PREVENTION, CONTROL AND ERADICATION OF CERTAIN TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES REGULATIONS *

SUBSIDIARY LEGISLATION 437.42

PREVENTION, CONTROL AND ERADICATION OF

CERTAIN TRANSMISSIBLE SPONGIFORM

ENCEPHALOPATHIES REGULATIONS *

6th February, 2004

LEGAL NOTICE 58 of 2004.

CHAPTER I

GENERAL PROVISIONS

(1) The title of these regulations is the Prevention, Control

and Eradication of Certain Transmissible Spongiform

Encephalopathies Regulations.

(2) The scope of these regulations is the implementation of

European Parliament and European Union Council Regulation (EC)

No. 999/2001 laying down rules for the prevention, control and

eradication of certain transmissible spongiform encephalopathies.

These regulations provide rules for the prevention, control and

eradication of transmissible spongiform encephalopathies (TSEs)

in animals. It shall apply to the production and placing on the

market of live animals and products of animal origin and in certain

specific cases to exports thereof.

(3)

These regulations shall not apply to -

(a) cosmetic or medicinal products or medical devices, or

to their starting materials or intermediate products;

(b) products which are not intended for use in human

food, animal feed or fertilisers, or to their starting

materials or intermediate products;

(c) products of animal origin intended for exhibition,

teaching, scientific research, special studies or

analysis, provided those products are not eventually

consumed or used by humans or by animals other than

those kept for the research projects concerned;

(d) live animals used in or intended for research.

SPECIFIC DEFINITIONS

1. For the purpose of these regulations, the following definitions set out in

European Union Parliament and Council Regulation (EC) No 1774/2002 (OJ L 273,

10.10.2002), European Union Parliament and Council Regulation (EC) No 178/2002

(OJ L 31, 1.2.2002) and European Union Council Directive 79/373/EEC (OJ L 86,

6.4.1979) shall apply

(a) Regulation (EC) No 1774/2002 -

(i)

"farmed animal" in article 2(1)(f);

(ii)

"petfood" in point 41 of Annex I;

(iii)

"processed animal protein" in point 42 of Annex I;

(iv)

"gelatine" in point 26 of Annex I;

(v)

"blood products" in point 4 of Annex I;

(vi)

"bloodmeal" in point 6 of Annex I; and

(vii)

"fishmeal" in point 24 of Annex I;

(b) the definition of "feedingstuff" in article 3(4) of European Union

Parliament and Council Regulation (EC) No 178/2002;

(c) the definition of "complete feedingstuff" in article 2(d) of European

Union Council Directive 79/373/EEC.

2. For the purpose of these regulations, the following definitions shall also

apply

(a) "indigenous case of BSE" means a case of bovine spongiform

encephalopathy which has not been clearly demonstrated to be due to

infection prior to importation as a live animal;

(b) "discrete adipose tissue" means internal and external body fat removed

during the slaughter and cutting process, in particular fresh fat from the

heart, caul and kidney of bovine animals, and fat from cutting rooms;

(c) "cohort" means a group of bovine animals which were -

(i)

born in the same herd as the affected bovine animal, and within

twelve months preceding or following the birth of the affected

animal; or

(ii) reared together with the affected bovine animal at any time during

the first year of their life and which may have consumed the same

feed as that which the affected a bovine animal consumed during

the first year of its life.

Separation of live animals and of products of animal origin

in order to avoid cross-contamination or substitution between the

live animals or of the products of animal origin referred to in

regulation 1(2) and the products of animal origin referred to in

regulation 1(3)(a), (b) and (c), or the live animals referred to in

regulation 1(3)(d), they shall be kept separate at all times unless

such live animals or products of animal origin are produced under

at least the same conditions of health protection in respect of TSEs.

Rules for the implementation of this regulation shall be adopted in

accordance with the procedure referred to in regulation 24(2) and

also the rules found under article 4 of the Veterinary Services Act

shall apply.

*These regulations have been repealed by Legal Notice 38 of 2025.

PREVENTION, CONTROL AND ERADICATION OF CERTAIN

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

DETERMINATION OF BSE STATUS

CHAPTER A

The BSE status of a Member State or a third country or of one of their regions,

hereinafter referred to as "country or region", shall be determined on the basis of the

following criteria

(a) the outcome of a risk analysis identifying all the potential factors for the

appearance of BSE referred to in Chapter B and their development over

time;

(b) an education programme for veterinarians, breeders and those who

transport, trade in and slaughter bovine animals, which seeks to

encourage them to report all cases of neurological manifestations in

adult bovine animals;

(c) the compulsory reporting and examination of all bovine animals

showing clinical signs of BSE;

(d) a system of continuous surveillance and monitoring of BSE with

particular reference to the risks described in Chapter B, taking account

of the guidelines in the table of Chapter A of Schedule III or in

accordance with the appropriate international standards; reports on the

number of examinations carried out and the results thereof must be kept

for at least seven years;

(e) the examination in an approved laboratory of samples of encephala or

other tissues collected under the surveillance system mentioned in point

(d).

CHAPTER B

The risk analysis referred to in Chapter A (a) shall be based on the following

the consumption by bovine animals of meat and bonemeal or greaves

derived from ruminants;

the importation of meat and bonemeal or greaves potentially

contaminated by a TSE or animal feed containing meat and bonemeal or

greaves;

the importation of animals or ova, embryos potentially infected by a

TSE;

the epidemiological status of the country or region in regard to animal

TSEs;

the extent of knowledge about the structure of the bovine, ovine and

caprine population in the country or region;

the source of animal waste, the parameters of the processes for treating

such waste and the methods of producing animal feed.

CHAPTER C

Definition of categories

The BSE status of Member States or third countries or one of the regions thereof

shall be determined by classification into the following categories -

A. CATEGORY 1 -

''Country or region free of BSE'' is a country or region where a risk analysis based

on the information laid down in Chapter B has been conducted which demonstrated

that appropriate measures have been taken for the relevant period of time, to manage

any risk identified and -

1. EITHER no BSE case has been recorded and -

(i)

the criteria in Chapter A (b) to (e) have been complied with for at

least seven years, or

(ii) the criteria in Chapter A (c) have been complied with for at least

seven years and it has been demonstrated that for at least eight

years no meat and bonemeal or greaves derived from ruminants or

mammals has been fed to ruminants;

2. OR where all cases of BSE have been clearly demonstrated to originate

directly from the importation of live bovine animals or bovine embryos,

ova, and all the affected bovine animals as well as, if these are females,

their last progeny born within two years prior to, or after, the first

clinical signs of onset of the disease, if alive in the country or region,

have been killed and completely destroyed and, either -

(i)

the criteria in Chapter A (b) to (e) have been complied with for at

least seven years, or,

(ii) the criteria in Chapter A (c) have been complied with for at least

seven years and it has been demonstrated that for at least eight

years no meat and bonemeal or greaves have been fed to

ruminants;

3. OR where the last indigenous case of BSE was reported more than seven

years ago, the criteria in Chapter A (b) to (e) have been complied with

for at least seven years and the feeding of ruminants with meat and

bonemeal and greaves derived from ruminants has been banned and the

ban has been effectively enforced for at least eight years.

CATEGORY 2 -

BSE provisionally free country or region where no indigenous case has been

reported country or region where a risk analysis as described in Chapter B has been

conducted which demonstrates that appropriate measures have been taken for the

relevant period of time to manage any risk identified, and -

1. EITHER where there has been no case of BSE and -

(i)

the criteria in Chapter A (b) to (e) are complied with, but have not

been complied with for seven years, or

(ii) it has been demonstrated that for at least eight years no meat and

bonemeal or greaves has been fed to ruminants, but the criteria in

Chapter A (c) have not been complied with for seven years;

2. OR where all cases of BSE have been clearly demonstrated to originate

directly from the importation of live bovine animals or bovine embryos,

ova, and all the affected bovine animals as well as, if these are females,

their last progeny born within two years prior to, or after, the first

clinical signs of onset of the disease, if alive in the country or region,

have been killed and completely destroyed, and either -

(i)

the criteria in Chapter A (b) to (e) are complied with, but have not

been complied with for seven years, or,

(ii) it has been demonstrated that for at least eight years no meat and

bonemeal or greaves has been fed to ruminants, but the criteria in

Chapter A (c) have not been complied with for seven years.

CATEGORY 3 -

BSE provisionally free country or region where at least one indigenous case has

been reported. Any country or region where a risk analysis based on the information

referred to in Chapter B has been conducted which demonstrates that appropriate

measures have been taken for the relevant period of time to manage any risk

identified and -

1. EITHER the last indigenous case of BSE was reported more than seven

years ago, the criteria in Chapter A (b) to (e) are complied with and the

ban on feeding ruminants with meat and bonemeal and greaves derived

from ruminants is effectively enforced, but -

(i)

the criteria in Chapter A (b) to (e) have not been complied with

for seven years, or,

(ii) the ban on feeding ruminants with meat and bonemeal and

greaves derived from ruminants has not been effectively enforced

for eight years;

2. OR where the last indigenous case has been reported less than seven

years ago, the BSE incidence rate, calculated on the basis of indigenous

cases, has been less than one case per million during each of the last

four consecutive twelvemonth periods within the bovine animal

population over 24 months of age in the country or region or when in a

country or a region the bovine animal population over 24 months of age

is less than 1 million animals one case per real number of this

population (calculated on the basis of Eurostat statistics), and where -

(i)

the ban on feeding ruminants with meat and bonemeal and

greaves derived from ruminants has been effectively enforced for

at least eight years;

(ii) the criteria in Chapter A (b) to (e) have been complied with for at

least seven years;

(iii) the affected bovine animals as well as -

- if these are females, their last progeny born within two years

prior to, or after, clinical onset of the disease;

- all bovine animals from the cohort, are killed and completely

destroyed if they are still alive in the country or region

concerned.

For this classification account may be taken, by way of derogation from point (iii),

of the existence of other measures offering an equivalent level of protection in

relation to the killing of animals at risk.

CATEGORY 4 -

Country or region with low incidence of BSE -

Any country or region where -

1. the criteria listed in Chapter A are complied with, and the BSE

incidence rate, calculated over the past 12 months, has been greater than

or equal to one indigenous case per million and less than or equal to one

hundred cases per million within the bovine animal population over 24

months of age in the country or region; or

2. the criteria listed in Chapter A are complied with and the BSE incidence

rate, calculated as specified in point 1 has been less than one indigenous

case per million for less than four consecutive 12 month periods and the

affected cattle as well as -

-

if these are females, their last progeny born within two years prior

to, or after the first clinical signs of onset of the disease,

-

all bovine animals from the cohort,

-

if alive in the country or region, are killed and completely

destroyed.

For this classification account may be taken, by way of derogation from this point,

of the existence of other measures offering an equivalent level of protection in

relation to the killing of animals at risk.

Countries or regions where the BSE incidence rate, calculated over the past 12

months, has been less than one indigenous case per million within the cattle

population over 24 months of age in the country or region, but where a risk analysis

as described in Chapter A has been conducted which demonstrates that at least one

of the criteria enabling the country or region to be classified in category 2 or 3 is not

complied with, must be regarded as countries or regions belonging to category 4.

CATEGORY 5 -

Country or region with high incidence of BSE -

Any country or region where -

1. the criteria listed in Chapter A are complied with, and the BSE

incidence rate, calculated over the past 12 months, has been greater than

one hundred cases per million within the bovine animal population over

24 months of age in the country or region; or

2. the BSE incidence rate, calculated over the past 12 months, has been

greater than or equal to one case per million and less than or equal to

one hundred cases per million within the bovine animal population over

24 months of age in the country or region, and at least one of the criteria

listed in Chapter A is not complied with.

(1) For the purposes of these regulations the following

definitions shall apply -

(a) ''animal suspected of being infected by a TSE'' means

live, slaughtered or dead animals, which show or have

shown neurological or behavioural disorders or a

progressive deterioration of the general condition

linked to impairment of the central nervous system and

for which the information gathered on the basis of a

clinical examination, response to treatment, a post-

mortem examination or an ante or post-mortem

laboratory analysis do not allow an alternative

diagnosis to be established. Bovine spongiform

encephalopathies (BSE) shall be suspected in bovine

animals which have produced a positive result from a

rapid test specifically for BSE;

(b) ''alternative test'' means the tests referred to in

regulation 8(2) which are used as an alternative to the

withdrawal of specified risk material;

(c) ''category'' means one of the classification categories

referred to in Chapter C of Schedule II;

(d) ''competent authority'' means the central authority of a

Member State, competent to ensure compliance with

the requirements of these regulations or any authority

to which that central authority has delegated that

competence, in particular for the control of

feedingstuffs; it shall also include, where appropriate,

the corresponding authority of a third country; for the

territory of Malta the Veterinary Services are the

competent authority;

(e) ''fertilisers'' means any substance containing products

of animal origin utilised on land to enhance growth of

vegetation; it may include digestion residues from

biogas production or composting;

(f)

''holding'' means any place in which animals covered

by these regulations are held, kept, bred, handled or

shown to the public;

(g) ''placing on the market'' means any operation the

purpose of which is to sell live animals or products of

animal origin covered by these regulations to a third

party in the European Community, or any other form

of supply against payment or free of charge to such a

third party or storage with a view to supply to such a

third party;

(h) ''products of animal origin'' means any product derived

from or containing a product derived from any animal

covered by the provisions of European Union Council

Directive 89/662/EEC concerning veterinary checks in

intra-Community trade with a view to the completion

of the internal market or European Union Council

Directive 90/425/EEC concerning veterinary and

zootechnical checks applicable in intra-Community

trade in certain live animals and products with a view

to the completion of the internal market;

(i)

''rapid tests'' means the analysis methods referred to in

Schedule X, Chapter C, point 4, and for which the

results are known within twenty-hours hours;

(j)

''sampling'' means the taking of samples, ensuring a

statistically correct representation, from animals or

their environment, or from products of animal origin,

for the purpose of establishing a disease diagnosis,

familial relationships, for health surveillance, or for

the monitoring of the absence of microbiological

agents or of certain materials in products of animal

origin;

(k) ''specified risk material'' means the tissues specified in

Schedule V; unless otherwise indicated, it does not

include products containing or derived from those

tissues;

(l)

''starting materials'' means raw materials or any other

product of animal origin out of which, or with the help

of which, the products referred to in regulation 1(3)(a)

and (b) are produced;

(m) ''trading partner'' in the meaning of article 2 of the

Veterinary Services Act, shall mean -

(i) Member States of the European Community;

(ii) Third Countries to the European Community;

where relevant;

(n) ''TSEs''

means

all

transmissible

spongiform

encephalopathies with

the exception of those

occurring in humans.

(2) The specific definitions set out in Schedule I shall also

apply.

(3) Where the terms in these regulations are not defined in sub-

regulation (1) or Schedule I, the relevant definitions given in

European Union Parliament and Council Regulation (EC) No 1760/

2000 and those given in or pursuant to European Union Council

Directives 64/432/EEC, 89/662/EEC, 90/425/EEC and 91/68/EEC

shall apply insofar as reference is made to them in this text.

MONITORING SYSTEM

CHAPTER A

MONITORING IN BOVINE ANIMALS

1. General

Monitoring in bovine animals shall be carried out in accordance with the

laboratory methods laid down in Schedule X, Chapter C, point 3(1)(b).

2. Monitoring in animals slaughtered for human consumption

2.1. All bovine animals over 24 months of age -

subject to "special emergency slaughtering" as defined in article 2(n) of

European Union Council Directive 64/433/EEC, or

slaughtered in accordance with Annex I, Chapter VI, point 28(c), to

European Union Council Directive 64/433/EEC, except animals without

clinical signs of disease slaughtered in the context of a disease

eradication campaign,

shall be tested for BSE.

