Proposal for a Council Regulation laying down transitional measures to permit the change-over to the Regulation of the European Parliament and of the Council (EC) 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, and amending Annexes VII and XI of that Regulation
Date: 2001-06-15
Institutions: European Commission
Subjects: EU law, animal disease, animal nutrition, bovine spongiform encephalopathy, disease prevention, foodstuffs legislation, marketing restriction, veterinary inspection

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 15.06.2001
COM(2001) 345 final

Proposal for a

COUNCIL REGULATION

laying down transitional measures to permit the change-over to the Regulation of the
European Parliament and of the Council (EC) 999/2001 laying down rules for the
prevention, control and eradication of certain transmissible spongiform
encephalopathies, and amending Annexes VII and XI of that Regulation

(presented by the Commission)

EXPLANATORY MEMORANDUM

Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down
rules for
the prevention, control and eradication of certain transmissible spongiform
encephalopathies (‘TSE Regulation’) was adopted on 22 May and published on 31 May 2001.
It entered into force on the day following its publication and will be applicable as of 1 July
2001.

The TSE Regulation provides a single text targeting all animal and public health risks
resulting from all animal TSEs, and governing the entire chain of production and placing on
the market of live animals and products of animal origin. It consolidates much of the existing
legislation on BSE or TSEs, including prohibitions concerning animal feeding, and introduces
new legislation for areas which are not yet covered by European Union (EU) rules such as
eradication of TSEs and rules with respect to TSEs for the placing on the market covering the
domestic market,
the
procedure, criteria and categories for the classification of countries according to BSE status.
Transitional measures may be adopted for a maximum period of 2 years.

import and export. It also provides for

intra-community trade,

Its provisions relating to the feed ban, specified risk material (SRM), further protective
measures for the use of ruminant material (notably gelatine and tallow), placing on the
market, import and export, are based on BSE classification. Article 5 of the Regulation lays
down the procedure and criteria necessary to carry out the evaluation of a BSE status and
specifies that a decision (Comitology) placing each applicant in a category has to be taken
after the necessary evaluation. To date no such decisions have been taken. Appropriate
transitional measures shall
therefore be adopted for the application of the concerned
provisions.

Transitional measures for SRM have already been agreed by Council and Parliament and are
foreseen by Article 22 and Annex XI of the Regulation. In the interest of clarity a similar
approach for the change-over from the current to the new regime should be used for the other
provisions based on classification. These transitional measures foresee that the existing
Community legislation remains in force until a formal decision has been taken placing the
country in question in a particular category. After that moment the provisions on specified
risk material laid down in the Regulation enter into force.

In addition, the need for transitional measures for the feed ban follows also from the
Conclusions of the Agricultural Council of 24 April 2001 to extend the suspension of the use
of processed animal protein in animal feed. In line with progress made on the collateral
proposal for a Regulation on Animal by-products this suspension should remain in force as
long as the prohibition on feeding mammalian protein to ruminants has not been effectively
enforced.

Furthermore, amendments to certain provisions of the Regulation are needed following
developments since the adoption of the Council Common Position in February 2001. These
relate to updating the SRM transitional measures and the BSE eradication measures.

Finally, it is proposed to delete those Decisions that are now overtaken by the Regulation.

In view of the urgency of the matter the Regulation should enter into force the day after
publication and take effect on 1 July. However,
in order to respect our international
obligations under the WTO SPS Agreement, in particular the notification procedures the
provisions relating to import shall not enter into force before 1 October 2001.

2

The proposal was presented to the Standing Veterinary Committee for an opinion on 13 June
2001. The results of the vote were:

In favour:

B, DK, EL, IRL, I, L, NL, P, FIN and S

Against:

D, E, F and A

Abstain:

UK

The Commission, not having received a favourable opinion from the Standing Veterinary
Committee, is required under Article 24 of Regulation (EC) 999/2001 to submit a proposal to
the Council without delay.

