2001R0999 — EN — 01.10.2003 — 008.002 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B REGULATION (EC) No 999/2001 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL
of22May2001
layingdownrulesfortheprevention,controlanderadication ofcertain transmissiblespongiform
encephalopathies
(OJ L 147, 31.5.2001, p. 1)
Amended by:
Official Journal
No page date
►M1Commission Regulation (EC) No 1248/2001 of 22 June 2001 L 173 12 27.6.2001
►M2Commission Regulation (EC) No 1326/2001 of 29 June 2001 L 177 60 30.6.2001
►M3Commission Regulation (EC) No 270/2002 of 14 February 2002 L 45 4 15.2.2002
►M4Commission Regulation (EC) No 1494/2002 of 21 August 2002 L 225 3 22.8.2002
►M5Commission Regulation (EC) No 260/2003 of 12 February 2003 L 37 7 13.2.2003
►M6Commission Regulation (EC) No 650/2003 of 10 April 2003 L 95 15 11.4.2003
►M7Commission Regulation (EC) No 1053/2003 of 19 June 2003 L 152 8 20.6.2003
►M8Regulation (EC) No 1128/2003 of the European Parliament and of the
Council of 16 June 2003L 160 1 28.6.2003
►M9Commission Regulation (EC) No 1139/2003 of 27 June 2003 L 160 22 28.6.2003
►M10Commission Regulation (EC) No 1234/2003 of 10 July 2003 L 173 6 11.7.2003
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REGULATION(EC)No999/2001OFTHEEUROPEANPARLIA-
MENTANDOFTHECOUNCIL
of22May2001
laying down rules for the prevention, control and eradication of
certain transmissiblespongiformencephalopathies
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and
in particular Article 152(4)(b) thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the Economic and Social
Committee (2),
Having consulted the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of
the Treaty (3),
Whereas:
(1)Several distinct transmissible spongiform encephalopathies
(TSEs) have for a number of years been recognised as occurringseparately in humans and animals. Bovine spongiform encepha-
lopathy (BSE) was first recognised in bovine animals in 1986
and in the following years was recognised as occurring in otherspecies of animal. A new variant of Creutzfeldt-Jakob Disease(CJD) was described in 1996. Evidence continues to grow ofthe similarity between the BSE agent and that of the new variantof Creutzfeld-Jakob Disease.
(2)Since 1990 the Community has adopted a series of measures toprotect human and animal health from the risk of BSE. Those
measures have been based on the safeguard provisions of Direc-
tives on animal-health measures. It is appropriate, in view of themagnitude of the risk posed to human and animal health bycertain TSEs, to adopt specific rules for their prevention, controland eradication.
(3)This Regulation directly concerns public health and is relevant tothe functioning of the internal market. It covers products whichare included in Annex I to the Treaty as well as products which
are not. Consequently, it is appropriate to choose Article
152(4)(b) of the Treaty as the legal basis.
(4)The Commission has obtained scientific opinions, in particularfrom the Scientific Steering Committee and the ScientificCommittee on Veterinary Measures relating to Public Health,on several aspects of TSEs. Those opinions include advice onmeasures to reduce the potential risk for humans and animals
resulting from exposure to infected animal products.
(5)These rules should apply to the production and placing on themarket of live animals and products of animal origin. However,
it is not necessary for them to apply to cosmetic or medicinalproducts, medical devices or their starting materials or inter-mediate products, for which other specific rules, in particularon the non-use of specified risk material, apply. Nor shouldthey apply to products of animal origin which do not pose a
risk to animal or human health since they are intended for
purposes other than the production of food, feed or fertiliser. Itis appropriate to ensure that products of animal origin excluded2001R0999 — EN — 01.10.2003 — 008.002 — 2
(1) OJ C 45, 19.2.1999, p. 2 and
OJ C 120 E, 24.4.2001, p. 89.
(2) OJ C 258, 10.9.1999, p. 19.
(3) Opinion of the European Parliament of 17 May 2000 (OJ C 59, 23.2.2001,
p. 93), Common Position of the Council of 12 February 2001 (OJ C 88,
19.3.2001, p. 1) and Decision of the European Parliament of 3 May 2001.
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from the scope of this Regulation are kept separate from those
covered by it unless they meet at least the same health standardsas the latter.
(6)Provision should be made for safeguard measures to be taken bythe Commission in cases where a risk from a TSE has not been
adequately addressed by the competent authority of a Member
State or third country.
(7)A procedure should be established for the determination of the
epidemiological status of a Member State, a third country and
of one of their regions, hereinafter referred to as ‘countries orregions’ with respect to BSE, on the basis of the incident propa-gation and human exposure risk, using information available.Member States and third countries which choose not to applyfor their status to be determined should be classified in a cate-
gory by the Commission on the basis of all the information
available to it.
(8)Member States should institute education programmes for those
involved in the prevention and control of TSEs, as well as for
veterinarians, farmers and workers involved in the transportation,marketing and slaughter of farm animals.
(9)Member States should carry out an annual programme for moni-toring BSE and scrapie and should inform the Commission andthe other Member States of the results and of the emergence ofany other TSE.
(10)Certain ruminant tissues should be designated as specified riskmaterial on the basis of the pathogenesis of TSEs and the epide-miological status of the country or region of origin or residenceof the animal concerned. The specified risk material should be
removed and disposed of in a manner which avoids any risk to
human or animal health. In particular, it should not be placed onthe market to be used in the production of food, feed or ferti-liser. However, provision should be made for an equivalentlevel of health protection by means of a screening test for TSEscarried out on individual animals as soon as it has been fully
validated. Slaughter techniques presenting a risk of causing brain
material to contaminate other tissues should not be permitted incountries or regions other than those presenting the lowest riskof BSE.
(11)Measures should be taken to prevent the transmission of TSEs tohumans or animals by prohibiting the feeding of certain cate-gories of animal protein to certain categories of animal, and byprohibiting the use of certain ruminant materials in food. Thoseprohibitions should be proportionate to the risks involved.
(12)The suspected presence of any TSE in any animal should benotified to the competent authority, which should immediatelytake all appropriate measures, including placing the suspect
animal under movement restrictions while awaiting the results
of the investigation or having it slaughtered under official super-vision. If the competent authority cannot exclude the possibilityof a TSE, it should have the appropriate investigations carriedout and should keepthe carcasse under official sup ervision until
a diagnosis has been made.
(13)In the event of official confirmation of the presence of a TSE,
the competent authority should take all the necessary measures,
including having the carcasse destroyed, carrying out an investi-
gation in order to identify all animals at risk and placingmovement restrictions on the animals and the products of animalorigin identified as such. Owners should be compensated, assoon as possible, for the loss of animals and products of animalorigin destroyed pursuant to this Regulation.2001R0999 — EN — 01.10.2003 — 008.002 — 3
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(14)Member States should draw upcontingency p lans for the
national measures to be implemented in the event of an outbreak
of BSE. Those plans should be approved by the Commission.Provision should be made for extending this provision to TSEsother than BSE.
(15)Provisions should be laid down covering the placing on themarket of certain live animals and products of animal origin.Existing Community rules on the identification and registrationof bovine animals provide for a system enabling the animals to
be traced back to the dam and herd of origin in accordance with
international standards. Equivalent guarantees should beprovided for bovine animals imported from third countries. Theanimals and products of animal origin covered by Communityrules, moving in intra-Community trade or imported from thirdcountries, should be accompanied by the certificates required by
the said rules, supplemented as appropriate in accordance with
this Regulation.
(16)The placing on the market of certain products of animal originderived from bovine animals in high risk regions should beprohibited. However, that prohibition should not apply to certainproducts of animal origin produced under controlled conditionsfrom animals which can be demonstrated not to pose a highrisk of infection with a TSE.
(17)It is necessary, in order to ensure that the rules concerning theprevention, control and eradication of TSEs are observed, for
samples to be taken for laboratory testing on the basis of an
established protocol which would give a full epidemiologicalpicture of the situation as regards TSE. In order to guaranteeuniform testing procedures and results, national and CommunityReference Laboratories and reliable scientific methods, includingrapid tests specifically for TSEs, should be established. Rapid
tests should be used as far as possible.
(18)Community inspections should be carried out in the MemberStates in order to ensure uniform implementation of the require-
ments concerning the prevention, control and eradication ofTSEs and provision should also be made for the implementationof audit procedures. In order to ensure that guarantees equivalentto those applied by the Community are provided by third coun-
tries upon import into the Community of live animals and
products of animal origin, Community on-the-spot inspectionsand audits should be carried out in order to verify that the importconditions are met by exporting third countries.
(19)Trade measures for TSEs should be based on international stan-dards, guidelines or recommendations, where they exist.However, scientifically justified measures resulting in a higherlevel of health protection may be adopted if measures based on
the relevant international standards, guidelines or recommenda-
tions would not achieve the appropriate level of healthprotection.
(20)This Regulation should be re-examined as new scientific infor-mation becomes available.
(21)The necessary transitional measures in particular for regulatingthe use of specified risk material should be provided for in theframework of this Regulation.
