Commission Regulation (EC) No 722/2007 of 25 June 2007 amending Annexes II, V, VI, VIII, IX and XI 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: 2007-06-25
Institutions: European Commission
Subjects: EU control, animal product, bovine spongiform encephalopathy, disease prevention, health control, infectious disease, live animal

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COMMISSION REGULATION (EC) No 722/2007

of 25 June 2007

amending Annexes II, V, VI, VIII, IX and XI 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)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

procedure for the classification of countries according to
their BSE risk based on three categories was adopted.

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)

Regulation (EC) No 999/2001 lays down rules for the
prevention, control and eradication of transmissible ence-
phalopathies
to the
in animals.
production and placing on the market of live animals
and products of animal origin and in certain specific
cases to exports thereof.

applies

(TSEs)

It

Article 5 of Regulation (EC) No 999/2001 provides that
the bovine spongiform encephalopthy (BSE) status of
Member States or third countries or regions thereof
is to be determined by classifi-
(countries or regions)
cation into one of three categories. Annex II to that
Regulation lays down rules for the determination of the
that
BSE status of countries or regions. Article 5 of
Regulation also provides
the
for a reassessment of
Community categorisation of countries following the
establishment by the World Organisation for Animal
health (OIE) of a procedure for the classification of
countries by category.

(3)

Annex V to Regulation (EC) No 999/2001 lays down the
rules for the collection and disposal of specified risk
materials and Annex IX to that Regulation lays down
the rules for the importation into the Community of
live animals, embryos, ova and products of animal origin.

(4)

During the General Session of the World Organisation
for Animal health (OIE) in May 2005, a new simplified

(1) OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Regu-

lation (EC) No 1923/2006 (OJ L 404, 30.12.2006, p. 1).

(5)

(6)

(7)

(8)

(9)

Regulation (EC) No 999/2001 was amended by Regu-
lation (EC) No 1923/2006 in order to transpose that
new simplified categorisation system into Community
legislation. Following that amendment, Annexes II, V
and IX to Regulation (EC) No 999/2001 should be
amended to take account of
the new categorisation
system.

In the absence of a decision on the classification of
countries in accordance with Article 5(2) or (4) of Regu-
lation (EC) No 999/2001, the provisions in Article 9 and
Annex VI did not apply. In view of the fact that the new
categorisation system is to apply from 1 July 2007 and
in order to align this Annex with the rules applicable
the transitional measures based on scientific
under
to the
evidence
Articles, Annex VI should be amended.

amendments made

and with the

Annex VIII to Regulation (EC) No 999/2001 lays down
the conditions for the placing on the market and export
of live animals, their semen, embryos, ova and products
of animal origin. Chapter C of that Annex lays down the
conditions for intra-Community trade in certain products
of animal origin. Those conditions should be amended to
take into account of the new categorisation system.

Point 5 of Part D of Annex XI
to Regulation (EC)
No 999/2001 lays down measures concerning intra-
Community trade of bovine animals born or reared on
the United Kingdom before 1 August 1996 and impor-
tation into the Community of meat products derived
from cervid animals. For human and animal health
protection reasons, these measures should continue to
apply after 1 July 2007.

For clarity and consistency reasons the provisions for
intra-Community trade and export to third countries of
bovine animals born or reared on the United Kingdom
before 1 August 1996 should be laid down in Annex
VIII and the provisions for importation of meat products
derived from cervid animals should be laid down in
Annex IX.

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(10)

transitional measures

concerning specified risk
The
material contained in Annex XI to Regulation (EC) No
999/2001 should cease to apply with respect to each
country or region immediately following the date of
adoption of a decision on classification of that country
or region. Annex XI should therefore be repealed.

(11)

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

(12)

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

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

Article 1

Annexes II, V, VI, VIII,
to Regulation (EC) No
IX and XI
999/2001 are amended in accordance with the Annex to this
Regulation.

Article 2

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

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

Done at Brussels, 25 June 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

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ANNEX

Annexes II, V, VI, VIII, IX and XI to Regulation (EC) No 999/2001 are amended as follows:

(1) Annex II to Regulation (EC) No 999/2001 is replaced by the following:

‘ANNEX II

DETERMINATION OF BSE STATUS

CHAPTER A

Criteria

The BSE status of Member States or third countries or regions thereof (hereinafter referred to as countries or regions),
shall be determined on the basis of the criteria set out in points (a) to (e).