3

Proposal for a

COUNCIL REGULATION

laying down transitional measures to permit the change-over to the Regulation of the
European Parliament and of the Council (EC) 999/2001 laying down rules for the
prevention, control and eradication of certain transmissible spongiform
encephalopathies, and amending Annexes VII and XI of that Regulation

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) 999/2001 of the European Parliament and of the Council of
22 May 2001 laying down rules for the prevention, control and eradication of certain
transmissible spongiform encephalopathies1, and in particular Article 23 thereof,

Having regard to the proposal of the Commission,

Whereas:

(1)

(2)

Articles 7, 9 and 15 to 18 of Regulation (EC) 999/2001 lay down rules concerning
animal feeding, and impose further restrictions for products of ruminant origin and
marketing of live animals and products of animal origin. Their requirements vary
depending on the classification of the BSE status of the Member States or third
countries concerned. The classification for the determination of BSE status is to be
decided according to the criteria laid down in Article 5 of Regulation 999/2001. To
date no decisions have been taken to place any Member State or third country in a
category based on the new provisions under article 5. The provisions of the Regulation
would take effect in their entirety from 1 July 2001, unless transitional measures have
been adopted on the basis of Article 23. In absence of decisions on classification
Articles 7, 9 and 15 to 18 can not be applied: transitional measures are therefore
necessary.

Transitional measures for certain rules based on classification, namely those
concerning specified risk material, are already foreseen by Article 22, which provides
that they shall apply at least until 1 January 2002 and shall cease to apply immediately
following the date of adoption of a decision on classification in accordance with
Article 5, on which date Article 8, concerning specified risk material, shall apply. In
the interest of clarity the same rules for the change-over from the transitional rules to
the rules of the Regulation should apply to the other Articles based on classification.

1

OJ L 147, 31.5.2001, p. 1.

4

(3)

(4)

rules

feeding,

in force

transmissible

immediately prior

spongiform encephalopathy-related Community

on
The
prohibitions concerning animal
to the
implementation of Regulation (EC) 999/2001, are laid down in Council Decision
2000/766/EC concerning certain protection measures with regard to transmissible
spongiform encephalopathies and the feeding of animal protein2 and Commission
Decision 2001/9/EC concerning control measures required for the implementation of
Council Decision 2000/766/EC3. Decision 2000/766 suspends the feeding, with few
exceptions, of processed animal proteins to all farmed animals until 30 June 2001. The
Council concluded on 24 April 2001 that the period of application of the Decision
should be extended. This latter Decision shall therefore be amended accordingly as a
transitional measure. Any further amendments will depend on a decision on the
classification of Member States as well as the efficacy of control measures put in place
by individual Member States.

The transmissible spongiform encephalopathy related Community rules on placing on
the market and export of live bovine animals and of certain products of bovine animal
origin, in force immediately prior to the implementation of Regulation (EC) 999/2001,
are laid down in, or have been adopted pursuant to, Commission Decision 92/290/EEC
of 14 May 1992 concerning certain protection measures relating to bovine embryos in
respect of bovine spongiform encephalopathy (BSE) in the United Kingdom4, Council
Decision 98/256/EC of 16 March concerning emergency measures to protect against
bovine spongiform encephalopathy, amending 94/474/EC and repealing Decision
96/239/EC5, Commission Decision 98/351/EC of 29 May 1998 setting the date on
which dispatch from Northern Ireland of bovine products under the Export Certified
Herds Scheme may commence by virtue of Article 6(5) of Council Decision
98/256/EC6, Commission Decision 1999/514/EC of 23 July 1999 setting the date on
which dispatch from the United Kingdom of bovine products under the date-based
export scheme may commence by virtue of Article 6(5) of Council Decision
98/256/EC7, Commission Decision 2000/345/EC of 22 May 2000 setting the date on
which dispatch from Portugal to Germany of certain products for the purpose of
incineration may commence by virtue of Article 3(6) of Decision 98/653/EC8,
Commission Decision 2000/371/EC of 6 June 2000 setting the date on which dispatch
of fighting bulls from Portugal to France may commence by virtue of Article 3(7) of
Decision 98/653/EC9, Commission Decision 2000/372/EC of 6 June 2000 setting the
date on which dispatch of fighting bulls from Portugal to Spain may commence by
virtue of Article 3(7) of Decision 98/653/EC10
and Commission Decision
2001/376/EC of 18 April 2001 concerning measures made necessary by the
occurrence of bovine spongiform encephalopathy in Portugal and implementing a
date-based export scheme11. These Decisions shall therefore remain in force during the
transitional period.

