2000/418/EC: Commission Decision of 29 June 2000 regulating the use of material presenting risks as regards transmissible spongiform encephalopathies and amending Decision 94/474/EC (notified under document number C(2000) 1735) (Text with EEA relevance)
Date: 2000-06-29
Institutions: European Commission
Subjects: United Kingdom, animal disease, animal product, cattle, health certificate, veterinary inspection

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II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 29 June 2000

regulating the use of material presenting risks as regards transmissible spongiform encephalo-
pathies and amending Decision 94/474/EC

(notified under document number C(2000) 1735)

(Text with EEA relevance)

(2000/418/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

described in 1996. Evidence is accumulating that the
agent causing BSE is identical to that causing v-CJD.

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 89/662/EEC of 11
December 1989 concerning veterinary checks
in infra-
Community trade with a view to the completion of the internal
market (1), as last amended by Directive 92/118/EEC (2), and in
particular Article 9(4) thereof,

(2)

Having regard to Council Directive 90/425/EEC of 26 June
1990 concerning veterinary and zootechnical checks applicable
in infra-Community trade in certain live animals and products
with a view to the completion of the internal market (3), as last
amended by Directive 92/118/EEC, and in particular Article
10(4) thereof,

Having regard to Council Directive 97/78/EC of 18 December
1997 laying down the principles governing the organisation of
veterinary checks on products entering the Community from
third countries (4), and in particular Article 22 thereof,

(3)

Whereas:

(1)

Several distinct
transmissible spongiform encephalo-
pathies (TSEs) have been recognised for many years as
occuring separately in humans and animals. Bovine
Spongiform Encephalopathy (BSE) was first recognised
in bovine animals in 1986 and in following years was
recognised as occurnng in other species of animals. A
new variant of Creutzfeldt-Jakob Disease (v-CJD) was

(1) OJ L 395, 30.12.1989, p. 13.
(2) OJ L 62, 15.3.1993, p. 49.
(3) OJ L 224, 18.8.1990, p. 29.
(4) OJ L 24, 30.1.1998, p. 9.

The Scientific Veterinary Committee in its opinion of 21
October 1996, recommended on the basis of its risk
assessment that specified risk materials, defined as brain,
spinal cord and eyes from cattle, sheep and goats over
one year of age and spleens from sheep and goats over
six months of age, should be removed from all human
food and animal feed chains in countries or regions
where a potential risk was identified.
It also recom-
mended that, in the case of fallen bovine animals, sheep
and goats, either the specified risk materials should be
removed so that they do not enter any human food or
animal
feed chain, or the whole carcass should be
destroyed.

The Scientific Steering Committee (SSC) adopted an
opinion on 9 December 1997. It suggested a new and
enlarged list of specified risk materials and proposed that
those materials should be excluded temporarily from
human and animal consumption depending on the
geographical source.
It added dura mater, pituitary,
dorsal root ganglia, vertebral column, intestine and lung
when animals are killed by certain slaughter techniques,
to the list recommended by the above opinion of the
Scientific Veterinary Committee of 21 October 1996.
The SSC adopted on 14 April 2000 an opinion on the
the ban on the
United Kingdom decision to lift
consumption of meat on the bone. It concluded that the
risk from meat on the bone is negligible if the bones are
not from the vertebral column or skull. It furthermore
concluded that the combined effect of several protection
measures in the United Kingdom results in an extremely

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small risk of human exposure to BSE from vertebral
column and dorsal
root ganglia. This Committee
adopted on the same date an opinion on specified risk
materials of small ruminants. It stated that skull (head
excluding skin and tongue) and spinal cord of all small
ruminants above 12 months and the spleen of small
ruminants of all ages pose the highest risk. It also stated
that
such as
mechanically recovered meat derived from the vertebral
column of small ruminants constitutes a significant
potential risk.

certain unprocessed meat products,

The Commission adopted on 18 November 1998 a
proposal based on Article 152(4) of
the Treaty
(COM(1998) 623 final) for a Regulation of the European
Parliament and of the Council laying down rules for the
prevention and control of certain transmissible spongi-
form encephalopathies (1). That proposal was submitted
to the European Parliament and the Council on 7
January 1999. That proposal
includes rules on the
removal and disposal of specified risk materials. The
provisions of this Decision will be repealed when that
Regulation enters into force.

feed or

for human food, animal

Rules should be laid down concerning the production
and placing on the market of products of animal origin
with respect to removal of, or absence of, specified risk
material. In particular, they should not be placed on the
fertiliser.
market
However, those rules should not apply to cosmetic or
medicinal products or medical devices, or their starting
materials or intermediate products,
for which other
specific rules apply. They should also not apply to prod-
ucts 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
outside the scope of this Decision are kept separate from
those within it unless they meet at least the same health
standards as the latter.

