Commission Regulation (EC) No 553/2008 of 17 June 2008 amending Annex VII to 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 (Text with EEA relevance)
Date: 2008-06-17
Institutions: European Commission
Subjects: animal disease, disease prevention, health control, public health, veterinary inspection, veterinary legislation

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COMMISSION REGULATION (EC) No 553/2008

of 17 June 2008

amending Annex VII to Regulation (EC) No 999/2001 of the European Parliament and of the
laying down rules for the prevention, control and eradication of certain transmissible
Council

spongiform encephalopathies

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Regulation (EC) No 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 encephalopathies (1), and in particular
Article 23 thereof,

Whereas:

(1)

(2)

(3)

(4)

Regulation (EC) No 999/2001 lays down rules for the
monitoring of transmissible spongiform encephalopathies
in bovine, ovine and caprine animals and for eradication
measures to be carried out following confirmation of a
transmissible spongiform encephalopathy (TSE) in ovine
and caprine animals.

Annex VII to Regulation (EC) No 999/2001 lays down
following
the eradication measures to be carried out
confirmation of an outbreak of TSE in ovine and
caprine animals.

Although TSE has been known to be present in ovine
and caprine animals for over two hundred years, there is
no evidence of any relationship between outbreaks of
TSE in those animals and outbreaks of TSE in humans.
in 2000 the Commission introduced a
Nevertheless,
comprehensive set of measures
the monitoring,
prevention, control and eradication of TSE in ovine
and caprine animals, on the basis of the limited scientific
knowledge available at that time, and in order to ensure
that sourcing from ovine and caprine animals’ materials
is as safe as possible.

for

Those measures are aimed at gathering as much data as
possible on the prevalence of TSE other than bovine
spongiform encephalopathy (BSE) in ovine and caprine
animals, and on possible links with BSE and transmissi-
bility to humans. The measures are also aimed at
reducing as much as possible the occurrence of TSE.

(5)

(6)

specified risk
include the removal of
The measures
materials, an extensive active monitoring programme,
measures applicable to flocks infected with TSE and
voluntary breeding schemes to increase resistance to
TSE in the ovine population. Since the introduction of
such measures and with the information obtained from
active
in the
Member States, no epidemiological
link has ever been
established between TSE, other than BSE, in ovine and
caprine animals and TSE in humans.

surveillance programmes

carried out

the

laying

general

principles

Article 7 of Regulation (EC) No 178/2002 of
the
European Parliament and of the Council of 28 January
down
2002
and
requirements of
food law, establishing the European
Food Safety Authority and laying down procedures in
matters of food safety (2) provides that in specific circum-
stances where, following an assessment of available infor-
mation, the possibility of harmful effects on health is
identified but scientific uncertainty persists, provisional
risk management measures necessary to ensure a high
level of health protection may be adopted, pending
further scientific information for a more comprehensive
risk assessment.
It also stipulates that such measures
must be proportionate and no more restrictive of trade
than is required to achieve the high level of health
protection sought, regard being had to technical and
economic
regarded as
legitimate
consideration. The
measures are to be reviewed within a reasonable period
of time.

feasibility and other
in the matter under

factors

is the only TSE agent

On 8 March 2007 the European Food Safety Authority
(EFSA) adopted an opinion on certain aspects related to
the risk of TSE in ovine and caprine animals (3). In that
opinion, EFSA concluded that ‘there is no evidence for an
epidemiological or molecular
link between classical
and/or atypical scrapie and TSEs in humans. The BSE
identified as zoonotic.
agent
However,
in view of their diversity it is currently not
possible to exclude transmissibility to humans of other
animal TSE agents’. It also concluded that ‘current discri-
minatory tests as described in the Community legislation
to be used for discrimination between scrapie and BSE
appear, up to now, to be reliable for the differentiation of
BSE from classical and atypical scrapie. However, at the
current stage of scientific knowledge, neither their diag-
nostic sensitivity nor their specificity can be assumed to
be perfect’.

(1) OJ L 147, 31.5.2001, p. 1. Regulation as

last amended by
Commission Regulation (EC) No 357/2008 (OJ L 111, 23.4.2008,
p. 3).

(2) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission

Regulation (EC) No 202/2008 (OJ L 60, 5.3.2008, p. 17).

(3) The EFSA Journal (2007), 466, 1-10.

