be accompanied by an official  certificate 
clearly indicating  its use and the fact that it is not for animal  consumption. 

iii) 

S RM: Proposal to exclude specific  hazardous  materials from the human 
or animal  food  chain 

Noting the existence of a simple majority  in the Council  against the new 
Commission proposal  on the prohibition of the use of material presenting  risks 
as regards transmissible  spongiform  encephalopathies  and repealing 
Decision  97/534/EC of 30 July  1997, the Commission proposed  repealing 
Decision 97/534/EC. The Council, in contrast, decided unanimously  at its 
meeting on 31 March  1998 to postpone once again, to  1  January  1999, the date 
of entry into force of the Decision of July  1997 (Council Decision  98/248/EC). 

In the light of this decision, the Commission  issued  a statement  saying that it 
was astonished  at this attitude, even though, throughout  recent months, the 
Council  had hampered  all efforts  by the Commission  towards the adoption of a 

36 

Decision amended in the light of the latest scientific  data and aimed at 
ensuring a Community level of health protection  for consumers. 
Decision 97/534/EC is based on the safeguard  clauses of the Directives on 
veterinary checks on live animals and animal products deriving from  Article 9 
of Council Directive  89/662/EEC concerning veterinary checks in 
intra-Community trade with a view to the completion of the internal market 
and Article  10 of Directive 90/425/EEC 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. 

With regard to the proposal for a global, long-term system of surveillance  for 
transmissible  spongiform  encephalopathies based on Article  100a, the reader is 
referred  to item 5.3.hi above. 

iv) 

Labelling of compound  feedingstuffs 

Any proposal relating to the quantitative and qualitative labelling of animal 
feed  should permit reliable monitoring of the data and be based on recognised 
analytical methods. Additional studies of analysis methods are under way (see 
item  1.3.ii). 

v) 

Destruction  of MBM /  Landfill 

•  Destruction of MBM 

The  stockpile  of  MBM  resulting  from  the  Over  Thirty  Months  Scheme 
(OTMS)  stands  at present  (20 March  1998)  at  313.000 tonnes.  Concerns  have 
been  expressed  that  this  stockpile  should  be  completely  destroyed  as  quickly 
as possible. The Commission has asked the United Kingdom  to provide  a plan 
and  a timetable  for  disposing  of  animal  meal.  In  a  letter  dated  2  April  1998, 
the  UK  Government  said  it  is  pressing  forward  with  negotiations  to  increase 
disposals  by' incineration.  First  contracts  are  expected  to  be  concluded  in 
April/May  1998.Provided  that  any environmental  or planning  consents  can be 
obtained  quickly,  the  scale  of burning  will  increase  substantially  in  the  latter 
part  of  1998. If timescale  can be met,  the backlog  of  stored  product  would  be 
burned over the next 2-3 years. 

• 

Landfill 

Question had been raised about whether material had been landfilled.  During 
1996 the UK authorities took national measures, notified  as State aids to the 
Commission  and approved as such in May and June  1996, to provide 
assistance to slaughterhouses to remove an estimated 40.000 tons of unsalable 
beef and beef products on the UK market (Beef  Stock Transfer  Scheme) and a 
service for the disposal of unsold beef products resulting from the legal 
measures taken on BSE at Community and UK level (Beef and Beef products 
Disposal  Scheme. According to Commission's  information  material from 
these schemes has been landfilled.  However the Commission has received no 
information  nor found  any evidence of landfill  of MBM  from  EAGGF-funded 
37 

schemes (Over Thirty Month Scheme, Selective Cull Scheme, Pre-1996 
intervention beef-Reg. 1757/96) having taken place. 

A set of studies  have been carried out to assess the risks from various  aspects 
of disposal of material  arising from  the BSE situation, including BSE 
carcasses in landfills. These studies were prepared by a private consultant  on 
behalf of the Environmental  Agency of the UK. In November  1997, a national 
scientific  evaluation  of these studies was asked. So far,  scientific  evaluation 
has not  started. 

6. 

INTERNA  TIONAL  ASPECTS 

6.1. 

Participation, collaboration  and membership of the Commission  in 
international  organisations 

Within the framework  of the World Trade Organisation, and in carrying out 
the re-examination  for the SPS (Sanitary and Phytosanitary  Measures) 
Agreement, the Commission is currently assessing whether to propose 
extending the agreement to include aspects relating to consumer concerns, 
particularly the well-being of animals. 

The Commission, as observer, has continued to participate actively in the 
meetings of both the World Health Assembly and the Executive Board of 
WHO. It has been invited and took an active part in the various expert 
meetings convened by WHO on the topic of both BSE and CJD. 

With regard to the IOE, the Commission is to transmit to the Council  and the 
European Parliament a draft  Decision formalising  the co-ordination  procedure 
between the Member States and the Commission in preparation for the 
European Community's  accession as a full  member. The main problem in this 
respect is the fact  that the non-member countries are not prepared to accept the 
Commission  as a full  member and speaking on behalf of the Community 
unless the votes of the  15 Member States are replaced by a single vote for the 
Community. In addition, the Commission's  admission is dependent upon an 
amendment  to the IOE statutes. 

As an observer, the Commission plays an active part in the various  committees 
of the Codex Alimentarius. The current  situation should be rectified  as soon as 
possible by allowing the Community full  member status. A proposal to this 
effect  has been presented to the Council, which has given the Commission a 
mandate, and negotiations with the Codex Secretariat have begun. The 
Commission  intends to speed up the dossier. It is shortly to present  a proposal 
to the Member States, and hopes that the Community will be a member of the 
Codex with effect  from  1999. 

6.2.  MBM safety  standards + general standards in the OIE 

With respect to the harmonisation  of international  standards for the production 
of meat-and-bone meal the next General  Session of the World Organisation  for 

38 

Animal Health (OIE -  Paris) at the end of May is of importance. The present 
OIE Code on inactivation of transmissible spongiform  encephalopathy  agents 
during the production of meat-and-bone meal is less restrictive then our 
present Community legislation  and not fully  in line with the recent  scientific 
opinion of the Scientific  Steering Committee. The Commission, in its 
Commission  Staff Working Paper on the position to be taken by the 
Community, proposes to take the recent opinions of the Scientific  Steering 
Committee of 26 March  1998 on gelatine, tallow and meat-and-bone meal  into 
consideration when examining the proposed chapter on bovine  spongiform 
encephalopathy. 

6.3.  Hormones, feedingstuffs  additives 

The SPS Agreement covers measures  intended: 

"

• &• 

• 

• 

• 

to  protect  animal  or  plant  life  or  health  from  risks  arising  from  the  entry, 
establishment  or  spread  of  pests,  diseases,  disease-carrying  organisms  or 
disease causing organisms; 

to protect  human  or  animal  life  or health  from  risks  arising  from  additives, 
contaminants,  toxins  or  disease-causing  organisms  in  foods,  beverages  or 
feedstuffs; 

to  protect  human  life  or  health  from  risks  arising  from  diseases  carried  by 
animals,  plants  or  products  thereof,  or  from  the  entry,  establishment  or 
spread of pests; 

•  and to prevent or limit other damage from  the entry, establishment  or spread 

of pests. 

The  SPS  allows Members  to require  imported  animals, plants  and  products  to 
meet their SPS standards (or equivalent provisions). 

The  hormones  case  is  likely  to  set  the  standard  for  interpretation  of  the  SPS 
Agreement in future  cases, thanks also to the very thorough analysis  conducted 
by  the  Appellate  Body  as  a  result  of  the  EC's  appeal  of  the  original  panel 
report. 