2.2. All bovine animals over 30 months of age -

subject to normal slaughter for human consumption, or

slaughtered in the context of a disease eradication campaign in

accordance with Annex I, Chapter VI, point 28(c), to Directive 64/433/

EEC, but showing no clinical signs of disease,

shall be tested for BSE.

3. Monitoring in animals not slaughtered for human consumption

3.1. All bovine animals over 24 months of age which have died or been killed but

which were not -

-

killed for destruction pursuant to European Union Commission

Regulation (EC) No 716/96,

-

killed in the framework of an epidemic, such as foot-and-mouth disease,

-

slaughtered for human consumption,

shall be tested for BSE.

3.2. Member States may decide to derogate from the provisions of point 3.1 in

remote areas with a low animal density, where no collection of dead animals is

organised. Member States making use of this derogation shall inform the European

Commission thereof, and submit a list of the derogated areas. The derogation shall

not cover more than 10% of the bovine population in the Member State.

4. Monitoring in animals purchased for destruction pursuant to European

Union Regulation (EC) No 716/96

4.1. All animals subject to casualty slaughter or found sick at ante mortem

inspection shall be tested for BSE.

4.2. All animals over 42 months of age born after 1 August 1996 shall be tested

for BSE.

4.3. A random sample comprising at least 10000 animals annually of animals not

covered by points 4.1 or 4.2 shall be tested for BSE.

5. Monitoring in other animals

In addition to the testing referred to in points 2 to 4, Member States may on a

voluntary basis decide to test other bovine animals on their territory, in particular

where those animals originate from countries with indigenous BSE, have consumed

potentially contaminated feedingstuffs or were born or derived from BSE infected

dams.

6. Measures following testing

6.1. Where an animal slaughtered for human consumption has been selected for

testing for BSE, the health marking provided for in Chapter XI of Annex I to

European Union Council Directive 64/433/EEC shall not be carried out on the

carcass of that animal until a negative result to the rapid test has been obtained.

6.2. Member States may derogate from the provisions of point 6.1 where an

official system is in place in the slaughterhouse ensuring that no parts of examined

animals bearing the health mark leave the slaughterhouse until a negative result to

the rapid test has been obtained.

6.3. All parts of the body of an animal tested for BSE including the hide shall be

retained under official control until a negative result to the rapid test has been

obtained, unless they are destroyed in accordance with Schedule V, point 3 or 4.

6.4. All parts of the body of an animal found positive to the rapid test including

the hide shall be destroyed in accordance with Schedule V, point 3 or 4, apart from

material to be retained in conjunction with the records provided for in Chapter B,

section III.

6.5. Where an animal slaughtered for human consumption is found positive to

the rapid test, at least the carcass immediately preceding the test-positive carcass and

two carcasses immediately following the test-positive carcass on the same slaughter

line shall be destroyed in accordance with point 6.4, in addition to the test-positive

carcass.

6.6. Member States may derogate from the provisions of point 6.5 where a

system is in place in the slaughterhouse preventing contamination between carcass.

II.

MONITORING IN OVINE AND CAPRINE ANIMALS

1. General

Monitoring in ovine and caprine animals shall be carried out in accordance with

the laboratory methods laid down in Schedule X, Chapter C, point 3.2(b).

2. Monitoring in animals slaughtered for human consumption

Animals over 18 months of age or which have more than two permanent incisors

erupted through the gum and which are slaughtered for human consumption shall be

tested in accordance with the sample size indicated in the table. The sampling shall

be representative for each region and season. The sample selection shall be designed

with a view to avoid the over-representation of any group as regards the origin,

species, age, breed, production type or any other characteristic. The age of the

animals shall be the estimated based on dentition, obvious signs of maturity or other

reliable information. Multiple sampling in the same flock shall be avoided, where

possible.

Member State

Minimum annual sample size (1)

Slaughtered animals

Belgium

3, 750

Denmark

3, 000

Germany

60, 000

Greece

60, 000

Spain

60, 000

France

60, 000

Ireland

60, 000

Italy

60, 000

Luxembourg

Netherlands

39, 000

Austria

8, 200

Portugal

22, 500

Finland

1, 900

Sweden

5, 250

United Kingdom

60, 000

(1) The sample size has been calculated to detect a prevalence of 0,005 % with a

95 % confidence in slaughtered animals in Member States which slaughter a large

number of adult sheep. In those Member States which slaughter a smaller number of

adult sheep, the sample size is calculated as 25% of the estimated or recorded

number of cull ewes slaughtered in 2000.

A Member State may test a number of animals less than that indicated in the table

if the most recent official slaughter statistics indicate that this number is equivalent

to 25 % of cull ewes slaughtered annually in the Member State.

3. Monitoring in animals not slaughtered for human consumption

Animals over 18 months of age or which have more than two permanent incisors

erupted through the gum which have died or been killed, but which were not -

-

killed in the framework of a disease eradication campaign,

-

slaughtered for human consumption,

shall be tested in accordance with the sample size indicated in the table. The

sampling shall be representative for each region and season. The sample selection

shall be designed with a view to avoid the over-representation of any group as

regards the origin, species, age, breed, production type or any other characteristic.

The age of the animal shall be estimated based on dentition, obvious signs of

maturity or other reliable information. Multiple sampling in the same flock shall be

avoided, where possible.

Member States may decide to exclude remote areas with a low animal density,

where no collection of dead animals is organised, from the sampling. Member States

making use of this derogation shall inform the European Commission thereof, and

submit a list of the derogated areas. The derogation shall not cover more than 10% of

the ovine and caprine population in the Member State.

Member State

Minimum annual sample size (1)

Dead animals

Belgium

Denmark

Germany

6, 000

Greece

6, 000

Spain

6, 000

France

6, 000

Ireland

6, 000

Italy

6, 000

Luxembourg

Netherlands

5, 000

Austria

1, 100

Portugal

6, 000

Finland

Sweden

United Kingdom

6, 000

(1) The sample size has been calculated to detect a prevalence of 0,05 % with a

95% confidence in dead animals in Member States with a large sheep population. In

those Member States with a smaller sheep population, the sample size is calculated

as 50% of the estimated number of dead animals (estimated mortality 1%).

4. Monitoring in infected flocks

From 1 October 2003, animals over 12 months or which have a permanent incisor

erupted through the gum, which are killed in accordance with the provisions of

Schedule VII, point 2(b)(i) or (ii) or point 2(c), shall be tested based on the selection

of a simple random sample, in accordance with the sample size indicated in the

table.

Number of culled animals over 12 months in the herd or flock

Minimum sample size (1)

70 or less

500 or more

(1) The sample size is calculated to be 95% certain of including at least one

positive if the disease is present at a minimum prevalence of 2% in the test

population.

5. Monitoring in other animals

In addition to the monitoring programmes set out in points 2, 3 and 4, Member

States may on a voluntary basis carry out monitoring in other animals, in particular -

-

animals used for dairy production,

-

animals originating from countries with indigenous TSEs,

-

animals which have consumed potentially contaminated feedingstuffs,

-

animals born or derived from TSE infected dams,

-

animals from flocks infected with TSE.

6. Measures following testing of ovine and caprine animals

6.1. Where an animal slaughtered for human consumption has been selected for

testing for TSE, the health marking provided for in Chapter XI of Annex I to

European Union Council Directive 64/433/EEC shall not be carried out on the

carcass of that animal until a negative result to the rapid test has been obtained.

6.2. Member States may derogate from the provisions of point 6.1 where an

official system is in place in the slaughterhouse ensuring that no parts of examined

animals bearing the health mark leave the slaughterhouse until a negative result to

the rapid test has been obtained.

6.3. All parts of the body of a tested animal including the hide shall be retained

under official control until a negative result to the rapid test has been obtained,

unless they are destroyed in accordance with Schedule V, point 3 or 4.

6.4. All parts of the body of an animal found positive to the rapid test including

the hide shall be destroyed in accordance with Schedule V, point 3 or 4, apart from

material to be retained in conjunction with the records provided for in Chapter B,

Section III.

7. Genotyping

7.1. The prion protein genotype shall be determined for each positive TSE case

in sheep. TSE cases found in resistant genotypes (sheep of genotypes which encode

alanin on both alleles at codon 136, arginin on both alleles at codon 154 and arginin

on both alleles at codon 171) shall immediately be reported to the European

Commission. Where possible, such cases shall be submitted for strain-typing. Where

strain-typing of such cases is not possible, the herd of origin and all other herds

where the animal has been shall be subjected to enhanced monitoring with a view to

find other TSE cases for strain-typing.

7.2. In addition to the animals genotyped under the provisions of point 7.1, the

prion protein genotype of a random subsample of the ovine animals tested under the

provisions of Chapter A, Section II, point 2 shall be determined. This subsample

shall represent at least one per cent of the total sample for each Member State, and

shall not be less than 100 animals per Member State. By derogation, Member States

may choose to genotype an equivalent number of live animals of a similar age.

III.

MONITORING IN OTHER ANIMAL SPECIES

Member States may on a voluntary basis carry out monitoring for TSE in animal

species other than bovine, ovine and caprine animals.

CHAPTER B

I.

INFORMATION TO BE PRESENTED BY MEMBER STATES IN THEIR

REPORT

1. The number of suspected cases per animal species placed under movement

restrictions in accordance with regulation 12(1).

2. The number of suspected cases per animal species subject to laboratory

examination in accordance with regulation 12(2) and the outcome of the

examination.

3. The number of flocks where suspected cases in ovine and caprine animals

have been reported and investigated pursuant to regulation 12(1) and (2).

4. The estimated size of each subpopulation referred to in Chapter A, Section I,

points 3 and 4.

5. The number of bovine animals tested within each subpopulation referred to

in Chapter A, Section I, point 2 to 5, the method for sample selection and the

outcome of the tests.

6. The estimated size of those subpopulations referred to in Chapter A, Section

II, points 2 and 3 which have been selected for sampling.

7. The number of ovine and caprine animals and flocks tested within each sub-

population referred to in Chapter A, Section II, points 2 to 5, the method for sample

selection and the outcome of the tests.

8. Number, age distribution and geographical distribution of positive cases of

BSE and scrapie. The country of origin, if not the same as the reporting country, of

positive cases of BSE and scrapie. Number and geographical distribution of scrapie

positive flocks. The year and, where possible, month of birth should be given for

each BSE case.

9. Positive TSE cases confirmed in animals other than bovine, ovine and

caprine animals.

10. The genotype and where possible breed of each animal sampled within each

sub-population referred to in Chapter A, part II, points 7.1 and 7.2.

INFORMATION TO BE PRESENTED BY THE COMMISSION IN ITS

SUMMARY

The summary shall be presented in a tabled format covering at least the

information referred to in Part I for each Member State.

RECORDS

1. The competent authority shall keep, for seven years, records of -

the number and types of animals placed under movement restrictions as

referred to in regulation 12(1),

the number and outcome of clinical and epidemiological investigations

as referred to in regulation 12(1),

the number and outcome of laboratory examinations as referred to in

regulation 12(2),

the number, identity and origin of animals sampled in the framework of

the monitoring programmes as referred to in Chapter A and, where

possible, age, breed and anamnestic information,

the prion protein genotype of positive TSE cases in sheep.

2. The investigating laboratory shall keep, for seven years, all records of

testing, in particular laboratory workbooks and, where appropriate, paraffin blocks

and photographs of western blots.

(1) With regard to the implementation of safeguard

measures, the principles and provisions set out in article 9 of

European Union Council Directive 89/662/EEC, article 10 of

European Union Council Directive 90/425/EEC, article 18 of

European Union Council Directive 91/496/EEC and article 22 of

European Union Council Directive 97/78/EC shall apply.

(2) The safeguard measures shall be adopted in accordance

with the procedure referred to in regulation 24(2) and the rules

found under article 4 of the Veterinary Services Act shall apply.

These measures shall be notified at the same time to the European

Parliament, stating the reasons.

CHAPTER II

DETERMINATION OF BSE STATUS

ANIMAL FEEDING

Extension of the prohibition provided for in regulation 7(1)

1. The prohibition provided for in regulation 7(1) shall be extended to the

(a) to farmed animals, with the exception of the feeding of carnivorous fur

producing animals, of -

(a)

processed animal protein;

(b)

gelatine of ruminant origin;

(c)

blood products;

(d)

hydrolysed protein;

(e)

dicalcium phosphate and tricalcium phosphate of animal origin;

(f)

feedingstuffs containing the proteins listed in points (a) to (e);

(b) to ruminants of animal protein and feedingstuffs containing such

protein.

2. I. Derogations from the prohibitions provided for in regulation 7(1) and (2),

and specific conditions for the application of such derogations.

The prohibitions provided for in regulation 7(1) and (2) shall not apply to -

(a) the feeding to non-ruminants of the proteins referred to in (i), (ii) and

(iii), and of feedingstuffs derived from such proteins, provided that

those proteins have been processed where applicable in accordance with

article 19 of European Union Regulation (EC) No 1774/2002 -

(i) fishmeal, in accordance with the conditions laid down in point B;

(ii) hydrolysed proteins derived from non-ruminants and ruminant

hides and skins, in accordance with the conditions laid down in

point C;

(iii) dicalcium phosphate and tricalcium phosphate, in accordance

with the conditions laid down in point D;

(b) the feeding to ruminants of the proteins referred to in (i), (ii) and (iii),

and of products derived from such proteins, provided that the proteins

have been processed where applicable in accordance with the provisions

in article 19 of European Union Regulation (EC) No 1774/2002 -

(i) milk, milk-based products and colostrum;

(ii) eggs and egg products;

(iii) gelatine derived from non-ruminants;

(c) the feeding to fish of blood products and bloodmeal derived from non-

ruminants, provided that they have been processed where applicable in

accordance with article 19 of European Union Regulation (EC) No

1774/2002 and of feedingstuffs derived from such proteins, in

accordance with the conditions laid down in point E.

Conditions for the use of fishmeal and feedingstuffs containing fishmeal in

the feeding of non-ruminant farmed animals with the exception of carnivorous fur

producing animals.

(a) The fishmeal shall be produced in processing plants dedicated

exclusively to the production of fish derived products, which shall be

approved for this purpose by the competent authority in accordance

with article 17 of European Union Regulation (EC) No 1774/2002.

(b) Before release for free circulation in the European Community, each

consignment of imported fishmeal shall be analysed in accordance with

European Union Commission Directive 98/88/EC.

(c) Feedingstuffs containing fishmeal shall be produced in establishments

which do not produce feedingstuffs for ruminants and which are

authorised for this purpose by the competent authority.

However, by way of derogation from that condition -

(i)

a specific authorisation for the production of complete

feedingstuffs from feedingstuffs containing fishmeal is not

required for home compounders -

- registered by the competent authority,

- keeping only non-ruminants,

- producing complete feedingstuffs for use only in the same

holding, and

- provided that the feedingstuffs containing fishmeal used in

the production contain less than 50% crude protein;

(ii) the production of feedingstuffs for ruminants in establishments

which also produce feedingstuffs containing fishmeal for other

animal species may be authorised by the competent authority

subject to the following conditions -

- bulk and packaged feedingstuffs destined for ruminants are

manufactured in facilities physically separate from facilities

where feedingstuffs containing fishmeal are manufactured,

-

bulk feedingstuffs destined for ruminants are kept in facilities

physically separate from facilities where bulk fishmeal and

bulk feedingstuffs containing fishmeal are kept during

storage, transport and packaging,

-

records detailing the purchases and uses of fishmeal and the

sales of feedingstuffs containing fishmeal are kept available

to the competent authority for at least five years, and

-

routine tests are carried out on feedingstuffs destined to

ruminants to ensure that prohibited proteins including

fishmeal are not present.