In the country or region:

(a) a risk analysis in accordance with the provisions of Chapter B,

identifying all the potential factors for BSE

occurrence and their historic perspective in the country or region, is carried out;

(b) a system of continuous surveillance and monitoring of BSE relating in particular to the risks described in Chapter

B and complying with the minimal surveillance requirements laid down in Chapter D is in place;

(c) an on-going awareness programme for veterinarians, farmers, and workers involved in transportation, marketing
and slaughter of bovine animals, to encourage reporting of all cases showing clinical signs consistent with BSE in
target sub-populations as defined in Chapter D of this Annex is in place;

(d) an obligation to notify and investigate all bovine animals showing clinical signs consistent with BSE is in force;

(e)

the examination of brain or other tissues collected within the framework of the surveillance and monitoring
system referred to in point (b) is carried out in an approved laboratory.

CHAPTER B

Risk analysis

1.

Structure of the risk analysis

The risk analyses shall comprise a release assessment and an exposure assessment.

2.

Release assessment (external challenge)

2.1. The release assessment shall consist of assessing the likelihood that the BSE agent has either been introduced
into the country or region via commodities potentially contaminated with a BSE agent, or is already present in
the country or region.

The following risk factors shall be taken into account:

(a)

the presence or absence of the BSE agent in the country or region and, if the agent is present, its prevalence
based on the outcome of surveillance activities;

(b) the production of meat-and-bone meal or greaves from the BSE indigenous ruminant population;

(c)

imported meat-and-bone meal or greaves;

(d) imported bovine and ovine and caprine animals;

(e)

imported animal feed and feed ingredients;

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(f)

imported products of ruminant origin for human consumption, which may have contained tissues listed in
point 1 of Annex V and may have been fed to bovine animals;

(g)

imported products of ruminant origin for in vivo use in bovine animals.

2.2. Special eradication schemes, surveillance and other epidemiological investigations (especially surveillance for BSE
conducted on the bovine animals population) relevant to the risk factors listed in point 2.1 should be taken into
account in carrying out the release assessment.

3.

Exposure assessment

The exposure assessment shall consist of assessing the likelihood of exposure of bovine animals to the BSE
agent, through a consideration of the following:

(a) recycling and amplification of the BSE agent through consumption by bovine animals of meat-and-bone

meal or greaves of ruminant origin, or other feed or feed ingredients contaminated with these;

(b) the use of ruminant carcasses (including from fallen stock), by-products and slaughterhouse waste, the

parameters of the rendering processes and the methods of animal feed manufacture;

(c)

the feeding or not of ruminants with meat-and-bone meal and greaves derived from ruminants, including
measures to prevent cross-contamination of animal feed;

(d) the level of surveillance for BSE conducted on the bovine animals population to that time and the results of

that surveillance.

CHAPTER C

Definition of categories

I. COUNTRY OR REGION WITH A NEGLIGIBLE BSE RISK

A country or region:

(1) where a risk analysis in accordance with Chapter B has been conducted in order to identify the historical and

existing risk factors;

(2) which has demonstrated that appropriate specific measures have been taken for the relevant period of time

defined below to manage each identified risk;

(3) which has demonstrated that Type B surveillance, in accordance with Chapter D, is in place, and the relevant

points target, in accordance with Table 2 thereof, has been met; and

(4) which is:

(a) either in the following situation:

(i) in the country or region there has been no case of BSE, or, any case of BSE has been demonstrated to

have been imported and has been completely destroyed;

(ii) the criteria in points (c), (d) and (e) of Chapter A of this Annex have been complied with for at least

seven years; and

(iii) it has been demonstrated through an appropriate level of control and audit that for at least eight
years neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants;

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(b) or in the following situation:

(i) there has been one or more BSE indigenous cases in the country or region but every BSE indigenous

case was born more than 11 years ago;

(ii) the criteria in points (c), (d) and (e) of Chapter A have been complied with for at least seven years;

(iii) it has been demonstrated through an appropriate level of control and audit that for at least eight
years neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants;

(iv) the following animals,

if alive in the country or region, are permanently identified, and their

movements controlled, and, when slaughtered or at death, are completely destroyed:

— all BSE cases,

— all bovine animals which, during their first year of life, were reared with the BSE cases during their
first year of life, and which investigation showed consumed the same potentially contaminated
feed during that period, or

— if the results of the investigation referred to in the second indent are inconclusive, all bovine

animals born in the same herd as, and within 12 months of the birth of, the BSE cases.

