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"B COMMISSION DECISION
of 23 April 1998
on epidemio-surveillance for transmissible spongiform encephalopathies and amending Decision 94/474/EC
(Text with EEA relevance)
(98/272/EC)
(OJ L 122, 24.4.1998, p. 59)
Amended by:
Official Journal
No page date
"M1 Commission Decision 2000/374/EC of 5 June 2000 L 135 27 8.6.2000
"M2 Commission Decision 2000/764/EC of 29 November 2000 L 305 35 6.12.2000
"M3 Commission Decision 2001/8/EC of 29 December 2000 L 2 28 5.1.20011998D0272 — EN — 01.01.2001 — 001.002 — 1
COMMISSION DECISION
of 23 April 1998
on epidemio-surveillance for transmissible spongiform encephalopathies
and amending Decision 94/474/EC
(Text with EEA relevance)
(98/272/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 89/662/EEC of 11 December 1989
concerning veterinary checks in intra-Community trade with a view to thecompletion of the internal market (
1), as last amended by Directive
92/118/EEC (2), and in particular Article 9(4) thereof,
Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning
veterinary and zootechnical checks applicable in intra-Community trade in
certain live animals and products with a view to the completion of the internalmarket (
3), as last amended by Directive 92/118/EEC, and in particular Article
10(4) thereof,
(1) Whereas new information has been published in the United Kingdom
further supporting the hypothesis that exposure to the bovinespongiform encephalopathy (BSE) agent is linked to the new variantof Creutzfeldt Jacob Disease (CJD) in humans; whereas on 16
September 1997 the Spongiform Encephalopathy Advisory Committee
(SEAC) of the United Kingdom concluded that recent researchprovided compelling new evidence that the agent which causes BSE is
identical to the agent which causes the new variant of CJD in humans;
whereas on 18 September 1997 the Advisory Committee on DangerousPathogens (ACDP) concluded that the BSE agent should now beclassified as a human pathogen under Directive 90/425/EEC, the
Member State of origin or dispatch is required to implement on its
territory the appropriate measures to prevent all situations likely toconstitute a serious hazard to animals or to human health;
(2) Whereas, pursuant to Council Directive 82/894/EEC (
4), as last
amended by Commission Decision 98/12/EC (5), Member States have
since 1990 been obliged to notify all cases of BSE to the Commissionand to the other Member States;
(3) Whereas pursuant to Council Directive 91/68/EEC (
6), as last amended
by Commission Decision 94/953/EC (7), since 1993 scrapie must be an
officially notifiable disease in all Member States;
(4) Whereas the Scientific Veterinary Committee has stated on the basis of
its risk assessment that several Member States including the UnitedKingdom have reported scrapie in native-born sheep, that the presence
of scrapie cannot be excluded in any Member State where sheep are
present and that only a thorough epidemiological investigationconducted to common standards will give the necessary informationabout the scrapie status of each country;
(5) Whereas inspections were carried out in Member States in 1996 and
1997 to check the implementation of Community measures on BSE;
whereas the results of those inspections have revealed certaindeficiencies, in particular in surveillance and implementation of the
prohibition on use of mammalian protein in ruminant feed;
(6) Whereas in view of previous trade in certain products, in particular
meat and bone meal and live animals, the possible presence oftransmissible spongiform encephalopathy (TSE) agents cannot be!B
(1) OJ L 395, 30. 12. 1989, p. 13.
(2) OJ L 62, 15. 3. 1993, p. 49.
(3) OJ L 224, 18. 8. 1990, p. 29.
(4) OJ L 378, 31. 12. 1982, p. 58.
(5) OJ L 4, 8. 1. 1998, p. 63.
(6) OJ L 46, 19. 2. 1991, p. 19.
