Common Position (EC) No 32/2006 of 23 November 2006 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to the adoption of a Regulation of the European Parliament and of the Council amending Regulation (EC) No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies
Date: 2006-11-23
Institutions: Council of the European Union
Subjects: animal feedingstuffs, animal product, bovine spongiform encephalopathy, cattle, disease prevention, food safety, goat, health control, sheep, slaughter of animals, veterinary inspection

19.12.2006

EN

Official Journal of the European Union

C 311E/1

I

(Information)

COUNCIL

COMMON POSITION (EC) No 32/2006

adopted by the Council on 23 November 2006

with a view to the adoption of Regulation (EC) No …/2006 of the European Parliament and of the
Council of … amending Regulation (EC) No 999/2001 laying down rules for the prevention,
control and eradication of certain transmissible spongiform encephalopathies

(Text with EEA relevance)

(2006/C 311 E/01)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,

(2)

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

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Economic and
Social Committee (1),

(3)

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article
251 of the Treaty (2),

Whereas:

(1)

Regulation (EC) No 999/2001 of the European Parlia-
ment and of the Council of 22 May 2001 laying down
rules for the prevention, control and eradication of
certain transmissible spongiform encephalopathies (3) is
intended to provide a single legal framework for trans-
missible spongiform encephalopathies
in the
Community.

(TSEs)

(1) OJ C 234, 22.9.2005, p. 26.
(2) Opinion of the European Parliament of 17 May 2006 (not yet
published in the Official Journal), Council common position of 23
November 2006 and Position of the European Parliament of … (not
yet published in the Official Journal).

(3) OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commis-
sion Regulation (EC) No 1041/2006 (OJ L 187, 8.7.2006, p. 10).

(4)

(5)

Regulation (EC) No 932/2005 of the European Parlia-
ment and of the Council of 8 June 2005 amending
Regulation (EC) No 999/2001 laying down rules for the
prevention, control and eradication of certain transmis-
sible spongiform encephalopathies as regards the exten-
sion of the period for transitional measures (4) prolonged
the period of application of the transitional measures
provided for in Regulation (EC) No 999/2001 until 1
July 2007 at the latest.

During the General Session of the World Organisation
for Animal Health in May 2003, a Resolution was
adopted to simplify the current international criteria for
the classification of countries according to their Bovine
Spongiform Encephalopathy (BSE) risk. A proposal was
adopted at the General Session in May 2005. The Arti-
cles of Regulation (EC) No 999/2001 should be adapted
to reflect the new internationally agreed categorisation
system.

New developments concerning sampling and analysis
will require comprehensive amendments to Annex X to
Regulation (EC) No 999/2001. It is therefore necessary
to make certain technical amendments to the existing
in Regulation (EC) No
definition of
999/2001 in order to facilitate amendment of the struc-
ture of that Annex at a later stage.

‘rapid tests’

In the interests of clarity of Community legislation, it is
appropriate to clarify that the definition of ‘mechanically
separated meat’ provided for in other Community legis-
lation on food safety should be applicable in Regulation
(EC) No 999/2001 in the context of TSE eradication
measures.

(4) OJ L 163, 23.6.2005, p. 1.

(6)

(7)

(8)

(9)

C 311E/2

EN

Official Journal of the European Union

19.12.2006

Regulation (EC) No 999/2001 establishes a monitoring
programme for BSE and scrapie. In its opinion of 6-
7 March 2003, the Scientific Steering Committee recom-
mended the introduction of a monitoring programme
for TSEs in cervids. Therefore the monitoring system
provided for in that Regulation should be extended to
other TSEs, with the possibility to adopt
further
measures to implement that system at a later stage.