(22)The measures necessary for the implementation of this Regula-tion should be adopted in accordance with Council Decision1999/468/EC of 28 June 1999 laying down the procedure forthe exercise of implementing powers conferred on the Commis-sion(
1).2001R0999 — EN — 01.10.2003 — 008.002 — 4
(1) OJ L 184, 17.7.1999, p. 23.
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(23)In order to implement this Regulation, procedures should be laid
down establishing close and effective cooperation between the
Commission and the Member States within the Standing Veter-inary Committee, the Standing Committee on Feedingstuffs, andthe Standing Committee on Foodstuffs.
(24)Given that the provisions for the implementation of this Regula-tion are general measures within the meaning of Article 2 ofDecision 1999/468/EC, they should be adopted in accordance
with the regulatory procedure laid down in Article 5 of that
Decision,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
GENERALPROVISIONS
Article 1
Scope
1. This Regulation lays down rules for the prevention, control and
eradication of transmissible spongiform encephalopathies (TSEs) inanimals. It shall apply to the production and placing on the market oflive animals and products of animal origin and in certain specific casesto exports thereof.
2. This Regulation 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, scien-
tific research, special studies or analysis, provided those productsare not eventually consumed or used by humans or by animalsother than those kept for the research projects concerned;
(d) live animals used in or intended for research.
Article 2
Separationoflive animalsandofproductsofanimalorigin
In order to avoid cross-contamination or substitution between the live
animals or of the products of animal origin referred to in Article 1(1)and the products of animal origin referred to in Article 1(2)(a), (b) and
(c), or the live animals referred to in Article 1(2)(d), they shall be kept
separate at all times unless such live animals or products of animalorigin are produced under at least the same conditions of health protec-tion in respect of TSEs.
Rules for the implementation of this Article shall be adopted in accor-
dance with the procedure referred to in Article 24(2).
Article 3
Definitions
1. For the purposes of this Regulation the following definitions shall
apply:
(a) TSEs: all transmissible spongiform encephalopathies with the
exception of those occurring in humans;
(b) placing on the market: any operation the purpose of which is to
sell live animals or products of animal origin covered by thisRegulation to a third party in the Community, or any other formof supply against payment or free of charge to such a third partyor storage with a view to supply to such a third party;2001R0999 — EN — 01.10.2003 — 008.002 — 5
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(c) products of animal origin: any product derived from or containing
a product derived from any animal covered by the provisions ofDirective 89/662/EEC (
1) or Directive 90/425/EEC (2);
(d) starting materials: raw materials or any other product of animal
origin out of which, or with the helpof which, the p roductsreferred to in Article 1(2)(a) and (b) are produced;
(e) competent authority: the central authority of a Member State
competent to ensure compliance with the requirements of thisRegulation or any authority to which that central authority has
delegated that competence, in particular for the control of feeding-
stuffs; it shall also include, where appropriate, the correspondingauthority of a third country;
(f) category: one of the classification categories referred to in Chapter
C of Annex II;
(g) specified risk material: the tissues specified in Annex V; unless
otherwise indicated, it does not include products containing or
derived from those tissues;
(h) animal suspected of being infected by a TSE: live, slaughtered or
dead animals, which show or have shown neurological or beha-vioural disorders or a progressive deterioration of the generalcondition linked to impairment of the central nervous system and
for which the information gathered on the basis of a clinical exam-
ination, response to treatment, a post-mortem examination or anante or post-mortem laboratory analysis do not allow an alternativediagnosis to be established. Bovine spongiform encephalopathies(BSE) shall be suspected in bovine animals which have produceda positive result from a rapid test specifically for BSE;
(i) holding: any place in which animals covered by this Regulation
are held, kept, bred, handled or shown to the public;
(j) sampling: the taking of samples, ensuring a statistically correct
representation, from animals or their environment, or fromproducts of animal origin, for the purpose of establishing a diseasediagnosis, 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) fertilisers: any substance containing products of animal origin
utilised on land to enhance growth of vegetation; it may includedigestion residues from bio-gas production or composting;
(l) rapid tests: the analysis methods referred to in Annex X, Chapter
C, point 4, and for which the results are known within 24 hours;
(m) alternative test: the tests referred to in Article 8(2) which are used
as an alternative to the withdrawal of specified risk material.
2. The specific definitions set out in Annex I shall also apply.
3. Where the terms in this Regulation are not defined in paragraph 1
or Annex I, the relevant definitions given in Regulation (EC) No2001R0999 — EN — 01.10.2003 — 008.002 — 6
(1) Council Directive 89/662/EEC of 11 December 1989 concerning veterinary
checks in intra-Community trade with a view to the completion of the
internal market (OJ L 395, 30.12.1989, p. 13). Directive as last amended
by Council Directive 92/118/EEC (OJ L 62, 15.3.1993, p. 49).
(2) Council Directive 90/425/EEC of 26 June 1990 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
(OJ L 224, 18.8.1990, p. 29). Directive as last amended by Council Direc-
tive 92/118/EEC.
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1760/2000 (1) and those given in or pursuant to Directives 64/432/
EEC (2), 89/662/EEC, 90/425/EEC and 91/68/EEC (3) shall apply
insofar as reference is made to them in this text.
Article 4
Safeguardmeasures
1. With regard to the implementation of safeguard measures, the
principles and provisions set out in Article 9 of Directive 89/662/EEC,Article 10 of Directive 90/425/EEC, Article 18 of Directive 91/496/
EEC (
4) and Article 22 of Directive 97/78/EC (5) shall apply.
2. The safeguard measures shall be adopted in accordance with the
procedure referred to in Article 24(2) and shall be notified at the sametime to the European Parliament, stating the reasons.
CHAPTER II
DETERMINATIONOFBSESTATUS
Article 5
Classification
1. The BSE status of 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 Annex II,Chapter A, and the outcome of a risk analysis on the basis of all thepotential factors for the appearance of bovine spongiform encephalo-pathy as defined in Annex II, Chapter B, and their development over
time.
Member States, and third countries wishing to be retained on the list of
third countries approved for the export to the Community of the liveanimals or of the products covered by this Regulation, shall submit tothe Commission an application for their BSE status to be determined,accompanied by the relevant information on the criteria set out in
Annex II, Chapter A, and on the potential risk factors specified in
Annex II, Chapter B, and their development over time.
2. A decision on each application, placing the Member State or third
country or region of the Member State or third country whichsubmitted the application in one of the categories defined in Annex II,
Chapter C, shall be adopted, taking account of the criteria and potential
risk factors set out in paragraph 1, in accordance with the procedurereferred to in Article 24(2).
This decision shall be taken within six months of the submission of the
application and of the relevant information referred to in the second
subparagraph of paragraph 1. If the Commission finds that the2001R0999 — EN — 01.10.2003 — 008.002 — 7
(1) Regulation (EC) No 1760/2000 of the European Parliament and of the
Council of 17 July 2000 establishing a system for the identification and
registration of bovine animals and regarding the labelling of beef and beef
products and repealing Council Regulation (EC) No 820/97 (OJ L 204,
11.8.2000, p. 1).
(2) Council Directive 64/432/EEC of 26 June 1964 on animal health problems
affecting intra-Community trade in bovine animals and swine (OJ 121
29.7.1964, p. 1977/64). Directive as last amended by Directive 2000/20/EC
of the European Parliament and of the Council (OJ L 163, 4.7.2000, p. 35).
(3) Council Directive 91/68/EEC of 28 January 1991 on animal health condi-
tions governing intra-Community trade in ovine and caprine animals (OJ L
46, 19.2.1991, p. 19). Directive as last amended by Commission Decision
94/953/EC (OJ L 371, 31.12.1994, p. 14).
(4) Council Directive 91/496/EEC of 15 July 1991 laying down the principles
governing the organisation of veterinary checks on animals entering the
Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC (OJ L 268, 24.9.1991, p. 56). Directive as last
amended by Directive 96/43/EC (OJ L 162, 1.7.1996, p. 1).
(
5) Council Directive 97/78/EC of 18 December 1997 laying down the princi-
ples governing the organisation of veterinary checks on products entering
the Community from third countries (OJ L 24, 30.1.1998, p. 9).
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supporting evidence does not include the information laid down in
Annex II, Chapters A and B, it shall ask for additional information tobe provided within a period to be specified. The final decision shall
then be taken within six months of the submission of all information.
After the International Office of Epizootic Diseases (OIE) has estab-
lished a procedure for the classification of countries by category and
if it has placed the applicant country in one of those categories, a re-
assessment of the Community categorisation of the country concernedin accordance with the first subparagraph of this paragraph may bedecided, if appropriate, in accordance with the procedure referred toin Article 24(2).
3. If the Commission finds that the information submitted by a
Member State or a third country pursuant to Annex II, Chapters Aand B, is insufficient or unclear, it may, in accordance with the proce-dure referred to in Article 24(2), determine the BSE status of the
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 Commission shall take into account the classifica-tion criteria used by the OIE.