The  original  panel  report  misinterpreted  the  SPS  Agreement  and  gave  a  very 
unbalanced  view  of  WTO  Members'  obligations  under  the  SPS  Agreement. 
Some  interpretations  were  seen  as  effectively  undermining  Members'  right  to 
set the level of protection they deemed appropriate, such as: 

- 

the panel's  interpretation  of international  standards as binding norms  from 
which  deviation  due to a higher  level  of protection  was  considered  not  as 
an autonomous right, but rather as an exception, 

the  panel's  finding  that  the  burden  of  proving  that  sanitary  measure  is 
compatible  with  the  SPS  Agreement  rested  on  the  country  adopting  the 
SPS  measure  rather  than  on the country  bringing  the  case  to  establish  the 
inconsistency  of the measure, 

39 

- 

an  interpretation  of  the  obligation  of  "consistency"  which  equated  the 
mere existence of different  levels of protection with a disguised  restriction 
on trade. 

The panel's interpretation of the concept of risk assessment consisted of a 
purely scientific  analysis, without the possibility of taking into account other 
factors  such as control, and without the possibility of taking into account 
minority scientific  views when adopting the SPS measure. 

The Appellate Body has corrected such erroneous interpretations. It has 
correctly shifted  the burden of proving that a measure is SPS-inconsistent  on 
the complaining country. It has furthermore  clarified  that the provisions on 
harmonisation  of sanitary measures on the basis of international  standards 
cannot be taken to mean that Members have an obligation to make their 
measures conform  to international standards. It is sufficient  that the measure is 
reasonably  supported by the risk assessment performed.  As regards 
consistency, the Appellate Body made clear that the existence of  different 
levels of protection  for different  substances or products is not enough; the 
complaining party must also demonstrate that such difference  results in a 
disguised restriction on international trade. 

The Appellate Body's most important corrections were on the concept of risk 
assessment. The Appellate Body has confirmed  the characteristics  of risk 
assessment that the EC had always thought were incorporated  in the SPS, that 
is the possibility to take into account risks arising from other factors  such as 
control, testing, conditions of use; the possibility  for responsible governments 
to take into account minority scientific  view; the absence of the requirement to 
fix a minimum  level of risk, and other factors which have a potential  for 
adverse effects  on human health in the real world. 

The Appellate body has in fact made a serious step into the direction of 
restoring the SPS Agreement to its original meaning as always interpreted by 
the EC. Distorted views of the application of the SPS Agreement  from  future 
panels now seems less probable. 

However, the Appellate Body has confirmed  that the ban on the use of six 
growth hormones in meat production is not based on a sufficiently  specific  risk 
assessment to show the existence of residues constituting  a risk to the 
consumer. The Community has undertaken to abide by the Appellate  Body's 
conclusions on this point, and to then amend Community  legislation where 
necessary in line with the results of a supplementary risk assessment. 

In this context, the Commission has started work on generating the  scientific 
data required  for a risk assessment  linked more specifically  to the residues 
from  these six hormones and their metabolites in meat. 

The Commission has freed  financial  resources for the scientific  studies 
required to produce the missing data. It has also asked the USA, Canada, New 
Zealand  and Australia to forward  the scientific  and risk assessment data they 
have used in granting legal authorisation for the use of these hormones, as set 
out in the SPS  agreement. 

40 

The Scientific  Steering Committee has appointed the Scientific  Committee on 
Veterinary Measures relating to Public Health to study the new data to be 
obtained, and the risk assessment to be carried out by a group of experts, and 
to give its opinion to the Commission. 
Meanwhile, Council Directive 96/22/EC of 29 April  1996 concerning the 
prohibition on the use in stockfarming of certain substances having a hormonal 
or thyrostatic action and of beta-agonists, and repealing 
Directives  81/602/EEC, 88/146/EEC and 88/299/EEC remains in force. 

On the basis of a report from  the Scientific  Committee on Animal Nutrition, 
the Commission has adopted a Directive amending Directive  70/524/EEC, 
which bans the use of ronidazole as an additive in  feedingstuffs. 

The Committee is currently assessing certain aspects of carbadox,  olaquindox 
and dimetridazQle as additives in feedingstuffs.  This examination follows  the 
application  of a safeguard  clause by some Member  States. In addition, within 
the framework  of Directive 70/524/EEC  as amended by Directive 96/51/EC, 
antibiotic, coccidiostatic  and other medicinal additives, as well as growth 
promoting  substances, authorised prior to  1  January  1988, will be 
systematically reassessed for a final decision before  1  October 2003 as to 
whether to retain or prohibit them as additives. 

On a wider scale, the Scientific  Steering Committee has had put before  it the 
question of the increasing resistance noted to anti-microbial agents, underlined 
both by individual  scientists and international organisations such as the WHO. 
The Committee has been invited to examine this question within a 
multidisciplinary  framework  covering all areas of use of these products. 

7. 

nvCJD  VICTIMS: CURRENT SITUATION AND ASSISTANCE  TO 
nvCJD  VICTIMS ORGANISATIONS 

7.1.  Current situation  regarding  CJD and nvCJD cases in the EU 

UPDATE ON EPIDEMIOLOGICAL  DATA 

•  Questionnaire 

In  order  to  collect  and  compile  the  latest  epidemiological  data  on  transmissible 
spongiform  encepalopathies  (TSEs), an updated questionnaire was sent in January 
1998 to the specialised  centres designated by the Member  States for the  diagnosis 
of CJD.  Additional  questions related  to the risk management  of blood  and  blood 
products in relation to human TSEs were  introduced. 

•  Notification  requirements 

With  Sweden's  decision  in  April  1998  to  make  CJD  a  notifiable  disease,  the 
number  of  Member  States  having  such  a  requirement  rose  to  9  (see  annex  3, 
table  1).  The  criteria  as  to  what  is  to  be  notified,  however,  have  not  yet  been 
standardised:  the  majority  of  Member  States  include  all  suspected  cases  of  CJD 
while  two  require  confirmed  cases  (Austria  and  Ireland).  The  situation  regarding 

41 

familial  CJD  cases  is  not  clear.  France  includes  Gerstmann-Straùssler-Scheinker 
syndrome  (GSS)  and  Fatal  Familial  Insomnia  (FFI)  in  the  criteria  of  a  notifiable 
disease,  while  Germany  explicitly  excludes  GSS.  The  criteria  for  Sweden  are  at 
present  unknown. 

Case referrals 

The  number  of  cases  referred  to  the  CJD  diagnostic  centres  for  assessment  (see 
annex 3, table  2)  increased  between  1996  and  1997  in  all  Member  States,  except 
Spain, Germany and the Netherlands. This increase included persons both  younger 
and older than 50 years. In France, the dramatic increase (nearly 350% since  1995) 
can be attributed  in part to a change in the database records, which now include all 
referred  cases  rather  than  only  those  diagnosed  as  CJD  prior  to  1996,  and  to  a 
policy  of  14.3.3  protein  and  enolase  examinations  in  patients  for  whom  CJD 
diagnosis  is very unlikely.  Another  explanation  for  this increase in many  Member 
States  is  selection  bias, as increased  awareness  among physicians  of this  problem 
results  in more referrals  of patients with neurological  disorders  for  CJD diagnosis. 
Of importance is the fact that responses from many Member  States on  consecutive 
questionnaires  show  different  referral  data,  indicating  corrections  over  previous 
years  and  the  absence  of  a uniform  way  to  define  a  'referral'.  Clarification  as  to 
what is meant by  'referral'  in each Member State is required. 

