Amended proposal for a Regulation of the European Parliament and of the Council for the prevention and control of certain transmissible spongiform encephalopathies (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)
Date: 2000-12-12
Institutions: European Commission
Subjects: animal disease, consumer protection, disease prevention, health policy, infectious disease

24.4.2001

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Official Journal of the European Communities

C 120 E/89

Amended proposal for a Regulation of the European Parliament and of the Council for the
prevention and control of certain transmissible spongiform encephalopathies (1)

(2001/C 120 E/07)

(Text with EEA relevance)

COM(2000) 824 final (cid:151) 1998/0323(COD)

(Submitted by the Commission pursuant to Article 250(2) of the EC Treaty on 12 December 2000)

(1) OJ C 45, 19.2.1999, p. 2.

INITIAL PROPOSAL

AMENDED PROPOSAL

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Unchanged

Having regard to the Treaty establishing the European
Community, and in particular Article 100a (1) thereof,

Having regard to the Treaty establishing the European
Community, and in particular Article 152(4)(b) thereof,

Having regard to the proposal from the Commission,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of
Committee,

the Economic and Social

Having regard to the opinion of
Committee (2),

the Economic and Social

Acting in accordance with the procedure laid down in Article
189b of the Treaty,

Acting in accordance with the procedure laid down in Article
251 of the Treaty,

Whereas:

(1) Several distinct transmissible spongiform encephalopathies
(TSEs) have been recognised for many years to occur
separately in humans and animals. Bovine spongiform
recognised in bovine
encephalopathy (BSE) was
animals in 1986 and in following years was recognised
to occur in other species of animals. A new variant of
Creutzfeldt-Jakob Disease (nv-CJD) was described in 1996.
Evidence is accumulating that the agent causing BSE is
identical to that causing nv-CJD.

first

(1) Several distinct transmissible spongiform encephalopathies
(TSEs) have been recognised for many years to occur
separately in humans and animals. Bovine spongiform
recognised in bovine
encephalopathy (BSE) was
animals in 1986 and in following years was recognised
to occur in other species of animals. A new variant of
Creutzfeldt-Jakob Disease (v-CJD) was described in 1996.
Evidence is accumulating that the agent causing BSE is
identical to that causing v-CJD.

first

(2) Since 1990 the Community has adopted a series of
measures to protect human and animal health from the
risk of BSE. Those measures have been based on the
safeguard provisions of Council Directives on veterinary
control measures.
the
the risk posed to human and animal
magnitude of
to adopt specific rules in the
health by certain TSEs,
form of a Regulation for their prevention and control.

is appropriate,

in view of

It

Unchanged

___________
(1) At the moment at which the Amsterdam Treaty comes into force,

please read Article 152.

___________
(1) OJ C 45, 19.2.1999, p. 2.
(2) OJ C 258, 10.9.1999, p. 19.

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INITIAL PROPOSAL

AMENDED PROPOSAL

to the functioning of

(3) This regulation directly concerns public health and is
relevant
It
covers products which are included in Annex II to the
Treaty as well as products which are not. Therefore, it is
appropriate to choose Article 100a of the Treaty as the
legal basis.

the internal market.

to the functioning of

(3) This regulation directly concerns public health and is
relevant
It
covers products which are included in Annex II to the
Treaty as well as products which are not. Therefore, it is
appropriate to choose Article 152(4)(b) of the Treaty as
the legal basis.

the internal market.

(4) The Commission has obtained scientific opinions,

in
particular from the Scientific Steering Committee and
the Scientific Committee on Veterinary Measures related
to Public Health, on several aspects of TSEs. Those
opinions
to reduce the
potential risk for humans and animals resulting from
exposure to infected animal products.

include advice on measures

Unchanged

for which other

(5) The rules should apply to the production and placing on
the market of live animals and products of animal origin.
However, they should not apply to cosmetic, or medicinal
products, medical devices or their starting materials or
intermediate products,
specific rules
apply. They should also not apply to products of animal
origin which do not pose a risk to animal or human
health since they are intended for purposes other than
human food, animal feed or fertiliser. It is appropriate
to ensure that products of animal origin excluded from
the scope of this Regulation are kept separate from those
covered by it unless they meet at least the same health
standards as the latter.

(6) Provision should be made for safeguard measures to be
taken by the Commission in cases where a risk from a
TSE has not been adequately addressed by the competent
authority of a Member State or third country.

the epidemiological status, with respect

(7) A procedure should be established for the determination
of
to BSE, of
countries or regions, on the basis of the assessment of
the incident, propagation and human exposure risk using
information supplied to the Commission. Member States
and third countries which choose not to apply for their
status to be determined should be placed in a category by
the Commission on the basis of all information available
to the Commission.

(8) Member States should institute education programmes for
those involved in the prevention and control of TSEs, as
well as for veterinarians, farmers and workers involved in
the transportation, marketing and slaughter of
farm
animals.

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INITIAL PROPOSAL

AMENDED PROPOSAL

(9) Member States should carry out an annual programme of
monitoring for BSE and scrapie and should inform the
Commission and the other Member States of the results
of the programme each year, and of the emergence of any
other TSE.

animal

residence of

(10) Certain ruminant tissues should be designated as specified
risk materials on the basis of the pathogenesis of TSEs and
the epidemiological status of the country or region of
origin or
concerned. The
the
specified risk materials should be removed and disposed
of in a manner which avoids any risk to human or animal
health. In particular, they should not be placed on the
market
fertiliser.
However, provision should be made for an equivalent
level of health protection to be achieved by means of a
test for TSEs carried out on individual animals. Slaughter
techniques presenting a risk of causing brain material to
contaminate other tissues should not be permitted in
than those presenting the
countries or
lowest risk of BSE.

for human food,

regions other

feed or

animal

animal

residence of

(10) Certain ruminant tissues should be designated as specified
risk materials on the basis of the pathogenesis of TSEs and
the epidemiological status of the country or region of
origin or
concerned. The
the
specified risk materials should be removed and disposed
of in a manner which avoids any risk to human or animal
health. In particular, they should not be placed on the
market
fertiliser.
However, provision should be made for an equivalent
level of health protection to be achieved by means of a
test for TSEs carried out on individual animals, once fully
techniques presenting a risk of
validated. Slaughter
causing brain material
tissues
should not be permitted in countries or regions other
than those presenting no BSE risk.

to contaminate other

for human food,

feed or

animal

(11) Measures should be taken to prevent the transmission of
TSEs to humans or animals by prohibiting the feeding of
certain categories of animal protein to certain categories
of animals, and by prohibiting the use of certain ruminant
materials in human food. Those prohibitions should be
proportionate to the risks involved.

Unchanged

(12) The suspected presence of any TSE in any animal should
be notified to the competent authority, which should
immediately take all appropriate measures,
including
placing the suspect animal under movement restrictions
pending the outcome of an assessment or its killing under
the competent authority cannot
official supervision.
exclude the possibility of a TSE, it should have the appro-
priate investigations carried out and should retain the
carcass under official supervision until a diagnosis has
been made.

If

(13) In the event of official confirmation of the presence of a
TSE, the competent authority should take all the necessary
measures including the destruction of the carcass, carrying
out an enquiry to identify any other animals at risk, and
placing animals and products of animal origin identified
as carrying a risk under movement restrictions. Owners
should be compensated fully, without delay, for the loss of
animals and products of animal origin destroyed pursuant
to this Regulation.

(14) Member States should draw up contingency plans for the
national measures to be implemented in the event of an
outbreak of BSE. Those plans should be approved by the
Commission. Provision should be made for extending this
provision to TSEs other than BSE.

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INITIAL PROPOSAL

AMENDED PROPOSAL

(15) Provisions should be laid down covering the placing on
the market of certain live animals,
semen, ova and
embryos. Existing Community rules on the identification
and registration of bovine animals provide for a system
enabling the animals to be traced back to the dam and
herd of origin in accordance with the international
standards. Equivalent guarantees should be provided for
imported from third countries. The
bovine animals
animals and products of animal origin covered by these
provisions, moving in intra-Community trade or imported
from third countries, should be accompanied by the
certificates required by Community legislation, supple-
mented as appropriate in accordance with this Regulation.
Those existing rules may be extended to cover other live
animals, semen, ova and embryos.

(16) The placing on the market of products of animal origin
derived from bovine animals in high risk areas should be
prohibited. However, that prohibition should not apply to
certain products of
animal origin produced under
controlled conditions from animals which can be demon-
strated not to pose a high risk of infection with a TSE.

in order

is necessary,

to ensure that

It
the rules
concerning the prevention and control of TSEs are
observed, for samples to be taken for laboratory testing.
In order to guarantee uniform testing procedures and
results, national and Community Reference Laboratories
should be established.

(17) It

in order

is necessary,

to ensure that

the rules
concerning the prevention and control of TSEs are
observed, for samples to be taken for laboratory testing
on the basis of an established protocol designed to
produce a complete epidemiological picture of TSEs. In
order to guarantee uniform testing procedures and results,
national and Community Reference Laboratories and
including rapid diagnostic
reliable scientific methods,
tests for TSEs, should be established. Rapid diagnostic
tests should be used as far as possible.

Unchanged

(18) Community inspections should be carried out

in the
Member States in order to ensure uniform implementation
the requirements concerning the prevention and
of
control of TSEs and should also include the application
of audit procedures. In order to ensure that guarantees
concerning the prevention and control of TSEs equivalent
to those applied by the Community are provided by third
live animals and products of
countries on import of
animal origin, Community on the spot inspections and
audits must be carried out in order to verify that the
import conditions are met by exporting third countries.

(19) Trade measures for TSEs should be based on international
standards, guidelines or recommendations, where they
exist. However, scientifically justified measures resulting
in a higher level of sanitary protection may be adopted
if measures based on the relevant international standards,
guidelines or recommendations would not achieve the
appropriate level of sanitary protection.

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INITIAL PROPOSAL

AMENDED PROPOSAL

(20) This Regulation should be reviewed in the light of new

scientific information.

(21) It is appropriate to provide for the transitional measures
necessary for regulating the use of specified risk material
within the context of this Regulation.

(20) The Commission should be entrusted with the task of
adopting certain measures for implementing this Regu-
lation. To that end, procedures should be laid down estab-
lishing close and effective co-operation between the
Commission and the Member States within the Standing
Veterinary Committee and the Standing Committee for
Feedingstuffs.

(22) The Commission should be entrusted with the task of
adopting certain measures for implementing this Regu-
lation. To that end, procedures should be laid down estab-
lishing close and effective co-operation between the
Commission and the Member States within the Standing
Veterinary Committee, the Standing Committee for Feed-
ingstuffs and the Standing Committee for Foodstuffs.

(23) Since the measures necessary for the implementation of
this Regulation are measures of general scope within the
meaning of Article 2 of Council Decision 1999/468/EC of
28 June 1999 (1)
laying down the procedures for the
exercise of
conferred on the
Commission, they should be adopted by use of the regu-
latory procedure provided for
that
Decision,

implementing powers

in Article 5 of

(21) This Regulation should be reviewed in the light of new

Deleted

scientific information

HAVE ADOPTED THIS REGULATION:

Unchanged

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

This Regulation lays down rules for

the prevention,
1.
control and eradication of certain transmissible spongiform
encephalopathies (TSEs). It shall apply to the production and
placing on the market of live animals and products of animal
origin.

2.

This Regulation shall not apply to:

(a) cosmetic or medicinal products or medical devices, together
with their starting materials or intermediate products;

(b) products which are not destined for use in human food,
starting

together with their

feed or

animal
materials or intermediate products;

fertilisers

___________
(1) OJ L 184, 17.7.1999, p. 23.

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INITIAL PROPOSAL

AMENDED PROPOSAL

(c) products of animal origin destined for exhibition, teaching,

research, special studies or analysis.

(d) live animals, embryos, ova and sperm used in and destined

for research.

Article 2

Unchanged

Separation of products of animal origin

In order to avoid cross-contamination or substitution of the
products of animal origin referred to in Article 1(1) by those
referred to in Article 1(2), they shall be kept separate at all
stages unless the latter are produced under at least the same
conditions of health protection in respect of TSEs.

In order to avoid cross-contamination or substitution of the
products of animal origin referred to in Article 1(1) by those
referred to in Article 1(2)(a), (b) and (c) or by the live animals,
embryos, ova and sperm as referred to in Article 1(2)(d), they
shall be kept separate at all stages unless the latter are
produced under at
the same conditions of health
protection in respect of TSEs.

least

Rules for the implementation of this Article shall be adopted in
accordance with the procedure laid down in Article 22.

Rules for the implementation of this Article shall be adopted in
accordance with the procedure referred to in Article 22(2).