The rapid tests shall be approved for that purpose in accordance with
the procedure referred to in Article 24(2) and entered on a list set outin Annex 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 thatbasis approved by the Commission — in accordance with the proce-dure laid down in Article 24(2).
The cost of such screening procedure shall be borne by the Member
State or third country concerned.
4. Member States or third countries which have not submitted an
application in accordance with paragraph 1 within six months of 1July 2001 shall, with respect to the dispatch from their territory oflive animals and products of animal origin, be considered as countriesin category 5, referred to in Annex II, Chapter C, until they havesubmitted such an application.
5. Member States shall notify the Commission as soon as possible of
any epidemiological evidence or other information which might lead toa change in BSE status, in particular the results of the monitoring
programmes provided for in Article 6.
6. The retention of a third country on one of the lists provided for
by Community rules for the purpose of being allowed to export to the
Community live animals and products of animal origin for which this
Regulation provides specific rules shall be decided upon under theprocedure laid down in Article 24(2) and shall be made conditional —in the light of the information available or where a TSE is presumed tobe present — on the information provided for in paragraph 1 beingsupplied. In the event of refusal to supply the said information within
three months of the date of the Commission's request, the provisions of
paragraph 4 of this Article shall apply until this information has beensubmitted and evaluated in accordance with paragraphs 2 or 3.
The eligibility of third countries to export to the Community live
animals, or products of animal origin for which this Regulationprovides specific rules, under conditions based on their category asestablished by the Commission, shall be conditional upon their under-taking to notify the latter in writing as soon as possible of anyepidemiological or other evidence which might lead to a change in
BSE status.
7. A decision may be taken, under the procedure laid down in
Article 24(2), to change the BSE classification of a Member State or2001R0999 — EN — 01.10.2003 — 008.002 — 8
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third country, or of one of its regions, in accordance with the results of
the checks provided for in Article 21.
8. The decisions referred to in paragraphs 2, 3, 4, 6 and 7 shall be
based on a risk assessment, taking into consideration the recommendedcriteria set out in Annex II, Chapters A and B.
CHAPTER III
PREVENTIONOFTSE
Article 6
Monitoringsystem
1. Each Member State shall carry out an annual programme for
monitoring BSE and scrapie in accordance with Annex III, Chapter A.
That programme shall include a screening procedure using rapid tests.
Rapid tests shall be approved for that purpose in accordance with the
procedure referred to in Article 24(2) and listed in Annex X, ChapterC, point 4.
2. Each Member State shall inform the Commission and the other
Member States, within the Standing Veterinary Committee, of theemergence of a TSE other than BSE.
3. All official investigations and laboratory examinations shall be
recorded in accordance with Annex III, Chapter B.
4. Member States shall submit an annual report to the Commission
covering at least the information referred to in Annex III, Chapter B,Part I. The report for each calendar year shall be submitted at the latestby 31 March of the following year. The Commission shall present asummary of the national reports covering at least the information
referred to in Annex III, Chapter B, Part II, to the Standing Veterinary
Committee within three months of the receipt of the said reports.
Article 7
Prohibitionsconcerninganimalfeeding
1. The feeding to ruminants of protein derived from mammals is
prohibited.
2. Furthermore, the prohibition referred to in paragraph 1 shall be
extended to animals and products of animal origin in accordance withpoint 1 of Annex IV.
3. Paragraphs 1 and 2 shall apply without prejudice to the provisions
set out in point 2 of Annex IV.
4. Member States, or regions thereof, in category 5 shall not be
permitted to export or store feed intended for farmed animals whichcontains protein derived from mammals or feed intended for mammals,except for dogs and cats, which contains processed protein derived
from mammals.
Third countries, or regions thereof, in category 5 shall not be permitted
to export to the 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 frommammals.
5. Detailed rules for the implementation of this Article, in particular
rules on the prevention of cross-contamination and on the methods ofsampling and analysis required to check compliance with this Article,shall be adopted in accordance with the procedure referred to in Article24(2).2001R0999 — EN — 01.10.2003 — 008.002 — 9
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Article 8
Specifiedriskmaterial
1. The specified risk material shall be removed and destroyed in
accordance with points 2, 3, 4 and 8 of Annex 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 Annex
V. It may not be imported into the Community. Transit of specifiedrisk material through Community territory must take place in accor-dance with the requirements of Article 3 of Directive 91/496/EEC.
2. Paragraph 1 shall not apply to tissues from animals which have
undergone an alternative test approved for that distinct purpose inaccordance with the procedure referred to in Article 24(2) and listedin Annex X, Chapter C, point 5, and applied under the conditions listed
in point 5 of Annex V — and where the results of the test were nega-
tive.
The Member States which authorise that alternative test must inform
the other Member States and the Commission.
3. In Member States, or regions thereof, which are placed in cate-
gories 2, 3, 4 and 5 referred to in Annex II, Chapter C, the laceration,
after stunning, of central nervous tissue by means of an elongated rod-
shaped instrument introduced into the cranial cavity shall not be usedon bovine, ovine or caprine animals whose meat is destined for humanor animal consumption.
4. The data relating to age set out in Annex V shall be adjusted
regularly. Such adjustments shall be based on the latest proven scien-tific findings concerning the statistical probability of the occurrence ofa TSE in the relevant age groups of the Community's bovine, ovine andcaprine population.
5. By way of derogation from paragraphs 1 to 4, a decision may be
adopted, in accordance with the procedure referred to in Article 24(2),with regard to the date of effective enforcement of Article 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 regionplaced in category 3 or 4, in order to limit the application of thisArticle to animals born before that date in those countries or regions.
Similarly, by way of derogation from paragraphs 1 to 4, after consulta-
tion of the appropriate scientific committee and on the basis of anassessment of the incident, propagation and human exposure risk, adecision may be adopted in accordance with the procedure referred to
in Article 24(2) to allow the use for food, feed and fertilisers of
vertebral column and dorsal root ganglia from bovine animals in orcoming from each country or region thereof placed in category 5.
6. Rules for the implementation of this Article shall be adopted in
accordance with the procedure referred to in Article 24(2).
Article 9
Products of animal origin derived from or containing ruminant
material
1. The products of animal origin listed in Annex VI shall not be
produced from ruminant material from countries or regions thereofwhich are placed in category 5 unless they are produced in accordancewith the production processes approved in accordance with the proce-dure referred to in Article 24(2).
2. Bones of the head, and vertebral columns of bovine, ovine and
caprine animals from countries, or regions thereof, which are placedin categories 2, 3, 4 or 5, shall not be used for the production of
mechanically recovered meat.
3. Paragraphs 1 and 2 shall not apply, in the light of the criteria set
out in point 5 of Annex V, to ruminants which have undergone an2001R0999 — EN — 01.10.2003 — 008.002 — 10
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alternative test which has been recognised in accordance with the
procedure referred to in Article 24(2), where the results of the testwere negative.
4. Rules for the implementation of this Article shall be adopted in
accordance with the procedure referred to in Article 24(2).
Article 10
Educationprogrammes
1. Member States shall ensure that staff of the competent authority,
of diagnostic laboratories and colleges of agriculture and veterinarymedicine, 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 staffresponsible for carrying out checks, in interpreting laboratory findingsrelating to TSEs.
2. To ensure effective implementation of the education programmes
provided for in paragraph 1, financial assistance from the Community
may be granted. The amount of such assistance shall be determined in
accordance with the procedure referred to in Article 24(2).
CHAPTER IV
CONTROLANDERADICATIONOFTSEs
Article 11
Notification
Without prejudice to Directive 82/894/EEC (1), the Member States shall
ensure that any animal suspected of being infected by a TSE is notifiedimmediately to the competent authorities.
Member States shall regularly inform each other and the Commission
of the cases of TSE notified.
The competent authority shall without delay take the measures laid
down in Article 12 of this Regulation, together with any other neces-
sary measures.
Article 12
Measureswithrespect tosuspectanimals
1. Any animal suspected of being infected by a TSE shall be placed
under an official movement restriction until the results of a clinical andepidemiological 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 a Member State,
all other bovine animals from that holding shall be placed under anofficial movement restriction until the results of the examination areavailable.
If BSE is suspected in an ovine or caprine animal at a holding in a
Member State on the basis of objective evidence such as the results of
tests capable of differentiating in a practical way between the variousTSEs, all other ovine and caprine animals from that holding shall beplaced under an official movement restriction until the results of theexamination 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 competent authority maydecide that only the animal suspected of being infected shall be placed2001R0999 — EN — 01.10.2003 — 008.002 — 11
(1) Council Directive 82/894/EEC of 21 December 1982 on the notification of
animal diseases within the Community (OJ L 378, 31.12.1982, p. 58). Direc-
tive as last amended by Commission Decision 2000/556/EC (OJ L 235,
19.9.2000, p. 27).
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under an official movement restriction. If considered necessary, the
competent authority may also decide that other holdings or only theholding of exposure shall be placed under official control depending
on the epidemiological information available.