(8)

(9)

and the rules for sampling and laboratory testing for the
presence of a TSE. The Commission has undertaken to
amend Decision 98/272/EC with the objective to
improve the efficacy of
the monitoring for BSE in
bovine animals by use of tests targeting in particular
dead-onfarm (fallen stock) and emergency slaughtered
animals. These measures are expected to provide a better
insight into the regional epidemiological situation.

Certain ruminant tissues should be designated as speci-
fied risk materials on the basis of the pathogenesis of
TSEs and the epidemiological status of the country or
region of origin or residence of the animal concerned.
The specified risk materials should be removed and
disposed of in a manner that avoids any risk to human
or animal health. It is necessary for practical and precau-
tionary reasons to exclude the use of spleens from sheep
and goats irrespective of age, and mechanically recov-
ered meat from the skull and vertebral column of bovine
animals, sheep and goats.

The SSC and the Scientific Committee on Veterinary
Measures relating to Public Health recommended on the
safety of certain slaughter techniques in their opinions
adopted on 9 December 1997 and on 25 June 1999,
and on 17 February 1998 respectively. They concluded
that certain slaughter techniques, notably pneumatic
stunning by gas injection and laceration of central
nervous tissue by means of an elongated rod-shaped
instrument
introduced into cranial cavity (‘pithing’)
could cause the dissemination of potentially contami-
nated central nervous tissue throughout the body during
slaughter. Council Directive 93/119/EC of 22 December
1993 on the protection of animals at
the time of
slaughter or killing (3), prohibits the use of these tech-
niques for the stunning and killing of animals. Therefore,
the use of those techniques should not be permitted for
other purposes in the Community, and upon import
from countries or regions with a risk of BSE.

Existing Community Directives provide for the protec-
tion of public health in respect of the use of specified
in cosmetic or medicinal products and
risk material
medical
in the
devices placed on the market
Community. Therefore, those products may be excluded
from the scope of this Decision.

(10)

for

transmissible

Commission Decision 98/272/EC of 23 April 1998 on
epidemio-surveillance
spongiform
encephalopathies (2) lays down the rules for measures to
be taken by Member States where a transmissible spon-
giform encephalopathy (TSE) is suspected in an animal,
the minimum requirements
the monitoring of
bovine spongiform encephalopathy (BSE) and scrapie

for

The Commission will review the provisions to take into
account the effectiveness of the feed ban and the need to
remove vertebral column from certain cattle subpopula-
tions, as soon as possible in the light of new scientific
information and assessments, as well as the development
of the recommendations of the World Organisation for
Animal Health (Office International des Epizooties), or
any other relevant information available to the Commis-
sion. The review with respect to the effective enforce-
ment of the prohibition on the feeding of ruminants
with meat-and bone meal and greaves derived from
ruminants envisages confining the provisions of
this
Decision to animals born before the date of the effective-
ness of that ban.

(4)

(5)

(6)

(7)

(1) OJ C 45, 19.2.1999, p. 2.
(2) OJ L 122, 24.4.1998, p. 59.

(3) OJ L 340, 31.12.1993, p. 21.

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(11)

The SSC, in its opinion of 23 January 1998, has estab-
lished the list of factors determining the geographical
risk in a given geographical zone, and, in its opinion of
19 and 20 February 1998, the contents of a complete
dossier for epidemiological status with respect to TSEs.
On the basis of these opinions the Commission issued
Recommendation 98/477/EC (1) of 22 July 1998
concerning information necessary to support applica-
tions for the evaluation of the epidemiological status of
countries with respect
to transmissible spongiform
encephalopathies and inviting Member States and non-
member countries to submit dossiers according to this
recommendation for recognition of their epidemiolog-
ical status. The Commission will review the provisions
for the import of products of animal origin as soon as
possible in the light of scientific assessments using the
information submitted in accordance with Recommen-
dation 98/477/EC, as well as the development of the
recommendations of the World Organisation for Animal
Health (Office International des Epizooties). It therefore
repeats its invitation to submit a dossier in accordance
with that Recommendation for those countries that have
not yet done so and will make every effort to obtain a
scientific assessment within 12 months of the dossier
submission.