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(7)

(8)

(9)

the

to Regulation

amendments made

Following that opinion and in the framework of the
Communication from the Commission — TSE Road
map of 15 July 2005 (1), and in line with the SANCO
work programme 2006-07 on TSEs of 21 November
2006 (2), Commission Regulation (EC) No 727/2007 of
26 June 2007 amending Annexes I, III, VII and X to
Regulation (EC) No 999/2001 of
European
Parliament and of the Council
laying down rules for
the prevention, control and eradication of certain trans-
missible spongiform encephalopathies (3) was adopted.
The
(EC) No
999/2001 by Regulation (EC) No 727/2007 were
initially taken as
aimed at adjusting the measures
regards TSE in ovine and caprine animals,
to take
account of updated scientific evidence. Regulation (EC)
No 999/2001, as amended by Regulation (EC) No
727/2007, therefore discontinued the obligation to cull
the entire flock and provided for certain alternative
measures to culling in the event of confirmation of an
outbreak of TSE in a holding of ovine or caprine animals
and where the presence of bovine spongiform encepha-
lopathy (BSE) had been excluded.
In particular, taking
into account
the sector for ovine and
caprine animals is different across the Community, Regu-
lation (EC) No 999/2001, as amended by Regulation (EC)
No 727/2007,
introduced the possibility for Member
States to apply alternative policies, as laid down in Regu-
lation (EC) No 727/2007, depending on the specific
characteristics of the sector in each Member State.

the fact

that

On 17 July 2007, in Case T-257/07, France brought an
action against
the European Commission before the
Court of First Instance of the European Communities,
applying for the partial annulment of point 2.3(b)(iii),
point 2.3(d) and point 4 of Chapter A of Annex VII to
Regulation (EC) No 999/2001, as amended by Regulation
(EC) No 727/2007, in particular regarding the measures
to be applied to TSE-affected flocks, or alternatively the
entire annulment of
In its Order of
28 September 2007 (4), the Court suspended the appli-
cation of those provisions pending delivery of a final
judgment.

that Regulation.

In the Order of 28 September 2007, the Commission’s
assessment of the available scientific data on the possible
risks was questioned. Accordingly,
the Commission
subsequently asked EFSA to assist it in clarifying the
two main premises on which Regulation (EC) No
727/2007 was based. Firstly, the absence of any scientific
evidence demonstrating that any TSE agent, other than
BSE, may be considered to be a zoonotic agent. Secondly,
the possibility to distinguish through molecular and
biological tests between BSE and other animal TSE in
ovine and caprine animals. On 24 January 2008, EFSA
adopted the scientific and technical clarification (5), as

(1) COM(2005) 322 final.
(2) SEC(2006) 1527.
(3) OJ L 165, 27.6.2007, p. 8.
(4) OJ C 283, 24.11.2007, p. 28.
(5) Scientific Report of the Panel on Biological Hazards on a request
from the European Commission on ‘Scientific and technical clarifi-
cation in the interpretation and consideration of some facets of the
conclusions of its Opinion of 8 March 2007 on certain aspects
related to the risk of Transmissible Spongiform Encephalopathies
in ovine and caprine animals’. The EFSA Journal
(TSEs)
(2008),
626, 1-11.

the

interpretation of

the
some
regards
conclusions of
its Opinion of 8 March 2007, which
had been taken into account for the adoption of Regu-
lation (EC) No 727/2007.

facets of

(10) As regards the transmissibility of TSE, EFSA confirmed

that:

— in ovine animals, no TSE agents other than those
causing Classical Scrapie and Atypical Scrapie have
been identified,

— in caprine animals, no TSE agents other than those
causing BSE, Classical Scrapie and Atypical Scrapie
have been identified,

— the operational term ‘BSE’ covers a TSE of bovine
three
animals
that could be caused by at
distinct TSE agents with heterogeneous biological
properties,

least

— the operational term ‘Classical Scrapie’ covers a TSE
of ovine and caprine animals caused by several TSE
agents with heterogeneous biological properties,

— the operational term ‘Atypical Scrapie’ covers a TSE
of ovine and caprine animals
from
Classical Scrapie. Currently, it is a subject for debate
whether it is caused by one or more TSE agents.

that differs

(11) However, EFSA cannot

exclude

transmissibility

to

humans of other TSE agents other than BSE as:

— experimental

to primate

transmissions

to
transgenic mouse models expressing the human PrP
gene are currently used to evaluate the potential
capacity of a TSE agent to cross the human species
barrier,

and

— TSE agents other than the Classical BSE agent from
three field TSE cases (two Classical Scrapie cases and
one L type BSE case) have been demonstrated to
cross the modelled human species barrier,

— some

limitations

to be
to these models have
including the uncertainty of how well
considered,
they represent
the human species barrier and the
uncertainty of how well the experimental inoculation
route employed represents exposure under natural
conditions.

