98/256/EC: Council Decision of 16 March 1998 concerning emergency measures to protect against bovine spongiform encephalopathy, amending Decision 94/474/EC and repealing Decision 96/239/EC
Date: 1998-03-16
Institutions: Council of the European Union
Subjects: United Kingdom, animal disease, cattle, export restriction, health risk, veterinary inspection

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Official Journal of the European Communities

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II

(Acts whose publication is not obligatory)

COUNCIL

COUNCIL DECISION

of 16 March 1998

concerning emergency measures
encephalopathy,

spongiform
amending Decision 94/474/EC and repealing Decision

to protect against bovine

96/239/EC

(98/256/EC)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 90/425/EEC of
26 June 1990 concerning veterinary and zootechnical
checks applicable in intra-Community trade in certain
live animals and products with a view to the completion
of the internal market (1), and in particular Article 10(4)
thereof,

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

Having regard to the proposal from the Commission,

(1) Whereas new information has been published in the
United Kingdom further supporting the hypothesis
that exposure to the bovine spongiform encephalo-
pathy (BSE) agent is linked to the new variant of
Creutzfeldt Jacob Disease (CJD) in humans; whereas
on 16 September 1997 the Spongiform Encephal-
opathy Advisory Committee (SEAC) of the United
Kingdom concluded that recent research provided

(1) OJ L 224, 18. 8. 1990, p. 29. Directive as last amended by

Directive 92/118/EEC (OJ L 62, 15. 3. 1993, p. 49).

(2) OJ L 395, 30. 12. 1989, p. 13. Directive as last amended by

Directive 92/118/EEC.

the agent which
compelling new evidence that
causes BSE is identical to the agent which causes the
new variant of CJD in humans; whereas on
18 September 1997 the Advisory Committee on
Dangerous Pathogens (ACDP) concluded that
the
BSE agent should now be classified as a human
pathogen;

(2) Whereas, in those circumstances and as an emer-
gency measure, it is appropriate to prohibit tempor-
arily the dispatch to the other Member States of all
bovine animals from the United Kingdom and of all
products consisting entirely or in part of, or incorp-
orating materials derived from, bovine
animals
slaughtered in the United Kingdom which are liable
to enter the human food or animal feed chains or are
destined for use in cosmetic, pharmaceutical or
medical products; whereas in order to prevent deflec-
tions of
the same prohibitions should also
apply to exports to third countries;

trade,

(3) Whereas,

in order to protect animal and human
health in the Community, the Commission adopted
Decision 94/474/EC of 27 July 1994 concerning
certain protection measures relating to bovine spon-
giform encepahalopathy and repealing Decisions
89/469/EEC
Decision
92/290/EEC of 14 May 1992 concerning certain

90/200/EEC (3),

and

(3) OJ L 194, 29. 7. 1994, p. 96. Decision as last amended by

Decision 95/287/EC (OJ L 181, 1. 8. 1995, p.40).

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June

1994

protection measures relating to bovine embryos in
respect of bovine spongiform encephalopathy (BSE)
in the United Kingdom (1), Decision 94/381/EC of
27
certain protection
concerning
measures with regard to bovine spongiform encepha-
lopathy and the feeding of mammalian derived
protein (2) and Decision 96/449/EC of 18 July 1996
on the approval of alternative heat-treatment systems
for processing animal waste with a view to the inacti-
vation of spongiform encephalopathy agents (3);

(4) Whereas the United Kingdom has taken measures as
a result of the publication of information on certain
cases of CJD in that Member State;

(5) Whereas the United Kingdom has banned the use of
mammalian meat-and-bone meal, regardless of
its
origin, for feeding farm animals; whereas it is neces-
sary to provide that mammalian meat-and-bone meal
and farm animal
feed and fertilisers containing
mammalian meat-and-bone meal, which by their
nature could enter the farm animal feed chain, may
not be dispatched from the United Kingdom;

(6) Whereas the risk of transmissible spongiform ence-
phalopathies (TSEs) entering the human food or
animal
feed chains through the consumption of
protein derived from domestic carnivores is con-
sidered low; whereas that risk can be further reduced
by requiring that domestic carnivores are not fed
mammalian meat-and-bone meal originating in the
United Kingdom; whereas it is therefore appropriate
to provide that food for domestic carnivores which is
produced in the United Kingdom but contains
no mammalian meat-and-bone meal originating in
that country may be dispatched from its territory to
other Member States or to third countries;

(7) Whereas the United Kingdom has taken measures to

destroy certain bovine tissues;

(8) Whereas Commission Decision 96/239/EC of
27 March 1996 on emergency measures to protect
against bovine spongiform encephalopathy (4), before
its amendment by Decision 96/362/EC (5), prohibited
the dispatch from the United Kingdom to other

(1) OJ L 152, 4. 6. 1992, p. 37. Decision as amended by the 1994

Act of Accession.