Probable  and definite cases of sporadic CJD 

The  survey  questionnaire  sought  data  on  the  probable  and  definite  cases  of 
sporadic  CJD in  1995,  1996 and  1997.  The resulting  data  (see annex  3, figure  1) 
must be interpreted with caution, since a long delay exists between the onset of the 
disease  and  diagnosis  by  a specialised  centre. Data  from  the United  Kingdom  are 
based  on  deaths,  whereas  those  of  the  other  Member  States  are  based  on  cases. 
Two  thirds  of  these  cases  were  recorded  as  'definite'  for  1995  (65%)  and  1996 
(67%)  and  only  54%  in  1997.  Important  variations  still  exist  between  Member 
States: for instance in  1997,  100% of cases were  'definite'  in Sweden  and Finland, 
90%  in UK but  only  13% in the Netherlands.  Sometimes  variations  exist  within 
one Member  State (for  example,  'definite'  cases in the Netherlands represent 73% 
and  13% of total cases in  1996 and  1997 respectively). 

Cases  ofnvCJD 

Regarding  new  variant  CJD,  the  total  number  of  definite  and  probable  cases  to 
date  is  25  in  the  United  Kingdom  and  1 in  France.  A  problem  exists,  however, 
regarding  the  date  of  notification.  For  instance,  in  France,  the  nv-CJD  case  was 
indicated  in the previous  survey as a 1996 case, according to the date of diagnosis. 
In  this  survey,  the  case  is  now  classified  as  being  from  1994  -  when  the  first 
symptoms  appeared. 

Blood products  and CJD 

With regard to the safety  of blood products, no differentiation  was made in the 
survey between the labile components used for transfusion  and the industrially 
manufactured  medicinal products derived from blood and plasma. The approach 
taken towards the safety  of blood products is summarised in table 3. With respect 
to determining donor suitability, most Member States have introduced  specific 

42 

permanent deferral  criteria that are generally the same in all Member States. WHO 
exclusion criteria are cited by two Member States (Austria, Italy) while Finland 
follows  the Council of Europe recommendations. The approach taken with regard 
to medicinal products derived from blood and plasma that may be considered to be 
contaminated  is mainly to follow the advise issued by the Committee  for 
Proprietary Medicinal Products (CPMP). Requirements in some  Member States, 
however,  appears to be stricter such as in France, where the withdrawal  of 
products covers all TSE cases; Germany, where all products except plasma are 
withdrawn for familial  or sporadic cases; and Ireland, where the policy of the 
Food and Drug Administration of the United States (FDA) is  followed. 
Recommendations  on the processing blood products are not homogeneous. As the 
introduction of leucodepletion is currently being contemplated  in many Member 
States, consideration  should be given to laying the foundation  for a common 
European Community position regarding the efficacy  and efficiency  of this 
process, based on sound scientific  evidence, with a precise description of the 
methodology.  Finally, the approach that is taken by Member States with regard to 
informing  recipients of potentially contaminated blood products differs.  Some 
Member States do not provide any information,  one provides it to the attending, 
one considers this on a case by case basis and in others this subject  is under 
discussion. 

7.2.  Assistance to nvCJD victims  organisations 

Following the creation of a new budgetary line (B3/4308) entitled  'Support  for 
Associations seeking to help victims of Creutzfeldt-Jacob  disease', the 
Commission  services have had contacts with the Human BSE Foundation  and 
the UK authorities. 

The Commission services have written to the Human BSE Foundation  asking 
for  further  information  in order to prepare a proposal for a budgetary  transfer. 
The Commission intends to submit the transfer proposal as quickly as 
possible. 

8. 

FRA UDS AND  FINANCIAL ASPECTS 

8.1. 

Fraud:  co-ordination 

A lack of co-ordination between the police and customs services of the 
Member States was not a major  issue in this affair.  However, due to a certain 
lack of co-operation between national customs and veterinary services, 
UCLAF considered it necessary to remind the competent  authorities  appointed 
by the Member States to act as correspondents  for the application of 
Regulation  (EEC) N°  1468/81 and Regulation (EEC) N° 595/91 of the need to 
notify  the Commission of irregularities suspected or established by the 
veterinary services. 

UCLAF did make use on two occasions of its powers under the new 
Regulation  (EC) N° 2185/96 on on-the-spot checks. 

43 

The importance of future  relations between UCLAF and EUROPOL has been 
emphasised  in the Commission's  "fight  against fraud" work programme 
1997/19981 (point  1.9).  A continuing process of consultation has been 
established  in the context of Recommendation  10 of the Action Plan  approved 
by the European Council of Amsterdam  in June  1997 with regard to organised 
crime2. 
However, the EUROPOL convention has not yet been ratified  by all Member 
States. Moreover, this convention would not by itself provide a proper legal 
basis  for action in this area in the form  of a fully  co-ordinated  criminal 
investigation  among the Member States involved. 

Judicial enquiries in Belgium, the Netherlands, France and Germany are still 
ongoing. Rogatory requests from Germany, the Netherlands and Belgium have 
been sent to the Northern-Ireland  authorities.  The Commission has been 
informed  by the Dutch magistrate dealing with this matter of the intention to 
transmit, in due course, the Dutch judicial file to the Belgian examining judge 
in Brugge who is in charge of the relevant  investigations  against  one 
company. 

The enquiries undertaken by the British Ministry of Agriculture, Fisheries and 
Food have made considerable progress and a final report of the  investigations 
is expected soon. An independent  legal Counsel will then decide on the 
breaches of national and EU legislation. 

Recovery actions regarding refunds  unduly paid for exports to third  countries 
of beef of UK origin are being undertaken in France, the Netherlands  and 
Germany. 

In the framework  of the "black-list"-regulations, to date only Germany has 
reported the name of the companies involved in these cases. No such reports 
have been received from  Belgium, France or the UK. 

8.2. 

Financial  consequences  from findings on the Over Thirty Months  Scheme 
(OTMS) and the selective cull scheme, should there be justifications  of 
failures  by the UK authorities to respect Community  Regulations 

An interim report on the work undertaken by the Clearance of Accounts Unit 
in relation to the BSE measures to 31 December  1998 (Doc. No. VI/633/98 of 
5 February  1998) was forwarded  to the Budgetary Control Committee by letter 
No. 06344 of 9 February  1998. 

The report stated that in relation to the OTMS, numerous observations  and 
subsequent  recommendations have arisen from  the control missions made. The 
3 main problem  areas established by the Clearance of Accounts Unit  concern 
accounting, the control of storage, and the lack of plans for destruction of the 
majority  of the scheme material still held in storage. 

COM  (97)  199 final of  06.05.1997 
OJN°  C 251 of  15.08.1997,  page 1 

44 

Although no final position on all financial  consequences can be reached  at this 
stage by the Clearance of Accounts as regards the BSE measures, since only 
an 80% advance has been paid of the EAGGF financial  contribution to the 
OTMS, the procedure in accordance with Art. 8 of Reg. No.  1663/95 has 
already been launched concerning the weaknesses in control procedures, 
particularly in the first months of the scheme, and accounting. The first 
bilateral meeting was held in Brussels on 05 December  1997. The  formal 
notice of the results of these bilateral discussions including the requests  for 
further  information  were forwarded  to the UK authorities on  15 December 
1997. A UK reply was received on  18 February  1998. 