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(12)

that

It appears from EFSA’s clarifications that the biodiversity
of the disease agents in ovine and caprine animals is an
important element which does not make it possible to
exclude transmissibility to humans and that that diversity
increases the likelihood of one of the TSE agents being
transmissible. However, EFSA acknowledges that there is
no scientific evidence of any direct link between TSE in
ovine and caprine animals, other than BSE, and TSE in
humans. The EFSA viewpoint
transmissibility to
humans of TSE agents in ovine or caprine animals
cannot be excluded is based on experimental studies on
human species barrier and animal models (primates and
mice). Those models, however, do not take into account
genetic characteristics of humans which have a major
influence on relative susceptibility to prion diseases.
They also have limitations when extrapolating results to
natural conditions, in particular regarding how well they
represent the human species barrier and the uncertainty
of how well the experimental inoculation route employed
represents exposure under natural conditions. On that
basis, it may be considered that although a risk of trans-
missibility to humans of TSE agents in ovine or caprine
animals cannot be excluded, that risk would be extremely
low, taking into account the fact that the evidence of
transmissibility is based on experimental models which
do not represent the natural conditions related to the real
human species barrier and the real routes of infection.

(13) As regards the discriminatory tests, EFSA confirmed that:

— based on the limited data available, the discriminatory
tests as implemented at European Union level are
practicable tools for screening of field TSE cases, as
referred to in point 3.2(c) of Chapter C of Annex X
to Regulation (EC) No 999/2001,
fulfilling the
objective of rapid and reproducible identification of
TSE cases that have a signature compatible with
Classical BSE agent,

— those discriminatory tests cannot be considered to be
perfect because of the current lack of understanding
of both the true biodiversity of TSE agents in ovine
and caprine animals and how the agents interact in
case of co-infection.

(14)

Following a request by the Commission for clarification
as to whether the absence of statistically sufficient data
on the performance of the tests is compensated by the
procedure in place, which includes a ring trial with ad-
ditional molecular testing methods in different labora-
tories and an evaluation by an expert panel chaired by
the Community Reference Laboratory for TSEs, EFSA
explained that:

(15)

(16)

cases, there is uncertainty on about their performance
in the field because of the lack of detection of natural
BSE in ovine or caprine animals,

— TSE positive cases go through the full discriminatory
including bioassay, only when biochemical
compatible with BSE
therefore, data obtained through this
the
the discriminatory

process,
discriminatory
signature;
process cannot be used for the evaluation of
sensitivity or the specificity of
tests,

testing

is

— increasing the number of negative results during TSE
discriminatory testing of ovine or caprine animals
cannot compensate for the absence of statistically
sufficient data on the performance of the tests.

a

that have

EFSA acknowledged that the discriminatory tests estab-
lished in Regulation (EC) No 999/2001 are practicable
tools fulfilling the objective of rapid and reproducible
identification of TSE cases
signature
compatible with the classical BSE agent. Given the
absence of scientific evidence of co-infection of BSE
and other TSE agents in ovine or caprine animals in
natural conditions, and given that
the prevalence of
BSE in ovine, if present, or caprine animals is very low
and therefore the possibility of co-infection would be
even lower, the number of BSE cases missed in ovine
and
low.
Therefore, although the discriminatory tests cannot be
considered to be perfect,
it is appropriate to consider
for the purposes of the TSE
them as a suitable tool
eradication objectives pursued by Regulation (EC) No
999/2001.

animals would

extremely

caprine

be

In its Opinion of 25 January 2007 (1), EFSA gave an
the likely prevalence of BSE in ovine
estimation of
animals. The Authority concluded that
in high-risk
countries there is a rate of less than 0,3 to 0,5 cases
of BSE per 10 000 healthy slaughtered animals. EFSA
also stated that in the European Union ‘there is a 95 %
confidence that the number of cases is equal to or below
four cases per million sheep; at a 99 % confidence level,
the number becomes equal to or below six cases per
million. Since no BSE case has yet to be confirmed in
sheep, the most likely prevalence is zero’. Since the intro-
duction in 2005 of the discriminatory tests procedure, as
set out in point 3.2(c) of Chapter C of Annex X to
Regulation (EC) No 999/2001, 2 798 discriminatory
tests have been carried out
in TSE-affected ovine
animals and 265 discriminatory tests have been carried
out in TSE-affected caprine animals and none of them
have been confirmed as BSE-like.