Article 3

Definitions

Unchanged

For the purposes of this Regulation, the following definitions
and those laid down in Annex I shall apply:

1. transmissible spongiform encephalopathies or TSEs: all TSEs

with the exception of those occurring in humans;

2. placing on the market: any operation the purpose of which is
to supply live animals, semen, embryos, ova or products of
animal origin covered by this Regulation to a third party
for sale, or any other form of transfer against payment or
free of charge to a third party and storage with a view to
supply to a third party, regardless of whether the operation
takes place within a Member State, between Member States
or between a Member State and a third country or vice
versa;

3. products of animal origin: any products derived from or

containing a product derived from any animal;

4. starting materials: raw materials or any other product of
animal origin out of which, or with the help of which,
the products referred to in Article 1(2)(a) and (b) are
produced;

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INITIAL PROPOSAL

AMENDED PROPOSAL

5. competent authority: the central authority of a Member State
competent to ensure compliance with the requirements of
this Regulation or any authority to which that central
authority has delegated that competence;
it shall also
include, where appropriate, the corresponding authority
of a third country;

6. categories: the categories set out in Annex II, Chapter B;

7. specified risk material: the tissues specified in Annex IV;
it does not include products

unless otherwise specified,
containing or derived from those tissues;

8. farmed animal: any vertebrate or invertebrate animal which
is kept,
the
production of meat, milk, eggs, wool, fur, feathers, skins,
or any other product of animal origin;

fattened or bred for

reproduction or

9. skull: the bones of the head, including the bones of the

lower jaw;

10. animals

suspected of being infected: animals which show
clinical signs compatible with TSE and for which no alter-
native diagnosis has been established, or animals showing
post-mortem lesions or reactions in laboratory tests giving
rise to reasonable suspicion of the presence of a TSE. BSE
shall be suspected in bovine animals aged over 20 months
and scrapie in ovine and caprine animals aged over 12
signs
months displaying behavioural or neurological
where the disease cannot be ruled out either on the
basis of response to treatment or following laboratory
examination;

10. animals suspected of being infected: live, slaughtered or dead
animals which show or have shown neurological and
behavioural disorders or a progressive deterioration in
their general condition linked to an impairment of the
central nervous system and for which the information
gathered on the basis of clinical examination, response to
treatment, a post-mortem examination or an ante- or post-
mortem laboratory analysis does not allow a different
diagnosis to be established.

BSE shall be suspected in bovine animals for which the
cause of death is unknown or which undergo emergency
slaughter and which have produced a positive result from a
rapid diagnostic test evaluated and approved by the
Commission;

11. holding: any place in which animals covered by this Regu-
lation are held, kept, bred, handled or shown to the public;

Unchanged

12. sampling:

the taking of samples, ensuring a statistically
correct representation, from animals or their environment,
or from products of animal origin,
for the purpose of
establishing a disease diagnosis, for health surveillance, or
for
the absence of microbiological
agents or certain materials in products of animal origin;

the monitoring of

13. Rapid diagnostic tests: tests that produce results within 24
hours and which are referred to in Annex X, Chapter C.

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INITIAL PROPOSAL

AMENDED PROPOSAL

Article 4

Safeguard measures

Unchanged

1. Where the risk of transmission of a spongiform encepha-
lopathy constitutes a hazard to the life or health of humans or
animals in the Community and the competent authority has
not
the Commission shall,
acting on its own initiative or at the request of a Member
State, adopt the appropriate safeguard measures without delay.

taken the appropriate measures,

Where a Member State has requested such measures the
Commission shall decide on that request within ten working
days after receipt thereof.

2. Within ten working days after
the
safeguard measures, the Commission shall confirm, amend or
repeal
in accordance with the procedure laid down in
Article 22.

the adoption of

the
2. Within ten working days after
safeguard measures,
they shall be confirmed, amended or
repealed by a decision adopted in accordance with the
procedure referred to in Article 22(2).

the adoption of

That decision, with a statement of reasons, shall at the same
time be notified to the European Parliament.

CHAPTER II

Unchanged

DETERMINATION OF BSE STATUS

Article 5

Classification

1.
The BSE status of a Member State or a third country, or
of a region thereof, can only be determined on the basis of the
criteria set out in Annex II, Chapter A and the outcome of a
risk analysis on the basis of all the potential factors for the
appearance of bovine spongiform encephalopathy and their
development over time, set out in Annex II, Chapter A.

Member States or third countries shall submit an application to
the Commission, accompanied by the information laid down in
Annex II, Chapter A, for their BSE status to be determined.

Member States or third countries shall submit an application to
the Commission, accompanied by the relevant
information
with respect to the criteria laid down in Annex II, Chapter
A, and the potential risk factors laid down in Annex II
Chapter A for their BSE status to be determined.

acting

The Commission,

2.
in accordance with the
procedure laid down in Article 23 shall take a decision in
respect of each application to place the applicant Member
State or
the
categories
in Annex II, Chapter and taking into
account the criteria and potential risk factors laid down in
paragraph 1.

third country, or
set out

region thereof,

in one of

2.
A decision in respect of each application to place the
applicant Member State or third country, or region thereof,
in one of the categories set out in Annex II, Chapter B, shall
be adopted taking into account the criteria and potential risk
factors referred to in paragraph 1 in accordance with the
procedure referred to in Article 22(2).

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INITIAL PROPOSAL

AMENDED PROPOSAL

The Commission shall take its decision within six months after
the submission of the application. If the Commission finds that
the application does not include all the information laid down
in Annex II, Chapter A, it shall ask for additional information
within a delay to be specified. The final decision shall then be
taken within six months after submission of
the complete
information.

the application and the relevant

the
The decision shall be taken within six months after
submission of
information
referred to in paragraph 1. If the Commission finds that the
include the information laid down in
application does not
Annex II, Chapter A,
information
it shall ask for additional
within a delay to be specified. The final decision shall then
be taken within six months after submission of the complete
information.

After the World Organisation for Animal Health (International
Office of Epizootics (cid:151) IOE/OIE) has established a procedure
for the classification of countries into categories and if it has
placed the applicant country in one of these categories, the
Commission may, in compliance with the first subparagraph
and if appropriate, propose a review to the Community
categorisation of the country concerned in accordance with
the procedure referred to in Article 22(2).

3.
If the Commission finds that the information submitted
by Member States or third countries pursuant to Annex II,
it may determine the
Chapter A,
BSE status of the Member State or third country concerned
on the basis of a full risk analysis.

is insufficient or unclear,

rapid diagnostic

Such a risk analysis must include a conclusive statistical survey
of the epidemiological situation regarding TSEs in the Member
State or third country, on the basis of the use, in a screening
the
procedure, of
Commission. The Commission shall
the
classification criteria used by the International Office of
Epizootics. The rapid diagnostic tests shall be approved for
that purpose in accordance with the procedure referred to in
Article 22(2), and shall be listed in Annex X, Chapter C,
paragraph 3.

evaluated by
take into account

tests

Member States or

3.
third countries which have not
submitted an application in accordance with paragraph 1
within six months after the date referred to in the second
paragraph of Article 26 shall be placed in a category by the
Commission on the basis of all
information available to the
Commission.

4. Member States shall communicate any changes in the
circumstances relevant to their BSE status to the Commission
without delay. The eligibility of third countries to export to the
for
Community live animals or products of animal origin,
which this Regulation provides specific rules, shall be condi-
tional upon their undertaking in writing to communicate any
changes in the circumstances relevant to their BSE status to the
Commission without delay.

Such laboratory analyses may also be requested by Member
States or third countries which wish to be assigned by the
Commission to a category defined in Annex II, Chapter B,
other than that originally determined.

The cost of such laboratory analyses shall be borne by the
Member State or third country concerned.

4. Member States or
third countries which have not
submitted an application in accordance with paragraph 1
within six months after the date referred to in the second
to the dispatch
paragraph of Article 25 shall with respect
live animals and products of animal
from their territory of
origin, be treated until
they do so as countries placed in
Category 4.

5. Member States shall communicate any changes in the
circumstances relevant to their BSE status to the Commission
without delay,
the monitoring
in particular the results of
programmes provided for in Article 7. The eligibility of third
countries to export to the Community live animals or products
of animal origin, for which this Regulation provides specific
rules, shall be conditional upon their undertaking in writing to
communicate any changes in the circumstances relevant
to
their BSE status to the Commission without delay.

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INITIAL PROPOSAL

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5.
The decisions referred to in paragraphs 2, 3 and shall be
taken after consultation of the appropriate scientific committee
and shall be based on an assessment of the incident, propa-
gation and human exposure risk, taking into consideration the
recommended criteria (1) set out in Annex II, Chapter B.

6.
The decisions referred to in paragraphs 2, 3 and 4 shall
be based on an assessment of the incident, propagation and
human exposure risk, taking into consideration the recom-
mended criteria (1) set out in Annex II, Chapter B.

CHAPTER III

Unchanged

PREVENTION OF TSES

Article 6

Education programme

Member States shall establish education programmes for staff
of the competent authority and of diagnostic laboratories, for
veterinarians, farmers and workers involved in transportation,
marketing and slaughter of farmed animals, animal breeders
and keepers and persons handling animals
to
enhance the efficacy of the monitoring system, referred to in
Article 7, and to encourage reporting of cases of neurological
disease in adult animals and, as appropriate, laboratory findings
relating to TSEs.

in order

Article 7

Monitoring system

1.
Each Member State shall carry out an annual programme
of monitoring of BSE and scrapie in accordance with Annex III,
Chapter A.

2.
Each Member State shall inform the Commission and the
other Member
Standing Veterinary
the results obtained from the monitoring
Committee, of
programme referred to in paragraph 1, and of the emergence
of TSEs other than BSE or scrapie.

States, within

the

1.
Each Member State shall carry out an annual programme
of monitoring of BSE and scrapie in accordance with Annex III,
Chapter A. That programme
screening
procedure using the rapid diagnostic tests evaluated by the
Commission.

include

shall

a

The rapid diagnostic tests shall be approved for that purpose in
accordance with the procedure referred to in Article 22(2), and
shall be listed in Annex X, Chapter C, paragraph 3.

Unchanged

3.
The information for each calendar year shall be presented
in a report submitted to the Commission at the latest by 31
March of
the
information referred to in Annex III, Chapter B.

the following year.

shall cover at

least

It

___________
(1) The Commission undertakes to propose during the legislative
the propagation and
the assessment of

process, criteria for
human exposure risk.

___________
(1) The Commission undertakes to propose during the legislative
the propagation and
the assessment of

process, criteria for
human exposure risk.

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Article 8

Specified risk material

The specified risk materials

1.
shall be removed and
disposed of in accordance with Annex IV. They shall not be
placed on the market for human food, animal feed or fertilisers.

AMENDED PROPOSAL

Paragraph 1 shall not apply where animals have been
2.
subjected to a
test which has been approved by the
Commission in accordance with the procedure laid down in
Article 22, applied under the conditions laid down in Annex
IV, point 7, and the results of that test were negative.

2.
Paragraph 1 shall not apply where animals have been
subjected to a test which has been approved for that distinct
purpose in accordance with the procedure referred to in Article
22(2), and listed in Annex X, Chapter C, paragraph [. . .],
applied under the conditions laid down in Annex IV, point 7,
and the results of that test were negative.

3.
In Member States, or regions thereof, which are not
placed in Category 1, the following slaughter techniques shall
not be used on bovine, ovine or caprine animals whose meat is
destined for human or animal consumption:

Unchanged

(a) stunning or killing by means of a gas injected into the

cranial cavity;

(b) laceration after stunning of central nervous tissue by means
of an elongated rod-shaped instrument introduced into the
cranial cavity.

4.
The data relating to age set out in Annex IV shall be
adjusted regularly. Such adjustments shall be based on the
latest proven scientific findings concerning the statistical prob-
the
the occurrence of a TSE in the cohorts of
ability of
Community’s cattle, sheep and goat population concerned.

5.
By way of derogation from paragraphs 1 to 4 a decision
may be taken in accordance with the procedure referred to in
Article 22(2), in respect of the date of effective enforcement of
the provisions of Article 9(1), or
the
as
feeding of mammalian protein to
prohibition on the
ruminants
region thereof placed in
Category 2 or 3, to allow the provisions of this Article to be
confined to animals which were born before that date in those
countries or regions.

in each country or

appropriate,

Also by way of derogation from paragraphs 1 to 4, after
consultation of the appropriate scientific committee and on
the basis of an assessment of the incident, propagation and
human exposure risk, a decision may be taken in accordance
with the procedure referred to in Article 22(2) to allow the use
of vertebral column and dorsal root ganglia for food, feed and
fertilisers from animals in or coming from each country or
region thereof in Category 4.

Rules for the implementation of

4.
this Article shall be
adopted in accordance with the procedure laid down in
Article 22.