(11) Although stunning by injection of gas in the cranial
cavity is prohibited within the Community, injection of
gas may also occur after stunning. It is therefore neces-
sary to amend the relevant provisions on slaughter
methods in Regulation (EC) No 999/2001 with a view
to prohibiting gas injection into the cranial cavity after
stunning.

transitional measure

A harmonised breeding programme to select for resis-
tance to TSEs in ovine animals has been put in place as
a
by Commission Decision
2003/100/EC of 13 February 2003 laying down
establishment of
minimum requirements
for
resistance to transmissible
breeding programmes for
in sheep (1). Regulation
spongiform encephalopathies
(EC) No 999/2001 should be amended to provide a
permanent legal basis for that programme, as well as the
possibility of amending such programmes
to take
account of the evaluated scientific results and overall
consequences of their implementation.

the

concerning

Regulation (EC) No 999/2001 prohibits the feeding of
certain processed animal proteins to certain animals,
with the possibility to provide for derogations. New
developments
animal
to be made to
feeding may require amendments
Annex IV to that Regulation. It is necessary to make
certain technical amendments to the existing wording of
the corresponding Article in order to facilitate amend-
ment of the structure of that Annex at a later stage.

prohibitions

on

Regulation (EC) No 1774/2002 of the European Parlia-
ment and of the Council of 3 October 2002 laying
down health rules concerning animal by-products not
intended for human consumption (2) establishes rules for
the disposal of specified risk materials and animals
infected by TSEs. Rules on transit through the Com-
munity of products of animal origin have now been
adopted. Accordingly, in the interests of consistency of
Community legislation, the existing rules in Regulation
(EC) No 999/2001 on the disposal of such materials and
animals should be replaced by a reference to Regulation
(EC) No 1774/2002, and the reference to rules on transit
in Regulation (EC) No 999/2001 should be deleted.

(10) New developments concerning specified risk materials
will also require comprehensive amendments to Annex V
to Regulation (EC) No 999/2001. It is necessary to make
certain technical amendments to the existing wording of
the corresponding provisions of that Regulation in order
to facilitate amendment of the structure of that Annex at
a later stage.

(12)

(13)

(14)

(15)

Commission Regulation (EC) No 1915/2003 of 30
October 2003 amending Annexes VII, VIII and IX to
Regulation (EC) No 999/2001 of the European Parlia-
ment and of the Council as regards the trade and import
of ovine and caprine animals and the measures following
the confirmation of transmissible spongiform encephalo-
pathies in bovine, ovine and caprine animals (3) sets out
new provisions on eradication of scrapie in ovine and
caprine animals. Accordingly, it is necessary to prohibit
the movement of ovine and caprine animals from hold-
ings where scrapie is officially suspected.

Based on evolving scientific knowledge, Regulation (EC)
No 999/2001 should allow the extension to other
species of the scope of the rules concerning the placing
on the market and export of bovine, ovine and caprine
animals, their semen, embryos and ova.

The opinion of
the Scientific Steering Committee of
26 June 1998 indicates that certain restrictions regarding
sourcing of raw material
for the manufacture of di-
calcium phosphate should be observed. Accordingly, di-
calcium phosphate should be removed from the list of
products which are not subject to restrictions on placing
on the market under Regulation (EC) No 999/2001. The
absence of restrictions applicable to milk and dairy
products should be clarified.

Based on evolving scientific knowledge and risk classifi-
cation, and notwithstanding the possibility to adopt safe-
guard measures, Regulation (EC) No 999/2001 should
permit the adoption in accordance with the comitology
procedure of more specific requirements for the placing
on the market and export of products of animal origin
originating from Member States or third countries with
a controlled or undetermined risk of TSE.

(16)

The measures necessary for the implementation of Regu-
lation (EC) No 999/2001 should be adopted in accord-
ance with Council Decision 1999/468/EC of 28 June
1999 laying down the procedures for the exercise of
implementing powers conferred on the Commission (4).

(1) OJ L 41, 14.2.2003, p. 41.
(2) OJ L 273, 10.10.2002, p. 1. Regulation as last amended by
Commission Regulation (EC) No 208/2006 (OJ L 36, 8.2.2006, p.
25).