— despite

trials
employing samples from experimental ovine BSE

performance

consistent

ring

in

(1) Opinion of the Scientific Panel on Biological Hazards on a request
from the European Commission on the quantitative risk assessment
on the residual BSE risk in sheep meat and meat products, The EFSA
Journal (2007) 442, 1-44.

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in

the

pursuit

of Community

(17) A high level of protection of human life and health is
assured
policies.
Community measures governing food and feed must be
based on an appropriate assessment of the possible risks
taking into
for human and animal health and must,
account existing scientific evidence, maintain or, if scien-
tifically justified,
increase the level of protection of
human and animal health. It is impossible, however, to
consider the complete elimination of risk as a realistic
objective for any risk management decision in matters
regarding food safety, where the cost and benefits of risk-
reducing measures have to be carefully weighed in order
to ensure the measure’s proportionality. It is the role and
the
responsibility of
the
risk,
acceptable level of
elements present in a scientific risk assessment.

to decide
taking into account all

risk manager

the

(20)

(21)

(22)

appropriate to the level of risk involved and dispropor-
tionate to the objective pursued.

The measures laid down in Annex VII to Regulation (EC)
No 999/2001 should therefore be amended in order to
make it possible for Member States to dispense with the
requirement of total or partial herd culling if a TSE case
is detected in ovine or caprine animals.

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

The measures provided for in this Regulation are in
accordance with
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

(18)

The Commission, in its role as risk manager on EU level,
is responsible for establishing the acceptable level of risk
and adopting measures that are the most appropriate for
maintaining a high level of protection of public health. It
has reviewed and assessed the most recent scientific
information as regards the transmissibility of TSE to
is present as
humans.
being currently very low.

It has assessed any risk that

(19)

The measures set out in Annex VII to Regulation (EC) No
999/2001 should therefore be reassessed in order to
impose a burden on the
ensure that
they do not
is not
Member States and economic operators

that

HAS ADOPTED THIS REGULATION:

Article 1

Annex VII to Regulation (EC) No 999/2001 is amended in
accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the 60th day following
the European
that of
Union.

its publication in the Official

Journal of

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

Done at Brussels, 17 June 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

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ANNEX

In Annex VII to Regulation (EC) No 999/2001, Chapter A is replaced by the following:

‘CHAPTER A

Measures following confirmation of the presence of a TSE

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, its progeny born within two years prior to, or after,

clinical onset of the disease,

— all animals of the cohort of the animal in which the disease was confirmed,

— the possible origin of the disease,

— other animals 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 trans-

mission, 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,

— insofar as they are identifiable, the parents, and in the case of females all embryos, ova and the last progeny

of the female 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 referred to in the second indent,

— 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,

— the movement of potentially contaminated feedingstuffs, other material or any other means of transmission,

which may have transmitted the TSE agent to or from the holding in question.

2.

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

2.1. In the case of confirmation of BSE in a bovine animal, the killing and complete destruction of bovine animals
identified by the inquiry referred to in the second and third indents of point 1(a); however, the Member State may
decide:

— not to kill and destroy animals of the cohort referred to in the third indent of point 1(a) if evidence has been

provided that such animals did not have access to the same feed as the affected animal,

— to defer the killing and destruction of animals in the cohort referred to in the third indent of point 1(a) until the
end of their productive life, provided that they are bulls continuously kept at a semen collection centre and it can
be ensured that they are completely destroyed following death.

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2.2. If a TSE is suspected in an ovine or caprine animal on a holding in a Member State, all other ovine and caprine
animals from that holding shall be placed under official movement restriction until the results of the examination are
available. If there is evidence that the holding where the animal was present when the TSE was suspected is not likely
to be the holding where the animal could have been exposed to a TSE, the competent authority may decide that
other holdings or only the holding of exposure shall be placed under official control depending on the epidemio-
logical information available.