II. COUNTRY OR REGION WITH A CONTROLLED BSE RISK

A country or region

(1) where a risk analysis based on the information laid down in Chapter B has been conducted in order to

identify the historical and existing risk factors;

(2) which has demonstrated that appropriate measures are been taken to manage all identified risks, but those

measures have not been taken for the relevant period of time;

(3) which has demonstrated that Type A surveillance, in accordance with Chapter D, is in place and the relevant
points target, in accordance with Table 2, has been met. Type B surveillance may replace Type A surveillance
once the relevant points target is met; and

(4) which is:

(a) either in the following situation:

(i) in the country or region there has been no case of BSE, or, any case of BSE has been demonstrated to
have been imported and has been completely destroyed, the criteria in points (c), (d) and (e) of
Chapter A are complied with, and it can be demonstrated through an appropriate level of control and
audit
that neither meat-and-bone meal nor greaves derived from ruminants has been fed to
ruminants;

(ii) the criteria in points (c), (d) and (e) of Chapter A have been complied with for a period shorter than

seven years; and/or

(iii) it cannot be demonstrated that controls over the feeding of meat-and-bone meal or greaves derived

from ruminants to ruminants have been in place for eight years;

(b) or in the following situation:

(i) in the country or region there has been a BSE indigenous case, the criteria in points (c), (d) and (e) of
Chapter A are complied with, and it can be demonstrated through an appropriate level of control and
audit
that neither meat-and-bone meal nor greaves derived from ruminants has been fed to
ruminants;

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(ii) the criteria in points (c) to (e) of Chapter A of this Annex have been complied with for a period

shorter than seven years; and/or

(iii) it cannot be demonstrated that controls over the feeding of meat-and-bone meal or greaves derived

from ruminants to ruminants have been in place for at least eight years;

(iv) the following animals,

if alive in the country or region, are permanently identified, and their

movements controlled, and, when slaughtered or at death, are completely destroyed: and

— all BSE cases, and

— all bovine animals which, during their first year of life, were reared with the BSE cases during their
first year of life, and which investigation showed consumed the same potentially contaminated
feed during that period, or

— if the results of the investigation referred to in the second indent are inconclusive, all bovine

animals born in the same herd as, and within 12 months of the birth of, the BSE cases.

III. COUNTRY OR REGION WITH UNDETERMINED BSE RISK

A country or region for which the determination of BSE status has not been concluded, or which does not meet
the conditions to be fulfilled by the country or region to be classified in one of the other categories.

CHAPTER D

Minimal surveillance requirements

1.

Surveillance types

For the purpose of this Annex, the following definitions shall apply:

(a) Type A surveillance

The application of Type A surveillance will allow the detection of BSE at a design prevalence (1) of at least
one case per 100 000 in the adult bovine animals population in the country or region of concern, at a
confidence level of 95 %;

(b) Type B surveillance

The application of Type B surveillance will allow the detection of BSE at a design prevalence of at least one
case per 50 000 in the adult bovine animals population in the country or region of concern, at a confidence
level of 95 %.

Type B surveillance may be carried out by countries or region of negligible BSE risk status to confirm the
conclusions of the risk analysis, for example by demonstrating the effectiveness of the measures mitigating
any risk factors identified, through surveillance targeted to maximise the likelihood of identifying failures of
such measures.

Type B surveillance may also be carried out by countries or regions of controlled BSE risk status, following
the achievement of the relevant points target using Type A surveillance, to maintain confidence in the
knowledge gained through Type A surveillance.

For the purpose of this Annex, the following four sub-populations of bovine animals have been identified
for surveillance purposes:

(a) bovine animals over 30 months of age displaying behavioural or clinical signs consistent with BSE

(clinical suspects);

___________
(1) Design prevalence is used to determine the size of a testing survey expressed in terms of target points. If the actual prevalence is

greater than the selected design prevalence, the survey is highly likely to detect disease.

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(b) bovine animals over 30 months of age that are non-ambulatory, recumbent, unable to rise or to walk
without assistance; bovine animals over 30 months of age sent for emergency slaughter or with
abnormal observations at ante-mortem inspection (casualty or emergency slaughter);

(c) bovine animals over 30 months of age which are found dead or killed on farm, during transport or at

an abattoir (fallen stock);

(d) bovine animals over 36 months of age at routine slaughter.

2.

Surveillance strategy

2.1. The surveillance strategy shall be designed to ensure that samples are representative of the herd of the country
or region, and include consideration of demographic factors such as production type and geographic location,
and the potential influence of culturally unique husbandry practices. The approach used and the assumptions
made shall be fully documented, and the documentation retained for seven years.

2.2.

In order to implement the surveillance strategy for BSE, a country shall use documented records or reliable
estimates of the age distribution of the adult bovine animals population and the number of bovine animals
tested for BSE stratified by age and by sub-population within the country or region.

3.

Points values and point targets
Surveillance samples must meet the point targets set out in Table 2, on the basis of “point values” fixed in Table
1. All clinical suspects shall be investigated, regardless of the number of points accumulated. A country shall
sample at least three out of the four sub-populations. The total points for samples collected shall be accu-
mulated over a period of a maximum of seven consecutive years to achieve the target number of points. The
total points accumulation shall be periodically compared to the target number of points for a country or region.