2

3

4

5

6

7

8

9

10

11

OJ L 306, 7.12.2000, p. 32.
OJ L 2, 5.1.2001, p. 32.
OJ L 152, 4.6.1992, p. 37.
OJ L 113, 15.4.1998, p. 32.
OJ L 157, 30.5.1998, p. 110.
OJ L 195, 28.7.1999, p. 42.
OJ L 121, 23.5.2000, p. 9.
OJ L 134, 7.6.2000, p. 34.
OJ L 134, 7.6.2000, p. 35.
OJ L 132, 15.5.2001, p. 17.

5

(5)

(6)

(7)

The transmissible spongiform encephalopathy related Community rules on specified
risk material, in force immediately prior to the implementation of Regulation (EC)
999/2001, are laid down in, or have been adopted pursuant to, Commission Decision
2000/418/EC of 29 June 2000 regulating the use of material presenting risks as regards
transmissible spongiform encephalopathies and amending Decision 94/474/EC12. This
Decision has been amended with respect to bovine vertebral column, mechanically
recovered meat and the import from third countries, after the adoption by the Council,
on 12 February 2001, of its Common Position (EC) No 8/2001 with a view to adopting
Regulation (EC) 999/2001 of the European Parliament and the Council laying down
rules for the prevention, control and eradication of certain transmissible spongiform
encephalopathies13. Annex XI to that Regulation sets out the rules on specified risk
material which apply during the transitional period. Section A of that Annex should
therefore be updated to include the specified risk material provisions adopted since the
adoption by Council of its Common Position.

is appropriate to provide that

Until classification decisions have been made for third countries, and as a precaution,
the minimal protection measures foreseen by
it
Regulation (EC) 999/2001 for imports from all
third countries which are not
considered BSE free should apply to all imports of live bovine animals, embryos and
ova. Furthermore, the removal of specified risk material from products destined for
food and feed is the single most important public health protection measure. It is
therefore appropriate to extend, as a transitional measure, the list of products covered
by restrictions on import pursuant to Decision 2000/418/EC, to include all products
containing bovine, ovine or caprine material covered by Community Health
certificates. However, those third countries that benefit from a derogation for Decision
2000/418/EC should also benefit from a derogation from this transitional measures. In
the World Trade Organisation
order
Agreement on the Application of Sanitary and Phytosanitary Measures, in particular
the notification procedures, the provisions relating to import should not apply until
1 October 2001.

international obligations under

to respect

Annex VII to Regulation (EC) 999/2001 sets out the detailed rules for the measures to
be implemented following confirmation of the presence of a TSE. These rules should
be updated to reflect the detailed technical eradication provisions applied by the
Member States, taking into account the opinion of the Scientific Steering Committee
(SSC) on BSE related culling in cattle of 15 September 2000. The SSC concluded in
this opinion that 'already (entire) herd culling is having some effect both in terms of
eliminating otherwise not identified cases and in terms of preventing future cases to
appear. However,… largely the same effect can be reached by culling all animals born
and/or raised in the same herds as the confirmed case within approximately 12 months
before and after the date of birth of the index case (birth-cohort culling).' The SSC
recommended the culling of at least the birth-cohort whenever a domestic BSE case
appears,
is therefore
appropriate to amend the detailed eradication provisions accordingly by making the
culling of the entire herd optional depending upon the prevailing local situation.

irrespective of the prevailing epidemiological situation.