(d) The label and accompanying document of feedingstuffs containing

fishmeal shall clearly indicate the words "contains fishmeal - cannot be

fed to ruminants".

(e) Bulk feedingstuffs containing fishmeal shall be transported by means of

vehicles which do not transport at the same time feedingstuffs for

ruminants. If the vehicle is subsequently used for the transport of

feedingstuffs intended for ruminants, it shall be thoroughly cleaned in

accordance with a procedure approved by the competent authority to

avoid cross-contamination.

(f)

The use and storage of feedingstuffs containing fishmeal shall be

prohibited in farms where ruminants are kept.

By way of derogation from that condition, the competent authority may

permit the use and storage of feedingstuffs containing fishmeal in farms

where ruminants are kept, if they are satisfied that on-farm measures are

implemented to prevent that feedingstuffs containing fishmeal are fed to

ruminants.

Conditions for the use of hydrolysed proteins derived from non-ruminants or

from ruminant hides and skins, and feedingstuffs containing such proteins, in the

feeding of non-ruminant farmed animals, with the exception of the feeding of

carnivorous fur producing animals.

(a) The hydrolysed proteins shall be produced in a processing plant

approved by the competent authority in accordance with article 17 of

European Union Regulation (EC) No 1774/2002.

(b) Feedingstuffs containing hydrolysed proteins shall be produced in

establishments which do not prepare feedingstuffs for ruminants and

which are authorised for this purpose by the competent authority.

However, by way of derogation from that condition -

(i)

a specific authorisation for the production of complete

feedingstuffs from feedingstuffs containing hydrolysed proteins is

not required for home compounders -

- registered by the competent authority,

- keeping only non-ruminants,

- producing complete feedingstuffs for use only in the same

holding, and,

- provided that the feedingstuffs containing hydrolysed

proteins used in the production contain less than 50% crude

protein;

(ii) the production of feedingstuffs for ruminants in establishments

which also produce feedingstuffs containing hydrolysed proteins

for other animal species may be authorised by the competent

authority subject to the following conditions -

- bulk and packaged feedingstuffs destined for ruminants are

manufactured in facilities physically separate from facilities

where feedingstuffs containing hydrolysed proteins are

manufactured,

- bulk feedingstuffs destined for ruminants are kept in facilities

physically separate from facilities where bulk hydrolysed

proteins and bulk feedingstuffs containing hydrolysed

proteins are kept during storage, transport and packaging,

- records detailing the purchases and uses of hydrolysed

proteins, and the sales of feedingstuffs containing hydrolysed

proteins are kept available to the competent authority for at

least five years.

(c) The label and the accompanying document of the feedingstuffs

containing hydrolysed proteins shall clearly indicate the words

"contains hydrolysed proteins - cannot be fed to ruminants".

(d) Bulk feedingstuffs containing hydrolysed proteins shall be transported

by means of vehicles which do not transport at the same time

feedingstuffs for ruminants. If the vehicle is subsequently used for the

transport of feedingstuffs intended for ruminants, it shall be thoroughly

cleaned in accordance with a procedure approved by the competent

authority to avoid cross-contamination.

(e) The use and storage of feedingstuffs containing hydrolysed proteins

shall be prohibited in farms where ruminants are kept.

By way of derogation from that condition, the competent authority may

permit the use and storage of feedingstuffs containing hydrolysed

proteins in farms where ruminants are kept, if they are satisfied that on-

farm measures are implemented to prevent the feeding of feedingstuffs

containing hydrolysed proteins to ruminants.

Conditions for the use of dicalcium phosphate, tricalcium phosphate and

feedingstuffs containing such proteins in the feeding of non-ruminant farmed

animals with the exception of the feeding of carnivorous fur producing animals.

(a) Dicalcium phosphate and tricalcium phosphate shall be produced in a

processing plant approved by the competent authority in accordance

with article 17 of European Union Regulation (EC) No 1774/2002.

(b) Feedingstuffs containing dicalcium phosphate or tricalcium phosphate

shall be produced in establishments which do not prepare feedingstuffs

for ruminants and which are authorised for this purpose by the

competent authority.

However, by way of derogation from that condition -

(i)

a specific authorisation for the production of complete

feedingstuffs from feedingstuffs containing dicalcium phosphate

or tricalcium phosphate is not required for home compounders -

- registered by the competent authority,

- keeping only non-ruminants,

- producing complete feedingstuffs for use only in the same

holding, and,

-

provided that the feedingstuffs containing dicalcium

phosphate or tricalcium phosphate used in the production

contain less than 10% total phosphorus;

(ii) the production of feedingstuffs for ruminants in establishments

which also produce feedingstuffs containing dicalcium phosphate

or tricalcium phosphate for other animal species may be

authorised by the competent authority subject to the following

conditions -

- bulk and packaged feedingstuffs destined for ruminants are

manufactured in facilities physically separate from facilities

where feedingstuffs containing dicalcium phosphate or

tricalcium phosphate are manufactured,

- bulk feedingstuffs destined for ruminants are kept in facilities

physically separated from facilities where bulk dicalcium

phosphate and bulk tricalcium phosphate and bulk

feedingstuffs containing dicalcium phosphate and tricalcium

phosphate are kept during storage, transport and packaging,

- records detailing the purchases and uses of dicalcium

phosphate or tricalcium phosphate and the sales of

feedingstuff containing dicalcium phosphate or tricalcium

phosphate are kept available to the competent authority for at

least five years.

(c) The label and accompanying document of the feedingstuffs containing

dicalcium phosphate or tricalcium phosphate shall clearly indicate the

words "contains dicalcium, tricalcium phosphate of animal origin -

cannot be fed to ruminants".

(d) Bulk feedingstuffs containing dicalcium phosphate or tricalcium

phosphate shall be transported by means of vehicles which do not

transport at the same time feedingstuffs for ruminants. If the vehicle is

subsequently used for the transport of feedingstuffs intended for

ruminants, it shall be thoroughly cleaned in accordance with a

procedure approved by the competent authority to avoid cross-

contamination.

(e) The use and storage of feedingstuffs containing dicalcium phosphate or

tricalcium phosphate shall be prohibited in farms where ruminants are

kept.

By way of derogation from that condition, the competent authority may

permit the use and storage of feedingstuffs containing dicalcium

phosphate or tricalcium phosphate in farms where ruminants are kept, if

they are satisfied that on-farm measures are implemented to prevent that

feedingstuffs containing dicalcium phosphate or tricalcium phosphate

are fed to ruminants.

Conditions for the use of blood products, bloodmeal and feedingstuffs

containing such proteins of non-ruminant origin in the feeding of farmed fish -

(a) the blood shall be derived from EU approved slaughterhouses not

slaughtering ruminants which are registered as not slaughtering

ruminants and shall be transported directly to the processing plant in

vehicles dedicated exclusively to the transport of non-ruminant blood.

If the vehicle was used for the transport of ruminant blood, it shall be,

following cleaning, inspected by the competent authority before the

transport of non-ruminant blood.

By way of derogation from that condition, the competent authority may

permit the slaughter of ruminants in slaughterhouses collecting non-

ruminant blood intended for the production of blood meal and blood

products for use in fish feed if these slaughterhouses have a recognised

control system. The control system shall at least include -

-

the slaughtering of non-ruminants physically separate from the

slaughtering of ruminants,

-

collection, storage, transport and packaging of blood from non-

ruminant origin in facilities physically separate from facilities

where blood of ruminant origin is collected, stored, transported

and packaged, and

-

regular sampling and analysis of blood from non-ruminant origin

for the presence of ruminant proteins;

(b) the blood products and the bloodmeal shall be produced in an

establishment exclusively processing non-ruminant blood and approved

by the competent authority in accordance with article 17 of European

Union Regulation (EC) No 1774/2002.

By way of derogation from that condition, the competent authority may

permit the production of blood products for use in fish feed in

establishments processing ruminant blood, which have a recognised

control system in place preventing cross-contamination. The control

system shall at least include -

-

processing of non-ruminant blood in a closed system physically

separate from the processing of ruminant blood,

-

transport, storage and packaging of bulk raw material and bulk

finished blood products of non-ruminant origin in facilities

physically separate from facilities where bulk raw material and

bulk finished products of ruminant origin are kept during storage,

transport and packaging, and,

-

regular sampling and analysis of non-ruminant blood products for

the presence of ruminant proteins;

(c) feedingstuffs containing blood products or bloodmeal shall be produced

in establishments manufacturing fish feed which do not prepare

feedingstuffs for other farmed animals, with the exception of

carnivorous fur producing animals, and which are authorised for that

purpose by the competent authority;

(d) the label, accompanying commercial document or health certificate, as

appropriate, of the feedingstuffs containing blood products or

bloodmeal shall clearly indicate the words "contains blood products -

shall only be fed to fish" or "contains bloodmeal - shall only be fed to

fish", as appropriate;

(e) transport vehicles used for the transport of bulk fish feed containing

blood products or bloodmeal shall not be used for the transport of

feedingstuffs for other farmed animals, with the exception of

carnivorous fur producing animals, unless the transport vehicle,

following cleaning, has been inspected by the competent authority;

(f)

the use and storage of fish feed containing blood products or bloodmeal

shall be prohibited in farms where other farmed animals, with the

exception of carnivorous fur producing animals, are kept.

3. II. General implementing conditions

A.

Member States shall make available to the other Member States and to the

European Commission an up-to-date list of EU approved slaughterhouses registered

as not slaughtering ruminants and approved processing establishments producing

hydrolysed proteins, dicalcium phosphate, tricalcium phosphate, fishmeal, blood

products or bloodmeal and establishments, with the exception of home

compounders, authorised for manufacturing feedingstuffs containing these proteins,

which operate in accordance with the conditions laid down by these regulations

within 60 days from the date of entry into force of these regulations. Any

amendments to the list shall immediately be made available to the other Member

States and to the European Commission.

B.

(a) Bulk processed animal protein, with the exception of fishmeal, and bulk

feedingstuffs containing such proteins, shall be stored and transported in

dedicated facilities. The store or vehicle can only be used for other

purposes, following cleaning, after having been inspected by the

competent authority.

(b) Bulk fishmeal, bulk hydrolysed proteins referred to in point A(a)(ii) of

part I, bulk dicalcium phosphate and bulk tricalcium phosphate referred

to in point A(a)(iii) of part I, and bloodmeal and blood products referred

to in point A(c) of part I shall be stored and transported in stores and

vehicles dedicated to that purpose.

(c) By way of derogation from point (b) -

(i)

stores or vehicles may be used for the storage and transport of

feedingstuffs containing the same protein;

(ii) stores or vehicles, following cleaning, may be used for other

purposes after having been inspected by the competent authority;

and,

(iii) vehicles transporting fishmeal may be used for other purposes if

the company has a control system in place, recognised by the

competent authority, to prevent cross-contamination. The control

system shall at least include -

- records on material transported and cleaning of the vehicle,

and

- regular sampling and analysis of feedingstuffs transported for

the presence of fishmeal.

The competent authority shall carry out frequent spot checks to verify the correct

application of the control plan.

C.

Feedingstuffs, including petfood, which contain processed animal proteins,

other than fishmeal or bloodmeal of non-ruminant origin, or blood products of

ruminant origin shall not be manufactured in establishments which produce

feedingstuffs for farmed animals, with the exception of carnivorous fur producing

animals.

Petfood and feedingstuffs intended for carnivorous fur producing animals

containing fishmeal, hydrolysed proteins referred to in point A(a)(ii) of part I,

dicalcium phosphate and tricalcium phosphate referred to in point A(a)(iii) of part I,

and bloodmeal and blood products referred to in point A(c) of part I shall be

manufactured and transported in accordance with the provisions referred to in points

B(c) and (e), C(b) and (d), D(b) and (d) and E(c) and (e), respectively of Part I.

D.

The export to third countries of processed animal proteins derived from

ruminants, and of products containing such processed animal proteins, shall be

prohibited.

The export of other processed animal proteins and blood products and products

containing such proteins shall only be permitted subject to the following conditions -

-

they are destined for uses not prohibited by article 7,

-

a written agreement with the third country is made prior to exportation,

which includes an undertaking from the third country to respect the

final use and not to reexport the processed animal protein, blood

products and products containing such proteins for uses prohibited by

article 7.

Member States which allow such exportation shall inform the European

Commission and the other Member States of all terms and conditions as agreed with

the third country concerned, for the effective implementation of these regulations, in

the context of the Standing Committee on the Food Chain and Animal Health.

The measures in this point shall not apply to fishmeal, provided it fulfils the

conditions set out in point B, products containing such fishmeal, and petfood.

E.

The competent authority shall carry out documentary and physical checks

including tests on feedingstuffs throughout the production and distribution chain in

accordance with European Union Council Directive 95/53/EC, to control compliance

with its provisions and the provisions of these regulations. Where any presence of

prohibited animal protein is detected, European Union Council Directive 95/53/EC

shall apply.

F.

The provisions on the production and the use of processed animal protein of

European Union Regulation (EC) No 1774/2002 shall apply to the feedingstuffs

covered by this Schedule.

(1) The BSE status of the territory of Malta, a Member

State, of a third country, or of one of their regions (hereinafter

referred to as ''countries or regions'') may be determined only on

the basis of the criteria set out in Schedule II, Chapter A, and the

outcome of a risk analysis on the basis of all the potential factors

for the appearance of bovine spongiform encephalopathy as defined

in Schedule II, Chapter B, and their development over time. The

territory of Malta, Member States and third countries wishing to be

retained on the list of third countries approved for the export to the

European Community of the live animals or of the products

covered by these regulations, shall submit to the European

Commission an application for their BSE status to be determined,

accompanied by the relevant information on the criteria set out in

Schedule II, Chapter A, and on the potential risk factors specified

in Schedule II, Chapter B, and their development over time.

(2) A decision on each application, placing the territory of

Malta, Member State or third country or region of the Member

State or third country which submitted the application in one of the

categories defined in Schedule II, Chapter C, shall be adopted,

taking account of the criteria and potential risk factors set out in

subregulation (1), in accordance with the procedure referred to in

regulation 24(2).

This decision shall be taken within six months of the

submission of the application and of the relevant information

referred to in subregulation (1). If the European Commission finds

that the supporting evidence does not include the information laid

down in Schedule II, Chapters A and B, it shall ask for additional

information to be provided within a period to be specified. The

fi nal decision shall then be taken within six months of the

submission of all information.

After the International Office of Epizootic Diseases (OIE)

has established a procedure for the classification of countries by

category and if it has placed the applicant country in one of those

categories, a reassessment of the European Community

categorisation of the country concerned in accordance with the first

paragraph of this subregulation may be decided, if appropriate, in

accordance with the procedure referred to in regulation 24(2).

(3) If the European Commission finds that the information

submitted by a Member State or a third country pursuant to

Schedule II, Chapters A and B, is insufficient or unclear, it may, in

accordance with the procedure referred to in regulation 24(2),

determine the BSE status of the territory of Malta, another Member

State or third country concerned on the basis of a full risk analysis.

Such a risk analysis must include a conclusive statistical

survey of the epidemiological situation regarding TSEs in the

applicant Member State or third country, on the basis of the use, in

a screening procedure, of rapid tests. The European Commission

shall take into account the classification criteria used by the OIE.

The rapid tests shall be approved for that purpose in

accordance with the procedure referred to in regulation 24(2) and

entered on a list set out in Schedule X, Chapter C, point 4.