Surveillance point values for samples collected from animals in the given sub-population and age
category

Table 1

Routine slaughter (1)

Fallen stock (2)

Casualty slaughter (3)

Clinical suspect (4)

Surveillance sub-population

Age ≥ 1 year and < 2 years

0,01

0,2

0,4

0,1

0,2

0,1

0,0

Age ≥ 2 years and < 4 years (young adult)

0,2

0,4

Age ≥ 4 years and < 7 years (middle adult)

0,9

1,6

Age ≥ 7 years and < 9 years (older adult)

0,4

0,1

Age ≥ 9 years (aged)

0,7

0,2

N/A

260

750

220

45

(1) Bovine animals over 36 months of age at routine slaughter.
(2) Bovine animals over 30 months of age which are found dead or killed on farm, during transport or at an abattoir (fallen

stock).

(3) Bovine animals over 30 months of age that are non-ambulatory, recumbent, unable to rise or to walk without assistance;
bovine animals over 30 months of age sent for emergency slaughter or with abnormal observations at ante-mortem
inspection (casualty or emergency slaughter).

(4) Bovine animals over 30 months of age displaying behavioural or clinical signs consistent with BSE (clinical suspects).

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Table 2

Points targets for different adult bovine animals population sizes in a country or region

Points targets for countries or regions

Adult bovine animals population size
(24 months and older)

Type A surveillance

Type B surveillance

≥ 1 000 000

800 000-1 000 000

600 000-800 000

400 000-600 000

200 000-400 000

100 000-200 000

50 000-100 000

25 000-50 000

300 000

240 000

180 000

120 000

60 000

30 000

15 000

7 500

150 000

120 000

90 000

60 000

30 000

15 000

7 500

3 750

4.

Specific targeting

Within each of the sub-populations above in a country or region, a country may target bovine animals
identifiable as imported from countries or regions where BSE has been detected and bovine animals which
have consumed potentially contaminated feedstuffs from countries or regions where BSE has been detected.

5.

BSE surveillance model

A country may choose to use the full BSurvE model or an alternative method based on the BSurvE model to
estimate its BSE presence/prevalence.

6. Maintenance surveillance

Once the points target has been achieved, and in order to continue to designate the status of a country or
region as controlled BSE risk or negligible risk, surveillance can be reduced to Type B surveillance (provided all
other indicators remain positive). However, to continue to comply with the requirements laid down in this
Chapter, ongoing annual surveillance must continue to include at least three of the four prescribed sub-
populations. In addition all bovine animals clinically suspected of being infected with BSE shall be investigated
regardless of the number of points accumulated. The annual surveillance in a country or region following the
achievement of the required points target, shall be no less than the amount required for one-seventh of its total
Type B surveillancetarget.’

(2) Annex V is replaced by the following:

‘ANNEX V

SPECIFIED RISK MATERIAL

1.

Definition of specified risk material

The following tissues shall be designated as specified risk material if they come from animals whose origin is in
a Member State or third country or of one of their region with a controlled or undetermined BSE risk:

(a) as regards bovine animals:

(i) the skull excluding the mandible and including the brain and eyes, and the spinal cord of animals aged

over 12 months;

(ii) the vertebral column excluding the vertebrae of the tail, the spinous and transverse processes of the
cervical, thoracic and lumbar vertebrae and the median sacral crest and wings of the sacrum, but
including the dorsal root ganglia of animals aged over 24 months; and

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(iii) the tonsils, the intestines from the duodenum to the rectum and the mesentery of animals of all ages.

(b) as regards ovine and caprine animals

(i) the skull including the brain and eyes, the tonsils and the spinal cord of animals aged over 12 months

or which have a permanent incisor erupted through the gum, and

(ii) the spleen and ileum of animals of all ages.

2.

Derogation for Member States

By way of derogation from point 1, tissues listed in that point whose origin is in Member States with a
negligible BSE risk shall continue to be considered as specified risk material.

3.

Marking and disposal

Specified risk material shall be stained with a dye or, as appropriate, otherwise marked,
immediately on
removal, and disposed of in accordance with the provisions laid down in Regulation (EC) No 1774/2002,
and in particular in Article 4(2) thereof.

4.

Removal of specified risk material

4.1.

Specified risk material shall be removed at:

(a) slaughterhouses, or, as appropriate, other places of slaughter;

(b) cutting plants, in the case of vertebral column of bovine animals;

(c) where appropriate, in intermediate plants referred to in Article 10 of Regulation (EC) No 1774/2002 or
(vi) and (vii) of

users and collection centres authorised and registered pursuant to Article 23(2)(c)(iv),
Regulation (EC) No 1774/2002.

