Regulation (EC) No 1923/2006 of the European Parliament and of the Council of 18 December 2006 amending Regulation (EC) No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies   (Text with EEA relevance)
Date: 2006-12-18
Institutions: Council of the European Union, European Parliament
Subjects: EU control, animal disease, disease prevention, health control, public health

30.12.2006

EN

Official Journal of the European Union

L 404/1

I

(Acts whose publication is obligatory)

REGULATION (EC) No 1923/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 18 December 2006

amending Regulation (EC) No 999/2001 laying down rules for the prevention, control and eradica-
tion of certain transmissible spongiform encephalopathies

(Text with EEA relevance)

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

(2)

Regulation (EC) No 932/2005 of the European Parlia-
ment and of the Council of 8 June 2005 amending Regu-
lation (EC) No 999/2001 as regards the extension 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.

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),

Having consulted the Committee of the Regions,

(3)

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 Articles
of Regulation (EC) No 999/2001 should be adapted to
reflect
the new internationally agreed categorisation
system.

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

(4)

Whereas:

New developments concerning sampling and analysis will
require comprehensive amendments to Annex X to Regu-
lation (EC) No 999/2001.
It is therefore necessary to
make certain technical amendments to the existing defini-
tion of ‘rapid tests’ in Regulation (EC) No 999/2001 in
order to facilitate amendment of the structure of that
Annex at a later stage.

(1)

Regulation (EC) No 999/2001 (3) is intended to provide a
single legal framework for transmissible spongiform ence-
phalopathies (TSEs) in the Community.

(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 24
November 2006 (not yet published in the Official Journal) and Position
of the European Parliament of 12 December 2006 (not yet published in
the Official Journal).

(3) OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission

Regulation (EC) No 1041/2006 (OJ L 187, 8.7.2006, p. 10).

(5)

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 legisla-
tion 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.

L 404/2

EN

Official Journal of the European Union

30.12.2006

(6)

(7)

(8)

(9)

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
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.

in cervids. Therefore

(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 stun-
ning.

Commission

A harmonised breeding programme to select for resis-
tance to TSEs in ovine animals has been put in place as a
Decision
by
transitional measure
2003/100/EC of 13 February 2003 laying down
minimum requirements for the establishment of breeding
programmes for resistance to transmissible spongiform
in sheep (1). Regulation (EC) No
encephalopathies
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.

Regulation (EC) No 999/2001 prohibits the feeding of
certain processed animal proteins to certain animals, with
the possibility to provide for derogations. New develop-
ments concerning prohibitions on animal feeding may
require amendments to be made to Annex IV to that
Regulation.
is necessary to make certain technical
the corre-
to the existing wording of
amendments
sponding Article in order to facilitate amendment of the
structure of that Annex at a later stage.

It

for

rules

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
the
disposal of specified risk materials and animals infected
by TSEs. Rules on transit through the Community of
products of animal origin have now been adopted.
in the interests of consistency of Com-
Accordingly,
munity 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.

(12)

Commission Regulation (EC) No 1915/2003 amending
Regulation (EC) No 999/2001 (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 holdings where scrapie is
officially suspected.

(13)

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.

(14)

(15)

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 classifica-
tion, 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.

(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.

(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 Commis-

sion 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.)

30.12.2006

EN

Official Journal of the European Union

L 404/3

(17)

the animals,

from the requirement

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
to establish rules
provisions to other animal species;
providing for exemptions
to
remove and destroy specific risk material; to establish
criteria to demonstrate improvement of the epidemiolo-
gical situation and 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 Regulation (EC) No
999/2001 and/or to supplement that Regulation by the
addition of new non-essential elements, those measures
should be adopted in accordance with the regulatory
procedure with scrutiny provided for in Article 5a of
Decision 1999/468/EC.