(7) OJ L 371, 31. 12. 1994, p. 14.1998D0272 — EN — 01.01.2001 — 001.002 — 2
ruled out in any of the Member States, subject to further scientific
evaluation;
(7) Whereas the World Organisation for Animal Health (Office Inter-
national des Epizooties (OIE)) in its international animal health codeon bovine spongiform encephalopathy of May 1997 has recommendedminimum requirements for effective surveillance; whereas the OIE has
adopted guidelines for continuous surveillance and monitoring of
bovine spongiform encephalopathy in its Code of January 1997;
(8) Whereas the Scientific Veterinary Committee in its report on
surveillance of transmissible spongiform encephalopathies of 11 June1997 has laid down guidelines taking account of the recommendationsof the OIE;
(9) Whereas the measures provided for in this Decision are in accordance
with that opinion and represent a harmonised approach towards
effective TSE surveillance in the Member States; whereas more
detailed rules will be laid down in Council legislation based on Article100a of the Treaty;
(10) Whereas the measures provided for in this Decision will be applied in
conjunction with Commission Decision 97/534/EC of 30 July 1997 on
the prohibition of the use of material presenting risks as regards
transmissible spongiform encephalopathies (
1), as last amended by
Council Decision 98/248/EC (2);
(11) Whereas investigation requirements for ante-mortem inspection in
slaughterhouses of bovine animals were laid down in CommissionDecision 94/474/EC (
3), as last amended by Council Decision
98/256/EC (4); whereas those requirements are now set out in this
Decision; whereas, therefore, the corresponding provisions of Decision94/474/EEC should be deleted;
(12) Whereas the measures provided for in this Decision are in accordance
with the opinion of the Standing Veterinary Committee,
HAS ADOPTED THIS DECISION:
Article 1
Member States shall ensure that staff of the competent authority, of diagnostic
laboratories and colleges of agriculture and veterinary medicine, officialveterinarians, veterinary practitioners, slaughterhouse personnel and animalbreeders, keepers and handler have the knowledge of the clinical signs,
epidemiology and, as appropriate, laboratory findings relating to TSEs.
Article 2
1. Member States shall ensure that it is compulsory for the suspected
presence of any TSE in any animal to be notified immediately to the
competent veterinary authority.
2. BSE shall be suspected in bovine animals aged over 20 months displaying
behavioural or neurological signs where the disease cannot be ruled out eitheron the basis of response treatment or following laboratory examination.
3. Scrapie shall be suspected in ovine and caprine animals aged over 12
months displaying behavioural or neurological signs where the disease cannot
be ruled out either on the basis of response to treatment or following
laboratory examination.
Article 3
1. Any animal which shows clinical signs giving rise to the suspicion of a
TSE shall be placed under official movement restrictions pending theoutcome of a clinical and epidemiological investigation by the competentauthority.!B
(1) OJ L 216, 8. 8. 1997, p. 95.
(2) OJ L 102, 2. 4. 1998, p. 26.
(3) OJ L 194, 29. 7. 1994, p. 96.
(4) OJ L 113, 15. 4. 1998, p. 32.1998D0272 — EN — 01.01.2001 — 001.002 — 3
2. Where the competent authority decides that the possibility of infection
with a TSE cannot be ruled out, the animal shall be killed and its brain andsuch other tissues as the competent authority may determine shall be removedand sent to an approved laboratory for testing for the presence of TSE using
the methods set out in Article 5.
"M1All parts of the body of the suspect
animal, including the hide, shall be retained under official supervision until anegative diagnosis has been made or until it has been destroyed byincineration or, under exceptional circumstances, burned or buried in strict
compliance with the conditions laid down in Article 3(2) of Council Directive
90/667/EEC (
1).3
Article 4
1. In order to give early warning of the emergence or occurrence of BSE or
scrapie, each Member State shall carry out an annual programme of
monitoring in accordance with the conditions laid down in "M1Annex I 3.
2. Member States shall submit an annual report to the Commission covering
at least the information referred to in Annex II, part A. The report for eachcalendar year shall be submitted at the latest by 31 March of the following
year. The Commission shall present a summary of the country reports for each
period covering at least the information referred to in Annex II, part B, to theStanding Veterinary Committee within three months of the receipt of thecountry reports.
3. Member States shall ensure that all official investigations and laboratory
examinations are recorded in accordance with Annex III.
Article 5
1. Sampling and laboratory testing for the presence of BSE in bovine
animals shall be carried out using the methods and protocols laid down inAnnex IV . Sampling and laboratory testing for the presence of scrapie insheep shall be carried out using the methods and protocols laid down in the
Manual of Standards for Diagnostic Tests and Vaccines of the World
Organisation for Animal Health (Office international des épizooties), May1999 edition.
2. The national reference laboratory in each Member State, as set out in
Annex V , shall ensure coordination of diagnostic methods and protocols
between the laboratories approved for testing for the presence of TSEs and
regularly verify the use of those diagnostic methods and protocols.
Article 6
Community inspections may be carried out, in particular where the annual
report is not submitted in accordance with Article 4(2).
Article 7
Article 2 of Decision 94/474/EC is hereby deleted.