(3) OJ L 283, 31.10.2003, p. 29.
(4) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision

2006/512/EC (OJ L 200, 22.7.2006, p. 11.)

19.12.2006

EN

Official Journal of the European Union

C 311E/3

(17)

the animals,

In particular, the Commission should be empowered to
adopt decisions approving the rapid tests, adapting the
age of
introducing the tolerance level,
allowing feeding of young animals of ruminant species
with proteins derived from fish and extending certain
provisions to other animal species;
to establish rules
providing for exemptions to remove and destroy specific
risk material;
to demonstrate
to establish criteria
situation and
improvement of
criteria for granting exemptions from certain restrictions
as well as production processes. Since those measures
are of general scope and are designed to amend non-
essential elements of that Regulation and or to supple-
ment that Regulation by the addition of new non-essen-
tial elements,
those measures should be adopted in
accordance with the regulatory procedure with scrutiny
provided for in Article 5a of Decision 1999/468/EC.

epidemiological

the

(18)

Regulation (EC) No 999/2001 should therefore be
amended accordingly,

HAVE ADOPTED THIS REGULATION:

of each species. Pursuant to the precautionary
principle and in keeping with the natural diet
and living conditions of ruminants, it is therefore
necessary to maintain the prohibition on the
feeding of animal proteins to ruminants in forms
not normally constituting part of their natural
diet.

(11b)

Mechanically separated meat
is obtained by
removing meat from bones in such a way that
the muscle fibre structure is destroyed or modi-
fied. It can contain parts of the bones and the
periosteum (bone skin). Thus, mechanically sepa-
rated meat is not comparable with regular meat.
Consequently its use for human consumption
should be reviewed.

(**) OJ C 174 E, 14.7.2005, p. 178.’;

3) in Article 3, paragraph 1 shall be amended as follows:

(a) point (l) shall be replaced by the following:

‘(l) rapid tests:

listed in
Annex X, for which the results are known within
24 hours;’;

screening methods

the

Article 1

(b) the following points shall be added:

Regulation (EC) No 999/2001 is hereby amended as follows:

1) the following recital shall be inserted:

‘(8a)

of

to

feeding

non-ruminants

The
certain
processed animal proteins originating from non-
ruminants should be allowed taking into account
the prohibition on intra-species recycling as laid
down in Regulation (EC) No 1774/2002 of the
European Parliament and of
the Council of
3 October 2002 laying down health rules
concerning animal by-products not intended for
human consumption (*) and the control aspects
linked to the differentiation of
in particular
processed animal proteins
specific to certain
species as laid down in the Communication on
the TSE Road map adopted by the Commission
on 15 July 2005.

(*) OJ L 273, 10.10.2002, p. 1. Regulation as

amended
208/2006 (OJ L 36, 8.2.2006, p. 25).’;

by Commission Regulation

last
(EC) No

‘(n) mechanically separated meat or

the
product obtained by removing meat from flesh-
bearing bones after boning, using mechanical
means resulting in the loss or modification of the
muscle fibre structure;

“MSM”:

(o) passive surveillance: the reporting of all animals
suspected of being infected by a TSE and, where
TSE cannot be excluded by clinical investigation,
the laboratory testing of such animals;

(p) active surveillance:

the testing of animals not
reported as suspected of being infected by a TSE,
such as emergency slaughtered animals, animals
with observations at ante mortem inspection,
fallen stock, healthy slaughtered animals and
animals culled in connection with a TSE case, in
particular in order to determine the evolution and
prevalence of TSE in a country or region thereof.’;

4) Article 5 is hereby amended as follows:

(a) paragraph 1 shall be replaced by the following:

2) the following recitals shall be inserted:

‘(11a)