Such screening procedure may also be used by Member

States or third countries which wish to have the classification they

carried out on that basis approved by the European Commission in

accordance with the procedure laid down in regulation 24(2).

The cost of such screening procedure shall be borne by the

Member State or third country concerned.

(4) The Veterinary Services shall notify the European

Commission as soon as possible of any epidemiological evidence

or other information which might lead to a change in BSE status, in

particular the results of the monitoring programmes provided for in

regulation 6.

(5) The retention of a third country on one of the lists provided

for by European Community rules for the purpose of being allowed

to export to the European Community live animals and products of

animal origin for which these regulations provides specific rules

shall be decided upon under the procedure laid down in regulation

24(2) and shall be made conditional in the light of the information

av ailable or where a T SE is presum ed to be present on t he

information provided for in subregulation (1) being supplied. In the

event of refusal to supply the said information within three months

of the date of the European Commission’s request, the relevant

European Community legislation provisions shall apply until this

information has been submitted and evaluated in accordance with

subregulations (2) or (3).

The eligibility of third countries to export to the European

Community live animals, or products of animal origin for which

these regulations provide specific rules, under conditions based on

their category as established by the European Commission, shall be

conditional upon their undertaking to notify the latter in writing as

soon as possible of any epidemiological or other evidence which

might lead to a change in BSE status.

(6) A decision may be taken, under the procedure laid down in

regulation 24(2), to change the BSE classification of a Member

State or third country, or of one of its regions, in accordance with

the results of the checks provided for in regulation 21.

(7) The decisions referred to in subregulations (2), (3), (5) and

(6) shall be based on a risk assessment, taking into consideration

the recommended criteria set out in Schedule II, Chapters A and B.

CHAPTER III

PREVENTION OF TSE

SPECIFIED RISK MATERIAL

1. The following tissues shall be designated as specified risk material

depending on the category of the Member State or third country of origin or

residence of the animal, determined in accordance with regulation 5 -

CATEGORIES 1 AND 2

None.

CATEGORIES 3 AND 4

(a) the skull including the brain and eyes, the tonsils and the spinal cord of

bovine animals aged over 12 months, and the intestines from the

duodenum to the rectum of bovine animals of all ages;

(b) the skull including the brain and eyes, the tonsils and the spinal cord of

ovine and caprine animals aged over 12 months or which have a

permanent incisor erupted through the gum, and the spleen of ovine and

caprine animals of all ages.

CATEGORY 5

(a) the entire head (excluding the tongue), including the brain, eyes,

trigeminal ganglia and tonsils; the thymus; the spleen and the spinal

cord of bovine animals aged over six months, and the intestines from

the duodenum to the rectum of animals of all ages;

(b) the vertebral column, including dorsal root ganglia, of bovine animals

aged over 30 months;

(c) the skull including the brain and eyes, the tonsils, the spinal cord of

ovine and caprine animals aged over 12 months or which have a

permanent incisor erupted through the gum, and the spleen of ovine and

caprine animals of all ages.

2. Specified risk material must be removed at -

(a) slaughterhouses;

(b) cutting plants, high-risk processing plants or premises referred to in

articles 3 and 7 of European Union Council Directive 90/667/EEC,

under the supervision of a designated agent appointed by the competent

authority. Those establishments shall be approved for that purpose by

the competent authority.

However, the vertebral column may be removed at points of sale to the consumer

situated in the territory of the Member State concerned.

Where specified risk material is not removed from dead animals which have not

been slaughtered for human consumption, the parts of the body containing specified

risk material or the entire body will be treated as specified risk material.

3. All specified risk material must be stained with a dye and, as appropriate,

marked with a marker immediately on removal, and completely destroyed -

(a) by incineration without pre-processing; or,

(b) provided that the dye or marker remains detectable, after pre-

processing -

(i)

in accordance with the systems described in Chapters I to IV, VI

and VII of the Annex to European Union Decision 92/562/EEC -

- by incineration;

- by coincineration;

(ii) in accordance with at least the standards referred to in Annex I to

European Union Decision 1999/534/EC, by burial in an approved

landfill site.

4. Member States may derogate from the provisions of points 2 and 3 to allow

the incineration or burial of specified risk material or entire bodies, without prior

staining, or, as appropriate, removal of the specified risk materials, in the

circumstances set out in article 3(2) of European Union Council Directive 90/667/

EEC and by a method which precludes all risk of transmission of a TSE and is

authorised and supervised by the competent authority, in particular where animals

have died or have been killed in the context of disease control measures and without

prejudice to articles 12 and 13.

5. 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.

6. Member States are to carry out frequent official inspections to verify the

correct application of this Schedule and ensure that measures are taken to avoid

contamination, particularly in slaughterhouses, cutting plants, animal waste

processing plants, high risk processing plants or premises authorised by the Member

States in accordance with article 7 of European Union Council Directive 90/667/

EEC, points of sale to the consumer, landfill sites and other facilities for storage or

incineration.

7. Member States shall in particular set up a system to ensure and check that -

(a) specified risk material used in the production of products referred to in

regulation 1(2) are used solely for the authorised purpose;

(b) where bovine, ovine or caprine animals enter a Member State placed in

a numerically lower category, indicating a better BSE status, than that

of the animals that enter, those animals remain under official

supervision until slaughter or dispatch from its territory;

(c) specified risk material, in particular where disposal takes place at

establishments or premises other than slaughterhouses, is completely

separated from other waste not destined for incineration, is collected

separately and is disposed of in accordance with points 2, 3 and 4.

Member States may allow dispatch of heads or carcassses containing

specified risk material to another Member State after agreement with

that other Member State both to receive the material and to apply the

specific conditions applicable to such movements.

8. Member States may send specified risk material or the material processed

therefrom to other Member States for incineration only under the conditions laid

down in article 4(2) of European Union Decision 97/735/EC, where applicable.

These points may be amended at the request of a Member State to allow the dispatch

of specified risk material or the material processed therefrom to third countries for

incineration. The conditions governing export shall be adopted at the same time, by

the same procedure.

(1) The Veterinary Services shall carry out an annual

programme for monitoring BSE and scrapie in accordance with

Schedule III, Chapter A. This 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 regulation 24(2) and listed in

Schedule X, Chapter C, point 4 and also in accordance with article

4 of the Veterinary Services Act.

(2) The Veterinary Services shall inform the European

Commission and the other Member States, within the Standing

Veterinary Committee, of the emergence of a TSE other than BSE.

(3) All official investigations and laboratory examinations

shall be recorded in accordance with Schedule III, Chapter B.

(4) The Veterinary Services shall submit an annual report to the

European Commission covering at least the information referred to

in Schedule III, Chapter B, Part I. The report for each calendar year

shall be submitted at the latest by 31 March of the following year.

The European Commission shall present a summary of the national

reports covering at least the information referred to in Schedule III,

Chapter B, Part II, to the Standing Veterinary Committee within

three months of the receipt of the said reports.

STANDARDS FOR CERTAIN PRODUCTS OF ANIMAL ORIGIN DERIVED

FROM OR CONTAINING RUMINANT MATERIAL

The use of ruminant material for the production of the following products of

animal origin is prohibited as referred to in regulation 9 (1) -

(a) mechanically recovered meat;

(b) dicalcium phosphate intended as feedingstuffs for livestock;

(c) gelatine, unless it is produced from ruminant hides;

(d) derivatives made from rendered ruminant fat;

(e) rendered ruminant fat, unless it was produced from -

(i) discrete adipose tissue declared fit for human consumption;

(ii) raw materials which were processed in accordance with the

standards referred to in European Union Council Directive 90/

667/EEC.

(1) The feeding to ruminants of protein derived from

mammals is prohibited.

(2) Furthermore, the prohibition referred to in subregulation

(1) shall be extended to animals and products of animal origin in

accordance with point 1 of Schedule IV.

(3) Subregulations (1) and (2) shall apply without prejudice to

the provisions set out in point 2 of Schedule IV.

(4)

(i) Member States, or regions thereof, in category 5 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 for

dogs and cats, which contains processed protein

derived from mammals.

(ii) Third countries, or regions thereof, in category 5 shall

not be permitted to export to the European Community

feed intended for livestock which contains protein

derived from mammals or feed intended for mammals,

except for dogs and cats, which contains processed

protein derived from mammals.

(5) Detailed rules for the implementation of this regulation, in

particular rules on the prevention of cross-contamination and on

the methods of sampling and analysis required to check compliance

with this regulation, shall be adopted in accordance with the

procedure referred to in regulation 24(2) and in accordance with

the provisions of the Veterinary Services Act.

ERADICATION OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY

1. The inquiry referred to in regulation 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 transmission, which may have

transmitted the TSE agent to or from the holding in question;

(b) in the case of ovine and caprine animals -

all ruminants other than ovine and caprine animals on the holding

of the animal in which the disease was confirmed,

in so far as they are identifiable, the parents, all embryos, ova and

the last progeny of the animal in which the disease was

confirmed,

all other ovine and caprine animals on the holding of the animal in

which the disease was confirmed in addition to those mentioned

in the second 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 BSE agent to or from the holding in question.

2. The measures laid down in regulation 13(1)(c) shall comprise at least -

(a) in case of confirmation of BSE in a bovine animal, the killing and

complete destruction of bovine animals identified by the inquiry

referred to in point 1(a), first, second and third indent. The Member

State may decide not to kill and destroy all bovine animals on the

holding of the animal in which the disease was confirmed as referred to

in the first indent of point 1(a), depending upon the epidemiological

situation and traceability of the animals on that holding;

(b) in the case of confirmation of TSE in an ovine or caprine animal,

according to the decision of the competent authority -

(i)

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); 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 1 ARR allele and no VRQ

allele, and,

- sheep carrying at least one ARR allele which are intended

solely for slaughter,

(iii) 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 the

measures to a single flock, based on a consideration of all the

epidemiological factors,

(c) in case of confirmation of BSE in an ovine or caprine animal, killing

and complete destruction of all animals, embryos and ova identified by

the inquiry referred to in the second to fifth indents of point 1(b).

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

destruction has been undertaken in accordance with point 2(b)(i) or (ii) -

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

(b) female sheep carrying at least 1 ARR allele and no VRQ allele;

(c) Caprine animals, provided that -

no ovine animals other than those of the ARR/ARR genotype are

present on the holding,

thorough cleaning and disinfection of all animal housing on the

premises has been carried out following de-stocking,

the holding shall be subjected to intensified TSE monitoring,

including the testing of all culled and dead-on-farm caprine

animals over the age of 18 months.

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

where destruction has been undertaken in accordance with point 2(b)(i) or (ii) -

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

(b) embryos carrying at least 1 ARR allele and no VRQ allele.

4. During a transitional period until 1 January 2006 at the latest, and by way of

derogation from the restriction set out in point 3(b), where it is difficult to obtain

replacement ovine animals of a known genotype, Member States may decide to

allow non-pregnant ewe lambs of an unknown genotype to be introduced to the

holdings referred to in point 2(b)(i) and (ii).

5. Following the application on a holding of the measures referred to in point

2(b)(i) and (ii) -

(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;

(c) sheep of other genotypes may only be moved from the holding for the

purposes of destruction.

6. The restrictions referred to in points 3 and 5 shall continue to apply to the

holding for a period of three 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) in the case of point 3.1(c), the date when the intensified TSE monitoring

commenced.

7. 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 -

(a) delay the destruction of animals as referred to in point 2(b)(i) and (ii)

for up to two breeding years;

(b) allow ovine animals other than those specified in point 3 to be

introduced to the holdings referred to in point 2(b)(i) and (ii), provided

that they do not carry a VRQ allele.

8. Members States applying the derogations referred to in points 4 and 7 shall

notify to the European Commission an account of the conditions and criteria used for

granting them.

(1) The specified risk material shall be removed and

destroyed in accordance with points 2, 3, 4 and 8 of Schedule V.

That specified risk material or the material processed therefrom

may be placed on the market or, if need be, exported only for final

destruction in accordance with points 3 and 4 or as appropriate 7(c)

or 8 of Schedule V. It may not be imported into the territory of

Malta. Transit of specified risk material through the European

Community territory must take place in accordance with the

requirements of article 3 of European Union Council Directive 91/

496/EEC.

(2) Subregulation (1) shall not apply to tissues from animals

which have undergone an alternative test approved for that distinct

purpose in accordance with rules found under the Veterinary

Services Act and the procedure referred to in regulation 24(2) and

listed in Schedule X, Chapter C, point 5, and applied under the

conditions listed in point 5 of Schedule V and where the results of

the test were negative. When the Veterinary Services will authorise

that alternative test, they must inform the other Member States and

the European Commission.

(3) In Member States, or regions thereof, which are placed in

categories 2, 3, 4 and 5 referred to in Schedule II, Chapter C, the

laceration, after stunning, of the central nervous tissue by means of

an elongated rod-shaped instrument introduced into the cranial

cavity shall not be used on bovine, ovine or caprine animals whose

meat is destined for human or animal consumption.

(4) The data relating to age set out in Schedule V shall be

adjusted regularly. Such adjustments shall be based on the latest

proven scientific findings concerning the statistical probability of

the occurrence of a TSE in the relevant age groups of the European

Community's bovine, ovine and caprine population.

(5) With regard to the date of effective enforcement of

regulation 7(1) or, as appropriate, in the third countries, the date of

banning the use of mammalian protein in feed for ruminants in each

country or region placed in category 3 or 4, in order to limit the

application of this regulation to animals born before that date in

those countries or regions, derogation from paragraph 1 to 4, may

be adopted -

(a) concerning the territory of Malta, in accordance with

the procedure referred to in article 11 of the Veterinary

Services Act;

(b) concerning third countries in accordance with the

procedure referred to in article 12 of the Veterinary

Services Act.

Similarly, by way of derogation from subregulation (1) to

(4), after consultation of the appropriate scientific committee and

on the basis of an assessment of the incident, propagation and

human exposure risk, a decision may be adopted in accordance

with the procedure referred to in regulation 24(2) and the relevant

rules found under the Veterinary Services Act to allow the use for

food, feed and fertilisers of vertebral column and dorsal root

ganglia from bovine animals in or coming from each country or

region thereof placed in category 5.

(6) Rules for the implementation of this regulation shall be

adopted in accordance with the procedure referred to in regulation

24(2) and -

(a) where the rules concern the territory of Malta, in

accordance with the procedure referred to in article 11

of the Veterinary Services Act,

(b) concerning third countries in accordance with the

procedure referred to in article 12 of the Veterinary

Services Act.

PLACING ON THE MARKET AND EXPORT

CHAPTER A

Conditions for intra-Community trade in live animals

Conditions which apply irrespective of the category of the Member State or

third country of origin or residence of the animal

The following conditions shall apply to trade in ovine and caprine animals -

(a) ovine and caprine animals for breeding shall either -

(i)

come from a holding which has satisfied the following

requirements for at least three years -

- it is subject to regular official veterinary checks,

- the animals are marked,

-

no case of scrapie has been confirmed,

-

checking by sampling of old female animals intended for

culling is carried out on the holding,

- females are introduced into that holding only if they come

from a holding which complies with the same requirements;

or

(ii) have been continuously kept on a holding or holdings complying

with the requirements laid down in point (i) since birth or for the

last three years; or

(iii) be animals of the ARR/ARR prion protein genotype, as defined in

Annex I of European Union Commission Decision 2002/1003/EC.