Article 8
This Decision shall apply from 1 May 1998.
Article 8a
Without prejudice to Article 4(2), Member States shall submit a report
covering January-June 2001 including at least the information referred to inAnnex II, part A, to the Commission by 1 October 2001, at the latest.
The provisions of Annex I and II shall be reviewed every six months in the
light of the results of the monitoring and experience gained in implementing
the programme. The provisions of Annex IV shall be reviewed in the light of
the development of the Manual of Standards for Diagnostic Tests andVaccines of the World Organisation for Animal Health (Office internationaldes épizooties). The provisions of Annex IVA shall be reviewed in the light of
further evaluation of diagnostic methods.!B
(1) OJ L 363, 27.12.1990, p. 51.!M1
!B
!M11998D0272 — EN — 01.01.2001 — 001.002 — 4
Article 9
This Decision is addressed to the Member States.!B1998D0272 — EN — 01.01.2001 — 001.002 — 5
ANNEX I
A. MINIMUM REQUIREMENTS FOR A PROGRAMME FOR MONITOR-
ING BSE IN BOVINE ANIMALS
1. Selection of sub-populations
Dead bovine animals over 30 months of age not slaughtered for human
consumption (excluding animals referred to in Commission Regulation (EC) No
716/96).
2. Sample size
The number of samples tested annually in each Member State from the
subpopulation referred to in point 1 shall not be less than the sample sizesindicated in the table. The selection of samples shall be random. The samplingshall be representative for each region and continuous.
Total population over 30 months (
1) Sample size (2)
100 000 950
200 000 1 550
300 000 1 890
400 000 2 110
500 000 2 250
600 000 2 360700 000 2 440
800 000 2 500
900 000 2 550
1 000 000 2 590
1 500 000 3 000
2 000 000 3 5002 500 000 4 000
3 000 000 4 500
3 500 000 5 0004 000 000 5 500
4 500 000 6 000
5 000 000 6 5005 500 000 7 000
6 000 000 7 500
6 500 000 8 0007 000 000 8 500
7 500 000 9 000
8 000 000 9 5008 500 000 10 000
9 000 000 10 500
9 500 000 11 000
10 000 000 11 500
10 500 000 12 000
11 000 000 12 50011 500 000 13 000!
M1
!M21998D0272 — EN — 01.01.2001 — 001.002 — 6
Total population over 30 months (1) Sample size (2)
12 000 000 13 500
(1)Where the size of the total population over 30 months of age is not known, the
population over 24 months of age shall be used instead.
(2)The sample size has been calculated to detect a prevalence of 0,1 % with a 95 %confidence in the sub-population referred to in point 1, based on the assumption that
the proportion of this sub-population in the total population of bovine animals over
30 months of age is 1 %. Where the size of the total population of bovine animals
over 30 months of age is 1 500 000 animals or more, the sample size has been
increased by 500 samples per 500 000 animals as a proportionality adjustment, totake account of the larger likelihood of variation in risk for BSE within the
population.
B. MINIMAL REQUIREMENTS FOR A PROGRAMME FOR MONITORING
SCRAPIE IN OVINE AND CAPRINE ANIMALS
1. Selection of sub-populations
Selection must be by means of a risk assessment of sub-populations of native-
born animals displaying clinical signs compatible with scrapie. Within each
sub-population and age group, selection must be random.
The following shall be the criteria for the selection:— animals displaying behavioural or neurological signs lasting for at least 15
days and resistant to treatment,
— moribund animals without signs of infectious or traumatic illness,— animals displaying other progressive disease conditions.
2. Age of targeted animals
The sample must target the oldest animals in the sub-population. However, all
targeted animals must be over 12 months of age.
3. Sample size
The minimum number of animals to be examined on an annual basis must
comply with the sample sizes referred to in the table. Animals examined inaccordance with Article 3 may be included within the minimum sample size.
Table
Minimum number of annual neurohistological investigations of animals
showing clinical signs compatible with scrapie
Total population over 12 months (
1) Sample size
100 000 10
300 000 30
500 000 50700 000 69
1 000 000 99
2 500 000 1955 000 000 300
7 000 000 336
10 000 000 36720 000 000 409
30 000 000 425
40 000 000 433
(
1)Where the size of the total population over 12 months of age is not known, the sample
size shall be based on the total population over six months of age.!M2
!M11998D0272 — EN — 01.01.2001 — 001.002 — 7
C. MONITORING IN HIGHER RISK ANIMALS
Monitoring in higher risk animals
In addition to the monitoring programmes set out in parts A and B, Member States may
on a voluntary basis carry out targeted surveillance for TSEs in higher risk animals,such as:
— animals originating from countries with indigenous TSE,— animals which have consumed potentially contaminated feedingstuffs,
— animals born or derived from TSE infected dams.