(2) OJ L 172, 7. 7. 1994, p. 23. Decision as amended by Decision

95/60/EC (OJ L 55, 11. 3. 1995, p. 43).

(3) OJ L 184, 24. 7. 1996, p. 43.
(4) OJ L 78, 28. 3. 1996, p. 47.
(5) OJ L 139, 12. 6. 1996, p. 17.

Member States and to third countries, in particular,
of bovine semen, and certain other products from the
United Kingdom obtained from bovine animals
slaughtered in the United Kingdom which are liable
to enter the animal feed or human food chains and
materials destined for use in medicinal products,
cosmetics or pharmaceutical products;

(9) Whereas the Scientific Veterinary was consulted on
18 and 26 April 1996; whereas, in the opinion of that
Committee, bovine semen is considered to be safe
for animal health with respect to BSE;

(10) Whereas the Scientific Committee on Cosmetology
was consulted on the safety of certain bovine
products on 11 April 1996; whereas the Liaison
Committee of European Associations of the Perfume,
Cosmetic Products and Toiletries Industries (Colipa)
has recommended its members not to use source
materials from United Kingdom bovine animals;
whereas
its
recommendation; whereas
members
Commission Directive 97/1/EC of 10 January 1997
adapting to technical progress Annexes II, III, VI,
and VII to Council Directive 76/768/EEC on the
approximation of the laws of the Member States re-
lating to cosmetic products (6), has provisionally pro-
hibited the placing on the market of cosmetic
products containing certain tissues and fluids;

that Committee has declared that

follow that

(11) Whereas

food was
the Scientific Committee for
consulted on the safety of certain bovine products on
15 April 1996;

(12) Whereas the Committee for Proprietary Medicinal
Products was consulted on 16 April 1996; whereas
the pharmaceutical sector had already introduced
measures relating to the sourcing of materials and
their treatment; whereas every medicinal product
is
undergoes a pre-marketing approval before it
placed on the market by virtue of which the treat-
ment process of any raw material
is evaluated;
whereas at the request of the European Agency for
the Evaluation of Medicinal Products, all Community
marketing authorisation holders, or applicants with a
positive opinion from the Committee for Proprietary
Medicinal Products or the Committee for Veterinary
Medicinal Products, have
the
products concerned do not contain bovine tissue of
United Kingdom origin;

confirmed

that

(6) OJ L 16, 18. 1. 1997, p. 85.

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(13) Whereas subsequently, additional

information was
made available in order to facilitate a more complete
risk assessment; whereas, on that basis, the Scientific
Veterinary Committee on 26 April 1996 concluded
that a combination of appropriate sourcing of bovine
materials used and the application of minimum
processing standards whch have been shown effect-
ively to inactivate the BSE agent together give good
reassurances about the safety of those materials for
the
food or cosmetic use; whereas, consequently,
Scientific Veterinary Committee has recommended
safety parameters for the production of those ma-
terials which are therefore considered to be safe;

whereas, however, in order to regualarise the situ-
ation, pending further
scientific knowledge and
advice, it is appropriate to withdraw the possibility of
dispatch of gelatin made from raw materials from
bovine animals slaughtered in the United Kingdom
for human food, animal feed, cosmetics pharmaceu-
tical and medical purposes; whereas that is in con-
formity with the advice from the Multidisciplinary
Scientific Committee of 3 April 1997, according to
which no production can be considered safe if the
base material used for gelatin production is poten-
tially infectious;

(14) Whereas the Commission accordingly considered
that certain products, such as gelatin and tallow, were
safe;

(20) Whereas the United Kingdom should be permitted
to dispatch rom its territory gelatin and di-calcium
phosphate for technical purposes made from raw
from bovine animals slaughtered in the
material
United Kingdom, provided that it is suitably labelled;

(15) Whereas in 1988 the United Kingdom introduced a
for animals affected with BSE to be
requirement
completely destroyed; whereas the Council, at
its
meeting on 1, 2 and 3 April 1996, concluded that
bovine animals over the age of 30 months should not
enter the human food or animal feed chains or be
used for
cosmetic or pharmaceutical products;
whereas such animals should not be used as source
materials for certain bovine products;

(16) Whereas furthermore, certain bovine tissues should
not be used as source materials for those products;