Rules for the implementation of

6.
this Article shall be
adopted in accordance with the procedure referred to in
Article 22(2).

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INITIAL PROPOSAL

Article 9

Animal feeding

AMENDED PROPOSAL

Unchanged

The feeding to ruminants of protein derived from

1.
mammals is prohibited.

In Member States, or regions thereof, which are placed in

2.
Category 4, the following are prohibited:

The prohibition referred to in paragraph 1 shall be

2.
extended in accordance with Annex V, point 1.

(a) the feeding to any farmed animal of protein derived from

Deleted

mammals; and,

(b) the feeding to any mammal of protein derived from

ruminants.

Paragraphs 1 and 2 shall apply without prejudice to the

3.
provisions of Annex V.

Paragraphs 1 and 2 shall apply without prejudice to the

3.
provisions of Annex V, point 2.

4. Member States, or regions thereof,
in Category 4 shall
not be permitted to export or store feed for farmed animals
which contains protein derived from mammals or feed for
mammals which contains protein derived from ruminants.

Third countries, or regions thereof, in Category 4 shall not be
permitted to export to the Community feed for farmed animals
which contains protein derived from mammals or feed for
mammals which contains protein derived from ruminants.

Rules for the implementation of this Article,

4.
including
rules on the prevention of cross contamination and on
sampling and methods of analysis to check compliance, shall
be adopted in accordance with the procedure laid down in
Article 22.

Rules for the implementation of this Article,

5.
including
rules on the prevention of cross contamination and on
sampling and methods of analysis to check compliance, shall
be adopted in accordance with the procedure referred to in
Article 22(2).

Article 10

Unchanged

Certain products of animal origin derived from or
containing ruminant products

1.
In Member States, or regions thereof, which are placed in
Category 4, the use of ruminant materials for the production
of the products of animal origin referred to in Annex VI shall
be subject to the conditions laid down in that Annex.

2.
In Member States, or regions thereof, which are not
placed in Category 1, the use of ruminant skull and vertebral
column for the production of mechanically separated meat is
prohibited.

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INITIAL PROPOSAL

AMENDED PROPOSAL

Rules for the implementation of this Article,

3.
including
rules on production standards, shall be adopted in accordance
with the procedure laid down in Article 22.

Rules for the implementation of this Article,

3.
including
rules on production standards, shall be adopted in accordance
with the procedure referred to in Article 22(2).

CHAPTER IV

Unchanged

CONTROL AND ERADICATION OF TSES

Article 11

Notification of suspected presence of TSEs

Without prejudice to Council Directive 82/894/EEC (1),
suspected presence of any TSE in any animal
notified immediately to the competent authority of
Member State concerned.

the
shall be
the

The competent authority shall without delay take the measures
laid down in Article 12 of this Regulation, together with any
other necessary measures.

The suspected presence of any TSE in the Member States shall
be notified to the Commission on a regular basis.

Article 12

Unchanged

Measures with respect to suspect animals

1.
Any animal suspected of being infected by a TSE shall
either be placed under official movement restrictions pending
the outcome of an assessment by the competent authority or
killed under official supervision.

infection with a TSE cannot be ruled out,

2. Where the competent authority decides that the possi-
the
bility of
suspect animal shall be killed and its brain and such other
tissues as the competent authority may determine shall be
removed and sent
the
national reference laboratory provided for in Article 17(1) or
the Community reference laboratory provided for in Article
17(2),
the presence of a TSE using the
testing for
methods referred to in Article 18.

to an officially approved laboratory,

for

3.
All parts of the body of the suspect animal, including the
hide but excluding the tissues which are being tested in
accordance with paragraph 2, shall be retained under official
supervision until a negative diagnosis has been made, or until
it has been completely destroyed in accordance with Annex IV,
point 4 or, as appropriate, point 5.

All parts of the body of the suspect animal, including the
3.
supervision until a
hide,
shall be retained under official
negative diagnosis has been made, or until
it has been
completely destroyed in accordance with Annex IV, point 4
or, as appropriate, point 5.

___________
(1) OJ L 378, 31.12.1982, p. 58.

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INITIAL PROPOSAL

AMENDED PROPOSAL

Measures following confirmation of the presence of TSEs

Article 13

Unchanged

1. Where
the presence of a TSE has been officially
confirmed, the following measures shall be applied without
delay:

(a) all parts of the body of the animal shall be completely
in accordance with Annex IV, point 4 or, as

destroyed,
appropriate, point 5;

(b) an inquiry shall be carried out to identify all animals at risk

in accordance with Annex VII, point 1.

2. Where the presence of a TSE has been officially
confirmed, all animals, semen, ova and embryos referred to
in Annex VII, point 2, that have been identified to be at risk
by the inquiry referred to in paragraph 1(b) shall be placed
under movement restriction or killed and completely destroyed
in accordance with Annex IV, point 4 or, as appropriate,
point 5.

2. Where the presence of a TSE has been officially
confirmed, all animals, semen, ova and embryos referred to
in Annex VII, point 2, that have been identified to be at risk
by the inquiry referred to in paragraph 1(b) shall be killed and
completely destroyed in accordance with Annex IV, point 4 or,
as appropriate, point 5.

A Member State may, by way of derogation from the
provisions of this paragraph, apply other measures offering
an equivalent level of protection where such measures have
been approved in accordance with the procedure referred to
in Article 22(2).

Pending the completion of the measures referred to in
3.
paragraph 1(b) and paragraph 2, the holding on which the
animal was present when the presence of a TSE was
suspected shall be placed under official surveillance and all
movement of animals susceptible to TSEs, their semen, ova
and embryos, from or to the holding shall be subject to auth-
orisation by the competent authority, with a view to ensuring
immediate tracing and identification of
their
semen, ova and embryos in question.

the animals,

Unchanged

4.
Owners shall be compensated without delay for the loss
of the animals that have been killed in accordance with Article
12(2) and paragraph 2 of this Article, or the semen, embryos
and ova that have been destroyed in accordance with
paragraphs 1 and 2 of this Article. The compensation shall
not be less than 100 % of the market value.

The provisions of paragraph 2 shall be amended in

5.
accordance with the procedure laid down in Article 23.

5. Without prejudice to Directive 82/894/EEC the confirmed
presence of any TSE other than BSE shall be notified to the
Commission on a monthly basis.

Rules for the implementation of

6.
this Article shall be
adopted in accordance with the procedure laid down in
Article 22.

Rules for the implementation of

6.
this Article shall be
adopted in accordance with the procedure referred to in
Article 22(2).

24.4.2001

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Official Journal of the European Communities

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INITIAL PROPOSAL

Article 14

Contingency plan

AMENDED PROPOSAL

Unchanged

1.
A contingency plan specifying the national measures to
be implemented in the event of an occurrence of BSE shall be
drawn up by each Member State in accordance with the general
criteria laid down in Community rules on the control of animal
diseases.

This plan must provide for access to the personnel, facilities,
equipment and all other appropriate materials necessary for the
rapid and efficient eradication of BSE.

2.
The contingency plans referred to in paragraph 1 shall be
submitted to the Commission no later than six months after
the date referred to in the second paragraph of Article 25.

The Commission shall approve the contingency plans in

3.
accordance with the procedure laid down in Article 22.

The contingency plans shall be approved in accordance

3.
with the procedure referred to in Article 22(2).

The plans may subsequently be amended or supplemented, in
accordance with the same procedure.

Unchanged

4.
The provisions of paragraphs 1, 2 and 3 may be extended
to TSEs other than BSE in accordance with the procedure laid
down in Article 23.

4.
The provisions of paragraphs 1, 2 and 3 may be extended
to TSEs other than BSE in accordance with the procedure
referred to in Article 22(2).

Rules for the implementation of

5.
this Article shall be
adopted in accordance with the procedure laid down in
Article 22.

Rules for the implementation of

5.
this Article shall be
adopted in accordance with the procedure referred to in
Article 22(2).

CHAPTER V

Unchanged

PLACING ON THE MARKET

Article 15

Live animals, semen, embryos and ova

1.
The placing on the market of bovine, ovine or caprine
animals and their semen, embryos and ova shall be subject to
the conditions laid down in Annex VIII, Chapter A. The
animals and their semen, embryos and ova shall be accom-
panied by the appropriate animal health certificates as
required by Community legislation, subject to the conditions
laid down in Annex VIII, Chapter D.

The animals

referred to in Annex VIII, Chapter B
2.
imported from countries or regions thereof in Categories 2,
3 and 4 shall be identified by a permanent
identification
system enabling them to be traced back to the dam and herd
of origin.

3.
Placing on the market of first generation progeny, semen,
ova and embryos of TSE suspect or confirmed animals shall be
subject to the conditions laid down in Annex VIII, Chapter C.

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INITIAL PROPOSAL

AMENDED PROPOSAL

4.
The provisions of paragraphs 1, 2 and 3 may be extended
to other animals, semen, ova or embryos in accordance with
the procedure laid down in Article 23.

4.
The provisions of paragraphs 1, 2 and 3 may be extended
to other animals, semen, ova or embryos in accordance with
the procedure referred to in Article 22(2).

Rules for the implementation of

5.
this Article shall be
adopted in accordance with the procedure laid down Article 22.

Rules for the implementation of

5.
this Article shall be
adopted in accordance with the procedure referred to in
Article 22(2).

Article 16

Unchanged

Bovine, ovine or caprine meat and certain products of
animal origin thereof

1.
The following products of animal origin containing
material derived from bovine, ovine or caprine animals shall
be subject to the rules laid down in paragraphs 2 to 6 of this
Article and Annex IX.

(a)

fresh meat as defined by Council Directive 64/433/EEC (1);

(b) minced meat and meat preparations as defined by Council

Directive 94/65/EC (2);

(c) meat products and other products of animal origin as

defined by Council Directive 77/99/EEC (3);

(d) milk

products

Council Directive
92/46/EEC (4) which are destined for human consumption
and contain gelatine or rendered animal fat;

defined

by

as

(e) milk

products

Council Directive
92/118/EEC (5) which are destined for animal consumption
and contain gelatine or rendered animal fat;

defined

by

as

(f)

products

by Council Directive
defined
fishery
91/493/EEC (6) which
human
for
destined
are
consumption and contain gelatine or rendered animal fat;

as

(g) egg

Council Directive
defined
products
89/437/EEC (7) which
human
are
consumption and contain gelatine or rendered animal fat;

by
destined

for

as

(h)

snails or frogs’ legs as referred to by Directive 92/118/EEC
which are destined for human consumption and contain
gelatine or rendered animal fat;

(i)

rendered fats as referred to by Directive 92/118/EEC;

___________
(1) OJ 121, 29.7.1964, p. 2012/64.
(2) OJ L 368, 31.12.1994, p. 10.
(3) OJ L 26, 31.1.1977, p. 85.
(4) OJ L 268, 14.9.1992, p. 1.
(5) OJ L 62, 15.3.1993, p. 49.
(6) OJ L 268, 24.9.1991, p. 15.
(7) OJ L 212, 22.7.1989, p. 87.

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INITIAL PROPOSAL

AMENDED PROPOSAL

(j)

gelatine as referred to by Directive 92/118/EEC;

(k) petfood as referred to by Directive 92/118/EEC;

(l)

processed animal protein as
92/118/EEC;

referred to by Directive

(m) bones and bone products as referred to by Directive

92/118/EEC;

(n)

raw material for the manufacture of animal feedingstuffs as
referred to by Directive 92/118/EEC.

2.
Products referred to in paragraph 1 containing material
derived from bovine animals coming from countries or regions
thereof in Category 4 shall not be placed on the market.

3.
The prohibition referred to in paragraph 2 shall not apply
to the products referred to in Annex IX, Chapter A.I containing
material derived from the following bovine animals:

(a) animals born after the date from which the ban on the
feeding of ruminants with protein derived from mammals
has been effectively enforced which are eligible under a
Date-based Scheme, or, as appropriate, an equivalent
scheme, as laid down in Annex IX, Chapter A.II; or

(b) animals which were born, raised and had remained in herds
with a certified history of
freedom from BSE and are
eligible under a Certified Animal Scheme, or, as appro-
priate, an equivalent scheme, as laid down in Annex IX,
Chapter A.III.

4.
For the purpose of import into the Community, products
referred to in paragraph 1 shall be accompanied by the appro-
priate certificate, as required by Community legislation, supple-
mented in accordance with the provisions laid down in Annex
IX, Chapter B.II.

Where such products are imported from third countries or
regions thereof in Category 4, or regions within such third
countries,
they shall also comply with the conditions laid
down in Annex IX, Chapter B.I.

5.
If necessary, the provisions of paragraphs 1 to 4 may be
extended to products of animal origin other than those referred
to in paragraph 1 in accordance with the procedure laid down
in Article 23.