4.2. By way of derogation from point 4.1, the use of an alternative test to the removal of specified risk material

may be authorised under the following conditions:

(a)

tests must be carried out in slaughterhouses on all animals eligible for the removal of specified risk
material;

(b) no bovine, ovine or caprine product intended for human food or animal feed may leave the slaughterhouse
before the competent authority has received and accepted the results of the tests on all slaughtered animals
potentially contaminated if BSE has been confirmed in one of them;

(c) when an alternative test gives a positive result, all bovine, ovine and caprine material which has been
potentially contaminated in the slaughterhouse is destroyed in accordance with point 3, unless all parts of
the body including the hide of the affected animal can be identified and kept separate.

4.3. By way of derogation from point 4.1, Member States may decide to allow:

(a)

the removal of spinal cord of ovine and caprine animals in cutting plants specifically authorised for this
purpose;

(b) the removal of bovine vertebral column from carcasses or parts of carcasses in butcher shops specifically

authorised, monitored and registered for this purpose;

(c)

the harvesting of head meat from bovine animals in cutting plants specifically authorised for this purpose
in accordance with the provisions laid down in point 9.

4.4. The rules on removal of specified risk material laid down in this Chapter shall not apply to Category 1 material
as defined in Regulation (EC) No 1774/2002 used under the supervision of competent authorities for feeding
of endangered and protected species of necrophagous birds.

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5.

Measures concerning mechanically separated meat

Notwithstanding the individual decisions referred to in Article 5(2), and by way of derogation from Article 9(3),
it shall be prohibited in all Member States to use bones or bone-in cuts of bovine, ovine and caprine animals
for the production of mechanically separated meat.

6.

Measures concerning laceration of tissues

Notwithstanding the individual decisions referred to in Article 5(2), and by way of derogation from Article 8(3),
in all Member States, until all Member States are classified as countries with negligible BSE risk, laceration of
central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity after
stunning shall be prohibited in bovine, ovine or caprine animals whose meat is intended for human or animal
consumption.

7.

Harvesting of tongues from bovine animals

Tongues of bovine animals of all ages intended for human or animal consumption shall be harvested at the
slaughterhouse by a transverse cut rostral to the lingual process of the basihyoid bone.

8.

Harvesting of bovine head meat

8.1. Head meat of bovine animals above 12 months of age shall be harvested at slaughterhouses, in accordance with
a control system, recognised by the competent authority, to ensure the prevention of possible contamination of
include at least the following provisions:
head meat with central nervous system tissue. The system shall

(a) harvesting shall take place in a dedicated area, physically separated from the other parts of the slaughterline;

(b) where the heads are removed from the conveyor or hooks before harvesting the head meat, the frontal shot
hole and foramen magnum shall be sealed with an impermeable and durable stopper. Where the brainstem
is sampled for laboratory testing for BSE, the foramen magnum shall be sealed immediately after that
sampling;

(c) head meat shall not be harvested from heads where the eyes are damaged or lost immediately prior to, or
after slaughter, or which are otherwise damaged in a way which might result in contamination of the head
with central nervous tissue;

(d) head meat shall not be harvested from heads which have not been properly sealed in accordance with the

second indent;

(e) without prejudice to general rules on hygiene, specific working instructions shall be in place to prevent
contamination of the head meat during the harvesting, in particular in the case when the seal referred to in
the second indent is lost or the eyes damaged during the activity:

(f) a sampling plan using an appropriate laboratory test to detect central nervous system tissue shall be in

place to verify that the measures to reduce contamination are properly implemented.

8.2. By way of derogation from the requirements of point 8.1, Member States may decide to apply at the
slaughterhouse an alternative control system for the harvesting of bovine head meat, leading to an equivalent
reduction in the level of contamination of head meat with central nervous system tissue. A sampling plan using
an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the
measures to reduce contamination are properly implemented. Member States using this derogation shall
inform the Commission and the other Member States in the framework of the Standing Committee of the
Food Chain and Animal Health of their control system and the results of the sampling.

8.3.

If the harvesting is performed without removing the bovine head from the conveyor or hooks, points 8.1 and
8.2 shall not apply.

9.