In its resolution of 28 October 2004 (**), the
European Parliament expressed concerns about
feeding animal proteins to ruminants as they do
not form part of the natural nutrition of adult
cattle. In the wake of the BSE crisis and the foot-
increasingly
crisis
and-mouth disease
become accepted that the best way to ensure
human and animal health is to keep and nourish
animals in a way that respects the particularities

it has

The BSE status of Member States or third coun-
‘1.
tries or regions thereof
referred to as
“countries or regions”) shall be determined by classifi-
cation into one of the following three categories:

(hereinafter

— negligible BSE risk as defined in Annex II,

— controlled BSE risk as defined in Annex II,

— undetermined BSE risk as defined in Annex II.

C 311E/4

EN

Official Journal of the European Union

19.12.2006

The BSE status of countries or regions may be deter-
mined only on the basis of the criteria set out in
Annex II, Chapter A. These criteria shall include the
outcome of a risk analysis on the basis of all the poten-
tial factors for the appearance of bovine spongiform
encephalopathy as defined in Annex II, Chapter B, and
their development over time, as well as comprehensive
active and passive surveillance measures taking into
account the risk category of the country or region.

Member States, and third countries wishing to be
retained on the list of third countries approved for the
export to the Community of the live animals or of the
products covered by this Regulation, shall submit to
the Commission an application for their BSE status to
be determined, accompanied by the relevant informa-
tion on the criteria set out in Annex II, Chapter A, and
on the potential risk factors specified in Annex II,
Chapter B, and their development over time.’;

(b) paragraph 4 shall be replaced by the following:

‘4. Member States and third countries which have
not submitted an application in accordance with the
third subparagraph of paragraph 1 shall, with respect
to the dispatch from their territory of live animals and
products of animal origin, comply with the import
requirements applicable to countries with an undeter-
mined BSE risk, until they have submitted such an
application and a final decision has been taken on
their BSE status.’;

5) Article 6 is hereby amended as follows:

(a) paragraph 1 shall be replaced by the following:

‘1.
Each Member State shall carry out an annual
monitoring programme for TSEs based on active and
passive surveillance in accordance with Annex III. If
available for the animal species, that programme shall
include a screening procedure using rapid tests.

Rapid tests shall be approved for that purpose in
accordance with the procedure
to in
Article 24(3) and listed in Annex X.’;

referred

Member States may decide to derogate from the provi-
sion under point (c) in remote areas with a low animal
density, where no collection of dead animals is orga-
nised. Member States making use of this possibility
shall inform the Commission and submit a list of the
areas concerned together with a justification for the
derogation. The derogation shall not cover more than
10 % of the bovine population in a Member State.

1b.
After consultation of the appropriate scientific
committee, the age laid down in paragraph 1a(a) and
(c) may be adapted according to scientific progress in
to in
accordance with the procedure
Article 24(3).

referred

At the request of a Member State which can demon-
strate the improvement of the epidemiological situa-
tion of the country, according to certain criteria to be
laid down in accordance with the procedure referred
to in Article 24(3), the annual monitoring programmes
for that particular Member State may be revised.

The Member State concerned shall provide proof of its
capability to determine
the
measures in place and ensure protection of human and
animal health based on a comprehensive risk analysis.
In particular, the Member State shall demonstrate:

effectiveness of

the

(a) a clearly declining or consistently low BSE preva-

lence, based on up-to-date testing results;

(b) that it has implemented and enforced for at least
six years a full BSE testing scheme (Community
legislation on traceability and identification of live
animals and BSE surveillance);

(c) that it has implemented and enforced for at least
six years Community legislation on total feed ban
for farmed animals.’;

(c) the following paragraph shall be added:

‘5.
Rules for the implementation of this Article shall
be adopted in accordance with the procedure referred
to in Article 24(2).’;

(b) the following paragraphs shall be inserted:

6) the following Article shall be inserted:

‘1a.
The annual monitoring programme referred to
in paragraph 1 shall cover as a minimum the following
subpopulations:

‘Article 6a

Breeding programmes

(a) all bovine animals above 24 months of age sent
for emergency slaughter or with observations at
ante mortem inspections;

(b) all bovine animals above 30 months of age slaugh-

tered normally for human consumption;

(c) all bovine animals above 24 months of age not
slaughtered for human consumption, which have
died or been killed on the farm, during transport
or in an abattoir (fallen stock).