5.
If necessary, the provisions of paragraphs 1 to 4 may be
extended to products of animal origin other than those referred
to in paragraph 1 in accordance with the procedure referred to
in Article 22(2).

Rules for the implementation of

6.
this Article shall be
adopted in accordance with the procedure laid down in
Article 22.

Rules for the implementation of

6.
this Article shall be
adopted in accordance with the procedure referred to in
Article 22(2).

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INITIAL PROPOSAL

CHAPTER VI

AMENDED PROPOSAL

Unchanged

REFERENCE LABORATORIES, SAMPLING, TESTING AND
CONTROLS

Article 17

Reference laboratories

1.
The national reference laboratory in each Member State
and their functions and duties shall be those laid down in
Annex X, Chapter A.

The Community reference laboratory and its function and

2.
duties shall be those laid down in Annex X, Chapter B.

Article 18

Sampling and laboratory methods

1.
Sampling and laboratory testing for the presence of a TSE
shall be carried out using the methods and protocols laid down
in Annex X, Chapter C. In the absence of such methods and
protocols, those recommended in the Manual of Standards for
Diagnostic Tests and Vaccines of the International Office for
Epizootics (IOE/OIE), May 1998 edition shall apply.

2.
Rules for the implementation of paragraph 1 shall be
adopted in accordance with the procedure laid down in
Article 22.

2.
Rules for the implementation of paragraph 1 shall be
adopted in accordance with the procedure referred to in
Article 22(2).

Article 19

Community controls

Unchanged

the Member States,

The Commission shall,

in co-operation with the
1.
competent authorities of
carry out
on-the-spot inspections and audits of all levels of production
and placing on the market of animals and products of animal
origin covered by this Regulation and of the organisation and
functioning of the competent authorities in the Member States
and in third countries, in order to ensure that the provisions of
this Regulation,
thereto and any
rules adopted pursuant
safeguard measures are applied uniformly.

2.
Rules for the implementation of paragraph 1 shall be
adopted in accordance with the procedure laid down in
Article 22.

2.
Rules for the implementation of paragraph 1 shall be
adopted in accordance with the procedure referred to in
Article 22(2).

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INITIAL PROPOSAL

CHAPTER VII

AMENDED PROPOSAL

Unchanged

FINAL PROVISIONS

TRANSITIONAL AND FINAL PROVISIONS

Article 20

Transitional specified risk material measures

The provisions of Annex XI shall apply for a transitional period
which shall last no less than six months from the date referred
to in Article 25 and shall end when a decision has been taken
in accordance with paragraphs 2 or 4 of Article 5, whereupon
Article 8 shall apply.

the conclusive statistical survey carried out
The results of
pursuant to paragraph 3 of Article 5 during the transitional
the risk
period shall be used to verify the outcome of
assessment referred to in paragraph 1 of Article 5,
taking
into account the classification criteria used by the International
Office of Epizootics.

Detailed rules with respect to the conclusive statistical survey
shall be adopted in accordance with the procedure referred to
in Article 22(2) after consultation of the appropriate scientific
committee.

Article 20

Article 21

Amendments to Annexes and transitional measures

Unchanged

The Commission shall, after obtaining the opinion of
appropriate Scientific Committee on any matter
have an effect on health:

the
likely to

After consultation of the appropriate Scientific Committee on
any matter likely to have an effect on health, the Annexes shall
be amended or supplemented and any appropriate transitional
measures shall be adopted in accordance with the procedure
referred to in Article 22(2).

(a) amend or supplement the Annexes in accordance with the

Deleted

procedure laid down in Article 23.

(b) adopt any appropriate transitional measures adopt

in

accordance with the procedure laid down in Article 22.

Article 21

Committees

Article 22

Unchanged

The Commission shall be assisted by the Standing Veterinary
Committee. However, the Commission shall be assisted by the
Standing
Standing Committee
Committee
falling exclusively
within their respective competencies.

Feedingstuffs or
for matters

for
for Foodstuffs

the

Committee. However,

1.
The Commission shall be assisted by the Standing
relating
Veterinary
exclusively to feedingstuffs the Commission shall be assisted
by the Standing Committee for Feedingstuffs and for matters
relating exclusively to foodstuffs the Commission shall be
assisted by the Standing Committee for Foodstuffs.

for matters

2. Where reference is made to this paragraph, the regulatory
procedure laid down in Article 5 of Decision 1999/468/EC
shall apply, in compliance with Article 7 and Article 8 thereof.

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INITIAL PROPOSAL

AMENDED PROPOSAL

The period provided for in Article 5(6) of Decision
3.
1999/468/EC shall be three months or,
in the case of
safeguard measures adopted in accordance with Article 4(2)
of this Regulation, 15 days.

Article 22

Deleted

Management procedure

Where reference is made to the procedure laid down in this
Article, the representative of the Commission shall submit to
the committee a draft of
the measures to be taken. The
committee shall deliver its opinion on the draft within a
time limit which the Chairman may lay down according to
the urgency of the matter. The opinion shall be delivered by
the majority laid down in Article 148(2) of the Treaty in the
case of decisions which the Council is required to adopt on a
proposal from the Commission. The votes of the represen-
tatives of the Member States within the committee shall be
weighted in the manner set out in that Article. The chairman
shall not vote.

the

opinion

The Commission shall adopt measures which shall apply
immediately. However, if these measures are not in accordance
with
be
communicated by the Commission to the Council forthwith.
In that event, the Commission may defer application of the
measures which it has decided for a period of not more than
one month from the date of such communication.

committee,

shall

they

the

of

The Council, acting by a qualified majority, may take a different
decision within the time limit referred to in the previous
paragraph.

Article 23

Regulatory procedure

Where reference is made to the procedure laid down in this
Article, the representative of the Commission shall submit to
the committee a draft of
the measures to be taken. The
committee shall deliver its opinion on the draft within a
time limit which the Chairman may lay down according to
the urgency of the matter. The opinion shall be delivered by
the majority laid down in Article 148(2) of the Treaty in the
case of decisions which the Council is required to adopt on a
proposal from the Commission. The votes of the represen-
tatives of the Member States within the committee shall be
weighted in the manner set out in that Article. The chairman
shall not vote.

The Commission shall adopt the measures envisaged if they are
in accordance with the opinion of the committee.

the measures envisaged are not

If
in accordance with the
opinion of the committee, or if no opinion is delivered, the
Commission shall, without delay, submit
to the Council a
proposal relating to the measures to be taken. The Council
shall act by a qualified majority.

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C 120 E/109

INITIAL PROPOSAL

AMENDED PROPOSAL

If, on the expiry of a period of three months from the date of
referral to the Council, the Council has not acted, the proposed
measure shall be adopted by the Commission.

Article 24

Article 23

Consultation of scientific committees

Unchanged

The appropriate scientific committees shall be consulted on any
matter falling within the scope of this Regulation which is
likely to have an effect on public health.

Article 25

Article 24

Communication of national provisions

Unchanged

The Member States shall communicate to the Commission the
text of all provisions of national law which they adopt in the
field covered by this Regulation.

Article 26

Entry into force

Unchanged

Article 25

This Regulation shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
European Communities.

It shall apply from 1 July 2000.

It shall apply from 1 July 2001.

This Regulation shall be binding in its entirety and directly
applicable in all Member States.

Unchanged

ANNEX I

DEFINITIONS

(a) indigenous case of BSE: a case of BSE which has been clearly demon-
live cattle,

strated to originate directly from the importation of
bovine embryos or ova;

(a) indigenous case of BSE: a case of BSE which has not been clearly
demonstrated to originate directly from the importation of
live
cattle, bovine embryos or ova;

(b) batch of animals: a group of animals slaughtered after one complete
the slaughter

process of emptying, cleaning and disinfecting of
room and before the next such process;

Unchanged

(c) rendered ruminant fat: rendered fats derived in part or entirely from

ruminant animals;

(d) mechanically separated meat: residual meat obtained by mechanical

means from flesh-bearing bones after initial boning;

(e) discrete adipose tissue: internal and external body fat removed during
the slaughter and cutting process, in particular fresh fat from the
heart, caul, kidneys and mesentery of bovine animals, and fat from
cutting rooms;

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INITIAL PROPOSAL

AMENDED PROPOSAL

(f)

cohort: a group of animals which were reared together during the
first year of their life;

(g) ovine or caprine animals for breeding and fattening: ovine and caprine
animals intended to be transported to the place of destination,
either directly or via and approved market or assembly centre,
slaughter, meaning
other
animals of
the ovine or caprine species intended to be taken
either directly or via an approved market or assembly centre to a
slaughterhouse in order to be slaughtered there;

than ovine or caprine animals

for

(h) fresh meat: fresh meat as defined by Council Directive 64/433/EEC;

(i) minced meat and meat preparations: minced meat and meat prep-

arations as defined by Directive 94/65/EC;

(j) meat products: meat products as defined by Directive 77/99/EEC;

(k) official passport: passport as defined by Council Regulation (EC) No

820/97 (1);

(l) official computerised identification and tracing system: a database system

as provided for by Regulation (EC) No 820/97;

___________
(1) OJ L 117, 7.5.1997, p. 1.

ANNEX II

DETERMINATION OF BSE STATUS

CHAPTER A

Unchanged

Information to be submitted in support of an application for
recognition of risk classification under Article 5

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 incomplete
or are considered as unsatisfactory may be completed by reference to
other sources of information available to the Commission, or may have
to be replaced by a worst-case assumption for the purposes of a risk
assessment.

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INITIAL PROPOSAL

AMENDED PROPOSAL

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 and
a system of control and possible sanctions in accordance with
Community legislation on animal identification and registration.

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 particularly 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 particularly 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.

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INITIAL PROPOSAL

AMENDED PROPOSAL

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.

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
schemes;

for

reporting cases,

compensation and reward

(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 rendered

animal fat 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.

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INITIAL PROPOSAL

AMENDED PROPOSAL

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.

CHAPTER B

Definition of categories

I. For the purpose of determining the BSE status of Member State or

regions thereof, the following categories are recommended:

Category 1

1. a risk assessment based on the information laid down in
Chapter A has demonstrated that appropriate measures have
been taken to manage any risk identified;

2. the measures laid down in Articles 6, 7, 11 and 12 have been

complied with for at least seven years;

3. all cases of BSE have been clearly demonstrated to originate
directly from the importation of
live cattle, embryos or ova
and the measures laid down in Article 12 and 13 have been
applied with respect to all animals in which the disease has been
confirmed.

However, where the measures laid down in Articles 6 and 7 are not
complied with, the Member State or region thereof may be placed
in Category 1 provided that:

(cid:151) the measures laid down in Articles 11 and 12 have been

complied with for at least seven years; and

(cid:151) it has been proven that for at least eight years no ruminant

meat-and-bone meal has been fed to ruminants.

However, where indigenous cases of BSE have occurred,
the
Member State or region thereof may be placed in Category 1
provided that:

(cid:151) the last indigenous case of BSE occurred more than seven years

ago; and,

(cid:151) the measures laid down in Articles 6, 7, 11 and 12 have been

complied with for at least seven years; and,

(cid:151) the measures laid down in Article 9 are complied with and

have been effectively enforced for at least eight years.

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Category 2

1. a risk assessment based on the information laid down in
Chapter A has demonstrated that appropriate measures have
been taken to reduce any risk identified;

2. the measures laid down in Articles 6, 7, 11 and 12 are complied

with, but have not been complied with for seven years;

3. all cases of BSE have been clearly demonstrated to originate
directly from the importation of
live cattle, embryos or ova
and the measures laid down in Article 12 and 13 have been
applied with respect to all animals in which the disease has been
confirmed.

However, where the measures laid down in Articles 6 and 7 are not
complied with, the Member State or region thereof may be placed
in Category 2 provided that:

(cid:151) measures laid down in Articles 11 and 12 are complied with

but have not been complied with for seven years; and,

(cid:151) it has been proven that

for at

least eight years no meat-

and-bone meal has been fed to ruminants.

However, where indigenous cases of BSE have occurred,
the
Member State or region thereof may be placed in Category 2
provided that:

(cid:151) the last indigenous case of BSE occurred more than seven years

ago; and either

(cid:151) the measures laid down in Articles 6, 7, 11 and 12 are complied
with but have not been complied with for seven years; or

(cid:151) the measures laid down in Article 9 are complied with but have

not been effectively enforced for eight years.

However, where indigenous cases of BSE have occurred during the
past seven years, the Member State or region thereof may be placed
in Category 2 provided that:

(cid:151) the measures laid down in Articles 6, 7, 11 and 12 have been

complied with for seven years; and,

(cid:151) the BSE incidence rate, calculated on the basis of indigenous
cases during the past 12 months, has been less than 1 case per
million within the cattle population over 24 months of age in
the Member State or region thereof.