It

12

13

OJ L 158, 30.6.2000, p. 76.
OJ C 88, 19.3.2001, p. 1.

6

(8)

In the interest of clarity Commission Decision 94/474/EC of 27 July 1994 concerning
certain protection measures relating to bovine spongiform encephalopathy and
repealing Decisions 89/469/EEC and 90/200/EEC14, Commission Decision 94/381/EC
of 27 June 1994 concerning certain protection measures with regard to bovine
spongiform encephalopathy and the feeding of mammalian derived protein15, and
Commission Decision 2000/418/EC of 29 June 2000 regulating the use of material
presenting risks as regards transmissible spongiform encephalopathies and amending
Decision 94/474/EC, should be repealed

(9)

The Standing Veterinary Committee has not given a favourable opinion,

HAS ADOPTED THIS REGULATION:

By way of transitional measure derogating from Regulation (EC) 999/2001,

Article 1

1.

2.

1.

2.

the provisions of Regulation 999/2001 listed in Annex I to this Regulation shall not
apply to a Member State or third country until the entry into force of the decision
determining the BSE status of that Member State or third country, adopted pursuant
to Article 5 of Regulation 999/2001. Annex XI part D shall apply to the Member
State or third country concerned until that date. No such decision shall enter into
force before 1 January 2002;

Article 7(2), (3) and (4) shall not apply to a Member State until the coming into force
of the decision determining the BSE status of that Member State, and until the
Community provisions on animal feeding relevant
to transmissible spongiform
encephalopathies are effectively enforced there. Annex XI part C shall apply to that
Member State until Article 7(2), (3) and (4) become applicable there.

Article 2

In Article 4 of Decision 2000/766/EC, the second and third paragraphs, are hereby
deleted.

Decisions 94/381/EC, 94/474/EC and 2000/418/EC are repealed.

Regulation (EC) 999/2001 is amended as follows:

Article 3

1.

2.

3.

14

15

The text in Annex VII is replaced by the text in Annex II to this Regulation.

The text in Annex XI (A) is replaced by the text in Annex III to this Regulation.

The text in Annex XI is completed with the text in Annex IV to this Regulation.

OJ L 194, 29.7.1994, p. 96.
OJ L 172, 7.7.1994, p. 23.

7

Article 4

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

It shall apply from 1 July 2001.

However, the provisions of Annex XI, Section A, point 5 fourth to seventh, ninth and tenth
indent, and Section D point 2 and 3 to Regulation (EC) 999/2001, as modified by the present
Regulation, shall apply from 1 October 2001.

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

Done at Brussels,

For the Council
The President

8

–

–

–

–

–

–

–

–

ANNEX I

Article 9 concerning certain products of ruminant animal origin;

Article 15 (1) concerning the placing on the market of live animals, their semen,
embryos and ova;

Article 16 (2), (3), (4) and (6) concerning the placing on the market of products of
animal origin;

Article 17 concerning the health certificates or commercial documents relating to
trade;

Article 18 concerning the health certificates relating to imports;

Annex VIII, Chapter A (II) concerning the placing on the market of live bovine
animals within the Communities;

Annex VIII, Chapter C concerning the placing on the market of products of bovine
animal origin within the Communities;

Annex IX, Chapters A, B, C, D, F and G, concerning the import from third countries
of live bovine animals, products of bovine animal origin, bovine embryos and ova,
and other products of ruminant animal origin.

9

ANNEX II

"ANNEX VII

ERADICATION OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY

1.