Harvesting of bovine head meat in authorised cutting plants

By way of derogation from point 8, Member States may decide to allow the harvesting of head meat from
bovine in cutting plants specifically authorised for this purpose and provided that the following conditions are
complied with:

(a)

the heads intended for transport to the cutting plant shall be suspended on a rack during the storing period
and the transport from the slaughterhouse to the cutting plant;

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(b) the frontal shot hole and the foramen magnum shall be properly sealed with an impermeable and durable
stopper before being moved from the conveyor or hooks to the racks. Where the brainstem is sampled for
laboratory testing for BSE, the foramen magnum shall be sealed immediately after that sampling;

(c)

the heads which have not been properly sealed in accordance with point (b), where the eyes are damaged or
lost immediately prior to or after slaughter or which were otherwise damaged in a way which might result
in contamination of the head meat with central nervous tissue shall be excluded from transport to the
specifically authorised cutting plants;

(d) a sampling plan for the slaughterhouse using an appropriate laboratory test to detect central nervous
system tissue shall be in place to verify the proper implementation of the measures to reduce contam-
ination;

(e)

the harvesting of head meat shall be carried out in accordance with a control system, recognized by the
competent authority, to ensure the prevention of possible contamination of head meat. The system shall
include at least:

(i) all heads shall be visually checked for signs of contamination or damage and proper sealing before the

harvesting of the head meat begins;

(ii) head meat shall not be harvested from heads which have not been properly sealed, where the eyes are
damaged or which were otherwise damaged in a way which might result in contamination of the head
meat with central nervous tissue. Head meat shall also not be harvested from any head where
contamination from such heads is suspected;

(iii) without prejudice to general rules on hygiene, specific working instructions shall be in place to prevent
contamination of the head meat during transport and harvesting, in particular where the seal is lost or
the eyes damaged during the activity;

(f) a sampling plan for the cutting plant using an appropriate laboratory test to detect central nervous system
tissue shall be in place to verify that the measures to reduce contamination are properly implemented.

10. Rules on trade and export

10.1. Member States may allow dispatch of heads or of un-split carcasses containing specified risk material to
another Member State only after that Member State has agreed to receive the material and has approved
the conditions of dispatch and transport.

10.2. By way of derogation from point 10.1, carcasses, half carcasses or half carcasses cut into no more than three
wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including
dorsal root ganglia, may be dispatched from one Member State to another without the latter's prior agreement.

10.3. Exports outside the Community of heads and of fresh meat of bovine, ovine or caprine animals containing

specified risk materials shall be prohibited.

11. Controls

11.1. Member States shall carry out frequent official controls to verify the correct application of this Annex and shall
ensure that measures are taken to avoid any contamination, particularly in slaughterhouses, cutting plants or
other places where specified risk material is removed, such as butcher shops or establishments referred in point
4.1 (c).

11.2. Member States shall in particular set up a system to ensure and check that specified risk material is handled and

disposed of in accordance with Regulation (EC) No 999/2001 and Regulation (EC) No 1774/2002.

11.3. A control system shall be put in place for the removal of the vertebral column as specified in point 1(a). The

system shall include at least the following measures:

(a) when removal of the vertebral column is not required, carcasses or wholesale cuts of carcasses of bovine
animals containing vertebral column shall be identified by a clearly visible blue stripe on the label referred
to in Regulation (EC) No 1760/2000;

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(b) specific information on the number of bovine carcasses or wholesale cuts of carcasses, from which removal
of the vertebral column is required as well as the number where removal of the vertebral column is not
required, shall be added on the commercial document relating to consignments of meat. When applicable,
the specific information shall be added to the document referred to in Article 2(1) of Commission
Regulation (EC) No 136/2004 (*) in the case of imports;

(c) butcher shops shall keep, for at least one year, the commercial documents referred to in (b).

___________
(*) OJ L 21, 28.1.2004, p. 11.’

(3) Annex VI is replaced by the following:

‘ANNEX VI

PRODUCTS OF ANIMAL ORIGIN DERIVED FROM OR CONTAINING RUMINANT MATERIAL, AS
REFERRED TO IN ARTICLE 9(1)’

(4) Annex VIII is amended as follows:

(a) Chapter A is amended as follows:

(i) The title of Part I is replaced by the following:

‘I. Conditions which apply to ovine and caprine animals and semen and embryos thereof’.

(ii) Part II is replaced by the following:

‘II. Conditions which apply to bovine animals

The United Kingdom shall ensure that bovine animals born or reared on its territory before 1 August
1996 are not dispatched from its territory to other Member States or third countries.’

(b) Chapter C is replaced by the following:

Conditions for intra-Community trade in certain products of animal origin

‘CHAPTER C

SECTION A

Products

The following products of animal origin are exempt from the prohibition referred to in Article 16(3), provided
that they are derived from bovine, ovine and caprine animals that satisfy the requirements of Section B:

— fresh meat,

— minced meat,

— meat preparations,

— meat products.