Category 3

1. a risk assessment based on the information laid down in
Chapter A has demonstrated that appropriate measures have
been taken to reduce any risk identified;

2. the measures laid down in Articles 6, 7, 11 and 12 are complied

with;

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3. the BSE incidence rate, calculated on the basis of indigenous
cases during the past 12 months, has been greater than or
equal to 1 case per million and less than or equal to 200
cases per million within the cattle population over 24 months
of age in the Member State or region thereof.

However, where the BSE incidence rate, calculated on the basis of
indigenous cases during the past 12 months, has been less than 1
case per million within the cattle population over 24 months of age
in the Member State or region thereof, the Member State or region
thereof shall also be placed in Category 3 if one or more of the
requirements of points (1) and (2) of Category 2 are not met.

However, where there has been no case of BSE, the Member State
or region thereof shall also be placed in Category 3 if:

(cid:151) a risk assessment based on the information laid down in
the
Chapter A has been conducted which demonstrates
presence of one or more risk factors; and

(cid:151) the measures laid down in Articles 11 and 12 are not complied

with.

Category 4

1. a risk assessment based on the information laid down in Annex
II Chapter A has demonstrated that appropriate measures have
been taken to reduce any risk identified;

1. a risk assessment based on the information laid down in
Chapter A has demonstrated that appropriate measures have
been taken to reduce any risk identified;

2. the measures laid down in Articles 6, 7, 11 and 12 are complied

Unchanged

with;

3. the BSE incidence rate, calculated on the basis of indigenous
cases during the past 12 months, has been greater than 200
cases per million within the cattle population over 24 months of
age in the Member State or region thereof.

However, where the BSE incidence rate, calculated on the basis of
indigenous cases during the past 12 months, has been greater than
or equal to 1 case per million and less than or equal to 200 cases
per million within the cattle population over 24 months of age in
the Member State or region thereof, the Member State or region
thereof shall be placed in Category 4 if one or more of
the
requirement of point (1) or the measures laid down in Articles 6,
7, 11 and 12 are not met.

Where a Member State or region thereof should be placed in
Category 4 pursuant to the criterion of point (3), but one or
more of
(1) and the measures laid
down in Articles 6, 7, 11 and 12 are not met, the Member State
or region thereof shall be placed in Category 4 and Article 4
applies.

the requirement of point

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II. For the purpose of determining the BSE status of third countries or
regions thereof, the same four categories on the basis of equivalent
health guarantees shall be defined providing equivalent health guar-
antees to those referred to in Part I.

III. Where an animal moves from one category of a country or region
to another,
it shall acquire or retain the highest numerical BSE
category of any country or region in which it has been kept for
more than 24 hours, unless adequate guarantees can be provided
that the animals were not fed with feed from that country or
region with the highest numerical BSE category.

ANNEX III

MONITORING SYSTEM

CHAPTER A

Unchanged

Minimal requirements for a programme for monitoring of BSE
and scrapie

Selection of subpopulation

Without prejudice to Article 12, selection must be by means of a risk
assessment of subpopulations of native-born animals displaying clinical
signs compatible with TSEs and, in a decreasing order of relevance, of
higher-risk animals. Within each subpopulation and age group,
selection must be random.

Animals examined in accordance with Article 12 may be included in
the sample.

1. Criteria for the selection of native-born animals displaying clinical

signs compatible with TSEs:

(cid:151) animals displaying behavioural or neurological signs lasting for
at least 15 days and resistant to treatment. However, animals
displaying such signs which die within 15 days and in which
case an alternative diagnosis has not been identified, should be
considered as suspect animals. They shall be examined in
accordance with Article 12 and may be included in the moni-
toring programme;

(cid:151) moribund animals without signs of

infectious or traumatic

illness;

(cid:151) animals displaying other progressive disease conditions.

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2. The following risks must be taken into account for the selection of

higher risk animals:

(cid:151) animals originating from countries with indigenous TSE;

(cid:151) animals which have consumed potentially contaminated feed-

ingstuffs;

(cid:151) animals born or derived from TSE infected dams or sires.

Animal species and type of TSE

1. Bovine animals must be examined for the presence of BSE.

2. Ovine and caprine animals must be examined for the presence of

scrapie and BSE.

Age of the targeted animals

target

The sample must
the oldest animals in the subpopulation.
However, all targeted bovine animals must be over 20 months of age
and all targeted ovine and caprine animals must be over 12 months of
age. Targeted bovine animals displaying progressive disease conditions
without showing neurological signs must be over four years of age.

Sample size

The minimum number of animals to be examined on an annual basis
must comply at least with the sample sizes referred to in the Table for
animals in subpopulations of native-born animals displaying clinical
signs compatible with TSEs. Suspected animals which have been
examined in accordance with Article 12 may be included within the
minimum sample size.

Samples from the subpopulations of higher-risk animals must be
collected at the time when the animals are slaughtered or killed.

Table

Minimum number of annual neurohistological investigations of
animals showing clinical signs compatible with TSE

Native-born cattle population
20 months of age or older or
native-born ovine and caprine population
12 months of age or older

Minimum number of brains
to be examined

100 000

300 000

500 000

700 000

1 000 000

2 500 000

5 000 000

7 000 000

10 000 000

20 000 000

30 000 000

40 000 000

10

30

50

69

99

195

300

336

367

409

425

433

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CHAPTER B

Annual report

The annual report must contain data on:

1. the total number of animals and age structure examined within the
different groups of the respective populations of bovine, ovine and
caprine animals categorised according to epidemiological criteria;

2. the overall mortality and mortality due to neurological diseases per

animal species;

3. official records on the number and types of animals or carcasses
placed under movement restrictions in accordance with Article 12;

4. the number and outcome of
accordance with Article 12;
least seven years;

the investigations carried out

these records must be kept

in
for at

5. TSEs in animals other than bovine, ovine and caprine animals;

6. training, in particular of official veterinarians with responsibilities
for the epidemiosurveillance of TSEs, in accordance with Article 6.

ANNEX IV

SPECIFIED RISK MATERIAL

1. The following tissues shall be designated as specified risk materials
depending on the category of the country of origin or residence of
the animal, determined in accordance with Article 5:

Unchanged

Category 1

No tissues are designated as specified risk materials.

Category 2

In countries or regions thereof placed in Category 2 the following
are only designated as specified risk materials where BSE has
occurred (1):

(a) the brain and spinal cord of:

(cid:151) bovine animals aged over 30 months,

___________
(1) Pending OIE confirmation during the legislative process.

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(cid:151) ovine and caprine animals which are aged over 12 months or

have a permanent incisor erupted through the gum;

(b) the distal ileum and spleen of ovine and caprine animals of all

ages.

Category 3

(a) the entire head excluding the tongue, including the brain and
dura mater, pituitary gland, eyes, trigeminal ganglia and tonsils;
the spinal cord and dura mater of bovine animals aged over six
months and of ovine and caprine animals aged over 12 months;

(b) the distal ileum of bovine, ovine and caprine animals, and spleen

of ovine and caprine animals of all ages.

Category 4 (1)

(a) the entire head excluding the tongue, including the brain and
dura mater, pituitary gland, eyes, trigeminal ganglia and tonsils;
the thymus; the intestines from the duodenum to the rectum;
the vertebral column, including dorsal root ganglia, spinal cord
and dura mater of bovine animals aged over six months and of
ovine and caprine animals aged over 12 months;

(b) and other bones of bovine animals aged over 30 months;

Deleted

(c) the distal ileum and spleen of bovine, ovine and caprine animals

(b) the distal ileum and spleen of bovine, ovine and caprine animals

of all ages.

of all ages.

2. Member States shall ensure that the specified risk materials are

Unchanged

removed at slaughterhouses.

However, in Member States or regions thereof which are not placed
in Category 4, the removal and subsequent destruction according to
point 4 of specified risk materials from raw material
for the
production of rendered ruminant fat derivatives is not required
provided that
the derivatives are produced in accordance with
Annex VI.

3. By way of derogation from point 2, Member States may allow the

removal of:

(a) specified risk material at cutting plants, high risk processing
plants or premises
referred to in Article 7 of Council
Directive 90/667/EEC (2), under the direct supervision of an
official of the competent authority. Those establishments shall
be approved for that purpose by the competent authority;

(a) specified risk material at cutting plants, high risk processing
plants or premises
referred to in Article 7 of Council
Directive 90/667/EEC (2), under the supervision of an official
of
shall be
the competent authority. Those establishments
approved for that purpose by the competent authority;

(b) the vertebral column or bones at

the point of sale to the

Unchanged

consumer on their territory.

Member States shall set up a system to ensure and check that, where
the removal of specified risk materials takes place at establishments
other than slaughterhouses, those materials are completely separated
from other waste, are collected separately and are disposed of in
accordance with point 4.

___________
(1) Pending OIE confirmation during the legislative process.
(2) OJ L 363, 27.12.1990, p. 51.

___________
(2) OJ L 363, 27.12.1990, p. 51.

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4. Member States shall ensure that specified risk material is stained
with a dye immediately on removal, and that all specified risk
material is completely destroyed:

(a) by direct incineration; or,

(b) provided that the colour of the dye is detectable after processing,

by processing followed by:

(i) incineration;

(ii) burning as fuel; or,

(iii) another method, which precludes all risk of transmission of
a TSE, and is authorised and supervised by the competent
authority.

5. Without prejudice to Articles 12 and 13, where bovine, ovine or
caprine animals have died or have been killed in the context of
disease control measures, Member States may allow disposal of
the entire body of those animals without removal of the specified
risk materials.

6. Member States may derogate from the provisions of points (2) and
(4) to allow the burning or burial of specified risk material or entire
bodies, without prior staining, or, as appropriate, removal of the
specified risk materials, in the circumstances set out in Directive
90/667/EEC.

7. The application of a test as an alternative to the removal of specified
risk materials may be authorised under the following conditions:

(a) tests are carried out in slaughterhouses on all animals eligible for

the removal of specified risk materials;

(b) no bovine, ovine or caprine product intended for human food or
animal feed leaves the slaughterhouse before the results of the
tests on all slaughtered animals produced in the same batch have
been received and accepted by the competent authority;

(c) when a post-slaughter test gives a positive result, all bovine,
ovine and caprine material produced in the same batch is
destroyed in accordance with point 4.

8. By way of derogation from Article 8 the Commission may;

Deleted

(a) acting in accordance with the procedure laid down in Article 22,
take a decision in respect of the date of effective enforcement of
the provisions of Article 9(1), or as appropriate, the prohibition
on the feeding of mammalian protein to ruminants in each
country or region thereof placed in Category 2 or 3, and
allow the provisions of Article 8 to be confined to animals
which were born before that date in those countries or regions;

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(b) after consultation of the appropriate scientific committee and
based on an assessment of
the incident, propagation and
human exposure risk, acting in accordance with the procedure
laid down in Article 22, take a decision to allow the use of
vertebral column and dorsal root ganglia for food, feed and
fertilisers from animals in or coming from each country or
region thereof in Category 4.

9. Member States shall carry out frequent official controls, particularly
in slaughterhouses, cutting plants, animal waste processing plants,
high risk processing plants or premises referred to in Article 7 of
Directive 90/667/EEC, points of sale to the consumer and storage
facilities, and shall ensure that measures are taken to avoid contami-
nation.

8. Member States shall carry out frequent official controls, particularly
in slaughterhouses, cutting plants, animal waste processing plants,
high risk processing plants or premises referred to in Article 7 of
Directive 90/667/EEC, points of sale to the consumer and storage
facilities, and shall ensure that measures are taken to avoid contami-
nation.

ANNEX V

ANIMAL FEEDING

1. In Member States, or regions thereof, which are placed in Category

4, the following shall be prohibited:

(a) the feeding to any farmed animal of protein derived from

mammals;

prohibition laid down in Article 9(2)(b)
production of dog food.

shall not apply to the

(b) the feeding to any mammal of protein derived from ruminants,
this prohibition shall not apply to the production of dog food.

The prohibition laid down in Article 9(1) and (2) shall not apply to the
following products:

2. The prohibition laid down in Article 9(1) and (2) shall not apply to

the following products:

(a) milk and milk products;

Unchanged

(b) hydrolysed proteins derived from fleshings from hides;

(c) dried plasma and other blood products,

(c) dried plasma and other blood products, with the exception of

bovine blood products for feeding to ruminants;

(d) gelatine derived from hides and skins.