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

a)

in the case of bovine animals:

–

–

–

–

–

–

all other ruminants on the holding of the animal in which the disease was
confirmed,

where the disease was confirmed in a female animal, all its embryos, ova
and its progeny collected or born within two years prior to, or after,
clinical onset of the disease,

all animals of the cohort of the animal
confirmed,

in which the disease was

the possible origin of the disease,

other animals, embryos or ova, on the holding of the animal in which the
disease was confirmed or on other holdings, which may have become
infected by the TSE agent or been exposed to the same feed or
contamination source,

the movement of potentially contaminated feedingstuffs, of other
material 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:

–

–

–

–

–

all ruminants other than ovine and caprine animals on the holding of the
animal in which the disease was confirmed,

in so far as they are identifiable, the parents, all embryos, ova and the last
progeny of the animal in which the disease was confirmed,

all animals of the cohort, to be defined in accordance with the procedure
laid down in Article 24(2), of the animal in which the disease was
confirmed,

all other ovine and caprine animals on the holding of the animal in which
the disease was confirmed in addition to those mentioned in the second
and third indents,

the possible origin of the disease and the identification of other holdings
on which there are animals, embryos or ova which may have become
infected by the TSE agent or been exposed to the same feed or
contamination source,

10

–

the movement of potentially contaminated feedingstuffs, other material
or any other means of transmission, which may have transmitted the BSE
agent to or from the holding in question.

2.

The measures laid down in Article 13(1)(c) shall comprise at least:

a)

b)

in case of confirmation of BSE in a bovine animal, the killing and complete
destruction of bovine animals and the destruction of embryos and ova
identified by the inquiry referred to in point 1(a), first, second and third indent.
The Member State may decide not to kill and destroy all bovine animals on the
holding of the animal in which the disease was confirmed as referred to in the
first indent of point 1(a), depending upon the epidemiological situation and
traceability of the animals on that holding;

in case of confirmation of BSE in an ovine or caprine animal, killing and
complete destruction of all animals, embryos and ova identified by the inquiry
referred to in point 1(b), second to sixth indents."

11

ANNEX III

"ANNEX XI

A.

Concerning the removal of specified risk material

1. Member States shall ensure that the specified risk material designated below is

removed and destroyed in accordance with points 7 to 11.

a)

The following tissues are designated as specified risk material:

i)

ii)

the skull including the brain and eyes, the tonsils, the vertebral
column excluding the vertebrae of the tail and the transverse
processes of the lumbar vertebrae, but including dorsal root ganglia
and spinal cord of bovine animals aged over 12 months, and the
intestines from the duodenum to the rectum of bovine animals of
all ages;

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

A decision may be taken in accordance with the procedure referred to in
Article 24(2) in particular with a view to adjust the age for the removal of
bovine vertebral column, in the light of the statistical probability of the
occurrence of BSE in the relevant age groups of the Community's bovine
population, based on the results of BSE monitoring, with particular
reference to testing of bovine animals, as established by Annex III.

b)

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

–

the entire head excluding the tongue, including the brain, eyes,
trigeminal ganglia and tonsils; the thymus, the spleen and the spinal
cord of bovine animals aged over 6 months.

2.

Specified risk material or processed material derived from it may be
despatched only with a view to subsequent incineration, in accordance with
point 11 or, where appropriate, point 7(b).

3. Member States shall ensure that bones of bovine, ovine and caprine animals are

not used for the production of mechanically recovered meat.

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

12

5.

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

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

–

–

–

–

–

–

–

–

–

–

–

fresh meat: the meat defined by Directive 64/433/EEC,

minced meat and meat preparations:
preparations defined by Directive 94/65/EC16;

the minced meat and meat

meat products: the meat products defined by Directive 77/99/EEC17;

other products of animal origin: other products of animal origin as
defined by Directive 77/99/EEC;

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

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

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

the processed animal protein referred to in Directive 92/118/EEC;

bones and bone products as referred to by Directive 92/118/EEC;

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

bovine intestines as referred to in Article 2(b)(v) of Directive 77/99/EEC.

a) When the above mentioned products of animal origin, containing
material from bovine, ovine or caprine animals are imported into the
Community from third countries or regions thereof, the health certificates
shall be accompanied by a declaration signed by the competent authority
of the country of production, worded as follows:

16

17

Council Directive 94/65/EC of 14 December 1994 laying down the requirements for the production and
placing on the market of minced meat and meat preparations (OJ L 368, 31.12.1994, p. 10).
Council Directive 77/99/EEC of 21 December 1976 on health problems affecting intra-Community
trade in meat products
last amended by Council
Directive 97/76/EC (OJ L 10, 16.1.1998, p. 25).

