98/477/EC: Commission Recommendation of 22 July 1998 concerning information necessary to support applications for the evaluation of the epidemiological status of countries with respect to transmissible spongiform encephalopathies (notified under document number C(1998) 2268) (Text with EEA relevance)
Date: 1998-07-22
Institutions: European Commission
Subjects: animal disease, cattle, consumer protection, epidemiology, exchange of information, public health

L 212/58

‹

EN

‹

Official Journal of the European Communities

30. 7. 98

COMMISSION RECOMMENDATION

of 22 July 1998

concerning information necessary to support applications for the evaluation of
the epidemiological status of countries with respect to transmissible spongiform
encephalopathies

(notified under document number C(1998) 2268)

(Text with EEA relevance)

(98/477/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community, and in particular Article 155 thereof,

of

1. Whereas new information has been published in the
United Kingdom further supporting the hypothesis
that exposure to the bovine spongiform encephalo-
pathy (BSE) agent
is linked to the new variant of
Creutzfeldt Jacob disease in humans; whereas on 16
September 1997 the Spongiform Encephalopathy
Advisory Committee
the United Kingdom
concluded that recent research provided compelling
new evidence that the agent which causes BSE is iden-
tical to the agent which causes the new variant of CJD
in humans; whereas on 18 September 1997 the Advis-
ory Committee on Dangerous Pathogens concluded
the BSE agent should now be classified as a
that
human pathogen; whereas on 26 November 1997 the
Commission adopted Directive 97/65/EC which classi-
fied the BSE and other animal TSE agents in the same
group of risk as the human pathogen causing CJD;

2. Whereas the Council on 31 March 1998 invited the
Commission to submit an appropriate proposal in the
field of specified risk material after the conclusions of
the World Organisation for Animal Health (OIE)
session in May 1998; whereas the Commission recon-
firmed its intention to elaborate a wider Community
proposal on the basis of Article 100A, involving both
the Council and the European Parliament; whereas
Chapter 3.2.13 of the OIE code on BSE recommends
to take account of the epidemiological status when
importing from a country or a zone;

3. Whereas a risk assessment based on accepted scientific
methodology may show that there is a significantly
higher risk of exposure of animals or humans to trans-
missible spongiform encephalopathies (TSEs) in certain
countries; whereas a thorough epidemiological evalua-
tion conducted to common standards
through a
Community procedure will give the necessary informa-
tion about the status of each country;

4. Whereas the Scientific Steering Committee (SSC), in its
opinion of 23 January 1998, has established the list of
factors determining the geographical risk in a given

geographical zone; whereas the SSC, in its opinion of
19 and 20 February 1998, has established the contents
of a complete dossier of epidemiological status with
respect to TSEs;

5. Whereas the task of countries in preparing an applica-
tion for recognition of the epidemiological status of
countries with respect to TSEs will be facilitated when
information is presented according to the above scient-
ific opinion; whereas
those ap-
plications will be facilitated when such data are
presented according to the above scientific opinion;

the evaluation of

6. Whereas

the Commission will base its approach
concerning the epidemiological status on the opinion
of the SSC; whereas, therefore, the Commission en-
courages countries to submit a dossier according to this
recommendation,

HEREBY RECOMMENDS THAT:

1. Member States are invited to submit as

soon as
possible, and preferably before 1 October 1998, an
application for recognition of
their epidemiological
status with respect to TSEs, in at least one of the offi-
cial languages of the Community.

2. Member States should ensure that supporting docum-
ents accompanying the application are prepared and
presented in accordance with the recommendations set
out in the Annex.

3. All the applications and requests for additional

in-

formation should be addressed to:

for Consumer

Policy

and

European Commission
Directorate-General
Consumer Health Protection
DG XXIV/B.1,
Rue de la Loi/Wetstraat 200,
B-1049 Brussels.
Tel.
e-mail: tse-status dg24.cec.be

(32-2)295 39 62, fax (32-2)299 63 01,

30. 7. 98

‹

EN

‹

Official Journal of the European Communities

L 212/59

4. The possibilities foreseen by this recommendation shall also be open to non-member

countries.

5. The Commission services will ensure evaluation of the dossiers and will ask the Scient-

ific Steering Committee to give an opinion on all applications.

For the Commission

Franz FISCHLER

Member of the Commission

L 212/60

‹

EN

‹

Official Journal of the European Communities

30. 7. 98

ANNEX

Information to be submitted in support of an application for recognition of epidemiological
status

All data must be provided on an annual basis and preferably from 1980 onwards, but at least from 1988.

Applicant States must make every effort to provide comprehensive and consistent information. Data, which
are not provided or are regarded as incomplete or as unsatisfactory, may have to be replaced by worst-case
assumption for the purposes of a risk assessment.

Information must be provided on

1. Structure and dynamics of the bovine, ovine and caprine animal populations

(a) absolute numbers of animals per species and breed, alive and at time of slaughter;

(b) age distributions of animals per species and breed, sex and type;

(c) age distribution of animals per species and breed, sex and type at time of slaughter;

(d) geographical distribution of the animals by species and breeds;

(e) geographical distribution of the animals by husbandry systems, herd sizes and production purposes;

(f) system of identification and capacities for tracing of animals.

2. Animal trade

(a)

imports and exports;

(b) trade within the geographical area;

(c)

imports of embryos and semen;

(d) use made of imported animals, embryos or semen;

(e) mechanisms used by slaughterhouses to identify animals and their origins, as well as data from these

procedures.

3. Animal feed

(a) domestic production of meat and bone meal (MBM), and its use per species and husbandry system (in
particular the proportion of the domestically produced MBM fed to bovine, ovine and caprine
animals);

(b) imports of MBM, specifying country of origin, and its use per species and husbandry system (in par-

ticular the proportion of that MBM fed to bovine, ovine and caprine animals);

(c) exported MBM, specifying country of destination.

4. Meat and bone meal (MBM) bans

(a) complete description;

(b) dates of introduction;

(c) actual implementation, policing and compliance figures;

(d) possibilities of cross-contamination with other feed.

5. Specified bovine offal (SBO) and specified risk materials (SRM) bans

(a) complete description;

(b) dates of introduction;

(c) actual implementation, policing and compliance figures.

30. 7. 98

‹

EN

‹

Official Journal of the European Communities

L 212/61

6. Surveillance of TSE, with particular reference to BSE and scrapie

(a)

incidence of laboratory confirmed cases of BSE and scrapie;

(b) age distribution, geographical distribution, and countries of origin of cases;

(c)

incidence of neurological disorders in which TSE could not be excluded on clinical grounds in any
animal species;

(d) methodologies and programmes of surveillance and recording of clinical cases of BSE and scrapie,

including awareness training for farmers, veterinarians, supervisory bodies and authorities;

(e)

incentives for reporting cases, compensation and reward schemes;

(f) methodologies of laboratory confirmation and recording of suspect cases of BSE and scrapie;

(g) strains of BSE and scrapie agents possibly involved;

(h) existing systems or current plans for targeted active surveillance.

7. Rendering and feed processing

(a) all rendering and feed processing systems used;

(b) nature of the records of rendering and processing plants;

(c) quantitative and qualitative parameters of MBM and tallow production by each of the processing

systems;

(d) the geographical areas from which the rendered materials originate;

(e) the type of raw material used;

(f) parameters on separate processing lines for materials from healthy and suspected animals;

(g) transport and storage systems for MBM or feed containing MBM.

8. BSE or scrapie related culling

(a) culling criteria;

(b) date of introduction of the culling scheme and of any subsequent modification;

(c) animals culled (details as specified in point 1);

(d) sizes of herds in which animals were culled.