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STANDARDS FOR CERTAIN PRODUCTS OF ANIMAL ORIGIN DERIVED FROM OR CONTAINING
RUMINANT MATERIAL

ANNEX VI

1. Conditions for production of certain products of animal origin as referred

Unchanged

to in Article 10(1)

The use of ruminant material for the production of the following
products of animal origin is prohibited:

(a) mechanically separated meat;

(b) dicalcium phosphate destined for feeding to all farmed animals;

(c) gelatine, unless it is produced from ruminant hides;

(d) rendered ruminant fat derivatives;

(e) rendered ruminant fat, unless it is produced from:

(i) discrete adipose tissue, which itself was found fit for human

consumption;

(ii) raw material which has been processed in accordance with
the standards laid down pursuant to Directive 90/667/EEC.

The prohibition on the use of ruminant material shall not apply to
material derived from animals which have been tested in accordance
with Annex IV, point 7, and have given a negative result.

2. Appropriate production processes

rendered ruminant

For
fat derivatives derived from ruminant
materials for use in the production of human food, animal feed
or fertilisers: validated and strictly certified methods such as:

1. Transesterification or hydrolysis at not less than 200 (cid:176)C for not
less than 20 minutes under pressure (glycerol, fatty acids and
fatty acid esters production); or,

2. Saponification with NaOH 12 M (glycerol and soap production):

(cid:151) in a batch process: at not less than 95 (cid:176)C for not less than

three hours; or

(cid:151) in a continuous process: at not less than 140 (cid:176)C, two bars for

not less than eight minutes, or equivalent.

Moreover, other tallow derivatives (e.g. fatty alcohols, fatty amines,
fatty amides) produced from the above mentioned products and
submitted to further processes may also be used.

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ERADICATION OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY

ANNEX VII

1. The inquiry referred to in Article 13(1)(b) shall identify:

Unchanged

(a) in the case of bovine animals:

(cid:151) all other ruminants on the holding of the animal in which

the disease was confirmed;

(cid:151) all embryos, ova and first generation progeny of a female
animal
in which the disease was confirmed and which
embryos or progeny were collected or born after or within
two years before clinical onset or diagnosis of the disease in
its dam;

Unchanged

(cid:151) all animals of the cohort of the animal in which the disease

was confirmed;

(cid:151) the possible origin of the disease and other holdings on
which there are animals which may have become infected
by the TSE agent or exposed to the same feed or contami-
nation source;

(cid:151) the movement of potentially contaminated feedingstuffs,
animals, ova, semen or embryos, or any other means of
transmission, which may have transmitted the TSE agent to
or from the holding in question.

(b) in the case of ovine and caprine animals:

(cid:151) all other ruminants on the holding of the animal in which

the disease was confirmed;

(cid:151) the parents, all semen, embryos, ova and first generation
progeny of the animal in which the disease was confirmed;

(cid:151) all animals of the cohort of the animal in which the disease

was confirmed;

(cid:151) the possible origin of the disease and the identification of
other holdings on which there are animals which may have
become infected by the TSE agent or exposed to the same
feed or contamination source;

(cid:151) the movement of potentially contaminated feedingstuffs,
animals, ova, semen or embryos, or any other means of
transmission, which may have transmitted the TSE agent to
or from the holding in question.

2. The requirement of Article 13(2) shall:

(a) in case of confirmation of BSE in a bovine animal, apply to
bovine animals, embryos and ova identified by the inquiry
referred to in point (1)(a), first and second indent;

(a) in case of confirmation of BSE in a bovine animal, apply to
bovine animals, embryos and ova identified by the inquiry
referred to in point (1)(a), first, second and third indent;

(b) in case of confirmation of BSE in an ovine or caprine animal,
apply to all ruminant animals, embryos and ova and ovine and
caprine semen identified by the inquiry referred to in point
(1)(b), first to fifth indent.

Unchanged

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PLACING ON THE MARKET OF LIVE ANIMALS, SEMEN, EMBRYOS AND OVA

ANNEX VIII

CHAPTER A

Unchanged

Conditions for placing on the market

I. CONDITIONS WHICH APPLY IRRESPECTIVE OF THE CATEGORY
OF THE COUNTRY OF ORIGIN OR RESIDENCE OF THE ANIMAL

1. The conditions as referred to in Article 15(1) shall apply to

movements relating to:

(cid:151) dispatch to other Member States;

(cid:151) dispatch to third countries;

(cid:151) import into the Community from third countries.

2. The following conditions shall apply to movements as referred

to in point (1) of bovine embryos and ova:

Bovine embryos and ova shall be derived from female animals
which, at the time of collection:

(cid:151) were not suspected of being affected by BSE;

(cid:151) themselves complied with the conditions laid down in Part

II.

3. The following conditions shall apply to movements as referred

to in point (1) of ovine and caprine animals:

Ovine or caprine animals for breeding or fattening shall:

(a) come from a holding satisfying the following requirements:

(cid:151) the animals are identified;

(cid:151) no case of scrapie has been confirmed for at least two

(cid:151) no case of scrapie has been confirmed for at least six

years;

years;

(cid:151) checking by sampling is carried out at slaughter on old
female animals, intended for culling coming from that
holding;

Unchanged

(cid:151) female animals are only introduced into that holding if
they come from a holding which complies with the
same requirements;

(b) have been continuously kept on a holding or holdings
complying with the requirements laid down in point (a)
since birth or for the last two years.

(b) have been continuously kept on a holding or holdings
complying with the requirements laid down in point (a)
since birth or for the last six years.

4. Ovine or caprine animals imported into the Community shall
meet requirements which provide equivalent health guarantees
to those required by this Regulation or pursuant to this Regu-
lation.

Unchanged

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II. CONDITIONS WHICH APPLY DEPENDING ON THE CATEGORY
OF THE COUNTRY OF ORIGIN OR RESIDENCE OF THE ANIMAL
DETERMINED IN ACCORDANCE WITH ANNEX II, CHAPTER B

1. The conditions as referred to in Article 15(1) shall apply to

movements relating to:

(cid:151) dispatch to other Member States;

(cid:151) dispatch to third countries;

(cid:151) import into the Community from third countries.

2. The BSE category of bovine, ovine and caprine animals shall be

communicated to the Member State of destination.

3. The following conditions shall apply to movements as referred
to in point (1) of bovine animals coming from or having resided
in countries or regions thereof placed in:

Category 2 and 3

The animals must have:

(a) been born, raised and have remained in herds in which no
case of BSE had been confirmed for at least seven years; or

(b) been born after the date at which ban on the feeding of
from

ruminants with meat-and-bone meal
mammalians has been effectively enforced.

derived

In addition bovine animals imported into the Community shall
come from a country or region thereof in which:

(a) the BSE affected cattle are killed and completely destroyed;

(b) the feeding of ruminants with meat-and-bone meal derived
from mammalians has been banned and the ban has been
effectively enforced.

Category 4

The animals must have:

(a) never been fed mammalian meat-and-bone meal and been
born after the date at which the ban on the feeding of
farmed animals with meat-and-bone meal derived from
mammalians has been effectively enforced;

(b) been born, raised and have remained in herds in which no
case of BSE had been confirmed for at least seven years, and
which contain only cattle born on the farm or coming from
a herd of equal status.

In addition, bovine animals imported into the Community shall
come from a country or a region thereof in which the BSE
affected cattle are killed and completely destroyed.

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CHAPTER B

AMENDED PROPOSAL

Identification of live animals on import

The requirement laid down in Article 15(2) shall apply to:

(cid:151) bovine animals.

CHAPTER C

Conditions relating to progeny of TSE suspect or confirmed
animals referred to in Article 15(3)

It is prohibited to place on the market:

(cid:151) the first generation progeny, embryos and ova of TSE suspect or

confirmed female bovine animals;

(cid:151) the first generation progeny, semen, embryos and ova of BSE

confirmed ovine and caprine animals.

CHAPTER D

Animal health certificates

1. The certificates referred to in Article 15(1) shall be required for
animals and semen, embryos and ova of those animals when:

(cid:151) dispatched to other Member States;

(cid:151) imported into the Community from third countries.

2. The certificates shall be supplemented in accordance with the

following conditions:

(a) Intra-Community trade in bovine animals

The animal health certificates referred to in Annex F to Council
Directive 64/432/EEC (1) shall be supplemented by the following
words to be entered in the section (cid:145)Health data concerning
bovine animals(cid:146):

(cid:145)The animals listed below comply with the conditions laid
down in Regulation [. . ./. . .] of the European Parliament
and of the Council, and their BSE category is Category
. . . (*). This category was established by Commission
Decision [. . ./. . .] (**);
___________
(*) Complete as appropriate with 1, 2, 3 or 4.
(**) Complete.(cid:146)

___________
(1) OJ 121, 29.7.1964, p. 1977/64.

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(b) Intra-Community trade in ovine and caprine animals

in
The animal health certificates corresponding to Model
Annex E to Council Directive 91/68/EEC (1) shall be supple-
mented by the following words to be entered in section V
(cid:145)Health information(cid:146):

III

(cid:145)BSE category of the animals listed below: Category . . . (*).
This category was established by Commission Decision
[. . ./. . .] (**);
___________
(*) Complete as appropriate with 1, 2, 3 or 4.
(**) Complete.(cid:146)

(cid:145)BSE category of the animals listed above: Category . . . (*).
This category was established by Commission Decision
[. . ./. . .] (**);
___________
(*) Complete as appropriate with 1, 2, 3 or 4.
(**) Complete.(cid:146)

(e) of section V (cid:145)Health information(cid:146) of

the certificate
III in Annex E to Council Directive

Point
corresponding to Model
91/68/EEC states that:

Unchanged

(cid:145)(e)

they meet the requirements with regard to scrapie laid
down in Article 15 of Regulation [. . ./. . .] of
the
European Parliament and of the Council.(cid:146)

(c) Intra-Community trade in bovine embryos and ova

The appropriate animal health certificates as laid down in
Community rules on trade in bovine embryos and ova shall
be supplemented by the following words to be entered in the
section on health data:

(cid:145)The embryos and ova were derived from females which, at
the time of collection, were not suspected of being affected
by BSE, and which themselves complied with the conditions
laid down in Regulation [. . ./. . .] of the European Parliament
and of the Council. The BSE category of the Member State,
or region within a Member State, in which the embryos or
ova were collected,
is Category . . . (*). This category was
established by Commission Decision [. . ./. . .] (**);
___________
(*) Complete as appropriate with 1, 2, 3 or 4.
(**) Complete.(cid:146)

(cid:145)The embryos and ova were derived from females which, at
the time of collection, were not suspected of being affected
by BSE, and complied with the conditions laid down in
Regulation [. . ./. . .] of the European Parliament and of the
Council. The BSE category of the Member State, or region
within a Member State, in which the embryos or ova were
collected, is Category . . . (*). This category was established
by Commission Decision [. . ./. . .] (**);
___________
(*) Complete as appropriate with 1, 2, 3 or 4.
(**) Complete.(cid:146)

(d) Intra-Community trade in ovine or caprine semen, embryos or ova

Unchanged

The appropriate animal health certificates as laid down in
semen,
Community rules on trade
embryos and ova, shall be supplemented by the following
words to be entered in the section on health data:

in ovine or

caprine

the

time of

(cid:145)The semen, embryos and ova were derived from donor
animals which, at
collection, were not
suspected of being affected by either BSE or scrapie, and
which themselves complied with the conditions laid down
in Regulation [. . ./. . .] of the European Parliament and of
the Member State, or
the Council. The BSE category of
region within a Member State,
in which the semen,
is Category . . . (*) This
embryos or ova were collected,
category was
by Commission Decision
[. . ./. . .] (**);
___________
(*) Complete as appropriate with 1, 2, 3 or 4.
(**) Complete.(cid:146)

established

___________
(1) OJ L 46, 19.2.1991, p. 19.

at

the

time of

(cid:145)The semen, embryos and ova were derived from donor
animals which,
collection, were not
suspected of being affected by either BSE or scrapie, and
complied with the conditions laid down in Regulation
[. . ./. . .] of the European Parliament and of the Council.
The BSE category of the Member State, or region within a
Member State, in which the semen, embryos or ova were
collected, is Category . . . (*) This category was established by
Commission Decision [. . ./. . .] (**);
___________
(*) Complete as appropriate with 1, 2, 3 or 4.
(**) Complete.(cid:146)

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INITIAL PROPOSAL

AMENDED PROPOSAL

(e) Import into the Community of bovine, ovine and caprine animals

Unchanged

The appropriate certificates, as required by Community legis-
lation, shall be supplemented by the following words:

(cid:145)The animals listed below provide equivalent guarantees to
those of Regulation [. . ./. . .] of the European Parliament and
of the Council and their BSE category is Category . . . (*).
This category was established by Commission Decision
[. . ./. . .] (**);
___________
(*) Complete as appropriate with 1, 2, 3 or 4.
(**) Complete.(cid:146)

(f) Import into the Community of bovine embryos and ova

The appropriate certificates, as required by Community legis-
lation, shall be supplemented by the following words:

(cid:145)The embryos and ova were derived from females which, at
the time of collection, were not suspected of being affected
by BSE, and which themselves provide guarantees equivalent
to those of Regulation [. . ./. . .] of the European Parliament
and of the Council.

category was

The BSE category of the country, or region within a country,
is Category
in which the embryos or ova were collected,
. . . (*). This
established by Commission
Decision [. . ./. . .] (**);
___________
(*) Complete as appropriate with 1, 2, 3 or 4.
(**) Complete.(cid:146)

(g) Import into the Community of ovine or caprine semen, embryos or ova

The appropriate certificates, as required by Community legis-
lation, shall be supplemented by the following words:

(cid:145)The embryos and ova were derived from females which, at
the time of collection, were not suspected of being affected
by BSE, and provide guarantees equivalent to those of Regu-
lation [. . ./. . .] of
the
Council.

the European Parliament and of

Unchanged

the

(cid:145)The semen, embryos and ova were derived from donor
animals which, at
collection, were not
suspected of being affected by either BSE or scrapie, and
to those
which themselves provide guarantees equivalent
of Regulation [. . ./. . .] of the European Parliament and of
the Council.

time of

(cid:145)The semen, embryos and ova were derived from donor
animals which,
collection, were not
suspected of being affected by either BSE or scrapie, and
to those of Regulation
provide guarantees
[. . ./. . .] of the European Parliament and of the Council.

equivalent

time of

the

at

The BSE category of the country, or region within a country,
is
in which the semen, embryos or ova were collected,
by
. . . (*). This
Category
Commission Decision [. . ./. . .] (**);
___________
(*) Complete as appropriate with 1, 2, 3 or 4.
(**) Complete.(cid:146)

category was

established

Unchanged

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INITIAL PROPOSAL

AMENDED PROPOSAL

ANNEX IX

PLACING ON THE MARKET OF BOVINE, OVINE OR CAPRINE MEAT AND CERTAIN PRODUCTS OF
ANIMAL ORIGIN

CHAPTER A

Unchanged

Conditions for placing on the market

I. The following products of animal origin are exempt

from the
prohibition referred to in Article 16(2), provided that they are
derived from animals that comply with the conditions of Article
16(3):

(cid:151) fresh meat;

(cid:151) minced meat;

(cid:151) meat preparations;

(cid:151) meat products;

(cid:151) food which is destined for domestic carnivores.

(cid:151) petfood which is destined for domestic carnivores.

Date-Based Scheme (DBS)

Unchanged

tissues,

II. Deboned fresh meat of which all adherent

including
obvious nervous and lymphatic tissue has been removed, and the
products of animal origin referred to in Part I therefrom, derived
from eligible animals from countries or regions thereof in Category
4 may be marketed in accordance with Article 16(3)(a) when
obtained from animals born after the date at which the animal
effectively
feeding standards
enforced, and which are certified to meet
the conditions laid
down in point (1) and produced in establishments which meet
the condition laid down in point (10). The competent authority
shall ensure that
laid
the conditions with respect
down in points (2) to (8) and (10), are complied with.

laid down in Article 9 were

to controls,

1.

(a) The animal

is clearly identified, enabling it to be traced
back to the dam and herd of origin;
its unique eartag
number, date and holding of birth and all movements
after birth are recorded either
in the animal’s official
passport or on an official computerised identification and
tracing system; the identity of its dam is known;

(b) the animal

less than 30
is more than six months but
months of age, determined by reference to an official
computer record of its date of birth, or to the animal’s
official passport;

(c) the competent authority has obtained and verified positive
evidence that the dam of the animal has lived for at least
six months after the birth of the eligible animal;

(d) the dam of the animal has not developed BSE and is not

suspected of having contracted BSE.

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INITIAL PROPOSAL

AMENDED PROPOSAL

Controls

2. If any animal presented for slaughter or any circumstance
surrounding its slaughter does not meet all of the requirements
of this Regulation, the animal must be automatically rejected
information becomes
If
and its passport withheld.
authority must
the
available
issued
immediately cease
certificates.
the
competent authority must notify the competent authority of
the place of destination. The competent authority of the place
of destination must take the appropriate measures.

issuing certificates, and cancel
already

that
competent

dispatch has

taken place,

slaughter,

after

If

3. Slaughter of eligible animals must

take place in slaughter-
houses exclusively used for slaughter of animals under a
Date-based Scheme or under a Certified Animal Scheme.

4. The competent authority must ensure that procedures used in
the cutting plants ensure that the following lymph nodes have
been removed:

Popliteal, ischiatic, superficial inguinal, deep inguinal, medial
and lateral
lumbar, costocervical,
sternal, prescapular, axilliary and caudal deep cervical.

renal prefemoral,

iliac,

tracing system until

5. Meat must be traceable back to the eligible animal, or after
cutting, to the animals cut in the same batch, by means of an
official
slaughter. After
slaughter,
labels must be capable of tracing fresh meat and
products referred to in Part I back to the eligible animal to
enable the consignment concerned to be recalled. In case of
petfood accompanying documents and records must enable
tracing.

the time of

6. All approved eligible carcasses must have individual numbers

correlated with the ear tag number.

7. The Member State must have detailed protocols in place

covering:

(a) tracing and controls prior to slaughter;

(b) controls during slaughter;

(c) processing of petfood;

(c) controls during processing of petfood;

(d) all labelling and certification requirements after slaughter to

Unchanged

the point of sale.

8. The competent authority must set up a system for recording
checks on compliance so that control can be demonstrated.

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INITIAL PROPOSAL

AMENDED PROPOSAL

The establishment

9. To obtain approval,

the establishment must devise and
implement a system whereby the eligible meat and/or eligible
product is identifiable and all meat can be traced back to the
eligible animal, or after cutting, to the animals cut in the same
batch. The system must facilitate full traceability of the meat or
products of animal origin at all stages and records must be
retained for at least two years. Details of the system to be
employed must be given, in writing, by the management of
the establishment to the competent authority.

10. The competent authority must assess, approve and monitor the
system provided by the establishment in order to ensure that it
provides full segregation and traceability both backwards and
forwards.

Certified Animal Scheme (CAS)

III. Deboned fresh meat of which all adherent

tissues,

including
obvious nervous and lymphatic tissue has been removed, and the
products of animal origin referred to in Part I therefrom, derived
from eligible animals from countries or regions thereof in Category
4, may be marketed in accordance with Article 16(3)(b) when
obtained from animals which are certified to meet the conditions
laid down in point (2) and coming from herds in which no case of
BSE has occurred in the last seven years and which are certified to
meet the conditions laid down in point (1) and produced in estab-
lishments which meet the condition laid down in point (11). The
competent authority shall ensure that the conditions with respect
to the computerised tracing system and the controls, laid down in
points (3) to (10) and (12), are complied with.

Herd conditions

1.

(a) A herd is a group of animals forming a separate and
is a group of animals which is
distinct unit,
managed, housed and kept separately from any other
group of animals and which is identified with unique
herd and animal identification numbers.

that

(b) A herd is eligible when for at least seven years, there has
been no confirmed case of BSE, nor a suspect case for
which the diagnosis of BSE has not been ruled out,
in
any animal which was still in or had moved through or
from the herd.

(c) As an exception to the provisions in point (b), a herd that
has been in existence for less than seven years may be
considered eligible, after a thorough investigation by the
competent veterinary authority, on condition that:

(i) all animals born or moved into the newly established
herd complied with the conditions set out in point
(2)(a), (d) and (e); and,

(ii) the herd has complied with the conditions set out in

point b during its entire existence.

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INITIAL PROPOSAL

AMENDED PROPOSAL

(d) If a herd is newly established on a holding which
experienced a confirmed case of BSE in any animal
which was still in or had moved through or from a herd
on that holding, the newly established herd can only be
eligible after a thorough investigation by the competent
veterinary authority, taking into account compliance with
each of the following conditions to the satisfaction of that
authority:

(i) all animals of the affected herd previously established
on the same holding have been removed or killed;

(ii) all feed has been removed and destroyed and all feed

containers thoroughly cleansed;

(iii) all buildings have been emptied and thoroughly
cleansed before the new animals were admitted;

(iv) all conditions set out in point (c) have been complied

with.

Animal conditions

2.

(a) all

records of

its birth,

identity and movements are

recorded on an official computerised tracing system;

(b) it is more than six months but less than 30 months of age,
determined by reference to an official computer record of
its date of birth;

(c) its dam has lived for at least six months after its birth;

(d) its dam has not developed BSE and is not suspected of

having contracted BSE;

(e) the herd of birth of the animal and all herds through which

it has ever moved are eligible.

Computerised tracing system

3. The official computerised tracing system referred to in point
(2)(a) will be accepted only where it has been in operation for
sufficient time to contain all the information, relating to the
the animals, needed to check
lifetime and movements of
compliance with the requirements of
this Regulation, and
only in respect of animals born after the system came into
operation. Historical data loaded into a computer for any
system was operational will not be
period before
accepted for this purpose.

the

Controls

4. If any animal presented for slaughter or any circumstance
surrounding its slaughter does not meet all of the requirements
of this Regulation, the animal must be automatically rejected
information becomes
If
and its passport withheld.
authority must
the
available
issued
immediately cease
certificates.
the
competent authority must notify the competent authority of
the place of destination. The competent authority of the place
of destination must take the appropriate measures.

issuing certificates, and cancel
already

that
competent

dispatch has

taken place,

slaughter,

after

If

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INITIAL PROPOSAL

AMENDED PROPOSAL

5. Slaughter of eligible animals must

take place in slaughter-
houses, exclusively used for slaughter of animals under a
Date-based Scheme or under a Certified Animal Scheme.

6. The competent authority must ensure that procedures used in
the cutting plants ensure that the following lymph nodes have
been removed:

Popliteal, ischiatic, superficial inguinal, deep inguinal, medial
and lateral
lumbar, costocervical,
sternal, prescapular, axilliary and caudal deep cervical.

renal prefemoral,

iliac,

7. Meat must be traceable back to the herd of the eligible animal,
or after cutting, to the animals cut in the same batch, by
means of the computerised tracing system until the time of
labels must be capable of tracing
slaughter. After slaughter,
fresh meat and products referred to in Part I back to the
herd to enable the consignment concerned to be recalled. In
case of petfood accompanying documents and records must
enable tracing.

8. All approved eligible carcasses must have individual numbers

correlated with the ear tag number.

9. The Member State must have detailed protocols in place

covering:

(a) tracing and controls prior to slaughter;

(b) controls during slaughter;

(c) processing of petfood;

(c) controls during processing of petfood;

(d) all labelling and certification requirements after slaughter to

Unchanged

the point of sale.

10. The competent authority must set up a system for recording
checks on compliance so that control can be demonstrated.

The establishment

11. To obtain approval,

the establishment must devise and
implement a system whereby the eligible meat and/or eligible
product is identifiable and all meat can be traced back to its
herds of origin, or after cutting, to the animals cut in the same
batch. The system must facilitate full traceability of the meat or
products of animal origin at all stages and records must be
retained for at least two years. Details of the system to be
employed must be given, in writing, by the management of
the establishment to the competent authority.

12. The competent authority must assess, approve and monitor the
system provided by the establishment in order to ensure that it
provides full segregation and traceability both backwards and
forwards.

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INITIAL PROPOSAL

CHAPTER B

AMENDED PROPOSAL

Import into the Community of products of animal origin

I. Import

into the Community from countries or regions thereof,
placed in Category 4 of the products of animal origin referred to
in Article 16(3) shall be prohibited if they contain or are derived
from the following products or material derived from ruminant
animals:

(cid:151) mechanically separated meat;

(cid:151) dicalcium phosphate destined for feeding farmed species;

(cid:151) dicalcium phosphate destined for feeding farmed animals;

(cid:151) gelatine unless produced from hides;

Unchanged

(cid:151) rendered ruminant fat derivatives;

(cid:151) rendered ruminant fat unless produced from discrete adipose
tissue, which itself was found fit for human consumption, or
from raw material which has been processed in accordance with
the standards laid down pursuant to Directive 90/667/EEC.