2.3. In the case of confirmation of TSE in an ovine or caprine animal:

(a)

if BSE cannot be excluded after the results of a ring trial carried out in accordance with the procedure set out in
Annex X, Chapter C, point 3.2(c), the killing and complete destruction of all animals, embryos and ova identified
by the inquiry referred to in the second to fifth indents of point 1(b);

(b) if BSE is excluded in accordance with the procedure set out in Annex X, Chapter C, point 3.2(c), pursuant to the

decision of the competent authority:

either

(i) the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in
the second and third indents of point 1(b). The conditions set out in point 3 shall apply to the holding;

or

(ii) the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in

the second and third indents of point 1(b), with the exception of:

— breeding rams of the ARR/ARR genotype,

— breeding ewes carrying at least one ARR allele and no VRQ allele and, where such breeding ewes are
their genotype meets the

the lambs subsequently born,

the inquiry,

if

pregnant at
requirements of this subparagraph,

the time of

— sheep carrying at least one ARR allele which are intended solely for slaughter,

— if the competent authority so decides, sheep and goats less than three months old which are intended

solely for slaughter.

The conditions set out in point 3 shall apply to the holding;

or

(iii) a Member State may decide not to kill and destroy the animals, identified by the inquiry referred to in the
second and third indents of point 1(b) where it is difficult to obtain replacement ovine animals of a known
genotype or where the frequency of the ARR allele within the breed or holding is low, or where it is deemed
necessary in order to avoid inbreeding, or based on a reasoned consideration of all the epidemiological
factors. The conditions set out in point 4 shall apply to the holding;

(c) by way of derogation from the measures set out in point (b), and only where the TSE case confirmed on a
holding is an atypical scrapie case, the Member State may decide to apply the measures laid down in point 5;

(d) Member States may decide:

(i) to replace the killing and complete destruction of all animals referred to in b(i) by slaughtering for human

consumption;

(ii) to replace the killing and complete destruction of animals referred to in b(ii) by slaughtering for human

consumption provided that:

— the animals are slaughtered within the territory of the concerned Member State,

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— all animals which are over 18 months of age or have more than two permanent incisors erupted through
the gum and are slaughtered for human consumption shall be tested for the presence of TSE in
accordance with the laboratory methods set out in Annex X, Chapter C, point 3.2 (b);

(e)

the prion protein genotype of ovine animals, up to a maximum of 50, killed and destroyed or slaughtered for
human consumption in accordance with points (b)(i) and (iii) shall be determined;

(f) where the frequency of the ARR allele within the breed or holding is low, or where it is deemed necessary in
order to avoid inbreeding, a Member State may decide to delay the destruction of animals as referred to in point
2.3 (b)(i) and (ii) for up to five breeding years.

2.4. If the infected animal has been introduced from another holding, a Member State may decide, based on the history
of the case, to apply eradication measures in the holding of origin in addition to, or instead of, the holding in which
the infection was confirmed; in the case of land used for common grazing by more than one flock, Member States
may decide to limit the application of those measures to a single flock, based on a reasoned consideration of all the
epidemiological factors; where more than one flock is kept on a single holding, Member States may decide to limit
the application of the measures to the flock in which the TSE has been confirmed, provided it has been verified that
the flocks have been kept isolated from each other and that the spread of infection between the flocks through either
direct or indirect contact is unlikely.

3.

Following the application on a holding of the measures referred to in point 2.3 (a) and (b)(i) and (ii):

3.1. Only the following animals may be introduced to the holding(s):

(a) male sheep of the ARR/ARR genotype;

(b) female sheep carrying at least one ARR allele and no VRQ allele;

(c) caprine animals, provided that:

(i) no ovine animals for breeding other than those of the genotypes referred to in points (a) and (b) are present

on the holding;

(ii) thorough cleaning and disinfection of all animal housing on the premises has been carried out following

destocking.

3.2. Only the following ovine germinal products may be used in the holding(s):

(a) semen from rams of the ARR/ARR genotype;

(b) embryos carrying at least one ARR allele and no VRQ allele.