1. Member States may introduce breeding programmes
to select for resistance to TSEs in their ovine populations.
Those programmes shall include a framework to recognise
the TSE-resistant status of certain flocks and may be
extended to include other animal species based on scien-
tific evidence corroborating the resistance to TSE of par-
ticular genotypes of those species.

2.
Specific rules for the programmes provided for in
paragraph 1 of this Article shall be adopted in accordance
with the procedure referred to in Article 24(2).

19.12.2006

EN

Official Journal of the European Union

C 311E/5

States

introduce

3. Member
breeding
which
programmes shall submit regular reports to the Commis-
sion in order to enable the programmes to be scientifically
evaluated, in particular with regard to their impact on the
incidence of TSEs but also on genetic diversity and varia-
bility and on the maintenance of old or rare ovine breeds
or of those that are well-adapted to a particular region.
The scientific results and overall consequences of
the
breeding programmes shall be evaluated regularly, and
where necessary,
those programmes shall be amended
accordingly.’;

7) Article 7 is hereby amended as follows:

(a) paragraphs 1 to 4 shall be replaced by the following:

The feeding to ruminants of protein derived

‘1.
from animals shall be prohibited.

2.
The prohibition provided for in paragraph 1
shall be extended to animals other than ruminants and
restricted, as regards the feeding of those animals with
products of
in accordance with
Annex IV.

animal origin,

3.
Paragraphs 1 and 2 shall apply without prejudice
to the provisions laid down in Annex IV setting out
the derogations from the prohibition contained in
those paragraphs.

The Commission may decide in accordance with the
procedure referred to in Article 24(3), based on a
scientific assessment of the dietary needs of young
ruminants and subject to the rules adopted for the
implementation of this Article provided for in para-
graph 5 of this Article, and following an assessment of
the control aspects of this derogation, to allow the
feeding of young animals of ruminant species with
proteins derived from fish.

4. Member States, or regions thereof, with an unde-
termined BSE risk shall not be permitted to export or
store feed intended for farmed animals which contains
protein derived from mammals or feed intended for
mammals, except feed for dogs, cats and fur animals,
which contains processed protein derived from
mammals.

Third countries, or regions thereof, with an undeter-
mined BSE risk shall not be permitted to export to the
Community feed intended for farmed animals which
contains protein derived from mammals or
feed
intended for mammals, except feed for dogs, cats and
fur animals, which contains processed protein derived
from mammals.

At the request of a Member State or third country a
decision in accordance with the procedure referred to
following detailed
in Article 24(2) may be taken,
criteria to be laid down in accordance with the proce-
dure referred to in Article 24(3), to grant individual
exemptions from the restrictions in this paragraph.
Any exemption shall take account of the provisions
provided for in paragraph 3 of this Article.’;

(b) the following paragraph shall be inserted:

‘4a.
Based on a favourable risk assessment taking
into account at least the amount and possible source
of contamination and the final destination of
the
consignment, a decision may be taken in accordance
with the procedure referred to in Article 24(3) to intro-
duce a tolerance level
for insignificant amounts of
animal proteins in feedingstuffs caused through adven-
titious and technically unavoidable contamination.’;

(c) paragraph 5 shall be replaced by the following:

Rules for the implementation of this Article, in
‘5.
particular rules on the prevention of cross-contamina-
tion and on the methods of sampling and analysis
required to check compliance with this Article, shall be
adopted in accordance with the procedure referred to
in Article 24(2). Those rules shall be based on a report
the Commission covering sourcing, processing,
of
control and traceability of
feedingstuffs of animal
origin.’;