(OJ L 26, 31.1.1977, p. 85). Directive as

13

"The product of animal origin does not contain, and is not derived from
specified risk material as defined in Annex XI Section A to Regulation
(EC) No 999/2001 laying down rules for the prevention, control and
eradication of certain transmissible
spongiform encephalopahties,
produced after 31 March 2001, or mechanically recovered meat obtained
from bones of bovine, ovine or caprine animals, produced after 31 March
2001. After 31 March 2001 the animals have not been slaughtered after
stunning by means of gas injected into the cranial cavity or killed by the
same method or slaughtered by laceration after stunning of central
nervous tissue by means of an elongated rod-shaped instrument
introduced into the cranial cavity.

Carcasses, half carcasses and quarter carcasses may contain vertebral
column on import";

b)

Any reference to "products of animal origin" designates products of
animal origin listed in this point and does not concern other products of
animal origin containing or derived from those products of animal origin.

6.

Point 5 shall not apply to imports from:

Australia

Argentina

Botswana

Brazil

Chile

Costa Rica

Namibia

New-Zealand

Nicaragua

Paraguay

Uruguay

Singapore

Swaziland

14

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

a)

b)

specified risk material used in the production of products referred to in
Article 1(2) are used solely for authorised purposes;

specified risk material, especially where the removal takes place at
establishments or premises other than slaughterhouses,
is completely
separated from other waste not intended for incineration, is collected
separately and is disposed of in accordance with point l and points 8
to 11. Member States may decide to allow dispatch of heads or carcasses
containing specified risk material to another Member State after that
other Member State has agreed to receive the material and has approved
the specific conditions applicable to such transport.

However, carcasses, half carcasses and quarter carcasses containing no
including dorsal root
specified risk material other than vertebral column,
ganglia, may be imported into a Member State, or dispatched to another
Member State without the latter's prior agreement.

8. Member States shall ensure that specified risk material is removed at:

a)

b)

slaughterhouses;

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

appointed by the

competent

However, Member States may provide for the vertebral column to be removed
at points of sale to the consumer.

Where specified risk material is not removed from dead animals which have
not been slaughtered for human consumption, the parts of the body containing
specified risk material or the entire body must be treated as specified risk
material.

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

a)

by incineration without pre-processing; or,

15

b)

provided that
processing:

the dye or marking remains detectable, after pre-

i)

in accordance with the systems described in Chapters I to IV, VI
and VII of the Annex to Decision 92/562/EEC:

–

–

by incineration;

by co-incineration;

ii)

in accordance at least with the standards set out
in Annex I to
Council Decision 1999/534/EC, 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, without removal of the specified risk material, 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 approved and
verified 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 despatch specified risk material or the material processed
therefrom to other Member States for incineration under the conditions laid
down in Article 4(2) of Commission Decision 97/735/EC, where applicable.

This point may be amended at the request of a Member State to allow the
despatch of specified risk material or the material processed therefrom to third
countries for incineration, conditions governing such export having been
adopted.

12. By way of derogation from point 1 (a) (i), a decision may be taken in
accordance with the procedure referred to in Article 24 (2) to allow the use of
vertebral column and dorsal root ganglia from bovine animals:

a)

b)

born, continuously reared and slaughtered in Member States for which a
scientific evaluation established that the occurrence of BSE in native
bovine animals is highly unlikely, or unlikely but not excluded; or,

born after the date of effective enforcement of the prohibition on the
feeding of mammalian protein to ruminants in Member States with
reported BSE in native animals or for which a scientific evaluation
established that the occurrence of BSE in native bovine animals is likely.

The United Kingdom, Portugal, Finland, Sweden and Austria may benefit from
this derogation on the basis of previously submitted and evaluated evidence.
Other Member States may apply for this derogation by submitting conclusive
supporting evidence to the Commission regarding point
(a) or (b), as
appropriate.