If they are destined for a Member State which benefits, for all or part of

its territory, from the provisions laid down in point (b) or (c), they shall

comply with the additional guarantees, general or specific, which have

been defined in accordance with the procedure referred to in regulation

24(2);

(b) a Member State which has a compulsory or voluntary national scrapie

control program for all or part of its territory -

(i)

may submit the said program to the European Commission,

outlining in particular -

- the distribution of the disease in the Member State,

- the reasons for the program, taking into consideration the

importance of the disease and the cost benefit ratio,

- the geographical area in which the program will be

implemented,

- the status categories defined for holdings and the standards

which must be attained in each such category,

- the test procedures to be used,

- the program monitoring procedures,

- the action to be taken if, for any reason, a holding loses its

status,

- the measures to be taken if the results of checks carried out in

accordance with the provisions of the program are positive,

(ii) the program referred to in point (i) may be approved if it complies

with the criteria laid down in that point, in accordance with the

procedure referred to in regulation 24(2). The additional

guarantees, general or specific, which may be required in intra-

Community trade, shall be defined at the same time or at the latest

three months after approval of the program in accordance with the

procedure referred to in regulation 24(2). Such guarantees must

not exceed those which the Member State implements nationally,

(iii) amendments or additions to the programmes submitted by

Member States may be approved in accordance with the

procedure referred to in regulation 24(2). Amendments to the

guarantees which have been defined in accordance with point (ii)

may be approved in accordance with that procedure;

(c) where a Member State considers that its territory or part of its territory

is free from scrapie -

(i)

it is to submit to the European Commission appropriate

supporting documentation, setting out in particular -

- the history of the occurrence of the disease in its territory,

- the results of surveillance testing based on serological,

microbiological,

pathological

or

epidemiological

investigation,

- the period over which the surveillance was carried out,

- the arrangements for verifying the absence of the disease,

(ii) the additional guarantees, general or specific, which may be

required in intra-Community trade are to be defined in accordance

with the procedure referred to in regulation 24(2). Such

guarantees must not exceed those which the Member State

implements nationally,

(iii) the Member State concerned is to notify the European

Commission of any change in the details specified in point (i)

which relate to the disease. The guarantees defined in accordance

with point (ii) may, in the light of such notification, be amended

or withdrawn in accordance with the procedure referred to in

regulation 24(2).

Conditions which apply depending on the category of the Member State of

origin or residence of the animal determined in accordance with Schedule II, Chapter

1. Dispatch to other Member States is to follow the rules of regulation 15(1).

2. The BSE category of the Member State of origin of bovine, ovine and

caprine animals are to be communicated to the Member State of destination.

3. The following conditions are to apply to movements as referred to in point 1

of bovine animals coming from or having resided in the Member States or one of the

regions thereof placed in -

CATEGORIES 3 AND 4

The animals must have -

(a) been born, raised and have remained in herds in which no case of BSE

has been confirmed for at least seven years; or,

(b) been born after the date from which the ban on the feeding of ruminants

with proteins derived from mammals has been effectively enforced.

CATEGORY 5

The animals must have -

(a) been born after the date from which the ban on the feeding of farmed

animals with proteins derived from mammals has been effectively

enforced; and,

(b) been born, raised and have remained in herds in which no case of BSE

has been confirmed for at least seven years, and which contain only

bovine animals born on the farm or coming from a herd of equivalent

status.

Conditions relating to progeny of TSE suspect or confirmed animals referred to in

It shall be prohibited to place on the market the lastborn progeny to which female

bovine animals infected with a TSE or BSE-confirmed ovine or caprine animals gave

birth during the preceding two year period or during the period that followed the

appearance of the first clinical signs of the onset of the disease.

CHAPTER C

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

I.

The following products of animal origin are exempt from the prohibition

referred to in regulation 16(3), provided that they are derived from bovine animals

that satisfy the requirements of Parts II or III below -

-

fresh meat;

-

minced meat;

-

meat preparations;

-

meat products;

-

petfood which is destined for domestic carnivores.

II.

DATE-BASED SCHEME

Deboned fresh meat from which all adherent tissues, including obvious nervous

and lymphatic tissue, has been removed, and products of animal origin referred to in

Part I deriving therefrom obtained from eligible animals from countries or regions in

category 5 may be marketed in accordance with the second subparagraph of

regulation 16(3) when they are obtained from animals born after the date from which

the animal feeding standards laid down in regulation 7(2) were effectively enforced

and certified as meeting the conditions laid down in point 1 and they are produced in

establishments which meet the condition laid down in point 9. The competent

authority shall ensure that the conditions with respect to controls laid down in points

2 to 8 and point 10 are complied with.

1. A bovine animal shall be eligible for the Date-based Scheme if it was born

and raised in the Member State concerned and if at the time of slaughter it is shown

that the following conditions are fulfilled -

(a) the animal has been clearly identifiable throughout its life, enabling it to

be traced back to its dam and herd of origin; its unique ear-tag number,

date and holding of birth and all movements after birth are recorded

either in the animal’s official passport or in an official computerised

identification and tracing system; the identity of its dam is known;

(b) the animal is more than six months but less than 30 months of age,

determined by reference to an official computer record of its date of

birth, or to the animal’s official passport;

(c) the competent authority has obtained and verified positive evidence that

the dam of the animal has lived for at least six months after the birth of

the eligible animal;

(d) the dam of the animal has not developed BSE and is not suspected of

having contracted BSE.

CONTROLS

2. If any animal presented for slaughter or any circumstance surrounding its

slaughter does not meet all of the requirements of these regulations, the animal must

be automatically rejected and its passport confiscated. If that information becomes

available after slaughter, the competent authority must immediately cease issuing

certificates and cancel certificates issued. If dispatch has already taken place, the

competent authority must notify the competent authority of the place of destination.

The competent authority of the place of destination must take the appropriate

measures.

3. Slaughter of eligible animals must take place in slaughterhouses which are

not used for the slaughter of bovine animals other than those slaughtered under a

Datebased Scheme or under a Certified Herd Scheme.

4. The competent authority must satisfy itself that procedures used in the

cutting plants ensure that the following lymph nodes have been removed -

popliteal, ischiatic, superficial inguinal, deep inguinal, medial and

lateral iliac, renal, prefemoral, lumbar, costocervical, sternal,

prescapular, axilliary, caudal and deep cervical.

5. Meat must be traceable back to the eligible animal, or after cutting, to the

animals cut in the same batch, by means of an official tracing system until the time

of slaughter. After slaughter, labels must be capable of tracing fresh meat and

products referred to in Part I back to the eligible animal to enable the consignment

concerned to be recalled. In the case of petfood, accompanying documents and

records must allow tracing.

6. All approved eligible carcasses must have individual numbers correlated

with the ear-tag number.

7. The Member State must have detailed protocols in place covering -

(a) tracing and controls prior to slaughter;

(b) controls during slaughter;

(c) controls during processing of petfood;

(d) all labelling and certification requirements after slaughter to the point of

sale.

8. The competent authority must set up a system for recording checks on

compliance so that control can be demonstrated.

THE ESTABLISHMENT

9. To obtain approval, the establishment must devise and implement a system

whereby the eligible meat and, or eligible product is identifiable and all meat can be

traced back to the eligible animal, or after cutting, to the animals cut in the same

batch. The system must allow full traceability of the meat or products of animal

origin at all stages and records must be retained for at least two years. Details of the

system employed must be given, in writing, by the management of the establishment

to the competent authority.

10. The competent authority must assess, approve and monitor the system

provided by the establishment in order to ensure that it provides full segregation and

traceability both backwards and forwards.

III.

CERTIFIED HERD SCHEME

Deboned fresh meat from which all adherent tissues, including obvious lymphatic

and nervous tissue, has been removed, and products of animal origin referred to in

Part I, deriving therefrom which are obtained from eligible animals from countries

or regions i n category 5, m ay be marketed in accordance with the second

subparagraph of regulation 16(3) when obtained from animals which are certified as

meeting the conditions laid down in point 2 and coming from herds in which no case

of BSE has occurred in the last seven years and which are certified as meeting the

conditions laid down in point 1 and produced in establishments which meet the

condition laid down in point 11.

The competent authority shall ensure that the conditions laid down in points 3 to

10 and 12 with respect to the computerised tracing system and the controls are

complied with.

Conditions relating to herds -

1. (a) A herd is a group of animals forming a separate and distinct unit, that is

a group of animals which is managed, housed and kept separately from

any other group of animals and which is identified with unique herd and

animal identification numbers.

(b) A herd is eligible when for at least seven years there has been no

confirmed case of BSE, nor a suspect case for which the diagnosis of

BSE has not been ruled out, in any animal which was still in or had

moved through or from the herd.

(c) As an exception to the provisions in point (b), a herd that has been in

existence for less than seven years may be considered eligible, after a

thorough investigation by the competent veterinary authority, on

condition that -

(i)

all animals born or moved into the newly established herd

complied with the conditions set out in point (2)(a), (d) and (e);

and,

(ii) the herd has complied with the conditions set out in point (b)

during its entire existence.

(d) If a herd is newly established on a holding which experienced a

confirmed case of BSE in any animal which was still in or had moved

through or from a herd on that holding, the newly established herd can

only be eligible after a thorough investigation by the competent

veterinary authority, certifying compliance with each of the following

conditions to the satisfaction of that authority -

(i)

all animals of the affected herd previously held on the same

holding have been removed or killed;

(ii) all feed has been removed and destroyed and all feed containers

thoroughly cleansed;

(iii) all buildings have been emptied and thoroughly cleansed before

the new animals were admitted;

(iv) all conditions set out in point (c) have been complied with.

Conditions relating to the animal -

2. (a) all records of the animal’s birth, identity and movements are recorded on

an official computerised tracing system;

(b) the animal is more than six months but less than 30 months of age,

determined by reference to an official computer record of its date of

birth;

(c) its dam has lived for at least six months after its birth;

(d) its dam has not developed BSE and is not suspected of having

contracted BSE;

(e) the herd of birth of the animal and all herds through which it has moved

are eligible.

Computerised tracing system

3. The official computerised tracing system referred to in point 2 (a) will be

approved only where it has been in operation for sufficient time to contain all the

information, relating to the lifetime and movements of the animals, needed to check

compliance with the requirements of these regulations, and concerns only animals

born after the system came into operation. Historical data loaded into a computer for

any period before the system was operational will not be accepted for this purpose.

Controls

4. If any animal presented for slaughter or any circumstance surrounding its

slaughter does not meet all of the requirements of these regulations, the animal must

be automatically rejected and its passport confiscated. If that information becomes

available after slaughter, the competent authority must immediately cease issuing

certificates, and cancel certificates issued. If dispatch has already taken place, the

competent authority must notify the competent authority of the place of destination.

The competent authority of the place of destination must take the appropriate

measures.

5. Slaughter of eligible animals must take place in slaughterhouses used

exclusively for the slaughter of animals under a Date-based Scheme or under a

Certified Herd Scheme.

6. The competent authority must satisfy itself that procedures used in the

cutting plants ensure that the following lymph nodes have been removed -

popliteal, ischiatic, superficial inguinal, deep inguinal, medial and

lateral iliac, renal, prefemoral, lumbar, costocervical, sternal,

prescapular, axilliary, caudal and deep cervical.

7. Meat must be traceable back to the herd of the eligible animal, or after

cutting, to the animals cut in the same batch, by means of the computerised tracing

system until the time of slaughter. After slaughter, labels must be capable of tracing

fresh meat and products referred to in Part I back to the herd to enable the

consignment concerned to be recalled. In the case of petfood, accompanying

documents and records must allow tracing.

8. All approved eligible carcassses must have individual numbers correlated

with the eartag number.

9. The Member State must have detailed protocols in place covering -

(a) tracing and controls prior to slaughter;

(b) controls during slaughter;

(c) controls during processing of petfood;

(d) all labelling and certification requirements after slaughter to the point of

sale.

10. The competent authority must set up a system for recording checks on

compliance so that control can be demonstrated.

The establishment

11. To obtain approval, the establishment must devise and implement a system

whereby the eligible meat and, or eligible product is identifiable and all meat can be

traced back to its herds of origin, or after cutting, to the animals cut in the same

batch. The system must facilitate full traceability of the meat or products of animal

origin at all stages and records must be retained for at least two years.

Details of the system employed must be given, in writing, by the management of

the establishment to the competent authority.

12. The competent authority must assess, approve and monitor the system

provided by the establishment in order to ensure that it provides full segregation and

traceability both backwards and forwards.

CHAPTER D

Conditions applicable to exports of live bovine animals and products of animal

origin derived therefrom are to be subject - as regards exports to third countries to

the rules laid down in these regulations for intra-Community trade.

(1) In the territory of Malta the products of animal origin

listed in Schedule VI shall not be produced from ruminant material

from countries or regions thereof which are placed in category 5

unless they are produced in accordance with the production

processes approved in accordance with the procedure referred to in

regulation 24(2) and in accordance with article 11 of the Veterinary

Services Act.

(2) Bones of the head and vertebral columns of bovine, ovine

and caprine animals from countries, or regions thereof, which are

p l a c e d i n c a t e g o r i e s 2 , 3 , 4 o r 5 , s h a l l n o t b e u s e d f o r th e

production of mechanically recovered meat.

(3) Subregulations (1) and (2) shall not apply, in the light of the

criteria set out in point 5 of Schedule V, to ruminants which have

undergone an alternative test which has been recognised in

accordance with the rules found under the Veterinary Services Act

and the procedure referred to in regulation 24(2), where the results

of the test were negative.

(4) Rules for the implementation of this regulation shall be

adopted in accordance with the procedure referred to in regulation

24(2) and if the rules -

(a) concern the territory of Malta the procedure referred to

in article 11 of the Veterinary Services Act shall apply;

(b) concern third countries in accordance with the

procedure referred to in article 12 of the Veterinary

Services Act.

IMPORTATION INTO THE COMMUNITY OF LIVE ANIMALS, EMBRYOS, OVA

AND PRODUCTS OF ANIMAL ORIGIN

CHAPTER A

When importing from countries or regions placed in category 1, the competent

authority is, for bovine animals and all commodities of bovine origin for which these

regulations lays down specific rules, to take account of the presentation of an

international animal health certificate attesting that the country or region complies

with the conditions in Schedule II, Chapter C, to be placed in that category.

CHAPTER B

Imports of bovine animals

A.

Imports of bovine animals from a country or a region placed in category 2

are to be subject to the presentation of an international animal health certificate

attesting that -

(a) the feeding of ruminants with proteins derived from mammals has been

banned and the ban has been effectively enforced;

(b) the bovine animals intended for export to the European Community are

identified by a permanent identification system enabling them to be

traced back to the dam and herd of origin and are not the progeny of

BSE-suspected females.

B.

Imports of bovine animals from countries or regions placed in category 3 are

to be subject to the presentation of an international animal health certificate attesting

that -

1. the feeding of ruminants with proteins derived from mammals has been

banned and the ban has been effectively enforced;

2. bovine animals intended for export to the European Community -

-

are identified by a permanent identification system enabling them to be

traced back to the dam and herd of origin and making it possible to

establish that they are not the progeny of BSE suspect or confirmed

females;

-

were born, raised and had remained in herds in which no case of BSE

had been confirmed for at least seven years; or,

-

were born after the date from which the ban on the feeding of ruminants

with proteins derived from mammals has been effectively enforced.

Imports of bovine animals from countries or regions placed in category 4 are

to be subject to the presentation of an international animal health certificate attesting

1. the feeding of ruminants with proteins derived from mammals has been

banned and the ban has been effectively enforced;

2. bovine animals intended for export to the European Community -

(a) are identified by a permanent identification system enabling them to be

traced back to the dam and herd of origin and making it possible to

establish that they are not the progeny of BSE suspect or confirmed

females; and

(b) were born, raised and have remained in herds in which no case of BSE

has been confirmed for at least seven years; or

(c) were born after the date from which the ban on the feeding of ruminants

with proteins derived from mammals has been effectively enforced.