(12)

Commission Decision 94/474/EC of 27 July 1994
concerning certain protection measures
relating to
bovine spongiform encephalopathy and repealing Deci-
sions 89/469/EEC and 90/200/EEC (2), as last amended
by Decision 98/272/EEC, should be amended accord-
ingly.

(13) On the basis of the advice of the Scientific Veterinary
Committee of 21 October 1996, in accordance with the
risk assessment carried out by that Committee,
the
Commission adopted Decision 97/534/EC of 30 July
1997 on the prohibition of
the use of material
presenting risks as regards transmissible spongiform
encephalopathies (3), which was
amended by
Council Decision 1999/881/EC (4). In the light of the
new scientific advice, the development of international
standards and progress on the legislative process on
adopting primary legislation in this area, the definition
of specified risk materials laid down in Decision 97/534/
EC and the rules it lays down are no longer appropriate.
This Decision should therefore be repealed.

last

(14)

Separate rules may be adopted on the treatment and
disposal of animal by-products.

(15)

The Standing Veterinary Committee has not given an
opinion; the Commission has therefore proposed these
measures to the Council on 16.6.2000 in accordance

(1) OJ L 212, 30.7.1998, p. 58.
(2) OJ L 194, 29.7.1994, p. 96.
(3) OJ L 216, 8.8.1997, p. 95.
(4) OJ L 331, 23.12.1999, p. 78.

with Article 17 of Directive 89/662/EEC, the Council
being required to act within 15 days.

(16) However, the Council has not acted within the required
the
time limit;
proposed measures by simple majority within the same
time limit; these measures should now be adopted by
the Commission,

the Council has not decided against

HAS ADOPTED THIS DECISION:

Article 1

Scope

1.
This Decision regulates the use of material presenting
risks as regards certain transmissible spongiform encephalo-
pathies (TSEs). It shall apply to the production and placing on
the market of products of animal origin derived from or
containing material of the bovine, ovine or caprine animal
species.

2.

Articles 3 to 8 shall not apply to:

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

(b) products not destined for use in human food, animal feed
or fertilisers, together with their starting materials or inter-
mediate products;

(c) products of animal origin destined for exhibition, teaching,
research, special studies or analysis, provided those prod-
ucts are not eventually consumed by humans or by animals
other than those kept for the research projects concerned.

3.
In order to avoid cross-contamination or substitution,
products of animal origin referred to in Article 1(1) shall be
kept separate at all times from those referred to in Article 1(2),
unless the latter are handled or produced under at least the
same conditions of health protection in respect of TSEs.

Article 2

Definitions

For the purposes of this Decision, the following definitions
shall apply:

1.

2.

‘transmissible spongiform encephalopathies or TSEs’: all
TSEs with the exception of those occurring in humans;

‘placing on the market’: any operation the purpose of which
is to sell products of animal origin covered by this Decision
to a third party, or any other form of supply against
payment or free of charge to a third party, or storage with a
view to supply to a third party;

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3.

4.

5.

6.

7.

8.

‘products of animal origin’: any products derived from or
containing a product derived from any animal;

2.

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

‘fertilisers’: any substance containing products of animal
origin utilised on land to enhance growth of vegetation; it
may include digestion residues from bio-gas production or
composting;

‘competent authority’: the central authority of a Member
State competent to ensure compliance with the require-
ments of
this Decision or any authority to which that
central authority has delegated such competence;

‘specified risk material’: the tissues referred to in Annex I;
unless otherwise specified,
include products
containing or derived from those tissues;

it does not

‘landfill site’:
1999/31/EC (1).

landfill site as defined by Council Directive

(a) Where the products of animal origin listed in Annex II,
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:

‘The product of animal origin does not contain, and
is not derived from, specified risk material as defined
in Annex I, point 1(a) of Decision [.../...], produced
after 31 March 2001, or mechanically recovered
meat obtained from the bones of the head or verte-
bral 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.’