If the Commission services decide to propose financial consequences  after  an 
in-depth examination of the reply, which is currently being undertaken, and 
taking into account the fact that only advances have as yet been paid, the 
formal  conclusions must be notified  to the UK authorities, which will then 
have 30 working days to appeal to the conciliation body. Should this be the 
case the conciliation body then in accordance with art. 2(4) of Commission 
Decision 94/442/EC has 4 months to review the case. Only when the 
Conciliation body has finished  its work can a final proposal for an ad hoc 
decision be submitted  for consultation of the EAGGF Committee and 
subsequently  for decision by the Commission. It is expected that  after 
completion of  internal procedures a Commission decision will be adopted in 
December  1998. 

A correction in relation to the pre-1996 ,UK intervention beef, Reg. 
N°  1757/96 is also currently under consideration in light of weight  differences 
and some control deficiencies  established. This correction will be subject  to 
the same conciliation procedures as the eventual OTMS  correction. 

* 

45 

III. 

ANNEXES 

Annex  IA:  Joint  call  for  proposals  on  TSE 

JOINT  CALL FOR PROPOSALS  ON  TSE 

PL 976003 

PL 976006 

PL 976011 

PL 976013 

PL 976015 

PL 976016 

"Transgenic  mice expressing human prion protein. Use for  characterisation 
of human encephalopathies  and sensitivity for detection of infectivity".  Co 
ordinator: Professor  HAUW (FR). 
The project  intends to assess the susceptibility of a transgenic mouse carrying the 
human prion protein to classical  forms  and new variant of  Creutzfeldt-Jakob-
Disease. The project  will also validate a sensitive tool for the assessment  of 
human-derived  tissues and biological products. 
"Investigation of putative signal transduction processes of normal prion 
protein and their role in spongiform  encephalopathy  pathogenesis". Co 
ordinator: Professor  ANDERTON (UK). 
The project  intends to investigate the role of prion protein on signal  transduction 
and explore the possibility of prion protein influencing  intracellular  calcium 
concentrations. 
"In vitro investigation of PrP-induced  neurodegeneration:  development of a 
system for testing potential therapeutic agents". 
Co-ordinator: Professor  WILLIAMS (UK). 
The project  will develop an in vitro system of cultured cells in order to  investigate 
the effects  of prion protein neurotoxicity  as well as the ability of selected 
compounds to reduce or abolish these effects  of  the prion protein. 
"PrPsc distribution  and kinetics in lymphoid tissues of sheep with  natural 
scrapie: effects  on sheep PrP genotype and scrapie strains".  Co-ordinator: 
Professor  VAN KEULEN (NL). 
To study distribution and kinetics in lymphoid tissues in sheep with natural  scrapie 
using a recent developed technique based on the detection of PrPsc in tonsil 
biopsies. 
Identification  of scrapie-infected  sheep with a possible carrier status. 
Differences  between  scrapies strain endemic in the EU. 
Development  of a pre-clinical diagnostic test for scrapie using easily  accessible 
tissues. 
"European  centralised facility for human transmissible  spongiform 
encephalopathies  (prion diseases)". Co-ordinator: Professor  BUDKA (AT). 
The project  is aimed at establishing a centralised  facility  for the harmonisation  and 
quality control  of clinico-epidemiological  and neuropathological  criteria  for the 
diagnosis of human prion diseases. 
"Analysis and function  of 14-3-3 isoforms. Early diagnosis of CJD". Co 
ordinator: Professor AJTKEN (UK). 
The project  intends to establish a role for protein  14-3-3 in prion diseases and 
develop immunoassay tests as a tool for diagnosis of human prion  diseases 

46 

PL 976022 

PL 976027 

PL 976029 

PL 976030 

PL 976040 

PL 976045 

PL 976046 

PL 976048 

PL 976050 

"Role of PrP in prion spread and establishment  of central nervous  system 
infection".  Co-ordiriator: Dr DORMONT (FR). 
To study prion spread and replication: passage of prion through the intestinal 
barrier; identification  of the cell types supporting transmucosal  transport and 
primary replication  of prions after  oral  administration. 
Passage of prion through the skin; role of dendritic cells in prion  spread. 
Nature of the neuro-immune interface;  transfer  of prion from  lymphoid tissue to 
nerve cells. 
Replication  in the central nervous system and the species barrier requirements. 
Replication  in the centre nervous system and PrP expression and timing 
"The role of plasma  membrane structure and oxidative stress in prion 
propagation, transport and pathogenesis". Co-ordinator:  Professor 
KRISTENSSON  (SE). 
The project  intends to assess the role of oxidative stress in the development  of 
prion diseases. In addition, the transmission of the prion infection  from  cell to cell 
will also be studied. 
"Risk assessment in primates of TSE transmission to humans through  food 
and blood products". Co-ordinator: Professor  HUNSMANN (DE). 
The project  intends to evaluate the possibility of risk transmission of BSE to 
humans through consumption  of contaminated  food. The minimal  dose of 
infectious  agent needed to produce infection  will be assess. In addition, the  project 
intends to evaluate the risk for blood transmission of the disease. 
"TSE  spiking  experiments  for  process  validations:  evaluation  of  different 
sources  of  infectivity  and  spiking  approaches".  Co-ordinator:  Dr REICHL 
(AT). 
This  proposal  aims  at  evaluating  different  sources  of  infectivity  and  spiking 
approaches.  The proposal  also  intends  to evaluate  existing  and  emerging  in  vitro 
assays by comparing them with in vivo assays. 
"Prion diseases: mechanisms of transmission  and identification  of targets  for 
potential therapeutics." Co-ordinator: Dr COLLINGE (UK). 
This project  will aim at attempting to modify  the expression  and availability  of the 
abnormal prion protein and try to develop peptides as a potential  therapeutic 
strategy. 
"Maintenance  and transmission of yeast prions: a model system". 
Co-ordinator: Dr TUITE (UK). 
The  proposal  is  using  yeast prion  as  a  model  system  to  identify  the  key  cellular 
factors  responsible  for the maintenance  and transmission  of prion proteins. 
"Diagnosis of transmissible  spongiform  encephalopathies  using  PrPSc/PrPc 
specific  antibodies". Co-ordinator: Professor  KRETZSCHMAR  (DE). 
The proposal  aims  at  developing  diagnostic  methods  for  human  and bovine TSEs 
using PrP/PrPsc  specific  antibodies. 
"Quantitative  analysis of MR scans in CJD". Co-ordinator:  Professor 
COLCHESTER  (UK). 
The objective  of this project  is to assess the ability of magnetic resonance  as a 
diagnostic  tool for the identification  in vivo of  Creutzfeldt-Jakob-Disease  and 
compare it with the existing diagnostic procedures (clinical diagnosis and 
autopsy). The potential impact of such a project  is very high. 
"The bovine prion protein: from structure analysis to the  molecular 
mechanism  of conformational  transitions". Co-ordinator:  Professor 
SORGATO (IT). 
The project  is aimed at the identification  of the structure of the prion protein  and 
its conformational  changes. This could lead to a better understanding  of the 
mechanism  of plaque  formation  and may provide  further  insight into  further 
programmes to design therapeutic or diagnostic  agents. 