(18)

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

HAVE ADOPTED THIS REGULATION:

Article 1

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

1) the following recital shall be inserted:

‘(8a)

to

of

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
the Council of 3
European Parliament and of
October
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.

health

laying

down

2002

animals in a way that respects the particularities
of each species. Pursuant
to the precautionary
principle and in keeping with the natural diet and
living conditions of ruminants,
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.

it

(11b)

is obtained by
Mechanically separated meat
removing meat from bones in such a way that the
muscle fibre structure is destroyed or modified. It
can contain parts of the bones and the perios-
teum (bone skin). Thus, mechanically separated
meat is not comparable with regular meat. Conse-
quently 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: the screening methods listed in Annex
for which the results are known within 24

X,
hours;’;

(b) the following points shall be added:

‘(n) mechanically

the
separated meat or
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.’;

(*) 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).’;

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-
and-mouth disease
increasingly
crisis
the best way to ensure
become accepted that
human and animal health is to keep and nourish

it has

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

— negligible BSE risk as defined in Annex II,

— controlled BSE risk as defined in Annex II,

— undetermined BSE risk as defined in Annex II.

L 404/4

EN

Official Journal of the European Union

30.12.2006

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 potential factors
for the appearance of bovine spongiform encephalo-
pathy 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 information
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 referred to in Article 24
(3) and listed in Annex X.’;

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.

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

At the request of a Member State which can demon-
strate the improvement of the epidemiological situation
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.

to determine

The Member State concerned shall provide proof of its
capability
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:

The annual monitoring programme referred to
‘1a.
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 scientific
evidence corroborating the resistance to TSE of particular
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).

30.12.2006

EN

Official Journal of the European Union

L 404/5

3. Member States which introduce breeding programmes
shall submit regular reports to the Commission in order to
enable the programmes to be scientifically evaluated, in par-
ticular with regard to their impact on the incidence of TSEs
but also on genetic diversity and variability 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
those
programmes shall be amended accordingly.’;

and where necessary,

evaluated regularly,

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 from

‘1.
animals shall be prohibited.

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

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 scien-
tific assessment of the dietary needs of young rumi-
nants and subject to the rules adopted for the imple-
mentation of this Article provided for in paragraph 5
of
the
this Article, and following an assessment of
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
feed
contains protein derived from mammals or
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
in Article 24(2) may be taken,
following detailed
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:

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

for

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

‘5.
Rules for the implementation of this Article, in
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 of
the Commission covering sourcing, processing, 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.

2.
Paragraph 1 of this Article shall not apply to tissues
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

thereof, with a
3.
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-
the occurrence of a TSE in the relevant age
ability of
the Community's bovine, ovine and caprine
groups of
population.

L 404/6

EN

Official Journal of the European Union

30.12.2006

Rules providing for exemptions from paragraphs 1 to
5.
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 terri-
tory. 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:

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

examination carried out by the

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 movement
restriction until the results of the examination are avail-
able.
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 unli-
kely 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
depending on the epidemiological
information avail-
able.

In accordance with the procedure referred to in Article
24(2) and by way of derogation from the official move-
ment restrictions provided for in this paragraph, a
Member State may be exempted from implementing
such restrictions if it applies measures offering equiva-
lent safeguards based on an appropriate assessment 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 paragraph
shall be killed and disposed of in accordance with
Regulation (EC) No 1774/2002.’;

(c) after the first subparagraph, the following subparagraph

shall be inserted:

‘At the request of a Member State and based on a
favourable risk assessment
taking particularly into
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.

4.
Rules for implementing this Article may be adopted
in accordance with the procedure referred to in Article 24
(2).’;

30.12.2006

EN

Official Journal of the European Union

L 404/7

13) Article 16 is hereby amended as follows:

(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).

3.
Food products of animal origin containing mate-
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 effectively
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 Regu-
lation.’;

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

(e) criteria for granting exemptions from the restrictions

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 from the requirement to
remove and destroy specified risk material as referred
to in Article 8(5),

(i) approval of 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).’

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
in the case of safeguard
shall be three months and,
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:

14) the following Article shall be inserted:

‘Article 24a

‘Article 23a

The following measures which are designed to amend non-
essential elements of this Regulation, including by supple-
menting it, shall be adopted in accordance with the regula-
tory 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),

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 scien-
tific evidence, maintain, or if scientifically justified increase,
the level of protection of human and animal health ensured
in the Community.’.

Article 2

(c) criteria to demonstrate improvement of the epidemiolo-

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

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

L 404/8

EN

Official Journal of the European Union

30.12.2006

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

Done at Brussels, 18 December 2006.

For the European Parliament

The President

J. BORRELL FONTELLES

For the Council

The President

J.-E. ENESTAM