16

in addition to the
Member States benefiting from this derogation shall,
requirements laid down in Annex III, Chapter A, Section I, ensure that one of
the approved rapid tests listed in Annex X, Chapter C, point 4 is applied to all
bovine animals over 30 months of age which:

a)

have died on the farm or in transport, but which have not been
slaughtered for human consumption, with the exception of those dead
animals in remote areas with a low animal density situated in Member
States where the occurrence of BSE is unlikely;

b)

were subject to normal slaughter for human consumption.

This derogation shall not be granted to allow the use of vertebral column and
dorsal root ganglia from bovine animals aged over 30 months from the United
Kingdom or from Portugal with the exception of the Autonomous Region of
the Azores.

Experts from the Commission may carry out on-the-spot checks to further
verify the submitted evidence in accordance with Article 21."

17

"C.

Concerning prohibitions on animal feeding

ANNEX IV

Council Decision 2000/766/EC concerning certain protection measures with regard
to transmissible spongiform encephalopathies and the feeding of animal protein, and
Commission Decision 2001/9/EC concerning control measures required for the
implementation of Council Decision 2000/766/EC, remain in force.

A decision may be taken in accordance with the procedure referred to in
Article 24(2) to adapt Decision 2000/766/EC to the situation of each Member State
in the light of the results of Commission inspections and the incidence of BSE, based
on the results of BSE monitoring, with particular reference to testing of bovine
animals, as established by Annex III.

D.

Concerning placing on the market and export

1.

The following provisions remain in force as transitional measures:

Commission Decision 92/290/EEC of 14 May 1992 concerning certain
protection measures relating to bovine embryos
in respect of bovine
spongiform encephalopathy (BSE) in the United Kingdom.

Council Decision 98/256/EC of 16 March concerning emergency measures to
protect against bovine spongiform encephalopathy, amending Decision
94/474/EC and repealing Decision 96/239/EC.

Commission Decision 98/351/EC of 29 May 1998 setting the date on which
dispatch from Northern Ireland of bovine products under the Export Certified
Herds Scheme may commence by virtue of Article 6(5) of Council Decision
98/256/EC.

Commission Decision 1999/514/EC of 23 July 1999 setting the date on which
dispatch from the United Kingdom of bovine products under the date-based
export scheme may commence by virtue of Article 6(5) of Council Decision
98/256/EC.

Commission Decision 2000/345/EC of 22 May 2000 setting the date on which
dispatch from Portugal to Germany of certain products for the purpose of
incineration may commence by virtue of Article 3(6) of Decision 98/653/EC.

Commission Decision 2000/371/EC of 6 June 2000 setting the date on which
dispatch of fighting bulls from Portugal to France may commence by virtue of
Article 3(7) of Decision 98/653/EC.

Commission Decision 2000/372/EC of 6 June 2000 setting the date on which
dispatch of fighting bulls from Portugal to Spain may commence by virtue of
Article 3(7) of Decision 98/653/EC.

Commission Decision 2001/376/EC of 18 April 2001 concerning measures
made necessary by the occurrence of bovine spongiform encephalopathy in
Portugal and implementing a date-based export scheme.

18

2.

3.

Imports of bovine animals are to be subject
international animal health certificate attesting that:

to the presentation of an

a)

b)

the feeding of ruminants with proteins derived from mammals has been
banned and the ban has been effectively enforced;

the bovine animals intended for export to the Community are identified
by a permanent identification system enabling them to be traced back to
the dam and herd of origin and are not the progeny of BSE suspected
females.

Imports of bovine embryos and ova are to be subject to the presentation of an
international animal health certificate attesting that the feeding of ruminants
with proteins derived from mammals has been banned and the ban has been
effectively enforced.

4.

Points 2 and 3 shall not apply to imports from:

Australia

Argentina

Botswana

Brazil

Chile

Costa Rica

Namibia

New-Zealand

Nicaragua

Paraguay

Uruguay

Singapore

Swaziland"

19