Under the procedure referred to in Article 24(2) and by way of deroga-
tion from the requirements of the second, third and fourth
subparagraphs of this paragraph, a Member State may be exempted
from the application of official restrictions on the movement of animalsif it applies measures offering equivalent safeguards.
2. Where the competent authority 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 competent authoritymay determine shall be removed and sent to an officially approvedlaboratory, the national reference laboratory provided for in Article19(1) or the Community reference laboratory provided for in Article19(2), for examination in accordance with the testing methods laid
down in Article 20.
3. All parts of the body of the suspect animal including the hide
shall be retained under official control until a negative diagnosis hasbeen made or shall be destroyed in accordance with Annex V, point 3
or 4.
4. Rules for the implementation of this Article shall be adopted in
accordance with the procedure referred to in Article 24(2).
Article 13
Measuresfollowingconfirmationofthepresence ofaTSE
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 Annex V apart from material retained for records
in accordance with Annex III, Chapter B, III, 2;
(b) an inquiry shall be carried out to identify all animals at risk in
accordance with Annex VII, point 1;
(c) all animals and products of animal origin referred to in Annex VII,
point 2, that have been identified as being at risk by the inquiry
referred to in (b), shall be killed and completely destroyed in accor-dance with Annex V, points 3 and 4.
By way of derogation from this paragraph, Member States may apply
other measures offering an equivalent level of protection, if those
measures have been approved in accordance with the procedurereferred to in Article 24(2).
2. Pending the implementation of the measures referred to in para-
graph 1(b) and (c), the holding on which the animal was present when
the presence of a TSE was confirmed shall be placed under officialcontrol and all movement of animals susceptible to TSEs and productsof animal origin derived from them from or to the holding shall besubject to authorisation by the competent authority, 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 the holding
where the animal was exposed to the TSE, the competent authority
may decide that both holdings or only the holding of exposure shallbe placed under official control.
3. Member States which have implemented a substitute scheme
offering equivalent safeguards provided for in the fifth subparagraph
of Article 12(1) may, by way of derogation from the requirements ofparagraph 1(b) and (c), be exempted in accordance with the procedurereferred to in Article 24(2) from the requirement to apply officialrestrictions on the movement of animals and from the requirement tokill and destroy animals.2001R0999 — EN — 01.10.2003 — 008.002 — 12
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4. Owners shall be compensated without delay for the loss of the
animals that have been killed or products of animal origin destroyedin accordance with Article 12(2) and paragraph 1(a) and (c) of this
Article.
5. Without prejudice to Directive 82/894/EEC, the confirmed
presence of any TSE other than BSE shall be notified to the Commis-
sion on an annual basis.
6. Rules for the implementation of this Article shall be adopted in
accordance with the procedure referred to in Article 24(2).
Article 14
Contingencyplan
1. Member States shall draw up— in accordance with the general
criteria of Community rules on the control of animal diseases — guide-
lines specifying the national measures to be implemented and
indicating competences and responsibilities where cases of TSE areconfirmed.
2. Where necessary to enable Community legislation to be applied
uniformly, the guidelines may be harmonised in accordance with theprocedure referred to in Article 24(2).
CHAPTER V
PLACINGONTHEMARKETANDEXPORT
Article 15
Liveanimals,theirsemen,embryosandova
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 Annex VIII, or, in the case of imports, tothe conditions laid down in Annex IX. The live animals and theirembryos and ova shall be accompanied by the appropriate animalhealth certificates as required by Community legislation, in accordance
with Article 17 or, in the case of imports, Article 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 Annex VIII, Chapter B.
3. Rules for the implementation of this Article shall be adopted in
accordance with the procedure referred to in Article 24(2).
Article 16
Placingonthemarketofproductsofanimalorigin
1. The following products of animal origin derived from healthy
ruminants shall not be subject to restrictions on placing on the marketor, if need be, export pursuant to this Article, to Annex VIII, Chapters
C and D, and to Annex IX, Chapters A, C, F and G:
(a) products of animal origin covered by Article 15, in particular
semen, embryos and ova;
(b) (i) raw milk within the meaning of Directive 92/46/EEC (
1);
(ii) milk for the manufacture of milk-based products within the
meaning of Directive 92/46/EEC;
(iii) heat-treated drinking milk within the meaning of Directive 92/
46/EEC;
(iv) di-calcium phosphate (without any trace of protein or fat);2001R0999 — EN — 01.10.2003 — 008.002 — 13
(1) Council Directive 92/46/EEC of 16 June 1992 laying down the health rules
for the production and placing on the market of raw milk, heat-treated milk
and milk-based products (OJ L 268, 14.9.1992, p. 1). Directive as last
amended by Directive 96/23/EC (OJ L 23.5.1996, p. 10).
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(v) hides and skins within the meaning of Directive 92/118/
EEC (1);
(vi) gelatine within the meaning of Directive 92/118/EEC, derived
from the hides and skins referred to in point (v);
(vii) collagen derived from the hides and skins referred to in point
(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 andcaprine animals which have not been subjected to a laceration of the
central nervous tissue as referred to in Article 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 MemberState 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 mammalswas 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 animalorigin listed in Annex VIII, Chapter C, and fulfilling the requirementsof Annex VIII, Chapter C. They must be accompanied by an animalhealth certificate issued by an official veterinarian certifying that they
have been produced in conformity with this Regulation.
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 thehighest category of the countries or regions in which it has stayedover 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 Article lays down
specific rules shall be accompanied by the appropriate animal healthcertificates or commercial documents as required by Community legis-
lation in accordance with Articles 17 and 18 or, if such certificates or
documents are not provided for in Community legislation, by a healthcertificate or commercial document the specimens of which shall beestablished in accordance with the procedure referred to in Article24(2).
6. For the purpose of import into the Community, products of
animal origin shall comply with the conditions laid down in AnnexIX, Chapters A, C, F and G.
7. In accordance with the procedure referred to in Article 24(2), the
provisions of paragraphs 1 to 6 may be extended to other products of
animal origin. Rules for the implementation of this Article shall be
adopted by the same procedure.
Article 17
Under the procedure referred to in Article 24(2), the health certificates
referred to in Annex F to Directive 64/432/EEC, Models II and III inAnnex E to Directive 91/68/EEC and the appropriate health certificates2001R0999 — EN — 01.10.2003 — 008.002 — 14
(1) Council Directive 92/118/EEC of 17 December 1992 laying down animal
health and public health requirements governing trade in and imports intothe Community of products not subject to the said requirements laid down
in specific Community rules referred to in Annex A(1) to Directive 89/662/
EEC and, as regards pathogens, in Directive 90/425/EEC (OJ L 62,
15.3.1993, p. 49). Directive as last amended by Commission Decision
1999/724/EC (OJ L 290, 12.11.1999, p. 32).
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laid down by Community legislation relating to trade in the semen,
embryos and ova of bovine, ovine or caprine animals shall be supple-mented, where necessary, by a reference to the category specifying the
classification of the Member State or region of origin given in accor-
dance with Article 5.
Appropriate commercial documents relating to trade in products of
animal origin shall be supplemented, where necessary, by a referenceto the category of the Member State or region of origin given by theCommission in accordance with Article 5.
Article 18
The appropriate health certificates relating to imports provided for by
Community legislation shall, under the procedure referred to in Article
24(2), be supplemented in respect of third countries classified in a cate-gory pursuant to Article 5 by the specific requirements laid down inAnnex IX, as soon as that classification decision has been taken.
CHAPTER VI
REFERENCE LABORATORIES, SAMPLING, TESTING AND
CONTROLS
Article 19
Reference laboratories
1. The national reference laboratories in each Member State and
their functions and duties shall be those indicated in Annex X, ChapterA.
2. The Community reference laboratory and its functions and duties
shall be those laid down in Annex X, Chapter B.
Article 20
Samplingandlaboratorymethods
1. Sampling and laboratory testing for the presence of a TSE shall
be carried out using the methods and protocols laid down in AnnexX, Chapter C.
2. Where necessary to ensure the uniform application of this Article,
implementing rules, including the method to confirm BSE in ovine andcaprine animals, shall be adopted in accordance with the procedure
referred to in Article 24(2).
Article 21
Communitycontrols
1. Experts from the Commission may make on-the-spot checks in
cooperation with the competent authorities of the Member States,insofar as is necessary for the uniform application of this Regulation.The Member State in whose territory checks are made shall providethe experts with all the assistance necessary for carrying out theirduties. The Commission shall inform the competent authority of the
results of the checks made.
The rules for the application of this Article, and in particular those
governing the procedure for cooperation with the national authorities,shall be adopted in accordance with the procedure referred to in Article24(2).
2. Community checks concerning third countries shall be made in
accordance with Articles 20 and 21 of Directive 97/78/EC.2001R0999 — EN — 01.10.2003 — 008.002 — 15
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CHAPTER VII
TRANSITIONALANDFINALPROVISIONS
Article 22
Transitionalmeasuresconcerningspecifiedriskmaterial
1. The provisions of Annex XI, Part A shall apply for a period of at
least six months from 1 July 2001 and shall cease to apply immediately
following the date of adoption of a decision in accordance with Article
5(2) or (4), on which date Article 8 shall enter into force.
