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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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TABLE OF CONTENTS 
I. AVANT-PROPOS 6 
II. ACTION UNDERTAKEN BY THE COMMISSION CONCERNING BSE/TSE SINCE 
NOVEMBER 1997 7 
1. SCIENTIFIC ASPECTS 7 
1.1. Scientific committees : procedures • 7 
i) Nomination of Scientific Committee members 7 
ii) Publicising the results of the scientific committees 7 
iii) Acceleration of payment procedures for the members of the Scientific Committees - Payment 
of indemnity of SC members 7 
1.2. Scientific advice 8 
i) Scientific Steering Committee to discuss list of Specified Risk Material (SRM) and abolition 
of age limits on exclusion of younger animals 8 
ii) Meat and Bone Meal (MBM): Safety of inactivation processes 9 
iii) Destruction of MBM 9 
iv) Post mortem BSE tests 9 
1.3. Research activities 10 
i) Adoption by the Commission of projects on TSE research following the 29tn April 1997 joint 
call for proposals 10 
ii) Organisation and completion of study of methods to establish quantity and quality of feed 
materials in compound feedstuffs 12 
2. INSPECTIONS 14 
2.1. Legal framework 14 
i) Replacement of two Commission Decisions relating to performance of on-the-spot checks 14 
ii) Co-operation with Member States (Directive 89/608/EEC) 15 
2.2. The Food and Veterinary Office (FVO) 16 
i) Receipt of, and response to, IGS report 16 
ii) Recruitment of staff under the Supplementary and Amending Budget (SAB) 1997 -
Additional increase in staff numbers in FVO 16 
iii) Development of internal manual of procedures by FVO 17 
2.3. BSE inspections 17 
i) Further follow-up missions concerning the reporting of all BSE cases 
(Germany, Italy and Sweden) 17 
ii) Over Thirty Months Scheme (OTMS inspection (9-11 February '98)) 17 
3. IMPLEMENTATION OF COMMUNITY LAW 17 
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 17 
3.2. Implementation of Community law/inspections/infringements with regard to BSE: 
overall situation IS 
3.3. New information obtained by the FVO inspectors with regard to implementation 
of Decision 96/449/EC 24 
4. SITUATION WITH REGARD TO THE UK BEEF BAN 25 
Ji' 3 
'1 
4.1. Submission to the European Parliament of the report of the mission to the 
UK 9- 13.6.97 25 
4.2. Appropriate action on the basis of scientific advice on the UK's Export Certified 
Herd Scheme (ECHS) 25 
4.3. The UK proposal on a Date-Based Export Scheme (DBES) 26 
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 26 
5. LEGISLATION 27 
5.1. Co-decision procedure 27 
5.2. General legislative measures 28 
i) Assessment of further changes to Directive 85/374/EEC 28 
ii) Food policy and the general principles of Food Law 29 
iii) Completion of simplification exercise on food hygiene legislation, including veterinary and 
phytosanitary legislation 29 
iv) Entry into force of regulation EC/820/97 (beef labelling) 29 
5.3. Reinforcement of controls in the European Union 30 
5.4. Surveillance and control of communicable diseases and other health issues 32 
i) Establishment of a Community network for the surveillance and control of communicable 
diseases and of an action programme on rare diseases 32 
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 34 
iii) Proposal on effective surveillance of TSEs in animals in the Member States 35 
5.5. Exclusion of risk material from the food and feed chain 35 
i) Commission consultation paper on exclusion of high risk material from the feed chain and 
on a ban on feeding animal protein to ruminants 35 
ii) Adoption of a feed ban on MBM not produced in accordance with the standards of 
Decision 96/449/EC and restriction on use 36 
iii) SRM: Proposal to exclude specific hazardous materials from the human or animal food chain 36 
iv) Labelling of compound feedingstuffs 37 
v) Destruction of MBM / Landfill : 37 
6. INTERNATIONAL ASPECTS ...38 
6.1. Participation, collaboration and membership of the Commission in international 
organisations 38 
6.2. MBM safety standards + general standards in the OIE 38 
6.3. Hormones, feedingstuffs additives 39 
7. NVCJD VICTIMS: CURRENT SITUATION AND ASSISTANCE TO NvCJD VICTLMS 
ORGANISATIONS 41 
7.1. Current situation regarding CJD and nvCJD cases in the EU 41 
7.2. Assistance to nvCJD victims organisations 43 
8. FRAUDS AND FINANCIAL ASPECTS 43 
8.1. Fraud: co-ordination 43 
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 44 
III. ANNEXES 46 
ANNEX 1A: JOINT CALL FOR PROPOSALS ON TSE 46 
ANNEX IB: RESEARCH THEMES 49 
ANNEX 2A: SUMMARY AND CONCLUSIONS OF MISSIONS TO ALL MEMBER STATES IN 1997 
REGARDING DECISION 96/449/EC 51 
ANNEX 2B: ANIMAL WASTE LEGISLATION- WORKING PROGRAMME 1998 56 
ANNEX 3: CURRENT SITUATION REGARDING CJD AND NVCJD CASES IN THE EU 57 
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 COM(97) 509 FINAL 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. clinical, social and epidemiological research on human spongiform 
encephalopathies (SEs); 
2. the infectious agent and its transmission mechanisms; 
3. diagnosis of SEs; 
4. risk assessment of SEs; 
5. treatment and prevention of SEs; 
6. 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. treatment and prevention of SEs; 
3. 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 "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. 