Imports of bovine animals from countries or regions placed in category 5 are

to be subject to the presentation of an international animal health certificate attesting

1. the feeding of farmed animals with proteins derived from mammals has been

banned and the ban has been effectively enforced;

2. the affected bovine animals are killed and completely destroyed as well as -

(a) if these are females, their last progeny born within two years prior to, or

after the first clinical signs of the onset of the disease;

(b) all bovine animals from the same cohort if such animals are still alive in

the country or region;

3. the animals intended for export to the European Community -

(a) were born after the date from which the ban on the feeding of farmed

animals with proteins derived from mammals was effectively enforced;

(b) are identified by a permanent identification system enabling them to be

traced back to the dam and herd of origin and are not the progeny of

BSE suspect or confirmed females; and,

(c) either were born, raised and have remained in herds in which no case of

BSE has ever been confirmed, and which contain only bovine animals

born on the farm or coming from a herd of equal health status; or

(d) were born, raised and have remained in herds in which no case of BSE

has been confirmed for at least seven years, and which contain only

bovine animals born on the farm or coming from a herd of equal health

status.

CHAPTER C

Imports of fresh meat and products of bovine animal origin

Imports of fresh meat (on the bone or de-boned) and products of bovine

animal origin from countries or regions placed in category 2 are to be subject to the

presentation of an international health certificate attesting that the feeding of

ruminants with proteins derived from mammals has been banned and the ban has

been effectively enforced.

Imports of fresh meat (on the bone or de-boned) and products of bovine

animal origin from countries or regions placed in category 3 are to be subject to the

presentation of an international health certificate attesting that -

(a) the feeding of ruminants with proteins derived from mammals has been

banned and the ban has been effectively enforced;

(b) the fresh meat and products of bovine animal origin intended for export

to the European Community do not contain or are not derived from

specified risk material referred to in Schedule V or mechanically

recovered meat obtained from the bone of the head or vertebral column.

C.

Imports of fresh meat (on the bone or de-boned) and meat products of

bovine origin from countries or regions placed in category 4 are to be subject to the

presentation of an international health certificate attesting that -

1. the feeding of ruminants with proteins derived from mammals has been

banned and the ban has been effectively enforced;

2. the fresh meat and products of bovine animal origin intended for export to

the European Community do not contain or are not derived from specified risk

material referred to in Schedule V or mechanically recovered meat obtained from the

head or vertebral column.

D.

Imports of fresh meat and products of bovine animal origin from countries

or regions placed in category 5 are to be prohibited except for the products of animal

origin listed in section I of Chapter C, Schedule VIII. These imports are to be subject

to the presentation of an international health certificate attesting that -

1. they fulfil the conditions of regulation 16 (2) and those set out in sections II

or III of Chapter C of Schedule VIII;

2. the meat products intended for export to the European Community do not

contain or are not derived from any product referred to in Chapter F, nor from any

specified risk material as defined in Schedule V;

3. a system is in operation enabling the fresh meat and products of bovine

animal origin intended for export to the European Community to be traced back to

the establishments from which they are derived;

4. the bovine animals from which the meat or meat products intended for

export to the European Community -

(a) were identified by a permanent identification system enabling them to

be traced back to the dam and herd of origin;

(b) are not the progeny of BSE-suspect or confirmed females;

and either -

-

were born after the date from which the ban on the feeding of

farmed animals with proteins derived from mammals was

effectively enforced; or

-

were born, raised and have remained in herds in which no case of

BSE has been confirmed for at least seven years;

5. the feeding of farmed animals with proteins derived from mammals has been

banned and the ban has been effectively enforced;

6. the affected bovine animals are slaughtered and completely destroyed as

well as -

(a) if these are females, their last progeny born within two years prior to, or

after, the first clinical signs of the onset of the disease;

(b) all bovine animals from the same cohort if they are still alive in the

country or region.

CHAPTER D

Imports of bovine embryos and ova

Imports of bovine embryos, ova from countries or regions placed in category

2 are to be subject to the presentation of an international animal health certificate

attesting that -

1. the feeding of ruminants with proteins derived from mammals has been

banned and the ban has been effectively enforced;

2. the embryos, ova were collected, processed and stored in conformity with

the provisions of Annexes A and B to European Union Council Directive 89/556/EC.

Imports of bovine ova, embryos from countries or regions placed in category

3 are to be subject to the presentation of an international animal health certificate

attesting that -

1. the feeding of ruminants with proteins derived from mammals has been

banned and the ban has been effectively enforced;

2. ova, embryos destined for export to the European Community are derived

from females which -

(a) are identified by a permanent identification system enabling them to be

traced back to the dam and herd of origin, and are not the progeny of

BSE-confirmed females;

(b) are not the progeny of BSE-suspect or confirmed females;

(c) were not suspected of being affected by BSE at the time of embryo

collection;

3. the ova, embryos were collected, processed and stored in accordance with

the provisions of Annexes A and B to European Union Council Directive 89/556/

Imports of ova, embryos from countries or regions placed in category 4 are

to be subject to the presentation of an international animal health certificate attesting

1. the feeding of ruminants with proteins derived from mammals has been

banned and the ban has been effectively enforced;

2. the ova, embryos intended for export to the European Community are

derived from females which -

(a) are identified by a permanent identification system enabling them to be

traced back to the dam and herd of origin, and are not the progeny of

BSE-suspected or affected females;

(b) are not affected with BSE;

(c) were not suspected of being affected with BSE at the time of embryo

collection; and

(i)

either were born after the date from which the ban on the feeding

of ruminants with proteins derived from mammals was effectively

enforced; or

(ii) were born, raised and have remained in herds in which no case of

BSE has been confirmed for at least seven years;

3. the ova, embryos were collected, processed and stored in conformity with

the provisions of Annexes A and B to European Union Council Directive 89/556/

EEC.

D.

Imports of bovine ova, embryos from countries or regions placed in category

5 are to be subject to the presentation of an international animal health certificate

attesting that -

1. the feeding of animals for breeding with proteins derived from mammals has

been banned and the ban has been effectively enforced;

2. the affected bovine animals, and, if these are females, their last progeny

born within two years prior to, or after, clinical onset of the disease, if alive in the

country or region, are killed and completely destroyed;

3. ova, embryos intended for export to the European Community are derived

from females which -

(a) are identified by a permanent identification system enabling them to be

traced back to the dam and herd of origin, and are not the progeny of

BSE-suspected or confirmed females;

(b) are not affected with BSE;

(c) were not suspected of being affected with BSE at the time of embryo

collection; and

(i)

either were born after the date from which the ban on the feeding

of animals for breeding with proteins derived from mammals was

effectively enforced;

(ii) or have never been fed with proteins derived from mammals and

were born, raised and have remained in herds in which no case of

BSE has been confirmed for at least seven years, and which

contain only bovine animals born on the farm or coming from a

herd of equal health status;

4. the ova, embryos were collected, processed and stored strictly in conformity

with the provisions of Annexes A and B to European Union Council Directive 89/

556/EEC.

CHAPTER E

Imports of ovine and caprine animals

Ovine and caprine animals imported into the European Community are to be

subject to the presentation of an animal health certificate attesting that -

(a) either they were born in and continuously reared on holdings in which a

case of scrapie has never been diagnosed, and, in the case of ovine and

caprine animals for breeding, they satisfy the requirements of

subparagraphs (i) and (ii) of point (a) of Chapter A(I) of Schedule VIII;

(b) or they are sheep of the ARR/ARR prion protein genotype, as defined in

Annex I to European Union Commission Decision 2002/1003/EC,

coming from a holding where no case of scrapie has been reported in the

last six months.

If they are destined for a Member State which benefits, for all or part of its

territory, from the provisions laid down in point (b) or (c) of Chapter A(I) of

Schedule VIII, they shall comply with the additional guarantees, general or specific,

which have been defined in accordance with the Veterinary Services Act and the

procedure referred to in regulation 24(2).

CHAPTER F

Imports into the European Community from third countries or regions thereof,

placed in category 5, of the products of animal origin referred to in Schedule VIII,

Chapter C, in accordance with regulation 16(3) are to be prohibited if they contain or

are derived from the following products or material derived from ruminant animals -

-

mechanically recovered meat;

-

dicalcium phosphate intended for feeding livestock;

-

gelatine unless produced from hides or skins;

-

rendered ruminant fat and derivatives made from it unless they were

produced from discrete adipose tissue which was itself declared fit for

human consumption, or from raw materials which were processed in

accordance with the standards referred to in European Union Decision

1999/534/EC.

CHAPTER G

When importing products of animal origin from third countries or regions thereof

which are not placed in category 1, the appropriate certificates, as required by

European Community legislation, are to be supplemented by a declaration signed by

the competent authority of the country of production, worded as follows -

''The product of animal origin does not contain, and is not derived from, specified

risk material as defined in Annex V 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 or mechanically recovered meat obtained from bones of the head

or vertebral column of bovine animals. The animals have not been slaughtered after

stunning by means of a gas injected into the cranial cavity or killed instantaneously

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.''.

(1) The territory of Malta shall ensure that staff of the

Veterinary Services, of diagnostic laboratories and colleges of

agriculture and veterinary medicine, official veterinarians,

veterinary practitioners, slaughterhouse personnel and animal

breeders, keepers and handlers have been given training in the

clinical signs, epidemiology and in the case of staff responsible for

carrying out checks, in interpreting laboratory findings relating to

TSEs.

(2) To ensure effective implementation of the education

programmes provided for in subregulation (1), financial assistance

from the European Community may be granted. The amount of

such assistance shall be determined in accordance with the

procedure referred to in regulation 24(2).

CHAPTER IV

CONTROL AND ERADICATION OF TSEs

REFERENCE LABORATORIES, SAMPLING AND

LABORATORY ANALYSIS METHODS

CHAPTER A

National reference laboratories

1. The designated national reference laboratory is to -

(a) have at its disposal facilities and expert personnel enabling it to show at

all times, and especially when the disease in question first appears, the

type and strain of the agent of TSE, and to confirm results obtained by

regional diagnostic laboratories. Where it is not capable of identifying

the strain-type of the agent, it shall set up a procedure to ensure that the

identification of the strain is referred to the European Community

reference laboratory;

(b) verify diagnostic methods used in regional diagnostic laboratories;

(c) be responsible for co-ordination of diagnostic standards and methods

within the Member State. To this end, it -

-

may provide diagnostic reagents to laboratories approved by the

Member State;

-

is to control the quality of all diagnostic reagents used in the

Member State;

-

is to periodically arrange comparative tests;

-

is to hold isolates of the agents of the disease in question, or

corresponding tissues containing such agents, coming from cases

confirmed in the Member State;

-

is to ensure confirmation of results obtained in diagnostic

laboratories designated by the Member State;

(d) is to co-operate with the European Community reference laboratory.

2. However, by way of derogation from point 1, Member States which do not

have a national reference laboratory are to use the services of the European

Community reference laboratory or of national reference laboratories in other

Member States.

3. The national reference laboratories are -

Austria -

Bundesanstalt für Tierseuchenbekämpfung, Mödling Robert Koch Gasse 17

A2340 Mödling

Belgium -

C E RVA C O D AVA R C e n t r e d ' É t u d e e t d e R e c h e r c h e s V é t é r i n a i r e s e t

Agrochimiques Centrum voor Onderzoek in Diergeneeskunde en Agrochemie

Veterinary and Agrochemical Research Centre Groeselenberg 99 B1180 Bruxelles.

Denmark -

Danish Veterinary Laboratory Bülowsvej 27 DK1790 Copenhagen V.

Finland -

Eläinlääkintä- ja elintarvikelaitos Hämeentie 57 FIN00550 Helsinki.

France -

Agence Française de Sécurité‚ Sanitaire des Aliments Laboratoire de pathologie

bovine 31, avenue Tony Garnier BP 7033 F69342 Lyon Cedex.

Germany -

Bundesforschungsanstalt für Viruskrankheiten der Tiere Anstaltsteil Insel Riems

Boddenblick 5A D17498 Insel Riems.

Greece -

Greece Ministry of Agriculture; Veterinary Laboratory of Larisa; 7th km of Larisa

- Trikala Highway GR-411 10 Larisa (rapid tests and immunological tests).

Laboratory of Gross Pathology; Faculty of Veterinary Medicine; Aristotelian

University of Thessaloniki; Giannitson & Voutyra St. GR-546 27 Thessaloniki

(histopathology).

Ireland -

Central Veterinary Research Laboratory, Abbotstown, Castleknock, Dublin 15,

Ireland.

Italy -

Istituto Zooprofilattico Sperimentale del Piemonte Liguria e Valle d'Aosta CEA

Via Bologna I14810150 Torino.

Luxembourg -

C E RVA C O D AVA R C e n t r e d ' É t u d e e t d e R e c h e r c h e s V é t é r i n a i r e s e t

Agrochimiques Centrum voor Onderzoek in Diergeneeskunde en Agrochemie

Veterinary and Agrochemical Research Centre Groeselenberg 99 B1180 Bruxelles.

Netherlands -

Instituut voor Dierhouderij en Diergezondheid, IDDLO Lelystad Edelhertweg 15

Postbus 65 8200 AB Lelystad Netherlands.

Portugal -

Laboratório Nacional de Investigaçäo Veterinária Estrada de Benfica, 701 P1500

Lisboa.

Spain -

Laboratorio de la Facultad de Veterinaría Departamento de Patología Animal

(Anatom¡a Patológíca) Zaragoza Spain (BSE and scrapie, methods other than rapid

tests)

Laboratorio Central de Veterinaria de Algete Madrid Spain (rapid tests)

Centro de Investigacion en Sanidad An¡mal (CISA) Crta, De Algete al Casar de

Talamanca 28130 Valdeolmos (Madrid) Spain (TSEs other than BSE or scrapie).

Sweden -

National Veterinary Institute S751 89 Uppsala.

United Kingdom -

United Kingdom Veterinary Laboratories Agency Woodham Lane New Haw

Addlestone Surrey KT15 3NB.

CHAPTER B

Community reference laboratory

1. The European Community reference laboratory for TSEs is -

The Veterinary Laboratories Agency

Woodham Lane

New Haw

Addlestone

Surrey

KT15 3NB

United Kingdom

2. The functions and duties of the European Community reference laboratory

are -

(a) to co-ordinate, in consultation with the European Commission, the

methods employed in the Member States for diagnosing BSE,

specifically by -

-

storing and supplying corresponding tissues containing the agent,

for the development or production of the relevant diagnostic tests

or for typing strains of the agent;

-

supplying standard sera and other reference reagents to the

national reference laboratories in order to standardise the tests

and reagents used in the Member States;

-

building up and retaining a collection of corresponding tissues

containing the agents and strains of TSEs;

-

organising periodic comparative tests of diagnostic procedures at

European Community level;

-

collecting and collating data and information on the methods of

diagnosis used and the results of tests carried out in the European

Community;

-

characterising isolation of the TSE agent by the most up-to-date

methods to allow greater understanding of the epidemiology of

the disease;

-

keeping abreast of trends in surveillance, epidemiology and

prevention of TSEs throughout the world;

-

maintaining expertise on prion diseases to enable rapid

differential diagnosis;

-

acquiring a thorough knowledge of the preparation and use of

diagnostic methods used to control and eradicate TSEs;

(b) to assist actively in the diagnosis of outbreaks of TSEs in Member

States by studying samples from TSE-infected animals sent for

confirmatory diagnosis, characterisation and epidemiological studies;

(c) to facilitate the training or retraining of experts in laboratory diagnosis

with a view to the harmonisation of diagnostic techniques throughout

the European Community.