(17) Whereas Decision 96/362/EC amended Decision
96/239/EC to exempt certain products,
such as
gelatin, tallow and bovine semen, from the prohibi-
tion;

(18) Whereas the Scientific Veterinary Committee at its
meeting on 17 July 1996 endorsed the report of the
sub-group for BSE of 26 June 1996, where it recom-
mended that
for gelatin es-
the risk assessment
tablished by the Scientific Veterinary Committee on
26 April 1996 be reappraised in the light of the
uncertainties as to the inactivation of the BSE agent,
due note being taken of the requirements of De-
cision 96/362/EC;

(21) Whereas

the United Kingdom should also be
permitted to disptach from its
territory gelatin
produced from raw material from bovine animals not
slaughtered in the United Kingdom; whereas the
United Kingdom has introduced a system of trace-
ability for such gelatine to ensure that the origin of
the raw material is identifiable; whereas the Com-
munity rules should be supplemented by formally
introducing a system of traceability; whereas such a
system should be introduced for other products
which are exempted from the overall ban; whereas a
system of labelling should also be introduced;

(22) Whereas it is necessary to provide that products from
bovine animals not
slaughtered in the United
Kingdom should come from approved establish-
ments under official veterinary control which have a
system in place to ensure traceability to the origin of
the raw materials; whereas, however, dispatch of
those products from the United Kingdom may take
place inmediately, without prior inspection by the
Commission;

is necessary to lay down appropriate
(23) Whereas it
guarantees
the dispatch from the United
for
Kingdom of certain products obtained from bovine
animals which were not slaughtered in the United
Kingdom;

(19) Whereas Decision 96/362/EC laid down certain
preconditions which had to be met before the
United Kingdom could dispatch from its territory
gelatin made from raw materials
from bovine
animals; whereas those preconditions have not beeen
fulfilled and such dispatch has not been authorised;

(24) Whereas a reliable system of controls throughout the
Community is a precondition for the smooth func-
tioning of the beef market; whereas it is clear from
the investigations by the Unit on Coordination of
Fraud Prevention (UCLAF) and the Food and Veter-

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inary Office of the Commission that there are de-
ficiencies in official controls on production of beef
in the United Kingdom for dispatch to other
Member States and third countries; whereas it
is,
therefore, necessary to reinforce the system of veteri-
nary checks in order to prevent fraud;

(25) Whereas

reinforced checks

should apply to all
commercial consignments of fresh meat of bovine
animals moving into, through or from the territory of
the United Kingdom; whereas it is appropriate to
require that all such consignments be sealed and
unsealed by the competent authority and accom-
panied by veterinary certificates and, in the case of
intra-Community trade, to require an official noti-
fication of the dispatch of a consignment by means
of the ANIMO system as referred to in Commission
Decision 91/398/EEC of 19 July 1991 on a compu-
terised
authorities
(ANIMO) (1), or by fax;

veterinary

network

linking

(26) Whereas the veterinary supervision of the processing
of meat derived from bovine animals slaughtered
elsewhere than in the United Kingdom should also
be reinforced;

(27) Whereas the United Kingdom put forward a first
proposal for an export certified herds scheme to the
the
Commission on 25 February 1997; whereas
Scientific Veterinary Committee concluded at
its
meeting of 11 June 1997 that that proposal was not
adequate; whereas the United Kingdom put forward
a modified proposal dated 1 July 1997; whereas the
Scientific Veterinary Committee issued an opinion
on that revised proposal on 17 September 1997
stating that
the major obstacle to approving the
the United
the entire territory of
scheme for
Kingdom was the lack of a comprehensive compu-
terised movement and tracing system and associated
database for live cattle in Great Britain but that an
adequate system did apear
in Northern
Ireland; whereas the Committee concluded further-
more that small modifications could be made to
minor aspects of the scheme at the request of the
competent Commission departments
to
comply with certification or control requirements;
whereas the Food and Veterinary Office conducted a
feasibility inspection in Northern Ireland from 3 to
7 November 1997; whereas the United Kingdom has
agreed to further improvements in line with the
inspection;
recommendations made following that
whereas, therefore, a partial lifting of the prohibition

in order

to exist

on the dispatch of products from bovine animals
slaughtered in Northern Ireland is appropriate;

(28) Whereas inspections carried out by the Commission
services have shown that the system of veterinary
checks
effective;
in Northern Ireland is more
whereas, therefore, a step-by-step approach is appro-
priate, starting with the lifting of the prohibitions on
the dispatch of products
from bovine animals
slaughtered, cut, processed and stored in establish-
ments exclusively used for products destined for
dispatch to other Member States and third countries,
located in Northern Ireland; whereas subsequent
steps will include the lifting of the prohibition on
the processing of eligible meat
from Northern
Ireland in Great Britain, under conditions which will
be laid down at a later stage: whereas the Commis-
immediately start investigating, with the
sion will
authorities of the United Kingdom, by what means
and under what conditions those restrictions may be
further relaxed;