Article 3

Specified risk material

1. Member States shall ensure that after 1 October 2000 the
specified risk materials referred to in Annex I, point 1(a), and as
appropriate point 1(b), are removed and destroyed in accord-
ance with Annex I, points 2 to 5.

2.
The specified risk materials or the processed material
thereof may be dispatched only for arrangements of eventual
incineration in accordance with Annex I, point 5, and, as
appropriate, Article 7, paragraph (b).

Article 4

Mechanically recovered meat

Member States shall ensure that bones of the head and verte-
bral columns of bovine, ovine and caprine animals shall not be
used for the production of mechanically recovered meat after 1
October 2000.

Article 5

Slaughter techniques

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 after
31 December 2000 on their territory on bovine, ovine or
caprine animals whose meat is destined for human or animal
consumption.

Article 6

Import into the Community

(b) Any reference to ‘products of animal origin’

in this
Article is a reference to the products of animal origin
listed in Annex II, not to other products of animal
origin containing or derived from those products of
animal origin.

The provisions of paragraphs 1 and 2 shall only apply to

3.
import from third countries:

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

(b) which have submitted such a dossier but for which the
outcome of a risk assessment identifying all potential risk
factors is not satisfactory.

Article 7

Official controls

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
in accordance with Article 7 of Council
Member States
Directive 90/667/EEC (2), points of sale to the consumer, land-
fill sites and other facilities for storage or incineration. They
shall in particular set up a system to ensure and check that:

1.
The specified risk materials referred to in Annex I, point
1(a) shall not be imported into the Community after 31 March
2001.

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

(1) OJ L 182, 16.7.1999, p. 1.

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

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(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 separately and
are disposed of in accordance with Article 3 and Annex I.
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 condi-
tions to be applied to such movements.

Article 9

Amendments

Article 3(3) of Decision 94/474/EEC is hereby amended as
follows:

(a) point (a) is deleted;

(b) in point (c), ‘the implementation of (a) and (b)’ is replaced

by ‘the implementation of (b)’.

Article 8

Review

1.
This Decision shall be reviewed regularly in the light of
new scientific information with regard to the risk of exposure
to TSEs.

Article 10

Repeal

1.

Decision 97/534/EC is repealed on 30 June 2000.

References to Decision 97/534/EC shall be construed as

2.
references to this Decision.

Article 11

Application

This Decision shall be amended acting in accordance with

2.
the appropriate procedure:

This Decision shall apply from 30 June 2000.

(a) to take account of the dates of effective enforcement of the
prohibition on the feeding of mammalian, or as appro-
priate, ruminant protein to ruminants, in each country or
region thereof;

(b) to allow the use of vertebral column and dorsal root
ganglia from bovine animals in or coming from the United
Kingdom of Great Britain and Northern Ireland and
Portugal or regions thereof;

(c) to exempt certain third countries from the provisions of

Article 6, paragraphs 1 and 2.

Article 12

Addressees

This Decision is addressed to the Member States.

Done at Brussels, 29 June 2000.

For the Commission

David BYRNE

Member of the Commission

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ANNEX I

Specified risk material

1.

(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.

(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 six
months;

(ii) the vertebral column,

including dorsal root ganglia, of bovine animals aged over 30 months.

2. 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.

3. 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):

— by incineration;
— 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.

4. Member States may derogate from the provisions of points 2 and 3 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.

5. 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 Decision may be amended on request of a Member State to allow the dispatch of specified risk material or the
processed material thereof to third countries for incineration. The Commission shall at the same time adopt the
conditions governing the exportation.

(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.

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ANNEX II

The following products of animal origin shall be subject to restrictions on import into the Community pursuant to Article
6(1):

(a) ‘fresh meat’: fresh meat as defined by Council Directive 64/433/EEC (1) on health problems affecting intra-Community

trade in fresh meat;

(b) ‘minced meat’ and ‘meat preparations’: minced meat and meat preparations as defined by Council Directive 94/

65/EC (2);

(c) ‘meat products’: meat products as defined by Council Directive 77/99/EEC (3);

(d) ‘processed animal protein’, as referred to by Directive 92/118/EEC.

(1) OJ L 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.