2. The results of a conclusive statistical survey carried out in accor-
dance with Article 5(3) during the transitional period shall be used to
confirm or overturn the risk analysis conclusions referred to in Article
5(1), while taking account of the classification criteria defined by theOIE.
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 Article 24(2).
4. The minimum criteria to be met by this statistical survey shall be
those laid down in Part B of Annex XI.
Article 23
Amendmentoftheannexesandtransitionalmeasures
After consultation of the appropriate scientific committee on any ques-
tion which could have an impact on public health, the annexes shall beamended or supplemented and any appropriate transitional measuresshall be adopted in accordance with the procedure referred to in Article24(2).
In accordance with that procedure, transitional measures shall be
adopted for a period ending on 1 July 2005 at the latest, to permit thechangeover from the current arrangements to the arrangements estab-lished by this Regulation.
Article 24
Committees
1. The Commission shall be assisted by the Standing Veterinary
Committee. However, for matters exclusively concerning animalfeedingstuffs, the 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 paragraph, Articles 5 and 7 of
Decision 1999/468/EC shall apply, in compliance with Article 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 Article4(2) of this Regulation, 15 days.
3. Each Committee shall adopt its rules of procedure.
Article 25
Consultationofthescientific committees
The appropriate scientific committees shall be consulted on any matter
within the scope of this Regulation which could have an impact onpublic health.2001R0999 — EN — 01.10.2003 — 008.002 — 16
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Article 26
Entryintoforce
This Regulation shall enter into force on the day following its publica-
tion in the Official Journal of the European Communities .
It shall apply from 1 July 2001.
This Regulation shall be binding in its entirety and directly applicable
in all Member States.2001R0999 — EN — 01.10.2003 — 008.002 — 17
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ANNEX I
SPECIFICDEFINITIONS
1. For the purpose of this Regulation, the following definitions set out in Regu-
lation (EC) No 1774/2002 of the European Parliament and of the Council (1),
Regulation (EC) No 178/2002 of the European Parliament and of the
Council (2) and Council Directive 79/373/EEC (3) 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 Regulation (EC) No
178/2002;
(c) the definition of ‘complete feedingstuff’ in Article 2(d) of Directive 79/
373/EEC.
2. For the purpose of this Regulation, the following definitions shall also apply:
(a) ‘indigenous case of BSE’: means a case of bovine spongiform encepha-
lopathy 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 groupof bovine animals which were,
(i) born in the same herd as the affected bovine animal, and within 12
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 bovine animal consumed during the
first year of its life.2001R0999 — EN — 01.10.2003 — 008.002 — 18
(1) OJ L 273, 10.10.2002, p. 1.
(2) OJ L 31, 1.2.2002, p. 1.
(3) OJ L 86, 6.4.1979, p. 30.
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ANNEX II
DETERMINATIONOFBSESTATUS
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 guide-
lines in the table of Chapter A of Annex 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
factors:
— the consumption by bovine animals of meat and bone meal or greaves
derived from ruminants;
— the importation of meat and bone meal or greaves potentially contaminated
by a TSE or animal feed containing meat and bone meal 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
Definitionofcategories
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
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 bone meal 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, or2001R0999 — EN — 01.10.2003 — 008.002 — 19
▼B
(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 bone meal 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 bone
meal and greaves derived from ruminants has been banned and the ban
has been effectively enforced for at least eight years.
B. CATEGORY 2: BSE provisionally free country or region where no indi-
genous 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
bone meal 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
bone meal or greaves has been fed to ruminants, but the criteria in
Chapter A(c) have not been complied with for seven years.
C. 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 appro-
priate 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 bone meal 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 bone meal 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 twelve-month 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 bone meal 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.2001R0999 — EN — 01.10.2003 — 008.002 — 20
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D. 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 hundredcases 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.
E. 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.2001R0999 — EN — 01.10.2003 — 008.002 — 21
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ANNEX III
MONITORINGSYSTEM
CHAPTER A
I. MONITORING IN BOVINE ANIMALS
1.General
Monitoring in bovine animals shall be carried out in accordance with
the laboratory methods laid down in Annex X, Chapter C, point
3(1)(b).
2.Monitoringinanimalsslaughteredforhumanconsumption
2.1. All bovine animals over 24 months of age:
— subject to ‘special emergency slaughtering’ as defined in Article
2(n) of Council Directive 64/433/EEC (1), or
— slaughtered in accordance with Annex I, Chapter VI, point 28(c), to
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.
2.3. By way of derogation from point 2.2, and with regard to bovine
animals born, reared and slaughtered on its territory, Sweden may
decide to examine only a random sample. The sample shall comprise
at least 10000 animals per year.
3.Monitoringinanimalsnotslaughteredforhumanconsumption
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 Commission Regulation (EC) No
716/96 (2),
— 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 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
Regulation(EC)No716/96
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.Monitoringinotheranimals
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 countries2001R0999 — EN — 01.10.2003 — 008.002 — 22
(1) OJ 121, 29.7.1964, p. 2012/64
(2) OJ L 99, 20.4.1996, p. 14.
▼M9
with indigenous BSE, have consumed potentially contaminated
feedingstuffs or were born or derived from BSE infected dams.
6.Measuresfollowingtesting
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 Directive 64/433/EEC shall not be carried out on the
carcase 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 Annex 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 Annex 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 carcase immediately preceding the test-
positive carcase and two carcases immediately following the test-posi-
tive carcase on the same slaughterline shall be destroyed in accordance
with point 6.4, in addition to the test-positive carcase.
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 carcase.
II. MONITORING IN OVINE AND CAPRINE ANIMALS
1.General
Monitoring in ovine and caprine animals shall be carried out in accor-
dance with the laboratory methods laid down in Annex X, Chapter C,
point 3.2(b).
2.Monitoringinanimalsslaughteredforhumanconsumption
Animals over 18 months of age or which have more than two perma-
nent 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 estimated based on dentition, obvious
signs of maturity or other reliable information. Multiple sampling in
the same flock shall be avoided, where possible.
Member StateMinimum annual sample size
Slaughtered animals (1)
Belgium 3 750
Denmark 3 000
Germany 60000Greece 60000Spain 60000France 60000
Ireland 60000
Italy 60000Luxembourg 2502001R0999 — EN — 01.10.2003 — 008.002 — 23
▼M9
Member StateMinimum annual sample size
Slaughtered animals (1)
Netherlands 39000
Austria 8 200
Portugal 22500
Finland 1 900Sweden 5 250United Kingdom 60000
(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 theestimated 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.Monitoringinanimalsnotslaughteredforhumanconsumption
Animals over 18 months of age or which have more than two perma-
nent 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 reli-
able 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 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 StateMinimum annual sample size
Dead animals (1)
Belgium 450
Denmark 400
Germany 6000Greece 6000Spain 6000
France 6000
Ireland 6000Italy 60002001R0999 — EN — 01.10.2003 — 008.002 — 24
▼M9
Member StateMinimum annual sample size
Dead animals (1)
Luxembourg 30
Netherlands 5000
Austria 1100
Portugal 6000Finland 250Sweden 800
United Kingdom 6000
(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 popu-
lation. In those Member States with a smaller sheep population, the samplesize is calculated as 50 % of the estimated number of dead animals (esti-mated mortality 1%).
4.Monitoringininfectedflocks
From 1 October 2003, animals over 12 months or which have a perma-
nent incisor erupted through the gum, which are killed in accordance
with the provisions of Annex 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 flockMinimum sample size (1)
70 or less All eligible animals
80 6890 73100 78
120 86
140 92160 97180 101200 105
250 112
300 117350 121400 124
450 127
500 or more 150
(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 thetest population.2001R0999 — EN — 01.10.2003 — 008.002 — 25
▼M9
5.Monitoringinotheranimals
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 feeding-
stuffs,
— animals born or derived from TSE infected dams,— animals from flocks infected with TSE.
6.Measuresfollowingtestingofovineandcaprineanimals
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 Directive 64/433/EEC shall not be carried out on the
carcase 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 Annex
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 Annex 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 geno-
types 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 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 100animals 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 move-
ment restrictions in accordance with Article 12(1).
2. The number of suspected cases per animal species subject to laboratory
examination in accordance with Article 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 Article 12(1)
and (2).
4. The estimated size of each subpopulation referred to in Chapter A,
Section I, points 3 and 4.2001R0999 — EN — 01.10.2003 — 008.002 — 26
▼M9
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
subpopulation 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 subpopulation referred to in Chapter A, part II, points 7.1 and 7.2.
II. 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.
III. 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 Article 12(1),
— the number and outcome of clinical and epidemiological investiga-
tions as referred to in Article 12(1),
— the number and outcome of laboratory examinations as referred to in
Article 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.2001R0999 — EN — 01.10.2003 — 008.002 — 27
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ANNEX IV
ANIMALFEEDING
ExtensionoftheprohibitionprovidedforinArticle 7(1)
1. The prohibition provided for in Article 7(1) shall be extended to the
feeding:
(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 Article 7(1) and (2), and
specific conditions for the application of such derogations.