(29) Whereas in order to prevent

fraud, meat derived
from bovine animals
slaughtered in the United
Kingdom should bear, in addition to the health mark
provided for in Article 3(1)(A)(e) of Council Directive
64/433/EEC of 26 June 1964 on health problems
affecting intra-Community trade in fresh meat (2), a
distinct mark which cannot be confused with the
Community health mark;

(30) Whereas most of

the provisions of Decision
94/474/EC are no longer in conformity with the
opinion of the Scientific Veterinary Committee of
17 September 1997 and should therefore be deleted;

(31) Whereas Decision 96/239/EC required the United
Kingdom to provide reports on the BSE situation
every two weeks; whereas that period has been found
to be too short; whereas it should be extended to one
month;

(32) Whereas the Commission should continue to carry
out Community inspections in the United Kingdom
to verify the application of the measures provided for
in this Decision;

(33) Whereas the foregoing entails a fundamental re-
in the
working of Decision 96/239/EC; whereas,
interests of clarity, that Decision should be repealed;

(34) Whereas this Decision will be reviewed in the light

of new scientific information;

(1) OJ L 221, 9. 8. 1991, p. 30.

(2) OJ 121, 29. 7. 1964, p. 2012/64. Directive as last amended by

Directive 95/23/EC (OJ L 243, 11. 10. 1995, p. 7).

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(35) Whereas the Standing Veterinary Committee has not

Article 4

given a favourable opinion,

HAS ADOPTED THIS DECISION:

CHAPTER I

Live bovine animals, bovine embryos, meat-and-
bone meal and related products

Article 1

the situation, and
Pending an overall examination of
notwithstanding Community provisions
to
adopted
protect against BSE, the United Kingdom shall ensure
that the following are not dispatched from its territory to
other Member States or to third countries:

(a) live bovine animals and bovine embryos;

(b) meat meal, bone meal, and meat-and-bone meal of

mammalian origin;

(c) animal feed and fertilisers containing material referred

to in (b).

Article 2

By way of derogation from Article 1, food destined for
domestic carnivores containing material referred to in
Article 1(b) may be dispatched to other Member States or
to third countries provided that those materials did not
originate from the United Kingdom and that the condi-
tions laid down in Articles 9 and 10 are complied with.

CHAPTER II

Materials derived from bovine animals slaughtered
in the United Kingdom

Article 3

the situation, and
Pending an overall examination of
notwithstanding Community provisions
to
adopted
protect against BSE, the United Kingdom shall ensure
that the following are not dispatched from its territory to
other Member States or to third countries, when derived
from bovine animals slaughtered in the United Kingdom:

(a) meat;

1.
By way of derogation from Article 3, the United
Kingdom may authorise the production and the dispatch
from its territory to other Member States or to third coun-
tries of:

(a) amino acids, peptides and tallow, which have been
produced in establishments under official veterinary
supervision which have been shown to be operating in
accordance with the conditions set out in Annex I;

(b) tallow products and products derived from tallow by
saponification, transesterification or hydrolysis, where
these are manufactured from tallow produced in ac-
cordance with this Article.

The United Kingdom shall ensure that the products
2.
referred to in paragraph 1 are labelled or otherwise iden-
tified to show the establishment of production and to in-
dicate that
they are suitable for use in human food,
animal
feed, cosmetics or medical or pharmaceutical
products.

3.
The United Kingdom shall ensure that products
referred to in paragraph 1(a) which are dispatched to other
Member States in accordance with this Article are accom-
panied by a health certificate issued by an official veteri-
narian stating that they conform to the conditions laid
down in this Decision and attesting to the frequency of
official controls carried out.

4.
Before an establishment may commence or recom-
mence the dispatch of products pursuant to this Article,
the United Kingdom shall forward to the Commission
and the other Member States the list of the establishments
referred to in paragraph 1(a), identifying for each estab-
lishment the purpose for which it has been approved. It
shall notify the Commission and the other Member States
immediately of any amendments to that list.

5.
Community inspections shall be carried out on the
implementation of official controls in respect of each of
the products
referred to in paragraph 1 before the
dispatch of those products may commence or recom-
mence.

after having

The Commission,

6.
consulted the
Member States in the framework of the Standing Vet-
erinary Committee, shall set the date on which estab-
lishments may commence or recommence dispatch of the
products referred to in paragraph 1(a).