8) in Article 8, paragraphs 1 to 5 shall be replaced by the

following:

‘1.
The specified risk material shall be removed and
disposed of in accordance with Annex V to this Regulation
and with Regulation (EC) No 1774/2002. It shall not be
imported into the Community. The list of specified risk
material referred to in Annex V shall include at least the
brain, spinal cord, eyes and tonsils of bovine animals aged
over 12 months and the vertebral column of bovine
animals above an age to be determined in accordance with
the procedure referred to in Article 24(3). Taking into
account the different risk categories laid down in the first
subparagraph of Article 5(1) and the requirements of
Article 6(1a) and (1b) (b), the list of specified risk material
in Annex V shall be amended accordingly.

Paragraph 1 of this Article shall not apply to tissues
2.
from animals which have undergone an alternative test
approved for that distinct purpose in accordance with the
procedure referred to in Article 24(3) provided that this
test is listed in Annex X, is applied under the conditions
provided for in Annex V and the test results are negative.

The Member States which authorise the use of an alterna-
tive test pursuant to this paragraph shall inform the other
Member States and the Commission.

regions

In Member States, or

3.
thereof, with a
controlled or undetermined BSE risk, the laceration, after
stunning, of central nervous tissue by means of an elon-
gated rod-shaped instrument introduced into the cranial
cavity, or by means of gas injection into the cranial cavity
in connection with stunning, shall not be used on bovine,
ovine or caprine animals whose meat
is intended for
human or animal consumption.

4.
The data relating to age set out in Annex V may be
adjusted. Such adjustments shall be based on the latest
proven scientific findings concerning the statistical prob-
ability of the occurrence of a TSE in the relevant age
groups of
the Community's bovine, ovine and caprine
population.

C 311E/6

EN

Official Journal of the European Union

19.12.2006

5.
Rules providing for exemptions from paragraphs 1
to 4 of this Article may be adopted in accordance with the
procedure referred to in Article 24(3), with regard to the
date of the effective enforcement of the feeding prohibition
provided for in Article 7(1) or, as appropriate for third
countries or regions thereof with a controlled BSE risk,
with regard to the date of the effective enforcement of the
ban of mammalian protein in feed for ruminants with a
view to limiting the requirements to remove and destroy
specified risk material to animals born before that date in
the countries or regions concerned.’;

9) in Article 9, paragraphs 1 and 2 shall be replaced by the

following:

‘1.
The products of animal origin listed in Annex VI
shall be produced using production processes approved in
accordance with the procedure referred to in Article 24(3).

2.
Bones of bovine, ovine and caprine animals from
countries or regions with a controlled or undetermined
BSE risk shall not be used for the production of mechani-
cally separated meat
the
Member States shall submit a report to the Commission
on the use and the production method of MSM in their
territory. This report shall
include a statement as to
whether the Member State intends to continue with the
production of MSM.

(MSM). Before 1 July 2008,

The Commission shall thereupon present a communication
to the European Parliament and the Council on the future
necessity and use of MSM in the Community, including
the information policy towards consumers.’;

10) Article 12 is hereby amended as follows:

(a) paragraph 1 shall be replaced by the following:

‘1.
Any animal suspected of being infected by a TSE
shall be either placed under an official movement
restriction until the results of a clinical and epidemio-
logical examination carried out by the competent
authority are known, or killed for laboratory examina-
tion under official control.

If a TSE is officially suspected in a bovine animal at a
holding in a Member State, all other bovine animals at
that holding shall be placed under an official move-
ment restriction until the results of the examination
are available. If a TSE is officially suspected in an ovine
or caprine animal at a holding in a Member State, all
other ovine and caprine animals at that holding shall
be placed under an official movement restriction until
the results are available.