A. The prohibitions provided for in Article 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 accor-
dance with Article 19 of 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 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 Regulation (EC) No
1774/2002 and of feedingstuffs derived from such proteins, in
accordance with the conditions laid down in point E.
B. Conditions for the use of fishmeal and feedingstuffs containing fish-
meal 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 accor-
dance with Article 17 of Regulation (EC) No 1774/2002.
(b) Before release for free circulation in the Community, each
consignment of imported fishmeal shall be analysed in accordance
with Commission Directive 98/88/EC (1).
(c) Feedingstuffs containing fishmeal shall be produced in establish-
ments which do not produce feedingstuffs for ruminants and
which are authorised for this purpose by the competent authority.2001R0999 — EN — 01.10.2003 — 008.002 — 28
(1) OJ L 318, 27.11.1998, p. 45.
▼M10
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 facil-
ities where feedingstuffs containing fishmeal are
manufactured,
— bulk feedingstuffs destined for ruminants are kept in facil-
ities physically separate from facilities where bulkfishmeal 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 fish-
meal 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 feeding-
stuffs for ruminants. If the vehicle is subsequently used for the
transport of feedingstuffs intended for ruminants, it shall be thor-
oughly 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 fish-
meal 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.
C. Conditions for the use of hydrolysed proteins derived from non-rumi-
nants 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 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 hydrolysed2001R0999 — EN — 01.10.2003 — 008.002 — 29
▼M10
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 facil-
ities where feedingstuffs containing hydrolysed proteins
are manufactured,
— bulk feedingstuffs destined for ruminants are kept in facil-
ities 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 hydro-
lysed 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 trans-
ported by mean 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 hydro-
lysed 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 rumi-
nants.
D. Conditions for the use of dicalcium phosphate, tricalcium phosphate
and feedingstuffs containing such proteins in the feeding of non-rumi-
nant 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 Regulation (EC) No 1774/2002.
(b) Feedingstuffs containing dicalcium phosphate or tricalcium phos-
phate 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 phos-
phate 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 phos-
phate 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 phos-
phate 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 facil-
ities where feedingstuffs containing dicalcium phosphate
or tricalcium phosphate are manufactured,
— bulk feedingstuffs destined for ruminants are kept in facil-
ities physically separate 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,2001R0999 — EN — 01.10.2003 — 008.002 — 30
▼M10
— records detailing the purchases and uses of dicalcium phos-
phate 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 phos-
phate of animal origin — cannot be fed to ruminants’.
(d) Bulk feedingstuffs containing dicalcium phosphate or tricalcium
phosphate shall be transported by mean 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 accor-
dance with a procedure approved by the competent authority to
avoid cross-contamination.
(e) The use and storage of feedingstuffs containing dicalcium phos-
phate 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 dical-
cium phosphate or tricalcium phosphate in farms where ruminants
are kept, if they are satisfied that on-farm measures are imple-
mented to prevent that feedingstuffs containing dicalcium
phosphate or tricalcium phosphate are fed to ruminants.
E. 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 slaughter-
houses 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 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 recog-
nised 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 exception2001R0999 — EN — 01.10.2003 — 008.002 — 31
▼M10
of carnivorous fur producing animals, and which are authorised for
that purpose by the competent authority;
(d) the label, accompanying commercial document or health certifi-
cate, 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 trans-
port 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 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 this Regulation
within 60 days from the date of entry into force of this Regulation.
Any amendments to the list shall immediately be made available to
the other Member States and to the 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 competentauthority; 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 estab-
lishments 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.2001R0999 — EN — 01.10.2003 — 008.002 — 32
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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 expor-
tation, which includes an undertaking from the third country to
respect the final use and not to re-export 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
Commission and the other Member States of all terms and conditions
as agreed with the third country concerned, for the effective implemen-
tation of this Regulation, 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 fish-
meal, 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 Council Directive 95/53/EC (1),
to control compliance with its provisions and the provisions of this
Regulation. Where any presence of prohibited animal protein is
detected, Council Directive 95/53/EC shall apply.
F. The provisions on the production and the use of processed animal
protein of Regulation (EC) No 1774/2002 shall apply to the feeding-
stuffs covered by this Annex.2001R0999 — EN — 01.10.2003 — 008.002 — 33
(1) OJ L 265, 5.11.1995, p. 17.
▼B
ANNEX V
SPECIFIEDRISKMATERIAL
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 Article 5:
CATEGORIES 1 AND 2None.
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 perma-
nent 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, trigem-
inal 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 perma-
nent 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 Arti-
cles 3 and 7 of Directive 90/667/EEC (
1), under the supervision of a
designated agent appointed by the competent authority. Those establish-
ments 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 speci-
fied 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 Decision 92/562/EEC (2):
— by incineration;
— by co-incineration;
(ii) in accordance with at least the standards referred to in Annex I to
Decision 1999/534/EC (3), 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, without2001R0999 — EN — 01.10.2003 — 008.002 — 34
(1) Council Directive 90/667/EEC of 27 November 1990 laying down the veterinary rules
for the disposal and processing of animal waste, for its placing on the market and forthe prevention of pathogens in feedstuffs of animal or fish origin and amending Direc-tive 90/425/EEC (OJ L 363, 27.12.1990, p. 51). Directive as last amended by the 1994Act of Accession.
(
2) Commission Decision 92/562/EEC of 17 November 1992 on the approval of alternative
heat treatment systems for processing high-risk material (OJ L 359, 9.12.1992, p. 23).Decision as amended by the 1994 Act of Accession.
(
3) Council Decision 1999/534/EC of 19 July 1999 on measures applying to the processing
of certain animal waste to protect against transmissible spongiform encephalopathies
and amending Commission Decision 97/735/EC (OJ L 204, 4.8.1999, p. 37).
▼B
prior staining, or, as appropriate, removal of the specified risk materials, in
the circumstances set out in Article 3(2) of 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 slaugh-
terhouse 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 Annex 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 Directive 90/667/EEC, points
of sale to the consumer, landfill sites and other facilities for storage or incin-
eration.
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
Article 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 estab-
lishments 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 carcasses 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 Decision 97/735/EC (1), 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.2001R0999 — EN — 01.10.2003 — 008.002 — 35
(1) Commission Decision 97/735/EC of 21 October 1997 concerning certain protection
measures with regard to trade in certain types of mammalian animal waste (OJ L 294,28.10.1997, p. 7). Decision as amended by Council Decision 1999/534/EC (OJ L 204,
4.8.1999, p. 37).
▼B
ANNEX VI
STANDARDS FOR CERTAIN PRODUCTS OF ANIMAL ORIGIN
DERIVEDFROMORCONTAININGRUMINANTMATERIAL
The use of ruminant material for the production of the following products of
animal origin is prohibited as referred to in Article 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 Directive 90/667/EEC.2001R0999 — EN — 01.10.2003 — 008.002 — 36
▼M5
ANNEX VII
ERADICATION OF TRANSMISSIBLE SPONGIFORM ENCEPHALO-
PATHY
1. The inquiry referred to in Article 13(1)(b) must identify:
(a) in the case of bovine animals:
— all other ruminants on the holding of the animal in which the
disease was confirmed,
— where the disease was confirmed in a female animal, its progeny
born within two years prior to, or after, clinical onset of the disease,
— all animals of the cohort of the animal in which the disease was
confirmed,
— the possible origin of the disease,
— other animals on the holding of the animal in which the disease was
confirmed or on other holdings, which may have become infected
by the TSE agent or been exposed to the same feed or contamina-
tion source,
— the movement of potentially contaminated feedingstuffs, of other
material or any other means of transmission, which may have trans-
mitted 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 trans-
mitted the BSE agent to or from the holding in question.
2. The measures laid down in Article 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, from
1 October 2003, 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
— sheepcarrying 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 epidemiolo-
gical 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).2001R0999 — EN — 01.10.2003 — 008.002 — 37
▼M5
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 sheepof the ARR/ARR genotyp e;
(b) female sheepcarrying 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 sheepfrom the holding shall not be subject to
any restriction;
(b) sheepcarrying 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) sheepof other genotyp es 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 moni-
toring 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 upto two breeding years;
(b) allow ovine animals other than those specified in point 3 to be intro-
duced 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 Commission an account of the conditions and criteria used for
granting them.2001R0999 — EN — 01.10.2003 — 008.002 — 38
▼B
ANNEX VIII
PLACINGONTHEMARKETANDEXPORT
CHAPTER A
Conditionsforintra-Communitytradeinlive animals
I. CONDITIONS WHICH APPLY IRRESPECTIVE OF THE CATEGORY
OF THE MEMBER STATE OR THIRD COUNTRY OF ORIGIN OR RESI-
DENCE 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) from 1 October 2003, be animals of the ARR/ARR prion protein
genotype, as defined in Annex I of Commission Decision 2002/
1003/EC (1).