Article 5

(b) products which are liable to enter the human food or

animal feed chains;

(c) materials which are destined for use in cosmetics or

medical or pharmaceutical products.

The United Kingdom shall ensure that gelatin, di-calcium
phosphate, collagen, tallow, tallow products and products
derived from tallow by saponification, transesterification
or hydrolysis which are produced for technical use from
raw materials derived from bovine animals slaughtered in

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the United Kingdom are labelled or otherwise identified
to show the establishment of production and their un-
suitability for use in human food, animal feed, cosmetics
or medical or pharmaceutical products.

Article 6

1.
By way of derogation from Article 3, the United
Kingdom may authorise the dispatch to other Member
States or to third countries of
the following products
derived from bovine animals born and reared in Northern
Ireland which have been slaughtered in Northern Ireland
in slaughterhouses exclusively used for that purpose, in
accordance with the conditions laid down in this Article,
Article 7, Articles 9 to 12 and Annex II:

(a)

‘fresh meat’ as defined by Directive 64/433/EEC;

(b) ‘minced meat’ and ‘meat preparations’ as defined by

Directive 94/65/EC (1);

(c) ‘meat products’ as defined by Directive 77/99/EEC (2).

tissues,

The fresh meat referred to in paragraph 1(a) shall be
2.
deboned and all adherent
including obvious
nervous and lyphatic tissues shall be removed in cutting
plants in Northern Ireland, exclusively used for eligible
products. Cold storage shall
take place in Northern
Ireland in chambers exclusively used for eligible products.
Cutting, storage and transport shall be carried out
in
accordance with the conditions laid down in this Article,
Article 7, Articles 9 to 12 and Annex II.

The fresh meat referred to in paragraph 1(a) may be
3.
used for the production of products referred to in para-
graph 1(b) and (c) in establishments in Northern Ireland
exclusively used for eligible products, in accordance with
the conditions laid down in this Article,
in Article 7,
Articles 9 to 12 and Annex II.

4.
For the purposes of this Article, eligible products
means products referred to in paragraph 1 and products
derived from bovine animals not slaughtered in the
United Kingdom which comply with the conditions laid
down in Articles 9 to 13.

5.
The Commission, after having carried out Com-
munity inspections and after having informed the Mem-
ber States, shall set the date on which dispatch of the
products referred to in paragraph 1 may commence.

6.
The Commission shall review the provisions of this
Article at least every three months and shall take appro-
priate measures in accordance with the procedure laid
down in Article 18 of Directive 89/662/EEC.

Article 7

1.
The meat and products referred to in Article 6(1)
shall be marked or labelled with an additional distinct
mark which cannot be confused with the Community
health mark.

(1) OJ L 368, 31. 12. 1994, p. 10.
(2) OJ L 26, 31. 1. 1977, p. 85.

2. Meat and products as referred to in Article 6(1)
which are destined for placing on the market in the
United Kingdom shall not bear the additional mark
referred to in paragraph 1 of this Article. Where such a
mark is present, it shall be cancelled or removed from the
meat or cancelled from the label at the time that meat or
those products leave the establishment. The Community
health mark shall not be removed except where that is
unavoidable in the cutting process.

3.
The United Kingdom shall forward to the Commis-
sion and the other Member States the model of the addi-
tional mark referred to in paragraph 1 before dispatch
commences.

CHAPTER III

Materials derived from bovine animals not slaught-
ered in the United Kingdom

Article 8

The United Kingdom shall ensure that the provisions of
Articles 9 to 13 are complied with when the following
products derived from bovine animals not slaughtered in
the United Kingdom are dispatched from its territory to
other Member States or to third countries:

(a)

‘fresh meat’ as defined by Directive 64/433/EEC;

(b) ‘minced meat’ and ‘meat preparations’ as defined by

Directive 94/65/EC;

(c)

‘meat products’ and ‘other products of animal origin’
as defined by Directive 77/99/EEC;

(d) food which is destined for domestic carnivores;

tallow,

(e) gelatin and di-calcium phosphate,

tallow
products, and products derived from tallow by saponi-
fication, transesterification or hydrolysis, amino acids,
peptides and collagen which are liable to enter the
human food or animal feed chains, or are destined for
use
in cosmetics or medical or pharmaceutical
products.