PL 976006 "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. 
PL 976011 "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. 
PL 976013 "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. 
PL 976015 "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. 
PL 976016 "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 "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 
PL 976027 "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. 
PL 976029 "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. 
PL 976030 "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. 
PL 976040 "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. 
PL 976045 "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. 
PL 976046 "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. 
PL 976048 "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. 
PL 976050 "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 "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. 
PL 976054 "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. 
PL 976055 "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. 
PL 976056 "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. 
PL 976057 "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 . 
PL 976060 "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. 
PL 976064 "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. 
PL 976065 "Inactivation of the causative agents of transmissible 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. 
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 BIOMED (*) 
to man and other food animals, environmental vectors an(j 
possible transmission through animal derived products e.g. gelatine, tallow; and FAIR (***) 
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.). 
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 BIOTECH (**) 
human food chain or used in pharmaceutical and cosmetic products. v j 
It will also include: FATR (***) 
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 BIOMED (*) 
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; 
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 BIOTECH (**) 
(food, pharmaceuticals, cosmetics). Development of alternative procedures will . -CSTD (***\ 
also be considered. 
6. Co-ordination of research activities between the Member States 
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. 
RTOMFD (*\ and FATR (***\ 
6.5. Activation of an early warning system in case of crucial developments. ^ ' A ^ > 
6.6. Exchange and mobility activities including training of research staff. In areas r>T™ *m /*\ J T- A m /***x 
°. J & & BIOMED (*) and FAIR (***) 
such as diagnosis: 
- 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). 
One of the reasons for opening such a procedure was the interpretation of some 
Member States that bone rendering is excluded from 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. 
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 
Greece CJD notifiable 
N 
Y 
Y 
Y date of onset 
05/1997 
07/1994 
09/1996 definition 
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 
Ireland Y 12/1996 
Italy N 
Luxembourg Y 06/1997 
The Netherlands N 
Austria Y 04/1996 
Portugal Y 06/1996 
Finland N 
Sweden Y 04/1998 
United Kingdom N 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 
Criteria not yet known 
57 
Table 2: Number of cases referred to the diagnostic Centre for CJD assessment 
Total number (<50 years) 
Belgium 
Denmark 
Germany 
Greece 
Spain 
France 
Ireland 
Italy 
Luxembourg 
The Netherlands 
Austria 
Portugal 
/Finland 
Sweden 
United Kingdom 1990 
4(0) 
1 
5(0) 
15(1) 
53(6) 1991 
3(0) 
2(0) 
8(0) 
75(4) 1992 
3(0) 
59(6) 
"i 
3(0) 
3 
6(0) 
96(9) 1993 
5(0) 
36(0) 
19(4) 
55(3) 
51(7) 
13(3) 
2(0) 
12(0) 
•78(11) 1994 
5(0) 
4(0) 
148(17) 
21(1)) 
85(12) 
62(11) 
1(0) 
15(1) 
2(0) 
12(1) 
116(12) 1995 
6(1) 
5(0) 
142(15) 
25(1) 
104(14) 
3(2) 
•52(6) 
1(1) 
6(0) 
1(0) 
14(0) 
86(16) 1996 
6(1) 
5(0) 
192(29) 
3(1) 
29(3) 
196(34) 
6(0) 
77(13) 
1(0) 
22(4) 
9(0)** 
2(0) 
10(1) 
133(44) 1997 
7(1) 
13(4) 
181 (14) 
4(0) 
27(1) 
347(94) 
12(1) 
138(22) 
16(2) 
38(4) 
8(0) 
10(4) 
18(2) 
151(46) 
** since July 1, 1996 only 
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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 
The Netherlands 
Austria 
Portugal 
Finland 
Sweden . 
United Kingdom 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 
Exclude subjects with a positive family history 
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 
Luxembourg 
The Netherlands 
Austria 
Portugal 
Finland 
Sweden 
United Kingdom 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 
Withdrawal of possibly contaminated products 
Withdrawal of possibly contaminated products 
Details still to be supplied 
Details still to be supplied 
Follows the guideline of CPMP for possibly contaminated products 
Details still to be supplied 
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 
The Netherlands 
Austria 
Portugal 
Finland 
Sweden 
United Kingdom 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 
Question still under examination 
No advice 
No answer (to be checked) 
Filtration of blood recommendation 
Possibly contaminated products are withdrawn 
To be withdrawn 
Standard safety precautions applied. Leucodepletion is under consideration. 
61 
Member State Information to possibly contaminated persons 
Belgium 
France 
Denmark 
Germany 
Greece 
Spain 
Ireland 
Italy 
Luxembourg 
The Netherlands 
Austria 
Portugal 
Finland 
Sweden 
United Kingdom 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. 
Under discussion 
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 
No direct information, but traceability ensured by an indication in the 
patient's "dossier" 
No information unless transmission has been shown in the past 
Information still to be supplied 
No information 
Considered case by case 
Follow up of patients. Information to the attending physician 
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 
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