D. COMMON PROVISIONS
Member States shall ensure that no parts of the body of animals sampled pursuant to
this Annex are used for human food, animal feed, fertilisers, cosmetic or medicinalproducts or medical devices until the laboratory examination has been concluded withnegative results.!
M11998D0272 — EN — 01.01.2001 — 001.002 — 8
ANNEX II
A. INFORMATION TO BE PRESENTED IN THE REPORT BY MEMBER
STATES
1. The number of suspected cases per animal species placed under movement
restrictions in accordance with Article 3(1).
2. The number of suspected cases per animal species subject to laboratory
examination in accordance with Article 3(2) and the outcome of theexamination.
3. The estimated size of the sub-population referred to in Annex I(A)(1).
4. The number of bovine animals tested within each sub-population as referred to
in Annex I(A)(1), Annex I(C) and Article 1 to Decision 200/764/EC, method forsample selection and the outcome of the tests.
5. The number of ovine and caprine animals examined within each sub-population
as referred to in Annex I(B)(1) and Annex I(C) and the outcome of theexamination.
6. Number, age distribution and geographical distribution of positive cases of BSE
and scrapie. The year and, where possible, month of birth should be given forBSE cases born after the introduction of a feed ban.
7. Positive TSE cases confirmed in animals other than bovine, ovine, and caprine
animals.
B. INFORMATION TO BE PRESENTED IN THE SUMMARY BY THE
COMMISSION
The summary shall be presented in a tabled format covering at least the information
referred to in part A for each Member State.!
M21998D0272 — EN — 01.01.2001 — 001.002 — 9
ANNEX III
RECORDS
1. The competent authority shall keep records of
— the number and types of animals placed under movement restrictions as
referred to in Article 3(1),
— the number and outcome of clinical and epidemiological investigations as
referred to in Article 3(1),
— the number and outcome laboratory examinations as referred to in Article
3(2),
— the number, identity and origin of animals sampled in the framework of the
monitoring programmes as referred to in Annex I and, where possible, age,
breed and anamnestic information.
The records shall be kept for seven years.
2. The investigating laboratory shall keep all records of testing, in particular
laboratory workbooks, paraffin blocks and, where appropriate, photographs of
Western blots.
The records shall be kept for seven years.!M11998D0272 — EN — 01.01.2001 — 001.002 — 10
ANNEX IV
SAMPLING AND LABORATORY TESTING FOR THE PRESENCE OF BSE IN
BOVINE ANIMALS
1. Collection of samples
The competent authority shall ensure that samples ae collected using the
methods and protocols laid down in the Manual of standards for diagnostic testsand vaccines of the World Organisation for Animal Health (Office Internationaldes Epizooties), latest edition. In the absence of such methods and protocols, thecompetent authority shall ensure that the samples are collected in a manner
appropriate for the correct application of tests.
The competent authority shall ensure that samples are correctly marked as to the
identity of the sampled animal.
2. Laboratory testing
2.1. Suspect cases
Tissues from bovine animals sent for laboratory testing pursuant to the
provisions of Article 3(2) shall be subject to a histopathology examination aslaid down in the Manual of standards for diagnostic tests and vaccines of theWorld Organisation for Animal Health (Office International des Epiziooties),latest edition, except where the material is autolysed. Where the result of the
histopathology examination is inconclusive or negative or where the material
autolysed, the tissues shall be subjected to an examination by one of the otherdiagnostic methods laid down in the above Manual (immunocytochemistry,immuno-blotting or demonstration of characteristic fibrils by electronmicroscopy).
2.2. Animals examined in the framework of the annual monitoring programme or
subject to routine examination at slaughter
Bovine animals examined in the framework of the annual monitoring
programme as laid down in Annex I(A), the targeted surveillance programme
as laid down in Annex I(C) or examined in accordance with Article 1 ofDecision 2000/764/EC shall be examined in an approved laboratory by one ofthe tests listed in Annex IV A.