However, if there is evidence that the holding where
the animal was present when the TSE was suspected is
unlikely to be the holding where the animal could
have been exposed to the TSE, the competent authority
may decide that only the animal suspected of being
infected shall be placed under an official movement
restriction.

If considered necessary, the competent authority may
also decide that other holdings or only the holding of
exposure
control
shall be placed under official
information avail-
depending on the epidemiological
able.

In accordance with the procedure referred to in
Article 24(2) and by way of derogation from the offi-
cial movement restrictions provided for in this para-
graph, a Member State may be exempted from imple-
menting such restrictions if it applies measures offering
equivalent safeguards based on an appropriate assess-
ment of
the possible risks for human and animal
health.’;

(b) paragraph 3 shall be replaced by the following:

‘3.
All parts of the body of the suspect animal shall
be either retained under official control until a negative
diagnosis has been made, or disposed of in accordance
with Regulation (EC) No 1774/2002.’;

11) in Article 13, paragraph 1 is hereby amended as follows:

(a) point (a) of the first subparagraph shall be replaced by

the following:

‘(a) all parts of

the body of

the animal shall be
disposed of in accordance with Regulation (EC)
No 1774/2002 except
for material retained for
records in accordance with Annex III, Chapter B,
of this Regulation.’;

(b) point (c) of the first subparagraph shall be replaced by

the following:

‘(c) all animals and products thereof at risk, as listed in
Annex VII, point 2, of this Regulation, identified
by the inquiry referred to in point (b) of this para-
graph shall be killed and disposed of in accordance
with Regulation (EC) No 1774/2002.’;

(c) after

the

first
paragraph shall be inserted:

subparagraph,

the

following sub-

‘At the request of a Member State and based on a
taking particularly into
favourable risk assessment
account the control measures in that Member State, a
decision may be taken in accordance with the proce-
dure referred to in Article 24(2) to allow the use of
bovine animals referred to in this paragraph until the
end of their productive lives.’;

12) in Article 15, paragraph 3 shall be replaced by the

following:

‘3.
In accordance with the procedure referred to in
Article 24(3), the provisions of paragraphs 1 and 2 may
be extended to other animal species.

Rules for implementing this Article may be adopted
referred to in

4.
in accordance with the procedure
Article 24(2).’;

19.12.2006

EN

Official Journal of the European Union

C 311E/7

13) Article 16 is hereby amended as follows:

(e) criteria for granting exemptions from the restrictions

(a) in paragraph 1, point (b) shall be replaced by the

following:

‘(b) milk and dairy products, hides and skins, and gela-
tine and collagen derived from hides and skins.’;

(b) paragraphs 2 and 3 shall be replaced by the following:

‘2.
Products of animal origin imported from a third
country with a controlled or undetermined BSE risk
shall come from healthy bovine, ovine and caprine
animals which have not been subjected to a laceration
of the central nervous tissue or gas injection into the
cranial cavity as referred to in Article 8(3).

Food products of animal origin containing mate-
3.
rial obtained from bovine animals originating in a
country or region with an undetermined BSE risk shall
not be placed on the market unless they come from
animals which:

(a) were born eight years after the date from which
the prohibition on the feeding to ruminants of
animal protein derived from mammals was effec-
tively enforced; and

(b) were born, raised and have stayed in herds with a
certified history of freedom from BSE for at least
seven years.

Furthermore, food products of ruminant origin shall
not be dispatched from a Member State or a region
thereof with an undetermined BSE risk to another
Member State or be imported from a third country
with an undetermined BSE risk.

This prohibition shall not apply to products of animal
origin listed in Annex VIII, Chapter C, and fulfilling the
requirements of Annex VIII, Chapter C.