3.3. Movement of the animals from the holding shall be subject to the following conditions:

(a) movement of ARR/ARR sheep from the holding shall not be subject to any restriction;

(b) sheep carrying only one ARR allele may be moved from the holding only to go directly for slaughter for human

consumption or for the purposes of destruction; however,

— ewes carrying one ARR allele and no VRQ allele may be moved to other holdings which are restricted

following the application of measures in accordance with point 2.3 (b)(ii) or 4,

— if the competent authority so decides, lambs and kids may be moved to one other holding solely for the
purposes of fattening prior to slaughter; the holding of destination shall not contain any ovine or caprine
animals other than those being fattened prior to slaughter, and shall not dispatch live ovine or caprine
animals to other holdings, except for direct slaughter within the territory of the concerned Member State;

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(c) caprine animals may be moved provided that the holding is subjected to intensified TSE monitoring, including

the testing of all caprine animals which are over the age of 18 months and:

(i) are slaughtered for human consumption at the end of their productive lives; or

(ii) have died or been killed on the holding, and meet the conditions set out to in Annex III, Chapter A, Part II,

point 3;

(d) if the Member State so decides, lambs and kids less than three months old may be moved from the holding to

go directly for slaughter for human consumption.

3.4. The restrictions set out in points 3.1, 3.2 and 3.3 shall continue to apply to the holding for a period of two years

from:

(a) the date of attainment of ARR/ARR status by all ovine animals on the holding; or

(b) the last date when any ovine or caprine animal was kept on the premises; or

(c)

the date when the intensified TSE monitoring set out in 3.3 (c) commenced; or

(d) the date when all breeding rams on the holding are of ARR/ARR genotype and all breeding ewes carry at least
one ARR allele and no VRQ allele, provided that during the two-year period, negative results are obtained from
TSE testing of the following animals over the age of 18 months:

— an annual sample of ovine animals slaughtered for human consumption at the end of their productive lives
in accordance with the sample size referred to in the Table in Annex III, Chapter A, Part II, point 5, and

— all ovine animals referred to in Annex III, Chapter A, Part II, point 3 which have died or been killed on the

holding.

4.

Following the application on a holding of the measures set out in point 2.3 (b)(iii) and for a period of two breeding
years following the detection of the last TSE case:

(a) all ovine and caprine animals on the holding shall be identified;

(b) all ovine and caprine animals on the holding, may be moved only within the territory of the concerned Member
State for slaughter for human consumption or for the purposes of destruction; all animals over the age of 18
months slaughtered for human consumption shall be tested for the presence of TSE in accordance with the
laboratory methods laid down in Annex X, Chapter C, point 3.2(b);

(c)

the competent authority shall ensure that embryos and ova are not dispatched from the holding;

(d) only the semen from rams of the ARR/ARR genotype and embryos carrying at least one ARR allele and no VRQ

allele may be used in the holding;

(e) all ovine and caprine animals which are over the age of 18 months which have died or been killed on the

holding shall be subject to TSE testing;

(f) only male sheep of the ARR/ARR genotype and female ovine animals from holdings where no TSE cases have
been detected or from flocks fulfilling the conditions set out in point 3.4 may be introduced in the holding;

(g) only caprine animals from holdings where no TSE cases have been detected or from flocks fulfilling the

conditions of point 3.4 may be introduced in the holding;

(h) all ovine and caprine animals in the holding shall be subject to common grazing restrictions to be determined by

the competent authority, based on a reasoned consideration of all the epidemiological factors;

18.6.2008

EN

Official Journal of the European Union

L 158/13

(i) by way of derogation of point (b) if the competent authority so decides, lambs and kids may be moved to
another holding within the same Member State solely for the purposes of fattening prior to slaughter; provided
that the holding of destination shall not contain any ovine or caprine animals other than those being fattened
prior to slaughter, and shall not dispatch live ovine or caprine animals to other holdings, except for direct
slaughter within the territory of the concerned Member State.

5.

Following the application of the derogation provided for in point 2.3 (c) the following measures shall apply:

(a) either the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to
in the second and third indents of point 1(b). Member States may decide to determine the prion protein
genotype of ovine animals which have been killed and destroyed;

(b) or, for a period of two breeding years following the detection of the last TSE case, at least the following

measures:

(i) all ovine and caprine animals in the holding shall be identified;

(ii) the holding must be subject to intensified TSE monitoring for a period of two years, including the testing of
all ovine and caprine animals which are over the age of 18 months and slaughtered for human consumption
and all ovine and caprine animals over the age of 18 which have died or been killed on the holding;

(iii) the competent authority shall ensure that live ovine and caprine animals, embryos and ova from the holding

are not dispatched to other Member States or third countries.

6. Member States applying the measures set out in point 2.3(b)(iii) or the derogations provided for in points 2.3(c) and
(d) shall notify to the Commission an account of the conditions and criteria used for granting them. Where
additional TSE cases are detected in flocks where derogations are applied, the conditions for granting such dero-
gations shall be reassessed.’