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 havebeen defined in accordance with the procedure referred to in Article
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 Commission, outlining in parti-
cular:
— the distribution of the disease in the Member State,
— the reasons for the program, taking into consideration the impor-
tance of the disease and the cost/benefit ratio,
— the geographical area in which the program will be imple-
mented,
— 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 Article 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 Article 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 Article 24(2). Amendments to the guarantees which have
been defined in accordance with point (ii) may be approved in
accordance with that procedure,2001R0999 — EN — 01.10.2003 — 008.002 — 39
(1) OJ L 349, 24.12.2002, p. 105.▼M5
▼M5
(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 Commission appropriate supporting documen-
tation, setting out in particular:
— the history of the occurrence of the disease in its territory,
— the results of surveillance testing based on serological, micro-
biological, 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 Article 24(2). Such guarantees
must not exceed those which the Member State implements nation-
ally,
(iii) the Member State concerned is to notify the 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 accor-
dance with the procedure referred to in Article 24(2).
II. CONDITIONS WHICH APPLY DEPENDING ON THE CATEGORY OF
THE MEMBER STATE OF ORIGIN OR RESIDENCE OF THE ANIMAL
DETERMINED IN ACCORDANCE WITH ANNEX II, CHAPTER C
1. Dispatch to other Member States is to follow the rules of Article 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 destina-
tion.
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 rumi-
nants 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.
CHAPTER B
Conditions relating to progeny of TSE suspect or confirmed animals
referred toinArticle15(2)
It shall be prohibited to place on the market the last-born 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
Conditionsforintra-Communitytradeincertainproductsofanimalorigin
I. The following products of animal origin are exempt from the prohibition
referred to in Article 16(3), provided that they are derived from bovine
animals that satisfy the requirements of Parts II or III below:
— fresh meat;
— minced meat;2001R0999 — EN — 01.10.2003 — 008.002 — 40
▼B
▼B
— meat preparations;
— meat products;— petfood which is destined for domestic carnivores.
Date-based Scheme
II. 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 Article 16(3) when they are obtained from
animals born after the date from which the animal feeding standards laid
down in Article 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 eartag
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 this Regulation,
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 certifi-
cates issued. If dispatch has already taken place, the competent
authority must notify the competent authority of the place of destina-
tion. 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 Date-based 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, prescap-
ular, axilliary, caudal and deepcervical.
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 corre-
lated with the eartag 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;2001R0999 — EN — 01.10.2003 — 008.002 — 41
▼B
(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 trace-
ability 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.
Certified herd Scheme
III. 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 in category 5, may be marketed
in accordance with the second subparagraph of Article 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 condi-
tions 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 groupof animals forming a sep arate and distinct unit,
that is a group of animals which is managed, housed and kept sepa-
rately from any other groupof 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 estab-
lished 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;2001R0999 — EN — 01.10.2003 — 008.002 — 42
▼B
(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 this
Regulation, 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 this Regulation,
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 certi-
ficates issued. If dispatch has already taken place, the competent
authority must notify the competent authority of the place of destina-
tion. 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, prescap-
ular, axilliary, caudal and deepcervical.
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 compu-
terised 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 carcasses must have individual numbers corre-
lated 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 establishment11. 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 trace-
ability 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.2001R0999 — EN — 01.10.2003 — 008.002 — 43
▼B
CHAPTER D
Conditionsapplicabletoexports
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 this
Regulation for intra-Community trade.2001R0999 — EN — 01.10.2003 — 008.002 — 44
▼B
ANNEX IX
IMPORTATION INTO THE COMMUNITY OF LIVE ANIMALS,
EMBRYOS,OVAANDPRODUCTSOFANIMALORIGIN
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
this Regulation 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 Annex II, Chapter C, to be placed in that cate-
gory.
CHAPTER B
Importsofbovineanimals
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 certifi-
cate 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 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 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 rumi-
nants with proteins derived from mammals has been effectively
enforced.
C. 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 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 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 rumi-
nants with proteins derived from mammals has been effectively
enforced.
D. 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 that:
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;2001R0999 — EN — 01.10.2003 — 008.002 — 45
▼B
(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 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
Importsoffreshmeatandproductsofbovineanimalorigin
A. Imports of fresh meat (on the bone or deboned) 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.
B. Imports of fresh meat (on the bone or deboned) 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 Community do not contain or are not derived from specified risk
material referred to in Annex V or mechanically recovered meat
obtained from the bone of the head or vertebral column.
C. Imports of fresh meat (on the bone or deboned) 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 Community do not contain or are not derived from specified risk
material referred to in Annex 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, Annex VIII. These imports
are to be subject to the presentation of an international health certificate
attesting that:
1. they fulfil the conditions of Article 16(2) and those set out in sections II
or III of Chapter C of Annex VIII;
2. the meat products intended for export to the 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 Annex V;
3. a system is in operation enabling the fresh meat and products of bovine
animal origin intended for export to the 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 Community originate:
(a) were identified by a permanent identification system enabling them to
be traced back to the dam and herd of origin;2001R0999 — EN — 01.10.2003 — 008.002 — 46
▼B
(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 effec-
tively 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
Importsofbovineembryosandova
A. 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 certi-
ficate 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 Directive 89/556/EC (1).
B. 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 certi-
ficate 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 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 Directive 89/556/EEC.
C. 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 that:
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 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 effec-
tively 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;2001R0999 — EN — 01.10.2003 — 008.002 — 47
(1) Council Directive 89/556/EEC of 25 September 1989 on animal health conditions
governing intra-Community trade in importation from third countries of embryos ofdomestic animals of the bovine species (OJ L 302, 19.10.1989, p. 1). Directive as last
amended by Commission Decision 94/113/EC (OJ L 53, 24.2.1994, p. 23).
▼B
3. the ova/embryos were collected, processed and stored in conformity with
the provisions of Annexes A and B to 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 certi-
ficate 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 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 confor-
mity with the provisions of Annexes A and B to Directive 89/556/EEC.
CHAPTER E
Importsofovineandcaprineanimals
Ovine and caprine animals imported into the Community after 1 October 2003
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 Annex VIII;
(b) or they are sheep of the ARR/ARR prion protein genotype, as defined in
Annex I to 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
Annex VIII, they shall comply with the additional guarantees, general or
specific, which have been defined in accordance with the procedure referred to
in Article 24(2).
CHAPTER F
Imports into the Community from third countries or regions thereof, placed in
category 5, of the products of animal origin referred to in Annex VIII, Chapter
C, in accordance with Article 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 accor-
dance with the standards referred to in 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 Community legislation, are to be supplemented by a declaration2001R0999 — EN — 01.10.2003 — 008.002 — 48
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▼B
▼B
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 transmis-
sible 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.’2001R0999 — EN — 01.10.2003 — 008.002 — 49
▼B
ANNEX X
REFERENCE LABORATORIES, SAMPLING AND LABORATORY
ANALYSISMETHODS
CHAPTER A
Nationalreference 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 identi-
fying the strain-type of the agent, it shall set up a procedure to ensure
that the identification of the strain is referred to the Community refer-
ence laboratory;
(b) verify diagnostic methods used in regional diagnostic laboratories;
(c) be responsible for coordination 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 corre-
sponding tissues containing such agents, coming from cases
confirmed in the Member State;
— is to ensure confirmation of results obtained in diagnostic labora-
tories designated by the Member State;
(d) is to cooperate with the 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 Commu-
nity 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
A-2340 Mödling
Belgium: CERVA-CODA-VAR
Centre d'Étude et de Recherches Vétérinaires et
Agrochimiques
Centrum voor Onderzoek in Diergeneeskunde
en Agrochemie
Veterinary and Agrochemical Research Centre
Groeselenberg 99
B-1180 Bruxelles
Denmark: Danish Veterinary Laboratory
Bülowsvej 27
DK-1790 Copenhagen V
Finland: Eläinlääkintä- ja elintarvikelaitos
Hämeentie 57
FIN-00550 Helsinki
France: Agence Française de Sécurité Sanitaire des
Aliments
Laboratoire de pathologie bovine
31, avenue Tony Garnier
BP 7033
F-69342 Lyon Cedex
Germany: Bundesforschungsanstalt für Viruskrankheiten
der Tiere
Anstaltsteil Insel Riems
Boddenblick 5A
D-17498 Insel Riems2001R0999 — EN — 01.10.2003 — 008.002 — 50
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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
I-148-10150 Torino
Luxembourg: CERVA-CODA-VAR
Centre d'Étude et de Recherches Vétérinaires et
Agrochimiques
Centrum voor Onderzoek in Diergeneeskunde
en Agrochemie
Veterinary and Agrochemical Research Centre
Groeselenberg 99
B-1180 Bruxelles
Netherlands: Instituut voor Dierhouderij en Diergezondheid,
ID-DLO Lelystad
Edelhertweg 15
Postbus 658200 AB Lelystad
Netherlands
Portugal: Laboratório Nacional de Investigação Veter-
inária
Estrada de Benfica, 701
P-1500 Lisboa
Spain: Laboratorio de la Facultad de Veterinaria
Departamento de Patología Animal (Anatomía
Patológica)
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 Anímal
(CISA)
Crta, De Algete al Casar de Talamanca
28130 Valdeolmos (Madrid)
Spain
(TSEs other than BSE or scrapie)
Sweden: National Veterinary Institute
S-751 89 Uppsala
United Kingdom Veterinary Laboratories Agency
Woodham Lane
New Haw
Addlestone
Surrey KT15 3NB
United Kingdom2001R0999 — EN — 01.10.2003 — 008.002 — 51
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▼B
CHAPTER B
Communityreference laboratory
1. The Community reference laboratory for TSEs is:
The Veterinary Laboratories Agency
Woodham Lane
New Haw
AddlestoneSurrey KT15 3NB
United Kingdom
2. The functions and duties of the Community reference laboratory are:
(a) to coordinate, in consultation with the 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 upand retaining a collection of corresp onding tissues
containing the agents and strains of TSEs;
— organising periodic comparative tests of diagnostic procedures at
Community level;
— collecting and collating data and information on the methods of
diagnosis used and the results of tests carried out in the Commu-
nity;
— characterising isolates 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 preven-
tion 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 diag-
nostic 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 confir-
matory 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 Community.