They must be accompanied by an animal health certifi-
cate issued by an official veterinarian certifying that
they have been produced in conformity with this
Regulation.’;

14) the following Article shall be inserted:

‘Article 23a

The following measures for implementation of this Regu-
lation shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 24(3):

(a) approval of the rapid tests referred to in Article 6(1)

and Article 8(2),

(b) adaptation of the age referred to in Article 6(1b),

(c) criteria to demonstrate improvement of the epidemio-

logical situation referred to in Article 6(1b),

referred to in Article 7(4),

(f) decision to introduce a tolerance level as referred to in

Article 7(4a),

(g) decision on age as referred to in Article 8(1),

(h) rules providing for exemptions to remove and destroy
specified risk material as referred to in Article 8(5),

(i) production processes referred to in Article 9(1),

(j) decision to extend certain provisions to other animal

species as referred to in Article 15(3).

These measures shall be annexed to this Regulation.’;

15) Article 24 shall be replaced by the following:

‘Article 24

Committees

1.
The Commission shall be assisted by the Standing
Committee on the Food Chain and Animal Health.
However, the Standing Committee on Zootechnics shall
also be consulted by the Commission with regard to
Article 6a.

2. Where reference is made to this paragraph, Articles
5 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

The time-limits referred to in Article 5(6) of that Decision
shall be three months and,
in the case of safeguard
measures referred to in Article 4(2) of this Regulation,
15 days.

3. Where reference is made to this paragraph, Article
5a (1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8
thereof.’;

16) the following Article shall be inserted:

‘Article 24a

Decisions to be adopted in accordance with one of the
procedures referred to in Article 24 shall be based on an
appropriate assessment of the possible risks for human
and animal health and shall, taking into account existing
scientific evidence, maintain, or if scientifically justified
increase,
the level of protection of human and animal
health ensured in the Community.’.

Article 2

(d) decision to allow feeding of young animals of rumi-
nant species with proteins derived from fish as referred
to in Article 7(3),

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

C 311E/8

EN

Official Journal of the European Union

19.12.2006

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

Done at …

For the European Parliament

The President

…

For the Council

The President

…

19.12.2006

EN

Official Journal of the European Union

C 311E/9

STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. The Commission forwarded to the Council on 7 December 2004 a proposal for a Regulation of the
European Parliament and of the Council amending Regulation (EC) No 999/2001.The proposal is
based on Article 152 of the Treaty.

2. The European Parliament adopted its opinion at first reading on 17 May 2006. The Economic and

Social Committee gave its opinion on 9 March 2005.

3. On 23 November 2006, the Council adopted its Common Position in accordance with Article 251

of the Treaty.

II. OBJECTIVES

The proposed Regulation intends to address Member States' concerns, particularly regarding:

— Categorisation of countries with regard to BSE risk

— Definition of passive and active surveillance measures

— and above all, the possibility of adapting the current monitoring system to improvements in the

epidemiological situation of the Member State concerned.

III. ANALYSIS OF THE COMMON POSITION

1. General context

An agreement at first reading was reached on this dossier in May 2006.

The revision of the draft Regulation by lawyer-linguists of both institutions was carried out on
19 September 2006 (PE-CONS 3618/06).

In the meanwhile, the Council adopted Decision 2006/512/EC introducing a new procedure named
‘regulatory procedure with scrutiny’ into Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of implementing powers conferred on the Commission
(Article 5a).

The new Committee procedure has to be followed to adopt measures of general scope which seek
to amend non-essential elements of a basic instrument adopted in accordance with the procedure
referred to in Article 251 of the Treaty, inter alia by deleting some of those elements or by supple-
menting the instrument by the addition of new nonessential elements.

2. Adaptations introduced by the Council

Regulation (EC) No 999/2001 always refers to the Committee regulatory procedure when imple-
menting powers are conferred to the Commission and therefore has to be adapted, when appro-
priate, to the new Committee regulatory procedure with scrutiny.

Due to the urgency of the matter (1), it will be necessary that the adoption of this Regulation by the
Parliament and the Council take place by December 2006.

The Commission has accepted the common position agreed by the Council.

(1) Several implementing measures are blocked at Commission level.