Where the result of the monitoring test is inconclusive or positive, the tissues
shall immediately be subject to confirmatory examinations in an official
laboratory. The confirmatory examination shall start by a hystopathology
examination of the brainstem as laid down in the Manual of standards fordiagnostic tests and vaccines of the World Organisation for Animal Health(Office International des Epizooties), latest edition, except where the material isautolysed or otherwise not suitable for examination by histopathology. Wherethe result of the histopathology examination is inconclusive or negative or
where the material is autolysed, the tissues shall be subjected to an examination
by one of the other diagnostic methods mentioned in point 2.1, however, themethod must not be the same as the method used in the monitoring test.
3. Interpretation of results
An animal examined as referred to in point 2.1 shall be regarded a positive BSE
case, if the result of one of the tests is positive.
An animal examined as referred to in point 2.2 shall be regarded as a positive
BSE case if the result of the monitoring test is positive or inconclusive, and
— the result of the subsequent histopathology examination is positive, or
— the result of another diagnostic method mentioned in point 2.1. is positive.
4. Reporting of results
All positive BSE cases shall immediately be reported to the competent
authority. The competent authority shall notify positive BSE cases in
accordance with Directive 82/894/EEC (
1).!M3
(1) OJ L 378, 31.12.1982, p. 58.1998D0272 — EN — 01.01.2001 — 001.002 — 11
ANNEX IV A
1. Immunoblotting test based on a western blotting procedure for the detection of
the protease-resistant fragment PrPRes(prionics check test).
2. Chemiluminiscent ELISA involving an extraction procedure and an ELISA
technique, using an enhanced chemiluminiscent reagent (Enfer test).
3. Sandwich immunoassay for PrPRescarried out following denaturation and
concentration steps (Bio-Rad).!M31998D0272 — EN — 01.01.2001 — 001.002 — 12
ANNEX V
NATIONAL REFERENCE LABORATORIES
The national reference laboratories are:
Austria: Bundesanstalt für Tierseuchenbekämpfung, Mödling
Robert-Koch-Gasse 17A-2340 Mödling
Belgium: CERV A-CODA-V AR
Centre d’étude et de recherches vétérinaires et agrochimiques
Centrum voor Onderzoek in Diergeneeskunde en Agrochemie
Veterinary and Agrochemical Research CentreGroeselenberg 99B-1180 Bruxelles
Denmark: Statens Veterinære Serumlaboratorium
Bülowsvej 27
DK-1790 København V
Finland: Eläinlääkintä- ja elintarvikelaitos
Hämeentie 57FIN-00550 Helsinki
France: Agence française de sécurité sanitaire des aliments
Laboratoire de pathologie bovine31, avenue Tony Garnier
BP 7033
F-69342 Lyon Cédex
Germany: Bundesforschungsanstalt für Viruskrankheiten der Tiere
Anstaltsteil TübingenPostfach 1149
D-72001 Tübingen
Greece: 1. Department of Pathology, Faculty of Veterinary Medicine
University of ThessalonikiGiannitson & Voutyra St.GR-54627 Thessaloniki
2. Athens Centre of Veterinary Institutes
Laboratory of Pathology
25 Neapoleos St.GR-14310 Athens
Ireland: The Central Veterinary Research Laboratory
Abbotstown
Castleknock
Dublin 15Ireland
Italy: Istituto Zooprofilattico Sperimentale del Piemonte, Liguria e
Valle D’Aosta
CEAVia Bologna
I-148-10150 Torino
Luxembourg: CERV A-CODA-V AR
Centre d’étude et de recherches vétérinaires et agrochimiques
Centrum voor Onderzoek in Diergeneeskunde en AgrochemieVeterinary and Agrochemical Research Centre
Groeselenberg 99
B-1180 Bruxelles
Netherlands: Instituut voor Dierhouderij en Diergezondheid, ID-Lelystad
Edelhertweg 15Postbus 658200 AB Lelystad
Nederland!
M11998D0272 — EN — 01.01.2001 — 001.002 — 13
Portugal: Laboratório Nacional de Investigação Veterinária
Estrada de Benfica, 701
P-1500 Lisboa
Spain: Veterinary School Laboratory
Animal Pathology Department
Pathological AnatomyE-Zaragoza
"
M3Laboratorio Central de Veterinaria de Algete
MadridSpain(only BSE tests as referred to in Annex IV A) 3
Sweden: The National Veterinary Institute
S-751 89 Uppsala
United Kingdom: The Veterinary Laboratories Agency
Woodham LaneNew Haw
Addlestone
Surrey KT15 3NBUnited Kingdom!
M11998D0272 — EN — 01.01.2001 — 001.002 — 14