CHAPTER C

Sampling and laboratory testing

1. Sampling

Any samples intended to be examined for the presence of a TSE shall be collected

using the methods and protocols laid down in the latest edition of the Manual of

standards for diagnostic tests and vaccines of the International Office for Epizooties

(IOE/OIE) (hereinafter referred to as ''the Manual'').

In the absence of such methods and protocols, the samples shall be collected in a

manner appropriate for the correct application of tests. The samples shall be

correctly marked as to the identity of the sampled animal.

2. Laboratories

Any laboratory examination for TSE shall be carried out in laboratories approved

for that purpose.

3. Methods and protocols

3.1. Laboratory testing for the presence of BSE in bovine animals

(a) Suspect cases

Tissues from bovine animals sent for laboratory testing pursuant to the

provisions of regulation 12(2) shall be subject to a histopathological

examination as laid down in the latest edition of the Manual, except

where the material is autolysed. Where the result of the

histopathological examination is inconclusive or negative or where the

material is autolysed, the tissues shall be subjected to an examination by

one of the other diagnostic methods laid down in the Manual (immuno-

cytochemistry, immuno-blotting or demonstration of characteristic

fibrils by electron microscopy). However, rapid tests cannot be used for

this purpose.

If the result of one of the above examinations is positive, the animals

shall be regarded a positive BSE case.

(b) BSE monitoring

Tissues from bovine animals sent for laboratory testing pursuant to the

provisions of Schedule III, Chapter A, Section I (Monitoring in bovine

animals) shall be examined by a rapid test.

When the result of the rapid test is inconclusive or positive, the tissues

shall immediately be subject to confirmatory examinations in an official

laboratory. The confirmatory examination shall start by a

histopathological examination of the brainstem as laid down in the

latest edition of the Manual, except where the material is autolysed or

otherwise not suitable for examination by histopathology. Where the

result of the histopathological examination is inconclusive or negative

or where the material is autolysed, the tissues shall be subjected to an

examination by one of the other diagnostic methods mentioned under

(a).

An animal shall be regarded a positive BSE case if the result of the

rapid test is positive or inconclusive, and,

-

the result of the subsequent histopathological examination is

positive, or,

-

the result of another diagnostic method mentioned under (a) is

positive.

3.2. Laboratory testing for the presence of scrapie in ovine and caprine animals

(a) Suspect cases

Tissues from ovine and caprine animals sent for laboratory testing

pursuant to the provisions of regulation 12(2) shall be subject to a

histopathological examination as laid down in the latest edition of the

Manual, except where the material is autolysed. Where the result of the

histopathological examination is inconclusive or negative or where the

material is autolysed, the tissues shall be subjected to an examination by

immuno-cytochemistry or immuno-blotting, as laid down in the

Manual. However, rapid tests cannot be used for this purpose.

If the result of one of the above examinations is positive, the animal

shall be regarded a positive scrapie case.

(b) Scrapie monitoring

Tissues from ovine and caprine animals sent for laboratory testing

pursuant to the provisions of Schedule III, Chapter A, Section II

(Monitoring in ovine and caprine animals) shall be examined by a rapid

test.

When the result of the rapid test is inconclusive or positive, the

brainstem shall immediately be sent to an official laboratory for

confirmatory examinations by immuno-cytochemistry or immuno-

blotting, as referred to under (a).

An animal shall be regarded a positive scrapie case if the result of the

confirmatory examination is positive.

3.3. Laboratory testing for the presence of TSEs other than those referred to in

points 3.1 and 3.2

The tests carried out to confirm the suspected presence of a TSE different from

those referred to in points 3.1 and, 3.2 shall include at least a histopathological

examination of brain tissue. The competent authority may also require laboratory

t e s t s s u c h a s i m m u n o - c y t o c h e m i s t r y, i m m u n o - b l o t t i n g , d e m o n s t r a t i o n o f

characteristic fibrils by electron microscopy or other methods designed to detect the

disease associated form of the prion protein. In any case at least one other laboratory

examination shall be carried out if the initial histopathological examination is

negative or inconclusive. At least three different examinations shall be carried out in

the event of the first appearance of the disease.

In particular, where BSE is suspected in a species other than bovine animals,

samples shall be submitted for strain-typing, where possible.

4. Rapid tests

For the purposes of carrying out the rapid tests in accordance with regulation 5(3)

and regulation 6(1), the following methods shall be used as rapid tests -

-

immuno-blotting test based on a Western blotting procedure for the

detection of the protease-resistant fragment PrPRes (Prionics-Check

Western test),

-

chemiluminescent ELISA test involving an extraction procedure and an

ELISA technique, using an enhanced chemiluminescent reagent (Enfer

test),

-

sandwich immunoassay for PrPRes carried out following denaturation

and concentration steps (Bio-Rad TeSeE test, the former Bio-Rad

Platelia test). However, existing stocks bearing the name 'Bio-Rad

Platelia test' may be used within nine months from the date of entry into

force of these Regulations,

-

microplate based immunoassay (ELISA) which detects protease-

resistant PrPRes with monoclonal antibodies (Prionics-Check LIA test),

-

automated conformation-dependent immunoassay comparing the

reactivity of a detection antibody to the protease-sensitive and protease-

resistant forms of PrPSc (some fraction of the protease-resistant PrPSc

is equivalent to PrPRes) and to PrPC (InPro CDI-5 test).

The producer of the rapid tests must have a quality assurance system in place

agreed by the European Community reference laboratory, which ensures that the test

performance does not change. The producer must provide the test protocol to the

European Community reference laboratory.

Modifications to the rapid test or to the test protocol may only be made following

advance notification to the European Community reference laboratory and provided

that the European Community reference laboratory finds that the modification does

not reduce the sensitivity, specificity or reliability of the rapid test. That finding

shall be communicated to the European Commission and to the national reference

laboratories.

5. Alternative tests.

Without prejudice to European Union Council Directive

82/894/EEC, the territory of Malta shall ensure that any animal

suspected of being infected by a TSE is notified immediately to the

Veterinary Services. Member States shall regularly inform each

other and the European Commission of the cases of TSE notified.

The Veterinary Services shall without delay take the measures laid

down in regulation 12, together with any other necessary measures.

TRANSITIONAL MEASURES REFERRED TO IN REGULATIONS 22 AND 23

Concerning specified risk material, mechanically recovered meat and

slaughtering techniques

1. (a) The following tissues are designated as specified risk material -

(i)

the skull excluding the mandible and including the brain and eyes,

the vertebral column excluding the vertebrae of the tail, the

transverse processes of the lumbar and thoracic vertebrae and the

wings of the sacrum, but including dorsal root ganglia, and the

spinal cord of bovine animals aged over 12 months, and the

tonsils, the intestines from the duodenum to the rectum and the

mesentery of bovine animals of all ages;

(ii) the skull including the brain and eyes, the tonsils and the spinal

cord of ovine and caprine animals aged over 12 months or which

have a permanent incisor erupted through the gum, and the spleen

and ileum of ovine and caprine animals of all ages.

The age set forth above for the removal of bovine vertebral column may

be adjusted by amending these regulations in the light of the statistical

probability of the occurrence of BSE in the relevant age groups of the

European Community’s bovine population, based on the results of BSE

monitoring as established by Chapter A.I of Schedule III.

(b) In addition to the specified risk material listed in (a), the following

tissues must be designated as specified risk material in the United

Kingdom of Great Britain and Northern Ireland and in Portugal, with

the exception of the Autonomous Region of the Azores -

-

the entire head excluding the tongue, including the brain, eyes and

trigeminal ganglia;

-

the thymus,

-

the spleen and the spinal cord

of bovine animals aged over 6 months.

2. By way of derogation from point 1(a)(i), a decision may be taken in

accordance with the Veterinary Services Act and the procedure referred to in

regulation 24(2) to allow the use of vertebral column and dorsal root ganglia from

bovine animals -

(a) born, continuously reared and slaughtered in Member States for which a

scientific evaluation established that the occurrence of BSE in native

bovine animals is highly unlikely, or unlikely but not excluded; or

(b) born after the date of effective enforcement of the prohibition on the

feeding of mammalian protein to ruminants in Member States with

reported BSE in native animals or for which a scientific evaluation

established that the occurrence of BSE in native bovine animals is

likely.

The United Kingdom, Portugal, and Sweden may benefit from this derogation on

the basis of previously submitted and evaluated evidence. Other Member States may

apply for this derogation by submitting conclusive supporting evidence to the

European Commission regarding point (a) or (b), as appropriate.

Mem be r Stat es b en efi ti ng from th is dero gat io n shal l, in a dd it io n to t he

requirements laid down in Schedule III, Chapter A, section I, ensure that one of the

approved rapid tests listed in Schedule X, Chapter C, point 4, is applied to all bovine

animals over 30 months of age which -

(i)

have died on the farm or in transport, but which have not been

slaughtered for human consumption, with the exception of those dead

animals in remote areas with a low animal density situated in Member

States where the occurrence of BSE is unlikely;

(ii) were subject to normal slaughter for human consumption.

This derogation shall not be granted to allow the use of vertebral column and

dorsal root ganglia from bovine animals aged over 30 months from the United

Kingdom or from Portugal with the exception of the Autonomous Region of the

Experts from the European Commission may carry out on-the-spot checks to

further verify the submitted evidence in accordance with regulation 21.

3. Bones of bovine, ovine and caprine animals shall not be used for the

production of mechanically recovered meat.

4. Laceration of central nervous tissue by means of an elongated rod-shaped

instrument introduced into the cranial cavity after stunning shall not be carried out

on bovine, ovine or caprine animals whose meat is intended for human or animal

consumption.

5. 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 Regulation (EC)

No 1774/2002 of the European Parliament and of the Council, article 10

or users and collection centres authorised and registered pursuant to

Regulation (EC) No 1774/2002, article 23(2)(c)(iv), (vi) and (vii).

The above provisions shall not apply to category 1 material for feeding of

necrophagous birds in accordance with article 23(2)(d) of Regulation (EC) No 1774/

2002.

6. 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.

7. 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 head meat with

central nervous system tissue. The system shall include at least the following

provisions -

harvesting shall take place in a dedicated area, physically separated

from the other parts of the slaughterline,

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,

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,

-

head meat shall not be harvested from heads which have not been

properly sealed in accordance with the second indent,

-

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,

-

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. By way of derogation from the requirements of point 7, 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.

9. The provisions of points 7 and 8 shall not apply to the harvesting of the

tongue in accordance with point 6 nor to the harvesting of cheek meat in the

slaughterhouse if performed without removing the bovine head from the conveyor or

hooks.

10. By way of derogation from point 5 and 7, Member States may decide to

allow -

(a) removal of spinal cord of ovine and caprine animals in cutting plants

specifically authorised for this purpose;

(b) removal of vertebral column from carcasses or parts of carcasses in

butcher shops specifically authorised, monitored and registered for this

purpose;

(c) harvesting of head meat from bovine animals in cutting plants

specifically authorised for this purpose in accordance with the

following provisions -

bovine heads intended for transport to cutting plants specifically

authorised for the harvesting of head meat, shall comply with the

following provisions -

- the heads shall be suspended on a rack during the storing

period and the transport from the slaughterhouse to the

specifically authorised cutting plant,

- 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,

- the heads which have not been properly sealed in accordance

with the second indent, 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,

- a sampling plan 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

contamination;

the harvesting of head meat from bovine heads in cutting plants

specifically authorised for this purpose shall be in accordance

with a control system, recognised by the competent authority, to

ensure the prevention of possible contamination of head meat.

The system shall include at least -

- all heads shall be visually controlled for signs of

contamination or damage and proper sealing before the

commencement of the harvesting of the head meat,

- 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,

- 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,

- 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.

11. All specified risk material shall be stained with a dye or, as appropriate,

marked immediately on removal, and disposed of in accordance with the provisions

laid down in Regulation (EC) No 1774/2002, and in particular article 4(2).

12. Member States shall carry out frequent official inspections to verify the

correct application of this part 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

Member States shall in particular set up a system to ensure and check that -

(a) specified risk material used for purposes authorised pursuant to

regulation 1(3) and to European Union Regulation (EC) No 1774/2002

are used solely for authorised purposes;

(b) specified risk material is disposed of in accordance with European

Union Regulation (EC) No 1774/2002.

13. Member States may decide to allow dispatch of heads or carcasses

containing specified risk material to another Member State after that other Member

State has agreed to receive the material and has approved the specific conditions

applicable to such transport.

However, carcasses, half carcasses or half carcasses cut into no more than three

wholesale cuts, and quarters containing no specified risk material other than

vertebral column, including dorsal root ganglia, may be imported into a Member

State, or dispatched to another Member State without the latter’s prior agreement.

14. A control system shall be put in place for the removal of the vertebral

column as specified in point 1(a)(i). The system shall include at least the following

(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 blue stripe on the label referred to in

European Union Regulation (EC) No 1760/2000;

(b) a specific indication of 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 commercial document referred to in

article 3(1)(A)(f)(ii) of European Union Council Directive 64/433/EEC

or to the document referred to in article 1(2) of European Union

Commission Decision 93/13/EEC, as applicable;

(c) butcher shops shall keep, for at least one year, the commercial

documents referred to in (b).

15. (a) The products of animal origin listed below shall be subject to the

conditions laid down in (b) on import into the European Community -

the specified risk material referred to in point 1(a),

fresh meat - the meat defined by European Union Council

Directive 64/433/EEC,

minced meat and meat preparations: the minced meat and meat

preparations defined by European Union Council Directive 94/65/

EC,

meat products: the meat products defined by European Union

Council Directive 77/99/EEC,

other products of animal origin: other products of animal origin as

defined by European Union Council Directive 77/99/EEC,

rendered fats as referred to in European Union Regulation (EC)

No 1774/2002,

gelatine as referred to by European Union Council Directive 92/

118/EEC and European Union Regulation (EC) No 1774/2002,

pet food as referred to in European Union Regulation (EC) No

1774/2002,

blood products as referred to in European Union Regulation (EC)

No 1774/2002,

the processed animal protein referred to in European Union

Regulation (EC) No 1774/2002,

bones and bone products as referred to in European Union

Regulation (EC) No 1774/2002,

category 3 material as referred to in European Union Regulation

(EC) No 1774/2002.

Any reference to "products of animal origin" designates products of

animal origin listed in this point and does not concern other products of

animal origin containing or derived from those products of animal

origin.

(b) When the abovementioned products of animal origin, containing

material from bovine, ovine or caprine animals are imported into the

European Community from third countries or regions thereof, the health

certificates shall be accompanied by a declaration signed by the

competent authority of the country of production, worded as follows -

"This product does not contain and is not derived from -

either

specified risk material as defined in Annex XI, section A, to European

Union Regulation (EC) No 999/2001 produced or mechanically

recovered meat obtained from bones of bovine, ovine or caprine

animals. The bovine, ovine and caprine animals, from which this

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 after stunning of central nervous tissue by

means of an elongated rod-shaped instrument introduced into the cranial

cavity.

Carcasses, half carcasses and quarter carcasses may contain vertebral

column on import;

Or

Bovine, ovine and caprine materials other than those derived from

animals born, continuously reared and slaughtered in the following

countries -

- Argentina

- Australia

- Botswana

- Brazil

- Chile

- El Salvador

- Iceland

- Namibia

- Territoire français de la Nouvelle Calédonie

- New Zealand

- Nicaragua

- Panama

- Paraguay

- Singapore

- Switzerland

- Uruguay

- Vanuatu".