Article 9

1.
The products referred to in Article 8 shall come
from and, as appropriate, have passed through, establish-
ments in the United Kingdom:

(a) which have been approved by the comptetent au-

thority;

(b) which are under official veterinary supervision or, in
the case of products derived from tallow by saponifica-
tion, transesterification or hydrolysis, under the super-
vision of the competent authority;

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15. 4. 98

(c) which have put in place a system of tracing the raw
material which will guarantee the origin of the ma-
terial throughout the whole production chain;

(d) which have put

in place a registration system of
amounts of incoming and outgoing materials to allow
for cross-checking consignments entering or leaving;

(e) in which the products are unloaded, processed, stored,
handled, loaded and transported separately from, or at
different times from, products which do not comply
with the conditions laid down in this Article and
Articles 10, 11 and 12.

2.
The United Kingdom shall forward to the Commis-
sion and the other Member States the list of establish-
ments which meet the conditions referred to in paragraph
1,
the purpose for
which it has been approved. It shall notify the Commis-
sion and the Member States immediately of any amend-
ments to that list.

identifying for each establishment

Article 10

1.
Products referred to in Article 8(a) to (d) shall come
from and, as appropriate, have passed through estab-
lishments in the United Kingdom in which:

(a) all unloading, processing, storage or other handling
and loading of products takes place under official
supervision;

(b) the products are stored in cold stores in chambers
which are not used at the same time for storing any
bovine products which do not comply with the condi-
tions laid down in this Article, in Articles 9, 11, 12
and 13 and are kept locked under the seal of the
competent authority when the latter is not present;

(c) the products, with the exception of

the products
referred to in Article 8(d), are marked or labelled with
an additional distinct mark which cannot be confused
with the Community health mark;

(d) the products eligible for dispatch from the United
Kingdom within the meaning of
this Article and
Articles 9, 11, 12 and 13, but destined for placing on
the market in the United Kingdom do not bear the
additional mark referred to in point (c). Where such a
mark is present, it shall be cancelled or removed from
the meat or cancelled from the label at the time that
meat or those products leave the establishment.

2.
For the purposes of the health marking and applica-
tion of additional marks provided for in Community
legislation, the competent authority shall keep and main-
tain under its responsibility:

(a) the instruments intended for meat health marking and
application of additional marks, which may be handed
over to auxiliaries only at time of marking and for the
length of time required for that purpose;

(b) any labels bearing a health mark or an additional
mark. Those labels shall be serially numbered and the
requisite quantity may be given to auxiliaries at the
time when they are to be used.

3.
The products referred to in paragraph 1 shall be
transported by means of transport that are sealed by the
competent authority.

When those products are dispatched to other Member
States, they shall be accompanied by a health certificate
issued by an official veterinarian stating that the condi-
tions referred to in this Article and Articles 9, 11, 12 and
13 are met, identifying all establishments where they were
obtained, processed, handled or stored and identifying all
labels and their serial numbers in the consignment.

Meat shall be accompanied by the health certificate
referred to in Annex IV to Directive 64/433/EEC identi-
fying in the ‘Identification of Meat’ section of the certi-
ficate all labels and their serial numbers in the consign-
ment.

The following words shall be added to all certificates:

‘produced in accordance with Decision 98/256/EC’.

4.
The United Kingdom shall inform the competent
authority of the place of destination of each consignment
by means of the Animo system or by fax.

Article 11

Without prejudice to Article 7(2) and Article 10(1)(d),
where products referred to in Article 8(a) come from and,
as appropriate, have passed through establishments in the
United Kingdom, the Community health marks shall not
be removed except where that
is unavoidable in the
cutting process.

Article 12

The United Kingdom shall forward to the Commission
and the other Member States the model of the additional
mark.

referred to in Article 8(e) which are
The products
dispatched to other Member States shall be labelled in
order to identify the establishment of production and to
indicate that they have been produced in accordance with

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this Decision and, as appropriate, that they are suitable for
use in human food, animal feed, cosmetics or medical or
pharmaceutical products.

Article 13

1.
A Member State which dispatches meat as referred
to in Article 8(a) from an establishment or Community
approved border inspection post in its territory through
the territory of the United Kingdom or to an establish-
ment approved in accordance with Article 9 shall ensure
that the meat is accompanied by a veterinary certificate
issued by an official veterinarian or the certificate issued
by the competent authority of the border inspection post.

The originals of all certificates shall accompany the
consignment to the establishment of its destination.

The meat as referred to in Article 8(a) shall be trans-

2.
ported in an officially sealed vehicle.