SECTION B

Requirements

The products referred to in Section A must satisfy the following requirements:

(a)

the animals from which the products of bovine, ovine and caprine animal origin were derived have not been
fed meat-and-bone meal or greaves derived from ruminants and passed ante-mortem and post-mortem
inspections;

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(b) the animals from which the products of bovine, ovine and caprine animal origin were derived have not been
slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or
slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped
instrument introduced into the cranial cavity;

(c)

the products of bovine, ovine and caprine animal origin are not derived from:

(i) specified risk material as defined in Annex V;

(ii) nervous and lymphatic tissues exposed during the deboning process; and

(iii) mechanically separated meat obtained from bones of bovine, ovine or caprine animals.’

(5) Annex IX is amended as follows:

(a) Chapter A is deleted;

(b) Chapters B, C and D are replaced by the following:

‘CHAPTER B

Imports of bovine animals

SECTION A

Imports from a country or a region with a negligible BSE risk

Imports of bovine animals from a country or a region with a negligible BSE risk shall be subject to the
presentation of an animal health certificate attesting that:

(a)

the animals were born and continuously reared in a country or region classified in accordance with Article
5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE risk;

(b) the animals are identified by a permanent identification system enabling them to be traced back to the dam
and herd of origin, and are not exposed bovine animals as described in Chapter C, part I, point (4) (b) (iv) of
Annex II; and

(c)

if there have been BSE indigenous cases in the country concerned, the animals were born after the date from
which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had
been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the
feed ban.

SECTION B

Imports from a country or a region with a controlled BSE risk

Imports of bovine animals from a country or a region with a controlled BSE risk shall be subject to the
presentation of an animal health certificate attesting that:

(a)

the country or region is classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a
country or region posing a controlled BSE risk;

(b) the animals are identified by a permanent identification system enabling them to be traced back to the dam
and herd of origin, and are not exposed bovine animals as described in Chapter C, Part II, point (4)(b)(iv) of
Annex II;

(c)

the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone
meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last
BSE indigenous case if born after the date of the feed ban.

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SECTION C

Imports from a country or a region with undetermined BSE risk

Imports of bovine animals from a country or a region with an undetermined BSE risk shall be subject to the
presentation of an animal health certificate attesting that:

(a)

the country or region has not been categorized in accordance with Article 5(2) of Regulation (EC)
No 999/2001 or has been categorized as a country or region with undetermined BSE risk;

(b) the animals are identified by a permanent identification system enabling them to be traced back to the dam
and herd of origin, and are not exposed bovine animals as described in Chapter C, Part II, point (4)(b)(iv) of
Annex II;

(c)

the animals were born at least two years after the date from which the ban on the feeding of ruminants with
meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of
birth of the last BSE indigenous case if born after the date of the feed ban.

Imports of products of animal origin from bovine, ovine or caprine animals

CHAPTER C

SECTION A

Products

The following products of bovine, ovine and caprine animal origin, as defined by Regulation (EC) No 853/2004
of the European Parliament and of the Council (*) listed below shall be subject to the conditions laid down in
Sections B, C and D depending on the BSE risk category of the country of origin:

— fresh meat,

— minced meat and meat preparations,

— meat products,

— rendered animal fats,

— greaves, and

— gelatine.

SECTION B

Imports from a country or a region with a negligible BSE risk

Imports of products of bovine, ovine and caprine animal origin referred to in Section A from a country or a
region with a negligible BSE risk shall be subject to the presentation of an animal health certificate attesting that:

(a)

the country or region is classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a
country or region posing a negligible BSE risk;

(b) the animals from which the products of bovine, ovine and caprine animal origin were derived were born,
continuously reared and slaughtered in the country with negligible BSE risk and passed ante-mortem and
post-mortem inspections;

(c)

if in the country or region there have been BSE indigenous cases:

(i)

the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone
meal and greaves derived from ruminants had been enforced; or

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(ii) the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified
risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat
obtained from bones of bovine, ovine or caprine animals.

SECTION C

Imports from a country or a region with a controlled BSE risk

1. Imports of products of bovine, ovine and caprine animal origin referred to in section A from a country or a
region with a controlled BSE risk shall be subject to the presentation of an animal health certificate attesting
that:

(a) the country or region is classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a

country or region posing a controlled BSE risk;

(b) the animals from which the products of bovine, ovine and caprine animal origin were derived passed ante-

mortem and post-mortem inspections;

(c) animals from which the products of bovine, ovine and caprine animal origin destined for export were
derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed
by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an
elongated rod-shaped instrument introduced into the cranial cavity;

(d) the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified
risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat
obtained from bones of bovine, ovine or caprine animals.