Concerning statistical surveys

(deleted by (EC) No. 1494/2002)

Concerning prohibitions on animal feeding

(deleted by (EC) No. 1234/2003)

D.

Concerning placing on the market and export

1. The following provisions remain in force as transitional measures -

European Union Council Decision 98/256/EC of 16 March 1998 concerning

emergency measures to protect against bovine spongiform encephalopathy,

amending Decision 94/474/EC and repealing Decision 96/239/EC.

European Union Commission Decision 98/351/EC of 29 May 1998 setting the date

on which dispatch from Northern Ireland of bovine products under the Export

Certified Herds Scheme may commence by virtue of article 6(5) of European Union

Council Decision 98/256/EC.

European Union Commission Decision 1999/514/EC of 23 July 1999 setting the

date on which dispatch from the United Kingdom of bovine products under the date-

based export scheme may commence by virtue of article 6(5) of Council Decision

98/256/EC.

European Union Commission Decision 2000/345/EC of 22 May 2000 setting the

date on which dispatch from Portugal to Germany of certain products for the purpose

of incineration may commence by virtue of article 3(6) of European Union Decision

98/653/EC.

European Union Commission Decision 2000/371/EC of 6 June 2000 setting the

date on which dispatch of fighting bulls from Portugal to France may commence by

virtue of article 3(7) of European Union Decision 98/653/EC.

European Union Commission Decision 2000/372/EC of 6 June 2000 setting the

date on which dispatch of fighting bulls from Portugal to Spain may commence by

virtue of article 3(7) of European Union Decision 98/653/EC.

European Union Commission Decision 2001/376/EC of 18 April 2001 concerning

measures made necessary by the occurrence of bovine spongiform encephalopathy in

Portugal and implementing a date-based export scheme.

2. Imports of bovine animals are to be subject to the presentation of an

international animal health certificate attesting that -

(a) the feeding of ruminants with proteins derived from mammals has been

banned and the ban has been effectively enforced;

(b) the bovine animals intended for export to the European Community are

identified by a permanent identification system enabling them to be

traced back to the dam and herd of origin and are not the progeny of

BSE suspected females.

3. Point 2 shall not apply to imports of bovine animals born and continuously

reared in the following countries -

- Argentina

- Australia

- Botswana

- Brazil

- Chile

- El Salvador

- Iceland

- Namibia

- Territoire français de la Nouvelle Calédonie

- New Zealand

- Nicaragua

- Panama

- Paraguay

- Singapore

- Switzerland

- Uruguay

- Vanuatu.

(1) Any animal suspected of being infected by a TSE shall

be placed under an official movement restriction until the results of

a clinical and epidemiological examination carried out by the

competent authority are known, or killed for laboratory

examination under official control. If BSE is suspected in a bovine

animal at a holding in the territory of Malta, all other bovine

animals from that holding shall be placed under an official

movement restriction until the results of the examination are

available.

If BSE is suspected in an ovine or caprine animal at a

holding in the territory of Malta on the basis of objective evidence

such as the results of tests capable of differentiating in a practical

way between the various TSEs, all other ovine and caprine animals

from that holding shall be placed under an official movement

restriction until the results of the examination are available.

If there is evidence that the holding where the animal was

present when BSE was suspected is not likely to be the holding

where the animal could have been exposed to BSE, the Veterinary

Services may decide that only the animal suspected of being

infected shall be placed under an official movement restriction. If

considered necessary, the Veterinary Services may also decide that

other holdings or only the holding of exposure shall be placed

under official control depending on the epidemiological

information available.

Under the procedure referred to in regulation 24(2) and by

way of derogation from the requirements of the second, third and

fourth paragraphs of this subregulation, a Member State may be

exempted from the application of official restrictions on the

movement of animals if it applies measures offering equivalent

safeguards.

(2) Where the Veterinary Services decides that the possibility

of infection with a TSE cannot be ruled out, the animal shall be

killed, if it is still alive; its brain and all other tissues as the

Veterinary Services may determine shall be removed and sent to an

officially approved laboratory, the national reference laboratory

provided for in regulation 19(1) or the European Community

reference laboratory provided for in regulation 19(2), for

examination in accordance with the testing methods laid down in

regulation 20.

(3) All parts of the body of the suspect animal including the

hide shall be retained under official control until a negative

diagnosis has been made or shall be destroyed in accordance with

Schedule V, point 3 or 4.

(4) Rules for the implementation of this regulation shall be

adopted in accordance with the procedure referred to in regulation

24(2) and in accordance with article 4 of the Veterinary Services

Act.

(1) When the presence of a TSE has been officially

confirmed, the following measures shall be applied as soon as

possible

(a) all parts of the body of the animal shall be completely

destroyed in accordance with Schedule V apart from

material retained for records in accordance with

Schedule III, Chapter B, III, 2;

(b) an inquiry shall be carried out to identify all animals at

risk in accordance with Schedule VII, point 1;

(c) all animals and products of animal origin referred to in

Schedule VII, point 2, that have been identified as

being at risk by the inquiry referred to in paragraph

(b), shall be killed and completely destroyed in

accordance with Schedule V, points 3 and 4.

By way of derogation from this subregulation, the territory

of Malta may apply other measures offering an equivalent level of

protection if those measures have been approved in accordance

with the procedure referred to in regulation 24(2).

(2) Pending the implementation of the measures referred to in

subregulation (1)(b) and (c), the holding on which the animal was

present when the presence of a TSE was confirmed shall be placed

under official control and all movement of animals susceptible to

TSEs and products of animal origin derived from them from or to

the holding shall be subject to authorisation by the Veterinary

Services, with a view to ensuring immediate tracing and

identification of the animals and products of animal origin

concerned.

If there is evidence that the holding where the affected

animal was present when the TSE was confirmed is not likely to be

t he ho ld in g w h e re t he a ni m a l w a s e xp os e d t o th e T S E , t he

Veterinary Services may decide that both holdings or only the

holding of exposure shall be placed under official control.

(3) In the case where the territory of Malta would decide to

implement a substitute scheme offering equivalent safeguards

provided for in the fifth paragraph of regulation 12(1) may, by way

of derogation from the requirements of subregulation (1)(b) and

(c), be exempted in accordance with the procedure referred to in

regulation 24(2) from the requirement to apply official restrictions

on the movement of animals and from the requirement to kill and

destroy animals.

(4) Owners shall be compensated without delay for the loss of

the animals that have been killed or products of animal origin

destroyed in accordance with subregulation (1)(a) and (c) and in

accordance with regulation 12(2).

(5)

Without prejudice to European Union Council Directive 82/

894/EEC, the confirmed presence of any TSE other than BSE shall

be notified to the European Commission on an annual basis.

(6) Rules for the implementation of this regulation shall be

adopted in accordance with the procedure referred to in regulation

24(2). Moreover the provisions of article 4 of the Veterinary

Services Act shall apply.

(1) The territory of Malta following the rules found under

article 4 of the Veterinary Services Act and in accordance with the

general criteria of European Community rules on the control of

animal diseases shall draw up guidelines specifying the national

measures to be implemented and indicating competences and

responsibilities where cases of TSE are confirmed.

(2) Where necessary to enable European Community

le g is la ti o n t o be a p pl i e d u ni f o r m l y, t h e g ui d e l i n e s m a y b e

harmonised in accordance with the procedure referred to in

regulation 24(2).

CHAPTER V

PLACING ON THE MARKET AND EXPORT

(1) Placing on the market or, if need be, export of bovine,

ovine or caprine animals and their semen, embryos and ova shall be

subject to the conditions laid down in Schedule VIII, or, in the case

of imports, to the conditions laid down in Schedule IX. The live

animals and their embryos and ova shall be accompanied by the

appropriate animal health certificates as required by European

Community legislation, in accordance with regulation 17 or, in the

case of imports, regulation 18.

(2) The placing on the market of first generation progeny,

semen, embryos and ova of TSE suspect or confirmed animals shall

be subject to the conditions laid down in Schedule VIII, Chapter B.

(3) Rules for the implementation of this regulation shall be

adopted in accordance with the procedure referred to in regulation

24(2) and in accordance with article 7 of the Veterinary Services

Act.

(1) The following products of animal origin derived from

healthy ruminants shall not be subject to restrictions on placing on

the market or, if need be, export pursuant to this regulation, to

Schedule VIII, Chapters C and D, and to Schedule IX, Chapters A,

C, F and G

(a) products of animal origin covered by regulation 15, in

particular semen, embryos and ova;

(b)

(i)

raw milk within the meaning of European Union

Council Directive 92/46/EEC;

(ii) milk for the manufacture of milk-based products

within the meaning of European Union Council

Directive 92/46/EEC;

(iii) heat-treated drinking milk within the meaning of

European Union Council Directive 92/46/EEC;

(iv)

dicalcium phosphate (without any trace of

protein or fat);

(v)

hides and skins within the meaning of European

Union Council Directive 92/118/EEC;

(vi)

gelatine within the meaning of European Union

Council Directive 92/118/EEC, derived from the

hides and skins referred to in sub-paragraph (v);

(vii)

collagen derived from the hides and skins

referred to in sub-paragraph (v).

(2) Products of animal origin imported from a third country

placed in categories 2, 3, 4 and 5 must come from healthy bovine,

ovine and caprine animals which have not been subjected to a

laceration of the central nervous tissue as referred to in regulation

8(3) or killed by means of a gas injected into the cranial cavity.

(3) Products of animal origin containing materials obtained

from bovine animals originating in a Member State, a region of a

Member State or a third country classified in category 5 shall not

be placed on the market unless they come from -

(a) animals born after the date from which the prohibition

on the feeding to ruminants of animal protein derived

from mammals was effectively enforced; or

(b) animals which were born, raised and have stayed in

herds with a certified history of freedom from BSE for

at least seven years.

Furthermore, products of animal origin shall not be

despatched from a Member State or a region of a Member State

classified in category 5 to another Member State or be imported

from a third country classified in category 5. That prohibition shall

not apply to products of animal origin listed in Schedule VIII,

Chapter C, and fulfilling the requirements of Schedule VIII,

Chapter C. They must be accompanied by an animal health

certificate issued by an official veterinarian certifying that they

have been produced in conformity with these regulations.

(4) When an animal is moved from a country or a region to

country or region included in another category, it shall be classified

in the highest category of the countries or regions in which it has

stayed over twenty four hours unless adequate guarantees can be

provided certifying that the animal has not received feedingstuffs

from the country or region classified in the highest category.

(5) Products of animal origin for which this regulation lays

down specific rules shall be accompanied by the appropriate animal

health certificates or commercial documents as required by

European Community legislation in accordance with regulations 17

and 18 or, if such certificates or documents are not provided for in

European Community legislation, by a health certificate or

commercial document the specimens of which shall be established

in accordance with the procedure referred to in regulation 24(2)

and according to article 10 of the Veterinary Services Act.

(6)

For the purpose of import into the European Community,

products of animal origin shall comply with the conditions laid

down in Schedule IX, Chapters A, C, F and G.

(7) In accordance with article 10 and 12 of the Veterinary

Services Act and the procedure referred to in regulation 24 (2), the

provisions of subregulations (1) to (6) may be extended to other

products of animal origin. Rules for the implementation of this

regulation shall be adopted by the same procedure.

In accordance with article 7 of the Veterinary Services Act

and under the procedure referred to in regulation 24(2), the health

certificates referred to in Annex F to European Union Council

Directive 64/432/EEC, Models II and III in Annex E to European

Union Council Directive 91/68/EEC and the appropriate health

certificates laid down by European Community legislation relating

to trade in the semen, embryos and ova of bovine, ovine or caprine

animals shall be supplemented, where necessary, by a reference to

the category specifying the classification of the Member State or

region of origin given in accordance with regulation 5.

Appropriate commercial documents relating to trade in

products of animal origin shall be supplemented, where necessary,

by a reference to the category of the Member State or region of

origin given by the European Commission in accordance with

regulation 5.

The appropriate health certificates relating to imports

p r o v i d e d f o r b y E u r o p e a n C o m m un i t y l e g i s l a t i o n s h a l l , i n

accordance with article 8 and article 12(2)(c) of the Veterinary

Services Act and under the procedure referred to in regulation

24(2), be supplemented in respect of third countries classified in a

category pursuant to regulation 5 by the specific requirements laid

down in Schedule IX, as soon as that classification decision has

been taken.

CHAPTER VI

REFERENCE LABORATORIES, SAMPLING, TESTING

AND CONTROLS

(1) The national reference laboratories in each Member

State and their functions and duties shall be those indicated in

Schedule X, Chapter A.

(2) The European Community reference laboratory and its

functions and duties shall be those laid down in Schedule X,

Chapter B.

(1) Sampling and laboratory testing for the presence of a

TSE shall be carried out using the methods and protocols laid down

in Schedule X, Chapter C.

(2) Where necessary to ensure the uniform application of this

regulation, implementing rules, including the method to confirm

BSE in ovine and caprine animals, shall be adopted in accordance

with the rules provided under the Veterinary Services Act and the

procedure referred to in regulation 24(2).

(1) Experts from the European Commission may make on-

the-spot checks in co-operation with the Veterinary Services of the

t er r i t o r y o f M a l t a , i n so f a r as i s n e c e ss a r y f o r t h e u n i f o r m

application of these regulations. The Veterinary Services shall

provide the experts with all the assistance necessary for carrying

out their duties. The European Commission shall inform the

Veterinary Services of the results of the checks made.

The rules for the application of this regulation, and in

particular those governing the procedure for co-operation with the

national authorities, shall be adopted in accordance with the

procedure referred to in regulation 24(2).

(2) European Community checks concerning third countries

shall be made in accordance with articles 20 and 21 of European

Union Council Directive 97/78/EC.

CHAPTER VII

TRANSITIONAL AND FINAL PROVISIONS

(1) The provisions of Schedule XI, Part A shall cease to

apply immediately following the date of adoption of a decision in

accordance with regulation 5(2) or (4), on which date regulation 8

shall enter into force.

(2) The results of a conclusive statistical survey carried out in

accordance with regulation 5(3) during the transitional period shall

be used to confirm or overturn the risk analysis conclusions

r e f e r r e d t o i n r e gu l a t i o n 5 ( 1 ) , w h i l e t a ki n g a c c o u n t o f th e

classification criteria defined by the OIE.

(3) After consultation of the appropriate scientific committee,

detailed rules concerning that statistical survey shall be adopted in

accordance with the procedure referred to in regulation 24(2).

(4) The minimum criteria to be met by this statistical survey

shall be those laid down in Part B of Schedule XI.

After consultation of the appropriate scientific committee

on any question which could have an impact on public health, the

Schedules shall be amended or supplemented and any appropriate

transitional measures shall be adopted in accordance with the rules

found under the Veterinary Services Act and the procedure referred

to in regulation 24(2).

(1) The European Commission shall be assisted by the

Standing Veterinary Committee. However, for matters exclusively

concerning animal feedingstuffs, the European Commission shall

be assisted by the Standing Committee on Feedingstuffs and, for

matters exclusively concerning foodstuffs, by the Standing

Committee on Foodstuffs.

(2) Where reference is made to this subregulation, regulations

5 and 7 of European Union Decision 1999/468/EC shall apply, in

compliance with regulation 8 thereof.

The period referred to in article 5(6) of that Decision shall

be three months and, in the case of safeguard measures referred to

in regulation 4(2) of these regulations, fifteen days.

(3)

Each Committee shall adopt its rules of procedure.

The appropriate scientific committees shall be consulted on

any matter within the scope of these regulations which could have

an impact on public health.