The seal may be broken only for official
purposes.

inspection

3.
A Member State which dispatches products referred
to in Article 8(e) or any raw materials for use in the
production of
to an establishment
approved in accordance with Article 9 shall ensure that
they are labelled or otherwise identified to show the es-
tablishment and Member State in which they were
produced.

those products

CHAPTER IV

Final provisions

Article 14

Article 15

The United Kingdom shall send the Commission every
month a report on the application of
the protective
measures taken against BSE, in accordance with national
and Community provisions.

Article 16

This Decision shall be reviewed regularly in the light of
new scientific information. This Decision shall be
amended, where appropriate, after consultation of
the
appropriate Scientific Committee, in accordance with the
procedure
of Directive
89/662/EEC.

laid down in Article

18

Article 17

Member States shall adopt
comply with this Decision. They shall
inform the Commission thereof.

the necessary measures to
immediately

Article 18

Decision 94/474/EC is hereby amended as follows:

1. Article 1 shall be deleted;

2. in Article 3, paragraphs 1 and 2 shall be deleted;

3. Article 4 shall be deleted.

Article 19

Decision 96/239/EC is hereby repealed.

Article 20

This Decision is addressed to the Member States.

Done at Brussels, 16 March 1998.

The Commission shall carry out Community inspections
on-the-spot in the United Kingdom to verify the applica-
tion of the provisions of this Decision, in particular in
relation to the implementation of official controls.

For the Council

The President

J. CUNNINGHAM

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ANNEX I

CHAPTER 1

1. The following products may be exported from the United Kingdom by virtue of Articles 4 to 7:

(a) amino acids and peptides produced from hides and skins by a process which involves exposure of the
material to a pH of 1 to 2, followed by a pH of ;11, followed by heat treatment at 140 HC for 30
minutes at 3 bar;

(b) tallow and tallow products produced from material from animals fit for human consumption which

has been subjected to one of the processes described in Chapter 2;

(c) products derived from tallow by one of the processes described in Chapter 3.

2. Products referred to in point 1 must be filtered after production.

3. Bovine animals which are showing signs of BSE and animals over 30 months of age may not be used as
source materials (as provided for by Commission Regulation (EC) No 716/96) (1) for production of the
products referred to in point 1.

4. The following tissues may not be used for production of products referred to in point 1: skull, vertebral

column, brain, spinal cord, eye, tonsil, thymus, intestine or spleen.

CHAPTER 2

A. Production standards for tallow produced in the United Kingdom from material derived from

bovine animals slaughtered in the United Kingdom

1. Tallow may be produced only in systems described in Chapters I to IV, VI and VII of the Annex to
Commission Decision 92/562/EEC (2), in which the following minimum conditions are achieved:

CHAPTER I

(Batch/atmospheric/natural fat)
150 mm particle size maximum

CHAPTER II

Temperature
Time

; 100 HC ; 110 HC ; 120 HC
120 min
125 min

50 min

(Batch/pressure/natural fat)
50 mm particle size maximum

; 100 HC ; 133 HC
Temperature
25 min
Time
Pressure (absolute) 3 bar

20 min

CHAPTER III

(Continuous/atmospheric/natural fat)
30 mm particle size maximum

Temperature
Time

; 100 HC ; 110 HC ; 120 HC
55 min
95 min

13 min

CHAPTER IV and VI

(Continuous/atmospheric/added fat and continuous/pressure/added
fat)
30 mm particle size maximum

Temperature
Time

; 100 HC ; 110 HC ; 120 HC ; 130 HC
16 min

13 min

8 min

3 min

CHAPTER VII

(Continuous/atmospheric/defatted)
20 mm particle size maximum

Temperature
Time

; 80 HC ; 100 HC
120 min

60 min

The above temperature/time requirements may run concurrently.

(1) OJ L 99, 20. 4. 1996, p. 14.
(2) OJ L 359, 9. 12. 1992, p. 23.

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2. The United Kingdom may authorise plants only if they have been shown by methods laid down in

Section B to be operating in accordance with the conditions set out in point 1.

3. Batch systems which achieve the parameters laid down in point 2 for continuous systems operating in

accordance with Chapters III, IV, VI or VII may also be authorised.

B. Procedures for the validation of plants for the processing of animal waste of ruminant origin
for the production of tallow in the United Kingdom, using methods described in the Annex to
Decision 92/562/EEC

1. Temperature — continuous and batch systems

Temperature monitoring devices must be situated regularly throughout the equipment in order to
record temperature at different stages in the process. Records should be kept and calibrations
completed at regular intervals.

2. Pressure (Chapter II only)

Pressure monitoring devices must be installed in order to record pressure at stages in the process.
Records must be kept and calibrations completed at regular intervals.