47 

PL 976051 

PL 976054 

PL 976055 

PL 976056 

PL 976057 

PL 976060 

PL 976064 

PL 976065 

"Structure, function  and interactions of prion proteins and prion protein 
domains". Co-ordinator: Professor  KRETZSCHMAR  (DE). 
This project  studies the structural  and functional  features  of the different  domains 
of the prion protein, their interactions and the conditions by which the normal 
protein becomes abnormal. 
"Development  of TSE therapies based on prion  protein-binding 
oligosaccharides". Co-ordinator: Professor  GABIZON (Israel). 
The project  is aimed at identifying  chemical compounds which interact with the 
prion protein and then determine whether they influence  TSE infection  in tissue 
culture and in TSE animal models. 
"Trafficking  pathways  of  normal  and  pathologic  isoforms  of  the  prion 
protein". Co-ordinator: Professor  LEHMANN (FR). 
The  proposal  aims  to  understand  how PrPc  converts  to PrPsc.  To  approach  this 
issue  the  proposers  will  elucidate  the  trafficking  of  PrP  and  the  molecular 
interactions that control it. 
"Concerted  action for the setting up of multicentric  epidemiological 
databases  and biological samples banks for small ruminants scrapie". Co 
ordinator: Dr LANTIER (FR). 
To create a network on the standardisation  of methods for biological  sampling 
procedures, diagnostic techniques and the collection of clinical and 
epidemiological  data. 
Setting up of infected  biological materials banks and multicentre  epidemiologies 
and data bases. 
"Building a common database on scientific  research and public decision on 
TSE in Europe". Co-ordinator: Dr JOLY (FR). 
The project  is aimed at creating a database which will include,  chronologically, 
information  on the emergence of scientific  information  on BSE and related 
disorders and the response to those developments  in the form  of research  projects 
and programmes  and in the form  of expert and official  regulations . 
"Cerebellar  networks  alterations  in prion  diseases".  Co-ordinator:  Professor 
AXELRAD (FR). 
The proposal  deals  with  the  mechanisms  of prion  induced  pathogenesis  in  TSE's 
as well as the role of normal PrPc.  The proposal will address whether  it is the loss 
of PrPc or the accumulation  of PrPsc which triggers the physiopathological  events 
in prion diseases. 
"Development  of cell culture models of infectious  forms of TSE." 
Co-ordinator: Professor LAUDE (FR). 
The  objective  of  this  proposal  is  to  develop  cell  culture  models  for  the  study  of 
PrP.  These  cell lines can be used in transfection  studies  and  in trafficking  studies 
and replace animal studies. 
"Inactivation  of 
spongiform 
encephalopathies  by  thermophilic  and  hyperthermophilic  proteases".  Co 
ordinator: Professor  RAVEN (UK). 
The aim of this proposal is to attain inactivation  of the infective  agent  ofTSE's  by 
the action of highly thermostable proteolytic  enzymes. 

the  causative  agents  of 

transmissible 

48 

Annex IB: 

Research themes 

RESEARCH THEMES 1 

P^1^^^^5^ 

4. 

Risk Assessment ofSE 's 
Proposals with a multidisciplinary  approach, including basic research, mathematical 
modelling, as well as other aspects of risk analysis, leading to quantitative risk 
assessment, will be encouraged. 

4.1.  Evaluation of SE's transmission modalities (including oral transmission) from cattle 

to man and other food animals, environmental vectors 

possible transmission through animal derived products e.g. gelatine, tallow; and 
rendering; 

transmission studies in food animals; 

-  pathogenesis of BSE  in sheep, across a range of European genotypes; 
- 

feeding  of meat and bone meal; 

search of possible factors (genetic factors)  and cofactors  (nematode  infection, 
mites, etc.). 

BIOMED (*) 
an(j 
FAIR (***) 

4.2.  Extended surveillance programme on BSE and related diseases 

FAIR  (***) 

Establishment of a European network for the epidemiological surveillance of BSE and 
related diseases aiming at assessing: e.g. 

standardisation and harmonisation of the  process and criteria  (neuropathological, 
clinical and biological diagnosis) of identification  of suspected cases; 
the incidence, geographical distribution and role of specific risk factors (genotype, 
feeding regime, exposure, environmental, etc.); 
assessment of the  surveillance system and development of quality control 
procedures; 

-  comparison of scrapie strains with BSE. 

4.3.  Determine incidence of covert disease in cattle 

FAIR  (***) 

BSE: Pre-clinical disease and latent infection in cattle, sheep and other species 
(ruminants and non-ruminants); 

-  Scrapie: Pre-clinical disease and latent infection in sheep. 

4.4.  Determine infectivity titre of cattle tissues and cattle derived products entering the 

human food chain or used in pharmaceutical  and cosmetic products. 

v 

It will also include: 

determination of infectivity  levels in human blood; 
effect  of different  processing methods of blood and blood products on  infectivity 
level; 
sheep and sheep derived products. 

4.5.  The potential exposure of human population 

Environmental  contamination: 

survival of the  agent in the environment e.g. dust, soil, rats, mice; 
safe disposal of specific  risk material; 
safe handling of meat and bone meal; 
methods of disposal: incineration, composting, rendering, biogas; 

methods of validation for effectiveness  of inactivation and handling procedures; 

BIOTECH  (**) 
j 

FATR (***) 

BIOMED (*) 

Referring  to the communication  from  the Commission on  "A  European  initiative on transmissible  spongiform 
encephalopathies"  COM(96)582 final of  13.11.1996. 

49 

effluents; 
safety of workers; 
disinfection; 
risk perception of the population in relation to exposure. 

4.6.  Determine contamination level of meat with brain/spinal cord after standard 

FAIR  (***) 

butchering procedures 

risk assessment of current diversity of slaughtering, butchering and meat recovery 
procedures in Europe; 
safety  of abattoir workers. 

4.7.  Determination of oral feeding and intracerebral  dose responses to BSE agent and 

FAIR  (***) 

whether multiple doses is cumulative 

4.8. 

Investigation of possible biological mechanisms of maternal transmission of BSE 

FAIR  (***) 

5. 

Treatment and prevention of SE's 
5.1.  Assessment and development of inactivation procedures currently used in industry 

(food, pharmaceuticals, cosmetics).  Development of alternative procedures will 
also be considered. 

6. 

Co-ordination of research activities between the Member States 

BIOTECH  (**) 

. -CSTD (***\ 

6.1.  Standardisation of case definitions  for collection of data, of data analysis and of 

BIOMED (*) and FAIR  (***) 

dissemination of information  in order to ensure a proper surveillance. 

6.2.  Harmonised procedures for early detection and diagnosis of the disease(s). 

6.3.  Continuous updating and dissemination of scientific  knowledge in this 

field. 

BIOMED (*) and FAIR  (***) 

6.4.  Fluent and rapid dissemination of these data. 

6.5.  Activation of an early warning system in case of crucial developments. 
6.6.  Exchange and mobility activities including training of research staff.  In areas 

°. 
such as diagnosis: 

J 

& 

& 

RTOMFD (*\  and  FATR (***\ 

^  ' 
r>T™ *m  /*\ 
BIOMED (*) and FAIR  (***) 

^ 
J  T- A m  /***x 

A 

> 

-  creation of network of laboratories with the aim of exchanging staff 

BIOMED (*) and FAIR  (***) 

for shorter periods,  1 -3 months. 

BIOMED (*) and FAIR  (***) 

6.7.  A continuous inventory of the progress of national research programmes. 
-  creation of a European network of national information  centres. 

6.8.  Harmonisation and control of diagnostic methods for human and animal SE's. 

BIOMED (*) and FAIR  (***) 

BIOMED (*) and FAIR  (***) 

Specific  programme of research and technological development,  including demonstration, in the field 
of Biomedicine and Health ( 1994-1998). 