2. By way of derogation from point 1(d) carcasses, half carcasses or half carcasses cut into no more than three
wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including
dorsal root ganglia, may be imported.

3. When removal of the vertebral column is not required, carcasses or wholesale cuts of carcasses of bovine
animals containing vertebral column, shall be identified by a blue stripe on the label referred to in Regulation
(EC) No 1760/2000.

4. The number of bovine carcasses or wholesale cuts of carcasses, from which removal of the vertebral column is
required as well as he number where removal of the vertebral column is not required shall be added to the
document referred to in Article 2(1) of Regulation (EC) No 136/2004 in case of imports.

SECTION D

Imports from a country or a region with an undetermined BSE risk

1. Imports of products of bovine, ovine and caprine animal origin referred to in Section A from a country or a
region with an undetermined BSE risk, shall be subject to the presentation of an animal health certificate
attesting that:

(a) the animals from which the products of bovine, ovine and caprine animal origin were derived have not
been fed meat-and-bone meal or greaves derived from ruminants and passed ante-mortem and post-
mortem inspections;

(b) the animals from which the products of bovine, ovine and caprine animal origin were derived have not
been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same
method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-
shaped instrument introduced into the cranial cavity;

(c) the products of bovine, ovine and caprine animal origin are not derived from:

(i) specified risk material as defined in Annex V;

(ii) nervous and lymphatic tissues exposed during the deboning process;

(iii) mechanically separated meat obtained from bones of bovine, ovine or caprine animals.

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2. By way of derogation from point 1(c), carcasses, half carcasses or half carcasses cut into no more than three
wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including
dorsal root ganglia, may be imported.

3. When removal of the vertebral column is not required, carcasses or wholesale cuts of carcasses of bovine
animals containing vertebral column, shall be identified by a clearly visible blue stripe on the label referred to
in Regulation (EC) No 1760/2000.

4. Specific information on the number of bovine carcasses or wholesale cuts of carcasses, from which removal of
the vertebral column is required and from which removal of the vertebral column is not required shall be
added to the document referred to in Article 2(1) of Regulation (EC) No 136/2004 in case of imports.

Imports of animal by-products and processed products derived therefrom from bovine, ovine and
caprine animal origin

CHAPTER D

SECTION A

Animal by-products

This Chapter shall apply to the following animal by-products and processed products derived therefrom from
bovine, ovine and caprine animal origin as referred to in Regulation (EC) No 1774/2002:

— rendered fats,

— pet food,

— blood products,

— the processed animal protein,

— bones and bone products,

— category 3 material, and

— gelatine.

Imports of the animal by-products processed products derived therefrom from bovine, ovine and caprine animal
origin referred to in Section A. shall be subject to the presentation of an animal health certificate attesting that:

SECTION B

(a)

the animal by-product does not contain and is not derived from specified risk material as defined in Annex V
or mechanically separated meat obtained from bones of bovine, ovine or caprine animals;

(b) the animals from which this animal by-product is derived, have not been slaughtered after stunning by means
of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration of central
nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity,

or

(c)

the animal by-product does not contain and is not derived from bovine, ovine and caprine materials other
than those derived from animals born, continuously reared and slaughtered in a country or region classified in
accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE
risk.

___________
(*) OJ L 139, 30.4.2004, p. 55, as corrected by OJ L 226, 25.6.2004, p. 22.’

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(c) Chapter F is replaced by the following:

‘CHAPTER F

Imports of products of animal origin from farmed and wild cervid animals

1. When fresh meat, minced meat, meat preparations and meat products as defined by Regulation (EC)
No 853/2004, derived from farmed cervid animals, are imported into the Community from Canada or the
United States of America, the health certificates shall be accompanied by a declaration signed by the competent
authority of the country of production, worded as follows:

“This product contains or is derived exclusively from meat, excluding offal and spinal cord, of farmed cervid
animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or
other diagnostic method recognized by the competent authority with negative results and is not derived from
animals coming from a herd where chronic wasting disease has been confirmed or is officially suspected.”

2. When fresh meat, minced meat, meat preparations and meat products as defined by Regulation (EC)
No 853/2004, derived from wild cervid animals, are imported into the Community from Canada or the
United States of America, the health certificates shall be accompanied by a declaration signed by the competent
authority of the country of production, worded as follows:

“This product contains or is derived exclusively from meat, excluding offal and spinal cord, of wild cervid
animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or
other diagnostic method recognized by the competent authority with negative results and is not derived from
animals coming from a region where chronic wasting disease has been confirmed in the last three years or is
officially suspected.” ’

(d) Chapter G is deleted.

(6) Annex XI is deleted.