3. Particle size — all systems

CHAPTER 3

Human food, animal feed, medical or pharmaceutical products, their starting materials or inter-
mediate products

Tallow derivatives may be used provided that they are produced by an appropriate, validated and strictly
certified method such as:

1.

2.

transesterification or hydrolysis at not less than 200 HC for not less than 20 minutes under pressure
(glycerol, fatty acids and fatty acid esters production); or,

saponification with NaOH 12M (glycerol and soap production):
— in a batch process: at not less than 95 HC for not less than three hours; or,
— in a continuous process: at not less than 140 HC, 2 bars for not less than eight minutes, or equivalent.

Cosmetic products, starting materials or intermediate products

Tallow derivatives may be used provided that the following methods have been used and strictly certified by
the producer:

1.

2.

transesterification or hydrolysis at at least 200 HC, 40 bars for 20 minutes (glycerol and fatty acids and
esters); or,

saponification with NaOH 12M (glycerol and soap):
— in a batch process: at 95 HC for three hours; or,
— in a continuous process: at 140 HC, 2 bars for eight minutes or equivalent.

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ANNEX II

1. Deboned fresh meat and products referred to in Article 6(1)(b) and (c) from that meat derived from
bovine animals slaughtered in Northern Ireland may be dispatched from Northern Ireland in applica-
tion of the provisions of Article 6 when obtained from eligible animals which originate from eligible
herds.

Eligible herds

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

3. A herd is eligible when for at least 8 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.

4. As an exception to the provisions in point 2, a herd that has been in existence for less than eight years
may be considered eligible, after a thorough epidemiological investigation by the competent veterinary
authority, on condition that:

(a) all animals born or moved into the newly established herd complied with the conditions set out in

point 6(a),

(c),

(d) and (e); and,

(b) the herd has complied with the conditions set out in point 3 during its entire existence.

5. 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 epidemiological investigation by the competent veterinary authority,
taking into account compliance with each of the following conditions to the satisfaction of the com-
petent veterinary authority:

(a) all animals of the affected herd have been removed or killed;

(b) all feed has been removed and destroyed and all feed containers thoroughly cleansed;

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

(d) all conditions set out in point 4 have been complied with.

Eligible animals

6. A bovine animal is eligible if it has been born and reared in Northern Ireland and at the time of

slaughter:

(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.

7. The official computerised tracing system referred to in point 6(a) will be accepted only where it has been
in operation for sufficient time to contain all the information relating to the lifetime and movements of
the animals needed to check compliance with the requirements of this Decision, and only in respect of
animals born after the system came into operation. Historical data loaded into a computer for any period
before the system was operational will not be accepted for this purpose.

Controls

8. If animal presented for slaughter or any circumstance surrounding its slaughter does not meet all of the
requirements of this Decision, the animal must be automatically rejected. If that information becomes
available after slaughter, the competent authority must immediately cease issuing certificates, and cancel
issued certificates. If dispatch has already taken place, the competent authority must notify the com-
petent authority of the place of destination. The competent authority of the place of destination must
take the appropriate measures.

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9. Slaughter of eligible animals must take place in slaughterhouses exclusively used for that purpose.
Cutting, deboning and processing must place in establishments exclusively used for products which are
eligible for dispatch to other Member States or third countries. Cold storage must take place in cham-
bers, exclusively used for products which are eligible for dispatch to other Member States or third coun-
tries. All establishments through which the products pass before such dispatch must be situated in
Northern Ireland.

10. The competent authority must ensure that procedures used in the cutting plants ensure that the fol-

lowing lymph nodes have been removed:

— popliteal, ischiatic, superficial inguinal, deep inguinal, medial and lateral iliac, renal prefemoral,

lumbar, costocervical, sternal, prescapular, axilliary and caudal deep cervical.

11. Meat must be traceable back to the herd of the eligible animal by means of the computerised tracing
system until the time of slaughter. After slaughter, labels must be capable of tracing fresh meat and
products referred to in Article 6(1)(b) and (c) back to the herd to enable the consignment concerned to
be recalled.

12. All approved eligible carcases must have individual numbers correlated with the ear tag number.

13. The United Kingdom must have detailed protocols in place covering:

(a) tracing and controls prior to slaughter;

(b) controls during slaughter;

(c) all labelling and certification requirements after slaughter to the point of sale.

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

be demonstrated.

The establishment

15. To obtain approval, the establishment must, in addition to all other requirements of this Decision, devise
and implement a system whereby the eligible meat and/or eligible product is identifiable and all meat or
products can be traced back to its herds of origin. The system must facilitate full traceability of the meat
of products 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 au-
thority.

16. 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.