Specific programme of research and technological development, including demonstration, in the field 
of Biotechnology (1994-1998. 

Specific  programme of research and technological development, including demonstration, in the field 
of Agriculture and Fisheries (including agro-iridustry, food technologies, forestry,  aquaculture and 
rural development). 

50 

Annex  2A:  Summary  and Conclusions of Missions  to all Member States  in 1997 

regarding Decision  96/449/EC 

1. 

Introduction 

On  1  April  1997 "Commission Decision 96/449/EC on the approval of 
alternative heat treatment systems for processing animal waste with a view to the 
inactivation of spongiform  encephalopathy agents" came into effect.  This 
Decision caused the major  change ever required from the animal waste industry, 
which had to comply with the requirements in the Decision within  8 months. 

Missions to all Member States (except Luxembourg which has no rendering 
industry,) were carried out from  June to December  1997.  The following  issues 
were covered by the missions: 

-  National  legislation to ensure compliance with the Decision. 

-  Processing requirements used by the rendering  industry. 

-  Use of derogations as foreseen by Article  1(2) and Article 2(5) of the 

Decision. 

-  System of official  authorisation, control and validation as foreseen  in 

Article 2(1), (2) and (3) of the Decision. 

-  Verification  on-the-spot. 

To guarantee a harmonised  inspection approach the responsible  inspectors 
developed  guidelines  for the plant visits taking into account the report of the 
Scientific  Veterinary Committee on procedures for the validation of rendering 
procedures (Doc. VI/8490/94 Rev.l). 

The draft  reports have been sent to the Member States concerned and will be 
finalised  in light of the comments received from national authorities1. 

This note gives an overview on the situation with regard to implementation  of 
Decision 96/449/EC in the European Union as a whole. Reasons and 
consequences  for cases of incomplete implementation  are described. 
Furthermore, remarks on other aspects of implementation of EU legislation in the 
field  of animal waste processing are given.  Recommendations  for  improvements 
based on the mission results are made. 

A summary of the findings  of each mission was included  in the Commission's special report  concerning 
recommendations on BSE, January 1998. 
The points have been discussed  with the Member States. 
In reference  to points 5 and 6 action has been initiated by the Commission  in order to follow  up points raised 
by the inspection service and to reconsider legislation, taking into account the latest scientific  advice, a 
working programme has been established. 

51 

2.  Results of missions 

2.1. 

State of implementation of Decision 96/449/EC: 

None of the Member States, except Finland, had fully  implemented the 
Decision, even the degree of non-compliance varied.  The shortcomings were 
severe in certain cases. 

However, it must be recognised that major  efforts  were developed by a large 
part of the industry in the Community. As regards Finland, it should be noted 
that a specific  derogation was laid down in Commission Decision  96/449/EC 
for the fur  animal industry, which eased the implementation  of the Decision. 

2.2.  Reasons of incomplete  implementation: 

There are three major reasons: 

-  The decision of certain Member States not to apply or not to fully  apply 

the Decision. 

In particular Article  1(2) of the Decision is interpreted in a way, which 
differs from the interpretation of the Commission.  Infringement  procedures 
were already opened before  the missions in these cases. 

-  The high number of rendering plants in certain Member States, which do 

not yet comply with the new legal standards and have to install new 
equipment. It was declared that difficulties  were faced by the industry to be 
supplied with adequate equipment in a relatively short  implementation 
period. 

-  Deficiencies  in the administrative  action. 

Administrative  guidance by central authorities was insufficient  or delayed 
in some cases.  In other cases the field veterinary services were deficient  by 
not following  the appropriate authorisation procedures, in particular by not 
performing  proper validation or by not inspecting the processing parameters 
or the storage and movement of improperly processed meat- and bone-meal 
in a reliable manner. 

3. 

Consequences  of incomplete  implementation 

It was observed that improperly treated meat- and bone-meal entered the animal 
feed  chain. 

Some of the material was treated according to the parameters in place  before 
Decision 96/449/EC came into effect  (see Decision 94/382/EC).  These 
treatment  standards lead to a reduction of the potential  level of TSE  agents 
present. 

Other material, in particular in cases where Member States considered it to be 
covered by the derogations of Article  1(2) of Decision 96/449/EC, was not 
treated  in accordance with any standard.  The latter material should be  considered 

52 

as not having undergone any treatment reducing the potential level of TSE agents 
present. 

Furthermore, intra-Community  trade and export to third countries of improperly 
treated material was observed.  No specific  EC rules for this trade were in place 
until Commission Decision 97/735/EC entered into force in October  1997.  In 
some cases no structures were in place to ensure further  processing or final 
destruction  of this material at the point of destination.  Where this material 
originated in Member States with cases of BSE this practice is a reason of 
particular concern.  Improperly processed material entering the feed  chain 
following  national or international trade creates serious health risks and has a 
negative impact on the TSE status of the Community as a whole. 

4.  Other  shortcomings 

Shortcomings  of a general nature identified  during inspections carried out in 
1996 have been described in a working document presented to the  Standing 
Veterinary  Committee in May  1997 (Doc. VI/2001/97).  Part of these 
deficiencies  had not been corrected.  The following  shortcomings were observed 
in the second half of 1997: 

Traceability of meat- and bone-meal was not ensured at the time of the mission. 
(It was too early to assess possible effects  of Commission Decision 97/735/EC on 
this subject). 

- 

In some Member States there is insufficient  precaution in avoiding  suspect 
BSE cases to enter the feed  chain.  (This observation was already included in 
the above-mentioned  working document  (see no. 1.3.7) and confirmed  by 
events in Germany, Belgium and Luxembourg). 

-  There are deficiencies  in the self-controls  and official  controls over the 

processing requirements of the rendering industry.  There is a lack of training 
and knowledge amongst the officials  responsible. 

In  particular,  the  validation  and  calibration  of  the  equipment  and  precautionary 
safety  devices  create  difficulties  (see  no.  1.3.6  of  the  above-mentioned  working 
document).  The  validation  procedures  defined  by  the  Scientific  Veterinary 
Committee  (see  Article  2(2)  of  Decision  96/449/EC)  are  not  helpful  to  the 
services  as  they  were  not  drafted  specifically  for  plants  working  under  the 
standards  of Decision  96/449/EC  and as they  give questionable  advice  on  certain 
control aspects, in particular concerning the particle size. 

-  Deficiencies  with regard to implementation  of Directive 90/667/EC were still 
observed  in some Member States, mainly with regard to registration of plants, 
microbiological  controls (bacteria to be tested, products to be tested,  definition 
of a batch) and general hygiene in approved plants. 