II. The appropriate certificates, as required by Community legislation,

shall be supplemented by the following words:

(cid:145)The products of animal origin provide guarantees equivalent to
those of Regulation [. . ./. . .] of the European Parliament and of
the Council and originate from a country, or region within a
country in BSE Category . . . (*). This category was established
by Commission Decision [. . ./. . .] (**);
___________
(*) Complete as appropriate with 1, 2, 3 or 4.
(**) Complete.(cid:146)

When importing from third countries or regions thereof which are
not placed in Category 1, the appropriate certificates, as required by
Community legislation, shall be supplemented by declaration signed
by the competent authority of the country of production, worded as
follows:

(cid:145)The product does not contain, and is not derived from,
specified risk material as defined in Regulation [. . ./. . .] of
the European Parliament and of
the Council. The animals
have not been slaughtered by stunning or killing by means
of a gas injected into the cranial cavity, or slaughtered by
laceration after stunning of central nervous tissue by means
of an elongated rod-shaped instrument
introduced into the
cranial cavity(cid:146)

or

(cid:145)The product contains, or is derived from, material of bovine,
or as appropriate, ovine or caprine animals which were tested
and found negative for the presence of BSE using a test which
was approved in accordance with Commission Decision
[. . ./. . .](cid:146).

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INITIAL PROPOSAL

AMENDED PROPOSAL

ANNEX X

REFERENCE LABORATORIES, SAMPLING AND LABORATORY METHODS

CHAPTER A

Unchanged

National reference laboratories

1. The designated national reference laboratory shall:

(a) have at its disposal facilities and expert personnel enabling it to
show at all times, and especially when the disease in question
first appears the type and strain of the agent of TSEs, and to
confirm results obtained by regional diagnostic laboratories.
Where it is not capable of identifying the strain-type of the
agent, it shall set up a procedure to ensure that the identification
of the strain is referred to the Community reference laboratory;

(b) verify diagnostic methods used in regional diagnostic labora-

tories;

(c) be responsible for co-ordination of diagnostic standards and

methods within the Member State. To this end, it:

(cid:151) may provide diagnostic reagents to laboratories approved by

the Member State;

(cid:151) shall control the quality of all diagnostic reagents used in the

Member State;

(cid:151) shall periodically arrange comparative tests;

(cid:151) shall hold isolates, or

containing,
the agents of
cases confirmed in the Member State;

corresponding tissues, of, or
the disease in question from

(cid:151) shall ensure confirmation of results obtained in diagnostic

laboratories approved by the Member State.

(d) co-operate with the Community reference laboratory.

2. However, by way of derogation from point 1, Member States which
do not have a national reference laboratory shall use the services of
the Community reference laboratory or of national reference labo-
ratories in other Member States.

3. The national reference laboratories are:

Austria:

Belgium:

Denmark:

Germany:

Finland:

France:

Greece:

Ireland:

Italy:

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INITIAL PROPOSAL

AMENDED PROPOSAL

Luxembourg:

Netherlands:

Portugal:

Spain:

Sweden:

United Kingdom:

CHAPTER B

Community reference laboratory

1. The Community reference laboratory for TSEs is:

2. The functions and duties of the Community reference laboratory

are:

(a) to co-ordinate,

the
methods employed in the Member States for diagnosing trans-
missible spongiform encephalopathies, specifically by:

in consultation with the Commission,

(cid:151) storing and supplying corresponding tissues containing the
agent, for the development or production of the relevant
diagnostic tests, typing strains of the agent;

(cid:151) supplying standard sera and other reference reagents to the
national reference laboratories in order to standardise the
tests and reagents used in the Member States;

(cid:151) building up and retaining a collection of corresponding

tissues containing the agents and strains of TSEs;

(cid:151) organising

periodic
procedures at Community level;

comparative

tests

of

diagnostic

(cid:151) collecting and collating data and information on the
methods of diagnosis used and the results of tests carried
out in the Community;

(cid:151) characterising isolates of

the TSE agent by the most
up-to-date methods to allow greater understanding of the
epidemiology of the disease;

(cid:151) keeping abreast of

the developments in the surveillance,
epidemiology and prevention of TSEs throughout the world;

(cid:151) retaining expertise on prion diseases to enable rapid differ-

ential diagnosis;

(cid:151) acquiring a thorough knowledge of the preparation and use
of diagnostic methods used to control and eradicate TSEs;

(b) to assist actively in the diagnosis of outbreaks of TSEs in
Member States by receiving samples from TSE infected animals
for confirmatory diagnosis, characterisation and epidemiological
studies;

(c) to facilitate the training or retraining of experts in laboratory
diagnosis with a view to the harmonisation of diagnostic tech-
niques throughout the Community.

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INITIAL PROPOSAL

CHAPTER C

Sampling and laboratory methods

AMENDED PROPOSAL

1. The

framework of

tests performed in the

the monitoring
programme, referred to in Article 7, shall comprise on an annual
basis, a range of tests, including at least histopathology examination
of brain tissue,
immunodiagnostic tests for
the detection of scrapie associated fibrils (SAFs) and, when the
TSE occurs in ovine or caprine animals,
tests to identify the
strain-type of the agent.

immunocytochemical,

1. The

framework of

tests performed in the

the monitoring
programme, referred to in Article 7, shall comprise on an annual
basis, a range of tests, including at least histopathology examination
of brain tissue,
immunodiagnostic tests for
the detection of scrapie associated fibrils (SAFs) and, when the
TSE occurs in ovine or caprine animals, tests to identify the strain
of the agent.

immunocytochemical,

2. For confirmation of the suspected presence of a TSE, pursuant to
Article 12(2), the tests performed shall at least comprise histo-
pathology examination of brain tissue. The competent authority
may also require the use of other laboratory tests such as immu-
nocytochemical and immunodiagnostic tests for the detection of
scrapie associated fibrils (SAFs), where their use is considered appro-
priate. In case of a first appearance of the disease all three tests
should be performed.

2. For confirmation of the suspected presence of a TSE, pursuant to
Article 12(2), the tests performed shall at least comprise histo-
pathology examination of brain tissue. The competent authority
may also require the use of other laboratory tests such as immu-
nocytochemical and immunodiagnostic tests for the detection of
scrapie associated fibrils (SAFs), where their use is considered appro-
priate. In any event, at least one further laboratory test should be
carried out as specified in the preceding sentence if
the initial
histopathological examination yields a negative result. In case of a
first appearance of the disease all three tests should be performed.

3. The following test procedures shall be used as rapid diagnostic tests
this Regulation for testing purposes in

within the meaning of
accordance with Article 5(3) and Article 7(1):

(a) Immunoblotting test based on a western blotting procedure for
the detection of the protease-resistant fragment PrPRes (Prionics
Check test);

(b) Chemiluminescent ELISA involving an extraction procedure and
an ELISA technique, using an enhanced chemiluminescent
reagent (Enfer test);

(c) Sandwich immunoassay for PrPRes carried out following denatu-

ration and concentration steps (CEA Test).

AMENDED PROPOSAL

ANNEX XI

TRANSITIONAL MEASURES

Transitional measures for the removal of specified risk material as referred to in Article 20

1. Member States shall ensure that the specified risk materials as designated below are removed and destroyed in

accordance with points 6 to 11.

(a) The following tissues shall be designated as specified risk material:

(i) the skull including the brains and eyes, the tonsils, the spinal cord and the ileum of bovine animals aged

over 12 months;

(ii) the skull including the brains and eyes, the tonsils and the spinal cord of ovine and caprine animals aged
over 12 months or that have a permanent incisor erupted through the gum, and the spleen of ovine and
caprine animals of all ages.

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(b) In addition to the specified risk material listed in point 1(a) the following tissues shall be designated as specified
risk material in the United Kingdom of Great Britain and Northern Ireland and Portugal with the exception of
the Autonomous Region of the Azores:

(i) the entire head excluding the tongue, including the brains, eyes, trigeminal ganglia and tonsils; the thymus;
the spleen; the intestines from the duodenum to the rectum and spinal cord of bovine animals aged over 6
months;

(ii) the vertebral column, including dorsal root ganglia, of bovine animals aged over 30 months.

2. The specified risk materials or the processed material thereof may be dispatched only for arrangements of eventual

incineration in accordance with point 11, and, as appropriate point 7(b).

3. Member States shall ensure that bones of the head and vertebral columns of bovine, ovine and caprine animals shall

not be used for the production of mechanically recovered meat.

4. Member States shall ensure that the laceration, after stunning, of central nervous tissue by means of an elongated
rod-shaped instrument introduced into cranial cavity shall not be used on their territory on bovine, ovine or caprine
animals whose meat is destined for human or animal consumption.

5. The specified risk materials referred to in point 1(a) shall not be imported into the Community [after 31 March

2001].

The following products of animal origin shall be subject to restrictions on import into the Community:

(cid:151) fresh meat: fresh meat as defined by Directive 64/433/EEC on health problems affecting intra-Community trade

in fresh meat;

(cid:151) minced meat and meat preparations: minced meat and meat preparations as defined by Directive 94/65/EC;

(cid:151) meat products: meat products as defined by Directive 77/99/EEC;

(cid:151) processed animal protein, as referred to by Directive 92/118/EEC.

(a) Where the products of animal origin listed above, containing material derived from bovine, ovine or caprine
animals, are imported into the Community [after 31 March 2001] from third countries or regions thereof, the
appropriate health certificate shall be supplemented by a declaration signed by the competent authority of the
country of production, worded as follows:

(cid:145)The product of animal origin does not contain, and is not derived from, specified risk material as defined in
point 1(a), produced [after 31 March 2001], or mechanically recovered meat obtained from the bones of the
head or vertebral column of bovine, ovine or caprine animals, produced [after 31 March 2001]. The animals
have not been slaughtered [after 31 March 2001], after stunning by means of a gas injected into the cranial
cavity or killed instantaneously by the same method, or slaughtered after laceration, after stunning, of central
nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity.(cid:146)

(b) Any reference to (cid:145)products of animal origin(cid:146) is a reference to the products of animal origin listed in this point,

not to other products of animal origin containing or derived from those products of animal origin.

6. The provisions of point 5 shall only apply to import from third countries:

(a) which have not submitted a dossier to the Commission in support of their request to be exempted from these

provisions;

(b) which have submitted such a dossier but for which the outcome of a risk assessment identifying all potential

risk factors is not satisfactory.

24.4.2001

EN

Official Journal of the European Communities

C 120 E/139

7. Member States shall carry out frequent official controls to verify the correct application of this Decision and ensure
that measures are taken to avoid contamination, particularly in slaughterhouses, cutting plants, animal waste
processing plants, high risk processing plants or premises authorised by the Member States in accordance with
Article 7 of Directive 90/667/EEC, points of sale to the consumer, landfill sites and other facilities for storage or
incineration. They shall in particular set up a system to ensure and check that:

(a) specified risk materials used in the production of products referred to in Article 1(2) are exclusively used for the

authorised purpose;

(b) specified risk materials, in particular where the removal takes place at establishments or premises other than
slaughterhouses, are completely separated from other waste not destined for incineration, are collected sepa-
rately and are disposed of in accordance with point 1, 8 to 11. Member States may decide to allow dispatch of
heads or carcasses containing specified risk material to another Member State after agreement with that other
Member State both to receive the material and to the specific conditions to be applied to such movements.

8. Member States shall ensure that the specified risk materials are removed at:

(a) slaughterhouses;

(b) cutting plants, high risk processing plants or premises referred to in Article 3 and 7 of Directive 90/667/EEC,
under the supervision of a designated agent appointed by the competent authority. Those establishments shall be
approved for that purpose by the competent authority.

Where specified risk materials are not removed from dead animals not slaughtered for human consumption, the
parts of the body containing the specified risk materials or the entire body shall be treated as specified risk material.

However, the vertebral column may be removed at the point of sale to the consumer on their territory.

9. Member States shall ensure that all specified risk material is stained with a dye and, as appropriate, marked with a

marker immediately on removal, and is completely destroyed:

(a) by incineration without pre-processing; or,

(b) provided that the dye or marker remains detectable, after pre-processing:

(i) in accordance with the systems described in Chapters I to IV, VI and VII of Annex to Commission Decision

92/562/EEC (1):

(cid:151) by incineration;

(cid:151) by co-incineration;

(ii) in accordance with at least the standards referred to in Annex I to Council Decision 1999/534/EC (2), by

burial in an approved landfill site.

10. Member States may derogate from the provisions of points 8 and 9 to allow the incineration or burial of specified
risk material or entire bodies, without prior staining, or, as appropriate, removal of the specified risk materials, in
the circumstances set out in Article 3(2) of Directive 90/667/EEC and by a method, which precludes all risk of
transmission of a TSE, and is authorised and supervised by the competent authority, in particular where animals
have died, or have been killed in the context of disease control measures.

11. Member States may send specified risk material or the processed material thereof to other Member States for
incineration under the conditions laid down in Article 4(2) of Commission Decision 97/735/EC (3), as applicable.

This point may be amended on request of a Member State to allow the dispatch of specified risk material or the
the conditions
thereof
processed material
governing the exportation.

to third countries for incineration,

together with the adoption of

(1) OJ L 359, 9.12.1992, p. 23.
(2) OJ L 204, 4.8.1999, p. 37.
(3) OJ L 294, 28.10.1997, p. 7.