CHAPTER C
Samplingandlaboratorytesting
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
theManual of standards for diagnostic tests and vaccines of the Interna-
tional 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 Article 12(2) shall be subject to a histopathological exam-
ination as laid down in the latest edition of the Manual, except where2001R0999 — EN — 01.10.2003 — 008.002 — 52
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▼M1
the material is autolysed. Where the result of the histopathological
examination is inconclusive or negative or where the material is auto-
lysed, the tissues shall be subjected to an examination by one of the
other diagnostic methods laid down in the Manual (immunocytochem-
istry, 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 Annex 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 offi-
cial 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 posi-
tive, or
— the result of another diagnostic method mentioned under (a) is posi-
tive.
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 Article 12(2) shall be subject to a histo-
pathological 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 examina-
tion by immunocytochemistry 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 Annex III, Chapter A, Section II (Moni-
toring in ovine and caprine animals) shall be examined by a rapid test.
When the result of the rapid test is inconclusive or positive, the brain-
stem shall immediately be sent to an official laboratory for
confirmatory examinations by immunocytochemistry or immuno-blot-
ting, 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 histo-
pathological examination of brain tissue. The competent authority may
also require laboratory tests such as immunocytochemistry, immuno-blot-
ting, demonstration of characteristic fibrils by electron microscopy orother 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 incon-
clusive. 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.2001R0999 — EN — 01.10.2003 — 008.002 — 53
▼M7
4. Rapid tests
For the purposes of carrying out the rapid tests in accordance with Article
5(3) and Article 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 PrPRescarried 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 this Regulation,
— microplate based immunoassay (ELISA) which detects protease-resis-
tant PrPReswith monoclonal antibodies (Prionics-Check LIA test),
— automated conformation-dependent immunoassay comparing the reac-
tivity of a detection antibody to the protease-sensitive and protease-
resistant forms of PrPSc(some fraction of the protease-resistant PrPScis
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 Community reference laboratory, which ensures that
the test performance does not change. The producer must provide the test
protocol to the Community reference laboratory.
Modifications to the rapid test or to the test protocol may only be made
following advance notification to the Community reference laboratory and
provided that the Community reference laboratory finds that the modifica-
tion does not reduce the sensitivity, specificity or reliability of the rapid
test. That finding shall be communicated to the Commission and to the
national reference laboratories.
5. Alternative tests
(To be defined)2001R0999 — EN — 01.10.2003 — 008.002 — 54
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ANNEX XI
TRANSITIONALMEASURESREFERREDTOINARTICLES22AND23A.Concerning specified risk material, mechanically recovered meat and
slaughteringtechniques
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 trans-
verse 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 intes-
tines 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 this Regulation in the light of the
statistical probability of the occurrence of BSE in the relevant age
groups of the Community's bovine population, based on the results
of BSE monitoring as established by Chapter A.I of Annex 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 trigeminalganglia; 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 accor-
dance with the procedure referred to in Article 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 Commission regarding point (a)
or (b), as appropriate.
Member States benefiting from this derogation shall, in addition to the
requirements laid down in Annex III, Chapter A, section I, ensure thatone of the approved rapid tests listed in Annex 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 Azores.
Experts from the Commission may carry out on-the-spot checks to
further verify the submitted evidence in accordance with Article 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.2001R0999 — EN — 01.10.2003 — 008.002 — 55
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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 (1),
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 prop-
erly sealed in accordance with the second indent,
— without prejudice to general rules on hygiene, specific working instruc-
tions 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 contam-
ination 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 point 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 carcases or parts of carcases in
butcher shops specifically authorised, monitored and registered for this
purpose;2001R0999 — EN — 01.10.2003 — 008.002 — 56
(1) OJ L 273, 10.10.2002, p. 1.
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(c) harvesting of head meat from bovine 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 brain-
stem 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 speci-
fically 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 imple-
mentation of the measures to reduce contamination;
the harvesting of head meat from bovine heads in cutting plants specifi-
cally 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 other-
wise 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 in point 5(c).
Member States shall in particular set up a system to ensure and check that:
(a) specified risk material used for purposes authorised pursuant to Article
1(2) and to Regulation (EC) No 1774/2002 are used solely for
authorised purposes;
(b) specified risk material is disposed of in accordance with Regulation
(EC) No 1774/2002.
13. Member States may decide to allow dispatch of heads or carcases
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, carcases, half carcases or half carcases 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 agreement2001R0999 — EN — 01.10.2003 — 008.002 — 57
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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 measures:
(a) when removal of the vertebral column is not required, carcases or
wholesale cuts of carcases of bovine animals containing vertebral
column, shall be identified by a blue stripe on the label referred to in
Regulation (EC) No 1760/2000;
(b) a specific indication of the number of bovine carcases or wholesale cuts
of carcases, 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 Directive 64/433/EEC or to the document referred to in Article 1(2)
of Commission Decision 93/13/EEC (1), as applicable;
(c) butcher shops shall keep, for at least one year, the commercial docu-
ments referred to in (b).
15. (a) The products of animal origin listed below shall be subject to the condi-
tions laid down in (b) on import into the Community:
— the specified risk material referred to in point 1(a),
— fresh meat: the meat defined by Directive 64/433/EEC,— minced meat and meat preparations: the minced meat and meat
preparations defined by Directive 94/65/EC (
2),
— meat products: the meat products defined by Directive 77/99/
EEC (3),
— other products of animal origin: other products of animal origin as
defined by Directive 77/99/EEC,
— rendered fats as referred to in Regulation (EC) No 1774/2002,— gelatine as referred to by Directive 92/118/EEC and Regulation
(EC) No 1774/2002,
— pet food as referred to in Regulation (EC) No 1774/2002,— blood products as referred to in Regulation (EC) No 1774/2002— the processed animal protein referred to in Regulation (EC) No
1774/2002,
— bones and bone products as referred to in Regulation (EC) No 774/
2002,
— category 3 material as referred to in 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 mate-
rial from bovine, ovine or caprine animals are imported into the
Community from third countries or regions thereof, the health certifi-
cates 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 Regulation
(EC) No 999/2001 produced after 31 March 2001, or mechanically
recovered meat obtained from bones of bovine, ovine or caprine
animals produced after 31 March 2001. After 31 March 2001 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 elon-
gated rod-shaped instrument introduced into the cranial cavity.
Carcases, half carcases and quarter carcases may contain vertebral
column on import;2001R0999 — EN — 01.10.2003 — 008.002 — 58
(1) OJ L 9, 15.1.1993, p. 3.
(2) Council Directive 94/65/EC of 14 December 1994 laying down the requirements for the
production and placing on the market of minced meat and meat preparations (OJ L 368,31.12.1994, p. 10).
(
3) Council Directive 77/99/EEC of 21 December 1976 on health problems affecting intra-
Community trade in meat products (OJ L 26, 31.1.1977, p. 85). Directive as last
amended by Council Directive 97/76/EC (OJ L 10, 16.1.1998, p. 25).
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or (1)
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
— Costa Rica
— El Salvador— Iceland— Namibia— New Zealand— Nicaragua— Panama— Paraguay— Singapore— Swaziland— Uruguay— Vanuatu.
(*) Delete one of these as appropriate.’
D.Concerningplacingonthemarketandexport
1. The following provisions remain in force as transitional measures:
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.
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 Council Decision
98/256/EC.
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.
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 Decision 98/653/
EC.
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 Decision 98/653/EC.
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 Decision 98/653/EC.
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 interna-
tional 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 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.2001R0999 — EN — 01.10.2003 — 008.002 — 59
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3. Point 2 shall not apply to imports of bovine animals born and continuously
reared in the following countries:
Argentina
AustraliaBotswana
Brazil
ChileCosta Rica
El Salvador
IcelandNamibiaNew-Zealand
Nicaragua
PanamaParaguaySingapore
Swaziland
UruguayVanuatu.2001R0999 — EN — 01.10.2003 — 008.002 — 60