5.  Points which  need further  consideration 

The following  issues were identified  where no satisfactory  answer could be given 
to technical or legal questions arising during the missions: 

53 

a)  In some rendering plants interruption of the 20 minutes heat-treatment of single 

batches was observed.  Does Decision 96/449/EC require uninterrupted  treatment 
for 20 minutes? 

b)  Improperly treated meat- and bone-meal, derived from high risk material within 
the meaning of Directive 90/667/EEC could be included in pet-food.  Would  this 
practice be in conformity  with Article  1(2) of Decision  96/449/EC? 

c)  Article 4(1 )b of Decision 97/735/EC  sets the 31.3.1998  as the final date for  intra-

Community trade in improperly treated material designated  for reprocessing in the 
Member  State of destination.  Is it consistent  and appropriate to accept 
reprocessing  as a national  option? 

d)  Is fertiliser  containing relevant mammalian  animal waste, a product covered by the 

derogations of Article  l(2)b of Decision 96/449/EC ("products  derived  from 
mammalian  animal waste, which can be assured, will not enter any food or  feed 
chain")? If the answer is no, this would require the fertiliser  to be treated with the 
pressure  standard. 

e)  Is the exemption  for catering waste from  the requirements  of Decision  96/449/EC 
justified  (catering waste is not covered by the definition  of animal waste laid down 
in Council Directive  90/667/EEC)? 

f)  The different  status of rendering plants approved under Directive  90/667/EEC 

which may or may not be authorised under Article 2(2) of Decision  96/449/EC, 
are not reflected  by the approval numbers of most Member  States.  Would it be 
advisable to introduce an approval numbering system allowing differentiation  of 
the status of the plants? 

6.  Follow-up /  recommendations 

6.1. All efforts  should be made to achieve full  implementation  of Decision 

96/449/EC. 

6.2.  Some infraction  procedures had been opened due to lack of implementation  of 
Decision  96/449/EC  already before  the inspection  started.  On the basis of the 
inspection results further  infraction  procedures are considered by the responsible 
Commission  Service (DG VI). 

that  bone  rendering 

One  of  the  reasons  for  opening  such  a procedure  was  the  interpretation  of  some 
Member  States 
the  provisions  of 
Article 2(1)  ("pressure  cooking")  if  the  bones  were  derived  from  animals  fit  for 
human  consumption.  In light of the risks relating to the ongoing practice  of bone 
rendering without  pressure  cooking  in these Member  States and the long  duration 
of  the  infraction  procedures,  it  is recommended  to the  Commission  to  clarify  the 
scope of the derogations of Article  l(2)a of the Decision. 

is  excluded  from 

6.3. The issues raised  in n° 5 above should be  clarified. 

54 

6.4. If reprocessing of improperly treated material is accepted as a long-term  solution, 
Member States should be obliged to introduce appropriate controls to avoid 
leakage into the feed  chain. 

6.5. The Scientific  Veterinary  Committee should review its document  on validation 

procedures under the following  aspects: 

- 

- 

- 

- 

the document  should concentrate on the standards of Decision  96/449/EC; 

details concerning the day-to-day control activities should not be fixed in this 
document; 

recommendations  on the calibration  of measuring equipment  should be 
considered; 

the guidelines, should be reconsidered  with regard to the frequency and the 
tolerance for controls of the particle size. 

6.6. Certain aspects of Directive 90/667/EEC should urgently be reassessed  in light of 
developments with regard to BSE.  In particular the destruction of improperly 
treated material  for  further  processing or incineration puts in question the need of 
microbiological  testing of this material required by this Directive.  Furthermore, 
the different  hygienic and control requirements  for high risk and low risk 
processing plants are questionable.  In particular the limitation of the requirement 
to keep records and accompanying documents to high risk material within the 
meaning of Directive 90/667/EEC is critical (see Annex I n° 3 of that Directive). 

6.7. Guidelines  for official  controls of the rendering industry should be developed  and 
implemented  in all Member States.  Training should be provided to responsible 
staff to enable them to control the industry  effectively. 

6.8. The FVO should undertake follow-up  inspections.  The scope of inspections 

should be enlarged to take into account the basic Council Directive  90/667/EEC 
and EC legislation concerning international trade of raw material  and products. 
(A further  round of inspections, in particular concerning Commission  Decision 
97/735/EC  and to follow-up  deficiencies  with regard to Decision  96/449/EC  has 
been started  in early  1998). 

!>5 

Annex  2B:  Animal  waste legislation -  Working programme  1998 

The following  legislative working programme on animal waste legislation  for  1998 
was presented  and discussed  at a working group meeting of  16 April  1998. 

A. 

Commission  Decision  amending Decision  96/449/EC to take into account: 

•  Problems of legal interpretation raised during the infringements  procedures; 
•  Results of EC inspection missions; 
•  New scientific  advice on tallow and Meat-and-Bone meal. 

A draft  proposal will be discussed  at the ad hoc working group on 20 May 1998. 

B. 

Commission  Decision  amending chapter 9 (lard and rendered  fats) 
Directive 92/118/EC (trade and imports) to take into account: 

•  New scientific  advice on tallow 

A draft proposal will be discussed  at the ad hoc working group on 20 May  1998. 

C. 

Commission  Decision  laying down the animal health requirements  and 
the veterinary  certification  for the importation  of lard and rendered  fats 
from third  countries 

A draft  proposal will be discussed  at the ad hoc working group on 20 May  1998. 

D. 

Commission  Decision  laying down specific  health  conditions for the 
preparation  of gelatine intended for human  consumption 

A draft  proposal will be discussed at the ad hoc working group on 4 May  1998. 

E. 

Commission  Decision laying down the health  requirements  and the 
veterinary  certification  for the importation  of gelatine from third 
countries 

A draft  proposal will be finalised on the basis of the outcome of the ad hoc working 
group meeting on 4 May  1998. 

F. 

Council Directive amending Directive 90/667/EEC to take into  account: 

•  New scientific  advice on Meat-and-Bone Meal; 
•  Future expected scientific  advice on fallen  stock, risk assessment  on means of 

disposal of animal waste, safety of fertilisers  etc.; 

•  Outcome of the Consultation Paper on Meat-and-Bone Meal 

A draft  proposal will be finalised  as soon as the above scientific  advice will be 
available. 

56 

Annex  3: 

Current  situation  regarding  CJD and  nvCJD  cases  in the  EU 

Table  1: 

Situation  regarding  CJD as a notifiable  disease 

Member State 

Belgium 
Denmark 
Germany 

CJD notifiable 
N 
Y 
Y 

Greece 

Ireland 
Italy 

Luxembourg 
The Netherlands 
Austria 
Portugal 
Finland 
Sweden 
United Kingdom 

Y 

Y 
N 

Y 
N 
Y 
Y 
N 
Y 
N 

date of onset 

definition 

05/1997 
07/1994 

09/1996 

12/1996 

06/1997 

04/1996 
06/1996 

intended 
all suspected cases of CJD 
probable and confirmed  cases of 
sporadic CJD + HSE not linked with 
familiar  or hereditary history (GSS 
excluded) 
all suspected cases of CJD 

all suspected cases of CJD + other 
Human  Spongiform 
Encephalopathies (GSS, FFI) 
confirmed  cases of all CJD 
possibility to include CJD in the 3rd 
class of the reporting system 
all suspected cases of CJD 

confirmed  cases of all CJD 
all suspected cases of CJD 

04/1998 

Criteria not yet known 

57 

Table 2:  Number of cases referred to the diagnostic Centre for CJD assessment 

Total number (<50 years) 

1990 

4(0) 

1991 

3(0) 

1992 

3(0) 

1993 

5(0) 

1994 

5(0) 

4(0) 

1995 

6(1) 

5(0) 

1996 

6(1) 

5(0) 

1997 

7(1) 

13(4) 

36(0) 

148(17) 

142(15) 

192(29) 

181  (14) 

59(6) 

19(4) 

55(3) 

21(1)) 

85(12) 

25(1) 

3(1) 

29(3) 

4(0) 

27(1) 

104(14) 

196(34) 

347(94) 

Belgium 

Denmark 

Germany 

Greece 

Spain 

France 

Ireland 

Italy 

51(7) 

62(11) 

13(3) 

1(0) 

15(1) 

3(2) 

•52(6) 

1(1) 

6(0) 

2(0) 

2(0) 

1(0) 

12(0) 

12(1) 

•78(11) 

116(12) 

14(0) 

86(16) 

6(0) 

77(13) 

1(0) 

22(4) 

9(0)** 

2(0) 

10(1) 

12(1) 

138(22) 

16(2) 

38(4) 

8(0) 

10(4) 

18(2) 

133(44) 

151(46) 

Luxembourg 

The Netherlands 

1 

Austria 

Portugal 

/Finland 

Sweden 

United Kingdom 

** since July 1, 1996 only 

5(0) 

2(0) 

15(1) 

53(6) 

8(0) 

75(4) 

"i 

3(0) 

3 

6(0) 

96(9) 

â 

Table 3:  Approach  towards the safety of blood products 

Member State 

Selection of Donors 

Belgium 

Denmark 

Germany 

Greece 

Spain 

France 

Ireland 

Exclusion  of: 
- familial  history of CJD 
- past record of neurosurgery 
- history of growth hormone or dura mater transplant 

The danish blood donor system is a passive one. The blood donors are volonteers. The donors are asked 
about their personal  and family  anamnesis in relation to diseases and about risk behaviour. 

3 criteria for exclusion: 
- history of growth hormone treatment 
- familial  history of CJD 
- dura mater or cornea transplant 

Legally binding criteria for exclusion: 
- persons treated with human pituitary glands or products (November  1994) 
-  persons who received cornea or duramater transplantation(October  1997) 
-  persons  with a history of familial  TSEs (October  1997) 

By law (7/02/1996), exclusion  of: 
- persons treated with human pituitary hormones or dura mater products; 
- familial  history of CJD 

Exclusion  of: 
- persons having received non secured biological  products 
- past treatment with human growth hormones or other comparable products 
- history of neurosurgery 
- history of familial TSEs 

Donor questionnaire with questions related to : 
- medical procedures undergone within the previous  12 months 
- neurosurgery undergone at any stage 
- family history of CJD 
- treatment with human pituitary growth hormones or comparable products 
- corneal transplants 

Italy 

Luxembourg 

WHO exclusion criteria 

Criteria defined  for selection of donors: 
- persons with CJD of GSS 
- persons with familial history (1st degree) of CJD or GSS 
- persons with duramater or cornea transplantation 
- persons treated with human pituitary growth hormones or comparable products 

The Netherlands 

Exclude subjects with a positive family  history 

Austria 

Portugal 

Finland 

Sweden 

. 

United Kingdom 

WHO exclusion criteria 

General rules for selection of donors, plus exclusion of recipients of dura mater transplantation 

Follows the Council of Europe recommendations 

History of CJD in family is asked 

Exclusion  of: 
- persons with diseases of the central nervous system 
- persons treated with human growth pituitary hormone 
- recipients of human gonadotrophin of pituitary origin 
- persons injected  with human pituitary extract before  1985 
- persons with a family history of CJD (direct blood-line relatives) 

59 

Member  State 

Approach  regarding  contaminated  products 

Belgium 

Denmark 

Germany 

Greece 

Spain 

France 

Ireland 

Italy 

Follows the EMEA policy 

Possibly contaminated products will be drawn back. Any precaution which apply 
for the whole blood will apply as well as for any later processed and/or secured 
product. 

Follows the EMEA policy. In case of a suspicion of nvCJD, all products are 
withdrawn. For familial or sporadic CJD, same rules except for plasma products 

Measures to be introduced by the National Medicines Organisation 

No withdrawing of classical CJD contaminated products; withdrawal of nv-CJD 
contaminated products 

Withdrawal and destruction of all products coming from an at-risk donor. 
Withdrawal of medicinal products derived from material coming from TSE cases 

Follows the policy adopted by FDA 

Details still to be supplied 

Luxembourg 

Withdrawal of possibly contaminated products 

The Netherlands 

Withdrawal of possibly contaminated products 

Austria 

Portugal 

Finland 

Sweden 

Details still to be supplied 

Details still to be supplied 

Follows the guideline of CPMP for possibly contaminated products 

Details still to be supplied 

United Kingdom 

Follows the guideline of CPMP for possibly contaminated products 

Member  State 

Recommendations  on processing  of blood  products 

Belgium 

Denmark 

Germany 

Greece 

Spain 

France 

Ireland 

Italy 

Luxembourg 

Follows the blood products safety rules 

Possibly contaminated products will be drawn back. Any precaution which 
apply for the whole blood will apply asa well as for any later processed 
and/or secured product. 

Leucocyte filtration  under discussion 

Follows the EC blood product safety rules 

Follows the CPMP recommendations: 
- no use of plasma or derived products coming from an area where nv-CJD 
cases have been identified 

Leucocyte filtration for blood products will be implemented in April 98 

Implementation of universal leucodepletion of blood and blood 
components under study 

Possibly contaminated products are withdrawn 

The Netherlands 

No advice 

Question still under examination 

Austria 

Portugal 

Finland 

Sweden 

No answer (to be checked) 

Filtration of blood recommendation 

Possibly contaminated products are withdrawn 

To be withdrawn 

United Kingdom 

Standard safety precautions applied. Leucodepletion is under consideration. 

61 

Member  State 

Information  to possibly  contaminated  persons 

Belgium 

France 

Denmark 

Under discussion 

No direct information, but traceability ensured by an indication in the 
patient's  'dossier' 

If a bloodproduct is found to be positive for Hiv, Hepatitis B and/or C a 
look-back investigation will be performed,  and an eventually individual 
information  will be given by the bloodbanks at the hospitals. If information 
is not given, it must be extremely unlike that there are any risk for the 
recipient. 

Germany 

Under discussion 

Greece 

Spain 

Ireland 

Italy 

Considered case by case. 

No direct  information 

Currently no notification  of recipients of possibly contaminated products 

No information, because it is devoid of any practical  usefulness 

Luxembourg 

No direct information, but traceability ensured by an indication in the 
patient's "dossier" 

The Netherlands 

No information  unless transmission has been shown in the past 

Austria 

Portugal 

Finland 

Sweden 

Information  still to be supplied 

No  information 

Considered case by case 

Follow up of patients. Information to the attending physician 

United Kingdom 

Only epidemiological study is undertaken for such cases 

62 

Figure  1 : total of Definite and probable  CJD cases  ; years  1995, 1996, 1997 

Annex 4:  List of themes  covered by the present  report in the light of the  "Boge report" of the  European 

Parliament,  in addition to the action promised  in document  COM(97) 509 final 

Publicising the results of the Scientific  Committees 

SRM 

MBM: safety  of inactivation  processes 

Destruction of MBM 

Post mortem BSE tests 

OTMS inspection (9-11 February  '98) 

Implementation of Community  law/inspections/infringements 

Co-decision  procedure 

Labelling of compound  feedingstuffs 

Landfill 

Entry into force of Regulation EC/820/97 (beef labelling) 

MBM safety  standards + general  standards in the OIE 

Hormones, feedingstuffs  additives 

Assistance to nvCJD victims  organisations 

Frauds: co-ordination 

(j°l 

ISSN 0254-1475 

COM(98) 282 final 

DOCUMENTS 

EN 

03  15  10  05 

Catalogue  number  :  CB-CO-98-304-EN-C 

ISBN  92-78-35977-7 

Office  for  Official  Publications  of the European  Communities 

L-2985  Luxembourg 

\â°)